id|nct_id|outcome_id|non_inferiority_type|non_inferiority_description|param_type|param_value|dispersion_type|dispersion_value|p_value_modifier|p_value|ci_n_sides|ci_percent|ci_lower_limit|ci_upper_limit|ci_upper_limit_na_comment|p_value_description|method|method_description|estimate_description|groups_description|other_analysis_description|ci_upper_limit_raw|ci_lower_limit_raw|p_value_raw
73897311|NCT01012219|147327683|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.23|||||TWO_SIDED|90.0|0.96|1.56||||||||1.56|0.96|
73897312|NCT02204124|147327684|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
73897313|NCT02204124|147327685|SUPERIORITY|||||||0.513|||||||Chi-squared|||||||0.513
73897314|NCT02204124|147327688|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
73897315|NCT02204124|147327689|SUPERIORITY|||||||0.132|||||||Chi-squared|||||||0.132
73897316|NCT02204124|147327690|SUPERIORITY|||||||0.975|||||||Chi-squared|||Statistical analysis #1 is for readmission||||0.975
73897317|NCT02204124|147327690|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #2 is for wound infection.||||0.401
73897318|NCT02204124|147327690|SUPERIORITY|||||||0.975|||||||Chi-squared|||Statistical analysis #3 is for gastroparesis.||||0.975
73897319|NCT02204124|147327690|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #4 is for pancreatic fistula.||||0.401
73897320|NCT02204124|147327690|SUPERIORITY|||||||0.219|||||||Chi-squared|||Statistical analysis #5 is for intraabdominal abscess.||||0.219
73897321|NCT02204124|147327690|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #6 is for anastomotic leakage.||||0.401
73897322|NCT02204124|147327690|SUPERIORITY|||||||0.219|||||||Chi-squared|||Statistical analysis #7 is for blood product transfusion (anemia).||||0.219
73897323|NCT01350544|147327697|SUPERIORITY||Odds Ratio (OR)|0.79||||0.005|TWO_SIDED|95.0|0.69|0.91||a priori threshold for significance for p \< .05|Mixed Models Analysis|||We used generalized linear mixed models predicting adherence at baseline and 1.5-, 3-, 4.5-, and 6-months post-baseline, with intervention , time, interaction between intervention and time, medical and socio-demographic covariates, and baseline viral load. Sample size was determined with a power analysis assuming .80 power and an alpha level of .05 that would allow for detection of a small-to-medium effect size in adherence between arms.||0.91|0.69|.005
73897324|NCT00594425|147327704|SUPERIORITY_OR_OTHER||% success rate|5.53||||0.5288|TWO_SIDED|95.0|-7.97|19.04||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||19.04|-7.97|0.5288
73897325|NCT00594425|147327704|SUPERIORITY_OR_OTHER||% success rate|3.95||||0.7539|TWO_SIDED|95.0|-8.79|16.69||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||16.69|-8.79|0.7539
73897326|NCT00594425|147327705|SUPERIORITY_OR_OTHER||Least squares mean|-2.64||||0.3236|TWO_SIDED|95.0|-7.91|2.63||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||2.63|-7.91|0.3236
73897327|NCT00594425|147327705|SUPERIORITY_OR_OTHER||Least squares mean|-1.19||||0.6657|TWO_SIDED|95.0|-6.64|4.26||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||4.26|-6.64|0.6657
73897328|NCT00594425|147327733|SUPERIORITY_OR_OTHER||%success rate|3.09||||0.7889|TWO_SIDED|95.0|-11.16|17.33||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||17.33|-11.16|0.7889
73897329|NCT00594425|147327733|SUPERIORITY_OR_OTHER||Percent success|5.48||||0.888|TWO_SIDED|95.0|-10.15|21.11||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||21.11|-10.15|0.8880
73897330|NCT00594425|147327734|SUPERIORITY_OR_OTHER||Least squares mean|-0.33||||0.9151|TWO_SIDED|95.0|-6.53|5.86||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||5.86|-6.53|0.9151
73897331|NCT00594425|147327734|SUPERIORITY_OR_OTHER||Least squares mean|-1.18||||0.7233|TWO_SIDED|95.0|-7.81|5.45||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||5.45|-7.81|0.7233
73897332|NCT01323855|147327820|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio (GMR) is contained within the interval \[0.50, 2.00\]|GMR|1.19|||||TWO_SIDED|90.0|0.54|2.62|||||Severe CRI/Healthy|||2.62|0.54|
74080417|NCT03428750|147713412|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.006
73897333|NCT01323855|147327821|NON_INFERIORITY_OR_EQUIVALENCE|GMR is contained within the interval \[0.50, 2.00\]|GMR|1.3|||||TWO_SIDED|90.0|0.59|2.87|||||Moderate CRI/Healthy|||2.87|0.59|
73897334|NCT01323855|147327822|NON_INFERIORITY_OR_EQUIVALENCE|GMR is contained within the interval \[0.50, 2.00\]|GMR|2.63|||||TWO_SIDED|90.0|1.38|5.04|||||Mild CRI/Healthy|||5.04|1.38|
74080418|NCT03428750|147713413|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73897335|NCT02012582|147327929|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||Mixed model analysis for TIL with the patient as random effect and study day, cohort, treatment, and interaction between study day and treatment as fixed effects.|Mixed Models Analysis|||Placebo versus pooled VAS203 Arms/Groups||||<0.04
73897336|NCT02012582|147327930|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Placebo versus pooled VAS203 Arms/Group||||<0.01
73930687|NCT03238911|147391291|SUPERIORITY||Mean Difference (Final Values)|2.09||||0.0379|TWO_SIDED|95.0|0.12|4.05|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||4.05|0.12|0.0379
74080419|NCT03428750|147713414|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.001
73958510|NCT03224299|147452209|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.44|0.69||||||"Abdomen 10 minutes~Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.69|-0.44|
73836080|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|115.78|||||TWO_SIDED|90.0|107.04|125.22|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||125.22|107.04|
73836081|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Astellas Ratio|103.7|||||TWO_SIDED|90.0|95.91|112.12|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.12|95.91|
73836082|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|99.79|||||TWO_SIDED|90.0|92.3|107.89|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.89|92.30|
73836083|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio|103.65|||||TWO_SIDED|90.0|95.83|112.11|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and Cmax parameters||112.11|95.83|
73836084|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X100|101.7|||||TWO_SIDED|90.0|94.03|110.0|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and parameters||110.0|94.03|
74019884|NCT05900115|147591917|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.77|TWO_SIDED||||||Regression, Linear|||||||0.77
74019885|NCT05900115|147591918|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.78|TWO_SIDED||||||Regression, Linear|||||||0.78
73836085|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddys Ratio X 100|111.64|||||TWO_SIDED|90.0|103.26|120.7|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.70|103.26|
73836086|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|116.02|||||TWO_SIDED|90.0|107.27|125.49|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||125.49|107.27|
73836087|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|111.7|||||TWO_SIDED|90.0|103.27|120.81|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.81|103.27|
73836088|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|113.84|||||TWO_SIDED|90.0|105.3|123.08|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||123.08|105.30|
73836089|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan Ratio X 100|103.92|||||TWO_SIDED|90.0|96.08|112.4|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.40|96.08|
73836090|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Panacea Ratio x 100|100.05|||||TWO_SIDED|90.0|92.5|108.21|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||108.21|92.50|
73836091|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|101.97|||||TWO_SIDED|90.0|94.28|110.29|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||110.29|94.28|
73836092|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|96.28|||||TWO_SIDED|90.0|89.05|104.09|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.09|89.05|
73836093|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|98.12|||||TWO_SIDED|90.0|90.72|106.12|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||106.12|90.72|
73836094|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|101.92|||||TWO_SIDED|90.0|94.27|110.19|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||110.19|94.27|
74019886|NCT05900115|147591919|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.13|STANDARD_ERROR_OF_MEAN|0.12||0.28|TWO_SIDED||||||Regression, Linear|||||||0.28
73836095|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|109.75|||||TWO_SIDED|90.0|100.42|119.25|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||119.25|100.42|
73836096|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|99.76|||||TWO_SIDED|90.0|91.28|109.03|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||109.03|91.28|
73836097|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|101.63|||||TWO_SIDED|90.0|92.99|111.06|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||111.06|92.99|
73836098|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|106.2|||||TWO_SIDED|90.0|97.17|116.06|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||116.06|97.17|
73836099|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|104.09|||||TWO_SIDED|90.0|95.25|113.75|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||113.75|95.25|
73836100|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddy Ratio X 100|110.02|||||TWO_SIDED|90.0|100.66|120.24|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.24|100.66|
73897337|NCT04740905|147327935|NON_INFERIORITY|If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-2.2|1.1|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. The final sample size provided \>90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).||1.1|-2.2|
74019887|NCT05900115|147591920|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.68|TWO_SIDED||||||Regression, Linear|||||||0.68
73836101|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|108.0|||||TWO_SIDED|90.0|98.82|118.02|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||118.02|98.82|
73836102|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|103.34|||||TWO_SIDED|90.0|94.56|112.94|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.94|94.56|
73836103|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|105.44|||||TWO_SIDED|90.0|96.48|115.23|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||115.23|96.48|
73836104|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan Ration X 100|98.16|||||TWO_SIDED|90.0|89.82|107.28|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.28|89.82|
73836105|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Panacea Ratio X 100|93.93|||||TWO_SIDED|90.0|85.96|102.65|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||102.65|85.96|
73836106|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|95.84|||||TWO_SIDED|90.0|87.69|104.74|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.74|87.69|
73836107|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|95.69|||||TWO_SIDED|90.0|87.56|104.58|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.58|87.56|
73836108|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|97.63|||||TWO_SIDED|90.0|89.34|107.71|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.71|89.34|
73836109|NCT02014103|147221288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Pancea/Sandoz Ratio X 100|102.03|||||TWO_SIDED|90.0|93.36|111.51|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||111.51|93.36|
74080420|NCT03428750|147713415|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
74080421|NCT03428750|147713416|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73836110|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|141.91|||||TWO_SIDED|90.0|125.73|160.16|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||160.16|125.73|
73836111|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|104.13|||||TWO_SIDED|90.0|92.33|117.45|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||117.45|92.33|
73836112|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|116.02|||||TWO_SIDED|90.0|102.87|130.87|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||130.87|102.87|
73836113|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|108.92|||||TWO_SIDED|90.0|96.51|122.94|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||122.94|96.51|
73836114|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|94.06|||||TWO_SIDED|90.0|83.33|106.16|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||106.16|83.33|
73836115|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr. Reddys Ratio X 100|136.27|||||TWO_SIDED|90.0|120.82|153.7|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||153.70|120.82|
73958511|NCT03224299|147452209|SUPERIORITY||Mean Difference (Final Values)|1.93|||||TWO_SIDED|95.0|1.36|2.49||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.49|1.36|
74019888|NCT05900115|147591921|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.32|STANDARD_ERROR_OF_MEAN|0.13||0.01|TWO_SIDED||||||Regression, Linear|||||||0.01
73836116|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|122.31|||||TWO_SIDED|90.0|108.37|138.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||138.04|108.37|
73836117|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|130.28|||||TWO_SIDED|90.0|115.43|147.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||147.04|115.43|
73836118|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|150.88|||||TWO_SIDED|90.0|133.77|170.18|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||170.18|133.77|
73836119|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Mylan Ratio X 100|89.75|||||TWO_SIDED|90.0|79.52|101.3|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||101.30|79.52|
73836120|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Panacea Ratio X 100|95.6|||||TWO_SIDED|90.0|84.71|107.9|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||107.90|84.71|
73836121|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|110.72|||||TWO_SIDED|90.0|98.1|124.96|||||Bioequivalence is established when 90% confidence interval falls within 80-125|||124.96|98.10|
73836122|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|106.52|||||TWO_SIDED|90.0|94.44|120.15|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||120.15|94.44|
74019889|NCT05900115|147591922|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.18|TWO_SIDED||||||Regression, Linear|||||||0.18
73836123|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|123.36|||||TWO_SIDED|90.0|109.3|139.23|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||139.23|109.30|
73836124|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|115.81|||||TWO_SIDED|90.0|102.68|130.62|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||130.62|102.68|
73836125|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|112.96|||||TWO_SIDED|90.0|100.32|127.2|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||127.20|100.32|
74080422|NCT03428750|147713417|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73897338|NCT04740905|147327935|SUPERIORITY||Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.84||0.4978|TWO_SIDED|95.0|-2.2|1.1||Tested at a two-sided 0.0497 significance level.|Mixed Model of Repeated Measures||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The final sample size provided \>80% power for a 3.5-letter superiority assessment of faricimab over aflibercept.||1.1|-2.2|0.4978
73958512|NCT03224299|147452209|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.73|0.36||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.36|-0.73|
73836126|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|101.75|||||TWO_SIDED|90.0|90.37|114.57|||||Bioequivalence is established when 90% confidence interval falls within 80-125|||114.57|90.37|
73897339|NCT04740905|147327937|OTHER||Difference in CMH Weighted Percentage|-4.3|||||TWO_SIDED|95.0|-12.3|3.8||||||||3.8|-12.3|
73897340|NCT04740905|147327953|OTHER||Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.9|1.1||||||||1.1|-1.9|
73897341|NCT02700334|147328003|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73897342|NCT02700334|147328004|OTHER|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
73897343|NCT02700334|147328005|OTHER|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
73897344|NCT02700334|147328006|OTHER|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||||||0.959
73897345|NCT02700334|147328007|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73897346|NCT02700334|147328008|OTHER|||||||0.331|||||||Wilcoxon (Mann-Whitney)|||||||0.331
73897347|NCT02700334|147328009|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73897348|NCT02700334|147328010|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73958513|NCT03224299|147452209|SUPERIORITY||Mean Difference (Final Values)|2.23|||||TWO_SIDED|95.0|1.69|2.78||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.78|1.69|
73958514|NCT03224299|147452209|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.9|0.31||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.31|-0.90|
73897349|NCT02700334|147328011|OTHER|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||||||0.575
73897350|NCT02700334|147328012|OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
73897351|NCT02700334|147328013|OTHER|||||||0.721|||||||Wilcoxon (Mann-Whitney)|||||||0.721
73836127|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astella Ratio X 100|113.52|||||TWO_SIDED|90.0|100.82|127.83|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||127.83|100.82|
73897352|NCT02700334|147328014|OTHER|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
73897353|NCT02700334|147328015|OTHER|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||||||0.333
73897354|NCT02700334|147328016|OTHER|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
73897355|NCT02700334|147328017|OTHER|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
73897356|NCT02700334|147328018|OTHER|||||||0.919|||||||Wilcoxon (Mann-Whitney)|||||||0.919
73897357|NCT02700334|147328019|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.720
73897358|NCT02412488|147328020|OTHER|"The goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision. The target sample size of approximately 200 subjects undergoing Reveal LINQ insertion was selected to ensure that the upper 95% confidence interval would be within 3 percentage points of the point estimate of the untoward event rate assuming the underlying rate was 2%"|Event Rate expressed as a percent|0.0|||||TWO_SIDED|95.0|0.0|2.1|||||The estimate is the observed rate of untoward events expressed as a percentage. The 95% confidence interval is also expressed as a percentage|"There was no formal statistical hypothesis test associated with the primary outcome measure. Rather the goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision."||2.1|0|
73897359|NCT00796991|147328021|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.963|||||TWO_SIDED|90.0|0.794|1.168|||Mixed Models Analysis|A general linear mixed model was applied to paclitaxel log(Cmax) using study day as a fixed effect.||Estimated effect of ipilimumab on paclitaxel Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1)||1.168|0.794|
73897360|NCT00796991|147328021|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.027|||||TWO_SIDED|90.0|0.848|1.243|||Mixed Models Analysis|study day was used as a fixed effect||Estimated effect of ipilimumab on dacarbazine Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.243|0.848|
73958515|NCT03224299|147452209|SUPERIORITY||Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0|1.98|3.22||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||3.22|1.98|
73897361|NCT00796991|147328021|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.058|||||TWO_SIDED|90.0|0.974|1.15|||Mixed Models Analysis|study day was used as a fixed effect||Estimated effect of ipilimumab on AIC Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.150|0.974|
73897362|NCT00796991|147328021|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.934||||||90.0|0.768|1.136|||linear model|treatment arm as a fixed effect||Estimated effect of paclitaxel/carboplatin on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.||1.136|0.768|
73897363|NCT00796991|147328021|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.982|||||TWO_SIDED|90.0|0.798|1.208|||linear model|treatment arm as a fixed effect||Estimated effect of dacarbazine on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.||1.208|0.798|
73897364|NCT00796991|147328025|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.068|||||TWO_SIDED|90.0|0.954|1.196|||Mixed Models Analysis|A general linear mixed model was applied to paclitaxel log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on paclitaxel AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1).||1.196|0.954|
73897365|NCT00796991|147328025|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.912|||||TWO_SIDED|90.0|0.757|1.099|||Mixed Models Analysis|A general linear mixed model was applied to dacarbazine log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on dacarbazine AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.099|0.757|
73897366|NCT00796991|147328025|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.891|1.056|||Mixed Models Analysis|A general linear mixed model was applied to active metabolite AIC log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on AUC(INF) for AIC. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.056|0.891|
74019890|NCT05900115|147591923|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.83|TWO_SIDED||||||Regression, Linear|||||||0.83
74019891|NCT05900115|147591924|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.56|TWO_SIDED||||||Regression, Linear|||||||0.56
73897367|NCT00796991|147328025|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.934|||||TWO_SIDED|90.0|0.768|1.136|||linear model|treatment arm as fixed effect||Estimated effect of paclitaxel/carboplatin on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.||1.136|0.768|
73897368|NCT00796991|147328025|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.982|||||TWO_SIDED|90.0|0.7981|1.208|||linear model|treatment arm as a fixed effect||Estimated effect of dacarbazine on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.||1.208|0.7981|
73897369|NCT00796991|147328031|SUPERIORITY_OR_OTHER|||||||0.027||||||p-value was not corrected for multiple testing. F-statistic = 1.86.|conditional F test|15 degrees freedom (DF) in numerator and 335 DF in denominator.||null hypothesis of no mean ALC changes over time in any treatment group. Conditional F-tests were used to test for mean ALC changes over time in each treatment arm and the difference between treatment arms in the pattern of change in ALC over time.||||0.027
73897370|NCT00796991|147328031|SUPERIORITY_OR_OTHER|||||||0.5||||||P-values were not corrected for multiple testing. F Statistic =0.94|Omnibus conditional F-test|10 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in all treatment groups. Test of overall time-by-treatment interaction used an omnibus conditional F-test.||||0.5
73897371|NCT00796991|147328031|SUPERIORITY_OR_OTHER|||||||0.37||||||P-values were not corrected for multiple testing. F Statistic =1.08|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.37
74019892|NCT05900115|147591925|EQUIVALENCE|To examine intervention effects on primary dichotomous outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Odds Ratio (OR)|1.11|STANDARD_ERROR_OF_MEAN|0.54||0.85|TWO_SIDED|95.0|0.38|3.2|||Regression, Logistic|||||3.20|.38|0.85
74019893|NCT05900115|147591926|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.0|STANDARD_ERROR_OF_MEAN|0.05||1|TWO_SIDED||||||Regression, Linear|||||||1.00
73836128|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|99.16|||||TWO_SIDED|90.0|88.06|111.64|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||111.64|88.06|
73836129|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|95.57|||||TWO_SIDED|90.0|84.89|107.61|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||107.61|84.89|
73836130|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddy Ratio X 100|111.01|||||TWO_SIDED|90.0|98.59|125.0|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||125.00|98.59|
73836131|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|99.51|||||TWO_SIDED|90.0|88.38|112.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||112.04|88.38|
73836132|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|113.93|||||TWO_SIDED|90.0|101.18|128.28|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||128.28|101.18|
73836133|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|118.19|||||TWO_SIDED|90.0|104.96|133.08|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||133.08|104.96|
73836134|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan|89.64|||||TWO_SIDED|90.0|79.61|100.93|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||100.93|79.61|
73836135|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Panacea Ratio X 100|102.63|||||TWO_SIDED|90.0|91.15|115.55|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||115.55|91.15|
73836136|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Sandoz Ratio X 100|106.46|||||TWO_SIDED|90.0|94.55|119.88|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||119.88|94.55|
73836137|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|114.49|||||TWO_SIDED|90.0|110.68|128.92|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||128.92|110.68|
73897372|NCT00796991|147328031|SUPERIORITY_OR_OTHER|||||||0.85||||||P-values were not corrected for multiple testing. F Statistic =0.39|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.85
73897373|NCT00796991|147328031|SUPERIORITY_OR_OTHER|||||||0.22||||||P-values were not corrected for multiple testing. F Statistic = 1.41|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.22
73897374|NCT00029146|147328052|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.7||||0.78||95.0|-10.4|13.8|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference. The 2-sided z-statistic was compared to a standard unit normal distribution.The study was terminated early for futility after 195 of the planned 372 participants were enrolled.||13.8|-10.4|0.78
73836138|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|118.77|||||TWO_SIDED|90.0|105.48|133.74|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||133.74|105.48|
73836139|NCT02014103|147221289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|103.74|||||TWO_SIDED|90.0|92.13|116.81|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||116.81|92.13|
73836140|NCT01245751|147221322|NON_INFERIORITY_OR_EQUIVALENCE|Week 6 GMT value for Group 1 is statistically non-inferior to Group 2 for the prespecified clinically relevant 1.5-fold ratio if the lower bound of the 95% confidence interval for the GMT ratio is \>0.67|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.97|1.15||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||Week 6 analysis||1.15|0.97|<0.001
73836141|NCT01245751|147221323|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.54|||<|0.001|TWO_SIDED|95.0|1.44|1.66||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMFR, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age||A booster dose induces a statistically acceptable VZV antibody response if the lower bound of the 95% confidence interval is \>1.0.||1.66|1.44|<0.001
73836142|NCT00676052|147221357|SUPERIORITY||Mean Difference (Net)|0.067||||0.009|TWO_SIDED|95.0|0.017|0.117||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.117|0.017|0.009
73897375|NCT00029146|147328053|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|3.5||||0.59|TWO_SIDED|95.0|-9.2|16.1|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors.||16.1|-9.2|0.59
73897376|NCT00029146|147328054|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|-3.2||||0.27|TWO_SIDED|95.0|-9.0|2.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Negative indicates lower rate in non-surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||2.6|-9.0|0.27
73897377|NCT00029146|147328055|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.3||||0.5|TWO_SIDED|95.0|-2.5|5.2|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||5.2|-2.5|0.50
73897378|NCT00029146|147328056|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|4.0||||0.13|TWO_SIDED|95.0|-1.2|9.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||9.7|-1.2|0.13
73897379|NCT00029146|147328057|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|6.5||||0.33|TWO_SIDED|95.0|-6.5|19.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||19.6|-6.5|.33
73897380|NCT00029146|147328058|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|-6.6||||0.41|TWO_SIDED|95.0|-20.6|7.3|||Fisher Exact||Negative indicates lower rate in non-surgical group. In this case, lower rate is worse since Rankin 0-1 indicates a good outcome.|||7.3|-20.6|0.41
73897381|NCT00029146|147328059|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|4.4||||0.7|TWO_SIDED|95.0|-8.2|16.9|||Fisher Exact||Positive indicates lower rate in surgical group In this case, lower rate is worse since Rankin 0-2 indicates a good outcome.|||16.9|-8.2|0.70
73897382|NCT00029146|147328060|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Fisher's Exact Test|||||||0.85
73958516|NCT03224299|147452209|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.61|0.57||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.57|-0.61|
74019894|NCT04187092|147591936|SUPERIORITY||||||<|0.05|||||||ANCOVA|||The 12-week changes in the KOOS scores, and the 12-week changes in the IKDC scores were analyzed by way of analysis of covariance (ANCOVA). Covariates: Age and sex of the subject, the subject's baseline outcome measure, the subject's baseline IKDC Total score, and the subject's standardized intake date (i.e., i.e., subject's intake date minus the intake date of the first enrolled subject) served as the ANCOVA concomitant adjustment variables||||<0.05
73958517|NCT03224299|147452209|SUPERIORITY||Mean Difference (Final Values)|2.33|||||TWO_SIDED|95.0|1.72|2.93||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.93|1.72|
73958518|NCT03224299|147452209|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.91|0.22||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.22|-0.91|
74019895|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|0.993||||0.791|TWO_SIDED|95.0|0.946|1.043|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 0 hr.|||1.043|0.946|0.791
73897383|NCT00029146|147328061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.13|TWO_SIDED|95.0|-0.54|0.07|||t-test, 2 sided||Negative indicates lower score in non-surgical group.A higher score indicates better quality of life|||0.07|-0.54|0.13
73897384|NCT00029146|147328062|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.5||||0.81|TWO_SIDED|95.0|-10.7|13.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.||Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||13.7|-10.7|0.81
73958519|NCT03224299|147452209|SUPERIORITY||Mean Difference (Final Values)|2.45|||||TWO_SIDED|95.0|1.88|3.01||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||3.01|1.88|
74019896|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr.|||1.050|0.952|>0.999
74019897|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|1.001||||0.975|TWO_SIDED|95.0|0.953|1.051|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 15 min.|||1.051|0.953|0.975
73958520|NCT03224299|147452209|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-0.85|0.24||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.24|-0.85|
73958521|NCT03224299|147452209|SUPERIORITY||Mean Difference (Final Values)|2.41|||||TWO_SIDED|95.0|1.87|2.95||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.95|1.87|
73958522|NCT03224299|147452209|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.67|0.4||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.40|-0.67|
73958523|NCT03224299|147452209|SUPERIORITY||Mean Difference (Final Values)|2.25|||||TWO_SIDED|95.0|1.7|2.8||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.80|1.70|
73836143|NCT00676052|147221357|SUPERIORITY||Mean Difference (Net)|0.097|||<|0.001|TWO_SIDED|95.0|0.047|0.147||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.147|0.047|<0.001
73836144|NCT00676052|147221357|SUPERIORITY||Mean Difference (Net)|0.069||||0.007|TWO_SIDED|95.0|0.019|0.118||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.118|0.019|0.007
73836145|NCT00676052|147221357|SUPERIORITY||Mean Difference (Net)|0.082||||0.001|TWO_SIDED|95.0|0.032|0.132||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.132|0.032|0.001
73836146|NCT00676052|147221357|SUPERIORITY||Mean Difference (Net)|0.137|||<|0.001|TWO_SIDED|95.0|0.086|0.187||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.187|0.086|<0.001
73836147|NCT00676052|147221358|SUPERIORITY||Mean Difference (Net)|0.106|||<|0.001|TWO_SIDED|95.0|0.065|0.146||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.146|0.065|<0.001
73836148|NCT00676052|147221358|SUPERIORITY||Mean Difference (Net)|0.107|||<|0.001|TWO_SIDED|95.0|0.067|0.147||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.147|0.067|<0.001
73836149|NCT00676052|147221358|SUPERIORITY||Mean Difference (Net)|0.123|||<|0.001|TWO_SIDED|95.0|0.083|0.163||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1||0.163|0.083|<0.001
73836150|NCT00676052|147221358|SUPERIORITY||Mean Difference (Net)|0.152|||<|0.001|TWO_SIDED|95.0|0.112|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.193|0.112|<0.001
73836151|NCT00676052|147221358|SUPERIORITY||Mean Difference (Net)|0.176|||<|0.001|TWO_SIDED|95.0|0.135|0.216||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1||0.216|0.135|<0.001
73836152|NCT00676052|147221358|SUPERIORITY||Mean Difference (Net)|0.106|||<|0.001|TWO_SIDED|95.0|0.056|0.157||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28||0.157|0.056|<0.001
73836153|NCT00676052|147221358|SUPERIORITY||Mean Difference (Net)|0.142|||<|0.001|TWO_SIDED|95.0|0.092|0.192||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV, Day 28||0.192|0.092|<0.001
73836154|NCT00676052|147221358|SUPERIORITY||Mean Difference (Net)|0.124|||<|0.001|TWO_SIDED|95.0|0.074|0.174||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28||0.174|0.074|<0.001
73836155|NCT00676052|147221358|SUPERIORITY||Mean Difference (Net)|0.142|||<|0.001|TWO_SIDED|95.0|0.092|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28||0.193|0.092|<0.001
73836156|NCT00676052|147221358|SUPERIORITY||Mean Difference (Net)|0.17|||<|0.001|TWO_SIDED|95.0|0.12|0.22||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28||0.220|0.120|<0.001
73897385|NCT03567343|147328077|EQUIVALENCE|Significance set to 0.05|Mean Difference (Net)|-2.1||||0.1543|TWO_SIDED|95.0|-5.03|0.82||The threshold for statistical significance was P\< 0.05.|Paired T-test|||||0.82|-5.03|0.1543
74019898|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 45 min.|||1.050|0.952|>0.999
73897386|NCT03567343|147328077|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-2.53||||0.1827|TWO_SIDED|95.0|-6.3|1.24|||Paired T-test|||||1.24|-6.3|0.1827
73897387|NCT03567343|147328078|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.2||||0.8165|TWO_SIDED|95.0|-1.96|1.56|||Paired T-test|||||1.56|-1.96|0.8165
73897388|NCT03567343|147328078|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.58||||0.1821|TWO_SIDED|95.0|-0.77|3.94|||Paired T-test|||||3.94|-0.77|0.1821
73897389|NCT03567343|147328079|EQUIVALENCE|P\<0.05|Mean Difference (Net)|20.94||||0.0156|TWO_SIDED|95.0|4.19|37.69|||Paired T-test|||||37.69|4.19|0.0156
73897390|NCT03567343|147328079|EQUIVALENCE|P\<0.05|Mean Difference (Net)|20.08||||0.0572|TWO_SIDED|95.0|-0.64|40.8|||Paired T-test|||||40.8|-0.64|0.0572
73897391|NCT03567343|147328080|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-4.48||||0.0781|TWO_SIDED|95.0|-9.37|0.41|||Paired T-test|||||0.41|-9.37|0.0781
73958524|NCT03224299|147452209|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.56|0.48||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.48|-0.56|
73958525|NCT03224299|147452209|SUPERIORITY||Mean Difference (Final Values)|2.15|||||TWO_SIDED|95.0|1.62|2.68||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.68|1.62|
73897392|NCT03567343|147328080|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-3.0||||0.242|TWO_SIDED|95.0|-8.1|2.1|||Paired T-test|||||2.1|-8.1|0.242
73897393|NCT03567343|147328081|EQUIVALENCE|P\<0.05|Mean Difference (Net)|2.91||||0.0195|TWO_SIDED|95.0|0.49|5.32|||Paired T-test|||||5.32|0.49|0.0195
73897394|NCT03567343|147328081|EQUIVALENCE|P\<0.05|Mean Difference (Net)|4.66||||0.0097|TWO_SIDED|95.0|1.19|8.12|||Paired T-test|||||8.12|1.19|0.0097
73897395|NCT03567343|147328082|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.93|||<|0.0001|TWO_SIDED|95.0|0.59|1.28|||Paired T-test|||||1.28|0.59|<0.0001
73897396|NCT03567343|147328082|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.45||||0.0179|TWO_SIDED|95.0|0.08|0.81|||Paired T-test|||||0.81|0.08|0.0179
73897397|NCT03567343|147328083|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.03||||0.9875|TWO_SIDED|95.0|-3.89|3.83|||Paired T-test|||||3.83|-3.89|0.9875
73897398|NCT03567343|147328083|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.2||||0.9463|TWO_SIDED|95.0|-6.23|5.82|||Paired T-test|||||5.82|-6.23|0.9463
73897399|NCT03567343|147328084|EQUIVALENCE|P\<0.05|Mean Difference (Net)|28.5||||0.0037|TWO_SIDED|95.0|9.84|47.17|||Paired T-test|||||47.17|9.84|0.0037
73897400|NCT03567343|147328084|EQUIVALENCE|p\<0.05|Mean Difference (Net)|9.84||||0.4395|TWO_SIDED|95.0|-15.63|35.31|||Paired T-test|||||35.31|-15.63|0.4395
73897401|NCT03567343|147328085|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.03||||0.912|TWO_SIDED|95.0|-0.59|0.53|||Paired T-test|||||0.53|-0.59|0.912
74019899|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|1.003||||0.908|TWO_SIDED|95.0|0.955|1.053|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr.|||1.053|0.955|0.908
73897402|NCT03567343|147328085|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.11||||0.8207|TWO_SIDED|95.0|-1.04|0.83|||Paired T-test|||||0.83|-1.04|.8207
73897403|NCT03567343|147328086|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.89||||0.1929|TWO_SIDED|95.0|-2.26|0.47|||Paired T-test|||||0.47|-2.26|0.1929
73897404|NCT03567343|147328086|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.24||||0.8744|TWO_SIDED|95.0|-3.35|2.86|||Paired T-test|||||2.86|-3.35|0.8744
73897405|NCT03567343|147328087|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.95||||0.2048|TWO_SIDED|95.0|-2.45|0.54|||Paired T-test|||||0.54|-2.45|0.2048
73897406|NCT03567343|147328087|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.96||||0.1933|TWO_SIDED|95.0|-0.5|2.42|||Paired T-test|||||2.42|-0.5|0.1933
73897407|NCT03567343|147328088|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-1.69||||0.034|TWO_SIDED|95.0|-3.25|-0.13|||Paired T-test|||change in mean number of lapses||-0.13|-3.25|0.034
73897408|NCT03567343|147328088|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.41||||0.5242|TWO_SIDED|95.0|-0.88|1.71|||Paired T-test|||Change in number of lapses||1.71|-0.88|0.5242
73897409|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.67||||0.8106|TWO_SIDED|95.0|-4.92|6.25|||Paired T-test|||POMS-TMD||6.25|-4.92|0.8106
73897410|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|3.87||||0.1427|TWO_SIDED|95.0|-1.35|9.09|||Paired T-test|||POMS-TMD||9.09|-1.35|0.1427
73897411|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.05||||0.9344|TWO_SIDED|95.0|-1.11|1.21|||Paired T-test|||POMS-Tension||1.21|-1.11|0.9344
73897412|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.54||||0.0092|TWO_SIDED|95.0|0.4|2.69|||Paired T-test|||POMS-Tension||2.69|0.40|0.0092
73897413|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.29||||0.755|TWO_SIDED|95.0|-1.55|2.12|||Paired T-test|||POMS-Depression||2.12|-1.55|0.755
73897414|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.74||||0.2131|TWO_SIDED|95.0|-0.44|1.92|||Paired T-test|||POMS-Depression||1.92|-0.44|0.2131
73897415|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.19||||0.06|TWO_SIDED|95.0|-0.05|2.43|||Paired T-test|||POMS-Anger||2.43|-0.05|0.06
73897416|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.24||||0.4117|TWO_SIDED|95.0|-0.34|0.82|||Paired T-test|||POMS-Anger||0.82|-0.34|0.4117
73897417|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.05||||0.9548|TWO_SIDED|95.0|-1.64|1.73|||Paired T-test|||POMS-Fatigue||1.73|-1.64|0.9548
73897418|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.48||||0.4649|TWO_SIDED|95.0|-0.83|1.79|||Paired T-test|||POMS-Fatigue||1.79|-0.83|0.4649
73897419|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.26||||0.5656|TWO_SIDED|95.0|-0.65|1.18|||Paired T-test|||POMS-Confusion||1.18|-0.65|0.5656
73897420|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.33||||0.4307|TWO_SIDED|95.0|-0.5|1.15|||Paired T-test|||POMS-Confusion||1.15|-0.5|0.4307
73958526|NCT00959920|147452216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.8||||0.42|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that patients for whom indwelling foley catheterization was employed will have their time to delivery interval reduced by 30 minutes.||||.42
73897421|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.17||||0.2651|TWO_SIDED|95.0|-0.92|3.25|||Paired T-test|||POMS-Vigor||3.25|-0.92|0.2651
73897422|NCT03567343|147328089|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.54||||0.5992|TWO_SIDED|95.0|-2.61|1.53|||Paired T-test|||POMS-Vigor||1.53|-2.61|0.5992
73897423|NCT03567343|147328090|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.37||||0.6869|TWO_SIDED|95.0|-1.48|2.22|||Paired T-test|||||2.22|-1.48|0.6869
73897424|NCT03567343|147328090|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.39||||0.1769|TWO_SIDED|95.0|-0.65|3.43|||Paired T-test|||||3.43|-0.65|0.1769
73897425|NCT03567343|147328091|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.51||||0.6422|TWO_SIDED|95.0|-1.69|2.72|||Paired T-test|||||2.72|-1.69|0.6422
73897426|NCT03567343|147328091|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.63||||0.4106|TWO_SIDED|95.0|-0.9|2.16|||Paired T-test|||||2.16|-0.9|0.4106
73897427|NCT03567343|147328092|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.23||||0.5672|TWO_SIDED|95.0|-1.05|0.58|||Paired T-test|||||0.58|-1.05|0.5672
74019900|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|1.025||||0.312|TWO_SIDED|95.0|0.977|1.077|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr 45 min.|||1.077|0.977|0.312
73897428|NCT03567343|147328092|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.11||||0.805|TWO_SIDED|95.0|-0.77|0.99|||Paired T-test|||||0.99|-0.77|0.805
73897429|NCT03567343|147328093|EQUIVALENCE|P\<0.05|Median Difference (Net)|-43.09||||0.1236|TWO_SIDED|95.0|-98.43|12.26|||Paired T-test|||Change in lapse time||12.26|-98.43|.1236
73897430|NCT03567343|147328093|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-2.01||||0.8241|TWO_SIDED|95.0|-20.13|16.11|||Paired T-test|||Change in lapse time||16.11|-20.13|.8241
73897431|NCT00392379|147328096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|STANDARD_DEVIATION|43.0|<|0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons.|Regression, Logistic|||Based upon previous research, we hypothesized that the end-of-treatment abstinence rate for subjects receiving placebo would be 35% and the abstinence rate for subjects receiving the 4-mg nicotine lozenge would be 53%. A resulting power calculation indicated that 270 subjects (135 per group) were required in order to have 85% power to detect a significant difference (two-sided, α = 0.05 level test).||||<0.05
73897432|NCT02365233|147328102|SUPERIORITY||||||||||||||||||IRB withheld the data due to inadequate supporting documentation|||
73897433|NCT00827931|147328103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-99.9|STANDARD_ERROR_OF_MEAN|131.99||0.46|TWO_SIDED|95.0|-371.4|171.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||171.5|-371.4|0.460
73897434|NCT00827931|147328104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.6|STANDARD_ERROR_OF_MEAN|147.61||0.579|TWO_SIDED|95.0|-386.5|219.3|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||219.3|-386.5|0.579
73897435|NCT00827931|147328105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.5|STANDARD_ERROR_OF_MEAN|239.19||0.452|TWO_SIDED|95.0|-672.6|305.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||305.5|-672.6|0.452
73897436|NCT00827931|147328106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-417.7|STANDARD_ERROR_OF_MEAN|152.51||0.01|TWO_SIDED|95.0|-729.4|-106.1|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||-106.1|-729.4|0.010
73897437|NCT00827931|147328107|SUPERIORITY_OR_OTHER|||||||0.701|TWO_SIDED||||||Fisher Exact|||Fisher's exact test was used at 5% level of significance.||||0.701
73897438|NCT00608569|147328119|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Results were considered to be statistically significant if p\<0.05|Fisher Exact|||Fisher exact test (unstratified)||||0.133
73897439|NCT03011892|147328127|SUPERIORITY||Difference in Least Square (LS) Mean|-59.66|||<|0.0001|TWO_SIDED|95.0|-77.85|-41.47|||MMRM|||||-41.47|-77.85|< 0.0001
74019901|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|1.008||||0.763|TWO_SIDED|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr.|||1.058|0.960|0.763
73897440|NCT03011892|147328128|SUPERIORITY||Difference in LS Mean|-33.01||||0.0004|TWO_SIDED|95.0|-51.27|-14.76|||MMRM|||DB: Vehicle BID, Ruxolitinib 0.15% QD||-14.76|-51.27|0.0004
73897441|NCT03011892|147328128|SUPERIORITY||Difference in LS Mean|-40.9|||<|0.0001|TWO_SIDED|95.0|-59.23|-22.57|||MMRM|||||-22.57|-59.23|< 0.0001
73897442|NCT03011892|147328128|SUPERIORITY||Difference in LS Mean|-54.82|||<|0.0001|TWO_SIDED|95.0|-72.93|-36.7|||MMRM|||||-36.70|-72.93|< 0.0001
73897443|NCT03011892|147328129|SUPERIORITY||Difference in LS Mean|14.63||||0.1127|TWO_SIDED|95.0|-3.47|32.73|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.15% QD||32.73|-3.47|0.1127
74019902|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|1.095|||<|0.001|TWO_SIDED|95.0|1.043|1.15|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 30 min.|||1.150|1.043|<0.001
73897444|NCT03011892|147328129|SUPERIORITY||Difference in LS Mean|6.74||||0.4659|TWO_SIDED|95.0|-11.44|24.92|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.5% QD||24.92|-11.44|0.4659
73897445|NCT03011892|147328129|SUPERIORITY||Difference in LS Mean|-7.18||||0.432|TWO_SIDED|95.0|-25.13|10.77|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 1.5% QD||10.77|-25.13|0.4320
73897446|NCT03011892|147328129|SUPERIORITY||Difference in LS Mean|-12.02||||0.1903|TWO_SIDED|95.0|-30.05|6.0|||MMRM|||||6.00|-30.05|0.1903
73897447|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-25.12||||0.0009|TWO_SIDED|95.0|-39.84|-10.41|||MMRM|||Week 2||-10.41|-39.84|0.0009
73897448|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-47.85|||<|0.0001|TWO_SIDED|95.0|-62.64|-33.06|||MMRM|||Week 2||-33.06|-62.64|< 0.0001
73897449|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-41.04|||<|0.0001|TWO_SIDED|95.0|-56.0|-26.08|||MMRM|||Week 2||-26.08|-56.00|< 0.0001
73897450|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-45.05|||<|0.0001|TWO_SIDED|95.0|-59.69|-30.4|||MMRM|||Week 2||-30.40|-59.69|< 0.0001
74080423|NCT03428750|147713418|SUPERIORITY||||||<|0.001|||||||ANCOVA|With factors of treatment group and analysis center adjusted for baseline values in the model||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73897451|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|9.99||||0.1806|TWO_SIDED|95.0|-4.66|24.63|||MMRM|||Week 2||24.63|-4.66|0.1806
73897452|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-5.93||||0.4333|TWO_SIDED|95.0|-20.82|8.95|||MMRM|||Week 2||8.95|-20.82|0.4333
73958527|NCT03546907|147452240|SUPERIORITY||Risk Ratio (RR)|0.808||||0.1296|TWO_SIDED|95.0|0.613|1.065|||Negative binomial regression model|||Analysis was performed using negative binomial regression model with total number of events occurring during observation duration as response variable, treatment, baseline eosinophil strata, region, number of severe COPD exacerbations experienced in previous year(0 vs. 1+) at baseline, smoking history(current vs. former smoker), post-BD FEV1 percent(%) predicted (less than\[\<\] 50% vs greater than equal\[\>=\]50%) at baseline as covariates, and log-transformed observation duration as offset variable.||1.065|0.613|0.1296
73958528|NCT01616654|147452271|SUPERIORITY||Percentage difference|13.115||||0.096|TWO_SIDED|95.0|-3.266|29.495|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||29.495|-3.266|0.096
73836157|NCT00676052|147221359|SUPERIORITY||Mean Difference (Net)|0.166|||<|0.001|TWO_SIDED|95.0|0.094|0.237||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.237|0.094|<0.001
73897453|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-9.94||||0.1805|TWO_SIDED|95.0|-24.51|4.63|||MMRM|||Week 2||4.63|-24.51|0.1805
73897454|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-12.74||||0.0895|TWO_SIDED|95.0|-27.45|1.98|||MMRM|||Week 2||1.98|-27.45|0.0895
73958529|NCT01616654|147452271|SUPERIORITY||Percentage difference|16.393||||0.04|TWO_SIDED|95.0|-0.249|33.036|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction||33.036|-0.249|0.040
73958530|NCT01616654|147452271|SUPERIORITY||Percentage difference|10.273||||0.184|TWO_SIDED|95.0|-5.923|26.47|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||26.470|-5.923|0.184
73958531|NCT01616654|147452271|SUPERIORITY||Percentage difference|16.393||||0.041|TWO_SIDED|95.0|-0.249|33.036|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||33.036|-0.249|0.041
73958532|NCT01616654|147452272|SUPERIORITY||Percentage difference|-6.74||||0.108|TWO_SIDED|95.0|-14.96|1.48|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.||1.48|-14.96|0.108
74019903|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|1.046||||0.07|TWO_SIDED|95.0|0.996|1.098|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 45 min.|||1.098|0.996|0.070
74019904|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|0.971||||0.238|TWO_SIDED|95.0|0.925|1.02|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 15 min.|||1.020|0.925|0.238
74019905|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|0.975||||0.298|TWO_SIDED|95.0|0.928|1.023|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 30 min.|||1.023|0.928|0.298
74019906|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|0.994||||0.821|TWO_SIDED|95.0|0.947|1.044|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 45 min.|||1.044|0.947|0.821
73836158|NCT00676052|147221359|SUPERIORITY||Mean Difference (Net)|0.186|||<|0.001|TWO_SIDED|95.0|0.115|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.258|0.115|<0.001
73897455|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-28.38||||0.0042|TWO_SIDED|95.0|-47.74|-9.02|||MMRM|||Week 8||-9.02|-47.74|0.0042
73897456|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-36.52||||0.0003|TWO_SIDED|95.0|-56.03|-17.01|||MMRM|||Week 8||-17.01|-56.03|0.0003
73897457|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-45.19|||<|0.0001|TWO_SIDED|95.0|||||MMRM|||Week 8||||< 0.0001
73897458|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-57.15|||<|0.0001|TWO_SIDED|95.0|-76.53|-37.77|||MMRM|||Week 8||-37.77|-76.53|< 0.0001
73897459|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|7.78||||0.4243|TWO_SIDED|95.0|-11.37|26.93|||MMRM|||Week 8||26.93|-11.37|0.4243
73897460|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-0.35||||0.9715|TWO_SIDED|95.0|-19.65|18.95|||MMRM|||Week 8||18.95|-19.65|0.9715
73897461|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-9.03||||0.3507|TWO_SIDED|95.0|-28.05|9.99|||MMRM|||Week 8||9.99|-28.05|0.3507
73897462|NCT03011892|147328130|SUPERIORITY||Difference in LS Mean|-20.98||||0.032|TWO_SIDED|95.0|-40.15|-1.82|||MMRM|||Week 8||-1.82|-40.15|0.0320
73897463|NCT02282293|147328137|OTHER||Risk Ratio (RR)|1.96||||0.5|TWO_SIDED|95.0|0.5|7.61||Calculated p-value|Chi-squared|||||7.61|0.50|0.50
73897464|NCT02282293|147328139|OTHER||Risk Ratio (RR)|1.96||||0.5|TWO_SIDED|95.0|0.5|7.61|||Chi-squared|||||7.61|0.50|0.50
73958533|NCT01616654|147452272|SUPERIORITY||Percentage difference|-7.88||||0.06|TWO_SIDED|95.0|-16.11|0.34|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.||0.34|-16.11|0.060
73958534|NCT01616654|147452272|SUPERIORITY||Percentage difference|-8.11||||0.054|TWO_SIDED|95.0|-16.35|0.13|||ANCOVA|||Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.||0.13|-16.35|0.054
73958535|NCT01616654|147452272|SUPERIORITY||Percentage difference|-12.97||||0.002|TWO_SIDED|95.0|-21.18|-4.76|||ANCOVA|||Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.||-4.76|-21.18|0.002
73958536|NCT01616654|147452273|SUPERIORITY|||||||0.067|||||||Cochran-Mantel-Haenszel|||||||0.067
73958537|NCT01616654|147452273|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|||||||0.054
73958538|NCT01616654|147452273|SUPERIORITY|||||||0.038|||||||Cochran-Mantel-Haenszel|||||||0.038
73897465|NCT02282293|147328141|OTHER||Risk Ratio (RR)|0.45||||0.19|TWO_SIDED|95.0|0.13|1.48||Calculated p-value|GEE|||||1.48|0.13|0.19
73897466|NCT02282293|147328142|OTHER||Risk Ratio (RR)|1.33||||0.35|TWO_SIDED|95.0|0.72|2.45|||Chi-squared|||||2.45|0.72|0.35
73897467|NCT02312687|147328165|SUPERIORITY||Least Squares (LS) Mean|0.68|||<|0.0001|TWO_SIDED|95.0|0.48|0.88||The generalized estimation equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|generalized estimation equation (GEE)|||Change at Week 24||0.88|0.48|< 0.0001
73897468|NCT02312687|147328165|SUPERIORITY||LS Mean|0.68|||<|0.0001|TWO_SIDED|95.0|0.57|0.79||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||0.79|0.57|< 0.0001
73897469|NCT02312687|147328165|SUPERIORITY||LS Mean|0.59|||<|0.0001|TWO_SIDED|95.0|0.44|0.75||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||0.75|0.44|< 0.0001
73897470|NCT02312687|147328165|SUPERIORITY||LS Mean|0.47|||<|0.0001|TWO_SIDED|95.0|0.31|0.63||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||0.63|0.31|< 0.0001
73897471|NCT02312687|147328165|SUPERIORITY||LS Mean|0.57|||<|0.0001|TWO_SIDED|95.0|0.41|0.73||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||0.73|0.41|< 0.0001
73897472|NCT02312687|147328165|SUPERIORITY||LS Mean|0.59|||<|0.0001|TWO_SIDED|95.0|0.43|0.76||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||0.76|0.43|< 0.0001
73897473|NCT02312687|147328166|SUPERIORITY||LS Mean|-9.75||||0.1366|TWO_SIDED|95.0|-22.59|3.09||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 24||3.09|-22.59|0.1366
73958539|NCT01616654|147452273|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
73958540|NCT02057692|147452281|SUPERIORITY||LS mean difference|-0.889|STANDARD_ERROR_OF_MEAN|0.3969||0.0321|TWO_SIDED|95.0|-1.698|0.081|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by analysis of covariance (ANCOVA) using a PROC MIXED procedure. Least-squares (LS) mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||0.081|-1.698|0.0321
73958541|NCT02057692|147452281|SUPERIORITY||LS mean difference|-0.906|STANDARD_ERROR_OF_MEAN|0.3503||0.0145|TWO_SIDED|95.0|-1.62|-0.192|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% CI for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||-0.192|-1.620|0.0145
74019907|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|0.991||||0.715|TWO_SIDED|95.0|0.944|1.04|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr.|||1.040|0.944|0.715
73897474|NCT02312687|147328166|SUPERIORITY||LS Mean|-11.17||||0.1334|TWO_SIDED|95.0|-25.76|3.42||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 48||3.42|-25.76|0.1334
73836159|NCT00676052|147221359|SUPERIORITY||Mean Difference (Net)|0.198|||<|0.001|TWO_SIDED|95.0|0.127|0.268||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.268|0.127|<0.001
73897475|NCT02312687|147328166|SUPERIORITY||LS Mean|-18.12|||<|0.0001|TWO_SIDED|95.0|-27.07|-9.17||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 72||-9.17|-27.07|< 0.0001
73897476|NCT02312687|147328166|SUPERIORITY||LS Mean|-25.28|||<|0.0001|TWO_SIDED|95.0|-36.21|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 96||-14.35|-36.21|< 0.0001
73897477|NCT02312687|147328166|SUPERIORITY||LS Mean|-22.39|||<|0.0001|TWO_SIDED|95.0|-31.51|-13.26||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 120||-13.26|-31.51|< 0.0001
73958542|NCT02057692|147452281|SUPERIORITY||LS mean difference|-0.039|STANDARD_ERROR_OF_MEAN|0.4431||0.9298|TWO_SIDED|95.0|-0.942|0.863|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||0.863|-0.942|0.9298
73958543|NCT00545844|147452287|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73958544|NCT00545844|147452288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73958545|NCT00545844|147452289|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
73958546|NCT00545844|147452290|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
74019908|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|1.008||||0.759|TWO_SIDED|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 15 min.|||1.058|0.960|0.759
73897478|NCT02312687|147328166|SUPERIORITY||LS Mean|-28.33|||<|0.0001|TWO_SIDED|95.0|-40.11|-16.56||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 144||-16.56|-40.11|< 0.0001
73897479|NCT02312687|147328167|SUPERIORITY||LS Mean|215493.38|||<|0.0001|TWO_SIDED|95.0|194650.78|236335.97||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||236335.97|194650.78|< 0.0001
73897480|NCT02312687|147328167|SUPERIORITY||LS Mean|202525.38|||<|0.0001|TWO_SIDED|95.0|168364.92|236685.83||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||236685.83|168364.92|< 0.0001
73897481|NCT02312687|147328167|SUPERIORITY||LS Mean|221481.03|||<|0.0001|TWO_SIDED|95.0|179628.07|263333.98||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||263333.98|179628.07|< 0.0001
73897482|NCT02312687|147328167|SUPERIORITY||LS Mean|221674.07|||<|0.0001|TWO_SIDED|95.0|181313.34|262034.81||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||262034.81|181313.34|< 0.0001
73897483|NCT02312687|147328167|SUPERIORITY||LS Mean|208270.02|||<|0.0001|TWO_SIDED|95.0|167217.98|249322.06||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||249322.06|167217.98|< 0.0001
73897484|NCT02312687|147328167|SUPERIORITY||LS Mean|235953.55|||<|0.0001|TWO_SIDED|95.0|166110.59|305796.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||305796.52|166110.59|< 0.0001
73897485|NCT02312687|147328168|SUPERIORITY||LS Mean|1277.84|||<|0.0001|TWO_SIDED|95.0|1202.34|1353.34||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||1353.34|1202.34|< 0.0001
73897486|NCT02312687|147328168|SUPERIORITY||LS Mean|1244.99|||<|0.0001|TWO_SIDED|95.0|1166.1|1323.88||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||1323.88|1166.10|< 0.0001
73897487|NCT02312687|147328168|SUPERIORITY||LS Mean|1298.49|||<|0.0001|TWO_SIDED|95.0|1233.56|1363.43||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||1363.43|1233.56|< 0.0001
73897488|NCT02312687|147328168|SUPERIORITY||LS Mean|1311.05|||<|0.0001|TWO_SIDED|95.0|1238.3|1383.8||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||1383.80|1238.30|< 0.0001
73897489|NCT02312687|147328168|SUPERIORITY||LS Mean|1368.68|||<|0.0001|TWO_SIDED|95.0|1327.4|1409.96||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||1409.96|1327.40|< 0.0001
73897490|NCT02312687|147328168|SUPERIORITY||LS Mean|1298.41|||<|0.0001|TWO_SIDED|95.0|1208.31|1388.51||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||1388.51|1208.31|< 0.0001
73897491|NCT02312687|147328169|SUPERIORITY||LS Mean|7.87||||0.0011|TWO_SIDED|95.0|3.16|12.58||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||12.58|3.16|0.0011
73897492|NCT02312687|147328169|SUPERIORITY||LS Mean|2.7||||0.3092|TWO_SIDED|95.0|-2.5|7.9||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||7.90|-2.50|0.3092
73897493|NCT02312687|147328169|SUPERIORITY||LS Mean|2.62||||0.2958|TWO_SIDED|95.0|-2.29|7.53||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||7.53|-2.29|0.2958
74019909|NCT01475734|147591950|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 30 min.|||1.050|0.952|>0.999
74080424|NCT03428750|147713419|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
74080425|NCT03428750|147713420|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73897494|NCT02312687|147328169|SUPERIORITY||LS Mean|0.31||||0.8796|TWO_SIDED|95.0|-3.71|4.33||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||4.33|-3.71|0.8796
73897495|NCT02312687|147328169|SUPERIORITY||LS Mean|-0.48||||0.8396|TWO_SIDED|95.0|-5.11|4.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||4.16|-5.11|0.8396
73897496|NCT02312687|147328169|SUPERIORITY||LS Mean|-3.43||||0.2284|TWO_SIDED|95.0|-9.0|2.15||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||2.15|-9.00|0.2284
73897497|NCT02312687|147328170|SUPERIORITY||LS Mean|0.57|||||TWO_SIDED|95.0|0.32|0.83||||||Change at Week 24||0.83|0.32|
73897498|NCT02312687|147328170|SUPERIORITY||LS Mean|0.47|||||TWO_SIDED|95.0|0.37|0.56||||||Change at Week 48||0.56|0.37|
73897499|NCT02312687|147328170|SUPERIORITY||LS Mean|0.42|||||TWO_SIDED|95.0|0.28|0.56||||||Change at Week 72||0.56|0.28|
73897500|NCT02312687|147328170|SUPERIORITY||LS Mean|0.44|||||TWO_SIDED|95.0|0.27|0.6||||||Change at Week 96||0.60|0.27|
73958547|NCT00545844|147452291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
73836160|NCT00676052|147221359|SUPERIORITY||Mean Difference (Net)|0.244|||<|0.001|TWO_SIDED|95.0|0.172|0.315||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.315|0.172|<0.001
73897501|NCT02312687|147328170|SUPERIORITY||LS Mean|0.36|||||TWO_SIDED|95.0|0.23|0.48||||||Change at Week 120||0.48|0.23|
73897502|NCT02312687|147328170|SUPERIORITY||LS Mean|0.47|||||TWO_SIDED|95.0|0.32|0.62||||||Change at Week 144||0.62|0.32|
73958548|NCT01460342|147452313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.4|-0.6|||Mixed Models Analysis|||||-0.6|-2.4|<0.001
73958549|NCT01460342|147452314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-0.5||The p-value is for the change from baseline in the IPSS Total Score at Week 4.|Mixed Models Analysis|||||-0.5|-2.0|<0.001
73958550|NCT01460342|147452314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|-2.0|-0.4||The p-value is for the change from baseline in the IPSS Total Score at Week 8.|Mixed Models Analysis|||||-0.4|-2.0|0.003
73958551|NCT01460342|147452315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.09|TWO_SIDED|95.0|-0.6|0.0||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 4.|Mixed Models Analysis|||||0.0|-0.6|0.090
73958552|NCT01460342|147452315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.8|-0.1||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 8.|Mixed Models Analysis|||||-0.1|-0.8|0.011
73958553|NCT01460342|147452315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-0.9|-0.2||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 12.|Mixed Models Analysis|||||-0.2|-0.9|0.002
73958554|NCT01460342|147452316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.5|-0.4||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 4.|Mixed Models Analysis|||||-0.4|-1.5|<0.001
73958555|NCT01460342|147452316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.3|-0.2||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 8.|Mixed Models Analysis|||||-0.2|-1.3|0.007
73958556|NCT01460342|147452316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.002|TWO_SIDED|95.0|-1.5|-0.3||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 12.|Mixed Models Analysis|||||-0.3|-1.5|0.002
73958557|NCT01460342|147452317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.277|TWO_SIDED|95.0|-0.2|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 4.|Mixed Models Analysis|||||0.1|-0.2|0.277
73958558|NCT01460342|147452317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.17|TWO_SIDED|95.0|-0.3|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 8.|Mixed Models Analysis|||||0.1|-0.3|0.170
73958559|NCT01460342|147452317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.038|TWO_SIDED|95.0|-0.4|0.0||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 12.|Mixed Models Analysis|||||-0.0|-0.4|0.038
73958560|NCT01460342|147452318|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel|||||||<0.001
73958561|NCT01460342|147452319|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel|||||||<0.001
73958562|NCT01460342|147452320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.06|TWO_SIDED|95.0|-1.2|0.0|||ANCOVA|||||0.0|-1.2|0.060
73958563|NCT01689519|147452321|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0001|TWO_SIDED|95.0|0.39|0.68||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Primary Analysis 9 May 2014||0.68|0.39|0.0001
73958564|NCT01689519|147452321|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.72||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Post hoc Efficacy Analysis: 16 January 2015||0.72|0.46|<0.0001
73958565|NCT01689519|147452321|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.79||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Extended 5-Year Analysis: 21 July 2019||0.79|0.53|<0.0001
73958566|NCT01689519|147452322|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.645||||0.0463|TWO_SIDED|95.0|0.42|1.0||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Primary Analysis 9 May 2014||1.00|0.42|0.0463
73897503|NCT02312687|147328171|SUPERIORITY||LS Mean|0.04|||||TWO_SIDED|95.0|0.01|0.07||||||Change at Week 24||0.07|0.01|
73897504|NCT02312687|147328171|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Change at Week 48||0.03|-0.01|
73897505|NCT02312687|147328171|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04||||||Change at Week 72||0.04|-0.01|
73897506|NCT02312687|147328171|SUPERIORITY||LS Mean|0.05|||||TWO_SIDED|95.0|0.02|0.07||||||Change at Week 96||0.07|0.02|
73897507|NCT02312687|147328171|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.02|0.03||||||Change at Week 120||0.03|-0.02|
73897508|NCT02312687|147328171|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|95.0|-0.01|0.05||||||Change at Week 144||0.05|-0.01|
73897509|NCT02312687|147328172|SUPERIORITY||LS Mean|-0.04|||||TWO_SIDED|95.0|-0.07|-0.01||||||Change at Week 24||-0.01|-0.07|
73958567|NCT01689519|147452322|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65||||0.0034|TWO_SIDED|95.0|0.49|0.87||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Post hoc Analysis 16 January 2015||0.87|0.49|0.0034
73958568|NCT01689519|147452322|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.005|TWO_SIDED|95.0|0.55|0.9||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Final Analysis 28 August 2015||0.90|0.55|0.0050
73958569|NCT01689519|147452323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.85|||<|0.0001|TWO_SIDED|95.0|14.13|31.58|||Chi-squared|||Primary Analysis: 9 May 2014||31.58|14.13|<0.0001
74019910|NCT00925600|147591971|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper bound of the 97.5% one-sided confidence interval, or equivalently upper bound of two-sided 95% confidence interval was less than the pre-specified non-inferiority bound of 10%.|Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|3.4||0.0026|TWO_SIDED|95.0|-6.3|7.2|||Mantel Haenszel|||The primary endpoint was summarized with the point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||7.2|-6.3|0.0026
74019911|NCT00925600|147591972|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-6.4|2.0||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||2.0|-6.4|
74019912|NCT00925600|147591973|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.9|5.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||5.3|-5.9|
73958570|NCT01689519|147452323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.6|||<|0.0001|TWO_SIDED|95.0|11.0|28.3|||Chi-squared|||Post hoc Efficacy Analysis: 16 January 2015||28.3|11.0|<0.0001
73958571|NCT01689519|147452323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.0|||<|0.0001|TWO_SIDED|95.0|11.4|28.7|||Chi-squared|||Extended 5-Year Analysis: 21 July 2019||28.70|11.40|<0.0001
73897510|NCT02312687|147328172|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.03|0.01||||||Change at Week 48||0.01|-0.03|
73897511|NCT02312687|147328172|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.04|0.01||||||Change at Week 72||0.01|-0.04|
73897512|NCT02312687|147328172|SUPERIORITY||LS Mean|-0.05|||||TWO_SIDED|95.0|-0.07|-0.02||||||Change at Week 96||-0.02|-0.07|
73897513|NCT02312687|147328172|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.03|0.02||||||Change at Week 120||0.02|-0.03|
74019913|NCT00925600|147591974|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-7.6|3.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||3.3|-7.6|
73836161|NCT00676052|147221359|SUPERIORITY||Mean Difference (Net)|0.301|||<|0.001|TWO_SIDED|95.0|0.229|0.372||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.372|0.229|<0.001
73897514|NCT02312687|147328172|SUPERIORITY||LS Mean|-0.02|||||TWO_SIDED|95.0|-0.05|0.01||||||Change at Week 144||0.01|-0.05|
73897515|NCT02312687|147328173|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.1|0.08||||||Change at Week 24||0.08|-0.10|
73897516|NCT02312687|147328173|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|95.0|-0.07|0.1||||||Change at Week 48||0.10|-0.07|
73958572|NCT03525119|147452337|NON_INFERIORITY|As per predefined criteria in protocol the non-inferiority was established only between group 1 and group 3. Non-inferiority of HAV+TDV to HAV was established if the upper bound of the 95% CI was less than 10%.|Seroprotection Rate Difference|-1.68|||||TWO_SIDED|95.0|-8.91|4.28||||||||4.28|-8.91|
74019914|NCT01734655|147592031|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
74019915|NCT01734655|147592032|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
74080426|NCT04547192|147713426|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|1.54||||0.504|TWO_SIDED|||||Adjusted for TIF introduction and time periods as fixed effects and hospitals and time periods as random effects.|generalized linear mixed regression mode|||For mobility on EU arrival assessed,||||0.504
73897517|NCT02312687|147328173|SUPERIORITY||LS Mean|0.08|||||TWO_SIDED|95.0|-0.01|0.16||||||Change at Week 72||0.16|-0.01|
73897518|NCT02312687|147328173|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.09|0.06||||||Change at Week 96||0.06|-0.09|
73897519|NCT02312687|147328173|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.12|0.1||||||Change at Week 120||0.10|-0.12|
73897520|NCT02312687|147328173|SUPERIORITY||LS Mean|-0.05|||||TWO_SIDED|95.0|-0.16|0.06||||||Change at Week 144||0.06|-0.16|
73897521|NCT02312687|147328174|SUPERIORITY||LS Mean|22.89|||||TWO_SIDED|95.0|-1.81|47.6||||||Change at Week 24||47.60|-1.81|
73897522|NCT02312687|147328174|SUPERIORITY||LS Mean|15.15|||||TWO_SIDED|95.0|-2.32|32.62||||||Change at Week 48||32.62|-2.32|
73897523|NCT02312687|147328174|SUPERIORITY||LS Mean|11.1|||||TWO_SIDED|95.0|-14.33|36.53||||||Change at Week 72||36.53|-14.33|
73897524|NCT02312687|147328174|SUPERIORITY||LS Mean|-16.65|||||TWO_SIDED|95.0|-37.5|4.2||||||Change at Week 96||4.20|-37.50|
73897525|NCT02312687|147328174|SUPERIORITY||LS Mean|3.48|||||TWO_SIDED|95.0|-32.53|39.49||||||Change at Week 120||39.49|-32.53|
73897526|NCT02312687|147328174|SUPERIORITY||LS Mean|28.55|||||TWO_SIDED|95.0|-11.12|68.22||||||Change at Week 144||68.22|-11.12|
74019916|NCT01734655|147592033|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
74019917|NCT03932799|147592038|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, coronavirus disease (COVID)-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, and health care utilization during baseline period/acute phase.|Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.16|0.38||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Robust variance estimates"||0.38|0.16|<.001
74019918|NCT03932799|147592039|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, COVID-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, health care utilization during baseline period/acute phase, and time indicator for each time period (0,1,2).|Odds Ratio (OR)|0.83||||0.43|TWO_SIDED|95.0|0.53|1.31||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Generalized estimating equation|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimates"||1.31|0.53|.43
74019919|NCT03932799|147592042|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, COVID-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, health care utilization during baseline period/acute phase, and time indicator for each time period (0,1,2).|Odds Ratio (OR)|3.04||||0.002|TWO_SIDED|95.0|1.5|6.14||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Generalized estimating equation|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimates"||6.14|1.50|.002
74019920|NCT03932799|147592043|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey covariates: days from injury to baseline survey, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and physical therapy (PT) utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, quality of life.|Odds Ratio (OR)|0.97||||0.84|TWO_SIDED|95.0|0.71|1.32||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.32|0.71|.84
73897527|NCT02312687|147328175|SUPERIORITY||LS Mean|-14.77|||||TWO_SIDED|95.0|-87.62|58.08||||||Change at Week 24||58.08|-87.62|
73897528|NCT02312687|147328175|SUPERIORITY||LS Mean|-70.79|||||TWO_SIDED|95.0|-161.31|19.74||||||Change at Week 48||19.74|-161.31|
73897529|NCT02312687|147328175|SUPERIORITY||LS Mean|-16.11|||||TWO_SIDED|95.0|-110.96|78.73||||||Change at Week 72||78.73|-110.96|
73897530|NCT02312687|147328175|SUPERIORITY||LS Mean|-41.74|||||TWO_SIDED|95.0|-150.61|67.13||||||Change at Week 96||67.13|-150.61|
73897531|NCT02312687|147328175|SUPERIORITY||LS Mean|-76.11|||||TWO_SIDED|95.0|-237.29|85.08||||||Change at Week 120||85.08|-237.29|
73958573|NCT00208507|147452352|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This was a non-inferiority test of the Harris Hip Score means at 24+ months with a 5 point non-inferiority margin.|Mean Difference (Final Values)|0.61||||0.001|ONE_SIDED|95.0|-1.56||||ANCOVA|Preoperative Harris Hip score was included in the ANCOVA model as the only covariate.|||||-1.56|0.001
73958574|NCT00982033|147452356|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANCOVA|||||||0.90
73836162|NCT00676052|147221359|SUPERIORITY||Mean Difference (Net)|0.178|||<|0.001|TWO_SIDED|95.0|0.098|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.258|0.098|<0.001
73897532|NCT02312687|147328175|SUPERIORITY||LS Mean|-96.06|||||TWO_SIDED|95.0|-206.59|14.46||||||Change at Week 144||14.46|-206.59|
73897533|NCT02312687|147328176|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Change at Week 24||0.03|-0.01|
73897534|NCT02312687|147328176|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04||||||Change at Week 48||0.04|-0.01|
73897535|NCT02312687|147328176|SUPERIORITY||LS Mean|0.0|||||TWO_SIDED|95.0|-0.02|0.02||||||Change at Week 72||0.02|-0.02|
73897536|NCT02312687|147328176|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||||||Change at Week 96||0.02|-0.04|
73897537|NCT02312687|147328176|SUPERIORITY||LS Mean|0.0|||||TWO_SIDED|95.0|-0.02|0.03||||||Change at Week 120||0.03|-0.02|
73897538|NCT02312687|147328176|SUPERIORITY||LS Mean|0.03|||||TWO_SIDED|95.0|-0.01|0.08||||||Change at Week 144||0.08|-0.01|
73897539|NCT02312687|147328177|SUPERIORITY||LS Mean|14.92||||0.0314|TWO_SIDED|95.0|1.33|28.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||28.52|1.33|0.0314
73897540|NCT02312687|147328177|SUPERIORITY||LS Mean|-1.73||||0.764|TWO_SIDED|95.0|-13.0|9.55||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||9.55|-13.00|0.7640
73958575|NCT00855465|147452400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis, due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew/died before 16 weeks were imputed with a worst value of 0m in case of death/clinical worsening without termination visit and with the last observed value otherwise. Comparison was done using analysis of covariance (ANCOVA), with baseline 6MWD as a covariate and treatment group and region as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant.||||<0.0001
73958576|NCT00855465|147452400|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|45.69|||<|0.0001|TWO_SIDED|95.0|24.74|66.63||Additional analysis, due to result of Shapiro-Wilk test.|ANCOVA|||||66.63|24.74|<0.0001
73958577|NCT00855465|147452400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
73836163|NCT00676052|147221359|SUPERIORITY||Mean Difference (Net)|0.219|||<|0.001|TWO_SIDED|95.0|0.139|0.298||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.298|0.139|<0.001
73897541|NCT02312687|147328177|SUPERIORITY||LS Mean|-22.28|||<|0.0001|TWO_SIDED|95.0|-30.2|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||-14.35|-30.20|< 0.0001
73897542|NCT02312687|147328177|SUPERIORITY||LS Mean|-20.93|||<|0.0001|TWO_SIDED|95.0|-27.92|-13.94||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||-13.94|-27.92|< 0.0001
73897543|NCT02312687|147328177|SUPERIORITY||LS Mean|-18.77||||0.0094|TWO_SIDED|95.0|-32.93|-4.6||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||-4.60|-32.93|0.0094
73836164|NCT00676052|147221359|SUPERIORITY||Mean Difference (Net)|0.191|||<|0.001|TWO_SIDED|95.0|0.111|0.27||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.270|0.111|<0.001
73836165|NCT00676052|147221359|SUPERIORITY||Mean Difference (Net)|0.232|||<|0.001|TWO_SIDED|95.0|0.152|0.312||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.312|0.152|<0.001
73836166|NCT00676052|147221359|SUPERIORITY||Mean Difference (Net)|0.294|||<|0.001|TWO_SIDED|95.0|0.214|0.373||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.373|0.214|<0.001
73836167|NCT00676052|147221360|SUPERIORITY||Mean Difference (Net)|0.099||||0.021|TWO_SIDED|95.0|0.015|0.182||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.182|0.015|0.021
73897544|NCT02312687|147328177|SUPERIORITY||LS Mean|-25.72|||<|0.0001|TWO_SIDED|95.0|-36.89|-14.54||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||-14.54|-36.89|< 0.0001
73897545|NCT02312687|147328178|SUPERIORITY||LS Mean|4.68||||0.1673|TWO_SIDED|95.0|-1.96|11.32||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||11.32|-1.96|0.1673
73897546|NCT02312687|147328178|SUPERIORITY||LS Mean|-2.68||||0.233|TWO_SIDED|95.0|-7.09|1.72||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||1.72|-7.09|0.2330
73836168|NCT00676052|147221360|SUPERIORITY||Mean Difference (Net)|0.15|||<|0.001|TWO_SIDED|95.0|0.067|0.233||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.233|0.067|<0.001
73836169|NCT00676052|147221360|SUPERIORITY||Mean Difference (Net)|0.094||||0.026|TWO_SIDED|95.0|0.011|0.177||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.177|0.011|0.026
73836170|NCT00676052|147221360|SUPERIORITY||Mean Difference (Net)|0.163|||<|0.001|TWO_SIDED|95.0|0.08|0.247||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.247|0.080|<0.001
73836171|NCT00676052|147221360|SUPERIORITY||Mean Difference (Net)|0.235|||<|0.001|TWO_SIDED|95.0|0.152|0.319||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.319|0.152|<0.001
73836172|NCT03300336|147221370|SUPERIORITY||Odds Ratio (OR)|0.77||||0.01|TWO_SIDED|95.0|0.64|0.93||a priori threshold for statistical significance p \<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline timepoints), and a site-level random effect. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.||0.93|0.64|0.01
73836173|NCT03300336|147221371|SUPERIORITY||rate ratio|1.05||||0.25|TWO_SIDED|95.0|0.97|1.15||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a log link and negative binomial distribution.|The rate ratio compares the intervention rate in the numerator vs the usual care rate in the denominator|Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline time points), a site-level random effect and random effects for each of the time periods. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.||1.15|0.97|0.25
73897547|NCT02312687|147328178|SUPERIORITY||LS Mean|-7.45|||<|0.0001|TWO_SIDED|95.0|-9.54|-5.36||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||-5.36|-9.54|< 0.0001
73897548|NCT02312687|147328178|SUPERIORITY||LS Mean|-8.08|||<|0.0001|TWO_SIDED|95.0|-9.86|-6.29||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||-6.29|-9.86|< 0.0001
73897549|NCT02312687|147328178|SUPERIORITY||LS Mean|-10.01|||<|0.0001|TWO_SIDED|95.0|-13.07|-6.95||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||-6.95|-13.07|< 0.0001
73897550|NCT02312687|147328178|SUPERIORITY||LS Mean|-10.89|||<|0.0001|TWO_SIDED|95.0|-14.77|-7.02||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||-7.02|-14.77|< 0.0001
73897551|NCT02312687|147328179|SUPERIORITY||LS Mean|343.38||||0.0113|TWO_SIDED|95.0|77.66|609.11||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||609.11|77.66|0.0113
73897552|NCT02312687|147328179|SUPERIORITY||LS Mean|41.45||||0.4972|TWO_SIDED|95.0|-78.23|161.13||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||161.13|-78.23|0.4972
73897553|NCT02312687|147328179|SUPERIORITY||LS Mean|-61.96||||0.3288|TWO_SIDED|95.0|-186.34|62.41||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||62.41|-186.34|0.3288
73897554|NCT02312687|147328179|SUPERIORITY||LS Mean|-68.62||||0.2772|TWO_SIDED|95.0|-192.39|55.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||55.16|-192.39|0.2772
73897555|NCT02312687|147328179|SUPERIORITY||LS Mean|-53.41||||0.2907|TWO_SIDED|95.0|-152.47|45.66||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||45.66|-152.47|0.2907
73897556|NCT02312687|147328179|SUPERIORITY||LS Mean|-97.46||||0.08|TWO_SIDED|95.0|-206.57|11.65||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||11.65|-206.57|0.0800
73897557|NCT02312687|147328180|SUPERIORITY||LS Mean|72.45|||<|0.0001|TWO_SIDED|95.0|39.21|105.7||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||105.70|39.21|< 0.0001
73897558|NCT02312687|147328180|SUPERIORITY||LS Mean|44.4|||<|0.0001|TWO_SIDED|95.0|30.34|58.47||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||58.47|30.34|< 0.0001
73897559|NCT02312687|147328180|SUPERIORITY||LS Mean|28.3||||0.0002|TWO_SIDED|95.0|13.24|43.37||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||43.37|13.24|0.0002
73897560|NCT02312687|147328180|SUPERIORITY||LS Mean|27.02|||<|0.0001|TWO_SIDED|95.0|13.81|40.22||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||40.22|13.81|< 0.0001
74019921|NCT03932799|147592044|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.03||||0.88|TWO_SIDED|95.0|0.71|1.49||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.49|0.71|.88
74019922|NCT03932799|147592045|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.74||||0.15|TWO_SIDED|95.0|0.49|1.11||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.11|0.49|.15
73897561|NCT02312687|147328180|SUPERIORITY||LS Mean|13.02||||0.1195|TWO_SIDED|95.0|-3.37|29.4||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||29.40|-3.37|0.1195
73897562|NCT02312687|147328180|SUPERIORITY||LS Mean|43.12||||0.2009|TWO_SIDED|95.0|-22.96|109.2||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||109.20|-22.96|0.2009
73897563|NCT00223236|147328235|SUPERIORITY_OR_OTHER|||||||0.4637|||||||Chi-squared|df=1 n=34||Null hypothsis is no group association in cocaine use.||||.4637
73897564|NCT03720652|147328239|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.18|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.18
73897565|NCT03720652|147328239|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.34|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.34
73897566|NCT03720652|147328239|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.13|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.13
73897567|NCT03720652|147328240|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.7|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.70
73897568|NCT03720652|147328240|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.66|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.66
73897569|NCT03720652|147328240|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.84|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.84
73897570|NCT03720652|147328241|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.015|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.015
74019923|NCT03932799|147592046|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.85||||0.38|TWO_SIDED|95.0|0.6|1.21||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.21|0.60|.38
74019924|NCT03932799|147592047|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.44||||0.12|TWO_SIDED|95.0|0.91|2.28||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Leisure or social activities outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.28|0.91|.12
74080427|NCT04547192|147713426|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|2.31||||0.169|TWO_SIDED||||||generalized linear mixed regression mode|||Respiratory rate at EU assessed||||0.169
73897571|NCT03720652|147328241|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.34|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.34
73897572|NCT03720652|147328241|OTHER|The statistical test is a paired test assessing change at the End-of-Program Interview relative to baseline.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.002
73897573|NCT03720652|147328242|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.022|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.022
73897574|NCT03720652|147328242|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.02|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.020
73897575|NCT03720652|147328242|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.09|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.090
73897576|NCT03720652|147328243|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.051|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.051
73897577|NCT03720652|147328243|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.044|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.044
73897578|NCT03720652|147328243|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||1|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||1.00
73897579|NCT03720652|147328244|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.023
73897580|NCT03720652|147328244|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.56|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.56
73897581|NCT03720652|147328244|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.16|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.16
73897582|NCT03720652|147328245|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.15|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.15
73897583|NCT03720652|147328245|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.12|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.12
73897584|NCT03720652|147328245|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.018|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.018
73897585|NCT03720652|147328246|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.33|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.33
73897586|NCT03720652|147328246|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.88|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.88
74080428|NCT04547192|147713426|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|25.29||||0.006|TWO_SIDED||||||generalized linear mixed regression|||Airway assessed||||0.006
73836174|NCT03300336|147221372|SUPERIORITY||Mean Difference (Net)|1.32||||0.52|TWO_SIDED|95.0|-2.7|5.33||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||5.33|-2.70|0.52
73897587|NCT03720652|147328246|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.67|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.67
73897588|NCT03720652|147328247|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
73897589|NCT03720652|147328247|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
73897590|NCT03720652|147328247|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
73897591|NCT03720652|147328248|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.17|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.17
74019925|NCT03932799|147592047|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.23||||0.42|TWO_SIDED|95.0|0.74|2.07||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Getting out with friends or family outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.07|0.74|.42
73897592|NCT03720652|147328248|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.02|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.020
73897593|NCT03720652|147328248|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.062|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.062
73897594|NCT03720652|147328249|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.013|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.013
73897595|NCT03720652|147328249|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.001
73897596|NCT03720652|147328249|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.003|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.003
73897597|NCT03720652|147328250|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.001
73897598|NCT03720652|147328250|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.01|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.010
73897599|NCT03720652|147328250|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.085|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.085
73897600|NCT03720652|147328251|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
73897601|NCT03720652|147328251|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
73897602|NCT03720652|147328251|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
73897603|NCT03720652|147328252|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.046|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.046
73897604|NCT03720652|147328252|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.14|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.14
73897605|NCT03720652|147328252|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.058|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.058
73958578|NCT00855465|147452401|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
74019926|NCT03932799|147592047|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.98||||0.91|TWO_SIDED|95.0|0.63|1.51||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Doing household chores outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.51|0.63|.91
74019927|NCT03932799|147592047|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.19||||0.59|TWO_SIDED|95.0|0.64|2.21||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Using transportation outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.21|0.64|.59
73897606|NCT03720652|147328253|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
73897607|NCT03720652|147328253|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
73897608|NCT03720652|147328253|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
73897609|NCT01588470|147328276|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73897610|NCT01588470|147328278|SUPERIORITY||Mean Difference (Final Values)|-1.1|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73958579|NCT00855465|147452401|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-246.43|||<|0.0001|TWO_SIDED|95.0|-303.33|-189.53||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-189.53|-303.33|<0.0001
73958580|NCT00855465|147452401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
73897611|NCT00678743|147328279|SUPERIORITY|All statistical significance were completed at the 5% level, two-tailed. Comparability of baseline characteristics between those who did and did not opt to enter the extension study was assessed with the chi square test and analysis of variance.||||||0.0008||||||Threshold for statistical significance p\<0.05|ANOVA|||||||0.0008
73958581|NCT00855465|147452402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
73958582|NCT00855465|147452402|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-443.99||||0.0293|TWO_SIDED|95.0|-842.95|-45.03||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-45.03|-842.95|0.0293
73958583|NCT00855465|147452402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
73958584|NCT00855465|147452403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.||||0.0026
73958585|NCT00855465|147452404|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.37||||0.1724|TWO_SIDED|95.0|-8.72|1.99||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region.|Based on Mantel-Haenszel estimate stratified by region.|"Test for difference of occurence of Any event."||1.99|-8.72|0.1724
73958586|NCT00855465|147452405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0035
73958587|NCT00855465|147452406|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||<0.0001
74019928|NCT03932799|147592048|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.24||||0.22|TWO_SIDED|95.0|0.88|1.75||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.75|0.88|.22
73897612|NCT01330017|147328283|SUPERIORITY_OR_OTHER|||||||0.4912||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.4912
73897613|NCT01330017|147328283|SUPERIORITY_OR_OTHER|||||||0.4519||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.4519
73958588|NCT00855465|147452406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13||||0.0002|TWO_SIDED|95.0|0.06|0.21||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||0.21|0.06|0.0002
73958589|NCT00855465|147452406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
73958590|NCT00855465|147452407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg Dyspnea Score, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.1220
73897614|NCT01330017|147328283|SUPERIORITY_OR_OTHER|||||||0.2186||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.2186
73958591|NCT00855465|147452407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.76||||0.0165|TWO_SIDED|95.0|-10.45|-1.06||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-1.06|-10.45|0.0165
73897615|NCT01330017|147328283|SUPERIORITY_OR_OTHER|||||||0.5983||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.5983
73958592|NCT00855465|147452407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
73958593|NCT00855465|147452409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.||||<0.0001
73958594|NCT00855465|147452409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.96|||<|0.0001|TWO_SIDED|95.0|-6.75|-3.16||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-3.16|-6.75|<0.0001
73958595|NCT00855465|147452409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0231|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0231
73958596|NCT00855465|147452410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.62||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|ANCOVA|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.||0.62|0.33|<0.0001
73958597|NCT00855465|147452410|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Additional analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73958598|NCT00855465|147452410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.1160
73958599|NCT04365400|147452442|SUPERIORITY||Hodges Lehmann Median|8.24||||0.1148124|TWO_SIDED|95.0|-2.01|18.19|||Wilcoxon (Mann-Whitney)|||||18.19|-2.01|0.1148124
73958600|NCT04365400|147452442|SUPERIORITY||Hodges Lehmann Median|-0.82||||0.8668467|TWO_SIDED|95.0|-10.16|7.96|||Wilcoxon (Mann-Whitney)|||||7.96|-10.16|0.8668467
74019929|NCT03932799|147592049|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.97||||0.02|TWO_SIDED|95.0|1.12|3.47||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||3.47|1.12|.02
74019930|NCT03932799|147592050|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.32||||0.1|TWO_SIDED|95.0|0.95|1.83||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.83|0.95|.10
74019931|NCT03932799|147592052|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|-0.01||||0.53|TWO_SIDED|95.0|-0.03|0.01||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.01|-0.03|.53
74080429|NCT04547192|147713426|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|38.38||||0.001|TWO_SIDED||||||generalized linear mixed regression|||Chest examined||||0.001
73958601|NCT04365400|147452443|SUPERIORITY||Difference in Change in HbA1c (%)|0.02516||||0.8658|TWO_SIDED|95.0|-0.26658|0.316897|||ANCOVA|||||0.316897|-0.26658|0.8658
73958602|NCT04365400|147452443|SUPERIORITY||Difference in Change in HbA1c (%)|-0.07333||||0.65|TWO_SIDED|95.0|-0.39012|0.243455|||ANCOVA|||||0.243455|-0.39012|0.6500
73958603|NCT04567888|147452458|SUPERIORITY||Slope|-1.41|||<|0.001|TWO_SIDED|95.0|-1.88|-0.95||Threshold for statistical significance set to .050.|Repeated-measures Multilevel Models|||||-0.95|-1.88|<.001
73958604|NCT04567888|147452459|SUPERIORITY||Slope|-0.54|||<|0.001|TWO_SIDED|95.0|-0.78|-0.3||Threshold for statistical significance was set to .050.|Repeated-measures Multilevel Models|||||-0.30|-0.78|< .001
73958605|NCT01490580|147452480|SUPERIORITY||Risk Difference (RD)|-6.4||||0.38|TWO_SIDED|95.0|-21.0|8.1|||Mixed Models Analysis|||||8.1|-21.0|0.38
74080430|NCT04547192|147713426|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|93.01||||0.001|TWO_SIDED||||||generalized linear mixed regression|||For Intra-abdominal bleeding evaluated||||0.001
73958606|NCT00371566|147452489|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|1.93||0.394||95.0|-5.5|2.19|||ANCOVA|Null hypothesis or reject it in favor of the two sided alternative hypothesis||The study was designed to provide evidence to support the null hypothesis: Delta equals 0% or reject it in favor of the two sided alternative hypothesis: Delta does not equal 0%, where Delta was the difference in the true response rate for the two treatment groups.||2.19|-5.50|.394
73958607|NCT00972504|147452522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.2|-0.1||||||||-0.1|-1.2|
73958608|NCT00972504|147452522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.8|-0.8||||||||-0.8|-1.8|
73958609|NCT00972504|147452522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.9|-0.8||||||||-0.8|-1.9|
73958610|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.0|0.3|||||Comparison of Nasal Blockage between Placebo and GSK1004723 1000 µg once daily.|||0.3|-0.0|
73958611|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and GSK835726 10 mg once daily.|||-0.1|-0.4|
73958612|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and Cetirizine 10 mg once daily.|||-0.1|-0.4|
74019932|NCT03932799|147592053|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|0.16||||0.053|TWO_SIDED|95.0|0.0|0.32||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.32|-0.00|.053
73958613|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Rhinorrhoea between Placebo and GSK1004723 1000 µg once daily.|||-0.1|-0.4|
73958614|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.6|-0.2|||||Comparison of Rhinorrhoea between Placebo and GSK835726 10 mg once daily.|||-0.2|-0.6|
73958615|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.6|-0.3|||||Comparison of Rhinorrhoea between Placebo and Cetirizine 10 mg once daily.|||-0.3|-0.6|
73958616|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Itching between Placebo and GSK1004723 1000 µg once daily.|||-0.1|-0.4|
73958617|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and GSK835726 10 mg once daily.|||-0.2|-0.5|
73958618|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and Cetirizine 10 mg once daily.|||-0.2|-0.5|
73958619|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and GSK1004723 1000 µg once daily.|||-0.2|-0.5|
73958620|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.4|-0.2|||||Comparison of Sneezing between Placebo and GSK835726 10mg once daily.|||-0.2|-0.4|
73958621|NCT00972504|147452523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and Cetirizine 10mg once daily.|||-0.2|-0.5|
73958622|NCT00972504|147452524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.041|STANDARD_ERROR_OF_MEAN|0.4194|||TWO_SIDED|95.0|-1.87|-0.212||||||||-0.212|-1.870|
73958623|NCT00972504|147452524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.4172|||TWO_SIDED|95.0|-2.584|-0.936||||||||-0.936|-2.584|
73958624|NCT00972504|147452524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.792|STANDARD_ERROR_OF_MEAN|0.4224|||TWO_SIDED|95.0|-3.626|-1.957||||||||-1.957|-3.626|
74080431|NCT04547192|147713426|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|354.91||||0.001|TWO_SIDED||||||generalized linear mixed regression|||For Spine Immobilized for RTI or Fall Victims||||0.001
73897616|NCT01221272|147328304|SUPERIORITY_OR_OTHER||Mixed Models Analysis|0.67||||0.29|TWO_SIDED|95.0|-0.6|1.9||The null hypothesis that ranolazine treatment had no effect on PDS would be rejected if the PDS and TPD p-values were less than 0.05 or the PDS p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis|||||1.9|-0.6|0.29
73958625|NCT00972504|147452525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|95.0|-0.28|0.93||||||||0.93|-0.28|
73958626|NCT00972504|147452525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-1.65|-0.45||||||||-0.45|-1.65|
73958627|NCT00972504|147452525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|0.308||||95.0|-1.68|-0.46||||||||-0.46|-1.68|
73958628|NCT04246762|147452528|OTHER||geometric LS mean ratio of AUC (0-inf))|70.46|||||TWO_SIDED|90.0|60.62|81.91|||||Results based on a linear mixed model for the log-transformed values of PK parameters of midazolam with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (midazolam (as part of a 4-drug oral cocktail) after OKZ administration compared to midazolam (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||81.91|60.62|
73958629|NCT04246762|147452528|OTHER||geometric LS mean ratio of AUC (0-inf))|67.87|||||TWO_SIDED|90.0|56.73|81.21|||||Results based on a linear mixed model for the log-transformed values of PK parameters of omeprazole with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (omeprazole (as part of a 4-drug oral cocktail) after OKZ administration compared to omeprazole (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||81.21|56.73|
73958630|NCT04246762|147452528|OTHER||geometric LS mean ratio of AUC (0-inf))|122.92|||||TWO_SIDED|90.0|107.98|139.93|||||Results based on a linear mixed model for the log-transformed values of baseline-adjusted PK parameters of caffeine with a with fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (caffeine (as part of a 4-drug oral cocktail) after OKZ administration compared to caffeine (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||139.93|107.98|
73970919|NCT04103580|147481870|SUPERIORITY||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.005||0.247|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 1.||||0.247
74019933|NCT03932799|147592054|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|0.22||||0.01|TWO_SIDED|95.0|0.05|0.38||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.38|0.05|.01
73897617|NCT01221272|147328305|SUPERIORITY_OR_OTHER||Mixed Models Analysis|0.65||||0.22|TWO_SIDED|95.0|-0.4|1.7||The null hypothesis that ranolazine treatment had no effect on TPD would be rejected if the PDS and TPD p-values were less than 0.05 or the TPD p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis|||||1.7|-0.4|0.22
73958631|NCT04246762|147452529|OTHER||geometric LS mean ratio of AUC (0-last))|90.83|||||TWO_SIDED|90.0|86.72|95.13|||||Results based on a linear mixed model for the log-transformed values of PK parameters of S-warfarin with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (S-warfarin (as part of a 4-drug oral cocktail) after OKZ administration compared to initial S-warfarin administrated alone (as part of a 4-drug oral cocktail)) and its corresponding 90% confidence interval (CI) was calculated. The mean difference and the CI were back transformed to the original scale to obtain estimate of the geometric mean ratio and the associated 90% CI.||95.13|86.72|
73958632|NCT04246762|147452530|OTHER||geometric LS mean ratio of Cmax|68.5|||||TWO_SIDED|90.0|59.46|78.92|||||Results based on a linear mixed model for the log-transformed values of PK parameters of midazolam with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (midazolam (as part of a 4-drug oral cocktail) after OKZ administration compared to midazolam (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||78.92|59.46|
73958633|NCT04246762|147452530|OTHER||geometric LS mean ratio of Cmax|73.54|||||TWO_SIDED|90.0|64.18|84.27|||||Results based on a linear mixed model for the log-transformed values of PK parameters of omeprazole with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (omeprazole (as part of a 4-drug oral cocktail) after OKZ administration compared to omeprazole (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||84.27|64.18|
73958634|NCT04246762|147452530|OTHER||geometric LS mean ratio of Cmax|97.99|||||TWO_SIDED|90.0|91.36|105.09|||||Results based on a linear mixed model for the log-transformed values of baseline-adjusted PK parameters of caffeine with a with fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (caffeine (as part of a 4-drug oral cocktail) after OKZ administration compared to caffeine (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||105.09|91.36|
73958635|NCT04246762|147452530|OTHER||geometric LS mean ratio of Cmax|102.3|||||TWO_SIDED|90.0|94.8|110.39|||||Results based on a linear mixed model for the log-transformed values of PK parameters of S-warfarin with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (S-warfarin (as part of a 4-drug oral cocktail) after OKZ administration compared to initial S-warfarin administrated alone (as part of a 4-drug oral cocktail)) and its corresponding 90% confidence interval (CI) was calculated. The mean difference and the CI were back transformed to the original scale to obtain estimate of the geometric mean ratio and the associated 90% CI. The sample size computation was based on results reported for sirukumab.||110.39|94.80|
73958636|NCT01227707|147452555|SUPERIORITY_OR_OTHER|||||||1|||||||one sample binomial test|||||||1.00
73958637|NCT01093534|147452584|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.169||||0.095|TWO_SIDED|95.0|-0.368|0.03||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|ANCOVA|ANCOVA model with fixed effects for treatment and region and Baseline of least squares mean BWT as a covariate.||The null hypothesis was that the mean change from Baseline in BWT in the pooled solifenacin group and placebo was the same. Estimated as two-sided contrast with 95% confidence interval. Power was planned for 80% (assumption: mean difference = 0.5 mm, standard deviation=1.65, 314 and 157 participants, bonferroni adjustment for alpha =0.025)||0.030|-0.368|0.095
73958638|NCT01093534|147452585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||||||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|Wilcoxon (Mann-Whitney)|Nonparametric Wilcoxon rank-sum test does not adjust for other factors.||The null hypothesis for the co-primary treatment comparison was that the mean free (neutralized) uNGF/Cr value in the pooled solifenacin group and placebo was the same. Wilcoxon rank-sum test was used instead of a contrast from analysis of covariance (ANCOVA), because data was not normally distributed. Power was planned for 80% (assumption: mean difference = 0.74 pg/μmol, standard deviation=2.0, 220 and 110 participants, bonferroni adjustment for alpha =0.025).||||0.250
73958639|NCT00281918|147452609|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<.0001
74080432|NCT04547192|147713426|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|4.95||||0.001|TWO_SIDED||||||generalized linear mixed regression|||Splinting of Fractures Considered||||0.001
74080433|NCT04547192|147713426|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|5.18||||0.006|TWO_SIDED||||||generalized linear mixed regression|||Tetanus Considered for bites, burns, lacerations, and abrasions||||0.006
74019934|NCT03932799|147592055|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.76||||0.35|TWO_SIDED|95.0|0.42|1.35||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.35|0.42|.35
74019935|NCT01097629|147592078|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|26.3|||<|1e-05|TWO_SIDED|95.0|18.3|34.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||34.3|18.3|<0.00001
74019936|NCT01097629|147592079|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|25.1|||<|1e-05||95.0|16.0|34.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||34.2|16.0|<0.00001
73958640|NCT00281918|147452610|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<.0001
73958641|NCT00281918|147452611|SUPERIORITY_OR_OTHER|||||||0.0427||95.0|||||Log Rank|||||||0.0427
74019937|NCT01097629|147592080|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-29.4|||<|1e-05|TWO_SIDED|95.0|-36.6|-22.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-22.3|-36.6|<0.00001
74080434|NCT04547192|147713426|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|0.03||||0.047|TWO_SIDED||||||generalized linear mixed regression|||Date of Injury Recorded||||0.047
73958642|NCT00281918|147452612|SUPERIORITY_OR_OTHER|||||||0.7882||95.0|||||Log Rank|||||||0.7882
73958643|NCT00281918|147452613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.48|0.67|||Log Rank|||||0.67|0.48|<.0001
73958644|NCT00281918|147452614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.001|TWO_SIDED|95.0|0.54|0.86|||Log Rank|||||0.86|0.54|0.0010
74080435|NCT04547192|147713426|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|0.42||||0.166|TWO_SIDED||||||generalized linear mixed regression|||Death||||0.166
73958645|NCT00281918|147452615|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001||95.0|0.48|0.67|||Log Rank|||||0.67|0.48|<.0001
73958646|NCT00281918|147452616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0523|TWO_SIDED|95.0|0.52|1.02|||Log Rank|||||1.02|0.52|0.0523
73958647|NCT00281918|147452617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.48|0.71|||Log Rank|||||0.71|0.48|<.0001
73958648|NCT00281918|147452618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.62|3.28|||Chi-squared|||||3.28|1.62|<.0001
73958649|NCT00281918|147452619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.49|0.72|||Log Rank|||||0.72|0.49|<.0001
73958650|NCT01199237|147452620|SUPERIORITY_OR_OTHER|||||||0.11||||||Significant at p\<0.05|Chi-squared|||||||0.11
73958651|NCT03360396|147452639|OTHER|Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.||||||||||||Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.||Study was closed early in all regions except for France. SAP was updated to include descriptive statistics only. French sites remain open.||Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.|Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.|||
74019938|NCT01097629|147592081|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-29.4|||<|1e-05|TWO_SIDED|95.0|-36.7|-22.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-22.1|-36.7|<0.00001
74080436|NCT04547192|147713426|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|2.14||||0.013|TWO_SIDED||||||generalized linear mixed regression|||Important Clinical Data Document||||0.013
73836175|NCT03300336|147221373|SUPERIORITY||Mean Difference (Net)|1.56||||0.66|TWO_SIDED|95.0|-3.14|6.25||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||6.25|-3.14|0.66
73958652|NCT03360396|147452640|OTHER|Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||||||||||||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.|Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.|||
73958653|NCT01123083|147452649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.051|TWO_SIDED|95.0|-0.17|0.0|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|||0.00|-0.17|0.051
73958654|NCT01123083|147452650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.022|TWO_SIDED|95.0|-0.18|-0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Week 12||-0.02|-0.18|0.022
73958655|NCT01123083|147452650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.191|TWO_SIDED|95.0|-0.15|0.03|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.03|-0.15|0.191
73958656|NCT01123083|147452652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.912|TWO_SIDED|95.0|0.5|3.37|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Week 12||3.37|0.50|0.912
73958657|NCT01123083|147452652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.912|TWO_SIDED|95.0|0.37|2.42|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 6||2.42|0.37|0.912
73958658|NCT01123083|147452652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.412|TWO_SIDED|95.0|0.54|4.52|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 12||4.52|0.54|0.412
74080437|NCT04547192|147713427|SUPERIORITY||Odds Ratio (OR)|0.42||||0.166|TWO_SIDED||||||generalized linear mixed regression|||||||0.166
73958659|NCT01123083|147452653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.21|TWO_SIDED|95.0|-0.08|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Week 12||0.02|-0.08|0.210
73958660|NCT01123083|147452653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.21|TWO_SIDED|95.0|-0.11|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.02|-0.11|0.210
73958661|NCT01123083|147452653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.402|TWO_SIDED|95.0|-0.05|0.13|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 12||0.13|-0.05|0.402
73958662|NCT01123083|147452654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.582|TWO_SIDED|95.0|-0.52|0.16|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Week 12||0.16|-0.52|0.582
73958663|NCT01123083|147452654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.46|0.45|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.45|-0.46|0.987
73958664|NCT01123083|147452654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.572|TWO_SIDED|95.0|-0.33|0.59|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 12||0.59|-0.33|0.572
73958665|NCT01123083|147452657|SUPERIORITY_OR_OTHER|||||||0.452|||||||Hochberg-adjusted p-value|||Month 6||||0.452
73958666|NCT01123083|147452657|SUPERIORITY_OR_OTHER|||||||0.452|||||||Hochberg-adjusted p-value|||Month 12||||0.452
73958667|NCT01123083|147452658|SUPERIORITY_OR_OTHER|||||||0.123|||||||Hochberg-adjusted p-value|||Month 6||||0.123
73958668|NCT01123083|147452658|SUPERIORITY_OR_OTHER|||||||0.373|||||||Hochberg-adjusted p-value|||Month 12||||0.373
73958669|NCT00605033|147452670|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as a lower bound of the two-sided 95% confidence interval of the proportion difference greater than -0.15.|Proportion difference|-0.054|||||TWO_SIDED|95.0|-0.142|0.034|||Binomial approximation|||||0.034|-0.142|
73958670|NCT01867580|147452681|SUPERIORITY|||||||0.677|||||||Regression, Logistic|||||||0.6770
73958671|NCT01867580|147452682|SUPERIORITY|||||||0.0202|||||||Wilcoxon (Mann-Whitney)|||||||0.0202
74080438|NCT04723693|147713430|OTHER||||||||||||||||||This is a qualitative interview study and as such no statistical analysis was carried out.|||
74080439|NCT04723693|147713431|OTHER||||||||||||||||||This is a qualitative interview study and as such no statistical analysis was carried out.|||
74019939|NCT01097629|147592082|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.8||||3e-05|TWO_SIDED|95.0|-18.8|-6.9||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.9|-18.8|0.00003
74019940|NCT01097629|147592083|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.2||||3e-05|TWO_SIDED|95.0|-19.4|-7.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-7.0|-19.4|0.00003
74019941|NCT01097629|147592084|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.1||||4e-05|TWO_SIDED|95.0|-17.8|-6.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.4|-17.8|0.00004
74019942|NCT01097629|147592085|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-3.6||||0.2651|TWO_SIDED|95.0|-10.1|2.8||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||2.8|-10.1|0.26510
74019943|NCT01097629|147592086|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|26.4|||<|1e-05|TWO_SIDED|95.0|19.8|33.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||33.1|19.8|<0.00001
74019944|NCT01097629|147592087|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-42.0|||<|1e-05|TWO_SIDED|95.0|-48.6|-35.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-35.3|-48.6|<0.00001
73958672|NCT01867580|147452683|SUPERIORITY|||||||0.0142|||||||Regression, Logistic|||||||0.0142
74080440|NCT01339247|147713442|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0886|||||TWO_SIDED|90.0|1.0011|1.177|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.1770|1.0011|
73836176|NCT03300336|147221374|SUPERIORITY||Mean Difference (Net)|-0.52||||0.81|TWO_SIDED|95.0|-4.74|3.7||a priori threshold for significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect.. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 14 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.70|-4.74|0.81
73930688|NCT03238911|147391291|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.2368|TWO_SIDED|95.0|-0.78|3.12|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.12|-0.78|0.2368
73958673|NCT05372094|147452735|OTHER|||||||0.007|||||||Mixed Models Analysis|||Fixed factor of program and random intercept of participant||||0.007
73958674|NCT05372094|147452735|OTHER||||||<|0.05|||||||Mixed Models Analysis|||Follow up comparison between noise reduction setting OFF and noise reduction setting STRONG||||< 0.05
73958675|NCT05372094|147452735|OTHER||||||<|0.01|||||||Mixed Models Analysis|||Follow up comparison between noise reduction setting STRONG and noise reduction setting WEAK||||<0.01
73958676|NCT05372094|147452735|OTHER||||||>|0.05|||||||Mixed Models Analysis|||"Follow up comparison between ratings of effort with OFF and WEAK"||||>.05
73958677|NCT05372094|147452736|OTHER|||||||0.283|||||||Mixed Models Analysis|||||||0.283
74019945|NCT01097629|147592088|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.1|||<|1e-05|TWO_SIDED|95.0|-17.7|-8.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-8.4|-17.7|<0.00001
74019946|NCT01097629|147592089|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-21.7|||<|1e-05|TWO_SIDED|95.0|-28.6|-14.9|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-14.9|-28.6|<0.00001
74019947|NCT02613208|147592107|OTHER|Correlation analysis|Spearman coefficient|0.392|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering baseline CTC count||||<0.001
74019948|NCT02613208|147592107|OTHER|Correlation analysis|Spearman coefficient|0.088||||0.444|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering CTC count at cycle 2||||0.444
74019949|NCT02613208|147592109|OTHER|Correlation analysis|Spearman coefficient|0.373|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering baseline CTC count||||<0.001
74019950|NCT02613208|147592109|OTHER|Correlation analysis|Spearman coefficient|0.129||||0.241|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering CTC count at cycle 2||||0.241
74019951|NCT01400932|147592112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.0|||<|0.001|TWO_SIDED|95.0|-26.2|-15.8|||ANCOVA|||||-15.8|-26.2|<0.001
74019952|NCT01400932|147592113|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1|ANCOVA|||||||<0.001
74019953|NCT01400932|147592113|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2|ANCOVA|||||||<0.001
74019954|NCT01400932|147592113|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4|ANCOVA|||||||<0.001
74019955|NCT01400932|147592113|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8|ANCOVA|||||||<0.001
73897618|NCT01106092|147328312|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix™/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||4.72|-4.78|
73958678|NCT05372094|147452737|OTHER|||||||0.145|||||||Mixed Models Analysis|||Analysis was done only between NR OFF and NR at a custom or preferred setting.||||0.145
73958679|NCT05372094|147452738|OTHER|||||||0.3018|||||||Exact Binomial test|||An exact binomial test was performed to evaluate if the majority of teens and pre-teens with mild to severe hearing loss preferred NR setting (i.e., either weak or strong) to the NR setting OFF.||||0.3018
74019956|NCT01400932|147592114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; IL|ANCOVA|||||||<0.001
74019957|NCT01400932|147592114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; IL|ANCOVA|||||||<0.001
74019958|NCT01400932|147592114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; IL|ANCOVA|||||||<0.001
74019959|NCT01400932|147592114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; IL|ANCOVA|||||||<0.001
74019960|NCT01400932|147592114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; IL|ANCOVA|||||||<0.001
74019961|NCT01400932|147592114|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Week 1; NIL|ANCOVA|||||||0.007
74019962|NCT01400932|147592114|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||Week 2; NIL|ANCOVA|||||||0.008
74019963|NCT01400932|147592114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; NIL|ANCOVA|||||||<0.001
74019964|NCT01400932|147592114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; NIL|ANCOVA|||||||<0.001
74019965|NCT01400932|147592114|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; NIL|ANCOVA|||||||<0.001
74080441|NCT01339247|147713443|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0246|||||TWO_SIDED|90.0|0.9676|1.0849|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.0849|0.9676|
74019966|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; Total|ANCOVA|||||||<0.001
74019967|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; Total|ANCOVA|||||||<0.001
74019968|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; Total|ANCOVA|||||||<0.001
74019969|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; Total|ANCOVA|||||||<0.001
74019970|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; Total|ANCOVA|||||||<0.001
74019971|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; IL|ANCOVA|||||||<0.001
74019972|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; IL|ANCOVA|||||||<0.001
74019973|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; IL|ANCOVA|||||||<0.001
74019974|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; IL|ANCOVA|||||||<0.001
74019975|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; IL|ANCOVA|||||||<0.001
74019976|NCT01400932|147592115|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Week 1; NIL|ANCOVA|||||||0.002
74019977|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; NIL|ANCOVA|||||||<0.001
74019978|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; NIL|ANCOVA|||||||<0.001
74019979|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; NIL|ANCOVA|||||||<0.001
74019980|NCT01400932|147592115|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; NIL|ANCOVA|||||||<0.001
74019981|NCT01400932|147592116|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74019982|NCT01400932|147592117|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||Week 1|ANCOVA|||||||0.174
74019983|NCT01400932|147592117|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||Week 2|ANCOVA|||||||0.013
74019984|NCT01400932|147592117|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Week 4|ANCOVA|||||||0.001
74019985|NCT01400932|147592117|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Week 8|ANCOVA|||||||0.001
73836177|NCT03300336|147221375|SUPERIORITY||Odds Ratio (OR)|1.13||||0.74|TWO_SIDED|95.0|0.55|2.32||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 0 out of 227 Missing data due to item nonresponse in intervention: 5 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||2.32|0.55|0.74
73930689|NCT03238911|147391291|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.8287|TWO_SIDED|95.0|-2.18|1.75|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.75|-2.18|0.8287
73958680|NCT05372094|147452739|OTHER|||||||0.1796|||||||Exact Binomial test|||Exact binomial test was done to evaluate if the majority (\>50%) of teens and pre-teens prefer to use Tap Control to access Bluetooth streaming, compared to using the HA push button or phone controls.||||0.1796
74019986|NCT01400932|147592117|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12|ANCOVA|||||||<0.001
74019987|NCT01400932|147592118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1|ANCOVA|||||||<0.001
74019988|NCT01400932|147592118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2|ANCOVA|||||||<0.001
74019989|NCT01400932|147592118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4|ANCOVA|||||||<0.001
74019990|NCT01400932|147592118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8|ANCOVA|||||||<0.001
74019991|NCT01400932|147592118|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12|ANCOVA|||||||<0.001
74019992|NCT01276821|147592127|NON_INFERIORITY_OR_EQUIVALENCE|Non - Inferiority Analysis|Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|1.3|<|0.05|TWO_SIDED|95.0|0.78|1.82|||t-test, 2 sided|||"Null Hypothesis Efficacy of nebulised hypertonic saline (3%) with L-Epinephrine is not higer than as compared to L-Epinephrine given with 0.9% normal saline in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis.~Alternate Hypothesis:~Nebulised hypertonic saline (3%) with L-Epinephrine is superior to 0.9% Normal saline with L-Epinephrine in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis."||1.82|0.78|<0.05
74019993|NCT02939131|147592158|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not. The study was designed for at least 80% power to detect an effect size of 0.8 standard deviations (SD), which corresponded to a difference of four points. We assumed an intracluster correlation coefficient (ICC) between 0.02 and 0.16 and allowed for 10% non-evaluability. In a pre-planned interim analysis, we estimated the ICC based on the entry QIDS-SR to be 0.10.|Mean Difference (Final Values)|-3.86||||0.01|TWO_SIDED|95.0|-6.79|-0.94|||t-test, 2 sided||We subtracted the mean of the ESC group from the mean of the COMB-R group. Because a lower score indicated less severe depressive symptoms, a negative value indicated superiority.|||-0.94|-6.79|0.01
74019994|NCT02939131|147592159|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|44.3|||<|0.001|TWO_SIDED|95.0|23.1|65.5|||t-test, 2 sided||We subtracted the group mean of the site percents with response for the ESC group from that of the COMB-R group. A positive value indicates the COMB-R group had a higher mean percent of participants with response compared to the ESC group.|||65.5|23.1|<0.001
74019995|NCT02939131|147592160|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|30.9||||0.01|TWO_SIDED|95.0|8.9|52.9|||t-test, 2 sided||We subtracted the group mean of the site percents with remission for the ESC group from the COMB-R group so a positive value indicates the COMB-R group has more participants with remission.|||52.9|8.9|0.01
74019996|NCT02939131|147592161|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|19.0||||0.86|TWO_SIDED|95.0|-223.0|262.0|||t-test, 2 sided||Group mean for ESC is subtracted from the group mean for COMB-R. The group means are the means of the site mean CD4 cell counts.|||262|-223|0.86
74019997|NCT02939131|147592162|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|0.17||||0.66|TWO_SIDED|95.0|-0.65|0.99|||t-test, 2 sided||We subtracted the group mean for the ESC group from the group mean of the COMB-R group. The group means are the means of the site mean log10 HIV RNA copies/mL.|||0.99|-0.65|0.66
74019998|NCT02939131|147592163|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.04|TWO_SIDED|95.0|0.1|4.0|||t-test, 2 sided||A positive difference indicates COMB-R group had a site-level average of more days in last 30 with missed HIV medication doses.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed HIV medication doses reported at week 24.||4.0|0.1|0.04
74019999|NCT02939131|147592163|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.96|TWO_SIDED|95.0|-5.0|5.2|||t-test, 2 sided||A positive difference reflects greater number of days with missed HIV medication doses in last 30 days for COMB-R group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed HIV medication doses reported at week 48.||5.2|-5.0|0.96
74020000|NCT02939131|147592164|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.27|TWO_SIDED|95.0|-1.1|0.4|||t-test, 2 sided||A positive difference means the COMB-R group rated adherence to HIV medications better than the ESC group.|Comparison of COMB-R and ESC groups, how good was participant at taking HIV medication doses; reported at week 24.||0.4|-1.1|0.27
74020001|NCT02939131|147592164|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.44|TWO_SIDED|95.0|-0.4|0.9|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how good was participant at taking HIV medication doses; reported at week 48.||0.9|-0.4|0.44
74020002|NCT02939131|147592165|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.14|TWO_SIDED|95.0|-1.1|0.2|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take HIV medication as instructed; reported at week 24.||0.2|-1.1|0.14
74020003|NCT02939131|147592165|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.49|TWO_SIDED|95.0|-0.6|1.1|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take HIV medication as instructed; reported at week 48.||1.1|-0.6|0.49
73958681|NCT01183780|147452759|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.0219|TWO_SIDED|95.0|0.73|0.976|||Log Rank|The analysis was performed on stratified data.|The estimation was performed on stratified data.|||0.976|0.730|0.0219
73958682|NCT01183780|147452760|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.793||||0.0005|TWO_SIDED|95.0|0.697|0.903|||Log Rank|Analysis was performed on stratified data.|Analysis was performed on stratified data.|||0.903|0.697|0.0005
73958683|NCT01183780|147452761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6336|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6336
73958684|NCT02371746|147452792|SUPERIORITY||Change from baseline|30.4|STANDARD_DEVIATION|1.84|<|0.001|TWO_SIDED|95.0|-1.8|36.6|||ANCOVA|||estimatCohort 1 all Groups: Non-study eye: TRAVANTAN Z Cohort 1 - Group 1: Study Eye: 28.2 ug travoprost Cohort 1 - Group 2: Study Eye: 42.3 ug travoprost Cohort 1 - Group 3: Study Eye: 42 .5 ug travoprost Cohort 1 - Group 4: Study Eye: 85.0 ug travoprost||36.6|-1.8|<0.001
73958685|NCT02613364|147452793|NON_INFERIORITY|Non-inferiority is established if the difference in mean change on the ISI between YOCAS©® and CBT-I is less than 1.15. Using ANCOVA to estimate differences in mean change between YOCAS©® and CBT-I, a correlation of 0.576 (from our prior study), and a sample of 168 subjects per group, we will have sufficient (80%) power to detect non-inferiority using a margin of 1.15 at p = 0.025.|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|2.66|4.37||The p-value shown above is from the Least Squares Mean between YOCAS - CBT-I from the Mixed Model.|Mixed Models Analysis||The comparison is YOCAS - CBT-I|Constructed a 95% confidence interval on the mean change of ISI from baseline between the arms (YOCAS - CBT-I). If the lower bound of the interval is less than 1.5 then we conclude that YOCAS is non-inferior.||4.37|2.66|<.0001
73958686|NCT02613364|147452794|SUPERIORITY|Using ANCOVA to estimate differences in mean change between YOCAS and health education, a correlation of 0.576 (from our prior study), and a sample size of 168 evaluable subjects per group, we will have sufficient power to detect differences on the ISI of at least 1.3, 1.5 and 1.6 (all larger than our 1.15 non-inferiority margin) at 80%, 90%, and 95% power, respectively|Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.42||0.0009|TWO_SIDED|95.0|-2.23|-0.58||the comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.58|-2.23|0.0009
74020004|NCT02939131|147592166|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.05|TWO_SIDED|95.0|0.0|4.4|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group had more days with missed depression medications than those in the ESC group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed depression medication doses reported at week 24.||4.4|0.0|0.05
74020005|NCT02939131|147592166|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.53|TWO_SIDED|95.0|-12.5|7.1|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported more days with missed doses than those in the ESC group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed depression medication doses reported at week 48.||7.1|-12.5|0.53
73958687|NCT02613364|147452795|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.26||0.07|TWO_SIDED|95.0|-0.98|0.04||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||0.04|-0.98|0.0700
73958688|NCT02613364|147452796|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.23|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|1.7|2.75||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||2.75|1.70|<.0001
73958689|NCT02613364|147452797|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|19.73|STANDARD_ERROR_OF_MEAN|7.03||0.0052|TWO_SIDED|95.0|5.91|33.54||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||33.54|5.91|0.0052
73958690|NCT02613364|147452798|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|15.94|STANDARD_ERROR_OF_MEAN|7.12||0.0258|TWO_SIDED|95.0|1.93|29.94||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis|||||29.94|1.93|0.0258
74020006|NCT02939131|147592167|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.13|TWO_SIDED|95.0|-1.5|0.2|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group were better at taking medications.|Comparison of COMB-R and ESC groups, how good was participant at taking depression medication; reported at week 24.||0.2|-1.5|0.13
73897619|NCT01106092|147328312|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||6.94|-3.53|
73958691|NCT02613364|147452799|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.92|TWO_SIDED|95.0|-0.053|0.048||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|||0.048|-0.053|0.92
73958692|NCT02613364|147452800|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.026||0.07|TWO_SIDED|95.0|-0.004|0.098||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to the CBT-I control is a traditional null hypothesis of no difference with a two-sided alpha.||0.098|-0.004|0.07
73958693|NCT02613364|147452801|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|1.11||0.04|TWO_SIDED|95.0|0.09|4.44||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||4.44|0.09|0.04
73958694|NCT02613364|147452802|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|1.12||0.49|TWO_SIDED|95.0|-2.97|1.43||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||1.43|-2.97|0.49
73958695|NCT02613364|147452803|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.43|TWO_SIDED|95.0|-0.13|0.05||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||0.05|-0.13|0.43
73958696|NCT02613364|147452804|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7|TWO_SIDED|95.0|-0.07|0.11||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||0.11|-0.07|0.70
73958697|NCT02613364|147452805|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.55||0.0041|TWO_SIDED|95.0|-2.65|-0.5||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.50|-2.65|0.0041
73958698|NCT02613364|147452806|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.71|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|1.61|3.81||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||3.81|1.61|<.0001
74020007|NCT02939131|147592167|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.53|TWO_SIDED|95.0|-1.1|2.0|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group were better at taking their medications.|Comparison of COMB-R and ESC groups, how good was participant at taking depression medication; reported at week 48.||2.0|-1.1|0.53
74020008|NCT02939131|147592168|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.07|TWO_SIDED|95.0|-1.3|0.1|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported better adherence.|Comparison of COMB-R and ESC groups, how often did participant take depression medication as instructed; reported at week 24.||0.1|-1.3|0.07
74020009|NCT02939131|147592168|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.28|TWO_SIDED|95.0|-0.8|2.3|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported better adherence than those in the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take depression medication as instructed; reported at week 48.||2.3|-0.8|0.28
73836178|NCT03300336|147221376|SUPERIORITY||Mean Difference (Net)|0.02||||0.4|TWO_SIDED|95.0|-0.03|0.06||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 14 out of 227 Missing data due to item nonresponse in intervention: 33 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||0.06|-0.03|0.40
73836179|NCT03300336|147221377|SUPERIORITY||Mean Difference (Net)|0.03||||0.18|TWO_SIDED|95.0|-0.01|0.07||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 7 out of 227 Missing data due to item nonresponse in intervention: 23 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||0.07|-0.01|0.18
73836180|NCT03300336|147221378|SUPERIORITY||Mean Difference (Net)|0.8||||0.83|TWO_SIDED|95.0|-6.38|7.98||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 4 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||7.98|-6.38|0.83
74020010|NCT02939131|147592169|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.44|TWO_SIDED|95.0|-0.6|0.3|||t-test, 2 sided|||||0.3|-0.6|0.44
74020011|NCT02939131|147592171|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||The average number of scheduled study visits through week 24 was computed for each site. The analysis was of these site-level averages. These values were compared between study groups||0.3|-0.4|0.67
74020012|NCT02939131|147592171|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.74|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||We computed the average number of scheduled study visits through week 48 for each site. We then averaged the site-level values and compared study groups.||0.5|-0.7|0.74
74020013|NCT02939131|147592172|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.14|TWO_SIDED|95.0|-4.74|0.76|||t-test, 2 sided||We subtracted the mean of the ESC group from the mean of the COMB-R group. Because a lower score indicated less severe depressive symptoms, a negative value indicated superiority.|We tested the null hypothesis that the treatment group means were equal vs. not.||0.76|-4.74|0.14
74020014|NCT02939131|147592173|SUPERIORITY||Mean Difference (Final Values)|25.3||||0.05|TWO_SIDED|95.0|0.5|50.0|||t-test, 2 sided||We subtracted the group mean of the site percents with response for the ESC group from that of the COMB-R group. A positive value indicates the COMB-R group had a higher mean percent of participants with response compared to the ESC group.|We tested the null hypothesis that the treatment group means were equal vs. not.||50.0|0.5|0.05
74020015|NCT02939131|147592174|SUPERIORITY||Mean Difference (Final Values)|16.3||||0.24|TWO_SIDED|95.0|-12.3|44.8|||t-test, 2 sided||We subtracted the group mean of the site percents with remission for the ESC group from the COMB-R group so a positive value indicates the COMB-R group has more participants with remission.|We tested the null hypothesis that the treatment group means were equal vs. not.||44.8|-12.3|0.24
74020016|NCT02939131|147592175|SUPERIORITY||Mean Difference (Final Values)|6.79||||0.01|TWO_SIDED|95.0|2.3|11.28||This is the test of effect modification by sex at birth|t-test, 2 sided||A positive value indicates that the treatment difference (lower QIDS-SR score with COMB-R than with ESC) was greater for females compared to males.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||11.28|2.30|0.01
74020017|NCT02939131|147592175|SUPERIORITY||Mean Difference (Final Values)|-2.56||||0.23|TWO_SIDED|95.0|-7.05|1.93||This is the test of effect modification by age group|t-test, 2 sided||A negative value indicates the treatment difference is greater for younger compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||1.93|-7.05|0.23
74020018|NCT02939131|147592175|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.31|TWO_SIDED|95.0|-8.48|2.95||This is the test of the effect modification of viral suppression status|t-test, 2 sided||A negative value indicates a greater treatment difference among those with viral suppression at study entry compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups.Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||2.95|-8.48|0.31
74020019|NCT02939131|147592175|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.72|TWO_SIDED|95.0|-4.29|5.95||This is the test of effect modification by QIDS-SR depression level at study entry.|t-test, 2 sided||A positive value indicates a greater treatment difference among those with moderate levels of depression compared to severe depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups.Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||5.95|-4.29|0.72
74020020|NCT02939131|147592175|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.91|TWO_SIDED|95.0|-5.91|5.31||This is the test of effect modification by mode of transmission|t-test, 2 sided||A negative value would indicate a greater treatment difference for those with perinatal HIV acquisition compared to behavioral acquisition.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||5.31|-5.91|0.91
74020021|NCT02939131|147592175|SUPERIORITY||Mean Difference (Final Values)|1.33||||0.57|TWO_SIDED|95.0|-3.91|6.57||This is the test of effect modification by HIV CDC stage level|t-test, 2 sided||A positive value would indicate a greater treatment effect for those with less than HIV CDC Stage 3 compared to those with CDC Stage 3 HIV illness.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||6.57|-3.91|0.57
74020022|NCT02939131|147592175|SUPERIORITY||Mean Difference (Final Values)|5.93||||0.1|TWO_SIDED|95.0|-1.73|13.59||This is the test of effect modification of CD4 Stage 3 at entry.|t-test, 2 sided||A positive value indicates a greater treatment effect among those with less than Stage 3 CD4 count at entry compared to those with Stage 3 CD4 count.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups..||13.59|-1.73|0.10
74020023|NCT02939131|147592175|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.58|TWO_SIDED|95.0|-7.74|4.6||This is the test of effect modification by Nadir Stage 3 level at study entry.|t-test, 2 sided||A negative value indicates a greater treatment effect among those with Stage 3 Nadir CD4 compare to those with less than Stage 3 Nadir CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||4.60|-7.74|0.58
74020024|NCT02939131|147592176|SUPERIORITY||Mean Difference (Final Values)|-67.81||||0.01|TWO_SIDED|95.0|-116.53|-19.1||This is the test of effect modification by sex at birth.|t-test, 2 sided||A negative value indicates a greater treatment response (higher percent with response in COMB-R than in ESC group) among females compared to males.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||-19.10|-116.53|0.01
74080442|NCT01339247|147713444|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0317|||||TWO_SIDED|90.0|0.9716|1.0956|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.0956|0.9716|
73971411|NCT04508309|147483479|NON_INFERIORITY|Non-inferiority of Cecolin at Months 0 and 6 (Group 1) compared to Gardasil at Months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.933|1.344|||||GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.344|0.933|
74080443|NCT02412852|147713447|OTHER||||||||||||||||||\]The pharmacokinetics data are particularly sparse, and therefore substantial interpolations and imputations were required to produce an analyzable data set. Consequently, while not ideal, the Last Observation Carried Forward method was used for these data. There was a large amount of missing data which required imputation to determine results. The large amount of interpolations and imputations required for the pharmacokinetic analysis means that the pharmacokinetic results will need to be interpreted with caution. 3 X 3 Analysis of Variance used to compare Placebo to the two active groups. Missing data required imputation of available data.|||
74080444|NCT02412852|147713449|OTHER|ANOVA on only those subjects who completed testing.||||||0.05||||||The results were analyzed using an ANOVA with one between-subjects factor (Group: both placebo groups combined, 40 mg TV1001sr, and 80 mg TV1001sr); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).|ANOVA|The means of the three groups were further analyzed using a post hoc comparison procedure (the Scheffé test).||||||0.05
74080445|NCT02412852|147713450|OTHER|The composite conduction measure and the composite velocity measure were analyzed using an Analysis of Variance with one between-subjects factor (Group: combined placebo, 40 mg TV1001, and 80 mg TV1001); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).||||||0.15|||||||ANOVA|||||||.15
74080446|NCT02412852|147713451|OTHER|A 3 by 3 Analysis of Variance with one between-subjects factor (Combined placebo, 40 mg TV1001, or 80 mg TV1001) and one within-subjects factor (Visit 1, Visit 2, or Visit 3) was performed for HbA1c values.||||||0.36|||||||ANOVA|||||||.36
74020025|NCT02939131|147592176|SUPERIORITY||Mean Difference (Final Values)|43.08||||0.09|TWO_SIDED|95.0|-8.23|94.38||This is the test of effect modification by age group.|t-test, 2 sided||A positive value reflects a greater treatment effect among younger participants compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.38|-8.23|0.09
74020026|NCT02939131|147592176|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.93|TWO_SIDED|95.0|-51.13|55.49||This is the test of effect modification by viral suppression status.|t-test, 2 sided||A positive value would reflect a greater treatment response among those with suppressed viral status at entry compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||55.49|-51.13|0.93
74020027|NCT02939131|147592176|SUPERIORITY||Mean Difference (Final Values)|3.36||||0.87|TWO_SIDED|95.0|-42.28|49.0||This is the test of effect modification by entry QIDS-SR depression level.|t-test, 2 sided||A positive value would indicate a greater treatment response for those with severe depressive symptoms at study entry compared to those with moderate depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||49.00|-42.28|0.87
74020028|NCT02939131|147592176|SUPERIORITY||Mean Difference (Final Values)|41.65||||0.17|TWO_SIDED|95.0|-21.91|105.2||This is the test of effect modification by mode of transmission.|t-test, 2 sided||A positive value would indicate a larger treatment response for those with perinatal transmission compared to behavioral.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||105.20|-21.91|0.17
74020029|NCT02939131|147592176|SUPERIORITY||Mean Difference (Final Values)|49.4||||0.17|TWO_SIDED|95.0|-26.02|124.83||This is the test of effect modification by HIV CDC stage.|t-test, 2 sided||A positive value reflects a greater treatment response for those with HIV CDC Stage 3 classification compared to those with CDC classification less than Stage 3.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||124.83|-26.02|0.17
74020030|NCT02939131|147592176|SUPERIORITY||Mean Difference (Final Values)|11.69||||0.71|TWO_SIDED|95.0|-70.76|94.15||This is the test of effect modification by CD4 Stage at study entry.|t-test, 2 sided||A positive value would reflect greater treatment response for those with CD4 Stage 3 compared to those with less than Stage 3 CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.15|-70.76|0.71
73958699|NCT02613364|147452807|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.62||0.0108|TWO_SIDED|95.0|-2.78|-0.36||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.36|-2.78|0.0108
74020031|NCT02939131|147592176|SUPERIORITY||Mean Difference (Final Values)|52.48||||0.02|TWO_SIDED|95.0|10.46|94.5||This is the test of effect modification by CD4 Nadir stage at study entry.|t-test, 2 sided||A positive value reflects a larger treatment response among those with Stage 3 Nadir CD4 compared to those with less than Stage 3 Nadir CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.50|10.46|0.02
74020032|NCT02939131|147592177|SUPERIORITY||Mean Difference (Final Values)|-45.06||||0.09|TWO_SIDED|95.0|-97.84|7.72||This is the test of effect modification by sex at birth|t-test, 2 sided||A negative value indicates a greater treatment effect (higher percent with remission for COMB-R than for ESC) among females.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||7.72|-97.84|0.09
73930690|NCT03238911|147391292|SUPERIORITY||Mean Difference (Final Values)|24.27|||<|0.0001|TWO_SIDED|95.0|18.81|29.73|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||29.73|18.81|<0.0001
73958700|NCT02613364|147452808|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.78|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|1.54|4.02||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||4.02|1.54|<.0001
73958701|NCT01544062|147452855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.024|TWO_SIDED|95.0|2.3|31.1|||t-test, 2 sided|||||31.1|2.3|0.024
73958702|NCT01544062|147452855|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.013
73958703|NCT01544062|147452856|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||t-test, 2 sided|||||||0.059
73958704|NCT01544062|147452856|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.020
74020033|NCT02939131|147592177|SUPERIORITY||Mean Difference (Final Values)|1.41||||0.95|TWO_SIDED|95.0|-43.38|46.2||This is the test of effect modification by age group.|t-test, 2 sided||A positive value would reflect a larger treatment effect among younger participants compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||46.20|-43.38|0.95
74020034|NCT02939131|147592177|SUPERIORITY||Mean Difference (Final Values)|5.59||||0.79|TWO_SIDED|95.0|-40.47|51.65||This is the test of effect modification by viral suppression status.|Wilcoxon (Mann-Whitney)||A positive value would reflect a greater treatment effect among those with suppressed viral load compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||51.65|-40.47|0.79
74020035|NCT02939131|147592177|SUPERIORITY||Mean Difference (Final Values)|-15.97||||0.42|TWO_SIDED|95.0|-58.88|26.94||This is the test of effect modification by QIDS-SR level at entry.|t-test, 2 sided||A negative value would reflect a greater treatment effect among those with moderate depression symptomatology at entry compared to those with severe depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||26.94|-58.88|0.42
74020036|NCT02939131|147592177|SUPERIORITY||Mean Difference (Final Values)|9.99||||0.68|TWO_SIDED|95.0|-41.24|61.22||This is the test of effect modification by mode of transmission.|t-test, 2 sided||A positive value would reflect a greater treatment effect among those with perinatal transmission compared to behavioral transmission.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||61.22|-41.24|0.68
74080447|NCT02412852|147713452|OTHER|ANOVA to compare differences from baseline to completion of testing.||||||0.93|||||||ANOVA|||||||.93
74080448|NCT00909753|147713471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.5||||||90.0|85.8|99.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.7|85.8|
74080449|NCT00909753|147713472|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.5||||||90.0|92.2|98.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.9|92.2|
74080450|NCT00909753|147713473|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.3|83.1|
73958705|NCT01544062|147452857|SUPERIORITY_OR_OTHER|||||||0.724|TWO_SIDED||||||t-test, 2 sided|||||||0.724
74080451|NCT00909753|147713474|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.5|95.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||95.9|85.5|
73958706|NCT01544062|147452857|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.510
73958707|NCT01544062|147452858|SUPERIORITY_OR_OTHER|||||||0.397|TWO_SIDED||||||t-test, 2 sided|||||||0.397
73958708|NCT01544062|147452858|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.458
73958709|NCT01544062|147452859|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.600
73958710|NCT01544062|147452859|SUPERIORITY_OR_OTHER|||||||0.509|TWO_SIDED||||||ANCOVA|controlling for age, sex and body mass index||||||0.509
73958711|NCT01544062|147452860|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||t-test, 2 sided|||||||0.399
73958712|NCT01544062|147452860|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.395
73958713|NCT01544062|147452861|SUPERIORITY_OR_OTHER|||||||0.771|TWO_SIDED||||||t-test, 2 sided|||||||0.771
73958714|NCT01544062|147452861|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.927
73958715|NCT01544062|147452862|SUPERIORITY_OR_OTHER|||||||0.644|TWO_SIDED||||||t-test, 2 sided|||||||0.644
73958716|NCT01544062|147452862|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.160
73958717|NCT01544062|147452863|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||t-test, 2 sided|||||||0.710
74020037|NCT02939131|147592177|SUPERIORITY||Mean Difference (Final Values)|-14.21||||0.57|TWO_SIDED|95.0|-70.62|42.2||This is the test of effect modification by HIV CDC stage.|t-test, 2 sided||A positive value would reflect a greater treatment response among those with HIV CDC Stage 3 classification compared to those with less than Stage 3 classification.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||42.20|-70.62|0.57
74020038|NCT02939131|147592177|SUPERIORITY||Mean Difference (Final Values)|-44.97||||0.26|TWO_SIDED|95.0|-141.12|51.17||This is the test of effect modification by CD4 Stage.|t-test, 2 sided||A negative value would reflect a greater treatment effect among those with less than Stage 3 CD4 levels compared to those with Stage 3 CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||51.17|-141.12|0.26
74020039|NCT02939131|147592177|SUPERIORITY||Mean Difference (Final Values)|9.53||||0.72|TWO_SIDED|95.0|-52.97|72.02||This is the test of effect modification by CD4 nadir stage.|t-test, 2 sided||A positive value would reflect a greater treatment effect by those with Stage 3 CD4 Nadir compared to those with less than Stage 3.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||72.02|-52.97|0.72
74020040|NCT02939131|147592178|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.26|TWO_SIDED|95.0|-8.4|28.1|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with alcohol use ever at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||28.1|-8.4|0.26
74020041|NCT02939131|147592178|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.66|TWO_SIDED|95.0|-37.1|24.6|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with alcohol use ever at week 48 were computed for each site. These site-level percentages were compared across treatment groups.||24.6|-37.1|0.66
74020042|NCT02939131|147592179|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.71|TWO_SIDED|95.0|-22.3|31.7|||t-test, 2 sided||A positive value indicates higher site-level percentages in the COMB-R group.|The percent of participants with regular frequency alcohol use at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||31.7|-22.3|0.71
74020043|NCT02939131|147592179|SUPERIORITY||Mean Difference (Final Values)|26.7||||0.1|TWO_SIDED|95.0|-6.3|59.6|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group.|The percent of participants at each site with regular alcohol use at week 48 was computed. These site-level percents were compared across treatments||59.6|-6.3|0.10
74020044|NCT02939131|147592180|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.09|TWO_SIDED|95.0|-2.6|0.2|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group and vice versa.|The average number of drinks per day reported at week 24 was computed for each site and these site-level averages were compared across treatments.||0.2|-2.6|0.09
74020045|NCT02939131|147592180|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.79|TWO_SIDED|95.0|-0.8|1.0|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group and vice versa.|The site-level average numbers of drinks per day reported at week 48 were computed and these site-level averages were compared across treatment groups.||1.0|-0.8|0.79
74020046|NCT02939131|147592181|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.87|TWO_SIDED|95.0|-0.9|0.8|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group anc vice versa|The site-level average number of days with binge drinking at week 24 were computed and these site-level averages were compared across treatments.||0.8|-0.9|0.87
74020047|NCT02939131|147592181|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.8|0.8|||t-test, 2 sided||A positive difference would indicate site level averages were higher in the COMB-R group and vice versa|The site-level average number of days with binge drinking reported at week 48 were computed and the site-level averages were compared across treatment groups.||0.8|-0.8|0.99
74020048|NCT02939131|147592182|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.77|TWO_SIDED|95.0|-19.7|26.0|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with tobacco use ever at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||26.0|-19.7|0.77
74080452|NCT00909753|147713475|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.5|99.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.5|85.5|
74080453|NCT00909753|147713476|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.0||||||90.0|91.3|98.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.7|91.3|
73958718|NCT01544062|147452863|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.475
73958719|NCT01544062|147452864|SUPERIORITY_OR_OTHER|||||||0.508|TWO_SIDED||||||t-test, 2 sided|||||||0.508
73958720|NCT01544062|147452864|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.905
73958721|NCT01544062|147452865|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||t-test, 2 sided|||||||0.104
73958722|NCT01544062|147452866|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Fisher Exact|||||||0.580
73958723|NCT01544062|147452867|SUPERIORITY_OR_OTHER|||||||0.619|TWO_SIDED||||||Fisher Exact|||||||0.619
73958724|NCT01544062|147452868|SUPERIORITY_OR_OTHER|||||||0.511|TWO_SIDED||||||Fisher Exact|||||||0.511
74020049|NCT02939131|147592182|SUPERIORITY||Mean Difference (Final Values)|14.7||||0.2|TWO_SIDED|95.0|-8.9|38.4|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group.|The percent of participants with tobacco use ever at week 48 were computed for each site. These site-level percentages were compared across treatment groups.||38.4|-8.9|0.20
74020050|NCT02939131|147592183|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.09|TWO_SIDED|95.0|-2.8|33.3|||t-test, 2 sided||A positive difference would indicate the site level percentages were higher in the COMB-R group.|This is the analysis of regular use of tobacco at week 24. The percent of participants at each site with regular use was computed. These site-level percentages were compared across treatment groups.||33.3|-2.8|0.09
74020051|NCT02939131|147592183|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.21|TWO_SIDED|95.0|-14.0|55.3|||t-test, 2 sided||A positive difference indicates site-level percentages were higher in the COMB-R group.|This is the analysis of regular frequency use of tobacco at week 48. Site level percentages of the numbers of participants with regular tobacco use were computed and compared across treatment groups.||55.3|-14.0|0.21
74020052|NCT02939131|147592184|SUPERIORITY||Mean Difference (Final Values)|7.9||||0.41|TWO_SIDED|95.0|-12.4|28.3|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using marijuana (cannabis) reported at week 24 were computed and compared across treatment groups.||28.3|-12.4|0.41
74020053|NCT02939131|147592184|SUPERIORITY||Mean Difference (Final Values)|13.0||||0.26|TWO_SIDED|95.0|-10.9|36.8|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using marijuana (cannabis) reported at week 48 were computed and compared across treatment groups.||36.8|-10.9|0.26
74020054|NCT02939131|147592184|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.69|TWO_SIDED|95.0|-20.2|29.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using any illegal substance excluding marijuana (cannabis) reported at week 24 were computed and compared across treatment groups.||29.5|-20.2|0.69
74020055|NCT02939131|147592184|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.96|TWO_SIDED|95.0|-24.8|23.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using any illegal substance excluding marijuana (cannabis) reported at week 48 were computed and compared across treatment groups.||23.5|-24.8|0.96
74020056|NCT02939131|147592185|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.53|TWO_SIDED|95.0|-23.9|44.1|||t-test, 2 sided||A positive difference indicates a higher site-level percentage of participants reporting regular use fof marijuana in the COMB-R group compared to the ESC group.|This is the analysis for regular use of marijuana (cannabis) at week 24. The percent of participants at each site reporting regular use (of those reporting any use) was computed. These site-level percentages were averaged and compared across treatments.||44.1|-23.9|0.53
74020057|NCT02939131|147592185|SUPERIORITY||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-35.1|34.9|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular use of marijuana (cannabis) in the COMB-R group compared to the ESC group.|This is the analysis of regular use of marijuana (cannabis) at week 48. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||34.9|-35.1|1.0
74020058|NCT02939131|147592185|SUPERIORITY||Mean Difference (Final Values)|24.7||||0.18|TWO_SIDED|95.0|-16.2|65.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular substance use in the COMB-R group compared to the ESC group.|This is the analysis of regular use of any illegal substance, excluding cannabis, at week 24. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||65.5|-16.2|0.18
74080454|NCT00909753|147713477|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% COnfidence Interval falls within 80-125.|||98.3|83.1|
73958725|NCT01544062|147452869|SUPERIORITY_OR_OTHER|||||||0.501|TWO_SIDED||||||Fisher Exact|||||||0.501
74020059|NCT02939131|147592185|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.34|TWO_SIDED|95.0|-59.5|22.9|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular substance use in the COMB-R group compared to the ESC group.|This is the analysis of regular use of any illegal substance, excluding cannabis, at week 48. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||22.9|-59.5|0.34
74020060|NCT02939131|147592186|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.29|TWO_SIDED|95.0|-12.9|39.6|||t-test, 2 sided||A positive value would indicate higher site-level percents in the COMB-R group.|This is the analysis for week 24. The percentage of participants at a site who reported using sex as a commodity was calculated and the site-level percentages were averaged and compared across treatments.||39.6|-12.9|0.29
74020061|NCT02939131|147592186|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.7|TWO_SIDED|95.0|-17.0|24.5|||t-test, 2 sided||A positive difference would indicate site-level percentages were higher in the COMB-R group|This is the analysis for week 48. The percentage of participants at a site who reported using sex as a commodity was calculated and the site-level percentages were averaged and compared across treatments.||24.5|-17.0|0.70
74080455|NCT00909753|147713478|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.0|96.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.3|85.0|
74080456|NCT00841542|147713486|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.19||||||90.0|94.2|102.34|||||Bioequivalence is established when 90% Confidence Interval falls withing 80 - 125|||102.34|94.20|
74080457|NCT00841542|147713487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.86||||||90.0|93.38|104.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.66|93.38|
74020062|NCT02939131|147592187|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.71|TWO_SIDED|95.0|-13.7|19.4|||t-test, 2 sided||A positive difference indicates the site-level averages were higher for the COMB-R group.|This is the analysis for week 24. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||19.4|-13.7|0.71
74020063|NCT02939131|147592187|SUPERIORITY||Mean Difference (Final Values)|-4.7||||0.44|TWO_SIDED|95.0|-17.5|8.1|||t-test, 2 sided||A positive value would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||8.1|-17.5|0.44
74020064|NCT02939131|147592188|SUPERIORITY||Mean Difference (Final Values)|7.3||||0.23|TWO_SIDED|95.0|-5.3|19.8|||t-test, 2 sided||A positive value would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 24. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||19.8|-5.3|0.23
74020065|NCT02939131|147592188|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.73|TWO_SIDED|95.0|-17.5|12.7|||t-test, 2 sided||A positive difference would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||12.7|-17.5|0.73
74020066|NCT02939131|147592189|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.24|TWO_SIDED|95.0|-0.4|1.5|||t-test, 2 sided||A positive value would indicate site-level averages were higher in COMB-R group.|This is the analysis for week 24. Numbers of partners were averaged by site and the site-level averages were averaged and compared across treatment groups.||1.5|-0.4|0.24
74020067|NCT02939131|147592189|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.22|TWO_SIDED|95.0|-0.3|1.0|||t-test, 2 sided||A positive difference indicates site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Numbers of partners were averaged by site and the site-level averages were averaged and compared across treatment groups.||1.0|-0.3|0.22
74020068|NCT02939131|147592190|SUPERIORITY||Mean Difference (Final Values)|-8.3||||0.57|TWO_SIDED|95.0|-40.4|23.9|||t-test, 2 sided||A positive value would indicate higher site-level percents of low frequency condom use in COMB-R treatment group and vice versa.|This is the analysis for week 24 data. We computed the percent of participants reporting low frequency of condom use in past three months by site, averaged the site-level percents and compared these averages across treatment arms.||23.9|-40.4|0.57
74020069|NCT02939131|147592190|SUPERIORITY||Mean Difference (Final Values)|-21.8||||0.15|TWO_SIDED|95.0|-53.1|9.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|This is the analysis for week 48 data. We computed the percent of participants reporting low frequency of condom use in past three months by site, averaged the site-level percents and compared these averages across treatment arms.||9.5|-53.1|0.15
74020070|NCT02939131|147592191|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.65|TWO_SIDED|95.0|-40.9|27.2|||t-test, 2 sided||A positive difference would indicate site level percents were higher in the COMB-R group and vice versa.|We computed the site-level percentages of participants reporting low frequency condom use at week 24, then averaged the site-level percentages by treatment group and compared these group average percents.||27.2|-40.9|0.65
74020071|NCT02939131|147592191|SUPERIORITY||Mean Difference (Final Values)|-37.8||||0.02|TWO_SIDED|95.0|-69.7|-5.8|||t-test, 2 sided||A positive difference would indicate site-level percentages were higher in the COMB-R group and vice versa.|We computed the site-level percentages of participants reporting low frequency condom use at week 48, then averaged the site-level percentages by treatment group and compared these group average percents.||-5.8|-69.7|0.02
73958726|NCT01544062|147452870|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
74020072|NCT02939131|147592192|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.33|TWO_SIDED|95.0|-3.0|8.1|||t-test, 2 sided||A positive difference indicates COMB-R participants attended more sessions than ESC|We averaged the number of counseling sessions for each site and compared these site-level averages.||8.1|-3.0|0.33
74020073|NCT02939131|147592197|SUPERIORITY||Mean Difference (Final Values)|18.7||||0.06|TWO_SIDED|95.0|-0.9|38.2|||t-test, 2 sided||A positive difference indicates more participants in the COMB-R group were taking medications, based on site-level percentages.|This is the analysis for the percent of participants on any psychiatric medication at week 24. Site-level percentages were compared across treatments.||38.2|-0.9|0.06
74020074|NCT02939131|147592197|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.06|TWO_SIDED|95.0|-0.7|35.5|||t-test, 2 sided||A positive difference means the site-level percentages of those taking medications were higher in the COMB-R group.|This is the analysis of the percent of participants on antidepressant medications. Site-level percentages were compared across treatments.||35.5|-0.7|0.06
74020075|NCT02939131|147592197|SUPERIORITY||Mean Difference (Final Values)|22.4||||0.02|TWO_SIDED|95.0|4.2|40.6|||t-test, 2 sided||A positive difference indicates the site-level percentages of those taking medications were higher in the COMB-R group.|This is the analysis of the percent of participants on SSRI antidepressant medications. Site-level percentages were compared across treatments.||40.6|4.2|0.02
74020076|NCT02939131|147592197|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.54|TWO_SIDED|95.0|-17.3|9.6|||t-test, 2 sided||A positive difference would indicate site-level percentages of those on medication were higher in the COMB-R group.|This is the analysis of the percent of participants on non-SSRI antidepressant medications. Site-level percentages were compared across treatments.||9.6|-17.3|0.54
74020077|NCT02939131|147592197|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.6|TWO_SIDED|95.0|-25.4|15.4|||t-test, 2 sided||A positive value would indicate the site-level percentages of those on medications were higher in the COMB-R group.|This is the analysis of the percent of participants on non-antidepressant psychiatric medications. Site-level percentages were compared across treatments.||15.4|-25.4|0.60
74020078|NCT02939131|147592198|SUPERIORITY||Mean Difference (Final Values)|-3.8||||0.77|TWO_SIDED|95.0|-32.5|24.8|||t-test, 2 sided||A positive difference would indicate more time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on any psychiatric medication across treatment groups.||24.8|-32.5|0.77
73958727|NCT01544062|147452871|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Fisher Exact|||||||0.299
73958728|NCT01544062|147452872|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
74020079|NCT02939131|147592198|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.91|TWO_SIDED|95.0|-37.3|33.5|||t-test, 2 sided||A positive difference would indicate more study time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on single SSRI psychiatric medication across treatment groups.||33.5|-37.3|0.91
74020080|NCT02939131|147592198|SUPERIORITY||Mean Difference (Final Values)|-16.7||||0.4|TWO_SIDED|95.0|-60.2|26.9|||t-test, 2 sided||A positive value would indicate more time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on SSRI+other psychiatric medication across treatment groups.||26.9|-60.2|0.40
74020081|NCT02939131|147592198|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.52|TWO_SIDED|95.0|-67.0|40.1|||t-test, 2 sided||A positive difference would indicate more time on medication in COMB-R group.|This is the analysis comparing site-level mean percents of study time on a single non-SSRI psychiatric medication across treatment groups.||40.1|-67.0|0.52
74020082|NCT02939131|147592198|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.96|TWO_SIDED|95.0|-778.0|785.7|||t-test, 2 sided|Because of sparseness, the confidence intervals for this site-level analysis are very large.|A positive difference indicates more time on medication in the COMB-R group. There was data from only one site in the ESC group and 2 sites in the COMB-R group. The confidence interval for the difference is quite large and the test is unreliable.|This is the analysis comparing site-level mean percents of study time on non-SSRI+other psychiatric medication across treatment groups. This analysis is unstable because of sparseness.||785.7|-778.0|0.96
74020083|NCT02939131|147592198|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.74|TWO_SIDED|95.0|-31.4|23.0|||t-test, 2 sided||A positive difference would reflect more time on medications in the COMB-R group|This is the analysis comparing site-level mean percents of study time on antidepressant medication across treatment groups.||23.0|-31.4|0.74
74020084|NCT02939131|147592199|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.29|TWO_SIDED|95.0|-2.8|8.2|||t-test, 2 sided||A positive difference would indicate the site level average interim counseling sessions was higher in the COMB-R group.|We compared the site-level average number of interim counseling sessions between treatment groups.||8.2|-2.8|0.29
74020085|NCT02939131|147592201|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.03|TWO_SIDED|95.0|0.02|0.38|||t-test, 2 sided||A positive difference indicates higher site-level averages in the COMB-R group.|The average score for all participants at each site was computed. These site-level averages were compared across treatment groups.||0.38|0.02|0.03
74020086|NCT02939131|147592202|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.69|TWO_SIDED|95.0|-0.43|0.29|||t-test, 2 sided||A positive difference would indicate the site-level averages were higher in the COMB-R group compared to the ESC group and vice versa|The average of scores for all participants' clinicians at each site was computed and these site-level averages were compared across treatments.||0.29|-0.43|0.69
74020087|NCT02939131|147592203|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.004|TWO_SIDED|95.0|0.26|1.03|||t-test, 2 sided||A positive difference would indicate site-level averages were higher for the COMB-R group than the ESC group and vice versa.|The average scores for all participants' prescribing clinicians at each site were computed and these site-level averages were compared across treatment groups.||1.03|0.26|0.004
74020088|NCT02939131|147592204|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|0.16||||0.98|TWO_SIDED|95.0|-14.04|14.36|||t-test, 2 sided||We subtract group mean for ESC from group mean for COMB-R. The group means are the means of the site-level percentages of participants with events.|This is the analysis of new Grade 3+ signs/symptoms through week 24. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||14.36|-14.04|0.98
74020089|NCT02939131|147592204|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|2.57||||0.6|TWO_SIDED|95.0|-7.85|12.98|||t-test, 2 sided||We subtracted the group mean for the ESC group from that of the COMB-R group. The group mean is the mean of the site-specific percentages of participants with events.|This is the analysis of new Grade 3+ diagnoses through week 24.The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||12.98|-7.85|0.60
73836181|NCT03300336|147221379|SUPERIORITY||Mean Difference (Net)|1.46||||0.25|TWO_SIDED|95.0|-1.05|3.96||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention: 6 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.96|-1.05|0.25
74020090|NCT02939131|147592204|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.The group mean is the mean of the site-specific percentages of participants with events as defined above.|Mean Difference (Final Values)|4.4||||0.17|TWO_SIDED|95.0|-2.21|11.02|||t-test, 2 sided||The ESC group mean percent of participants reporting a trigger event was subtracted from the COMB-R group mean.|This is the analysis of the triggering events (psychiatric hospitalizations or suicide attempts) through week 24. A participant is counted once if they had reported any such event prior to the upper bound of the week 24 window. The percent of participants at each site with at least one such event were computed.The average of these site-level percents was calculated for each treatment arm. These averages were compared.||11.02|-2.21|0.17
74080458|NCT00841542|147713488|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.22||||||90.0|93.87|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.88|93.87|
73958729|NCT01544062|147452873|SUPERIORITY_OR_OTHER|||||||0.492|TWO_SIDED||||||Fisher Exact|||||||0.492
73958730|NCT01544062|147452874|SUPERIORITY_OR_OTHER|||||||0.455|TWO_SIDED||||||Fisher Exact|||||||0.455
73958731|NCT01544062|147452875|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
74020091|NCT02939131|147592205|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.98|TWO_SIDED|95.0|-13.85|14.13|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new Grade 3+ signs/symptoms through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||14.13|-13.85|0.98
74020092|NCT02939131|147592205|SUPERIORITY||Mean Difference (Final Values)|5.64||||0.4|TWO_SIDED|95.0|-8.6|19.89|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new Grade 3+ diagnoses through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||19.89|-8.60|0.40
74020093|NCT02939131|147592205|SUPERIORITY||Mean Difference (Final Values)|3.01||||0.44|TWO_SIDED|95.0|-5.27|11.29|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new trigger events through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||11.29|-5.27|0.44
74020094|NCT02631538|147592261|OTHER||Least square (LS) mean difference|-2.86|STANDARD_ERROR_OF_MEAN|1.758|||TWO_SIDED|95.0|-6.38|0.67|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.67|-6.38|
74020095|NCT02631538|147592261|OTHER||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.382|||TWO_SIDED|95.0|-3.75|1.78|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.78|-3.75|
74020096|NCT02631538|147592261|OTHER||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.442|||TWO_SIDED|95.0|-3.52|2.26|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.26|-3.52|
74020097|NCT02631538|147592261|OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|1.732|||TWO_SIDED|95.0|-5.34|1.6|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.60|-5.34|
74020098|NCT02631538|147592261|OTHER||LS mean difference|0.35|STANDARD_ERROR_OF_MEAN|1.422|||TWO_SIDED|95.0|-2.5|3.2|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.20|-2.50|
74020099|NCT02631538|147592261|OTHER||LS mean difference|-2.45|STANDARD_ERROR_OF_MEAN|1.607|||TWO_SIDED|95.0|-5.67|0.77|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.77|-5.67|
74020100|NCT02631538|147592261|OTHER||LS mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.265|||TWO_SIDED|95.0|-3.99|1.08|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.08|-3.99|
74020101|NCT02631538|147592261|OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.305|||TWO_SIDED|95.0|-2.68|2.55|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.55|-2.68|
73958732|NCT04495634|147452879|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.|||||<|0.0001|||||||ANOVA|||||||<0.0001
74020102|NCT02631538|147592261|OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|1.584|||TWO_SIDED|95.0|-4.17|2.18|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.18|-4.17|
74020103|NCT02631538|147592261|OTHER||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|-1.2|3.97|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.97|-1.20|
74020104|NCT02631538|147592261|OTHER||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|1.845|||TWO_SIDED|95.0|-4.66|2.73|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.73|-4.66|
74020105|NCT02631538|147592261|OTHER||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|1.449|||TWO_SIDED|95.0|-2.76|3.05|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.05|-2.76|
74020106|NCT02631538|147592261|OTHER||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|1.498|||TWO_SIDED|95.0|-2.15|3.86|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.86|-2.15|
74020107|NCT02631538|147592261|OTHER||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|1.817|||TWO_SIDED|95.0|-4.76|2.53|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.53|-4.76|
74020108|NCT02631538|147592261|OTHER||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.476|||TWO_SIDED|95.0|-2.25|3.66|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.66|-2.25|
74020109|NCT02631538|147592261|OTHER||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-5.95|0.34|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.34|-5.95|
74020110|NCT02631538|147592261|OTHER||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|1.237|||TWO_SIDED|95.0|-3.39|1.56|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.56|-3.39|
74020111|NCT02631538|147592261|OTHER||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|1.275|||TWO_SIDED|95.0|-3.91|1.2|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.20|-3.91|
74020112|NCT02631538|147592261|OTHER||LS mean difference|-1.89|STANDARD_ERROR_OF_MEAN|1.548|||TWO_SIDED|95.0|-4.99|1.21|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.21|-4.99|
74020113|NCT02631538|147592261|OTHER||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|1.261|||TWO_SIDED|95.0|-2.97|2.08|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.08|-2.97|
74020114|NCT02631538|147592261|OTHER||LS mean difference|-3.99|STANDARD_ERROR_OF_MEAN|1.699|||TWO_SIDED|95.0|-7.39|-0.58|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||-0.58|-7.39|
74020115|NCT02631538|147592261|OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|1.336|||TWO_SIDED|95.0|-4.54|0.81|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.81|-4.54|
74020116|NCT02631538|147592261|OTHER||LS mean difference|-1.35|STANDARD_ERROR_OF_MEAN|1.379|||TWO_SIDED|95.0|-4.12|1.41|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.41|-4.12|
74020117|NCT02631538|147592261|OTHER||LS mean difference|-2.12|STANDARD_ERROR_OF_MEAN|1.674|||TWO_SIDED|95.0|-5.47|1.23|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.23|-5.47|
74020118|NCT02631538|147592261|OTHER||LS mean difference|0.51|STANDARD_ERROR_OF_MEAN|1.362|||TWO_SIDED|95.0|-2.21|3.24|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.24|-2.21|
74020119|NCT00849667|147592275|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4513|TWO_SIDED|95.0|0.81|1.21|||Log Rank|One-sided log rank test||||1.21|0.81|0.4513
74020120|NCT00849667|147592275|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0761|TWO_SIDED|95.0|0.7|1.06|||Log Rank|One-sided log rank test||||1.06|0.70|0.0761
74080459|NCT03214588|147713493|SUPERIORITY||Least Squares Mean Difference|-0.00054|STANDARD_ERROR_OF_MEAN|0.000746|>|0.999|TWO_SIDED|90.0|-0.00179|0.0007||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.00070|-0.00179|>0.999
74080460|NCT03214588|147713493|SUPERIORITY||Least Squares Mean Difference|-0.00069|STANDARD_ERROR_OF_MEAN|0.000616|>|0.999|TWO_SIDED|90.0|-0.00172|0.00033||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.00033|-0.00172|>0.999
73958733|NCT04495634|147452880|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.41|||||||ANOVA|||||||0.41
73958734|NCT04495634|147452881|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.0001|||||||ANOVA|||||||0.0001
73958735|NCT04495634|147452882|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.0001|||||||ANOVA|||||||0.0001
74020121|NCT00849667|147592276|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4823|TWO_SIDED|95.0|0.78|1.27|||Log Rank|One-sided log rank test||||1.27|0.78|0.4823
74080461|NCT03214588|147713494|SUPERIORITY||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.782||0.135|TWO_SIDED|90.0|-2.18|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.44|-2.18|0.135
74080462|NCT03214588|147713494|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.64||0.818|TWO_SIDED|90.0|-0.48|1.66||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.66|-0.48|0.818
74020122|NCT00849667|147592276|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1616|TWO_SIDED|95.0|0.68|1.13|||Log Rank|One-sided log rank test||||1.13|0.68|0.1616
74020123|NCT00849667|147592277|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.2938|TWO_SIDED|95.0|0.72|1.21|||Log Rank|One-sided log-rank test||||1.21|0.72|0.2938
74020124|NCT00849667|147592277|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0318|TWO_SIDED|95.0|0.58|1.02|||Log Rank|One-sided log-rank test||||1.02|0.58|0.0318
74020125|NCT00849667|147592278|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5636|TWO_SIDED|95.0|0.85|1.21|||Log Rank|One-sided log-rank test||||1.21|0.85|0.5636
74020126|NCT00849667|147592278|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.156|TWO_SIDED|95.0|0.76|1.09|||Log Rank|One-sided log-rank test||||1.09|0.76|0.1560
74020127|NCT00849667|147592280|SUPERIORITY||Difference in percentage|1.8||||0.6864|TWO_SIDED|95.0|-5.4|9.0|||Cochran-Mantel-Haenszel|||||9.0|-5.4|0.6864
74020128|NCT00849667|147592280|SUPERIORITY||Difference in percentage|2.4||||0.4923|TWO_SIDED|95.0|-4.8|9.6|||Cochran-Mantel-Haenszel|||||9.6|-4.8|0.4923
74020129|NCT00849667|147592283|SUPERIORITY||Difference in percentage|-0.4||||0.8106|TWO_SIDED|95.0|-4.9|4.1|||Cochran-Mantel-Haenszel|||50% serological response||4.1|-4.9|0.8106
74020130|NCT00849667|147592283|SUPERIORITY||Difference in percentage|5.1||||0.0064|TWO_SIDED|95.0|1.4|8.8|||Cochran-Mantel-Haenszel|||50% serological response||8.8|1.4|0.0064
74020131|NCT00849667|147592283|SUPERIORITY||Difference in percentage|4.1||||0.3005|TWO_SIDED|95.0|-2.0|10.2|||Cochran-Mantel-Haenszel|||75% serological response||10.2|-2.0|0.3005
74020132|NCT00849667|147592283|SUPERIORITY||Difference in percentage|3.7||||0.2445|TWO_SIDED|95.0|-2.5|9.9|||Cochran-Mantel-Haenszel|||75% serological response||9.9|-2.5|0.2445
74020133|NCT00849667|147592283|SUPERIORITY||Difference in percentage|5.3||||0.2797|TWO_SIDED|95.0|-2.8|13.4|||Cochran-Mantel-Haenszel|||Serologic response leading to normalization||13.4|-2.8|0.2797
74020134|NCT00849667|147592283|SUPERIORITY||Difference in percentage|4.9||||0.2136|TWO_SIDED|95.0|-3.2|13.0|||Cochran-Mantel-Haenszel|||Serologic response leading to normalization||13.0|-3.2|0.2136
74020135|NCT02086331|147592299|OTHER||||||||||||||||||Intraclass correlation of repeated measures - 0.96, p=0.08|||
74020136|NCT00510276|147592306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.82||||0.005|TWO_SIDED|95.0|1.44|8.2||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||8.20|1.44|0.005
74020137|NCT00510276|147592307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.006|TWO_SIDED|95.0|1.68|10.12||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||10.12|1.68|0.006
74020138|NCT00510276|147592308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.73||||0.018|TWO_SIDED|95.0|1.0|10.46||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||10.46|1.00|0.018
74020139|NCT00510276|147592309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36||||0.034|TWO_SIDED|95.0|0.33|8.39||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 psychological health subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||8.39|0.33|0.034
74020140|NCT00510276|147592310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.074|TWO_SIDED|95.0|-0.33|7.12||A gate-keeper strategy was applied to adjust for multiple tests.|ANCOVA|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 life outlook subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||7.12|-0.33|0.074
74020141|NCT00510276|147592311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|||<|0.001|TWO_SIDED|95.0|-0.63|-0.24|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in CGI-ADHD-S score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.24|-0.63|<0.001
74020142|NCT00510276|147592312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04|||<|0.001|TWO_SIDED|95.0|-5.94|-2.15|||Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in CAARS-S:SV score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-2.15|-5.94|<0.001
74020143|NCT00510276|147592313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.02|TWO_SIDED|95.0|-0.45|-0.04|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in PGI-I scores at 12-week endpoint between atomoxetine and placebo treatment groups.||-0.04|-0.45|0.020
74020144|NCT00510276|147592314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.282|TWO_SIDED|95.0|-1.19|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in MADRS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.35|-1.19|0.282
74020145|NCT00510276|147592315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.556|TWO_SIDED|95.0|-2.21|1.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in BAI score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||1.19|-2.21|0.556
74080463|NCT03214588|147713494|SUPERIORITY||Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.77||0.591|TWO_SIDED|90.0|-1.11|1.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.47|-1.11|0.591
74080464|NCT03214588|147713494|SUPERIORITY||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.643||0.713|TWO_SIDED|90.0|-0.71|1.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.44|-0.71|0.713
74080465|NCT03214588|147713494|SUPERIORITY||Least Squares Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.822||0.616|TWO_SIDED|90.0|-1.13|1.62||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.62|-1.13|0.616
74080466|NCT03214588|147713494|SUPERIORITY||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.679||0.708|TWO_SIDED|90.0|-0.76|1.51||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.51|-0.76|0.708
74020146|NCT00510276|147592316|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Pearson's Correlation Coefficient|||Tested was the null hypothesis that AAQOL-29 total score and CAARS-Inv:SV total score are not correlated.||||<0.001
74020147|NCT00510276|147592317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.198|TWO_SIDED|95.0|-0.39|0.08|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of alcohol score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.08|-0.39|0.198
74020148|NCT00510276|147592318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.825|TWO_SIDED|95.0|-0.33|0.26|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of caffeine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.26|-0.33|0.825
74020149|NCT00510276|147592320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.233|TWO_SIDED|95.0|-0.53|2.17|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of nicotine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||2.17|-0.53|0.233
74020150|NCT00510276|147592321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.676|TWO_SIDED|95.0|-0.24|0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of marijuana score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.37|-0.24|0.676
74020151|NCT00510276|147592322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.382|TWO_SIDED|95.0|-1.0|0.39|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Fagerstorm Test for Nicotine Dependence score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.39|-1.00|0.382
74020152|NCT00510276|147592323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.656|TWO_SIDED|95.0|-1.24|0.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in SASS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.78|-1.24|0.656
74020153|NCT00510276|147592324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.201|TWO_SIDED|95.0|-4.08|0.86|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Self-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.86|-4.08|0.201
74020154|NCT00510276|147592325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.06|||<|0.001|TWO_SIDED|95.0|-7.39|-2.72|||Mixed Models Analysis|Adjusted for treatment, investigator, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction.||Tested was the null hypothesis that there is no difference in CAARS-Inv:SV score changes from baseline to 12-week endpoint between the atomoxetine group and the placebo group. With approximately 220 patients per arm, assuming a 68% completion rate and an estimated effect size of atomoxetine over placebo of 0.35, using a 5% significance level, the analysis was expected to have 90% power to detect a difference between atomoxetine and placebo at week 12.||-2.72|-7.39|<0.001
74020155|NCT00510276|147592326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.933|TWO_SIDED|95.0|-16.41|17.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Other-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||17.63|-16.41|0.933
74020156|NCT00510276|147592327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.95||||0.007|TWO_SIDED|95.0|-5.09|-0.81|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Behavioral regulation score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.81|-5.09|0.007
74020157|NCT00510276|147592328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.219|TWO_SIDED|95.0|-1.5|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A emotional control section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.35|-1.50|0.219
74020158|NCT00510276|147592329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.58||||0.002|TWO_SIDED|95.0|-12.37|-2.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A GEC section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-2.78|-12.37|0.002
74020159|NCT00510276|147592330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.644|TWO_SIDED|95.0|-0.47|0.29|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inconsistency section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.29|-0.47|0.644
74080467|NCT03214588|147713495|SUPERIORITY||Least Squares Mean Difference|-0.00039|STANDARD_ERROR_OF_MEAN|0.000604||0.741|TWO_SIDED|90.0|-0.0014|0.00062||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.00062|-0.00140|0.741
74020160|NCT00510276|147592331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.097|TWO_SIDED|95.0|-0.02|0.25|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEFS-A infrequency score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.25|-0.02|0.097
74020161|NCT00510276|147592332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.002|TWO_SIDED|95.0|-1.57|-0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inhibit Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.37|-1.57|0.002
74020162|NCT00510276|147592333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.044|TWO_SIDED|95.0|-1.33|-0.02|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Initiate section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.02|-1.33|0.044
74020163|NCT00510276|147592334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.49||||0.003|TWO_SIDED|95.0|-7.43|-1.55|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Metacognition section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-1.55|-7.43|0.003
74080468|NCT03214588|147713495|SUPERIORITY||Least Squares Mean Difference|-0.00093|STANDARD_ERROR_OF_MEAN|0.000505||0.964|TWO_SIDED|90.0|-0.00177|-0.00008||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||-0.00008|-0.00177|0.964
74080469|NCT03214588|147713495|SUPERIORITY||Least Squares Mean Difference|-0.00014|STANDARD_ERROR_OF_MEAN|0.000772||0.573|TWO_SIDED|90.0|-0.00143|0.00115||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.00115|-0.00143|0.573
74020164|NCT00510276|147592335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.456|TWO_SIDED|95.0|-0.51|0.23|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A negativity section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.23|-0.51|0.456
74020165|NCT00510276|147592336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.051|TWO_SIDED|95.0|-1.31|0.0|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Organization of Materials section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.00|-1.31|0.051
74020166|NCT00510276|147592337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.002|TWO_SIDED|95.0|-2.19|-0.47|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Plan/Organize section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.47|-2.19|0.002
74020167|NCT00510276|147592338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.045|TWO_SIDED|95.0|-1.04|-0.01|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A SHIFT section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.01|-1.04|0.045
74020168|NCT00510276|147592339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.001|TWO_SIDED|95.0|-1.35|-0.32|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Self Monitor Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.32|-1.35|0.001
74020169|NCT00510276|147592340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.008|TWO_SIDED|95.0|-1.23|-0.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Task Monitor section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.19|-1.23|0.008
74020170|NCT00510276|147592341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.98|-0.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Working Memory section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.63|-1.98|<0.001
74020171|NCT00510276|147592342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.065|TWO_SIDED|95.0|-1.42|0.04|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in ESS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.04|-1.42|0.065
74020172|NCT00510276|147592343|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Cochran-Mantel-Haenszel|Tested was smoking status across treatment.||Tested was the null hypothesis that smoking status is not a predictor of response to atomoxetine treatment compared with placebo||||0.788
74020173|NCT00510276|147592344|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||Tested was smoking status across treatment.|Cochran-Mantel-Haenszel|||Tested was the null hypothesis that smoking status is not a predictor of strong response to atomoxetine treatment compared with placebo||||0.482
74020174|NCT03486392|147592345|SUPERIORITY||Difference of least square (LS) Means|-6.75|STANDARD_ERROR_OF_MEAN|1.056|<|0.001|TWO_SIDED|95.0|-9.31|-4.19|||Dunnett's method|||||-4.19|-9.31|< 0.001
74020175|NCT03486392|147592345|SUPERIORITY||Difference of LS Means|-8.07|STANDARD_ERROR_OF_MEAN|0.921|<|0.001|TWO_SIDED|95.0|-10.31|-5.84|||Dunnett's method|||||-5.84|-10.31|< 0.001
74020176|NCT03486392|147592345|SUPERIORITY||Difference of LS Means|-10.04|STANDARD_ERROR_OF_MEAN|0.934|<|0.001|TWO_SIDED|95.0|-12.31|-7.78|||Dunnett's method|||||-7.78|-12.31|< 0.001
74020177|NCT03486392|147592345|SUPERIORITY||Difference of LS Means|-5.78|STANDARD_ERROR_OF_MEAN|0.91|<|0.001|TWO_SIDED|95.0|-7.99|-3.57|||Dunnett's method|||||-3.57|-7.99|< 0.001
74020178|NCT00565617|147592436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
74020179|NCT02022826|147592438|OTHER||percentage of agreement|76.0||||0.0052|TWO_SIDED|95.0|69.0|83.0|||McNemar|||||83|69|0.0052
74020180|NCT02022826|147592439|OTHER||precentage of agreement|92.0||||1|TWO_SIDED|95.0|87.0|96.0|||McNemar|||||96|87|1.00
74020181|NCT01078805|147592440|SUPERIORITY_OR_OTHER|||||||0.0177||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0177
74020182|NCT01078805|147592440|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0019
74020183|NCT01078805|147592440|SUPERIORITY_OR_OTHER|||||||0.0143||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0143
74020184|NCT01078805|147592441|SUPERIORITY_OR_OTHER|||||||0.0689||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0689
74020185|NCT01078805|147592441|SUPERIORITY_OR_OTHER|||||||0.0412||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0412
74020186|NCT01078805|147592441|SUPERIORITY_OR_OTHER|||||||0.0631||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0631
74020187|NCT01078805|147592442|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74020188|NCT01078805|147592443|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74020189|NCT00880750|147592474|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.47, 3.47).|Mean Difference (Final Values)|-1.35|||||TWO_SIDED|90.0|-2.18|-0.51|||Mixed Models Analysis|||||-0.51|-2.18|
74020190|NCT00880750|147592475|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.40, 3.40).|Mean Difference (Final Values)|-1.98|||||TWO_SIDED|90.0|-3.17|-0.8|||Mixed Models Analysis|||||-0.80|-3.17|
74020191|NCT00880750|147592476|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric LS means|1.34||||||90.0|1.26|1.42|||Mixed Models Analysis|After application of the log transformation AUC 0-48 was analysed using a mixed effect linear model.||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.||1.42|1.26|
74020192|NCT00880750|147592477|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric LS means|1.26||||||90.0|1.2|1.33|||Mixed Models Analysis|After application of the log transformation Cmax was analysed using a mixed effect linear model.||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.||1.33|1.20|
74020193|NCT00880750|147592478|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.01||||||90.0|0.0|0.5|||Wilcoxon (Hodges-Lehmann)|The median difference and 90% CI for the median difference was then calculated based on Hodges-Lehmann estimate for Wilcoxon's Signed Rank test||||0.50|0.00|
74020194|NCT02265913|147592479|EQUIVALENCE|provides 85% of success|Equivalence ratio|98.0|||||TWO_SIDED|90.0|92.0|105.0|||Fieller's method|||||105|92|
74020195|NCT00670007|147592484|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.279|||=|0.752|TWO_SIDED|95.0|-1.089|0.53||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% confidence interval \[CI\] being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC + FRC combined) was a linear random regression model with country, inspiration state, time since Day 1 \[CE1226\_4001\], and treatment-by time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.530|-1.089|= 0.752
74020196|NCT00670007|147592484|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.371|||=|0.823|TWO_SIDED|95.0|-1.159|0.417||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC) was a linear random regression model with country, time since Day 1 \[CE1226\_4001\], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.417|-1.159|= 0.823
74020197|NCT00670007|147592484|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.176|||=|0.648|TWO_SIDED|95.0|-1.09|0.738||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for FRC) was a linear random regression model with country, time since Day 1 \[CE1226\_4001\], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.738|-1.09|= 0.648
74020198|NCT00670007|147592485|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.53||||0.526|TWO_SIDED|95.0|-2.179|1.12||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.||1.120|-2.179|0.526
74080470|NCT03214588|147713495|SUPERIORITY||Least Squares Mean Difference|-0.00044|STANDARD_ERROR_OF_MEAN|0.000646||0.749|TWO_SIDED|90.0|-0.00152|0.00064||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.00064|-0.00152|0.749
73836182|NCT03300336|147221380|SUPERIORITY||Odds Ratio (OR)|1.16||||0.59|TWO_SIDED|95.0|0.68|1.99||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 3 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||1.99|0.68|0.59
74020199|NCT00670007|147592485|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.486||||0.558|TWO_SIDED|95.0|-2.126|1.154||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||1.154|-2.126|0.558
74020200|NCT00670007|147592485|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.019||||0.984|TWO_SIDED|95.0|-1.858|1.895||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||1.895|-1.858|0.984
74020201|NCT00670007|147592486|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.294||||0.883|TWO_SIDED|95.0|-3.645|4.233||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.||4.233|-3.645|0.883
74020202|NCT00670007|147592486|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.151||||0.941|TWO_SIDED|95.0|-4.172|3.87||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||3.870|-4.172|0.941
74020203|NCT00670007|147592486|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.787||||0.404|TWO_SIDED|95.0|-2.44|6.014||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||6.014|-2.440|0.404
74020204|NCT00618722|147592496|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.043|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.0|-0.9|0.043
74020205|NCT00618722|147592496|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.05|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.0|-0.8|0.050
74020206|NCT00618722|147592496|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.249|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.2|-0.7|0.249
74020207|NCT00618722|147592497|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.003|TWO_SIDED|95.0|0.7|3.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||3.1|0.7|0.003
74020208|NCT00618722|147592497|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.03|TWO_SIDED|95.0|0.1|2.6|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||2.6|0.1|0.030
74020209|NCT00618722|147592497|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.012|TWO_SIDED|95.0|0.4|2.8|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||2.8|0.4|0.012
74020210|NCT00618722|147592498|SUPERIORITY_OR_OTHER||Difference from Placebo|38.9||||0.015|TWO_SIDED|95.0|12.6|65.2|||Fisher Exact|||||65.2|12.6|0.015
74020211|NCT00618722|147592498|SUPERIORITY_OR_OTHER||Difference from Placebo|28.9||||0.096|TWO_SIDED|95.0|0.4|57.5|||Fisher Exact|||||57.5|0.4|0.096
74020212|NCT00618722|147592498|SUPERIORITY_OR_OTHER||Difference from Placebo|44.7||||0.003|TWO_SIDED|95.0|20.6|68.8|||Fisher Exact|||||68.8|20.6|0.003
74020213|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.078|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.6|0.0|0.078
74020214|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.781|TWO_SIDED|95.0|-0.3|0.4|||Repeated easures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.3|0.781
74080471|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.154||0.571|TWO_SIDED|90.0|-0.23|0.29||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils||0.29|-0.23|0.571
74020215|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.5|-0.1|0.146
74020216|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.076|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.6|0.0|0.076
74020217|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.975|TWO_SIDED|95.0|-0.3|0.3|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.3|-0.3|0.975
74020218|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.183|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.5|-0.1|0.183
74020219|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.017|TWO_SIDED|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.7|0.1|0.017
74020220|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.022|TWO_SIDED|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.7|0.1|0.022
74020221|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.081|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.6|0.0|0.081
74020222|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.51|TWO_SIDED|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.2|0.510
74020223|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.33|TWO_SIDED|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.2|-0.5|0.330
74020224|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.72|TWO_SIDED|95.0|-0.3|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.3|0.720
74020225|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.205|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.5|-0.1|0.205
74020226|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.41|TWO_SIDED|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.2|-0.5|0.410
74020227|NCT00618722|147592499|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.436|TWO_SIDED|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.4|-0.2|0.436
73958736|NCT03612804|147452883|SUPERIORITY||Odds Ratio (OR)|1.05||||0.83|TWO_SIDED|95.0|0.67|1.64||P-value not adjusted for multiple comparisons. A priori threshold for statistical significance was 0.05.|Regression, Logistic|Logistic regression model with random intercept for provider and main effect term for study site.|Proactive care arm represents numerator of odds ratio, unstructured care arm represents denominator of odds ratio.|||1.64|0.67|0.83
73958737|NCT03105128|147452891|SUPERIORITY||Adjusted Risk Difference|20.7|||<|0.001|TWO_SIDED|95.0|12.4|29.0|||Cochran-Mantel-Haenszel|||||29.0|12.4|<0.001
74020228|NCT00618722|147592500|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.762|TWO_SIDED|95.0|-9.1|12.3|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||12.3|-9.1|0.762
74020229|NCT00618722|147592500|SUPERIORITY_OR_OTHER||LS mean Difference|5.2||||0.248|TWO_SIDED|95.0|-3.8|14.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||14.2|-3.8|0.248
74020230|NCT00618722|147592500|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3||||0.061|TWO_SIDED|95.0|-0.4|19.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||19.1|-0.4|0.061
74020231|NCT00624221|147592502|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 40 subjects was estimated based on having 80% power to determine greater than 10% difference in cell loss between groups with estimated standard deviation of 17 and estimated correlation of 0.5.||||||0.1|TWO_SIDED|95.0|||||paired difference t-test|||||||0.10
74020232|NCT00200057|147592505|SUPERIORITY_OR_OTHER||Proportion|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.81||No multiplicity adjustments were made for the primary outcome analysis. Two-tailed p-values were considered statistically significant if they were less than 0.05.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.81|0.64|<0.0001
74020233|NCT00200057|147592506|SUPERIORITY_OR_OTHER||Proportion|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.81||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.81|0.64|<0.0001
74020234|NCT00200057|147592507|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
74020235|NCT00200057|147592508|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
74020236|NCT00200057|147592509|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
73958738|NCT03105128|147452891|SUPERIORITY||Adjusted Risk Difference|16.7|||<|0.001|TWO_SIDED|95.0|8.5|24.9|||Cochran-Mantel-Haenszel|||||24.9|8.5|<0.001
73958739|NCT03105128|147452892|SUPERIORITY||Adjusted Risk Difference|28.3|||<|0.001|TWO_SIDED|95.0|21.2|35.4|||Cochran-Mantel-Haenszel|||||35.4|21.2|<0.001
74020237|NCT00200057|147592510|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
73958740|NCT03105128|147452892|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.6|27.1|||Cochran-Mantel-Haenszel|||||27.1|13.6|<0.001
74020238|NCT00200057|147592511|SUPERIORITY_OR_OTHER||Proportion|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.79||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.79|0.62|<0.0001
74020239|NCT00778830|147592512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3176|||||TWO_SIDED|95.0|0.8078|2.1491||||||||2.1491|0.8078|
74020240|NCT00132041|147592518|OTHER||Success rate|0.18|||||TWO_SIDED|95.0|0.091|0.317|||||logistic regression model without correcting for the clustering effect|logistic regression was used to estimate the success rate||0.317|0.091|
73958741|NCT03105128|147452893|SUPERIORITY||Adjusted Risk Difference|21.9|||<|0.001|TWO_SIDED|95.0|13.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|13.8|<0.001
73958742|NCT03105128|147452893|SUPERIORITY||Adjusted Risk Difference|18.8|||<|0.001|TWO_SIDED|95.0|10.8|26.8|||Cochran-Mantel-Haenszel|||||26.8|10.8|<0.001
73958743|NCT03105128|147452894|SUPERIORITY||Adjusted Risk Difference|28.3|||<|0.001|TWO_SIDED|95.0|21.2|35.4|||Cochran-Mantel-Haenszel|||||35.4|21.2|<0.001
73958744|NCT03105128|147452894|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.6|27.1|||Cochran-Mantel-Haenszel|||||27.1|13.6|<0.001
73958745|NCT03105128|147452895|SUPERIORITY||Risk Difference (RD)|21.9|||<|0.001|TWO_SIDED|95.0|13.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|13.8|<0.001
73958746|NCT03105128|147452895|SUPERIORITY||Adjusted Risk Difference|18.8|||<|0.001|TWO_SIDED|95.0|10.8|26.8|||Cochran-Mantel-Haenszel|||||26.8|10.8|<0.001
74020241|NCT00132041|147592518|OTHER||Success rate|0.19|||||TWO_SIDED|95.0|0.136|0.252||||||logistic regression model after specifying site as cluster (using GEE approach).||0.252|0.136|
74020242|NCT00132041|147592519|OTHER||Success rate|0.18|||||TWO_SIDED|95.0|0.091|0.317|||||logistic regression model without correcting for the clustering effect|logistic regression was used to estimate the success rate||0.317|0.091|
74029771|NCT03151148|147614039|SUPERIORITY||Geometric mean ratio (GMR)|0.93||||0.957|TWO_SIDED|95.0|0.062|13.875|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.875|0.062|0.957
73958747|NCT03105128|147452896|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|7.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|7.2|<0.001
73958748|NCT03105128|147452896|SUPERIORITY||Adjusted Risk Difference|11.2||||0.007|TWO_SIDED|95.0|3.1|19.2|||Cochran-Mantel-Haenszel|||||19.2|3.1|0.007
73958749|NCT03105128|147452897|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|14.2|31.9|||Cochran-Mantel-Haenszel|||||31.9|14.2|<0.001
74020243|NCT00132041|147592519|OTHER||Slope|-3.7913||||0.0004|TWO_SIDED|95.0|-5.9056|-1.6769|||Generlaized estimating equations|Multivariate logistic model. P-value for number of RFA sessions dichotomized 1: more than 1; using the latter as the reference.|This estimate is for the effect of a single RFA sessions (v multiple sessions) in the multivariate model response:18 mo success/failure; covariates: tumor size,repeated RFA, local tumor recurrence, remote tumor occurrence, and age and gender.|multivariate logistic regression model was fit using GEEs to correct for site clustering effects, in which, the response variable was success/failure at 18 months and the covariates were tumor size, whether or not a patient received repeated RFA, whether or not a local tumor recurrence occurred, whether or not a remote tumor occurrence occurred, and two common confounding factors - age and gender||-1.6769|-5.9056|0.0004
74020244|NCT00132041|147592520|OTHER||GEE|-0.9101||||0.0221|TWO_SIDED|95.0|-1.6894|-0.1308|||Generlaized Estimating Equations|multivariate GEE model using logistic link|Estimation parameter is for tumor size when controlling for other covariates.|Effect of tumor size in the multivariate model with response:18 mo success/failure; covariates: tumor size,repeated RFA, local tumor recurrence, remote tumor occurrence, and age and gender.||-0.1308|-1.6894|0.0221
74020245|NCT00132041|147592522|OTHER||Mean Difference (Final Values)|-0.458|STANDARD_ERROR_OF_MEAN|0.2496||0.06|TWO_SIDED|||||assuming unequal variance (Satterthwaite p)|t-test, 2 sided||Difference represents the size of tumors that do no recur minus those that do.|the mean tumor size in the two groups, recurred and non recurred tumors, will be compared using a t-test assuming H0: recur=non-recurr||||0.06
74020246|NCT00132041|147592524|OTHER||Sensitivity|0.083|||||TWO_SIDED|95.0|0.0|0.38|||||Twelve tumors were detected in the liver specimens, but only one of those was identified by the CT central readers|||0.38|0.00|
74020247|NCT00132041|147592524|OTHER||Specificity|0.75|||||TWO_SIDED|95.0|0.194|0.994|||||The central CT readers correctly identified three out of the four patients without pathologic evidence of tumor|Specificity||0.994|0.194|
74020248|NCT00132041|147592526|OTHER|McNemar's Test to compare success rates after assuming transplants as successes versus after assuming transplants as failures.||||||0.0001|||||||McNemar|||||||0.0001
74020249|NCT05197803|147592527|SUPERIORITY||Mean Difference (Final Values)|3.32||||0.0001|ONE_SIDED||||||t-test, 1 sided|||The study compared the results between the unaided condition vs. aided condition (BTE)||||0.0001
74020250|NCT05197803|147592527|SUPERIORITY||Mean Difference (Final Values)|3.57||||0.0001|ONE_SIDED||||||t-test, 1 sided|||The study compared the results between the unaided condition vs. aided condition (RIC)||||0.0001
74080472|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.126||0.963|TWO_SIDED|90.0|0.02|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils||0.44|0.02|0.963
73958750|NCT03105128|147452897|SUPERIORITY||Adjusted Risk Difference|27.7|||<|0.001|TWO_SIDED|95.0|19.0|36.4|||Cochran-Mantel-Haenszel|||||36.4|19.0|<0.001
73958751|NCT03105128|147452898|SUPERIORITY||Adjusted Risk Difference|5.2|||<|0.001|TWO_SIDED|95.0|3.2|7.2|||Cochran-Mantel-Haenszel|||||7.2|3.2|<0.001
73958752|NCT03105128|147452898|SUPERIORITY||Adjusted Risk Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||Cochran-Mantel-Haenszel|||||6.1|2.1|<0.001
74020251|NCT00464204|147592598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-331.0|STANDARD_DEVIATION|1033.0||0.0185|TWO_SIDED|95.0|-640.0|-21.0||One-sided t-test assuming unequal variances (as variances were significantly different between treatment groups).No multiple comparisons were made. A priori threshold for statistical significance for the confirmatory analysis on FAS: 0.025 one-sided.|t-test, 1 sided||Considered difference: Voluven® minus NaCl 0.9 %|"Null-hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization in patients treated with Voluven® is higher than or equal to this amount in patients treated with NaCl.~Alternative hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization is lower in patients treated with Voluven® than in patients treated with NaCl."||-21|-640|0.0185
73958753|NCT03105128|147452899|SUPERIORITY||Adjusted Risk Difference|7.6||||0.015|TWO_SIDED|95.0|1.5|13.7|||Cochran-Mantel-Haenszel|||||13.7|1.5|0.015
73958754|NCT03105128|147452899|SUPERIORITY||Adjusted Risk Difference|8.4||||0.007|TWO_SIDED|95.0|2.3|14.6|||Cochran-Mantel-Haenszel|||||14.6|2.3|0.007
73958755|NCT03105128|147452900|SUPERIORITY||Adjusted Risk Difference|24.5|||<|0.001|TWO_SIDED|95.0|18.5|30.5|||Cochran-Mantel-Haenszel|||||30.5|18.5|<0.001
73958756|NCT03105128|147452900|SUPERIORITY||Adjusted Risk Difference|17.3|||<|0.001|TWO_SIDED|95.0|11.8|22.9|||Cochran-Mantel-Haenszel|||||22.9|11.8|<0.001
73958757|NCT03105128|147452901|SUPERIORITY||Adjusted Risk Difference|24.2|||<|0.001|TWO_SIDED|95.0|15.7|32.7|||Cochran-Mantel-Haenszel|||||32.7|15.7|<0.001
73958758|NCT03105128|147452901|SUPERIORITY||Adjusted Risk Difference|23.6|||<|0.001|TWO_SIDED|95.0|15.1|32.1|||Cochran-Mantel-Haenszel|||||32.1|15.1|<0.001
73958759|NCT03105128|147452902|SUPERIORITY||Adjusted Risk Difference|21.2|||<|0.001|TWO_SIDED|95.0|12.4|30.0|||Cochran-Mantel-Haenszel|||||30.0|12.4|<0.001
73958760|NCT03105128|147452902|SUPERIORITY||Adjusted Risk Difference|19.0|||<|0.001|TWO_SIDED|95.0|10.1|27.8|||Cochran-Mantel-Haenszel|||||27.8|10.1|<0.001
73958761|NCT03105128|147452903|SUPERIORITY||Adjusted Risk Difference|15.1|||<|0.001|TWO_SIDED|95.0|9.0|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.0|<0.001
73958762|NCT03105128|147452903|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.4|<0.001
73958763|NCT03105128|147452904|SUPERIORITY||Adjusted Risk Difference|14.9||||0.001|TWO_SIDED|95.0|6.2|23.5|||Cochran-Mantel-Haenszel|||||23.5|6.2|0.001
73958764|NCT03105128|147452904|SUPERIORITY||Adjusted Risk Difference|11.8||||0.007|TWO_SIDED|95.0|3.2|20.3|||Cochran-Mantel-Haenszel|||||20.3|3.2|0.007
74020252|NCT02649634|147592629|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05.|Mixed Models Analysis|||Linear mixed modelling (LMM) was used||||>.05
74020253|NCT02649634|147592630|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
74020254|NCT02649634|147592631|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.||||||0.65|||||||t-test, 2 sided|||Treatment adherence was analyzed via an independent sample t-test comparing the groups on mean number of TrymGym sessions missed.||||.65
74020255|NCT02649634|147592632|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
74020256|NCT02649634|147592633|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
73958765|NCT03105128|147452905|SUPERIORITY||Adjusted Risk Difference|13.7|||<|0.001|TWO_SIDED|95.0|7.9|19.5|||Cochran-Mantel-Haenszel|||||19.5|7.9|<0.001
74020257|NCT02649634|147592634|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
74020258|NCT02649634|147592635|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
74020259|NCT02649634|147592636|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
73958766|NCT03105128|147452905|SUPERIORITY||Adjusted Risk Difference|9.1||||0.001|TWO_SIDED|95.0|3.7|14.5|||Cochran-Mantel-Haenszel|||||14.5|3.7|0.001
74020260|NCT02649634|147592637|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
74020261|NCT02649634|147592638|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
73958767|NCT03105128|147452906|SUPERIORITY||Adjusted Risk Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|12.2|<0.001
73958768|NCT03105128|147452906|SUPERIORITY||Adjusted Risk Difference|21.6|||<|0.001|TWO_SIDED|95.0|12.8|30.4|||Cochran-Mantel-Haenszel|||||30.4|12.8|<0.001
73958769|NCT03105128|147452907|SUPERIORITY||Adjusted Risk Difference|14.6||||0.022|TWO_SIDED|95.0|2.1|27.0|||Cochran-Mantel-Haenszel|||||27.0|2.1|0.022
73958770|NCT03105128|147452907|SUPERIORITY||Adjusted Risk Difference|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.3|||Cochran-Mantel-Haenszel|||||36.3|11.1|<0.001
74020262|NCT02649634|147592639|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
74020263|NCT02649634|147592640|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
74020264|NCT02649634|147592641|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
74020265|NCT02649634|147592642|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
74020266|NCT02649634|147592643|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
74020267|NCT02649634|147592644|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
74020268|NCT02649634|147592645|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.||||>.05
74080473|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.165||0.515|TWO_SIDED|90.0|-0.27|0.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils||0.28|-0.27|0.515
74080474|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.138||0.986|TWO_SIDED|90.0|0.08|0.54||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils||0.54|0.08|0.986
73958771|NCT03105128|147452908|SUPERIORITY||Risk Difference (RD)|-8.7|||<|0.001|TWO_SIDED|95.0|-13.9|-3.5|||Chi-squared|||||-3.5|-13.9|<0.001
74020269|NCT02649634|147592646|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.||||>.05
74020270|NCT02649634|147592647|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.||||>.05
74020271|NCT02649634|147592648|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.||||>.05
73958772|NCT03105128|147452908|SUPERIORITY||Risk Difference (RD)|-10.2|||<|0.001|TWO_SIDED|95.0|-15.2|-5.2|||Chi-squared|||||-5.2|-15.2|<0.001
73958773|NCT03105128|147452909|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-28.6|39.7|||Chi-squared|||||39.7|-28.6|1.00
74020272|NCT02649634|147592649|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales||||>.05
74020273|NCT02649634|147592650|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales||||>.05
74020274|NCT02649634|147592651|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales||||>.05
74020275|NCT02649634|147592652|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales||||>.05
74020276|NCT02649634|147592653|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales||||>.05
74020277|NCT02649634|147592654|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales||||>.05
74020278|NCT01486199|147592686|EQUIVALENCE|alpha=0.05||||||0.002|||||||t-test, 2 sided|||Comparing absorptive clearance in CF children vs adult controls||||0.002
74080475|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.162||0.718|TWO_SIDED|90.0|-0.18|0.37||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils||0.37|-0.18|0.718
73958774|NCT03105128|147452909|SUPERIORITY||Risk Difference (RD)|6.9||||1|TWO_SIDED|25.0|-25.7|39.6|||Chi-squared|||||39.6|-25.7|1.000
73958775|NCT03105128|147452910|SUPERIORITY||Adjusted Risk Difference|20.7|||<|0.001|TWO_SIDED|95.0|12.4|29.0|||Cochran-Mantel-Haenszel|||||29.0|12.4|<0.001
73958776|NCT03105128|147452910|SUPERIORITY||Adjusted Risk Difference|16.7|||<|0.001|TWO_SIDED|95.0|8.5|24.9|||Cochran-Mantel-Haenszel|||||24.9|8.5|<0.001
74020279|NCT01486199|147592687|EQUIVALENCE|alpha = 0.05||||||0.2|||||||t-test, 2 sided|||Comparison of mucociliary clearance in CF children compared to healthy adults||||0.20
74020280|NCT01486199|147592688|EQUIVALENCE|alpha=0.05||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Comparing absorptive clearance at t=0 vs t=2 years in pediatric CF subjects||||0.24
74020281|NCT01486199|147592689|EQUIVALENCE|alpha=0.05||||||0.87|||||||Wilcoxon (Mann-Whitney)|||Comparing mucociliary clearance at t=0 and t=2yrs in pediatric CF subjects||||0.87
74020282|NCT02211261|147592715|OTHER||Percentage of Test relative to Reference|17.66|||||TWO_SIDED|90.0|8.44|36.95|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||36.95|8.44|
74020283|NCT02211261|147592715|OTHER||Percentage of Test relative to Reference|32.73|||||TWO_SIDED|90.0|21.64|49.51|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||49.51|21.64|
74020284|NCT02211261|147592715|OTHER||Percentage of Test relative to Reference|35.02|||||TWO_SIDED|90.0|23.6|51.95|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||51.95|23.60|
73958777|NCT03105128|147452911|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|7.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|7.2|<0.001
74020285|NCT02211261|147592715|OTHER||Percentage of Test relative to Reference|53.18|||||TWO_SIDED|90.0|36.36|77.78|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||77.78|36.36|
73958778|NCT03105128|147452911|SUPERIORITY||Adjusted Risk Difference|11.2||||0.007|TWO_SIDED|95.0|3.1|19.2|||Cochran-Mantel-Haenszel|||||19.2|3.1|0.007
73958779|NCT03105128|147452912|SUPERIORITY||Adjusted Risk Difference|11.5|||<|0.001|TWO_SIDED|95.0|5.4|17.5|||Cochran-Mantel-Haenszel|||||17.5|5.4|<0.001
74020286|NCT02211261|147592717|OTHER||Percentage of Test relative to Reference|7.32|||||TWO_SIDED|90.0|4.7|11.4|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||11.40|4.70|
74020287|NCT02211261|147592717|OTHER||Percentage of Test relative to Reference|32.19|||||TWO_SIDED|90.0|20.67|50.12|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||50.12|20.67|
74020288|NCT02211261|147592717|OTHER||Percentage of Test relative to Reference|34.43|||||TWO_SIDED|90.0|22.57|52.52|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||52.52|22.57|
74020289|NCT02211261|147592717|OTHER||Percentage of Test relative to Reference|51.47|||||TWO_SIDED|90.0|34.26|77.31|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||77.31|34.26|
73958780|NCT03105128|147452912|SUPERIORITY||Adjusted Risk Difference|11.7|||<|0.001|TWO_SIDED|95.0|5.7|17.8|||Cochran-Mantel-Haenszel|||||17.8|5.7|<0.001
74020290|NCT03183128|147592767|SUPERIORITY||Risk Ratio (RR)|0.32|||<|0.001|TWO_SIDED|95.0|0.18|0.58||P-value presented for both hypothesis tests: H0: RR≥1 and H0: RR≥0.833.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|||0.58|0.18|<0.001
74020291|NCT03183128|147592768|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.19|0.67||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 4||0.67|0.19|<0.001
74020292|NCT03183128|147592768|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.001|TWO_SIDED|95.0|0.24|0.65||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 12||0.65|0.24|<0.001
74020293|NCT03183128|147592768|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.3|0.73||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 24||0.73|0.30|<0.001
74020294|NCT01171612|147592771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.086||||0.479|TWO_SIDED|95.0|0.513|2.299|||Chi-squared|||Reference group were patients who maintained antiplatelet drugs (aspirin and/or clopidogrel) during the 4 days before surgery||2.299|0.513|0.479
74080476|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.133||0.986|TWO_SIDED|90.0|0.08|0.52||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils||0.52|0.08|0.986
74080477|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.148||0.153|TWO_SIDED|90.0|-0.4|0.09||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing||0.09|-0.40|0.153
74080478|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.119||0.861|TWO_SIDED|90.0|-0.07|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing||0.33|-0.07|0.861
74080479|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.443|TWO_SIDED|90.0|-0.22|0.18||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing||0.18|-0.22|0.443
74080480|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.359|TWO_SIDED|90.0|-0.2|0.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing||0.13|-0.20|0.359
74080481|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.157||0.268|TWO_SIDED|90.0|-0.36|0.17||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing||0.17|-0.36|0.268
73958781|NCT03105128|147452913|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|14.2|31.9|||Cochran-Mantel-Haenszel|||||31.9|14.2|<0.001
74020295|NCT01171612|147592771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.638||||0.479|TWO_SIDED|95.0|0.733|3.662|||Chi-squared|||||3.662|0.733|0.479
74020296|NCT02440581|147592787|OTHER|T-tests||||||0.443|||||||t-test, 2 sided|||||||.443
74020297|NCT02440581|147592788|OTHER|T-tests||||||0.49|||||||t-test, 2 sided|||||||.490
74020298|NCT02440581|147592789|OTHER|T-tests|||||<|0.001|||||||t-test, 2 sided|||||||<.001
74020299|NCT02440581|147592790|OTHER|T-Tests||||||0.083|||||||t-test, 2 sided|||||||.083
74020300|NCT02440581|147592791|OTHER|T-tests||||||0.283|||||||t-test, 2 sided|||||||.283
74020301|NCT03430986|147592792|SUPERIORITY||Least Squares (LS) Mean Difference|2.037|STANDARD_ERROR_OF_MEAN|0.1578|<|0.0001|TWO_SIDED|95.0|1.726|2.349|||MMRM|MMRM included treatment, timepoint, treatment-by-timepoint interaction as fixed effect using an unstructured covariance matrix.||||2.349|1.726|<0.0001
74020302|NCT03430986|147592793|SUPERIORITY||Percentage difference|68.4|||<|0.0001|TWO_SIDED|95.0|50.0|82.4|||Fisher Exact|2-sided test comparing responder rate between treatment group and control group.||||82.4|50.0|<0.0001
73958782|NCT03105128|147452913|SUPERIORITY||Adjusted Risk Difference|27.7|||<|0.001|TWO_SIDED|95.0|19.0|36.4|||Cochran-Mantel-Haenszel|||||36.4|19.0|<0.001
73958783|NCT03105128|147452914|SUPERIORITY||LS Mean Difference|5.2|||<|0.001|TWO_SIDED|95.0|3.2|7.2|||Mixed-Effect Model Repeat Measurement|||||7.2|3.2|<0.001
73958784|NCT03105128|147452914|SUPERIORITY||LS Mean Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||Mixed-Effect Model Repeat Measurement|||||6.1|2.1|<0.001
74080482|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.129||0.411|TWO_SIDED|90.0|-0.24|0.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing||0.19|-0.24|0.411
74080483|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.151||0.358|TWO_SIDED|90.0|-0.31|0.2||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene||0.20|-0.31|0.358
74080484|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.123||0.946|TWO_SIDED|90.0|0.0|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene||0.41|0.00|0.946
74080485|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.193||0.505|TWO_SIDED|90.0|-0.32|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene||0.33|-0.32|0.505
74080486|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.158||0.658|TWO_SIDED|90.0|-0.2|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene||0.33|-0.20|0.658
73958785|NCT03105128|147452915|SUPERIORITY||LS Mean Difference|20.7|||<|0.001|TWO_SIDED|95.0|14.3|27.1|||Mixed-Effect Model Repeat Measurement|||||27.1|14.3|<0.001
73958786|NCT03105128|147452915|SUPERIORITY||LS Mean Difference|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8|||Mixed-Effect Model Repeat Measurement|||||25.8|13.1|<0.001
73958787|NCT03105128|147452916|SUPERIORITY||Adjusted Risk Difference|23.2|||<|0.001|TWO_SIDED|95.0|16.8|29.6|||Cochran-Mantel-Haenszel|||||29.6|16.8|<0.001
73958788|NCT03105128|147452916|SUPERIORITY||Adjusted Risk Difference|15.2|||<|0.001|TWO_SIDED|95.0|9.3|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.3|<0.001
73958789|NCT03105128|147452917|SUPERIORITY||Adjusted Risk Difference|15.1|||<|0.001|TWO_SIDED|95.0|9.0|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.0|<0.001
73958790|NCT03105128|147452917|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.4|<0.001
74080487|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.184||0.649|TWO_SIDED|90.0|-0.24|0.38||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene||0.38|-0.24|0.649
74080488|NCT03214588|147713496|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.151||0.661|TWO_SIDED|90.0|-0.19|0.32||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene||0.32|-0.19|0.661
74080489|NCT03214588|147713497|SUPERIORITY||Least Squares Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|1.078||0.992|TWO_SIDED|90.0|0.86|4.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.47|0.86|0.992
73958791|NCT03105128|147452918|SUPERIORITY||Adjusted Risk Difference|14.9||||0.001|TWO_SIDED|95.0|6.2|23.5|||Cochran-Mantel-Haenszel|||||23.5|6.2|0.001
73958792|NCT03105128|147452918|SUPERIORITY||Adjusted Risk Difference|11.8||||0.007|TWO_SIDED|95.0|3.2|20.3|||Cochran-Mantel-Haenszel|||||20.3|3.2|0.007
73958793|NCT03105128|147452919|SUPERIORITY||Adjusted Risk Difference|13.7|||<|0.001|TWO_SIDED|95.0|7.9|19.5|||Cochran-Mantel-Haenszel|||||19.5|7.9|<0.001
73958794|NCT03105128|147452919|SUPERIORITY||Adjusted Risk Difference|9.1||||0.001|TWO_SIDED|95.0|3.7|14.5|||Cochran-Mantel-Haenszel|||||14.5|3.7|0.001
73958795|NCT03105128|147452920|SUPERIORITY||Adjusted Risk Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|12.2|<0.001
73958796|NCT03105128|147452920|SUPERIORITY||Adjusted Risk Difference|21.6|||<|0.001|TWO_SIDED|95.0|12.8|30.4|||Cochran-Mantel-Haenszel|||||30.4|12.8|<0.001
73958797|NCT03105128|147452921|SUPERIORITY||Adjusted Risk Difference|14.6||||0.022|TWO_SIDED|95.0|2.1|27.0|||Cochran-Mantel-Haenszel|||||27.0|2.1|0.022
73958798|NCT03105128|147452921|SUPERIORITY||Adjusted Risk Difference|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.3|||Cochran-Mantel-Haenszel|||||36.3|11.1|<0.001
73958799|NCT03105128|147452922|SUPERIORITY||LS Mean Difference|-8.7|||<|0.001|TWO_SIDED|95.0|-13.9|-3.5|||Mixed-Effect Model Repeat Measurement|||||-3.5|-13.9|<0.001
74080490|NCT03214588|147713497|SUPERIORITY||Least Squares Mean Difference|2.78|STANDARD_ERROR_OF_MEAN|0.892||0.999|TWO_SIDED|90.0|1.29|4.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.28|1.29|0.999
74080491|NCT03214588|147713497|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.338||0.616|TWO_SIDED|90.0|-1.84|2.64||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.64|-1.84|0.616
74080492|NCT03214588|147713497|SUPERIORITY||Least Squares Mean Difference|1.06|STANDARD_ERROR_OF_MEAN|1.131||0.823|TWO_SIDED|90.0|-0.83|2.95||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.95|-0.83|0.823
74080493|NCT03214588|147713497|SUPERIORITY||Least Squares Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|1.266||0.942|TWO_SIDED|90.0|-0.1|4.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||4.13|-0.10|0.942
74080494|NCT03214588|147713497|SUPERIORITY||Least Squares Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|1.053||0.975|TWO_SIDED|90.0|0.35|3.87||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||3.87|0.35|0.975
74080495|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|-0.15|0.29||||||Change at Week 2, Bulbar||0.29|-0.15|
74080496|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.12|0.25||||||Change at Week 2, Bulbar||0.25|-0.12|
74080497|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|90.0|-0.3|0.11||||||Change at Week 7, Bulbar||0.11|-0.30|
74080498|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.02|0.33||||||Change at Week 7, Bulbar||0.33|-0.02|
74080499|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.19|0.28||||||Change at Week 12, Bulbar||0.28|-0.19|
74080500|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|90.0|0.0|0.4||||||Change at Week 12, Bulbar||0.40|0.00|
74080501|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|1.99|STANDARD_ERROR_OF_MEAN|0.689|||TWO_SIDED|90.0|0.83|3.14||||||Change at Week 2, Upper Limb Coordination||3.14|0.83|
74080502|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.571|||TWO_SIDED|90.0|0.06|1.97||||||Change at Week 2, Upper Limb Coordination||1.97|0.06|
74080503|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.882|||TWO_SIDED|90.0|-0.4|2.55||||||Change at Week 7, Upper Limb Coordination||2.55|-0.40|
74080504|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.743|||TWO_SIDED|90.0|-1.06|1.43||||||Change at Week 7, Upper Limb Coordination||1.43|-1.06|
74080505|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|1.016|||TWO_SIDED|90.0|-0.48|2.91||||||Change at Week 12, Upper Limb Coordination||2.91|-0.48|
74080506|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-0.87|1.94||||||Change at Week 12, Upper Limb Coordination||1.94|-0.87|
74080507|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.482|||TWO_SIDED|90.0|-0.41|1.2||||||Change at Week 2, Lower Limb Coordination||1.20|-0.41|
74080508|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|90.0|0.12|1.45||||||Change at Week 2, Lower Limb Coordination||1.45|0.12|
74080509|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.837|||TWO_SIDED|90.0|-1.44|1.36||||||Change at Week 7, Lower Limb Coordination||1.36|-1.44|
74080510|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.707|||TWO_SIDED|90.0|-1.01|1.36||||||Change at Week 7, Lower Limb Coordination||1.36|-1.01|
74080511|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|0.755|||TWO_SIDED|90.0|-0.27|2.25||||||Change at Week 12, Lower Limb Coordination||2.25|-0.27|
74080512|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.95|STANDARD_ERROR_OF_MEAN|0.626|||TWO_SIDED|90.0|-0.09|2.0||||||Change at Week 12, Lower Limb Coordination||2.00|-0.09|
74080513|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-0.8|1.3||||||Change at Week 2, Upright Stability||1.3|-0.8|
74080514|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|0.1|1.9||||||Change at Week 2, Upright Stability||1.9|0.1|
74080515|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.3|0.2||||||Change at Week 7, Upright Stability||0.2|-1.3|
74080516|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|0.0|1.2||||||Change at Week 7, Upright Stability||1.2|0.0|
74080517|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|90.0|-1.2|0.7||||||Change at Week 12, Upright Stability||0.7|-1.2|
74080518|NCT03214588|147713498|SUPERIORITY||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.3|1.3||||||Change at Week 12, Upright Stability||1.3|-0.3|
74080519|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.084|||TWO_SIDED|90.0|-0.13|0.15||||||Change at Week 2, Cough||0.15|-0.13|
74080520|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.069|||TWO_SIDED|90.0|-0.11|0.12||||||Change at Week 2, Cough||0.12|-0.11|
74080521|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.105|||TWO_SIDED|90.0|-0.24|0.11||||||Change at Week 7, Cough||0.11|-0.24|
73958800|NCT03105128|147452922|SUPERIORITY||LS Mean Difference|-10.2|||<|0.001|TWO_SIDED|95.0|-15.2|-5.2|||Mixed-Effect Model Repeat Measurement|||||-5.2|-15.2|<0.001
73958801|NCT03105128|147452923|SUPERIORITY||LS Mean Difference|5.6||||1|TWO_SIDED|95.0|-28.6|39.7|||Mixed-Effect Model Repeat Measurement|||||39.7|-28.6|1.000
73836183|NCT03300336|147221381|SUPERIORITY||Mean Difference (Net)|0.99||||0.47|TWO_SIDED|95.0|-1.71|3.69||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 11 out of 227 Missing data due to item nonresponse in intervention: 20 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.69|-1.71|0.47
73958802|NCT03105128|147452923|SUPERIORITY||LS Mean Difference|6.9||||1|TWO_SIDED|95.0|-25.7|39.6|||Mixed-Effect Model Repeat Measurement|||||39.6|-25.7|1.000
73958803|NCT03105128|147452924|SUPERIORITY||LS Mean Difference|-9.586||||0.024|TWO_SIDED|95.0|-17.89|-1.282|||Mixed-Effect Model Repeat Measurement|||||-1.282|-17.890|0.024
74080522|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.088|||TWO_SIDED|90.0|-0.05|0.25||||||Change at Week 7, Cough||0.25|-0.05|
74080523|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|-0.11|0.25||||||Change at Week 12, Cough||0.25|-0.11|
74080524|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|90.0|-0.03|0.26||||||Change at Week 12, Cough||0.26|-0.03|
74080525|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.09|0.25||||||Change at Week 2, Speech||0.25|-0.09|
74080526|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|90.0|-0.04|0.24||||||Change at Week 2, Speech||0.24|-0.04|
74080527|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|90.0|-0.16|0.08||||||Change at Week 7, Speech||0.08|-0.16|
74080528|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.03|0.17||||||Change at Week 7, Speech||0.17|-0.03|
74080529|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.095|||TWO_SIDED|90.0|-0.16|0.16||||||Change at Week 12, Speech||0.16|-0.16|
74080530|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|90.0|-0.04|0.22||||||Change at Week 12, Speech||0.22|-0.04|
74080531|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.131|||TWO_SIDED|90.0|-0.14|0.29||||||Change at Week 2, Right Finger to Finger Test||0.29|-0.14|
74080532|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|90.0|-0.22|0.14||||||Change at Week 2, Right Finger to Finger Test||0.14|-0.22|
74080533|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|90.0|-0.13|0.28||||||Change at Week 7, Right Finger to Finger Test||0.28|-0.13|
74080534|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.103|||TWO_SIDED|90.0|-0.24|0.11||||||Change at Week 7, Right Finger to Finger Test||0.11|-0.24|
74080535|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.126|||TWO_SIDED|90.0|-0.3|0.12||||||Change at Week 12, Right Finger to Finger Test||0.12|-0.30|
74080536|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.32|0.03||||||Change at Week 12, Right Finger to Finger Test||0.03|-0.32|
74080537|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|90.0|-0.15|0.33||||||Change at Week 2, Left Finger to Finger Test||0.33|-0.15|
74080538|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|90.0|-0.16|0.23||||||Change at Week 2, Left Finger to Finger Test||0.23|-0.16|
74080539|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|90.0|-0.18|0.23||||||Change at Week 7, Left Finger to Finger Test||0.23|-0.18|
74080540|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.15|0.2||||||Change at Week 7, Left Finger to Finger Test||0.20|-0.15|
74080541|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.158|||TWO_SIDED|90.0|-0.17|0.36||||||Change at Week 12, Left Finger to Finger Test||0.36|-0.17|
74080542|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.3|0.13||||||Change at Week 12, Left Finger to Finger Test||0.13|-0.30|
74080543|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.04|0.53||||||Change at Week 2, Right Nose to Finger Test||0.53|0.04|
74080544|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|90.0|-0.06|0.33||||||Change at Week 2, Right Nose to Finger Test||0.33|-0.06|
73958804|NCT03105128|147452924|SUPERIORITY||LS Mean Difference|-12.141||||0.004|TWO_SIDED|95.0|-20.39|-3.892|||Mixed-Effect Model Repeat Measurement|||||-3.892|-20.390|0.004
73958805|NCT03105128|147452925|SUPERIORITY||LS Mean Difference|2.913|||<|0.001|TWO_SIDED|95.0|1.512|4.313|||Mixed-Effect Model Repeat Measurement|||||4.313|1.512|<0.001
74080545|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.174|||TWO_SIDED|90.0|-0.22|0.37||||||Change at Week 7, Right Nose to Finger Test||0.37|-0.22|
74080546|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|90.0|-0.32|0.16||||||Change at Week 7, Right Nose to Finger Test||0.16|-0.32|
74080547|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.166|||TWO_SIDED|90.0|-0.43|0.12||||||Change at Week 12, Right Nose to Finger Test||0.12|-0.43|
74080548|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|90.0|-0.23|0.23||||||Change at Week 12, Right Nose to Finger Test||0.23|-0.23|
74080549|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.14|0.4||||||Change at Week 2, Left Nose to Finger Test||0.40|-0.14|
74080550|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|-0.12|0.33||||||Change at Week 2, Left Nose to Finger Test||0.33|-0.12|
74080551|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.157|||TWO_SIDED|90.0|-0.09|0.43||||||Change at Week 7, Left Nose to Finger Test||0.43|-0.09|
73958806|NCT03105128|147452925|SUPERIORITY||LS Mean Difference|3.275|||<|0.001|TWO_SIDED|95.0|1.877|4.672|||Mixed-Effect Model Repeat Measurement|||||4.672|1.877|<0.001
74080552|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|90.0|-0.36|0.09||||||Change at Week 7, Left Nose to Finger Test||0.09|-0.36|
74080553|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.169|||TWO_SIDED|90.0|-0.29|0.27||||||Change at Week 12, Left Nose to Finger Test||0.27|-0.29|
74080554|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.21|0.27||||||Change at Week 12, Left Nose to Finger Test||0.27|-0.21|
74080555|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.33|0.26||||||Change at Week 2, Right Dysmetria Test||0.26|-0.33|
74080556|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|-0.12|0.36||||||Change at Week 2, Right Dysmetria Test||0.36|-0.12|
74080557|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|90.0|-0.25|0.48||||||Change at Week 7, Right Dysmetria Test||0.48|-0.25|
74080558|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.14|0.47||||||Change at Week 7, Right Dysmetria Test||0.47|-0.14|
74080559|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|90.0|-0.26|0.48||||||Change at Week 12, Right Dysmetria Test||0.48|-0.26|
74080560|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.36|0.25||||||Change at Week 12, Right Dysmetria Test||0.25|-0.36|
74080561|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.185|||TWO_SIDED|90.0|-0.02|0.6||||||Change at Week 2, Left Dysmetria Test||0.60|-0.02|
74080562|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|90.0|-0.1|0.41||||||Change at Week 2, Left Dysmetria Test||0.41|-0.10|
74080563|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|90.0|-0.63|0.13||||||Change at Week 7, Left Dysmetria Test||0.13|-0.63|
74080564|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.192|||TWO_SIDED|90.0|-0.47|0.18||||||Change at Week 7, Left Dysmetria Test||0.18|-0.47|
74080565|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|90.0|-0.37|0.48||||||Change at Week 12, Left Dysmetria Test||0.48|-0.37|
74080566|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.11|0.58||||||Change at Week 12, Left Dysmetria Test||0.58|-0.11|
73930691|NCT03238911|147391292|SUPERIORITY||Mean Difference (Final Values)|15.75|||<|0.0001|TWO_SIDED|95.0|8.83|22.67|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.67|8.83|<0.0001
74080567|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.06|0.51||||||Change at Week 2, RAM of Right Hands||0.51|-0.06|
74080568|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.12|0.35||||||Change at Week 2, RAM of Right Hands||0.35|-0.12|
74080569|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.204|||TWO_SIDED|90.0|-0.41|0.28||||||Change at Week 7, RAM of Right Hands||0.28|-0.41|
74080570|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.172|||TWO_SIDED|90.0|-0.29|0.29||||||Change at Week 7, RAM of Right Hands||0.29|-0.29|
74080571|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.187|||TWO_SIDED|90.0|-0.12|0.51||||||Change at Week 12, RAM of Right Hands||0.51|-0.12|
74080572|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.156|||TWO_SIDED|90.0|-0.31|0.21||||||Change at Week 12, RAM of Right Hands||0.21|-0.31|
74080573|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.15|0.32||||||Change at Week 2, RAM of Left Hands||0.32|-0.15|
74080574|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|90.0|-0.12|0.27||||||Change at Week 2, RAM of Left Hands||0.27|-0.12|
74080575|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.27|0.43||||||Change at Week 7, RAM of Left Hands||0.43|-0.27|
74080576|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.17|0.42||||||Change at Week 7, RAM of Left Hands||0.42|-0.17|
74080577|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|90.0|0.04|0.58||||||Change at Week 12, RAM of Left Hand||0.58|0.04|
74080578|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|90.0|-0.01|0.43||||||Change at Week 12, RAM of Left Hand||0.43|-0.01|
74080579|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.201|||TWO_SIDED|90.0|0.1|0.77||||||Change at Week 2, Right Finger Taps||0.77|0.10|
74080580|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|90.0|-0.12|0.44||||||Change at Week 2, Right Finger Taps||0.44|-0.12|
74080581|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.227|||TWO_SIDED|90.0|-0.16|0.6||||||Change at Week 7, Right Finger Taps||0.60|-0.16|
74080582|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|90.0|-0.33|0.31||||||Change at Week 7, Right Finger Taps||0.31|-0.33|
74080583|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.233|||TWO_SIDED|90.0|-0.22|0.56||||||Change at Week 12, Right Finger Taps||0.56|-0.22|
74080584|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.194|||TWO_SIDED|90.0|-0.39|0.26||||||Change at Week 12, Right Finger Taps||0.26|-0.39|
74080585|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.223|||TWO_SIDED|90.0|0.12|0.87||||||Change at Week 2, Left Finger Taps||0.87|0.12|
74080586|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.25|0.36||||||Change at Week 2, Left Finger Taps||0.36|-0.25|
74080587|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.218|||TWO_SIDED|90.0|0.22|0.95||||||Change at Week 7, Left Finger Taps||0.95|0.22|
74080588|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|90.0|-0.15|0.47||||||Change at Week 7, Left Finger Taps||0.47|-0.15|
74080589|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.272|||TWO_SIDED|90.0|0.11|1.02||||||Change at Week 12, Left Finger Taps||1.02|0.11|
74080590|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|90.0|-0.04|0.71||||||Change at Week 12, Left Finger Taps||0.71|-0.04|
73836184|NCT03300336|147221382|SUPERIORITY||Mean Difference (Net)|-0.07||||0.94|TWO_SIDED|95.0|-1.76|1.62||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention group: 7 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||1.62|-1.76|0.94
73836185|NCT00378560|147221387|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|87.6|||||TWO_SIDED|95.0|59.2|97.6|||||Binomial probability conditional on the fixed number of events.|||97.6|59.2|
74080591|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|90.0|-0.12|0.53||||||Change at Week 2, Right Heel Along Shin Slide||0.53|-0.12|
74080592|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.26|0.27||||||Change at Week 2, Right Heel Along Shin Slide||0.27|-0.26|
74080593|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|90.0|-0.56|0.28||||||Change at Week 7, Right Heel Along Shin Slide||0.28|-0.56|
74020303|NCT01583374|147592818|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-4.1||||0.4383|TWO_SIDED|95.0|-14.3|6.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel (CMH) weights|||6.2|-14.3|0.4383
74080594|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|90.0|-0.53|0.19||||||Change at Week 7, Right Heel Along Shin Slide||0.19|-0.53|
74080595|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.12|0.78||||||Change at Week 12,Right Heel Along Shin Slide||0.78|-0.12|
74020304|NCT01583374|147592818|SUPERIORITY||Risk Difference (RD)|-1.7||||0.7427|TWO_SIDED|95.0|-12.0|8.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference in proportions is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||8.5|-12.0|0.7427
74080596|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.226|||TWO_SIDED|90.0|-0.25|0.51||||||Change at Week 12,Right Heel Along Shin Slide||0.51|-0.25|
73836186|NCT00378560|147221388|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73836187|NCT00378560|147221389|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
74020305|NCT01583374|147592819|SUPERIORITY||LS Mean Difference|-0.05||||0.8032|TWO_SIDED|95.0|-0.41|0.32|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.32|-0.41|0.8032
74080597|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|90.0|-0.51|0.18||||||Change at Week 2, Left Heel Along Shin Slide||0.18|-0.51|
74080598|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.166|||TWO_SIDED|90.0|-0.25|0.31||||||Change at Week 2, Left Heel Along Shin Slide||0.31|-0.25|
74080599|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|90.0|-0.68|0.07||||||Change at Week 7, Left Heel Along Shin Slide||0.07|-0.68|
74080600|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.188|||TWO_SIDED|90.0|-0.48|0.15||||||Change at Week 7, Left Heel Along Shin Slide||0.15|-0.48|
73836188|NCT00378560|147221390|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
74020306|NCT01583374|147592819|SUPERIORITY||LS Mean Difference|-0.17||||0.3624|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.19|-0.53|0.3624
74080601|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|90.0|-0.45|0.4||||||Change at Week 12, Left Heel Along Shin Slide||0.40|-0.45|
73836189|NCT00378560|147221391|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73836190|NCT01543503|147221466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.851|||<|0.001|TWO_SIDED|95.0|-1.112|-0.589|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an analysis of covariance (ANCOVA) model with change from baseline in DAS28-ESR at 24 weeks as dependent variable; therapy, site country, and treatment as fixed effects; DAS28-ESR at baseline as covariates.||-0.589|-1.112|<0.001
74080602|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.34|0.36||||||Change at Week 12, Left Heel Along Shin Slide||0.36|-0.34|
74080603|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.187|||TWO_SIDED|90.0|-0.1|0.53||||||Change at Week 2, Right Heel Along Shin Tap||0.53|-0.10|
74080604|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|90.0|0.17|0.69||||||Change at Week 2, Right Heel Along Shin Tap||0.69|0.17|
74080605|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.272|||TWO_SIDED|90.0|-0.72|0.19||||||Change at Week 7, Right Heel Along Shin Tap||0.19|-0.72|
74080606|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|90.0|-0.38|0.39||||||Change at Week 7, Right Heel Along Shin Tap||0.39|-0.38|
74080607|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|90.0|-0.23|0.51||||||Change at Week 12, Right Heel Along Shin Tap||0.51|-0.23|
74080608|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|0.02|0.64||||||Change at Week 12, Right Heel Along Shin Tap||0.64|0.02|
74020307|NCT01583374|147592820|SUPERIORITY||LS Mean Difference|0.03||||0.8618|TWO_SIDED|95.0|-0.33|0.4|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.40|-0.33|0.8618
74020308|NCT01583374|147592820|SUPERIORITY||LS Mean Difference|-0.09||||0.6262|TWO_SIDED|95.0|-0.45|0.27|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.27|-0.45|0.6262
74020309|NCT01583374|147592821|SUPERIORITY||Risk Difference (RD)|2.0||||0.6958|TWO_SIDED|95.0|-8.1|12.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||12.2|-8.1|0.6958
74020310|NCT01583374|147592821|SUPERIORITY||Risk Difference (RD)|4.4||||0.4051|TWO_SIDED|95.0|-5.8|14.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||14.5|-5.8|0.4051
74080609|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.199|||TWO_SIDED|90.0|-0.17|0.5||||||Change at Week 2, Left Heel Along Shin Tap||0.50|-0.17|
74080610|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|90.0|0.06|0.61||||||Change at Week 2, Left Heel Along Shin Tap||0.61|0.06|
74080611|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|90.0|-0.09|0.84||||||Change at Week 7, Left Heel Along Shin Tap||0.84|-0.09|
74080612|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.234|||TWO_SIDED|90.0|-0.19|0.6||||||Change at Week 7, Left Heel Along Shin Tap||0.60|-0.19|
74080613|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.303|||TWO_SIDED|90.0|-0.2|0.82||||||Change at Week 12, Left Heel Along Shin Tap||0.82|-0.20|
73958807|NCT00768651|147452933|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The sample size of 8 was determined to provide a 95% confidence interval expected width of 0.62 for the proportion of subjects who become insulin independent with treatment. Four of eight subjects (50%) would have to achieve insulin independence in order to reject the null hypothesis with 85% power and one sided alpha of 0.025. Statistical significance was set at 5%. Mean values were computed using Student's t-test while medians were compared using Wilcoxon's test.||||< 0.05
74080614|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.17|0.67||||||Change at Week 12, Left Heel Along Shin Tap||0.67|-0.17|
73958808|NCT02124460|147452958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.3928|TWO_SIDED|95.0|-0.08|0.03|||Linear repeated measures|Multiple imputation was used for missing follow-up data.|Health Coaching group compared to Enhanced Primary Care|||0.03|-0.08|0.3928
74080615|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.1|0.5||||||Change at Week 2, Siting Posture||0.5|-0.1|
74020311|NCT01583374|147592822|SUPERIORITY||LS Mean Difference|0.25||||0.5126|TWO_SIDED|95.0|-0.49|0.99|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.99|-0.49|0.5126
74020312|NCT01583374|147592822|SUPERIORITY||LS Mean Difference|0.28||||0.4624|TWO_SIDED|95.0|-0.46|1.01|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.01|-0.46|0.4624
74020313|NCT01583374|147592823|SUPERIORITY||LS Mean Difference|0.29||||0.6997|TWO_SIDED|95.0|-1.18|1.76|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.76|-1.18|0.6997
74080616|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.1|0.4||||||Change at Week 2, Siting Posture||0.4|-0.1|
74080617|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, Siting Posture||0.2|-0.4|
74080618|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.0|0.5||||||Change at Week 7, Siting Posture||0.5|0.0|
74080619|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.5|0.2||||||Change at Week 12, Siting Posture||0.2|-0.5|
74080620|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.2|0.3||||||Change at Week 12, Siting Posture||0.3|-0.2|
74080621|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.4|0.4||||||Change at Week 2, SFA - TTA||0.4|-0.4|
74080622|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.3|0.3||||||Change at Week 2, SFA - TTA||0.3|-0.3|
74080623|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, SFA - TTA||0.2|-0.4|
74080624|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.5|0.1||||||Change at Week 7, SFA - TTA||0.1|-0.5|
74080625|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 12, SFA - TTA||0.4|-0.3|
74080626|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.2|0.4||||||Change at Week 12, SFA - TTA||0.4|-0.2|
74080627|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.1|0.3||||||Change at Week 2, SFA (Eyes Closed) - TTA||0.3|-0.1|
74080628|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFA (Eyes Closed) - TTA||0.1|-0.2|
74080629|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, SFA (Eyes Closed) - TTA||0.2|-0.4|
74080630|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.4|0.1||||||Change at Week 7, SFA (Eyes Closed) - TTA||0.1|-0.4|
74080631|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 12, SFA (Eyes Closed) - TTA||0.4|-0.3|
74080632|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.5|0.1||||||Change at Week 12, SFA (Eyes Closed) - TTA||0.1|-0.5|
74080633|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.8|0.2||||||Change at Week 2, SFT - TTA||0.2|-0.8|
74080634|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|0.0|0.8||||||Change at Week 2, SFT - TTA||0.8|0.0|
73836191|NCT01543503|147221467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|||<|0.001|TWO_SIDED|95.0|-1.204|-0.617|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an ANCOVA model with change from baseline to 12 months in DAS28-ESR as dependent variable; therapy and treatment as fixed effects; DAS28-ESR at baseline as covariates.||-0.617|-1.204|<0.001
74020314|NCT01583374|147592823|SUPERIORITY||LS Mean Difference|-0.04||||0.9587|TWO_SIDED|95.0|-1.5|1.42|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.42|-1.50|0.9587
74020315|NCT01583374|147592824|SUPERIORITY||LS Mean Difference|0.06||||0.3307|TWO_SIDED|95.0|-0.06|0.17|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.17|-0.06|0.3307
74020316|NCT01583374|147592824|SUPERIORITY||LS Mean Difference|0.03||||0.5938|TWO_SIDED|95.0|-0.08|0.14|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.14|-0.08|0.5938
74020317|NCT01265524|147592831|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.014|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.014
74020318|NCT01265524|147592835|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.0002|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.0002
74020319|NCT01265524|147592836|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.072|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.072
74020320|NCT02587338|147592837|SUPERIORITY|||||||0.74|||||||ANOVA|||||||0.74
74020321|NCT02587338|147592838|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||||||0.062
74020322|NCT01506882|147592839|SUPERIORITY_OR_OTHER||Percent|73.8|||||TWO_SIDED|95.0|60.9|84.2||||||"The primary efficacy variable was to be calculated as the proportion p=n/N of subjects (n) staying seizure free for 6 months out of the total number of subjects (N). For this proportion p, an exact 2-sided 95% confidence interval (CI) was computed based on the F distribution.~The hypothesis H0: p=0.4 was to be formally rejected in favor of H1: p\>0.4, if the lower confidence limit for p was greater than 0.4."||84.2|60.9|
74080635|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 7, SFT - TTA||0.4|-0.3|
74080636|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.2|0.7||||||Change at Week 7, SFT - TTA||0.7|0.2|
74080637|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.5|0.2||||||Change at Week 12, SFT - TTA||0.2|-0.5|
74080638|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.0|0.7||||||Change at Week 12, SFT - TTA||0.7|0.0|
74020323|NCT01302808|147592847|OTHER||Maximum Tolerated Dose|8.0|||||TWO_SIDED|||||||||||||
74020324|NCT00821678|147592849|SUPERIORITY_OR_OTHER||Slope|-3.81||||0.002|TWO_SIDED|95.0|-6.19|-1.43|||Mixed Models Analysis|||||-1.43|-6.19|0.002
74080639|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) - TTA||0.1|-0.2|
74080640|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) - TTA||0.1|-0.2|
74080641|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.2||||||Change at Week 7, SFT (Eyes Closed) - TTA||0.2|-0.2|
74080642|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 7, SFT (Eyes Closed) - TTA||0.2|-0.1|
74080643|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.2||||||Change at Week 12, SFT (Eyes Closed) - TTA||0.2|-0.2|
74080644|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.3|0.0||||||Change at Week 12, SFT (Eyes Closed) - TTA||0.0|-0.3|
74080645|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, Tandem Stance - TTA||0.1|-0.2|
74080646|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Stance - TTA||0.1|-0.1|
74080647|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.0||||||Change at Week 7, Tandem Stance - TTA||0.0|-0.2|
74080648|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 7, Tandem Stance - TTA||0.2|-0.1|
74020325|NCT00821678|147592850|SUPERIORITY_OR_OTHER||Slope|-0.25||||0.001|TWO_SIDED|95.0|-0.4|-0.1|||Mixed Models Analysis|||||-0.1|-0.4|0.001
74020326|NCT00821678|147592851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.48|TWO_SIDED|95.0|-0.33|0.7|||t-test, 2 sided|||||0.70|-0.33|0.48
74020327|NCT00821678|147592852|SUPERIORITY_OR_OTHER||Slope|2.67||||0.02|TWO_SIDED|95.0|0.45|4.91|||Mixed Models Analysis|||||4.91|0.45|0.02
74020328|NCT00821678|147592855|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.86||||0.65|TWO_SIDED|95.0|0.46|1.62|||Mixed Models Analysis|||||1.62|0.46|0.65
74020329|NCT00821678|147592856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.9|||<|0.001|TWO_SIDED|95.0|3.2|19.6|||Mixed Models Analysis|||||19.6|3.2|<0.001
74020330|NCT03694392|147592875|OTHER||Hazard Ratio (HR)|0.85|||<|0.05|TWO_SIDED|95.0|0.76|0.94||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.3% (5.9%, 23.8%)|||0.94|0.76|<0.05
74020331|NCT03694392|147592876|OTHER||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.65|1.09||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.9% (-9.2% to 35.2%)|||1.09|0.65|<0.05
74020332|NCT03694392|147592877|OTHER||Hazard Ratio (HR)|0.83|||<|0.05|TWO_SIDED|95.0|0.66|1.06||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 16.7% (-5.6% to 34.4%)|||1.06|0.66|<0.05
73836192|NCT01543503|147221468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.23|||<|0.001|TWO_SIDED|95.0|-15.513|-10.947|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in ESR as a dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.||-10.947|-15.513|<0.001
74020333|NCT03694392|147592878|OTHER||Hazard Ratio (HR)|0.98|||<|0.05|TWO_SIDED|95.0|0.88|1.08||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 2.4% (-8.1% to 11.9%)|||1.08|0.88|<0.05
74020334|NCT03694392|147592879|OTHER||Hazard Ratio (HR)|1.16|||<|0.05|TWO_SIDED|95.0|0.75|1.8|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -15.7% (-79.5% to 25.5%)|||1.80|0.75|<0.05
74020335|NCT03694392|147592880|OTHER||Hazard Ratio (HR)|1.001|||<|0.05|TWO_SIDED|95.0|0.95|1.06|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.0% to 5.4%)|||1.06|0.95|<0.05
74020336|NCT03694392|147592881|OTHER||Hazard Ratio (HR)|1.8|||<|0.05|TWO_SIDED|95.0|-2.2|5.5|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 1.8% (-2.2% to 5.5%)|||5.5|-2.2|<0.05
74020337|NCT03694392|147592882|OTHER||Hazard Ratio (HR)|9.4|||<|0.05|TWO_SIDED|95.0|-5.4|22.1|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 9.4% (-5.4% to 22.1%)|||22.1|-5.4|<0.05
74020338|NCT03694392|147592883|OTHER||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.86|1.02|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 6.2% (-2.2% to 13.9%)|||1.02|0.86|<0.05
74020339|NCT03694392|147592884|OTHER||Hazard Ratio (HR)|1.07|||<|0.05|TWO_SIDED|95.0|0.75|1.52|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -6.9% (-51.6% to 24.6%)|||1.52|0.75|<0.05
74020340|NCT03694392|147592885|OTHER||Hazard Ratio (HR)|0.95|||<|0.05|TWO_SIDED|95.0|0.76|1.12|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 5.2% (-18.8% to 24.4%)|||1.12|0.76|<0.05
74020341|NCT03694392|147592886|OTHER||Hazard Ratio (HR)|0.89|||<|0.05|TWO_SIDED|95.0|0.85|0.93|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.8% (6.6% to 14.7%)|||0.93|0.85|<0.05
74020342|NCT03694392|147592887|OTHER||Hazard Ratio (HR)|1.001|||<|0.05|TWO_SIDED|95.0|0.94|1.06|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.2% to 5.6%)|||1.06|0.94|<0.05
74020343|NCT03694392|147592888|OTHER||Hazard Ratio (HR)|1.46|||<|0.05|TWO_SIDED|95.0|1.06|2.0|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -45.5% (-100.2% to -5.8%)|||2.00|1.06|<0.05
74020344|NCT03694392|147592889|OTHER||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.82|0.99|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.2% (1.4% to 18.2%)|||0.99|0.82|<0.05
74080649|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 12, Tandem Stance - TTA||0.1|-0.2|
74080650|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 12, Tandem Stance - TTA||0.2|-0.1|
73958809|NCT02124460|147452959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.2306|TWO_SIDED|95.0|-0.56|2.33|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care|||2.33|-0.56|0.2306
74020345|NCT03694392|147592890|OTHER||Hazard Ratio (HR)|1.16|||<|0.05|TWO_SIDED|95.0|0.95|1.43|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -16.2% (-43.0% to 5.5%)|||1.43|0.95|<0.05
74020346|NCT03694392|147592891|OTHER||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.76|0.94|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.7% (6.0% to 24.5%)|||0.94|0.76|<0.05
74020347|NCT03694392|147592892|OTHER||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.6|1.34|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.3% (-33.9% to 39.9%)|||1.34|0.60|<0.05
73958810|NCT02124460|147452960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.14|TWO_SIDED|95.0|-0.02|0.16|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care.|||0.16|-0.02|.14
74020348|NCT02591615|147592906|SUPERIORITY|||||||0.2176|||||||Fisher Exact|||||||0.2176
74080651|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk||0.1|-0.1|
74080652|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk||0.1|-0.1|
73958811|NCT02124460|147452961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.0016|TWO_SIDED|95.0|-0.81|-0.19|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||-0.19|-0.81|0.0016
73958812|NCT02124460|147452962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42|||<|0.0001|TWO_SIDED|95.0|0.22|0.62||Multiple imputation used for missing data at follow-up.|Linear repeated measures|||||0.62|0.22|<.0001
73958813|NCT02124460|147452963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.3043|TWO_SIDED|95.0|-0.16|0.53|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.53|-0.16|0.3043
73958814|NCT02124460|147452964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.0113|TWO_SIDED|95.0|0.07|0.56|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.56|0.07|0.0113
74020349|NCT02591615|147592907|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.84|TWO_SIDED|95.0|0.67|1.64|||Log Rank|||||1.64|0.67|0.84
74080653|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 7, Tandem Walk||0.1|-0.2|
74080654|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 7, Tandem Walk||0.1|-0.1|
74080655|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.3|0.0||||||Change at Week 12, Tandem Walk||0.0|-0.3|
74080656|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 12, Tandem Walk||0.1|-0.2|
73836193|NCT01543503|147221468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.648|||<|0.001|TWO_SIDED|95.0|-15.419|-9.876|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in ESR, as the dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.||-9.876|-15.419|<0.001
73958815|NCT02124460|147452965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.0792|TWO_SIDED|95.0|-0.45|0.03|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.03|-0.45|0.0792
73958816|NCT03008915|147452993|OTHER|Paired t-test for participants with measures on both aspirin and placebo.||||||0.692|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between measures on aspirin and placebo.||||0.692
73958817|NCT00712166|147453000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.433|TWO_SIDED|95.0|-2.83|6.44||"The primary endpoint analysis was based on a two-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeper approach was established a priori to control the type 1 error rate, however, the primary endpoint was not met."|ANCOVA|ANCOVA included: treatment, baseline CFQ-R RSS, age group (\<18, \>=18 years). Denominator degrees of freedom computed with Satterthwaite approximation.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~At the 5% significance level (i.e., α = 0.05) using a two-sided significance test, a sample size of 70 participants per treatment group provided at least 90% power to detect a 10 point difference between groups in the mean change from baseline at Day 28 in the CFQ-R RSS score, assuming a common standard deviation (SD) of 17.5."||6.44|-2.83|0.433
74080657|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.2|0.4||||||Change at Week 2, Gait||0.4|-0.2|
74080658|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.1|0.7||||||Change at Week 2, Gait||0.7|0.1|
74020350|NCT02863068|147592915|SUPERIORITY|||||||0.2967||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS for all participants between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for all participants.||||0.2967
74020351|NCT02863068|147592916|SUPERIORITY|||||||0.2818||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS)||||0.2818
74020352|NCT02863068|147592916|SUPERIORITY|||||||1|||||||Fisher Exact|Fisher's exact test was used to test for differences in frequencies between treatment arms||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms||||1.0
74020353|NCT02863068|147592917|SUPERIORITY|||||||0.3754||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS)||||0.3754
74080659|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, Gait||0.2|-0.4|
74080660|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.1|0.6||||||Change at Week 7, Gait||0.6|0.1|
74080661|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 12, Gait||0.2|-0.4|
74080662|NCT03214588|147713499|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|0.0|0.5||||||Change at Week 12, Gait||0.5|0.0|
74080663|NCT03214588|147713500|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.889||0.599|TWO_SIDED|90.0|-1.31|1.76||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.76|-1.31|0.599
73958818|NCT00712166|147453001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.37||||0.133|TWO_SIDED|95.0|-1.04|7.78||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included terms: treatment, baseline CFQ-R RSS, age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 14.||7.78|-1.04|0.133
73958819|NCT00712166|147453002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.965|TWO_SIDED|95.0|-4.56|4.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment, baseline CFQ-R RSS and age group (\<18 years, \>=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 42.||4.76|-4.56|0.965
73958820|NCT00712166|147453003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47||||0.256||95.0|-1.81|6.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included: treatment, baseline CFQ-R Physical Function Domain score and age (\<18, \>=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R physical functioning domain score at Day 28.||6.76|-1.81|0.256
74080664|NCT03214588|147713500|SUPERIORITY||Least Squares Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.625||0.978|TWO_SIDED|90.0|0.26|2.42||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||2.42|0.26|0.978
73958821|NCT00712166|147453004|SUPERIORITY_OR_OTHER||||||>|0.999||0.0||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple usage was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.||||>0.999
73958822|NCT00712166|147453005|SUPERIORITY_OR_OTHER|||||||0.122||||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple hospitalizations was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in proportion of participants hospitalized.||||0.122
73958823|NCT00712166|147453008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.016|TWO_SIDED|95.0|-2.2|-0.23||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline log10 CFU, and age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the log10 CFU at Day 28.||-0.23|-2.20|0.016
73958824|NCT00712166|147453009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.73||||0.021|TWO_SIDED|95.0|0.42|5.04||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model includes treatment, baseline FEV1 % predicted, and age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in % change from baseline in FEV1 % predicted at Day 28.||5.04|0.42|0.021
73958825|NCT01264718|147453015|OTHER|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|6.0|||||TWO_SIDED||||||||The estimated value is the savings per child per year insured.|||||
74020354|NCT02863068|147592919|SUPERIORITY|||||||0.1165||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.1165
74020355|NCT02863068|147592919|SUPERIORITY|||||||0.4583||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.4583
74020356|NCT02863068|147592920|SUPERIORITY|||||||0.068||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.068
73836194|NCT01543503|147221469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.673|||<|0.001|TWO_SIDED|95.0|-10.271|-3.074|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CRP as a dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.||-3.074|-10.271|<0.001
73958826|NCT01264718|147453015|OTHER|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|4.0|||||TWO_SIDED||||||||The estimated value is the savings for each percent increase in children obtaining insurance per year.|||||
73958827|NCT03772964|147453029|SUPERIORITY|Comparisons between samples and sample groups (beta-diversity), were evaluated with ADONIS (aka PERMANOVA) comparisons of differences between sample groups.|R2|0.071435|||<|0.01|TWO_SIDED||||||ADONISBeta Diversity|Comparisons between samples and sample groups (beta-diversity) were evaluated with ADONIS (aka PERMANOVA)|R2 values estimate the amount of variation explained by each variable.|Beta Diversity - Differences between Samples and Sample groups||||<0.01
73958828|NCT03772964|147453030|SUPERIORITY|||||||0.6057|||||||ANOVA|||||||0.6057
73958829|NCT03772964|147453032|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73958830|NCT03772964|147453033|SUPERIORITY|||||||0.69|||||||ANOVA|||||||0.69
74020357|NCT02863068|147592920|SUPERIORITY|||||||0.5||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.5
74020358|NCT02863068|147592920|SUPERIORITY|||||||1|||||||Fisher Exact|Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants on Hydroxyurea (HU).||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants on Hydroxyurea (HU).||||1.0
73836195|NCT01543503|147221469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.116||||0.659|TWO_SIDED|95.0|-6.074|3.842|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CRP as the dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.||3.842|-6.074|0.659
73836196|NCT01543503|147221470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.576||||0.024|TWO_SIDED|95.0|-1.078|-0.075|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SJC as the dependent variable; therapy and treatment as fixed effects; SJC at baseline as the covariate.||-0.075|-1.078|0.024
73836197|NCT01543503|147221470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.752||||0.002|TWO_SIDED|95.0|-1.238|-0.267|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SJC, as the dependent variable; therapy and treatment as fixed effects; SJC, at baseline as the covariate.||-0.267|-1.238|0.002
73836198|NCT01543503|147221471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.123|TWO_SIDED|95.0|-1.408|0.169|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.||0.169|-1.408|0.123
73836199|NCT01543503|147221471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.216||||0.004|TWO_SIDED|95.0|-2.039|-0.393|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.||-0.393|-2.039|0.004
73836200|NCT01543503|147221472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.475|||<|0.001|TWO_SIDED|95.0|-5.481|-1.469|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CDAI the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.||-1.469|-5.481|<0.001
73836201|NCT01543503|147221472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6|||<|0.001|TWO_SIDED|95.0|-6.708|-2.492|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CDAI as the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.||-2.492|-6.708|<0.001
73836202|NCT01543503|147221472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.229||||0.014|TWO_SIDED|95.0|-5.806|-0.652|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.||-0.652|-5.806|0.014
73836203|NCT01543503|147221472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.245||||0.027|TWO_SIDED|95.0|-6.121|-0.37|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.||-0.370|-6.121|0.027
73836204|NCT01543503|147221473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.03|||<|0.001|TWO_SIDED|95.0|-12.655|-5.404|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.||-5.404|-12.655|<0.001
73836205|NCT01543503|147221473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.237|||<|0.001|TWO_SIDED|95.0|-14.13|-6.345|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.||-6.345|-14.130|<0.001
73836206|NCT01543503|147221477|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
73958831|NCT03538054|147453041|SUPERIORITY||Slope|-5.065||||0.146|TWO_SIDED|||||The clinical threshold was p \< 0.05, with no corrections for multiple comparisons.|GEE|Outcome scores were mean-centered by participant, allowing analyses to reflect within-person changes rather than between-person differences.||||||0.146
73958832|NCT03538054|147453042|SUPERIORITY||Slope|4.221||||0.052|TWO_SIDED|||||The clinical threshold was p \< 0.05, with no corrections for multiple comparisons.|GEE|Outcome scores were mean-centered by participant, allowing analyses to reflect within-person changes rather than between-person differences.||||||0.052
73958833|NCT03254394|147453044|SUPERIORITY||Mean Difference (Final Values)|6.88||||0.318|TWO_SIDED|95.0|-7.09|20.85||p-value was not adjusted for any parameter.|t-test, 2 sided|||Null hypothesis: Average AUC of cold pain score over 14 days of a chemotherapy cycle in the Control group is equal or lower than that of the experimental group. The comparison is for average AUC values over 7 cycles of chemotherapy per patient||20.85|-7.09|0.318
73836207|NCT01543503|147221481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.146||||0.02|TWO_SIDED|95.0|-0.269|-0.024|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.||-0.024|-0.269|0.020
73897620|NCT01106092|147328312|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||4.72|-4.78|
73958834|NCT03254394|147453044|SUPERIORITY||Mean Difference (Final Values)|7.67||||0.466|TWO_SIDED|95.0|-13.76|29.1||p-value was not adjusted for any parameter.|t-test, 2 sided|||Null hypothesis: Cold hypersensitivity counted as unpleasantness score for 14 days after cycle (AUC) in the Control group is less than that of the experimental group. The difference was calculated for the Cycle 6 visit.||29.10|-13.76|0.466
73958835|NCT03254394|147453045|SUPERIORITY||Median Difference (Final Values)|20.0||||0.338|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||the null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.||||0.338
73958836|NCT03254394|147453045|SUPERIORITY||Median Difference (Final Values)|2.0||||0.759|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the cycle 6 (12 weeks) follow-up study visit.||||0.759
73958837|NCT03254394|147453046|SUPERIORITY||Median Difference (Final Values)|0.0||||0.581|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C3 (6 weeks) study visit.||||0.581
73958838|NCT03254394|147453046|SUPERIORITY||Median Difference (Final Values)|0.0||||0.962|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C6 (12 weeks) study visit.||||0.962
73958839|NCT03254394|147453046|SUPERIORITY||Median Difference (Final Values)|10.5||||0.365|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.||||0.365
73958840|NCT03254394|147453047|SUPERIORITY||Mean Difference (Final Values)|57.68||||0.73|TWO_SIDED|95.0|-1771.0|1886.0|||t-test, 2 sided|||The null hypothesis is Oxaliplatin cumulative dose in the Control group is equal to or higher than that of the experimental group.||1886|-1771|0.730
73958841|NCT00387465|147453142|OTHER|The maximum tolerated dose (MTD) was derived from the number of participants experiencing dose-limiting toxicities in the Phase I arms. The MTD was the dose at which ≤30% of patients experienced DLTs during cycle 1 up to a pre-specified maximal dose of 40 mg/m2 of azacitidine.|Maximum Tolerated Dose|40.0|||||TWO_SIDED||||||||MTD of Azacitidine measured in mg/m\^2|||||
73958842|NCT03418324|147453153|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7|||||Estimated values reflects the percentage of participants with overall clinical benefit.|For this study, we are not comparing outcome measures between the two arms||98.7|1.3|
74020359|NCT02863068|147592920|SUPERIORITY|||||||1|||||||Fisher Exact|Fisher's exact test was used to test for differences in frequencies between treatment arms for participants off Hydroxyurea (HU).||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants off Hydroxyurea (HU).||||1.0
74020360|NCT02863068|147592921|SUPERIORITY|||||||0.4298||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.4298
74080665|NCT03214588|147713500|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|1.14||0.533|TWO_SIDED|90.0|-1.87|2.06||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.06|-1.87|0.533
73958843|NCT03418324|147453153|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm|Binomial proportion|66.7|||||TWO_SIDED|95.0|22.3|95.7|||||Estimated values reflects the percentage of participants with overall clinical benefit|For this study, we are not comparing outcome measures between the two groups.||95.7|22.3|
73958844|NCT03418324|147453156|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7||||||For this study, we are not comparing outcome measures between the two arms||98.7|1.3|
73958845|NCT03418324|147453156|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|66.7|||||TWO_SIDED|95.0|22.3|95.7||||||For this study, we are not comparing outcome measures between the two arms.||95.7|22.3|
73958846|NCT03418324|147453157|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7||||||For this study, we are not comparing outcome measures between the two arms.||98.7|1.3|
73958847|NCT03418324|147453157|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|11.8|88.2||||||For this study, we are not comparing outcome measures between the two arms.||88.2|11.8|
73958848|NCT05012644|147453160|OTHER||Odds Ratio (OR)|1.266|||||TWO_SIDED|95.0|0.715|2.241||||||||2.241|0.715|
73958849|NCT05012644|147453161|OTHER||Odds Ratio (OR)|1.508|||||TWO_SIDED|95.0|0.819|2.774||||||||2.774|0.819|
73958850|NCT03425643|147453170|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|1e-05|TWO_SIDED|95.0|0.48|0.72||One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Log Rank||Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|||0.72|0.48|<0.00001
74020361|NCT02863068|147592921|SUPERIORITY|||||||0.2701||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.2701
74020362|NCT00066690|147592944|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1|TWO_SIDED|95.0|0.66|1.04|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.|||1.04|0.66|0.1
74020363|NCT00066690|147592944|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.53|0.86|||||Tamoxifen was the reference group in the estimation of the hazard ratio.|||0.86|0.53|
74080666|NCT03214588|147713500|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.886||0.37|TWO_SIDED|90.0|-1.83|1.23||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.23|-1.83|0.370
73958851|NCT03425643|147453171|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00517|TWO_SIDED|95.0|0.56|0.93||One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Log Rank||Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|||0.93|0.56|0.00517
73958852|NCT03425643|147453172|OTHER|Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Percentage|19.2|||<|1e-05|TWO_SIDED|95.0|13.9|24.7|||Stratified Miettinen and Nurminen|||||24.7|13.9|<0.00001
73958853|NCT03425643|147453173|OTHER|Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Pertentage|14.2|||<|1e-05|TWO_SIDED|95.0|10.1|18.7|||Stratified Miettinen and Nurminen|||||18.7|10.1|<0.00001
73958854|NCT03425643|147453174|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Least Square Means|1.43||||0.3611|TWO_SIDED|95.0|-1.64|4.49|||t-test, 2 sided|||||4.49|-1.64|0.3611
73958855|NCT03425643|147453175|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Least Square Means|2.22||||0.1197|TWO_SIDED|95.0|-0.58|5.02|||t-test, 2 sided|||||5.02|-0.58|0.1197
73958856|NCT00482729|147453220|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||<|0.001||95.0|-0.78|-0.43|||ANCOVA|Model terms: treatment, baseline A1C||||-0.43|-0.78|<0.001
73958857|NCT00482729|147453221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07|||<|0.001||95.0|1.6|2.69||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.|ANCOVA|Model terms: treatment, baseline A1C|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.|||2.69|1.60|<0.001
73958858|NCT00482729|147453222|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.7|||<|0.001||95.0|-22.4|-9.0|||ANCOVA|Model terms: treatment, baseline A1C||||-9.0|-22.4|<0.001
74020364|NCT00066690|147592945|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.09|TWO_SIDED|95.0|0.3|1.03|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.|||1.03|0.3|0.09
74080667|NCT03214588|147713500|SUPERIORITY||Least Squares Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|1.078||0.972|TWO_SIDED|90.0|0.32|4.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||4.04|0.32|0.972
74080668|NCT03214588|147713500|SUPERIORITY||Least Squares Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.819||0.825|TWO_SIDED|90.0|-0.63|2.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||2.19|-0.63|0.825
73958859|NCT00482729|147453223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||||95.0|-0.67|-0.3|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0) A1C.|||-0.30|-0.67|
73958860|NCT00482729|147453224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||||95.0|1.63|2.73|||||This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 44 in the Sita/Met FDC group vs. the Metformin group, based on a logistic regression model with terms for treatment and baseline (i.e., Week 0) A1C|||2.73|1.63|
73958861|NCT02628093|147453232|OTHER|Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required.||||||0.214||||||P value threshold \<0.05|Wilcoxon (Mann-Whitney)|||Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required. Demographic, preoperative, and postoperative variables and the primary outcome were compared between groups (THUNDERBEAT and LigaSure) by the Wilcoxon rank-sum test for continuous variables and the chi-square test/Fisher's exact test for categorical variables, as appropriate. All p-values are two-sided with statistical significance evaluated at the 0.05 alpha level.||||0.214
73958862|NCT02628093|147453233|OTHER|||||||0.007||||||P value threshold \<0.05|Wilcoxon (Mann-Whitney)|||compared between groups by the Wilcoxon rank-sum test||||0.007
73958863|NCT02628093|147453237|OTHER|||||||1||||||P value threshold \<0.05|Fisher Exact|||||||1.0
73958864|NCT02525796|147453256|SUPERIORITY||Median Difference (Net)|3.2||||0.84|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between eplerenone monotherapy and placebo||||0.84
73958865|NCT02525796|147453256|SUPERIORITY||Median Difference (Net)|4.5||||0.54|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between amiloride monotherapy and placebo||||0.54
73958866|NCT02525796|147453256|SUPERIORITY||Median Difference (Net)|7.6||||0.58|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between eplerenone monotherapy and amiloride monotherapy||||0.58
73958867|NCT02525796|147453257|SUPERIORITY||Median Difference (Net)|0.0||||0.82|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between eplerenone monotherapy and placebo||||0.82
73958868|NCT02525796|147453257|SUPERIORITY||Median Difference (Net)|0.1||||0.21|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between amiloride monotherapy and placebo||||0.21
73958869|NCT02525796|147453257|SUPERIORITY||Median Difference (Net)|0.1||||0.12|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between eplerenone monotherapy and amiloride monotherapy||||0.12
73958870|NCT01499134|147453258|SUPERIORITY_OR_OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
74020365|NCT00066690|147592945|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.49|0.83|||||Tamoxifen was the reference group in the estimation of the hazard ratio.|||0.83|0.49|
74020366|NCT00066690|147592946|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4|TWO_SIDED|95.0|0.66|1.18|||Log Rank||T was the reference group in the estimation of the hazard ratio.|||1.18|0.66|0.40
73836208|NCT01543503|147221481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.02|TWO_SIDED|95.0|-0.301|-0.026|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.||-0.026|-0.301|0.020
73836209|NCT01543503|147221482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.893||||0.032|TWO_SIDED|95.0|-7.457|-0.329|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.||-0.329|-7.457|0.032
73836210|NCT01543503|147221482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.787||||0.168|TWO_SIDED|95.0|-6.763|1.189|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.||1.189|-6.763|0.168
73836211|NCT01543503|147221483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.661||||0.009|TWO_SIDED|95.0|-9.912|-1.411|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in participant's VAS score as dependent variable; therapy and treatment as fixed effects; participant's VAS score at baseline as covariates.||-1.411|-9.912|0.009
73836212|NCT01543503|147221483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.802|||<|0.001|TWO_SIDED|95.0|-14.245|-5.36|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in participant's VAS score as dependent variable; therapy and treatment as fixed effects; participant's VAS score at baseline as covariates.||-5.360|-14.245|<0.001
73836213|NCT01543503|147221485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.108||||0.01|TWO_SIDED|95.0|-9.017|-1.2|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Patient's Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient's Global Assessment of Disease at baseline as covariates.||-1.200|-9.017|0.010
73836214|NCT01543503|147221485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.767|||<|0.001|TWO_SIDED|95.0|-12.161|-3.372|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Patient's Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient's Global Assessment of Disease at baseline as covariates.||-3.372|-12.161|<0.001
73836215|NCT04560309|147221528|SUPERIORITY|||||||0.993||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.993
73836216|NCT04560309|147221529|SUPERIORITY|||||||0.883||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.883
73836217|NCT04560309|147221530|SUPERIORITY|||||||0.034||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.034
73836218|NCT04560309|147221531|SUPERIORITY|||||||0.038||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.038
73836219|NCT04560309|147221532|SUPERIORITY|||||||0.423||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.423
73958871|NCT01499134|147453259|SUPERIORITY_OR_OTHER|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
74080669|NCT03214588|147713501|SUPERIORITY||Least Squares Mean Difference|0.045|STANDARD_ERROR_OF_MEAN|0.23858||0.426|TWO_SIDED|90.0|-0.3665|0.4565||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.4565|-0.3665|0.426
73836220|NCT04560309|147221533|SUPERIORITY|||||||0.216||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.216
73836221|NCT04560309|147221534|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.001
73836222|NCT04560309|147221535|SUPERIORITY|||||||0.043||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.043
73836223|NCT04560309|147221536|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.011
73836224|NCT04560309|147221537|SUPERIORITY|||||||0.975||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.975
73836225|NCT04560309|147221538|SUPERIORITY|||||||0.031||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.031
73836226|NCT04560309|147221539|SUPERIORITY|||||||0.549||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.549
73836227|NCT04560309|147221540|SUPERIORITY|||||||0.645||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.645
73836228|NCT04560309|147221541|SUPERIORITY|||||||0.33||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||After induction to anesthesia||||0.330
73836229|NCT04560309|147221541|SUPERIORITY|||||||0.352||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||5 minutes after cardiopulmonary bypass||||0.352
73836230|NCT04560309|147221541|SUPERIORITY|||||||0.544||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||2 hours after cardiopulmonary bypass||||0.544
73836231|NCT04560309|147221541|SUPERIORITY|||||||0.022||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||6 hours after cardiopulmonary bypass||||0.022
73836232|NCT04560309|147221541|SUPERIORITY|||||||0.038||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||24 hour after cardiopulmonary bypass||||0.038
73958872|NCT01499134|147453260|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||This p-value is correct, confirmed with report from statistician.|Wilcoxon (Mann-Whitney)|||||||1.000
73958873|NCT01499134|147453261|SUPERIORITY_OR_OTHER|||||||0.363|||||||Wilcoxon (Mann-Whitney)|||||||0.363
73958874|NCT01499134|147453262|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
73958875|NCT01499134|147453263|SUPERIORITY_OR_OTHER|||||||0.476|||||||Wilcoxon (Mann-Whitney)|||||||0.476
73836233|NCT04560309|147221542|SUPERIORITY|||||||0.2||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.200
73836234|NCT04560309|147221543|SUPERIORITY|||||||0.72||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.720
73836235|NCT04560309|147221544|SUPERIORITY|||||||0.042||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.042
74020367|NCT00066690|147592946|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.52|0.96|||||T was the reference group in the estimation of hazard ratio.|||0.96|0.52|
74020368|NCT00066690|147592947|SUPERIORITY|\[not specified\]|Hazard Ratio (HR)|0.67||||0.01|TWO_SIDED|95.0|0.48|0.92|||Log Rank||T was the reference group in the estimation of the hazard ratio|||0.92|0.48|0.01
74020369|NCT00066690|147592947|SUPERIORITY|\[not specified\]|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.62|1.15|||||T was the reference group in the estimation of hazard ratio|||1.15|0.62|
74020370|NCT05256888|147592949|SUPERIORITY||Slope|-1.77|STANDARD_ERROR_OF_MEAN|1.08||0.11|TWO_SIDED||||||Regression, Linear|||"In a linear model to assess group effects on fatigue at 12 weeks, adjusting for baseline levels of fatigue:~Effect of group = -1.77±1.08, p=0.11, favoring the TRE group."||||0.11
74080670|NCT03214588|147713501|SUPERIORITY||Least Squares Mean Difference|-0.3281|STANDARD_ERROR_OF_MEAN|0.15794||0.975|TWO_SIDED|90.0|-0.6005|-0.0557||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||-0.0557|-0.6005|0.975
73930692|NCT03238911|147391292|SUPERIORITY||Mean Difference (Final Values)|20.14|||<|0.0001|TWO_SIDED|95.0|12.07|28.22|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||28.22|12.07|<0.0001
73958876|NCT01499134|147453264|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.170
73958877|NCT01499134|147453265|SUPERIORITY_OR_OTHER|||||||0.595|||||||Wilcoxon (Mann-Whitney)|||||||0.595
73958878|NCT01198275|147453267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.441|||<|0.05|TWO_SIDED|95.0|0.292|0.666|||Kaplan Meyer analysis|The time to first AF recurrence was analyzed with the Kaplan-Meier method and compared with the log-rank test.|Hazard ratios between n-3 PUFA and Placebo together with confidence intervals were estimated using the Cox proportional regression model.|Give a relapse rate ranging from 40% to 60% on ACE-I/ARB and amiodarone therapy, considering the high risk of relapses in our study population we conservatively assumed a 50% relapse rate. We calculated that a total of 180 patients would yield 80% power to detect a clinically relevant difference of about 20% in AF recurrence with the addition of n-3 PUFAs at a log-rank test, with a significance level of 0.05.||0.666|0.292|< 0.05
73958879|NCT02729701|147453279|OTHER|||||||0.017||||||a priori threshold for statistical significance \<0.05|Wilcoxon (Mann-Whitney)|||Test for within-group change by paired two-sample non-parametric test||||0.017
73958880|NCT02729701|147453280|OTHER|||||||0.043||||||a priori threshold for statistical significance \<0.05|Wilcoxon (Mann-Whitney)|2-sided||Test for within-group change via paired, two-sample non-parametric test||||0.043
73958881|NCT02729701|147453281|OTHER|||||||0.088||||||a priori threshold for statistical significance \< 0.05|Wilcoxon (Mann-Whitney)|||Test for within-group change using paired two-sample non-parametric etst||||0.088
73958882|NCT00970307|147453286|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.76|||||TWO_SIDED|95.0|-4.21|2.22||||||||2.22|-4.21|
73958883|NCT00970307|147453287|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardized asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.72|||||TWO_SIDED|95.0|-5.19|3.57||||||||3.57|-5.19|
73958884|NCT03110458|147453358|SUPERIORITY|||||||0.8466|||||||ANCOVA|||||||0.8466
73958885|NCT03110458|147453359|SUPERIORITY|||||||0.9538|||||||ANCOVA|||||||0.9538
73958886|NCT03110458|147453360|SUPERIORITY|||||||0.3166|||||||ANCOVA|||||||0.3166
73958887|NCT03110458|147453361|SUPERIORITY|||||||0.393|||||||ANCOVA|||||||0.393
73958888|NCT03110458|147453364|SUPERIORITY|||||||0.5324|||||||ANCOVA|||||||0.5324
73958889|NCT03923491|147453378|SUPERIORITY||Slope|-0.55|STANDARD_ERROR_OF_MEAN|4.69||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total score controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
74020371|NCT03706365|147592953|OTHER||Hazard Ratio (HR)|0.829||||0.2123|TWO_SIDED|95.0|0.619|1.111|||Log Rank|||||1.111|0.619|0.2123
74020372|NCT03706365|147592954|OTHER||Hazard Ratio (HR)|0.637||||0.0026|TWO_SIDED|95.0|0.474|0.856|||Log Rank|||||0.856|0.474|0.0026
74020373|NCT03706365|147592955|OTHER||Hazard Ratio (HR)|0.842||||0.2899|TWO_SIDED|95.0|0.611|1.16|||Log Rank|||||1.160|0.611|0.2899
74020374|NCT03706365|147592957|OTHER||Hazard Ratio (HR)|0.731||||0.3531|TWO_SIDED|95.0|0.377|1.419|||Log Rank|||||1.419|0.377|0.3531
74020375|NCT03706365|147592958|OTHER||Hazard Ratio (HR)|0.927||||0.6507|TWO_SIDED|95.0|0.669|1.285|||Log Rank|||||1.285|0.669|0.6507
74020376|NCT03706365|147592959|OTHER||Hazard Ratio (HR)|0.768||||0.1807|TWO_SIDED|95.0|0.522|1.131|||Log Rank|||||1.131|0.522|0.1807
74020377|NCT03706365|147592964|OTHER||Hazard Ratio (HR)|0.935||||0.697|TWO_SIDED|95.0|0.665|1.314|||Log Rank|||||1.314|0.665|0.6970
74020378|NCT03116113|147592967|SUPERIORITY||||||=|0.3181|||||||Fisher's Exact-Boschloo test|||||||=0.3181
74020379|NCT03116113|147592967|SUPERIORITY||||||=|0.5177|||||||Fisher's Exact-Boschloo test|||||||=0.5177
74020380|NCT05195528|147593024|SUPERIORITY||Difference in least square mean|17.1|||<|0.0001|TWO_SIDED|95.0|11.81|22.45||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||22.45|11.81|<0.0001
74080671|NCT03214588|147713501|SUPERIORITY||Least Squares Mean Difference|0.1448|STANDARD_ERROR_OF_MEAN|0.31186||0.324|TWO_SIDED|90.0|-0.3931|0.6826||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.6826|-0.3931|0.324
74080672|NCT03214588|147713501|SUPERIORITY||Least Squares Mean Difference|0.0113|STANDARD_ERROR_OF_MEAN|0.23213||0.481|TWO_SIDED|90.0|-0.3891|0.4117||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.4117|-0.3891|0.481
74020381|NCT05195528|147593024|SUPERIORITY||Least square mean difference|16.7|||<|0.0001|TWO_SIDED|95.0|11.36|22.04||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||22.04|11.36|<0.0001
74020382|NCT05195528|147593025|SUPERIORITY||Least square mean difference|15.8|||<|0.0001|TWO_SIDED|95.0|9.93|21.6||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||21.60|9.93|<0.0001
74020383|NCT05195528|147593025|SUPERIORITY||Least square mean difference|13.7|||<|0.0001|TWO_SIDED|95.0|7.84|19.54||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||19.54|7.84|<0.0001
74020384|NCT01552902|147593026|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-3.4|||=|0.0013|TWO_SIDED|95.0|-5.4|-1.3|||Mixed Models Analysis|||The least squares mean (LSM), the difference in LSM and its 95% confidence interval (CI), and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on Restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance.||-1.3|-5.4|= 0.0013
74020385|NCT01552902|147593026|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.0|-6.0|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.||-6|-11|< 0.0001
74020386|NCT01552902|147593026|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.6|-2.6|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that includes treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.||-2.6|-7.6|< 0.0001
74020387|NCT02064764|147593040|OTHER|Log-Rank Test For Comparing Treatment and Control||||||0.28|||||||Log Rank|||||||0.28
74080673|NCT03214588|147713501|SUPERIORITY||Least Squares Mean Difference|-0.2067|STANDARD_ERROR_OF_MEAN|0.28088||0.765|TWO_SIDED|90.0|-0.6911|0.2778||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.2778|-0.6911|0.765
74080674|NCT03214588|147713501|SUPERIORITY||Least Squares Mean Difference|0.1173|STANDARD_ERROR_OF_MEAN|0.19778||0.28|TWO_SIDED|90.0|-0.2238|0.4585||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.4585|-0.2238|0.280
74020388|NCT02064764|147593041|OTHER|||||||0.7348|||||||Log Rank|||||||0.7348
74020389|NCT06415305|147593050|SUPERIORITY||||||<|0.008|||||||Wilcoxon signed rank tests|||||||<0.008
74020390|NCT06415305|147593051|SUPERIORITY|||||||0.009|||||||Wilcoxon signed rank tests|||||||0.009
74020391|NCT06415305|147593052|SUPERIORITY|||||||0.008|||||||Wilcoxon signed rank tests|||||||0.008
74020392|NCT06415305|147593053|SUPERIORITY|||||||0.009|||||||Wilcoxon signed rank tests|||||||0.009
74020393|NCT02487108|147593060|OTHER||LS Mean Difference|38.9|||<|0.001|TWO_SIDED|95.0|19.931|57.855|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||57.855|19.931|<0.001
74020394|NCT02487108|147593060|OTHER||LS Mean Difference|44.0|||<|0.001|TWO_SIDED|95.0|25.122|62.881|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||62.881|25.122|<0.001
74020395|NCT02487108|147593060|OTHER||LS Mean Difference|53.4|||<|0.001|TWO_SIDED|95.0|34.589|72.282|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||72.282|34.589|<0.001
74020396|NCT00600171|147593071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.208|TWO_SIDED|95.0|-0.036|0.164|||ANCOVA|||||0.164|-0.036|0.208
74020397|NCT00600171|147593071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069||||0.169|TWO_SIDED|95.0|-0.029|0.168|||ANCOVA|||||0.168|-0.029|0.169
74080675|NCT03214588|147713502|SUPERIORITY||Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|4.28||0.735|TWO_SIDED|90.0|-9.9|4.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.4|-9.9|0.735
74080676|NCT03214588|147713502|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.51||0.182|TWO_SIDED|90.0|-2.7|9.1||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||9.1|-2.7|0.182
74020398|NCT00600171|147593071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.011|TWO_SIDED|95.0|0.03|0.23|||ANCOVA|||||0.230|0.030|0.011
74020399|NCT00600171|147593071|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.121||||0.016|TWO_SIDED|95.0|0.023|0.22|||ANCOVA|||||0.220|0.023|0.016
74020400|NCT00600171|147593071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162||||0.001|TWO_SIDED|95.0|0.062|0.261|||ANCOVA|||||0.261|0.062|0.001
74020401|NCT00988247|147593135|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-0.97|||<|0.001|TWO_SIDED|95.0|-1.5|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.5|-1.5|<0.001
74020402|NCT00988247|147593136|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-0.96|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.5|-1.4|<0.001
74020403|NCT00988247|147593137|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-1.09|||<|0.001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.6|-1.6|<0.001
74020404|NCT00988247|147593138|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-1.1|||<|0.001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.6|-1.6|<0.001
74020405|NCT00988247|147593139|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.3||||0.143|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.||||0.1|-0.7|0.143
74020406|NCT00988247|147593140|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.49||||0.13|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.||||0.1|-1.1|0.130
74020407|NCT00956930|147593146|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.122||||0.007|TWO_SIDED|95.0|0.027|0.557|||Log Rank|||||0.557|0.027|0.007
74020408|NCT02908100|147593162|SUPERIORITY||Absolute Difference|6.4||||0.373|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.373
74020409|NCT02908100|147593162|SUPERIORITY||Absolute Difference|7.5||||0.339|TWO_SIDED|95.0|-7.3|22.4|||Cochran-Mantel-Haenszel|||||22.4|-7.3|0.339
74020410|NCT02908100|147593163|SUPERIORITY||Absolute Difference|8.7||||0.223|TWO_SIDED|95.0|-6.1|23.5|||Cochran-Mantel-Haenszel|||||23.5|-6.1|0.223
74020411|NCT02908100|147593163|SUPERIORITY||Absolute Difference|3.0||||0.737|TWO_SIDED|95.0|-11.8|17.7|||Cochran-Mantel-Haenszel|||||17.7|-11.8|0.737
74020412|NCT02908100|147593164|SUPERIORITY||Absolute Difference|4.1||||0.614|TWO_SIDED|95.0|-10.7|18.9|||Cochran-Mantel-Haenszel|||||18.9|-10.7|0.614
74020413|NCT02908100|147593164|SUPERIORITY||Absolute Difference|4.1||||0.607|TWO_SIDED|95.0|-10.7|18.9|||Cochran-Mantel-Haenszel|||||18.9|-10.7|0.607
74080677|NCT03214588|147713502|SUPERIORITY||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|3.59||0.97|TWO_SIDED|90.0|-12.9|-0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||-0.9|-12.9|0.970
74020414|NCT02908100|147593165|SUPERIORITY||Absolute Difference|6.4||||0.41|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.410
74020415|NCT02908100|147593165|SUPERIORITY||Absolute Difference|6.4||||0.418|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.418
74020416|NCT02908100|147593166|SUPERIORITY||Absolute Difference|14.9||||0.378|TWO_SIDED|95.0|-14.0|43.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||43.7|-14|0.378
74020417|NCT02908100|147593166|SUPERIORITY||Absolute Difference|7.5||||0.732|TWO_SIDED|95.0|-21.7|36.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||36.7|-21.7|0.732
74080678|NCT03214588|147713502|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|3.0||0.321|TWO_SIDED|90.0|-3.6|6.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||6.4|-3.6|0.321
74080679|NCT03214588|147713502|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|4.34||0.905|TWO_SIDED|90.0|-13.0|1.5||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.5|-13.0|0.905
73836236|NCT04560309|147221545|SUPERIORITY|||||||0.044||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.044
74020418|NCT02908100|147593166|SUPERIORITY||Absolute Difference|-0.4||||0.5|TWO_SIDED|95.0|-29.2|28.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||28.4|-29.2|0.500
74020419|NCT02908100|147593166|SUPERIORITY||Absolute Difference|8.6||||0.234|TWO_SIDED|95.0|-21.4|38.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||38.7|-21.4|0.234
74020420|NCT02908100|147593166|SUPERIORITY||Absolute Difference|15.5||||0.364|TWO_SIDED|95.0|-14.9|46.0|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||46|-14.9|0.364
74020421|NCT02908100|147593166|SUPERIORITY||Absolute Difference|15.2||||0.134|TWO_SIDED|95.0|-14.1|44.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||44.4|-14.1|0.134
74020422|NCT02908100|147593166|SUPERIORITY||Absolute Difference|-7.1||||0.83|TWO_SIDED|95.0|-37.6|23.3|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||23.3|-37.6|0.830
74020423|NCT02908100|147593166|SUPERIORITY||Absolute Difference|-2.2||||0.963|TWO_SIDED|95.0|-32.1|27.8|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||27.8|-32.1|0.963
74020424|NCT02908100|147593167|SUPERIORITY||Absolute Difference|19.0||||0.189|TWO_SIDED|95.0|-9.4|47.5|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||47.5|-9.4|0.189
74020425|NCT02908100|147593167|SUPERIORITY||Absolute Difference|6.7||||0.909|TWO_SIDED|95.0|-21.9|35.2|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||35.2|-21.9|0.909
74020426|NCT02908100|147593167|SUPERIORITY||Absolute Difference|-0.4||||0.5|TWO_SIDED|95.0|-29.2|28.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||28.4|-29.2|0.500
74020427|NCT02908100|147593167|SUPERIORITY||Absolute Difference|3.3||||0.234|TWO_SIDED|95.0|-27.1|33.8|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||33.8|-27.1|0.234
74020428|NCT02908100|147593167|SUPERIORITY||Absolute Difference|15.5||||0.364|TWO_SIDED|95.0|-14.9|46.0|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||46|-14.9|0.364
74020429|NCT02908100|147593167|SUPERIORITY||Absolute Difference|7.2||||0.31|TWO_SIDED|95.0|-22.0|36.3|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||36.3|-22|0.310
74020430|NCT02908100|147593167|SUPERIORITY||Absolute Difference|-2.1||||0.922|TWO_SIDED|95.0|-32.5|28.2|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||28.2|-32.5|0.922
74020431|NCT02908100|147593167|SUPERIORITY||Absolute Difference|-5.9||||0.701|TWO_SIDED|95.0|-35.4|23.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||23.7|-35.4|0.701
74020432|NCT02908100|147593168|SUPERIORITY||Absolute Difference|3.1||||0.692|TWO_SIDED|95.0|-10.9|17.1|||Cochran-Mantel-Haenszel|||Week 24||17.1|-10.9|0.692
73836237|NCT04560309|147221546|SUPERIORITY|||||||0.349||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.349
74020433|NCT02908100|147593168|SUPERIORITY||Absolute Difference|1.9||||0.871|TWO_SIDED|95.0|-12.0|15.9|||Cochran-Mantel-Haenszel|||Week 24||15.9|-12|0.871
74020434|NCT02908100|147593168|SUPERIORITY||Absolute Difference|11.2||||0.105|TWO_SIDED|95.0|-2.8|25.1|||Cochran-Mantel-Haenszel|||Week 48||25.1|-2.8|0.105
74020435|NCT02908100|147593168|SUPERIORITY||Absolute Difference|7.7||||0.286|TWO_SIDED|95.0|-6.1|21.6|||Cochran-Mantel-Haenszel|||Week 48||21.6|-6.1|0.286
74080680|NCT03214588|147713502|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.57||0.199|TWO_SIDED|90.0|-2.9|9.0||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||9.0|-2.9|0.199
74080681|NCT03214588|147713503|SUPERIORITY|||||||0.974||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.974
74080682|NCT03214588|147713503|SUPERIORITY|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.893
74080683|NCT03214588|147713503|SUPERIORITY|||||||0.954||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.954
74080684|NCT03214588|147713503|SUPERIORITY|||||||0.793||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.793
74080685|NCT03214588|147713503|SUPERIORITY|||||||0.845||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.845
74080686|NCT03214588|147713503|SUPERIORITY|||||||0.816||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.816
74080687|NCT03214588|147713504|SUPERIORITY|||||||0.84||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.840
74080688|NCT03214588|147713504|SUPERIORITY|||||||0.854||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.854
74080689|NCT03214588|147713504|SUPERIORITY|||||||0.922||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.922
74080690|NCT03214588|147713504|SUPERIORITY|||||||0.794||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.794
74080691|NCT03214588|147713504|SUPERIORITY|||||||0.83||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.830
74080692|NCT03214588|147713504|SUPERIORITY|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.998
74080693|NCT03214588|147713505|SUPERIORITY|||||||0.987||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.987
74080694|NCT03214588|147713505|SUPERIORITY|||||||0.771||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.771
74080695|NCT03214588|147713505|SUPERIORITY|||||||0.526||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.526
74080696|NCT03214588|147713505|SUPERIORITY|||||||0.665||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.665
74080697|NCT03214588|147713505|SUPERIORITY|||||||0.576||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.576
74080698|NCT03214588|147713505|SUPERIORITY|||||||0.865||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.865
74080699|NCT03214588|147713506|SUPERIORITY|||||||0.966||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.966
74080700|NCT03214588|147713506|SUPERIORITY|||||||0.983||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.983
74080701|NCT03214588|147713506|SUPERIORITY|||||||0.953||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.953
74080702|NCT03214588|147713506|SUPERIORITY|||||||0.781||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.781
74080703|NCT03214588|147713506|SUPERIORITY|||||||0.948||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.948
74080704|NCT03214588|147713506|SUPERIORITY|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.998
74080705|NCT03214588|147713507|SUPERIORITY|||||||0.666||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.666
74080706|NCT03214588|147713507|SUPERIORITY|||||||0.812||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.812
74080707|NCT03214588|147713507|SUPERIORITY|||||||0.834||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.834
74080708|NCT03214588|147713507|SUPERIORITY|||||||0.841||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.841
74080709|NCT03214588|147713507|SUPERIORITY|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.893
73836238|NCT04560309|147221547|SUPERIORITY|||||||0.95||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.950
74080710|NCT03214588|147713507|SUPERIORITY|||||||0.907||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.907
74080711|NCT03214588|147713508|SUPERIORITY|||||||0.032||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.032
74080712|NCT03214588|147713508|SUPERIORITY|||||||0.216||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.216
74080713|NCT03214588|147713508|SUPERIORITY|||||||0.215||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.215
74080714|NCT03214588|147713508|SUPERIORITY|||||||0.411||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.411
74080715|NCT03214588|147713508|SUPERIORITY|||||||0.194||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.194
74080716|NCT03214588|147713508|SUPERIORITY|||||||0.408||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.408
74080717|NCT03214588|147713509|SUPERIORITY|||||||0.406||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.406
74080718|NCT03214588|147713509|SUPERIORITY|||||||0.235||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.235
74080719|NCT03214588|147713509|SUPERIORITY|||||||0.225||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.225
74080720|NCT03214588|147713509|SUPERIORITY|||||||0.434||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.434
74080721|NCT03214588|147713509|SUPERIORITY|||||||0.249||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.249
74080722|NCT03214588|147713509|SUPERIORITY|||||||0.38||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.380
74080723|NCT03214588|147713510|SUPERIORITY|||||||0.422||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.422
74080724|NCT03214588|147713510|SUPERIORITY|||||||0.226||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.226
73836239|NCT04560309|147221548|SUPERIORITY|The threshold of statistical significance was p \< 0.05||||||0.862|||||||Wilcoxon (Mann-Whitney)|||||||0.862
74020436|NCT02908100|147593169|SUPERIORITY||Absolute Difference|-1.6||||0.936|TWO_SIDED|95.0|-16.8|13.6|||Cochran-Mantel-Haenszel|||Week 24||13.6|-16.8|0.936
74080725|NCT03214588|147713510|SUPERIORITY|||||||0.639||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.639
74080726|NCT03214588|147713510|SUPERIORITY|||||||0.094||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.094
74080727|NCT03214588|147713510|SUPERIORITY|||||||0.516||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.516
74080728|NCT03214588|147713510|SUPERIORITY|||||||0.266||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.266
74080729|NCT03214588|147713511|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.362||0.299|TWO_SIDED|90.0|-0.8|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.41|-0.80|0.299
74080730|NCT03214588|147713511|SUPERIORITY||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.293||0.967|TWO_SIDED|90.0|0.06|1.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.04|0.06|0.967
74080731|NCT03214588|147713511|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.338||0.529|TWO_SIDED|90.0|-0.54|0.59||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.59|-0.54|0.529
74080732|NCT03214588|147713511|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.279||0.88|TWO_SIDED|90.0|-0.13|0.8||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.80|-0.13|0.880
74080733|NCT03214588|147713511|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.408||0.599|TWO_SIDED|90.0|-0.58|0.79||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.79|-0.58|0.599
74080734|NCT03214588|147713511|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.333||0.846|TWO_SIDED|90.0|-0.21|0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.90|-0.21|0.846
74080735|NCT03214588|147713512|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline||||>0.999
74080736|NCT03214588|147713512|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline||||>0.999
74080737|NCT03214588|147713512|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline||||>0.999
74080738|NCT03214588|147713512|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline||||>0.999
74080739|NCT03480763|147713516|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.2||||0.043|TWO_SIDED|95.0|0.1|8.5|||Miettinen & Nurminen|||Injection site redness/erythema||8.5|0.1|0.043
74080740|NCT03480763|147713516|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|13.7|||<|0.001|TWO_SIDED|95.0|6.0|21.2|||Miettinen & Nurminen|||Injection site tenderness/pain||21.2|6.0|<0.001
74080741|NCT03480763|147713516|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.8||||0.077|TWO_SIDED|95.0|-0.5|10.2|||Miettinen & Nurminen|||Injection site swelling||10.2|-0.5|0.077
74080742|NCT03480763|147713517|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.6||||0.855|TWO_SIDED|95.0|-5.5|6.6|||Miettinen & Nurminen|||Injection site redness/erythema||6.6|-5.5|0.855
74080743|NCT03480763|147713517|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|3.5||||0.385||95.0|-4.4|11.3|||Miettinen & Nurminen|||Injection site tenderness/pain||11.3|-4.4|0.385
74080744|NCT03480763|147713517|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|2.0||||0.577|TWO_SIDED|95.0|-5.1|9.2|||Miettinen & Nurminen|||Injection site swelling||9.2|-5.1|0.577
74080745|NCT03480763|147713518|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.2||||0.523|TWO_SIDED|95.0|-2.5|4.9|||Miettinen & Nurminen|||Joint pain/arthralgia||4.9|-2.5|0.523
74080746|NCT03480763|147713518|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|9.7||||0.002|TWO_SIDED|95.0|3.7|15.6|||Miettinen & Nurminen|||Tiredness/fatigue||15.6|3.7|0.002
74080747|NCT03480763|147713518|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.4||||0.597|TWO_SIDED|95.0|-3.9|6.7|||Miettinen & Nurminen|||Headache||6.7|-3.9|0.597
74080748|NCT03480763|147713518|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|6.6||||0.016|TWO_SIDED|95.0|1.2|12.1|||Miettinen & Nurminen|||Muscle pain/myalgia||12.1|1.2|0.016
74020437|NCT02908100|147593169|SUPERIORITY||Absolute Difference|-2.9||||0.683|TWO_SIDED|95.0|-18.2|12.4|||Cochran-Mantel-Haenszel|||Week 24||12.4|-18.2|0.683
74080749|NCT03480763|147713519|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.1||||0.961|TWO_SIDED|95.0|-4.4|4.7|||Miettinen & Nurminen|||Joint pain/arthralgia||4.7|-4.4|0.961
74080750|NCT03480763|147713519|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.0||||0.252|TWO_SIDED|95.0|-2.8|10.8|||Miettinen & Nurminen|||Tiredness/fatigue||10.8|-2.8|0.252
74080751|NCT03480763|147713519|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.5||||0.852|TWO_SIDED|95.0|-5.8|4.8|||Miettinen & Nurminen|||Headache||4.8|-5.8|0.852
74080752|NCT03480763|147713519|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.9||||0.125|TWO_SIDED|95.0|-1.4|11.2|||Miettinen & Nurminen|||Muscle pain/myalgia||11.2|-1.4|0.125
74080753|NCT03480763|147713520|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.2|1.2||||||Vaccine-related SAEs following V114 or Prevnar 13™||1.2|-1.2|
74080754|NCT03480763|147713521|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||Vaccine-related SAEs following PNEUMOVAX™23||1.3|-1.3|
74080755|NCT03480763|147713522|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.38|||||TWO_SIDED|95.0|1.1|1.74||||||Serotype 1 (Shared)||1.74|1.10|
73836240|NCT04560309|147221549|SUPERIORITY|The threshold of statistical significance was p \< 0.05||||||0.075|||||||Wilcoxon (Mann-Whitney)|||||||0.075
73836241|NCT00137280|147221564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.01|TWO_SIDED|95.0|1.47|3.58|||Regression, Logistic||Comparison group is the control (denominator)|||3.58|1.47|<0.01
74020438|NCT02908100|147593169|SUPERIORITY||Absolute Difference|11.7||||0.086|TWO_SIDED|95.0|-3.4|26.8|||Cochran-Mantel-Haenszel|||Week 48||26.8|-3.4|0.086
74020439|NCT02908100|147593169|SUPERIORITY||Absolute Difference|0.9||||0.879|TWO_SIDED|95.0|-14.2|16.1|||Cochran-Mantel-Haenszel|||Week 48||16.1|-14.2|0.879
73836242|NCT00137280|147221565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.02|STANDARD_ERROR_OF_MEAN|5.93||0.03|||||||ANCOVA|||||||.03
73836243|NCT00137280|147221566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.01|TWO_SIDED|95.0|1.22|4.34|||Regression, Logistic||Comparison group is the control (denominator)|||4.34|1.22|<0.01
74080756|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model|GMT Ratio|1.08|||||TWO_SIDED|95.0|0.9|1.29||||||Serotype 3 (Shared)||1.29|0.90|
74080757|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||Serotype 4 (Shared)||1.32|0.85|
74080758|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model|GMT Ratio|1.21|||||TWO_SIDED|95.0|0.94|1.56||||||Serotype 5 (Shared)||1.56|0.94|
74080759|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.16|||||TWO_SIDED|95.0|0.95|1.43||||||Serotype 6A (Shared)||1.43|0.95|
74080760|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.12|||||TWO_SIDED|95.0|0.93|1.35||||||Serotype 6B (Shared)||1.35|0.93|
74080761|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||Serotype 7F (Shared)||1.25|0.90|
74080762|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.91|1.33||||||Serotype 9V (Shared)||1.33|0.91|
74080763|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.27|||||TWO_SIDED|95.0|1.05|1.53||||||Serotype 14 (Shared)||1.53|1.05|
74080764|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.13|||||TWO_SIDED|95.0|0.95|1.34||||||Serotype 18C (Shared)||1.34|0.95|
74080765|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.96|1.38||||||Serotype 19A (Shared)||1.38|0.96|
74080766|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.89|1.2||||||Serotype 19F (Shared)||1.20|0.89|
74080767|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.01|1.61||||||Serotype 23F (Shared)||1.61|1.01|
74080768|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.63|||||TWO_SIDED|95.0|1.29|2.06||||||Serotype 22F (Unique to V114)||2.06|1.29|
74080769|NCT03480763|147713522|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.77|1.17||||||Serotype 33F (Unique to V114)||1.17|0.77|
74080770|NCT03480763|147713523|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07||||||Serotype 1 (Shared)||1.07|0.79|
74080771|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.16||||||Serotype 3 (Shared)||1.16|0.87|
74080772|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.87|||||TWO_SIDED|95.0|0.74|1.02||||||Serotype 4 (Shared)||1.02|0.74|
74080773|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.84|1.18||||||Serotype 5 (Shared)||1.18|0.84|
74080774|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.41||||||Serotype 6A (Shared)||1.41|0.96|
74080775|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.4||||||Serotype 6B (Shared)||1.40|0.96|
74080776|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||Serotype 7F (Shared)||1.16|0.85|
74080777|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.89|1.22||||||Serotype 9V (Shared)||1.22|0.89|
74080778|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.17|||||TWO_SIDED|95.0|0.98|1.39||||||Serotype 14 (Shared)||1.39|0.98|
74080779|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|1.0|1.36||||||Serotype 18C (Shared)||1.36|1.00|
73836244|NCT00137280|147221567|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||||||.11
73836245|NCT05001165|147221573|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.1|0.7|||Regression, Linear|||||0.7|-0.1|
74080780|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.29||||||Serotype 19A (Shared)||1.29|0.95|
74080781|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.93|1.27||||||Serotype 19F (Shared)||1.27|0.93|
74080782|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|0.96|1.35||||||Serotype 23F (Shared)||1.35|0.96|
74080783|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.16|1.77||||||Serotype 22F (Unique to V114)||1.77|1.16|
74080784|NCT03480763|147713523|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95||||||Serotype 33F (Unique to V114)||0.95|0.67|
74080785|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.94|1.58||||||Serotype 1 (Shared)||1.58|0.94|
74080786|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.56|2.3||||||Serotype 3 (Shared)||2.30|1.56|
74080787|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||Serotype 4 (Shared)||0.97|0.60|
74080788|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.07|||||TWO_SIDED|95.0|0.81|1.4||||||Serotype 5 (Shared)||1.40|0.81|
74080789|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.92|1.53||||||Serotype 6A (Shared)||1.53|0.92|
74080790|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.64|||||TWO_SIDED|95.0|1.31|2.06||||||Serotype 6B (Shared)||2.06|1.31|
74080791|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.14||||||Serotype 7F (Shared)||1.14|0.80|
74080792|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.83|1.24||||||Serotype 9V (Shared)||1.24|0.83|
74080793|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.37||||||Serotype 14 (Shared)||1.37|0.87|
74080794|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.48|||||TWO_SIDED|95.0|1.2|1.84||||||Serotype 18C (Shared)||1.84|1.20|
74080795|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.06|1.55||||||Serotype 19A (Shared)||1.55|1.06|
74080796|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.92|1.32||||||Serotype 19F (Shared)||1.32|0.92|
74080797|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.53|||||TWO_SIDED|95.0|1.18|2.0||||||Serotype 23F (Shared)||2.00|1.18|
74080798|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|34.86|||||TWO_SIDED|95.0|26.13|46.5||||||Serotype 22F (Unique to V114)||46.50|26.13|
74080799|NCT03480763|147713524|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|9.15|||||TWO_SIDED|95.0|7.48|11.2||||||Serotype 33F (Unique to V114)||11.20|7.48|
74080800|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.72|1.09||||||Serotype 1 (Shared)||1.09|0.72|
74080801|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.74|||||TWO_SIDED|95.0|1.46|2.07||||||Serotype 3 (Shared)||2.07|1.46|
74080802|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.99||||||Serotype 4 (Shared)||0.99|0.64|
74080803|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.84|1.3||||||Serotype 5 (Shared)||1.30|0.84|
73836246|NCT05001165|147221574|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.84|2.14|||Regression, Logistic|||||2.14|0.84|
74080804|NCT03480763|147713525|OTHER|GMCs, GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.77||||||Serotype 6A (Shared)||1.77|1.10|
74080805|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.64|||||TWO_SIDED|95.0|1.28|2.1||||||Serotype 6B (Shared)||2.10|1.28|
73958890|NCT03923491|147453378|SUPERIORITY||Slope|-0.35|STANDARD_ERROR_OF_MEAN|0.49||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total vegetable component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
73958891|NCT03923491|147453378|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.88||0.2|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 greens and beans component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.20
74080806|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.74|1.13||||||Serotype 7F (Shared)||1.13|0.74|
74080807|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.91|1.41||||||Serotype 9V (Shared)||1.41|0.91|
74080808|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.38||||||Serotype 14 (Shared)||1.38|0.87|
74080809|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.56|||||TWO_SIDED|95.0|1.27|1.92||||||Serotype 18C (Shared)||1.92|1.27|
74080810|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.91|1.39||||||Serotype 19A (Shared)||1.39|0.91|
74080811|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|0.92|1.41||||||Serotype 19F (Shared)||1.41|0.92|
73836247|NCT05001165|147221575|SUPERIORITY||Odds Ratio (OR)|1.06|||<|0.05|TWO_SIDED|95.0|0.64|1.76|||Regression, Logistic|||||1.76|0.64|<0.05
73836248|NCT05001165|147221576|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.73|1.93|||Regression, Logistic|||||1.93|0.73|
73836249|NCT05001165|147221577|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.68|2.05|||Regression, Logistic|||||2.05|0.68|
73836250|NCT05001165|147221578|SUPERIORITY||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.88|2.51|||Regression, Logistic|||||2.51|0.88|
73836251|NCT05001165|147221579|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|0.99|3.64|||Regression, Logistic|||||3.64|0.99|
73836252|NCT05001165|147221580|SUPERIORITY||Odds Ratio (OR)|0.68|||||TWO_SIDED|95.0|0.34|1.33|||Regression, Logistic|||||1.33|0.34|
74080812|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.61|||||TWO_SIDED|95.0|1.27|2.04||||||Serotype 23F (Shared)||2.04|1.27|
74080813|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|16.54|||||TWO_SIDED|95.0|13.78|19.86||||||Serotype 22F (Unique to V114)||19.86|13.78|
74080814|NCT03480763|147713525|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|12.82|||||TWO_SIDED|95.0|10.82|15.19||||||Serotype 33F (Unique to V114)||15.19|10.82|
74080815|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.92|1.53||||||Serotype 1 (Shared)||1.53|0.92|
74080816|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.57|||||TWO_SIDED|95.0|1.29|1.9||||||Serotype 3 (Shared)||1.90|1.29|
74080817|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.9||||||Serotype 4 (Shared)||0.90|0.57|
74080818|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.78|1.33||||||Serotype 5 (Shared)||1.33|0.78|
74080819|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.93|1.41||||||Serotype 6A (Shared)||1.41|0.93|
74080820|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.43|||||TWO_SIDED|95.0|1.16|1.77||||||Serotype 6B (Shared)||1.77|1.16|
74080821|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.11||||||Serotype 7F (Shared)||1.11|0.80|
74080822|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.98|||||TWO_SIDED|95.0|0.81|1.18||||||Serotype 9V (Shared)||1.18|0.81|
74080823|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.9|1.36||||||Serotype 14 (Shared)||1.36|0.90|
74080824|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.05|1.55||||||Serotype 18C (Shared)||1.55|1.05|
74080825|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.31||||||Serotype 19A (Shared)||1.31|0.91|
74080826|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.08|||||TWO_SIDED|95.0|0.91|1.29||||||Serotype 19F (Shared)||1.29|0.91|
74080827|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.37|||||TWO_SIDED|95.0|1.06|1.76||||||Serotype 23F (Shared)||1.76|1.06|
74080828|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|12.79|||||TWO_SIDED|95.0|9.44|17.34||||||Serotype 22F (Unique to V114)||17.34|9.44|
74080829|NCT03480763|147713530|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|3.24|||||TWO_SIDED|95.0|2.73|3.84||||||Serotype 33F (Unique to V114)||3.84|2.73|
74080830|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.65|0.92||||||Serotype 1 (Shared)||0.92|0.65|
74080831|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.24|1.63||||||Serotype 3 (Shared)||1.63|1.24|
74080832|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.64|0.91||||||Serotype 4 (Shared)||0.91|0.64|
74080833|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.75|1.05||||||Serotype 5 (Shared)||1.05|0.75|
73958892|NCT03923491|147453378|SUPERIORITY||Slope|1.71|STANDARD_ERROR_OF_MEAN|0.67||0.2|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total fruit component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.20
74020440|NCT01688050|147593179|OTHER|The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|All-cause mortality rate (%)|2.0|||||TWO_SIDED|95.0|0.0|5.88|||||Wald method|||5.88|0|
74080834|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.37|||||TWO_SIDED|95.0|1.12|1.67||||||Serotype 6A (Shared)||1.67|1.12|
74080835|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.21|1.81||||||Serotype 6B (Shared)||1.81|1.21|
74080836|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||Serotype 7F (Shared)||1.02|0.72|
74080837|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.23||||||Serotype 9V (Shared)||1.23|0.88|
73836253|NCT04000724|147221585|SUPERIORITY||Average treatment effect|-0.54||||0.141|TWO_SIDED|95.0|-1.26|0.18|||Longitudinal Targeted Maximum Likelihood|||||0.18|-1.26|0.141
74080838|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.26||||||Serotype 14 (Shared)||1.26|0.88|
74080839|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.38|||||TWO_SIDED|95.0|1.17|1.64||||||Serotype 18C (Shared)||1.64|1.17|
74080840|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.97|1.33||||||Serotype 19A (Shared)||1.33|0.97|
74080841|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.96|1.32||||||Serotype 19F (Shared)||1.32|0.96|
74080842|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.35|||||TWO_SIDED|95.0|1.12|1.62||||||Serotype 23F (Shared)||1.62|1.12|
74080843|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|6.2|||||TWO_SIDED|95.0|5.33|7.21||||||Serotype 22F (Unique to V114)||7.21|5.33|
74080844|NCT03480763|147713531|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|5.01|||||TWO_SIDED|95.0|4.38|5.73||||||Serotype 33F (Unique to V114)||5.73|4.38|
74080845|NCT01906372|147713564|SUPERIORITY_OR_OTHER||Frequency of achieving primary endpoint|0.7|||||TWO_SIDED|||||Open label single arm pilot trial without control group.||||||||
74080846|NCT01906372|147713565|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
74080847|NCT03629054|147713566|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (gMean) (T/R).|Adjusted gMean ratio|100.42|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001|TWO_SIDED|90.0|98.17|102.72|||ANOVA||gMean ratio = T/R. Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV).|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||102.72|98.17|<0.0001
74080848|NCT03629054|147713567|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.34|STANDARD_ERROR_OF_MEAN|8.5|<|0.0001|TWO_SIDED|90.0|91.58|99.24|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||99.24|91.58|<0.0001
74080849|NCT03629054|147713568|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.16|STANDARD_ERROR_OF_MEAN|8.6|<|0.0001|TWO_SIDED|90.0|96.17|104.31|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||104.31|96.17|<0.0001
74080850|NCT03629054|147713569|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|92.57|STANDARD_ERROR_OF_MEAN|17.9||0.0029|TWO_SIDED|90.0|85.21|100.57|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||100.57|85.21|0.0029
74080851|NCT03629054|147713570|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|97.33|STANDARD_ERROR_OF_MEAN|16.9||0.0001|TWO_SIDED|90.0|89.99|105.26|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||105.26|89.99|0.0001
74080852|NCT03629054|147713571|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|104.83|STANDARD_ERROR_OF_MEAN|13.2|<|0.0001|TWO_SIDED|90.0|98.56|111.5|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||111.50|98.56|<0.0001
74080853|NCT03629054|147713572|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.73|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|90.0|98.33|103.18|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||103.18|98.33|<0.0001
74080854|NCT03629054|147713573|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|103.57|STANDARD_ERROR_OF_MEAN|14.3|<|0.0001|TWO_SIDED|90.0|96.9|110.71|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||110.71|96.90|<0.0001
74080855|NCT03629054|147713574|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.74|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|90.0|92.29|99.32|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||99.32|92.29|<0.0001
74080856|NCT01075516|147713586|OTHER|Continuous data summarized as mean ± Standard Deviation (SD). For cost data Wilcoxon rank-sum test was used to compare costs across groups. The analysis evaluated HCS perspective of group membership impact (SC vs RM) on total health care cost, adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals)|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74080857|NCT01075516|147713587|OTHER|Continuous data are summarized as mean ± SD. For cost data the Wilcoxon rank-sum test was used to compare costs across groups. This analysis evaluated the impact of group membership (SC vs RM) on cardiovascular hospitalization timeframe (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
74080858|NCT01075516|147713588|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.8||||||Comparison of utility at baseline from the EQ-5D-3L questionnaire.|t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EuroQoL Group 5-Dimension 3-Level Self-Report (EQ-5D-3L) questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.80
74080859|NCT01075516|147713588|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.38||||||Comparison of utility at 12 months from the EQ-5D-3L questionnaire.|t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.38
74088207|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.004|TWO_SIDED|95.0|-0.87|-0.16|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.16|-0.87|0.0040
73958893|NCT03923491|147453378|SUPERIORITY||Slope|2.14|STANDARD_ERROR_OF_MEAN|0.83||0.19|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 whole fruit component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.19
74020441|NCT01688050|147593180|OTHER|The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|Aortic injury-related mortality rate (%)|0.0|||||TWO_SIDED|95.0|0.0|7.1|||||Exact method|||7.1|0|
74020442|NCT01688050|147593181|OTHER|The primary effectiveness endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|Device success rate (%)|96.0|||||TWO_SIDED|95.0|90.6|100.0|||||Wald method|||100|90.6|
73836254|NCT04000724|147221585|SUPERIORITY||Average treatment effect|-0.51||||0.123|TWO_SIDED|95.0|-1.16|0.14|||Longitudinal Targeted Maximum Likelihood|||||0.14|-1.16|0.123
74020443|NCT00330187|147593207|SUPERIORITY||Odds Ratio (OR)|3.6||||0.07|TWO_SIDED|95.0|0.9|14.4|||Regression, Logistic|||||14.4|0.9|0.07
74020444|NCT00754156|147593251|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74080860|NCT01075516|147713588|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.53|||||||t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.53
74080861|NCT02252016|147713590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|-7.3|23.3||||||The estimated difference (± 95% confidence interval \[CI\]) in percentage of participants experiencing an AE in the Immediate versus Deferred arms was determined.||23.3|-7.3|
74080862|NCT02252016|147713591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.155|TWO_SIDED|95.0|-10.2|1.6|||Miettinen & Nurminen method|||The estimated difference (± 95% CI) in percentage of participants withdrawing from study treatment due to an AE(s) in the Immediate versus Deferred arms was determined.||1.6|-10.2|0.155
74080863|NCT02055547|147713661|OTHER|Treatment comparison (MK-8521 125μg - placebo) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 125μg vs. placebo was calculated from the model.|Geometric mean ratio|4.61|||<|0.001|TWO_SIDED|90.0|3.69|5.76|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|5.76|3.69|<0.001
74080864|NCT02055547|147713661|OTHER|Treatment comparison (MK-8521 35μg - placebo) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 35μg vs. placebo was calculated from the model.|Geometric mean ratio|2.67|||<|0.001|TWO_SIDED|90.0|2.12|3.36|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|3.36|2.12|<0.001
73836255|NCT04000724|147221586|SUPERIORITY||Average treatment effect|-0.24||||0.127|TWO_SIDED|95.0|-0.56|0.07|||Longitudinal Targeted Maximum Likelihood|||||.07|-.56|.127
73836256|NCT04000724|147221586|SUPERIORITY||Average treatment effect|-0.02||||0.899|TWO_SIDED|95.0|-0.34|0.3|||Longitudinal Targeted Maximum Likelihood|||||.30|-.34|.899
73958894|NCT03923491|147453378|SUPERIORITY||Slope|0.83|STANDARD_ERROR_OF_MEAN|1.1||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 whole grain component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.0
74080865|NCT02055547|147713661|OTHER|"Treatment comparison (MK-8521 125μg - MK-8521 35μg) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 125μg vs.~MK-8521 35μg was calculated from the model."|Geometric mean ratio|1.73|||<|0.001|TWO_SIDED|90.0|1.38|2.16|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|2.16|1.38|<0.001
74080866|NCT02055547|147713662|OTHER|Treatment comparison (MK-8521 125μg - placebo) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 125μg vs. placebo was calculated from the model.|Geometric mean ratio|3.04|||<|0.001|TWO_SIDED|90.0|2.62|3.53|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|3.53|2.62|<0.001
74080867|NCT02055547|147713662|OTHER|Treatment comparison (MK-8521 35μg - placebo) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 35μg vs. placebo was calculated from the model.|Geometric mean ratio|1.94|||<|0.001|TWO_SIDED|90.0|1.67|2.26|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|2.26|1.67|<0.001
74080868|NCT02055547|147713662|OTHER|Treatment comparison (MK-8521 125μg - 35μg) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 125μg - 35μg was calculated from the model.|Geometric mean ratio|1.57|||<|0.001|TWO_SIDED|90.0|1.35|1.82|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|1.82|1.35|<0.001
74080869|NCT02055547|147713663|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125mcg - placebo) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.65|||<|0.001|TWO_SIDED|90.0|0.6|0.7|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.7|0.6|<0.001
73836257|NCT00567112|147221619|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|TWO_SIDED|90.0|0.92|1.05|||ANOVA|||OCT (fasted)/DFC (fasted)||1.05|0.92|>0.200
73836258|NCT00567112|147221620|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|TWO_SIDED|90.0|0.8|1.19|||ANOVA|||OCT (fasted)/DFC (fasted)||1.19|0.80|>0.200
73836259|NCT00567112|147221621|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.92||||0.026|TWO_SIDED|90.0|0.86|0.98|||ANOVA|||OCT (after meal)/OCT (fasted)||0.98|0.86|0.026
74080870|NCT02055547|147713663|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 35μg - placebo) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.74|0.87|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.87|0.74|<0.001
74080871|NCT02055547|147713663|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg - MK-8521 35μg) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.81|||<|0.001|TWO_SIDED|90.0|0.75|0.87|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.87|0.75|<0.001
74080872|NCT02055547|147713664|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg vs. placebo) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.55|||<|0.001|TWO_SIDED|90.0|0.49|0.63|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.63|0.49|<0.001
74080873|NCT02055547|147713664|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 35μg - placebo) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.71|||<|0.001|TWO_SIDED|90.0|0.62|0.81|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.81|0.62|<0.001
74080874|NCT02055547|147713664|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg - MK-8521 35μg) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.78||||0.004|TWO_SIDED|90.0|0.69|0.89|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.89|0.69|0.004
74080875|NCT01822119|147713670|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation|||||||<0.0001
74080876|NCT01822119|147713671|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation|||||||<0.0001
74080877|NCT01822119|147713672|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Statistically significant changes with the same value at 500 to 4000Hz||||<0.0001
74080878|NCT01822119|147713672|SUPERIORITY_OR_OTHER|||||||0.0499|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Change at 6000Hz||||0.0499
74080879|NCT01822119|147713672|SUPERIORITY_OR_OTHER|||||||0.0632|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Change at 8000Hz||||0.0632
74080880|NCT01822119|147713673|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||0.39
74080881|NCT01822119|147713674|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||500Hz||||0.79
74080882|NCT01822119|147713674|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||1000Hz||||0.26
74080883|NCT01822119|147713674|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||2000Hz||||0.24
74080884|NCT01822119|147713674|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||3000Hz||||0.83
74080885|NCT01822119|147713674|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||4000Hz||||0.026
74080886|NCT01822119|147713674|SUPERIORITY_OR_OTHER|||||||0.0085|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6000Hz||||0.0085
74080887|NCT01822119|147713674|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||8000Hz||||0.13
74080888|NCT01822119|147713675|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Statistically significant improvement with the same value at all presentation levels.||||<0.0001
74080889|NCT01822119|147713676|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||50dB||||0.55
73958895|NCT03923491|147453378|SUPERIORITY||Slope|-0.9|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total dairy component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.0
74080890|NCT01822119|147713676|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||60dB||||0.72
74080891|NCT01822119|147713676|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||80dB||||0.28
74080892|NCT01822119|147713677|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||<0.0001
74080893|NCT01822119|147713678|SUPERIORITY_OR_OTHER|||||||0.0092|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||0.0092
74080894|NCT01822119|147713679|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Aversiveness||||0.59
74080895|NCT01822119|147713679|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Ease of Communication||||0.71
74080896|NCT01822119|147713679|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Reverberation||||0.59
74080897|NCT01822119|147713679|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Background noise||||0.40
74080898|NCT01822119|147713679|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Global score||||0.50
74080899|NCT01248728|147713750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
74080900|NCT01248728|147713751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
74080901|NCT01248728|147713753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
74080902|NCT01248728|147713754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Regression, Linear|||||||0.6
74080903|NCT01838681|147713777|SUPERIORITY||Odds Ratio (OR)|0.83||||0.2641|TWO_SIDED|95.0|0.6|1.15|||Regression, Logistic|Model included MADRS total score at the randomisation visit, treatment group, country, and the randomisation criteria used||||1.15|0.60|0.2641
74080904|NCT01229150|147713795|SUPERIORITY_OR_OTHER|||||||0.24|||||||Log Rank|||||||0.24
74080905|NCT01229150|147713795|SUPERIORITY_OR_OTHER|||||||0.75|||||||Log Rank|||||||0.75
74080906|NCT01229150|147713799|SUPERIORITY_OR_OTHER|||||||0.51|||||||Log Rank|||||||0.51
74080907|NCT01229150|147713799|SUPERIORITY_OR_OTHER|||||||0.81|||||||Log Rank|||||||0.81
74080908|NCT01229150|147713801|SUPERIORITY_OR_OTHER||||||<|0.0007||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 2.|Wilcoxon matched-pairs signed rank test|||||||<0.0007
74080909|NCT01229150|147713801|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 14.|Wilcoxon matched-pairs signed rank test|||||||<0.0001
74080910|NCT01229150|147713801|SUPERIORITY_OR_OTHER|||||||0.0209||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 2 and cycle 1 day 14.|Wilcoxon matched-pairs signed rank test|||4 patients in this group; statistically underpowered.||||0.0209
74080911|NCT00902538|147713834|SUPERIORITY_OR_OTHER|||||||0.1187||95.0|||||ANCOVA|||||||0.1187
74080912|NCT00902538|147713834|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74080913|NCT00902538|147713835|SUPERIORITY_OR_OTHER|||||||0.0425||95.0|||||ANCOVA|||||||0.0425
74080914|NCT00902538|147713835|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74080915|NCT00902538|147713836|SUPERIORITY_OR_OTHER|||||||0.1939||95.0|||||Cochran-Mantel-Haenszel|||||||0.1939
74080916|NCT00902538|147713836|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
74080917|NCT00902538|147713837|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|||||||0.0009
74080918|NCT00902538|147713837|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74080919|NCT00902538|147713838|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
74080920|NCT00902538|147713838|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74080921|NCT00902538|147713839|SUPERIORITY_OR_OTHER|||||||0.1611||95.0|||||ANCOVA|||||||0.1611
74080922|NCT00902538|147713840|SUPERIORITY_OR_OTHER|||||||0.0451||95.0|||||ANCOVA|||||||0.0451
74080923|NCT00902538|147713841|SUPERIORITY_OR_OTHER|||||||0.0412||95.0|||||ANCOVA|||||||0.0412
74080924|NCT00902538|147713842|SUPERIORITY_OR_OTHER|||||||0.0253||95.0|||||ANCOVA|||||||0.0253
74080925|NCT00902538|147713843|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||ANCOVA|||||||0.0063
74080926|NCT00849797|147713850|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|90.86||||||90.0|85.47|96.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.60|85.47|
74080927|NCT00849797|147713851|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|96.59|100.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.66|96.59|
74080928|NCT00849797|147713852|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.74||||||90.0|96.71|100.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.80|96.71|
74080929|NCT00849797|147713853|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.5||||||90.0|95.66|100.48|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||100.48|95.66|
74080930|NCT00849797|147713854|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.29||||||90.0|98.96|101.64|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.|||101.64|98.96|
74080931|NCT00849797|147713855|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.08||||||90.0|98.91|101.27|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||101.27|98.91|
74080932|NCT00926887|147713864|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
74080933|NCT00926887|147713867|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|t=-2.711; df=102; p\<0.01||||||<0.01
74080934|NCT00926887|147713871|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|df=102, t=-3.44||||||<0.001
74080935|NCT04198363|147713874|NON_INFERIORITY|Noninferiority of vonoprazan to esomeprazole was evaluated by Farrington and Manning test using a noninferiority margin of 10% for analysis.|Difference in Proportions|0.1|||=|0.0009|TWO_SIDED|95.0|-5.95|6.17|||Farrington and Manning Test||Difference in proportions for vonoprazan versus esomeprazole was analyzed and the 2-sided Wald confidence interval was used for determining the 95% confidence interval.|||6.17|-5.95|=0.0009
74080936|NCT03067987|147713885|SUPERIORITY||||||<|0.007|||||||ANOVA|||||||<0.007
74080937|NCT03067987|147713886|SUPERIORITY|||||||0.0006|||||||ANOVA|||||||0.0006
74080938|NCT03442322|147713889|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.25||||0.492|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.492
74080939|NCT03442322|147713890|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.73||||0.765|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.765
74080940|NCT03442322|147713891|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|0.77||||0.808|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.808
74080941|NCT03442322|147713892|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|3.86||||0.108|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.108
74080942|NCT03442322|147713893|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|2.59||||0.411|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.411
74080943|NCT03442322|147713894|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.08||||0.981|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.981
74080944|NCT03442322|147713895|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|3.51||||0.02|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.020
74080945|NCT03442322|147713896|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.62||||0.299|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.299
74080946|NCT03442322|147713897|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.68||||0.389|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.389
74080947|NCT03442322|147713898|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.14||||0.389|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.389
74080948|NCT03442322|147713899|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-5.95||||0.043|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.043
73836260|NCT00567112|147221622|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.59|||<|0.001|TWO_SIDED|90.0|0.49|0.72|||ANOVA|||OCT (after meal)/OCT (fasted)||0.72|0.49|<0.001
73958896|NCT03923491|147453378|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.42||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total protein foods component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
73958897|NCT03923491|147453378|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.85||-0.12|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 seafood and plant protein component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||-0.12
74080949|NCT03442322|147713900|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.91||||0.279|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.279
74080950|NCT03442322|147713901|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|0.92||||0.728|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.728
74080951|NCT03442322|147713902|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-1.75||||0.49|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.490
74080952|NCT03442322|147713903|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|4.44||||0.232|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.232
74080953|NCT03442322|147713904|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.11||||0.708|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.708
74080954|NCT03442322|147713905|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.0||||0.775|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.775
73836261|NCT00567112|147221623|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||ANOVA|||OCT (fasted)/DFC (fasted)||||>0.200
73836262|NCT00567112|147221624|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||ANOVA|||OCT (fasted)/DFC (fasted)||||>0.200
73836263|NCT00567112|147221625|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||OCT (after meal)/OCT (fasted)||||<0.001
73836264|NCT00567112|147221626|SUPERIORITY_OR_OTHER||||||>|0.2|||||||ANOVA|||OCT (after meal)/OCT (fasted)||||>0.200
73836265|NCT03467945|147221642|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.4421|||||TWO_SIDED|90.0|75.2805|88.1079||||||||88.1079|75.2805|
73836266|NCT03467945|147221642|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
73836267|NCT03467945|147221642|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||TWO_SIDED|90.0|74.8823|87.6417||||||||87.6417|74.8823|
73836268|NCT03467945|147221643|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
73836269|NCT03467945|147221643|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.7255|||||TWO_SIDED|90.0|101.1665|110.49||||||||110.4900|101.1665|
73836270|NCT03467945|147221643|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.7533|||||TWO_SIDED|90.0|92.5812|101.1135||||||||101.1135|92.5812|
73836271|NCT03467945|147221644|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|77.6923|||||TWO_SIDED|90.0|70.383|85.7606||||||||85.7606|70.3830|
74080955|NCT03442322|147713906|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.77||||0.584|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.584
73836272|NCT03467945|147221644|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||TWO_SIDED|90.0|102.237|114.2609||||||||114.2609|102.2370|
73836273|NCT03467945|147221644|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|79.4367|||||TWO_SIDED|90.0|71.9633|87.6861||||||||87.6861|71.9633|
73836274|NCT03467945|147221645|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||TWO_SIDED|90.0|102.237|114.2609||||||||114.2609|102.2370|
73836275|NCT03467945|147221645|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|93.6828|||||TWO_SIDED|90.0|88.6166|99.0386||||||||99.0386|88.6166|
73836276|NCT03467945|147221645|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|115.37|||||TWO_SIDED|90.0|109.131|121.9658||||||||121.9658|109.1310|
73836277|NCT03467945|147221646|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|82.6022|||||TWO_SIDED|90.0|76.5513|89.1314||||||||89.1314|76.5513|
73836278|NCT03467945|147221646|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
73836279|NCT03467945|147221646|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||TWO_SIDED|90.0|74.8823|87.6417||||||||87.6417|74.8823|
73836280|NCT03467945|147221647|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||TWO_SIDED|90.0|97.5947|106.2906||||||||106.2906|97.5947|
73836281|NCT03467945|147221647|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.915|||||TWO_SIDED|90.0|101.49|110.533||||||||110.5330|101.4900|
73836282|NCT03467945|147221647|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.1619|||||TWO_SIDED|90.0|92.1443|100.3546||||||||100.3546|92.1443|
73836283|NCT03520387|147221679|SUPERIORITY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-10.2|3.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with LRFA over simulated LRFA.|||3.7|-10.2|
73836284|NCT03520387|147221679|SUPERIORITY||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-11.0|-1.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with AcTIVE-CBT over TBSCE.|||-1.6|-11.0|
73836285|NCT03520387|147221680|SUPERIORITY||Mean Difference (Final Values)|-6059.0|STANDARD_ERROR_OF_MEAN|2832.7|||TWO_SIDED|95.0|-12467.0|349.1|||||This is an analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on CHANGE in step counts, after adjustment for age and baseline step counts. Positive values show increased steps with LRFA over simulated LRFA.|||349.1|-12467.0|
73836286|NCT03520387|147221680|SUPERIORITY||Mean Difference (Final Values)|2081.9|STANDARD_ERROR_OF_MEAN|2983.2|||TWO_SIDED|95.0|-4666.6|8830.4|||||This is an analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on CHANGE in step counts, after adjustment for age and baseline step counts.Positive values show increased steps with AcTIVE-CBT over TBSCE.|||8830.4|-4666.6|
73897621|NCT01106092|147328312|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.78||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.78|-4.78|
73836287|NCT03520387|147221681|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|95.0|-5.2|3.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with LRFA over simulated LRFA.|||3.1|-5.2|
73958898|NCT03923491|147453378|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|1.12||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 fatty acid component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
73836288|NCT03520387|147221681|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-4.2|3.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with AcTIVE-CBT over TBSCE.|||3.6|-4.2|
73836289|NCT03520387|147221682|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-8.1|10.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with LRFA vs. simulated LRFA.|PROMIS physical health scores||10.1|-8.1|
73836290|NCT03520387|147221682|SUPERIORITY||Mean Difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-0.4|12.9|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE|PROMIS physical health scores||12.9|-0.4|
73836291|NCT03520387|147221682|SUPERIORITY||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.4|12.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with LRFA vs. simulated LRFA.|PROMIS mental health scores||12.7|-5.4|
73836292|NCT03520387|147221682|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-7.0|10.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE|PROMIS mental health scores||10.6|-7.0|
73836293|NCT03520387|147221683|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-7.7|1.9|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate lower doses with LRFA over simulated LRFA.|||1.9|-7.7|
73836294|NCT03520387|147221683|SUPERIORITY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-7.5|1.0|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate lower doses with AcTIVE-CBT over TBSCE.|||1.0|-7.5|
74020445|NCT01751971|147593256|SUPERIORITY||Mean Difference (Net)|10.5||||0.4|TWO_SIDED|95.0|-16.0|37.1|||t-test, 2 sided||Positive estimated value would represent a greater reduction in AHI with oxygen (% sham) in the high vs low loop gain group.|"Primary statistical comparison was the percent reduction in AHI----\[AHI(sham)-AHI(oxygen)\]/AHI(sham) %----between two phenotypic patient subgroups. Patient subgroups were defined by the loop gain (LG1) measured on the sham night as high or low (a priori cutoff LG1=0.7)."||37.1|-16|0.4
73836295|NCT03520387|147221684|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.4|1.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate perceived benefit with LRFA over simulated LRFA.|||1.7|-1.4|
73836296|NCT03520387|147221684|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.3|1.5|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Positive scores indicate perceived benefit with AcTIVE-CBT over TBSCE.|||1.5|-1.3|
73836297|NCT03520387|147221685|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-5.5|3.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Negative scores indicate less pain with LRFA over simulated LRFA.|||3.7|-5.5|
73836298|NCT03520387|147221685|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|95.0|-5.4|2.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Negative scores indicate less pain with AcTIVE-CBT vs. TBSCE|||2.6|-5.4|
73836299|NCT03520387|147221686|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-0.5|3.0|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate more satisfaction with LRFA over simulated LRFA.|||3.0|-0.5|
73836300|NCT03520387|147221686|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-0.4|2.8|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE.|||2.8|-0.4|
74080956|NCT03442322|147713907|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.25||||0.898|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.898
73836301|NCT03520387|147221687|SUPERIORITY||Mean Difference (Final Values)|-637.0|STANDARD_ERROR_OF_MEAN|433.3|||TWO_SIDED|95.0|-1636.2|362.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months adjusting for age and baseline value of the outcome. Positive scores indicate greater activity with LRFA over simulated LRFA.|||362.1|-1636.2|
73836302|NCT03520387|147221687|SUPERIORITY||Mean Difference (Final Values)|572.2|STANDARD_ERROR_OF_MEAN|334.5|||TWO_SIDED|95.0|-199.3|1343.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months adjusting for age and baseline value of the outcome. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE.|||1343.6|-199.3|
73930693|NCT03238911|147391292|SUPERIORITY||Mean Difference (Final Values)|32.22|||<|0.0001|TWO_SIDED|95.0|25.49|38.96|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||38.96|25.49|<0.0001
74020446|NCT01751971|147593256|SUPERIORITY||Mean Difference (Final Values)|17.4|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|10.7|24.1|||t-test, 2 sided||Direction of comparison: Positive estimation parameter would indicate lower AHI on oxygen versus sham.|Here we aimed to confirm that there was a difference between AHI on oxygen vs sham (overall, i.e. in unselected patients). This test, however was not part of our primary objective.||24.1|10.7|<0.001
74020447|NCT01751971|147593256|SUPERIORITY||Mean Difference (Net)|42.8||||0.001|TWO_SIDED|95.0|21.0|64.6|||t-test, 2 sided||Direction of comparison: Positive estimated value would indicate a greater percentage reduction in AHI (oxygen vs. sham) in favorable vs. unfavorable subgroups.|"The primary goal of the study was to identify a phenotypic subgroup of patients with sleep apnea that responds preferentially to oxygen (percent reduction in AHI----\[AHI(sham)-AHI(oxygen)\]/AHI(sham) %). We defined patient subgroups (favorable versus unfavorable) based on the four key phenotypic traits (loop gain, collapsibility, arousal threshold, muscle responses) measured on the sham night, with the use of multiple logistic regression and leave-one-out cross validation."||64.6|21.0|0.001
74020448|NCT01649947|147593274|OTHER||Mean Difference (Net)|56.0||||0.01|TWO_SIDED|95.0|8.9|72.0|||t-test, 2 sided|||The analysis is comprised of evaluable patients who had measureable disease and received at least one cycle of therapy and had disease evaluated.||72|8.9|0.01
74080957|NCT03442322|147713908|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.79||||0.217|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.217
73836303|NCT03336866|147221688|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73958899|NCT03923491|147453378|SUPERIORITY||Slope|-2.09|STANDARD_ERROR_OF_MEAN|0.97||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 sodium component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
73958900|NCT03923491|147453378|SUPERIORITY||Slope|-0.8|STANDARD_ERROR_OF_MEAN|1.16||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 refined grains component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
73958901|NCT03923491|147453378|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|1.13||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 added sugar component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
73958902|NCT03923491|147453378|SUPERIORITY||Slope|-0.52|STANDARD_ERROR_OF_MEAN|0.86||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||||||1.00
73958903|NCT02633358|147453381|SUPERIORITY|Therapeutic hypothermia need to have superiority in the survival rate after 90 days|Risk Ratio (RR)|0.58|||<|0.001|TWO_SIDED|95.0|0.41|0.82||P-value less than 0.05 means significant data|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group||0.82|0.41|<0.001
73958904|NCT02633358|147453382|SUPERIORITY|Therapeutic hypothermia nee to have superiority in neurological outcome in the 90 days after enrollment.|Risk Ratio (RR)|0.8||||0.04|TWO_SIDED|95.0|0.66|0.98||P value less than 0.05 means significant date|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group||0.98|0.66|0.04
73958905|NCT02633358|147453383|SUPERIORITY||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
73958906|NCT02633358|147453384|SUPERIORITY||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
73958907|NCT02633358|147453385|SUPERIORITY||||||<|0.05||||||P-value less then 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
73958908|NCT00470106|147453482|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Not corrected for multiple comparisons because it is primary.|mixed model|same analysis as for secondary outcome variable.||||||<.001
73958909|NCT00470106|147453483|SUPERIORITY_OR_OTHER||||||<|0.1||||||A priori threshold for significance was P \< .05|mixed model|Same as for the primary variable.||||||<.10
73958910|NCT03621761|147453484|SUPERIORITY||Slope|1.774||||0.3451|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on total MFIS score, in linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline MFIS score. Output reflects models that were imputed for missing data.||||0.3451
73958911|NCT03621761|147453484|SUPERIORITY||Slope|1.3094||||0.4834|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on total MFIS score, in linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline MFIS score. Output reflects models that were imputed for missing data.||||0.4834
73958912|NCT03621761|147453485|SUPERIORITY||Slope|0.4077||||0.257|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in EMA fatigue intensity NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue intensity score.||||0.2570
74020449|NCT00364182|147593276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.5|||<|0.0001|TWO_SIDED|95.0|-36.5|-24.5||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||-24.5|-36.5|<0.0001
73836304|NCT03336866|147221688|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73958913|NCT03621761|147453485|SUPERIORITY||Slope|-0.2452||||0.5017|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in EMA fatigue intensity NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue intensity score.||||0.5017
73958914|NCT03621761|147453486|SUPERIORITY||Slope|0.095||||0.154|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in EMA fatigue interference NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue interference score.||||0.154
73958915|NCT03621761|147453486|SUPERIORITY||Slope|0.034||||0.61|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in EMA fatigue interference NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue interference score.||||0.610
73958916|NCT03621761|147453487|SUPERIORITY||Slope|0.00427||||0.4955|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in fatigability score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline fatigability score.||||0.4955
73958917|NCT03621761|147453487|SUPERIORITY||Slope|-0.00948||||0.1333|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in fatigability score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline fatigability score.||||0.1333
73958918|NCT03951649|147453497|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
73958919|NCT03951649|147453498|SUPERIORITY||||||>|0.99||||||The p-value was calculated using a 2 sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||||||>0.99
73958920|NCT03951649|147453499|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
73958921|NCT03951649|147453500|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
73958922|NCT03951649|147453501|SUPERIORITY|||||||1||||||P-value was calculated|Fisher Exact|||||||1.00
73958923|NCT03951649|147453502|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
73958924|NCT03951649|147453503|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
73958925|NCT03951649|147453505|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
73958926|NCT03951649|147453506|SUPERIORITY|||||||0.18|||||||Fisher Exact|||||||0.18
73958927|NCT03951649|147453507|SUPERIORITY|||||||0.92|||||||Fisher Exact|||||||0.92
73958928|NCT03951649|147453508|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
73958929|NCT03951649|147453509|SUPERIORITY|||||||0.14|||||||Fisher Exact|||||||0.14
73958930|NCT03951649|147453510|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
73958931|NCT00758602|147453522|SUPERIORITY_OR_OTHER||LS Mean difference|0.6581||||0.0813|TWO_SIDED|95.0|-0.08|1.4||p-value, least squares (LS) mean difference, and 95% confidence interval (CI) based on analysis of covariance (ANCOVA) model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA|||||1.40|-0.08|0.0813
73958932|NCT00758602|147453523|SUPERIORITY_OR_OTHER||LS Mean difference|-1.5977||||0.7949|TWO_SIDED|95.0|-13.77|10.58||p-value, LS mean difference, and 95% CI based on ANCOVA model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA|||||10.58|-13.77|0.7949
73958933|NCT00758602|147453524|SUPERIORITY_OR_OTHER|||||||0.6812|||||||Fisher Exact|||Acute rejection, 6 months post-transplant||||0.6812
73958934|NCT00758602|147453524|SUPERIORITY_OR_OTHER|||||||0.6812|||||||Fisher Exact|||Acute rejection, 12 months post-transplant||||0.6812
73958935|NCT00758602|147453524|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Death, 12 months post-transplant||||1.0000
73958936|NCT00758602|147453526|SUPERIORITY_OR_OTHER|||||||1|||||||Log Rank|||||||1.0000
73958937|NCT00758602|147453527|SUPERIORITY_OR_OTHER|||||||0.4586|||||||Fisher Exact|||||||0.4586
73958938|NCT00758602|147453528|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73958939|NCT00392678|147453550|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
73958940|NCT00038103|147453557|SUPERIORITY_OR_OTHER||Clinical Benefit Rate|49.0||||||95.0|34.4|63.7|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.|||63.7|34.4|
73958941|NCT00038103|147453557|SUPERIORITY_OR_OTHER||Clinical Benefit Rate|47.1||||||95.0|32.9|61.5|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.|||61.5|32.9|
73958942|NCT00038103|147453558|SUPERIORITY_OR_OTHER||Objective Response Rate|22.4||||||95.0|11.8|36.6|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.|||36.6|11.8|
73958943|NCT00038103|147453558|SUPERIORITY_OR_OTHER||Objective Response Rate|23.5||||||95.0|12.8|37.5|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.|||37.5|12.8|
74020450|NCT00364182|147593276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.5|||<|0.0001|TWO_SIDED|95.0|-38.5|-26.6||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||-26.6|-38.5|<0.0001
74020451|NCT00364182|147593276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.2167|TWO_SIDED|95.0|-1.2|5.2||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||5.2|-1.2|0.2167
73836305|NCT03336866|147221688|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73836306|NCT03336866|147221688|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73836307|NCT03336866|147221688|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
74020452|NCT00364182|147593277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.002|TWO_SIDED|95.0|0.1|0.6|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.6|0.1|0.002
73836308|NCT03336866|147221688|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73836309|NCT03336866|147221688|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73836310|NCT03336866|147221688|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73971412|NCT04508309|147483480|NON_INFERIORITY|Non-inferiority of Cecolin at Months 0 and 6 (Group 1) compared to Gardasil at Months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.32|||||TWO_SIDED|95.0|1.07|1.635|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.635|1.070|
73836311|NCT03336866|147221689|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
74080958|NCT03442322|147713909|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-1.39||||0.56|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.560
74080959|NCT03442322|147713910|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.08||||0.277|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.277
74080960|NCT03442322|147713911|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.53||||0.4|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.400
74080961|NCT03442322|147713912|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.18||||0.303|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.303
74080962|NCT01404988|147713913|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||For this pilot study, the Type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||0.1
74080963|NCT01404988|147713913|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2
74080964|NCT01404988|147713914|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||.3
74080965|NCT01404988|147713914|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.77
74080966|NCT01404988|147713915|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||0.03
73971413|NCT05196919|147483488|SUPERIORITY||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|8.693||1|TWO_SIDED|95.0|-22.57|30.97|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||30.97|-22.57|1.00
74020453|NCT00364182|147593277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.021|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.8|0.1|0.021
74080967|NCT01404988|147713915|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.06
74080968|NCT01404988|147713916|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||For this pilot study, type 1 error was set at 5%|Fisher Exact|||||||0.60
74080969|NCT01404988|147713916|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Fisher Exact|||||||0.16
74080970|NCT00829764|147713917|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|93.52||||||90.0|88.49|98.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.83|88.49|
74080971|NCT00829764|147713918|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.75||||||90.0|93.98|101.67|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.67|93.98|
74080972|NCT00829764|147713919|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.46||||||90.0|94.78|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102.28|94.78|
74080973|NCT00199901|147713945|SUPERIORITY||Hazard Ratio (HR)|0.913|||||TWO_SIDED|95.0|0.532|1.568||||||||1.568|0.532|
74080974|NCT00199901|147713947|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.532|1.455||||||||1.455|0.532|
74080975|NCT00199901|147713948|SUPERIORITY||Hazard Ratio (HR)|0.911|||||TWO_SIDED|95.0|0.514|1.614||||||||1.614|0.514|
74080976|NCT05776901|147713956|OTHER|Descriptive statistics and measures of central tendency, including mean, median, and standard deviation of the System Usability Scores collected from the baseline and week 3 were computed. Then, a two-sided, paired sample t-test was conducted to evaluate the change in mean System Usability Scores from baseline at week 3.|Mean diff in SUS from baseline at week 3|34.17|STANDARD_ERROR_OF_MEAN|14.49|<|0.05|TWO_SIDED|95.0|-28.04|96.37|||t-test, 2 sided|||||96.37|-28.04|<0.05
74080977|NCT02997176|147713964|OTHER|Bioequivalence|Percent Ratio of Geometric Means|142.19|||||TWO_SIDED|90.0|79.92|252.98||||||AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.||252.98|79.92|
74080978|NCT02997176|147713964|OTHER|Bioequivalence|Percent Ratio of Geometric Means|110.54|||||TWO_SIDED|90.0|54.58|223.85||||||AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.||223.85|54.58|
73836312|NCT03336866|147221689|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73836313|NCT03336866|147221689|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73836314|NCT03336866|147221689|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73836315|NCT03336866|147221689|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73836316|NCT03336866|147221689|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73836317|NCT03336866|147221689|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
73836318|NCT04913675|147221700|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of 500 mg IM dose versus 500 mg IV using a non-inferiority margin of 3.5 percent (%) on the risk difference scale. A post-hoc weekly imputation algorithm imputes the missing outcome iteratively for each week, where missing outcomes at Day 8, 15, 22, 29 are imputed.|Risk Difference (RD)|1.06|||||TWO_SIDED|95.0|-1.15|3.26|||||Analysis was performed using a binomial regression model with identity link function and with treatment (Sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old) and gender (male, female) as covariates.|||3.26|-1.15|
73970920|NCT04103580|147481870|SUPERIORITY||Slope|-0.008|STANDARD_ERROR_OF_MEAN|0.004||0.049|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 2.||||0.049
73836319|NCT04913675|147221700|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of 500 mg IM vs 500 mg IV using a non-inferiority margin of 3.5 percent (%) on the risk difference scale. A pre-specified daily imputation algorithm imputed the missing outcome iteratively for each study day starting with Day 2 and ending at Day 29.|Risk Difference (RD)|1.16|||||TWO_SIDED|95.0|-1.23|3.56|||||Analysis was performed using a binomial regression model with identity link function and with treatment (Sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old) and gender (male, female) as covariates.|||3.56|-1.23|
73836320|NCT04913675|147221718|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of IM dose versus IV using a non-inferiority margin of 3.5% on the risk difference scale. Weekly imputation algorithm imputes the missing outcome iteratively for each week, where missing outcomes at Day 8, 15, 22, 29 are imputed.|Risk Difference (RD)|0.86|||||TWO_SIDED|95.0|-1.56|3.28|||||Post-hoc analysis was performed using a binomial regression model with identify link function and with treatment (Sotrovimab 500 mg IM, 500 mg IV), age (\<65, \>-65 years old), and sex (male, female) as covariates.|||3.28|-1.56|
73836321|NCT04913675|147221721|EQUIVALENCE|IM dose was assessed for equivalence to IV based on the two-sided 90% confidence interval for the treatment ratio falling within equivalence bounds of 0.5 to 2.0.|Ratio of least square(LS) geometric mean|1.04|||||TWO_SIDED|90.0|1.0|1.07|||||LS geometric mean was calculated for 500mg IV versus IM by using an Analysis of Covariance (ANCOVA) Model with treatment group (sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old), gender (male, female) and Baseline viral load as covariates.|||1.07|1.00|
73836322|NCT01740427|147221798|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.576|||<|1e-06|TWO_SIDED|95.0|0.463|0.718||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||0.718|0.463|<0.000001
73836323|NCT01740427|147221799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.428||||0.0224|TWO_SIDED|95.0|1.008|2.03||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.||2.030|1.008|0.0224
73836324|NCT01740427|147221800|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.594||||0.009|TWO_SIDED|95.0|1.08|2.347||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.||2.347|1.080|0.0090
73836325|NCT01740427|147221802|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.451|||<|0.0001|TWO_SIDED|95.0|1.619|3.722||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral, non-visceral) per randomization.||3.722|1.619|<0.0001
73836326|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.571|||<|0.0001|TWO_SIDED|95.0|0.443|0.737|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER positive||0.737|0.443|<0.0001
73836327|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.405||||0.003|TWO_SIDED|95.0|0.218|0.751|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER Negative||0.751|0.218|0.0030
73836328|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.531|||<|0.0001|TWO_SIDED|95.0|0.416|0.68|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Positive||0.680|0.416|<0.0001
73836329|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.675||||0.3237|TWO_SIDED|95.0|0.308|1.481|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Negative||1.481|0.308|0.3237
73836330|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.555|||<|0.0001|TWO_SIDED|95.0|0.437|0.705|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Positive||0.705|0.437|<0.0001
73836331|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.997||||0.9964|TWO_SIDED|95.0|0.287|3.461|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Negative||3.461|0.287|0.9964
73836332|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.518|||<|0.0001|TWO_SIDED|95.0|0.4|0.67|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Positive||0.670|0.400|<0.0001
73836333|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.731||||0.3221|TWO_SIDED|95.0|0.392|1.364|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Negative||1.364|0.392|0.3221
73836334|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.581|||<|0.0001|TWO_SIDED|95.0|0.455|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore\<175||0.742|0.455|<0.0001
73836335|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.255||||0.0022|TWO_SIDED|95.0|0.1|0.65|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore\>=175||0.650|0.100|0.0022
73836336|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.379|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 \<=20%||0.742|0.379|0.0002
73836337|NCT01740427|147221803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.569||||0.0007|TWO_SIDED|95.0|0.409|0.791|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 \>20%||0.791|0.409|0.0007
73836338|NCT01740427|147221807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.023||||0.0925|TWO_SIDED|95.0|-0.004|0.051|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||||0.051|-0.004|0.0925
73836339|NCT01740427|147221808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.325||||0.7822|TWO_SIDED|95.0|-2.63|1.98|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||||1.98|-2.63|0.7822
73836340|NCT01740427|147221810|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.956||||0.33775|TWO_SIDED|95.0|0.777|1.177||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||1.177|0.777|0.337750
73836341|NCT01740427|147221811|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.921||||0.208706|TWO_SIDED|95.0|0.755|1.124||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||1.124|0.755|0.208706
73836342|NCT02405962|147221820|SUPERIORITY||Adjusted Incidence Rate Ratio|0.2|||<|0.05|TWO_SIDED|95.0|0.08|0.53|||Mixed Models Analysis|||||0.53|0.08|<0.05
73836343|NCT01107457|147221836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079|TWO_SIDED||||||Fisher Exact|||||||0.079
73836344|NCT01107457|147221836|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73836345|NCT01107457|147221836|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73836346|NCT01107457|147221836|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73836347|NCT01107457|147221837|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73836348|NCT01107457|147221837|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73836349|NCT01107457|147221837|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73836350|NCT01107457|147221837|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73836351|NCT00086307|147221872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.826|STANDARD_ERROR_OF_MEAN|2.296||0.018|TWO_SIDED|95.0|1.111|12.541||This is the omnibus effect of drug.|Mixed Models Analysis|||A linear mixed model with restricted maximum likelihood estimation and a first order autoregressive covariance structure was used to examine depressive symptoms over time. Fixed factors for drug, time, and a time by drug interaction were included in the model along with the intercept. No random factors were included because the subject factor did not contribute significantly to the model. Baseline symptoms were used as a covariate.||12.541|1.111|.018
73836352|NCT00086307|147221872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.826|STANDARD_ERROR_OF_MEAN|2.296||0.014|TWO_SIDED|95.0|1.111|12.541||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the pramipexole and escitalopram combination group.||12.541|1.111|.014
73836353|NCT00086307|147221872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.353|STANDARD_ERROR_OF_MEAN|2.296||0.454|TWO_SIDED|95.0|-2.36|9.066||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The escitalopram group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the escitalopram group to the pramipexole and escitalopram combination group.||9.066|-2.360|.454
73836354|NCT00086307|147221872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.473|STANDARD_ERROR_OF_MEAN|2.162||0.349|TWO_SIDED|95.0|-1.942|8.888||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the escitalopram group.||8.888|-1.942|.349
73836355|NCT06765889|147221889|OTHER||Bayes Factor (BF₁₀)|0.03|||||TWO_SIDED|||||||||||||
73836356|NCT06765889|147221892|OTHER||Mean (of both conditions)|4.17|||||TWO_SIDED|||||||||||||
73836357|NCT04193176|147221896|SUPERIORITY||Mean Difference (Net)|-11.67||||0.004|TWO_SIDED|95.0|-19.67|-3.67|||ANCOVA|||||-3.67|-19.67|0.004
73836358|NCT02370394|147221899|SUPERIORITY||Mean Difference (Final Values)|-4.14||||0.4016|TWO_SIDED|95.0|-14.02|5.75|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||CAS Victimization Total Score at Follow Up||5.75|-14.02|0.4016
73836359|NCT02370394|147221899|SUPERIORITY||Mean Difference (Net)|14.46||||0.0072|TWO_SIDED|95.0|4.11|24.82|||t-test, 2 sided|||Change in CAS Victimization Total score from Baseline to Follow Up||24.82|4.11|0.0072
73836360|NCT02370394|147221900|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6011|TWO_SIDED|95.0|-0.21|0.12|||t-test, 2 sided|||Safety Behavior Change Score at Follow Up||0.12|-0.21|0.6011
73836361|NCT02370394|147221900|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9116|TWO_SIDED|95.0|-0.16|0.15|||t-test, 2 sided|||Change is Safety Behavior Change Score from Baseline to Follow Up||0.15|-0.16|0.9116
73836362|NCT02370394|147221901|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.8646|TWO_SIDED|95.0|-1.62|1.36|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||EOR Number of issues Effective at Accomplishing at Follow Up||1.36|-1.62|0.8646
73836363|NCT02370394|147221901|SUPERIORITY||Mean Difference (Net)|-0.86||||0.3045|TWO_SIDED|95.0|-2.54|0.82|||t-test, 2 sided|||Change in Number of Issues Effective at Accomplishing from Baseline to Follow Up||0.82|-2.54|0.3045
73836364|NCT02370394|147221902|SUPERIORITY|||||||0.9085|||||||Wilcoxon (Mann-Whitney)|||Motivation Scale at Follow Up||||0.9085
73836365|NCT02370394|147221902|SUPERIORITY|||||||0.3256|||||||Wilcoxon (Mann-Whitney)|||Change in Motivation Scale from Baseline to Follow Up||||0.3256
73836366|NCT02370394|147221903|SUPERIORITY|||||||0.4085|||||||Wilcoxon (Mann-Whitney)|||Readiness at Follow Up||||0.4085
73836367|NCT02370394|147221903|SUPERIORITY|||||||0.2467|||||||Wilcoxon (Mann-Whitney)|||Change in Readiness from Baseline to Follow Up||||0.2467
73836368|NCT00908388|147221923|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||(1-Posterior probability of meeting performance goal given the data)|Bayesian adaptive|||||||.006
73836369|NCT00337194|147221935|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Chi-squared|||||||0.06
73836370|NCT00337194|147221936|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
73971414|NCT05196919|147483488|SUPERIORITY||Mean Difference (Final Values)|7.96|STANDARD_ERROR_OF_MEAN|8.142||0.99|TWO_SIDED|95.0|-17.12|33.03|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||33.03|-17.12|0.99
73836371|NCT01623752|147221961|OTHER|||||||0.278|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.278
73836372|NCT01623752|147221961|OTHER|||||||0.222|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.222
73836373|NCT01623752|147221962|OTHER|||||||0.251|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.251
73836374|NCT01623752|147221962|OTHER|||||||0.218|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.218
73836375|NCT01623752|147221965|OTHER|||||||0.675|||||||Regression, Linear|||||||0.675
73836376|NCT01623752|147221965|OTHER|||||||0.357|||||||Regression, Linear|||||||0.357
73836377|NCT01623752|147221966|OTHER|||||||0.106|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.106
73836378|NCT01623752|147221966|OTHER|||||||0.181|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.181
73836379|NCT01623752|147221967|OTHER|||||||0.015|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.015
73836380|NCT01623752|147221967|OTHER|||||||0.969|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.969
73836381|NCT01623752|147221968|OTHER|||||||0.489|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.489
73836382|NCT01623752|147221968|OTHER|||||||0.386|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.386
73836383|NCT01623752|147221969|OTHER|||||||0.364|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.364
73836384|NCT01623752|147221969|OTHER|||||||0.849|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.849
73836385|NCT00564070|147222005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.2|||<|0.0001|TWO_SIDED|95.0|17.37|42.9|||Mixed Models Analysis|General linear model, controlling for baseline values|The Mean Difference was calculated as percent adherence to glucose monitoring for the CBT-AD Arm minus the adherence to glucose monitoring for the Enhanced Treatment as Usual Arm.|Multiple imputation was used to handle missing data; analyses are reported for the acute outcomes of glucose monitoring (i.e., 4 month)||42.9|17.37|<.0001
73836386|NCT00564070|147222006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|||=|0.001|TWO_SIDED|95.0|0.29|1.15|||ANCOVA|General linear model; Controlling for baseline values|The Mean Difference was calculated as percent of HbA1c for the Enhanced Treatment as Usual Arm minus percent of HbA1c for the CBT-AD Arm.|Multiple imputation was used to handle missing data; results are reported for HbA1c at the acute outcome (i.e., 4 months)||1.15|.29|=.001
73836387|NCT00564070|147222007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.22|31.14|||Mixed Models Analysis||The Mean Difference was calculated as percent pill adherence via MEMs for the CBT-AD Arm minus the percent pill adherence for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of MEMs monitoring (4 month). Higher percentages represent better adherence.||31.14|10.22|<0.0001
73836388|NCT00564070|147222008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||=|0.002|TWO_SIDED|95.0|2.33|10.56|||Mixed Models Analysis|General linear model, controlling for baseline values.|The Mean Difference was calculated as MADRS unit scale for the CBT-AD Arm minus the MADRS unit scale for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of depression as assessed on the MADRS at acute outcome.||10.56|2.33|=.002
73836389|NCT00564070|147222009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||=|0.01|TWO_SIDED|95.0|0.16|1.32|||ANCOVA|using GLM|The Mean Difference was calculated as CGI unit scale for the Enhanced Treatment as Usual Arm minus the CGI unit scale for the CBT-AD Arm.|||1.32|.16|=.01
73836390|NCT00564070|147222010|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|22.3|STANDARD_ERROR_OF_MEAN|7.0|=|0.002|TWO_SIDED|95.0|8.6|36.1|||Mixed Models Analysis|||We hypothesized that differences in glucose monitoring adherence would continue to be superior in the CBT-AD condition compared to ETAU||36.1|8.6|=.002
73836391|NCT00564070|147222011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.3|STANDARD_ERROR_OF_MEAN|5.0|=|0.001|TWO_SIDED|95.0|6.5|26.1|||Mixed Models Analysis|||We hypothesized that the CBT-AD condition would maintain higher medication adherence over follow up compared to ETAU||26.1|6.5|=.001
73836392|NCT00564070|147222012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.1||0.16|TWO_SIDED|95.0|-1.2|7.2|||Mixed Models Analysis|||We hypothesized that the lower depression scores would remain in the CBT arm compared to ETAU over follow up.||7.2|-1.2|.16
73836393|NCT00564070|147222013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.29||0.1|TWO_SIDED|95.0|-0.1|1.1|||Mixed Models Analysis|||We hypothesized that depression scores would remain lower in the CBT-AD arm compared to the ETAU arm||1.1|-.1|.10
73836394|NCT00564070|147222014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.29||0.03|TWO_SIDED|95.0|0.6|1.2|||Mixed Models Analysis|||We hypothesized that glucose control (HbA1C) would remain superior in the CBT-AD arm compared to the ETAU arm over follow up.||1.2|.6|.03
73836395|NCT03142334|147222029|OTHER|HR and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.68||||0.001|TWO_SIDED|95.0|0.53|0.87|||Log Rank|One-sided p-value was based on log-rank test stratified by metastasis status, ECOG PS, US participant within M0 group by investigator.|Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status, ECOG PS, and US participant within M0 group by investigator was used to calculate HR and 95% CIs.|||0.87|0.53|0.0010
73836396|NCT05529173|147222049|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73836397|NCT00191152|147222081|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Log Rank|||||||0.145
73836398|NCT00191152|147222082|SUPERIORITY_OR_OTHER|||||||0.361||95.0|||||Log Rank|||||||0.361
73836399|NCT00191152|147222083|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Log Rank|||||||0.145
73836400|NCT00191152|147222084|SUPERIORITY_OR_OTHER|||||||0.385||95.0|||||Log Rank|||||||0.385
73836401|NCT00191152|147222085|SUPERIORITY_OR_OTHER|||||||0.377||95.0|||||Log Rank|||||||0.377
73836402|NCT00191152|147222086|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Log Rank|||||||0.446
73836403|NCT00191152|147222087|SUPERIORITY_OR_OTHER|||||||0.785||95.0|||||Log Rank|||||||0.785
73836404|NCT00191152|147222088|SUPERIORITY_OR_OTHER|||||||0.364||95.0|||||Fisher Exact|||||||0.364
73836405|NCT00191152|147222089|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Fisher Exact|||||||0.446
73836406|NCT00191152|147222090|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Mixed Models Analysis|||||||0.990
73836407|NCT00191152|147222091|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||Mixed Models Analysis|||||||0.117
73836408|NCT00191152|147222092|SUPERIORITY_OR_OTHER|||||||0.801||95.0|||||Mixed Models Analysis|||||||0.801
73836409|NCT00191152|147222093|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Mixed Models Analysis|||||||0.190
73836410|NCT00114777|147222094|SUPERIORITY_OR_OTHER||Treament Difference|1.1|||||TWO_SIDED|97.3|-7.2|9.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).|||9.4|-7.2|
73836411|NCT00114777|147222094|SUPERIORITY_OR_OTHER||Treatment difference|3.2|||||TWO_SIDED|97.3|-5.0|11.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).|||11.4|-5.0|
73836412|NCT00114777|147222095|SUPERIORITY_OR_OTHER||Percentage difference|-14.4||||0.0018|TWO_SIDED|97.3|-24.0|-4.7|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.|||-4.7|-24|0.0018
73836413|NCT00114777|147222095|SUPERIORITY_OR_OTHER||Percentage difference|-8.5||||0.0616|TWO_SIDED|97.3|-18.0|0.9|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.|||0.9|-18|0.0616
73836414|NCT02046200|147222152|SUPERIORITY_OR_OTHER|||||||0.0563|||||||ANOVA|||||||0.0563
73836415|NCT02046200|147222153|SUPERIORITY_OR_OTHER|||||||0.0342|||||||ANOVA|||||||0.0342
73836416|NCT02046200|147222154|SUPERIORITY_OR_OTHER|||||||0.1597|||||||ANOVA|||||||0.1597
73836417|NCT02046200|147222155|SUPERIORITY_OR_OTHER|||||||0.7617|||||||ANOVA|||||||0.7617
73836418|NCT02046200|147222156|SUPERIORITY_OR_OTHER|||||||0.93|||||||ANOVA|||||||0.93
73836419|NCT02046200|147222157|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||||||0.95
73836420|NCT02046200|147222158|SUPERIORITY_OR_OTHER|||||||0.43|||||||ANOVA|||||||0.43
73836421|NCT02046200|147222159|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||||||0.06
73836422|NCT02046200|147222160|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANOVA|||||||0.21
73836423|NCT02046200|147222161|SUPERIORITY_OR_OTHER|||||||0.09|||||||ANOVA|||||||0.09
73836424|NCT02046200|147222162|SUPERIORITY_OR_OTHER|||||||0.99|||||||ANOVA|||||||0.99
73836425|NCT00395512|147222218|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.78|-0.33||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||The primary efficacy variable was defined as change from Baseline in HbA1c level at Week 26. The null hypothesis was that the average change from Baseline in HbA1c at Week 26 for the A25 + P30 group would be equal to the average changes for the P30 alone and A25 alone groups; further, under the null hypothesis, the average change from Baseline in HbA1c at Week 26 for the A12.5 + P30 group was equal to the average change for the P30 alone group.||-0.33|-0.78|<0.001
73836426|NCT00395512|147222218|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||||-0.53|-0.98|<0.001
73836427|NCT00395512|147222218|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.63|-0.18||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||||-0.18|-0.63|<0.001
73836428|NCT00395512|147222219|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33||||0.003|TWO_SIDED|95.0|-0.55|-0.12|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.||-0.12|-0.55|0.003
73836429|NCT00395512|147222219|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-0.30|-0.74|<0.001
73836430|NCT00395512|147222219|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-0.94|-0.51|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-0.51|-0.94|<0.001
73836431|NCT00395512|147222220|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.2||||0.017|TWO_SIDED|95.0|-20.3|-2.0|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.||-2.0|-20.3|0.017
73836432|NCT00395512|147222220|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.9||||0.006|TWO_SIDED|95.0|-22.0|-3.8|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-3.8|-22.0|0.006
73836433|NCT00395512|147222220|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.5|||<|0.001|TWO_SIDED|95.0|-33.5|-15.4|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-15.4|-33.5|<0.001
73836434|NCT00682838|147222259|SUPERIORITY_OR_OTHER|||||||0.5|||||||t-test, 1 sided|||||||0.50
73836435|NCT03566550|147222270|OTHER|||||||0.04|||||||Log Rank|||||||0.04
73836436|NCT03566550|147222271|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
73971415|NCT05196919|147483489|SUPERIORITY||Mean Difference (Final Values)|-6.15|STANDARD_ERROR_OF_MEAN|4.676||0.1933|TWO_SIDED|95.0|-15.49|3.19|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||3.19|-15.49|0.1933
73836437|NCT03566550|147222272|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
73836438|NCT03566550|147222273|OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
73836439|NCT03566550|147222274|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
73836440|NCT02618187|147222278|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.766|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.766
73836441|NCT02618187|147222278|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.037|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.037
73836442|NCT02618187|147222278|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.313|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.313
73836443|NCT02618187|147222278|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.384|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.384
73836444|NCT02618187|147222278|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.237|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.237
73836445|NCT02618187|147222279|SUPERIORITY|Weekly SER-287, after Placebo Pre-Treat. tested against Daily placebo, after Placebo Pre-Treat., for superiority||||||0.257|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.257
73836446|NCT02618187|147222279|SUPERIORITY|Daily SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.001
73836447|NCT02618187|147222279|SUPERIORITY|Weekly SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.001
73836448|NCT02618187|147222279|SUPERIORITY|Weekly SER-287, After Vanco. Pre-Treat. tested against Weekly SER-287, After Placebo Pre-Treat., for superiority||||||0.009|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.009
73836449|NCT02618187|147222279|SUPERIORITY|Daily SER-287, After Vanco. Pre-Treat., tested against Weekly SER-287, After Vanco. Pre-Treat., for superiority||||||0.168|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.168
73836450|NCT02618187|147222280|SUPERIORITY||Rate difference (SER-287 - placebo)|13.3||||0.4923|TWO_SIDED|95.0|-3.87|30.54|||Fisher Exact|||||30.54|-3.87|0.4923
73836451|NCT02618187|147222280|SUPERIORITY||Rate difference (SER-287 - placebo)|40.0||||0.0237|TWO_SIDED|95.0|15.21|64.79|||Fisher Exact|||||64.79|15.21|0.0237
73836452|NCT02618187|147222280|SUPERIORITY||Rate difference (SER-287 - placebo)|17.6||||0.2579|TWO_SIDED|95.0|-0.47|35.77|||Fisher Exact|||||35.77|-0.47|0.2579
73836453|NCT02618187|147222281|SUPERIORITY||Rate difference (SER-287 - placebo)|24.2||||0.1973|TWO_SIDED|95.0|-5.04|53.53|||Fisher Exact|||||53.53|-5.04|0.1973
73836454|NCT02618187|147222281|SUPERIORITY||Rate difference (SER-287 - placebo)|30.9||||0.1783|TWO_SIDED|95.0|0.86|60.96|||Fisher Exact|||||60.96|0.86|0.1783
73836455|NCT02618187|147222281|SUPERIORITY||Rate difference (SER-287 - placebo)|14.4||||0.6195|TWO_SIDED|95.0|-11.93|40.81|||Fisher Exact|||||40.81|-11.93|0.6195
73836456|NCT04576949|147222283|SUPERIORITY||Odds Ratio (OR)|8.0|||<|0.0001|TWO_SIDED|95.0|3.94|16.25||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 3 to Week 6||16.25|3.94|< 0.0001
73836457|NCT04576949|147222283|SUPERIORITY||Marginal Difference in Proportions|0.21|||<|0.0001|TWO_SIDED|95.0|0.16|0.25||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.25|0.16|<0.0001
73836458|NCT04576949|147222284|SUPERIORITY||Odds Ratio (OR)|6.29|||<|0.0001|TWO_SIDED|95.0|3.69|11.57||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 9 to Week 12||11.57|3.69|< 0.0001
73836459|NCT04576949|147222284|SUPERIORITY||Marginal Difference in Proportions|0.26|||<|0.0001|TWO_SIDED|95.0|0.2|0.3||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.30|0.20|<0.0001
74020454|NCT00364182|147593277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.004|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.9|0.2|0.004
73836460|NCT04576949|147222285|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0016|TWO_SIDED|95.0|1.5|10.24||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations|||Abstinence from Week 6 to Week 24|Stratified by site|10.24|1.50|0.0016
73836461|NCT04576949|147222285|SUPERIORITY||Marginal Difference in Proportions|0.06||||0.0015|TWO_SIDED|95.0|0.03|0.09||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.09|0.03|0.0015
73836462|NCT04576949|147222286|SUPERIORITY||Odds Ratio (OR)|5.32|||<|0.0001|TWO_SIDED|95.0|2.81|11.09||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 12 to Week 24||11.09|2.81|< 0.0001
73836463|NCT04576949|147222286|SUPERIORITY||Marginal Difference in Proportions|0.16|||<|0.0001|TWO_SIDED|95.0|0.11|0.2||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.20|0.11|<.0001
73836464|NCT04576949|147222287|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3484|TWO_SIDED|95.0|0.75|2.33||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Relapse free from Week 6 to Week 24||2.33|0.75|0.3484
73836465|NCT03518203|147222326|EQUIVALENCE|A binomial test was used to test 6 month survival in study cohort against an 18% historical rate.|Proportion|0.714|||<|0.0001|TWO_SIDED|||||The a priori threshold was 0.05.|binomial test|||||||<0.0001
73836466|NCT02362412|147222336|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.5|||||TWO_SIDED|95.0|-3.4|2.3||p-value was not adjusted|||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||2.3|-3.4|
73836467|NCT02362412|147222337|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-1.7|1.9|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||1.9|-1.7|
73836468|NCT02362412|147222338|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.4|-0.3|
73836469|NCT02362412|147222339|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.4|-0.3|
73836470|NCT02362412|147222341|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.5|-0.5|
74020455|NCT00364182|147593277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.093|TWO_SIDED|95.0|-0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.8|-0.1|0.093
73836471|NCT02362412|147222342|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.5|-0.5|
73863131|NCT01345682|147272232|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.4|STANDARD_ERROR_OF_MEAN|2.01||0.03|TWO_SIDED|95.0|-8.31|-0.42||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score (PS) and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||-0.42|-8.31|0.0300
73836472|NCT05103332|147222359|SUPERIORITY||Difference in LS Mean|-12.1|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|95.0|-16.5|-7.6||MMRM: Fixed factors: treatment, visit, treatment-by-visit interaction, race (black/all other races); Covariates: Baseline (BA) 24-hour mean SBP using ABPM \& BA estimated glomerular filtration rate (eGFR). Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-7.6|-16.5|<0.0001
73836473|NCT05103332|147222360|SUPERIORITY||Difference in LS Mean|-9.7|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED|95.0|-12.9|-6.6||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-6.6|-12.9|<0.0001
73836474|NCT05103332|147222361|SUPERIORITY||Difference in LS Mean|-4.5|STANDARD_ERROR_OF_MEAN|1.89|=|0.0183|TWO_SIDED|95.0|-8.2|-0.8||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-0.8|-8.2|=0.0183
73836475|NCT05103332|147222362|SUPERIORITY||Difference in LS Mean|-18.5|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-22.8|-14.2||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-14.2|-22.8|<0.0001
73836476|NCT05103332|147222363|SUPERIORITY||Difference in LS Mean|-11.0|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-14.7|-7.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||-7.3|-14.7|<0.0001
73836477|NCT05103332|147222364|SUPERIORITY||Difference in LS Mean|-13.6|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED|95.0|-16.9|-10.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-10.3|-16.9|<0.0001
73836478|NCT05103332|147222365|SUPERIORITY||Odds Ratio (OR)|12.39|||<|0.0001|TWO_SIDED|95.0|4.61|33.29||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||33.29|4.61|<0.0001
73897622|NCT01106092|147328312|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.72|-4.78|
73836479|NCT05103332|147222376|SUPERIORITY||Difference in LS Mean|-10.2|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-13.4|-6.9||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-6.9|-13.4|<0.0001
73836480|NCT05103332|147222377|SUPERIORITY||Difference in LS Mean|-7.9|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-10.6|-5.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||-5.3|-10.6|<0.0001
73836481|NCT05103332|147222378|SUPERIORITY||Difference in LS Mean|-8.6|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-10.9|-6.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-6.3|-10.9|<0.0001
73836482|NCT05103332|147222379|SUPERIORITY||Odds Ratio (OR)|5.08|||<|0.0001|TWO_SIDED|95.0|2.43|10.61||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||10.61|2.43|<0.0001
73836483|NCT05103332|147222390|SUPERIORITY||Difference in LS Mean|-6.7|STANDARD_ERROR_OF_MEAN|1.76|=|0.0002|TWO_SIDED|95.0|-10.2|-3.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-3.3|-10.2|=0.0002
73836484|NCT05103332|147222391|SUPERIORITY||Difference in LS Mean|-1.8|STANDARD_ERROR_OF_MEAN|1.42|=|0.2103|TWO_SIDED|95.0|-4.6|1.0||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||1.0|-4.6|=0.2103
73836485|NCT05103332|147222392|SUPERIORITY||Difference in LS Mean|-4.5|STANDARD_ERROR_OF_MEAN|1.14|<|0.0001|TWO_SIDED|95.0|-6.8|-2.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-2.3|-6.8|<0.0001
73836486|NCT05103332|147222393|SUPERIORITY||Odds Ratio (OR)|1.67|||=|0.123|TWO_SIDED|95.0|0.87|3.23||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||3.23|0.87|=0.1230
73836487|NCT04906421|147222410|SUPERIORITY|||||||0.0018||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||ITT Population analysis||||0.0018
73836488|NCT04906421|147222410|SUPERIORITY|||||||0.0035||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||ITT Population Analysis||||0.0035
73836489|NCT04906421|147222410|SUPERIORITY|||||||0.0001||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|t-test, 1 sided|One-sided||mITT Population Analysis||||0.0001
73836490|NCT04906421|147222410|SUPERIORITY|||||||0.0003||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0003
73836491|NCT04906421|147222411|SUPERIORITY|||||||0.0087||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||ITT Population Analysis||||0.0087
73836492|NCT04906421|147222411|SUPERIORITY|||||||0.0173||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||ITT Population Analysis||||0.0173
73836493|NCT04906421|147222411|SUPERIORITY|||||||0.0022||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||mITT Population Analysis||||0.0022
73836494|NCT04906421|147222411|SUPERIORITY|||||||0.0044||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0044
73836495|NCT04906421|147222412|SUPERIORITY|||||||0.0102|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0102
73836496|NCT04906421|147222412|SUPERIORITY|||||||0.59|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||Subgroup Fibrosis Stage F2 at Baseline Population Analysis||||0.59
73836497|NCT04906421|147222412|SUPERIORITY|||||||0.0032|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-Sided||Subgroup Fibrosis Stage F3 at Baseline Population Analysis||||0.0032
73897623|NCT01106092|147328312|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.72|-4.78|
73836498|NCT04906421|147222412|SUPERIORITY|||||||0.0764|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||Subgroup Type 2 Diabetes Mellitus at Baseline Population Analysis||||0.0764
73836499|NCT04906421|147222413|SUPERIORITY|||||||0.0043||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0043
73836500|NCT04906421|147222414|SUPERIORITY|||||||0.0018||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0018
73836501|NCT04906421|147222415|SUPERIORITY||||||<|0.0001||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||<0.0001
73836502|NCT01125748|147222416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3|||||TWO_SIDED|95.0|5.0|33.6||||||||33.6|5.0|
73836503|NCT01028391|147222418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|4.0||||95.0|-0.76|-0.26|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) HbA1c.|||-0.26|-0.76|
73836504|NCT01028391|147222419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.5|STANDARD_ERROR_OF_MEAN|4.0||||95.0|-16.3|-0.7|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) FPG.|||-0.7|-16.3|
73836505|NCT01227395|147222422|SUPERIORITY_OR_OTHER||||||=|0.696|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.696
73836506|NCT01227395|147222423|SUPERIORITY_OR_OTHER||||||=|0.334|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.334
73836507|NCT01227395|147222424|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was concomitant drugs. The null hypothesis is there is no difference between with and without concomitant drugs  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
73836508|NCT01227395|147222425|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
73836509|NCT01227395|147222426|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.015
73836510|NCT01227395|147222427|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
73836511|NCT01227395|147222428|SUPERIORITY_OR_OTHER||||||=|0.29|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.290
73836512|NCT01227395|147222429|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.003
73836513|NCT01227395|147222430|SUPERIORITY_OR_OTHER||||||=|0.707|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.707
73836514|NCT01398475|147222433|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.02|||||TWO_SIDED|90.0|0.951|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.10|0.951|
73836515|NCT01398475|147222433|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|1.02|||||TWO_SIDED|90.0|0.947|1.09|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.09|0.947|
73836516|NCT01398475|147222433|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.888|||||TWO_SIDED|90.0|0.827|0.953|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||0.953|0.827|
73836517|NCT01398475|147222434|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|0.979|||||TWO_SIDED|90.0|0.868|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.10|0.868|
73836518|NCT01398475|147222434|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.962|||||TWO_SIDED|90.0|0.852|1.08|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.08|0.852|
73836519|NCT01398475|147222434|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.82|||||TWO_SIDED|90.0|0.727|0.925|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||0.925|0.727|
73836520|NCT01398475|147222435|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.719|TWO_SIDED|90.0|-0.25|0.5|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF1 fasted minus RF fasted.|||0.500|-0.250|0.719
73836521|NCT01398475|147222435|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.96|TWO_SIDED|90.0|-0.25|0.75|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fasted minus RF fasted.|||0.750|-0.250|0.960
73836522|NCT01398475|147222435|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.006|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fed minus TF2 fasted.|||2.00|0|0.006
73836523|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.77|||||TWO_SIDED|95.0|1.3|2.4||||||1 min post bolus (Bolus time: 3 hours)||2.40|1.30|
73836524|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.91|||||TWO_SIDED|95.0|1.42|2.59||||||1 min post bolus (Bolus time: 3 hours)||2.59|1.42|
73836525|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.84|||||TWO_SIDED|95.0|1.37|2.49||||||1 min post bolus (Bolus time: 3 hours)||2.49|1.37|
73836526|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.42|||||TWO_SIDED|95.0|1.05|1.92||||||1 min post bolus (Bolus time: 3 hours)||1.92|1.05|
73836527|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.08|||||TWO_SIDED|95.0|0.8|1.46||||||1 min post bolus (Bolus time: 3 hours)||1.46|0.80|
73836528|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.77|1.41||||||1 min post bolus (Bolus time: 3 hours)||1.41|0.77|
73930694|NCT03238911|147391292|SUPERIORITY||Mean Difference (Final Values)|22.87|||<|0.0001|TWO_SIDED|95.0|14.79|30.95|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||30.95|14.79|<0.0001
73836529|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|0.8|||||TWO_SIDED|95.0|0.59|1.08||||||1 min post bolus (Bolus time: 3 hours)||1.08|0.59|
73836530|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|0.96|||||TWO_SIDED|95.0|0.72|1.3||||||1 min post bolus (Bolus time: 3 hours)||1.30|0.72|
73836531|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||1 min post bolus (Bolus time: 3 hours)||1.00|0.55|
73836532|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|0.77|||||TWO_SIDED|95.0|0.57|1.04||||||1 min post bolus (Bolus time: 3 hours)||1.04|0.57|
73836533|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.49|||||TWO_SIDED|95.0|1.09|2.02||||||1 min post bolus (Bolus time: 6 hours)||2.02|1.09|
73836534|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.68|||||TWO_SIDED|95.0|1.25|2.28||||||1 min post bolus (Bolus time: 6 hours)||2.28|1.25|
73836535|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.84|||||TWO_SIDED|95.0|1.36|2.48||||||1 min post bolus (Bolus time: 6 hours)||2.48|1.36|
73836536|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.16|||||TWO_SIDED|95.0|0.85|1.56||||||1 min post bolus (Bolus time: 6 hours)||1.56|0.85|
73836537|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.13|||||TWO_SIDED|95.0|0.83|1.54||||||1 min post bolus (Bolus time: 6 hours)||1.54|0.83|
73836538|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.24|||||TWO_SIDED|95.0|0.91|1.68||||||1 min post bolus (Bolus time: 6 hours)||1.68|0.91|
73836539|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|0.78|||||TWO_SIDED|95.0|0.57|1.05||||||1 min post bolus (Bolus time: 6 hours)||1.05|0.57|
73836540|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.09|||||TWO_SIDED|95.0|0.81|1.47||||||1 min post bolus (Bolus time: 6 hours)||1.47|0.81|
73836541|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|0.69|||||TWO_SIDED|95.0|0.51|0.93||||||1 min post bolus (Bolus time: 6 hours)||0.93|0.51|
73836542|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|0.63|||||TWO_SIDED|95.0|0.47|0.85||||||1 min post bolus (Bolus time: 6 hours)||0.85|0.47|
73836543|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.49|||||TWO_SIDED|95.0|1.1|2.03||||||1 min post bolus (Bolus time: 9 hours)||2.03|1.10|
73836544|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.96|||||TWO_SIDED|95.0|1.45|2.65||||||1 min post bolus (Bolus time: 9 hours)||2.65|1.45|
73836545|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|2.03|||||TWO_SIDED|95.0|1.5|2.74||||||1 min post bolus (Bolus time: 9 hours)||2.74|1.50|
73836546|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.25|||||TWO_SIDED|95.0|0.93|1.69||||||1 min post bolus (Bolus time: 9 hours)||1.69|0.93|
73836547|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.31|||||TWO_SIDED|95.0|0.97|1.78||||||1 min post bolus (Bolus time: 9 hours)||1.78|0.97|
73836548|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.36|||||TWO_SIDED|95.0|1.01|1.84||||||1 min post bolus (Bolus time: 9 hours)||1.84|1.01|
73836549|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|0.84|||||TWO_SIDED|95.0|0.62|1.14||||||1 min post bolus (Bolus time: 9 hours)||1.14|0.62|
73836550|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.77|1.4||||||1 min post bolus (Bolus time: 9 hours)||1.40|0.77|
73836551|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|0.64|||||TWO_SIDED|95.0|0.47|0.86||||||1 min post bolus (Bolus time: 9 hours)||0.86|0.47|
73836552|NCT05067270|147222461|OTHER||Geometric Least Squares Mean Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.83||||||1 min post bolus (Bolus time: 9 hours)||0.83|0.46|
73836553|NCT05894564|147222467|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.88|1.1|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.10|0.88|
73836554|NCT05894564|147222468|SUPERIORITY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.65|||||Low event rate precluded covariate adjustment.|No hypothesis test or decision rule was evaluated.||5.65|0.05|
73836555|NCT05894564|147222471|SUPERIORITY|Posterior probability of efficacy (P(HR\<1))|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.31|1.28|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.28|0.31|
74020456|NCT00364182|147593278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.1|-0.4|0.000
74020457|NCT00364182|147593278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0|TWO_SIDED|95.0|-0.5|-0.2|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.2|-0.5|0.0000
73836556|NCT05894564|147222472|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.56|1.87|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.87|0.56|
73836557|NCT05894564|147222473|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.25|1.16|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.16|0.25|
74020458|NCT00364182|147593278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.002|TWO_SIDED|95.0|-0.5|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.1|-0.5|0.002
73836558|NCT05894564|147222474|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.33|1.74|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.74|0.33|
73836559|NCT05894564|147222475|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.71|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.21|0.71|
73836560|NCT05894564|147222475|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.67|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.19|0.67|
73836561|NCT05894564|147222475|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.61|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.19|0.61|
73836562|NCT05894564|147222475|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.61|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.28|0.61|
73836563|NCT05894564|147222475|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.7|1.49|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.49|0.70|
73836564|NCT05894564|147222476|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.27|0.80|
73836565|NCT05894564|147222476|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.77|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.26|0.77|
74020459|NCT00364182|147593278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.031|TWO_SIDED|95.0|-0.5|0.0|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.0|-0.5|0.031
74020460|NCT00364182|147593282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.544|TWO_SIDED|95.0|-9.2|4.9|||ANOVA|||||4.9|-9.2|0.544
74020461|NCT00364182|147593282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.592|TWO_SIDED|95.0|-7.5|4.3|||ANOVA|||||4.3|-7.5|0.592
73836566|NCT05894564|147222476|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.67|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.67|
73836567|NCT05894564|147222476|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.77|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.36|0.77|
73836568|NCT05894564|147222476|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.76|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.33|0.76|
73836569|NCT05894564|147222477|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.65|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.09|0.65|
73836570|NCT05894564|147222477|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.32|0.74|
73836571|NCT05894564|147222477|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.21|0.64|
73836572|NCT05894564|147222477|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.87|1.73|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.73|0.87|
73836573|NCT05894564|147222477|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.85|1.64|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.64|0.85|
73836574|NCT05894564|147222478|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.33|0.74|
73836575|NCT05894564|147222478|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.59|1.1|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.10|0.59|
73836576|NCT05894564|147222478|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.59|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.12|0.59|
73836577|NCT05894564|147222478|OTHER||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.83|1.62|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.62|0.83|
73836578|NCT05894564|147222478|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.7|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.34|0.70|
73836579|NCT05894564|147222479|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.79|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.34|0.79|
73971416|NCT05196919|147483489|SUPERIORITY||Mean Difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|4.434||0.2511|TWO_SIDED|95.0|-3.73|14.0|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||14.00|-3.73|0.2511
73836580|NCT05894564|147222479|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.32|0.74|
73836581|NCT05894564|147222479|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.64|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.20|0.64|
73836582|NCT05894564|147222479|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.7|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.34|0.70|
73836583|NCT05894564|147222479|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.64|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.25|0.64|
73836584|NCT05894564|147222480|OTHER||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.61|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.01|0.61|
73836585|NCT05894564|147222480|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.64|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.11|0.64|
74020462|NCT00364182|147593282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6||||0.131|TWO_SIDED|95.0|-1.1|8.4|||ANOVA|||||8.4|-1.1|0.131
73836586|NCT05894564|147222480|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.63|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.12|0.63|
73836587|NCT05894564|147222480|OTHER||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.6|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.12|0.60|
73836588|NCT05894564|147222480|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.67|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.24|0.67|
73836589|NCT05894564|147222481|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.81|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.27|0.81|
73836590|NCT05894564|147222481|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.18|0.76|
73836591|NCT05894564|147222481|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.72|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.72|
73836592|NCT05894564|147222481|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.79|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.26|0.79|
73836593|NCT05894564|147222481|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.64|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.01|0.64|
73836594|NCT05894564|147222482|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|-0.17|||||TWO_SIDED|95.0|-0.56|0.26|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.26|-0.56|
73836595|NCT05894564|147222483|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimated means|0.21|||||TWO_SIDED|95.0|-0.29|0.68|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.68|-0.29|
73836596|NCT03882801|147222484|SUPERIORITY||Least Square Geometric Means Ratio|0.92|||||TWO_SIDED|90.0|0.73|1.17|||||Back transformed least squares mean and confidence interval from linear mixed effects model performed on natural log-transformed values.|||1.17|0.73|
73836597|NCT03548415|147222506|SUPERIORITY|||||||0.306||||||The p-value was analyzed using the nonparametric test, Van Elteren test with IGF-1 level as stratification factor.|Van Elteren test|||||||0.306
73836598|NCT00604383|147222552|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.034
73836599|NCT01122680|147222558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.039||0.0043||95.0|0.036|0.19||First step of closed testing procedure, where the active treatments are compared to placebo. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Placebo||0.190|0.036|0.0043
74020463|NCT01261559|147593304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|10.0||0.003|TWO_SIDED|95.0|4.0|25.0|||Regression, Linear|A multivariate linear regression model was fitted for the main outcome of percent relative dose, with age, BMI, and bra cup size as covariates.||Powered to detect difference of 10% at 80% power if 66 or more subjects enrolled.||25|4|0.003
74020464|NCT02921425|147593313|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||.003
73836600|NCT01122680|147222558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.039||0.1484||95.0|-0.021|0.135||Second step of closed testing procedure. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R2.5 minus Placebo||0.135|-0.021|0.1484
73836601|NCT01122680|147222558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.036||0.0664||95.0|-0.005|0.138||This test is considered as descriptive.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo||0.138|-0.005|0.0664
73836602|NCT01122680|147222558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.039||||95.0|-0.031|0.124|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Tio R1.25||0.124|-0.031|
73836603|NCT01122680|147222558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.036||||95.0|-0.014|0.126|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Tio R2.5||0.126|-0.014|
73836604|NCT01122680|147222558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.088|0.069|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R2.5 minus Tio R1.25||0.069|-0.088|
73836605|NCT03892915|147222589|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.73|1.93||||||||1.93|0.73|
73836606|NCT03892915|147222590|SUPERIORITY||beta coefficient|5.33|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|||||||||||||
74020465|NCT02921425|147593315|OTHER|||||||0.007|||||||t-test, 2 sided|||||||.007
73836607|NCT03892915|147222592|SUPERIORITY||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.53|6.5||||||||6.50|0.53|
73836608|NCT03892915|147222593|SUPERIORITY||Odds Ratio (OR)|2.73|||||TWO_SIDED|95.0|0.45|16.64||||||||16.64|0.45|
73836609|NCT03892915|147222594|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.05|0.83||||||||0.83|0.05|
73836610|NCT01691482|147222632|SUPERIORITY_OR_OTHER||Adjusted Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.067|0.049|
73836611|NCT01691482|147222632|SUPERIORITY_OR_OTHER||Adjusted Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.080|0.062|
73836612|NCT01691482|147222632|SUPERIORITY_OR_OTHER||Adjusted Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.062|0.044|
73836613|NCT01691482|147222632|SUPERIORITY_OR_OTHER||Slope|0.062|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.071|0.053|
73836614|NCT01691482|147222636|SUPERIORITY_OR_OTHER||Adjusted Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.067|0.049|
73836615|NCT01691482|147222636|SUPERIORITY_OR_OTHER||Adjusted Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.080|0.062|
73836616|NCT01691482|147222636|SUPERIORITY_OR_OTHER||Adjusted Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.062|0.044|
73836617|NCT01691482|147222636|SUPERIORITY_OR_OTHER||Adjusted Mean|0.062||||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.071|0.053|
73836618|NCT01691482|147222637|SUPERIORITY_OR_OTHER||Adjusted Mean|0.067|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.058|0.076|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.076|0.058|
73836619|NCT01691482|147222637|SUPERIORITY_OR_OTHER||Adjusted Mean|0.07|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.061|0.079|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.079|0.061|
73836620|NCT01691482|147222637|SUPERIORITY_OR_OTHER||Adjusted Mean|0.069|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.06|0.078|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.078|0.060|
73836621|NCT01691482|147222637|SUPERIORITY_OR_OTHER||Adjusted Mean|0.064|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.055|0.073|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.073|0.055|
73836622|NCT01691482|147222638|SUPERIORITY_OR_OTHER||Adjusted Mean|0.228|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.2|0.255|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.255|0.200|
73836623|NCT01691482|147222638|SUPERIORITY_OR_OTHER||Adjusted Mean|0.231|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.203|0.258|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.258|0.203|
73836624|NCT01691482|147222638|SUPERIORITY_OR_OTHER||Adjusted Mean|0.232|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.204|0.259|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.259|0.204|
73836625|NCT01691482|147222638|SUPERIORITY_OR_OTHER||Adjusted Mean|0.217|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.19|0.245|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.245|0.190|
73836626|NCT00407030|147222639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-12.0|-5.9||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||-5.9|-12.0|<0.001
73971417|NCT05194956|147483622|SUPERIORITY||Mean Difference (Net)|8.5||||0.0006|TWO_SIDED|95.0|3.75|13.15|||Two-period two-treatment crossover ANOVA|P-values are calculated taking sequence and period effects into account.|This estimation value assumes period and sequence effects are equal between the treatments.|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)||13.15|3.75|0.0006
73836627|NCT00407030|147222645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||<|0.001|TWO_SIDED|95.0|-10.4|-4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||-4.6|-10.4|<0.001
73836628|NCT00407030|147222646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.447|TWO_SIDED|95.0|-2.1|4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||4.6|-2.1|0.447
73836629|NCT03193307|147222647|OTHER||Geometric Mean (T1/R1) ratio (%)|153.2|||||TWO_SIDED|90.0|134.34|174.7|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) =21.4."|||174.70|134.34|
73836630|NCT03193307|147222648|OTHER||Geometric Mean (T1/R1) ratio (%)|115.91|||||TWO_SIDED|90.0|104.559|128.502|||||"Analysis of variance (ANOVA) including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 16.7."|||128.502|104.559|
73836631|NCT03193307|147222649|OTHER||Geometric Mean (T2/R2) ratio (%)|104.82|||||TWO_SIDED|90.0|102.092|107.613|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) =4.3."|||107.613|102.092|
73836632|NCT03193307|147222650|OTHER||Geometric Mean (T2/R2) ratio (%)|102.77|||||TWO_SIDED|90.0|100.66|104.92|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 3.3."|||104.92|100.66|
73836633|NCT03193307|147222651|OTHER||Geometric Mean (T2/R2) ratio (%)|114.12|||||TWO_SIDED|90.0|109.266|119.183|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\])=7.0."|||119.183|109.266|
73836634|NCT03193307|147222652|OTHER||Geometric Mean (T2/R2) ratio (%)|110.7|||||TWO_SIDED|90.0|105.8|115.83|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 7.3."|||115.83|105.80|
73836635|NCT03193307|147222653|OTHER||Geometric Mean (T1/R1) ratio (%)|154.15|||||TWO_SIDED|90.0|133.81|177.58|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 22.4."|||177.58|133.81|
73836636|NCT00754559|147222663|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Exact Binomial Test|||Null hypothesis: Proportion of participants reaching LDAS (≤ 3.2) at Week 24 equals (=) expected proportion of 42%.||||<0.001
73836637|NCT00676689|147222717|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|0.971|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.889|0.993||||||||0.993|0.889|
73836638|NCT00676689|147222718|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|0.941|STANDARD_ERROR_OF_MEAN|0.028|||TWO_SIDED|95.0|0.851|0.978||||||Freedom from Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) at 6 months in the valve implant population.||0.978|0.851|
73836639|NCT00676689|147222719|SUPERIORITY_OR_OTHER_LEGACY||Percentage|87.9|||||TWO_SIDED|||||||||Overall functional improvement at 6 months for patients in the valve implant population with baseline and 6 month data.||||
73836640|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.81|||||TWO_SIDED|95.0|0.61|1.07||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.07|0.61|
73971418|NCT05194956|147483622|SUPERIORITY|Sequence effects||||||0.1984|||||||ANOVA|||||||0.1984
73971419|NCT05194956|147483622|SUPERIORITY|Period effects||||||0.7494|||||||ANOVA|||||||0.7494
73836641|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC Ratio|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.52|0.87|
73971420|NCT05194956|147483622|SUPERIORITY|Mixed effects modelling|Mean Difference (Net)|-13.31||||0.001|TWO_SIDED|95.0|-21.29|-5.33|||Mixed Models Analysis|||||-5.33|-21.29|0.001
73836642|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC Ratio|1.42|||||TWO_SIDED|95.0|1.03|1.96||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.96|1.03|
73836643|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.62|||||TWO_SIDED|95.0|0.46|0.84||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.84|0.46|
73836644|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.89|||||TWO_SIDED|95.0|0.66|1.2||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.66|
73836645|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.44|||||TWO_SIDED|95.0|1.02|2.04||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.04|1.02|
73836646|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.82|1.32||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.32|0.82|
73971421|NCT05194956|147483623|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-3.4||||0.123|TWO_SIDED|95.0|-7.71|0.91||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||0.91|-7.71|0.1230
73836647|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.86|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.86|
73836648|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.05|||||TWO_SIDED|95.0|0.79|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.79|
73836649|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.77|1.34||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.34|0.77|
73836650|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.79|
73836651|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.74|1.4||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.40|0.74|
73836652|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.57|0.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.97|0.57|
73836653|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.85|||||TWO_SIDED|95.0|0.65|1.11||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.11|0.65|
73836654|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMCratio|1.14|||||TWO_SIDED|95.0|0.84|1.56||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.56|0.84|
73836655|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.37|||||TWO_SIDED|95.0|0.97|1.94||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.94|0.97|
73836656|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.1|||||TWO_SIDED|95.0|0.78|1.55||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.55|0.78|
73836657|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.54|1.19||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.19|0.54|
73836658|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.61|1.05||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.05|0.61|
73836659|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.95|||||TWO_SIDED|95.0|0.73|1.25||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.25|0.73|
73836660|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.19|||||TWO_SIDED|95.0|0.87|1.64||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.64|0.87|
73836661|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|3.62|||||TWO_SIDED|95.0|2.76|4.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.74|2.76|
73836662|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.4|0.68||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.68|0.40|
73836663|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.14|||||TWO_SIDED|95.0|0.1|0.2||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.20|0.10|
73836664|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.13|||||TWO_SIDED|95.0|0.8|1.59||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.59|0.80|
73836665|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.87|||||TWO_SIDED|95.0|0.62|1.23||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.62|
73836666|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.52|1.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.15|0.52|
73836667|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|3.49|||||TWO_SIDED|95.0|2.68|4.54||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.54|2.68|
73836668|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.4|0.68||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.68|0.40|
73836669|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.15|||||TWO_SIDED|95.0|0.11|0.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.20|0.11|
73836670|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.61|||||TWO_SIDED|95.0|1.15|2.23||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.23|1.15|
73836671|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.24|||||TWO_SIDED|95.0|0.89|1.72||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.72|0.89|
73836672|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.53|1.13||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.53|
73836673|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.63|||||TWO_SIDED|95.0|1.28|2.08||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.08|1.28|
73836674|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.03|||||TWO_SIDED|95.0|0.81|1.3||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.81|
73836675|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.63|||||TWO_SIDED|95.0|0.47|0.83||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.83|0.47|
73836676|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.99|||||TWO_SIDED|95.0|1.51|2.63||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.63|1.51|
73836677|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.79|
73836678|NCT01026038|147222730|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.38|0.72||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.72|0.38|
73836679|NCT01026038|147222731|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
73836680|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.429||95.0|||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.429
73836681|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.314
73836682|NCT01026038|147222731|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
73836683|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.552||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.552
73836684|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.499||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.499
73836685|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.376||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.376
73836686|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.633||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.633
73836687|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.658||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.658
73836688|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.544||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.544
73836689|NCT01026038|147222731|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
73836690|NCT01026038|147222731|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
73836691|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.859||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.859
73836692|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.197||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.197
73836693|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.198||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.198
73836694|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.443||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.443
73836695|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.261
73836696|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.687
73836697|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.671
73836698|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.253||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.253
73836699|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.074
73836700|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.323
73836701|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.489
73836702|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.607||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.607
73836703|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.549
73836704|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.864||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.864
73836705|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.859||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.859
73836706|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.836||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.836
73836707|NCT01026038|147222731|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
73836708|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.297||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.297
73836709|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.145
73836710|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.517||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.517
73836711|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.323
73836712|NCT01026038|147222731|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.489
73836713|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC||||0.075
73971422|NCT05194956|147483623|SUPERIORITY|Sequence effects||||||0.8423|||||||ANOVA|||||||0.8423
73836714|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC||||0.345
73836715|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.628||95.0|||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC||||0.628
73836716|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.592||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.592
73836717|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.608
73836718|NCT01026038|147222732|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
73836719|NCT01026038|147222732|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
73836720|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||Fisher Exact|||Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.333
73836721|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.215
73836722|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.714
73836723|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.397||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.397
73836724|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.215
73836725|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.714
73836726|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.397||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.397
73836727|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.161
73836728|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.226
73836729|NCT01026038|147222732|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
73836730|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.161
73836731|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.226
73836732|NCT01026038|147222732|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
73836733|NCT01026038|147222732|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
73836734|NCT01026038|147222732|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
73836735|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.237
73836736|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.045
73836737|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.285
73836738|NCT01026038|147222732|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
73836739|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.174
73971423|NCT05194956|147483623|SUPERIORITY|Period effects||||||0.9544|||||||ANOVA|||||||0.9544
74020466|NCT02921425|147593316|OTHER|||||||0.026|||||||t-test, 2 sided|||||||.026
73836740|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.125
73836741|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.058
73836742|NCT01026038|147222732|SUPERIORITY_OR_OTHER|||||||0.092||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.092
73836743|NCT01026038|147222732|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
73836744|NCT01026038|147222732|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
73836745|NCT01026038|147222732|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
73836746|NCT01026038|147222732|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
73836747|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.56|1.0||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.00|0.56|
73836748|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.73|1.28||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.28|0.73|
73836749|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC Ratio|1.29|||||TWO_SIDED|95.0|0.92|1.79||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.79|0.92|
73836750|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.7|||||TWO_SIDED|95.0|0.49|1.0||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.00|0.49|
73836751|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.89|||||TWO_SIDED|95.0|0.62|1.27||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.27|0.62|
73836752|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.27|||||TWO_SIDED|95.0|0.84|1.94||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.94|0.84|
73836753|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.78|||||TWO_SIDED|95.0|0.58|1.03||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.03|0.58|
73836754|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.01|||||TWO_SIDED|95.0|0.76|1.33||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.33|0.76|
73836755|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.29|||||TWO_SIDED|95.0|0.93|1.8||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.80|0.93|
73836756|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.69|1.58||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.58|0.69|
73836757|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.3|||||TWO_SIDED|95.0|0.86|1.97||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.97|0.86|
73836758|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.25|||||TWO_SIDED|95.0|0.77|2.03||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.03|0.77|
73836759|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.58|||||TWO_SIDED|95.0|0.42|0.78||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.78|0.42|
73836760|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.67|1.23||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.67|
73836761|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.58|||||TWO_SIDED|95.0|1.11|2.25||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.25|1.11|
73836762|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.05|||||TWO_SIDED|95.0|0.66|1.68||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.68|0.66|
73836763|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.54|||||TWO_SIDED|95.0|0.97|2.44||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.44|0.97|
73836764|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.46|||||TWO_SIDED|95.0|0.85|2.51||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.51|0.85|
73836765|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.56|1.15||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.56|
73836766|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.06|||||TWO_SIDED|95.0|0.74|1.52||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.52|0.74|
73836767|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.32|||||TWO_SIDED|95.0|0.87|2.01||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.01|0.87|
73836768|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|2.59|||||TWO_SIDED|95.0|1.8|3.73||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||3.73|1.80|
73836769|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.26|||||TWO_SIDED|95.0|0.88|1.79||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.79|0.88|
73836770|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.49|||||TWO_SIDED|95.0|0.32|0.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.74|0.32|
73836771|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.06|||||TWO_SIDED|95.0|0.61|1.87||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.87|0.61|
73970921|NCT04103580|147481871|SUPERIORITY||Slope|0.006|STANDARD_ERROR_OF_MEAN|0.004||0.15|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 1.||||0.150
74020467|NCT02921425|147593318|OTHER|||||||0.003||||||systolic blood pressure|t-test, 2 sided|||||||.003
74020468|NCT02921425|147593318|OTHER|||||||0.001|||||||t-test, 2 sided|||diastolic blood pressure||||.001
73836772|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.19|||||TWO_SIDED|95.0|0.68|2.09||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.09|0.68|
73836773|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.12|||||TWO_SIDED|95.0|0.59|2.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.15|0.59|
73836774|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.52|0.87|
73836775|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.69|1.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.69|
73836776|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.79|||||TWO_SIDED|95.0|0.57|1.1||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.10|0.57|
73836777|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|2.14|||||TWO_SIDED|95.0|1.52|3.02||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||3.02|1.52|
73836778|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.64|||||TWO_SIDED|95.0|1.16|2.3||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.30|1.16|
73836779|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.76|||||TWO_SIDED|95.0|0.51|1.14||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.14|0.51|
73836780|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|3.11|||||TWO_SIDED|95.0|2.23|4.33||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.33|2.23|
73836781|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.84|||||TWO_SIDED|95.0|0.61|1.17||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.17|0.61|
73836782|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.27|||||TWO_SIDED|95.0|0.19|0.4||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.40|0.19|
73836783|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratrio|1.82|||||TWO_SIDED|95.0|1.25|2.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.66|1.25|
73836784|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|1.33|||||TWO_SIDED|95.0|0.91|1.94||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.94|0.91|
73836785|NCT01026038|147222733|SUPERIORITY_OR_OTHER||GMC ratio|0.73|||||TWO_SIDED|95.0|0.47|1.13||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.47|
73930695|NCT03238911|147391292|SUPERIORITY||Mean Difference (Final Values)|10.6||||0.0043|TWO_SIDED|95.0|3.39|17.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||17.82|3.39|0.0043
74020469|NCT02921425|147593320|OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||.019
74080979|NCT02997176|147713965|OTHER|Bioequivalence|Percent Ratio of Geometric Means|109.76|||||TWO_SIDED|90.0|70.93|169.84||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||169.84|70.93|
73836786|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.63|||||TWO_SIDED|95.0|0.23|1.76||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.76|0.23|
73836787|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.3|1.99||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.99|0.30|
73836788|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC Ratio|1.21|||||TWO_SIDED|95.0|0.38|3.86||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.86|0.38|
73836789|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.93|||||TWO_SIDED|95.0|0.43|1.99||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.99|0.43|
73836790|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.54|2.22||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.22|0.54|
73836791|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.18|||||TWO_SIDED|95.0|0.5|2.79||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.79|0.50|
74080980|NCT02997176|147713965|OTHER|Bioequivalence|Percent Ratio of Geometric Means|131.67|||||TWO_SIDED|90.0|77.14|224.74||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||224.74|77.14|
73897624|NCT01106092|147328312|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||6.94|-3.53|
73897625|NCT01106092|147328312|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||6.94|-3.53|
73897626|NCT01106092|147328312|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||4.72|-4.78|
73897627|NCT01473368|147328337|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||0.026
73897628|NCT01473368|147328341|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73897629|NCT04839562|147328344|SUPERIORITY||Mean Difference (Final Values)|-4.3|||=|0.0106|TWO_SIDED|95.0|-7.7|-1.0|||t-test, 2 sided|||||-1|-7.7|=.0106
73897630|NCT04839562|147328345|SUPERIORITY||||||=|0.002|||||||Fisher Exact|||||||=.002
73897631|NCT04839562|147328346|SUPERIORITY||||||=|0.0173|||||||Fisher Exact|||||||=.0173
73897632|NCT04839562|147328347|SUPERIORITY||||||=|0.1144|||||||Fisher Exact|||||||=.1144
73897633|NCT04839562|147328348|SUPERIORITY||||||=|0.0348|||||||Fisher Exact|||||||=.0348
73897634|NCT04839562|147328349|SUPERIORITY||||||=|1|||||||Fisher Exact|||||||=1
73897635|NCT04839562|147328350|SUPERIORITY||||||=|0.0173|||||||Fisher Exact|||||||=.0173
73897636|NCT04839562|147328351|SUPERIORITY||||||=|0.1864|||||||Fisher Exact|||||||=.1864
73897637|NCT04839562|147328352|SUPERIORITY||||||=|0.4173|||||||Fisher Exact|||||||=.4173
73897638|NCT04839562|147328353|SUPERIORITY||||||=|0.0343|||||||Fisher Exact|||||||=.0343
73897639|NCT04839562|147328354|SUPERIORITY||||||=|0.0636|||||||Fisher Exact|||||||=.0636
73897640|NCT04839562|147328355|SUPERIORITY||||||=|0.065|||||||Fisher Exact|||||||=.065
73897641|NCT04839562|147328356|SUPERIORITY||||||=|0.1144|||||||Fisher Exact|||||||=.1144
73897642|NCT04839562|147328357|SUPERIORITY||||||=|0.2829|||||||Fisher Exact|||||||=.2829
74020470|NCT01227967|147593324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|5.0||0.046|TWO_SIDED|95.0|-19.8|-0.2||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Combination Therapy minus the percent detectable in the Oseltamivir Monotherapy.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Combination Therapy was better than the Oseltamivir Monotherapy and that the detectable rate in the Combination Therapy was 42.5% compared to 57.5% in the Oseltamivir Monotherapy (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.||-0.2|-19.8|0.046
74020471|NCT03403400|147593339|EQUIVALENCE|Comparison of variance|Test Statistics|0.893||||0.64|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between groups in mCTSIB Ha: There is a significant difference between groups in mCTSIB||||.640
73897643|NCT00730028|147328358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.7688|TWO_SIDED|95.0|-7.6|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.||5.1|-7.6|0.7688
73897644|NCT00730028|147328358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||1|TWO_SIDED|95.0|-5.4|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||5.1|-5.4|1.0000
73897645|NCT00730028|147328358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-19.2|-5.6||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.6|-19.2|<0.0001
73897646|NCT00730028|147328358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2||||0.0002|TWO_SIDED|95.0|-19.1|-5.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.4|-19.1|0.0002
73897647|NCT00730028|147328361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.52|TWO_SIDED|95.0|-10.2|4.9||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.||4.9|-10.2|0.5200
73897648|NCT00730028|147328361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.7324|TWO_SIDED|95.0|-8.4|5.7||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||5.7|-8.4|0.7324
73897649|NCT00730028|147328361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2||||0.0001|TWO_SIDED|95.0|-22.0|-6.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-6.4|-22.0|0.0001
73897650|NCT00730028|147328361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9||||0.0008|TWO_SIDED|95.0|-20.8|-5.0||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.0|-20.8|0.0008
73897651|NCT00730028|147328362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.7707|TWO_SIDED|95.0|-7.1|5.3||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||5.3|-7.1|0.7707
73897652|NCT00730028|147328362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.2141|TWO_SIDED|95.0|-2.0|8.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||8.5|-2.0|0.2141
73897653|NCT00730028|147328362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.0593|TWO_SIDED|95.0|-12.4|0.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||0.5|-12.4|0.0593
73897654|NCT00730028|147328362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2||||0.0017|TWO_SIDED|95.0|-15.3|-3.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-3.1|-15.3|0.0017
73897655|NCT00730028|147328363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.1381|TWO_SIDED|95.0|-13.1|1.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||1.8|-13.1|0.1381
73897656|NCT00730028|147328363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.8302|TWO_SIDED|95.0|-6.4|8.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||8.2|-6.4|0.8302
73897657|NCT00730028|147328363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.0838|TWO_SIDED|95.0|-14.3|1.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||1.1|-14.3|0.0838
73897658|NCT00730028|147328363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.0507|TWO_SIDED|95.0|-15.2|0.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||0.2|-15.2|0.0507
73897659|NCT00730028|147328364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.1505|TWO_SIDED|95.0|-13.3|1.9||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||1.9|-13.3|0.1505
73897660|NCT00730028|147328364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1666|TWO_SIDED|95.0|-10.9|2.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||2.2|-10.9|0.1666
73897661|NCT00730028|147328364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.0001|TWO_SIDED|95.0|-23.0|-8.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-8.0|-23.0|<0.0001
73897662|NCT00730028|147328364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1||||0.0046|TWO_SIDED|95.0|-19.0|-3.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-3.2|-19.0|0.0046
73897663|NCT00730028|147328365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.1815|TWO_SIDED|95.0|-13.6|2.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||2.8|-13.6|0.1815
73897664|NCT00730028|147328365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.1552|TWO_SIDED|95.0|-13.2|2.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||2.1|-13.2|0.1552
73897665|NCT00730028|147328365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|||<|0.0001|TWO_SIDED|95.0|-24.0|-7.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-7.8|-24.0|<0.0001
73897666|NCT00730028|147328365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.0145|TWO_SIDED|95.0|-18.7|-2.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-2.0|-18.7|0.0145
73897667|NCT00528970|147328368|OTHER||Mean Difference (Final Values)|2.0||||0.944||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.||||0.944
73897668|NCT00528970|147328368|OTHER||Mean Difference (Final Values)|9.1||||0.208||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.||||0.208
73897669|NCT01976988|147328376|SUPERIORITY_OR_OTHER|||||||0.72|||||||Fisher Exact|||||||0.72
73897670|NCT01976988|147328377|SUPERIORITY_OR_OTHER|||||||0.36|||||||Fisher Exact|||||||0.36
73897671|NCT01976988|147328378|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
73897672|NCT01976988|147328379|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1
73897673|NCT01976988|147328380|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
73897674|NCT01976988|147328381|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
73897675|NCT00853996|147328409|OTHER||||||<|0.001||||||No adjustment for multiple comparisons since this was primary endpoint. A priori threshold for statistical significance was set at \<0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73897676|NCT00853996|147328410|OTHER|||||||0.067||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05.|Wilcoxon (Mann-Whitney)|||||||0.067
73897677|NCT00853996|147328411|OTHER|||||||0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05|Wilcoxon (Mann-Whitney)|||||||0.001
73897678|NCT00853996|147328412|OTHER|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05|Wilcoxon (Mann-Whitney)|||||||0.002
73897679|NCT00853996|147328413|OTHER|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance set at 0.05|Wilcoxon (Mann-Whitney)|||||||0.002
73897680|NCT00770146|147328421|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|Wilcoxon (Mann-Whitney)|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With at least 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 groups.||||<0.001
73897681|NCT00770146|147328423|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)|||||||<0.001
73897682|NCT00770146|147328425|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
73897683|NCT00770146|147328427|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)|||||||<0.001
73897684|NCT00770146|147328429|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
73897685|NCT00770146|147328431|SUPERIORITY_OR_OTHER|||||||0.977||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.977
74020472|NCT03403400|147593339|EQUIVALENCE|Comparison of variance|Test Statistics|0.196||||0.18|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the prescribed walking group and the control group in mCTSIB Ha: There is a significant difference between the prescribed walking group and the control group in mCTSIB||||.18
73897686|NCT00770146|147328433|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
73897687|NCT00770146|147328435|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
73897688|NCT00770146|147328437|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
73897689|NCT00770146|147328439|SUPERIORITY_OR_OTHER|||||||0.032||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.032
73897690|NCT00816023|147328450|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Jonckheere-Terpstra|||||||0.474
73897691|NCT05027971|147328460|OTHER||Proportion by cohort|0.02|||||TWO_SIDED|95.0|0.002|0.07||||||||.07|.002|
73897692|NCT05027971|147328461|OTHER||Proportion by cohort|0.03|||||TWO_SIDED|95.0|0.006|0.084||||||||.084|.006|
73897693|NCT05027971|147328462|OTHER||Proportion by cohort|0.667|||||TWO_SIDED|95.0|0.553|0.768||||||||.768|.553|
73897694|NCT05027971|147328463|OTHER||Mean Difference (Final Values)|-15.8|||||TWO_SIDED|95.0|-17.4|-14.2||||||||-14.2|-17.4|
73897695|NCT05027971|147328466|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
73897696|NCT05027971|147328467|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
73897697|NCT05027971|147328468|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
73897698|NCT05027971|147328469|OTHER||Proportion by cohort|0.889|||||TWO_SIDED|95.0|0.81|0.943||||||||.943|.810|
73897699|NCT05027971|147328470|OTHER||Mean Difference (Final Values)|15.0|||||TWO_SIDED|95.0|11.3|18.6||||||||18.6|11.3|
73897700|NCT05027971|147328471|OTHER||Mean Difference (Final Values)|-3.4|||||TWO_SIDED|95.0|-3.9|-2.9||||||||-2.9|-3.9|
73897701|NCT05027971|147328472|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
73897702|NCT02486627|147328473|NON_INFERIORITY|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|-3.4|||||TWO_SIDED|95.0|-10.0|3.1||||||||3.1|-10|
73897703|NCT02486627|147328474|NON_INFERIORITY|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|11.6|||||TWO_SIDED|95.0|2.7|20.3||||||||20.3|2.7|
73897704|NCT03554486|147328513|OTHER|||||||0.051|||||||t-test, 2 sided|||||||0.051
73897705|NCT03554486|147328514|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
73897706|NCT03554486|147328515|OTHER|||||||0.74|||||||t-test, 2 sided|||||||0.74
73897707|NCT02199717|147328600|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups (mild/moderate versus severe haemophilia) were examined in exploratory analyses.||||0.32
73897708|NCT02199717|147328601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|306.4|||<|0.01|TWO_SIDED|95.0|254.8|358.0|||Wilcoxon (Mann-Whitney)|||||358|254.8|<0.01
73897709|NCT03467685|147328608|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
73897710|NCT00534313|147328634|SUPERIORITY_OR_OTHER||Difference|22.9||||0.022|TWO_SIDED|95.0|4.0|41.8||The p-value (two-sided) was based on Cochran-Mantel-Haenszel method (CMH) with stratification of baseline body surface area (BSA) affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||41.8|4.0|0.022
73897711|NCT00534313|147328634|SUPERIORITY_OR_OTHER||Difference|28.7||||0.006|TWO_SIDED|95.0|9.4|48.0||p-value (two-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||48.0|9.4|0.006
73897712|NCT00534313|147328634|SUPERIORITY_OR_OTHER||Difference|14.6||||0.121|TWO_SIDED|95.0|-3.5|32.6||p-value (2-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||32.6|-3.5|0.121
73897713|NCT00534313|147328641|SUPERIORITY_OR_OTHER||Difference|-6.0|||||TWO_SIDED|95.0|-23.0|11.0|||Cochran-Mantel-Haenszel||Difference and 95% confidence intervals (CI) was based on CMH with stratification of baseline BSA affected by psoriasis.|||11.0|-23.0|
73897714|NCT00534313|147328641|SUPERIORITY_OR_OTHER||Difference|-0.5|||||TWO_SIDED|95.0|-18.0|17.1|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||17.1|-18.0|
73897715|NCT00534313|147328641|SUPERIORITY_OR_OTHER||Difference|10.4|||||TWO_SIDED|95.0|-7.6|28.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||28.5|-7.6|
73897716|NCT00534313|147328642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.77|||||TWO_SIDED|95.0|-7.02|44.56|||ANCOVA|||||44.56|-7.02|
73897717|NCT00534313|147328642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.34|||||TWO_SIDED|95.0|-3.93|48.6|||ANCOVA|||||48.60|-3.93|
73897718|NCT00534313|147328642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.48|||||TWO_SIDED|95.0|4.82|56.15|||ANCOVA|||||56.15|4.82|
73897719|NCT00534313|147328644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.08||||||95.0|-4.79|8.96|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||8.96|-4.79|
73897720|NCT00534313|147328644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.01|||||TWO_SIDED|95.0|-4.94|8.95|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||8.95|-4.94|
73897721|NCT00534313|147328644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|-6.08|7.58|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||7.58|-6.08|
73897722|NCT00534313|147328648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.15|||||TWO_SIDED|95.0|1.97|12.33|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as factor and baseline value as covariate was used for the analysis.||||12.33|1.97|
73897723|NCT00534313|147328648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.12|||||TWO_SIDED|95.0|3.83|14.41|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis||||14.41|3.83|
73897724|NCT00534313|147328648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.17|||||TWO_SIDED|95.0|1.01|11.32|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||11.32|1.01|
73897725|NCT00534313|147328649|SUPERIORITY_OR_OTHER||Difference|16.0|||||TWO_SIDED|95.0|-2.5|34.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||34.5|-2.5|
73897726|NCT00534313|147328649|SUPERIORITY_OR_OTHER||Difference|26.1||||||95.0|6.8|45.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||45.5|6.8|
73897727|NCT00534313|147328649|SUPERIORITY_OR_OTHER||Difference|16.6||||||95.0|-1.8|34.9|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||34.9|-1.8|
73897728|NCT00043550|147328683|SUPERIORITY|The proposed sample size had at least 80% power to detect effect sizes of 0.36 between the two active treatment conditions and placebo during the active phase. These power calculations were based on a priori values of within-subject correlation of 0.50, 10% attrition, and 6 assessment points.|Slope|1.0||||0.95|TWO_SIDED|||||Overall significant effect for treatment, as well as the two moderating effects, used a Bonferroni-corrected alpha level of 0.0167 (0.05/3).|HLM|||Comparison of conditions||||.95
73897729|NCT00043550|147328683|SUPERIORITY||||||<|0.0001|||||||HLM|||effects of conditions over time||||<.0001
73897730|NCT00043550|147328683|SUPERIORITY||Slope|0.03|||||TWO_SIDED|95.0|-0.35|0.41||||||||.41|-.35|
73897731|NCT00043550|147328683|SUPERIORITY||Slope|0.06|||||TWO_SIDED|95.0|-0.33|0.45||||||||.45|-.33|
73897732|NCT01143701|147328688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54|||<|0.05|TWO_SIDED|95.0|-5.89|-1.19|||Mixed Models Analysis|||Utilizing the full sample (n=577), an intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.||-1.19|-5.89|<.05
73897733|NCT01143701|147328689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|||<|0.05|TWO_SIDED|95.0|-4.71|1.75|||Mixed Models Analysis|||An intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.||1.75|-4.71|<0.05
73897734|NCT04157673|147328698|SUPERIORITY|||||||0.0002||||||This is the overall treatment effect from the mixed model. p-value threshold set at p = 0.05.|Mixed Models Analysis|||Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.||||0.0002
73897735|NCT04157673|147328699|OTHER|Effect size of mean differences|Mean Difference (Final Values)|2.75|STANDARD_DEVIATION|3.78|||TWO_SIDED||||||||Cohen's d effect size = 0.73|Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.||||
73897736|NCT04157673|147328700|OTHER|Effect size of mean pre-post differences|Mean Difference (Final Values)|0.355|STANDARD_DEVIATION|0.295|||TWO_SIDED||||||||cohen's d effect size for mean differences pre to post-treatment = 1.20|||||
73897737|NCT01181986|147328750|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence, group (diabetes duration) and time.||||||<0.0001
73897738|NCT01181986|147328750|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANCOVA|Adjusted for treatment sequence.||||||0.006
73897739|NCT01181986|147328750|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|Adjusted for treatment sequence.||||||0.003
73897740|NCT01181986|147328751|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence and diabetes duration group.||||||<0.0001
73897741|NCT01181986|147328752|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73897742|NCT03073733|147328755|SUPERIORITY||least squares mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.9||0.582|TWO_SIDED|95.0|-10.3|5.8|||linear model for repeated measures|||||5.8|-10.3|0.582
73897743|NCT03073733|147328755|SUPERIORITY||least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|2.91||0.984|TWO_SIDED|95.0|-8.2|8.0|||linear model for repeated measures|||||8.0|-8.2|0.984
73897744|NCT03073733|147328756|SUPERIORITY||least squares mean difference|1.2986|STANDARD_ERROR_OF_MEAN|0.8744||0.29|TWO_SIDED|95.0|-1.1341|3.7313|||linear model for repeated measures|||||3.7313|-1.1341|0.290
73897745|NCT03073733|147328756|SUPERIORITY||least squares mean difference|-0.3542|STANDARD_ERROR_OF_MEAN|0.7793||0.759|TWO_SIDED|95.0|-2.6516|1.9433|||linear model for repeated measures|||||1.9433|-2.6516|0.759
73897746|NCT03073733|147328757|SUPERIORITY||least squares mean difference|-278.73|STANDARD_ERROR_OF_MEAN|305.192||0.515|TWO_SIDED|95.0|-1126.21|568.75|||linear model for repeated measures|||||568.75|-1126.21|0.515
73897747|NCT03073733|147328757|SUPERIORITY||least squares mean difference|292.18|STANDARD_ERROR_OF_MEAN|308.659||0.499|TWO_SIDED|95.0|-562.87|1147.23|||linear model for repeated measures|||||1147.23|-562.87|0.499
73897748|NCT03073733|147328758|SUPERIORITY||least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.42||0.16|TWO_SIDED|95.0|-2.1|0.3|||linear model for repeated measures|||||0.3|-2.1|0.160
73836792|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.11|||||TWO_SIDED|95.0|0.56|2.19||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.19|0.56|
73836793|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.58|2.06||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.06|0.58|
73836794|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.46|2.13||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.13|0.46|
73836795|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.38|2.55||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.55|0.38|
73836796|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.23|||||TWO_SIDED|95.0|0.5|3.0||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.00|0.50|
73897749|NCT03073733|147328758|SUPERIORITY||least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.43||0.622|TWO_SIDED|95.0|-1.5|0.9|||linear model for repeated measures|||||0.9|-1.5|0.622
73897750|NCT03073733|147328759|SUPERIORITY||least squares mean difference|-0.111|STANDARD_ERROR_OF_MEAN|0.1038||0.442|TWO_SIDED|95.0|-0.399|0.176|||linear model for repeated measures|||||0.176|-0.399|0.442
73897751|NCT03073733|147328759|SUPERIORITY||least squares mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.1037||0.401|TWO_SIDED|95.0|-0.165|0.409|||linear model for repeated measures|||||0.409|-0.165|0.401
73897752|NCT03073733|147328761|SUPERIORITY|||||||0.205|||||||Fisher Exact|||||||0.205
73897753|NCT03073733|147328762|SUPERIORITY|||||||0.157|||||||Fisher Exact|||||||0.157
73897754|NCT03073733|147328763|SUPERIORITY|||||||0.125|||||||Fisher Exact|||||||0.125
73897755|NCT03073733|147328764|SUPERIORITY|||||||0.173|||||||Fisher Exact|||||||0.173
73897756|NCT03073733|147328765|SUPERIORITY|||||||0.099|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.2)||||||0.099
73836797|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.25|||||TWO_SIDED|95.0|0.42|3.72||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.72|0.42|
73836798|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.69|||||TWO_SIDED|95.0|0.29|1.68||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.68|0.29|
73836799|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.92|||||TWO_SIDED|95.0|0.4|2.1||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.10|0.40|
73836800|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.33|||||TWO_SIDED|95.0|0.49|3.64||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.64|0.49|
73836801|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.7|||||TWO_SIDED|95.0|0.7|4.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.12|0.70|
73836802|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.37|||||TWO_SIDED|95.0|0.6|3.14||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.14|0.60|
73836803|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.81|||||TWO_SIDED|95.0|0.3|2.21||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.21|0.30|
73836804|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.43|1.89||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.89|0.43|
73836805|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.83|||||TWO_SIDED|95.0|0.42|1.67||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.67|0.42|
73836806|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.93|||||TWO_SIDED|95.0|0.4|2.16||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.16|0.40|
73836807|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|7.53|||||TWO_SIDED|95.0|2.86|19.78||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||19.78|2.86|
73836808|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.53|||||TWO_SIDED|95.0|0.22|1.31||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.31|0.22|
73836809|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.07|||||TWO_SIDED|95.0|0.02|0.21||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.21|0.02|
73836810|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.11|||||TWO_SIDED|95.0|0.53|2.3||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.30|0.53|
73836811|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.5|1.97||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.97|0.50|
73836812|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.39|2.07||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.07|0.39|
73836813|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|4.2|||||TWO_SIDED|95.0|2.18|8.09||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||8.09|2.18|
73836814|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.61|||||TWO_SIDED|95.0|0.33|1.13||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.33|
73836815|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.15|||||TWO_SIDED|95.0|0.07|0.31||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.31|0.07|
73836816|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|3.11|||||TWO_SIDED|95.0|1.51|6.4||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||6.40|1.51|
73836817|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.88|||||TWO_SIDED|95.0|0.96|3.69||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.69|0.96|
73836818|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.6|||||TWO_SIDED|95.0|0.27|1.37||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.27|
73970922|NCT04103580|147481871|SUPERIORITY||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.635|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 2.||||0.635
73836819|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|2.88|||||TWO_SIDED|95.0|1.39|5.98||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||5.98|1.39|
73836820|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.15|||||TWO_SIDED|95.0|0.58|2.28||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.28|0.58|
73897757|NCT03073733|147328765|SUPERIORITY|||||||0.13|||||||t-test, 1 sided|Pooled t-test (variance ratio of 1.9)||||||0.130
73897758|NCT03073733|147328766|SUPERIORITY|||||||0.0959|||||||Fisher Exact|||||||0.0959
73897759|NCT03073733|147328767|SUPERIORITY|||||||0.1868|||||||Fisher Exact|||||||0.1868
73897760|NCT03073733|147328768|SUPERIORITY|||||||0.608|||||||Fisher Exact|||||||0.608
73897761|NCT03073733|147328769|SUPERIORITY|||||||0.264|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 7.9)||||||0.264
73897762|NCT03073733|147328769|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 25.9)||||||0.139
73897763|NCT03073733|147328770|SUPERIORITY|||||||0.261|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 7.9)||||||0.261
73897764|NCT03073733|147328770|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 6.3)||||||0.139
73897765|NCT03073733|147328771|SUPERIORITY|||||||0.35|||||||t-test, 1 sided|Pooled t-test (variance ratio of 0.8).||||||0.350
73897766|NCT03073733|147328771|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.5)||||||0.500
73897767|NCT03073733|147328772|SUPERIORITY|||||||0.22|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.9).||||||0.220
73897768|NCT03073733|147328772|SUPERIORITY|||||||0.119|||||||t-test, 1 sided|Pooled t-test (variance ratio of 1.9).||||||0.119
73897769|NCT03073733|147328773|SUPERIORITY|||||||0.006|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.7)||||||0.006
73897770|NCT03073733|147328774|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
73897771|NCT03073733|147328775|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
73897772|NCT03073733|147328776|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.010
73897773|NCT03073733|147328777|SUPERIORITY|||||||0.072|||||||Fisher Exact|||||||0.072
73897774|NCT03073733|147328778|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 5.9)||||||0.019
73897775|NCT03073733|147328778|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.98)||||||0.019
73897776|NCT03073733|147328779|SUPERIORITY|||||||0.013|||||||Fisher Exact|||||||0.013
73897777|NCT03073733|147328780|SUPERIORITY|||||||0.033|||||||Fisher Exact|||||||0.033
73897778|NCT03073733|147328781|SUPERIORITY|||||||0.199|||||||Fisher Exact|||||||0.199
73897779|NCT03073733|147328782|SUPERIORITY|||||||0.075|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 56.3)||||||0.075
73897780|NCT03073733|147328782|SUPERIORITY|||||||0.062|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 25.2)||||||0.062
73897781|NCT03073733|147328783|SUPERIORITY|||||||0.255|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 9.9)||||||0.255
73897782|NCT03073733|147328783|SUPERIORITY|||||||0.109|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 8.7)||||||0.109
73897783|NCT03073733|147328784|SUPERIORITY|||||||0.488|||||||t-test, 1 sided|Pooled t-test (variance ratio of 0.7).||||||0.488
73897784|NCT03073733|147328784|SUPERIORITY|||||||0.273|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.5)||||||0.273
73897785|NCT03073733|147328785|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
73897786|NCT03073733|147328786|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
73897787|NCT03073733|147328787|SUPERIORITY|||||||0.016|||||||Fisher Exact|||||||0.016
73897788|NCT03073733|147328788|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
73897789|NCT03073733|147328789|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 8.2)||||||0.019
73897790|NCT03073733|147328789|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 4.7)||||||0.011
73897791|NCT03073733|147328790|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
73897792|NCT03073733|147328791|SUPERIORITY|||||||0.096|||||||Fisher Exact|||||||0.096
73897793|NCT03073733|147328792|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.480
73897794|NCT03073733|147328793|SUPERIORITY|||||||0.076|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 51.5)||||||0.076
73897795|NCT03073733|147328793|SUPERIORITY|||||||0.057|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 26.1)||||||0.057
73897796|NCT03073733|147328794|SUPERIORITY|||||||0.117|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 29.0)||||||0.117
73897797|NCT03073733|147328794|SUPERIORITY|||||||0.083|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 9.5)||||||0.083
73897798|NCT03073733|147328795|SUPERIORITY|||||||0.172|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 6.7)||||||0.172
73897799|NCT03073733|147328795|SUPERIORITY|||||||0.14|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.98)||||||0.140
73897800|NCT03073733|147328796|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 5.4).||||||0.011
73897801|NCT03073733|147328797|SUPERIORITY|||||||0.0406|||||||Fisher Exact|||||||0.0406
73897802|NCT03073733|147328798|SUPERIORITY|||||||0.007|||||||Fisher Exact|||||||0.007
73897803|NCT03073733|147328799|SUPERIORITY|||||||0.026|||||||Fisher Exact|||||||0.026
73897804|NCT03073733|147328800|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
73897805|NCT03073733|147328801|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 22.2)||||||0.030
73897806|NCT03073733|147328801|SUPERIORITY|||||||0.033|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.3)||||||0.033
73897807|NCT03073733|147328802|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
73897808|NCT03073733|147328803|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
73897809|NCT03073733|147328804|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73897810|NCT03073733|147328805|SUPERIORITY|||||||0.08|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 606.4)||||||0.080
73897811|NCT03073733|147328805|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 52.3)||||||0.050
73897812|NCT03073733|147328806|SUPERIORITY|||||||0.099|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 35.7)||||||0.099
73897813|NCT03073733|147328806|SUPERIORITY|||||||0.076|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 17.6)||||||0.076
73897814|NCT03073733|147328807|SUPERIORITY|||||||0.1099|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 4.5)||||||0.1099
73897815|NCT03073733|147328807|SUPERIORITY|||||||0.012|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 14.3)||||||0.012
73897816|NCT00167778|147328818|SUPERIORITY_OR_OTHER||||||>|0.99||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||>0.99
73897817|NCT00167778|147328819|SUPERIORITY_OR_OTHER||||||=|0.09||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.09
73897818|NCT00167778|147328820|SUPERIORITY_OR_OTHER||||||=|0.09||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.09
73897819|NCT00167778|147328821|SUPERIORITY_OR_OTHER||||||=|0.7||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.7
73897820|NCT00167778|147328822|SUPERIORITY_OR_OTHER||||||>|0.99||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||>0.99
73897821|NCT00167778|147328824|SUPERIORITY_OR_OTHER||||||=|0.8||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.8
73897822|NCT00167778|147328825|SUPERIORITY_OR_OTHER||||||=|0.7||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.7
73897823|NCT00167778|147328826|SUPERIORITY_OR_OTHER||||||=|0.4||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=.4
73897824|NCT00167778|147328827|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
73897825|NCT00167778|147328828|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
73897826|NCT00167778|147328829|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
73897827|NCT00167778|147328830|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
73897828|NCT00167778|147328831|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
73897829|NCT00167778|147328832|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
73897830|NCT00167778|147328833|SUPERIORITY_OR_OTHER||||||=|0.13||95.0||||Statistical significance was set a-prior at p\<0.05.|Wilcoxon (Mann-Whitney)|Wilcoon paired signed rank test for the differences between Rigid and Torsion Adapter pylons||||||=0.13
73897831|NCT00167778|147328834|SUPERIORITY_OR_OTHER||||||=|0.92||95.0||||Statistical significance was set a-prior at p\<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between Rigid and Torsion Adapter pylons.||||||=0.92
73897832|NCT00167778|147328835|SUPERIORITY_OR_OTHER||||||=|0.37||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.37
73897833|NCT00167778|147328836|SUPERIORITY_OR_OTHER||||||=|0.27||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.27
73897834|NCT00167778|147328837|SUPERIORITY_OR_OTHER||||||=|0.2||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.20
73897835|NCT00167778|147328838|SUPERIORITY_OR_OTHER||||||=|0.59||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.59
73897836|NCT00167778|147328839|SUPERIORITY_OR_OTHER||||||=|0.057||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.057
73897837|NCT00167778|147328840|SUPERIORITY_OR_OTHER||||||=|0.78||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.78
73897838|NCT02880956|147328857|SUPERIORITY||Least Squares (LS) Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.178||0.74|TWO_SIDED|95.0|-0.291|0.409||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.409|-0.291|0.740
73897839|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.38|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897840|NCT02880956|147328857|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.176||0.367|TWO_SIDED|95.0|-0.504|0.187||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.187|-0.504|0.367
73897841|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897842|NCT02880956|147328857|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.18||0.843|TWO_SIDED|95.0|-0.318|0.389||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.389|-0.318|0.843
73897843|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.37|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897844|NCT02880956|147328857|SUPERIORITY||LS Mean of Difference|0.08|STANDARD_ERROR_OF_MEAN|0.222||0.703|TWO_SIDED|95.0|-0.351|0.52||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.520|-0.351|0.703
73897845|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|1.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897846|NCT02880956|147328857|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.218||0.947|TWO_SIDED|95.0|-0.442|0.413||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.413|-0.442|0.947
73897847|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.69|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897848|NCT02880956|147328857|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.222||0.732|TWO_SIDED|95.0|-0.514|0.361||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.361|-0.514|0.732
73897849|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897850|NCT02880956|147328857|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.305||0.939|TWO_SIDED|95.0|-0.623|0.576||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.576|-0.623|0.939
73897851|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|2.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897852|NCT02880956|147328857|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.299||0.872|TWO_SIDED|95.0|-0.637|0.54||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.540|-0.637|0.872
73897853|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897854|NCT02880956|147328857|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.305||0.773|TWO_SIDED|95.0|-0.688|0.512||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.512|-0.688|0.773
73897855|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897856|NCT02880956|147328857|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.387||0.848|TWO_SIDED|95.0|-0.834|0.686||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.686|-0.834|0.848
73897857|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|2.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897858|NCT02880956|147328857|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.38||0.869|TWO_SIDED|95.0|-0.81|0.684||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.684|-0.810|0.869
73897859|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897860|NCT02880956|147328857|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.389||0.679|TWO_SIDED|95.0|-0.603|0.925||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.925|-0.603|0.679
73897861|NCT02880956|147328857|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|2.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897862|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.693||0.562|TWO_SIDED|95.0|-1.764|0.96||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.960|-1.764|0.562
73897863|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|4.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897864|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.682||0.066|TWO_SIDED|95.0|-2.602|0.081||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.081|-2.602|0.066
73897865|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|5.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897866|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.7||0.962|TWO_SIDED|95.0|-1.343|1.41||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.410|-1.343|0.962
73897867|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|5.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897868|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.887||0.265|TWO_SIDED|95.0|-2.734|0.755||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.755|-2.734|0.265
73897869|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|6.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897870|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.863||0.212|TWO_SIDED|95.0|-2.775|0.618||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.618|-2.775|0.212
73897871|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|6.29|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897872|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.893||0.602|TWO_SIDED|95.0|-2.223|1.29||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.290|-2.223|0.602
73897873|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|6.35|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897874|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.019||0.635|TWO_SIDED|95.0|-2.489|1.519||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.519|-2.489|0.635
73897875|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|6.31|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897876|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.003||0.795|TWO_SIDED|95.0|-2.233|1.712||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.712|-2.233|0.795
73970923|NCT00104676|147481881|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.05|TWO_SIDED|95.0|0.44|1.0|||Log Rank|Adjusted on the stratification factor (treatment centers)||To detect an absolute difference of 20% in progression-free survival at 3-years between Arm I and Unfav-Dose-Dense Arm II (46% versus 66%) with the possibility that 80 events (progressive disease and death) may be observed during this period, a total of 196 participants, 98 per group needed to be included, with an additional 25% of patients for a total of 260 participants required.||1.00|0.44|0.05
73897877|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|7.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897878|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|1.11|STANDARD_ERROR_OF_MEAN|1.027||0.281|TWO_SIDED|95.0|-0.91|3.128||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||3.128|-0.910|0.281
73897879|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|7.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897880|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.261||0.729|TWO_SIDED|95.0|-2.918|2.043||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.043|-2.918|0.729
73897881|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|7.4|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897882|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|1.248||0.636|TWO_SIDED|95.0|-3.047|1.863||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.863|-3.047|0.636
73970924|NCT00104676|147481882|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.34|TWO_SIDED|95.0|0.46|1.31|||Log Rank|Adjusted on the stratification factor (treatment centers)||||1.31|0.46|0.34
73897883|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|7.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897884|NCT02880956|147328866|SUPERIORITY||LS Mean of Difference|1.03|STANDARD_ERROR_OF_MEAN|1.294||0.427|TWO_SIDED|95.0|-1.515|3.575||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||3.575|-1.515|0.427
73897885|NCT02880956|147328866|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|7.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897886|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.69|TWO_SIDED|95.0|-0.083|0.126||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.126|-0.083|0.690
73897887|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|0.39|||TWO_SIDED|95.0|||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897888|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.052||0.595|TWO_SIDED|95.0|-0.075|0.131||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.131|-0.075|0.595
73897889|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|0.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897890|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.054||0.201|TWO_SIDED|95.0|0.037|0.175||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.175|0.037|0.201
73897891|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|0.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73970925|NCT02675777|147481941|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73970926|NCT02675777|147481942|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.30
73970927|NCT00691002|147481948|SUPERIORITY||Odds Ratio (OR)|1.28||||0.11|TWO_SIDED|95.0|0.94|1.74|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus calcipotriol ointment at Week 8 LOCF (Last Observation Carried Forward).||1.74|0.94|0.11
73897892|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.064||0.361|TWO_SIDED|95.0|-0.067|0.184||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.184|-0.067|0.361
73897893|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897894|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.062||0.522|TWO_SIDED|95.0|-0.082|0.162||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|Week 48||0.162|-0.082|0.522
73897895|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|0.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897896|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|0.09|STANDARD_ERROR_OF_MEAN|0.064||0.147|TWO_SIDED|95.0|-0.033|0.219||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.219|-0.033|0.147
73897897|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|0.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897898|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.091||0.492|TWO_SIDED|95.0|-0.243|0.117||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.117|-0.243|0.492
73897899|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|0.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897900|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.691|TWO_SIDED|95.0|-0.213|0.141||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.141|-0.213|0.691
73897901|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897902|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.091||0.135|TWO_SIDED|95.0|-0.043|0.317||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.317|-0.043|0.135
73897903|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897904|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.117||0.713|TWO_SIDED|95.0|-0.273|0.187||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.187|-0.273|0.713
73897905|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897906|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.115||0.318|TWO_SIDED|95.0|-0.341|0.111||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.111|-0.341|0.318
73897907|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897908|NCT02880956|147328867|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.119||0.927|TWO_SIDED|95.0|-0.244|0.222||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.222|-0.244|0.927
73897909|NCT02880956|147328867|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.84|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897910|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.081||0.456|TWO_SIDED|95.0|-0.219|0.098||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.098|-0.219|0.456
73897911|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897912|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.079||0.093|TWO_SIDED|95.0|-0.29|0.023||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.023|-0.290|0.093
73970928|NCT00691002|147481948|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.31|2.45|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus hydrocortisone ointment at Week 8 LOCF (Last Observation Carried Forward).||2.45|1.31|<0.001
73897913|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.59|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897914|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.082||0.75|TWO_SIDED|95.0|-0.187|0.135||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.135|-0.187|0.750
73897915|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897916|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.106||0.134|TWO_SIDED|95.0|-0.049|0.366||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.366|-0.049|0.134
73897917|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897918|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.103||0.316|TWO_SIDED|95.0|-0.099|0.305||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.305|-0.099|0.316
73897919|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|0.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897920|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.106||0.218|TWO_SIDED|95.0|-0.078|0.339||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.339|-0.078|0.218
73897921|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897922|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.099||0.799|TWO_SIDED|95.0|-0.219|0.169||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.169|-0.219|0.799
73897923|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897924|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.098||0.406|TWO_SIDED|95.0|-0.273|0.111||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.111|-0.273|0.406
73897925|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897926|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.099||0.363|TWO_SIDED|95.0|-0.285|0.105||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.105|-0.285|0.363
73897927|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897928|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.125||0.22|TWO_SIDED|95.0|-0.4|0.093||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.093|-0.400|0.220
73897929|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897930|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.123||0.245|TWO_SIDED|95.0|-0.386|0.099||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.099|-0.386|0.245
73897931|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897932|NCT02880956|147328868|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.127||0.569|TWO_SIDED|95.0|-0.323|0.178||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.178|-0.323|0.569
73970929|NCT00691002|147481948|SUPERIORITY||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.8|4.04|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus ointment vehicle at Week 8 LOCF (Last Observation Carried Forward).||4.04|1.80|<0.001
74020473|NCT03403400|147593340|EQUIVALENCE|comparison of variance|Test Statistics|0.803||||0.67|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in TUG Ha: There is a significant difference between the groups in TUG||||.67
74080981|NCT02997176|147713966|OTHER|Bioequivalence|Percent Ratio of Geometric Means|149.39|||||TWO_SIDED|90.0|91.49|243.93||||||AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||243.93|91.49|
73897933|NCT02880956|147328868|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897934|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.093||0.945|TWO_SIDED|95.0|-0.177|0.19||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.190|-0.177|0.945
73897935|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.86|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897936|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.092||0.974|TWO_SIDED|95.0|-0.184|0.178||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.178|-0.184|0.974
73897937|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897938|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.094||0.963|TWO_SIDED|95.0|-0.19|0.181||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||||0.181|-0.190|0.963
73897939|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897940|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.104||0.625|TWO_SIDED|95.0|-0.255|0.154||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.154|-0.255|0.625
73897941|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897942|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.468|TWO_SIDED|95.0|-0.272|0.125||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.125|-0.272|0.468
73897943|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897944|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.104||0.636|TWO_SIDED|95.0|-0.155|0.254||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.254|-0.155|0.636
73897945|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897946|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.112||0.887|TWO_SIDED|95.0|-0.204|0.236||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.236|-0.204|0.887
73897947|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.84|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897948|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.111||0.016|TWO_SIDED|95.0|0.051|0.486||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.486|0.051|0.016
73897949|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|-0.33|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897950|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.112||0.272|TWO_SIDED|95.0|-0.097|0.342||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.342|-0.097|0.272
73897951|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897952|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.145||0.671|TWO_SIDED|95.0|-0.223|0.347||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.347|-0.223|0.671
73897953|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897954|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.143||0.493|TWO_SIDED|95.0|-0.183|0.378||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.378|-0.183|0.493
73897955|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|0.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897956|NCT02880956|147328869|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.147||0.501|TWO_SIDED|95.0|-0.19|0.387||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.387|-0.190|0.501
73897957|NCT02880956|147328869|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|0.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897958|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.188||0.742|TWO_SIDED|95.0|-0.307|0.431||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.431|-0.307|0.742
73897959|NCT02880956|147328870|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897960|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.185||0.431|TWO_SIDED|95.0|-0.511|0.218||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.218|-0.511|0.431
73897961|NCT02880956|147328870|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897962|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.29|TWO_SIDED|95.0|-0.574|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.172|-0.574|0.290
73897963|NCT02880956|147328870|SUPERIORITY||effect size|0.13|STANDARD_DEVIATION|1.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897964|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.191||0.541|TWO_SIDED|95.0|-0.492|0.258||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.258|-0.492|0.541
74020474|NCT03403400|147593340|EQUIVALENCE|comparison of variance|Test Statistics|0.14||||0.71|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference in TUG between the prescribed walking and control group Ha: There is a significant difference in TUG between the prescribed walking and control group||||.71
73897965|NCT02880956|147328870|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897966|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.186||0.617|TWO_SIDED|95.0|-0.459|0.272||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.272|-0.459|0.617
73897967|NCT02880956|147328870|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897968|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.457|TWO_SIDED|95.0|-0.517|0.233||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.233|-0.517|0.457
73897969|NCT02880956|147328870|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897970|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|0.22|STANDARD_ERROR_OF_MEAN|0.188||0.245|TWO_SIDED|95.0|-0.151|0.59||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.590|-0.151|0.245
73897971|NCT02880956|147328870|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897972|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.187||0.491|TWO_SIDED|95.0|-0.238|0.496||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.496|-0.238|0.491
73897973|NCT02880956|147328870|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|1.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897974|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|0.28|STANDARD_ERROR_OF_MEAN|0.188||0.132|TWO_SIDED|95.0|-0.085|0.652||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.652|-0.085|0.132
73897975|NCT02880956|147328870|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|1.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897976|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.19||0.751|TWO_SIDED|95.0|-0.434|0.313||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.313|-0.434|0.751
73897977|NCT02880956|147328870|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|1.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897978|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.188||0.157|TWO_SIDED|95.0|-0.635|0.103||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.103|-0.635|0.157
73897979|NCT02880956|147328870|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|1.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73897980|NCT02880956|147328870|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.192||0.283|TWO_SIDED|95.0|-0.585|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.172|-0.585|0.283
73897981|NCT02880956|147328870|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|1.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897982|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.363|TWO_SIDED|95.0|-0.085|0.231||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.231|-0.085|0.363
74020475|NCT03403400|147593341|EQUIVALENCE|Comparison of variance|Test Statistics|0.803|STANDARD_DEVIATION|1.79||0.67|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in DGI Ha: There is a significant difference between the groups in DGI||||.67
73897983|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73970930|NCT04324359|147481953|SUPERIORITY||||||<|0.001|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on the normal approximation test for differences between proportions.||||||<0.001
73970931|NCT04324359|147481954|SUPERIORITY|||||||0.066|||||||Other: z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.066
74020476|NCT03403400|147593341|EQUIVALENCE|comparison of variance|Test Statistics|0.66||||0.42|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the prescribed walking group and the control group in DGI Ha: There is a significant difference between the prescribed walking group and control group in DGI||||.42
73897984|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.079||0.688|TWO_SIDED|95.0|-0.188|0.124||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.124|-0.188|0.688
73897985|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897986|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.081||0.137|TWO_SIDED|95.0|-0.039|0.281||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.281|-0.039|0.137
73897987|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|0.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73897988|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.107||0.408|TWO_SIDED|95.0|-0.3|0.122||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.122|-0.300|0.408
73897989|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897990|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.104||0.249|TWO_SIDED|95.0|-0.325|0.085||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.085|-0.325|0.249
73897991|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897992|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.107||0.616|TWO_SIDED|95.0|-0.265|0.157||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.157|-0.265|0.616
73897993|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73897994|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.119||0.555|TWO_SIDED|95.0|-0.163|0.304||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.304|-0.163|0.555
73897995|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897996|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.117||0.815|TWO_SIDED|95.0|-0.203|0.258||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.258|-0.203|0.815
73897997|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|0.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73897998|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.119||0.138|TWO_SIDED|95.0|-0.057|0.409||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.409|-0.057|0.138
73897999|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898000|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.157||0.573|TWO_SIDED|95.0|-0.397|0.22||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.220|-0.397|0.573
73898001|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898002|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.154||0.689|TWO_SIDED|95.0|-0.241|0.365||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.365|-0.241|0.689
73898003|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898004|NCT02880956|147328871|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.159||0.662|TWO_SIDED|95.0|-0.243|0.382||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.382|-0.243|0.662
73898005|NCT02880956|147328871|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|1.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73958944|NCT01212757|147453584|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|13.4||||0.006|TWO_SIDED|95.0|4.0|22.7|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||22.7|4.0|0.0060
73958945|NCT01212757|147453584|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.7||||0.0002|TWO_SIDED|95.0|9.1|28.2|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||28.2|9.1|0.0002
73958946|NCT01212757|147453585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14||||0.0042|TWO_SIDED|95.0|-0.236|-0.045|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.045|-0.236|0.0042
73958947|NCT01212757|147453585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.104||||0.032|TWO_SIDED|95.0|-0.199|-0.009|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.009|-0.199|0.0320
73958948|NCT01212757|147453586|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.2||||0.0394|TWO_SIDED|95.0|0.5|17.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.8|0.5|0.0394
73958949|NCT01212757|147453586|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|15.7||||0.0009|TWO_SIDED|95.0|6.7|24.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.7|6.7|0.0009
73958950|NCT01212757|147453587|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.121||||0.0191|TWO_SIDED|95.0|-0.222|-0.02|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-0.020|-0.222|0.0191
73958951|NCT01212757|147453587|SUPERIORITY||LS Mean Difference|-0.08||||0.1179|TWO_SIDED|95.0|-0.18|0.02|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||0.020|-0.180|0.1179
73958952|NCT01212757|147453588|SUPERIORITY||LS Mean Difference|2.1||||0.0237|TWO_SIDED|95.0|0.28|3.92|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above||3.92|0.28|0.0237
73958953|NCT01212757|147453588|SUPERIORITY||LS Mean Difference|1.36||||0.1388|TWO_SIDED|95.0|-0.44|3.15|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above||3.15|-0.44|0.1388
73958954|NCT01212757|147453589|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.9||||0.0065|TWO_SIDED|95.0|4.3|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||25.5|4.3|0.0065
73970932|NCT04324359|147481955|SUPERIORITY|||||||0.716|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.716
73970933|NCT04324359|147481956|SUPERIORITY|||||||0.528|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level P-value: based on Barnard's exact test for differences between proportions.||||||0.528
74020477|NCT03403400|147593342|EQUIVALENCE|comparison of variance|Test Statistics|4.386||||0.11|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in DHI Ha: There is a significant difference between the groups in DHI||||.11
73898006|NCT02880956|147328872|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.184||0.291|TWO_SIDED|95.0|-0.555|0.167||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.167|-0.555|0.291
73898007|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|1.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898008|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|-0.36|STANDARD_ERROR_OF_MEAN|0.182||0.051|TWO_SIDED|95.0|-0.713|0.001||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.001|-0.713|0.051
73898009|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|1.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898010|NCT02880956|147328872|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.185||0.921|TWO_SIDED|95.0|-0.346|0.383||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.383|-0.346|0.921
73898011|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898012|NCT02880956|147328872|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.211||0.163|TWO_SIDED|95.0|-0.711|0.12||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.120|-0.711|0.163
73898013|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898014|NCT02880956|147328872|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.205||0.424|TWO_SIDED|95.0|-0.567|0.239||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.239|-0.567|0.424
73898015|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898016|NCT02880956|147328872|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.213||0.664|TWO_SIDED|95.0|-0.51|0.326||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.326|-0.510|0.664
73898017|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898018|NCT02880956|147328872|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.229||0.417|TWO_SIDED|95.0|-0.638|0.265||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.265|-0.638|0.417
73898019|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898020|NCT02880956|147328872|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.227||0.217|TWO_SIDED|95.0|-0.727|0.166||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.166|-0.727|0.217
73898021|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|1.68|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898022|NCT02880956|147328872|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.231||0.753|TWO_SIDED|95.0|-0.381|0.526||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.526|-0.381|0.753
73898023|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898024|NCT02880956|147328872|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.257||0.362|TWO_SIDED|95.0|-0.74|0.27||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.270|-0.740|0.362
73898025|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|1.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73970934|NCT04324359|147481957|SUPERIORITY|||||||0.766|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.766
74080982|NCT02997176|147713966|OTHER|Bioequivalence|Percent Ratio of Geometric Means|111.04|||||TWO_SIDED|90.0|60.91|202.43||||||AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||202.43|60.91|
73958955|NCT01212757|147453589|SUPERIORITY||Adjusted Difference|14.7||||0.0071|TWO_SIDED|95.0|4.1|25.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||25.2|4.1|0.0071
73958956|NCT01212757|147453590|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9||||0.0648|TWO_SIDED|95.0|-10.0|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.3|-10.0|0.0648
73958957|NCT01212757|147453590|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.5||||0.0347|TWO_SIDED|95.0|-10.6|-0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.4|-10.6|0.0347
73958958|NCT01212757|147453591|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.3496|TWO_SIDED|95.0|-1.2|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.4|-1.2|0.3496
73958959|NCT01212757|147453591|SUPERIORITY||LS Mean Difference|0.1||||0.8874|TWO_SIDED|95.0|-0.7|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.8|-0.7|0.8874
73958960|NCT01212757|147453592|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.5438|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.5|-1.0|0.5438
73958961|NCT01212757|147453592|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.3759|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||1.0|-0.4|0.3759
73898026|NCT02880956|147328872|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.256||0.78|TWO_SIDED|95.0|-0.432|0.575||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.575|-0.432|0.780
73898027|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898028|NCT02880956|147328872|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.263||0.974|TWO_SIDED|95.0|-0.526|0.509||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.509|-0.526|0.974
73898029|NCT02880956|147328872|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898030|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.139||0.976|TWO_SIDED|95.0|-0.269|0.278||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.278|-0.269|0.976
73898031|NCT02880956|147328873|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.1|||TWO_SIDED|||||||||Week 24||||
73898032|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.137||0.85|TWO_SIDED|95.0|-0.244|0.296||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.296|-0.244|0.850
73898033|NCT02880956|147328873|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898034|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.981|TWO_SIDED|95.0|-0.281|0.275||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.275|-0.281|0.981
73898035|NCT02880956|147328873|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.05|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898036|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.163||0.989|TWO_SIDED|95.0|-0.323|0.318||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.318|-0.323|0.989
73898037|NCT02880956|147328873|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898038|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.159||0.97|TWO_SIDED|95.0|-0.319|0.307||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.307|-0.319|0.970
73898039|NCT02880956|147328873|SUPERIORITY||effect size|0.0|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73958962|NCT01212757|147453593|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.51||||0.0035|TWO_SIDED|95.0|-5.86|-1.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-1.16|-5.86|0.0035
73970935|NCT04324359|147481958|SUPERIORITY|||||||0.619|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.619
73958963|NCT01212757|147453593|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.45||||0.0002|TWO_SIDED|95.0|-6.76|-2.14|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.14|-6.76|0.0002
73958964|NCT01212757|147453594|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.0004|TWO_SIDED|95.0|-0.61|-0.18|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.18|-0.61|0.0004
73958965|NCT01212757|147453594|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.25|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.25|-0.68|<0.0001
73958966|NCT01212757|147453595|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.12||||0.0318|TWO_SIDED|95.0|0.19|4.06|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.06|0.19|0.0318
73958967|NCT01212757|147453595|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27||||0.7803|TWO_SIDED|95.0|-1.65|2.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||2.20|-1.65|0.7803
73958968|NCT01212757|147453596|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.86||||0.0473|TWO_SIDED|95.0|0.02|3.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.70|0.02|0.0473
73958969|NCT01212757|147453596|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.53||||0.0997|TWO_SIDED|95.0|-0.29|3.35|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.35|-0.29|0.0997
73958970|NCT01212757|147453597|SUPERIORITY||Adjusted Difference|7.8||||0.1195|TWO_SIDED|95.0|-1.9|17.5||The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.5|-1.9|0.1195
73958971|NCT01212757|147453597|SUPERIORITY||Adjusted Difference|15.5||||0.0026|TWO_SIDED|95.0|5.6|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||25.5|5.6|0.0026
73958972|NCT01212757|147453598|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.7||||0.5067|TWO_SIDED|95.0|-6.8|3.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.4|-6.8|0.5067
73958973|NCT01212757|147453598|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-3.5||||0.1762|TWO_SIDED|95.0|-8.5|1.6|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||1.6|-8.5|0.1762
73958974|NCT01212757|147453599|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.2719|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.3|-1.2|0.2719
73958975|NCT01212757|147453599|SUPERIORITY||LS Mean Difference|0.0||||0.9727|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.7|-0.8|0.9727
73958976|NCT01212757|147453600|SUPERIORITY||LS Mean Difference|-0.3||||0.3705|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.4|-1.0|0.3705
73958977|NCT01212757|147453600|SUPERIORITY||LS Mean Difference|0.1||||0.6777|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.8|-0.6|0.6777
73958978|NCT01212757|147453601|SUPERIORITY||LS Mean Difference|-3.14||||0.0097|TWO_SIDED|95.0|-5.52|-0.76|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.76|-5.52|0.0097
73958979|NCT01212757|147453601|SUPERIORITY||LS Mean Difference|-4.5||||0.0002|TWO_SIDED|95.0|-6.85|-2.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.16|-6.85|0.0002
74020478|NCT03403400|147593342|EQUIVALENCE|comparison of variance|Test Statistics|4.351||||0.04|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference in DHI between the prescribed walking group and the control group Ha: There is a significant difference in DHI between the prescribed walking group and the control group||||.04
73958980|NCT01212757|147453602|SUPERIORITY||LS Mean Difference|-0.38||||0.0011|TWO_SIDED|95.0|-0.6|-0.15|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.15|-0.60|0.0011
73958981|NCT01212757|147453602|SUPERIORITY||LS Mean Difference|-0.45||||0.0001|TWO_SIDED|95.0|-0.68|-0.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.23|-0.68|0.0001
73958982|NCT01212757|147453603|SUPERIORITY||LS Mean Difference|2.14||||0.0303|TWO_SIDED|95.0|0.2|4.07|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.07|0.20|0.0303
73958983|NCT01212757|147453603|SUPERIORITY||LS mean Difference|0.16||||0.8704|TWO_SIDED|95.0|-1.76|2.08|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||2.08|-1.76|0.8704
73958984|NCT01212757|147453604|SUPERIORITY||Adjusted Difference|3.6||||0.6022|TWO_SIDED|95.0|-9.9|17.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.|||17.2|-9.9|0.6022
74020479|NCT01763164|147593346|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||Hazard ratio was obtained from the stratified unadjusted Cox model. P-value was obtained from the one-sided stratified log-rank test.||0.80|0.47|< 0.001
73898040|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.164||0.215|TWO_SIDED|95.0|-0.526|0.119||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.119|-0.526|0.215
73898041|NCT02880956|147328873|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|1.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898042|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.163||0.665|TWO_SIDED|95.0|-0.392|0.25||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.250|-0.392|0.665
73898043|NCT02880956|147328873|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898044|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.162||0.059|TWO_SIDED|95.0|-0.625|0.012||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.012|-0.625|0.059
73898045|NCT02880956|147328873|SUPERIORITY||Effect size/pooled SD|0.28|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898046|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.164||0.663|TWO_SIDED|95.0|-0.394|0.251||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.251|-0.394|0.663
73898047|NCT02880956|147328873|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898048|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.193||0.866|TWO_SIDED|95.0|-0.413|0.348||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.348|-0.413|0.866
73898049|NCT02880956|147328873|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898050|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.471|TWO_SIDED|95.0|-0.514|0.238||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.238|-0.514|0.471
73898051|NCT02880956|147328873|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898052|NCT02880956|147328873|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.198||0.604|TWO_SIDED|95.0|-0.493|0.287||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.287|-0.493|0.604
73898053|NCT02880956|147328873|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898054|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.069||0.325|TWO_SIDED|95.0|-0.067|0.202||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.202|-0.067|0.325
73898055|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898056|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.067||0.51|TWO_SIDED|95.0|-0.177|0.088||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.088|-0.177|0.510
73898057|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898058|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.069||0.601|TWO_SIDED|95.0|-0.1|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.172|-0.100|0.601
73898059|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898060|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.157|0.119||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.119|-0.157|0.783
73898061|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898062|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.068||0.646|TWO_SIDED|95.0|-0.165|0.103||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.103|-0.165|0.646
73898063|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898064|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.209|TWO_SIDED|95.0|-0.226|0.05||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.050|-0.226|0.209
73898065|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898066|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.091||0.454|TWO_SIDED|95.0|-0.246|0.11||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.110|-0.246|0.454
73898067|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898068|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.089||0.141|TWO_SIDED|95.0|-0.306|0.043||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.043|-0.306|0.141
73898069|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898070|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.107|TWO_SIDED|95.0|-0.323|0.031||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.031|-0.323|0.107
73898071|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|0.24|STANDARD_DEVIATION|0.59|||TWO_SIDED|||||||||Week 72||||
73898072|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.961|TWO_SIDED|95.0|-0.243|0.232||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.232|-0.243|0.961
73898073|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898074|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.118||0.618|TWO_SIDED|95.0|-0.29|0.173||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.173|-0.290|0.618
73898075|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898076|NCT02880956|147328874|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.121||0.227|TWO_SIDED|95.0|-0.385|0.092||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.092|-0.385|0.227
73898077|NCT02880956|147328874|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.79|||TWO_SIDED|||||||||Week 96||||
73898078|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.18||0.056|TWO_SIDED|95.0|-0.009|0.697||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.697|-0.009|0.056
73898079|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|-0.23|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898080|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.177||0.997|TWO_SIDED|95.0|-0.348|0.349||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.349|-0.348|0.997
73898081|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.34|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898082|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|0.41|STANDARD_ERROR_OF_MEAN|0.182||0.023|TWO_SIDED|95.0|0.056|0.772||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.772|0.056|0.023
73898083|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|-0.3|STANDARD_DEVIATION|1.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898084|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.212||0.502|TWO_SIDED|95.0|-0.274|0.558||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.558|-0.274|0.502
74020480|NCT01763164|147593347|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.499|TWO_SIDED|95.0|0.75|1.33|||Log Rank|||Hazard ratio was obtained from the stratified unadjusted Cox model. P-value was obtained from the one-sided stratified log rank test.||1.33|0.75|0.499
73898085|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|1.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898086|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.206||0.379|TWO_SIDED|95.0|-0.587|0.224||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.224|-0.587|0.379
73898087|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898088|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.212||0.916|TWO_SIDED|95.0|-0.439|0.394||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.394|-0.439|0.916
73898089|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898090|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.238||0.487|TWO_SIDED|95.0|-0.633|0.302||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.302|-0.633|0.487
73898091|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898092|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.235||0.963|TWO_SIDED|95.0|-0.451|0.473||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.473|-0.451|0.963
73898093|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898094|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.238||0.856|TWO_SIDED|95.0|-0.424|0.51||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.510|-0.424|0.856
73898095|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898096|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|0.2|STANDARD_ERROR_OF_MEAN|0.277||0.463|TWO_SIDED|95.0|-0.341|0.748||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.748|-0.341|0.463
73898097|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|1.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898098|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.273||0.943|TWO_SIDED|95.0|-0.518|0.557||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.557|-0.518|0.943
73898099|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898100|NCT02880956|147328875|SUPERIORITY||LS Mean of Difference|0.74|STANDARD_ERROR_OF_MEAN|0.281||0.009|TWO_SIDED|95.0|0.191|1.295||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||1.295|0.191|0.009
73898101|NCT02880956|147328875|SUPERIORITY||Effect size/pooled SD|-0.38|STANDARD_DEVIATION|1.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898102|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.138||0.325|TWO_SIDED|95.0|-0.408|0.136||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.136|-0.408|0.325
73898103|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|1.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898104|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.137||0.966|TWO_SIDED|95.0|-0.274|0.263||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.263|-0.274|0.966
73958985|NCT01212757|147453604|SUPERIORITY||Adjusted Difference|1.3||||0.8462|TWO_SIDED|95.0|-12.1|14.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.|||14.7|-12.1|0.8462
73958986|NCT01212757|147453605|SUPERIORITY||Adjusted Difference|2.8||||0.7337|TWO_SIDED|95.0|-13.3|18.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.9|-13.3|0.7337
73958987|NCT01212757|147453605|SUPERIORITY||Adjusted Difference|3.3||||0.6881|TWO_SIDED|95.0|-12.7|19.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.3|-12.7|0.6881
74020481|NCT01763164|147593348|SUPERIORITY|||||||0.015|||||||Cochran-Mantel-Haenszel|||Confirmed ORR: The p-value (2-sided) was computed from stratified Cochran-Mantel-Haenszel chi-square test statistic.||||0.015
74020482|NCT01763164|147593348|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||Confirmed ORR + Unconfirmed ORR: The p-value (2-sided) was computed from stratified Cochran-Mantel-Haenszel chi-square test statistic.||||0.002
74020483|NCT01763164|147593361|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.96|2.13|||Log Rank|||||2.13|0.96|
74020484|NCT01763164|147593364|SUPERIORITY||Hazard Ratio (HR)|2.2||||0.995|TWO_SIDED|95.0|1.19|4.06|||Log Rank|||Log-rank test and Cox PH model were stratified by American joint committee on cancer stage, prior line immunotherapy and ECOG performance status. P-value was one tailed and was based on the log-rank score test. Hazard ratio and 95% CI was based on a Wald test from Cox model.||4.06|1.19|0.995
74020485|NCT04666038|147593411|SUPERIORITY||Hazard Ratio (HR)|0.536||||0.0002|TWO_SIDED|95.0|0.385|0.746||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The Hazard Ratio (HR) \& 95% confidence interval (CI) were estimated from a stratified Cox proportional hazards model.|||0.746|0.385|0.0002
74020486|NCT04666038|147593412|SUPERIORITY||Hazard Ratio (HR)|0.475|||<|0.0001|TWO_SIDED|95.0|0.338|0.669||The 2-sided nominal p-value was calculated based on a stratified log-rank test|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.669|0.338|<0.0001
74020487|NCT04666038|147593413|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7202|TWO_SIDED|95.0|0.679|1.749||The 2-sided p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||1.749|0.679|0.7202
74020488|NCT04666038|147593414|SUPERIORITY||Hazard Ratio (HR)|0.365|||<|0.0001|TWO_SIDED|95.0|0.254|0.524||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.524|0.254|<0.0001
74020489|NCT04666038|147593415|SUPERIORITY||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.28|0.534||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.534|0.280|<0.0001
74020490|NCT03400800|147593419|SUPERIORITY||Mean Difference (Final Values)|-53.5|||<|0.0001|TWO_SIDED|95.0|-56.66|-50.35||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-50.35|-56.66|<0.0001
74020491|NCT03400800|147593420|SUPERIORITY||Mean Difference (Final Values)|-49.17|||<|0.0001|TWO_SIDED|95.0|-51.57|-46.77||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-46.77|-51.57|<0.0001
74020492|NCT03400800|147593421|SUPERIORITY||Median Difference (Final Values)|-51.87|||<|0.0001|TWO_SIDED|95.0|-55.01|-48.72||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-48.72|-55.01|<.0001
74020493|NCT03400800|147593422|SUPERIORITY||Mean Difference (Final Values)|-48.94|||<|0.0001|TWO_SIDED|95.0|-51.39|-46.48||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-46.48|-51.39|<0.0001
74020494|NCT03400800|147593423|SUPERIORITY||Mean Difference (Final Values)|-79.27|||<|0.0001|TWO_SIDED|95.0|-81.97|-76.57||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-76.57|-81.97|<0.0001
74020495|NCT03400800|147593424|SUPERIORITY||Mean Difference (Final Values)|-29.79|||<|0.0001|TWO_SIDED|95.0|-31.78|-27.81||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-27.81|-31.78|<0.0001
74020496|NCT03400800|147593425|SUPERIORITY||Mean Difference (Final Values)|-38.94|||<|0.0001|TWO_SIDED|95.0|-41.21|-36.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-36.67|-41.21|<0.0001
74020497|NCT03400800|147593426|SUPERIORITY||Mean Difference (Final Values)|-43.32|||<|0.0001|TWO_SIDED|95.0|-46.04|-40.6||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-40.60|-46.04|<0.0001
73898105|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74020498|NCT01512264|147593428|OTHER|||||||0.006|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.58.||||0.006
74020499|NCT01512264|147593428|OTHER|||||||0.015|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.27.||||0.015
74020500|NCT01512264|147593428|OTHER|||||||0.203|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.203
74020501|NCT01512264|147593428|OTHER|||||||0.01|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.63.||||0.010
74020502|NCT01512264|147593429|OTHER|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.410
73958988|NCT01212757|147453606|SUPERIORITY||Adjusted Difference|17.5||||0.0014|TWO_SIDED|95.0|7.0|27.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||27.9|7.0|0.0014
73958989|NCT01212757|147453606|SUPERIORITY||Adjusted Difference|22.1||||0.0001|TWO_SIDED|95.0|11.7|32.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||32.5|11.7|0.0001
73958990|NCT01212757|147453607|SUPERIORITY||Adjusted Difference|6.6||||0.3376|TWO_SIDED|95.0|-6.8|20.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||20.0|-6.8|0.3376
73958991|NCT01212757|147453607|SUPERIORITY||Adjusted Difference|6.1||||0.3756|TWO_SIDED|95.0|-7.2|19.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.4|-7.2|0.3756
73958992|NCT01212757|147453608|SUPERIORITY||Adjusted Difference|6.8||||0.3959|TWO_SIDED|95.0|-8.7|22.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.2|-8.7|0.3959
73958993|NCT01212757|147453608|SUPERIORITY||Adjusted Difference|6.8||||0.3941|TWO_SIDED|95.0|-8.7|22.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.4|-8.7|0.3941
73958994|NCT01212757|147453609|SUPERIORITY||Adjusted Difference|12.1||||0.0142|TWO_SIDED|95.0|2.6|21.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.7|2.6|0.0142
73958995|NCT01212757|147453609|SUPERIORITY||Adjusted Difference|20.5||||0.0001|TWO_SIDED|95.0|10.8|30.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||30.3|10.8|0.0001
73958996|NCT01212757|147453610|SUPERIORITY||Adjusted Difference|5.6||||0.0589|TWO_SIDED|95.0|-0.2|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||11.3|-0.2|0.0589
73958997|NCT01212757|147453610|SUPERIORITY||Adjusted Difference|9.8||||0.0034|TWO_SIDED|95.0|3.4|16.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.1|3.4|0.0034
73958998|NCT01212757|147453611|SUPERIORITY||Adjusted Difference|0.6||||0.562|TWO_SIDED|95.0|-1.5|2.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||2.7|-1.5|0.5620
73958999|NCT01212757|147453611|SUPERIORITY||Adjusted Difference|3.1||||0.057|TWO_SIDED|95.0|0.0|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.2|-0.0|0.0570
73959000|NCT01212757|147453612|SUPERIORITY||Adjusted Difference|3.1||||0.3629|TWO_SIDED|95.0|-3.5|9.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||9.6|-3.5|0.3629
73959001|NCT01212757|147453612|SUPERIORITY||Adjusted Difference|5.4||||0.1323|TWO_SIDED|95.0|-1.5|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||12.3|-1.5|0.1323
73970936|NCT03899259|147481959|SUPERIORITY||Odds Ratio (OR)|7.86|||<|0.001|TWO_SIDED|95.0|2.79|22.17|||Regression, Logistic|||||22.17|2.79|<0.001
73970937|NCT03899259|147481959|SUPERIORITY||Odds Ratio (OR)|19.72|||<|0.001|TWO_SIDED|95.0|7.3|53.3|||Regression, Logistic|||||53.30|7.30|<0.001
73970938|NCT03899259|147481960|SUPERIORITY||Mean Difference (Final Values)|-25.25|STANDARD_ERROR_OF_MEAN|3.834|<|0.001|TWO_SIDED|95.0|-32.78|-17.72|||ANCOVA|||||-17.72|-32.78|<0.001
73970939|NCT03899259|147481960|SUPERIORITY||Mean Difference (Final Values)|-44.49|STANDARD_ERROR_OF_MEAN|3.482|<|0.001|TWO_SIDED|95.0|-51.33|-37.65|||ANCOVA|||||-37.65|-51.33|<0.001
73970940|NCT03899259|147481961|SUPERIORITY||Odds Ratio (OR)|4.63||||0.005|TWO_SIDED|95.0|1.58|13.6|||Regression, Logistic|||||13.60|1.58|0.005
73970941|NCT03899259|147481961|SUPERIORITY||Odds Ratio (OR)|12.94|||<|0.001|TWO_SIDED|95.0|4.72|35.44|||Regression, Logistic|||||35.44|4.72|<0.001
73970942|NCT03899259|147481962|SUPERIORITY||Odds Ratio (OR)|4.36||||0.001|TWO_SIDED|95.0|1.77|10.74|||Regression, Logistic|||||10.74|1.77|0.001
73959002|NCT01212757|147453613|SUPERIORITY||Adjusted Difference|-0.6||||0.7273|TWO_SIDED|95.0|-4.3|3.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||3.0|-4.3|0.7273
73959003|NCT01212757|147453613|SUPERIORITY||Adjusted Difference|2.4||||0.2929|TWO_SIDED|95.0|-2.0|6.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.8|-2.0|0.2929
73959004|NCT01212757|147453614|SUPERIORITY||Adjusted Difference|-2.2||||0.7023|TWO_SIDED|95.0|-13.5|9.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||9.1|-13.5|0.7023
73959005|NCT01212757|147453614|SUPERIORITY||Adjusted Difference|5.9||||0.3305|TWO_SIDED|95.0|-5.9|17.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.7|-5.9|0.3305
73959006|NCT01212757|147453615|SUPERIORITY||Adjusted Difference|0.3||||0.9698|TWO_SIDED|95.0|-16.0|16.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.6|-16.0|0.9698
73959007|NCT01212757|147453615|SUPERIORITY||Adjusted Difference|1.9||||0.8205|TWO_SIDED|95.0|-14.3|18.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.1|-14.3|0.8205
73959008|NCT01212757|147453616|SUPERIORITY||Adjusted Difference|-1.2||||0.8424|TWO_SIDED|95.0|-12.7|10.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||10.3|-12.7|0.8424
73959009|NCT01212757|147453616|SUPERIORITY||Adjusted Difference|5.9||||0.3395|TWO_SIDED|95.0|-6.0|17.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.8|-6.0|0.3395
73959010|NCT01212757|147453617|SUPERIORITY||Adjusted Difference|5.9||||0.4811|TWO_SIDED|95.0|-10.3|22.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.1|-10.3|0.4811
73959011|NCT01212757|147453617|SUPERIORITY||Adjusted Difference|3.3||||0.6965|TWO_SIDED|95.0|-13.3|19.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.5|-13.3|0.6965
73959012|NCT01606124|147453651|SUPERIORITY|||||||0.5631|||||||Wilcoxon (Mann-Whitney)|||||||0.5631
73898106|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.695|TWO_SIDED|95.0|-0.33|0.22||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.220|-0.330|0.695
73959013|NCT01606124|147453652|SUPERIORITY|||||||0.1439|||||||Wilcoxon (Mann-Whitney)|||||||0.1439
73959014|NCT00955825|147453671|SUPERIORITY_OR_OTHER||LS Mean difference vs. Placebo|-0.126||||0.0003||95.0|-0.194|-0.058|||ANCOVA||Relative LS Means difference (%) = - 28.24|||-0.058|-0.194|0.0003
73959015|NCT00738699|147453679|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13||||0.836|TWO_SIDED|95.0|0.88|1.46||One-sided log rank test stratified by route of administration for primary chemotherapy (intraperitoneal vs intravenous) and geographic region (North America, Europe, and other participating countries).|Log Rank||Stratified as described above.|||1.46|0.88|0.8360
73959016|NCT00738699|147453680|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11||||0.7568|TWO_SIDED|95.0|0.83|1.48||One-sided log rank test stratified by route of administration for primary chemotherapy and geographic region.|Log Rank||Stratified as described above|||1.48|0.83|0.7568
73959017|NCT00738699|147453681|SUPERIORITY_OR_OTHER||Difference|-7.4||||0.0399|TWO_SIDED|95.0|-14.1|-0.7||Compared the ratio of complete or partial responders in the two arms. Stratified by route of administration for first line therapy and geographic region as specified at baseline.|Cochran-Mantel-Haenszel||(FAR + Paclitaxel) minus (Placebo + Paclitaxel). Confidence interval based on a normal approximation to the binomial distribution.|||-0.7|-14.1|0.0399
73959018|NCT00549848|147453685|SUPERIORITY|||||||0.778|||||||Cochran-Mantel-Haenszel|||||||0.778
73959019|NCT03262935|147453705|SUPERIORITY||Hazard Ratio (HR)|0.6401|||=|0.002|TWO_SIDED|95.0|0.4885|0.8389||P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the hazard ratio of PFS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \>2), and prior treatment with pertuzumab (yes, no).||0.8389|0.4885|=0.002
73970943|NCT03899259|147481962|SUPERIORITY||Odds Ratio (OR)|13.37|||<|0.001|TWO_SIDED|95.0|5.75|31.1|||Regression, Logistic|||||31.10|5.75|<0.001
74080983|NCT02997176|147713967|OTHER|Bioequivalence|Percent Ratio of Geometric Means|115.32|||||TWO_SIDED|90.0|77.95|170.6||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||170.6|77.95|
73959020|NCT03262935|147453706|SUPERIORITY||Hazard Ratio (HR)|0.868|||=|0.236|TWO_SIDED|95.0|0.676|1.1145||P-value from stratified log-rank test for Kaplan-Meier estimate of median OS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the hazard ratio of OS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \>2), and prior treatment with pertuzumab (yes, no).||1.1145|0.676|=0.236
73959021|NCT03262935|147453707|SUPERIORITY||||||=|0.732||||||P-value from Cochran-Mantel-Haenszel test including the randomization stratification factors.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel test (strata based on the baseline stratification factors) was used to compare the two treatment groups with respect to the ORR at two-sided 5% level of significance.||||=0.732
73959022|NCT03262935|147453708|SUPERIORITY||Hazard Ratio (HR)|0.5995|||<|0.001|TWO_SIDED|95.0|0.4666|0.7703||P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the HR of PFS, along with the 95% CI. The treatment groups were compared using the 2-sided stratified log-rank test.||0.7703|0.4666|<0.001
73959023|NCT03262935|147453709|SUPERIORITY|||||||0.473|||||||MMRM|||The change from baseline in the global health status/QoL scale transformed score was analyzed using a mixed model repeated measurement (MMRM) approach.||||0.473
73959024|NCT01811706|147453710|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of T25FW between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
73959025|NCT01811706|147453711|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of SARA score between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
73959026|NCT01811706|147453712|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of Stride Length on BAG between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
73959027|NCT00355914|147453812|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||compared baseline, 3, 6, 12, 18, and 24 months between groups||||>0.05
73970944|NCT03899259|147481964|SUPERIORITY||Odds Ratio (OR)|2.56||||0.076|TWO_SIDED|95.0|0.91|7.24|||Regression, Logistic|||||7.24|0.91|0.076
73970945|NCT03899259|147481964|SUPERIORITY||Odds Ratio (OR)|10.3|||<|0.001|TWO_SIDED|95.0|4.12|25.77|||Regression, Logistic|||||25.77|4.12|<0.001
73970946|NCT03899259|147481965|SUPERIORITY||Odds Ratio (OR)|1.88||||0.26|TWO_SIDED|95.0|0.63|5.62|||Regression, Logistic|||||5.62|0.63|0.260
74080984|NCT02997176|147713967|OTHER|Bioequivalence|Percent Ratio of Geometric Means|132.26|||||TWO_SIDED|90.0|81.87|213.67||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||213.67|81.87|
73970947|NCT03899259|147481965|SUPERIORITY||Odds Ratio (OR)|8.1|||<|0.001|TWO_SIDED|95.0|3.18|20.66|||Regression, Logistic|||||20.66|3.18|<0.001
73970948|NCT03899259|147481966|SUPERIORITY||Odds Ratio (OR)|3.43||||0.017|TWO_SIDED|95.0|1.25|9.4|||Regression, Logistic|||||9.40|1.25|0.017
73970949|NCT03899259|147481966|SUPERIORITY||Odds Ratio (OR)|10.85|||<|0.001|TWO_SIDED|95.0|4.32|27.25|||Regression, Logistic|||||27.25|4.32|<0.001
73970950|NCT03899259|147481967|SUPERIORITY||Odds Ratio (OR)|14.63||||0.002|TWO_SIDED|95.0|2.73|78.42|||Regression, Logistic|||||78.42|2.73|0.002
73970951|NCT03899259|147481967|SUPERIORITY||Odds Ratio (OR)|30.37|||<|0.001|TWO_SIDED|95.0|5.93|99.99|||Regression, Logistic|||||99.99|5.93|<0.001
73970952|NCT03899259|147481968|SUPERIORITY||Mean Difference (Final Values)|-3.02|STANDARD_ERROR_OF_MEAN|1.981||0.129|TWO_SIDED|95.0|-6.91|0.88|||ANCOVA|||||0.88|-6.91|0.129
73970953|NCT03899259|147481968|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|1.799||0.02|TWO_SIDED|95.0|-7.75|-0.68|||ANCOVA|||||-0.68|-7.75|0.020
73970954|NCT03899259|147481969|SUPERIORITY||Mean Difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|3.017||0.026|TWO_SIDED|95.0|-12.68|-0.82|||ANCOVA|||||-0.82|-12.68|0.026
73970955|NCT03899259|147481969|SUPERIORITY||Mean Difference (Final Values)|-13.42|STANDARD_ERROR_OF_MEAN|2.737|<|0.001|TWO_SIDED|95.0|-18.8|-8.04|||ANCOVA|||||-8.04|-18.80|<0.001
73970956|NCT03899259|147481970|SUPERIORITY||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|2.68||0.103|TWO_SIDED|95.0|-9.65|0.88|||ANCOVA|||||0.88|-9.65|0.103
73970957|NCT03899259|147481970|SUPERIORITY||Mean Difference (Final Values)|-8.33|STANDARD_ERROR_OF_MEAN|2.429|<|0.001|TWO_SIDED|95.0|-13.1|-3.56|||ANCOVA|||||-3.56|-13.10|<0.001
73970958|NCT03899259|147481971|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.315||0.518|TWO_SIDED|95.0|-0.82|0.42|||ANCOVA|||||0.42|-0.82|0.518
73970959|NCT03899259|147481971|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.286||0.012|TWO_SIDED|95.0|-1.28|-0.16|||ANCOVA|||||-0.16|-1.28|0.012
73970960|NCT03899259|147481972|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.291||0.083|TWO_SIDED|95.0|-1.08|0.07|||ANCOVA|||||0.07|-1.08|0.083
73970961|NCT03899259|147481972|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.264||0.01|TWO_SIDED|95.0|-1.2|-0.16|||ANCOVA|||||-0.16|-1.20|0.010
73970962|NCT05139810|147481973|SUPERIORITY||IC HAE attack rate ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.107|0.351|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 1 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used to account for potential over dispersion.||0.351|0.107|<0.001
73970963|NCT05139810|147481973|SUPERIORITY||IC HAE attack rate ratio|0.45|||=|0.004|TWO_SIDED|95.0|0.261|0.777|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 1 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential overdispersion.||0.777|0.261|=0.004
74020503|NCT01512264|147593429|OTHER|||||||0.618|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.57.||||0.618
74020504|NCT01512264|147593429|OTHER|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 1.31.||||1.000
74020505|NCT01512264|147593429|OTHER|||||||0.019|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 4.35.||||0.019
74020506|NCT01512264|147593431|OTHER|||||||0.118|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.69.||||0.118
74020507|NCT01512264|147593431|OTHER|||||||0.482|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.||||0.482
74020508|NCT01512264|147593431|OTHER|||||||0.368|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.37.||||0.368
74020509|NCT01512264|147593431|OTHER|||||||0.147|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.70.||||0.147
74020510|NCT01512264|147593432|OTHER|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.410
74020511|NCT01512264|147593432|OTHER|||||||0.695|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.25.||||0.695
74020512|NCT01512264|147593432|OTHER|||||||0.175|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.25.||||0.175
74020513|NCT01512264|147593432|OTHER|||||||0.518|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.60.||||0.518
74020514|NCT01512264|147593434|OTHER|||||||0.109|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.71.||||0.109
74020515|NCT01512264|147593434|OTHER|||||||0.485|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.||||0.485
74020516|NCT01512264|147593434|OTHER|||||||0.864|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.07.||||0.864
74020517|NCT01512264|147593434|OTHER|||||||0.341|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.43.||||0.341
74020518|NCT01512264|147593435|OTHER|||||||0.899|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.12.||||0.899
74020519|NCT01512264|147593435|OTHER|||||||0.519|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.19.||||0.519
74020520|NCT01512264|147593435|OTHER|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.09.||||1.000
74020521|NCT01512264|147593435|OTHER|||||||0.14|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.84.||||0.140
74020522|NCT01512264|147593437|OTHER|||||||0.52|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.24.||||0.520
74020523|NCT01512264|147593437|OTHER|||||||0.8|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.97.||||0.800
74020524|NCT01512264|147593437|OTHER|||||||0.148|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.68.||||0.148
74020525|NCT01512264|147593437|OTHER|||||||0.787|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.67.||||0.787
74020526|NCT01512264|147593438|OTHER|||||||0.239|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.12.||||0.239
74020527|NCT01512264|147593438|OTHER|||||||0.212|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 2.71.||||0.212
74020528|NCT01512264|147593438|OTHER|||||||0.12|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.10.||||0.120
74020529|NCT01512264|147593438|OTHER|||||||0.263|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.14.||||0.263
74020530|NCT00996203|147593459|SUPERIORITY_OR_OTHER||||||<|0.001||||||EQ-5D scores at Baseline Versus Week 24|t-test, 2 sided|||||||<0.001
74020531|NCT00996203|147593462|SUPERIORITY_OR_OTHER||||||<|0.001||||||General health at baseline Versus Week 24|t-test, 2 sided|||||||<0.001
74020532|NCT00996203|147593464|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline Versus Week 24 DAS28 scores|t-test, 2 sided|||||||<0.001
74020533|NCT00996203|147593466|SUPERIORITY_OR_OTHER||||||<|0.001||||||Mean HAQ scores at Baseline Versus Week 24|t-test, 2 sided|||||||<0.001
74020534|NCT03094195|147593555|SUPERIORITY||least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.56||0.689|TWO_SIDED|95.0|-1.3|0.9|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689||||0.9|-1.3|0.689
74020535|NCT03094195|147593555|SUPERIORITY||LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.54||0.35|TWO_SIDED|95.0|-1.6|0.6|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689||||0.6|-1.6|0.350
74020536|NCT03094195|147593559|SUPERIORITY||Odds Ratio (OR)|0.9||||0.908|TWO_SIDED|95.0|0.3|3.2|||Regression, Logistic|||||3.2|0.3|0.908
74020537|NCT03094195|147593559|SUPERIORITY||Odds Ratio (OR)|1.4||||0.609|TWO_SIDED|95.0|0.4|4.5|||Regression, Logistic|||||4.5|0.4|0.609
74020538|NCT03094195|147593560|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8|TWO_SIDED|95.0|0.3|3.2|||Regression, Logistic|||||3.2|0.3|0.800
74080985|NCT02997176|147713968|OTHER|Bioequivalence|Percent Ratio of Geometric Means|124.4|||||TWO_SIDED|90.0|85.19|181.66||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||181.66|85.19|
74080986|NCT02997176|147713968|OTHER|Bioequivalence|Percent Ratio of Geometric Means|113.42|||||TWO_SIDED|90.0|73.9|174.07||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||174.07|73.90|
74020539|NCT03094195|147593560|SUPERIORITY||Odds Ratio (OR)|1.4||||0.653|TWO_SIDED|95.0|0.4|4.5|||Regression, Logistic|||||4.5|0.4|0.653
74020540|NCT03094195|147593562|SUPERIORITY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.49||0.225|TWO_SIDED|95.0|-0.4|1.6|||ANCOVA|||||1.6|-0.4|0.225
74020541|NCT03094195|147593562|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.53||0.914|TWO_SIDED|95.0|-1.0|1.1|||ANCOVA|||||1.1|-1.0|0.914
74020542|NCT02238847|147593566|NON_INFERIORITY|The prespecified non-inferiority margin was set at 20%. This was chosen to support a practical study size while still able to identify major differences if this were the case.|||||<|0.01||||||Reported p-value of \<0.01 is calculated p-value. (p\<0.05 was considered significant)|Exact Non-inferiority|||||||<0.01
74020543|NCT02238847|147593567|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
74020544|NCT01988090|147593576|SUPERIORITY|||||||0.7635|||||||Chi-squared|||||||0.7635
74020545|NCT01988090|147593578|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74020546|NCT01439945|147593595|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.||||||0.13
74020547|NCT01439945|147593595|SUPERIORITY_OR_OTHER|||||||0.67|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.||||||0.67
74020548|NCT01439945|147593596|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|Weekly number of hot flashes were treated as a repeated measure for each patient.||||||0.25
74020549|NCT01439945|147593596|SUPERIORITY_OR_OTHER|||||||0.55||||||Weekly number of hot flashes were treated as a repeated measure for each patient.|ANOVA|||||||0.55
74020550|NCT01439945|147593599|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
74020551|NCT01439945|147593600|SUPERIORITY_OR_OTHER|||||||0.47|||||||Kruskal-Wallis|||||||0.47
74020552|NCT01439945|147593600|SUPERIORITY_OR_OTHER|||||||0.09|||||||Kruskal-Wallis|||||||0.09
74020553|NCT02107703|147593610|OTHER||Hazard Ratio (HR)|0.553|||<|1e-07|TWO_SIDED|95.0|0.449|0.681||This is two sided P value and it is statistically significant.|Log Rank|Log rank test is stratified by endocrine sensitivity and natural of disease by interactive web response system (IWRS).||The final analysis was planned at 378 PFS events, which would provide approximately 90% power assuming a hazard ratio (HR) of 0.703 at a one-sided α of 0.025.||0.681|0.449|<0.0000001
74020554|NCT03990870|147593630|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
74020555|NCT03990870|147593633|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
74020556|NCT03990870|147593635|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
74020557|NCT01169779|147593636|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.099||0.0004|TWO_SIDED|95.0|-0.551|-0.162||Statistical testing:2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), sulfonylurea use (Yes,No), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change in HbA1c at Week 24 between lixisenatide arm and placebo arm, 190 patients per group would provide a power of 96% assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.||-0.162|-0.551|0.0004
74020558|NCT01989221|147593646|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_DEVIATION|0.12|<|0.01|TWO_SIDED|95.0||||Threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean GCSI-DD scores during one week at baseline were compared to mean GCSI-DD scores during the second week of Sancuso treatment.|||||<0.01
74020559|NCT01989221|147593647|OTHER||Mean Difference (Final Values)|1.01|STANDARD_DEVIATION|0.27|<|0.01|TWO_SIDED|95.0||||Threshold for statistical significance was p \< 0.05|t-test, 2 sided||Mean nausea and vomiting symptom scores during one week at baseline were compared to mean symptom scores during the second week of Sancuso treatment.|||||<0.01
74020560|NCT01279057|147593648|EQUIVALENCE|If the 90% confidence intervals were contained within the interval 80.0% to 125.0%, then the two products were considered to be therapeutically equivalent.|Ratio Test/Ref. Least Squares (LS) Means|104.085|||||TWO_SIDED|90.0|87.421|124.21||||||||124.210|87.421|
74020561|NCT01279057|147593649|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74020562|NCT01279057|147593649|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
74020563|NCT01279057|147593650|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|106.635|||||TWO_SIDED|90.0|89.256|127.79||||||||127.790|89.256|
74020564|NCT01279057|147593651|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74020565|NCT01279057|147593651|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74020566|NCT01279057|147593652|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|115.877|||||TWO_SIDED|90.0|94.129|143.949||||||||143.949|94.129|
74020567|NCT01279057|147593653|SUPERIORITY|||||||0.0018|||||||ANCOVA|||||||0.0018
74020568|NCT01279057|147593653|SUPERIORITY|||||||0.0441|||||||ANCOVA|||||||0.0441
74020569|NCT01279057|147593654|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|117.712|||||TWO_SIDED|90.0|95.41|146.583||||||||146.583|95.410|
74020570|NCT01279057|147593655|SUPERIORITY|||||||0.0018|||||||ANCOVA|||||||0.0018
74020571|NCT01279057|147593655|SUPERIORITY|||||||0.0451|||||||ANCOVA|||||||0.0451
74020572|NCT00542620|147593671|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\>0.25% against HA: D=\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Median Difference (Final Values)|-0.691||||0.001||95.0|-1.049|-0.334||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated|ANCOVA|Baseline HbA1c as covariate||||-0.334|-1.049|0.001
74020573|NCT00542620|147593672|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\>0.25% against HA: D=\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Mean Difference (Final Values)|-0.594||||0.003||95.0|-0.97|-0.219||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated.|ANCOVA|Baseline HbA1c as covariate.||||-0.219|-0.970|0.003
74020574|NCT00542620|147593673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.35|STANDARD_ERROR_OF_MEAN|14.59||0.573||95.0|-38.77|22.08|||ANCOVA|With adjustment on baseline fructosamine and the change in insulin administration mode||||22.08|-38.77|0.573
73836821|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.4|||||TWO_SIDED|95.0|0.17|0.92||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.92|0.17|
74020575|NCT00542620|147593674|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANCOVA|With adjustment on baseline value||||||0.063
74020576|NCT00542620|147593675|SUPERIORITY_OR_OTHER|||||||0.389|||||||ANCOVA|With adjustment on baseline value||||||0.389
74020577|NCT00542620|147593676|SUPERIORITY_OR_OTHER|||||||0.856|||||||ANCOVA|With adjustment on baseline value||||||0.856
74020578|NCT00542620|147593677|SUPERIORITY_OR_OTHER|||||||0.917|||||||ANCOVA|With adjustment on baseline value||||||0.917
74020579|NCT00542620|147593678|SUPERIORITY_OR_OTHER|||||||0.209|||||||ANCOVA|With adjustment on baseline value||||||0.209
74020580|NCT00542620|147593679|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANCOVA|With adjustment on baseline value||||||0.220
74020581|NCT00542620|147593680|SUPERIORITY_OR_OTHER|||||||0.234|||||||ANCOVA|With adjustment for baseline value||||||0.234
74020582|NCT00542620|147593681|SUPERIORITY_OR_OTHER|||||||0.534|||||||ANCOVA|With adjustment on baseline value||||||0.534
74020583|NCT00542620|147593682|SUPERIORITY_OR_OTHER|||||||0.722|||||||ANCOVA|With adjustment on baseline value||||||0.722
74020584|NCT00542620|147593683|SUPERIORITY_OR_OTHER|||||||0.727|||||||ANCOVA|With adjustment on baseline value||||||0.727
74020585|NCT00542620|147593684|SUPERIORITY_OR_OTHER|||||||0.411|||||||ANCOVA|With adjustment on baseline value||||||0.411
74020586|NCT00542620|147593685|SUPERIORITY_OR_OTHER|||||||0.471|||||||ANCOVA|With adjustment on baseline value||||||0.471
74020587|NCT00542620|147593688|SUPERIORITY_OR_OTHER|||||||0.127|||||||ANCOVA|With adjustment on baseline value||||||0.127
74020588|NCT00542620|147593689|SUPERIORITY_OR_OTHER|||||||0.1|||||||ANCOVA|With adjustment on baseline value||||||0.1
74020589|NCT00542620|147593690|SUPERIORITY_OR_OTHER|||||||0.166|||||||ANCOVA|With adjustment on baseline value||||||0.166
74020590|NCT00542620|147593691|SUPERIORITY_OR_OTHER|||||||0.023|||||||ANCOVA|With adjustment on baseline value||||||0.023
74020591|NCT00542620|147593692|SUPERIORITY_OR_OTHER|||||||0.439|||||||ANCOVA|With adjustment on baseline value||||||0.439
74020592|NCT00542620|147593693|SUPERIORITY_OR_OTHER|||||||0.202|||||||ANCOVA|With adjustment on baseline value||||||0.202
74020593|NCT00542620|147593694|SUPERIORITY_OR_OTHER|||||||0.665|||||||ANCOVA|With adjustment on baseline value||||||0.665
74020594|NCT00849017|147593702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.58|||ANCOVA|||||-0.58|-1.11|<0.0001
74020595|NCT00849017|147593702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.77|||ANCOVA|||||-0.77|-1.31|<0.0001
74020596|NCT01577238|147593735|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74020597|NCT00110994|147593755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.068|TWO_SIDED|95.0|0.428|1.034|||log rank test|||||1.034|0.428|0.068
74020598|NCT00110994|147593756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.973|TWO_SIDED|95.0|0.627|1.57|||log rank test|||||1.570|0.627|0.973
74020599|NCT00110994|147593758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.619||||0.039|TWO_SIDED|95.0|0.391|0.98|||log rank test|||||0.980|0.391|0.039
74020600|NCT00110994|147593759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.427||||0.194|TWO_SIDED|95.0|0.114|1.601|||log rank test|||||1.601|0.114|0.194
74020601|NCT00110994|147593761|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||t-test, 2 sided|||||||0.908
74020602|NCT00110994|147593762|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||t-test, 2 sided|||||||0.890
74020603|NCT00110994|147593763|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||t-test, 2 sided|||||||0.201
74020604|NCT00110994|147593764|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||t-test, 2 sided|||||||0.168
74020605|NCT01570244|147593799|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|140.96|STANDARD_DEVIATION|8.1|||TWO_SIDED|90.0|133.84|148.47|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||148.47|133.84|
74020606|NCT01570244|147593800|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Odds Ratio (OR)|114.82|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|105.49|124.97|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||124.97|105.49|
74020607|NCT01570244|147593801|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|171.37|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|160.2|183.33|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||183.33|160.20|
74020608|NCT01570244|147593804|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric mean ratio|140.53|STANDARD_DEVIATION|4.6|||TWO_SIDED|90.0|136.4|144.78|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||144.78|136.40|
74020609|NCT01570244|147593805|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.28|STANDARD_DEVIATION|6.1|||TWO_SIDED|90.0|110.81|119.92|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||119.92|110.81|
74020610|NCT01570244|147593806|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|153.85|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|145.99|162.14|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||162.14|145.99|
74020611|NCT00531960|147593814|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.806|TWO_SIDED|95.0|0.7|1.59|||Log Rank|||||1.59|0.70|0.8060
74020612|NCT00531960|147593816|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.4063|TWO_SIDED|95.0|0.75|2.05|||Log Rank|||||2.05|0.75|0.4063
74020613|NCT00531960|147593817|SUPERIORITY_OR_OTHER||Difference in Response Rates|-17.28||||0.0444|TWO_SIDED|95.0|-34.8|0.3|||Chi-squared||The 95% CI for the difference of 2 rates was determined by using the Hauck-Anderson method.|||0.3|-34.8|0.0444
74020614|NCT00531960|147593818|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-12.2||||0.0944|TWO_SIDED|95.0|-27.3|2.8|||Chi-squared||The 95% CI for the difference in disease control was determined using the Hauck-Anderson method.|||2.8|-27.3|0.0944
74020615|NCT01879410|147593855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.063|0.139|||ANCOVA||Least squares mean difference=UMEC/VI 62.5/25 mcg minus FSC 250/50 mcg.|||0.139|0.063|<0.001
74020616|NCT01756456|147593869|SUPERIORITY|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 \[Yes/No\]).|Difference in percentage|35.3|||<|0.001|TWO_SIDED|97.06|15.88|54.71|||Chi-squared|||Phase II||54.71|15.88|<0.001
74020617|NCT01756456|147593869|SUPERIORITY|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 \[Yes/No\]).|Difference in percentage|38.4|||=|0.001|TWO_SIDED|97.06|18.96|57.83|||Chi-squared|||||57.83|18.96|=0.001
74020618|NCT01756456|147593870|SUPERIORITY||Difference in percentage|25.8|||=|0.016|TWO_SIDED|97.06|3.66|47.87|||Chi-squared|||||47.87|3.66|=0.016
74020619|NCT01756456|147593870|SUPERIORITY||Difference in percentage|34.7|||=|0.002|TWO_SIDED|97.06|11.91|57.41|||Chi-squared|||||57.41|11.91|=0.002
74020620|NCT01756456|147593871|SUPERIORITY||difference in percentage|2.4|||=|0.818|TWO_SIDED|97.06|-20.3|25.08|||Chi-squared|||At week 6 - reading center||25.08|-20.30|=0.818
74020621|NCT01756456|147593871|SUPERIORITY||difference in percentage|-6.3|||=|0.571|TWO_SIDED|97.06|-30.62|17.96|||Chi-squared|||at week 6 - central reading center||17.96|-30.62|=0.571
74020622|NCT01756456|147593871|SUPERIORITY||Difference in percentage|20.3|||=|0.064|TWO_SIDED|97.06|-3.11|43.79|||Chi-squared|||week 6 - investigator||43.79|-3.11|=0.064
74020623|NCT01756456|147593871|SUPERIORITY||Difference in percentage|23.1|||=|0.041|TWO_SIDED|97.06|-0.89|47.04|||Chi-squared|||week 6 - investigator||47.04|-0.89|=0.041
74020624|NCT01756456|147593871|SUPERIORITY||Difference in percentage|21.9|||=|0.031|TWO_SIDED|97.06|0.07|43.64|||Chi-squared|||week 8 - central reading center||43.64|0.07|=0.031
74020625|NCT01756456|147593871|SUPERIORITY||difference in percentage|26.9|||=|0.008|TWO_SIDED|97.06|5.57|48.28|||Chi-squared|||week 8 - central reading center||48.28|5.57|=0.008
74020626|NCT01756456|147593871|SUPERIORITY||Difference in percentage|26.1|||=|0.011|TWO_SIDED|97.06|4.18|48.01|||Chi-squared|||week 8 - investigator||48.01|4.18|=0.011
74020627|NCT01756456|147593871|SUPERIORITY||Difference in percentage|25.9|||=|0.014|TWO_SIDED|97.06|3.55|48.33|||Chi-squared|||week 8 - investigator||48.33|3.55|=0.014
74020628|NCT01756456|147593872|SUPERIORITY||difference in percentage|13.7|||=|0.065|TWO_SIDED|95.0|-0.19|27.57|||Chi-squared|||week 4||27.57|-0.19|=0.065
74020629|NCT01756456|147593872|SUPERIORITY||difference in percentage|12.4|||=|0.097|TWO_SIDED|95.0|-2.05|26.78|||Chi-squared|||week 4||26.78|-2.05|=0.097
74020630|NCT01756456|147593872|SUPERIORITY||difference in percentage|16.9|||=|0.036|TWO_SIDED|95.0|1.97|31.92|||Chi-squared|||week 6||31.92|1.97|=0.036
74020631|NCT01756456|147593872|SUPERIORITY||difference in percentage|15.6|||=|0.054|TWO_SIDED|95.0|0.04|31.12|||Chi-squared|||week 6||31.12|0.04|=0.054
74020632|NCT01756456|147593872|SUPERIORITY||difference in percentage|17.1|||=|0.043|TWO_SIDED|95.0|1.45|32.72|||Chi-squared|||week 8||32.72|1.45|=0.043
74020633|NCT01756456|147593872|SUPERIORITY||difference in percentage|11.4|||=|0.157|TWO_SIDED|95.0|-4.08|26.93|||Chi-squared|||week 8||26.93|-4.08|=0.157
74020634|NCT01756456|147593873|SUPERIORITY||least square mean difference|8.9|||=|0.022|TWO_SIDED|95.0|1.33|16.5|||ANCOVA|||||16.50|1.33|=0.022
74020635|NCT01756456|147593873|SUPERIORITY||least square mean difference|5.0|||=|0.213|TWO_SIDED|95.0|-2.9|12.88|||ANCOVA|||||12.88|-2.90|=0.213
74020636|NCT01756456|147593874|SUPERIORITY||difference in percentage|5.5|||=|0.592|TWO_SIDED|95.0|-14.53|25.48|||Chi-squared|||week 4||25.48|-14.53|=0.592
74020637|NCT01756456|147593874|SUPERIORITY|week 4|difference in percentage|-2.3|||=|0.835|TWO_SIDED|95.0|-24.01|19.4|||Chi-squared|||||19.40|-24.01|=0.835
74020638|NCT01756456|147593874|SUPERIORITY||difference in percentage|27.7|||=|0.008|TWO_SIDED|95.0|8.1|47.22|||Chi-squared|||week 6||47.22|8.10|=0.008
74020639|NCT01756456|147593874|SUPERIORITY||difference in percentage|12.4|||=|0.282|TWO_SIDED|95.0|-9.91|34.68|||Chi-squared|||week 6||34.68|-9.91|=0.282
74020640|NCT01756456|147593874|SUPERIORITY||difference in percentage|10.2|||=|0.303|TWO_SIDED|95.0|-9.15|29.45|||Chi-squared|||||29.45|-9.15|=0.303
74020641|NCT01756456|147593874|SUPERIORITY||difference in percentage|7.9|||=|0.442|TWO_SIDED|95.0|-12.13|27.92|||Chi-squared|||week 8||27.92|-12.13|=0.442
74020642|NCT01756456|147593875|SUPERIORITY||difference in percentage|-2.6|||=|0.597|TWO_SIDED|95.0|-22.87|17.71|||Chi-squared|||week 4||17.71|-22.87|=0.597
74020643|NCT01756456|147593875|SUPERIORITY||difference in percentage|-2.3|||>|0.999|TWO_SIDED|95.0|-23.26|18.71|||Chi-squared|||week 4||18.71|-23.26|>0.999
74020644|NCT01756456|147593875|SUPERIORITY||difference in percentage|-7.8|||=|0.183|TWO_SIDED|95.0|-28.7|13.76|||Chi-squared|||week 6||13.76|-28.70|=0.183
73836822|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|2.57|||||TWO_SIDED|95.0|1.5|4.39||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.39|1.50|
74020645|NCT01756456|147593875|SUPERIORITY||difference in percentage|-10.0|||=|0.116|TWO_SIDED|95.0|-31.41|11.88|||Chi-squared|||week 6||11.88|-31.41|=0.116
74020646|NCT01756456|147593875|SUPERIORITY||difference in percentage|-10.8|||=|0.134|TWO_SIDED|95.0|-31.3|10.35|||Chi-squared|||week 8||10.35|-31.30|=0.134
74020647|NCT01756456|147593875|SUPERIORITY||difference in percentage|-7.9|||=|0.307|TWO_SIDED|95.0|-29.51|13.52|||Chi-squared|||week 8||13.52|-29.51|=0.307
73836823|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|1.24|||||TWO_SIDED|95.0|0.75|2.05||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.05|0.75|
74020648|NCT01756456|147593877|SUPERIORITY||Odds Ratio (OR)|2.18|||=|0.041|TWO_SIDED|95.0|1.03|4.62|||Chi-squared|||week 4||4.62|1.03|=0.041
74020649|NCT01756456|147593877|SUPERIORITY||Odds Ratio (OR)|1.95|||=|0.081|TWO_SIDED|95.0|0.92|4.11|||Chi-squared|||week 4||4.11|0.92|=0.081
74020650|NCT01756456|147593877|SUPERIORITY||Odds Ratio (OR)|2.47|||=|0.04|TWO_SIDED|95.0|1.04|5.88|||Chi-squared|||week 8||5.88|1.04|=0.040
74020651|NCT01756456|147593877|SUPERIORITY||Odds Ratio (OR)|1.93|||=|0.132|TWO_SIDED|95.0|0.82|4.52|||Chi-squared|||week 8||4.52|0.82|=0.132
74020652|NCT01756456|147593882|SUPERIORITY||difference in percentage|15.8|||=|0.097|TWO_SIDED|95.0|-2.36|33.97|||Chi-squared|||week 4||33.97|-2.36|=0.097
74020653|NCT01756456|147593882|SUPERIORITY||difference in percentage|13.2|||=|0.175|TWO_SIDED|95.0|-5.72|32.15|||Chi-squared|||week 4||32.15|-5.72|=0.175
74020654|NCT01756456|147593882|SUPERIORITY||difference in percentage|16.9|||=|0.105|TWO_SIDED|95.0|-3.11|37.0|||Chi-squared|||week 6||37.00|-3.11|=0.105
74020655|NCT01756456|147593882|SUPERIORITY||difference in percentage|11.0|||=|0.3|TWO_SIDED|95.0|-9.64|31.57|||Chi-squared|||week 6||31.57|-9.64|=0.300
74020656|NCT01756456|147593882|SUPERIORITY||difference in percentage|27.5|||=|0.008|TWO_SIDED|95.0|8.33|46.67|||Chi-squared|||week 8||46.67|8.33|=0.008
74020657|NCT01756456|147593882|SUPERIORITY||difference in percentage|19.0|||=|0.068|TWO_SIDED|95.0|-0.91|38.83|||Chi-squared|||week 8||38.83|-0.91|=0.068
74020658|NCT02411747|147593888|NON_INFERIORITY_OR_EQUIVALENCE|Beta: 0.8, p significant if p \> 0.005||||||0.34|||||||t-test, 2 sided|||Independent samples t-test||||0.34
74020659|NCT00848120|147593919|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Week 24 versus baseline||||<0.001
74020660|NCT00848120|147593920|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Week 24 versus baseline||||<0.001
74020661|NCT00848120|147593921|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||Week 24 versus baseline||||0.001
74020662|NCT02116621|147593928|SUPERIORITY||Adjusted difference in differences|-1.36|||||TWO_SIDED|95.0|-2.91|0.19|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|||0.19|-2.91|
74020663|NCT02116621|147593929|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: -0.79 (-2.37 to 0.80); baseline to 26 weeks: -1.36 (-2.91 to 0.19); baseline to 52 weeks: 0.16 (-1.47 to 1.79)|||0.21
74020664|NCT02116621|147593930|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.31 (-1.18 to 1.81); baseline to 26 weeks: -1.41 (-2.87 to 0.06); baseline to 52 weeks: -1.24 (-2.77 to 0.30)|||0.06
74020665|NCT02116621|147593931|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks:-0.66 (-2.55 to 1.24); baseline to 26 weeks: 0.93 (-0.92 to 2.79); baseline to 52 weeks: 0.76 (-1.19 to 2.70)|||0.35
74020666|NCT02116621|147593932|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.30 (-1.01 to 1.61); baseline to 26 weeks: -0.17 (-1.45 to 1.12); baseline to 52 weeks: -0.26 (-1.61 to 1.09)|||0.86
74020667|NCT02116621|147593933|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.05 (-2.54 to 4.64); baseline to 26 weeks: 1.90 (-1.66 to 5.47); baseline to 52 weeks: 0.08 (-3.61 to 3.77).|||0.70
73959028|NCT00355914|147453813|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||baseline, 3, 6, 12, 18, and 24 months between groups||||>0.05
73959029|NCT03823300|147453814|NON_INFERIORITY|If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.7|1.8|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.||1.8|-1.7|
73959030|NCT03823300|147453815|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-2.4|1.3|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||1.3|-2.4|
73959031|NCT03823300|147453817|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-8.3|4.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥15 Letters: Treatment Difference at Weeks 40-48||4.3|-8.3|
73959032|NCT03823300|147453817|OTHER||Difference in CMH Weighted Percentage|3.4|||||TWO_SIDED|95.0|-3.9|10.7|||||The treatment difference in CMH weighted percentage of participants gaining ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥10 Letters: Treatment Difference at Weeks 40-48||10.7|-3.9|
73959033|NCT03823300|147453817|OTHER||Difference in CMH Weighted Percentage|1.0|||||TWO_SIDED|95.0|-6.6|8.6|||||The treatment difference in CMH weighted percentage of participants gaining ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥5 Letters: Treatment Difference at Weeks 40-48||8.6|-6.6|
73959034|NCT03823300|147453817|OTHER||Difference in CMH Weighted Percentage|3.1|||||TWO_SIDED|95.0|-3.1|9.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥0 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥0 Letters: Treatment Difference at Weeks 40-48||9.3|-3.1|
73959035|NCT03823300|147453818|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-7.7|5.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||5.3|-7.7|
73959036|NCT03823300|147453823|OTHER||Difference in CMH Weighted Percentage|-1.5|||||TWO_SIDED|95.0|-4.4|1.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥15 Letters: Treatment Difference at Weeks 40-48||1.3|-4.4|
73959037|NCT03823300|147453823|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-4.5|2.8|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥10 Letters: Treatment Difference at Weeks 40-48||2.8|-4.5|
73959038|NCT03823300|147453823|OTHER||Difference in CMH Weighted Percentage|2.6|||||TWO_SIDED|95.0|-2.1|7.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥5 Letters: Treatment Difference at Weeks 40-48||7.3|-2.1|
73959039|NCT03823300|147453824|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-2.6|3.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||3.3|-2.6|
73959040|NCT03823300|147453828|OTHER||Difference in CMH Weighted Percentage|-1.7|||||TWO_SIDED|95.0|-8.5|5.1|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters or achieving BCVA ≥84 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||5.1|-8.5|
73959041|NCT03823300|147453830|OTHER||Difference in CMH Weighted Percentage|5.7|||||TWO_SIDED|95.0|-1.4|12.9|||||The treatment difference in CMH weighted percentage of participants achieving BCVA ≥69 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||12.9|-1.4|
73959042|NCT03823300|147453832|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-3.6|4.4|||||The treatment difference in CMH weighted percentage of participants with BCVA ≤38 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||4.4|-3.6|
73959043|NCT03823300|147453840|OTHER||Adjusted mean difference|-6.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-14.8|2.1|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 40-48||2.1|-14.8|
73959044|NCT03823300|147453841|OTHER||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|4.05|||TWO_SIDED|95.0|-6.6|9.3|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||9.3|-6.6|
73959045|NCT00964366|147453901|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|||||||> 0.05
73959046|NCT00964366|147453903|SUPERIORITY_OR_OTHER||||||<|0.05||||||Dapsone versus Clindamycin/BPO gel.|Dunn's Multiple Comparisons Test|||||||< 0.05
73959047|NCT00964366|147453904|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73959048|NCT00964366|147453905|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74020668|NCT02116621|147593934|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 4.24 (-2.73 to 11.20); baseline to 26 weeks: 4.64 (-2.25 to 11.54); baseline to 52 weeks: -1.91 (-9.07 to 5.26).|||0.20
74020669|NCT02116621|147593935|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.76 (-2.37 to 5.89); baseline to 26 weeks: 2.55 (-1.50 to 6.60); baseline to 52 weeks: 1.53 (-2.70 to 5.77).|||0.66
74020670|NCT02116621|147593936|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 7.77 (-2.87 to 18.42); baseline to 26 weeks: 7.29 (-3.16 to 17.75); baseline to 52 weeks: 4.13 (-6.81 to 15.07).|||0.44
74020671|NCT02116621|147593937|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 2.15 (-2.84 to 7.13); baseline to 26 weeks: 3.31 (-1.57 to 8.19); baseline to 52 weeks: 1.00 (-4.11 to 6.11).|||0.58
74020672|NCT02116621|147593938|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.81 (-4.41 to 8.02); baseline to 26 weeks: -1.57 (-7.68 to 4.54); baseline to 52 weeks: 1.11 (-5.27 to 7.48).|||0.73
74020673|NCT02116621|147593939|SUPERIORITY||Adjusted difference in differences|-1.41|||||TWO_SIDED|95.0|-2.87|0.06|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|||0.06|-2.87|
74020674|NCT02116621|147593940|SUPERIORITY||Adjusted difference in differences|0.93|||||TWO_SIDED|95.0|-0.92|2.79|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|2.79|-0.92|
74020675|NCT02116621|147593941|SUPERIORITY||Adjusted difference in differences|-0.17|||||TWO_SIDED|95.0|-1.45|1.12|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|1.12|-1.45|
74020676|NCT02116621|147593942|SUPERIORITY||Adjusted difference in differences|1.9|||||TWO_SIDED|95.0|-1.66|5.47|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|5.47|-1.66|
74020677|NCT02116621|147593943|SUPERIORITY||Adjusted difference in differences|4.64|||||TWO_SIDED|95.0|-2.25|11.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|11.54|-2.25|
74020678|NCT02116621|147593944|SUPERIORITY||Adjusted difference in differences|2.55|||||TWO_SIDED|95.0|-1.5|6.6|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|6.60|-1.50|
74020679|NCT02116621|147593945|SUPERIORITY||Adjusted difference in differences|7.29|||||TWO_SIDED|95.0|-3.16|17.75|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|17.75|-3.16|
74020680|NCT02116621|147593946|SUPERIORITY||Adjusted difference in differences|3.31|||||TWO_SIDED|95.0|-1.57|8.19|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|8.19|-1.57|
73898107|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74020681|NCT02116621|147593947|SUPERIORITY||Adjusted difference in differences|-1.57|||||TWO_SIDED|95.0|-7.68|4.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|4.54|-7.68|
74020682|NCT02116621|147593948|SUPERIORITY||Mean Difference (Final Values)|11.9||||0.01|TWO_SIDED|95.0|2.59|21.24|||Regression, Linear|||||21.24|2.59|0.01
74020683|NCT02116621|147593949|SUPERIORITY||Adjusted difference in differences|-0.79|||||TWO_SIDED|95.0|-2.37|0.8|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||0.80|-2.37|
74020684|NCT02116621|147593950|SUPERIORITY||Adjusted difference in differences|0.31|||||TWO_SIDED|95.0|-1.18|1.81|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.81|-1.18|
74020685|NCT02116621|147593951|SUPERIORITY||Adjusted difference in differences|0.3|||||TWO_SIDED|95.0|-1.01|1.61|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.61|-1.01|
74020686|NCT02116621|147593952|SUPERIORITY||Adjusted difference in differences|-0.66|||||TWO_SIDED|95.0|-2.55|1.24|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.24|-2.55|
74020687|NCT02116621|147593953|SUPERIORITY||Adjusted difference in differences|1.05|||||TWO_SIDED|95.0|-2.54|4.64|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||4.64|-2.54|
74020688|NCT02116621|147593954|SUPERIORITY||Adjusted difference in differences|4.24|||||TWO_SIDED|95.0|-2.73|11.2|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||11.20|-2.73|
74020689|NCT02116621|147593955|SUPERIORITY||Adjusted difference in differences|1.76|||||TWO_SIDED|95.0|-2.37|5.89|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||5.89|-2.37|
74020690|NCT02116621|147593956|SUPERIORITY||Adjusted difference in differences|7.77|||||TWO_SIDED|95.0|-2.87|18.42|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||18.42|-2.87|
74020691|NCT02116621|147593957|SUPERIORITY||Adjusted difference in differences|2.15|||||TWO_SIDED|95.0|-2.84|7.13|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||7.13|-2.84|
74020692|NCT02116621|147593958|SUPERIORITY||Adjusted difference in differences|1.81|||||TWO_SIDED|95.0|-4.41|8.02|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||8.02|-4.41|
74020693|NCT02116621|147593959|SUPERIORITY||Adjusted difference in differences|0.16|||||TWO_SIDED|95.0|-1.47|1.79|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||1.79|-1.47|
74020694|NCT02116621|147593960|SUPERIORITY||Adjusted difference in differences|-1.24|||||TWO_SIDED|95.0|-2.77|0.3|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||0.30|-2.77|
74020695|NCT02116621|147593961|SUPERIORITY||Adjusted difference in differences|-0.26|||||TWO_SIDED|95.0|-1.61|1.09|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||1.09|-1.61|
74020696|NCT02116621|147593962|SUPERIORITY||Adjusted difference in differences|0.76|||||TWO_SIDED|95.0|-1.19|2.7|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||2.70|-1.19|
74020697|NCT02116621|147593963|SUPERIORITY||Adjusted difference in differences|0.08|||||TWO_SIDED|95.0|-3.61|3.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||3.77|-3.61|
74020698|NCT02116621|147593964|SUPERIORITY||Adjusted difference in differences|-1.91|||||TWO_SIDED|95.0|-9.07|5.26|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||5.26|-9.07|
74020699|NCT02116621|147593965|SUPERIORITY||Adjusted difference in differences|1.53|||||TWO_SIDED|95.0|-2.7|5.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||5.77|-2.70|
74020700|NCT02116621|147593966|SUPERIORITY||Adjusted difference in differences|4.13|||||TWO_SIDED|95.0|-6.81|15.07|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||15.07|-6.81|
74020701|NCT02116621|147593967|SUPERIORITY||Adjusted difference in differences|1.0|||||TWO_SIDED|95.0|-4.11|6.11|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||6.11|-4.11|
74020702|NCT02116621|147593968|SUPERIORITY||Adjusted difference in differences|1.11|||||TWO_SIDED|95.0|-5.27|7.48|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||7.48|-5.27|
74020703|NCT02116621|147593969|SUPERIORITY||Mean Difference (Final Values)|9.41||||0.054|TWO_SIDED|95.0|-0.15|18.96|||Regression, Linear|||||18.96|-0.15|0.054
74020704|NCT01412957|147593974|SUPERIORITY_OR_OTHER||Normal score|-2.59||||0.0096|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|The primary hypothesis was that panitumumab plus BSC would improve overall survival compared to BSC alone. A comparison between treatments was performed using the log-rank test stratified by the randomization factors at a 5% significance level.||||0.0096
74020705|NCT01412957|147593975|SUPERIORITY_OR_OTHER||Normal score|-6.08|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the ITT Analysis Set was tested at a significance level of 5% conditional on a significant treatment effect on overall survival in the ITT Analysis Set.||||<0.0001
74020706|NCT01412957|147593976|SUPERIORITY_OR_OTHER||Normal score|-2.47||||0.0135|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|Overall survival in the Wild-type RAS Efficacy Analysis Set was compared at a significance level of 5% conditional on a significant treatment effect for progression-free survival in the ITT Analysis Set.||||0.0135
73898108|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.145||0.662|TWO_SIDED|95.0|-0.348|0.221||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.221|-0.348|0.662
74020707|NCT01412957|147593977|SUPERIORITY_OR_OTHER||Normal score|-5.98|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the Wild-type RAS Efficacy Analysis Set was to be compared at a significance level of 5% if overall survival in the wild-type RAS Efficacy Anaysis Set demonstrated a significant treatment effect.||||<0.0001
74020708|NCT01412957|147593978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.89|||<|0.0001|TWO_SIDED|95.0|7.47|123.77|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.||123.77|7.47|<0.0001
74020709|NCT01412957|147593979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0|||<|0.0001|TWO_SIDED|95.0|5.89|101.62|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.||101.62|5.89|<0.0001
74020710|NCT04722991|147593988|OTHER|Bayesian inference with non-informative priors|Point estimate|-0.015|||||TWO_SIDED|95.0|-0.08|0.029|||||Median of posterior distribution|||0.029|-0.080|
74020711|NCT04343651|147594000|SUPERIORITY|||||||0.818|||||||ANCOVA|||||||0.818
74020712|NCT04343651|147594001|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.4138|TWO_SIDED|95.0|0.43|1.41|||Likelihood test-Cox Prop. hazards model|Stratification factors: Baseline NEWS Total score and Age.||||1.41|0.43|0.4138
74020713|NCT02246621|147594017|SUPERIORITY||Hazard Ratio (HR)|0.54||||2e-06|TWO_SIDED|95.0|0.418|0.698|||Log Rank|||||0.698|0.418|0.000002
73898109|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898110|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.141||0.849|TWO_SIDED|95.0|-0.25|0.304||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.304|-0.250|0.849
73898111|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898112|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.145||0.995|TWO_SIDED|95.0|-0.286|0.284||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.284|-0.286|0.995
73898113|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898114|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.161||0.707|TWO_SIDED|95.0|-0.256|0.378||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.378|-0.256|0.707
73898115|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898116|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.159||0.901|TWO_SIDED|95.0|-0.294|0.333||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.333|-0.294|0.901
73898117|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898118|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.161||0.451|TWO_SIDED|95.0|-0.195|0.439||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.439|-0.195|0.451
73898119|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898120|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.185||0.722|TWO_SIDED|95.0|-0.429|0.298||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.298|-0.429|0.722
73898121|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898122|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.181||0.42|TWO_SIDED|95.0|-0.503|0.21||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.210|-0.503|0.420
73898123|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898124|NCT02880956|147328876|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.187||0.498|TWO_SIDED|95.0|-0.495|0.241||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.241|-0.495|0.498
73898125|NCT02880956|147328876|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898126|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.071||0.975|TWO_SIDED|95.0|-0.138|0.142||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.142|-0.138|0.975
73898127|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898128|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.078|TWO_SIDED|95.0|-0.014|0.261||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.261|-0.014|0.078
73898129|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898130|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.072||0.514|TWO_SIDED|95.0|-0.188|0.094||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.094|-0.188|0.514
74020714|NCT02246621|147594019|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
74020715|NCT02246621|147594021|SUPERIORITY|||||||0.501|||||||Cochran-Mantel-Haenszel|||||||0.501
74020716|NCT02246621|147594022|SUPERIORITY|||||||0.101|||||||Cochran-Mantel-Haenszel|||||||0.101
74020717|NCT02246621|147594026|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.688|TWO_SIDED||||||Mixed Models Analysis|||||||0.688
74020718|NCT02246621|147594027|SUPERIORITY||Mean Difference (Net)|-1.01|STANDARD_ERROR_OF_MEAN|1.39||0.466|TWO_SIDED||||||Mixed Models Analysis|||||||0.466
74020719|NCT02761967|147594052|EQUIVALENCE|The statistical power of the study for the temporal variables was 82%. Multiple linear regression models were obtained for the first and second stages and for the total duration of delivery.||||||0.776|||||||Chi-squared|||||||0.776
74020720|NCT03136107|147594055|EQUIVALENCE|Statistical criterion defined in ISO 24444:2010 is that the 95 %CI is within ±17 % of the mean SPF||||||||||||||||CI % values (which is the percentage that half the 95 % CI represents of the mean values).|Test product CI of ±16.4% and reference product CI of ±16.6% of the mean SPF.|||
74020721|NCT02292771|147594071|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.3797|TWO_SIDED|95.0|-8.879|6.479|||Finite mixture model|||||6.479|-8.879|0.3797
74020722|NCT02292771|147594072|SUPERIORITY||Odds Ratio (OR)|1.0||||0.952|TWO_SIDED|95.0|0.44|2.18|||Regression, Logistic|||||2.18|0.44|0.9520
74020723|NCT02292771|147594073|SUPERIORITY||Odds Ratio (OR)|1.0||||0.952|TWO_SIDED|95.0|0.46|2.29|||Regression, Logistic|||||2.29|0.46|0.9520
74020724|NCT02292771|147594074|SUPERIORITY||Ratio|1.14|STANDARD_ERROR_OF_MEAN|0.222||0.5672|TWO_SIDED|95.0|0.73|1.76|||ANCOVA|||||1.76|0.73|0.5672
74020725|NCT02292771|147594075|SUPERIORITY||Odds Ratio (OR)|1.9||||0.5066|TWO_SIDED|95.0|0.3|11.71|||Regression, Logistic|||||11.71|0.30|0.5066
74020726|NCT02292771|147594081|SUPERIORITY||Odds Ratio (OR)|0.8||||0.779|TWO_SIDED|95.0|0.12|4.84|||Regression, Logistic|||||4.84|0.12|0.7790
74020727|NCT02292771|147594082|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6646|TWO_SIDED|95.0|0.51|2.9|||Regression, Logistic|||||2.90|0.51|0.6646
74020728|NCT02292771|147594083|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1432|TWO_SIDED|95.0|0.75|7.24|||Regression, Logistic|||||7.24|0.75|0.1432
74020729|NCT02292771|147594084|SUPERIORITY||Odds Ratio (OR)|1.5||||0.525|TWO_SIDED|95.0|0.43|5.15|||Regression, Logistic|||||5.15|0.43|0.5250
74020730|NCT02292771|147594085|SUPERIORITY||Odds Ratio (OR)|0.6||||0.4682|TWO_SIDED|95.0|0.13|2.58|||Regression, Logistic|||||2.58|0.13|0.4682
74020731|NCT02274688|147594113|SUPERIORITY||||||=|0.01|||||||Wald Chi-Square=11.29, df=3, P=0.01|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.01
74020732|NCT02274688|147594114|SUPERIORITY||||||=|0.23|||||||Wald Chi-Square=3.01, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.23
74020733|NCT02274688|147594115|SUPERIORITY||||||=|0.23|||||||Wald Chi-Square=4.25, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.23
74020734|NCT02274688|147594116|SUPERIORITY||||||=|0.55|||||||Wald Chi-Square=2.12, df=3, p=0.55|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.55
74020735|NCT02274688|147594117|SUPERIORITY||||||=|0.32|||||||Wald Chi-Square=3.52, df=3; p=0.32|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.32
74020736|NCT02274688|147594118|SUPERIORITY||||||=|0.26|||||||Wald Chi-Square=4.02, df=3, p=0.26|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.26
74020737|NCT02274688|147594119|SUPERIORITY||||||=|0.22|||||||Wald Chi-Square=4.44, df=3, p=0.22|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.22
74020738|NCT02274688|147594120|SUPERIORITY||||||=|0.08||||||F(3,507)=2.24, P=0.08|Regression Poisson|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.08
74020739|NCT02274688|147594121|SUPERIORITY|||||||0.36|||||||Wald Chi-Square=3.24, df=3, p=0.36|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||0.36
74020740|NCT04574999|147594131|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74020741|NCT04574999|147594132|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74020742|NCT04574999|147594134|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74020743|NCT04574999|147594135|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74020744|NCT00008385|147594137|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.25||||0.294|TWO_SIDED|95.0|0.64|2.37||This p value should be compared to the nominal p value of 0.0035 adjusting for the previous interim analyses|Log Rank||The 95% confidence interval was repeated confidence interval for the risk ratio|||2.37|0.64|0.294
74080987|NCT02997176|147713968|OTHER|Bioequivalence|Percent Ratio of Geometric Means|95.68|||||TWO_SIDED|90.0|67.9|134.83||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||134.83|67.90|
74020745|NCT00008385|147594138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|TWO_SIDED||||||Log Rank|||||||0.069
74020746|NCT00008385|147594139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|TWO_SIDED||||||Log Rank|||||||0.154
74020747|NCT01993888|147594150|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74020748|NCT02162862|147594201|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
74020749|NCT02162862|147594201|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
74020750|NCT02162862|147594201|OTHER|||||||0.102|||||||t-test, 2 sided|||||||.102
74020751|NCT02162862|147594202|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
74020752|NCT02162862|147594202|OTHER|||||||0.646|||||||t-test, 2 sided|||||||.646
74020753|NCT02162862|147594202|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
74020754|NCT00432237|147594244|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020755|NCT00432237|147594244|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020756|NCT00432237|147594245|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020757|NCT00432237|147594245|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020758|NCT00432237|147594246|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020759|NCT00432237|147594246|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020760|NCT00432237|147594247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020761|NCT00432237|147594247|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020762|NCT00432237|147594248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020763|NCT00432237|147594248|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020764|NCT00432237|147594249|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020765|NCT00432237|147594249|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020766|NCT00432237|147594250|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020767|NCT00432237|147594250|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020768|NCT00432237|147594251|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020769|NCT00432237|147594251|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
74020770|NCT01354132|147594252|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
74020771|NCT01354132|147594253|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.39
74020772|NCT01354132|147594254|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
74020773|NCT01354132|147594255|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
74020774|NCT01354132|147594256|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||Speed of Processing||||0.022
74020775|NCT01354132|147594257|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||||||0.270
74020776|NCT01354132|147594258|SUPERIORITY|||||||0.153|||||||t-test, 2 sided|||||||0.153
74020777|NCT01354132|147594259|SUPERIORITY|||||||0.876|||||||t-test, 2 sided|||||||0.876
74020778|NCT01354132|147594260|SUPERIORITY|||||||0.464|||||||t-test, 2 sided|||||||0.464
74020779|NCT01354132|147594261|SUPERIORITY|||||||0.741|||||||t-test, 2 sided|||||||0.741
74020780|NCT01354132|147594262|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
74020781|NCT01354132|147594263|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
74020782|NCT01354132|147594264|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
74020783|NCT01354132|147594265|SUPERIORITY|||||||0.6732|||||||t-test, 1 sided|||||||0.6732
74020784|NCT01354132|147594266|SUPERIORITY|||||||0.8786|||||||t-test, 2 sided|||||||0.8786
74020785|NCT01354132|147594267|SUPERIORITY|||||||0.5622|||||||t-test, 2 sided|||||||0.5622
74020786|NCT01354132|147594268|SUPERIORITY|||||||0.9574|||||||t-test, 2 sided|||||||0.9574
74020787|NCT01354132|147594269|SUPERIORITY|||||||0.0043|||||||t-test, 2 sided|||||||0.0043
74020788|NCT01354132|147594270|SUPERIORITY|||||||0.3804|||||||t-test, 2 sided|||||||0.3804
74020789|NCT01354132|147594271|SUPERIORITY|||||||0.9403|||||||t-test, 2 sided|||||||0.9403
74020790|NCT01354132|147594272|SUPERIORITY|||||||0.9215|||||||t-test, 2 sided|||||||0.9215
74080988|NCT02997176|147713969|OTHER|Bioequivalence|Percent Ratio of Geometric Means|99.31|||||TWO_SIDED|90.0|57.74|170.8||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||170.80|57.74|
74020791|NCT00603239|147594273|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustments were made (alpha = 0.05).|ANCOVA|No adjustments for multiplicity were made.||Null hypothesis = Change from baseline in HbA1c is equal between the two treatment groups. Greater than 99% power to detect a difference between treatment groups of 0.88% in change in HbA1c from baseline using a 2-sided t-test at a significance level of 0.05.||||<0.001
74020792|NCT00603239|147594274|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects with HbA1c \<= 7% is equal between the two treatment groups.||||0.113
74020793|NCT00603239|147594275|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects achieving HbA1c \<= 6.5% is equal between the two treatment groups.||||0.004
74020794|NCT00603239|147594276|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in FSG is equal between the two treatment groups.||||0.009
74020795|NCT00603239|147594277|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline to endpoint in body weight is equal between the two treatment groups.||||0.176
74020796|NCT00603239|147594279|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change form baseline in HOMA-B is equal between the two treatment groups.||||0.009
74020797|NCT00603239|147594280|SUPERIORITY_OR_OTHER|||||||0.794||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in HOMA-S is equal between the two treatment groups.||||0.794
74020798|NCT00603239|147594281|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments (alpha = 0.05).|Fisher Exact|No adjustment for multiplicity.||Null hypothesis = Incidence of minor hypoglycemia episodes is equal between the two treatment groups.||||1.00
74020799|NCT00603239|147594282|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in IWQOL-Lite Total Score is equal between the two treatment groups. This statistical analysis is for the Total Score only.||||0.342
74020800|NCT00603239|147594283|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||No adjustments (alpha = 0.05)|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in EQ-5D score is equal between the two treatment groups. This statistical analysis is for the EQ-5D Health State Score only.||||0.186
74020801|NCT02357420|147594284|SUPERIORITY|||||||0.36|||||||Measures mixed effects model (MMRM)|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.36
74020802|NCT02357420|147594284|SUPERIORITY|||||||0.25|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.25
74020803|NCT02357420|147594284|SUPERIORITY|||||||0.59|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.59
74020804|NCT00928070|147594289|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.21||0.0018|TWO_SIDED|95.0|-1.05|-0.24||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.||-0.24|-1.05|0.0018
74020805|NCT00928070|147594290|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.27|-0.38||Statistical testing, two-sided, was done at 5% significance level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.||-0.38|-1.27|0.0003
74020806|NCT00928070|147594291|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
74020807|NCT00928070|147594291|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0001
74020808|NCT00928070|147594293|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24||0.0003|TWO_SIDED|95.0|-1.35|-0.4||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.||-0.40|-1.35|0.0003
74020809|NCT00928070|147594293|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.29|-0.39||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.||-0.39|-1.29|0.0003
74020810|NCT00928070|147594294|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
74020811|NCT00928070|147594294|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
74020812|NCT00928070|147594296|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0014|TWO_SIDED|95.0|-1.77|-0.43||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.43|-1.77|0.0014
74080989|NCT02997176|147713969|OTHER|Bioequivalence|Percent Ratio of Geometric Means|96.45|||||TWO_SIDED|90.0|52.22|178.14||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||178.14|52.22|
74020813|NCT00928070|147594296|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.1|-0.7||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.70|-2.10|<0.0001
73898131|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.47|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898132|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.102||0.107|TWO_SIDED|95.0|-0.367|0.036||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.036|-0.367|0.107
73898133|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898134|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.099||0.425|TWO_SIDED|95.0|-0.275|0.116||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.116|-0.275|0.425
73898135|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898136|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.102||0.039|TWO_SIDED|95.0|-0.413|-0.011||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||-0.011|-0.413|0.039
73898137|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|0.28|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898138|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.131||0.729|TWO_SIDED|95.0|-0.302|0.212||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.212|-0.302|0.729
73898139|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898140|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.128||0.671|TWO_SIDED|95.0|-0.198|0.307||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.307|-0.198|0.671
73898141|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898142|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.13||0.876|TWO_SIDED|95.0|-0.235|0.276||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.276|-0.235|0.876
73898143|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898144|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.159||0.763|TWO_SIDED|95.0|-0.266|0.362||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.362|-0.266|0.763
73898145|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898146|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.157||0.429|TWO_SIDED|95.0|-0.434|0.185||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.185|-0.434|0.429
73898147|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898148|NCT02880956|147328877|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.162||0.701|TWO_SIDED|95.0|-0.256|0.381||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.381|-0.256|0.701
73898149|NCT02880956|147328877|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|1.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898150|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.064||0.867|TWO_SIDED|95.0|-0.115|0.137||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.137|-0.115|0.867
74080990|NCT02997176|147713969|OTHER|Bioequivalence|Percent Ratio of Geometric Means|64.05|||||TWO_SIDED|90.0|39.65|103.46||||||Cmax was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||103.46|39.65|
74020814|NCT00928070|147594297|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0002
74020815|NCT00928070|147594297|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
74020816|NCT00928070|147594299|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2511|TWO_SIDED|95.0|-0.39|0.1||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.||0.10|-0.39|0.2511
74020817|NCT00928070|147594299|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.0189|TWO_SIDED|95.0|-0.53|-0.05||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.||-0.05|-0.53|0.0189
74020818|NCT00928070|147594300|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% significance level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0010
74020819|NCT00928070|147594302|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.67|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.04|-2.3||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-2.30|-7.04|0.0001
74020820|NCT00928070|147594302|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.97|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-7.27|-2.66||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-2.66|-7.27|<0.0001
74020821|NCT00928070|147594303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.0035|TWO_SIDED|95.0|-0.56|-0.11||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: =\<3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<3.5/day and \>3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||-0.11|-0.56|0.0035
74020822|NCT00928070|147594303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.21||0.7089|TWO_SIDED|95.0|-2.01|2.92||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: \>3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<3.5/day and \>3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||2.92|-2.01|0.7089
74020823|NCT00928070|147594303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: =\<2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<2.5/day and \>2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||-0.21|-0.61|<0.0001
74020824|NCT00928070|147594303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.47||0.7437|TWO_SIDED|95.0|-0.78|1.09||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: \>2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<2.5/day and \>2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||1.09|-0.78|0.7437
74020825|NCT00928070|147594304|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 4- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for center was used to calculate p-value.||||0.0009
74020826|NCT00928070|147594304|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: CMH test with modified ridit scoring controlling for center was used to calculate p-value.||||0.0021
74020827|NCT00928070|147594306|SUPERIORITY_OR_OTHER||Least squares mean difference|-9.15|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-12.85|-5.45||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-5.45|-12.85|<0.0001
74020828|NCT00928070|147594306|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.03||0.0002|TWO_SIDED|95.0|-11.6|-3.61||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-3.61|-11.60|0.0002
74020829|NCT00928070|147594308|SUPERIORITY_OR_OTHER||Least squares mean difference|8.17|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|4.09|12.25||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||12.25|4.09|<0.0001
74020830|NCT00928070|147594308|SUPERIORITY_OR_OTHER||Least squares mean difference|6.96|STANDARD_ERROR_OF_MEAN|2.13||0.0012|TWO_SIDED|95.0|2.77|11.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||11.15|2.77|0.0012
74020831|NCT00928070|147594308|SUPERIORITY_OR_OTHER||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|2.01||0.0472|TWO_SIDED|95.0|0.05|7.95||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||7.95|0.05|0.0472
74020832|NCT00928070|147594308|SUPERIORITY_OR_OTHER||Least squares mean difference|2.46|STANDARD_ERROR_OF_MEAN|1.53||0.1087|TWO_SIDED|95.0|-0.55|5.46||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.46|-0.55|0.1087
74020833|NCT00928070|147594308|SUPERIORITY_OR_OTHER||Least squares mean difference|5.79|STANDARD_ERROR_OF_MEAN|1.77||0.0012|TWO_SIDED|95.0|2.31|9.28||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.28|2.31|0.0012
74020834|NCT00928070|147594308|SUPERIORITY_OR_OTHER||Least squares mean difference|9.04|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|4.75|13.33||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||13.33|4.75|<0.0001
74020835|NCT00928070|147594308|SUPERIORITY_OR_OTHER||Least squares mean difference|5.32|STANDARD_ERROR_OF_MEAN|2.22||0.0169|TWO_SIDED|95.0|0.96|9.67||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.67|0.96|0.0169
74020836|NCT00928070|147594308|SUPERIORITY_OR_OTHER||Least squares mean difference|4.05|STANDARD_ERROR_OF_MEAN|2.1||0.0546|TWO_SIDED|95.0|-0.08|8.17||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||8.17|-0.08|0.0546
74020837|NCT00928070|147594308|SUPERIORITY_OR_OTHER||Least squares mean difference|2.35|STANDARD_ERROR_OF_MEAN|1.63||0.1497|TWO_SIDED|95.0|-0.85|5.55||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.55|-0.85|0.1497
74020838|NCT00928070|147594308|SUPERIORITY_OR_OTHER||Least squares mean difference|5.53|STANDARD_ERROR_OF_MEAN|1.88||0.0034|TWO_SIDED|95.0|1.84|9.23||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.23|1.84|0.0034
74020839|NCT00928070|147594309|SUPERIORITY_OR_OTHER||Least squares mean difference|16.25|STANDARD_ERROR_OF_MEAN|2.96|<|0.0001|TWO_SIDED|95.0|10.43|22.08||Statistical testing, two-sided, was done at 5% significance level.|ANOVA|||ANOVA model with treatment and center as factors was used to calculate p-value.||22.08|10.43|<0.0001
74080991|NCT02997176|147713972|OTHER|Bioequivalence|Percent Ratio of Geometric Means|118.47|||||TWO_SIDED|90.0|83.81|167.47||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||167.47|83.81|
74080992|NCT02997176|147713972|OTHER|Bioequivalence|Percent Ratio of Geometric Means|108.36|||||TWO_SIDED|90.0|73.25|160.3||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||160.30|73.25|
74080993|NCT02997176|147713972|OTHER|Bioequivalence|Percent Ratio of Geometric Means|117.84|||||TWO_SIDED|90.0|85.29|162.83||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||162.83|85.29|
74020840|NCT00928070|147594310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Not satisfied, neither dissatisfied nor satisfied, satisfied: CMH test with modified ridit scoring controlling for center was used.||||<0.0001
74020841|NCT00928070|147594312|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.2788|TWO_SIDED|95.0|-0.51|0.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline value, and centered baseline by treatment interaction.||0.15|-0.51|0.2788
74020842|NCT00928070|147594313|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0||||0.0021|TWO_SIDED|95.0|0.0|8.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 4: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.||8.00|0.00|0.0021
74020843|NCT00928070|147594313|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.0|||<|0.0001|TWO_SIDED|95.0|3.0|11.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 12: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.||11.00|3.00|<0.0001
74020844|NCT02348099|147594324|OTHER|"A student's paired t-test will be used to determine the difference if any in CV of Glucose between injection sites. In the third phase, area under the curve will be measured to determine differences between insulin absorption levels. Statistical analysis will be performed using SPSS version 15.0.0 and SAS version 8.2 A power calculation is a statistical method used to determine the minimum sample size needed to detect a statistically significant effect of a certain size."|Odds Ratio (OR)|95.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||"A student's paired t-test will be used to determine the difference if any in CV of glucose between injection sited.~If the null hypothesis is true, it suggests that any changes witnessed in an experiment are because of random chance and not because of changes made to variables in the experiment. A power calculation is a statistical method used to determine the minimum sample size needed to detect a statistically significant effect of a certain size."|a P-Value is \<0.01|||<0.01
74020845|NCT02411448|147594390|OTHER||Hazard Ratio (HR)|0.591|||<|0.0001|TWO_SIDED|95.0|0.461|0.76|||Log Rank|||||0.760|0.461|<0.0001
74020846|NCT02411448|147594392|OTHER||Hazard Ratio (HR)|0.832||||0.4209|TWO_SIDED|95.0|0.532|1.303|||Log Rank|||||1.303|0.532|0.4209
74020847|NCT02411448|147594393|OTHER|||||||0.7413|||||||Cochran-Mantel-Haenszel|||||||0.7413
74020848|NCT02411448|147594394|OTHER|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
74020849|NCT02411448|147594395|OTHER||Hazard Ratio (HR)|0.619||||0.0003|TWO_SIDED|95.0|0.477|0.805|||Log Rank|||||0.805|0.477|0.0003
74020850|NCT01256177|147594416|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.22|STANDARD_ERROR_OF_MEAN|1.1||0.004|TWO_SIDED|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)||-1.04|-5.39|0.004
74020851|NCT01256177|147594417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54||||0.001|TWO_SIDED|95.0|1.56|4.13|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo|||4.13|1.56|0.001
74020852|NCT01256177|147594418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.001|TWO_SIDED|95.0|1.46|3.86|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo|||3.86|1.46|0.001
74020853|NCT01256177|147594419|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-1.47|STANDARD_ERROR_OF_MEAN|0.67||0.029|TWO_SIDED|95.0|-2.79|-0.15|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 1 in MADRS total score based on observed cases (OC)||-0.15|-2.79|0.029
74020854|NCT01256177|147594419|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.43|STANDARD_ERROR_OF_MEAN|0.88||0.006|TWO_SIDED|95.0|-4.16|-0.69|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 2 in MADRS total score based on observed cases (OC)||-0.69|-4.16|0.006
74020855|NCT01256177|147594419|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.12|STANDARD_ERROR_OF_MEAN|0.95||0.001|TWO_SIDED|95.0|-5.0|-1.25|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 4 in MADRS total score based on observed cases (OC)||-1.25|-5.00|0.001
74020856|NCT01256177|147594419|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.08|STANDARD_ERROR_OF_MEAN|1.03||0.045|TWO_SIDED|95.0|-4.12|-0.05|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 6 in MADRS total score based on observed cases (OC)||-0.05|-4.12|0.045
74020857|NCT01256177|147594419|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.22|STANDARD_ERROR_OF_MEAN|1.1||0.004|TWO_SIDED|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)||-1.04|-5.39|0.004
74020858|NCT01256177|147594420|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.24|STANDARD_ERROR_OF_MEAN|0.83||0.007|TWO_SIDED|95.0|-3.88|-0.61|||Mixed Model Repeated Measures (MMRM)|Baseline HAM-D total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in HAM-D total score based on observed cases (OC)||-0.61|-3.88|0.007
74080994|NCT02997176|147713973|OTHER|Bioequivalence|Percent Ratio of Geometric Means|94.58|||||TWO_SIDED|90.0|56.74|157.64||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||157.64|56.74|
73836824|NCT01026038|147222734|SUPERIORITY_OR_OTHER||GMC ratio|0.48|||||TWO_SIDED|95.0|0.26|0.89||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.89|0.26|
74020859|NCT01256177|147594421|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.51|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.84|-0.17|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for overall BP illness as covariate, trt, bipolar strata, visit, trt-visit interaction as fixed effect and centre as random.||Change from baseline to Week 8 assessment in the CGI-BP-S score for overall Bipolar (BP) illness based on observed cases (OC)||-0.17|-0.84|0.003
74020860|NCT01256177|147594421|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.47|STANDARD_ERROR_OF_MEAN|0.17||0.007|TWO_SIDED|95.0|-0.81|-0.13|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for depression as covariate, trt, Bipolar strata, visit, trt-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 assessment in the CGI-BP-S score of depression based on observed cases (OC)||-0.13|-0.81|0.007
74020861|NCT01256177|147594422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.004|TWO_SIDED|95.0|1.26|3.36|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, baseline score and bipolar Strata.|Quetiapine XR/Placebo|||3.36|1.26|0.004
74020862|NCT01256177|147594423|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.005|TWO_SIDED|95.0|-0.38|-0.07|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS item 10 score as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effect and centre as random.||Change from Baseline to Week 8 in MADRS item 10 score for suicidal ideation based on observed cases (OC)||-0.07|-0.38|0.005
74020863|NCT01256177|147594424|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||0.233|TWO_SIDED|95.0|0.03|2.38|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, strata and baseline score.|Quetiapine XR/Placebo|||2.38|0.03|0.233
74020864|NCT01110395|147594425|OTHER|Bland and Altman|Mean + SD|0.05|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|||||Bland Altman|mean + SD|Bland Altman|We have provided all the information that is available to us. The PI has left the institution and we are unable to contact him. We have no further data to correct the errors.|We are unable to provide any further data that has been requested. We have supplied all the data that we can possibly provide because the PI has left the institution and we are unable to contact him. We have no other data.|There are no other statistical analysis. We have provided all the information that is available to us. We have no other data available to us because the PI has left the institution and we are unable to contact him.|||
73836825|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT Ratio|0.2|||||TWO_SIDED|95.0|0.04|0.73||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.73|0.04|
74020865|NCT01110395|147594425|OTHER||||||<|0.05|||||||Mean + SD|||||||<0.05
74020866|NCT01111305|147594426|EQUIVALENCE|Equivalence is defined as p≥0.05||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
74020867|NCT00331006|147594438|SUPERIORITY_OR_OTHER||Proportion|0.1875||||0.043|ONE_SIDED|95.0|0.053|||the a priori p-value was 0.05 for statistical significance|Exact Binomial|||The null hypothesis is that the proportion of participants in which the inhibitor level falls to less than 5 BU/mL between weeks 6 to 22 and remains below 5 BU/mL at 5-7 days following re-challenge with factor VIII is no more than 0.05|||.053|0.043
74020868|NCT00331006|147594439|SUPERIORITY_OR_OTHER||Proportion|0.25|||||TWO_SIDED|95.0|0.073|0.524|||Exact Binomial|||No hypothesis about the value of this proportion was specified in the study design||0.524|0.073|
74020869|NCT01950819|147594446|NON_INFERIORITY|p vale for non inferiority margin is 10 %|Odds Ratio (OR)|3.0||||0.001|TWO_SIDED|95.0|-1.4|7.3|||Logistic Regression Model|||calculated at month 12||7.3|-1.4|0.001
74020870|NCT02928952|147594477|SUPERIORITY|Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.153|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.153
74020871|NCT02928952|147594477|SUPERIORITY|Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.026|||||||Mixed Models Analysis|Adjusted for age and duration of diabetes.||||||0.026
74020872|NCT02928952|147594477|SUPERIORITY|Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.012|||||||Mixed Models Analysis|Models adjusted for age and duration of diabetes.||Within group analysis of intervention effect on Diabetes Distress (Problem Areas in Diabetes, PAID scale) over time stratified by hemoglobin A1c\<8.5% and =/\>8.5.||||0.012
74020873|NCT02928952|147594478|SUPERIORITY|The statistical analysis was applied to both groups.||||||0.604|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||.604
74020874|NCT02928952|147594479|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.911|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.911
74020875|NCT02928952|147594480|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.94|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||||||0.940
74020876|NCT02928952|147594481|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.305|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.305
74020877|NCT02928952|147594482|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.228|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||||||0.228
74020878|NCT02928952|147594483|SUPERIORITY|Statistical Test of hypothesis. Differing sample sizes are due to attrition and missed research visits. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.671|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.671
74020879|NCT02928952|147594484|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.571|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.571
74020880|NCT02928952|147594485|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.003|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.003
74020881|NCT02928952|147594486|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.632|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.632
74020882|NCT02928952|147594487|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.219|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.219
74080995|NCT02997176|147713973|OTHER|Bioequivalence|Percent Ratio of Geometric Means|92.15|||||TWO_SIDED|90.0|51.69|164.26||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||164.26|51.69|
74020883|NCT02928952|147594488|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.931|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.931
74020884|NCT02928952|147594489|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.627|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.627
74020885|NCT02928952|147594490|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.6|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.60
74020886|NCT02928952|147594491|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.461|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.461
74020887|NCT02928952|147594492|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.906|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.906
74080996|NCT02997176|147713973|OTHER|Bioequivalence|Percent Ratio of Geometric Means|84.42|||||TWO_SIDED|90.0|53.14|134.1||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||134.10|53.14|
74020888|NCT02928952|147594493|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.856|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.856
74020889|NCT02928952|147594494|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.89|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.89
74020890|NCT00723957|147594495|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04|||||ONE_SIDED|90.0||1.41|||Regression, Cox|||||1.41||
74020891|NCT00723957|147594495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5735|||||||Log Rank|||P-value is 1-sided||||0.5735
74020892|NCT00723957|147594496|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||ONE_SIDED|90.0||1.1|||Regression, Cox|||||1.10||
74020893|NCT00723957|147594496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||Log Rank|||P-value is 1-sided||||0.1750
74020894|NCT00723957|147594497|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||||ONE_SIDED|90.0||1.15|||Regression, Cox|||||1.15||
74020895|NCT00723957|147594497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.316|ONE_SIDED||||||Log Rank|||P-value is 1-sided||||0.316
74020896|NCT00723957|147594503|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||ONE_SIDED|90.0||2.1|||Regression, Cox||β3T+ subgroup|||2.10||
73836826|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT Ratio|0.2|||||TWO_SIDED|95.0|0.04|0.64||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.64|0.04|
74020897|NCT00723957|147594503|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||ONE_SIDED|90.0||0.9|||Regression, Cox||β3T- subgroup|||0.90||
74020898|NCT00723957|147594503|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||ONE_SIDED|90.0||1.4|||Regression, Cox||Overall population|||1.40||
74020899|NCT01850615|147594506|SUPERIORITY_OR_OTHER||Treatment difference|-0.94|||||TWO_SIDED|95.0|-1.17|-0.72|||||Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval (CI) for the estimated treatment difference (faster aspart+basal minus basal only), which was calculated using the FAS, was below 0%.|Change from baseline in HbA1c after 18 weeks of treatment was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits 16, 22 and 28 were included in the analysis. This model included treatment, region and strata as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||-0.72|-1.17|
74020900|NCT00706628|147594512|SUPERIORITY_OR_OTHER|||||||0.0577|||||||Fisher Exact|||||||0.0577
74020901|NCT00706628|147594512|SUPERIORITY_OR_OTHER|||||||0.0863|||||||Fisher Exact|||||||0.0863
74020902|NCT00706628|147594514|SUPERIORITY_OR_OTHER||Slope|1.4823|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|1.1754|1.7892||||||||1.7892|1.1754|
74020903|NCT01375764|147594615|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.94|STANDARD_ERROR_OF_MEAN|4.11|<|0.001|TWO_SIDED|95.0|-44.08|-27.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-27.80|-44.08|<0.001
74020904|NCT01375764|147594615|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.82|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-35.97|-19.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-19.67|-35.97|<0.001
74020905|NCT01375764|147594615|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Tretament Difference|-26.01|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-34.08|-17.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-17.93|-34.08|<0.001
74020906|NCT01375764|147594616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.29|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED|95.0|-53.73|-40.84||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab + ezetimibe and ezetimibe alone, and the alternative hypothesis was that a mean difference did exist.||-40.84|-53.73|<0.001
74020907|NCT01375764|147594617|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-76.6|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-94.9|-58.3||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-58.3|-94.9|<0.001
74020908|NCT01375764|147594617|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.5|STANDARD_ERROR_OF_MEAN|9.3|<|0.001|TWO_SIDED|95.0|-74.0|-37.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-37.1|-74.0|<0.001
74020909|NCT01375764|147594617|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.6|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-70.8|-34.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-34.5|-70.8|<0.001
74020910|NCT01375764|147594618|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-91.9|STANDARD_ERROR_OF_MEAN|8.4|<|1|TWO_SIDED|95.0|-108.7|-75.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-75.0|-108.7|<0001
74020911|NCT01375764|147594619|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.6|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-40.93|-26.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-26.28|-40.93|<0.001
74020912|NCT01375764|147594619|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.66|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-33.99|-19.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-19.32|-33.99|<0.001
74020913|NCT01375764|147594619|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-24.86|STANDARD_ERROR_OF_MEAN|3.67|<|0.001|TWO_SIDED|95.0|-32.13|-17.59||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-17.59|-32.13|<0.001
74020914|NCT01375764|147594620|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.0|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-50.81|-39.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-39.18|-50.81|<0.001
74020915|NCT01375764|147594621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Teatment Difference|-29.88|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-36.84|-22.92||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-22.92|-36.84|<0.001
74020916|NCT01375764|147594621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.13|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-29.1|-15.16||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-15.16|-29.10|<0.001
74020917|NCT01375764|147594621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.38|STANDARD_ERROR_OF_MEAN|3.49|<|0.001|TWO_SIDED|95.0|-28.29|-14.48||Testing based on a signficance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-14.48|-28.29|<0.001
74020918|NCT01375764|147594622|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.23|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-43.81|-32.64||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-32.64|-43.81|<0.001
74020919|NCT01375764|147594623|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.95|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-37.56|-24.34||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-24.34|-37.56|<0.001
74080997|NCT00373256|147714020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6299||||0.9986|TWO_SIDED|95.0|1.1793|2.2527||p-value from 1-sided log-rank stratified for prior adjuvant chemotherapy, hormone receptor status, disease-free interval from prior adjuvant treatment. Stratification factors from Interactive Voice Randomization System.|Log Rank||Assuming proportional hazards, a hazard ratio greater than 1 indicated a reduction in hazard rate in favor Bevacizumab + Paclitaxel.|||2.2527|1.1793|0.9986
74080998|NCT00373256|147714021|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|32.2|||||TWO_SIDED|95.0|26.4|38.5||||||||38.5|26.4|
74080999|NCT00373256|147714021|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|32.1|||||TWO_SIDED|95.0|26.3|38.4||||||||38.4|26.3|
74020920|NCT01375764|147594623|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.91|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-30.53|-17.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-17.29|-30.53|<0.001
74020921|NCT01375764|147594623|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.36|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-28.92|-15.8||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-15.80|-28.92|<0.001
74020922|NCT01375764|147594624|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.92|STANDARD_ERROR_OF_MEAN|2.92|<|0.001|TWO_SIDED|95.0|-43.77|-32.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-32.07|-43.77|<0.001
74020923|NCT01375764|147594625|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.05|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-40.57|-27.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-27.52|-40.57|<0.001
74020924|NCT01375764|147594625|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-33.35|-20.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-20.27|-33.35|<0.001
74081000|NCT00373256|147714024|SUPERIORITY_OR_OTHER||Percentage|76.8|||||TWO_SIDED|95.0|68.7|83.0||||||1 year||83.0|68.7|
74081001|NCT00373256|147714024|SUPERIORITY_OR_OTHER||Percentage|35.5|||||TWO_SIDED|95.0|20.9|50.3||||||2 years||50.3|20.9|
74081002|NCT00373256|147714024|SUPERIORITY_OR_OTHER||Percentage|83.7|||||TWO_SIDED|95.0|76.0|89.1||||||1 year||89.1|76.0|
74081003|NCT00373256|147714024|SUPERIORITY_OR_OTHER||Percentage|61.0|||||TWO_SIDED|95.0|43.2|74.7||||||2 years||74.7|43.2|
74081004|NCT02645253|147714045|SUPERIORITY_OR_OTHER||Slope|1.02|STANDARD_ERROR_OF_MEAN|0.0785|||TWO_SIDED|90.0|0.882|1.15|||Linear Model|||||1.15|0.882|
74020925|NCT01375764|147594625|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.1|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|-31.57|-18.62||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-18.62|-31.57|<0.001
74020926|NCT01375764|147594626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.25|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-46.99|-35.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-35.50|-46.99|<0.001
74020927|NCT01194440|147594634|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Bonferonni|Adjusting for multiple comparisons in the analyses, a Bonferonni-corrected p-value of 0.05/5 = 0.01 to represent statistical significance was used.||The primary hypothesis of the study is that administration of zoledronic acid with letrozole would result in a significant decline in the percentage of women experiencing AIMSS compared to letrozole treatment alone (historical control).||||<0.001
74020928|NCT00854828|147594638|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74020929|NCT00896532|147594648|SUPERIORITY||LS Mean Difference from Placebo|8.7|||<|0.0001|TWO_SIDED|95.0|7.5|9.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||9.9|7.5|< 0.0001
74020930|NCT00896532|147594648|SUPERIORITY||LS Mean Difference from placebo|5.6|||<|0.0001|TWO_SIDED|95.0|4.3|6.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||6.9|4.3|< 0.0001
74020931|NCT00896532|147594648|SUPERIORITY||LS Mean Difference from Placebo|7.4|||<|0.0001|TWO_SIDED|95.0|6.1|8.7||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||8.7|6.1|< 0.0001
74020932|NCT00896532|147594648|SUPERIORITY||LS Mean Difference from Placebo|8.5|||<|0.0001|TWO_SIDED|95.0|7.3|9.8||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||9.8|7.3|< 0.0001
74020933|NCT02149810|147594659|SUPERIORITY||Mean Difference (Net)|0.109||||0.28|TWO_SIDED|95.0|-0.09|0.31||The a priori threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on SDNN.||The primary focus of this study was the interaction effect of treatment on heart rate variability at Weeks 0 and 12. On the assumption that this effect size is medium (Cohen's f = .25), calculations (using G\*Power) 23 indicate that a sample size of 80 yield power estimates of .99 for both the interaction and the main effect of time. The study enrolled 95 participants to account for participant attrition.||0.31|-0.09|0.28
74020934|NCT02149810|147594660|SUPERIORITY||Mean Difference (Net)|0.034||||0.89|TWO_SIDED|95.0|-0.44|0.51||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on LF HRV.||||0.51|-0.44|0.89
74020935|NCT02149810|147594661|SUPERIORITY||Mean Difference (Net)|-2.66||||0.03|TWO_SIDED|95.0|-5.05|-0.26||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.26|-5.05|0.030
74020936|NCT02149810|147594662|SUPERIORITY||Mean Difference (Net)|-2.37||||0.021|TWO_SIDED|95.0|-4.37|-0.36||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.36|-4.37|0.021
74081005|NCT02645253|147714047|SUPERIORITY_OR_OTHER||Slope|1.14|STANDARD_ERROR_OF_MEAN|0.0503|||TWO_SIDED|90.0|1.06|1.23|||Linear Model|||||1.23|1.06|
74020937|NCT02149810|147594663|SUPERIORITY||Mean Difference (Net)|11.0||||0.22|TWO_SIDED|95.0|-7.01|29.01||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||29.01|-7.01|0.22
74020938|NCT02149810|147594664|SUPERIORITY||Mean Difference (Net)|1.91||||0.72|TWO_SIDED|95.0|-8.54|12.37||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||12.37|-8.54|0.72
74020939|NCT02149810|147594665|SUPERIORITY||Mean Difference (Net)|-0.8||||0.018|TWO_SIDED|95.0|-1.46|-0.15||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.15|-1.46|0.018
74020940|NCT02149810|147594666|SUPERIORITY||Mean Difference (Net)|-0.14||||0.99|TWO_SIDED|95.0|-21.94|21.66||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||21.66|-21.94|0.99
74081006|NCT02645253|147714049|SUPERIORITY_OR_OTHER||Slope|1.05|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|90.0|0.801|1.31|||Linear Model|||||1.31|0.801|
74081007|NCT02645253|147714059|SUPERIORITY_OR_OTHER||Slope|0.979|STANDARD_ERROR_OF_MEAN|0.0633|||TWO_SIDED|90.0|0.87|1.09|||Linear Model|||||1.09|0.870|
74081008|NCT02645253|147714064|SUPERIORITY_OR_OTHER||Slope|1.05|STANDARD_ERROR_OF_MEAN|0.0552|||TWO_SIDED|90.0|0.951|1.14|||Linear Model|||||1.14|0.951|
74081009|NCT02645253|147714076|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|102.99|||||TWO_SIDED|95.0|86.88|122.09|||ANCOVA||Day 1/ Day -1|||122.09|86.88|
74081010|NCT02645253|147714076|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|91.82|||||TWO_SIDED|95.0|77.32|109.04|||ANCOVA||Day 16 / Day -1|||109.04|77.32|
74081011|NCT02645253|147714076|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|105.92|||||TWO_SIDED|95.0|89.4|125.49|||ANCOVA||Day 1 / Day -1|||125.49|89.40|
74020941|NCT02149810|147594667|SUPERIORITY||Odds Ratio (OR)|3.26||||0.049|TWO_SIDED|95.0|1.01|10.53||The a priori threshold for statistical significance was set at p = 0.05.|Regression, Linear|||Generalised linear models were used to compare the proportion of participants who responded to the intervention (≥50% decrease from baseline on the HRSD, defined a priori) at the end of intervention (week 12).||10.53|1.01|0.049
74020942|NCT02149810|147594668|SUPERIORITY||Odds Ratio (OR)|3.36||||0.04|TWO_SIDED|95.0|1.06|10.64||The a priori threshold for statistical significance was set at p = 0.05.|Regression, Linear|||Generalised linear models were used to compare the proportion of the proportion of participants who achieved remission (scores ≤7 on the HRSD, defined a priori) at the end of intervention (week 12).||10.64|1.06|0.040
74020943|NCT03158220|147594676|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.77||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 16||0.77|0.63|< 0.001
74020944|NCT03158220|147594676|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.8||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 18||0.80|0.64|< 0.001
74020945|NCT03158220|147594676|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.66|||<|0.001|TWO_SIDED|95.0|0.6|0.74||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 31||0.74|0.60|< 0.001
74020946|NCT03158220|147594676|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.8||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 33||0.80|0.67|< 0.001
74020947|NCT03158220|147594676|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.6|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 45||0.76|0.60|< 0.001
74020948|NCT03158220|147594676|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.78||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 52||0.78|0.64|< 0.001
74020949|NCT03158220|147594676|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.63|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 58||0.76|0.63|< 0.001
74020950|NCT03158220|147594679|OTHER||Difference in Percentages|-2.5||||0.212|TWO_SIDED|95.0|-6.4|1.4|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||1.4|-6.4|0.212
74020951|NCT03158220|147594680|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-7.3|3.4|||||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||3.4|-7.3|
74020952|NCT03158220|147594681|OTHER||Difference in Percentages|-1.0||||0.3|TWO_SIDED|95.0|-3.1|0.9|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||0.9|-3.1|0.300
74020953|NCT01015833|147594683|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.24|TWO_SIDED|95.0|0.8|1.4|||t-test, 1 sided|||||1.4|0.8|0.24
74020954|NCT01015833|147594685|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.98|TWO_SIDED|95.0|0.72|1.2|||t-test, 1 sided|||||1.2|0.72|0.98
74020955|NCT02730260|147594711|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||Test of the null hypothesis that directive and nondirective coaching have equal smoking cessation rates.||||0.41
74020956|NCT02730260|147594711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||<|0.03|TWO_SIDED||||||Regression, Logistic|||Odds ratio based on the parameter estimate for the variable, IncomeAboveMedian (0=false, 1=true), from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. An unbalanced variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model.||||<0.03
74020957|NCT02730260|147594711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.03|TWO_SIDED||||||Regression, Logistic|||Odds ratio for PriorQuit, from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. This variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model because it was not balanced after randomization.||||<0.03
74081012|NCT02645253|147714076|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|89.44|||||TWO_SIDED|95.0|75.35|106.16|||ANCOVA||Day 16 / Day -1|||106.16|75.35|
74081013|NCT02645253|147714076|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|99.82|||||TWO_SIDED|95.0|84.12|118.46|||ANCOVA||Day 1 / Day -1|||118.46|84.12|
74081014|NCT02645253|147714076|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|75.38||||||95.0|63.4|89.61|||ANCOVA||Day 16 / Day -1|||89.61|63.40|
73898151|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74020958|NCT05032950|147594742|OTHER||Reference/Test Ratio|368.33|||||TWO_SIDED|90.0|318.91|425.41|||Mixed Models Analysis|||Natural log-transformed Cmax of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||425.41|318.91|
74020959|NCT05032950|147594743|OTHER||Reference/Test Ratio|1430.02|||||TWO_SIDED|90.0|1204.54|1697.71|||Mixed Models Analysis|||Natural log-transformed AUCinf of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1697.71|1204.54|
74020960|NCT05032950|147594744|OTHER||Test/Reference Ratio|1451.78|||||TWO_SIDED|90.0|1224.42|1721.35|||Mixed Models Analysis|||Natural log-transformed AUClast of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1721.35|1224.42|
74020961|NCT05032950|147594749|OTHER||Test/Reference Ratio|387.2|||||TWO_SIDED|90.0|335.25|447.21|||Mixed Models Analysis|||Natural log-transformed Cmax of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||447.21|335.25|
74020962|NCT05032950|147594750|OTHER||Test/Reference Ratio|1645.15|||||TWO_SIDED|90.0|1385.75|1953.11|||Mixed Models Analysis|||Natural log-transformed AUCinf of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios||1953.11|1385.75|
74020963|NCT05032950|147594751|OTHER||Test/Reference Ratio|1677.25|||||TWO_SIDED|90.0|1414.59|1988.69|||Mixed Models Analysis|||Natural log-transformed AUClast of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1988.69|1414.59|
74020964|NCT02078219|147594810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.28|||<|0.0001|TWO_SIDED|95.0|-36.99|-21.57|||ANCOVA, LOCF|||||-21.57|-36.99|<0.0001
74020965|NCT02078219|147594810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.25|||<|0.0001|TWO_SIDED|95.0|-56.97|-41.52|||ANCOVA, LOCF|||||-41.52|-56.97|<0.0001
74020966|NCT02078219|147594810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.33|||<|0.0001|TWO_SIDED|95.0|-61.0|-45.67|||ANCOVA, LOCF|||||-45.67|-61.00|<0.0001
74020967|NCT05148884|147594861|OTHER|||||||0.0016|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.0016
74020968|NCT05148884|147594861|OTHER|||||||0.6886|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.6886
74081015|NCT02727192|147714080|SUPERIORITY||Mean Difference (Net)|-0.6||||0.52|TWO_SIDED|95.0|-2.6|1.3||A two-sided significance level of 5% was considered to indicate statistical significance.|Regression, Linear|||||1.3|-2.6|0.520
74081016|NCT02727192|147714081|SUPERIORITY||Mean Difference (Net)|-0.9||||0.44|TWO_SIDED|95.0|-3.3|1.5|||Regression, Linear|||||1.5|-3.3|0.440
74020969|NCT05148884|147594862|OTHER|||||||0.0281|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.0281
74020970|NCT05148884|147594862|OTHER|||||||0.7953|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.7953
74020971|NCT02300129|147594889|SUPERIORITY_OR_OTHER|||||||0.742|TWO_SIDED|||||P value associated to treatment effect in the model. Study design with a power of 80% and a type I error at 5% (two-sided).|ANOVA|Analysis of variance including sequence, subject (sequence), period and treatment as factors in the model||||||0.7420
74020972|NCT00522392|147594918|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||Log Rank|||Stratified log rank test was used to compare progression-free survival between the two arms.||||0.092
74020973|NCT00522392|147594919|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Fisher's exact test was used to compare the response rates between the two arms.||||0.029
74020974|NCT00522392|147594920|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Log Rank|||Stratified log-rank test was used to compare overall survival between the two arms.||||0.48
74081017|NCT02727192|147714082|SUPERIORITY||Mean Difference (Net)|-0.6||||0.41|TWO_SIDED|95.0|-2.1|0.9|||Regression, Linear|||||0.9|-2.1|0.410
74081018|NCT02727192|147714083|SUPERIORITY||Difference in Percentage of Participants|-9.3||||0.33|TWO_SIDED||||||Chi-squared|||||||0.33
74081019|NCT02727192|147714086|SUPERIORITY||Mean Difference (Net)|2.8||||0.058|TWO_SIDED|95.0|-0.1|5.8|||Regression, Linear|||Mental Component Summary score||5.8|-0.1|0.058
74020975|NCT03051633|147594930|SUPERIORITY|Event: Dichotimized self-reported first-time alcohol use in known participant history prior to data-collection, where substance use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If substance use was reported, censoring indicator indicates the risk period|Hazard Ratio (HR)|-0.42||||0.004|TWO_SIDED|95.0|-0.714|-0.126|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time alcohol use during a given measurement period, given that students did not use alchohol in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake by the end of their eighth-grade year, relative to students attending control schools.||-0.126|-0.714|.004
74020976|NCT03051633|147594931|SUPERIORITY|Event: dichotimized self-reported first-time alcohol intoxication in known participant history prior to data collection, where intoxication was not reported in prior measurement occasions. Episodes: Represent the period of time between measurement occasions, thus, each episode represents the measured period of time between each assessment wave. Censoring: Indicates the risk period during which particpants experienced intoxication uptake.|Hazard Ratio, log|-0.39||||0.037|TWO_SIDED|95.0|-0.762|-0.018|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ration rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time alcohol initiation during a given measurement period, given that students did not become intoxicated in a previous measurement period. Thus, for each model, we tested the following hypothesis: controlling for age at first assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake at the end of their eight grade year||-0.018|-0.762|.037
74020977|NCT03051633|147594932|SUPERIORITY|Event: Dichotimized self-reported first-time marijuana use in known participant history prior to data-collection, where marijuana use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If marijuana use was reported, censoring indicator indicates the risk period.|Hazard Ratio, log|0.17||||0.228|TWO_SIDED|95.0|-0.104|0.444|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time marijuana use during a given measurement period, given that students did not use marijuana in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of marijuana use uptake by the end of their eighth-grade year, relative to students attending control schools.||0.444|-0.104|0.228
74020978|NCT03575104|147594957|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-11.62||||0.0001|TWO_SIDED|95.0|-17.604|-5.633||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.025; statistically significant = YES||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 25 mg vs placebo).||-5.633|-17.604|0.0001
74020979|NCT03575104|147594957|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-2.74||||0.3669|TWO_SIDED|95.0|-8.693|3.215||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00977; statistically significant = NO||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 10 mg vs placebo).||3.215|-8.693|0.3669
74020980|NCT03575104|147594958|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS Mean difference to placebo|-10.25||||0.0028|TWO_SIDED|95.0|-16.95|-3.548||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.01563; statistically significant = YES||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 25 mg vs placebo).||-3.548|-16.95|0.0028
74020981|NCT03575104|147594958|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS Mean difference to placebo|-1.95||||0.5686|TWO_SIDED|95.0|-8.666|4.764||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 10 mg vs placebo).||4.764|-8.666|0.5686
74020982|NCT03575104|147594959|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-6.45||||0.0303|TWO_SIDED|95.0|-12.282|-0.614||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.025; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||-0.614|-12.282|0.0303
74020983|NCT03575104|147594959|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-2.61||||0.3782|TWO_SIDED|95.0|-8.41|3.197||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00195; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).||3.197|-8.41|0.3782
74020984|NCT03575104|147594960|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-9.01||||0.0053|TWO_SIDED|95.0|-15.339|-2.684||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00313; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||-2.684|-15.339|0.0053
74020985|NCT03575104|147594960|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-3.19||||0.3233|TWO_SIDED|95.0|-9.528|3.146||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).||3.146|-9.528|0.3233
74020986|NCT03575104|147594961|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|16.13|||<|0.0001|TWO_SIDED|95.0|8.224|24.035||Hypothesis testing result: threshold for significance p = 0.0125; statistically significant = YES|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||24.035|8.224|<.0001
74020987|NCT03575104|147594961|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|13.37|||=|0.0009|TWO_SIDED|95.0|5.507|21.226||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 10 mg vs placebo).||21.226|5.507|= 0.0009
74020988|NCT03575104|147594962|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|19.06|||<|0.0001|TWO_SIDED|95.0|10.125|27.994||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00781; statistically significant = YES||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 25 mg vs placebo).||27.994|10.125|<.0001
74081020|NCT02727192|147714086|SUPERIORITY||Mean Difference (Net)|-2.1||||0.16|TWO_SIDED|95.0|-5.1|0.8|||Regression, Linear|||Physical Component Summary score||0.8|-5.1|0.160
74081021|NCT02727192|147714087|SUPERIORITY||Mean Difference (Net)|-0.9||||0.11|TWO_SIDED|95.0|-2.0|0.2|||Regression, Linear|||||0.2|-2.0|0.110
74081022|NCT02727192|147714089|SUPERIORITY||Mean Difference (Net)|0.1||||0.85|TWO_SIDED|95.0|-0.5|0.6|||Regression, Linear|||||0.6|-0.5|0.850
74081023|NCT02727192|147714091|SUPERIORITY||Median Difference (Net)|0.3||||0.65|TWO_SIDED|95.0|-1.0|1.6|||Regression, Linear|||||1.6|-1.0|0.650
74020989|NCT03575104|147594962|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|13.58|||=|0.0028|TWO_SIDED|95.0|4.691|22.475||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 10 mg vs placebo).||22.475|4.691|= 0.0028
74020990|NCT03575104|147594963|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.75|||=|0.0733|TWO_SIDED|95.0|-1.581|0.071||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00625; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 25 mg vs placebo).||0.071|-1.581|= 0.0733
74020991|NCT03575104|147594963|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.43|||=|0.3048|TWO_SIDED|95.0|-1.251|0.392||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 10 mg vs placebo).||0.392|-1.251|= 0.3048
74020992|NCT03575104|147594964|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-1.25|||=|0.012|TWO_SIDED|95.0|-2.23|-0.276||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00391; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 25 mg vs placebo).||-0.276|-2.230|= 0.0120
74020993|NCT03575104|147594964|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.73|||=|0.1393|TWO_SIDED|95.0|-1.706|0.239||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 10 mg vs placebo).||0.239|-1.706|= 0.1393
74020994|NCT03575104|147594965|OTHER||LS mean difference to placebo|0.93||||0.2506|TWO_SIDED|95.0|0.82|1.05||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).||1.05|0.82|0.2506
74020995|NCT03575104|147594965|OTHER||LS mean difference to placebo|0.8||||0.0004|TWO_SIDED|95.0|0.71|0.91||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||0.91|0.71|0.0004
74020996|NCT03575104|147594966|OTHER||LS mean difference to placebo|0.96||||0.5037|TWO_SIDED|95.0|0.84|1.09||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).||1.09|0.84|0.5037
74020997|NCT03575104|147594966|OTHER||LS mean difference to placebo|0.81||||0.0021|TWO_SIDED|95.0|0.71|0.93||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||0.93|0.71|0.0021
74081024|NCT02727192|147714092|SUPERIORITY||Mean Difference (Net)|2.6||||0.006|TWO_SIDED|95.0|0.8|4.5|||Regression, Linear|||||4.5|0.8|0.006
74081025|NCT02727192|147714093|SUPERIORITY||Median Difference (Net)|-31.4||||0.389|TWO_SIDED|95.0|-103.4|40.7|||Regression, Linear|||||40.7|-103.4|0.389
74081026|NCT02727192|147714096|SUPERIORITY||Mean Difference (Net)|0.1||||0.697|TWO_SIDED|95.0|-0.3|0.5|||Regression, Logistic|||||0.5|-0.3|0.697
74020998|NCT00624520|147595013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|891.0||||0.18|TWO_SIDED|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."||||0.18
74081027|NCT00928057|147714098|NON_INFERIORITY_OR_EQUIVALENCE|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.506||||||The threshold for statistical significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using analysis of variance (ANOVA). The ANOVA model was used to calculate the absolute percent (%)change in fructosamine (% \|∆ Fru\|), with 95 % confidence intervals."||||0.506
74020999|NCT00624520|147595014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
74021000|NCT00624520|147595015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.003|TWO_SIDED||||||ANOVA|||||||0.003
74021001|NCT00624520|147595016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.011|TWO_SIDED||||||ANOVA|||||||0.011
74021002|NCT00624520|147595017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.048|TWO_SIDED||||||ANOVA|||||||0.048
74021003|NCT00624520|147595018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
74021004|NCT00624520|147595019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
74021005|NCT00624520|147595020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
74021006|NCT00624520|147595021|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Fisher Exact|||||||0.21
74021007|NCT00624520|147595022|SUPERIORITY_OR_OTHER||Effect size (Cohen's d)|0.38||||0.025|TWO_SIDED|||||P-value refers to a repeated measures within-group comparison in the CBSM group using ANCOVA with baseline DP elevation as covariate from baseline to 3 months post.|ANCOVA||Range of Cohen's d for small effect is 0.20 - 0.50|||||0.025
74021008|NCT00624520|147595023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|80.0||||0.81|TWO_SIDED|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."||||0.81
74021009|NCT01925209|147595024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.59|STANDARD_ERROR_OF_MEAN|14.331||0.221|TWO_SIDED|99.0|-19.63|54.8|||mixed model repeated measures|||||54.80|-19.63|0.2210
74021010|NCT01925209|147595024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.59|STANDARD_ERROR_OF_MEAN|14.176||0.1909|TWO_SIDED|99.0|-18.21|55.4|||mixed model repeated measure|||||55.40|-18.21|0.1909
74021011|NCT01925209|147595024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.31|STANDARD_ERROR_OF_MEAN|14.121||0.9263|TWO_SIDED|99.0|-37.97|35.36|||mixed models repeated measures|||||35.36|-37.97|0.9263
74021012|NCT04398732|147595043|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from Baseline in percent BSA at Month 12.||||0.0001
74081028|NCT00928057|147714098|NON_INFERIORITY_OR_EQUIVALENCE|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.878||||||The threshold for significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using ANOVA. The ANOVA model was used to calculate the % \|∆ Fru\|, with 95% confidence intervals."||||0.878
74021013|NCT04398732|147595044|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in DLQI at Month 12.||||0.0001
74021014|NCT04398732|147595045|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in PASI at Month 12.||||0.0001
74021015|NCT04398732|147595046|OTHER|||||||0.036|||||||Student's t-test|||Baseline||||0.036
74021016|NCT04398732|147595046|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
74021017|NCT04398732|147595046|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
74021018|NCT04398732|147595047|OTHER|||||||0.42|||||||Student's t-test|||Baseline||||0.42
74021019|NCT04398732|147595047|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
74021020|NCT04398732|147595047|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
74021021|NCT04398732|147595048|OTHER|||||||0.72|||||||Student's t-test|||Baseline||||0.72
74021022|NCT04398732|147595048|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
74021023|NCT04398732|147595048|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
74021024|NCT04398732|147595049|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from Baseline in percent BSA at Month 4.||||0.0001
74021025|NCT04398732|147595050|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in DLQI at Month 4.||||0.0001
74021026|NCT04398732|147595051|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in PASI at Month 4.||||0.0001
74021027|NCT05617521|147595067|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients||||||0.008||||||The comparative analysis of the CIT was previously subjected to normality evaluation by the Shapiro-Wilk test. According to the rejection of normal distribution, comparative data analysis has been performed with a two-way Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||||||0.008
74021028|NCT05617521|147595068|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients.|||||<|0.001||||||For the comparison of abdominal pressure, Pearson chi-square test was used. The statistical significance level was accepted as p \<0.05|Chi-squared|||||||<0.001
74021029|NCT05617521|147595069|SUPERIORITY||||||<|0.001||||||The comparative analysis of the CIL was previously subjected to normality evaluation by the Shapiro-Wilk test. According to the rejection of normal distribution, comparative data analysis has been performed with a two-way Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||||||<0.001
74021030|NCT05617521|147595070|SUPERIORITY|||||||0.321|||||||Chi-squared|||||||0.321
74021031|NCT05617521|147595071|SUPERIORITY|||||||0.75|||||||Fisher Exact|||||||0.75
74021032|NCT05617521|147595072|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.005
74021033|NCT05617521|147595073|OTHER|||||||0.8|||||||Fisher Exact|||||||0.8
74021034|NCT05617521|147595075|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
74021035|NCT05617521|147595076|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74021036|NCT05617521|147595077|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74081029|NCT00928057|147714103|SUPERIORITY_OR_OTHER|||||||0.019||||||The threshold for statistical significance, or alpha, is 0.05.|t-test, 1 sided|||The null hypothesis is that the pain from the 4mm is the same or greater than the pain for the reference. The alternative hypothesis is that the pain from the 4mm is less than the pain for the reference.||||0.019
73898152|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.063||0.898|TWO_SIDED|95.0|-0.132|0.116||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.116|-0.132|0.898
74021037|NCT05617521|147595078|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients.||||||0.01||||||For the comparison of position change, Pearson chi-square test was used. The statistical significance level was accepted as p \<0.05|Chi-squared|||||||0.01
74021038|NCT05617521|147595079|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
74021039|NCT02304926|147595097|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021040|NCT02304926|147595098|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021041|NCT02304926|147595099|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021042|NCT02304926|147595100|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74021043|NCT02304926|147595101|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74021044|NCT02304926|147595102|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021045|NCT02304926|147595103|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021046|NCT02304926|147595104|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021047|NCT02304926|147595105|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021048|NCT02304926|147595106|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021049|NCT02304926|147595107|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021050|NCT02304926|147595108|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021051|NCT02304926|147595109|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021052|NCT02304926|147595110|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021053|NCT02304926|147595111|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021054|NCT02304926|147595112|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021055|NCT02304926|147595113|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021056|NCT02304926|147595114|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74021057|NCT02304926|147595115|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021058|NCT02304926|147595116|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74021059|NCT00792298|147595119|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|12.9|||<|0.001|TWO_SIDED|95.0|9.5|16.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||16.3|9.5|<0.001
74021060|NCT00792298|147595119|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|7.6|||<|0.001|TWO_SIDED|95.0|4.4|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||10.9|4.4|<0.001
74021061|NCT00792298|147595119|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|10.8|||<|0.001|TWO_SIDED|95.0|7.4|14.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||14.2|7.4|<0.001
74081030|NCT00928057|147714103|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||As described for the 4 vs. 5mm statistical analysis.||||<0.001
74021062|NCT00792298|147595119|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|7.8|||<|0.001|TWO_SIDED|95.0|4.6|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||10.9|4.6|<0.001
74021063|NCT00792298|147595119|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|7.6|||<|0.001|TWO_SIDED|95.0|4.2|11.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||11.0|4.2|<0.001
74021064|NCT00792298|147595119|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|10.4|||<|0.001|TWO_SIDED|95.0|7.2|13.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||13.6|7.2|<0.001
74021065|NCT00792298|147595119|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|5.2||||0.002|TWO_SIDED|95.0|1.9|8.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||8.6|1.9|0.002
74021066|NCT00792298|147595119|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|4.7||||0.003|TWO_SIDED|95.0|1.6|7.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||7.8|1.6|0.003
74021067|NCT00792298|147595120|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-36.8|||<|0.001|TWO_SIDED|95.0|-49.4|-24.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-24.3|-49.4|<0.001
74021068|NCT00792298|147595120|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-28.9|||<|0.001|TWO_SIDED|95.0|-42.1|-15.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.7|-42.1|<0.001
74021069|NCT00792298|147595120|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-33.9|||<|0.001|TWO_SIDED|95.0|-46.4|-21.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-21.5|-46.4|<0.001
74021070|NCT00792298|147595120|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-33.2|||<|0.001|TWO_SIDED|95.0|-46.3|-20.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-20.2|-46.3|<0.001
74021071|NCT00792298|147595120|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-24.7|||<|0.001|TWO_SIDED|95.0|-37.1|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-12.3|-37.1|<0.001
74021072|NCT00792298|147595120|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-28.1|||<|0.001|TWO_SIDED|95.0|-41.0|-15.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.1|-41.0|<0.001
73898153|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74021073|NCT00792298|147595120|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-21.2|||<|0.001|TWO_SIDED|95.0|-33.5|-8.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.8|-33.5|<0.001
74021074|NCT00792298|147595120|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-21.4||||0.001|TWO_SIDED|95.0|-34.2|-8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.7|-34.2|0.001
74021075|NCT00792298|147595121|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-25.4|||<|0.001|TWO_SIDED|95.0|-37.7|-13.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-13.1|-37.7|<0.001
74021076|NCT00792298|147595121|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-9.5||||0.068|TWO_SIDED|95.0|-19.7|0.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||0.7|-19.7|0.068
74021077|NCT00792298|147595121|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-23.1|||<|0.001|TWO_SIDED|95.0|-35.3|-10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-10.9|-35.3|<0.001
74021078|NCT00792298|147595121|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-3.8||||0.459|TWO_SIDED|95.0|-13.8|6.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||6.3|-13.8|0.459
74021079|NCT00792298|147595121|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-9.4||||0.13|TWO_SIDED|95.0|-21.5|2.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||2.8|-21.5|0.130
74021080|NCT00792298|147595121|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-22.3|||<|0.001|TWO_SIDED|95.0|-32.3|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-12.3|-32.3|<0.001
74021081|NCT00792298|147595121|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-3.4||||0.577|TWO_SIDED|95.0|-15.6|8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||8.7|-15.6|0.577
74081031|NCT05497557|147714105|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.677|||||TWO_SIDED|90.0|0.547|0.839||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.839|0.547|
74081032|NCT05497557|147714106|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.771|||||TWO_SIDED|90.0|0.628|0.948||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.948|0.628|
74081033|NCT05497557|147714107|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.766|||||TWO_SIDED|90.0|0.619|0.948||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.948|0.619|
74081034|NCT02752074|147714111|OTHER||Hazard Ratio (HR)|1.0||||0.51711|TWO_SIDED|95.0|0.83|1.21||One-sided p-value based on log-rank test.|Log Rank|||||1.21|0.83|0.51711
74081035|NCT02752074|147714112|OTHER||Hazard Ratio (HR)|1.13||||0.80666|TWO_SIDED|95.0|0.86|1.49||One-sided p-value based on log-rank test.|Log Rank|||||1.49|0.86|0.80666
74021082|NCT00792298|147595121|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-2.3||||0.644|TWO_SIDED|95.0|-12.2|7.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||7.5|-12.2|0.644
74021083|NCT00792298|147595122|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-22.3||||0.007|TWO_SIDED|95.0|-38.3|-6.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-6.2|-38.3|0.007
74021084|NCT00792298|147595122|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-19.6||||0.024|TWO_SIDED|95.0|-36.6|-2.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-2.6|-36.6|0.024
74021085|NCT00792298|147595122|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-31.0|||<|0.001|TWO_SIDED|95.0|-46.9|-15.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.2|-46.9|<0.001
74021086|NCT00792298|147595122|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-15.7||||0.063|TWO_SIDED|95.0|-32.3|0.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||0.8|-32.3|0.063
74021087|NCT00792298|147595122|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-17.4||||0.03|TWO_SIDED|95.0|-33.1|-1.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-1.7|-33.1|0.030
74021088|NCT00792298|147595122|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-24.6||||0.003|TWO_SIDED|95.0|-41.0|-8.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.3|-41.0|0.003
74021089|NCT00792298|147595122|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-19.1||||0.02|TWO_SIDED|95.0|-35.1|-3.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-3.0|-35.1|0.020
74021090|NCT00792298|147595122|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-20.2||||0.019|TWO_SIDED|95.0|-37.0|-3.4|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-3.4|-37.0|0.019
74021091|NCT02388295|147595131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.24||0.13|ONE_SIDED|||||Not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline within treatment arm||||0.13
74021092|NCT02388295|147595131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.25||0.91|ONE_SIDED|||||not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline||||0.91
74021093|NCT02388295|147595131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.68|ONE_SIDED||||||ANOVA|no adjustments|larger negagtive values (powereed to detect -0.50)|Change from baseline||||0.68
74021094|NCT02388295|147595131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.34||0.32|TWO_SIDED|||||no adjustment|ANOVA||Looking for negative direction to indicate treatment better than placebo|Secondary objective - comparison to placebo||||0.32
74021095|NCT02388295|147595131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.36||0.45|TWO_SIDED|||||no adjustment|ANOVA||lookin for negative difference compared to placebo|Secondary objective||||0.45
74021096|NCT04258579|147595137|OTHER|Estimation only.|Mean value at 6 weeks|19.13|||||TWO_SIDED|95.0|15.59|22.67||||||||22.67|15.59|
74021097|NCT04258579|147595137|OTHER|Estimation only.|Mean value at 9 weeks|16.87|||||TWO_SIDED|95.0|12.5|21.24||||||||21.24|12.50|
74021098|NCT04258579|147595137|OTHER|Estimation only.|Mean value at 12 weeks|15.0|||||TWO_SIDED|95.0|11.24|18.76||||||||18.76|11.24|
74021099|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 6 weeks, Domain 1|22.1|||||TWO_SIDED|95.0|19.7|24.5||||||||24.50|19.70|
74021100|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 6 weeks, Domain 2|19.9|||||TWO_SIDED|95.0|18.0|21.8||||||||21.80|18.00|
74021101|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 6 weeks, Domain 3|8.93|||||TWO_SIDED|95.0|7.68|10.18||||||||10.18|7.68|
74021102|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 6 weeks, Domain 4|26.63|||||TWO_SIDED|95.0|24.32|28.94||||||||28.94|24.32|
74021103|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 9 weeks, Domain 1|22.53|||||TWO_SIDED|95.0|19.87|25.23||||||||25.23|19.87|
74021104|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 9 weeks, Domain 2|21.0|||||TWO_SIDED|95.0|18.87|23.13||||||||23.13|18.87|
74021105|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 9 weeks, Domain 3|8.69|||||TWO_SIDED|95.0|7.39|9.99||||||||9.99|7.39|
74021106|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 9 weeks, Domain 4|27.38|||||TWO_SIDED|95.0|25.07|29.69||||||||29.69|25.07|
74021107|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 12 weeks, Domain 1|22.62|||||TWO_SIDED|95.0|20.18|25.06||||||||25.06|20.18|
74021108|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 12 weeks, Domain 2|21.58|||||TWO_SIDED|95.0|19.84|23.32||||||||23.32|19.84|
74021109|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 12 weeks, Domain 3|9.19|||||TWO_SIDED|95.0|7.92|10.46||||||||10.46|7.92|
74021110|NCT04258579|147595138|OTHER|Estimation only.|Mean value at 12 weeks, Domain 4|27.81|||||TWO_SIDED|95.0|25.53|30.09||||||||30.09|25.53|
74081036|NCT00907907|147714125|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.97||||||90.0|80.25|110.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.04|80.25|
74081037|NCT00907907|147714126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|102.01||||||90.0|98.74|105.39|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.39|98.74|
74081038|NCT00907907|147714127|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.91||||||90.0|95.99|103.98|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.98|95.99|
74021111|NCT04258579|147595139|OTHER|Estimation only.|Mean value at baseline|22.45|||||TWO_SIDED|95.0|19.56|25.34||||||||25.34|19.56|
74021112|NCT04258579|147595139|OTHER|Estimation only.|Mean value at 6 weeks|20.53|||||TWO_SIDED|95.0|17.65|23.41||||||||23.41|17.65|
74021113|NCT04258579|147595140|OTHER|Estimation only.|Mean value at baseline, Domain 1|19.89|||||TWO_SIDED|95.0|17.24|22.54||||||||22.54|17.24|
74021114|NCT04258579|147595140|OTHER|Estimation only.|Mean value at baseline, Domain 2|22.46|||||TWO_SIDED|95.0|19.72|25.2||||||||25.20|19.72|
74021115|NCT04258579|147595140|OTHER|Estimation only.|Mean value at baseline, Domain 3|16.0|||||TWO_SIDED|95.0|13.72|18.28||||||||18.28|13.72|
74021116|NCT04258579|147595140|OTHER|Estimation only.|Mean value at baseline, Domain 4|17.79|||||TWO_SIDED|95.0|15.34|20.24||||||||20.24|15.34|
74021117|NCT04258579|147595140|OTHER|Estimation only.|Mean value at 6 weeks, Domain 1|22.79|||||TWO_SIDED|95.0|19.05|26.53||||||||26.53|19.05|
74021118|NCT04258579|147595140|OTHER|Estimation only.|Mean value at 6 weeks, Domain 2|26.7|||||TWO_SIDED|95.0|22.96|30.44||||||||30.44|22.96|
74021119|NCT04258579|147595140|OTHER|Estimation only.|Mean value at 6 weeks, Domain 3|17.45|||||TWO_SIDED|95.0|14.57|20.33||||||||20.33|14.57|
74021120|NCT04258579|147595140|OTHER|Estimation only.|Mean value at 6 weeks, Domain 4|20.69|||||TWO_SIDED|95.0|18.23|23.15||||||||23.15|18.23|
74021121|NCT02076165|147595155|SUPERIORITY||||||=|0.12|||||||Fisher Exact|||Percentage of participants who completed all 5 treatment sessions, comparing ABC-I to CBT-I.||||=.120
74021122|NCT02076165|147595156|SUPERIORITY||Mean Difference (Final Values)|-0.711|STANDARD_ERROR_OF_MEAN|3.59|=|0.843|TWO_SIDED|95.0|-7.75|6.32|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual bed time. Negative values indicate the number of minutes earlier than the recommended bed time that the participant went to bed, indicating greater non-adherence.|||6.32|-7.75|=.843
74021123|NCT02076165|147595157|SUPERIORITY||Mean Difference (Final Values)|-2.78|STANDARD_ERROR_OF_MEAN|5.17|=|0.59|TWO_SIDED|95.0|-12.91|7.35|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual rise time. Positive values indicate the number of minutes later than the recommended rise time that the participant got out of bed, indicating greater non-adherence.|||7.35|-12.91|=0.590
74021124|NCT02076165|147595158|SUPERIORITY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.048|=|0.979|TWO_SIDED|95.0|-0.093|0.096|||Mixed Models Analysis||The proportion of nights participants who did not follow the recommendation to get out of bed if awake more than 20 minutes. Higher numbers indicate greater non-adherence.|||0.096|-0.093|=0.979
74021125|NCT02076165|147595159|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.409|STANDARD_ERROR_OF_MEAN|2.02|=|0.004|TWO_SIDED|90.0|-2.92|3.74|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||3.74|-2.92|=0.004
74021126|NCT02076165|147595160|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.757|STANDARD_ERROR_OF_MEAN|2.12||0.003|TWO_SIDED|90.0|-2.72|4.23|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||4.23|-2.72|.003
74021127|NCT02076165|147595161|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|90.0|-1.21|2.57|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||2.57|-1.21|<0.001
74021128|NCT02076165|147595162|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|90.0|-1.14|3.36|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||3.36|-1.14|<.001
74021129|NCT02076165|147595163|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|0.501|STANDARD_ERROR_OF_MEAN|0.9|=|0.048|TWO_SIDED|90.0|-0.98|1.98|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||1.98|-0.98|=0.048
74021130|NCT02076165|147595164|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|1.06|=|0.008|TWO_SIDED|90.0|-2.32|1.17|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||1.17|-2.32|=0.008
74021131|NCT01838044|147595190|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.287||0.6012|TWO_SIDED|95.0|-0.72|0.42|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between two study arms.||0.42|-0.72|0.6012
74021132|NCT01838044|147595191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.42|||<|0.0001|TWO_SIDED|95.0|1.02|1.83|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B at Week 10.||1.83|1.02|<0.0001
74021133|NCT01838044|147595192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.361||0.5128|TWO_SIDED|95.0|-0.48|0.95|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B compared between two study arms at Week 10.||0.95|-0.48|0.5128
74021134|NCT01838044|147595194|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7251|TWO_SIDED|95.0|-0.22|0.32|||Mixed Models Analysis|||Statistical analysis at Week 5 based on comparison between treatment groups.||0.32|-0.22|0.7251
74021135|NCT01838044|147595194|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1255|TWO_SIDED|95.0|-0.06|0.46|||Mixed Models Analysis|||Statistical analysis at Week 10 based on comparison between treatment groups.||0.46|-0.06|0.1255
74021136|NCT01838044|147595196|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.317||0.2856|TWO_SIDED|95.0|-0.97|0.29|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between treatment groups.||0.29|-0.97|0.2856
74021137|NCT01838044|147595196|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.363||0.3987|TWO_SIDED|95.0|-1.02|0.41|||Mixed Models Analysis|||Statistical analysis at Week 10 compared between treatment groups.||0.41|-1.02|0.3987
73836827|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.19|5.46||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.46|0.19|
74021138|NCT00125034|147595205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.516||||0.064|TWO_SIDED|95.0|0.975|2.335|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||Assuming a difference in rate of best confirmed response of at least 20% between the 2 treatments, ie an approximately 70% response rate under cetuximab plus FOLFOX-4 \& 50% under FOLFOX-4 alone for the stratum with ECOG PS0-1 \& 66% and 45% respectively for the ECOG PS2 stratum, the common OddsR over the strata was expected to be 2.33. A sample size of approximately 146/group was calculated as necessary to detect a significant overall response of at least 2.33 at level α=0.05 with a power of 90%||2.335|0.975|0.064
74021139|NCT00125034|147595206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.551||||0.0027|TWO_SIDED|95.0|1.38|4.717|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||||4.717|1.380|0.0027
74021140|NCT00125034|147595207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.459||||0.029|TWO_SIDED|95.0|0.228|0.924|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||||0.924|0.228|0.0290
74021141|NCT00125034|147595208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.931||||0.617|TWO_SIDED|95.0|0.705|1.23|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.230|0.705|0.6170
74021142|NCT00125034|147595209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.567||||0.0064|TWO_SIDED|95.0|0.375|0.856|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||0.856|0.375|0.0064
74021143|NCT00125034|147595210|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72||||0.0153|TWO_SIDED|95.0|1.104|2.679|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||2.679|1.104|0.0153
74021144|NCT00125034|147595211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015||||0.905|TWO_SIDED|95.0|0.791|1.303|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.303|0.791|0.9050
74021145|NCT00125034|147595212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.855||||0.3854|TWO_SIDED|95.0|0.599|1.219|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.219|0.599|0.3854
74021146|NCT00125034|147595213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.2004|TWO_SIDED|95.0|0.873|1.906|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.906|0.873|0.2004
74021147|NCT03529409|147595218|SUPERIORITY||Mean Difference (Net)|-0.287||||0.01|TWO_SIDED|95.0|-0.507|-0.066|||Mixed Models Analysis|||||-.066|-.507|.01
74021148|NCT03529409|147595219|SUPERIORITY||Mean Difference (Net)|1.95||||0.28|TWO_SIDED|95.0|-1.61|5.5||The overall omnibus test of the time by treatment interaction was p=.55. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||5.50|-1.61|.28
74021149|NCT03529409|147595220|SUPERIORITY||Mean Difference (Net)|157.0||||0.16|TWO_SIDED|95.0|-67.0|382.0||The overall omnibus test of the time by treatment interaction was p=.38. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||382|-67|.16
74021150|NCT03529409|147595221|SUPERIORITY||Mean Difference (Net)|0.25||||0.77|TWO_SIDED|95.0|-1.51|2.0||The overall omnibus test of the time by treatment interaction was p=.90. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||2.00|-1.51|.77
74021151|NCT03529409|147595222|SUPERIORITY||Mean Difference (Net)|0.71||||0.63|TWO_SIDED|95.0|-2.24|3.67||The overall omnibus test of the time by treatment interaction was p=.55. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||3.67|-2.24|.63
74021152|NCT03529409|147595223|SUPERIORITY||Mean Difference (Net)|84.0||||0.44|TWO_SIDED|95.0|-136.0|304.0||The overall omnibus test of the time by treatment interaction was p=.38. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||304|-136|.44
74021153|NCT03529409|147595224|SUPERIORITY||Mean Difference (Net)|-0.16||||0.87|TWO_SIDED|95.0|-1.85|1.58||The overall omnibus test of the time by treatment interaction was p=.90. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||1.58|-1.85|.87
74021154|NCT03529409|147595229|SUPERIORITY||Mean Difference (Net)|-0.47||||0.65|TWO_SIDED|95.0|-2.49|1.55||The overall omnibus test of the time by treatment interaction was p=.89. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||1.55|-2.49|.65
74021155|NCT03529409|147595230|SUPERIORITY||Mean Difference (Net)|3.3||||0.63|TWO_SIDED|95.0|-10.5|17.1||The overall omnibus test of the time by treatment interaction was p=.66. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||17.1|-10.5|.63
74021156|NCT03529409|147595231|SUPERIORITY||Mean Difference (Net)|-0.03||||0.85|TWO_SIDED|95.0|-0.34|0.28||The overall omnibus test of the time by treatment interaction was p=.94. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||.28|-.34|.85
74021157|NCT00484315|147595255|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was \< 4.1%, given the data, was at least 95%. The sample size of 1264 subjects (resulting in 1200 after accounting for 5% attrition) was determined through simulations based on Bayesian modeling.|Median Difference (Final Values)|-0.57|STANDARD_DEVIATION|0.0155||0.9996|ONE_SIDED|95.0||1.85||The p-value is the posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was \< 4.1%, given the data observed.|Bayesian modeling||Values are based on the posterior distribution of the difference in TLF rates between TAXUS Element and TAXUS Express. The upper limit is the 1-Sided 95% posterior credible interval, based off the 95th percentile of the posterior distribution.|Bayesian modeling was used to determine if the 12-month TLF rate for the TAXUS Element stent was non-inferior to the 12-month TLF rate in the TAXUS Express2 control. The null hypothesis was that the TAXUS Element TLF rate is at least 4.1% greater than the TAXUS Express TLF rate. The alternative hypothesis was that the TAXUS Element TLF rate is less than 4.1% greater than the TAXUS Express TLF rate.||1.85||0.9996
74021158|NCT00484315|147595256|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was \< 0.20, given the data, was at least 95%. The sample size of 330 subjects (resulting in 280 after accounting for 15% attrition) was determined through simulations based on Bayesian modeling.|Mean Difference (Final Values)|-0.0294|STANDARD_DEVIATION|0.08253||0.997|ONE_SIDED|95.0||0.1078||P-value is posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was \< 0.20, given the data observed. Non-inferiority was concluded, as this probability is greater than 95%.|Bayesian modeling||Based on posterior distribution of the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express. Upper limit is 1-Sided 95% posterior credible interval, based off the 95th percentile of posterior distribution.|Natural log (ln) transformation was used to improve normality of the secondary endpoint distribution. Bayesian modeling was used to determine if the mean ln(9-month percent diameter stenosis) for the TAXUS Element stent was non-inferior to the mean ln(9-month %DS) for TAXUS Express. Null hypothesis was that the TAXUS Element mean was at least 0.20 greater than the TAXUS Express mean. Alternative hypothesis was that the TAXUS Element mean is less than 0.20 greater than the TAXUS Express TLF mean.||0.1078||0.9970
74021159|NCT00749190|147595262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.0226|TWO_SIDED|95.0|-0.44|-0.03||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 1 mg minus placebo|||-0.03|-0.44|0.0226
74021160|NCT00749190|147595262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.59|-0.18||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 5 mg minus placebo|||-0.18|-0.59|0.0002
74021161|NCT00749190|147595262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.51||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 10 mg minus placebo|||-0.51|-0.91|<0.0001
74021162|NCT00749190|147595262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.5||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 25 mg minus placebo|||-0.50|-0.91|<0.0001
74081039|NCT00545792|147714129|SUPERIORITY_OR_OTHER||Single point estiamte of 1-yr PFS|0.8|||||TWO_SIDED|95.0|0.56|0.94|||||The reported 1-year PFS rate 80% (Exact 95% CI: 56% - 94%) was the proportion of the patients remained progression free after 12 months.|Single-arm feasibility study; Kaplan Meier analysis was applied to estimate one-year PFS distribution as well as to calculate proportion of patients remain progression free by month 12.||0.94|0.56|
74081040|NCT06078501|147714137|OTHER|||||||0.695||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.695
74021163|NCT00749190|147595262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.84|-0.43||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 50 mg minus placebo|||-0.43|-0.84|<0.0001
74021164|NCT01565980|147595301|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P-values for the comparison of least square (LS) means represent the effect of the trial arm. The effect sizes are calculated as Cohen's d: difference between LS means divided by the standard deviation.|Mixed Models Analysis|||The outcome measure was analyzed using linear mixed effects models (LME). The main effect of the trial arm was evaluated by averaging time 2 and time 3 values of the outcomes within the LME model. The resulting least square (LS) means and their standard errors are reported.||||<.05
74021165|NCT01565980|147595302|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
74021166|NCT01565980|147595303|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<.05
74021167|NCT01565980|147595304|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
74021168|NCT01565980|147595305|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
74021169|NCT01565980|147595306|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
74021170|NCT01565980|147595307|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values above 0.05 are considered statistically insignificant in this study.|Descriptive statistics for outcomes|||||||<0.05
74021171|NCT04533711|147595322|SUPERIORITY||Mean Difference (Final Values)|8.35||||0.3086|TWO_SIDED|95.0|-7.68|24.38|||Mixed Models Analysis|||||24.38|-7.68|0.3086
74021172|NCT04533711|147595323|SUPERIORITY||Mean Difference (Final Values)|10.93||||0.182|TWO_SIDED|95.0|-5.06|26.92|||Mixed Models Analysis|||||26.92|-5.06|0.1820
74021173|NCT04533711|147595324|SUPERIORITY||Mean Difference (Final Values)|308.4||||0.094|TWO_SIDED|95.0|-50.2|667.1|||Mixed Models Analysis|||||667.1|-50.2|0.094
74021174|NCT04533711|147595325|SUPERIORITY||Mean Difference (Final Values)|352.0||||0.0691|TWO_SIDED|95.0|-25.2|729.2|||Mixed Models Analysis|||||729.2|-25.2|0.0691
74021175|NCT04533711|147595326|SUPERIORITY||Mean Difference (Final Values)|-5.85||||0.4953|TWO_SIDED|95.0|-22.6|10.94|||Mixed Models Analysis|||||10.94|-22.6|0.4953
74021176|NCT04533711|147595327|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.8041|TWO_SIDED|95.0|-20.0|15.49|||Mixed Models Analysis|||||15.49|-20.0|0.8041
74021177|NCT04533711|147595328|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.9645|TWO_SIDED|95.0|-2.86|2.99|||Mixed Models Analysis|||||2.99|-2.86|0.9645
74021178|NCT04533711|147595329|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0989|TWO_SIDED|95.0|-5.85|0.49|||Mixed Models Analysis|||||0.49|-5.85|0.0989
74081041|NCT06078501|147714138|OTHER|||||||0.91|||||||Mann-Whitney U test|The a priori threshold for statistical significance was \<0.05.||||||0.91
74021179|NCT04533711|147595330|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.7667|TWO_SIDED|95.0|-0.77|1.05|||Mixed Models Analysis|||||1.05|-0.77|0.7667
74021180|NCT04533711|147595331|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.0894|TWO_SIDED|95.0|-1.87|0.13|||Mixed Models Analysis|||||0.13|-1.87|0.0894
74021181|NCT02689492|147595334|OTHER||Intercept|68.5027|STANDARD_DEVIATION|8.0355|||||||||||Standard deviation is actually standard error.|||||
74021182|NCT02689492|147595335|OTHER||Intercept|95.4051|STANDARD_DEVIATION|6.9951|||||||||||Standard deviation is actually standard error.|||||
74021183|NCT02689492|147595336|OTHER||Intercept|74.8895|STANDARD_DEVIATION|8.0048|||||||||||Standard deviation is actually standard error.|||||
74021184|NCT04025632|147595343|SUPERIORITY||Wilcoxon-Mann-Whitney odds|0.55||||0.464|TWO_SIDED|95.0|0.19|1.57||Conducted using a 2-sided Van Elteren test, which represents an extension of the Wilcoxon rank sum test for comparing 2 treatments in a stratified experiment using within-stratum ranks assigning greater weight to rank sums from smaller strata.|2-sided Van Elteren test||The magnitude of association between treatment groups was expressed as in Wilcoxon-Mann-Whitney odds followed by the 95% confidence intervals.|||1.57|0.19|0.464
74081042|NCT06078501|147714139|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1.0
74021185|NCT04025632|147595345|SUPERIORITY||Odds Ratio (OR)|1.088||||0.919|TWO_SIDED|95.0|0.214|5.535||P-value for the comparison of treatment groups was calculated using logistic regression with investigational medicinal product and strata as fixed factors.|Regression, Logistic|||||5.535|0.214|0.919
74021186|NCT04025632|147595346|SUPERIORITY||Least squares (LS) mean difference|-0.688||||0.496|TWO_SIDED|95.0|-2.781|1.404||Based on a linear model with treatment and strata (anti-3-hydroxy-3-methyl-glutaryl-coenzyme A reductase \[HMGCR\]+/anti-signal recognition particle \[SRP\]+) as fixed factors with Baseline 3TUG as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||1.404|-2.781|0.496
74021187|NCT04025632|147595347|SUPERIORITY||LS mean difference|3.89||||0.431|TWO_SIDED|95.0|-6.18|13.95||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline proximal MMT as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||13.95|-6.18|0.431
74021188|NCT04025632|147595348|SUPERIORITY||LS mean difference|-0.204||||0.8|TWO_SIDED|95.0|-1.855|1.448||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline Physician Global Activity VAS as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||1.448|-1.855|0.800
74021189|NCT04025632|147595349|SUPERIORITY||LS mean difference|-1.281||||0.221|TWO_SIDED|95.0|-3.39|0.829||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline Patient Global Activity VAS as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.829|-3.390|0.221
74021190|NCT04025632|147595350|SUPERIORITY||LS mean difference|-0.147||||0.508|TWO_SIDED|95.0|-0.601|0.307||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline HAQ as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.307|-0.601|0.508
74021191|NCT04025632|147595351|SUPERIORITY||LS mean difference|-0.143||||0.765|TWO_SIDED|95.0|-1.123|0.837|||Linear Mixed Effect Model|Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline MDAAT as a covariate.|The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.837|-1.123|0.765
74021192|NCT04025632|147595352|SUPERIORITY||LS mean difference|5.53||||0.265|TWO_SIDED|95.0|-4.49|15.55||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline FACIT-Fatigue Scale as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||15.55|-4.49|0.265
74021193|NCT00391599|147595357|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Chi-squared|||||||0.15
74021194|NCT00391599|147595359|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
74021195|NCT04355013|147595367|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Bland-Altman for repeated measures|-0.16|STANDARD_DEVIATION|0.47|||TWO_SIDED|95.0|-1.1|0.77||||||Arterial outlet-nasopharyngeal temperatures||0.77|-1.10|
74021196|NCT04355013|147595367|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.4|||TWO_SIDED|95.0|-0.63|0.95|||Bland-Altman|||Arterial-venous inflow temperatures||0.95|-0.63|
74021197|NCT04355013|147595367|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|-0.62|STANDARD_DEVIATION|0.69|||TWO_SIDED|95.0|-1.98|0.74|||Bland-Altman|||Arterial outlet-bladder||0.74|-1.98|
74021198|NCT04355013|147595367|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|0.74|||TWO_SIDED|95.0|-1.38|1.54|||Bland-Altman|||Arterial outlet- Tcore||1.54|-1.38|
74021199|NCT04355013|147595367|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|0.53|||TWO_SIDED|95.0|-0.73|1.38||||||Nasopharyngeal-venous inflow temperatures||1.38|-0.73|
74021200|NCT04355013|147595367|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|-0.46|STANDARD_DEVIATION|0.52|||TWO_SIDED|95.0|-1.5|0.59||||||Nasopharyngeal-bladder temperatures||0.59|-1.50|
74021201|NCT04355013|147595367|OTHER|Bland-Altman for repeated measures|Bland-Altman for repeated measures|0.24|STANDARD_DEVIATION|0.58|||TWO_SIDED|95.0|-0.9|1.39||||||Nasopharyngeal-Tcore temperatures||1.39|-0.90|
74021202|NCT03155997|147595374|SUPERIORITY||Hazard Ratio (HR)|0.747||||0.00957|TWO_SIDED|95.0|0.598|0.932|||Log Rank|Stratified by Interactive Web Response Systems (IWRS) Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|||0.932|0.598|0.00957
74021203|NCT03155997|147595376|SUPERIORITY||Hazard Ratio (HR)|0.717|||||TWO_SIDED|95.0|0.559|0.92|||||Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|||0.920|0.559|
73898154|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.065||0.537|TWO_SIDED|95.0|-0.088|0.168||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.168|-0.088|0.537
74021204|NCT00862251|147595397|SUPERIORITY_OR_OTHER_LEGACY||Percent change in least-square means|-14.76|||<|0.001|TWO_SIDED|95.0|-19.61|-9.91|||Longitudinal data analysis (LDA)|||||-9.91|-19.61|<0.001
74021205|NCT00862251|147595398|SUPERIORITY_OR_OTHER_LEGACY||Percent change in Least Square Means|-13.62|||<|0.001|TWO_SIDED|95.0|-20.44|-6.79|||Longitudinal data analysis (LDA)|||||-6.79|-20.44|<0.001
74021206|NCT00862251|147595399|SUPERIORITY_OR_OTHER_LEGACY||Percent change in least squares mean|-15.73|||<|0.001|TWO_SIDED|95.0|-22.65|-8.81|||Longitudinal Data Analysis (LDA)|||||-8.81|-22.65|<0.001
74021207|NCT00862251|147595400|SUPERIORITY_OR_OTHER_LEGACY||Percent Change in Least Squares Means|-3.81||||0.06|TWO_SIDED|95.0|-7.78|0.17|||Longitudinal Data Analysis|||||0.17|-7.78|0.060
74021208|NCT00862251|147595401|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.5|6.2|||Regression, Logistic|||||6.2|2.5|<0.001
74021209|NCT00862251|147595401|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.3|2.6|||Regression, Logistic|||||2.6|1.3|<0.001
74021210|NCT00862251|147595402|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5|||<|0.001|TWO_SIDED|95.0|2.3|8.5|||Regression, Logistic|||||8.5|2.3|<0.001
74081043|NCT06078501|147714140|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1.0
74021211|NCT00862251|147595403|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|1.9|6.6|||Regression, Logistic|||||6.6|1.9|<0.001
74021212|NCT00862251|147595404|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.33|||<|0.001|TWO_SIDED|95.0|-11.38|-5.28|||Longitudinal data analysis (LDA)|||||-5.28|-11.38|<0.001
74081044|NCT06078501|147714141|OTHER|||||||0.887||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.887
74021213|NCT00862251|147595404|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.63||||0.039|TWO_SIDED|95.0|-5.13|-0.13|||Longitudinal data analysis (LDA)|||||-0.13|-5.13|0.039
74021214|NCT00862251|147595405|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.88||||0.316|TWO_SIDED|95.0|-8.53|2.77|||Longitudinal data analysis (LDA)|||||2.77|-8.53|0.316
74021215|NCT00862251|147595405|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.16||||0.356|TWO_SIDED|95.0|-6.75|2.43|||Longitudinal data analysis (LDA)|||||2.43|-6.75|0.356
74021216|NCT00862251|147595406|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.47||||0.756|TWO_SIDED|95.0|-2.5|3.45|||Longitudinal data analysis (LDA)|||||3.45|-2.50|0.756
74021217|NCT00862251|147595406|SUPERIORITY_OR_OTHER_LEGACY||Least Sqares Mean Difference|-0.52||||0.675|TWO_SIDED|95.0|-2.96|1.92|||Longitudinal data analysis (LDA)|||||1.92|-2.96|0.675
74021218|NCT00862251|147595407|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.62|||<|0.001|TWO_SIDED|95.0|-15.93|-7.31|||Longitudinal data analysis (LDA)|||||-7.31|-15.93|<0.001
74021219|NCT00862251|147595407|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.18||||0.078|TWO_SIDED|95.0|-6.71|0.35|||Longitudinal data analysis (LDA)|||||0.35|-6.71|0.078
74081045|NCT06078501|147714142|OTHER|||||||0.887||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.887
74021220|NCT00862251|147595408|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-14.16|||<|0.001|TWO_SIDED|95.0|-20.23|-8.1|||Longitudinal data analysis (LDA)|||||-8.10|-20.23|<0.001
74021221|NCT00862251|147595408|SUPERIORITY_OR_OTHER_LEGACY||Least Sqares Mean Difference|-2.56||||0.313|TWO_SIDED|95.0|-7.53|2.41|||Longitudinal data analysis (LDA)|||||2.41|-7.53|0.313
74021222|NCT00862251|147595409|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.17|||<|0.001|TWO_SIDED|95.0|-12.1|-4.23|||Longitudinal data analysis (LDA)|||||-4.23|-12.10|<0.001
74021223|NCT00862251|147595409|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.83||||0.266|TWO_SIDED|95.0|-5.05|1.4|||Longitudinal data analysis (LDA)|||||1.40|-5.05|0.266
74021224|NCT00862251|147595410|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.45|||<|0.001|TWO_SIDED|95.0|-17.16|-5.75|||Longitudinal data analysis (LDA)|||||-5.75|-17.16|<0.001
74021225|NCT00862251|147595410|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.13||||0.371|TWO_SIDED|95.0|-6.81|2.54|||Longitudinal data analysis (LDA)|||||2.54|-6.81|0.371
74021226|NCT00862251|147595411|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.01|||<|0.001|TWO_SIDED|95.0|-11.46|-4.56|||Longitudinal data analysis (LDA)|||||-4.56|-11.46|<0.001
74021227|NCT00862251|147595411|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.95||||0.041|TWO_SIDED|95.0|-5.78|-0.12|||Longitudinal data analysis (LDA)|||||-0.12|-5.78|0.041
74021228|NCT00862251|147595412|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.57||||0.218|TWO_SIDED|95.0|-0.93|4.06|||Longitudinal data analysis (LDA)|||||4.06|-0.93|0.218
74021229|NCT00862251|147595412|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.22||||0.832|TWO_SIDED|95.0|-2.27|1.83|||Longitudinal data analysis (LDA)|||||1.83|-2.27|0.832
74021230|NCT00862251|147595413|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.91|||<|0.001|TWO_SIDED|95.0|-13.36|-4.47|||Longitudinal data analysis (LDA)|||||-4.47|-13.36|<0.001
74021231|NCT00862251|147595413|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.52||||0.175|TWO_SIDED|95.0|-6.17|1.13|||Longitudinal data analysis (LDA)|||||1.13|-6.17|0.175
74021232|NCT00862251|147595414|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.78||||0.749|TWO_SIDED|95.0|-19.88|14.32|||Longitudinal data analysis (LDA)|||||14.32|-19.88|0.749
74021233|NCT00862251|147595414|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|4.69||||0.494|TWO_SIDED|95.0|-8.73|18.1|||Longitudinal data analysis (LDA)|||||18.10|-8.73|0.494
74021234|NCT00891995|147595418|SUPERIORITY_OR_OTHER|||||||0.49||||||One-sided p-value.|ANCOVA|Adjusted for baseline C-peptide AUC, age, gender and diabetic ketoacidosis.||||||0.49
74021235|NCT00891995|147595421|SUPERIORITY_OR_OTHER|||||||0.4||||||One-sided p-value|ANCOVA|Adjusted for baseline A1c, age, gender and Diabetic ketoacidosis||||||0.40
74021236|NCT02054702|147595427|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for brexpiprazole.||||<0.0001
74021237|NCT02054702|147595427|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for aripiprazole.||||<0.0001
74021238|NCT02054702|147595428|SUPERIORITY_OR_OTHER|||||||0.4244|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for brexpiprazole.||||0.4244
74021239|NCT02054702|147595428|SUPERIORITY_OR_OTHER|||||||0.7623|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for aripiprazole.||||0.7623
74021240|NCT02054702|147595429|SUPERIORITY_OR_OTHER|||||||0.8759|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.||||0.8759
74021241|NCT02054702|147595429|SUPERIORITY_OR_OTHER|||||||0.2176|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.||||0.2176
74021242|NCT02054702|147595430|SUPERIORITY_OR_OTHER|||||||0.842|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for brexpiprazole.||||0.8420
74021243|NCT02054702|147595430|SUPERIORITY_OR_OTHER|||||||0.3781|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for aripiprazole.||||0.3781
74021244|NCT02054702|147595431|SUPERIORITY_OR_OTHER|||||||0.1807|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for brexpiprazole.||||0.1807
74021245|NCT02054702|147595431|SUPERIORITY_OR_OTHER|||||||0.2802|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for aripiprazole.||||0.2802
74021246|NCT02054702|147595432|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for brexpiprazole.||||0.8622
74021247|NCT02054702|147595432|SUPERIORITY_OR_OTHER|||||||0.4848|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for aripiprazole.||||0.4848
74081046|NCT06078501|147714144|OTHER|||||||1|||||||Fisher Exact|||||||1.0
74081047|NCT06078501|147714145|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||1.0
74081048|NCT06078501|147714146|OTHER|||||||1|||||||Fisher Exact|||||||1.0
74021248|NCT02054702|147595433|SUPERIORITY_OR_OTHER|||||||0.8588|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for brexpiprazole.||||0.8588
74021249|NCT02054702|147595433|SUPERIORITY_OR_OTHER|||||||0.9928|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for aripiprazole.||||0.9928
74021250|NCT02054702|147595434|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 for brexpiprazole.||||<0.0001
74021251|NCT02054702|147595434|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 were observed for aripiprazole.||||<0.0001
74021252|NCT02054702|147595437|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|The analysis of covariance (ANCOVA) model with treatment group and total score at baseline as covariate was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for brexpiprazole.||||<0.0001
74021253|NCT02054702|147595437|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for aripiprazole.||||<0.0001
74021254|NCT02054702|147595438|SUPERIORITY_OR_OTHER|||||||0.0392|TWO_SIDED||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for brexpiprazole.||||0.0392
74021255|NCT02054702|147595438|SUPERIORITY_OR_OTHER|||||||0.9716|TWO_SIDED||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for aripiprazole.||||0.9716
74021256|NCT00109473|147595444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0||||0.02|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.02
74021257|NCT03417440|147595457|SUPERIORITY||Estimated mean change|-898.0||||0.37|TWO_SIDED|95.0|-2884.82|1088.82||A single model was run including variables indicating Proof Positive (yes/no), Coach Me (yes/no), and On Your Feet (yes/no) and their interaction terms.|Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||1088.82|-2884.82|.37
74021258|NCT03417440|147595457|SUPERIORITY||Estimated mean change|-2602.1||||0.02|TWO_SIDED|95.0|-4687.44|-516.69||A single model was run including variables indicating Proof Positive (yes/no), Coach Me (yes/no), and On Your Feet (yes/no) and their interaction terms.|Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||-516.69|-4687.44|.02
74021259|NCT03417440|147595457|SUPERIORITY||Estimated mean change|-1244.9||||0.23|TWO_SIDED|95.0|-3287.6|797.85|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||797.85|-3287.60|.23
74021260|NCT03417440|147595457|SUPERIORITY||Estimated mean change|1468.5||||0.31|TWO_SIDED|95.0|-1368.93|4306.02|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||4306.02|-1368.93|0.31
74021261|NCT03417440|147595457|SUPERIORITY||Estimated mean change|388.1||||0.78|TWO_SIDED|95.0|-2397.51|3173.62|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||3173.62|-2397.51|0.78
74021262|NCT03417440|147595457|SUPERIORITY||Estimated mean change|1991.2||||0.17|TWO_SIDED|95.0|-865.52|4847.86|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||4847.86|-865.52|0.17
74021263|NCT03417440|147595457|SUPERIORITY||Estimated mean change|-590.7||||0.77|TWO_SIDED|95.0|-4591.17|3409.75|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||3409.75|-4591.17|0.77
74021264|NCT03417440|147595458|SUPERIORITY||Mean Difference (Net)|-23.0|STANDARD_DEVIATION|118.7||0.17|ONE_SIDED|90.0||8.3||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||8.3||0.17
74021265|NCT03417440|147595458|SUPERIORITY||Mean Difference (Net)|37.7|STANDARD_DEVIATION|117.8||0.94|ONE_SIDED|90.0||68.8||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||68.8||0.94
74021266|NCT03417440|147595458|SUPERIORITY||Mean Difference (Net)|52.0|STANDARD_DEVIATION|116.4||0.99|ONE_SIDED|90.0||82.7||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||82.7||0.99
74081049|NCT02554877|147714158|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.91|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.34|-0.48||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-0.48|-1.34|<0.0001
74021267|NCT03417440|147595459|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_DEVIATION|51.0||0.47|ONE_SIDED|90.0|-12.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-12.5|0.47
74021268|NCT03417440|147595459|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_DEVIATION|51.0||0.315|ONE_SIDED|90.0|-8.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-8.3|0.315
74021269|NCT03417440|147595459|SUPERIORITY||Mean Difference (Net)|3.9|STANDARD_DEVIATION|51.0||0.355|ONE_SIDED|90.0|-9.4|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-9.4|0.355
74021270|NCT03417440|147595460|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.0||0.86|ONE_SIDED|90.0|-1.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.3|0.86
74021271|NCT03417440|147595460|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.0||0.38|ONE_SIDED|90.0|-0.6|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.6|0.38
74021272|NCT03417440|147595460|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|1.0||0.66|ONE_SIDED|90.0|-1.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.1|0.66
74021273|NCT03417440|147595461|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|19.2||0.69|ONE_SIDED|90.0|-6.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-6.9|0.69
74021274|NCT03417440|147595461|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|19.2||0.6|ONE_SIDED|90.0|-6.0|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-6.0|0.60
74021275|NCT03417440|147595461|SUPERIORITY||Mean Difference (Net)|4.8|STANDARD_DEVIATION|19.0||0.11|ONE_SIDED|90.0|-0.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.2|0.11
73898155|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.54|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74021276|NCT03417440|147595462|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.0||0.94|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.94
74021277|NCT03417440|147595462|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.1||0.73|ONE_SIDED|90.0|-0.4|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.4|0.73
74021278|NCT03417440|147595462|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.1||0.22|ONE_SIDED|90.0|-0.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.1|0.22
74021279|NCT03417440|147595463|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.3||0.46|ONE_SIDED|90.0|-0.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.3|0.46
74021280|NCT03417440|147595463|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.2||0.96|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.96
74021281|NCT03417440|147595463|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.3||0.495|ONE_SIDED|90.0|-0.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.3|0.495
74021282|NCT03417440|147595464|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|4.5||0.445|ONE_SIDED|90.0|-1.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.1|0.445
74021283|NCT03417440|147595464|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|4.4||0.92|ONE_SIDED|90.0|-2.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-2.5|0.92
74081050|NCT02554877|147714158|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.16|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.59|-0.73||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-0.73|-1.59|<0.0001
74081051|NCT02554877|147714158|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.17|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.6|-0.74||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||-0.74|-1.60|<0.0001
74081052|NCT02554877|147714159|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|Least squares mean (LS mean) difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 2.||-0.26|-0.52|<0.0001
74081053|NCT02554877|147714159|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.||-0.26|-0.52|<0.0001
74081054|NCT02554877|147714159|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.44|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.57|-0.3||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.||-0.30|-0.57|<0.0001
74081055|NCT02554877|147714159|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.59|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.76|-0.42||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.42|-0.76|<0.0001
74081056|NCT02554877|147714159|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.8|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.46|-0.80|<0.0001
74081057|NCT02554877|147714159|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.62|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.79|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.46|-0.79|<0.0001
74081058|NCT02554877|147714159|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.71|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.93|-0.49||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 8.||-0.49|-0.93|<0.0001
74081059|NCT02554877|147714159|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.96|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.17|-0.74||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects..|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.||-0.74|-1.17|<0.0001
74081060|NCT02554877|147714159|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.98|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.76||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.||-0.76|-1.20|<0.0001
74081061|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-37.83|STANDARD_ERROR_OF_MEAN|5.13|<|0.0001|TWO_SIDED|95.0|-47.96|-27.7||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-27.70|-47.96|<0.0001
74081062|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-44.85|STANDARD_ERROR_OF_MEAN|5.13|<|0.0001|TWO_SIDED|95.0|-54.98|-34.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-34.72|-54.98|<0.0001
74081063|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-48.59|STANDARD_ERROR_OF_MEAN|5.18|<|0.0001|TWO_SIDED|95.0|-58.81|-38.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-38.37|-58.81|<0.0001
74081064|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-30.63|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-42.52|-18.74||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-18.74|-42.52|<0.0001
74081065|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-39.24|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-51.13|-27.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-27.35|-51.13|<0.0001
74081066|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-38.3|STANDARD_ERROR_OF_MEAN|6.04|<|0.0001|TWO_SIDED|95.0|-50.22|-26.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-26.38|-50.22|<0.0001
74081067|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-19.47|STANDARD_ERROR_OF_MEAN|6.29||0.0023|TWO_SIDED|95.0|-31.88|-7.05||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-7.05|-31.88|0.0023
74081068|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-36.98|STANDARD_ERROR_OF_MEAN|6.23|<|0.0001|TWO_SIDED|95.0|-49.27|-24.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-24.69|-49.27|<0.0001
74081069|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-35.14|STANDARD_ERROR_OF_MEAN|6.29|<|0.0001|TWO_SIDED|95.0|-47.55|-22.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-22.72|-47.55|<0.0001
74081070|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-19.77|STANDARD_ERROR_OF_MEAN|6.1||0.0014|TWO_SIDED|95.0|-31.81|-7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||-7.73|-31.81|0.0014
74081071|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-35.26|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-47.17|-23.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-23.35|-47.17|<0.0001
74081072|NCT02554877|147714160|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-36.44|STANDARD_ERROR_OF_MEAN|6.07|<|0.0001|TWO_SIDED|95.0|-48.43|-24.46||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-24.46|-48.43|<0.0001
74081073|NCT02554877|147714161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.057||||0.0059|TWO_SIDED|95.0|1.68|21.82||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||21.82|1.68|0.0059
74081074|NCT02554877|147714161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.927||||0.0008|TWO_SIDED|95.0|2.49|31.96||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||31.96|2.49|0.0008
74081075|NCT02554877|147714161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.116|||<|0.0001|TWO_SIDED|95.0|4.34|52.67||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||52.67|4.34|<0.0001
74081076|NCT02554877|147714161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34||||0.1532|TWO_SIDED|95.0|0.64|17.47||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||17.47|0.64|0.1532
74081077|NCT02554877|147714161|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.198||||0.0826|TWO_SIDED|95.0|0.83|21.22||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||21.22|0.83|0.0826
74081078|NCT02554877|147714161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.588||||0.0272|TWO_SIDED|95.0|1.21|25.73||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||25.73|1.21|0.0272
74081079|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.03|STANDARD_ERROR_OF_MEAN|3.4||0.7618|TWO_SIDED|90.0|-6.66|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||4.59|-6.66|0.7618
74081080|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.65|STANDARD_ERROR_OF_MEAN|3.39||0.8489|TWO_SIDED|90.0|-6.25|4.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||4.96|-6.25|0.8489
74081081|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.47|STANDARD_ERROR_OF_MEAN|3.42||0.4699|TWO_SIDED|90.0|-3.17|8.12||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.12|-3.17|0.4699
74081082|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.22|STANDARD_ERROR_OF_MEAN|3.27||0.4979|TWO_SIDED|90.0|-7.63|3.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.19|-7.63|0.4979
74021284|NCT03417440|147595464|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_DEVIATION|4.5||0.23|ONE_SIDED|90.0|-0.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.5|0.23
74021285|NCT03417440|147595465|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|1.1||0.78|ONE_SIDED|90.0|-0.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.5|0.78
74021286|NCT03417440|147595465|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.1||0.98|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.98
74021287|NCT03417440|147595465|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.1||0.13|ONE_SIDED|90.0|-0.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.1|0.13
74021288|NCT03417440|147595466|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|4.3||0.285|ONE_SIDED|90.0||0.6||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||0.6||0.285
74021289|NCT03417440|147595466|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|4.3||0.5|ONE_SIDED|90.0||1.1||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||1.1||0.50
74021290|NCT03417440|147595466|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|4.3||0.92|ONE_SIDED|90.0||2.3||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||2.3||0.92
74021291|NCT03417440|147595467|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|4.2||0.42|ONE_SIDED|90.0|-0.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.9|0.42
74021292|NCT03417440|147595467|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.2||0.82|ONE_SIDED|90.0|-1.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.9|0.82
74021293|NCT03417440|147595467|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|4.2||0.58|ONE_SIDED|90.0|-1.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.2|0.58
74021294|NCT03417440|147595468|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|4.0||0.45|ONE_SIDED|90.0|-0.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.9|0.45
74021295|NCT03417440|147595468|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|3.9||0.49|ONE_SIDED|90.0|-1.0|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.0|0.49
74021296|NCT03417440|147595468|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|3.9||0.61|ONE_SIDED|90.0|-1.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.2|0.61
74021297|NCT03417440|147595469|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||.84
74021298|NCT03417440|147595469|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
74021299|NCT03417440|147595469|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||.41
74021300|NCT03417440|147595470|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||.13
74021301|NCT03417440|147595470|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
74021302|NCT03417440|147595470|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.39
74021303|NCT03417440|147595471|OTHER||Spearman Correlation|-0.10435||||0.3116|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Self-efficacy for Physical Activity change and Daily Steps change across 4 months.||||0.3116
74021304|NCT03417440|147595471|OTHER||Spearman Correlation|0.17742||||0.0838|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Correlation between Self-regulation of Physical Activity change and Daily Steps change across 4 months.||||0.0838
74021305|NCT03417440|147595471|OTHER||Spearman Correlation|-0.09834||||0.351|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Family Social Support for Physical Activity change and Daily Steps change across 4 months.||||0.3510
74081083|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-3.45|STANDARD_ERROR_OF_MEAN|3.27||0.2927|TWO_SIDED|90.0|-8.85|1.95||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.95|-8.85|0.2927
74081084|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.83|STANDARD_ERROR_OF_MEAN|3.28||0.143|TWO_SIDED|90.0|-10.26|0.6||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||0.60|-10.26|0.1430
74081085|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.25|STANDARD_ERROR_OF_MEAN|3.73||0.7373|TWO_SIDED|90.0|-7.42|4.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.92|-7.42|0.7373
74081086|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.46|STANDARD_ERROR_OF_MEAN|3.7||0.5075|TWO_SIDED|90.0|-8.57|3.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||3.66|-8.57|0.5075
74081087|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.81|STANDARD_ERROR_OF_MEAN|3.74||0.6295|TWO_SIDED|90.0|-7.99|4.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.37|-7.99|0.6295
74081088|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.15|STANDARD_ERROR_OF_MEAN|3.95||0.4266|TWO_SIDED|90.0|-3.39|9.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.69|-3.39|0.4266
74081089|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.96|STANDARD_ERROR_OF_MEAN|3.89||0.2038|TWO_SIDED|90.0|-1.47|11.4||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.40|-1.47|0.2038
74081090|NCT02554877|147714166|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.29|STANDARD_ERROR_OF_MEAN|3.92||0.5592|TWO_SIDED|90.0|-4.19|8.78||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.78|-4.19|0.5592
74081091|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.09|||||TWO_SIDED|90.0|-5.86|16.05||||||Placebo was the reference and each of the active doses was the test for Week 2.||16.05|-5.86|
74081092|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.86|||||TWO_SIDED|90.0|-9.76|15.48||||||Placebo was the reference and each of the active doses was the test for Week 2.||15.48|-9.76|
74081093|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.13|||||TWO_SIDED|90.0|3.91|30.34||||||Placebo was the reference and each of the active doses was the test for Week 2.||30.34|3.91|
74081094|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.71|||||TWO_SIDED|90.0|-10.8|16.22||||||Placebo was the reference and each of the active doses was the test for Week 4.||16.22|-10.80|
74081095|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.92|||||TWO_SIDED|90.0|-10.61|16.45||||||Placebo was the reference and each of the active doses was the test for Week 4.||16.45|-10.61|
74081096|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.57|||||TWO_SIDED|90.0|-15.08|9.94||||||Placebo was the reference and each of the active doses was the test for Week 4.||9.94|-15.08|
74081097|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.63|||||TWO_SIDED|90.0|-16.29|13.03||||||Placebo was the reference and each of the active doses was the test for Week 8.||13.03|-16.29|
74081098|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.59|||||TWO_SIDED|90.0|-20.4|11.22||||||Placebo was the reference and each of the active doses was the test for Week 8.||11.22|-20.40|
74081099|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.75|||||TWO_SIDED|90.0|-13.66|19.16||||||Placebo was the reference and each of the active doses was the test for Week 8.||19.16|-13.66|
74081100|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.86|||||TWO_SIDED|90.0|-3.3|19.02||||||Placebo was the reference and each of the active doses was the test for Week 12.||19.02|-3.30|
74081101|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.13|||||TWO_SIDED|90.0|-16.13|13.87||||||Placebo was the reference and each of the active doses was the test for Week 12.||13.87|-16.13|
74081102|NCT02554877|147714167|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.99|||||TWO_SIDED|90.0|-7.07|19.04||||||Placebo was the reference and each of the active doses was the test for Week 12.||19.04|-7.07|
74081103|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.04|STANDARD_ERROR_OF_MEAN|2.52||0.68|TWO_SIDED|90.0|-3.12|5.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||5.20|-3.12|0.6800
74081104|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.64|STANDARD_ERROR_OF_MEAN|2.52||0.515|TWO_SIDED|90.0|-2.52|5.8||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||5.80|-2.52|0.5150
74081105|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.66|STANDARD_ERROR_OF_MEAN|2.53||0.0676|TWO_SIDED|90.0|0.47|8.85||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.85|0.47|0.0676
74081106|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.62|STANDARD_ERROR_OF_MEAN|2.48||0.8021|TWO_SIDED|90.0|-4.73|3.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.48|-4.73|0.8021
74081107|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.95|STANDARD_ERROR_OF_MEAN|2.49||0.4346|TWO_SIDED|90.0|-6.06|2.16||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.16|-6.06|0.4346
74021306|NCT03417440|147595471|OTHER||Spearman Correlation|-0.04562||||0.6659|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Outcome Expectation for Physical Activity change and Daily Steps change across 4 months.||||0.6659
74021307|NCT03417440|147595471|OTHER||Spearman Correlation|-0.04831||||0.6402|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Aging Self-perceptions (Attitude Toward Own Aging) change and Daily Steps change across 4 months.||||0.6402
74021308|NCT03417440|147595471|OTHER||Spearman Correlation|0.13128||||0.2048|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Psychosocial Loss change and Daily Steps change across 4 months.||||0.2048
74021309|NCT03417440|147595471|OTHER||Spearman Correlation|0.10022||||0.3445|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Physical Change change and Daily Steps change across 4 months.||||0.3445
74021310|NCT03417440|147595471|OTHER||Spearman Correlation|-0.00866||||0.934|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Psychological Growth change and Daily Steps change across 4 months.||||0.9340
74021311|NCT03304522|147595472|SUPERIORITY||Least Squares (LS) Mean Difference|-1.085|||<|0.0001|TWO_SIDED|95.0|-1.876|-0.293|||Mixed-effects Model for Repeated Measure|||||-0.293|-1.876|<0.0001
74081108|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.03|STANDARD_ERROR_OF_MEAN|2.49||0.4173|TWO_SIDED|90.0|-6.15|2.09||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.09|-6.15|0.4173
74081109|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.98|STANDARD_ERROR_OF_MEAN|2.56||0.7036|TWO_SIDED|90.0|-5.21|3.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||3.26|-5.21|0.7036
74081110|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.64|STANDARD_ERROR_OF_MEAN|2.54||0.2993|TWO_SIDED|90.0|-6.84|1.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.56|-6.84|0.2993
74021312|NCT03304522|147595475|SUPERIORITY||LS Mean Difference|-1.111|||<|0.0001|TWO_SIDED|95.0|-1.911|-0.312|||Mixed-effects Model for Repeated Measure|||||-0.312|-1.911|<0.0001
74021313|NCT03304522|147595477|SUPERIORITY||LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-1.5|0.3|||Mixed-effects Model for Repeated Measure|||||0.3|-1.5|<0.0001
74021314|NCT00885365|147595511|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority is shown if the lower limit of the two-sided 95% confidence interval is above the non-inferiority margin set at -4.5%.|difference of least square means|-0.5||||0.64|TWO_SIDED|95.0|-2.58|1.59|||ANCOVA|||Based on previous studies, the difference between reference and placebo after 4-week treatment is assumed to be about 12% and the non-inferiority margin safely placed at 4.5%. With a between-patient SD of 13.5% and estimated difference between treatments of zero, sample size of 143 per group allows a 80% power to show the non-inferiority of Bramitob® versus TOBI®. Accounting for an expected dropout rate of 11%, a minimum of 160 participants per group is required.||1.59|-2.58|0.640
74021315|NCT00885365|147595513|SUPERIORITY_OR_OTHER||difference of least square means|-0.01||||0.634|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|||Analysis for Week 4||0.05|-0.08|0.634
74021316|NCT00885365|147595514|SUPERIORITY_OR_OTHER||difference of least square means|-0.55||||0.63|TWO_SIDED|95.0|-2.78|1.69|||ANCOVA|||Analysis for Week 4||1.69|-2.78|0.630
74021317|NCT00885365|147595515|SUPERIORITY_OR_OTHER||difference of least square means|-0.02||||0.693|TWO_SIDED|95.0|-0.09|0.06|||ANCOVA|||Analysis for Week 4||0.06|-0.09|0.693
74021318|NCT00885365|147595516|SUPERIORITY_OR_OTHER||difference of least square means|0.51||||0.777|TWO_SIDED|95.0|-3.06|4.09|||ANCOVA|||Analysis for Week 4||4.09|-3.06|0.777
74021319|NCT00885365|147595517|SUPERIORITY_OR_OTHER||difference of least square means|0.04||||0.505|TWO_SIDED|95.0|-0.08|0.15|||ANCOVA|||Analysis for Week 4||0.15|-0.08|0.505
74021320|NCT00885365|147595518|SUPERIORITY_OR_OTHER||difference of least square means|0.04|STANDARD_ERROR_OF_MEAN|0.18||0.82|TWO_SIDED|95.0|-0.31|0.39||A priori threshold for statistical significance is \<= 0.050.|ANCOVA|treatment and country are fixed effects and baseline log10 bacterial load (CFU/g) value is a covariate||Analysis of Week 4 data||0.39|-0.31|0.820
74081111|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.08|STANDARD_ERROR_OF_MEAN|2.57||0.9751|TWO_SIDED|90.0|-4.16|4.32||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.32|-4.16|0.9751
74081112|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.23|STANDARD_ERROR_OF_MEAN|2.86||0.1408|TWO_SIDED|90.0|-0.5|8.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.96|-0.50|0.1408
74081113|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.7|STANDARD_ERROR_OF_MEAN|2.83||0.0986|TWO_SIDED|90.0|0.02|9.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.38|0.02|0.0986
74081114|NCT02554877|147714168|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.79|STANDARD_ERROR_OF_MEAN|2.85||0.1851|TWO_SIDED|90.0|-0.92|8.5||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.50|-0.92|0.1851
73836828|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.17|5.85||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||5.85|0.17|
74081115|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.39|STANDARD_ERROR_OF_MEAN|2.17||0.8559|TWO_SIDED|90.0|-3.19|3.98||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||3.98|-3.19|0.8559
74021321|NCT00885365|147595521|SUPERIORITY_OR_OTHER|||||||0.692||||||A priori threshold for statistical significance is \<= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 4||||0.692
74021322|NCT00885365|147595521|SUPERIORITY_OR_OTHER|||||||0.128||||||A priori threshold for statistical significance is \<= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 8||||0.128
74021323|NCT02706938|147595526|OTHER|One tail paired t test.|Mean Difference (Final Values)|1.3267|STANDARD_DEVIATION|2.1604||0.0002|TWO_SIDED|95.0|0.6263|2.027||A priori threshold for statistical significance was 0.05|t-test, 1 sided|||||2.0270|0.6263|0.0002
74021324|NCT02706938|147595526|OTHER|McNemar's chi squared statistic|Risk Difference (RD)|-0.359||||0.0082|TWO_SIDED|95.0|-0.6255|-0.0924||A priori threshold for statistical significance was 0.05|McNemar|||||-0.0924|-0.6255|0.0082
74021325|NCT02706938|147595527|OTHER|One tail paired t test.|Mean Difference (Final Values)|-6.9131|STANDARD_DEVIATION|32.5093||0.099|TWO_SIDED|95.0|-17.5987|3.7724||A priori threshold for statistical significance was 0.05|t-test, 1 sided|||||3.7724|-17.5987|0.099
74021326|NCT02706938|147595527|OTHER|McNemar's chi squared statistic|Risk Difference (RD)|-0.0263||||0.8084|TWO_SIDED|95.0|-0.2651|0.2125||A priori threshold for statistical significance was 0.05|McNemar|||||0.2125|-0.2651|0.8084
74021327|NCT00813995|147595537|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparison|ANCOVA|||||||<.001
74021328|NCT02507349|147595542|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Time-by-treatment interaction||||<0.0001
74081116|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.97|STANDARD_ERROR_OF_MEAN|2.17||0.1729|TWO_SIDED|90.0|-0.62|6.55||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.55|-0.62|0.1729
73836829|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.15|3.72||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.72|0.15|
74021329|NCT02507349|147595542|SUPERIORITY|||||||0.0033|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49.||||0.0033
74021330|NCT02507349|147595542|SUPERIORITY|||||||0.3164|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.||||0.3164
74021331|NCT02507349|147595542|SUPERIORITY|||||||0.0482|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)||||0.0482
74021332|NCT02507349|147595542|SUPERIORITY|||||||0.9928|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)||||0.9928
74021333|NCT02507349|147595543|SUPERIORITY|||||||0.6243|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.6243
74021334|NCT02507349|147595543|SUPERIORITY|||||||0.1969|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.1969
74021335|NCT02507349|147595543|SUPERIORITY|||||||0.0042|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49||||0.0042
74021336|NCT02507349|147595543|SUPERIORITY|||||||0.0002|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.||||0.0002
74021337|NCT02507349|147595543|SUPERIORITY|||||||0.7254|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)||||0.7254
74021338|NCT02507349|147595543|SUPERIORITY|||||||0.058|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)||||0.0580
74021339|NCT02507349|147595544|SUPERIORITY|||||||0.4677|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.4677
74081117|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|8.45|STANDARD_ERROR_OF_MEAN|2.18||0.0002|TWO_SIDED|90.0|4.84|12.06||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||12.06|4.84|0.0002
74021340|NCT02507349|147595544|SUPERIORITY|||||||0.094|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0940
74021341|NCT02507349|147595545|SUPERIORITY|||||||0.8733|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.8733
74021342|NCT02507349|147595545|SUPERIORITY|||||||0.0113|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0113
74021343|NCT02507349|147595546|SUPERIORITY|||||||0.2328|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.2328
74021344|NCT02507349|147595546|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0005
74021345|NCT02507349|147595547|SUPERIORITY|||||||0.0033|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.0033
74021346|NCT02507349|147595548|SUPERIORITY|||||||0.1649|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.1649
74021347|NCT02507349|147595548|SUPERIORITY|||||||0.0016|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0016
74021348|NCT02507349|147595549|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.0080
74021349|NCT02507349|147595550|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74021350|NCT02507349|147595551|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
74021351|NCT03618030|147595552|OTHER|||||||0.0003|||||||ANOVA|||The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom PERMP-T scores.||||.0003
74021352|NCT00860470|147595553|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.95||||0.36|TWO_SIDED|95.0|0.86|1.06|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.06|0.86|0.36
74021353|NCT00860470|147595554|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.78|TWO_SIDED|95.0|0.88|1.2|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.20|0.88|0.78
74021354|NCT00860470|147595555|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.81||||0.11|TWO_SIDED|95.0|0.63|1.04|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.04|0.63|0.11
74081118|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.37|STANDARD_ERROR_OF_MEAN|2.55||0.8837|TWO_SIDED|90.0|-3.85|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||4.59|-3.85|0.8837
74021355|NCT00860470|147595556|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.89||||0.02|TWO_SIDED|95.0|0.81|0.99|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.99|0.81|0.02
74021356|NCT00860470|147595557|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.91|0.80|<0.001
74021357|NCT00860470|147595558|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.75||||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.97|0.57|0.03
74021358|NCT00860470|147595559|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.73|||<|0.001|TWO_SIDED|95.0|0.62|0.86|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.86|0.62|<0.001
74021359|NCT00860470|147595560|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.87||||0.87|TWO_SIDED|95.0|0.81|0.93|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.93|0.81|0.87
74021360|NCT00860470|147595561|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88|||<|0.001|TWO_SIDED|95.0|0.85|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.91|0.85|<0.001
74021361|NCT00860470|147595562|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.13|TWO_SIDED|95.0|0.96|1.01|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.01|0.96|0.13
74021362|NCT01748799|147595589|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The level for statistical significance was p\< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Scale (CWS) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p\< 0.05.||||<0.01
74021363|NCT01748799|147595589|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||The level for statistical significance was p\< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Checklist (CWC) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p\< 0.05.||||0.01
74021364|NCT00473876|147595594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.08||95.0|||||t-test, 1 sided|The differences between baseline and post-intervention (4 months) was analyzed using independent t-test, comparing metformin and placebo.||Null hypothesis: Metformin has no effect on peak VO2. We targetted 66 subjects and power calculation based on our previous observational study of CHF with insulin resistance with mean peak VO2 of 11.||||0.08
74021365|NCT00473876|147595595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.45|STANDARD_DEVIATION|10.72||0.034||95.0|||||t-test, 1 sided|Compare between metformin and placebo arm.||Null hypothesis: Metformin has no effect on the ratio between VCO2 (production of CO2) and VE (ventilation), it is also called the VE/VCO2 slope||||0.034
74021366|NCT00348140|147595596|SUPERIORITY||Mean Difference (Net)|0.3||||0.739|TWO_SIDED|95.0|-1.2|1.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||1.8|-1.2|0.739
74021367|NCT00348140|147595596|SUPERIORITY||Mean Difference (Net)|0.8||||0.343|TWO_SIDED|95.0|-0.8|2.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||2.4|-0.8|0.343
74021368|NCT00348140|147595597|SUPERIORITY||Mean Difference (Net)|-0.1||||0.783|TWO_SIDED|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.9|-1.1|0.783
74021369|NCT00348140|147595597|SUPERIORITY||Mean Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-1.1|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||1.1|-1.1|0.940
74021370|NCT00348140|147595598|SUPERIORITY||Mean Difference (Net)|-0.1|||=|0.763|TWO_SIDED|95.0|-1.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.8|-1.1|=0.763
74021371|NCT00348140|147595598|SUPERIORITY||Mean Difference (Net)|-0.1|||=|0.8|TWO_SIDED|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.9|-1.1|=0.800
74021372|NCT00348140|147595599|SUPERIORITY||Mean Difference (Net)|-0.1||||0.611|TWO_SIDED|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.4|-0.7|0.611
74021373|NCT00348140|147595599|SUPERIORITY||Mean Difference (Net)|-0.1||||0.741|TWO_SIDED|95.0|-0.6|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.4|-0.6|0.741
74021374|NCT00348140|147595600|SUPERIORITY||Mean Difference (Net)|0.0||||0.913|TWO_SIDED|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.3|-0.4|0.913
74021375|NCT00348140|147595600|SUPERIORITY||Mean Difference (Net)|-0.1||||0.481|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.5|0.481
74021376|NCT00348140|147595601|SUPERIORITY||Mean Difference (Net)|-0.1||||0.557|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.4|0.557
74021377|NCT00348140|147595601|SUPERIORITY||Mean Difference (Net)|-0.1||||0.404|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.5|0.404
74021378|NCT00348140|147595602|SUPERIORITY||Mean Difference (Net)|0.1||||0.633|TWO_SIDED|95.0|-0.5|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.8|-0.5|0.633
74021379|NCT00348140|147595602|SUPERIORITY||Mean Difference (Net)|0.2||||0.575|TWO_SIDED|95.0|-0.4|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.8|-0.4|0.575
74021380|NCT00348140|147595602|SUPERIORITY||Mean Difference (Net)|0.1||||0.82|TWO_SIDED|95.0|-0.6|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.7|-0.6|0.820
74021381|NCT00348140|147595602|SUPERIORITY||Mean Difference (Net)|0.0||||0.908|TWO_SIDED|95.0|-0.7|0.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.6|-0.7|0.908
74021382|NCT00348140|147595602|SUPERIORITY||Mean Difference (Net)|0.4||||0.292|TWO_SIDED|95.0|-0.3|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||1.1|-0.3|0.292
74081119|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.62|STANDARD_ERROR_OF_MEAN|2.55||0.1573|TWO_SIDED|90.0|-0.6|7.84||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||7.84|-0.60|0.1573
74021383|NCT00348140|147595602|SUPERIORITY||Mean Difference (Net)|0.0||||0.978|TWO_SIDED|95.0|-0.7|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.7|-0.7|0.978
74021384|NCT00348140|147595602|SUPERIORITY||Mean Difference (Net)|0.2||||0.691|TWO_SIDED|95.0|-0.6|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||1.0|-0.6|0.691
74021385|NCT00348140|147595602|SUPERIORITY||Mean Difference (Net)|-0.1||||0.849|TWO_SIDED|95.0|-0.9|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.8|-0.9|0.849
74021386|NCT00348140|147595603|SUPERIORITY||Mean Difference (Net)|0.0||||0.938|TWO_SIDED|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12||0.2|-0.2|0.938
74021387|NCT00348140|147595603|SUPERIORITY||Mean Difference (Net)|0.0||||0.887|TWO_SIDED|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12||0.2|-0.2|0.887
74021388|NCT00348140|147595603|SUPERIORITY||Mean Difference (Net)|-0.1||||0.465|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.2|-0.4|0.465
74021389|NCT00348140|147595603|SUPERIORITY||Mean Difference (Net)|0.1||||0.596|TWO_SIDED|95.0|-0.2|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.3|-0.2|0.596
74021390|NCT00348140|147595603|SUPERIORITY||Mean Difference (Net)|-0.1||||0.452|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.2|-0.4|0.452
74081120|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|7.88|STANDARD_ERROR_OF_MEAN|2.56||0.0024|TWO_SIDED|90.0|3.65|12.11||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||12.11|3.65|0.0024
74081121|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.59|STANDARD_ERROR_OF_MEAN|2.51||0.1538|TWO_SIDED|90.0|-0.55|7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||7.73|-0.55|0.1538
74021391|NCT00348140|147595603|SUPERIORITY||Mean Difference (Net)|-0.1||||0.429|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.2|-0.4|0.429
74021392|NCT00348140|147595604|SUPERIORITY||Mean Difference (Net)|-0.3||||0.386|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.386
74021393|NCT00348140|147595604|SUPERIORITY||Mean Difference (Net)|0.0||||0.999|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.999
74021394|NCT00348140|147595605|SUPERIORITY||Mean Difference (Net)|1.1||||0.09|TWO_SIDED|95.0|-0.2|2.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||2.5|-0.2|0.090
74021395|NCT00348140|147595605|SUPERIORITY||Mean Difference (Net)|0.0||||0.957|TWO_SIDED|95.0|-1.3|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||1.3|-1.3|0.957
74021396|NCT00348140|147595605|SUPERIORITY||Mean Difference (Net)|0.7||||0.395|TWO_SIDED|95.0|-0.9|2.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||2.2|-0.9|0.395
74021397|NCT00348140|147595605|SUPERIORITY||Mean Difference (Net)|-0.9||||0.275|TWO_SIDED|95.0|-2.5|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.7|-2.5|0.275
74021398|NCT00348140|147595605|SUPERIORITY||Mean Difference (Net)|1.7||||0.039|TWO_SIDED|95.0|0.1|3.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||3.4|0.1|0.039
74081122|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.39|STANDARD_ERROR_OF_MEAN|2.48||0.0789|TWO_SIDED|90.0|0.28|8.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||8.49|0.28|0.0789
74021399|NCT00348140|147595605|SUPERIORITY||Mean Difference (Net)|-0.1||||0.895|TWO_SIDED|95.0|-1.8|1.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||1.6|-1.8|0.895
74021400|NCT00348140|147595605|SUPERIORITY||Mean Difference (Net)|0.1||||0.914|TWO_SIDED|95.0|-2.1|2.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||2.3|-2.1|0.914
74021401|NCT00348140|147595605|SUPERIORITY||Mean Difference (Net)|-0.9||||0.43|TWO_SIDED|95.0|-3.2|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||1.3|-3.2|0.430
74021402|NCT00348140|147595606|SUPERIORITY||Mean Difference (Net)|-0.2||||0.583|TWO_SIDED|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8||0.6|-1.1|0.583
74021403|NCT00348140|147595606|SUPERIORITY||Mean Difference (Net)|-0.2||||0.631|TWO_SIDED|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8||0.6|-1.1|0.631
74021404|NCT00348140|147595606|SUPERIORITY||Mean Difference (Net)|0.1||||0.812|TWO_SIDED|95.0|-0.8|1.1|||Mixed model for repeated measures|||For Week 16||1.1|-0.8|0.812
74021405|NCT00348140|147595606|SUPERIORITY||Mean Difference (Net)|0.0||||0.952|TWO_SIDED|95.0|-0.9|1.0|||Mixed model for repeated measures|||For Week 16||1.0|-0.9|0.952
74021406|NCT00348140|147595606|SUPERIORITY||Mean Difference (Net)|-0.9||||0.117|TWO_SIDED|95.0|-2.1|0.2|||Mixed model for repeated measures|||For Week 24||0.2|-2.1|0.117
74021407|NCT00348140|147595606|SUPERIORITY||Mean Difference (Net)|-1.0||||0.074|TWO_SIDED|95.0|-2.1|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.1|-2.1|0.074
74021408|NCT00348140|147595606|SUPERIORITY||Mean Difference (Net)|-1.0||||0.141|TWO_SIDED|95.0|-2.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.3|-2.4|0.141
74021409|NCT00348140|147595606|SUPERIORITY||Mean Difference (Net)|-0.7||||0.331|TWO_SIDED|95.0|-2.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.7|-2.1|0.331
74021410|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|4.1||||0.251|TWO_SIDED|95.0|-2.9|11.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12||11.2|-2.9|0.251
74021411|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|5.9||||0.113|TWO_SIDED|95.0|-1.4|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12||13.2|-1.4|0.113
74081123|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|10.14|STANDARD_ERROR_OF_MEAN|2.51|<|0.0001|TWO_SIDED|90.0|5.98|14.3||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||14.30|5.98|<0.0001
74021412|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|1.6||||0.723|TWO_SIDED|95.0|-7.1|10.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24||10.2|-7.1|0.723
74021413|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|3.5||||0.482|TWO_SIDED|95.0|-6.3|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24||13.2|-6.3|0.482
74021414|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|1.5||||0.785|TWO_SIDED|95.0|-9.5|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36||12.6|-9.5|0.785
74021415|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|2.2||||0.711|TWO_SIDED|95.0|-9.4|13.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36||13.8|-9.4|0.711
74021416|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|4.0||||0.484|TWO_SIDED|95.0|-7.2|15.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48||15.2|-7.2|0.484
74021417|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|3.4||||0.572|TWO_SIDED|95.0|-8.5|15.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48||15.4|-8.5|0.572
74021418|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|6.8||||0.197|TWO_SIDED|95.0|-3.6|17.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12||17.3|-3.6|0.197
74021419|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|7.4||||0.183|TWO_SIDED|95.0|-3.5|18.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12||18.4|-3.5|0.183
74021420|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|10.0||||0.121|TWO_SIDED|95.0|-2.6|22.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24||22.6|-2.6|0.121
74021421|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|6.8||||0.291|TWO_SIDED|95.0|-5.8|19.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24||19.3|-5.8|0.291
74021422|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|7.0||||0.389|TWO_SIDED|95.0|-8.9|22.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36||22.9|-8.9|0.389
74021423|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|-1.2||||0.865|TWO_SIDED|95.0|-15.0|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36||12.6|-15.0|0.865
74021424|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|4.2||||0.596|TWO_SIDED|95.0|-11.3|19.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48||19.6|-11.3|0.596
74021425|NCT00348140|147595607|SUPERIORITY||Mean Difference (Net)|-0.2||||0.975|TWO_SIDED|95.0|-14.7|14.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48||14.2|-14.7|0.975
74021426|NCT00348140|147595608|SUPERIORITY||Mean Difference (Net)|-2.4||||0.043|TWO_SIDED|95.0|-4.7|-0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12||-0.1|-4.7|0.043
74021427|NCT00348140|147595608|SUPERIORITY||Mean Difference (Net)|-2.2||||0.056|TWO_SIDED|95.0|-4.5|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12||0.1|-4.5|0.056
74021428|NCT00348140|147595608|SUPERIORITY||Mean Difference (Net)|-0.4||||0.758|TWO_SIDED|95.0|-2.8|2.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36||2.1|-2.8|0.758
74021429|NCT00348140|147595608|SUPERIORITY||Mean Difference (Net)|-2.0||||0.109|TWO_SIDED|95.0|-4.5|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36||0.5|-4.5|0.109
74021430|NCT00348140|147595608|SUPERIORITY||Mean Difference (Net)|-2.6||||0.05|TWO_SIDED|95.0|-5.2|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48||-0.0|-5.2|0.050
74021431|NCT00348140|147595608|SUPERIORITY||Mean Difference (Net)|-3.4||||0.009|TWO_SIDED|95.0|-6.0|-0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48||-0.9|-6.0|0.009
74021432|NCT00348140|147595609|SUPERIORITY||Mean Difference (Net)|0.01||||0.662|TWO_SIDED|95.0|-0.02|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12||0.03|-0.02|0.662
74021433|NCT00348140|147595609|SUPERIORITY||Mean Difference (Net)|-0.01||||0.503|TWO_SIDED|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12||0.02|-0.03|0.503
74081124|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|6.96|STANDARD_ERROR_OF_MEAN|2.78||0.0132|TWO_SIDED|90.0|2.36|11.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.56|2.36|0.0132
74021434|NCT00348140|147595609|SUPERIORITY||Mean Difference (Net)|0.0||||0.892|TWO_SIDED|95.0|-0.03|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36||0.03|-0.03|0.892
74021435|NCT00348140|147595609|SUPERIORITY||Mean Difference (Net)|-0.03||||0.083|TWO_SIDED|95.0|-0.05|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36||0.00|-0.05|0.083
74021436|NCT00348140|147595609|SUPERIORITY||Mean Difference (Net)|-0.01||||0.366|TWO_SIDED|95.0|-0.05|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48||0.02|-0.05|0.366
74021437|NCT00348140|147595609|SUPERIORITY||Mean Difference (Net)|0.0||||0.769|TWO_SIDED|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48||0.02|-0.03|0.769
74021438|NCT00348140|147595610|SUPERIORITY||Mean Difference (Net)|-0.2||||0.529|TWO_SIDED|95.0|-0.7|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12||0.3|-0.7|0.529
74021439|NCT00348140|147595610|SUPERIORITY||Mean Difference (Net)|-0.1||||0.62|TWO_SIDED|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12||0.4|-0.7|0.620
73898156|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.074||0.176|TWO_SIDED|95.0|-0.245|0.045||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.045|-0.245|0.176
74021440|NCT00348140|147595610|SUPERIORITY||Mean Difference (Net)|-0.4||||0.284|TWO_SIDED|95.0|-1.0|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36||0.3|-1.0|0.284
74021441|NCT00348140|147595610|SUPERIORITY||Mean Difference (Net)|0.2||||0.488|TWO_SIDED|95.0|-0.4|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36||0.9|-0.4|0.488
74021442|NCT00348140|147595610|SUPERIORITY||Mean Difference (Net)|0.2||||0.549|TWO_SIDED|95.0|-0.5|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 48||1.0|-0.5|0.549
74021443|NCT00348140|147595610|SUPERIORITY||Mean Difference (Net)|0.1||||0.78|TWO_SIDED|95.0|-0.6|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.9|-0.6|0.780
74021444|NCT00348140|147595611|SUPERIORITY||Mean Difference (Net)|-0.6||||0.106|TWO_SIDED|95.0|-1.3|0.1|||ANCOVA|||||0.1|-1.3|0.106
74021445|NCT00348140|147595611|SUPERIORITY||Mean Difference (Net)|-0.4||||0.229|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||||0.3|-1.2|0.229
74021446|NCT00348140|147595612|SUPERIORITY||Mean Difference (Net)|-0.1||||0.324|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.324
73898157|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|0.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898158|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.072||0.125|TWO_SIDED|95.0|-0.251|0.031||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.031|-0.251|0.125
73898159|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|0.21|STANDARD_DEVIATION|0.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898160|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.074||0.676|TWO_SIDED|95.0|-0.176|0.114||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||week 48||0.114|-0.176|0.676
73898161|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898162|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.095||0.226|TWO_SIDED|95.0|-0.301|0.071||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.071|-0.301|0.226
74021447|NCT00348140|147595612|SUPERIORITY||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.987
74021448|NCT00348140|147595613|SUPERIORITY||Mean Difference (Net)|0.05||||0.038|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||||0.10|0.00|0.038
74081125|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|7.41|STANDARD_ERROR_OF_MEAN|2.75||0.0079|TWO_SIDED|90.0|2.85|11.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.96|2.85|0.0079
74021449|NCT00348140|147595613|SUPERIORITY||Mean Difference (Net)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.18|||ANCOVA|||||0.18|0.08|<0.001
74021450|NCT00348140|147595626|SUPERIORITY||Mean Difference (Net)|-0.1||||0.748|TWO_SIDED|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.3|-0.4|0.748
74021451|NCT00348140|147595626|SUPERIORITY||Mean Difference (Net)|0.1||||0.617|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.5|-0.3|0.617
74021452|NCT00348140|147595626|SUPERIORITY||Mean Difference (Net)|-0.1||||0.708|TWO_SIDED|95.0|-0.5|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16||0.3|-0.5|0.708
74021453|NCT00348140|147595626|SUPERIORITY||Mean Difference (Net)|-0.2||||0.4|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16||0.2|-0.5|0.400
74021454|NCT00348140|147595626|SUPERIORITY||Mean Difference (Net)|0.0||||0.928|TWO_SIDED|95.0|-0.4|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.4|-0.4|0.928
74021455|NCT00348140|147595626|SUPERIORITY||Mean Difference (Net)|0.3||||0.178|TWO_SIDED|95.0|-0.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.7|-0.1|0.178
74021456|NCT00348140|147595626|SUPERIORITY||Mean Difference (Net)|0.1||||0.626|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.5|-0.3|0.626
74021457|NCT00348140|147595626|SUPERIORITY||Mean Difference (Net)|0.1||||0.608|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.5|-0.3|0.608
74021458|NCT00348140|147595626|SUPERIORITY||Mean Difference (Net)|0.0||||0.865|TWO_SIDED|95.0|-0.5|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.4|-0.5|0.865
74021459|NCT00348140|147595626|SUPERIORITY||Mean Difference (Net)|0.3||||0.149|TWO_SIDED|95.0|-0.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.8|-0.1|0.149
74081126|NCT02554877|147714169|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|10.83|STANDARD_ERROR_OF_MEAN|2.77||0.0001|TWO_SIDED|90.0|6.24|15.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||15.42|6.24|0.0001
74081127|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.46|STANDARD_ERROR_OF_MEAN|3.31||0.6597|TWO_SIDED|90.0|-4.01|6.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.92|-4.01|0.6597
74021460|NCT00516919|147595627|SUPERIORITY_OR_OTHER_LEGACY||F statistic|0.45|||=|0.51||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at post-treatment, controlling for baseline BMI.||||=0.51
74021461|NCT00516919|147595627|SUPERIORITY_OR_OTHER_LEGACY||F statistic|0.69|||=|0.41||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at 6-month follow-up, controlling for baseline BMI.||||=0.41
74021462|NCT03371355|147595628|SUPERIORITY||Mean Difference in % CFB|-24.0||||0.0343|TWO_SIDED|95.0|-41.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-2|-41|0.0343
74021463|NCT03371355|147595628|SUPERIORITY||Mean Difference in % CFB|-44.0|||<|0.0001|TWO_SIDED|95.0|-56.0|-28.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-28|-56|<0.0001
74021464|NCT03371355|147595628|SUPERIORITY||Mean Difference in % CFB|-37.0||||0.0009|TWO_SIDED|95.0|-52.0|-17.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-17|-52|0.0009
74021465|NCT03371355|147595629|SUPERIORITY||Least Squares Mean Difference|-49.87|||<|0.0001|TWO_SIDED|95.0|-62.68|-37.06|||ANCOVA|||||-37.06|-62.68|<0.0001
74021466|NCT03371355|147595629|SUPERIORITY||Least Squares Mean Difference|-71.66|||<|0.0001|TWO_SIDED|95.0|-84.47|-58.85|||ANCOVA|||||-58.85|-84.47|<0.0001
74021467|NCT03371355|147595629|SUPERIORITY||Least Squares Mean Difference|-59.74|||<|0.0001|TWO_SIDED|95.0|-74.04|-45.44|||ANCOVA|||||-45.44|-74.04|<0.0001
74021468|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-16.5||||0.0327|TWO_SIDED|95.0|-31.59|-1.39|||ANCOVA|||TC||-1.39|-31.59|0.0327
74021469|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-37.0|||<|0.0001|TWO_SIDED|95.0|-52.15|-21.94|||ANCOVA|||TC||-21.94|-52.15|<0.0001
74021470|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-31.6||||0.0003|TWO_SIDED|95.0|-48.23|-15.05|||ANCOVA|||TC||-15.05|-48.23|0.0003
74021471|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|7.5||||0.256|TWO_SIDED|95.0|-5.55|20.54|||ANCOVA|||LDL-C||20.54|-5.55|0.2560
74021472|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-8.6||||0.1795|TWO_SIDED|95.0|-21.26|4.05|||ANCOVA|||LDL-C||4.05|-21.26|0.1795
74021473|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-8.8||||0.2065|TWO_SIDED|95.0|-22.48|4.95|||ANCOVA|||LDL-C||4.95|-22.48|0.2065
73898163|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
74021474|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-2.7||||0.1515|TWO_SIDED|95.0|-6.43|1.01|||ANCOVA|||HDL-C||1.01|-6.43|0.1515
74021475|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.29|-4.91|||ANCOVA|||HDL-C||-4.91|-12.29|<0.0001
74021476|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-4.1||||0.0436|TWO_SIDED|95.0|-8.18|-0.12|||ANCOVA|||HDL-C||-0.12|-8.18|0.0436
74021477|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-9.1||||0.0224|TWO_SIDED|95.0|-16.94|-1.33|||ANCOVA|||VLDL-C||-1.33|-16.94|0.0224
74021478|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-15.4||||0.0001|TWO_SIDED|95.0|-22.94|-7.84|||ANCOVA|||VLDL-C||-7.84|-22.94|0.0001
74021479|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-10.8||||0.0091|TWO_SIDED|95.0|-18.86|-2.78|||ANCOVA|||VLDL-C||-2.78|-18.86|0.0091
74021480|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-13.9||||0.0748|TWO_SIDED|95.0|-29.12|1.42|||ANCOVA|||Non-HDL-C||1.42|-29.12|0.0748
74021481|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-28.4||||0.0004|TWO_SIDED|95.0|-43.68|-13.18|||ANCOVA|||Non-HDL-C||-13.18|-43.68|0.0004
74021482|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-27.4||||0.0016|TWO_SIDED|95.0|-44.08|-10.64|||ANCOVA|||Non-HDL-C||-10.64|-44.08|0.0016
74021483|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-2.44||||0.6005|TWO_SIDED|95.0|-11.68|6.8|||ANCOVA|||ApoB||6.80|-11.68|0.6005
74021484|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-9.83||||0.0374|TWO_SIDED|95.0|-19.07|-0.59|||ANCOVA|||ApoB||-0.59|-19.07|0.0374
74021485|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-5.28||||0.31|TWO_SIDED|95.0|-15.55|5.0|||ANCOVA|||ApoB||5.00|-15.55|0.3100
74021486|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-1.002||||0.0728|TWO_SIDED|95.0|-2.1|0.09|||ANCOVA|||ApoB-48||0.09|-2.10|0.0728
74021487|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-1.803||||0.0018|TWO_SIDED|95.0|-2.91|-0.69|||ANCOVA|||ApoB-48||-0.69|-2.91|0.0018
74021488|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-1.091||||0.0759|TWO_SIDED|95.0|-2.3|0.12|||ANCOVA|||ApoB-48||0.12|-2.30|0.0759
74021489|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-0.887||||0.8451|TWO_SIDED|95.0|-9.89|8.11|||ANCOVA|||ApoB-100||8.11|-9.89|0.8451
74021490|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-7.59||||0.0973|TWO_SIDED|95.0|-16.59|1.41|||ANCOVA|||ApoB-100||1.41|-16.59|0.0973
74021491|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-3.418||||0.5|TWO_SIDED|95.0|-13.45|6.61|||ANCOVA|||ApoB-100||6.61|-13.45|0.5000
74021492|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-4.753||||0.0008|TWO_SIDED|95.0|-7.47|-2.03|||ANCOVA|||ApoCIII||-2.03|-7.47|0.0008
74021493|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-8.499|||<|0.0001|TWO_SIDED|95.0|-11.18|-5.82|||ANCOVA|||ApoCIII||-5.82|-11.18|<0.0001
74021494|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-6.86|||<|0.0001|TWO_SIDED|95.0|-9.78|-3.93|||ANCOVA|||ApoCIII||-3.93|-9.78|<0.0001
74021495|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-16.8||||0.0003|TWO_SIDED|95.0|-25.8|-7.85|||ANCOVA|||ApoA1||-7.85|-25.80|0.0003
74021496|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-35.2|||<|0.0001|TWO_SIDED|95.0|-44.07|-26.24|||ANCOVA|||ApoA1||-26.24|-44.07|<0.0001
74021497|NCT03371355|147595630|SUPERIORITY||Least Squares Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-30.89|-11.39|||ANCOVA|||ApoA1||-11.39|-30.89|<0.0001
74021498|NCT03371355|147595631|SUPERIORITY||Least Squares Mean Difference|0.0128||||0.8299|TWO_SIDED|95.0|-0.1|0.13|||ANCOVA|||||0.13|-0.10|0.8299
74021499|NCT03371355|147595631|SUPERIORITY||Least Squares Mean Difference|-0.0144||||0.8102|TWO_SIDED|95.0|-0.13|0.1|||ANCOVA|||||0.10|-0.13|0.8102
74021500|NCT03371355|147595631|SUPERIORITY||Least Squares Mean Difference|-0.0146||||0.8223|TWO_SIDED|95.0|-0.14|0.11|||ANCOVA|||||0.11|-0.14|0.8223
74021501|NCT03371355|147595632|SUPERIORITY||Least Squares Mean Difference|7.8||||0.0604|TWO_SIDED|95.0|-0.35|16.02|||ANCOVA|||Lp(a)||16.02|-0.35|0.0604
74021502|NCT03371355|147595632|SUPERIORITY||Least Squares Mean Difference|1.6||||0.7048|TWO_SIDED|95.0|-6.61|9.74|||ANCOVA|||Lp(a)||9.74|-6.61|0.7048
74021503|NCT03371355|147595632|SUPERIORITY||Least Squares Mean Difference|-1.7||||0.7024|TWO_SIDED|95.0|-10.65|7.2|||ANCOVA|||Lp(a)||7.20|-10.65|0.7024
74021504|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-45.0|||<|0.0001|TWO_SIDED|95.0|-54.0|-33.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-33|-54|<0.0001
74021505|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-69.0|-54.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-54|-69|<0.0001
74021506|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-47.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-47|-66|<0.0001
74021507|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0309|TWO_SIDED|95.0|-16.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-1|-16|0.0309
74021508|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-19.0|||<|0.0001|TWO_SIDED|95.0|-26.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-12|-26|<0.0001
74021509|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-17.0|||<|0.0001|TWO_SIDED|95.0|-25.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-9|-25|<0.0001
74021510|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|6.0||||0.4016|TWO_SIDED|95.0|-7.0|21.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||21|-7|0.4016
74021511|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.2589|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||6|-18|0.2589
74021512|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-12.0||||0.0616|TWO_SIDED|95.0|-24.0|1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||1|-24|0.0616
74021513|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.1918|TWO_SIDED|95.0|-18.0|4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||4|-18|0.1918
74021514|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-24.0|||<|0.0001|TWO_SIDED|95.0|-32.0|-14.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||-14|-32|<0.0001
74021515|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.1132|TWO_SIDED|95.0|-21.0|3.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||3|-21|0.1132
74021516|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-24.0||||0.0177|TWO_SIDED|95.0|-40.0|-5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-5|-40|0.0177
74021517|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-38.0|||<|0.0001|TWO_SIDED|95.0|-51.0|-23.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-23|-51|<0.0001
74021518|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-30.0||||0.0033|TWO_SIDED|95.0|-45.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-12|-45|0.0033
74021519|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.0523|TWO_SIDED|95.0|-18.0|0.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||0|-18|0.0523
74021520|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-18.0||||0.0002|TWO_SIDED|95.0|-26.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-26|0.0002
74021521|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-19.0||||0.0004|TWO_SIDED|95.0|-28.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-28|0.0004
74021522|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.4204|TWO_SIDED|95.0|-12.0|5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||5|-12|0.4204
73836830|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.1|5.37||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.37|0.10|
74021523|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0441|TWO_SIDED|95.0|-16.0|0.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||0|-16|0.0441
74021524|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.1324|TWO_SIDED|95.0|-16.0|2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||2|-16|0.1324
74021525|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-29.0||||0.1009|TWO_SIDED|95.0|-53.0|7.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||7|-53|0.1009
74021526|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-52.0||||0.0005|TWO_SIDED|95.0|-68.0|-28.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||-28|-68|0.0005
74021527|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-21.0||||0.3004|TWO_SIDED|95.0|-50.0|24.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||24|-50|0.3004
74021528|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-2.0||||0.6135|TWO_SIDED|95.0|-10.0|7.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||7|-10|0.6135
74021529|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.1127|TWO_SIDED|95.0|-15.0|2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||2|-15|0.1127
74021530|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-5.0||||0.2576|TWO_SIDED|95.0|-14.0|4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||4|-14|0.2576
74021531|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-36.0||||0.0017|TWO_SIDED|95.0|-52.0|-16.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-16|-52|0.0017
74021532|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-68.0|-45.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-45|-68|<0.0001
74021533|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-47.0|||<|0.0001|TWO_SIDED|95.0|-61.0|-29.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-29|-61|<0.0001
74021534|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-11.0||||0.0193|TWO_SIDED|95.0|-20.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-2|-20|0.0193
74021535|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-26.0|||<|0.0001|TWO_SIDED|95.0|-33.0|-19.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-19|-33|<0.0001
74021536|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-14.0||||0.0063|TWO_SIDED|95.0|-23.0|-4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-4|-23|0.0063
74021537|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-2.0||||0.8873|TWO_SIDED|95.0|-21.0|23.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||23|-21|0.8873
74021538|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.4404|TWO_SIDED|95.0|-27.0|15.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||15|-27|0.4404
74021539|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB]|-1.0||||0.9665|TWO_SIDED|95.0|-22.0|27.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||27|-22|0.9665
74021540|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB]|-7.0||||0.4133|TWO_SIDED|95.0|-21.0|10.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||10|-21|0.4133
74021541|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB]|-6.0||||0.475|TWO_SIDED|95.0|-20.0|11.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||11|-20|0.4750
74021542|NCT03371355|147595633|SUPERIORITY||Mean Difference in % CFB]|-4.0||||0.6354|TWO_SIDED|95.0|-20.0|15.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||15|-20|0.6354
74021543|NCT03371355|147595634|SUPERIORITY||Least Squares Mean Difference|-17.2||||0.1799|TWO_SIDED|95.0|-42.53|8.1|||ANCOVA|||||8.10|-42.53|0.1799
74021544|NCT03371355|147595634|SUPERIORITY||Least Squares Mean Difference|13.8||||0.2867|TWO_SIDED|95.0|-11.83|39.49|||ANCOVA|||||39.49|-11.83|0.2867
74021545|NCT03371355|147595634|SUPERIORITY||Least Squares Mean Difference|2.2||||0.8812|TWO_SIDED|95.0|-26.78|31.14|||ANCOVA|||||31.14|-26.78|0.8812
74021546|NCT03371355|147595635|SUPERIORITY||Least Squares Mean Difference|-0.28||||0.3995|TWO_SIDED|95.0|-0.94|0.38|||ANCOVA|||||0.38|-0.94|0.3995
74021547|NCT03371355|147595635|SUPERIORITY||Least Squares Mean Difference|0.08||||0.8155|TWO_SIDED|95.0|-0.59|0.75|||ANCOVA|||||0.75|-0.59|0.8155
74021548|NCT03371355|147595635|SUPERIORITY||Least Squares Mean Difference|0.16||||0.6466|TWO_SIDED|95.0|-0.54|0.86|||ANCOVA|||||0.86|-0.54|0.6466
74021549|NCT03371355|147595636|SUPERIORITY||Least Squares Mean Difference|1.39||||0.7393|TWO_SIDED|95.0|-9.66|6.89|||ANCOVA|||||6.89|-9.66|0.7393
74021550|NCT03371355|147595636|SUPERIORITY||Least Squares Mean Difference|-0.13||||0.9744|TWO_SIDED|95.0|-8.45|8.18|||ANCOVA|||||8.18|-8.45|0.9744
74021551|NCT03371355|147595636|SUPERIORITY||Least Squares Mean Difference|3.58||||0.4477|TWO_SIDED|95.0|-5.75|12.91|||ANCOVA|||||12.91|-5.75|0.4477
74021552|NCT03371355|147595637|SUPERIORITY||Least Squares Mean Difference|-1.794||||0.471|TWO_SIDED|95.0|-6.72|3.14|||ANCOVA|||||3.14|-6.72|0.4710
74021553|NCT03371355|147595637|SUPERIORITY||Least Squares Mean Difference|0.26||||0.9169|TWO_SIDED|95.0|-4.68|5.2|||ANCOVA|||||5.20|-4.68|0.9169
74021554|NCT03371355|147595637|SUPERIORITY||Least Squares Mean Difference|2.133||||0.4484|TWO_SIDED|95.0|-3.44|7.7|||ANCOVA|||||7.70|-3.44|0.4484
74021555|NCT03371355|147595638|SUPERIORITY||Least Squares Mean Difference|-23.2||||0.0916|TWO_SIDED|95.0|-50.17|3.83|||ANCOVA|||||3.83|-50.17|0.0916
74021556|NCT03371355|147595638|SUPERIORITY||Least Squares Mean Difference|-11.4||||0.4032|TWO_SIDED|95.0|-38.51|15.63|||ANCOVA|||||15.63|-38.51|0.4032
74021557|NCT03371355|147595638|SUPERIORITY||Least Squares Mean Difference|1.9||||0.8959|TWO_SIDED|95.0|-27.56|31.45|||ANCOVA|||||31.45|-27.56|0.8959
74021558|NCT03371355|147595639|SUPERIORITY||Least Squares Mean Difference|-0.052||||0.3202|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||||0.05|-0.16|0.3202
74021559|NCT03371355|147595639|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.8485|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||||0.09|-0.11|0.8485
74021560|NCT03371355|147595639|SUPERIORITY||Least Squares Mean Difference|0.0314||||0.5812|TWO_SIDED|95.0|-0.08|0.14|||ANCOVA|||||0.14|-0.08|0.5812
74021561|NCT03371355|147595640|SUPERIORITY||Least Squares Mean Difference|0.43||||0.6157|TWO_SIDED|95.0|-1.28|2.15|||ANCOVA|||||2.15|-1.28|0.6157
74021562|NCT03371355|147595640|SUPERIORITY||Least Squares Mean Difference|0.01||||0.9869|TWO_SIDED|95.0|-1.66|1.69|||ANCOVA|||||1.69|-1.66|0.9869
74021563|NCT03371355|147595640|SUPERIORITY||Least Squares Mean Difference|-0.33||||0.7084|TWO_SIDED|95.0|-2.07|1.42|||ANCOVA|||||1.42|-2.07|0.7084
74021564|NCT03371355|147595641|SUPERIORITY||Least Squares Mean Difference|2.79||||0.4431|TWO_SIDED|95.0|-4.41|10.0|||ANCOVA|||SBP||10.00|-4.41|0.4431
74021565|NCT03371355|147595641|SUPERIORITY||Least Squares Mean Difference|2.08||||0.563|TWO_SIDED|95.0|-5.05|9.22|||ANCOVA|||SBP||9.22|-5.05|0.5630
74021566|NCT03371355|147595641|SUPERIORITY||Least Squares Mean Difference|-1.63||||0.6634|TWO_SIDED|95.0|-9.06|5.79|||ANCOVA|||SBP||5.79|-9.06|0.6634
74021567|NCT03371355|147595641|SUPERIORITY||Least Squares Mean Difference|4.11||||0.0937|TWO_SIDED|95.0|-0.71|8.92|||ANCOVA|||DBP||8.92|-0.71|0.0937
74021568|NCT03371355|147595641|SUPERIORITY||Least Squares Mean Difference|3.49||||0.1522|TWO_SIDED|95.0|-1.31|8.28|||ANCOVA|||DBP||8.28|-1.31|0.1522
74021569|NCT03371355|147595641|SUPERIORITY||Least Squares Mean Difference|1.62||||0.5188|TWO_SIDED|95.0|-3.35|6.59|||ANCOVA|||DBP||6.59|-3.35|0.5188
74021570|NCT03371355|147595642|SUPERIORITY||Least Squares Mean Difference|0.57||||0.5299|TWO_SIDED|95.0|-1.24|2.39|||ANCOVA|||Weight||2.39|-1.24|0.5299
74021571|NCT03371355|147595642|SUPERIORITY||Least Squares Mean Difference|-0.12||||0.8919|TWO_SIDED|95.0|-1.89|1.65|||ANCOVA|||Weight||1.65|-1.89|0.8919
74021572|NCT03371355|147595642|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.6653|TWO_SIDED|95.0|-2.25|1.44|||ANCOVA|||Weight||1.44|-2.25|0.6653
74021573|NCT03371355|147595642|SUPERIORITY||Least Squares Mean Difference|2.35||||0.4213|TWO_SIDED|95.0|-3.43|8.14|||ANCOVA|||SBP||8.14|-3.43|0.4213
74021574|NCT03371355|147595642|SUPERIORITY||Least Squares Mean Difference|1.23||||0.6696|TWO_SIDED|95.0|-4.49|6.96|||ANCOVA|||SBP||6.96|-4.49|0.6696
74021575|NCT03371355|147595642|SUPERIORITY||Least Squares Mean Difference|-1.23||||0.6819|TWO_SIDED|95.0|-7.2|4.73|||ANCOVA|||SBP||4.73|-7.20|0.6819
74021576|NCT03371355|147595642|SUPERIORITY||Least Squares Mean Difference|5.01||||0.1171|TWO_SIDED|95.0|-1.28|11.31|||ANCOVA|||DBP||11.31|-1.28|0.1171
74021577|NCT03371355|147595642|SUPERIORITY||Least Squares Mean Difference|3.94||||0.2155|TWO_SIDED|95.0|-2.33|10.21|||ANCOVA|||DBP||10.21|-2.33|0.2155
74021578|NCT03371355|147595642|SUPERIORITY||Least Squares Mean Difference|1.7||||0.6034|TWO_SIDED|95.0|-4.79|8.2|||ANCOVA|||DBP||8.20|-4.79|0.6034
74021579|NCT03371355|147595643|SUPERIORITY||Least Squares Mean Difference|0.98||||0.5752|TWO_SIDED|95.0|-2.48|4.44|||ANCOVA|||||4.44|-2.48|0.5752
74021580|NCT03371355|147595643|SUPERIORITY||Least Squares Mean Difference|4.09||||0.023|TWO_SIDED|95.0|0.58|7.59|||ANCOVA|||||7.59|0.58|0.0230
74021581|NCT03371355|147595643|SUPERIORITY||Least Squares Mean Difference|1.57||||0.3965|TWO_SIDED|95.0|-2.1|5.25|||ANCOVA|||||5.25|-2.10|0.3965
74021582|NCT03371355|147595644|SUPERIORITY||Least Squares Mean Difference|12.44||||0.3023|TWO_SIDED|95.0|-11.39|36.26|||ANCOVA|||||36.26|-11.39|0.3023
74021583|NCT03371355|147595644|SUPERIORITY||Least Squares Mean Difference|26.03||||0.035|TWO_SIDED|95.0|1.87|50.19|||ANCOVA|||||50.19|1.87|0.0350
74021584|NCT03371355|147595644|SUPERIORITY||Least Squares Mean Difference|12.27||||0.3374|TWO_SIDED|95.0|-13.02|37.55|||ANCOVA|||||37.55|-13.02|0.3374
74021585|NCT03371355|147595646|SUPERIORITY||Least Squares Mean Difference|-2.59||||0.4583|TWO_SIDED|95.0|-9.49|4.31|||ANCOVA|||||4.31|-9.49|0.4583
74021586|NCT03371355|147595646|SUPERIORITY||Least Squares Mean Difference|-5.71||||0.0943|TWO_SIDED|95.0|-12.43|1.0|||ANCOVA|||||1.00|-12.43|0.0943
74021587|NCT03371355|147595646|SUPERIORITY||Least Squares Mean Difference|-4.57||||0.1909|TWO_SIDED|95.0|-11.45|2.32|||ANCOVA|||||2.32|-11.45|0.1909
74021588|NCT03371355|147595647|SUPERIORITY||Least Squares Mean Difference|7.1||||0.1294|TWO_SIDED|95.0|-2.1|16.22|||ANCOVA|||ALT||16.22|-2.10|0.1294
74021589|NCT03371355|147595647|SUPERIORITY||Least Squares Mean Difference|14.8||||0.0012|TWO_SIDED|95.0|5.98|23.59|||ANCOVA|||ALT||23.59|5.98|0.0012
74021590|NCT03371355|147595647|SUPERIORITY||Least Squares Mean Difference|8.9||||0.0594|TWO_SIDED|95.0|-0.36|18.11|||ANCOVA|||ALT||18.11|-0.36|0.0594
74021591|NCT03371355|147595647|SUPERIORITY||[Least Squares Mean Difference|5.0||||0.073|TWO_SIDED|95.0|-0.47|10.45|||ANCOVA|||AST||10.45|-0.47|0.0730
74021592|NCT03371355|147595647|SUPERIORITY||Least Squares Mean Difference|8.4||||0.002|TWO_SIDED|95.0|3.17|13.7|||ANCOVA|||AST||13.70|3.17|0.0020
74021593|NCT03371355|147595647|SUPERIORITY||Least Squares Mean Difference|6.5||||0.02|TWO_SIDED|95.0|1.05|12.0|||ANCOVA|||AST||12.00|1.05|0.0200
74021594|NCT03371355|147595648|SUPERIORITY||Least Squares Mean Difference|-1.19||||0.4812|TWO_SIDED|95.0|-4.55|2.16|||ANCOVA|||||2.16|-4.55|0.4812
74021595|NCT03371355|147595648|SUPERIORITY||Least Squares Mean Difference|-1.53||||0.3679|TWO_SIDED|95.0|-4.88|1.83|||ANCOVA|||||1.83|-4.88|0.3679
74021596|NCT03371355|147595648|SUPERIORITY||Least Squares Mean Difference|-4.18||||0.021|TWO_SIDED|95.0|-7.72|-0.65|||ANCOVA|||||-0.65|-7.72|0.0210
74021597|NCT03371355|147595649|SUPERIORITY||Least Squares Mean Difference|-0.15||||0.6227|TWO_SIDED|95.0|-0.73|0.44|||ANCOVA|||||0.44|-0.73|0.6227
74021598|NCT03371355|147595649|SUPERIORITY||Least Squares Mean Difference|-0.38||||0.195|TWO_SIDED|95.0|-0.97|0.2|||ANCOVA|||||0.20|-0.97|0.1950
74021599|NCT03371355|147595649|SUPERIORITY||Least Squares Mean Difference|-0.38||||0.2271|TWO_SIDED|95.0|-1.0|0.24|||ANCOVA|||||0.24|-1.00|0.2271
74021600|NCT03371355|147595650|SUPERIORITY||Least Squares Mean Difference|17.06||||0.8591|TWO_SIDED|95.0|-173.57|207.69|||ANCOVA|||SAT||207.69|-173.57|0.8591
74021601|NCT03371355|147595650|SUPERIORITY||Least Squares Mean Difference|32.92||||0.7404|TWO_SIDED|95.0|-164.11|229.95|||ANCOVA|||SAT||229.95|-164.11|0.7404
74021602|NCT03371355|147595650|SUPERIORITY||Least Squares Mean Difference|-16.3||||0.8711|TWO_SIDED|95.0|-215.5|182.9|||ANCOVA|||SAT||182.90|-215.50|0.8711
74021603|NCT03371355|147595650|SUPERIORITY||Least Squares Mean Difference|4.95||||0.9569|TWO_SIDED|95.0|-176.64|186.53|||ANCOVA|||VAT||186.53|-176.64|0.9569
74021604|NCT03371355|147595650|SUPERIORITY||Least Squares Mean Difference|-24.26||||0.8025|TWO_SIDED|95.0|-216.53|168.02|||ANCOVA|||VAT||168.02|-216.53|0.8025
74021605|NCT03371355|147595650|SUPERIORITY||Least Squares Mean Difference|22.02||||0.8202|TWO_SIDED|95.0|-170.09|214.12|||ANCOVA|||VAT||214.12|-170.09|0.8202
74021606|NCT03371355|147595651|SUPERIORITY||Least Squares Mean Difference|0.11||||0.9734|TWO_SIDED|95.0|-6.47|6.69|||ANCOVA|||||6.69|-6.47|0.9734
74021607|NCT03371355|147595651|SUPERIORITY||Least Squares Mean Difference|-0.7||||0.8333|TWO_SIDED|95.0|-7.25|5.86|||ANCOVA|||||5.86|-7.25|0.8333
74021608|NCT03371355|147595651|SUPERIORITY||Least Squares Mean Difference|1.66||||0.6207|TWO_SIDED|95.0|-4.99|8.31|||ANCOVA|||||8.31|-4.99|0.6207
74021609|NCT03371355|147595652|SUPERIORITY||Least Squares Mean Difference|0.01||||0.8026|TWO_SIDED|95.0|-0.04|0.06|||ANCOVA|||||0.06|-0.04|0.8026
74021610|NCT03371355|147595652|SUPERIORITY||Least Squares Mean Difference|-0.02||||0.4917|TWO_SIDED|95.0|-0.07|0.03|||ANCOVA|||||0.03|-0.07|0.4917
74021611|NCT03371355|147595652|SUPERIORITY||Least Squares Mean Difference|0.0||||0.8916|TWO_SIDED|95.0|-0.05|0.05|||ANCOVA|||||0.05|-0.05|0.8916
74021612|NCT03371355|147595653|SUPERIORITY||Least Squares Mean Difference|0.11||||0.728|TWO_SIDED|95.0|-0.5|0.71|||ANCOVA|||||0.71|-0.50|0.7280
74021613|NCT03371355|147595653|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.7354|TWO_SIDED|95.0|-0.69|0.49|||ANCOVA|||||0.49|-0.69|0.7354
74021614|NCT03371355|147595653|SUPERIORITY||Least Squares Mean Difference|-0.23||||0.4682|TWO_SIDED|95.0|-0.84|0.39|||ANCOVA|||||0.39|-0.84|0.4682
74021615|NCT00619957|147595670|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|4.53|||<|0.0001|TWO_SIDED|95.0|3.46|5.6|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||5.60|3.46|<0.0001
74021616|NCT00619957|147595671|SUPERIORITY_OR_OTHER||LS Mean Difference|2.56|||<|0.0001|TWO_SIDED|95.0|1.66|3.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.47|1.66|<0.0001
74021617|NCT00619957|147595672|SUPERIORITY_OR_OTHER||LS Mean Difference|3.18|||<|0.0001|TWO_SIDED|95.0|2.19|4.16|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||4.16|2.19|<0.0001
74021618|NCT00619957|147595673|SUPERIORITY_OR_OTHER||LS Mean Difference|4.57|||<|0.0001|TWO_SIDED|95.0|3.49|5.66|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||5.66|3.49|<0.0001
74021619|NCT00619957|147595674|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.1856|TWO_SIDED|95.0|-0.19|0.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||0.99|-0.19|0.1856
74021620|NCT00619957|147595675|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.0346|TWO_SIDED|95.0|0.05|1.25|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.25|0.05|0.0346
74021621|NCT00619957|147595676|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|0.98|2.41|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.41|0.98|<0.0001
74021622|NCT00619957|147595677|SUPERIORITY_OR_OTHER||LS Mean Difference|1.46|||<|0.0001|TWO_SIDED|95.0|0.76|2.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.17|0.76|<0.0001
74021623|NCT00619957|147595678|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.2538|TWO_SIDED|95.0|-0.36|1.36|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.36|-0.36|0.2538
74021624|NCT00619957|147595679|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.0537|TWO_SIDED|95.0|-0.01|1.74|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.74|-0.01|0.0537
74021625|NCT00619957|147595680|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24||||0.0081|TWO_SIDED|95.0|0.32|2.15|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.15|0.32|0.0081
74021626|NCT00619957|147595681|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06||||0.0187|TWO_SIDED|95.0|0.18|1.94|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.94|0.18|0.0187
74021627|NCT00619957|147595682|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.1408|TWO_SIDED|95.0|-0.19|1.34|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.34|-0.19|0.1408
74021628|NCT00619957|147595683|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.0129|TWO_SIDED|95.0|0.23|1.92|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.92|0.23|0.0129
74021629|NCT00619957|147595684|SUPERIORITY_OR_OTHER||LS Mean Difference|2.31|||<|0.0001|TWO_SIDED|95.0|1.35|3.26|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.26|1.35|<0.0001
74021630|NCT00619957|147595685|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|||<|0.0001|TWO_SIDED|95.0|1.22|3.08|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.08|1.22|<0.0001
74021631|NCT00619957|147595686|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.6|||<|0.0001|TWO_SIDED|95.0|-51.52|-35.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-35.67|-51.52|<0.0001
74021632|NCT00619957|147595687|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.72|||<|0.0001|TWO_SIDED|95.0|-58.01|-31.43|||ANOVA|Fixed effects for treatment and pooled center||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-31.43|-58.01|<0.0001
74021633|NCT00619957|147595688|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.33|||<|0.0001|TWO_SIDED|95.0|-55.99|-28.67|||ANOVA|Fixed effects for treatment and pooled centers.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-28.67|-55.99|<0.0001
74021634|NCT00619957|147595689|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.55|||<|0.0001|TWO_SIDED|95.0|-59.38|-33.72|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-33.72|-59.38|<0.0001
74081128|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.02|STANDARD_ERROR_OF_MEAN|3.31||0.7583|TWO_SIDED|90.0|-4.45|6.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.49|-4.45|0.7583
73898164|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.093||0.683|TWO_SIDED|95.0|-0.222|0.145||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.145|-0.222|0.683
74021635|NCT00619957|147595690|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.15|||<|0.0001|TWO_SIDED|95.0|-57.01|-33.29|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-33.29|-57.01|<0.0001
74021636|NCT00619957|147595691|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.88|||<|0.0001|TWO_SIDED|95.0|-23.43|-8.32|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-8.32|-23.43|<0.0001
74021637|NCT00619957|147595692|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-31.08|-12.91|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-12.91|-31.08|<0.0001
74021638|NCT00619957|147595693|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.96|||<|0.0001|TWO_SIDED|95.0|-30.75|-13.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-13.17|-30.75|<0.0001
74021639|NCT00619957|147595694|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.11||||0.0012|TWO_SIDED|95.0|-24.2|-6.02|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-6.02|-24.20|0.0012
74021640|NCT00619957|147595695|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.37||||0.0003|TWO_SIDED|95.0|-25.24|-7.49|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-7.49|-25.24|0.0003
74021641|NCT00619957|147595696|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.64|||<|0.0001|TWO_SIDED|95.0|-19.29|-11.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-11.99|-19.29|<0.0001
74021642|NCT00619957|147595697|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-25.61|-16.59|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.59|-25.61|<0.0001
74021643|NCT00619957|147595698|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.39|||<|0.0001|TWO_SIDED|95.0|-27.8|-16.98|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.98|-27.80|<0.0001
74021644|NCT00619957|147595699|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.15|||<|0.0001|TWO_SIDED|95.0|-39.84|-16.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.47|-39.84|<0.0001
74021645|NCT00619957|147595700|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.25|||<|0.0001|TWO_SIDED|95.0|-37.63|-16.87|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.87|-37.63|<0.0001
74021646|NCT00619957|147595701|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.8794|TWO_SIDED|95.0|-1.99|1.71|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.71|-1.99|0.8794
74021647|NCT00619957|147595702|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47||||0.6658|TWO_SIDED|95.0|-2.62|1.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.67|-2.62|0.6658
74021648|NCT00619957|147595703|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.784|TWO_SIDED|95.0|-2.39|1.81|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.81|-2.39|0.7840
74021649|NCT00619957|147595704|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Controlled for pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||||<0.0001
74021650|NCT00619957|147595705|SUPERIORITY_OR_OTHER||Relative Risk|0.771||||0.7284||95.0|0.184|3.226|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.226|0.184|0.7284
74021651|NCT00619957|147595706|SUPERIORITY_OR_OTHER||Relative Risk|0.688||||0.5293|TWO_SIDED|95.0|0.245|1.932|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.932|0.245|0.5293
74021652|NCT01957137|147595756|SUPERIORITY_OR_OTHER|||||||0.3773|||||||Mixed Models Analysis|The final model included cycling, period and the interaction between cycling and period.||||||0.3773
74021653|NCT01957137|147595757|SUPERIORITY_OR_OTHER|||||||0.2396|||||||Mixed Models Analysis|The final model included cycling and period.||||||0.2396
74021654|NCT01957137|147595758|SUPERIORITY_OR_OTHER|||||||0.8874|||||||Mixed Models Analysis|The final model included cycling and period.||||||0.8874
74021655|NCT01795547|147595815|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the primary endpoint was considered confirmed if the lower bound of the 2-sided 95% CI at Week 28 was \> -5 or equivalently if the p-value for the 1-sided test of H0: D ≤ -5 against H1: D \> -5 was ≤2.5%, where D was the mean treatment difference (aripiprazole minus paliperidone). Superiority was then tested as pre-specified with the FAS and demonstrated for aripiprazole over paliperidone, since the lower bound of the 95% CI was \>0.|Least Squares Mean Difference|4.666||||0.036|TWO_SIDED|95.0|0.316|9.015|||Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||Comparison of aripiprazole versus paliperidone was made using estimates from a mixed model for repeated measurements (MMRM) using an unstructured covariance matrix.||9.015|0.316|0.036
74021656|NCT01795547|147595816|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.492||||0.043|TWO_SIDED|95.0|-2.935|-0.049||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||-0.049|-2.935|0.043
74081129|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.11|STANDARD_ERROR_OF_MEAN|3.33||0.3516|TWO_SIDED|90.0|-2.39|8.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.61|-2.39|0.3516
74081130|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.83|STANDARD_ERROR_OF_MEAN|3.38||0.5877|TWO_SIDED|90.0|-7.42|3.75||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.75|-7.42|0.5877
74081131|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.33|STANDARD_ERROR_OF_MEAN|3.38||0.2016|TWO_SIDED|90.0|-9.92|1.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.26|-9.92|0.2016
74081132|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-6.49|STANDARD_ERROR_OF_MEAN|3.39||0.0568|TWO_SIDED|90.0|-12.08|-0.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-0.89|-12.08|0.0568
74081133|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.94|STANDARD_ERROR_OF_MEAN|3.36||0.3827|TWO_SIDED|90.0|-8.48|2.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||2.61|-8.48|0.3827
74081134|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-5.31|STANDARD_ERROR_OF_MEAN|3.33||0.1126|TWO_SIDED|90.0|-10.81|0.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||0.20|-10.81|0.1126
73836831|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.23|6.25||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||6.25|0.23|
74021657|NCT01795547|147595817|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.283||||0.004|TWO_SIDED|95.0|-0.477|-0.09||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||-0.090|-0.477|0.004
74021658|NCT01795547|147595818|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.331||||0.149|TWO_SIDED|95.0|-0.12|0.782||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||0.782|-0.120|0.149
74021659|NCT01795547|147595819|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.753||||0.039|TWO_SIDED|95.0|0.093|3.412||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||3.412|0.093|0.039
74021660|NCT01795547|147595820|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.764||||0.07|TWO_SIDED|95.0|-0.143|3.672||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||3.672|-0.143|0.070
74021661|NCT01795547|147595821|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.922||||0.13|TWO_SIDED|95.0|-0.275|2.119||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||2.119|-0.275|0.130
74021662|NCT01795547|147595822|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.007||||0.561|TWO_SIDED|95.0|-2.402|4.417||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||4.417|-2.402|0.561
74021663|NCT01795547|147595823|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.695||||0.095|TWO_SIDED|95.0|-1.511|0.121||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||0.121|-1.511|0.095
74021664|NCT02764541|147595837|EQUIVALENCE|The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive ductal carcinoma||||||0.0045|||||||Wilcoxon (Mann-Whitney)|||||||0.0045
74021665|NCT02764541|147595837|EQUIVALENCE|The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive lobular carcinoma||||||0.0161|||||||Wilcoxon (Mann-Whitney)|||||||0.0161
74021666|NCT02764541|147595838|EQUIVALENCE|The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D||||||0.9288|||||||Wilcoxon (Mann-Whitney)|||||||0.9288
74021667|NCT02764541|147595840|EQUIVALENCE|The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D|Mean Difference (Final Values)|0.02||||0.92|TWO_SIDED|95.0|-0.29|0.32|||Regression, Linear|||||0.32|-0.29|0.920
74021668|NCT02764541|147595841|EQUIVALENCE|The hypothesis is that there is no difference of RCB response rate between Arm C and Arm D||||||0.758|||||||Fisher Exact|||||||0.758
74021669|NCT01552343|147595847|SUPERIORITY_OR_OTHER|||||||0.0187||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Correlation - no adjustments||||0.0187
74021670|NCT01552343|147595847|SUPERIORITY_OR_OTHER|||||||0.0094||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline # of voids||||0.0094
74021671|NCT01552343|147595847|SUPERIORITY_OR_OTHER|||||||0.0383||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline NI total score||||0.0383
74021672|NCT01552343|147595847|SUPERIORITY_OR_OTHER|||||||0.0133||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - age category||||0.0133
74021673|NCT01552343|147595847|SUPERIORITY_OR_OTHER|||||||0.0128||95.0|||||t-test, 2 sided|The a priori threshold for statistical significance was 0.05.||Partial correlation - gender||||0.0128
74021674|NCT01552343|147595848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.7|||||TWO_SIDED|95.0|2.7|18.8|||||Non-Responders - Responders|Nocturia Impact (NI) Total Score (Q1-Q11)||18.8|2.7|
74021675|NCT01552343|147595848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-9.6|9.6|||||Non-Responders - Responders|Overall Impact Question (Q12)||9.6|-9.6|
74021676|NCT01552343|147595851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6||||0.1471|TWO_SIDED|95.0|-20.3|3.1||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Screening||3.1|-20.3|0.1471
74021677|NCT01552343|147595851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6||||0.0318|TWO_SIDED|95.0|-26.0|-1.2||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Baseline||-1.2|-26.0|0.0318
74021678|NCT01552343|147595851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.8||||0.0463|TWO_SIDED|95.0|-31.2|-0.3||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Screening||-0.3|-31.2|0.0463
74021679|NCT01552343|147595851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7||||0.0413|TWO_SIDED|95.0|-34.6|-0.7||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Baseline||-0.7|-34.6|0.0413
74081135|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.17|STANDARD_ERROR_OF_MEAN|3.36||0.216|TWO_SIDED|90.0|-9.73|1.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.38|-9.73|0.2160
74081136|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.54|STANDARD_ERROR_OF_MEAN|3.74||0.3443|TWO_SIDED|90.0|-2.64|9.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.72|-2.64|0.3443
74081137|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.82|STANDARD_ERROR_OF_MEAN|3.7||0.3031|TWO_SIDED|90.0|-2.3|9.94||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.94|-2.30|0.3031
74081138|NCT02554877|147714170|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.88|STANDARD_ERROR_OF_MEAN|3.72||0.8129|TWO_SIDED|90.0|-5.27|7.04||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||7.04|-5.27|0.8129
74081139|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.34|STANDARD_ERROR_OF_MEAN|0.4||0.402|TWO_SIDED|90.0|-0.33|1.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||1.01|-0.33|0.4020
74081140|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.06|STANDARD_ERROR_OF_MEAN|0.4||0.8789|TWO_SIDED|90.0|-0.61|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||0.73|-0.61|0.8789
74081141|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.87|STANDARD_ERROR_OF_MEAN|0.41||0.0345|TWO_SIDED|90.0|0.19|1.54||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||1.54|0.19|0.0345
74081142|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.28|STANDARD_ERROR_OF_MEAN|0.48||0.0087|TWO_SIDED|90.0|0.48|2.08||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.08|0.48|0.0087
74081143|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.08|STANDARD_ERROR_OF_MEAN|0.48||0.0268|TWO_SIDED|90.0|0.28|1.88||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.88|0.28|0.0268
74081144|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.39|STANDARD_ERROR_OF_MEAN|0.49||0.0047|TWO_SIDED|90.0|0.58|2.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.19|0.58|0.0047
74081145|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.07|STANDARD_ERROR_OF_MEAN|0.42||0.0116|TWO_SIDED|90.0|0.38|1.76||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.76|0.38|0.0116
74081146|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.97|STANDARD_ERROR_OF_MEAN|0.42||0.022|TWO_SIDED|90.0|0.27|1.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.66|0.27|0.0220
74081147|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.31|STANDARD_ERROR_OF_MEAN|0.42||0.0021|TWO_SIDED|90.0|0.62|2.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||2.01|0.62|0.0021
74081148|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.41|STANDARD_ERROR_OF_MEAN|0.51||0.0067|TWO_SIDED|90.0|0.56|2.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.26|0.56|0.0067
74081149|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.18|STANDARD_ERROR_OF_MEAN|0.51||0.0225|TWO_SIDED|90.0|0.33|2.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.02|0.33|0.0225
74081150|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.4|STANDARD_ERROR_OF_MEAN|0.51||0.0073|TWO_SIDED|90.0|0.55|2.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.25|0.55|0.0073
74081151|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2391|TWO_SIDED|90.0|-0.12|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.73|-0.12|0.2391
74081152|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9912|TWO_SIDED|90.0|-0.42|0.43||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.43|-0.42|0.9912
74081153|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.34|STANDARD_ERROR_OF_MEAN|0.26||0.193|TWO_SIDED|90.0|-0.09|0.77||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.77|-0.09|0.1930
74081154|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.8|STANDARD_ERROR_OF_MEAN|0.27||0.0038|TWO_SIDED|90.0|0.35|1.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||1.25|0.35|0.0038
74081155|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.57|STANDARD_ERROR_OF_MEAN|0.27||0.0394|TWO_SIDED|90.0|0.12|1.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.02|0.12|0.0394
74081156|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.48|STANDARD_ERROR_OF_MEAN|0.28||0.0862|TWO_SIDED|90.0|0.02|0.93||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||0.93|0.02|0.0862
74081157|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.05|STANDARD_ERROR_OF_MEAN|0.34||0.0024|TWO_SIDED|90.0|0.48|1.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.61|0.48|0.0024
74081158|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.92|STANDARD_ERROR_OF_MEAN|0.34||0.0068|TWO_SIDED|90.0|0.37|1.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.48|0.37|0.0068
74081159|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.86|STANDARD_ERROR_OF_MEAN|0.34||0.0132|TWO_SIDED|90.0|0.29|1.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.42|0.29|0.0132
74081160|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.39|STANDARD_ERROR_OF_MEAN|0.45||0.0024|TWO_SIDED|90.0|0.65|2.14||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||2.14|0.65|0.0024
74081161|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.15|STANDARD_ERROR_OF_MEAN|0.45||0.0115|TWO_SIDED|90.0|0.4|1.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.89|0.40|0.0115
74081162|NCT02554877|147714171|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.97|STANDARD_ERROR_OF_MEAN|0.45||0.0344|TWO_SIDED|90.0|0.22|1.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.72|0.22|0.0344
74081163|NCT01410227|147714192|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis of the rate of subjects with a treatment success of \<= 0.65 (H0: p \<= 0.65) versus an alternative hypothesis of \> 0.65 (HA: p \> 0.65) was tested at the 5% one-sided level of significance. The proportion of subjects with treatment success under the alternative hypothesis was expected to be approximately 0.90. If 20 subjects were treated, the study provided 86% power to reject the null hypothesis.|Clopper-Pearson|100.0|||||TWO_SIDED|90.0|84.7|100.0|||Clopper-Pearson|||||100|84.7|
74081164|NCT01484912|147714259|NON_INFERIORITY_OR_EQUIVALENCE|The superiority testing was conducted one sided with 0.025 significance level. If H0 was rejected one-sided 0.025 significance level, STA-2 was concluded to be statistically superior to Placebo.All hypothesis testing except for the primary efficacy endpoint was conducted two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.||||||0.025||95.0|||||t-test, 1 sided|||T-test was used to compare the change in total exercise time between the treatment groups. The change in total exercise time (△) was defined as the total exercise time at end-point visit minus the total exercise time at baseline. Let △T be the change in total exercise time for treatment group (STA-2) and △C be the change in total exercise time for control group (Placebo). The hypothesis testing for the superiority of STA-2 to Placebo was H0：△T-△C≦0 with H1：△T-△C﹥0.||||0.025
74081165|NCT01484912|147714260|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||All hypothesis testing was conducted with T-tests, two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.||||0.005
74081166|NCT00985439|147714299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.407|STANDARD_ERROR_OF_MEAN|2.643|<|0.001|TWO_SIDED|95.0|6.195|16.619|||ANCOVA|||||16.619|6.195|<0.001
74081167|NCT05143801|147714300|EQUIVALENCE|Main effect for environmental conditions.||||||0.003||||||Statistical significance was set at p \< 0.05.|2x2 repeated measures ANOVA|||||||0.003
74081168|NCT05143801|147714300|EQUIVALENCE|Main effect for mask condition.||||||0.933||||||Statistical significance was set at p \< 0.05.|2x2 repeated measures ANOVA|||||||0.933
74081169|NCT05143801|147714300|EQUIVALENCE|Interaction effect across environmental and mask conditions.|No Method of Estimation was used|||||0.344||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 repeated measures ANOVA|||||||0.344
74081170|NCT05143801|147714301|EQUIVALENCE|Main effect for environmental conditions.||||||0.117||||||Statistical significance was set at p \< 0.05.|2x2 Repeated Measures ANOVA|||A 2x2 repeated measures ANOVA was performed to investigate statistical differences for all variables across the four conditions. Both main and interaction effects were calculated along with effect size, reported as partial ⴄ2 as provided by the statistical software JASP (version 0.14.1.0).||||0.117
74081171|NCT05143801|147714301|EQUIVALENCE|Main effect for mask condition||||||0.832||||||Statistical significance was set at p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.832
74081172|NCT05143801|147714301|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.879||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.879
74081173|NCT05143801|147714302|EQUIVALENCE|Main effect for environmental condition.||||||0.749||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.749
74081174|NCT05143801|147714302|EQUIVALENCE|Main effect for mask condition.||||||0.311||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.311
74081175|NCT05143801|147714302|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.368||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.368
74081176|NCT05143801|147714303|EQUIVALENCE|Main effect for environmental condition.||||||0.789||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.789
74021680|NCT01552343|147595852|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.9647|TWO_SIDED|95.0|-6.6|6.3|||ANCOVA|Covariates baseline score, treatment and age stratum (\<65, \>=65).||Treatment effect. NI total scores are transformed to a 0-100 scale where 0 is good and 100 bad.||6.3|-6.6|0.9647
74021681|NCT01813890|147595894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|105.61||||0.006|TWO_SIDED|95.0|32.0|179.2||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.||179.2|32.0|0.006
74081177|NCT05143801|147714303|EQUIVALENCE|Main effect for mask condition.||||||0.739||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.739
74081178|NCT05143801|147714303|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.158||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.158
74081179|NCT05143801|147714304|EQUIVALENCE|Main effect for environmental condition.||||||0.394||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.394
74081180|NCT05143801|147714304|EQUIVALENCE|Main effect for mask condition||||||0.157||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.157
74081181|NCT05143801|147714304|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.015||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.015
74081182|NCT05143801|147714305|EQUIVALENCE|Main effect for environmental condition.||||||0.96||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.960
74081183|NCT05143801|147714305|EQUIVALENCE|Main effect for mask condition.||||||0.073||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.073
74081184|NCT05143801|147714305|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.503||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.503
74081185|NCT05143801|147714306|EQUIVALENCE|Main effect for environmental condition.||||||0.786||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.786
74081186|NCT05143801|147714306|EQUIVALENCE|Main effect for mask condition.||||||0.18||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.180
73836832|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.17|3.92||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.92|0.17|
74021682|NCT01813890|147595894|SUPERIORITY_OR_OTHER||Median Difference (Net)|126.58||||0.004|TWO_SIDED|95.0|49.5|203.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.||203.7|49.5|0.004
74021683|NCT03952559|147595905|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7261|TWO_SIDED|95.0|0.58|2.21|||Regression, Logistic|||||2.21|0.58|0.7261
74021684|NCT03952559|147595905|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0718|TWO_SIDED|95.0|0.95|3.41|||Regression, Logistic|||||3.41|0.95|0.0718
74021685|NCT03952559|147595905|SUPERIORITY||Odds Ratio (OR)|3.73|||<|0.0001|TWO_SIDED|95.0|2.02|6.89|||Regression, Logistic|||||6.89|2.02|<0.0001
74021686|NCT03952559|147595908|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9615|TWO_SIDED|95.0|0.59|1.74|||Regression, Logistic|||||1.74|0.59|0.9615
74021687|NCT03952559|147595908|SUPERIORITY||Odds Ratio (OR)|1.42||||0.201|TWO_SIDED|95.0|0.83|2.41|||Regression, Logistic|||||2.41|0.83|0.2010
74021688|NCT03952559|147595908|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0017|TWO_SIDED|95.0|1.38|3.95|||Regression, Logistic|||||3.95|1.38|0.0017
74021689|NCT03952559|147595909|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8544|TWO_SIDED|95.0|0.43|2.01|||Regression, Logistic|||||2.01|0.43|0.8544
74021690|NCT03952559|147595909|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0561|TWO_SIDED|95.0|0.98|3.91|||Regression, Logistic|||||3.91|0.98|0.0561
74021691|NCT03952559|147595909|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0012|TWO_SIDED|95.0|1.54|5.82|||Regression, Logistic|||||5.82|1.54|0.0012
74021692|NCT03952559|147595910|SUPERIORITY||LS Mean difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.349||0.2627|TWO_SIDED|95.0|-4.16|1.14|||Mixed Models Analysis|||||1.14|-4.16|0.2627
74021693|NCT03952559|147595910|SUPERIORITY||LS Mean difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|1.342||0.2135|TWO_SIDED|95.0|-4.31|0.97|||Mixed Models Analysis|||||0.97|-4.31|0.2135
74021694|NCT03952559|147595910|SUPERIORITY||LS Mean difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|1.347||0.0443|TWO_SIDED|95.0|-5.36|-0.07|||Mixed Models Analysis|||||-0.07|-5.36|0.0443
74021695|NCT03952559|147595911|SUPERIORITY||Odds Ratio (OR)|0.73||||0.4943|TWO_SIDED|95.0|0.3|1.78|||Regression, Logistic|||||1.78|0.30|0.4943
74021696|NCT03952559|147595911|SUPERIORITY||Odds Ratio (OR)|1.72||||0.1677|TWO_SIDED|95.0|0.8|3.7|||Regression, Logistic|||||3.70|0.80|0.1677
74021697|NCT03952559|147595911|SUPERIORITY||Odds Ratio (OR)|2.24||||0.0336|TWO_SIDED|95.0|1.06|4.7|||Regression, Logistic|||||4.70|1.06|0.0336
74021698|NCT03952559|147595912|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8866|TWO_SIDED|95.0|0.42|2.77|||Regression, Logistic|||||2.77|0.42|0.8866
74021699|NCT03952559|147595912|SUPERIORITY||Odds Ratio (OR)|1.73||||0.2316|TWO_SIDED|95.0|0.7|4.26|||Regression, Logistic|||||4.26|0.70|0.2316
74021700|NCT03952559|147595912|SUPERIORITY||Odds Ratio, log|2.59||||0.0328|TWO_SIDED|95.0|1.08|6.22|||Regression, Logistic|||||6.22|1.08|0.0328
74021701|NCT03952559|147595913|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5361|TWO_SIDED|95.0|0.7|1.98|||Regression, Logistic|||||1.98|0.70|0.5361
74021702|NCT03952559|147595913|SUPERIORITY||Odds Ratio (OR)|1.23||||0.4417|TWO_SIDED|95.0|0.73|2.06|||Regression, Logistic|||||2.06|0.73|0.4417
74021703|NCT03952559|147595913|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0121|TWO_SIDED|95.0|1.16|3.43|||Regression, Logistic|||||3.43|1.16|0.0121
74021704|NCT03952559|147595914|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7706|TWO_SIDED|95.0|0.37|3.78|||Regression, Logistic|||||3.78|0.37|0.7706
74021705|NCT03952559|147595914|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7409|TWO_SIDED|95.0|0.38|3.86|||Regression, Logistic|||||3.86|0.38|0.7409
74021706|NCT03952559|147595914|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0253|TWO_SIDED|95.0|1.15|8.63|||Regression, Logistic|||||8.63|1.15|0.0253
74021707|NCT03952559|147595915|SUPERIORITY||LS Mean difference (Final Values)|-3.89|STANDARD_ERROR_OF_MEAN|2.576||0.1317|TWO_SIDED|95.0|-8.95|1.17|||Mixed Models Analysis|||||1.17|-8.95|0.1317
74021708|NCT03952559|147595915|SUPERIORITY||LS Mean difference (Final Values)|-5.15|STANDARD_ERROR_OF_MEAN|2.564||0.0451|TWO_SIDED|95.0|-10.19|-0.11|||Mixed Models Analysis|||||-0.11|-10.19|0.0451
74021709|NCT03952559|147595915|SUPERIORITY||LS Mean difference (Final Values)|-7.62|STANDARD_ERROR_OF_MEAN|2.566||0.0031|TWO_SIDED|95.0|-12.66|-2.58|||Mixed Models Analysis|||||-2.58|-12.66|0.0031
74021710|NCT03952559|147595916|SUPERIORITY||Odds Ratio (OR)|0.53||||0.4238|TWO_SIDED|95.0|0.11|2.49|||Regression, Logistic|||||2.49|0.11|0.4238
74021711|NCT03952559|147595916|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5118|TWO_SIDED|95.0|0.44|5.08|||Regression, Logistic|||||5.08|0.44|0.5118
74021712|NCT03952559|147595916|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0129|TWO_SIDED|95.0|1.34|11.52|||Regression, Logistic|||||11.52|1.34|0.0129
74021713|NCT03952559|147595917|SUPERIORITY||LS Mean difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|2.168||0.4852|TWO_SIDED|95.0|-5.77|2.75|||Mixed Models Analysis|||||2.75|-5.77|0.4852
74021714|NCT03952559|147595917|SUPERIORITY||LS Mean difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|2.16||0.4205|TWO_SIDED|95.0|-5.98|2.5|||Mixed Models Analysis|||||2.50|-5.98|0.4205
74021715|NCT03952559|147595917|SUPERIORITY||LS Mean difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.161||0.0138|TWO_SIDED|95.0|-9.59|-1.1|||Mixed Models Analysis|||||-1.10|-9.59|0.0138
74021716|NCT03952559|147595918|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
74021717|NCT03952559|147595918|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.540
74021718|NCT03952559|147595918|SUPERIORITY|||||||0.302|||||||Fisher Exact|||||||0.302
74081187|NCT05143801|147714306|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.239||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.239
74081188|NCT05143801|147714307|EQUIVALENCE|Main effect for environmental condition.||||||0.134||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.134
74081189|NCT05143801|147714307|EQUIVALENCE|Main effect for mask condition.||||||0.621||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.621
74081190|NCT05143801|147714307|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.553||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.553
74081191|NCT05143801|147714308|EQUIVALENCE|Main effect for environmental condition.||||||0.461||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.461
74081192|NCT05143801|147714308|EQUIVALENCE|Main effect for mask condition.||||||0.877||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.877
74081193|NCT05143801|147714308|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.919||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.919
74081194|NCT05143801|147714309|EQUIVALENCE|Main effect for environmental condition.||||||0.466||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.466
74081195|NCT05143801|147714309|EQUIVALENCE|Main effect for mask condition.||||||0.186||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.186
74081196|NCT05143801|147714309|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.08||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.080
74081197|NCT05143801|147714310|EQUIVALENCE|Main effect for environmental condition.||||||0.375||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.375
74081198|NCT05143801|147714310|EQUIVALENCE|Main effect for mask condition.||||||0.178||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.178
74021719|NCT03952559|147595919|SUPERIORITY||LS Mean difference (Final Values)|4.47|STANDARD_ERROR_OF_MEAN|5.03||0.375|TWO_SIDED|95.0|-5.41|14.35|||ANOVA|||||14.35|-5.41|0.375
74081199|NCT05143801|147714310|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.533||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.533
74081200|NCT05143801|147714311|EQUIVALENCE|Main effect for environmental condition.||||||0.29||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.290
74081201|NCT05143801|147714311|EQUIVALENCE|Main effect for mask condition.||||||0.527||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.527
74081202|NCT05143801|147714311|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.045||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.045
74081203|NCT05143801|147714312|EQUIVALENCE|Main effect for environmental condition.||||||0.018||||||Statistical significance was set at p \< 0.05|2x2x3 Repeated Measures ANOVA|||||||0.018
74081204|NCT05143801|147714312|EQUIVALENCE|Main effect for mask condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2x3 Repeated Measures ANOVA|||||||<0.001
74081205|NCT05143801|147714312|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.035||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2x3 Repeated Measures ANOVA|||||||0.035
74081206|NCT05143801|147714313|EQUIVALENCE|Main effect for environmental condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||<0.001
74081207|NCT05143801|147714313|EQUIVALENCE|Main effect for mask condition.||||||0.678||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.678
74081208|NCT05143801|147714313|EQUIVALENCE|Interaction effect||||||0.678|||||||2x2 Repeated Measures ANOVA|||||||0.678
74081209|NCT05143801|147714314|EQUIVALENCE|Main effect for environmental condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||<0.001
74081210|NCT05143801|147714314|EQUIVALENCE|Main effect for mask condition.||||||0.487||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.487
74081211|NCT05143801|147714314|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.79||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.790
74081212|NCT05143801|147714315|EQUIVALENCE|Main effect for environmental condition.||||||0.089||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.089
74081213|NCT05143801|147714315|EQUIVALENCE|Main effect for mask condition.||||||0.297||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.297
74081214|NCT05143801|147714315|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.111||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.111
74081215|NCT05143801|147714316|EQUIVALENCE|Main effect for environmental condition.||||||0.024||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.024
74081216|NCT05143801|147714316|EQUIVALENCE|Main effect for mask condition.||||||0.002||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.002
74081217|NCT05143801|147714316|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.014||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.014
74081218|NCT05143801|147714317|EQUIVALENCE|Main effect for environmental condition.||||||0.012||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.012
74081219|NCT05143801|147714317|EQUIVALENCE|Main effect for mask condition.||||||0.893||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.893
74081220|NCT05143801|147714317|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.969||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.969
74081221|NCT04428307|147714328|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.61|2.02||||||||2.02|0.61|
74081222|NCT04428307|147714328|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.49|1.71||||||||1.71|0.49|
74081223|NCT04428307|147714329|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.83|1.8||||||||1.80|0.83|
74081224|NCT04428307|147714329|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.81|1.62||||||||1.62|0.81|
74081225|NCT04428307|147714330|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.8|1.09||||||||1.09|0.80|
74081226|NCT04428307|147714330|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||||1.16|0.85|
74081227|NCT04428307|147714331|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.75|1.73||||||||1.73|0.75|
74021720|NCT03952559|147595919|SUPERIORITY||LS Mean difference (Final Values)|3.12|STANDARD_ERROR_OF_MEAN|5.03||0.536|TWO_SIDED|95.0|-6.76|13.0|||ANOVA|||||13.00|-6.76|0.536
74081228|NCT04428307|147714331|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.77|1.74||||||||1.74|0.77|
74081229|NCT04428307|147714332|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.95|1.11||||||||1.11|0.95|
74081230|NCT04428307|147714332|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.89|1.04||||||||1.04|0.89|
74081231|NCT02054715|147714360|OTHER||Mean Difference (MP - PE)|-0.1|STANDARD_ERROR_OF_MEAN|2.0||0.9621|TWO_SIDED|95.0|-4.1|3.9|||F-Test|||Two-sided F-Test as a statistical comparing MP and PE means.||3.9|-4.1|0.9621
74081232|NCT02054715|147714361|OTHER||Mean Difference (MP - PE)|0.18|STANDARD_ERROR_OF_MEAN|1.57||0.9065|TWO_SIDED|95.0|-2.89|3.26|||F-test|||Two-sided F-Test comparing the MP and PE means.||3.26|-2.89|0.9065
74081233|NCT02054715|147714362|OTHER||Mean Difference (MP - PE)|-0.05|STANDARD_ERROR_OF_MEAN|1.4||0.9709|TWO_SIDED|95.0|-2.79|2.69|||F-Test|||Two-sided F-Test comparing the MP and PE means.||2.69|-2.79|0.9709
74081234|NCT02054715|147714363|OTHER|||||||0.014|||||||Chi-squared|||Chi-square test between MP and PE. 69% of subjects that got the Multimedia Psychoeducation intervention chose to participate in a clinical trial, compared with 62% in the Print Education group||||0.014
74081235|NCT00073307|147714368|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.146||95.0|0.74|1.04||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.||1.04|0.74|0.146
74081236|NCT00073307|147714369|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0287||95.0|0.62|0.97||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.||0.97|0.62|0.0287
74081237|NCT00073307|147714370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||<|1e-06||95.0|0.35|0.55|||Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|The planned final PFS analysis was to be performed when approximately 363 progressions or deaths (if death occurred before progression) were observed. The analysis had power of 90% to detect a 50% increase in PFS using a two-sided alpha of 0.01||0.55|0.35|<0.000001
74081238|NCT00073307|147714371|SUPERIORITY_OR_OTHER||Difference in response rates (CR+PR)|-2.1||||||95.0|-3.7|-0.6|||Cochran-Mantel-Haenszel|Adjustments for country and Motzer category|difference in response rates (CR+PR) = Placebo - Sorafenib|||-0.6|-3.7|
74081239|NCT00073307|147714372|SUPERIORITY_OR_OTHER|||||||0.98|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline FKSI-10 score and relative day of FKSI-10 completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05||||0.98
74081240|NCT00073307|147714373|SUPERIORITY_OR_OTHER|||||||0.83|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline PWB score and relative day of PWB completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05||||0.83
74081241|NCT01438060|147714374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.802|TWO_SIDED|95.0|-1.15|1.49||Baseline data was evaluated by analysis of variance (ANOVA) with treatment and study center as main effects.|ANOVA||Model based estimate.|Analysis at Baseline (Day 0)||1.49|-1.15|0.802
74081242|NCT01438060|147714374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.169|TWO_SIDED|95.0|-2.49|0.44||ANCOVA model for LOCF data set included the baseline measure as covariate and the study center and treatment as main effects.|ANCOVA||Model based estimate|Analysis at Week 10||0.44|-2.49|0.169
74081243|NCT01438060|147714377|SUPERIORITY_OR_OTHER||Response ratio|0.79||||0.391|TWO_SIDED|95.0|0.47|1.35|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test with controlling for treatment and study center||Analysis at Week 1||1.35|0.47|0.391
74081244|NCT01438060|147714377|SUPERIORITY_OR_OTHER||Response ratio|0.95||||0.766|TWO_SIDED|95.0|0.69|1.31|||Cochran-Mantel-Haenszel|CMH test with controlling for treatment and study center||Analysis at Week 2||1.31|0.69|0.766
74021721|NCT03952559|147595919|SUPERIORITY||LS Mean difference (Final Values)|12.17|STANDARD_ERROR_OF_MEAN|5.03||0.016|TWO_SIDED|95.0|2.29|22.05|||ANOVA|||||22.05|2.29|0.016
74021722|NCT03952559|147595920|SUPERIORITY||LS Mean difference (Final Values)|-49.19|STANDARD_ERROR_OF_MEAN|27.28||0.073|TWO_SIDED|95.0|-102.81|4.42|||ANOVA|||||4.42|-102.81|0.073
74021723|NCT03952559|147595920|SUPERIORITY||LS Mean difference (Final Values)|-37.38|STANDARD_ERROR_OF_MEAN|27.29||0.172|TWO_SIDED|95.0|-91.0|16.23|||ANOVA|||||16.23|-91.00|0.172
74021724|NCT03952559|147595920|SUPERIORITY||LS Mean difference (Final Values)|-80.37|STANDARD_ERROR_OF_MEAN|27.28||0.004|TWO_SIDED|95.0|-133.98|-26.75|||ANOVA|||||-26.75|-133.98|0.004
74021725|NCT03952559|147595921|SUPERIORITY||LS Mean difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.372||0.0829|TWO_SIDED|95.0|-1.38|0.08|||Mixed Models Analysis|||||0.08|-1.38|0.0829
74021726|NCT03952559|147595921|SUPERIORITY||LS Mean difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.368||0.1752|TWO_SIDED|95.0|-1.22|0.22|||Mixed Models Analysis|||||0.22|-1.22|0.1752
74021727|NCT03952559|147595921|SUPERIORITY||LS Mean difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.366||0.0029|TWO_SIDED|95.0|-1.82|-0.38|||Mixed Models Analysis|||||-0.38|-1.82|0.0029
74021728|NCT03952559|147595922|SUPERIORITY||LS Mean difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.193||0.2688|TWO_SIDED|95.0|-0.6|0.17|||Mixed Models Analysis|||||0.17|-0.60|0.2688
74021729|NCT03952559|147595922|SUPERIORITY||LS Mean difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.193||0.0166|TWO_SIDED|95.0|-0.85|-0.09|||Mixed Models Analysis|||||-0.09|-0.85|0.0166
74021730|NCT03952559|147595922|SUPERIORITY||LS Mean difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.202||0.0908|TWO_SIDED|95.0|-0.75|0.06|||Mixed Models Analysis|||||0.06|-0.75|0.0908
74021731|NCT03952559|147595923|SUPERIORITY||LS Mean difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.956||0.3409|TWO_SIDED|95.0|-2.79|0.97|||Mixed Models Analysis|||||0.97|-2.79|0.3409
74021732|NCT03952559|147595923|SUPERIORITY||LS Mean difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.952||0.1022|TWO_SIDED|95.0|-3.43|0.31|||Mixed Models Analysis|||||0.31|-3.43|0.1022
74021733|NCT03952559|147595923|SUPERIORITY||LS Mean difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.953||0.1024|TWO_SIDED|95.0|-3.43|0.31|||Mixed Models Analysis|||||0.31|-3.43|0.1024
74021734|NCT03952559|147595924|SUPERIORITY||LS Mean difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.157||0.1436|TWO_SIDED|95.0|-0.54|0.08|||Mixed Models Analysis|||||0.08|-0.54|0.1436
74021735|NCT03952559|147595924|SUPERIORITY||LS Mean difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.154||0.0483|TWO_SIDED|95.0|-0.61|0.0|||Mixed Models Analysis|||||-0.00|-0.61|0.0483
74021736|NCT03952559|147595924|SUPERIORITY||LS Mean difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.154||0.0012|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||||-0.20|-0.80|0.0012
74021737|NCT03952559|147595925|SUPERIORITY||LS Mean difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.755||0.9183|TWO_SIDED|95.0|-3.27|3.63|||Mixed Models Analysis|||for 8 to \<18 years old||3.63|-3.27|0.9183
74021738|NCT03952559|147595925|SUPERIORITY||LS Mean difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|1.529||0.4805|TWO_SIDED|95.0|-4.09|1.93|||Mixed Models Analysis|||for 8 to \<18 years old||1.93|-4.09|0.4805
74021739|NCT03952559|147595925|SUPERIORITY||LS Mean difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.812||0.3488|TWO_SIDED|95.0|-5.26|1.86|||Mixed Models Analysis|||for 8 to \<18 years old||1.86|-5.26|0.3488
74021740|NCT03952559|147595925|SUPERIORITY||LS Mean difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|3.12||0.2388|TWO_SIDED|95.0|-4.85|7.66|||Mixed Models Analysis|||for 5 to \<8 years old||7.66|-4.85|0.2388
74021741|NCT03952559|147595925|SUPERIORITY||LS Mean difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|3.542||0.0098|TWO_SIDED|95.0|-10.23|3.98|||Mixed Models Analysis|||for 5 to \<8 years old||3.98|-10.23|0.0098
74021742|NCT03952559|147595925|SUPERIORITY||LS Mean difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|3.14||0.1698|TWO_SIDED|95.0|-5.18|7.42|||Mixed Models Analysis|||for 5 to \<8 years old||7.42|-5.18|0.1698
74021743|NCT03952559|147595926|SUPERIORITY||LS Mean difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|1.813||0.8611|TWO_SIDED|95.0|-3.24|3.88|||Mixed Models Analysis|||for 8 to \<18 years old||3.88|-3.24|0.8611
74021744|NCT03952559|147595926|SUPERIORITY||LS Mean difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|1.571||0.5098|TWO_SIDED|95.0|-4.12|2.05|||Mixed Models Analysis|||for 8 to \<18 years old||2.05|-4.12|0.5098
74021745|NCT03952559|147595926|SUPERIORITY||LS Mean difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.87||0.1997|TWO_SIDED|95.0|-6.08|1.27|||Mixed Models Analysis|||for 8 to \<18 years old||1.27|-6.08|0.1997
74021746|NCT03952559|147595926|SUPERIORITY||LS Mean difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|3.351||0.1957|TWO_SIDED|95.0|-5.11|8.35|||Mixed Models Analysis|||for 5 to \<8 years old||8.35|-5.11|0.1957
74081245|NCT01438060|147714377|SUPERIORITY_OR_OTHER||Response ratio|1.01||||0.967|TWO_SIDED|95.0|0.76|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 3||1.32|0.76|0.967
74081246|NCT01438060|147714377|SUPERIORITY_OR_OTHER||Response ratio|0.92||||0.505|TWO_SIDED|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 4||1.19|0.71|0.505
74081247|NCT01438060|147714377|SUPERIORITY_OR_OTHER||Response ratio|1.07||||0.59|TWO_SIDED|95.0|0.84|1.36||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 6||1.36|0.84|0.590
74021747|NCT03952559|147595926|SUPERIORITY||LS Mean difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|3.864||0.0881|TWO_SIDED|95.0|-8.19|7.32|||Mixed Models Analysis|||for 5 to \<8 years old||7.32|-8.19|0.0881
74021748|NCT03952559|147595926|SUPERIORITY||LS Mean difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|3.379||0.1604|TWO_SIDED|95.0|-5.27|8.28|||Mixed Models Analysis|||for 5 to \<8 years old||8.28|-5.27|0.1604
74021749|NCT03952559|147595927|SUPERIORITY||LS Mean difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.647||0.2987|TWO_SIDED|95.0|-1.93|0.59|||Mixed Models Analysis|||||0.59|-1.93|0.2987
74021750|NCT03952559|147595927|SUPERIORITY||LS Mean difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.632||0.3096|TWO_SIDED|95.0|-1.88|0.6|||Mixed Models Analysis|||||0.60|-1.88|0.3096
74081248|NCT01438060|147714377|SUPERIORITY_OR_OTHER||Response ratio|1.1||||0.374|TWO_SIDED|95.0|0.89|1.37||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 8||1.37|0.89|0.374
74081249|NCT01438060|147714377|SUPERIORITY_OR_OTHER||Response ratio|1.15||||0.175|TWO_SIDED|95.0|0.94|1.41||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 10||1.41|0.94|0.175
74081250|NCT01438060|147714378|SUPERIORITY_OR_OTHER||Response ratio|0.88||||0.753|TWO_SIDED|95.0|0.41|1.92||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 1||1.92|0.41|0.753
74081251|NCT01438060|147714378|SUPERIORITY_OR_OTHER||Response ratio|0.9||||0.6|TWO_SIDED|95.0|0.62|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 2||1.32|0.62|0.600
74021751|NCT03952559|147595927|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.635||0.6341|TWO_SIDED|95.0|-1.55|0.95|||Mixed Models Analysis|||||0.95|-1.55|0.6341
74081252|NCT01438060|147714378|SUPERIORITY_OR_OTHER||Response ratio|0.93||||0.673|TWO_SIDED|95.0|0.65|1.31||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 3||1.31|0.65|0.673
74081253|NCT01438060|147714378|SUPERIORITY_OR_OTHER||Response ratio|0.83||||0.255|TWO_SIDED|95.0|0.6|1.14||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 4||1.14|0.60|0.255
74021752|NCT03952559|147595928|SUPERIORITY||LS Mean difference (Final Values)|5.27|STANDARD_ERROR_OF_MEAN|4.323||0.2871|TWO_SIDED|95.0|-6.54|17.09|||Mixed Models Analysis|||||17.09|-6.54|0.2871
74021753|NCT03952559|147595928|SUPERIORITY||LS Mean difference (Final Values)|4.73|STANDARD_ERROR_OF_MEAN|3.835||0.3093|TWO_SIDED|95.0|-7.83|17.29|||Mixed Models Analysis|||||17.29|-7.83|0.3093
74021754|NCT03952559|147595928|SUPERIORITY||LS Mean difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|3.788||0.2912|TWO_SIDED|95.0|-18.22|8.21|||Mixed Models Analysis|||||8.21|-18.22|0.2912
74021755|NCT03952559|147595929|SUPERIORITY|Absenteeism Change from Baseline|LS Mean difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|3.119||0.6079|TWO_SIDED|95.0|-7.74|4.54|||Mixed Models Analysis|||||4.54|-7.74|0.6079
74021756|NCT03952559|147595929|SUPERIORITY||LS Mean difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|3.092||0.5492|TWO_SIDED|95.0|-7.94|4.24|||Mixed Models Analysis|||Absenteeism Change from Baseline||4.24|-7.94|0.5492
74021757|NCT03952559|147595929|SUPERIORITY||LS Mean difference (Final Values)|-4.93|STANDARD_ERROR_OF_MEAN|3.281||0.1338|TWO_SIDED|95.0|-11.39|1.53|||Mixed Models Analysis|||Absenteeism Change from Baseline||1.53|-11.39|0.1338
74021758|NCT03952559|147595929|SUPERIORITY||LS Mean difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|3.566||0.7928|TWO_SIDED|95.0|-7.96|6.08|||Mixed Models Analysis|||Presenteeism Change from Baseline||6.08|-7.96|0.7928
74021759|NCT03952559|147595929|SUPERIORITY||LS Mean difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|3.553||0.1366|TWO_SIDED|95.0|-12.3|1.69|||Mixed Models Analysis|||Presenteeism Change from Baseline||1.69|-12.30|0.1366
74021760|NCT03952559|147595929|SUPERIORITY||LS Mean difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|3.792||0.076|TWO_SIDED|95.0|-14.21|0.71|||Mixed Models Analysis|||Presenteeism Change from Baseline||0.71|-14.21|0.0760
74021761|NCT03952559|147595929|SUPERIORITY||LS Mean difference (Final Values)|-4.18|STANDARD_ERROR_OF_MEAN|4.561||0.3602|TWO_SIDED|95.0|-13.16|4.8|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||4.80|-13.16|0.3602
74021762|NCT03952559|147595929|SUPERIORITY||LS Mean difference (Final Values)|-6.25|STANDARD_ERROR_OF_MEAN|4.516||0.1678|TWO_SIDED|95.0|-15.14|2.65|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||2.65|-15.14|0.1678
74021763|NCT03952559|147595929|SUPERIORITY||LS Mean difference (Final Values)|-11.54|STANDARD_ERROR_OF_MEAN|4.808||0.017|TWO_SIDED|95.0|-21.0|-2.08|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-2.08|-21.00|0.0170
74021764|NCT03952559|147595929|SUPERIORITY||LS Mean difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|3.174||0.1645|TWO_SIDED|95.0|-10.66|1.82|||Mixed Models Analysis|||Activity Impairment Change from Baseline||1.82|-10.66|0.1645
74081254|NCT01438060|147714378|SUPERIORITY_OR_OTHER||Response ratio|0.99||||0.958|TWO_SIDED|95.0|0.74|1.33||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 6||1.33|0.74|0.958
74081255|NCT01438060|147714378|SUPERIORITY_OR_OTHER||Response ratio|0.92||||0.525|TWO_SIDED|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 8||1.19|0.71|0.525
74081256|NCT01438060|147714378|SUPERIORITY_OR_OTHER||Response ratio|1.07||||0.602|TWO_SIDED|95.0|0.82|1.4||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 10||1.40|0.82|0.602
74081257|NCT01438060|147714382|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 1||||0.133
74081258|NCT01438060|147714382|SUPERIORITY_OR_OTHER|||||||0.282||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 2||||0.282
74081259|NCT01438060|147714382|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 3||||0.571
74081260|NCT01438060|147714382|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 4||||0.895
74081261|NCT01438060|147714382|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 6||||0.817
74081262|NCT01438060|147714382|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 8||||0.795
74081263|NCT01438060|147714382|SUPERIORITY_OR_OTHER|||||||0.564||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 10||||0.564
74081264|NCT01438060|147714384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.733|TWO_SIDED|95.0|-1.08|1.54|||ANCOVA|||Analysis at baseline||1.54|-1.08|0.733
74081265|NCT01438060|147714384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.001|TWO_SIDED|95.0|-2.16|-0.54|||ANOVA|||Analysis at Week 10||-0.54|-2.16|0.001
74088208|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.18||0.0005|TWO_SIDED|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.27|-0.98|0.0005
74081266|NCT01442376|147714416|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|0.36|||||TWO_SIDED|97.5|-11.7|12.4||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.||12.4|-11.7|
74081267|NCT01442376|147714416|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|-4.4|||||TWO_SIDED|97.5|-16.4|7.6||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.||7.6|-16.4|
74081268|NCT03499873|147714418|EQUIVALENCE|90% CI on the Test-to-Reference difference for the proportion of subjects with cure should be contained within the interval \[-0.20, +0.20\]|Mean Difference (Net)|-0.026|||||TWO_SIDED|90.0|-0.124|0.073||||||||0.073|-0.124|
74081269|NCT03499873|147714418|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
74081270|NCT03499873|147714418|SUPERIORITY|||||||0.0003|||||||ANOVA|||||||0.0003
74081271|NCT00840281|147714419|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|94.9|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||105|94.9|
74081272|NCT00840281|147714420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.6|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||103|98.6|
74081273|NCT00840281|147714421|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|98.7|
74081274|NCT00957021|147714473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||KSS Pain/Motion and Function Score comparison from pre-op to 1, 2 and 5 year||||<.0001
74081275|NCT00957021|147714474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Physical score comparison from pre-op to 1, 2, 3, 4 and 5 years||||<.0001
74081276|NCT00957021|147714474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 1 year||||<.0001
74081277|NCT00957021|147714474|SUPERIORITY_OR_OTHER|||||||0.0017|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 2 year||||0.0017
74081278|NCT00957021|147714474|SUPERIORITY_OR_OTHER|||||||0.0055|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 3 year||||0.0055
74081279|NCT00957021|147714474|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 4 year||||0.0050
74081280|NCT00957021|147714474|SUPERIORITY_OR_OTHER|||||||0.0018|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 5 year||||0.0018
74081281|NCT00957021|147714476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||LEAS score comparison from pre-op to 1, 2, 3, 4 and 5 years||||<.0001
74081282|NCT03031795|147714478|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance was set at \< 0.05 for each row comparison with no adjustment for multiple comparisons.|Wilcoxon rank sum test|||"A 2 point difference was used to power the study. This is consistent with previous definitions of a clinically meaningful reductions in pain and provides a visually meaningful change on the 0-10 numerical rating scale with anchors at every other point, for example moving from very severe (8) to severe pain (6) or from moderate pain (4) to mild pain (2)."||||< 0.05
74081283|NCT01986647|147714485|SUPERIORITY_OR_OTHER|||||||0.2691|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.2691
74081284|NCT01986647|147714486|SUPERIORITY_OR_OTHER|||||||0.6087|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.6087
74081285|NCT01986647|147714487|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.0022
74081286|NCT01986647|147714488|SUPERIORITY_OR_OTHER|||||||0.0344|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.0344
74081287|NCT01986647|147714489|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.6879|TWO_SIDED|95.0|0.49|1.6|||Regression, Logistic|||||1.60|0.49|0.6879
74081288|NCT01986647|147714490|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.88||||0.5719|TWO_SIDED|95.0|0.56|1.37|||Regression, Logistic|||||1.37|0.56|0.5719
74081289|NCT01986647|147714491|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.489|TWO_SIDED|95.0|0.44|5.53|||Regression, Logistic|||||5.53|0.44|0.489
74081290|NCT01986647|147714492|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12||||0.2981|TWO_SIDED|95.0|0.37|26.6|||Regression, Logistic|||||26.6|0.37|0.2981
74081291|NCT01986647|147714493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9279|TWO_SIDED|95.0|0.3|3.74|||Regression, Logistic|||||3.74|0.30|0.9279
74081292|NCT01986647|147714494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.5835|TWO_SIDED|95.0|0.67|2.06|||Regression, Logistic|||||2.06|0.67|0.5835
74081293|NCT01986647|147714495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.46||0.18|TWO_SIDED||||||Mixed Models Analysis|||||||0.18
74081294|NCT01986647|147714496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|1.42||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
74081295|NCT01986647|147714497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
74021765|NCT03952559|147595929|SUPERIORITY||LS Mean difference (Final Values)|-4.87|STANDARD_ERROR_OF_MEAN|3.158||0.124|TWO_SIDED|95.0|-11.07|1.34|||Mixed Models Analysis|||Activity Impairment Change from Baseline||1.34|-11.07|0.1240
74021766|NCT03952559|147595929|SUPERIORITY||LS Mean difference (Final Values)|-7.02|STANDARD_ERROR_OF_MEAN|3.163||0.027|TWO_SIDED|95.0|-13.23|-0.8|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-0.80|-13.23|0.0270
74021767|NCT03952559|147595930|SUPERIORITY||LS Mean difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|2.778||0.4778|TWO_SIDED|95.0|-3.49|7.43|||Mixed Models Analysis|||||7.43|-3.49|0.4778
74021768|NCT03952559|147595930|SUPERIORITY||LS Mean difference (Final Values)|2.01|STANDARD_ERROR_OF_MEAN|2.743||0.4649|TWO_SIDED|95.0|-3.38|7.39|||Mixed Models Analysis|||||7.39|-3.38|0.4649
74021769|NCT03952559|147595930|SUPERIORITY||LS Mean difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|2.755||0.1013|TWO_SIDED|95.0|-0.89|9.94|||Mixed Models Analysis|||||9.94|-0.89|0.1013
74021770|NCT03952559|147595931|SUPERIORITY||LS Mean difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.174||0.6574|TWO_SIDED|95.0|-0.27|0.42|||Mixed Models Analysis|||||0.42|-0.27|0.6574
74021771|NCT03952559|147595931|SUPERIORITY||LS Mean difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.172||0.9488|TWO_SIDED|95.0|-0.35|0.33|||Mixed Models Analysis|||||0.33|-0.35|0.9488
74021772|NCT03952559|147595931|SUPERIORITY||LS Mean difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.172||0.4546|TWO_SIDED|95.0|-0.47|0.21|||Mixed Models Analysis|||||0.21|-0.47|0.4546
74021773|NCT03952559|147595932|SUPERIORITY||LS Mean difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.36||0.8133|TWO_SIDED|95.0|-0.79|0.62|||Mixed Models Analysis|||||0.62|-0.79|0.8133
74021774|NCT03952559|147595932|SUPERIORITY||LS Mean difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.355||0.2517|TWO_SIDED|95.0|-1.11|0.29|||Mixed Models Analysis|||||0.29|-1.11|0.2517
74021775|NCT03952559|147595932|SUPERIORITY||LS Mean difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.354||0.0803|TWO_SIDED|95.0|-1.32|0.08|||Mixed Models Analysis|||||0.08|-1.32|0.0803
74021776|NCT01870739|147595940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0616||||0.7324|TWO_SIDED|95.0|-0.4178|0.2947|||Linear Model|Treatment as fixed effect and corresponding baseline as covariate.||||0.2947|-0.4178|0.7324
74021777|NCT01870739|147595941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0371||||0.8614|TWO_SIDED|95.0|-0.4582|0.3839|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate||||0.3839|-0.4582|0.8614
74021778|NCT01870739|147595942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0812||||0.7946|TWO_SIDED|95.0|-0.6987|0.5362|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate||||0.5362|-0.6987|0.7946
74021779|NCT01986062|147595950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
74081296|NCT01986647|147714498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.004||0.77|TWO_SIDED||||||Mixed Models Analysis|||||||0.77
74021780|NCT01986062|147595951|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
74021781|NCT01986062|147595952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
74021782|NCT01986062|147595953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
74021783|NCT01986062|147595954|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
74021784|NCT01986062|147595955|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
74021785|NCT00630331|147595973|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|83.8|||<|0.001|ONE_SIDED|97.5|61.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||61.0|<0.001
74021786|NCT00630331|147595973|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|88.2|||<|0.001|ONE_SIDED|97.5|67.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||67.4|<0.001
74021787|NCT00630331|147595973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||97.5||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the CCI vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.||||0.999
74021788|NCT00630331|147595973|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.394|ONE_SIDED|97.5|-410.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-410|0.394
74081297|NCT01986647|147714499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.44||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
74081298|NCT01986647|147714500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.0324|TWO_SIDED|95.0|0.29|0.95|||Regression, Logistic|||||0.95|0.29|0.0324
74081299|NCT05604209|147714520|SUPERIORITY||Median log2 fold change|1.63|||<|0.001|TWO_SIDED|95.0|0.67|2.14|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within all vaccinees is zero.||2.14|0.67|<0.001
74081300|NCT05604209|147714520|SUPERIORITY||median log2 fold change|1.15||||0.008|TWO_SIDED|95.0|0.09|2.59|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within the C62-M4 vaccinated arm is zero.||2.59|0.09|0.008
74021789|NCT00630331|147595973|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|78.4||||0.004|ONE_SIDED|97.5|52.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||52.1|0.004
74021790|NCT00630331|147595973|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|80.3||||0.002|ONE_SIDED|97.5|54.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||54.7|0.002
74021791|NCT00630331|147595973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992||97.5||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the IVV vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.||||0.992
74021792|NCT00630331|147595973|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.4|ONE_SIDED|97.5|-429.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-429.4|0.400
74021793|NCT00630331|147595974|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|58.7||||0.078|ONE_SIDED|97.5|33.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||33.5|0.078
74021794|NCT00630331|147595974|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|87.3||||0.104|ONE_SIDED|97.5|4.6|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||4.6|0.104
74021795|NCT00630331|147595974|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.03|ONE_SIDED|97.5|36.3|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||36.3|0.030
74021796|NCT00630331|147595974|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|50.0||||0.376|ONE_SIDED|97.5|17.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||17.5|0.376
74021797|NCT00630331|147595974|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|58.6||||0.085|ONE_SIDED|97.5|32.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||32.9|0.085
74021798|NCT00630331|147595974|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.033|ONE_SIDED|97.5|33.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||33.9|0.033
74081301|NCT05604209|147714520|SUPERIORITY||Median log2 fold change|1.66||||0.008|TWO_SIDED|95.0|0.93|4.59|||Wilcoxon (Mann-Whitney)|Within-am log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within the C1C62-M3M4 vaccinated arm is zero.||4.59|0.93|0.008
74081302|NCT05604209|147714520|SUPERIORITY|||||||0.279|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-1 from baseline to day 35 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-1 from pre-vaccination to day 35 are the same between the two vaccinated arms.||||0.279
74081303|NCT05604209|147714521|SUPERIORITY||Median log2 fold change|1.66|||<|0.001|TWO_SIDED|95.0|1.09|2.33|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within all vaccinees is zero.||2.33|1.09|<0.001
74081304|NCT05604209|147714521|SUPERIORITY||Median log2 fold change|1.79||||0.008|TWO_SIDED|95.0|0.59|3.4|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within the C62-M4 vaccinated arm is zero.||3.40|0.59|0.008
74081305|NCT05604209|147714521|SUPERIORITY||Median log2 fold change|1.66||||0.008|TWO_SIDED|95.0|0.94|3.09|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within the C1C62-M3M4 vaccinated arm is zero.||3.09|0.94|0.008
74081306|NCT05604209|147714521|SUPERIORITY|||||||0.878|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-2 from baseline to day 35 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-2 from pre-vaccination to day 35 are the same between the two vaccinated arms.||||0.878
74081307|NCT05604209|147714522|SUPERIORITY||Median log2 fold change|1.47|||<|0.001|TWO_SIDED|95.0|0.54|2.63|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within all vaccinees is zero.||2.63|0.54|<0.001
74081308|NCT05604209|147714522|SUPERIORITY||Median log2 fold change|1.09||||0.008|TWO_SIDED|95.0|0.39|3.61|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within the C62-M4 vaccinated arm is zero.||3.61|0.39|0.008
74081309|NCT05604209|147714522|SUPERIORITY||Median log2 fold change|2.0||||0.016|TWO_SIDED|95.0|0.43|4.37|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within the C1C62-M3M4 vaccinated arm is zero.||4.37|0.43|0.016
74081310|NCT05604209|147714522|SUPERIORITY|||||||0.189|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-1 from baseline to day 42 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-1 from pre-vaccination to day 42 are the same between the two vaccinated arms.||||0.189
74081311|NCT05604209|147714523|SUPERIORITY||Median log2 fold change|1.78|||<|0.001|TWO_SIDED|95.0|0.81|2.51|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within all vaccinees is zero.||2.51|0.81|<0.001
74081312|NCT05604209|147714523|SUPERIORITY||Median log2 fold change|1.57||||0.008|TWO_SIDED|95.0|0.63|3.89|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within the C62-M4 vaccinated arm is zero.||3.89|0.63|0.008
74081313|NCT05604209|147714523|SUPERIORITY||Median log2 fold change|1.78||||0.016|TWO_SIDED|95.0|0.7|3.79|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within the C162-M3M4 vaccinated arm is zero.||3.79|0.70|0.016
74081314|NCT05604209|147714523|SUPERIORITY|||||||0.955|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-2 from baseline to day 42 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-2 from pre-vaccination to day 42 are the same between the two vaccinated arms.||||0.955
74081315|NCT05604209|147714524|SUPERIORITY||Median Difference (Net)|2.0||||0.125|TWO_SIDED|95.0|-1.0|4.0|||Wilcoxon (Mann-Whitney)|Within-group changes in breadth from baseline to day 56 were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median change in breadth of T-cell response to HIV-1 subpools from baseline to day 56 within all vaccinees is zero.||4|-1|0.125
74081316|NCT00112437|147714525|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.5|||<=|0.001|TWO_SIDED|95.0|2.54|4.45||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||4.45|2.54|<=0.001
74081317|NCT00112437|147714525|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.78|||<=|0.001|TWO_SIDED|95.0|1.82|3.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||3.73|1.82|<=0.001
74081318|NCT00112437|147714525|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.63||||0.003|TWO_SIDED|95.0|0.68|2.59||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||2.59|0.68|0.003
74021799|NCT00630331|147595974|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|73.6||||0.265|ONE_SIDED|97.5|-30.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-30.0|0.265
74021800|NCT00630331|147595974|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|51.7||||0.319|ONE_SIDED|97.5|19.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||19.4|0.319
74021801|NCT00630331|147595975|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|69.5|||<|0.001|ONE_SIDED|97.5|55.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||55.0|<0.001
74021802|NCT00630331|147595975|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|89.3|||<|0.001|ONE_SIDED|97.5|73.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||73.0|<0.001
74021803|NCT00630331|147595975|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|75.6||||0.04|ONE_SIDED|97.5|35.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||35.1|0.040
74021804|NCT00630331|147595975|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|49.9||||0.37|ONE_SIDED|97.5|18.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||18.2|0.37
74021805|NCT00630331|147595975|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|63.0||||0.003|ONE_SIDED|97.5|46.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||46.7|0.003
74021806|NCT00630331|147595975|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|81.5|||<|0.001|ONE_SIDED|97.5|60.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||60.9|<0.001
74021807|NCT00630331|147595975|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|49.3||||0.53|ONE_SIDED|97.5|-9.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-9.0|0.53
74081319|NCT00112437|147714525|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.49||||0.343|TWO_SIDED|95.0|-1.44|0.46||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||0.46|-1.44|0.343
74081320|NCT00112437|147714526|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.67|||<=|0.001|TWO_SIDED|95.0|4.32|7.02||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||7.02|4.32|<=0.001
73898165|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898166|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.094||0.848|TWO_SIDED|95.0|-0.168|0.204||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.204|-0.168|0.848
73898167|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|0.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898168|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.656|TWO_SIDED|95.0|-0.305|0.192||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.192|-0.305|0.656
73898169|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898170|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.124||0.777|TWO_SIDED|95.0|-0.279|0.209||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.209|-0.279|0.777
74021808|NCT00630331|147595975|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|53.2||||0.26|ONE_SIDED|97.5|22.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||22.2|0.26
73898171|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898172|NCT02880956|147328878|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.128||0.256|TWO_SIDED|95.0|-0.106|0.397||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.397|-0.106|0.256
74021809|NCT00288574|147596000|SUPERIORITY|||||||0.57|||||||Chi-squared|||The proportion of patients successfully completing the trial in the fluoxetine and placebo groups was compared using the chi-squared statistic.||||0.57
74021810|NCT00288574|147596001|SUPERIORITY|||||||0.75||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in body weight, in fluoxetine vs placebo groups.||||0.75
74021811|NCT00288574|147596002|SUPERIORITY|||||||0.007||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment of BDI in fluoxetine versus placebo groups||||0.007
74021812|NCT00288574|147596003|SUPERIORITY|||||||0.79||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in BDI, in fluoxetine vs placebo groups.||||0.79
74021813|NCT00288574|147596004|SUPERIORITY|||||||0.69||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in RSES, in fluoxetine vs placebo groups.||||0.69
74021814|NCT00288574|147596005|SUPERIORITY|||||||0.78||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Q-LES-Q, in fluoxetine vs placebo groups.||||0.78
74021815|NCT00288574|147596006|SUPERIORITY|||||||0.19||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Drive for Thinness subscale, in fluoxetine vs placebo groups.||||0.19
74081321|NCT00112437|147714526|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.45|||<=|0.001|TWO_SIDED|95.0|3.15|5.76||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||5.76|3.15|<=0.001
74081322|NCT00112437|147714526|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.39|||<=|0.001|TWO_SIDED|95.0|2.06|4.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||4.73|2.06|<=0.001
74081323|NCT00112437|147714526|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.84||||0.218||95.0|-2.19|0.51||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||0.51|-2.19|0.218
74081324|NCT00112437|147714527|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.49|||<=|0.001|TWO_SIDED|95.0|1.62|3.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||3.35|1.62|<=0.001
74081325|NCT00112437|147714527|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.06|||<=|0.001|TWO_SIDED|95.0|1.2|2.93||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||2.93|1.20|<=0.001
74081326|NCT00112437|147714527|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.67|||<=|0.001|TWO_SIDED|95.0|0.8|2.53||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||2.53|0.80|<=0.001
74081327|NCT00112437|147714527|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.75||||0.135|TWO_SIDED|95.0|-1.61|0.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||0.11|-1.61|0.135
74081328|NCT00112437|147714528|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.66|||<=|0.001|TWO_SIDED|95.0|1.71|3.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||3.61|1.71|<=0.001
74081329|NCT00112437|147714528|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.89|||<=|0.001|TWO_SIDED|95.0|0.93|2.84||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||2.84|0.93|<=0.001
74081330|NCT00112437|147714528|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.87||||0.095|TWO_SIDED|95.0|-0.09|1.82||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||1.82|-0.09|0.095
74081331|NCT00112437|147714528|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.19|||||TWO_SIDED|95.0|-1.14|0.75|||ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||0.75|-1.14|
74081332|NCT00112437|147714529|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.94|||<=|0.001|TWO_SIDED|95.0|1.64|4.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||4.24|1.64|<=0.001
74081333|NCT00112437|147714529|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.65|||<=|0.001|TWO_SIDED|95.0|1.35|3.94||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||3.94|1.35|<=0.001
74081334|NCT00112437|147714529|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.38|||<=|0.001|TWO_SIDED|95.0|1.08|3.69||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||3.69|1.08|<=0.001
74081335|NCT00112437|147714529|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.29||||0.731|TWO_SIDED|95.0|-1.58|1.0||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||1.00|-1.58|0.731
74081336|NCT00112437|147714530|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.29||||0.112|TWO_SIDED|95.0|-0.77|1.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||1.35|-0.77|0.112
74081337|NCT00112437|147714530|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.09|||||TWO_SIDED|95.0|-1.13|0.95||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||0.95|-1.13|
74081338|NCT00112437|147714530|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.63|||||TWO_SIDED|95.0|-1.69|0.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||0.42|-1.69|
74021816|NCT00288574|147596007|SUPERIORITY|||||||0.46||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Bulimia subscale, in fluoxetine vs placebo groups.||||0.46
74081339|NCT00112437|147714530|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.47|||||TWO_SIDED|95.0|-2.53|-0.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||-0.42|-2.53|
74081340|NCT00112437|147714531|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.23|||<=|0.001|TWO_SIDED|95.0|0.22|2.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||2.24|0.22|<=0.001
74081341|NCT00112437|147714531|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.1||||0.005|TWO_SIDED|95.0|0.09|2.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||2.11|0.09|0.005
74088209|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.33|-1.06|0.0002
73898173|NCT02880956|147328878|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898174|NCT02880956|147328879|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.479|TWO_SIDED|95.0|-0.269|0.126||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.126|-0.269|0.479
73898175|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898176|NCT02880956|147328879|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.099||0.295|TWO_SIDED|95.0|-0.299|0.091||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.091|-0.299|0.295
73898177|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73959049|NCT02393716|147453913|OTHER|Single arm study with a hypothesis test comparing to performance goal|Percentage|2.9|||<|0.001|ONE_SIDED|97.5||7.2|||Based on exact binomial distribution|||"The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a MAE within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 20% is the safety PG."||7.2||<0.001
74021817|NCT00288574|147596008|SUPERIORITY|||||||0.86||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Body Dissatisfaction subscale, in fluoxetine vs placebo groups.||||0.86
74021818|NCT00288574|147596009|SUPERIORITY|||||||0.25||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Perfectionism subscale, in fluoxetine vs placebo groups.||||0.25
73898178|NCT02880956|147328879|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.102||0.884|TWO_SIDED|95.0|-0.186|0.215||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.215|-0.186|0.884
73898179|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898180|NCT02880956|147328879|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.569|TWO_SIDED|95.0|-0.281|0.155||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.155|-0.281|0.569
74021819|NCT00288574|147596010|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.||Random effects regression analysis of change during treatment on the YBC-EDS, in fluoxetine vs placebo groups.||||0.26
73898181|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898182|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_ERROR_OF_MEAN|0.108||0.702|TWO_SIDED|95.0|-0.254|0.171||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.171|-0.254|0.702
73898183|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898184|NCT02880956|147328879|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.111||0.566|TWO_SIDED|95.0|-0.155|0.283||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.283|-0.155|0.566
73898185|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898186|NCT02880956|147328879|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.133||0.141|TWO_SIDED|95.0|-0.458|0.065||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.065|-0.458|0.141
73898187|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
74081342|NCT00112437|147714531|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.27||||0.63|TWO_SIDED|95.0|-0.74|1.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||1.29|-0.74|0.630
73898188|NCT02880956|147328879|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.131||0.834|TWO_SIDED|95.0|-0.285|0.23||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.230|-0.285|0.834
73898189|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|0.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898190|NCT02880956|147328879|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.133||0.724|TWO_SIDED|95.0|-0.309|0.215||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.215|-0.309|0.724
73898191|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898192|NCT02880956|147328879|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.166||0.163|TWO_SIDED|95.0|-0.559|0.095||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.095|-0.559|0.163
73898193|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|0.24|STANDARD_DEVIATION|0.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
74021820|NCT01955707|147596011|SUPERIORITY_OR_OTHER||adjusted mean difference (log-scale)|0.08|||||TWO_SIDED|90.0|-0.09|0.26||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tissue plasminogen activator (tPA) use.||0.26|-0.09|
73898194|NCT02880956|147328879|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.163||0.497|TWO_SIDED|95.0|-0.432|0.21||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.210|-0.432|0.497
73898195|NCT02880956|147328879|SUPERIORITY||effect size|0.1|STANDARD_DEVIATION|1.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898196|NCT02880956|147328879|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.168||0.919|TWO_SIDED|95.0|-0.314|0.349||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.349|-0.314|0.919
73898197|NCT02880956|147328879|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
74081343|NCT00112437|147714531|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.27|||||TWO_SIDED|95.0|-2.28|-0.27||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||-0.27|-2.28|
74081344|NCT00112437|147714532|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-57.86|||<=|0.001|TWO_SIDED|95.0|-72.33|-43.38||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-43.38|-72.33|<=0.001
74081345|NCT00112437|147714532|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-45.92|||<=|0.001|TWO_SIDED|95.0|-60.93|-30.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-30.91|-60.93|<=0.001
74081346|NCT00112437|147714532|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-31.84|||<=|0.001|TWO_SIDED|95.0|-48.11|-15.58||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-15.58|-48.11|<=0.001
74081347|NCT00112437|147714532|SUPERIORITY_OR_OTHER||Difference in Least Square Means|11.17||||0.249|TWO_SIDED|95.0|-0.94|43.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||43.24|-0.94|0.249
74081348|NCT00112437|147714533|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-56.33|||<=|0.001||95.0|-75.86|-36.81||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||-36.81|-75.86|<=0.001
74081349|NCT00112437|147714533|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-35.57|||<=|0.001||95.0|-56.63|-14.51||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Square Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||-14.51|-56.63|<=0.001
74081350|NCT00112437|147714533|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-21.66||||0.08||95.0|-44.54|1.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||1.23|-44.54|0.080
74081351|NCT00112437|147714533|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.7|||||TWO_SIDED|95.0|-8.48|47.88||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||47.88|-8.48|
74081352|NCT00112437|147714534|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-18.28||||0.004|TWO_SIDED|95.0|-35.82|-0.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||-0.74|-35.82|0.004
74081353|NCT00112437|147714534|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.26||||0.344|TWO_SIDED|95.0|-19.9|17.39||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||17.39|-19.90|0.344
74081354|NCT00112437|147714534|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.33|||||TWO_SIDED|95.0|-20.55|17.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||17.89|-20.55|
74081355|NCT00112437|147714534|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|28.15|||||TWO_SIDED|95.0|5.84|50.46||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||50.46|5.84|
74081356|NCT00112437|147714535|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-15.57|||<=|0.001|TWO_SIDED|95.0|-26.11|-5.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||-5.04|-26.11|<=0.001
74081357|NCT00112437|147714535|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.43||||0.645|TWO_SIDED|95.0|-6.02|16.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||16.89|-6.02|0.645
74088210|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.05|-0.32|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.32|-1.05|0.0002
73836833|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.11|4.43||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||4.43|0.11|
73898198|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.352||0.423|TWO_SIDED|95.0|-0.974|0.409||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.409|-0.974|0.423
73898199|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898200|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.346||0.036|TWO_SIDED|95.0|-1.408|-0.047||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.047|-1.408|0.036
73898201|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|2.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898202|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.355||0.121|TWO_SIDED|95.0|-1.25|0.147||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.147|-1.250|0.121
73898203|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898204|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.371||0.244|TWO_SIDED|95.0|-1.163|0.296||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.296|-1.163|0.244
73898205|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|2.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898206|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.36||0.085|TWO_SIDED|95.0|-1.33|0.086||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.086|-1.330|0.085
73898207|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|0.21|STANDARD_DEVIATION|3.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898208|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.371||0.137|TWO_SIDED|95.0|-1.28|0.177||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.177|-1.280|0.137
73898209|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|0.19|STANDARD_DEVIATION|2.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
74088211|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.2||0.0506|TWO_SIDED|95.0|-0.78|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.00|-0.78|0.0506
73898210|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.352||0.258|TWO_SIDED|95.0|-0.294|1.091||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.091|-0.294|0.258
73898211|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|2.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898212|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.348||0.711|TWO_SIDED|95.0|-0.555|0.814||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.814|-0.555|0.711
73898213|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|3.05|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898214|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.35||0.503|TWO_SIDED|95.0|-0.454|0.924||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.924|-0.454|0.503
73898215|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898216|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.404||0.978|TWO_SIDED|95.0|-0.806|0.784||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.784|-0.806|0.978
73898217|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|3.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898218|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.402||0.265|TWO_SIDED|95.0|-1.239|0.342||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.342|-1.239|0.265
73898219|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|3.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898220|NCT02880956|147328880|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.414||0.789|TWO_SIDED|95.0|-0.704|0.925||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.925|-0.704|0.789
73898221|NCT02880956|147328880|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|2.82|||TWO_SIDED|||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.||||
73898222|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.6||0.72|TWO_SIDED|95.0|-0.965|1.395||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.395|-0.965|0.720
74021821|NCT01955707|147596011|SUPERIORITY_OR_OTHER||ratio of relative growth|1.09||||0.779|TWO_SIDED|90.0|0.91|1.3||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.30|0.91|0.779
74021822|NCT01955707|147596012|SUPERIORITY_OR_OTHER||adjusted mean difference (log-scale)|0.09|||||TWO_SIDED|90.0|-0.09|0.27||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.27|-0.09|
74021823|NCT01955707|147596012|SUPERIORITY_OR_OTHER||ratio of relative growth|1.09||||0.797|TWO_SIDED|90.0|0.92|1.31||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.31|0.92|0.797
74081358|NCT00112437|147714535|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|11.73|||||TWO_SIDED|95.0|-0.47|23.92||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||23.92|-0.47|
74081359|NCT00112437|147714535|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|44.85|||||TWO_SIDED|95.0|30.55|59.16||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||59.16|30.55|
74081360|NCT00112437|147714536|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-35.74|||<=|0.001|TWO_SIDED|95.0|-52.14|-19.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||-19.33|-52.14|<=0.001
74021824|NCT01955707|147596013|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|0.05|||||TWO_SIDED|90.0|-0.13|0.24||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.24|-0.13|
74021825|NCT01955707|147596013|SUPERIORITY_OR_OTHER||ratio of relative growth|1.05||||0.684|TWO_SIDED|90.0|0.88|1.27||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.27|0.88|0.684
74021826|NCT01955707|147596014|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|0.0|||||TWO_SIDED|90.0|-0.12|0.11||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.11|-0.12|
73898223|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|4.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898224|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.592||0.455|TWO_SIDED|95.0|-1.607|0.722||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.722|-1.607|0.455
74021827|NCT01955707|147596014|SUPERIORITY_OR_OTHER||ratio of relative growth|1.0||||0.487|TWO_SIDED|90.0|0.89|1.12||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.12|0.89|0.487
74021828|NCT01955707|147596015|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|-0.02|||||TWO_SIDED|90.0|-0.14|0.1||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.10|-0.14|
74021829|NCT01955707|147596015|SUPERIORITY_OR_OTHER||ratio of relative growth|0.98||||0.402|TWO_SIDED|90.0|0.87|1.11||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.11|0.87|0.402
74021830|NCT01955707|147596016|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|-0.02|||||TWO_SIDED|90.0|-0.18|0.13||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to Day 5 using an autoregressive variance-covariance matrix structure. The model adjusts for for treatment, log baseline DWI volume, treatment time window, and tPA use.||0.13|-0.18|
74021831|NCT01955707|147596016|SUPERIORITY_OR_OTHER||ratio of relative growth|0.98||||0.394|TWO_SIDED|90.0|0.84|1.14||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.14|0.84|0.394
74021832|NCT01955707|147596017|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-0.25||||0.427|TWO_SIDED|90.0|-2.48|1.98||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at 24 hours. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||1.98|-2.48|0.427
74021833|NCT01955707|147596017|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|1.71||||0.896|TWO_SIDED|90.0|-0.52|3.94||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 5. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||3.94|-0.52|0.896
74021834|NCT01955707|147596017|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|3.15||||0.989|TWO_SIDED|90.0|0.89|5.4||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 30. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||5.40|0.89|0.989
74021835|NCT01955707|147596017|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|1.93||||0.915|TWO_SIDED|90.0|-0.38|4.25||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 90. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||4.25|-0.38|0.915
74021836|NCT01955707|147596018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.564|TWO_SIDED|90.0|0.55|1.45||One sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 5. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||1.45|0.55|0.564
73836834|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|2.4|||||TWO_SIDED|95.0|0.48|12.35||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||12.35|0.48|
74021837|NCT01955707|147596018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.077|TWO_SIDED|90.0|0.8|2.1||One-sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 30. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||2.10|0.80|0.077
74021838|NCT01955707|147596018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.243|TWO_SIDED|90.0|0.71|1.86||One -sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of the distribution of mRS scores at Day 90. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||1.86|0.71|0.243
74021839|NCT01955707|147596019|SUPERIORITY_OR_OTHER||Adjusted mean|0.68||||0.455|TWO_SIDED|90.0|-9.19|10.56||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 5. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||10.56|-9.19|0.455
74021840|NCT01955707|147596019|SUPERIORITY_OR_OTHER||Adjusted mean|1.21||||0.42|TWO_SIDED|90.0|-8.76|11.19||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 30. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||11.19|-8.76|0.420
74021841|NCT01955707|147596019|SUPERIORITY_OR_OTHER||Adjusted mean|3.56||||0.283|TWO_SIDED|90.0|-6.64|13.75|||repeated measures mixed effects model|||Analysis of Barthel Index at Day 90/Final Visit. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||13.75|-6.64|0.283
74021842|NCT01817790|147596021|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.36||||0.0024|TWO_SIDED|95.0|-0.59|-0.13||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in Daily rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.13|-0.59|0.0024
74021843|NCT01817790|147596022|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.33||||0.0057|TWO_SIDED|95.0|-0.56|-0.1||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.10|-0.56|0.0057
74021844|NCT01817790|147596023|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.41||||0.0009||95.0|-0.65|-0.17||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.17|-0.65|0.0009
74021845|NCT01817790|147596024|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0117|TWO_SIDED|95.0|-0.19|-0.02||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.||-0.02|-0.19|0.0117
74021846|NCT01817790|147596025|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.15||||0.0005||95.0|-0.23|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.23|0.0005
74021847|NCT01817790|147596026|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.13||||0.0023||95.0|-0.22|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Tearing/Watering between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.22|0.0023
74021848|NCT01817790|147596027|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.18|||<|0.0001||95.0|-0.26|-0.09||p-value was nor adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Tearing/watering between the Fluticasone nasal spray and the placebo nasal spray.||-0.09|-0.26|<0.0001
74021849|NCT01817790|147596028|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0304||95.0|-0.18|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.||-0.01|-0.18|0.0304
74021850|NCT01817790|147596029|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0361||95.0|-0.19|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.||-0.01|-0.19|0.0361
74021851|NCT01817790|147596030|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.28||||0.0129|TWO_SIDED|95.0|-0.5|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM iTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.50|0.0129
74021852|NCT01817790|147596031|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.14||||0.0002|TWO_SIDED|95.0|-0.22|-0.07||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in rNCSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.07|-0.22|0.0002
74021853|NCT01817790|147596032|SUPERIORITY_OR_OTHER|||||||0.0118||95.0||||p-value was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Using this test controlling for investigative site. The response variable lied on ordinal scale of measurement.||Null hypothesis was that no difference exists in the end of treatment assessment of response between the Fluticasone nasal spray and the placebo nasal spray.||||0.0118
74021854|NCT01817790|147596033|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.01||||0.8586|TWO_SIDED|95.0|-0.12|0.1|||ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in objective assessment of conjunctival redness between the Fluticasone nasal spray and the placebo nasal spray.||0.10|-0.12|0.8586
74021855|NCT01817790|147596034|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.29||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in MiniRQLQ scores between the Fluticasone nasal spray and the placebo nasal spray.||-0.29|-0.65|<0.0001
74081361|NCT00112437|147714536|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.68||||0.161|TWO_SIDED|95.0|-20.58|17.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||17.23|-20.58|0.161
74081362|NCT00112437|147714536|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.58|||||TWO_SIDED|95.0|-20.99|17.82||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||17.82|-20.99|
74081363|NCT00112437|147714536|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|46.9|||||TWO_SIDED|95.0|22.35|71.44||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||71.44|22.35|
74081364|NCT00112437|147714537|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.1|||<=|0.001|TWO_SIDED|95.0|2.77|5.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||5.42|2.77|<=0.001
74081365|NCT00112437|147714537|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.48|||<=|0.001|TWO_SIDED|95.0|2.2|4.77||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||4.77|2.20|<=0.001
74088212|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.2||0.0086|TWO_SIDED|95.0|-0.91|-0.13|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.13|-0.91|0.0086
73836835|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|0.45|9.05||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||9.05|0.45|
73836836|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.13|5.14||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.14|0.13|
73836837|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.04|0.8||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.80|0.04|
73836838|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.12|2.03||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.03|0.12|
73836839|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|2.7|||||TWO_SIDED|95.0|0.48|14.92||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||14.92|0.48|
73836840|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.23|4.36||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.36|0.23|
73836841|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.31|4.84||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||4.84|0.31|
73836842|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.23|6.65||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||6.65|0.23|
74021856|NCT01817790|147596035|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.3||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Activities' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray||-0.30|-0.68|<0.0001
74021857|NCT01817790|147596036|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.64|-0.24||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Practical Problems' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.24|-0.64|<0.0001
74021858|NCT01817790|147596037|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.33||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Nose Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.33|-0.73|<0.0001
74021859|NCT01817790|147596038|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.23||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Eye Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.23|-0.65|<0.0001
74021860|NCT01817790|147596039|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.64|-0.21||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in 'Other Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.21|-0.64|<0.0001
74021861|NCT04596891|147596059|OTHER|Repeated measures ANOVA|F ratio|20.62|||<|0.001|TWO_SIDED|95.0|||||ANOVA||The F ratio is used to evaluate the main effect of time in the ANOVA in relation to the critical F ratio.|No control group, open trial for feasibility/safety||||<0.001
74021862|NCT04596891|147596059|OTHER|Paired-samples t-test (baseline to post-treatment)|paired-samples t-test|5.2||||0.002|TWO_SIDED|95.0|-1.79|12.93|||t-test, 2 sided|||||12.93|-1.79|0.002
74021863|NCT04596891|147596064|OTHER|ANOVA|F ratio|8.46|||<|0.001|TWO_SIDED|95.0|||||ANOVA||The F ratio is used to evaluate the main effect of time in the ANOVA in relation to the critical F ratio. If it exceeds the critical F ratio, the null hypothesis (no effect of time) is rejected.|||||<0.001
74021864|NCT03219164|147596081|NON_INFERIORITY|Non-inferiority of the 14-day treatment regimen was claimed if the lower bound of 1-sided 97.5% confidence limit of the treatment difference (14-day course group vs 28-day course group) was above the noninferiority margin of -20%.|Difference in percentage|-8.0|||||TWO_SIDED|95.0|-24.6|8.6|||||The difference in percentage between treatment groups, and the associated 95% CIs were constructed based on stratum-adjusted Mantel-Haenszel method using age as stratification factor.|||8.6|-24.6|
74021865|NCT03219164|147596083|OTHER||||||||||||||||||The historical pooled data from published results for the percentage of participants with successful PA eradication at 28 days post-treatment with TNS was estimated to be 77%.|||
74021866|NCT02338843|147596085|SUPERIORITY||Odds Ratio (OR)|7.95|||<|0.001|TWO_SIDED|95.0|4.76|13.3|||Regression, Logistic|Stratified logistic regression model. Adjusted by baseline MAP and APACHE II, vasopressin use and average NED 6 hours prior to randomization.||||13.3|4.76|<0.001
74021867|NCT01542307|147596092|SUPERIORITY_OR_OTHER|||||||0.674|||||||Wilcoxon (Mann-Whitney)|||||||0.674
74021868|NCT01542307|147596093|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
74021869|NCT01542307|147596094|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
74021870|NCT01542307|147596095|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
74081366|NCT00112437|147714537|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.75|||<=|0.001|TWO_SIDED|95.0|1.43|4.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||4.07|1.43|<=0.001
74021871|NCT01542307|147596096|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
74021872|NCT01542307|147596097|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
74021873|NCT01542307|147596098|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
74021874|NCT01542307|147596099|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fisher Exact|||||||0.16
74021875|NCT03783195|147596108|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.59||0.4|TWO_SIDED|95.0|-1.77|0.76||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.||0.76|-1.77|0.40
74021876|NCT03783195|147596109|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.93||0.71|TWO_SIDED|95.0|-3.33|2.57||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.||2.57|-3.33|0.71
74021877|NCT03783195|147596110|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.02|STANDARD_ERROR_OF_MEAN|4.8||0.0006|TWO_SIDED|95.0|-31.33|-10.72||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in VLDL-TG as compared to high GRS group.||-10.72|-31.33|0.0006
73898225|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|4.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898226|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|0.43|STANDARD_ERROR_OF_MEAN|0.605||0.473|TWO_SIDED|95.0|-0.755|1.625||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.625|-0.755|0.473
74021878|NCT03783195|147596111|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Median Difference (Net)|0.094|STANDARD_ERROR_OF_MEAN|0.17||0.59|TWO_SIDED|95.0|-0.27|0.46|||t-test, 2 sided|||This analysis focuses on the changes in the area under the curve (AUC) for measurements at different time points between the two GRS groups.||0.46|-0.27|0.59
74081367|NCT00112437|147714537|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.51||||0.536|TWO_SIDED|95.0|-1.84|0.83||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||0.83|-1.84|0.536
73836843|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.17|4.17||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.17|0.17|
74081368|NCT00112437|147714538|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.69|||<=|0.001|TWO_SIDED|95.0|3.25|6.12||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||6.12|3.25|<=0.001
74081369|NCT00112437|147714538|SUPERIORITY_OR_OTHER||Difference in Least Square Means|3.57|||<=|0.001|TWO_SIDED|95.0|2.18|4.97||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||4.97|2.18|<=0.001
73836844|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.3|||||TWO_SIDED|95.0|0.07|1.24||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.24|0.07|
73898227|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|4.25|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74021879|NCT03783195|147596112|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.06|STANDARD_ERROR_OF_MEAN|7.77||0.017|TWO_SIDED|95.0|-37.75|-4.38||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum triglycerides as compared to high GRS group.||-4.38|-37.75|0.017
73898228|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.686||0.813|TWO_SIDED|95.0|-1.187|1.512||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.512|-1.187|0.813
73898229|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|5.3|||TWO_SIDED|||||||||Week 48||||
73898230|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.672||0.421|TWO_SIDED|95.0|-1.863|0.78||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.780|-1.863|0.421
73898231|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|5.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898232|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.687||0.758|TWO_SIDED|95.0|-1.139|1.564||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.564|-1.139|0.758
73898233|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|5.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898234|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.815||0.511|TWO_SIDED|95.0|-2.14|1.066||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.066|-2.140|0.511
73898235|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|6.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898236|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.801||0.192|TWO_SIDED|95.0|-2.623|0.527||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.527|-2.623|0.192
74088213|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.48|-1.07|<.0001
73836845|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.3|||||TWO_SIDED|95.0|0.06|2.08||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.08|0.06|
73898237|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|6.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898238|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|0.69|STANDARD_ERROR_OF_MEAN|0.816||0.398|TWO_SIDED|95.0|-0.914|2.294||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.294|-0.914|0.398
73898239|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|5.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898240|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|0.97|STANDARD_ERROR_OF_MEAN|0.924||0.296|TWO_SIDED|95.0|-0.851|2.784||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.784|-0.851|0.296
73898241|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|6.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898242|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.907||0.706|TWO_SIDED|95.0|-2.126|1.442||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.442|-2.126|0.706
73898243|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|6.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898244|NCT02880956|147328881|SUPERIORITY||LS Mean of Difference|1.79|STANDARD_ERROR_OF_MEAN|0.929||0.055|TWO_SIDED|95.0|-0.036|3.617||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||3.617|-0.036|0.055
73898245|NCT02880956|147328881|SUPERIORITY||Effect size/pooled SD|-0.28|STANDARD_DEVIATION|6.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898246|NCT02880956|147328882|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.651|TWO_SIDED|95.0|-0.266|0.166||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.166|-0.266|0.651
74021880|NCT03783195|147596113|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.022|STANDARD_ERROR_OF_MEAN|0.16||0.89|TWO_SIDED|95.0|-0.37|0.33|||t-test, 2 sided|||This analysis focuses on the changes in the area under the curve (AUC) for measurements baseline and 3hr timepoints at week 0 and week 3 between the two GRS groups.||0.33|-0.37|0.89
74021881|NCT03783195|147596114|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-4.36|STANDARD_ERROR_OF_MEAN|4.62||0.36|TWO_SIDED|95.0|-14.28|5.55||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have less increase in HDL cholesterol as compared to high GRS group.||5.55|-14.28|0.36
74021882|NCT03783195|147596115|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.16||0.67|TWO_SIDED|95.0|-0.27|0.4|||t-test, 2 sided|||||0.40|-0.27|0.67
74021883|NCT03783195|147596116|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.03|STANDARD_ERROR_OF_MEAN|11.53||0.09|TWO_SIDED|95.0|-45.76|3.69||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in LDL cholesterol as compared to high GRS group.||3.69|-45.76|0.09
74021884|NCT03783195|147596117|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.13||0.69|TWO_SIDED|95.0|-0.24|0.34|||t-test, 2 sided|||||0.34|-0.24|0.69
74021885|NCT03783195|147596118|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-29.61|STANDARD_ERROR_OF_MEAN|15.28||0.07|TWO_SIDED|95.0|-62.39|3.17||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in total cholesterol as compared to high GRS group.||3.17|-62.39|0.07
74021886|NCT03783195|147596119|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.036|STANDARD_ERROR_OF_MEAN|0.14||0.8|TWO_SIDED|95.0|-0.26|0.33|||t-test, 2 sided|||||0.33|-0.26|0.80
74021887|NCT03783195|147596120|OTHER||Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.25||0.17|TWO_SIDED|95.0|-0.18|0.91||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum uric acid as compared to high GRS group.||0.91|-0.18|0.17
74021888|NCT03783195|147596121|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.217|STANDARD_ERROR_OF_MEAN|0.17||0.22|TWO_SIDED|95.0|-0.58|0.15|||t-test, 2 sided|||||0.15|-0.58|0.22
74021889|NCT03783195|147596122|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.007||0.04|TWO_SIDED|95.0|-0.03|-0.0009||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum ALT as compared to high GRS group.||-0.0009|-0.03|0.04
74021890|NCT03783195|147596123|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.19||0.53|TWO_SIDED|95.0|-0.52|0.28|||t-test, 2 sided|||||0.28|-0.52|0.53
74021891|NCT03783195|147596124|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|20.57|STANDARD_ERROR_OF_MEAN|17.5||0.25|TWO_SIDED|95.0|-16.9|58.08||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum AST as compared to high GRS group.||58.08|-16.9|0.25
74021892|NCT03783195|147596125|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2|TWO_SIDED|95.0|-0.59|0.13|||t-test, 2 sided|||||0.13|-0.59|0.20
74021893|NCT03783195|147596126|OTHER||Mean Difference (Net)|28.95|STANDARD_ERROR_OF_MEAN|21.78||0.21|TWO_SIDED|95.0|-17.76|75.67||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum ALP as compared to high GRS group.||75.67|-17.76|0.21
74021894|NCT03783195|147596127|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.12||0.67|TWO_SIDED|95.0|-0.214|0.321|||t-test, 2 sided|||||0.321|-0.214|0.67
74081370|NCT00112437|147714538|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.82|||<=|0.001|TWO_SIDED|95.0|1.39|4.25||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||4.25|1.39|<=0.001
74021895|NCT03783195|147596128|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED|95.0|-0.12|0.28||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum GGT as compared to high GRS group.||0.28|-0.12|0.41
74021896|NCT03783195|147596129|OTHER|Both groups received the same intervention; however, their genetic make-up was different|Mean Difference (Net)|-0.109|STANDARD_ERROR_OF_MEAN|0.15||0.49|TWO_SIDED|95.0|-0.44|0.22|||t-test, 2 sided|||||0.22|-0.44|0.49
74021897|NCT00951821|147596132|SUPERIORITY_OR_OTHER||Slope|-3.3||||0.46|TWO_SIDED|95.0|-12.1|5.5||Effect sizes were also calculated due to small sample size|Mixed Models Analysis||The reported statistic (-3.3) is the difference in the change from baseline to follow-up between the two treatment arms, estimated in a mixed effect regression model.|||5.5|-12.1|.46
74021898|NCT00951821|147596133|SUPERIORITY_OR_OTHER||Slope|0.4||||0.75|TWO_SIDED|95.0|-2.36|3.06|||Mixed Models Analysis||The statistic provided (0.4) is the difference in the change in BDI score from baseline to follow-up by treatment group.|||3.06|-2.36|.75
74021899|NCT03124459|147596151|SUPERIORITY||Mean Difference (Final Values)|13.5|STANDARD_ERROR_OF_MEAN|5.2||0.01|TWO_SIDED|90.0|4.9|22.1|||ANCOVA|||||22.1|4.9|0.01
74021900|NCT03124459|147596152|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.2||0.16|TWO_SIDED|90.0|-6.8|0.6|||ANCOVA|||||0.6|-6.8|0.16
74021901|NCT03124459|147596153|SUPERIORITY||Mean Difference (Final Values)|35.4|STANDARD_ERROR_OF_MEAN|23.5||0.13|TWO_SIDED|90.0|-3.2|74.0|||ANCOVA|||||74|-3.2|0.13
74021902|NCT03124459|147596154|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|5.5||0.73|TWO_SIDED|90.0|-7.1|10.9|||ANCOVA|||||10.9|-7.1|0.73
74021903|NCT03124459|147596155|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|4.7||0.51|TWO_SIDED|90.0|-4.6|10.9|||ANCOVA|||||10.9|-4.6|0.51
74021904|NCT03124459|147596160|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|3.9||0.63|TWO_SIDED|90.0|-8.4|4.6|||ANCOVA|||||4.6|-8.4|0.63
74021905|NCT01147926|147596238|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74021906|NCT00670709|147596252|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-07||95.0|||||t-test, 2 sided|||||||<0.0000001
74021907|NCT00670709|147596253|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005||95.0|||||t-test, 2 sided|||HD subjects vs control subjects||||<0.005
74021908|NCT00004054|147596285|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.81|TWO_SIDED|95.0|0.76|1.43|||Log Rank|||The original target sample size was 1440 patients with a requirement of 340 deaths to test the hypothesis of overall survival (OS) efficacy of the hormones and RT plus chemotherapy arm; the design is based on detecting a 6% absolute improvement in 5-year OS from 79% to 85%, or a 33% relative reduction in the yearly hazard rate, with 90% power and a 2-sided significance level of 0.05.||1.43|0.76|0.81
74021909|NCT00004054|147596286|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.82|TWO_SIDED|95.0|0.74|1.27|||Gray's test|2-sided significance level of 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.27|0.74|0.82
74021910|NCT00004054|147596287|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.09|TWO_SIDED|95.0|0.28|1.1|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.10|0.28|0.09
74021911|NCT00004054|147596288|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.42|TWO_SIDED|95.0|0.48|1.36|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.36|0.48|0.42
74021912|NCT00004054|147596289|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.61|TWO_SIDED|95.0|0.75|1.19|||Log Rank|2-sided significance level = 0.05|Cox proportional hazards model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.19|0.75|0.61
74021913|NCT00888238|147596341|SUPERIORITY_OR_OTHER||Least Squares Mean|1.7|||<|0.001||90.0|1.47|1.93|||ANOVA|||||1.93|1.47|<0.001
74021914|NCT00888238|147596342|SUPERIORITY_OR_OTHER||Least Squares Mean|1.3|||<|0.001||90.0|1.08|1.52|||ANOVA|||||1.52|1.08|<0.001
74021915|NCT01032629|147596343|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.4576|TWO_SIDED|95.0|0.78|1.12|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.||1.12|0.78|=0.4576
74021916|NCT01032629|147596343|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.0467|TWO_SIDED|95.0|0.68|1.0|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.||1.00|0.68|=0.0467
74021917|NCT01032629|147596343|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.112|TWO_SIDED|95.0|0.75|1.03|||Cox proportional hazard method|||Comparison for canagliflozin versus placebo is reported here.||1.03|0.75|0.1120
74021918|NCT01032629|147596344|SUPERIORITY||Difference of Least Square Mean|2.79|STANDARD_ERROR_OF_MEAN|2.224|=|0.21|TWO_SIDED|95.0|-1.571|7.154|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.||7.154|-1.571|=0.210
74021919|NCT01032629|147596344|SUPERIORITY||Difference of Least Square Mean|4.07|STANDARD_ERROR_OF_MEAN|2.261|=|0.072|TWO_SIDED|95.0|-0.368|8.504|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.||8.504|-0.368|=0.072
74021920|NCT01032629|147596345|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.67|0.97|||Regression, Logistic|||Comparison for canagliflozin versus placebo is reported here.||0.97|0.67|
74021921|NCT01032629|147596345|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.58|0.85|||Regression, Logistic|||Comparison for canagliflozin versus placebo is reported here.||0.85|0.58|
74021922|NCT01032629|147596346|OTHER||Difference of Least Square Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|95.0|-0.429|0.374||||||Comparison for canagliflozin versus placebo is reported here.||0.374|-0.429|
74021923|NCT01032629|147596346|OTHER||Difference of Least Square Mean|0.33|STANDARD_ERROR_OF_MEAN|0.206|||TWO_SIDED|95.0|-0.079|0.731||||||Comparison for canagliflozin versus placebo is reported here.||0.731|-0.079|
74021924|NCT01032629|147596347|OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|95.0|0.8|0.94||||||Comparison for canagliflozin versus placebo is reported here.||0.940|0.800|
74021925|NCT01032629|147596347|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.77|0.91||||||Comparison for canagliflozin versus placebo is reported here.||0.910|0.770|
74021926|NCT01032629|147596348|OTHER||Difference of Least Square Mean|1.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|0.599|2.755||||||Comparison for canagliflozin versus placebo is reported here.||2.755|0.599|
74021927|NCT01032629|147596348|OTHER||Difference of Least Square Mean|1.24|STANDARD_ERROR_OF_MEAN|0.553|||TWO_SIDED|95.0|0.16|2.328||||||Comparison for canagliflozin versus placebo is reported here.||2.328|0.160|
74021928|NCT01032629|147596349|OTHER||Difference of Least Square Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.045|||TWO_SIDED|95.0|-0.355|-0.177||||||Comparison for canagliflozin versus placebo is reported here.||-0.177|-0.355|
74021929|NCT01032629|147596349|OTHER||Difference of Least Square Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|95.0|-0.405|-0.227||||||Comparison for canagliflozin versus placebo is reported here.||-0.227|-0.405|
74021930|NCT01032629|147596350|OTHER||Difference of Least Square Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|-0.794|-0.374||||||Comparison for canagliflozin versus placebo is reported here.||-0.374|-0.794|
74021931|NCT01032629|147596350|OTHER||Difference of Least Square Mean|-0.73|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|95.0|-0.945|-0.523||||||Comparison for canagliflozin versus placebo is reported here.||-0.523|-0.945|
74021932|NCT01032629|147596351|OTHER||Difference of Least Square Mean|-2.96|STANDARD_ERROR_OF_MEAN|0.26||||95.0|-3.472|-2.454||||||Comparison for canagliflozin versus placebo is reported here.||-2.454|-3.472|
74021933|NCT01032629|147596351|OTHER||Difference of Least Square Mean|-3.61|STANDARD_ERROR_OF_MEAN|0.261|||TWO_SIDED|95.0|-4.125|-3.103||||||Comparison for canagliflozin versus placebo is reported here.||-3.103|-4.125|
74021934|NCT01032629|147596352|OTHER||Difference of Least Square Mean|-2.96|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|95.0|-3.998|-1.914||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-1.914|-3.998|
74021935|NCT01032629|147596352|OTHER||Difference of Least Square Mean|-4.53|STANDARD_ERROR_OF_MEAN|0.534|||TWO_SIDED|95.0|-5.579|-3.484||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-3.484|-5.579|
74021936|NCT01032629|147596352|OTHER||Difference of Least Square Mean|-0.82|STANDARD_ERROR_OF_MEAN|0.314|||TWO_SIDED|95.0|-1.437|-0.205||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-0.205|-1.437|
74021937|NCT01032629|147596352|OTHER||Difference of Least Square Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.316|||TWO_SIDED|95.0|-2.245|-1.007||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-1.007|-2.245|
74021938|NCT01032629|147596353|OTHER||Hodges-Lehman Estimate|0.02|||||TWO_SIDED|95.0|-0.04|0.07||||||Comparison for canagliflozin versus placebo is reported here.||0.070|-0.040|
74021939|NCT01032629|147596353|OTHER||Hodges-Lehman Estimate|0.02|||||TWO_SIDED|95.0|-0.03|0.08||||||Comparison for canagliflozin versus placebo is reported here.||0.080|-0.030|
74021940|NCT01032629|147596354|OTHER||Difference of Least Square Mean|0.18|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|0.105|0.259||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.||0.259|0.105|
74021941|NCT01032629|147596354|OTHER||Difference of Least Square Mean|0.23|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|0.152|0.307||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.||0.307|0.152|
74021942|NCT01032629|147596354|OTHER||Difference of Least Square Mean|0.05|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|95.0|0.031|0.065||||||Statistical analysis (HDL-C)||0.065|0.031|
74021943|NCT01032629|147596354|OTHER||Difference of Least Square Mean|0.06|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|95.0|0.04|0.075||||||Statistical analysis (HDL-C) Comparison for canagliflozin versus placebo is reported here.||0.075|0.040|
74021944|NCT01032629|147596354|OTHER||Difference of Least Square Mean|0.11|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.046|0.17||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.||0.170|0.046|
74081371|NCT00112437|147714538|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.41||||0.585|TWO_SIDED|95.0|-1.85|1.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||1.04|-1.85|0.585
74021945|NCT01032629|147596354|OTHER||Difference of Least Square Mean|0.16|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.102|0.226||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.||0.226|0.102|
74021946|NCT01032629|147596355|OTHER||Difference of Least Square Mean|0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.04|0.076||||||||0.076|-0.040|
74021947|NCT01032629|147596355|OTHER||Difference of Least Square Mean|0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.023|0.094||||||||0.094|-0.023|
74021948|NCT00868790|147596364|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|-17.2||||0.013|TWO_SIDED|90.0|-28.3|-6.1|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-6.1|-28.3|0.013
74021949|NCT00868790|147596364|SUPERIORITY_OR_OTHER||LSM Difference|-23.4|||<|0.001|TWO_SIDED|90.0|-34.5|-12.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-12.4|-34.5|<0.001
73836846|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.79|1.97||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.97|0.79|
74021950|NCT00868790|147596364|SUPERIORITY_OR_OTHER||LSM Difference|-34.9|||<|0.001|TWO_SIDED|95.0|-44.8|-25.0|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-25.0|-44.8|<0.001
74021951|NCT00868790|147596365|SUPERIORITY_OR_OTHER||LSM Difference|-11.5||||0.002|TWO_SIDED|90.0|-17.5|-5.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-5.4|-17.5|0.002
74021952|NCT00868790|147596365|SUPERIORITY_OR_OTHER||LSM Difference|-21.8|||<|0.001|TWO_SIDED|90.0|-27.8|-15.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-15.8|-27.8|<0.001
74021953|NCT00868790|147596365|SUPERIORITY_OR_OTHER||LSM Difference|-36.0|||<|0.001|TWO_SIDED|90.0|-42.0|-30.0|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-30.0|-42.0|<0.001
74021954|NCT00868790|147596365|SUPERIORITY_OR_OTHER||LSM Difference|-20.0||||0.001|TWO_SIDED|90.0|-30.0|-10.1|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-10.1|-30.0|0.001
74021955|NCT00868790|147596366|SUPERIORITY_OR_OTHER||LSM Difference|-14.9||||0.174|TWO_SIDED|90.0|-33.0|3.2|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||3.2|-33.0|0.174
74021956|NCT00868790|147596366|SUPERIORITY_OR_OTHER||LSM Difference|-20.4||||0.063|TWO_SIDED|90.0|-38.4|-2.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-2.4|-38.4|0.063
74021957|NCT00868790|147596366|SUPERIORITY_OR_OTHER||LSM Difference|-78.1|||<|0.001|TWO_SIDED|90.0|-96.4|-59.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-59.8|-96.4|<0.001
74021958|NCT00868790|147596366|SUPERIORITY_OR_OTHER||LSM Difference|-49.4|||<|0.001|TWO_SIDED|90.0|-66.9|-31.8|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-31.8|-66.9|<0.001
74021959|NCT00868790|147596367|SUPERIORITY_OR_OTHER||LSM Difference|-0.8||||0.742|TWO_SIDED|90.0|-4.6|3.1|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||3.1|-4.6|0.742
74021960|NCT00868790|147596367|SUPERIORITY_OR_OTHER||LSM Difference|4.5||||0.06|TWO_SIDED|90.0|0.6|8.4|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||8.4|0.6|0.060
74021961|NCT00868790|147596367|SUPERIORITY_OR_OTHER||LSM Difference|7.8||||0.002|TWO_SIDED|90.0|3.8|11.7|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||11.7|3.8|0.002
74021962|NCT00868790|147596367|SUPERIORITY_OR_OTHER||LSM Difference|-3.9||||0.248|TWO_SIDED|90.0|-10.2|2.3|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||2.3|-10.2|0.248
74021963|NCT03377634|147596376|OTHER|Analysis of covariance on change in PROMIS Pain intensity, with group as fixed effect and controlling for baseline pain intensity||||||0.11|||||||ANCOVA|||||||0.11
74021964|NCT03377634|147596377|OTHER|Analysis of covariance on change in PROMIS pain interference, with group as fixed effect and controlling for baseline pain interference||||||0.99|||||||ANCOVA|||||||.99
74021965|NCT03377634|147596378|OTHER|Analysis of covariance on change in SPPB, with group as fixed effect and controlling for baseline SPPB||||||0.14|||||||ANCOVA|||||||.14
74021966|NCT03377634|147596379|OTHER|Analysis of covariance on change in weight, with group as fixed effect and controlling for baseline weight||||||0.11|||||||ANCOVA|||||||.11
74021967|NCT03377634|147596380|OTHER|Analysis of covariance on change in activity time, with group as fixed effect and controlling for baseline stepping time||||||0.65|||||||ANCOVA|||||||.65
74021968|NCT03377634|147596381|OTHER|Analysis of covariance on change in sitting time, with group as fixed effect and controlling for baseline sitting time||||||0.41|||||||ANCOVA|||||||.41
74021969|NCT03377634|147596382|OTHER|Analysis of covariance on change in sit to stand transitions, with group as fixed effect and controlling for baseline transitions||||||0.28|||||||ANCOVA|||||||.28
74081372|NCT00112437|147714539|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.09|||<=|0.001|TWO_SIDED|95.0|3.18|7.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||7.01|3.18|<=0.001
74081373|NCT00112437|147714539|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.56|||<=|0.001|TWO_SIDED|95.0|2.7|6.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||6.42|2.70|<=0.001
74081374|NCT00112437|147714539|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.43|||<=|0.001|TWO_SIDED|95.0|2.52|6.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||6.33|2.52|<=0.001
73898247|NCT02880956|147328882|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898248|NCT02880956|147328882|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.107||0.32|TWO_SIDED|95.0|-0.318|0.104||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.104|-0.318|0.320
73898249|NCT02880956|147328882|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
74081375|NCT00112437|147714539|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.04||||0.981|TWO_SIDED|95.0|-1.97|1.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||1.89|-1.97|0.981
74088214|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.94|-0.35|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.94|<.0001
73898250|NCT02880956|147328882|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.11||0.757|TWO_SIDED|95.0|-0.25|0.182||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.182|-0.250|0.757
73898251|NCT02880956|147328882|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898252|NCT02880956|147328882|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.121||0.984|TWO_SIDED|95.0|-0.241|0.236||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.236|-0.241|0.984
73898253|NCT02880956|147328882|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898254|NCT02880956|147328882|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.118||0.595|TWO_SIDED|95.0|-0.296|0.17||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.170|-0.296|0.595
73898255|NCT02880956|147328882|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
74088215|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.03|-0.41|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.03|<.0001
73898256|NCT02880956|147328882|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.122||0.67|TWO_SIDED|95.0|-0.187|0.291||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.291|-0.187|0.670
74021971|NCT01264939|147596393|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.52|||<|0.0001|TWO_SIDED|95.0|-5.97|-3.08||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.08|-5.97|<0.0001
74021972|NCT01264939|147596394|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.02|||<|0.0001|TWO_SIDED|95.0|-13.17|-6.86||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-6.86|-13.17|<0.0001
74021973|NCT01264939|147596395|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.72|-4.07||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.07|-7.72|<0.0001
74021974|NCT01264939|147596396|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.99|||<|0.0001|TWO_SIDED|95.0|1.47|2.68||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||2.68|1.47|<0.0001
74021975|NCT01264939|147596397|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
74021976|NCT01264939|147596398|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
74021977|NCT01264939|147596399|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.61|||<|0.0001|TWO_SIDED|95.0|-7.25|-3.96||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.96|-7.25|<0.0001
74021978|NCT01264939|147596400|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.67|||<|0.0001|TWO_SIDED|95.0|-6.28|-3.06||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.06|-6.28|<0.0001
74021979|NCT01264939|147596401|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||0.0006
74021980|NCT01264939|147596402|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
74021981|NCT01173653|147596459|SUPERIORITY_OR_OTHER||Chi square|23.02|||<|0.05|||||||Chi-squared|||||||<0.05
74029772|NCT03151148|147614039|SUPERIORITY||Geometric mean ratio (GMR)|1.78||||0.654|TWO_SIDED|95.0|0.141|22.607|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||22.607|0.141|0.654
74021982|NCT01818297|147596466|SUPERIORITY||Risk Difference (RD)|11.5|STANDARD_ERROR_OF_MEAN|10.5||0.14|ONE_SIDED|95.0|-5.8|||Due to early termination, the study was insufficiently powered to test the primary objective. This analysis is exploratory and descriptive in nature and cannot be considered conclusive.|Z-test|The Z-test (using an unpooled standard deviation, without continuity correction) was used to test the difference in responder rates between groups.|The Estimation Parameter is the difference between the responder rates in the Treatment and Control groups. The difference is calculated as Treatment - Control. A positive number represents a higher responder rate in the Treatment group.|The original sample size estimate for the primary objective was based on the following assumptions: 109 subjects in each arm with a responder rate of 22% in the Control group and 40% in the Treatment group, and a one-sided α= 0.05 using a Z test with unpooled variance, would result in 90% power. Because the study terminated early, the actual sample size (32 in Treatment, 30 in Control) resulted in 47% power under the same assumptions.|||-5.8|0.14
74021983|NCT00584870|147596472|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.39||0.001|TWO_SIDED|80.0|-1.67|-0.67||p-value was based on repeated measures model from pairwise comparisons, and statistical test was 1-sided with 0.1 significance level.|Repeated Measures Model|||LS mean difference was estimated from the repeated measures model with baseline, center, treatment, week and treatment-by-week interaction as fixed main effects and participant as random effect.||-0.67|-1.67|0.001
74021984|NCT02901431|147596548|SUPERIORITY||Difference in Adjusted LSMeans|-0.16||||0.911|TWO_SIDED|90.0|-2.56|2.23|||Mixed Models Analysis|||||2.23|-2.56|0.911
74021985|NCT02901431|147596549|SUPERIORITY||Difference in adjused LSMean|0.29|||||TWO_SIDED|90.0|-1.85|2.43||||||Week 12||2.43|-1.85|
74021986|NCT02901431|147596549|SUPERIORITY||Difference in adjusted LSMean|-0.23|||||TWO_SIDED|90.0|-2.67|2.22||||||Week 24||2.22|-2.67|
74021987|NCT02901431|147596550|SUPERIORITY||Difference in adjusted LSMean|-0.22|||||TWO_SIDED|90.0|-2.36|1.92||||||Communication Domain Standard Score, Week 12||1.92|-2.36|
74021988|NCT02901431|147596550|SUPERIORITY||Difference in adjusted LSMean|0.71|||||TWO_SIDED|90.0|-1.6|3.02||||||Communication Domain Standard Score, Week 24||3.02|-1.60|
74021989|NCT02901431|147596550|SUPERIORITY||Difference in adjusted LSMean|0.51|||||TWO_SIDED|90.0|-2.1|3.12||||||Socialization Domain Standard Score, Week 12||3.12|-2.10|
74021990|NCT02901431|147596550|SUPERIORITY|Socialization Domain Standard Score, Week 24|Difference in adjusted LSMean|-0.61|||||TWO_SIDED|90.0|-3.74|2.51||||||||2.51|-3.74|
74021991|NCT02901431|147596550|SUPERIORITY|Daily Living Skills Domain Standard Score, Week 12|Difference in adjusted LSMean|2.14|||||TWO_SIDED|90.0|-0.63|4.9||||||||4.90|-0.63|
74021992|NCT02901431|147596550|SUPERIORITY|Daily Living Skills Domain Standard Score, Week 24|Differences in adjusted LSMean|0.18|||||TWO_SIDED|90.0|-2.87|3.22||||||||3.22|-2.87|
74021993|NCT02901431|147596556|SUPERIORITY||Difference of Adjusted LS Means|3.74|||||TWO_SIDED|90.0|0.78|6.7|||Mixed Models Analysis|||Week 12||6.70|0.78|
74081376|NCT00112437|147714540|SUPERIORITY_OR_OTHER||Difference in Least square means|1.73|||<=|0.001||95.0|0.46|3.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||3.01|0.46|<=0.001
74081377|NCT00112437|147714540|SUPERIORITY_OR_OTHER||Difference in Least square means|1.11||||0.028||95.0|-0.12|2.34||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||2.34|-0.12|0.028
74021994|NCT02901431|147596556|SUPERIORITY||Difference of Adjusted LS means|2.28|||||TWO_SIDED|90.0|-0.73|5.29||||||Week 24||5.29|-0.73|
74021995|NCT02901431|147596558|SUPERIORITY||Difference in Adjusted LS Means|0.01||||0.992|TWO_SIDED|90.0|-1.99|2.01|||Mixed Models Analysis|||||2.01|-1.99|0.992
74021996|NCT04672083|147596561|OTHER||||||<|0.05|||||||ANOVA|||"CPT31 dose proportionality will be examined across dose groups using a power model approach or ANOVA model, as appropriate.PK parameters will be analyzed using a power model that will have the following form: parameter = intercept × dose\^slope + random error.~Using the natural log (ln) transformation, a power model can be expressed as a linear regression equation: ln(parameter) = intercept + slope × ln(dose) + random error. For dose proportionality, the slope = 1; for dose independence, = 0."||||<0.05
74021997|NCT04672083|147596562|OTHER||||||<|0.05|||||||ANOVA|||"CPT31 dose proportionality will be examined across dose groups using a power model approach or ANOVA model, as appropriate.PK parameters will be analyzed using a power model that will have the following form: parameter = intercept × dose\^slope + random error.~Using the natural log (ln) transformation, a power model can be expressed as a linear regression equation: ln(parameter) = intercept + slope × ln(dose) + random error. For dose proportionality, the slope = 1; for dose independence, = 0."||||<0.05
74021998|NCT04672083|147596563|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% confidence interval for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
74021999|NCT04672083|147596564|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
73898257|NCT02880956|147328882|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898258|NCT02880956|147328883|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.112||0.722|TWO_SIDED|95.0|-0.26|0.18||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.180|-0.260|0.722
73898259|NCT02880956|147328883|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.86|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898260|NCT02880956|147328883|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.109||0.878|TWO_SIDED|95.0|-0.232|0.198||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.198|-0.232|0.878
73898261|NCT02880956|147328883|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898262|NCT02880956|147328883|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.112||0.535|TWO_SIDED|95.0|-0.151|0.29||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.290|-0.151|0.535
73898263|NCT02880956|147328883|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898264|NCT02880956|147328883|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_ERROR_OF_MEAN|0.129||0.916|TWO_SIDED|95.0|-0.266|0.239||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.239|-0.266|0.916
73898265|NCT02880956|147328883|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898266|NCT02880956|147328883|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.126||0.511|TWO_SIDED|95.0|-0.33|0.165||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.165|-0.330|0.511
73898267|NCT02880956|147328883|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898268|NCT02880956|147328883|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.129||0.771|TWO_SIDED|95.0|-0.217|0.292||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.292|-0.217|0.771
73898269|NCT02880956|147328883|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||Week 96||||
73898270|NCT02880956|147328884|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.086||0.903|TWO_SIDED|95.0|-0.159|0.18||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.180|-0.159|0.903
73898271|NCT02880956|147328884|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898272|NCT02880956|147328884|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.084||0.811|TWO_SIDED|95.0|-0.185|0.145||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.145|-0.185|0.811
73898273|NCT02880956|147328884|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|0.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898274|NCT02880956|147328884|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.086||0.775|TWO_SIDED|95.0|-0.145|0.194||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.194|-0.145|0.775
73898275|NCT02880956|147328884|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898276|NCT02880956|147328884|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.273|TWO_SIDED|95.0|-0.337|0.096||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.096|-0.337|0.273
73898277|NCT02880956|147328884|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898278|NCT02880956|147328884|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.108||0.74|TWO_SIDED|95.0|-0.248|0.176||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.176|-0.248|0.740
74081378|NCT00112437|147714540|SUPERIORITY_OR_OTHER||Difference in Least square means|0.2||||0.804||95.0|-1.1|1.49||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||1.49|-1.10|0.804
74081379|NCT00112437|147714540|SUPERIORITY_OR_OTHER||Difference in Least square means|-1.15|||||TWO_SIDED|95.0|-2.46|0.15||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||0.15|-2.46|
74081380|NCT00112437|147714541|SUPERIORITY_OR_OTHER||Difference in Least square means|2.9|||<=|0.001|TWO_SIDED|95.0|1.34|4.46||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||4.46|1.34|<=0.001
74081381|NCT00112437|147714541|SUPERIORITY_OR_OTHER||Difference in Least square means|2.09|||<=|0.001||95.0|0.59|3.6||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||3.60|0.59|<=0.001
74081382|NCT00112437|147714541|SUPERIORITY_OR_OTHER||Difference in Least square means|1.53||||0.094||95.0|-0.01|3.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||3.07|-0.01|0.094
74081383|NCT00112437|147714541|SUPERIORITY_OR_OTHER||Difference in Least square means|-2.95||||||95.0|-4.5|-1.4||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||-1.40|-4.50|
74081384|NCT00112437|147714542|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-47.21|||<=|0.001||95.0|-64.51|-29.9||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-29.90|-64.51|<=0.001
74081385|NCT00112437|147714542|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-33.67|||<=|0.001||95.0|-51.44|-15.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-15.91|-51.44|<=0.001
73836847|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.38|0.88||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.88|0.38|
73836848|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.27|0.77||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.77|0.27|
74022000|NCT04672083|147596565|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
74022001|NCT04672083|147596566|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
74022002|NCT04672083|147596567|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
74022003|NCT04672083|147596568|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantification.||||<0.05
74022004|NCT04672083|147596569|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation||||<0.05
74022005|NCT04672083|147596570|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation||||<0.05
74022006|NCT04672083|147596571|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
74022007|NCT00046228|147596583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.551||95.0|0.67|1.23||The null hypothesis was tested at the significance level of 0.049. If it is significant, the significance level of null hypotheses tested in the analyses 2 and 3 will be adjusted according to the modified Hochberg approach.|Log Rank|Independent Clinical Endpoints Committee confirmed components of primary endpoint except for death \& resuscitated v fib assessed by the investigator)||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI group versus the Primary PCI group is 15% in lower risk, 25% in medium risk, and 35% in high risk, the power of this comparison (1,000 subjects per group) is 83.4 %.||1.23|0.67|0.551
74022008|NCT00046228|147596583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.858||95.0|0.72|1.31|||Log Rank|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the Abciximab facilitated PCI versus the Primary PCI group is 12.7%, in lower risk, 17.9% in medium risk, and 25.0% in high risk, the power of this comparison (1000 subjects per group) is 54.1%||1.31|0.72|0.858
74022009|NCT00046228|147596583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.676||95.0|0.69|1.27|||Log Rank|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI versus the abciximab facilitated PCI group is 2.6% in lower risk, 8.7% in medium risk, and 13.3% in high risk, the power of this comparison (1,000 subjects per group) is 13.5%.||1.27|0.69|0.676
74022010|NCT00046228|147596584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.247||95.0|0.57|1.16|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.||1.16|0.57|0.247
74022011|NCT00046228|147596584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.278||95.0|0.58|1.17|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.||1.17|0.58|0.278
74022012|NCT00046228|147596584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.944||95.0|0.68|1.43|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in complications of MI within 90 days.||1.43|0.68|0.944
74022013|NCT00046228|147596585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.494||95.0|0.74|1.84|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.||1.84|0.74|0.494
74022014|NCT00046228|147596585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.338||95.0|0.79|1.95|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.||1.95|0.79|0.338
74088216|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.15|<.0001
73836849|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|0.85|4.9||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.90|0.85|
74022015|NCT00046228|147596585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.781||95.0|0.61|1.45|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in 90-day all cause mortality.||1.45|0.61|0.781
74022016|NCT00046228|147596586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.016||95.0|1.08|2.1|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution \>70% from baseline.||2.10|1.08|0.016
74022017|NCT00046228|147596586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.67||95.0|0.76|1.52|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution \>70% from baseline.||1.52|0.76|0.670
74022018|NCT00046228|147596586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.042||95.0|1.01|1.93|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in ST-segment resolution \>70% from baseline.||1.93|1.01|0.042
74022019|NCT00046228|147596587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.603||95.0|0.62|1.32|||Log Rank|||||1.32|0.62|0.603
74022020|NCT00046228|147596587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.765||95.0|0.73|1.52|||Log Rank|||||1.52|0.73|0.765
74022021|NCT00046228|147596587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.415||95.0|0.59|1.24|||Log Rank|||||1.24|0.59|0.415
74022022|NCT00046228|147596588|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.||||0.218
74022023|NCT00046228|147596588|SUPERIORITY_OR_OTHER|||||||0.497||95.0|||||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.||||0.497
74022024|NCT00046228|147596588|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of ICH.||||0.062
74022025|NCT00046228|147596589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.001||95.0|1.63|3.19|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.||3.19|1.63|<0.001
74022026|NCT00046228|147596589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.025||95.0|1.05|2.15|||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.||2.15|1.05|0.025
74022027|NCT00046228|147596589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.008||95.0|1.12|2.05|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of non-ICH TIMI bleeding events.||2.05|1.12|0.008
74081386|NCT00112437|147714542|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-35.94|||<=|0.001||95.0|-54.15|-17.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-17.74|-54.15|<=0.001
74022028|NCT00046228|147596590|SUPERIORITY_OR_OTHER|||||||0.439||95.0|||||Fisher Exact|||||||0.439
74022029|NCT00046228|147596590|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Fisher Exact|||||||0.438
74022030|NCT00046228|147596590|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
74081387|NCT00112437|147714542|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|17.51||||0.101|TWO_SIDED|95.0|-6.78|41.8||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||41.80|-6.78|0.101
74022031|NCT00046228|147596591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
74022032|NCT00046228|147596591|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||||||0.020
74022033|NCT00046228|147596591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
74022034|NCT00046228|147596592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.434||95.0|0.69|1.18|||Chi-squared|||||1.18|0.69|0.434
74022035|NCT00046228|147596592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.589||95.0|0.71|1.22|||Chi-squared|||||1.22|0.71|0.589
74022036|NCT00046228|147596592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.809||95.0|0.74|1.27|||Chi-squared|||||1.27|0.74|0.809
74022037|NCT02732951|147596606|OTHER||Adjusted Mean|16.45|STANDARD_ERROR_OF_MEAN|16.45||0.3199|TWO_SIDED|95.0|-16.23|49.13|||Mixed model for repeated measurements|Kenward-Roger approximation was used for denominator degrees of freedom.|Fixed effects of treatment, prior anti-diabetic macular oedema treatment status, visit, treatment by visit interaction, baseline, baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within patient errors.|Null hypothesis = The CSFT change from baseline at Week 12 is equal in both groups||49.13|-16.23|0.3199
74022038|NCT01252966|147596692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.14|TWO_SIDED|95.0|0.42|1.13|||Regression, Logistic|||Longitudinal logistic regression with fitted generalized estimating equations (GEE) was used to estimate an overall treatment effect odds ratio including both the EOT and 6-month time points and relevant covariates (e.g., baseline smoking rate, age, Shipley IQ score). The study (n=213) had 80% power to detect small to medium effects on quit rates (corresponding to Cohen's one-sample d=0.38).||1.13|0.42|0.14
74022039|NCT01252966|147596694|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.30
74022040|NCT01252966|147596695|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.30
74081388|NCT00112437|147714543|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-63.34|||<=|0.001||95.0|-88.32|-38.36||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||-38.36|-88.32|<=0.001
74081389|NCT00112437|147714543|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-39.29|||<=|0.001|TWO_SIDED|95.0|-65.4|-13.18||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||-13.18|-65.40|<=0.001
74081390|NCT00112437|147714543|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-23.98||||0.124|TWO_SIDED|95.0|-53.04|5.09||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||5.09|-53.04|0.124
74081391|NCT00112437|147714543|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.18|||||TWO_SIDED|95.0|-12.38|56.73|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||56.73|-12.38|
74081392|NCT00112437|147714544|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-16.71||||0.015||95.0|-36.03|2.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||2.61|-36.03|0.015
74081393|NCT00112437|147714544|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-8.51||||0.246||95.0|-27.31|10.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||10.29|-27.31|0.246
74081394|NCT00112437|147714544|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-1.79||||||95.0|-22.66|19.08|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||19.08|-22.66|
74081395|NCT00112437|147714544|SUPERIORITY_OR_OTHER||Difference in Least Square Means|21.74||||||95.0|-1.32|44.81|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||44.81|-1.32|
74088217|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0004|TWO_SIDED|95.0|-0.91|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.91|0.0004
74081396|NCT00112437|147714545|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-16.64||||0.002||95.0|-28.84|-4.44||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||-4.44|-28.84|0.002
74081397|NCT00112437|147714545|SUPERIORITY_OR_OTHER||Difference in Least Square Means|7.24||||0.852||95.0|-5.73|20.21||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||20.21|-5.73|0.852
74081398|NCT00112437|147714545|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.39||||||95.0|-13.69|12.92|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||12.92|-13.69|
74081399|NCT00112437|147714545|SUPERIORITY_OR_OTHER||Difference in Least Square Means|36.79||||||95.0|21.19|52.38|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||52.38|21.19|
74081400|NCT00112437|147714546|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-21.49||||0.011|TWO_SIDED|95.0|-39.55|-3.43||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||-3.43|-39.55|0.011
74081401|NCT00112437|147714546|SUPERIORITY_OR_OTHER||Difference in Least square means|13.31||||0.618||95.0|-7.1|33.71||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least square means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||33.71|-7.10|0.618
74081402|NCT00112437|147714546|SUPERIORITY_OR_OTHER||Difference in Least square means|7.77|||||TWO_SIDED|95.0|-13.46|29.01|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||29.01|-13.46|
74081403|NCT00112437|147714546|SUPERIORITY_OR_OTHER||Difference in Least Square Means|49.23|||||TWO_SIDED|95.0|23.86|74.59|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||74.59|23.86|
74081404|NCT00112437|147714547|SUPERIORITY_OR_OTHER||Difference in Least Square Means|6.45|||||TWO_SIDED|95.0|3.38|9.53||||||In postmenopausal women with osteoporosis assess the time course of resolution of effect on lumbar spine BMD during the 12 month extension following 24 months of treatment with odanacatib once weekly. The primary objective was to assess the resolution of effect, on lumbar spine BMD, for the participants who received odanacatib 50 mg for 3 years compared to those who received odanacatib 50 mg in the 2nd year and switched to placebo for the 3rd year extension.||9.53|3.38|
74081405|NCT00112437|147714548|SUPERIORITY_OR_OTHER||Difference in Least Square Means|6.31|||||TWO_SIDED|95.0|3.44|9.17||||||||9.17|3.44|
74081406|NCT00112437|147714549|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.71|||||TWO_SIDED|95.0|-0.16|5.57||||||||5.57|-0.16|
74081407|NCT00112437|147714550|SUPERIORITY_OR_OTHER||Difference in Least Square Means|8.13|||||TWO_SIDED|95.0|3.8|12.46||||||||12.46|3.80|
74081408|NCT00112437|147714551|SUPERIORITY_OR_OTHER||Difference in Least Square Means|1.46|||||TWO_SIDED|95.0|-1.54|4.46||||||||4.46|-1.54|
74081409|NCT00112437|147714552|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.47|||||TWO_SIDED|95.0|-0.93|5.88||||||||5.88|-0.93|
74081410|NCT00112437|147714553|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-78.06|||||TWO_SIDED|95.0|-119.2|-36.92||||||||-36.92|-119.20|
74081411|NCT00112437|147714554|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-34.25|||||TWO_SIDED|95.0|-78.7|10.2||||||||10.20|-78.70|
74081412|NCT00112437|147714555|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-39.25|||||TWO_SIDED|95.0|-87.17|8.68||||||||8.68|-87.17|
74081413|NCT00112437|147714556|SUPERIORITY_OR_OTHER||Difference in Least Square Means|16.59|||||TWO_SIDED|95.0|-5.67|38.85||||||||38.85|-5.67|
74081414|NCT00112437|147714557|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-5.43|||||TWO_SIDED|95.0|-42.04|31.18||||||||31.18|-42.04|
74081415|NCT00112437|147714558|SUPERIORITY_OR_OTHER||Difference in Least Square Means|49.1|||||TWO_SIDED|95.0|13.37|84.83||||||||84.83|13.37|
74081416|NCT00112437|147714559|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|209.44|||||TWO_SIDED|95.0|127.14|291.73||||||||291.73|127.14|
74081417|NCT01919112|147714659|OTHER|Regression models using interaction terms will used to assess for heterogeneity of intervention effects across the novel radiological variable corticobulbar tract (CBT)-lesion load, a combined measure of lesion size and location. For purposes of the analysis, the CBT-lesion load was dichotomized into 2 groups based on the median CBT-lesion load volume.||||||0.116||||||Interaction p-values will be considered statistically significant at the 0.15 level of significance given the relatively low power for tests of interaction to detect a true interaction.|2-way analysis of variance with interact|The tDCS intervention was the main variable of interest, PAS score the main outcome and CBT-lesion load was the interaction term used.||The aim for this analysis was to assess for effect modification of the trial intervention across the novel radiological variable corticobulbar tract-lesion load.||||0.116
74081418|NCT00538031|147714884|OTHER|||||||0.61|||||||Log Rank|||||||0.61
74081419|NCT00538031|147714885|OTHER|||||||0.95|||||||Log Rank|||||||0.95
74081420|NCT00924638|147714887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.4||||0.0006|TWO_SIDED|95.0|1.9|21.7|||Log Rank||A hazard ratio of \> 1 indicates that Continuous Monitoring is superior to Control in detecting AF.|||21.7|1.9|0.0006
74081421|NCT00924638|147714888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.3|||<|0.0001|TWO_SIDED|95.0|2.6|20.8|||Log Rank||A hazard ratio of \> 1 indicates that Continuous Monitoring is superior to Control in detecting AF.|||20.8|2.6|<0.0001
74081422|NCT00924638|147714889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.25|TWO_SIDED|95.0|0.35|1.32|||Log Rank||A hazard ratio of \< 1 indicates that the incidence rate of recurrent stroke or TIA is lower in the Continuous Monitoring arm compared to the Control arm.|||1.32|0.35|0.25
74081423|NCT00924638|147714890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8|||||TWO_SIDED|95.0|2.8|14.8|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the OAC drugs at the 12 months visit compared to the Control arm.|||14.8|2.8|
74081424|NCT00924638|147714891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.3|3.1|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the anti-arrhythmic drugs at the 12 months visit compared to the Control arm.|||3.1|-2.3|
73836850|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.49|2.48||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.48|0.49|
74081425|NCT00924638|147714892|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||||||0.11
74081426|NCT00924638|147714893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.33|TWO_SIDED|95.0|0.73|2.6|||Log Rank||A hazard ratio of \< 1 indicates that the incidence rate of cardiovascular or stroke/TIA related hospitalization is lower in the Continuous Monitoring arm compared to the Control arm.|||2.60|0.73|0.33
74081427|NCT01252953|147714900|OTHER|Time to first event|Rate Ratio|0.91||||0.004|TWO_SIDED|95.0|0.85|0.97|||Log Rank|||||0.97|0.85|0.004
74081428|NCT01252953|147714901|OTHER|Time to first event|Rate Ratio|0.93||||0.052|TWO_SIDED|95.0|0.86|1.0|||Log Rank|||||1|0.86|0.052
74081429|NCT01252953|147714902|OTHER|Time to first event|Rate Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.12||In accordance with the data analysis plan, if the outcome of a major atherosclerotic event did not reach significance, there was no hypothesis testing for presumed ischemic stroke, so no P value is given.||||||1.12|0.87|
74081430|NCT01252953|147714903|OTHER|Time to first event|Rate Ratio|0.93||||0.02|TWO_SIDED|95.0|0.88|0.99|||Log Rank|||||0.99|0.88|0.02
74081431|NCT01026402|147714913|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|50.0|||||||||||||50mg twice daily continuous dosing 20 evaluable patients|||||
74081432|NCT01026402|147714913|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|100.0|||||||||||||100mg once daily continuous dosing 16 evaluable patients|||||
74081433|NCT01026402|147714913|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|125.0|||||||||||||125mg twice daily intermittent dosing (2 days on, 5 days off) 29 evaluable patients|||||
74081434|NCT05604014|147714929|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
74081435|NCT05604014|147714930|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
74081436|NCT05604014|147714931|SUPERIORITY||Mean Difference (Final Values)|-1.44||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
74081437|NCT05604014|147714932|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
74081438|NCT00840203|147714933|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|88.6|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|88.6|
74081439|NCT00840203|147714934|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|82.8|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|82.8|
74081440|NCT00840203|147714935|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|94.0||||||90.0|83.0|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|83.0|
74081441|NCT00840203|147714936|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|98.3||||||90.0|91.5|106.0|||||Metabolite results presented for informational purposes only.|||106|91.5|
74081442|NCT00840203|147714937|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|86.7|110.0|||||Metabolite results presented for informational purposes only.|||110|86.7|
74081443|NCT00840203|147714938|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|86.1|106.0|||||Metabolite results presented for informational purposes only.|||106|86.1|
74081444|NCT03349567|147714943|SUPERIORITY||Incident rate ratio|0.99||||0.35|TWO_SIDED|95.0|0.98|1.01|||Mixed Models Analysis|Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antimicrobial prescription rates.||||1.01|0.98|0.35
74081445|NCT03349567|147714944|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|1.12|||||TWO_SIDED|95.0|0.93|1.35||||||||1.35|0.93|
74081446|NCT03349567|147714945|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|1.01|||||TWO_SIDED|95.0|0.81|1.27||||||||1.27|0.81|
74081447|NCT03349567|147714946|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|0.88|||||TWO_SIDED|95.0|0.58|1.34||||||||1.34|0.58|
74081448|NCT03349567|147714947|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|0.83|||||TWO_SIDED|95.0|0.53|1.29||||||||1.29|0.53|
74081449|NCT03349567|147714948|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
74081450|NCT03349567|147714948|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
73836851|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.2|1.45||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.45|0.20|
74081451|NCT03349567|147714949|SUPERIORITY|||||||0.46|||||||Regression, Logistic|Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antibiotic prescription rates.||||||0.46
74081452|NCT00841659|147714988|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|99.96||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
74081453|NCT00841659|147714989|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|93.58||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
74081454|NCT00841659|147714990|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.29||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
74081455|NCT00834405|147715003|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|106.0||||||90.0|98.0|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|98.0|
74081456|NCT00834405|147715004|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||115|100|
74081457|NCT00829452|147715006|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.03||||||90.0|89.11|103.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.49|89.11|
74081458|NCT00829452|147715007|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|95.34||||||90.0|90.82|100.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.09|90.82|
73836852|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.87|1.15||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.87|
74081459|NCT00829452|147715008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.98||||||90.0|92.73|101.42|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.42|92.73|
74081460|NCT00829452|147715009|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.78||||||90.0|89.34|109.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||109.23|89.34|
74081461|NCT00829452|147715010|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.59||||||90.0|94.62|100.66|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.66|94.62|
74081462|NCT01296841|147715011|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|We performed t-test statistics for univariate comparisons for continuous variables.||||||<0.05
74081463|NCT02227238|147715024|SUPERIORITY|Non-inferiority of DTG plus 2 NRTI's was to be declared if the lower bound of 95% confidence interval (CI) for the difference in snapshot response rates (DTG - LPV/RTV) is greater than - 12%. This was also performed using the Per-Protocol (PP) Population. If both analyses show non-inferiority, the hypothesis of antiviral effect of DTG + 2 NRTI's was superior to LPV/RTV + 2 NRTIs was to be tested.|Proportion difference|13.8|||<|0.001|TWO_SIDED|95.0|7.3|20.3|||Cochran-Mantel-Haenszel||Adjusted proportion difference, calculated as proportion on DTG minus that on LPV/RTV and based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline plasma HIV-1 RNA and number of fully active background NRTIs, has been presented.||Superiority would be declared if the lower end of the confidence interval was above 0%|20.3|7.3|<.001
74081464|NCT02227238|147715027|OTHER||Proportion difference|5.7|||||TWO_SIDED|95.0|2.2|9.3|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 24 has been presented.|||9.3|2.2|
74081465|NCT02227238|147715027|OTHER||Proportion difference|9.8|||||TWO_SIDED|95.0|5.3|14.4|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 48 has been presented.|||14.4|5.3|
74081466|NCT02227238|147715054|OTHER||Mean Difference (Net)|-0.171||||0.001|TWO_SIDED|95.0|-0.272|-0.069|||Multiple imputation||Mean difference at Week 24 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age|||-0.069|-0.272|0.0010
74081467|NCT02227238|147715054|OTHER||Mean Difference (Net)|-0.147||||0.01|TWO_SIDED|95.0|-0.259|-0.035|||'Multiple imputation||Mean difference at Week 48 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age|||-0.035|-0.259|0.0100
74081468|NCT02227238|147715055|OTHER||Mean Difference (Net)|-0.542|||<|0.0001|TWO_SIDED|95.0|-0.729|-0.356|||Multiple imputation||Estimates at Week 24 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.|||-0.356|-0.729|<0.0001
74081469|NCT02227238|147715055|OTHER||Mean Difference (Net)|-0.358||||0.0004|TWO_SIDED|95.0|-0.555|-0.161|||Multiple imputation||Estimates at Week 48 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.|||-0.161|-0.555|0.0004
74081470|NCT03966911|147715063|SUPERIORITY||Intercept from ANCOVA as agreement rate|88.0|||<|0.041|TWO_SIDED|91.8|86.05|89.95|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||89.95|86.05|<0.041
74081471|NCT03966911|147715063|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.96|||<|0.041|TWO_SIDED|91.8|86.13|89.8|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||89.80|86.13|<0.041
74081472|NCT03966911|147715063|SUPERIORITY||Intercept from ANCOVA as agreement rate|84.59||||0.041|TWO_SIDED|91.8|82.02|87.17|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||87.17|82.02|0.041
74081473|NCT03966911|147715063|SUPERIORITY||Intercept from ANCOVA as agreement rate|81.05|||<|0.041|TWO_SIDED|91.8|77.58|84.53|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||84.53|77.58|<0.041
74081474|NCT01395017|147715080|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.3864|TWO_SIDED|95.0|0.85|1.65||The log-rank test was used to test OS. As a sensitivity analysis, HR and its confidence interval was also provided for OS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors - treatment, ECOG PS, region, CA19-9 level (\< 1000 IU/mL or \>/=1000 IU/mL), and RT during trial (yes or no).||Using a 1-sided alpha=0.2, a population of 200 participants (100 GEM plus dasatinib and 100 GEM plus placebo) has 79% power to show an increase in median OS from 10 to 13.3 months (hazard ratio \[HR\] =0.75, assuming analysis of 135 deaths).||1.65|0.85|0.3864
74081475|NCT01395017|147715081|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.6761|TWO_SIDED|95.0|0.73|1.34||The log-rank test was used to test PFS. As a sensitivity analysis, HR and its confidence interval was also provided for PFS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors: treatment, ECOG PS, region, CA19-9 level (\< 1000 IU/mL or \>/=1000 IU/mL), and RT during trial (yes or no).||Trial has 88% power to show a median PFS increase from 5 to 7 months (with 1-sided alpha=0.15, total 176 events, HR=0.714).||1.34|0.73|0.6761
74081476|NCT02003391|147715092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6191|||<|0.0001|ONE_SIDED|95.0||-3.8503|||ANCOVA|||||-3.8503||<0.0001
74081477|NCT02272803|147715097|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.41|1.67|||||Hazard Ratio of E-Ld to Ld. Stratified by stage of disease (International Staging System 1 - 2 vs 3)|||1.67|0.41|
74081478|NCT02302716|147715151|NON_INFERIORITY_OR_EQUIVALENCE|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week HbA1c level for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|-0.04||||0.693|TWO_SIDED|95.0|-0.22|0.15|||Mixed Models Analysis|||||0.15|-0.22|0.693
74081479|NCT00557245|147715163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33|||<|0.001|TWO_SIDED|95.0|0.19|0.56||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.||0.56|0.19|<0.001
74081480|NCT00557245|147715163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.13|0.45||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.||0.45|0.13|<0.001
74081481|NCT00557245|147715164|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
74081482|NCT00557245|147715164|SUPERIORITY_OR_OTHER|||||||0.89|||||||Fisher Exact|||||||0.89
74081483|NCT00557245|147715168|SUPERIORITY_OR_OTHER|||||||0.24|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.||||||0.24
74081484|NCT00557245|147715168|SUPERIORITY_OR_OTHER|||||||0.49|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.||||||0.49
74081485|NCT00557245|147715169|SUPERIORITY_OR_OTHER|||||||0.32|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.||||||0.32
74081486|NCT00557245|147715169|SUPERIORITY_OR_OTHER|||||||0.66|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.||||||0.66
74081487|NCT00557245|147715170|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Regression, Logistic|Generalized estimating equations with logistic link to account for multiple pregnancies and multiple births||||||0.51
73836853|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.03|0.79|
74081488|NCT00557245|147715170|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Regression, Logistic|generalized estimating equations with logistic link to account for multiple pregnancies and multiple births||||||0.86
74081489|NCT00557245|147715171|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Models Analysis|linear mixed-effects model||||||0.42
74081490|NCT00557245|147715171|SUPERIORITY_OR_OTHER||Slope Difference over time|0.07||||0.08|||||||Mixed Models Analysis|Linear mixed-effects model|Placebo arm is the reference group.|||||0.08
74081491|NCT00557245|147715172|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.02
74081492|NCT00557245|147715172|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||<0.001
74081493|NCT00557245|147715173|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.35
74081494|NCT00557245|147715173|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.008
74081495|NCT01127087|147715193|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the RYGB Calcium oxalate (CaOx) Stone Formers arm.||||0.027
74081496|NCT01127087|147715193|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.||||0.14
74081497|NCT01127087|147715194|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the RYGB CaOx Stone Formers arm.||||0.018
74081498|NCT01127087|147715194|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.||||0.06
74081499|NCT00828321|147715224|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|94.16||||||90.0|85.08|104.21|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.21|85.08|
74081500|NCT00828321|147715225|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.21|108.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.6|96.21|
74081501|NCT00828321|147715226|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.34|108.58|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.58|96.34|
74081502|NCT00828321|147715227|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.52||||||90.0|92.63|104.79|||||This analysis was for informational purposes and was not used to establish bioequivalence.|||104.79|92.63|
74081503|NCT00828321|147715228|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.45||||||90.0|94.66|100.32|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.32|94.66|
74081504|NCT02034513|147715229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR \>1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.89|||<|0.0001|TWO_SIDED|95.0|0.85|0.94|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was \<1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 1: Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period.||0.94|0.85|<0.0001
74081505|NCT02034513|147715230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR \>1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.56|0.73|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was \<1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period.||0.73|0.56|<0.0001
74081506|NCT02034513|147715231|SUPERIORITY_OR_OTHER|||||||0.0016||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in both the maintenance periods. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes during the maintenance period.||||0.0016
74081507|NCT02034513|147715233|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 437 (n=220 for IDeg and n=217 for IGlar).|Treatment contrast|0.03|||||TWO_SIDED|95.0|-0.1|0.15||||||"Change from baseline in HbA1c at week 32 (treatment period 1). Before testing the primary endpoint, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as a prerequisite for testing the primary endpoint. Analysis was based on mixed model for repeated measurement (MMRM); treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates."||0.15|-0.10|
74081508|NCT02034513|147715233|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 410 (n=202 for IDeg and n=208 for IGlar).|Treatment contrast|0.11|||||TWO_SIDED|95.0|0.0|0.23||||||"Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was based on MMRM; treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates"||0.23|-0.00|
74081509|NCT04158687|147715301|SUPERIORITY||Least Square (LS) Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.8||0.6003|TWO_SIDED|95.0|-4.5|2.6|||Mixed model repeated measures (MMRM)|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||2.6|-4.5|0.6003
74081510|NCT04158687|147715301|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.8||0.392|TWO_SIDED|95.0|-2.0|5.0|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||5.0|-2.0|0.3920
74081511|NCT04158687|147715301|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.8||0.1444|TWO_SIDED|95.0|-0.9|6.0|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||6.0|-0.9|0.1444
74081512|NCT04158687|147715302|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8065|TWO_SIDED|95.0|-0.3|0.2|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.2|-0.3|0.8065
74081513|NCT04158687|147715302|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.2121|TWO_SIDED|95.0|-0.1|0.4|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.4|-0.1|0.2121
74081514|NCT04158687|147715302|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0264|TWO_SIDED|95.0|0.0|0.5|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.5|0.0|0.0264
74081515|NCT04158687|147715303|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6101|TWO_SIDED|95.0|-2.1|3.5|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||3.5|-2.1|0.6101
74081516|NCT04158687|147715303|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6237|TWO_SIDED|95.0|-3.4|2.1|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||2.1|-3.4|0.6237
74081517|NCT04158687|147715303|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.4||0.1764|TWO_SIDED|95.0|-4.6|0.8|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.8|-4.6|0.1764
74081518|NCT00834964|147715311|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|92.72|101.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.49|92.72|
74081519|NCT00834964|147715312|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.7||||||90.0|94.74|104.92|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.92|94.74|
74081520|NCT00834964|147715313|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|93.46|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.02|93.46|
74081521|NCT00834964|147715314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.29||||||90.0|91.96|100.82|||||Metabolite results not subjected to bioequivalence criteria; results are presented for informational purposes only.|||100.82|91.96|
74081522|NCT00834964|147715315|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.1||||||90.0|100.08|108.29|||||Metaboite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||108.29|100.08|
74081523|NCT00834964|147715316|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.52||||||90.0|97.3|103.84|||||Metabolite results were not subjected to bioequivalence criteria, results are presented for informational purposes only.|||103.84|97.30|
74081524|NCT01911429|147715350|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-8.0||||0.0003|TWO_SIDED|95.0|-12.4|-3.7|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."||-3.7|-12.4|0.0003
74081525|NCT01911429|147715350|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-7.7||||0.0006|TWO_SIDED|95.0|-12.1|-3.4|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."||-3.4|-12.1|0.0006
74081526|NCT01911429|147715351|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-0.47||||0.0003|TWO_SIDED|95.0|-0.73|-0.22|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.22|-0.73|0.0003
74081527|NCT01911429|147715351|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-0.42||||0.0015|TWO_SIDED|95.0|-0.67|-0.16|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.16|-0.67|0.0015
74081528|NCT01662960|147715359|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|2.2||||0.443|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.443
74081529|NCT01662960|147715360|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|0.4||||0.8|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.80
74081530|NCT01662960|147715361|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.002||||0.93|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.93
74081531|NCT01662960|147715363|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|10.7||||0.28|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.28
74081532|NCT01662960|147715364|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.36||||0.86|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.86
74081536|NCT01852799|147715462|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||bALP changes from baseline to cycle 1||||0.002
74081537|NCT01852799|147715462|OTHER||||||<|0.001|||||||t-test, 2 sided|||b-ALP changes from baseline to cycle 4||||<0.001
74081538|NCT01852799|147715462|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||DKK-1 changes from baseline to cycle 1||||0.005
74081539|NCT01852799|147715462|OTHER||||||<|0.001|||||||t-test, 2 sided|||DKK-1 changes from baseline to cycle 4||||<0.001
74081540|NCT00672984|147715497|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.43||||||90.0|-4.52|-0.34||||||||-0.34|-4.52|
74081541|NCT00672984|147715497|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.87||||||90.0|11.45|16.29||||||||16.29|11.45|
74081542|NCT00672984|147715498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.08||||||90.0|-11.37|-4.78||||||||-4.78|-11.37|
74081543|NCT00672984|147715498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.13||||||90.0|9.33|16.93||||||||16.93|9.33|
74081544|NCT00672984|147715499|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||||90.0|-1.07|3.03||||||||3.03|-1.07|
74081545|NCT00672984|147715499|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.11||||||90.0|8.97|13.24||||||||13.24|8.97|
74081546|NCT00672984|147715500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.64||||||90.0|-0.99|4.27||||||||4.27|-0.99|
74081547|NCT00672984|147715500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.8||||||90.0|7.63|13.97||||||||13.97|7.63|
74081548|NCT00672984|147715501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.76||||||90.0|-8.01|-5.51||||||||-5.51|-8.01|
74081549|NCT00672984|147715501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.73||||||90.0|3.08|6.38||||||||6.38|3.08|
74081550|NCT00672984|147715502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.85||||||90.0|-21.92|-17.78||||||||-17.78|-21.92|
74081551|NCT00672984|147715502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.44||||||90.0|1.77|5.11||||||||5.11|1.77|
74081552|NCT00672984|147715503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.32||||||90.0|11.75|18.89||||||||18.89|11.75|
74081553|NCT00672984|147715503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93||||||90.0|-2.77|4.63||||||||4.63|-2.77|
74081554|NCT00672984|147715504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|49.85||||||90.0|44.71|54.98||||||||54.98|44.71|
74081555|NCT00672984|147715504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.63||||||90.0|-0.41|7.66||||||||7.66|-0.41|
74081556|NCT02705716|147715524|OTHER||Least Square (LS) Mean Difference|-0.12||||0.5191|TWO_SIDED|95.0|-0.497|0.252|||ANCOVA|From ANCOVA Model, Response: change from baseline in Schiff sensitivity score Factors: treatment \& site Covariates: baseline Schiff sensitivity score|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.|||0.252|-0.497|0.5191
74081557|NCT00985751|147715532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the Synflorix/GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would|Difference in percentage|0.97|||||TWO_SIDED|95.0|-6.1|5.32||||||Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine (GSK 2189242A) combined with Synflorix™ vaccine (pooled groups) versus Synflorix™ vaccine (Synflorix/GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.||5.32|-6.1|
74081558|NCT00985751|147715533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would be express|Difference in percentage|0.97|||||TWO_SIDED|95.0|-6.1|5.32||||||Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine GSK 2189242A (pooled groups) versus Synflorix™ vaccine (GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.||5.32|-6.1|
74081559|NCT03867760|147715614|SUPERIORITY|The study was designed to detect a difference in pain intensity of at least 0.85 points corresponding to an effect size of 0.57 based on results from our pilot study. The sample size needed was 50 per group based on power of .80, alpha of .05.||||||0.809||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in addition to baseline pain medications in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain intensity than cancer survivors assigned to the relaxation intervention.||||0.809
74081560|NCT03867760|147715615|SUPERIORITY|||||||0.369||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in addition to baseline pain medications in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain interference than cancer survivors assigned to the relaxation intervention.||||0.369
74081561|NCT03867760|147715616|SUPERIORITY|||||||0.029||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in anxiety than cancer survivors assigned to the relaxation intervention.||||0.029
74081562|NCT03867760|147715617|SUPERIORITY|||||||0.236||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in depression than cancer survivors assigned to the relaxation intervention.||||0.236
74081563|NCT03867760|147715618|SUPERIORITY|||||||0.904||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in fatigue than cancer survivors assigned to the relaxation intervention.||||0.904
74081564|NCT03867760|147715619|SUPERIORITY|||||||0.936||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in sleep disturbance than cancer survivors assigned to the relaxation intervention.||||0.936
74081565|NCT03867760|147715620|SUPERIORITY|||||||0.02||||||An a priori significance level was set at 0.05.|t-test, 2 sided|||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention who experience a clinically meaningful improvement in pain intensity will not have a significantly higher pre-treatment treatment credibility and expectancy score than non-improvers.||||0.02
74081566|NCT00521586|147715622|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|2.8|||||TWO_SIDED|95.0|-1.8|7.4||||||A/H1N1 strain: Exact 2-sided, 95 percent (%) confidence intervals was computed based on the methodology by Chan and Zhang||7.4|-1.8|
74081567|NCT00521586|147715622|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|1.6|||||TWO_SIDED|95.0|-3.9|7.2||||||A/H3N2 strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.||7.2|-3.9|
74081568|NCT00521586|147715622|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|0.3|||||TWO_SIDED|95.0|-5.6|6.2||||||B strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.||6.2|-5.6|
74081569|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.74|||||TWO_SIDED|95.0|0.58|0.95||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.95|0.58|
74081570|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.93|0.66|
74081571|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.69|||||TWO_SIDED|95.0|0.55|0.87||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.87|0.55|
74081572|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.67|1.05||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.05|0.67|
74081573|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.86|||||TWO_SIDED|95.0|0.7|1.06||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.70|
74081574|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.75|||||TWO_SIDED|95.0|0.6|0.93||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.93|0.60|
74081575|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.63|0.95||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.95|0.63|
74081576|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.71|||||TWO_SIDED|95.0|0.59|0.86||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.86|0.59|
74081577|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.6|0.98||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.98|0.60|
74081578|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.58|0.88||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.88|0.58|
74081579|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.89|||||TWO_SIDED|95.0|0.74|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.08|0.74|
74081580|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.67|1.1||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.10|0.67|
74081581|NCT00521586|147715623|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.08||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.08|0.66|
74081582|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.83|1.34||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.34|0.83|
74081583|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.75|1.08||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.75|
74081584|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.28|0.92|
74081585|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.68|1.08||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.68|
74081586|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.88|1.3||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.30|0.88|
74081587|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.21||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.84|
74081588|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.06||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.78|
74081589|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.48||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.48|0.93|
74081590|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.86|1.17||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.17|0.86|
74081591|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.27||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.27|0.84|
74081592|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.21||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.87|
74081593|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.85|1.31||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.31|0.85|
74081594|NCT00521586|147715624|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.27||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.27|0.80|
74081595|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.18|0.87|
74081596|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.1||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.10|0.82|
74081597|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.88|1.21||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.88|
74081598|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.09|0.80|
74081599|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.84|1.22||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.22|0.84|
74081600|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.12|0.77|
74081601|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.11|0.85|
74081602|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.07|0.81|
74081603|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.81|1.11||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.11|0.81|
74081604|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.06||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.79|
74081605|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.80|
74081606|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.12|0.77|
74081607|NCT00521586|147715633|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.09||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.09|0.74|
74081608|NCT03234907|147715652|SUPERIORITY||Risk Difference (RD)|-5.2|||=|0.347|TWO_SIDED|95.0|-17.2|6.8||P-value was based on CHW test, based on weighted CMH chi-square test, with stratification according to: (1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).|Cui-Hung-Wang (CHW) test||Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.|||6.8|-17.2|=0.347
74081609|NCT03234907|147715653|SUPERIORITY||Risk Difference (RD)|-2.7|||=|0.531|TWO_SIDED|95.0|-11.5|6.0||P-value based on Cochran-Mantel-Haenszel, weighted CMH chi-square test, with stratification according to:(1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).|Cochran-Mantel-Haenszel||Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.|||6.0|-11.5|=0.531
74081610|NCT00642993|147715654|SUPERIORITY_OR_OTHER||Difference in means|0.41||||0.187|TWO_SIDED|95.0|-0.2|1.03|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||1.03|-0.20|0.187
74081611|NCT00642993|147715655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.14|TWO_SIDED|95.0|0.28|1.2|||Cochran-Mantel-Haenszel|The P-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.||||1.20|0.28|0.140
74081612|NCT00642993|147715656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.515|TWO_SIDED|95.0|0.24|9.93|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.||||9.93|0.24|0.515
74081613|NCT00642993|147715657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.543|TWO_SIDED|95.0|-1.2|0.63|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||0.63|-1.20|0.543
74081614|NCT00642993|147715658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.231|TWO_SIDED|95.0|-0.09|0.35|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||0.35|-0.09|0.231
74081615|NCT02664415|147715660|SUPERIORITY|||||||1|||||||Fisher Exact|This is to confirm that the p-value from Fisher's Exact test was 1.000.||||||1.000
74081616|NCT02664415|147715661|SUPERIORITY|||||||0.051|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA \>= 20 copies/mL between arms.||||0.051
74081617|NCT02664415|147715661|SUPERIORITY|||||||0.01|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA \>= 1000 copies/mL between arms.||||0.01
74081618|NCT02664415|147715662|SUPERIORITY|||||||0.027||||||This is a p-value, comparing HIV-1 RNA levels at first detection between arms.|Wilcoxon (Mann-Whitney)|||||||0.027
74081619|NCT02664415|147715662|SUPERIORITY|||||||0.588||||||This is p-value, comparing HIV-1 RNA levels at ART resumption between arms.|Wilcoxon (Mann-Whitney)|||||||0.588
74081620|NCT02664415|147715663|SUPERIORITY|||||||0.031|||||||Log Rank|||||||0.031
74081621|NCT02664415|147715665|SUPERIORITY|||||||0.693|||||||Wilcoxon (Mann-Whitney)|||||||0.693
74081622|NCT02664415|147715666|SUPERIORITY|||||||0.15||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the VRC01 arm.||||0.15
74081623|NCT02664415|147715666|SUPERIORITY|||||||0.04||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the placebo arm.||||0.04
74081624|NCT02664415|147715666|SUPERIORITY|||||||0.002||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the VRC01 arm.||||0.002
74081625|NCT02664415|147715666|SUPERIORITY|||||||0.22||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the placebo arm.||||0.22
74081626|NCT02664415|147715666|SUPERIORITY|||||||0.05|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA atbaseline ATI and 6 months after ART resumption within the VRC01 arm.||||0.05
74081627|NCT02664415|147715666|SUPERIORITY|||||||0.22|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA at baeline ATI versus 6 months after ART resumption in the placebo arm||||0.22
74081628|NCT02664415|147715669|SUPERIORITY|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at baseline ATI||||0.961
74081629|NCT02664415|147715669|SUPERIORITY|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at ART resumption||||0.805
74081630|NCT02664415|147715669|SUPERIORITY|||||||0.221|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within VRC01 arm.||||0.221
74081631|NCT02664415|147715669|SUPERIORITY|||||||0.5|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within Placebo arm.||||0.500
74081632|NCT02664415|147715670|SUPERIORITY|||||||0.522|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups at baseline ATI.||||0.522
74081633|NCT02664415|147715670|SUPERIORITY|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||A comparison between groups at ART resumption.||||0.961
74081634|NCT02664415|147715670|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within VRC01 group.||||0.002
74081635|NCT02664415|147715670|SUPERIORITY|||||||0.043|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within Placebo group.||||0.043
74081636|NCT00128219|147715671|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.044|TWO_SIDED|95.0|1.0|58.0||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|The study was multi-center, and the Cox model was stratified by geographic region of the participating clinical sites.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first acquisition of vaginal type III GBS was analyzed by fitting a Cox Proportional Hazards model stratified by region to the data. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||58|1|0.044
74081637|NCT00128219|147715696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.12|TWO_SIDED|95.0|0.917|2.34||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportions always vaginal GBS-III negative by arm to a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the 2-sided 5% level Fisher's exact, with GBS III-TT arm in the numerator and Td arm in the denominator so \<1 favors the GBS III-TT arm.|A two-sided 5% level Fisher's exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher's exact test was inverted to obtain a 95% confidence interval for the odds ratio.||2.34|0.917|0.120
74081638|NCT00128219|147715697|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.089||95.0|-7.0|61.0||Significance was set at .05 without adjustment for multiplicity. Exchangeable correlation structure and GEE were used for repeated measures.|Binomial regression, log-linear link|The Wald test of treatment effect was used to test no difference in proportion of GBS III pos. by arm against a 2-sided alternative of a difference.|Estimate of vaccine efficacy and 95% CI were obtained by transforming the estimate of log relative risk for treatment effect and the robust Wald CI in the log-linear binomial regression model fit to the proportion of vaginal type III GBS swabs.|The proportion of vaginal swabs that were GBS III culture positive was estimated from a GEE model fit with binomial family, log-link, and exchangeable correlation. Point and robust interval estimates for vaccine efficacy, were obtained by transforming those for treatment effect in this model, and used to test the hypothesis of no efficacy.||61|-7|0.089
74081639|NCT00128219|147715698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.256|TWO_SIDED|95.0|0.18|1.45||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportion persistently colonized by arm against a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the two-sided 5% level Fisher's exact test. The GBS III-TT arm is in the numerator and Td arm in the denominator, so a value \<1 favors the GBS III-TT arm.|A two-sided 5% level Fisher's exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher's exact test was inverted to obtain a 95% confidence interval for the odds ratio.||1.45|0.18|0.256
74081640|NCT02986139|147715711|SUPERIORITY||LS Mean Difference|-4.0||||0.048|TWO_SIDED|95.0|-8.0|0.0|||Mixed effects analysis of variance model|||A mixed effects analysis of variance model was used to assess injection site pain with the new formulation of etanercept as the test treatment and the commercial formulation of etanercept as the reference treatment. Treatment, study period, sequence, and disease indication were evaluated as fixed effect covariates, and subject within sequence was included as a random effect.||-0.0|-8.0|0.048
74081641|NCT00414726|147715714|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon (Mann-Whitney)|We used the Van-Elteren extension of the Wilcoxon rank sum test; ajustments made for baseline NIHSS categories (4-11)(12-20)(\>20).||Subjects were analyzed using an intention to treat approach. All subjects were analyzed at 24 hours. For four subjects missing 24-hour NIHSS scores, the change score was given the highest possible value.||||0.91
74081642|NCT00414726|147715715|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Wilcoxon (Mann-Whitney)|We used the Van Elteren extension of the Wilcoxin rank sum test that adjusts for stratified randomization.||||||0.68
74081643|NCT01630616|147715747|SUPERIORITY_OR_OTHER||Ratio (Adolescents/adults)|0.89|||||TWO_SIDED|90.0|0.62|1.26||||||||1.26|0.62|
74081644|NCT01630616|147715748|SUPERIORITY_OR_OTHER||Ratio (Adolescents/Adults)|0.87|||||TWO_SIDED|90.0|0.62|1.23||||||||1.23|0.62|
74081645|NCT01630616|147715749|SUPERIORITY_OR_OTHER||Ratio (Adolescents/Adults)|0.81|||||TWO_SIDED|90.0|0.57|1.16||||||||1.16|0.57|
74081646|NCT02218541|147715752|OTHER|||||||1||||||threshold for significance will be p-value \<0.05|Fisher Exact|||||||1.00
74081647|NCT02218541|147715753|OTHER|||||||0.039||||||This statistical analysis applies to Yes bleeding|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change||||||0.039
74081648|NCT02218541|147715754|EQUIVALENCE|No power calculation was done as this was a pilot study.||||||1||||||This statistical analysis applies to Yes Provisional Crown fit|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change||||||1.0
74081649|NCT01993186|147715755|SUPERIORITY||Hodges-Lehmann estimate|13.45||||0.5812|TWO_SIDED|90.0|-38.63|80.95|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% confidence interval (CI) and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||80.95|-38.63|0.5812
74081650|NCT01993186|147715758|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.8197|TWO_SIDED|90.0|-51.23|84.25|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||84.25|-51.23|0.8197
74081651|NCT01993186|147715759|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.7276|TWO_SIDED|90.0|0.0|37.5|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||37.5|0|0.7276
74081652|NCT01993186|147715763|SUPERIORITY||Least squares mean difference|-2.384|STANDARD_ERROR_OF_MEAN|68.1231||0.486|TWO_SIDED|90.0|-114.44|109.67||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTISRTSD||109.67|-114.44|0.486
74081653|NCT01993186|147715763|SUPERIORITY||Least squares mean difference|63.669|STANDARD_ERROR_OF_MEAN|53.0537||0.8849|TWO_SIDED|90.0|-23.6|150.94||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDSRT||150.94|-23.6|0.8849
74081654|NCT01993186|147715763|SUPERIORITY||Least squares mean difference|-63.835|STANDARD_ERROR_OF_MEAN|60.6496||0.1463|TWO_SIDED|90.0|-163.59|35.93||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDFRT||35.93|-163.59|0.1463
74081655|NCT01993186|147715764|SUPERIORITY||Least squares mean difference|17.768|STANDARD_ERROR_OF_MEAN|11.5659||0.9378|TWO_SIDED|90.0|-1.26|36.79||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALTEA||36.79|-1.26|0.9378
74081656|NCT01993186|147715764|SUPERIORITY||Least squares mean difference|-0.531|STANDARD_ERROR_OF_MEAN|2.1853||0.5959|TWO_SIDED|90.0|-4.13|3.06||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALFTMS||3.06|-4.13|0.5959
73836854|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.76|1.06||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.06|0.76|
74081657|NCT01993186|147715765|SUPERIORITY||Least squares mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.4988||0.4522|TWO_SIDED|90.0|-0.76|0.88||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SSPSLF||0.88|-0.76|0.4522
74081658|NCT01993186|147715766|SUPERIORITY||LS Mean Difference|-1.237|STANDARD_ERROR_OF_MEAN|2.381||0.3017|TWO_SIDED|90.0|-5.15|2.68||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMBE48||2.68|-5.15|0.3017
74081659|NCT01993186|147715766|SUPERIORITY||Least squares mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.6495||0.5235|TWO_SIDED|90.0|-1.03|1.11||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMS68||1.11|-1.03|0.5235
74081660|NCT01993186|147715767|SUPERIORITY||Least squares mean difference|-6.897|STANDARD_ERROR_OF_MEAN|22.4806||0.6205|TWO_SIDED|90.0|-43.874|30.08||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled||30.08|-43.874|0.6205
74081661|NCT01993186|147715768|SUPERIORITY||Least squares mean difference|-1.354|STANDARD_ERROR_OF_MEAN|3.5759||0.6476|TWO_SIDED|90.0|-7.236|4.527||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled (percent predicted)||4.527|-7.236|0.6476
73836855|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|16.5|||||TWO_SIDED|95.0|3.56|76.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||76.14|3.56|
74081662|NCT01993186|147715770|SUPERIORITY||Least squares mean difference|1.568|STANDARD_ERROR_OF_MEAN|3.8899||0.3435|TWO_SIDED|90.0|-4.83|7.97||One-sided p-value. Additional model covariates include baseline GMFM-88 total score, visit and the interaction between visit and treatment.|GEE model|||GMFM-88 UX007-Placebo||7.97|-4.83|0.3435
74081663|NCT00385736|147715805|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared|||||||0.031
74081664|NCT00385736|147715805|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared|||||||0.833
74081665|NCT00385736|147715806|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.107
74081666|NCT00385736|147715807|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.382
74081667|NCT00385736|147715808|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.038
74081668|NCT00385736|147715809|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.035
74081669|NCT00385736|147715810|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.080
74081670|NCT00385736|147715811|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.264
74081671|NCT00385736|147715812|SUPERIORITY_OR_OTHER|||||||0.526||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.526
74081672|NCT00385736|147715813|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.506
74081673|NCT00385736|147715814|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.264
74081674|NCT00385736|147715815|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.797
74081675|NCT00385736|147715816|SUPERIORITY_OR_OTHER|||||||0.614||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.614
74081676|NCT00385736|147715817|SUPERIORITY_OR_OTHER|||||||0.532||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.532
74081677|NCT00835666|147715835|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|92.6|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|92.6|
74081678|NCT00835666|147715836|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.2||||||90.0|94.7|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.7|
74081679|NCT00835666|147715837|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.4||||||90.0|94.9|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.9|
74081680|NCT02312154|147715848|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
74081681|NCT02312154|147715849|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
74081682|NCT02312154|147715850|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
74081683|NCT02312154|147715851|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
74081684|NCT02312154|147715852|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.||||<0.05
74081685|NCT02312154|147715853|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.||||<0.05
74081686|NCT01634139|147715854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.108|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.231|0.108|<0.0001
74081687|NCT01634139|147715854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.164|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.103|0.255|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.255|0.103|<0.0001
74081688|NCT01634139|147715855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.036||0.0012|TWO_SIDED|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.186|0.046|0.0012
74081689|NCT01634139|147715855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.036||0.001|TWO_SIDED|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.188|0.048|0.0010
74081690|NCT01634139|147715855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.071|STANDARD_ERROR_OF_MEAN|0.036||0.0477|TWO_SIDED|95.0|0.001|0.142|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.142|0.001|0.0477
74081691|NCT01634139|147715855|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.099|STANDARD_ERROR_OF_MEAN|0.036||0.0059|TWO_SIDED|95.0|0.029|0.17|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.170|0.029|0.0059
74081692|NCT01634139|147715856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.124|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.062|0.185|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.185|0.062|<0.0001
74081693|NCT01634139|147715856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.065|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.188|0.065|<0.0001
74081694|NCT01634139|147715857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.095|0.212|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.212|0.095|<0.0001
74081695|NCT01634139|147715857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.157|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.098|0.215|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.215|0.098|<0.0001
74081696|NCT01634139|147715858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.036||0.0012|TWO_SIDED|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)||0.186|0.046|0.0012
74081697|NCT01634139|147715858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.036||0.001|TWO_SIDED|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose (Week 24)||0.188|0.048|0.0010
74081698|NCT01634139|147715858|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.076|0.201|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)||0.201|0.076|<0.0001
74081699|NCT01634139|147715858|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.151|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.088|0.213|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)||0.213|0.088|<0.0001
74081700|NCT01634139|147715858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.148|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.084|0.211|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (Week 24)||0.211|0.084|<0.0001
74081701|NCT01634139|147715858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.084|0.21|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (Week 24)||0.210|0.084|<0.0001
74081702|NCT01634139|147715858|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.163|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.101|0.226|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (Week 24)||0.226|0.101|<0.0001
74081703|NCT01634139|147715858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.106|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (Week 24)||0.231|0.106|<0.0001
74081704|NCT01634139|147715858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.116|0.24|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (Week 24)||0.240|0.116|<0.0001
74081705|NCT01634139|147715858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.176|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.114|0.238|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)||0.238|0.114|<0.0001
74081706|NCT01634139|147715859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.038||0.0036|TWO_SIDED|95.0|0.036|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.184|0.036|0.0036
74081707|NCT01634139|147715859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.091|STANDARD_ERROR_OF_MEAN|0.037||0.0152|TWO_SIDED|95.0|0.018|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.165|0.018|0.0152
74081708|NCT01634139|147715859|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.038||0.0687|TWO_SIDED|95.0|-0.005|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.143|-0.005|0.0687
74081709|NCT01634139|147715859|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.038||0.1666|TWO_SIDED|95.0|-0.022|0.126|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.126|-0.022|0.1666
74081710|NCT01634139|147715860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.04||0.0228|TWO_SIDED|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.171|0.013|0.0228
74081711|NCT01634139|147715860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.04||0.198|TWO_SIDED|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.131|-0.027|0.1980
74081712|NCT01634139|147715860|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.062|STANDARD_ERROR_OF_MEAN|0.04||0.1256|TWO_SIDED|95.0|-0.017|0.141|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.141|-0.017|0.1256
74081713|NCT01634139|147715860|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.053|STANDARD_ERROR_OF_MEAN|0.04||0.188|TWO_SIDED|95.0|-0.026|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.133|-0.026|0.1880
74081714|NCT01634139|147715861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.105|STANDARD_ERROR_OF_MEAN|0.034||0.0023|TWO_SIDED|95.0|0.037|0.172|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.172|0.037|0.0023
74081715|NCT01634139|147715861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.076|STANDARD_ERROR_OF_MEAN|0.034||0.0255|TWO_SIDED|95.0|0.009|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.143|0.009|0.0255
74081716|NCT01634139|147715862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.04||0.0228|TWO_SIDED|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)||0.171|0.013|0.0228
74081717|NCT01634139|147715862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.04||0.198|TWO_SIDED|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose.(Week 24)||0.131|-0.027|0.1980
74081718|NCT01634139|147715862|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.078|STANDARD_ERROR_OF_MEAN|0.037||0.0344|TWO_SIDED|95.0|0.006|0.15|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)||0.150|0.006|0.0344
74081719|NCT01634139|147715862|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.037||0.0696|TWO_SIDED|95.0|-0.005|0.139|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)||0.139|-0.005|0.0696
74081720|NCT01634139|147715862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.109|STANDARD_ERROR_OF_MEAN|0.037||0.0032|TWO_SIDED|95.0|0.037|0.182|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (week 24)||0.182|0.037|0.0032
74081721|NCT01634139|147715862|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.037||0.1044|TWO_SIDED|95.0|-0.012|0.132|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (week 24)||0.132|-0.012|0.1044
74081722|NCT01634139|147715862|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.113|STANDARD_ERROR_OF_MEAN|0.037||0.0027|TWO_SIDED|95.0|0.039|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (week 24)||0.186|0.039|0.0027
74081723|NCT01634139|147715862|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.093|STANDARD_ERROR_OF_MEAN|0.037||0.013|TWO_SIDED|95.0|0.02|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (week 24)||0.166|0.020|0.0130
74081724|NCT01634139|147715862|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.038||0.0025|TWO_SIDED|95.0|0.041|0.19|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (week 24)||0.190|0.041|0.0025
74081725|NCT01634139|147715862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.038||0.0156|TWO_SIDED|95.0|0.017|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)||0.166|0.017|0.0156
74081726|NCT01634139|147715863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.165|STANDARD_ERROR_OF_MEAN|0.11||0.1349|TWO_SIDED|95.0|-0.382|0.051|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.051|-0.382|0.1349
74081727|NCT01634139|147715863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.209|STANDARD_ERROR_OF_MEAN|0.11||0.0588|TWO_SIDED|95.0|-0.425|0.008|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.008|-0.425|0.0588
74081728|NCT01634139|147715863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.154|STANDARD_ERROR_OF_MEAN|0.111||0.1675|TWO_SIDED|95.0|-0.372|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.065|-0.372|0.1675
74081729|NCT01634139|147715863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.201|STANDARD_ERROR_OF_MEAN|0.111||0.0709|TWO_SIDED|95.0|-0.419|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.017|-0.419|0.0709
74081730|NCT01634139|147715864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.116|STANDARD_ERROR_OF_MEAN|0.065||0.0749|TWO_SIDED|95.0|-0.245|0.012|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.012|-0.245|0.0749
74081731|NCT01634139|147715864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.141|STANDARD_ERROR_OF_MEAN|0.065||0.0305|TWO_SIDED|95.0|-0.269|-0.013|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.013|-0.269|0.0305
74081732|NCT01634139|147715864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.125|STANDARD_ERROR_OF_MEAN|0.066||0.0581|TWO_SIDED|95.0|-0.255|0.004|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.004|-0.255|0.0581
74081733|NCT01634139|147715864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.131|STANDARD_ERROR_OF_MEAN|0.066||0.0464|TWO_SIDED|95.0|-0.26|-0.002|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||-0.002|-0.260|0.0464
74081734|NCT01634139|147715865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096|STANDARD_ERROR_OF_MEAN|0.062||0.1182|TWO_SIDED|95.0|-0.217|0.025|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.025|-0.217|0.1182
74081735|NCT01634139|147715865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.126|STANDARD_ERROR_OF_MEAN|0.061||0.0404|TWO_SIDED|95.0|-0.246|-0.006|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.006|-0.246|0.0404
74081736|NCT01634139|147715865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.099|STANDARD_ERROR_OF_MEAN|0.062||0.1105|TWO_SIDED|95.0|-0.221|0.023|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.023|-0.221|0.1105
74081737|NCT01634139|147715865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.103|STANDARD_ERROR_OF_MEAN|0.062||0.0983|TWO_SIDED|95.0|-0.224|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.019|-0.224|0.0983
74081738|NCT01634139|147715866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.507|STANDARD_ERROR_OF_MEAN|5.387||0.1146|TWO_SIDED|95.0|-2.063|19.077|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||19.077|-2.063|0.1146
74081739|NCT01634139|147715866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.493|STANDARD_ERROR_OF_MEAN|5.365||0.1628|TWO_SIDED|95.0|-3.034|18.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||18.020|-3.034|0.1628
74081740|NCT01634139|147715866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.538|STANDARD_ERROR_OF_MEAN|5.435||0.3085|TWO_SIDED|95.0|-5.127|16.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||16.203|-5.127|0.3085
74081741|NCT01634139|147715866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.774|STANDARD_ERROR_OF_MEAN|5.413||0.1053|TWO_SIDED|95.0|-1.847|19.394|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||19.394|-1.847|0.1053
74081742|NCT01634139|147715867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.36|STANDARD_ERROR_OF_MEAN|5.451||0.0236|TWO_SIDED|95.0|1.663|23.056|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||23.056|1.663|0.0236
74081743|NCT01634139|147715867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.146|STANDARD_ERROR_OF_MEAN|5.427||0.0093|TWO_SIDED|95.0|3.497|24.794|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||24.794|3.497|0.0093
74081744|NCT01634139|147715867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.882|STANDARD_ERROR_OF_MEAN|5.497||0.7322|TWO_SIDED|95.0|-12.667|8.904|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||8.904|-12.667|0.7322
74081745|NCT01634139|147715867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.176|STANDARD_ERROR_OF_MEAN|5.481||0.4463|TWO_SIDED|95.0|-6.578|14.929|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||14.929|-6.578|0.4463
74081746|NCT01634139|147715868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.262|STANDARD_ERROR_OF_MEAN|1.039||0.8008|TWO_SIDED|95.0|-1.775|2.299|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||2.299|-1.775|0.8008
74081747|NCT01634139|147715868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.166|STANDARD_ERROR_OF_MEAN|1.041||0.8731|TWO_SIDED|95.0|-1.875|2.208|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||2.208|-1.875|0.8731
74081748|NCT01634139|147715868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.272|STANDARD_ERROR_OF_MEAN|1.058||0.7975|TWO_SIDED|95.0|-1.803|2.346|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||2.346|-1.803|0.7975
74081749|NCT01634139|147715868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.579|STANDARD_ERROR_OF_MEAN|1.059||0.5845|TWO_SIDED|95.0|-2.656|1.498|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||1.498|-2.656|0.5845
74081750|NCT01634139|147715869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.048||0.6932|TWO_SIDED|95.0|-0.075|0.113|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.113|-0.075|0.6932
74081751|NCT01634139|147715869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.048||0.1741|TWO_SIDED|95.0|-0.158|0.029|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.029|-0.158|0.1741
74081752|NCT01634139|147715869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.024|STANDARD_ERROR_OF_MEAN|0.048||0.625|TWO_SIDED|95.0|-0.071|0.118|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.118|-0.071|0.6250
74081753|NCT01634139|147715869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.048||0.7597|TWO_SIDED|95.0|-0.109|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.080|-0.109|0.7597
74081754|NCT01634139|147715870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.05||0.6166|TWO_SIDED|95.0|-0.122|0.073|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.073|-0.122|0.6166
74081755|NCT01634139|147715870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.076|STANDARD_ERROR_OF_MEAN|0.049||0.1267|TWO_SIDED|95.0|-0.173|0.021|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.021|-0.173|0.1267
74081756|NCT01634139|147715870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.05||0.9|TWO_SIDED|95.0|-0.092|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.105|-0.092|0.9000
74081757|NCT01634139|147715870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.05||0.3897|TWO_SIDED|95.0|-0.141|0.055|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.055|-0.141|0.3897
74081758|NCT01634139|147715871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.072||0.0975|TWO_SIDED|95.0|-0.262|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.022|-0.262|0.0975
74081759|NCT01634139|147715871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.182|STANDARD_ERROR_OF_MEAN|0.072||0.0116|TWO_SIDED|95.0|-0.323|-0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.041|-0.323|0.0116
74081760|NCT01634139|147715871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.073||0.3732|TWO_SIDED|95.0|-0.208|0.078|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.078|-0.208|0.3732
74081761|NCT01634139|147715871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093|STANDARD_ERROR_OF_MEAN|0.073||0.1985|TWO_SIDED|95.0|-0.236|0.049|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.049|-0.236|0.1985
74081762|NCT01634139|147715873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.176|STANDARD_ERROR_OF_MEAN|0.072||0.0144|TWO_SIDED|95.0|0.035|0.316|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.316|0.035|0.0144
74081763|NCT01634139|147715873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.071||0.0747|TWO_SIDED|95.0|-0.013|0.267|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.267|-0.013|0.0747
74081764|NCT01634139|147715873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021|STANDARD_ERROR_OF_MEAN|0.072||0.7654|TWO_SIDED|95.0|-0.163|0.12|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.120|-0.163|0.7654
74081765|NCT01634139|147715873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.072||0.8082|TWO_SIDED|95.0|-0.124|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.158|-0.124|0.8082
74081766|NCT01634139|147715874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.175|STANDARD_ERROR_OF_MEAN|0.085||0.0392|TWO_SIDED|95.0|0.009|0.341|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.341|0.009|0.0392
74081767|NCT01634139|147715874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.084||0.1351|TWO_SIDED|95.0|-0.039|0.292|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.292|-0.039|0.1351
74081768|NCT01634139|147715874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.085||0.8291|TWO_SIDED|95.0|-0.185|0.149|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.149|-0.185|0.8291
74081769|NCT01634139|147715874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.085||0.9655|TWO_SIDED|95.0|-0.163|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.171|-0.163|0.9655
74081770|NCT01634139|147715875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.191|STANDARD_ERROR_OF_MEAN|0.077||0.0139|TWO_SIDED|95.0|0.039|0.343|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.343|0.039|0.0139
74081771|NCT01634139|147715875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.077||0.1043|TWO_SIDED|95.0|-0.026|0.276|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.276|-0.026|0.1043
74081772|NCT01634139|147715875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.078||0.6547|TWO_SIDED|95.0|-0.118|0.187|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.187|-0.118|0.6547
74081773|NCT01634139|147715875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.077||0.3648|TWO_SIDED|95.0|-0.082|0.222|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.222|-0.082|0.3648
74081774|NCT01634139|147715876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.166|STANDARD_ERROR_OF_MEAN|0.074||0.0256|TWO_SIDED|95.0|0.02|0.312|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.312|0.020|0.0256
74081775|NCT01634139|147715876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.141|STANDARD_ERROR_OF_MEAN|0.074||0.0561|TWO_SIDED|95.0|-0.004|0.286|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.286|-0.004|0.0561
74081776|NCT01634139|147715876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.061|STANDARD_ERROR_OF_MEAN|0.075||0.4127|TWO_SIDED|95.0|-0.208|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.085|-0.208|0.4127
74081777|NCT01634139|147715876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.074||0.8922|TWO_SIDED|95.0|-0.136|0.156|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.156|-0.136|0.8922
74081778|NCT01634139|147715878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.036||0.7931|TWO_SIDED|95.0|-0.08|0.061|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.061|-0.080|0.7931
74081779|NCT01634139|147715878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.036||0.0369|TWO_SIDED|95.0|-0.145|-0.005|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.005|-0.145|0.0369
74081780|NCT01634139|147715878|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.036||0.4086|TWO_SIDED|95.0|-0.101|0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.041|-0.101|0.4086
74081781|NCT01634139|147715878|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.026|STANDARD_ERROR_OF_MEAN|0.036||0.4714|TWO_SIDED|95.0|-0.097|0.045|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.045|-0.097|0.4714
74081782|NCT01634139|147715879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.001|STANDARD_ERROR_OF_MEAN|0.047||0.988|TWO_SIDED|95.0|-0.091|0.092|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.092|-0.091|0.9880
74081783|NCT01634139|147715879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.082|STANDARD_ERROR_OF_MEAN|0.046||0.0794|TWO_SIDED|95.0|-0.173|0.01|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.010|-0.173|0.0794
74081784|NCT01634139|147715879|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.053|STANDARD_ERROR_OF_MEAN|0.047||0.2623|TWO_SIDED|95.0|-0.145|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.040|-0.145|0.2623
74081785|NCT01634139|147715879|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.047||0.3552|TWO_SIDED|95.0|-0.136|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.040|-0.136|0.3552
74081786|NCT01634139|147715880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.039|STANDARD_ERROR_OF_MEAN|0.049||0.4359|TWO_SIDED|95.0|-0.135|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.058|-0.135|0.4359
74081787|NCT01634139|147715880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.059|STANDARD_ERROR_OF_MEAN|0.049||0.2293|TWO_SIDED|95.0|-0.155|0.037|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.037|-0.155|0.2293
74081788|NCT01634139|147715880|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8372|TWO_SIDED|95.0|-0.108|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.088|-0.108|0.8372
74081789|NCT01634139|147715880|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.051|STANDARD_ERROR_OF_MEAN|0.049||0.3022|TWO_SIDED|95.0|-0.148|0.046|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.046|-0.148|0.3022
74081790|NCT01634139|147715881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.031|STANDARD_ERROR_OF_MEAN|0.046||0.5004|TWO_SIDED|95.0|-0.122|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.060|-0.122|0.5004
74081791|NCT01634139|147715881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.059|STANDARD_ERROR_OF_MEAN|0.046||0.1982|TWO_SIDED|95.0|-0.149|0.031|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.031|-0.149|0.1982
74081792|NCT01634139|147715881|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.047||0.8019|TWO_SIDED|95.0|-0.103|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.080|-0.103|0.8019
74081793|NCT01634139|147715881|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.032|STANDARD_ERROR_OF_MEAN|0.046||0.4872|TWO_SIDED|95.0|-0.123|0.059|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.059|-0.123|0.4872
74081794|NCT01634139|147715882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.046||0.3498|TWO_SIDED|95.0|-0.135|0.048|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.048|-0.135|0.3498
74081795|NCT01634139|147715882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.106|STANDARD_ERROR_OF_MEAN|0.046||0.0222|TWO_SIDED|95.0|-0.196|-0.015|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.015|-0.196|0.0222
74081796|NCT01634139|147715882|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.047||0.799|TWO_SIDED|95.0|-0.104|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.080|-0.104|0.7990
74081797|NCT01634139|147715882|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.035|STANDARD_ERROR_OF_MEAN|0.047||0.4586|TWO_SIDED|95.0|-0.126|0.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.057|-0.126|0.4586
74081798|NCT01634139|147715883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.056||0.4221|TWO_SIDED|95.0|-0.156|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.065|-0.156|0.4221
74081799|NCT01634139|147715883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093|STANDARD_ERROR_OF_MEAN|0.056||0.0959|TWO_SIDED|95.0|-0.204|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.017|-0.204|0.0959
74081800|NCT01634139|147715883|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.057||0.9627|TWO_SIDED|95.0|-0.109|0.114|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.114|-0.109|0.9627
74081801|NCT01634139|147715883|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.054|STANDARD_ERROR_OF_MEAN|0.057||0.3457|TWO_SIDED|95.0|-0.165|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.058|-0.165|0.3457
74081802|NCT01634139|147715884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.041|STANDARD_ERROR_OF_MEAN|0.043||0.3375|TWO_SIDED|95.0|-0.043|0.125|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.125|-0.043|0.3375
74081803|NCT01634139|147715884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.043||0.388|TWO_SIDED|95.0|-0.047|0.121|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.121|-0.047|0.3880
74081804|NCT01634139|147715884|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.043||0.6541|TWO_SIDED|95.0|-0.066|0.104|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.104|-0.066|0.6541
74081805|NCT01634139|147715884|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.028|STANDARD_ERROR_OF_MEAN|0.043||0.5089|TWO_SIDED|95.0|-0.056|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.133|-0.056|0.5089
74081806|NCT04442503|147715914|SUPERIORITY||Least Square Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.16||0.0007|TWO_SIDED|95.0|-6.3|-1.7|||MMRM|||Change from Baseline at Day 15||-1.7|-6.3|0.0007
74081807|NCT04442503|147715915|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.999||0.0008|TWO_SIDED|95.0|-5.4|-1.4|||MMRM|||Change from Baseline at Day 3||-1.4|-5.4|0.0008
74081808|NCT04442503|147715915|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.244||0.0203|TWO_SIDED|95.0|-5.4|-0.5|||MMRM|||Change from Baseline at Day 28||-0.5|-5.4|0.0203
74081809|NCT04442503|147715915|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.277||0.0067|TWO_SIDED|95.0|-6.0|-1.0|||MMRM|||Change from Baseline at Day 45||-1.0|-6.0|0.0067
74081810|NCT04442503|147715916|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.196||0.0052|TWO_SIDED|95.0|-0.9|-0.2|||MMRM|||Change from Baseline at Day 15||-0.2|-0.9|0.0052
74081811|NCT04442503|147715917|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0209|TWO_SIDED|95.0|1.112|3.67||P-value are from a generalized estimating equation (GEE) for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 15||3.670|1.112|0.0209
74081812|NCT04442503|147715917|SUPERIORITY||Odds Ratio (OR)|1.534||||0.1661|TWO_SIDED|95.0|0.837|2.812||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 45||2.812|0.837|0.1661
74081813|NCT04442503|147715918|SUPERIORITY||Odds Ratio (OR)|1.781||||0.111|TWO_SIDED|95.0|0.876|3.621||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 15||3.621|0.876|0.1110
74081814|NCT04442503|147715918|SUPERIORITY||Odds Ratio (OR)|2.083||||0.0226|TWO_SIDED|95.0|1.108|3.915||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 45||3.915|1.108|0.0226
74081815|NCT04442503|147715919|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0089|TWO_SIDED|95.0|1.223|4.072|||MMRM|||Day 15||4.072|1.223|0.0089
74081816|NCT04442503|147715920|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.98||0.0235|TWO_SIDED|95.0|-4.2|-0.3|||MMRM|||Change from Baseline at Day 15||-0.3|-4.2|0.0235
74081817|NCT04442503|147715921|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.706||0.0034|TWO_SIDED|95.0|-8.4|-1.7|||MMRM|||Change from Baseline at Day 15||-1.7|-8.4|0.0034
74081818|NCT04442503|147715922|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.4||0.0151|TWO_SIDED|95.0|-10.6|-1.2|||MMRM|||Change from Baseline in Core Subscale at Day 15||-1.2|-10.6|0.0151
74081819|NCT04442503|147715922|SUPERIORITY||LS Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|2.27||0.0123|TWO_SIDED|95.0|-10.2|-1.3|||MMRM|||Change from Baseline in Anxiety Subscale at Day 15||-1.3|-10.2|0.0123
74081820|NCT04442503|147715922|SUPERIORITY||LS Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|2.96||0.004|TWO_SIDED|95.0|-14.5|-2.8|||MMRM|||Change from Baseline in Bech-6 Subscale at Day 15||-2.8|-14.5|0.0040
74081821|NCT04442503|147715922|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|2.609||0.0041|TWO_SIDED|95.0|-12.7|-2.4|||MMRM|||Change from Baseline in Meier Subscale at Day 15||-2.4|-12.7|0.0041
74081822|NCT04442503|147715924|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.649||0.6912|TWO_SIDED|95.0|-1.0|1.5|||MMRM|||Change from Baseline at Day 3||1.5|-1.0|0.6912
74081823|NCT04442503|147715924|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.874||0.041|TWO_SIDED|95.0|-3.5|-0.1|||MMRM|||Change from Baseline at Day 8||-0.1|-3.5|0.0410
74081824|NCT04442503|147715924|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.922||0.0444|TWO_SIDED|95.0|-3.7|0.0|||MMRM|||Change from Baseline at Day 15||0.0|-3.7|0.0444
74081825|NCT04442503|147715924|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.924||0.0811|TWO_SIDED|95.0|-3.4|0.2|||MMRM|||Change from Baseline at Day 21||0.2|-3.4|0.0811
74081826|NCT04442503|147715924|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.987||0.1846|TWO_SIDED|95.0|-3.3|0.6|||MMRM|||Change from Baseline at Day 28||0.6|-3.3|0.1846
74081827|NCT04442503|147715924|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.031||0.0625|TWO_SIDED|95.0|-4.0|0.1|||MMRM|||Change from Baseline at Day 45||0.1|-4.0|0.0625
74081828|NCT00989950|147715936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|14.0||0.588|TWO_SIDED|95.0|0.0|233.0|||ANOVA|||||233|0|0.588
74081829|NCT00101439|147715937|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|0.89||||0.241|TWO_SIDED|95.0|0.73|1.08||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo|||1.08|0.73|0.241
74081830|NCT00101439|147715938|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|1.02||||0.812|TWO_SIDED|95.0|0.87|1.2||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo|||1.20|0.87|0.812
74081831|NCT00474058|147715943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.55||||0.0002||95.0|-5.37|-1.73||No p-value adjustment was necessary, since a multiple test procedure in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-1.73|-5.37|0.0002
74081832|NCT00474058|147715944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26|||<|0.0001||95.0|-6.08|-2.45||No p-value adjustment was necessary, since a multiple testing in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-2.45|-6.08|<0.0001
74081833|NCT00474058|147715945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0301||95.0|-0.79|-0.04|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-0.04|-0.79|0.0301
74081834|NCT00474058|147715946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8842||95.0|-0.29|0.25|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||0.25|-0.29|0.8842
74081835|NCT02426918|147715947|NON_INFERIORITY|Non-inferiority for the low dose was confirmed if the upper bound of the CI was \< 15% and if non-inferiority was confirmed for the high dose.|Risk Difference (RD)|-4.2|||||TWO_SIDED|95.0|-11.42|3.0||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \[cellulitis, noncellulitis\] according to a Mantel-Haenszel type risk difference estimator.||3.00|-11.42|
74081836|NCT02426918|147715947|NON_INFERIORITY|Non-inferiority for the high dose was confirmed if the upper bound of the CI was \< 15%.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-8.32|8.38||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \[cellulitis, noncellulitis\] according to a Mantel-Haenszel type risk difference estimator.||8.38|-8.32|
74081837|NCT03306277|147715973|SUPERIORITY||||||<|0.0001|||||||One-sided Exact Binomial Test|||This comparison is made to an assumed rate of zero 0 (or as low as 0.1%). By definition, children with spinal muscular atrophy Type 1 are never able to sit independently.||||<0.0001
74081838|NCT03306277|147715974|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||This comparison is made against the results from the age and gender-matched control participants selected from existing natural history data sets (PNCR) \[Neurol. 2014; 83(9):810-817\].|Data for the current study were compared to historical control data (Finkel et al,2014 - PubMed 25080519) where event-free survival was 6 out of 23 participants (26.1%) at 14 months of age.|||<0.0001
74081839|NCT00380588|147716008|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||P-value for response (Complete Response + Partial Response).|Fisher Exact|||||||0.380
74081840|NCT00380588|147716009|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Log Rank|||||||0.074
74081841|NCT00380588|147716010|SUPERIORITY_OR_OTHER|||||||0.136||95.0|||||Log Rank|||||||0.136
74081842|NCT01120028|147716024|OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.64|||Log Rank|||||0.64|0.28|<0.0001
74081843|NCT01120028|147716025|OTHER|||||||0.5|||||||ANCOVA|||||||0.5
74081844|NCT01120028|147716026|OTHER||Hazard Ratio (HR)|1.23||||0.58|TWO_SIDED|95.0|0.59|2.55|||Regression, Cox|||||2.55|0.59|0.58
74081845|NCT01120028|147716027|OTHER||Rate Ratio|1.99||||0.23|TWO_SIDED|95.0|0.64|6.18|||Log Rank|||||6.18|0.64|0.23
74081846|NCT01120028|147716028|OTHER||Rate Ratio|1.02||||0.88|TWO_SIDED|95.0|0.8|1.29|||Regression, Cox|||||1.29|0.80|0.88
74081847|NCT01120028|147716029|OTHER||Rate ratio|1.51||||0.008|TWO_SIDED|95.0|1.11|2.06|||Log Rank|||||2.06|1.11|0.008
74081848|NCT01120028|147716030|OTHER||Rate Ratio|1.0||||0.99|TWO_SIDED|95.0|0.51|1.97|||Log Rank|||||1.97|0.51|0.99
74081849|NCT01120028|147716031|OTHER||Rate Ratio|0.76||||0.52|TWO_SIDED|95.0|0.34|1.73|||Log Rank|||||1.73|0.34|0.52
74081850|NCT01131260|147716035|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.31||||0.2|TWO_SIDED|95.0|0.87|1.98|||Chi-squared|||Analysis on primary composite outcome as a whole.||1.98|0.87|0.20
74081851|NCT01131260|147716037|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.02||||0.37|TWO_SIDED|95.0|0.31|29.1|||Fisher Exact|||||29.1|0.31|0.37
74081852|NCT01131260|147716038|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.86||||0.02|TWO_SIDED|95.0|1.13|7.24|||Chi-squared|||||7.24|1.13|0.02
74081853|NCT01131260|147716039|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76||||1|TWO_SIDED|95.0|0.17|3.38|||Fisher Exact|||||3.38|0.17|1.0
74081854|NCT01131260|147716040|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.13|TWO_SIDED|95.0|0.1|1.41|||Chi-squared|||||1.41|0.10|0.13
74081855|NCT01131260|147716041|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.57||||0.07|TWO_SIDED|95.0|0.97|2.54|||Chi-squared|||||2.54|0.97|0.07
74081856|NCT01131260|147716042|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||1|TWO_SIDED|95.0|0.22|3.0|||Fisher Exact|||||3.00|0.22|1.0
74081857|NCT01131260|147716043|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||.17
74081858|NCT01131260|147716044|SUPERIORITY_OR_OTHER|||||||0.45||||||The p value was calculated based on the entire study cohort.|Chi-squared|||||||0.45
74081859|NCT01131260|147716046|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||.32
74081860|NCT01131260|147716047|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
74081861|NCT01131260|147716048|SUPERIORITY_OR_OTHER|||||||0.4|||||||Chi-squared|||||||0.40
74081862|NCT01131260|147716049|SUPERIORITY_OR_OTHER|||||||0.59|||||||Chi-squared|||||||0.59
74081863|NCT01131260|147716050|SUPERIORITY_OR_OTHER|||||||0.19|||||||Chi-squared|||||||.19
74081864|NCT01131260|147716051|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
74081865|NCT01131260|147716052|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||||||0.28
74081866|NCT01131260|147716053|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
74081867|NCT01131260|147716054|SUPERIORITY_OR_OTHER|||||||0.98|||||||Chi-squared|||||||0.98
74081868|NCT01131260|147716055|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||.05
74081869|NCT03544216|147716056|OTHER||||||<|0.001||||||"Results of post-hoc analyses comparing scores of each lens type to one another:~Habitual lens and multifocal contact lens: p \<0.001 Habitual lens and single vision lens: p \<0.001 Multifocal lens and single vision lens: p = 0.08"|Generalized linear models|||Generalized linear models (controlling for repeated measures) of crossover analyses was run to compare mean CLDEQ-8 scores with habitual, multifocal, and single vision contact lenses (controlling for order)||||<0.001
74081870|NCT03544216|147716056|OTHER|||||||0.5||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and refractive error (continuous, mean binocular spherical equivalent)||||0.5
74081871|NCT03544216|147716056|OTHER|||||||0.7||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between magnitude in accommodative lag (measured in diopters with a 2 diopter visual target) and lens type (single vision or multifocal)||||0.7
74081872|NCT03544216|147716056|OTHER|||||||0.3||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (continuous, measured in self-reported years)||||0.3
74081873|NCT03544216|147716056|OTHER|||||||0.047||||||Analysis controlled for order, visit, and repeated measures|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (measured categorically as 30 to \<35 years old and 35 to 40 years old, by self report)|"Post-Hoc Testing comparing CLDEQ-8 scores and the interaction between lens type and age group (denoted by lens type\*age group) produced the following results:~p = 0.01 for MF\*\<35 age group compared to Single Vision (SV)\*\<35 age group p = 0.07 for MF\*\<35 age group compared to MF\*\>35 age group p \> 0.05 for MF\*\<35 age group compared to Single Vision (SV)\*\>35 age group p \> 0.05 for SV\*\<35 age group compared to SV\*\>35 age group p \>0.05 for SV\*\<35 age group compared to MF\*\>35 age group p \> 0.05 for MF\*\>35 age group compared to SV\*\>25 age group"|||0.047
74081874|NCT02153645|147716057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.9||0.179|TWO_SIDED|95.0|-13.9|2.6|||ANCOVA|||||2.6|-13.9|0.179
74081875|NCT02153645|147716057|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.95||0.458|TWO_SIDED|95.0|-11.2|5.1|||ANCOVA|||||5.1|-11.2|0.458
74081876|NCT02583048|147716091|SUPERIORITY||Mean Difference (Net)|8.4|||||TWO_SIDED|95.1|2.0|14.8|||||Arm 3 minus Arm 1 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.|||14.8|2.0|
74081877|NCT02583048|147716091|SUPERIORITY||Mean Difference (Net)|12.1|||||TWO_SIDED|95.1|5.7|18.6|||||Arm 3 minus Arm 2 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.|||18.6|5.7|
74081878|NCT02583048|147716098|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.117|||||TWO_SIDED|90.0|0.884|1.411|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.411|0.884|
74081879|NCT02583048|147716098|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.202|||||TWO_SIDED|90.0|0.989|1.461|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.461|0.989|
74081880|NCT02583048|147716098|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.958|||||TWO_SIDED|90.0|0.774|1.187|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.187|0.774|
74081881|NCT02583048|147716099|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.986|||||TWO_SIDED|90.0|0.801|1.215|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.215|0.801|
74081882|NCT02583048|147716099|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.978|||||TWO_SIDED|90.0|0.764|1.251|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.251|0.764|
74081883|NCT02583048|147716099|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.859|||||TWO_SIDED|90.0|0.667|1.108|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.108|0.667|
74081884|NCT02583048|147716100|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.036|||||TWO_SIDED|90.0|0.847|1.267|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.267|0.847|
74081885|NCT02583048|147716100|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.037|||||TWO_SIDED|90.0|0.843|1.276|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.276|0.843|
74081886|NCT02583048|147716100|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.915|||||TWO_SIDED|90.0|0.727|1.151|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.151|0.727|
74081887|NCT02583048|147716101|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.043|||||TWO_SIDED|90.0|0.864|1.258|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.258|0.864|
74081888|NCT02583048|147716101|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.029|||||TWO_SIDED|90.0|0.858|1.235|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.235|0.858|
74081889|NCT02583048|147716101|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.808|||||TWO_SIDED|90.0|0.657|0.993|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||0.993|0.657|
74081890|NCT02583048|147716102|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.068|||||TWO_SIDED|90.0|0.903|1.263|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.263|0.903|
74081891|NCT02583048|147716102|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.973|||||TWO_SIDED|90.0|0.82|1.155|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.155|0.820|
74081892|NCT02583048|147716102|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.803|||||TWO_SIDED|90.0|0.656|0.983|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||0.983|0.656|
73898279|NCT02880956|147328884|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898280|NCT02880956|147328884|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.567|TWO_SIDED|95.0|-0.282|0.155||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.155|-0.282|0.567
73898281|NCT02880956|147328884|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898282|NCT02880956|147328885|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.099||0.931|TWO_SIDED|95.0|-0.204|0.187||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.187|-0.204|0.931
73898283|NCT02880956|147328885|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898284|NCT02880956|147328885|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.097||0.187|TWO_SIDED|95.0|-0.32|0.063||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.063|-0.320|0.187
73898285|NCT02880956|147328885|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898286|NCT02880956|147328885|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.961|TWO_SIDED|95.0|-0.191|0.201||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.201|-0.191|0.961
73898287|NCT02880956|147328885|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
74081893|NCT02583048|147716103|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.049|||||TWO_SIDED|90.0|0.881|1.248|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.248|0.881|
74081894|NCT02583048|147716103|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.979|||||TWO_SIDED|90.0|0.823|1.165|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.165|0.823|
74081895|NCT02583048|147716103|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.808|||||TWO_SIDED|90.0|0.638|1.025|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.025|0.638|
74081896|NCT02583048|147716104|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.903|||||TWO_SIDED|90.0|0.778|1.049|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.049|0.778|
74081897|NCT02583048|147716104|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.114|||||TWO_SIDED|90.0|0.944|1.315|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.315|0.944|
74081898|NCT02583048|147716104|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.804|||||TWO_SIDED|90.0|0.639|1.012|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.012|0.639|
74081899|NCT02583048|147716105|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.937|||||TWO_SIDED|90.0|0.81|1.084|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.084|0.810|
74081900|NCT02583048|147716105|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.107|||||TWO_SIDED|90.0|0.929|1.318|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.318|0.929|
74081901|NCT02583048|147716105|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.856|||||TWO_SIDED|90.0|0.703|1.043|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.043|0.703|
74081902|NCT02583048|147716106|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.951|||||TWO_SIDED|90.0|0.825|1.096|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.096|0.825|
74081903|NCT02583048|147716106|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.136|||||TWO_SIDED|90.0|0.948|1.362|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.362|0.948|
74081904|NCT02583048|147716106|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.898|||||TWO_SIDED|90.0|0.727|1.109|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.109|0.727|
74081905|NCT02583048|147716107|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.939|||||TWO_SIDED|90.0|0.806|1.094|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.094|0.806|
74081906|NCT02583048|147716107|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.081|||||TWO_SIDED|90.0|0.864|1.352|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.352|0.864|
74081907|NCT02583048|147716107|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.865|||||TWO_SIDED|90.0|0.597|1.253|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.253|0.597|
74081908|NCT02583048|147716108|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.825|1.095|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.095|0.825|
74081909|NCT02583048|147716108|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.862|1.354|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.354|0.862|
74081910|NCT02583048|147716108|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.865|||||TWO_SIDED|90.0|0.605|1.239|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.239|0.605|
74081911|NCT02583048|147716109|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.984|||||TWO_SIDED|90.0|0.851|1.138|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.138|0.851|
74081912|NCT02583048|147716109|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.086|||||TWO_SIDED|90.0|0.866|1.361|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.361|0.866|
74081913|NCT02583048|147716109|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.927|||||TWO_SIDED|90.0|0.65|1.322|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.322|0.650|
74081914|NCT02155257|147716113|OTHER||Slope|0.19||||0.54|TWO_SIDED|95.0|-0.39|0.76|||Regression, Linear|||Interaction between resting pupil diameter and correlation of cognitive-affective style to pain reporting. Note that this analysis is an INTERACTION between the primary outcome of this measure (pupil diameter) to that of the primary outcome measure of cognitive-affective style.||.76|-.39|0.540
74081915|NCT01851876|147716117|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Fisher Exact|||||||0.025
74081916|NCT01243151|147716139|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-54.68|STANDARD_ERROR_OF_MEAN|8.323|<|0.0001|TWO_SIDED|95.0|-71.37|-37.99|||ANCOVA|||Day 8: Analysis was performed using the analysis of covariance (ANCOVA) treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.99|-71.37|<0.0001
74081917|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.18|STANDARD_ERROR_OF_MEAN|8.53|<|0.0001|TWO_SIDED|95.0|-61.28|-27.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.08|-61.28|<0.0001
74081918|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.44|STANDARD_ERROR_OF_MEAN|8.433|<|0.0001|TWO_SIDED|95.0|-81.35|-47.53|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.53|-81.35|<0.0001
74081919|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.75|STANDARD_ERROR_OF_MEAN|8.282|<|0.0001|TWO_SIDED|95.0|-78.36|-45.15|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.15|-78.36|<0.0001
74081920|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-72.16|STANDARD_ERROR_OF_MEAN|10.097|<|0.0001|TWO_SIDED|95.0|-92.4|-51.92|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-51.92|-92.40|<0.0001
74081921|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.89|STANDARD_ERROR_OF_MEAN|10.328|<|0.0001|TWO_SIDED|95.0|-84.59|-43.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.19|-84.59|<0.0001
74081922|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-88.69|STANDARD_ERROR_OF_MEAN|10.327|<|0.0001|TWO_SIDED|95.0|-109.39|-68.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-68.00|-109.39|<0.0001
74081923|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.65|STANDARD_ERROR_OF_MEAN|10.028|<|0.0001|TWO_SIDED|95.0|-104.76|-64.54|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-64.54|-104.76|<0.0001
74081924|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.47|STANDARD_ERROR_OF_MEAN|8.854|<|0.0001|TWO_SIDED|95.0|-96.22|-60.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-60.71|-96.22|<0.0001
74081925|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.45|STANDARD_ERROR_OF_MEAN|8.998|<|0.0001|TWO_SIDED|95.0|-102.51|-66.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.40|-102.51|<0.0001
74081926|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-96.08|STANDARD_ERROR_OF_MEAN|8.994|<|0.0001|TWO_SIDED|95.0|-114.12|-78.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-78.03|-114.12|<0.0001
74081927|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-92.33|STANDARD_ERROR_OF_MEAN|8.703|<|0.0001|TWO_SIDED|95.0|-109.8|-74.86|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.86|-109.80|<0.0001
74081928|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.41|STANDARD_ERROR_OF_MEAN|9.534|<|0.0001|TWO_SIDED|95.0|-90.51|-52.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.30|-90.51|<0.0001
74081929|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.01|STANDARD_ERROR_OF_MEAN|9.659|<|0.0001|TWO_SIDED|95.0|-95.37|-56.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-56.65|-95.37|<0.0001
74081930|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.78|STANDARD_ERROR_OF_MEAN|9.678|<|0.0001|TWO_SIDED|95.0|-113.18|-74.38|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.38|-113.18|<0.0001
74081931|NCT01243151|147716139|SUPERIORITY_OR_OTHER||LS Mean Difference|-89.58|STANDARD_ERROR_OF_MEAN|9.362|<|0.0001|TWO_SIDED|95.0|-108.35|-70.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-70.81|-108.35|<0.0001
74081932|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.82|STANDARD_ERROR_OF_MEAN|5.077|<|0.0001|TWO_SIDED|95.0|-43.99|-23.65|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.65|-43.99|<0.0001
74081933|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.93|STANDARD_ERROR_OF_MEAN|5.202|<|0.0001|TWO_SIDED|95.0|-38.35|-17.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-17.51|-38.35|<0.0001
74081934|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.59|STANDARD_ERROR_OF_MEAN|5.143|<|0.0001|TWO_SIDED|95.0|-49.89|-29.28|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.28|-49.89|<0.0001
74081935|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.63|STANDARD_ERROR_OF_MEAN|5.051|<|0.0001|TWO_SIDED|95.0|-47.75|-27.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.51|-47.75|<0.0001
74081936|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.99|STANDARD_ERROR_OF_MEAN|6.384|<|0.0001|TWO_SIDED|95.0|-58.78|-33.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-33.20|-58.78|<0.0001
74081937|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.82|STANDARD_ERROR_OF_MEAN|6.527|<|0.0001|TWO_SIDED|95.0|-54.9|-28.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-28.74|-54.90|<0.0001
74081938|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.35|STANDARD_ERROR_OF_MEAN|6.531|<|0.0001|TWO_SIDED|95.0|-69.43|-43.27|||ANCOVA|||Day 15: Analysis was performed using ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.27|-69.43|<0.0001
74081939|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.45|STANDARD_ERROR_OF_MEAN|6.344|<|0.0001|TWO_SIDED|95.0|-66.17|-40.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-40.74|-66.17|<0.0001
74081940|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.67|STANDARD_ERROR_OF_MEAN|5.498|<|0.0001|TWO_SIDED|95.0|-60.7|-38.64|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.64|-60.70|<0.0001
74081941|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.92|STANDARD_ERROR_OF_MEAN|5.592|<|0.0001|TWO_SIDED|95.0|-65.14|-42.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-42.70|-65.14|<0.0001
74081942|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.6|STANDARD_ERROR_OF_MEAN|5.59|<|0.0001|TWO_SIDED|95.0|-71.81|-49.38|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.38|-71.81|<0.0001
74081943|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.67|STANDARD_ERROR_OF_MEAN|5.413|<|0.0001|TWO_SIDED|95.0|-68.53|-46.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-46.80|-68.53|<0.0001
74081944|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.18|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|95.0|-55.8|-32.57|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.57|-55.80|<0.0001
74081945|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.28|STANDARD_ERROR_OF_MEAN|5.881|<|0.0001|TWO_SIDED|95.0|-59.06|-35.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-35.50|-59.06|<0.0001
74081946|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.73|STANDARD_ERROR_OF_MEAN|5.891|<|0.0001|TWO_SIDED|95.0|-69.53|-45.94|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.94|-69.53|<0.0001
74081947|NCT01243151|147716140|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.96|STANDARD_ERROR_OF_MEAN|5.701|<|0.0001|TWO_SIDED|95.0|-66.38|-43.54|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.54|-66.38|<0.0001
74081948|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.972||||0.0472|TWO_SIDED|95.0|1.04|599.65|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||599.65|1.04|0.0472
74081949|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.815||||0.1368|TWO_SIDED|95.0|0.46|305.54|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||305.54|0.46|0.1368
74081950|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.527||||0.019|TWO_SIDED|95.0|1.89|1198.29|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1198.29|1.89|0.0190
74081951|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|45.328||||0.0192|TWO_SIDED|95.0|1.86|1103.73|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1103.73|1.86|0.0192
74081952|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|74.273||||0.0105|TWO_SIDED|95.0|2.74|2014.67|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2014.67|2.74|0.0105
74081953|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|86.088||||0.0086|TWO_SIDED|95.0|3.1|2389.27|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2389.27|3.10|0.0086
74081954|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|87.733||||0.0084|TWO_SIDED|95.0|3.14|2449.11|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2449.11|3.14|0.0084
73898288|NCT02880956|147328885|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.124||0.894|TWO_SIDED|95.0|-0.26|0.227||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.227|-0.260|0.894
73898289|NCT02880956|147328885|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898290|NCT02880956|147328885|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.121||0.917|TWO_SIDED|95.0|-0.226|0.251||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.251|-0.226|0.917
73898291|NCT02880956|147328885|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898292|NCT02880956|147328885|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.124||0.639|TWO_SIDED|95.0|-0.186|0.303||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.303|-0.186|0.639
74081955|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|112.272||||0.0053|TWO_SIDED|95.0|4.07|3097.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3097.22|4.07|0.0053
74081956|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.697||||0.0403|TWO_SIDED|95.0|1.16|662.2|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||662.20|1.16|0.0403
74081957|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|30.247||||0.0361|TWO_SIDED|95.0|1.25|733.32|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||733.32|1.25|0.0361
74081958|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|89.341||||0.0069|TWO_SIDED|95.0|3.43|2326.44|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2326.44|3.43|0.0069
74081959|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|76.034||||0.0081|TWO_SIDED|95.0|3.08|1875.15|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1875.15|3.08|0.0081
74081960|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.018||||0.9931|TWO_SIDED|95.0|0.02|64.41|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||64.41|0.02|0.9931
74081961|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|38.943||||0.0259|TWO_SIDED|95.0|1.55|975.84|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||975.84|1.55|0.0259
74081962|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|57.766||||0.0142|TWO_SIDED|95.0|2.26|1477.88|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1477.88|2.26|0.0142
74081963|NCT01243151|147716141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|48.734||||0.0179|TWO_SIDED|95.0|1.95|1216.9|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1216.90|1.95|0.0179
74081964|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|353.058||||0.0013|TWO_SIDED|95.0|9.95|12528.19|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||12528.19|9.95|0.0013
74081965|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|129.984||||0.0047|TWO_SIDED|95.0|4.44|3808.21|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3808.21|4.44|0.0047
74081966|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|300.099||||0.0018|TWO_SIDED|95.0|8.35|10787.45|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||10787.45|8.35|0.0018
74081967|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|190.835||||0.0025|TWO_SIDED|95.0|6.34|5743.12|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||5743.12|6.34|0.0025
74081968|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|255.421||||0.0018|TWO_SIDED|95.0|7.87|8290.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||8290.22|7.87|0.0018
74081969|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|150.547||||0.0034|TWO_SIDED|95.0|5.28|4291.89|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||4291.89|5.28|0.0034
74081970|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|745.542||||0.0018|TWO_SIDED|95.0|11.6|47929.45|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||47929.45|11.60|0.0018
74081971|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|146.296||||0.0031|TWO_SIDED|95.0|5.4|3963.01|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3963.01|5.40|0.0031
74081972|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|213.512||||0.002|TWO_SIDED|95.0|7.13|6396.64|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||6396.64|7.13|0.0020
74081973|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|124.439||||0.0038|TWO_SIDED|95.0|4.73|3277.13|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3277.13|4.73|0.0038
74081974|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|622.309||||0.002|TWO_SIDED|95.0|10.51|36846.03|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||36846.03|10.51|0.0020
74081975|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|224.427||||0.0017|TWO_SIDED|95.0|7.63|6598.0|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||6598.00|7.63|0.0017
74081976|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.158||||0.2751|TWO_SIDED|95.0|0.24|161.08|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||161.08|0.24|0.2751
74081977|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|152.977||||0.0038|TWO_SIDED|95.0|5.05|4633.92|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||4633.92|5.05|0.0038
74081978|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|756.203||||0.002|TWO_SIDED|95.0|11.18|51133.53|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||51133.53|11.18|0.0020
74081979|NCT01243151|147716142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|258.938||||0.0021|TWO_SIDED|95.0|7.53|8902.61|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||8902.61|7.53|0.0021
74081980|NCT01243151|147716143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.896||||0.958|TWO_SIDED|95.0|0.02|52.79|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||52.79|0.02|0.9580
74081981|NCT01243151|147716143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.375||||0.0732|TWO_SIDED|95.0|0.76|394.65|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||394.65|0.76|0.0732
74081982|NCT01243151|147716143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.86||||0.0159|TWO_SIDED|95.0|2.07|1109.11|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1109.11|2.07|0.0159
74081983|NCT01243151|147716143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|33.246||||0.0264|TWO_SIDED|95.0|1.51|733.62|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||733.62|1.51|0.0264
74081984|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|5.131||0.2883|TWO_SIDED|95.0|-4.77|15.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.77|-4.77|0.2883
74081985|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|6.05|STANDARD_ERROR_OF_MEAN|5.277||0.2563|TWO_SIDED|95.0|-4.51|16.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.61|-4.51|0.2563
74081986|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|5.225||0.7149|TWO_SIDED|95.0|-8.54|12.37|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.37|-8.54|0.7149
74081987|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|3.95|STANDARD_ERROR_OF_MEAN|5.174||0.448|TWO_SIDED|95.0|-6.4|14.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.30|-6.40|0.4480
74081988|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|14.5|STANDARD_ERROR_OF_MEAN|6.214||0.0231|TWO_SIDED|95.0|2.06|26.94|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.94|2.06|0.0231
74081989|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|11.13|STANDARD_ERROR_OF_MEAN|6.369||0.0858|TWO_SIDED|95.0|-1.62|23.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.87|-1.62|0.0858
74081990|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|7.57|STANDARD_ERROR_OF_MEAN|6.431||0.244|TWO_SIDED|95.0|-5.3|20.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.44|-5.30|0.2440
74081991|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|11.52|STANDARD_ERROR_OF_MEAN|6.249||0.0702|TWO_SIDED|95.0|-0.98|24.03|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||24.03|-0.98|0.0702
74081992|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|9.64|STANDARD_ERROR_OF_MEAN|4.878||0.0531|TWO_SIDED|95.0|-0.13|19.41|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.41|-0.13|0.0531
74081993|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|8.93|STANDARD_ERROR_OF_MEAN|4.94||0.0758|TWO_SIDED|95.0|-0.96|18.83|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.83|-0.96|0.0758
74081994|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|4.975||0.6965|TWO_SIDED|95.0|-8.01|11.92|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||11.92|-8.01|0.6965
74081995|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|13.52|STANDARD_ERROR_OF_MEAN|4.842||0.0071|TWO_SIDED|95.0|3.83|23.22|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.22|3.83|0.0071
74081996|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|5.155||0.0339|TWO_SIDED|95.0|0.88|21.52|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||21.52|0.88|0.0339
74081997|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|8.56|STANDARD_ERROR_OF_MEAN|5.235||0.1075|TWO_SIDED|95.0|-1.92|19.03|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.03|-1.92|0.1075
74081998|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|5.98|STANDARD_ERROR_OF_MEAN|5.258||0.2601|TWO_SIDED|95.0|-4.54|16.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.50|-4.54|0.2601
74081999|NCT01243151|147716144|SUPERIORITY_OR_OTHER||LS Mean Difference|9.96|STANDARD_ERROR_OF_MEAN|5.132||0.057|TWO_SIDED|95.0|-0.31|20.24|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.24|-0.31|0.0570
74082000|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.88|STANDARD_ERROR_OF_MEAN|5.008|<|0.0001|TWO_SIDED|95.0|-42.93|-22.84|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.84|-42.93|<0.0001
74082001|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.8|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-41.34|-20.26|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-20.26|-41.34|<0.0001
74082002|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.98|STANDARD_ERROR_OF_MEAN|5.088|<|0.0001|TWO_SIDED|95.0|-50.18|-29.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.77|-50.18|<0.0001
74082003|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.37|STANDARD_ERROR_OF_MEAN|5.07|<|0.0001|TWO_SIDED|95.0|-48.54|-28.2|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-28.20|-48.54|<0.0001
74082004|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.18|STANDARD_ERROR_OF_MEAN|6.271|<|0.0001|TWO_SIDED|95.0|-54.73|-29.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.63|-54.73|<0.0001
74082005|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.69|STANDARD_ERROR_OF_MEAN|6.512|<|0.0001|TWO_SIDED|95.0|-55.72|-29.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.67|-55.72|<0.0001
74082006|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.56|STANDARD_ERROR_OF_MEAN|6.445|<|0.0001|TWO_SIDED|95.0|-67.45|-41.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-41.67|-67.45|<0.0001
74082007|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.89|STANDARD_ERROR_OF_MEAN|6.321|<|0.0001|TWO_SIDED|95.0|-64.54|-39.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.25|-64.54|<0.0001
74082008|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.35|STANDARD_ERROR_OF_MEAN|5.359||95|TWO_SIDED|95.0|-58.1|-36.59|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.59|-58.10|95
73898293|NCT02880956|147328885|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898294|NCT02880956|147328886|SUPERIORITY||LS Mean of Difference|-1.57|STANDARD_ERROR_OF_MEAN|2.175||0.47|TWO_SIDED|95.0|-5.851|2.703||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.703|-5.851|0.470
73898295|NCT02880956|147328886|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|15.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898296|NCT02880956|147328886|SUPERIORITY||LS Mean of Difference|0.36|STANDARD_ERROR_OF_MEAN|2.127||0.864|TWO_SIDED|95.0|-3.819|4.548||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||4.548|-3.819|0.864
73898297|NCT02880956|147328886|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|15.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898298|NCT02880956|147328886|SUPERIORITY||LS Mean of Difference|-4.49|STANDARD_ERROR_OF_MEAN|2.206||0.043|TWO_SIDED|95.0|-8.826|-0.15||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||-0.150|-8.826|0.043
73898299|NCT02880956|147328886|SUPERIORITY||Effect size/pooled SD|-0.28|STANDARD_DEVIATION|16.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898300|NCT02880956|147328886|SUPERIORITY||LS Mean of Difference|0.61|STANDARD_ERROR_OF_MEAN|2.874||0.831|TWO_SIDED|95.0|-5.041|6.27||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||6.270|-5.041|0.831
73898301|NCT02880956|147328886|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|18.06|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898302|NCT02880956|147328886|SUPERIORITY||LS Mean of Difference|1.81|STANDARD_ERROR_OF_MEAN|2.843||0.525|TWO_SIDED|95.0|-3.784|7.404||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||7.404|-3.784|0.525
73898303|NCT02880956|147328886|OTHER||Effect size/pooled SD|0.1|STANDARD_ERROR_OF_MEAN|18.47|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898304|NCT02880956|147328886|SUPERIORITY||LS Mean of Difference|-1.49|STANDARD_ERROR_OF_MEAN|2.921||0.61|TWO_SIDED|95.0|-7.239|4.255||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||4.255|-7.239|0.610
73898305|NCT02880956|147328886|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|19.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898306|NCT02880956|147328887|SUPERIORITY||LS Mean of Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.02||0.438|TWO_SIDED|95.0|-2.798|1.214||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||1.214|-2.798|0.438
73898307|NCT02880956|147328887|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|7.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898308|NCT02880956|147328887|SUPERIORITY||LS Mean of Difference|0.81|STANDARD_ERROR_OF_MEAN|1.005||0.419|TWO_SIDED|95.0|-1.164|2.788||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||2.788|-1.164|0.419
73898309|NCT02880956|147328887|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|7.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
74082009|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.08|STANDARD_ERROR_OF_MEAN|5.566|<|0.0001|TWO_SIDED|95.0|-62.24|-39.91|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.91|-62.24|<0.0001
74082010|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.89|STANDARD_ERROR_OF_MEAN|5.482|<|0.0001|TWO_SIDED|95.0|-70.89|-48.89|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-48.89|-70.89|<0.0001
73898310|NCT02880956|147328887|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|1.03||0.948|TWO_SIDED|95.0|-1.959|2.092||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||2.092|-1.959|0.948
73898311|NCT02880956|147328887|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|8.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898312|NCT02880956|147328887|SUPERIORITY||LS Mean of Difference|-1.04|STANDARD_ERROR_OF_MEAN|1.597||0.516|TWO_SIDED|95.0|-4.18|2.101||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||2.101|-4.180|0.516
73898313|NCT02880956|147328887|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|10.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898314|NCT02880956|147328887|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|1.582||0.971|TWO_SIDED|95.0|-3.055|3.168||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||3.168|-3.055|0.971
73898315|NCT02880956|147328887|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|11.24|||TWO_SIDED|||||||||Week 96||||
73898316|NCT02880956|147328887|SUPERIORITY||LS Mean of Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.621||0.392|TWO_SIDED|95.0|-4.577|1.8||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||1.800|-4.577|0.392
73898317|NCT02880956|147328887|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|10.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898318|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.902||0.148|TWO_SIDED|95.0|-3.08|0.465||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.465|-3.080|0.148
73898319|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|6.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898320|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.896||0.092|TWO_SIDED|95.0|-3.278|0.246||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.246|-3.278|0.092
73898321|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|7.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74082011|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.03|STANDARD_ERROR_OF_MEAN|5.377|<|0.0001|TWO_SIDED|95.0|-67.83|-46.24|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-46.24|-67.83|<0.0001
74082012|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.06|STANDARD_ERROR_OF_MEAN|5.767|<|0.0001|TWO_SIDED|95.0|-60.61|-37.51|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.51|-60.61|<0.0001
73898322|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.915||0.073|TWO_SIDED|95.0|-3.446|0.152||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.152|-3.446|0.073
73898323|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|-0.25|STANDARD_DEVIATION|6.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898324|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|0.47|STANDARD_ERROR_OF_MEAN|1.081||0.662|TWO_SIDED|95.0|-1.652|2.599||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.599|-1.652|0.662
73898325|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|8.07|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898326|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|1.057||0.992|TWO_SIDED|95.0|-2.089|2.068||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.068|-2.089|0.992
73898327|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|8.38|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898328|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|-0.82|STANDARD_ERROR_OF_MEAN|1.088||0.451|TWO_SIDED|95.0|-2.961|1.32||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.320|-2.961|0.451
73898329|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|7.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898330|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|1.227||0.583|TWO_SIDED|95.0|-3.088|1.739||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.739|-3.088|0.583
74082013|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.52|STANDARD_ERROR_OF_MEAN|5.974|<|0.0001|TWO_SIDED|95.0|-63.48|-39.56|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.56|-63.48|<0.0001
74082014|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|5.901|<|0.0001|TWO_SIDED|95.0|-76.04|-52.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.40|-76.04|<0.0001
74082015|NCT01243151|147716145|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.01|STANDARD_ERROR_OF_MEAN|5.785|<|0.0001|TWO_SIDED|95.0|-71.59|-48.42|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-48.42|-71.59|<0.0001
74082016|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.91|STANDARD_ERROR_OF_MEAN|10.392|<|0.0001|TWO_SIDED|95.0|-75.54|-34.29|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.29|-75.54|<0.0001
74082017|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.07|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-65.21|-22.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.94|-65.21|<0.0001
74082018|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.98|STANDARD_ERROR_OF_MEAN|10.547|<|0.0001|TWO_SIDED|95.0|-88.92|-47.05|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.05|-88.92|<0.0001
74082019|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.51|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-81.11|-39.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.90|-81.11|<0.0001
74082020|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-68.39|STANDARD_ERROR_OF_MEAN|10.392|<|0.0001|TWO_SIDED|95.0|-89.02|-47.76|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.76|-89.02|<0.0001
74082021|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.41|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-81.54|-39.27|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.27|-81.54|<0.0001
74082022|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.6|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-107.74|-65.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-65.46|-107.74|<0.0001
74082023|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-81.13|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-101.73|-60.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-60.52|-101.73|<0.0001
74082024|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-80.16|STANDARD_ERROR_OF_MEAN|10.479|<|0.0001|TWO_SIDED|95.0|-100.96|-59.37|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-59.37|-100.96|<0.0001
74082025|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.0|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-104.14|-61.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-61.87|-104.14|<0.0001
74082026|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-104.77|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-125.91|-83.62|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-83.62|-125.91|<0.0001
74082027|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-90.23|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-110.84|-69.63|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.63|-110.84|<0.0001
74082028|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.54|STANDARD_ERROR_OF_MEAN|10.479|<|0.0001|TWO_SIDED|95.0|-92.34|-50.75|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-50.75|-92.34|<0.0001
74082029|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-74.46|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-95.59|-53.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-53.32|-95.59|<0.0001
74082030|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-102.35|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-123.49|-81.21|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-81.21|-123.49|<0.0001
74082031|NCT01243151|147716146|SUPERIORITY_OR_OTHER||LS Mean Difference|-87.15|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-107.76|-66.55|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.55|-107.76|<0.0001
74082032|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.945||0.3064|TWO_SIDED|95.0|-1.89|5.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||5.90|-1.89|0.3064
74082033|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|2.025||0.1922|TWO_SIDED|95.0|-1.38|6.73|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.73|-1.38|0.1922
74082034|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|1.984||0.6827|TWO_SIDED|95.0|-3.16|4.79|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||4.79|-3.16|0.6827
74082035|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|2.45|STANDARD_ERROR_OF_MEAN|1.981||0.2211|TWO_SIDED|95.0|-1.52|6.42|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.42|-1.52|0.2211
74082036|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|6.64|STANDARD_ERROR_OF_MEAN|2.158||0.0033|TWO_SIDED|95.0|2.31|10.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.97|2.31|0.0033
74082037|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|5.09|STANDARD_ERROR_OF_MEAN|2.237||0.0269|TWO_SIDED|95.0|0.6|9.57|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.57|0.60|0.0269
74082038|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|STANDARD_ERROR_OF_MEAN|2.232||0.089|TWO_SIDED|95.0|-0.61|8.34|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.34|-0.61|0.0890
74082039|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|5.08|STANDARD_ERROR_OF_MEAN|2.19||0.0242|TWO_SIDED|95.0|0.69|9.47|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.47|0.69|0.0242
74082040|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|STANDARD_ERROR_OF_MEAN|2.101||0.127|TWO_SIDED|95.0|-0.95|7.46|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.46|-0.95|0.1270
74082041|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.151||0.1199|TWO_SIDED|95.0|-0.91|7.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.70|-0.91|0.1199
74082042|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|2.15||0.8123|TWO_SIDED|95.0|-3.79|4.82|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||4.82|-3.79|0.8123
74082043|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|5.65|STANDARD_ERROR_OF_MEAN|2.106||0.0095|TWO_SIDED|95.0|1.44|9.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.87|1.44|0.0095
74082044|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.492||0.1141|TWO_SIDED|95.0|-0.99|8.99|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.99|-0.99|0.1141
74082045|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.536||0.1552|TWO_SIDED|95.0|-1.42|8.73|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.73|-1.42|0.1552
74082046|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|1.57|STANDARD_ERROR_OF_MEAN|2.547||0.5407|TWO_SIDED|95.0|-3.53|6.67|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.67|-3.53|0.5407
74082047|NCT01243151|147716147|SUPERIORITY_OR_OTHER||LS Mean Difference|6.56|STANDARD_ERROR_OF_MEAN|2.485||0.0107|TWO_SIDED|95.0|1.58|11.53|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||11.53|1.58|0.0107
74082048|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.35|STANDARD_ERROR_OF_MEAN|8.152|<|0.0001|TWO_SIDED|95.0|-76.74|-43.97|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.97|-76.74|<0.0001
74082049|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.53|STANDARD_ERROR_OF_MEAN|8.422|<|0.0001|TWO_SIDED|95.0|-69.45|-35.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-35.61|-69.45|<0.0001
74082050|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-69.46|STANDARD_ERROR_OF_MEAN|8.26|<|0.0001|TWO_SIDED|95.0|-86.06|-52.86|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.86|-86.06|<0.0001
74082051|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.25|STANDARD_ERROR_OF_MEAN|8.112|<|0.0001|TWO_SIDED|95.0|-82.55|-49.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.94|-82.55|<0.0001
74082052|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.46|STANDARD_ERROR_OF_MEAN|10.766|<|0.0001|TWO_SIDED|95.0|-100.05|-56.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-56.87|-100.05|<0.0001
74082053|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.28|STANDARD_ERROR_OF_MEAN|11.051|<|0.0001|TWO_SIDED|95.0|-93.43|-49.13|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.13|-93.43|<0.0001
74082054|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-91.83|STANDARD_ERROR_OF_MEAN|11.018|<|0.0001|TWO_SIDED|95.0|-113.92|-69.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.74|-113.92|<0.0001
74082055|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-89.5|STANDARD_ERROR_OF_MEAN|10.736|<|0.0001|TWO_SIDED|95.0|-111.03|-67.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-67.97|-111.03|<0.0001
74082056|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.73|STANDARD_ERROR_OF_MEAN|8.452|<|0.0001|TWO_SIDED|95.0|-103.73|-69.72|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.72|-103.73|<0.0001
74082057|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-92.18|STANDARD_ERROR_OF_MEAN|8.643|<|0.0001|TWO_SIDED|95.0|-109.57|-74.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.80|-109.57|<0.0001
74082058|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-106.06|STANDARD_ERROR_OF_MEAN|8.585|<|0.0001|TWO_SIDED|95.0|-123.34|-88.78|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-88.78|-123.34|<0.0001
74082059|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-99.18|STANDARD_ERROR_OF_MEAN|8.334|<|0.0001|TWO_SIDED|95.0|-115.95|-82.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-82.40|-115.95|<0.0001
74082060|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-79.07|STANDARD_ERROR_OF_MEAN|8.557|<|0.0001|TWO_SIDED|95.0|-96.22|-61.93|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-61.93|-96.22|<0.0001
74082061|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.89|STANDARD_ERROR_OF_MEAN|8.736|<|0.0001|TWO_SIDED|95.0|-101.4|-66.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.39|-101.40|<0.0001
74082062|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-104.74|STANDARD_ERROR_OF_MEAN|8.679|<|0.0001|TWO_SIDED|95.0|-122.13|-87.35|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-87.35|-122.13|<0.0001
74082063|NCT01243151|147716148|SUPERIORITY_OR_OTHER||LS Mean Difference|-97.0|STANDARD_ERROR_OF_MEAN|8.426|<|0.0001|TWO_SIDED|95.0|-113.89|-80.11|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-80.11|-113.89|<0.0001
74082064|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|29.336||0.448|TWO_SIDED|95.0|-80.08|35.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.49|-80.08|0.4480
74082065|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.52|STANDARD_ERROR_OF_MEAN|30.091||0.2809|TWO_SIDED|95.0|-91.8|26.76|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.76|-91.80|0.2809
74082066|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.92|STANDARD_ERROR_OF_MEAN|29.942||0.2875|TWO_SIDED|95.0|-90.9|27.07|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.07|-90.90|0.2875
74082067|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.52|STANDARD_ERROR_OF_MEAN|29.37||0.5743|TWO_SIDED|95.0|-74.38|41.33|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||41.33|-74.38|0.5743
74082068|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.83|STANDARD_ERROR_OF_MEAN|29.336||0.4997|TWO_SIDED|95.0|-77.62|37.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||37.96|-77.62|0.4997
74082069|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|30.091||0.4756|TWO_SIDED|95.0|-80.78|37.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||37.78|-80.78|0.4756
74082070|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.73|STANDARD_ERROR_OF_MEAN|30.458||0.561|TWO_SIDED|95.0|-77.73|42.26|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||42.26|-77.73|0.5610
74082071|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.41|STANDARD_ERROR_OF_MEAN|29.37||0.4667|TWO_SIDED|95.0|-79.27|36.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||36.44|-79.27|0.4667
74082072|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.7|STANDARD_ERROR_OF_MEAN|29.828||0.3045|TWO_SIDED|95.0|-89.45|28.06|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||28.06|-89.45|0.3045
74082073|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.78|STANDARD_ERROR_OF_MEAN|30.091||0.4301|TWO_SIDED|95.0|-83.06|35.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.50|-83.06|0.4301
74082074|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.15|STANDARD_ERROR_OF_MEAN|30.458||0.0881|TWO_SIDED|95.0|-112.15|7.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.85|-112.15|0.0881
74082075|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.51|STANDARD_ERROR_OF_MEAN|29.37||0.2844|TWO_SIDED|95.0|-89.36|26.35|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.35|-89.36|0.2844
74082076|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.56|STANDARD_ERROR_OF_MEAN|29.828||0.3741|TWO_SIDED|95.0|-85.32|32.19|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||32.19|-85.32|0.3741
74082077|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.88|STANDARD_ERROR_OF_MEAN|30.091||0.4283|TWO_SIDED|95.0|-83.16|35.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.40|-83.16|0.4283
74082078|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.32|STANDARD_ERROR_OF_MEAN|30.458||0.0657|TWO_SIDED|95.0|-116.31|3.68|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||3.68|-116.31|0.0657
74082079|NCT01243151|147716149|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.26|STANDARD_ERROR_OF_MEAN|29.37||0.2586|TWO_SIDED|95.0|-91.11|24.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||24.60|-91.11|0.2586
74082080|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|3.33|STANDARD_ERROR_OF_MEAN|3.404||0.3326|TWO_SIDED|95.0|-3.49|10.14|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.14|-3.49|0.3326
74082081|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|3.69|STANDARD_ERROR_OF_MEAN|3.502||0.2967|TWO_SIDED|95.0|-3.32|10.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.70|-3.32|0.2967
74082082|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|3.466||0.8812|TWO_SIDED|95.0|-6.42|7.46|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.46|-6.42|0.8812
74082083|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|3.42|STANDARD_ERROR_OF_MEAN|3.433||0.3227|TWO_SIDED|95.0|-3.45|10.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.30|-3.45|0.3227
74082084|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|10.01|STANDARD_ERROR_OF_MEAN|4.221||0.021|TWO_SIDED|95.0|1.56|18.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.46|1.56|0.0210
74082085|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|6.84|STANDARD_ERROR_OF_MEAN|4.326||0.1192|TWO_SIDED|95.0|-1.82|15.49|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.49|-1.82|0.1192
74082086|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|5.04|STANDARD_ERROR_OF_MEAN|4.367||0.2529|TWO_SIDED|95.0|-3.69|13.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.78|-3.69|0.2529
74082087|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|7.76|STANDARD_ERROR_OF_MEAN|4.244||0.0725|TWO_SIDED|95.0|-0.73|16.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.25|-0.73|0.0725
74082088|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|6.74|STANDARD_ERROR_OF_MEAN|3.214||0.0405|TWO_SIDED|95.0|0.3|13.18|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.18|0.30|0.0405
74082089|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|6.27|STANDARD_ERROR_OF_MEAN|3.258||0.0593|TWO_SIDED|95.0|-0.25|12.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.80|-0.25|0.0593
74082090|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|1.76|STANDARD_ERROR_OF_MEAN|3.279||0.5936|TWO_SIDED|95.0|-4.81|8.33|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.33|-4.81|0.5936
74082091|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|9.78|STANDARD_ERROR_OF_MEAN|3.192||0.0034|TWO_SIDED|95.0|3.38|16.17|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.17|3.38|0.0034
74082092|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|3.428||0.0305|TWO_SIDED|95.0|0.74|14.46|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.46|0.74|0.0305
74082093|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|5.41|STANDARD_ERROR_OF_MEAN|3.479||0.1252|TWO_SIDED|95.0|-1.55|12.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.37|-1.55|0.1252
74082094|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|3.71|STANDARD_ERROR_OF_MEAN|3.495||0.2923|TWO_SIDED|95.0|-3.28|10.71|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.71|-3.28|0.2923
74082095|NCT01243151|147716150|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|3.411||0.0297|TWO_SIDED|95.0|0.78|14.43|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.43|0.78|0.0297
74082096|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.35|STANDARD_ERROR_OF_MEAN|4.117|<|0.0001|TWO_SIDED|95.0|-34.59|-18.1|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-18.10|-34.59|<0.0001
74082097|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.29|STANDARD_ERROR_OF_MEAN|4.325|<|0.0001|TWO_SIDED|95.0|-32.95|-15.63|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-15.63|-32.95|<0.0001
74082098|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.2|STANDARD_ERROR_OF_MEAN|4.182|<|0.0001|TWO_SIDED|95.0|-39.58|-22.83|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.83|-39.58|<0.0001
74082099|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.43|STANDARD_ERROR_OF_MEAN|4.169|<|0.0001|TWO_SIDED|95.0|-38.78|-22.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.08|-38.78|<0.0001
74082100|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.3|STANDARD_ERROR_OF_MEAN|5.055|<|0.0001|TWO_SIDED|95.0|-43.42|-23.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.19|-43.42|<0.0001
74082101|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.14|STANDARD_ERROR_OF_MEAN|5.255|<|0.0001|TWO_SIDED|95.0|-44.65|-23.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.63|-44.65|<0.0001
74082102|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.57|STANDARD_ERROR_OF_MEAN|5.194|<|0.0001|TWO_SIDED|95.0|-52.96|-32.18|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.18|-52.96|<0.0001
74082103|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.87|STANDARD_ERROR_OF_MEAN|5.097|<|0.0001|TWO_SIDED|95.0|-52.07|-31.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.67|-52.07|<0.0001
74082104|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.75|STANDARD_ERROR_OF_MEAN|4.343|<|0.0001|TWO_SIDED|95.0|-46.46|-29.05|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.05|-46.46|<0.0001
74082105|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.98|STANDARD_ERROR_OF_MEAN|4.519|<|0.0001|TWO_SIDED|95.0|-50.04|-31.93|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.93|-50.04|<0.0001
74082106|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.98|STANDARD_ERROR_OF_MEAN|4.441|<|0.0001|TWO_SIDED|95.0|-55.88|-38.08|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.08|-55.88|<0.0001
74082107|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.77|STANDARD_ERROR_OF_MEAN|4.363|<|0.0001|TWO_SIDED|95.0|-54.52|-37.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.03|-54.52|<0.0001
74082108|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.61|STANDARD_ERROR_OF_MEAN|4.616|<|0.0001|TWO_SIDED|95.0|-47.85|-29.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.37|-47.85|<0.0001
74082109|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.19|STANDARD_ERROR_OF_MEAN|4.795|<|0.0001|TWO_SIDED|95.0|-50.78|-31.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.60|-50.78|<0.0001
74082110|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.75|STANDARD_ERROR_OF_MEAN|4.722|<|0.0001|TWO_SIDED|95.0|-59.2|-40.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-40.30|-59.20|<0.0001
74082111|NCT01243151|147716151|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.04|STANDARD_ERROR_OF_MEAN|4.639|<|0.0001|TWO_SIDED|95.0|-57.33|-38.76|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.76|-57.33|<0.0001
74082112|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|4.211|<|0.0001|TWO_SIDED|95.0|-31.06|-14.34|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-14.34|-31.06|<0.0001
74082113|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-27.17|-10.03|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-10.03|-27.17|<0.0001
74082114|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.97|STANDARD_ERROR_OF_MEAN|4.274|<|0.0001|TWO_SIDED|95.0|-36.46|-19.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-19.49|-36.46|<0.0001
74082115|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.89|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-33.24|-16.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-16.54|-33.24|<0.0001
74082116|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.89|STANDARD_ERROR_OF_MEAN|4.211|<|0.0001|TWO_SIDED|95.0|-37.25|-20.53|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-20.53|-37.25|<0.0001
74082117|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.35|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-34.92|-17.79|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-17.79|-34.92|<0.0001
74082118|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.89|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-44.46|-27.33|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.33|-44.46|<0.0001
74082119|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.23|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-42.58|-25.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.88|-42.58|<0.0001
74082120|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.96|STANDARD_ERROR_OF_MEAN|4.246|<|0.0001|TWO_SIDED|95.0|-42.39|-25.53|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.53|-42.39|<0.0001
74082121|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.41|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-43.98|-26.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-26.85|-43.98|<0.0001
74082122|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.28|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-51.85|-34.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.71|-51.85|<0.0001
74082123|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.0|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-46.35|-29.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.65|-46.35|<0.0001
74082124|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.77|STANDARD_ERROR_OF_MEAN|4.246|<|0.0001|TWO_SIDED|95.0|-38.19|-21.34|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-21.34|-38.19|<0.0001
74082125|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.22|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-39.79|-22.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.65|-39.79|<0.0001
74082126|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.34|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-49.91|-32.78|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.78|-49.91|<0.0001
74082127|NCT01243151|147716152|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.04|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-44.39|-27.69|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.69|-44.39|<0.0001
74082128|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|4.44|STANDARD_ERROR_OF_MEAN|3.975||0.269|TWO_SIDED|95.0|-3.53|12.41|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.41|-3.53|0.2690
74082129|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|5.22|STANDARD_ERROR_OF_MEAN|4.133||0.2122|TWO_SIDED|95.0|-3.07|13.5|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.50|-3.07|0.2122
74082130|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|4.054||0.8953|TWO_SIDED|95.0|-7.59|8.67|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.67|-7.59|0.8953
74082131|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|5.59|STANDARD_ERROR_OF_MEAN|4.045||0.1723|TWO_SIDED|95.0|-2.51|13.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.70|-2.51|0.1723
74082132|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|14.95|STANDARD_ERROR_OF_MEAN|4.293||0.001|TWO_SIDED|95.0|6.34|23.56|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.56|6.34|0.0010
74082133|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|10.86|STANDARD_ERROR_OF_MEAN|4.451||0.0179|TWO_SIDED|95.0|1.95|19.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.78|1.95|0.0179
74082134|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|4.44||0.0462|TWO_SIDED|95.0|0.16|17.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||17.96|0.16|0.0462
74082135|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|11.78|STANDARD_ERROR_OF_MEAN|4.358||0.0091|TWO_SIDED|95.0|3.05|20.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.52|3.05|0.0091
74082136|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|7.31|STANDARD_ERROR_OF_MEAN|4.064||0.0774|TWO_SIDED|95.0|-0.83|15.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.45|-0.83|0.0774
74082137|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16|STANDARD_ERROR_OF_MEAN|4.165||0.0909|TWO_SIDED|95.0|-1.18|15.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.50|-1.18|0.0909
74082138|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|4.157||0.6107|TWO_SIDED|95.0|-6.2|10.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.45|-6.20|0.6107
74082139|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|11.59|STANDARD_ERROR_OF_MEAN|4.076||0.0062|TWO_SIDED|95.0|3.42|19.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.75|3.42|0.0062
74082140|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|8.69|STANDARD_ERROR_OF_MEAN|4.712||0.0702|TWO_SIDED|95.0|-0.74|18.13|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.13|-0.74|0.0702
74082141|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|6.69|STANDARD_ERROR_OF_MEAN|4.807||0.1692|TWO_SIDED|95.0|-2.93|16.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.32|-2.93|0.1692
74082142|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|4.31|STANDARD_ERROR_OF_MEAN|4.819||0.3751|TWO_SIDED|95.0|-5.34|13.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.96|-5.34|0.3751
74082143|NCT01243151|147716153|SUPERIORITY_OR_OTHER||LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|4.709||0.0053|TWO_SIDED|95.0|4.23|23.08|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.08|4.23|0.0053
73898331|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|8.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898332|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|-1.59|STANDARD_ERROR_OF_MEAN|1.213||0.191|TWO_SIDED|95.0|-3.975|0.795||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.795|-3.975|0.191
73898333|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|9.37|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898334|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|-1.11|STANDARD_ERROR_OF_MEAN|1.238||0.372|TWO_SIDED|95.0|-3.541|1.329|||repeated measures model|||Week 72||1.329|-3.541|0.372
73898335|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|8.96|||TWO_SIDED|||||||||Week 72||||
73898336|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|1.303||0.447|TWO_SIDED|95.0|-3.553|1.571||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.571|-3.553|0.447
73898337|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|9.35|||TWO_SIDED|||||||||Week 96||||
73898338|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|1.285||0.881|TWO_SIDED|95.0|-2.334|2.719||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.719|-2.334|0.881
74082144|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.64|STANDARD_ERROR_OF_MEAN|3.951|<|0.0001|TWO_SIDED|95.0|-38.56|-22.72|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.72|-38.56|<0.0001
74082145|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.62|STANDARD_ERROR_OF_MEAN|4.084|<|0.0001|TWO_SIDED|95.0|-34.8|-18.44|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-18.44|-34.80|<0.0001
74082146|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.27|STANDARD_ERROR_OF_MEAN|4.003|<|0.0001|TWO_SIDED|95.0|-43.29|-27.24|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.24|-43.29|<0.0001
73898339|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|8.68|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898340|NCT02880956|147328888|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|1.338||0.853|TWO_SIDED|95.0|-2.881|2.383||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.383|-2.881|0.853
73898341|NCT02880956|147328888|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|8.54|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898342|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.846||0.287|TWO_SIDED|95.0|-2.567|0.762||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.762|-2.567|0.287
73898343|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|6.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74082147|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.42|STANDARD_ERROR_OF_MEAN|3.931|<|0.0001|TWO_SIDED|95.0|-41.3|-25.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.54|-41.30|<0.0001
74082148|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.38|STANDARD_ERROR_OF_MEAN|5.467|<|0.0001|TWO_SIDED|95.0|-52.34|-30.42|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-30.42|-52.34|<0.0001
74082149|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.12|STANDARD_ERROR_OF_MEAN|5.61|<|0.0001|TWO_SIDED|95.0|-49.36|-26.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-26.88|-49.36|<0.0001
74082150|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.42|STANDARD_ERROR_OF_MEAN|5.599|<|0.0001|TWO_SIDED|95.0|-58.64|-36.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.20|-58.64|<0.0001
74082151|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.93|STANDARD_ERROR_OF_MEAN|5.453|<|0.0001|TWO_SIDED|95.0|-57.87|-36.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.00|-57.87|<0.0001
74082152|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.37|STANDARD_ERROR_OF_MEAN|4.275|<|0.0001|TWO_SIDED|95.0|-53.96|-36.77|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.77|-53.96|<0.0001
74082153|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.78|STANDARD_ERROR_OF_MEAN|4.374|<|0.0001|TWO_SIDED|95.0|-57.58|-39.99|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.99|-57.58|<0.0001
74082154|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.49|STANDARD_ERROR_OF_MEAN|4.346|<|0.0001|TWO_SIDED|95.0|-63.23|-45.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.75|-63.23|<0.0001
74082155|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.75|STANDARD_ERROR_OF_MEAN|4.222|<|0.0001|TWO_SIDED|95.0|-60.25|-43.26|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.26|-60.25|<0.0001
74082156|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.82|STANDARD_ERROR_OF_MEAN|4.373|<|0.0001|TWO_SIDED|95.0|-49.58|-32.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.07|-49.58|<0.0001
74082157|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.75|STANDARD_ERROR_OF_MEAN|4.464|<|0.0001|TWO_SIDED|95.0|-52.68|-34.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.81|-52.68|<0.0001
74082158|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.36|STANDARD_ERROR_OF_MEAN|4.437|<|0.0001|TWO_SIDED|95.0|-61.25|-43.48|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.48|-61.25|<0.0001
74082159|NCT01243151|147716154|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.94|STANDARD_ERROR_OF_MEAN|4.312|<|0.0001|TWO_SIDED|95.0|-58.58|-41.31|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-41.31|-58.58|<0.0001
74082160|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|19.581||0.9789|TWO_SIDED|95.0|-39.08|38.04|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||38.04|-39.08|0.9789
74082161|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.94|STANDARD_ERROR_OF_MEAN|20.069||0.5525|TWO_SIDED|95.0|-51.46|27.59|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.59|-51.46|0.5525
74082162|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.39|STANDARD_ERROR_OF_MEAN|19.979||0.5035|TWO_SIDED|95.0|-52.73|25.96|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||25.96|-52.73|0.5035
74082163|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|19.601||0.8302|TWO_SIDED|95.0|-42.81|34.39|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||34.39|-42.81|0.8302
74082164|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.45|STANDARD_ERROR_OF_MEAN|19.581||0.559|TWO_SIDED|95.0|-50.01|27.1|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.10|-50.01|0.5590
74082165|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.84|STANDARD_ERROR_OF_MEAN|20.069||0.5558|TWO_SIDED|95.0|-51.36|27.69|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.69|-51.36|0.5558
74082166|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|20.332||0.6835|TWO_SIDED|95.0|-48.34|31.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||31.74|-48.34|0.6835
74082167|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.15|STANDARD_ERROR_OF_MEAN|19.601||0.5699|TWO_SIDED|95.0|-49.75|27.45|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.45|-49.75|0.5699
74082168|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.42|STANDARD_ERROR_OF_MEAN|19.918||0.3826|TWO_SIDED|95.0|-56.64|21.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||21.80|-56.64|0.3826
74082169|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.83|STANDARD_ERROR_OF_MEAN|20.069||0.5233|TWO_SIDED|95.0|-52.35|26.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.70|-52.35|0.5233
74082170|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.47|STANDARD_ERROR_OF_MEAN|20.332||0.3391|TWO_SIDED|95.0|-59.51|20.57|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.57|-59.51|0.3391
74082171|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.95|STANDARD_ERROR_OF_MEAN|19.601||0.3606|TWO_SIDED|95.0|-56.55|20.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.65|-56.55|0.3606
74082172|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.33|STANDARD_ERROR_OF_MEAN|19.918||0.5364|TWO_SIDED|95.0|-51.55|26.89|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.89|-51.55|0.5364
74082173|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.56|STANDARD_ERROR_OF_MEAN|20.069||0.5651|TWO_SIDED|95.0|-51.08|27.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.96|-51.08|0.5651
74082174|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.65|STANDARD_ERROR_OF_MEAN|20.332||0.4719|TWO_SIDED|95.0|-54.69|25.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||25.39|-54.69|0.4719
74082175|NCT01243151|147716155|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.53|STANDARD_ERROR_OF_MEAN|19.601||0.3999|TWO_SIDED|95.0|-55.13|22.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||22.07|-55.13|0.3999
74082176|NCT03123874|147716173|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.827||||0.9|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial taxa in milk collected with own / sterile pump set-ups.|||||0.9
74082177|NCT03123874|147716174|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.163||||0.3|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean Shannon Diversity Index in milk collected with own / sterile pump set-ups|||||0.3
74082178|NCT03123874|147716175|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first). Random effect was participant ID to account for multiple samples for each participant.|Mean Difference (Final Values)|4.95||||0.0003|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial counts in milk collected with own / sterile pump set-ups.|||||0.0003
74082179|NCT02578641|147716191|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.1942|TWO_SIDED|95.0|0.91|1.56||Between-treatment comparisons were assessed using stratified log-rank test stratified by country and disease stage per randomization stratification.|Log Rank|Log-rank test of Hazards Ration equals 1, using Cox proportional hazards regression.|Hazard ratios were estimated using Cox proportional hazards regression.|||1.56|0.91|0.1942
74082180|NCT01456962|147716219|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.6
74082181|NCT01456962|147716219|SUPERIORITY_OR_OTHER||% change in CD4+:CD8+ T cells ratio|-9.5||||0.4|TWO_SIDED|95.0|-27.3|12.0|||Regression, Linear|Adjusted for treatment group and time on antiretroviral therapy|Change based on a 1 log unit increase in genital:plasma drug ratio|Null hypothesis: Higher genital to plasma antiretroviral drug ratios are not associated with higher cervical CD4+:CD8+ T cell ratios.||12|-27.3|0.4
74082182|NCT01167829|147716231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|183.0|STANDARD_ERROR_OF_MEAN|44.0||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.05
74082183|NCT01694563|147716295|SUPERIORITY|||||||0.05|||||||Fisher Exact|||The primary effectiveness hypothesis for this study was to demonstrate a superiority success rate at 36-months follow-up in patients treated with the AtriCure Synergy Ablation System compared to a pre-established performance goal.||||0.05
74082184|NCT01694563|147716296|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 12 months post-operatively.||||
74082185|NCT01694563|147716296|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 24 months post-operatively.||||
74082186|NCT01694563|147716296|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0||||||||Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 36 months post-operatively.|90% confidence interval using the Clopper-Pearson method.|||
74082187|NCT03068780|147716308|SUPERIORITY||Odds Ratio (OR)|1.84||||0.013|TWO_SIDED|95.0|1.02|3.3||P-value adjusted with CHW method using CMH test statistics based on a test stratified by EB subtype and target wound size class estimated separately before and after the interim analysis for sample size re-estimation.Threshold of superiority p\<0.05.|Cui, Hung, Wang (CHW) approach|Primary efficacy endpoint was first assessed with the CMH test, but the final statistical analysis was performed based on the CHW approach.|The CMH test statistic from the data until the interim analysis (IA) and the CMH test statistic of the data after the IA must be calculated separately. The results are then combined using the CHW weighted approach to one test-statistic.|||3.30|1.02|0.013
74082188|NCT03068780|147716309|SUPERIORITY|||||||0.302||||||Threshold of superiority is p\<0.05|Chi-squared|||||||0.302
74082189|NCT01945580|147716316|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.20 (power 80%), 362 subjects (181 subjects per arm) are needed to detect non-inferiority of transvaginal biologic to native tissue repair, using a margin of 12.0%.|Adjusted Difference in Percentages|0.2|||||TWO_SIDED|90.0|-5.6|5.9|||||The propensity adjusted treatment difference of Xenform transvaginal mesh (TVM) minus NTR was estimated and missing data was handled using multiple imputation method.|||5.9|-5.6|
74082190|NCT01945580|147716317|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.10 (power 90%), 308 subjects (154 subjects per arm) are needed to detect non-inferiority with a margin of 11.6%.|Adjusted Difference in Percentages|2.0|||||TWO_SIDED|90.0|-0.8|4.7|||||The propensity score adjusted difference in SAE rate of Xenform transvaginal mesh (TVM) vs. NTR was estimated.|||4.7|-0.8|
74082191|NCT00840658|147716371|SUPERIORITY|||||||0.036|TWO_SIDED|95.0||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the odds of higher receptive needle sharing. (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in receptive needle sharing but the control group will not.)|To examine the receptive needle sharing outcome, we used ordinal logistic regression for correlated data via GEE with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final ordinal logistic regression models included the following main effects: Group, Visit, and Visit\*Group interaction, with our primary interest in the Visit\*Group interaction, as a significant p-value would be indicative of an intervention effect.|||0.036
74082192|NCT00840658|147716372|SUPERIORITY|||||||0.013|TWO_SIDED|95.0||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the mean score IRI (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in the IRI but the control group will not.)|We used gamma regression for correlated data via GEE, with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final gamma regression models included the following main effects: Group, Visit, and Visit\*Group interaction, with our primary interest in the Visit\*Group interaction, as a significant p-value would be indicative of an intervention effect.|||0.013
74082193|NCT02420353|147716430|OTHER|||||||0.0498|||||||Mixed Models Analysis|||Mixed effect model||||0.0498
74082194|NCT02420353|147716431|OTHER|Mixed effects model||||||0.7024|||||||Mixed Models Analysis|||||||0.7024
74082195|NCT02420353|147716432|OTHER|Mixed effects model||||||0.135|||||||Mixed Models Analysis|||||||0.135
74082196|NCT02420353|147716433|OTHER|Mixed effects model||||||0.6836|||||||Mixed Models Analysis|||||||0.6836
74082197|NCT02420353|147716434|OTHER|mixed effects model||||||0.9271|||||||Mixed Models Analysis|||||||0.9271
74082198|NCT02420353|147716435|OTHER|mixed effects model||||||0.1576|||||||Mixed Models Analysis|||||||0.1576
74082199|NCT02420353|147716436|OTHER|mixed effects model||||||0.5586|||||||Mixed Models Analysis|||||||0.5586
74082200|NCT02420353|147716437|OTHER|mixed effects model||||||0.45|||||||Mixed Models Analysis|||||||0.45
74082201|NCT02420353|147716438|OTHER|mixed effects model||||||0.8573|||||||Mixed Models Analysis|||||||0.8573
74082202|NCT02420353|147716439|OTHER|mixed effects model||||||0.0564|||||||Mixed Models Analysis|||||||0.0564
74082203|NCT02420353|147716440|OTHER|mixed effects model||||||0.7883|||||||Mixed Models Analysis|||||||0.7883
74082204|NCT02420353|147716441|OTHER|mixed effects model||||||0.0901|||||||Mixed Models Analysis|||||||0.0901
74082205|NCT02420353|147716442|OTHER|mixed effects model||||||0.6292|||||||Mixed Models Analysis|||||||0.6292
74082206|NCT02420353|147716443|OTHER|mixed effects model||||||0.161|||||||Mixed Models Analysis|||||||0.161
74082207|NCT02420353|147716444|OTHER|mixed effects model||||||0.4437|||||||Mixed Models Analysis|||||||0.4437
74082208|NCT02420353|147716445|OTHER|mixed effects model||||||0.7325|||||||Mixed Models Analysis|||||||0.7325
74082209|NCT02420353|147716446|OTHER|Mixed effects analysis||||||0.6291|||||||Mixed Models Analysis|||||||0.6291
74082210|NCT02420353|147716447|OTHER|Mixed-effects model||||||0.3332|||||||Mixed Models Analysis|||||||0.3332
74082211|NCT02420353|147716448|OTHER|Mixed effects analysis||||||0.79|||||||Mixed Models Analysis|||||||0.79
74082212|NCT02420353|147716449|OTHER|Mixed effects analysis||||||0.4965|||||||Mixed Models Analysis|||||||0.4965
74082213|NCT02420353|147716450|OTHER|mixed effects analysis||||||0.1331|||||||Mixed Models Analysis|||||||0.1331
74082214|NCT02420353|147716451|OTHER|Mixed-model analysis||||||0.5251|||||||Mixed Models Analysis|||||||0.5251
74082215|NCT02420353|147716452|OTHER|Mixed effects analysis||||||0.1064|||||||Mixed Models Analysis|||||||0.1064
74082216|NCT02420353|147716453|OTHER|Mixed effects analysis||||||0.4852|||||||Mixed Models Analysis|||||||0.4852
74082217|NCT02420353|147716454|OTHER|||||||0.7943|||||||Mixed Models Analysis|||||||0.7943
74082218|NCT02420353|147716455|OTHER|||||||0.0894|||||||Mixed Models Analysis|||||||0.0894
74082219|NCT02420353|147716456|OTHER|Mixed effects analysis||||||0.0673|||||||Mixed Models Analysis|||||||0.0673
74082220|NCT02420353|147716457|OTHER|Mixed effects analysis||||||0.0185|||||||Mixed Models Analysis|||||||0.0185
74082221|NCT02420353|147716458|OTHER|mixed effects analysis||||||0.6094|||||||Mixed Models Analysis|||||||0.6094
74082222|NCT02420353|147716459|OTHER|mixed effects analysis||||||0.3279|||||||Mixed Models Analysis|||||||0.3279
74082223|NCT02420353|147716460|OTHER|mixed effects analysis||||||0.2802|||||||Mixed Models Analysis|||||||0.2802
74082224|NCT02420353|147716461|OTHER|||||||0.1064|||||||Mixed Models Analysis|||||||0.1064
74082225|NCT02420353|147716462|OTHER|mixed effects model||||||0.0509|||||||Mixed Models Analysis|||||||0.0509
74082226|NCT02420353|147716463|OTHER|mixed effects analysis||||||0.1605|||||||Mixed Models Analysis|||||||0.1605
74082227|NCT02420353|147716464|OTHER|mixed effects model||||||0.0357|||||||Mixed Models Analysis|||||||0.0357
74082228|NCT02420353|147716465|OTHER|mixed effects model||||||0.0122|||||||Mixed Models Analysis|||||||0.0122
74082229|NCT02420353|147716466|OTHER|mixed effects model||||||0.5853|||||||Mixed Models Analysis|||||||0.5853
74082230|NCT02420353|147716467|OTHER|mixed effects model||||||0.6288|||||||Mixed Models Analysis|||||||0.6288
74082231|NCT02420353|147716468|OTHER|mixed effects model||||||0.5022|||||||Mixed Models Analysis|||||||0.5022
74082232|NCT02420353|147716469|OTHER|mixed effects model||||||0.7507|||||||Mixed Models Analysis|||||||0.7507
74082233|NCT02420353|147716470|OTHER|mixed effects model|||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
74082234|NCT02420353|147716471|OTHER|mixed effects model||||||0.8581|||||||Mixed Models Analysis|||||||0.8581
74082235|NCT02420353|147716472|OTHER|mixed effects model||||||0.0208|||||||Mixed Models Analysis|||||||0.0208
74082236|NCT02420353|147716473|OTHER|Mixed effects model||||||0.8581|||||||Mixed Models Analysis|||||||0.8581
74082237|NCT01149057|147716474|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.||||<0.0001
74082238|NCT01149057|147716475|SUPERIORITY_OR_OTHER|||||||0.3778|TWO_SIDED|||||P value by analysis of covariance (ANCOVA) for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of L1-L4 T-scores||||0.3778
74082239|NCT01149057|147716475|SUPERIORITY_OR_OTHER|||||||0.1541|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total spine T-score||||0.1541
74082240|NCT01149057|147716475|SUPERIORITY_OR_OTHER|||||||0.789|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total hip - left T-score||||0.7890
74082241|NCT01149057|147716475|SUPERIORITY_OR_OTHER|||||||0.7094|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Femoral neck - left T-scores.||||0.7094
74082242|NCT01149057|147716481|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24||||<0.0001
74082243|NCT01149057|147716481|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48||||<0.0001
74082244|NCT01149057|147716481|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72||||<0.0001
74082245|NCT01149057|147716481|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96||||<0.0001
74082246|NCT01149057|147716482|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
74082247|NCT01149057|147716483|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
74082248|NCT01149057|147716484|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
74082249|NCT01149057|147716485|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.||||<0.0001
74082250|NCT01149057|147716486|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
74082251|NCT01149057|147716487|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
74082252|NCT01149057|147716488|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
74082253|NCT01149057|147716489|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24||||<0.0001
74082254|NCT01149057|147716489|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48||||<0.0001
74082255|NCT01149057|147716489|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72||||<0.0001
74082256|NCT01149057|147716489|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96||||<0.0001
74082257|NCT00577655|147716502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.496||||0.0138|TWO_SIDED|95.0|0.729|6.262||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.||6.262|0.729|0.0138
74082258|NCT00577655|147716503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.431||||0.0403|TWO_SIDED|95.0|0.244|10.618||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.||10.618|0.244|0.0403
74082259|NCT00577655|147716504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.536||||0.0031|TWO_SIDED|95.0|1.567|7.505||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."||7.505|1.567|0.0031
74082260|NCT00577655|147716504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.067||||0.047|TWO_SIDED|95.0|0.041|6.094||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."||6.094|0.041|0.0470
74082261|NCT00577655|147716505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.572||||0.0074|TWO_SIDED|95.0|2.077|13.067||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."||13.067|2.077|0.0074
74082262|NCT00577655|147716505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.782||||0.1843|TWO_SIDED|95.0|-1.832|9.397||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."||9.397|-1.832|0.1843
74082263|NCT00577655|147716506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.707||||0.0507|TWO_SIDED|95.0|-0.03|19.445||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline||19.445|-0.030|0.0507
74082264|NCT00577655|147716506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.892||||0.924|TWO_SIDED|95.0|-17.634|19.419||significance level of 0.05.|ANOVA|terms for treatment and center|Active - Placebo|Day 1 Baseline||19.419|-17.634|0.9240
74082265|NCT00577655|147716507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.124||||0.2186|TWO_SIDED|95.0|-18.169|78.417||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline||78.417|-18.169|0.2186
74082266|NCT00577655|147716507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.578||||0.2375|TWO_SIDED|95.0|-28.541|113.7||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 1 Baseline||113.70|-28.541|0.2375
74082267|NCT00577655|147716508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.524||||0.0017|TWO_SIDED|95.0|2.524|10.523||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 1||10.523|2.524|0.0017
74082268|NCT00577655|147716508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.998||||0.0521|TWO_SIDED|95.0|-0.037|8.032||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 22||8.032|-0.037|0.0521
74082269|NCT00577655|147716509|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.477||||0.0647|TWO_SIDED|95.0|0.98|2.23||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1||2.23|0.98|0.0647
74082270|NCT00577655|147716509|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|2.088||||0.0005|TWO_SIDED|95.0|1.38|3.15||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22||3.15|1.38|0.0005
74082271|NCT00577655|147716510|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.141||||0.5059|TWO_SIDED|95.0|0.77|1.69||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1||1.69|0.77|0.5059
74082272|NCT00577655|147716510|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.533||||0.0333|TWO_SIDED|95.0|1.03|2.27||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22||2.27|1.03|0.0333
74082273|NCT00577655|147716511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3888||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.3888
74082274|NCT00577655|147716511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1249||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.1249
74082275|NCT00577655|147716512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0343||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0343
74082276|NCT00577655|147716512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0962||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0962
74082277|NCT00577655|147716513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0109
74082278|NCT00577655|147716513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0845||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0845
74082279|NCT00577655|147716514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0013
74082280|NCT00577655|147716514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0085
74082281|NCT00577655|147716515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.072||||0.4674|TWO_SIDED|95.0|-0.265|0.122||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1||0.122|-0.265|0.4674
74082282|NCT00577655|147716515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.171||||0.084|TWO_SIDED|95.0|-0.365|0.023||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 2||0.023|-0.365|0.0840
74082283|NCT00577655|147716515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.138||||0.1699|TWO_SIDED|95.0|-0.335|0.059||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 3||0.059|-0.335|0.1699
74082284|NCT00577655|147716517|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.926||||0.1391|TWO_SIDED|95.0|-3.256|23.108||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1||23.108|-3.256|0.1391
74082285|NCT00577655|147716517|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.923||||0.1043|TWO_SIDED|95.0|-2.278|24.124||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 2||24.124|-2.278|0.1043
74082286|NCT00577655|147716517|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.546||||0.157|TWO_SIDED|95.0|-3.705|22.798||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 3||22.798|-3.705|0.1570
74082287|NCT00577655|147716518|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.989||||0.9846|TWO_SIDED|95.0|-0.121|2.099||significance level of 0.05.|mixed poisson regression model|||"Week 1~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||2.099|-0.121|0.9846
74082288|NCT00577655|147716518|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.961||||0.9447|TWO_SIDED|95.0|-0.116|2.039||significance level of 0.05.|mixed poisson regression model|||"Week 2~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||2.039|-0.116|0.9447
74082289|NCT00577655|147716518|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.887||||0.8326|TWO_SIDED|95.0|-0.111|1.885||significance level of 0.05.|mixed poisson regression model|||"Week 3~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||1.885|-0.111|0.8326
74082290|NCT01370863|147716530|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-1.452||||0.869|TWO_SIDED|95.0|-19.054|16.149|||ANCOVA|||||16.149|-19.054|0.869
74082291|NCT01370863|147716531|SUPERIORITY_OR_OTHER_LEGACY||Diference in LS means|0.264||||0.487|TWO_SIDED|95.0|-0.495|1.024|||ANCOVA|||||1.024|-0.495|0.487
74082292|NCT01370863|147716532|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.087||||0.637|TWO_SIDED|95.0|-0.501|0.326|||ANCOVA|||||0.326|-0.501|0.637
74082293|NCT00834561|147716541|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.14||||||90.0|99.99|108.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.47|99.99|
74082294|NCT00834561|147716542|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.07||||||90.0|101.33|106.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.89|101.33|
74082295|NCT00834561|147716543|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.68||||||90.0|101.42|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.00|101.42|
74082296|NCT02442687|147716544|OTHER|||||||0.034||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.034
74082297|NCT02442687|147716544|OTHER|||||||0.1731||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.1731
74082298|NCT02442687|147716545|OTHER|||||||0.5276||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.5276
74082299|NCT02442687|147716545|OTHER|||||||0.4968||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.4968
74082300|NCT02442687|147716546|OTHER|||||||0.2591||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.2591
74082301|NCT02442687|147716546|OTHER|||||||0.1806||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.1806
74082302|NCT02442687|147716547|OTHER|||||||0.0882||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.0882
74082303|NCT02442687|147716547|OTHER|||||||0.253||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.2530
74082304|NCT01597791|147716576|SUPERIORITY|||||||0.05||||||Calculated.|Fisher Exact|||||||.05
74082305|NCT01087502|147716577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.6|-0.24|||ANCOVA|||||-0.24|-0.60|<0.0001
74082306|NCT01087502|147716579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.29|STANDARD_ERROR_OF_MEAN|6.59||0.1602||95.0|-22.28|3.7|||ANCOVA|||||3.7|-22.28|0.1602
74082307|NCT01151618|147716585|OTHER|"Sensitivity and Specificity of values with respect to the Mead Whittenberger method were computed as follows (FL=flow limited and NFL = Non Flow limited):~Sensitivity = (# of FL breaths detected by FOT / # of FL breaths detected by M\&W) \* 100 Specificity =(# of NFL breaths detected by FOT / # of NFL breaths detected by M\&W) \* 100"|DeltaXrs (cmH2O*s/L)|2.6|||||TWO_SIDED|90.0|0.0|100.0|||||DeltaXrs equals average inspiratory reactance minus average expiratory reactance.|||100|0|
74082308|NCT01451541|147716598|SUPERIORITY_OR_OTHER||LS Means with adjusted pvalues|0.59|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).||||<0.05
74082309|NCT01451541|147716598|SUPERIORITY_OR_OTHER||LS Means with adjusted p-values.|0.47|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).||||<0.05
74082310|NCT01046084|147716628|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||TWO_SIDED|90.0|86.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123|86.5|
74082311|NCT01046084|147716629|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.0|||||TWO_SIDED|90.0|89.3|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||120|89.3|
74082312|NCT01046084|147716630|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.0|||||TWO_SIDED|90.0|92.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123|92.5|
74082313|NCT00840879|147716740|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.15||||||90.0|90.96|105.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.90|90.96|
74082314|NCT00840879|147716741|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.34||||||90.0|91.82|101.07|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.07|91.82|
74082315|NCT00840879|147716742|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.76||||||90.0|93.31|102.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.42|93.31|
74082316|NCT03247686|147716752|SUPERIORITY|||||||4.96e-05|||||||t-test, 2 sided|||Module M1.2 Placebo versus RSLV-132 All||||0.0000496
74082317|NCT03247686|147716752|SUPERIORITY|||||||1.03e-05|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 All||||0.0000103
74082318|NCT03247686|147716752|SUPERIORITY|||||||0.0004398|||||||t-test, 2 sided|||Module M5.12 Placebo versus RSLV-132 All||||0.0004398
74082319|NCT03247686|147716752|SUPERIORITY|||||||6.8e-06|||||||t-test, 2 sided|||Module 1.2 Placebo versus RSLV-132 Responders||||0.0000068
74082320|NCT03247686|147716752|SUPERIORITY|||||||2e-07|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 Responders||||0.0000002
74082321|NCT03247686|147716752|SUPERIORITY|||||||9.26e-05|||||||t-test, 2 sided|||Module 5.12 Placebo versus RSLV-132 Responders||||0.0000926
74082322|NCT03247686|147716752|SUPERIORITY|||||||0.001545|||||||t-test, 2 sided|||Module M1.2 Placebo versus RSLV-132 Non-responders||||0.0015450
74082323|NCT03247686|147716752|SUPERIORITY|||||||0.0004632|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 Non-responders||||0.0004632
74082324|NCT03247686|147716752|SUPERIORITY|||||||0.009696|||||||t-test, 2 sided|||Module M5.12||||0.0096960
74082325|NCT03247686|147716753|EQUIVALENCE|Two sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|-2.5||||0.18|TWO_SIDED|95.0|-6.34|1.34|||t-test, 2 sided|||Mean difference in change from baseline (95% CI)||1.34|-6.34|0.180
74082326|NCT02906813|147716771|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Ratio|0.631||||0.079|TWO_SIDED|90.0|0.411|0.969|||ANOVA|||Analysis of variance (ANOVA) was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period and regimen, and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative bioavailability (BA) of TAK-935 tablet to solution. Point estimate and 90 percent (%) confidence interval (CI) in original scale were obtained by exponentiation of differences in natural-log scale.||0.969|0.411|0.079
74082327|NCT02906813|147716771|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.403||||0.002|TWO_SIDED|90.0|0.262|0.618|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% confidence interval in original scale were obtained by exponentiation of differences in natural-log scale.||0.618|0.262|0.002
74082328|NCT02906813|147716772|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.85||||0.146|TWO_SIDED|90.0|0.706|1.024|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.024|0.706|0.146
74082329|NCT02906813|147716772|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.889||||0.281|TWO_SIDED|90.0|0.738|1.07|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.070|0.738|0.281
74082330|NCT02906813|147716773|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.842||||0.191|TWO_SIDED|90.0|0.676|1.05|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.050|0.676|0.191
74082331|NCT02906813|147716773|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.894||||0.355||90.0|0.726|1.1|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.100|0.726|0.355
74082332|NCT04364854|147716848|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-2.31|1.87|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||1.87|-2.31|
74082333|NCT04364854|147716848|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-2.94|3.15|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||3.15|-2.94|
74082334|NCT04364854|147716848|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|-0.78|||||TWO_SIDED|95.0|-2.9|1.33|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||1.33|-2.9|
74082335|NCT04364854|147716849|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.26|0.13|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||0.13|-0.26|
74082336|NCT04364854|147716849|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.21|0.28|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||0.28|-0.21|
74082337|NCT04364854|147716849|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.42|-0.04|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||-0.04|-0.42|
74082338|NCT04364854|147716850|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-2.59|2.9|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Narrative, and age.|||2.9|-2.59|
74082339|NCT04364854|147716850|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.79|||||TWO_SIDED|95.0|-2.23|3.8|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM-Narrative, and age.|||3.8|-2.23|
74082340|NCT04364854|147716850|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-2.32|2.82|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Narrative, and age.|||2.82|-2.32|
74082341|NCT04364854|147716851|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-3.59|3.45|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||3.45|-3.59|
74082342|NCT04364854|147716851|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-4.27|4.8|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||4.8|-4.27|
74082343|NCT04364854|147716851|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-2.11|||||TWO_SIDED|95.0|-5.77|1.56|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||1.56|-5.77|
74082344|NCT02435433|147716852|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0199|TWO_SIDED|95.0|0.531|0.949|||Log Rank||Stratified analysis|||0.949|0.531|0.0199
74082345|NCT02435433|147716853|SUPERIORITY||Hazard Ratio (HR)|0.452|||<|0.0001|TWO_SIDED|95.0|0.339|0.603|||Log Rank||Stratified analysis|||0.603|0.339|<0.0001
74082346|NCT02435433|147716854|SUPERIORITY||Hazard Ratio (HR)|0.427|||<|0.0001|TWO_SIDED|95.0|0.313|0.582|||Log Rank||Stratified analysis|||0.582|0.313|<0.0001
74082347|NCT02435433|147716855|SUPERIORITY||Odds Ratio (OR)|4.6||||0.1697|TWO_SIDED|95.0|0.6|37.3|||Cochran-Mantel-Haenszel||Stratified analysis|||37.3|0.6|0.1697
74082348|NCT02435433|147716859|SUPERIORITY||Hazard Ratio (HR)|0.799||||0.2382|TWO_SIDED|95.0|0.545|1.171|||Log Rank||Stratified analysis|||1.171|0.545|0.2382
74082349|NCT01710358|147716874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|||||||0.001
74082350|NCT04406194|147716943|EQUIVALENCE|0.80-1.25 margins for equivalence|Mean Ratio|0.9684||||0|TWO_SIDED|90.0|0.94|0.9977|||ANOVA|||||0.9977|0.9400|0.0000
74082351|NCT04406194|147716944|EQUIVALENCE|0.80 - 1.25 equivalence margin is required.|Mean Ratio|1.0555||||0.0155|TWO_SIDED|90.0|0.9292|1.1989|||ANOVA|||||1.1989|0.9292|0.0155
74082352|NCT04406194|147716945|EQUIVALENCE|0.80 - 1.25 equivalence margin is not required.|Mean Ratio|0.9719||||0|TWO_SIDED|90.0|0.944|1.0006|||ANOVA|||||1.0006|0.9440|0.0000
74082353|NCT00396162|147716947|SUPERIORITY_OR_OTHER|||||||0.23|||||||t-test, 2 sided|||||||0.23
74082354|NCT00396162|147716948|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||||||.31
74082355|NCT02704091|147717008|SUPERIORITY|"The following Null-hypothesis was tested:~H0: λA(t) = λB (t) versus H1: λA(t) ≠ λB (t), where λ(t) represents the hazard at time t, A=diosmectite and B=placebo."|||||=|0.2524|||||||Wilcoxon-Gehan test|||The primary analysis tested the equality of time to recovery between the 2 treatment groups, applying the 2-sided Gehan-Wilcoxon test (α=5%).||||=0.2524
74082356|NCT02704091|147717009|SUPERIORITY||||||=|0.3511|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to recovery, analysed using the Gehan-Wilcoxon test.||||=0.3511
74082357|NCT02704091|147717010|SUPERIORITY||||||=|0.7285|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to first formed stool, analysed using the Gehan-Wilcoxon test.||||=0.7285
74082358|NCT02704091|147717011|SUPERIORITY||||||=|0.1807|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from first study treatment intake to last watery stool, analysed using the Gehan-Wilcoxon test.||||=0.1807
74082359|NCT02704091|147717012|SUPERIORITY||Least Squares (LS) Mean Difference|-0.04||||0.4294|TWO_SIDED|95.0|-0.15|0.07|||ANCOVA|||Comparison between the 2 treatment groups for number of stools for the overall time period, based on an analysis of covariance (ANCOVA) method for repeated measurements. The model included the number of stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.||0.07|-0.15|0.4294
74082360|NCT02704091|147717013|SUPERIORITY||LS Mean Difference|-0.12||||0.0465|TWO_SIDED|95.0|-0.24|0.0|||ANCOVA|||Comparison between the 2 treatment groups for number of watery stools for the overall time period, based on an ANCOVA method for repeated measurements. The model included the number of watery stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.||-0.00|-0.24|0.0465
74082361|NCT02640235|147717043|NON_INFERIORITY|The logistic regression estimates are generated from predicted values of the fitted logistic regression model. If the lower bound of the 95% confidence interval is greater than -10, Celstat is non-inferior to Surgicel. If the lower bound of the 95% confidence interval is greater than 0, Celstat will be declared superior to Surgicel.|Difference in avg predicted proportion|-8.5|||||TWO_SIDED|95.0|-15.6|-1.4|||Regression, Logistic|||||-1.4|-15.6|
74082362|NCT02640235|147717046|OTHER||Difference in avg predicted proportion|4.7|||||TWO_SIDED|95.0|-3.6|13.1|||Regression, Logistic|||||13.1|-3.6|
74082363|NCT02640235|147717047|OTHER||Difference in avg predicted proportion|-6.2|||||TWO_SIDED|95.0|-12.0|-0.5|||Regression, Logistic|||||-0.5|-12|
74082364|NCT02640235|147717048|OTHER||Difference in avg predicted proportion|-0.7|||||TWO_SIDED|95.0|-5.7|4.3|||Regression, Logistic|||||4.3|-5.7|
74082365|NCT02640235|147717049|OTHER||Difference in avg predicted proportion|0.2|||||TWO_SIDED|95.0|-3.9|4.4|||Regression, Logistic|||||4.4|-3.9|
74082366|NCT00270634|147717058|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|-3.2|||||ONE_SIDED|95.0||1.3|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|The 6-month BPAR rate was used to calculate an estimate of the difference in rates between each VCS group and TAC, combining across pooled investigative center strata, weighted by the number of patients in each of the pooled center strata. The overall standard error was estimated for the linear combination of proportions. Using this statistic and its standard error, the upper bound one-sided 95% C.I. was constructed for the difference in BPAR rates between groups (VCS - TAC).||1.3||
74082367|NCT00270634|147717058|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.6|||||ONE_SIDED|95.0||10.8|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|||10.8||
74082368|NCT00270634|147717058|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.9|||||ONE_SIDED|95.0||11.4|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|||11.4||
74088218|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.31|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.67|-1.31|<.0001
74082369|NCT01968551|147717065|NON_INFERIORITY_OR_EQUIVALENCE|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA\<50 copies/mL at Week 24.|Difference in proportion|5.3||||0.23|TWO_SIDED|95.001|-3.4|17.4|||Fisher Exact||Difference in percentages of virologic success and its 95.001% confidence interval (CI) calculation was based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with standardized statistic.|||17.4|-3.4|0.23
74082370|NCT01968551|147717066|NON_INFERIORITY_OR_EQUIVALENCE|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 48.|Difference in proportion|18.3||||0.004|TWO_SIDED|95.001|3.5|33.0|||Fisher Exact||Difference in percentages of virologic success and its 95.001% CI were calculated based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.|||33.0|3.5|0.004
74082371|NCT00431041|147717077|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
74082372|NCT00431041|147717078|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value represents overall comparison of severity of dry mouth.|Chi-squared|||||||0.0010
74082373|NCT00573313|147717082|SUPERIORITY_OR_OTHER||Ratio of Geometric Means at 24 weeks.|0.1505|STANDARD_ERROR_OF_MEAN|0.1615||0.36|TWO_SIDED|95.0|-0.1853|0.4863||The data provided here are for changes in serum AST levels as representative of all clinical laboratory parameters measured.|ANCOVA|Analysis of covariance controlled for baseline data, e.g. AST.|Obtained median values and ranges and log transformations of SD.|Power calculation indicated that a sample size of 20 subjects per treatment arm would detect differences between groups of 0.9 within-subject standard deviations or higher at 80% power and 5% level of significance.||0.4863|-0.1853|0.36
74082374|NCT02096705|147717107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.0968|<|0.0001|TWO_SIDED|95.0|-1.09|-0.71||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.71|-1.09|<0.0001
74082375|NCT02096705|147717108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.69|STANDARD_ERROR_OF_MEAN|4.605|<|0.0001|TWO_SIDED|95.0|-39.76|-21.61|||Longitudinal repeated measure analysis|P-value for Dapagliflozin vs. placebo|Difference of Dapagliflozin from placebo|||-21.61|-39.76|<0.0001
74082376|NCT02096705|147717109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.3057|<|0.0001|TWO_SIDED|95.0|-1.98|-0.77||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.77|-1.98|<0.0001
74082377|NCT02096705|147717110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|STANDARD_ERROR_OF_MEAN|0.5171||0.0059|TWO_SIDED|95.0|-2.45|-0.42||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.42|-2.45|0.0059
74082378|NCT02235870|147717111|SUPERIORITY||Least-Square Mean Difference|3.28||||0.0261|TWO_SIDED|95.0|2.24|4.32|||ANCOVA|||||4.32|2.24|0.0261
74082379|NCT02235870|147717112|SUPERIORITY||Exact Confidence Interval|64.9|||<|0.0001|TWO_SIDED|95.0|57.5|71.7|||Exact Test|||Subjects in the Obalon Treatment group with at least 2 Balloons and balloon therapy for at least 18 weeks.||71.7|57.5|<0.0001
74082380|NCT02235870|147717113|SUPERIORITY||Percentage Difference|32.8|||<|0.0001|TWO_SIDED|95.0|23.1|42.5|||Chi-squared|||||42.5|23.1|<0.0001
74082381|NCT02597049|147717172|SUPERIORITY||Mean Difference (Final Values)|-0.79|||<|0.001|TWO_SIDED|95.0|-0.97|-0.61|||Mixed Models Analysis|||||-0.61|-0.97|<.001
74082382|NCT02597049|147717172|SUPERIORITY||Mean Difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.84|-0.49|||Mixed Models Analysis|||||-0.49|-0.84|< .001
74082383|NCT02597049|147717173|SUPERIORITY||Mean Difference (Final Values)|-0.82|||<|0.001|TWO_SIDED|95.0|-1.0|-0.64|||Mixed Models Analysis|||||-0.64|-1.00|<.001
74082384|NCT02597049|147717173|SUPERIORITY||Mean Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.86|-0.51|||Mixed Models Analysis|||||-0.51|-0.86|<.001
74082385|NCT02597049|147717174|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand||||< .001
74082386|NCT02597049|147717174|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand||||< .001
74082387|NCT02597049|147717174|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand||||< .001
74082388|NCT02597049|147717174|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand||||< .001
74082389|NCT02597049|147717175|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.027|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||Treatment-regimen Estimand||-0.1|-1.8|0.027
74082390|NCT02597049|147717175|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.264|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||Treatment-regimen Estimand||0.4|-1.3|0.264
74082391|NCT02597049|147717175|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.059|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||Efficacy Estimand||0.0|-1.7|0.059
74082392|NCT02597049|147717175|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.435|TWO_SIDED|95.0|-1.2|0.5|||Mixed Models Analysis|||Efficacy Estimand||0.5|-1.2|0.435
74082393|NCT02597049|147717176|SUPERIORITY||Mean Difference (Final Values)|-24.7|||<|0.001|TWO_SIDED|95.0|-30.8|-18.6|||ANCOVA|||Treatment-regimen Estimand||-18.6|-30.8|< .001
74082394|NCT02597049|147717176|SUPERIORITY||Mean Difference (Final Values)|-19.6|||<|0.001|TWO_SIDED|95.0|-25.7|-13.5||Test was not controlled for type I error.|ANCOVA|||Treatment-regimen Estimand||-13.5|-25.7|<0.001
74082395|NCT02597049|147717176|SUPERIORITY||Mean Difference (Final Values)|-26.6|||<|0.001|TWO_SIDED|95.0|-32.7|-20.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand||-20.6|-32.7|<0.001
74082396|NCT02597049|147717176|SUPERIORITY||Mean Difference (Final Values)|-20.7|||<|0.001|TWO_SIDED|95.0|-26.7|-14.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand||-14.6|-26.7|<0.001
74082397|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-19.7|||<|0.001|TWO_SIDED|95.0|-25.7|-13.8|||Mixed Models Analysis|||Pre-morning meal.||-13.8|-25.7|< .001
74082398|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-21.2|-9.2|||Mixed Models Analysis|||Pre-morning meal||-9.2|-21.2|< .001
74082399|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-24.5|||<|0.001|TWO_SIDED|95.0|-33.8|-15.3|||Mixed Models Analysis|||2-hour postprandial||-15.3|-33.8|< .001
74082400|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-21.1|||<|0.001|TWO_SIDED|95.0|-30.3|-11.8|||Mixed Models Analysis|||2-hour postprandial||-11.8|-30.3|< .001
74082401|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-18.3|||<|0.001|TWO_SIDED|95.0|-26.4|-10.2|||Mixed Models Analysis|||Pre-midday meal||-10.2|-26.4|< .001
74082402|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-14.3|||<|0.001|TWO_SIDED|95.0|-22.5|-6.2|||Mixed Models Analysis|||Pre-midday meal||-6.2|-22.5|< .001
74082403|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-19.0|||<|0.001|TWO_SIDED|95.0|-28.8|-9.3|||Mixed Models Analysis|||2-hour postprandial after midday meal||-9.3|-28.8|< .001
74082404|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-12.8||||0.01|TWO_SIDED|95.0|-22.5|-3.1|||Mixed Models Analysis|||2-hour postprandial after midday meal||-3.1|-22.5|0.010
74082405|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-22.7|||<|0.001|TWO_SIDED|95.0|-30.7|-14.7|||Mixed Models Analysis|||Pre-evening meal||-14.7|-30.7|< .001
74082406|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-22.5|||<|0.001|TWO_SIDED|95.0|-30.7|-14.4|||Mixed Models Analysis|||Pre-evening meal||-14.4|-30.7|< .001
74082407|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-22.1|||<|0.001|TWO_SIDED|95.0|-31.4|-12.9|||Mixed Models Analysis|||2-hour postprandial after evening meal||-12.9|-31.4|< .001
74082408|NCT02597049|147717177|SUPERIORITY||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-26.0|-7.4|||Mixed Models Analysis|||2-hour postprandial after evening meal||-7.4|-26.0|< .001
74082409|NCT02597049|147717178|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.032|TWO_SIDED|95.0|-2.3|-0.1|||ANCOVA|||Treatment-regimen Estimand||-0.1|-2.3|0.032
74082410|NCT02597049|147717178|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.273|TWO_SIDED|95.0|-1.7|0.5|||ANCOVA|||Treatment-regimen Estimand||0.5|-1.7|0.273
74082411|NCT02597049|147717178|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.023|TWO_SIDED|95.0|-2.4|-0.2|||ANCOVA|||Efficacy Estimand||-0.2|-2.4|0.023
74082412|NCT02597049|147717178|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.32|TWO_SIDED|95.0|-1.7|0.6|||ANCOVA|||Efficacy Estimand||0.6|-1.7|0.320
74082413|NCT02463487|147717183|OTHER|||||||0.87|||||||t-test, 1 sided|||||||0.87
74082414|NCT02463487|147717185|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.08
74082415|NCT03105297|147717223|SUPERIORITY|||||||0.0147||95.0||||p-value for comparing between treatments (strip/no strip) were computed from mixed models with treatment \& period as fixed effects, participants as random effects \& time as repeated measures effect.|ANCOVA|||||||0.0147
74082416|NCT03105297|147717224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided|||||||<0.0001
74082417|NCT03105297|147717225|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided|||||||<0.0001
74082418|NCT03105297|147717226|SUPERIORITY_OR_OTHER|||||||0.0073||95.0||||p-values are from a one sample t-test using SAS (Statistical Analysis System) UNIVARIATE on change from baseline.|t-test, 1 sided|||||||0.0073
74082419|NCT01390948|147717249|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.44||||0.1292|TWO_SIDED|95.0|0.9|2.3|||Log Rank|||||2.30|0.90|0.1292
74082420|NCT00556673|147717291|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|||<|0.0001|TWO_SIDED|90.0|0.28|0.51||"Linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.~A significance level of 5% was used to determine statistical significance."|1-sided|||The primary hypothesis tested was that the change from period baseline of trough FEV1 for placebo and indacaterol/mometasone was equal. The one-sided alternative was that the increase from period baseline of trough FEV1 for indacaterol/mometasone was higher than for placebo.||0.51|0.28|< 0.0001
74082421|NCT03555695|147717306|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
74082422|NCT00874276|147717322|SUPERIORITY_OR_OTHER||Kendall's Tau-B|0.6|STANDARD_ERROR_OF_MEAN|0.127||0.023|TWO_SIDED|95.0|0.35|0.85||This is the primary outcome, and there is no adjustment.|Wilcoxon (Mann-Whitney)|||We used a Wilcoxon test (and accompanying Kendal's Tau B) because these outcomes are outlier prone.||0.85|0.35|0.023
74082423|NCT00874276|147717323|SUPERIORITY_OR_OTHER||Kendall's Tau B|-0.23|STANDARD_ERROR_OF_MEAN|0.23||0.42|TWO_SIDED|95.0|-0.23|0.69|||Wilcoxon (Mann-Whitney)|||This is the same analysis as the previous, except we use the day 5 pharmacogenetics on the amount of time needed to clear one-half of dose of the drug. This is for the environmental dose. A positive (negative) Kendall's Tau is associated with the EGT allele being faster (slower) than lacking EGT in terms of metabolization of DCA.||0.69|-0.23|0.42
74082424|NCT00840840|147717324|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|101.45||||||90.0|97.71|105.33|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.33|97.71|
74082425|NCT00840840|147717325|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|103.05||||||90.0|101.25|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.88|101.25|
74082426|NCT00840840|147717326|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.94||||||90.0|101.08|104.83|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.83|101.08|
74082427|NCT00840840|147717327|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|99.68||||||90.0|92.41|107.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.52|92.41|
74082428|NCT00840840|147717328|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|101.48||||||90.0|94.73|108.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.71|94.73|
74082429|NCT00840840|147717329|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|100.17||||||90.0|91.95|109.13|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.13|91.95|
74082430|NCT03969641|147717348|NON_INFERIORITY|This objective will be assessed using a one-sided noninferiority test with the alpha level set at 0.025 (1-sided) and a noninferiority margin of 10%.|Difference in Proportions (RIV4 - IIV4)|-0.0214|||<|0.0001|ONE_SIDED|97.5||0.0406|||Cochran-Mantel-Haenszel|The upper bound of a Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used, stratified by site.|The directional comparison was the upper bound of the confidence interval using a 10% noninferiority margin.|The null hypothesis assumes that RIV4 is inferior (i.e., RIV4 will have a higher proportion) to IIV4 in regards to the proportion of pregnant women with adverse birth outcomes.||0.0406||<0.0001
74082431|NCT03969641|147717349|SUPERIORITY|This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of preterm birth was also calculated.|Odds Ratio (OR)|0.72||||0.4645|TWO_SIDED|95.0|0.35|1.48|||Mantel Haenszel|||Preterm birth||1.48|0.35|0.4645
74082432|NCT03969641|147717350|SUPERIORITY|These proportions were compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportions of combined fetal death and neonatal death was also calculated.|Odds Ratio (OR)|0.00000031||||0.2447|TWO_SIDED|95.0|0.0||The upper limit of this CI is infinity, thus no numeric value can be provided.||Mantel Haenszel|||Fetal or neonatal death|||0.00|0.2447
74082433|NCT03969641|147717351|SUPERIORITY|This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of spontaneous abortion after vaccination was also calculated. This was a subgroup analysis of only those participants vaccinated at less than 20 weeks gestational age.|Odds Ratio (OR)|0.5||||0.6235|TWO_SIDED|95.0|0.04|5.47|||Mantel Haenszel|||Spontaneous abortion||5.47|0.04|0.6235
74082434|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.17||||0.7029|TWO_SIDED|95.0|0.55|2.5|||Mantel Haenszel|||Injection Site Pain||2.50|0.55|0.7029
74082435|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|2.03||||0.6217|TWO_SIDED|95.0|0.18|22.52|||Mantel Haenszel|||Injection Site Redness||22.52|0.18|0.6217
74082436|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.7||||0.3848|TWO_SIDED|95.0|0.35|1.39|||Mantel Haenszel|||Injection Site Tenderness||1.39|0.35|0.3848
74082437|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.53||||0.2504|TWO_SIDED|95.0|0.21|1.35|||Mantel Haenszel|||Nausea||1.35|0.21|0.2504
74082438|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.62||||0.5751|TWO_SIDED|95.0|0.2|1.93|||Mantel Haenszel|||Vomiting||1.93|0.20|0.5751
74082439|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.32|3.19|||Mantel Haenszel|||Diarrhea||3.19|0.32|1.0000
74082440|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.8||||1|TWO_SIDED|95.0|0.21|3.04|||Mantel Haenszel|||Abdominal Pain||3.04|0.21|1.0000
74082441|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.53||||0.1326|TWO_SIDED|95.0|0.25|1.13|||Mantel Haenszel|||Headache||1.13|0.25|0.1326
74082442|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.2|5.04|||Mantel Haenszel|||Chills/Shivering||5.04|0.20|1.0000
74082443|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0||The upper limit of this CI is infinity, thus no numeric value can be provided.||Mantel Haenszel|||Body Rash|||0.00|1.0000
74082444|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.92||||1|TWO_SIDED|95.0|0.39|2.15|||Mantel Haenszel|||Malaise (Fatigue)||2.15|0.39|1.0000
74082445|NCT03969641|147717352|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.87||||1|TWO_SIDED|95.0|0.31|2.48|||Mantel Haenszel|||Myalgia (Body Aches)||2.48|0.31|1.0000
74082446|NCT03969641|147717352|SUPERIORITY||Odds Ratio (OR)|0.71||||0.7704|TWO_SIDED|95.0|0.22|2.29|||Mantel Haenszel|||Joint Pain||2.29|0.22|0.7704
74082447|NCT00354835|147717360|SUPERIORITY_OR_OTHER_LEGACY||The incidence of anemia|0.2613|||||ONE_SIDED|95.0||0.31||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. Comparing the incidence of anemia with VAC on ARST0531 to the historical rate of 0.40 with VAC on D9803. The 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.||0.31||
74082448|NCT00354835|147717360|SUPERIORITY_OR_OTHER_LEGACY||The incidence of nausea or hepatopathy|0.027|||||ONE_SIDED|95.0||0.0449||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.||0.0449||
74082449|NCT00354835|147717360|SUPERIORITY_OR_OTHER_LEGACY||The incidence of febrile neutropenia|0.1351|||||ONE_SIDED|95.0||0.1729||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.||0.1729||
74082450|NCT00354835|147717360|SUPERIORITY_OR_OTHER_LEGACY||The incidence of platelet count decrease|0.1216|||||ONE_SIDED|95.0||0.1577||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.||0.1577||
74082451|NCT00354835|147717360|SUPERIORITY_OR_OTHER_LEGACY||The incidence of vomiting|0.0405|||||ONE_SIDED|95.0||0.0623||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.||0.0623||
74082452|NCT00354835|147717360|SUPERIORITY_OR_OTHER_LEGACY||The incidence of anemia|0.2798|||||ONE_SIDED|95.0||0.3329||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.||0.3329||
74082453|NCT00354835|147717360|SUPERIORITY_OR_OTHER_LEGACY||The incidence of nausea or hepatopathy|0.0052|||||ONE_SIDED|95.0||0.0137||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.||0.0137||
74082454|NCT00354835|147717360|SUPERIORITY_OR_OTHER_LEGACY||The incidence of febrile neutropenia|0.0881|||||ONE_SIDED|95.0||0.1216||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.||0.1216||
74082455|NCT00354835|147717360|SUPERIORITY_OR_OTHER_LEGACY||The incidence of platelet count decrease|0.3264|||||ONE_SIDED|95.0||0.3819||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.||0.3819||
74082456|NCT00354835|147717360|SUPERIORITY_OR_OTHER_LEGACY||The incidence of vomiting|0.0104|||||ONE_SIDED|95.0||0.0224||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.||0.0224||
74082457|NCT00354835|147717363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|TWO_SIDED|95.0|||||Fisher Exact|||The incidences of grade 3 or higher neutropenia, with or without fever between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by the Fisher's exact test.||||0.99
74082458|NCT00354835|147717363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED|95.0|||||Fisher Exact|||The incidences of grade 3 or higher diarrhea between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by Fisher's exact test.||||0.036
74082459|NCT02670551|147717385|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.0331|TWO_SIDED|95.0|-4.6|-0.4||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.4|-4.6|0.0331
74088219|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.14|<.0001
74082460|NCT02670551|147717385|SUPERIORITY||Least Squares Mean Difference|-3.0||||0.0103|TWO_SIDED|95.0|-5.1|-0.9||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.9|-5.1|0.0103
74082461|NCT02670551|147717386|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.0714|TWO_SIDED|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||0.0|-0.5|0.0714
74082462|NCT02670551|147717386|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.0662|TWO_SIDED|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.0|-0.5|0.0662
74082463|NCT04476277|147717395|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74082464|NCT04476277|147717397|OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
74082465|NCT04476277|147717398|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
74082466|NCT04476277|147717399|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
74082467|NCT04476277|147717400|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
74082468|NCT04476277|147717401|OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
74082469|NCT04476277|147717402|OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
74082470|NCT04476277|147717403|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
74082471|NCT04476277|147717404|OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
74082472|NCT04476277|147717405|OTHER|||||||0.43|||||||t-test, 2 sided|||||||0.43
74082473|NCT04476277|147717406|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
74082474|NCT04476277|147717407|OTHER|||||||0.01|||||||t-test, 1 sided|||||||0.01
74082475|NCT04476277|147717408|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
74082476|NCT01874535|147717433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.009|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
74082477|NCT03790137|147717468|OTHER|The frequency of HWE for each patient was reported as episodes/day, as determined by dividing the total number of seizures experienced over a given time period by the number of days for which seizures were recorded. Paired t-tests were performed to compare each patient's baseline seizure frequency to their seizure frequency in the last month of treatment. Change in seizure frequency is reported as percent change from baseline. An alpha of 0.05 was used for statistical significance.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
74082478|NCT00714051|147717481|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Chi-squared|||The number of participants who fell on the tripping trial in each group were compared using Chi-square analysis||||0.45
74082479|NCT03868631|147717494|SUPERIORITY||||||<|0.05|||||||multilevel models for change|||Between-group differences at baseline were compared using independent t-tests. Multilevel models for change (MLM) were used to determine differences between groups over time for study outcomes. Age, sex, and number of sessions missed were included as covariates. Time and time by group interactions were examined. Analyses were conducted using IBM SPSS Statistics version 23. Significance was set at p\<0.05.||||<0.05
74082480|NCT01929681|147717501|SUPERIORITY||||||<|0.049|||||||Regression, Linear|||||||<0.049
74082481|NCT01929681|147717502|SUPERIORITY||||||<|0.182|||||||Regression, Linear|||||||<0.182
74082482|NCT01929681|147717503|SUPERIORITY||||||<|0.449|||||||Regression, Linear|Mixed effects analysis||||||<0.449
74082483|NCT01929681|147717504|SUPERIORITY||||||<|0.444|||||||Regression, Linear|Mixed effects analysis||||||<0.444
74082484|NCT01929681|147717505|SUPERIORITY||||||<|0.182|||||||Regression, Linear|Mixed effects analysis||||||<0.182
74082485|NCT02452463|147717511|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|||||||0.107
74082486|NCT02452463|147717513|SUPERIORITY|||||||0.75|||||||Log Rank|||Null Hypotheses: OS distributions are equal||||0.75
74082487|NCT02452463|147717514|SUPERIORITY|||||||0.25|||||||Log Rank|||Null Hypotheses: PFS distributions are equal||||0.25
74082488|NCT02452463|147717515|SUPERIORITY|||||||0.131|||||||t-test, 2 sided|||||||0.131
74082489|NCT02452463|147717516|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|||||||0.073
74082490|NCT02452463|147717517|SUPERIORITY|||||||0.616|||||||t-test, 2 sided|||||||0.616
74082491|NCT02452463|147717517|SUPERIORITY|||||||0.183|||||||Paired T-test|||Comparing change relative to baseline.||||0.183
74082492|NCT02452463|147717517|SUPERIORITY|||||||0.203|||||||paired T-test|||Evaluating change relative to baseline.||||0.203
74082493|NCT02452463|147717518|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.00
74082494|NCT05740098|147717520|SUPERIORITY||Odds Ratio (OR)|5.378|||<|0.001|TWO_SIDED|95.0|2.278|12.689|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||12.689|2.278|<0.001
74082495|NCT05740098|147717520|SUPERIORITY||Odds Ratio (OR)|3.668||||0.003|TWO_SIDED|95.0|1.538|8.747|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||8.747|1.538|0.003
74082496|NCT05740098|147717520|SUPERIORITY||Odds Ratio (OR)|0.682||||0.256|TWO_SIDED|95.0|0.352|1.321|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||1.321|0.352|0.256
74082497|NCT05740098|147717520|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Analysis tested for significant main effect of time on 7-day point prevalence abstinence at 12- and 24-week assessments||||<0.001
74082498|NCT05740098|147717521|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.365||0.287|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.287
74082499|NCT05740098|147717521|SUPERIORITY||Mean Difference (Final Values)|-0.597|STANDARD_ERROR_OF_MEAN|0.369||0.108|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.108
74082500|NCT05740098|147717521|SUPERIORITY||Mean Difference (Final Values)|-0.987|STANDARD_ERROR_OF_MEAN|0.361||0.007|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.007
74082501|NCT05740098|147717521|SUPERIORITY|||||||0.878|||||||Mixed Models Analysis|||Analysis tested for significant main effect of time on Child Urine Cotinine||||0.878
74082502|NCT05740098|147717522|SUPERIORITY||Chi-Square Test Statistic|6.909||||0.009|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.009
74082503|NCT05740098|147717522|SUPERIORITY||Chi-Square Test Statistic|4.287||||0.038|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.038
74082504|NCT05740098|147717522|SUPERIORITY||Chi-Square Test Statistic|0.392||||0.531|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.531
74082505|NCT05740098|147717523|SUPERIORITY||Chi-Square Test Statistic|3.859||||0.145|TWO_SIDED||||||Chi-squared|Degrees of freedom = 2||Analysis tested for significant main effect of treatment condition on 7-day point prevalence abstinence at 48-week follow-up||||0.145
74082506|NCT05740098|147717524|SUPERIORITY||Wald Chi-Square Test Statistic|1.454||||0.228|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 6-weeks following quit date adjusting for treatment condition.||||0.228
74082507|NCT05740098|147717524|SUPERIORITY||Wald Chi-Square Test Statistic|2.7||||0.1|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 12-weeks following quit date adjusting for treatment condition.||||0.10
74082508|NCT05740098|147717524|SUPERIORITY||Wald Chi-Square Test Statistic|3.202||||0.074|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 24-weeks following quit date adjusting for treatment condition.||||0.074
74082509|NCT05740098|147717524|SUPERIORITY||Wald Chi-Square Test Statistic|0.491||||0.484|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 48-weeks following quit date adjusting for treatment condition.||||0.484
74082510|NCT05740098|147717525|SUPERIORITY||Wald Chi-Square Test Statistic|1.063||||0.302|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 6-weeks following quit date||||0.302
74082511|NCT05740098|147717525|SUPERIORITY||Wald Chi-Square Test Statistic|0.788||||0.375|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 12-weeks following quit date||||0.375
74082512|NCT05740098|147717525|SUPERIORITY||Wald Chi-Square Test Statistic|0.08||||0.777|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 24-weeks following quit date||||0.777
74082513|NCT05740098|147717525|SUPERIORITY||Wald Chi-Square Test Statistic|0.006||||0.937|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 48-weeks following quit date||||0.937
74082514|NCT05740098|147717525|SUPERIORITY||Wald Chi-Square Test Statistic|0.172||||0.678|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 6-weeks following quit date||||0.678
74082515|NCT05740098|147717525|SUPERIORITY||Wald Chi-Square Test Statistic|7.99||||0.018|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant interaction between baseline price sensitivity (latent factor Persistence) and treatment condition for 6-week abstinence outcome||||0.018
74082516|NCT05740098|147717525|SUPERIORITY||Wald Chi-Square Test Statistic|0.177||||0.674|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 12-weeks following quit date||||0.674
74082517|NCT05740098|147717525|SUPERIORITY||Wald Chi-Square Test Statistic|0.646||||0.422|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 24-weeks following quit date||||0.422
74082518|NCT05740098|147717525|SUPERIORITY||Wald Chi-Square Test Statistic|0.038||||0.846|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 48-weeks following quit date||||0.846
74082519|NCT01073631|147717530|SUPERIORITY_OR_OTHER||Efficacy rate (percent)|78.9|||||TWO_SIDED|95.0|75.07|82.73|||Normal approximation to binomial||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement||82.73|75.07|
74082520|NCT01426854|147717581|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
74082521|NCT01971554|147717583|SUPERIORITY_OR_OTHER||Difference in the least squares means|30.8|||||TWO_SIDED|90.0|11.3|50.3|||||A constrained longitudinal data analysis (cLDA) model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||50.3|11.3|
74082522|NCT01971554|147717583|SUPERIORITY_OR_OTHER||Difference in the least squares means|36.0|||||TWO_SIDED|90.0|20.0|51.9|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||51.9|20.0|
74082523|NCT01971554|147717583|SUPERIORITY_OR_OTHER||Difference in the least squares means|54.1|||||TWO_SIDED|90.0|38.1|70.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||70.0|38.1|
74082524|NCT01971554|147717589|SUPERIORITY_OR_OTHER||Difference in the least squares means|22.3|||||TWO_SIDED|90.0|6.2|38.4|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||38.4|6.2|
74082525|NCT01971554|147717589|SUPERIORITY_OR_OTHER||Difference in the least squares means|30.6|||||TWO_SIDED|90.0|17.4|43.8|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||43.8|17.4|
74082526|NCT01971554|147717589|SUPERIORITY_OR_OTHER||Difference in the least squares means|48.8|||||TWO_SIDED|90.0|35.6|62.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||62.0|35.6|
74082527|NCT03505151|147717597|OTHER||Ratio T/R|44.63|STANDARD_ERROR_OF_MEAN|36.9||||90.0|32.62|61.06|||||Standard Error of the mean is actually Intra-individual geometric coefficient of variation (gCV) of the mean|Absolute bioavailability was evaluated using an Analysis of variance model (ANOVA) on BI 409306 AUC0-inf versus 0.1 mg BI 409306 C-13/N-15 i.v. This model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. The dose normalised PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model.||61.06|32.62|
74022041|NCT01252966|147596696|SUPERIORITY_OR_OTHER|||||||0.033||||||Results would not survive correction for multiple hypothesis testing.|Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.033
74022042|NCT03275870|147596706|OTHER|||||||0.042||||||p value \<0.05 used as threshold for significance|t-test, 2 sided|||||||0.042
74022043|NCT03275870|147596707|OTHER|||||||0.213||||||P value of \<0.05 used as threshold for significance|t-test, 2 sided|||||||0.213
74022044|NCT01903876|147596713|NON_INFERIORITY_OR_EQUIVALENCE|equivalence||||||0.044|||||||ANCOVA|||||||.044
74022045|NCT01903876|147596714|NON_INFERIORITY_OR_EQUIVALENCE|equivalence||||||0.042|||||||ANCOVA|||||||.042
74022046|NCT02811744|147596717|EQUIVALENCE|Equivalence was defined as no significant difference between study groups on a T-test.||||||0.5||||||No adjustments on the comparison. There was no multiple comparison adjustment for the p value, as this was the primary outcome. This is the experimental p value; the threshold for significance was 0.05.|t-test, 2 sided|||No power calculation. This is an exploratory study.||||0.5
74022047|NCT03902080|147596751|SUPERIORITY||Least square mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|-1.02|-0.46|||Mixed Models Analysis|||||-0.46|-1.02|<0.0001
74022048|NCT03902080|147596752|SUPERIORITY||Least Squares Means Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.211|<|0.0001|TWO_SIDED|95.0|-1.37|-0.54|||Mixed Models Analysis|||||-0.54|-1.37|<0.0001
74022049|NCT03902080|147596753|SUPERIORITY||Least Squares Means Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07|=|0.0015|TWO_SIDED|95.0|-0.36|-0.09|||Mixed Models Analysis|||||-0.09|-0.36|=0.0015
74022050|NCT03902080|147596754|SUPERIORITY||Least Squares Means Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.269|=|0.0034|TWO_SIDED|95.0|-1.33|-0.27|||Mixed Models Analysis|||||-0.27|-1.33|=0.0034
74022051|NCT03902080|147596755|SUPERIORITY||Least Squares Means Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Models Analysis|||||-0.5|-1.2|<0.0001
74022052|NCT03902080|147596756|SUPERIORITY||Least Squares Means Difference|15.07|STANDARD_ERROR_OF_MEAN|3.03|<|0.0001|TWO_SIDED|95.0|9.13|21.02|||Mixed Models Analysis|||||21.02|9.13|<0.0001
74022053|NCT03093402|147596771|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Median Difference (Final Values)|-0.9||||0.419|TWO_SIDED|95.0|-2.5|0.6||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for High JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.6|-2.5|0.4190
74022054|NCT03093402|147596771|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Median Difference (Final Values)|-1.2||||0.419|TWO_SIDED|95.0|-2.7|0.3||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for Medium JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.3|-2.7|0.4190
74029773|NCT03151148|147614041|SUPERIORITY||Geometric mean ratio (GMR)|2.722||||0.432|TWO_SIDED|95.0|0.2227|33.2594|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||33.2594|0.2227|0.432
74082528|NCT03505151|147717598|OTHER||Ratio T/R|47.25|STANDARD_ERROR_OF_MEAN|68.8||||90.0|27.38|81.55|||||Standard Error of the mean is actually Intra-individual geometric coefficient of variation (gCV) of the mean|Ratios of BI 409306 for Cmax versus 0.1 mg BI 409306 C-13/N-15 i.v. was evaluated using ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. The dose normalised PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model.||81.55|27.38|
74082529|NCT01942135|147717604|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.422|||<|1e-06|TWO_SIDED|95.0|0.318|0.56||The overall Type-I error rate was persevered at 1-sided 0.025 level for the analysis of the primary endpoint PFS by the Haybittle-Peto efficacy boundary. The priori threshold for statistical significance was 0.00135.|Stratified Log Rank Test (1-sided)|The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ\<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.||0.560|0.318|<0.000001
74082530|NCT01942135|147717606|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.814|||=|0.0429|TWO_SIDED|95.0|0.644|1.029||1-sided p-value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior endocrine therapy per randomization.|Stratified Log Rank Test (1-sided)|The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of palbociclib plus fulvestrant.|The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ\<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.||1.029|0.644|=0.0429
74082531|NCT01942135|147717608|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.783||||0.0001|TWO_SIDED|95.0|1.563|5.603||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An Odds Ratio \>1 means better response in favor of the palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio \>1 means better response in favor of palbociclib plus fulvestrant arm.||5.603|1.563|0.0001
74082532|NCT01942135|147717610|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.016|||<|0.0001|TWO_SIDED|95.0|2.046|4.565||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An odds ratio \> 1 means better clinical benefit response in favor of palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio \>1 means better response in favor of palbociclib plus fulvestrant arm.||4.565|2.046|<0.0001
74082533|NCT01942135|147717614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1||||0.0313|TWO_SIDED|95.0|0.3|6.0||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for Global health status/ QoL||6.0|0.3|0.0313
74082534|NCT01942135|147717614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.4|TWO_SIDED|95.0|-1.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for physical functioning||3.5|-1.4|0.4000
74082535|NCT01942135|147717614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9||||0.2615|TWO_SIDED|95.0|-1.5|5.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for role functioning||5.3|-1.5|0.2615
74082536|NCT01942135|147717614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6||||0.0016|TWO_SIDED|95.0|1.7|7.4||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for emotional functioning||7.4|1.7|0.0016
74082537|NCT01942135|147717614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.365|TWO_SIDED|95.0|-1.4|3.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for cognitive functioning||3.8|-1.4|0.3650
73836856|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|2.3|||||TWO_SIDED|95.0|0.56|9.06||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||9.06|0.56|
74082538|NCT01942135|147717614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9615|TWO_SIDED|95.0|-3.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for social functioning||3.5|-3.4|0.9615
74082539|NCT01942135|147717615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.32|TWO_SIDED|95.0|-4.5|1.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for fatigue||1.5|-4.5|0.3200
74082540|NCT01942135|147717615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||0.0369|TWO_SIDED|95.0|-4.8|-0.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for nausea and vomiting||-0.2|-4.8|0.0369
74082541|NCT01942135|147717615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3||||0.0011|TWO_SIDED|95.0|-8.5|-2.1||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for pain||-2.1|-8.5|0.0011
74082542|NCT01942135|147717615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.7699|TWO_SIDED|95.0|-3.7|2.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for dyspnoea||2.8|-3.7|0.7699
74082543|NCT01942135|147717615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.2721|TWO_SIDED|95.0|-5.5|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for insomnia||1.6|-5.5|0.2721
74082544|NCT01942135|147717615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.7334|TWO_SIDED|95.0|-4.1|2.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for appetite loss||2.9|-4.1|0.7334
74082545|NCT01942135|147717615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.6491|TWO_SIDED|95.0|-2.5|3.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for constipation||3.9|-2.5|0.6491
74082546|NCT01942135|147717615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.6293|TWO_SIDED|95.0|-2.8|1.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for diarrhoea||1.7|-2.8|0.6293
74082547|NCT01942135|147717615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.8812|TWO_SIDED|95.0|-3.1|3.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for financial difficulties||3.6|-3.1|0.8812
74082548|NCT01942135|147717616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.1386|TWO_SIDED|95.0|-0.7|5.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for body image||5.2|-0.7|0.1386
74082549|NCT01942135|147717616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.5235|TWO_SIDED|95.0|-3.1|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual functioning||1.6|-3.1|0.5235
74082550|NCT01942135|147717616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.6271|TWO_SIDED|95.0|-4.4|7.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual enjoyment||7.3|-4.4|0.6271
74082551|NCT01942135|147717616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.6||||0.0845|TWO_SIDED|95.0|-0.5|7.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for future perspective||7.6|-0.5|0.0845
74082552|NCT01942135|147717617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.7273|TWO_SIDED|95.0|-1.6|2.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for systemic therapy side effects||2.3|-1.6|0.7273
74082553|NCT01942135|147717617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.2671|TWO_SIDED|95.0|-2.6|0.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for breast symptoms||0.7|-2.6|0.2671
74082554|NCT01942135|147717617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.875|TWO_SIDED|95.0|-2.6|2.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for arm symptoms||2.2|-2.6|0.8750
74082555|NCT01942135|147717617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.9||||0.0255|TWO_SIDED|95.0|1.1|16.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for upset by hair loss||16.6|1.1|0.0255
74082556|NCT01942135|147717618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.037||||0.0308|TWO_SIDED|95.0|0.0|0.07||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.07|0.00|0.0308
74082557|NCT01942135|147717619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.5523|TWO_SIDED|95.0|-1.9|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||3.5|-1.9|0.5523
73836857|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.1|||||TWO_SIDED|95.0|0.02|0.78||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.78|0.02|
74082558|NCT01942135|147717620|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.642|||<|0.001|TWO_SIDED|95.0|0.487|0.846||The priori threshold for statistical significance is 1-sided alpha=0.025. The p-value was not adjusted for multiple comparisons.|Unstratified log-rank test (1-sided)|1-sided p-value from the unstratified log-rank test.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|Treatment with palbociclib plus fulvestrant significantly delayed TTD in pain symptom compared with placebo plus fulvestrant for unstratified analysis.||0.846|0.487|<0.001
74082559|NCT00950300|147717624|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the 90% confidence interval (CI) was greater than or equal to (≥) 0.8 for the geometric mean ratio.|Geometric mean ratio|1.33|||||TWO_SIDED|90.0|1.24|1.44|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|PK sample size calculations based on percentage of coefficient of variation (CV%) for Ctrough of trastuzumab from previous metastatic breast cancer (MBC) and early breast cancer (EBC) studies. Because pre-surgery situation was comparable to MBC setting, interpatient CV% of 60 percent (%) was assumed and 130 participants per arm (260 participants total) were needed to demonstrate Ctrough comparability with 80% power if the true means of the two formulations did not differ by greater than (\>) 5%.||1.44|1.24|
74082560|NCT00950300|147717625|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the one-sided 97.5% CI was above -12.5% for the difference in response (pCR) rates.|Difference in response rates|4.7|||||ONE_SIDED|97.5|-4.0||||||The one-sided 97.5% CI for the difference in response (pCR) rates was calculated using the Anderson-Hauck continuity correction.|Assuming pCR rates of at least 40% in both arms, 552 participants were necessary to conclude non-inferiority in pCR rate with a power of 80% using a one-sided 97.5% CI for the difference of the response rates and a non-inferiority margin of 12.5%.|||-4.0|
74082561|NCT00950300|147717626|OTHER||Geometric mean ratio|1.51|||||TWO_SIDED|90.0|1.4|1.63|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.63|1.40|
74082562|NCT00950300|147717627|OTHER||Geometric mean ratio|1.55|||||TWO_SIDED|90.0|1.46|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.64|1.46|
74082563|NCT00950300|147717628|OTHER||Geometric mean ratio|1.55|||||TWO_SIDED|90.0|1.45|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.64|1.45|
74082564|NCT00950300|147717637|OTHER||Difference in response rates|5.01|||||TWO_SIDED|95.0|-3.5|13.5|||||The 95% CI for the difference in response (tpCR) rates was calculated using the Anderson-Hauck continuity correction.|||13.5|-3.5|
74082565|NCT00950300|147717638|OTHER||Difference in response rates|-1.64|||||TWO_SIDED|95.0|-7.4|4.2|||||The 95% CI for the difference in response (CR+PR) rates was calculated using the Anderson-Hauck continuity correction.|||4.2|-7.4|
74082566|NCT00950300|147717638|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.5|1.46|||||OR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.46|0.50|
74082567|NCT00950300|147717641|OTHER||Hazard Ratio (HR)|0.98||||0.8651|TWO_SIDED|95.0|0.74|1.29|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.29|0.74|0.8651
74082568|NCT00950300|147717643|OTHER||Hazard Ratio (HR)|0.94||||0.7767|TWO_SIDED|95.0|0.61|1.45|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.45|0.61|0.7767
74082569|NCT00494013|147717647|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was 0.4%.|Mean Difference (Net)|-0.21||||0.026||95.0|-0.39|-0.03|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin determir, injected once or twice daily, with regard to glycemic control as measured by change in HbA1c from baseline to endpoint (last observation carried forward).||-0.03|-0.39|0.026
74082570|NCT00494013|147717648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||0.06|-0.28|0.213
74082571|NCT00494013|147717648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||0.06|-0.28|0.213
74082572|NCT00494013|147717648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||-0.01|-0.38|0.038
74082573|NCT00494013|147717648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||-0.01|-0.38|0.038
74082574|NCT00494013|147717649|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-value for HbA1c \<7.0%.|Fisher Exact|||||||0.463
74082575|NCT00494013|147717649|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for HbA1c ≤6.5%.|Fisher Exact|||||||0.135
74082576|NCT00494013|147717650|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.8 millimoles per Liter (mmol/L).|Mean Difference (Net)|0.1||||0.107||95.0|-0.02|0.23|||ANOVA|ANOVA model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The first gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to determir.||0.23|-0.02|0.107
74082577|NCT00494013|147717651|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||P-value for Average 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.952
74082578|NCT00494013|147717651|SUPERIORITY_OR_OTHER|||||||0.856||95.0||||P-value for Average Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.856
74082579|NCT00494013|147717651|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value for Average Post-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.790
74082580|NCT00494013|147717651|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||P-value for Average Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.632
74082581|NCT00494013|147717652|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value for All Hypoglycemic Events.|Fisher Exact|||||||0.472
74082582|NCT00494013|147717652|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Nocturnal Hypoglycemic Events.|Fisher Exact|||||||0.005
74082583|NCT00494013|147717652|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P-value for Severe Hypoglycemic Events.|Fisher Exact|||||||0.450
74082584|NCT00494013|147717653|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.001
74082585|NCT00494013|147717653|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.001
74082586|NCT00494013|147717653|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.226
74082587|NCT00494013|147717655|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|1.5|||<|0.001||95.0|0.93|2.06||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The second gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to detemir with regard to change in absolute body weight from baseline to endpoint (last observation carried forward).||2.06|0.93|<0.001
74082588|NCT00494013|147717656|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.074
74082589|NCT00494013|147717657|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.039
74082590|NCT00494013|147717658|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Fisher Exact|||||||0.026
74082591|NCT02286466|147717684|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.38||0.412|TWO_SIDED|95.0|-1.6|3.87||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcomes and psychotropic medication use||Analysis comparing the change in anxiety symptoms (HAM-A) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||3.87|-1.60|0.412
74082592|NCT02286466|147717685|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|2.51||0.997|TWO_SIDED|95.0|-4.99|4.96||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in quality of life (FACT-G) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use||4.96|-4.99|0.997
74082593|NCT02286466|147717686|SUPERIORITY||Mean Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|0.63||0.215|TWO_SIDED|95.0|-0.46|2.02||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report anxiety symptoms on the HADS-Anxiety Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||2.02|-0.46|0.215
74082594|NCT02286466|147717686|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.55||0.379|TWO_SIDED|95.0|-0.6|1.57||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report depression symptoms on the HADS-Depression Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||1.57|-0.60|0.379
74082595|NCT02286466|147717687|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.81||0.852|TWO_SIDED|95.0|-1.45|1.75||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in depression symptoms on the PHQ-9 from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||1.75|-1.45|0.852
74082596|NCT00835081|147717688|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|95.9|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||110|95.9|
74082597|NCT00835081|147717689|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.5|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||103|97.5|
74082598|NCT00835081|147717690|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|97.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||102|97.4|
74082599|NCT00421304|147717691|SUPERIORITY|||||||0.218|||||||Wilcoxon's rank-sum test|||||||0.218
74082600|NCT00421304|147717691|SUPERIORITY|||||||0.643|||||||Wilcoxon's rank-sum test|||||||0.643
74082601|NCT00421304|147717691|SUPERIORITY|||||||0.677|||||||Wilcoxon's rank-sum test|||||||0.677
74082602|NCT00421304|147717692|SUPERIORITY|||||||0.257|||||||Wilcoxon's rank-sum test|||||||0.257
74082603|NCT00421304|147717692|SUPERIORITY|||||||0.726|||||||Wilcoxon's rank-sum test|||||||0.726
74082604|NCT00421304|147717692|SUPERIORITY|||||||0.551|||||||Wilcoxon's rank-sum test|||||||0.551
74082605|NCT00421304|147717693|SUPERIORITY|||||||0.591|||||||Wilcoxon's rank-sum test|||||||0.591
74082606|NCT00421304|147717693|SUPERIORITY|||||||0.393|||||||Wilcoxon's rank-sum test|||||||0.393
74082607|NCT00421304|147717693|SUPERIORITY|||||||0.586|||||||Wilcoxon's rank-sum test|||||||0.586
74082608|NCT00421304|147717694|SUPERIORITY|||||||0.894|||||||Wilcoxon's rank-sum test|||||||0.894
74082609|NCT00421304|147717694|SUPERIORITY|||||||0.674|||||||Wilcoxon's rank-sum test|||||||0.674
74082610|NCT00421304|147717694|SUPERIORITY|||||||0.636|||||||Wilcoxon's rank-sum test|||||||0.636
74082611|NCT00421304|147717695|SUPERIORITY|||||||0.397|||||||Wilcoxon's rank-sum test|||||||0.397
74082612|NCT00421304|147717695|SUPERIORITY|||||||0.238|||||||Wilcoxon's rank-sum test|||||||0.238
74082613|NCT00421304|147717695|SUPERIORITY|||||||0.461|||||||Wilcoxon's rank-sum test|||||||0.461
74082614|NCT00421304|147717696|SUPERIORITY|||||||0.322|||||||Wilcoxon's rank-sum test|||||||0.322
74082615|NCT00421304|147717696|SUPERIORITY|||||||0.747|||||||Wilcoxon's rank-sum test|||||||0.747
74082616|NCT00421304|147717696|SUPERIORITY|||||||0.717|||||||Wilcoxon's rank-sum test|||||||0.717
74082617|NCT00421304|147717697|SUPERIORITY|||||||0.847|||||||Wilcoxon's rank-sum test|||||||0.847
74082618|NCT00421304|147717697|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
74082619|NCT00421304|147717697|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
74082620|NCT00421304|147717698|SUPERIORITY|||||||0.653|||||||Wilcoxon's rank-sum test|||||||0.653
74082621|NCT00421304|147717698|SUPERIORITY|||||||0.283|||||||Wilcoxon's rank-sum test|||||||0.283
74082622|NCT00421304|147717698|SUPERIORITY|||||||0.411|||||||Wilcoxon's rank-sum test|||||||0.411
74082623|NCT00421304|147717699|SUPERIORITY|||||||0.988|||||||Wilcoxon's rank-sum test|||||||0.988
74082624|NCT00421304|147717699|SUPERIORITY|||||||0.832|||||||Wilcoxon's rank-sum test|||||||0.832
74082625|NCT00421304|147717699|SUPERIORITY|||||||0.748|||||||Wilcoxon's rank-sum test|||||||0.748
74082626|NCT00421304|147717700|SUPERIORITY|||||||0.28|||||||Wilcoxon's rank-sum test|||||||0.280
74082627|NCT00421304|147717700|SUPERIORITY|||||||0.108|||||||Wilcoxon's rank-sum test|||||||0.108
74082628|NCT00421304|147717700|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
74082629|NCT00421304|147717701|SUPERIORITY|||||||0.742|||||||Wilcoxon's rank-sum test|||||||0.742
74082630|NCT00421304|147717701|SUPERIORITY|||||||0.486|||||||Wilcoxon's rank-sum test|||||||0.486
74082631|NCT00421304|147717701|SUPERIORITY|||||||0.49|||||||Wilcoxon's rank-sum test|||||||0.490
74082632|NCT00421304|147717702|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
74082633|NCT00421304|147717703|SUPERIORITY|||||||0.05|||||||Wilcoxon's rank-sum test|||||||0.050
74082634|NCT00421304|147717704|SUPERIORITY|||||||0.008|||||||Wilcoxon's rank-sum test|||||||0.008
74082635|NCT00421304|147717705|SUPERIORITY|||||||0.012|||||||Wilcoxon's rank-sum test|||||||0.012
74082636|NCT00421304|147717706|SUPERIORITY||||||<|0.001|||||||Wilcoxon's rank-sum test|||||||<0.001
74082637|NCT01139762|147717756|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.41||||0.001|TWO_SIDED|95.0|-2.27|-0.55|||Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.55|-2.27|0.001
74082638|NCT01139762|147717758|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51||||0.007|TWO_SIDED|95.0|-0.87|-0.14||P-value is for IPSS storage (irritative) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-0.87|0.007
74082639|NCT01139762|147717758|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.04|TWO_SIDED|95.0|-0.8|-0.02||P-value is for IPSS storage (irritative) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.02|-0.80|0.040
74082640|NCT01139762|147717758|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.107|TWO_SIDED|95.0|-0.75|0.07||P-value is for IPSS storage (irritative) subscore - 26 weeks|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.07|-0.75|0.107
74082641|NCT01139762|147717758|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.69|-0.68||P-value is for IPSS voiding (obstructive) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.68|-1.69|<0.001
74082642|NCT01139762|147717758|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.62|-0.46||P-value is for IPSS voiding (obstructive) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.46|-1.62|<0.001
74082643|NCT01139762|147717758|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73||||0.015|TWO_SIDED|95.0|-1.32|-0.14||P-value is IPSS voiding (obstructive) subscore - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-1.32|0.015
74082644|NCT01139762|147717759|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.5|-0.14||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-0.50|<0.001
74082645|NCT01139762|147717759|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.051|TWO_SIDED|95.0|-0.38|0.0||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.00|-0.38|0.051
74082646|NCT01139762|147717759|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.107|TWO_SIDED|95.0|-0.38|0.04||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.04|-0.38|0.107
74082647|NCT01139762|147717760|SUPERIORITY_OR_OTHER||LS Mean Difference|4.85|||<|0.001|TWO_SIDED|95.0|3.49|6.21||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||6.21|3.49|<0.001
74082648|NCT01139762|147717760|SUPERIORITY_OR_OTHER||LS Mean Difference|4.08|||<|0.001|TWO_SIDED|95.0|2.55|5.6||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||5.60|2.55|<0.001
74082649|NCT01139762|147717760|SUPERIORITY_OR_OTHER||LS Mean Difference|4.73|||<|0.001|TWO_SIDED|95.0|3.15|6.31||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||6.31|3.15|<0.001
74082650|NCT01139762|147717761|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|||<|0.001|TWO_SIDED|95.0|0.61|1.4||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.40|0.61|<0.001
74082651|NCT01139762|147717761|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06|||<|0.001|TWO_SIDED|95.0|0.61|1.51||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.51|0.61|<0.001
74082652|NCT01139762|147717761|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|||<|0.001|TWO_SIDED|95.0|0.74|1.69||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.69|0.74|<0.001
74082653|NCT01139762|147717762|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|||<|0.001|TWO_SIDED|95.0|1.18|2.47||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.47|1.18|<0.001
74082654|NCT01139762|147717762|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|||<|0.001|TWO_SIDED|95.0|0.88|2.31||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.31|0.88|<0.001
74082655|NCT01139762|147717762|SUPERIORITY_OR_OTHER||LS Mean Difference|1.98|||<|0.001|TWO_SIDED|95.0|1.23|2.73||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.73|1.23|<0.001
74082656|NCT01139762|147717763|SUPERIORITY_OR_OTHER||LS Mean Difference|1.53|||<|0.001|TWO_SIDED|95.0|0.92|2.13||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.13|0.92|<0.001
74082657|NCT01139762|147717763|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.006|TWO_SIDED|95.0|0.27|1.54||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.54|0.27|0.006
74082658|NCT01139762|147717763|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.002|TWO_SIDED|95.0|0.41|1.74||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.74|0.41|0.002
74082659|NCT01139762|147717764|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|||<|0.001|TWO_SIDED|95.0|0.61|1.25||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.25|0.61|<0.001
73836858|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.22|7.07||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||7.07|0.22|
74082660|NCT01139762|147717764|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|||<|0.001|TWO_SIDED|95.0|0.44|1.14||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.14|0.44|<0.001
74022055|NCT03093402|147596771|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Mean Difference (Final Values)|-0.7||||0.419|TWO_SIDED|95.0|-2.2|0.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for Low JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.8|-2.2|0.4190
74082661|NCT01139762|147717764|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.39|1.13||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.13|0.39|<0.001
74082662|NCT01139762|147717765|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.||||||0.034
74022056|NCT03093402|147596781|SUPERIORITY|||||||0.594|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 29.||||0.594
74022057|NCT03093402|147596781|SUPERIORITY|||||||0.487|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 57.||||0.487
74022058|NCT03093402|147596781|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 85.||||0.760
74022059|NCT03093402|147596781|SUPERIORITY|||||||0.676|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 113.||||0.676
74022060|NCT03093402|147596782|SUPERIORITY|||||||0.796||||||This p-value is from an exact likelihood ratio test at Day 29 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.796
74022061|NCT03093402|147596782|SUPERIORITY|||||||0.955||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.955
74022062|NCT03093402|147596782|SUPERIORITY|||||||0.211||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.211
74022063|NCT03093402|147596782|SUPERIORITY|||||||0.481||||||This p-value is from an exact likelihood ratio test at Day 113 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.481
74022064|NCT03093402|147596783|SUPERIORITY|||||||0.79||||||This p-value is from an exact likelihood ratio test at Day 29 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.790
74022065|NCT03093402|147596783|SUPERIORITY|||||||0.843||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.843
74022066|NCT03093402|147596783|SUPERIORITY|||||||0.637||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.637
74022067|NCT03093402|147596783|SUPERIORITY|||||||0.243||||||This p-value is from an exact likelihood ratio test at Day 113 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.243
74022068|NCT03093402|147596784|SUPERIORITY||||||>|0.999||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>=100% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||>0.999
74022069|NCT03093402|147596784|SUPERIORITY|||||||0.861||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 100% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.861
74082663|NCT01139762|147717766|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Van Elteren test|Van Elteren test was stratified by region.||||||0.031
74082664|NCT01139762|147717767|SUPERIORITY_OR_OTHER|||||||0.328||95.0||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.||||||0.328
74082665|NCT01139762|147717768|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||Wilcoxon Rank-Sum test|||||||0.157
74082666|NCT01139762|147717769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|||<|0.001|TWO_SIDED|95.0|0.49|0.98||P-value is for Question 3 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.98|0.49|<0.001
74082667|NCT01139762|147717769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.43|0.93||P-value is for Question 3 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.93|0.43|<0.001
74082668|NCT01139762|147717769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75|||<|0.001|TWO_SIDED|95.0|0.48|1.02||P-value is for Question 3 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.02|0.48|<0.001
74082669|NCT01139762|147717769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.46|0.95||P-value is for Question 4 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.95|0.46|<0.001
74082670|NCT01139762|147717769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61|||<|0.001|TWO_SIDED|95.0|0.36|0.85||P-value is for Question 4 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.85|0.36|<0.001
74082671|NCT01139762|147717769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|||<|0.001|TWO_SIDED|95.0|0.35|0.89||P-value is for Question 4 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.89|0.35|<0.001
74082672|NCT00919711|147717776|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.6|||<|0.0001|TWO_SIDED|95.0|1.2|2.0|||ANCOVA||Denosumab - Risedronate|||2.0|1.2|<0.0001
74082673|NCT00919711|147717777|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74082674|NCT00919711|147717778|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|0.9|1.8|||ANCOVA||Denosumab - Risedronate|||1.8|0.9|<0.0001
74082675|NCT00919711|147717779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|1.8|2.8|||ANCOVA||Denosumab - Risedronate|||2.8|1.8|<0.0001
74082676|NCT00087529|147717784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.773||||0.1442|TWO_SIDED|95.0|0.546|1.093||Stratified using the following variables: Baseline EDSS (less than or equal to \[≤\] 4.0 versus \>4.0 points) and prior treatment with interferon-beta or glatiramer acetate.|Log Rank|||||1.093|0.546|0.1442
74082677|NCT00087529|147717786|SUPERIORITY_OR_OTHER||LS mean difference|-718.24||||0.0008|TWO_SIDED|95.0|-1504.48|68.0|||Friedman ranked ANOVA test|||Treatment difference in least-squares (LS) means and the associated 95% confidence intervals were estimated from the analysis of variance (ANOVA) model, which included the following factors: Baseline EDSS (≤ 4.0 versus \>4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.||68.00|-1504.48|0.0008
74082678|NCT00087529|147717787|SUPERIORITY_OR_OTHER||LS mean difference|-1.08||||0.6237|TWO_SIDED|95.0|-9.49|7.34|||Friedman ranked ANOVA test|||Treatment difference in LS means and the associated 95% confidence intervals were estimated from the ANOVA model, which included the following factors: Baseline EDSS (≤ 4.0 versus \>4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.||7.34|-9.49|0.6237
74082679|NCT02535923|147717788|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
74082680|NCT02535923|147717788|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||.83
74082681|NCT02535923|147717789|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||.83
74082682|NCT02535923|147717790|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||.003
74082683|NCT02535923|147717791|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||.16
74082684|NCT02535923|147717792|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||.82
74082685|NCT01541215|147717894|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: change from baseline to week 26 in HbA1c~Superiority of liraglutide over placebo was to be concluded if the 95% confidence interval for the treatment difference for change from baseline in HbA1c (%) after 26 weeks of randomised treatment was entirely below 0%, implying that the two sided p-value was less than 5%."|Treatment difference|-1.058|STANDARD_ERROR_OF_MEAN|0.304|<|0.001|TWO_SIDED|95.0|-1.653|-0.464|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for week 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||-0.464|-1.653|<0.001
74082686|NCT01541215|147717895|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Change from baseline in FPG after 26 weeks of treatment"|Treatment difference|-1.878|STANDARD_ERROR_OF_MEAN|0.62||0.002|TWO_SIDED|95.0|-3.093|-0.662|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||-0.662|-3.093|0.002
74082687|NCT01541215|147717896|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: HbA1c \< 7.0% after 26 weeks of treatment"|Treatment odds ratio|5.353|||<|0.001|TWO_SIDED|95.0|2.105|13.615|||logistic regression model|||Missing data was imputed using pattern mixture model. For each imputed data set the binary response was analysed in a logistic regression model using a logit link with treatment and stratification group (gender\*age group) as fixed factors and baseline HbA1c as covariate.The estimated treatment effects and confidence intervals were combined using Rubin´s formula.||13.615|2.105|<0.001
74082688|NCT01541215|147717897|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Change from baseline in BMI SDS after 26 weeks of treatment"|Treatment difference|-0.047|STANDARD_ERROR_OF_MEAN|0.055||0.392|TWO_SIDED|95.0|-0.153|0.06|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||0.060|-0.153|0.392
74082689|NCT01472432|147717984|SUPERIORITY_OR_OTHER||||||<|0.05||||||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."|t-test, 2 sided|"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||||<0.05
74082690|NCT01472432|147717985|SUPERIORITY_OR_OTHER||||||<|0.05||||||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months"|t-test, 2 sided|"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months"||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||||<0.05
74082691|NCT01472432|147717986|SUPERIORITY_OR_OTHER||||||<|0.05||||||P-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months. P\< 0.05 versus control patients. P \< 0.05 versus baseline.|t-test, 2 sided|||p-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months.||||<0.05
74082692|NCT01472432|147717987|SUPERIORITY_OR_OTHER||||||<|0.05||||||P\< 0.05 versus control patients. P \< 0.05 versus baseline|t-test, 2 sided|||||||<0.05
74082693|NCT01884844|147718090|SUPERIORITY|||||||0.89|||||||Fisher Exact|||||||0.89
74082694|NCT02906917|147718111|NON_INFERIORITY|Non-inferiority of IDegAsp OD versus IGlar OD + IAsp OD was considered confirmed if the 95% confidence interval for the mean treatment difference was entirely below 0.40%.|Treatment contrast|0.07|||<|0.0001|TWO_SIDED|95.0|-0.06|0.21||One-sided p-value for test of non-inferiority.|ANCOVA|Treatment, region, sex, previous insulin treatment and previous OAD treatment as categorical fixed effects and baseline response and age as covariate.||The response and change from baseline in response are analysed on 1000 complete, imputed data sets after multiple imputation for each treatment arm separately. A penalty of 0.4% is added to the week 26 values for all premature treatment discontinued subjects, and subject with missing HbA1c values at week 26 in the IDegAsp arm. Each of the imputed data sets are analysed through an analysis of covariance (ANCOVA).||0.21|-0.06|<0.0001
74082695|NCT00874822|147718166|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|19.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|13.6|24.4|||Chi-squared, Corrected|||"Ho: The Prevalence of obstructive sleep apnea in patients planning hip or knee arthroplasty will be no different using current screening techniques than it was in a historical control group.~The prevalence of OSA in the study population is hypothesized to be at least 10% higher than the best previous estimate of 6.7%. Employing a two-sided hypothesis test with α of 0.05 and power of 0.85 yields a sample size of 163."||24.4|13.6|<0.0001
74082696|NCT02854800|147718168|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||A separate t-test for each row was used to compare dropouts and completers.||||<0.05
74082697|NCT02854800|147718170|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||One-way ANOVA was used to compare mean medication side effect ratings across the three arms/groups to determine whether one group had more severe symptoms that may have been related to study dropout.||||<0.05
74082698|NCT02854800|147718173|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Mixed ANOVA was used with Study Week (1-12) as the within-subjects, repeated-measures factor and Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
74082699|NCT02854800|147718174|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||One-way ANOVA was used for each side effect rating with Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
74082700|NCT02854800|147718175|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
74082701|NCT02854800|147718177|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
74082702|NCT02627963|147718236|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0165|TWO_SIDED|95.0|0.56|0.94||A one-sided, log-rank test stratified for IMDC risk category and prior therapy (two VEGFR TKIs vs. a checkpoint inhibitor plus a VEGFR TKI vs. a VEGFR TKI plus any other systemic agent) at a significance level of α = 0.025 was used.|Log Rank|||||0.94|0.56|0.0165
74082703|NCT02627963|147718237|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8174|TWO_SIDED|95.0|0.75|1.25|||Log Rank|||||1.25|0.75|0.8174
74082705|NCT01322633|147718251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.24|1.93||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.93|0.24|
74082706|NCT01322633|147718252|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.65|1.4||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.40|0.65|
74082707|NCT01322633|147718253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.93|1.21||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.21|0.93|
74082708|NCT05109104|147718263|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|25.0|||||TWO_SIDED|||||||||||||
74082709|NCT05109104|147718263|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|25.0|||||TWO_SIDED|||||||||||||
74082710|NCT05109104|147718263|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|27.0|||||TWO_SIDED|||||||||||||
74082711|NCT03807440|147718276|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
74082712|NCT03807440|147718277|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082713|NCT03807440|147718278|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
74082714|NCT03807440|147718279|OTHER|||||||0.8071|||||||Chi-squared|||||||0.8071
74082715|NCT03807440|147718279|OTHER|||||||0.764|||||||Fisher Exact|||||||0.7640
74082716|NCT03807440|147718280|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
74082717|NCT03807440|147718281|OTHER|||||||0.0042|||||||Chi-squared|||||||0.0042
74082718|NCT03807440|147718282|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
74082719|NCT03807440|147718283|OTHER|||||||0.399|||||||Chi-squared|||||||0.3990
74082720|NCT03807440|147718283|OTHER|||||||0.3842|||||||Fisher Exact|||||||0.3842
74082721|NCT03807440|147718284|OTHER|||||||0.0605|||||||Kruskal-Wallis|||||||0.0605
74082722|NCT03807440|147718285|OTHER|||||||0.6329|||||||Chi-squared|||||||0.6329
74082723|NCT03807440|147718285|OTHER|||||||0.7181|||||||Fisher Exact|||||||0.7181
74082724|NCT03807440|147718286|OTHER|||||||0.5233|||||||Kruskal-Wallis|||||||0.5233
74082725|NCT03807440|147718288|OTHER|||||||0.3662|||||||Kruskal-Wallis|||||||0.3662
74082726|NCT03807440|147718289|OTHER|||||||0.511|||||||Kruskal-Wallis|||||||0.5110
74082727|NCT03807440|147718290|OTHER|||||||0.0921|||||||Kruskal-Wallis|||||||0.0921
74082728|NCT03807440|147718291|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
74082729|NCT03807440|147718292|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082730|NCT03807440|147718293|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
74082731|NCT03807440|147718294|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082732|NCT03807440|147718295|OTHER|||||||0.3201|||||||Kruskal-Wallis|||||||0.3201
74082733|NCT03807440|147718296|OTHER|||||||0.3288|||||||Chi-squared|||||||0.3288
74082734|NCT03807440|147718296|OTHER|||||||0.171|||||||Fisher Exact|||||||0.1710
74082735|NCT03807440|147718297|OTHER|||||||0.013|||||||Kruskal-Wallis|||||||0.0130
74082736|NCT03807440|147718298|OTHER|||||||0.0026|||||||Kruskal-Wallis|||||||0.0026
74082737|NCT03807440|147718299|OTHER|||||||0.3978|||||||Kruskal-Wallis|||||||0.3978
74082738|NCT03807440|147718300|OTHER|||||||0.0055|||||||Chi-squared|||||||0.0055
74082739|NCT03807440|147718300|OTHER|||||||0.0041|||||||Fisher Exact|||||||0.0041
74082740|NCT03807440|147718301|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082741|NCT03807440|147718302|OTHER|||||||0.0399|||||||Chi-squared|||||||0.0399
74082742|NCT03807440|147718302|OTHER|||||||0.0401|||||||Fisher Exact|||||||0.0401
74082743|NCT03807440|147718320|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082744|NCT03807440|147718321|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082745|NCT03807440|147718322|OTHER|||||||0.0008|||||||Chi-squared|||||||0.0008
74082746|NCT03807440|147718324|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082747|NCT03807440|147718325|OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
74082748|NCT03807440|147718326|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082749|NCT03807440|147718327|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082750|NCT03807440|147718328|OTHER|||||||0.9184|||||||Chi-squared|||||||0.9184
74082751|NCT03807440|147718328|OTHER|||||||0.9911|||||||Fisher Exact|||||||0.9911
74082752|NCT03807440|147718329|OTHER|||||||0.6967|||||||Chi-squared|||||||0.6967
74082753|NCT03807440|147718329|OTHER|||||||0.6439|||||||Fisher Exact|||||||0.6439
74082754|NCT03807440|147718330|OTHER|||||||0.9414|||||||Chi-squared|||||||0.9414
74082755|NCT03807440|147718330|OTHER|||||||0.8142|||||||Fisher Exact|||||||0.8142
74082756|NCT03807440|147718331|OTHER|||||||0.7837|||||||Chi-squared|||||||0.7837
74082757|NCT03807440|147718331|OTHER|||||||0.7538|||||||Fisher Exact|||||||0.7538
74082758|NCT03807440|147718332|OTHER|||||||0.0012|||||||Chi-squared|||||||0.0012
74082759|NCT03807440|147718333|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082760|NCT03807440|147718334|OTHER|||||||0.1906|||||||Chi-squared|||||||0.1906
74082761|NCT03807440|147718335|OTHER|||||||0.6198|||||||Chi-squared|||||||0.6198
74082762|NCT03807440|147718335|OTHER|||||||0.7297|||||||Fisher Exact|||||||0.7297
74082763|NCT03807440|147718337|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082764|NCT03807440|147718338|OTHER|||||||0.0012|||||||Chi-squared|||||||0.0012
74082765|NCT03807440|147718338|OTHER|||||||0.0002|||||||Fisher Exact|||||||0.0002
74082766|NCT03807440|147718339|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74082767|NCT03807440|147718342|OTHER|||||||0.003|||||||Log Rank|||||||0.0030
74082768|NCT00323258|147718343|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in proportion of participants adherent to triple therapy in the treatment arm compared to those who receive usual care."||||||0.5|||||||Chi-squared|||Sample size of 286 patients(143 patients per group).Based on an estimated absolute improvement in medication adherence of 15% in the intervention group (eg, 85% in the intervention group, 70% in the control group), a 2-sided test with α level of .05, a 15% dropout rate, and power of 0.80.||||.50
74082769|NCT00323258|147718344|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to combined beta-blocker and statin therapy in the treatment arm compared to those who receive usual care."|||||=|0.11|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||=0.11
74082770|NCT00323258|147718345|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to beta-blockers in the treatment arm compared to those who receive usual care."||||||0.03|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||0.03
74082771|NCT00323258|147718346|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to statins in the treatment arm compared to those who receive usual care."||||||0.34|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||0.34
74082772|NCT01586039|147718349|SUPERIORITY|||||||0.73||||||Contrasting LED vs. CFL at 90 lux intensity|t-test, 2 sided|Paired t-test.||Contrasting LED vs. CFL at 90 lux intensity. Melatonin suppression is measured as the percentage of melatonin AUC relative to the AUC measured in dim light on the previous day. Higher values indicate more light-induced melatonin suppression.||||0.73
74082773|NCT01586039|147718349|SUPERIORITY|||||||0.001||||||Contrasting LED vs. CFL at 50 lux intensity|t-test, 2 sided|Paired t-test||Contrasting LED vs. CFL at 50 lux intensity||||0.001
74082774|NCT01586039|147718350|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Paired t-test||||||0.19
74082775|NCT01586039|147718352|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|Paired t-test.||||||0.17
74082776|NCT01586039|147718352|SUPERIORITY|||||||1|||||||t-test, 2 sided|Paired test.||||||1.0
74082777|NCT01728636|147718426|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||.05
74082778|NCT00354159|147718450|SUPERIORITY_OR_OTHER||6-month survival rate|90.5|||<|0.001|ONE_SIDED|97.5|87.7|||The survival estimate at 6-months post-implant was compared to 80%. The comparison was made using the cumulative hazard \[e.g. log survival estimate\] for the variance.|Survival estimate at 6-months|The survival estimate at 6-months post-implant was compared to 80%.||"Null hypothesis: Freedom from Chronicle system-related complications at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Freedom from Chronicle system-related complications at 6-months is greater than 80%."|||87.7|<0.001
74082779|NCT00354159|147718452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.978|TWO_SIDED|95.0|0.61|1.61||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"The study was originally powered at 80% to detect a 25% risk reduction between the treatment arm and control arm with a type I error rate of 0.05. Under these assumptions 648 HF-related events from approximately 1300 subjects were required. The study stopped after 400 were randomized.~Null Hypothesis: The HF-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The HF-related event rate between the treatment arm and control arm is different."||1.61|0.61|0.978
74082780|NCT00354159|147718453|SUPERIORITY_OR_OTHER|||||||0.574||95.0|||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: mu(Treatment) = mu(Control) Alternative Hypothesis: mu(Treatment) ne mu(Control)~where mu is the percentage of hospitalized days for heart failure."||||0.574
74082781|NCT00354159|147718454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.527|TWO_SIDED|95.0|0.62|1.28||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill Model||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The CV-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The CV-related event rate between the treatment arm and control arm is different."||1.28|0.62|0.527
74082782|NCT00354159|147718455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.505|TWO_SIDED|95.0|0.57|1.32|||Regression, Cox|The treatment and control hazard ratio and 95% confidence interval was estimated using a univariate cox Regression Model.|Hazard Ratio is for the Treatment Arm relative to the Control Arm|"Null Hypothesis: Freedom from death or HF-related hospitalization is the same between the treatment arm and the control arm.~Alternative Hypothesis: Freedom from death or HF-related hospitalization is different between the treatment arm and the control arm."||1.32|0.57|0.505
74082783|NCT00354159|147718456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.088|TWO_SIDED|95.0|0.56|1.04|||Andersen-Gill Model|The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The all cause event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The all cause event rate between the treatment arm and control arm is different."||1.04|0.56|0.088
74082784|NCT00354159|147718457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.758|TWO_SIDED|95.0|0.73|1.54||P-value is from a proportional odds model comparing the distribution of composite endpoint response between the treatment arm and control arm.|Proportional odds model||Odds ratio represents the odds of improved score in the treatment group relative to the control group.|"Null Hypothesis: Distribution of composite response endpoint is the same between the treatment arm and the control arm.~Alternative Hypothesis: Distribution of composite response endpoint is different between the treatment arm and the control arm."||1.54|0.73|0.758
74082785|NCT00354159|147718460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.599|TWO_SIDED|95.0|0.29|2.06|||Regression, Cox|The treatment to control hazard ratio and 95% confidence interval was estimated using a univariate Cox Regression Model|Hazard ratio estimates the hazard of death in the treatment group relative to the control group.|"Null hypothesis: Survival during the 12-month randomized follow-up period is the same between the treatment and control groups.~Alternative hypothesis: Survival during the 12-month randomized period is different between the treatment and control groups."||2.06|0.29|0.599
74082786|NCT00354159|147718461|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Negative-Binomial Regression|||The null hypothesis is that the rate of cardiovascular medication changes is the same between the Treatment Arm and Control Arm.||||0.145
74082787|NCT00354159|147718462|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||t-test, 2 sided|||"Null hypothesis: Average daily median ePAD is the same between the Treatment and Control arms.~Alternative hypothesis: Average daily median ePAD is the different between the Treatment and Control arms."||||0.033
74082788|NCT00354159|147718463|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||"Null Hypothesis: The average daily median ePAD is not different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period.~Alternative Hypothesis: The average daily median ePAD is different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period."||||0.002
74082789|NCT00354159|147718464|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.292|TWO_SIDED|95.0|0.82|1.96|||Proportional odds regression model||Direction for odds ratio is the odds of improvement in the Treatment arm versus the odds of improvement in the Control arm.|"Null Hypothesis: There is no difference in the change in NYHA functional class between the Treatment and Control Arms.~Alternative Hypothesis: There is a difference in the change in NYHA functional class between the Treatment and Control Arms."||1.96|0.82|0.292
74082790|NCT00354159|147718465|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Mixed Models Analysis|||"Null Hypothesis: The change in 6-minute hall walk distance is not different between the Treatment and Control Arms.~Alternative Hypothesis: The change in 6-minute hall walk distance is different between the Treatment and Control Arms."||||0.996
74082791|NCT00354159|147718466|SUPERIORITY_OR_OTHER|||||||0.154||95.0|||||Mixed Models Analysis|||"Null Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is the same between the Treatment arm and Control arm.~Alternative Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is different between the Treatment arm and Control arm."||||0.154
74082792|NCT00354159|147718469|SUPERIORITY_OR_OTHER|||||||0.583||95.0|||||Mixed Models Analysis|Response was change in MNLWHF score from baseline. Model adjusted for baseline MNLWHF score. Negative changes mean an improvement in MNLWHF score.||"Null Hypothesis: There is no difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm.~Alternative Hypothesis: There is a difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm."||||0.583
74082793|NCT00354159|147718470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.48||||0.368|TWO_SIDED|95.0|0.63|3.5||The P-value is from the Andersen-Gill model which adjusts for multiple VT/VF episodes per subject.|Andersen-Gill Model|Andersen-Gill model included a term for Treatment Arm. This model adjusts for multiple events per subject.||"Null Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is the same between the Treatment Arm and the Control Arm.~Alternative Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is different between the Treatment Arm and the Control Arm."||3.5|0.63|0.368
74082794|NCT03405363|147718499|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.2|||||TWO_SIDED|95.0|0.98|1.47|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|||1.47|0.98|
74082795|NCT03405363|147718500|OTHER||Adjusted Incidence Rate Ratio|1.83|||||TWO_SIDED|95.0|0.9|3.74|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||3.74|0.90|
74082796|NCT03405363|147718501|OTHER||Adjusted Incidence Rate Ratio|1.3|||||TWO_SIDED|95.0|0.71|2.36|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||2.36|0.71|
74082797|NCT03405363|147718502|OTHER||Adjusted Incidence Rate Ratio|1.22|||||TWO_SIDED|95.0|0.79|1.87|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||1.87|0.79|
74082798|NCT03405363|147718503|OTHER||Adjusted Incidence Rate Ratio|1.0|||||TWO_SIDED|95.0|0.64|1.56|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||1.56|0.64|
74082799|NCT03405363|147718504|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.63|||||TWO_SIDED|95.0|1.44|1.84|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|Analysis was based on Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry.||1.84|1.44|
74082800|NCT03405363|147718504|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.48|||||TWO_SIDED|95.0|1.23|1.78|||Poisson regression model||Olodaterol compared to 'other LABA' as reference|"Analysis based on post-hoc population 1.~Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications, fixed-dose combinations of Short-Acting Beta2- Agonist and Short-Acting Muscarinic Antagonist and systemic antibacterials. COPD severity, number of: all-cause hospitalisations 365 and 180 days, COPD exacerbations 180 and 90 days, COPD hospitalisations 180 and 90 days, and COPD exacerbations 90 days before index date."||1.78|1.23|
74082801|NCT03405363|147718504|OTHER|No formal hypotheses were tested.|Adjusted Incidende Rate Ratio|1.26|||||TWO_SIDED|95.0|0.97|1.64|||Poisson regression model||Olodaterol compared to 'other LABA' as reference|Analysis based on post-hoc population 2. Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications. COPD severity, number of all-cause hospitalisations 180 days, COPD exacerbations 180 days before cohort entry.||1.64|0.97|
74082802|NCT02533466|147718505|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|-0.08||||0.2673|TWO_SIDED|95.0|-1.0|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-1.0|0.2673
74082803|NCT02533466|147718506|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-0.92||||0.069|TWO_SIDED|95.0|-1.8|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum Test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-1.8|0.0690
74082804|NCT02533466|147718507|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.5||||0.068|TWO_SIDED|95.0|-2.7|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-2.7|0.0680
74082805|NCT02533466|147718508|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.83||||0.0654|TWO_SIDED|95.0|-3.0|0.0||P-value is calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test.||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product"|||0.0|-3.0|0.0654
74082806|NCT02533466|147718509|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-1.4||||0.6061|TWO_SIDED|95.0|-6.8|4.1||P value obtained from the ANCOVA analysis|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||4.1|-6.8|0.6061
74082807|NCT02533466|147718510|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-2.3||||0.408|TWO_SIDED|95.0|-7.9|3.3||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product|||3.3|-7.9|0.4080
74082808|NCT02533466|147718511|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|0.21||||0.4611|TWO_SIDED|95.0|-0.4|0.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||0.8|-0.4|0.4611
74082809|NCT02533466|147718512|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Net)|0.09||||0.3939|TWO_SIDED|95.0|-0.1|0.3||P value obtained from the ANCOVA analysis.|ANCOVA|||||0.3|-0.1|0.3939
74082810|NCT02533466|147718513|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|0.34||||0.7829|TWO_SIDED|95.0|-2.2|2.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||2.8|-2.2|0.7829
74082811|NCT02533466|147718514|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Mean Difference (Final Values)|-0.08||||0.9121|TWO_SIDED|95.0|-1.6|1.4||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||1.4|-1.6|0.9121
74082812|NCT03277248|147718520|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.509||||0.0022|TWO_SIDED|95.0|0.33|0.784||GEE (Generalized Estimating Equation) model for the relapse count per participant with logarithmic link function, treatment, region, and baseline Expanded Disability Status Scale (EDSS) strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.784|0.330|0.0022
74082813|NCT03277248|147718521|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.035|||<|0.0001|TWO_SIDED|95.0|0.019|0.064||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.064|0.019|<.0001
74082814|NCT03277248|147718522|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.1|||<|0.0001|TWO_SIDED|95.0|0.073|0.136||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.136|0.073|<.0001
74082815|NCT03277248|147718524|SUPERIORITY||Odds Ratio (Ublituximab / Teriflunomide)|7.946|||<|0.0001|TWO_SIDED|95.0|4.917|12.841||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1-unenhancing, T2, Gd-enhancing) as covariates.|Regression, Logistic|||||12.841|4.917|<.0001
73836859|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.03|0.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.74|0.03|
74082816|NCT03277248|147718525|SUPERIORITY||Odds Ratio (Ublituximab / Teriflunomide)|0.862||||0.429|TWO_SIDED|95.0|0.596|1.246||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Regression, Logistic|||||1.246|0.596|0.4290
74082817|NCT03277248|147718526|SUPERIORITY||Least Squares Mean Difference|-0.018||||0.3108|TWO_SIDED|95.0|-0.053|0.017||Mixed model repeated measures (MMRM) model includes treatment, region, baseline EDSS strata, visit, treatment-by-visit interaction, and baseline volume (cube root transformed) as covariates and an unstructured covariance matrix.|Mixed Model Repeated Measures|||||0.017|-0.053|0.3108
74082818|NCT01894230|147718539|EQUIVALENCE|Month 3|Slope|-0.0189|STANDARD_ERROR_OF_MEAN|0.3986||0.96|TWO_SIDED||||||Regression, Linear|||||||0.96
74082819|NCT01894230|147718539|EQUIVALENCE|Month 8|Slope|-0.2468|STANDARD_ERROR_OF_MEAN|0.4315||0.57|TWO_SIDED||||||Regression, Linear|||||||0.57
74082820|NCT01894230|147718540|EQUIVALENCE|Month 3|Slope|-11.32|STANDARD_ERROR_OF_MEAN|5.68||0.0482|TWO_SIDED||||||Regression, Linear|||||||0.0482
74082821|NCT01894230|147718540|EQUIVALENCE|Month 8|Slope|-9.9|STANDARD_ERROR_OF_MEAN|6.333||0.12|TWO_SIDED||||||Regression, Linear|||||||0.12
74082822|NCT01894230|147718541|EQUIVALENCE|MPR calculated from baseline to last patient follow-up (3 months or 8 months)|Slope|-0.053|STANDARD_ERROR_OF_MEAN|0.091||0.6692|TWO_SIDED||||||Regression, Linear|||||||0.6692
74082823|NCT01894230|147718542|EQUIVALENCE|Baseline to Month 3|Odds Ratio (OR)|2.025||||0.0371|TWO_SIDED|95.0|1.043|3.929|||Regression, Logistic|||||3.929|1.043|0.0371
74082824|NCT01894230|147718542|EQUIVALENCE|Month 3 to Month 8|Odds Ratio (OR)|1.115||||0.8815|TWO_SIDED|95.0|0.265|4.687|||Regression, Logistic|||||4.687|0.265|0.8815
74082825|NCT01894230|147718543|EQUIVALENCE|Month 3|Slope|0.143|STANDARD_ERROR_OF_MEAN|0.27||0.5965|TWO_SIDED||||||Regression, Linear|||||||0.5965
74082826|NCT01894230|147718543|EQUIVALENCE|Month 8|Slope|0.258|STANDARD_ERROR_OF_MEAN|0.346||0.4579|TWO_SIDED||||||Regression, Linear|||||||0.4579
74082827|NCT01894230|147718544|EQUIVALENCE|Month 3|Slope|0.098|STANDARD_ERROR_OF_MEAN|0.163||0.5477|TWO_SIDED||||||Regression, Linear|||||||0.5477
74082828|NCT01894230|147718544|EQUIVALENCE|Month 8|Slope|0.298|STANDARD_ERROR_OF_MEAN|0.145||0.0429|TWO_SIDED||||||Regression, Linear|||||||0.0429
74082829|NCT01894230|147718545|EQUIVALENCE|Month 3|Slope|-0.211|STANDARD_ERROR_OF_MEAN|0.881||0.8106|TWO_SIDED||||||Regression, Linear|||||||0.8106
74082830|NCT01894230|147718545|EQUIVALENCE|Month 8|Slope|0.646|STANDARD_ERROR_OF_MEAN|1.009||0.5233|TWO_SIDED||||||Regression, Linear|||||||0.5233
74082831|NCT01894230|147718546|EQUIVALENCE|Month 3|Slope|-0.6001|STANDARD_ERROR_OF_MEAN|1.472||0.6841|TWO_SIDED||||||Regression, Linear|||||||0.6841
74082832|NCT01894230|147718546|EQUIVALENCE|Month 8|Slope|-0.771|STANDARD_ERROR_OF_MEAN|1.781||0.6658|TWO_SIDED||||||Regression, Linear|||||||0.6658
74082833|NCT01894230|147718547|EQUIVALENCE|Month 8|Odds Ratio (OR)|1.085||||0.8384|TWO_SIDED|95.0|0.495|2.38|||Regression, Logistic|Ordinal Logistic||||2.380|0.495|0.8384
74082834|NCT01894230|147718548|EQUIVALENCE|Month 3 BMQ Necessity|Slope|1.163|STANDARD_ERROR_OF_MEAN|0.584||0.0486|TWO_SIDED||||||Regression, Linear|||||||0.0486
74082835|NCT01894230|147718548|EQUIVALENCE|Month 8, BMQ Necessity|Slope|0.248|STANDARD_ERROR_OF_MEAN|0.67||0.7235|TWO_SIDED||||||Regression, Linear|||||||0.7235
74082836|NCT01894230|147718548|EQUIVALENCE|Month 3, BMQ Concerns|Slope|-0.862|STANDARD_ERROR_OF_MEAN|0.686||0.2113|TWO_SIDED||||||Regression, Linear|||||||0.2113
74082837|NCT01894230|147718548|EQUIVALENCE|Month 8, BMQ Concerns|Slope|-1.0083|STANDARD_ERROR_OF_MEAN|0.737||0.1739|TWO_SIDED||||||Regression, Linear|||||||0.1739
74082838|NCT03930849|147718556|OTHER||F-value for Type 3 Fixed, df=4|2.01||||0.1|TWO_SIDED||||||Mixed Models Analysis|P-value is for F-value reported below of group x time term in a mixed methods analysis.||||||0.10
74082839|NCT03930849|147718557|SUPERIORITY||F statistic GroupxTime, df=4|0.025||||0.9|TWO_SIDED||||||Mixed Models Analysis|P-value is for F-value reported below of group x time analysis in a mixed methods analysis.||||||0.90
74082840|NCT03930849|147718558|SUPERIORITY||F Value Group x Time, DF=4|2.12||||0.08|TWO_SIDED|||||P-value of F statistic reported below for mixed methods analysis group\*time interaction term.|Mixed Models Analysis|||||||0.08
74082841|NCT02488109|147718559|OTHER|||||||0.42||||||Changes in rates of clinical remission by group over time in the mITT model.|Regression, Linear|Clinical remission was modeled as a nominal multinomial outcome (yes, no, or missing)||The study was powered to detect a difference in 12-months clinical remission rates between groups. N = 60 per arm with 85% retention would provide 80% power on a 2-sided 0.05-level test to detect a 20% difference between groups in 12-months clinical remission rates. A generalized linear mixed-effects regression model was used to compare study arms with respect to achievement and maintenance of clinical remission.||||0.42
74082842|NCT02488109|147718560|SUPERIORITY||Hazard Ratio (HR)|1.67||||0.01|TWO_SIDED|95.0|1.1|2.53||Survival analysis of time to medical stability by log-rank test, which does not assume proportional hazards. Those who did not reach medical stability before hospital discharge were censored; analyses accounted for the site effect by stratification.|Survival analysis with log rank test|Compared time to achieve medical stability by arm; participants who did not meet stability criteria by hospital discharge were right-censored||This trial was powered at 0.80 to detect a 12% to 20% difference in restored medical stability at 0.05 type I error and correlation between time points from 0.1 to 1.||2.53|1.10|0.01
74082843|NCT02488109|147718561|SUPERIORITY||Median Difference (Net)|19.0||||0.002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Cost outcomes of group differences and 95% confidence intervals were estimated.||28,819|9,293|0.002
74082844|NCT00660387|147718562|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.91|STANDARD_ERROR_OF_MEAN|0.57||0.0015|TWO_SIDED|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA|||||-0.76|-3.05|0.0015
74082845|NCT00660387|147718563|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.86|STANDARD_ERROR_OF_MEAN|0.65||0.0059|TWO_SIDED|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||3.17|0.56|0.0059
74082846|NCT00660387|147718564|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-7.0|STANDARD_ERROR_OF_MEAN|2.8||0.0155|TWO_SIDED|95.0|-12.6|-1.4||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the CGI-Severity (CGI-S, see Baseline Characteristics module) as a covariate.|ANCOVA|||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-1.4|-12.6|0.0155
74082847|NCT00660387|147718565|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0258|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.1|-1.4|0.0258
74082848|NCT00660387|147718566|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.0086|TWO_SIDED|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.8|-5.3|0.0086
74082849|NCT00660387|147718567|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.502|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||5.6|-2.8|0.5020
74082850|NCT00660387|147718568|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.07|STANDARD_ERROR_OF_MEAN|0.038||0.067|TWO_SIDED|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||0.146|-0.005|0.0670
74082851|NCT00660387|147718569|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.1||0.1501|TWO_SIDED|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||1.7|-10.7|0.1501
74082852|NCT00660387|147718570|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.08|STANDARD_ERROR_OF_MEAN|0.45||0.8574|TWO_SIDED|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.82|-0.98|0.8574
74082853|NCT00660387|147718571|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-10.4|STANDARD_ERROR_OF_MEAN|4.3||0.0184|TWO_SIDED|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-1.8|-19.1|0.0184
74082854|NCT00660387|147718572|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-11.6|STANDARD_ERROR_OF_MEAN|4.5||0.0129|TWO_SIDED|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-2.5|-20.6|0.0129
73836860|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.1|||||TWO_SIDED|95.0|0.02|0.84||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.84|0.02|
74082855|NCT00660387|147718573|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-2.2|STANDARD_ERROR_OF_MEAN|3.4||0.5246|TWO_SIDED|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.6|-9.0|0.5246
74082856|NCT00660387|147718574|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.2423|TWO_SIDED|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||3.1|-12.0|0.2423
74082857|NCT00660387|147718575|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.8|STANDARD_ERROR_OF_MEAN|3.1||0.2243|TWO_SIDED|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.4|-9.9|0.2243
73836861|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|4.8|||||TWO_SIDED|95.0|1.35|16.98||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||16.98|1.35|
73836862|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.28|3.23||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.23|0.28|
73836863|NCT01026038|147222735|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.05|0.85||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.85|0.05|
74082858|NCT00660387|147718576|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.0|STANDARD_ERROR_OF_MEAN|3.4||0.2407|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.8|-10.8|0.2407
74082859|NCT00660387|147718577|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-13.8|STANDARD_ERROR_OF_MEAN|3.5||0.0002|TWO_SIDED|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-6.8|-20.8|0.0002
74082860|NCT00660387|147718578|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.3|STANDARD_ERROR_OF_MEAN|5.1||0.5213|TWO_SIDED|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||6.9|-13.6|0.5213
74082861|NCT00660387|147718579|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3741|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.9|-0.4|0.3741
74082862|NCT00660387|147718580|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0361|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-0.1|-2.4|0.0361
74082863|NCT00660387|147718581|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3578|TWO_SIDED|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.4|-1.1|0.3578
74082864|NCT00660387|147718582|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.5|STANDARD_ERROR_OF_MEAN|2.9||0.6088|TWO_SIDED|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.4|-7.4|0.6088
74082865|NCT00660387|147718583|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|11.4|STANDARD_ERROR_OF_MEAN|3.7||0.0033|TWO_SIDED|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||18.9|4.0|0.0033
74082866|NCT01251393|147718589|EQUIVALENCE|"The comparisons between the placebo and the biperiden groups at baseline were performed by means of the independent t-Test. We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.~We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack."|||||<|0.05||||||We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack.|ANOVA|||We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.||||<0.05
74082867|NCT03086135|147718590|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 3 months with the Osia system vs Unaided at visit 1||||<0.0001
74082868|NCT03086135|147718591|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in noise at 3 months with the Osia system vs Unaided at visit 1||||<0.0001
74082869|NCT03086135|147718592|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082870|NCT03086135|147718592|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082871|NCT03086135|147718592|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082872|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry 250Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
73836864|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.38||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.38|0.80|
74082873|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082874|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082875|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082876|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082877|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082878|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082879|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082880|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082881|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082882|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082883|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082884|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
73836865|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.76|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.76|
74082885|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082886|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082887|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082888|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082889|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082890|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082891|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082892|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082893|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082894|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082895|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082896|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082897|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082898|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082899|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082900|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082901|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082902|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082903|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082904|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082905|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082906|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082907|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082908|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082909|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082910|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082911|NCT03086135|147718593|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082912|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082913|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082914|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082915|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082916|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082917|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082918|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082919|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082920|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082921|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082922|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Speech in quiet at 65dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082923|NCT03086135|147718594|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082924|NCT03086135|147718595|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
74082925|NCT03086135|147718595|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082926|NCT03086135|147718595|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082927|NCT03086135|147718596|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082928|NCT03086135|147718596|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082929|NCT03086135|147718596|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082930|NCT03086135|147718596|SUPERIORITY|||||||0.51|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 3 months with the Osia system vs Unaided at visit 1.||||0.51
74082931|NCT03086135|147718596|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Global score, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082932|NCT03086135|147718596|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082933|NCT03086135|147718596|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082934|NCT03086135|147718596|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082935|NCT03086135|147718596|SUPERIORITY|||||||0.32|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 12 months with the Osia system vs Unaided at visit 1.||||0.32
74082936|NCT03086135|147718596|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Global score, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082937|NCT03086135|147718597|SUPERIORITY|||||||0.026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Comprehensive health state at 3 months with the Osia system vs Unaided at visit 1.||||0.026
74082938|NCT03086135|147718597|SUPERIORITY|||||||0.5|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Vision attribute at 3 months with the Osia system vs Unaided at visit 1.||||0.50
74082939|NCT03086135|147718597|SUPERIORITY|||||||0.0008|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.0008
74082940|NCT03086135|147718597|SUPERIORITY|||||||0.082|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.082
74082941|NCT03086135|147718597|SUPERIORITY|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.13
74082942|NCT03086135|147718597|SUPERIORITY|||||||0.9|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Dexterity attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.9
74082943|NCT03086135|147718597|SUPERIORITY|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.43
74082944|NCT03086135|147718597|SUPERIORITY|||||||0.31|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.31
74082945|NCT03086135|147718597|SUPERIORITY|||||||0.72|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Pain attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.72
74082946|NCT03086135|147718597|SUPERIORITY|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Comprehensive Health State attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.13
74082947|NCT03086135|147718597|SUPERIORITY|||||||0.23|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Vision attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.23
74082948|NCT03086135|147718597|SUPERIORITY|||||||0.0026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.0026
74082949|NCT03086135|147718597|SUPERIORITY|||||||0.0024|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.0024
74082950|NCT03086135|147718597|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.16
74082951|NCT03086135|147718597|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Dexterity attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.16
74082952|NCT03086135|147718597|SUPERIORITY|||||||0.85|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.85
74082953|NCT03086135|147718597|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 12 months with the Osia system vs Unaided at visit 1.||||1.0
74082954|NCT03086135|147718597|SUPERIORITY|||||||0.56|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Pain attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.56
74082955|NCT03086135|147718598|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Total score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082956|NCT03086135|147718598|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Speech score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082957|NCT03086135|147718598|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Spatial score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082958|NCT03086135|147718598|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Quality score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082959|NCT03086135|147718598|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Total score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082960|NCT03086135|147718598|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Speech score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082961|NCT03086135|147718598|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Spatial score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082962|NCT03086135|147718598|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Quality score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
74082963|NCT03086135|147718599|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082964|NCT03086135|147718599|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082965|NCT03086135|147718599|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082966|NCT03086135|147718599|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082967|NCT03086135|147718600|SUPERIORITY|||||||0.025|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.025
74082968|NCT03086135|147718600|SUPERIORITY|||||||0.096|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.096
74082969|NCT03086135|147718600|SUPERIORITY|||||||0.015|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.015
74082970|NCT03086135|147718600|SUPERIORITY|||||||0.67|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.67
74082971|NCT03086135|147718600|SUPERIORITY|||||||0.73|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.73
74082972|NCT03086135|147718600|SUPERIORITY|||||||0.019|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.019
74082973|NCT03086135|147718600|SUPERIORITY|||||||0.0046|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.0046
74082974|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082975|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082976|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082977|NCT03086135|147718600|SUPERIORITY|||||||0.019|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.019
74082978|NCT03086135|147718600|SUPERIORITY|||||||0.04|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.040
74082979|NCT03086135|147718600|SUPERIORITY|||||||0.037|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.037
74082980|NCT03086135|147718600|SUPERIORITY|||||||0.67|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.67
74082981|NCT03086135|147718600|SUPERIORITY|||||||0.34|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.34
74082982|NCT03086135|147718600|SUPERIORITY|||||||0.0048|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.0048
74082983|NCT03086135|147718600|SUPERIORITY|||||||0.0008|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.0008
74082984|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082985|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Hearing performance: threshold audiometry 6000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082986|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082987|NCT03086135|147718600|SUPERIORITY|||||||0.1|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.10
74082988|NCT03086135|147718600|SUPERIORITY|||||||0.0007|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0007
74082989|NCT03086135|147718600|SUPERIORITY|||||||0.0003|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0003
74082990|NCT03086135|147718600|SUPERIORITY|||||||0.11|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.11
74082991|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082992|NCT03086135|147718600|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0001
74082993|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082994|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082995|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082996|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082997|NCT03086135|147718600|SUPERIORITY|||||||0.8|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||0.80
74082998|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74082999|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74083000|NCT03086135|147718600|SUPERIORITY|||||||0.001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||0.0010
74083001|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74083002|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74083003|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
73836866|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.69|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.69|
74083004|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74083005|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74083006|NCT03086135|147718600|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
74083007|NCT03086135|147718601|SUPERIORITY|||||||0.51|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.51
74083008|NCT03086135|147718601|SUPERIORITY|||||||0.021|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.021
74083009|NCT03086135|147718601|SUPERIORITY|||||||0.29|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.29
74083010|NCT03086135|147718601|SUPERIORITY|||||||0.18|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.18
74083011|NCT03086135|147718601|SUPERIORITY|||||||0.017|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.017
74083012|NCT03086135|147718601|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.16
74083013|NCT03086135|147718601|SUPERIORITY|||||||0.0051|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.0051
74083014|NCT03086135|147718601|SUPERIORITY|||||||0.021|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.021
74083015|NCT03086135|147718601|SUPERIORITY|||||||0.56|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.56
74083016|NCT03086135|147718601|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||<0.0001
74083017|NCT03086135|147718601|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||<0.0001
74083018|NCT03086135|147718601|SUPERIORITY|||||||0.041|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||Speech in quiet at 80dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||0.041
74083019|NCT03086135|147718602|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 4 weeks vs reference device BP110 on softband at visit 1.||||<0.0001
74083020|NCT03086135|147718602|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 3 months vs reference device BP110 on softband at visit 1.||||<0.0001
74083021|NCT03086135|147718602|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 6 months vs reference device BP110 on softband at visit 1.||||<0.0001
74083022|NCT03086135|147718602|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 12 months vs reference device BP110 on softband at visit 1.||||<0.0001
74083023|NCT01023061|147718618|SUPERIORITY||Median Difference (Final Values)|0.74|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.01
74083024|NCT04556734|147718624|OTHER|F-test|LS Mean Difference|-14.14||||0.2579|TWO_SIDED|95.0|-38.933|10.648|||Mixed Models Analysis|||Mixed model for repeated measurements (MMRM) was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||10.648|-38.933|0.2579
74083025|NCT04556734|147718624|OTHER|F-test|LS Mean Difference|-21.79||||0.0592|TWO_SIDED|95.0|-44.446|0.871|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||0.871|-44.446|0.0592
74083026|NCT04556734|147718625|OTHER|F-test|Least square (LS) Mean Difference|-9.23||||0.1283|TWO_SIDED|95.0|-21.217|2.748|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||2.748|-21.217|0.1283
74083027|NCT04556734|147718625|OTHER|F-test|LS Mean Difference|-8.99||||0.1057|TWO_SIDED|95.0|-19.936|1.962|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||1.962|-19.936|0.1057
74083028|NCT04556734|147718626|OTHER||Response rate difference|11.5||||0.4067|TWO_SIDED|95.0|-14.22|37.31||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||37.31|-14.22|0.4067
74083029|NCT04556734|147718626|OTHER||Response rate difference|17.5||||0.2171|TWO_SIDED|95.0|-8.23|43.19||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo||43.19|-8.23|0.2171
74083030|NCT04556734|147718626|OTHER||Response rate difference|-0.8||||0.9425|TWO_SIDED|95.0|-23.18|21.48||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||21.48|-23.18|0.9425
74083031|NCT04556734|147718626|OTHER||Response rate difference|8.9||||0.4959|TWO_SIDED|95.0|-15.19|32.94||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo||32.94|-15.19|0.4959
74083032|NCT04556734|147718626|OTHER||Response rate difference|5.6||||0.3576|TWO_SIDED|95.0|-5.39|16.59||P-values are based on the comparison of Etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||16.59|-5.39|0.3576
74083033|NCT04556734|147718626|OTHER||Response rate difference|8.3||||0.2904|TWO_SIDED|95.0|-3.43|20.12||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo.||20.12|-3.43|0.2904
74083034|NCT02466087|147718629|OTHER||diiference in differences|1.5|||||TWO_SIDED|95.0|||||Regression, Linear|||||||
74083035|NCT00202839|147718651|SUPERIORITY_OR_OTHER|||||||0.1651||95.0|||||Chi-squared|||||||0.1651
74083036|NCT01390415|147718655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0374||95.0|||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6||||0.0374
74083037|NCT01390415|147718656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0566||95.0|||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6||||0.0566
74083038|NCT02856594|147718664|SUPERIORITY||Odds Ratio (OR)|0.32||||0.029|TWO_SIDED|95.0|0.1|0.83|||Regression, Logistic|||||0.83|0.10|0.029
74083039|NCT02856594|147718666|SUPERIORITY||Odds Ratio (OR)|0.96||||0.24|TWO_SIDED|95.0|0.89|1.03|||Regression, Linear|||||1.03|0.89|0.24
74083040|NCT04281472|147718674|SUPERIORITY||Hazard Ratio (HR)|0.394|||||TWO_SIDED|95.0|0.253|0.614||||||||0.614|0.253|
74083041|NCT05053360|147718722|SUPERIORITY||Odds Ratio (OR)|2.87||||0.019|TWO_SIDED|95.0|1.19|6.93|||Regression, Logistic|||HIGH PAIN = score over 6 on a 0-10 pain scale (higher number indicating higher pain)||6.93|1.19|.019
74083042|NCT05053360|147718723|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.0002|TWO_SIDED|95.0|-3.47|-1.09|||ANCOVA|||||-1.09|-3.47|.0002
74083043|NCT05004649|147718731|OTHER|||||||0.024356||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.024356
74083044|NCT05004649|147718731|OTHER|||||||0.040382||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.040382
74083045|NCT05004649|147718731|OTHER|||||||0.90161||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.90161
74083046|NCT01717313|147718732|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior antihyperglycemic agent (AHA) therapy status, interaction of time by treatment, and time by prior AHA therapy status||||-0.19|-0.59|<0.001
74083047|NCT01717313|147718733|SUPERIORITY_OR_OTHER||Differences in percentages vs. placebo|-8.2|||||TWO_SIDED|95.0|-18.8|2.6||||||||2.6|-18.8|
74083048|NCT01717313|147718734|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|0.6|||||TWO_SIDED|95.0|-3.1|4.5||||||||4.5|-3.1|
74083049|NCT01717313|147718735|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|-5.8|||||TWO_SIDED|95.0|-16.4|4.9||||||||4.9|-16.4|
73836867|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.49|0.9||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.90|0.49|
74022070|NCT03093402|147596785|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.39|TWO_SIDED|95.0|-4.8|8.7||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for High JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||8.7|-4.8|0.390
74083050|NCT01717313|147718736|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|0.6|||||TWO_SIDED|95.0|-3.5|4.8||||||||4.8|-3.5|
74022071|NCT03093402|147596785|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.39|TWO_SIDED|95.0|-4.9|8.2||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for Medium JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||8.2|-4.9|0.390
74022072|NCT03093402|147596785|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.39|TWO_SIDED|95.0|-8.6|4.6||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for Low JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||4.6|-8.6|0.390
74022073|NCT03093402|147596786|SUPERIORITY||Median Difference (Final Values)|0.7||||0.556|TWO_SIDED|95.0|-1.6|3.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for High JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||3.0|-1.6|0.556
74022074|NCT03093402|147596786|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.556|TWO_SIDED|95.0|-2.5|2.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each JBT-101 cohort versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for Medium JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||2.0|-2.5|0.556
74022075|NCT03093402|147596786|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.556|TWO_SIDED|95.0|-3.1|1.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for High JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||1.4|-3.1|0.556
74022076|NCT03093402|147596787|SUPERIORITY|||||||0.669|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 29.||||0.669
74022077|NCT03093402|147596787|SUPERIORITY|||||||0.432|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 57.||||0.432
74083051|NCT01717313|147718737|SUPERIORITY_OR_OTHER||Between-group rate difference|20.3|||<|0.001|TWO_SIDED|95.0|10.5|29.8|||Miettinen & Nurminen method|||||29.8|10.5|<0.001
74083052|NCT01717313|147718738|SUPERIORITY_OR_OTHER||Between-group rate difference|11.4||||0.001|TWO_SIDED|95.0|4.8|18.6|||Miettinen & Nurminen method|||||18.6|4.8|0.001
74083053|NCT01717313|147718739|SUPERIORITY_OR_OTHER||Difference in the least squares means|-10.3||||0.036|TWO_SIDED|95.0|-19.9|-0.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-0.7|-19.9|0.036
74083054|NCT01717313|147718740|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.6||||0.177|TWO_SIDED|95.0|-28.6|5.3|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||5.3|-28.6|0.177
74083055|NCT01717313|147718745|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.53|||<|0.001|TWO_SIDED|95.0|-0.75|-0.32|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-0.32|-0.75|<0.001
74083056|NCT01717313|147718746|SUPERIORITY_OR_OTHER||Difference in the least squares means|-13.2||||0.014|TWO_SIDED|95.0|-23.7|-2.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-2.7|-23.7|0.014
74083057|NCT01717313|147718747|SUPERIORITY_OR_OTHER||Difference in the least squares means|-20.5||||0.031|TWO_SIDED|95.0|-39.0|-1.9|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-1.9|-39.0|0.031
74083058|NCT02654145|147718755|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.13|-0.66||p-value is for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.|||-0.66|-1.13|<0.001
74083059|NCT02654145|147718755|SUPERIORITY||Mean Difference (Final Values)|-1.34|||<|0.001|TWO_SIDED|95.0|-1.68|-1.0||p- value for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used Xolair.|||-1.00|-1.68|<0.001
74083060|NCT02654145|147718757|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.28|0.47|||Generalised Estimating Equations||Analysis performed using generalized estimating equation (GEE) model assuming a negative binomial distribution with a covariate of treatment period (pre-treatment , on- and off-treatment), logarithm of time as an offset variable|||0.47|0.28|<0.001
74083061|NCT00835588|147718761|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|88.8||||||90.0|82.7|95.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||95.4|82.7|
74083062|NCT00835588|147718762|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|93.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|93.4|
74083063|NCT00835588|147718763|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|91.6|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.8|91.6|
74083064|NCT01943435|147718765|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|0.3||||0.73|TWO_SIDED|95.0|-1.5|2.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||2.2|-1.5|0.73
74083065|NCT01943435|147718765|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|-2.1||||0.02|TWO_SIDED|95.0|-3.9|-0.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||-0.3|-3.9|0.02
74083066|NCT01943435|147718765|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|2.4||||0.01|TWO_SIDED|95.0|0.6|4.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||4.3|0.6|0.01
74083067|NCT01943435|147718766|SUPERIORITY||Mean Difference (Final Values)|87.0||||0.29|TWO_SIDED|95.0|-75.2|249.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||249.2|-75.2|0.29
74083068|NCT01943435|147718766|SUPERIORITY||Mean Difference (Final Values)|129.7||||0.1|TWO_SIDED|95.0|-27.2|286.6|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||286.6|-27.2|0.10
74083069|NCT01943435|147718766|SUPERIORITY||Mean Difference (Final Values)|-42.7||||0.61|TWO_SIDED|95.0|-205.4|120.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||120.0|-205.4|0.61
74083070|NCT01943435|147718767|SUPERIORITY||Mean Difference (Final Values)|30.5||||0.03|TWO_SIDED|95.0|3.1|57.9|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||57.9|3.1|0.03
74083071|NCT01943435|147718767|SUPERIORITY||Mean Difference (Final Values)|18.7||||0.16|TWO_SIDED|95.0|-7.6|45.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||45.0|-7.6|0.16
74083072|NCT01943435|147718767|SUPERIORITY||Mean Difference (Final Values)|11.8||||0.4|TWO_SIDED|95.0|-15.6|39.1|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||39.1|-15.6|0.40
74083073|NCT01196390|147718783|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.85|TWO_SIDED|95.0|0.69|1.36|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation arm|Assuming a median DFS time of 15 months (Arm 2), hypothesized increase in DFS corresponding to median DFS time of 25 months (Arm 1). Assuming an exponential distribution and constant hazards, 183 HER2-positive participants accrued over 5 years and followed for 3 years would result in 162 disease-free survival events and provide 90% statistical power to detect this difference with a 2-sided α of 0.05 and 2 interim analyses. See Limitations and Caveats section.||1.36|0.69|0.85
74083074|NCT01196390|147718784|SUPERIORITY|||||||0.71|||||||Chi-squared|Two-sided significance level = 0.05||||||0.71
74083075|NCT01196390|147718785|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.69|1.47|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation arm|||1.47|0.69|0.95
74083076|NCT01196390|147718787|SUPERIORITY|||||||0.39||||||One-side significance level = 0.05|Chi-squared|||6-8 weeks||||0.39
74083077|NCT01196390|147718787|SUPERIORITY|||||||0.78||||||One-side significance level = 0.05|Chi-squared|||1 year||||0.78
74083078|NCT01196390|147718787|SUPERIORITY|||||||0.28||||||One-side significance level = 0.05|Chi-squared|||2 years||||0.28
74083079|NCT01196390|147718790|SUPERIORITY||Odds Ratio (OR)|2.35||||0.021|TWO_SIDED|95.0|1.13|4.86|||Regression, Logistic|||Logistic regression was used to model the association of treatment arm (Arm 1 vs. 2 \[reference level(RL)\]), T stage (T3 vs.T1,T2 \[RL\]), Zubrod (1,2 vs. 0 \[RL\]), gender (male vs. female \[RL\]), presence of adenopathy (yes vs. no \[RL\]), and age (≥ 60 vs. \<60 \[RL\]) with the occurrence of any cardiac AE, using backwards step-wise model selection requiring p≤0.05 for a covariate to remain in the model. Final model covariates are reported. Age is reported here. No other covariates reported.||4.86|1.13|0.021
74083080|NCT04610580|147718791|OTHER||Geometric Least Square Mean Ratio (%)|95.0|||||TWO_SIDED|90.0|82.1|110.0||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using analysis of variance (ANOVA) statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||110.0|82.1|
74083081|NCT04610580|147718792|OTHER||Geometric Least Square Mean Ratio (%)|96.243|||||TWO_SIDED|90.0|86.384|107.227||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||107.227|86.384|
74083082|NCT04610580|147718793|OTHER||Geometric Least Square Mean Ratio (%)|94.9|||||TWO_SIDED|90.0|81.6|110.5||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||110.5|81.6|
74083083|NCT04610580|147718794|OTHER||Geometric Least Square Mean Ratio (%)|101.2|||||TWO_SIDED|90.0|70.6|145.1||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||145.1|70.6|
74083084|NCT04610580|147718795|OTHER||Geometric Least Square Mean Ratio (%)|99.1|||||TWO_SIDED|90.0|89.3|109.9||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||109.9|89.3|
74083085|NCT01097694|147718801|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||"Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed.~The target enrollment was 60 assuming 10% drop-out for 54 completions which gave us 80% power to detect a doubling-dose change in PC20."||||<0.05
74083086|NCT01097694|147718802|SUPERIORITY||||||<|0.05|||||||Regression, Linear|Adjusted for baseline.||||||<0.05
74083087|NCT01097694|147718803|SUPERIORITY|||||||0.12|||||||Regression, Linear|Adjusted for baseline.||||||0.12
74083088|NCT01097694|147718804|SUPERIORITY|||||||0.1|||||||Regression, Linear|Adjusted for baseline.||||||0.10
74083089|NCT01097694|147718805|SUPERIORITY|||||||0.36|||||||Poisson regression model|||||||0.36
74083090|NCT01097694|147718806|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|adjusted for baseline values||For FEV1 we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.||||<0.05
74083091|NCT01097694|147718807|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|Adjusted for baseline.||For FEV1% we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.||||0.06
74083092|NCT01097694|147718808|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|Adjusted for baseline||||||0.38
74083093|NCT01097694|147718809|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|Adjusted for baseline.||||||0.31
74083094|NCT01097694|147718810|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline||||||0.11
74083095|NCT01097694|147718811|SUPERIORITY|||||||0.31|||||||Regression, Linear|Adjusted for baseline.||||||0.31
74083096|NCT01097694|147718812|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline||||||0.11
74083097|NCT01097694|147718813|SUPERIORITY|||||||0.62|||||||Regression, Linear|Adjusted for baseline.||||||0.62
74083098|NCT01097694|147718814|SUPERIORITY|||||||0.57|||||||Regression, Linear|Adjusted for baseline.||||||0.57
74083099|NCT01097694|147718815|SUPERIORITY|||||||0.15|||||||Regression, Linear|Adjusted for baseline||||||0.15
74083100|NCT01097694|147718816|SUPERIORITY|||||||0.33|||||||Regression, Linear|Adjusted for baseline.||||||0.33
74083101|NCT01097694|147718817|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline.||||||0.11
73836868|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.55|1.01||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.01|0.55|
74083102|NCT01097694|147718818|SUPERIORITY|||||||0.07|||||||Regression, Linear|Adjusted for baseline.||||||0.07
74083103|NCT01097694|147718819|SUPERIORITY|||||||0.94|||||||Regression, Linear|Adjusted for baseline.||||||0.94
74083104|NCT01097694|147718820|SUPERIORITY|||||||0.13|||||||Regression, Linear|Adjusted for baseline||||||0.13
74083105|NCT01097694|147718821|SUPERIORITY|||||||0.25|||||||Regression, Linear|Adjusted for baseline||||||0.25
74083106|NCT01097694|147718822|SUPERIORITY|||||||0.54|||||||Regression, Linear|Adjusted for baseline.||||||0.54
74083107|NCT01097694|147718823|SUPERIORITY|||||||0.18|||||||Regression, Linear|Adjusted for baseline.||||||0.18
73836869|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.79|1.59||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.59|0.79|
74083108|NCT01097694|147718824|SUPERIORITY|||||||0.56|||||||Regression, Linear|Adjusted for baseline.||||||0.56
74083109|NCT01097694|147718825|SUPERIORITY|||||||0.47|||||||Regression, Linear|Adjusted for baseline.||||||0.47
74083110|NCT02377349|147718837|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-PT antibodies was greater than or equal to (≥) 1.5.|GMC ratio|8.47|||||TWO_SIDED|95.0|7.02|10.2|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||10.2|7.02|
74083111|NCT02377349|147718837|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-FHA antibodies was greater than or equal to (≥) 1.5.|GMC ratio|16.11|||||TWO_SIDED|95.0|13.48|19.24|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||19.24|13.48|
74083112|NCT02377349|147718837|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-PRN antibodies was greater than or equal to (≥) 1.5.|GMC ratio|20.65|||||TWO_SIDED|95.0|15.86|26.88|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||26.88|15.86|
74083113|NCT01993940|147718853|SUPERIORITY_OR_OTHER||Difference|18.9|STANDARD_ERROR_OF_MEAN|4.12|<|0.0001|TWO_SIDED|95.0|10.8|27.0||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.||||27.0|10.8|<0.0001
74083114|NCT01993940|147718854|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|0.92|1.88|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.88|0.92|<0.0001
74083115|NCT01993940|147718855|SUPERIORITY_OR_OTHER||LS Mean Difference|2.17|STANDARD_ERROR_OF_MEAN|0.277|<|0.0001|TWO_SIDED|95.0|1.63|2.71|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||2.71|1.63|<0.0001
74083116|NCT01993940|147718856|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15|STANDARD_ERROR_OF_MEAN|0.232|<|0.0001|TWO_SIDED|95.0|0.7|1.61|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.61|0.70|<0.0001
74083117|NCT01993940|147718857|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.227||0.0011|TWO_SIDED|95.0|0.3|1.19|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.19|0.30|0.0011
74083118|NCT01949532|147718867|SUPERIORITY_OR_OTHER||Ratio of geometric means|132.75|||||TWO_SIDED|90.0|70.6|249.63|||||The point estimates of the geometric mean ratios for the PK parameters were calculated by exponentiation of the differences in the least-squares means between the renal impairment group (test) and participants with normal renal function (reference).|||249.63|70.60|
74083119|NCT01949532|147718868|SUPERIORITY_OR_OTHER||Ratio of geometric means|133.62|||||TWO_SIDED|90.0|70.93|251.73||||||||251.73|70.93|
74083120|NCT02413008|147718899|OTHER|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.1|||||||Wilcoxon (Mann-Whitney)|||"The variations of the levels of FSH after treatment was studied in each women at baseline, week 3 and week12 weeks, the variation of levels between two arms were analysed using a non-parametric test Mann-Whitney-Wilcoxon.~The intra individual variation (differences between the pre study determinations screening and baseline) was compared to the variation between baseline and the values obtained at every study visit."||||0.10
74083121|NCT02413008|147718899|OTHER|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.413|||||||Wilcoxon (Mann-Whitney)|||The variations in the intensities for each one of the symptoms and signs of the vaginal atrophy, after 3 and 12 weeks, in each treatment arm, will be compared using the non-parametric test Mann-Whitney-Wilcoxon.||||0.413
74083122|NCT02413008|147718899|OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
73898344|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.838||0.227|TWO_SIDED|95.0|-2.661|0.633||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.633|-2.661|0.227
74083123|NCT02413008|147718900|OTHER||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 1||||<0.05
74083124|NCT02413008|147718900|OTHER||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 3||||<0.05
74083125|NCT02413008|147718900|OTHER||||||>|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 8||||>0.05
74083126|NCT02413008|147718901|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 1||||>0.05
74083127|NCT02413008|147718901|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 3||||>0.05
74083128|NCT02413008|147718901|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 8||||>0.05
74083129|NCT02413008|147718901|OTHER|||||||0.135|||||||Wilcoxon (Mann-Whitney)|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 12||||0.135
74083130|NCT02413008|147718902|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estriol||||0.043
74083131|NCT02413008|147718902|OTHER|||||||0.649|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estriol||||0.649
74083132|NCT02413008|147718902|OTHER|||||||0.588|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 8 in plasma levels of estriol||||0.588
74083133|NCT02413008|147718902|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12 in plasma levels of estriol||||0.67
74083134|NCT02413008|147718903|OTHER|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estradiol.||||0.342
74083135|NCT02413008|147718903|OTHER|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estradiol.||||0.523
74083136|NCT02413008|147718903|OTHER|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 8||||0.523
73898345|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|6.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74083137|NCT02413008|147718903|OTHER|||||||0.163|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 12||||0.163
74083138|NCT02413008|147718904|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 1||||0.418
74083139|NCT02413008|147718904|OTHER|||||||0.642|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 3||||0.642
74083140|NCT02413008|147718904|OTHER|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 8||||0.175
74083141|NCT02413008|147718904|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 12||||0.084
74083142|NCT02413008|147718905|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 3||||<0.01
74083143|NCT02413008|147718905|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 12||||0.057
74083144|NCT02413008|147718906|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 3||||0.14
74083145|NCT02413008|147718906|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 12||||0.25
74083146|NCT02413008|147718907|OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3||||0.28
74083147|NCT02413008|147718907|OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12||||0.34
74083148|NCT02413008|147718908|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 3||||0.14
74083149|NCT02413008|147718908|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 12||||<0.01
74083150|NCT02413008|147718909|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 3||||0.03
74083151|NCT02413008|147718909|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 12||||0.04
74083152|NCT02413008|147718910|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3||||<0.001
74083153|NCT02413008|147718910|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa betweeen baseline and week 12||||<0.01
74083154|NCT02413008|147718911|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3||||0.13
74083155|NCT02413008|147718911|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 12||||<0.01
74083156|NCT02413008|147718912|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3||||<0.001
74083157|NCT02413008|147718912|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12||||<0.001
74083158|NCT02413008|147718913|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 3 and baseline||||<0.001
74083159|NCT02413008|147718913|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 12 and baseline||||<0.001
74083160|NCT02413008|147718914|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 3||||<0.0001
74083161|NCT02413008|147718914|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 12||||0.006
74083162|NCT04387617|147718915|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_DEVIATION|2.6||0.5|TWO_SIDED|95.0|-0.8|1.6|||t-test, 2 sided|||||1.6|-0.8|0.5
74083163|NCT02614196|147718933|SUPERIORITY||LSMean Difference|-2.02|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.55|-1.48|||Mixed Models Analysis|||||-1.48|-2.55|<.001
74083164|NCT02614196|147718933|SUPERIORITY||LSMean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.44|-1.36|||Mixed Models Analysis|||||-1.36|-2.44|<.001
74083165|NCT02614196|147718934|SUPERIORITY||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|2.03|3.32||||||Reduction from Baseline ≥50%||3.32|2.03|
74083166|NCT02614196|147718934|SUPERIORITY||Odds Ratio (OR)|2.31|||||TWO_SIDED|95.0|1.81|2.96||||||Reduction from Baseline ≥50%||2.96|1.81|
74083167|NCT02614196|147718934|SUPERIORITY||Odds Ratio (OR)|2.34|||||TWO_SIDED|95.0|1.78|3.06||||||Reduction from Baseline ≥75%||3.06|1.78|
74083168|NCT02614196|147718934|SUPERIORITY||Odds Ratio (OR)|2.42|||||TWO_SIDED|95.0|1.84|3.17||||||Reduction from Baseline ≥75%||3.17|1.84|
74083169|NCT02614196|147718934|SUPERIORITY||Odds Ratio (OR)|2.16|||||TWO_SIDED|95.0|1.5|3.12||||||Reduction from Baseline ≥100%||3.12|1.50|
74083170|NCT02614196|147718934|SUPERIORITY||Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.87|3.81||||||Reduction from Baseline ≥100%||3.81|1.87|
74083171|NCT02614196|147718935|SUPERIORITY||LSMean Difference|8.82|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|6.33|11.31|||Mixed Models Analysis|||||11.31|6.33|<.001
74083172|NCT02614196|147718935|SUPERIORITY||LSMean Difference|7.39|STANDARD_ERROR_OF_MEAN|1.28|<|0.001|TWO_SIDED|95.0|4.88|9.9|||Mixed Models Analysis|||||9.90|4.88|<.001
74083173|NCT02614196|147718936|SUPERIORITY||LSMean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.29|-1.36|||Mixed Models Analysis|||||-1.36|-2.29|<.001
74083174|NCT02614196|147718936|SUPERIORITY||LSMean Difference|-1.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.25|-1.31|||Mixed Models Analysis|||||-1.31|-2.25|<.001
74083175|NCT02614196|147718937|SUPERIORITY||LSMean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.09||0.002|TWO_SIDED|95.0|-0.47|-0.11|||Mixed Models Analysis|||||-0.11|-0.47|.002
74083176|NCT02614196|147718937|SUPERIORITY||LSMean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.09||0.012|TWO_SIDED|95.0|-0.41|-0.05|||Mixed Models Analysis|||||-0.05|-0.41|.012
74083177|NCT02614196|147718938|SUPERIORITY||LSMean Difference|-15.19|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-20.27|-10.11|||Mixed Models Analysis|||||-10.11|-20.27|<.001
74083178|NCT02614196|147718938|SUPERIORITY||LSMean Difference|-13.56|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-18.67|-8.44|||Mixed Models Analysis|||||-8.44|-18.67|<.001
74083179|NCT02614196|147718939|SUPERIORITY||LSMean Difference|-9.15|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-12.61|-5.69|||Mixed Models Analysis|||||-5.69|-12.61|<.001
74083180|NCT02614196|147718939|SUPERIORITY||LSMean Difference|-8.22|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-11.71|-4.72|||Mixed Models Analysis|||||-4.72|-11.71|<.001
73836870|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.98|1.63||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.63|0.98|
74083181|NCT02614196|147718940|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||TE ADA Positive.||||<.001
74083182|NCT02614196|147718940|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||TE ADA Positive||||<.001
74083183|NCT02627001|147718951|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Ranks|||||||<0.001
74083184|NCT00762411|147718969|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Mixed Models Analysis|||||||0.560
74083185|NCT00762411|147718970|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||Mixed Models Analysis|||||||0.959
74083186|NCT00762411|147718971|SUPERIORITY_OR_OTHER|||||||0.567||95.0|||||Mixed Models Analysis|||||||0.567
74083187|NCT00762411|147718972|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||Mixed Models Analysis|||||||0.199
74083188|NCT00762411|147718973|SUPERIORITY_OR_OTHER|||||||0.294||95.0|||||Mixed Models Analysis|||||||0.294
74083189|NCT00762411|147718974|SUPERIORITY_OR_OTHER|||||||0.477||95.0|||||Mixed Models Analysis|||||||0.477
74083190|NCT00762411|147718975|SUPERIORITY_OR_OTHER|||||||0.673||95.0|||||ANCOVA|||||||0.673
74083191|NCT00762411|147718976|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Mixed Models Analysis|||||||0.622
74083192|NCT00762411|147718977|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Mixed Models Analysis|||||||0.178
74083193|NCT00762411|147718978|SUPERIORITY_OR_OTHER|||||||0.632||95.0|||||Mixed Models Analysis|||||||0.632
74083194|NCT00762411|147718979|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|||||||0.009
74083195|NCT00762411|147718980|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||ANCOVA|||||||0.426
74083196|NCT00762411|147718981|SUPERIORITY_OR_OTHER|||||||0.101||95.0||||This is the p-value for the Right Hippocampal Volume.|ANCOVA|||||||0.101
74083197|NCT00762411|147718981|SUPERIORITY_OR_OTHER|||||||0.772||95.0||||This is the p-value for the Left Hippocampal Volume.|ANCOVA|||||||0.772
74083198|NCT00762411|147718982|SUPERIORITY_OR_OTHER|||||||0.326||95.0|||||ANCOVA|||||||0.326
74083199|NCT00762411|147718983|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||ANCOVA|||||||0.117
74083200|NCT00762411|147718992|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Mixed Models Analysis|||||||0.929
74083201|NCT00762411|147718993|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||Mixed Models Analysis|||||||0.437
74083202|NCT00762411|147718994|SUPERIORITY_OR_OTHER|||||||0.318||95.0|||||ANCOVA|||||||0.318
74083203|NCT00762411|147718995|SUPERIORITY_OR_OTHER|||||||0.417||95.0|||||ANCOVA|||||||0.417
74083204|NCT00762411|147718996|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Mixed Models Analysis|||||||0.805
74083205|NCT00762411|147718997|SUPERIORITY_OR_OTHER|||||||0.893||95.0|||||Mixed Models Analysis|||||||0.893
74083206|NCT01680016|147719042|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|0.84|||||TWO_SIDED|95.0|0.69|1.02|||ANOVA|||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in children aged ≥6 to ≤17 years||1.02|0.69|
73898346|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.859||0.241|TWO_SIDED|95.0|-2.698|0.681||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.681|-2.698|0.241
73898347|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|6.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73959050|NCT02393716|147453914|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Percentage|95.8|||<|0.001|ONE_SIDED|97.5|90.4||||Based on exact binomial distribution|||"The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG."|||90.4|<0.001
73959051|NCT02957539|147453928|SUPERIORITY||Mean Difference (Net)|-4.5|||||TWO_SIDED|97.5|-10.7|1.6|||||Change in weight from baseline to week 32 in the financial rewards arm minus the change in weight from baseline to week 32 in the no rewards arm.|||1.6|-10.7|
73959052|NCT02957539|147453928|SUPERIORITY||Mean Difference (Net)|-5.0|||<|0.025|TWO_SIDED|97.5|-11.1|1.0|||t-test, 2 sided||Change in weight from baseline to week 32 in the non-financial arm minus the change in weight from baseline to week 32 in the no rewards arm|||1|-11.1|<0.025
74083207|NCT01680016|147719043|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|1.09|||||TWO_SIDED|95.0|0.87|1.35|||ANOVA|||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in older adults aged ≥51 years||1.35|0.87|
74083208|NCT02846883|147719078|SUPERIORITY|These power estimates are based on linear regression of regulatory T-cell counts at each time point. These data will be summarized with the mean, median, standard deviation, standard error, minimum and maximum.|Mean Difference (Final Values)|81.0|||<|0.05|TWO_SIDED|95.0||||P value is adjusted for multiple comparisons|Regression, Cox|See above|Estimates for the differences in the secondary endpoints will be used to perform a power estimation using a Monte Carlo simulation method.|The primary statistical evaluation for Aim 1 will focus on the chronologically increasing counts of T-regulatory cells over time following MSC administration in both delivery groups. Using the pattern of increased counts with time and the standard deviation reported by Ito and colleagues in healthy subjects, 36 subjects provides 81.0% power to detect such a change.A p value of \<0.05 will be considered significant.||||<0.05
73898348|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|0.81|STANDARD_ERROR_OF_MEAN|0.958||0.397|TWO_SIDED|95.0|-1.073|2.696||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.696|-1.073|0.397
73959053|NCT02957539|147453929|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|97.5|-0.5|1.8|||||Change in Self Efficacy score from baseline to week 16 in the financial rewards arm minus the change in Self Efficacy score from baseline to week 16 in the no rewards arm.|||1.8|-0.5|
73959054|NCT02957539|147453929|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-0.8|1.5|||||Change in Self Efficacy score from baseline to week 16 in the nonfinancial rewards arm minus the change in Self Efficacy score from baseline to week 16 in the no rewards arm.|||1.5|-0.8|
73959055|NCT02957539|147453930|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|97.5|-1.2|1.4|||||The change in self efficacy from baseline to week 32 in the financial incentive arm minus the change in self efficacy from baseline to week 32 in the no rewards arm|||1.4|-1.2|
73959056|NCT02957539|147453930|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|97.5|-0.9|1.8|||||The change in self efficacy from baseline to week 32 in the nonfinancial incentive arm minus the change in self efficacy from baseline to week 32 in the no rewards arm|||1.8|-.9|
73959057|NCT02957539|147453931|SUPERIORITY||Mean Difference (Net)|1.5|||||TWO_SIDED|97.5|0.2|2.8|||||The change in self efficacy from baseline to week 52 in the financial incentive arm minus the change in self efficacy from baseline to week 52 in the no rewards arm|||2.8|0.2|
73959058|NCT02957539|147453931|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|97.5|0.0|2.3|||||The change in self efficacy from baseline to week 52 in the nonfinancial incentive arm minus the change in self efficacy from baseline to week 52 in the no rewards arm|||2.3|0.0|
73959059|NCT02957539|147453932|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|97.5|-0.4|0.9|||||Change in intrinsic motivation score from baseline to week 16 in the financial rewards arm minus the change in intrinsic motivation score from baseline to week 16 in the no rewards arm.|||0.9|-0.4|
73959060|NCT02957539|147453932|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|97.5|-0.6|0.7|||||Change in intrinsic motivation score from baseline to week 16 in the nonfinancial rewards arm minus the change in intrinsic motivation score from baseline to week 16 in the no rewards arm.|||0.7|-0.6|
73959061|NCT02957539|147453933|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|97.5|-0.2|1.3|||||The change in intrinsic motivation from baseline to week 32 in the financial incentive arm minus the change in intrinsic motivation from baseline to week 32 in the no rewards arm|||1.3|-0.2|
73959062|NCT02957539|147453933|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|97.5|-0.3|1.6|||||The change in intrinsic motivation from baseline to week 32 in the nonfinancial incentive arm minus the change in intrinsic motivation from baseline to week 32 in the no rewards arm|||1.6|-0.3|
73959063|NCT02957539|147453934|SUPERIORITY||Mean Difference (Final Values)|0.5|||||TWO_SIDED|97.5|-0.5|1.5|||||The change in intrinsic motivation from baseline to week 52 in the financial incentive arm minus the change in intrinsic motivation from baseline to week 52 in the no rewards arm|||1.5|-0.5|
73959064|NCT02957539|147453934|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|97.5|-0.8|1.6|||||Incentive Group minus usual care|||1.6|-0.8|
73959065|NCT02957539|147453935|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-2.0|2.6|||||Change in PHQ-8 score from baseline to week 16 in the financial rewards arm minus the change in PHQ-8 score from baseline to week 16 in the no rewards arm.|||2.6|-2.0|
74083209|NCT01863186|147719091|SUPERIORITY|||||||0.0166|||||||Pattern Mixture Model|||Due to the amount of missing data a pattern mixture model (or Jump to Reference) was utilized. The SOWS-Gossop total scores were log transformed. Each subjects available data Days 1-7 were included. The datasets created by the pattern mixture model were analyzed using a Mixed Model Repeated Measures model that included fixed effects for treatment group, baseline, sex, study day (1-7), and treatment group-by-day interaction. The overall estimate for each treatment group were compared.||||0.0166
74083210|NCT01863186|147719091|SUPERIORITY|||||||0.0033|||||||Pattern Mixture Model|||Due to the amount of missing data a pattern mixture model (or Jump to Reference) was utilized. The SOWS-Gossop total scores were log transformed. Each subjects available data Days 1-7 were included. The datasets created by the pattern mixture model were analyzed using a Mixed Model Repeated Measures model that included fixed effects for treatment group, baseline, sex, study day (1-7), and treatment group-by-day interaction. The overall estimate for each treatment group were compared.||||0.0033
74083211|NCT00452348|147719140|SUPERIORITY_OR_OTHER||Least Squares Mean|0.04||||0.09||95.0|-0.01|0.09|||ANCOVA|||||0.09|-0.01|0.090
74083212|NCT00377156|147719188|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-28.2|||<|0.001|TWO_SIDED|90.0|-41.9|-14.4|||Fisher Exact||Cognitive deterioration, the primary end point in evaluable patients at 3 months, was less frequent after Arm I than Arm II (40/63 \[63.5%\] vs 44/48 \[91.7%\],\> respectively. The percent difference was -28.2%; 90% CI, -41.9% to -14.4%; P \< .001).|||-14.4|-41.9|<0.001
74083213|NCT00377156|147719189|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-18.4|||<|0.001|TWO_SIDED|95.0|-29.0|-7.8|||Fisher Exact|||||-7.8|-29.0|<0.001
74083214|NCT00377156|147719190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.9||||0.001|TWO_SIDED|95.0|4.8|19.0|||t-test, 2 sided|||||19.0|4.8|0.001
73836871|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.76|1.27||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.27|0.76|
73959066|NCT02957539|147453935|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|97.5|-1.5|2.9|||||Change in PHQ-9 from week baseline to week 16 in the non-financial incentive group minus the change from week baseline to week 16 in the no rewards group|||2.9|-1.5|
73959067|NCT02957539|147453936|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|97.5|-1.7|4.5|||||The change in PHQ-8 from baseline to week 32 in the financial incentive arm minus the change in PHQ-8 from baseline to week 32 in the no rewards arm|||4.5|-1.7|
73959068|NCT02957539|147453936|SUPERIORITY||Mean Difference (Net)|2.2|||||TWO_SIDED|97.5|-0.7|5.0|||||The change in PHQ-8 from baseline to week 32 in the nonfinancial incentive arm minus the change in PHQ-8 from baseline to week 32 in the no rewards arm|||5.0|-0.7|
73959069|NCT02957539|147453937|SUPERIORITY||Mean Difference (Net)|-1.1|||||TWO_SIDED|97.5|-4.9|2.8|||||Change in PHQ-8 score from baseline to week 52 in the financial rewards arm minus the change in PHQ-8 score from baseline to week 52 in the no rewards arm.|||2.8|-4.9|
73959070|NCT02957539|147453937|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-2.9|3.6|||||The change in PHQ-8 from baseline to week 52 in the nonfinancial incentive arm minus the change in PHQ-8 from baseline to week 52 in the no rewards arm|||3.6|-2.9|
73959071|NCT02957539|147453938|SUPERIORITY||Mean Difference (Net)|-3.2|||||TWO_SIDED|97.5|-7.4|1.0|||||Change in weight from baseline to week 16 in the financial rewards arm minus the change in weight from baseline to week 16 in the no rewards arm.|||1|-7.4|
73959072|NCT02957539|147453938|SUPERIORITY||Mean Difference (Net)|-4.6|||||TWO_SIDED|97.5|-8.7|-0.4|||||Change in weight from baseline to week 16 in the nonfinancial rewards arm minus the change in weight from baseline to week 32 in the no rewards arm.|||-0.4|-8.7|
73959073|NCT02957539|147453939|SUPERIORITY||Mean Difference (Net)|2.4|||||TWO_SIDED|97.5|-6.0|10.7|||||Change in weight from baseline to week 52 in the financial rewards arm minus the change in weight from baseline to week 52 in the no rewards arm.|||10.7|-6|
73959074|NCT02957539|147453939|SUPERIORITY||Mean Difference (Net)|-3.6|||||TWO_SIDED|97.5|-11.2|4.1|||||Change in weight from baseline to week 52 in the nonfinancial rewards arm minus the change in weight from baseline to week 52 in the no rewards arm.|||4.1|-11.2|
73959075|NCT01193153|147453949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.49|||<|0.001|TWO_SIDED|95.0|1.55|3.99|||Log Rank|||All participants: p-value was calculated using log-rank test.||3.99|1.55|<0.001
73959076|NCT01193153|147453949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.38||||0.002|TWO_SIDED|95.0|1.57|7.28|||Regression, Cox|||Monotherapy subset: Hazard ratio and corresponding p-value, and 95% Confidence Interval (CI) were calculated from Cox proportional hazard regression model.||7.28|1.57|0.002
73959077|NCT01193153|147453949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.03||||0.021|TWO_SIDED|95.0|1.11|3.68|||Regression, Cox|||Adjunct therapy subset: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||3.68|1.11|0.021
73959078|NCT01193153|147453949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.82|||<|0.001|TWO_SIDED|95.0|1.7|4.67|||Regression, Cox|||Psychotic Symptoms: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||4.67|1.70|<0.001
73959079|NCT01193153|147453949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.93|||<|0.001|TWO_SIDED|95.0|1.7|5.04|||Regression, Cox|||Mood Symptoms (Any Mood Symptoms):Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||5.04|1.70|<0.001
74083215|NCT00377156|147719191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.4||||0.04|TWO_SIDED|95.0|-74.4|5.5|||Fisher Exact||The incidence of cognitive deterioration was less in Arm I than Arm II at 12 months (6/10 \[60%\] vs 17/18 \[94.4%\]. The percent difference was -34.4% (95% CI: -74.4% to 5.5%; P = .04)|||5.5|-74.4|0.04
74083216|NCT00377156|147719192|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.92|TWO_SIDED|95.0|0.75|1.38|||Regression, Cox|||||1.38|0.75|0.92
74083217|NCT00856349|147719193|SUPERIORITY_OR_OTHER||Increase in % on target (LIA)|13.6|||<|0.0001|||||||McNemar|||LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.||||<0.0001
74083218|NCT00856349|147719193|SUPERIORITY_OR_OTHER||Increase in % on target (SVT Limit)|6.8|||<|0.0001|||||||McNemar|||SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.||||<0.0001
73959080|NCT01193153|147453949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.62||||0.012|TWO_SIDED|95.0|1.32|9.89|||Regression, Cox|||Mood Symptoms (Manic): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||9.89|1.32|0.012
73959081|NCT01193153|147453949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.12||||0.006|TWO_SIDED|95.0|1.39|6.98|||Regression, Cox|||Mood Symptoms (Depressive): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||6.98|1.39|0.006
73959082|NCT01193153|147453949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.93||||0.238|TWO_SIDED|95.0|0.65|5.78|||Regression, Cox|||Mood Symptoms (Mixed): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||5.78|0.65|0.238
73959083|NCT01193153|147453950|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|1.33||0.014|TWO_SIDED|95.0|0.68|5.95||P-value based on change from DB baseline in PSP score and was analyzed using mixed-model repeated measures analysis of covariance based on observed data; within-participant repeated measures were modeled using an unstructured covariance matrix.|MMRM ANCOVA|||The null hypothesis is that there is no difference in the mean of the PSP total score between the two treatment groups.||5.95|0.68|0.014
73959084|NCT01193153|147453952|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.5|||<|0.001|TWO_SIDED|95.0|1.94|7.15||Change at Endpoint (Week 64/LOCF)|ANCOVA|||||7.15|1.94|<0.001
73959085|NCT01256034|147454016|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
73959086|NCT01157182|147454028|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.94|||||TWO_SIDED|90.0|97.63|108.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.55|97.63|
73959087|NCT01157182|147454029|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.4|||||TWO_SIDED|90.0|95.15|101.76|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.76|95.15|
73959088|NCT01157182|147454030|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.73|||||TWO_SIDED|90.0|95.33|102.26|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.26|95.33|
73959089|NCT01157182|147454031|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.51|||||TWO_SIDED|90.0|88.64|96.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||96.55|88.64|
73959090|NCT01157182|147454032|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.66|||||TWO_SIDED|90.0|92.6|98.81|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.81|92.60|
73959091|NCT01157182|147454033|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.71|||||TWO_SIDED|90.0|92.62|98.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.91|92.62|
73959092|NCT01157182|147454034|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.41|||||TWO_SIDED|90.0|88.65|96.33|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||96.33|88.65|
74083219|NCT00856349|147719193|SUPERIORITY_OR_OTHER||Increase in % on target (VF NID PP)|9.0|||<|0.0001|||||||McNemar|||VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.||||<0.0001
74083220|NCT00856349|147719193|SUPERIORITY_OR_OTHER||Increase in % on target (VF NID SP)|3.5||||0.0116|||||||McNemar|||VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.||||0.0116
74083221|NCT00856349|147719193|SUPERIORITY_OR_OTHER||Increase in % on target (Wavelet)|9.5|||<|0.0001|||||||McNemar|||Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.||||<0.0001
73959093|NCT01157182|147454035|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.67|||||TWO_SIDED|90.0|92.68|98.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.77|92.68|
73959094|NCT01157182|147454036|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.73|||||TWO_SIDED|90.0|92.68|98.88|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.88|92.68|
73959095|NCT01157182|147454037|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.21|||||TWO_SIDED|90.0|84.62|98.31|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.31|84.62|
73959096|NCT01157182|147454038|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.11|||||TWO_SIDED|90.0|89.04|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.47|89.04|
74083222|NCT00856349|147719193|SUPERIORITY_OR_OTHER||Increase in % on target (PR Logic)|3.2|||<|0.0001|||||||McNemar|||PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds.||||<0.0001
73959097|NCT01157182|147454039|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.48|||||TWO_SIDED|90.0|90.7|104.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.76|90.70|
73959098|NCT01157182|147454040|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||TWO_SIDED|90.0|89.78|98.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.81|89.78|
73959099|NCT01157182|147454041|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.99|||||TWO_SIDED|90.0|92.73|99.36|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.36|92.73|
73959100|NCT01157182|147454042|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.22|||||TWO_SIDED|90.0|93.62|100.96|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.96|93.62|
73959101|NCT01157182|147454043|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.73|||||TWO_SIDED|90.0|84.46|99.62|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.62|84.46|
73959102|NCT01157182|147454044|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.47|||||TWO_SIDED|90.0|88.37|103.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.14|88.37|
73959103|NCT01157182|147454045|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.63|||||TWO_SIDED|90.0|88.1|103.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.81|88.10|
74083223|NCT02725515|147719199|SUPERIORITY||Risk Difference (RD)|13.4||||0.183|TWO_SIDED|95.0|-6.6|32.6|||Barnard's Unconditional Exact Test P-val|||||32.6|-6.6|0.1830
74083224|NCT02725515|147719200|SUPERIORITY||Risk Difference (RD)|17.5||||0.1075|TWO_SIDED|95.0|-3.7|37.3|||Barnard's Unconditional Exact Test P-val|||||37.3|-3.7|0.1075
73959104|NCT01157182|147454046|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.15|||||TWO_SIDED|90.0|89.56|98.98|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.98|89.56|
73959105|NCT01157182|147454047|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.01|||||TWO_SIDED|90.0|92.14|100.04|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.04|92.14|
73959106|NCT01157182|147454048|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.75|||||TWO_SIDED|90.0|92.75|100.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.93|92.75|
73959107|NCT00716144|147454049|SUPERIORITY_OR_OTHER|||||||0.884|||||||Cochran-Armitage Trend Test|||||||0.884
73959108|NCT00716144|147454050|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3||||1.000
73959109|NCT00716144|147454050|SUPERIORITY_OR_OTHER|||||||0.604|||||||Cochran-Armitage Trend Test|||At Visit 4||||0.604
73959110|NCT00716144|147454050|SUPERIORITY_OR_OTHER|||||||0.463|||||||Cochran-Armitage Trend Test|||At Visit 5||||0.463
73959111|NCT00716144|147454050|SUPERIORITY_OR_OTHER|||||||0.042|||||||Cochran-Armitage Trend Test|||At Visit 6||||0.042
73959112|NCT00716144|147454050|SUPERIORITY_OR_OTHER|||||||0.034|||||||Cochran-Armitage Trend Test|||At Visit 7||||0.034
73959113|NCT00716144|147454050|SUPERIORITY_OR_OTHER|||||||0.019|||||||Cochran-Armitage Trend Test|||At Visit 8||||0.019
73959114|NCT00716144|147454052|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3||||1.000
73959115|NCT00716144|147454052|SUPERIORITY_OR_OTHER|||||||0.673|||||||Cochran-Armitage Trend Test|||At Visit 4||||0.673
73959116|NCT00716144|147454052|SUPERIORITY_OR_OTHER|||||||0.55|||||||Cochran-Armitage Trend Test|||At Visit 5||||0.550
73959117|NCT00716144|147454052|SUPERIORITY_OR_OTHER|||||||0.721|||||||Cochran-Armitage Trend Test|||At Visit 7||||0.721
73959118|NCT00716144|147454052|SUPERIORITY_OR_OTHER|||||||0.03|||||||Cochran-Armitage Trend Test|||At Visit 8||||0.030
73959119|NCT02950558|147454053|OTHER|||||||0.1269|||||||Wilcoxon (Mann-Whitney)|||||||0.1269
74083225|NCT02725515|147719201|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0252|TWO_SIDED|95.0|0.3|0.92|||Log Rank|||||0.92|0.30|0.0252
73959120|NCT02950558|147454054|OTHER|||||||0.8808|||||||Wilcoxon (Mann-Whitney)|||||||0.8808
73959121|NCT02950558|147454055|OTHER|||||||0.0382|||||||Wilcoxon (Mann-Whitney)|||||||0.0382
73959122|NCT02950558|147454056|OTHER|||||||0.4696|||||||Wilcoxon (Mann-Whitney)|||||||0.4696
73959123|NCT02950558|147454057|OTHER|||||||0.1818|||||||Fisher Exact|||||||0.1818
73959124|NCT02498769|147454099|OTHER||Hazard Ratio (HR)|0.69||||0.18|TWO_SIDED|95.0|0.41|1.19|||Regression, Cox|||||1.19|0.41|0.18
73959125|NCT02498769|147454100|OTHER||Odds Ratio (OR)|0.63||||0.19|TWO_SIDED|95.0|0.31|1.27|||Regression, Logistic|||||1.27|0.31|0.19
73959126|NCT02498769|147454101|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||ICU length of stay hours||||.16
73959127|NCT02498769|147454101|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Hospital LOS||||.51
73959128|NCT02498769|147454102|OTHER|||||||0.97|||||||Chi-squared|||||||.97
73959129|NCT00367055|147454109|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||p value is for Total AUC(0-10 min)|Van Elteren|||||||0.376
73959130|NCT00367055|147454109|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||p value is for Incremental AUC(0-10 min)|Van Elteren|||||||0.990
73959131|NCT04470193|147454119|SUPERIORITY|We approached 62 subjects to get a sample size of 50 participants, allowing up to 16% attrition, to estimate the proportions of patients satisfying dropout of 0.13 to within margins of error (half-widths of 90% Cis). The 50 evaluable subjects were used to estimate the SD of QoL, with a margin of error of ∼20%. The sample size also allowed us to provide provisional estimates of the effect size for the QoL outcome to within a margin of error of ±7.1 points, assuming a true SD of 15 points.|||||>|0.05|||||||generalized estimating equation model|||We used a generalized estimating equation model for repeated assessments, with a common unstructured residual covariance matrix to account for correlation in repeated measurements in the same patient, to compare QoL total score at baseline, 1 month, and 3 months between the groups. We hypothesized that MyChildCMC users would have better outcomes for the child (higher QoL, fewer ED and/or hospital use and hospital days) and parent (higher satisfaction with child's care).||||>0.05
73959132|NCT04470193|147454120|SUPERIORITY||Risk Ratio (RR)|1.05||||0.882|TWO_SIDED|95.0|0.58|1.88|||Mixed Models Analysis|||||1.88|0.58|0.882
73959133|NCT04470193|147454121|SUPERIORITY||Risk Ratio (RR)|0.49|||<|0.001|TWO_SIDED|95.0|0.39|0.62|||Mixed Models Analysis|||||0.62|0.39|<0.001
73959134|NCT04470193|147454122|SUPERIORITY||Risk Ratio (RR)|1.11||||0.035|TWO_SIDED|95.0|1.01|1.22|||Mixed Models Analysis|||||1.22|1.01|0.035
73959135|NCT02517307|147454136|OTHER|||||||0.136|||||||Mixed Models Analysis|||We compared the effects of intralipid on Rd in controls subjects versus subjects with a FAOD by mixed-effect models. Factors were group (control or FAOD) treatment (glycerol or intralipid) and the interaction of those factors. The hypothesis was intralipid would decrease Rd in controls but not in subjects with an FAOD.||||0.136
73959136|NCT02517307|147454137|OTHER|We analyzed the data with a mixed model looking at the effect of group (control vs FAOD) and treatment (glycerol vs intralipid) and their interaction.||||||0.011|||||||Mixed Models Analysis|||We tested if intralipid did not suppress endogenous glucose production or Ra as much as glycerol in controls compared to subjects with an FAOD.||||0.011
74083226|NCT02898740|147719217|OTHER||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|95.0|-6.8|0.0|||Mixed Models Analysis|models were adjusted for age|treatment difference = Exercise - Health Education|||-0.0|-6.8|<0.05
73959137|NCT00361283|147454170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-111.0|STANDARD_ERROR_OF_MEAN|76.7||0.15|TWO_SIDED|95.0|-264.0|42.0||No confounders were controlled for as each person is his/her own control.|t-test, 2 sided|||The study in healthy volunteers was to compare levels at baseline to 16 weeks in ENA-78, a cytokine. The one sample t-test was used to obtain the result.||42|-264|0.15
73959138|NCT05147233|147454176|SUPERIORITY||Difference in Percentages|33.2|||<|0.0001|TWO_SIDED|95.0|21.5|44.9|||Wald test|||||44.9|21.5|<0.0001
73959139|NCT05147233|147454177|SUPERIORITY||Difference in Percentages|23.5|||<|0.0001|TWO_SIDED|95.0|11.7|35.3|||Wald test|||||35.3|11.7|<0.0001
73959140|NCT04517864|147454179|SUPERIORITY||Least Squares Mean Difference|0.021|STANDARD_ERROR_OF_MEAN|0.0382|||TWO_SIDED|95.0|-0.056|0.097||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear Mixed-effects Model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.097|-0.056|
73959141|NCT04517864|147454180|SUPERIORITY||Least Squares Mean Difference|0.009|STANDARD_ERROR_OF_MEAN|0.0307|||TWO_SIDED|95.0|-0.052|0.07||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.070|-0.052|
73959142|NCT04517864|147454181|SUPERIORITY||Least Squares Mean Difference|-0.006|STANDARD_ERROR_OF_MEAN|0.0297|||TWO_SIDED|95.0|-0.065|0.053||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear Mixed-effects Model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.053|-0.065|
73959143|NCT04517864|147454183|SUPERIORITY||Least Squares Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.0235|||TWO_SIDED|95.0|-0.005|0.088||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.088|-0.005|
73959144|NCT04517864|147454189|SUPERIORITY||Least Squares Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0224|||TWO_SIDED|95.0|-0.059|0.03||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 6||0.030|-0.059|
73959145|NCT04517864|147454189|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.0236|||TWO_SIDED|95.0|-0.107|-0.012||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 9||-0.012|-0.107|
73959146|NCT04517864|147454191|SUPERIORITY||Least Squares Mean Difference|-0.028|STANDARD_ERROR_OF_MEAN|0.0242|||TWO_SIDED|95.0|-0.076|0.02||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 6||0.020|-0.076|
73959147|NCT04517864|147454191|SUPERIORITY||Least Squares Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0261|||TWO_SIDED|95.0|-0.049|0.056||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 9||0.056|-0.049|
73959148|NCT01227278|147454261|SUPERIORITY_OR_OTHER||Rate ratio|1.03||||0.941|TWO_SIDED|95.0|0.67|1.58|||Van Elteren Test|Day 1 to 393: Van Elteren test was used to compare the two arms.|95 percent (%) confidence interval (CI) for rate ratio was based on normal approximation assuming rate with Poisson distribution.|||1.58|0.67|0.941
73959149|NCT04035668|147454271|SUPERIORITY||Mean Difference (Final Values)|-2.86||||0.002|TWO_SIDED|95.0|-4.71|-1.01||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|||-1.01|-4.71|0.002
73959150|NCT04035668|147454271|OTHER||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.24|1.25|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|||1.25|-3.24|
73959151|NCT04035668|147454272|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.065|TWO_SIDED|95.0|-2.29|0.3||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.30|-2.29|0.065
73959152|NCT04035668|147454272|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.01|TWO_SIDED|95.0|-3.24|-0.29||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||-0.29|-3.24|0.010
73959153|NCT04035668|147454272|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.289|TWO_SIDED|95.0|-2.17|1.22||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||1.22|-2.17|0.289
73959154|NCT04035668|147454272|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.093|TWO_SIDED|95.0|-2.97|0.59||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||0.59|-2.97|0.093
74083227|NCT02733627|147719266|OTHER||Slope|3.8266|STANDARD_ERROR_OF_MEAN|0.2967|||TWO_SIDED|95.0|3.2155|4.4376||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.4376|3.2155|
73959155|NCT04035668|147454272|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.094|TWO_SIDED|95.0|-2.84|0.57||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||0.57|-2.84|0.094
73959156|NCT04035668|147454272|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.012|TWO_SIDED|95.0|-3.71|-0.28||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|-0.28|-3.71|0.012
73959157|NCT04035668|147454272|OTHER||Mean Difference (Final Values)|-0.63|||||TWO_SIDED|95.0|-2.1|0.84|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||0.84|-2.10|
74083228|NCT02733627|147719267|OTHER||Slope|4.181|STANDARD_ERROR_OF_MEAN|0.3247|||TWO_SIDED|95.0|3.5094|4.8527||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.8527|3.5094|
74083229|NCT02733627|147719268|OTHER||Slope|1.8868|STANDARD_ERROR_OF_MEAN|0.3069|||TWO_SIDED|95.0|1.2503|2.5234||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|2.5234|1.2503|
74083230|NCT02733627|147719269|OTHER||Slope|3.0677|STANDARD_ERROR_OF_MEAN|0.4844|||TWO_SIDED|95.0|2.0631|4.0723||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.0723|2.0631|
74083231|NCT00183196|147719270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.529|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|0.281|0.997|||Regression, Cox|||||.997|.281|
74083232|NCT00183196|147719270|SUPERIORITY|||||||0.04|||||||Regression, Cox|percent heavy drinking days at baseline was used as a covariate in the analysis as it was a predictor of overall survival independent of group.||||||0.04
74083233|NCT01513239|147719271|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.7|||<|0.0001|TWO_SIDED|95.0|-16.4|-5.1||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||-5.1|-16.4|<0.0001
74083234|NCT01513239|147719271|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.9||||0.0003|TWO_SIDED|95.0|-15.5|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||-4.3|-15.5|0.0003
73959158|NCT04035668|147454272|OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-1.75|1.69|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||1.69|-1.75|
73959159|NCT04035668|147454272|OTHER||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.83|2.21|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||2.21|-1.83|
73959160|NCT04035668|147454272|OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.2|1.01|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||1.01|-3.20|
74083235|NCT01513239|147719271|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.8||||0.3718|TWO_SIDED|95.0|-5.9|4.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||4.2|-5.9|0.3718
74083236|NCT01513239|147719272|SUPERIORITY_OR_OTHER||Adjusted Difference|5.2||||0.0722|TWO_SIDED|95.0|-1.8|12.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||12.2|-1.8|0.0722
74083237|NCT01513239|147719272|SUPERIORITY_OR_OTHER||Adjusted Difference|14.6|||<|0.0001|TWO_SIDED|95.0|7.7|21.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||21.4|7.7|<0.0001
74083238|NCT01513239|147719272|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.4||||0.9969|TWO_SIDED|95.0|-16.1|-2.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||-2.7|-16.1|0.9969
74083239|NCT01513239|147719273|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.9||||0.0006|TWO_SIDED|95.0|-19.0|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||-4.7|-19.0|0.0006
74083240|NCT01513239|147719273|SUPERIORITY_OR_OTHER||Adjusted Difference|-13.7|||<|0.0001|TWO_SIDED|95.0|-20.4|-6.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||-6.9|-20.4|<0.0001
73836872|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.58|1.05||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.05|0.58|
73959161|NCT04035668|147454272|OTHER||Mean Difference (Final Values)|-1.45|||||TWO_SIDED|95.0|-3.5|0.6|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||0.60|-3.50|
73959162|NCT04035668|147454272|OTHER||Mean Difference (Final Values)|-1.14|||||TWO_SIDED|95.0|-3.22|0.95|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||0.95|-3.22|
73959163|NCT04035668|147454273|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.46|TWO_SIDED|95.0|-0.69|0.62||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.62|-0.69|0.460
73959164|NCT04035668|147454273|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.418|TWO_SIDED|95.0|-0.82|0.66||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||0.66|-0.82|0.418
73959165|NCT04035668|147454273|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.466|TWO_SIDED|95.0|-0.76|0.7||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||0.70|-0.76|0.466
73959166|NCT04035668|147454273|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.56|TWO_SIDED|95.0|-0.67|0.79||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||0.79|-0.67|0.560
73959167|NCT04035668|147454273|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.616|TWO_SIDED|95.0|-0.73|0.99||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||0.99|-0.73|0.616
73959168|NCT04035668|147454273|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.581|TWO_SIDED|95.0|-0.81|0.99||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|0.99|-0.81|0.581
73959169|NCT04035668|147454273|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.663|TWO_SIDED|95.0|-0.62|0.96||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||0.96|-0.62|0.663
73959170|NCT04035668|147454273|OTHER||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|95.0|-1.35|0.11|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||0.11|-1.35|
73959171|NCT04035668|147454273|OTHER||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.42|0.26|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||0.26|-1.42|
74083241|NCT01513239|147719273|SUPERIORITY_OR_OTHER||Adjusted Difference|1.6||||0.6962|TWO_SIDED|95.0|-4.6|8.0||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||8.0|-4.6|0.6962
74083242|NCT01513239|147719274|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.9||||0.408|TWO_SIDED|95.0|-9.8|4.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo +SOC|||4.0|-9.8|0.408
74083243|NCT01513239|147719274|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.3||||0.517|TWO_SIDED|95.0|-9.2|4.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||4.6|-9.2|0.517
73836873|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.67|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.21|0.67|
73959172|NCT04035668|147454273|OTHER||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-1.31|0.42|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||0.42|-1.31|
73959173|NCT04035668|147454273|OTHER||Mean Difference (Final Values)|-0.57|||||TWO_SIDED|95.0|-1.44|0.31|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||0.31|-1.44|
73959174|NCT04035668|147454273|OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-1.39|0.65|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||0.65|-1.39|
74083244|NCT01513239|147719275|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.2||||0.931|TWO_SIDED|95.0|-3.8|3.5|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||3.5|-3.8|0.931
74083245|NCT01513239|147719275|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0||||0.997|TWO_SIDED|95.0|-3.7|3.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||3.6|-3.7|0.997
74083246|NCT01513239|147719276|SUPERIORITY_OR_OTHER||Difference in Percentages|0.5||||0.328|TWO_SIDED|95.0|-0.8|2.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||2.0|-0.8|0.328
74083247|NCT01513239|147719276|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.3||||0.308|TWO_SIDED|95.0|-1.5|0.7|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||0.7|-1.5|0.308
74083248|NCT01513239|147719277|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||1.0|-1.0|>0.999
73959175|NCT04035668|147454273|OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-1.39|0.65|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||0.65|-1.39|
73959176|NCT04035668|147454273|OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.37|0.57|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||0.57|-1.37|
73959177|NCT04035668|147454274|SUPERIORITY||Mean Difference (Final Values)|-2.73||||0.94|TWO_SIDED|95.0|-6.18|0.73||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.73|-6.18|0.940
73959178|NCT04035668|147454274|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.322|TWO_SIDED|95.0|-2.95|4.74||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||4.74|-2.95|0.322
73959179|NCT04035668|147454274|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.753|TWO_SIDED|95.0|-5.32|2.59||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||2.59|-5.32|0.753
73959180|NCT04035668|147454274|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.891|TWO_SIDED|95.0|-7.13|1.66||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||1.66|-7.13|0.891
73959181|NCT04035668|147454274|SUPERIORITY||Mean Difference (Final Values)|-3.88||||0.941|TWO_SIDED|95.0|-8.77|1.01||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||1.01|-8.77|0.941
73959182|NCT04035668|147454274|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.304|TWO_SIDED|95.0|-4.01|6.79||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|6.79|-4.01|0.304
74083249|NCT01513239|147719277|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||1.0|-1.0|>0.999
74083250|NCT01513239|147719278|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.4|||||TWO_SIDED|95.0|-4.2|3.3|||||MK-3415A + SOC minus Placebo + SOC|||3.3|-4.2|
74083251|NCT01513239|147719278|SUPERIORITY_OR_OTHER||Difference in Percentages|1.2|||||TWO_SIDED|95.0|-2.7|5.2|||||MK-6072 + SOC minus Placebo + SOC|||5.2|-2.7|
74083252|NCT00059332|147719301|SUPERIORITY_OR_OTHER|||||||0.28|ONE_SIDED||||||Cochran-Mantel-Haenszel|||For the primary efficacy analysis, data were analyzed to test the null hypothesis that the distribution of scores over all 7 levels of the modified Rankin Scale at Day 90 was identical in the magnesium sulfate and placebo groups, vs. the one-sided alternative that the distribution of scores is shifted lower in the active magnesium sulfate therapy group. The statistic used to test the primary hypothesis was the Cochran-Mantel-Haenszel test statistic stratified by transport vehicle.||||0.28
74083253|NCT00059332|147719302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.87|TWO_SIDED|95.0|0.81|1.2|||Chi-squared|||||1.20|0.81|0.87
74083254|NCT00059332|147719303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.87|TWO_SIDED|95.0|0.81|1.19|||Chi-squared|||||1.19|0.81|0.87
74083255|NCT00059332|147719304|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2760
73959183|NCT04035668|147454274|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.64|TWO_SIDED|95.0|-6.89|4.79||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||4.79|-6.89|0.640
73959184|NCT04035668|147454274|OTHER||Mean Difference (Final Values)|2.32|||||TWO_SIDED|95.0|-1.44|6.07|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||6.07|-1.44|
73959185|NCT04035668|147454274|OTHER||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-3.46|5.18|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||5.18|-3.46|
73959186|NCT04035668|147454274|OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-4.43|4.83|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||4.83|-4.43|
73959187|NCT04035668|147454274|OTHER||Mean Difference (Final Values)|0.63|||||TWO_SIDED|95.0|-4.53|5.78|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||5.78|-4.53|
73959188|NCT04035668|147454274|OTHER||Mean Difference (Final Values)|1.11|||||TWO_SIDED|95.0|-4.6|6.82|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||6.82|-4.60|
73959189|NCT04035668|147454274|OTHER||Mean Difference (Final Values)|5.69|||||TWO_SIDED|95.0|-0.66|12.04|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||12.04|-0.66|
73959190|NCT04035668|147454274|OTHER||Mean Difference (Final Values)|3.53|||||TWO_SIDED|95.0|-3.53|10.59|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||10.59|-3.53|
73959191|NCT04035668|147454275|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.494|TWO_SIDED|95.0|-7.84|7.96||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||7.96|-7.84|0.494
73959192|NCT04035668|147454275|SUPERIORITY||Mean Difference (Final Values)|-3.87||||0.866|TWO_SIDED|95.0|-10.81|3.06||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||3.06|-10.81|0.866
73959193|NCT04035668|147454275|SUPERIORITY||Mean Difference (Final Values)|-1.82||||0.684|TWO_SIDED|95.0|-9.37|5.73||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||5.73|-9.37|0.684
73959194|NCT04035668|147454275|SUPERIORITY||Mean Difference (Final Values)|-4.39||||0.908|TWO_SIDED|95.0|-10.93|2.14||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||2.14|-10.93|0.908
73959195|NCT04035668|147454275|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.487|TWO_SIDED|95.0|-8.0|8.26||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||8.26|-8.00|0.487
73959196|NCT04035668|147454275|SUPERIORITY||Mean Difference (Final Values)|-3.06||||0.79|TWO_SIDED|95.0|-10.61|4.49||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|4.49|-10.61|0.790
73959197|NCT04035668|147454275|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.34|TWO_SIDED|95.0|-6.48|9.88||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||9.88|-6.48|0.340
73959198|NCT04035668|147454275|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-9.06|8.68|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||8.68|-9.06|
73959199|NCT04035668|147454275|OTHER||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-9.59|6.17|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||6.17|-9.59|
73959200|NCT04035668|147454275|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-9.34|8.74|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||8.74|-9.34|
73959201|NCT04035668|147454275|OTHER||Mean Difference (Final Values)|-3.94|||||TWO_SIDED|95.0|-11.74|3.86|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||3.86|-11.74|
74083256|NCT00059332|147719305|SUPERIORITY_OR_OTHER|||||||0.3912|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3912
74083257|NCT00059332|147719306|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3230
73959202|NCT04035668|147454275|OTHER||Mean Difference (Final Values)|-4.71|||||TWO_SIDED|95.0|-14.34|4.93|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||4.93|-14.34|
73959203|NCT04035668|147454275|OTHER||Mean Difference (Final Values)|-6.29|||||TWO_SIDED|95.0|-15.44|2.87|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||2.87|-15.44|
73959204|NCT04035668|147454275|OTHER||Mean Difference (Final Values)|-3.92|||||TWO_SIDED|95.0|-14.01|6.16|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||6.16|-14.01|
73959205|NCT04035668|147454276|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.575|TWO_SIDED|95.0|-6.75|8.16||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||8.16|-6.75|0.575
73959206|NCT04035668|147454276|SUPERIORITY||Mean Difference (Final Values)|-1.98||||0.294|TWO_SIDED|95.0|-9.22|5.27||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||5.27|-9.22|0.294
73959207|NCT04035668|147454276|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.45|TWO_SIDED|95.0|-8.4|7.41||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||7.41|-8.40|0.450
73959208|NCT04035668|147454276|SUPERIORITY||Mean Difference (Final Values)|6.02||||0.913|TWO_SIDED|95.0|-2.74|14.78||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||14.78|-2.74|0.913
73959209|NCT04035668|147454276|SUPERIORITY||Mean Difference (Final Values)|2.59||||0.722|TWO_SIDED|95.0|-6.16|11.34||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||11.34|-6.16|0.722
74083258|NCT00059332|147719307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.95|TWO_SIDED|95.0|0.87|1.27|||Chi-squared|||||1.27|0.87|0.95
74083259|NCT00059332|147719308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.12|TWO_SIDED|95.0|0.34|1.14|||Chi-squared|||||1.14|0.34|0.12
74083260|NCT00059332|147719309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.76|1.29|||Chi-squared|||||1.29|0.76|0.95
73959210|NCT04035668|147454276|SUPERIORITY||Mean Difference (Final Values)|-2.86||||0.241|TWO_SIDED|95.0|-10.96|5.24||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|5.24|-10.96|0.241
73959211|NCT04035668|147454276|SUPERIORITY||Mean Difference (Final Values)|2.95||||0.742|TWO_SIDED|95.0|-6.09|11.99||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||11.99|-6.09|0.742
73959212|NCT04035668|147454276|OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-8.28|7.91|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||7.91|-8.28|
73959213|NCT04035668|147454276|OTHER||Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-8.87|7.58|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||7.58|-8.87|
73959214|NCT04035668|147454276|OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-9.28|9.48|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||9.48|-9.28|
73959215|NCT04035668|147454276|OTHER||Mean Difference (Final Values)|-4.4|||||TWO_SIDED|95.0|-14.71|5.9|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||5.90|-14.71|
73959216|NCT04035668|147454276|OTHER||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-22.47|-1.77|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||-1.77|-22.47|
73959217|NCT04035668|147454276|OTHER||Mean Difference (Final Values)|-6.25|||||TWO_SIDED|95.0|-16.0|3.5|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||3.50|-16.00|
73959218|NCT04035668|147454276|OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-19.16|2.96|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||2.96|-19.16|
73959219|NCT00831272|147454301|SUPERIORITY_OR_OTHER|||||||0.32|||||||Generalized Estimating Equation|||||||0.32
73959220|NCT00516386|147454302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|543.0|STANDARD_ERROR_OF_MEAN|41.0|<|0.05|||||||Paired t-test|||We used paired t-tests to assess changes in levels of IGF-1 from baseline levels in girls with AN receiving rhIGF-1. Our hypothesis was that rhIGF-1 administration would be associated with a significant increase in IGF-1 levels.||||<0.05
73959221|NCT00516386|147454303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|39.3|STANDARD_ERROR_OF_MEAN|9.3|<|0.05||95.0|||||Paired t-test|||We used a paired t-test to determine the change in P1NP from baseline to 7-10 days following administration of rhIGF-1||||<0.05
73959222|NCT02680457|147454313|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.630
73959223|NCT02680457|147454314|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
73959224|NCT01192542|147454315|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0064|||TWO_SIDED|95.0|-0.022|0.003|||Mixed Models Analysis|Comparisons between two lenses were carried out using 95% confidence intervals (CI) constructed for least-square mean differences.|The mean difference is calculated as: Test lens - Control lens.|The alternative hypothesis is the monocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.||0.003|-0.022|
74083261|NCT01721772|147719390|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.6|||Stratified Log Rank Test|||||0.60|0.30|<0.0001
73959225|NCT01192542|147454318|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.0091|||TWO_SIDED|95.0|-0.018|0.018|||Mixed Models Analysis|Comparisons between two lenses were carried out using 95% confidence intervals (CI) constructed for least-square mean differences.||The alternative hypothesis is the binocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.||0.018|-0.018|
73959226|NCT01901276|147454341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||t-test, 2 sided|||Within-individual differences in Shannon indices were tested using paired t tests (normally distributed data).||||0.71
73959227|NCT01596504|147454342|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-6.01|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|ONE_SIDED|95.0|-7.77|||p-values ordered(p1≤p2) as per rules:if p2≤0.05: lixisenatide superior to liraglutide (both doses);if p2\>0.05 \& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\>0.05 \& p1\>0.025:no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1.2 mg|Analysis was performed using linear fixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \[\<8% and \>=8%\], use of metformin at screening \[yes or no\]) and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|||-7.77|<0.0001
73959228|NCT01596504|147454342|SUPERIORITY_OR_OTHER||LS mean difference|-4.61|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|ONE_SIDED|95.0|-6.34|||p-values ordered(p1≤p2) as per rules:if p2≤0.05:lixisenatide superior to liraglutide (both doses);if p2\>0.05 \& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\>0.05 \& p1\>0.025: no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1. 8 mg|Analysis was performed using linear mixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \[\<8% and \>=8%\], use of metformin at screening \[yes or no\]), and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|||-6.34|<0.0001
73959229|NCT02026258|147454359|OTHER||Mean Difference (Final Values)|0.52|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Based on previous findings, it takes approximately 117 ± 46 days for complete alignment of the mandibular anterior teeth in subjects with severe crowding treated without extractions. For a clinically significant 40% faster alignment in the piezotome-corticision group compared to the control group at an alpha-level (p = 0.05) and desired power of 80%, a sample size of 28 subjects (14 per group) was required. Twenty subjects per group assuming an overall attrition rate of 28%.||||<0.05
73959230|NCT02026258|147454360|OTHER||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T0||||<0.05
73959231|NCT02026258|147454360|OTHER||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T1||||<0.05
73959232|NCT02026258|147454360|OTHER||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T2||||<0.05
73959233|NCT02026258|147454360|OTHER||Mean Difference (Final Values)|0.76|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T3||||<0.05
73959234|NCT02026258|147454361|OTHER||Mean Difference (Final Values)|0.87|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ease of Procedure||||<0.05
73959235|NCT02026258|147454361|OTHER||Mean Difference (Final Values)|0.69|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Satisfaction with procedure||||<0.05
73959236|NCT02026258|147454362|OTHER||Fisher chi square|0.71|||<|0.05|TWO_SIDED||||||Fisher Exact|Use of Medications||||||<0.05
74083262|NCT01721772|147719391|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.34|0.56|||Stratified Log Rank Test|||||0.56|0.34|<0.0001
73959237|NCT02026258|147454362|OTHER||Fisher chi square|0.99|||<|0.05|TWO_SIDED||||||Fisher Exact|||Undergo procedure again||||<0.05
73959238|NCT02026258|147454362|OTHER||Fisher chi square|0.49|||<|0.05|TWO_SIDED||||||Fisher Exact|||Recommend procedure to a friend||||<0.05
74083263|NCT01721772|147719393|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.43|||<|0.0001|TWO_SIDED|95.0|2.75|7.13|||Cochran-Mantel-Haenszel|||||7.13|2.75|<0.0001
73959239|NCT00530842|147454363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.044||0.0482|TWO_SIDED|95.0|-0.174|-0.001|||ANOVA|ANOVA with fixed terms for sequence, treatment, and period and random term for subject within sequence.||||-0.001|-0.174|0.0482
73959240|NCT00530842|147454364|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.0||||0.3407|TWO_SIDED|95.0|-9.5|27.5|||Wilcoxon signed-rank test||The confidence interval was determined by Hodges-Lehmann method.|||27.5|-9.5|0.3407
73959241|NCT04347954|147454450|OTHER||Mean Difference (Net)|-0.349|||||TWO_SIDED|95.0|-1.584|0.886||||||Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.||0.886|-1.584|
73959242|NCT04347954|147454450|OTHER||Mean Difference (Net)|-1.059|||||TWO_SIDED|95.0|-2.318|0.201||||||Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.||0.201|-2.318|
73959243|NCT02534350|147454461|SUPERIORITY||Treatment Difference|0.1||||0.72|TWO_SIDED|95.0|-0.43|0.63|||ANCOVA|||||0.63|-0.43|0.72
73959244|NCT02534350|147454462|SUPERIORITY||Treatment Difference|-0.12||||0.76|TWO_SIDED|95.0|-0.94|0.69|||ANCOVA|||||0.69|-0.94|0.76
73959245|NCT02534350|147454463|SUPERIORITY||Treatment Difference|0.01||||0.86|TWO_SIDED|95.0|-0.12|0.15|||ANCOVA|||||0.15|-0.12|0.86
73959246|NCT02534350|147454464|SUPERIORITY||Treatment Difference|-3.25||||0.6|TWO_SIDED|95.0|-15.58|9.08|||ANCOVA|||||9.08|-15.58|0.60
74083264|NCT01721772|147719394|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.37|||||TWO_SIDED|95.0|0.24|0.56|||||PD-L1 positive group|||0.56|0.24|
74083265|NCT01721772|147719394|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.6|||||TWO_SIDED|95.0|0.45|0.8|||||PD-L1 negative group|||0.80|0.45|
74083266|NCT01721772|147719397|SUPERIORITY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.41|0.65||||||||0.65|0.41|
74083267|NCT02542462|147719405|SUPERIORITY|||||||0.2||||||P value for the number of subjects with an increase of 1 mm or more of terminal ileum from pre to post was 0.2|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes||||0.2
74083268|NCT02542462|147719405|SUPERIORITY|||||||0.3||||||P value for change in the number of subjects with an increase in number of lymph nodes from pre to post was 0.3.|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes||||0.3
74083269|NCT02637141|147719421|SUPERIORITY|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|-2.49|STANDARD_ERROR_OF_MEAN|7.1||0.7271|TWO_SIDED|95.0|-16.82|11.83|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||11.83|-16.82|0.7271
73836874|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.7|1.25||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.25|0.70|
73959247|NCT00761930|147454509|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
73959248|NCT00761930|147454510|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
73959249|NCT00761930|147454511|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
74083270|NCT02637141|147719421|SUPERIORITY|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|6.39|STANDARD_ERROR_OF_MEAN|6.67||0.3438|TWO_SIDED|95.0|-7.07|19.85|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||19.85|-7.07|0.3438
74083271|NCT02637141|147719422|SUPERIORITY||LS Mean Difference|-14.32|STANDARD_ERROR_OF_MEAN|19.85||0.4746|TWO_SIDED|95.0|-54.39|25.74|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||25.74|-54.39|0.4746
74083272|NCT02637141|147719422|SUPERIORITY||LS Mean Difference|-41.24|STANDARD_ERROR_OF_MEAN|18.85||0.0343|TWO_SIDED|95.0|-79.28|-3.2|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||-3.2|-79.28|0.0343
73959250|NCT03257813|147454512|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.013||||||Baseline|t-test, 2 sided|||||||0.013
73959251|NCT03257813|147454512|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.001||||||CrossOver|t-test, 2 sided|||||||0.001
73959252|NCT03257813|147454512|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.05||||||Final Visit|t-test, 2 sided|||||||0.050
73959253|NCT03257813|147454513|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.823||||||Baseline|t-test, 2 sided|||||||0.823
73959254|NCT03257813|147454513|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.507||||||CrossOver|t-test, 2 sided|||||||0.507
73959255|NCT03257813|147454513|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.495||||||Final Visit|t-test, 2 sided|||||||0.495
73959256|NCT03257813|147454514|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.085|||||||Chi-squared|||||||0.085
73959257|NCT03257813|147454515|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.001||||||Baseline|Fisher Exact|||||||0.001
73959258|NCT03257813|147454515|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.148||||||CrossOver|Fisher Exact|||||||0.148
73959259|NCT03257813|147454515|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.212||||||Final Visit|Fisher Exact|||||||0.212
73959260|NCT03257813|147454516|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||Baseline|Chi-squared, Corrected|||||||0.497
73959261|NCT03257813|147454516|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||CrossOver|Chi-squared, Corrected|||||||0.497
74083273|NCT02637141|147719424|SUPERIORITY||LS Mean Difference|4402.25|STANDARD_ERROR_OF_MEAN|1717.4||0.014|TWO_SIDED|95.0|936.39|7868.1|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||7868.10|936.39|0.0140
74083274|NCT02637141|147719424|SUPERIORITY||LS Mean Difference|944.9|STANDARD_ERROR_OF_MEAN|1167.22||0.4228|TWO_SIDED|95.0|-1410.65|3300.44|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||3300.44|-1410.65|0.4228
74083275|NCT02637141|147719425|SUPERIORITY||LS Mean Difference|17.8|STANDARD_ERROR_OF_MEAN|17.09||0.3034|TWO_SIDED|95.0|-16.68|52.29|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA||52.29|-16.68|0.3034
74083276|NCT02637141|147719425|SUPERIORITY||LS Mean Difference|-6.92|STANDARD_ERROR_OF_MEAN|15.46||0.6569|TWO_SIDED|95.0|-38.11|24.28|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA||24.28|-38.11|0.6569
74083277|NCT02637141|147719425|SUPERIORITY||LS Mean Difference|13.17|STANDARD_ERROR_OF_MEAN|26.77||0.6254|TWO_SIDED|95.0|-40.86|67.2|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgG||67.20|-40.86|0.6254
74083278|NCT02637141|147719425|SUPERIORITY||LS Mean Difference|2.86|STANDARD_ERROR_OF_MEAN|21.66||0.8955|TWO_SIDED|95.0|-40.84|46.57|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP IgG||46.57|-40.84|0.8955
74083279|NCT02637141|147719426|SUPERIORITY||Ratio of LS Means|0.83|STANDARD_ERROR_OF_MEAN|0.11||0.161|TWO_SIDED|95.0|0.63|1.08|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.||Analysis of Total Weekly Bowel Movements at Week 12||1.08|0.63|0.1610
73836875|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.73|1.46||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.46|0.73|
74083280|NCT02637141|147719426|SUPERIORITY||Ratio of LS Means|1.03|STANDARD_ERROR_OF_MEAN|0.13||0.781|TWO_SIDED|95.0|0.81|1.32|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.||||1.32|0.81|0.7810
74083281|NCT02637141|147719428|SUPERIORITY||LS Mean Difference|-13.44|STANDARD_ERROR_OF_MEAN|12.33||0.2761|TWO_SIDED|95.0|-37.66|10.77|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||10.77|-37.66|0.2761
74083282|NCT02637141|147719428|SUPERIORITY||LS Mean Difference|-2.62|STANDARD_ERROR_OF_MEAN|11.66||0.8221|TWO_SIDED|95.0|-25.51|20.27|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||20.27|-25.51|0.8221
74083283|NCT02637141|147719429|SUPERIORITY||LS Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|2.1||0.1908|TWO_SIDED|95.0|-6.89|1.3|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||1.3|-6.89|0.1908
74083284|NCT02637141|147719429|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|1.98||0.4088|TWO_SIDED|95.0|-5.53|2.25|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||2.25|-5.53|0.4088
74083285|NCT01559116|147719463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.252|0.309|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.309|0.252|<0.0001
73836876|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.83|1.43||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.43|0.83|
73836877|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.7|1.2||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.70|
73836878|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.61|1.15||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.15|0.61|
73836879|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.51|1.15||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.51|
73836880|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.46|1.03||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.03|0.46|
73836881|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.56|1.44||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.44|0.56|
73959262|NCT03257813|147454516|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0||||||"Final Visit~No statistic will be calculated because Final Chemosis is a constant"|Chi-squared, Corrected|||||||0
74083286|NCT01559116|147719463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.087|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.143|0.087|<0.0001
74083287|NCT01559116|147719463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.082|0.139|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.139|0.082|<0.0001
74083288|NCT01559116|147719463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.277|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.249|0.306|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.|||0.306|0.249|<0.0001
74083289|NCT01559116|147719463|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.083|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.140|0.083|<0.0001
74083290|NCT01559116|147719463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.096|0.152|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.152|0.096|<0.0001
74083291|NCT01559116|147719463|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.079|0.136|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.136|0.079|<0.0001
74083292|NCT01559116|147719464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.319|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.289|0.349|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.349|0.289|<0.0001
74083293|NCT01559116|147719464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.096|0.156|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.156|0.096|<0.0001
74083294|NCT01559116|147719464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.089|0.149|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.149|0.089|<0.0001
74083295|NCT01559116|147719464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.293|0.354|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.354|0.293|<0.0001
73836882|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.74|1.37||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.37|0.74|
73836883|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.67|1.23||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.67|
73836884|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.63|1.29||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.29|0.63|
74083296|NCT01559116|147719464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.101|0.161|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.161|0.101|<0.0001
74083297|NCT01559116|147719464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.109|0.169|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.169|0.109|<0.0001
74083298|NCT01559116|147719464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.093|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.154|0.093|<0.0001
74083299|NCT01559116|147719465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.212|0.273|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.273|0.212|<0.0001
74083300|NCT01559116|147719465|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.074|0.133|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.133|0.074|<0.0001
74083301|NCT01559116|147719465|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.072|0.132|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.132|0.072|<0.0001
74083302|NCT01559116|147719465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.201|0.262|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.262|0.201|<0.0001
74083303|NCT01559116|147719465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.063|0.123|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.123|0.063|<0.0001
74083304|NCT01559116|147719465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.08|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.140|0.080|<0.0001
74083305|NCT01559116|147719465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.061|0.121|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.121|0.061|<0.0001
74083306|NCT01559116|147719466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.173|0.241|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.241|0.173|<0.0001
74083307|NCT01559116|147719466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.059|0.126|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.126|0.059|<0.0001
74083308|NCT01559116|147719466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.045|0.113|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.113|0.045|<0.0001
74083309|NCT01559116|147719466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.167|0.235|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.235|0.167|<0.0001
74083310|NCT01559116|147719466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.052|0.12|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.120|0.052|<0.0001
74083311|NCT01559116|147719466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.067|0.135|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.135|0.067|<0.0001
74083312|NCT01559116|147719466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.039|0.107|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.107|0.039|<0.0001
74083313|NCT01559116|147719467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.338|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.305|0.371|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.371|0.305|<0.0001
74083314|NCT01559116|147719467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.087|0.153|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.153|0.087|<0.0001
74083315|NCT01559116|147719467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.078|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.143|0.078|<0.0001
74083316|NCT01559116|147719467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.317|0.383|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.383|0.317|<0.0001
74083317|NCT01559116|147719467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.098|0.164|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.164|0.098|<0.0001
74083318|NCT01559116|147719467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.099|0.165|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.165|0.099|<0.0001
74083319|NCT01559116|147719467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.089|0.155|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.155|0.089|<0.0001
74083320|NCT01559116|147719468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.433|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.389|0.477|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.477|0.389|<0.0001
74083321|NCT01559116|147719468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.166|0.253|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.253|0.166|<0.0001
74083322|NCT01559116|147719468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.133|0.221|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.221|0.133|<0.0001
74083323|NCT01559116|147719468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.396|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.352|0.441|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.441|0.352|<0.0001
74083324|NCT01559116|147719468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.129|0.217|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.217|0.129|<0.0001
74083325|NCT01559116|147719468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.115|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated. is calculated.|||0.203|0.115|<0.0001
73836885|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|3.1|||||TWO_SIDED|95.0|2.4|4.06||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.06|2.40|
74083326|NCT01559116|147719468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.096|0.184|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.184|0.096|<0.0001
74083327|NCT01559116|147719469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.463|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.417|0.509|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.|||0.509|0.417|<0.0001
74083328|NCT01559116|147719469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.154|0.246|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.246|0.154|<0.0001
74083329|NCT01559116|147719469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.133|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.225|0.133|<0.0001
74083330|NCT01559116|147719469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.443|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.396|0.49|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.490|0.396|<0.0001
74083331|NCT01559116|147719469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.134|0.227|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.227|0.134|<0.0001
74083332|NCT01559116|147719469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.125|0.218|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.218|0.125|<0.0001
74083333|NCT01559116|147719469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.113|0.206|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.206|0.113|<0.0001
74083334|NCT01559116|147719470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.404|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.355|0.453|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.453|0.355|<0.0001
74083335|NCT01559116|147719470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.17|0.267|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.267|0.170|<0.0001
74083336|NCT01559116|147719470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.126|0.223|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.223|0.126|<0.0001
74083337|NCT01559116|147719470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.351|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.301|0.4|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.400|0.301|<0.0001
74083338|NCT01559116|147719470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.117|0.214|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.214|0.117|<0.0001
74083339|NCT01559116|147719470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.099|0.197|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.197|0.099|<0.0001
74083340|NCT01559116|147719470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.170|0.072|<0.0001
74083341|NCT01559116|147719471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.274|0.385|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.385|0.274|<0.0001
74083342|NCT01559116|147719471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.115|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.225|0.115|<0.0001
74083343|NCT01559116|147719471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.066|0.176|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.176|0.066|<0.0001
74083344|NCT01559116|147719471|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.251|0.363|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.363|0.251|<0.0001
74083345|NCT01559116|147719471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.092|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.203|0.092|<0.0001
74083346|NCT01559116|147719471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.111|0.222|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.222|0.111|<0.0001
74083347|NCT01559116|147719471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.043|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.154|0.043|<0.0001
74083348|NCT01559116|147719472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.408|0.516|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.516|0.408|<0.0001
74083349|NCT01559116|147719472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.105|0.212|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.212|0.105|<0.0001
74083350|NCT01559116|147719472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.098|0.205|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.205|0.098|<0.0001
74083351|NCT01559116|147719472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.452|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.398|0.507|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.507|0.398|<0.0001
74083352|NCT01559116|147719472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.095|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.203|0.095|<0.0001
74083353|NCT01559116|147719472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.107|0.216|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.216|0.107|<0.0001
74083354|NCT01559116|147719472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.087|0.196|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.196|0.087|<0.0001
74083355|NCT00021541|147719481|SUPERIORITY|||||||0.012|||||||Repeated measures ANOVA|||||||0.012
74083356|NCT00021541|147719481|OTHER|||||||0.015|||||||Repeated measures ANOVA|||Post hoc test: tipifarnib group F=7.40||||0.015
74083357|NCT00021541|147719481|OTHER|||||||0.66|||||||Repeated measures ANOVA|||Post hoc test: placebo group F=0.19||||0.66
74083358|NCT03201003|147719502|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.0001|TWO_SIDED|95.0|44.1|65.2|||Fisher Exact|||Treatment difference at 1000 mg||65.2|44.1|<0.0001
74083359|NCT03201003|147719503|SUPERIORITY||Risk Difference (RD)|58.9|||<|0.0001|TWO_SIDED|95.0|44.2|69.3|||Fisher Exact|||Treatment difference at 600 mg||69.3|44.2|<0.0001
74083360|NCT03201003|147719504|SUPERIORITY||Risk Difference (RD)|57.2|||<|0.0001|TWO_SIDED|95.0|41.2|69.1|||Fisher Exact|||Treatment difference at 300 mg||69.1|41.2|<0.0001
74083361|NCT03201003|147719505|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic (with equally spaced scores) stratified by country||Treatment difference in Maximum Severity||||<0.0001
74083362|NCT00834613|147719506|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.45||||||90.0|99.87|107.15|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.15|99.87|
74083363|NCT00834613|147719507|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.21|100.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.11|95.21|
74083364|NCT00834613|147719508|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.22|100.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.1|95.22|
74083365|NCT00697619|147719518|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.370
74083366|NCT00697619|147719518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
74083367|NCT00697619|147719518|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
74083368|NCT02005562|147719525|SUPERIORITY_OR_OTHER|||||||0.479|||||||Chi-squared|||||||0.479
74083369|NCT02005562|147719526|SUPERIORITY_OR_OTHER|||||||0.6736|||||||ANOVA|||||||0.6736
74083370|NCT02005562|147719527|SUPERIORITY_OR_OTHER|||||||0.2172|||||||ANOVA|||||||0.2172
74083371|NCT02005562|147719528|SUPERIORITY_OR_OTHER|||||||0.477|||||||ANOVA|||||||0.4770
74083372|NCT02005562|147719530|SUPERIORITY_OR_OTHER|||||||0.0764|||||||Log Rank|||||||0.0764
74083373|NCT02005562|147719531|SUPERIORITY_OR_OTHER|||||||0.418|||||||Fisher Exact|||Week 12||||0.418
74083374|NCT02005562|147719531|SUPERIORITY_OR_OTHER|||||||0.841|||||||Fisher Exact|||Week 52||||0.841
74083375|NCT02005562|147719532|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||Week 12||||0.245
74083376|NCT02005562|147719532|SUPERIORITY_OR_OTHER|||||||0.637|||||||Fisher Exact|||Week 52||||0.637
74083377|NCT02005562|147719533|SUPERIORITY_OR_OTHER|||||||0.512||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 12.|Fisher Exact|||||||0.512
74083378|NCT02005562|147719533|SUPERIORITY_OR_OTHER|||||||0.718||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 52.|Fisher Exact|||||||0.718
74083379|NCT02005562|147719535|SUPERIORITY_OR_OTHER|||||||0.86|||||||Log Rank|||||||0.860
74083380|NCT00288704|147719541|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
74083381|NCT00288704|147719542|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||"Subjects received rilonacept 160 mg for 9 weeks (weeks 6-15), and then were re-randomized 1:1 into either Placebo or rilonacept 160 mg. The endpoint for the period was 9 weeks later (week 24).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.001
74083382|NCT00288704|147719543|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
74083383|NCT00288704|147719544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison P-Value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
74083384|NCT00288704|147719545|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison p-value is a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
74083385|NCT00288704|147719546|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.0001
74083386|NCT00288704|147719547|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.01
74083387|NCT00288704|147719548|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
74083388|NCT00288704|147719549|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
74083389|NCT00288704|147719550|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
74083390|NCT01579006|147719571|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
74083391|NCT01579006|147719572|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
74083392|NCT01579006|147719573|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
74083393|NCT01579006|147719575|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
74083394|NCT01579006|147719576|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
74083395|NCT01579006|147719582|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
74083396|NCT01579006|147719583|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
74083397|NCT01579006|147719584|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
74083398|NCT01579006|147719585|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
73836886|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.39|0.66||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.66|0.39|
74083399|NCT01579006|147719586|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
74083400|NCT01579006|147719588|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
74083401|NCT00799708|147719592|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||ANOVA|||||||0.345
74083402|NCT00799708|147719592|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||ANOVA|||||||0.166
74083403|NCT00799708|147719593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.12|TWO_SIDED|90.0|-0.16|0.92|||ANCOVA|||||0.92|-0.16|0.120
74083404|NCT02153723|147719604|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|21.6||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
74083405|NCT02153723|147719605|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|-2.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
74083406|NCT02153723|147719606|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|-0.1||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.004
74083407|NCT02153723|147719607|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|15.9||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.08
74083408|NCT02153723|147719608|OTHER|Wilcoxon signed rank sum test|Mean Difference (Final Values)|0.8||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
74083409|NCT02153723|147719609|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|0.0||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.44
74083410|NCT02697617|147719610|SUPERIORITY|||||||0.024||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.024
74083411|NCT02697617|147719611|SUPERIORITY|||||||0.14||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.14
74083412|NCT02697617|147719613|OTHER||||||||||||||||||comparison by paired t-test|||
74083413|NCT02697617|147719614|SUPERIORITY|||||||0.15||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.15
74083414|NCT02697617|147719615|SUPERIORITY|||||||0.4||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|paired t test|||||||0.4
74083415|NCT01157234|147719632|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|28.73|||||TWO_SIDED|95.0|1.93|55.53||||||||55.53|1.93|
74083416|NCT01157234|147719633|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.27|||||TWO_SIDED|95.0|-12.58|29.12||||||||29.12|-12.58|
74083417|NCT01157234|147719634|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.23|STANDARD_ERROR_OF_MEAN|3.87|||TWO_SIDED|95.0|-6.74|9.2||||||||9.20|-6.74|
74083418|NCT01157234|147719638|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|11.94|||||TWO_SIDED|95.0|0.48|23.4||||||||23.40|0.48|
74083419|NCT01157234|147719639|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|69.54|STANDARD_ERROR_OF_MEAN|19.83|||TWO_SIDED|99.7|12.71|126.37||||||||126.37|12.71|
74083420|NCT01157234|147719640|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|68.19|STANDARD_ERROR_OF_MEAN|19.24|||TWO_SIDED|99.17|13.02|123.36||||||||123.36|13.02|
74083421|NCT01157234|147719641|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.39|STANDARD_ERROR_OF_MEAN|17.32|||TWO_SIDED|99.17|-48.25|51.03||||||||51.03|-48.25|
74083422|NCT01157234|147719642|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|17.96|||TWO_SIDED|99.17|-48.74|54.22||||||||54.22|-48.74|
74088220|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.18|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.18|<.0001
73836887|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.12|0.22||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.22|0.12|
74083423|NCT00876265|147719659|NON_INFERIORITY_OR_EQUIVALENCE|If the 95% CI or the difference between LS mean (Belotero) and LS mean (Zyplast) lies entirely above -Δ, noninferiority of Belotero will be concluded (first step). If, in addition, the CI lies entirely above 0, superiority of Belotero over Zyplast will be concluded (second step).|Adjusted (LS) mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.139||0.733|TWO_SIDED|95.0|-0.228|0.323||Treatment term and all significant (p ≤ 0.10) covariate and covariate by treatment interactions will be retained in the final ANCOVA model. From the final ANCOVA model, adjusted (LS) means for Belotero and Zyplast was computed.|ANCOVA|||"The null, H0, and the alternative hypothesis, H1, are as follows:~H0(1): adjusted mean(dadj\[i\]) ≤ -Δ versus H1(1): adjusted mean(dadj\[i\]) \> -Δ H0(2): adjusted mean(dadj\[i\]) ≤ 0 versus H1(2): adjusted mean(dadj\[i\]) \> 0 The sample size calculation was based on the following assumptions: Type I error α = 0.025 (one sided); Power = 90%; Non-inferiority margin Δ = 0.25; Estimated common standard deviation (SD) = 0.75. Under these assumptions, a total of 100 evaluable subjects were needed."||0.323|-0.228|0.733
74083424|NCT01328782|147719703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.074||95.0|1.4|2.94|||ANOVA|||||2.94|1.40|0.074
74083425|NCT01328782|147719703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.556||||0.556||95.0|-1.12|2.08|||ANOVA|||||2.08|-1.12|0.556
74083426|NCT01328782|147719703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.244||95.0|-0.64|2.49|||ANOVA|||||2.49|-0.64|0.244
74083427|NCT01328782|147719704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.014|TWO_SIDED|95.0|0.38|3.25|||ANOVA|||||3.25|0.38|0.014
73836888|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|1.4|||||TWO_SIDED|95.0|1.11|1.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.78|1.11|
73836889|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.66|1.06||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.06|0.66|
74083428|NCT01328782|147719704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.832||95.0|-1.3|1.61|||ANOVA|||||1.61|-1.30|0.832
74083429|NCT01328782|147719704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66||||0.027||95.0|0.2|3.12|||ANOVA|||||3.12|0.20|0.027
74083430|NCT01328782|147719705|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Log Rank|||||||0.005
74083431|NCT01328782|147719705|SUPERIORITY_OR_OTHER|||||||0.3767||95.0|||||Log Rank|||||||0.3767
74083432|NCT01328782|147719705|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Log Rank|||||||0.039
74083433|NCT01328782|147719706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.008||95.0|0.008|0.076|||ANOVA|||||0.076|0.008|0.008
74083434|NCT01328782|147719706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.078||95.0|-0.004|0.066|||ANOVA|||||0.066|-0.004|0.078
74083435|NCT01328782|147719706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.5321||95.0|-0.024|0.045|||ANOVA|||||0.045|-0.024|0.5321
74083436|NCT01328782|147719707|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
74083437|NCT01328782|147719707|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
74083438|NCT01328782|147719707|SUPERIORITY_OR_OTHER|||||||0.499||95.0|||||Chi-squared|||||||0.499
74083439|NCT04535986|147719708|SUPERIORITY||LS mean difference|0.0868|STANDARD_ERROR_OF_MEAN|0.0162|<|0.0001|TWO_SIDED|95.0|0.0551|0.1185||The analysis of covariance (ANCOVA) model was used to model the change from baseline FEV1 to average FEV1 AUC0-12h with treatment, region, background medication strata and smoking strata as fixed effects and baseline FEV1 as covariate.|ANCOVA|||||0.1185|0.0551|<0.0001
74083440|NCT01632215|147719719|SUPERIORITY||Mean Difference (Net)|0.3|||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
74083441|NCT04561115|147719720|EQUIVALENCE|The relative alpha level for statistical significance was 0.1 (alpha=0.05 for one-sided test), or a 90% CI was used for the bioequivalence test.|Geometric Least Square Mean Ratio|0.948|||||TWO_SIDED|90.0|0.926|0.972||||||||0.972|0.926|
74083442|NCT04561115|147719721|EQUIVALENCE|The relative alpha level for statistical significance was 0.1 (alpha=0.05 for one-sided test), or a 90% CI was used for the bioequivalence test.|Geometric Least Square Mean Ratio|0.978|||||TWO_SIDED|90.0|0.937|1.021||||||||1.021|0.937|
74083443|NCT01567527|147719769|SUPERIORITY||Hazard Ratio (HR)|0.451|||<|0.0001|TWO_SIDED|95.0|0.299|0.678|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."|Significance level 0.05.||0.678|0.299|< 0.0001
74083444|NCT01567527|147719769|SUPERIORITY|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|2.22|||||TWO_SIDED|95.0|1.475|3.34|||||HR is estimated for Placebo relative to Aripiprazole IM depot.|||3.34|1.475|
74083445|NCT01567527|147719770|SUPERIORITY|Using a hierarchical procedure to preserve the overall Type I error rate at 0.05, after testing the primary outcome.|Percentage Difference (Final Values)|-24.6|||<|0.0001|TWO_SIDED|95.0|-36.7|-12.5|||Fisher Exact|||Statistical analysis for any mood episode||-12.5|-36.7|< 0.0001
74083446|NCT01567527|147719771|SUPERIORITY|Using mixed model repeated measures (MMRM) analysis with a restricted maximum likelihood (REML) approach. Analyses included the categorically fixed effects of treatment, region, trial week, and treatment-by-week interaction, as well as the continuously fixed covariates of baseline-score-by-week interaction. An unstructured covariance structure was used to model the within-subject errors and Kenward-Rodger degree of freedom was used to test the fixed effects.|Mean Difference (Final Values)|-0.43|||=|0.0011|TWO_SIDED|95.0|-0.69|-0.17|||Mixed model repeated measure analysis|||||-0.17|-0.69|= 0.0011
74083447|NCT01567527|147719772|SUPERIORITY||Hazard Ratio (HR)|0.137|||=|0.0002|TWO_SIDED|95.0|0.04|0.465|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."|||0.465|0.04|= 0.0002
74083448|NCT01567527|147719772|SUPERIORITY|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|7.313|||||TWO_SIDED|95.0|2.151|24.865|||||HR is estimated for Placebo relative to Aripiprazole IM depot.|||24.865|2.151|
74083449|NCT02004691|147719774|SUPERIORITY||Least Squares Mean Difference|19.008|STANDARD_ERROR_OF_MEAN|4.7576|=|0.0004|TWO_SIDED|95.0|9.319|28.696||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% Confidence Interval (CI) and p-values were based on mixed model for repeated measures approach with Baseline Derived % Predicted DLco adjusted for Hb and pressure, age, treatment group, visit, and study visit by treatment group as covariates.|||28.696|9.319|=0.0004
74083450|NCT02004691|147719776|SUPERIORITY||Least Squares Mean Difference|-39.927|STANDARD_ERROR_OF_MEAN|3.4957|<|0.0001|TWO_SIDED|95.0|-47.051|-32.803||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values were based on a mixed model for repeated measures approach with Baseline Spleen Volume (MN), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|||-32.803|-47.051|<.0001
74083451|NCT02004691|147719778|SUPERIORITY||Least Squares Mean Difference|1.618|STANDARD_ERROR_OF_MEAN|3.3877|=|0.6364|TWO_SIDED|95.0|-5.302|8.538||Threshold for significance was 0.15.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Splenomegaly Related Score, Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|||8.538|-5.302|=0.6364
74083452|NCT02004691|147719783|SUPERIORITY||Least Squares Mean Difference|-26.596|STANDARD_ERROR_OF_MEAN|3.5862|<|0.0001|TWO_SIDED|95.0|-33.911|-19.281||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Liver Volume (MN), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||-19.281|-33.911|<.0001
74083453|NCT02004691|147719784|SUPERIORITY||Least Squares Mean Difference|14.332|STANDARD_ERROR_OF_MEAN|5.7822|=|0.0185|TWO_SIDED|95.0|2.564|26.099||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Platelets, Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||26.099|2.564|=0.0185
74083454|NCT02004691|147719785|SUPERIORITY||Least Squares Mean Difference|-0.056|STANDARD_ERROR_OF_MEAN|0.7384|=|0.94|TWO_SIDED|95.0|-1.566|1.454||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline BFI item 3 (Worst Fatigue), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||1.454|-1.566|=0.9400
74083455|NCT01320722|147719836|SUPERIORITY|||||||0.72|||||||Repeated Measures Analysis|||Week 8||||0.72
74083456|NCT01320722|147719837|SUPERIORITY|||||||0.77||||||Statistical significance was set for P\>0.05.|t-test, 2 sided|||Week 8||||0.77
74083457|NCT01320722|147719838|SUPERIORITY|||||||0.57||||||Statistical significance was set for P\>0.05.|t-test, 2 sided|||Week 8||||0.57
74083458|NCT01320722|147719839|SUPERIORITY|||||||0.8|||||||Repeated Measures Analysis|||||||0.8
74083459|NCT01320722|147719839|SUPERIORITY|||||||0.6|||||||Repeated Measures Analysis|||||||0.6
74083460|NCT01320722|147719840|SUPERIORITY|||||||0.6|||||||Repeated Measures Analysis|||||||0.6
74083461|NCT01320722|147719840|SUPERIORITY|||||||0.7|||||||Repeated Measures Analysis|||||||0.7
74083462|NCT01320722|147719841|SUPERIORITY|||||||0.3|||||||Repeated Measures Analysis|||||||0.3
74083463|NCT01320722|147719841|SUPERIORITY|||||||0.1|||||||Repeated Measures Analysis|||||||0.1
74083464|NCT01320722|147719842|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|Statistical significance was set for a 2-tailed P \<0.05.||Week 8||||0.35
74083465|NCT01320722|147719842|SUPERIORITY|||||||0.7||||||Statistical significance was set for a 2-tailed P \<0.05.|t-test, 2 sided|||Week 8||||0.7
74083466|NCT01320722|147719842|SUPERIORITY|||||||0.06||||||Statistical significance was set for a 2-tailed P \<0.05.|t-test, 2 sided|||Week 8||||0.06
74083467|NCT01320722|147719843|SUPERIORITY|||||||0.92||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Overall SBP||||0.92
74083468|NCT01320722|147719843|SUPERIORITY|||||||0.64||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Overall DBP||||0.64
74083469|NCT01320722|147719843|SUPERIORITY|||||||0.8||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Awake SBP||||0.80
74083470|NCT01320722|147719843|SUPERIORITY|||||||0.97||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Asleep SBP at Week 8||||0.97
74083471|NCT01320722|147719843|SUPERIORITY|||||||0.34|||||||Repeated Measures Analysis|||Overall SBP||||0.34
74083472|NCT01320722|147719843|SUPERIORITY|||||||0.59|||||||Repeated Measures Analysi|||Overall DBP||||0.59
74083473|NCT01320722|147719843|SUPERIORITY|||||||0.57|||||||Repeated Measures Analysis|||Awake SBF||||0.57
74083474|NCT01320722|147719843|SUPERIORITY|||||||0.08|||||||Repeated Measures Analysis|||Asleep SBP||||0.08
74083475|NCT01320722|147719843|SUPERIORITY|||||||0.59|||||||Repeated Measures Analysis|||Overall SBP||||0.59
74083476|NCT01320722|147719843|SUPERIORITY|||||||0.53|||||||Repeated Measures Analysis|||||||0.53
74083477|NCT01320722|147719843|SUPERIORITY|||||||0.55|||||||Repeated Measures Analysis|||Awake SBP||||0.55
74083478|NCT01320722|147719843|SUPERIORITY|||||||0.8|||||||Repeated Measures Analysis|||Asleep SBP||||0.80
74083479|NCT01320722|147719844|SUPERIORITY|||||||0.98|||||||Repeated Measures Analysis|||||||0.98
74083480|NCT01320722|147719844|SUPERIORITY|||||||0.07|||||||Repeated Measures Analysis|||||||0.07
74083481|NCT01320722|147719844|SUPERIORITY|||||||0.97|||||||Repeated Measures Analysis|||||||0.97
74083482|NCT00784095|147719855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.047|TWO_SIDED|95.0|0.04|5.7|||Mixed Models Analysis|||Intervention (Preparation and Completion) versus True Control at 8 weeks||5.7|.04|.047
74083483|NCT00784095|147719855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|||||TWO_SIDED|95.0|-1.1|4.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||4.7|-1.1|
74083484|NCT00784095|147719856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-3.2|5.6||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||5.6|-3.2|
74083485|NCT00784095|147719856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-5.6|3.3||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||3.3|-5.6|
74083486|NCT00784095|147719857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-6.2|2.9||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||2.9|-6.2|
74083487|NCT00784095|147719857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|||||TWO_SIDED|95.0|-8.2|1.0||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||1.0|-8.2|
74083488|NCT00784095|147719858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-4.5|3.4||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||3.4|-4.5|
74083489|NCT00784095|147719858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-5.1|3.0||||||Intervention versus Attention Control at 8 weeks.||3.0|-5.1|
74083490|NCT00784095|147719859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-4.8|3.7||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||3.7|-4.8|
74083491|NCT00784095|147719859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-1.9|6.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks.||6.7|-1.9|
74083492|NCT01540045|147719861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.013
74083493|NCT01540045|147719862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.671|TWO_SIDED||||||t-test, 2 sided|||we evaluated body fat before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy||||0.671
74083494|NCT01540045|147719862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.694|TWO_SIDED||||||t-test, 2 sided|||we evaluated lean body mass before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy||||0.694
74083495|NCT01540045|147719863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118|TWO_SIDED||||||t-test, 2 sided|||||||0.118
74083496|NCT01540045|147719864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.607|TWO_SIDED||||||McNemar|||Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).||||0.607
74083497|NCT01540045|147719865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds compared to \< Sweet perception thresholds after chemotherapy||||0.015
74083498|NCT01540045|147719865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||animal protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy||||0.010
74083499|NCT01540045|147719865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||FAT consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy||||0.004
74083500|NCT01540045|147719867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.28
74083501|NCT01540045|147719868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.889|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.889
74083502|NCT01540045|147719868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in functional role of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.293
74083503|NCT01540045|147719868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in emotional functioning of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.009
74083504|NCT01540045|147719868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.213|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in fatigue scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.213
74083505|NCT01540045|147719868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.595|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in appetite loss of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.595
74083506|NCT01540045|147719868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in constipation scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.068
74083507|NCT01540045|147719869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
74083508|NCT01540045|147719870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in peripheral neuropathy scale of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire||||0.240
74083509|NCT01540045|147719871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire||||0.036
74083510|NCT01540045|147719872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.312
74083511|NCT01540045|147719873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.608|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.608
74083512|NCT01540045|147719874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.035
74083513|NCT01540045|147719875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.402|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.402
74083514|NCT01540045|147719876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.109|TWO_SIDED||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.||||0.109
74083515|NCT01540045|147719877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092|TWO_SIDED||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.||||0.092
74083516|NCT01540045|147719878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||McNemar|||We divide dilutions in two groups and dichotomized the patients into high and low sensibility to bitter taste. (PERCEPTION)||||0.022
74083517|NCT00936351|147719879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||.04
74083518|NCT03828539|147719889|OTHER||Odds Ratio (OR)|0.19|||<|0.001|TWO_SIDED|95.0|0.13|0.27|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||0.27|0.13|<.001
74083519|NCT03828539|147719890|OTHER||Odds Ratio (OR)|2.76|||<|0.001|TWO_SIDED|95.0|2.06|3.71|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||3.71|2.06|<.001
74083520|NCT03828539|147719891|OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.7|3.12|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||3.12|1.70|<.001
74083521|NCT03828539|147719892|OTHER||Odds Ratio (OR)|1.75|||<|0.001|TWO_SIDED|95.0|1.26|2.43|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||Physical Component Summary (PCS)||2.43|1.26|<0.001
74083522|NCT03828539|147719892|OTHER||Odds Ratio (OR)|1.79||||0.005|TWO_SIDED|95.0|1.29|2.69|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||Mental Component Summary (MCS)||2.69|1.29|0.005
74083523|NCT00830167|147719914|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.17||0.0046|TWO_SIDED|95.0|-0.78|-0.11||The analysis was conducted using 1-sided test with the significance level of 0.025. Actual significance level was calculated based on O'Brien-Fleming type alpha spending function of Lan and DeMets (1983).|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.11|-0.78|0.0046
74083524|NCT00830167|147719915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED|||||The analysis was conducted using 2-sided test with the significance level of 0.05.|Chi-squared|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that there was a difference between the pregabalin and the placebo groups.||||0.0078
74083525|NCT00830167|147719916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.48|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-13.12|-5.85||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-5.85|-13.12|<0.0001
74083526|NCT00830167|147719917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.98|STANDARD_ERROR_OF_MEAN|1.88||0.9958|TWO_SIDED|95.0|1.29|8.68||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||8.68|1.29|0.9958
74083527|NCT00830167|147719918|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.99|STANDARD_ERROR_OF_MEAN|1.92||0.0049|TWO_SIDED|95.0|-8.77|-1.21||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-1.21|-8.77|0.0049
74083528|NCT00830167|147719919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.09||0.0007|TWO_SIDED|95.0|0.11|0.47||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.47|0.11|0.0007
74083529|NCT00830167|147719920|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.48|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|3.58|11.38||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||11.38|3.58|<0.0001
74083530|NCT00830167|147719921|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.31|STANDARD_ERROR_OF_MEAN|1.82||1|TWO_SIDED|95.0|7.74|14.87||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||14.87|7.74|1.0000
74083531|NCT00830167|147719922|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|1.35||0.0137|TWO_SIDED|95.0|-5.65|-0.33||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.33|-5.65|0.0137
74083532|NCT00830167|147719923|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.0687|TWO_SIDED|95.0|0.9|2.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|Regression, Logistic|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||2.35|0.90|0.0687
74083533|NCT00830167|147719924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.06|-0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.40|-1.06|<0.0001
74083534|NCT00830167|147719925|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.33|STANDARD_ERROR_OF_MEAN|1.52||0.0144|TWO_SIDED|95.0|-6.31|-0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.35|-6.31|0.0144
74083535|NCT00830167|147719926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.0376|TWO_SIDED|95.0|-0.59|0.03||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.03|-0.59|0.0376
74083536|NCT00830167|147719927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.25||0.0052|TWO_SIDED|95.0|-1.12|-0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.15|-1.12|0.0052
74083537|NCT00830167|147719928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.4768|TWO_SIDED|95.0|-0.42|0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.40|-0.42|0.4768
74083538|NCT00830167|147719929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.21||0.0729|TWO_SIDED|95.0|-0.74|0.11||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.11|-0.74|0.0729
74083539|NCT00830167|147719930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.21||0.0238|TWO_SIDED|95.0|-0.81|0.0||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.00|-0.81|0.0238
74083540|NCT00830167|147719931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0075|TWO_SIDED|95.0|-0.89|-0.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.10|-0.89|0.0075
74083541|NCT00830167|147719932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.21||0.0023|TWO_SIDED|95.0|-1.01|-0.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.18|-1.01|0.0023
74083542|NCT00830167|147719933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.2568|TWO_SIDED|95.0|-0.57|0.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.29|-0.57|0.2568
74083543|NCT00830167|147719934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.22||0.1011|TWO_SIDED|95.0|-0.72|0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.15|-0.72|0.1011
74083544|NCT00830167|147719935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.2||0.4165|TWO_SIDED|95.0|-0.44|0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.35|-0.44|0.4165
74083545|NCT00830167|147719936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.29|STANDARD_ERROR_OF_MEAN|1.32||0.0006|TWO_SIDED|95.0|1.7|6.88||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||6.88|1.70|0.0006
74083546|NCT00830167|147719937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|1.84||0.1805|TWO_SIDED|95.0|-1.93|5.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.29|-1.93|0.1805
74083547|NCT00830167|147719938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|1.5||0.077|TWO_SIDED|95.0|-0.81|5.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.10|-0.81|0.0770
74083548|NCT00830167|147719939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83|STANDARD_ERROR_OF_MEAN|1.2||0.0648|TWO_SIDED|95.0|-0.54|4.19||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||4.19|-0.54|0.0648
74083549|NCT00830167|147719940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.94||0.2068|TWO_SIDED|95.0|-2.23|5.41||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.41|-2.23|0.2068
73959263|NCT03257813|147454517|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||baseline|Chi-squared|||||||1.000
73836890|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.45|0.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.78|0.45|
73836891|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.84|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.62|0.84|
73836892|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.45|0.87||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.87|0.45|
74083550|NCT00830167|147719941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.92||0.548|TWO_SIDED|95.0|-4.0|3.54||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||3.54|-4.00|0.5480
74083551|NCT00830167|147719942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.42|STANDARD_ERROR_OF_MEAN|1.72||0.0052|TWO_SIDED|95.0|1.04|7.8||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||7.80|1.04|0.0052
74083552|NCT00830167|147719943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64|STANDARD_ERROR_OF_MEAN|1.39||0.0287|TWO_SIDED|95.0|-0.08|5.37||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.37|-0.08|0.0287
74083553|NCT00830167|147719944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.25||0.0262|TWO_SIDED|95.0|-0.97|0.01||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.01|-0.97|0.0262
74083554|NCT00830167|147719945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.28||0.1561|TWO_SIDED|95.0|-0.83|0.27||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.27|-0.83|0.1561
74083555|NCT00830167|147719946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.19|STANDARD_ERROR_OF_MEAN|2.04||0.0013|TWO_SIDED|95.0|-10.2|-2.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-2.18|-10.20|0.0013
74083556|NCT02224053|147719947|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|106.66|||||TWO_SIDED|90.0|100.26|113.46|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.||113.46|100.26|
74083557|NCT02224053|147719948|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|101.65|||||TWO_SIDED|90.0|94.65|109.16|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.||109.16|94.65|
74083558|NCT02224053|147719957|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.79|||||TWO_SIDED|90.0|88.77|101.21||||||AZ5104||101.21|88.77|
74083559|NCT02224053|147719957|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geomteric mean ratio|89.7|||||TWO_SIDED|90.0|83.89|95.91||||||AZ7550||95.91|83.89|
74083560|NCT02224053|147719958|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|102.32|||||TWO_SIDED|90.0|96.87|108.07|||||AZD9291+omeprazole / AZD9291 alone|AZ5104||108.07|96.87|
74083561|NCT02224053|147719958|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.03|||||TWO_SIDED|90.0|89.92|98.33||||||AZ7550||98.33|89.92|
74083562|NCT01898598|147719971|SUPERIORITY_OR_OTHER||Difference in Clinical Response Rates|-21.8|||||TWO_SIDED|95.0|-71.6|32.1||||||The 95 % confidence interval (CI) for the difference in response rates was computed using the exact unconditional confidence limits method.||32.1|-71.6|
74083563|NCT01898598|147719972|SUPERIORITY_OR_OTHER||Percentage Difference|-40.0|||||TWO_SIDED|95.0|-85.3|14.2||||||||14.2|-85.3|
74083564|NCT00860262|147719983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|1.18|<|0.0001|TWO_SIDED|95.0|-12.9|-8.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus Telmisartan 80 mg|||-8.3|-12.9|<0.0001
74083565|NCT00860262|147719983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.18||0.0002|TWO_SIDED|95.0|-6.7|-2.1|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.1|-6.7|0.0002
74083566|NCT00860262|147719984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|1.25|<|0.0001|TWO_SIDED|95.0|-13.1|-8.2|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-8.2|-13.1|<0.0001
74083567|NCT00860262|147719984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.24||0.0001|TWO_SIDED|95.0|-7.3|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.4|-7.3|0.0001
73836893|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.36|0.79||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.79|0.36|
73836894|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.71|1.4||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.40|0.71|
74083568|NCT00860262|147719985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-12.6|-7.7|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-7.7|-12.6|<0.0001
74083569|NCT00860262|147719985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.24||0.0001|TWO_SIDED|95.0|-7.2|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.4|-7.2|0.0001
74083570|NCT00860262|147719986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-10.2|-5.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-5.4|-10.2|<0.0001
74083571|NCT00860262|147719986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.0|-2.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.3|-7.0|0.0001
73898349|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|7.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898350|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.936||0.671|TWO_SIDED|95.0|-2.239|1.443||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.443|-2.239|0.671
73836895|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.66|1.31||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.31|0.66|
74083572|NCT00860262|147719987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED|95.0|-8.8|-4.0|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-4.0|-8.8|<0.0001
74083573|NCT00860262|147719987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.23||0.0077|TWO_SIDED|95.0|-5.7|-0.9|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-0.9|-5.7|0.0077
74083574|NCT00633022|147720024|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.4519|TWO_SIDED|95.0|-0.14|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.ANCOVA model, fitting fixed effect treatment term,|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg BID versus Placebo||0.06|-0.14|0.4519
74083575|NCT00633022|147720024|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.5789|TWO_SIDED|95.0|-0.11|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo||0.06|-0.11|0.5789
74083576|NCT00633022|147720025|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.6986|TWO_SIDED|95.0|-0.15|0.1|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg twice daily versus placebo||0.10|-0.15|0.6986
74083577|NCT00633022|147720025|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9486|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo||0.12|-0.13|0.9486
74083578|NCT04388787|147720034|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
74083579|NCT04388787|147720035|SUPERIORITY|||||||0.0008|||||||ANCOVA|||||||0.0008
74083580|NCT00688844|147720036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.655574|STANDARD_DEVIATION|8.060658||0.692782|||||||t-test, 2 sided|||Objective was to evaluate BMI across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.692782
74083581|NCT00688844|147720037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005401|STANDARD_DEVIATION|0.0243|<|0.001|||||||t-test, 2 sided|||Objective was to evaluate total body bone mineral density (BMD) one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||<0.001
74083582|NCT00688844|147720038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.419224|STANDARD_DEVIATION|3.4666||0.017941|||||||t-test, 2 sided|||Objective was to evaluate % lean mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.017941
74083583|NCT00688844|147720039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.208889|STANDARD_DEVIATION|3.51967||0.026009|||||||t-test, 2 sided|||Objective was to evaluate % fat mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.026009
74083584|NCT00688844|147720040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.5187|STANDARD_DEVIATION|362.9412||0.303864|||||||t-test, 2 sided|||Objective was to evaluate plasma phenylalanine across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.303864
74083585|NCT00688844|147720041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9549|STANDARD_DEVIATION|20.10814||0.00088|||||||t-test, 2 sided|||Objective was to evaluate protein intake (grams per day) across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.00088
74083586|NCT00688844|147720042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131676|STANDARD_DEVIATION|0.797247||0.3811|||||||t-test, 2 sided|||Objective was to evaluate dietary phenylalanine intake across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.3811
74083587|NCT01374451|147720044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.991||||0.488|TWO_SIDED|95.0|0.636|1.543|||Log Rank|||||1.543|0.636|0.488
74083588|NCT04729101|147720102|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|38.98|||||TWO_SIDED|95.0|31.94|46.02||||||Vonoprazan versus lansoprazole on Day 1 of each treatment period.||46.02|31.94|
74083589|NCT04729101|147720102|OTHER|Additional statistics were descriptive in nature|Least-squares mean difference|44.62|||||TWO_SIDED|95.0|37.55|51.69||||||Vonoprazan versus lansoprazole on Day 7 of each treatment period.||51.69|37.55|
74083590|NCT04729101|147720103|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|1.72|||||TWO_SIDED|95.0|1.4|2.04||||||Vonoprazan versus lansoprazole on Day 1 of each treatment period.||2.04|1.40|
74083591|NCT04729101|147720103|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|2.09|||||TWO_SIDED|95.0|1.74|2.44||||||Vonoprazan versus lansoprazole on Day 7 of each treatment period.||2.44|1.74|
74083592|NCT02940522|147720111|OTHER|Comparison of bioavailability|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
74083593|NCT02940522|147720112|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
74083594|NCT02940522|147720113|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
74083595|NCT02940522|147720114|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
73959264|NCT03257813|147454517|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.391||||||Cross Over|Chi-squared|||||||0.391
73959265|NCT03257813|147454517|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.534||||||Final Visit|Chi-squared|||||||0.534
74083596|NCT02940522|147720115|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
74083597|NCT02940522|147720116|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
74083598|NCT00274625|147720117|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Fisher Exact|||||||0.60
74083599|NCT02959840|147720118|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.|||||<|1e-05|||||||Chi-squared|||||||< 0.00001
73836896|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.63|1.39||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.63|
73836897|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.41|0.7||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.70|0.41|
74083600|NCT02959840|147720118|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||5e-05|||||||Chi-squared|||||||0.00005
74083601|NCT02959840|147720118|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
74083602|NCT02959840|147720119|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared|||||||0.001
74083603|NCT02959840|147720119|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0002|||||||Chi-squared|||||||0.0002
73959266|NCT03257813|147454518|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.023||||||Baseline|Chi-squared, Corrected|||||||0.023
73959267|NCT03257813|147454518|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared|||||||1.000
73836898|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.82|1.38||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.38|0.82|
73959268|NCT03257813|147454518|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.793||||||Final Visit|Chi-squared|||||||0.793
73959269|NCT03257813|147454519|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.825||||||Baseline|Chi-squared|||||||0.825
73898351|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|7.59|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73959270|NCT03257813|147454519|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared|||||||1.000
73959271|NCT03257813|147454519|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.765|||||||Chi-squared|||||||0.765
73836899|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|1.46|2.69||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.69|1.46|
73836900|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.74|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.28|0.74|
73836901|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.59|1.02||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.02|0.59|
73836902|NCT01026038|147222736|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.58|1.1||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.10|0.58|
73959272|NCT02878330|147454520|SUPERIORITY||Relative Risk Reduction|70.1|||<|0.0001|TWO_SIDED|95.0|52.3|81.2|||Poisson regression|||||81.2|52.3|<0.0001
73959273|NCT02878330|147454521|SUPERIORITY||Relative Risk Reduction|78.4||||0.0002|TWO_SIDED|95.0|51.9|90.3|||Poisson regression|||||90.3|51.9|0.0002
73836903|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.7||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.5|
73836904|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
73959274|NCT04673851|147454527|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.86|STANDARD_DEVIATION|5.44|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
73898352|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.964||0.231|TWO_SIDED|95.0|-3.052|0.738||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.738|-3.052|0.231
73898353|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|7.25|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898354|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|2.47|STANDARD_ERROR_OF_MEAN|1.137||0.031|TWO_SIDED|95.0|0.23|4.701||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||4.701|0.230|0.031
73836905|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.8|6.6||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.8|
73959275|NCT04673851|147454527|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.16|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
73959276|NCT04673851|147454527|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.65|STANDARD_DEVIATION|5.61|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
73836906|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.3||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.7|
73898355|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|0.29|STANDARD_DEVIATION|8.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898356|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|0.68|STANDARD_ERROR_OF_MEAN|1.124||0.547|TWO_SIDED|95.0|-1.532|2.888||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.888|-1.532|0.547
73898357|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|9.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73959277|NCT04673851|147454527|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.47|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
73959278|NCT04673851|147454527|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-1.97|STANDARD_DEVIATION|7.19|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
73959279|NCT04673851|147454527|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.27|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
73959280|NCT04673851|147454527|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-4.15|STANDARD_DEVIATION|7.93|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
73898358|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|0.73|STANDARD_ERROR_OF_MEAN|1.145||0.524|TWO_SIDED|95.0|-1.521|2.984||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.984|-1.521|0.524
73959281|NCT04673851|147454527|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.52|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
73959282|NCT04673851|147454528|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-1.52|STANDARD_DEVIATION|8.95|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
73959283|NCT04673851|147454528|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.17|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
74083604|NCT02959840|147720119|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.8|||||||Chi-squared|||||||0.8
74083605|NCT02959840|147720120|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||4e-05|||||||Chi-squared|||||||0.00004
74083606|NCT02959840|147720120|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.0004|||||||Chi-squared|||||||0.0004
74083607|NCT02959840|147720120|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.09|||||||Chi-squared|||||||0.09
74083608|NCT02959840|147720121|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
74083609|NCT02959840|147720121|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.07|||||||Chi-squared|||||||0.07
74083610|NCT02959840|147720121|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
74083611|NCT02959840|147720122|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
74083612|NCT02959840|147720122|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
74083613|NCT02959840|147720122|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
74083614|NCT02959840|147720123|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||1|||||||Chi-squared|||||||1
74083615|NCT02959840|147720123|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
74083616|NCT02959840|147720123|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
74083617|NCT02959840|147720124|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared|||||||0.001
74083618|NCT02959840|147720124|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0004|||||||Chi-squared|||||||0.0004
74083619|NCT02959840|147720124|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared|||||||1
74083620|NCT02959840|147720125|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.008|||||||Chi-squared|||||||0.008
74083621|NCT02959840|147720125|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.07|||||||Chi-squared|||||||0.07
74083622|NCT02959840|147720125|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.6|||||||Chi-squared|||||||0.6
74083623|NCT02959840|147720126|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
74083624|NCT02959840|147720126|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
74083625|NCT02959840|147720126|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
74083626|NCT02959840|147720127|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
74083627|NCT02959840|147720127|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared|||||||1
74083628|NCT02959840|147720127|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
74083629|NCT02959840|147720128|SUPERIORITY|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.02|||||||Fisher Exact|||||||0.02
74083630|NCT02959840|147720128|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact|||||||0.2
74083631|NCT02959840|147720128|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.3|||||||Fisher Exact|||||||0.3
74083632|NCT02959840|147720129|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact|||||||0.2
74083633|NCT02959840|147720129|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.5|||||||Fisher Exact|||||||0.5
74083634|NCT02959840|147720129|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.7|||||||Fisher Exact|||||||0.7
74083635|NCT00122447|147720204|SUPERIORITY_OR_OTHER||Slope|-0.941|STANDARD_ERROR_OF_MEAN|1.229||0.449|TWO_SIDED|95.0|-3.435|1.552||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||1.552|-3.435|0.449
74083636|NCT00122447|147720204|SUPERIORITY_OR_OTHER||Slope|-2.677|STANDARD_ERROR_OF_MEAN|1.211||0.034|TWO_SIDED|95.0|-5.133|-0.221||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||-0.221|-5.133|0.034
74083637|NCT00122447|147720204|SUPERIORITY_OR_OTHER||Slope|0.088|STANDARD_ERROR_OF_MEAN|1.21||0.943|TWO_SIDED|95.0|-2.367|2.542||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||2.542|-2.367|0.943
74083638|NCT00122447|147720205|SUPERIORITY_OR_OTHER||Slope|-0.001|STANDARD_ERROR_OF_MEAN|0.012||0.943|TWO_SIDED|95.0|-0.025|0.023||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||Null hypothesis: no difference between active treatment group compared to placebo.||0.023|-0.025|0.943
74083639|NCT00122447|147720205|SUPERIORITY_OR_OTHER||Slope|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.28|TWO_SIDED|95.0|-0.012|0.039||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||||0.039|-0.012|0.280
74083640|NCT00122447|147720205|SUPERIORITY_OR_OTHER||Slope|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.313|TWO_SIDED|95.0|-0.012|0.037||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||||0.037|-0.012|0.313
74083641|NCT01453153|147720225|SUPERIORITY||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|60.0||||||||60|0|
74083642|NCT01453153|147720225|SUPERIORITY||percentage of participants|50.0|||||TWO_SIDED|95.0|7.0|93.0||||||||93|7|
74083643|NCT01453153|147720225|SUPERIORITY||percentage of participants|40.0|||||TWO_SIDED|95.0|19.0|64.0||||||||64|19|
74083644|NCT01453153|147720226|SUPERIORITY||percentage of participants|25.0|||||TWO_SIDED|95.0|1.0|81.0||||||||81|1|
74083645|NCT01453153|147720226|SUPERIORITY||percentage of participants|100.0|||||TWO_SIDED|95.0|40.0|100.0||||||||100|40|
74083646|NCT01453153|147720226|SUPERIORITY||percentage of participants|70.0|||||TWO_SIDED|95.0|46.0|88.0||||||||88|46|
74083647|NCT00880334|147720235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.939|TWO_SIDED|95.0|0.69|1.49|||Log Rank|||The study was designed with 80% power to detect 60% improvement in median PFS from 18 to 28.8 weeks (Vandetanib+docetaxel/Placebo+docetaxel hazard ratio of 0.625) with the addition of Vandetanib while maintaining an overall significance level of 5% in a one-sided test. This assumed exponential distribution of events, accrual of 1.75 patients per week (7-8 patients per month) for 78 weeks with 34 weeks of additional follow-up (112 weeks total). Full information was 118 PFS events.||1.49|0.69|0.939
74083648|NCT00880334|147720237|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.873|TWO_SIDED|95.0|0.81|1.79|||Log Rank|||||1.79|0.81|.873
74083649|NCT00880334|147720238|SUPERIORITY_OR_OTHER|||||||0.56|||||||Fisher Exact|||||||0.56
74083650|NCT00880334|147720239|SUPERIORITY_OR_OTHER|||||||0.31|||||||Fisher Exact|||||||0.31
74083651|NCT05061992|147720242|SUPERIORITY|||||||0.6|||||||ANCOVA|||Change in SF-8||||0.6
74083652|NCT05061992|147720242|SUPERIORITY|||||||0.2|||||||ANCOVA|||End of trial SF-8||||0.2
74083653|NCT05061992|147720243|SUPERIORITY|||||||0.001|||||||ANCOVA|||Change in ANT||||0.001
74083654|NCT05061992|147720243|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||End of trial ANT||||0.09
74083655|NCT05061992|147720244|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
74083656|NCT05061992|147720245|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
73898359|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|8.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
74083657|NCT05061992|147720246|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.6
74083658|NCT05061992|147720247|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
73898360|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.356||0.54|TWO_SIDED|95.0|-3.499|1.836||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.836|-3.499|0.540
73898361|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|10.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898362|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.336||0.664|TWO_SIDED|95.0|-3.208|2.046||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.046|-3.208|0.664
73898363|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|10.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898364|NCT02880956|147328889|SUPERIORITY||LS Mean of Difference|-1.19|STANDARD_ERROR_OF_MEAN|1.39||0.393|TWO_SIDED|95.0|-3.923|1.546||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.546|-3.923|0.393
73836907|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
73836908|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.4|6.5||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.4|
73836909|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
73836910|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
73836911|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
73836912|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.6||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.7|
73836913|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.7|
73836914|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
73836915|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
73836916|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.3||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.7|
73836917|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.6|6.4||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-6.6|
73836918|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|-1.7|||||TWO_SIDED|95.0|-6.2|4.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||4.5|-6.2|
73836919|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.1|||||TWO_SIDED|95.0|-4.8|7.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||7.5|-4.8|
73898365|NCT02880956|147328889|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|9.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898366|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.262||0.946|TWO_SIDED|95.0|-0.534|0.498||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.498|-0.534|0.946
73836920|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|1.8|||||TWO_SIDED|95.0|-4.8|9.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||9.5|-4.8|
73836921|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.7||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.5|
74083659|NCT02274558|147720257|OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.2|-2.0|||Mixed-effect Model Repeated Measures|||"Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:~* AIMS dyskinesia total score mean change from baseline (CFB): valbenazine 80 mg vs. placebo.~* CGI-TD mean score: VBZ 80 mg vs. PBO.~* AIMS: VBZ 40 mg vs. PBO.~* CGI-TD: VBZ 40 mg vs. PBO.~For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance."||-2.0|-4.2|<0.0001
74083660|NCT02274558|147720257|OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.0021|TWO_SIDED|95.0|-3.0|-0.7||Nominal P-value, not adjusted for multiplicity. See comments in above statistical analysis overview regarding the fixed-sequence testing procedure to control for multiplicity.|Mixed-effect Model Repeated Measures|||||-0.7|-3.0|0.0021
74083661|NCT02274558|147720258|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0742|TWO_SIDED|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures|||||0.0|-0.5|0.0742
74083662|NCT02274558|147720258|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.056|TWO_SIDED|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures|||||0.0|-0.5|0.0560
74083663|NCT02274558|147720259|OTHER|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.0200
74083664|NCT02274558|147720259|OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74083665|NCT04968925|147720338|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|4.24|||||TWO_SIDED|95.0|0.8|22.54|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||22.54|0.80|
74083666|NCT04968925|147720339|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|3.44|||||TWO_SIDED|95.0|1.16|10.16|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||10.16|1.16|
74083667|NCT04968925|147720340|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.05|6.76|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||6.76|1.05|
74083668|NCT04968925|147720341|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.76|||||TWO_SIDED|98.33|1.09|2.83|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.83|1.09|
74083669|NCT04968925|147720342|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.52|||||TWO_SIDED|96.66|1.02|2.28|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.28|1.02|
74083670|NCT04968925|147720343|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.77|2.03|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.03|0.77|
74083671|NCT00487695|147720355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|95.0|||||Wilcoxon signed rank|||Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. We estimated that the yield for neoplasia would increase from 10% to 40% using CLE and the calculated sample size was 37. We planned to enroll 48 patients to allow for possible dropouts.||||0.01
74083672|NCT00487695|147720356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89||95.0|||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared.||||0.89
74083673|NCT00487695|147720357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||wilcoxon signed rank test|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy||||0.002
74083674|NCT00487695|147720359|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared. This analysis looks at the patients referred for Barrett's surveillance EGD (no suspected neoplasia).||||1.0
74083675|NCT00487695|147720360|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed-rank|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy||||<0.0001
74083676|NCT04542694|147720361|SUPERIORITY||The difference in proportions|0.1313||||0.0372|TWO_SIDED|95.0|-0.0004|0.2367|||Chi-squared|||A comparative analysis of the rate of clinical status improvement by 2 or more categories. The difference in percentages between the AREPLIVIR arm and the standard therapy arm (pa-pb)||0.2367|-0.0004|0.0372
73959284|NCT04673851|147454528|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.15|STANDARD_DEVIATION|5.8|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
73959285|NCT04673851|147454528|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.2|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
73959286|NCT04673851|147454528|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|0.67|STANDARD_DEVIATION|10.29|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
73959287|NCT04673851|147454528|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.07|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
73959288|NCT04673851|147454528|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.07|STANDARD_DEVIATION|9.47|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
73959289|NCT04673851|147454528|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.22|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
73959290|NCT04673851|147454529|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.05|STANDARD_DEVIATION|7.08|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
74083677|NCT04542694|147720362|SUPERIORITY||The difference in days|4.0|||<|0.0001|TWO_SIDED||||||Log Rank|||Comparative analysis of time to clinical status improvement by categorical ordinal clinical improvement scale between the AREPLIVIR arm and the standard therapy arm||||<0.0001
74083678|NCT04542694|147720363|SUPERIORITY||The difference in percentages|22.5||||0.00016|TWO_SIDED||||||Chi-squared|||||||0.00016
74083679|NCT04542694|147720364|SUPERIORITY||Median Difference (Final Values)|1.55||||0.052|TWO_SIDED||||||Log Rank|||||||0.052
74083680|NCT04542694|147720365|SUPERIORITY|||||||0.1953|||||||Chi-squared|||||||0.1953
74083681|NCT04542694|147720366|SUPERIORITY|||||||0.4975|||||||Chi-squared|||||||0.4975
74083682|NCT00687739|147720376|SUPERIORITY|The primary analysis compared the GnRHAG + E2 and GnRHAG + PL groups, pooled across exercise status. It was acknowledged that the inclusion of exercisers could minimize the effects of GnRHAG but would be reflective of the effects of ovarian hormone suppression on sedentary and active women. Differences in changes across time between groups were tested using an analysis of covariance model conditioned on baseline.|||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the effect of PL vs E2 collapsed across exercise (2-group comparison). The analysis of effects of exercise was exploratory (evaluated within-group changes only).||||<0.05
74083683|NCT00687739|147720377|SUPERIORITY||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the comparison of within-group changes in the E2 and placebo groups for cortisol AUC in response to Dex/CRH and between-group differences in the changes. Within-group changes and between-group differences in changes were evaluated by linear contrast using an ANCOVA model with adjustment for pre-intervention values of outcomes.||||<0.05
74083684|NCT00687739|147720378|SUPERIORITY||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis compared the GnRHag+E2 and GnRHag+PL groups, pooled across exercise status. Differences in change over time between groups were tested by using an ANCOVA model, first with treatment group alone, and again adding FM and FFM to the model.||||<0.05
74083685|NCT01957150|147720397|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95 % confidence interval (CI) for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.46|||||TWO_SIDED|95.0|-0.97|0.06|||||Treatment comparison for overall weeks|||0.06|-0.97|
74083686|NCT01957150|147720398|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.47|||||TWO_SIDED|95.0|-1.17|0.24|||||Overall Weeks for Male|||0.24|-1.17|
73959291|NCT04673851|147454529|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.01|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
73959292|NCT04673851|147454529|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.35|STANDARD_DEVIATION|7.53|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
73959293|NCT04673851|147454529|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.31|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
73959294|NCT04673851|147454529|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|0.9|STANDARD_DEVIATION|9.95|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
74083687|NCT01957150|147720399|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.4|||||TWO_SIDED|95.0|-1.16|0.36|||||Overall Weeks for female|||0.36|-1.16|
74083688|NCT01957150|147720400|OTHER||Percentage Change from Baseline|-1.02|||||TWO_SIDED|95.0|-1.9|-0.13|||||Overall Weeks for Male|||-0.13|-1.90|
74083689|NCT01957150|147720401|OTHER||Percentage Change from Baseline|-0.05|||||TWO_SIDED|95.0|-0.87|0.78|||||Overall Weeks for female|||0.78|-0.87|
74083690|NCT01957150|147720402|OTHER||Percentage Change from Baseline|-0.51|||||TWO_SIDED|95.0|-1.11|0.1|||||Overall week|||0.10|-1.11|
74083691|NCT01207752|147720403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.550
74083692|NCT01332968|147720442|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.0012|TWO_SIDED|95.0|0.51|0.85|||Log Rank|Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.||||0.85|0.51|0.0012
73959295|NCT04673851|147454529|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.09|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
73959296|NCT04673851|147454529|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.56|STANDARD_DEVIATION|9.6|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
73959297|NCT04673851|147454529|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.27|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
73959298|NCT04673851|147454530|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.29|STANDARD_DEVIATION|8.27|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
73959299|NCT04673851|147454530|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.04|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
73959300|NCT04673851|147454530|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.6|STANDARD_DEVIATION|7.86|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
73959301|NCT04673851|147454530|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
73898367|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898368|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.259||0.242|TWO_SIDED|95.0|-0.813|0.206||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.206|-0.813|0.242
73898369|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|2.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898370|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.266||0.541|TWO_SIDED|95.0|-0.685|0.36||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.360|-0.685|0.541
73898371|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898372|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.298||0.724|TWO_SIDED|95.0|-0.481|0.691||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.691|-0.481|0.724
73898373|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898374|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.29||0.236|TWO_SIDED|95.0|-0.226|0.913||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.913|-0.226|0.236
73898375|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|2.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898376|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.298||0.714|TWO_SIDED|95.0|-0.477|0.695||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.695|-0.477|0.714
73898377|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|2.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898378|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.277||0.86|TWO_SIDED|95.0|-0.496|0.593||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.593|-0.496|0.860
73898379|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898380|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.274||0.476|TWO_SIDED|95.0|-0.733|0.343||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.343|-0.733|0.476
73898381|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|2.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898382|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.276||0.586|TWO_SIDED|95.0|-0.393|0.694||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.694|-0.393|0.586
73898383|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898384|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.324||0.412|TWO_SIDED|95.0|-0.371|0.903||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.903|-0.371|0.412
73898385|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|2.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
74083693|NCT01332968|147720443|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0055|TWO_SIDED|95.0|0.64|0.93|||Log Rank|Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.||||0.93|0.64|0.0055
73898386|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.319||0.45|TWO_SIDED|95.0|-0.386|0.868||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.868|-0.386|0.450
74083694|NCT01332968|147720444|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0028|TWO_SIDED|95.0|0.65|0.91|||Log Rank|||||0.91|0.65|0.0028
74083695|NCT01332968|147720445|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0118|TWO_SIDED|95.0|0.56|0.93|||Log Rank|||||0.93|0.56|0.0118
74083696|NCT01332968|147720446|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0038||95.0|0.57|0.9|||Log Rank|||||0.90|0.57|0.0038
74083697|NCT01332968|147720447|SUPERIORITY||Absolute difference in %|1.8||||0.3|TWO_SIDED|95.0|-2.02|5.68|||Log Rank|||Without PET||5.68|-2.02|0.30
74083698|NCT01332968|147720447|SUPERIORITY||Absolute difference in %|4.3||||0.17|TWO_SIDED|95.0|-1.8|10.5|||Log Rank|||With PET||10.5|-1.8|0.17
74083699|NCT01332968|147720448|SUPERIORITY||Absolute difference in %|1.6||||0.33|TWO_SIDED|95.0|-2.0|5.3|||Log Rank|||Without PET||5.3|-2.0|0.33
74083700|NCT01332968|147720448|SUPERIORITY||Absolute difference in %|3.5||||0.17|TWO_SIDED|95.0|-2.3|9.4|||Log Rank|||With PET||9.4|-2.3|0.17
74083701|NCT01332968|147720449|SUPERIORITY||Absolute difference in %|-5.5||||0.02|TWO_SIDED|95.0|-10.2|-0.78|||Log Rank|||Without PET||-0.78|-10.2|0.02
74083702|NCT01332968|147720449|SUPERIORITY||Absolute difference in %|5.2||||0.32|TWO_SIDED|95.0|-2.8|13.3|||Log Rank|||With PET||13.3|-2.8|0.32
74083703|NCT01332968|147720450|SUPERIORITY||Absolute difference in %|-4.9||||0.02||95.0|-9.3|0.6|||Log Rank|||Without PET||0.6|-9.3|0.02
74083704|NCT01332968|147720450|SUPERIORITY||Absolute difference in %|4.1||||0.33||95.0|-3.6|11.8|||Log Rank|||With PET||11.8|-3.6|0.33
74083705|NCT01332968|147720451|SUPERIORITY||Absolute difference in %|3.3||||0.052|TWO_SIDED|95.0|-0.19|6.85|||Log Rank|||Without PET||6.85|-0.19|0.052
74083706|NCT01332968|147720451|SUPERIORITY||Absolute difference in %|3.3||||0.3|TWO_SIDED|95.0|-2.3|8.9|||Log Rank|||With PET||8.9|-2.3|0.30
74083707|NCT01332968|147720452|SUPERIORITY||Absolute difference in %|3.2||||0.049|TWO_SIDED|95.0|-0.3|6.6|||Log Rank|||Without PET||6.6|-0.3|0.049
74083708|NCT01332968|147720452|SUPERIORITY||Absolute difference in %|3.9||||0.22|TWO_SIDED|95.0|-1.7|9.5|||Log Rank|||With PET||9.5|-1.7|0.22
74083709|NCT01332968|147720453|SUPERIORITY||Absolute difference in %|1.7||||0.58|TWO_SIDED|95.0|-3.5|6.8|||Log Rank|||Without PET||6.8|-3.5|0.58
74083710|NCT01332968|147720453|SUPERIORITY||Absolute difference in %|11.7||||0.006|TWO_SIDED|95.0|3.9|19.4|||Log Rank|||||19.4|3.9|0.006
74083711|NCT01332968|147720454|SUPERIORITY||Absolute difference in %|0.7||||0.8|TWO_SIDED|95.0|-4.0|5.5|||Log Rank|||Without PET||5.5|-4.0|0.80
74083712|NCT01332968|147720454|SUPERIORITY||Absolute difference in %|10.1||||0.009||95.0|2.6|17.6|||Log Rank|||With PET||17.6|2.6|0.009
74083713|NCT01332968|147720455|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3577||95.0|0.63|1.18|||Log Rank|||||1.18|0.63|0.3577
74083714|NCT01332968|147720456|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.25||95.0|0.58|1.16|||Log Rank|||||1.16|0.58|0.25
74083715|NCT01332968|147720457|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0015|TWO_SIDED|95.0|0.62|0.89|||Log Rank|||||0.89|0.62|0.0015
74083716|NCT01332968|147720458|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0004||95.0|0.56|0.85|||Log Rank|||||0.85|0.56|0.0004
74083717|NCT01332968|147720459|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.71|1.27|||Log Rank|||||1.27|0.71|
74083718|NCT01332968|147720460|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.5|1.19||||||||1.19|0.50|
74083719|NCT01332968|147720461|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.63|0.93|||Log Rank|||||0.93|0.63|
74083720|NCT01332968|147720462|SUPERIORITY||Hazard Ratio (HR)|0.69||||||95.0|0.55|0.88||||||||0.88|0.55|
74083721|NCT01332968|147720463|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.001|TWO_SIDED|95.0|0.58|0.87|||Log Rank|||||0.87|0.58|0.001
74083722|NCT01332968|147720464|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.004||95.0|0.54|0.89|||Log Rank|||||0.89|0.54|0.004
74083723|NCT03480022|147720473|SUPERIORITY||||||<|0.002|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.002
74083724|NCT03480022|147720474|SUPERIORITY||||||<|0.006|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.006
74083725|NCT03480022|147720475|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures nested design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.001
74083726|NCT03480022|147720476|SUPERIORITY||||||<|0.002|||||||ANOVA|one-way ANOVA||||||<0.002
74083727|NCT03480022|147720477|SUPERIORITY||||||<|0.007|||||||Wilcoxon (Mann-Whitney)|||||||<0.007
74083728|NCT03480022|147720478|SUPERIORITY||||||<|0.049|||||||Wilcoxon (Mann-Whitney)|||||||<0.049
74083729|NCT03480022|147720479|SUPERIORITY||||||<|0.011|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.011
74083730|NCT03480022|147720480|SUPERIORITY||||||<|0.038|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.038
74083731|NCT03480022|147720481|SUPERIORITY||||||<|0.048|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.048
74083732|NCT03480022|147720482|SUPERIORITY||||||<|0.018|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.018
73959302|NCT04673851|147454530|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|2.17|STANDARD_DEVIATION|7.84|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
73959303|NCT04673851|147454530|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.28|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
73959304|NCT04673851|147454530|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|6.48|STANDARD_DEVIATION|8.5|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
73959305|NCT04673851|147454530|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.76|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
73959306|NCT04673851|147454531|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|4.11|STANDARD_DEVIATION|6.86|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
74083733|NCT03480022|147720483|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
73836922|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
73836923|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
73836924|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.4||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.5|
73836925|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.6|
73836926|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.5|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-6.5|
74083734|NCT03480022|147720484|SUPERIORITY||||||<|0.034|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.034
73836927|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|1.8|||||TWO_SIDED|95.0|-1.7|9.6||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||9.6|-1.7|
73836928|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.2||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.2|-3.7|
73836929|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|-1.8|||||TWO_SIDED|95.0|-9.6|4.5||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||4.5|-9.6|
73959307|NCT04673851|147454531|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.6|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
73959308|NCT04673851|147454531|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|0.77|STANDARD_DEVIATION|6.88|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
73959309|NCT04673851|147454531|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.11|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
73959310|NCT04673851|147454531|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|-0.15|STANDARD_DEVIATION|5.78|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959311|NCT04673851|147454531|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.03|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959312|NCT04673851|147454531|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-2.63|STANDARD_DEVIATION|7.95|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959313|NCT04673851|147454531|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959314|NCT04673851|147454532|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|1.68|STANDARD_DEVIATION|3.76|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
73959315|NCT04673851|147454532|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.45|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
73959316|NCT04673851|147454532|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|-0.07|STANDARD_DEVIATION|2.73|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
73959317|NCT04673851|147454532|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.02|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
73959318|NCT04673851|147454532|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|-0.56|STANDARD_DEVIATION|2.44|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959319|NCT04673851|147454532|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.23|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959320|NCT04673851|147454532|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-0.59|STANDARD_DEVIATION|3.15|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959321|NCT04673851|147454532|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.19|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959322|NCT04673851|147454533|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|2.42|STANDARD_DEVIATION|4.48|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
73959323|NCT04673851|147454533|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.54|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
73959324|NCT04673851|147454533|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|0.83|STANDARD_DEVIATION|5.05|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
73836930|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|2.8|||||TWO_SIDED|95.0|-2.0|11.3||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||11.3|-2.0|
73959325|NCT04673851|147454533|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.17|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
73959326|NCT04673851|147454533|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|0.41|STANDARD_DEVIATION|4.55|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959327|NCT04673851|147454533|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.09|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959328|NCT04673851|147454533|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-2.04|STANDARD_DEVIATION|6.12|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959329|NCT04673851|147454533|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
73959330|NCT00922207|147454564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.6853|TWO_SIDED|95.0|0.46|1.75|||Cochran-Mantel-Haenszel|||||1.75|0.46|0.6853
73959331|NCT00922207|147454564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1977|TWO_SIDED|95.0|0.35|1.26|||Cochran-Mantel-Haenszel|||||1.26|0.35|0.1977
73959332|NCT00922207|147454564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.2916|TWO_SIDED|95.0|0.39|1.38|||Cochran-Mantel-Haenszel|||||1.38|0.39|0.2916
73959333|NCT00922207|147454565|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.34||||0.0353|TWO_SIDED|95.0|0.02|0.66|||ANCOVA|||Baseline||0.66|0.02|0.0353
73959334|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.1114|TWO_SIDED|95.0|-0.05|0.52|||ANCOVA|||Baseline||0.52|-0.05|0.1114
73959335|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.515|TWO_SIDED|95.0|-0.42|0.21|||ANCOVA|||Baseline||0.21|-0.42|0.5150
73959336|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|||<|0.001|TWO_SIDED|95.0|0.34|0.89|||ANCOVA|||Change at Week 4||0.89|0.34|<0.001
73959337|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.19|-1.65|||ANCOVA|||Change at Week 4||-1.65|-2.19|<0.001
73959338|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.54|||<|0.001|TWO_SIDED|95.0|-2.81|-2.27|||ANCOVA|||Change at Week 4||-2.27|-2.81|<0.001
73959339|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|||<|0.001|TWO_SIDED|95.0|1.34|2.06|||ANCOVA|||Change at Week 8||2.06|1.34|<0.001
73959340|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55||||0.0071|TWO_SIDED|95.0|-0.95|-0.15|||ANCOVA|||Change at Week 8||-0.15|-0.95|0.0071
73959341|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.26|||<|0.001|TWO_SIDED|95.0|-2.61|-1.9|||ANCOVA|||Change at Week 8||-1.90|-2.61|<0.001
73959342|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62|||<|0.001|TWO_SIDED|95.0|1.16|2.08|||ANCOVA|||Change at Week 16||2.08|1.16|<0.001
73959343|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.9557|TWO_SIDED|95.0|-0.56|0.53|||ANCOVA|||Change at Week 16||0.53|-0.56|0.9557
73959344|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.15|-1.14|||ANCOVA|||Change at Week 16||-1.14|-2.15|<0.001
73959345|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.0094|TWO_SIDED|95.0|0.18|1.27|||ANCOVA|||Change at Week 28||1.27|0.18|0.0094
73959346|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.0943|TWO_SIDED|95.0|-0.09|1.11|||ANCOVA|||Change at Week 28||1.11|-0.09|0.0943
73959347|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23||||0.4354|TWO_SIDED|95.0|-0.82|0.35|||ANCOVA|||Change at Week 28||0.35|-0.82|0.4354
73959348|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.2509|TWO_SIDED|95.0|-0.26|0.98|||ANCOVA|||Change at Week 40||0.98|-0.26|0.2509
73959349|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67||||0.0429|TWO_SIDED|95.0|0.02|1.31|||ANCOVA|||Change at Week 40||1.31|0.02|0.0429
73959350|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.3585|TWO_SIDED|95.0|-0.34|0.93|||ANCOVA|||Change at Week 40||0.93|-0.34|0.3585
73959351|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.9014|TWO_SIDED|95.0|-0.65|0.74|||ANCOVA|||Change at Week 52||0.74|-0.65|0.9014
73959352|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.1122|TWO_SIDED|95.0|-0.13|1.28|||ANCOVA|||Change at Week 52||1.28|-0.13|0.1122
73959353|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.1602|TWO_SIDED|95.0|-0.2|1.23|||ANCOVA|||Change at Week 52||1.23|-0.20|0.1602
73959354|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49||||0.1599|TWO_SIDED|95.0|-1.17|0.19|||ANCOVA|||Change at Week 64||0.19|-1.17|0.1599
73959355|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.5045|TWO_SIDED|95.0|-0.45|0.92|||ANCOVA|||Change at Week 64||0.92|-0.45|0.5045
73959356|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72||||0.0412|TWO_SIDED|95.0|0.03|1.41|||ANCOVA|||Change at Week 64||1.41|0.03|0.0412
73959357|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.1347|TWO_SIDED|95.0|-1.24|0.17|||ANCOVA|||Change at Week 76||0.17|-1.24|0.1347
73959358|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.4027|TWO_SIDED|95.0|-0.41|1.01|||ANCOVA|||Change at Week 76||1.01|-0.41|0.4027
73959359|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.0311|TWO_SIDED|95.0|0.07|1.55|||ANCOVA|||Change at Week 76||1.55|0.07|0.0311
73959360|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36||||0.3183|TWO_SIDED|95.0|-1.07|0.35|||ANCOVA|||Change at Week 88||0.35|-1.07|0.3183
73959361|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.1371|TWO_SIDED|95.0|-0.17|1.22|||ANCOVA|||Change at Week 88||1.22|-0.17|0.1371
73959362|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.0113|TWO_SIDED|95.0|0.21|1.6|||ANCOVA|||Change at Week 88||1.60|0.21|0.0113
73959363|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.5608|TWO_SIDED|95.0|-0.92|0.5|||ANCOVA|||Change at Week 100||0.50|-0.92|0.5608
73959364|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.6323|TWO_SIDED|95.0|-0.53|0.88|||ANCOVA|||Change at Week 100||0.88|-0.53|0.6323
73959365|NCT00922207|147454565|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.2752|TWO_SIDED|95.0|-0.32|1.11|||ANCOVA|||Change at Week 100||1.11|-0.32|0.2752
73959366|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.6107|TWO_SIDED|95.0|0.26|9.71|||Cochran-Mantel-Haenszel|||Baseline||9.71|0.26|0.6107
73959367|NCT00922207|147454566|SUPERIORITY_OR_OTHER|||||||0.0788|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.0788
73959368|NCT00922207|147454566|SUPERIORITY_OR_OTHER|||||||0.1761|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.1761
73959369|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.7044|TWO_SIDED|95.0|0.34|5.09|||Cochran-Mantel-Haenszel|||Week 4||5.09|0.34|0.7044
73959370|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.35||||0.0927|TWO_SIDED|95.0|0.61|46.76|||Cochran-Mantel-Haenszel|||Week 4||46.76|0.61|0.0927
73959371|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.04||||0.1858|TWO_SIDED|95.0|0.44|36.89|||Cochran-Mantel-Haenszel|||Week 4||36.89|0.44|0.1858
73959372|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9385|TWO_SIDED|95.0|0.33|3.38|||Cochran-Mantel-Haenszel|||Week 8||3.38|0.33|0.9385
73959373|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.5068|TWO_SIDED|95.0|0.43|5.77|||Cochran-Mantel-Haenszel|||Week 8||5.77|0.43|0.5068
73959374|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.5544|TWO_SIDED|95.0|0.41|5.5|||Cochran-Mantel-Haenszel|||Week 8||5.50|0.41|0.5544
73959375|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.651|TWO_SIDED|95.0|0.26|2.31|||Cochran-Mantel-Haenszel|||Week 16||2.31|0.26|0.6510
73959376|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.3192|TWO_SIDED|95.0|0.2|1.69|||Cochran-Mantel-Haenszel|||Week 16||1.69|0.20|0.3192
73959377|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.5818|TWO_SIDED|95.0|0.29|2.03|||Cochran-Mantel-Haenszel|||Week 16||2.03|0.29|0.5818
73959378|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8796|TWO_SIDED|95.0|0.41|2.66|||Cochran-Mantel-Haenszel|||Week 28||2.66|0.41|0.8796
73959379|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.305|TWO_SIDED|95.0|0.27|1.52|||Cochran-Mantel-Haenszel|||Week 28||1.52|0.27|0.3050
73959380|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.2414|TWO_SIDED|95.0|0.26|1.44|||Cochran-Mantel-Haenszel|||Week 28||1.44|0.26|0.2414
73959381|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8502|TWO_SIDED|95.0|0.5|2.22|||Cochran-Mantel-Haenszel|||Week 40||2.22|0.50|0.8502
73959382|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.5|TWO_SIDED|95.0|0.38|1.61|||Cochran-Mantel-Haenszel|||Week 40||1.61|0.38|0.5000
73959383|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.3882|TWO_SIDED|95.0|0.36|1.53|||Cochran-Mantel-Haenszel|||Week 40||1.53|0.36|0.3882
73959384|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9584|TWO_SIDED|95.0|0.5|1.99|||Cochran-Mantel-Haenszel|||Week 52||1.99|0.50|0.9584
73959385|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2576|TWO_SIDED|95.0|0.35|1.34|||Cochran-Mantel-Haenszel|||Week 52||1.34|0.35|0.2576
73959386|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2362|TWO_SIDED|95.0|0.36|1.34|||Cochran-Mantel-Haenszel|||Week 52||1.34|0.36|0.2362
73959387|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9861|TWO_SIDED|95.0|0.49|1.9|||Cochran-Mantel-Haenszel|||Week 64||1.90|0.49|0.9861
73959388|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.2919|TWO_SIDED|95.0|0.37|1.35|||Cochran-Mantel-Haenszel|||Week 64||1.35|0.37|0.2919
73959389|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.2674|TWO_SIDED|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 64||1.38|0.38|0.2674
73959390|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6148|TWO_SIDED|95.0|0.43|1.64|||Cochran-Mantel-Haenszel|||Week 76||1.64|0.43|0.6148
73959391|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57||||0.0904|TWO_SIDED|95.0|0.3|1.08|||Cochran-Mantel-Haenszel|||Week 76||1.08|0.30|0.0904
73959392|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.2073|TWO_SIDED|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 76||1.27|0.36|0.2073
73959393|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.998|TWO_SIDED|95.0|0.52|1.98|||Cochran-Mantel-Haenszel|||Week 88||1.98|0.52|0.9980
73959394|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.3489|TWO_SIDED|95.0|0.39|1.4|||Cochran-Mantel-Haenszel|||Week 88||1.40|0.39|0.3489
73836931|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-4.9|5.6||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||5.6|-4.9|
73959395|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.2847|TWO_SIDED|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 88||1.38|0.38|0.2847
73959396|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.5596|TWO_SIDED|95.0|0.44|1.62|||Cochran-Mantel-Haenszel|||Week 100||1.62|0.44|0.5596
73959397|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.2112|TWO_SIDED|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 100||1.27|0.36|0.2112
73959398|NCT00922207|147454566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4066|TWO_SIDED|95.0|0.43|1.48|||Cochran-Mantel-Haenszel|||Week 100||1.48|0.43|0.4066
73959399|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.6921|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.6921
73959400|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||0.3939|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.3939
73959401|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.6818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.6818
73959402|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.7582|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.7582
73959403|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.5381|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.5381
73959404|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.7747|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.7747
73959405|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.8034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.8034
73959406|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6306|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.6306
73959407|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.4574|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.4574
73959408|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5824|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.5824
73959409|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9321|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.9321
73959410|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.5263|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.5263
73959411|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.2025|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 22||||0.2025
73959412|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6702|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 22||||0.6702
73959413|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 22||||0.0818
73959414|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6214|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.6214
73959415|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6774|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.6774
73959416|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.3154|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.3154
73959417|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2709|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.2709
73959418|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.3804|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.3804
73959419|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7645|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.7645
73959420|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.182|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.1820
73959421|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.7167|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.7167
73959422|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.3104|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.3104
73959423|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.091|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.0910
73959424|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6094|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.6094
73959425|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.2166|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.2166
73959426|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.901|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.9010
73959427|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.906|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.9060
73959428|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.7268
73959429|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5372|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.5372
73959430|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.1588|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.1588
73959431|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.4268
73959432|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.4389|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.4389
73959433|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.6708|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.6708
73959434|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.2145|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.2145
73959435|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.8608|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.8608
73959436|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.0283|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.0283
74083735|NCT03480022|147720485|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.035
73959437|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.0369|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.0369
73959438|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4606|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.4606
73959439|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.0832|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.0832
73959440|NCT00922207|147454568|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.2655|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.2655
73959441|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.0649|TWO_SIDED|95.0|-0.01|0.43|||ANCOVA|||Baseline||0.43|-0.01|0.0649
73959442|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.1867|TWO_SIDED|95.0|-0.06|0.33|||ANCOVA|||Baseline||0.33|-0.06|0.1867
73959443|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.5003|TWO_SIDED|95.0|-0.3|0.15|||ANCOVA|||Baseline||0.15|-0.30|0.5003
73959444|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.2259|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||Change at Week 4||0.05|-0.22|0.2259
73959445|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Change at Week 4||-0.11|-0.36|<0.001
73959446|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.0085|TWO_SIDED|95.0|-0.27|-0.04|||ANCOVA|||Change at Week 4||-0.04|-0.27|0.0085
73959447|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.816|TWO_SIDED|95.0|-0.22|0.18|||ANCOVA|||Change at Week 8||0.18|-0.22|0.8160
73959448|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.4393|TWO_SIDED|95.0|-0.27|0.12|||ANCOVA|||Change at Week 8||0.12|-0.27|0.4393
73959449|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.489|TWO_SIDED|95.0|-0.22|0.11|||ANCOVA|||Change at Week 8||0.11|-0.22|0.4890
73959450|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.4656|TWO_SIDED|95.0|-0.14|0.3|||ANCOVA|||Change at Week 16||0.30|-0.14|0.4656
74083736|NCT03480022|147720486|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.0001
74083737|NCT03480022|147720487|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
73898387|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|2.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73959451|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.5016|TWO_SIDED|95.0|-0.15|0.31|||ANCOVA|||Change at Week 16||0.31|-0.15|0.5016
74083738|NCT03480022|147720488|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
74083739|NCT03480022|147720489|SUPERIORITY||||||<|0.021|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.021
74083740|NCT03480022|147720490|SUPERIORITY||||||<|0.009|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.009
74083741|NCT03480022|147720491|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.035
74083742|NCT03480022|147720492|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
74083743|NCT03480022|147720493|SUPERIORITY||||||<|0.042|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.042
74083744|NCT03480022|147720494|SUPERIORITY||||||<|0.033|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.033
74083745|NCT03480022|147720495|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
74083746|NCT03480022|147720496|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
74083747|NCT03480022|147720497|SUPERIORITY||||||<|0.016|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.016
74083748|NCT03480022|147720498|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
74083749|NCT03480022|147720499|SUPERIORITY||||||<|0.01|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.01
74083750|NCT03480022|147720500|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
74083751|NCT03480022|147720501|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
74083752|NCT03922750|147720504|OTHER||Estimated mean treatment difference|1.01||||0.7542|TWO_SIDED|95.0|-5.33|7.35|||ANCOVA|||The response and change from baseline in response during last two weeks of treatment (week 15 and 16) were analysed using an analysis of covariance (ANCOVA) model with treatment, pre-trial insulin treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values were imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset was analysed separately and estimates were combined using Rubin's rules.||7.35|-5.33|0.7542
74083753|NCT03922750|147720504|OTHER||Estimated mean treatment difference|7.88||||0.0107|TWO_SIDED|95.0|1.83|13.93|||ANCOVA|||The response and change from baseline in response during last two weeks of treatment (week 15 and 16) were analysed using an analysis of covariance (ANCOVA) model with treatment, pre-trial insulin treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values were imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset was analysed separately and estimates were combined using Rubin's rules.||13.93|1.83|0.0107
74083754|NCT05068661|147720548|SUPERIORITY||Risk Ratio (RR)|0.75||||0.486|TWO_SIDED|95.0|0.4|1.39|||Chi-squared|||||1.39|0.40|0.486
74083755|NCT05068661|147720549|SUPERIORITY||Risk Ratio (RR)|0.85||||0.148|TWO_SIDED|95.0|0.69|1.06||This is adjusted P value for hypotension|Chi-squared|||||1.06|0.69|0.148
74083756|NCT05068661|147720550|SUPERIORITY||Risk Ratio (RR)|1.04|||>|0.999|TWO_SIDED|95.0|0.98|1.1||This is adjusted P value|Chi-squared|||||1.10|0.98|>0.999
74083757|NCT05068661|147720551|SUPERIORITY||Mean Ratio|1.9||||0.128|TWO_SIDED|95.0|1.14|3.18||Adjusted P value|Regression, Linear|||||3.18|1.14|0.128
74083758|NCT05068661|147720552|SUPERIORITY||Mean Ratio|1.04|||>|0.999|TWO_SIDED|95.0|0.8|1.35||Adjusted P value|Regression, Linear|||||1.35|0.80|>0.999
74083759|NCT05068661|147720553|SUPERIORITY||Mean Ratio|0.97|||>|0.999|TWO_SIDED|95.0|0.93|1.3||Adjusted P value|Regression, Linear|||||1.30|0.93|>0.999
73836932|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|-3.6|||||TWO_SIDED|95.0|-12.5|3.2||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||3.2|-12.5|
73898388|NCT02880956|147328890|SUPERIORITY||LS Mean of Difference|0.17|STANDARD_ERROR_OF_MEAN|0.33||0.612|TWO_SIDED|95.0|-0.481|0.816||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.816|-0.481|0.612
73836933|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
73898389|NCT02880956|147328890|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|2.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73959452|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.9582|TWO_SIDED|95.0|-0.23|0.22|||ANCOVA|||Change at Week 16||0.22|-0.23|0.9582
73959453|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.6214|TWO_SIDED|95.0|-0.21|0.36|||ANCOVA|||Change at Week 28||0.36|-0.21|0.6214
73959454|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.5493|TWO_SIDED|95.0|-0.21|0.39|||ANCOVA|||Change at Week 28||0.39|-0.21|0.5493
73959455|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.8881|TWO_SIDED|95.0|-0.28|0.32|||ANCOVA|||Change at Week 28||0.32|-0.28|0.8881
73959456|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.7912|TWO_SIDED|95.0|-0.36|0.27|||ANCOVA|||Change at Week 40||0.27|-0.36|0.7912
73898390|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.405||0.52|TWO_SIDED|95.0|-1.058|0.535||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.535|-1.058|0.520
73959457|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.5427|TWO_SIDED|95.0|-0.24|0.46|||ANCOVA|||Change at Week 40||0.46|-0.24|0.5427
73959458|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.3788|TWO_SIDED|95.0|-0.19|0.49|||ANCOVA|||Change at Week 40||0.49|-0.19|0.3788
73959459|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.6172|TWO_SIDED|95.0|-0.44|0.26|||ANCOVA|||Change at Week 52||0.26|-0.44|0.6172
73959460|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.6002|TWO_SIDED|95.0|-0.29|0.5|||ANCOVA|||Change at Week 52||0.50|-0.29|0.6002
73959461|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.3101|TWO_SIDED|95.0|-0.18|0.56|||ANCOVA|||Change at Week 52||0.56|-0.18|0.3101
74083760|NCT05068661|147720554|SUPERIORITY||Risk Ratio (RR)|0.81|||>|0.999|TWO_SIDED|95.0|0.52|1.25||Adjusted P value|Chi-squared|||||1.25|0.52|>0.999
74083761|NCT05068661|147720555|SUPERIORITY||Risk Ratio (RR)|0.85|||>|0.999|TWO_SIDED|95.0|0.58|1.24||Adjusted P value|Chi-squared|||||1.24|0.58|>0.999
74083762|NCT05068661|147720556|SUPERIORITY||Mean Ratio|1.03|||>|0.999|TWO_SIDED|95.0|0.86|1.22||Adjusted P value|Regression, Linear|||||1.22|0.86|>0.999
74083763|NCT00550147|147720575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.125|STANDARD_ERROR_OF_MEAN|0.1933|<|0.05|TWO_SIDED|95.0|-1.52|-0.72|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-0.72|-1.52|<0.05
74083764|NCT00550147|147720576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.2056|<|0.05||95.0|-1.75|-0.91|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-0.91|-1.75|<0.05
74083765|NCT00550147|147720577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.3|STANDARD_ERROR_OF_MEAN|13.06|<|0.05||95.0|-74.3|-20.2|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-20.2|-74.3|<0.05
74088221|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.18||0.0002|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.30|-1.00|0.0002
73898391|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|3.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898392|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.401||0.303|TWO_SIDED|95.0|-1.201|0.374||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.374|-1.201|0.303
73898393|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898394|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.412||0.23|TWO_SIDED|95.0|-1.307|0.315||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.315|-1.307|0.230
73898395|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898396|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.5222||0.2|TWO_SIDED|95.0|-1.698|0.356||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.356|-1.698|0.200
73898397|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.07|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73836934|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
73836935|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.6|6.6||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.6|
73898398|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.508||0.873|TWO_SIDED|95.0|-1.08|0.917||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.917|-1.080|0.873
73898399|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73836936|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
73836937|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.6||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.5|
73898400|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.524||0.388|TWO_SIDED|95.0|-1.482|0.576||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.576|-1.482|0.388
73836938|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.5|6.7||||||Serotype 7F:Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-6.5|
73836939|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.7||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.6|
73836940|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
73836941|NCT01026038|147222739|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.8|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.8|
73836942|NCT01348490|147222750|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.025||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0250
73836943|NCT01348490|147222750|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.0163||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0163
73836944|NCT01348490|147222750|OTHER|1-sample t-test with null hypothesis mean \>= 0|||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
73836945|NCT01348490|147222750|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.2019||||||1-sample t-test was used.|t-test, 1 sided|||||||0.2019
73836946|NCT01348490|147222751|OTHER|||||||0.6887||||||1-sample t-test was used.|t-test, 1 sided|||||||0.6887
73836947|NCT01348490|147222751|OTHER||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
73836948|NCT01348490|147222751|OTHER|||||||0.8701||||||1-sample t-test was used.|t-test, 1 sided|||||||0.8701
73836949|NCT01348490|147222755|OTHER||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
73836950|NCT01348490|147222756|OTHER|||||||0.0028||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0028
73836951|NCT03632720|147222768|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95 percent (%) confidence interval (CI) was greater (\>) -10% for all four serogroups.|Difference in Percentage|0.64|||||TWO_SIDED|95.0|-1.78|3.54||||||Serogroup A||3.54|-1.78|
73836952|NCT03632720|147222768|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.24|2.28||||||Serogroup C||2.28|-2.24|
73836953|NCT03632720|147222768|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.33|2.36||||||Serogroup Y||2.36|-2.33|
73836954|NCT03632720|147222768|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|-0.58|||||TWO_SIDED|95.0|-3.22|1.81||||||Serogroup W||1.81|-3.22|
73836955|NCT03389750|147222816|EQUIVALENCE|An F-test was used to assess for significant differences among the 13 dose conditions.||||||0.0001|||||||ANOVA|F = 7.06 (DF=12)||||||.0001
73898401|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73836956|NCT01049828|147222817|OTHER|The analysis is based on a threshold-free cluster enhancement permutation technique.|||||<|0.01||||||all correlations were transformed into z scores using Fisher's transformation and a t test evaluated group differences.|Fisher Exact|The analysis is based on a threshold-free cluster enhancement permutation technique.||Null hypothesis: Fisher's transform z scores for a seed region were comparable between the control and non-bothered tinnitus groups.||||<0.01
73836957|NCT02186171|147222820|SUPERIORITY||LS Mean Difference|10.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|9.6|12.2||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||12.2|9.6|< 0.0001
73836958|NCT02186171|147222821|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.3|3.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||3.7|2.3|< 0.0001
73836959|NCT02186171|147222822|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|1.5|3.3||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||3.3|1.5|< 0.0001
73836960|NCT02186171|147222823|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|8.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|7.6|9.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||9.7|7.6|< 0.0001
73836961|NCT02186171|147222824|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|0.8|2.0||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||2.0|0.8|< 0.0001
73836962|NCT02186171|147222825|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.4|=|0.0033|TWO_SIDED|95.0|0.4|2.1||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||2.1|0.4|= 0.0033
73959462|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.4256|TWO_SIDED|95.0|-0.47|0.2|||ANCOVA|||Change at Week 64||0.20|-0.47|0.4256
73836963|NCT06868667|147222846|OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.11|1.52|||||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||1.52|0.11|
73836964|NCT05330429|147222880|SUPERIORITY||Hazard Ratio (HR)|0.956||||0.9323|TWO_SIDED|95.0|0.339|2.691|||Unstratified Log-rank Test|2-Sided P-value was based on unstratified log-rank test.|Hazard ratio and its 95% CI were calculated using unstratified Cox proportional hazards regression model.|||2.691|0.339|0.9323
73836965|NCT05330429|147222883|SUPERIORITY||Hazard Ratio (HR)|0.299|||||TWO_SIDED|95.0|0.056|1.6|||||Hazard ratio and its 95% CI were calculated using unstratified Cox proportional hazards regression model.|||1.600|0.056|
73836966|NCT03572218|147222890|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.22|TWO_SIDED||||||Mixed Models Analysis|||||||0.22
73836967|NCT03572218|147222891|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
73836968|NCT03572218|147222892|SUPERIORITY||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|1.9||0.03|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.03
73836969|NCT03572218|147222892|SUPERIORITY||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|1.1||0.02|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.02
73836970|NCT03572218|147222892|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|1.2||0.19|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.19
73836971|NCT03572218|147222893|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|2.1||0.11|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.11
73836972|NCT03572218|147222893|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.1||0.03|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.03
73836973|NCT03572218|147222893|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.3||0.53|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.53
73836974|NCT03572218|147222894|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
73836975|NCT03572218|147222895|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.09
73836976|NCT03572218|147222896|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|2.9||0.84|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score||||0.84
73836977|NCT03572218|147222896|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|4.0||0.82|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.82
73836978|NCT03572218|147222896|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|4.3||0.39|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.39
73836979|NCT03572218|147222896|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|5.0||0.42|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.42
73836980|NCT03572218|147222896|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|4.3||0.64|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.64
73836981|NCT03572218|147222896|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|3.6||0.59|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.59
73836982|NCT03572218|147222897|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|3.0||0.58|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score||||0.58
73836983|NCT03572218|147222897|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|4.0||0.89|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.89
73836984|NCT03572218|147222897|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|4.7||0.9|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.90
73836985|NCT03572218|147222897|SUPERIORITY||Mean Difference (Net)|-7.1|STANDARD_ERROR_OF_MEAN|5.0||0.16|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.16
73836986|NCT03572218|147222897|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|4.3||0.68|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.68
73836987|NCT03572218|147222897|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|3.6||0.72|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.72
73836988|NCT03572218|147222898|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.7||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||0.08
73836989|NCT03572218|147222899|SUPERIORITY||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|1.7||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||0.10
73836990|NCT03572218|147222900|SUPERIORITY||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.1||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
73836991|NCT03572218|147222901|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|1.1||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
73836992|NCT03572218|147222902|SUPERIORITY||Mean Difference (Net)|9.7|STANDARD_ERROR_OF_MEAN|6.5||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
73836993|NCT03572218|147222903|SUPERIORITY||Mean Difference (Net)|12.1|STANDARD_ERROR_OF_MEAN|6.5||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||0.06
73836994|NCT03572218|147222904|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|4.4||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
73836995|NCT03572218|147222905|SUPERIORITY||Mean Difference (Net)|3.1|STANDARD_ERROR_OF_MEAN|4.4||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
73836996|NCT03572218|147222906|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.4||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||0.31
73836997|NCT03572218|147222907|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.3||0.54|TWO_SIDED||||||Mixed Models Analysis|||||||0.54
73836998|NCT03572218|147222908|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.2||0.94|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.94
73836999|NCT03572218|147222908|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.6||0.64|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.64
73837000|NCT03572218|147222909|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.58|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.58
73837001|NCT03572218|147222909|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.49|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.49
73837002|NCT03572218|147222909|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.96|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.96
73837003|NCT03572218|147222909|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.71|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.71
73837004|NCT03572218|147222909|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.41|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.41
73837005|NCT03572218|147222910|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.61|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.61
73837006|NCT03572218|147222910|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.73|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.73
73837007|NCT03572218|147222910|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.94|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.94
73837008|NCT03572218|147222910|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.47|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.47
73837009|NCT03572218|147222910|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.99|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.99
73837010|NCT03572218|147222911|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
73837011|NCT03572218|147222912|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
73837012|NCT03572218|147222913|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
73837013|NCT03572218|147222914|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
73837014|NCT03572218|147222915|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.83|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.83
73837015|NCT03572218|147222915|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.69|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.69
73837016|NCT03572218|147222915|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.30
73837017|NCT03572218|147222915|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.99|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.99
73837018|NCT03572218|147222915|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.36|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.36
73837019|NCT03572218|147222916|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.30
73837020|NCT03572218|147222916|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.69|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.69
73837021|NCT03572218|147222916|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.70
73837022|NCT03572218|147222916|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.26|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.26
73837023|NCT03572218|147222916|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.18|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.18
73837024|NCT03572218|147222917|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.0||0.69|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.69
73837025|NCT03572218|147222917|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.28|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.28
73837026|NCT03572218|147222917|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.8||0.02|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.02
73837027|NCT03572218|147222918|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.29|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.29
73837028|NCT03572218|147222918|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.34|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.34
73837029|NCT03572218|147222918|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|0.8||0.001|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.001
73837030|NCT03572218|147222919|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.1||0.32|TWO_SIDED||||||Mixed Models Analysis|||||||0.32
73837031|NCT03572218|147222920|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.2||0.16|TWO_SIDED||||||Mixed Models Analysis|||||||0.16
73837032|NCT03572218|147222921|SUPERIORITY||Mean Difference (Net)|2.6|STANDARD_ERROR_OF_MEAN|4.8||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
73837033|NCT03572218|147222922|SUPERIORITY||Mean Difference (Net)|-10.2|STANDARD_ERROR_OF_MEAN|13.1||0.44|TWO_SIDED||||||Mixed Models Analysis|||||||0.44
73837034|NCT03572218|147222923|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.46|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.46
73837035|NCT03572218|147222923|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|0.4||0.12|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.12
73837036|NCT03572218|147222923|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.42|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.42
73837037|NCT03572218|147222923|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.4||0.03|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.03
73837038|NCT03572218|147222924|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.23|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.23
73837039|NCT03572218|147222924|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.9|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.90
73837040|NCT03572218|147222924|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.5||0.36|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.36
73837041|NCT03572218|147222924|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.4||0.29|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.29
73837042|NCT03572218|147222925|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.25|TWO_SIDED||||||Mixed Models Analysis|||||||0.25
73837043|NCT03572218|147222926|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|2.2||0.27|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.27
73837044|NCT03572218|147222926|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.13
73837045|NCT03572218|147222926|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|1.4||0.65|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.65
73837046|NCT03572218|147222927|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
73837047|NCT03572218|147222928|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.2||0.7|TWO_SIDED||||||Mixed Models Analysis|||||||0.7
73837048|NCT03572218|147222929|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|1.8||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.2
73837049|NCT03572218|147222930|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|6.9||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
73837050|NCT03572218|147222931|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|3.5||0.81|TWO_SIDED||||||Mixed Models Analysis|||Total||||0.81
73837051|NCT03572218|147222931|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|4.4||0.86|TWO_SIDED||||||Mixed Models Analysis|||Physical Function||||0.86
73837052|NCT03572218|147222931|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|7.0||0.87|TWO_SIDED||||||Mixed Models Analysis|||Self Esteem||||0.87
73837053|NCT03572218|147222931|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|5.2||0.73|TWO_SIDED||||||Mixed Models Analysis|||Sexual Life||||0.73
73837054|NCT03572218|147222931|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|4.4||0.95|TWO_SIDED||||||Mixed Models Analysis|||Work||||0.95
73837055|NCT03572218|147222931|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.8||0.19|TWO_SIDED||||||Mixed Models Analysis|||Public Distress||||0.19
73837056|NCT03572218|147222932|SUPERIORITY||Mean Difference (Net)|7.3|STANDARD_ERROR_OF_MEAN|4.9||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
73837057|NCT03572218|147222933|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.5||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
73837058|NCT03572218|147222934|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.5||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
73837059|NCT03572218|147222935|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|3.6||0.71|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.71
73837060|NCT03572218|147222935|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|1.9||0.72|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.72
73837061|NCT03572218|147222936|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
73837062|NCT03572218|147222937|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.52|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.52
73837063|NCT03572218|147222937|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.02|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.02
73837064|NCT03572218|147222937|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.63|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.63
73837065|NCT03572218|147222937|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.74|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.74
73837066|NCT03572218|147222937|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.49|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.49
73837067|NCT03572218|147222938|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
73837068|NCT03572218|147222939|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.2||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
73837069|NCT03572218|147222940|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.35|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.35
73837070|NCT03572218|147222940|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.46|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.46
73837071|NCT03572218|147222940|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.33|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.33
73837072|NCT03572218|147222940|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.18|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.18
73837073|NCT03572218|147222940|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.16|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.16
73837074|NCT03572218|147222941|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.3||0.82|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.82
73837075|NCT03572218|147222941|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.8||0.45|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.45
73837076|NCT03572218|147222941|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.007|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.007
73837077|NCT03572218|147222942|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.23|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.23
73837078|NCT03572218|147222942|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.48|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.48
73837079|NCT03572218|147222942|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.89|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.89
73837080|NCT03572218|147222942|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.3|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.30
73837081|NCT03572218|147222943|SUPERIORITY|||||||0.32|||||||ANOVA|||BWL component||||0.32
73837082|NCT03572218|147222944|SUPERIORITY|||||||0.14|||||||ANOVA|||||||0.14
73863132|NCT01345682|147272233|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|2.16||0.9773|TWO_SIDED|95.0|-4.3|4.18||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||4.18|-4.30|0.9773
73959463|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.9762|TWO_SIDED|95.0|-0.35|0.36|||ANCOVA|||Change at Week 64||0.36|-0.35|0.9762
73863133|NCT01345682|147272234|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.95||0.7767|TWO_SIDED|95.0|-3.28|4.39||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||4.39|-3.28|0.7767
73837083|NCT00286455|147222945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.76|-0.31||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.31|-0.76|<0.001
73837084|NCT00286455|147222945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.8|-0.35|||ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.35|-0.80|<0.001
73837085|NCT00286455|147222946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.14|-0.39|<0.001
73837086|NCT00286455|147222946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.46|-0.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.21|-0.46|<0.001
73837087|NCT00286455|147222947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.57|-0.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.23|-0.57|<0.001
73837088|NCT00286455|147222947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.68|<0.001
73837089|NCT00286455|147222948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|||<|0.001|TWO_SIDED|95.0|-0.63|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.25|-0.63|<0.001
73837090|NCT00286455|147222948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.73|-0.35||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.35|-0.73|<0.001
73837091|NCT00286455|147222949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.68|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.68|<0.001
73837092|NCT00286455|147222949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.74|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.74|<0.001
73837093|NCT00286455|147222950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||<|0.001|TWO_SIDED|95.0|-0.67|-0.24||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.67|<0.001
73837094|NCT00286455|147222950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.7|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.70|<0.001
73837095|NCT00286455|147222951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2||||0.002|TWO_SIDED|95.0|-21.5|-5.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.0|-21.5|0.002
73959464|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.4504|TWO_SIDED|95.0|-0.21|0.47|||ANCOVA|||Change at Week 64||0.47|-0.21|0.4504
73837096|NCT00286455|147222951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|||<|0.001|TWO_SIDED|95.0|-27.0|-10.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.4|-27.0|<0.001
73837097|NCT00286455|147222952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.4|||<|0.001|TWO_SIDED|95.0|-26.7|-10.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.1|-26.7|<0.001
73837098|NCT00286455|147222952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4|||<|0.001|TWO_SIDED|95.0|-29.7|-13.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.0|-29.7|<0.001
73837099|NCT00286455|147222953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.4|||<|0.001|TWO_SIDED|95.0|-27.1|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.7|-27.1|<0.001
73837100|NCT00286455|147222953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.4|||<|0.001|TWO_SIDED|95.0|-33.2|-15.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-15.7|-33.2|<0.001
73837101|NCT00286455|147222954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7||||0.001|TWO_SIDED|95.0|-26.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.7|-26.8|0.001
73837102|NCT00286455|147222954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.3|||<|0.001|TWO_SIDED|95.0|-32.4|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-32.4|<0.001
73837103|NCT00286455|147222955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.5||||0.002|TWO_SIDED|95.0|-26.8|-6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.2|-26.8|0.002
73837104|NCT00286455|147222955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|||<|0.001|TWO_SIDED|95.0|-31.6|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.8|-31.6|<0.001
73837105|NCT00286455|147222956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8|||<|0.001|TWO_SIDED|95.0|-30.9|-8.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.7|-30.9|<0.001
73837106|NCT00286455|147222956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4|||<|0.001|TWO_SIDED|95.0|-34.6|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-34.6|<0.001
73837107|NCT00286455|147222957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.001|TWO_SIDED|95.0|-30.6|-8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.0|-30.6|<0.001
73837108|NCT00286455|147222957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.3|||<|0.001|TWO_SIDED|95.0|-35.7|-12.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.9|-35.7|<0.001
73837109|NCT00286455|147222958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|||<|0.001|TWO_SIDED|95.0|-34.1|-9.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.0|-34.1|<0.001
73837110|NCT00286455|147222958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.8|||<|0.001|TWO_SIDED|95.0|-40.4|-15.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-15.1|-40.4|<0.001
73959465|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.4076|TWO_SIDED|95.0|-0.42|0.17|||ANCOVA|||Change at Week 76||0.17|-0.42|0.4076
73837111|NCT00286455|147222959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.569||||0.165|TWO_SIDED|95.0|0.257|1.262|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.262|0.257|0.165
73837112|NCT00286455|147222959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.008|TWO_SIDED|95.0|0.138|0.739|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.739|0.138|0.008
73837113|NCT00286455|147222960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.194||||0.001|TWO_SIDED|95.0|0.073|0.516|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.516|0.073|0.001
73837114|NCT00286455|147222960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.145|||<|0.001|TWO_SIDED|95.0|0.052|0.405|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.405|0.052|<0.001
73837115|NCT00286455|147222961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6||||0.056|TWO_SIDED|95.0|-15.3|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.2|-15.3|0.056
73837116|NCT00286455|147222961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3|||<|0.001|TWO_SIDED|95.0|-21.1|-5.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.5|-21.1|<0.001
73837117|NCT00286455|147222962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.85|TWO_SIDED|95.0|-7.8|9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.4|-7.8|0.850
73837118|NCT00286455|147222962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.571|TWO_SIDED|95.0|-6.2|11.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||11.2|-6.2|0.571
73837119|NCT00286455|147222963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.917|TWO_SIDED|95.0|-7.8|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.0|-7.8|0.917
73837120|NCT00286455|147222963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.133|TWO_SIDED|95.0|-13.2|1.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.7|-13.2|0.133
73837121|NCT00286455|147222964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.348|TWO_SIDED|95.0|-12.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.3|-12.1|0.348
73837122|NCT00286455|147222964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.152|TWO_SIDED|95.0|-14.3|2.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.2|-14.3|0.152
73837123|NCT00286455|147222965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2||||0.12|TWO_SIDED|95.0|-11.7|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.4|-11.7|0.120
73837124|NCT00286455|147222965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5||||0.104|TWO_SIDED|95.0|-12.1|1.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.1|-12.1|0.104
73837125|NCT00286455|147222966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.247|TWO_SIDED|95.0|-10.9|2.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.8|-10.9|0.247
73837126|NCT00286455|147222966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.129|TWO_SIDED|95.0|-12.3|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.6|-12.3|0.129
73959466|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.7591|TWO_SIDED|95.0|-0.37|0.27|||ANCOVA|||Change at Week 76||0.27|-0.37|0.7591
73837127|NCT00286455|147222967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.671|TWO_SIDED|95.0|-4.14|2.67||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.67|-4.14|0.671
73837128|NCT00286455|147222967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.218|TWO_SIDED|95.0|-5.57|1.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.27|-5.57|0.218
73837129|NCT00286455|147222968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54||||0.403|TWO_SIDED|95.0|-2.07|5.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.14|-2.07|0.403
73837130|NCT00286455|147222968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.487|TWO_SIDED|95.0|-2.35|4.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.93|-2.35|0.487
73837131|NCT00286455|147222969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.143|TWO_SIDED|95.0|-0.88|6.08||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.08|-0.88|0.143
73837132|NCT00286455|147222969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.974|TWO_SIDED|95.0|-3.46|3.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.57|-3.46|0.974
73837133|NCT00286455|147222970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97||||0.612|TWO_SIDED|95.0|-2.78|4.71||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.71|-2.78|0.612
73837134|NCT00286455|147222970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.587|TWO_SIDED|95.0|-4.82|2.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.74|-4.82|0.587
73837135|NCT00286455|147222971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.514|TWO_SIDED|95.0|-2.0|3.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.99|-2.00|0.514
73837136|NCT00286455|147222971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.899|TWO_SIDED|95.0|-2.83|3.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.22|-2.83|0.899
73837137|NCT00286455|147222972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.885|TWO_SIDED|95.0|-3.09|3.58||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.58|-3.09|0.885
73837138|NCT00286455|147222972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.958|TWO_SIDED|95.0|-3.28|3.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.46|-3.28|0.958
73837139|NCT00286455|147222973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.003|TWO_SIDED|95.0|-0.084|-0.018||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.018|-0.084|0.003
73837140|NCT00286455|147222973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.072|||<|0.001|TWO_SIDED|95.0|-0.105|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.038|-0.105|<0.001
73837141|NCT00286455|147222974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|||<|0.001|TWO_SIDED|95.0|-0.099|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.038|-0.099|<0.001
73863134|NCT01345682|147272235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.494|TWO_SIDED|95.0|0.717|1.99|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.990|0.717|0.494
73837142|NCT00286455|147222974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052||||0.001|TWO_SIDED|95.0|-0.083|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.021|-0.083|0.001
73837143|NCT00286455|147222975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|||<|0.001|TWO_SIDED|95.0|-0.103|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.032|-0.103|<0.001
73837144|NCT00286455|147222975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|||<|0.001|TWO_SIDED|95.0|-0.109|-0.037||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.037|-0.109|<0.001
73837145|NCT00286455|147222976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045||||0.021|TWO_SIDED|95.0|-0.084|-0.007||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.007|-0.084|0.021
73837146|NCT00286455|147222976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.043|TWO_SIDED|95.0|-0.079|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.001|-0.079|0.043
73837147|NCT00286455|147222977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.162|||<|0.001|TWO_SIDED|95.0|-0.255|-0.069||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.069|-0.255|<0.001
73837148|NCT00286455|147222977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159||||0.001|TWO_SIDED|95.0|-0.254|-0.065||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.065|-0.254|0.001
73837149|NCT00286455|147222978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.086||||0.001|TWO_SIDED|95.0|-0.138|-0.034||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.034|-0.138|0.001
73837150|NCT00286455|147222978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084||||0.002|TWO_SIDED|95.0|-0.137|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.032|-0.137|0.002
73837151|NCT00286455|147222979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.216||||0.23|TWO_SIDED|95.0|-0.568|0.137||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.137|-0.568|0.230
73837152|NCT00286455|147222979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.154||||0.393|TWO_SIDED|95.0|-0.508|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.200|-0.508|0.393
73837153|NCT00286455|147222980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084||||0.703|TWO_SIDED|95.0|-0.348|0.515||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.515|-0.348|0.703
73837154|NCT00286455|147222980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.203|TWO_SIDED|95.0|-0.153|0.717||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.717|-0.153|0.203
73837155|NCT00286455|147222981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169||||0.408|TWO_SIDED|95.0|-0.232|0.569||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.569|-0.232|0.408
73837156|NCT00286455|147222981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013||||0.949|TWO_SIDED|95.0|-0.391|0.417||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.417|-0.391|0.949
73863135|NCT01345682|147272236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.584|TWO_SIDED|95.0|0.687|1.95|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.950|0.687|0.584
73837157|NCT00286455|147222982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.886|TWO_SIDED|95.0|-0.44|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.380|-0.440|0.886
73837158|NCT00286455|147222982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.645|TWO_SIDED|95.0|-0.51|0.317||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.317|-0.510|0.645
73837159|NCT00286455|147222983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.656|TWO_SIDED|95.0|-0.378|0.239||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.239|-0.378|0.656
73959467|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.6449|TWO_SIDED|95.0|-0.25|0.4|||ANCOVA|||Change at Week 76||0.40|-0.25|0.6449
73959468|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.7108|TWO_SIDED|95.0|-0.36|0.25|||ANCOVA|||Change at Week 88||0.25|-0.36|0.7108
73959469|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.4725|TWO_SIDED|95.0|-0.22|0.47|||ANCOVA|||Change at Week 88||0.47|-0.22|0.4725
73959470|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.2439|TWO_SIDED|95.0|-0.13|0.5|||ANCOVA|||Change at Week 88||0.50|-0.13|0.2439
73959471|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.1862|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||Change at Week 100||0.50|-0.10|0.1862
73837160|NCT00286455|147222983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036||||0.819|TWO_SIDED|95.0|-0.347|0.275||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.275|-0.347|0.819
73863136|NCT01345682|147272237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.816|TWO_SIDED|95.0|0.657|1.705|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.705|0.657|0.816
73837161|NCT00286455|147222984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079||||0.642|TWO_SIDED|95.0|-0.411|0.253||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.253|-0.411|0.642
74022078|NCT03093402|147596787|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 85.||||0.780
73959472|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.3057|TWO_SIDED|95.0|-0.14|0.43|||ANCOVA|||Change at Week 100||0.43|-0.14|0.3057
73837162|NCT00286455|147222984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.986|TWO_SIDED|95.0|-0.332|0.338||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.338|-0.332|0.986
73837163|NCT00286455|147222985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.686||||0.305|TWO_SIDED|95.0|0.622|4.571|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.571|0.622|0.305
73837164|NCT00286455|147222985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.349||||0.091|TWO_SIDED|95.0|0.873|6.321|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.321|0.873|0.091
73837165|NCT00286455|147222986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.704||||0.001|TWO_SIDED|95.0|1.694|8.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||8.100|1.694|0.001
73837166|NCT00286455|147222986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.305||||0.003|TWO_SIDED|95.0|1.505|7.255|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.255|1.505|0.003
73837167|NCT00286455|147222987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.905||||0.006|TWO_SIDED|95.0|1.359|6.21|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.210|1.359|0.006
73837168|NCT00286455|147222987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.552|||<|0.001|TWO_SIDED|95.0|2.068|10.017|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||10.017|2.068|<0.001
73837169|NCT00286455|147222988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.663||||0.004|TWO_SIDED|95.0|1.367|5.188|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.188|1.367|0.004
73837170|NCT00286455|147222988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.277|||<|0.001|TWO_SIDED|95.0|1.671|6.429|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.429|1.671|<0.001
73837171|NCT00286455|147222989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.331||||0.002|TWO_SIDED|95.0|1.714|10.947|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||10.947|1.714|0.002
73837172|NCT00286455|147222989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.732||||0.001|TWO_SIDED|95.0|1.862|12.025|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||12.025|1.862|0.001
73837173|NCT00286455|147222990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.766||||0.153|TWO_SIDED|95.0|0.685|11.16|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.160|0.685|0.153
73837174|NCT00286455|147222990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.632||||0.029|TWO_SIDED|95.0|1.169|18.354|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||18.354|1.169|0.029
73837175|NCT00286455|147222991|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.102
73837176|NCT00286455|147222991|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.063
73837177|NCT00286455|147222992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.186|TWO_SIDED|95.0|-0.18|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.93|-0.18|0.186
73837178|NCT00286455|147222992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.237|TWO_SIDED|95.0|-0.22|0.89||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.89|-0.22|0.237
73837179|NCT00286455|147222993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.702|TWO_SIDED|95.0|-0.74|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.50|-0.74|0.702
73837180|NCT00286455|147222993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.338|TWO_SIDED|95.0|-0.32|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.93|-0.32|0.338
73837181|NCT00286455|147222994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.978|TWO_SIDED|95.0|-0.74|0.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.72|-0.74|0.978
73837182|NCT00286455|147222994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.73|0.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.74|-0.73|0.991
73959473|NCT00922207|147454569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.8002|TWO_SIDED|95.0|-0.38|0.29|||ANCOVA|||Change at Week 100||0.29|-0.38|0.8002
74022079|NCT03093402|147596787|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 113.||||0.285
73959474|NCT02326649|147454571|OTHER|||||||0.47|||||||paired t-test|||||||0.47
73837183|NCT00286455|147222995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.539|TWO_SIDED|95.0|-1.16|0.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.61|-1.16|0.539
73837184|NCT00286455|147222995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.379|TWO_SIDED|95.0|-1.29|0.49||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.49|-1.29|0.379
73837185|NCT00286455|147222996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.616|TWO_SIDED|95.0|-4.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.5|-4.4|0.616
73837186|NCT00286455|147222996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.93|TWO_SIDED|95.0|-6.4|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.4|0.930
73837187|NCT00286455|147222997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.915|TWO_SIDED|95.0|-5.3|6.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.0|-5.3|0.915
73837188|NCT00286455|147222997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.745|TWO_SIDED|95.0|-4.8|6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.7|-4.8|0.745
73837189|NCT00286455|147222998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.466|TWO_SIDED|95.0|-3.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.5|-3.4|0.466
73837190|NCT00286455|147222998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.154|TWO_SIDED|95.0|-1.5|9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.6|-1.5|0.154
73837191|NCT00286455|147222999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.774|TWO_SIDED|95.0|-5.1|6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.9|-5.1|0.774
73837192|NCT00286455|147222999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.761|TWO_SIDED|95.0|-5.2|7.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.1|-5.2|0.761
73837193|NCT00286455|147223000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.559|TWO_SIDED|95.0|-4.2|7.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.7|-4.2|0.559
73837194|NCT00286455|147223000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.523|TWO_SIDED|95.0|-4.1|8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||8.0|-4.1|0.523
73837195|NCT00286455|147223001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.739|TWO_SIDED|95.0|-7.4|5.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.2|-7.4|0.739
73837196|NCT00286455|147223001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.388|TWO_SIDED|95.0|-9.3|3.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.6|-9.3|0.388
73837197|NCT06097273|147223002|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.155|||||TWO_SIDED|97.5|1.086|1.229||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||1.229|1.086|
73837198|NCT06097273|147223002|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>1.|GMR|1.155|||||TWO_SIDED|95.0|1.094|1.22||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||1.220|1.094|
73837199|NCT06097273|147223002|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.063|||||TWO_SIDED|97.5|0.999|1.13||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||1.130|0.999|
73837200|NCT06097273|147223002|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.063|||||TWO_SIDED|95.0|1.007|1.122||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||1.122|1.007|
73837201|NCT06097273|147223002|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.414|||||TWO_SIDED|97.5|1.322|1.513||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||1.513|1.322|
73837202|NCT06097273|147223002|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.414|||||TWO_SIDED|95.0|1.333|1.5||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||1.500|1.333|
73837203|NCT06097273|147223002|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.38|||||TWO_SIDED|97.5|1.3|1.465||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||1.465|1.300|
73837204|NCT06097273|147223002|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.38|||||TWO_SIDED|95.0|1.31|1.454||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||1.454|1.310|
73837205|NCT06097273|147223002|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.118|||||TWO_SIDED|97.5|1.063|1.175||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Victoria-lineage Antibody||1.175|1.063|
73837206|NCT06097273|147223002|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.118|||||TWO_SIDED|95.0|1.07|1.167||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Victoria-lineage Antibody||1.167|1.070|
73837207|NCT06097273|147223002|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.007|||||TWO_SIDED|97.5|0.969|1.047||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Yamagata-lineage Antibody||1.047|0.969|
73837208|NCT06097273|147223002|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.007|||||TWO_SIDED|95.0|0.973|1.042||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Yamagata-lineage Antibody||1.042|0.973|
73837209|NCT06097273|147223002|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.216|||||TWO_SIDED|97.5|1.156|1.278||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Victoria-lineage Antibody||1.278|1.156|
73837210|NCT06097273|147223002|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.216|||||TWO_SIDED|95.0|1.163|1.27||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Victoria-lineage Antibody||1.270|1.163|
73837211|NCT06097273|147223002|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.154|||||TWO_SIDED|97.5|1.109|1.201||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Yamagata-lineage Antibody||1.201|1.109|
73837212|NCT06097273|147223002|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.154|||||TWO_SIDED|95.0|1.115|1.195||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Yamagata-lineage Antibody||1.195|1.115|
73837213|NCT06097273|147223003|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.641|||||TWO_SIDED|95.0|1.526|1.765||||||GMR (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||1.765|1.526|
73837214|NCT06097273|147223003|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.641|||||TWO_SIDED|97.5|1.51|1.783||||||GMR (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||1.783|1.510|
73837215|NCT06097273|147223003|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.308|||||TWO_SIDED|95.0|1.219|1.404||||||GMR (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||1.404|1.219|
73837216|NCT06097273|147223003|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.308|||||TWO_SIDED|97.5|1.207|1.418||||||GMR (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||1.418|1.207|
73837217|NCT06097273|147223004|SUPERIORITY|The superiority in seroconversion rate (SCR) in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|5.4|||||TWO_SIDED|95.0|2.4|8.4||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||8.4|2.4|
73837218|NCT06097273|147223004|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|5.4|||||TWO_SIDED|97.5|1.9|8.8||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||8.8|1.9|
73837219|NCT06097273|147223004|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|4.0|||||TWO_SIDED|95.0|1.0|7.1||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||7.1|1.0|
73837220|NCT06097273|147223004|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|4.0|||||TWO_SIDED|97.5|0.5|7.6||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||7.6|0.5|
73837221|NCT06097273|147223004|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|4.5|||||TWO_SIDED|95.0|1.9|7.2||||||Percentage Difference (Cohort A1 vs Cohort A2) for Victoria-lineage Antibody||7.2|1.9|
73837222|NCT06097273|147223004|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|4.5|||||TWO_SIDED|95.0|1.5|7.5||||||Percentage Difference (Cohort A1 vs Cohort A2) for Victoria-lineage Antibody||7.5|1.5|
73837223|NCT06097273|147223004|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-3.3|0.4||||||Percentage Difference (Cohort A1 vs Cohort A2) for Yamagata-lineage Antibody||0.4|-3.3|
73837224|NCT06097273|147223004|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|-1.4|||||TWO_SIDED|97.5|-3.6|0.7||||||Percentage Difference (Cohort A1 vs Cohort A2) for Yamagata-lineage Antibody||0.7|-3.6|
73837225|NCT06097273|147223004|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|17.9|||||TWO_SIDED|95.0|14.8|21.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||21.0|14.8|
73837226|NCT06097273|147223004|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|17.9|||||TWO_SIDED|97.5|14.3|21.4||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||21.4|14.3|
73837227|NCT06097273|147223004|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|14.6|||||TWO_SIDED|95.0|11.6|17.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||17.6|11.6|
73837228|NCT06097273|147223004|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|14.6|||||TWO_SIDED|97.5|11.1|18.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||18.0|11.1|
73837229|NCT06097273|147223004|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|8.6|||||TWO_SIDED|95.0|6.0|11.2||||||Percentage Difference (Cohort B1 vs Cohort B2) for Victoria-lineage Antibody||11.2|6.0|
73837230|NCT06097273|147223004|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|8.6|||||TWO_SIDED|97.5|5.6|11.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for Victoria-lineage Antibody||11.6|5.6|
73837231|NCT06097273|147223004|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|2.7|||||TWO_SIDED|95.0|0.6|4.7||||||Percentage Difference (Cohort B1 vs Cohort B2) for Yamagata-lineage Antibody||4.7|0.6|
73837232|NCT06097273|147223004|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|2.7|||||TWO_SIDED|97.5|0.3|5.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Yamagata-lineage Antibody||5.0|0.3|
73959475|NCT02326649|147454571|OTHER||Mean Difference (Final Values)|6.561|STANDARD_ERROR_OF_MEAN|5.528||0.255|TWO_SIDED|95.0|-5.295|18.417|||Regression, Linear|||Intercept for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||18.417|-5.295|0.255
73837233|NCT06097273|147223005|SUPERIORITY|The superiority in seroresponse rate (SRR) in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SRR difference was \>0%.|Percentage Difference|12.8|||||TWO_SIDED|95.0|10.0|15.5||||||Percentage Difference (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||15.5|10.0|
73837234|NCT06097273|147223005|NON_INFERIORITY|The noninferiority in SRR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SRR difference was \>-10%.|Percentage Difference|12.8|||||TWO_SIDED|97.5|9.6|15.9||||||Percentage Difference (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||15.9|9.6|
73837235|NCT06097273|147223005|SUPERIORITY|The superiority in SRR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SRR difference was \>0%.|Percentage Difference|8.1|||||TWO_SIDED|95.0|5.5|10.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||10.6|5.5|
73837236|NCT06097273|147223005|NON_INFERIORITY|The noninferiority in SRR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SRR difference was \>-10%.|Percentage Difference|8.1|||||TWO_SIDED|97.5|5.2|11.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||11.0|5.2|
73837237|NCT03931785|147223039|SUPERIORITY||Least squares (LS) mean difference|0.08||||0.7467|TWO_SIDED|95.0|-0.42|0.58|||MMRM||MD-7246 minus placebo|||0.58|-0.42|0.7467
73837238|NCT03931785|147223039|SUPERIORITY||LS mean difference|0.43||||0.0941|TWO_SIDED|95.0|-0.07|0.93|||MMRM||MD-7246 minus placebo|||0.93|-0.07|0.0941
73837239|NCT03931785|147223039|SUPERIORITY||LS mean difference|0.06||||0.8098|TWO_SIDED|95.0|-0.44|0.56|||MMRM||MD-7246 minus placebo|||0.56|-0.44|0.8098
73837240|NCT03931785|147223040|SUPERIORITY||Difference in Responder Rate|1.0|||||TWO_SIDED|95.0|-12.9|15.0|||||Difference in responder rate (MD-7246 - placebo). 95% confidence intervals (CIs) for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||15.0|-12.9|
73837241|NCT03931785|147223040|SUPERIORITY||Difference in Responder Rate|-11.3|||||TWO_SIDED|95.0|-25.3|2.6|||||Difference in responder rate (MD-7246 - placebo). 95% CIs for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||2.6|-25.3|
73959476|NCT02326649|147454571|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.417||0.25|TWO_SIDED|95.0|-0.395|1.395|||Regression, Linear|||Heart rate delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||1.395|-0.395|0.250
73837242|NCT03931785|147223040|SUPERIORITY||Difference in Responder Rate|-7.2|||||TWO_SIDED|95.0|-21.2|6.8|||||Difference in responder rate (MD-7246 - placebo). 95% CIs for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||6.8|-21.2|
73837243|NCT03931785|147223040|SUPERIORITY||Odds Ratio (OR)|1.043||||0.8852|TWO_SIDED|95.0|0.591|1.839|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.839|0.591|0.8852
73837244|NCT03931785|147223040|SUPERIORITY||Odds Ratio (OR)|0.634||||0.1152|TWO_SIDED|95.0|0.36|1.117|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.117|0.360|0.1152
73837245|NCT03931785|147223040|SUPERIORITY||Odds Ratio (OR)|0.749||||0.3157|TWO_SIDED|95.0|0.425|1.317|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.317|0.425|0.3157
73863137|NCT01345682|147272238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0217|TWO_SIDED|95.0|0.55|0.96||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|||0.96|0.55|0.0217
73837246|NCT02504775|147223043|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|94.704|||||TWO_SIDED|90.0|88.329|101.54|||ANOVA|||||101.540|88.329|
73837247|NCT02504775|147223044|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|95.989|||||TWO_SIDED|90.0|89.826|102.574|||ANOVA|||||102.574|89.826|
73837248|NCT02504775|147223045|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|106.132|||||TWO_SIDED|90.0|85.151|132.283|||ANOVA|||||132.283|85.151|
73837249|NCT01230814|147223048|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.69|TWO_SIDED|95.0|0.62|1.37||The a priori threshold for statistical significance for VVC was p\<0.020 (two-sided).|Clustered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk \<1 indicates a lower percentage of positive test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which VVC was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).||1.37|0.62|0.690
73837250|NCT01230814|147223049|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65||||0.005|TWO_SIDED|95.0|0.48|0.87||The a priori threshold for statistical significance for BV was p\<0.030 (two-sided).|clutstered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk \<1 indicates a lower percentage of test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which BV was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).||0.87|0.48|0.005
73837251|NCT01260324|147223071|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.01|||||TWO_SIDED|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 18 to 34||0.01|0.01|
73837252|NCT01260324|147223071|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.01|||||TWO_SIDED|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 35 to 44||0.01|0.01|
73837253|NCT01260324|147223071|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.03|||||TWO_SIDED|95.0|0.03|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 45 to 54||0.04|0.03|
73837254|NCT01260324|147223071|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.08|||||TWO_SIDED|95.0|0.07|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 55 to 64||0.09|0.07|
73837255|NCT01260324|147223071|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.12|||||TWO_SIDED|95.0|0.11|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 65 to 74||0.14|0.11|
73837256|NCT01260324|147223071|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.18|||||TWO_SIDED|95.0|0.15|0.21|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age ≥75||0.21|0.15|
73837257|NCT01260324|147223071|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.09|||||TWO_SIDED|95.0|0.06|0.13|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 18 to 34||0.13|0.06|
73837258|NCT01260324|147223071|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.11|||||TWO_SIDED|95.0|0.08|0.16|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 35 to 44||0.16|0.08|
73837259|NCT01260324|147223071|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.37|||||TWO_SIDED|95.0|0.3|0.45|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 45 to 54||0.45|0.30|
73837260|NCT01260324|147223071|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.83|||||TWO_SIDED|95.0|2.68|5.47|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 65 to 74||5.47|2.68|
73837261|NCT01260324|147223071|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.73|||||TWO_SIDED|95.0|4.0|8.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age ≥75||8.22|4.00|
73837262|NCT01260324|147223072|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Female||0.05|0.04|
73837263|NCT01260324|147223072|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Male||0.06|0.05|
73837264|NCT01260324|147223072|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83|||||TWO_SIDED|95.0|1.5|2.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Male||2.22|1.50|
73837265|NCT01260324|147223073|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2003||0.05|0.04|
73837266|NCT01260324|147223073|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2004||0.05|0.04|
73837267|NCT01260324|147223073|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2005||0.05|0.04|
73837268|NCT01260324|147223073|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2006||0.05|0.04|
73837269|NCT01260324|147223073|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2007||0.05|0.04|
73837270|NCT01260324|147223073|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2004||0.96|0.61|
73837271|NCT01260324|147223073|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.58|0.91|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2005||0.91|0.58|
73837272|NCT01260324|147223073|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.68|1.12|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2006||1.12|0.68|
73837273|NCT01260324|147223073|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.19|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2007||1.19|0.72|
73837274|NCT01260324|147223074|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Northeast||0.06|0.04|
73837275|NCT01260324|147223074|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Midwest||0.05|0.04|
73837276|NCT01260324|147223074|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate South||0.06|0.05|
73837277|NCT01260324|147223074|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate West||0.05|0.04|
73837278|NCT01260324|147223074|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.31|0.56|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Northeast||0.56|0.31|
73837279|NCT01260324|147223074|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.68|||||TWO_SIDED|95.0|0.56|0.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Midwest||0.84|0.56|
73837280|NCT01260324|147223074|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.57|0.93|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio West||0.93|0.57|
73837281|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.09|||||TWO_SIDED|95.0|0.08|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diabetes||0.10|0.08|
73837282|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.11|||||TWO_SIDED|95.0|0.08|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Smoking||0.14|0.08|
73837283|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.03|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Obesity||0.06|0.03|
73837284|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.07|||||TWO_SIDED|95.0|0.06|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Nitrates||0.09|0.06|
73837285|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.15|||||TWO_SIDED|95.0|0.12|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Anti-platelet agents||0.18|0.12|
73837286|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.13|||||TWO_SIDED|95.0|0.09|0.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diuretics||0.17|0.09|
73837287|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.03|||||TWO_SIDED|95.0|0.01|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent PDE-5 inhibitors use||0.04|0.01|
73837288|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.82|||||TWO_SIDED|95.0|1.47|2.25|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diabetes||2.25|1.47|
73837289|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.63|2.85|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Smoking||2.85|0.63|
73837290|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.43|||||TWO_SIDED|95.0|0.23|0.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Obesity||0.81|0.23|
73837291|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.42|0.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Nitrates||0.94|0.42|
73837292|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|1.53|2.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Anti-platelet agents||2.94|1.53|
73837293|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24|||||TWO_SIDED|95.0|1.46|3.43|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diuretics||3.43|1.46|
73837294|NCT01260324|147223075|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.57|||||TWO_SIDED|95.0|0.31|1.04|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Recent PDE-5 inhibitors use||1.04|0.31|
73837295|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.33|||||TWO_SIDED|95.0|0.28|0.39|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other retinal disorders||0.39|0.28|
73837296|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.13|||||TWO_SIDED|95.0|0.11|0.16|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Glaucoma||0.16|0.11|
73837297|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.2|||||TWO_SIDED|95.0|0.08|0.41|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Cataract||0.41|0.08|
73837298|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.99|||||TWO_SIDED|95.0|0.83|1.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Visual disturbances||1.17|0.83|
73837299|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|2.0|||||TWO_SIDED|95.0|1.6|2.46|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Blindness and low vision||2.46|1.60|
73837300|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.19|||||TWO_SIDED|95.0|0.16|0.23|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of eye||0.23|0.16|
73837301|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.22|||||TWO_SIDED|95.0|0.18|0.27|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Occlusion and stenosis of precerebral arteries||0.27|0.18|
73837302|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.07|||||TWO_SIDED|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Acute sinusitis||0.08|0.05|
73837303|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other dermatoses||0.08|0.05|
73837304|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.08|||||TWO_SIDED|95.0|0.06|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of bone and cartilage||0.10|0.06|
73837305|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.12|||||TWO_SIDED|95.0|0.1|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Symptoms involving head and neck||0.14|0.10|
73837306|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.14|||||TWO_SIDED|95.0|0.1|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other ill defined and unknown causes of morbidity and mortality||0.18|0.10|
73837307|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.65|||||TWO_SIDED|95.0|4.72|9.38|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other retinal disorders||9.38|4.72|
73837308|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.77|3.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Glaucoma||3.81|1.77|
73837309|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|1.02|1.68|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Cataract||1.68|1.02|
73837310|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|14.2|||||TWO_SIDED|95.0|10.4|19.3|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Visual disturbances||19.30|10.40|
73837311|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.1|||||TWO_SIDED|95.0|6.6|34.5|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Blindness and low vision||34.50|6.60|
73837312|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02|||||TWO_SIDED|95.0|1.44|2.82|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of eye||2.82|1.44|
73837313|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.64|2.31|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Occlusion and stenosis of precerebral arteries||2.31|0.64|
73837314|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.96|1.74|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Acute sinusitis||1.74|0.96|
73837315|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|1.02|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other dermatoses||1.77|1.02|
73837316|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.98|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of bone and cartilage||1.77|0.98|
73837317|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.02|1.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Symptoms involving head and neck||1.84|1.02|
73837318|NCT01260324|147223076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.08|2.49|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Ill defined and unknown causes of morbidity and mortality||2.49|1.08|
73837319|NCT01260324|147223077|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.03|0.07|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent use||0.07|0.03|
73837320|NCT01260324|147223077|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.04|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Any use (includes chronic and non-chronic use)||0.08|0.04|
73837321|NCT01260324|147223077|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.03|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Chronic use||0.08|0.03|
73837322|NCT01260324|147223077|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.03|0.11|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Non-chronic use||0.11|0.03|
73837323|NCT01260324|147223077|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.09|||||TWO_SIDED|95.0|0.08|0.1|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Never use||0.10|0.08|
73837324|NCT02596893|147223081|SUPERIORITY||Stratified Difference|-2.9||||0.2523|TWO_SIDED|95.0|-9.7|3.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||3.9|-9.7|0.2523
73837325|NCT02596893|147223081|SUPERIORITY||Slope|4.8||||0.1626|TWO_SIDED|95.0|-3.0|11.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||11.8|-3.0|0.1626
73837326|NCT02596893|147223081|SUPERIORITY||Stratified Difference|-2.1||||0.442|TWO_SIDED|95.0|-9.1|5.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.3|-9.1|0.4420
73837327|NCT02596893|147223082|SUPERIORITY||Stratified Difference|-2.6||||0.1799|TWO_SIDED|95.0|-9.5|5.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.0|-9.5|0.1799
73837328|NCT02596893|147223082|SUPERIORITY||Stratified Difference|-2.4||||0.2309|TWO_SIDED|95.0|-9.4|4.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||4.9|-9.4|0.2309
73837329|NCT02596893|147223082|SUPERIORITY||Stratified Difference|-2.1||||0.3264|TWO_SIDED|95.0|-9.1|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||4.6|-9.1|0.3264
73837330|NCT02596893|147223083|SUPERIORITY||Stratified Difference|-11.7||||0.0299|TWO_SIDED|95.0|-22.0|-1.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||-1.1|-22.0|0.0299
73837331|NCT02596893|147223083|SUPERIORITY||Stratified difference|-9.9||||0.0582|TWO_SIDED|95.0|-20.3|0.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||0.7|-20.3|0.0582
73837332|NCT02596893|147223083|SUPERIORITY||Stratified difference|-9.7||||0.0741|TWO_SIDED|95.0|-20.1|1.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||1.0|-20.1|0.0741
73837333|NCT02596893|147223084|SUPERIORITY||Stratified difference|-5.8||||0.2493|TWO_SIDED|95.0|-15.5|4.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.0|-15.5|0.2493
73837334|NCT02596893|147223084|SUPERIORITY||Stratified difference|-1.8||||0.716|TWO_SIDED|95.0|-11.8|8.2|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||8.2|-11.8|0.7160
73837335|NCT02596893|147223084|SUPERIORITY||Stratified difference|-5.8||||0.2452|TWO_SIDED|95.0|-15.5|4.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.1|-15.5|0.2452
73837336|NCT02596893|147223085|SUPERIORITY||Stratified difference|-1.3||||0.7541|TWO_SIDED|95.0|-9.8|7.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||7.1|-9.8|0.7541
73837337|NCT02596893|147223085|SUPERIORITY||Stratified difference|-3.7||||0.3784|TWO_SIDED|95.0|-12.0|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.6|-12.0|0.3784
73837338|NCT02596893|147223085|SUPERIORITY||Stratified difference|-4.4||||0.2865|TWO_SIDED|95.0|-12.6|3.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||3.8|-12.6|0.2865
73837339|NCT02596893|147223086|SUPERIORITY||Unstratified CMH|-2.2||||0.3572|TWO_SIDED|95.0|-11.3|7.0|||Cochran-Mantel-Haenszel|p-values were based on the unstratified CMH test when 1 and only 1 of the 2 treatment groups being compared had no subjects in a stratum.|The weighted average of the treatment differences across the strata with the CMH weights.|2-sided 95% CI were based on the unstratified Newcombe method.||7.0|-11.3|0.3572
73837340|NCT02596893|147223086|SUPERIORITY||Stratified difference|4.7||||0.2823|TWO_SIDED|95.0|-8.8|18.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||18.9|-8.8|0.2823
73837341|NCT02596893|147223086|SUPERIORITY||Stratified difference|0.0|||>|0.9999|TWO_SIDED|95.0|-12.8|13.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||13.7|-12.8|> 0.9999
73837342|NCT02596893|147223087|SUPERIORITY||Stratified difference|-0.5||||0.8031|TWO_SIDED|95.0|-6.7|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.9|-6.7|0.8031
73837343|NCT02596893|147223087|SUPERIORITY||Stratified difference|1.4||||0.5583|TWO_SIDED|95.0|-5.1|7.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||7.3|-5.1|0.5583
73837344|NCT02596893|147223087|SUPERIORITY||Stratified difference|-1.0||||0.6123|TWO_SIDED|95.0|-7.2|6.8|||Cochran-Mantel-Haenszel||||The weighted average of the treatment differences across the strata with the CMH weights.|6.8|-7.2|0.6123
73837345|NCT02596893|147223088|SUPERIORITY||Stratified difference|-10.6||||0.0239|TWO_SIDED|95.0|-19.6|-1.4|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||-1.4|-19.6|0.0239
73837346|NCT02596893|147223088|SUPERIORITY||Stratified difference|-1.0||||0.8334|TWO_SIDED|95.0|-10.8|8.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||8.7|-10.8|0.8334
73837347|NCT02596893|147223088|SUPERIORITY||Stratified difference|-3.9||||0.4383|TWO_SIDED|95.0|-13.5|5.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||5.8|-13.5|0.4383
73837348|NCT02596893|147223089|SUPERIORITY||Stratified difference|-1.6||||0.3573|TWO_SIDED|95.0|-8.3|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with CMH weights.|||5.9|-8.3|0.3573
73837349|NCT02596893|147223089|SUPERIORITY||Stratified difference|-2.0||||0.2221|TWO_SIDED|95.0|-8.7|5.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.1|-8.7|0.2221
73837350|NCT02596893|147223089|SUPERIORITY||Stratified difference|-2.0||||0.2578|TWO_SIDED|95.0|-8.7|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.6|-8.7|0.2578
73837351|NCT02596893|147223092|SUPERIORITY||Stratified Difference|0.5||||0.9141|TWO_SIDED|95.0|-8.9|10.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights|||10.0|-8.9|0.9141
73837352|NCT02596893|147223092|SUPERIORITY||Stratified Difference|-3.6||||0.4286|TWO_SIDED|95.0|-12.8|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.6|-12.8|0.4286
73837353|NCT02596893|147223092|SUPERIORITY||Stratified Difference|-2.7||||0.5591|TWO_SIDED|95.0|-12.0|6.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||6.6|-12.0|0.5591
73837354|NCT03052257|147223093|SUPERIORITY||Median Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.15|0.3|||Regression, Linear|||||0.30|0.15|<0.0001
73837355|NCT00004228|147223101|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Regression, Cox|||"A Cox model was used to assess evidence of a difference in event-free survival comparing regimens A1+A2 (A: CCG BFM) to regimens B1+B2 (B: NHL/BFM-95) while adjusting for the other intervention through stratification."||||.97
73837356|NCT00004228|147223101|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Regression, Cox|||"A Cox model was used to assess evidence of a difference in event-free survival comparing A1+B1 (1: no intensification) to A2 +B2 (2: intensification), while adjusting for the other intervention through stratification."||||.63
73837357|NCT02255279|147223109|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.06|||||TWO_SIDED|95.0|3.0|5.51|||ANCOVA|||Geometric mean titers (GMTs), in H1N1 strain of all the tree strains in Subjects 6 to \< 72 months of Age.||5.51|3.00|
73837358|NCT02255279|147223109|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|2.58|||||TWO_SIDED|95.0|2.05|3.25|||ANCOVA|||Geometric mean titers (GMTs), in H3N2 strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.||3.25|2.05|
73837359|NCT02255279|147223109|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.67|||||TWO_SIDED|95.0|3.52|6.2|||ANCOVA|||Geometric mean titers (GMTs), in B strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.||6.20|3.52|
73837360|NCT02255279|147223110|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|17.0|||||TWO_SIDED|95.0|8.1|26.3|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in H1N1 strain after last vaccination with aTIV or TIV in naïve and non-naive subjects.||26.3|8.1|
73863138|NCT01345682|147272239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.004|TWO_SIDED|95.0|0.5|0.89||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.89|0.50|0.0040
73898402|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.587||0.734|TWO_SIDED|95.0|-1.355|0.955||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.955|-1.355|0.734
73837361|NCT02255279|147223110|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|10.0|||||TWO_SIDED|95.0|-1.8|21.0|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in H3N2 strain after last vaccination with aTIV or TIV in naive and non-naive subjects.||21|-1.8|
73837362|NCT02255279|147223110|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|58.0|||||TWO_SIDED|95.0|47.5|68.5|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in B strains after last vaccination with aTIV or TIV in naïve and non naive subjects.||68.5|47.5|
73837363|NCT01524705|147223124|SUPERIORITY||Wilcoxon||||<|0.024||||||Wilcoxon rank sum test was used due to nonnormality distribution|Wilcoxon (Mann-Whitney)|||Two-tailed t test with type I error = 0.05, a sample of 110 participants (55 per group) would give 90% power to detect a difference of a mean change from baseline of 5 CV units (SD = 8) between control and treatment groups. An ANCOVA model, adjusting for baseline value and clinical site, was to be performed. If residual values from the ANCOVA indicated nonnormality in distribution by Shapiro-Wilk testing, a Wilcoxon rank sum test was used instead.||||<0.024
73837364|NCT01524705|147223126|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73837365|NCT01524705|147223127|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
73837366|NCT01755156|147223128|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.55|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-0.34|-0.75|<0.001
73837367|NCT01755156|147223129|SUPERIORITY_OR_OTHER||Difference in %|0.5|||||TWO_SIDED|95.0|-8.8|9.8|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.|||9.8|-8.8|
73837368|NCT01755156|147223130|SUPERIORITY_OR_OTHER||Difference in %|-2.5|||||TWO_SIDED|95.0|-6.6|1.1|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.|||1.1|-6.6|
73837369|NCT01755156|147223131|SUPERIORITY_OR_OTHER||Difference in %|4.5|||||TWO_SIDED|95.0|-3.3|12.3||||||||12.3|-3.3|
73837370|NCT01755156|147223132|SUPERIORITY_OR_OTHER||Difference in %|-14.5||||0.011|TWO_SIDED|95.0|-25.6|-3.4|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-3.4|-25.6|0.011
73837371|NCT01755156|147223133|SUPERIORITY_OR_OTHER||Difference in least squares means|-9.5||||0.01|TWO_SIDED|95.0|-16.7|-2.3|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-2.3|-16.7|0.010
73837372|NCT01755156|147223136|SUPERIORITY_OR_OTHER||Between-group rate difference (%)|19.2|||<|0.001|TWO_SIDED|95.0|10.1|28.0|||Miettinen & Nurminen method|||||28.0|10.1|<0.001
73837373|NCT01755156|147223137|SUPERIORITY_OR_OTHER||Between-group rate difference (%)|4.2||||0.164|TWO_SIDED|95.0|-1.8|10.5|||Miettinen & Nurminen method|||||10.5|-1.8|0.164
73837374|NCT01755156|147223140|SUPERIORITY_OR_OTHER||Difference in least squares means|-27.8||||0.001|TWO_SIDED|95.0|-44.8|-10.8|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-10.8|-44.8|0.001
73837375|NCT01755156|147223141|SUPERIORITY_OR_OTHER||Difference in least squares means|3.7||||0.025|TWO_SIDED|95.0|0.5|6.9|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||6.9|0.5|0.025
73837376|NCT01755156|147223143|SUPERIORITY_OR_OTHER||Kaplan-Meier difference %|-1.2||||0.654|TWO_SIDED|95.0|-7.0|4.7|||Log Rank|||||4.7|-7.0|0.654
73837377|NCT00292370|147223161|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73837378|NCT01292473|147223189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.69||||0.4637|TWO_SIDED|95.0|-2.54|1.16||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||1.16|-2.54|0.4637
73837379|NCT01292473|147223189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.04||||0.0011|TWO_SIDED|95.0|-4.85|-1.24||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-1.24|-4.85|0.0011
73837380|NCT01292473|147223189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.81|||<|0.0001|TWO_SIDED|95.0|-6.49|-3.13||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-3.13|-6.49|<0.0001
73837381|NCT01292473|147223190|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.73||||0.1575|TWO_SIDED|95.0|-6.53|1.07||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||1.07|-6.53|0.1575
73898403|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|3.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73837382|NCT01292473|147223190|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.69||||0.0001||95.0|-11.49|-3.88||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-3.88|-11.49|0.0001
73837383|NCT01292473|147223190|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.4|||<|0.0001|TWO_SIDED|95.0|-16.13|-8.66||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-8.66|-16.13|<0.0001
73837384|NCT01292473|147223191|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.01||||0.0603|TWO_SIDED|95.0|-4.11|0.09||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||0.09|-4.11|0.0603
73837385|NCT01292473|147223191|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.51|||<|0.0001|TWO_SIDED|95.0|-6.65|-2.36||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-2.36|-6.65|<0.0001
73837386|NCT01292473|147223191|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.09|||<|0.0001|TWO_SIDED|95.0|-9.26|-4.93||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-4.93|-9.26|<0.0001
73837387|NCT01292473|147223192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.0478|TWO_SIDED|95.0|1.0|2.05||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between Placebo and Omalizumab 75 mg.||2.05|1.00|0.0478
73837388|NCT01292473|147223192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59||||0.0101|TWO_SIDED|95.0|1.12|2.26||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||2.26|1.12|0.0101
73837389|NCT01292473|147223192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.48|3.03||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.||3.03|1.48|<0.0001
73837390|NCT01292473|147223193|SUPERIORITY_OR_OTHER|||||||0.3419||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.3419
73837391|NCT01292473|147223193|SUPERIORITY_OR_OTHER|||||||0.001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0010
73837392|NCT01292473|147223193|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.||||<0.0001
73837393|NCT01292473|147223194|SUPERIORITY_OR_OTHER|||||||0.4366||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.4366
73837394|NCT01292473|147223194|SUPERIORITY_OR_OTHER|||||||0.0045||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0045
73837395|NCT01292473|147223194|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||||<0.0001
73837396|NCT01292473|147223195|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.48||||0.0082|TWO_SIDED|95.0|-4.32|-0.65||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||-0.65|-4.32|0.0082
73837397|NCT01292473|147223195|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.76|||<|0.0001|TWO_SIDED|95.0|-5.61|-1.9||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-1.90|-5.61|<0.0001
73837398|NCT01292473|147223195|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.15|||<|0.0001|TWO_SIDED|95.0|-9.03|-5.27||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and the omalizumab 300 mg groups.||-5.27|-9.03|<0.0001
73837399|NCT01292473|147223196|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.68||||0.1207|TWO_SIDED|95.0|-3.82|0.45||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||0.45|-3.82|0.1207
73837400|NCT01292473|147223196|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.51||||0.0215|TWO_SIDED|95.0|-4.64|-0.38||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-0.38|-4.64|0.0215
73837401|NCT01292473|147223196|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.79||||0.0004|TWO_SIDED|95.0|-5.85|-1.73||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-1.73|-5.85|0.0004
73837402|NCT01292473|147223197|SUPERIORITY_OR_OTHER|||||||0.1361||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.1361
73837403|NCT01292473|147223197|SUPERIORITY_OR_OTHER|||||||0.0905||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0905
73837404|NCT01292473|147223197|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg.||||<0.0001
73837405|NCT02123511|147223203|SUPERIORITY|||||||0.1232|||||||t-test, 1 sided|||||||0.1232
73837406|NCT02123511|147223204|SUPERIORITY|||||||0.0422|||||||t-test, 1 sided|||||||0.0422
73837407|NCT02123511|147223205|SUPERIORITY|||||||0.5634|||||||t-test, 1 sided|||||||0.5634
73837408|NCT02123511|147223206|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||0.02
73837409|NCT02123511|147223207|SUPERIORITY|||||||0.22|||||||t-test, 1 sided|||||||0.22
73837410|NCT02123511|147223208|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||0.02
73837411|NCT02123511|147223209|SUPERIORITY|||||||0.95|||||||t-test, 1 sided|||||||0.95
73837412|NCT02123511|147223210|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
73837413|NCT02123511|147223211|SUPERIORITY|||||||0.48|||||||t-test, 1 sided|||||||0.48
73837414|NCT02123511|147223212|SUPERIORITY|||||||0.3824|||||||Wilcoxon (Mann-Whitney)|||||||0.3824
73837415|NCT03777176|147223222|SUPERIORITY|The negative binomial regression used region and treatment group as fixed effects, and Baseline hypoglycemic rate as covariate and number of hypoglycemic events during Weeks 2-4 as dependent variable.|Event rate ratio|0.85||||0.5028|TWO_SIDED|95.0|0.54|1.36|||Negative binomial regression|||The primary analysis was performed as a negative binominal regression analysis on the difference of the SMPG-detected hypoglycemia episode rate between treatment groups over the Weeks 2-4.||1.36|0.54|0.5028
73837416|NCT03777176|147223223|SUPERIORITY||Mean Difference (Net)|0.84||||0.6433|TWO_SIDED|95.0|-2.71|4.39||The P value should be interpreted with caution given the procedural issues (hypoglycemia at the beginning of the test, test meals not being the same, and some children only having 1 test) which affected the preplanned statistical evaluation.|ANCOVA|||||4.39|-2.71|0.6433
73837417|NCT03777176|147223224|SUPERIORITY||Mean Difference (Net)|0.15||||0.9653|TWO_SIDED|95.0|-6.48|6.78||There was 1 missing value at Baseline for the dasiglucagon + standard of care group.|ANCOVA|||||6.78|-6.48|0.9653
73837418|NCT03777176|147223225|SUPERIORITY||Event rate ratio|0.93||||0.8114|TWO_SIDED|95.0|0.49|1.74|||Negative binominal regression|The negative binomial regression used region and treatment group as fixed effects, and Baseline hypoglycemic rate as covariate.||||1.74|0.49|0.8114
73837419|NCT03615534|147223245|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line TG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl, ApoA1 = 144.6 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TG level as a covariate, with further adjustments for baseline HDL-C, ApoA1levels.||||0.0001
73837420|NCT03615534|147223246|SUPERIORITY|||||||0.06||||||Results were evaluated in terms of adjusted end line TC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TC level as a covariate, with further adjustments for baseline Non HDL-C and d-LDL-C.||||0.060
73837421|NCT03615534|147223246|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: HDL-C = 31.8 mg/dL,TG= 240.4 mg/dL, ApoA1 = 144.6 mg/dL.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline HDL-C level as a covariate, with further adjustments for baselineTG, ApoA1levels.||||0.0001
73837422|NCT03615534|147223246|SUPERIORITY|||||||0.334||||||Results were evaluated in terms of adjusted end line d-LDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: d-LDL-C= 119.1 mg/dl.TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl,||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline d-LDL-C level as a covariate, with further adjustments for baseline TC and Non HDL-C .||||0.334
73837423|NCT03615534|147223246|SUPERIORITY|||||||0.012||||||Results were evaluated in terms of adjusted end line Non HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: Non HDL-C= 168.0 mg/dl,TC=199.9 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline Non HDL-C level as a covariate, with further adjustments for baseline TC and d-LDL-C.||||0.012
73837424|NCT03615534|147223246|SUPERIORITY|||||||0.001||||||Results were evaluated in terms of adjusted end line RC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1, ApoB=133.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline RC level as a covariate, with further adjustments for baselineTC, Non HDL-C, d-LDL-C, and ApoB.||||0.001
73837425|NCT03615534|147223247|SUPERIORITY|||||||0.058||||||Results were evaluated in terms of adjusted end line ApoA1 levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: ApoA1 = 144.6 mg/dl, TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoA1 level as a covariate, with further adjustments for baseline TG and HDL-C levels.||||0.058
73837426|NCT03615534|147223247|SUPERIORITY|||||||0.067||||||Results were evaluated in terms of adjusted end line ApoB levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:ApoB=133.1, RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoB level as a covariate, with further adjustments for baselineTC, Non HDL-C, dLDL-C, and RC .||||0.067
73837427|NCT03615534|147223248|SUPERIORITY|||||||0.001||||||Results were evaluated in terms of adjusted end line FSG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: FSG= 95.7 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline FSG level as a covariate.||||0.001
73837428|NCT03615534|147223249|SUPERIORITY|||||||0.786||||||Results were evaluated in terms of adjusted end line eGFR levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: eGFR= 88.0 ml/min per 1.73 m\^2.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline eGFR level as a covariate.||||0.786
73837429|NCT03615534|147223250|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line serum uric acid levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: serum uric acid= 5.0 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline serum uric acid level as a covariate.||||0.0001
73837430|NCT03615534|147223251|OTHER|||||||0.201||||||Results were evaluated in terms of adjusted end line AST levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|"Covariates appearing in ANCOVA model are evaluated at the following baseline values: AST= 18.1 IU/L.~."||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline AST level as a covariate.||||0.201
73837431|NCT03615534|147223251|SUPERIORITY|||||||0.033||||||Results were evaluated in terms of adjusted end line ALT levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: ALT= 16.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ALT level as a covariate.||||0.033
73837432|NCT03615534|147223251|SUPERIORITY|||||||0.511||||||Results were evaluated in terms of adjusted end line CK levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: CK= 28.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline CK level as a covariate.||||0.511
73837433|NCT03615534|147223252|OTHER|||||||0.434||||||Results were evaluated in terms of adjusted end line diastolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: diastolic blood pressure= 80.0 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline diastolic blood pressure level as a covariate.||||0.434
73898404|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.579||0.417|TWO_SIDED|95.0|-1.608|0.668||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.668|-1.608|0.417
73837434|NCT03615534|147223252|SUPERIORITY|||||||0.966||||||Results were evaluated in terms of adjusted end line systolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: systolic blood pressure= 121.5 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline systolic blood pressure level as a covariate.||||0.966
73837435|NCT03071965|147223266|SUPERIORITY||Median Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.0881||0.5455|TWO_SIDED|95.0|-0.226|0.12|||Mixed Models Analysis|||||0.120|-0.226|0.5455
73837436|NCT00601107|147223332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||1|TWO_SIDED|95.0|0.17|4.22||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.22|0.17|1.000
73837437|NCT00601107|147223332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.992||95.0|0.13|4.14||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.14|0.13|0.992
73837438|NCT00601107|147223332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||1|TWO_SIDED|95.0|0.15|4.59||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.59|0.15|1.000
73837439|NCT01181128|147223340|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.05|0.13|||negative binomial model|||The null hypothesis for the primary endpoint is no difference between the individualized (tailored) prophylaxis regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have \> 90% power at the 2-sided 0.05 level of significance to detect a 60% reduction in annualized bleeding episodes, based upon this hypothesis test.||0.13|0.05|<0.001
73837440|NCT01181128|147223346|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.24|||<|0.001|TWO_SIDED|95.0|0.12|0.46|||negative binomial model|||||0.46|0.12|<0.001
73837441|NCT00185900|147223378|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
73837442|NCT04595370|147223384|OTHER||F test statistics|1.07||||0.3645|||||||F-Test|||||||0.3645
73837443|NCT04595370|147223385|OTHER||Percent difference between treatment|-33.606||||0.1588|TWO_SIDED|95.0|-62.53|17.644|||Mixed Models Analysis|||||17.644|-62.530|0.1588
73837444|NCT04595370|147223385|OTHER||Percent difference between treatment|-11.826||||0.6846|TWO_SIDED|95.0|-52.195|62.634|||Mixed Models Analysis|||||62.634|-52.195|0.6846
73837445|NCT04595370|147223385|OTHER||Percent difference between treatment|-36.127||||0.1398|TWO_SIDED|95.0|-64.85|16.066|||Mixed Models Analysis|||||16.066|-64.850|0.1398
73837446|NCT01117350|147223457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.54||||0.439|TWO_SIDED|95.0|-3.88|8.93||"If superiority not demonstrated, switching from superiority to non-inferiority considered.~Conclusion of non-inferiority reached if lower limit of 2-sided 95% confidence interval of the difference (insulin glargine - liraglutide) \> or = to - 3.5%"|Chi-squared|||"Superiority testing~H0: Rate measured with insulin glargine = rate measured with liraglutide~H1: Rate measured with insulin glargine ≠ rate measured with liraglutide~Sample size calculation (465 randomized patients per arm) was based on the assumption of an expected success rate of 46% with insulin glargine and 35% with liraglutide, an alpha risk of 5% (2-sided) and a power of 90%, taking into account an estimated non evaluability rate of 10%."||8.93|-3.88|0.439
73837447|NCT04826731|147223486|OTHER|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.||||0.374
73837448|NCT04826731|147223487|OTHER|||||||0.635|||||||Wilcoxon (Mann-Whitney)|||Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.||||0.635
73837449|NCT01245049|147223508|NON_INFERIORITY|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to diphtheria, standardized asymptotic 95% CI for the groups'difference \[Repevax Group minus Boostrix Polio Group\] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.|Percentage difference|0.56|||||TWO_SIDED|95.0|-3.55|3.14|||Standardized asymptotic|||Non-inferiority in terms of booster response to D||3.14|-3.55|
73837450|NCT01245049|147223508|NON_INFERIORITY|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to tetanus, standardized asymptotic 95% CI for the groups' difference \[Repevax Group minus Boostrix Polio Group\] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.|Percentage difference|1.7|||||TWO_SIDED|95.0|-2.43|4.9||||||Non-inferiority in terms of booster response to T||4.9|-2.43|
73837451|NCT01245049|147223510|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: Upper limit (UL) of the 95% confidence interval (CI) on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) was lower than or equal to (≤) 2.|Difference in adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.65|1.28|||ANCOVA|||Immune response difference to anti-Polio 1 antigen||1.28|0.65|
73837452|NCT01245049|147223510|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|0.78|||||TWO_SIDED|95.0|0.54|1.12|||ANCOVA|||Immune response difference to anti-Polio 2 antigen||1.12|0.54|
73837453|NCT01245049|147223510|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|1.3|||||TWO_SIDED|95.0|0.93|1.84|||ANCOVA|||Immune response difference to anti-Polio 3 antigen||1.84|0.93|
73837454|NCT01027754|147223541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Fisher Exact|||||||0.03
73837455|NCT01027754|147223542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|||||||Fisher Exact|||||||0.24
73837456|NCT01027754|147223551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
73837457|NCT01557244|147223564|SUPERIORITY|||||||0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an analysis of covariance (ANCOVA) model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||0.0001
73837458|NCT01557244|147223564|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||<.0001
73837459|NCT01557244|147223564|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||<.0001
73837460|NCT01557244|147223564|OTHER||Difference in Least square (LS) Mean|-29.06|||||TWO_SIDED|95.0|-71.42|13.31||||||||13.31|-71.42|
73837461|NCT01557244|147223564|OTHER||Difference in LS Mean|-3.82|||||TWO_SIDED|95.0|-45.87|38.23||||||||38.23|-45.87|
73837462|NCT01557244|147223565|SUPERIORITY|||||||0.2334|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.2334
73837463|NCT01557244|147223565|SUPERIORITY|||||||0.5087|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.5087
73837464|NCT01557244|147223565|SUPERIORITY|||||||0.3333|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.3333
73837465|NCT01557244|147223565|OTHER||Difference in LS Mean|-0.47|||||TWO_SIDED|95.0|-7.28|6.33||||||||6.33|-7.28|
73837466|NCT01557244|147223565|OTHER||Difference in LS Mean|0.82|||||TWO_SIDED|95.0|-5.96|7.6||||||||7.60|-5.96|
73837467|NCT01557244|147223567|SUPERIORITY|||||||0.0336|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0336
73837468|NCT01557244|147223567|SUPERIORITY|||||||0.0327|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0327
73837469|NCT01557244|147223567|SUPERIORITY|||||||0.0017|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0017
73837470|NCT01557244|147223567|OTHER||Difference in LS Mean|-10.78|||||TWO_SIDED|95.0|-48.75|27.19||||||||27.19|-48.75|
73837471|NCT01557244|147223567|OTHER||Difference in LS Mean|-15.25|||||TWO_SIDED|95.0|-50.15|19.64||||||||19.64|-50.15|
73837472|NCT01557244|147223568|SUPERIORITY|||||||0.0679|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.0679
73837473|NCT01557244|147223568|SUPERIORITY|||||||0.1233|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.1233
73837474|NCT01557244|147223568|SUPERIORITY|||||||0.0019|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.0019
73837475|NCT01557244|147223568|OTHER||Difference in LS Mean|-4.96|||||TWO_SIDED|95.0|-14.81|4.89||||||||4.89|-14.81|
73837476|NCT01557244|147223568|OTHER||Difference in LS Mean|-5.95|||||TWO_SIDED|95.0|-15.85|3.95||||||||3.95|-15.85|
73837477|NCT01557244|147223569|SUPERIORITY|||||||0.0116|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0116
73837478|NCT01557244|147223569|SUPERIORITY|||||||0.0765|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0765
73837479|NCT01557244|147223569|SUPERIORITY|||||||0.0061|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0061
73837480|NCT01557244|147223569|OTHER||Difference in LS Mean|-0.1|||||TWO_SIDED|95.0|-1.16|0.97||||||||0.97|-1.16|
73837481|NCT01557244|147223569|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.74|1.31||||||||1.31|-0.74|
73837482|NCT01557244|147223570|SUPERIORITY|||||||0.0787|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0787
73837483|NCT01557244|147223570|SUPERIORITY|||||||0.0727|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0727
73837484|NCT01557244|147223570|SUPERIORITY|||||||0.0666|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0666
73837485|NCT01557244|147223570|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.45|0.54||||||||0.54|-0.45|
73837486|NCT01557244|147223570|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-0.49|0.52||||||||0.52|-0.49|
73837487|NCT01557244|147223571|SUPERIORITY|||||||0.0111|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0111
73837488|NCT01557244|147223571|SUPERIORITY|||||||0.0171|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0171
73837489|NCT01557244|147223571|SUPERIORITY|||||||0.0028|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0028
73837490|NCT01557244|147223571|OTHER||Difference in LS Mean|0.14|||||TWO_SIDED|95.0|-0.53|0.82||||||||0.82|-0.53|
73837491|NCT01557244|147223571|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.54|0.84||||||||0.84|-0.54|
73837492|NCT01557244|147223572|SUPERIORITY|||||||0.0496|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||0.0496
73837493|NCT01557244|147223572|SUPERIORITY|||||||0.0002|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||0.0002
73837494|NCT01557244|147223572|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||<.0001
73837495|NCT01557244|147223572|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.09|1.19||||||||1.19|-0.09|
73837496|NCT01557244|147223572|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-0.52|0.77||||||||0.77|-0.52|
73837497|NCT01557244|147223573|SUPERIORITY|||||||0.0298|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.0298
73837498|NCT01557244|147223573|SUPERIORITY|||||||0.1417|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.1417
73837499|NCT01557244|147223573|SUPERIORITY|||||||0.6219|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.6219
73837500|NCT01557244|147223573|OTHER||Difference in LS Mean|-0.48|||||TWO_SIDED|95.0|-1.28|0.32||||||||0.32|-1.28|
73837501|NCT01557244|147223573|OTHER||Difference in LS Mean|-0.36|||||TWO_SIDED|95.0|-1.24|0.52||||||||0.52|-1.24|
73837502|NCT01557244|147223574|SUPERIORITY|||||||0.7986|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.7986
73837503|NCT01557244|147223574|SUPERIORITY|||||||0.2313|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.2313
73837504|NCT01557244|147223574|SUPERIORITY|||||||0.7571|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.7571
73837505|NCT01557244|147223574|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-42.11|42.0||||||||42.00|-42.11|
73837506|NCT01557244|147223574|OTHER||Difference in LS Mean|15.07|||||TWO_SIDED|95.0|-26.5|56.63||||||||56.63|-26.50|
73837507|NCT01557244|147223575|SUPERIORITY|||||||0.061|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0610
73837508|NCT01557244|147223575|SUPERIORITY|||||||0.0048|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0048
73837509|NCT01557244|147223575|SUPERIORITY|||||||0.01|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0100
73837510|NCT01557244|147223575|OTHER||Difference in LS Mean|-16.43|||||TWO_SIDED|95.0|-63.14|30.29||||||||30.29|-63.14|
73837511|NCT01557244|147223575|OTHER||Difference in LS Mean|1.28|||||TWO_SIDED|95.0|-46.0|48.57||||||||48.57|-46.00|
73837512|NCT01557244|147223576|SUPERIORITY|||||||0.2246|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.2246
73837513|NCT01557244|147223576|SUPERIORITY|||||||0.0003|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.0003
73837514|NCT01557244|147223576|SUPERIORITY|||||||0.0161|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.0161
73837515|NCT01557244|147223576|OTHER||Difference in LS Mean|-18.24|||||TWO_SIDED|95.0|-61.0|24.53||||||||24.53|-61.00|
73837516|NCT01557244|147223576|OTHER||Difference in LS Mean|18.86|||||TWO_SIDED|95.0|-22.93|60.65||||||||60.65|-22.93|
73837517|NCT01313676|147223614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.137|TWO_SIDED|95.0|0.739|1.042|||Cox Proportional Hazards Model|||||1.042|0.739|0.137
73837518|NCT01313676|147223614|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|12.2|||||TWO_SIDED|95.0|-4.2|26.1|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||26.1|-4.2|
73837519|NCT01313676|147223614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.911||||0.284|TWO_SIDED|95.0|0.767|1.081|||Cox Proportional Hazards Model|||||1.081|0.767|0.284
73837520|NCT01313676|147223614|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|8.9|||||TWO_SIDED|95.0|-8.1|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.3|-8.1|
73837521|NCT01313676|147223614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.962||||0.655|TWO_SIDED|95.0|0.813|1.139|||Cox Proportional Hazards Model|||||1.139|0.813|0.655
73837522|NCT01313676|147223614|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|3.8|||||TWO_SIDED|95.0|-13.9|18.7|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||18.7|-13.9|
73837523|NCT01313676|147223614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.964||||0.681|TWO_SIDED|95.0|0.808|1.149|||Cox Proportional Hazards Model|||||1.149|0.808|0.681
73837524|NCT01313676|147223614|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|3.6|||||TWO_SIDED|95.0|-14.9|19.2|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||19.2|-14.9|
73837525|NCT01313676|147223614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912||||0.299|TWO_SIDED|95.0|0.767|1.085|||Cox Proportional Hazards Model|||||1.085|0.767|0.299
73837526|NCT01313676|147223614|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|8.8|||||TWO_SIDED|95.0|-8.5|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.3|-8.5|
73837527|NCT01313676|147223615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.4||0.019|TWO_SIDED|95.0|1.0|15.0|||Mixed Models Analysis|||||15|1|0.019
73837528|NCT01313676|147223615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.5||0.026|TWO_SIDED|95.0|1.0|14.0|||Mixed Models Analysis|||||14|1|0.026
73837529|NCT01313676|147223615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.4||0.654|TWO_SIDED|95.0|-8.0|5.0|||Mixed Models Analysis|||||5|-8|0.654
73837530|NCT01313676|147223615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|3.4||0.913|TWO_SIDED|95.0|-6.0|7.0|||Mixed Models Analysis|||||7|-6|0.913
73837531|NCT01313676|147223615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|3.4||0.004|TWO_SIDED|95.0|3.0|16.0|||Mixed Models Analysis|||||16|3|0.004
73837532|NCT01313676|147223616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.926||||0.475|TWO_SIDED|95.0|0.75|1.143|||Cox Proportional Hazards Model|||||1.143|0.750|0.475
73837533|NCT01313676|147223616|SUPERIORITY_OR_OTHER||Percent reduction in risk of CV event|7.4|||||TWO_SIDED|95.0|-14.3|25.0|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||25.0|-14.3|
73837534|NCT01313676|147223616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.317|TWO_SIDED|95.0|0.723|1.111|||Cox Proportional Hazards Model|||||1.111|0.723|0.317
73837535|NCT01313676|147223616|SUPERIORITY_OR_OTHER||Percent reduction in risk of CV event|10.4|||||TWO_SIDED|95.0|-11.1|27.7|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||27.7|-11.1|
73837536|NCT01313676|147223616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.908|TWO_SIDED|95.0|0.802|1.217|||Cox Proportional Hazards Model|||||1.217|0.802|0.908
73837537|NCT01313676|147223616|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|1.2|||||TWO_SIDED|95.0|-21.7|19.8|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||19.8|-21.7|
73837538|NCT01313676|147223616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.033||||0.763|TWO_SIDED|95.0|0.834|1.281|||Cox Proportional Hazards Model|||||1.281|0.834|0.763
73837539|NCT01313676|147223616|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|-3.3|||||TWO_SIDED|95.0|-28.1|16.6|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||16.6|-28.1|
73837540|NCT01313676|147223616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.938||||0.545|TWO_SIDED|95.0|0.761|1.155|||Cox Proportional Hazards Model|||||1.155|0.761|0.545
73837541|NCT01313676|147223616|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|6.2|||||TWO_SIDED|95.0|-15.5|23.9|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.9|-15.5|
73837542|NCT00944645|147223617|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis I: The Cmax of nicotinuric acid (NUA) following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of NUA Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.98||||||90.0|0.93|1.03||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.03|0.93|
73837543|NCT00944645|147223618|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis II: The total urinary excretion of niacin and niacin metabolites following the administration of MK0524 (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of total urinary excretion of niacin and its metabolites is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.94||||||90.0|0.89|0.98||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||0.98|0.89|
73837544|NCT00944645|147223619|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis III: The AUC0-infinity of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 AUC0-∞ is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.0||||||95.0|0.95|1.05||||||"Group B: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~Group A: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.05|0.95|
73837545|NCT00944645|147223620|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis IV: The Cmax of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.02||||||95.0|0.96|1.09||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.09|0.96|
73837546|NCT03537729|147223621|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED|95.0|0.18|0.91||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.91|0.18|<.01
73837547|NCT03537729|147223621|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.18||0.96|TWO_SIDED|95.0|-0.35|0.37||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.37|-0.35|.96
73837548|NCT03537729|147223621|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.18|<|0.01|TWO_SIDED|95.0|-0.89|-0.18||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||-0.18|-0.89|<.01
73837549|NCT03537729|147223621|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|95.0|-0.09|0.38||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.38|-0.09|.23
73837550|NCT03537729|147223621|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.12||0.9|TWO_SIDED|95.0|-0.25|0.22||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.22|-0.25|.90
73837551|NCT03537729|147223621|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED|95.0|-0.38|0.07||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.07|-0.38|.17
73837552|NCT03537729|147223621|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.58|TWO_SIDED|95.0|-0.16|0.28||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.28|-0.16|.58
73837553|NCT03537729|147223621|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.15|TWO_SIDED|95.0|-0.06|0.37||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.37|-0.06|.15
73863139|NCT01345682|147272240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0268|TWO_SIDED|95.0|0.56|0.97||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.97|0.56|0.0268
73863140|NCT02440789|147272264|OTHER|||||||0.56|||||||t-test, 2 sided|paired t-test||||||0.56
73863141|NCT02440789|147272266|OTHER|||||||0.11|||||||t-test, 2 sided|paired t-test||||||0.11
73837554|NCT03537729|147223621|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.1||0.37|TWO_SIDED|95.0|-0.11|0.29||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.29|-0.11|.37
73837555|NCT03537729|147223622|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.04|TWO_SIDED|95.0|-0.07|-0.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||-0.01|-0.07|.04
73837556|NCT03537729|147223622|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1|TWO_SIDED|95.0|-0.07|0.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.01|-0.07|.10
73837557|NCT03537729|147223622|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.69|TWO_SIDED|95.0|-0.03|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.04|-0.03|.69
73837558|NCT03537729|147223623|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.65||||0.04|TWO_SIDED|95.0|0.44|0.99||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for cues divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means for two arms was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.99|0.44|0.04
73837559|NCT03537729|147223623|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.59||||0.01|TWO_SIDED|95.0|0.39|0.9||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.90|0.39|.01
73837560|NCT03537729|147223623|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.9||||0.61|TWO_SIDED|95.0|0.6|1.35||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for cues. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||1.35|0.60|.61
73837561|NCT03537729|147223623|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|1.26||||0.26|TWO_SIDED|95.0|0.84|1.88||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for cues divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||1.88|0.84|.26
73837562|NCT03537729|147223623|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.79||||0.25|TWO_SIDED|95.0|0.53|1.19||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||1.19|0.53|.25
73863142|NCT02440789|147272268|OTHER|||||||0.93|||||||t-test, 2 sided|paired t-test; results less than the analysis lower limit (0.7 cp/mL) were imputed to a value of one half the analysis lower limit.||||||0.93
73863143|NCT02440789|147272270|OTHER|||||||0.041|||||||t-test, 2 sided|paired t-test||||||0.041
73837563|NCT03537729|147223623|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.63||||0.03|TWO_SIDED|95.0|0.42|0.94||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for cues. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.94|0.42|.03
73837564|NCT03537729|147223624|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|1.69||0.31|TWO_SIDED|95.0|-5.03|1.6||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Cues minus control.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||1.60|-5.03|.31
73837565|NCT03537729|147223624|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|1.75||0.66|TWO_SIDED|95.0|-4.23|2.66||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Spaced retrieval minus control.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||2.66|-4.23|.66
73837566|NCT03537729|147223624|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.65||0.57|TWO_SIDED|95.0|-2.3|4.17||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||4.17|-2.30|.57
73837567|NCT01902303|147223638|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Chi-squared|||||||>.5000
73837568|NCT01902303|147223639|SUPERIORITY_OR_OTHER|||||||0.3835|TWO_SIDED||||||Chi-squared|||||||.3835
73837569|NCT04359680|147223662|SUPERIORITY||Odds Ratio (OR)|1.029||||0.9434|TWO_SIDED|95.0|0.4696|2.2546|||Cochran-Mantel-Haenszel|||||2.2546|0.4696|0.9434
73837570|NCT04359680|147223663|SUPERIORITY||Odds Ratio (OR)|1.1162||||0.6805|TWO_SIDED|95.0|0.6623|1.8813|||Cochran-Mantel-Haenszel|||||1.8813|0.6623|0.6805
73837571|NCT04359680|147223665|SUPERIORITY|||||||0.3459|||||||Cochran-Mantel-Haenszel|||||||0.3459
73837572|NCT01654250|147223674|SUPERIORITY_OR_OTHER||Least Square(LS) Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-10.9|-3.1|||Mixed Models Analysis|||Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point, and time point by treatment interaction as main effects and participant intercept as a random effect.||-3.1|-10.9|<0.001
73837573|NCT01654250|147223675|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-12.7|-3.7|||Mixed Models Analysis|||Hour 0.75 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-3.7|-12.7|<0.001
73837574|NCT01654250|147223675|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 0.75 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||0.133
73837575|NCT01654250|147223675|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-17.3|-8.3|||Mixed Models Analysis|||Hour 2 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-8.3|-17.3|<0.001
73837576|NCT01654250|147223675|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 2 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
73837577|NCT01654250|147223675|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-16.8|-7.8|||Mixed Models Analysis|||Hour 4 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-7.8|-16.8|<0.001
73837578|NCT01654250|147223675|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 4 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
73837579|NCT01654250|147223675|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-12.3|-3.3|||Mixed Models Analysis|||Hour 8 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effect and participant intercept as a random effect.||-3.3|-12.3|<0.001
73837580|NCT01654250|147223675|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 8 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
73837581|NCT01654250|147223675|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.28||0.133|TWO_SIDED|95.0|-7.9|1.1|||Mixed Models Analysis|||Hour 10 post-dose: Nominal p-value -treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.1|-7.9|0.133
73837582|NCT01654250|147223675|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 10 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.||||0.133
73837583|NCT01654250|147223675|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.28||0.206|TWO_SIDED|95.0|-7.4|1.6|||Mixed Models Analysis|||Hour 12 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.6|-7.4|0.206
73837584|NCT01654250|147223675|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 12 post-dose: Adjusted p-values are generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||0.133
73837585|NCT01654250|147223675|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.28||0.496|TWO_SIDED|95.0|-6.0|2.9|||Mixed Models Analysis|||Hour 13 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||2.9|-6.0|0.496
73837586|NCT01654250|147223675|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 13 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.||||0.133
73837587|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.56||0.007|TWO_SIDED|95.0|-2.6|-0.4|||Mixed Models Analysis|||Hour 0.75 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.4|-2.6|0.007
73837588|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||Hour 2 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-1.4|-3.6|<0.001
73837589|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-3.4|-1.2|||Mixed Models Analysis|||Hour 4 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-1.2|-3.4|<0.001
73837590|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.56||0.003|TWO_SIDED|95.0|-2.8|-0.6|||Mixed Models Analysis|||Hour 8 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.6|-2.8|0.003
73837591|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.56||0.097|TWO_SIDED|95.0|-2.0|0.2|||Mixed Models Analysis|||Hour 10 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.2|-2.0|0.097
73837592|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.49|TWO_SIDED|95.0|-1.5|0.7|||Mixed Models Analysis|||Hour 12 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.7|-1.5|0.490
73837593|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.56||0.164|TWO_SIDED|95.0|-1.9|0.3|||Mixed Models Analysis|||Hour 13 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.3|-1.9|0.164
73837594|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.94||0.004|TWO_SIDED|95.0|-4.6|-0.9|||Mixed Models Analysis|||Hour 0.75 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.9|-4.6|0.004
73837595|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 2 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-2.1|-5.8|<0.001
73837596|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 4 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-2.1|-5.8|<0.001
73837597|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.94||0.042|TWO_SIDED|95.0|-3.8|-0.1|||Mixed Models Analysis|||Hour 8 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.1|-3.8|0.042
73837598|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.94||0.118|TWO_SIDED|95.0|-3.3|0.4|||Mixed Models Analysis|||Hour 10 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.4|-3.3|0.118
73863144|NCT02440789|147272273|OTHER|||||||0.008|||||||t-test, 2 sided|paired t-test||||||0.008
73863145|NCT02440789|147272275|OTHER|||||||0.26|||||||t-test, 2 sided|paired t-test||||||0.26
73863146|NCT02440789|147272277|OTHER|||||||0.75|||||||t-test, 2 sided|paired t-test||||||0.75
73837599|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.94||0.342|TWO_SIDED|95.0|-2.7|1.9|||Mixed Models Analysis|||Hour 12 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.9|-2.7|0.342
73837600|NCT01654250|147223676|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.94||0.962|TWO_SIDED|95.0|-1.8|1.9|||Mixed Models Analysis|||Hour 13 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.9|-1.8|0.962
73837601|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean difference|25.3|STANDARD_ERROR_OF_MEAN|11.12||0.024|TWO_SIDED|95.0|3.4|47.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||47.1|3.4|0.024
73837602|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1|STANDARD_ERROR_OF_MEAN|11.12||0.001|TWO_SIDED|95.0|14.2|57.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||57.9|14.2|0.001
73837603|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean Difference|34.7|STANDARD_ERROR_OF_MEAN|11.12||0.002|TWO_SIDED|95.0|12.8|56.6|||Mixed Models Analysis|||Hour 4 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||56.6|12.8|0.002
73837604|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean Difference|29.3|STANDARD_ERROR_OF_MEAN|11.12||0.009|TWO_SIDED|95.0|7.4|51.1|||Mixed Models Analysis|||Hour 8 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||51.1|7.4|0.009
73837605|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|11.12||0.261|TWO_SIDED|95.0|-9.3|34.4|||Mixed Models Analysis|||Hour 10 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||34.4|-9.3|0.261
73837606|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1|STANDARD_ERROR_OF_MEAN|11.12||0.175|TWO_SIDED|95.0|-6.7|37.0|||Mixed Models Analysis|||Hour 12 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||37.0|-6.7|0.175
73837607|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean Difference|18.7|STANDARD_ERROR_OF_MEAN|11.12||0.094|TWO_SIDED|95.0|-3.2|40.5|||Mixed Models Analysis|||Hour 13 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||40.5|-3.2|0.094
73837608|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean Difference|22.6|STANDARD_ERROR_OF_MEAN|11.44||0.049|TWO_SIDED|95.0|0.1|45.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||45.1|0.1|0.049
73837609|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean Difference|34.4|STANDARD_ERROR_OF_MEAN|11.44||0.003|TWO_SIDED|95.0|11.9|56.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||56.9|11.9|0.003
73837610|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|STANDARD_ERROR_OF_MEAN|11.44||0.004|TWO_SIDED|95.0|10.5|55.4|||Mixed Models Analysis|||Hour 4 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||55.4|10.5|0.004
73837611|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean Difference|27.0|STANDARD_ERROR_OF_MEAN|11.44||0.019|TWO_SIDED|95.0|4.5|49.5|||Mixed Models Analysis|||Hour 8 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||49.5|4.5|0.019
73837612|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean difference|8.6|STANDARD_ERROR_OF_MEAN|11.44||0.451|TWO_SIDED|95.0|-13.9|31.1|||Mixed Models Analysis|||Hour 10 (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||31.1|-13.9|0.451
73837613|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|11.44||0.394|TWO_SIDED|95.0|-12.7|32.2|||Mixed Models Analysis|||Hour 12 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||32.2|-12.7|0.394
73863147|NCT02440789|147272279|OTHER|||||||0.97|||||||t-test, 2 sided|paired t-test||||||0.97
73863148|NCT02440789|147272281|OTHER|||||||0.7|||||||t-test, 2 sided|paired t-test||||||0.7
73837614|NCT01654250|147223677|SUPERIORITY_OR_OTHER||LS Mean difference|8.3|STANDARD_ERROR_OF_MEAN|11.44||0.466|TWO_SIDED|95.0|-14.1|30.8|||Mixed Models Analysis|||Hour 13 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||30.8|-14.1|0.466
73837615|NCT03606213|147223726|OTHER|||||||0.56||||||P-value week 14 versus baseline (Cohort A, arm 1; placebo)|Wilcoxon (Mann-Whitney)|||||||0.56
73837616|NCT01429623|147223745|SUPERIORITY||Odds Ratio (OR)|1.55|||<|0.16|TWO_SIDED|95.0|0.74|3.25|||Log Rank|||||3.25|0.74|<0.16
73837617|NCT01429623|147223746|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.24|<|0.61|TWO_SIDED||||||Mixed Models Analysis|||||||<0.61
73837618|NCT01429623|147223747|SUPERIORITY||Mean Difference (Net)|-0.066|STANDARD_ERROR_OF_MEAN|0.085|<|0.32|TWO_SIDED||||||Mixed Models Analysis|||||||<0.32
73837619|NCT01429623|147223748|SUPERIORITY||Mean Difference (Net)|0.79|STANDARD_ERROR_OF_MEAN|1.17|<|0.97|TWO_SIDED||||||Mixed Models Analysis|||||||<0.97
73837620|NCT01750281|147223750|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.12||||0.584|TWO_SIDED|90.0|0.8|1.61|||Cox Proportional Hazards|||||1.61|0.80|0.584
73837621|NCT01750281|147223750|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|0.92||||0.69|TWO_SIDED|90.0|0.65|1.31|||Cox Proportional Hazards|||||1.31|0.65|0.690
73837622|NCT01750281|147223751|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.43||||0.126|TWO_SIDED|90.0|0.97|2.13|||Cox Proportional Hazards|||||2.13|0.97|0.126
73837623|NCT01750281|147223751|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.18||||0.485|TWO_SIDED|90.0|0.8|1.78|||Cox Proportional Hazards|||||1.78|0.80|0.485
73837624|NCT00793611|147223755|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.07|||||||t-test, 2 sided|19 degrees of freedom||ITT between group differences in change scores compared for behavioral therapy and hypnotherapy groups. Power analysis: This is a pilot study underpowered find between group differences based on our power analysis(a 20% difference between groups would require 88 women, assuming 80% power and α=0.05 based on Freeman's study cited later). The purpose of this pilot study is to evaluate the feasibility of the larger study and determine the appropriate control intervention and outcomes||||.07
73837625|NCT00793611|147223756|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||intent to treat.||||.17
73837626|NCT00793611|147223757|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||intent to treat||||.009
73837627|NCT03757715|147223767|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|||||||0.16
73837628|NCT03757715|147223768|SUPERIORITY|||||||0.42|||||||t-test, 1 sided|||||||0.42
73837629|NCT01550965|147223818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.001|TWO_SIDED|95.0|16.08|18.73|||paired t-test, 2 sided|||Hypothesis testing for the first ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.||18.73|16.08|<0.001
73837630|NCT01550965|147223819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1383.81|||<|0.001|TWO_SIDED|95.0|-1586.36|-1181.26|||Paired t-test, 2 sided|||Hypothesis testing for the second ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.||-1181.26|-1586.36|<0.001
73837631|NCT01550965|147223820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1297.77|||<|0.001|TWO_SIDED|95.0|-1562.17|-1033.36|||Paired t-test, 2 sided|||||-1033.36|-1562.17|<0.001
73837632|NCT01550965|147223821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4308.32|||<|0.001|TWO_SIDED|95.0|-4985.13|-3631.51|||Paired t-test, 2 sided|||||-3631.51|-4985.13|<0.001
73837633|NCT01550965|147223822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.3|||<|0.001|TWO_SIDED|95.0|-9.83|-4.78|||Paired t-test, 2 sided|||||-4.78|-9.83|<0.001
73837634|NCT01550965|147223823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.37|||<|0.001|TWO_SIDED|95.0|21.5|27.25|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness.||27.25|21.50|<0.001
73837635|NCT01550965|147223823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.95|||<|0.001|TWO_SIDED|95.0|15.42|22.48|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects.||22.48|15.42|<0.001
73837636|NCT01550965|147223823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|||<|0.001|TWO_SIDED|95.0|3.89|8.5|||Paired t-test, 2 sided)|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience.||8.50|3.89|<0.001
73837637|NCT01550965|147223823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.6|||<|0.001|TWO_SIDED|95.0|19.55|25.64|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction.||25.64|19.55|<0.001
73837638|NCT01550965|147223824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.85|||<|0.001|TWO_SIDED|95.0|-5.42|-4.27|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization.||-4.27|-5.42|<0.001
73837639|NCT01550965|147223824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.11|0.09|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during emergency department visits.||0.09|-0.11|0.830
73837640|NCT01550965|147223824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92|||<|0.001|TWO_SIDED|95.0|-1.18|-0.66|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during primary care doctor visits.||-0.66|-1.18|<0.001
73837641|NCT01550965|147223825|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||McNemar|||Statistical analysis for percentage of participants with absence of blood in stool from week 0 to week 26.||||<0.001
73837642|NCT01550965|147223826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||<|0.001|TWO_SIDED|95.0|10.21|12.02|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 2.||12.02|10.21|<0.001
73837643|NCT01550965|147223826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.38|||<|0.001|TWO_SIDED|95.0|14.2|16.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 8.||16.56|14.20|<0.001
73863149|NCT02440789|147272283|OTHER|||||||0.47|||||||t-test, 2 sided|paired t-test||||||0.47
73863150|NCT02440789|147272285|OTHER|||||||0.72|||||||t-test, 2 sided|paired t-test||||||0.72
73863151|NCT02440789|147272287|OTHER|||||||0.28|||||||t-test, 2 sided|paired t-test||||||0.28
73837644|NCT01550965|147223826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.77|||<|0.001|TWO_SIDED|95.0|13.57|15.96|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||15.96|13.57|<0.001
73837645|NCT01550965|147223826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.001|TWO_SIDED|95.0|16.08|18.73|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 26.||18.73|16.08|<0.001
73837646|NCT01550965|147223827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.69|-0.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 2.||-0.57|-0.69|<0.001
73837647|NCT01550965|147223827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||<|0.001|TWO_SIDED|95.0|-1.16|-1.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 8.||-1.00|-1.16|<0.001
73837648|NCT01550965|147223827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.001|TWO_SIDED|95.0|-0.95|-0.77|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-0.77|-0.95|<0.001
73837649|NCT01550965|147223827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.001|TWO_SIDED|95.0|-1.23|-1.06|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 26.||-1.06|-1.23|<0.001
73837650|NCT01550965|147223828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.22|||<|0.001|TWO_SIDED|95.0|-3.46|-2.99|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 2.||-2.99|-3.46|<0.001
73837651|NCT01550965|147223828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.06|||<|0.001|TWO_SIDED|95.0|-4.37|-3.76|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 8.||-3.76|-4.37|<0.001
73837652|NCT01550965|147223828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.01|||<|0.001|TWO_SIDED|95.0|-3.36|-2.66|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-2.66|-3.36|<0.001
73837653|NCT01550965|147223828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|||<|0.001|TWO_SIDED|95.0|-4.43|-3.72|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 26.||-3.72|-4.43|<0.001
73837654|NCT01550965|147223829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||<|0.001|TWO_SIDED|95.0|0.08|0.11|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 2.||0.11|0.08|<0.001
73837655|NCT01550965|147223829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.001|TWO_SIDED|95.0|0.11|0.15|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 8.||0.15|0.11|<0.001
73837656|NCT01550965|147223829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||<|0.001|TWO_SIDED|95.0|0.1|0.14|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||0.14|0.10|<0.001
73837657|NCT01550965|147223829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.12|0.17|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 26.||0.17|0.12|<0.001
73837658|NCT01550965|147223830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.62|||<|0.001|TWO_SIDED|95.0|-12.07|-5.18|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 2.||-5.18|-12.07|<0.001
73837659|NCT01550965|147223830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.22|||<|0.001|TWO_SIDED|95.0|-16.27|-8.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 8.||-8.16|-16.27|<0.001
73837660|NCT01550965|147223830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.61|||<|0.001|TWO_SIDED|95.0|-15.82|-7.4|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-7.40|-15.82|<0.001
73837661|NCT01550965|147223830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.43|||<|0.001|TWO_SIDED|95.0|-15.5|-7.35|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 26.||-7.35|-15.50|<0.001
73837662|NCT01550965|147223831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.56|||<|0.001|TWO_SIDED|95.0|-20.0|-13.12|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 2.||-13.12|-20.00|<0.001
73837663|NCT01550965|147223831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.95|||<|0.001|TWO_SIDED|95.0|-26.93|-18.97|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 8.||-18.97|-26.93|<0.001
73837664|NCT01550965|147223831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.68|||<|0.001|TWO_SIDED|95.0|-25.69|-17.67|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-17.67|-25.69|<0.001
73837665|NCT01550965|147223831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.45|||<|0.001|TWO_SIDED|95.0|-28.33|-20.58|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 26.||-20.58|-28.33|<0.001
73837666|NCT01550965|147223832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.34|||<|0.001|TWO_SIDED|95.0|-22.1|-14.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 2.||-14.57|-22.10|<0.001
73837667|NCT01550965|147223832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.54|||<|0.001|TWO_SIDED|95.0|-31.08|-22.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 8.||-22.00|-31.08|<0.001
73863152|NCT02440789|147272289|OTHER|||||||0.7|||||||t-test, 2 sided|paired t-test||||||0.7
73863153|NCT02440789|147272291|OTHER|||||||0.28|||||||t-test, 2 sided|paired t-test||||||0.28
73863154|NCT02440789|147272293|OTHER|||||||0.77|||||||t-test, 2 sided|paired t-test||||||0.77
73837668|NCT01550965|147223832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.33|||<|0.001|TWO_SIDED|95.0|-29.97|-20.7|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-20.70|-29.97|<0.001
73837669|NCT01550965|147223832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.22|||<|0.001|TWO_SIDED|95.0|-33.5|-24.93|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 26.||-24.93|-33.50|<0.001
73837670|NCT01550965|147223833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.001|TWO_SIDED|95.0|-20.47|-15.85|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 2.||-15.85|-20.47|<0.001
73837671|NCT01550965|147223833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.43|||<|0.001|TWO_SIDED|95.0|-28.3|-22.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 8.||-22.56|-28.30|<0.001
73837672|NCT01550965|147223833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.42|||<|0.001|TWO_SIDED|95.0|-27.33|-21.5|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-21.50|-27.33|<0.001
73837673|NCT01550965|147223833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.22|||<|0.001|TWO_SIDED|95.0|-30.28|-24.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 26.||-24.16|-30.28|<0.001
73837674|NCT03760640|147223834|SUPERIORITY||LS Mean Difference|-0.86||||0.339|TWO_SIDED|90.0|-2.35|0.63|||Mixed Models Analysis|||||0.63|-2.35|0.339
73837675|NCT03760640|147223835|SUPERIORITY||LS Mean Difference|3.0||||0.011|TWO_SIDED|90.0|1.1|4.9|||Mixed Models Analysis|||||4.90|1.10|0.011
73837676|NCT03760640|147223836|SUPERIORITY||LS Mean Difference|0.56||||0.557|TWO_SIDED|90.0|-1.02|2.14|||Mixed Models Analysis|||||2.14|-1.02|0.557
73837677|NCT03760640|147223837|SUPERIORITY||LS Mean Difference|-0.04||||0.548|TWO_SIDED|90.0|-0.15|0.07|||Mixed Models Analysis|||||0.07|-0.15|0.548
73837678|NCT03760640|147223839|SUPERIORITY||LS Mean Difference|0.49||||0.577|TWO_SIDED|90.0|-0.97|1.94|||Mixed Models Analysis|||||1.94|-0.97|0.577
73837679|NCT03016403|147223840|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.0057|TWO_SIDED|95.0|0.52|2.98||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.98|0.52|0.0057
73898405|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|4.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73837680|NCT03016403|147223841|SUPERIORITY||Mean Difference (Final Values)|1.46||||0.0243|TWO_SIDED|95.0|0.19|2.73||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.||2.73|0.19|0.0243
73837681|NCT03016403|147223842|SUPERIORITY||Mean Difference (Final Values)|-15.31||||0.0061|TWO_SIDED|95.0|-26.23|-4.39||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of an interaction between time and intervention arm.|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.||-4.39|-26.23|0.0061
73837682|NCT03016403|147223843|SUPERIORITY||Mean Difference (Final Values)|-7.73||||0.21|TWO_SIDED|95.0|-19.73|4.27||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||4.27|-19.73|0.21
73837683|NCT03016403|147223844|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.052|TWO_SIDED|95.0|-0.01|3.05||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||3.05|-0.01|0.052
73837684|NCT03016403|147223845|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.214|TWO_SIDED|95.0|-0.52|2.36||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.36|-0.52|0.214
73837685|NCT03016403|147223846|SUPERIORITY||Mean Difference (Final Values)|-4.16||||0.0134|TWO_SIDED|95.0|-7.45|-0.87||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||-0.87|-7.45|0.0134
73837686|NCT03016403|147223847|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.42|TWO_SIDED|95.0|-0.9|2.12||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.12|-0.9|0.42
73837687|NCT03016403|147223848|SUPERIORITY||Mean Difference (Final Values)|1.77||||0.0269|TWO_SIDED|95.0|0.2|3.34||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||3.34|0.2|0.0269
73837688|NCT03016403|147223849|SUPERIORITY||Mean Difference (Final Values)|2.56||||0.0044|TWO_SIDED|95.0|0.8|4.32||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||4.32|0.8|0.0044
73837689|NCT05463705|147223850|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.88|1.96||||||||1.96|0.88|
73837690|NCT05463705|147223850|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system),72,73 an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||||1.52|0.66|
73837691|NCT05463705|147223851|SUPERIORITY|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.83|1.61||||||||1.61|0.83|
73837692|NCT05463705|147223851|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.64|1.3||||||||1.30|0.64|
73837693|NCT05463705|147223852|SUPERIORITY||Difference in HbA1c %|0.18|||||TWO_SIDED|95.0|-0.07|0.43||||||||0.43|-0.07|
73837694|NCT05463705|147223852|SUPERIORITY||Difference in HbA1c %|0.06|||||TWO_SIDED|95.0|-0.22|0.34||||||||0.34|-0.22|
73837695|NCT04299425|147223865|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
73837696|NCT04299425|147223866|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
73837697|NCT04299425|147223868|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
73837698|NCT04299425|147223869|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
73837699|NCT01655069|147223878|OTHER||Adjusted change from baseline|-0.95|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.19|-0.71|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.71|-1.19|
73837700|NCT01655069|147223878|OTHER||Adjusted change from baseline|-1.11|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.34|-0.88|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.88|-1.34|
73837701|NCT01655069|147223878|OTHER||Adjusted change from baseline|-1.26|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-1.53|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-1.53|
73837702|NCT01655069|147223878|OTHER||Adjusted change from baseline|-1.39|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.63|-1.16|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.16|-1.63|
73837703|NCT01655069|147223878|OTHER||Adjusted change from baseline|-1.54|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-1.76|-1.32|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.32|-1.76|
73837704|NCT01655069|147223878|OTHER||Adjusted change from baseline|-1.56|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-1.81|-1.31|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-1.31|-1.81|
73837705|NCT01655069|147223878|OTHER||Adjusted change from baseline|-1.93|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-2.19|-1.67|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.67|-2.19|
73837706|NCT01655069|147223878|OTHER||Adjusted change from baseline|-0.93|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.62|-0.23|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.23|-1.62|
73837707|NCT01655069|147223878|OTHER||Adjusted change from baseline|-1.38|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.09|-0.68|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.68|-2.09|
73837708|NCT01655069|147223878|OTHER||Adjusted change from baseline|-1.4|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.09|-0.7|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.70|-2.09|
73837709|NCT01655069|147223878|OTHER||Adjusted change from baseline|-1.58|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.27|-0.88|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.88|-2.27|
73837710|NCT01655069|147223878|OTHER||Adjusted change from baseline|-1.8|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.5|-1.1|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.10|-2.50|
73837711|NCT01655069|147223878|OTHER||Adjusted change from baseline|-1.57|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.29|-0.85|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.85|-2.29|
73837712|NCT01655069|147223878|OTHER||Adjusted change from baseline|-2.0|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.83|-1.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.17|-2.83|
73837713|NCT01655069|147223879|OTHER||Adjusted change from baseline|1.35|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.97|1.73|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||1.73|0.97|
73863155|NCT02440789|147272295|OTHER|||||||0.93|||||||t-test, 2 sided|paired t-test||||||0.93
73863156|NCT02440789|147272297|OTHER|||||||0.65|||||||t-test, 2 sided|paired t-test||||||0.65
73837714|NCT01655069|147223879|OTHER||Adjusted change from baseline|1.43|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.02|1.83|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||1.83|1.02|
73837715|NCT01655069|147223879|OTHER||Adjusted change from baseline|1.72|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|1.27|2.16|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.16|1.27|
73959477|NCT02326649|147454571|OTHER||Mean Difference (Final Values)|-0.427|STANDARD_ERROR_OF_MEAN|0.305||0.183|TWO_SIDED|95.0|-1.081|0.227|||Regression, Linear|||Diastolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||0.227|-1.081|0.183
73837716|NCT01655069|147223879|OTHER||Adjusted change from baseline|1.8|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|1.36|2.24|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.24|1.36|
73837717|NCT01655069|147223879|OTHER||Adjusted change from baseline|2.21|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|1.74|2.67|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.67|1.74|
73837718|NCT01655069|147223879|OTHER||Adjusted change from baseline|2.28|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|1.79|2.77|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.77|1.79|
73837719|NCT01655069|147223879|OTHER||Adjusted change from baseline|2.84|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|2.19|3.49|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.49|2.19|
73837720|NCT01655069|147223879|OTHER||Adjusted change from baseline|1.53|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.17|2.89|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.89|0.17|
73837721|NCT01655069|147223879|OTHER||Adjusted change from baseline|1.9|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|0.52|3.27|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.27|0.52|
73837722|NCT01655069|147223879|OTHER||Adjusted change from baseline|1.75|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.39|3.1|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.10|0.39|
73837723|NCT01655069|147223879|OTHER||Adjusted change from baseline|2.69|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|1.34|4.05|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||4.05|1.34|
73837724|NCT01655069|147223879|OTHER||Adjusted change from baseline|3.07|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|1.7|4.43|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||4.43|1.70|
73837725|NCT01655069|147223879|OTHER||Adjusted change from baseline|2.45|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|1.05|3.85|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.85|1.05|
73837726|NCT01655069|147223879|OTHER||Adjusted change from baseline|3.93|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|2.34|5.53|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||5.53|2.34|
73863157|NCT02440789|147272299|OTHER|||||||0.22|||||||t-test, 2 sided|paired t-test||||||0.22
73959478|NCT02326649|147454571|OTHER||Mean Difference (Final Values)|0.557|STANDARD_ERROR_OF_MEAN|0.452||0.238|TWO_SIDED|95.0|-0.411|1.526|||Regression, Linear|||Systolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||1.526|-0.411|0.238
73837727|NCT01655069|147223880|OTHER||Adjusted change from baseline|-0.98|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.27|-0.69|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.69|-1.27|
73837728|NCT01655069|147223880|OTHER||Adjusted change from baseline|-1.15|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.44|-0.86|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.86|-1.44|
73837729|NCT01655069|147223880|OTHER||Adjusted change from baseline|-1.31|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.6|-1.02|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-1.02|-1.60|
73837730|NCT01655069|147223880|OTHER||Adjusted change from baseline|-1.22|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.51|-0.93|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.93|-1.51|
73837731|NCT01655069|147223880|OTHER||Adjusted change from baseline|-1.5|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.8|-1.21|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.21|-1.80|
73837732|NCT01655069|147223880|OTHER||Adjusted change from baseline|-1.52|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-1.83|-1.22|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.22|-1.83|
73837733|NCT01655069|147223880|OTHER||Adjusted change from baseline|-1.83|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-2.22|-1.43|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.43|-2.22|
73837734|NCT01655069|147223880|OTHER||Adjusted change from baseline|-0.93|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.73|-0.13|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.13|-1.73|
73837735|NCT01655069|147223880|OTHER||Adjusted change from baseline|-0.94|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.48|-0.4|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.40|-1.48|
73837736|NCT01655069|147223880|OTHER||Adjusted change from baseline|-0.81|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.46|-0.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.17|-1.46|
73837737|NCT01655069|147223880|OTHER||Adjusted change from baseline|-0.91|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-1.53|-0.28|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.28|-1.53|
73837738|NCT01655069|147223880|OTHER||Adjusted change from baseline|-0.71|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.8|-0.38|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.38|-1.80|
73837739|NCT01655069|147223880|OTHER||Adjusted change from baseline|-1.18|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.92|-0.44|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.44|-1.92|
73837740|NCT01655069|147223880|OTHER||Adjusted change from baseline|-1.79|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.59|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-2.59|
73863158|NCT02440789|147272301|OTHER|||||||0.031|||||||t-test, 2 sided|paired t-test||||||0.031
73863159|NCT02440789|147272303|OTHER|||||||0.005|||||||t-test, 2 sided|paired t-test||||||0.005
73837741|NCT01655069|147223881|OTHER||Adjusted change from baseline|-0.74|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.65|0.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||0.17|-1.65|
73837742|NCT01655069|147223881|OTHER||Adjusted change from baseline|-1.3|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.23|-0.36|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.36|-2.23|
73837743|NCT01655069|147223881|OTHER||Adjusted change from baseline|-1.14|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.06|-0.22|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.22|-2.06|
73837744|NCT01655069|147223881|OTHER||Adjusted change from baseline|-1.28|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.18|-0.38|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.38|-2.18|
73837745|NCT01655069|147223881|OTHER||Adjusted change from baseline|-1.04|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.95|-0.12|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.12|-1.95|
73837746|NCT01655069|147223881|OTHER||Adjusted change from baseline|-1.96|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.93|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-2.93|
73837747|NCT01655069|147223881|OTHER||Adjusted change from baseline|-2.2|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-3.48|-0.93|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.93|-3.48|
73837748|NCT06399471|147223883|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.126||||||One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.|ANOVA|||An ANOVA was used to compare the Power Knee and the C-Leg 4.0 when used during Ten Meter Walking Test.||||0.126
73837749|NCT06399471|147223883|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.015|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the Rheo when used during Ten Meter Walking Test.||||0.015
73837750|NCT06399471|147223883|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.852|||||||ANOVA|||An ANOVA was used to compare the Rheo and the C-Leg 4.0 when used during Ten Meter Walking Test.||||0.852
73837751|NCT06399471|147223884|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.003|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the C-Leg 4.0 when used during Two Meter Walking Test.||||0.003
73837752|NCT06399471|147223884|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.027|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the Rheo when used during Two Meter Walking Test.||||0.027
73837753|NCT06399471|147223884|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.425|||||||ANOVA|||An ANOVA was used to compare the Rheo and the C-Leg 4.0 when used during Two Meter Walking Test.||||0.425
73837754|NCT06399471|147223885|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.006|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Power Knee and the C-Leg 4.0.||||0.006
73837755|NCT06399471|147223885|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.236|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Power Knee and the Rheo.||||0.236
73837756|NCT06399471|147223885|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.118|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Rheo and the C-Leg 4.0.||||0.118
73837757|NCT06399471|147223886|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.687|||||||ANOVA|||An ANOVA was used to compare the Power Knee, the C-Leg 4.0, and the Rheo when used during Stance Time Asymmetry Index test.||||0.687
73837758|NCT06399471|147223887|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.082|||||||ANOVA|||An ANOVA was used to compare the Power Knee, the C-Leg 4.0, and Rheo when used during the Narrowing beam walking test.||||0.082
73837759|NCT06399471|147223888|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.943|||||||ANOVA|||An ANOVA was used to compare the reported falls when for when the Power Knee, C-Leg 4.0, and the Rheo were used.||||0.943
73863160|NCT02440789|147272305|OTHER|||||||0.69|||||||t-test, 2 sided|paired t-test||||||0.69
73898406|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.589||0.252|TWO_SIDED|95.0|-1.836|0.482||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.482|-1.836|0.252
73837760|NCT06399471|147223889|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.535|||||||ANOVA|||An ANOVA was used to compare the Physiological cost index for when the Power Knee, the C-Leg 4.0, and the Rheo were used.||||0.535
73837761|NCT06399471|147223890|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.229|||||||ANOVA|||An ANOVA was used to compare the Stair Ascent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.229
73837762|NCT06399471|147223891|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.528|||||||ANOVA|||An ANOVA was used to compare the Stair Descent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.528
73837763|NCT06399471|147223892|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.144|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Power Knee and the C-Leg 4.0.||||0.144
73837764|NCT06399471|147223892|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.024|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Power Knee and the Rheo.||||0.024
73837765|NCT06399471|147223892|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.949|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Rheo and the C-Leg 4.0.||||0.949
73837766|NCT06399471|147223893|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.051|||||||ANOVA|||An ANOVA was used to compare the Ramp Descent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.051
73837767|NCT06399471|147223894|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.367|||||||ANOVA|||An ANOVA was used to compare the Steps per Day for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.367
73837768|NCT06083493|147223905|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
73837769|NCT06083493|147223906|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
73837770|NCT00147537|147223909|SUPERIORITY_OR_OTHER||||||=|0.027|TWO_SIDED||||||binomial test|||A one-sided p-value for H0: objective response rate \<=0.28 using exact binomial test at level 0.05.||||=0.027
73837771|NCT00147537|147223910|SUPERIORITY_OR_OTHER||||||=|0.121|TWO_SIDED||||||binomial test|||A One-sided p-value for H0: objective response rate \<=0.30 using exact binomial test at level 0.05.||||=0.121
73837772|NCT00345592|147223940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.987|||||TWO_SIDED|95.0|0.684|1.503||||||||1.503|0.684|
73837773|NCT02006654|147223948|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.46||0.2365|TWO_SIDED|95.0|-1.45|0.36||Corrected for multiplicity|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for idalopirdine at significance level 5%.||0.36|-1.45|0.2365
73837774|NCT02006654|147223949|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4064|TWO_SIDED|95.0|-0.09|0.23||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.||0.23|-0.09|0.4064
73837775|NCT02006654|147223950|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.63||0.4064|TWO_SIDED|95.0|-0.57|1.92||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.||1.92|-0.57|0.4064
73837776|NCT00563316|147223995|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.894|1.074|||||Ratio of Cycle 2 : Cycle 1|||1.074|0.894|
73837777|NCT00563316|147223996|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.898|||||TWO_SIDED|90.0|0.819|0.985|||||Ratio of Cycle 2 : Cycle 1|||0.985|0.819|
73837778|NCT00563316|147223997|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.897|||||TWO_SIDED|90.0|0.818|0.983|||||Ratio of Cycle 2 : Cycle 1|||0.983|0.818|
73837779|NCT05181657|147224006|OTHER|The intervention effect was determined via a two sided, 0.05 level of significance, multivariable Poisson regression model, with Intervention group as the primary predictor.|Risk Ratio (RR)|1.45|||<|0.05|TWO_SIDED|95.0|1.18|1.78||"Alpha significance levels used:~For the primary predictor (i.e., intervention group): alpha=0.05; For covariates: alpha=0.10; For interactions: alpha=0.15"|Poisson Regression||The estimate refers to the relative risk of getting a COVID-19 test onsite (Intervention/Control). Also, the above estimate is from the unadjusted Poisson regression model (i.e., model not adjusted for covariates and interactions).|To assess whether the active intervention was more successful than the control condition at increasing COVID-19 testing, we used univariable and multivariable Poisson regression models, with whether one received onsite testing right after the intervention as the outcome and intervention group as the main predictor. Potential clustering due to the randomization by week was accounted for by specifying an exchangeable correlation structure for participants who were recruited during the same week.||1.78|1.18|<0.05
73837780|NCT03339453|147224014|NON_INFERIORITY|95% Confidence Interval of the treatment differences in treatment success rate.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.52|1.52||||||||1.52|-1.52|
73837781|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||0.367|TWO_SIDED||||||Fisher Exact|||All bleeds||||.367
73837782|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Fisher Exact|||All bleeds||||.104
73837783|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||0.864|TWO_SIDED||||||Fisher Exact|||All bleeds||||.864
73837784|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Fisher Exact|||All bleeds||||.002
73837785|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||1.000
73837786|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.029
73837787|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.807
73837788|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.002
73837789|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major bleeds||||1.000
73959479|NCT03698708|147454581|SUPERIORITY||cohen's d|0.88|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73837790|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||Fisher Exact|||Major bleeds||||0.119
73837791|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major bleeds||||1.000
73837792|NCT00504556|147224046|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||Fisher Exact|||Major bleeds||||0.023
73898407|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73837793|NCT03280615|147224057|SUPERIORITY|||||||0.257|||||||Fisher Exact|||A Fisher exact test was performed||||0.257
73837794|NCT03280615|147224058|SUPERIORITY|||||||0.231|||||||Fisher Exact|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups||||0.231
73837795|NCT03280615|147224059|SUPERIORITY|||||||0.043|||||||Mixed Models Analysis|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups||||0.043
73837796|NCT02683954|147224060|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality of numerical data distribution was examined by the Shapiro-Wilk. Normally distributed numerical variables were presented as mean±SD and inter-group differences were compared using unpaired t test. Skewed numerical variables were presented as median and interquartile range and between-group differences were compared using Mann-Whitney U test. Ordinal data were compared using the chi-squared test for trend. Correlations among numerical variables were tested by Spearman rank correlation.||||0.05
73837797|NCT03142451|147224087|SUPERIORITY||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|0.749||0.0031|TWO_SIDED|95.0|0.75|3.68|||ANCOVA|Analysis of covariance (ANCOVA) model includes treatment, baseline inflammatory lesion count, and analysis center.||||3.68|0.75|0.0031
73837798|NCT03142451|147224088|SUPERIORITY||Risk Ratio (RR)|1.21||||0.0273|TWO_SIDED|95.0|1.022|1.434||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.434|1.022|0.0273
73837799|NCT03142451|147224089|SUPERIORITY||Risk Ratio (RR)|1.21||||0.0171|TWO_SIDED|95.0|1.028|1.425||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.425|1.028|0.0171
73837800|NCT03142451|147224090|SUPERIORITY||Mean Difference (Final Values)|7.62|STANDARD_ERROR_OF_MEAN|2.626||0.0039|TWO_SIDED|95.0|2.46|12.77|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||||12.77|2.46|0.0039
73837801|NCT03142451|147224091|SUPERIORITY||Mean Difference (Final Values)|2.63|STANDARD_ERROR_OF_MEAN|0.747||0.0004|TWO_SIDED|95.0|1.16|4.09|||ANCOVA|ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.||Statistical analysis for Week 4||4.09|1.16|0.0004
73837802|NCT03142451|147224091|SUPERIORITY||Mean Difference (Final Values)|3.09|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|1.62|4.56|||ANCOVA|ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.||Statistical analysis for Week 8||4.56|1.62|<0.0001
73837803|NCT03142451|147224092|SUPERIORITY||Risk Ratio (RR)|1.685||||0.0201|TWO_SIDED|95.0|1.085|2.616||P-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical analysis for Week 4||2.616|1.085|0.0201
73837804|NCT03142451|147224092|SUPERIORITY||Risk Ratio (RR)|1.191||||0.1278|TWO_SIDED|95.0|0.951|1.492||P-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical analysis for Week 8||1.492|0.951|0.1278
73898408|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.669||0.827|TWO_SIDED|95.0|-1.17|1.462||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.462|-1.170|0.827
73959480|NCT03698708|147454582|SUPERIORITY||cohen's d|0.22|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73837805|NCT00090402|147224094|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0|||||Regression, Linear|Adjusted for age and body mass index||||||0.83
73837806|NCT01133977|147224138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.23|0.75||||||The current study was not powered or designed to determine superiority of the '20 mg Lenvatinib + Dacarbazine (Phase 2)' arm compared with 'Dacarbazine (Phase 2) ' arm.||0.75|0.23|
73837807|NCT01368185|147224166|SUPERIORITY_OR_OTHER_LEGACY||% change SUA from baseline|4.6|STANDARD_DEVIATION|0.9|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SUA minus baseline SUA.|Comparison between Month 3 and Baseline||||<0.01
73837808|NCT01368185|147224167|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||||||<0.0001
73837809|NCT01368185|147224168|SUPERIORITY_OR_OTHER_LEGACY||% change DBP from Baseline|-7.1|STANDARD_DEVIATION|0.4|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 DBP minus baseline DBP (n=1239).|Comparison between Month 3 and Baseline||||<0.01
73837810|NCT01368185|147224169|SUPERIORITY_OR_OTHER_LEGACY||% change SBP from Baseline|-9.1|STANDARD_DEVIATION|0.3|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SBP minus baseline SBP (n=1245).|Comparison between Month 3 and Baseline||||<0.01
73837811|NCT03636269|147224170|SUPERIORITY||Odds Ratio (OR)|1.61||||0.02|TWO_SIDED|95.0|1.08|2.41|||Cui, Hung, Wang|||||2.41|1.08|0.020
73837812|NCT03636269|147224171|SUPERIORITY||Odds Ratio (OR)|1.77||||0.01|TWO_SIDED|95.0|1.14|2.74|||Cui, Hung, Wang|||||2.74|1.14|0.010
73837813|NCT03636269|147224172|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.29||0.171|TWO_SIDED|95.0|-4.3|0.8|||ANCOVA|||||0.8|-4.3|0.171
73837814|NCT03636269|147224173|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.35||0.002|TWO_SIDED|95.0|-1.7|-0.4|||ANCOVA|||||-0.4|-1.7|0.002
73837815|NCT03992482|147224174|OTHER|||||||1|||||||Kruskal-Wallis|||||||1.000
73837816|NCT03992482|147224175|OTHER|||||||0.0044|||||||Mixed Models Analysis|||||||0.0044
73837817|NCT03992482|147224176|OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
73837818|NCT01507103|147224177|SUPERIORITY_OR_OTHER||Effect estimate|-0.04||||0.794|TWO_SIDED|95.0|-0.72|0.65||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an analysis of covariance (ANCOVA) model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.65|-0.72|0.794
73837819|NCT01507103|147224177|SUPERIORITY_OR_OTHER||Effect estimate|-0.2||||0.794|TWO_SIDED|95.0|-0.82|0.43||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.43|-0.82|0.794
73837820|NCT01507103|147224177|SUPERIORITY_OR_OTHER||Effect estimate|0.16||||0.794|TWO_SIDED|95.0|-0.49|0.82||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.82|-0.49|0.794
73837821|NCT01507103|147224177|SUPERIORITY_OR_OTHER||Effect estimate|0.02||||0.654|TWO_SIDED|95.0|-0.52|0.57||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.57|-0.52|0.654
73898409|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|4.69|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73837822|NCT01507103|147224177|SUPERIORITY_OR_OTHER||Effect estimate|-0.19||||0.654|TWO_SIDED|95.0|-0.69|0.31||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.31|-0.69|0.654
73837823|NCT01507103|147224177|SUPERIORITY_OR_OTHER||Effect estimate|0.21||||0.654|TWO_SIDED|95.0|-0.31|0.74||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.74|-0.31|0.654
73837824|NCT01507103|147224178|SUPERIORITY_OR_OTHER||LS Means estimate|-0.03||||0.921|TWO_SIDED|95.0|-0.73|0.67|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.67|-0.73|0.921
73863161|NCT02440789|147272307|OTHER|||||||0.008|||||||t-test, 2 sided|paired t-test||||||0.008
73863162|NCT03875664|147272358|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73959481|NCT03698708|147454583|SUPERIORITY||cohen's d|0.05|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73959482|NCT03698708|147454584|SUPERIORITY||cohen's d|0.14|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73837825|NCT01507103|147224178|SUPERIORITY_OR_OTHER||LS Means estimate|-0.2||||0.921|TWO_SIDED|95.0|-0.83|0.44|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.44|-0.83|0.921
73837826|NCT01507103|147224178|SUPERIORITY_OR_OTHER||LS Means estimate|0.17||||0.921|TWO_SIDED|95.0|-0.5|0.83|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.83|-0.50|0.921
73837827|NCT01507103|147224178|SUPERIORITY_OR_OTHER||LS Means estimate|0.02||||0.89|TWO_SIDED|95.0|-0.54|0.58|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.58|-0.54|0.890
73837828|NCT01507103|147224178|SUPERIORITY_OR_OTHER||LS Means estimate|-0.19||||0.89|TWO_SIDED|95.0|-0.7|0.31|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.31|-0.70|0.890
73837829|NCT01507103|147224178|SUPERIORITY_OR_OTHER||LS Means estimate|0.21||||0.89|TWO_SIDED|95.0|-0.32|0.74|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.74|-0.32|0.890
73837830|NCT04535362|147224221|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.63||0.93|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.93
73837831|NCT04535362|147224222|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.3||0.68|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.68
73837832|NCT04535362|147224224|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.51||0.37|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.37
73837833|NCT04535362|147224225|SUPERIORITY||Mean Difference (Net)|1.26|STANDARD_ERROR_OF_MEAN|0.98||0.2|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.20
73837834|NCT03074643|147224236|SUPERIORITY|||||||0.16|||||||ANCOVA|Adjusted for age, sex, race||||||0.16
73837835|NCT03074643|147224236|SUPERIORITY|||||||0.45|||||||ANCOVA|Adjusted for age, sex, race||||||0.45
73837836|NCT03074643|147224237|SUPERIORITY|||||||0.81|||||||ANCOVA|Adjusted for age, sex, race||||||0.81
73837837|NCT03074643|147224237|SUPERIORITY|||||||0.8|||||||ANCOVA|Adjusted for age, sex, race||||||0.80
73837838|NCT03074643|147224238|SUPERIORITY|||||||0.56|||||||ANCOVA|Adjusted for age, sex, race||||||0.56
73837839|NCT03074643|147224238|SUPERIORITY|||||||0.96|||||||ANCOVA|Adjusted for age, sex, race||||||0.96
73837840|NCT03074643|147224239|SUPERIORITY|||||||0.76|||||||ANCOVA|Adjusted for age, sex, race||||||0.76
73837841|NCT03074643|147224239|SUPERIORITY|||||||0.45|||||||ANCOVA|Adjusted for age, sex, race||||||0.45
73837842|NCT03074643|147224240|SUPERIORITY|||||||0.75|||||||ANCOVA|Adjusted for age, sex, race||||||0.75
73837843|NCT03074643|147224240|SUPERIORITY|||||||0.95|||||||ANCOVA|Adjusted for age, sex, race||||||0.95
73837844|NCT03074643|147224241|SUPERIORITY|||||||0.06|||||||ANCOVA|Adjusted for age, sex, race||||||0.06
73959483|NCT03698708|147454585|SUPERIORITY||cohen's d|0.09|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73959484|NCT03698708|147454586|SUPERIORITY||Mean Difference (Final Values)|-4.16|||||TWO_SIDED|95.0|-10.07|1.74|||ANOVA|||||1.74|-10.07|
73837845|NCT03074643|147224241|SUPERIORITY|||||||0.22|||||||ANCOVA|Adjusted for age, sex, race||||||0.22
73837846|NCT03074643|147224242|SUPERIORITY|||||||0.48|||||||ANCOVA|Adjusted for age, sex, race||||||0.48
73837847|NCT03074643|147224242|SUPERIORITY|||||||0.22|||||||ANCOVA|Adjusted for age, sex, race||||||0.22
73837848|NCT03156621|147224339|SUPERIORITY||Least squares (LS) mean difference|-35.6|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|95.0|-51.2|-19.9||P-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM||p-value vs Placebo|||-19.9|-51.2|<0.0001
73837849|NCT03156621|147224340|SUPERIORITY||Least squares (LS) mean difference|-29.8|STANDARD_ERROR_OF_MEAN|6.3|<|0.0001|TWO_SIDED|95.0|-42.3|-17.3||p-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM|||||-17.3|-42.3|< 0.0001
73837850|NCT03156621|147224341|SUPERIORITY||Least squares (LS) mean difference|-32.9|STANDARD_ERROR_OF_MEAN|7.4|<|0.0001|TWO_SIDED|95.0|-47.6|-18.2||P-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM|||||-18.2|-47.6|< 0.0001
73837851|NCT03156621|147224342|SUPERIORITY||Least squares (LS) mean difference|-26.5|STANDARD_DEVIATION|6.2|<|0.0001|TWO_SIDED|95.0|-38.9|-14.0||P-value taken from MMRM (mixed-effect model with repeated measures) analysis.|MMRM|||||-14.0|-38.9|< 0.0001
73837852|NCT03156621|147224343|SUPERIORITY||Odds Ratio, log|12.2|||=|0.0004|TWO_SIDED|95.0|3.1|48.8|||Regression, Logistic|||||48.8|3.1|= 0.0004
73837853|NCT03156621|147224344|SUPERIORITY||Odds Ratio, log|36.5|||=|0.001|TWO_SIDED|95.0|4.3|308.9|||Regression, Logistic|||||308.9|4.3|= 0.0010
73837854|NCT03156621|147224345|SUPERIORITY||Mean Difference (Final Values)|-28.4|STANDARD_DEVIATION|6.7|<|0.0001|TWO_SIDED|95.0|-41.5|-15.2|||Regression model|||||-15.2|-41.5|< 0.0001
73837855|NCT03156621|147224346|SUPERIORITY||Odds Ratio (OR)|17.7|||=|0.0017|TWO_SIDED|95.0|3.3||Maximum likelihood estimate does not exist||Exact Conditional Logistic Regression||||||3.3|= 0.0017
73837856|NCT03156621|147224347|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.8|=|0.3541|TWO_SIDED|95.0|-4.1|11.3||P-value taken from MMRM (mixed-effect model with repeated measures) analysis.|MMRM|||||11.3|-4.1|= 0.3541
73837857|NCT03156621|147224348|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-25.2|2.6||||||||2.6|-25.2|
73837858|NCT03156621|147224349|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_DEVIATION|3.6|||TWO_SIDED|95.0|-3.6|10.7||||||||10.7|-3.6|
73837859|NCT03156621|147224350|SUPERIORITY||Least squares (LS) mean difference|-35.6|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-51.2|-19.9||||||||-19.9|-51.2|
73837860|NCT03156621|147224351|SUPERIORITY||Least squares (LS) mean difference|-29.8|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-43.3|-17.3||||||||-17.3|-43.3|
73837861|NCT03156621|147224352|SUPERIORITY||Least squares (LS) mean difference|-32.9|STANDARD_ERROR_OF_MEAN|7.4|||TWO_SIDED|95.0|-47.6|-18.2||||||||-18.2|-47.6|
73837862|NCT03156621|147224353|SUPERIORITY||Least squares (LS) mean difference|-26.5|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-28.9|-14.0||||||||-14.0|-28.9|
73837863|NCT03156621|147224354|SUPERIORITY||Mean Difference (Final Values)|-28.4|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-41.5|-15.2||||||||-15.2|-41.5|
73837864|NCT03156621|147224355|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.1|11.3||||||||11.3|-4.1|
73837865|NCT03156621|147224356|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-25.2|2.6||||||||2.6|-25.2|
73837866|NCT03156621|147224357|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-3.6|10.7||||||||10.7|-3.6|
73837867|NCT03156621|147224358|SUPERIORITY||Odds Ratio (OR)|12.2|||||TWO_SIDED|95.0|3.1|48.8||||||≥15% reduction||48.8|3.1|
73837868|NCT03156621|147224358|SUPERIORITY|≥ 30% reduction|Odds Ratio (OR)|36.5|||||TWO_SIDED|95.0|4.3|308.9||||||||308.9|4.3|
73837869|NCT03156621|147224358|SUPERIORITY||Odds Ratio (OR)|17.7|||||TWO_SIDED|95.0|3.3||Maximum likelihood estimate does not exist|||||≥ 50% reduction|||3.3|
73837870|NCT03156621|147224359|SUPERIORITY||Least squares (LS) mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.6|-0.1||||||||-0.1|-0.6|
73837871|NCT02222181|147224440|SUPERIORITY_OR_OTHER|||||||0.23|||||||t-test, 1 sided|||||||0.23
73837872|NCT02222181|147224441|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
73837873|NCT02222181|147224442|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 1 sided|||||||0.03
73837874|NCT02222181|147224443|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73837875|NCT02222181|147224444|SUPERIORITY_OR_OTHER|||||||0.025|||||||t-test, 1 sided|||||||0.025
73837876|NCT02222181|147224445|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73837877|NCT02222181|147224446|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
73837878|NCT00472641|147224464|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Random Regression Mixed Effects Modeling|||||||<0.00001
73837879|NCT00472641|147224465|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Random Regression Mixed Effects Modeling|||||||<0.00001
73837880|NCT01933425|147224470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.05|TWO_SIDED|95.0|0.07|0.59|||t-test, 2 sided|||||0.59|0.07|<0.05
73837881|NCT01933425|147224471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|||<|0.05|TWO_SIDED|95.0|0.06|0.54|||t-test, 2 sided|||||0.54|0.06|<0.05
73837882|NCT00063232|147224514|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||paired t-test|||"self-controlled comparison of NASH activity index at 48 weeks and baseline. Null hypothesis is no change."||||<0.001
73837883|NCT00063232|147224515|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Fisher Exact|||self-controlled comparison of serum aminotransferase levels at 48 weeks and baseline. Null hypothesis: No change||||0.04
73837884|NCT00063232|147224516|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||paired t-test|||||||0.04
73837885|NCT02151604|147224517|OTHER||Pearson's coefficient|-0.57||||0.041|TWO_SIDED||||||Pearson's correlation analysis|||Correlation with field of irradiation||||0.041
73837886|NCT02151604|147224519|OTHER||Pearson's coefficient|0.6||||0.037|TWO_SIDED|||||Pearson's correlation coefficient: 0.60|Pearson's Correlation Analysis|0.60||Correlation of change in ventilation signal with that of alveolar volume (VA)||||0.037
73837887|NCT02151604|147224519|OTHER||Pearson's correlation coefficient|0.7||||0.012|TWO_SIDED||||||Pearson's correlation analysis|Pearson's correlation coefficient: 0.70||Correlation of change in ventilation signal with that of diffusing capacity for carbon monoxide(TLCO)||||0.012
73959485|NCT03495713|147454590|OTHER||||||||||||||||||Descriptive analysis only based limited enrollments.|||
73837888|NCT02151604|147224519|OTHER||Pearson's correlation coefficient|-0.85||||0.032|TWO_SIDED||||||Pearson's correlation analysis|R = -0.85||Correlation of change in ventilation signal with that of residual volume (RV)||||0.032
73837889|NCT02151604|147224519|OTHER||Pearson's correlation coefficient|-0.95||||0.004|TWO_SIDED||||||Pearson's correlation analysis|R = -0.95||Correlation of change in ventilation signal with that of functional residual capacity (FRC)||||0.004
73837890|NCT02151604|147224519|OTHER||Pearson's correlation coefficient|-0.88||||0.012|TWO_SIDED||||||Pearson's correlation analysis|Pearson's correlation coefficient = -0.88||Correlation of change in ventilation signal with that of inspiratory capacity(IC)||||0.012
73837891|NCT00324857|147224536|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||"Please note that although the outcome is measured using a Likert scale, for the analysis we dichotomized the results.~P-value not adjusted for multiple comparison. Lastly, \<0.05 is the actual computed P-value."|Regression, Logistic|||Comparisons of the baseline demographic and clinical characteristics (TKR) across the 4 intervention groups were performed using chi-square tests for categorical data and analysis of variance for continuous variables. Willingness were compared across the groups over time using mixed-effect logistic regressions for dichotomous outcomes.||||<0.05
73837892|NCT02933151|147224552|SUPERIORITY||Cox Proportional Hazard|1.03|||||TWO_SIDED|95.0|0.92|1.14|||||Reference group is usual care|||1.14|0.92|
73837893|NCT03400787|147224558|SUPERIORITY|||||||0.0001||||||p\<0.025 indicates statistical significance.|t-test, 1 sided|||Null hypothesis is that the responder rate for the Latera implant treatment was not superior to the sham treatment. A maximum sample size of 124 evaluable subjects is required for 90% power and preserving a 2.5% (one-sided) type I error rate.||||0.0001
73837894|NCT01644331|147224604|SUPERIORITY_OR_OTHER|||||||0.315|||||||Chi-squared|||||||0.315
73837895|NCT01644331|147224605|SUPERIORITY_OR_OTHER||Slope|0.19||||0.021|TWO_SIDED|95.0|0.03|0.34|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.34|0.03|0.021
73837896|NCT01644331|147224606|SUPERIORITY_OR_OTHER||Slope|0.99||||0.43|TWO_SIDED|95.0|-1.47|3.44|||Mixed Models Analysis|||This a repeated measure analysis so all rows (visits) are taken into account.||3.44|-1.47|0.430
73837897|NCT01644331|147224607|SUPERIORITY_OR_OTHER||Slope|-493.21||||0.157|TWO_SIDED|95.0|-1176.96|190.55|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||190.55|-1176.96|0.157
73837898|NCT01644331|147224608|SUPERIORITY_OR_OTHER|||||||0.206|||||||Chi-squared|||This is a repeated measures analysis so all rows (visits) are taken into account.||||0.206
73837899|NCT01644331|147224609|SUPERIORITY_OR_OTHER||Kaplan Meier|0.98||||0.334|TWO_SIDED|95.0|0.96|0.99|||Log Rank|||||0.99|0.96|0.334
73837900|NCT01644331|147224610|SUPERIORITY_OR_OTHER|||||||0.148|||||||Chi-squared|||||||0.148
73837901|NCT01644331|147224611|SUPERIORITY_OR_OTHER|||||||0.334|||||||Chi-squared|||||||0.334
73837902|NCT01644331|147224612|SUPERIORITY_OR_OTHER||Slope|-0.67||||0.241|TWO_SIDED|95.0|-1.79|0.45|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.45|-1.79|0.241
73837903|NCT01644331|147224613|SUPERIORITY_OR_OTHER||Slope|0.28||||0.303|TWO_SIDED|95.0|-0.26|0.82|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.82|-0.26|0.303
73837904|NCT01644331|147224614|SUPERIORITY_OR_OTHER|||||||0.471||||||24 hours|Chi-squared|||||||0.471
73837905|NCT01644331|147224614|SUPERIORITY_OR_OTHER|||||||0.585||||||48 hrs|Chi-squared|||||||0.585
73837906|NCT01644331|147224614|SUPERIORITY_OR_OTHER|||||||0.12||||||72 hrs|Chi-squared|||||||0.120
73837907|NCT01644331|147224615|SUPERIORITY_OR_OTHER|||||||0.037|||||||Chi-squared|||||||0.037
73837908|NCT01644331|147224616|SUPERIORITY_OR_OTHER|||||||0.373|||||||Wilcoxon (Mann-Whitney)|||||||0.373
73837909|NCT01644331|147224617|SUPERIORITY_OR_OTHER||Kaplan Meier|0.26||||0.709|TWO_SIDED|95.0|0.21|0.32|||Log Rank|||||0.32|0.21|0.709
73837910|NCT02327143|147224620|SUPERIORITY_OR_OTHER||Ratio of geometric least squares|0.448|||||TWO_SIDED|90.0|0.395|0.508|||||Absolute bioavailability of LY2835219 following the administration of 200 mg LY2835219 (oral) with 0.4 mg \[13C8\]-LY2835219 (IV).|||0.508|0.395|
73837911|NCT02070380|147224624|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|47.6|||<|0.0001|TWO_SIDED|95.0|34.5|60.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment."||60.7|34.5|<0.0001
73837912|NCT02070380|147224624|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|7.3||||0.1295|TWO_SIDED|95.0|-2.0|16.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||16.5|-2.0|0.1295
73837913|NCT02070380|147224624|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|79.0|||<|0.0001|TWO_SIDED|95.0|67.1|91.0||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment"||91.0|67.1|<0.0001
73837914|NCT02070380|147224624|SUPERIORITY_OR_OTHER||Percentage MH better minus DM better|-2.1||||0.7503|TWO_SIDED|95.0|-15.0|10.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||10.7|-15.0|0.7503
73837915|NCT02070380|147224624|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|66.1|||<|0.0001|TWO_SIDED|95.0|52.8|79.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment"||79.5|52.8|<0.0001
73837916|NCT02070380|147224624|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|-2.1||||0.7297|TWO_SIDED|95.0|-13.8|9.6||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||9.6|-13.8|0.7297
73837917|NCT02070380|147224625|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
73837918|NCT02070380|147224625|SUPERIORITY_OR_OTHER|||||||0.8238||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus post-dose paired global assessment."||||0.8238
73837919|NCT02070380|147224625|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
73837920|NCT02070380|147224625|SUPERIORITY_OR_OTHER|||||||0.4597||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||0.4597
73837921|NCT02070380|147224625|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
73837922|NCT02070380|147224625|SUPERIORITY_OR_OTHER|||||||0.8145||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||0.8145
73837923|NCT02070380|147224626|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.0020
73837924|NCT02070380|147224626|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
73837925|NCT02070380|147224626|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.0001
73837926|NCT02070380|147224626|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||1.0000
73837927|NCT02070380|147224626|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
73837928|NCT02070380|147224626|SUPERIORITY_OR_OTHER|||||||0.5811|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.5811
73837929|NCT02070380|147224627|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
73837930|NCT02070380|147224627|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
73837931|NCT02070380|147224627|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
73837932|NCT02070380|147224627|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||1.0000
73837933|NCT02070380|147224627|SUPERIORITY_OR_OTHER|||||||0.0023|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||0.0023
73837934|NCT02070380|147224627|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||1.0000
73837935|NCT02070380|147224628|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
73837936|NCT02070380|147224628|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
73837937|NCT02070380|147224628|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
73837938|NCT02070380|147224628|SUPERIORITY_OR_OTHER|||||||0.7503|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||0.7503
73837939|NCT02070380|147224628|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
73837940|NCT02070380|147224628|SUPERIORITY_OR_OTHER|||||||0.5983|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.05 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||0.5983
73837941|NCT02070380|147224629|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||<0.0001
73837942|NCT02070380|147224629|SUPERIORITY_OR_OTHER|||||||0.6898|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.6898
73837943|NCT02070380|147224629|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect.||||||<0.0001
73837944|NCT02070380|147224629|SUPERIORITY_OR_OTHER|||||||0.1156|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.1156
73837945|NCT02070380|147224629|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73837946|NCT02070380|147224629|SUPERIORITY_OR_OTHER|||||||0.7726|||||||Mixed Models Analysis|||||||0.7726
73837947|NCT02070380|147224630|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.0002
73837948|NCT02070380|147224630|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
73837949|NCT02070380|147224630|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
73837950|NCT02070380|147224630|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
73837951|NCT02070380|147224630|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
73837952|NCT02070380|147224630|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.0003
73837953|NCT03850431|147224631|OTHER||Odds Ratio (OR)|1.139||||0.145|TWO_SIDED|95.0|0.956|1.357|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.357|0.956|0.145
73837954|NCT03850431|147224631|OTHER||Odds Ratio (OR)|1.11||||0.298|TWO_SIDED|95.0|0.912|1.35|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.35|0.912|0.298
73837955|NCT03850431|147224631|OTHER||Odds Ratio (OR)|1.178||||0.127|TWO_SIDED|95.0|0.955|1.452|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.452|0.955|0.127
73837956|NCT03850431|147224631|OTHER||Odds Ratio (OR)|1.117||||0.286|TWO_SIDED|95.0|0.911|1.37|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.37|0.911|0.286
73837957|NCT03850431|147224631|OTHER||Odds Ratio (OR)|1.179||||0.183|TWO_SIDED|95.0|0.925|1.504|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.504|0.925|0.183
73837958|NCT03850431|147224631|OTHER||Odds Ratio (OR)|1.2||||0.209|TWO_SIDED|95.0|0.903|1.595|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.595|0.903|0.209
73837959|NCT03850431|147224631|OTHER||Odds Ratio (OR)|1.144||||0.463|TWO_SIDED|95.0|0.799|1.638|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.638|0.799|0.463
73837960|NCT03850431|147224631|OTHER||Odds Ratio (OR)|1.331||||0.074|TWO_SIDED|95.0|0.972|1.822|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.822|0.972|0.074
73837961|NCT03850431|147224631|OTHER||Odds Ratio (OR)|1.169||||0.306|TWO_SIDED|95.0|0.867|1.577|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.577|0.867|0.306
73837962|NCT03850431|147224631|OTHER||Odds Ratio (OR)|1.15||||0.373|TWO_SIDED|95.0|0.845|1.565|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.565|0.845|0.373
73837963|NCT03850431|147224632|OTHER||Odds Ratio (OR)|0.923||||0.153|TWO_SIDED|95.0|0.826|1.03|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.03|0.826|0.153
73837964|NCT03850431|147224632|OTHER||Odds Ratio (OR)|0.911||||0.252|TWO_SIDED|95.0|0.777|1.068|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.068|0.777|0.252
73837965|NCT03850431|147224632|OTHER||Odds Ratio (OR)|0.941||||0.413|TWO_SIDED|95.0|0.815|1.088|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.088|0.815|0.413
73837966|NCT03850431|147224632|OTHER||Odds Ratio (OR)|0.946||||0.41|TWO_SIDED|95.0|0.83|1.079|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.079|0.83|0.41
73837967|NCT03850431|147224632|OTHER||Odds Ratio (OR)|0.887||||0.11|TWO_SIDED|95.0|0.766|1.027|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.027|0.766|0.11
73837968|NCT03850431|147224632|OTHER||Odds Ratio (OR)|0.833||||0.14|TWO_SIDED|95.0|0.654|1.062|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.062|0.654|0.14
73837969|NCT03850431|147224632|OTHER||Odds Ratio (OR)|0.882||||0.404|TWO_SIDED|95.0|0.657|1.184|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.184|0.657|0.404
73837970|NCT03850431|147224632|OTHER||Odds Ratio (OR)|0.743||||0.072|TWO_SIDED|95.0|0.538|1.027|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.027|0.538|0.072
73837971|NCT03850431|147224632|OTHER||Odds Ratio (OR)|0.778||||0.057|TWO_SIDED|95.0|0.6|1.008|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.008|0.6|0.057
73837972|NCT03850431|147224632|OTHER||Odds Ratio (OR)|0.932||||0.637|TWO_SIDED|95.0|0.697|1.247|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.247|0.697|0.637
73837973|NCT01104870|147224702|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||Primary comparisons are between Dose Group 1 \& Dose Group 3 and Dose Group 1 \& Dose Group 2. The study is not powered to test for a difference between Dose Group 2 \& Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.||||0.95
73837974|NCT01104870|147224702|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|||||Primary comparisons are between Dose Group 1 \& Dose Group 3 and Dose Group 1 \& Dose Group 2. The study is not powered to test for a difference between Dose Group 2 \& Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.||||0.27
73837975|NCT03093246|147224745|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
73837976|NCT03093246|147224746|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
73837977|NCT03093246|147224747|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
73837978|NCT04641975|147224751|SUPERIORITY||LS Mean difference|2.22|STANDARD_ERROR_OF_MEAN|1.34||0.121|TWO_SIDED|90.0|-0.15|4.59|||ANCOVA|||Analysis of Covariance (ANCOVA) was performed with change from baseline at week 12 Last Observation Carried Forward (LOCF) as response, treatment group, sex and geographical region as fixed effects and the mean number of micturitions per 24 hours at baseline as covariate.||4.59|-0.15|0.121
73837979|NCT04641975|147224752|SUPERIORITY||Mean Difference (Final Values)|-15.51|STANDARD_ERROR_OF_MEAN|18.91||0.43|TWO_SIDED|90.0|-49.47|18.46|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||18.46|-49.47|0.430
73837980|NCT04641975|147224752|SUPERIORITY||Mean Difference (Final Values)|-15.51|STANDARD_ERROR_OF_MEAN|18.91||0.43|TWO_SIDED|90.0|-49.47|18.46|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||18.46|-49.47|0.430
73837981|NCT04641975|147224753|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|31.08||0.935|TWO_SIDED|90.0|-53.23|58.38|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||58.38|-53.23|0.935
73898410|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|0.33|STANDARD_ERROR_OF_MEAN|0.657||0.615|TWO_SIDED|95.0|-0.962|1.624||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 96||1.624|-0.962|0.615
73837982|NCT04641975|147224753|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|31.08||0.935|TWO_SIDED|90.0|-53.23|58.38|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||58.38|-53.23|0.935
73837983|NCT04641975|147224754|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.53||0.073|TWO_SIDED|90.0|-1.99|-0.1|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||-0.10|-1.99|0.073
73837984|NCT04641975|147224754|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.45||0.044|TWO_SIDED|90.0|-1.8|-0.2|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||-0.20|-1.80|0.044
73898411|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.61|||TWO_SIDED|||||||||Week 96||||
73837985|NCT04641975|147224755|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.91|TWO_SIDED|90.0|-0.74|0.64|||ANCOVA|||ANCOVA as performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime incontinence episodes per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||0.64|-0.74|0.910
73837986|NCT04641975|147224755|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.91|TWO_SIDED|90.0|-0.74|0.64|||ANCOVA|||ANCOVA as performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime incontinence episodes per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||0.64|-0.74|0.910
73837987|NCT04641975|147224756|SUPERIORITY||Mean Difference (Final Values)|2.48|STANDARD_ERROR_OF_MEAN|0.85||0.012|TWO_SIDED|90.0|0.97|3.99|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime micturitions per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||3.99|0.97|0.012
73837988|NCT04641975|147224756|SUPERIORITY||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|0.77||0.007|TWO_SIDED|90.0|1.1|3.82|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime micturitions per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||3.82|1.10|0.007
73837989|NCT04641975|147224757|SUPERIORITY||Rate ratio|0.2||||0.105|TWO_SIDED|90.0|0.04|1.02|||Binomial regression|||Without LOCF: From a negative binomial regression model including treatment group, sex and region as factors and the log baseline rate of number of dry days (the log of the ratio of dry days at baseline and number of diary days at baseline) as covariate.||1.02|0.04|0.105
73837990|NCT04641975|147224757|SUPERIORITY||Rate ratio|0.22||||0.111|TWO_SIDED|90.0|0.05|1.05|||Binomial regression|||With LOCF: From a negative binomial regression model including treatment group, sex and region as factors and the log baseline rate of number of dry days (the log of the ratio of dry days at baseline and number of diary days at baseline) as covariate.||1.05|0.05|0.111
73837991|NCT01657500|147224776|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|See above|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Main outcome measure was endothelial cell loss at 6 months after EK. Sample size and statistical power calculations for testing equivalence of means within 10% range were performed at 80% power/0.025 level of significance. 20% variability was assumed. 6-month endothelial cell loss) should not differ significantly for surgeon-prepared versus eye bank-prepared tissue. Assuming pairs of corneas matched by pt. diagnosis and other characteristics, the required sample size was 34 donor pairs.||||< 0.05
73837992|NCT00449007|147224843|SUPERIORITY||Mean Difference (Final Values)|4.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Difference between 6 months and baseline for Bupropion treated group.~Due to the low number of participants, the results are unreliable."||||1.0
73837993|NCT02777190|147224869|NON_INFERIORITY|Margin of 4 hours|Mean Difference (Final Values)|-1.7||||0.09|ONE_SIDED|97.5||6.7|||t-test, 1 sided|one-sided two-sample t-test with alpha=0.025|Difference calculated as oral minus vaginal|||6.7||0.09
73837994|NCT02777190|147224870|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
73837995|NCT02777190|147224871|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
73837996|NCT02777190|147224872|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
73898412|NCT02880956|147328891|SUPERIORITY||LS Mean of Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.678||0.637|TWO_SIDED|95.0|-1.653|1.014||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.014|-1.653|0.637
73898413|NCT02880956|147328891|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|4.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73837997|NCT02777190|147224873|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
73837998|NCT02777190|147224874|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73837999|NCT02777190|147224875|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.60
73838000|NCT02777190|147224877|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.40
73838001|NCT02777190|147224878|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73838002|NCT02777190|147224879|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
73838003|NCT02777190|147224880|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73838004|NCT02777190|147224881|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
73838005|NCT01452789|147224882|SUPERIORITY||||||<|0.05|||||||van Elteren|||||||<0.05
73838006|NCT01452789|147224883|SUPERIORITY||||||<|0.05|||||||van Elteren|||||||<0.05
73838007|NCT01452789|147224884|SUPERIORITY||||||<|0.05|||||||Cochran-Mantel-Haenszel|||||||<0.05
73838008|NCT00066170|147224900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's|||||||<0.001
73838009|NCT00066170|147224900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's|||||||<0.001
73838010|NCT00098293|147224901|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\>) -10%.|Difference in Percentage|-3.0|||||ONE_SIDED|97.5|-9.5|||||||Less than 400 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% confidence interval (CI) based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-9.5|
73838011|NCT00098293|147224901|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.2|||||ONE_SIDED|97.5|-10.9|||||||Less than 50 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.9|
73838012|NCT00098293|147224902|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.1|||||ONE_SIDED|97.5|-10.5|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.5|
73838013|NCT00098293|147224902|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.4|||||ONE_SIDED|97.5|-11.2|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-11.2|
73838014|NCT00098293|147224903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.4485|TWO_SIDED|95.0|0.64|1.22|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates was used. Odds ratio \> 1 would favor maraviroc.||1.22|0.64|0.4485
73838015|NCT00098293|147224903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.2724|TWO_SIDED|95.0|0.61|1.15|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.15|0.61|0.2724
73838016|NCT00098293|147224904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.3943|TWO_SIDED|95.0|0.65|1.19|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.19|0.65|0.3943
73838017|NCT00098293|147224904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.1289|TWO_SIDED|95.0|0.59|1.07|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.07|0.59|0.1289
73838018|NCT00098293|147224905|SUPERIORITY_OR_OTHER||LS Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.1077||0.2741|TWO_SIDED|95.0|-0.094|0.329|||ANCOVA|||Change at week 48: P-value was calculated using Analysis of Covariance (ANCOVA) with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment least squares means (LS means) adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.329|-0.094|0.2741
73838019|NCT00098293|147224905|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1162||0.3899|TWO_SIDED|95.0|-0.128|0.328|||ANCOVA|||Change at week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.328|-0.128|0.3899
73838020|NCT00098293|147224906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.111|STANDARD_ERROR_OF_MEAN|0.1002||0.2693|TWO_SIDED|95.0|-0.086|0.307|||ANCOVA|||Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.307|-0.086|0.2693
73863163|NCT05065190|147272359|OTHER||Adjusted difference|106.57|STANDARD_ERROR_OF_MEAN|76.84|||TWO_SIDED|95.0|-47.13|260.28|||||Adjusted difference between treatment groups was based on a random slope and intercept model with fixed effects for treatment, HRCT pattern, and baseline FVC \[mL\], and including treatment-by-time and baseline-by-time interactions.|||260.28|-47.13|
73970964|NCT05139810|147481974|SUPERIORITY||IC HAE attack rate ratio|0.13|||<|0.001|TWO_SIDED|95.0|0.062|0.281|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.281|0.062|<0.001
73838021|NCT00098293|147224906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.089|STANDARD_ERROR_OF_MEAN|0.1121||0.427|TWO_SIDED|95.0|-0.131|0.309|||ANCOVA|||Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.309|-0.131|0.4270
73838022|NCT00098293|147224907|SUPERIORITY_OR_OTHER||LS Mean Difference|26.34|STANDARD_ERROR_OF_MEAN|9.827||0.0075|TWO_SIDED|95.0|7.04|45.63|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||45.63|7.04|0.0075
73838023|NCT00098293|147224907|SUPERIORITY_OR_OTHER||LS Mean Difference|35.44|STANDARD_ERROR_OF_MEAN|11.419||0.002|TWO_SIDED|95.0|13.02|57.86|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||57.86|13.02|0.0020
73838024|NCT00098293|147224908|SUPERIORITY_OR_OTHER||LS Mean Difference|166.29|STANDARD_ERROR_OF_MEAN|25.04|<|0.0001|TWO_SIDED|95.0|117.13|215.46|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||215.46|117.13|<0.0001
73838025|NCT00098293|147224908|SUPERIORITY_OR_OTHER||LS Mean Difference|172.22|STANDARD_ERROR_OF_MEAN|25.471|<|0.0001|TWO_SIDED|95.0|122.21|222.23|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||222.23|122.21|<0.0001
73838026|NCT00098293|147224909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.5874|TWO_SIDED|95.0|0.83|1.45|||Log Rank|||Week 48: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \< 1 would favor maraviroc.||1.45|0.83|0.5874
73838027|NCT00098293|147224909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.4811|TWO_SIDED|95.0|0.86|1.4|||Log Rank|||Week 96: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \< 1 would favor maraviroc.||1.40|0.86|0.4811
73838028|NCT00098293|147224916|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\>) -10%.|Difference in Percentage|-3.2|||||ONE_SIDED|97.5|-10.2|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.2|
73838029|NCT00098293|147224916|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-5.8|||||ONE_SIDED|97.5|-12.8|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-12.8|
73838030|NCT00098293|147224917|SUPERIORITY_OR_OTHER||Difference in Percentage|0.6|||||ONE_SIDED|97.5|-6.4|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-6.4|
73838031|NCT00098293|147224917|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||ONE_SIDED|97.5|-7.4|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-7.4|
73838032|NCT00098293|147224918|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4|||||ONE_SIDED|97.5|-7.9|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-7.9|
73838033|NCT00098293|147224918|SUPERIORITY_OR_OTHER||Difference in Percentage|-3.9|||||ONE_SIDED|97.5|-11.5|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-11.5|
73863164|NCT01073930|147272411|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was \>-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was \>0%.|Mean Difference (Net)|9.8|||||ONE_SIDED|97.5|3.4||||||||||3.4|
73838034|NCT01370642|147224919|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|29.0|||<|0.001|TWO_SIDED|95.0|17.2|40.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by Interleukin 28B (IL28B) and age utilizing Cochran-Mantel-Haenszel weights.||40.5|17.2|<0.001
73838035|NCT01370642|147224919|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|28.6|||<|0.001|TWO_SIDED|95.0|17.4|40.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||40.0|17.4|<0.001
73970965|NCT05139810|147481974|SUPERIORITY||IC HAE attack rate ratio|0.4|||=|0.004|TWO_SIDED|95.0|0.212|0.748|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.748|0.212|=0.004
73838036|NCT01370642|147224920|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|30.0|||<|0.001|TWO_SIDED|95.0|18.1|41.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||41.5|18.1|<0.001
73838037|NCT01370642|147224920|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|29.6|||<|0.001|TWO_SIDED|95.0|18.3|41.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||41.0|18.3|<0.001
73838038|NCT01370642|147224921|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|78.1|||<|0.001|TWO_SIDED|95.0|68.2|85.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||85.3|68.2|<0.001
73838039|NCT01370642|147224921|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|76.7|||<|0.001|TWO_SIDED|95.0|66.7|84.1|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||84.1|66.7|<0.001
73838040|NCT01370642|147224922|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|48.4|||<|0.001|TWO_SIDED|95.0|37.2|58.9|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||58.9|37.2|<0.001
73838041|NCT01370642|147224922|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|49.6|||<|0.001|TWO_SIDED|95.0|38.5|60.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||60.0|38.5|<0.001
73838042|NCT01370642|147224923|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|17.0|||<|0.001|TWO_SIDED|95.0|8.1|27.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||27.3|8.1|<0.001
73838043|NCT01370642|147224923|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|17.8|||<|0.001|TWO_SIDED|95.0|9.3|27.8|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||27.8|9.3|<0.001
73838044|NCT01370642|147224924|SUPERIORITY_OR_OTHER||Difference in percentages|4.1||||0.385|TWO_SIDED|95.0|-5.4|13.7|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.||13.7|-5.4|0.385
73838045|NCT01370642|147224924|SUPERIORITY_OR_OTHER||Difference in percentages|-2.2||||0.67|TWO_SIDED|95.0|-12.6|8.1|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.||8.1|-12.6|0.670
73838046|NCT01370642|147224924|SUPERIORITY_OR_OTHER||Difference in percentages|-4.1||||0.557|TWO_SIDED|95.0|-17.5|9.5|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.||9.5|-17.5|0.557
73838047|NCT01370642|147224924|SUPERIORITY_OR_OTHER||Difference in percentages|-12.7||||0.072|TWO_SIDED|95.0|-26.2|1.2|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.||1.2|-26.2|0.072
73838048|NCT01370642|147224924|SUPERIORITY_OR_OTHER||Difference in percentages|0.0|||>|0.999|TWO_SIDED|95.0|-7.9|7.9|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.||7.9|-7.9|>0.999
73838049|NCT01370642|147224924|SUPERIORITY_OR_OTHER||Difference in percentages|5.2||||0.22|TWO_SIDED|95.0|-3.3|14.2|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.||14.2|-3.3|0.220
73838050|NCT01370642|147224924|SUPERIORITY_OR_OTHER||Difference in percentages|15.3||||0.032|TWO_SIDED|95.0|1.3|28.7|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.||28.7|1.3|0.032
73838051|NCT01370642|147224924|SUPERIORITY_OR_OTHER||Difference in percentages|5.6||||0.432|TWO_SIDED|95.0|-8.4|19.4|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.||19.4|-8.4|0.432
73838052|NCT01370642|147224924|SUPERIORITY_OR_OTHER||Difference in percentages|8.2||||0.252|TWO_SIDED|95.0|-5.8|21.8|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.||21.8|-5.8|0.252
73838053|NCT01370642|147224924|SUPERIORITY_OR_OTHER||Difference in percentages|0.5||||0.942|TWO_SIDED|95.0|-13.4|14.4|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.||14.4|-13.4|0.942
73838054|NCT01370642|147224925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 2|-3.2|||||TWO_SIDED|95.0|-3.5|-3.0|||Constrained LDA Model|||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-3.0|-3.5|
73838055|NCT01370642|147224925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 2|-3.5|||||TWO_SIDED|95.0|-3.7|-3.2|||Constrained LDA Model|||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-3.2|-3.7|
73898414|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.367||0.261|TWO_SIDED|95.0|-1.135|0.308||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.308|-1.135|0.261
73838056|NCT01370642|147224925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 4|-3.0|||||TWO_SIDED|95.0|-3.3|-2.7|||Constrained LDA Model|||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-2.7|-3.3|
73838057|NCT01370642|147224925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 4|-3.1|||||TWO_SIDED|95.0|-3.4|-2.8|||Constrained LDA Model|||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-2.8|-3.4|
73898415|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73838058|NCT01370642|147224925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 8|-1.9|||||TWO_SIDED|95.0|-2.2|-1.6|||Constrained LDA Model|||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.6|-2.2|
73898416|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|0.29|STANDARD_ERROR_OF_MEAN|0.361||0.423|TWO_SIDED|95.0|-0.42|1.001||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.001|-0.420|0.423
73838059|NCT01370642|147224925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 8|-2.0|||||TWO_SIDED|95.0|-2.3|-1.7|||Constrained LDA Model|||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.7|-2.3|
73898417|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898418|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.371||0.322|TWO_SIDED|95.0|-1.097|0.361||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.361|-1.097|0.322
73898419|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|2.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898420|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.397||0.498|TWO_SIDED|95.0|-0.511|1.049||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.049|-0.511|0.498
73898421|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|3.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898422|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|0.75|STANDARD_ERROR_OF_MEAN|0.386||0.052|TWO_SIDED|95.0|-0.006|1.51||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.510|-0.006|0.052
73898423|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|3.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898424|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.398||0.597|TWO_SIDED|95.0|-0.993|0.572||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.572|-0.993|0.597
73898425|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898426|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.376||0.896|TWO_SIDED|95.0|-0.689|0.788||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.788|-0.689|0.896
73898427|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|3.4|||TWO_SIDED|||||||||Week 72||||
73898428|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|0.53|STANDARD_ERROR_OF_MEAN|0.369||0.149|TWO_SIDED|95.0|-0.192|1.258||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.258|-0.192|0.149
73898429|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898430|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.376||0.522|TWO_SIDED|95.0|-0.98|0.499||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.499|-0.980|0.522
73898431|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|2.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898432|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.424||0.528|TWO_SIDED|95.0|-1.103|0.567||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.567|-1.103|0.528
73898433|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|3.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898434|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|0.3|STANDARD_ERROR_OF_MEAN|0.416||0.474|TWO_SIDED|95.0|-0.519|1.116||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.116|-0.519|0.474
73898435|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898436|NCT02880956|147328892|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.429||0.441|TWO_SIDED|95.0|-1.176|0.513||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.513|-1.176|0.441
73838060|NCT01370642|147224925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 12|-1.4|||||TWO_SIDED|95.0|-1.7|-1.1|||Constrained LDA Model|||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.1|-1.7|
73838061|NCT01370642|147224925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 12|-1.4|||||TWO_SIDED|95.0|-1.7|-1.1|||Constrained LDA Model|||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.1|-1.7|
73838062|NCT01370642|147224925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 24|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5|||Constrained LDA Model|||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-0.5|-1.1|
73838063|NCT01370642|147224925|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 24|-0.9|||||TWO_SIDED|95.0|-1.2|-0.6|||Constrained LDA Model|||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-0.6|-1.2|
73838064|NCT01927861|147224934|OTHER||Treatment difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.38|0.88|||ANCOVA|||The change from baseline (week 0) in the height SDS after 104 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline height SDS as a covariate.||0.88|0.38|< 0.0001
73838065|NCT00987935|147225002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.357|||||TWO_SIDED|95.0|0.802|2.296|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.296|0.802|
73838066|NCT00987935|147225003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213|||||TWO_SIDED|95.0|0.73|2.014|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.014|0.730|
73838067|NCT00987935|147225007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.186|||||TWO_SIDED|95.0|0.728|1.932|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.932|0.728|
73838068|NCT00987935|147225008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.593|1.489|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.489|0.593|
73838069|NCT02057666|147225090|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.406||||0.027|TWO_SIDED|95.0|0.182|0.903|||Log Rank|Stratified as per randomisation.|Stratified as per randomisation.|||0.903|0.182|0.027
73838070|NCT02057666|147225091|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.465||||0.448|TWO_SIDED|95.0|0.065|3.355|||Log Rank|||||3.355|0.065|0.448
73838071|NCT00066937|147225097|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline to each timepoint||||||<.05
73838072|NCT00066937|147225098|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
73838073|NCT00066937|147225099|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
73838074|NCT00066937|147225100|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
73838075|NCT01793129|147225120|SUPERIORITY|This trial estimated the probability that the intervention has no effect on the outcome (or conversely, the probability that id does), given the data obtained in the trial and any prior evidence.|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.74|2.0|||||The relative risk estimate was calculated by dividing risk under hypothermia by risk under normothermia.|Whole-body Hypothermia vs. Normothermia (Normothermia is the comparison group)|To get estimates of RR from the Bayesian logistic regression model, predicted probabilities of the outcome were generated for all infants assuming the infants were treated with and without hypothermia and with/without severe encephalopathy. Next subject level RR values were estimated for all infants and 2.5, 50, and 97.5 percentiles were calculated.|2.00|0.74|
73838076|NCT01428713|147225130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|536.4|STANDARD_ERROR_OF_MEAN|162.12||0.01||||||P value \< 0.05 is considered significant in this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for TA|||||0.01
73838077|NCT01428713|147225130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|430.6|STANDARD_ERROR_OF_MEAN|157.35||0.03||||||P value \< 0.05 is considered significant for this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for COCP|||||0.03
73838078|NCT01428713|147225130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|STANDARD_ERROR_OF_MEAN|5.08||0.03||||||P value \< 0.05 is considered significant for this study|Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for TA|||||0.03
73838079|NCT01428713|147225130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.75|STANDARD_ERROR_OF_MEAN|4.87||0.01|||||||Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for COCP|||||0.01
73838080|NCT01052428|147225133|SUPERIORITY_OR_OTHER|||||||0.4568||95.0|||||Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.4568
73898437|NCT02880956|147328892|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|3.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73959486|NCT04001517|147454591|SUPERIORITY||Mean Difference (Net)|0.175||||0.049|TWO_SIDED|95.0|0.001|0.345||The comparison is of neflamapimod 40mg TID to placebo. The p-value was not adjusted for multiple comparisons.|Mixed Models Analysis||The comparison is of neflamapimod 40mg TID to placebo. The positive value represents a better outcome with neflamapimod 40mg treatment vs. placebo.|This was an exploratory trial and no explicit a priori hypothesis was established and contained in the protocol. As such, no formal power calculations were conducted. The primary objective of the study was to evaluate the effects of neflamapimod on cognition, and accordingly the primary endpoint was change in combined z-score of the six tests in the NTB, analyzed by Linear Mixed Effects (LME) model for repeated measures.||0.345|0.001|0.049
73959487|NCT04001517|147454591|SUPERIORITY|Comparison of combined neflamapimod groups vs. placebo.|||||>|0.2|||||||Mixed Models Analysis|||||||>0.2
73959488|NCT04001517|147454592|SUPERIORITY|Comparison of combined neflamapimod 40mg TID vs. placebo. The p-value is not adjusted for multiple comparisons.|Mean Difference (Net)|-0.56||||0.007|TWO_SIDED|95.0|-0.96|-0.16||Comparison of combined neflamapimod dose groups vs. placebo utilizing mixed model for repeated measures with baseline as a covariate. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis||The comparison is of neflamapimod 40mg TID to placebo. A negative value indicates improvement compared to placebo.|||-0.16|-0.96|0.007
73959489|NCT04001517|147454592|SUPERIORITY||Mean Difference (Net)|-0.45||||0.023|TWO_SIDED|95.0|-0.83|-0.06||Mixed model for repeated measures with baseline as a covariate. The p-value was not adjusted for multiple comparisons|Mixed Models Analysis||Comparison of combined neflamapimod dose groups vs. placebo. Negative values represents a better outcome with neflamapimod relative to placebo.|A secondary analysis was conducted comparing the combined neflamapimod dose groups vs. placebo.||-0.06|-0.83|0.023
73959490|NCT04001517|147454593|SUPERIORITY||||||>|0.2|||||||Mixed Models Analysis|||||||>0.2
73959491|NCT04001517|147454594|OTHER||Mean Difference (Net)|-1.53||||0.15|TWO_SIDED|95.0|-3.61|0.55|||Mixed Models Analysis|||||.55|-3.61|0.15
73959492|NCT04001517|147454594|SUPERIORITY||Mean Difference (Net)|-1.31||||0.077|TWO_SIDED|95.0|-5.03|2.34|||Mixed Models Analysis|||Comparison of combined neflamapimod groups (i.e., all neflamapimod) vs. placebo||2.34|-5.03|0.077
73959493|NCT04001517|147454595|SUPERIORITY||Mean Difference (Net)|0.32|||>|0.2|TWO_SIDED|95.0|-1.27|1.91|||Mixed Models Analysis||Comparison of change from baseline over course of study for NFMD 40mg TID vs. placebo.|||1.91|-1.27|>0.2
73959494|NCT04001517|147454596|OTHER||Mean Difference (Net)|-1.4||||0.024|TWO_SIDED|95.0|-2.6|-0.2|||Mixed Models Analysis||Mean difference for the comparison of 40 mg TID vs. placebo is reported.|||-0.2|-2.6|0.024
73959495|NCT04001517|147454596|SUPERIORITY|Comparison of combined neflamapimod dose groups vs. placebo.|Mean Difference (Net)|-1.36||||0.044|TWO_SIDED|95.0|-2.69|-0.04|||Mixed Models Analysis|||||-0.04|-2.69|0.044
73959496|NCT02194933|147454605|SUPERIORITY_OR_OTHER|||||||0.3992||||||Test for Baseline vs. Week 6|Mixed Models Analysis|||||||0.3992
73959497|NCT02194933|147454606|SUPERIORITY_OR_OTHER|||||||0.0053||||||Test for Baseline vs. Week 6|Mixed Models Analysis|||||||0.0053
73959498|NCT02194933|147454608|SUPERIORITY_OR_OTHER|||||||0.1559|||||||Mixed Models Analysis|||||||0.1559
73959499|NCT02194933|147454608|SUPERIORITY_OR_OTHER|||||||0.6201|||||||Mixed Models Analysis|||||||0.6201
73959500|NCT02194933|147454609|SUPERIORITY_OR_OTHER|||||||0.1642|||||||Mixed Models Analysis|||||||0.1642
73959501|NCT02194933|147454609|SUPERIORITY_OR_OTHER|||||||0.1873|||||||Mixed Models Analysis|||||||0.1873
73959502|NCT02194933|147454612|SUPERIORITY_OR_OTHER|||||||0.2061|||||||Mixed Models Analysis|||||||0.2061
73959503|NCT02194933|147454612|SUPERIORITY_OR_OTHER|||||||0.1778|||||||Mixed Models Analysis|||||||0.1778
73959504|NCT02194933|147454613|SUPERIORITY_OR_OTHER|||||||0.4138|||||||Mixed Models Analysis|||||||0.4138
73959505|NCT02194933|147454613|SUPERIORITY_OR_OTHER|||||||0.3375|||||||Mixed Models Analysis|||||||0.3375
73959506|NCT02194933|147454616|SUPERIORITY_OR_OTHER|||||||0.8437|||||||Mixed Models Analysis|||||||0.8437
73959507|NCT02194933|147454616|SUPERIORITY_OR_OTHER|||||||0.8318|||||||Mixed Models Analysis|||||||0.8318
73959508|NCT02194933|147454617|SUPERIORITY_OR_OTHER|||||||0.6697|||||||Mixed Models Analysis|||||||0.6697
73959509|NCT02194933|147454617|SUPERIORITY_OR_OTHER|||||||0.8829|||||||Mixed Models Analysis|||||||0.8829
73959510|NCT02194933|147454618|SUPERIORITY_OR_OTHER|||||||0.2301|||||||Mixed Models Analysis|||||||0.2301
73959511|NCT02194933|147454618|SUPERIORITY_OR_OTHER|||||||0.0599|||||||Mixed Models Analysis|||||||0.0599
73959512|NCT02194933|147454619|SUPERIORITY_OR_OTHER|||||||0.1595|||||||Mixed Models Analysis|||||||0.1595
73959513|NCT02194933|147454619|SUPERIORITY_OR_OTHER|||||||0.1211|||||||Mixed Models Analysis|||||||0.1211
73959514|NCT02194933|147454620|SUPERIORITY_OR_OTHER|||||||0.1322|||||||Mixed Models Analysis|||||||0.1322
73959515|NCT02194933|147454620|SUPERIORITY_OR_OTHER|||||||0.2113|||||||Mixed Models Analysis|||||||0.2113
73959516|NCT02194933|147454621|SUPERIORITY_OR_OTHER|||||||0.0578|||||||Mixed Models Analysis|||||||0.0578
73959517|NCT02194933|147454621|SUPERIORITY_OR_OTHER|||||||0.0588|||||||Mixed Models Analysis|||||||0.0588
73959518|NCT02194933|147454622|SUPERIORITY_OR_OTHER|||||||0.1666|||||||Mixed Models Analysis|||||||0.1666
73959519|NCT02194933|147454622|SUPERIORITY_OR_OTHER|||||||0.767|||||||Mixed Models Analysis|||||||0.7670
73959520|NCT02194933|147454623|SUPERIORITY_OR_OTHER|||||||0.7178|||||||Mixed Models Analysis|||||||0.7178
73959521|NCT02194933|147454623|SUPERIORITY_OR_OTHER|||||||0.2336|||||||Mixed Models Analysis|||||||0.2336
73959522|NCT02194933|147454624|SUPERIORITY_OR_OTHER|||||||0.6558|||||||Mixed Models Analysis|||||||0.6558
73959523|NCT02194933|147454624|SUPERIORITY_OR_OTHER|||||||0.9058|||||||Mixed Models Analysis|||||||0.9058
73959524|NCT02194933|147454625|SUPERIORITY_OR_OTHER|||||||0.0078|||||||Mixed Models Analysis|||||||0.0078
73959525|NCT02194933|147454625|SUPERIORITY_OR_OTHER|||||||0.4272|||||||Mixed Models Analysis|||||||0.4272
73959526|NCT02914522|147454629|SUPERIORITY||Difference in Percentages|10.8||||0.0157|TWO_SIDED|95.0|2.1|19.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and immunomodulators (Yes/No) at Day 1.||||19.5|2.1|0.0157
73959527|NCT02914522|147454629|SUPERIORITY||Difference in Percentages|3.8||||0.3379|TWO_SIDED|95.0|-4.3|12.0|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||12.0|-4.3|0.3379
73838081|NCT01052428|147225134|SUPERIORITY_OR_OTHER|||||||0.1967||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.1967
73898438|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.331||0.027|TWO_SIDED|95.0|-1.383|-0.082||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.082|-1.383|0.027
73898439|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|-0.26|STANDARD_DEVIATION|2.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73959528|NCT02914522|147454629|SUPERIORITY||Difference in Percentages|7.2||||0.0103|TWO_SIDED|95.0|1.6|12.8|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||12.8|1.6|0.0103
73898440|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.328||0.146|TWO_SIDED|95.0|-1.123|0.167||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.167|-1.123|0.146
74083766|NCT00550147|147720578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|STANDARD_ERROR_OF_MEAN|1.39|<|0.05|TWO_SIDED|95.0|-7.04|-1.29|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-1.29|-7.04|<0.05
74083767|NCT00550147|147720579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|2.16|<|0.05||95.0|-17.76|-8.82|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-8.82|-17.76|<0.05
74083768|NCT02616380|147720604|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
74083769|NCT02616380|147720605|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12||||<0.0001
74083770|NCT02616380|147720605|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24||||<0.0001
74083771|NCT02616380|147720605|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12||||<0.0001
74083772|NCT02616380|147720605|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24||||<0.0001
74083773|NCT02616380|147720606|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks||||<0.0001
74083774|NCT02616380|147720606|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks||||<0.0001
74083775|NCT02616380|147720607|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12||||<0.0001
73959529|NCT02914522|147454629|SUPERIORITY||Difference in Percentages|5.2||||0.0645|TWO_SIDED|95.0|0.0|10.5|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||10.5|-0.0|0.0645
74083776|NCT02616380|147720607|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24||||<0.0001
74083777|NCT02616380|147720607|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12||||<0.0001
74083778|NCT02616380|147720607|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24||||<0.0001
74083779|NCT02616380|147720608|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
74083780|NCT03407729|147720615|OTHER|Using seed-based analysis with a 1) Left Thalamus seed and 2) Left Middle Temporal Gyrus seed, cluster size was set at 50 voxels and p-value was thresholded at p\<0.05. This was used to compare the differences between the two study groups in terms of number of activated voxels during during cognitive testing using the N-back.|||||<|0.05||||||The a priori threshold for statistical significance was p\<0.05 and statistical power was set at a minimum of 0.80.|t-test, 2 sided|||||||<0.05
74083781|NCT03950674|147720617|OTHER||Hazard Ratio (HR)|0.62||||0.12511|TWO_SIDED|95.0|0.27|1.42||One-sided p-value based on unstratified log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||1.42|0.27|0.12511
74083782|NCT03950674|147720618|OTHER||Hazard Ratio (HR)|0.29||||0.03127|TWO_SIDED|95.0|0.07|1.15||One-sided p-value based on unstratified log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||1.15|0.07|0.03127
74083783|NCT02707276|147720633|SUPERIORITY||Mean Difference (Final Values)|-0.625|STANDARD_DEVIATION|12.0|<|0.76|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|mean raw change active-sham; pooled standard deviation|Repeated measures ANCOVA with baseline MADRS scores as covariate for treatment and order effects of difference in MADRS scores.||||<0.76
74083784|NCT02707276|147720633|SUPERIORITY||Mean Difference (Final Values)|-5.17|STANDARD_DEVIATION|4.96|<|0.33|TWO_SIDED||||||ANCOVA|Baseline covariate|Pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.33
74083785|NCT02707276|147720634|SUPERIORITY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|9.1|<|0.61|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|raw change active-sham mean; pooled standard deviation|Repeated measures ANCOVA with baseline HARS scores as covariate for treatment and order effects of difference in HARS scores.||||<0.61
74083786|NCT02707276|147720634|SUPERIORITY||Mean Difference (Final Values)|-4.33|STANDARD_DEVIATION|4.0|<|0.32|TWO_SIDED||||||ANCOVA|baseline as covariate|pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.32
74083787|NCT02707276|147720635|SUPERIORITY||Mean Difference (Final Values)|-1.625|STANDARD_DEVIATION|10.2|<|0.78|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|raw active-sham mean; pooled standard deviation|Repeated measures ANCOVA with baseline PANAS (Positive sub scale) scores as covariate for treatment and order effects of difference in PANAS (Positive sub scale) scores.||||<0.78
74083788|NCT02707276|147720635|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|2.42|<|0.99|TWO_SIDED||||||ANCOVA|baseline as covariate|pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.99
73959530|NCT02914522|147454630|SUPERIORITY||Difference in Percentages|26.0|||<|0.0001|TWO_SIDED|95.0|16.0|35.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.9|16.0|< 0.0001
73959531|NCT02914522|147454630|SUPERIORITY||Difference in Percentages|10.4||||0.042|TWO_SIDED|95.0|0.0|20.7|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.7|-0.0|0.0420
73959532|NCT02914522|147454631|SUPERIORITY||Difference in Percentages|12.1||||0.0053|TWO_SIDED|95.0|3.8|20.4|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||20.4|3.8|0.0053
73959533|NCT02914522|147454631|SUPERIORITY||Difference in Percentages|4.6||||0.2295|TWO_SIDED|95.0|-3.1|12.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||12.2|-3.1|0.2295
73959534|NCT02914522|147454631|SUPERIORITY||Difference in Percentages|5.3||||0.0393|TWO_SIDED|95.0|-0.1|10.7|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||10.7|-0.1|0.0393
73959535|NCT02914522|147454631|SUPERIORITY||Difference in Percentages|1.7||||0.5308|TWO_SIDED|95.0|-3.1|6.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||6.6|-3.1|0.5308
73959536|NCT02914522|147454632|SUPERIORITY||Difference in Percentages|8.6||||0.0047|TWO_SIDED|95.0|2.9|14.3|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||14.3|2.9|0.0047
73959537|NCT02914522|147454632|SUPERIORITY||Difference in Percentages|2.1||||0.3495|TWO_SIDED|95.0|-2.6|6.8|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||6.8|-2.6|0.3495
73959538|NCT02914522|147454632|SUPERIORITY||Difference in Percentages|1.3||||0.4269|TWO_SIDED|95.0|-2.5|5.1|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||5.1|-2.5|0.4269
73959539|NCT02914522|147454632|SUPERIORITY||Difference in Percentages|0.0||||0.9987|TWO_SIDED|95.0|-3.4|3.4|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||3.4|-3.4|0.9987
73959540|NCT02914522|147454633|SUPERIORITY||Difference in Percentages|19.0|||<|0.0001|TWO_SIDED|95.0|9.9|28.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||28.2|9.9|<0.0001
73959541|NCT02914522|147454633|SUPERIORITY||Difference in Percentages|7.8||||0.0672|TWO_SIDED|95.0|-0.7|16.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||16.2|-0.7|0.0672
73959542|NCT02914522|147454633|SUPERIORITY||Difference in Percentages|11.4||||0.0019|TWO_SIDED|95.0|4.2|18.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||18.6|4.2|0.0019
73959543|NCT02914522|147454633|SUPERIORITY||Difference in Percentages|5.2||||0.1286|TWO_SIDED|95.0|-1.4|11.8|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||11.8|-1.4|0.1286
73959544|NCT02914522|147454634|SUPERIORITY||Difference in Percentages|7.9||||0.0105|TWO_SIDED|95.0|1.9|13.8|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1||||13.8|1.9|0.0105
73959545|NCT02914522|147454634|SUPERIORITY||Difference in Percentages|4.3||||0.1062|TWO_SIDED|95.0|-1.0|9.6|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1||||9.6|-1.0|0.1062
73898441|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|2.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73959546|NCT02914522|147454634|SUPERIORITY||Difference in Percentages|1.7||||0.3084|TWO_SIDED|95.0|-2.2|5.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||5.6|-2.2|0.3084
73959547|NCT02914522|147454634|SUPERIORITY||Difference in Percentages|0.0||||0.9109|TWO_SIDED|95.0|-3.4|3.4|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||3.4|-3.4|0.9109
73898442|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.335||0.009|TWO_SIDED|95.0|-1.537|-0.22||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.220|-1.537|0.009
73959548|NCT02914522|147454640|SUPERIORITY||Difference in Percentages|25.5|||<|0.0001|TWO_SIDED|95.0|16.0|35.0|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.0|16.0|<0.0001
73959549|NCT02914522|147454640|SUPERIORITY||Difference in Percentages|9.2||||0.0658|TWO_SIDED|95.0|-1.1|19.5|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||19.5|-1.1|0.0658
73959550|NCT02914522|147454641|SUPERIORITY||Difference in Percentages|13.0||||0.0024|TWO_SIDED|95.0|5.3|20.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.6|5.3|0.0024
73959551|NCT02914522|147454641|SUPERIORITY||Difference in Percentages|0.9||||0.7951|TWO_SIDED|95.0|-7.0|8.7|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||8.7|-7.0|0.7951
73959552|NCT02914522|147454642|SUPERIORITY||Difference in Percentages|20.8||||0.0055|TWO_SIDED|95.0|7.7|33.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||33.9|7.7|0.0055
73959553|NCT02914522|147454642|SUPERIORITY||Difference in Percentages|8.2||||0.1265|TWO_SIDED|95.0|-4.2|20.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.6|-4.2|0.1265
73838082|NCT01052428|147225135|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.55
73838083|NCT01052428|147225136|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.21
73838084|NCT01052428|147225137|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.006
73838085|NCT01052428|147225138|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.16
73838086|NCT01052428|147225139|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.001
73838087|NCT00871000|147225142|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 1 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against poliovirus type 1, one month after vaccination.||2.7|-2.61|
73959554|NCT02914522|147454643|SUPERIORITY||Difference in Percentages|9.5||||0.0157|TWO_SIDED|95.0|1.8|17.1|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||17.1|1.8|0.0157
73959555|NCT02914522|147454643|SUPERIORITY||Difference in Percentages|5.5||||0.1808|TWO_SIDED|95.0|-2.9|13.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||13.9|-2.9|0.1808
74083789|NCT01499160|147720637|OTHER|Not done due to low accrual||||||||||||Not done due to low accrual|Not done due to low accrual|Not done due to low accrual||Not done due to low accrual|Not done due to low accrual|||
73838088|NCT00871000|147225142|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 2 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 2, one month after vaccination.||2.7|-2.61|
73838089|NCT00871000|147225142|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 3 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.72||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 3, one month after vaccination.||2.72|-2.61|
73959556|NCT02914522|147454644|SUPERIORITY||Difference in Percentages|24.9|||<|0.0001|TWO_SIDED|95.0|14.6|35.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.2|14.6|<0.0001
74083790|NCT00593827|147720655|SUPERIORITY_OR_OTHER|||||||0.03|||||||Log Rank|||||||0.03
74083791|NCT00593827|147720656|SUPERIORITY_OR_OTHER|||||||0.05|||||||Log Rank|||||||0.05
74083792|NCT00593827|147720659|SUPERIORITY_OR_OTHER|||||||0.11|||||||Log Rank|||||||0.11
74083793|NCT01994980|147720683|SUPERIORITY||||||<|0.01||||||This is a calculated p value.|Wilcoxon (Mann-Whitney)|||||||<0.01
74083794|NCT00096460|147720706|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Survival Probability|62.7|||||TWO_SIDED|95.0|43.8|89.6||||||||89.6|43.8|
73898443|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|-0.31|STANDARD_DEVIATION|2.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898444|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.333||0.952|TWO_SIDED|95.0|-0.674|0.634||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.634|-0.674|0.952
73959557|NCT02914522|147454644|SUPERIORITY||Difference in Percentages|9.9||||0.0521|TWO_SIDED|95.0|-1.3|21.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||21.2|-1.3|0.0521
73959558|NCT02914522|147454645|SUPERIORITY||Difference in Percentages|16.0||||0.0005|TWO_SIDED|95.0|7.8|24.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||24.2|7.8|0.0005
73959559|NCT02914522|147454645|SUPERIORITY||Difference in Percentages|4.3||||0.2946|TWO_SIDED|95.0|-3.9|12.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||12.6|-3.9|0.2946
73959560|NCT03399370|147454655|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-57.64|||<|0.0001|TWO_SIDED|95.0|-60.86|-54.43||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-54.43|-60.86|<.0001
73959561|NCT03399370|147454656|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-53.78|||<|0.0001|TWO_SIDED|95.0|-56.23|-51.33||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-51.33|-56.23|<0.0001
73959562|NCT03399370|147454657|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-54.12|||<|0.0001|TWO_SIDED|95.0|-57.37|-50.88||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-50.88|-57.37|<0.0001
73959563|NCT03399370|147454658|SUPERIORITY||Mean Difference (Final Values)|-53.28|||<|0.0001|TWO_SIDED|95.0|-55.75|-50.8||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-50.80|-55.75|<0.0001
73959564|NCT03399370|147454659|SUPERIORITY||Mean Difference (Final Values)|-83.8|||<|0.0001|TWO_SIDED|95.0|-89.25|-77.34||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-77.34|-89.25|<0.0001
73959565|NCT03399370|147454660|SUPERIORITY||Mean Difference (Final Values)|-33.13|||<|0.0001|TWO_SIDED|95.0|-35.3|-30.97||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-30.97|-35.30|<0.0001
73959566|NCT03399370|147454661|SUPERIORITY||Mean Difference (Final Values)|-43.09|||<|0.0001|TWO_SIDED|95.0|-45.5|-40.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-40.67|-45.50|<.0001
73959567|NCT03399370|147454662|SUPERIORITY||Mean Difference (Final Values)|-47.36|||<|0.0001|TWO_SIDED|95.0|-50.25|-44.47||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-44.47|-50.25|<0.0001
73959568|NCT05382104|147454663|EQUIVALENCE|A linear mixed-effects model was applied to natural log (ln)-transformed Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90 percent (%) confidence intervals (CIs) was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|76.62|||||TWO_SIDED|90.0|71.78|81.78|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||81.78|71.78|
73959569|NCT05382104|147454663|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|71.61|||||TWO_SIDED|90.0|67.14|76.37|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||76.37|67.14|
73959570|NCT05382104|147454664|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|84.13|||||TWO_SIDED|90.0|80.74|87.66|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||87.66|80.74|
73959571|NCT05382104|147454664|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|87.35|||||TWO_SIDED|90.0|83.87|90.96|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||90.96|83.87|
73959572|NCT05382104|147454665|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|84.74|||||TWO_SIDED|90.0|81.28|88.34|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||88.34|81.28|
73959573|NCT05382104|147454665|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|87.84|||||TWO_SIDED|90.0|84.3|91.53|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||91.53|84.30|
73959574|NCT03506880|147454671|SUPERIORITY||Mean Difference (Final Values)|0.17|||>|0.05|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was hypothesized that drinking would increase from baseline to 12-month follow-up for those in the AC, but not for those in the SG and MADD conditions.||||>0.05
73959575|NCT03506880|147454672|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.01|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was also hypothesized that teens in the SG and MADD conditions would report significantly more declining rides with impaired drivers than those in the AC group.||||<0.01
73959576|NCT03506880|147454673|SUPERIORITY||Mean Difference (Final Values)|0.06|||>|0.01|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was hypothesized that participants in the MADD and SG groups would be significantly less willing to ride in a car with an impaired driver than those in the AC group.||||>0.01
73959577|NCT05819190|147454689|SUPERIORITY|||||||0.0192|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - FAS set||||0.0192
73959578|NCT05819190|147454690|SUPERIORITY|||||||0.0296|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - PP set||||0.0296
73959579|NCT05819190|147454691|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||||||0.0085
73959580|NCT05819190|147454692|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||||||0.0081
73959581|NCT05819190|147454693|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.0050
73959582|NCT05819190|147454694|SUPERIORITY|||||||0.0107|||||||Wilcoxon (Mann-Whitney)|||||||0.0107
73959583|NCT05819190|147454695|SUPERIORITY|||||||0.0424|||||||Wilcoxon (Mann-Whitney)|||||||0.0424
73959584|NCT05819190|147454696|SUPERIORITY|||||||0.43||||||one sided test|Wilcoxon (Mann-Whitney)|||0.05 global significance level (type I error rate)||||0.430
73959585|NCT05819190|147454697|SUPERIORITY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.339
74083795|NCT00096460|147720706|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Survival Probability|85.7||||||95.0|63.3|100.0||||||||100|63.3|
73959586|NCT05819190|147454698|SUPERIORITY|||||||0.704|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.704
73959587|NCT05819190|147454699|SUPERIORITY|||||||0.298|||||||Wilcoxon (Mann-Whitney)|One sided test||0.05 global significance level (type I error rate)||||0.298
73959588|NCT05819190|147454700|SUPERIORITY|||||||0.906|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.906
73959589|NCT05819190|147454701|SUPERIORITY|||||||0.582|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.582
73959590|NCT05819190|147454702|SUPERIORITY|||||||0.743|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.743
73959591|NCT05819190|147454703|SUPERIORITY|||||||0.605|||||||Fisher Exact|One sided test||0.05 global significance level (type I error rate)||||0.605
73959592|NCT05819190|147454704|SUPERIORITY|||||||1|||||||Fisher Exact|one sided test||0.05 global significance level (type I error rate)||||1.000
73959593|NCT05819190|147454705|SUPERIORITY|||||||0.988|||||||Fisher Exact|One sided test||0.05 global significance level (type I error rate)||||0.988
73898445|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|3.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73959594|NCT05819190|147454706|SUPERIORITY|||||||0.483|||||||Fisher Exact|one sided test||0.05 global significance level (type I error rate)||||0.483
73959595|NCT00430300|147454765|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.0087||||0.0284|TWO_SIDED|95.0|-0.0943|0.0774|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0774|-0.0943|0.0284
73959596|NCT00430300|147454765|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.0389||||0.0056|TWO_SIDED|95.0|-0.1299|0.0471|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0471|-0.1299|0.0056
73959597|NCT00430300|147454765|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.051||||0.0009|TWO_SIDED|95.0|-0.1298|0.029|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0290|-0.1298|0.0009
73959598|NCT00430300|147454766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.5849|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.5849
73959599|NCT00430300|147454766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.9737|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.9737
73959600|NCT00430300|147454766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.387|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.3870
74083796|NCT05194202|147720710|OTHER|||||||0.622|||||||one-sample test of proportions|Hypothesis was evaluated using a one-tailed, one-proportion z-test.||Our null hypothesis for the acceptability was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.||||.622
73959601|NCT00430300|147454766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.8612|ONE_SIDED|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.15|0.8612
73959602|NCT00430300|147454766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.7499|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.7499
73838090|NCT00871000|147225143|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: Upper limit (UL) of the standardised asymptotic 95% confidence interval (CI) on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL was lower than or equal to (≤) 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against diphtheria, one month after vaccination.||2.7|-2.61|
73838091|NCT00871000|147225143|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against tetanus, one month after vaccination.||2.7|-2.61|
73838092|NCT01791205|147225198|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.538||||0.1194|TWO_SIDED|95.0|0.65|19.33||The relation between retention rate and duration of disease for phase II was estimated with the Cox regression model.|Regression, Cox|||The relation between retention rate and DAS28 (\<2.6 vs \<3.2) was assayed with the Cox regression.||19.33|0.65|0.1194
73838093|NCT01791205|147225199|SUPERIORITY_OR_OTHER|||||||0.3895|||||||Regression, Cox|||||||0.3895
73838094|NCT01791205|147225200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.211||||0.49|TWO_SIDED|95.0|0.703|2.086|||Regression, Logistic|||||2.086|0.703|0.4900
73838095|NCT01791205|147225201|SUPERIORITY_OR_OTHER||Delta|-0.042||||0.6908|TWO_SIDED|95.0|-0.251|0.167|||t-test, 2 sided|||||0.167|-0.251|0.6908
73838096|NCT01791205|147225202|SUPERIORITY_OR_OTHER|||||||0.021|||||||Pearson's chi-squared test|||||||0.0210
73838097|NCT04250363|147225259|OTHER||Odds Ratio (OR)|3.57||||0.00284|TWO_SIDED|95.0|1.85|10.6|||Regression, Logistic|||||10.6|1.85|0.00284
73838098|NCT04250363|147225259|OTHER||Odds Ratio (OR)|4.19||||0.00367|TWO_SIDED|95.0|2.0|14.8|||Regression, Logistic|||||14.8|2.00|0.00367
73838099|NCT04250363|147225259|OTHER||Odds Ratio (OR)|4.22||||0.0137|TWO_SIDED|95.0|1.9|23.7|||Regression, Logistic|||||23.7|1.90|0.0137
73838100|NCT04250363|147225259|OTHER||Odds Ratio (OR)|2.23||||0.00349|TWO_SIDED|95.0|1.47|4.48|||Regression, Logistic|||||4.48|1.47|0.00349
73838101|NCT04250363|147225259|OTHER||Odds Ratio (OR)|11.6||||0.00594|TWO_SIDED|95.0|3.19|129.0|||Regression, Logistic|||||129|3.19|0.00594
73838114|NCT02197065|147225289|OTHER||Proportion|0.2|||||ONE_SIDED|||||||||This was a pilot feasibility study and we were only powered to determine the frequency of troponin elevation in the entire study population, not to compare the frequency of a rise in troponin in the two study arms. Thus Aim 1 applies to the entire study cohort.||||
73838115|NCT02197065|147225290|SUPERIORITY||Median Difference (Final Values)|13.0||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.58
73838116|NCT02197065|147225291|SUPERIORITY||Median Difference (Final Values)|0.3||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
73838117|NCT05287685|147225294|OTHER|||||||0.29|||||||t-test, 2 sided|||Preliminary pre-post outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.29
73838118|NCT05287685|147225294|OTHER|||||||0.34|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.34
73838119|NCT05287685|147225294|SUPERIORITY|||||||0.02|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.02
73838120|NCT05287685|147225294|SUPERIORITY|||||||0.04|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.04
73838121|NCT05287685|147225295|OTHER|||||||0.88|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.88
73838122|NCT05287685|147225295|OTHER|||||||0.87|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.87
73838123|NCT05287685|147225295|SUPERIORITY|||||||0.1|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.10
73838124|NCT05287685|147225295|SUPERIORITY|||||||0.9|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.90
73838125|NCT05287685|147225296|EQUIVALENCE|Analysis to test whether groups had equivalent levels of satisfaction with treatment (defined as the groups not being significantly different at the level of p\<.05).||||||0.8|||||||t-test, 2 sided|||T-test analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups.||||.80
73838126|NCT05287685|147225297|OTHER|||||||0.35|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.35
73838127|NCT05287685|147225297|OTHER|||||||0.049|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.049
73838128|NCT05287685|147225297|SUPERIORITY|||||||0.45|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.45
73838129|NCT05287685|147225297|SUPERIORITY|||||||0.2|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.20
73838130|NCT05287685|147225298|OTHER|||||||0.006|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.006
73838131|NCT05287685|147225298|OTHER|||||||0.011|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.011
73838132|NCT05287685|147225298|SUPERIORITY|||||||0.22|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.22
73838133|NCT05287685|147225298|SUPERIORITY|||||||0.25|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.25
73838134|NCT03733483|147225372|EQUIVALENCE|Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on P1NP levels. Change in P1NP in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.||||||0.53|||||||Mixed Models Analysis|||||||0.53
73838135|NCT03733483|147225373|EQUIVALENCE|Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on CTX levels. Change in CTX in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.||||||0.1|||||||Mixed Models Analysis|||||||0.10
73838136|NCT02191397|147225374|NON_INFERIORITY|A one-sided 97.5% confidence interval for the between-treatment difference (bupropion XL-escitalopram) was compared with the pre-defined non-inferiority margin of 2.2. If the upper limit of the one-sided 97.5% confidence interval was below 2.2, then it indicated that bupropion was not inferior in efficacy to escitalopram.|Mean Difference (Final Values)|0.8||||0.139|TWO_SIDED|95.0|-0.27|1.94||Analysis included Baseline HAMD-17 total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Observed Cases (OC) dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.94|-0.27|0.139
73838137|NCT02191397|147225375|OTHER||Odds Ratio (OR)|0.85||||0.479|TWO_SIDED|95.0|0.55|1.33||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables.|GEE model|||||1.33|0.55|0.479
73838138|NCT02191397|147225376|OTHER||Odds Ratio (OR)|0.73||||0.129|TWO_SIDED|95.0|0.48|1.1||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.10|0.48|0.129
73838139|NCT02191397|147225377|OTHER||Odds Ratio (OR)|0.83||||0.354|TWO_SIDED|95.0|0.55|1.24||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.24|0.55|0.354
73838140|NCT02191397|147225378|OTHER||Odds Ratio (OR)|0.85||||0.489|TWO_SIDED|95.0|0.54|1.34||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.34|0.54|0.489
73838141|NCT02191397|147225379|OTHER||Mean Difference (Final Values)|0.2||||0.627|TWO_SIDED|95.0|-0.7|1.16||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.16|-0.70|0.627
73838142|NCT02191397|147225379|OTHER||Mean Difference (Final Values)|1.4||||0.037|TWO_SIDED|95.0|0.08|2.66||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.66|0.08|0.037
73838143|NCT02191397|147225379|OTHER||Mean Difference (Final Values)|1.2||||0.143|TWO_SIDED|95.0|-0.4|2.78||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.78|-0.40|0.143
73838144|NCT02191397|147225379|OTHER||Mean Difference (Final Values)|0.8||||0.33|TWO_SIDED|95.0|-0.81|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.40|-0.81|0.330
73959603|NCT00430300|147454766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.5134|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.5134
73959604|NCT00430300|147454766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.1244|ONE_SIDED|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.04|0.1244
73959605|NCT00430300|147454766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.53|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.5300
73959606|NCT00430300|147454766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.055|ONE_SIDED|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.00|0.0550
73959607|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.7444|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.7444
73959608|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.9134|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.9134
73959609|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.6841|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.6841
73838145|NCT02191397|147225379|OTHER||Mean Difference (Final Values)|0.9||||0.278|TWO_SIDED|95.0|-0.69|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.40|-0.69|0.278
73838146|NCT02191397|147225380|OTHER||Mean Difference (Final Values)|0.0||||0.579|TWO_SIDED|95.0|-0.09|0.16||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.16|-0.09|0.579
73959610|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.9283|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.9283
73838147|NCT02191397|147225380|OTHER||Mean Difference (Final Values)|0.1||||0.163|TWO_SIDED|95.0|-0.04|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.26|-0.04|0.163
73838148|NCT02191397|147225380|OTHER||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.34||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.34|0.00|0.050
73838149|NCT02191397|147225380|OTHER||Mean Difference (Final Values)|0.1||||0.337|TWO_SIDED|95.0|-0.09|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.26|-0.09|0.337
73838150|NCT02191397|147225380|OTHER||Mean Difference (Final Values)|0.0||||0.714|TWO_SIDED|95.0|-0.14|0.2||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.20|-0.14|0.714
73838151|NCT02191397|147225381|OTHER||Mean Difference (Final Values)|-0.2||||0.358|TWO_SIDED|95.0|-0.5|0.18||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.18|-0.50|0.358
73838152|NCT02191397|147225381|OTHER||Mean Difference (Final Values)|0.4||||0.081|TWO_SIDED|95.0|-0.04|0.75||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.75|-0.04|0.081
73838153|NCT02191397|147225381|OTHER||Mean Difference (Final Values)|0.5||||0.062|TWO_SIDED|95.0|-0.02|0.99||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.99|-0.02|0.062
73838154|NCT02191397|147225381|OTHER||Mean Difference (Final Values)|0.4||||0.118|TWO_SIDED|95.0|-0.1|0.85||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.85|-0.10|0.118
73838155|NCT02191397|147225381|OTHER||Mean Difference (Final Values)|0.3||||0.252|TWO_SIDED|95.0|-0.19|0.71||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.71|-0.19|0.252
74083797|NCT05194202|147720711|OTHER|||||||0.038|||||||one sample test of proportions|Hypothesis was evaluated using a one-tailed, one-proportion z-test||Our null hypothesis for the acceptabnility of the ED-Heart was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.||||.038
74083798|NCT00377572|147720736|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Maximum Symptom Day Comparison||||<0.001
74083799|NCT00377572|147720737|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||||||0.04
74083800|NCT00377572|147720738|SUPERIORITY_OR_OTHER|||||||0.1111||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept (to account for within-subject correlation) and visit and group as fixed effects.||||||0.1111
73838156|NCT02191397|147225382|OTHER||Mean Difference (Final Values)|0.1||||0.573|TWO_SIDED|95.0|-0.2|0.35||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.35|-0.20|0.573
73838157|NCT02191397|147225382|OTHER||Mean Difference (Final Values)|0.2||||0.209|TWO_SIDED|95.0|-0.13|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.58|-0.13|0.209
73838158|NCT02191397|147225382|OTHER||Mean Difference (Final Values)|0.2||||0.427|TWO_SIDED|95.0|-0.25|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.58|-0.25|0.427
74083801|NCT00377572|147720739|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Childhood Asthma Control Test comparison||||0.007
74083802|NCT00377572|147720740|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Asthma Control Test comparison||||0.54
74083803|NCT00377572|147720741|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1 % of predicted value comparison||||0.30
74083804|NCT00377572|147720742|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1:FVC ×100 comparison||||0.81
73838159|NCT02191397|147225382|OTHER||Mean Difference (Final Values)|0.0||||0.851|TWO_SIDED|95.0|-0.4|0.48||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.48|-0.40|0.851
73838160|NCT02191397|147225382|OTHER||Mean Difference (Final Values)|0.2||||0.37|TWO_SIDED|95.0|-0.25|0.66||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.66|-0.25|0.370
73838161|NCT02191397|147225383|OTHER||Mean Difference (Final Values)|0.1||||0.438|TWO_SIDED|95.0|-0.16|0.37||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.37|-0.16|0.438
73838162|NCT02191397|147225383|OTHER||Mean Difference (Final Values)|0.4||||0.014|TWO_SIDED|95.0|0.07|0.66||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.66|0.07|0.014
73838163|NCT02191397|147225383|OTHER||Mean Difference (Final Values)|0.2||||0.207|TWO_SIDED|95.0|-0.11|0.5||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.50|-0.11|0.207
73838164|NCT02191397|147225383|OTHER||Mean Difference (Final Values)|0.2||||0.137|TWO_SIDED|95.0|-0.07|0.54||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.54|-0.07|0.137
73838165|NCT02191397|147225383|OTHER||Mean Difference (Final Values)|0.2||||0.299|TWO_SIDED|95.0|-0.14|0.46||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.46|-0.14|0.299
73838166|NCT02191397|147225384|OTHER||Mean Difference (Final Values)|0.0||||0.804|TWO_SIDED|95.0|-0.1|0.13||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.13|-0.10|0.804
73838167|NCT02191397|147225384|OTHER||Mean Difference (Final Values)|0.1||||0.079|TWO_SIDED|95.0|-0.02|0.28||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.28|-0.02|0.079
73838168|NCT02191397|147225384|OTHER||Mean Difference (Final Values)|0.2||||0.036|TWO_SIDED|95.0|0.01|0.38||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.38|0.01|0.036
73838169|NCT02191397|147225384|OTHER||Mean Difference (Final Values)|0.1||||0.248|TWO_SIDED|95.0|-0.08|0.31||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.31|-0.08|0.248
73838170|NCT02191397|147225384|OTHER||Mean Difference (Final Values)|0.2||||0.11|TWO_SIDED|95.0|-0.04|0.35||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.35|-0.04|0.110
73838171|NCT02191397|147225385|OTHER||Odds Ratio, log|0.78||||0.545|TWO_SIDED|95.0|0.35|1.75||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.75|0.35|0.545
73838172|NCT02191397|147225385|OTHER||Odds Ratio (OR)|0.95||||0.822|TWO_SIDED|95.0|0.58|1.54||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.54|0.58|0.822
73838173|NCT02191397|147225385|OTHER||Odds Ratio (OR)|0.57||||0.007|TWO_SIDED|95.0|0.38|0.86||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.86|0.38|0.007
73838174|NCT02191397|147225385|OTHER||Odds Ratio (OR)|0.83||||0.417|TWO_SIDED|95.0|0.54|1.29||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.29|0.54|0.417
73838175|NCT02191397|147225385|OTHER||Odds Ratio (OR)|0.83||||0.485|TWO_SIDED|95.0|0.49|1.4||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.40|0.49|0.485
73838176|NCT03721107|147225401|SUPERIORITY||Difference in Percentage|7.9||||0.152|TWO_SIDED|95.0|-6.0|21.9||P-value is from a 1-sided Pearson chi-square test with Yates' correction with null hypothesis that the difference in proportions Blautix - placebo \<=0 versus the difference is \>0. The significance level for rejection of the null hypotheses is 0.10.|Chi-squared, Corrected|||||21.9|-6.0|0.152
73838177|NCT03721107|147225401|SUPERIORITY||Difference in Percentage|5.6||||0.216|TWO_SIDED|95.0|-6.8|18.0||P-value is from a 1-sided Pearson chi-square test with Yates' correction with null hypothesis that the difference in proportions Blautix - placebo \<=0 versus the difference is \>0. The significance level for rejection of the null hypotheses is 0.10.|Chi-squared, Corrected|||||18.0|-6.8|0.216
73838178|NCT03888482|147225410|NON_INFERIORITY|Non-inferiority margin = 0.05|Least Squares Mean Difference|0.0|||||ONE_SIDED|95.0||0.01|||Mixed effects repeated measures model|Mixed effects repeated measures model with terms for lens, period and sequence as fixed effects and subject as a random effect.|Difference = DDT2 - Clariti|||0.01||
73838179|NCT02554474|147225411|SUPERIORITY||Adjusted difference in mean change|9.4|||||TWO_SIDED|95.0|-0.5|19.3||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in MVPA at 9 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking.||19.3|-0.5|
73838180|NCT02554474|147225412|SUPERIORITY||Adjusted difference in mean change|-10.4|||||TWO_SIDED|95.0|-53.4|32.6||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing sedentary time at 9 weeks (primary end point) between groups, adjusting for baseline sedentary time, diagnosis, and blocking.||32.6|-53.4|
73838181|NCT02554474|147225413|SUPERIORITY||Adjusted difference in mean change|-0.31|||||TWO_SIDED|95.0|-0.63|0.01||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in the Fatigue Severity Scale at 9 weeks (primary end point) between groups, adjusting for baseline fatigue score, diagnosis, and blocking.||0.01|-0.63|
73838182|NCT02554474|147225414|SUPERIORITY||Adjusted difference in mean change|-2.45|||||TWO_SIDED|95.0|-4.78|-0.13||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing pain at 9 weeks (primary end point) between groups, adjusting for pain score, diagnosis, and blocking.||-0.13|-4.78|
73838183|NCT02554474|147225415|SUPERIORITY||Adjusted difference in mean change|-0.22|||||TWO_SIDED|95.0|-1.78|1.35||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the PHQ-9 scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||1.35|-1.78|
73838184|NCT02554474|147225416|SUPERIORITY||Adjusted difference in mean change|1.58|||||TWO_SIDED|95.0|-1.02|4.18||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the Partners In Health Scale scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||4.18|-1.02|
73838185|NCT02554474|147225417|SUPERIORITY||Adjusted difference in mean change|0.05|||||TWO_SIDED|95.0|-0.05|0.16||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Work index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.16|-0.05|
73838186|NCT02554474|147225418|SUPERIORITY||Adjusted difference in mean change|0.0|||||TWO_SIDED|95.0|-0.37|0.37||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Leisure index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.37|-0.37|
73838187|NCT02554474|147225419|SUPERIORITY||Adjusted difference in mean change|0.54|||||TWO_SIDED|95.0|0.08|0.99||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Walking index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.99|0.08|
73838188|NCT02991859|147225420|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||FF E0 (Response of Placebo participants)|||19.39|9.39|
73838189|NCT02991859|147225420|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||Emax-Maximum Dose response|||25.40|8.21|
73838190|NCT02991859|147225420|OTHER||3 parameter Emax model|48.52|||||TWO_SIDED|95.0|18.21|129.32|||||ED50-Dose at which 50% of the maximum dose response reached (mcg)|||129.32|18.21|
73838191|NCT02991859|147225420|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||FP E0-Response of Placebo participants|||19.39|9.39|
73838192|NCT02991859|147225420|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||FP Emax-Maximum Dose response|||25.40|8.21|
73838193|NCT02991859|147225420|OTHER||3 parameter Emax model|1081.27|||||TWO_SIDED|95.0|448.0|2609.66|||||FP ED50-Dose at which 50% of the maximum dose response reached (mcg)|||2609.66|448.00|
73838194|NCT02991859|147225420|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||BUD E0-Response of Placebo participants|||19.39|9.39|
73838195|NCT02991859|147225420|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||BUD Emax-Maximum Dose response|||25.40|8.21|
73838196|NCT02991859|147225420|OTHER||3 parameter Emax model|1467.36|||||TWO_SIDED|95.0|546.51|3939.84|||||BUD ED50-Dose at which 50% of the maximum dose response reached (mcg)|||3939.84|546.51|
73838197|NCT02991859|147225421|OTHER||Exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||FF E0-Response of Placebo participants|||190.38|162.87|
73838198|NCT02991859|147225421|OTHER||exponential power-law model|899.99|||||TWO_SIDED|95.0|698.36|1101.62|||||FF ED50 Dose at which 50% of the maximum dose response reached|||1101.62|698.36|
73838199|NCT02991859|147225421|OTHER||exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||FP E0-Response of Placebo participants|||190.38|162.87|
73838200|NCT02991859|147225421|OTHER||exponential power-law model|1986.05|||||TWO_SIDED|95.0|1574.7|2397.39|||||FP ED50 - Dose at which 50% of the maximum dose response reached (mcg)|||2397.39|1574.70|
73838201|NCT02991859|147225421|OTHER||exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||BUD E0 - Response of Placebo participants|||190.38|162.87|
73838202|NCT02991859|147225421|OTHER||exponential power-law model|1927.42|||||TWO_SIDED|95.0|1698.47|2156.37|||||BUD ED50 - Dose at which 50% of the maximum dose response reached (mcg)|||2156.37|1698.47|
73838203|NCT02991859|147225422|OTHER||Emax Model|289.73|||||TWO_SIDED|95.0|224.82|354.64|||||ED20 Cortisol Suppression 0-24 Hours Weighted Mean|||354.64|224.82|
73838204|NCT02991859|147225422|OTHER||Emax Model|194.09|||||TWO_SIDED|95.0|72.82|517.28|||||ED80 for AMP PC20|||517.28|72.82|
73838205|NCT02991859|147225423|OTHER||Emax Model|639.36|||||TWO_SIDED|95.0|506.94|771.79|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean|||771.79|506.94|
73838206|NCT02991859|147225423|OTHER||Emax Model|4325.07|||||TWO_SIDED|95.0|1792.02|10438.64|||||ED80 for AMP PC20|||10438.64|1792.02|
73838207|NCT02991859|147225424|OTHER||Emax Model|620.49|||||TWO_SIDED|95.0|546.79|694.2|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean|||694.20|546.79|
73838208|NCT02991859|147225424|OTHER||Emax Model|5869.45|||||TWO_SIDED|95.0|2186.03|15759.35|||||ED80 for AMP PC20|||15759.35|2186.03|
73838209|NCT04223687|147225476|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||<0.01
73838210|NCT04223687|147225477|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|t-test, 2 sided|||||||<0.01
73838211|NCT04223687|147225478|SUPERIORITY|||||||0.03||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.03
73838212|NCT04223687|147225479|SUPERIORITY|||||||0.37||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||0.37
73838213|NCT04223687|147225480|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
73838214|NCT04223687|147225481|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
73838215|NCT04223687|147225482|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
73838216|NCT04223687|147225483|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||<0.001
73838217|NCT04223687|147225484|SUPERIORITY|||||||0.06||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.06
73838218|NCT04223687|147225485|SUPERIORITY|||||||0.37||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.37
73838219|NCT04223687|147225486|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
73838220|NCT04223687|147225487|SUPERIORITY|||||||0.42||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.42
73838221|NCT04223687|147225488|SUPERIORITY|||||||0.13||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.13
73838222|NCT04223687|147225489|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
73838223|NCT00425854|147225493|SUPERIORITY_OR_OTHER||Maximum Likelihood|0.048|||||TWO_SIDED|95.0|0.001|0.238|||||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort B. The CI is an exact Clopper Pearson CI.|||0.238|0.001|
73838224|NCT00425854|147225498|SUPERIORITY_OR_OTHER||Clinical benefit rate|0.1|||||TWO_SIDED|95.0|0.02|0.27|||Maxium Likelihood||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort A. The confidence interval (CI) is an exact Clopper Pearson CI.|||0.27|0.02|
73838225|NCT01378273|147225503|SUPERIORITY|We assumed no effect of treatment on death, but that Epo will lead to a decrease in the rate of NDI. If we assume a multiplicative reduction in the NDI rate of 0.45 then we expect a treated NDI rate of 12 percent and an overall rate of death+NDI of 30.4% as compared to the control rate of 40.4% corresponding to an overall treatment rate ratio of 0.75. This leads to a sample size of 376 evaluated subjects per arm or a total evaluated sample size of 752 subjects.|Risk Ratio (RR)|1.03||||0.05|TWO_SIDED|0.05|0.81|1.32||A two-sided type I error of 0.05 with no formal adjustment for multiple comparisons unless otherwise specified (such as with safety outcomes).|GEE Wald test based on logistic regressi|adjustments were made for gestational age at birth and recruitment site as a fixed effect.|The numerator is the Epo group, denominator is the control group|We evaluated the primary outcome of death or neurodevelopmental impairment using generalized estimating equations to account for potential correlation within siblings from the same pregnancy, with adjustment for gestational age at birth and recruitment site as a fixed effect. The primary analysis included infants with complete data and excluded data from infants known to be alive but in whom neurodevelopmental outcomes were not assessed.||1.32|0.81|0.05
73838226|NCT01378273|147225504|OTHER|SAEs were defined prospectively. The rate of total SAEs observed through hospital discharge were compared after accounting for potential within-sibship correlation (with multiple gestations) using Generalized Estimating Equations (GEE) with robust standard errors. We used a GEE Wald test based on Poisson or logistic regression for total SAE count and individual events respectively. All other non-categorical data were assessed with GEE regression models appropriate for continuous outcomes.|Risk Ratio (RR)|1.01||||0.05|TWO_SIDED|95.0|0.83|1.22||Statistical significance was set at 0.05 for the efficacy analysis and for the final safety analysis comparing the rate of total SAEs between treatment groups, and 0.031 for death and 0.004 for the ten individual SAEs due to sequential monitoring.|Poisson regression|Adjusted for multiple gestation and gestational age|Epo is numerator and Control is denominator|We hypothesized that Epo would be safe, with no excess of SAEs compared to control infants. Sample size was based on the primary outcome, severe neurodevelopmental impairment or death.||1.22|0.83|0.05
73838227|NCT01378273|147225505|SUPERIORITY|||||||0.36||||||Statistical significance was evaluated using a Wald's test and declared significant if p \< 0.05.|Generalized estimating equation|Adjusted for gestational age at birth and treatment assignment.||For all statistical comparisons between groups, Generalized Estimating Equations (GEE) with robust standard errors and a working independence correlation structure for infants included from a multiple gestation were used. A GEE-based Wald test was used to examine differences in the global brain injury severity score between treatment groups, with adjustment for gestational age (GA) at birth used to stratify treatment randomization (24+0 to 25+6 vs. 26+0 to 27+6 in weeks+days of GA).||||0.36
73838228|NCT01378273|147225506|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a Wald's test and declared significant if p \< 0.007.|Generalized estimating equation|Adjusted for gestational age at birth and treatment assignment.||For statistical inference, we utilized generalized estimating equations (GEE) with robust standard errors to appropriately account for potential correlation of biomarkers for same-birth siblings. Each respective GEE model adjusted for gestational age at birth and treatment assignment as fixed factors associated with the original study design. Biomarker levels at each follow-up time point were analysed using separate GEE models. Epo levels were log-transformed in all statistical analyses.||||<0.001
73838229|NCT03163264|147225510|SUPERIORITY||Mean Difference (Net)|0.05||||0.05|TWO_SIDED|95.0|0.0|3.45||"Statistical test was 2 sided with p\<0.05 indicating statistical significance. Note: Estimated p-value was calculated at 0.050"|Mixed Models Analysis|This analysis was in our grant and protocol paper but was added late to clinicaltrials.gov.||||3.45|0|0.050
73838230|NCT03163264|147225510|SUPERIORITY||Mean Difference (Net)|0.05||||0.05|TWO_SIDED|||||"Statistical test was 2 sided with p\<0.05 indicating statistical significance. Note: Estimated p-value was calculated at 0.05"|Wilcoxon (Mann-Whitney)|The investigators will also use repeated measures modeling based on mixed models using baseline and follow up data to adjust for characteristics||||||0.05
73838231|NCT03163264|147225511|SUPERIORITY||Mean Difference (Net)|0.069||||0.069|TWO_SIDED|95.0|-0.13|3.39||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|This analysis was in our grant and protocol paper but was added late to clinicaltrials.gov.||||3.39|-0.13|0.069
73838232|NCT03163264|147225511|SUPERIORITY||Mean Difference (Final Values)|1.53||||0.028|TWO_SIDED|95.0|0.21|3.76||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Wilcoxon (Mann-Whitney)|The investigators will also use repeated measures modeling based on mixed models using baseline and follow up data to adjust for characteristics||||3.76|0.21|0.028
73838233|NCT03163264|147225512|SUPERIORITY||Percent Difference|11.18||||0.033|TWO_SIDED|95.0|0.92|21.45|||Mixed Models Analysis|||||21.45|0.92|0.033
73838234|NCT03163264|147225513|SUPERIORITY||Percent Difference|11.08||||0.073|TWO_SIDED|95.0|-1.05|23.2||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis||Adjusted|||23.2|-1.05|0.073
73838235|NCT03163264|147225515|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.065|TWO_SIDED|95.0|-0.05|1.48||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||1.48|-0.05|0.065
73898446|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.324||0.764|TWO_SIDED|95.0|-0.54|0.734||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.734|-0.540|0.764
73838236|NCT03163264|147225516|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.378|TWO_SIDED|95.0|-0.52|1.37||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||1.37|-0.52|0.378
73838237|NCT03163264|147225518|SUPERIORITY||Mean Difference (Final Values)|8.35||||0.911|TWO_SIDED|95.0|-138.25|154.95||Statistical test was 2 sided with p\<0.05 indicating statistical significance|Mixed Models Analysis|||||154.95|-138.25|0.911
73838238|NCT03163264|147225519|SUPERIORITY||Mean Difference (Final Values)|32.83||||0.648|TWO_SIDED|95.0|-108.15|173.81||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||173.81|-108.15|0.648
73838239|NCT03163264|147225520|SUPERIORITY||Percent Difference|10.32||||0.736|TWO_SIDED|95.0|-49.73|70.37||Statistical test was 2 sided with p\<0.05 indicating statistical significance|Mixed Models Analysis|||||70.37|-49.73|0.736
73838240|NCT03163264|147225521|SUPERIORITY||Percent Difference|19.36||||0.53|TWO_SIDED|95.0|-41.09|79.8||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||79.8|-41.09|0.53
73838241|NCT05259722|147225554|SUPERIORITY||Mean Difference (Net)|-16.1|||<|0.001|TWO_SIDED|95.0|-23.28|-8.86|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-8.86|-23.28|<0.001
73838242|NCT05259722|147225555|SUPERIORITY||Risk Difference (RD)|12.6|||=|0.003|TWO_SIDED|95.0|4.34|20.78|||Cochran-Mantel-Haenszel|||The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by hyperkeratotic/non-hyperkeratotic subtype. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||20.78|4.34|=0.003
73838243|NCT05259722|147225556|SUPERIORITY||Risk Difference (RD)|10.6|||=|0.004|TWO_SIDED|95.0|3.31|17.87|||Cochran-Mantel-Haenszel|||The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by hyperkeratotic/non-hyperkeratotic subtype. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||17.87|3.31|=0.004
73838244|NCT05259722|147225557|SUPERIORITY||Mean Difference (Net)|-0.7|||=|0.005|TWO_SIDED|95.0|-1.12|-0.2|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-0.20|-1.12|=0.005
73838245|NCT05259722|147225558|SUPERIORITY||Mean Difference (Net)|-0.6|||=|0.018|TWO_SIDED|95.0|-1.08|-0.1|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-0.10|-1.08|=0.018
73898447|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|2.85|||TWO_SIDED|||||||||Week 48||||
73838246|NCT05259722|147225559|SUPERIORITY||Mean Difference (Net)|14.3|||<|0.001|TWO_SIDED|95.0|5.81|22.86|||ANCOVA|||The AUC was analysed using a robust ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||22.86|5.81|<0.001
73838247|NCT05259722|147225560|SUPERIORITY||Mean Difference (Net)|334.0|||<|0.001|TWO_SIDED|95.0|195.69|472.26|||ANCOVA|||The AUC was analysed using a robust ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||472.26|195.69|<0.001
73838248|NCT05259722|147225561|SUPERIORITY||Mean Difference (Net)|-24.5|||<|0.001|TWO_SIDED|95.0|-32.55|-16.36|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-16.36|-32.55|<0.001
73838249|NCT00498485|147225602|SUPERIORITY_OR_OTHER||||||<|0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis = drug-treated would have a higher global impression of change than placebo treated.||||<0.04
73838250|NCT03072875|147225604|OTHER|Descriptive statistic.|||||||||||||||||Quantitative data (descriptive statistic) from the USAQ were used to determine feasibility. Specifically, we established an a priori mean score of 3.5 or greater on the USAQ to determine feasibility.|||
73838251|NCT03478787|147225606|NON_INFERIORITY|Non-inferiority is met if the lower bound of the 96.25% confidence interval (CI) of adjusted treatment difference is above -12%.|Adjusted percentage difference|8.2|||||TWO_SIDED|96.25|-2.2|18.6|||||Across the strata, 96.25% confidence interval (CI) for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||18.6|-2.2|
73838252|NCT03478787|147225607|SUPERIORITY||Adjusted percentage difference|29.8|||<|0.001|TWO_SIDED|95.0|20.8|38.8||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||38.8|20.8|< 0.001
73838253|NCT03478787|147225608|SUPERIORITY||Adjusted percentage difference|26.2|||<|0.001|TWO_SIDED|95.0|15.9|36.5||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||36.5|15.9|< 0.001
73838254|NCT03478787|147225609|SUPERIORITY||Adjusted percentage difference|29.8|||<|0.001|TWO_SIDED|95.0|20.9|38.8||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||38.8|20.9|< 0.001
73838255|NCT03478787|147225610|SUPERIORITY||Adjusted percentage difference|20.0|||<|0.001|TWO_SIDED|95.0|11.7|28.3||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||28.3|11.7|< 0.001
73838256|NCT01539525|147225611|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.118|-0.038|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the linear effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.038|-0.118|<0.001
73838257|NCT01539525|147225611|SUPERIORITY_OR_OTHER||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.003||0.066|TWO_SIDED|95.0|-0.0004|0.011|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the quadratic effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.011|-0.0004|0.066
73838258|NCT01539525|147225611|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.034||0.038|TWO_SIDED|95.0|-0.151|-0.004||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.004|-0.151|0.038
73838259|NCT01539525|147225611|SUPERIORITY_OR_OTHER||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.034||0.008|TWO_SIDED|95.0|-0.157|-0.023||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.025|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.023|-0.157|0.008
73838260|NCT01539525|147225611|SUPERIORITY_OR_OTHER||Slope|0.011|STANDARD_ERROR_OF_MEAN|0.005||0.031|TWO_SIDED|95.0|0.001|0.022||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.022|0.001|0.031
73838261|NCT01539525|147225611|SUPERIORITY_OR_OTHER||Slope|0.012|STANDARD_ERROR_OF_MEAN|0.0005||0.01|TWO_SIDED|95.0|0.002|0.021||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.025.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.021|0.002|0.010
73838262|NCT01539525|147225612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.931||||0.81|TWO_SIDED|95.0|0.559|1.551|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Nurse vs. Treatment as Usual|||1.551|0.559|0.810
73838263|NCT01539525|147225612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.968||||0.99|TWO_SIDED|95.0|0.579|1.617|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Computer vs. Treatment as Usual|||1.617|0.579|0.990
73838264|NCT01539525|147225613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.258||||0.465|TWO_SIDED|95.0|0.409|3.871|||Regression, Logistic|adjusted for stratifying variables- primary drug and pregnancy status|odds ratio estimate is for Motivational Interview- Nurse vs. Treatment as Usual|||3.871|0.409|0.465
73838265|NCT01539525|147225613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.749||||0.49|TWO_SIDED|95.0|0.205|2.732|||Regression, Logistic||Odds ratio estimate is for Motivational Interview- Computer vs. Treatment as Usual|||2.732|0.205|0.490
73838266|NCT01712074|147225615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.695|STANDARD_ERROR_OF_MEAN|0.8697||0.4256|TWO_SIDED|80.0|-0.424|1.814|||Mixed Models Analysis|||||1.814|-0.424|0.4256
73838267|NCT01712074|147225616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.194|STANDARD_ERROR_OF_MEAN|1.7149||0.2027|TWO_SIDED|80.0|-0.013|4.401|||Mixed Models Analysis|||||4.401|-0.013|0.2027
73838268|NCT02474901|147225646|EQUIVALENCE|Looked for statistically-significant difference in numbers of adverse events between the two groups, used a p-value of 0.05 as the cutoff value for significance.|||||<|0.05|||||||Chi-squared, Corrected|Groups were compared with Yates-corrected chi-square test or Fisher exact test for binary or categorical variables.||||||<0.05
73838269|NCT02539394|147225649|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.394|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Burden is the same across the 2 arms||||0.394
73838270|NCT02539394|147225649|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.017|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Burden is the same across the 2 arms||||0.017
73838271|NCT02539394|147225649|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.015|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Burden is the same across the 2 arms||||0.015
73838272|NCT02539394|147225649|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.125|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Burden is the same across the 2 arms||||0.125
73838273|NCT02539394|147225650|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.043|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Eating desire is the same across the 2 arms||||0.043
73838274|NCT02539394|147225650|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.606|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Eating desire is the same across the 2 arms||||0.606
73838275|NCT02539394|147225650|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.155|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Eating desire is the same across the 2 arms||||0.155
73838276|NCT02539394|147225650|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.019|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Eating desire is the same across the 2 arms||||0.019
73838277|NCT02539394|147225651|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.25|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Eating duration is the same across the 2 arms||||0.250
73838278|NCT02539394|147225651|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.478|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Eating duration is the same across the 2 arms||||0.478
73838279|NCT02539394|147225651|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.019|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Eating duration is the same across the 2 arms||||0.019
73838280|NCT02539394|147225651|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.049|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Eating duration is the same across the 2 arms||||0.049
74083805|NCT00377572|147720743|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||||||<0.0001
73838281|NCT02539394|147225652|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.376|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Food selection is the same across the 2 arms||||0.376
73838282|NCT02539394|147225652|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.013|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Food selection is the same across the 2 arms||||0.013
73838283|NCT02539394|147225652|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.049|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Food selection is the same across the 2 arms||||0.049
73838284|NCT02539394|147225652|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.3|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Food selection is the same across the 2 arms||||0.300
73838285|NCT02539394|147225653|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.037|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Communication is the same across the 2 arms||||0.037
73838286|NCT02539394|147225653|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.858|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Communication is the same across the 2 arms||||0.858
73838287|NCT02539394|147225653|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Communication is the same across the 2 arms||||0.042
73838288|NCT02539394|147225653|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.031|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Communication is the same across the 2 arms||||0.031
73838289|NCT02539394|147225654|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.343|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Fear swallow is the same across the 2 arms||||0.343
73838290|NCT02539394|147225654|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.022|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Fear swallow is the same across the 2 arms||||0.022
73838291|NCT02539394|147225654|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.018|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Fear swallow is the same across the 2 arms||||0.018
73838292|NCT02539394|147225654|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.008|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Fear swallow is the same across the 2 arms||||0.008
73838293|NCT02539394|147225655|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.28|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Social is the same across the 2 arms||||0.280
73838294|NCT02539394|147225655|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.483|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Social is the same across the 2 arms||||0.483
73838295|NCT02539394|147225655|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.07|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Social is the same across the 2 arms||||0.070
73838296|NCT02539394|147225655|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.2|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Social is the same across the 2 arms||||0.200
73838297|NCT02539394|147225656|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.148|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Mental is the same across the 2 arms||||0.148
73838298|NCT02539394|147225656|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Mental is the same across the 2 arms||||0.040
73838299|NCT02539394|147225656|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Mental is the same across the 2 arms||||0.042
73838300|NCT02539394|147225656|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.319|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Mental is the same across the 2 arms||||0.319
73838301|NCT02539394|147225657|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.161|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Sleep is the same across the 2 arms||||0.161
73838302|NCT02539394|147225657|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.763|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Sleep is the same across the 2 arms||||0.763
73838303|NCT02539394|147225657|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.178|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Sleep is the same across the 2 arms||||0.178
73838304|NCT02539394|147225657|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.091|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Sleep is the same across the 2 arms||||0.091
73838305|NCT02539394|147225658|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.602|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Fatigue is the same across the 2 arms||||0.602
73838306|NCT02539394|147225658|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.302|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Fatigue is the same across the 2 arms||||0.302
73838307|NCT02539394|147225658|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.114|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Fatigue is the same across the 2 arms||||0.114
73838308|NCT02539394|147225658|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.005|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Fatigue is the same across the 2 arms||||0.005
73838309|NCT02539394|147225659|EQUIVALENCE|Two-sided 95% confidence interval||||||0.933|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative Eat-10 is the same across the 2 arms||||0.933
73838310|NCT02539394|147225659|EQUIVALENCE|Two-sided 95% confidence interval||||||0.95|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative modified Eat-10 is the same across the 2 arms||||0.950
73838311|NCT02539394|147225659|EQUIVALENCE|Two-sided 95% confidence interval||||||0.059|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 Eat-10 is the same across the 2 arms||||0.059
73838312|NCT02539394|147225659|EQUIVALENCE|Two-sided 95% confidence interval||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 modified Eat-10 is the same across the 2 arms||||0.042
73838313|NCT02539394|147225659|EQUIVALENCE|Two-sided 95% confidence interval||||||0.032|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 Eat-10 is the same across the 2 arms||||0.032
73838314|NCT02539394|147225659|EQUIVALENCE|Two-sided 95% confidence interval||||||0.014|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 modified Eat-10 is the same across the 2 arms||||0.014
73838315|NCT02539394|147225659|EQUIVALENCE|Two-sided 95% confidence interval||||||0.03|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks Eat-10 is the same across the 2 arms||||0.030
73838316|NCT02539394|147225659|EQUIVALENCE|Two-sided 95% confidence interval||||||0.039|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks modified Eat-10 is the same across the 2 arms||||0.039
73838317|NCT02539394|147225660|EQUIVALENCE|Two-sided||||||0.121|||||||Chi-squared|||Proportion of Pre-operative Bazaz Liquid is the same between the 2 arms||||0.121
73838318|NCT02539394|147225660|EQUIVALENCE|Two-sided||||||0.006|||||||Chi-squared|||Proportion of POD1 Bazaz Liquid is the same between the 2 arms||||0.006
73838319|NCT02539394|147225660|EQUIVALENCE|Two-sided||||||0.329|||||||Chi-squared|||Proportion of POD2 Bazaz Liquid is the same between the 2 arms||||0.329
73838320|NCT02539394|147225660|EQUIVALENCE|Two-sided||||||0.687|||||||Chi-squared|||Proportion of 4-6 weeks Bazaz Liquid is the same between the 2 arms||||0.687
73838321|NCT02539394|147225661|EQUIVALENCE|Two-sided||||||0.066|||||||Chi-squared|||Proportion of Pre-operative Bazaz Solid is the same between the 2 arms||||0.066
73838322|NCT02539394|147225661|EQUIVALENCE|Two-sided||||||0.252|||||||Chi-squared|||Proportion of POD1 Bazaz Solid is the same between the 2 arms||||0.252
73838323|NCT02539394|147225661|EQUIVALENCE|Two-sided||||||0.1|||||||Chi-squared|||Proportion of POD2 Bazaz Solid is the same between the 2 arms||||0.100
73838324|NCT02539394|147225661|EQUIVALENCE|Two-sided||||||0.279|||||||Chi-squared|||Proportion of 4-6 weeks Bazaz Solid is the same between the 2 arms||||0.279
73838325|NCT02539394|147225662|EQUIVALENCE|Two-sided 95% confidence interval||||||0.145|||||||t-test, 2 sided|||The means Pre-operative NDI for the two populations is equal||||0.145
73838326|NCT02539394|147225662|EQUIVALENCE|Two-sided 95% confidence interval||||||0.234|||||||t-test, 2 sided|||The means 4-6 weeks NDI for the two populations is equal||||0.234
73838327|NCT02539394|147225667|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
73838328|NCT01044693|147225674|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||0.036
73838329|NCT01044693|147225674|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||<0.001
73838330|NCT01044693|147225674|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||>0.05
73838331|NCT01044693|147225675|SUPERIORITY_OR_OTHER|||||||0.607|TWO_SIDED||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.||||0.607
73838332|NCT01044693|147225676|SUPERIORITY_OR_OTHER|||||||0.597|TWO_SIDED||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.||||0.597
73838333|NCT01044693|147225677|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The main comparisons were between the negative chronotropic effect of nebivolol and metoprolol at the time when BP-lowering effects were maximal.||||0.996
73838334|NCT02205359|147225678|SUPERIORITY||Hazard Ratio (HR)|0.888|STANDARD_ERROR_OF_MEAN|0.067||0.077|TWO_SIDED|95.0|0.779|1.013|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.013|0.779|0.077
73959611|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.2991|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.2991
73838335|NCT02205359|147225679|SUPERIORITY||Hazard Ratio (HR)|0.881|STANDARD_ERROR_OF_MEAN|0.081||0.12|TWO_SIDED|95.0|0.752|1.032|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.032|0.752|0.12
73838336|NCT02205359|147225680|SUPERIORITY||Hazard Ratio (HR)|0.906|STANDARD_ERROR_OF_MEAN|0.09||0.28|TWO_SIDED|95.0|0.759|1.082|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.082|0.759|0.28
73838337|NCT02205359|147225681|SUPERIORITY|Endpoint for statistical analysis is the proportion Improved.|Odds Ratio (OR)|0.888|STANDARD_ERROR_OF_MEAN|0.074||0.11|TWO_SIDED|95.0|0.768|1.026|||Regression, Logistic|Stratified by NYHA class and with investigational site as a random effect|Standard Error is on log-odds ratio scale|||1.026|0.768|0.11
73838338|NCT02205359|147225682|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.89|TWO_SIDED|95.0|0.85|1.16|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect||||1.16|0.85|0.89
73838339|NCT02205359|147225683|SUPERIORITY||Difference in mean change from baseline|-0.07||||0.88|TWO_SIDED|95.0|-1.03|0.89|||ANCOVA|Stratified by NYHA class and with investigational site as a random effect||||0.89|-1.03|0.88
73838340|NCT02205359|147225684|SUPERIORITY||Difference in mean change from baseline|0.0013||||0.75|TWO_SIDED|95.0|-0.0068|0.0094|||ANCOVA|Stratified by NYHA class and with investigational site as a random effect||||0.0094|-0.0068|0.75
73838341|NCT02205359|147225685|SUPERIORITY||rate ratio|1.15||||0.52|TWO_SIDED|95.0|0.75|1.75|||negative binomial regression|Stratified by NYHA class||||1.75|0.75|0.52
73838342|NCT02792257|147225690|SUPERIORITY||Difference in slopes|-0.74|STANDARD_ERROR_OF_MEAN|0.3||0.015|TWO_SIDED|95.0|-1.328|-0.152|||Regression, Linear||standard error NOT standard error of the mean|Efficacy is assessed by fitting a longitudinal linear GEE model with the co primary outcomes and with time, treatment arm, and their interaction. Analyses are adjusted for site and for use of antidepressants and antipsychotics at baseline. The treatment by week interaction is the coefficient of interest and represents the difference in change in outcome per week between the two arms.||-0.152|-1.328|.015
73838343|NCT02792257|147225691|SUPERIORITY||Difference in slopes|-1.26|STANDARD_ERROR_OF_MEAN|0.75||0.094|TWO_SIDED|95.0|-2.73|0.21|||Regression, Linear||standard error not standard error of the mean|Efficacy is assessed by fitting a longitudinal linear GEE model with the co primary outcomes and with time, treatment arm, and their interaction. Analyses are adjusted for site and for use of antidepressants and antipsychotics at baseline. The treatment by week interaction is the coefficient of interest and represents the difference in change in outcome per week between the two arms.||0.21|-2.73|.094
73838344|NCT02792257|147225692|SUPERIORITY||Incident rate ratio|1.14|STANDARD_ERROR_OF_MEAN|0.26||0.57|TWO_SIDED|95.0|0.73|1.79|||Regression, Logistic|The original analytic plan called for a logistic regression of ever/never SAE as a function of treatment assignment.|not standard error of the mean just standard error.|||1.79|0.73|.57
73838345|NCT00553475|147225693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.0075||95.0|-1.09|-0.17|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.09|0.0075
73838346|NCT00553475|147225693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.0254||95.0|-1.39|-0.09|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.09|-1.39|0.0254
73838347|NCT00553475|147225694|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28||||0.8731||95.0|-3.67|3.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.12|-3.67|0.8731
73838348|NCT00553475|147225694|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.16||||0.6337||95.0|-3.62|5.94|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.94|-3.62|0.6337
73838349|NCT00553475|147225695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.1||||0.4398||95.0|-7.44|3.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.24|-7.44|0.4398
73838350|NCT00553475|147225695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.9153||95.0|-7.96|7.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.14|-7.96|0.9153
73838351|NCT00553475|147225696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.4873||95.0|-2.75|5.76|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.76|-2.75|0.4873
73838352|NCT00553475|147225696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.56||||0.4008||95.0|-3.42|8.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.53|-3.42|0.4008
73838353|NCT00553475|147225697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.5372||95.0|-2.13|4.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.09|-2.13|0.5372
73838354|NCT00553475|147225697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.09||||0.348||95.0|-2.29|6.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.47|-2.29|0.3480
73838355|NCT00553475|147225698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.06||||0.0544||95.0|-0.1|10.21|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.21|-0.10|0.0544
73838356|NCT00553475|147225698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.15||||0.0278||95.0|0.89|15.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||15.42|0.89|0.0278
73838357|NCT00553475|147225699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92||||0.7394||95.0|-4.52|6.37|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.37|-4.52|0.7394
73838358|NCT00553475|147225699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.22||||0.5712||95.0|-5.49|9.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.93|-5.49|0.5712
73838359|NCT00553475|147225700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67||||0.0058||95.0|-1.14|-0.19|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.19|-1.14|0.0058
73838360|NCT00553475|147225700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0333||95.0|-1.23|-0.05|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-1.23|0.0333
73959612|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.7403|ONE_SIDED|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.15|0.7403
73959613|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.3499|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.3499
73959614|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.2734|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.2734
73959615|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.5806|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.5806
73959616|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.11||0.054|ONE_SIDED|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.00|0.0540
73959617|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.2616|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.2616
73959618|NCT00430300|147454767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.0724|ONE_SIDED|95.0|-0.02||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.02|0.0724
73959619|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.1||0.9362|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.9362
73959620|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.9469|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.9469
73959621|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.9153|ONE_SIDED|95.0|-0.27||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.27|0.9153
73959622|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.9686|ONE_SIDED|95.0|-0.36||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.36|0.9686
73959623|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1548|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1548
73838361|NCT00553475|147225701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.||||0.153
73959624|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.7973|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.7973
73959625|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.6348|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.6348
73959626|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.5742|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.5742
73959627|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6719|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.6719
73838362|NCT00553475|147225701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.||||0.059
73959628|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.13||0.0881|ONE_SIDED|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.04|0.0881
73959629|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.2772|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2772
73838363|NCT00553475|147225702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.0287||95.0|-0.82|-0.05|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-0.82|0.0287
73838364|NCT00553475|147225702|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.75||||0.0073||95.0|-1.29|-0.2|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.20|-1.29|0.0073
73838365|NCT00553475|147225703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.0021||95.0|-1.0|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.22|-1.00|0.0021
73838366|NCT00553475|147225703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|||<|0.0001||95.0|-1.78|-0.69|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.69|-1.78|<0.0001
73838367|NCT00553475|147225704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0026||95.0|-0.99|-0.21|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.21|-0.99|0.0026
73838368|NCT00553475|147225704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.13|||<|0.0001||95.0|-1.69|-0.58|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.58|-1.69|<0.0001
73838369|NCT00553475|147225705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0012||95.0|-1.03|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-1.03|0.0012
73838370|NCT00553475|147225705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11|||<|0.0001||95.0|-1.67|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.67|<0.0001
73838371|NCT00553475|147225706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.0011||95.0|-1.04|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.04|0.0011
73838372|NCT00553475|147225706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|||<|0.0001||95.0|-1.72|-0.6|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.60|-1.72|<0.0001
73838373|NCT00553475|147225707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|||<|0.0001||95.0|-1.18|-0.4|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.40|-1.18|<0.0001
73838374|NCT00553475|147225707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.12|||<|0.0001||95.0|-1.68|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.68|<0.0001
73838375|NCT00553475|147225708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.12|0.0003
73959630|NCT00430300|147454768|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.11||0.1363|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1363
73838376|NCT00553475|147225708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.09||||0.0002||95.0|-1.66|-0.52|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.66|0.0002
73838377|NCT00553475|147225709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67||||0.0008||95.0|-1.07|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.07|0.0008
73838378|NCT00553475|147225709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94||||0.0014||95.0|-1.51|-0.36|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.36|-1.51|0.0014
73838379|NCT00553475|147225710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.12|0.0003
73838380|NCT00553475|147225710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.0036||95.0|-1.44|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.44|0.0036
73838381|NCT00553475|147225711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0005||95.0|-1.1|-0.31|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.31|-1.10|0.0005
73838382|NCT00553475|147225711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87||||0.0034||95.0|-1.46|-0.29|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.29|-1.46|0.0034
73838383|NCT00553475|147225712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62||||0.0023||95.0|-1.02|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.22|-1.02|0.0023
73838384|NCT00553475|147225712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.0105||95.0|-1.36|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.36|0.0105
73838385|NCT00553475|147225713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.0016||95.0|-1.05|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-1.05|0.0016
73838386|NCT00553475|147225713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.0111||95.0|-1.37|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.37|0.0111
73838387|NCT00553475|147225714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.07||||0.6118||95.0|-5.23|3.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.08|-5.23|0.6118
73838388|NCT00553475|147225714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.59||||0.0109||95.0|1.76|13.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.42|1.76|0.0109
73838389|NCT00553475|147225715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.49||||0.4602||95.0|-2.47|5.45|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.45|-2.47|0.4602
73838390|NCT00553475|147225715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.97||||0.1625||95.0|-1.61|9.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.54|-1.61|0.1625
73959631|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.1||0.0938|ONE_SIDED|95.0|-0.03||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.03|0.0938
73838391|NCT00553475|147225716|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.25|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.25|<0.0001
73838392|NCT00553475|147225716|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.0273||95.0|-1.19|-0.07|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.07|-1.19|0.0273
73838393|NCT00553475|147225717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.79||||0.0013||95.0|-2.87|-0.71|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.71|-2.87|0.0013
73838394|NCT00553475|147225717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.13||||0.0062||95.0|-3.65|-0.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.61|-3.65|0.0062
73898448|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.331||0.103|TWO_SIDED|95.0|-1.191|0.109||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.109|-1.191|0.103
73838395|NCT00553475|147225718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0068||95.0|-1.03|-0.17|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.03|0.0068
73838396|NCT00553475|147225718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56||||0.0707||95.0|-1.17|0.05|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.05|-1.17|0.0707
73838397|NCT00553475|147225719|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.35||||0.0013||95.0|-3.76|-0.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.93|-3.76|0.0013
73838398|NCT00553475|147225719|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.67||||0.0087||95.0|-4.67|-0.68|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.68|-4.67|0.0087
73838399|NCT00553475|147225720|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.27||||0.0056||95.0|-12.4|-2.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.14|-12.40|0.0056
73959632|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.2149|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.2149
73838400|NCT00553475|147225720|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.49||||0.0427||95.0|-14.74|-0.25|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-14.74|0.0427
73838401|NCT00553475|147225721|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.0365||95.0|-0.4|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.01|-0.40|0.0365
73838402|NCT00553475|147225721|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37||||0.0073||95.0|-0.65|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-0.65|0.0073
73838403|NCT00553475|147225722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.37||||0.0019||95.0|-10.38|-2.36|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.36|-10.38|0.0019
73838404|NCT00553475|147225722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.78||||0.1907||95.0|-9.45|1.89|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.89|-9.45|0.1907
73838405|NCT00553475|147225723|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.9905||95.0|-5.37|5.43|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.43|-5.37|0.9905
73838406|NCT00553475|147225723|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.44||||0.2532||95.0|-3.19|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.08|-3.19|0.2532
73838407|NCT00553475|147225724|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39||||0.4538||95.0|-5.05|2.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.26|-5.05|0.4538
73838408|NCT00553475|147225724|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.84||||0.2782||95.0|-7.97|2.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.30|-7.97|0.2782
73838409|NCT00553475|147225725|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32||||0.0177||95.0|0.06|0.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.59|0.06|0.0177
73838410|NCT00553475|147225725|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17||||0.3661||95.0|-0.2|0.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.55|-0.20|0.3661
73838411|NCT00553475|147225726|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.62||||0.0511||95.0|-0.03|11.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.26|-0.03|0.0511
73838412|NCT00553475|147225726|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.65||||0.0173||95.0|1.72|17.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.59|1.72|0.0173
73838413|NCT00553475|147225727|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.79||||0.1123||95.0|-0.89|8.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.47|-0.89|0.1123
73838414|NCT00553475|147225727|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.79||||0.0206||95.0|1.2|14.38|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||14.38|1.20|0.0206
73838415|NCT00553475|147225728|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.54||||0.0269||95.0|-6.67|-0.41|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.41|-6.67|0.0269
73838416|NCT00553475|147225728|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.82||||0.4183||95.0|-6.24|2.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.60|-6.24|0.4183
73970966|NCT05139810|147481975|SUPERIORITY||Odds Ratio (OR)|11.79|||=|0.003|TWO_SIDED|95.0|2.34|59.36|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.||||59.36|2.34|=0.003
73838417|NCT00553475|147225729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0148
73838418|NCT00553475|147225729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0063
73838419|NCT00553475|147225730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0818||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0818
73838420|NCT00553475|147225730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0075||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0075
73838421|NCT00553475|147225731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.0013||95.0|-1.07|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.07|0.0013
73838422|NCT00553475|147225731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.0152||95.0|-1.34|-0.14|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.14|-1.34|0.0152
73838423|NCT02931539|147225753|SUPERIORITY||Difference in percentage of responders|32.8|||<|0.001|TWO_SIDED|95.0|22.8|42.74|||Cochran-Mantel-Haenszel|||||42.74|22.80|<0.001
73838424|NCT02931539|147225754|SUPERIORITY||Difference in percentage of responders|9.5||||0.013|TWO_SIDED|95.0|2.02|16.88|||Cochran-Mantel-Haenszel|||||16.88|2.02|0.013
73838425|NCT02931539|147225769|OTHER||Hazard Ratio (HR)|1.14||||0.647|TWO_SIDED|95.0|0.549|2.357|||Log Rank|Two-sided p-value comparing treatment groups was calculated from the log rank test by Kaplan-Meier Method.|Stratified Cox regression model was used as transplant type and baseline plasma CMV DNA level as stratification factors.|||2.357|0.549|0.647
73838426|NCT02059642|147225779|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.1||||0.1358|TWO_SIDED|95.0|-4.87|0.66|||Mixed Models Analysis|MMRM: Model of Repeated Measures||||0.66|-4.87|0.1358
73838427|NCT03681093|147225790|SUPERIORITY||Least Squares (LS) Mean|0.05|STANDARD_ERROR_OF_MEAN|0.323||0.979|TWO_SIDED|95.0|-0.59|0.7||Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.|Mixed Model for Repeated Measures (MMRM)|||||0.70|-0.59|0.979
73838428|NCT03681093|147225790|SUPERIORITY||LS Mean|-0.25|STANDARD_ERROR_OF_MEAN|0.319||0.656|TWO_SIDED|95.0|-0.88|0.39||Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.|MMRM|||||0.39|-0.88|0.656
73838429|NCT03681093|147225791|SUPERIORITY||LS Mean|0.64|STANDARD_ERROR_OF_MEAN|0.249||0.012|TWO_SIDED|95.0|0.15|1.14||Unadjusted p-value|MMRM|||||1.14|0.15|0.012
73838430|NCT03681093|147225791|SUPERIORITY||LS Mean|0.45|STANDARD_ERROR_OF_MEAN|0.248||0.074|TWO_SIDED|95.0|-0.04|0.94||Unadjusted p-value|MMRM|||||0.94|-0.04|0.074
73838431|NCT03681093|147225792|SUPERIORITY||LS Mean|5.22|STANDARD_ERROR_OF_MEAN|4.881||0.288|TWO_SIDED|95.0|-4.49|14.93||Unadjusted p-value|MMRM|||||14.93|-4.49|0.288
73838432|NCT03681093|147225792|SUPERIORITY||LS Mean|-2.17|STANDARD_ERROR_OF_MEAN|4.936||0.661|TWO_SIDED|95.0|-11.99|7.65||Unadjusted p-value|MMRM|||||7.65|-11.99|0.661
73838433|NCT03681093|147225793|SUPERIORITY||LS Mean|0.61|STANDARD_ERROR_OF_MEAN|1.809||0.735|TWO_SIDED|95.0|-2.98|4.21||Unadjusted p-value|MMRM|||||4.21|-2.98|0.735
73838434|NCT03681093|147225793|SUPERIORITY||LS Mean|4.51|STANDARD_ERROR_OF_MEAN|1.821||0.015|TWO_SIDED|95.0|0.89|8.13||Unadjusted p-value|MMRM|||||8.13|0.89|0.015
73838435|NCT05033561|147225794|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
73838436|NCT05033561|147225794|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
73838437|NCT05033561|147225795|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
73838438|NCT05033561|147225795|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
73838439|NCT02935036|147225816|SUPERIORITY||LS Mean Difference|1.33||||0.5947|TWO_SIDED||||||ANOVA|||||||0.5947
73838440|NCT02935036|147225817|SUPERIORITY||LS Mean Difference|2.75||||0.2912|TWO_SIDED||||||ANOVA|||||||0.2912
73838441|NCT02935036|147225818|SUPERIORITY||Percent difference|2.4||||0.692|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6920
73838442|NCT06844812|147225826|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|paired t-test||||||<0.001
73838443|NCT06844812|147225827|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|paired t-test||||||0.021
73838444|NCT06844812|147225828|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|paired t-test||||||0.003
73838445|NCT06844812|147225829|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73838446|NCT06844812|147225830|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73838447|NCT00368849|147225843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.63|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.63
73838448|NCT00368849|147225844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.09|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.09
73838449|NCT00368849|147225845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26||||0.46|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.46
73838450|NCT00368849|147225846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.84|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.84
73838451|NCT00368849|147225847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.76|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.76
73838452|NCT02006836|147225848|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 1 sided|||H0: GI of pomelo for diabetic patients - GI of pomelo for healthy people = 0 H1: GI of pomelo for diabetic patients - GI of pomelo for healthy people \> 0 α=5%||||0.005
73838453|NCT02006836|147225849|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after breakfast- ∆g before breakfast = 0 H1：∆g after breakfast- ∆g before breakfast \> 0 α=5%~* g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.~* g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast."||||>0.05
73838454|NCT02006836|147225850|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after lunch - ∆g before lunch = 0 H1：∆g after lunch - ∆g before lunch \> 0 α=5%~* g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch.~* g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch."||||>0.05
73838455|NCT02006836|147225851|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after dinner- ∆g before dinner = 0 H1：∆g after dinner- ∆g before dinner \> 0 α=5%~* g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner.~* g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner."||||>0.05
73838456|NCT02006836|147225852|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||H0: AUC||||>0.05
73838457|NCT05058456|147225860|OTHER|The primary safety hypothesis is: H0: ΠS \> PGS vs. HA: ΠS ≤ PGS where ΠS is the proportion of patients who experience a MAE within 30 days of procedure and PGS is the Safety Performance Goal. All subjects in whom a Mini S IVL catheter was introduced into the vasculature will be included in the analysis (i.e., it is an intent-to-treat analysis). The hypothesis will be tested using a one-sided Exact Binomial Test at α=0.025.|||||<|0.025|||||||Fisher Exact|||||||<.025
73838458|NCT05058456|147225861|OTHER|The primary effectiveness hypothesis is: H0: ΠE ≤ PGE vs. HA: ΠE \> PGE, where ΠE is the proportion of target lesions with technical success and PG is the effectiveness Performance Goal. One-sided statistical significance level of 0.025 = α. The hypothesis will be tested using a one-sided Exact Binomial Test.|||||<|0.025|||||||Fisher Exact|||||||<.025
73838459|NCT01866150|147225873|SUPERIORITY_OR_OTHER||Treatment Difference|1.2||||0.8222|TWO_SIDED|95.0|-9.5|12.0|||Pearson's chi-squared|||A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||12.0|-9.5|0.8222
73838460|NCT01866150|147225874|SUPERIORITY_OR_OTHER||Treatment Difference|3.7||||0.4727|TWO_SIDED|95.0|-6.2|13.6|||Pearson's chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||13.6|-6.2|0.4727
73838461|NCT01866150|147225874|SUPERIORITY_OR_OTHER||Treatment Difference|2.6||||0.6349|TWO_SIDED|95.0|-8.0|13.1|||Pearson's chi-squared|||Comparison at last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||13.1|-8.0|0.6349
73838462|NCT01866150|147225875|SUPERIORITY_OR_OTHER||Slope|-0.9||||0.8769|TWO_SIDED|95.0|-12.1|10.4|||Pearson's chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||10.4|-12.1|0.8769
73838463|NCT01866150|147225875|SUPERIORITY_OR_OTHER||Treatment Difference|3.4||||0.5649|TWO_SIDED|95.0|-8.2|15.0|||Pearson's chi-squared|||Comparison at Month 6. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||15.0|-8.2|0.5649
73838464|NCT01866150|147225875|SUPERIORITY_OR_OTHER||Treatment Difference|9.9||||0.0556|TWO_SIDED|95.0|-0.3|20.2|||Pearson's chi-squared|||Comparison at the last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||20.2|-0.3|0.0556
73838465|NCT01866150|147225876|SUPERIORITY_OR_OTHER||Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.152||0.5195|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Comparison at Month 3. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.20|-0.40|0.5195
73838466|NCT01866150|147225876|SUPERIORITY_OR_OTHER||Treatment difference|-0.17|STANDARD_ERROR_OF_MEAN|0.149||0.242|TWO_SIDED|95.0|-0.47|0.12|||Mixed Models Analysis|||Comparison at Month 6. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.12|-0.47|0.2420
73898449|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|2.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73838467|NCT01866150|147225876|SUPERIORITY_OR_OTHER||Treatment difference|-0.15|STANDARD_ERROR_OF_MEAN|0.154||0.3264|TWO_SIDED|95.0|-0.45|0.15|||Mixed Models Analysis|||Comparison at the last visit. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.15|-0.45|0.3264
73838468|NCT01866150|147225878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.81||||0.0237|TWO_SIDED|95.0|-16.44|-1.18|||General Linear Model|||Analysis was performed using a general linear model with cohort as a factor.||-1.18|-16.44|0.0237
73838469|NCT02722330|147225897|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||||||<0.0001
73838470|NCT02722330|147225898|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Ease of communication||||<0.0001
73838471|NCT02722330|147225898|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Reverberation||||<0.0001
73838472|NCT02722330|147225898|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Background noise||||<0.0001
73838473|NCT02722330|147225898|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wilcoxon Signed rank Test|||Aversiveness||||0.0004
73838474|NCT02722330|147225898|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Global score||||<0.0001
73838475|NCT02722330|147225899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech scale||||<0.0001
73838476|NCT02722330|147225899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Spatial scale||||<0.0001
73838477|NCT02722330|147225899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Qualities scale||||<0.0001
73838478|NCT02722330|147225900|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||||||<0.0001
73838479|NCT02722330|147225901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz||||<0.0001
73838480|NCT02722330|147225901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz||||<0.0001
73838481|NCT02722330|147225901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz||||<0.0001
73838482|NCT02722330|147225901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz||||<0.0001
73838483|NCT02722330|147225901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz||||<0.0001
73838484|NCT02722330|147225901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz||||<0.0001
73838485|NCT02722330|147225901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz||||<0.0001
73838486|NCT02722330|147225901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz||||<0.0001
73838487|NCT02722330|147225901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz||||<0.0001
73838488|NCT02722330|147225902|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz||||<0.0001
73838489|NCT02722330|147225902|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz||||<0.0001
73838490|NCT02722330|147225902|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz||||<0.0001
73838491|NCT02722330|147225902|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz||||<0.0001
73838492|NCT02722330|147225902|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz||||<0.0001
73838493|NCT02722330|147225902|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz||||<0.0001
73838494|NCT02722330|147225902|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz||||<0.0001
73838495|NCT02722330|147225902|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz||||<0.0001
73838496|NCT02722330|147225902|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz||||<0.0001
73838497|NCT02722330|147225903|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon Signed Rank test|||||||0.002
73838498|NCT02722330|147225904|SUPERIORITY_OR_OTHER|||||||0.0024|||||||Wilcoxon Signed Rank test|||||||0.0024
73838499|NCT02722330|147225905|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 50 dB||||<0.0001
73838500|NCT02722330|147225905|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB||||<0.0001
73838501|NCT02722330|147225905|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB||||<0.0001
73838502|NCT02722330|147225906|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All variable had the same p value (\<0.0001).|Wolcoxon Signed rank test|||Speech Presentation Level 50 dB||||<0.0001
73838503|NCT02722330|147225906|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB||||<0.0001
73838504|NCT02722330|147225906|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB||||<0.0001
73838505|NCT02722330|147225907|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon Signed Rank test|||||||0.036
73838506|NCT02722330|147225908|SUPERIORITY_OR_OTHER|||||||0.065|||||||Wilcoxon Signed Rank test|||||||0.065
73838507|NCT02722330|147225909|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon Signed Rank test|||250 Hz||||0.47
73838508|NCT02722330|147225909|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon Signed Rank test|||500 Hz||||0.16
73838509|NCT02722330|147225909|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon Signed Rank test|||750 Hz||||0.59
73838510|NCT02722330|147225909|SUPERIORITY_OR_OTHER|||||||0.034|||||||Wilcoxon Signed Rank test|||1000 Hz||||0.034
73838511|NCT02722330|147225909|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon Signed Rank test|||1500 Hz||||0.25
73838512|NCT02722330|147225909|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon Signed Rank test|||2000 Hz||||0.023
73838513|NCT02722330|147225909|SUPERIORITY_OR_OTHER|||||||0.028|||||||Wilcoxon Signed Rank test|||3000 Hz||||0.028
73838514|NCT02722330|147225909|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Wilcoxon Signed Rank test|||4000 Hz||||0.0075
73838515|NCT02722330|147225909|SUPERIORITY_OR_OTHER|||||||0.0035|||||||Wilcoxon Signed Rank test|||6000 Hz||||0.0035
73838516|NCT02722330|147225910|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon Signed Rank test|||250 Hz||||0.12
73838517|NCT02722330|147225910|SUPERIORITY_OR_OTHER|||||||0.072|||||||Wilcoxon Signed Rank test|||500 Hz||||0.072
73838518|NCT02722330|147225910|SUPERIORITY_OR_OTHER|||||||0.56|||||||Wilcoxon Signed Rank test|||750 Hz||||0.56
73838519|NCT02722330|147225910|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon Signed Rank test|||1000 Hz||||0.16
73838520|NCT02722330|147225910|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon Signed Rank test|||1500 Hz||||0.39
73838521|NCT02722330|147225910|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon Signed Rank test|||2000 Hz||||0.11
73838522|NCT02722330|147225910|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon Signed Rank test|||3000 Hz||||0.38
73838523|NCT02722330|147225910|SUPERIORITY_OR_OTHER|||||||0.014|||||||Wilcoxon Signed Rank test|||4000 Hz||||0.014
73838524|NCT02722330|147225910|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon Signed Rank test|||6000 Hz||||0.71
73838525|NCT02722330|147225911|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon Signed Rank test|||||||0.48
73838526|NCT02722330|147225912|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon Signed Rank test|||||||0.11
73838527|NCT02722330|147225913|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon Signed Rank test|||SPL 50 dB||||0.017
73838528|NCT02722330|147225913|SUPERIORITY_OR_OTHER|||||||0.095|||||||Wilcoxon Signed Rank test|||SPL 65 dB||||0.095
73838529|NCT02722330|147225913|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon Signed Rank test|||SPL 80 dB||||0.57
73838530|NCT02722330|147225914|SUPERIORITY_OR_OTHER|||||||0.096|||||||Wilcoxon Signed Rank test|||SPL 50 dB||||0.096
73838531|NCT02722330|147225914|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon Signed Rank test|||SPL 65 dB||||1.00
73838532|NCT02722330|147225914|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon Signed Rank test|||SPL 80 dB||||0.41
73838533|NCT04392362|147225920|NON_INFERIORITY|The non-inferiority margin or delta was calculated as -0.12(-12%)|Risk Ratio (RR)|0.89||||0.8982|ONE_SIDED|95.0||||0.05 was the level of significance|Wilcoxon (Mann-Whitney)|||The null hypothesis is that the AHA method is inferior to the SIM method but not lower than a pre calculated noninferiority delta of -0.12 (-12 %) and a 95% one sided confidence interval. Only 33 (instead of 151 for a power of 95%) patients could be enrolled with 25 in the SIM and 8 in the AHA arms, which resulted in an estimated power test of 59.08%.||||0.8982
73838534|NCT01934231|147225921|SUPERIORITY_OR_OTHER||Rate of Cure|88.5|||||TWO_SIDED|95.0|69.85|97.55|||||"The estimated parameter represents the rate of cure, calculated as (number of participants with an outcome of Cure/number of participants analyzed) \* 100."|||97.55|69.85|
73838535|NCT00382863|147225936|SUPERIORITY_OR_OTHER|||||||0.502|||||||Fisher Exact|One-sided||Null hypothesis = proportion of subjects in treatment group who successfully achieved an improvement of at least 1.0 ml/kg/min at 6 months is less than or equal to the Control group. Subjects who withdrew for cardiac-related reasons were classified as non-responders.||||0.502
73838536|NCT00382863|147225937|SUPERIORITY_OR_OTHER|||||||0.044|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of subjects in the treatment group who successfully achieved an improvement of at least 45 m at 6 months from baseline is less than or equal to that of the Control group. Withdrawals due to cardiac reasons are counted as non-responders.||||0.044
73838537|NCT00382863|147225938|SUPERIORITY_OR_OTHER|||||||0.184|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of treatment subjects who successfully achieved an improvement of at least 7 points at 6 months is equal to or less than that of the control group. Withdrawals due to cardiac reasons are counted as non-responders.||||0.184
73838538|NCT00382863|147225939|NON_INFERIORITY_OR_EQUIVALENCE|Estimated survival for the treatment group was 93%. Estimated survival for the control group was 91.5%. A non-inferiority margin of 7.5%. Final test alpha level of 0.04825.||||||0.012|||||||Exact binomial test|One-sided||The null hypothesis = survival in the treatment group at 12 months is not equivalent to that of the Control group.||||0.012
73838539|NCT00382863|147225940|SUPERIORITY_OR_OTHER|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||Class change from baseline.||||0.052
73838540|NCT00382863|147225941|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73838541|NCT00382863|147225942|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.032
73838542|NCT00382863|147225943|SUPERIORITY_OR_OTHER|||||||0.54|||||||Fisher Exact|One-sided||Improvement of at least 1.0 ml/kg/min from baseline.||||0.540
73838543|NCT00382863|147225944|SUPERIORITY_OR_OTHER|||||||0.067|||||||Fisher Exact|One-sided||Improvement of at least 45 m from baseline.||||0.067
73838544|NCT00382863|147225945|SUPERIORITY_OR_OTHER|||||||0.031|||||||Fisher Exact|One-sided||Improvement of at least 7 points from baseline.||||0.031
73838545|NCT00382863|147225946|SUPERIORITY_OR_OTHER|||||||0.109|||||||Log Rank|||Kaplan-Meier actuarial time-to-first-event analysis||||0.109
73838546|NCT00382863|147225947|SUPERIORITY_OR_OTHER|||||||0.031|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.031
73838547|NCT00382863|147225948|SUPERIORITY_OR_OTHER|||||||0.179|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.179
73838548|NCT00382863|147225949|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.070
73838549|NCT00382863|147225950|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.015
73838550|NCT00382863|147225951|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.032
73838551|NCT00382863|147225953|SUPERIORITY_OR_OTHER|||||||0.627|||||||Fisher Exact|Two-sided||||||0.627
73838552|NCT00382863|147225954|SUPERIORITY_OR_OTHER|||||||0.386|||||||Log Rank|||||||0.386
73838553|NCT00382863|147225955|SUPERIORITY_OR_OTHER|||||||0.154|||||||Fisher Exact|Two-sided||||||0.154
73838554|NCT00382863|147225956|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|Two-sided||||||1.000
73838555|NCT00382863|147225957|SUPERIORITY_OR_OTHER|||||||0.939|||||||Log Rank|||||||0.939
73838556|NCT00382863|147225958|SUPERIORITY_OR_OTHER|||||||0.012|||||||Fisher Exact|Two-sided||||||0.012
73838557|NCT00382863|147225959|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
73838558|NCT00382863|147225960|SUPERIORITY_OR_OTHER|||||||0.772|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.772
73838559|NCT02837952|147225981|SUPERIORITY||Least Square Mean Difference|72.89|||<|0.001|TWO_SIDED|95.0|50.075|95.707|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.||95.707|50.075|<0.001
73838560|NCT02837952|147225982|SUPERIORITY||Least Square Mean Difference|26.45|||<|0.001|TWO_SIDED|95.0|19.895|33.005|||ANCOVA|||0 to 8 hours: Treatment difference and 95% CI were based on least square (LS) mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||33.005|19.895|< 0.001
73838561|NCT02837952|147225982|SUPERIORITY||LS Mean Difference|7.91|||<|0.001|TWO_SIDED|95.0|5.196|10.632|||ANCOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.632|5.196|< 0.001
73838562|NCT02837952|147225982|SUPERIORITY||LS Mean Difference|51.67|||<|0.001|TWO_SIDED|95.0|37.075|66.258|||ANCOVA|||0 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||66.258|37.075|< 0.001
73838563|NCT02837952|147225982|SUPERIORITY||LS Mean Difference|27.32|||<|0.001|TWO_SIDED|95.0|18.139|36.508|||ANCOVA|||8 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||36.508|18.139|< 0.001
73838564|NCT02837952|147225982|SUPERIORITY||LS Mean Difference|138.65|||<|0.001|TWO_SIDED|95.0|91.045|186.261|||ANCOVA|||0 to 48 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||186.261|91.045|< 0.001
73838565|NCT02837952|147225983|SUPERIORITY||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test|||||||<0.001
73838566|NCT02837952|147225984|SUPERIORITY||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test|||||||<0.001
73838567|NCT01362530|147225985|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
73838568|NCT01362530|147225986|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.05
73838569|NCT01362530|147225987|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
73838570|NCT01362530|147225988|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
73838571|NCT00215553|147225995|SUPERIORITY_OR_OTHER|||||||0.794||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.794
73838572|NCT00215553|147225995|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.236
73838573|NCT00215553|147225995|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.396
73838574|NCT00215553|147225996|SUPERIORITY_OR_OTHER|||||||0.346||95.0|||||Cochran-Mantel-Haenszel|||||||0.346
73838575|NCT00215553|147225996|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||Cochran-Mantel-Haenszel|||||||0.286
73838576|NCT00215553|147225996|SUPERIORITY_OR_OTHER|||||||0.964||95.0|||||Cochran-Mantel-Haenszel|||||||0.964
73838577|NCT00215553|147225997|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||ANOVA|ANOVA on ranks||||||0.028
73838578|NCT00215553|147225997|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||ANOVA|ANOVA on ranks||||||0.147
73838579|NCT00215553|147225997|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||ANOVA|ANOVA on ranks||||||0.293
73838580|NCT00276380|147226012|OTHER||Odds Ratio (OR)|0.83||||0.52|TWO_SIDED|95.0|0.46|1.48|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.48|0.46|0.52
73838581|NCT00276380|147226013|OTHER|Comparison of treatment effect at Day 28|Odds Ratio (OR)|0.86||||0.623|TWO_SIDED|95.0|0.47|1.57|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.57|0.47|0.623
73838582|NCT00276380|147226013|OTHER|Comparison of treatment effect at Day 84|Odds Ratio (OR)|0.74||||0.3|TWO_SIDED|95.0|0.42|1.3|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.3|0.42|0.3
73838583|NCT00276380|147226015|OTHER|||||||0.207||||||Treatment effect was derived using a parametric analysis of covariance (ANCOVA) with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.207
73838584|NCT00276380|147226015|OTHER|||||||0.59||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.590
73838585|NCT00276380|147226015|OTHER|Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.||||||0.814|||||||ANCOVA|||Comparison of treatment effect at Day 168||||0.814
73838586|NCT00276380|147226016|OTHER|||||||0.24||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.240
73838587|NCT00276380|147226016|OTHER|||||||0.441||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.441
73838588|NCT00276380|147226016|OTHER|||||||0.645||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 168||||0.645
73838589|NCT00276380|147226017|OTHER|||||||0.623||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.623
73838590|NCT00276380|147226017|OTHER|||||||0.338||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.338
73838591|NCT00276380|147226017|OTHER|||||||0.828||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates|ANCOVA|||Comparison of treatment effect at Day 168||||0.828
73838592|NCT04829214|147226029|SUPERIORITY||Risk Difference (RD)|-10.2|STANDARD_ERROR_OF_MEAN|7.9|=|0.385|TWO_SIDED|95.0|-26.0|5.0|||Mantel Haenszel|||The percentage of responders will be compared between the two groups using the Mantel Haenszel test controlling for category of duration of tinnitus and category of baseline TFI overall score. The primary efficacy analysis will be conducted for the comparison of OTO-313 and placebo, using a 2-sided test and an alpha level of 5%. The 95% confidence intervals (CI) around the common risk difference will also be provided.||5|-26|=0.385
73838593|NCT02739828|147226034|SUPERIORITY|||||||0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0001
73838594|NCT02739828|147226035|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||< 0.0001
73838595|NCT02739828|147226036|SUPERIORITY|||||||0.0004|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0004
73838596|NCT02739828|147226037|SUPERIORITY|||||||0.0005|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0005
73838597|NCT02739828|147226037|SUPERIORITY|||||||0.0006|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0006
73838598|NCT02739828|147226038|SUPERIORITY|||||||0.0004|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0004
73838599|NCT02739828|147226038|SUPERIORITY|||||||0.0016|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0016
73838600|NCT02739828|147226039|SUPERIORITY|||||||0.0003|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0003
73838601|NCT02739828|147226039|SUPERIORITY|||||||0.0094|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0094
73838602|NCT02739828|147226043|SUPERIORITY|||||||0.0278|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0278
73838603|NCT02739828|147226044|SUPERIORITY|||||||0.0215|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0215
73838604|NCT02739828|147226045|SUPERIORITY|||||||0.1652|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1652
73838605|NCT02739828|147226049|SUPERIORITY|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||1.0000
73838606|NCT02739828|147226050|SUPERIORITY|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||1.0000
73838607|NCT02739828|147226051|SUPERIORITY|||||||0.5|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.5000
73838608|NCT02739828|147226052|SUPERIORITY|||||||0.1797|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1797
73838609|NCT02739828|147226053|SUPERIORITY|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.4531
73838610|NCT02739828|147226054|SUPERIORITY|||||||0.0313|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0313
73838611|NCT02739828|147226055|SUPERIORITY|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.3438
73838612|NCT02739828|147226056|SUPERIORITY|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.4531
73838613|NCT02739828|147226057|SUPERIORITY|||||||0.0156|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0156
73838614|NCT02739828|147226058|SUPERIORITY|||||||0.0386|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0386
73838615|NCT02739828|147226059|SUPERIORITY|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.3438
73838616|NCT02739828|147226060|SUPERIORITY|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1250
73838617|NCT02739828|147226061|SUPERIORITY|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0625
73838618|NCT02739828|147226062|SUPERIORITY|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0625
73838619|NCT02739828|147226063|SUPERIORITY|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1250
73838620|NCT02571244|147226069|SUPERIORITY||Risk Ratio (RR)|1.35|||||TWO_SIDED|95.0|0.99|1.85||||||||1.85|0.99|
73838621|NCT02571244|147226070|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
73838622|NCT02571244|147226071|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
73838623|NCT02571244|147226072|SUPERIORITY||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|1.08|1.95||||||||1.95|1.08|
73838624|NCT02571244|147226073|SUPERIORITY||Risk Ratio (RR)|1.44|||||TWO_SIDED|95.0|1.07|1.92||||||||1.92|1.07|
73838625|NCT02770365|147226142|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.14|||||TWO_SIDED|90.0|-2.92|12.53|||Wald's method|||||12.53|-2.92|
73838626|NCT02770365|147226143|EQUIVALENCE|the proportion of subjects with treatment success based on the improvement of the Most Bothersome Symptom (MBS) of vulvo-vaginal atrophy at Day 8.|equivalence ratio|0.94||||0.05|TWO_SIDED|90.0|-12.35|4.31|||Wald's method|||||4.31|-12.35|0.05
73838627|NCT03907579|147226160|SUPERIORITY|||||||0.0001|||||||Wilcoxon Signed Rank Test|z= -3.861||||||0.0001
73898450|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.362||0.06|TWO_SIDED|95.0|-1.396|0.028||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.028|-1.396|0.060
73838628|NCT03319654|147226194|OTHER|A generalized estimating equation (GEE)-model with an exchangeable correlation structure and a logit link function was used to analyze the probability of live birth and clinical pregnancy respectively. All IUI cycles are used in this model with correction for the fact that cycles of the same couple are not independent.|Odds Ratio (OR)|0.94||||0.04|TWO_SIDED|95.0|0.9|0.9985|||GEE-model|||The null hypothesis is: there is no association between % total Sperm DNA Fragmentation and live birth.||0.9985|0.90|0.04
73838629|NCT03319654|147226194|OTHER||Area under the ROC curve|0.576|||>|0.05|TWO_SIDED||||||Receiver Operating Characteristics curve|||||||>0.05
73838630|NCT04128228|147226201|OTHER|"Single group: All individuals with alcohol use disorder received the same treatment.~Brain responses were examined at baseline in individuals with alcohol use disorder (AUD) with and without early trauma (AUD/ET, AUD/NT), as well as in moderate drinkers (MD) with and without early trauma (MD/ET, MD/NT)."|F value for the 2 X 2 Group Interaction|5.5|||<|0.05|TWO_SIDED|||||A 2 × 2 × 3 Linear Mixed Model was conducted with Early Trauma Group (ET, NT) and Drinking Group (AUD, MD) as between-subjects factors, and Condition (stress, alcohol, neutral) as the within-subjects factor.|Linear Mixed Model|||A regions of interest (ROI) analysis was conducted to evaluate brain activity in the right ventromedial prefrontal cortex (VmPFC, BA10), a region identified a priori. The VmPFC ROI was defined using the Yale-Brodmann atlas in the BioImage Suite application, from which the beta value for the VmPFC ROI was obtained for a Linear Mixed Model analysis.||||<0.05
73838631|NCT04128228|147226202|OTHER|Single group (all individuals with alcohol use disorder received the same treatment). Hormone responses were examined at baseline in individuals with alcohol use disorder (AUD) with and without early trauma (AUD/ET, AUD/NT), as well as in moderate drinkers (MD) with and without early trauma (MD/ET, MD/NT).|F value|4.79|||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
73838632|NCT04128228|147226203|OTHER|Single Group|Hazard Ratio (HR)|0.71|||<|0.05|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|||||.95|.53|<0.05
73838633|NCT04128228|147226204|OTHER|Single Group. All individuals with alcohol use disorder received the same treatment.|t value|-3.35|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
73838634|NCT04128228|147226205|OTHER|Single Group (All individuals with alcohol use disorder received the same treatment.)|t value|-2.6|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73838635|NCT03000166|147226213|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
73838636|NCT03000166|147226214|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
73838637|NCT03000166|147226215|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
73838638|NCT03000166|147226216|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
73838639|NCT04565756|147226241|OTHER|||||||||||||||||Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables. All statistical analyses were descriptive in nature and any statistical inferences were carried out according to the analysis plan and interpreted in view of the exploratory nature of the study.|Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables.|||
73838640|NCT05226884|147226249|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
73838641|NCT05226884|147226250|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
73838642|NCT05226884|147226251|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
73838643|NCT05226884|147226252|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||||||||||||||The defocus curve is generated based on measurements over a dioptric range.|||
73838644|NCT05226884|147226253|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
73838645|NCT03782103|147226273|NON_INFERIORITY|Investigational product upper bounds must be less than 0.5.|Median Difference (Final Values)|-0.2845|||||TWO_SIDED|95.0|-0.6033|0.0334||||||Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.0334|-0.6033|
73838646|NCT03782103|147226273|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|2.8535|||||TWO_SIDED|95.0|2.5415|3.1655||||||Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||3.1655|2.5415|
73838647|NCT03782103|147226274|NON_INFERIORITY|Investigational product average treatment effect upper bounds cannot be more than 0.5.|Mean Difference (Final Values)|0.0577|||||TWO_SIDED|95.0|-0.1457|0.2611||||||Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.2611|-0.1457|
73838648|NCT03782103|147226274|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|1.8208|||||TWO_SIDED|95.0|1.6153|2.0264||||||Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.0264|1.6153|
73838649|NCT00954538|147226320|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73838650|NCT00954538|147226321|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|||||TWO_SIDED|90.0|-0.04|0.27|||Linear Fixed Effects Model||Difference = AD group value - HE group value|A 90% confidence interval was calculated for the group difference (AD - HE) using the model results. As prespecified by the analysis plan, if the lower bound of the 90% confidence interval is above 0, then the hypothesis that \[18F\]MK-3328 can discriminate between AD patients and cognitively normal elderly controls as measured by regional tracer uptake following single IV doses of \[18F\]MK-3328 is supported.||0.27|-0.04|
73838651|NCT03061214|147226358|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.70|-1.00|<.0001
73838652|NCT03061214|147226358|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.36|-0.66|<.0001
73838653|NCT03061214|147226358|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.70|-1.00|<.0001
73838654|NCT03061214|147226358|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.36|-0.66|<.0001
73838655|NCT03211858|147226470|NON_INFERIORITY|Non-inferiority of SAR341402 over NovoLog/NovoRapid was demonstrated if upper bound of the 2-sided 95% confidence interval (CI) of the difference between SAR341402 and NovoLog/NovoRapid was \<0.3%. If non-inferiority was demonstrated, using a hierarchical step down testing procedure, the inverse non-inferiority of NovoLog/NovoRapid over SAR341402 was tested and was demonstrated if lower bound of the 2-sided 95% CI of the difference between SAR341402 and NovoLog/NovoRapid was \> -0.3%.|LS Mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.192|0.039|||||SAR341402 vs NovoLog/NovoRapid|Analysis was performed using ANCOVA with treatment group (SAR341402, NovoLog/NovoRapid), the randomization strata of geographical region, type of diabetes and prior use of NovoLog/NovoRapid as fixed categorical effects, as well as the continuous fixed covariate of baseline HbA1c value.||0.039|-0.192|
73838656|NCT00600704|147226489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.379|STANDARD_DEVIATION|0.096|<|0.05|TWO_SIDED|95.0|0.189|0.569|||t-test, 2 sided|||Sample size calculation was based on a two-sided alpha error of .05 and 80% power. After applying the protocol in two equal groups of 10 patients, the analysis showed that the study requires 60 patients per group. However, we decided to enroll up to 100 patients per group to allow for patient attrition or missing data, and also in order to look for differences with regards to transfusion between patient subgroups.||0.569|0.189|<0.05
73838657|NCT00600704|147226489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.797|STANDARD_ERROR_OF_MEAN|0.168|<|0.05|TWO_SIDED|95.0|0.465|1.129|||Regression, Linear||The mean difference between groups B and A is adjusted for age, gender, BMI and preoperative HCT, while BSA, weight, height, postoperative HCT were not included in the final model to avoid collinearity.|Null hypothesis :restrictive fluid protocol does not have any effect concerning the mean number of PRC units transfused.||1.129|0.465|<0.05
73838658|NCT01423084|147226533|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against H44/76 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|1.0|||||TWO_SIDED|95.0|0.82|1.23||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against H44/76 strain||1.23|0.82|
73838659|NCT01423084|147226533|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against 5/99 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.92|||||TWO_SIDED|95.0|0.77|1.1||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against 5/99 strain||1.1|0.77|
73838660|NCT01423084|147226533|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against NZ 98/254 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.81|||||TWO_SIDED|95.0|0.6|1.09||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against NZ98/254 strain||1.09|0.6|
73898451|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|-0.22|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73959633|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.09||0.1682|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1682
73959634|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.1||0.4492|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.4492
73838661|NCT01423084|147226541|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of ELISA GMCs against vaccine antigen 287-953 if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.83|||||TWO_SIDED|95.0|0.67|1.02||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs||1.02|0.67|
73838662|NCT03707821|147226597|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|3.3|STANDARD_DEVIATION|2.65|||TWO_SIDED|95.0|-2.0|8.5|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 5 points difference in mean overall comfort at he 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||8.5|-2.0|
73838663|NCT03707821|147226598|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 2 was used. This margin is based on a 10% difference if the proportion of subjects that report a higher rating/experience.|Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|0.034|||TWO_SIDED|95.0|0.02|0.15|||Bayesian random -effects model|A 95% Credible Interval for the Posterior proportion mean difference between the Test and Control was used to test for non-inferiority.|mean difference was calculated as Test minus Control.|It was calculated that 40 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 10% difference in proportion of subjects that reported at higher rating (Strongly Agree and Agree) with the Test compared to the Control lens at the 2-week follow-up. Sample size was determined using simulation-based methods (alpha=0.05).||0.15|0.02|
73838664|NCT03707821|147226599|NON_INFERIORITY|A non-inferiority margin of 0.05 points was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.008|||TWO_SIDED|95.0|-0.04|-0.01|||Bayesian Normal Random effects model|A 95% Credible Interval for the Posterior mean difference between the Test and control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.||-0.01|-0.04|
73838665|NCT03707821|147226600|SUPERIORITY|A superiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|Mean Percentage of Acceptable Fitting|99.5|STANDARD_DEVIATION|0.38|||TWO_SIDED|95.0|98.5|100.0|||Bayesian Beta-Binomial Model|model for correlated data||It was calculated that 100 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.||100|98.5|
73838666|NCT03707821|147226601|NON_INFERIORITY|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0036|||TWO_SIDED|95.0|-0.007|0.008|||Bayesian beta-binomial model|model for correlated data|mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.||0.008|-0.007|
73838667|NCT03707821|147226602|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|2.5|STANDARD_DEVIATION|1.94|||TWO_SIDED|95.0|-1.3|6.3|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.||6.3|-1.3|
73959635|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.2539|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.2539
73838668|NCT03707821|147226603|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|8.03|STANDARD_DEVIATION|2.295|||TWO_SIDED|95.0|3.48|12.54|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.||12.54|3.48|
73838669|NCT00159874|147226657|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.02|STANDARD_ERROR_OF_MEAN|6.1||0.253|TWO_SIDED|95.0|-19.13|5.09|||ANCOVA||Least square mean difference of -7.02 was calculated as ' Sildenafil Medium Dose - Low Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||5.09|-19.13|0.253
73838670|NCT00159874|147226657|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.84|STANDARD_ERROR_OF_MEAN|5.92||0.1|TWO_SIDED|95.0|-21.6|1.93|||ANCOVA||Least square mean difference of -9.84 was calculated as ' Sildenafil High Dose - Low Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||1.93|-21.60|0.100
73838671|NCT00159874|147226657|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.82|STANDARD_ERROR_OF_MEAN|6.01||0.64|TWO_SIDED|95.0|-14.75|9.11|||ANCOVA||Least square mean difference of -2.82 was calculated as ' Sildenafil High Dose - Medium Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||9.11|-14.75|0.640
73838672|NCT04019704|147226674|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
73898452|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.36||0.091|TWO_SIDED|95.0|-1.316|0.098||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.098|-1.316|0.091
73838673|NCT05122143|147226675|SUPERIORITY|||||||0.0085||||||Treatment D (A+B) versus Treatment C|ANCOVA|||"Treatment A + B were pooled to Treatment D for the Primary endpoint. The primary objective was to compare the efficacy of the AM-301 nasal spray (treatment D= A+B) and no treatment (C) in reducing nasal symptoms induced from HDM allergen exposure.~The TNSS value from the baseline exposure (at screening exposure visit 2) was subtracted from the TNSS value of the treatment exposure to obtain change from baseline. A lower value resembles less symptoms."||||0.0085
73838674|NCT02662582|147226758|SUPERIORITY||LSMean difference|-12.0||||0.734|TWO_SIDED|90.0|-71.2|47.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Least square means (LSMeans), LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||47.2|-71.2|0.734
73838675|NCT02662582|147226759|SUPERIORITY||LSMean Difference|-0.0219||||0.438|TWO_SIDED|90.0|-0.0694|0.0256||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0256|-0.0694|0.438
73838676|NCT02662582|147226759|SUPERIORITY||LSMean Difference|-0.0325||||0.114|TWO_SIDED|90.0|-0.0663|0.0014||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0014|-0.0663|0.114
73838677|NCT02662582|147226760|SUPERIORITY||LSMean difference|0.75||||0.612|TWO_SIDED|90.0|-1.75|3.24||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||3.24|-1.75|0.612
73838678|NCT02662582|147226760|SUPERIORITY||LSMean difference|0.29||||0.789|TWO_SIDED|90.0|-1.55|2.14||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||2.14|-1.55|0.789
73838679|NCT02662582|147226761|SUPERIORITY||LSMean difference|0.72||||0.225|TWO_SIDED|90.0|-0.26|1.7||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.70|-0.26|0.225
73838680|NCT02662582|147226761|SUPERIORITY||LSMean difference|0.92||||0.064||90.0|0.11|1.174||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.174|0.11|0.064
73838681|NCT02662582|147226762|SUPERIORITY||LSMean difference|0.052||||0.447|TWO_SIDED|90.0|-0.063|0.167||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.167|-0.063|0.447
73838682|NCT02662582|147226763|SUPERIORITY||LSMean difference|-0.8||||0.099|TWO_SIDED|90.0|-1.7|0.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Dyspnea) at Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0|-1.7|0.099
73838683|NCT02662582|147226763|SUPERIORITY||LSMean difference|-0.5||||0.255|TWO_SIDED|90.0|-1.3|0.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Dyspnea) at isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.2|-1.3|0.255
73838684|NCT02662582|147226763|SUPERIORITY||LSMean difference|-0.2||||0.651|TWO_SIDED|90.0|-1.1|0.6||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Leg Effort) at Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.6|-1.1|0.651
73838685|NCT02662582|147226763|SUPERIORITY||LSMean difference|-0.3||||0.591|TWO_SIDED|90.0|-1.0|0.5||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Leg Effort) at isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.5|-1.0|0.591
73838686|NCT02662582|147226764|SUPERIORITY||LSMean difference|0.0286||||0.04|TWO_SIDED|90.0|0.0061|0.0511||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0511|0.0061|0.040
73838687|NCT02662582|147226764|SUPERIORITY||LSMean differencce|0.0185||||0.155|TWO_SIDED|90.0|-0.0031|0.0401||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0401|-0.0031|0.155
73838688|NCT02662582|147226765|SUPERIORITY||LSMean difference|0.001||||0.972|TWO_SIDED|90.0|-0.0459|0.0479||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0479|-0.0459|0.972
73838689|NCT02662582|147226765|SUPERIORITY||LSMean difference|-0.0118||||0.578|TWO_SIDED|90.0|-0.0471|0.0236||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0236|-0.0471|0.578
73838690|NCT02662582|147226766|SUPERIORITY||LSMean difference|-0.65||||0.235|TWO_SIDED|90.0|-1.55|0.26||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.26|-1.55|0.235
73838691|NCT02662582|147226766|SUPERIORITY||LSMean differencce|-0.57||||0.215|TWO_SIDED|90.0|-1.33|0.19||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.19|-1.33|0.215
73838692|NCT02662582|147226767|SUPERIORITY||LSMean difference|0.7||||0.28|TWO_SIDED|90.0|-0.38|1.77||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.77|-0.38|0.280
73838693|NCT02662582|147226767|SUPERIORITY||LSMean difference|0.46||||0.424|TWO_SIDED|90.0|-0.49|1.4||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.40|-0.49|0.424
73838694|NCT02662582|147226768|SUPERIORITY||LSMean difference|0.039||||0.187|TWO_SIDED|90.0|-0.0099|0.0879||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0879|-0.0099|0.187
73838695|NCT02662582|147226768|SUPERIORITY||LSMean difference|0.0488||||0.213|TWO_SIDED|90.0|-0.0163|0.114||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.1140|-0.0163|0.213
73838696|NCT02662582|147226769|SUPERIORITY||LSMean difference|-0.4||||0.64||90.0|-2.1|1.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.2|-2.1|0.640
73838697|NCT02662582|147226769|SUPERIORITY||LSMean difference|-0.7||||0.487|TWO_SIDED|90.0|-2.5|1.1||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.1|-2.5|0.487
73838698|NCT02662582|147226770|SUPERIORITY||LSMean difference|0.095||||0.1|TWO_SIDED|90.0|0.0|0.189||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.189|0.000|0.100
73838699|NCT02662582|147226770|SUPERIORITY||LSMean difference|0.133||||0.008|TWO_SIDED|90.0|0.053|0.213||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.213|0.053|0.008
73838700|NCT02662582|147226771|SUPERIORITY||LSMean difference|0.051||||0.408|TWO_SIDED|90.0|-0.052|0.154||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.154|-0.052|0.408
73838701|NCT02662582|147226771|SUPERIORITY||LSMean difference|0.094||||0.058|TWO_SIDED|90.0|0.013|0.174||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.174|0.013|0.058
73838702|NCT02662582|147226772|SUPERIORITY||LSMean difference|1.44||||0.648|TWO_SIDED|90.0|-3.85|6.73||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||6.73|-3.85|0.648
73838703|NCT02662582|147226772|SUPERIORITY||LSMean difference|0.85||||0.775|TWO_SIDED|90.0|-4.12|5.82||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||5.82|-4.12|0.775
73838704|NCT02662582|147226773|SUPERIORITY||LSMean difference|1.1||||0.544|TWO_SIDED|90.0|-1.9|4.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.0|-1.9|0.544
73898453|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|3.03|||TWO_SIDED|||||||||Week 72||||
73838705|NCT02662582|147226773|SUPERIORITY||LSMean difference|2.1||||0.216|TWO_SIDED|90.0|-0.7|5.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||5.0|-0.7|0.216
73838706|NCT02662582|147226774|SUPERIORITY||LSMean difference|-7.4||||0.171|TWO_SIDED|90.0|-16.5|1.6||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.6|-16.5|0.171
73838707|NCT02662582|147226774|SUPERIORITY||LSMean difference|0.2||||0.976|TWO_SIDED|90.0|-10.3|10.7||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||10.7|-10.3|0.976
73838708|NCT02662582|147226775|SUPERIORITY||LSMean difference|-0.6||||0.844|TWO_SIDED|90.0|-6.1|4.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.9|-6.1|0.844
73838709|NCT02662582|147226775|SUPERIORITY||LSMean difference|-0.9||||0.751|TWO_SIDED|90.0|-5.8|4.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.0|-5.8|0.751
73838710|NCT02662582|147226776|SUPERIORITY||LSMean difference|0.2||||0.59|TWO_SIDED|90.0|-0.5|0.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.9|-0.5|0.590
73838711|NCT02662582|147226776|SUPERIORITY||LSMean difference|0.3||||0.399|TWO_SIDED|90.0|-0.3|0.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.9|-0.3|0.399
73838712|NCT02662582|147226777|SUPERIORITY||LSMean difference|-0.09||||0.151|TWO_SIDED|90.0|-0.2|0.01||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.01|-0.20|0.151
73838713|NCT02662582|147226778|SUPERIORITY||LSMean difference|-0.007||||0.857|TWO_SIDED|90.0|-0.07|0.056||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.056|-0.070|0.857
73838714|NCT02662582|147226779|SUPERIORITY||LSMean difference|1.56||||0.11|TWO_SIDED|90.0|-0.05|3.17||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||3.17|-0.05|0.110
73838715|NCT02662582|147226780|SUPERIORITY||LSMean difference|2.07||||0.766|TWO_SIDED|90.0|-9.57|13.71||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||13.71|-9.57|0.766
73838716|NCT02662582|147226780|SUPERIORITY||LSMean difference|2.94||||0.642|TWO_SIDED|90.0|-7.66|13.54||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||13.54|-7.66|0.642
73838717|NCT01953354|147226814|SUPERIORITY_OR_OTHER|||||||1||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||1.000
73838718|NCT01953354|147226815|SUPERIORITY_OR_OTHER|||||||1||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||1.000
73838719|NCT01953354|147226816|SUPERIORITY_OR_OTHER|||||||0.242||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.242
73838720|NCT01953354|147226817|SUPERIORITY_OR_OTHER|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.550
73838721|NCT01953354|147226820|SUPERIORITY_OR_OTHER|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.550
73838722|NCT01953354|147226821|SUPERIORITY_OR_OTHER|||||||0.633||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.633
73838723|NCT00806026|147226835|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-4.5|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-5.9|-3.2||This analysis was step 1 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region \[United states (US) or European union (EU)\], treatment, week and treatment by week interaction as fixed effects.||-3.20|-5.90|<0.0001
73970967|NCT05139810|147481975|SUPERIORITY||Odds Ratio (OR)|3.23|||=|0.24|TWO_SIDED|95.0|0.46|22.85|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.||||22.85|0.46|=0.240
73838724|NCT00806026|147226835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3603|TWO_SIDED|95.0|-2.0|0.7||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.7|-2.0|0.3603
73838725|NCT00806026|147226835|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.5|-1.9||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-1.9|-4.5|<0.0001
73838726|NCT00806026|147226836|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||This analysis was step 2 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pregabalin 300 mg versus placebo: Cochran-Mantel-Haenszel (CMH) test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||<0.0001
73838727|NCT00806026|147226836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4393|TWO_SIDED|||||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.25 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||0.4393
73838728|NCT00806026|147226836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|||||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.5 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||0.0022
73838729|NCT00806026|147226837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0826|TWO_SIDED|||||This analysis was step 6 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.25 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.||||0.0826
73838730|NCT00806026|147226837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|TWO_SIDED|||||This analysis was step 3 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.5 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.||||0.0012
73838731|NCT00806026|147226839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.25|STANDARD_ERROR_OF_MEAN|4.332|<|0.0001|TWO_SIDED|95.0|-25.76|-8.74||This analysis was step 7 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-8.74|-25.76|<0.0001
73838732|NCT00806026|147226839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|STANDARD_ERROR_OF_MEAN|4.408||0.8075|TWO_SIDED|95.0|-9.73|7.58||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||7.58|-9.73|0.8075
73838733|NCT00806026|147226839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.57|STANDARD_ERROR_OF_MEAN|4.318||0.2906|TWO_SIDED|95.0|-13.05|3.91||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||3.91|-13.05|0.2906
73838734|NCT00806026|147226845|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.93||0.7073|TWO_SIDED|95.0|-9.3|6.3||This analysis was step 8 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||6.30|-9.30|0.7073
73838735|NCT00806026|147226845|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|3.78||0.5299|TWO_SIDED|95.0|-5.1|9.9||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||9.9|-5.1|0.5299
73838736|NCT00806026|147226845|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|3.69||0.0354|TWO_SIDED|95.0|-15.2|-0.5||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-0.5|-15.2|0.0354
74083806|NCT00377572|147720744|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Percent Adherence Comparison||||0.12
74083807|NCT00377572|147720745|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 1- 2 (mild asthma) Percent Comparison||||0.001
74083808|NCT00377572|147720746|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 4 - 6 (severe asthma)percent comparison||||<0.001
74083809|NCT00377572|147720747|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Inhaled glucocorticoids prescribed - mcg per day comparison||||<0.001
74083810|NCT00377572|147720748|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Comparison percent prescribed long-acting beta 2 agonists||||0.003
74083811|NCT00377572|147720749|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Regression, Logistic|Hospitalizations were summed over the course of the double-blind \& analyzed with logistic regression (LR) of 'any' vs. 'none'. The LR was unadjusted.||||||0.02
74083812|NCT00377572|147720750|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|Exacerbations were summed over the course of the double-blind and analyzed with an LR of 'any' versus 'none'. LR adjusted for study site and dosing.||||||<0.001
74083813|NCT00377572|147720751|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
74083814|NCT00377572|147720752|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.58
74083815|NCT01705717|147720757|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Chi-squared|||||||0.034
74083816|NCT01705717|147720758|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Chi-squared|||||||0.007
74083817|NCT00769314|147720760|SUPERIORITY_OR_OTHER||Treatment difference|0.0685||||0.0419|TWO_SIDED|95.0|0.0025|0.1339||p-value \< 0.05 considered significant|Chi-squared||Treatment difference was the proportion of patients with aborted lesions in the acyclovir Lauriad group minus the proportion of patients with aborted lesions in the placebo group.|||0.1339|0.0025|0.0419
74083818|NCT00769314|147720761|SUPERIORITY_OR_OTHER|||||||0.0683||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0683
74083819|NCT00769314|147720762|SUPERIORITY_OR_OTHER|||||||0.0033||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0033
74083820|NCT00769314|147720763|SUPERIORITY_OR_OTHER|||||||0.0098||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0098
74083821|NCT00769314|147720764|SUPERIORITY_OR_OTHER|||||||0.8005||||||p-value \< 0.05 considered significant|Log Rank|||||||0.8005
74083822|NCT00769314|147720765|SUPERIORITY_OR_OTHER|||||||0.015||||||p-value \< 0.05 considered significant|Log Rank|||||||0.015
74083823|NCT00769314|147720766|SUPERIORITY_OR_OTHER|||||||0.0412||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0412
74083824|NCT00769314|147720767|SUPERIORITY_OR_OTHER|||||||0.0271||||||p-value \< 0.05 considered significant|Chi-squared|||||||0.0271
74083825|NCT00769314|147720768|SUPERIORITY_OR_OTHER|||||||0.5695||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 1 timepoint.||||0.5695
74083826|NCT00769314|147720768|SUPERIORITY_OR_OTHER|||||||0.1824||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 3 timepoint||||0.1824
74083827|NCT00769314|147720768|SUPERIORITY_OR_OTHER|||||||0.0078||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 5 timepoint||||0.0078
74083828|NCT00769314|147720768|SUPERIORITY_OR_OTHER|||||||0.3303||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 7 timepoint||||0.3303
74083829|NCT00769314|147720768|SUPERIORITY_OR_OTHER|||||||0.6045||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 14 timepoint||||0.6045
74083830|NCT00769314|147720769|SUPERIORITY_OR_OTHER|||||||0.0022||||||p-value \< 0.05 considered significant|Chi-squared|||||||0.0022
74083831|NCT04980456|147720804|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, and sequence) and random (subject) effects. Difference = TOTAL30 minus Biofinity|||0.01||
74083832|NCT04832971|147720805|SUPERIORITY||Difference vs. Placebo at Week 24|-51.22|||<|0.0001|TWO_SIDED|95.0|-61.73|-40.7||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures (MMRM)||ARO-ANG3 - Placebo|||-40.70|-61.73|<.0001
74083833|NCT04832971|147720805|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
74083834|NCT04832971|147720805|SUPERIORITY||Difference vs Placebo at Week 24|-56.56|||<|0.0001|TWO_SIDED|95.0|-67.09|-46.04||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures (MMRM)||ARO-ANG3 - Placebo|||-46.04|-67.09|<.0001
74083835|NCT04832971|147720805|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
74083836|NCT04832971|147720805|SUPERIORITY||Difference vs. Placebo at Week 24|-63.11|||<|0.0001|TWO_SIDED|95.0|-73.56|-52.66||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model with Repeated Measures|||||-52.66|-73.56|<.0001
73838737|NCT00806026|147226847|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.28||0.0004|TWO_SIDED|95.0|-1.55|-0.45||This analysis was step 9 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-0.45|-1.55|0.0004
73838738|NCT00806026|147226847|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.282||0.1242|TWO_SIDED|95.0|-0.99|0.12||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.12|-0.99|0.1242
73838739|NCT00806026|147226847|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.287||0.0553|TWO_SIDED|95.0|-1.12|0.01||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.01|-1.12|0.0553
73838740|NCT00452530|147226864|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5||||0.0003||||||1-sided P-value|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.||||0.0003
73838741|NCT00452530|147226864|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.04||||||95.0|-2.03|-0.05|||Inverse variance method|||Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.||-0.05|-2.03|
73838742|NCT00452530|147226865|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-0.33||||0.3014|TWO_SIDED|95.0|-0.95|0.29|||Mantel Haenszel||Apixaban-enoxaparin|Major bleeding||0.29|-0.95|0.3014
73838743|NCT00452530|147226865|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-0.91||||0.1668|TWO_SIDED|95.0|-2.2|0.38|||Mantel Haenszel||Apixaban-enoxaparin|CRNM||0.38|-2.20|0.1668
73959636|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.8168|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.8168
73838744|NCT00452530|147226865|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-1.24||||0.0881|TWO_SIDED|95.0|-2.66|0.18|||Mantel Haenszel||Apixaban-enoxaparin|Major or CRNM||0.18|-2.66|0.0881
73838745|NCT00452530|147226865|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-1.39||||0.1412|TWO_SIDED|95.0|-3.29|0.51|||Mantel Haenszel||Apixaban-enoxaparin|Any bleeding||0.51|-3.29|0.1412
73838746|NCT00452530|147226866|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.74||P-value was statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.||0.74|0.51|<0.0001
73838747|NCT00452530|147226866|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.27|||<|0.0001||95.0|-12.74|-5.79||P-value is statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.||-5.79|-12.74|<0.0001
73838748|NCT00728182|147226878|SUPERIORITY_OR_OTHER|||||||0.445||95.0|||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regression.||Comparison of the summed volume of new FLAIR lesions in the NA-1 and placebo treated groups.||||0.445
73838749|NCT00728182|147226879|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.53||||0.018|TWO_SIDED|95.0|0.38|0.74|||Generalized linear model|With log link and negative bnomial distribution.||Comparison of the total number of new ischemic lesions on DWI for NA-1 versus placebo treated groups.||0.74|0.38|0.018
73838750|NCT00728182|147226880|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.59||||0.048|TWO_SIDED|95.0|0.42|0.83|||Generalized linear model|With log link and negative binomial distribution.||Comparison of the total number of new FLAIR lesions in the NA-1 versus placebo treated groups.||0.83|0.42|0.048
73838751|NCT00728182|147226881|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regresion.||Comparison of the summed volume of new ischemic lesions on DWI.||||0.306
73838752|NCT00728182|147226882|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||0.43|TWO_SIDED|95.0|0.9|1.1|||Chi-squared|||Number of patients obtaining a score on the NIHSS of 0-1 at Day 30.||1.1|0.9|0.43
73838753|NCT00728182|147226883|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||1|TWO_SIDED|95.0|0.9|1.1|||Chi-squared|||Comparison of the number of patients with mRS scores of 0-2 at Day 30 for NA-1 and placebo treated groups.||1.1|0.9|1.00
73838754|NCT00728182|147226884|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|||||||0.023
73838755|NCT00728182|147226885|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.36||||0.027|TWO_SIDED|95.0|0.17|0.73|||Adjusted Incidence Rate Ratio|||||0.73|0.17|0.027
73838756|NCT00728182|147226886|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.36||||0.046|TWO_SIDED|95.0|0.17|0.75|||Generalized linear model|||||0.75|0.17|0.046
73838757|NCT00728182|147226887|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.015
73838758|NCT00728182|147226888|SUPERIORITY_OR_OTHER||Relative Risk|1.5||||0.02|TWO_SIDED|95.0|1.1|2.0|||Chi-squared|||||2.0|1.1|0.02
73838759|NCT00728182|147226889|SUPERIORITY_OR_OTHER||Relative Risk|1.3||||0.18|TWO_SIDED|95.0|0.95|1.7|||Chi-squared|||||1.7|0.95|0.18
73838760|NCT01898091|147226891|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxin rank sum test|||Simulations determined power to detect significant difference defined as a mean difference of 1 unit (MTS scale). Feasibility study provided proportion of patients in control and neem group with change scores of 0, 1, 2, 3, and 4 as (5%, 10%, 10%, 45% and 30%) and (15%, 20%, 30%, 25% and 10%), respectively. Simulated 10,000 trials using multinomial distributions by the percentages above, with 20 patients per group, provided 80% power to detect 0.9 unit difference using a one-sided alpha of 0.05.||||0.84
73838761|NCT01618708|147226892|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|0.07|||=|0.7462|TWO_SIDED|95.0|-0.38|0.52||Threshold for significance at 0.05 level|Mixed Models Analysis||Placebo vs Synvisc-One|Synvisc-One group was compared to placebo group using mixed model for repeated measures (MMRM) approach assuming missing data at random (MAR).||0.52|-0.38|= 0.7462
73838762|NCT01725308|147226904|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.4||||0.034|TWO_SIDED|95.0|-4.7|-0.2|||ANCOVA|||An analysis of covariance (ANCOVA) using a model where the total MADRS score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/ II) are fixed effects.||-0.2|-4.7|0.034
73838763|NCT01725308|147226911|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.7||||0.033|TWO_SIDED|95.0|-3.3|-0.1|||ANCOVA|||At End of Treatment Period I/Week 8: An analysis of covariance (ANCOVA) using a model where the total HAM-D17 score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/II) are fixed effects.||-0.1|-3.3|0.033
73838764|NCT03511209|147226955|SUPERIORITY||Odds Ratio (OR)|2.13|STANDARD_ERROR_OF_MEAN|0.85||0.056|TWO_SIDED|95.0|0.98|4.64|||Regression, Logistic|||Compared CBTI plus Taper method A to CBTI plus Taper method B||4.64|0.98|0.056
73838765|NCT03511209|147226956|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|1.27||0.405|TWO_SIDED|95.0|-3.57|1.44|||Mixed Models Analysis|Interaction contrast of Treatment Group (CBTI plus Taper method A vs. CBTI plus Taper method B) by Time (6 Months vs. Baseline)||||1.44|-3.57|0.405
73838766|NCT04679818|147226988|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.895|TWO_SIDED|99.0|-1.43|1.58|||Mixed Models Analysis|||||1.58|-1.43|0.895
73838767|NCT04679818|147226989|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.228|TWO_SIDED|99.0|-2.66|0.99|||Mixed Models Analysis|||||0.99|-2.66|0.228
73838768|NCT04679818|147226990|SUPERIORITY||Risk Ratio (RR)|0.81||||0.565|TWO_SIDED|95.0|0.4|1.65|||generalized linear mixed effects model|||||1.65|0.40|0.565
73838769|NCT04679818|147226991|SUPERIORITY||Risk Ratio (RR)|1.48||||0.379|TWO_SIDED|95.0|0.62|3.54|||Generalized linear mixed effects model|||||3.54|0.62|0.379
73838770|NCT04679818|147226992|SUPERIORITY||Median Difference (Final Values)|0.54||||0.039|TWO_SIDED|95.0|0.3|0.97|||Wilcoxon (Mann-Whitney)|||||0.97|0.30|0.039
73838771|NCT04679818|147226993|NON_INFERIORITY|We tested noninferiority of NOL to routine care on the Ramsey score using an a priori-defined noninferiority delta of 1.2 for the proportional odds ratio; NOL would be deemed noninferior if the upper confidence limit for the odds ratio was \<1.2.|Odds Ratio (OR)|0.8||||0.169|TWO_SIDED|95.0|0.35|1.82|||proportional odds model|||||1.82|0.35|0.169
73838772|NCT04679818|147226994|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.967|TWO_SIDED|95.0|0.63|1.63|||Cox proportional hazards regression|||||1.63|0.63|0.967
73838773|NCT03378635|147226995|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test. Kaplan-Meier estimate with 95% CI, p-value based on treatment group difference between dasiglucagon and placebo using a two-sided log-rank test stratified by injection site. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.||||<0.001
74083837|NCT04832971|147720805|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
74083838|NCT04832971|147720807|SUPERIORITY||Difference vs. Placebo at Week 24|-29.2|||<|0.0001|TWO_SIDED|95.0|-38.5|-20.0||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-20.0|-38.5|<.0001
74083839|NCT04832971|147720807|SUPERIORITY||Difference vs. Placebo at Week 24|-28.7|||<|0.0001|TWO_SIDED|95.0|-37.9|-19.5||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-19.5|-37.9|<.0001
74083840|NCT04832971|147720807|SUPERIORITY||Difference vs. Placebo at Week 24|-36.4|||<|0.0001|TWO_SIDED|95.0|-45.5|-27.2||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-27.2|-45.5|<.0001
74083841|NCT04832971|147720809|SUPERIORITY||Difference vs. Placebo at Week 24|-18.66|||<|0.0001|TWO_SIDED|95.0|-26.53|-10.8||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-10.80|-26.53|<.0001
74083842|NCT04832971|147720809|SUPERIORITY||Difference vs. Placebo at Week 24|-15.18||||0.0002|TWO_SIDED|95.0|-23.0|-7.36||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-7.36|-23.00|0.0002
74083843|NCT04832971|147720809|SUPERIORITY||Difference vs. Placebo at Week 24|-21.9|||<|0.0001|TWO_SIDED|95.0|-29.69|-14.12||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-14.12|-29.69|<.0001
74083844|NCT04832971|147720811|SUPERIORITY||Difference vs. Placebo at Week 24|-16.0||||0.0138|TWO_SIDED|95.0|-28.7|-3.3||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-3.3|-28.7|0.0138
74083845|NCT04832971|147720811|SUPERIORITY||Difference vs Placebo at Week 24|-9.3||||0.148|TWO_SIDED|95.0|-22.0|3.3||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repated Measures|||||3.3|-22.0|0.1480
74083846|NCT04832971|147720811|SUPERIORITY||Difference vs Placebo at Week 24|-20.2||||0.0019|TWO_SIDED|95.0|-32.8|-7.5||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mxed Models Repeated Measures|||||-7.5|-32.8|0.0019
74083847|NCT04832971|147720813|SUPERIORITY||Difference vs Placebo|-54.26|||<|0.0001|TWO_SIDED|95.0|-62.11|-46.4||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|mixed Models Repeated Measures|||||-46.40|-62.11|<.0001
74083848|NCT04832971|147720813|SUPERIORITY||Difference vs Placebo at Week 24|-69.76|||<|0.0001|TWO_SIDED|95.0|-77.58|-61.95||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-61.95|-77.58|<.0001
74083849|NCT04832971|147720813|SUPERIORITY||Difference vs Placebo at Week 24|-73.69|||<|0.0001|TWO_SIDED|95.0|-81.44|-65.93||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-65.93|-81.44|<.0001
74083850|NCT04832971|147720815|SUPERIORITY||Difference vs Placebo at Week 24|-12.0||||0.0039|TWO_SIDED|95.0|-20.2|-3.9||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-3.9|-20.2|0.0039
73838774|NCT03378635|147226996|SUPERIORITY||||||<|0.001||||||p-value was \<0.001 at all time points (10, 15, 20 and 30 minutes)|Fisher Exact|||Pairwise test of independent binomial proportions with Fisher's Exact test comparing dasiglucagon versus placebo. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.001
73838775|NCT03378635|147226997|SUPERIORITY||||||<|0.001||||||The p-value was \<0.001 at all time points (10, 15, 20 and 30 minutes)|ANCOVA|||Plasma glucose (PG) change from baseline at rescue was carried forward in patients who required rescue intravenous (IV) glucose before reaching PG recovery. Change from baseline was analyzed using an ANCOVA, with treatment group as fixed effect and baseline PG as covariate. Group difference was evaluated inferentially following an a priori defined hierarchical test order, proceeding until the first failure to reject the null hypothesis.||||<0.001
73838776|NCT03378635|147226998|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated using a Kaplan-Meier estimate with 95% confidence interval, p-value based on a pairwise two-sided log-rank test versus placebo.||||<0.001
73838777|NCT03378635|147226999|SUPERIORITY||Mean Difference (Net)|0.131|||<|0.001|TWO_SIDED|95.0|0.1|0.171|||ANCOVA|||The log-transformed AUC endpoint was analyzed using an analysis of covariance model with treatment as fixed effect and baseline plasma glucose modeled as a covariate. The least squares means treatment group differences were back-transformed (anti-logged) for presentation as a ratio of the treatment group geometric means, with their corresponding 95% confidence interval.||0.171|0.1|<0.001
73838778|NCT03378635|147227000|SUPERIORITY||Mean Difference (Net)|0.91||||0.144|TWO_SIDED|95.0|0.801|1.033|||ANCOVA|||Least square mean ratio for GlucaGen: dasiglucagon||1.033|0.801|0.144
73838779|NCT03378635|147227001|SUPERIORITY||Mean Difference (Net)|0.844||||0.006|TWO_SIDED|95.0|0.749|0.951|||ANCOVA|||Least square mean ratio for GlucaGen: dasiglucagon||0.951|0.749|0.006
73838780|NCT01316900|147227015|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.142|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.142|0.039|<0.001
73838781|NCT01316900|147227015|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.141||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Tio 18 µg.|||0.141|0.039|<0.001
73838782|NCT01316900|147227015|SUPERIORITY_OR_OTHER||Least squares mean difference|0.088|||<|0.001|TWO_SIDED|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.140|0.036|<0.001
73838783|NCT01316900|147227015|SUPERIORITY_OR_OTHER||Least squares mean difference|0.088|||<|0.001|TWO_SIDED|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.|||0.140|0.036|<0.001
73838784|NCT02496156|147227020|SUPERIORITY||||||<|0.39||||||This is a computed p-value.|Mixed Models Analysis|||Missing data treatment was done using multiple imputation methods when data were determined to be Missing Completely at Random or Missing at Random. Assumptions underlying each statistical test were evaluated before proceeding with specific analyses.|For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||<0.39
73838785|NCT02496156|147227021|SUPERIORITY||||||>|0.05||||||Computed p-value exceeded the .05 level of significance.|Mixed Models Analysis||||For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
73838786|NCT02496156|147227022|SUPERIORITY||||||>|0.05||||||This is a computed p-value.|Mixed Models Analysis|||See description of analysis below.|For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
73838787|NCT02496156|147227023|SUPERIORITY||||||>|0.05||||||Computed p-value|ANCOVA|Difference in post-test scores with baseline Knowledge test score as the covariate.||||||>0.05
73863165|NCT01073930|147272412|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|10.7|||||ONE_SIDED|97.5|4.9|||||||Ascending colon comparison|||4.9|
73838788|NCT02496156|147227025|SUPERIORITY|See analysis description below.|||||>|0.05||||||Computed p-value|ANOVA||||For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
73838789|NCT00507507|147227066|SUPERIORITY_OR_OTHER|||||||0.016||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||The null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference. The sample size provided at least 85% power to detect a difference of 30% between the groups, assuming response rates of 30% and 60% in the Tenofovir DF and FTC+Tenofovir DF groups, respectively.||||0.016
73838790|NCT00507507|147227067|SUPERIORITY_OR_OTHER|||||||0.05||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.050
73838791|NCT00507507|147227067|SUPERIORITY_OR_OTHER|||||||0.009||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.009
73838792|NCT00507507|147227067|SUPERIORITY_OR_OTHER|||||||0.03||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.030
73838793|NCT00507507|147227068|SUPERIORITY_OR_OTHER|||||||0.703||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.703
73838794|NCT00507507|147227068|SUPERIORITY_OR_OTHER|||||||0.034||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.034
73838795|NCT00507507|147227068|SUPERIORITY_OR_OTHER|||||||0.011||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.011
73838796|NCT00507507|147227068|SUPERIORITY_OR_OTHER|||||||0.007||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.007
73838797|NCT00507507|147227069|SUPERIORITY_OR_OTHER|||||||0.01||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.010
73838798|NCT00507507|147227070|SUPERIORITY_OR_OTHER|||||||0.019||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.019
73838799|NCT00507507|147227071|SUPERIORITY_OR_OTHER|||||||0.186||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.186
73838800|NCT00507507|147227072|SUPERIORITY_OR_OTHER|||||||0.07||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.070
73838801|NCT00507507|147227073|SUPERIORITY_OR_OTHER|||||||0.467||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.467
73838802|NCT00507507|147227073|SUPERIORITY_OR_OTHER|||||||1||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||1.000
73838803|NCT00507507|147227073|SUPERIORITY_OR_OTHER|||||||0.529||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.529
73959637|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.3248|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.3248
73959638|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.3148|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.3148
73959639|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6563|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.6563
73959640|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.12||0.1735|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.1735
73959641|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.1237|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1237
73959642|NCT00430300|147454769|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.11||0.6113|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.6113
73959643|NCT00430300|147454770|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.5549|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.5549
73959644|NCT00430300|147454770|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.988|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.9880
73959645|NCT00430300|147454770|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.8572|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.8572
73959646|NCT00430300|147454770|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.8402|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.8402
74022080|NCT03093402|147596789|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 29.||||||0.872|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.872
74022081|NCT03093402|147596789|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 57.||||||0.895|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.895
74022082|NCT03093402|147596789|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 85.||||||0.669|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.669
73838804|NCT00507507|147227073|SUPERIORITY_OR_OTHER|||||||0.451||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.451
74022083|NCT03093402|147596789|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 113.||||||0.668|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.668
74083851|NCT04832971|147720815|SUPERIORITY||Difference vs Placebo at Week 24|-21.6|||<|0.0001|TWO_SIDED|95.0|-29.8|-13.4||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-13.4|-29.8|<.0001
74083852|NCT04832971|147720815|SUPERIORITY||Differeence vs Placebo at week 24|-24.5|||<|0.0001|TWO_SIDED|95.0|-32.6|-16.5||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-16.5|-32.6|<.0001
73838805|NCT00507507|147227074|SUPERIORITY_OR_OTHER|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.496
73838806|NCT00507507|147227074|SUPERIORITY_OR_OTHER|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.119
73838807|NCT00507507|147227074|SUPERIORITY_OR_OTHER|||||||0.365||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.365
73838808|NCT00507507|147227075|SUPERIORITY_OR_OTHER|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.496
73838809|NCT00507507|147227075|SUPERIORITY_OR_OTHER|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.119
73838810|NCT00507507|147227075|SUPERIORITY_OR_OTHER|||||||0.244||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.244
73838811|NCT01623154|147227091|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||TWO_SIDED|95.0|0.987|0.993||95% confidence interval is used instead of p-value.|Deming Regression|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.993|0.987|
73838812|NCT01623154|147227091|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.04|||||TWO_SIDED|95.0|-0.25|0.17|||Deming Regression|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.17|-0.25|
73838813|NCT01623154|147227091|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||TWO_SIDED|95.0|0.987|0.993|||Regression, Linear|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.993|0.987|
73838814|NCT01623154|147227091|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.03|||||TWO_SIDED|95.0|-0.24|0.18|||Regression, Linear|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.18|-0.24|
73838815|NCT01623154|147227091|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.995|||||TWO_SIDED|95.0|0.99|1.0|||Passing-Bablock|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||1.000|0.990|
73838816|NCT01623154|147227091|NON_INFERIORITY_OR_EQUIVALENCE|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|Intercept|-0.04|||||TWO_SIDED|95.0|-0.3|0.01|||Passing-Bablok|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.||0.01|-0.30|
73838817|NCT01623154|147227091|NON_INFERIORITY_OR_EQUIVALENCE|Described previously|Relative Sensitivity, %|100.0|||||TWO_SIDED|95.0|85.8|100.0|||||95% confidence interval is used instead of p-value.|Comparison of UHR Values obtained by UBit-IR300 and POCone were used to identify participants' H.pylori infection status. Participants with UHR value ≥ 10.0μg/min were considered positive for H.Pylori.||100|85.8|
73838818|NCT01623154|147227091|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously|Relative Specificity, %|100.0|||||TWO_SIDED|95.0|94.9|100.0|||||95% confidence interval is used instead of p-value.|||100|94.9|
73838819|NCT02656173|147227100|SUPERIORITY||least square mean difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.82|-0.21|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis, including treatment group and region as fixed factors and baseline as a covariate.||-0.21|-0.82|<0.001
73838820|NCT02656173|147227101|SUPERIORITY||least square mean difference|-0.48|||<|0.001|TWO_SIDED|95.0|-0.78|-0.17|||mixed model repeated measure|||Mixed Model Repeated Measure (MMRM) was used for analysis, which included the baseline as a covariate, treatment group, analysis visits and region as a fixed effect, subject as random effect and including interaction of \[treatment group x visit\] for FAS.||-0.17|-0.78|<0.001
73838821|NCT02656173|147227102|SUPERIORITY||least square mean difference|-0.28||||0.112|TWO_SIDED|95.0|-0.63|0.07|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.07|-0.63|0.112
73838822|NCT02656173|147227103|SUPERIORITY||Cochran-Mantel-Haenszel Statistics|1.75||||0.186|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.||||0.186
73838823|NCT02656173|147227104|SUPERIORITY||Cochran-Mantel-Haenszel Statistics|0.09||||0.76|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.||||0.760
73838824|NCT02656173|147227105|SUPERIORITY||Least square mean difference|-0.03||||0.646|TWO_SIDED|95.0|-0.18|0.11|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.11|-0.18|0.646
73838825|NCT02656173|147227106|SUPERIORITY||Least square mean difference|12.08|||<|0.001|TWO_SIDED|95.0|6.33|17.84|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||17.84|6.33|<0.001
73838826|NCT02656173|147227107|SUPERIORITY||Least square mean difference|-0.65||||0.001|TWO_SIDED|95.0|-1.04|-0.26|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.26|-1.04|0.001
73838827|NCT02656173|147227108|SUPERIORITY||Least square mean difference|-0.11||||0.006|TWO_SIDED|95.0|-0.19|-0.03|||ANCOVA|||Subscale: Daytime Frequency. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.03|-0.19|0.006
73838828|NCT02656173|147227108|SUPERIORITY||Least square mean difference|-0.08||||0.174|TWO_SIDED|95.0|-0.19|0.03|||ANCOVA|||Subscale: Nighttime Frequency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.03|-0.19|0.174
73838829|NCT02656173|147227108|SUPERIORITY||Least square mean difference|-0.26||||0.037|TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||Subscale: Urgency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.02|-0.50|0.037
73838830|NCT02656173|147227108|SUPERIORITY||Least square mean difference|-0.18||||0.014|TWO_SIDED|95.0|-0.32|-0.04|||ANCOVA|||Subscale: Urgency Incontinence. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.04|-0.32|0.014
73838831|NCT02656173|147227109|SUPERIORITY||Least square mean difference|-1.19||||0.002|TWO_SIDED|95.0|-1.94|-0.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.44|-1.94|0.002
73838832|NCT02656173|147227110|SUPERIORITY||Least square mean difference|-0.78|||<|0.001|TWO_SIDED|95.0|-1.13|-0.43|||ANCOVA|||Subscale: Storage Subscale. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.43|-1.13|<0.001
73838833|NCT02656173|147227110|SUPERIORITY||Least square mean difference|-0.3||||0.167|TWO_SIDED|95.0|-0.72|0.13|||ANCOVA|||Subscale: Voiding Subscale-1. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.13|-0.72|0.167
73838834|NCT02656173|147227110|SUPERIORITY||Least square mean difference|-0.42||||0.103|TWO_SIDED|95.0|-0.93|0.09|||ANCOVA|||Subscale: Voiding Subscale-2. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.09|-0.93|0.103
73838835|NCT02656173|147227110|SUPERIORITY||Least square mean difference|-0.29||||0.009|TWO_SIDED|95.0|-0.51|-0.07|||ANCOVA|||Subscale: Quality of Life (QoL) Item. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.07|-0.51|0.009
73838836|NCT02656173|147227111|SUPERIORITY||Least square mean difference|-4.52|||<|0.001|TWO_SIDED|95.0|-6.91|-2.13|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-2.13|-6.91|<0.001
73838837|NCT02656173|147227112|SUPERIORITY||Least square mean difference|2.79|||<|0.001|TWO_SIDED|95.0|1.13|4.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||4.44|1.13|<0.001
73838838|NCT01064622|147227116|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.15|TWO_SIDED|95.0|0.55|1.22||Reported p-value is one-sided. p\<0.10 required for statistical significance.|Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|||1.22|0.55|0.15
73838839|NCT01064622|147227117|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.37|TWO_SIDED|95.0|0.64|1.46|||Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|||1.46|0.64|0.37
73838840|NCT01064622|147227118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|TWO_SIDED|||||Two-sided p-value for Cochran-Mantel-Haenszel test stratified by Karnofsky performance status and disease status.|Cochran-Mantel-Haenszel|||||||0.42
73838841|NCT03449147|147227121|SUPERIORITY||Estimated Relative Reduction (%)|-1.14||||0.875|TWO_SIDED|95.0|-14.27|14.02||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||14.02|-14.27|0.875
73838842|NCT03449147|147227121|SUPERIORITY||Estimated Relative Reduction (%)|-14.64||||0.031|TWO_SIDED|95.0|-26.07|-1.43||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||-1.43|-26.07|0.031
73838843|NCT03449147|147227124|SUPERIORITY||Estimated Relative Reduction (%)|-3.03||||0.677|TWO_SIDED|95.0|-16.14|12.12||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||12.12|-16.14|0.677
73838844|NCT03449147|147227124|SUPERIORITY||Estimated Relative Reduction (%)|-15.79||||0.022|TWO_SIDED|95.0|-27.27|-2.5||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||-2.50|-27.27|0.022
73838845|NCT03449147|147227125|SUPERIORITY||Odds Ratio (OR)|1.34||||0.077|TWO_SIDED|95.0|0.97|1.85||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||1.85|0.97|0.077
73838846|NCT03449147|147227125|SUPERIORITY||Odds Ratio (OR)|1.41||||0.04|TWO_SIDED|95.0|1.02|1.96||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||1.96|1.02|0.040
73838847|NCT03449147|147227126|SUPERIORITY||Odds Ratio (OR)|1.03||||0.872|TWO_SIDED|95.0|0.75|1.4||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.|Regression, Logistic|||||1.40|0.75|0.872
73838848|NCT03449147|147227126|SUPERIORITY||Odds Ratio (OR)|1.33||||0.082|TWO_SIDED|95.0|0.96|1.83||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.|Regression, Logistic|||||1.83|0.96|0.082
73838849|NCT03449147|147227127|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.96|1.83||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||1.83|0.96|
73838850|NCT03449147|147227127|OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.08|2.09||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.09|1.08|
73838851|NCT03449147|147227128|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.93|1.69||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||1.69|0.93|
73838852|NCT03449147|147227128|OTHER||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.31|2.39||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.39|1.31|
73838853|NCT03449147|147227129|OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|1.14|2.05||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.||2.05|1.14|
73838854|NCT03449147|147227129|OTHER||Odds Ratio (OR)|1.65||||||95.0|1.23|2.22||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.||2.22|1.23|
73838855|NCT03160573|147227156|SUPERIORITY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||Test Flavored Rinse, Placebo Flavored Rinse||||<0.00001
73838856|NCT03160573|147227156|SUPERIORITY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||Test Unflavored Rinse, Placebo Unflavored Rinse||||<0.00001
73898454|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.361||0.12|TWO_SIDED|95.0|-1.274|0.147||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.147|-1.274|0.120
73838857|NCT02462057|147227218|EQUIVALENCE|The anticipated sample size of 3500 provided 80% power to detect a 3% pairwise difference between the proportions of participants who enrolled in HF with significance testing conducted at the Bonferroni-corrected significance level of 0.005 (0.05/10) to account for the 10 pairwise between-arm comparisons and pessimistically allowing for up to 10% further exclusions. The baseline monthly enrolment rate was estimated at ∼1%/month.|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74022084|NCT03093402|147596790|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.82|TWO_SIDED|95.0|-2.3|1.5||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for High JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.5|-2.3|.820
74022085|NCT03093402|147596790|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.82|TWO_SIDED|95.0|-2.0|1.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for Medium JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.8|-2.0|.820
74022086|NCT03093402|147596790|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.82|TWO_SIDED|95.0|-2.6|1.1||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for Low JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.1|-2.6|.820
74022087|NCT03093402|147596791|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.244|TWO_SIDED|95.0|-3.0|4.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||4.4|-3.0|.244
74022088|NCT03093402|147596791|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.244|TWO_SIDED|95.0|-5.2|2.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for Medium JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||2.0|-5.2|.244
74022089|NCT03093402|147596791|SUPERIORITY||Median Difference (Final Values)|-2.6||||0.244|TWO_SIDED|95.0|-6.2|0.9||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||0.9|-6.2|.244
74083853|NCT02293460|147720821|SUPERIORITY|The response rate was tested against the historical response rate of 33.3%.|Responder rate|76.2|||<|0.0001|TWO_SIDED|95.0|60.5|87.9||One-sided test at nominal level of significance alpha = 2.5 %|exact binomial Clopper-Pearson|||"For this single-arm study, the response rate was tested against the historical response rate of 33.3% with a 1-sided Clopper-Pearson exact test at the nominal level of significance of 2.5% on the Full Analysis Set. The null and alternative hypotheses were as follows:~H0: pI10E \<= 33.3% H1: pI10E \> 33.3%"||87.9|60.5|<0.0001
73838858|NCT02336555|147227229|SUPERIORITY||Mean Difference (Final Values)|-0.452||||0.075|TWO_SIDED|95.0|-1.076|0.172||Linear mixed model with a posterior probability evaluation for the treatment effect|Linear mixed model|One-sided p-value and a posterior probability greater than 90% that the treatment effect is less than 0.||||0.172|-1.076|0.075
73838859|NCT02336555|147227230|SUPERIORITY||Odds Ratio (OR)|1.073|||||TWO_SIDED|95.0|0.446|2.58|||||Logistic regression model with factors for treatment \& baseline pain intensity|||2.580|0.446|
73838860|NCT00993473|147227231|NON_INFERIORITY_OR_EQUIVALENCE|"Noninferiority would be demonstrated if the upper bound of the 95% confidence interval (CI) for the ratio of the rate of all hypoglycemia in the Lantus group to the rate in the NPH group was \<1.15. Superiority would be demonstrated if the upper bound of the 95% CI was \<1. The margin for noninferiority corresponded to one-half of the 30% difference in hypoglycemia event rate considered as a clinically significant difference by American Diabetes Association 2005 Working Group on Hypoglycemia."|Risk Ratio (RR)|1.18|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.97|1.44|||Generalized Linear Model|"A stepwise closed testing approach was used for the primary all hypoglycemia outcome analysis to assess noninferiority and superiority sequentially."|Risk ratio between treatment groups (Lantus/NPH) estimated by Generalized Linear Model with fixed effect terms for randomization strata and treatment.|"The sample size was calculated to ensure sufficient power so that the upper bound of the 2-sided 95% CI for the Lantus /NPH ratio would not exceed 1.15 based on an expected overall rate of all hypoglycemia of 80 events per patient-year of exposure to NPH insulin and to Lantus. It was planned to randomize at least 45 and up to approximately 60 patients in each of the 2 treatment groups so that at least 70 patients would complete the 24 weeks of treatment."||1.44|0.97|
73838861|NCT01959919|147227251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.907||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between ease of using clotting factor treatment score at Final visit (Month 8) and baseline visit||||0.000
74083854|NCT00706719|147720822|SUPERIORITY_OR_OTHER|||||||0.118|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.118
74083855|NCT00706719|147720822|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.006
74083856|NCT00706719|147720822|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.009
73838862|NCT01959919|147227252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.572|STANDARD_ERROR_OF_MEAN|0.584||0|TWO_SIDED|95.0|3.411|5.733|||t-test, 2 sided|||Comparison between time for reconstructing the drug at Final visit (Month 8) and baseline visit||5.733|3.411|0.000
73838863|NCT01959919|147227253|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.789||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between burden of clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.000
73838864|NCT01959919|147227254|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.98||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between impact of clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.000
73838865|NCT01959919|147227255|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.445||||0.001|||||||Wilcoxon Signed Ranks Test|||Comparison between risk associated with clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.001
73838866|NCT01697501|147227258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7831|TWO_SIDED|95.0|0.29|2.57|||univariate logistic analysis|||||2.57|0.29|0.7831
73838867|NCT01697501|147227259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.1951|TWO_SIDED|95.0|0.66|7.67|||univariate logistic analysis|||||7.67|0.66|0.1951
73838868|NCT01697501|147227260|SUPERIORITY_OR_OTHER|||||||0.2642|TWO_SIDED||||||Wald Chi Square|||||||0.2642
73838869|NCT01697501|147227261|SUPERIORITY_OR_OTHER|||||||0.0672|TWO_SIDED||||||Wald Chi Square|||||||0.0672
73838870|NCT01651208|147227317|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0|||||Chi-squared|||We hypothesized that in the MINT group, at least 70% of subjects will reach an MPR of 0.80 while in the DVD group, the proportion will remain at or below 55%. Our sample size estimates showed that, using a conservative 2-sided test at the 5% Alpha level and a 90% power, we will be able to detect a significant 15% difference (70% - 55%) with a sample of 217 in each study group.||||<0.01
73838871|NCT01651208|147227318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the mean MMAS-4 score is similar in both intervention arms||||<0.01
73838872|NCT02732145|147227334|OTHER|"Question: Determination of sensitivity of the Vulvoscopy Index as a measure of the sensitivity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"The Sensitivity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.000 (Range: 1.0000 - 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
74022090|NCT03093402|147596792|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.408|TWO_SIDED|95.0|-0.27|0.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.40|-0.27|0.408
73838873|NCT02732145|147227334|OTHER|"Question: Determination of specificity of the Vulvoscopy index as a measure of the specificity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||TWO_SIDED|95.0|0.5794|1.0|||||"The Specificity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 - 1.0000)"|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.5794|
73838874|NCT02732145|147227334|OTHER|"Question: Determination of diagnostic accuracy of the Vulvoscopy index as a measure of the diagnostic value of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||TWO_SIDED|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 - 1.0000)"|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.6313|
73838875|NCT02732145|147227334|SUPERIORITY|"Question: Determination of positive predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||TWO_SIDED|95.0|0.227|1.0|||||"Positive predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.2270|
73838876|NCT02732145|147227334|OTHER|"Question: Determination of negative predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"Negative predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
73838877|NCT02732145|147227334|SUPERIORITY|"Question: Is there a difference in the diagnostic accuracy of the Vulvoscopy Index as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the Vulvoscopy Index and histopathology for detection of vulvar dermatosis."||||0.6108
73838878|NCT02732145|147227335|SUPERIORITY|Question: Is there a difference in the frequency of vulvar complaints among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
74022091|NCT03093402|147596792|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.408|TWO_SIDED|95.0|-0.4|0.26||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.26|-0.40|0.408
74022092|NCT03093402|147596792|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.408|TWO_SIDED|95.0|-0.5|0.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.16|-0.50|0.408
73838879|NCT02732145|147227335|SUPERIORITY|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9628|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9628
74022093|NCT03093402|147596793|SUPERIORITY||Mean Difference (Final Values)|-21.48||||0.07|TWO_SIDED|95.0|-37.24|-5.72||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||-5.72|-37.24|0.070
74022094|NCT03093402|147596793|SUPERIORITY||Mean Difference (Final Values)|-10.4||||0.07|TWO_SIDED|95.0|-25.33|4.54||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||4.54|-25.33|0.070
74022095|NCT03093402|147596793|SUPERIORITY||Mean Difference (Final Values)|-10.81||||0.07|TWO_SIDED|95.0|-25.78|4.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||4.16|-25.78|0.070
74022096|NCT03093402|147596794|SUPERIORITY||Median Difference (Final Values)|0.3||||0.979|TWO_SIDED|95.0|-3.38|3.99||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physical Function T-score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||3.99|-3.38|0.979
74022097|NCT03093402|147596794|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.979|TWO_SIDED|95.0|-3.13|3.93||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physical Function T-score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||3.93|-3.13|0.979
74022098|NCT03093402|147596794|SUPERIORITY||Median Difference (Final Values)|0.77||||0.979|TWO_SIDED|95.0|-2.77|4.31||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Physical Function Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||4.31|-2.77|0.979
74022099|NCT03093402|147596795|SUPERIORITY||Mean Difference (Final Values)|-1.44||||0.788|TWO_SIDED|95.0|-6.14|3.26||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||3.26|-6.14|0.788
74083857|NCT00706719|147720822|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.0024
74083858|NCT00706719|147720823|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Baseline.||||0.15
74022100|NCT03093402|147596795|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.788|TWO_SIDED|95.0|-6.07|2.96||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||2.96|-6.07|0.788
74083859|NCT00706719|147720823|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 3.||||0.0067
74083860|NCT00706719|147720823|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 6.||||0.10
74083861|NCT00706719|147720823|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.26
74083862|NCT00706719|147720824|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.880
74083863|NCT00706719|147720824|SUPERIORITY_OR_OTHER|||||||0.612|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.612
74083864|NCT00706719|147720824|SUPERIORITY_OR_OTHER|||||||0.488|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.488
74083865|NCT00706719|147720824|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.054
74083866|NCT00706719|147720825|SUPERIORITY_OR_OTHER|||||||0.705|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.705
74083867|NCT00706719|147720825|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.013
74083868|NCT00706719|147720825|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.004
74083869|NCT00706719|147720825|SUPERIORITY_OR_OTHER|||||||0.808|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.808
74022101|NCT03093402|147596795|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.788|TWO_SIDED|95.0|-4.0|4.94||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||4.94|-4.00|0.788
73838880|NCT02732145|147227335|SUPERIORITY|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9152|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9152
74083870|NCT00706719|147720826|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.008
74083871|NCT00706719|147720826|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.015
74083872|NCT00706719|147720826|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.003
74083873|NCT00706719|147720826|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.109
74083874|NCT04592419|147720827|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept among BRVO participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.87||0.0004|TWO_SIDED|95.02|-3.11|0.3|||Mixed Models Analysis|MMRM model with treatment, visit, treatment × visit interaction, baseline BCVA, disease duration, and geographical location as covariates.||||0.30|-3.11|.0004
74083875|NCT04592419|147720828|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept among BRVO participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.9||0.0243|TWO_SIDED|95.02|-4.24|-0.71|||Mixed Models Analysis|MMRM model treatment, visit, treatment × visit interaction, RVO subtype, baseline BCVA, disease duration, and geographical location as covariates.||||-0.71|-4.24|.0243
74083876|NCT00493792|147720849|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.47|TWO_SIDED|95.0|0.29|1.77|||Regression, Cox|||||1.77|0.29|0.47
74083877|NCT00493792|147720850|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.06|TWO_SIDED|95.0|0.23|1.03|||Regression, Cox|||||1.03|0.23|0.06
74083878|NCT00493792|147720851|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.193|TWO_SIDED|95.0|0.45|1.18|||Regression, Cox|||||1.18|.45|0.193
74083879|NCT02951195|147720858|SUPERIORITY||LS Mean Difference|6.4||||0.0207|TWO_SIDED|95.0|0.3|12.6|||Mixed-effects Model for Repeated Measure|||||12.6|0.3|0.0207
74083880|NCT02951195|147720858|SUPERIORITY||LS Mean Difference|10.5||||0.0002|TWO_SIDED|95.0|5.0|15.9|||Mixed-effects Model for Repeated Measure|||||15.9|5.0|0.0002
74083881|NCT02951195|147720858|SUPERIORITY||LS Mean Difference|8.8||||0.0019|TWO_SIDED|95.0|3.0|14.5|||Mixed-effects Model for Repeated Measure|||||14.5|3.0|0.0019
74083882|NCT02951195|147720858|SUPERIORITY||LS Mean Difference|8.3||||0.054|TWO_SIDED|95.0|-2.1|18.7|||Mixed-effects Model for Repeated Measure|||||18.7|-2.1|0.0540
74083883|NCT02951195|147720859|SUPERIORITY||LS Mean Difference|8.7||||0.0007|TWO_SIDED|95.0|3.7|13.8|||Mixed-effects Model for Repeated Measure|||||13.8|3.7|0.0007
74083884|NCT02951195|147720860|SUPERIORITY||Least Squares (LS) Mean Difference|-19.5||||0.0018|TWO_SIDED|95.0|-32.2|-6.8|||Mixed-effects Model for Repeated Measure|||||-6.8|-32.2|0.0018
74083885|NCT02951195|147720860|SUPERIORITY||LS Mean Difference|-13.6||||0.0106|TWO_SIDED|95.0|-25.0|-2.1|||Mixed-effects Model for Repeated Measure|||||-2.1|-25.0|0.0106
74083886|NCT02951195|147720860|SUPERIORITY||LS Mean Difference|-27.5|||<|0.0001|TWO_SIDED|95.0|-38.6|-16.3|||Mixed-effects Model for Repeated Measure|||||-16.3|-38.6|<0.0001
74083887|NCT02951195|147720860|SUPERIORITY||LS Mean Difference|-24.8||||0.0017|TWO_SIDED|95.0|-40.0|-9.7|||Mixed-effects Model for Repeated Measure|||||-9.7|-40.0|0.0017
74083888|NCT02951195|147720861|SUPERIORITY||LS Mean Difference|-23.9|||<|0.0001|TWO_SIDED|95.0|-33.7|-14.1|||Mixed-effects Model for Repeated Measure|||||-14.1|-33.7|<0.0001
74083889|NCT02951195|147720862|SUPERIORITY||LS Mean Difference|12.5||||0.0166|TWO_SIDED|95.0|1.1|24.0|||Mixed-effects Model for Repeated Measure|||||24.0|1.1|0.0166
74083890|NCT02951195|147720862|SUPERIORITY||LS Mean Difference|21.3|||<|0.0001|TWO_SIDED|95.0|11.2|31.4|||Mixed-effects Model for Repeated Measure|||||31.4|11.2|<0.0001
74083891|NCT02951195|147720862|SUPERIORITY||LS Mean Difference|17.1||||0.0013|TWO_SIDED|95.0|6.3|27.8|||Mixed-effects Model for Repeated Measure|||||27.8|6.3|0.0013
74083892|NCT02951195|147720862|SUPERIORITY||LS Mean Difference|14.5||||0.0563|TWO_SIDED|95.0|-3.8|32.9|||Mixed-effects Model for Repeated Measure|||||32.9|-3.8|0.0563
74083893|NCT02951195|147720863|SUPERIORITY||LS Mean Difference|13.6||||0.0012|TWO_SIDED|95.0|5.3|21.9|||Mixed-effects Model for Repeated Measure|||||21.9|5.3|0.0012
74083894|NCT02951195|147720864|SUPERIORITY||LS Mean Difference|14.1||||0.0476|TWO_SIDED|95.0|-2.6|30.9|||ANCOVA|||||30.9|-2.6|0.0476
74083895|NCT02951195|147720864|SUPERIORITY||LS Mean Difference|29.4||||0.0001|TWO_SIDED|95.0|14.8|44.0|||ANCOVA|||||44.0|14.8|0.0001
74083896|NCT02951195|147720864|SUPERIORITY||LS Mean Difference|26.2||||0.0006|TWO_SIDED|95.0|11.3|41.1|||ANCOVA|||||41.1|11.3|0.0006
74083897|NCT02951195|147720864|SUPERIORITY||LS Mean Difference|4.8||||0.2714|TWO_SIDED|95.0|-11.6|21.2|||Mixed-effects Model for Repeated Measure|||||21.2|-11.6|0.2714
74083898|NCT02951195|147720865|SUPERIORITY||LS Mean Difference|11.3||||0.0138|TWO_SIDED|95.0|1.3|21.2|||Mixed-effects Model for Repeated Measure|||||21.2|1.3|0.0138
74083899|NCT02754492|147720878|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 5.0 × 10\^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|0.989|STANDARD_ERROR_OF_MEAN|0.0107|||ONE_SIDED|95.0|0.95|||||||Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.950|
74083900|NCT02754492|147720878|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 8.0 × 10\^6 for the double platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
73898455|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|2.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
74022102|NCT03093402|147596796|SUPERIORITY||Mean Difference (Final Values)|-1.49||||0.766|TWO_SIDED|95.0|-6.14|3.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||3.16|-6.14|0.766
74022103|NCT03093402|147596796|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.766|TWO_SIDED|95.0|-3.6|5.11||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||5.11|-3.60|0.766
74022104|NCT03093402|147596796|SUPERIORITY||Mean Difference (Final Values)|-1.24||||0.766|TWO_SIDED|95.0|-5.55|3.07||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||3.07|-5.55|0.766
74022105|NCT03093402|147596797|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.982|TWO_SIDED|95.0|-6.04|5.17||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|||5.17|-6.04|0.982
74022106|NCT03093402|147596797|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.982|TWO_SIDED|95.0|-6.22|4.5||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|Each active JBT-101 cohort is compared to placebo.||4.50|-6.22|0.982
74022107|NCT03093402|147596797|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.982|TWO_SIDED|95.0|-6.32|4.36||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|||4.36|-6.32|0.982
74022108|NCT03093402|147596798|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.607|TWO_SIDED|95.0|-4.74|4.91||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||4.91|-4.74|0.607
74088222|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.12|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-1.12|<.0001
74088223|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.0013|TWO_SIDED|95.0|-0.99|-0.24|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.24|-0.99|0.0013
74088224|NCT02709486|147729984|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.25|-0.5|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.25|<.0001
74088225|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.96|-0.45|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.45|-0.96|<.0001
74088226|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0004|TWO_SIDED|95.0|-0.73|-0.21|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.73|0.0004
74022109|NCT03093402|147596798|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.607|TWO_SIDED|95.0|-1.85|7.71||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||7.71|-1.85|0.607
74022110|NCT03093402|147596798|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.607|TWO_SIDED|95.0|-3.22|6.09||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||6.09|-3.22|0.607
74022111|NCT03093402|147596799|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.981|TWO_SIDED|95.0|-4.66|4.3||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.30|-4.66|0.981
74022112|NCT03093402|147596799|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.981|TWO_SIDED|95.0|-3.84|4.86||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.86|-3.84|0.981
74022113|NCT03093402|147596799|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.981|TWO_SIDED|95.0|-4.62|4.08||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.08|-4.62|0.981
74022114|NCT03093402|147596800|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.653|TWO_SIDED|95.0|-6.0|2.29||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||2.29|-6.00|0.653
74022115|NCT03093402|147596800|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.653|TWO_SIDED|95.0|-3.1|4.88||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||4.88|-3.10|0.653
74022116|NCT03093402|147596800|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.653|TWO_SIDED|95.0|-4.31|3.67||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||3.67|-4.31|0.653
74022117|NCT03093402|147596801|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.245|TWO_SIDED|95.0|-2.56|0.29||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.29|-2.56|0.245
74083901|NCT02754492|147720878|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 12.0 × 10\^6 for the triple platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
74083902|NCT02754492|147720879|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10\^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.989|STANDARD_ERROR_OF_MEAN|0.0107|||ONE_SIDED|95.0|0.95|||||||Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.950|
73838881|NCT02732145|147227335|SUPERIORITY|Question: Is there a difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
73838882|NCT02732145|147227335|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with vulvar dermatosis diagnosed with vulvoscopy and histopathology?||||||0.8862|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8862
73838883|NCT02732145|147227335|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
73838884|NCT02732145|147227335|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3319|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3319
74022118|NCT03093402|147596801|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.245|TWO_SIDED|95.0|-1.93|0.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.80|-1.93|0.245
74022119|NCT03093402|147596801|SUPERIORITY||Mean Difference (Final Values)|-1.28||||0.245|TWO_SIDED|95.0|-2.64|0.09||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.09|-2.64|0.245
74022120|NCT03093402|147596802|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.608|TWO_SIDED|95.0|-4.45|3.54||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||3.54|-4.45|0.608
74022121|NCT03093402|147596802|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.608|TWO_SIDED|95.0|-2.27|5.47||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||5.47|-2.27|0.608
74022122|NCT03093402|147596802|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.608|TWO_SIDED|95.0|-2.25|5.45||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||5.45|-2.25|0.608
74022123|NCT01656772|147596857|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin d = -0.05. The null hypothesis was to be rejected if Z \> 1.645 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0405|TWO_SIDED|||||Adjusted to take into account the correlation between multiple PVs on the same subject. The sample estimate of the intraclass correlation coefficient was calculated as the Pearson sample correlation coefficient for all pairs of observations.|Farrington and Manning|||The primary effectiveness endpoint is the successful navigation and EGM recording of each pre-specified pulmonary vein (PV). The RF ablation treatment was not part of the investigational procedure. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject.||||0.0405
74022124|NCT01656772|147596858|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin d= 0.07. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z \< -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0441|TWO_SIDED||||||Z-statistic|||||||.0441
74022125|NCT01651780|147596859|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.77||||0.2692|TWO_SIDED|95.0|0.48|1.23|||Chi-squared|||||1.23|0.48|0.2692
74022126|NCT01651780|147596860|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.89||||0.4967|TWO_SIDED|95.0|0.64|1.24|||Chi-squared|||||1.24|0.64|0.4967
74022127|NCT03359902|147596906|SUPERIORITY||beta|1.4||||0.11|TWO_SIDED||||||Mixed Models Analysis|||"A linear mixed effects model was conducted to account for carryover and order effects in this crossover trial.~Assuming α = 0.05, two-sided test, and 60 participants in total. If the carryover effect is negligible, we will have 90% power to detect an effect size of 0.604 for memory improvement"||||0.11
74022128|NCT02930174|147596909|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.26|TWO_SIDED||||||ANOVA|||||||0.26
74083903|NCT02754492|147720879|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10\^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
74088227|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.04|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.49|-1.04|<.0001
74088228|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.08|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.08|<.0001
73838885|NCT02732145|147227335|SUPERIORITY|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8662|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8662
73838886|NCT02732145|147227335|SUPERIORITY|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
73838887|NCT02732145|147227336|SUPERIORITY|Question: Is there a difference in the frequency of vulvar complaints among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5399|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5399
73838888|NCT02732145|147227336|SUPERIORITY|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9248
73838889|NCT02732145|147227336|SUPERIORITY|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9839
73838890|NCT02732145|147227336|SUPERIORITY|Question: Is there a difference in the frequency of any lesion in any vulvar ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7537|||||||t|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.7537
73838891|NCT02732145|147227336|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2054|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.2054
73838892|NCT02732145|147227336|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6409|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.6409
73838893|NCT02732145|147227336|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9753
73838894|NCT02732145|147227336|SUPERIORITY|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8986|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8986
73838895|NCT02732145|147227336|SUPERIORITY|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0017|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).||||0.0017
73838896|NCT02732145|147227337|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
73838897|NCT02732145|147227337|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index (mean) among patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9899|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9899
73838898|NCT02732145|147227337|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9686|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9686
73838899|NCT02732145|147227337|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7055|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.7055
73838900|NCT02732145|147227337|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8852|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8852
73838901|NCT02732145|147227337|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
73838902|NCT02732145|147227337|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3351|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3351
73838903|NCT02732145|147227337|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8673
73838904|NCT02732145|147227337|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8673
73838905|NCT02732145|147227337|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (mean) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
73898456|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.395||0.429|TWO_SIDED|95.0|-1.09|0.464||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.464|-1.090|0.429
73898457|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|3.13|||TWO_SIDED|||||||||Week 96||||
73838906|NCT02732145|147227337|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8472|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8472
74083904|NCT02754492|147720879|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10\^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
73838907|NCT02732145|147227339|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
73838908|NCT02732145|147227339|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9629|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9629
73838909|NCT02732145|147227339|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9155|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9155
73838910|NCT02732145|147227339|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.4913|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.4913
73838911|NCT02732145|147227339|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8866|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8866
73838912|NCT02732145|147227339|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
73838913|NCT02732145|147227339|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3335|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3335
73838914|NCT02732145|147227339|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8666
73838915|NCT02732145|147227339|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8666
73838916|NCT02732145|147227339|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (median) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
73838917|NCT02732145|147227339|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8144|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8144
73838918|NCT02732145|147227340|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5403|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5403
73838919|NCT02732145|147227340|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9248
73838920|NCT02732145|147227340|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9839
73838921|NCT02732145|147227340|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5124|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5124
73838922|NCT02732145|147227340|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2058|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.2058
73838923|NCT02732145|147227340|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6412|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.6412
73898458|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.389||0.597|TWO_SIDED|95.0|-0.559|0.97||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.970|-0.559|0.597
73838924|NCT02732145|147227340|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9753
73838925|NCT02732145|147227340|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3621|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3621
73838926|NCT02732145|147227340|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8987|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8987
73838927|NCT02732145|147227340|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar lesions specific for dermatosis (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).||||0.0018
73838928|NCT02732145|147227340|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.4409|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.4409
73838929|NCT02732145|147227341|OTHER|"Question: Determination of sensitivity of the N-S-P Scheme as a measure of the sensitivity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"The Sensitivity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
73838930|NCT02732145|147227341|OTHER|"Question: Determination of specificity of the N-S-P Scheme as a measure of the specificity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||TWO_SIDED|95.0|0.5794|1.0|||||"The Specificity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 - 1.0000)."|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.5794|
73838931|NCT02732145|147227341|OTHER|"Question: Determination of diagnostic accuracy of the N-S-P Scheme as a measure of the diagnostic value of the Three Rings Vulvoscopy, in relation to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||TWO_SIDED|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 - 1.0000)."|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.6313|
73838932|NCT02732145|147227341|OTHER|"Question: Determination of positive predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||TWO_SIDED|95.0|0.227|1.0|||||"Positive predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.2270|
73838933|NCT02732145|147227341|OTHER|"Question: Determination of negative predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"Negative predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
73838934|NCT02732145|147227341|SUPERIORITY|"Question: Is there a difference in the diagnostic accuracy of the N-S-P Scheme as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the N-S-P Scheme and histopathology for detection of vulvar dermatosis."||||0.6108
73838935|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9286|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9286
73838936|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8618|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8618
73838937|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9786|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9786
73838938|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
73838939|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8634|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8634
73838940|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7992|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.7992
73838941|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.3912|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.3912
73898459|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|2.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898460|NCT02880956|147328893|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.4||0.86|TWO_SIDED|95.0|-0.717|0.858||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.858|-0.717|0.860
73838942|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6152|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6152
73838943|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6108
73838944|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
73838945|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7912|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.7912
73838946|NCT02732145|147227342|SUPERIORITY|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
73838947|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.253|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.2530
73838948|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8338|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8338
73838949|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0019|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0019
73838950|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6541|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6541
73838951|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8224|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8224
73838952|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0064|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0064
73838953|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9723|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9723
73838954|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8161|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8161
73838955|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.1165|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.1165
73838956|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6339|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6339
73959647|NCT00430300|147454770|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.6562|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.6562
73838957|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9724|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9724
73838958|NCT02732145|147227343|SUPERIORITY|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0016|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0016
73838959|NCT02732145|147227344|EQUIVALENCE|Question: Is there a difference in the age of patients from different groups?||||||0|||||||ANOVA|||Parameter: The difference in the age of patients from different groups.||||0.0000
73838960|NCT02732145|147227345|EQUIVALENCE|Is there a difference in the weight of patients from different groups?||||||0|||||||ANOVA|||The difference in the weight of patients from different groups.||||0.0000
73838961|NCT02732145|147227346|EQUIVALENCE|Is there a difference in the height of patients from different groups.||||||0.0557|||||||ANOVA|||The difference in the height of patients from different groups.||||0.0557
73838962|NCT02732145|147227347|EQUIVALENCE|Is there a difference in the body mass index of patients from different groups.||||||0|||||||ANOVA|||The difference in the body mass index of patients from different groups.||||0.0000
73838963|NCT02732145|147227348|EQUIVALENCE|Question: Is there a difference in the incidence of patients older than 65 years in different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of patients older than 65 years between different groups.||||0.0000
73838964|NCT02732145|147227348|EQUIVALENCE|Question: Is there a difference in the incidence of menopausal patients among different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of menopausal patients among different groups.||||0.0000
73838965|NCT02732145|147227348|EQUIVALENCE|Question: Is there a difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.||||||0.3708|||||||Chi-squared|||Parameter: The difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.||||0.3708
73838966|NCT02732145|147227348|EQUIVALENCE|Question: Is there a difference in the incidence of patients educated equally or less than 12 years among different groups?||||||0.018|||||||Chi-squared|||Parameter: The difference in the incidence of patients educated equally or less than 12 years among different groups.||||0.0180
73838967|NCT02732145|147227348|EQUIVALENCE|Question: Is there a difference in marital status among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of marital status among patients from different groups.||||0.0000
73838968|NCT02732145|147227348|EQUIVALENCE|Question: Is there a difference in the nulliparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the nulliparity among patients from different groups.||||0.0000
73838969|NCT02732145|147227348|EQUIVALENCE|Question: Is there a difference in the multiparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the multiparity among patients from different groups.||||0.0000
73838970|NCT02732145|147227348|EQUIVALENCE|Question: Is there a difference in the number of abortions among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the number of abortions among patients from different groups.||||0.0000
73838971|NCT02732145|147227348|EQUIVALENCE|Question: Is there a difference in the using of contraception among patients from different groups?||||||0.1323|||||||Chi-squared|||Parameter: The difference in the using of contraception among patients from different groups.||||0.1323
73838972|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva among patients with vulvar discomfort?||||||0.3158|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) among patients with vulvar discomfort.||||0.3158
73838973|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of symptoms of the sharp pain of the vulva among patients with vulvar discomfort?||||||0.0007|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp pain in the vulva (stabbing, sticking, knife-like pain, paper-cuts pain) among patients with vulvar discomfort.||||0.0007
73838974|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvar dermatosis.||||0.0000
73838975|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvodynia.||||0.0000
73838976|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar burning among patients with vulvar discomfort?||||||0.0147|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar burning among patients with vulvar discomfort.||||0.0147
73838977|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar stinging among patients with vulvar discomfort?||||||0.8456|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar stinging among patients with vulvar discomfort.||||0.8456
73838978|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar soreness among patients with vulvar discomfort?||||||0.0076|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar soreness among patients with vulvar discomfort.||||0.0076
73838979|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of irritation of the vulva among the patients with vulvar discomfort?||||||0.0423|||||||Chi-squared|||Parameter: The difference in the incidence of irritation of the vulva among patients with vulvar discomfort.||||0.0423
73838980|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of the knife-like pain in the vulva among the patients with vulvar discomfort?||||||0.0457|||||||Chi-squared|||Parameter: The difference in the incidence of the knife-like pain in the vulva among patients with vulvar discomfort.||||0.0457
73838981|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of the paper-cuts pain of the vulva among the patients with vulvar discomfort?||||||0.043|||||||Chi-squared|||Parameter: The difference in the incidence of the paper-cuts pain of the vulva among patients with vulvar discomfort.||||0.0430
73838982|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of the stabbing of the vulva among the patients with vulvar discomfort?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of the stabbing of the vulva among patients with vulvar discomfort.||||0.0134
73838983|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of sticking of the vulva among the patients with vulvar discomfort?||||||0.0581|||||||Chi-squared|||Parameter: The difference in the incidence of sticking of the vulva among patients with vulvar discomfort.||||0.0581
73838984|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of itching of the vulva among the patients with vulvar discomfort?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the incidence of itching of the vulva among patients with vulvar discomfort.||||0.0002
73838985|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of the feeling of inflammation of the vulva among the patients with vulvar discomfort?|t-test proportion|0.0||||0.0852|TWO_SIDED||||||Chi-squared|||Parameter: The difference in the incidence of the feeling of inflammation of the vulva among patients with vulvar discomfort.||||0.0852
73838986|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the incidence of aching of the vulva among the patients with vulvar discomfort?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of aching of the vulva among patients with vulvar discomfort.||||0.0001
73838987|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the association of different symptoms of the vulva among the patients with vulvar discomfort?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of association of different vulvar symptoms among patients with vulvar discomfort.||||0.0000
73838988|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvar dermatosis.||||0.0000
73838989|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus stinging in the patients with vulvar dermatosis?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus stinging in patients with vulvar dermatosis.||||0.0008
73838990|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvar dermatosis.||||0.0000
73838991|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvar dermatosis.||||0.0000
73838992|NCT02732145|147227349|SUPERIORITY|||||||0||||||There was a statistically significant difference at p\<0.001. Patients with vulvar dermatosis had significantly more often itching than the feeling of inflammation of the vulva.|t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0000
73838993|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvar dermatosis.||||0.0000
73838994|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvar dermatosis.||||0.0000
73838995|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvar dermatosis.||||0.0000
73838996|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvar dermatosis.||||0.0000
73838997|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0000
73838998|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvar dermatosis.||||0.0000
73838999|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvar dermatosis?||||||0.8591|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvar dermatosis.||||0.8591
73839000|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvar dermatosis?||||||0.009|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvar dermatosis.||||0.0090
73839001|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvar dermatosis?||||||0.0212|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvar dermatosis.||||0.0212
73839002|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0.0057|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0057
73839003|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0977|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.0977
73839004|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0143|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.0143
73839005|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvar dermatosis who had sharp vulvar pain.||||0.2059
73839006|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.682|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.6820
73839007|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.2059
73839008|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvodynia.||||0.0000
73839009|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvodynia?||||||0.0344|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvodynia.||||0.0344
73839010|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvodynia?||||||0.0023|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvodynia.||||0.0023
73839011|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus itching in the patients with vulvodynia?||||||0.5675|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus itching in patients with vulvodynia.||||0.5675
73839012|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvodynia?||||||0.0037|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvodynia.||||0.0037
73959648|NCT00430300|147454770|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.5632|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.5632
73839013|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvodynia?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvodynia.||||0.0005
73839014|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvodynia.||||0.0000
73839015|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvodynia?||||||0.1201|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvodynia.||||0.1201
73839016|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvodynia?||||||0.0123|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvodynia.||||0.0123
73839017|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus the feeling of inflammation in the patients with vulvodynia?||||||0.0188|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvodynia.||||0.0188
73839018|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvodynia?||||||0.003|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvodynia.||||0.0030
73839019|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvodynia?||||||0.2155|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvodynia.||||0.2155
73839020|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvodynia?||||||0.1508|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvodynia.||||0.1508
73839021|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvodynia?||||||0.6364|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvodynia.||||0.6364
73839022|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvodynia?||||||0.5277|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvodynia.||||0.5277
73839023|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.2041|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.||||0.2041
73839024|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.0412|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.||||0.0412
73839025|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvodynia who had sharp vulvar pain?||||||0.7978|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvodynia who had sharp vulvar pain.||||0.7978
73839026|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.3094|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.||||0.3094
73839027|NCT02732145|147227349|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.073|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.||||0.0730
73839028|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis and vulvodynia?||||||0.4038|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis or vulvodynia.||||0.4038
73839029|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis and vulvodynia?||||||0.7299|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis or vulvodynia.||||0.7299
73839030|NCT02732145|147227349|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis and vulvodynia?||||||0.7241|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis or vulvodynia.||||0.7241
73839031|NCT02732145|147227350|EQUIVALENCE|Question: Is there a difference in the sexual activity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the sexual activity among patients from different groups.||||0.0000
73839032|NCT02732145|147227350|EQUIVALENCE|Question: Is there a difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups?||||||0.0006|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups.||||0.0006
73839033|NCT02732145|147227350|EQUIVALENCE|Question: Is there a difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups.||||0.0000
73839034|NCT02732145|147227351|EQUIVALENCE|Question: Is there a difference in the frequency of dyspareunia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia among patients from different groups.||||0.0000
73839035|NCT02732145|147227351|EQUIVALENCE|Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.||||||0.2999|||||||Chi-squared|||Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.||||0.2999
73839036|NCT02732145|147227352|EQUIVALENCE|Question: Is there a difference in the incidence of the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis.||||0.0000
73839037|NCT02732145|147227352|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis?||||||0.0347|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis.||||0.0347
73839038|NCT02732145|147227352|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.7068|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis.||||0.7068
73898461|NCT02880956|147328893|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898462|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.497||0.854|TWO_SIDED|95.0|-1.069|0.885||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.885|-1.069|0.854
73839039|NCT02732145|147227352|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.0025|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis.||||0.0025
73839040|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis.||||0.0000
73839041|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons?||||||0.6552|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons.||||0.6552
73839042|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis.||||0.0002
73839043|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle?||||||0.2877|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle.||||0.2877
73839044|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia.||||0.0001
73839045|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes?||||||0.4754|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes.||||0.4754
73839046|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age?||||||0.1082|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age.||||0.1082
73839047|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age?||||||0.0179|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age.||||0.0179
73839048|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age?||||||0.5722|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age.||||0.5722
73839049|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age?||||||0.6148|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age.||||0.6148
73839050|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age?||||||0.5307|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age.||||0.5307
73898463|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73839051|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort during urination?||||||0.1546|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during urination.||||0.1546
73839052|NCT02732145|147227353|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active?||||||0.1019|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active.||||0.1019
73839053|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of problems associated with urination and defecation between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of problems associated with urination and defecation between patients from different groups.||||0.0000
73839054|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of dysuria between patients from different groups.||||0.0000
73839055|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent dysuria between patients from different groups.||||0.0000
73839056|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of frequent dysuria between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent dysuria between patients from different groups.||||0.0003
73839057|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of urinary incontinence between patients from different groups?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of urinary incontinence between patients from different groups.||||0.0010
73839058|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent urinary incontinence between patients from different groups?||||||0.1859|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urinary incontinence between patients from different groups.||||0.1859
73839059|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of frequent urinary incontinence between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urinary incontinence between patients from different groups.||||0.0003
74083905|NCT04010227|147720970|SUPERIORITY||partial correlation|0.08||||0.6|TWO_SIDED|95.0|-0.23|0.4||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. multiply imputed data were used in analyses.||||0.40|-0.23|0.60
73839060|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of difficulties at starting urination between patients from different groups?||||||0.0015|||||||Chi-squared|||Parameter: The difference in the incidence of difficulties at starting urination between patients from different groups.||||0.0015
73839061|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent difficulties at starting urination between patients from different groups?||||||0.0013|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent difficulties at starting urination between patients from different groups.||||0.0013
74083906|NCT04010227|147720971|SUPERIORITY||partial correlation|0.02||||0.96|TWO_SIDED|95.0|-0.29|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.34|-0.29|0.96
74083907|NCT04010227|147720972|SUPERIORITY||partial correlation|0.06||||0.75|TWO_SIDED|95.0|-0.25|0.38||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.38|-0.25|0.75
74083908|NCT04010227|147720973|SUPERIORITY||partial correlation|0.09||||0.33|TWO_SIDED|95.0|-0.23|0.4||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.40|-0.23|0.33
73839062|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of frequent difficulties at starting urination between patients from different groups?||||||0.5673|||||||Chi-squared|||Parameter: The difference in the incidence of frequent difficulties at starting urination between patients from different groups.||||0.5673
73839063|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of urgency between patients from different groups?||||||0.0065|||||||Chi-squared|||Parameter: The difference in the incidence of urgency between patients from different groups.||||0.0065
73839064|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent urgency between patients from different groups?||||||0.083|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urgency between patients from different groups.||||0.0830
73839065|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of frequent urgency between patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urgency between patients from different groups.||||0.0001
73839066|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of nocturia between patients from different groups.||||0.0000
73839067|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent nocturia between patients from different groups?||||||0.2315|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent nocturia between patients from different groups.||||0.2315
73839068|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of frequent nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of frequent nocturia between patients from different groups.||||0.0000
73839069|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of recurrent cystitis between patients from different groups?||||||0.0539|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent cystitis between patients from different groups.||||0.0539
73839070|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of constipation between patients from different groups?||||||0.0379|||||||Chi-squared|||Parameter: The difference in the incidence of constipation between patients from different groups.||||0.0379
73839071|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent constipation between patients from different groups?||||||0.1485|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent constipation between patients from different groups.||||0.1485
73839072|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of frequent constipation between patients from different groups?||||||0.4155|||||||Chi-squared|||Parameter: The difference in the incidence of frequent constipation between patients from different groups.||||0.4155
73839073|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of diarrhea between patients from different groups?||||||0.0092|||||||Chi-squared|||Parameter: The difference in the incidence of diarrhea between patients from different groups.||||0.0092
73839074|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent diarrhea between patients from different groups?||||||0.0192|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent diarrhea between patients from different groups.||||0.0192
73839075|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of frequent diarrhea between patients from different groups?||||||0.5253|||||||Chi-squared|||Parameter: The difference in the incidence of frequent diarrhea between patients from different groups.||||0.5253
73839076|NCT02732145|147227354|EQUIVALENCE|Question: Is there a difference in the incidence of the irritable colon between patients from different groups?||||||0.006|||||||Chi-squared|||Parameter: The difference in the incidence of the irritable colon between patients from different groups.||||0.0060
73839077|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of any associated symptom or disease among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of any associated symptom or disease among patients from different groups.||||0.0000
73839078|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of a frequent headache among patients from different groups?||||||0.3957|||||||Chi-squared|||Parameter: The difference in the incidence of a frequent headache among patients from different groups.||||0.3957
73839079|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of chronic fatigue among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of chronic fatigue among patients from different groups.||||0.0000
73839080|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of lumbar pain among patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of lumbar pain among patients from different groups.||||0.0001
73839081|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of fibromyalgia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of fibromyalgia among patients from different groups.||||0.0000
73839082|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of energy loss among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of energy loss among patients from different groups.||||0.0000
73839083|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of sleep disorders among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of sleep disorders among patients from different groups.||||0.0000
73839084|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of pelvic pain among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of pelvic pain among patients from different groups.||||0.0000
73839085|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of unintended weight loss among patients from different groups?||||||0.1764|||||||Chi-squared|||Parameter: The difference in the incidence of unintended weight loss among patients from different groups.||||0.1764
73839086|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of endometriosis among patients from different groups?||||||0.3127|||||||Chi-squared|||Parameter: The difference in the incidence of endometriosis among patients from different groups.||||0.3127
73839087|NCT02732145|147227355|EQUIVALENCE|"Question: Is there a difference in the incidence of D-D-D Triad among patients from different groups?"||||||0.0028|||||||Chi-squared|||"Parameter: The difference in the difference in the incidence of D-D-D Triad (Dysmenorrhoea-Dyspareunia-Dysuria) among patients from different groups."||||0.0028
73839088|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of hypertension among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of hypertension among patients from different groups.||||0.0000
73839089|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of genital herpes among patients from different groups?||||||0.9323|||||||Chi-squared|||Parameter: The difference in the incidence of genital herpes among patients from different groups.||||0.9323
73839090|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of thyroid disease among patients from different groups?||||||0.0011|||||||Chi-squared|||Parameter: The difference in the incidence of thyroid disease among patients from different groups.||||0.0011
73839091|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of drug allergy among patients from different groups?||||||0.2756|||||||Chi-squared|||Parameter: The difference in the incidence of drug allergy among patients from different groups.||||0.2756
73839092|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of recurrent attacks of sinusitis among patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent attacks of sinusitis among patients from different groups.||||0.0105
73839093|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of HPV infection among patients from different groups, who were tested for HPV?||||||0.2128|||||||Chi-squared|||Parameter: The difference in the incidence of HPV infection among patients from different groups, who were tested for HPV.||||0.2128
73839094|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of abnormal PAP smear among patients from different groups?||||||0.0018|||||||Chi-squared|||Parameter: The difference in the incidence of abnormal PAP smear among patients from different groups.||||0.0018
73839095|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of genital warts among patients from different groups?||||||0.2524|||||||Chi-squared|||Parameter: The difference in the incidence of genital warts among patients from different groups.||||0.2524
73839096|NCT02732145|147227355|EQUIVALENCE|Question: Is there a difference in the incidence of conization or LETZ among patients from different groups?||||||0.2452|||||||Chi-squared|||Parameter: The difference in the incidence of conization or LETZ among patients from different groups.||||0.2452
73839097|NCT02732145|147227356|SUPERIORITY|Question: Is there a difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia?||||||0.1583|||||||Chi-squared|||Parameter: The difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia.||||0.1583
73839098|NCT02732145|147227356|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.038|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antifungals among patients with vulvar dermatosis and vulvodynia.||||0.0380
73839099|NCT02732145|147227356|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antifungals among patients with vulvar dermatosis and vulvodynia.||||0.6468
73839100|NCT02732145|147227356|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.467|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.||||0.4670
73839101|NCT02732145|147227356|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.2131|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.||||0.2131
73839102|NCT02732145|147227356|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with corticosteroids between the patients with vulvar dermatosis and vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with corticoids among patients with vulvar dermatosis and vulvodynia.||||0.0000
73839103|NCT02732145|147227356|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antidepressant between the patients with vulvar dermatosis and vulvodynia?||||||0.0962|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antidepressant among patients with vulvar dermatosis and vulvodynia.||||0.0962
73839104|NCT02732145|147227357|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups.||||0.0000
73839105|NCT02732145|147227357|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups.||||0.0000
73839106|NCT02732145|147227357|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups.||||0.0000
73839107|NCT02732145|147227357|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups.||||0.0000
73839108|NCT02732145|147227357|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups.||||0.0000
73839109|NCT02732145|147227357|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups.||||0.0000
74022129|NCT02930174|147596910|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.342|TWO_SIDED||||||ANOVA|||||||0.342
74022130|NCT02930174|147596911|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.184|TWO_SIDED||||||ANOVA|||||||0.184
74083909|NCT04010227|147720974|SUPERIORITY||partial correlation|0.03||||0.91|TWO_SIDED|95.0|-0.29|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.34|-0.29|0.91
74083910|NCT04010227|147720975|SUPERIORITY||partial correlation|0.06||||0.74|TWO_SIDED|95.0|-0.25|0.38||P-value for study group x time interaction for patient physical quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.38|-0.25|0.74
73839110|NCT02732145|147227357|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups.||||0.0000
73839111|NCT02732145|147227357|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva?||||||0.0009|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva.||||0.0009
73839112|NCT02732145|147227357|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva?||||||0.0289|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva.||||0.0289
73839113|NCT02732145|147227357|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis versus normal vulva?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis and normal vulva.||||0.0134
74083911|NCT04010227|147720975|SUPERIORITY||partial correlation|0.14||||0.24|TWO_SIDED|95.0|-0.18|0.45||P-value for study group x time interaction for patient psychological quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.45|-0.18|0.24
73839114|NCT02732145|147227357|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis versus normal vulva?||||||0.0037|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis and normal vulva.||||0.0037
73839115|NCT02732145|147227357|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva?||||||0.008|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva.||||0.0080
73839116|NCT02732145|147227357|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis versus normal vulva?||||||0.0579|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis and normal vulva.||||0.0579
73839117|NCT02732145|147227357|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis versus normal vulva?||||||0.072|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis and normal vulva.||||0.0720
73839118|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839119|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839120|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839121|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839122|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73959649|NCT00430300|147454770|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.637|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.6370
73959650|NCT00430300|147454770|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.4686|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.4686
73959651|NCT00430300|147454770|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.6164|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.6164
73959652|NCT00430300|147454778|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.9885|ONE_SIDED|95.0|-2.4||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.4|0.9885
73839123|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73898464|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.491||0.412|TWO_SIDED|95.0|-1.368|0.562||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.562|-1.368|0.412
73959653|NCT00430300|147454778|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.8055|ONE_SIDED|95.0|-1.5||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.5|0.8055
73959654|NCT00430300|147454778|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.5||0.9759|ONE_SIDED|95.0|-2.0||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.0|0.9759
73839124|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839125|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of fissures the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839126|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
74022131|NCT02930174|147596912|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.283|TWO_SIDED||||||ANOVA|||||||0.283
73839127|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the frequency of smoothness of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839128|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Inner Vulvar Ring between patients within different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
74022132|NCT02930174|147596913|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.204|TWO_SIDED||||||ANOVA|||||||0.204
74022133|NCT02930174|147596914|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.136|TWO_SIDED||||||ANOVA|||||||0.136
74022134|NCT00151892|147596915|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 2-sided 95% confidence interval (CI) for the difference in the percentages of subjects in remission at 6 months of the two treatment groups will be computed. Non-inferiority of SPD476 to Asacol will be concluded if the lower limit of the 95% CI lies above the non-inferiority margin of -10%.|Difference in proportions|0.02||||||95.0|-0.04|0.08||||||The null hypothesis to be tested is that the true difference in proportions is less than or equal to -10%.||0.08|-0.04|
74022135|NCT03303989|147596924|SUPERIORITY|Efficacy of MMF was examined by the proportion of responders in MMF+Peg compared to PBO+Peg. Rates of the primary outcome were compared using proportions and 95% confidence intervals and tested for differences using Fisher's exact test.|||||<|0.01|TWO_SIDED|95.0|||||Fisher Exact|||Fisher's exact tests were performed to compare baseline and clinical characteristics between treatment groups as appropriate.||||<0.01
74083912|NCT04010227|147720975|SUPERIORITY||partial correlation|0.06||||0.78|TWO_SIDED|95.0|-0.26|0.37||P-value for study group x time interaction for patient existential quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.37|-0.26|0.78
74022136|NCT01272583|147596925|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||1.0
74022137|NCT01272583|147596926|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||GLP-1 intact|ANOVA|The Friedman Test was used for ANOVA||||||<0.001
74022138|NCT01272583|147596926|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||GLP-1 Total|ANOVA|The Friedman Test was used for ANOVA.||||||0.98
74022139|NCT01272583|147596926|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||GIP intact|ANOVA|The Friedman Test was used for ANOVA.||||||0.049
74083913|NCT04010227|147720975|SUPERIORITY||partial correlation|0.13||||0.29|TWO_SIDED|95.0|-0.19|0.44||P-value for study group x time interaction for patient social quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.44|-0.19|0.29
73898465|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|4.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74022140|NCT01272583|147596926|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||GIP total|ANOVA|The Friedman Test was used for ANOVA||||||0.44
74022141|NCT01272583|147596927|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.14
74022142|NCT01272583|147596928|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.98
74022143|NCT01272583|147596929|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.22
74022144|NCT01272583|147596930|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.01
74083914|NCT04010227|147720976|SUPERIORITY||partial correlation|0.03||||0.92|TWO_SIDED|95.0|-0.28|0.35||P-value for study group x time interaction for caregiver physical quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.35|-0.28|0.92
74022145|NCT01272583|147596930|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Dunn's Multiple Comparison Test|Post Hoc testing||||||<0.05
74022146|NCT01272583|147596931|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.76
74022147|NCT00891202|147596988|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-30.03|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|95.0|-36.82|-23.24|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model fitted with treatment and baseline spleen severity (low spleen severity: spleen volume less than or equal to \[\<=\] 20 multiples of normal spleen volume, high spleen severity: spleen volume greater than \[\>\] 20 multiples of normal spleen volume).||-23.24|-36.82|<0.0001
74022148|NCT04108429|147597005|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8||||.830
74022149|NCT04108429|147597006|SUPERIORITY|||||||0.759|||||||Mixed Models Analysis|||generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8||||.759
74022150|NCT04108429|147597007|SUPERIORITY|||||||0.275|||||||Simulation Modeling Analysis (SMA) for T|||Counseling center utilization data were examined using Simulation Modeling Analysis (SMA) for Time-Series data to determine if there were changes in utilization between the pre-implementation and implementation phases. SMA evaluates the statistical significance of between-phase changes in data streams and also accounts for the presence of autocorrelation (the non-independence of data points in time-series data streams).||||.275
74022151|NCT04108429|147597009|SUPERIORITY|generalized linear mixed model||||||0.002|||||||Mixed Models Analysis|||||||.002
74022152|NCT04108429|147597010|SUPERIORITY|||||||0.489|||||||Mixed Models Analysis|||generalized linear mixed model||||.489
73959655|NCT00430300|147454778|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.4401|ONE_SIDED|95.0|-1.1||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.1|0.4401
73959656|NCT00430300|147454778|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.5957|ONE_SIDED|95.0|-1.4||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.4|0.5957
73959657|NCT00430300|147454778|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.8302|ONE_SIDED|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.7|0.8302
73959658|NCT00430300|147454778|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.9657|ONE_SIDED|95.0|-3.1||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-3.1|0.9657
73959659|NCT00430300|147454778|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.6378|ONE_SIDED|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.7|0.6378
73959660|NCT00430300|147454778|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.8||0.899|ONE_SIDED|95.0|-2.2||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.2|0.8990
73959661|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.15||0.8757|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.8757
73959662|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.6334|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6334
73959663|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.5448|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.5448
73959664|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.6986|ONE_SIDED|95.0|-0.34||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.34|0.6986
73959665|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.16||0.3151|ONE_SIDED|95.0|-0.18||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.18|0.3151
74022153|NCT04108429|147597011|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||generalized linear mixed model||||.001
74022154|NCT01431287|147597081|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.108|0.157||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.157|0.108|<0.0001
73839129|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of ischemia of the Middle Vulvar Ring between patients from different groups?||||||0.0632|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0632
73839130|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of ischemia of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839131|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of punctuation of the Middle Vulvar Ring between patients within different groups?||||||0.0043|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0043
73839132|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of punctuation of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Typ), evaluated with Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839133|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of papillae of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of papillae of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839134|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.0697|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.||||0.0697
73839135|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0319|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0319
73839136|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.7273|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.7273
73839137|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
73839138|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
73839139|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia?||||||0.2203|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.2203
73839140|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin.||||0.0000
73839141|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.||||0.0000
73839142|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0.1456|||||||t-test proportion|||Parameter: The incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.||||0.1456
73839143|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.1133|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.||||0.1133
73839144|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0000
73839145|NCT02732145|147227358|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0058|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0058
73839146|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Mons pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73839147|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73839148|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73839149|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73839150|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73839151|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73839152|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73839153|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73839154|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
74083915|NCT04010227|147720976|SUPERIORITY||partial correlation|0.06||||0.79|TWO_SIDED|95.0|-0.26|0.37||P-value for study group x time interaction for caregiver psychological quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.37|-0.26|0.79
73839155|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of Mons Pubis among patients from different groups?||||||0.0016|||||||Chi-squared|||"Parameter: The incidence of rhagades of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0016
73839156|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73898466|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.503||0.262|TWO_SIDED|95.0|-1.554|0.424||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.424|-1.554|0.262
73839157|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73839158|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0014|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis.||||0.0014
73839159|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0000
73839160|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0414|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0414
73839161|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia?||||||0.0898|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0898
73839162|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0008|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0008
73959666|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.14||0.1802|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.1802
73959667|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.9102|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9102
73959668|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.6391|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.6391
73839163|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0587|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0587
73839164|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin.||||1.0000
73839165|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin.||||0.1352
74083916|NCT04010227|147720977|SUPERIORITY||partial correlation|0.02||||0.94|TWO_SIDED|95.0|-0.3|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.34|-0.30|0.94
74083917|NCT01841073|147720978|SUPERIORITY|||||||0.005||||||p-value was calculated, and is not attempting to indicate the threshold for statistical significance|ANCOVA|||||||0.005
74083918|NCT01841073|147720979|SUPERIORITY|||||||0.027|||||||ANCOVA|||||||0.027
74083919|NCT01841073|147720980|SUPERIORITY|||||||0.13|||||||ANCOVA|||||||0.13
74083920|NCT03174158|147720981|SUPERIORITY|||||||0.07||||||a priori p value threshold \< 0.05|Chi-squared|||||||0.07
74083921|NCT03174158|147720981|SUPERIORITY|||||||0.18|||||||Chi-squared|a priori threshold p\<0.05||||||0.18
74083922|NCT03174158|147720981|SUPERIORITY|||||||0.21||||||a priori threshold p\<0.05|Chi-squared|||||||0.21
74083923|NCT00283842|147720990|SUPERIORITY_OR_OTHER|||||||0.084|||||||Hochberg|||Statistical analysis provided for 50mg.||||0.084
74083924|NCT00283842|147720990|SUPERIORITY_OR_OTHER|||||||0.084|||||||Hochberg|||Statistical analysis provided for 100mg.||||0.084
74083925|NCT00283842|147720990|SUPERIORITY_OR_OTHER|||||||0.001|||||||Hochberg|||Statistical analysis provided for 200mg.||||0.001
74083926|NCT00283842|147720990|SUPERIORITY_OR_OTHER|||||||0.027|||||||Hochberg|||Statistical analysis provided for 400mg.||||0.027
74083927|NCT00283842|147720991|SUPERIORITY_OR_OTHER|||||||0.375|||||||Hochberg|||Statistical analysis provided for 50mg.||||0.375
74083928|NCT00283842|147720991|SUPERIORITY_OR_OTHER|||||||0.342|||||||Hochberg|||Statistical analysis provided for 100mg.||||0.342
73898467|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|3.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74083929|NCT00283842|147720991|SUPERIORITY_OR_OTHER|||||||0.342|||||||Hochberg|||Statistical analysis provided for 200mg.||||0.342
74083930|NCT00283842|147720991|SUPERIORITY_OR_OTHER|||||||0.375|||||||Hochberg|||Statistical analysis provided for 400mg.||||0.375
74083931|NCT00702507|147721023|SUPERIORITY_OR_OTHER||Percentage of participants|29.2|||||TWO_SIDED|95.0|22.4|36.7|||||Percentage of participants with overall cure at the test-of-cure visit (Day 14) of the initial episode for participants in the MITT Population|||36.7|22.4|
74083932|NCT01277510|147721084|SUPERIORITY_OR_OTHER_LEGACY||Difference (Cinacalcet - Placebo)|35.5||||0.017|TWO_SIDED|95.0|8.76|62.24|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).||A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints (Outcome Measures 1-5). The primary endpoint was tested at a significance level of 0.05. The four biochemical secondary endpoints were to be tested using Holm's method at 0.05 should the primary endpoint achieve a significant result.||62.24|8.76|0.017
74083933|NCT01277510|147721085|SUPERIORITY_OR_OTHER_LEGACY||Difference (Cinacalcet - Placebo)|3.46||||0.826|TWO_SIDED|95.0|-22.58|29.51|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).||The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||29.51|-22.58|0.826
74083934|NCT01277510|147721086|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.7||||0.147|TWO_SIDED|95.0|-8.6|1.3|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||1.3|-8.6|0.147
74083935|NCT01277510|147721087|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.3||||0.454|TWO_SIDED|95.0|-19.4|8.9|||ANCOVA|Baseline age group was used as covariate|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||8.9|-19.4|0.454
74088229|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.9|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.32|-0.90|<.0001
73839166|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin.||||0.1352
73839167|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis.||||0.0002
73839168|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0000
73839169|NCT02732145|147227359|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0854|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0854
73839170|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839171|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839172|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73959669|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6838|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6838
73959670|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.9648|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9648
73839173|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839174|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Anterior Commissure among patients from different groups?||||||0.0199|||||||Chi-squared|||"Parameter: The incidence of erythema of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0199
73839175|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839176|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839177|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73959671|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.8961|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.8961
73839178|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of fissures of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839179|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of fissures of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839180|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839181|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
73839182|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the frequency of smoothness of Labia Minora among patients from different groups?||||||0.0024|||||||Chi-squared|||"Parameter: The frequency of smoothness of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0024
73839183|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Posterior Commissure among patients from different groups?||||||0.0205|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0205
73839184|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.0158|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis.||||0.0158
73959672|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.9534|ONE_SIDED|95.0|-0.41||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.41|0.9534
73959673|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.7726|ONE_SIDED|95.0|-0.45||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.45|0.7726
73839185|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.0001
73839186|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.028|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.0280
73839187|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
73863166|NCT01073930|147272412|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|6.6|||||ONE_SIDED|97.5|1.6|||||||Mid colon comparison|||1.6|
73839188|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
73839189|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
73839190|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
73839191|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
73839192|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin.||||0.0000
73839193|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin.||||0.0006
73839194|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0000
73959674|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.18||0.5665|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.5665
73959675|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.2684|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2684
73839195|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0.0003|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0003
73839196|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0000
73839197|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.3053|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis.||||0.3053
73839198|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.7758|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis.||||0.7758
73839199|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.6676|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.6676
73959676|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.19||0.6485|ONE_SIDED|95.0|-0.39||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.39|0.6485
73839200|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.4577|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis.||||0.4577
73839201|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.1681|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.1681
73839202|NCT02732145|147227360|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.8848|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.8848
73839203|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73839204|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
73839205|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839206|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839207|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839208|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening among the patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839209|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839210|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839211|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839212|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73898468|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|0.91|STANDARD_ERROR_OF_MEAN|0.571||0.11|TWO_SIDED|95.0|-0.209|2.036||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.036|-0.209|0.110
73959677|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.4821|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.4821
73959678|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.2557|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2557
73959679|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.9031|ONE_SIDED|95.0|-0.52||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.52|0.9031
73959680|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.8634|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.8634
73959681|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.6375|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6375
73959682|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.18||0.8775|ONE_SIDED|95.0|-0.51||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.51|0.8775
73959683|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.7191|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.7191
73959684|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.8677|ONE_SIDED|95.0|-0.44||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.44|0.8677
73959685|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.9838|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.9838
73959686|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.8106|ONE_SIDED|95.0|-0.28||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.28|0.8106
73898469|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|4.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898470|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.555||0.263|TWO_SIDED|95.0|-1.713|0.469||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.469|-1.713|0.263
73959687|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.775|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.7750
73959688|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.8082|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.8082
73959689|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.7678|ONE_SIDED|95.0|-0.31||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.31|0.7678
73959690|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.5373|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.5373
73959691|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.14||0.9548|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.9548
73959692|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.9743|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9743
73959693|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.8408|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.8408
73839213|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839214|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Hymenal Remnants among patients from different groups?||||||0.0001|||||||Chi-squared|||"Parameter: The incidence of erythema of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0001
73839215|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Bartholin's Gland Opening among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839216|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839217|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Clitoris among patients from different groups?||||||0.0023|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0023
73839218|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839219|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Urethral Meatus among patients from different groups?||||||0.0235|||||||Chi-squared|||"Parameter: The incidence of smoothness of Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0235
73839220|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Clitoris among patients from different groups?||||||0.0021|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0021
73839221|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839222|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Urethral Meatus among patients from different groups?||||||0.0038|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0038
73839223|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Vestibule among patients from different groups?||||||0.0019|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0019
73839224|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of punctuation of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
73839225|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of punctuation of the Vestibule among patients from different groups?||||||0.0198|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0198
73898471|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|4.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73839226|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of papillae of Hart's Line among patients from different groups?||||||0.0004|||||||Chi-squared|||"Parameter: The incidence of papillae of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0004
73839227|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of papillae of the Vestibule among patients from different groups?||||||0.0053|||||||Chi-squared|||"Parameter: The incidence of papillae of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0053
73839228|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis.||||0.0010
73839229|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.||||0.0010
73839230|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0000
73839231|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0208
73839232|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
73959694|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.14||0.9887|ONE_SIDED|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.55|0.9887
73959695|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.13||0.9918|ONE_SIDED|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.55|0.9918
73839233|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0208
73839234|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
73959696|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.9833|ONE_SIDED|95.0|-0.46||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.46|0.9833
73959697|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.9619|ONE_SIDED|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.50|0.9619
74083936|NCT01277510|147721088|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.0||||0.117|TWO_SIDED|95.0|-22.5|2.6|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||2.6|-22.5|0.117
73839235|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.004|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0040
73839236|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0012|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0012
73959698|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.9917|ONE_SIDED|95.0|-0.58||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.58|0.9917
73839237|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0000
73839238|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0048
73839239|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0007
73839240|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0048
73839241|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0007
73839242|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0131|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0131
73839243|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia?||||||0.0423|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0423
73839244|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0021|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0021
73839245|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin.||||0.0000
73839246|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin.||||0.0000
73839247|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0091|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0091
73959699|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.9376|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.9376
73959700|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.9084|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.9084
73959701|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.15||0.7906|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7906
73959702|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.8765|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.8765
73959703|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.14||0.8469|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.8469
73959704|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.9717|ONE_SIDED|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.50|0.9717
73959705|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.7591|ONE_SIDED|95.0|-0.29||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.29|0.7591
73959706|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.7141|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7141
73959707|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.8104|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.8104
73959708|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.15||0.7664|ONE_SIDED|95.0|-0.35||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.35|0.7664
73959709|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.7888|ONE_SIDED|95.0|-0.31||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.31|0.7888
73959710|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.393|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.3930
73959711|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.4785|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.4785
73959712|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.6756|ONE_SIDED|95.0|-0.34||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.34|0.6756
73959713|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.2627|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2627
73959714|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.2281|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2281
73959715|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.7656|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7656
73959716|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.16||0.2105|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2105
73959717|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.2221|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.2221
73959718|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.4396|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.4396
73959719|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.15||0.2243|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.2243
73839248|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.||||0.0002
73839249|NCT02732145|147227361|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.||||0.0000
73839250|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0013|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.||||0.0013
73839251|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.||||0.0001
73839252|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.||||0.0000
73839253|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.||||0.0008
73839254|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0251|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0251
73839255|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0006
73839256|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.0211|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis.||||0.0211
73839257|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.3067|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.||||0.3067
73839258|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis.||||0.0295
73839259|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0149|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0149
73839260|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
73839261|NCT02732145|147227361|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0295
73839262|NCT02732145|147227362|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening between patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening between patients from different groups, with positive AWR.||||0.0000
73839263|NCT02732145|147227362|EQUIVALENCE|Question: Is there a difference in the incidence of coarse AWR between patients from different groups and positive AWR?||||||0.0071|||||||Chi-squared|||Parameter: The difference in the incidence of coarse AWR between patients from different groups and positive AWR.||||0.0071
73839264|NCT02732145|147227362|EQUIVALENCE|Question: Is there a difference in the incidence of slow AWR between patients from different groups and positive AWR?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of slow AWR occurrence between patients from different groups and positive AWR.||||0.0010
73839265|NCT02732145|147227362|EQUIVALENCE|Question: Is there a difference in the incidence of provoked erythema among patients from different groups and positive AWR?||||||0.0036|||||||Chi-squared|||Parameter: The difference in the incidence of provoked erythema among patients from different groups and positive AWR.||||0.0036
74083937|NCT01277510|147721089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.896|TWO_SIDED|95.0|-3.1|3.6||No adjustments for multiplicity were made.|ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|||3.6|-3.1|0.896
73839266|NCT02732145|147227362|EQUIVALENCE|Question: Is there a difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR.||||0.0032
74083938|NCT01277510|147721091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8||||0.854|TWO_SIDED|95.0|-9.4|7.9|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|||7.9|-9.4|0.854
74083939|NCT01321177|147721102|SUPERIORITY|||||||0.0145|||||||Regression, Linear|||||||0.0145
74083940|NCT03980522|147721106|OTHER||Inter-subject variance|19.1908|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and standard deviation (SD) from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
74083941|NCT03980522|147721106|OTHER||Inter-subject variance|0.0018|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
73959720|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.3597|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.3597
73959721|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.14||0.203|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.2030
73959722|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.1207|ONE_SIDED|95.0|-0.07||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.07|0.1207
73959723|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.12||0.1836|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.1836
73959724|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.17||0.2359|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.2359
74022155|NCT01431287|147597081|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.078|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.127|0.078|<0.0001
74022156|NCT01431287|147597081|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.096|0.145||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.145|0.096|< 0.0001
74022157|NCT01431287|147597081|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.131|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.106|0.155||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.155|0.106|<0.0001
74022158|NCT01431287|147597081|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.091|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.066|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.115|0.066|<0.0001
74022159|NCT01431287|147597081|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3394|TWO_SIDED|95.0|-0.013|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.036|-0.013|0.3394
74022160|NCT01431287|147597081|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.143|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.118|0.167||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.167|0.118|<0.0001
74022161|NCT01431287|147597081|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.012||0.0173|TWO_SIDED|95.0|0.005|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|0.005|0.0173
74022162|NCT01431287|147597081|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.421|TWO_SIDED|95.0|-0.035|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.014|-0.035|0.4210
74022163|NCT01431287|147597081|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.012||0.0014|TWO_SIDED|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.064|0.015|0.0014
74022164|NCT01431287|147597082|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.063|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.063|<0.0001
74083942|NCT03980522|147721106|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
74022165|NCT01431287|147597082|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.024|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.075|0.024|0.0001
74022166|NCT01431287|147597082|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.042|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.092|0.042|<0.0001
74022167|NCT01431287|147597082|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.087|0.037|<0.0001
74022168|NCT01431287|147597082|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.0231|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|0.004|0.0231
74022169|NCT01431287|147597082|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.013||0.1073|TWO_SIDED|95.0|-0.004|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.046|-0.004|0.1073
74022170|NCT01431287|147597082|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.083|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.058|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.108|0.058|<0.0001
74022171|NCT01431287|147597082|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.013||0.0029|TWO_SIDED|95.0|0.013|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|0.013|0.0029
74022172|NCT01431287|147597082|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.013||0.6939|TWO_SIDED|95.0|-0.02|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.030|-0.020|0.6939
74022173|NCT01431287|147597082|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0097|TWO_SIDED|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.058|0.008|0.0097
74022174|NCT01431287|147597083|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.693|STANDARD_ERROR_OF_MEAN|0.553||0.0022|TWO_SIDED|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.608|-2.778|0.0022
74022175|NCT01431287|147597083|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.233|STANDARD_ERROR_OF_MEAN|0.551||0.0252|TWO_SIDED|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.153|-2.313|0.0252
74022176|NCT01431287|147597083|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.031|STANDARD_ERROR_OF_MEAN|0.552||0.062|TWO_SIDED|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.052|-2.113|0.0620
74022177|NCT01431287|147597083|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.456|STANDARD_ERROR_OF_MEAN|0.548||0.4051|TWO_SIDED|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.618|-1.531|0.4051
74022178|NCT01431287|147597083|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.571|STANDARD_ERROR_OF_MEAN|0.55||0.2988|TWO_SIDED|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.507|-1.649|0.2988
73839267|NCT02732145|147227362|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
73839268|NCT02732145|147227362|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
73839269|NCT02732145|147227362|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
73839270|NCT02732145|147227362|EQUIVALENCE|"Question: Is there a difference in the incidence of Ring sign between the patients from different groups and positive AWR?"||||||0|||||||Chi-squared|||"Parameter: The difference in the incidence of Ring sign, aceto-whitening of all structures of the Inner Vulvar Ring, between the patients from different groups and positive AWR."||||0.0000
73839271|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0856|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.0856
73839272|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.4290
73839273|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0124|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.0124
73839274|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR.||||0.0000
73839275|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.||||0.0000
73839276|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.||||0.1918
73839277|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.0000
73839278|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.0000
73839279|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0.5822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.5822
73839280|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR.||||0.0000
73839281|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR.||||0.0000
73839282|NCT02732145|147227362|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0.4975|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR.||||0.4975
73839283|NCT02732145|147227363|EQUIVALENCE|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients from different groups, in which the AWR was positive?||||||0.0003|||||||ANOVA|||Parameter: The difference in the velocity of the aceto-whitening occurrence (positive AWR) among patients from different groups, in which the AWR was positive.||||0.0003
73839284|NCT02732145|147227364|EQUIVALENCE|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups?||||||0.0004|||||||Kruskal-Wallis|||Parameter: The difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups.||||0.0004
73839285|NCT02732145|147227364|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR?||||||0.0231|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR.||||0.0231
73898472|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.57||0.868|TWO_SIDED|95.0|-1.026|1.217||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.217|-1.026|0.868
74022179|NCT01431287|147597083|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.662|STANDARD_ERROR_OF_MEAN|0.545||0.2249|TWO_SIDED|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.407|-1.731|0.2249
74022180|NCT01431287|147597083|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.118|STANDARD_ERROR_OF_MEAN|0.549||0.0418|TWO_SIDED|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.042|-2.195|0.0418
74022181|NCT01431287|147597083|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.557||0.4097|TWO_SIDED|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.633|-1.552|0.4097
74083943|NCT03980522|147721106|OTHER||Intra-subject variance|12.6852|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
74083944|NCT03980522|147721106|OTHER||Intra-subject variance|0.1842|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
74083945|NCT03980522|147721106|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
74083946|NCT03980522|147721107|OTHER||Inter-subject variance|34.1446|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083947|NCT03980522|147721107|OTHER||Inter-subject variance|0.1326|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083948|NCT03980522|147721107|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083949|NCT03980522|147721107|OTHER||Intra-subject variance|0.0548|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083950|NCT03980522|147721107|OTHER||Intra-subject variance|0.0134|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083951|NCT03980522|147721107|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083952|NCT03980522|147721108|OTHER||Inter-subject variance|2.8139|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
74083953|NCT03980522|147721108|OTHER||Inter-subject variance|6.9999|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
73839286|NCT02732145|147227364|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR?||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR.||||0.0006
73839287|NCT02732145|147227364|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR?||||||0|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR.||||0.0000
73839288|NCT02732145|147227365|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR.||||0.0000
73839289|NCT02732145|147227365|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR.||||0.0000
73839290|NCT02732145|147227365|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR.||||0.0000
73839291|NCT02732145|147227365|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR?||||||0.0128|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR.||||0.0128
73839292|NCT02732145|147227365|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR.||||0.0000
73839293|NCT02732145|147227365|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0.0635|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR.||||0.0635
73839294|NCT02732145|147227365|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR.||||0.0429
73839295|NCT02732145|147227365|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR?||||||0.0011|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR.||||0.0011
73839296|NCT02732145|147227365|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR?||||||0.0936|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR.||||0.0936
73839297|NCT02732145|147227365|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR.||||1.0000
73839298|NCT02732145|147227365|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR.||||0.0429
73839299|NCT02732145|147227365|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR.||||0.0429
73839300|NCT02732145|147227366|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR.||||0.0000
73839301|NCT02732145|147227366|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR.||||0.0000
73839302|NCT02732145|147227366|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR.||||0.0000
73839303|NCT02732145|147227366|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR.||||0.0000
73839304|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR.||||0.0318
73839305|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR.||||0.0318
73839306|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0000
73839307|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR.||||1.0000
73839308|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0389
73839309|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0389
73839310|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR?||||||1e-05|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR.||||0.00001
73839311|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR.||||0.0000
73839312|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
73839313|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR.||||0.0008
73839314|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
73839315|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
73839316|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR.||||0.0005
73839317|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR.||||0.0000
73839318|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
73839319|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0.4505|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR.||||0.4505
73839320|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
73839321|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
73839322|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR.||||1.0000
73839323|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR.||||0.0534
73839324|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0000
73839325|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR.||||0.0534
73839326|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0000
73839327|NCT02732145|147227366|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0005
73839328|NCT02732145|147227367|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR.||||0.0000
73839329|NCT02732145|147227367|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR.||||0.0000
73839330|NCT02732145|147227367|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR.||||0.0000
73839331|NCT02732145|147227367|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR.||||0.0000
73839332|NCT02732145|147227367|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR.||||0.0000
73839333|NCT02732145|147227367|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR.||||0.0000
73839334|NCT02732145|147227367|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR.||||0.0000
73839335|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR?||||||0.8545|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR.||||0.8545
73839336|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.8569|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.||||0.8569
73839337|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.2478
73839338|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.2478
73839339|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.||||0.1627
73839340|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.5943|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.5943
73839341|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.7161|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.||||0.7161
74022182|NCT01431287|147597083|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.575|STANDARD_ERROR_OF_MEAN|0.556||0.3013|TWO_SIDED|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.515|-1.664|0.3013
73839342|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.3301
73839343|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.3301
73839344|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.||||0.1627
74022183|NCT01431287|147597083|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.554||0.8355|TWO_SIDED|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||1.200|-0.970|0.8355
74022184|NCT01431287|147597084|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.135||0.0019|TWO_SIDED|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.684|0.155|0.0019
74022185|NCT01431287|147597084|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.356|STANDARD_ERROR_OF_MEAN|0.135||0.0082|TWO_SIDED|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.619|0.092|0.0082
74022186|NCT01431287|147597084|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.416|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.681|0.152|0.0020
74022187|NCT01431287|147597084|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.134||0.0307|TWO_SIDED|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.554|0.027|0.0307
74022188|NCT01431287|147597084|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.352|STANDARD_ERROR_OF_MEAN|0.135||0.0088|TWO_SIDED|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.616|0.089|0.0088
73839345|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.4742|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.4742
73839346|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.1822
73839347|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.1822
73839348|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.0927|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.0927
73839349|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.036|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.0360
73839350|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR.||||0.0720
73898473|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
74022189|NCT01431287|147597084|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.134||0.9801|TWO_SIDED|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.266|-0.259|0.9801
73839351|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR.||||1.0000
73839352|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.4833
73839353|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.3594
73839354|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.5987|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.||||0.5987
73839355|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR?||||||0.4164|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR.||||0.4164
73839356|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR.||||0.0720
73839357|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.0148|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.0148
73839358|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.0085|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.0085
73839359|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.||||0.1918
73839360|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR?||||||0.3037|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR.||||0.3037
73839361|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.4833
73839362|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.3594
73839363|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR?||||||0.0877|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR.||||0.0877
73839364|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR?||||||0.7726|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR.||||0.7726
73839365|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR?||||||0.0191|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR.||||0.0191
73839366|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.||||0.0287
73839367|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.6374|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.6374
73839368|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.7512|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.7512
73839369|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2734|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.||||0.2734
73839370|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.0287
73839371|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.||||0.8732
73839372|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0602|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.0602
73839373|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0079|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.0079
73839374|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2081|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.||||0.2081
73839375|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.8732
73839376|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0852|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.0852
73839377|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.0125
73839378|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.0125
73839379|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.2714|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.2714
73839380|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR.||||0.1692
73839381|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.0772|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR.||||0.0772
73839382|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.5762
73839383|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.5762
73839384|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.||||1.0000
73839385|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR.||||0.0078
74022190|NCT01431287|147597084|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.294|STANDARD_ERROR_OF_MEAN|0.134||0.0289|TWO_SIDED|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.557|0.030|0.0289
73839386|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.6862|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR.||||0.6862
73839387|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.0563
73839388|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.0563
73839389|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.||||0.1692
73839390|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR?||||||0.1822|||||||t|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR.||||0.1822
73839391|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.0220
73839392|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.0220
73839393|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR.||||0.0220
73839394|NCT02732145|147227367|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR.||||0.0078
73839395|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of hyperkeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperkeratosis in vulvar specimens of patients from different groups.||||0.0000
73839396|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of parakeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of parakeratosis in vulvar specimens of patients from different groups.||||0.0000
73839397|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of acanthosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of acanthosis in vulvar specimens of patients from different groups.||||0.0000
73839398|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of epidermal atrophy in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of epidermal atrophy in vulvar specimens of patients from different groups.||||0.0000
73839399|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens of patients from different groups.||||0.0000
73839400|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups.||||0.0000
73839401|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of lymphocytes in vulvar specimens of patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes (infiltrates) in vulvar specimens of patients from different groups.||||0.0105
73839402|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of mastocytes in vulvar specimens of patients from different groups?||||||0.0064|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mastocytes in vulvar specimens of patients from different groups.||||0.0064
73839403|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of collagen fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens of patients from different groups.||||0.0000
73839404|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of hyalinization in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens of patients from different groups.||||0.0000
73839405|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of hyperpigmentation in vulvar specimens of patients from different groups?||||||0.0342|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperpigmentation in vulvar specimens of patients from different groups.||||0.0342
73839406|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of elongated dermal papillae in vulvar specimens of patients from different groups?||||||0.0148|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of elongated dermal papillae in vulvar specimens of patients from different groups.||||0.0148
73839407|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of blood vessels in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens of patients from different groups.||||0.0000
73839408|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens of patients from different groups.||||0.0000
73839409|NCT02732145|147227368|EQUIVALENCE|Question: Is there a difference in the incidence of nerve fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens of patients from different groups.||||0.0000
73839410|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.0000
73839411|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||1|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||1.0000
73839412|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.3533|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.3533
73839413|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.5641|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.5641
73839414|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9684|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9684
73839415|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8599|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8599
73839416|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9402
73839417|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8389|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8389
73839418|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.7617|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.7617
73839419|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of the sharp pain of the vulva depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.4613|||||||Chi-squared|||Parameter: The difference in the incidence of the sharp (fast) pain of the vulva (knife-like pain, paper-cuts pain, stabbing, sticking) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.4613
73839420|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.0331|||||||Chi-squared, Corrected|||Parameter: The incidence of the vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.0331
73839421|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of the vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9402
73839422|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9139|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9139
74083954|NCT03980522|147721108|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
73839423|NCT02732145|147227369|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8925|||||||Chi-squared|||Parameter: The incidence of the vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8925
73839424|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0000
73839425|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the dull pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6921|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6921
74022191|NCT01431287|147597084|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.136||0.6382|TWO_SIDED|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.330|-0.202|0.6382
73839426|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of vulvar burning on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.1848|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.1848
73839427|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.9048|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.9048
73839428|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3953|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.3953
73839429|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0921|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0921
73839430|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6734|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6734
73839431|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3458|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.3458
73839432|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.5304|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.5304
73839433|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the sharp pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0012|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp (fast) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0012
73839434|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0002|||||||Chi-squared|||Parameter: The incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0002
73839435|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0218|||||||Chi-squared, Corrected|||Parameter: The incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0218
73839436|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0297|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0297
73839437|NCT02732145|147227370|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6468
73839438|NCT02732145|147227371|SUPERIORITY|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.2045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.2045
73898474|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.592||0.82|TWO_SIDED|95.0|-1.298|1.029||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.029|-1.298|0.820
73839439|NCT02732145|147227371|SUPERIORITY|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.7469|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.7469
73839440|NCT02732145|147227371|SUPERIORITY|Question: Is there a difference in the incidence of the finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.4271|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.4271
73839441|NCT02732145|147227371|SUPERIORITY|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.3607|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.3607
73839442|NCT02732145|147227371|SUPERIORITY|Question: Is there a difference in the incidence of the finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.8672
73839443|NCT02732145|147227372|SUPERIORITY|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0045
73839444|NCT02732145|147227372|SUPERIORITY|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0032
73839445|NCT02732145|147227372|SUPERIORITY|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.1067|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.1067
73839446|NCT02732145|147227372|SUPERIORITY|Question: Is there a difference in the incidence of inflammatory cells in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.8672
73839447|NCT02732145|147227372|SUPERIORITY|Question: Is there a difference in the incidence of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0219|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0219
73839448|NCT02732145|147227372|SUPERIORITY|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8213|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.8213
73839449|NCT02732145|147227372|SUPERIORITY|Question: Is there a difference in the incidence of the finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0613|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0613
73839450|NCT02965976|147227382|SUPERIORITY|||||||0.773|||||||Cochran-Mantel-Haenszel|||||||0.773
73839451|NCT02965976|147227383|SUPERIORITY|||||||0.773|||||||Cochran-Mantel-Haenszel|||||||0.773
73839452|NCT02965976|147227384|SUPERIORITY|||||||0.368|||||||t-test, 2 sided|||||||0.368
73839453|NCT02965976|147227385|SUPERIORITY|||||||0.987|||||||t-test, 2 sided|||||||0.987
73839454|NCT02965976|147227386|SUPERIORITY|||||||0.423|||||||Cochran-Mantel-Haenszel|||||||0.423
73839455|NCT02965976|147227387|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.000
73839456|NCT04191733|147227421|NON_INFERIORITY|The non-inferiority analysis was demonstrated when the 1-sided upper 95% confidence interval (CI) limit was less than 1.25.|||||<|0.0001||||||one-sided p-value|t-test, 1 sided|||||||<0.0001
73839457|NCT04191733|147227422|NON_INFERIORITY|1-sided test with 5% alpha was used to demonstrate non-inferiority with greater than 99% power. The non-inferiority margin was 3.75 minutes.||||||0.1004|||||||t-test, 1 sided|||A gatekeeping strategy was used to control family-wise type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The testing sequence continued only when previous endpoint was statistically significant with a 1-sided alpha of 0.05.||||0.1004
73839458|NCT02349477|147227441|SUPERIORITY||Odds Ratio (OR)|3.9||||0.028|TWO_SIDED||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for no heavy drinking days.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no heavy drinking days throughout the entire trial, corrected for %dCDT.||||.028
73898475|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|4.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73839459|NCT02349477|147227442|SUPERIORITY||Odds Ratio (OR)|4.9||||0.053|TWO_SIDED||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for abstinence.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no drinking days (abstinence) throughout the entire trial, corrected for %dCDT.||||.053
73839460|NCT02349477|147227443|SUPERIORITY|||||||0.001|||||||Chi-squared|||For the High AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.||||.001
73839461|NCT02349477|147227443|SUPERIORITY|||||||0.67|||||||Chi-squared|||For the Low AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.||||.67
73839462|NCT01714063|147227458|OTHER|We used a paired T-test for statistical analysis to compare the filter dose. Using the 1% significance level and assuming a between-subject standard deviation of 60 lg (27%) for the difference between coordinated and doses, 32 subjects are sufficient to detect a 45 lg (20%) difference with 95% confidence.uncoordinated filter|||||<|0.001|||||||paired t-test|||||||<0.001
73839463|NCT00318136|147227463|SUPERIORITY_OR_OTHER||Percentage of patients|3.2||||||90.0|0.3|13.5|||Blyth-Still-Casella|||||13.5|0.3|
73839464|NCT03769116|147227476|OTHER||Hodges-Lehmann treatment diff|6.11|||<|0.0001|TWO_SIDED|95.0|2.08|12.58|||Wilcoxon rank sum test|||Analysis conducted on changes from baseline.||12.58|2.08|< 0.0001
73839465|NCT03769116|147227477|OTHER||LSM Change Difference|0.8|STANDARD_ERROR_OF_MEAN|0.9|=|0.373|TWO_SIDED|95.0|-1.0|2.7|||Mixed-model for Repeated Measures|||||2.7|-1.0|= 0.3730
73839466|NCT03769116|147227485|OTHER||LSM Change Difference|2.5|STANDARD_ERROR_OF_MEAN|0.9|=|0.0172|TWO_SIDED|95.0|0.5|4.4|||Mixed-model for Repeated Measures|||Change from baseline - Age Group: 4-5 years old||4.4|0.5|= 0.0172
73839467|NCT03769116|147227485|OTHER||LSM Change Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.1|=|0.5384|TWO_SIDED|95.0|-3.0|1.6|||Mixed-model for Repeated Measures|||Change from baseline - Age Group: 6-7 years old||1.6|-3.0|= 0.5384
73839468|NCT01887600|147227488|SUPERIORITY||Odds Ratio (OR)|34.74|||<|0.001|TWO_SIDED|95.0|20.48|58.93|||Cochran-Mantel-Haenszel||Please note Odds Ratio and CI are shown in percentages.|The Cochran-Mantel-Haenszel (CMH) test was adjusted by region, history of of cardiovascular, cerebrovascular or thromboembolic (CV) disease, baseline Hb and baseline estimated glomerular filtration rate (eGFR). Superiority of roxadustat versus placebo was to be declared if the lower bound of the two-sided 95% confidence interval of the CMH odds ratio was higher than 1.||58.93|20.48|<0.001
73839469|NCT01887600|147227489|SUPERIORITY||Least squares mean difference|1.692|||<|0.001||95.0|1.52|1.86|||ANCOVA|||The Analysis of Covariance (ANCOVA) with Multiple Imputations (MI) model, adjusting for covariates was used for the analysis. The model included treatment as fixed factor, region and history of CV disease as class factors and baseline Hb, baseline eGFR as continuous covariates. Superiority of roxadustat versus placebo was considered successful if the lower bound of the two-sided 95% confidence interval of the difference between treatment arms (roxadustat minus placebo) was higher than 0.||1.86|1.52|<0.001
73839470|NCT01887600|147227490|SUPERIORITY||Least squares mean difference|1.599|||<|0.001|TWO_SIDED|95.0|1.41|1.78||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit interaction as continuous covariates.||1.78|1.41|<0.001
73839471|NCT01887600|147227491|SUPERIORITY|Superiority of roxadustat versus placebo was considered successful if the upper bound of the two-sided 95% confidence interval of the difference between treatment arms (roxadustat minus placebo) is below 0.|Least squares mean difference|-0.701|||<|0.001||95.0|-0.83|-0.57||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects during the period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb, baseline eGFR and baseline LDL as continuous variables.||-0.57|-0.83|<0.001
73839472|NCT01887600|147227492|SUPERIORITY||Hazard Ratio (HR)|0.238|||<|0.001|TWO_SIDED|95.0|0.17|0.33||Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority is declared if the upper bound of the 95% CI is below 1.0.||0.33|0.17|<0.001
73839473|NCT01887600|147227493|SUPERIORITY||Least squares mean difference|1.127|||=|0.093|TWO_SIDED|95.0|-0.19|2.44||LSM Difference p-value is for test of differences.Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects throughout the evaluation period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline SF-36 VT, baseline Hb and baseline eGFR as continuous variables.||2.44|-0.19|=0.093
73839474|NCT01887600|147227494|SUPERIORITY||Least squares mean difference|0.713|||=|0.27|TWO_SIDED|95.0|-0.56|1.98||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects throughout the evaluation period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline SF-36 PF, baseline Hb and baseline eGFR as continuous variables.||1.98|-0.56|=0.27
73898476|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.583||0.781|TWO_SIDED|95.0|-0.984|1.308||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.308|-0.984|0.781
73898477|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|4.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73839475|NCT01887600|147227495|NON_INFERIORITY|Non-inferiority can be concluded if the upper bound of the two-sided 95% CI of the difference between roxadustat and placebo (roxadustat minus placebo) is below 2 mmHg.|Least squares mean difference|0.842|||=|0.182|TWO_SIDED|95.0|-0.4|2.08||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Mixed Model of Repeated Measures was applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms with overall mean effects throughout the evaluation period (weeks 20 to 28). The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||2.08|-0.40|=0.182
73839476|NCT01887600|147227496|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the 95% CI is below 1.3 (hazard ratio).|Hazard Ratio (HR)|1.29|||=|0.334|TWO_SIDED|95.0|0.77|2.16|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||2.16|0.77|=0.334
73839477|NCT01887600|147227497|SUPERIORITY||Least squares mean difference|0.59|||=|0.316|TWO_SIDED|95.0|-0.57|1.75|||Mixed Models Analysis|||Annualized eGFR slope over time was estimated by a random slopes and intercepts model using all available eGFR values adjusted on baseline Hb, region, CV history at Baseline and the interaction terms.||1.75|-0.57|=0.316
73839478|NCT01887600|147227498|SUPERIORITY||Least squares mean difference|1.638|||<|0.001|TWO_SIDED|95.0|1.44|1.84||LSM Difference p-value is for test of differences|Mixed Models Analysis|||Average Level of Hb Over Weeks 28 to 36. A Mixed Model of Repeated Measures was applied using the visits over weeks 28 to 36. The results were based on the estimated difference between the two treatment arms by visit based on this MMRM model. The model included treatment arm, region, CV History, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.84|1.44|<0.001
73839479|NCT01887600|147227499|SUPERIORITY||Least squares mean difference|1.604|||<|0.001|TWO_SIDED|95.0|1.39|1.82||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Average Level of Hb Over Weeks 44 to 52. A Mixed Model of Repeated Measures was applied using the visits over weeks 44 to 52. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.82|1.39|<0.001
73839480|NCT01887600|147227500|SUPERIORITY||Least squares mean difference|1.492|||<|0.001|TWO_SIDED|95.0|1.14|1.85||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Average Level of Hb Over Weeks 96 to 104. A Mixed Model of Repeated Measures was applied using the visits over weeks 96 to 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.85|1.14|<0.001
73839481|NCT01887600|147227501|SUPERIORITY||Hazard Ratio (HR)|19.001|||<|0.001|TWO_SIDED|95.0|11.98|30.15|||Regression, Cox|||Time to Achieve the First Hb Response. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||30.15|11.98|<0.001
73839482|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|0.396|||<|0.001|TWO_SIDED|95.0|0.29|0.5||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 1. A Mixed Model of Repeated Measures was applied using the visits up to week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||0.50|0.29|<0.001
73839483|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|0.938|||<|0.001|TWO_SIDED|95.0|0.81|1.07||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 2. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.07|0.81|<0.001
73839484|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.471|||<|0.001|TWO_SIDED|95.0|1.3|1.64||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 4. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.64|1.30|<0.001
73839485|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.827|||<|0.001|TWO_SIDED|95.0|1.64|2.02||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 6. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.02|1.64|<0.001
73839486|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|2.058|||<|0.001|TWO_SIDED|95.0|1.87|2.25||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 8. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.25|1.87|<0.001
73839487|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.949|||<|0.001|TWO_SIDED|95.0|1.75|2.14||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 10. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.14|1.75|<0.001
73898478|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|0.08|STANDARD_ERROR_OF_MEAN|0.59||0.895|TWO_SIDED|95.0|-1.082|1.238||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.238|-1.082|0.895
74022192|NCT01431287|147597084|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.135||0.3525|TWO_SIDED|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.391|-0.140|0.3525
73839488|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.9|2.28||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 12. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.28|1.90|<0.001
73898479|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|4.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73839489|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|2.051|||<|0.001|TWO_SIDED|95.0|1.86|2.24||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 14. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.24|1.86|<0.001
73839490|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.987|||<|0.001|TWO_SIDED|95.0|1.79|2.19||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 16. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.19|1.79|<0.001
73839491|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.841|||<|0.001|TWO_SIDED|95.0|1.64|2.05||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 18. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.05|1.64|<0.001
73839492|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.824|||<|0.001|TWO_SIDED|95.0|1.61|2.04||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 20. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.04|1.61|<0.001
74022193|NCT01431287|147597084|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.062|STANDARD_ERROR_OF_MEAN|0.135||0.6457|TWO_SIDED|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.203|-0.327|0.6457
73839493|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.651|||<|0.001|TWO_SIDED|95.0|1.43|1.87||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 22. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.87|1.43|<0.001
73898480|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|0.63|STANDARD_ERROR_OF_MEAN|0.69||0.359|TWO_SIDED|95.0|-0.724|1.991||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.991|-0.724|0.359
73959725|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.2861|ONE_SIDED|95.0|-0.18||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.18|0.2861
73959726|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.15||0.2151|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2151
73959727|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.3545|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.3545
73959728|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.7102|ONE_SIDED|95.0|-0.35||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.35|0.7102
73959729|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.3883|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.3883
73959730|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.2228|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.2228
73959731|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.6342|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.6342
73959732|NCT00430300|147454779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.14||0.3141|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.3141
73959733|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.27||0.27|ONE_SIDED|95.0|-0.28||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.28|0.2700
73959734|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.26||0.1831|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.1831
73839494|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.447|||<|0.001|TWO_SIDED|95.0|1.23|1.67||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 24. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.67|1.23|<0.001
73839495|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.561|||<|0.001|TWO_SIDED|95.0|1.34|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 28. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.34|<0.001
73839496|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.587|||<|0.001|TWO_SIDED|95.0|1.37|1.81||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 32. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.37|<0.001
73839497|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.46|1.92||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb Change from BL to week 36. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.92|1.46|<0.001
73839498|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.645|||<|0.001|TWO_SIDED|95.0|1.41|1.88||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 40. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.88|1.41|<0.001
73839499|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.699|||<|0.001|TWO_SIDED|95.0|1.45|1.94||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 44. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.94|1.45|<0.001
73839500|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.446|||<|0.001|TWO_SIDED|95.0|1.2|1.69||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 48. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.69|1.20|<0.001
73839501|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.641|||<|0.001|TWO_SIDED|95.0|1.39|1.89||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 52. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.89|1.39|<0.001
73839502|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.37|1.91||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 56. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.91|1.37|<0.001
73839503|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.634|||<|0.001|TWO_SIDED|95.0|1.33|1.94||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 60. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.94|1.33|<0.001
73839504|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.404|||<|0.001|TWO_SIDED|95.0|1.08|1.73||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 64. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.73|1.08|<0.001
73839505|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.499|||<|0.001|TWO_SIDED|95.0|1.18|1.82||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 68. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.82|1.18|<0.001
73839506|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.438|||<|0.001|TWO_SIDED|95.0|1.1|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 72. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.10|<0.001
73839507|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.185|||<|0.001|TWO_SIDED|95.0|0.83|1.54||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 76. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.54|0.83|<0.001
73839508|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.443|||<|0.001|TWO_SIDED|95.0|1.11|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 80. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.11|<0.001
73839509|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.374|||<|0.001|TWO_SIDED|95.0|0.99|1.75||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 84. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.75|0.99|<0.001
73839510|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.171|||<|0.001|TWO_SIDED|95.0|0.79|1.55||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 88. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.55|0.79|<0.001
73839511|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.382|||<|0.001|TWO_SIDED|95.0|0.98|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 92. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|0.98|<0.001
73839512|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.563|||<|0.001|TWO_SIDED|95.0|1.15|1.97||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 96. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.97|1.15|<0.001
73839513|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.448|||<|0.001|TWO_SIDED|95.0|1.06|1.83||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 100. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.83|1.06|<0.001
73839514|NCT01887600|147227502|SUPERIORITY||Least squares mean difference|1.347|||<|0.001|TWO_SIDED|95.0|0.9|1.79||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 104. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.79|0.90|<0.001
73839515|NCT01887600|147227503|SUPERIORITY||Least squares mean difference|1.614|||<|0.001|TWO_SIDED|95.0|1.42|1.81||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Change from baseline to average Hb weeks 28-36. A Mixed Model of Repeated Measures was applied using the visits up to week 36. The results were based on the estimated difference between the two treatment arms overall mean effect during week 28 to 36 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.42|<0.001
73839516|NCT01887600|147227504|SUPERIORITY||Least squares mean difference|1.594|||<|0.001|TWO_SIDED|95.0|1.38|1.81||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Change from baseline to average Hb weeks 44-52. A Mixed Model of Repeated Measures was applied using the visits up to week 52. The results were based on the estimated difference between the two treatment arms overall mean effect during week 44 to 52 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.38|<0.001
74083955|NCT03980522|147721108|OTHER||Intra-subject variance|0.9693|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
73839517|NCT01887600|147227505|SUPERIORITY||Least squares mean difference|1.452|||<|0.001|TWO_SIDED|95.0|1.1|1.8||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Change from BL to average Hb weeks 96-104. A Mixed Model of Repeated Measures was applied using the visits up to week 104. The results were based on the estimated difference between the two treatment arms overall mean effect during week 96 to 104 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.80|1.10|<0.001
73839518|NCT01887600|147227509|SUPERIORITY||Hazard Ratio (HR)|0.945|||=|0.643|TWO_SIDED|95.0|0.74|1.2|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.20|0.74|=0.643
73839519|NCT01887600|147227511|SUPERIORITY||Hazard Ratio (HR)|0.139|||<|0.001|TWO_SIDED|95.0|0.08|0.23|||Regression, Cox|||Time to start rescue therapy within first 24 weeks. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.23|0.08|<0.001
73839520|NCT01887600|147227512|SUPERIORITY||Cox Proportional Hazard|0.343|||<|0.001|TWO_SIDED|95.0|0.21|0.55|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.55|0.21|<0.001
73839521|NCT01887600|147227513|SUPERIORITY||Least squares mean difference|-0.045|||=|0.128|TWO_SIDED|95.0|-0.1|0.01|||ANCOVA|||The Analysis of Covariance (ANCOVA) model was applied including treatment as fixed factor, region and history of CV disease as class factors and baseline Hb, baseline eGFR as continuous covariates.||0.01|-0.10|=0.128
73839522|NCT01887600|147227514|SUPERIORITY||Least squares mean difference|-10.429|||=|0.183|TWO_SIDED|95.0|-25.81|4.95|||ANCOVA|||The Analysis of Covariance (ANCOVA) model was applied included treatment arm, region, CV history as categorical variables and baseline Hb and baseline eGFR as continuous variables.||4.95|-25.81|=0.183
74022194|NCT01431287|147597085|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0095|TWO_SIDED|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.008|0.0095
73839523|NCT01887600|147227515|SUPERIORITY||Hazard Ratio (HR)|0.101|||<|0.001|TWO_SIDED|95.0|0.06|0.17|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.17|0.06|<0.001
73839524|NCT01887600|147227516|SUPERIORITY||Hazard Ratio (HR)|0.538|||=|0.045|TWO_SIDED|95.0|0.29|0.99|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.99|0.29|=0.045
73839525|NCT01887600|147227525|SUPERIORITY||Least squares mean difference|0.374|||=|0.475|TWO_SIDED|95.0|-0.65|1.4||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||The Mixed Model of Repeated Measures included treatment, visit (week 8, week 12 and week 28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline eGFR as continuous covariates.||1.40|-0.65|=0.475
73839526|NCT01887600|147227526|SUPERIORITY||Least squares mean difference|1.704|||=|0.047|TWO_SIDED|95.0|0.02|3.38||LSM difference p-value is for test of differences|Mixed Models Analysis|||A Mixed Model of Repeated Measures was applied using the visits up to week 28. The model includes treatment, visit (week 8, week 12 and week 28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, baseline eGFR as continuous covariates. Baseline FACT-An Ans is defined as the FACT-An Ans value on day 1.||3.38|0.02|=0.047
73839527|NCT01887600|147227527|SUPERIORITY||Least squares mean difference|2.086|||=|0.225|TWO_SIDED|95.0|-1.29|5.46|||Mixed Models Analysis|||A Mixed Model of Repeated Measures was applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms overall mean effect during week 12 to 28 period based on this MMRM model.The model includes treatment, visit (week8, week12 and week28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline FACT-An Total Score, baseline Hb, baseline eGFR as continuous covariates.||5.46|-1.29|=0.225
73839528|NCT01887600|147227538|SUPERIORITY||Hazard Ratio (HR)|0.995|||=|0.973|TWO_SIDED|95.0|0.75|1.32|||Regression, Cox|||Time to doubling of serum Creatinine. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.32|0.75|=0.973
73839529|NCT01887600|147227539|SUPERIORITY||Hazard Ratio (HR)|0.995|||=|0.972|TWO_SIDED|95.0|0.76|1.3|||Regression, Cox|||Time to CKD progression. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.30|0.76|=0.972
73839530|NCT01887600|147227540|SUPERIORITY||Hazard Ratio (HR)|0.905|||=|0.439|TWO_SIDED|95.0|0.7|1.16|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.16|0.70|=0.439
73839531|NCT03688139|147227541|SUPERIORITY||difference in slopes|0.23||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
73839532|NCT03688139|147227541|OTHER|This analysis tested whether the course of LPP was associated with the course of BADS over the 9-week treatment period in the Engage group.|Slope|0.03||||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||.14
73839533|NCT03688139|147227542|SUPERIORITY||difference in slopes|-0.06||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||.69
73839534|NCT03688139|147227543|SUPERIORITY||difference in slopes|-0.03||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||.69
74083956|NCT03980522|147721108|OTHER||Intra-subject variance|0.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
74083957|NCT03980522|147721108|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
73839535|NCT03688139|147227544|SUPERIORITY||difference in slopes|-0.45||||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||.39
73839536|NCT03688139|147227545|OTHER|This analysis tested the hypothesis that change in LPP for each assessment interval would predict severity of anhedonia at the next assessment in Engage but not in Supportive Therapy.|difference in slopes|-0.1||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||.58
73839537|NCT03688139|147227545|OTHER|This analysis tested the hypothesis that change in SHAPS for each assessment interval would predict severity of anhedonia at the next assessment in Engage but not in Supportive Therapy.|difference in slopes|0.0||||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||.96
73839538|NCT00420056|147227546|SUPERIORITY_OR_OTHER|||||||0.4854|TWO_SIDED||||||Regression, Linear|||||||0.4854
73839539|NCT00420056|147227547|SUPERIORITY_OR_OTHER|||||||0.709|TWO_SIDED||||||Regression, Linear|||||||0.7090
73839540|NCT00420056|147227550|SUPERIORITY_OR_OTHER||Kappa|0.0638|||||TWO_SIDED|95.0|-0.0449|0.1726||||||FLT-PET response versus Objective response||0.1726|-0.0449|
73839541|NCT00420056|147227550|SUPERIORITY_OR_OTHER||Kappa|0.1864|||||TWO_SIDED|95.0|-0.2316|0.6045||||||FDG-PET response versus Objective response||0.6045|-0.2316|
73839542|NCT00420056|147227564|SUPERIORITY_OR_OTHER|||||||0.5954|TWO_SIDED||||||Regression, Linear|||Concentration versus Ki-67||||0.5954
73839543|NCT00420056|147227564|SUPERIORITY_OR_OTHER|||||||0.1286|TWO_SIDED||||||Regression, Linear|||Concentration versus Cyclin D1||||0.1286
73839544|NCT00420056|147227564|SUPERIORITY_OR_OTHER|||||||0.0956|TWO_SIDED||||||Regression, Linear|||Concentration versus phospho-Rb||||0.0956
73839545|NCT00420056|147227564|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Regression, Linear|||Concentration versus FLT-PET SUVmax||||0.2800
73839546|NCT00420056|147227564|SUPERIORITY_OR_OTHER|||||||0.4921|TWO_SIDED||||||Regression, Linear|||Concentration versus FDG-PET SUVmax||||0.4921
73839547|NCT00655356|147227581|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||<.00001
73839548|NCT00655356|147227582|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||.0075
73839549|NCT01694771|147227587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.144|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.144|0.090|<0.0001
73839550|NCT01694771|147227588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.088|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).||0.088|0.037|<0.0001
73839551|NCT01694771|147227589|SUPERIORITY_OR_OTHER||Mean change from baseline|0.119|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.147|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.147|0.090|<0.0001
73839552|NCT01694771|147227590|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.146|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.192|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.192|0.100|<0.0001
73839553|NCT01694771|147227591|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.063|STANDARD_ERROR_OF_MEAN|0.022||0.0047|TWO_SIDED|95.0|0.019|0.106|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).||0.106|0.019|0.0047
73839554|NCT01694771|147227592|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.106|0.201|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.201|0.106|<0.0001
73839555|NCT01694771|147227593|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|8.459|STANDARD_ERROR_OF_MEAN|2.192||0.0001|TWO_SIDED|95.0|4.159|12.759|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||12.759|4.159|0.0001
73839556|NCT01694771|147227594|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.478|STANDARD_ERROR_OF_MEAN|0.116|<|0.0001|TWO_SIDED|95.0|-0.706|-0.25|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.250|-0.706|<.0001
73839557|NCT01694771|147227595|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.083|STANDARD_ERROR_OF_MEAN|0.041||0.0442|TWO_SIDED|95.0|-0.164|-0.002|||ANCOVA|||"Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.002|-0.164|0.0442
73839558|NCT01694771|147227596|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.393|STANDARD_ERROR_OF_MEAN|0.098|<|0.0001|TWO_SIDED|95.0|-0.586|-0.2|||ANCOVA|||"Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.200|-0.586|<.0001
73839559|NCT00289900|147227597|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-13.2|||<|0.001|TWO_SIDED|95.0|-16.8|-9.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-9.6|-16.8|<0.001
73839560|NCT00289900|147227597|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.8|||<|0.001|TWO_SIDED|95.0|-13.8|-7.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-7.8|-13.8|<0.001
73839561|NCT00289900|147227597|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.1|||<|0.001|TWO_SIDED|95.0|-8.1|-2.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.1|-8.1|<0.001
73839562|NCT00289900|147227597|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.2||||0.007|TWO_SIDED|95.0|-7.2|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-1.2|-7.2|0.007
73839563|NCT00289900|147227598|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|19.9|||<|0.001|TWO_SIDED|95.0|17.2|22.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||22.6|17.2|<0.001
73839564|NCT00289900|147227598|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|21.3|||<|0.001|TWO_SIDED|95.0|19.0|23.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||23.6|19.0|<0.001
73839565|NCT00289900|147227598|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|22.1|||<|0.001|TWO_SIDED|95.0|19.8|24.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||24.4|19.8|<0.001
73839566|NCT00289900|147227598|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|23.0|||<|0.001|TWO_SIDED|95.0|20.7|25.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||25.3|20.7|<0.001
73839567|NCT00289900|147227599|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-17.3|||<|0.001|TWO_SIDED|95.0|-21.2|-13.3|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon's rank sum test|||-13.3|-21.2|<0.001
73839568|NCT00289900|147227599|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-19.1|-11.9|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-11.9|-19.1|<0.001
73839569|NCT00289900|147227599|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-13.7|-7.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-7.0|-13.7|<0.001
73839570|NCT00289900|147227599|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.8|||<|0.001|TWO_SIDED|95.0|-10.2|-3.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-3.4|-10.2|<0.001
73839571|NCT00289900|147227600|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.1|||<|0.001|TWO_SIDED|95.0|-12.1|-6.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-6.0|-12.1|<0.001
73839572|NCT00289900|147227600|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.4|||<|0.001|TWO_SIDED|95.0|-8.0|-2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.9|-8.0|<0.001
73839573|NCT00289900|147227600|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.4||||0.771|TWO_SIDED|95.0|-2.2|2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||2.9|-2.2|0.771
73839574|NCT00289900|147227600|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|2.4||||0.065|TWO_SIDED|95.0|-0.2|5.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||5.0|-0.2|0.065
73839575|NCT00289900|147227601|SUPERIORITY_OR_OTHER||Difference in least Squares Mean|-6.8|||<|0.001|TWO_SIDED|95.0|-10.2|-3.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-3.5|-10.2|<0.001
73839576|NCT00289900|147227601|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.0||||0.037|TWO_SIDED|95.0|-5.8|-0.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-0.2|-5.8|0.037
73839577|NCT00289900|147227601|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|2.8||||0.047|TWO_SIDED|95.0|0.0|5.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||5.6|0.0|0.047
73839578|NCT00289900|147227601|SUPERIORITY_OR_OTHER||Difference in Least Sqaures Mean|4.7|||<|0.001|TWO_SIDED|95.0|2.0|7.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||7.5|2.0|<0.001
73839579|NCT00289900|147227602|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.2|||<|0.001|TWO_SIDED|95.0|-12.1|-6.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-6.3|-12.1|<0.001
73839580|NCT00289900|147227602|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.2|||<|0.001|TWO_SIDED|95.0|-7.7|-2.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.8|-7.7|<0.001
73839581|NCT00289900|147227602|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.9||||0.476|TWO_SIDED|95.0|-3.3|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||1.5|-3.3|0.476
73959735|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.23||0.1796|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.1796
73839582|NCT00289900|147227602|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.2||||0.845|TWO_SIDED|95.0|-2.2|2.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||2.7|-2.2|0.845
73839583|NCT00289900|147227603|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|9.0|||<|0.001|TWO_SIDED|95.0|6.6|11.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||11.4|6.6|<0.001
73839584|NCT00289900|147227603|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|7.7|||<|0.001|TWO_SIDED|95.0|5.8|9.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||9.7|5.8|<0.001
73839585|NCT00289900|147227603|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|9.0|||<|0.001|TWO_SIDED|95.0|7.0|10.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||10.9|7.0|<0.001
73839586|NCT00289900|147227603|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|10.7|||<|0.001|TWO_SIDED|95.0|8.7|12.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||12.7|8.7|<0.001
73839587|NCT00289900|147227604|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.6||||0.003|TWO_SIDED|95.0|-6.0|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-1.2|-6.0|0.003
73839588|NCT00289900|147227604|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.5||||0.595|TWO_SIDED|95.0|-2.5|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||1.5|-2.5|0.595
73839589|NCT00289900|147227604|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|4.2|||<|0.001|TWO_SIDED|95.0|2.2|6.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||6.2|2.2|<0.001
73839590|NCT00289900|147227604|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|6.1|||<|0.001|TWO_SIDED|95.0|4.1|8.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||8.1|4.1|<0.001
73839591|NCT00289900|147227605|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-18.8|||<|0.001|TWO_SIDED|95.0|-24.2|-14.2|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-14.2|-24.2|<0.001
73839592|NCT00289900|147227605|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-20.5|||<|0.001|TWO_SIDED|95.0|-25.0|-16.6|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-16.6|-25.0|<0.001
73839593|NCT00289900|147227605|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.9|||<|0.001|TWO_SIDED|95.0|-27.8|-19.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-19.4|-27.8|<0.001
73839594|NCT00289900|147227605|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-24.6|||<|0.001|TWO_SIDED|95.0|-28.6|-20.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-20.0|-28.6|<0.001
73839595|NCT00289900|147227606|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8||||0.5|TWO_SIDED|95.0|-9.6|7.5|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||7.5|-9.6|0.500
73839596|NCT00289900|147227606|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.9||||0.083|TWO_SIDED|95.0|0.0|13.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||13.8|0.0|0.083
73839597|NCT00289900|147227606|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.9||||0.005|TWO_SIDED|95.0|5.2|18.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||18.8|5.2|0.005
73839598|NCT00289900|147227606|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.4|||<|0.001|TWO_SIDED|95.0|9.8|22.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||22.8|9.8|<0.001
73839599|NCT00289900|147227607|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.8|||<|0.001|TWO_SIDED|95.0|-15.6|-9.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-9.9|-15.6|<0.001
73839600|NCT00289900|147227607|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.8|||<|0.001|TWO_SIDED|95.0|-13.2|-8.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-8.4|-13.2|<0.001
73959736|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.8136|ONE_SIDED|95.0|-0.79||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.79|0.8136
73959737|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6877|ONE_SIDED|95.0|-0.66||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.66|0.6877
73839601|NCT00289900|147227607|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.4||||0.001|TWO_SIDED|95.0|-8.8|-4.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-4.0|-8.8|0.001
73839602|NCT00289900|147227607|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.6|||<|0.001|TWO_SIDED|95.0|-8.0|-3.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-3.2|-8.0|<0.001
73839603|NCT00289900|147227608|SUPERIORITY_OR_OTHER||Difference in Proportion|-1.4||||0.008|TWO_SIDED|95.0|-2.3|-0.5|||Miettinen and Nurminen|||||-0.5|-2.3|0.008
73839604|NCT00289900|147227609|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.7||||0.042|TWO_SIDED|95.0|-1.4|0.0|||Miettinen and Nurminen|||||-0.0|-1.4|0.042
73839605|NCT00289900|147227610|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.1||||0.346|TWO_SIDED|95.0|-0.5|0.4|||Miettinen and Nurminen|||||0.4|-0.5|0.346
73839606|NCT00289900|147227611|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.556|TWO_SIDED|95.0|-0.2|0.7|||Miettinen and Nurminen|||||0.7|-0.2|0.556
73839607|NCT00289900|147227612|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.134|TWO_SIDED|95.0|-0.1|0.8|||Miettinen and Nurminen|||||0.8|-0.1|0.134
73839608|NCT00289900|147227613|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.134||95.0|-0.1|0.8|||Miettinen and Nurminen|||||0.8|-0.1|0.134
73839609|NCT00289900|147227614|SUPERIORITY_OR_OTHER||Difference in Percentage|0.1||||0.5625|TWO_SIDED|95.0|-0.3|0.9|||Miettinen and Nurminen|||||0.9|-0.3|0.5625
73839610|NCT00289900|147227615|SUPERIORITY_OR_OTHER||Difference in Percentage|0.7||||0.0233|TWO_SIDED|95.0|0.1|1.7|||Miettinen and Nurminen|||||1.7|0.1|0.0233
73839611|NCT00289900|147227616|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1||||0.7858|TWO_SIDED|95.0|-0.4|0.6|||Miettinen and Nurminen|||||0.6|-0.4|0.7858
73839612|NCT00289900|147227617|SUPERIORITY_OR_OTHER||Difference in Percentage|13.7|||||TWO_SIDED|95.0|9.4|18.0|||Miettinen and Nurminen|||||18.0|9.4|
73839613|NCT00289900|147227618|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.7|||||TWO_SIDED|95.0|-2.6|1.4|||Miettinen and Nurminen|||||1.4|-2.6|
73839614|NCT00289900|147227619|SUPERIORITY_OR_OTHER||Difference in Percentage|11.7|||||TWO_SIDED|95.0|8.9|14.7|||Miettinen and Nurminen|||||14.7|8.9|
73839615|NCT00289900|147227620|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1|||||TWO_SIDED|95.0|-0.8|0.9|||Miettinen and Nurminen|||||0.9|-0.8|
73839616|NCT00289900|147227621|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1||||0.4997|TWO_SIDED|95.0|-0.4|0.5|||Miettinen and Nurminen|||||0.5|-0.4|0.4997
73839617|NCT05486065|147227630|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.82||||0.0002|TWO_SIDED|95.0|-1.25|-0.39|||ANCOVA|||||-0.39|-1.25|0.0002
73839618|NCT05486065|147227630|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.77||||0.0003|TWO_SIDED|95.0|-1.19|-0.35|||ANCOVA|||||-0.35|-1.19|0.0003
73839619|NCT05486065|147227630|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.64|||ANCOVA|||||-0.64|-1.50|<.0001
73959738|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.27||0.6382|ONE_SIDED|95.0|-0.54||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.54|0.6382
73839620|NCT05486065|147227630|OTHER||Treatment difference|0.05||||0.8305|TWO_SIDED|95.0|-0.38|0.47|||ANCOVA|||The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.||0.47|-0.38|0.8305
73839621|NCT05486065|147227630|OTHER|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.3||||0.1678|TWO_SIDED|95.0|-0.72|0.13|||ANCOVA|||||0.13|-0.72|0.1678
73839622|NCT05486065|147227630|OTHER|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.25||||0.2445|TWO_SIDED|95.0|-0.67|0.17|||ANCOVA|||||0.17|-0.67|0.2445
73839623|NCT02037984|147227690|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.81|||||TWO_SIDED|95.0|0.6|1.1||||||||1.10|0.60|
73839624|NCT02037984|147227690|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.22|||||TWO_SIDED|95.0|1.64|3.02||||||||3.02|1.64|
73839625|NCT02037984|147227690|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.37|||||TWO_SIDED|95.0|1.01|1.84||||||||1.84|1.01|
73839626|NCT02037984|147227690|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.71|||||TWO_SIDED|95.0|0.48|1.05||||||||1.05|0.48|
73839627|NCT02037984|147227690|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.6|||||TWO_SIDED|95.0|0.32|1.13||||||||1.13|0.32|
73839628|NCT02037984|147227690|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.34|||||TWO_SIDED|95.0|0.16|0.73||||||||0.73|0.16|
73839629|NCT02037984|147227690|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.72|||||TWO_SIDED|95.0|0.51|1.02||||||||1.02|0.51|
73839630|NCT02037984|147227690|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.74|||||TWO_SIDED|95.0|0.51|1.08||||||||1.08|0.51|
73839631|NCT02037984|147227690|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.59|||||TWO_SIDED|95.0|0.39|0.9||||||||0.90|0.39|
73839632|NCT02037984|147227690|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.92|||||TWO_SIDED|95.0|0.64|1.31||||||||1.31|0.64|
73839633|NCT02037984|147227690|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.88|||||TWO_SIDED|95.0|0.61|1.27||||||||1.27|0.61|
73839634|NCT02037984|147227690|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.22|||||TWO_SIDED|95.0|0.83|1.78||||||||1.78|0.83|
73839635|NCT02037984|147227690|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.91|||||TWO_SIDED|95.0|0.57|1.45||||||||1.45|0.57|
74083958|NCT03980522|147721109|OTHER||Inter-subject variance|1.9968|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083959|NCT03980522|147721109|OTHER||Inter-subject variance|0.9047|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083960|NCT03980522|147721109|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083961|NCT03980522|147721109|OTHER||Intra-subject variance|1.7598|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083962|NCT03980522|147721109|OTHER||Intra-subject variance|2.849|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083963|NCT03980522|147721109|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
74083964|NCT04892147|147721112|OTHER|"Mean value of Enjoyment (8-item summed scale) tested against the value of a Neutral Likert response (Neutral value = 3)."|||||<|0.001||||||The threshold for statistical significance was p = 0.05. The reported value is a calculated -p-value.|t-test, 2 sided|||||||<0.001
74083965|NCT04892147|147721113|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.259||||||The threshold for statistical significance was p = 0.05|Regression, Linear|||||||0.259
74083966|NCT04892147|147721114|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.711||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.711
74083967|NCT04892147|147721115|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.214||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.214
74083968|NCT04892147|147721116|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.317||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.317
74083969|NCT04892147|147721117|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.056||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.056
74083970|NCT04892147|147721118|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.562||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.562
74083971|NCT03538262|147721129|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.006
74083972|NCT03538262|147721129|OTHER|Statistical analysis for BL to Month 24|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74083973|NCT03538262|147721130|OTHER|||||||0.011|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.011
74083974|NCT03538262|147721130|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
74083975|NCT03538262|147721131|OTHER|||||||0.007|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.007
74083976|NCT03538262|147721131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
74083977|NCT03538262|147721131|OTHER|||||||0.004|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.004
74083978|NCT03538262|147721131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
74083979|NCT03538262|147721131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
74083980|NCT03538262|147721131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
74083981|NCT03538262|147721131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
74083982|NCT03538262|147721131|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
74083983|NCT03538262|147721132|OTHER|||||||0.996|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.996
74083984|NCT03538262|147721132|OTHER|||||||0.054|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.054
74083985|NCT03538262|147721132|OTHER|||||||0.025|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.025
74083986|NCT03538262|147721132|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.006
74083987|NCT03538262|147721133|OTHER|||||||0.145|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.145
74083988|NCT03538262|147721133|OTHER|||||||0.029|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.029
73839636|NCT02037984|147227690|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|67.5|||||TWO_SIDED|95.0|45.58|99.97||||||||99.97|45.58|
73839637|NCT02037984|147227690|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|23.9|||||TWO_SIDED|95.0|13.21|43.24||||||||43.24|13.21|
73839638|NCT02037984|147227691|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.52|||||TWO_SIDED|95.0|0.39|0.7||||||||0.70|0.39|
73839639|NCT02037984|147227691|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|1.79|||||TWO_SIDED|95.0|1.33|2.41||||||||2.41|1.33|
73839640|NCT02037984|147227691|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.87|||||TWO_SIDED|95.0|0.65|1.16||||||||1.16|0.65|
73839641|NCT02037984|147227691|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||TWO_SIDED|95.0|0.35|0.74||||||||0.74|0.35|
73839642|NCT02037984|147227691|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.31|||||TWO_SIDED|95.0|0.17|0.58||||||||0.58|0.17|
73839643|NCT02037984|147227691|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.16|||||TWO_SIDED|95.0|0.08|0.34||||||||0.34|0.08|
73839644|NCT02037984|147227691|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.48|||||TWO_SIDED|95.0|0.34|0.67||||||||0.67|0.34|
73839645|NCT02037984|147227691|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.56|||||TWO_SIDED|95.0|0.39|0.82||||||||0.82|0.39|
73839646|NCT02037984|147227691|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.64|||||TWO_SIDED|95.0|0.42|0.97||||||||0.97|0.42|
73839647|NCT02037984|147227691|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.85|||||TWO_SIDED|95.0|0.6|1.21||||||||1.21|0.60|
73839648|NCT02037984|147227691|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.66|||||TWO_SIDED|95.0|0.46|0.95||||||||0.95|0.46|
73839649|NCT02037984|147227691|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.11|||||TWO_SIDED|95.0|0.77|1.6||||||||1.60|0.77|
73839650|NCT02037984|147227691|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.68|||||TWO_SIDED|95.0|0.43|1.07||||||||1.07|0.43|
73839651|NCT02037984|147227691|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|44.61|||||TWO_SIDED|95.0|30.42|65.43||||||||65.43|30.42|
73839652|NCT02037984|147227691|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.29|||||TWO_SIDED|95.0|8.58|27.26||||||||27.26|8.58|
73839653|NCT02037984|147227692|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.78|||||TWO_SIDED|95.0|0.57|1.07||||||||1.07|0.57|
73839654|NCT02037984|147227692|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.68|||||TWO_SIDED|95.0|1.95|3.68||||||||3.68|1.95|
73839655|NCT02037984|147227692|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.52|||||TWO_SIDED|95.0|1.11|2.07||||||||2.07|1.11|
73839656|NCT02037984|147227692|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.68|||||TWO_SIDED|95.0|0.46|1.02||||||||1.02|0.46|
73839657|NCT02037984|147227692|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.33|||||TWO_SIDED|95.0|0.17|0.64||||||||0.64|0.17|
73839658|NCT02037984|147227692|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.11|||||TWO_SIDED|95.0|0.05|0.23||||||||0.23|0.05|
73839659|NCT02037984|147227692|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.73|||||TWO_SIDED|95.0|0.51|1.04||||||||1.04|0.51|
73839660|NCT02037984|147227692|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.88|||||TWO_SIDED|95.0|0.59|1.3||||||||1.30|0.59|
73839661|NCT02037984|147227692|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|1.03|||||TWO_SIDED|95.0|0.66|1.6||||||||1.60|0.66|
73839662|NCT02037984|147227692|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.96|||||TWO_SIDED|95.0|0.66|1.39||||||||1.39|0.66|
73839663|NCT02037984|147227692|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.64|1.39||||||||1.39|0.64|
73839664|NCT02037984|147227692|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.24|||||TWO_SIDED|95.0|0.84|1.84||||||||1.84|0.84|
73839665|NCT02037984|147227692|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.75|||||TWO_SIDED|95.0|0.46|1.23||||||||1.23|0.46|
73839666|NCT02037984|147227692|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|77.57|||||TWO_SIDED|95.0|51.6|116.6||||||||116.60|51.60|
73839667|NCT02037984|147227692|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.66|||||TWO_SIDED|95.0|8.46|28.98||||||||28.98|8.46|
73839668|NCT02037984|147227693|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.68|||||TWO_SIDED|95.0|0.5|0.93||||||||0.93|0.50|
73839669|NCT02037984|147227693|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.21|||||TWO_SIDED|95.0|1.62|3.02||||||||3.02|1.62|
73839670|NCT02037984|147227693|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.97|||||TWO_SIDED|95.0|0.71|1.31||||||||1.31|0.71|
73839671|NCT02037984|147227693|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.53|||||TWO_SIDED|95.0|0.36|0.79||||||||0.79|0.36|
73839672|NCT02037984|147227693|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.49|||||TWO_SIDED|95.0|0.26|0.94||||||||0.94|0.26|
73839673|NCT02037984|147227693|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.36|||||TWO_SIDED|95.0|0.17|0.77||||||||0.77|0.17|
73839674|NCT02037984|147227693|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.6|||||TWO_SIDED|95.0|0.42|0.85||||||||0.85|0.42|
73839675|NCT02037984|147227693|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.79|||||TWO_SIDED|95.0|0.54|1.16||||||||1.16|0.54|
73839676|NCT02037984|147227693|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.74|||||TWO_SIDED|95.0|0.48|1.14||||||||1.14|0.48|
73839677|NCT02037984|147227693|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.66|||||TWO_SIDED|95.0|0.46|0.95||||||||0.95|0.46|
73839678|NCT02037984|147227693|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.7|||||TWO_SIDED|95.0|0.48|1.02||||||||1.02|0.48|
73839679|NCT02037984|147227693|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.88|||||TWO_SIDED|95.0|0.6|1.29||||||||1.29|0.60|
73839680|NCT02037984|147227693|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.69|||||TWO_SIDED|95.0|0.43|1.12||||||||1.12|0.43|
73839681|NCT02037984|147227693|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|56.08|||||TWO_SIDED|95.0|37.66|83.52||||||||83.52|37.66|
73839682|NCT02037984|147227693|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|25.75|||||TWO_SIDED|95.0|14.18|46.78||||||||46.78|14.18|
73839683|NCT02037984|147227694|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.8|||||TWO_SIDED|95.0|0.58|1.09||||||||1.09|0.58|
73839684|NCT02037984|147227694|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.55|||||TWO_SIDED|95.0|1.86|3.49||||||||3.49|1.86|
73839685|NCT02037984|147227694|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.07|||||TWO_SIDED|95.0|0.79|1.46||||||||1.46|0.79|
73839686|NCT02037984|147227694|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||TWO_SIDED|95.0|0.34|0.76||||||||0.76|0.34|
73839687|NCT02037984|147227694|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.34|||||TWO_SIDED|95.0|0.17|0.65||||||||0.65|0.17|
73839688|NCT02037984|147227694|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.18|||||TWO_SIDED|95.0|0.08|0.38||||||||0.38|0.08|
73839689|NCT02037984|147227694|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.59|||||TWO_SIDED|95.0|0.41|0.84||||||||0.84|0.41|
73839690|NCT02037984|147227694|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.68|||||TWO_SIDED|95.0|0.46|1.01||||||||1.01|0.46|
73839691|NCT02037984|147227694|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.79|||||TWO_SIDED|95.0|0.51|1.22||||||||1.22|0.51|
73839692|NCT02037984|147227694|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.72|||||TWO_SIDED|95.0|0.5|1.05||||||||1.05|0.50|
73839693|NCT02037984|147227694|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.55|||||TWO_SIDED|95.0|0.37|0.8||||||||0.80|0.37|
73839694|NCT02037984|147227694|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.97|||||TWO_SIDED|95.0|0.66|1.44||||||||1.44|0.66|
73839695|NCT02037984|147227694|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.79|||||TWO_SIDED|95.0|0.49|1.28||||||||1.28|0.49|
73839696|NCT02037984|147227694|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|68.64|||||TWO_SIDED|95.0|45.81|102.84||||||||102.84|45.81|
73839697|NCT02037984|147227694|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|20.03|||||TWO_SIDED|95.0|10.88|36.88||||||||36.88|10.88|
73839698|NCT02037984|147227698|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.2|||||TWO_SIDED|95.0|-16.3|6.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.5|-16.3|
73839699|NCT02037984|147227698|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.6|||||TWO_SIDED|95.0|-4.1|32.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||32.5|-4.1|
73839700|NCT02037984|147227698|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.0|||||TWO_SIDED|95.0|-22.8|5.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.7|-22.8|
73839701|NCT02037984|147227698|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
73839702|NCT02037984|147227698|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
73839703|NCT02037984|147227698|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
73839704|NCT02037984|147227698|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
73839705|NCT02037984|147227698|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
73839706|NCT02037984|147227698|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
73839707|NCT02037984|147227698|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
73839708|NCT02037984|147227698|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
73839709|NCT02037984|147227698|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
73839710|NCT02037984|147227698|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
73839711|NCT02037984|147227698|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
73839712|NCT02037984|147227698|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.1|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.1|
73839713|NCT02037984|147227699|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-4.2|||||TWO_SIDED|95.0|-20.4|5.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.6|-20.4|
73839714|NCT02037984|147227699|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|11.8|||||TWO_SIDED|95.0|-10.0|30.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||30.6|-10.0|
73839715|NCT02037984|147227699|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-1.6|||||TWO_SIDED|95.0|-18.8|10.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||10.3|-18.8|
73839716|NCT02037984|147227699|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
73839717|NCT02037984|147227699|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
73839718|NCT02037984|147227699|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
73839719|NCT02037984|147227699|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
73839720|NCT02037984|147227699|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
73839721|NCT02037984|147227699|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
73839722|NCT02037984|147227699|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
73839723|NCT02037984|147227699|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
73839724|NCT02037984|147227699|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
73839725|NCT02037984|147227699|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
73839726|NCT02037984|147227699|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|85.0|||||TWO_SIDED|95.0|65.8|93.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||93.6|65.8|
73839727|NCT02037984|147227699|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|92.9|||||TWO_SIDED|95.0|75.1|98.1|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||98.1|75.1|
73839728|NCT02037984|147227700|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
73839729|NCT02037984|147227700|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|24.3|||||TWO_SIDED|95.0|12.6|40.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||40.2|12.6|
73839730|NCT02037984|147227700|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|2.7|||||TWO_SIDED|95.0|-8.0|14.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||14.0|-8.0|
74083989|NCT03538262|147721134|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<.001
73839731|NCT02037984|147227700|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
73839732|NCT02037984|147227700|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
73839733|NCT02037984|147227700|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
73839734|NCT02037984|147227700|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
73839735|NCT02037984|147227700|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
73839736|NCT02037984|147227700|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
73839737|NCT02037984|147227700|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
73839738|NCT02037984|147227700|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
73839739|NCT02037984|147227700|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
73839740|NCT02037984|147227700|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
73839741|NCT02037984|147227700|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
73839742|NCT02037984|147227700|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.7|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.7|
73839743|NCT02037984|147227701|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
73839744|NCT02037984|147227701|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|18.4|||||TWO_SIDED|95.0|1.7|35.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||35.5|1.7|
73839745|NCT02037984|147227701|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-14.9|||||TWO_SIDED|95.0|-31.4|-1.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||-1.2|-31.4|
73839746|NCT02037984|147227701|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
73839747|NCT02037984|147227701|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
74083990|NCT03538262|147721134|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
74083991|NCT03538262|147721135|OTHER|||||||0.382|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.382
74083992|NCT03538262|147721135|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
73839748|NCT02037984|147227701|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
74022195|NCT01431287|147597085|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.040|<0.0001
74022196|NCT01431287|147597085|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0112|TWO_SIDED|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.007|0.0112
74022197|NCT01431287|147597085|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.093|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.068|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.119|0.068|<0.0001
74022198|NCT01431287|147597085|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.039|<0.0001
74022199|NCT01431287|147597085|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.013||0.9514|TWO_SIDED|95.0|-0.024|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.026|-0.024|0.9514
74022200|NCT01431287|147597085|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.069|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.119|0.069|<0.0001
73959739|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.36||0.766|ONE_SIDED|95.0|-0.87||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.87|0.7660
73959740|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.7226|ONE_SIDED|95.0|-0.8||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.80|0.7226
73959741|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.31||0.6634|ONE_SIDED|95.0|-0.65||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.65|0.6634
74022201|NCT01431287|147597085|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.032|STANDARD_ERROR_OF_MEAN|0.013||0.0131|TWO_SIDED|95.0|-0.057|-0.007||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.007|-0.057|0.0131
74022202|NCT01431287|147597085|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.061|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.086|-0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.036|-0.086|<0.0001
74022203|NCT01431287|147597085|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.0243|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.054|0.004|0.0243
74022204|NCT01431287|147597086|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.145|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.119|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.170|0.119|<0.0001
74022205|NCT01431287|147597086|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.085|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.136|0.085|<0.0001
73839749|NCT02037984|147227701|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
74083993|NCT03538262|147721136|OTHER|||||||0.688|||||||Mixed Models Analysis|||Secondary analysis for BL to Month 12||||0.688
74083994|NCT03538262|147721136|OTHER|||||||0.293|||||||Mixed Models Analysis|||Secondary analysis for BL to Month 24||||0.293
74083995|NCT03538262|147721137|OTHER|||||||0.446|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.446
74022206|NCT01431287|147597086|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.119|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.094|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.094|<0.0001
73839750|NCT02037984|147227701|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
73839751|NCT02037984|147227701|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
73839752|NCT02037984|147227701|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
73839753|NCT02037984|147227701|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
73839754|NCT02037984|147227701|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
73839755|NCT02037984|147227701|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-5.9|||||TWO_SIDED|95.0|-19.2|3.9|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||3.9|-19.2|
73839756|NCT02037984|147227701|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
73839757|NCT02037984|147227701|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.9|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.9|
74022207|NCT01431287|147597086|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.081|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.132|0.081|<0.0001
74022208|NCT01431287|147597086|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.059|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.110|0.059|<0.0001
73839758|NCT02037984|147227702|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
73839759|NCT02037984|147227702|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.0|||||TWO_SIDED|95.0|-5.5|32.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||32.0|-5.5|
74083996|NCT03538262|147721137|OTHER|||||||0.565|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.565
73839760|NCT02037984|147227702|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.6|||||TWO_SIDED|95.0|-24.2|5.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.2|-24.2|
73839761|NCT02037984|147227702|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
73839762|NCT02037984|147227702|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
73839763|NCT02037984|147227702|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
73839764|NCT02037984|147227702|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
74083997|NCT03538262|147721138|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.006
73839765|NCT02037984|147227702|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
73839766|NCT02037984|147227702|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
73839767|NCT02037984|147227702|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
73839768|NCT02037984|147227702|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|-6.9|||||TWO_SIDED|95.0|-22.1|3.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||3.0|-22.1|
73839769|NCT02037984|147227702|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
73839770|NCT02037984|147227702|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
73839771|NCT02037984|147227702|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
74022209|NCT01431287|147597086|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.013||0.047|TWO_SIDED|95.0|0.0|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.051|0.000|0.0470
73839772|NCT02037984|147227702|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|93.8|||||TWO_SIDED|95.0|78.5|98.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||98.3|78.5|
74022210|NCT01431287|147597086|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.107|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.107|<0.0001
74022211|NCT01431287|147597086|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0083|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.060|0.009|0.0083
74022212|NCT01431287|147597086|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.013||0.3329|TWO_SIDED|95.0|-0.013|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.038|-0.013|0.3329
74022213|NCT01431287|147597086|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.013||0.0958|TWO_SIDED|95.0|-0.004|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.047|-0.004|0.0958
74022214|NCT01431287|147597087|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.105|<0.0001
74022215|NCT01431287|147597087|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.086|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.139|0.086|<0.0001
74022216|NCT01431287|147597087|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.092|<0.0001
74022217|NCT01431287|147597087|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.092|<0.0001
74022218|NCT01431287|147597087|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.072|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.125|0.072|<0.0001
74022219|NCT01431287|147597087|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.3008|TWO_SIDED|95.0|-0.012|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.040|-0.012|0.3008
74083998|NCT03538262|147721138|OTHER|||||||0.937|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.937
74083999|NCT03538262|147721139|OTHER|||||||0.041|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.041
74084000|NCT03538262|147721139|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
74084001|NCT03538262|147721139|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||<0.001
74084002|NCT03538262|147721139|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
74084003|NCT03538262|147721139|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
74084004|NCT03538262|147721139|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
74084005|NCT03538262|147721139|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
74084006|NCT03538262|147721139|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
74084007|NCT03538262|147721140|OTHER|||||||0.595|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.595
74084008|NCT03538262|147721140|OTHER|||||||0.44|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.440
74022220|NCT01431287|147597087|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.105|<0.0001
74022221|NCT01431287|147597087|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.014||0.1484|TWO_SIDED|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.046|-0.007|0.1484
74084009|NCT03538262|147721140|OTHER|||||||0.909|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.909
74084010|NCT03538262|147721140|OTHER|||||||0.068|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.068
74084011|NCT03538262|147721141|OTHER|||||||0.074|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.074
74084012|NCT03538262|147721141|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
74084013|NCT03538262|147721141|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||<0.001
74084014|NCT03538262|147721141|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
74084015|NCT03538262|147721141|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
74084016|NCT03538262|147721141|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
74084017|NCT03538262|147721141|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
74084018|NCT03538262|147721141|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
74084019|NCT03538262|147721142|OTHER|||||||0.2|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.200
74084020|NCT03538262|147721142|OTHER|||||||0.888|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.888
74084021|NCT03538262|147721142|OTHER|||||||0.837|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.837
74084022|NCT03538262|147721142|OTHER|||||||0.394|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.394
74084023|NCT03538262|147721142|OTHER|||||||0.268|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||0.268
74084024|NCT03538262|147721142|OTHER|||||||0.039|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.039
74084025|NCT03538262|147721142|OTHER|||||||0.979|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||0.979
74084026|NCT03538262|147721142|OTHER|||||||0.014|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.014
74084027|NCT03538262|147721143|OTHER|||||||0.285|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.285
74084028|NCT03538262|147721143|OTHER|||||||0.267|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.267
74022222|NCT01431287|147597087|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.9981|TWO_SIDED|95.0|-0.026|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.027|-0.026|0.9981
74022223|NCT01431287|147597087|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.148|TWO_SIDED|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.046|-0.007|0.1480
74022224|NCT01431287|147597088|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.040|<0.0001
74022225|NCT01431287|147597088|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.005|TWO_SIDED|95.0|0.011|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.061|0.011|0.0050
74022226|NCT01431287|147597088|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.089|0.039|<0.0001
74022227|NCT01431287|147597088|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.088|0.037|<0.0001
74022228|NCT01431287|147597088|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.0057|TWO_SIDED|95.0|0.01|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.061|0.010|0.0057
74022229|NCT01431287|147597088|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.013||0.9633|TWO_SIDED|95.0|-0.025|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.026|-0.025|0.9633
74022230|NCT01431287|147597088|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.038|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.088|0.038|<0.0001
74022231|NCT01431287|147597088|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.025|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.054|0.004|0.0250
74022232|NCT01431287|147597088|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.002|STANDARD_ERROR_OF_MEAN|0.013||0.8949|TWO_SIDED|95.0|-0.023|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.027|-0.023|0.8949
74084029|NCT03538262|147721143|OTHER|||||||0.564|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||0.564
74084030|NCT03538262|147721143|OTHER|||||||0.034|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||0.034
74084031|NCT03538262|147721144|OTHER|||||||0.409|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.409
74084032|NCT03538262|147721144|OTHER|||||||0.149|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 0.149||||0.149
74084033|NCT04640194|147721153|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.39|2.61|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||2.61|0.39|
74084034|NCT04640194|147721153|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.46|3.27|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||3.27|0.46|
74084035|NCT04640194|147721153|OTHER||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.73|4.15|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||4.15|0.73|
74022233|NCT01431287|147597088|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0351|TWO_SIDED|95.0|0.002|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.052|0.002|0.0351
73839773|NCT02457546|147227709|NON_INFERIORITY|"The statistical hypothesis for testing the treatment difference was presented as follows:~H0: Δ ≤ -0.10 tested against the alternative hypothesis Ha: Δ \> -0.10. where:~* Δ is the difference between the success rates of Experimental (Evicel®) and Control (DuraSeal™) (Experimental minus Control)~* -0.10 is the non-inferiority difference PC is the proportion of success in DuraSeal™ Control subjects and PE is the proportion of success in EVICEL® subjects."|Difference in Success Rates|6.3|||||TWO_SIDED|95.0|-1.8|14.4||||||||14.4|-1.8|
73839774|NCT01633112|147227711|SUPERIORITY|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.0138|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA||||0.0138
73839775|NCT01633112|147227711|SUPERIORITY|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.4153|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA||||0.4153
73839776|NCT01633112|147227712|OTHER||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||<0.0001
73839777|NCT01633112|147227712|OTHER||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||<0.0001
73839778|NCT01633112|147227714|OTHER||||||<|0.0001|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.||||||<0.0001
73839779|NCT01633112|147227714|OTHER|||||||0.006|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.||||||0.0060
73839780|NCT01633112|147227715|OTHER|||||||0.0167|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses .||||||0.0167
73839781|NCT01633112|147227715|OTHER|||||||0.0011|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||0.0011
73839782|NCT01633112|147227716|OTHER|||||||0.0052|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.||||||0.0052
73839783|NCT01633112|147227716|OTHER|||||||0.0636|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.||||||0.0636
73839784|NCT01633112|147227717|OTHER|||||||0.0011||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.||||||0.0011
73839785|NCT01633112|147227717|OTHER|||||||0.0146||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.||||||0.0146
74022234|NCT01431287|147597089|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.055|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.105|0.055|<0.0001
73839786|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
74022235|NCT01431287|147597089|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.013||0.0002|TWO_SIDED|95.0|0.022|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.073|0.022|0.0002
73839787|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
73898481|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|4.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73839788|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
73839789|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
73839790|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
73839791|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
73839792|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
73839793|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
73839794|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
73839795|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
73839796|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
73839797|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
73839798|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
73839799|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
73839800|NCT01633112|147227718|OTHER|||||||0.0005|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||0.0005
73839801|NCT01633112|147227718|OTHER||||||<|0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||<0.0051
73839802|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
74022236|NCT01431287|147597089|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.101|0.051|<0.0001
73839803|NCT01633112|147227718|OTHER|||||||0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||0.0051
74022237|NCT01431287|147597089|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.061|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.036|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.086|0.036|<0.0001
73839804|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
73839805|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
73839806|NCT01633112|147227718|OTHER|||||||0.0068|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||0.0068
73839807|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
73898482|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.675||0.612|TWO_SIDED|95.0|-0.985|1.67||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.670|-0.985|0.612
73839808|NCT01633112|147227718|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
73839809|NCT01633112|147227718|OTHER|||||||0.4595|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||0.4595
73839810|NCT01633112|147227719|OTHER|||||||0.1045|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume||||||0.1045
73839811|NCT01633112|147227719|OTHER|||||||0.1358|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume||||||0.1358
73839812|NCT03992872|147227748|SUPERIORITY|The significance of the difference between groups in seroconversion rates was assessed using a Fisher's exact test. The percentage who seroconverted in each group was presented along with its 95% CI calculated using the Wilson method. The Newcombe method was use to estimate the 95% confidence interval for the difference between groups in the percentage of subjects who seroconverted.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-11.4|11.4|||Fisher Exact|||||11.4|-11.4|1
73839813|NCT03992872|147227749|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.2|||||TWO_SIDED|95.0||||P- value = NE (Not estimable due to lack of response; all baseline values in this group were \<LOD and imputed as LOD/2, or 7.5)||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\]~NE = Not estimable due to lack of response."|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
73839814|NCT03992872|147227749|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|3.11||||0.0019|TWO_SIDED|95.0|1.55|6.23|||ANOVA|P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 8: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||6.23|1.55|0.0019
74084036|NCT04640194|147721153|OTHER||Hazard Ratio (HR)|2.04|||||TWO_SIDED|95.0|0.83|5.01|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||5.01|0.83|
74084037|NCT04640194|147721153|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.35|3.66|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||3.66|0.35|
74084038|NCT04640194|147721153|OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.33|4.22|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||4.22|0.33|
74084039|NCT04640194|147721154|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-10.892|24.8734|||||Chan and Zhang exact confidence interval.|||24.8734|-10.892|
74084040|NCT04640194|147721154|OTHER||Risk Difference (RD)|20.0|||||TWO_SIDED|95.0|2.3075|43.6615|||||Chan and Zhang exact confidence interval.|||43.6615|2.3075|
74084041|NCT04640194|147721154|OTHER||Risk Difference (RD)|11.76|||||TWO_SIDED|95.0|-24.127|36.9012|||||Chan and Zhang exact confidence interval.|||36.9012|-24.127|
74084042|NCT04640194|147721155|OTHER||Risk Difference (RD)|-16.6|||||TWO_SIDED|95.0|-38.6|5.5|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||5.5|-38.6|
74084043|NCT04640194|147721155|OTHER||Risk Difference (RD)|-11.8|||||TWO_SIDED|95.0|-35.1|11.6|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||11.6|-35.1|
74084044|NCT04640194|147721155|OTHER||Risk Difference (RD)|-19.1||||0.2419|TWO_SIDED|95.0|-51.1|12.9|||The delta method and average marginal.||Calculated as alteplase dose group - standard of care alone.|Unadjusted risk difference and 95% CI is based upon average marginal effect Delta method, adjusting for treatment.||12.9|-51.1|0.2419
74084045|NCT04640194|147721156|OTHER||Risk Difference (RD)|-9.0|||||TWO_SIDED|95.0|-37.1|19.1|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.1|-37.1|
74084046|NCT04640194|147721156|OTHER||Risk Difference (RD)|-9.1|||||TWO_SIDED|95.0|-37.2|19.0|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.0|-37.2|
74084047|NCT04640194|147721156|OTHER||Risk Difference (RD)|14.5||||0.2523|TWO_SIDED|95.0|-10.3|39.3|||The delta method and average marginal.||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% CI is based upon average marginal effect Delta method, adjusting for baseline D-dimer status, age, days of NIV support and treatment.||39.3|-10.3|0.2523
74084048|NCT04640194|147721157|OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-4.4|10.6|||||Calculated as alteplase dose group - standard of care alone.|Parameters included in model: treatment,ventilation status at baseline, and age.||10.6|-4.4|
74084049|NCT04640194|147721157|OTHER||Median Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-3.2|11.8|||||Calculated as alteplase dose group - standard of care alone.|Parameters included in model: treatment,ventilation status at baseline, and age.||11.8|-3.2|
74084050|NCT04640194|147721158|OTHER||Risk Difference (RD)|-4.9|||||TWO_SIDED|95.0|-29.0|19.2|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.2|-29.0|
74084051|NCT04640194|147721158|OTHER||Risk Difference (RD)|-15.2|||||TWO_SIDED|95.0|-36.8|6.3|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||6.3|-36.8|
74084052|NCT04640194|147721159|OTHER||Median Difference (Net)|17.193|||||TWO_SIDED|95.0|-28.45|52.33|||||Calculated as alteplase dose group - standard of care alone.|Based upon Hedges-Lehmann estimator handling deaths as failure and Wilcoxon rank sum test methodology.||52.33|-28.45|
74084053|NCT04640194|147721159|OTHER||Median Difference (Final Values)|54.436|||||TWO_SIDED|95.0|0.49|110.36|||||Calculated as alteplase dose group - standard of care alone.|Based upon Hedges-Lehmann estimator handling deaths as failure and Wilcoxon rank sum test methodology.||110.36|0.49|
74084054|NCT04640194|147721161|OTHER||Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|3.6||0.9856|TWO_SIDED|95.0|-7.5|7.6|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Unadjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment.||7.6|-7.5|0.9856
74084055|NCT04640194|147721161|OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|3.8||0.8729|TWO_SIDED|95.0|-8.5|7.3|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Adjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment, the number of days under NIV support, baseline D-Dimer level and age.||7.3|-8.5|0.8729
74084056|NCT04640194|147721162|OTHER||Mean Difference (Net)|70.9|STANDARD_ERROR_OF_MEAN|35.8||0.0603|TWO_SIDED|95.0|-3.3|145.1|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Unadjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment.||145.1|-3.3|0.0603
74084057|NCT04640194|147721162|OTHER||Mean Difference (Final Values)|87.2|STANDARD_ERROR_OF_MEAN|38.5||0.0362|TWO_SIDED|95.0|6.3|168.0|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Adjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment, the number of days under NIV support, baseline D-Dimer level, baseline PaO2/FiO2 ratio and age.||168.0|6.3|0.0362
74022238|NCT01431287|147597089|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.044|STANDARD_ERROR_OF_MEAN|0.013||0.0007|TWO_SIDED|95.0|0.018|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.069|0.018|0.0007
74084058|NCT04773600|147721179|SUPERIORITY||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.962|5.183|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA Success at Week 4||5.183|1.962|<0.0001
74084059|NCT04773600|147721180|SUPERIORITY||Odds Ratio (OR)|3.37|||<|0.0001|TWO_SIDED|95.0|1.996|5.687|||Cochran-Mantel-Haenszel|Stratified by pooled study site|Stratified by pooled study site|vIGA Success at Week 4 in Participants with Baseline vIGA = 'Moderate'||5.687|1.996|<0.0001
74084060|NCT04773600|147721181|SUPERIORITY||Odds Ratio (OR)|4.42|||<|0.0001|TWO_SIDED|95.0|2.281|8.658|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Success at Week 2||8.658|2.281|<0.0001
74084061|NCT04773600|147721182|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1156|TWO_SIDED|95.0|0.832|4.782|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Success at Week 1||4.782|0.832|0.1156
74084062|NCT04773600|147721183|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0014|TWO_SIDED|95.0|1.448|5.066|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 4||5.066|1.448|0.0014
74084063|NCT04773600|147721184|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0015|TWO_SIDED|95.0|1.591|7.927|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 2||7.927|1.591|0.0015
74084064|NCT04773600|147721185|SUPERIORITY||Odds Ratio (OR)|7.84||||0.002|TWO_SIDED|95.0|1.717|35.764|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 1||35.764|1.717|0.0020
74084065|NCT04773600|147721186|SUPERIORITY||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|2.108|4.964|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|EASI-75 at Week 4||4.964|2.108|<0.0001
74084066|NCT04773600|147721187|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.0001|TWO_SIDED|95.0|2.191|5.24|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4||5.240|2.191|<0.0001
74084067|NCT04773600|147721188|SUPERIORITY||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.097|5.854|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2||5.854|2.097|<0.0001
74022239|NCT01431287|147597089|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.013||0.7755|TWO_SIDED|95.0|-0.022|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.029|-0.022|0.7755
73898483|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73839815|NCT03992872|147227749|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.88||||0.6223|TWO_SIDED|95.0|0.54|1.46|||ANOVA|P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.46|0.54|0.6223
73839816|NCT03992872|147227749|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.88||||0.6444|TWO_SIDED|95.0|0.5|1.55||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.55|0.50|0.6444
73839817|NCT03992872|147227749|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.89||||0.6198|TWO_SIDED|95.0|0.57|1.41||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 57: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.41|0.57|0.6198
73839818|NCT03992872|147227749|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.89||||0.6451|TWO_SIDED|95.0|0.55|1.45||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 182: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.45|0.55|0.6451
73839819|NCT03992872|147227750|SUPERIORITY|||||||0.0211|||||||Fisher Exact|"Day 8~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||0.0211
73839820|NCT03992872|147227750|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
73839821|NCT03992872|147227750|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 57.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
73839822|NCT03992872|147227750|SUPERIORITY|||||||0.1124|||||||Fisher Exact|"Day 182.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||0.1124
73839823|NCT03992872|147227751|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 1 : Subjects with Titer \>=40"||||>0.9999
73839824|NCT03992872|147227751|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 1: Subjects with Titer \>=160"||||>0.9999
73839825|NCT03992872|147227751|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 1: Subjects with Titer \>=640"||||1.0000
73839826|NCT03992872|147227751|SUPERIORITY|||||||0.0257|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 8 : Subjects with Titer \>=40"||||0.0257
73839827|NCT03992872|147227751|SUPERIORITY|||||||0.037|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 8: Subjects with Titer \>=160"||||0.0370
73839828|NCT03992872|147227751|SUPERIORITY|||||||0.1806|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 8: Subjects with Titer \>=640"||||0.1806
73839829|NCT03992872|147227751|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 22: Subjects with Titer \>=40"||||1.0000
73839830|NCT03992872|147227751|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 22: Subjects with Titer \>=160"||||1.0000
73839831|NCT03992872|147227751|SUPERIORITY|||||||0.0797|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 22: Subjects with Titer \>=640"||||0.0797
73839832|NCT03992872|147227751|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>=40"||||1.0000
73839833|NCT03992872|147227751|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>=160"||||1.0000
73839834|NCT03992872|147227751|SUPERIORITY|||||||0.1284|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>= 640"||||0.1284
73839835|NCT03992872|147227751|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer \>= 40"||||1.0000
73839836|NCT03992872|147227751|SUPERIORITY|||||||0.6411|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer\>=160"||||0.6411
73839837|NCT03992872|147227751|SUPERIORITY|||||||0.5382|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer\>=640"||||0.5382
73839838|NCT03992872|147227751|SUPERIORITY|||||||0.4915|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 40"||||0.4915
73839839|NCT03992872|147227751|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 160"||||>0.9999
73839840|NCT03992872|147227751|SUPERIORITY|||||||0.552|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 640"||||0.5520
73839841|NCT03992872|147227752|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.51||||0.0277|TWO_SIDED|95.0|1.05|2.19||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.19|1.05|0.0277
73839842|NCT03992872|147227752|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.83||||0.0088|TWO_SIDED|95.0|1.17|2.86||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.86|1.17|0.0088
73839843|NCT03992872|147227752|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.68||||0.0475|TWO_SIDED|95.0|1.01|2.82||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.82|1.01|0.0475
73839844|NCT03992872|147227753|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.00
73839845|NCT03992872|147227753|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.00
73839846|NCT03992872|147227754|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|45.17|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE~NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\]~NE = Not estimable due to lack of response."|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
73839847|NCT03992872|147227754|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|47.34|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\] NE = Not estimable due to lack of response."|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
73839848|NCT03992872|147227754|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|55.74|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\] NE = Not estimable due to lack of response."|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
73839849|NCT03992872|147227756|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
73839850|NCT03992872|147227756|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
73839851|NCT03992872|147227757|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 40"||||<0.0001
73839852|NCT03992872|147227757|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 160"||||<0.0001
73839853|NCT03992872|147227757|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 640"||||<0.0001
73839854|NCT03992872|147227757|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>= 40"||||<0.0001
73839855|NCT03992872|147227757|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>= 160"||||<0.0001
73839856|NCT03992872|147227757|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>=640"||||<0.0001
73839857|NCT03992872|147227757|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>= 40"||||<0.0001
73839858|NCT03992872|147227757|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29: Subjects with Titer \>= 160"||||<0.0001
73839859|NCT03992872|147227757|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29 : Subjects with Titer \>=640"||||<0.0001
73839860|NCT03992872|147227758|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|23.12|||<|0.0001|TWO_SIDED|95.0|11.54|46.35||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||46.35|11.54|<0.0001
73839861|NCT03992872|147227758|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|172.51|||<|0.0001|TWO_SIDED|95.0|106.6|279.19||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||279.19|106.60|<0.0001
73839862|NCT03992872|147227758|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|118.45|||<|0.0001|TWO_SIDED|95.0|61.76|227.16||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naive alpha group) and 95% confidence interval||227.16|61.76|<0.0001
73839863|NCT03992872|147227759|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||<0.0001
73839864|NCT03992872|147227759|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|"Day 29~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||<0.0001
73839865|NCT01537432|147227761|SUPERIORITY_OR_OTHER||difference in proportions|0.565|||<|0.001|TWO_SIDED|95.0|0.363|0.768|||Fisher Exact|||||0.768|0.363|<0.001
73839866|NCT00889005|147227763|SUPERIORITY_OR_OTHER|||||||0.927|||||||ANOVA|||||||0.927
73839867|NCT03523585|147227777|SUPERIORITY||Hazard Ratio (HR)|0.3589|||<|1e-06|TWO_SIDED|95.0|0.284|0.4535||Stratified Log-rank p-value|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.4535|0.2840|<0.000001
74022240|NCT01431287|147597089|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.039|<0.0001
73839868|NCT03523585|147227778|SUPERIORITY||Hazard Ratio (HR)|0.6575||||0.0021|TWO_SIDED|95.0|0.5023|0.8605||Stratified Log-rank p-value|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.8605|0.5023|0.0021
73839869|NCT03523585|147227779|SUPERIORITY||||||<|0.0001||||||Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|Cochran-Mantel-Haenszel|||Statistical Analysis for BICR Assessment||||<0.0001
73839870|NCT03523585|147227779|SUPERIORITY||||||<|0.0001||||||Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|Cochran-Mantel-Haenszel|||Statistical Analysis for Investigator Assessment||||<0.0001
73839871|NCT03523585|147227781|SUPERIORITY||Hazard Ratio (HR)|0.2828|||<|1e-06|TWO_SIDED|95.0|0.227|0.3524||Stratified Log-rank p-value.|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.3524|0.2270|<0.000001
73839872|NCT03704922|147227782|OTHER|||||||0.051|||||||Fisher Exact|||||||0.051
73839873|NCT00836901|147227844|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.7||||||90.0|93.19|102.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.43|93.19|
73839874|NCT00836901|147227845|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.28||||||90.0|97.09|101.53|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.53|97.09|
73959742|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.35||0.7598|ONE_SIDED|95.0|-0.83||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.83|0.7598
73959743|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.34||0.53|ONE_SIDED|95.0|-0.59||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.59|0.5300
73959744|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.3||0.7054|ONE_SIDED|95.0|-0.66||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.66|0.7054
74084068|NCT04773600|147721189|SUPERIORITY||Odds Ratio (OR)|2.56||||0.005|TWO_SIDED|95.0|1.312|4.993|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1||4.993|1.312|0.0050
73839875|NCT00836901|147227846|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.64||||||90.0|96.12|99.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||99.19|96.12|
73839876|NCT00836901|147227847|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.59||||||90.0|85.64|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.47|85.64|
73839877|NCT00836901|147227848|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.44||||||90.0|87.83|101.54|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.54|87.83|
73839878|NCT00836901|147227849|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.08||||||90.0|87.19|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.52|87.19|
73839879|NCT00830336|147227850|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|103.08||||||90.0|95.41|111.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.37|95.41|
73839880|NCT00830336|147227851|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|105.84||||||90.0|99.33|112.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.77|99.33|
73839881|NCT00830336|147227852|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|107.04||||||90.0|99.96|114.62|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114.62|99.96|
73839882|NCT01837550|147227885|NON_INFERIORITY_OR_EQUIVALENCE|To ensure a between-group effect of 80% at the 5% significance level it was estimated that 60 participants need to be included in the study. An effect size of Cohen's d=0.80 was expected. The expected standardized mean difference on the HHIE formed the basis for the obtained power.||||||0.685|||||||Mixed Models Analysis|||||||0.685
73839883|NCT00928720|147227895|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.045|TWO_SIDED||||||Mixed Models Analysis|||||||0.045
73839884|NCT02633527|147227911|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.0899|TWO_SIDED|95.0|-13.4|1.0|||ANOVA|||||1.0|-13.4|0.0899
73839885|NCT02633527|147227911|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.031|TWO_SIDED|95.0|-15.1|-0.7|||ANOVA|||||-0.7|-15.1|0.0310
73839886|NCT02633527|147227911|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.0268|TWO_SIDED|95.0|-15.3|-0.9|||ANOVA|||||-0.9|-15.3|0.0268
74022241|NCT01431287|147597089|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.013||0.0118|TWO_SIDED|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.007|0.0118
73839887|NCT02633527|147227911|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.0209|TWO_SIDED|95.0|-15.8|-1.3|||ANOVA|||||-1.3|-15.8|0.0209
73839888|NCT02633527|147227912|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.1305|TWO_SIDED|95.0|-1.0|0.1|||ANOVA|||||0.1|-1.0|0.1305
73839889|NCT02633527|147227912|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.1376|TWO_SIDED|95.0|-1.0|0.1|||ANOVA|||||0.1|-1.0|0.1376
73839890|NCT02633527|147227912|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.009|TWO_SIDED|95.0|-1.3|-0.2|||ANOVA|||||-0.2|-1.3|0.0090
73839891|NCT02633527|147227912|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0546|TWO_SIDED|95.0|-1.1|0.0|||ANOVA|||||0.0|-1.1|0.0546
73839892|NCT02633527|147227913|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0708|TWO_SIDED|95.0|-1.3|0.1|||ANCOVA|||||0.1|-1.3|0.0708
73839893|NCT02633527|147227913|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0309|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|||||-0.1|-1.4|0.0309
73839894|NCT02633527|147227913|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0148|TWO_SIDED|95.0|-1.5|-0.2|||ANCOVA|||||-0.2|-1.5|0.0148
73839895|NCT02633527|147227913|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0136|TWO_SIDED|95.0|-1.6|-0.2|||ANCOVA|||||-0.2|-1.6|0.0136
73839896|NCT04135443|147227943|SUPERIORITY||Odds Ratio (OR)|1.027||||0.94|TWO_SIDED|95.0|0.511|2.063|||Regression, Logistic|||||2.063|0.511|0.94
73839897|NCT04135443|147227945|SUPERIORITY||Slope|0.064||||0.455|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.455
73839898|NCT04135443|147227946|SUPERIORITY||Slope|0.026||||0.702|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.702
73839899|NCT04135443|147227947|SUPERIORITY||Slope|0.049||||0.375|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.375
73839900|NCT04135443|147227948|SUPERIORITY||Slope|0.076||||0.313|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.313
73839901|NCT04135443|147227949|SUPERIORITY||Slope|-0.01||||0.89|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.890
73839902|NCT03856177|147227969|OTHER|||||||0.071|||||||t-test, 2 sided|||||||.071
73839903|NCT03460704|147227972|SUPERIORITY||LS Mean rate ratio|1.004||||0.97889|TWO_SIDED|95.0|0.747|1.349|||negative binomial model|||The number of NCFB pulmonary exacerbations was compared between treatment groups using a negative binomial model including treatment, country, and baseline use of stable concomitant therapy with oral macrolides as fixed effects and log-exposure time on treatment as an offset.||1.349|0.747|0.97889
73839904|NCT01767857|147227990|SUPERIORITY|||||||0.613|||||||Log Rank|||||||0.613
73839905|NCT01767857|147227991|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
73839906|NCT01767857|147227992|SUPERIORITY|||||||0.541|||||||ANCOVA|||Statistical Analysis for Global Health Status/Qol||||0.541
74022242|NCT01431287|147597089|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.013||0.2416|TWO_SIDED|95.0|-0.01|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.040|-0.010|0.2416
74022243|NCT01431287|147597089|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.013||0.1792|TWO_SIDED|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.043|-0.008|0.1792
74084069|NCT00500318|147721200|SUPERIORITY_OR_OTHER||Least Square Mean|116.44|STANDARD_ERROR_OF_MEAN|40.113||0.0042|TWO_SIDED|95.0|37.28|195.61|||ANCOVA|||||195.610|37.280|0.0042
74084070|NCT02655224|147721232|SUPERIORITY|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|42.071|||<|0.0001|TWO_SIDED|95.0|5.113|346.181|||Fisher's Exact Test||Relugolix 40 mg/Placebo|||346.181|5.113|<0.0001
74084071|NCT02655224|147721233|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|29.176|||||TWO_SIDED|95.0|3.555|239.478|||||Relugolix 40 mg/Placebo|||239.478|3.555|
74084072|NCT02655224|147721234|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-1.05|0.069|||||Relugolix 40 mg-Placebo|||0.069|-1.050|
74084073|NCT02655224|147721235|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|11.96|||||TWO_SIDED|95.0|-3.201|27.112|||||Relugolix 40 mg-Placebo|||27.112|-3.201|
74084074|NCT02655224|147721236|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.625|||||TWO_SIDED|95.0|1.605|19.709|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56||19.709|1.605|
74084075|NCT02655224|147721236|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|9.865|||||TWO_SIDED|95.0|2.784|34.955|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84||34.955|2.784|
74084076|NCT02655224|147721237|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.438|||||TWO_SIDED|95.0|1.071|27.609|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56||27.609|1.071|
74084077|NCT02655224|147721237|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|12.794|||||TWO_SIDED|95.0|2.603|62.88|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84||62.880|2.603|
74084078|NCT02655224|147721238|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|0.09|||||TWO_SIDED|95.0|-0.574|0.745|||||Relugolix 40 mg-Placebo|Day 1 to 28||0.745|-0.574|
74084079|NCT02655224|147721238|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.57|||||TWO_SIDED|95.0|-1.19|0.049|||||Relugolix 40 mg-Placebo|Day 29 to 56||0.049|-1.190|
73839907|NCT01767857|147227992|SUPERIORITY|||||||0.56|||||||ANCOVA|||Statistical Analysis for Pain||||0.560
73839908|NCT01767857|147227992|SUPERIORITY|||||||0.603|||||||ANCOVA|||Statistical Analysis for Fatigue||||0.603
73839909|NCT01767857|147227992|SUPERIORITY|||||||0.485|||||||ANCOVA|||Statistical Analysis for Appetite Loss||||0.485
73839910|NCT01767857|147227993|SUPERIORITY|||||||0.21|||||||ANCOVA|||||||0.210
73839911|NCT01767857|147227994|SUPERIORITY|||||||0.768|||||||Log Rank|||||||0.768
73898484|NCT02880956|147328894|SUPERIORITY||LS Mean of Difference|0.5|STANDARD_ERROR_OF_MEAN|0.696||0.475|TWO_SIDED|95.0|-0.872|1.867||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.867|-0.872|0.475
73839912|NCT02844075|147228020|SUPERIORITY||||||||||||||||||For sample size calculation, Minimax design to evaluate the null hypothesis that the true pCR rate will be 10% and the alternative hypothesis that the pCR rate≥ 30%, with type I error (α) level of 10% and type II error (β) of 0.10. If 1 or more successes are observed in the first 16 patients, accrual for that stratum will be continued until a total of 25 patients. If, of these 25 patients, 5 or more pCR, an additional investigation is warranted. Allowing for a follow-up loss rate of 10 %, the total sample size is expected as 28. For biomarker evaluation, the categorical groups were investigated to evaluated possible association with response and/or survival. Associations were analyzed by χ2 test or Fisher's exact test for categorical variables. The Kaplan-Meier method was used to analyze survival outcomes (EFS, OS, and DFS). To compare PD-L1 expression between paired pre- and post-neoadjuvant treatment with associated of pCR, the Wilcoxon signed-rank test was used.|||
73839913|NCT03657407|147228026|SUPERIORITY||Mean Difference (Final Values)|-0.65||||0.17|TWO_SIDED|95.0|-0.71|2.0|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||2.0|-0.71|0.17
73839914|NCT03657407|147228027|SUPERIORITY||Mean Difference (Final Values)|-2.02||||0.29|TWO_SIDED|95.0|-5.4|9.5|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||9.5|-5.4|0.29
73839915|NCT03657407|147228028|SUPERIORITY||Median Difference (Final Values)|-19.31||||0.05|TWO_SIDED|95.0|-43.1|4.5|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||4.5|-43.1|0.05
73839916|NCT03657407|147228029|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.42|TWO_SIDED|95.0|0.42|1.7|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||1.7|0.42|0.42
73839917|NCT02628145|147228030|OTHER||Mean Difference (Final Values)|-0.01||||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
73839918|NCT02628145|147228031|SUPERIORITY|||||||0.88|||||||Chi-squared|||||||0.88
73839919|NCT02628145|147228032|SUPERIORITY|||||||0.068|||||||Fisher Exact|||||||0.068
73839920|NCT02628145|147228033|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||||||0.48
73839921|NCT02628145|147228034|SUPERIORITY|||||||0.52|||||||Mixed Models Analysis|||||||0.52
73839922|NCT02628145|147228035|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73839923|NCT02628145|147228036|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73839924|NCT02628145|147228037|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73839925|NCT02628145|147228038|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73839926|NCT02628145|147228040|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
74022244|NCT01431287|147597090|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.074|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.125|0.074|<0.0001
73839927|NCT02470377|147228053|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.0439||||||Only p-values \<0.05 were considered significant|ANOVA|One way ANOVA, immediate DHI changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.0439
73839928|NCT02470377|147228054|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.0316|||||||ANOVA|One way ANOVA, immediate MBRS changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.0316
73839929|NCT02470377|147228055|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.1754|||||||ANOVA|One way ANOVA, immediate HADS changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.1754
73839930|NCT00452400|147228070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.027||0.0233||95.0|0.008|0.113|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.113|0.008|0.0233
73839931|NCT00452400|147228070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.027||0.0003||95.0|0.044|0.149|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.149|0.044|0.0003
73839932|NCT00452400|147228070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.072|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.175|0.072|<0.0001
73839933|NCT00452400|147228070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.08|0.185|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.185|0.080|<0.0001
73839934|NCT00452400|147228071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.025||0.0004||95.0|0.039|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|0.039|0.0004
73839935|NCT00452400|147228071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.088|0.186|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.186|0.088|<0.0001
74022245|NCT01431287|147597090|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.033|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.084|0.033|<0.0001
74084080|NCT02655224|147721238|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.54|||||TWO_SIDED|95.0|-1.074|-0.012|||||Relugolix 40 mg-Placebo|Day 57 to 84||-0.012|-1.074|
74084081|NCT02655224|147721239|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|4.17|||||TWO_SIDED|95.0|-11.507|19.839|||||Relugolix 40 mg-Placebo|Day 1 to 28||19.839|-11.507|
73839936|NCT00452400|147228071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.08|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.176|0.080|<0.0001
74084082|NCT02655224|147721239|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|12.7|||||TWO_SIDED|95.0|-3.098|28.494|||||Relugolix 40 mg-Placebo|Day 29 to 56||28.494|-3.098|
74084083|NCT02655224|147721239|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|11.6|||||TWO_SIDED|95.0|-3.554|26.745|||||Relugolix 40 mg-Placebo|Day 57 to 84||26.745|-3.554|
74084084|NCT02104817|147721266|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.837|TWO_SIDED|95.0|0.9|1.09||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.09|0.90|0.837
74084085|NCT02104817|147721267|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.269|TWO_SIDED|95.0|0.84|1.05||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.05|0.84|0.269
74084086|NCT02104817|147721268|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.402|TWO_SIDED|95.0|0.93|1.19||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.19|0.93|0.402
74084087|NCT02104817|147721269|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.87|1.16||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.16|0.87|0.940
74084088|NCT02104817|147721270|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.092|TWO_SIDED|95.0|0.81|1.02||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.02|0.81|0.092
74084089|NCT02104817|147721271|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.016|TWO_SIDED|95.0|0.75|0.97||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||0.97|0.75|0.016
74084090|NCT02104817|147721272|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.372|TWO_SIDED|95.0|0.9|1.31||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.31|0.90|0.372
74084091|NCT02104817|147721273|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.336|TWO_SIDED|95.0|0.89|1.41||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.41|0.89|0.336
74084092|NCT02104817|147721274|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.112|TWO_SIDED|95.0|0.97|1.31||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.31|0.97|0.112
74084093|NCT02104817|147721275|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.091|TWO_SIDED|95.0|0.97|1.42||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.42|0.97|0.091
74084094|NCT02104817|147721276|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.408|TWO_SIDED|95.0|0.83|1.08||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.08|0.83|0.408
74084095|NCT02104817|147721277|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.233|TWO_SIDED|95.0|0.63|1.12||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.12|0.63|0.233
74084096|NCT02104817|147721278|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.81|1.17||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.17|0.81|0.770
74084097|NCT02104817|147721279|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.278|TWO_SIDED|95.0|0.9|1.45||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.45|0.90|0.278
74084098|NCT04633642|147721300|SUPERIORITY||Mean Difference (Final Values)|1.05|STANDARD_DEVIATION|0.74|<|0.01|TWO_SIDED|||||The threshold for statistical significances was p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
74084099|NCT04633642|147721301|SUPERIORITY||Mean Difference (Final Values)|1.61|STANDARD_DEVIATION|0.17|<|0.01|TWO_SIDED|||||The threshold for statistical significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
74084100|NCT04633642|147721302|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.79|<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74084101|NCT04633642|147721303|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_DEVIATION|0.44||0.01|TWO_SIDED|||||The threshold for statistical significance was p\<0.05|t-test, 2 sided|||We analyzed 51 patients (24 in surgical group and 27 in UAW group) with a statistical power of 0.80 and an alpha of 0.05, with a power of the clinical di↵erence of 37% to detect a statistically significant between groups.||||0.01
74084102|NCT04633642|147721304|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.93|TWO_SIDED|||||The threshold for statistics significance was p\<0.05|t-test, 2 sided|||||||0.93
74084103|NCT04633642|147721305|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.18||0.711|TWO_SIDED||||||t-test, 2 sided|||We analyzed 51 patients (24 in surgical group and 27 in UAW group) with a statistical power of 0.80 and an alpha of 0.05, with a power of the clinical difference of 37% to detect a statistically significant between groups.||||0.711
74084104|NCT03223909|147721306|NON_INFERIORITY|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of groups in the baseline visit versus final visit"||||||0.08|||||||ANOVA|||||||0.080
73839937|NCT00452400|147228071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.12|0.218|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.218|0.120|<0.0001
73839938|NCT00452400|147228072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.026||0.0011||95.0|0.034|0.136|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.136|0.034|0.0011
73839939|NCT00452400|147228072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.07|0.173|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.173|0.070|<0.0001
73839940|NCT00452400|147228072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.075|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.175|0.075|<0.0001
73839941|NCT00452400|147228072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.077|0.179|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.179|0.077|<0.0001
73839942|NCT00452400|147228073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.044||0.0127||95.0|0.024|0.197|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.197|0.024|0.0127
73839943|NCT00452400|147228073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001||95.0|0.087|0.261|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.261|0.087|<0.0001
73839944|NCT00452400|147228073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.043||0.0001||95.0|0.084|0.255|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.255|0.084|0.0001
73839945|NCT00452400|147228073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.044||0.0001||95.0|0.084|0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.258|0.084|0.0001
73839946|NCT00452400|147228074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.052||0.0836||95.0|-0.012|0.192|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.192|-0.012|0.0836
73839947|NCT00452400|147228074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.052||0.0011||95.0|0.068|0.274|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.274|0.068|0.0011
73839948|NCT00452400|147228074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.051||0.0037||95.0|0.049|0.25|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.250|0.049|0.0037
73839949|NCT00452400|147228074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.052||0.0047||95.0|0.046|0.251|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.251|0.046|0.0047
73839950|NCT00452400|147228075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.051||0.0695||95.0|-0.008|0.195|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.195|-0.008|0.0695
73839951|NCT00452400|147228075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.052||0.0018||95.0|0.061|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.264|0.061|0.0018
73839952|NCT00452400|147228075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.051||0.0008||95.0|0.072|0.272|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.272|0.072|0.0008
73839953|NCT00452400|147228075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.052||0.0006||95.0|0.077|0.281|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.281|0.077|0.0006
73839954|NCT00452400|147228076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.078|0.204|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.204|0.078|<0.0001
73839955|NCT00452400|147228076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.099|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.225|0.099|<0.0001
73839956|NCT00452400|147228076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.151|0.275|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.275|0.151|<0.0001
73839957|NCT00452400|147228076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.151|0.277|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.277|0.151|<0.0001
73839958|NCT00452400|147228077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.097|0.231|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.231|0.097|<0.0001
73839959|NCT00452400|147228077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.102|0.237|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.237|0.102|<0.0001
73839960|NCT00452400|147228077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.152|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.284|0.152|<0.0001
73839961|NCT00452400|147228077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.157|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.292|0.157|<0.0001
73839962|NCT00452400|147228078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.15|0.373|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.373|0.150|<0.0001
73839963|NCT00452400|147228078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.171|0.395|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.395|0.171|<0.0001
73839964|NCT00452400|147228078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.311|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.201|0.421|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.421|0.201|<0.0001
73839965|NCT00452400|147228078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.192|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.416|0.192|<0.0001
73839966|NCT00452400|147228079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.167|0.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.409|0.167|<0.0001
73839967|NCT00452400|147228079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.159|0.401|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.401|0.159|<0.0001
73839968|NCT00452400|147228079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.178|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.416|0.178|<0.0001
73839969|NCT00452400|147228079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.164|0.407|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.407|0.164|<0.0001
73839970|NCT00452400|147228080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.09|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.176|0.090|<0.0001
73839971|NCT00452400|147228080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.128|0.215|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.215|0.128|<0.0001
73839972|NCT00452400|147228080|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.162|0.247|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.247|0.162|<0.0001
73839973|NCT00452400|147228080|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.159|0.246|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.246|0.159|<0.0001
73839974|NCT00452400|147228081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.131|0.243|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.243|0.131|<0.0001
73959745|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.45||0.8851|ONE_SIDED|95.0|-1.3||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.30|0.8851
74084105|NCT03223909|147721306|NON_INFERIORITY|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis between groups in the final visit"||||||0.848|||||||ANOVA|||||||0.848
73839975|NCT00452400|147228081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.159|0.271|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.271|0.159|<0.0001
73839976|NCT00452400|147228081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.163|0.273|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.273|0.163|<0.0001
73839977|NCT00452400|147228081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.191|0.304|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.304|0.191|<0.0001
73839978|NCT00452400|147228082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.1|0.219|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.219|0.100|<0.0001
73839979|NCT00452400|147228082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.134|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.253|0.134|<0.0001
74084106|NCT03223909|147721307|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.468|||||||Chi-squared, Corrected|||||||0.468
74084107|NCT03223909|147721308|NON_INFERIORITY|population analysis was per protocol||||||0.0001|||||||ANOVA|||||||0.0001
74084108|NCT03223909|147721308|NON_INFERIORITY|population analysis was per protocol||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.650
73839980|NCT00452400|147228082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.144|0.262|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.262|0.144|<0.0001
73839981|NCT00452400|147228082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.145|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.264|0.145|<0.0001
73839982|NCT00452400|147228083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.101|0.209|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.209|0.101|<0.0001
73839983|NCT00452400|147228083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.131|0.239|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.239|0.131|<0.0001
73839984|NCT00452400|147228083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.178|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.284|0.178|<0.0001
73839985|NCT00452400|147228083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.177|0.286|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.286|0.177|<0.0001
73839986|NCT00452400|147228084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.14|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.264|0.140|<0.0001
73839987|NCT00452400|147228084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.169|0.294|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.294|0.169|<0.0001
73839988|NCT00452400|147228084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.172|0.295|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.295|0.172|<0.0001
73839989|NCT00452400|147228084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.259|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.197|0.322|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.322|0.197|<0.0001
74084109|NCT03223909|147721309|NON_INFERIORITY|"It was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit."||||||0.003|||||||ANOVA|||||||0.003
73839990|NCT00452400|147228085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.101|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.228|0.101|<0.0001
73839991|NCT00452400|147228085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.125|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.252|0.125|<0.0001
73839992|NCT00452400|147228085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.14|0.266|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.266|0.140|<0.0001
73839993|NCT00452400|147228085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.137|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.265|0.137|<0.0001
73839994|NCT00452400|147228086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.039||0.2392||95.0|-0.03|0.121|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.121|-0.030|0.2392
73839995|NCT00452400|147228086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.038||0.0001||95.0|0.072|0.222|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.222|0.072|0.0001
73839996|NCT00452400|147228086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.099|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.253|0.099|<0.0001
73839997|NCT00452400|147228086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.039||0.0001||95.0|0.076|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.228|0.076|0.0001
73839998|NCT00452400|147228087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.039||0.0309||95.0|0.008|0.162|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.162|0.008|0.0309
73839999|NCT00452400|147228087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.098|0.25|||ANCOVA||Olo 2 mcg qd minus Placebo|||0.250|0.098|<0.0001
73840000|NCT00452400|147228087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|0.072|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.228|0.072|0.0002
73840001|NCT00452400|147228087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.039||0.0006||95.0|0.059|0.214|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.214|0.059|0.0006
74084110|NCT03223909|147721309|NON_INFERIORITY|It was considered as not inferior when the treatments did not present differences greater than 20% Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit.||||||0.003|||||||ANOVA|||||||0.003
74022246|NCT01431287|147597090|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.082|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.057|0.107||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.107|0.057|<0.0001
74084111|NCT03223909|147721310|NON_INFERIORITY|"the statistical analysis was carried out by intention to treat~It was considered as not inferior when the treatments did not present differences greater than 20%"||||||0.93|||||||Chi-squared|||||||0.930
74084112|NCT03223909|147721311|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.548|||||||ANOVA|||||||0.548
74084113|NCT03223909|147721312|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.17|||||||ANOVA|||||||0.170
74084114|NCT03223909|147721313|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.085|||||||Chi-squared, Corrected|||||||0.085
74022247|NCT01431287|147597090|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.013||0.0002|TWO_SIDED|95.0|0.023|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.073|0.023|0.0002
74022248|NCT01431287|147597090|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.013||0.0014|TWO_SIDED|95.0|0.016|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.067|0.016|0.0014
74022249|NCT01431287|147597090|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.013||0.1747|TWO_SIDED|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.043|-0.008|0.1747
74022250|NCT01431287|147597090|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.091|0.040|<0.0001
74022251|NCT01431287|147597090|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.013||0.0016|TWO_SIDED|95.0|0.016|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.066|0.016|0.0016
74022252|NCT01431287|147597090|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0081|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.060|0.009|0.0081
74084115|NCT01628549|147721314|SUPERIORITY||Difference in Least Squares Means|1.53||||0.4344|TWO_SIDED|95.0|-2.32|5.38|||ANCOVA|||||5.38|-2.32|0.4344
74084116|NCT01628549|147721314|SUPERIORITY||Difference in Least Squares Means|4.46||||0.0266|TWO_SIDED|95.0|0.52|8.4|||ANCOVA|||||8.40|0.52|0.0266
73840002|NCT00452400|147228088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.043||0.215||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|-0.031|0.2150
74084117|NCT01628549|147721314|SUPERIORITY||Difference in Least Squares Means|4.37||||0.0317|TWO_SIDED|95.0|0.39|8.36|||ANCOVA|||||8.36|0.39|0.0317
74084118|NCT01628549|147721315|SUPERIORITY||Difference vs placebo in success rate|3.4||||0.33|TWO_SIDED|95.0|-7.82|14.38|||Cochran-Mantel-Haenszel|||||14.38|-7.82|0.3300
74084119|NCT01628549|147721315|SUPERIORITY||Difference vs placebo in success rate|13.2||||0.0159|TWO_SIDED|95.0|0.54|25.6|||Cochran-Mantel-Haenszel|||||25.60|0.54|0.0159
74084120|NCT01628549|147721315|SUPERIORITY||Difference vs placebo in success rate|4.1||||0.4834|TWO_SIDED|95.0|-7.44|15.87|||Cochran-Mantel-Haenszel|||||15.87|-7.44|0.4834
74084121|NCT01405469|147721326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.44|STANDARD_DEVIATION|2.66|<|0.001||95.0|||||t-test, 2 sided|||this pilot study was created ro evaluate sample size for the following multicenter study, based on manometric outcomes. Mean values between baseline and follow-up were compared using Student ' s t -test for paired samples. P values less then 0.05, two-sided, were considered significant.R 2.13.1(R Development Core Team (2011). Subgroups (partial vs. complete myotomy) were compared using an analysis of variance test adjusted for initial values.||||<0.001
74084122|NCT00974350|147721346|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.353||0.0031|TWO_SIDED|95.0|-1.84|-0.44|||ANOVA|LS Mean difference from SABER-Placebo||Pain Intensity on Movement AUCs1-72 hours Including Pain Assessed Upon Taking Opioid Rescue - ITT||-0.44|-1.84|0.0031
74084123|NCT00974350|147721347|SUPERIORITY|||||||0.0909|||||||Cochran-Mantel-Haenszel|Stratified by pooled study sites||Proportion of Patients Not Taking Any Supplemental Opioid Analgesic Medication||||0.0909
74088230|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.13|-0.56|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.56|-1.13|<.0001
73840003|NCT00452400|147228088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.212|0.046|0.0024
73840004|NCT00452400|147228088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.043||0.023||95.0|0.014|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.184|0.014|0.0230
73840005|NCT00452400|147228088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.043||0.0333||95.0|0.007|0.177|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.177|0.007|0.0333
73840006|NCT00452400|147228089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.043||0.2158||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|-0.031|0.2158
73840007|NCT00452400|147228089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.212|0.046|0.0024
73840008|NCT00452400|147228089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.043||0.0013||95.0|0.055|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.225|0.055|0.0013
73840009|NCT00452400|147228089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.043||0.0376||95.0|0.005|0.174|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.174|0.005|0.0376
73840010|NCT00452400|147228090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.705|STANDARD_ERROR_OF_MEAN|5.916||0.0211|TWO_SIDED|95.0|2.07|25.34|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||25.340|2.070|0.0211
73840011|NCT00452400|147228090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.285|STANDARD_ERROR_OF_MEAN|5.951||0.0004|TWO_SIDED|95.0|9.581|32.99|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||32.990|9.581|0.0004
73840012|NCT00452400|147228090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.077|STANDARD_ERROR_OF_MEAN|5.832|<|0.0001|TWO_SIDED|95.0|26.607|49.546|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||49.546|26.607|<.0001
73840013|NCT00452400|147228090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.063|STANDARD_ERROR_OF_MEAN|5.99||0.0001|TWO_SIDED|95.0|11.282|34.845|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||34.845|11.282|0.0001
73840014|NCT00452400|147228091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.446|STANDARD_ERROR_OF_MEAN|6.283||0.0973|TWO_SIDED|95.0|-1.911|22.803|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||22.803|-1.911|0.0973
73840015|NCT00452400|147228091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.333|STANDARD_ERROR_OF_MEAN|6.36||0.0005|TWO_SIDED|95.0|9.824|34.842|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||34.842|9.824|0.0005
73840016|NCT00452400|147228091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.232|STANDARD_ERROR_OF_MEAN|6.192|<|0.0001|TWO_SIDED|95.0|26.054|50.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||50.409|26.054|<.0001
73840017|NCT00452400|147228091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.408|STANDARD_ERROR_OF_MEAN|6.403|<|0.0001|TWO_SIDED|95.0|12.814|38.002|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||38.002|12.814|<.0001
73840018|NCT00452400|147228092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.364||0.1541|TWO_SIDED|95.0|-1.237|0.196|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.196|-1.237|0.1541
73840019|NCT00452400|147228092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.367||0.7065|TWO_SIDED|95.0|-0.583|0.859|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.859|-0.583|0.7065
73840020|NCT00452400|147228092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.964|STANDARD_ERROR_OF_MEAN|0.359||0.0076|TWO_SIDED|95.0|-1.671|-0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.258|-1.671|0.0076
73840021|NCT00452400|147228092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.414|STANDARD_ERROR_OF_MEAN|0.369||0.2626|TWO_SIDED|95.0|-1.138|0.311|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.311|-1.138|0.2626
73840022|NCT00562861|147228121|SUPERIORITY_OR_OTHER||F value|1.88||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
73959746|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.44||0.7575|ONE_SIDED|95.0|-1.05||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.05|0.7575
73959747|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.39||0.4325|ONE_SIDED|95.0|-0.58||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.58|0.4325
73840023|NCT04349098|147228122|SUPERIORITY||Odds Ratio (OR)|0.84||||0.675|TWO_SIDED|95.0|0.39|1.79|||Cochran-Mantel-Haenszel|||||1.79|0.39|0.6750
74084124|NCT01344018|147721357|SUPERIORITY|"Time assessment biases were taken into account for the primary endpoint:~* Surgery alone arm: abdominal recurrence occurring prior to week 14 assessment was counted as occurring at week 14; progression occurring after the week 14 was counted as occurring at week 24.~* Preoperative RT arm: abdominal recurrence occurring was counted as occurring at week 14; and any abdominal recurrence occurring after and prior to or during the week 24 will be counted as occurring at week 24."|Hazard Ratio (HR)|1.01||||0.955|TWO_SIDED|95.0|0.71|1.44||A 5% significance level was considered as a threshold for statistical significance.|Regression, Cox|The time assessment biases correction described before was not applied to patients for whom death was the first event.|The arm having surgery alone was the reference arm.|Sample size was determined to provide 90% power for detecting a Hazard Ratio (HR)=0.52 (which corresponds to a 20% difference in ARFS rate at 5 years, from 50% in the surgery arm to 70% in the experimental arm) at a global 2-sided 5% significance level assuming ARFS followed an exponential distribution in both arms. This test required 102 events at the time of the statistical analysis.||1.44|0.71|0.955
74084125|NCT01344018|147721362|SUPERIORITY|ARFI was described using cumulative incidence curves. ARFI was compared between the two treatment arms using a Fine and Gray model.|Hazard Ratio (HR)|1.09||||0.658|TWO_SIDED|95.0|0.74|1.6||A 5% significance level was considered as a threshold for statistical significance.|Fine and Gray model|||||1.60|0.74|0.658
73898485|NCT02880956|147328894|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|4.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
74084126|NCT01344018|147721363|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.595|TWO_SIDED|95.0|0.58|1.36||A 5% significance level was considered as a threshold for statistical significance.|Regression, Cox|||||1.36|0.58|0.595
74084127|NCT01344018|147721364|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.615|TWO_SIDED|95.0|0.65|2.05|||Regression, Cox|||||2.05|0.65|0.615
74084128|NCT05070754|147721365|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
74084129|NCT05070754|147721366|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
74084130|NCT05070754|147721367|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
74084131|NCT05070754|147721368|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74084132|NCT05070754|147721369|SUPERIORITY|||||||0.142|||||||Wilcoxon Signed Rank Test|||Null hypothesis: there was no difference in median pain levels between SOC and NTAP treated lesions.||||0.142
74084133|NCT04404907|147721391|OTHER|ANOVA||||||0.02|||||||ANOVA|||feel more attractive||||0.02
74084134|NCT04404907|147721391|OTHER|ANOVA||||||0.001|||||||ANOVA|||tanning helps relax||||0.001
74084135|NCT04404907|147721391|OTHER|||||||0.34|||||||ANOVA|||confident with a tan||||0.34
74084136|NCT04404907|147721391|OTHER|||||||0.0004|||||||ANOVA|||Social activity||||0.0004
74084137|NCT04404907|147721391|OTHER|||||||0.66|||||||ANOVA|||Important to protect skin from the sun||||0.66
74084138|NCT04404907|147721391|OTHER|||||||0.16|||||||ANOVA|||Concern about develop skin cancer||||0.16
74084139|NCT04404907|147721391|OTHER|||||||0.29|||||||ANOVA|||Chances of getting skin cancer are high||||0.29
74084140|NCT01742208|147721408|SUPERIORITY||LS Mean Difference|-25.14||||0.007|TWO_SIDED|95.0|-42.78|-7.49||Threshold for significance at 0.05 level.|ANCOVA||Difference is sotagliflozin - placebo|Between-group comparison of the 2 Expansion Groups was based on an ANCOVA model with covariates of baseline mean total daily bolus insulin, treatment group, factor used to stratify the randomization (screening A1C \<= 8%, \> 8%), and random effect of participant\*treatment group.||-7.49|-42.78|0.007
74084141|NCT01091363|147721439|SUPERIORITY||Odds Ratio (OR)|4.67|||<|0.01|TWO_SIDED|95.0|1.67|12.99|||Regression, Logistic|||||12.99|1.67|<0.01
74084142|NCT01091363|147721440|SUPERIORITY_OR_OTHER|Hayes' PROCESS computation tool for a serial multiple mediator model predicting a binary logistic outcome.|Mean Difference (Net)|1.92||||0.02|TWO_SIDED|95.0|0.34|6.32|||Mediation Analysis|||Mediation analyses were performed to examine the effect of the intervention on abstinence via the three theoretic variables (attitudes, perceived family norms, and self-efficacy), using the Hayes' PROCESS computation tool for a serial multiple mediator model with a binary outcome variable (quitting vs. smoking).||6.32|0.34|0.02
74084143|NCT00216060|147721445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.08||||0.3|TWO_SIDED|95.0|0.51|8.4|||Regression, Cox|||||8.40|0.51|0.3
74084144|NCT00216060|147721446|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||univariate analysis|||||||0.12
74084145|NCT00216060|147721448|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
74084146|NCT00216060|147721450|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
74084147|NCT00216060|147721451|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Kruskal-Wallis|||||||0.010
74084148|NCT00216060|147721452|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
74084149|NCT03702816|147721461|OTHER|Linear Regression||||||0.6|||||||Regression, Linear|F=0.308||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.60
74084150|NCT03702816|147721461|OTHER|Linear Regression||||||0.56|||||||Regression, Linear|F=0.367||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.56
74084151|NCT03702816|147721461|OTHER|Linear regression||||||0.44|||||||Regression, Linear|||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.44
74084152|NCT03702816|147721461|OTHER|Linear Regression||||||0.15|||||||Regression, Linear|F=2.55||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.15
74084153|NCT03702816|147721461|OTHER|Linear Regression||||||0.39|||||||Regression, Linear|F=0.947||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.39
73840024|NCT01703221|147228135|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-0.8|||<|0.001|TWO_SIDED|95.0|-0.96|-0.63|||Constrained longitudinal analysis|Terms for treatment, prior oral antihyperglycemic agent (AHA), time, time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-0.63|-0.96|<0.001
73840025|NCT01703221|147228135|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-0.78|||<|0.001|TWO_SIDED|95.0|-0.94|-0.61|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-0.61|-0.94|<0.001
73840026|NCT01703221|147228135|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Omarigliptin will be considered non-inferior to sitagliptin if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in least squares means for change from baseline in HbA1c at Week 24 (omarigliptin minus sitagliptin) is not more than 0.3% (non-inferiority margin).|Difference in the least squares means|-0.02||||0.792|TWO_SIDED|95.0|-0.15|0.12|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||0.12|-0.15|0.792
73840027|NCT01703221|147228140|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-36.89|||<|0.001|TWO_SIDED|95.0|-48.46|-25.33|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-25.33|-48.46|<0.001
73840028|NCT01703221|147228140|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-39.76|||<|0.001|TWO_SIDED|95.0|-51.28|-28.23|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-28.23|-51.28|<0.001
73840029|NCT01703221|147228140|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|2.86||||0.555|TWO_SIDED|95.0|-6.67|12.39|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||12.39|-6.67|0.555
73840030|NCT01703221|147228141|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-12.28|||<|0.001|TWO_SIDED|95.0|-17.78|-6.78|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-6.78|-17.78|<0.001
73840031|NCT01703221|147228141|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-14.51|||<|0.001|TWO_SIDED|95.0|-20.04|-8.98|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-8.98|-20.04|<0.001
73840032|NCT01703221|147228141|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|2.23||||0.33|TWO_SIDED|95.0|-2.27|6.73|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||6.73|-2.27|0.330
73840033|NCT00834587|147228178|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|92.4|106.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.2|92.4|
73840034|NCT00834587|147228179|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.7||||||90.0|98.8|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.6|98.8|
73959748|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.8934|ONE_SIDED|95.0|-1.41||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.41|0.8934
73959749|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.47||0.5283|ONE_SIDED|95.0|-0.82||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.82|0.5283
73959750|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.41||0.49|ONE_SIDED|95.0|-0.68||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.68|0.4900
73959751|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.51||0.7465|ONE_SIDED|95.0|-1.2||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.20|0.7465
73959752|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.51||0.5848|ONE_SIDED|95.0|-0.95||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.95|0.5848
73959753|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.44||0.3178|ONE_SIDED|95.0|-0.53||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.53|0.3178
73959754|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.52||0.8169|ONE_SIDED|95.0|-1.34||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.34|0.8169
74022253|NCT01431287|147597090|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.611|TWO_SIDED|95.0|-0.019|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.032|-0.019|0.6110
74084154|NCT03702816|147721461|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.004||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.95
73840035|NCT00834587|147228180|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.6||||||90.0|98.8|102.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.5|98.8|
73840036|NCT00834587|147228181|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.7||||||90.0|97.3|106.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.3|97.3|
73840037|NCT00834587|147228182|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.2||||||90.0|96.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.0|96.5|
73840038|NCT00834587|147228183|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|96.5|101.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.8|96.5|
74022254|NCT01431287|147597091|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.059|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.111|0.059|<0.0001
74022255|NCT01431287|147597091|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.025|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.076|0.025|0.0001
74022256|NCT01431287|147597091|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.102|0.051|<0.0001
74022257|NCT01431287|147597091|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.044|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.095|0.044|<0.0001
74022258|NCT01431287|147597091|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.013||0.0013|TWO_SIDED|95.0|0.016|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.068|0.016|0.0013
74022259|NCT01431287|147597091|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5274|TWO_SIDED|95.0|-0.017|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.034|-0.017|0.5274
74022260|NCT01431287|147597091|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.078|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.052|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.103|0.052|<0.0001
74022261|NCT01431287|147597091|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.035|STANDARD_ERROR_OF_MEAN|0.013||0.0083|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.060|0.009|0.0083
74022262|NCT01431287|147597091|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.5744|TWO_SIDED|95.0|-0.018|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.033|-0.018|0.5744
74022263|NCT01431287|147597091|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0381|TWO_SIDED|95.0|0.001|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.053|0.001|0.0381
74022264|NCT01431287|147597092|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.081|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.055|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.108|0.055|<0.0001
74022265|NCT01431287|147597092|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.053|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.027|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.079|0.027|<0.0001
73840039|NCT00530257|147228219|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||We used a Bonferroni correct to adjust for up to 5 measures across domains and use a p-value of \<=0.01. With a sample of 30 subjects the analytic model was able to detect a difference of large effect size (Cohen's d= \>0.655)|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.||||<0.01
73840040|NCT00530257|147228220|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch Walk, Don't Walk||||<0.01
73840041|NCT00530257|147228221|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||This p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.||||<0.05
73840042|NCT00530257|147228223|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||We did not correct for multiple comparisons|t-test, 2 sided|We used a paired t-test||A paired t-test was used to compare the medication versus placebo.||||<0.05
73840043|NCT00530257|147228225|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk.|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
73840044|NCT00530257|147228226|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The p value adjusts for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||<0.01
73840045|NCT00530257|147228227|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
73840046|NCT00530257|147228228|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
73840047|NCT00530257|147228229|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
74084155|NCT03702816|147721461|OTHER|Linear Regulation||||||0.53|||||||Regression, Linear|F=0.483||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.53
73840048|NCT00530257|147228230|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
73840049|NCT01500135|147228296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62|STANDARD_ERROR_OF_MEAN|0.72||0.276|TWO_SIDED|95.0|0.68|3.88||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic|||||3.88|0.68|0.276
73840050|NCT01500135|147228297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.33||0.684|TWO_SIDED|95.0|0.4|1.82||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic|||||1.82|0.40|0.684
73840051|NCT01500135|147228298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|STANDARD_ERROR_OF_MEAN|0.24||0.684|TWO_SIDED|95.0|0.7|1.8||P-value was adjusted using Hochberg's adjustment for multiplicity.|Proportional Hazard Model|||||1.8|0.7|0.684
73840052|NCT01879826|147228300|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance||||||0.044|||||||t-test, 2 sided|||||||0.044
73840053|NCT01879826|147228301|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance.||||||0.04|||||||t-test, 2 sided|||||||0.04
73840054|NCT02003898|147228302|NON_INFERIORITY|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.034|||||TWO_SIDED|95.0|-0.03|0.098||||||||0.098|-0.03|
73840055|NCT03766906|147228370|SUPERIORITY||Mean Difference (Final Values)|2.03||||0.003|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pretest to posttest change was significantly greater than 0 at P \< 0.05.|||||.003
73840056|NCT03766906|147228371|SUPERIORITY||Mean Difference (Final Values)|1.18||||0.022|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than zero at P\<0.05.|||||.022
73840057|NCT03766906|147228372|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.016|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.016
73840058|NCT03766906|147228373|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.002|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.002
73840059|NCT03766906|147228374|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.626|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.626
73840060|NCT03766906|147228374|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.909|TWO_SIDED||||||t-test, 2 sided|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.||The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.909
73898486|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.427||0.926|TWO_SIDED|95.0|-0.799|0.878||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.878|-0.799|0.926
73840061|NCT03766906|147228374|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.905|TWO_SIDED||||||t-test, 2 sided||Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.905
73840062|NCT03766906|147228375|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.054|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.054
73840063|NCT03766906|147228376|SUPERIORITY||Mean Difference (Final Values)|3.48|||<|0.001|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||<.001
73840064|NCT03766906|147228377|SUPERIORITY||Mean Difference (Final Values)|7.52|||<|0.001|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||<.001
73840065|NCT03533491|147228395|EQUIVALENCE|A test of the null hypothesis that the proportion of participants from pretest to posttest change is equal to zero.|Proportion Difference|0.07|STANDARD_ERROR_OF_MEAN|0.044||0.044|TWO_SIDED||||||t-test, 2 sided||A paired t-test that evaluates whether significant pretest to posttest change in the proportion of users is different from zero.|||||.044
73840066|NCT03533491|147228396|EQUIVALENCE|A test of the null hypothesis that the proportion who use from pretest to posttest is equal to zero.|Proportion Difference|0.035|STANDARD_ERROR_OF_MEAN|0.056||0.532|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether the proportion who use from pretest to posttest change is different from zero.||||||.532
73840067|NCT03533491|147228397|EQUIVALENCE|A test of the null hypothesis that the proportion of participants who use from pretest to posttest is equal to zero.|Proportion Difference|-0.053|STANDARD_ERROR_OF_MEAN|0.058||0.37|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.370
73840068|NCT03533491|147228398|EQUIVALENCE|A test of the null hypothesis that the proportion of participants that use from pretest to posttest is equal to zero.|Proportion Difference|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.02|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether proportion who use from pretest to posttest is different from zero.||||||.020
73840069|NCT03533491|147228399|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.108||0.773|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.773
73840070|NCT03533491|147228400|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.08||0.978|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.978
74022266|NCT01431287|147597092|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.091|0.039|<0.0001
73840071|NCT03533491|147228401|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.089||0.745|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.745
73840072|NCT03533491|147228402|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.154|STANDARD_ERROR_OF_MEAN|0.101||0.132|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.132
73840073|NCT03533491|147228403|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.111||0.551|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.551
73959755|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.51||0.6727|ONE_SIDED|95.0|-1.08||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.08|0.6727
73959756|NCT00430300|147454780|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.45||0.5014|ONE_SIDED|95.0|-0.75||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.75|0.5014
74084156|NCT03702816|147721461|OTHER|Linear Regression||||||0.19|||||||Regression, Linear|F=2.543||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.19
73840074|NCT03533491|147228404|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.255||0.255|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.255
73840075|NCT03533491|147228405|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|||||||A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||
73840076|NCT03533491|147228406|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.091||0.198|TWO_SIDED||||||t-test, 2 sided|||||||.198
73840077|NCT03533491|147228407|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.121||0.77|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.770
73840078|NCT03533491|147228408|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.137||0.834|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.834
73840079|NCT03533491|147228409|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.096|STANDARD_ERROR_OF_MEAN|0.07||0.175|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.175
73840080|NCT01725282|147228414|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-3.1|3.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||3.6|-3.1|
73840081|NCT01725282|147228414|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-4.0|2.8|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||2.8|-4.0|
73840082|NCT01725282|147228414|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-2.1|4.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||4.6|-2.1|
73840083|NCT05263791|147228423|NON_INFERIORITY|The primary objective to prove the non-inferiority in between the Airmod and reference device is determined by the difference between AirRR and ManCRR.|||||<|0.001|||||||Paired t Test|||Hypothesis: airRR-mancRR ≦ -3, In the target of p\<0.05 indicates significance.||||<0.001
73840084|NCT05263791|147228424|NON_INFERIORITY|The hypothesis tested is demonstrated airRR non-inferior to acoRR when the capnostream is less sensitive.|||||<|0.001|||||||Paired t Test|||"In this study, a non-inferiority test was conducted during periods of reduced sensitivity in capnography to compare respiratory rate measurements using the Airmod device (airRR) versus manually scored auscultation sounds (referred to as acoRR, implying manARR in the statistical analysis plan). The research physician identified periods of reduced sensitivity in capnography."||||<0.001
73840085|NCT05263791|147228426|SUPERIORITY|This analysis were examined to assess the responsiveness of Airmod and Capnography.|||||<|0.001|||||||Paired t Test|||The hypothesis tested whether the response times obtained with the Airmod device were equal to those recorded with Capnography.||||<0.001
73840086|NCT05263791|147228427|NON_INFERIORITY|The objective to prove the non-inferiority in between the Airmod and reference device is determined by the difference between AirRR and ManCRR by subjects.|||||<|0.05|||||||Paired t Test|||Hypothesis: airRR-mancRR ≦ -2, In the target of p\<0.05 indicates significance.||||<0.05
73840087|NCT04576481|147228431|SUPERIORITY||F-Statistic|1.18||||0.32|TWO_SIDED||||||ANOVA|||Analysis of Variance statistical testing.||||0.32
73840088|NCT04576481|147228432|SUPERIORITY||F-Statistic|0.25||||0.78|TWO_SIDED||||||ANOVA|||||||0.78
73840089|NCT04576481|147228433|SUPERIORITY|||||||0.19|||||||ANOVA|||||||0.19
74084157|NCT03702816|147721461|OTHER|Linear Regression||||||0.32|||||||Regression, Linear|F=3.430||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.32
73840090|NCT04576481|147228434|SUPERIORITY|||||||0.46|||||||ANOVA|||||||0.46
73840091|NCT04576481|147228435|SUPERIORITY|||||||0.3|||||||ANOVA|||||||0.30
73840092|NCT02034565|147228443|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.977|||||TWO_SIDED|90.0|0.756|1.261||||||||1.261|0.756|
73840093|NCT02034565|147228444|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.05|||||TWO_SIDED|90.0|0.938|1.176||||||||1.176|0.938|
73840094|NCT02034565|147228445|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.043|||||TWO_SIDED|90.0|0.933|1.167||||||||1.167|0.933|
73840095|NCT00967486|147228500|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
73840096|NCT00489476|147228546|SUPERIORITY|||||||0.0212|||||||Fisher Exact|||||||0.0212
73840097|NCT00489476|147228546|SUPERIORITY|||||||0.0106|||||||Fisher Exact|||||||0.0106
73840098|NCT00489476|147228547|SUPERIORITY|||||||0.0123|||||||Fisher Exact|||||||0.0123
73840099|NCT00489476|147228547|SUPERIORITY|||||||0.0228|||||||Fisher Exact|||||||0.0228
73840100|NCT00489476|147228548|SUPERIORITY|||||||0.0409|||||||Fisher Exact|||||||0.0409
73840101|NCT00803049|147228550|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.824||||0.2079|TWO_SIDED|95.0|0.602|1.128||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.128|0.602|0.2079
73840102|NCT00803049|147228550|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.3039|TWO_SIDED|95.0|0.591|1.152||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs.Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.152|0.591|0.3039
73840103|NCT00803049|147228550|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.8271|TWO_SIDED|95.0|0.736|1.26||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.260|0.736|0.8271
73840104|NCT00803049|147228551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.961||||0.8017|TWO_SIDED|95.0|0.678|1.362||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.362|0.678|0.8017
73840105|NCT00803049|147228551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.1866|TWO_SIDED|95.0|0.559|1.117||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.117|0.559|0.1866
73840106|NCT00803049|147228551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8763|TWO_SIDED|95.0|0.767|1.357||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.357|0.767|0.8763
73840107|NCT04439903|147228627|OTHER||Intercept|1.9726|STANDARD_ERROR_OF_MEAN|3.8238||0.61532|TWO_SIDED||||||Regression, Linear|||||||0.61532
73840108|NCT04439903|147228627|OTHER||Slope|-0.68016|STANDARD_ERROR_OF_MEAN|1.0084||0.5128|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.5128
73840109|NCT04439903|147228627|OTHER||Slope|0.15238|STANDARD_ERROR_OF_MEAN|0.3629||0.68197|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.68197
73840110|NCT04439903|147228628|OTHER||Intercept|-0.49527|STANDARD_ERROR_OF_MEAN|0.44535||0.28789|TWO_SIDED||||||Regression, Linear|||||||0.28789
73840111|NCT04439903|147228628|OTHER||Slope|0.16785|STANDARD_ERROR_OF_MEAN|0.11745||0.17848|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.17848
73840112|NCT04439903|147228628|OTHER||Slope|-0.06091|STANDARD_ERROR_OF_MEAN|0.042266||0.17514|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.17514
73840113|NCT04439903|147228629|OTHER||Intercept|-0.28825|STANDARD_ERROR_OF_MEAN|0.59949||0.63929|TWO_SIDED||||||Regression, Linear|||||||0.63929
73840114|NCT04439903|147228629|OTHER||Slope|-0.14422|STANDARD_ERROR_OF_MEAN|0.1581||0.37964|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.37964
73840115|NCT04439903|147228629|OTHER||Slope|0.06718|STANDARD_ERROR_OF_MEAN|0.056895||0.26057|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.26057
73840116|NCT04003142|147228630|SUPERIORITY|Least squares Mean (LSM), Standard error (SE), Confidence interval (CI), Mixed model repeated measures (MMRM), Change from Baseline (CFB), Dependent variable (dv), Treatment (tr), Week (wk), Baseline (bl), Weight (wt)|Least squares (LS) Mean difference|-1.82|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-2.73|-0.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.91|-2.73|<0.001
74022267|NCT01431287|147597092|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.055|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.029|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.081|0.029|<0.0001
74084158|NCT03702816|147721461|OTHER|Linear Regression||||||0.11|||||||Regression, Linear|F=32.844||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.11
73840117|NCT04003142|147228630|SUPERIORITY||LSMean difference|-2.55|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-3.45|-1.64||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.64|-3.45|<0.001
74084159|NCT03702816|147721461|OTHER|Linear Regression||||||0.31|||||||Regression, Linear|F=3.559||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.31
74084160|NCT03702816|147721461|OTHER|Linear Regression||||||0.005|||||||Regression, Linear|F=14362.699||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.005
73840118|NCT04003142|147228630|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
73840119|NCT04003142|147228630|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
73840120|NCT04003142|147228631|SUPERIORITY||LSMean Difference|-1.86|STANDARD_ERROR_OF_MEAN|0.55|<|0.001||95.0|-2.94|-0.78||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.78|-2.94|<0.001
73840121|NCT04003142|147228631|SUPERIORITY||LSMean difference|-2.53|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.6|-1.46||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.46|-3.60|<0.001
73840122|NCT04003142|147228631|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
73840123|NCT04003142|147228631|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
73840124|NCT04003142|147228632|SUPERIORITY||LSMean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.021||95.0|-0.27|-0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.02|-0.27|0.021
73840125|NCT04003142|147228632|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.001||95.0|-0.41|-0.16||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.16|-0.41|<0.001
73840126|NCT04003142|147228632|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
73840127|NCT04003142|147228632|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
73840128|NCT04003142|147228633|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.049||95.0|-0.33|0.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.00|-0.33|0.049
73840129|NCT04003142|147228633|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.45|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.13|-0.45|<0.001
73840130|NCT04003142|147228633|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
73840131|NCT04003142|147228633|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
73840132|NCT04003142|147228634|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.7||0.381|TWO_SIDED|95.0|-2.1|0.8||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.8|-2.1|0.381
73840133|NCT04003142|147228634|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.007|TWO_SIDED|95.0|-3.5|-0.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.6|-3.5|0.007
73840134|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.09|-0.51||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.51|-2.09|0.001
74022268|NCT01431287|147597092|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.013||0.0052|TWO_SIDED|95.0|0.011|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|0.011|0.0052
74022269|NCT01431287|147597092|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.013||0.2273|TWO_SIDED|95.0|-0.01|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.042|-0.010|0.2273
74022270|NCT01431287|147597092|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.045|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|0.045|<0.0001
74022271|NCT01431287|147597092|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.013||0.033|TWO_SIDED|95.0|0.002|0.055||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.055|0.002|0.0330
74084161|NCT03702816|147721461|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.056||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.84
74084162|NCT03702816|147721461|OTHER|Linear Regression||||||0.94|||||||Regression, Linear|F=0.008||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.94
74084163|NCT03702816|147721461|OTHER|Linear Regression||||||0.29|||||||Regression, Linear|F=2.01||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.29
74022272|NCT01431287|147597092|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.4327|TWO_SIDED|95.0|-0.016|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.037|-0.016|0.4327
74022273|NCT01431287|147597092|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.013||0.1764|TWO_SIDED|95.0|-0.008|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.044|-0.008|0.1764
74084164|NCT03702816|147721461|OTHER|Linear Regression||||||0.72|||||||Regression, Linear|F=0.173||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.72
74084165|NCT03702816|147721462|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.424||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.54
74084166|NCT03702816|147721462|OTHER|Linear Regression||||||0.53|||||||Regression, Linear|F=0.447||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.53
74084167|NCT03702816|147721462|OTHER|Linear Regression||||||0.23|||||||Regression, Linear|F=1.773||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.23
74084168|NCT03702816|147721462|OTHER|Linear Regression||||||0.01|||||||Regression, Linear|F=3.615||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.01
74084169|NCT03702816|147721462|OTHER|Linear Regression||||||0.039|||||||Regression, Linear|F=9.204||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.039
74084170|NCT03702816|147721462|OTHER|Linear Regression||||||0.33|||||||Regression, Linear|F=1.209||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.33
74084171|NCT03702816|147721462|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=5.801||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.07
74084172|NCT03702816|147721462|OTHER|Linear Regression||||||0.03|||||||Regression, Linear|F=10.374||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.03
74084173|NCT03702816|147721462|OTHER|Linear Regression||||||0.27|||||||Regression, Linear|F=5.024||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.27
73840135|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.4|<|0.001||95.0|-2.51|-0.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.91|-2.51|<0.001
73840136|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|-2.65|-0.87||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.87|-2.65|<0.001
73840137|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|-2.86|-1.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.08|-2.86|<0.001
73840138|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-2.63|-0.84||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.84|-2.63|<0.001
73840139|NCT04003142|147228635|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-3.29|-1.5||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.50|-3.29|<0.001
73840140|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.84|STANDARD_ERROR_OF_MEAN|0.48|<|0.001||95.0|-2.79|-0.9||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.90|-2.79|<0.001
73840141|NCT04003142|147228635|SUPERIORITY||LSMean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.61|-1.72||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.72|-3.61|<0.001
73840142|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.78|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-2.71|-0.85||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.85|-2.71|<0.001
73840143|NCT04003142|147228635|SUPERIORITY||LSMean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.47|<|0.001||95.0|-3.59|-1.73||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.73|-3.59|<0.001
73840144|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.49|<|0.001||95.0|-2.77|-0.83||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.83|-2.77|<0.001
73840145|NCT04003142|147228635|SUPERIORITY||LSMean difference|-2.34|STANDARD_ERROR_OF_MEAN|0.49|<|0.001||95.0|-3.3|-1.37||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.37|-3.30|<0.001
73840146|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.79|-0.74||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.74|-2.79|<0.001
73959757|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|6.3||0.7292|ONE_SIDED|95.0|-14.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-14.3|0.7292
73840147|NCT04003142|147228635|SUPERIORITY||LSMean difference|-2.38|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-3.4|-1.35||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.35|-3.40|<0.001
73840148|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.65|STANDARD_ERROR_OF_MEAN|0.54||0.002||95.0|-2.71|-0.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.59|-2.71|0.002
73840149|NCT04003142|147228635|SUPERIORITY||LSMean difference|-2.51|STANDARD_ERROR_OF_MEAN|0.54|<|0.001||95.0|-3.57|-1.45||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.45|-3.57|<0.001
73840150|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.91|STANDARD_ERROR_OF_MEAN|0.54|<|0.001||95.0|-2.96|-0.86||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.86|-2.96|<0.001
73840151|NCT04003142|147228635|SUPERIORITY||LSMean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.53|<|0.001||95.0|-3.69|-1.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.60|-3.69|<0.001
73898487|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|3.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74084174|NCT03702816|147721462|OTHER|Linear Regression||||||0.16|||||||Regression, Linear|F=15.568||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.16
73959758|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|6.2||0.2768|ONE_SIDED|95.0|-6.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-6.6|0.2768
73840152|NCT04003142|147228635|SUPERIORITY||LSMean difference|-1.86|STANDARD_ERROR_OF_MEAN|0.53|<|0.001||95.0|-2.91|-0.81||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.81|-2.91|<0.001
73840153|NCT04003142|147228635|SUPERIORITY||LSMean difference|-2.56|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|-3.61|-1.52||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.52|-3.61|<0.001
73840154|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.001||95.0|-0.21|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.05|-0.21|0.001
73840155|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.24|-0.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.08|-0.24|<0.001
73840156|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001||95.0|-0.28|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.07|-0.28|0.001
73840157|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.28|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.07|-0.28|0.001
73840158|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.067||95.0|-0.23|0.01||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||0.01|-0.23|0.067
73840159|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.35|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.11|-0.35|<0.001
73840160|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.02|TWO_SIDED|95.0|-0.3|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.03|-0.30|0.020
73840161|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.16||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.16|-0.43|<0.001
73840162|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.012|TWO_SIDED|95.0|-0.32|-0.04||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.04|-0.32|0.012
73840163|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001||95.0|-0.42|-0.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.14|-0.42|<0.001
73840164|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.03|TWO_SIDED|95.0|-0.31|-0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.02|-0.31|0.030
73840165|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.14|-0.43|<0.001
74084175|NCT03702816|147721462|OTHER|Linear Regression||||||0.262|||||||Regression, Linear|F=5.238||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.262
73840166|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.095|TWO_SIDED|95.0|-0.28|0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||0.02|-0.28|0.095
73840167|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.41|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.11|-0.41|<0.001
73840168|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.109|TWO_SIDED|95.0|-0.28|0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||0.03|-0.28|0.109
74084176|NCT03702816|147721462|OTHER|Linear Regression||||||0.043|||||||Regression, Linear|F=221.308||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.043
74084177|NCT03702816|147721462|OTHER|Linear Regression||||||0.26|||||||Regression, Linear|F=2.430||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.26
73840169|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.12|-0.43|<0.001
73840170|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.02||95.0|-0.35|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.03|-0.35|0.020
73840171|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.47|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.15|-0.47|<0.001
73840172|NCT04003142|147228636|SUPERIORITY||LSMean diferrence|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012||95.0|-0.37|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.05|-0.37|0.012
73840173|NCT04003142|147228636|SUPERIORITY||LSMean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.47|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.15|-0.47|<0.001
73840174|NCT04003142|147228637|SUPERIORITY||LSMean difference|-12.16|STANDARD_ERROR_OF_MEAN|3.43|<|0.001||95.0|-18.9|-5.43||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-5.43|-18.90|<0.001
73840175|NCT04003142|147228637|SUPERIORITY||LSMean difference|-15.68|STANDARD_ERROR_OF_MEAN|3.44|<|0.001||95.0|-22.44|-8.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-8.91|-22.44|<0.001
73840176|NCT04003142|147228637|SUPERIORITY||LSMean difference|-14.61|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-22.09|-7.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-7.13|-22.09|<0.001
73840177|NCT04003142|147228637|SUPERIORITY||LSMean difference|-15.95|STANDARD_ERROR_OF_MEAN|3.82|<|0.001|TWO_SIDED|95.0|-23.45|-8.45||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-8.45|-23.45|<0.001
73840178|NCT04003142|147228637|SUPERIORITY||LSMean difference|-15.51|STANDARD_ERROR_OF_MEAN|3.89|<|0.001||95.0|-23.16|-7.86||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-7.86|-23.16|<0.001
73840179|NCT04003142|147228637|SUPERIORITY||LSMean difference|-20.25|STANDARD_ERROR_OF_MEAN|3.9|<|0.001||95.0|-27.91|-12.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-12.59|-27.91|<0.001
73840180|NCT04003142|147228637|SUPERIORITY||LSMean difference|-16.34|STANDARD_ERROR_OF_MEAN|3.92|<|0.001||95.0|-24.04|-8.63||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-8.63|-24.04|<0.001
73840181|NCT04003142|147228637|SUPERIORITY||LSMean difference|-21.65|STANDARD_ERROR_OF_MEAN|3.92|<|0.001||95.0|-29.36|-13.94||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-13.94|-29.36|<0.001
73840182|NCT04003142|147228637|SUPERIORITY||LSMean difference|-15.62|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-23.27|-7.98||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-7.98|-23.27|<0.001
73840183|NCT04003142|147228637|SUPERIORITY||LSMean difference|-22.88|STANDARD_ERROR_OF_MEAN|3.89|<|0.001||95.0|-30.52|-15.24||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-15.24|-30.52|<0.001
73840184|NCT04003142|147228637|SUPERIORITY||LSMean difference|-14.78|STANDARD_ERROR_OF_MEAN|3.87|<|0.001||95.0|-22.38|-7.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-7.19|-22.38|<0.001
73840185|NCT04003142|147228637|SUPERIORITY||LSMean difference|-22.66|STANDARD_ERROR_OF_MEAN|3.86|<|0.001|TWO_SIDED|95.0|-30.25|-15.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-15.07|-30.25|<0.001
74084178|NCT03702816|147721462|OTHER|Linear Regression||||||0.38|||||||Regression, Linear|F=1.269||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.38
73840186|NCT04003142|147228637|SUPERIORITY||LSMean difference|-14.97|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-22.86|-7.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-7.09|-22.86|<0.001
73840187|NCT04003142|147228637|SUPERIORITY||LSMean difference|-21.47|STANDARD_ERROR_OF_MEAN|4.01|<|0.001||95.0|-29.34|-13.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-13.60|-29.34|<0.001
73840188|NCT04003142|147228637|SUPERIORITY||LSMean difference|-14.38|STANDARD_ERROR_OF_MEAN|4.05|<|0.001|TWO_SIDED|95.0|-22.33|-6.43||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-6.43|-22.33|<0.001
73840189|NCT04003142|147228637|SUPERIORITY||LSMean difference|-20.57|STANDARD_ERROR_OF_MEAN|4.03|<|0.001||95.0|-28.5|-12.65||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-12.65|-28.50|<0.001
73840190|NCT04003142|147228637|SUPERIORITY||LSMean difference|-12.14|STANDARD_ERROR_OF_MEAN|4.07||0.003||95.0|-20.14|-4.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-4.14|-20.14|0.003
73840191|NCT04003142|147228637|SUPERIORITY||LSMean difference|-19.73|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-27.71|-11.755||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-11.755|-27.71|<0.001
73840192|NCT04003142|147228637|SUPERIORITY||LSMean difference|-14.4|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-22.25|-6.54||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-6.54|-22.25|<0.001
73840193|NCT04003142|147228637|SUPERIORITY||LSMean difference|-20.1|STANDARD_ERROR_OF_MEAN|3.98|<|0.001||95.0|-27.93|-12.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-12.27|-27.93|<0.001
73840194|NCT04003142|147228637|SUPERIORITY||LSMean difference|-14.96|STANDARD_ERROR_OF_MEAN|4.07|<|0.001||95.0|-22.96|-6.96||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-6.96|-22.96|<0.001
73840195|NCT04003142|147228637|SUPERIORITY||LSMean difference|-20.15|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.13|-12.18||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-12.18|-28.13|<0.001
73840196|NCT04003142|147228637|SUPERIORITY||LSMean difference|-13.64|STANDARD_ERROR_OF_MEAN|4.07|<|0.001||95.0|-21.62|-5.65||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-5.65|-21.62|<0.001
73840197|NCT04003142|147228637|SUPERIORITY||LSMean difference|-18.94|STANDARD_ERROR_OF_MEAN|4.05|<|0.001||95.0|-26.89|-10.98||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-10.98|-26.89|<0.001
73959759|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.4||0.3795|ONE_SIDED|95.0|-7.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-7.4|0.3795
73959760|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|7.7||0.7374|ONE_SIDED|95.0|-17.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-17.7|0.7374
73840198|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|1.881||||0.02||95.0|1.11|3.233||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||3.233|1.110|0.020
73959761|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.6||0.7615|ONE_SIDED|95.0|-18.1||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-18.1|0.7615
73959762|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|6.6||0.5811|ONE_SIDED|95.0|-12.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.4|0.5811
73959763|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|8.6||0.8939|ONE_SIDED|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-25.3|0.8939
74084179|NCT03702816|147721462|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=13.164||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.07
73840199|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.645|||<|0.001|TWO_SIDED|95.0|1.585|4.498||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||4.498|1.585|<0.001
73840200|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.464|||<|0.001||95.0|1.535|4.001||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.001|1.535|<0.001
73840201|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.464|||<|0.001|TWO_SIDED|95.0|1.534|4.004||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.004|1.534|<0.001
73840202|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.367|||<|0.001||95.0|1.502|3.762||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.762|1.502|<0.001
73840203|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.894|||<|0.001||95.0|1.835|4.609||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||4.609|1.835|<0.001
73840204|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.902|||<|0.001|TWO_SIDED|95.0|1.829|4.657||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.657|1.829|<0.001
73840205|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|3.218|||<|0.001||95.0|2.025|5.172||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||5.172|2.025|<0.001
73840206|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.153|||<|0.001||95.0|1.375|3.394||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||3.394|1.375|<0.001
73840207|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|3.074|||<|0.001||95.0|1.957|4.878||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||4.878|1.957|<0.001
73840208|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.05||||0.002||95.0|1.31|3.228||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.228|1.310|0.002
73840209|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.908|||<|0.001||95.0|1.856|4.599||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.599|1.856|<0.001
73840210|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.113||||0.001||95.0|1.349|3.332||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.332|1.349|0.001
73840211|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.594|||<|0.001||95.0|1.653|4.104||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||4.104|1.653|<0.001
73840212|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|1.891||||0.005|TWO_SIDED|95.0|1.21|2.973||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||2.973|1.210|0.005
73840213|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|3.314|||<|0.001||95.0|2.108|5.265||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||5.265|2.108|<0.001
73840214|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|1.646||||0.027||95.0|1.06|2.566||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||2.566|1.060|0.027
73840215|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.347|||<|0.001||95.0|1.507|3.683||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.683|1.507|<0.001
73840216|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|1.792||||0.01|TWO_SIDED|95.0|1.153|2.799||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||2.799|1.153|0.010
73840217|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.819|||<|0.001||95.0|1.805|4.441||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||4.441|1.805|<0.001
73959764|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.4||0.8117|ONE_SIDED|95.0|-21.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.6|0.8117
73840218|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.357|||<|0.001||95.0|1.513|3.699||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.699|1.513|<0.001
73959765|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|7.4||0.4393|ONE_SIDED|95.0|-11.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.2|0.4393
73840219|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|3.131|||<|0.001||95.0|1.999|4.95||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.950|1.999|<0.001
73840220|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|1.373||||0.152||95.0|0.891|2.122||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||2.122|0.891|0.152
73840221|NCT04003142|147228638|SUPERIORITY||Odds Ratio (OR)|2.09|||<|0.001||95.0|1.351|3.252||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||3.252|1.351|<0.001
73840222|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|0.915||||0.951||95.0|0.036|23.464||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||23.464|0.036|0.951
73840223|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|2.889||||0.362|TWO_SIDED|95.0|0.364|58.864||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||58.864|0.364|0.362
73840224|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|2.775||||0.138||95.0|0.785|12.87||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||12.870|0.785|0.138
73840225|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|1.342||||0.704||95.0|0.291|6.914||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||6.914|0.291|0.704
73840226|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|0.798||||0.741||95.0|0.194|3.079||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.079|0.194|0.741
73840227|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|2.292||||0.134||95.0|0.809|7.443||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||7.443|0.809|0.134
73840228|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|3.474||||0.062||95.0|1.039|15.712||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||15.712|1.039|0.062
73840229|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|6.184||||0.004||95.0|2.025|26.875||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||26.875|2.025|0.004
73840230|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|4.217||||0.028|TWO_SIDED|95.0|1.305|18.806||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||18.806|1.305|0.028
73840231|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|3.802||||0.044||95.0|1.157|17.075||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||17.075|1.157|0.044
73840232|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|1.342||||0.519||95.0|0.551|3.382||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.382|0.551|0.519
73840233|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|1.961||||0.117||95.0|0.863|4.741||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.741|0.863|0.117
73840234|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|1.471||||0.393||95.0|0.612|3.687||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.687|0.612|0.393
74084180|NCT03702816|147721462|OTHER|Linear Regression||||||0.37|||||||Regression, Linear|F=1.312||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.37
73840235|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|2.087||||0.086||95.0|0.923|5.043||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||5.043|0.923|0.086
73840236|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|1.774||||0.168||95.0|0.798|4.143||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||4.143|0.798|0.168
73840237|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|2.374||||0.03||95.0|1.112|5.41||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||5.410|1.112|0.030
73840238|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|1.605||||0.287|TWO_SIDED|95.0|0.681|3.971||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.971|0.681|0.287
73840239|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|2.108||||0.08||95.0|0.936|5.076||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||5.076|0.936|0.080
73840240|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|1.599||||0.247|TWO_SIDED|95.0|0.73|3.636||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||3.636|0.730|0.247
74084181|NCT03702816|147721463|OTHER|Linear Regression||||||0.64|||||||Regression, Linear|F=0.233||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.64
74022274|NCT01431287|147597093|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.0241|TWO_SIDED|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.105|0.007|0.0241
74022275|NCT01431287|147597093|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.051|0.148||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.148|0.051|<0.0001
74022276|NCT01431287|147597093|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.025||0.0049|TWO_SIDED|95.0|0.021|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.119|0.021|0.0049
74022277|NCT01431287|147597093|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.147|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.196|0.098|<0.0001
74022278|NCT01431287|147597093|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.113|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.064|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.162|0.064|<0.0001
74022279|NCT01431287|147597093|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.025||0.5831|TWO_SIDED|95.0|-0.063|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.035|-0.063|0.5831
74022280|NCT01431287|147597093|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.133|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.182||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.182|0.084|<0.0001
74022281|NCT01431287|147597093|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.043|STANDARD_ERROR_OF_MEAN|0.025||0.0822|TWO_SIDED|95.0|-0.092|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.006|-0.092|0.0822
74022282|NCT01431287|147597093|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.077|STANDARD_ERROR_OF_MEAN|0.025||0.002|TWO_SIDED|95.0|-0.126|-0.028||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.028|-0.126|0.0020
74022283|NCT01431287|147597093|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.025||0.1774|TWO_SIDED|95.0|-0.015|0.083||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.083|-0.015|0.1774
74022284|NCT01431287|147597094|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.219|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.169|0.268||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.268|0.169|<0.0001
74022285|NCT01431287|147597094|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.143|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.193|0.094|<0.0001
73840241|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|2.481||||0.017||95.0|1.201|5.441||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||5.441|1.201|0.017
74022286|NCT01431287|147597094|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.209|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.16|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.258|0.160|<0.0001
74022287|NCT01431287|147597094|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.104|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.203|0.104|<0.0001
73840242|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|1.728||||0.212||95.0|0.744|4.236||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.236|0.744|0.212
73840243|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|3.536||||0.002||95.0|1.666|8.207||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||8.207|1.666|0.002
73840244|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|1.701||||0.225||95.0|0.733|4.169||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||4.169|0.733|0.225
73840245|NCT04003142|147228639|SUPERIORITY||Odds Ratio (OR)|3.049||||0.006||95.0|1.42|7.125||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||7.125|1.420|0.006
73840246|NCT03382873|147228661|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73840247|NCT03382873|147228662|SUPERIORITY|||||||0.0001|||||||ANOVA|Intervention sequence and sex were used as independent predictors in the model.||Compares the change for the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest)||||0.0001
73840248|NCT03382873|147228663|SUPERIORITY|||||||0.9476|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison of the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest).||||0.9476
73840249|NCT03382873|147228664|SUPERIORITY|||||||0.0112|||||||ANOVA|Treatment group, time and their interaction were fixed effects and participants were random effects||||||0.0112
73840250|NCT03382873|147228665|SUPERIORITY|||||||0.9085|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison of GLB/GLB intervention sequence to GLB+/GLB+ intervention sequence (the primary comparison of interest).||||0.9085
73840251|NCT03382873|147228666|SUPERIORITY|||||||0.2063|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison between the GLB/GLB intervention sequence and the GLB+/GLB+ intervention sequence (the primary comparison of interest)||||0.2063
73840252|NCT00907088|147228671|SUPERIORITY_OR_OTHER|||||||0.42|||||||Chi-squared|||||||0.42
73840253|NCT03109769|147228674|SUPERIORITY|||||||0.0444|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."||||0.0444
73840254|NCT03109769|147228674|SUPERIORITY||Mean Difference (Net)|-0.1373||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"|||||0.0002
73840255|NCT03109769|147228674|SUPERIORITY||Median Difference (Final Values)|0.0932||||0.0283|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"|||||0.0283
73840256|NCT03109769|147228675|SUPERIORITY|||||||0.0283|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."||||0.0283
73840257|NCT03109769|147228675|SUPERIORITY||Mean Difference (Net)|-0.1177||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"|||||0.0002
74084182|NCT03702816|147721463|OTHER|Linear Regression||||||0.92|||||||Regression, Linear|F=0.011||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.92
73840258|NCT03109769|147228675|SUPERIORITY||Mean Difference (Net)|0.1014||||0.4809|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"|||||0.4809
73840259|NCT02301793|147228676|OTHER||Odds Ratio (OR)|1.0||||0.05|TWO_SIDED|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.||||0.05
73840260|NCT02301793|147228680|OTHER||Odds Ratio (OR)|1.0||||0.05|TWO_SIDED|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.||||0.05
73840261|NCT04105725|147228683|SUPERIORITY||||||<|0.05|||||||negative binomial regression|||||||<0.05
73898488|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.423||0.553|TWO_SIDED|95.0|-1.082|0.58||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.580|-1.082|0.553
74084183|NCT03702816|147721463|OTHER|Linear Regression||||||0.22|||||||Regression, Linear|F=1.790||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.22
74084184|NCT03702816|147721463|OTHER|Linear Regression||||||0.42|||||||Regression, Linear|F=0.720||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.42
74084185|NCT03702816|147721463|OTHER|Linear Regression||||||0.61|||||||Regression, Linear|F=0.305||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.61
74084186|NCT03702816|147721463|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.005||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.95
74084187|NCT03702816|147721463|OTHER|Linear Regression||||||0.55|||||||Regression, Linear|F=0.435||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.55
74084188|NCT03702816|147721463|OTHER|Linear Regression||||||0.43|||||||Regression, Linear|F=0.787||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.43
74084189|NCT03702816|147721463|OTHER|Linear Regression||||||0.036|||||||Regression, Linear|F=316.379||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.036
74084190|NCT03702816|147721463|OTHER|Linear Regression||||||0.39|||||||Regression, Linear|F=2.032||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.39
74084191|NCT03702816|147721463|OTHER|Linear Regression||||||0.031|||||||Regression, Linear|F=425.337||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.031
74084192|NCT03702816|147721463|OTHER|Linear Regression||||||0.274|||||||Regression, Linear|F=4.739||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.274
74084193|NCT03702816|147721463|OTHER|Linear Regression||||||0.66|||||||Regression, Linear|F=0.263||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.66
74084194|NCT03702816|147721463|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=12.244||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.07
74084195|NCT03702816|147721463|OTHER|Linear Regression||||||0.48|||||||Regression, Linear|F=0.762||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.48
74084196|NCT03702816|147721463|OTHER|Linear Regression||||||0.12|||||||Regression, Linear|F=7.107||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.12
74084197|NCT03702816|147721464|OTHER|Linear Regression||||||0.85|||||||Regression, Linear|F=0.038||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.85
73840262|NCT00480025|147228694|SUPERIORITY|RMF included: 1) Number of chemotherapy cycles received (1, 2 vs. 3, 4), if any; 2) Pathological stage of the disease (IB vs. II vs. IIIA); 3) Type of lymph-node sampling (minimal lymph-node sampling vs. systematic radical mediastinal lymphadenectomy); 4) ECOG performance status randomization (0, 1 vs. 2); 5) Smoking status ( 100 cigarettes a lifetime vs. \> 100 cigarettes and current smoker vs. \>100 cigarettes and past smoker).|Treatment Efficacy|1.024||||0.7379|TWO_SIDED|95.0|0.891|1.177||2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.|Regression, Cox|Overall population objective reached if p-value \< 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.||Analysis compared DFS PYAR between groups for period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 Group (PYAR1) divided by PYAR in Placebo Group (PYAR2), and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account stratification by previous CT vs. No-CT treatment and weighing using randomization-minimization factors (RMF) as regressors.||1.177|0.891|0.7379
74084198|NCT03702816|147721464|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.042||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.84
74084199|NCT03702816|147721464|OTHER|Linear Regression||||||0.35|||||||Regression, Linear|F=1.021||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.35
74084200|NCT03702816|147721464|OTHER|Linear Regression||||||0.25|||||||Regression, Linear|F=1.610||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.25
74084201|NCT03702816|147721464|OTHER|Linear Regression||||||0.25|||||||Regression, Linear|F=1.779||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.25
74084202|NCT03702816|147721464|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.455||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.54
74084203|NCT03702816|147721464|OTHER|Linear Regression||||||0.47|||||||Regression, Linear|F=0.650||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.47
74084204|NCT03702816|147721464|OTHER|Linear Regression||||||0.74|||||||Regression, Linear|F=0.131||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.74
74084205|NCT03702816|147721464|OTHER|Linear Regression||||||0.83|||||||Regression, Linear|F=0.075||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.83
74084206|NCT03702816|147721464|OTHER|Linear Regression||||||0.41|||||||Regression, Linear|F=1.831||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.41
74084207|NCT03702816|147721464|OTHER|Linear Regression||||||0.83|||||||Regression, Linear|F=0.079||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.83
74084208|NCT03702816|147721464|OTHER|Linear Regression||||||0.52|||||||Regression, Linear|F=0.879||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.52
74084209|NCT03702816|147721464|OTHER|Linear Regression||||||0.98|||||||Regression, Linear|F=0.001||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.98
74084210|NCT03702816|147721464|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.005||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.95
74084211|NCT03702816|147721464|OTHER|Linear Regression||||||0.32|||||||Regression, Linear|F=1.733||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.32
74084212|NCT03702816|147721464|OTHER|Linear Regression||||||0.67|||||||Regression, Linear|F=0.249||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.67
74084213|NCT03702816|147721465|OTHER|Linear Regression||||||0.76|||||||Regression, Linear|F=0.098||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in Control Subjects||||0.76
73863167|NCT01073930|147272412|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|5.2|||||ONE_SIDED|97.5|0.4|||||||Recto-sigmoid colon comparison|||0.4|
73898489|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|3.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898490|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.432||0.69|TWO_SIDED|95.0|-1.021|0.677||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.677|-1.021|0.690
74022288|NCT01431287|147597094|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.134|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.183||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.183|0.084|<0.0001
74022289|NCT01431287|147597094|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.025||0.6974|TWO_SIDED|95.0|-0.04|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.059|-0.040|0.6974
74022290|NCT01431287|147597094|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.163|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.114|0.213||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.213|0.114|<0.0001
74022291|NCT01431287|147597094|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0027|TWO_SIDED|95.0|0.026|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.125|0.026|0.0027
74022292|NCT01431287|147597094|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.0269|TWO_SIDED|95.0|0.006|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.105|0.006|0.0269
74022293|NCT01431287|147597094|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.025||0.4343|TWO_SIDED|95.0|-0.03|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.069|-0.030|0.4343
74022294|NCT01431287|147597095|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.198|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.148|0.248||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.248|0.148|<0.0001
74022295|NCT01431287|147597095|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.146|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.096|0.197||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.197|0.096|<0.0001
74022296|NCT01431287|147597095|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.158|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.258|0.158|<0.0001
74022297|NCT01431287|147597095|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.193|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.143|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.242|0.143|<0.0001
74084214|NCT03702816|147721465|OTHER|Linear Regression||||||0.49|||||||Regression, Linear|F=0.513||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in Control Subjects||||0.49
74084215|NCT03702816|147721465|OTHER|Linear Regression||||||0.93|||||||Regression, Linear|F=0.008||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in MCI Subjects||||0.93
74084216|NCT03702816|147721465|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.430||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in MCI Subjects||||0.54
74084217|NCT03702816|147721465|OTHER|Linear Regression||||||0.77|||||||Regression, Linear|F=0.142||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in AD Subjects||||0.77
74084218|NCT03702816|147721465|OTHER|Linear Regression||||||0.61|||||||Regression, Linear|F=0.496||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in AD Subjects||||0.61
74084219|NCT03702816|147721465|OTHER|Linear Regression||||||0.11|||||||Regression, Linear|F=8.046||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in PD Subjects||||0.11
74022298|NCT01431287|147597095|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.106|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.206|0.106|<0.0001
74022299|NCT01431287|147597095|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.025||0.698|TWO_SIDED|95.0|-0.06|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.040|-0.060|0.6980
74022300|NCT01431287|147597095|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.233|0.132|<0.0001
74022301|NCT01431287|147597095|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.026||0.0442|TWO_SIDED|95.0|0.001|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.102|0.001|0.0442
74022302|NCT01431287|147597095|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.026||0.5514|TWO_SIDED|95.0|-0.035|0.065||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.065|-0.035|0.5514
74022303|NCT01431287|147597095|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.026||0.1569|TWO_SIDED|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.086|-0.014|0.1569
73840263|NCT00480025|147228695|SUPERIORITY|RMF taken into account included: 1) Number of chemotherapy cycles received (1, 2 vs. 3, 4), if any; 2) Pathological stage of the disease (IB vs. II vs. IIIA); 3) Type of lymph-node sampling (minimal lymph-node sampling vs. systematic radical mediastinal lymphadenectomy); 4) ECOG performance status randomization (0, 1 vs. 2); 5) Smoking status ( 100 cigarettes a lifetime vs. \> 100 cigarettes and current smoker vs. \> 100 cigarettes and past smoker).|Treatment Efficacy|0.97||||0.7572|TWO_SIDED|95.0|0.797|1.179||2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.|Regression, Cox|No-CT population objective reached if p-value \< 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.||Analysis compared DFS PYAR between groups for the period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 No-CT Group (PYAR1) divided by PYAR in Placebo No-CT Group (PYAR2) and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account weighing using randomization-minimization factors (RMF) as regressors.||1.179|0.797|0.7572
74022304|NCT01431287|147597096|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.202|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.15|0.253||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.253|0.150|<0.0001
74022305|NCT01431287|147597096|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.234|0.132|<0.0001
74022306|NCT01431287|147597096|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.218|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.167|0.269||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.269|0.167|<0.0001
74022307|NCT01431287|147597096|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.181|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.13|0.232||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day\^interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.232|0.130|<0.0001
74022308|NCT01431287|147597096|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.199|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.148|0.25||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.250|0.148|<0.0001
74022309|NCT01431287|147597096|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.016|STANDARD_ERROR_OF_MEAN|0.026||0.5373|TWO_SIDED|95.0|-0.067|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.035|-0.067|0.5373
73840264|NCT03726879|147228734|SUPERIORITY||Odds Ratio (OR)|0.67||||0.1846|TWO_SIDED|95.0|0.37|1.21||The threshold for statistical significance was a p-value =0.048|Cochran-Mantel-Haenszel|||||1.21|0.37|0.1846
73840265|NCT03726879|147228735|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9551|TWO_SIDED|95.0|0.67|1.46||The threshold for statistical significance was a p-value =0.002|Cochran-Mantel-Haenszel|||||1.46|0.67|0.9551
73840266|NCT03726879|147228738|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.59|||Log Rank|||All Participants||1.59|0.50|
73840267|NCT03726879|147228738|SUPERIORITY||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.65|4.32|||Log Rank|||PD-L1 IC1/2/3||4.32|0.65|
73840268|NCT03726879|147228738|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.27|1.22|||Log Rank|||PD-L1 IC0 Participants||1.22|0.27|
73840269|NCT03726879|147228738|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.58|2.82|||Log Rank|||ER/PgR Negative Participants||2.82|0.58|
73840270|NCT03726879|147228738|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.24|1.36|||Log Rank|||ER/PgR Positive Participants||1.36|0.24|
73840271|NCT03726879|147228739|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.38|1.32|||Log Rank|||All Participants||1.32|0.38|
73840272|NCT03726879|147228739|SUPERIORITY||Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.51|3.69|||Log Rank|||PD-L1 IC1/2/3||3.69|0.51|
73840273|NCT03726879|147228739|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.19|1.02|||Log Rank|||PD-L1 IC0||1.02|0.19|
73840274|NCT03726879|147228740|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.4|2.0|||Log Rank|||All Participants||2.00|0.40|
73840275|NCT03726879|147228740|SUPERIORITY||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.42|7.33|||Log Rank|||PD-L1 IC1/2/3||7.33|0.42|
73840276|NCT03726879|147228740|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.21|1.59|||Log Rank|||PD-L1 IC0||1.59|0.21|
73840277|NCT03726879|147228754|SUPERIORITY||Hazard Ratio (HR)|2.38|||||TWO_SIDED|95.0|0.22|26.42|||Regression, Cox|||PIK3CA-Missing||26.42|0.22|
73840278|NCT03726879|147228754|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.23|1.9|||Regression, Cox|||PIK3CA-Mutated||1.90|0.23|
73840279|NCT03726879|147228754|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.45|1.87|||Regression, Cox|||PIK3CA-Wildtype||1.87|0.45|
73840280|NCT03726879|147228755|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.07|18.91|||Regression, Cox|||PIK3CA-Missing||18.91|0.07|
73840281|NCT03726879|147228755|SUPERIORITY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.19|1.92||||||PIK3CA-Mutated||1.92|0.19|
73840282|NCT03726879|147228755|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.33|1.55|||Regression, Cox|||PIK3CA-Wildtype||1.55|0.33|
73840283|NCT03726879|147228756|SUPERIORITY||Hazard Ratio (HR)|999.99|||||TWO_SIDED|95.0|0.0||Upper limit of the CI was not evaluable due to low number of events||Regression, Cox||The estimated value is \>999.99|PIK3CA-Missing|||0.00|
73840284|NCT03726879|147228756|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.1|3.53|||Regression, Cox|||PIK3CA-Mutated||3.53|0.10|
73840285|NCT03726879|147228756|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.33|2.09|||Regression, Cox|||PIK3CA-Wildtype||2.09|0.33|
73840286|NCT03708770|147228775|OTHER|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Secondary Patency endpoint was calculated using a Kaplan-Meier analysis."|The Secondary Patency rate was determined via Kaplan-Meier methods.|||
73840287|NCT03708770|147228776|OTHER|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Primary Patency endpoint was calculated using a Kaplan-Meier analysis."|The primary patency rate was determined via Kaplan-Meier methods.|||
73840288|NCT01197300|147228785|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|3.7||||0.8505|TWO_SIDED|95.0|-37.242|44.642||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 18||44.642|-37.242|0.8505
73840289|NCT01197300|147228785|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|21.752||||0.218|TWO_SIDED|95.0|-14.126|57.63||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 24||57.630|-14.126|0.2180
73840290|NCT01197300|147228786|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|2.36||||0.3544|TWO_SIDED|95.0|-2.886|7.606||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 18||7.606|-2.886|0.3544
73840291|NCT01197300|147228786|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|1.179||||0.705|TWO_SIDED|95.0|-5.281|7.639||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 24||7.639|-5.281|0.7050
73840292|NCT01197300|147228787|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|121.129||||0.531|TWO_SIDED|95.0|-291.0|533.258||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 18||533.258|-291.000|0.5310
73840293|NCT01197300|147228787|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|65.674||||0.7347|TWO_SIDED|95.0|-344.067|475.415||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 24||475.415|-344.067|0.7347
73840294|NCT01197300|147228788|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-147.68||||0.4143|TWO_SIDED|95.0|-394.41|99.049||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 18||99.049|-394.410|0.4143
73840295|NCT01197300|147228788|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-132.437||||0.1266|TWO_SIDED|95.0|-286.452|21.579||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 24||21.579|-286.452|0.1266
73840296|NCT01197300|147228789|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-17.691||||0.2123|TWO_SIDED|95.0|-41.925|6.543||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 18||6.543|-41.925|0.2123
73840297|NCT01197300|147228789|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-3.662||||0.4852|TWO_SIDED|95.0|-21.479|14.155||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 24||14.155|-21.479|0.4852
73840298|NCT01197300|147228790|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-4.661||||0.9009|TWO_SIDED|95.0|-16.647|7.325||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 18||7.325|-16.647|0.9009
73840299|NCT01197300|147228790|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-2.558||||0.9472|TWO_SIDED|95.0|-8.864|3.747||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 24||3.747|-8.864|0.9472
73840300|NCT01197300|147228791|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-1.482||||0.46|TWO_SIDED|95.0|-3.805|0.841||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 18||0.841|-3.805|0.4600
73840301|NCT01197300|147228791|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.41||||0.9236|TWO_SIDED|95.0|-2.423|1.603||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 24||1.603|-2.423|0.9236
73840302|NCT01197300|147228792|OTHER|The number and percentage of patients with new vertebral fractures during the 12 month Extension period was presented by Core treatment group. Between-treatment differences were evaluated using Fisher's exact test.||||||1|||||||Fisher Exact|||New vertebral fractures at Month 12 Extension||||1.0000
73840303|NCT01197300|147228793|OTHER|The number and percentage of patients with new morphometric vertebral fractures during the 12 month extension period was presented by core treatment group. Between-treatment differences will be evaluated using Fisher's exact test.||||||1|||||||Fisher Exact|||New morphometric vertebral fractures at Month 12 Extension||||1.0000
73840304|NCT01197300|147228794|OTHER||Odds Ratio (OR)|4.73||||0.3971|TWO_SIDED|95.0|0.13|173.07||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 15||173.07|0.13|0.3971
73840305|NCT01197300|147228794|OTHER||Odds Ratio (OR)|0.01||||0.6046|TWO_SIDED|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 18||999.99|0.01|0.6046
73959766|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|9.8||0.8055|ONE_SIDED|95.0|-24.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.7|0.8055
73959767|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|9.5||0.6767|ONE_SIDED|95.0|-20.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-20.2|0.6767
74022310|NCT01431287|147597096|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.165|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.114|0.216||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.216|0.114|<0.0001
73840306|NCT01197300|147228794|OTHER||Odds Ratio (OR)|0.01||||0.6046|TWO_SIDED|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 21||999.99|0.01|0.6046
73840307|NCT01197300|147228794|OTHER||Odds Ratio (OR)|1.31||||0.875|TWO_SIDED|95.0|0.05|38.04||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 24||38.04|0.05|0.8750
73840308|NCT01197300|147228795|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.01||||0.9231|TWO_SIDED|95.0|-0.18|0.17||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL1 at Month 24||0.17|-0.18|0.9231
73840309|NCT01197300|147228795|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.11||||0.2694|TWO_SIDED|95.0|-0.32|0.1||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Extension baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL2 at Month 24||0.10|-0.32|0.2694
73840310|NCT00581100|147228796|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].||||||<0.0001
73840311|NCT00581100|147228796|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
74022311|NCT01431287|147597096|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.019|STANDARD_ERROR_OF_MEAN|0.026||0.4763|TWO_SIDED|95.0|-0.033|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.070|-0.033|0.4763
74022312|NCT01431287|147597096|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.1613|TWO_SIDED|95.0|-0.015|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.088|-0.015|0.1613
73840312|NCT00581100|147228797|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].||||||<0.0001
73840313|NCT00581100|147228797|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
73840314|NCT00581100|147228798|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
73840315|NCT00581100|147228798|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
73959768|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.4||0.407|ONE_SIDED|95.0|-12.0||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.0|0.4070
73959769|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|9.7||0.9705|ONE_SIDED|95.0|-34.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-34.7|0.9705
74022313|NCT01431287|147597096|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.026||0.4908|TWO_SIDED|95.0|-0.069|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.033|-0.069|0.4908
74022314|NCT01431287|147597097|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.072|0.173||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.173|0.072|<0.0001
73840316|NCT00581100|147228798|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840317|NCT00581100|147228798|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840318|NCT00581100|147228799|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.007
73840319|NCT00581100|147228799|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.006
74022315|NCT01431287|147597097|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.026||0.0154|TWO_SIDED|95.0|0.012|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.012|0.0154
73840320|NCT00581100|147228799|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840321|NCT00581100|147228799|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840322|NCT00581100|147228800|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
73840323|NCT00581100|147228800|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
73840324|NCT00581100|147228800|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840325|NCT00581100|147228800|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840326|NCT00581100|147228801|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.069
73840327|NCT00581100|147228801|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.006
73840328|NCT00581100|147228801|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840329|NCT00581100|147228801|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840330|NCT00581100|147228802|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
73840331|NCT00581100|147228802|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
74022316|NCT01431287|147597097|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.08|0.181||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.181|0.080|<0.0001
74084220|NCT03702816|147721465|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.051||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in PD Subjects||||0.84
73840332|NCT00581100|147228803|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
73840333|NCT00581100|147228803|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
73840334|NCT00581100|147228803|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840335|NCT00581100|147228803|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840336|NCT00581100|147228804|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
73840337|NCT00581100|147228804|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
73840338|NCT00581100|147228804|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840339|NCT00581100|147228804|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
73840340|NCT00581100|147228805|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change-\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
73840341|NCT00581100|147228805|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change-\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
73840342|NCT00581100|147228806|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
73840343|NCT00581100|147228806|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
73840344|NCT00581100|147228807|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
73840345|NCT00581100|147228807|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
73840346|NCT00581100|147228808|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
73840347|NCT00581100|147228808|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
73840348|NCT00581100|147228809|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
73840349|NCT00581100|147228809|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
73840350|NCT00581100|147228810|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
73840351|NCT00581100|147228810|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<Table 8-14\> Change from baseline in Physician and Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Mixed Models Analysis|||||||<0.0001
73840352|NCT00581100|147228811|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
73840353|NCT00581100|147228811|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
73840354|NCT00834574|147228812|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.2|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|97.2|
73840355|NCT00834574|147228813|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|101|
73840356|NCT00834574|147228814|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|101|
73840357|NCT05170061|147228838|SUPERIORITY|||||||0.05||||||see above|t-test, 2 sided|paired analysis||Sequential analysis: if the first analysis (paired t-test to determine superiority of nebivolol/valsartan over valsartan ) reached p\< 0.05, the superiority of nebivolol over valsartan was tested (paired-t test); if the second comparison reached p \< 0.05, the superiority of nebivolol/valsartan over nebivolol was tested (paired-t test)||||0.05
73840358|NCT05170061|147228839|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||||||0.05
73840359|NCT05170061|147228840|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840360|NCT05170061|147228841|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840361|NCT05170061|147228842|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840362|NCT05170061|147228843|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840363|NCT05170061|147228844|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840364|NCT05170061|147228845|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840365|NCT05170061|147228846|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840366|NCT05170061|147228847|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840367|NCT05170061|147228848|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840368|NCT05170061|147228849|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840369|NCT05170061|147228850|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840370|NCT05170061|147228851|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840371|NCT05170061|147228852|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840372|NCT05170061|147228853|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840373|NCT05170061|147228854|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840374|NCT05170061|147228855|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840375|NCT05170061|147228856|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840376|NCT05170061|147228857|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840377|NCT05170061|147228858|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840378|NCT05170061|147228859|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
73840379|NCT04526158|147228940|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.031|TWO_SIDED|95.0|0.0|0.6||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.6|0.0|0.031
73840380|NCT04526158|147228940|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.002|TWO_SIDED|95.0|-0.7|-0.2||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.7|0.002
73840381|NCT04526158|147228940|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.4|-1.0|<0.001
73840382|NCT04526158|147228941|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.736|TWO_SIDED|95.0|-0.2|0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.3|-0.2|0.736
73840383|NCT04526158|147228941|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.6|<0.001
73840384|NCT04526158|147228941|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.7|<0.001
73840385|NCT04526158|147228942|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.829|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.4|-0.4|0.829
73840386|NCT04526158|147228942|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.005|TWO_SIDED|95.0|0.2|0.9|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.9|0.2|0.005
73840387|NCT04526158|147228942|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.004|TWO_SIDED|95.0|0.2|1.0|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.0|0.2|0.004
73840388|NCT04526158|147228943|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.079|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.8|0.0|0.079
73840389|NCT04526158|147228943|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.296|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.2|-0.6|0.296
73840390|NCT04526158|147228943|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.005|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.0|0.005
73840391|NCT04526158|147228944|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.464|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.7|-0.3|0.464
73840392|NCT04526158|147228944|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.019|TWO_SIDED|95.0|-1.1|-0.1|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.1|-1.1|0.019
73840393|NCT04526158|147228944|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.002|TWO_SIDED|95.0|-1.3|-0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.3|-1.3|0.002
73840394|NCT04526158|147228945|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.889|TWO_SIDED|95.0|-0.5|0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.4|-0.5|0.889
73840395|NCT04526158|147228945|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.004|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.1|0.004
73840396|NCT04526158|147228945|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.006|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.1|0.006
74084221|NCT01881737|147721513|SUPERIORITY_OR_OTHER|||||||0.848|||||||Paired t test|||Effect Size Cohen's d = -0.05||||0.848
73840397|NCT04526158|147228946|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.76|TWO_SIDED|95.0|-0.4|0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.5|-0.4|0.76
73840398|NCT04526158|147228946|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.4|0.6|<0.001
73840399|NCT04526158|147228946|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.5|1.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.3|0.5|<0.001
73840400|NCT04526158|147228947|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.89|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.6|-0.7|0.89
73840401|NCT04526158|147228947|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.003|TWO_SIDED|95.0|-1.5|-0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.3|-1.5|0.003
73840402|NCT04526158|147228947|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.007|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.5|0.007
73840403|NCT04526158|147228948|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.886|TWO_SIDED|95.0|-1.6|1.9|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.9|-1.6|0.886
73840404|NCT04526158|147228948|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.017|TWO_SIDED|95.0|-3.7|-0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.4|-3.7|0.017
73840405|NCT04526158|147228948|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.013|TWO_SIDED|95.0|-3.9|-0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.5|-3.9|0.013
74084222|NCT01881737|147721514|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t test|Effect Size Cohen's d = 0.53||||||0.009
73840406|NCT04526158|147228949|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.437|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.3|-0.1|0.437
73840407|NCT04526158|147228949|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.5|-0.9|<0.001
73840408|NCT04526158|147228949|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.0|-0.6|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.6|-1.0|<0.001
73840409|NCT04526158|147228950|SUPERIORITY||Mean Difference (Final Values)|-7.5|||||TWO_SIDED|95.0|-13.9|-1.2||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-1.2|-13.9|
73840410|NCT04526158|147228950|SUPERIORITY||Mean Difference (Final Values)|12.0|||||TWO_SIDED|95.0|6.4|17.6||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||17.6|6.4|
73840411|NCT04526158|147228950|SUPERIORITY||Mean Difference (Final Values)|19.5|||||TWO_SIDED|95.0|13.6|25.4||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||25.4|13.6|
73840412|NCT01946880|147229007|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|-0.068|0.214||||||||0.214|-0.068|
73840413|NCT01946880|147229009|OTHER||Risk Difference (RD)|0.08|||||TWO_SIDED|95.0|-0.116|0.279||||||||0.279|-0.116|
73840414|NCT01946880|147229010|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.091|0.36||||||||0.360|-0.091|
73840415|NCT01946880|147229011|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|-0.07|||||TWO_SIDED|95.0|-0.475|0.333||||||||0.333|-0.475|
73840416|NCT01946880|147229012|OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|95.0|-0.286|0.249||||||The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.||0.249|-0.286|
73840417|NCT01946880|147229013|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-0.09|0.497||||||||0.497|-0.090|
73840418|NCT01946880|147229014|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.08|||||TWO_SIDED|95.0|-0.056|0.211||||||||0.211|-0.056|
74084223|NCT01881737|147721515|SUPERIORITY_OR_OTHER|||||||0.38|||||||paired t test|Effect size Cohen's d = 0.38||||||0.38
74084224|NCT01881737|147721517|SUPERIORITY_OR_OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
74084225|NCT00360490|147721567|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.||||<0.001
74022317|NCT01431287|147597097|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.084|STANDARD_ERROR_OF_MEAN|0.026||0.0012|TWO_SIDED|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.134|0.033|0.0012
74022318|NCT01431287|147597097|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.026||0.0061|TWO_SIDED|95.0|0.02|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.121|0.020|0.0061
74022319|NCT01431287|147597097|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.026||0.7518|TWO_SIDED|95.0|-0.059|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.042|-0.059|0.7518
74022320|NCT01431287|147597097|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.026||0.0034|TWO_SIDED|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.126|0.025|0.0034
74022321|NCT01431287|147597097|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.026||0.0209|TWO_SIDED|95.0|0.009|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.110|0.009|0.0209
74022322|NCT01431287|147597097|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.026||0.0708|TWO_SIDED|95.0|-0.004|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|-0.004|0.0708
74022323|NCT01431287|147597097|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.026||0.6148|TWO_SIDED|95.0|-0.038|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.064|-0.038|0.6148
74022324|NCT01431287|147597098|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.164|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.114|0.215||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.215|0.114|<0.0001
74022325|NCT01431287|147597098|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.026||0.0064|TWO_SIDED|95.0|0.02|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.122|0.020|0.0064
73840419|NCT01946880|147229015|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.12|||||TWO_SIDED|95.0|-0.041|0.284||||||||0.284|-0.041|
73840420|NCT01946880|147229016|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|-0.04|||||TWO_SIDED|95.0|-0.285|0.206||||||||0.206|-0.285|
74022326|NCT01431287|147597098|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.152|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.102|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.203|0.102|<0.0001
74022327|NCT01431287|147597098|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.026||0.0035|TWO_SIDED|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.126|0.025|0.0035
74022328|NCT01431287|147597098|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.026||0.0233|TWO_SIDED|95.0|0.008|0.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.109|0.008|0.0233
74084226|NCT00360490|147721568|SUPERIORITY_OR_OTHER||Risk Difference (RD)|62.59|||<|0.001||95.0|50.56|74.61|||Chi-squared|||The null hypothesis: the proportion of subjects with successful treatment is equal in the LNG IUS group and the MPA group.||74.61|50.56|<0.001
74084227|NCT00360490|147721569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.2|||<|0.001||95.0|-70.2|-28.3|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.||-28.3|-70.2|<0.001
73840421|NCT01946880|147229017|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.118|0.289||||||||0.289|-0.118|
73840422|NCT01946880|147229018|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.05|||||TWO_SIDED|95.0|-0.103|0.212||||||||0.212|-0.103|
73840423|NCT01946880|147229021|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.06|||||TWO_SIDED|95.0|-0.028|0.149||||||||0.149|-0.028|
73840424|NCT01946880|147229022|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.06|||||TWO_SIDED|95.0|-0.02|0.134||||||||0.134|-0.020|
73840425|NCT01946880|147229023|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 24.||0.1|-0.1|
73840426|NCT01946880|147229023|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 48.||0.1|-0.1|
73840427|NCT01946880|147229023|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 60.||0.1|-0.2|
73840428|NCT01946880|147229024|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.019|0.059||||||||0.059|-0.019|
73840429|NCT01946880|147229026|OTHER||Mean Difference (Final Values)|1.61|||||TWO_SIDED|95.0|-2.24|5.45|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 24.||5.45|-2.24|
74084228|NCT00360490|147721570|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.||||<0.001
73840430|NCT01946880|147229026|OTHER||Mean Difference (Final Values)|2.54|||||TWO_SIDED|95.0|-1.13|6.21|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 48.||6.21|-1.13|
73840431|NCT01946880|147229026|OTHER||Mean Difference (Final Values)|3.55|||||TWO_SIDED|95.0|-0.17|7.28|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 60.||7.28|-0.17|
73840432|NCT01946880|147229027|OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-1.82|2.92|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 24.||2.92|-1.82|
73840433|NCT01946880|147229027|OTHER||Mean Difference (Final Values)|1.44|||||TWO_SIDED|95.0|-1.14|4.03|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 48.||4.03|-1.14|
73840434|NCT01946880|147229027|OTHER||Mean Difference (Final Values)|1.98|||||TWO_SIDED|95.0|-0.71|4.67|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 60.||4.67|-0.71|
73840435|NCT01946880|147229028|OTHER||Mean Difference (Final Values)|1.65|||||TWO_SIDED|95.0|-1.03|4.32|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 24.||4.32|-1.03|
73840436|NCT01946880|147229028|OTHER||Mean Difference (Final Values)|2.17|||||TWO_SIDED|95.0|-0.69|5.02|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 48.||5.02|-0.69|
73840437|NCT01946880|147229028|OTHER||Mean Difference (Final Values)|3.02|||||TWO_SIDED|95.0|0.22|5.82|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 60.||5.82|0.22|
73840438|NCT04543786|147229055|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 2.|Mean Difference (Final Values)|2.8||||0.0048|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|One-way||||||0.0048
73840439|NCT04543786|147229056|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 3.|Mean Difference (Final Values)|3.72|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||< 0.001
74084229|NCT00360490|147721571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.6|||<|0.001||95.0|-63.8|-37.4|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.||-37.4|-63.8|<0.001
73840440|NCT04543786|147229057|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 4.|Mean Difference (Final Values)|3.24|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||<0.001
73840441|NCT04543786|147229058|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 5.|Mean Difference (Final Values)|20.84|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||<0.001
73840442|NCT04543786|147229060|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 5.|Mean Difference (Final Values)|26.78|||<|0.001|TWO_SIDED|||||p \< 0.05 was considered significant|t-test, 2 sided|paired||||||<0.001
73840443|NCT04543786|147229061|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|1.3||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
73840444|NCT04543786|147229062|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|2.3||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
73840445|NCT04543786|147229063|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|1.2||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
73840446|NCT04543786|147229064|OTHER|No comparison was made to another intervention or therapy.|Mean Difference (Final Values)|1.5||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
73840447|NCT04204902|147229065|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least Square Mean|91.15|||||TWO_SIDED|90.0|83.21|99.84||||||||99.84|83.21|
74022329|NCT01431287|147597098|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.026||0.6413|TWO_SIDED|95.0|-0.039|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|-0.039|0.6413
73840448|NCT04204902|147229066|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least square Mean|90.92|||||TWO_SIDED|90.0|82.99|99.61||||||||99.61|82.99|
73840449|NCT04204902|147229067|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least Square Mean|104.62|||||TWO_SIDED|90.0|95.17|115.0||||||||115.00|95.17|
73840450|NCT00456365|147229078|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
73840451|NCT00456365|147229079|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||||||0.02
73840452|NCT00456365|147229080|SUPERIORITY_OR_OTHER|||||||0.69|||||||ANOVA|||||||0.69
73840453|NCT00456365|147229081|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANCOVA|||||||0.21
73840454|NCT02202577|147229084|SUPERIORITY||Risk Ratio (RR)|0.9||||0.38|ONE_SIDED|95.0||1.35||This is the calculated p-value for the intention to treat analysis of primary outcome. A 1-tailed p value of \<0.05 was selected for statistical significance.|Fisher Exact|||"We estimated a cesarean related surgical site infection rate of 7.5% with povidone-iodine and hypothesized chlorhexidine-alcohol treatment to be superior based on existing literature. We considered a 50% reduction to be significant. We performed our power analysis assuming~1-directional effects in favor of chlorhexidine, which best fit our hypothesis. Using a 1-tailed alpha of 0.05 and an 80% power to detect a difference, we estimated that 466 subjects would be required in each group."||1.35||0.38
73840455|NCT02202577|147229084|SUPERIORITY||Risk Ratio (RR)|0.83||||0.26|ONE_SIDED|95.0||1.25||This is the calculated p-value for the per protocol analysis of primary outcome. A 1-tailed p value of \<0.05 was selected for statistical significance.|Fisher Exact|||Per Protocol Analysis||1.25||0.26
73840456|NCT00829868|147229086|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|109.0||||||90.0|99.3|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||120|99.3|
73840457|NCT00829868|147229087|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|101.0||||||90.0|97.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|97.5|
73840458|NCT00829868|147229088|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|100.0||||||90.0|96.2|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|96.2|
73840459|NCT06091956|147229093|SUPERIORITY|||||||0.008|||||||McNemar|||||||0.008
73840460|NCT06091956|147229094|SUPERIORITY|||||||0.629|||||||Wilcoxon (Mann-Whitney)|||||||0.629
73840461|NCT06091956|147229097|SUPERIORITY|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||||||0.175
73840462|NCT06091956|147229098|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
73840463|NCT01421459|147229113|NON_INFERIORITY_OR_EQUIVALENCE|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week endpoint HbA1c for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|0.052||||0.403|TWO_SIDED|95.0|-0.07|0.175|||ANCOVA|||||0.175|-0.070|0.403
73840464|NCT01421459|147229115|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P-value is for 4 weeks.|ANCOVA|||||||0.382
73840465|NCT01421459|147229115|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||P-value is for 8 weeks.|ANCOVA|||||||0.910
73840466|NCT01421459|147229115|SUPERIORITY_OR_OTHER|||||||0.869||95.0||||P-value is for 12 weeks.|ANCOVA|||||||0.869
73840467|NCT01421459|147229115|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for 16 weeks.|ANCOVA|||||||0.345
73840468|NCT01421459|147229115|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for 20 weeks.|ANCOVA|||||||0.161
74084230|NCT00360490|147721581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.06||||||95.0|14.75|37.36||||||A two-sided 95% confidence interval for the improvement rate will be provided for cycle 6||37.36|14.75|
74084231|NCT02033317|147721584|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.14|TWO_SIDED||||||paired t-test|||||||= 0.14
73840469|NCT01421459|147229115|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-value is for 24 weeks.|ANCOVA|||||||0.097
73840470|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is at Morning Pre-Meal at Baseline.|ANCOVA|||||||0.837
73840471|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-value is for Morning 2 hrs PP Meal at Baseline.|ANCOVA|||||||0.620
73840472|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P-value is for Midday Pre-Meal at Baseline|ANCOVA|||||||0.107
73840473|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for Midday 2 hrs PP Meal at Baseline.|ANCOVA|||||||0.258
73840474|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Evening Pre-Meal at Baseline.|ANCOVA|||||||0.161
73840475|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||P-value is for Bed Time at Baseline.|ANCOVA|||||||0.725
73840476|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||P-value is for 0300 hrs at Baseline.|ANCOVA|||||||0.543
73840477|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.265||95.0||||P-value is for Morning Pre-Meal at Endpoint, up to 24 wk.|ANCOVA|||||||0.265
73840478|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for Morning 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.050
73840479|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value is for Midday Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.040
73840480|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||P-value is for Midday 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.366
73840481|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.485||95.0||||P-value is for Evening Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.485
73840482|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.537||95.0||||P-value is for Bed Time at Endpoint, up to 24 weeks.|ANCOVA|||||||0.537
73840483|NCT01421459|147229116|SUPERIORITY_OR_OTHER|||||||0.878||95.0||||P-value is for 0300 hrs at Endpoint, up to 24 weeks.|ANCOVA|||||||0.878
73840484|NCT01421459|147229117|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-value is for Baseline.|ANCOVA|||||||0.779
73840485|NCT01421459|147229117|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-value is for Endpoint, up to 24 weeks.|ANCOVA|||||||0.788
73840486|NCT01421459|147229118|SUPERIORITY_OR_OTHER|||||||0.687||95.0||||P-value is for Baseline.|ANCOVA|||||||0.687
73840487|NCT01421459|147229118|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value is for change at 4 wks.|ANCOVA|||||||0.036
73840488|NCT01421459|147229118|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||P-value is for change at 8 wks.|ANCOVA|||||||0.323
73840489|NCT01421459|147229118|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-value is for change at 12 wks.|ANCOVA|||||||0.368
73840490|NCT01421459|147229118|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for change at 16 wks.|ANCOVA|||||||0.089
73840491|NCT01421459|147229118|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value is for change at 20 wks.|ANCOVA|||||||0.041
73840492|NCT01421459|147229118|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||P-value is for change at 24 wks.|ANCOVA|||||||0.330
73840493|NCT01421459|147229118|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value is for change at Endpoint, up to 24 wks.|ANCOVA|||||||0.334
73840494|NCT01421459|147229119|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Behavior domain at 4 weeks.|ANCOVA|||||||0.726
73840495|NCT01421459|147229119|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for Behavior domain at 12 weeks.|ANCOVA|||||||0.502
73840496|NCT01421459|147229119|SUPERIORITY_OR_OTHER|||||||0.437||95.0||||P-value is for Behavior domain at Endpoint, up to 24 weeks.|ANCOVA|||||||0.437
73840497|NCT01421459|147229119|SUPERIORITY_OR_OTHER|||||||0.237||95.0||||P-value is for Worry domain at 4 weeks.|ANCOVA|||||||0.237
73840498|NCT01421459|147229119|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||P-value is for Worry domain at 12 weeks.|ANCOVA|||||||0.860
73840499|NCT01421459|147229119|SUPERIORITY_OR_OTHER|||||||0.966||95.0||||P-value is for Worry domain at Endpoint, up to 24 weeks.|ANCOVA|||||||0.966
73840500|NCT01421459|147229119|SUPERIORITY_OR_OTHER|||||||0.313||95.0||||P-value is for ALBSS Total Score at 4 weeks.|ANCOVA|||||||0.313
73840501|NCT01421459|147229119|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||P-value is for ALBSS Total Score at 12 weeks.|ANCOVA|||||||0.683
73840502|NCT01421459|147229119|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||P-value is for ALBSS Total Score at Endpoint, up to 24 weeks.|ANCOVA|||||||0.765
73840503|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value is for Inconvenience of Regimen at 4 weeks.|ANCOVA|||||||0.983
73840504|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for Inconvenience of Regimen at 12 weeks.|ANCOVA|||||||0.371
73840505|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.757||95.0||||P-value is for Inconvenience of Regimen at Endpoint, up to 24 weeks.|ANCOVA|||||||0.757
73840506|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||P-value is for Lifestyle Flexibility at 4 weeks.|ANCOVA|||||||0.890
73840507|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.326||95.0||||P-value is for Lifestyle Flexibility at 12 weeks.|ANCOVA|||||||0.326
73840508|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||P-value is for Lifestyle Flexibility at Endpoint, up to 24 weeks.|ANCOVA|||||||0.831
73840509|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-value is for Hypoglycemic Control at 4 weeks.|ANCOVA|||||||0.507
73840510|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for Hypoglycemic Control at 12 weeks.|ANCOVA|||||||0.690
73840511|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||P-value is for Hypoglycemic Control at Endpoint, up to 24 weeks.|ANCOVA|||||||0.307
73840512|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value is for Glycemic Control at 4 weeks.|ANCOVA|||||||0.902
73840513|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||P-value is for Glycemic Control at 12 weeks.|ANCOVA|||||||0.109
73840514|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||P-value is for Glycemic Control at Endpoint, up to 24 weeks.|ANCOVA|||||||0.754
73840515|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||P-value is for Insulin Deliver Device at 4 weeks.|ANCOVA|||||||0.088
73840516|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.456||95.0||||P-value is for Insulin Delivery Device at 12 weeks.|ANCOVA|||||||0.456
73840517|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.531||95.0||||P-value is for Insulin Delivery Device at Endpoint, up to 24 weeks.|ANCOVA|||||||0.531
73840518|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value is for ITSQ Total Score at 4 weeks.|ANCOVA|||||||0.393
73840519|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||P-value is for ITSQ Total Score at 12 weeks.|ANCOVA|||||||0.296
73840520|NCT01421459|147229120|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||P-value is for ITSQ Total Score at Endpoint, up to 24 weeks.|ANCOVA|||||||0.662
73840521|NCT01421459|147229121|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||ANCOVA|||||||0.393
73840522|NCT01421459|147229122|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value is for Insulin Dose at Endpoint, up to 24 weeks.|ANOVA|||||||0.185
73840523|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||P-value is for HbA1c \<7% at Baseline.|Chi-squared|||||||0.661
73840524|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value is for HbA1c ≤ 6.5% at Baseline.|Chi-squared|||||||0.394
73840525|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-value is for HbA1c \<7% at 4 weeks.|Chi-squared|||||||0.688
73840526|NCT01421459|147229123|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||P-value is for HbA1c ≤ 6.5% at 4 weeks.|Chi-squared|||||||>0.999
73959770|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|9.4||0.8249|ONE_SIDED|95.0|-24.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.6|0.8249
73840527|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.409||95.0||||P-value is for HbA1c \<7% at 8 weeks.|Chi-squared|||||||0.409
73840528|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value is for HbA1c ≤ 6.5% at 8 weeks.|Chi-squared|||||||0.090
73840529|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value is for HbA1c \<7% at 12 weeks.|Chi-squared|||||||0.319
73840530|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-value is for HbA1c ≤6.5% at 12 weeks.|Chi-squared|||||||0.463
73840531|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||P-value is for HbA1c \<7% at 16 weeks.|Chi-squared|||||||0.128
73840532|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value is for HbA1c ≤6.5% at 16 weeks.|Chi-squared|||||||0.261
73840533|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value is for HbA1c \<7% at 20 weeks.|Chi-squared|||||||0.218
73840534|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for HbA1c ≤6.5% at 20 weeks.|Chi-squared|||||||0.092
73840535|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value is for HbA1c \<7%% at 24 weeks.|Chi-squared|||||||0.186
73840536|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value is for HbA1c ≤6.5% at 24 weeks.|Chi-squared|||||||0.174
73840537|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value is for HbA1c \<7% at Endpoint, up to 24 weeks.|Chi-squared|||||||0.340
73840538|NCT01421459|147229123|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||P-value is for HbA1c ≤6.5% at Endpoint, up to 24 weeks.|Chi-squared|||||||0.293
73840539|NCT01421459|147229124|SUPERIORITY_OR_OTHER|||||||0.594||95.0||||P-value is for Total Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared|||||||0.594
73840540|NCT01421459|147229124|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-value is for Nocturnal Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared|||||||0.462
73840541|NCT01421459|147229125|SUPERIORITY_OR_OTHER|||||||0.995||95.0||||P-value is for Total Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)|||||||0.995
73840542|NCT01421459|147229125|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||P-value is for Nocturnal Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)|||||||0.686
73840543|NCT01421459|147229126|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-value is for Baseline.|Chi-squared|||||||0.285
73840544|NCT01421459|147229126|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for 4 weeks.|Chi-squared|||||||0.047
73840545|NCT01421459|147229126|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||P-value is for 12 weeks.|Chi-squared|||||||0.882
73840546|NCT01421459|147229126|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for 24 weeks.|Chi-squared|||||||0.179
73840547|NCT01421459|147229126|SUPERIORITY_OR_OTHER|||||||0.314||95.0||||P-value is for Endpoint, up to 24 weeks.|Chi-squared|||||||0.314
73840548|NCT01421459|147229126|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value is for Baseline to 24 weeks (Overall).|Chi-squared|||||||0.100
73840549|NCT01421459|147229127|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-value is for 4 weeks.|Chi-squared|||||||0.176
73840550|NCT01421459|147229127|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||P-value is for 12 weeks.|Chi-squared|||||||0.999
73840551|NCT01421459|147229127|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||P-value is for 24 weeks.|Chi-squared|||||||0.618
73840552|NCT01421459|147229127|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||P-value is for Endpoint (LOCF).|Chi-squared|||||||0.874
73840553|NCT01421459|147229127|SUPERIORITY_OR_OTHER||||||>|0.233||95.0||||P-value is for Overall (Baseline to 24 weeks).|Chi-squared|||||||>0.233
73840554|NCT02899754|147229128|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Primary outcome assessed at 1 month post-intervention||||0.18
73840555|NCT02899754|147229130|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73840556|NCT02899754|147229131|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
73840557|NCT02899754|147229132|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
73840558|NCT02899754|147229133|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||||||0.22
73840559|NCT02899754|147229134|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
73840560|NCT02899754|147229135|SUPERIORITY|||||||0.01|||||||Chi-squared|||chi-square test||||0.01
73840561|NCT02899754|147229136|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
73840562|NCT02592655|147229155|SUPERIORITY_OR_OTHER|||||||0.002||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as the 10 cm wide tourniquet tape.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.002
73840563|NCT02592655|147229155|SUPERIORITY_OR_OTHER|||||||0.008||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.008
74084232|NCT02033317|147721585|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.02|TWO_SIDED||||||paired t-test|||||||= 0.02
73840564|NCT02592655|147229155|SUPERIORITY_OR_OTHER|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that the 10 cm wide tourniquet tape is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.5
73840565|NCT02592655|147229155|SUPERIORITY_OR_OTHER|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that using the pneumatic tourniquet is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 17 to accommodate for missing ultrasound data."||||0.5
73840566|NCT03996395|147229158|OTHER||Descriptive statistic|71.0|STANDARD_DEVIATION|23.0|||TWO_SIDED|||||||||||||
73840567|NCT00392288|147229167|SUPERIORITY_OR_OTHER|||||||0.2696||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. In this pairwise comparison Ciclesonide was compared with Placebo by testing the average effect of Ciclesonide 40 and Ciclesonide 80 versus Placebo. As statistical test a t-test was used to compare the corresponding least-square means of both treatment groups.||||0.2696
73840568|NCT00392288|147229167|SUPERIORITY_OR_OTHER|||||||0.0703||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. A t-test was used to compare the least-square means of Ciclesonide 80 versus Placebo.||||0.0703
73840569|NCT00392288|147229167|SUPERIORITY_OR_OTHER|||||||0.9146||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. As statistical test a t-test was used to compare the corresponding least-square means of Ciclesonide 40 versus Placebo.||||0.9146
73840570|NCT02544763|147229170|SUPERIORITY||Percentage reduction|48.6|||||TWO_SIDED|95.0|40.4|55.8||||||||55.8|40.4|
73840571|NCT02544763|147229170|SUPERIORITY||Percentage reduction|47.5|||||TWO_SIDED|95.0|39.0|54.8||||||||54.8|39.0|
73840572|NCT02544763|147229170|SUPERIORITY||Percentage reduction|26.5|||||TWO_SIDED|95.0|14.9|36.5||||||||36.5|14.9|
73840573|NCT02544763|147229170|SUPERIORITY||Treatment ratio|0.699|||=|0.0009|TWO_SIDED|95.0|0.567|0.861|||Mixed Models Analysis|||||0.861|0.567|=0.0009
73840574|NCT02544763|147229170|SUPERIORITY||Treatment ratio|0.715|||=|0.0018|TWO_SIDED|95.0|0.58|0.881|||Mixed Models Analysis|||||0.881|0.580|=0.0018
73840575|NCT02544763|147229171|SUPERIORITY||Odds Ratio (OR)|1.95|||=|0.0692|TWO_SIDED|95.0|0.95|4.0|||Cochran-Mantel-Haenszel|The p-value was calculated from a Cochran-Mantel-Haenszel test stratified by age group (1-6, 7-11, 12-17 and 18-65 years).||||4.00|0.95|=0.0692
73840576|NCT02544763|147229171|SUPERIORITY||Odds Ratio (OR)|2.29|||=|0.0245|TWO_SIDED|95.0|1.12|4.67|||Cochran-Mantel-Haenszel|The p-value was calculated from a Cochran-Mantel-Haenszel test stratified by age group (1-6, 7-11, 12-17 and 18-65 years).||||4.67|1.12|=0.0245
73840577|NCT02544763|147229172|SUPERIORITY||Odds Ratio (OR)|2.25|||=|0.0074|TWO_SIDED|95.0|1.24|4.07|||nominal|The global impression of change was analyzed using an ordinal logistic regression model with treatment group as a fixed factor.||||4.07|1.24|=0.0074
73840578|NCT02544763|147229172|SUPERIORITY||Odds Ratio (OR)|1.77|||=|0.058|TWO_SIDED|95.0|0.98|3.2|||nominal|The global impression of change is analyzed using an ordinal logistic regression model with treatment group as a fixed factor.||||3.20|0.98|=0.0580
74084233|NCT03919695|147721598|SUPERIORITY||Odds Ratio (OR)|0.29||||0.002|TWO_SIDED|95.0|0.11|0.73|||GEE model specifying a logistic distribu||time x arm effect for the comparison at 6-month follow-up|Generalized Estimating Equations (GEE) model specifying a logistic distribution examining the time x arm interaction||.73|.11|.002
73840579|NCT02544763|147229173|SUPERIORITY|Model includes the total number of seizures as a response variable and age group, time (Baseline and treatment period), treatment and treatment by time interaction as fixed effects and participant as a random effect. The log transformed number of days seizures were reported by period is included as an offset.|Percentage reduction|0.519|||||TWO_SIDED|95.0|0.447|0.602||||||||0.602|0.447|
73840580|NCT02544763|147229173|SUPERIORITY||Percentage reduction|0.524|||||TWO_SIDED|95.0|0.452|0.607||||||||0.607|0.452|
73840581|NCT02544763|147229173|SUPERIORITY||Percentage reduction|0.731|||||TWO_SIDED|95.0|0.632|0.846||||||||0.846|0.632|
73840582|NCT02544763|147229173|SUPERIORITY||Treatment ratio|0.709|||=|0.0013|TWO_SIDED|95.0|0.576|0.873|||Mixed Models Analysis|||||0.873|0.576|=0.0013
73840583|NCT02544763|147229173|SUPERIORITY||Treatment ratio|0.716|||=|0.0018|TWO_SIDED|95.0|0.582|0.882|||Mixed Models Analysis|||||0.882|0.582|=0.0018
73840584|NCT05135754|147229184|SUPERIORITY||Risk Ratio (RR)|0.59||||0.046|TWO_SIDED|95.0|0.35|0.99|||Mixed Models Analysis|||||0.99|0.35|0.046
73840585|NCT05135754|147229185|SUPERIORITY||Mean Difference (Final Values)|6.61|||<|0.001|TWO_SIDED|95.0|3.45|9.78|||Mixed Models Analysis|||||9.78|3.45|<0.001
73840586|NCT05135754|147229186|SUPERIORITY||Mean Difference (Final Values)|20.01|||<|0.001|TWO_SIDED|95.0|15.02|25.0|||Mixed Models Analysis|||||25.00|15.02|<0.001
73840587|NCT05135754|147229187|SUPERIORITY||Mean Difference (Final Values)|6.32|||<|0.001|TWO_SIDED|95.0|2.71|9.94|||Mixed Models Analysis|||||9.94|2.71|<0.001
73840588|NCT05135754|147229188|SUPERIORITY||Mean Difference (Final Values)|14.3|||<|0.001|TWO_SIDED|95.0|8.26|20.35|||Mixed Models Analysis|||||20.35|8.26|<0.001
73840589|NCT05135754|147229189|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.075|TWO_SIDED||||||Mixed Models Analysis|||||||0.075
74084234|NCT00608634|147721614|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.10
74084235|NCT00608634|147721614|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
74084236|NCT00608634|147721615|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
74084237|NCT00749658|147721678|OTHER|Two tailed testing||||||0.07|||||||SAS|||||||0.07
73840590|NCT05135754|147229190|SUPERIORITY||Mean Difference (Final Values)|4.68||||0.004|TWO_SIDED|95.0|1.55|7.81|||Mixed Models Analysis|||||7.81|1.55|0.004
73840591|NCT02757963|147229214|OTHER||Proportion|0.883|||||TWO_SIDED|95.0|0.849|0.912|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|||0.912|0.849|
73840592|NCT02757963|147229215|OTHER||Proportion|0.877|||||TWO_SIDED|95.0|0.846|0.904|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.904|0.846|
73840593|NCT02757963|147229215|OTHER||Proportion|0.889|||||TWO_SIDED|95.0|0.854|0.917|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.917|0.854|
73840594|NCT02757963|147229215|OTHER||Proportion|0.873|||||TWO_SIDED|95.0|0.843|0.9|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 or BPE/BPO \>=3||0.900|0.843|
73840595|NCT02757963|147229216|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.87|0.926|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.926|0.870|
73840596|NCT02757963|147229216|OTHER||Proportion|0.907|||||TWO_SIDED|95.0|0.873|0.934|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO \>=3||0.934|0.873|
73840597|NCT02757963|147229216|OTHER||Proportion|0.907|||||TWO_SIDED|95.0|0.873|0.935|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.935|0.873|
73840598|NCT02757963|147229216|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.87|0.925|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm PSS \>=8 or BPE/BPO \>=3||0.925|0.870|
73840599|NCT02757963|147229217|OTHER||Proportion|0.362|||||TWO_SIDED|95.0|0.337|0.386|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.386|0.337|
73840600|NCT02757963|147229217|OTHER||Proportion|0.368|||||TWO_SIDED|95.0|0.341|0.395|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO \>=3||0.395|0.341|
73840601|NCT02757963|147229217|OTHER||Proportion|0.377|||||TWO_SIDED|95.0|0.349|0.406|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.406|0.349|
73840602|NCT02757963|147229217|OTHER||Proportion|0.355|||||TWO_SIDED|95.0|0.332|0.379|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 or BPE/BPO \>=3||0.379|0.332|
73840603|NCT02757963|147229218|OTHER||Kappa statistic|0.55|||||TWO_SIDED|95.0|0.51|0.58||||||||0.58|0.51|
73840604|NCT00761137|147229259|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||"Primary outcome was analyzed by a mixed-effects ANOVA model employing subject as a random factor as well as visit and treatment as fixed factors. Intention-to-treat (ITT) sample was analyzed. Unweighted means and their 95% Confidence Interval (CI) are reported, which represent treatment group means adjusted for the effect of visit and removing the intra-subject variability. For all analyses, significance level was set at 5%."||||0.6
73840605|NCT04548219|147229261|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.907|||||TWO_SIDED|90.0|0.775|1.06||||||||1.06|0.775|
73840606|NCT04548219|147229262|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.915|||||TWO_SIDED|90.0|0.761|1.1||||||||1.10|0.761|
73840607|NCT04548219|147229263|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.915|||||TWO_SIDED|90.0|0.76|1.1||||||||1.10|0.760|
73959771|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|8.3||0.9345|ONE_SIDED|95.0|-26.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-26.6|0.9345
74084238|NCT01525628|147721679|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|251.37|STANDARD_DEVIATION|31.0||1|TWO_SIDED|90.0|205.54|307.43|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||307.43|205.54|1.0000
73840608|NCT02579759|147229284|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.008|TWO_SIDED|97.5|-0.68|-0.06|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.06|-0.68|0.008
73840609|NCT02579759|147229284|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.287|TWO_SIDED|97.5|-0.39|0.14|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.14|-0.39|0.287
73840610|NCT02579759|147229284|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13||0.013|TWO_SIDED|97.5|-0.59|-0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~3. Missing value imputation: No imputation"||-0.03|-0.59|0.013
73840611|NCT02579759|147229284|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.05|TWO_SIDED|97.5|-0.42|0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~3. Missing value imputation: No imputation"||0.03|-0.42|0.05
73840612|NCT02579759|147229284|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.31|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.04|-0.31|0.013
73840613|NCT02579759|147229285|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.016|TWO_SIDED|97.5|-0.91|-0.03|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.03|-0.91|0.016
73840614|NCT02579759|147229285|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.084|TWO_SIDED|97.5|-0.65|0.08|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.08|-0.65|0.084
73840615|NCT02579759|147229285|SUPERIORITY||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.015|TWO_SIDED|95.0|-0.41|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.04|-0.41|0.015
73840616|NCT02579759|147229286|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.162|TWO_SIDED|97.5|-1.01|0.23|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.23|-1.01|0.162
73840617|NCT02579759|147229286|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.556|TWO_SIDED|97.5|-0.66|0.39|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.39|-0.66|0.556
73840618|NCT02579759|147229286|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.204|TWO_SIDED|95.0|-0.43|0.09|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.09|-0.43|0.204
73840619|NCT02579759|147229287|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.36||0.232|TWO_SIDED|97.5|-1.25|0.38|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.38|-1.25|0.232
73840620|NCT02579759|147229287|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.31||0.868|TWO_SIDED|97.5|-0.74|0.64|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.64|-0.74|0.868
73840621|NCT02579759|147229287|SUPERIORITY||Slope|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.322|TWO_SIDED|95.0|-0.53|0.17|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.17|-0.53|0.322
73840622|NCT02579759|147229288|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.46||0.377|TWO_SIDED|97.5|-1.43|0.62|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.62|-1.43|0.377
73840623|NCT02579759|147229288|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.38||0.334|TWO_SIDED|97.5|-1.21|0.48|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.48|-1.21|0.334
73840624|NCT02579759|147229288|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.22||0.373|TWO_SIDED|95.0|-0.62|0.23|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.23|-0.62|0.373
73840625|NCT02579759|147229292|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.13||0.023|TWO_SIDED|97.5|-0.58|0.0|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0|-0.58|0.023
73840626|NCT02579759|147229292|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.162|TWO_SIDED|97.5|-0.4|0.09|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.09|-0.4|0.162
73840627|NCT02579759|147229296|SUPERIORITY||Odds Ratio (OR)|2.09||||0.097|TWO_SIDED|97.5|0.77|5.68|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||5.68|0.77|0.097
73840628|NCT02579759|147229296|SUPERIORITY||Odds Ratio (OR)|1.07||||0.865|TWO_SIDED|97.5|0.42|2.7|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||2.7|0.42|0.865
73840629|NCT02579759|147229297|SUPERIORITY||Odds Ratio (OR)|3.39||||0.026|TWO_SIDED|97.5|0.99|11.62|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||11.62|0.99|0.026
73840630|NCT02579759|147229297|SUPERIORITY||Odds Ratio (OR)|1.26||||0.569|TWO_SIDED|97.5|0.5|3.16|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||3.16|0.5|0.569
73840631|NCT02410200|147229300|SUPERIORITY_OR_OTHER|||||||0.009|||||||Wilcoxon Signed Rank test|||||||0.0090
73840632|NCT01149460|147229314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|111.34|||||TWO_SIDED|90.0|100.54|123.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||123.29|100.54|
73840633|NCT01149460|147229315|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||TWO_SIDED|90.0|96.34|103.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||103.82|96.34|
73840634|NCT01149460|147229316|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||TWO_SIDED|90.0|96.38|103.78|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||103.78|96.38|
73840635|NCT01149460|147229317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|103.48|||||TWO_SIDED|90.0|97.87|109.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||109.41|97.87|
73863168|NCT01073930|147272412|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|11.4|||||ONE_SIDED|97.5|5.2|||||||Overall: Ascending, mid, and recto-sigmoid colon comparison|||5.2|
73840636|NCT01149460|147229318|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|99.2|||||TWO_SIDED|90.0|97.14|101.31|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||101.31|97.14|
73840637|NCT01149460|147229319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means|99.1|||||TWO_SIDED|90.0|97.04|101.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||101.19|97.04|
73840638|NCT00839930|147229320|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.39||||||90.0|87.33|99.86|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.86|87.33|
73840639|NCT00839930|147229321|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.14||||||90.0|91.04|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.52|91.04|
73840640|NCT00839930|147229322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.64||||||90.0|92.13|101.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.37|92.13|
73840641|NCT02272985|147229334|OTHER||||||=|0.03||||||the p value was calculated|Mixed Models Analysis|||||||=0.03
73959772|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|11.0||0.7384|ONE_SIDED|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-25.3|0.7384
73959773|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|10.7||0.5239|ONE_SIDED|95.0|-18.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-18.4|0.5239
73840642|NCT02272985|147229335|OTHER|||||||0.001|||||||Mixed Models Analysis|||Left frontal gray matter:||||0.001
73840643|NCT02272985|147229335|OTHER|||||||0.08|||||||Mixed Models Analysis|||Right frontal gray matter:||||0.08
73840644|NCT00266032|147229350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|STANDARD_DEVIATION|29.0|<|0.0001||95.0|-29.0|-20.0|||t-test, 2 sided||Mean of Yaz flexible regimen minus mean of Yaz standard was tested|Primary variable was tested for the hypothesis, whether the means are equal against the alternative (means are different) at a level of significance of alpha = 0.05 (t-test). For power calculation, a normal distribution, a absolute difference of 10 days, a Standard Deviation of 28 days and a drop-out rate of 40% was assumed.||-20|-29|<0.0001
73840645|NCT04250207|147229415|SUPERIORITY|||||||0.0065|||||||Other (Wilcoxon Rank Sum Test)|||||||0.0065
73840646|NCT04250207|147229415|SUPERIORITY|||||||0.0344|||||||Other (Wilcoxon Rank Sum Test)|||||||0.0344
73840647|NCT04250207|147229416|SUPERIORITY|||||||0.3587|||||||Wilcoxon Rank Sum Test|||Baseline||||0.3587
73840648|NCT04250207|147229416|SUPERIORITY|||||||0.5724|||||||Wilcoxon Rank Sum Test|||Baseline||||0.5724
73840649|NCT04250207|147229416|SUPERIORITY|||||||0.3703|||||||Wilcoxon Rank Sum Test|||Week 1||||0.3703
73840650|NCT04250207|147229416|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 1||||> 0.9999
73840651|NCT04250207|147229416|SUPERIORITY|||||||0.3703|||||||Wilcoxon Rank Sum Test|||Week 2||||0.3703
73840652|NCT04250207|147229416|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 2||||> 0.9999
73840653|NCT04250207|147229416|SUPERIORITY|||||||0.0257|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0257
73840654|NCT04250207|147229416|SUPERIORITY|||||||0.7263|||||||Wilcoxon Rank Sum Test|||||||0.7263
73840655|NCT04250207|147229416|SUPERIORITY|||||||0.0607|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0607
73840656|NCT04250207|147229416|SUPERIORITY|||||||0.046|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0460
73840657|NCT04250207|147229416|SUPERIORITY|||||||0.0111|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0111
73840658|NCT04250207|147229416|SUPERIORITY|||||||0.0011|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0011
73840659|NCT04250207|147229416|SUPERIORITY|||||||0.02|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0200
73840660|NCT04250207|147229416|SUPERIORITY|||||||0.0476|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0476
73840661|NCT04250207|147229416|SUPERIORITY|||||||0.0065|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0065
73840662|NCT04250207|147229416|SUPERIORITY|||||||0.0344|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0344
73840663|NCT04250207|147229416|SUPERIORITY|||||||0.025|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0250
73840664|NCT04250207|147229416|SUPERIORITY|||||||0.0733|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0733
73840665|NCT04250207|147229416|SUPERIORITY|||||||0.0072|||||||Wilcoxon Rank Sum Test|||Week 20||||0.0072
73840666|NCT04250207|147229416|SUPERIORITY|||||||0.1124|||||||Wilcoxon Rank Sum Test|||Week 20||||0.1124
73840667|NCT04250207|147229416|SUPERIORITY|||||||0.0199|||||||Wilcoxon Rank Sum Test|||Week 24||||0.0199
74084239|NCT01525628|147721679|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|131.3|STANDARD_DEVIATION|32.5||0.6514|TWO_SIDED|90.0|105.4|163.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||163.57|105.40|0.6514
73840668|NCT04250207|147229416|SUPERIORITY|||||||0.2331|||||||Wilcoxon Rank Sum Test|||Week 24||||0.2331
73840669|NCT04250207|147229416|SUPERIORITY|||||||0.0024|||||||Wilcoxon Rank Sum Test|||Week 38||||0.0024
73840670|NCT04250207|147229416|SUPERIORITY|||||||0.1672|||||||Wilcoxon Rank Sum Test|||Week 38||||0.1672
73840671|NCT04250207|147229416|SUPERIORITY|||||||0.0047|||||||Wilcoxon Rank Sum Test|||Week 52||||0.0047
73840672|NCT04250207|147229416|SUPERIORITY|||||||0.0625|||||||Wilcoxon Rank Sum Test|||Week 52||||0.0625
73840673|NCT04250207|147229417|SUPERIORITY|||||||0.2434|||||||Wilcoxon Rank Sum Test|||Week 1||||0.2434
73840674|NCT04250207|147229417|SUPERIORITY|||||||0.2126|||||||Wilcoxon Rank Sum Test|||Week 1||||0.2126
73840675|NCT04250207|147229417|SUPERIORITY|||||||0.079|||||||Wilcoxon Rank Sum Test|||Week 2||||0.0790
73840676|NCT04250207|147229417|SUPERIORITY|||||||0.3043|||||||Wilcoxon Rank Sum Test|||Week 2||||0.3043
73840677|NCT04250207|147229417|SUPERIORITY|||||||0.0357|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0357
73840678|NCT04250207|147229417|SUPERIORITY|||||||0.0803|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0803
73840679|NCT04250207|147229417|SUPERIORITY|||||||0.015|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0150
73959774|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|9.4||0.417|ONE_SIDED|95.0|-13.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-13.7|0.4170
73840680|NCT04250207|147229417|SUPERIORITY|||||||0.0012|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0012
73840681|NCT04250207|147229417|SUPERIORITY|||||||0.0314|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0314
73840682|NCT04250207|147229417|SUPERIORITY|||||||0.0019|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0019
73840683|NCT04250207|147229417|SUPERIORITY|||||||0.017|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0170
73840684|NCT04250207|147229417|SUPERIORITY|||||||0.0021|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0021
73840685|NCT04250207|147229417|SUPERIORITY|||||||0.0127|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0127
73840686|NCT04250207|147229417|SUPERIORITY|||||||0.0014|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0014
73959775|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|10.3||0.7695|ONE_SIDED|95.0|-24.8||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.8|0.7695
73840687|NCT04250207|147229417|SUPERIORITY|||||||0.0677|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0677
73840688|NCT04250207|147229417|SUPERIORITY|||||||0.0243|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0243
73840689|NCT04250207|147229417|SUPERIORITY|||||||0.1867|||||||Wilcoxon Rank Sum Test|||Week 20||||0.1867
73840690|NCT04250207|147229417|SUPERIORITY|||||||0.025|||||||Wilcoxon Rank Sum Test|||Week 20||||0.0250
73840691|NCT04250207|147229417|SUPERIORITY|||||||0.3213|||||||Wilcoxon Rank Sum Test|||Week 24||||0.3213
73840692|NCT04250207|147229417|SUPERIORITY|||||||0.0298|||||||Wilcoxon Rank Sum Test|||Week 24||||0.0298
73840693|NCT04250207|147229417|SUPERIORITY|||||||0.1449|||||||Wilcoxon Rank Sum Test|||Week 38||||0.1449
73840694|NCT04250207|147229417|SUPERIORITY|||||||0.0947|||||||Wilcoxon Rank Sum Test|||Week 38||||0.0947
73840695|NCT04250207|147229417|SUPERIORITY|||||||0.5181|||||||Wilcoxon Rank Sum Test|||Week 52||||0.5181
73840696|NCT04250207|147229417|SUPERIORITY|||||||0.1898|||||||Wilcoxon Rank Sum Test|||Week 52||||0.1898
73840697|NCT04250207|147229418|SUPERIORITY|||||||0.0021|||||||Log Rank|||||||0.0021
73840698|NCT04250207|147229418|SUPERIORITY|||||||0.1696|||||||Log Rank|||||||0.1696
73840699|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4872|||||||Chi-square or Fisher exact|||Week 5||||0.4872
73840700|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4634|||||||Chi-square or Fisher exact|||Week 5||||0.4634
73840701|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.605|||||||Chi-square or Fisher exact|||Week 7||||0.6050
73840702|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4762|||||||Chi-square or Fisher exact|||Week 7||||0.4762
73840703|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 9||||> 0.9999
73840704|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 9||||> 0.9999
73840705|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4227|||||||Chi-square or Fisher exact|||Week 12||||0.4227
73840706|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.6796|||||||Chi-square or Fisher exact|||Week 12||||0.6796
73840707|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4642|||||||Chi-square or Fisher exact|||Week 16||||0.4642
73840708|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4645|||||||Chi-square or Fisher exact|||Week 16||||0.4645
73840709|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2744|||||||Chi-square or Fisher exact|||Week 20||||0.2744
73840710|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.7026|||||||Chi-square or Fisher exact|||Week 20||||0.7026
73840711|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.7817|||||||Chi-square or Fisher exact|||Week 24||||0.7817
73840712|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.9285|||||||Chi-square or Fisher exact|||Week 24||||0.9285
73840713|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0135|||||||Chi-square or Fisher exact|||Week 38||||0.0135
73840714|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.6992|||||||Chi-square or Fisher exact|||Week 38||||0.6992
73840715|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0135|||||||Chi-square or Fisher exact|||Week 52||||0.0135
73840716|NCT04250207|147229419|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.5154|||||||Chi-square or Fisher exact|||Week 52||||0.5154
73840717|NCT04250207|147229420|SUPERIORITY|||||||0.1209|||||||Log Rank|||||||0.1209
73840718|NCT04250207|147229420|SUPERIORITY|||||||0.7116|||||||Log Rank|||||||0.7116
73840719|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0915|||||||Chi-square or Fisher exact|||Week 3||||0.0915
73840720|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3282|||||||Chi-square or Fisher exact|||Week 3||||0.3282
73840721|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0648|||||||Chi-square or Fisher exact|||Week 5||||0.0648
73840722|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.031|||||||Chi-square or Fisher exact|||Week 5||||0.0310
73840723|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0187|||||||Chi-square or Fisher exact|||Week 7||||0.0187
73840724|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0036|||||||Chi-square or Fisher exact|||Week 7||||0.0036
73840725|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0687|||||||Chi-square or Fisher exact|||Week 9||||0.0687
73863169|NCT01073930|147272413|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73840726|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0016|||||||Chi-square or Fisher exact|||Week 9||||0.0016
73840727|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0218|||||||Chi-square or Fisher exact|||Week 12||||0.0218
73840728|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0013|||||||Chi-square or Fisher exact|||Week 12||||0.0013
73840729|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0348|||||||Chi-square or Fisher exact|||Week 16||||0.0348
73840730|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1028|||||||Chi-square or Fisher exact|||Week 16||||0.1028
73840731|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.8677|||||||Chi-square or Fisher exact|||Week 20||||0.8677
73840732|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4401|||||||Chi-square or Fisher exact|||Week 20||||0.4401
73840733|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.5926|||||||Chi-square or Fisher exact|||Week 24||||0.5926
73840734|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0732|||||||Chi-square or Fisher exact|||Week 24||||0.0732
73840735|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2497|||||||Chi-square or Fisher exact|||Week 38||||0.2497
73840736|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2453|||||||Chi-square or Fisher exact|||Week 38||||0.2453
73840737|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
73840738|NCT04250207|147229421|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
73840739|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0093|||||||Chi-square or Fisher exact|||Week 3||||0.0093
73840740|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 3||||> 0.9999
73840741|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0006|||||||Chi-square or Fisher exact|||Week 5||||0.0006
73840742|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3449|||||||Chi-square or Fisher exact|||Week 5||||0.3449
73840743|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 7||||0.0028
73840744|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 7||||0.0028
73863170|NCT01073930|147272414|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73863171|NCT01073930|147272415|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73959776|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|10.1||0.4566|ONE_SIDED|95.0|-15.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.6|0.4566
73959777|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|8.9||0.3535|ONE_SIDED|95.0|-11.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.4|0.3535
73863172|NCT01073930|147272416|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73863173|NCT01073930|147272417|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73840745|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0001|||||||Chi-square or Fisher exact|||Week 9||||0.0001
73840746|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 9||||0.0028
73840747|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||<|0.0001|||||||Chi-square or Fisher exact|||Week 12||||< 0.0001
73840748|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 12||||0.0028
73840749|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||<|0.0001|||||||Chi-square or Fisher exact|||Week 16||||< 0.0001
73840750|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0011|||||||Chi-square or Fisher exact|||Week 16||||0.0011
73840751|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0094|||||||Chi-square or Fisher exact|||Week 20||||0.0094
74084240|NCT01525628|147721680|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|381.11|STANDARD_DEVIATION|28.1||1|TWO_SIDED|90.0|317.01|458.19|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||458.19|317.01|1.0000
73840752|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1281|||||||Chi-square or Fisher exact|||Week 20||||0.1281
73840753|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0051|||||||Chi-square or Fisher exact|||Week 24||||0.0051
73840754|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1313|||||||Chi-square or Fisher exact|||Week 24||||0.1313
73840755|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0268|||||||Chi-square or Fisher exact|||Week 38||||0.0268
73840756|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3652|||||||Chi-square or Fisher exact|||Week 38||||0.3652
73840757|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1854|||||||Chi-square or Fisher exact|||Week 52||||0.1854
73840758|NCT04250207|147229422|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
73840759|NCT04250207|147229423|SUPERIORITY|||||||0.0259|||||||Wilcoxon Rank Sum Test|||||||0.0259
73840760|NCT04250207|147229423|SUPERIORITY|||||||0.0068|||||||Wilcoxon Rank Sum Test|||||||0.0068
73840761|NCT04250207|147229424|SUPERIORITY|||||||0.4435|||||||Wilcoxon Rank Sum Test|||Week 1||||0.4435
73840762|NCT04250207|147229424|SUPERIORITY|||||||0.3402|||||||Wilcoxon Rank Sum Test|||Week 1||||0.3402
73840763|NCT04250207|147229424|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 2||||> 0.9999
73840764|NCT04250207|147229424|SUPERIORITY|||||||0.0655|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0655
73840765|NCT04250207|147229424|SUPERIORITY|||||||0.0903|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0903
73840766|NCT04250207|147229424|SUPERIORITY|||||||0.0216|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0216
73840767|NCT04250207|147229424|SUPERIORITY|||||||0.002|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0020
73840768|NCT04250207|147229424|SUPERIORITY|||||||0.0676|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0676
73840769|NCT04250207|147229424|SUPERIORITY|||||||0.0029|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0029
73840770|NCT04250207|147229424|SUPERIORITY|||||||0.0335|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0335
73840771|NCT04250207|147229424|SUPERIORITY|||||||0.0053|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0053
73840772|NCT04250207|147229424|SUPERIORITY|||||||0.0608|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0608
73840773|NCT04250207|147229424|SUPERIORITY|||||||0.0071|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0071
73840774|NCT04250207|147229424|SUPERIORITY|||||||0.4406|||||||Wilcoxon Rank Sum Test|||Week 16||||0.4406
73840775|NCT04250207|147229424|SUPERIORITY|||||||0.1716|||||||Wilcoxon Rank Sum Test|||Week 16||||0.1716
73840776|NCT04250207|147229424|SUPERIORITY|||||||0.9856|||||||Wilcoxon Rank Sum Test|||Week 20||||0.9856
73840777|NCT04250207|147229424|SUPERIORITY|||||||0.2229|||||||Wilcoxon Rank Sum Test|||Week 20||||0.2229
73840778|NCT04250207|147229424|SUPERIORITY|||||||0.8817|||||||Wilcoxon Rank Sum Test|||Week 24||||0.8817
73840779|NCT04250207|147229424|SUPERIORITY|||||||0.2081|||||||Wilcoxon Rank Sum Test|||||||0.2081
74022330|NCT01431287|147597098|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.026||0.0007|TWO_SIDED|95.0|0.037|0.138||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.138|0.037|0.0007
73840780|NCT04250207|147229424|SUPERIORITY|||||||0.7335|||||||Wilcoxon Rank Sum Test|||Week 38||||0.7335
73840781|NCT04250207|147229424|SUPERIORITY|||||||0.5367|||||||Wilcoxon Rank Sum Test|||Week 38||||0.5367
73840782|NCT04250207|147229424|SUPERIORITY|||||||0.555|||||||Wilcoxon Rank Sum Test|||Week 52||||0.5550
73840783|NCT04250207|147229424|SUPERIORITY|||||||0.8718|||||||Wilcoxon Rank Sum Test|||Week 52||||0.8718
73840784|NCT03654326|147229429|SUPERIORITY||Difference in Least Squares Mean|-0.5||||0.066|TWO_SIDED|95.0|-1.01|0.03||Based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|ANCOVA|||||0.03|-1.01|0.066
73840785|NCT03654326|147229430|OTHER|Difference in percentage of participants who experienced one or more adverse events|Difference in % vs Placebo|17.7|||||TWO_SIDED|95.0|3.4|31.3|||||Based on Miettinen \& Nurminen method|||31.3|3.4|
73840786|NCT03654326|147229431|OTHER|Difference in percentage of participants who discontinued study drug due to an adverse event|Difference in % vs Placebo|3.2|||||TWO_SIDED|95.0|-0.9|9.0|||||Based on Miettinen \& Nurminen method|||9.0|-0.9|
73840787|NCT03654326|147229432|OTHER|The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|Difference in Least Squares Mean|-0.6|||||TWO_SIDED|95.0|-1.18|-0.06||||||||-0.06|-1.18|
73840788|NCT03654326|147229433|OTHER|The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|Difference in Least Squares Mean|-0.5|||||TWO_SIDED|95.0|-1.04|0.03||||||||0.03|-1.04|
73840789|NCT00835549|147229460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|94.8|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|94.8|
73840790|NCT00835549|147229461|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.5|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|98.5|
73840791|NCT00835549|147229462|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|98.7|
73840792|NCT00835042|147229463|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.5||||||90.0|85.8|99.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||99.8|85.8|
73840793|NCT00835042|147229464|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|92.2|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|92.2|
73840794|NCT00835042|147229465|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|92.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|92.3|
73840795|NCT00835042|147229466|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|99.3|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111|99.3|
73840796|NCT00835042|147229467|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|96.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|96.4|
73840797|NCT00835042|147229468|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|96.7|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|96.7|
73840798|NCT00835042|147229469|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.0||||||90.0|81.8|101.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101|81.8|
73840799|NCT00835042|147229470|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|94.6|103.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103|94.6|
73840800|NCT00835042|147229471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.6|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||108|97.6|
73840801|NCT00677040|147229497|EQUIVALENCE|t-test to determine if tissue oxygen measurements are equivalent between treated and nontreated breast|t-test|0.35||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
73840802|NCT00677040|147229497|OTHER||t-test|0.35||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||.5
73840803|NCT05524948|147229509|OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.206|<|0.0001|TWO_SIDED|95.0|-1.71|-0.9|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-0.90|-1.71|<0.0001
73840804|NCT05524948|147229510|OTHER||Adjusted Mean Difference|-569.64|STANDARD_ERROR_OF_MEAN|97.479|<|0.0001|TWO_SIDED|95.0|-763.11|-376.17|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-376.17|-763.11|<0.0001
73840805|NCT05524948|147229511|OTHER||Adjusted Mean Difference|-418.86|STANDARD_ERROR_OF_MEAN|64.848|<|0.0001|TWO_SIDED|95.0|-547.56|-290.15|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-290.15|-547.56|<0.0001
73840806|NCT05524948|147229511|OTHER||Adjusted Mean Difference|-108.9|STANDARD_ERROR_OF_MEAN|32.626||0.0012|TWO_SIDED|95.0|-173.66|-44.15|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-44.15|-173.66|0.0012
73840807|NCT05524948|147229511|OTHER||Adjusted Mean Difference|-26.17|STANDARD_ERROR_OF_MEAN|22.909||0.2561|TWO_SIDED|95.0|-71.64|19.29|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||19.29|-71.64|0.2561
73840808|NCT05524948|147229512|OTHER||Adjusted Mean Difference|-721.58|STANDARD_ERROR_OF_MEAN|94.584|<|0.0001|TWO_SIDED|95.0|-909.31|-533.86|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-533.86|-909.31|<0.0001
73840809|NCT05524948|147229513|OTHER||Adjusted Mean Difference|-567.89|STANDARD_ERROR_OF_MEAN|68.09|<|0.0001|TWO_SIDED|95.0|-703.03|-432.75|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-432.75|-703.03|<0.0001
73898491|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|4.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73840810|NCT05524948|147229513|OTHER||Adjusted Mean Difference|-105.39|STANDARD_ERROR_OF_MEAN|24.57|<|0.0001|TWO_SIDED|95.0|-154.15|-56.62|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-56.62|-154.15|<0.0001
73840811|NCT05524948|147229513|OTHER||Adjusted Mean Difference|-38.04|STANDARD_ERROR_OF_MEAN|26.201||0.1498|TWO_SIDED|95.0|-90.04|13.97|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||13.97|-90.04|0.1498
73840812|NCT05524948|147229514|OTHER||Adjusted Mean Difference|-2.17|STANDARD_ERROR_OF_MEAN|0.204|<|0.0001|TWO_SIDED|95.0|-2.58|-1.77|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-1.77|-2.58|<0.0001
73840813|NCT05524948|147229515|OTHER||Adjusted Mean Difference|-396.96|STANDARD_ERROR_OF_MEAN|95.541|<|0.0001|TWO_SIDED|95.0|-586.51|-207.41|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-207.41|-586.51|<0.0001
73840814|NCT05524948|147229516|OTHER||Adjusted Mean Difference|-341.37|STANDARD_ERROR_OF_MEAN|72.446|<|0.0001|TWO_SIDED|95.0|-485.1|-197.64|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-197.64|-485.10|<0.0001
73840815|NCT05524948|147229516|OTHER||Adjusted Mean Difference|-74.15|STANDARD_ERROR_OF_MEAN|20.905||0.0006|TWO_SIDED|95.0|-115.62|-32.68|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-32.68|-115.62|0.0006
73840816|NCT05524948|147229516|OTHER||Adjusted Mean Difference|27.98|STANDARD_ERROR_OF_MEAN|25.942||0.2834|TWO_SIDED|95.0|-23.49|79.45|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||79.45|-23.49|0.2834
74084241|NCT01525628|147721680|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|123.65|STANDARD_DEVIATION|40.0||0.4718|TWO_SIDED|90.0|94.66|161.51|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||161.51|94.66|0.4718
73840817|NCT05524948|147229517|OTHER||Adjusted Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|95.0|-1.83|-1.28|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as the experimental dentifrice minus the reference dentifrice.|||-1.28|-1.83|<0.0001
73840818|NCT05524948|147229518|OTHER||Adjusted Mean Difference|-322.75|STANDARD_ERROR_OF_MEAN|67.778|<|0.0001|TWO_SIDED|95.0|-457.27|-188.23|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-188.23|-457.27|<0.0001
73840819|NCT05524948|147229519|OTHER||Adjusted Mean Difference|-250.33|STANDARD_ERROR_OF_MEAN|42.838|<|0.0001|TWO_SIDED|95.0|-335.35|-165.3|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-165.30|-335.35|<0.0001
73840820|NCT05524948|147229519|OTHER||Adjusted Mean Difference|-45.53|STANDARD_ERROR_OF_MEAN|23.439||0.055|TWO_SIDED|95.0|-92.05|0.99|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||0.99|-92.05|0.0550
73840821|NCT05524948|147229519|OTHER||Adjusted Mean Difference|-32.68|STANDARD_ERROR_OF_MEAN|26.036||0.2124|TWO_SIDED|95.0|-84.36|18.99|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||18.99|-84.36|0.2124
73840822|NCT05524948|147229520|OTHER||Adjusted Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.164|<|0.0001|TWO_SIDED|95.0|-1.52|-0.87|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-0.87|-1.52|<0.0001
73840823|NCT05155085|147229521|SUPERIORITY||Risk Difference (RD)|5.1||||0.4662|TWO_SIDED|95.0|-9.8|19.8|||Cochran-Mantel-Haenszel|||||19.8|-9.8|0.4662
73840824|NCT05155085|147229522|SUPERIORITY||LSM Difference from Placebo|-9.7|STANDARD_ERROR_OF_MEAN|11.4||0.3968|TWO_SIDED|95.0|-32.2|12.9|||Mixed Models Analysis|||||12.9|-32.2|0.3968
73840825|NCT05155085|147229523|SUPERIORITY||Risk Difference (RD)|3.3||||0.7625|TWO_SIDED|95.0|-15.2|21.6|||Fisher Exact|||||21.6|-15.2|0.7625
73840826|NCT03715829|147229538|SUPERIORITY||Least Squares Mean Difference (Net)|-23.2|STANDARD_ERROR_OF_MEAN|5.62|<|0.0001|TWO_SIDED|90.0|-32.53|-13.96||Hochberg's step-up procedure was conducted to compare ritlecitinib 200mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-13.96|-32.53|<0.0001
73840827|NCT03715829|147229538|SUPERIORITY||Least Squares Mean Difference (Net)|-23.2|STANDARD_ERROR_OF_MEAN|5.63|<|0.0001|TWO_SIDED|90.0|-32.53|-13.93||Hochberg's step-up procedure was conducted to compare ritlecitinib 100mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-13.93|-32.53|<0.0001
73840828|NCT03715829|147229538|SUPERIORITY||Least Squares Mean Difference (Net)|-20.6|STANDARD_ERROR_OF_MEAN|5.84||0.0003|TWO_SIDED|90.0|-30.23|-10.93||Hochberg's step-up procedure was conducted to compare the ritlecitinib 50 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-10.93|-30.23|0.0003
73840829|NCT03715829|147229538|SUPERIORITY||Least Squares Mean Difference (Net)|-16.7|STANDARD_ERROR_OF_MEAN|6.71||0.0068|TWO_SIDED|90.0|-27.77|-5.61||Hochberg's step-up procedure was conducted to compare the ritlecitinib 30 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.|ANCOVA|||||-5.61|-27.77|0.0068
73840830|NCT03715829|147229538|SUPERIORITY||Least Squares Mean Difference (Net)|-5.1|STANDARD_ERROR_OF_MEAN|6.03||0.2015|TWO_SIDED|90.0|-15.02|4.91||Hochberg's step-up procedure was conducted to compare the ritlecitinib 10 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.|ANCOVA|||||4.91|-15.02|0.2015
73840831|NCT00855166|147229585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.3885|<|0.0001|TWO_SIDED|95.0|-2.84|-1.31||Significant at alpha=0.05 (2-sided)|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.31|-2.84|<0.0001
73840832|NCT00855166|147229586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.6162||0.0143|TWO_SIDED|95.0|-2.74|-0.31||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.31|-2.74|0.0143
73840833|NCT00855166|147229587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.3731||0.0001|TWO_SIDED|95.0|-2.22|-0.74||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.74|-2.22|0.0001
73840834|NCT00855166|147229588|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.3|STANDARD_ERROR_OF_MEAN|5.309|<|0.0001|TWO_SIDED|95.0|15.9|36.7||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum (gender).||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||36.7|15.9|<0.0001
73863174|NCT01073930|147272418|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73863175|NCT01266590|147272423|SUPERIORITY_OR_OTHER|||||||0.0664||95.0|||||Wilcoxon Signed Rank|||||||0.0664
73840835|NCT00855166|147229589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.5652||0.7013|TWO_SIDED|95.0|-0.89|1.34||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||1.34|-0.89|0.7013
73840836|NCT00855166|147229590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.6473||0.1521|TWO_SIDED|95.0|-2.21|0.35||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||0.35|-2.21|0.1521
73840837|NCT00855166|147229591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.4428||0.3105|TWO_SIDED|95.0|-1.32|0.43||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||0.43|-1.32|0.3105
73840838|NCT01854762|147229594|OTHER||Odds Ratio (OR)|3.1|||<|0.01|TWO_SIDED|95.0|1.3|7.4|||Fisher Exact||||Kaplan-Meier estimates for the proportion of patients without virological failure by weeks 2, 4 and 6, and at delivery, using treatment-related discontinuation equal failure analysis|7.4|1.3|<0.01
73840839|NCT02181413|147229632|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.582|0.89|||Log Rank|P-value was based on log-rank test stratified by pre-induction regimen, International Staging System (ISS) stage and response after transplantation.|HR was based on Cox's proportional hazard regression model stratified by pre-induction regimen, pre-induction ISS stage and response after transplantation. \<1 HR indicates better prevention of progression in Ixazomib arm compared to Placebo.|||0.890|0.582|0.002
73840840|NCT02181413|147229633|SUPERIORITY||Hazard Ratio (HR)|1.025||||0.85|TWO_SIDED|95.0|0.789|1.332||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.332|0.789|0.850
73840841|NCT02181413|147229634|SUPERIORITY||Odds Ratio (OR)|0.732||||0.37|TWO_SIDED|95.0|0.365|1.466||P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by pre-induction regimen, pre-induction international staging system (ISS), and response after transplantation at screening.|Cochran-Mantel-Haenszel||Odds ratio and CI are based on a logistic regression model with treatment group as a categorical predictor variable and pre-induction regimen, pre-induction ISS, and response after transplantation at screening as covariates.|CR||1.466|0.365|0.370
73840842|NCT02181413|147229635|SUPERIORITY||Hazard Ratio (HR)|0.716||||0.002|TWO_SIDED|95.0|0.579|0.886||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||0.886|0.579|0.002
73840843|NCT02181413|147229636|SUPERIORITY||Hazard Ratio (HR)|1.015||||0.902|TWO_SIDED|95.0|0.795|1.298||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.298|0.795|0.902
73840844|NCT02181413|147229637|SUPERIORITY||Hazard Ratio (HR)|0.833||||0.056|TWO_SIDED|95.0|0.69|1.005|||Log Rank|P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.005|0.690|0.056
74084242|NCT01525628|147721681|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|306.45|STANDARD_DEVIATION|30.7||1|TWO_SIDED|90.0|250.93|374.26|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||374.26|250.93|1.0000
73840845|NCT02181413|147229638|SUPERIORITY||Hazard Ratio (HR)|0.922||||0.431|TWO_SIDED|95.0|0.753|1.129||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage, and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.129|0.753|0.431
73840846|NCT02181413|147229639|SUPERIORITY||Hazard Ratio (HR)|1.179|||||TWO_SIDED|95.0|0.959|1.45|||||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.450|0.959|
73840847|NCT02181413|147229641|SUPERIORITY|||||||0.814||||||P-value was based on Fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.|Fisher Exact|||||||0.814
73840848|NCT02181413|147229642|SUPERIORITY|||||||0.805||||||P-value was based on fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.|Fisher Exact|||||||0.805
73840849|NCT02181413|147229643|SUPERIORITY||Hazard Ratio (HR)|0.612||||0.034|TWO_SIDED|95.0|0.386|0.969||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD- at Study Entry||0.969|0.386|0.034
73840850|NCT02181413|147229643|SUPERIORITY||Hazard Ratio (HR)|0.704||||0.01|TWO_SIDED|95.0|0.539|0.92||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD+ at Study Entry||0.920|0.539|0.010
73840851|NCT02181413|147229644|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.182|TWO_SIDED|95.0|0.414|1.184||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD- at Study Entry||1.184|0.414|0.182
73840852|NCT02181413|147229644|SUPERIORITY||Hazard Ratio (HR)|0.966||||0.847|TWO_SIDED|95.0|0.682|1.368||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD+ at Study Entry||1.368|0.682|0.847
73840853|NCT02181413|147229645|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.905|TWO_SIDED|95.0|0.583|1.613||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.613|0.583|0.905
73840854|NCT02181413|147229650|SUPERIORITY||Least Squares (LS) Mean Difference|-2.3||||0.074|TWO_SIDED|95.0|-4.9|0.2|||t-test, 2 sided|P-value was from the significance test for the coefficient of the interaction between treatment and visit.||||0.2|-4.9|0.074
74022331|NCT01431287|147597098|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.043|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.144|0.043|0.0003
74022332|NCT01431287|147597098|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.026||0.003|TWO_SIDED|95.0|0.026|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.127|0.026|0.0030
74022333|NCT01431287|147597098|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.026||0.5159|TWO_SIDED|95.0|-0.034|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.068|-0.034|0.5159
74022334|NCT01431287|147597099|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.159|0.261||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.261|0.159|<0.0001
74022335|NCT01431287|147597099|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.089|STANDARD_ERROR_OF_MEAN|0.026||0.0006|TWO_SIDED|95.0|0.038|0.141||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.141|0.038|0.0006
73840855|NCT02514746|147229654|OTHER||Difference (Group A - B)|-0.6|||||TWO_SIDED|95.0|-7.5|4.5||||||Difference at Year 3||4.5|-7.5|
73898492|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|0.9|STANDARD_ERROR_OF_MEAN|0.499||0.073|TWO_SIDED|95.0|-0.085|1.879||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.879|-0.085|0.073
74022336|NCT01431287|147597099|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.234|0.132|<0.0001
74022337|NCT01431287|147597099|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.026||0.0094|TWO_SIDED|95.0|0.017|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.119|0.017|0.0094
73840856|NCT02514746|147229654|OTHER||Difference (Group A - B)|0.6|||||TWO_SIDED|95.0|-7.4|6.5||||||Difference at Year 4||6.5|-7.4|
73840857|NCT02514746|147229655|OTHER||GMT Ratio (Group A/B)|1.0|||||TWO_SIDED|95.0|0.9|1.1||||||Geometric mean titer ratio at Year 3||1.1|0.9|
73840858|NCT02514746|147229655|OTHER||GMT Ratio (Group A/B)|1.0|||||TWO_SIDED|95.0|0.9|1.1||||||Geometric mean titer ratio at Year 4||1.1|0.9|
73840859|NCT02514746|147229656|OTHER||Difference (Group A - B)|-3.7|||||TWO_SIDED|95.0|-8.1|2.8||||||Difference at 7 days post booster vaccination||2.8|-8.1|
73840860|NCT02514746|147229656|OTHER||Difference (Group A - B)|-1.3|||||TWO_SIDED|95.0|-3.3|3.0||||||Difference at 28 days post booster vaccination||3.0|-3.3|
73840861|NCT02514746|147229657|OTHER||GMT Ratio (Group A/B)|0.7|||||TWO_SIDED|95.0|0.5|1.0||||||Geometric mean titer ratio 7 days after booster dose||1.0|0.5|
73840862|NCT02514746|147229657|OTHER||GMT Ratio (Group A/B)|0.7|||||TWO_SIDED|95.0|0.6|0.9||||||Geometric mean titer ratio 28 days after booster dose||0.9|0.6|
73840863|NCT02514746|147229658|OTHER||Difference (Group A - B)|-2.9|||||TWO_SIDED|95.0|-8.0|4.5||||||Difference at 7 days post booster vaccination||4.5|-8.0|
73840864|NCT02514746|147229658|OTHER||Difference (Group A - B)|-1.8|||||TWO_SIDED|95.0|-4.4|3.0||||||Difference at 28 days post booster vaccination||3.0|-4.4|
73840865|NCT03555994|147229672|SUPERIORITY||Least square mean difference|-105.7||||0.023||90.0|-178.8|-32.6|||ANCOVA|||||-32.6|-178.8|0.023
73840866|NCT03555994|147229673|SUPERIORITY||Least square mean difference|-25.87||||0.008||90.0|-40.88|-10.86|||ANCOVA|||||-10.86|-40.88|0.008
73840867|NCT03555994|147229674|SUPERIORITY||Least Square Mean difference|-21.99||||0.008||90.0|-34.55|-9.43|||ANCOVA|||||-9.43|-34.55|0.008
73840868|NCT03555994|147229675|SUPERIORITY||Least Square Mean difference|-35.06||||0.07||90.0|-66.54|-3.58|||ANCOVA|||||-3.58|-66.54|0.070
73840869|NCT03555994|147229675|SUPERIORITY||Least Square Mean difference|-11.72||||0.03||90.0|-20.13|-3.3|||ANCOVA|||||-3.30|-20.13|0.030
73840870|NCT01111552|147229710|SUPERIORITY||Treatment Difference|-1.3|||=|0.595|TWO_SIDED|95.0|-5.9|3.4|||ANCOVA|||||3.4|-5.9|=0.595
73840871|NCT01111552|147229710|SUPERIORITY||Treatment Difference|0.4|||=|0.869|TWO_SIDED|95.0|-4.4|5.1|||ANCOVA|||||5.1|-4.4|=0.869
73840872|NCT01111552|147229711|SUPERIORITY||Treatment Difference|-0.1|||=|0.856|TWO_SIDED|95.0|-0.7|0.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.6|-0.7|=0.856
73840873|NCT01111552|147229711|SUPERIORITY||Treatment Difference|0.1|||=|0.838|TWO_SIDED|95.0|-0.6|0.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.7|-0.6|=0.838
73840874|NCT01111552|147229712|SUPERIORITY||Treatment Difference|-0.2|||=|0.765|TWO_SIDED|95.0|-1.6|1.2|||ANCOVA|||||1.2|-1.6|=0.765
73840875|NCT01111552|147229712|SUPERIORITY||Treatment Difference|0.2|||=|0.76|TWO_SIDED|95.0|-1.2|1.6|||ANCOVA|||||1.6|-1.2|=0.760
73840876|NCT03829514|147229750|OTHER|||||||0.05|||||||t-test, 2 sided|Signal intensity data were loess normalized and normalized data were used to perform a limma t-test with empirical Bayes smoothing to standard errors|||Proteins were identified and quantified using EncyclopeDIA and visualized with Scaffold DIA using 1% false discovery thresholds at both the protein and peptide level. Protein exclusive intensity values were assessed for quality using an in-house ProteiNorm app, a tool for systematic evaluation of normalization methods, imputation of missing values and comparisons of multiple differential abundance methods . Cyclic loess normalization. The normalized data were used to perform statistical analysis using linear models for microarray data (limma) with empirical Bayes (eBayes) smoothing to the standard errors. Proteins with p-value \< 0.05 were considered significant.|||0.05
73840877|NCT01339091|147229751|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|1.5|||||TWO_SIDED|95.0|-4.6|7.9|||||Confidence intervals were adjusted for fever at baseline|||7.9|-4.6|
73840878|NCT01557569|147229763|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.413|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||Due to skewed data, Kruskal Wallis Test was used.||||<0.05
73840879|NCT02500836|147229768|SUPERIORITY||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||<0.0001
73840880|NCT02500836|147229769|SUPERIORITY||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||<0.0001
73840881|NCT01220687|147229788|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.0012|TWO_SIDED||||||t-test, 2 sided|||||||0.0012
73840882|NCT01220687|147229789|SUPERIORITY||Rate Ratio|1.91|||<|0.0001|TWO_SIDED|95.0|1.68|2.18|||Poisson|||||2.18|1.68|<0.0001
73840883|NCT03647137|147229819|OTHER||Standardized β Coefficient|-2.256||||0.00468|TWO_SIDED|||||The p-value is derived from model comparison between the FEOVB model and the FEOVB\*PIB interaction model.|ChiSq Goodness of Fit Test|||L-DOPA sensitivity outcome measure was modeled with 3-level hierarchical ordinal logistic regression. The null model contained only striatal DTBZ as predictor of group, the FEOVB model additionally had FEOVB tracer, and interaction model had in addition an interaction term between FEOVB and PIB tracer. Model comparisons were performed using Chi-Square goodness of fit test.||||0.00468
73840884|NCT03253627|147229832|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||baseline||||0.460
73840885|NCT03253627|147229832|SUPERIORITY|||||||0.896|||||||t-test, 2 sided|||3 months||||0.896
73840886|NCT03253627|147229833|SUPERIORITY|||||||0.374|||||||t-test, 2 sided|||baseline||||0.374
73840887|NCT03253627|147229833|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||6 months||||0.236
73840888|NCT03253627|147229834|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||baseline||||0.180
73840889|NCT03253627|147229834|SUPERIORITY|||||||0.822|||||||t-test, 2 sided|||6 months||||0.822
73840890|NCT03253627|147229835|SUPERIORITY|||||||0.715|||||||t-test, 2 sided|||baseline||||.715
73840891|NCT03253627|147229835|SUPERIORITY|||||||0.861|||||||t-test, 2 sided|||3 months||||0.861
73840892|NCT03253627|147229835|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||6 months||||.790
73840893|NCT03253627|147229836|SUPERIORITY|||||||0.452|||||||t-test, 2 sided|||baseline||||0.452
73840894|NCT03253627|147229836|SUPERIORITY|||||||0.253|||||||t-test, 2 sided|||3 months||||0.253
73840895|NCT03253627|147229836|SUPERIORITY|||||||0.469|||||||t-test, 2 sided|||6 months||||0.469
73840896|NCT03253627|147229837|SUPERIORITY|||||||0.628|||||||t-test, 2 sided|||baseline||||0.628
73840897|NCT03253627|147229837|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||3 months||||0.345
73840898|NCT03253627|147229837|SUPERIORITY|||||||0.384|||||||t-test, 2 sided|||6 months||||0.384
73840899|NCT03253627|147229838|SUPERIORITY|||||||0.398|||||||t-test, 2 sided|||baseline||||.398
73840900|NCT03253627|147229838|SUPERIORITY|||||||0.811|||||||t-test, 2 sided|||3 months||||0.811
73840901|NCT03253627|147229838|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||6 months||||0.027
73840902|NCT01603368|147229854|OTHER|Student's t-test|||||=|0.001|||||||t-test, 2 sided|||||||=0.001
73840903|NCT01916226|147229884|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|-0.3||0.278|TWO_SIDED|95.0|-0.7|0.2||Estimating the standard deviation of CFB in rTNSS over 2 weeks to be approximately 2.6, a two-sample t-test with α=0.05 suggests that a sample size of 144 participants per arm would provide 90% power to show a difference of 1.0 between treatments.|ANCOVA|||||0.2|-0.7|0.278
73840904|NCT03163667|147229891|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.07905|TWO_SIDED|95.0|0.34|1.2||One-sided p-value comparing the treatment groups was based on a stratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CB-839+Everolimus (CBE), and a hazard ratio \> 1 favors Placebo+Everolimus (PboE).|Stratified analysis. Stratification factors were Memorial Sloan Kettering Cancer Center (MSKCC) Prognostic Risk (favorable versus intermediate/poor risk) and number of prior therapies with a tyrosine kinase inhibitor (TKI; 1 versus \> 1). Due to stratification cells having \< 10 events, TKI stratification factor was removed for analysis.||1.20|0.34|0.07905
73840905|NCT03163667|147229891|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.1184|TWO_SIDED|95.0|0.37|1.28||One-sided p-value comparing the treatment groups was based on an unstratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Unstratified analysis||1.28|0.37|0.1184
73840906|NCT03163667|147229892|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.4801|TWO_SIDED|95.0|0.42|1.5||P-value comparing the treatment groups is based on a stratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Stratified analysis: Stratification factors are MSKCC Prognostic Risk (favorable vs intermediate/poor risk) and number of prior therapies with a TKI (1 vs \> 1). Due to stratification cells having \< 10 events, TKI stratification factor was removed for analysis.||1.50|0.42|0.4801
73840907|NCT03163667|147229892|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.5603|TWO_SIDED|95.0|0.44|1.56||P-value comparing the treatment groups is based on an unstratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Unstratified analysis||1.56|0.44|0.5603
73840908|NCT05430919|147229893|SUPERIORITY||Least Squares (LS) Mean Difference|-2.31|||<|0.0001|TWO_SIDED|95.0|-3.229|-1.385|||ANCOVA||REGN5713-5714-5715 900 mg vs. Placebo, Day 29|||-1.385|-3.229|<0.0001
73840909|NCT05430919|147229894|SUPERIORITY||LS Mean Difference|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.634|-1.658|||ANCOVA||REGN5713-5715 600 mg vs. Placebo, Day 29|||-1.658|-3.634|<0.0001
73840910|NCT05430919|147229894|SUPERIORITY||LS Mean Difference|-1.51||||0.0023|TWO_SIDED|95.0|-2.478|-0.539|||ANCOVA||REGN5715 300 mg vs. Placebo, Day 29|||-0.539|-2.478|0.0023
73840911|NCT05430919|147229910|SUPERIORITY||LS Mean Difference|-63.18|||<|0.0001|TWO_SIDED|95.0|-73.411|-52.95|||ANCOVA||REGN5713-5714-5715 900 mg vs. Placebo, Day 29|||-52.950|-73.411|<0.0001
73840912|NCT05430919|147229910|SUPERIORITY||LS Mean Difference|-56.01|||<|0.0001|TWO_SIDED|95.0|-66.806|-45.204|||ANCOVA||REGN5713-5715 600 mg vs. Placebo, Day 29|||-45.204|-66.806|<0.0001
73840913|NCT05430919|147229910|SUPERIORITY||LS Mean Difference|-34.82|||<|0.0001|TWO_SIDED|95.0|-45.304|-24.343|||ANCOVA||REGN5715 300 mg vs. Placebo, Day 29|||-24.343|-45.304|<0.0001
73840914|NCT02702999|147229942|SUPERIORITY||Risk Ratio (RR)|3.9|||||TWO_SIDED|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||18.0|0.9|
73840915|NCT02702999|147229943|SUPERIORITY||Risk Ratio (RR)|3.9|||||TWO_SIDED|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||18.0|0.9|
73840916|NCT02702999|147229944|SUPERIORITY||Risk Ratio (RR)|1.9|||||TWO_SIDED|95.0|0.4|10.5|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||10.5|0.4|
73840917|NCT02702999|147229945|SUPERIORITY||Risk Ratio (RR)|5.4|||||TWO_SIDED|95.0|1.2|23.7|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||23.7|1.2|
73840918|NCT02702999|147229946|SUPERIORITY||Risk Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.03|2.1|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||2.1|0.03|
73840919|NCT02702999|147229947|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.4|2.3|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||2.3|0.4|
73840920|NCT01813357|147229964|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.684|TWO_SIDED||||||Mixed Models Analysis|||||||0.684
73840921|NCT03773562|147229966|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Responders vs Non-responders||||0.04
73840922|NCT03773562|147229968|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Responders vs Non-Responders||||0.002
73840923|NCT03773562|147229969|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Responders vs Non-responders||||0.01
73840924|NCT03773562|147229971|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
73840925|NCT03773562|147229972|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
73840926|NCT03773562|147229973|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
73840927|NCT03773562|147229974|SUPERIORITY|||||||0.0033|||||||t-test, 2 sided|||Responder vs non-responder||||0.0033
73840928|NCT03773562|147229975|SUPERIORITY|||||||0.0041|||||||t-test, 2 sided|||Responder vs non-responder||||0.0041
73840929|NCT03773562|147229976|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Responder vs non-responder||||0.0046
73840930|NCT03131479|147229977|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-9.21||||0.154|TWO_SIDED|90.0|-19.88|1.45|||Regression, Logistic|An unstructured variance-covariance structure was used. Baseline is defined to be the measurement collected on Day -1.||||1.45|-19.88|0.154
73840931|NCT03131479|147229977|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-6.05||||0.343|TWO_SIDED|90.0|-16.65|4.55|||Regression, Logistic|||||4.55|-16.65|0.343
73840932|NCT03131479|147229977|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-21.5||||0.001|TWO_SIDED|90.0|-31.79|4.55|||Regression, Logistic|||||4.55|-31.79|0.001
73840933|NCT03131479|147229977|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-35.6||||0|TWO_SIDED|90.0|-46.0|-25.11|||Regression, Logistic|||||-25.11|-46.00|0.000
74084243|NCT01525628|147721681|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|129.85|STANDARD_DEVIATION|32.5||0.6185|TWO_SIDED|90.0|104.26|161.71|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||161.71|104.26|0.6185
74084244|NCT01525628|147721682|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|286.01|STANDARD_DEVIATION|39.4||1|TWO_SIDED|90.0|228.51|357.97|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||357.97|228.51|1.0000
73840934|NCT01272219|147229987|SUPERIORITY_OR_OTHER||Estimated mean difference|-5.39|||<|0.0001|TWO_SIDED|95.0|-5.82|-4.95|||ANCOVA||ANCOVA model with treatment, country, sex, pre-diabetes status at screening, baseline BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss, if the estimated treatment effect (liraglutide 3.0 mg - liraglutide placebo) was statistically significantly smaller than zero.||-4.95|-5.82|<0.0001
73840935|NCT01272219|147229988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|4.12|5.6|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing ≥5% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.||5.60|4.12|<0.0001
73840936|NCT01272219|147229989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.34|||<|0.0001|TWO_SIDED|95.0|3.54|5.32|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing \>10% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.||5.32|3.54|<0.0001
73840937|NCT01272219|147229990|SUPERIORITY_OR_OTHER||Treatment estimate|2.681|||<|0.0001|TWO_SIDED|95.0|1.856|3.872|||Weibull analysis||The treatment estimate was the factor that the time to event is multiplied with for liraglutide 3.0 mg compared to placebo.|If the estimated time-to-event ratio (liraglutide 3.0 mg/ placebo), as assessed by the survival endpoint describing the time until onset of T2DM ('diabetes-free time'), is statistically significantly \>1, then liraglutide 3.0 mg was to be considered superior to placebo in delaying the onset of T2DM in subjects with pre-diabetes at baseline. Weibull model was used; included treatment, sex and BMI stratification factor as fixed factors and baseline FPG as a covariate.||3.872|1.856|<.0001
73898493|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|4.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73840938|NCT04806373|147230008|OTHER|||||||0.863|||||||Fisher Exact|||||||0.863
73840939|NCT04806373|147230009|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Difference in pleural drainage volume day 1 post-TSP||||0.005
73840940|NCT04806373|147230010|OTHER|||||||0.891|||||||Wilcoxon (Mann-Whitney)|||Borg dyspnea scale day 3 post-TSP||||0.891
73840941|NCT04806373|147230011|OTHER|||||||0.899|||||||Wilcoxon (Mann-Whitney)|||Pain score at day 3 post-TSP||||0.899
73840942|NCT04806373|147230012|OTHER|||||||0.809|||||||Fisher Exact|||||||0.809
73840943|NCT04806373|147230013|OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
73840944|NCT04806373|147230014|OTHER|||||||0.808|||||||Wilcoxon (Mann-Whitney)|||||||0.808
73840945|NCT04806373|147230015|OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
73840946|NCT04806373|147230016|OTHER|||||||0.714|||||||t-test, 2 sided|||||||0.714
73840947|NCT04806373|147230017|OTHER|||||||1|||||||Fisher Exact|||||||1.0
73840948|NCT02214212|147230021|SUPERIORITY||Slope|-0.16||||0.955|TWO_SIDED|95.0|-5.69|5.37|||Mixed Models Analysis|Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects.|The reported effect size has been expressed as the modelled difference in sleep efficiency improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.|||5.37|-5.69|.955
73840949|NCT02214212|147230022|SUPERIORITY||Mean Difference (Net)|0.69||||0.807|TWO_SIDED|95.0|-4.9|6.29|||Mixed Models Analysis|||||6.29|-4.90|.807
73840950|NCT02214212|147230023|SUPERIORITY||Mean Difference (Net)|-0.48||||0.847|TWO_SIDED|95.0|-5.38|4.43|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.||||4.43|-5.38|.847
73840951|NCT02214212|147230024|SUPERIORITY||Mean Difference (Net)|3.14||||0.252|TWO_SIDED|95.0|-2.29|8.56|||Mixed Models Analysis|Statistical significance by mixed-effects regression adjusts for time (pre/post), site, FIM admit cognitive, FIM admit motor as fixed effects.||||8.56|-2.29|.252
73840952|NCT02214212|147230025|SUPERIORITY||Mean Difference (Net)|0.67||||0.722|TWO_SIDED|95.0|-3.08|4.4|||Mixed Models Analysis|||||4.4|-3.08|.722
73840953|NCT02214212|147230026|SUPERIORITY||Mean Difference (Net)|-2.25||||0.253|TWO_SIDED|95.0|-6.13|1.64|||Mixed Models Analysis|||||1.64|-6.13|.253
73840954|NCT02214212|147230027|SUPERIORITY||Mean Difference (Net)|-0.39||||0.351|TWO_SIDED|95.0|-1.21|0.44|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.|A positive effect size indicates a higher score in the bright white light (BWL) intervention arm.|||0.44|-1.21|.351
74022338|NCT01431287|147597099|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.026||0.0174|TWO_SIDED|95.0|0.011|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.011|0.0174
73840955|NCT02214212|147230028|SUPERIORITY||Slope|0.0||||0.91|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects|The reported effect size has been expressed as the modelled difference in the Makley scale score improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.|||0.03|-0.03|.910
73840956|NCT02214212|147230029|SUPERIORITY||Mean Difference (Net)|0.857||||0.19|TWO_SIDED|95.0|-1.93|2.32|||Mixed Models Analysis|Mixed-effects model adjusts for treatment time (pre/post)||||2.32|-1.93|0.19
73840957|NCT02214212|147230030|SUPERIORITY||Mean Difference (Net)|-4.8||||0.345|TWO_SIDED|95.0|-14.83|5.24|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), FIM admit cognitive, site, FIM admit motor as mixed effects.||||5.24|-14.83|.345
73840958|NCT04903093|147230047|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|96.96|||||TWO_SIDED|90.0|85.43|110.03||||||Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet||110.03|85.43|
73898494|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.487||0.517|TWO_SIDED|95.0|-0.641|1.273||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 48||1.273|-0.641|0.517
74022339|NCT01431287|147597099|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.026||0.2888|TWO_SIDED|95.0|-0.023|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.079|-0.023|0.2888
73840959|NCT04903093|147230047|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio (%) of adjusted geometric means|62.87|||||TWO_SIDED|90.0|54.85|72.07||||||Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commecial tablet; Reference: Abrocitinib 200 mg commercial tablet||72.07|54.85|
73840960|NCT04903093|147230048|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|100.07|||||TWO_SIDED|90.0|80.28|124.74||||||Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet||124.74|80.28|
73840961|NCT04903093|147230048|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|15.53|||||TWO_SIDED|90.0|12.46|19.36||||||Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commercial tablet; Reference: Abrocitinib 200 mg commercial tablet||19.36|12.46|
73840962|NCT00057577|147230083|SUPERIORITY_OR_OTHER||||||=|0.038|TWO_SIDED||||||Subdistribution hazard model|||||||=.038
73840963|NCT00057577|147230084|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Subdistribution hazard model|||||||<0.01
73840964|NCT01852214|147230098|SUPERIORITY_OR_OTHER|||||||0.022|||||||Mixed Models Analysis|||||||0.022
73840965|NCT01852214|147230099|SUPERIORITY_OR_OTHER|||||||0.086|||||||Mixed Models Analysis|||||||0.086
73840966|NCT02691494|147230119|SUPERIORITY||Odds Ratio (OR)|28.73|||<|0.001|TWO_SIDED|95.0|12.248|67.387||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||67.387|12.248|< 0.001
73840967|NCT02691494|147230119|SUPERIORITY||Odds Ratio (OR)|28.31|||<|0.001|TWO_SIDED|95.0|13.042|61.431||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||61.431|13.042|< 0.001
73840968|NCT02691494|147230120|SUPERIORITY||LS Mean of Difference|-194.5|STANDARD_ERROR_OF_MEAN|21.7|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
73840969|NCT02691494|147230120|SUPERIORITY||LS Mean of Difference|-164.6|STANDARD_ERROR_OF_MEAN|18.87|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
73840970|NCT02691494|147230121|SUPERIORITY||Between-Group Difference (%)|84.2|||<|0.001|TWO_SIDED|95.0|75.99|92.37||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||92.37|75.99|< 0.001
73840971|NCT02691494|147230121|SUPERIORITY||Between-Group Difference (%)|56.3|||<|0.001|TWO_SIDED|95.0|47.77|64.91||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||64.91|47.77|< 0.001
73840972|NCT02691494|147230122|SUPERIORITY||LS Mean of Difference|-252.3|STANDARD_ERROR_OF_MEAN|24.53|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73840973|NCT02691494|147230122|SUPERIORITY||LS Mean of Difference|-226.6|STANDARD_ERROR_OF_MEAN|20.5|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73840974|NCT02691494|147230123|SUPERIORITY||LS Mean of Difference|-196.9|STANDARD_ERROR_OF_MEAN|16.66|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73840975|NCT02691494|147230123|SUPERIORITY||LS Mean of Difference|-186.1|STANDARD_ERROR_OF_MEAN|14.18|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73840976|NCT02691494|147230124|SUPERIORITY||Between-Group Difference (%)|19.2||||0.146|TWO_SIDED|95.0|-5.99|44.32||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||44.32|-5.99|0.146
73840977|NCT02691494|147230124|SUPERIORITY||Between-Group Difference (%)|29.2||||0.017|TWO_SIDED|95.0|7.62|50.71||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||50.71|7.62|0.017
73840978|NCT02691494|147230125|SUPERIORITY||LS Mean of Difference|-194.5|STANDARD_ERROR_OF_MEAN|20.56|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73898495|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898496|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|0.38|STANDARD_ERROR_OF_MEAN|0.501||0.454|TWO_SIDED|95.0|-0.609|1.36||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.360|-0.609|0.454
73840979|NCT02691494|147230125|SUPERIORITY||LS Mean of Difference|-125.0|STANDARD_ERROR_OF_MEAN|17.55|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73840980|NCT02613507|147230156|SUPERIORITY|||||||0.0006|TWO_SIDED|||||The boundary for statistical significance requires the p-value to be less than 0.0231|Stratified weighted Log-Rank|Stratified weighted using G \[rho=0, gamma=1\] Fleming and Harrington.||||||0.0006
73840981|NCT02613507|147230156|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|97.7|0.52|0.9|||Stratified Cox Proportional Hazard Model|||||0.90|0.52|
73840982|NCT02613507|147230156|SUPERIORITY|||||||0.0017|||||||Log Rank|regular stratified log-rank test p-value||||||0.0017
73840983|NCT03941093|147230166|OTHER||Hazard Ratio (HR)|1.08||||0.5487|TWO_SIDED|95.0|0.83|1.41|||Stratified Log Rank Test|||||1.41|0.83|0.5487
73840984|NCT00561821|147230182|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73840985|NCT00561821|147230182|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73840986|NCT00561821|147230182|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73840987|NCT00561821|147230183|SUPERIORITY_OR_OTHER|||||||0.0146||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0146
73840988|NCT00561821|147230183|SUPERIORITY_OR_OTHER|||||||0.0234||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0234
73840989|NCT00561821|147230183|SUPERIORITY_OR_OTHER|||||||0.0102||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0102
73840990|NCT00561821|147230184|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73840991|NCT00561821|147230184|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73840992|NCT00561821|147230184|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73840993|NCT00561821|147230185|SUPERIORITY_OR_OTHER|||||||0.001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.001
73840994|NCT00561821|147230185|SUPERIORITY_OR_OTHER|||||||0.0213||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0213
73840995|NCT00561821|147230185|SUPERIORITY_OR_OTHER|||||||0.0135||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0135
73840996|NCT00561821|147230186|SUPERIORITY_OR_OTHER|||||||0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0001
73840997|NCT00561821|147230186|SUPERIORITY_OR_OTHER|||||||0.0003||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0003
73840998|NCT00561821|147230186|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73840999|NCT00561821|147230187|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841000|NCT00561821|147230187|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841001|NCT00561821|147230187|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841002|NCT00561821|147230188|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841003|NCT00561821|147230188|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841004|NCT00561821|147230188|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841005|NCT00561821|147230189|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841006|NCT00561821|147230189|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841007|NCT00561821|147230189|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841008|NCT00561821|147230190|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841009|NCT00561821|147230190|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841010|NCT00561821|147230190|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841011|NCT00561821|147230191|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841012|NCT00561821|147230191|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841013|NCT00561821|147230191|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841014|NCT00561821|147230192|SUPERIORITY_OR_OTHER|||||||0.6317||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6317
73841015|NCT00561821|147230192|SUPERIORITY_OR_OTHER|||||||0.6355||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6355
73841016|NCT00561821|147230192|SUPERIORITY_OR_OTHER|||||||0.7865||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.7865
73841017|NCT00561821|147230193|SUPERIORITY_OR_OTHER|||||||0.4033||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.4033
73841018|NCT00561821|147230193|SUPERIORITY_OR_OTHER|||||||0.4153||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.4153
73841019|NCT00561821|147230193|SUPERIORITY_OR_OTHER|||||||0.6271||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6271
73841020|NCT00561821|147230194|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841021|NCT00561821|147230194|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841022|NCT00561821|147230194|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
73841023|NCT00561821|147230195|SUPERIORITY_OR_OTHER|||||||0.0243||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0243
73841024|NCT00561821|147230195|SUPERIORITY_OR_OTHER|||||||0.0242||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0242
73841025|NCT00561821|147230195|SUPERIORITY_OR_OTHER|||||||0.0007||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0007
73841026|NCT00561821|147230196|SUPERIORITY_OR_OTHER|||||||0.0199||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0199
73841027|NCT00561821|147230196|SUPERIORITY_OR_OTHER|||||||0.0316||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0316
73841028|NCT00561821|147230196|SUPERIORITY_OR_OTHER|||||||0.0014||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0014
73841029|NCT03379870|147230202|SUPERIORITY|Analyzed Consonant Nucleus Consonant (CNC) Word scores obtained 12-months post-activation to evaluate differences between groups. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores \<20%).||||||0.768||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.768
73841030|NCT03379870|147230203|SUPERIORITY|Analyzed BKB-SIN scores obtained 12-months post-activation to evaluate differences between groups. Scores range from -6 to +21 and lower scores are better.||||||0.529||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.529
73841031|NCT03379870|147230204|SUPERIORITY|Analyzed SSQ scores obtained pre-operatively and at 12-months post-activation to evaluate benefit of cochlear implantation.||||||0.01||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.010
73841032|NCT03379870|147230205|SUPERIORITY|Analyzed receptive language scores pre-operatively and 12-months post activation to test for change over time and differences between groups.|||||>|0.069||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||>.069
73841033|NCT03379870|147230206|SUPERIORITY|Analyzed articulation scores pre-operative and 12-months post activation to test for change over time and differences between groups.||||||0.02||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|Main effect of test point (pre-operative vs post-activation)||||||.02
73841034|NCT03379870|147230207|SUPERIORITY|Analyzed expressive language scores pre-operatively and 12-months post activation to test for change over time and differences between groups.||||||0.007||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|Main effect of test point (pre-operative vs post activation)||||||.007
73841035|NCT00831389|147230234|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median change in PG concentration due to exercise for the OL and CL study phases do not differ.||||0.791
73841036|NCT00831389|147230235|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events immediately following exercise for the OL and CL study phases do not differ.||||0.5
73841037|NCT00831389|147230236|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of nocturnal hypoglycemic events following exercise for the OL and CL study phases do not differ.||||0.25
73841038|NCT00831389|147230237|SUPERIORITY_OR_OTHER|||||||0.0669||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median peak post-prandial PG for the OL and CL study phases do not differ.||||0.0669
73841039|NCT00831389|147230238|SUPERIORITY_OR_OTHER|||||||0.2256||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median nadir PG immediately following exercise for the OL and CL study phases do not differ.||||0.2256
73841040|NCT00831389|147230239|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median overnight nadir PG for the OL and CL arms do not differ.||||0.791
73841041|NCT00831389|147230240|SUPERIORITY_OR_OTHER|||||||0.2036||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is within euglycemic range for the OL and CL phases do not differ.||||0.2036
73841042|NCT00831389|147230241|SUPERIORITY_OR_OTHER|||||||0.6221||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is above euglycemic range for the OL and CL phases do not differ.||||0.6221
73841043|NCT00831389|147230242|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is below euglycemic range for the OL and CL phases do not differ.||||0.021
73841044|NCT00831389|147230243|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events over 48 hour in-patient period for the OL and CL phases do not differ.||||0.0176
73841045|NCT01592747|147230249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.659|TWO_SIDED|95.0|0.7|1.8|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. memantine full dose.||1.8|0.7|0.6590
73841046|NCT01592747|147230249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7839|TWO_SIDED|95.0|0.7|1.7|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. Memantine reduced dose||1.7|0.7|0.7839
73841047|NCT01592747|147230251|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.8136|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.8136
73841048|NCT01592747|147230251|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9244|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.9244
73841049|NCT01592747|147230252|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.7611|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.7611
73841050|NCT01592747|147230252|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.3176|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.3176
73841051|NCT01592747|147230253|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.902|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.9020
73841052|NCT01592747|147230253|SUPERIORITY_OR_OTHER||Least squares mean difference|0.4||||0.1279|TWO_SIDED|95.0|-0.1|1.0|||ANCOVA|||||1.0|-0.1|0.1279
73841053|NCT01592747|147230254|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4144|TWO_SIDED|95.0|-0.4|1.1|||ANCOVA|||||1.1|-0.4|0.4144
73841054|NCT01592747|147230254|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4212|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4212
73841055|NCT01592747|147230255|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.6238|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.6238
73841056|NCT01592747|147230255|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||0.5957|TWO_SIDED|95.0|-0.5|0.9|||ANCOVA|||||0.9|-0.5|0.5957
73841057|NCT01592747|147230256|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.864|TWO_SIDED|95.0|-0.6|0.7|||ANCOVA|||||0.7|-0.6|0.8640
73841058|NCT01592747|147230256|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4362|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|||||0.9|-0.4|0.4362
73841059|NCT01592747|147230257|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.7182|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|0.7182
73841060|NCT01592747|147230257|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.839|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|0.8390
73841061|NCT01592747|147230258|SUPERIORITY_OR_OTHER||Least squares mean difference|0.7||||0.0813|TWO_SIDED|95.0|-0.1|1.4|||ANCOVA|||||1.4|-0.1|0.0813
73841062|NCT01592747|147230258|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4365|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4365
73841063|NCT01592747|147230259|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4213|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4213
73841064|NCT01592747|147230259|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4267|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4267
73841065|NCT01592747|147230260|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.3713||95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.3713
73841066|NCT01592747|147230260|SUPERIORITY_OR_OTHER||Least squares mean difference|0.4||||0.2855|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.2855
73841067|NCT00124657|147230267|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.75|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.48|1.0||||||1-year progression-free survival (n=8)||1.00|0.48|
73841068|NCT00124657|147230267|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.33|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.09|0.57||||||1-year progression-free survival (n=12)||0.57|0.09|
73841069|NCT00124657|147230267|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.45|STANDARD_DEVIATION|0.106|||TWO_SIDED|95.0|0.198|0.602||||||1-year progression free survival (n=20)||0.602|0.198|
73841070|NCT00124657|147230267|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.15|STANDARD_DEVIATION|0.069|||TWO_SIDED|95.0|0.015|0.285||||||2-year progression free survival (n=20)||0.285|0.015|
73841071|NCT00124657|147230267|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.19|STANDARD_DEVIATION|0.077|||TWO_SIDED|95.0|0.039|0.341||||||1-year progression free survival (n=21)||0.341|0.039|
73841072|NCT00124657|147230267|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.19|STANDARD_DEVIATION|0.077|||TWO_SIDED|95.0|0.039|0.341||||||2-year progression free survival (n=21)||0.341|0.039|
73841073|NCT05273437|147230298|OTHER|We conducted a Bayesian Regression for all available participants, then visualized the results. (N x 16 table, N: number of participants).|Credibility interval|80.0|||||TWO_SIDED||||||Bayesian Regression|We explicitly sought 80% credibility of at least 100 steps more within the 3-hour increment in comparison to the intervention.|We decided that 100 steps/3 hours is the minimum value of the MAP intervention effect estimate and that an INUS condition is valid only if there is at least an 80% chance of achieving an effect beyond 100 steps/3 hours.|We hypothesized that some individuals have their own time and decision-policy-specific response pattern regardless of day elapsed since the beginning of the intervention. We did not hypothesize the direction of the effect variation.|The decision point was the unit of analysis. For the Bayesian Regression, we used Markov Chain Monte Carlo (MCMC). Four sampling chains were used when performing Bayesian modeling. The number of estimation samples and target acceptance rate were gradually increased until numerical stability was achieved. The number of estimation samples was increased by multiplied by 2, as advised by previous literature, depending on the ratio of convergence diagnostics R̂ \> 1.1. We used 100 steps increase during 3 hours as the effect threshold value. We assumed that there is an effect only if the estimated effect is more than 80% probable (i.e., the credibility interval is over 100 steps/3 hours) and the Maximum A Posteriori Point (MAP) of the effect is more than 100 steps/3 hours. Otherwise, there is no effect. Among the models with effects, we clipped to 1000 steps/3hours as a maximum if the MAP was greater than 1000 steps/3 hours.|||
73841074|NCT02655601|147230309|SUPERIORITY||Hazard Ratio (HR)|0.791||||0.135|ONE_SIDED|95.0||95.0||Study was originally designed with 1 IA after approximately 42 deaths. An unplanned, 2nd IA was conducted to support a BTDR. The study was not terminated early as a result of either IAs. No further IA were conducted until the primary analysis.|Log Rank|89 study participants had passed away at the time of this analysis (41 in the RT/TMZ + BMX-001 arm and 48 in the Radiation Therapy/TMZ arm).||A 1-tailed logrank test was conducted at the 0.2 level. This test had 90% power to detect a hazard ratio of 0.63 after 84 deaths were observed among the 160 randomized patients.||95||0.135
73841075|NCT02655601|147230321|SUPERIORITY||Odds Ratio (OR)|0.45||||0.465|ONE_SIDED||||||Fisher Exact|||With 78 and 71 patients in Arms A and B, respectively, there was 80% power with a one-tailed chi-square test (α=0.05) to detect a reduction in grade 3 or 4 thrombocytopenia from 15% in Arm B (without BMX-001) to 3.7% in Arm A (with BMX-001). Given the small number of patients that experienced low platelet counts or thrombocytopenia, a one-tailed Fisher's exact test was performed instead.||||0.465
73841076|NCT02655601|147230322|SUPERIORITY||Hazard Ratio (HR)|0.978||||0.911|ONE_SIDED||||||Log Rank|||A 1-tailed logrank test was conducted at the 0.2 level.||||0.911
73841077|NCT02655601|147230323|SUPERIORITY|||||||0.401|||||||Chi-squared, Corrected|A continuity adjusted Chi-Squared test was performed.||||||0.401
73841078|NCT02528305|147230336|SUPERIORITY_OR_OTHER|||||||0.474|||||||ANOVA|||||||0.474
73841079|NCT02528305|147230337|SUPERIORITY_OR_OTHER|||||||0.174|||||||ANOVA|||||||0.174
73841080|NCT02528305|147230338|SUPERIORITY_OR_OTHER|||||||0.303|||||||ANOVA|||||||0.303
73841081|NCT02528305|147230339|SUPERIORITY|||||||0.023|||||||ANOVA|||||||0.023
73841082|NCT02528305|147230340|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANOVA|For the analysis of Total body fat||||||0.092
73841083|NCT02528305|147230340|SUPERIORITY_OR_OTHER|||||||0.101|||||||ANOVA|For the analysis of Trunk fat||||||0.101
73841084|NCT02528305|147230341|SUPERIORITY_OR_OTHER|||||||0.771|||||||ANOVA|For the analysis of systolic blood pressure||||||0.771
73841085|NCT02528305|147230341|SUPERIORITY_OR_OTHER|||||||0.028|||||||ANOVA|For the analysis of diastolic blood pressure||||||0.028
73841086|NCT02528305|147230342|SUPERIORITY_OR_OTHER|||||||0.099|||||||ANOVA|For the analysis of Physical Function||||||0.099
73841087|NCT02528305|147230342|SUPERIORITY_OR_OTHER|||||||0.566|||||||ANOVA|For the analysis of Social Function||||||0.566
73841088|NCT02528305|147230342|SUPERIORITY_OR_OTHER|||||||0.246|||||||ANOVA|For the analysis of Mental Health||||||0.246
73841089|NCT02528305|147230342|SUPERIORITY_OR_OTHER|||||||0.145|||||||ANOVA|For the analysis of Pain||||||0.145
73841090|NCT02528305|147230342|SUPERIORITY_OR_OTHER|||||||0.085|||||||ANOVA|For the analysis of Change in Health||||||0.085
73841091|NCT02528305|147230342|SUPERIORITY_OR_OTHER|||||||0.114|||||||ANOVA|For the analysis of Physical Role Limitation||||||0.114
73841092|NCT02528305|147230342|SUPERIORITY_OR_OTHER|||||||0.841|||||||ANOVA|For the analysis of Mental Role Limitation||||||0.841
73841093|NCT02528305|147230342|SUPERIORITY_OR_OTHER|||||||0.366|||||||ANOVA|For the analysis of Energy/Vitality||||||0.366
73841094|NCT02528305|147230342|SUPERIORITY_OR_OTHER|||||||0.745|||||||ANOVA|For the analysis of Health Perception||||||0.745
73841095|NCT02528305|147230343|SUPERIORITY_OR_OTHER|||||||0.31|||||||ANOVA|||||||0.310
73841096|NCT02528305|147230344|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73841097|NCT02528305|147230345|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||||||0.005
73841098|NCT02528305|147230346|SUPERIORITY_OR_OTHER|||||||0.793|||||||ANOVA|||||||0.793
73841099|NCT02528305|147230347|SUPERIORITY_OR_OTHER|||||||0.513|||||||ANOVA|||||||0.513
73841100|NCT02528305|147230348|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANOVA|||||||0.009
73841101|NCT00787800|147230349|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Log Rank|||||||1.0
73841102|NCT00787800|147230351|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.050
73841103|NCT00787800|147230353|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73841104|NCT00373360|147230355|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
73841105|NCT00373360|147230356|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.008
73841106|NCT00373360|147230357|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
73841107|NCT00373360|147230358|SUPERIORITY_OR_OTHER|||||||0.531||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.531
73841108|NCT00373360|147230359|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
73841109|NCT00373360|147230360|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.500
73841110|NCT00373360|147230361|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
73841111|NCT00373360|147230362|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||1.000
73841112|NCT00373360|147230363|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0
73841113|NCT00373360|147230364|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
73841114|NCT00373360|147230365|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.031
73841115|NCT00373360|147230366|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.031
73841116|NCT00373360|147230367|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.004
73841117|NCT00373360|147230368|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.063
73841118|NCT00373360|147230369|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||Wilcoxon signed rank test|||Change Between Baseline and Week 8||||0.203
73841119|NCT00373360|147230373|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||0.250
73841120|NCT00373360|147230374|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.207
73841121|NCT00373360|147230375|SUPERIORITY_OR_OTHER|||||||0.297||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.297
73841122|NCT00373360|147230376|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.004
73841123|NCT00773461|147230393|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73841124|NCT00773461|147230393|SUPERIORITY_OR_OTHER||||||<|0.0001||||||ITT Population (Sensitivity)|Cochran-Mantel-Haenszel|||||||<0.0001
73841125|NCT00773461|147230394|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Comparison of ACR 50 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel|||||||<0.0001
73841126|NCT00773461|147230394|SUPERIORITY_OR_OTHER|||||||0.0345||||||Comparison of ACR 70 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel|||||||0.0345
73841127|NCT00773461|147230396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||<|0.0001|TWO_SIDED|95.0|-6.6|-2.8||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Swollen Joint Count||-2.8|-6.6|<0.0001
73841128|NCT00773461|147230396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.3|-6.1||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Tender Joint Count||-6.1|-11.3|<0.0001
73841129|NCT00773461|147230397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.0001|TWO_SIDED|95.0|-25.3|-12.9|||ANCOVA|||||-12.9|-25.3|<0.0001
73841130|NCT00773461|147230398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.0001|TWO_SIDED|95.0|-24.5|-14.0|||ANCOVA|||||-14.0|-24.5|<0.0001
73841131|NCT00773461|147230399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.0|||<|0.0001|TWO_SIDED|95.0|-25.2|-12.7|||ANCOVA|||||-12.7|-25.2|<0.0001
73841132|NCT00773461|147230400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7384|||<|0.0001|TWO_SIDED|95.0|-2.1464|-1.3303|||ANCOVA|||||-1.3303|-2.1464|<0.0001
73841133|NCT00773461|147230401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.2|||<|0.0001|TWO_SIDED|95.0|-44.7|-33.7|||ANCOVA|||||-33.7|-44.7|<.0001
73841134|NCT00773461|147230403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.0003|TWO_SIDED|95.0|1.8|5.9|||ANCOVA|||||5.9|1.8|0.0003
73841135|NCT00773461|147230404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-68.3||||0.0599|TWO_SIDED|95.0|-139.5|2.9|||ANCOVA|||||2.9|-139.5|0.0599
73898497|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|4.45|||TWO_SIDED|||||||||Week 48||||
73841136|NCT00773461|147230405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.956|||<|0.0001|TWO_SIDED|95.0|9.125|16.786|||ANCOVA|||||16.786|9.125|<0.0001
73841137|NCT00773461|147230406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.28|||ANCOVA|||||-0.28|-0.56|<0.0001
73841138|NCT00913835|147230410|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.054||||0.8049|TWO_SIDED|90.0|0.751|1.478|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.||||1.478|0.751|0.8049
73841139|NCT00913835|147230411|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.115||||0.6346|TWO_SIDED|90.0|0.768|1.618|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.||||1.618|0.768|0.6346
73841140|NCT00913835|147230412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619|TWO_SIDED||||||Fisher Exact|||||||0.6190
73841141|NCT00637156|147230423|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.113||||1|TWO_SIDED|95.0|0.022|0.201||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.201|0.022|1.000
73841142|NCT00637156|147230423|SUPERIORITY_OR_OTHER|||||||0.993||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of overall success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.||||0.993
73841143|NCT00637156|147230424|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.088||||1|TWO_SIDED|95.0|0.012|0.167||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the NDI success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.167|0.012|1.000
73841144|NCT00637156|147230424|SUPERIORITY_OR_OTHER|||||||0.99||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of NDI success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.990
73841145|NCT00637156|147230425|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.05||||1|TWO_SIDED|95.0|-0.014|0.119||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the neurological success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.119|-0.014|1.000
73841146|NCT00637156|147230425|SUPERIORITY_OR_OTHER|||||||0.931||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neurological success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.931
73841147|NCT00637156|147230426|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.021||||1|TWO_SIDED|95.0|-0.019|0.062||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the neck pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.062|-0.019|1.000
73841148|NCT00637156|147230426|SUPERIORITY_OR_OTHER|||||||0.852||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neck pain success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.852
73863176|NCT03320330|147272448|OTHER|Recommended Phase 2 dose of pepinemab (VX15/2503), administered to children with recurrent or refractory solid tumors (Part A), was determined by the rolling-6 design.|Recommended Phase 2 dose|20.0|||||TWO_SIDED||||||||Recommended Phase 2 dose of pepinemab (VX15/2503) is 20 mg/kg.|||||
73863177|NCT01885910|147272460|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.0001
73863178|NCT04692077|147272470|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Reported Grade 2 and Above AEs|99.7|51.8|
73898498|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|0.57|STANDARD_ERROR_OF_MEAN|0.522||0.276|TWO_SIDED|95.0|-0.456|1.596||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.596|-0.456|0.276
73898499|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|3.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73841149|NCT00637156|147230427|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.008||||0.997|TWO_SIDED|95.0|-0.073|0.056||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the arm pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.056|-0.073|0.997
73841150|NCT00637156|147230427|SUPERIORITY_OR_OTHER|||||||0.395||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of arm pain success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.395
73841151|NCT00637156|147230428|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.024||||1|TWO_SIDED|95.0|-0.042|0.088||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the SF-36 PCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.088|-0.042|1.000
73841152|NCT00637156|147230428|SUPERIORITY_OR_OTHER|||||||0.767||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of SF-36 PCS success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.767
73841153|NCT00637156|147230429|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.024||||0.945|TWO_SIDED|95.0|-0.12|0.067||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the SF-36 MCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.067|-0.120|0.945
73841154|NCT00637156|147230430|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.017||||0.997|TWO_SIDED|95.0|-0.072|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the FSU success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.040|-0.072|0.997
73841155|NCT00637156|147230430|SUPERIORITY_OR_OTHER|||||||0.271||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of FSU success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.271
73841156|NCT00637156|147230431|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.013||||1|TWO_SIDED|95.0|-0.013|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the gait success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.040|-0.013|1.000
73841157|NCT00637156|147230431|SUPERIORITY_OR_OTHER|||||||0.859||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of gait success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.859
73841158|NCT00637156|147230432|SUPERIORITY_OR_OTHER||Posterior Mean Difference|0.4||||0|TWO_SIDED|95.0|0.252|0.548||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the operative time in two treatment groups was assessed. The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||0.548|0.252|0.0
73841159|NCT00637156|147230433|SUPERIORITY_OR_OTHER||Posterior Mean Difference|11.5||||0.02|TWO_SIDED|95.0|0.56|22.44|||Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the blood loss in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||22.440|0.560|0.02
73841160|NCT00637156|147230434|SUPERIORITY_OR_OTHER||Posterior Mean Difference|-0.1||||0.892|TWO_SIDED|95.0|-0.258|0.058||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the hospital stay in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||0.058|-0.258|0.892
73841161|NCT01308788|147230442|SUPERIORITY_OR_OTHER|||||||0.4414||95.0|||||ANCOVA|||||||.4414
73841162|NCT01308788|147230443|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANCOVA|||||||.7820
73841163|NCT01308788|147230444|SUPERIORITY_OR_OTHER|||||||0.5496||95.0|||||ANCOVA|||||||.5496
73841164|NCT01308788|147230445|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||ANCOVA|||||||.2930
73841165|NCT01308788|147230446|SUPERIORITY_OR_OTHER|||||||0.5058||95.0|||||ANCOVA|||||||.5058
73841166|NCT01308788|147230447|SUPERIORITY_OR_OTHER|||||||0.6156||95.0|||||ANCOVA|||||||.6156
73841167|NCT01308788|147230448|SUPERIORITY_OR_OTHER|||||||0.5443||95.0|||||ANCOVA|||||||.5443
73841168|NCT01308788|147230449|SUPERIORITY_OR_OTHER|||||||0.7847||95.0|||||ANCOVA|||||||.7847
73841169|NCT01308788|147230450|SUPERIORITY_OR_OTHER|||||||0.1331||95.0|||||ANCOVA|||||||.1331
73841170|NCT01308788|147230451|SUPERIORITY_OR_OTHER|||||||0.5431||95.0|||||ANCOVA|||||||.5431
73841171|NCT01308788|147230452|SUPERIORITY_OR_OTHER|||||||0.0684||95.0|||||ANCOVA|||||||.0684
73841172|NCT01308788|147230453|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||.2500
73841173|NCT01308788|147230454|SUPERIORITY_OR_OTHER|||||||0.6896||95.0|||||ANCOVA|||||||.6896
73841174|NCT01308788|147230455|SUPERIORITY_OR_OTHER|||||||0.7965||95.0|||||ANCOVA|||||||.7965
73841175|NCT02414841|147230463|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.932|TWO_SIDED|95.0|0.67|1.39|||Log Rank|Weighted|Performed as sensitivity analysis|||1.39|0.67|0.932
73841176|NCT02414841|147230464|SUPERIORITY|||||||0.328|||||||Chi-squared|||||||0.328
73841177|NCT04632030|147230495|OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.69|3.6|||||Adjusted for age, education, and lifetime tobacco use|||3.6|.69|
73841178|NCT04632030|147230495|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|1.28|6.55|||||Adjusted for age, education, and lifetime tobacco use|||6.55|1.28|
73841179|NCT04632030|147230496|OTHER||Odds Ratio (OR)|2.88|||||TWO_SIDED|95.0|1.28|6.47|||||Adjusted for age, education, and lifetime tobacco use|||6.47|1.28|
73841180|NCT04632030|147230496|OTHER||Odds Ratio (OR)|2.87|||||TWO_SIDED|95.0|1.26|6.5|||||Adjusted for age, education, and lifetime tobacco use|||6.50|1.26|
73841181|NCT04632030|147230497|OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.59|3.86|||||Adjusted for age, education, and lifetime tobacco use|||3.86|.59|
73841182|NCT04632030|147230497|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.73|4.67|||||Adjusted for age, education, and lifetime tobacco use|||4.67|.73|
73841183|NCT04632030|147230498|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.53|2.99|||||Adjusted for age, education, and lifetime tobacco use|||2.99|.53|
73841184|NCT04632030|147230498|OTHER||Odds Ratio (OR)|2.19|||||TWO_SIDED|95.0|0.94|5.13|||||Adjusted for age, education, and lifetime tobacco use|||5.13|.94|
73841185|NCT00964678|147230499|SUPERIORITY|||||||0.028|TWO_SIDED|20.0||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.028
73841186|NCT00964678|147230500|SUPERIORITY|||||||0.028||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.028
73841187|NCT00964678|147230501|SUPERIORITY||||||>|0.05|TWO_SIDED|20.0||||The threshold for statistical significance was p=0.05.|ANOVA|||||||>0.05
73841188|NCT00964678|147230502|SUPERIORITY||||||>|0.05|TWO_SIDED|20.0|||||ANOVA|||||||>0.05
73841189|NCT05339659|147230519|OTHER|The point null hypothesis of the significance test was a difference in expected number of log ins of 0.|Mean Difference (Final Values)|3.55||||0.219|TWO_SIDED|95.0|-2.33|9.44|||Regression, Linear||mean difference=experimental-control|A priori power calculations estimated detectable differences with 80% power with type 1 error rate=0.05, assuming a two-sided unequal variance t-test (standard deviations of 2.0 and 7.0 in the control and experimental arms, respectively) and a total sample of n=50 equally split between arms. Given a final sample size of 19 (7 control, 12 experimental), we re-calculated the detectable mean difference with these sample sizes (maintaining all other original assumptions), which is 6.51 sessions.||9.44|-2.33|0.219
73841190|NCT05339659|147230521|OTHER|The null hypothesis for the significance test is 0 difference in average number of days of use between arms.|Mean Difference (Final Values)|-22.12||||0.153|TWO_SIDED|95.0|-53.44|9.19|||Regression, Linear||mean difference=experimental-control|||9.19|-53.44|0.153
73841191|NCT05339659|147230522|OTHER|The null hypothesis for the significance test is a relative difference=0.|Risk Difference (RD)|0.095||||0.727|TWO_SIDED|95.0|-0.352|0.558|||Barnard's exact test||risk difference=experimental-control|||0.558|-0.352|0.727
73841192|NCT05339659|147230523|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|0.5||||0.325|TWO_SIDED|95.0|-0.6|1.61|||Regression, Linear||mean difference=experimental-control|||1.61|-0.60|0.325
73841193|NCT05339659|147230524|OTHER|The null hypothesis of the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|0.22||||0.745|TWO_SIDED|95.0|-1.28|1.72|||Regression, Linear||mean difference=experimental-control|||1.72|-1.28|0.745
73841194|NCT05339659|147230525|OTHER|The null hypothesis of the significance test is a risk difference=0.|Risk Difference (RD)|0.58||||0.009|TWO_SIDED|95.0|0.16|0.85|||Barnard's exact test||risk difference=experimental-control|||0.85|0.16|0.009
73841195|NCT05339659|147230528|OTHER|The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.|Mean Difference (Final Values)|1.39||||0.469|TWO_SIDED|95.0|-2.66|5.44|||Regression, Linear|Adjusted for baseline cigarettes/day.|mean difference=experimental-control|||5.44|-2.66|0.469
73863179|NCT04692077|147272471|OTHER||Exact CI for Proportions|11.1|||||TWO_SIDED|95.0|0.3|48.3|||||||Exact 95% Confidence Interval for Proportion for Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedures|48.3|0.3|
73841196|NCT05339659|147230529|OTHER|The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.|Mean Difference (Final Values)|-0.66||||0.614|TWO_SIDED|95.0|-3.48|2.16|||Regression, Linear|Adjusted for baseline cigarettes/day.|mean difference=experimental-control|||2.16|-3.48|0.614
73841197|NCT05339659|147230530|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-0.14||||0.9|TWO_SIDED|95.0|-2.67|2.38|||Regression, Linear||mean difference=experimental-control|||2.38|-2.67|0.90
73841198|NCT05339659|147230531|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-0.55||||0.632|TWO_SIDED|95.0|-3.03|1.93|||Regression, Linear||mean difference=experimental-control|||1.93|-3.03|0.632
73841199|NCT05339659|147230532|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-1.31||||0.227|TWO_SIDED|95.0|-3.55|-0.94|||Regression, Linear||mean difference=experimental-control|||-0.94|-3.55|0.227
73841200|NCT05339659|147230533|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-1.22||||0.274|TWO_SIDED|95.0|-3.58|1.15|||Regression, Linear||mean difference=experimental-control|||1.15|-3.58|0.274
73841201|NCT05339659|147230537|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|0.04||||0.981|TWO_SIDED|95.0|-0.39|0.39|||Barnard's exact test||risk difference=experimental-control|||0.39|-0.39|0.981
73841202|NCT05339659|147230538|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.01||||0.845|TWO_SIDED|95.0|-0.49|0.43|||Barnard's exact test||risk difference=experimental-control|||0.43|-0.49|0.845
73841203|NCT05339659|147230539|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.05||||0.56|TWO_SIDED|95.0|-0.47|0.28|||Barnard's exact test||||risk difference=experimental-control|0.28|-0.47|0.560
73841204|NCT05339659|147230540|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|0.04||||0.981|TWO_SIDED|95.0|-0.39|0.39|||Barnard's exact test||risk difference=experimental-control|||0.39|-0.39|0.981
73841205|NCT05339659|147230541|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.13||||0.632|TWO_SIDED|95.0|-0.49|0.34|||Barnard's exact test||risk difference=experimental-control|||0.34|-0.49|0.632
73841206|NCT05339659|147230542|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.03|||>|0.999|TWO_SIDED|95.0|-0.48|0.45|||Barnard's exact test||risk difference=experimental-control|||0.45|-0.48|>0.999
73841207|NCT02657356|147230585|SUPERIORITY||LS Mean difference (Net)|-12.86|STANDARD_ERROR_OF_MEAN|7.012||0.0683|TWO_SIDED|95.0|-26.69|0.98|||Mixed Models Analysis|Covariates: screening 6MWT, day 1 hemoglobin, treatment grp, # of PAH medications, time, interactions btwn treatment \& time, and screening 6MWT \& time|Difference is bardoxolone methyl - placebo|||0.98|-26.69|0.0683
73841208|NCT02657356|147230586|SUPERIORITY||Hazard Ratio (HR)|1.984||||0.0004|TWO_SIDED|95.0|1.36|2.895|||Chi-squared||Estimated from Cox Regression adjusted by baseline PAH medication status (0-1 vs 2) as the covariate. Hazard ratio \>1 indicates a beneficial effect that favors bardoxolone methyl.|||2.895|1.360|0.0004
73841209|NCT03443401|147230601|SUPERIORITY||Mean Difference (Net)|80.0||||0.004|TWO_SIDED|||||level of significance at \<0.05|Spearman's rho|||||||0.004
73841210|NCT03443401|147230602|SUPERIORITY||Mean Difference (Net)|80.0||||0.027|TWO_SIDED|||||Level of significance \<0.05|Spearman's rho|||||||0.027
73841211|NCT02254460|147230616|SUPERIORITY_OR_OTHER||[Treatment difference]|1.74||||0.0944|TWO_SIDED|95.0|0.9|3.34|||ANOVA||Treatment difference from ANOVA of log transformed data. Back transformed data are presented. This therefore represents the iron absorption ratio of the Micronutrient Fortified Drink (Test) to the Non-Fortified Drink (Control).|||3.34|0.90|0.0944
73841212|NCT02943499|147230617|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||To examine between-group differences in pre- vs. post-treatment cue reactivity, the post-treatment PCC BOLD response for the smoking vs neutral contrast was subtracted from the baseline response. The groups were then compared directly on this measure using a t-test.||||0.92
73841213|NCT01356940|147230627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.586||||0.586|TWO_SIDED||||||Mixed Models Analysis||P values above 0.05 are considered statistically not significant in this study|||||0.586
73841214|NCT00557440|147230667|SUPERIORITY_OR_OTHER||LS Mean Difference|0.165|STANDARD_ERROR_OF_MEAN|0.0492||0.001|TWO_SIDED|95.0|0.066|0.263||Statistical significance (two-sided) at 5% level. p-values were not corrected for multiplicity.|ANCOVA|Treatment, period, sequence and center as fixed effects, period baseline FEV1 as a covariate, and patient nested within sequence as a random effect.||||0.263|0.066|0.001
73841215|NCT03524157|147230672|NON_INFERIORITY|it will be considered non-inferior if there are no differences greater than 20%.||||||0.273|||||||Kruskal-Wallis|||||||0.273
73841216|NCT03524157|147230673|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%||||||0.788|||||||Kruskal-Wallis|||||||0.788
73841217|NCT03524157|147230675|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
73841218|NCT03524157|147230676|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%||||||0.008|||||||Kruskal-Wallis|||||||0.008
73841219|NCT03524157|147230677|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
73841220|NCT03524157|147230679|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
73841221|NCT03524157|147230680|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
73841222|NCT03524157|147230681|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared|||||||>0.05
73841223|NCT04620668|147230713|SUPERIORITY||||||<|0.001|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||<0.001
73841224|NCT04620668|147230713|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|Assessing change within treatment group (follow-up to Mixed ANOVA).||||||<0.001
74022340|NCT01431287|147597099|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.095|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.044|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.146|0.044|0.0003
73841225|NCT04620668|147230713|SUPERIORITY|||||||0.044|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from baseline to week 2 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.044
73841226|NCT04620668|147230713|SUPERIORITY|||||||0.001|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from week 2 to week 4 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.001
73841227|NCT04620668|147230713|SUPERIORITY|||||||0.731|||||||Repeated Measures ANOVA|Assessing change within control group (follow-up to Mixed ANOVA).||||||0.731
73841228|NCT04620668|147230714|SUPERIORITY||||||<|0.001|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||<0.001
73841229|NCT04620668|147230714|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|Assessing change within treatment group (follow-up to Mixed ANOVA).||||||<0.001
73841230|NCT04620668|147230714|SUPERIORITY|||||||0.05|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from baseline to week 2 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.05
73841231|NCT04620668|147230714|SUPERIORITY|||||||0.024|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from week 2 to week 4 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.024
73841232|NCT04620668|147230714|SUPERIORITY|||||||0.674|||||||Repeated Measures ANOVA|Assessing change within control group (follow-up to Mixed ANOVA).||||||0.674
74022341|NCT01431287|147597099|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.07|0.172||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.172|0.070|<0.0001
73841233|NCT04620668|147230715|SUPERIORITY|||||||0.159|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||0.159
73841234|NCT04620668|147230716|SUPERIORITY|||||||0.326|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||0.326
73841235|NCT01251757|147230723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|||<|0.001|TWO_SIDED|95.0|0.011|0.034|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.034|0.011|<.001
73841236|NCT01251757|147230723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||<|0.001|TWO_SIDED|95.0|0.019|0.042|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.042|0.019|<.001
73841237|NCT01251757|147230724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.022|TWO_SIDED|95.0|0.002|0.029|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.029|0.002|0.022
73841238|NCT01251757|147230724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|||<|0.001|TWO_SIDED|95.0|0.023|0.05|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.050|0.023|<.001
73841239|NCT01251757|147230725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.002|TWO_SIDED|95.0|1.05|1.24||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.24|1.05|0.002
73863180|NCT04692077|147272472|OTHER||Exact CI for Proportions|66.7|||||TWO_SIDED|95.0|22.3|95.7|||||||Exact 95% confidence interval for proportion for Participants who received at least one injection and preferred injectable PrEP at end of step 2.|95.7|22.3|
73841240|NCT01251757|147230725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16|||<|0.001|TWO_SIDED|95.0|1.06|1.26||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.26|1.06|<0.001
73841241|NCT01251757|147230726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.014|TWO_SIDED|95.0|1.02|1.23||adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.23|1.02|0.014
73841242|NCT01251757|147230726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21|||<|0.001|TWO_SIDED|95.0|1.1|1.32||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.32|1.10|<0.001
73841243|NCT01251757|147230727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.041|TWO_SIDED|95.0|-1.0|0.0||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||0.0|-1.0|.041
73841244|NCT01251757|147230727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.5|0.5||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||.5|-.5|.93
73841245|NCT01251757|147230728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.404|TWO_SIDED|95.0|0.93|1.19||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||1.19|0.93|.404
73841246|NCT01251757|147230728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.54|TWO_SIDED|95.0|0.85|1.09||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||1.09|.85|.54
73841247|NCT01251757|147230729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.38|TWO_SIDED|95.0|-1.8|0.7||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL subgroups.||0.7|-1.8|.38
73863181|NCT04692077|147272476|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||The Exact 95% Confidence Interval for Proportion for Number of Participants with Grade 2 or above AEs during Injection Phase.|99.7|51.8|
74022342|NCT01431287|147597099|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.064|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.166|0.064|<0.0001
74022343|NCT01431287|147597099|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.026||0.8241|TWO_SIDED|95.0|-0.045|0.057||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.057|-0.045|0.8241
73863182|NCT04692077|147272477|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Completed All Scheduled Injections among those who received at least one Injection|99.7|51.8|
73863183|NCT03826342|147272481|SUPERIORITY|||||||0.2964|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.2964
73841248|NCT01251757|147230729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.019|TWO_SIDED|95.0|-2.7|-0.2||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|MeanLDL levels were sig lower for IVR+ participants than for UC participants. In subgroup analyses this difference was most pronounced in those individuals with baseline LDL levels above 100 mg/dL (adj diff=-3.6 mg/dL, 95%CI= (-5.9, -1.3), p=.002).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||-0.2|-2.7|.019
73841249|NCT01251757|147230730|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.59|TWO_SIDED|95.0|0.93|1.13||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||1.13|0.93|.59
73841250|NCT01251757|147230730|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.058|TWO_SIDED|95.0|1.0|1.22||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|Though higher for the IVR+ group, LDL control did not differ significantly between the IVR+ and UC arms. Among those with poor initial control, however, control was sig better for the IVR+ arm (OR = 1.21, 95%CI = (1.04, 1.42), p=.015).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||1.22|1.00|.058
73841251|NCT02796651|147230731|SUPERIORITY||LSMean difference|0.108|||<|0.001|TWO_SIDED|95.0|0.055|0.161|||Mixed Models Analysis|||||0.161|0.055|<0.001
73841252|NCT02796651|147230731|SUPERIORITY||LSMean difference|0.117|||<|0.001|TWO_SIDED|95.0|0.064|0.171|||Mixed Models Analysis|||||0.171|0.064|<0.001
73841253|NCT02796651|147230731|SUPERIORITY||LSMean difference|0.162|||<|0.001|TWO_SIDED|95.0|0.107|0.216|||Mixed Models Analysis|||||0.216|0.107|<0.001
73841254|NCT02796651|147230731|SUPERIORITY||LSMean difference|0.122|||<|0.001|TWO_SIDED|95.0|0.069|0.175|||Mixed Models Analysis|||||0.175|0.069|<0.001
73841255|NCT02796651|147230731|SUPERIORITY||LSMean difference|0.009||||0.556|TWO_SIDED|95.0|-0.021|0.039|||Mixed Models Analysis|||||0.039|-0.021|0.556
73841256|NCT02796651|147230731|SUPERIORITY||LSMean difference|0.053||||0.001|TWO_SIDED|95.0|0.021|0.085|||Mixed Models Analysis|||||0.085|0.021|0.001
73841257|NCT02796651|147230731|SUPERIORITY||LSMean difference|0.014||||0.365|TWO_SIDED|95.0|-0.016|0.044|||Mixed Models Analysis|||||0.044|-0.016|0.365
73841258|NCT02796651|147230731|SUPERIORITY||LSMean difference|0.044||||0.006|TWO_SIDED|95.0|0.013|0.076|||Mixed Models Analysis|||||0.076|0.013|0.006
73841259|NCT02796651|147230731|SUPERIORITY||LSMean difference|0.005||||0.756|TWO_SIDED|95.0|-0.026|0.036|||Mixed Models Analysis|||||0.036|-0.026|0.756
73841260|NCT02796651|147230731|SUPERIORITY||LSMean difference|-0.039||||0.014|TWO_SIDED|95.0|-0.071|-0.008|||Mixed Models Analysis|||||-0.008|-0.071|0.014
73841261|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.13|||<|0.001|TWO_SIDED|95.0|0.091|0.169|||Mixed Models Analysis|||||0.169|0.091|<0.001
73841262|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.167|||<|0.001|TWO_SIDED|95.0|0.128|0.206|||Mixed Models Analysis|||||0.206|0.128|<0.001
73841263|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.224|||<|0.001|TWO_SIDED|95.0|0.184|0.263|||Mixed Models Analysis|||||0.263|0.184|<0.001
73898500|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.516||0.935|TWO_SIDED|95.0|-0.973|1.058||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.058|-0.973|0.935
73841264|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.214|||<|0.001|TWO_SIDED|95.0|0.176|0.253|||Mixed Models Analysis|||||0.253|0.176|<0.001
73841265|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.265|||<|0.001|TWO_SIDED|95.0|0.226|0.304|||Mixed Models Analysis|||||0.304|0.226|<0.001
73841266|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.037||||0.004|TWO_SIDED|95.0|0.012|0.062|||Mixed Models Analysis|||||0.062|0.012|0.004
73841267|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.094|||<|0.001|TWO_SIDED|95.0|0.068|0.119|||Mixed Models Analysis|||||0.119|0.068|<0.001
73841268|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.084|||<|0.001|TWO_SIDED|95.0|0.059|0.11|||Mixed Models Analysis|||||0.110|0.059|<0.001
73841269|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.135|||<|0.001|TWO_SIDED|95.0|0.109|0.161|||Mixed Models Analysis|||||0.161|0.109|<0.001
73841270|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.057|||<|0.001|TWO_SIDED|95.0|0.031|0.082|||Mixed Models Analysis|||||0.082|0.031|<0.001
73841271|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.047|||<|0.001|TWO_SIDED|95.0|0.023|0.071|||Mixed Models Analysis|||||0.071|0.023|<0.001
73841272|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.098|||<|0.001|TWO_SIDED|95.0|0.073|0.123|||Mixed Models Analysis|||||0.123|0.073|<0.001
73841273|NCT02796651|147230732|SUPERIORITY||LSMean difference|-0.009||||0.469|TWO_SIDED|95.0|-0.035|0.016|||Mixed Models Analysis|||||0.016|-0.035|0.469
73841274|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.041||||0.002|TWO_SIDED|95.0|0.015|0.068|||Mixed Models Analysis|||||0.068|0.015|0.002
73841275|NCT02796651|147230732|SUPERIORITY||LSMean difference|0.051|||<|0.001|TWO_SIDED|95.0|0.025|0.076|||Mixed Models Analysis|||||0.076|0.025|<0.001
73841276|NCT02796651|147230733|SUPERIORITY||LSMean difference|0.159|||<|0.001|TWO_SIDED|95.0|0.105|0.213|||Mixed Models Analysis|||||0.213|0.105|<0.001
73841277|NCT02796651|147230733|SUPERIORITY||LSMean difference|0.17|||<|0.001|TWO_SIDED|95.0|0.116|0.224|||Mixed Models Analysis|||||0.224|0.116|<0.001
73841278|NCT02796651|147230733|SUPERIORITY||LSMean difference|0.219|||<|0.001|TWO_SIDED|95.0|0.163|0.274|||Mixed Models Analysis|||||0.274|0.163|<0.001
73841279|NCT02796651|147230733|SUPERIORITY||LSMean difference|0.179|||<|0.001|TWO_SIDED|95.0|0.125|0.233|||Mixed Models Analysis|||||0.233|0.125|<0.001
73841280|NCT02796651|147230733|SUPERIORITY||LSMean difference|0.011||||0.488|TWO_SIDED|95.0|-0.02|0.042|||Mixed Models Analysis|||||0.042|-0.020|0.488
73841281|NCT02796651|147230733|SUPERIORITY||LSMean difference|0.06|||<|0.001|TWO_SIDED|95.0|0.027|0.092|||Mixed Models Analysis|||||0.092|0.027|<0.001
73841282|NCT02796651|147230733|SUPERIORITY||LSMean difference|0.02||||0.206|TWO_SIDED|95.0|-0.011|0.051|||Mixed Models Analysis|||||0.051|-0.011|0.206
73841283|NCT02796651|147230733|SUPERIORITY||LSMean difference|0.049||||0.004|TWO_SIDED|95.0|0.016|0.081|||Mixed Models Analysis|||||0.081|0.016|0.004
73841284|NCT02796651|147230733|SUPERIORITY||LSMean difference|0.009||||0.567|TWO_SIDED|95.0|-0.022|0.041|||Mixed Models Analysis|||||0.041|-0.022|0.567
73841285|NCT02796651|147230733|SUPERIORITY||LSMean difference|-0.039||||0.017|TWO_SIDED|95.0|-0.072|-0.007|||Mixed Models Analysis|||||-0.007|-0.072|0.017
73841286|NCT02796651|147230734|SUPERIORITY||LSMean difference|0.075||||0.027|TWO_SIDED|95.0|0.008|0.141|||Mixed Models Analysis|||||0.141|0.008|0.027
73841287|NCT02796651|147230734|SUPERIORITY||LSMean difference|0.065||||0.054|TWO_SIDED|95.0|-0.001|0.131|||Mixed Models Analysis|||||0.131|-0.001|0.054
73841288|NCT02796651|147230734|SUPERIORITY||LSMean difference|0.1||||0.004|TWO_SIDED|95.0|0.032|0.168|||Mixed Models Analysis|||||0.168|0.032|0.004
73841289|NCT02796651|147230734|SUPERIORITY||LSMean difference|0.059||||0.075|TWO_SIDED|95.0|-0.006|0.123|||Mixed Models Analysis|||||0.123|-0.006|0.075
73841290|NCT02796651|147230734|SUPERIORITY||LSMean difference|-0.01||||0.615|TWO_SIDED|95.0|-0.048|0.028|||Mixed Models Analysis|||||0.028|-0.048|0.615
74022344|NCT01431287|147597100|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.158|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.108|0.208||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.208|0.108|<0.0001
74084245|NCT01525628|147721682|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|150.45|STANDARD_DEVIATION|55.1||0.821|TWO_SIDED|90.0|106.81|211.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||211.91|106.81|0.8210
73841291|NCT02796651|147230734|SUPERIORITY||LSMean difference|0.025||||0.209|TWO_SIDED|95.0|-0.014|0.065|||Mixed Models Analysis|||||0.065|-0.014|0.209
73841292|NCT02796651|147230734|SUPERIORITY||LSMean difference|-0.016||||0.403|TWO_SIDED|95.0|-0.053|0.022|||Mixed Models Analysis|||||0.022|-0.053|0.403
73841293|NCT02796651|147230734|SUPERIORITY||LSMean difference|0.035||||0.074|TWO_SIDED|95.0|-0.003|0.074|||Mixed Models Analysis|||||0.074|-0.003|0.074
73841294|NCT02796651|147230734|SUPERIORITY||LSMean difference|-0.006||||0.75|TWO_SIDED|95.0|-0.045|0.032|||Mixed Models Analysis|||||0.032|-0.045|0.750
73841295|NCT02796651|147230734|SUPERIORITY||LSMean difference|-0.041||||0.035|TWO_SIDED|95.0|-0.08|-0.003|||Mixed Models Analysis|||||-0.003|-0.080|0.035
73841296|NCT04910165|147230767|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
73841297|NCT04910165|147230768|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
73841298|NCT04910165|147230769|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
73841299|NCT04910165|147230770|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
73841300|NCT04910165|147230771|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
73841301|NCT04910165|147230772|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Fisher Exact|||||||<0.05
73841302|NCT04910165|147230773|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Fisher Exact|||||||<0.05
73841303|NCT01287208|147230774|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
73841304|NCT01287208|147230777|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
73841305|NCT04003389|147230797|SUPERIORITY||LSMean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.0604|TWO_SIDED|95.0|-0.36|0.21||LSM, SE, CI, \& p-values come from an analysis of covariance (ANCOVA) model with change from baseline at Week 52 timepoint as response, treatment \& smoking status (current vs former/never) as fixed effects with baseline weight \& baseline as covariate.|ANCOVA|||LSMeans (LSM), standard errors (SE), confidence intervals (CI)||0.21|-0.36|0.0604
73841306|NCT04003389|147230797|SUPERIORITY||LSMean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.45|0.11||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.11|-0.45|0.239
73841307|NCT04003389|147230799|SUPERIORITY||LSMean difference|0.007|STANDARD_ERROR_OF_MEAN|0.003||0.029|TWO_SIDED|95.0|0.001|0.014||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.014|0.001|0.029
73841308|NCT04003389|147230799|SUPERIORITY||LSMean difference|0.001|STANDARD_ERROR_OF_MEAN|0.003||0.867|TWO_SIDED|95.0|-0.006|0.007||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.007|-0.006|0.867
73841309|NCT04003389|147230799|SUPERIORITY||LSMean difference|0.006|STANDARD_ERROR_OF_MEAN|0.003||0.027|TWO_SIDED|95.0|0.001|0.012||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.012|0.001|0.027
73863184|NCT03826342|147272481|SUPERIORITY|||||||0.3404|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.3404
73841310|NCT04003389|147230799|SUPERIORITY||LSMean difference|0.002|STANDARD_ERROR_OF_MEAN|0.003||0.41|TWO_SIDED|95.0|-0.003|0.008||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.008|-0.003|0.410
73841311|NCT04003389|147230799|SUPERIORITY||LSMean difference|0.005|STANDARD_ERROR_OF_MEAN|0.003||0.087||95.0|-0.001|0.011||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.011|-0.001|0.087
73841312|NCT04003389|147230799|SUPERIORITY||LSMean difference|0.003|STANDARD_ERROR_OF_MEAN|0.003||0.259||95.0|-0.002|0.009||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.009|-0.002|0.259
73841313|NCT04003389|147230800|SUPERIORITY||LSMean difference|0.048|STANDARD_ERROR_OF_MEAN|0.027||0.079|TWO_SIDED|95.0|-0.006|0.102||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.102|-0.006|0.079
73841314|NCT04003389|147230800|SUPERIORITY||LSMean difference|0.001|STANDARD_ERROR_OF_MEAN|0.027||0.98|TWO_SIDED|95.0|-0.052|0.053||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.053|-0.052|0.980
73841315|NCT04003389|147230800|SUPERIORITY||LSMean difference|0.048|STANDARD_ERROR_OF_MEAN|0.023||0.042||95.0|0.002|0.094||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.094|0.002|0.042
73841316|NCT04003389|147230800|SUPERIORITY||LSMean difference|0.02|STANDARD_ERROR_OF_MEAN|0.023||0.386||95.0|-0.025|0.065||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.065|-0.025|0.386
73841317|NCT04003389|147230800|SUPERIORITY||LSMean difference|0.041|STANDARD_ERROR_OF_MEAN|0.029||0.156||95.0|-0.016|0.099||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.099|-0.016|0.156
73841318|NCT04003389|147230800|SUPERIORITY||LSMean difference|0.028|STANDARD_ERROR_OF_MEAN|0.029||0.328|TWO_SIDED|95.0|-0.028|0.084||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.084|-0.028|0.328
73841319|NCT04003389|147230801|SUPERIORITY||LSMean difference|0.002|STANDARD_ERROR_OF_MEAN|0.004||0.497||95.0|-0.005|0.009||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.009|-0.005|0.497
73841320|NCT04003389|147230801|SUPERIORITY||LSMean difference|-0.001|STANDARD_ERROR_OF_MEAN|0.004||0.878||95.0|-0.007|0.006||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.006|-0.007|0.878
73841321|NCT04003389|147230802|SUPERIORITY||LSMean difference|0.02|STANDARD_ERROR_OF_MEAN|0.031||0.527|TWO_SIDED|95.0|-0.042|0.082||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.082|-0.042|0.527
73841322|NCT04003389|147230802|SUPERIORITY||LSMean difference|-0.005|STANDARD_ERROR_OF_MEAN|0.031||0.872||95.0|-0.066|0.056||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.056|-0.066|0.872
73841323|NCT03926247|147230844|OTHER|Within-group longitudinal analysis (no comparison groups)|LSM Final Difference|-0.044|STANDARD_ERROR_OF_MEAN|0.019|=|0.019|TWO_SIDED|95.0|-0.087|-0.008|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' depression/anxiety symptoms would decrease overtime.||-0.008|-0.087|=0.019
73841324|NCT03926247|147230845|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.892|STANDARD_ERROR_OF_MEAN|0.643|=|0.168|TWO_SIDED|95.0|-2.161|0.372|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' PTSD symptoms would decrease overtime.||0.372|-2.161|=0.168
73841325|NCT03926247|147230846|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.035|=|0.051|TWO_SIDED|95.0|-0.14|0.0|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' stress would decrease overtime.||-0.000|-0.140|=0.051
73863185|NCT03826342|147272482|SUPERIORITY|||||||0.7915|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.7915
73841326|NCT03926247|147230847|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.029|=|0.211|TWO_SIDED|95.0|-0.106|0.023|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' social support would increase overtime.||0.023|-0.106|=0.211
73841327|NCT03926247|147230848|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.053|=|0.074|TWO_SIDED|95.0|-0.008|0.201|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' access to resources would increase overtime.||0.201|-0.008|=0.074
73841328|NCT03926247|147230849|OTHER|Within-group longitudinal analysis (no comparison groups)=|Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.061|=|0.089|TWO_SIDED|95.0|-0.257|0.017|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' difficulty accessing resources would decrease overtime.||0.017|-0.257|=0.089
73841329|NCT03926247|147230850|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.216|STANDARD_ERROR_OF_MEAN|0.124|=|0.086|TWO_SIDED|95.0|-0.461|0.03|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' quality of life would increase overtime.||0.030|-0.461|=0.086
73841330|NCT00322218|147230872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8578|||||||Stratified Log-Rank Test|||||||0.8578
73841331|NCT00488293|147230902|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
73841332|NCT00488293|147230903|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Chi-squared|||||||0.88
73841333|NCT00488293|147230904|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||t-test, 2 sided|||||||0.39
73841334|NCT00488293|147230905|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
73841335|NCT00488293|147230906|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
74022345|NCT01431287|147597100|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.072|STANDARD_ERROR_OF_MEAN|0.025||0.0048|TWO_SIDED|95.0|0.022|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.122|0.022|0.0048
73841336|NCT00488293|147230907|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||t-test, 2 sided|||||||0.61
73841337|NCT00488293|147230908|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
73841338|NCT00488293|147230909|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||t-test, 2 sided|||||||0.73
73841339|NCT00488293|147230910|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
73841340|NCT00488293|147230911|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Chi-squared|||||||0.65
73898501|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.35|||TWO_SIDED|95.0|||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73841341|NCT00500331|147230912|OTHER|Tukey's trend test for dose response: Change= Baseline+Treatment|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change= Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg, GSK189075 1000 mg||||<0.001
73841342|NCT00500331|147230912|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg||||<0.001
73841343|NCT00500331|147230912|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg||||<0.001
73841344|NCT00500331|147230912|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg||||<0.001
73841345|NCT00500331|147230912|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg||||<0.001
73841346|NCT00500331|147230912|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.02|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 50 mg||-0.44|-1.02|<0.001
73841347|NCT00500331|147230912|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.94|-0.35||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 100 mg||-0.35|-0.94|<0.001
73841348|NCT00500331|147230912|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|||<|0.001|TWO_SIDED|95.0|-1.03|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 250 mg||-0.44|-1.03|<0.001
73841349|NCT00500331|147230912|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.19|-0.61||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 500 mg||-0.61|-1.19|<0.001
73841350|NCT00500331|147230912|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||<|0.001|TWO_SIDED|95.0|-1.36|-0.77||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 1000 mg||-0.77|-1.36|<0.001
73841351|NCT00500331|147230912|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76|||<|0.001|TWO_SIDED|95.0|-1.05|-0.47||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. Pioglitazone 30 mg||-0.47|-1.05|<0.001
73841352|NCT03345550|147230935|SUPERIORITY|||||||0.24|||||||Kruskal-Wallis|||Baseline||||.24
73841353|NCT03345550|147230935|SUPERIORITY|||||||0.43|||||||Kruskal-Wallis|||1 month analysis||||.43
73841354|NCT03345550|147230935|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||3 month||||.54
73841355|NCT03345550|147230938|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||.31
73841356|NCT00137449|147230955|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|50.0||||||95.0|31.3|68.7|||F distribution|||||68.7|31.3|
73841357|NCT00137449|147230955|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|56.7||||||95.0|37.4|74.5|||F distribution|||||74.5|37.4|
73841358|NCT00137449|147230955|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|53.3||||||95.0|40.0|66.3|||F distribution|||Null hypothesis that the true CBR \<=20% vs the alternative hypothesis that the true clinical benefit rate is at least 35%. The sample size is determined using a single-stage design with an alpha level of 10% \& 90% power. If \>=17 CR, PR or SD for at least 24 weeks are observed, null hypothesis can be rejected with a 20% target false positive error rate. If \<= 16 CR, PR,or SD for at least 24 weeks are observed, null hypothesis can not be rejected with a target false negative error rate of 10%.||66.3|40.0|
73841359|NCT00137449|147230957|SUPERIORITY_OR_OTHER||ORR rate (percentage)|10.0||||||95.0|2.1|26.5|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||26.5|2.1|
73841360|NCT00137449|147230957|SUPERIORITY_OR_OTHER||ORR rate (percentage)|16.7||||||95.0|5.6|34.7|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||34.7|5.6|
73841361|NCT00137449|147230957|SUPERIORITY_OR_OTHER||ORR rate (percentage)|13.3||||||95.0|5.9|24.6|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||24.6|5.9|
73841362|NCT00137449|147230959|SUPERIORITY_OR_OTHER||median|27.0||||||95.0|22.0|73.1|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley. Median reported is progression free survival weeks.||73.1|22.0|
73841363|NCT00137449|147230959|SUPERIORITY_OR_OTHER||median|35.1||||||95.0|24.4|51.6|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.||51.6|24.4|
73841364|NCT00137449|147230959|SUPERIORITY_OR_OTHER||median|33.6||||||95.0|24.1|49.0|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.||49.0|24.1|
73959778|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|11.1||0.8598|ONE_SIDED|95.0|-30.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-30.7|0.8598
73841365|NCT00137449|147230960|SUPERIORITY_OR_OTHER||median|57.0||||||95.0|24.1|73.1|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||73.1|24.1|
73841366|NCT00137449|147230960|SUPERIORITY_OR_OTHER||median|42.1||||||95.0|26.1|65.9|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||65.9|26.1|
73841367|NCT00137449|147230960|SUPERIORITY_OR_OTHER||median|42.1||||||95.0|26.1|65.9|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||65.9|26.1|
73841368|NCT00137449|147230962|SUPERIORITY_OR_OTHER||1 year survival rate|60.0||||||95.0|40.5|75.0|||Kaplan-Meier method|||||75.0|40.5|
73841369|NCT00137449|147230962|SUPERIORITY_OR_OTHER||1 year survival rate|79.7||||||95.0|60.3|90.3|||Kaplan-Meier method|||||90.3|60.3|
73841370|NCT00137449|147230962|SUPERIORITY_OR_OTHER||1 year survival rate|69.7||||||95.0|56.3|79.7|||Kaplan-Meier method|||||79.7|56.3|
73841371|NCT02489279|147230966|SUPERIORITY|||||||0.026|||||||GLM with repeated measures ANOVA|||We used a General Linear Model (GLM) with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.||||0.026
73841372|NCT02489279|147230966|SUPERIORITY|||||||0.0075|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.0075
73841373|NCT02489279|147230966|SUPERIORITY|||||||0.25|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.25
73841374|NCT02489279|147230967|SUPERIORITY|||||||0.014|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.||||0.014
73841375|NCT02489279|147230967|SUPERIORITY|||||||0.0005|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.0005
73841376|NCT02489279|147230967|SUPERIORITY|||||||0.21|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.21
73841377|NCT02489279|147230968|SUPERIORITY|||||||1e-06|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.||||0.000001
73841378|NCT02489279|147230969|SUPERIORITY|||||||0.00018|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.||||0.00018
73841379|NCT00586157|147230972|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Z-test|||||||<.001
74022346|NCT01431287|147597100|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.101|0.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.200|0.101|<0.0001
74022347|NCT01431287|147597100|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.053|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.152|0.053|<0.0001
74022348|NCT01431287|147597100|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.025||0.0116|TWO_SIDED|95.0|0.014|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.014|0.0116
74022349|NCT01431287|147597100|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.025||0.7577|TWO_SIDED|95.0|-0.042|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom|spatial power covariance structure for within-patient errors|||0.058|-0.042|0.7577
74022350|NCT01431287|147597100|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.061|0.16||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.160|0.061|<0.0001
74022351|NCT01431287|147597100|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.086|STANDARD_ERROR_OF_MEAN|0.025||0.0007|TWO_SIDED|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.136|0.037|0.0007
74022352|NCT01431287|147597100|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.025||0.0621|TWO_SIDED|95.0|-0.002|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|-0.002|0.0621
74022353|NCT01431287|147597100|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.025||0.1266|TWO_SIDED|95.0|-0.011|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.089|-0.011|0.1266
74022354|NCT01431287|147597101|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.104|0.209||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.209|0.104|<0.0001
74022355|NCT01431287|147597101|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.087|STANDARD_ERROR_OF_MEAN|0.027||0.0013|TWO_SIDED|95.0|0.034|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.139|0.034|0.0013
73841380|NCT00586157|147230973|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Z-test|||||||.001
74022356|NCT01431287|147597101|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.118|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.223|0.118|<0.0001
74022357|NCT01431287|147597101|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.102|STANDARD_ERROR_OF_MEAN|0.027||0.0001|TWO_SIDED|95.0|0.049|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.154|0.049|0.0001
74022358|NCT01431287|147597101|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.027||0.0002|TWO_SIDED|95.0|0.048|0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.153|0.048|0.0002
73841381|NCT00586157|147230974|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Z-test|||||||.003
73841382|NCT00062764|147230979|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||paired t-test|||||||0.004
73841383|NCT02378480|147230980|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.7|||||TWO_SIDED|95.0|-6.3|4.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||4.9|-6.3|
73841384|NCT02378480|147230981|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-3.2|8.2|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.2|-3.2|
73841385|NCT02378480|147230982|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.8|||||TWO_SIDED|95.0|-1.0|6.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||6.9|-1.0|
73841386|NCT02014467|147230994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.42|||<|0.0001|TWO_SIDED|95.0|3.67|5.18|||ANCOVA|||||5.18|3.67|<0.0001
73841387|NCT02014467|147230994|SUPERIORITY_OR_OTHER|||||||0.7495||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.7495
73841388|NCT02014467|147230995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.21|||<|0.0001|TWO_SIDED|95.0|2.45|3.96|||ANCOVA|||||3.96|2.45|<0.0001
73841389|NCT02014467|147230995|SUPERIORITY_OR_OTHER|||||||0.9029||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.9029
73841390|NCT02014467|147230996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|||<|0.0001|TWO_SIDED|95.0|1.72|2.8|||ANCOVA|||||2.80|1.72|<0.0001
73841391|NCT02014467|147230996|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.1070
73841392|NCT02014467|147230997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.59|||<|0.0001|TWO_SIDED|95.0|0.98|2.2|||ANCOVA|||||2.20|0.98|<0.0001
73841393|NCT02014467|147230997|SUPERIORITY_OR_OTHER|||||||0.4369||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.4369
73841394|NCT02014467|147230998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.36|||<|0.0001||95.0|2.39|4.32|||ANCOVA|||||4.32|2.39|<0.0001
73959779|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|10.9||0.8005|ONE_SIDED|95.0|-27.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-27.4|0.8005
73841395|NCT02014467|147230998|SUPERIORITY_OR_OTHER|||||||0.6082||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.6082
73841396|NCT02014467|147230999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.31|||<|0.0001|TWO_SIDED|95.0|2.74|3.88|||ANCOVA|||||3.88|2.74|<0.0001
73841397|NCT02014467|147230999|SUPERIORITY_OR_OTHER|||||||0.3513||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.3513
73841398|NCT02014467|147231000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.62|||<|0.0001|TWO_SIDED|95.0|1.96|3.27|||ANCOVA|||||3.27|1.96|<0.0001
73841399|NCT02014467|147231000|SUPERIORITY_OR_OTHER|||||||0.541||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.5410
73841400|NCT02014467|147231001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.72|||<|0.0001|TWO_SIDED|95.0|3.71|5.72|||ANCOVA|||||5.72|3.71|<0.0001
73841401|NCT02014467|147231001|SUPERIORITY_OR_OTHER|||||||0.3957||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.3957
73841402|NCT02014467|147231002|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-56.92|||<|0.0001|TWO_SIDED|95.0|-61.38|-52.65||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 6|||-52.65|-61.38|<0.0001
73841403|NCT02014467|147231002|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-52.56|||<|0.0001||95.0|-59.38|-46.17||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 12|||-46.17|-59.38|<0.0001
73841404|NCT02014467|147231003|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-56.94|||<|0.0001|TWO_SIDED|95.0|-61.6|-52.7||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 6|||-52.70|-61.60|<0.0001
73841405|NCT02014467|147231003|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-51.21|||<|0.0001|TWO_SIDED|95.0|-56.26|-45.91||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 12|||-45.91|-56.26|<0.0001
73841406|NCT01217892|147231029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.084||0.0106|TWO_SIDED|95.0|-0.38|-0.05||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)||-0.05|-0.38|0.0106
73841407|NCT01217892|147231029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0843|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)||-0.18|-0.52|<0.0001
73863186|NCT03826342|147272482|SUPERIORITY|||||||0.2131|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.2131
73841408|NCT01217892|147231030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|0.363|<|0.0001|TWO_SIDED|95.0|-2.53|-1.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-1.10|-2.53|<0.0001
73841409|NCT01217892|147231030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|0.3636|<|0.0001|TWO_SIDED|95.0|-2.89|-1.46||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-1.46|-2.89|<0.0001
73841410|NCT01217892|147231031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|STANDARD_ERROR_OF_MEAN|3.04|<|0.0001|TWO_SIDED|95.0|-21.7|-9.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-9.7|-21.7|<0.0001
73841411|NCT01217892|147231031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|STANDARD_ERROR_OF_MEAN|3.039|<|0.0001|TWO_SIDED|95.0|-22.7|-10.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-10.7|-22.7|<0.0001
73841412|NCT01217892|147231032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.132||0.001|TWO_SIDED|95.0|-16.5|-4.2||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-4.2|-16.5|0.0010
73841413|NCT01217892|147231032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|3.139|<|0.0001|TWO_SIDED|95.0|-21.4|-9.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-9.1|-21.4|<0.0001
73841414|NCT01217892|147231033|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|6.097||0.0455|TWO_SIDED|95.0|0.2|24.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||24.1|0.2|0.0455
73841415|NCT01217892|147231033|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.8|STANDARD_ERROR_OF_MEAN|6.153||0.0062|TWO_SIDED|95.0|4.8|28.9||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||28.9|4.8|0.0062
73841416|NCT01052779|147231034|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.1||||0.515|TWO_SIDED|95.0|-0.21|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|With LOCF Imputation: The p-value and two-sided 95% confidence interval (CI) for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an analysis of variance (ANOVA) model adjusted for baseline hemoglobin level and hemodialysis status.||0.41|-0.21|0.515
73841417|NCT01052779|147231034|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.09||||0.587|TWO_SIDED|95.0|-0.23|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|Without Imputation (Sensitivity Analysis): The p-value and two-sided 95% CI for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an ANOVA model adjusted for baseline hemoglobin level and hemodialysis status.||0.41|-0.23|0.587
73841418|NCT03802916|147231038|SUPERIORITY|||||||0.0074||||||A p-value was calculated for the one-sample proportion test.|One-sample proportion test|||One-sample proportion test to determine if the overall preference for deferiprone DR was greater than chance (i.e., a 50% preference for each formulation)||||0.0074
73841419|NCT03802916|147231038|SUPERIORITY|||||||0.0002||||||A p-value was calculated for the one-sample proportion test.|One-sample proportion test|||One-sample proportion test to determine if the overall preference for deferiprone DR was greater than chance (i.e., a 50% preference for each formulation)||||0.0002
73841420|NCT02069847|147231068|SUPERIORITY|||||||0.992|||||||ANOVA|||||||0.992
73841421|NCT02069847|147231069|SUPERIORITY|||||||0.531|||||||t-test, 2 sided|||Total number of budesonide subjects with 50% or greater esophageal stricture (N=4) vs total number of control subjects with 50% or greater esophageal structure (N=15)||||0.531
73841422|NCT04507763|147231073|OTHER|||||||0.001|||||||Regression, Logistic|||Change from Baseline at Month 12: For Early Referral||||0.001
73841423|NCT04507763|147231074|OTHER|||||||0.001|||||||Regression, Logistic|||Change from Baseline at Month 12: For Early Referral||||0.001
73841424|NCT02853136|147231096|OTHER||Adjusted geometric Mean ratio [%]|3107.8|||||TWO_SIDED|90.0|2332.9|4140.1|||||The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2. Intra-individual geometric coefficient of variation \[%\] =42.7.|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||4140.10|2332.90|
73841425|NCT02853136|147231097|OTHER||Adjusted geometric Mean ratio [%]|659.0|||||TWO_SIDED|90.0|489.791|886.676|||||The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2. Intra-individual geometric coefficient of variation \[%\]=44.8.|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||886.676|489.791|
73841426|NCT02853136|147231098|OTHER||Adjusted geometric Mean ratio [%]|3103.41|||||TWO_SIDED|90.0|2330.5|4132.65|||||"The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2.~Intra-individual geometric coefficient of variation \[%\] =42.7."|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||4132.65|2330.50|
73841427|NCT00841815|147231099|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|96.43||||||90.0|91.4|101.74|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.74|91.40|
73841428|NCT00841815|147231100|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.94||||||90.0|95.6|106.58|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.58|95.60|
73841429|NCT00841815|147231101|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.11||||||90.0|95.08|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.40|95.08|
73841430|NCT04805593|147231102|SUPERIORITY|Superiority testing was conducted to confirm the proportion is higher than the targeted value of 50%.|||||<|0.0001|||||||Exact Test of Binomial Proportion|||||||<0.0001
73841431|NCT04805593|147231103|SUPERIORITY|Superiority testing was conducted to confirm the proportion is higher than the targeted value of 75%.|||||<|0.0001|||||||Exact Test of Binomial Proportion|||||||<0.0001
73959780|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|9.6||0.3441|ONE_SIDED|95.0|-12.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.2|0.3441
73959781|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|6.9||0.4436|ONE_SIDED|95.0|-10.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-10.5|0.4436
73841432|NCT03464461|147231115|OTHER|non-parametric||||||0.9844|||||||Kruskal-Wallis|||||||0.9844
73841433|NCT03464461|147231116|OTHER|non-parametric||||||0.158|||||||Kruskal-Wallis|||||||0.1580
73841434|NCT03464461|147231117|OTHER|non-parametric||||||0.873|||||||Kruskal-Wallis|||||||0.8730
73841435|NCT03464461|147231118|OTHER|non-parametric||||||0.074|||||||Kruskal-Wallis|||||||0.0740
73841436|NCT03464461|147231119|OTHER|non-parametric||||||0.0984|||||||Kruskal-Wallis|||||||0.0984
73841437|NCT03685149|147231123|SUPERIORITY||percent reduction|72.0|||<|0.0001|TWO_SIDED|95.0|56.0|82.0|||Mixed Models Analysis|||||82|56|<0.0001
73841438|NCT03685149|147231124|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
73841439|NCT03685149|147231125|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
73841440|NCT03685149|147231126|SUPERIORITY|||||||0.207|||||||Wilcoxon (Mann-Whitney)|||||||0.207
73841441|NCT00209131|147231147|NON_INFERIORITY_OR_EQUIVALENCE||||||<|0.05||95.0|||||Other|||No analysis was conducted.||||<0.05
73841442|NCT04918771|147231207|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.0003|TWO_SIDED|95.0|0.51|1.67|||t-test, 2 sided|||Mean time to resolution of ARVI symptoms||1.67|0.51|0.0003
73841443|NCT04918771|147231208|SUPERIORITY||Mean Difference (Final Values)|2.35||||0.3274|TWO_SIDED|95.0|-2.36|7.06|||t-test, 2 sided|||Mean AUC score for severity of ARVI (Clinically Diagnosed and/or PCR-confirmed).||7.06|-2.36|0.3274
73841444|NCT04918771|147231208|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.1171|TWO_SIDED|95.0|-1.34|11.93|||t-test, 2 sided|||Mean AUC score for severity of ARVI (PCR-confirmed).||11.93|-1.34|0.1171
73841445|NCT04918771|147231209|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73841446|NCT04918771|147231210|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.0073|TWO_SIDED|95.0|0.16|1.0|||t-test, 2 sided|||The mean time to Resolution of ARVI Symptoms was analysed.||1.00|0.16|0.0073
73841447|NCT04918771|147231211|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73841448|NCT04918771|147231212|SUPERIORITY|||||||0.3627|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 1.||||0.3627
73841449|NCT04918771|147231212|SUPERIORITY|||||||0.5578|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 2.||||0.5578
73841450|NCT04918771|147231212|SUPERIORITY|||||||0.7688|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 3.||||0.7688
73841451|NCT04918771|147231213|SUPERIORITY|||||||0.4926|||||||Fisher Exact|||||||0.4926
73841452|NCT04918771|147231214|SUPERIORITY|||||||0.021|||||||Fisher Exact|||Comparison of severity distributions.||||0.021
73841453|NCT04918771|147231214|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison for outcome distribution.||||1.00
73841454|NCT04918771|147231215|SUPERIORITY|||||||0.7848|||||||Median test|||Comparison for Visit 1.||||0.7848
73841455|NCT04918771|147231215|SUPERIORITY|||||||0.9596|||||||Median test|||Comparison for Visit 2.||||0.9596
73841456|NCT04918771|147231215|SUPERIORITY|||||||0.6902|||||||Median test|||Comparison for Visit 3.||||0.6902
73841457|NCT04918771|147231216|SUPERIORITY|||||||0.3266|||||||Median test|||Comparison for Visit 1.||||0.3266
73841458|NCT04918771|147231216|SUPERIORITY|||||||0.093|||||||Median test|||Comparison for Visit 2.||||0.0930
73841459|NCT04918771|147231216|SUPERIORITY|||||||0.2308|||||||Median test|||Comparison for Visit 3.||||0.2308
73841460|NCT04918771|147231217|SUPERIORITY|||||||0.661|||||||Median test|||Comparison for Visit 1/Systolic blood pressure.||||0.6610
73841461|NCT04918771|147231217|SUPERIORITY|||||||0.4884|||||||Median test|||Comparison for Visit 2/Systolic blood pressure.||||0.4884
73841462|NCT04918771|147231217|SUPERIORITY|||||||0.3494|||||||Median test|||Comparison for Visit 3/Systolic blood pressure.||||0.3494
73841463|NCT04918771|147231217|SUPERIORITY|||||||0.9531|||||||Median test|||Comparison for Visit 1/Diastolic blood pressure.||||0.9531
73841464|NCT04918771|147231217|SUPERIORITY|||||||0.5506|||||||Median test|||Comparison for Visit 2/Diastolic blood pressure.||||0.5506
73841465|NCT04918771|147231217|SUPERIORITY|||||||0.8259|||||||Median test|||Comparison for Visit 3/Diastolic blood pressure.||||0.8259
73841466|NCT04918771|147231218|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
73841467|NCT01469156|147231223|OTHER|Visually significant ocular or systemic AEs were predominantly mild or moderate. No significant safety signals were observed in either group.High- and standard-dose ranibizumab were generally well tolerated without evidence of ocular or systemic severe adverse events, including arterial thromboembolic events.|data survey|28.0||||0.05|TWO_SIDED|95.0|0.0|28.0||28 ocular and non-ocular adverse events collected, in mild to moderate nature|t-test, 2 sided|||Purpose was to determine safety and efficacy of intravitreal high-dose ranibizumab in the treatment of active PCV.|Visually significant ocular or systemic AEs that were either reported by subjects or identified by imaging and/or ocular exam|28|0|0.05
73841468|NCT01299961|147231236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4|STANDARD_DEVIATION|13.1|<|0.01|TWO_SIDED||||||t-test, 2 sided|||Most involved side: Synovitis (S), tenosynovitis (T), and power Doppler (PD) of wrist (dorsal (D), palmar (P), and ulnar (U)); S and T of MCP 2,3 (P, plus D for T); PD of the MCP joints (P and D); S and PD of PIP 2, 3 (P, plus D for PD); S and PD for MTP 2, 4 (D). S and PD graded from 0 to 3, and max individual scores are 27 and 39, respectively. T graded on 0-1 scale; max T score is 5. High score is worse. The 7-joint US score is sum of T, S, and PD scores. Change calculated baseline- month 12.||||<0.01
73841469|NCT01299961|147231237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|3.7|<|0.01|TWO_SIDED||||||t-test, 2 sided|||7 joints were scanned by power doppler ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. PDUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total PDUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline PDUS minus 12 month PDUS.||||<0.01
73841470|NCT01299961|147231238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|3.7||0.19|TWO_SIDED||||||t-test, 2 sided|||7 joints were scanned by grey-scale ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. GSUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total GSUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline GSUS minus 12 month GSUS.||||0.19
73841471|NCT02904096|147231239|NON_INFERIORITY|Estimates for PA, PB, and PA-PB were reported together with one-sided 95% confidence interval (CI) for PA-PB constructed via the Farrington-Manning likelihood method. Here PA and PB are the percentage of subjects in Group A and B (Non-inferiority margin = 12%).|Difference in percentage|1.5|||||ONE_SIDED|95.0||3.35||||||||3.35||
73841472|NCT02904096|147231240|OTHER||Difference in Percentage|1.5|||||ONE_SIDED|95.0||3.35||||||||3.35||
73841473|NCT02904096|147231241|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Left Hand)-baseline and Group A: Flexion (Left Hand)-change from baseline at Month 24.||||<.001
73841474|NCT02904096|147231241|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Right Hand)-baseline and Group A: Flexion (Right Hand)-change from baseline at Month 24.||||<.001
73841475|NCT02904096|147231241|OTHER|||||||0.054|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Left Hand)-baseline and Group B: Flexion (Left Hand)-change from baseline at Month 24.||||.054
73841476|NCT02904096|147231241|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Right Hand)-baseline and Group B: Flexion (Right Hand)-change from baseline at Month 24.||||<.001
73841477|NCT02904096|147231241|OTHER|||||||0.049|||||||t-test, 1 sided|||Comparison between Group A: Extension (Left Hand)-baseline and Group A: Extension (Left Hand)-change from baseline at Month 24.||||.049
73841478|NCT02904096|147231241|OTHER|||||||0.003|||||||t-test, 1 sided|||Comparison between Group A: Extension (Right Hand)-baseline and Group A: Extension (Right Hand)-change from baseline at Month 24.||||.003
73841479|NCT02904096|147231241|OTHER|||||||0.781|||||||t-test, 1 sided|||Comparison between Group B: Extension (Left Hand)-baseline and Group B: Extension (Left Hand)-change from baseline at Month 24.||||.781
73841480|NCT02904096|147231241|OTHER|||||||0.573|||||||t-test, 1 sided|||Comparison between Group B: Extension (Right Hand)-baseline and Group B: Extension (Right Hand)-change from baseline at Month 24.||||.573
73841481|NCT02904096|147231242|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.||||<.001
73841482|NCT02904096|147231242|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.||||<.001
73841483|NCT02904096|147231242|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.||||<.001
73841484|NCT02904096|147231242|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.||||<.001
73841485|NCT02904096|147231243|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.||||<.001
73841486|NCT02904096|147231243|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.||||<.001
73841487|NCT02904096|147231243|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.||||<.001
73959782|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|6.8||0.7238|ONE_SIDED|95.0|-15.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.5|0.7238
74084246|NCT01525628|147721683|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|349.9|STANDARD_DEVIATION|46.4||1|TWO_SIDED|90.0|269.12|454.93|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||454.93|269.12|1.0000
73959783|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|6.0||0.5743|ONE_SIDED|95.0|-11.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.1|0.5743
73841488|NCT02904096|147231243|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.||||<.001
73841489|NCT02904096|147231244|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Left Hand)-baseline and Group A: Hand grip strength (Left Hand)-change from baseline at Month 24.||||<.001
73841490|NCT02904096|147231244|OTHER|||||||0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Right Hand)-baseline and Group A: Hand grip strength (Right Hand)-change from baseline at Month 24.||||.001
73841491|NCT02904096|147231244|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Left Hand)-baseline and Group B: Hand grip strength (Left Hand)-change from baseline at Month 24.||||<.001
73841492|NCT02904096|147231244|OTHER|||||||0.002|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Right Hand)-baseline and Group B: Hand grip strength (Right Hand)-change from baseline at Month 24.||||.002
73841493|NCT02904096|147231244|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Left Hand)-baseline and Group A: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
73841494|NCT02904096|147231244|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Right Hand)-baseline and Group A: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
73841495|NCT02904096|147231244|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Left Hand)-baseline and Group B: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
73841496|NCT02904096|147231244|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Right Hand)-baseline and Group B: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
73841497|NCT02904096|147231244|OTHER|||||||0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Left Hand)-baseline and Group A: Hand key pinch strength (Left Hand)-change from baseline at Month 24.||||.001
73841498|NCT02904096|147231244|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Right Hand)-baseline and Group A: Hand key pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
73841499|NCT02904096|147231244|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Left Hand)-baseline and Group B: Hand key pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
73841500|NCT02904096|147231244|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Right Hand)-baseline and Group B: Hand key pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
73841501|NCT02904096|147231244|OTHER|||||||0.01|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Left Hand)-baseline and Group A: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.||||.010
73841502|NCT02904096|147231244|OTHER|||||||0.06|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Right Hand)-baseline and Group A: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.||||.060
73841503|NCT02904096|147231244|OTHER|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Left Hand)-baseline and Group B: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.||||.177
73841504|NCT02904096|147231244|OTHER|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Right Hand)-baseline and Group B: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.||||.177
73841505|NCT05472870|147231282|SUPERIORITY|One-way ANOVA with repeated measures was used to examine differences in the effects of cTMS on the SRS. A P value \<0.05 was considered statistically significant for all analyses.|||||<|0.001||||||Bonferroni correction was used to adjust P values in post hoc analyses.|ANOVA|||All clinical behavioral data analysis was performed using Statistical Product and Service Solutions (SPSS) software (version 25.0). A P value \<0.05 was considered statistically significant for all analyses. One-way ANOVA with repeated measures was used to examine differences in the effects of cTMS on the SRS.||||<0.001
73841506|NCT04101331|147231343|OTHER|||||||0.051||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.051
73841507|NCT04101331|147231344|OTHER|||||||0.051||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.051
73841508|NCT04101331|147231345|OTHER|||||||0.112||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.112
73841509|NCT04101331|147231347|OTHER|||||||0.537||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.537
73841510|NCT04378153|147231387|SUPERIORITY||Difference in % Participants|2.17||||0.1215|TWO_SIDED|95.0|-0.7|5.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.7|-0.7|0.1215
73841511|NCT00666263|147231413|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squared means|35.13||||0.005|TWO_SIDED|95.0|8.81|61.46|||ANOVA|Fixed effects ANOVA with factors for sequence (1 or 2), nested within sequence, period (Cross-Over Period 1 or 2), \& treatment (IGIV, 10% or placebo)||||61.46|8.81|0.005
73841512|NCT00666263|147231414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
73841513|NCT00666263|147231416|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squared means|32.54|||<|0.001|TWO_SIDED|95.0|14.01|51.06|||ANOVA|||||51.06|14.01|<0.001
73841514|NCT00666263|147231417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
73841515|NCT00666263|147231421|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|6.03||||0.002|TWO_SIDED|95.0|2.14|9.92|||ANOVA|||||9.92|2.14|0.002
74084247|NCT01525628|147721683|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|176.56|STANDARD_DEVIATION|50.1||0.9533|TWO_SIDED|90.0|125.95|247.5|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||247.50|125.95|0.9533
73841516|NCT00666263|147231423|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-15.57|||<|0.001|TWO_SIDED|95.0|-24.37|-6.77|||ANOVA|||||-6.77|-24.37|<0.001
73841517|NCT00666263|147231425|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-26.11|||<|0.001|TWO_SIDED|95.0|-38.96|-13.26|||ANOVA|||||-13.26|-38.96|<0.001
73841518|NCT00666263|147231427|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-216.6||||0.059|TWO_SIDED|95.0|-490.41|57.22|||ANOVA|||||57.22|-490.41|0.059
73841519|NCT00666263|147231429|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
73841520|NCT00666263|147231430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021||95.0|||||McNemar|||||||0.021
73841521|NCT04023045|147231483|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
73841522|NCT04023045|147231484|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
73841523|NCT04023045|147231485|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
73841524|NCT04023045|147231486|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
73841525|NCT04023045|147231487|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
73841526|NCT04023045|147231488|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
73841527|NCT04023045|147231489|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
73841528|NCT04023045|147231490|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
73841529|NCT02743221|147231517|OTHER|This was a non-comparative study.|Hazard Ratio (HR)|0.71||||0.09|TWO_SIDED|95.0|0.48|1.06|||Cox proportional hazard model|Cox proportional hazard model with adjustment for the stratification factors (RAS status, performance status ECOG)||||1.06|0.48|0.09
73841530|NCT02743221|147231518|OTHER|||||||0.73|||||||Fisher Exact|||||||0.73
73841531|NCT02743221|147231519|OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.49|2.74||||||||2.74|0.49|
73841532|NCT02743221|147231520|OTHER|||||||0.22|||||||Fisher Exact|||||||0.22
73841533|NCT02743221|147231521|OTHER||Hazard Ratio (HR)|0.56||||0.04|TWO_SIDED|95.0|0.32|0.98|||Cox proportional hazard model|||||0.98|0.32|0.04
73841534|NCT00967499|147231585|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|||||||0.4010
73841535|NCT00967499|147231586|SUPERIORITY|||||||0.5672|||||||Cochran-Mantel-Haenszel|||||||0.5672
73841536|NCT00967499|147231587|SUPERIORITY|||||||0.057|||||||Cochran-Mantel-Haenszel|||||||0.0570
73841537|NCT00967499|147231588|SUPERIORITY|||||||0.515|||||||Cochran-Mantel-Haenszel|||||||0.5150
73841538|NCT00967499|147231589|SUPERIORITY|||||||0.3601||||||P-values are based on Cochran-Mantel-Haenszel row mean score test with gender adjustment for the ranks of the change from baseline values.|Cochran-Mantel-Haenszel|||||||0.3601
73841539|NCT00967499|147231590|SUPERIORITY|||||||0.3453|||||||Mann-Whitney Test|||24 hours postdose||||0.3453
73841540|NCT00967499|147231590|SUPERIORITY|||||||0.7874|||||||Mann-Whitney Test|||48 hours postdose||||0.7874
73841541|NCT00967499|147231590|SUPERIORITY|||||||0.8485|||||||Mann-Whitney Test|||72 Hours Postdose||||0.8485
73863187|NCT03826342|147272483|SUPERIORITY|||||||0.8357|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.8357
74022359|NCT01431287|147597101|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.027||0.6093|TWO_SIDED|95.0|-0.066|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.039|-0.066|0.6093
74084248|NCT01525628|147721684|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|322.68|STANDARD_DEVIATION|40.4||1|TWO_SIDED|90.0|256.24|406.34|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||406.34|256.24|1.0000
73841542|NCT05535972|147231604|OTHER||Least Square Mean|-6.81|STANDARD_ERROR_OF_MEAN|0.241|||TWO_SIDED|95.0|-7.28|-6.33|||||CFB in CAT score was analyzed using Mixed Model Repeated Measures(MMRM) model with covariates of smoking status, CAT score at Baseline, visit, interaction of CAT score at Baseline\*visit. Estimates derived from inverse probability weighted MMRM model.|||-6.33|-7.28|
73841543|NCT00835354|147231630|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|89.2||||||90.0|86.2|92.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.2|86.2|
73841544|NCT00835354|147231631|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.5||||||90.0|88.9|92.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.1|88.9|
73841545|NCT00835354|147231632|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.7||||||90.0|89.1|92.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.3|89.1|
73841546|NCT01385995|147231638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.57|TWO_SIDED|95.0|0.52|3.24|||Generalized Estimating Equation|Controlled for period and baseline 2 hour OGTT glucose level.||Based on an intent to treat approach a Generalized Estimating Equation (GEE) was used to estimate the effect of therapy (CPAP or Sham) on the odds of normalization of Impaired Glucose Tolerance (IGT). This model provides an estimate of the odds ratio of normalizing the 2-hour oral glucose tolerance test (OGTT) with CPAP compared with Sham-CPAP.||3.24|0.52|0.57
73841547|NCT01385995|147231639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.38|TWO_SIDED|95.0|-1.2|3.0|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP.||3.0|-1.2|0.38
73841548|NCT01385995|147231639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.11|TWO_SIDED|95.0|-16.3|1.7|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between measures of glucose indices, in this case, 2 hour OGTT, and therapeutic CPAP vs. Sham.||1.7|-16.3|0.11
73841549|NCT01385995|147231639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.86|TWO_SIDED|95.0|-3.3|2.7|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=25.||2.7|-3.3|0.86
73841550|NCT01385995|147231639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6||||0.08|TWO_SIDED|95.0|-24.6|1.3|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case 2-hour oral glucose tolerance test (OGTT) glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N= 25.||1.3|-24.6|0.08
73841551|NCT01385995|147231640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.14|TWO_SIDED|95.0|-3.4|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, fasting insulin, between CPAP and sham-CPAP.||0.5|-3.4|0.14
73841552|NCT01385995|147231640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7||||0.12|TWO_SIDED|95.0|-23.3|2.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, 2-hour oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP.||2.8|-23.3|0.12
73898502|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.523||0.942|TWO_SIDED|95.0|-0.99|1.066||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.066|-0.990|0.942
74022360|NCT01431287|147597101|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.027||0.0011|TWO_SIDED|95.0|0.035|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.140|0.035|0.0011
74022361|NCT01431287|147597101|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.027||0.0095|TWO_SIDED|95.0|0.017|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.123|0.017|0.0095
74022362|NCT01431287|147597101|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.027||0.0108|TWO_SIDED|95.0|0.016|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.121|0.016|0.0108
74022363|NCT01431287|147597101|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.027||0.9627|TWO_SIDED|95.0|-0.051|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|-0.051|0.9627
74022364|NCT01431287|147597102|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.162|0.074|<0.0001
74022365|NCT01431287|147597102|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.169|0.077|<0.0001
74022366|NCT01431287|147597102|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.022||0.0012|TWO_SIDED|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.114|0.028|0.0012
74084249|NCT01525628|147721684|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|145.93|STANDARD_DEVIATION|66.2||0.7461|TWO_SIDED|90.0|97.83|217.69|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||217.69|97.83|0.7461
74084250|NCT01525628|147721685|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|355.04|STANDARD_DEVIATION|29.9||1|TWO_SIDED|90.0|298.13|422.83|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||422.83|298.13|1.0000
74022367|NCT01431287|147597102|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.137|0.050|<0.0001
74022368|NCT01431287|147597102|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.023||0.001|TWO_SIDED|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.121|0.031|0.0010
74022369|NCT01431287|147597102|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.023||0.0384|TWO_SIDED|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.092|0.003|0.0384
74022370|NCT01431287|147597102|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.185|0.097|<0.0001
74022371|NCT01431287|147597102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.004|STANDARD_ERROR_OF_MEAN|0.023||0.8428|TWO_SIDED|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.040|-0.049|0.8428
74022372|NCT01431287|147597102|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.022||0.3048|TWO_SIDED|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.020|-0.065|0.3048
74022373|NCT01431287|147597102|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.023||0.4311|TWO_SIDED|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.063|-0.027|0.4311
74022374|NCT01431287|147597103|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.139|0.057|<0.0001
74022375|NCT01431287|147597103|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.149|0.063|<0.0001
74022376|NCT01431287|147597103|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.021||0.0136|TWO_SIDED|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.091|0.010|0.0136
74022377|NCT01431287|147597103|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.021||0.0003|TWO_SIDED|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.116|0.035|0.0003
74022378|NCT01431287|147597103|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.0065|TWO_SIDED|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.101|0.016|0.0065
74022379|NCT01431287|147597103|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0277|TWO_SIDED|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.089|0.005|0.0277
73841553|NCT01385995|147231640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1|TWO_SIDED|95.0|-5.2|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case fasting insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||0.5|-5.2|0.10
73841554|NCT01385995|147231640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.7||||0.002|TWO_SIDED|95.0|-46.5|-10.9|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||-10.9|-46.5|0.002
73841555|NCT01385995|147231641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.18|TWO_SIDED|95.0|-17.6|3.8|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP.||3.8|-17.6|0.18
73841556|NCT01385995|147231641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.1||||0.08|TWO_SIDED|95.0|-27.5|1.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin resistance, in this case Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||1.8|-27.5|0.08
73841557|NCT01385995|147231642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.2|TWO_SIDED|95.0|-2.0|9.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensivity Index, between CPAP and sham-CPAP.||9.8|-2.0|0.20
73841558|NCT01385995|147231642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.3||||0.002|TWO_SIDED|95.0|5.2|22.1|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensitivity Index (ISI(0,120)), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||22.1|5.2|0.002
73841559|NCT04191135|147231733|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4556|TWO_SIDED|95.0|0.72|1.33||One-sided p-value based on log-rank test stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|Log Rank||Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.33|0.72|0.4556
73841560|NCT04191135|147231734|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3903|TWO_SIDED|95.0|0.64|1.4||One-sided p-value based on log-rank test stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|Log Rank||Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.40|0.64|0.3903
73841561|NCT04191135|147231735|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.59|1.43|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and BRCA status (BRCAm versus BRCAwt).|||1.43|0.59|
73841562|NCT04191135|147231736|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.53|1.76|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and BRCA status (BRCAm versus BRCAwt).|||1.76|0.53|
73841563|NCT04191135|147231737|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.33|1.48|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and tumor PD-L1 status (CPS≥1 vs CPS\<1).|||1.48|0.33|
73841564|NCT04191135|147231738|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.28|2.37|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and tumor PD-L1 status (CPS≥1 vs CPS\<1).|||2.37|0.28|
73959784|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|9.8||0.619|ONE_SIDED|95.0|-19.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.3|0.6190
73959785|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|9.7||0.9473|ONE_SIDED|95.0|-32.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-32.1|0.9473
73841565|NCT04191135|147231739|SUPERIORITY||Difference in Least Squares Means|-3.28||||0.143|TWO_SIDED|95.0|-7.69|1.12|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||1.12|-7.69|0.1430
73841566|NCT04191135|147231740|SUPERIORITY||Difference in Least Squares Means|-0.16||||0.9454|TWO_SIDED|95.0|-4.89|4.56|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||4.56|-4.89|0.9454
74022380|NCT01431287|147597103|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.164|0.081|<0.0001
73841567|NCT04191135|147231741|SUPERIORITY||Difference in Least Squares Means|2.08||||0.4351|TWO_SIDED|95.0|-3.16|7.31|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||7.31|-3.16|0.4351
73841568|NCT04191135|147231742|SUPERIORITY||Difference in Least Squares Means|0.93||||0.5588|TWO_SIDED|95.0|-2.2|4.06|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||4.06|-2.20|0.5588
73841569|NCT04191135|147231743|SUPERIORITY||Difference in Least Squares Means|-0.37||||0.8408|TWO_SIDED|95.0|-4.03|3.28|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||3.28|-4.03|0.8408
73841570|NCT04191135|147231744|SUPERIORITY||Difference in Least Squares Means|-1.34||||0.795|TWO_SIDED|95.0|-11.63|8.95|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||8.95|-11.63|0.7950
73841571|NCT04191135|147231745|SUPERIORITY||Difference in Least Squares Means|4.82||||0.1597|TWO_SIDED|95.0|-1.97|11.62|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||11.62|-1.97|0.1597
73841572|NCT04191135|147231746|SUPERIORITY||Difference in Least Squares Means|2.52||||0.6138|TWO_SIDED|95.0|-7.45|12.49|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||12.49|-7.45|0.6138
73841573|NCT04191135|147231747|SUPERIORITY||Difference in Least Squares Means|-1.6||||0.5567|TWO_SIDED|95.0|-7.02|3.83|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||3.83|-7.02|0.5567
73841574|NCT04191135|147231748|SUPERIORITY||Difference in Least Squares Means|5.56||||0.105|TWO_SIDED|95.0|-1.2|12.32|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||12.32|-1.20|0.1050
73841575|NCT04191135|147231749|SUPERIORITY||Hazard Ratio (HR)|1.78||||0.00676|TWO_SIDED|95.0|1.16|2.71|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||2.71|1.16|0.00676
73841576|NCT04191135|147231750|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96425|TWO_SIDED|95.0|0.61|1.69|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.69|0.61|0.96425
73841577|NCT04191135|147231751|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.74965|TWO_SIDED|95.0|0.69|1.71|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.71|0.69|0.74965
73841578|NCT04191135|147231752|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.10502|TWO_SIDED|95.0|0.88|3.53|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||3.53|0.88|0.10502
73841579|NCT04191135|147231753|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.5019|TWO_SIDED|95.0|0.57|3.0|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||3.00|0.57|0.50190
73841580|NCT04191135|147231754|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.47384|TWO_SIDED|95.0|0.24|1.97|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||1.97|0.24|0.47384
73841581|NCT04191135|147231755|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.81463|TWO_SIDED|95.0|0.33|2.38|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||2.38|0.33|0.81463
73841582|NCT04191135|147231756|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.67255|TWO_SIDED|95.0|0.24|8.82|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||8.82|0.24|0.67255
74022381|NCT01431287|147597103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.7116|TWO_SIDED|95.0|-0.049|0.034||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.034|-0.049|0.7116
73841583|NCT03514134|147231761|SUPERIORITY||||||<|0.001|||||||ANCOVA|Repeated measures ANCOVA||||||<0.001
73841584|NCT03514134|147231762|SUPERIORITY|||||||0.358|||||||ANCOVA|Repeated measures ANCOVA||||||0.358
73841585|NCT03514134|147231763|SUPERIORITY|||||||0.029|||||||ANCOVA|Repeated measures ANCOVA||||||0.029
73841586|NCT03514134|147231764|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
73841587|NCT03514134|147231764|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
73841588|NCT03514134|147231765|SUPERIORITY|||||||0.7||||||Group by time interaction|ANOVA|Repeated measures ANOVA||||||0.70
73841589|NCT02471144|147231766|SUPERIORITY||Odds Ratio (OR)|25.78|||<|0.0001|TWO_SIDED|95.0|7.08|114.66|||Regression, Logistic|||vs Placebo||114.66|7.08|<.0001
73841590|NCT02471144|147231766|SUPERIORITY||Odds Ratio (OR)|22.65|||<|0.0001|TWO_SIDED|95.0|6.31|98.93|||Regression, Logistic|||vs Placebo||98.93|6.31|<.0001
74022382|NCT01431287|147597103|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.02||0.2332|TWO_SIDED|95.0|-0.065|0.016||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.016|-0.065|0.2332
73841591|NCT02471144|147231767|SUPERIORITY||Odds Ratio (OR)|51.77|||<|0.0001|TWO_SIDED|95.0|10.02|538.64|||Regression, Logistic|||vs Placebo||538.64|10.02|<.0001
73841592|NCT02471144|147231767|SUPERIORITY||Odds Ratio (OR)|32.52|||<|0.0001||95.0|6.48|329.52|||Regression, Logistic|||vs Placebo||329.52|6.48|<.0001
73841593|NCT02471144|147231768|SUPERIORITY||Odds Ratio (OR)|72.5|||<|0.0001|TWO_SIDED|95.0|55.9|84.9|||Regression, Logistic|||vs Placebo||84.9|55.9|<.0001
73841594|NCT02471144|147231768|SUPERIORITY||Odds Ratio (OR)|67.5|||<|0.0001|TWO_SIDED|95.0|50.8|80.9|||Regression, Logistic|||vs Placebo||80.9|50.8|<.0001
73841595|NCT00107575|147231786|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||||||>.05
73841596|NCT00107575|147231787|SUPERIORITY_OR_OTHER||expected count ratio|0.81||||0.027|TWO_SIDED|95.0|0.67|0.98||a priori p-value was p \< .05|generalized estimating equations|Negative binomial model controlling for sex, motivation to change drinking, and baseline drinking||||0.98|0.67|.027
73841597|NCT00107575|147231788|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Chi-squared|||||||.18
73841598|NCT00107575|147231789|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Chi-squared|||||||.95
73841599|NCT00107575|147231790|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Chi-squared|||||||.76
73841600|NCT03977155|147231794|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.35||0.3776|TWO_SIDED|95.0|-1.0|0.38|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.38|-1.00|0.3776
73841601|NCT03977155|147231794|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-0.73|0.82||||||Statistical Analysis 2||0.82|-0.73|
73841602|NCT03977155|147231794|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_ERROR_OF_MEAN|0.403|||TWO_SIDED|95.0|-1.41|0.19||||||Statistical Analysis 3||0.19|-1.41|
73841603|NCT03977155|147231794|SUPERIORITY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|95.0|-0.13|1.44||||||Statistical Analysis 4||1.44|-0.13|
73841604|NCT03977155|147231796|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.211||0.884|TWO_SIDED|95.0|-0.45|0.39|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.39|-0.45|0.8840
73841605|NCT03977155|147231796|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.249|||TWO_SIDED|95.0|-0.6|0.39||||||Statistical Analysis 2||0.39|-0.60|
73841606|NCT03977155|147231796|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.43|0.49||||||Statistical Analysis 3||0.49|-0.43|
73841607|NCT03977155|147231796|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|95.0|-0.63|0.36||||||Statistical Analysis 4||0.36|-0.63|
73841608|NCT03977155|147231797|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.228||0.4725|TWO_SIDED|95.0|-0.62|0.29|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.29|-0.62|0.4725
73841609|NCT03977155|147231797|SUPERIORITY||Median Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|95.0|-0.71|0.31||||||Statistical Analysis 2||0.31|-0.71|
73841610|NCT03977155|147231797|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|-0.62|0.37||||||Statistical Analysis 3||0.37|-0.62|
73841611|NCT03977155|147231797|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|95.0|-0.6|0.45||||||Statistical Analysis 4||0.45|-0.60|
73841612|NCT03977155|147231798|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5693|TWO_SIDED|95.0|-0.28|0.51|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.51|-0.28|0.5693
73841613|NCT03977155|147231798|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|-0.35|0.63||||||Statistical Analysis 2||0.63|-0.35|
73841614|NCT03977155|147231798|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.33|0.51||||||Statistical Analysis 3||0.51|-0.33|
73841615|NCT03977155|147231798|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.41|0.51||||||Statistical Analysis 4||0.51|-0.41|
73841616|NCT03977155|147231799|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-7.71|STANDARD_ERROR_OF_MEAN|25.208||0.7603|TWO_SIDED|95.0|-57.76|42.33|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||42.33|-57.76|0.7603
73841617|NCT03977155|147231799|SUPERIORITY||Mean Difference (Net)|24.0|STANDARD_ERROR_OF_MEAN|29.087|||TWO_SIDED|95.0|-34.22|82.22||||||Statistical Analysis 2||82.22|-34.22|
73841618|NCT03977155|147231799|SUPERIORITY||Mean Difference (Net)|-33.42|STANDARD_ERROR_OF_MEAN|27.285|||TWO_SIDED|95.0|-87.91|21.07||||||Statistical Analysis 3||21.07|-87.91|
73841619|NCT03977155|147231799|SUPERIORITY||Mean Difference (Net)|57.42|STANDARD_ERROR_OF_MEAN|28.174|||TWO_SIDED|95.0|1.16|113.69||||||Statistical Analysis 4||113.69|1.16|
73841620|NCT03977155|147231800|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.137||0.2149|TWO_SIDED|95.0|-0.44|0.1|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.10|-0.44|0.2149
73841621|NCT03977155|147231800|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.27|0.29||||||Statistical Analysis 2||0.29|-0.27|
73841622|NCT03977155|147231800|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.64|-0.01||||||Statistical Analysis 3||-0.01|-0.64|
73841623|NCT03977155|147231800|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.02|0.65||||||Statistical Analysis 4||0.65|0.02|
73841624|NCT00775658|147231805|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Before the study, we determined that a sample size of 18 would be adequate to detect a 20% difference in wheal and flare areas with 80% power and a significance level of 0.05.||||0.57
73841625|NCT00775658|147231806|SUPERIORITY|Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
73841626|NCT05796245|147231857|OTHER|Estimation|Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.39|5.2|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||5.20|0.39|
73841627|NCT05796245|147231857|OTHER|Estimation|Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.38|5.34|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||5.34|0.38|
73841628|NCT05796245|147231857|OTHER|Estimation|Risk Difference (RD)|0.04|||||TWO_SIDED|95.0|-0.2|0.11|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.11|-0.20|
73841629|NCT05796245|147231857|OTHER|Estimation|Cox Proportional Hazard|1.63|||||TWO_SIDED|95.0|0.54|4.9|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||4.90|0.54|
73841630|NCT05796245|147231857|OTHER|Estimation|Risk Ratio (RR)|1.71|||||TWO_SIDED|95.0|0.55|5.26|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||5.26|0.55|
73841631|NCT05796245|147231857|OTHER|Estimation|Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.1|0.39|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.39|-0.10|
73841632|NCT05796245|147231857|OTHER|Estimation|Cox Proportional Hazard|2.44|||||TWO_SIDED|95.0|1.05|5.67|||||Crude Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||5.67|1.05|
73841633|NCT05796245|147231857|OTHER|Estimation|Risk Ratio (RR)|2.47|||||TWO_SIDED|95.0|1.02|5.99|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||5.99|1.02|
73841634|NCT05796245|147231857|OTHER|Estimation|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.06|0.32|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.32|-0.06|
73898503|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.35|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898504|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.569||0.578|TWO_SIDED|95.0|-0.802|1.436||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.436|-0.802|0.578
73898505|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73841635|NCT05796245|147231858|OTHER|Estimation|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.01|0.0|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the Comparative analysis set (IPTW weighted) and for the Comparative matched analysis set could not be calculated. Also, crude hazard ratio and crude risk ratio could not be calculated.||0.00|-0.01|
73841636|NCT05796245|147231859|OTHER|Estimation|Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.12|12.49|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||12.49|0.12|
73841637|NCT05796245|147231859|OTHER|Estimation|Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.12|17.14|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||17.14|0.12|
73841638|NCT05796245|147231859|OTHER|Estimation|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.05|0.01|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.01|-0.05|
73841639|NCT05796245|147231859|OTHER|Estimation|Cox Proportional Hazard|6.12|||||TWO_SIDED|95.0|0.81|45.94|||||Crude Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the comparative matched analysis set could not be calculated.||45.94|0.81|
73841640|NCT05796245|147231859|OTHER|Estimation|Risk Ratio (RR)|7.07|||||TWO_SIDED|95.0|0.93|53.51|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||53.51|0.93|
73841641|NCT05796245|147231859|OTHER|Estimation|Risk Difference (RD)|0.03|||||TWO_SIDED|95.0|-0.04|0.1|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.10|-0.04|
73841642|NCT05796245|147231860|OTHER|Estimation|Cox Proportional Hazard|1.7|||||TWO_SIDED|95.0|0.16|17.61|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||17.61|0.16|
73841643|NCT05796245|147231860|OTHER|Estimation|Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|0.17|19.79|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||19.79|0.17|
73841644|NCT05796245|147231860|OTHER|Estimation|Risk Difference (RD)|0.01|||||TWO_SIDED|95.0|-0.12|0.03|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.03|-0.12|
73841645|NCT05796245|147231860|OTHER|Estimation|Cox Proportional Hazard|2.61|||||TWO_SIDED|95.0|0.15|45.68|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||45.68|0.15|
73841646|NCT05796245|147231860|OTHER|Estimation|Risk Ratio (RR)|2.01|||||TWO_SIDED|95.0|0.12|34.94|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||34.94|0.12|
73841647|NCT05796245|147231860|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.1|0.26|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.26|-0.10|
73841648|NCT05796245|147231860|OTHER|Estimation|Cox Proportional Hazard|2.7|||||TWO_SIDED|95.0|0.37|19.93|||||Crude Hazard Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||19.93|0.37|
73841649|NCT05796245|147231860|OTHER|Estimation|Risk Ratio (RR)|2.66|||||TWO_SIDED|95.0|0.37|19.31|||||Crude Risk Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||19.31|0.37|
73841650|NCT05796245|147231860|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.05|0.1|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.10|-0.05|
73841651|NCT05796245|147231861|OTHER|Estimation|Cox Proportional Hazard|0.18|||||TWO_SIDED|95.0|0.02|1.85|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||1.85|0.02|
73841652|NCT05796245|147231861|OTHER|Estimation|Risk Ratio (RR)|0.19|||||TWO_SIDED|95.0|0.02|1.99|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||1.99|0.02|
73841653|NCT05796245|147231861|OTHER|Estimation|Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.17|0.0|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.00|-0.17|
73841654|NCT05796245|147231861|OTHER|Estimation|Cox Proportional Hazard|0.63|||||TWO_SIDED|95.0|0.07|6.0|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||6.00|0.07|
73841655|NCT05796245|147231861|OTHER|Estimation|Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.08|6.61|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||6.61|0.08|
73841656|NCT05796245|147231861|OTHER|Estimation|Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.1|0.21|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.21|-0.10|
73841657|NCT05796245|147231861|OTHER|Estimation|Cox Proportional Hazard|2.07|||||TWO_SIDED|95.0|0.28|15.22|||||Crude Hazard Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||15.22|0.28|
73841658|NCT05796245|147231861|OTHER|Estimation|Risk Ratio (RR)|2.1|||||TWO_SIDED|95.0|0.29|15.08|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||15.08|0.29|
73841659|NCT05796245|147231861|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.05|0.09|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.09|-0.05|
73959786|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|8.5||0.8014|ONE_SIDED|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.4|0.8014
73841660|NCT04999267|147231862|OTHER|Pre-intervention vs. Post-intervention analysis|||||<|0.0001|||||||Chi-squared|||||||<0.0001
73841661|NCT04999267|147231863|OTHER|Pre-intervention vs. Post-intervention analysis|||||<|0.0001|||||||Chi-squared|||||||<.0001
73841662|NCT03809000|147231875|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1396|TWO_SIDED|80.0|0.56|0.94|||Log Rank|One-sided significance level = 0.10|Reference level = standard ADT|After protocol amendments, the 3-year PFS rate of the standard arm was expected to be 24%. Assuming a hazard ratio of 0.65 (treatment/control) results in a hypothesized 3-year PFS rate of 39.5% on the enhanced ADT arm. A one-sided log-rank test with alpha=0.10 at 80% statistical power was calculated to require 101 events from 170 patients, taking into account expected accrual rate and follow-up time.||0.94|0.56|0.1396
73841663|NCT03360344|147231886|OTHER|non-parametric tests were used as data was not normally distributed.||||||0.48|||||||Wilcoxan signed Rank|||statistical analysis for wrist||||0.48
73841664|NCT03360344|147231886|OTHER|nonparametric test were used as the distribution was not normal.||||||0.99|||||||Wilcoxan Signed Rank|||statistical analysis for forearm||||.99
73959787|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|8.6||0.7929|ONE_SIDED|95.0|-21.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.5|0.7929
74022383|NCT01431287|147597103|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.021||0.4374|TWO_SIDED|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.059|-0.025|0.4374
73841665|NCT03360344|147231887|OTHER|||||||0.001|||||||ANOVA|||statistical analysis for forearm||||.001
73841666|NCT03360344|147231887|OTHER|||||||0.001|||||||ANOVA|||statistical analysis for wrist||||.001
73841667|NCT03360344|147231888|OTHER|||||||0.06|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.06
73841668|NCT03360344|147231889|OTHER|||||||0.01|||||||ANCOVA|||||||.01
73841669|NCT03360344|147231890|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||.001
73841670|NCT03257657|147231898|OTHER|||||||0.1|||||||t-test, 2 sided|||||||0.1
73841671|NCT03257657|147231900|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
73841672|NCT03257657|147231902|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
73841673|NCT01905540|147231916|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.244|||||TWO_SIDED|90.0|1.081|1.43||||||||1.430|1.081|
73863188|NCT03826342|147272483|SUPERIORITY|||||||0.095|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.0950
73863189|NCT03826342|147272484|SUPERIORITY|||||||0.7496|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.7496
73841674|NCT01905540|147231917|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Geometric LS Means|1.233|||||TWO_SIDED|90.0|1.07|1.422||||||||1.422|1.070|
73841675|NCT01905540|147231918|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.344|||||TWO_SIDED|90.0|1.135|1.592||||||||1.592|1.135|
73841676|NCT02743962|147231965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_DEVIATION|2.12|||TWO_SIDED|||||||||The control group reported a mean reduction in O'Leary-Sant Insterstitial Cystitis Symptom Score from baseline to 6 weeks that met the MCID (4 points), whereas the TW group reported a reduction of 1.5 times the MCID (ISCI score change: control group 4.25, + 0.95, TW group 6.2, + 0.83). From 6 to 12 weeks the control group reported no change in ISCI score (0 + 0.95) whereas the Therapeutic Wand group ISCI socre reduced by 1.8 +1.73.||||
73841677|NCT02743962|147231965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.25|STANDARD_DEVIATION|2.67|||TWO_SIDED|||||||||There was a small mean baseline ICPI score difference of 1.2 points between the groups (control group 10.5, +, TW group 11.2, + 2.68). Both groups reported a reduction in their ICPI scores from baseline to twelve weeks; the control group nearly met the minimal clinically important difference of 4 points and the TW group reported nearly twice the control group's score change (mean change control group 3.75, + 2.44, TW group 7, + 1.87).||||
73841678|NCT04330859|147232017|SUPERIORITY||Agresti-Caffo|95.0||||0.0543|TWO_SIDED|||||58.8 ± 7.2 (intervention) and 57.2 ± 11.2 (control; p = 0.0543)|t-test, 1 sided|||||||0.0543
73841679|NCT06045273|147232036|SUPERIORITY||Slope|0.224|STANDARD_ERROR_OF_MEAN|0.064||0.0006|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.0006
73841680|NCT06045273|147232037|SUPERIORITY||Slope|0.084|STANDARD_ERROR_OF_MEAN|0.043||0.0504|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.0504
73841681|NCT06045273|147232038|SUPERIORITY||Slope|0.131|STANDARD_ERROR_OF_MEAN|0.04||0.00134|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.00134
73841682|NCT00427700|147232039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.0||||0.3|TWO_SIDED|95.0|-9.0|33.0|||Fisher Exact|||The null hypothesis is that there is no significant difference between two drugs for ovulation induction.A sample size of 40 women per arm was calculated for this superiority trial, considering an alpha and beta error of 0.05 and 0.2, respectively, to find an absolute difference of 30% in the ovulation rate between groups, based on a previous study published by Mitwally and Casper (18) where the ovulation rate with CC was approximately 45%.||33|-9|0.3
73841683|NCT00427700|147232040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0||||0.2|TWO_SIDED|95.0|-6.0|34.0|||t-test, 2 sided|||Null hypothesis: There is no difference between the mean values of progesterone between both groups.||34|-6|0.2
73841684|NCT02014376|147232041|SUPERIORITY||||||=|0.3699|||||||Fisher Exact|||||||=0.3699
73841685|NCT02951481|147232047|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
73959788|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|8.4||0.9963|ONE_SIDED|95.0|-37.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-37.3|0.9963
73841686|NCT02951481|147232048|SUPERIORITY|||||||0.55|TWO_SIDED|95.0|||||Fisher Exact|||||||0.55
73841687|NCT02951481|147232049|SUPERIORITY|||||||0.023|||||||Chi-squared|||||||0.023
73959789|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|7.4||0.7387|ONE_SIDED|95.0|-17.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-17.1|0.7387
73959790|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|8.4||0.6286|ONE_SIDED|95.0|-16.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-16.8|0.6286
73959791|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.1|STANDARD_ERROR_OF_MEAN|8.3||0.9538|ONE_SIDED|95.0|-27.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-27.8|0.9538
73841688|NCT02951481|147232050|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73841689|NCT02951481|147232051|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
73841690|NCT02951481|147232052|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
73841691|NCT02951481|147232053|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
73841692|NCT02951481|147232054|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
73841693|NCT01051661|147232055|SUPERIORITY|The non-inferiority objective was met if the lower limit (LL) of the 95% CI for the Vaccine Efficacy Improvement (VEI) was \> -33%. Furthermore, the superiority objective was met if the LL of the 95% CI for the VEI was \>0.|Vaccine efficacy increase|76.7|||||TWO_SIDED|95.0|18.53|93.39||||||Evaluation of the relative protective efficacy of 2 doses of Arepanrix™ vaccine (Arepanrix 2D Group) compared to two doses of GSK2340273A vaccine (GSK2340273A Group) beginning 14 days after Dose 1 vaccination (for each subject enrolled) and continuing until study conclusion on Day 385.||93.39|18.53|
73841694|NCT01051661|147232083|OTHER||Adjusted GMT ratios|5.61|||||TWO_SIDED|95.0|4.92|6.41||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 2D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 2D Group/GSK2340273A Group).||6.41|4.92|
73863190|NCT03826342|147272485|SUPERIORITY|||||||0.4492|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.4492
73841695|NCT01051661|147232083|OTHER||Adjusted GMT ratios|1.05|||||TWO_SIDED|95.0|0.93|1.19||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 1D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 1D Group/GSK2340273A Group).||1.19|0.93|
73841696|NCT02412982|147232110|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||||||0.092
73841697|NCT00635050|147232116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|||||||||||||
73841698|NCT04011241|147232157|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|173.71|||||TWO_SIDED|90.0|154.58|195.21|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 17.6.|||195.21|154.58|
73841699|NCT04011241|147232158|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|137.4|||||TWO_SIDED|90.0|120.84|156.24|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 19.4.|||156.24|120.84|
73841700|NCT04011241|147232159|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|168.64|||||TWO_SIDED|90.0|145.59|195.34|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 18.1.|||195.34|145.59|
73841701|NCT00437073|147232176|SUPERIORITY_OR_OTHER||percentage of participants|38.0|||||TWO_SIDED|95.0|13.9|68.4|||||The estimated value indicates the percentage of participants with CNS OR in the Lapatinib plus Capecitabine treatment arm.|||68.4|13.9|
73841702|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.78|||||TWO_SIDED|95.0|0.66|0.92||||||Serotype 1: the ratio of GMT (GMR) (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.92|0.66|
73841703|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.89|||||TWO_SIDED|95.0|0.79|0.99||||||Serotype 3: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.99|0.79|
74022384|NCT01431287|147597104|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.161|STANDARD_ERROR_OF_MEAN|0.043||0.0002|TWO_SIDED|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.244|0.077|0.0002
73841704|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.79|||||TWO_SIDED|95.0|0.67|0.94||||||Serotype 4: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.94|0.67|
73841705|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||Serotype 5: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.91|0.65|
73841706|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.87|||||TWO_SIDED|95.0|0.73|1.05||||||Serotype 6A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.05|0.73|
73841707|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.91|||||TWO_SIDED|95.0|0.77|1.08||||||Serotype 6B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.08|0.77|
73841708|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.84|||||TWO_SIDED|95.0|0.75|0.93||||||Serotype 7F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.93|0.75|
73841709|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.88|||||TWO_SIDED|95.0|0.76|1.02||||||Serotype 9V: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.02|0.76|
73841710|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|1.09|||||TWO_SIDED|95.0|0.92|1.29||||||Serotype 14: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.29|0.92|
73841711|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.73|||||TWO_SIDED|95.0|0.62|0.85||||||Serotype 18C: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.85|0.62|
73863191|NCT03826342|147272486|SUPERIORITY|||||||0.0765|||||||t-test, 2 sided|||||||0.0765
73863192|NCT03826342|147272487|SUPERIORITY|||||||0.535|||||||t-test, 2 sided|||||||0.535
73898506|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|0.56|STANDARD_ERROR_OF_MEAN|0.34||0.545|TWO_SIDED|95.0|-0.762|1.441||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 96||1.441|-0.762|0.545
73898507|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
74022385|NCT01431287|147597104|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.045||0.0017|TWO_SIDED|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.228|0.053|0.0017
74022386|NCT01431287|147597104|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.042||0.0022|TWO_SIDED|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.210|0.046|0.0022
73841712|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.74|||||TWO_SIDED|95.0|0.63|0.86||||||Serotype 19A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.86|0.63|
73841713|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.64|||||TWO_SIDED|95.0|0.53|0.76||||||Serotype 19F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.76|0.53|
73841714|NCT04875533|147232192|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.8|||||TWO_SIDED|95.0|0.65|0.99||||||Serotype 23F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.99|0.65|
73841715|NCT04875533|147232193|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|0.58|||||TWO_SIDED|95.0|0.5|0.67||||||Serotype 8: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.67|0.50|
73841716|NCT04875533|147232193|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|2.14|||||TWO_SIDED|95.0|1.8|2.53||||||Serotype 10A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.53|1.80|
73841717|NCT04875533|147232193|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.72|||||TWO_SIDED|95.0|1.44|2.06||||||Serotype 11A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.06|1.44|
73841718|NCT04875533|147232193|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.68|||||TWO_SIDED|95.0|1.39|2.04||||||Serotype 12F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.04|1.39|
73841719|NCT04875533|147232193|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|2.13|||||TWO_SIDED|95.0|1.72|2.64||||||Serotype 15B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.64|1.72|
74022387|NCT01431287|147597104|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.176|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.259|0.093|<0.0001
73841720|NCT04875533|147232193|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.62|||||TWO_SIDED|95.0|1.33|1.98||||||Serotype 22F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.98|1.33|
73841721|NCT04875533|147232193|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.14|||||TWO_SIDED|95.0|0.97|1.34||||||Serotype 33F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.34|0.97|
73841722|NCT00330733|147232233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||Paired comparisons (follow-up vs baseline) and unpaired group comparisons were performed by Student's t tests or Wilcoxon signed rank tests.||||<0.05
73841723|NCT01979185|147232260|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.632|||||TWO_SIDED|90.0|0.538|0.744|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.744|0.538|
73841724|NCT01979185|147232261|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.63|||||TWO_SIDED|90.0|0.543|0.73|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.730|0.543|
73863193|NCT03826342|147272488|SUPERIORITY|||||||0.4302|||||||t-test, 2 sided|||||||0.4302
74022388|NCT01431287|147597104|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.044||0.0141|TWO_SIDED|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.194|0.022|0.0141
74022389|NCT01431287|147597104|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.043||0.4581|TWO_SIDED|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.118|-0.053|0.4581
74022390|NCT01431287|147597104|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.293|0.124|<0.0001
73841725|NCT01979185|147232262|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.594|||||TWO_SIDED|90.0|0.526|0.672|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.672|0.526|
73841726|NCT00980798|147232263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2365||||0.1212|TWO_SIDED|95.0|-0.5357|0.0627||No adjustment for multiple comparisons necessary, as only 1 primary hypothesis was tested. Threshold for statistical significance was 0.05.|Mixed-model regression analysis|The difference above is presented as the difference OROS hydromorphone HCl minus placebo, so negative scores favour OROS hydromorphone HCl.|The analysis was adjusted for baseline BPI item 5 score, time on study, and whether the primary affected joint was the hip or knee.|The F test for treatment tested the null hypothesis of no treatment difference. Assuming that 3 baseline measures and 7 post baseline measures were collected 81 patients were required per group to detect a difference of 1 point in the BPI measure with 90% power at a significance level of 5%. To allow for a drop-out rate of approximately 40%, the study planned to recruit 135 patients per group (i.e. 270 in total).||0.0627|-0.5357|0.1212
73841727|NCT01441492|147232276|OTHER|||||||0.804|||||||Chi-squared|||the study is powered to be able to detect a 15% difference in the ≥ Grade II complication rate between the drain and no drain groups. A total of 342 evaluable patients will be needed for the two study groups (n=171 per group) in order to achieve 80% power to detect a 15% increase or decrease in the complication rate with a significance level of 0.05.||||0.804
73841728|NCT04724837|147232286|SUPERIORITY|Two-sided p-value is presented. A p-value \<0.10 indicates statistical significance, which is consistent with a one-sided test at the 5% level.|Adjusted % mean change from baseline|-33.7|||<|0.001|TWO_SIDED|90.0|-42.5|-23.5|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + Placebo (PBO)||-23.5|-42.5|<0.001
73841729|NCT04724837|147232287|SUPERIORITY|Two-sided p-value is presented. A p-value \<0.10 indicates statistical significance, which is consistent with a one-sided test at the 5% level.|Adjusted % mean change from baseline|-27.0||||0.002|TWO_SIDED|90.0|-38.4|-13.6|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-13.6|-38.4|0.002
73841730|NCT04724837|147232288|SUPERIORITY||Least Square (LS) mean CFB|-3.6|||||TWO_SIDED|90.0|-6.8|-0.5|||Mixed Models Analysis||If mean change from baseline (CFB) \>0 then the result favours Dapa 10 mg + PBO for office systolic blood pressure.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.5|-6.8|
73841731|NCT04724837|147232288|SUPERIORITY||LS mean CFB|-7.6|||||TWO_SIDED|90.0|-10.3|-4.9|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office systolic blood pressure.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-4.9|-10.3|
73841732|NCT04724837|147232289|SUPERIORITY||LS Mean CFB|-3.0|||||TWO_SIDED|90.0|-5.0|-1.0|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office diastolic blood pressure.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-1.0|-5.0|
73841733|NCT04724837|147232289|SUPERIORITY||LS Mean CFB|-5.4|||||TWO_SIDED|90.0|-7.1|-3.7|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office diastolic blood pressure.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-3.7|-7.1|
73841734|NCT04724837|147232290|SUPERIORITY||Adjusted % mean change from baseline|-27.0|||||TWO_SIDED|90.0|-38.4|-13.6|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-13.6|-38.4|
73959792|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|7.3||0.5701|ONE_SIDED|95.0|-13.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-13.4|0.5701
73841735|NCT04724837|147232290|SUPERIORITY||Adjusted % mean change from baseline|-33.7|||||TWO_SIDED|90.0|-42.5|-23.5|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-23.5|-42.5|
73841736|NCT04724837|147232291|SUPERIORITY||LS mean CFB|1.1|||||TWO_SIDED|90.0|-0.5|2.6|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||2.6|-0.5|
73841737|NCT04724837|147232291|SUPERIORITY||LS mean CFB|-0.8|||||TWO_SIDED|90.0|-2.1|0.5|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.5|-2.1|
73841738|NCT04724837|147232291|SUPERIORITY||LS mean CFB|-1.2|||||TWO_SIDED|90.0|-2.8|0.5|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 12 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.5|-2.8|
73841739|NCT04724837|147232291|SUPERIORITY||LS mean CFB|-1.1|||||TWO_SIDED|90.0|-2.5|0.3|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 12 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.3|-2.5|
73841740|NCT04724837|147232291|SUPERIORITY||LS mean CFB|0.1|||||TWO_SIDED|90.0|-1.6|1.8|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 14 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||1.8|-1.6|
73841741|NCT04724837|147232291|SUPERIORITY||LS mean CFB|-2.1|||||TWO_SIDED|90.0|-3.5|-0.7|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 14 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.7|-3.5|
73841742|NCT04724837|147232293|SUPERIORITY||LS mean change|-2.2|||||TWO_SIDED|90.0|-4.0|-0.4|||Mixed Models Analysis||If mean change \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 and Week 12 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.4|-4.0|
73841743|NCT04724837|147232293|SUPERIORITY||LS mean change|-0.3|||||TWO_SIDED|90.0|-1.8|1.3|||Mixed Models Analysis||If mean change \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 and 12 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||1.3|-1.8|
73841744|NCT04197583|147232347|OTHER||Proportion by group|0.984|||||TWO_SIDED|95.0|0.948|0.995|||||For Tria subjects with stone management indication only|||0.995|0.948|
73841745|NCT00323622|147232356|SUPERIORITY_OR_OTHER||1 - (HR1/HR2)|16.8||||0.08|TWO_SIDED|95.0|-2.5|32.4||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - GSK RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||32.40|-2.50|0.08
73841746|NCT00323622|147232356|SUPERIORITY_OR_OTHER||1 - (HR1/HR2)|11.8||||0.43|TWO_SIDED|95.0|-20.11|35.18||The p-value presented is the Wald Chi-square p-value from the Cox regression model|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||35.18|-20.11|0.43
73841747|NCT00323622|147232357|SUPERIORITY_OR_OTHER||1 - (R1/R2)|14.9||||0.11|TWO_SIDED|95.0|-3.88|30.28||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||30.28|-3.88|0.11
73841748|NCT00323622|147232357|SUPERIORITY_OR_OTHER||1 - (R1/R2)|12.79||||0.35|TWO_SIDED|95.0|-16.27|34.59||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||34.59|-16.27|0.35
73841749|NCT00323622|147232358|SUPERIORITY_OR_OTHER||1 - (R1/R2)|19.42||||0.01|TWO_SIDED|95.0|4.62|31.93||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||31.93|4.62|0.01
73841750|NCT00323622|147232358|SUPERIORITY_OR_OTHER||1 - (R1/R2)|7.08||||0.54|TWO_SIDED|95.0|-17.37|26.44||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||26.44|-17.37|0.54
73841751|NCT00323622|147232359|SUPERIORITY_OR_OTHER||1 - (R1/R2)|16.79||||0.1|TWO_SIDED|95.0|-3.75|33.25||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||33.25|-3.75|0.10
73863194|NCT03826342|147272489|SUPERIORITY|||||||0.807|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.8070
74022391|NCT01431287|147597104|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.043||0.6335|TWO_SIDED|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.105|-0.064|0.6335
73863195|NCT02046070|147272506|OTHER|||||||0.4859|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.||||0.4859
73863196|NCT02046070|147272506|OTHER|||||||0.6757|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.||||0.6757
73841752|NCT00323622|147232359|SUPERIORITY_OR_OTHER||1 - (R1/R2)|6.31||||0.7|TWO_SIDED|95.0|-31.0|32.99||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||32.99|-31.00|0.70
73841753|NCT01342666|147232409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1154|STANDARD_ERROR_OF_MEAN|0.9057|<|0.0001|TWO_SIDED|95.0|3.2925|6.9383||We did only one comparison. The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided||We compare de mean difference of the delta (final-basal levels) between groups. The values posted are the difference found in the tomato group in comparison of the control group. The mean represent the increment of HDL-c in the tomato group.|We test the effect of two daily roma tomatoes during one month in HDL-c levels. We estimate the sample size to have a 80% study power.||6.9383|3.2925|<0.0001
73841754|NCT01342666|147232409|SUPERIORITY_OR_OTHER||Slope|5.656|STANDARD_ERROR_OF_MEAN|0.789|<|0.0001|TWO_SIDED|95.0|4.027|7.232||A priori p value of \<0.05|Regression, Linear|Adjusted for adherence, smoking, age, gender, waist to hip ratio, triglycerides, body mass index, exercise, omega 3, alcohol, fish, simple sugars.|Parameters of the model: F= 4.06; r = 0.798; r2 = 0.638; p=0.001|||7.232|4.027|<0.0001
73841755|NCT02296099|147232410|EQUIVALENCE|The Mann-Whitney U test was utilized.||||||0.014||||||The p-value was not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|There were no adjustments.||The null hypothesis is that there is no difference in the pain scores between the two groups.||||0.014
73841756|NCT04033640|147232431|OTHER||||||<|0.001|||||||K-sample test|The p-value was calculated using a nonparametric k-sample test on the equality of medians.||Comparison of SD Biosensor POC G6PD test results for capillary and venous samples||||<0.001
73841757|NCT00688740|147232436|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.795||||0.0043|TWO_SIDED|95.0|0.679|0.932||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank|||||0.932|0.679|0.0043
73841758|NCT00688740|147232437|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.742||||0.002|TWO_SIDED|95.0|0.613|0.898||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank|||||0.898|0.613|0.0020
73841759|NCT00856557|147232439|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is equal distribution of proportion of successful encounters among groups||||0.33
73841760|NCT00856557|147232439|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.724|STANDARD_ERROR_OF_MEAN|0.346||0.036|TWO_SIDED||||||Mixed Models Analysis|||Considering all encounters (n=179) of all physicians for who outcomes were measured (n=111) together, are encounters in which physicians contextualized the plan of care more likely to be associated with target health outcome achievement than encounters in which physicians did not, controlling for clustering of encounters within physicians. (Generalized logistic mixed model, with random intercept for physician)||||.036
73841761|NCT00856557|147232440|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.99
74022392|NCT01431287|147597104|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.047|STANDARD_ERROR_OF_MEAN|0.041||0.253|TWO_SIDED|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.034|-0.129|0.2530
74022393|NCT01431287|147597104|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.043||0.1188|TWO_SIDED|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.153|-0.017|0.1188
74022394|NCT01431287|147597105|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.041||0.0008|TWO_SIDED|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.217|0.057|0.0008
74022395|NCT01431287|147597105|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.043||0.0032|TWO_SIDED|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.209|0.042|0.0032
74022396|NCT01431287|147597105|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.04||0.0085|TWO_SIDED|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.183|0.027|0.0085
73841762|NCT00856557|147232441|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.39
73841763|NCT01432444|147232442|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was derived from Exact McNemar test.|McNemar|||Inpatient hospitalization for retrospective period (Months 4-6) and prospective period (Months 4-6) for closed or open unit.||||<.0001
73841764|NCT01432444|147232443|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, 12 and 24.||||<.0001
73841765|NCT01432444|147232444|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, Week 12 and Week 24.||||<.0001
73841766|NCT01432444|147232445|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analysis for Week 4, 12 and 24.||||<.0001
73841767|NCT01432444|147232446|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from t-test of mean=0.|t-test|||Statistical analysEs for Week 4, 12 and 24.||||<.0001
73841768|NCT02301897|147232457|SUPERIORITY|||||||0.0008|||||||Chi-Square Test|||||||0.0008
73841769|NCT02301897|147232457|SUPERIORITY||||||<|0.001|||||||Chi-Square Test|||||||<0.001
73841770|NCT02301897|147232458|SUPERIORITY|||||||0.0719|||||||Chi-Square Test|||||||0.0719
73841771|NCT02301897|147232458|SUPERIORITY|||||||0.0004|||||||Chi-Square Test|||||||0.0004
73841772|NCT02301897|147232459|SUPERIORITY|||||||0.0167|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1||||0.0167
73841773|NCT02301897|147232459|SUPERIORITY|||||||0.1257|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1||||0.1257
74022397|NCT01431287|147597105|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.04||0.0001|TWO_SIDED|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.235|0.077|0.0001
74022398|NCT01431287|147597105|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0255|TWO_SIDED|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.176|0.011|0.0255
74022399|NCT01431287|147597105|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.041||0.4393|TWO_SIDED|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.113|-0.049|0.4393
74022400|NCT01431287|147597105|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.188|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.269|0.108|<0.0001
74022401|NCT01431287|147597105|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.041||0.7784|TWO_SIDED|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.092|-0.069|0.7784
74022402|NCT01431287|147597105|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.039||0.1965|TWO_SIDED|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.026|-0.129|0.1965
74022403|NCT01431287|147597105|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.041||0.1315|TWO_SIDED|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.144|-0.019|0.1315
74022404|NCT01431287|147597106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.141|STANDARD_ERROR_OF_MEAN|0.56||0.0001|TWO_SIDED|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-1.043|-3.239|0.0001
74022405|NCT01431287|147597106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.131|STANDARD_ERROR_OF_MEAN|0.56||0.0435|TWO_SIDED|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.033|-2.230|0.0435
74022406|NCT01431287|147597106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.528|STANDARD_ERROR_OF_MEAN|0.559||0.0063|TWO_SIDED|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.432|-2.623|0.0063
74022407|NCT01431287|147597106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.517|STANDARD_ERROR_OF_MEAN|0.558||0.3545|TWO_SIDED|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.577|-1.611|0.3545
74022408|NCT01431287|147597106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.518|STANDARD_ERROR_OF_MEAN|0.559||0.3542|TWO_SIDED|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.578|-1.614|0.3542
74022409|NCT01431287|147597106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.613|STANDARD_ERROR_OF_MEAN|0.556||0.2697|TWO_SIDED|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.476|-1.702|0.2697
74022410|NCT01431287|147597106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.559||0.0434|TWO_SIDED|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.033|-2.227|0.0434
74022411|NCT01431287|147597106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.563||0.0732|TWO_SIDED|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.095|-2.114|0.0732
74022412|NCT01431287|147597106|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.011|STANDARD_ERROR_OF_MEAN|0.563||0.0724|TWO_SIDED|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.092|-2.114|0.0724
74022413|NCT01431287|147597106|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.563||0.9983|TWO_SIDED|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.104|-1.102|0.9983
74022414|NCT01431287|147597107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.852|STANDARD_ERROR_OF_MEAN|0.578||0.0014|TWO_SIDED|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.718|-2.985|0.0014
73841774|NCT02301897|147232459|SUPERIORITY|||||||0.9754|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1||||0.9754
73841775|NCT02301897|147232459|SUPERIORITY|||||||0.7672|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1||||0.7672
73841776|NCT02301897|147232459|SUPERIORITY|||||||0.2232|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2||||0.2232
73841777|NCT02301897|147232459|SUPERIORITY|||||||0.4512|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2||||0.4512
73841778|NCT02301897|147232459|SUPERIORITY|||||||0.3545|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU||||0.3545
73841779|NCT02301897|147232459|SUPERIORITY|||||||0.2482|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU||||0.2482
73841780|NCT02301897|147232460|SUPERIORITY|||||||0.0016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0016
73841781|NCT02301897|147232460|SUPERIORITY|||||||0.0003|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0003
73841782|NCT02301897|147232460|SUPERIORITY|||||||0.6666|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1||||0.6666
73841783|NCT02301897|147232460|SUPERIORITY|||||||0.3612|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1||||0.3612
73841784|NCT02301897|147232460|SUPERIORITY|||||||0.0309|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0309
73959793|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|10.0||0.9242|ONE_SIDED|95.0|-31.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-31.3|0.9242
74084251|NCT01525628|147721685|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|120.67|STANDARD_DEVIATION|58.3||0.4337|TWO_SIDED|90.0|83.68|174.01|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||174.01|83.68|0.4337
73841785|NCT02301897|147232460|SUPERIORITY|||||||0.0007|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0007
73841786|NCT02301897|147232460|SUPERIORITY|||||||0.0641|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU||||0.0641
73841787|NCT02301897|147232460|SUPERIORITY|||||||0.3743|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU||||0.3743
73841788|NCT02301897|147232461|SUPERIORITY|||||||0.0049|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0049
73841789|NCT02301897|147232461|SUPERIORITY|||||||0.0064|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0064
73841790|NCT02301897|147232461|SUPERIORITY|||||||0.5637|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5637
73841791|NCT02301897|147232461|SUPERIORITY|||||||0.0505|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0505
73841792|NCT02301897|147232461|SUPERIORITY|||||||0.4262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4262
73841793|NCT02301897|147232461|SUPERIORITY|||||||0.1419|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1419
73841794|NCT02301897|147232461|SUPERIORITY|||||||0.4497|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4497
73841795|NCT02301897|147232461|SUPERIORITY|||||||0.5371|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5371
73841796|NCT02301897|147232462|SUPERIORITY|||||||0.0069|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0069
73841797|NCT02301897|147232462|SUPERIORITY|||||||0.0059|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0059
73841798|NCT02301897|147232462|SUPERIORITY|||||||0.2117|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2117
73841799|NCT02301897|147232462|SUPERIORITY|||||||0.0006|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0006
73841800|NCT02301897|147232462|SUPERIORITY|||||||0.0788|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0788
73841801|NCT02301897|147232462|SUPERIORITY|||||||0.008|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0080
73841802|NCT02301897|147232462|SUPERIORITY|||||||0.1516|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.1516
73841803|NCT02301897|147232462|SUPERIORITY|||||||0.0565|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.0565
73841804|NCT02301897|147232463|SUPERIORITY|||||||0.011|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0110
73841805|NCT02301897|147232463|SUPERIORITY|||||||0.0601|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0601
73841806|NCT02301897|147232463|SUPERIORITY|||||||0.2168|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2168
73841807|NCT02301897|147232463|SUPERIORITY|||||||0.0101|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0101
73841808|NCT02301897|147232463|SUPERIORITY|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2430
73841809|NCT02301897|147232463|SUPERIORITY|||||||0.0843|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0843
73841810|NCT02301897|147232463|SUPERIORITY|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5570
73841811|NCT02301897|147232463|SUPERIORITY|||||||0.5302|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5302
73841812|NCT02301897|147232464|SUPERIORITY|||||||0.0504|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0504
73841813|NCT02301897|147232464|SUPERIORITY|||||||0.0151|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0151
73841814|NCT02301897|147232464|SUPERIORITY|||||||0.5932|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5932
73841815|NCT02301897|147232464|SUPERIORITY|||||||0.0831|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0831
73841816|NCT02301897|147232464|SUPERIORITY|||||||0.1416|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1416
73841817|NCT02301897|147232464|SUPERIORITY|||||||0.0392|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0392
73841818|NCT02301897|147232464|SUPERIORITY|||||||0.8275|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8275
73841819|NCT02301897|147232464|SUPERIORITY|||||||0.8733|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8733
73841820|NCT02301897|147232465|SUPERIORITY|||||||0.0651|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0651
73841821|NCT02301897|147232465|SUPERIORITY|||||||0.0298|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0298
73841822|NCT02301897|147232465|SUPERIORITY|||||||0.4005|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.4005
73841823|NCT02301897|147232465|SUPERIORITY|||||||0.1114|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.1114
73841824|NCT02301897|147232465|SUPERIORITY|||||||0.1318|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1318
73841825|NCT02301897|147232465|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0807
73841826|NCT02301897|147232465|SUPERIORITY|||||||0.4506|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4506
73841827|NCT02301897|147232465|SUPERIORITY|||||||0.4614|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4614
73841828|NCT02301897|147232466|SUPERIORITY|||||||0.0653|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0653
73841829|NCT02301897|147232466|SUPERIORITY|||||||0.048|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0480
73841830|NCT02301897|147232466|SUPERIORITY|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.4010
73841831|NCT02301897|147232466|SUPERIORITY|||||||0.0772|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0772
73841832|NCT02301897|147232466|SUPERIORITY|||||||0.3206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.3206
73841833|NCT02301897|147232466|SUPERIORITY|||||||0.1605|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1605
74084252|NCT01525628|147721686|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|397.73|STANDARD_DEVIATION|31.6||1|TWO_SIDED|90.0|330.79|478.22|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||478.22|330.79|1.0000
73841834|NCT02301897|147232466|SUPERIORITY|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5570
73841835|NCT02301897|147232466|SUPERIORITY|||||||0.3437|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.3437
73841836|NCT02301897|147232467|SUPERIORITY|||||||0.2624|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.2624
73841837|NCT02301897|147232467|SUPERIORITY|||||||0.0688|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0688
73841838|NCT02301897|147232467|SUPERIORITY|||||||0.279|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2790
73841839|NCT02301897|147232467|SUPERIORITY|||||||0.6541|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.6541
73841840|NCT02301897|147232467|SUPERIORITY|||||||0.8559|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.8559
73841841|NCT02301897|147232467|SUPERIORITY|||||||0.4326|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4326
73841842|NCT02301897|147232467|SUPERIORITY|||||||0.1052|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.1052
73841843|NCT02301897|147232467|SUPERIORITY|||||||0.9206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.9206
73841844|NCT02301897|147232468|SUPERIORITY|||||||0.1439|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.1439
73841845|NCT02301897|147232468|SUPERIORITY|||||||0.067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0670
73841846|NCT02301897|147232468|SUPERIORITY|||||||0.6761|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.6761
73841847|NCT02301897|147232468|SUPERIORITY|||||||0.0639|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0639
73841848|NCT02301897|147232468|SUPERIORITY|||||||0.2218|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2218
73841849|NCT02301897|147232468|SUPERIORITY|||||||0.4468|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4468
73841850|NCT02301897|147232468|SUPERIORITY|||||||0.7678|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.7678
73841851|NCT02301897|147232468|SUPERIORITY|||||||0.8922|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8922
73841852|NCT02301897|147232469|SUPERIORITY|||||||0.1262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.1262
73841853|NCT02301897|147232469|SUPERIORITY|||||||0.2075|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.2075
73841854|NCT02301897|147232469|SUPERIORITY|||||||0.5904|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5904
73841855|NCT02301897|147232469|SUPERIORITY|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2430
73841856|NCT02301897|147232469|SUPERIORITY|||||||0.7067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.7067
73841857|NCT02301897|147232469|SUPERIORITY|||||||0.2725|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2725
73841858|NCT02301897|147232469|SUPERIORITY|||||||0.7016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.7016
73841859|NCT02301897|147232469|SUPERIORITY|||||||0.8751|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8751
73841860|NCT02301897|147232470|SUPERIORITY|||||||0.0338|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0338
73841861|NCT02301897|147232470|SUPERIORITY|||||||0.0004|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0004
73841862|NCT02301897|147232470|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0807
73841863|NCT02301897|147232470|SUPERIORITY|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0142
73841864|NCT02301897|147232470|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0807
73841865|NCT02301897|147232470|SUPERIORITY|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0142
73841866|NCT02301897|147232470|SUPERIORITY|||||||0.1859|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug||||0.1859
73841867|NCT02301897|147232470|SUPERIORITY|||||||0.0896|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug||||0.0896
73841868|NCT00600340|147232472|NON_INFERIORITY|"Null hypothesis: Hazard Ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.042||||0.1983|ONE_SIDED|97.5||1.689||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).||1.689||0.1983
73841869|NCT00600340|147232472|NON_INFERIORITY|"Null hypothesis: Hazard Ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.018||||0.007|ONE_SIDED|97.5||1.261||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).||1.261||0.0070
73841870|NCT00600340|147232472|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.2024|ONE_SIDED|97.5||1.674||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).||1.674||0.2024
73841871|NCT00600340|147232472|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.134||||0.0612|ONE_SIDED|97.5||1.386||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).||1.386||0.0612
73841872|NCT00600340|147232473|NON_INFERIORITY|"Null hypothesis: Hazard ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.027||||0.1534|ONE_SIDED|97.5||1.606||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).||1.606||0.1534
73841873|NCT00600340|147232473|NON_INFERIORITY|"Null hypothesis: Hazard ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.035||||0.0085|ONE_SIDED|97.5||1.273||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).||1.273||0.0085
73841874|NCT00600340|147232473|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.1778|ONE_SIDED|97.5||1.623||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).||1.623||0.1778
73841875|NCT00600340|147232473|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.126||||0.049|ONE_SIDED|97.5||1.37||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).||1.37||0.049
73841876|NCT00600340|147232479|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.67||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR) of objective response and Cochran-Mantel-Haenszel (CMH) test (stratified)||0.67|0.33|< 0.0001
73863197|NCT02046070|147272507|OTHER|||||||0.9688|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR+PR rate=60% obtained using the one-sided Chi-Square test with alpha=0.10.||||0.9688
74084253|NCT01525628|147721686|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|142.27|STANDARD_DEVIATION|53.1||0.7346|TWO_SIDED|90.0|99.49|203.44|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||203.44|99.49|0.7346
73898508|NCT02880956|147328895|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.583||0.346|TWO_SIDED|95.0|-1.697|0.597||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.597|-1.697|0.346
73841877|NCT00600340|147232479|SUPERIORITY||Risk Difference (RD)|-17.0|||||TWO_SIDED|95.0|-24.0|-9.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-9|-24|
73841878|NCT00600340|147232479|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.43||||0.0006|TWO_SIDED|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.70|0.27|0.0006
73841879|NCT00600340|147232479|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-18.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-18|
73841880|NCT00600340|147232480|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.31|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.65|0.31|< 0.0001
73841881|NCT00600340|147232480|SUPERIORITY||Risk Difference (RD)|-18.0|||||TWO_SIDED|95.0|-26.0|-10.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-10|-26|
73841882|NCT00600340|147232480|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|TWO_SIDED|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.65|0.24|0.0003
73841883|NCT00600340|147232480|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-19.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-19|
73841884|NCT00600340|147232481|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.31|0.63||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.63|0.31|< 0.0001
73841885|NCT00600340|147232481|SUPERIORITY||Risk Difference (RD)|-20.0|||||TWO_SIDED|95.0|-28.0|-11.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-11|-28|
73841886|NCT00600340|147232481|SUPERIORITY||Odds Ratio (OR)|0.43||||0.0006|TWO_SIDED|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.70|0.27|0.0006
73841887|NCT00600340|147232481|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-18.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-18|
73841888|NCT00600340|147232482|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.6||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.60|0.29|< 0.0001
73841889|NCT00600340|147232482|SUPERIORITY||Risk Difference (RD)|-21.0|||||TWO_SIDED|95.0|-30.0|-13.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-13|-30|
73898509|NCT02880956|147328895|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73863198|NCT05601102|147272564|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.41|||||||t-test, 2 sided|||||||.41
73863199|NCT05601102|147272565|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.01|||||||t-test, 2 sided|||Anxiety subscale analysis||||.01
73898510|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.146||0.202|TWO_SIDED|95.0|-0.473|0.1||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.100|-0.473|0.202
73898511|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73863200|NCT05601102|147272565|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.42|||||||t-test, 2 sided|||Depression subscale||||.42
74084254|NCT01525628|147721687|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|403.86|STANDARD_DEVIATION|33.6||1|TWO_SIDED|90.0|332.19|490.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||490.99|332.19|1.0000
74084255|NCT01525628|147721687|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|116.96|STANDARD_DEVIATION|73.1||0.3968|TWO_SIDED|90.0|75.38|181.47|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||181.47|75.38|0.3968
74084256|NCT01525628|147721688|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|408.66|STANDARD_DEVIATION|45.9||1|TWO_SIDED|90.0|315.15|529.9|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||529.90|315.15|1.0000
74084257|NCT01525628|147721688|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|301.19|STANDARD_DEVIATION|62.1||0.9993|TWO_SIDED|90.0|204.61|443.35|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||443.35|204.61|0.9993
74084258|NCT01525628|147721689|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|450.51|STANDARD_DEVIATION|48.0||1|TWO_SIDED|90.0|343.67|590.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||590.57|343.67|1.0000
74084259|NCT01525628|147721689|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|341.96|STANDARD_DEVIATION|61.1||0.9996|TWO_SIDED|90.0|229.22|510.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||510.13|229.22|0.9996
74084260|NCT01525628|147721690|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|466.92|STANDARD_DEVIATION|47.6||1|TWO_SIDED|90.0|357.02|610.66|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||610.66|357.02|1.0000
74084261|NCT01525628|147721690|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|298.57|STANDARD_DEVIATION|79.2||0.9972|TWO_SIDED|90.0|187.22|476.15|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||476.15|187.22|0.9972
74084262|NCT01525628|147721691|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|528.95|STANDARD_DEVIATION|42.0||1|TWO_SIDED|90.0|415.88|672.75|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||672.75|415.88|1.0000
74084263|NCT01525628|147721691|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|384.0|STANDARD_DEVIATION|69.2||0.9998|TWO_SIDED|90.0|251.56|586.16|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||586.16|251.56|0.9998
73841890|NCT00600340|147232482|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|TWO_SIDED|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.65|0.24|0.0003
73841891|NCT00600340|147232482|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-19.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-19|
73863201|NCT05601102|147272566|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.04|||||||t-test, 2 sided|||||||.04
73863202|NCT05601102|147272567|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.15|||||||t-test, 2 sided|||||||.15
73863203|NCT05601102|147272568|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.02|||||||t-test, 2 sided|||||||.02
73863204|NCT05601102|147272569|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.22|||||||t-test, 2 sided|||||||.22
73841892|NCT00600340|147232483|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.32||||0.0066|TWO_SIDED|95.0|1.08|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.61|1.08|0.0066
73841893|NCT00600340|147232484|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.31||||0.0094|TWO_SIDED|95.0|1.07|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.61|1.07|0.0094
73841894|NCT00600340|147232485|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.13||||0.1957|TWO_SIDED|95.0|0.94|1.35||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.35|0.94|0.1957
73841895|NCT00600340|147232486|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.11||||0.2583|TWO_SIDED|95.0|0.92|1.34||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.34|0.92|0.2583
73841896|NCT00600340|147232487|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.57||||0.0001|TWO_SIDED|95.0|0.43|0.77||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||0.77|0.43|0.0001
73841897|NCT00600340|147232488|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.56||||0.0001|TWO_SIDED|95.0|0.41|0.75||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||0.75|0.41|0.0001
73841898|NCT00600340|147232489|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.41||||0.0582|TWO_SIDED|95.0|0.99|2.02||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||2.02|0.99|0.0582
73841899|NCT00600340|147232490|SUPERIORITY|HR is the hazard rate of Arm B divided by hazard rate of Arm A.|Hazard Ratio (HR)|1.45||||0.0429|TWO_SIDED|95.0|1.01|2.1||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Arm B divided by hazard rate of Arm A.|"HR of Arm B vs. Arm A for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||2.10|1.01|0.0429
73841900|NCT04770285|147232527|SUPERIORITY||Treatment Difference|-1.78||||0.0568|TWO_SIDED|95.0|-3.6|0.05|||MMRM|p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.||||0.05|-3.60|0.0568
73841901|NCT04770285|147232528|SUPERIORITY||Treatment Difference|-0.77||||0.0705|TWO_SIDED|95.0|-1.61|0.07|||MMRM|p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.||||0.07|-1.61|0.0705
73841902|NCT04770285|147232529|SUPERIORITY||Treatment Difference|-0.62||||0.3687|TWO_SIDED|95.0|-1.99|0.74||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||0.74|-1.99|0.3687
73841903|NCT04770285|147232529|SUPERIORITY||Treatment Difference|-1.45||||0.0828|TWO_SIDED|95.0|-3.1|0.19||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||0.19|-3.10|0.0828
73841904|NCT04770285|147232530|SUPERIORITY||Treatment Difference|-0.34||||0.3549|TWO_SIDED|95.0|-1.06|0.38||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||0.38|-1.06|0.3549
73841905|NCT04770285|147232530|SUPERIORITY||Treatment Difference|-0.28||||0.4948|TWO_SIDED|95.0|-1.09|0.53||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||0.53|-1.09|0.4948
73841906|NCT04770285|147232531|SUPERIORITY||Ratio of Response Rate|1.68||||0.142|TWO_SIDED|95.0|0.84|3.34||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 2||3.34|0.84|0.1420
73841907|NCT04770285|147232531|SUPERIORITY||Ratio of Response Rate|1.31||||0.2939|TWO_SIDED|95.0|0.79|2.16||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 4||2.16|0.79|0.2939
73841908|NCT04770285|147232531|SUPERIORITY||Ratio of Response Rate|1.38||||0.0884|TWO_SIDED|95.0|0.96|1.99||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 6||1.99|0.96|0.0884
73841909|NCT04770285|147232532|SUPERIORITY||Treatment Difference|-0.19||||0.0039|TWO_SIDED|95.0|-0.32|-0.06||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||-0.06|-0.32|0.0039
73841910|NCT04770285|147232532|SUPERIORITY||Treatment Difference|-0.32||||0.0003|TWO_SIDED|95.0|-0.5|-0.15||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||-0.15|-0.50|0.0003
73841911|NCT04770285|147232532|SUPERIORITY||Treatment Difference|-0.26||||0.0098|TWO_SIDED|95.0|-0.46|-0.06||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 6||-0.06|-0.46|0.0098
73841912|NCT04770285|147232533|SUPERIORITY||Treatment Difference|-1.02||||0.4463|TWO_SIDED|95.0|-3.66|1.61||p-value was calculated by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|ANCOVA|||||1.61|-3.66|0.4463
73841913|NCT04770285|147232534|SUPERIORITY||Treatment Difference|-1.29||||0.0102|TWO_SIDED|95.0|-2.28|-0.31||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||-0.31|-2.28|0.0102
73841914|NCT04770285|147232534|SUPERIORITY||Treatment Difference|-1.58||||0.0029|TWO_SIDED|95.0|-2.62|-0.54||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 6||-0.54|-2.62|0.0029
74084264|NCT01525628|147721692|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|569.81|STANDARD_DEVIATION|42.2||1|TWO_SIDED|90.0|447.49|725.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||725.57|447.49|1.0000
73841915|NCT04770285|147232535|SUPERIORITY||Ratio of Response Rate|1.18||||0.5757|TWO_SIDED|95.0|0.65|2.16||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 2||2.16|0.65|0.5757
73841916|NCT04770285|147232535|SUPERIORITY||Ratio of Response Rate|1.16||||0.5102|TWO_SIDED|95.0|0.75|1.78||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 4||1.78|0.75|0.5102
73841917|NCT04770285|147232535|SUPERIORITY||Ratio of Response Rate|1.15||||0.5342|TWO_SIDED|95.0|0.74|1.79||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 6||1.79|0.74|0.5342
73841918|NCT04770285|147232536|SUPERIORITY||Ratio of Response Rate|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Week 8||1.22|0.82|
73841919|NCT04770285|147232536|SUPERIORITY||Ratio of Response Rate|1.05|||||TWO_SIDED|95.0|0.88|1.25||||||Week 10||1.25|0.88|
73841920|NCT03766399|147232561|OTHER||LS means difference|-0.44||||0.9511|TWO_SIDED|90.0|-12.9|12.0|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Cohort 2||12.0|-12.9|0.9511
73841921|NCT03766399|147232561|OTHER||LS means difference|-7.87||||0.2849|TWO_SIDED|90.0|-20.3|4.59|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 2 Vs Part 2a (MAD) Placebo||4.59|-20.3|0.2849
73841922|NCT03766399|147232561|OTHER||LS means difference|-8.31||||0.2595|TWO_SIDED|90.0|-20.8|4.14|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Placebo||4.14|-20.8|0.2595
73841923|NCT03766399|147232561|OTHER||LS means difference|-3.04||||0.3604|TWO_SIDED|90.0|-8.6|2.51|||Linear Mixed Model|||Comparison of Part 3a (DPI/PoM) Vs Part 3a (DPI/PoM) Placebo||2.51|-8.60|0.3604
73841924|NCT03766399|147232562|OTHER||LS means difference|-25.4||||0.7544|TWO_SIDED|90.0|-166.0|115.0|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Cohort 2||115|-166|0.7544
73841925|NCT03766399|147232562|OTHER||LS means difference|-73.3||||0.375|TWO_SIDED|90.0|-214.0|67.6|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 2 Vs Part 2a (MAD) Placebo||67.6|-214|0.3750
73841926|NCT03766399|147232562|OTHER||LS means difference|-98.7||||0.2377|TWO_SIDED|90.0|-240.0|42.3|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Placebo||42.3|-240|0.2377
73841927|NCT03766399|147232562|OTHER||LS means difference|-50.4||||0.1105|TWO_SIDED|90.0|-102.0|1.61|||Linear Mixed Model|||Comparison of Part 3a (DPI/PoM) Vs Part 3a (DPI/PoM) Placebo||1.61|-102|0.1105
73841928|NCT03895372|147232585|SUPERIORITY||Risk Difference (RD)|8.87||||0.2621|TWO_SIDED|90.0|-4.5|26.26||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||26.26|-4.50|0.2621
73841929|NCT03895372|147232585|SUPERIORITY||Risk Difference (RD)|4.76||||0.2621|TWO_SIDED|90.0|-7.07|21.48||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||21.48|-7.07|0.2621
73863205|NCT05601102|147272570|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.29|||||||t-test, 2 sided|||||||.29
73841930|NCT03895372|147232585|SUPERIORITY||Risk Difference (RD)|33.02||||0.0004|TWO_SIDED|90.0|18.01|47.11||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||47.11|18.01|0.0004
73841931|NCT03895372|147232585|SUPERIORITY||Risk Difference (RD)|46.46|||<|0.0001|TWO_SIDED|90.0|30.62|60.56||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||60.56|30.62|<0.0001
73841932|NCT03895372|147232593|SUPERIORITY||Risk Difference (RD)|3.9|||||TWO_SIDED|90.0|-11.82|23.42||||||The analysis was based on the data at Week 16.||23.42|-11.82|
73841933|NCT03895372|147232593|SUPERIORITY||Risk Difference (RD)|-4.76|||||TWO_SIDED|90.0|-18.61|13.29||||||The analysis was based on the data at Week 16.||13.29|-18.61|
73841934|NCT03895372|147232593|SUPERIORITY||Risk Difference (RD)|32.38|||||TWO_SIDED|90.0|14.32|47.52||||||The analysis was based on the data at Week 16.||47.52|14.32|
73841935|NCT03895372|147232593|SUPERIORITY||Risk Difference (RD)|58.89|||||TWO_SIDED|90.0|41.01|72.41||||||The analysis was based on the data at Week 16.||72.41|41.01|
73841936|NCT03895372|147232594|SUPERIORITY||Risk Difference (RD)|1.52|||||TWO_SIDED|90.0|-14.52|20.77||||||The analysis was based on the data at Week 16.||20.77|-14.52|
73841937|NCT03895372|147232594|SUPERIORITY||Risk Difference (RD)|-2.38|||||TWO_SIDED|90.0|-17.67|17.01||||||The analysis was based on the data at Week 16.||17.01|-17.67|
73841938|NCT03895372|147232594|SUPERIORITY||Risk Difference (RD)|27.78|||||TWO_SIDED|90.0|8.86|43.26||||||The analysis was based on the data at Week 16.||43.26|8.86|
73841939|NCT03895372|147232594|SUPERIORITY||Risk Difference (RD)|54.07|||||TWO_SIDED|90.0|36.46|68.27||||||The analysis was based on the data at Week 16.||68.27|36.46|
73841940|NCT03895372|147232595|SUPERIORITY||Risk Difference (RD)|1.52|||||TWO_SIDED|90.0|-14.52|20.77||||||The analysis was based on the data at Week 16.||20.77|-14.52|
73841941|NCT03895372|147232595|SUPERIORITY||Risk Difference (RD)|-2.38|||||TWO_SIDED|90.0|-17.67|17.01||||||The analysis was based on the data at Week 16.||17.01|-17.67|
73841942|NCT03895372|147232595|SUPERIORITY||Risk Difference (RD)|27.78|||||TWO_SIDED|90.0|8.86|43.26||||||The analysis was based on the data at Week 16.||43.26|8.86|
73841943|NCT03895372|147232595|SUPERIORITY||Risk Difference (RD)|54.07|||||TWO_SIDED|90.0|36.46|68.27||||||The analysis was based on the data at Week 16.||68.27|36.46|
73841944|NCT03895372|147232598|SUPERIORITY||Least Squares Mean Difference|-1.46|||||TWO_SIDED|90.0|-5.42|2.51||||||The analysis was based on the data at Week 16.||2.51|-5.42|
73841945|NCT03895372|147232598|SUPERIORITY||Least Squares Mean Difference|-3.54|||||TWO_SIDED|90.0|-7.5|0.42||||||The analysis was based on the data at Week 16.||0.42|-7.50|
73841946|NCT03895372|147232598|SUPERIORITY||Least Squares Mean Difference|-9.8|||||TWO_SIDED|90.0|-13.05|-6.56||||||The analysis was based on the data at Week 16.||-6.56|-13.05|
73841947|NCT03895372|147232598|SUPERIORITY||Least Squares Mean Difference|-12.33|||||TWO_SIDED|90.0|-15.61|-9.04||||||The analysis was based on the data at Week 16.||-9.04|-15.61|
73841948|NCT03895372|147232599|SUPERIORITY||Least Squares Mean Difference|-8.63|||||TWO_SIDED|90.0|-23.61|6.35||||||The analysis was based on the data at Week 16.||6.35|-23.61|
73841949|NCT03895372|147232599|SUPERIORITY||Least Squares Mean Difference|-13.02|||||TWO_SIDED|90.0|-27.98|1.94||||||The analysis was based on the data at Week 16.||1.94|-27.98|
73841950|NCT03895372|147232599|SUPERIORITY||Least Squares Mean Difference|-40.74|||||TWO_SIDED|90.0|-53.02|-28.46||||||The analysis was based on the data at Week 16.||-28.46|-53.02|
73841951|NCT03895372|147232599|SUPERIORITY||Least Squares Mean Difference|-53.04|||||TWO_SIDED|90.0|-65.44|-40.63||||||The analysis was based on the data at Week 16.||-40.63|-65.44|
73841952|NCT03895372|147232600|SUPERIORITY||Least Squares Mean Difference|-1.22|||||TWO_SIDED|90.0|-2.52|0.09||||||The analysis was based on the data at Week 16.||0.09|-2.52|
73841953|NCT03895372|147232600|SUPERIORITY||Least Squares Mean Difference|-1.21|||||TWO_SIDED|90.0|-2.46|0.05||||||The analysis was based on the data at Week 16.||0.05|-2.46|
73841954|NCT03895372|147232600|SUPERIORITY||Least Squares Mean Difference|-3.47|||||TWO_SIDED|90.0|-4.51|-2.43||||||The analysis was based on the data at Week 16.||-2.43|-4.51|
73841955|NCT03895372|147232600|SUPERIORITY||Least Squares Mean Difference|-3.66|||||TWO_SIDED|90.0|-4.71|-2.61||||||The analysis was based on the data at Week 16.||-2.61|-4.71|
73841956|NCT03895372|147232601|SUPERIORITY||Risk Difference (RD)|12.99|||||TWO_SIDED|90.0|-4.52|32.87||||||The analysis was based on the data at Week 16.||32.87|-4.52|
73841957|NCT03895372|147232601|SUPERIORITY||Risk Difference (RD)|23.81|||||TWO_SIDED|90.0|2.62|44.64||||||The analysis was based on the data at Week 16.||44.64|2.62|
73841958|NCT03895372|147232601|SUPERIORITY||Risk Difference (RD)|41.27|||||TWO_SIDED|90.0|23.47|56.18||||||The analysis was based on the data at Week 16.||56.18|23.47|
73841959|NCT03895372|147232601|SUPERIORITY||Risk Difference (RD)|49.13|||||TWO_SIDED|90.0|30.62|63.69||||||The analysis was based on the data at Week 16.||63.69|30.62|
73841960|NCT03895372|147232602|SUPERIORITY||Least Squares Mean Difference|-4.21|||||TWO_SIDED|90.0|-7.82|-0.59||||||The analysis was based on the data at Week 16.||-0.59|-7.82|
73841961|NCT03895372|147232602|SUPERIORITY||Least Squares Mean Difference|-6.44|||||TWO_SIDED|90.0|-9.89|-2.99||||||The analysis was based on the data at Week 16.||-2.99|-9.89|
73841962|NCT03895372|147232602|SUPERIORITY||Least Squares Mean Difference|-10.51|||||TWO_SIDED|90.0|-13.4|-7.62||||||The analysis was based on the data at Week 16.||-7.62|-13.40|
73841963|NCT03895372|147232602|SUPERIORITY||Least Squares Mean Difference|-10.81|||||TWO_SIDED|90.0|-13.68|-7.94||||||The analysis was based on the data at Week 16.||-7.94|-13.68|
73841964|NCT01472185|147232614|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.36||P-value is from a mixed effects model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||-0.36|-0.76|< 0.0001
73841965|NCT05889468|147232619|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test, a non-parametric test, was used since the empirical distribution of data did not follow the normality assumption.||This was an intention-to-treat analysis.||||0.49
73841966|NCT05889468|147232620|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Intention-to-treat analysis||||0.32
73841967|NCT05889468|147232622|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Intention-to-treat analysis||||>0.99
73841968|NCT05889468|147232623|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Intention-to-treat analysis||||>0.99
73841969|NCT05468918|147232630|OTHER|||||||0.002|||||||ANOVA|||||||0.002
73841970|NCT05468918|147232631|OTHER|||||||0.023|||||||ANOVA|||||||0.023
73841971|NCT00049543|147232704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.14|TWO_SIDED|95.0|0.94|1.64|||Log Rank|||The Kaplan-Meier estimates of survival distribution for overall survival by treatment arm are reported, and the log rank test stratified by the stratification factors at randomization (exclude center) was used to compare the difference in the overall survival between two treatment arms. Hazard ratio of comparison of study treatment arm to placebo and it 95% C.I. were reported.||1.64|0.94|0.14
73841972|NCT00049543|147232705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.15|TWO_SIDED|95.0|0.93|1.61||Stratified by stratification factors at randomization (except center)|Log Rank|Stratified by stratification factors at randomization (except center)||||1.61|0.93|0.15
73841973|NCT04562090|147232718|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.73|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-4.3|-3.16||Repeated Measures Analysis (RMA): CFB as response, treatment group (TG), visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 12||-3.16|-4.30|<0.001
73841974|NCT04562090|147232721|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.62|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-3.25|-1.99||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.99|-3.25|<0.001
73841975|NCT04562090|147232721|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.47|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.93|-2.02||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-2.02|-2.93|<0.001
73841976|NCT04562090|147232721|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.13|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.96|-2.3||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.30|-3.96|<0.001
73841977|NCT04562090|147232721|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-3.39|-2.47||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.47|-3.39|<0.001
73841978|NCT04562090|147232721|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.47|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-4.37|-2.56||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-2.56|-4.37|<0.001
73841979|NCT04562090|147232721|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.59|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-4.06|-3.12||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-3.12|-4.06|<0.001
73841980|NCT04562090|147232722|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.66|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.88|-0.44||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.44|-0.88|<0.001
73841981|NCT04562090|147232722|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.81|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.97|-0.65||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.65|-0.97|<0.001
73841982|NCT04562090|147232722|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.88|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.17|-0.58||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.58|-1.17|<0.001
73841983|NCT04562090|147232722|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.94|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.78||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.78|-1.10|<0.001
73841984|NCT04562090|147232722|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.35|-0.71||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.71|-1.35|<0.001
73841985|NCT04562090|147232722|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.98|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.14|-0.81||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.81|-1.14|<0.001
73841986|NCT04562090|147232723|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.58|-0.37||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.37|-0.58|<0.001
73841987|NCT04562090|147232723|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.46|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.53|-0.38||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.38|-0.53|<0.001
73841988|NCT04562090|147232723|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.67|-0.39||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.39|-0.67|<0.001
73841989|NCT04562090|147232723|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.45|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.52|-0.37||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.37|-0.52|<0.001
73841990|NCT04562090|147232723|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.68|-0.38||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.38|-0.68|<0.001
73841991|NCT04562090|147232723|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.52|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.6|-0.45||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.45|-0.60|<0.001
73841992|NCT04562090|147232724|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-1.31|-0.9||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.90|-1.31|<0.001
73841993|NCT04562090|147232724|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.11|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.25|-0.96||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.96|-1.25|<0.001
73841994|NCT04562090|147232724|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.26|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.53|-0.99||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.99|-1.53|<0.001
73841995|NCT04562090|147232724|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.34|-1.05||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-1.05|-1.34|<0.001
73841996|NCT04562090|147232724|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.25|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.54|-0.96||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.96|-1.54|<0.001
73898512|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.144||0.76|TWO_SIDED|95.0|-0.327|0.239||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.239|-0.327|0.760
73841997|NCT04562090|147232724|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.42|-1.12||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-1.12|-1.42|<0.001
73841998|NCT04562090|147232725|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-3.5|-2.43||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 4||-2.43|-3.50|<0.001
73841999|NCT04562090|147232725|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.05|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-3.44|-2.65||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 4||-2.65|-3.44|<0.001
73842000|NCT04562090|147232725|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-5.09|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-5.8|-4.39||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 8||-4.39|-5.80|<0.001
73842001|NCT04562090|147232725|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-4.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-4.7|-3.9||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 8||-3.90|-4.70|<0.001
73898513|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898514|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.147||0.419|TWO_SIDED|95.0|-0.409|0.17||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.170|-0.409|0.419
73959794|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.4|STANDARD_ERROR_OF_MEAN|9.8||0.9876|ONE_SIDED|95.0|-38.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-38.8|0.9876
73863206|NCT05601102|147272571|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||1|||||||t-test, 2 sided|||||||1.00
73863207|NCT05601102|147272572|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.6|||||||t-test, 2 sided|||||||.60
73842002|NCT04562090|147232725|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-6.01|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-6.78|-5.24||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 12||-5.24|-6.78|<0.001
73842003|NCT04562090|147232725|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-5.4|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-5.82|-4.98||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 12||-4.98|-5.82|<0.001
73842004|NCT04562090|147232726|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.97|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.73|-1.21||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.21|-2.73|<0.001
73842005|NCT04562090|147232726|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.36|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.9|-1.81||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.81|-2.90|<0.001
73842006|NCT04562090|147232726|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.2|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-4.2|-2.2||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.20|-4.20|<0.001
73842007|NCT04562090|147232726|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-3.47|-2.37||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.37|-3.47|<0.001
73842008|NCT03312543|147232737|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.18|STANDARD_DEVIATION|0.328|<|0.001|TWO_SIDED|95.0|0.09|0.26|||t-test, 2 sided|||||0.26|0.09|<0.001
73842009|NCT03312543|147232737|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.341|<|0.001|TWO_SIDED|95.0|0.21|0.39|||t-test, 2 sided|||||0.39|0.21|<0.001
73842010|NCT03312543|147232737|OTHER|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.025|TWO_SIDED|95.0|0.02|0.25|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.25|0.02|0.025
73898515|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|1.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898516|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.173||0.893|TWO_SIDED|95.0|-0.363|0.317||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.317|-0.363|0.893
73898517|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|||||
73898518|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.168||0.886|TWO_SIDED|95.0|-0.306|0.354||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.354|-0.306|0.886
73898519|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|1.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73842011|NCT03312543|147232738|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.349|<|0.001|TWO_SIDED|95.0|0.11|0.29|||t-test, 2 sided|||||0.29|0.11|<0.001
73842012|NCT03312543|147232738|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.328|<|0.001|TWO_SIDED|95.0|0.13|0.31|||t-test, 2 sided|||||0.31|0.13|<0.001
73842013|NCT03312543|147232738|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.062||0.54|TWO_SIDED|95.0|-0.09|0.16|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.16|-0.09|0.540
73842014|NCT03312543|147232739|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.532||0.627|TWO_SIDED|95.0|-0.17|0.1|||t-test, 2 sided|||||0.10|-0.17|0.627
73842015|NCT03312543|147232739|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.21|STANDARD_DEVIATION|0.5||0.002|TWO_SIDED|95.0|0.08|0.34|||t-test, 2 sided|||||0.34|0.08|0.002
73842016|NCT03312543|147232739|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.092||0.009|TWO_SIDED|95.0|0.06|0.42|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.42|0.06|0.009
73842017|NCT03312543|147232740|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.36|STANDARD_DEVIATION|0.465|<|0.001|TWO_SIDED|95.0|0.23|0.48|||t-test, 2 sided|||||0.48|0.23|<0.001
73842018|NCT03312543|147232740|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.47|STANDARD_DEVIATION|0.578|<|0.001|TWO_SIDED|95.0|0.32|0.63|||t-test, 2 sided|||||0.63|0.32|<0.001
73842019|NCT03312543|147232740|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.094||0.224|TWO_SIDED|95.0|-0.07|0.3|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.30|-0.07|0.224
73842020|NCT04983979|147232798|OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.752|0.552||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.552|-0.752|
73842021|NCT04983979|147232799|OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-1.97|0.65|||||Only the mean difference for the study end (week 12) is presented here|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.65|-1.97|
73842022|NCT04983979|147232800|OTHER||Mean Difference (Final Values)|25.15|||||TWO_SIDED|95.0|-48.83|99.13|||||Difference in change in systolic blood pressure between study arms.|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||99.13|-48.83|
73842023|NCT04983979|147232800|OTHER||Mean Difference (Final Values)|8.78|||||TWO_SIDED|95.0|-22.92|40.47|||||Difference in change in diastolic blood pressure between study arms.|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||40.47|-22.92|
73842024|NCT04983979|147232801|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.174|0.674||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.674|-0.174|
73842025|NCT04983979|147232802|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.00|0.00|
73842026|NCT04983979|147232803|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.174|0.674||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.674|-0.174|
73842027|NCT04983979|147232804|OTHER||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-19.5|11.4||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||11.4|-19.5|
73842028|NCT05293314|147232815|OTHER|Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.|receiver operating characteristic|0.964|||<|0.05|TWO_SIDED|95.0|0.932|0.996|||Wilcoxon (Mann-Whitney)|||Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.||0.996|0.932|<0.05
73842029|NCT05293314|147232815|OTHER|Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.|receiver operating characteristic|0.932|||<|0.05|TWO_SIDED|95.0|0.879|0.982|||Wilcoxon (Mann-Whitney)|||Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.||0.982|0.879|<0.05
73842030|NCT05293314|147232816|OTHER|Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.|Sensitivity|86.2|||||TWO_SIDED|95.0|77.1|95.2||||||Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.||95.2|77.1|
73842031|NCT05293314|147232816|OTHER|Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.|Sensitivity|86.2|||||TWO_SIDED|95.0|77.1|95.2||||||Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.||95.2|77.1|
73863208|NCT05601102|147272573|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||1|||||||t-test, 2 sided|||||||1.00
73842032|NCT05293314|147232817|OTHER|Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.|Specificity|92.5|||||TWO_SIDED|95.0|86.2|98.8||||||Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.||98.8|86.2|
73842033|NCT05293314|147232817|OTHER|Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.|Specificity|73.9|||||TWO_SIDED|95.0|56.0|91.9||||||Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.||91.9|56|
73842034|NCT00835367|147232818|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.84||||||90.0|98.22|105.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.59|98.22|
73842035|NCT00835367|147232819|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|102.53||||||90.0|99.71|105.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.44|99.71|
73842036|NCT00835367|147232820|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.49||||||90.0|99.75|105.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.30|99.75|
73842037|NCT00835367|147232821|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|91.79||||||90.0|84.83|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||99.32|84.83|
73842038|NCT00835367|147232822|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.85||||||90.0|92.54|99.27|||||Metabolite presented for informational purposes only.|||99.27|92.54|
73842039|NCT00835367|147232823|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.3|102.3|||||Metabolite presented for informational purposes only|||102.30|98.30|
74084265|NCT01525628|147721692|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|441.89|STANDARD_DEVIATION|66.9||0.9999|TWO_SIDED|90.0|286.81|680.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||680.82|286.81|0.9999
73842040|NCT00835367|147232824|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.74||||||90.0|100.35|105.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.19|100.35|
73842041|NCT00835367|147232825|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.72||||||90.0|100.3|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.20|100.30|
74022415|NCT01431287|147597107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.444|STANDARD_ERROR_OF_MEAN|0.576||0.4413|TWO_SIDED|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.686|-1.573|0.4413
73842042|NCT00835367|147232826|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.25|102.35|||||Metabolite presented for informational purposes only.|||102.35|98.25|
73842043|NCT01373281|147232829|SUPERIORITY_OR_OTHER_LEGACY||Vaccine efficacy|56.5|||||TWO_SIDED|95.0|43.8|66.4||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow \& Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.||66.4|43.8|
73842044|NCT01373281|147232832|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|55.4|||||TWO_SIDED|95.0|47.3|62.3||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||62.3|47.3|
73842045|NCT01373281|147232833|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|57.9|||||TWO_SIDED|95.0|49.0|65.2||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||65.2|49.0|
73842046|NCT01373281|147232834|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|54.8|||||TWO_SIDED|95.0|46.8|61.7||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||61.7|46.8|
73842047|NCT00734032|147232849|SUPERIORITY||Ratio|0.514|||<|0.001|TWO_SIDED|95.0|0.449|0.59|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 40 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.590|0.449|<.001
73842048|NCT00734032|147232849|SUPERIORITY||Ratio|0.421|||<|0.001|TWO_SIDED|95.0|0.367|0.483|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 80 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.483|0.367|<.001
73842049|NCT00734032|147232849|SUPERIORITY||Ratio|0.326|||<|0.001|TWO_SIDED|95.0|0.284|0.375|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 160 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.375|0.284|<.001
73842050|NCT00863304|147232883|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.65|-0.62||P-value was based on pairwise comparisons.|ANCOVA|||Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.62|-1.65|<0.001
73842051|NCT00863304|147232883|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.26||0.002|TWO_SIDED|95.0|-1.32|-0.29||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.29|-1.32|0.002
73842052|NCT00863304|147232883|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.26||0.09|TWO_SIDED|95.0|-0.96|0.07||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.07|-0.96|0.090
73842053|NCT00863304|147232883|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.26||0.009|TWO_SIDED|95.0|-1.21|-0.17||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.17|-1.21|0.009
73842054|NCT00863304|147232883|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.26||0.175|TWO_SIDED|95.0|-0.87|0.16||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.87|0.175
73842055|NCT00863304|147232884|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.71|-0.75||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.75|-1.71|<0.001
73898520|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.172||0.306|TWO_SIDED|95.0|-0.515|0.162||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.162|-0.515|0.306
74022416|NCT01431287|147597107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.437|STANDARD_ERROR_OF_MEAN|0.578||0.0129|TWO_SIDED|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.304|-2.569|0.0129
74022417|NCT01431287|147597107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.574||0.9222|TWO_SIDED|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.070|-1.182|0.9222
73842056|NCT00863304|147232884|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.48|-0.51||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.51|-1.48|<0.001
73842057|NCT00863304|147232884|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.25||0.067|TWO_SIDED|95.0|-0.94|0.03||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.94|0.067
73842058|NCT00863304|147232884|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.25||0.002|TWO_SIDED|95.0|-1.26|-0.29||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.29|-1.26|0.002
73842059|NCT00863304|147232884|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.25||0.031|TWO_SIDED|95.0|-1.03|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-1.03|0.031
73842060|NCT00863304|147232885|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.5|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.50|<0.001
73842061|NCT00863304|147232885|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-0.48|<0.001
73842062|NCT00863304|147232885|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.078|TWO_SIDED|95.0|-0.3|0.02||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.02|-0.30|0.078
73863209|NCT05601102|147272574|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed|||||<|0.001|||||||t-test, 2 sided|||||||<.001
73863210|NCT04908280|147272586|SUPERIORITY|||||||0.0308|||||||ANOVA|||||||0.0308
73842063|NCT00863304|147232885|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.019|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.019
73842064|NCT00863304|147232885|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.029|TWO_SIDED|95.0|-0.34|-0.02||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.02|-0.34|0.029
73842065|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.029|TWO_SIDED|95.0|-0.94|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.94|0.029
73842066|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.214|TWO_SIDED|95.0|-0.73|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.73|0.214
73842067|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.21|<0.001
73842068|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.234|TWO_SIDED|95.0|-0.18|0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.72|-0.18|0.234
73842069|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.23||0.034|TWO_SIDED|95.0|0.04|0.93||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.93|0.04|0.034
73842070|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.63|-0.7||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.70|-1.63|<0.001
73842071|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.42|-0.49||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.49|-1.42|<0.001
73842072|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.007|TWO_SIDED|95.0|-1.11|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-1.11|0.007
73842073|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.029|TWO_SIDED|95.0|-0.99|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.99|0.029
73898521|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|1.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73842074|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.24||0.193|TWO_SIDED|95.0|-0.78|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.78|0.193
73842075|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.68|-0.73||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.73|-1.68|<0.001
73842076|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.24||0.001|TWO_SIDED|95.0|-1.28|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.28|0.001
73842077|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.011|TWO_SIDED|95.0|-1.1|-0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.14|-1.10|0.011
73842078|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.06|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-1.06|0.017
73842079|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.24||0.464|TWO_SIDED|95.0|-0.66|0.3||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.30|-0.66|0.464
73842080|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.72|-0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.72|-1.72|<0.001
73863211|NCT03344640|147272627|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.875|TWO_SIDED|90.0|-8.84|7.3|||LS mean|LS mean change from baseline in WORC total percentage score||All Patients at day 99||7.30|-8.84|0.875
73842081|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.55|-0.54||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.54|-1.55|<0.001
73842082|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.26||0.014|TWO_SIDED|95.0|-1.14|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-1.14|0.014
73842083|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.26||0.023|TWO_SIDED|95.0|-1.09|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-1.09|0.023
73842084|NCT00863304|147232886|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.26||0.114|TWO_SIDED|95.0|-0.92|0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.10|-0.92|0.114
73842085|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.029|TWO_SIDED|95.0|-0.94|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.94|0.029
73842086|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.214|TWO_SIDED|95.0|-0.73|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.73|0.214
73842087|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.21|<0.001
73842088|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.234|TWO_SIDED|95.0|-0.18|0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.72|-0.18|0.234
73842089|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.23||0.034|TWO_SIDED|95.0|0.04|0.93||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.93|0.04|0.034
73842090|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.59|-0.67||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.67|-1.59|<0.001
73842091|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.37|-0.45||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.45|-1.37|<0.001
73842092|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.24||0.012|TWO_SIDED|95.0|-1.05|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-1.05|0.012
73842093|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.24||0.023|TWO_SIDED|95.0|-1.0|-0.07||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.07|-1.00|0.023
73842094|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.175|TWO_SIDED|95.0|-0.78|0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.14|-0.78|0.175
73842095|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.55|-0.63||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.63|-1.55|<0.001
73842096|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.34|-0.41||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.41|-1.34|<0.001
73842097|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.03|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-1.03|0.017
73842098|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.027|TWO_SIDED|95.0|-0.99|-0.06||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.06|-0.99|0.027
73842099|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.24||0.19|TWO_SIDED|95.0|-0.78|0.15||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.15|-0.78|0.190
73842100|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.63|-0.68||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.68|-1.63|<0.001
74084266|NCT01525628|147721693|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|606.29|STANDARD_DEVIATION|44.2||1|TWO_SIDED|90.0|471.42|779.74|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||779.74|471.42|1.0000
73842101|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.55|-0.6||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.60|-1.55|<0.001
73842102|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.034|TWO_SIDED|95.0|-0.99|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.99|0.034
73842103|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|9.0|-1.12|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.12|0.009
73842104|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.023|TWO_SIDED|95.0|-1.04|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-1.04|0.023
73842105|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.6|-0.64||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.64|-1.60|<0.001
73842106|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.35|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.35|<0.001
73842107|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.25||0.092|TWO_SIDED|95.0|-0.9|0.07||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.07|-0.90|0.092
73842108|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.25||0.004|TWO_SIDED|95.0|-1.19|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.19|0.004
73842109|NCT00863304|147232887|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.25||0.064|TWO_SIDED|95.0|-0.94|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.94|0.064
73842110|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|-1.12|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.12|0.001
73842111|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.003|TWO_SIDED|95.0|-1.09|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.09|0.003
73842112|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.25|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.25|<0.001
73842113|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.22||0.572|TWO_SIDED|95.0|-0.31|0.55||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.55|-0.31|0.572
73842114|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.22||0.467|TWO_SIDED|95.0|-0.27|0.59||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.59|-0.27|0.467
73842115|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.74|-0.83||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.83|-1.74|<0.001
73842116|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.58|-0.66||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.66|-1.58|<0.001
73842117|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.19|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.19|0.002
73863212|NCT03344640|147272628|SUPERIORITY||Difference and 90% CI versus placebo|3.97||||0.19|TWO_SIDED|90.0|-1.03|8.97|||LS mean|LS mean change from baseline in WORC total percentage score||All patientts at day 15||8.97|-1.03|0.190
73842118|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.019|TWO_SIDED|95.0|-1.01|-0.09||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.09|-1.01|0.019
73842119|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.101|TWO_SIDED|95.0|-0.85|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.85|0.101
73842120|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.7|-0.78||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.78|-1.70|<0.001
73842121|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.47|-0.54||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.54|-1.47|<0.001
73842122|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|95.0|-1.08|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.08|0.009
73842123|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.08|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.08|0.008
73842124|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.101|TWO_SIDED|95.0|-0.85|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.85|0.101
73842125|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.79|-0.83||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.83|-1.79|<0.001
73842126|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.63|-0.67||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.67|-1.63|<0.001
73842127|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.21|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-1.21|0.003
73842128|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.25||0.016|TWO_SIDED|95.0|-1.08|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-1.08|0.016
74022418|NCT01431287|147597107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.029|STANDARD_ERROR_OF_MEAN|0.576||0.9602|TWO_SIDED|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.100|-1.157|0.9602
73842129|NCT00863304|147232888|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.25||0.082|TWO_SIDED|95.0|-0.91|0.06||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.06|-0.91|0.082
74022419|NCT01431287|147597107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.415|STANDARD_ERROR_OF_MEAN|0.57||0.4669|TWO_SIDED|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.703|-1.533|0.4669
73842130|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|-1.12|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.12|0.001
73842131|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.003|TWO_SIDED|95.0|-1.09|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.09|0.003
73842132|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.25|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.25|<0.001
73842133|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.22||0.572|TWO_SIDED|95.0|-0.31|0.55||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.55|-0.31|0.572
74022420|NCT01431287|147597107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.471|STANDARD_ERROR_OF_MEAN|0.575||0.4126|TWO_SIDED|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.656|-1.598|0.4126
73842134|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.22||0.467|TWO_SIDED|95.0|-0.27|0.59||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.59|-0.27|0.467
73842135|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.73|-0.82||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.82|-1.73|<0.001
73842136|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.61|-0.7||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.70|-1.61|<0.001
73842137|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.23||0.003|TWO_SIDED|95.0|-1.16|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-1.16|0.003
73842138|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.015|TWO_SIDED|95.0|-1.03|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-1.03|0.015
73842139|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.23||0.053|TWO_SIDED|95.0|-0.91|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.91|0.053
73842140|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.66|-0.75||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.75|-1.66|<0.001
74084267|NCT01525628|147721693|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|377.98|STANDARD_DEVIATION|82.0||0.9994|TWO_SIDED|90.0|233.48|611.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||611.91|233.48|0.9994
73842141|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.56|-0.65||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.65|-1.56|<0.001
73842142|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.23||0.009|TWO_SIDED|95.0|-1.07|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.07|0.009
73842143|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.011|TWO_SIDED|95.0|-1.05|-0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.14|-1.05|0.011
73842144|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.035|TWO_SIDED|95.0|-0.95|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.95|0.035
73842145|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.79|-0.85||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.85|-1.79|<0.001
73842146|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.71|-0.76||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.76|-1.71|<0.001
73842147|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.11|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.11|0.008
73842148|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.24||0.005|TWO_SIDED|95.0|-1.16|-0.21||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.21|-1.16|0.005
73842149|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.013|TWO_SIDED|95.0|-1.07|-0.12||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.12|-1.07|0.013
73842150|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.76|-0.81||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.81|-1.76|<0.001
73898522|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.116||0.008|TWO_SIDED|95.0|-0.535|-0.079||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.079|-0.535|0.008
73898523|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|-0.26|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73842151|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.58|-0.63||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.63|-1.58|<0.001
73842152|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.24||0.05|TWO_SIDED|95.0|-0.95|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.00|-0.95|0.050
73842153|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.29|-0.34||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.34|-1.29|<0.001
73842154|NCT00863304|147232889|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|95.0|-1.11|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.11|0.009
73842155|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.35|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.35|0.012
73842156|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.113|TWO_SIDED|95.0|-0.28|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.28|0.113
73842157|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.49|<0.001
73842158|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.01|0.29||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.29|-0.01|0.076
73842159|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.007|TWO_SIDED|95.0|0.06|0.37||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.37|0.06|0.007
73842160|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.56|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-0.56|<0.001
73842161|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.58|-0.26||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.26|-0.58|<0.001
73842162|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-0.43|<0.001
73842163|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.102|TWO_SIDED|95.0|-0.29|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.29|0.102
73842164|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.066|TWO_SIDED|95.0|-0.31|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.31|0.066
73842165|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.28||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.28|-0.60|<0.001
73842166|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.53|-0.21||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.21|-0.53|<0.001
73842167|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|-0.34|-0.02||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.02|-0.34|0.027
73842168|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.001|TWO_SIDED|95.0|-0.42|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-0.42|0.001
73842169|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.020
73842170|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.17||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.17|-0.49|<0.001
73863213|NCT03344640|147272628|SUPERIORITY||Difference and 90% CI versus placebo|3.97|||||TWO_SIDED|90.0|-3.39|9.11|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 29||9.11|-3.39|
73842171|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08||0.001|TWO_SIDED|95.0|-0.43|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-0.43|0.001
73842172|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.328|TWO_SIDED|95.0|-0.24|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.24|0.328
73842173|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.41|-0.09||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.09|-0.41|0.002
73842174|NCT00863304|147232890|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.022|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.022
73842175|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.35|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.35|0.012
73842176|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.113|TWO_SIDED|95.0|-0.28|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.28|0.113
73842177|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.49|<0.001
73842178|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.01|0.29||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.29|-0.01|0.076
73842179|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.007|TWO_SIDED|95.0|0.06|0.37||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.37|0.06|0.007
73842180|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.26||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.26|-0.57|<0.001
73842181|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
73842182|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.45|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-0.45|<0.001
73842183|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.12|TWO_SIDED|95.0|-0.29|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.29|0.120
73842184|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.126|TWO_SIDED|95.0|-0.29|0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.04|-0.29|0.126
73842185|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.62|-0.3||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.30|-0.62|<0.001
73842186|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
73842187|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.41|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-0.41|0.003
73842188|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.009|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.38|0.009
73842189|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.052|TWO_SIDED|95.0|-0.32|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.00|-0.32|0.052
73863214|NCT03344640|147272628|SUPERIORITY||Difference and 90% CI versus placebo|0.761||||0.761|TWO_SIDED|90.0|-8.81|6.08|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 57||6.08|-8.81|0.761
73842190|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
73842191|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.15||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.15|-0.48|<0.001
73842192|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.051|TWO_SIDED|95.0|-0.33|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.00|-0.33|0.051
73842193|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.41|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-0.41|0.003
73842194|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.069|TWO_SIDED|95.0|-0.32|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.32|0.069
73842195|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-0.57|<0.001
73842196|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.20|-0.53|<0.001
73842197|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.37|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.37|0.012
73842198|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.36|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.36|0.020
73842199|NCT00863304|147232891|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.064|TWO_SIDED|95.0|-0.32|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.32|0.064
73842200|NCT00023595|147232937|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.12|TWO_SIDED|95.0|0.72|1.04|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.04|0.72|0.12
73842201|NCT00023595|147232938|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.97|0.73|0.02
73842202|NCT00023595|147232939|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.9|TWO_SIDED|95.0|0.84|1.17|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.17|0.84|0.90
73842203|NCT00023595|147232940|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio, log|0.79||||0.006|TWO_SIDED|95.0|0.66|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.93|0.66|0.006
73842204|NCT00023595|147232941|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.05|TWO_SIDED|95.0|0.66|1.0|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.00|0.66|0.05
73842205|NCT00023595|147232942|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.64|0.85|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.85|0.64|<0.001
73842206|NCT00023595|147232943|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.64|0.82|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.82|0.64|<0.001
73842207|NCT00023595|147232944|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.79|1.26|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.26|0.79|0.98
73842208|NCT00023595|147232945|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.19||||0.008|TWO_SIDED|95.0|1.35|7.52|||Regression, Logistic||Odds Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||7.52|1.35|0.008
73842209|NCT00023595|147232946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.275|TWO_SIDED|95.0|0.78|2.41|||Regression, Logistic||Odds Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||2.41|0.78|0.275
73842210|NCT00023595|147232947|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.03|TWO_SIDED|95.0|0.71|0.98|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.98|0.71|0.030
73842211|NCT00023595|147232948|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.401|TWO_SIDED|95.0|0.89|1.31|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.31|0.89|0.401
73842212|NCT00023595|147232949|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.93|0.71|0.002
73842213|NCT00023595|147232965|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.51|0.71|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.71|0.51|<0.001
73842214|NCT00023595|147232966|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.414|TWO_SIDED|95.0|0.73|1.13|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.13|0.73|0.414
73842215|NCT00023595|147232967|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.55|0.73|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.73|0.55|<0.001
73842216|NCT00023595|147232968|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.108|TWO_SIDED|95.0|0.72|1.03|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.03|0.72|0.108
73842217|NCT00023595|147232969|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.717|TWO_SIDED|95.0|0.83|1.32|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.32|0.83|0.717
73842218|NCT00023595|147232970|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.018|TWO_SIDED|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.97|0.73|0.018
73842219|NCT00023595|147232986|SUPERIORITY|||||||0.015||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.015
73842220|NCT00023595|147232986|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
73842221|NCT00023595|147232986|SUPERIORITY|||||||0.011||||||24 months|Chi-squared|||||||0.011
73842222|NCT00023595|147232986|SUPERIORITY|||||||0.44||||||36 months|Chi-squared|||||||0.44
73842223|NCT00023595|147232987|SUPERIORITY|||||||0.91||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.91
73842224|NCT00023595|147232987|SUPERIORITY|||||||0.62||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.62
73842225|NCT00023595|147232987|SUPERIORITY|||||||0.04||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.04
73842226|NCT00023595|147232987|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
73842227|NCT00023595|147232987|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
73842228|NCT00023595|147232988|SUPERIORITY|||||||0.31||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.31
73842229|NCT00023595|147232988|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
73842230|NCT00023595|147232988|SUPERIORITY|24 months||||||0.028|||||||Chi-squared|||||||0.028
73842231|NCT00023595|147232988|SUPERIORITY|||||||0.079||||||36 months|Chi-squared|||||||0.079
73842232|NCT00023595|147232989|SUPERIORITY|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.74
73842233|NCT00023595|147232989|SUPERIORITY|||||||0.61||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.61
73842234|NCT00023595|147232989|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
73842235|NCT00023595|147232989|SUPERIORITY|||||||0.94||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.94
73842236|NCT00023595|147232989|SUPERIORITY|||||||0.29||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.29
73842237|NCT00023595|147232990|SUPERIORITY|||||||0.063||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.063
73842238|NCT00023595|147232990|SUPERIORITY|||||||0.187||||||12 months|Chi-squared|||||||0.187
73842239|NCT00023595|147232990|SUPERIORITY|||||||0.168||||||24 months|Chi-squared|||||||0.168
73842240|NCT00023595|147232990|SUPERIORITY|||||||0.05||||||36 months|Chi-squared|||||||0.050
73842241|NCT00023595|147232991|SUPERIORITY|||||||0.82||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.82
73842242|NCT00023595|147232991|SUPERIORITY|||||||0.48||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.48
73842243|NCT00023595|147232991|SUPERIORITY|||||||0.69||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.69
73842244|NCT00023595|147232991|SUPERIORITY|||||||0.63||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.63
73842245|NCT00023595|147232991|SUPERIORITY|||||||0.9||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.90
73842246|NCT00023595|147232992|SUPERIORITY|||||||0.039||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.039
73842247|NCT00023595|147232992|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
73842248|NCT00023595|147232992|SUPERIORITY|||||||0.008||||||24 months|Chi-squared|||||||0.008
73898524|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.115||0.031|TWO_SIDED|95.0|-0.474|-0.023||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.023|-0.474|0.031
73842249|NCT00023595|147232992|SUPERIORITY|||||||0.31||||||36 months|Chi-squared|||||||0.31
73842250|NCT00023595|147232993|SUPERIORITY|||||||0.36||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.36
73842251|NCT00023595|147232993|SUPERIORITY|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.87
73842252|NCT00023595|147232993|SUPERIORITY|||||||0.17||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.17
73842253|NCT00023595|147232993|SUPERIORITY|||||||0.12||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.12
73842254|NCT00023595|147232993|SUPERIORITY|||||||0.79||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.79
73842255|NCT00023595|147232994|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|||||||<0.001
73842256|NCT00023595|147232994|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
73842257|NCT00023595|147232994|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
73842258|NCT00023595|147232994|SUPERIORITY||||||<|0.024||||||36 months|Chi-squared|||||||<0.024
73842259|NCT00023595|147232995|SUPERIORITY|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.31
73842260|NCT00023595|147232995|SUPERIORITY|||||||0.42||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.42
73842261|NCT00023595|147232995|SUPERIORITY|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.66
73842262|NCT00023595|147232995|SUPERIORITY|||||||0.32||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.32
73842263|NCT00023595|147232995|SUPERIORITY|||||||0.43||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.43
73842264|NCT00023595|147232996|SUPERIORITY|||||||0.051||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.051
73842265|NCT00023595|147232996|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
73842266|NCT00023595|147232996|SUPERIORITY|||||||0.065||||||24 months|Chi-squared|||||||0.065
73842267|NCT00023595|147232996|SUPERIORITY|||||||0.83||||||36 months|Chi-squared|||||||0.83
73842268|NCT00023595|147232997|SUPERIORITY|||||||0.71||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.71
73842269|NCT00023595|147232997|SUPERIORITY|||||||0.57||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.57
73842270|NCT00023595|147232997|SUPERIORITY|||||||0.15||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.15
73842271|NCT00023595|147232997|SUPERIORITY|||||||0.64||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.64
73842272|NCT00023595|147232997|SUPERIORITY|||||||0.07||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.07
73842273|NCT00023595|147232998|SUPERIORITY|||||||0.004||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.004
73842274|NCT00023595|147232998|SUPERIORITY|||||||0.011||||||12 months|Chi-squared|||||||0.011
73842275|NCT00023595|147232998|SUPERIORITY|||||||0.007||||||24 months|Chi-squared|||||||0.007
73842276|NCT00023595|147232998|SUPERIORITY|||||||0.044||||||36 months|Chi-squared|||||||0.044
73842277|NCT00023595|147232999|SUPERIORITY|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.74
74022421|NCT01431287|147597107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.408|STANDARD_ERROR_OF_MEAN|0.583||0.0158|TWO_SIDED|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.265|-2.551|0.0158
73842278|NCT00023595|147232999|SUPERIORITY|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.87
73842279|NCT00023595|147232999|SUPERIORITY|||||||0.03||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.03
73842280|NCT00023595|147232999|SUPERIORITY|||||||0.6||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.60
73842281|NCT00023595|147232999|SUPERIORITY|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.87
73842282|NCT00023595|147233000|SUPERIORITY|||||||0.05||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.050
73842283|NCT00023595|147233000|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
73842284|NCT00023595|147233000|SUPERIORITY|24 months||||||0.049|||||||Chi-squared|||||||0.049
73842285|NCT00023595|147233000|SUPERIORITY|||||||0.097||||||36 months|Chi-squared|||||||0.097
73842286|NCT00023595|147233001|SUPERIORITY|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.40
73842287|NCT00023595|147233001|SUPERIORITY|||||||0.13||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.13
73842288|NCT00023595|147233001|SUPERIORITY|||||||0.86||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.86
73842289|NCT00023595|147233001|SUPERIORITY|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.89
73842290|NCT00023595|147233001|SUPERIORITY|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.87
73842291|NCT00023595|147233002|SUPERIORITY|||||||0.005||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.005
73842292|NCT00023595|147233002|SUPERIORITY|||||||0.023||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.023
73842293|NCT00023595|147233002|SUPERIORITY|||||||0.009||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.009
73842294|NCT00023595|147233002|SUPERIORITY|||||||0.26||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.26
73842295|NCT00023595|147233003|SUPERIORITY|||||||0.38||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.38
73842296|NCT00023595|147233003|SUPERIORITY|||||||0.45||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.45
73842297|NCT00023595|147233003|SUPERIORITY|||||||0.62||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.62
73842298|NCT00023595|147233003|SUPERIORITY|||||||0.82||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.82
73842299|NCT00023595|147233003|SUPERIORITY|||||||0.94||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.94
73842300|NCT00023595|147233004|SUPERIORITY|||||||0.205||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.205
73842301|NCT00023595|147233004|SUPERIORITY|||||||0.017||||||12 months|Chi-squared|||||||0.017
73842302|NCT00023595|147233004|SUPERIORITY|||||||0.028||||||24 months|Chi-squared|||||||0.028
73842303|NCT00023595|147233004|SUPERIORITY|||||||0.123||||||36 months|Chi-squared|||||||0.123
73842304|NCT00023595|147233005|SUPERIORITY|||||||0.19||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.19
73842305|NCT00023595|147233005|SUPERIORITY|||||||0.07||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.07
73842306|NCT00023595|147233005|SUPERIORITY|||||||0.94||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.94
73842307|NCT00023595|147233005|SUPERIORITY|||||||0.67||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.67
73842308|NCT00023595|147233005|SUPERIORITY|||||||0.44||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.44
73842309|NCT00023595|147233006|SUPERIORITY|||||||0.05||||||4 months|Chi-squared|P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.050
73842310|NCT00023595|147233006|SUPERIORITY|||||||0.006||||||12 months|Chi-squared|||||||0.006
73842311|NCT00023595|147233006|SUPERIORITY|||||||0.039||||||24 months|Chi-squared|||||||0.039
73842312|NCT00023595|147233006|SUPERIORITY|||||||0.074||||||36 months|Chi-squared|||||||0.074
73842313|NCT00023595|147233007|SUPERIORITY|||||||0.23||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.23
73842314|NCT00023595|147233007|SUPERIORITY|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.43
73842315|NCT00023595|147233007|SUPERIORITY|||||||0.35||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.35
73842316|NCT00023595|147233007|SUPERIORITY|||||||0.9||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.90
73842317|NCT00023595|147233007|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
73842318|NCT00023595|147233008|SUPERIORITY|||||||0.085||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.085
73842319|NCT00023595|147233008|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
73842320|NCT00023595|147233008|SUPERIORITY|||||||0.026||||||24 months|Chi-squared|||||||0.026
73842321|NCT00023595|147233008|SUPERIORITY|||||||0.085||||||36 months|Chi-squared|||||||0.085
73842322|NCT00023595|147233009|SUPERIORITY|||||||0.18||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.18
73842323|NCT00023595|147233009|SUPERIORITY|||||||0.17||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.17
73842324|NCT00023595|147233009|SUPERIORITY|||||||0.59||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.59
73842325|NCT00023595|147233009|SUPERIORITY|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.78
73842326|NCT00023595|147233009|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
73842327|NCT00023595|147233010|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
73842328|NCT00023595|147233010|SUPERIORITY||||||<|0.001||||||12 month|Chi-squared|||||||<0.001
73842329|NCT00023595|147233010|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
73842330|NCT00023595|147233010|SUPERIORITY|||||||0.018||||||36 months|Chi-squared|||||||0.018
73842331|NCT00023595|147233011|SUPERIORITY|||||||0.7||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.70
73842332|NCT00023595|147233011|SUPERIORITY|||||||0.47||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.47
73842333|NCT00023595|147233011|SUPERIORITY|||||||0.87||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.87
73842334|NCT00023595|147233011|SUPERIORITY|||||||0.84||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.84
73842335|NCT00023595|147233011|SUPERIORITY|||||||0.82||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.82
73842336|NCT00023595|147233012|SUPERIORITY|||||||0.023||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.023
73842337|NCT00023595|147233012|SUPERIORITY|||||||0.001||||||12 months|Chi-squared|||||||0.001
73842338|NCT00023595|147233012|SUPERIORITY|||||||0.077||||||24 months|Chi-squared|||||||0.077
73959795|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.1|STANDARD_ERROR_OF_MEAN|8.7||0.9802|ONE_SIDED|95.0|-32.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-32.5|0.9802
73842339|NCT00023595|147233012|SUPERIORITY|||||||0.17||||||36 months|Chi-squared|||||||0.170
73842340|NCT00023595|147233013|SUPERIORITY|||||||0.63||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.63
73842341|NCT00023595|147233013|SUPERIORITY|||||||0.29||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.29
73842342|NCT00023595|147233013|SUPERIORITY|||||||0.68||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.68
73842343|NCT00023595|147233013|SUPERIORITY|||||||0.25||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.25
73842344|NCT00023595|147233013|SUPERIORITY|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.68
73842345|NCT00023595|147233014|SUPERIORITY|||||||0.033||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.033
73842346|NCT00023595|147233014|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
73842347|NCT00023595|147233014|SUPERIORITY|||||||0.015||||||24 months|Chi-squared|||||||0.015
73842348|NCT00023595|147233014|SUPERIORITY|||||||0.051||||||36 months|Chi-squared|||||||0.051
73842349|NCT00023595|147233015|SUPERIORITY|||||||0.26||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.26
73842350|NCT00023595|147233015|SUPERIORITY|||||||0.23||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.23
73842351|NCT00023595|147233015|SUPERIORITY|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.66
73842352|NCT00023595|147233015|SUPERIORITY|||||||0.98||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.98
73842353|NCT00023595|147233015|SUPERIORITY|||||||0.86||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.86
73842354|NCT00023595|147233016|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
73842355|NCT00023595|147233016|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73842356|NCT00023595|147233016|SUPERIORITY|||||||0.006||||||24 months|Chi-squared|||||||0.006
73842357|NCT00023595|147233016|SUPERIORITY|||||||0.037||||||36 months|Chi-squared|||||||0.037
73842358|NCT00023595|147233017|SUPERIORITY|||||||0.53||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.53
73842359|NCT00023595|147233017|SUPERIORITY|||||||0.26||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.26
73842360|NCT00023595|147233017|SUPERIORITY|||||||0.76||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.76
73842361|NCT00023595|147233017|SUPERIORITY|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.89
73842362|NCT00023595|147233017|SUPERIORITY|||||||0.89||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.89
73842363|NCT00023595|147233018|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
73842364|NCT00023595|147233018|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
73842365|NCT00023595|147233018|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
73842366|NCT00023595|147233018|SUPERIORITY|||||||0.01||||||36 months|Chi-squared|||||||0.010
73842367|NCT00023595|147233019|SUPERIORITY|||||||0.01||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.01
73842368|NCT00023595|147233019|SUPERIORITY|||||||0.74||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.74
73842369|NCT00023595|147233019|SUPERIORITY|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.77
73842370|NCT00023595|147233019|SUPERIORITY|||||||0.46||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.46
73842371|NCT00023595|147233019|SUPERIORITY|||||||0.27||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.27
73842372|NCT00023595|147233020|SUPERIORITY|||||||0.029||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.029
73842373|NCT00023595|147233020|SUPERIORITY|||||||0.042||||||12 months|Chi-squared|||||||0.042
73842374|NCT00023595|147233020|SUPERIORITY|||||||0.3||||||24 months|Chi-squared|||||||0.30
73842375|NCT00023595|147233020|SUPERIORITY|||||||0.2||||||36 months|Chi-squared|||||||0.20
73842376|NCT00023595|147233021|SUPERIORITY|||||||0.98||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.98
73842377|NCT00023595|147233021|SUPERIORITY|||||||0.16||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.16
73842378|NCT00023595|147233021|SUPERIORITY|||||||0.88||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.88
73842379|NCT00023595|147233021|SUPERIORITY|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.95
73842380|NCT00023595|147233021|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
73842381|NCT00023595|147233022|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
73842382|NCT00023595|147233022|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
73842383|NCT00023595|147233022|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
73842384|NCT00023595|147233022|SUPERIORITY|||||||0.001||||||36 months|Chi-squared|||||||0.001
73842385|NCT00023595|147233023|SUPERIORITY|||||||0.86||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.86
73842386|NCT00023595|147233023|SUPERIORITY|||||||0.39||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.39
73842387|NCT00023595|147233023|SUPERIORITY|||||||0.65||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.65
73842388|NCT00023595|147233023|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
73842389|NCT00023595|147233023|SUPERIORITY|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.68
73842390|NCT00023595|147233024|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
73842391|NCT00023595|147233024|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
73842392|NCT00023595|147233024|SUPERIORITY|||||||0.001||||||24 months|Chi-squared|||||||0.001
73842393|NCT00023595|147233024|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
73842394|NCT00023595|147233025|SUPERIORITY|||||||0.96||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.96
73842395|NCT00023595|147233025|SUPERIORITY|||||||0.53||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.53
73842396|NCT00023595|147233025|SUPERIORITY|||||||0.37||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.37
73842397|NCT00023595|147233025|SUPERIORITY|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.78
73842398|NCT00023595|147233025|SUPERIORITY|||||||0.21||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.21
73842399|NCT00023595|147233026|SUPERIORITY|||||||0.007||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.007
73842400|NCT00023595|147233026|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
73842401|NCT00023595|147233026|SUPERIORITY|||||||0.023||||||24 months|Chi-squared|||||||0.023
73842402|NCT00023595|147233026|SUPERIORITY|||||||0.06||||||36 months|Chi-squared|||||||0.060
73842403|NCT00023595|147233027|SUPERIORITY|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.31
73842404|NCT00023595|147233027|SUPERIORITY|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.43
73842405|NCT00023595|147233027|SUPERIORITY|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.57
73842406|NCT00023595|147233027|SUPERIORITY|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.95
73842407|NCT00023595|147233027|SUPERIORITY|||||||0.38||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.38
73842408|NCT00023595|147233028|SUPERIORITY|||||||0.86||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.86
73842409|NCT00023595|147233028|SUPERIORITY|||||||0.78||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.78
73842410|NCT00023595|147233028|SUPERIORITY|||||||0.55||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.55
73842411|NCT00023595|147233028|SUPERIORITY|||||||0.027||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.027
73842412|NCT00023595|147233028|SUPERIORITY|||||||0.031||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.031
73842413|NCT00023595|147233029|SUPERIORITY|||||||0.4||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.40
73842414|NCT00023595|147233029|SUPERIORITY|||||||0.42||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.42
73842415|NCT00023595|147233029|SUPERIORITY|||||||0.41||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.41
73842416|NCT00023595|147233029|SUPERIORITY|||||||0.25||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.25
73842417|NCT00023595|147233029|SUPERIORITY|||||||0.25||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.25
73842418|NCT00023595|147233030|SUPERIORITY|||||||0.002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.002
73842419|NCT00023595|147233030|SUPERIORITY|||||||0.007||||||12 months|Chi-squared|||||||0.007
73842420|NCT00023595|147233030|SUPERIORITY|||||||0.049||||||24 months|Chi-squared|||||||0.049
73842421|NCT00023595|147233030|SUPERIORITY|||||||0.038||||||36 months|Chi-squared|||||||0.038
73842422|NCT00023595|147233031|SUPERIORITY|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.40
73842423|NCT00023595|147233031|SUPERIORITY|||||||0.37||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.37
73842424|NCT00023595|147233031|SUPERIORITY|||||||0.98||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.98
73842425|NCT00023595|147233031|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
73842426|NCT00023595|147233031|SUPERIORITY|||||||0.04||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.04
73842427|NCT00023595|147233032|SUPERIORITY|||||||0.036||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.036
73842428|NCT00023595|147233032|SUPERIORITY|||||||0.043||||||12 months|Chi-squared|||||||0.043
73842429|NCT00023595|147233032|SUPERIORITY|||||||0.018||||||24 months|Chi-squared|||||||0.018
73842430|NCT00023595|147233032|SUPERIORITY|||||||0.037||||||36 months|Chi-squared|||||||0.037
73842431|NCT00023595|147233033|SUPERIORITY|||||||0.75||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.75
73842432|NCT00023595|147233033|SUPERIORITY|||||||0.72||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.72
73842433|NCT00023595|147233033|SUPERIORITY|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.77
73842434|NCT00023595|147233033|SUPERIORITY|||||||0.52||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.52
73842435|NCT00023595|147233033|SUPERIORITY|||||||0.12||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.12
73842436|NCT00023595|147233034|SUPERIORITY|||||||0.0002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.0002
73842437|NCT00023595|147233034|SUPERIORITY||||||<|0.0001||||||12 months|Chi-squared|||||||<0.0001
73842438|NCT00023595|147233034|SUPERIORITY|||||||0.009||||||24 months|Chi-squared|||||||0.009
73842439|NCT00023595|147233034|SUPERIORITY|||||||0.32||||||36 months|Chi-squared|||||||0.32
73842440|NCT00023595|147233035|SUPERIORITY|||||||0.6||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.60
73842441|NCT00023595|147233035|SUPERIORITY|||||||0.14||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.14
73842442|NCT00023595|147233035|SUPERIORITY|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.57
73842443|NCT00023595|147233035|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
73842444|NCT00023595|147233035|SUPERIORITY|||||||0.84||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.84
73842445|NCT00023595|147233036|SUPERIORITY||||||<|0.0001||||||Hospital costs|Wilcoxon (Mann-Whitney)|||||||<0.0001
73842446|NCT00023595|147233036|SUPERIORITY||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)|||||||<0.0001
73842447|NCT00023595|147233036|SUPERIORITY||||||<|0.0001||||||Total index cost|Wilcoxon (Mann-Whitney)|||||||<0.0001
73842448|NCT00023595|147233037|SUPERIORITY|||||||0.006||||||Hospital costs|Wilcoxon (Mann-Whitney)|||||||0.006
73842449|NCT00023595|147233037|SUPERIORITY||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)|||||||<0.0001
73842450|NCT00023595|147233037|SUPERIORITY|||||||0.004||||||Total index cost|Wilcoxon (Mann-Whitney)|||||||0.004
73842451|NCT03900650|147233038|OTHER||Mean Difference (Final Values)|7.32|||<|0.01|TWO_SIDED||||||ANOVA|||||||<.01
73842452|NCT03900650|147233039|OTHER||Mean Difference (Final Values)|0.377||||0.77|TWO_SIDED|||||This p-value tests the effect of the study arms on number of sex events.|ANOVA|||||||.770
73842453|NCT00086515|147233040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|||<|0.001|TWO_SIDED|95.0|-0.77|-0.53|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline A1C||||-0.53|-0.77|<0.001
73842454|NCT00086515|147233041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4|||<|0.001|TWO_SIDED|95.0|-31.0|-19.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline FPG||||-19.8|-31.0|<0.001
73842455|NCT00086515|147233042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.6|||<|0.001|TWO_SIDED|95.0|-60.5|-40.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline 2-hour PMG||||-40.8|-60.5|<0.001
73842456|NCT02106832|147233043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7062||||0.0511|TWO_SIDED|99.9|0.3928|1.2698|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 99.9% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.2698|0.3928|0.0511
73842457|NCT02106832|147233051|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8662||||0.3965|TWO_SIDED|95.1|0.6206|1.209|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 95.1% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.2090|0.6206|0.3965
73842458|NCT00265122|147233052|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||The P-Value is from a Cochran-Mantel-Haenszel (CMH) test stratified by the route of administration.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference between ustekinumab and placebo at a significant level of 0.05.||||0.337
73842459|NCT00265122|147233054|SUPERIORITY_OR_OTHER|||||||0.292||95.0||||The P-Value is from a CMH test stratified by the route of administration.|Cochran-Mantel-Haenszel|||||||0.292
73842460|NCT00608062|147233056|OTHER|Repeated measurements of FMD were modeled using a general linear mixed model with maximum likelihood estimation. An unstructured covariance structure allowing for heterogeneity in the parameter estimate for each level of menopause stage was chosen for the model based on using AIC to compare various covariance structures.||||||0.05|||||||Mixed Models Analysis|||||||0.05
73842461|NCT00608062|147233058|OTHER|Similar analyses as primary outcome||||||0.05|||||||Mixed Models Analysis|||||||0.05
73842462|NCT00608062|147233059|OTHER|same analysis as primary outcome||||||0.05|||||||Mixed Models Analysis|||||||0.05
73842463|NCT04992065|147233065|SUPERIORITY||Treatment difference|-31.95|||<|0.0001|TWO_SIDED|95.0|-43.02|-20.87|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-20.87|-43.02|<.0001
73842464|NCT04992065|147233065|SUPERIORITY||Treatment difference|-44.91|||<|0.0001|TWO_SIDED|95.0|-56.04|-33.79|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-33.79|-56.04|<.0001
73842465|NCT04992065|147233065|SUPERIORITY||Treatment difference|-61.83|||<|0.0001|TWO_SIDED|95.0|-72.94|-50.72|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-50.72|-72.94|<.0001
73842466|NCT04992065|147233065|SUPERIORITY||Treatment difference|33.32|||||TWO_SIDED|95.0|22.16|44.47||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||44.47|22.16|
73842467|NCT04992065|147233065|SUPERIORITY||Treatment difference|20.35|||||TWO_SIDED|95.0|9.21|31.48||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||31.48|9.21|
73842468|NCT04992065|147233065|SUPERIORITY||Treatment difference|3.43|||||TWO_SIDED|95.0|-7.81|14.68||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||14.68|-7.81|
73842469|NCT00663260|147233082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1448||0.561|TWO_SIDED|95.0|-0.37|0.2||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||0.20|-0.37|0.561
73842470|NCT00663260|147233082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1457||0.435|TWO_SIDED|95.0|-0.4|0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||0.17|-0.40|0.435
73842471|NCT00663260|147233083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|8.142|||TWO_SIDED|95.0|-29.7|2.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||2.4|-29.7|
73842472|NCT00663260|147233083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|8.136|||TWO_SIDED|95.0|-25.0|7.0||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||7.0|-25.0|
73842473|NCT00663260|147233084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.4435|||TWO_SIDED|95.0|-2.68|-0.94||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||-0.94|-2.68|
73842474|NCT00663260|147233084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.4395|||TWO_SIDED|95.0|-3.03|-1.29||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||-1.29|-3.03|
73842475|NCT02231580|147233098|SUPERIORITY_OR_OTHER||GLS mean ratio|1.104|||=|0.5743|TWO_SIDED|90.0|0.823|1.482|||MMRM|||Left hand position-index statistical analysis is presented (BN82451B versus Placebo). The Mixed Effect Model Repeat Measurement (MMRM) analysis was performed on log-transformed data using the restricted maximum likelihood (REML) model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.482|0.823|=0.5743
73842476|NCT02231580|147233098|SUPERIORITY_OR_OTHER||GLS mean ratio|1.141|||=|0.4349|TWO_SIDED|90.0|0.862|1.51|||MMRM|||Right hand position-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.510|0.862|=0.4349
73842477|NCT02231580|147233099|SUPERIORITY_OR_OTHER||GLS mean ratio|1.035|||=|0.8937|TWO_SIDED|90.0|0.675|1.587|||MMRM|||Left hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.587|0.675|=0.8937
73842478|NCT02231580|147233099|SUPERIORITY_OR_OTHER||GLS mean ratio|1.093|||=|0.636|TWO_SIDED|90.0|0.8|1.493|||MMRM|||Right hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.493|0.800|=0.6360
73842479|NCT02231580|147233100|SUPERIORITY_OR_OTHER||GLS mean ratio|1.247|||=|0.2865|TWO_SIDED|90.0|0.886|1.756|||MMRM|||Left hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.756|0.886|=0.2865
73842480|NCT02231580|147233100|SUPERIORITY_OR_OTHER||GLS mean ratio|1.16|||=|0.5338|TWO_SIDED|90.0|0.781|1.724|||MMRM|||Right hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.724|0.781|=0.5338
73842481|NCT02231580|147233101|SUPERIORITY_OR_OTHER||GLS mean ratio|0.693|||=|0.0864|TWO_SIDED|90.0|0.487|0.985|||MMRM|||Left hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.985|0.487|=0.0864
73842482|NCT02231580|147233101|SUPERIORITY_OR_OTHER||GLS mean ratio|0.686|||=|0.0399|TWO_SIDED|90.0|0.508|0.925|||MMRM|||Right hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.925|0.508|=0.0399
73842483|NCT02231580|147233102|SUPERIORITY_OR_OTHER||GLS mean ratio|1.509|||=|0.0574|TWO_SIDED|90.0|1.06|2.15|||MMRM|||Left finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.150|1.060|=0.0574
74022422|NCT01431287|147597107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.381|STANDARD_ERROR_OF_MEAN|0.582||0.0177|TWO_SIDED|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.240|-2.521|0.0177
74022423|NCT01431287|147597107|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.027|STANDARD_ERROR_OF_MEAN|0.58||0.9624|TWO_SIDED|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.109|-1.164|0.9624
74022424|NCT01431287|147597108|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.595|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.862|0.329|<0.0001
73863215|NCT03344640|147272628|SUPERIORITY||Difference and 90% CI versus placebo|0.765||||0.765|TWO_SIDED|90.0|-6.27|9.03|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 85||9.03|-6.27|0.765
73842484|NCT02231580|147233102|SUPERIORITY_OR_OTHER||GLS mean ratio|0.953|||=|0.8277|TWO_SIDED|90.0|0.662|1.372|||MMRM|||Right finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.372|0.662|=0.8277
73842485|NCT02231580|147233102|SUPERIORITY_OR_OTHER||GLS mean ratio|1.238|||=|0.0162|TWO_SIDED|90.0|1.074|1.426|||MMRM|||Left finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.426|1.074|=0.0162
73842486|NCT02231580|147233102|SUPERIORITY_OR_OTHER||GLS mean ratio|1.038|||=|0.632|TWO_SIDED|90.0|0.912|1.182|||MMRM|||Right finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.182|0.912|=0.6320
73842487|NCT02231580|147233103|SUPERIORITY_OR_OTHER||GLS mean ratio|1.308|||=|0.3005|TWO_SIDED|90.0|0.85|2.014|||MMRM|||Left finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.014|0.85|=0.3005
73842488|NCT02231580|147233103|SUPERIORITY_OR_OTHER||GLS mean ratio|1.177|||=|0.4793|TWO_SIDED|90.0|0.804|1.722|||MMRM|||Right finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.722|0.804|=0.4793
73842489|NCT02231580|147233103|SUPERIORITY_OR_OTHER||GLS mean ratio|1.15|||=|0.2653|TWO_SIDED|90.0|0.934|1.416|||MMRM|||Left finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.416|0.934|=0.2653
73842490|NCT02231580|147233103|SUPERIORITY_OR_OTHER||GLS mean ratio|1.045|||=|0.6777|TWO_SIDED|90.0|0.875|1.248|||MMRM|||Right finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.248|0.875|=0.6777
73842491|NCT02231580|147233104|SUPERIORITY_OR_OTHER||GLS mean ratio|1.618|||=|0.0326|TWO_SIDED|90.0|1.124|2.331|||MMRM|||Left finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.331|1.124|=0.0326
73842492|NCT02231580|147233104|SUPERIORITY_OR_OTHER||GLS mean ratio|0.886|||=|0.6016|TWO_SIDED|90.0|0.605|1.299|||MMRM|||Right finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.299|0.605|=0.6016
73842493|NCT02231580|147233104|SUPERIORITY_OR_OTHER||GLS mean ratio|1.242|||=|0.0152|TWO_SIDED|90.0|1.077|1.433|||MMRM|||Left finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.433|1.077|=0.0152
73842494|NCT02231580|147233104|SUPERIORITY_OR_OTHER||GLS mean ratio|1.042|||=|0.6033|TWO_SIDED|90.0|0.915|1.186|||MMRM|||Right finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.186|0.915|=0.6033
73842495|NCT02231580|147233105|SUPERIORITY_OR_OTHER||GLS mean ratio|1.657|||=|0.052|TWO_SIDED|90.0|1.086|2.529|||MMRM|||Left finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.529|1.086|=0.0520
73842496|NCT02231580|147233105|SUPERIORITY_OR_OTHER||GLS mean ratio|0.916|||=|0.6978|TWO_SIDED|90.0|0.63|1.333|||MMRM|||Right finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.333|0.630|=0.6978
73842497|NCT02231580|147233105|SUPERIORITY_OR_OTHER||GLS mean ratio|1.298|||=|0.0522|TWO_SIDED|90.0|1.043|1.614|||MMRM|||Left finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.614|1.043|=0.0522
73842498|NCT02231580|147233105|SUPERIORITY_OR_OTHER||GLS mean ratio|1.014|||=|0.9012|TWO_SIDED|90.0|0.837|1.229|||MMRM|||Right finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.229|0.837|=0.9012
73842499|NCT02231580|147233106|SUPERIORITY_OR_OTHER||GLS mean ratio|1.198|||=|0.1779|TWO_SIDED|90.0|0.96|1.494|||MMRM|||Left finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.494|0.96|=0.1779
73842500|NCT02231580|147233106|SUPERIORITY_OR_OTHER||GLS mean ratio|0.966|||=|0.8036|TWO_SIDED|90.0|0.765|1.22|||MMRM|||Right finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.220|0.765|=0.8036
73842501|NCT02231580|147233107|SUPERIORITY_OR_OTHER||GLS mean ratio|0.812|||=|0.0177|TWO_SIDED|90.0|0.706|0.935|||MMRM|||Left finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.935|0.706|=0.0177
73842502|NCT02231580|147233107|SUPERIORITY_OR_OTHER||GLS mean ratio|0.967|||=|0.6491|TWO_SIDED|90.0|0.856|1.093|||MMRM|||Right finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.093|0.856|=0.6491
73842503|NCT02231580|147233108|SUPERIORITY_OR_OTHER||GLS mean ratio|1.168|||=|0.6176|TWO_SIDED|90.0|0.697|1.955|||MMRM|||Left hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.955|0.697|=0.6176
73842504|NCT02231580|147233108|SUPERIORITY_OR_OTHER||GLS mean ratio|0.759|||=|0.4541|TWO_SIDED|90.0|0.411|1.399|||MMRM|||Right hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.399|0.411|=0.4541
73842505|NCT02231580|147233108|SUPERIORITY_OR_OTHER||GLS mean ratio|1.119|||=|0.2018|TWO_SIDED|90.0|0.967|1.294|||MMRM|||Left hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.294|0.967|=0.2018
73842506|NCT02231580|147233108|SUPERIORITY_OR_OTHER||GLS mean ratio|1.046|||=|0.6527|TWO_SIDED|90.0|0.886|1.234|||MMRM|||Right hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.234|0.886|=0.6527
73842507|NCT02231580|147233109|SUPERIORITY_OR_OTHER||GLS mean ratio|0.929|||=|0.8279|TWO_SIDED|90.0|0.529|1.63|||MMRM|||Left hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.630|0.529|=0.8279
73842508|NCT02231580|147233109|SUPERIORITY_OR_OTHER||GLS mean ratio|0.612|||=|0.2738|TWO_SIDED|90.0|0.292|1.283|||MMRM|||Right hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.283|0.292|=0.2738
73842509|NCT02231580|147233109|SUPERIORITY_OR_OTHER||GLS mean ratio|1.018|||=|0.9218|TWO_SIDED|90.0|0.752|1.378|||MMRM|||Left hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.378|0.752|=0.9218
73842510|NCT02231580|147233109|SUPERIORITY_OR_OTHER||GLS mean ratio|0.847|||=|0.5032|TWO_SIDED|90.0|0.561|1.277|||MMRM|||Right hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.277|0.561|=0.5032
73842511|NCT02231580|147233110|SUPERIORITY_OR_OTHER||GLS mean ratio|1.14|||=|0.6759|TWO_SIDED|90.0|0.677|1.917|||MMRM|||Left hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.917|0.677|=0.6759
73842512|NCT02231580|147233110|SUPERIORITY_OR_OTHER||GLS mean ratio|0.815|||=|0.5764|TWO_SIDED|90.0|0.444|1.496|||MMRM|||Right hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.496|0.444|=0.5764
73842513|NCT02231580|147233110|SUPERIORITY_OR_OTHER||GLS mean ratio|1.115|||=|0.2127|TWO_SIDED|90.0|0.965|1.289|||MMRM|||Left hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.289|0.965|=0.2127
73842514|NCT02231580|147233110|SUPERIORITY_OR_OTHER||GLS mean ratio|1.059|||=|0.5661|TWO_SIDED|90.0|0.897|1.25|||MMRM|||Right hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.25|0.897|=0.5661
73842515|NCT02231580|147233111|SUPERIORITY_OR_OTHER||GLS mean ratio|1.571|||=|0.0874|TWO_SIDED|90.0|1.018|2.424|||MMRM|||Left hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.424|1.018|=0.0874
73842516|NCT02231580|147233111|SUPERIORITY_OR_OTHER||GLS mean ratio|1.18|||=|0.6431|TWO_SIDED|90.0|0.644|2.162|||MMRM|||Right hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.162|0.644|=0.6431
73842517|NCT02231580|147233111|SUPERIORITY_OR_OTHER||GLS mean ratio|1.193|||=|0.0389|TWO_SIDED|90.0|1.038|1.371|||MMRM|||Left hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.371|1.038|=0.0389
73842518|NCT02231580|147233111|SUPERIORITY_OR_OTHER||GLS mean ratio|1.138|||=|0.1641|TWO_SIDED|90.0|0.976|1.327|||MMRM|||Right hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.327|0.976|=0.1641
73842519|NCT02231580|147233112|SUPERIORITY_OR_OTHER||GLS mean ratio|0.93|||=|0.5668|TWO_SIDED|90.0|0.755|1.147|||MMRM|||Left hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.147|0.755|=0.5668
73842520|NCT02231580|147233112|SUPERIORITY_OR_OTHER||GLS mean ratio|0.978|||=|0.8686|TWO_SIDED|90.0|0.778|1.229|||MMRM|||Right hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.229|0.778|=0.8686
73842521|NCT02231580|147233113|SUPERIORITY_OR_OTHER||GLS mean ratio|0.879|||=|0.1244|TWO_SIDED|90.0|0.765|1.009|||MMRM|||Left hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.009|0.765|=0.1244
73842522|NCT02231580|147233113|SUPERIORITY_OR_OTHER||GLS mean ratio|0.919|||=|0.3535|TWO_SIDED|90.0|0.789|1.069|||MMRM|||Right hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.069|0.789|=0.3535
73842523|NCT02231580|147233114|SUPERIORITY_OR_OTHER||GLS mean ratio|2.163|||=|0.015|TWO_SIDED|90.0|1.295|3.614|||MMRM|||Left foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.614|1.295|=0.015
73842524|NCT02231580|147233114|SUPERIORITY_OR_OTHER||GLS mean ratio|1.274|||=|0.5136|TWO_SIDED|90.0|0.688|2.361|||MMRM|||Right foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.361|0.688|=0.5136
73863216|NCT03344640|147272628|SUPERIORITY||Difference and 90% CI versus placebo|0.491||||0.491|TWO_SIDED|90.0|-4.73|11.45|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 127||11.45|-4.73|0.491
73863217|NCT03344640|147272628|SUPERIORITY||Difference and 90% CI versus placebo|2.44||||0.639|TWO_SIDED|90.0|-6.19|11.07|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at end of study||11.07|-6.19|0.639
73959796|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|10.6||0.5705|ONE_SIDED|95.0|-19.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.5|0.5705
73959797|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|10.3||0.8063|ONE_SIDED|95.0|-26.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-26.1|0.8063
73842525|NCT02231580|147233114|SUPERIORITY_OR_OTHER||GLS mean ratio|1.56|||=|0.0218|TWO_SIDED|90.0|1.139|2.137|||MMRM|||Left foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.137|1.139|=0.0218
73842526|NCT02231580|147233114|SUPERIORITY_OR_OTHER||GLS mean ratio|1.251|||=|0.372|TWO_SIDED|90.0|0.825|1.899|||MMRM|||Right foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.899|0.825|=0.3720
73842527|NCT02231580|147233115|SUPERIORITY_OR_OTHER||GLS mean ratio|1.911|||=|0.915|TWO_SIDED|90.0|1.017|3.592|||MMRM|||Left foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.592|1.017|=0.915
73842528|NCT02231580|147233115|SUPERIORITY_OR_OTHER||GLS mean ratio|1.687|||=|0.2745|TWO_SIDED|90.0|0.762|3.737|||MMRM|||Right foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.737|0.762|=0.2745
73842529|NCT02231580|147233115|SUPERIORITY_OR_OTHER||GLS mean ratio|1.598|||=|0.1148|TWO_SIDED|90.0|0.98|2.608|||MMRM|||Left foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.608|0.980|=0.1148
73842530|NCT02231580|147233115|SUPERIORITY_OR_OTHER||GLS mean ratio|1.454|||=|0.308|TWO_SIDED|90.0|0.789|2.679|||MMRM|||Right foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.679|0.789|=0.3080
73842531|NCT02231580|147233116|SUPERIORITY_OR_OTHER||GLS mean ratio|2.272|||=|0.0079|TWO_SIDED|90.0|1.381|3.737|||MMRM|||Left foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.737|1.381|=0.0079
73842532|NCT02231580|147233116|SUPERIORITY_OR_OTHER||GLS mean ratio|1.21|||=|0.0204|TWO_SIDED|90.0|0.686|2.133|||MMRM|||Right foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.133|0.686|=0.0204
73842533|NCT02231580|147233116|SUPERIORITY_OR_OTHER||GLS mean ratio|1.564|||=|0.0204|TWO_SIDED|90.0|1.144|2.138|||MMRM|||Left foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.138|1.144|=0.0204
73842534|NCT02231580|147233116|SUPERIORITY_OR_OTHER||GLS mean ratio|1.269|||=|0.3144|TWO_SIDED|90.0|0.856|1.884|||MMRM|||Right foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.884|0.856|=0.3144
74084268|NCT01525628|147721694|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|97.03|STANDARD_DEVIATION|30.8||0.05|TWO_SIDED|90.0|80.0|117.69|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||117.69|80.00|0.0500
73842535|NCT02231580|147233117|SUPERIORITY_OR_OTHER||GLS mean ratio|1.914|||=|0.0324|TWO_SIDED|90.0|1.167|3.141|||MMRM|||Left foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.141|1.167|=0.0324
73863218|NCT03344640|147272629|SUPERIORITY||Difference and 90% CI versus Placebo|1.23||||0.735|TWO_SIDED|90.0|-4.81|7.28||Difference and 90% CI versus placebo|LS Mean|LS mean change from baseline in QuickDASH total score||Statistical analysis results of QuickDASH total score (PD Analysis Set) at day 99||7.28|-4.81|0.735
73959798|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|9.1||0.6667|ONE_SIDED|95.0|-19.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.1|0.6667
73959799|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|10.4||0.464|ONE_SIDED|95.0|-16.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-16.4|0.4640
73842536|NCT02231580|147233117|SUPERIORITY_OR_OTHER||GLS mean ratio|1.462|||=|0.246|TWO_SIDED|90.0|0.85|2.515|||MMRM|||Right foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.515|0.85|=0.246
73842537|NCT02231580|147233117|SUPERIORITY_OR_OTHER||GLS mean ratio|1.387|||=|0.1057|TWO_SIDED|90.0|0.994|1.935|||MMRM|||Left foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.935|0.994|=0.1057
73842538|NCT02231580|147233117|SUPERIORITY_OR_OTHER||GLS mean ratio|1.074|||=|0.7342|TWO_SIDED|90.0|0.758|1.523|||MMRM|||Right foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.523|0.758|=0.7342
73842539|NCT02231580|147233118|SUPERIORITY_OR_OTHER||GLS mean ratio|1.392|||=|0.1027|TWO_SIDED|90.0|0.997|1.943|||MMRM|||Left foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.943|0.997|=0.1027
73842540|NCT02231580|147233118|SUPERIORITY_OR_OTHER||GLS mean ratio|1.158|||=|0.4494|TWO_SIDED|90.0|0.84|1.595|||MMRM|||Right foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.595|0.840|=0.4494
73842541|NCT02231580|147233119|SUPERIORITY_OR_OTHER||GLS mean ratio|0.699|||=|0.035|TWO_SIDED|90.0|0.53|0.922|||MMRM|||Left foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.922|0.530|=0.0350
73842542|NCT02231580|147233119|SUPERIORITY_OR_OTHER||GLS mean ratio|0.853|||=|0.3556|TWO_SIDED|90.0|0.64|1.136|||MMRM|||Right foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.136|0.640|=0.3556
73842543|NCT03620981|147233120|SUPERIORITY||LS Mean Difference (Final Values)|-7.2|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.3|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-4.3|-10.0|< 0.0001
73842544|NCT03620981|147233120|SUPERIORITY||LS Mean Difference (Final Values)|-3.7||||0.0175|TWO_SIDED|95.0|-6.8|-0.7|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.7|-6.8|0.0175
73842545|NCT03620981|147233121|SUPERIORITY||LS Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-0.5|-1.0|< 0.0001
73842546|NCT03620981|147233121|SUPERIORITY||LS Mean Difference (Final Values)|-0.3||||0.0083|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.1|-0.6|0.0083
73842547|NCT03620981|147233122|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH), Last observation carried forward (LOCF)||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-0.6|-1.2|< 0.0001
74022425|NCT01431287|147597108|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.907|0.373|<0.0001
74022426|NCT01431287|147597108|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.423|STANDARD_ERROR_OF_MEAN|0.136||0.0019|TWO_SIDED|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.690|0.156|0.0019
73842548|NCT03620981|147233122|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.0052|TWO_SIDED|95.0|-0.8|-0.1|||Cochran-Mantel-Haenszel|CMH, LOCF||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.1|-0.8|0.0052
73842549|NCT05081843|147233156|SUPERIORITY||Mean Difference (Final Values)|0.233||||0.05|TWO_SIDED|95.0|-0.056|0.522|||t-test, 2 sided|||||0.522|-0.056|0.05
73842550|NCT05081843|147233157|SUPERIORITY||Median Difference (Final Values)|0.534||||0.05|TWO_SIDED|95.0|0.078|0.99|||t-test, 2 sided|||||0.990|0.078|0.05
73842551|NCT05081843|147233158|SUPERIORITY||Mean Difference (Final Values)|0.326||||0.05|TWO_SIDED|95.0|-0.177|0.829|||t-test, 2 sided|||||0.829|-0.177|0.05
73842552|NCT05081843|147233159|SUPERIORITY||Mean Difference (Final Values)|0.756||||0.05|TWO_SIDED|95.0|0.208|1.31|||t-test, 2 sided|||||1.31|0.208|0.05
73863219|NCT03344640|147272629|SUPERIORITY||Difference and 90% CI versus Placebo|1.51||||0.689|TWO_SIDED|90.0|-4.76|7.79|||LS Mean|LS mean change from baseline in QuickDASH total score||Statistical analysis results of QuickDASH total score (PD analysis set) at End of Study||7.79|-4.76|0.689
73842553|NCT02303821|147233166|OTHER||||||||||||||||||The objective of this endpoint was to compare the rate of CRi or better status against an external control arm selected from an observational study (Amgen 20180065). The rate of CRi or better status in the external control arm was 26.3% (95% CI: 15.1, 37.5) for B-Cell participants with treatment difference odds ratio of 2.082 (95% CI: 0.968, 4.477). For T-Cell participants the rate of CRi or better status was 18.6% (95% CI: 7.1, 30.0) with treatment difference odds ratio of 1.646 (95% CI: 0.639. 4.245).|||
73842554|NCT02303821|147233167|OTHER||||||||||||||||||The objective of this endpoint was to compare EFS in study 20140106 with EFS in an external control arm selected from an observational study (Amgen 20180065). The median duration in months in the external control arm was 3.62 (95% CI: 1.55, 5.36) for B-cell participants, with a treatment difference hazard ration of 1.435 (95% CI: 0.976, 2.111). For T-Cell participants the median in months was 2.93 (95% CI: 0.95, 5.10) with a treatment difference hazard ratio of 1.404 (95% CI: 0.869, 2.270).|||
73842555|NCT02303821|147233168|OTHER||||||||||||||||||The objective of this endpoint was to compare the OS in study 20140106 with OS in an external control arm selected from an observational study (Amgen 20180065). The median OS in months for the B-Cell participants in the external control arm was 8.59 (95% CI: 5.26, 10.59) with a treatment difference hazard ratio of 1.245 (95% CI: 0.805, 1.927). For the T-Cell participants the median OS in months was 7.04 (95% CI: 7.04, NE) with a treatment difference hazard ratio of 1.040 (95% CI: 0.641, 1.688).|||
73842556|NCT02303821|147233169|OTHER||||||||||||||||||The DOR in study 20140106 was estimated relative to the DOR in an external control arm selected from an observational study (Amgen 20180065). The median DOR in months in the external control arm was 8.72 (95% CI: 5.07, 32.24) in B-Cell participants. For T-Cell participants the median DOR in months was 5.82 (95% CI: 1.22, 19.80).|||
73842557|NCT02303821|147233181|OTHER||||||||||||||||||The primary objective of this endpoint was to compare the percentage of participants achieving CR after the end of induction therapy in study 20140106 with the percentage of participants achieving CR in an external control arm selected from an observational study (Amgen 20180065). In the external control arm, 7.8% of B-Cell participants (95% confidence interval \[CI\]: 1.0%, 14.7%) achieved CR, with a treatment difference odds ratio of 2.04 (95% CI: 0.54, 7.66). For T-Cell participants, 9.1% (95% CI: 0.7%, 17.5%) achieved CR, with an odds ratio of 1.58 (95% CI: 0.47, 5.31).|||
73842558|NCT04938427|147233183|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-1.17|||=|0.785|TWO_SIDED|95.0|-13.02|9.99||The p-value was calculated using Rank Analysis of Covariance (ANCOVA) model using treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% confidence interval (CI) are based on the Hodges-Lehmann estimation.|||9.99|-13.02|=0.785
73842559|NCT04938427|147233184|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|2.43|||=|0.778|TWO_SIDED|95.0|-10.86|15.14||The p-value was calculated using the Rank ANCOVA model using the treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||15.14|-10.86|=0.778
73842560|NCT04938427|147233185|SUPERIORITY||Odds Ratio (OR)|1.91|||||TWO_SIDED|95.0|0.94|3.87||||||||3.87|0.94|
73842561|NCT04938427|147233186|SUPERIORITY||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.92|4.05||||||||4.05|0.92|
73842562|NCT04938427|147233188|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|0.86|2.13||||||||2.13|0.86|
73842563|NCT04938427|147233189|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.89|2.21||||||||2.21|0.89|
73842564|NCT04938427|147233190|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.85|2.3||||||Alertness Domain||2.30|0.85|
74022427|NCT01431287|147597108|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.446|STANDARD_ERROR_OF_MEAN|0.136||0.0011|TWO_SIDED|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.712|0.179|0.0011
74084269|NCT01525628|147721694|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|97.1|STANDARD_DEVIATION|31.2||0.0564|TWO_SIDED|90.0|79.37|118.79|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||118.79|79.37|0.0564
73842565|NCT04938427|147233190|SUPERIORITY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.91|2.48||||||Communication Domain||2.48|0.91|
73842566|NCT04938427|147233190|SUPERIORITY||Odds Ratio (OR)|1.91|||||TWO_SIDED|95.0|1.06|3.43||||||Disruptive Behaviors Domain||3.43|1.06|
73842567|NCT04938427|147233191|SUPERIORITY||Least Square Mean Difference|0.52|||||TWO_SIDED|95.0|-2.2|3.24||||||||3.24|-2.20|
73842568|NCT04938427|147233192|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|1.06|2.65||||||||2.65|1.06|
73842569|NCT04938427|147233193|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-6.37|||||TWO_SIDED|95.0|-16.83|4.16|||||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||4.16|-16.83|
73842570|NCT04938427|147233194|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-6.65|||||TWO_SIDED|95.0|-16.67|3.12|||||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||3.12|-16.67|
73842571|NCT04938427|147233195|SUPERIORITY||LS Mean Difference|2.47|||||TWO_SIDED|95.0|-1.74|6.67|||||A linear model with treatment group and age stratum as factors and baseline percentage as a covariate was used for analysis.|||6.67|-1.74|
73842572|NCT04938427|147233196|SUPERIORITY||LS Mean Difference|5.4|||||TWO_SIDED|95.0|1.9|8.9||||||||8.9|1.9|
73842573|NCT04938427|147233197|SUPERIORITY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-3.7|2.0||||||||2.0|-3.7|
73842574|NCT05852340|147233202|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|102.36|||||TWO_SIDED|90.0|95.81|109.35||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Strawberry Jam (Fasted)||109.35|95.81|
73842575|NCT05852340|147233202|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|97.15|||||TWO_SIDED|90.0|90.94|103.79||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Yoghurt (Fasted)||103.79|90.94|
73842576|NCT05852340|147233202|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|99.65|||||TWO_SIDED|90.0|93.28|106.46||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Applesauce (Fasted)||106.46|93.28|
73842577|NCT05852340|147233202|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|104.84|||||TWO_SIDED|90.0|97.3|112.96||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Given with High Fat Meal||112.96|97.30|
73842578|NCT05852340|147233203|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|96.63|||||TWO_SIDED|90.0|83.66|111.62||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Strawberry Jam (Fasted)||111.62|83.66|
73842579|NCT05852340|147233203|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|84.58|||||TWO_SIDED|90.0|73.23|97.7||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Yoghurt (Fasted)||97.70|73.23|
73842580|NCT05852340|147233203|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|93.91|||||TWO_SIDED|90.0|81.3|108.48||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Applesauce (Fasted)||108.48|81.30|
73842581|NCT05852340|147233203|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|43.83|||||TWO_SIDED|90.0|37.5|51.23||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Given with High Fat Meal||51.23|37.50|
73842582|NCT05852470|147233206|NON_INFERIORITY|Non-inferiority margin = 0.1 logMAR|Difference in Means|0.034|STANDARD_ERROR_OF_MEAN|0.0167|||TWO_SIDED|95.0|0.001|0.067||Since a non-inferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the non-inferiority margin.|||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|||0.067|0.001|
73842583|NCT05852470|147233207|SUPERIORITY||Difference in Means|-0.091|STANDARD_ERROR_OF_MEAN|0.0151|<|0.001|TWO_SIDED|95.0|-0.12|-0.061|||t-test, 1 sided||||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|-0.061|-0.120|<.001
73842584|NCT05852470|147233208|SUPERIORITY||Difference in Means|-0.129|STANDARD_ERROR_OF_MEAN|0.0202|<|0.001|TWO_SIDED|95.0|-0.169|-0.089|||t-test, 1 sided||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|||-0.089|-0.169|<.001
73842585|NCT05852470|147233209|SUPERIORITY||Difference in Percentages|17.32|||||TWO_SIDED|90.0|8.66||Upper limit is not applicable for testing.|The lower boundary of the confidence interval is reported instead of a p-value.|Miettinen-Nurminen||Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL||||8.66|
73898525|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|1.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73842586|NCT01346592|147233216|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H1N1 strain)|2.44|||||TWO_SIDED|97.6|2.06|2.9||||||||2.9|2.06|
73842587|NCT01346592|147233216|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H3N2 strain)|1.89|||||TWO_SIDED|97.6|1.69|2.1||||||||2.1|1.69|
73959800|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|10.2||0.8821|ONE_SIDED|95.0|-29.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-29.3|0.8821
73842588|NCT01346592|147233216|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (B strain)|3.07|||||TWO_SIDED|97.6|2.66|3.54||||||||3.54|2.66|
73842589|NCT01346592|147233216|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H1N1 strain)|3.2|||||TWO_SIDED|97.6|2.7|3.8||||||||3.8|2.7|
73842590|NCT01346592|147233216|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H3N2 strain)|2.38|||||TWO_SIDED|97.6|2.14|2.65||||||||2.65|2.14|
73842591|NCT01346592|147233216|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (B strain)|3.14|||||TWO_SIDED|97.6|2.72|3.62||||||||3.62|2.72|
73842592|NCT01346592|147233217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \>-10%.|Group difference (H1N1 strain)|9.09|||||TWO_SIDED|97.6|5.48|12.69||||||||12.69|5.48|
73898526|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.116||0.014|TWO_SIDED|95.0|-0.514|-0.059||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.059|-0.514|0.014
73842593|NCT01346592|147233217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \>-10%|Group difference (H3N2 strain)|4.07|||||TWO_SIDED|97.6|1.58|6.55||||||||6.55|1.58|
73842594|NCT01346592|147233217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (B strain)|11.82|||||TWO_SIDED|97.6|8.72|14.92||||||||14.92|8.72|
73842595|NCT01346592|147233217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H1N1 strain)|14.21|||||TWO_SIDED|97.6|10.3|18.13||||||||18.13|10.3|
73842596|NCT01346592|147233217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H3N2 strain)|7.31|||||TWO_SIDED|97.6|4.47|10.14||||||||10.14|4.47|
73842597|NCT01346592|147233217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (B strain)|11.1|||||TWO_SIDED|97.6|8.11|14.1||||||||14.1|8.11|
73842598|NCT01346592|147233218|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|Group ratio (H1N1 strain)|0.76|||||TWO_SIDED|97.4|0.62|0.93||||||||0.93|0.62|
73842599|NCT01346592|147233218|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|GMT ratio (H3N2 strain)|0.77|||||TWO_SIDED|97.4|0.68|0.86||||||||0.86|0.68|
73842600|NCT01346592|147233218|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|GMT ratio (B strain)|0.94|||||TWO_SIDED|97.4|0.8|1.11||||||||1.11|0.8|
73842601|NCT01346592|147233219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (H1N1 strain)|-5.3|||||TWO_SIDED|97.4|-10.13|-0.47||||||||-0.47|-10.13|
73842602|NCT01346592|147233219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (H3N2 strain)|-2.84|||||TWO_SIDED|97.4|-6.16|0.5||||||||0.5|-6.16|
73842603|NCT01346592|147233219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (B strain)|-2.49|||||TWO_SIDED|97.4|-7.01|2.0||||||||2|-7.01|
73842604|NCT01346592|147233220|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|3.63|||||TWO_SIDED|95.0|2.86|4.6||||||Superiority was concluded if the lower limit of the confidence interval for the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||4.6|2.86|
73959801|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|9.0||0.7591|ONE_SIDED|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.4|0.7591
74084270|NCT01525628|147721694|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|114.38|STANDARD_DEVIATION|31.9||0.2375|TWO_SIDED|90.0|92.36|141.66|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||141.66|92.36|0.2375
73842605|NCT01346592|147233220|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|2.25|||||TWO_SIDED|95.0|1.96|2.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.59|1.96|
73842606|NCT01346592|147233220|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|4.64|||||TWO_SIDED|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||5.59|3.86|
73842607|NCT01346592|147233220|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|5.28|||||TWO_SIDED|95.0|4.16|6.7||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||6.7|4.16|
73842608|NCT01346592|147233220|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|3.1|||||TWO_SIDED|95.0|2.69|3.56||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.56|2.69|
73959802|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|11.0||0.4001|ONE_SIDED|95.0|-15.6||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.6|0.4001
73842609|NCT01346592|147233220|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|4.64|||||TWO_SIDED|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||5.59|3.86|
73842610|NCT01346592|147233221|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|10.4|||||TWO_SIDED|95.0|6.1|14.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||14.7|6.1|
73842611|NCT01346592|147233221|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|2.5|||||TWO_SIDED|95.0|-0.12|5.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||5.1|-0.12|
73842612|NCT01346592|147233221|SUPERIORITY_OR_OTHER||Group difference (B strain)|12.8|||||TWO_SIDED|95.0|8.9|16.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||16.7|8.9|
73842613|NCT01346592|147233221|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|17.7|||||TWO_SIDED|95.0|12.9|22.6||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||22.6|12.9|
73842614|NCT01346592|147233221|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|5.6|||||TWO_SIDED|95.0|2.5|8.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||8.7|2.5|
73842615|NCT01346592|147233221|SUPERIORITY_OR_OTHER||Group difference (B strain)|18.8|||||TWO_SIDED|95.0|14.4|23.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||23.1|14.4|
73842616|NCT01346592|147233222|SUPERIORITY_OR_OTHER||GMT Ratio (H1N1 strain)|2.38|||||TWO_SIDED|95.0|2.07|2.75||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.75|2.07|
73842617|NCT01346592|147233222|SUPERIORITY_OR_OTHER||GMT Ratio (H3N2 strain)|1.88|||||TWO_SIDED|95.0|1.72|2.06||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.06|1.72|
73842618|NCT01346592|147233222|SUPERIORITY_OR_OTHER||GMT Ratio (B strain)|2.93|||||TWO_SIDED|95.0|2.6|3.3||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.3|2.6|
73842619|NCT01346592|147233222|SUPERIORITY_OR_OTHER||GMT Ratio (H1N1 strain)|3.21|||||TWO_SIDED|95.0|2.79|3.71||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.71|2.79|
73842620|NCT01346592|147233222|SUPERIORITY_OR_OTHER||GMT Ratio (H3N2 strain)|2.4|||||TWO_SIDED|95.0|2.19|2.62||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.62|2.19|
73842621|NCT01346592|147233222|SUPERIORITY_OR_OTHER||GMT Ratio (B strain)|3.08|||||TWO_SIDED|95.0|2.73|3.47||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.47|2.73|
73842622|NCT01346592|147233223|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|9.3|||||TWO_SIDED|95.0|6.3|12.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||12.4|6.3|
73842623|NCT01346592|147233223|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|3.9|||||TWO_SIDED|95.0|1.8|5.9||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||5.9|1.8|
73842624|NCT01346592|147233223|SUPERIORITY_OR_OTHER||Group difference (B strain)|10.7|||||TWO_SIDED|95.0|8.1|13.3||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||13.3|8.1|
73842625|NCT01346592|147233223|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|14.4|||||TWO_SIDED|95.0|11.1|17.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||17.7|11.1|
74084271|NCT01525628|147721694|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|139.07|STANDARD_DEVIATION|22.8||0.9082|TWO_SIDED|90.0|121.63|159.0|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||159.00|121.63|0.9082
73842626|NCT01346592|147233223|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|6.8|||||TWO_SIDED|95.0|4.5|9.1||||||superiority was concluded if the lower bound of 95% CI of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||9.1|4.5|
73842627|NCT01346592|147233223|SUPERIORITY_OR_OTHER||Group difference (B strain)|10.9|||||TWO_SIDED|95.0|8.3|13.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||13.4|8.3|
73842628|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.68|||||TWO_SIDED|95.0|2.3|3.12||||||No risk subjects.||3.12|2.3|
73842629|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.87|||||TWO_SIDED|95.0|1.7|2.05||||||No risk subjects.||2.05|1.7|
73842630|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.04|||||TWO_SIDED|95.0|2.68|3.44||||||No risk subjects.||3.44|2.68|
73842631|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.21|||||TWO_SIDED|95.0|1.11|4.42||||||At risk subjects.||4.42|1.11|
73842632|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.45|||||TWO_SIDED|95.0|1.61|3.72||||||At risk subjects.||3.72|1.61|
73842633|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.46|||||TWO_SIDED|95.0|1.88|6.34||||||At risk subjects||6.34|1.88|
73842634|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratios (H1N1 strain)|3.52|||||TWO_SIDED|95.0|3.03|4.1||||||No risk subjects.||4.1|3.03|
73842635|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.36|||||TWO_SIDED|95.0|2.15|2.59||||||No risk subjects.||2.59|2.15|
73842636|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.14|||||TWO_SIDED|95.0|2.78|3.56||||||No risk subjects.||3.56|2.78|
73842637|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.7|||||TWO_SIDED|95.0|1.28|5.68||||||At risk subjects.||5.68|1.28|
73842638|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.25|||||TWO_SIDED|95.0|2.09|5.06||||||At risk subjects.||5.06|2.09|
73842639|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.76|||||TWO_SIDED|95.0|1.44|5.3||||||At risk subjects.||5.3|1.44|
73842640|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.81|||||TWO_SIDED|95.0|2.34|3.37||||||No risk subjects.||3.37|2.34|
73842641|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.04|||||TWO_SIDED|95.0|1.83|2.28||||||No risk subjects.||2.28|1.83|
73842642|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.74|||||TWO_SIDED|95.0|3.22|4.34||||||No risk subjects||4.34|3.22|
73842643|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.34|||||TWO_SIDED|95.0|0.92|6.0||||||At risk subjects.||6|0.92|
73842644|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.93|||||TWO_SIDED|95.0|1.57|5.45||||||At risk subjects.||5.45|1.57|
73842645|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.55|||||TWO_SIDED|95.0|2.52|12.0||||||At risk subjects||12|2.52|
73842646|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.66|||||TWO_SIDED|95.0|3.05|4.39||||||No risk subjects.||4.39|3.05|
73842647|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.68|||||TWO_SIDED|95.0|2.4|2.99||||||No risk subjects||2.99|2.4|
73842648|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.97|||||TWO_SIDED|95.0|3.42|4.61||||||No risk subjects.||4.61|3.42|
73842649|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.72|||||TWO_SIDED|95.0|1.02|7.31||||||At risk subjects.||7.31|1.02|
73842650|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.5|||||TWO_SIDED|95.0|1.85|6.62||||||At risk subjects.||6.62|1.85|
73959803|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|10.8||0.8707|ONE_SIDED|95.0|-30.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-30.3|0.8707
73959804|NCT00430300|147454781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|9.6||0.4629|ONE_SIDED|95.0|-15.0||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.0|0.4629
73842651|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.26|||||TWO_SIDED|95.0|2.32|12.0||||||At risk subjects.||12|2.32|
73842652|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.55|||||TWO_SIDED|95.0|1.21|1.97||||||No risk subjects.||1.97|1.21|
73842653|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.51|||||TWO_SIDED|95.0|1.26|1.82||||||No risk subjects||1.82|1.26|
73842654|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.9|||||TWO_SIDED|95.0|1.52|2.38||||||No risk subjects||2.38|1.52|
73842655|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.76|||||TWO_SIDED|95.0|0.57|5.4||||||At risk subjects||5.4|0.57|
73842656|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.78|||||TWO_SIDED|95.0|1.09|2.89||||||At risk subjects||2.89|1.09|
73842657|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.82|||||TWO_SIDED|95.0|0.73|4.54||||||At risk subjects||4.54|0.73|
73842658|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.4|||||TWO_SIDED|95.0|1.89|3.05||||||No risk subjects||3.05|1.89|
73842659|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.54|||||TWO_SIDED|95.0|1.29|1.85||||||No risk subjects.||1.85|1.29|
73842660|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.7|||||TWO_SIDED|95.0|1.36|2.11||||||No risk subjects||2.11|1.36|
73842661|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.12|||||TWO_SIDED|95.0|0.58|7.71||||||At risk subjects.||7.71|0.58|
73842662|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.81|||||TWO_SIDED|95.0|1.61|4.89||||||At risk subjects||4.89|1.61|
73842663|NCT01346592|147233228|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.17|||||TWO_SIDED|95.0|0.37|3.67||||||At risk subjects||3.67|0.37|
73842664|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H1N1 strain)|9.0|||||TWO_SIDED|95.0|5.4|12.0||||||No risk subjects.||12|5.4|
73842665|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|1.8|6.6||||||No risk subjects.||6.6|1.8|
73842666|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|9.2|14.8||||||No risk subjects.||14.8|9.2|
73842667|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-1.0|||||TWO_SIDED|95.0|-24.0|18.7||||||At risk subjects.||18.7|-24|
73842668|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|1.0|||||TWO_SIDED|95.0|-21.2|18.9||||||At risk subjects.||18.9|-21.2|
73842669|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|14.0|||||TWO_SIDED|95.0|-1.6|29.5||||||At risk subjects.||29.5|-1.6|
73842670|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|14.0|||||TWO_SIDED|95.0|10.7|17.7||||||No risk subjects.||17.7|10.7|
73842671|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.6|9.8||||||No risk subjects.||9.8|4.6|
73842672|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|10.7|16.4||||||No risk subjects||16.4|10.7|
73842673|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-3.0|||||TWO_SIDED|95.0|-26.1|19.2||||||At risk subjects.||19.2|-26.1|
73842674|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|6.0|||||TWO_SIDED|95.0|-17.5|27.3||||||At risk subjects.||27.3|-17.5|
73842675|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|-4.4|29.2||||||At risk subjects.||29.2|-4.4|
73842676|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|11.0|||||TWO_SIDED|95.0|7.2|14.5||||||No risk subjects.||14.5|7.2|
73842677|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|2.6|7.5||||||No risk subjects.||7.5|2.6|
73842678|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|9.5|15.8||||||No risk subjects.||15.8|9.5|
73842679|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|5.0|||||TWO_SIDED|95.0|-24.7|26.3||||||At risk subjects.||26.3|-24.7|
73842680|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|-26.9|30.3||||||At risk subjects.||30.3|-26.9|
73842681|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|9.0|||||TWO_SIDED|95.0|-16.9|27.1||||||At risk subjects.||27.1|-16.9|
73842682|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|16.0|||||TWO_SIDED|95.0|12.4|20.2||||||No risk subjects.||20.2|12.4|
73842683|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|5.1|10.5||||||No risk subjects||10.5|5.1|
73842684|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|15.0|||||TWO_SIDED|95.0|12.0|18.6||||||No risk subjects||18.6|12|
73842685|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-27.1|25.5||||||At risk subjects||25.5|-27.1|
73842686|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|10.0|||||TWO_SIDED|95.0|-23.5|37.2||||||At risk subjects||37.2|-23.5|
73842687|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|16.0|||||TWO_SIDED|95.0|-10.7|38.0||||||At risk subjects.||38|-10.7|
73842688|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-4.2|10.4||||||No risk subjects.||10.4|-4.2|
73842689|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 subjects)|4.0|||||TWO_SIDED|95.0|-1.2|11.9||||||No risk subjects.||11.9|-1.2|
73842690|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|8.0|||||TWO_SIDED|95.0|2.9|15.1||||||No risk subjects.||15.1|2.9|
73842691|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-5.0|||||TWO_SIDED|95.0|-42.4|32.0||||||At risk subjects.||32|-42.4|
73842692|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-10.0|||||TWO_SIDED|95.0|-41.2|16.6||||||At risk subjects.||16.6|-41.2|
73842693|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|25.0|||||TWO_SIDED|95.0|-7.1|53.9||||||At risk subjects.||53.9|-7.1|
73842694|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|8.0|||||TWO_SIDED|95.0|1.0|16.4||||||No risk subjects.||16.4|1|
73842695|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|2.0|16.1||||||No risk subjects.||16.1|2|
73842696|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|4.0|||||TWO_SIDED|95.0|0.0|10.0||||||No risk subjects.||10|0|
74022428|NCT01431287|147597108|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.468|STANDARD_ERROR_OF_MEAN|0.136||0.0006|TWO_SIDED|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.735|0.201|0.0006
74022429|NCT01431287|147597108|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.172|STANDARD_ERROR_OF_MEAN|0.136||0.2045|TWO_SIDED|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.438|-0.094|0.2045
73842697|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-1.0|||||TWO_SIDED|95.0|-42.1|43.0||||||At risk subjects.||43|-42.1|
73842698|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-10.0|||||TWO_SIDED|95.0|-41.5|28.7||||||At risk subjects||28.7|-41.5|
73842699|NCT01346592|147233229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|0.0|||||TWO_SIDED|95.0|-29.0|36.8||||||At risk subjects.||36.8|-29|
73842700|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|10.0|||||TWO_SIDED|95.0|6.4|12.8||||||No risk subjects.||12.8|6.4|
73842701|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|1.8|6.4||||||No risk subjects.||6.4|1.8|
73842702|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|11.0|||||TWO_SIDED|95.0|8.6|13.9||||||No risk subjects.||13.9|8.6|
73842703|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-4.0|||||TWO_SIDED|95.0|-24.7|14.9||||||At risk subjects.||14.9|-24.7|
73842704|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|-14.4|20.7||||||At risk subjects.||20.7|-14.4|
73842705|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|9.0|||||TWO_SIDED|95.0|-6.8|23.4||||||At risk subjects.||23.4|-6.8|
73842706|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|15.0|||||TWO_SIDED|95.0|11.3|18.1||||||No risk subjects.||18.1|11.3|
73842707|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.2|9.1||||||No risk subjects.||9.1|4.2|
74022430|NCT01431287|147597108|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.618|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.885|0.351|<0.0001
74084272|NCT01525628|147721694|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|122.37|STANDARD_DEVIATION|29.3||0.4111|TWO_SIDED|90.0|104.11|143.84|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||143.84|104.11|0.4111
73842708|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|10.5|16.1||||||No risk subjects.||16.1|10.5|
73842709|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-4.0|||||TWO_SIDED|95.0|-25.3|15.4||||||At risk subjects||15.4|-25.3|
73842710|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|6.0|||||TWO_SIDED|95.0|-12.7|24.2||||||At risk subjects.||24.2|-12.7|
73842711|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group differences (B strain)|8.0|||||TWO_SIDED|95.0|-7.8|23.2||||||At risk subjects.||23.2|-7.8|
73842712|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|12.0|||||TWO_SIDED|95.0|8.2|15.3||||||No risk subjects.||15.3|8.2|
73842713|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|2.5|7.4||||||No risk subjects.||7.4|2.5|
73842714|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|9.2|15.3||||||No risk subjects.||15.3|9.2|
73842715|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-2.0|||||TWO_SIDED|95.0|-28.5|20.2||||||At risk subjects.||20.2|-28.5|
73842716|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|11.0|||||TWO_SIDED|95.0|-14.9|33.5||||||At risk subjects.||33.5|-14.9|
73959805|NCT00430300|147454782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6428|||||TWO_SIDED|95.0|0.2023|2.0419||||||A proportional odds model was fitted using Proc Logistic in Statistical Analysis System (SAS), using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.0419|0.2023|
73842717|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|2.0|||||TWO_SIDED|95.0|-20.7|19.7||||||At risk subjects.||19.7|-20.7|
73842718|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|16.0|||||TWO_SIDED|95.0|12.6|20.1||||||No risk subjects.||20.1|12.6|
73959806|NCT00430300|147454782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5574|||||TWO_SIDED|95.0|0.1505|2.0647||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.0647|0.1505|
73959807|NCT00430300|147454782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.327|||||TWO_SIDED|95.0|0.083|1.2879||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||1.2879|0.0830|
73842719|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.6|9.8||||||No risk subjects||9.8|4.6|
73842720|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|15.0|||||TWO_SIDED|95.0|11.9|18.3||||||No risk subjects.||18.3|11.9|
73842721|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-2.0|||||TWO_SIDED|95.0|-28.5|20.2||||||At risk subjects.||20.2|-28.5|
73842722|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|11.0|||||TWO_SIDED|95.0|-14.9|33.5||||||At risk subjects.||33.5|-14.9|
73842723|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|10.0|||||TWO_SIDED|95.0|-14.0|29.3||||||At risk subjects.||29.3|-14|
73842724|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-3.8|9.5||||||No risk subjects.||9.5|-3.8|
73842725|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|3.0|||||TWO_SIDED|95.0|-1.8|10.0||||||No risk subjects.||10|-1.8|
74084273|NCT01525628|147721694|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|121.43|STANDARD_DEVIATION|24.7||0.3719|TWO_SIDED|90.0|104.24|141.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||141.45|104.24|0.3719
73842726|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|6.0|||||TWO_SIDED|95.0|1.5|12.5||||||No risk subjects.||12.5|1.5|
73842727|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-6.0|||||TWO_SIDED|95.0|-40.7|27.9||||||At risk subjects.||27.9|-40.7|
73842728|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-9.0|||||TWO_SIDED|95.0|-38.4|14.3||||||At risk subjects.||14.3|-38.4|
73842729|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|21.0|||||TWO_SIDED|95.0|-7.9|48.1||||||At risk subjects.||48.1|-7.9|
73842730|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|10.0|||||TWO_SIDED|95.0|3.0|18.5||||||No risk subjects.||18.5|3|
73842731|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|2.2|15.6||||||No risk subjects.||15.6|2.2|
73842732|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|4.0|||||TWO_SIDED|95.0|0.0|9.6||||||No risk subjects.||9.6|0|
73842733|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-5.0|||||TWO_SIDED|95.0|-41.7|35.0||||||At risk subjects.||35|-41.7|
73842734|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-9.0|||||TWO_SIDED|95.0|-38.6|23.4||||||At risk subjects.||23.4|-38.6|
73842735|NCT01346592|147233230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|0.0|||||TWO_SIDED|95.0|-26.9|31.0||||||At risk subjects.||31|-26.9|
73842736|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.29|||||TWO_SIDED|95.0|1.91|2.76||||||No risk subjects.||2.76|1.91|
73842737|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.6|||||TWO_SIDED|95.0|1.35|1.89||||||No risk subjects.||1.89|1.35|
73842738|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.92|||||TWO_SIDED|95.0|2.57|3.31||||||No risk subjects.||3.31|2.57|
73842739|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.53|||||TWO_SIDED|95.0|0.6|3.93||||||At risk subjects.||3.93|0.6|
73842740|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.02|||||TWO_SIDED|95.0|0.89|4.61||||||At risk subjects.||4.61|0.89|
73842741|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.5|||||TWO_SIDED|95.0|1.34|4.67||||||At risk subjects.||4.67|1.34|
73842742|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.33|||||TWO_SIDED|95.0|2.77|4.01||||||No risk subjects.||4.01|2.77|
73842743|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.07|||||TWO_SIDED|95.0|1.75|2.45||||||No risk subjects||2.45|1.75|
73842744|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.08|||||TWO_SIDED|95.0|2.72|3.49||||||No risk subjects||3.49|2.72|
73842745|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.71|||||TWO_SIDED|95.0|0.65|4.5||||||At risk subjects.||4.5|0.65|
73842746|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.22|||||TWO_SIDED|95.0|1.38|7.51||||||At risk subjects.||7.51|1.38|
73842747|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.1|||||TWO_SIDED|95.0|1.1|3.98||||||At risk subjects.||3.98|1.1|
73842748|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|2.59|||||TWO_SIDED|95.0|2.1|3.21||||||No risk subjects.||3.21|2.1|
73842749|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.08|||||TWO_SIDED|95.0|1.71|2.52||||||No risk subjects.||2.52|1.71|
73842750|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|3.73|||||TWO_SIDED|95.0|3.22|4.33||||||No risk subjects.||4.33|3.22|
73842751|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
73842752|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.86|||||TWO_SIDED|95.0|0.94|8.66||||||At risk subjects.||8.66|0.94|
73842753|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
73842754|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|3.67|||||TWO_SIDED|95.0|2.97|4.54||||||No risk subjects.||4.54|2.97|
73842755|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.78|||||TWO_SIDED|95.0|2.29|3.37||||||No risk subjects.||3.37|2.29|
73842756|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|4.01|||||TWO_SIDED|95.0|3.46|4.65||||||No risk subjects.||4.65|3.46|
73842757|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
73842758|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|4.32|||||TWO_SIDED|95.0|1.43|13.0||||||At risk subjects.||13|1.43|
73842759|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.69|||||TWO_SIDED|95.0|1.67|8.15||||||At risk subjects.||8.15|1.67|
73842760|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.35|||||TWO_SIDED|95.0|0.89|2.04||||||No risk subjects.||2.04|0.89|
73959808|NCT00430300|147454783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5709|||||TWO_SIDED|95.0|0.179|1.8204||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||1.8204|0.1790|
73842761|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.59|||||TWO_SIDED|95.0|1.14|2.22||||||No risk subjects.||2.22|1.14|
73959809|NCT00430300|147454783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6416|||||TWO_SIDED|95.0|0.1736|2.3715||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.3715|0.1736|
73842762|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.68|||||TWO_SIDED|95.0|1.3|2.15||||||No risk subjects.||2.15|1.3|
73842763|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.73|||||TWO_SIDED|95.0|0.29|10.0||||||At risk subjects.||10|0.29|
73842764|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.16|||||TWO_SIDED|95.0|0.33|4.01||||||At risk subjects.||4.01|0.33|
73842765|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.45|||||TWO_SIDED|95.0|0.53|3.94||||||At risk subjects.||3.94|0.53|
73842766|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.24|||||TWO_SIDED|95.0|1.48|3.39||||||No risk subjects||3.39|1.48|
73842767|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.76|||||TWO_SIDED|95.0|1.26|2.46||||||No risk subjects.||2.46|1.26|
73842768|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.59|||||TWO_SIDED|95.0|1.24|2.04||||||No risk subjects||2.04|1.24|
73842769|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.48|||||TWO_SIDED|95.0|0.34|18.0||||||At risk subjects.||18|0.34|
73842770|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.98|||||TWO_SIDED|95.0|0.49|7.92||||||At risk subjects.||7.92|0.49|
73842771|NCT01346592|147233231|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|0.71|||||TWO_SIDED|95.0|0.23|2.16||||||At risk subjects.||2.16|0.23|
73842772|NCT01346592|147233234|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|4.07|||||TWO_SIDED|95.0|3.34|4.95||||||GMTs were considered to be statistically significantly higher if the lower bound of the 95% confidence interval around the vaccine group ratio was \>1.0||4.95|3.34|
73842773|NCT01346592|147233234|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.95|||||TWO_SIDED|95.0|1.74|2.18||||||statistically significantly greater response was concluded if the lower bound of the 95% confidence interval around the vaccine group ratio is \>1.0||2.18|1.74|
73842774|NCT01346592|147233234|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|2.03|||||TWO_SIDED|95.0|1.73|2.39||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.39|1.73|
73842775|NCT01346592|147233234|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|3.82||||||95.0|3.14|4.64||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||4.64|3.14|
73842776|NCT01346592|147233234|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|2.4|||||TWO_SIDED|95.0|2.15|2.68||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.68|2.15|
73842777|NCT01346592|147233234|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.95|||||TWO_SIDED|95.0|1.65|2.29||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.29|1.65|
73842778|NCT02085720|147233250|NON_INFERIORITY_OR_EQUIVALENCE|Data were given as means and standard deviations, unless otherwise stated. AHI was categorized as ≥ 5, ≥ 10, ≥ 15 and ≥ 20. The frequency distribution of responses on the SHQ and their relationship to AHI was assessed with the chi-squared analysis. The association of variables such as age, BMI, neck circumference, ESS and sleep health questionnaire responses versus AHI was evaluated using one-way analysis of variance and Pearson Correlation Analysis.|||||<|0.05|||||||ANOVA|||||||<0.05
73842779|NCT04262479|147233287|OTHER||||||||||||||||||Counting number of events.|||
73842780|NCT04262479|147233288|OTHER||||||||||||||||||Counting number of events|||
73959810|NCT00430300|147454783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5877|||||TWO_SIDED|95.0|0.1516|2.2777||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.2777|0.1516|
73842781|NCT04262479|147233289|OTHER||||||<|0.001||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.001
73842782|NCT04262479|147233290|OTHER||||||<|0.05||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.05
73842783|NCT04262479|147233291|OTHER||||||<|0.61||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.61
73842784|NCT04262479|147233292|OTHER||||||<|0.3||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.30
73842785|NCT04262479|147233293|OTHER||||||<|0.002||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.002
73842786|NCT04262479|147233294|OTHER||||||<|0.72||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.72
73842787|NCT04262479|147233295|OTHER||||||<|0.03||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.03
73842788|NCT04262479|147233296|OTHER||||||<|0.044||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.044
73842789|NCT00937105|147233298|SUPERIORITY_OR_OTHER||Cumulative Probability of no-CIE|92.8|||||TWO_SIDED|95.0|88.6|96.9|||Kaplan-Meier|Cumulative Unadjusted Probability of remaining CIE-free presented for entire cohort (both solution groups) to remain consistent with the primary aim||Cumulative Unadjusted Probability of Remaining Infiltrate Free in entire Cohort||96.9|88.6|
73842790|NCT00937105|147233299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.737||||0.3923|TWO_SIDED|95.0|0.49|6.156|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial lens bioburden|To determine if microbial contamination of lenses is a risk factor for CIE||6.156|0.49|0.3923
73842791|NCT00937105|147233300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.316||||0.7943|TWO_SIDED|95.0|0.167|10.393|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no corneal staining|||10.393|0.167|0.7943
73842792|NCT00937105|147233301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.674||||0.5894|TWO_SIDED|95.0|0.161|2.822|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial case bioburden|||2.822|0.161|0.5894
73842793|NCT00937105|147233302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.406||||0.1742|TWO_SIDED|95.0|0.678|8.537||Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|Regression, Cox||referent is no substantial overall lid bioburden|||8.537|0.678|0.1742
73842794|NCT00937105|147233303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.22||||0.04|TWO_SIDED|95.0|1.1|24.7|||Regression, Cox|Multivariate model adjusted for solution, gender and age|referent is no substantial CNS lid bioburden|||24.70|1.10|0.04
73842795|NCT05395338|147233308|OTHER|cox proportional hazards models with stratification by matching pairs|Hazard Ratio (HR)|0.9||||0.183|TWO_SIDED|95.0|0.78|1.05|||Regression, Cox||rt-PA/non reperfusion|||1.05|0.78|0.183
73842796|NCT05395338|147233309|OTHER|Conditional logistic regression models with stratification by matching pairs.|Odds Ratio (OR)|1.25|||<|0.001|TWO_SIDED|95.0|1.12|1.39|||Regression, Logistic|||||1.39|1.12|<0.001
73842797|NCT05395338|147233310|OTHER|Conditional logistic regression models with stratification by matching pairs.|Odds Ratio (OR)|1.23|||<|0.001|TWO_SIDED|95.0|1.11|1.36|||Regression, Logistic||rt-PA/non reperfusion|||1.36|1.11|<0.001
73842798|NCT05395338|147233311|OTHER|Conditional logistic regression models with stratification by matching pairs|Odds Ratio (OR)|0.73|||<|0.001|TWO_SIDED|95.0|0.64|0.83|||Regression, Logistic||rt-PA/non reperfusion|||0.83|0.64|<0.001
73842799|NCT05395338|147233312|OTHER|Ordinal logistic regression models|Odds Ratio (OR)|0.85|||<|0.001|TWO_SIDED|95.0|0.77|0.93|||Regression, Logistic||rt-PA/non reperfusion|||0.93|0.77|<0.001
73842800|NCT01892189|147233315|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.2348|STANDARD_ERROR_OF_MEAN|0.20458||0.259|TWO_SIDED|95.0|-0.6506|0.1809|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using analysis of variance (ANOVA) model with sequence, period, regimen and participant nested within sequence as factors by regions of interest.||0.1809|-0.6506|0.259
73842801|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0367|STANDARD_ERROR_OF_MEAN|0.22075||0.869|TWO_SIDED|95.0|-0.4853|0.4119|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4119|-0.4853|0.869
73842802|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.218|STANDARD_ERROR_OF_MEAN|0.20968||0.306|TWO_SIDED|95.0|-0.6441|0.2081|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2081|-0.6441|0.306
73842803|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2525|STANDARD_ERROR_OF_MEAN|0.17956||0.169|TWO_SIDED|95.0|-0.6174|0.1124|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1124|-0.6174|0.169
73842804|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0417|STANDARD_ERROR_OF_MEAN|0.19375||0.831|TWO_SIDED|95.0|-0.4354|0.3521|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3521|-0.4354|0.831
73842805|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2421|STANDARD_ERROR_OF_MEAN|0.18403||0.197|TWO_SIDED|95.0|-0.6161|0.1319|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1319|-0.6161|0.197
73842806|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1155|STANDARD_ERROR_OF_MEAN|0.1618||0.48|TWO_SIDED|95.0|-0.4443|0.2133|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2133|-0.4443|0.480
73842807|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1673|STANDARD_ERROR_OF_MEAN|0.17458||0.345|TWO_SIDED|95.0|-0.1875|0.5221|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.5221|-0.1875|0.345
73842808|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1504|STANDARD_ERROR_OF_MEAN|0.16583||0.371|TWO_SIDED|95.0|-0.4874|0.1866|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1866|-0.4874|0.371
73842809|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1731|STANDARD_ERROR_OF_MEAN|0.18808||0.364|TWO_SIDED|95.0|-0.5553|0.2092|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2092|-0.5553|0.364
73842810|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1362|STANDARD_ERROR_OF_MEAN|0.20294||0.507|TWO_SIDED|95.0|-0.2762|0.5486|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.5486|-0.2762|0.507
73842811|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2464|STANDARD_ERROR_OF_MEAN|0.19276||0.21|TWO_SIDED|95.0|-0.6381|0.1453|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1453|-0.6381|0.210
73842812|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3059|STANDARD_ERROR_OF_MEAN|0.14253||0.039|TWO_SIDED|95.0|-0.5955|-0.0162|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0162|-0.5955|0.039
73842813|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0134|STANDARD_ERROR_OF_MEAN|0.1538||0.931|TWO_SIDED|95.0|-0.2991|0.326|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3260|-0.2991|0.931
74084274|NCT01525628|147721695|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|88.37|STANDARD_DEVIATION|20.8||0.1037|TWO_SIDED|90.0|77.39|100.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||100.89|77.39|0.1037
73842814|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1164|STANDARD_ERROR_OF_MEAN|0.14608||0.431|TWO_SIDED|95.0|-0.4133|0.1804|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1804|-0.4133|0.431
73842815|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3269|STANDARD_ERROR_OF_MEAN|0.13362||0.02|TWO_SIDED|95.0|-0.5985|-0.0554|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0554|-0.5985|0.020
73842816|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0845|STANDARD_ERROR_OF_MEAN|0.14418||0.562|TWO_SIDED|95.0|-0.3775|0.2085|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2085|-0.3775|0.562
73842817|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1727|STANDARD_ERROR_OF_MEAN|0.13695||0.216|TWO_SIDED|95.0|-0.451|0.1056|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1056|-0.4510|0.216
73842818|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0084|STANDARD_ERROR_OF_MEAN|0.17609||0.962|TWO_SIDED|95.0|-0.3663|0.3495|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3495|-0.3663|0.962
73842819|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0357|STANDARD_ERROR_OF_MEAN|0.19001||0.852|TWO_SIDED|95.0|-0.4218|0.3505|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3505|-0.4218|0.852
73842820|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2154|STANDARD_ERROR_OF_MEAN|0.18048||0.241|TWO_SIDED|95.0|-0.5822|0.1514|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1514|-0.5822|0.241
73842821|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.17766||0.443|TWO_SIDED|95.0|-0.4991|0.223|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2230|-0.4991|0.443
73842822|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2037|STANDARD_ERROR_OF_MEAN|0.1917||0.295|TWO_SIDED|95.0|-0.5933|0.1859|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1859|-0.5933|0.295
73842823|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0602|STANDARD_ERROR_OF_MEAN|0.18209||0.743|TWO_SIDED|95.0|-0.4303|0.3098|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3098|-0.4303|0.743
74022431|NCT01431287|147597108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.045|STANDARD_ERROR_OF_MEAN|0.137||0.7432|TWO_SIDED|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.223|-0.313|0.7432
73842824|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1774|STANDARD_ERROR_OF_MEAN|0.16068||0.277||95.0|-0.504|0.1491|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1491|-0.5040|0.277
73842825|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0539|STANDARD_ERROR_OF_MEAN|0.17338||0.758|TWO_SIDED|95.0|-0.4062|0.2985|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2985|-0.4062|0.758
73842826|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4377|STANDARD_ERROR_OF_MEAN|0.16468||0.012|TWO_SIDED|95.0|-0.7724|-0.1031|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.1031|-0.7724|0.012
74022432|NCT01431287|147597108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.136||0.8687|TWO_SIDED|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.245|-0.290|0.8687
73842827|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1037|STANDARD_ERROR_OF_MEAN|0.14849||0.49|TWO_SIDED|95.0|-0.4055|0.1981|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1981|-0.4055|0.490
73842828|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1007|STANDARD_ERROR_OF_MEAN|0.16023||0.534|TWO_SIDED|95.0|-0.4263|0.2249|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2249|-0.4263|0.534
73842829|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.15219||0.169|TWO_SIDED|95.0|-0.5233|0.0953|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0953|-0.5233|0.169
73842830|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2641|STANDARD_ERROR_OF_MEAN|0.14118||0.07|TWO_SIDED|95.0|-0.551|0.0228|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0228|-0.5510|0.070
73842831|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0854|STANDARD_ERROR_OF_MEAN|0.15234||0.579|TWO_SIDED|95.0|-0.395|0.2242|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2242|-0.3950|0.579
73842832|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2446|STANDARD_ERROR_OF_MEAN|0.1447||0.1|TWO_SIDED|95.0|-0.5387|0.0494|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0494|-0.5387|0.100
73842833|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13533||0.113|TWO_SIDED|95.0|-0.495|0.055|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0550|-0.4950|0.113
73842834|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0527|STANDARD_ERROR_OF_MEAN|0.14603||0.72|TWO_SIDED|95.0|-0.3495|0.244|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2440|-0.3495|0.720
73842835|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.183|STANDARD_ERROR_OF_MEAN|0.1387||0.196|TWO_SIDED|95.0|-0.4649|0.0989|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0989|-0.4649|0.196
73842836|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2051|STANDARD_ERROR_OF_MEAN|0.20032||0.313|TWO_SIDED|95.0|-0.6122|0.202|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2020|-0.6122|0.313
73842837|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0253|STANDARD_ERROR_OF_MEAN|0.21616||0.908|TWO_SIDED|95.0|-0.414|0.4646|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4646|-0.4140|0.908
73842838|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3042|STANDARD_ERROR_OF_MEAN|0.20531||0.148|TWO_SIDED|95.0|-0.7214|0.1131|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1131|-0.7214|0.148
73842839|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3409|STANDARD_ERROR_OF_MEAN|0.17997||0.067|TWO_SIDED|95.0|-0.7066|0.0249|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0249|-0.7066|0.067
74084275|NCT01525628|147721695|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|159.11|STANDARD_DEVIATION|57.8||0.8723|TWO_SIDED|90.0|111.06|227.93|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||227.93|111.06|0.8723
73842840|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0652|STANDARD_ERROR_OF_MEAN|0.19419||0.739|TWO_SIDED|95.0|-0.4599|0.3294|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3294|-0.4599|0.739
73842841|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4163|STANDARD_ERROR_OF_MEAN|0.18445||0.031|TWO_SIDED|95.0|-0.7912|-0.0415|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0415|-0.7912|0.031
73842842|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2032|STANDARD_ERROR_OF_MEAN|0.14369||0.166|TWO_SIDED|95.0|-0.4952|0.0888|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0888|-0.4952|0.166
73842843|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0932|STANDARD_ERROR_OF_MEAN|0.15504||0.552|TWO_SIDED|95.0|-0.2219|0.4083|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4083|-0.2219|0.552
73842844|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1648|STANDARD_ERROR_OF_MEAN|0.14727||0.271|TWO_SIDED|95.0|-0.4641|0.1345|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1345|-0.4641|0.271
73842845|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2516|STANDARD_ERROR_OF_MEAN|0.16169||0.129|TWO_SIDED|95.0|-0.5802|0.077|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0770|-0.5802|0.129
73842846|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1279|STANDARD_ERROR_OF_MEAN|0.17447||0.468|TWO_SIDED|95.0|-0.2266|0.4825|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4825|-0.2266|0.468
73842847|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2033|STANDARD_ERROR_OF_MEAN|0.16572||0.228|TWO_SIDED|95.0|-0.5401|0.1334|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1334|-0.5401|0.228
73842848|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13268||0.141|TWO_SIDED|95.0|-0.4696|0.0696|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0696|-0.4696|0.141
73842849|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0065|STANDARD_ERROR_OF_MEAN|0.14317||0.964|TWO_SIDED|95.0|-0.2975|0.2844|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2844|-0.2975|0.964
73842850|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1935|STANDARD_ERROR_OF_MEAN|0.13599||0.164|TWO_SIDED|95.0|-0.4699|0.0828|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0828|-0.4699|0.164
73842851|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1446|STANDARD_ERROR_OF_MEAN|0.13315||0.285|TWO_SIDED|95.0|-0.4152|0.126|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1260|-0.4152|0.285
73842852|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0176|STANDARD_ERROR_OF_MEAN|0.14368||0.903|TWO_SIDED|95.0|-0.3096|0.2744|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2744|-0.3096|0.903
73842853|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1615|STANDARD_ERROR_OF_MEAN|0.13647||0.245|TWO_SIDED|95.0|-0.4388|0.1159|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1159|-0.4388|0.245
73842854|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3659|STANDARD_ERROR_OF_MEAN|0.45708||0.429|TWO_SIDED|95.0|-0.563|1.2948|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.2948|-0.5630|0.429
73842855|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0395|STANDARD_ERROR_OF_MEAN|0.49321||0.937|TWO_SIDED|95.0|-0.9628|1.0419|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.0419|-0.9628|0.937
73863220|NCT03344640|147272630|SUPERIORITY||Difference and 90% CI vesus placebo|3.5||||0.411|TWO_SIDED|90.0|-3.54|10.54|||LS Mean|LS mean change from baseline in ASES total percentage score||Statistical analysis results of ASES total score (PD analysis) at day 99||10.54|-3.54|0.411
73842856|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7902|STANDARD_ERROR_OF_MEAN|0.46847||0.101|TWO_SIDED|95.0|-0.1618|1.7423|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.7423|-0.1618|0.101
73842857|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4404|STANDARD_ERROR_OF_MEAN|0.43756||0.321|TWO_SIDED|95.0|-1.3296|0.4488|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4488|-1.3296|0.321
73842858|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4685|STANDARD_ERROR_OF_MEAN|0.47214||0.328|TWO_SIDED|95.0|-1.428|0.491|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4910|-1.4280|0.328
73842859|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.44846||0.356|TWO_SIDED|95.0|-0.4914|1.3314|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.3314|-0.4914|0.356
73842860|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2254|STANDARD_ERROR_OF_MEAN|0.1679||0.188|TWO_SIDED|95.0|-0.5666|0.1158|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32. Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1158|-0.5666|0.188
73842861|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0232|STANDARD_ERROR_OF_MEAN|0.18117||0.899|TWO_SIDED|95.0|-0.3914|0.3449|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3449|-0.3914|0.899
73842862|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2534|STANDARD_ERROR_OF_MEAN|0.17208||0.15|TWO_SIDED|95.0|-0.6032|0.0963|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0963|-0.6032|0.150
73842863|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2821|STANDARD_ERROR_OF_MEAN|0.19038||0.148|TWO_SIDED|95.0|-0.669|0.1048|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA3: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1048|-0.6690|0.148
73842864|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.048|STANDARD_ERROR_OF_MEAN|0.20543||0.817|TWO_SIDED|95.0|-0.4655|0.3695|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3695|-0.4655|0.817
73842865|NCT01892189|147233315|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3395|STANDARD_ERROR_OF_MEAN|0.19513||0.091|TWO_SIDED|95.0|-0.7361|0.057|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0570|-0.7361|0.091
73842866|NCT03322566|147233333|SUPERIORITY||Difference in Percentages|-18.5||||0.9948|TWO_SIDED|95.0|-32.0|-4.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen method||Stratified by PD-L1 TPS ( \<50% vs. \>=50% ) and predominant tumor histology (squamous vs non-squamous);because of small sample size, the strata 'TPS \>= 50 percent Non-squamous' and 'TPS \>= 50% Squamous' were combined into one stratum.|||-4.3|-32.0|0.9948
73842867|NCT03322566|147233334|OTHER||Hazard Ratio (HR)|1.47||||0.94305|TWO_SIDED|95.0|0.91|2.36||One-sided p-value based on log-rank test stratified by TPS (\<50% vs \>=50%) and predominant histology (squamous vs non-squamous), because of small sample size, the strata 'TPS \>= 50% Non-squamous' and 'TPS \>= 50% Squamous' were combined into one.|Regression, Cox|Efron's method of tie handling||||2.36|0.91|0.94305
73842868|NCT03322566|147233335|OTHER||Hazard Ratio (HR)|1.9||||0.96272|TWO_SIDED|95.0|0.93|3.9||One-sided p-value based on log-rank test stratified by PD-L1 TPS (\<50% vs \>=50%) and predominant tumor histology (squamous vs non-squamous), because of small sample size, the strata (\<50% vs \>=50%) were combined into one stratum.|Regression, Cox|||||3.90|0.93|0.96272
73842869|NCT00376558|147233343|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|||||||0.003
73959811|NCT02023125|147454789|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|270.0|||||TWO_SIDED|90.0|228.0|320.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and confidence intervals (CIs).||320|228|
73959812|NCT02023125|147454790|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|116.0|||||TWO_SIDED|90.0|103.0|132.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||132|103|
73959813|NCT02023125|147454791|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|292.0|||||TWO_SIDED|90.0|258.0|329.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||329|258|
73842870|NCT00376558|147233344|SUPERIORITY_OR_OTHER||delta bpnd|-12.0|STANDARD_DEVIATION|7.0||0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||The limbic striatum was our primary region of interest using an unpaired t test to compare BPND and deltaBPND between the treatment responders and non-responders.||||0.001
73842871|NCT02314923|147233349|OTHER|||||||0.951|||||||ANOVA|||||||0.951
73842872|NCT02314923|147233349|OTHER|||||||0.458|||||||ANOVA|||||||0.458
73842873|NCT02314923|147233349|OTHER|||||||0.071|||||||ANOVA|||||||0.071
73842874|NCT02314923|147233349|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73842875|NCT02314923|147233349|OTHER|||||||0.029|||||||ANOVA|||||||0.029
73842876|NCT02314923|147233349|OTHER|||||||0.325|||||||ANOVA|||||||0.325
73842877|NCT02314923|147233349|OTHER|||||||0.003|||||||ANOVA|||||||0.003
73842878|NCT02314923|147233349|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
74084276|NCT01525628|147721695|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|259.57|STANDARD_DEVIATION|92.5||0.983|TWO_SIDED|90.0|150.65|447.21|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||447.21|150.65|0.9830
73842879|NCT02314923|147233349|OTHER|||||||0.427|||||||ANOVA|||||||0.427
73842880|NCT02314923|147233349|OTHER|||||||0.065|||||||ANOVA|||||||0.065
73842881|NCT02314923|147233349|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73842882|NCT02314923|147233349|OTHER|||||||0.027|||||||ANOVA|||||||0.027
73842883|NCT02314923|147233349|OTHER|||||||0.303|||||||ANOVA|||||||0.303
73842884|NCT02314923|147233349|OTHER|||||||0.003|||||||ANOVA|||||||0.003
73842885|NCT02314923|147233349|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73842886|NCT02314923|147233349|OTHER|||||||0.286|||||||ANOVA|||||||0.286
73842887|NCT02314923|147233349|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73842888|NCT02314923|147233349|OTHER|||||||0.094|||||||ANOVA|||||||0.094
73842889|NCT02314923|147233349|OTHER|||||||0.757|||||||ANOVA|||||||0.757
73842890|NCT02314923|147233349|OTHER|||||||0.022|||||||ANOVA|||||||0.022
73842891|NCT02314923|147233349|OTHER|||||||0.001|||||||ANOVA|||||||0.001
73842892|NCT02314923|147233349|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73842893|NCT02314923|147233349|OTHER|||||||0.348|||||||ANOVA|||||||0.348
73842894|NCT02314923|147233349|OTHER|||||||0.508|||||||ANOVA|||||||0.508
73842895|NCT02314923|147233349|OTHER|||||||0.191|||||||ANOVA|||||||0.191
73842896|NCT02314923|147233349|OTHER|||||||0.024|||||||ANOVA|||||||0.024
73842897|NCT02314923|147233349|OTHER|||||||0.169|||||||ANOVA|||||||0.169
73842898|NCT02314923|147233349|OTHER|||||||0.961|||||||ANOVA|||||||0.961
73842899|NCT02314923|147233349|OTHER|||||||0.454|||||||ANOVA|||||||0.454
73842900|NCT02314923|147233349|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73842901|NCT02314923|147233349|OTHER|||||||0.068|||||||ANOVA|||||||0.068
73842902|NCT02314923|147233349|OTHER|||||||0.007|||||||ANOVA|||||||0.007
73842903|NCT02314923|147233349|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73842904|NCT02314923|147233349|OTHER|||||||0.37|||||||ANOVA|||||||0.370
73842905|NCT02314923|147233349|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73842906|NCT00725985|147233354|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.381|||<|0.0001|TWO_SIDED|95.0|0.248|0.584||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.584|0.248|<0.0001
73842907|NCT00725985|147233354|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.327|||<|0.0001|TWO_SIDED|95.0|0.21|0.509||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.509|0.210|< 0.0001
73842908|NCT00725985|147233355|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.331|0.547||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.547|0.331|< 0.0001
73842909|NCT00725985|147233355|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.497|||<|0.0001|TWO_SIDED|95.0|0.39|0.633||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.633|0.390|< 0.0001
73842910|NCT00725985|147233356|SUPERIORITY||Median Difference (Final Values)|-0.667|||<|0.0001|TWO_SIDED|95.0|-0.971|-0.5|||ANCOVA|||CUA lesions||-0.500|-0.971|<0.0001
73842911|NCT00725985|147233356|SUPERIORITY||Median Difference (Final Values)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.857|-0.429|||ANCOVA|||CUA lesions||-0.429|-0.857|<0.0001
73842912|NCT00725985|147233356|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.333|-0.167|||ANCOVA|||T1 Gd-Enhancing Lesions||-0.167|-0.333|<0.0001
73842913|NCT00725985|147233356|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.375|-0.167|||ANCOVA|||T1 Gd-Enhancing Lesions||-0.167|-0.375|<0.0001
73842914|NCT00725985|147233356|SUPERIORITY||Median Difference (Final Values)|-0.333|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.167|||ANCOVA|||T2 Lesions||-0.167|-0.500|<0.0001
73842915|NCT00725985|147233356|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.429|-0.143|||ANCOVA|||T2 Lesions||-0.143|-0.429|<0.0001
73842916|NCT00725985|147233375|SUPERIORITY||Point Estimate|-1.7|||<|0.0001|TWO_SIDED|95.0|-37.2|0.0|||ANCOVA|||||0.000|-37.200|<0.0001
73842917|NCT00725985|147233375|SUPERIORITY||Point Estimate|-28.6|||<|0.0001|TWO_SIDED|95.0|-117.3|0.0|||ANCOVA|||||0.000|-117.300|<0.0001
73842918|NCT02546323|147233403|OTHER||Estimated mean difference|-0.0103|STANDARD_ERROR_OF_MEAN|0.00445||0.02|TWO_SIDED|95.0|-0.0191|-0.0016||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||-0.0016|-0.0191|0.020
73842919|NCT02546323|147233404|OTHER||Estimated mean difference|-0.011|STANDARD_ERROR_OF_MEAN|0.00442||0.013|TWO_SIDED|95.0|-0.0197|-0.0024||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||-0.0024|-0.0197|0.013
73842920|NCT02546323|147233405|OTHER||Estimated mean difference|-0.0162|STANDARD_ERROR_OF_MEAN|0.00903||0.073|TWO_SIDED|95.0|-0.0339|0.0015||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||0.0015|-0.0339|0.073
73842921|NCT02546323|147233406|OTHER||Estimated mean difference|-0.0043|STANDARD_ERROR_OF_MEAN|0.00716||0.547|TWO_SIDED|95.0|-0.0183|0.0097||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||0.0097|-0.0183|0.547
73842922|NCT02546323|147233407|OTHER||Estimated mean difference|-0.0086|STANDARD_ERROR_OF_MEAN|0.00272||0.002|TWO_SIDED|95.0|-0.0139|-0.0032||Statistical significance of the MeanMean CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients|Comparison of annualized rate of change in MeanMean CIMT measurement difference between rosuvastatin 20 mg and placebo||-0.0032|-0.0139|0.002
73842923|NCT02546323|147233408|OTHER||Least squares mean difference|-35.46|STANDARD_ERROR_OF_MEAN|2.426|<|0.001|TWO_SIDED|95.0|-40.23|-30.7|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C||-30.70|-40.23|<0.001
73842924|NCT02546323|147233408|OTHER||Least squares mean difference|-21.85|STANDARD_ERROR_OF_MEAN|1.441|<|0.001|TWO_SIDED|95.0|-24.68|-19.02|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol||-19.02|-24.68|<0.001
73842925|NCT02546323|147233408|OTHER||Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|1.347|<|0.001|TWO_SIDED|95.0|2.35|7.64|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C||7.64|2.35|<0.001
73842926|NCT02546323|147233408|OTHER||Least squares mean difference|-19.65|STANDARD_ERROR_OF_MEAN|3.671|<|0.001|TWO_SIDED|95.0|-26.86|-12.44|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides||-12.44|-26.86|<0.001
73842927|NCT02546323|147233408|OTHER||Least squares mean difference|-29.49|STANDARD_ERROR_OF_MEAN|1.917|<|0.001|TWO_SIDED|95.0|-33.25|-25.72|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C||-25.72|-33.25|<0.001
73842928|NCT02546323|147233408|OTHER||Least squares mean difference|-31.75|STANDARD_ERROR_OF_MEAN|2.334|<|0.001|TWO_SIDED|95.0|-36.33|-27.16|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio||-27.16|-36.33|<0.001
73842929|NCT02546323|147233408|OTHER||Least squares mean difference|-26.12|STANDARD_ERROR_OF_MEAN|1.84|<|0.001|TWO_SIDED|95.0|-29.73|-22.5|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB||-22.50|-29.73|<0.001
73842930|NCT02546323|147233408|OTHER||Least squares mean difference|2.19|STANDARD_ERROR_OF_MEAN|1.104||0.047|TWO_SIDED|95.0|0.02|4.36|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate|Treatment difference (rosuvastatin 20 mg - placebo): ApoA-I||4.36|0.02|0.047
73842931|NCT02546323|147233408|OTHER||Least squares mean difference|-26.77|STANDARD_ERROR_OF_MEAN|2.041|<|0.001|TWO_SIDED|95.0|-30.78|-22.76|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB/ApoA-I ratio||-22.76|-30.78|<0.001
73842932|NCT02546323|147233409|OTHER||Least squares mean difference|-39.51|STANDARD_ERROR_OF_MEAN|1.819|<|0.001|TWO_SIDED|95.0|-43.08|-35.94|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C||-35.94|-43.08|<0.001
73842933|NCT02546323|147233409|OTHER||Least squares mean difference|-25.46|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-27.7|-23.23|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol||-23.23|-27.70|<0.001
73842934|NCT02546323|147233409|OTHER||Least squares mean difference|3.67|STANDARD_ERROR_OF_MEAN|1.051|<|0.001|TWO_SIDED|95.0|1.6|5.73|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C||5.73|1.60|<0.001
73842935|NCT02546323|147233409|OTHER||Least squares mean difference|-18.41|STANDARD_ERROR_OF_MEAN|2.981|<|0.001|TWO_SIDED|95.0|-24.26|-12.55|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides||-12.55|-24.26|<0.001
73842936|NCT02546323|147233409|OTHER||Least squares mean difference|-33.78|STANDARD_ERROR_OF_MEAN|1.529|<|0.001|TWO_SIDED|95.0|-36.78|-30.78|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C||-30.78|-36.78|<0.001
73842937|NCT02546323|147233409|OTHER||Least squares mean difference|-33.93|STANDARD_ERROR_OF_MEAN|1.836|<|0.001|TWO_SIDED|95.0|-37.54|-30.32|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio||-30.32|-37.54|<0.001
73842938|NCT02947048|147233412|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.42||0.61|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Severity||||0.61
73842939|NCT02947048|147233412|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.52||0.33|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Severity||||0.33
73842940|NCT02947048|147233412|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.47||0.61|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Improvement||||0.61
73842941|NCT02947048|147233412|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.43||0.91|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Improvement||||0.91
73842942|NCT04047355|147233432|SUPERIORITY||Median Difference (Final Values)|3.0||||0.12|TWO_SIDED|||||The a-priori threshold for statistical significance was set at α = 0.05.|Wilcoxon (Mann-Whitney)||The placebo phase serves as the control condition and the propranolol phase serves as the treatment condition.|A post-hoc power analysis was conducted using G\*Power, v. 3.1, to determine the achieved power for the Wilcoxon signed-rank test for matched pairs.||||0.12
73842943|NCT04047355|147233432|SUPERIORITY||Effect size (r)|-0.64|||||TWO_SIDED|||||||||||||
73842944|NCT04047355|147233432|SUPERIORITY||Post-hoc power analysis|0.39|||||TWO_SIDED||||||||The alpha error probability was set at α = 0.05 (two-tailed).|||||
73842945|NCT04047355|147233433|SUPERIORITY||Median Difference (Final Values)|2.0||||0.07|TWO_SIDED|||||The a-priori threshold for statistical significance was set at α = 0.05.|Wilcoxon (Mann-Whitney)||The placebo phase serves as the control condition and the propranolol phase serves as the treatment condition.|A post-hoc power analysis was conducted using G\*Power, v. 3.1, to determine the achieved power for the Wilcoxon signed-rank test for matched pairs.||||0.07
73842946|NCT04047355|147233433|SUPERIORITY||Effect size (r)|-0.74|||||TWO_SIDED|||||||||||||
73842947|NCT04047355|147233433|SUPERIORITY||Post-hoc power analysis|0.59|||||TWO_SIDED||||||||The alpha error probability was set at α = 0.05 (two-tailed).|||||
73842948|NCT00721110|147233441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.96|TWO_SIDED|97.5|-52.0|54.0||Significant if P \< 0.003 for efficacy and P \> 0.5311 for futility; 97.5% confidence intervals adjusted for group sequential design to maintain the overall alpha of 0.025 for each primary intervention.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of lidocaine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.||54|-52|0.96
73842949|NCT00721110|147233441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.54|TWO_SIDED|97.5|-65.0|44.0||97.5% confidence interval adjusted for group sequential design (using confidence coefficient of 2.97) to maintain theoverall α of 0.025 for each primary intervention and 0.05 for the trial.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of ketamine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.||44|-65|0.54
73842950|NCT00721110|147233442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.2|TWO_SIDED|97.5|-3.3|1.3||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Groups compared on VRS scores at PACU admit using a t test.||1.3|-3.3|0.20
73842951|NCT00721110|147233442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.54|TWO_SIDED|97.5|-2.8|1.9||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine compared to placebo at PACU admit using a t test||1.9|-2.8|0.54
73842952|NCT00721110|147233442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.11|TWO_SIDED|97.5|-2.5|0.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on pain severity at postoperative care unit discharge was assessed using a t test.||0.8|-2.5|0.11
73842953|NCT00721110|147233442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.56|TWO_SIDED|97.5|-1.4|2.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative care unit discharge pain severity was assessed using a t test.||2.0|-1.4|0.56
73842954|NCT00721110|147233442|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.2|TWO_SIDED|97.5|-0.9|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 1 pain severity assessed using a t test.||2.2|-0.9|0.20
73842955|NCT00721110|147233442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.79|TWO_SIDED|97.5|-1.4|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 1 pain severity was assessed using a t test.||1.7|-1.4|0.79
73863221|NCT03344640|147272630|SUPERIORITY||Difference and 90% CI versus placebo|1.14||||0.804|TWO_SIDED|90.0|-6.5|8.78|||LS Mean|LS mean change from baseline in ASES total percentage score||Statistical analysis results of ASES total score (PD analysis) at End of Study set)||8.78|-6.50|0.804
73842956|NCT00721110|147233442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.55|TWO_SIDED|97.5|-1.1|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 2 pain severity was assessed using a t test.||1.7|-1.1|0.55
73842957|NCT00721110|147233442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.47|TWO_SIDED|97.5|-1.1|1.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 2 pain severity was assessed using a t test.||1.8|-1.1|0.47
73842958|NCT00721110|147233443|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.63|TWO_SIDED|97.5|-7.0|7.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on intraoperative opioid consumption was assessed using the Wilcoxon rank sum test.||7|-7|0.63
73842959|NCT00721110|147233443|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.0||||0.27|TWO_SIDED|97.5|-10.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on intraoperative opioid consumption was assessed using a Wilcoxon rank sum test.||5|-10|0.27
73842960|NCT00721110|147233443|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0||||0.28|TWO_SIDED|97.5|-15.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.||5|-15|0.28
73842961|NCT00721110|147233443|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0||||0.22|TWO_SIDED|97.5|-15.0|4.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.||4|-15|0.22
73842962|NCT00721110|147233443|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.76|TWO_SIDED|97.5|-13.0|21.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.||21|-13|0.76
73842963|NCT00721110|147233443|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0||||0.66|TWO_SIDED|97.5|-19.0|14.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.||14|-19|0.66
73842964|NCT00721110|147233443|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.3|TWO_SIDED|97.5|-5.0|10.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.||10|-5|0.30
73842965|NCT00721110|147233443|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.79|TWO_SIDED|97.5|-5.0|8.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.||8|-5|0.79
73842966|NCT00721110|147233444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.58|TWO_SIDED|97.5|-0.28|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||numerator: lidocaine; denominator: control|Lidocaine versus nonlidocaine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.||0.41|-0.28|0.58
73842967|NCT00721110|147233444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.02||||0.87|TWO_SIDED|97.5|-0.32|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||Numinator: ketamine; denominator: nonketamine|Ketamine versus nonketamine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.||0.36|-0.32|0.87
73842968|NCT00721110|147233444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.61|TWO_SIDED|97.5|-0.31|0.44||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on POD 1 (first postoperative day) nausea assessed using Pearson chi square test.||0.44|-0.31|0.61
73842969|NCT00721110|147233444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.03||||0.79|TWO_SIDED|97.5|-0.34|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on POD 1(first postoperative day) nausea assessed using Pearson chi square test.||0.41|-0.34|0.79
73959814|NCT02023125|147454792|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|122.0|||||TWO_SIDED|90.0|109.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||136|109|
73842970|NCT00721110|147233444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|-0.13||||0.26|TWO_SIDED|97.5|-0.38|0.12||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on PACU (postoperative care unit) vomiting assessed using Pearson chi square test.||0.12|-0.38|0.26
73842971|NCT00721110|147233444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|-0.06||||0.71|TWO_SIDED|97.5|-0.31|0.19||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on PACU (postoperative care unit) vomiting assessed using a Pearson chi square test.||0.19|-0.31|0.71
73842972|NCT00721110|147233444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.52|TWO_SIDED|97.5|-0.23|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on postoperative day 1 vomiting assessed using a Pearson chi square test.||0.36|-0.23|0.52
73842973|NCT00721110|147233444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.07||||0.44|TWO_SIDED|97.5|-0.22|0.38|||Chi-squared|||Ketamine versus nonketamine on postoperative day 1 vomiting assessed using Pearson chi square test.||0.38|-0.22|0.44
73842974|NCT00721110|147233445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.96|TWO_SIDED|97.5|-2.14|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine was compared to nonlidocaine on mean VRS fatigue score using a t test.||2.2|-2.14|0.96
73842975|NCT00721110|147233445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.59|TWO_SIDED|97.5|-1.8|2.57||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine was compared to nonketamine on mean VRS fatigue score using a t test.||2.57|-1.80|0.59
73842976|NCT01554904|147233456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|162.24|STANDARD_ERROR_OF_MEAN|62.4||0.02|TWO_SIDED|95.0|27.32|297.16|||paired t test|||The null hypothesis is that the snore index would not be different after 6 weeks of treatment compared to baseline. The comparison group is the subjects completing the 6 weeks of training and the second sleep study.||297.16|27.32|0.02
73842977|NCT01554904|147233457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.66||0.22|TWO_SIDED|95.0|-2.28|0.584||paired t test|t-test, 2 sided|||Participants completing 6 weeks of training and the second sleep study. The null hypothesis was that the AHI would not be different after 6 weeks of training compared to baseline.||0.584|-2.28|0.22
73842978|NCT02038647|147233475|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.113|TWO_SIDED|95.0|0.557|1.067||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.|||1.067|0.557|0.113
73842979|NCT02038647|147233477|SUPERIORITY||Cox Proportional Hazard|0.93||||0.714|TWO_SIDED|95.0|0.652|1.341||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.|||1.341|0.652|0.714
73842980|NCT02038647|147233478|SUPERIORITY||Odds Ratio (OR)|0.74||||0.406|TWO_SIDED|95.0|0.35|1.55||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using ORR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||1.55|0.35|0.406
73842981|NCT02038647|147233479|SUPERIORITY||Odds Ratio (OR)|0.01||||0.283|TWO_SIDED|95.0|0.01|9999.99||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using CRR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||9999.99|0.01|0.283
74022433|NCT01431287|147597108|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.137||0.8709|TWO_SIDED|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.246|-0.290|0.8709
73842982|NCT02038647|147233480|SUPERIORITY||Odds Ratio (OR)|0.59||||0.077|TWO_SIDED|95.0|0.32|1.08||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using DCR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||1.08|0.32|0.077
73842983|NCT02421094|147233509|SUPERIORITY|||||||0.1621|||||||ANCOVA|||||||0.1621
73842984|NCT02421094|147233510|SUPERIORITY|||||||0.9835|||||||ANCOVA|||||||0.9835
73842985|NCT02421094|147233511|SUPERIORITY|||||||0.266|||||||ANCOVA|||||||0.2660
73842986|NCT04716894|147233521|OTHER||adjusted geometric mean (gMean) ratio(%)|197.77|||||TWO_SIDED|90.0|187.9|208.15|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 7.0.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||208.15|187.90|
73863222|NCT03344640|147272631|SUPERIORITY||Difference and 90% CI versus placebo|-1.26||||0.706|TWO_SIDED|90.0|-6.81|4.29|||LS Mean|LS Mean change from baseline in Your Health Today Score at day 99||Statistical analysis results of Your Health Today EQ-5D-5L Index score at day 99 (PD Analysis Set)||4.29|-6.81|0.706
73842987|NCT04716894|147233522|OTHER||adjusted geometric mean (gMean) ratio(%)|143.38|||||TWO_SIDED|90.0|121.92|168.6|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 22.1.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||168.60|121.92|
73842988|NCT04716894|147233523|OTHER||adjusted geometric mean (gMean) ratio(%)|201.64|||||TWO_SIDED|90.0|192.23|211.52|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 6.5.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||211.52|192.23|
73842989|NCT03863574|147233524|OTHER|Proof of Concept||||||0.7689|||||||t-test, 2 sided|||||||0.7689
73842990|NCT03863574|147233524|OTHER|Proof-of-concept||||||0.6007|||||||t-test, 2 sided|||||||0.6007
73842991|NCT03863574|147233525|OTHER|||||||0.5238|||||||Fisher Exact|||||||0.5238
73842992|NCT03863574|147233525|OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
73842993|NCT03863574|147233526|OTHER|Proof-of-concept||||||0.0476|||||||Fisher Exact|||||||0.0476
73842994|NCT03863574|147233526|OTHER|Proof-of-concept||||||0.0333|||||||Fisher Exact|||||||0.0333
73842995|NCT03863574|147233527|OTHER|Proof-of-concept||||||0.6845|||||||t-test, 2 sided|||Outcome Variable: Steatosis||||0.6845
73842996|NCT03863574|147233527|OTHER|Proof-of-concept||||||0.4625|||||||t-test, 2 sided|||Outcome Variable: Steatosis||||0.4625
73842997|NCT03863574|147233527|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||Outcome Variable: Lobular Inflammation||||0.1705
73842998|NCT03863574|147233527|OTHER|Proof-of-concept||||||0.3122|||||||t-test, 2 sided|||Outcome variable: Lobular Inflammation||||0.3122
73842999|NCT03863574|147233527|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||Outcome Variable: Hepatocyte Ballooning||||0.1705
73843000|NCT03863574|147233527|OTHER|Proof-of-concept||||||0.3877|||||||t-test, 2 sided|||Outcome Variable: Hepatocyte Ballooning||||0.3877
73843001|NCT03863574|147233528|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||||||0.1705
73843002|NCT03863574|147233528|OTHER|Proof-of-concept||||||0.174|||||||t-test, 2 sided|||||||0.1740
73843003|NCT03863574|147233529|OTHER|Proof-of-concept||||||0.8019|||||||t-test, 2 sided|||Outcome variable: Alanine Aminotransferase||||0.8019
73843004|NCT03863574|147233529|OTHER|Proof-of-concept||||||0.5396|||||||t-test, 2 sided|||Outcome Variable: Alanine Aminotransferase||||0.5396
73843005|NCT03863574|147233529|OTHER|Proof-of-concept||||||0.774|||||||t-test, 2 sided|||Outcome Variable: Aspartate Aminotransferase||||0.7740
73843006|NCT03863574|147233529|OTHER|Proof-of-concept||||||0.9221|||||||t-test, 2 sided|||Outcome Variable: Aspartate Aminotransferase||||0.9221
73843007|NCT03863574|147233529|OTHER|Proof-of-concept||||||0.003|||||||t-test, 2 sided|||Outcome Variable: Alkaline Phosphatase||||0.0030
73843008|NCT03863574|147233529|OTHER|Proof-of-concept||||||0.0177|||||||t-test, 2 sided|||Outcome Variable: Alkaline Phosphatase||||0.0177
73843009|NCT03863574|147233529|OTHER|Proof-of-concept||||||0.1399|||||||t-test, 2 sided|||Outcome Variable: Gamma Glutamyl Transferase||||0.1399
73843010|NCT03863574|147233529|OTHER|Proof-of-concept||||||0.2384|||||||t-test, 2 sided|||Outcome Variable: Gamma Glutamyl Transferase||||0.2384
73843011|NCT03863574|147233530|OTHER|Proof-of-concept||||||0.2218|||||||t-test, 2 sided|||Outcome Variable: Albumin||||0.2218
73843012|NCT03863574|147233530|OTHER|Proof-of-Concept||||||0.1483|||||||t-test, 2 sided|||Outcome Variable: Albumin||||0.1483
73843013|NCT03863574|147233530|OTHER|Proof-of-concept||||||0.0839|||||||t-test, 2 sided|||Outcome Variable: Total Protein||||0.0839
73843014|NCT03863574|147233530|OTHER|Proof-of-concept||||||0.2895|||||||t-test, 2 sided|||Outcome Variable: Total Protein||||0.2895
73843015|NCT03863574|147233531|OTHER|Proof-of-concept||||||0.6808|||||||t-test, 2 sided|||Outcome Variable: Direct Bilirubin||||0.6808
73843016|NCT03863574|147233531|OTHER|Proof-of-concept||||||0.5351|||||||t-test, 2 sided|||Outcome Variable: Direct Bilirubin||||0.5351
73843017|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.2329|||||||t-test, 2 sided|||Outcome Variable: Triglyceride||||0.2329
73843018|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.7211|||||||t-test, 2 sided|||Outcome Variable: Triglyceride||||0.7211
73843019|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.652|||||||t-test, 2 sided|||Outcome Variables: Total Cholesterol||||0.6520
73843020|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.4302|||||||t-test, 2 sided|||Outcome Variable: Total Cholesterol||||0.4302
73843021|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.9432|||||||t-test, 2 sided|||Outcome Variable: High-density Lipoprotein||||0.9432
73843022|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.2133|||||||t-test, 2 sided|||Outcome Variable: High-density Lipoprotein||||0.2133
73843023|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.2446|||||||t-test, 2 sided|||Outcome Variable: Low-density lipoprotein||||0.2446
73843024|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.7075|||||||t-test, 2 sided|||Outcome Variable: Low-density lipoprotein||||0.7075
73843025|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.2195|||||||t-test, 2 sided|||Outcome Variable: Very low-density lipoprotein||||0.2195
73843026|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.7435|||||||t-test, 2 sided|||Outcome Variable: Very low-density lipoprotein||||0.7435
73843027|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.5702|||||||t-test, 2 sided|||Outcome Variable: non-HDL Cholesterol||||0.5702
73843028|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.6441|||||||t-test, 2 sided|||Outcome Variable: non-HDL Cholesterol||||0.6441
73843029|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.8415|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein A1||||0.8415
73843030|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.0786|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein A1||||0.0786
73843031|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.8878|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein B||||0.8878
73843032|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.3219|||||||t-test, 2 sided|||Outcome variable: Apo lipoprotein B||||0.3219
73843033|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.6557|||||||t-test, 2 sided|||Outcome Variable: Small dense LDL||||0.6557
73843034|NCT03863574|147233532|OTHER|Proof-of-concept||||||0.0763|||||||t-test, 2 sided|||Outcome Variable: Small dense LDL||||0.0763
73843035|NCT03863574|147233534|OTHER|Proof-of-concept||||||0.6988|||||||t-test, 2 sided|||||||0.6988
73843036|NCT03863574|147233534|OTHER|Proof-of-concept||||||0.7413|||||||t-test, 2 sided|||||||0.7413
73843037|NCT03863574|147233535|OTHER|Proof-of-concept||||||0.22|||||||t-test, 2 sided|||||||0.2200
73843038|NCT03863574|147233535|OTHER|Proof-of-concept||||||0.5798|||||||t-test, 2 sided|||||||0.5798
73843039|NCT03863574|147233536|OTHER|Proof-of-concept||||||0.4981|||||||t-test, 2 sided|||||||0.4981
73843040|NCT03863574|147233536|OTHER|Proof-of-concept||||||0.8939|||||||t-test, 2 sided|||||||0.8939
73843041|NCT03863574|147233537|OTHER|Proof-of-concept||||||0.3605|||||||t-test, 2 sided|||||||0.3605
73843042|NCT03863574|147233537|OTHER|Proof-of-concept||||||0.8394|||||||t-test, 2 sided|||||||0.8394
74084277|NCT01525628|147721695|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|163.95|STANDARD_DEVIATION|38.1||0.9689|TWO_SIDED|90.0|129.52|207.52|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||207.52|129.52|0.9689
73843043|NCT03863574|147233538|OTHER|Proof-of-concept||||||0.2665|||||||t-test, 2 sided|||||||0.2665
73843044|NCT03863574|147233538|OTHER|Proof-of-concept||||||0.9133|||||||t-test, 2 sided|||||||0.9133
73843045|NCT03863574|147233539|OTHER|Proof-of-concept||||||0.7267|||||||t-test, 2 sided|||||||0.7267
73843046|NCT03863574|147233539|OTHER|Proof-of-concept||||||0.9211|||||||t-test, 2 sided|||||||0.9211
73959815|NCT02023125|147454793|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|377.0|||||TWO_SIDED|90.0|303.0|468.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||468|303|
73959816|NCT02023125|147454794|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|102.0|||||TWO_SIDED|90.0|87.0|119.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||119|87.0|
73959817|NCT02023125|147454795|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|328.0|||||TWO_SIDED|90.0|276.0|389.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||389|276|
73843047|NCT03863574|147233540|OTHER|Proof-of-concept||||||0.8683|||||||t-test, 2 sided|||||||0.8683
73843048|NCT03863574|147233540|OTHER|Proof-of-concept||||||0.7436|||||||t-test, 2 sided|||||||0.7436
73843049|NCT00071032|147233560|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.84|1.22|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)|||1.22|0.84|
73843050|NCT00071032|147233561|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.9|||||TWO_SIDED|99.0|-3.3|1.6|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)|||1.6|-3.3|
73843051|NCT05078112|147233593|OTHER|||||||0.000393|||||||t-test, 2 sided|||||||0.000393
73843052|NCT01903863|147233597|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
73843053|NCT01903863|147233598|SUPERIORITY|||||||0.07||||||Intracranial hemorrhage|Fisher Exact|||||||0.07
73843054|NCT01903863|147233598|SUPERIORITY|||||||0.7||||||Surgical bleed|Fisher Exact|||||||0.7
73843055|NCT01903863|147233598|SUPERIORITY|||||||0.5||||||Gastrointestinal hemorrhage|Fisher Exact|||||||0.5
73843056|NCT01903863|147233599|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73843057|NCT01903863|147233600|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
73843058|NCT01903863|147233601|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
73843059|NCT01903863|147233602|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
73843060|NCT01903863|147233603|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
73843061|NCT01903863|147233604|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
73843062|NCT01969058|147233615|SUPERIORITY|||||||0.03||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two arms in the change in T-cell activation from baseline to week 14/16.||||0.030
73843063|NCT05318287|147233646|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.03||0.083|TWO_SIDED||||||t-test, 2 sided|||||||.083
73843064|NCT05318287|147233647|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||t-test, 2 sided|||||||.010
73843065|NCT05318287|147233648|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.16|TWO_SIDED||||||t-test, 2 sided|||||||.160
73843066|NCT05318287|147233649|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.167|TWO_SIDED||||||t-test, 2 sided|||||||.167
73843067|NCT05318287|147233650|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.012|TWO_SIDED||||||t-test, 2 sided|||||||.012
73843068|NCT05318287|147233651|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.347|TWO_SIDED||||||t-test, 2 sided|||||||.347
73843069|NCT05318287|147233652|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.007|TWO_SIDED||||||t-test, 2 sided|||||||.007
73843070|NCT05318287|147233653|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.02||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
73843071|NCT05318287|147233654|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.403|TWO_SIDED||||||t-test, 2 sided|||||||.403
73843072|NCT05318287|147233655|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.194|TWO_SIDED||||||t-test, 2 sided|||||||.194
73843073|NCT03537508|147233660|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|1.86|||||TWO_SIDED|95.0|-4.38|8.64||||||Statistical analysis for Serogroup A||8.64|-4.38|
73843074|NCT03537508|147233660|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|8.75|||||TWO_SIDED|95.0|4.8|13.6||||||Statistical analysis for Serogroup C||13.60|4.80|
73843075|NCT03537508|147233660|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|4.09|||||TWO_SIDED|95.0|0.68|8.44||||||Statistical analysis for Serogroup Y||8.44|0.68|
73843076|NCT03537508|147233660|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|1.19|||||TWO_SIDED|95.0|-1.18|4.45||||||Statistical analysis for Serogroup W||4.45|-1.18|
73843077|NCT03537508|147233661|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|10.21|||||TWO_SIDED|95.0|4.98|15.59||||||Statistical analysis for Serogroup A||15.59|4.98|
73843078|NCT03537508|147233661|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|7.83|||||TWO_SIDED|95.0|5.31|10.96||||||Statistical analysis for Serogroup C||10.96|5.31|
73843079|NCT03537508|147233661|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|6.53|||||TWO_SIDED|95.0|4.01|9.62||||||Statistical analysis for Serogroup Y||9.62|4.01|
73843080|NCT03537508|147233661|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|5.72|||||TWO_SIDED|95.0|3.44|8.57||||||Statistical analysis for Serogroup W||8.57|3.44|
73843081|NCT00391716|147233726|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.|Mantel Haenszel|Extended Mantel-Haenszel Chi-square test for linear-by-linear association.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= non-abstinent, 1=abstinent), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.||||<0.04
73843082|NCT00391716|147233726|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED|||||linear dose effects for rates of abstinence were assessed using the extended Mantel-Haenszel chi-square test for linear association.|Mantel Haenszel|The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= heavy drinking, 1=no heavy drinking), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.||||<0.02
73843083|NCT00391716|147233727|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Cumulative means over 12 weeks|ANOVA|||||||<0.001
73959818|NCT02023125|147454796|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|110.0|||||TWO_SIDED|90.0|96.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||126|96.3|
74084278|NCT01525628|147721695|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|219.88|STANDARD_DEVIATION|70.4||0.9933|TWO_SIDED|90.0|153.84|314.26|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||314.26|153.84|0.9933
73843084|NCT00391716|147233728|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Cumulative means over 12 weeks|ANOVA|||||||<0.001
73843085|NCT00391716|147233729|SUPERIORITY_OR_OTHER||||||<|0.003||||||Cumulative means over 12 weeks|ANOVA|||||||<0.003
73843086|NCT00934180|147233747|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.0||||||90.0|95.1|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|95.1|
73843087|NCT00934180|147233748|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.3|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|95.3|
73843088|NCT00934180|147233749|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.2|108.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108|95.2|
73843089|NCT00835172|147233750|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|92.1|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|92.1|
73843090|NCT00835172|147233751|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|96.8|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|96.8|
73843091|NCT00835172|147233752|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.0||||||90.0|99.3|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|99.3|
73843092|NCT00791648|147233790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Pearson x2|||||||.75
73843093|NCT00791648|147233791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||.56
73843094|NCT00791648|147233792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||.71
73843095|NCT00791648|147233793|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||.11
73843096|NCT00791648|147233794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
73843097|NCT00791648|147233795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
73959819|NCT02023125|147454799|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|306.0|||||TWO_SIDED|90.0|269.0|348.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||348|269|
73959820|NCT02023125|147454800|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|122.0|||||TWO_SIDED|90.0|110.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||136|110|
73959821|NCT02023125|147454801|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|349.0|||||TWO_SIDED|90.0|288.0|422.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||422|288|
73959822|NCT02023125|147454802|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|109.0|||||TWO_SIDED|90.0|95.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||126|95.3|
73843098|NCT02947984|147233813|OTHER|||||||0.234|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the overall cohort.||||0.234
73843099|NCT02947984|147233813|OTHER|||||||0.82|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the subgroup receiving treatment due to a sub-total resection||||.820
73843100|NCT02947984|147233813|OTHER|||||||0.061|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the sub-group receiving treatment due to recurrent disease||||.061
73843101|NCT05870345|147233848|OTHER|Sample size too small to perform additional statistical tests.|||||||||||||||||Sample size too small to perform additional statistical tests.|||
73843102|NCT05870345|147233849|OTHER|Sample size too small to perform additional statistical tests.|||||||||||||||||Sample size too small to perform additional statistical tests.|||
73843103|NCT03898180|147233881|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.4107|TWO_SIDED|95.0|0.72|1.14||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, programmed cell death ligand 1 (PD-L1) CPS, and ECOG performance status (PS).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.14|0.72|0.4107
73843104|NCT03898180|147233882|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.3505|TWO_SIDED|95.0|0.87|1.48||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.48|0.87|0.3505
73843105|NCT03898180|147233883|SUPERIORITY||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-4.0|12.2|||||Based on Miettinen \& Nurminen method stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||12.2|-4.0|
73843106|NCT03898180|147233886|OTHER||Difference in least squares means|-3.07||||0.182|TWO_SIDED|95.0|-7.57|1.44||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|cLDA model||Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.44|-7.57|0.182
73843107|NCT03898180|147233887|OTHER||Hazard Ratio (HR)|1.64||||0.0005|TWO_SIDED|95.0|1.24|2.16||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||2.16|1.24|0.0005
73843108|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|8.56||||0.0129|TWO_SIDED|95.0|2.41|14.72||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Foreign body sensation - Left eye||14.72|2.41|0.0129
73843109|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|7.58||||0.0077|TWO_SIDED|95.0|1.7|13.45||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Foreign body sensation - Right eye||13.45|1.70|0.0077
73843110|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|3.99||||0.1589|TWO_SIDED|95.0|-1.64|9.62||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Burning/ Stinging - Left eye||9.62|-1.64|0.1589
73863223|NCT03344640|147272631|SUPERIORITY||Difference and 90% CI versus placebo|-1.9||||0.647|TWO_SIDED|90.0|-8.79|4.99|||LS Mean|LS mean change from baseline in Your Health Today score||Statistical analysis results of Your Health Today EQ-5D-5L Index score at End of Study||4.99|-8.79|0.647
73843111|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|2.78||||0.3167|TWO_SIDED|95.0|-2.78|8.35||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Burning/ Stinging - Right eye||8.35|-2.78|0.3167
73843112|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.5243|TWO_SIDED|95.0|-7.64|3.96||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Itching - Left eye||3.96|-7.64|0.5243
73843113|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.6714|TWO_SIDED|95.0|-4.45|6.82||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Itching - Right eye||6.82|-4.45|0.6714
73843114|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|-3.89||||0.0828|TWO_SIDED|95.0|-8.31|0.53||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Pain - Left eye||0.53|-8.31|0.0828
73843115|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.7823|TWO_SIDED|95.0|-4.77|3.62||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Pain - Right eye||3.62|-4.77|0.7823
73843116|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|4.93||||0.0432|TWO_SIDED|95.0|0.16|9.7||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Sticky feeling - Left eye||9.70|0.16|0.0432
73843117|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|6.35||||0.0088|TWO_SIDED|95.0|1.7|11.0||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Sticky feeling - Right eye||11.00|1.70|0.0088
73843118|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|9.28||||0.0013|TWO_SIDED|95.0|3.9|14.66||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Blurred vision - Left eye||14.66|3.90|0.0013
74022434|NCT01431287|147597109|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.63|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.898|0.362|<0.0001
73843119|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|5.31||||0.00629|TWO_SIDED|95.0|-0.3|10.92||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Blurred vision - Right eye||10.92|-0.30|0.00629
73843120|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|9.92||||0.002|TWO_SIDED|95.0|3.89|15.95||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Photophobia - Left eye||15.95|3.89|0.0020
73843121|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|7.95||||0.0111|TWO_SIDED|95.0|1.93|13.97||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Photophobia - Right eye||13.97|1.93|0.0111
73843122|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|31.67||||0.0448|TWO_SIDED|95.0|0.78|62.56||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Total score ocular tolerability - Left eye||62.56|0.78|0.0448
73843123|NCT02507934|147233890|SUPERIORITY||Mean Difference (Final Values)|26.36||||0.0834|TWO_SIDED|95.0|-3.66|56.37||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Total score ocular tolerability - Right eye||56.37|-3.66|0.0834
73843124|NCT02507934|147233892|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.2317|TWO_SIDED|95.0|-0.14|0.57|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 7 ±1||0.57|-0.14|0.2317
73843125|NCT02507934|147233892|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.6017|TWO_SIDED|95.0|-0.7|0.41|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 7 ±1||0.41|-0.70|0.6017
73843126|NCT02507934|147233892|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.0232|TWO_SIDED|95.0|0.11|1.36|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 14 ±1||1.36|0.11|0.0232
73843127|NCT02507934|147233892|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.0398|TWO_SIDED|95.0|0.03|1.17|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 14 ±1||1.17|0.03|0.0398
73843128|NCT02507934|147233892|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.0038|TWO_SIDED|95.0|0.36|1.74|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 21 ±1||1.74|0.36|0.0038
73843129|NCT02507934|147233892|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.0135|TWO_SIDED|95.0|0.17|1.33|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - right eye||1.33|0.17|0.0135
73843130|NCT02507934|147233893|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.3442|TWO_SIDED|95.0|-0.66|1.83|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 7±1||1.83|-0.66|0.3442
73843131|NCT02507934|147233893|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.772|TWO_SIDED|95.0|-1.99|1.49|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 7±1||1.49|-1.99|0.7720
73843132|NCT02507934|147233893|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.9725|TWO_SIDED|95.0|-1.49|1.44|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 14±1||1.44|-1.49|0.9725
73843133|NCT02507934|147233893|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.2111|TWO_SIDED|95.0|-3.54|0.81|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 14±1||0.81|-3.54|0.2111
73843134|NCT02507934|147233893|SUPERIORITY||Median Difference (Final Values)|-1.1||||0.2629|TWO_SIDED|90.0|-3.06|0.86|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 21±1||0.86|-3.06|0.2629
73959823|NCT02666742|147454817|SUPERIORITY|Continuous variables were compared by two-sample t-tests and categorical variables by chi-square test. All tests were two-tailed, and a P value less than 0.05 was considered to indicate statistical significance. Bonferroni correction was not performed due to prespecified outcomes in the trial. Analyses were performed using GraphPad 6||||||0.001|||||||Chi-squared|||Due to lack of precedent robust clinical data, we performed exploratory study to evaluate safety and efficacy of DOAC vs. Aspirin (ASA) in patients undergoing left ventricular arrhythmia (LVA) ablation; therefore, sample size calculation was not undertaken.||||0.001
74084279|NCT01525628|147721695|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|214.4|STANDARD_DEVIATION|66.8||0.9865|TWO_SIDED|90.0|145.88|315.09|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||315.09|145.88|0.9865
73843135|NCT02507934|147233893|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.2862|TWO_SIDED|95.0|-3.6|1.1|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - 21±1||1.10|-3.60|0.2862
73843136|NCT02507934|147233894|SUPERIORITY||Mean Difference (Final Values)|11.24||||0.2075|TWO_SIDED|95.0|-6.66|29.14|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 7±1||29.14|-6.66|0.2075
73843137|NCT02507934|147233894|SUPERIORITY||Mean Difference (Final Values)|18.16||||0.0435|TWO_SIDED|95.0|0.57|35.76|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 14±1||35.76|0.57|0.0435
73843138|NCT02507934|147233894|SUPERIORITY||Mean Difference (Final Values)|23.58||||0.0133|TWO_SIDED|95.0|5.24|41.93|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 21±1||41.93|5.24|0.0133
73843139|NCT02507934|147233895|SUPERIORITY||Mean Difference (Final Values)|4.36||||0.613|TWO_SIDED|95.0|-12.98|21.69|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 7±1||21.69|-12.98|0.6130
73843140|NCT02507934|147233895|SUPERIORITY||Mean Difference (Final Values)|12.7||||0.1047|TWO_SIDED|95.0|-2.78|28.18|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 14±1||28.18|-2.78|0.1047
73843141|NCT02507934|147233895|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.1108|TWO_SIDED|95.0|-3.24|30.04|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 21±1||30.04|-3.24|0.1108
73843142|NCT02507934|147233896|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.498|TWO_SIDED|95.0|-0.4|0.81|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 7±1||0.81|-0.40|0.4980
73843143|NCT02507934|147233896|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.1986|TWO_SIDED|95.0|-0.18|0.83|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 7±1||0.83|-0.18|0.1986
73843144|NCT02507934|147233896|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.4067|TWO_SIDED|95.0|-0.9|0.37|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 14±1||0.37|-0.90|0.4067
73843145|NCT02507934|147233896|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.5256|TWO_SIDED|95.0|-0.81|0.42|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 14±1||0.42|-0.81|0.5256
73843146|NCT02507934|147233896|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.1471|TWO_SIDED|95.0|-1.12|0.17|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 21±1||0.17|-1.12|0.1471
73843147|NCT02507934|147233896|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.2455|TWO_SIDED|95.0|-0.96|0.25|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 21±1||0.25|-0.96|0.2455
73843148|NCT02507934|147233897|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.4233|TWO_SIDED|95.0|-1.98|0.85|||Student t-test for unpaired data|||T test p-value - Left eye - Day 7±1||0.85|-1.98|0.4233
73843149|NCT02507934|147233897|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.6335|TWO_SIDED|95.0|-1.04|1.69|||Student t-test for unpaired data|||T test p-value - Right eye - Day 7±1||1.69|-1.04|0.6335
73843150|NCT02507934|147233897|SUPERIORITY||Mean Difference (Final Values)|-2.04||||0.0103|TWO_SIDED|95.0|-3.56|-0.51|||Student t-test for unpaired data|||T test p-value - Left eye - Day 14±1||-0.51|-3.56|0.0103
73843151|NCT02507934|147233897|SUPERIORITY||Mean Difference (Final Values)|-1.34||||0.1006|TWO_SIDED|95.0|-2.95|0.27|||Student t-test for unpaired data|||T test p-value - Right eye - Day 14±1||0.27|-2.95|0.1006
73843152|NCT02507934|147233897|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0041|TWO_SIDED|95.0|-4.15|-0.85|||Student t-test for unpaired data|||T test p-value - Left eye - Day 21±1||-0.85|-4.15|0.0041
73843153|NCT02507934|147233897|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.0429|TWO_SIDED|95.0|-3.67|-0.06|||Student t-test for unpaired data|||T test p-value - Right eye - Day 21±1||-0.06|-3.67|0.0429
73843154|NCT02507934|147233898|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.2338|TWO_SIDED|95.0|-0.75|0.19|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 7±1||0.19|-0.75|0.2338
73843155|NCT02507934|147233898|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.3081|TWO_SIDED|95.0|-0.58|0.19|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 7±1||0.19|-0.58|0.3081
73843156|NCT02507934|147233898|SUPERIORITY||Mean Difference (Final Values)|1.59||||0.4287|TWO_SIDED|95.0|-2.57|5.74|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 14±1||5.74|-2.57|0.4287
73843157|NCT02507934|147233898|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.5765|TWO_SIDED|95.0|-3.14|5.44|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 14±1||5.44|-3.14|0.5765
73843158|NCT02507934|147233898|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.0259|TWO_SIDED|95.0|-2.18|-0.15|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 21±1||-0.15|-2.18|0.0259
73959824|NCT01049503|147454832|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by 2-way RM-ANOVA after logarithmic transformation and Bonferroni's test."||||<0.05
73959825|NCT01049503|147454833|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
73959826|NCT01049503|147454834|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
73843159|NCT02507934|147233898|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.1496|TWO_SIDED|95.0|-2.23|0.37|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 21±1||0.37|-2.23|0.1496
73843160|NCT02507934|147233899|SUPERIORITY|||||||0.2342|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 7±1||||0.2342
73843161|NCT02507934|147233899|SUPERIORITY|||||||0.8874|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 7±1||||0.8874
73843162|NCT02507934|147233899|SUPERIORITY|||||||0.0504|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 7±1||||0.0504
73843163|NCT02507934|147233899|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 7±1||||0.0814
73843164|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 7±1||||1.0000
73843165|NCT02507934|147233899|SUPERIORITY|||||||0.3855|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 7±1||||0.3855
73843166|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 7±1||||1.0000
73843167|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 7±1||||1.0000
73843168|NCT02507934|147233899|SUPERIORITY|||||||0.4754|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 7±1||||0.4754
73843169|NCT02507934|147233899|SUPERIORITY|||||||0.2914|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 7±1||||0.2914
73843170|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 7±1||||1.0000
73843171|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 7±1||||1.0000
73843172|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 7±1||||1.0000
73843173|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 7±1||||1.0000
73843174|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 7±1||||1.0000
73843175|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 7±1||||1.0000
73843176|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 7±1||||1.0000
73843177|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 7±1||||1.0000
73843178|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 7±1||||1.0000
73843179|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 7±1||||1.0000
73843180|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 7±1||||1.0000
73843181|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 7±1||||1.0000
73843182|NCT02507934|147233899|SUPERIORITY|||||||0.2429|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 14±1||||0.2429
73843183|NCT02507934|147233899|SUPERIORITY|||||||0.5707|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 14±1||||0.5707
73843184|NCT02507934|147233899|SUPERIORITY|||||||0.0092|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 14±1||||0.0092
73843185|NCT02507934|147233899|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 14±1||||0.0039
73843186|NCT02507934|147233899|SUPERIORITY|||||||0.2882|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 14±1||||0.2882
73843187|NCT02507934|147233899|SUPERIORITY|||||||0.4017|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 14±1||||0.4017
73843188|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 14±1||||1.0000
73843189|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 14±1||||1.0000
73843190|NCT02507934|147233899|SUPERIORITY|||||||0.0731|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 14±1||||0.0731
73843191|NCT02507934|147233899|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 14±1||||0.0020
73843192|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 14±1||||1.0000
73843193|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 14±1||||1.0000
73843194|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 14±1||||1.0000
73843195|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 14±1||||1.0000
73843196|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 14±1||||1.0000
73843197|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 14±1||||1.0000
73843198|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 14±1||||1.0000
73843199|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 14±1||||1.0000
73843200|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 14±1||||1.0000
73843201|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 14±1||||1.0000
73843202|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 14±1||||1.0000
73843203|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 14±1||||1.0000
73843204|NCT02507934|147233899|SUPERIORITY|||||||0.1376|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 21±1||||0.1376
73843205|NCT02507934|147233899|SUPERIORITY|||||||0.3252|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 21±1||||0.3252
73843206|NCT02507934|147233899|SUPERIORITY|||||||0.0111|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1||||0.0111
73843207|NCT02507934|147233899|SUPERIORITY|||||||0.0049|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1||||0.0049
73843208|NCT02507934|147233899|SUPERIORITY|||||||0.1178|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 21±1||||0.1178
73843209|NCT02507934|147233899|SUPERIORITY|||||||0.9042|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 21±1||||0.9042
73843210|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 21±1||||1.0000
73843211|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 21±1||||1.0000
73843212|NCT02507934|147233899|SUPERIORITY|||||||0.0253|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 21±1||||0.0253
73843213|NCT02507934|147233899|SUPERIORITY|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 21±1||||0.0016
73843214|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 21±1||||1.0000
73959827|NCT01049503|147454835|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by One-way ANOVA after logarithmic transformation and Tukey's test."||||<0.05
73959828|NCT01049503|147454836|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from fluorescence loss were evaluated by Kruskal-Wallis and Dunn's tests.||||<0.05
73959829|NCT01049503|147454837|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from lesion area were evaluated by ANOVA after logarithmic transformation and Tukey's test.||||<0.05
73843215|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 21±1||||1.0000
73843216|NCT02507934|147233899|SUPERIORITY|||||||0.3165|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 21±1||||0.3165
73843217|NCT02507934|147233899|SUPERIORITY|||||||0.3165|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 21±1||||0.3165
73843218|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 21±1||||1.0000
73843219|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 21±1||||1.0000
73843220|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 21±1||||1.0000
73843221|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 21±1||||1.0000
73843222|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 21±1||||1.0000
73843223|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 21±1||||1.0000
73843224|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 21±1||||1.0000
73843225|NCT02507934|147233899|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 21±1||||1.0000
73843226|NCT02507934|147233900|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.0599|TWO_SIDED|95.0|-0.05|2.29|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 7±1||2.29|-0.05|0.0599
73843227|NCT02507934|147233900|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.3969|TWO_SIDED|95.0|-0.68|1.66|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye - Day 7±1||1.66|-0.68|0.3969
73843228|NCT02507934|147233900|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.7225|TWO_SIDED|95.0|-1.29|1.84|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 14±1||1.84|-1.29|0.7225
73843229|NCT02507934|147233900|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.269|TWO_SIDED|95.0|-2.14|0.62|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye - Day 14±1||0.62|-2.14|0.2690
73843230|NCT02507934|147233900|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.2344|TWO_SIDED|95.0|-0.53|2.1|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 21±1||2.10|-0.53|0.2344
73843231|NCT02507934|147233900|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.5953|TWO_SIDED|95.0|-1.3|2.24|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye||2.24|-1.30|0.5953
73843232|NCT02507934|147233901|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.2193|TWO_SIDED|95.0|-0.54|2.11|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 7||2.11|-0.54|0.2193
73843233|NCT02507934|147233901|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.0024|TWO_SIDED|95.0|0.51|2.18|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 8||2.18|0.51|0.0024
73843234|NCT02507934|147233901|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.425|TWO_SIDED|95.0|-0.49|1.14|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 9||1.14|-0.49|0.4250
73843235|NCT02507934|147233901|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.1275|TWO_SIDED|95.0|-0.17|1.29|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 10||1.29|-0.17|0.1275
73843236|NCT02507934|147233901|SUPERIORITY||Mean Difference (Final Values)|0.66||||0.0844|TWO_SIDED|95.0|-0.09|1.42|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 11||1.42|-0.09|0.0844
73843237|NCT02507934|147233901|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.0238|TWO_SIDED|95.0|0.12|1.6|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 12||1.60|0.12|0.0238
73843238|NCT02507934|147233901|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.0369|TWO_SIDED|95.0|0.05|1.61|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 13||1.61|0.05|0.0369
73843239|NCT02507934|147233901|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.3496|TWO_SIDED|95.0|-0.61|1.64|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 14||1.64|-0.61|0.3496
73843240|NCT03331354|147233904|SUPERIORITY||Cox Proportional Hazard|1.87|||=|0.016|TWO_SIDED||||||Chi-squared|||||||=.016
73959830|NCT01049503|147454838|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
73959831|NCT00726596|147454839|SUPERIORITY|||||||0.6789|||||||t-test, 1 sided|||||||.6789
73959832|NCT02974634|147454844|SUPERIORITY||Slope|1.04|STANDARD_ERROR_OF_MEAN|2.32||0.06|TWO_SIDED|95.0|-3.5|5.6||Comparison of intervention and usual care at 6 month follow up|t-test, 2 sided||Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model|||5.6|-3.5|0.06
73959833|NCT02974634|147454845|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.29||0.68|TWO_SIDED|95.0|-0.24|0.91||Comparison of intervention and usual care at 6 month follow up|t-test, 2 sided||Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model|||0.91|-0.24|0.68
73843241|NCT03331354|147233905|SUPERIORITY|||||||0.008|||||||ANCOVA|Initial interview scores were used as control in the ANCOVA||||||.008
73843242|NCT03331354|147233906|SUPERIORITY|||||||0.99|||||||ANCOVA|Change in confidence was evaluated using time one as a covariate.||||||.99
73843243|NCT03331354|147233906|SUPERIORITY|||||||0.99|||||||ANCOVA|Interview scores at enrollment were used as a covariate||||||.99
73843244|NCT03331354|147233907|OTHER||||||<|0.001|||||||Pearson Correlation|||This post-hoc analysis was performed on only the COMPASS group to determine the association between percent of the online system completed and change in interview scores||||<.001
73843245|NCT00928668|147233924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.157|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|0.657|1.657|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||1.657|0.657|<0.0001
73843246|NCT00928668|147233924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.711|STANDARD_ERROR_OF_MEAN|0.255|<|0.0001|TWO_SIDED|95.0|1.205|2.217|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.217|1.205|<0.0001
73843247|NCT00928668|147233924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.443|STANDARD_ERROR_OF_MEAN|0.248|<|0.0001|TWO_SIDED|95.0|1.952|2.935|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||2.935|1.952|<0.0001
73843248|NCT00928668|147233924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.984|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|2.486|3.483|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||3.483|2.486|<0.0001
73843249|NCT00928668|147233925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.139|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|1.645|2.633|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.633|1.645|<0.0001
73843250|NCT00928668|147233925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.636|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|2.135|3.136|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||3.136|2.135|<0.0001
73843251|NCT00928668|147233925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|3.074|4.046|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||4.046|3.074|<0.0001
73843252|NCT00928668|147233925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.224|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|3.731|4.717|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.717|3.731|<0.0001
73959834|NCT02962674|147454856|SUPERIORITY|||||||0.004|||||||t-test, 1 sided|||"The null and alternative hypotheses associated with this objective was written as:~H0: μ ΔIPSS ≤ 6.5 points HA: μ ΔIPSS \> 6.5 points where μ ΔIPSS was the true underlying value of mean ΔIPSS following a treatment at the 3-month follow-up visit and 6.5 points was an objective performance goal (OPG). The objective was met at a given time point by rejecting the null hypothesis in a one-sided t-test at the 5% significance level."||||0.004
73959835|NCT01124188|147454871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.63|1.8||||||||1.80|0.63|
73959836|NCT01124188|147454872|SUPERIORITY_OR_OTHER|||||||0.49|||||||Mixed Models Analysis|||||||.49
73959837|NCT01124188|147454873|SUPERIORITY_OR_OTHER|||||||0.88|||||||Mixed Models Analysis|||||||0.88
73959838|NCT01324453|147454884|SUPERIORITY|||||||0.9|||||||Kruskal-Wallis|||||||0.90
73843253|NCT00928668|147233926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.025|STANDARD_ERROR_OF_MEAN|0.296|<|0.0001|TWO_SIDED|95.0|1.437|2.613|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.613|1.437|<0.0001
73843254|NCT00928668|147233926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|1.785|2.975|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.975|1.785|<0.0001
73843255|NCT00928668|147233926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.549|STANDARD_ERROR_OF_MEAN|0.292|<|0.0001|TWO_SIDED|95.0|2.971|4.127|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||4.127|2.971|<0.0001
73843256|NCT00928668|147233926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.208|STANDARD_ERROR_OF_MEAN|0.296|<|0.0001|TWO_SIDED|95.0|3.622|4.794|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.794|3.622|<0.0001
73843257|NCT00928668|147233927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.907|STANDARD_ERROR_OF_MEAN|0.295|<|0.0001|TWO_SIDED|95.0|1.322|2.492|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.492|1.322|<0.0001
73843258|NCT00928668|147233927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.474|STANDARD_ERROR_OF_MEAN|0.299|<|0.0001|TWO_SIDED|95.0|1.822|3.066|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||3.066|1.822|<0.0001
73843259|NCT00928668|147233927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.327|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|2.752|3.902|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||3.902|2.752|<0.0001
73843260|NCT00928668|147233927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.22|STANDARD_ERROR_OF_MEAN|0.294|<|0.0001|TWO_SIDED|95.0|3.637|4.803|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.803|3.637|<0.0001
73843261|NCT00928668|147233928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.229|STANDARD_ERROR_OF_MEAN|0.271|<|0.0001|TWO_SIDED|95.0|0.692|1.766|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||1.766|0.692|<0.0001
73843262|NCT00928668|147233928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.825|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|1.281|2.369|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.369|1.281|<0.0001
73959839|NCT01324453|147454885|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||||||0.81
73959840|NCT01324453|147454886|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
73843263|NCT00928668|147233928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.114|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|1.578|2.65|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||2.650|1.578|<0.0001
73959841|NCT01324453|147454887|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
73843264|NCT00928668|147233928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.645|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|2.11|3.181|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||3.181|2.110|<0.0001
73843265|NCT01838226|147233931|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5|TWO_SIDED|95.0|-1.3|2.8|||Mixed Models Analysis|||||2.8|-1.3|0.50
73843266|NCT01838226|147233932|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-1.3|3.1|||Mixed Models Analysis|||||3.1|-1.3|
73843267|NCT01838226|147233933|SUPERIORITY||Mean Difference (Net)|-2.6|||||TWO_SIDED|95.0|-4.9|-0.2||||||||-0.2|-4.9|
73843268|NCT03232567|147233953|SUPERIORITY|||||||0.2451|||||||Fisher Exact|||||||0.2451
73843269|NCT03232567|147233953|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
73843270|NCT03232567|147233953|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
73843271|NCT03232567|147233954|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||||||0.4828
73843272|NCT03232567|147233954|SUPERIORITY|||||||0.0996|||||||Fisher Exact|||||||0.0996
73843273|NCT03232567|147233954|SUPERIORITY|||||||0.0421|||||||Fisher Exact|||||||0.0421
73843274|NCT03232567|147233956|SUPERIORITY|||||||0.0169|||||||Fisher Exact|||NasoVAX low dose vs placebo||||0.0169
73843275|NCT03232567|147233956|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||NasoVAX medium dose vs placebo||||0.0063
73843276|NCT03232567|147233956|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||NasoVAX high dose vs placebo||||<0.0001
73843277|NCT02284893|147234023|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1001||0.0008|||||||Mixed Models Analysis|||||||0.0008
73843278|NCT02284893|147234024|SUPERIORITY||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|4.175||0.0034|||||||Regression, Logistic|the analysis was by Zhang et.al. method with adjustment for baseline A1c.The measure of interest is NOT odds ratio but Risk Difference.||||||0.0034
73843279|NCT02284893|147234025|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.2891||0.0001|||||||Mixed Models Analysis|||||||0.0001
73843280|NCT02284893|147234026|SUPERIORITY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|3.682||0.0001|||||||Mixed Models Analysis|||||||0.0001
73959842|NCT01324453|147454888|SUPERIORITY|||||||0.86|||||||Kruskal-Wallis|||||||0.86
73959843|NCT01324453|147454889|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.00
73959844|NCT01324453|147454890|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||0.58
73959845|NCT01324453|147454891|SUPERIORITY|||||||0.77|||||||Kruskal-Wallis|||||||0.77
74022435|NCT01431287|147597109|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.434|STANDARD_ERROR_OF_MEAN|0.137||0.0015|TWO_SIDED|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.703|0.166|0.0015
74084280|NCT01525628|147721696|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|96.06|STANDARD_DEVIATION|14.2||0.0015|TWO_SIDED|90.0|87.77|105.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||105.13|87.77|0.0015
73843281|NCT02908178|147234083|OTHER||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|99.0|1.18|1.63||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any complication in the Aim 1 matched cohort.||1.63|1.18|<.001
73843282|NCT02908178|147234083|OTHER||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|99.0|2.27|8.75||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema in the Aim 1 matched cohort.||8.75|2.27|<.001
73843283|NCT02908178|147234083|OTHER||Odds Ratio (OR)|1.24|||<|0.001|TWO_SIDED|99.0|1.0|1.54||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and wound infection in the Aim 1 matched cohort.||1.54|1.00|<.001
73843284|NCT02908178|147234083|OTHER||Odds Ratio (OR)|1.4|||<|0.001|TWO_SIDED|99.0|1.03|1.91||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 1 matched cohort.||1.91|1.03|<.001
73843285|NCT02908178|147234083|OTHER||Odds Ratio (OR)|1.31||||0.003|TWO_SIDED|99.0|1.04|1.65||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 1 matched cohort.||1.65|1.04|.003
73843286|NCT02908178|147234084|OTHER||||||<|0.001||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of mastectomy within 6 months of DCIS diagnosis.||||<.001
73843287|NCT02908178|147234085|OTHER|||||||0.48||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of radiation therapy within 9 months of DCIS diagnosis.||||.48
73843288|NCT02908178|147234086|OTHER||Hazard Ratio (HR)|0.88|||<|0.001|TWO_SIDED|99.0|0.73|1.05||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and overall mortality in the Aim 2 matched cohort.||1.05|0.73|<.001
73843289|NCT02908178|147234087|OTHER||Hazard Ratio (HR)|1.09||||0.207|TWO_SIDED|99.0|1.0|1.2||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any side effects in the matched Aim 2 cohort.||1.20|1.00|0.207
73843290|NCT02908178|147234087|OTHER||Hazard Ratio (HR)|1.53|||<|0.001|TWO_SIDED|99.0|1.12|2.11||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema related complications in the Aim 2 matched cohort.||2.11|1.12|<.001
73959846|NCT01930045|147454942|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|0.4||||0.507|TWO_SIDED|90.0|0.31|0.52|||Hochberg step-up procedure||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs geometric mean ratio (GMR) is not less than 0.4||0.52|0.31|0.507
73863224|NCT03344640|147272632|SUPERIORITY||Difference and 90% CI versus placebo|0.01||||0.613|TWO_SIDED|90.0|-0.03|0.06|||LS Mean|LS mean change from baseline in EQ-5D-5L Index score||Statistical analysis results of of EQ-5D-5L Index score at day 99 (PD Analysis Set)||0.06|-0.03|0.613
73959847|NCT01930045|147454942|SUPERIORITY_OR_OTHER||GMR|0.38||||0.624|TWO_SIDED|90.0|0.3|0.49|||Hochberg step-up procedure||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.49|0.30|0.624
73959848|NCT01930045|147454943|SUPERIORITY_OR_OTHER||GMR|0.81|||||TWO_SIDED|90.0|0.63|1.05|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.05|0.63|
73959849|NCT01930045|147454943|SUPERIORITY_OR_OTHER||GMR|0.68|||||TWO_SIDED|90.0|0.5|0.92|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||0.92|0.50|
74084281|NCT01525628|147721696|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|85.41|STANDARD_DEVIATION|17.2||0.1617|TWO_SIDED|90.0|76.32|95.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||95.57|76.32|0.1617
73843291|NCT02908178|147234087|OTHER||Hazard Ratio (HR)|0.98||||0.113|TWO_SIDED|99.0|0.87|1.1||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any infection in the Aim 2 matched cohort.||1.10|0.87|0.113
73843292|NCT02908178|147234087|OTHER||Hazard Ratio (HR)|1.21||||0.01|TWO_SIDED|99.0|0.93|1.58||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 2 matched cohort.||1.58|0.93|0.010
73843293|NCT02908178|147234087|OTHER||Hazard Ratio (HR)|1.1||||0.029|TWO_SIDED|99.0|0.98|1.25||P-value is unadjusted. Threshold for statistical significance is 0.01|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 2 matched cohort.||1.25|0.98|0.029
73843294|NCT02908178|147234088|OTHER||Hazard Ratio (HR)|1.13||||0.861|TWO_SIDED|99.0|0.54|2.35||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between between use of sentinel lymph node biopsy (SLNB) and breast cancer specific mortality.||2.35|0.54|0.861
73843295|NCT02908178|147234089|OTHER||Hazard Ratio (HR)|1.03||||0.603|TWO_SIDED|99.0|0.71|1.51||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and ipsilateral invasive breast cancer occurrence for the Aim 2 matched cohort.||1.51|0.71|0.603
73843296|NCT02908178|147234090|OTHER||Hazard Ratio (HR)|1.17||||0.62|TWO_SIDED|99.0|0.81|1.69||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and treated recurrence in the Aim 2 matched cohort.||1.69|0.81|0.620
73843297|NCT01506726|147234100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.23|TWO_SIDED|95.0|-2.08|0.2|||Wilcoxon (Mann-Whitney)|Wilcoxon two sample test||||0.20|-2.08|0.230
73843298|NCT01506726|147234101|SUPERIORITY_OR_OTHER|||||||0.347|TWO_SIDED||||||t-test, 2 sided|||||||0.347
73843299|NCT01506726|147234102|SUPERIORITY_OR_OTHER|||||||0.857|TWO_SIDED|||||Correlation between change in IL-6 and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.857
73843300|NCT01506726|147234102|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED|||||Correlation between change in IL-6 and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.706
73843301|NCT01506726|147234102|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||Correlation between change in TNF and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.014
73843302|NCT01506726|147234102|SUPERIORITY_OR_OTHER|||||||0.136|TWO_SIDED|||||Correlation between change in TNF and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.136
73843303|NCT01506726|147234102|SUPERIORITY_OR_OTHER|||||||0.803|TWO_SIDED|||||Correlation between change in CRP and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.803
73843304|NCT01506726|147234102|SUPERIORITY_OR_OTHER|||||||0.894|TWO_SIDED|||||Correlation between change in CRP and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.894
73843305|NCT01506726|147234103|SUPERIORITY_OR_OTHER|||||||0.143|TWO_SIDED|||||P value comparing change in IL6 between treatment groups.|t-test, 2 sided|||||||0.143
73843306|NCT01506726|147234103|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED|||||P value comparing the change in TNF between treatment groups.|t-test, 2 sided|||||||0.257
73843307|NCT01506726|147234104|SUPERIORITY_OR_OTHER|||||||0.535|TWO_SIDED|||||P-value comparing the change in EPO between treatment groups.|t-test, 2 sided|||||||0.535
73843308|NCT01506726|147234105|SUPERIORITY_OR_OTHER|||||||0.232|TWO_SIDED||||||t-test, 2 sided|||||||0.232
73843309|NCT01506726|147234106|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED||||||t-test, 2 sided|||||||0.076
73843310|NCT01506726|147234107|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
73843311|NCT01506726|147234108|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED||||||t-test, 2 sided|||||||0.187
73843312|NCT01506726|147234109|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||t-test, 2 sided|||||||0.193
73843313|NCT01506726|147234110|SUPERIORITY_OR_OTHER|||||||0.619|TWO_SIDED||||||t-test, 2 sided|||||||0.619
73843314|NCT01506726|147234111|SUPERIORITY_OR_OTHER|||||||0.642|TWO_SIDED||||||t-test, 2 sided|||||||0.642
73843315|NCT01506726|147234112|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||t-test, 2 sided|||||||0.42
73843316|NCT01506726|147234113|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
73843317|NCT01506726|147234114|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Chi-squared|||||||0.375
73843318|NCT01506726|147234116|SUPERIORITY_OR_OTHER|||||||0.398|||||||t-test, 2 sided|||||||0.398
73843319|NCT01506726|147234117|SUPERIORITY_OR_OTHER|||||||0.412|||||||t-test, 2 sided|||||||0.412
73843320|NCT03126630|147234120|EQUIVALENCE|The null hypothesis that there are no differences between the classes in the population. The purpose of the test is to evaluate how likely the observed frequencies would be assuming the null hypothesis is true.||||||0.27541|||||||Chi-squared|||||||0.27541
73843321|NCT03126630|147234123|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.1936|TWO_SIDED|95.0|0.0||Not enough events||Log Rank||||||0.0|0.1936
73843322|NCT03126630|147234124|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.1952|TWO_SIDED|95.0|0.73|4.51|||Log Rank|||||4.51|0.73|0.1952
73843323|NCT04116489|147234144|SUPERIORITY|||||||0.5272|||||||Regression, Linear|||||||.5272
73843324|NCT04116489|147234145|SUPERIORITY|||||||0.1657|||||||Regression, Linear|||||||.1657
73843325|NCT04116489|147234146|SUPERIORITY|||||||0.2437|||||||Regression, Linear|||||||.2437
73843326|NCT04116489|147234147|OTHER|||||||0.0373|||||||Regression, Linear|||||||.0373
73843327|NCT01877278|147234212|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
74022436|NCT01431287|147597109|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.419|STANDARD_ERROR_OF_MEAN|0.137||0.0022|TWO_SIDED|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.687|0.151|0.0022
73843328|NCT01877278|147234212|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
73843329|NCT01877278|147234213|SUPERIORITY_OR_OTHER||||||=|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||=0.0001
73843330|NCT01877278|147234213|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
73843331|NCT04603560|147234214|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.54|1.66|||||The odds ratio represents Social Norming vs Control.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size||1.66|0.54|
73843332|NCT04603560|147234214|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.72|2.29|||||The odds ratio represents Pharmacist E-Detailing vs Control.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size||2.29|0.72|
73843333|NCT04603560|147234214|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.74|2.56|||||The odds ratio represents Pharmacist e-detailing vs Social Norming.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size.||2.56|0.74|
73843334|NCT02757768|147234253|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.039|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.02|-0.76|0.039
73843335|NCT02757768|147234254|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.18||0.558|TWO_SIDED|95.0|-0.46|0.25|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.25|-0.46|0.558
73843336|NCT02757768|147234254|SUPERIORITY||LS Mean of Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.89|-0.14|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.14|-0.89|0.007
73843337|NCT02757768|147234254|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.041|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.02|-0.76|0.041
73843338|NCT02757768|147234255|SUPERIORITY||LS Mean of Difference|3.87|STANDARD_ERROR_OF_MEAN|2.8||0.167|TWO_SIDED|95.0|-1.63|9.37|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||9.37|-1.63|0.167
73843339|NCT02757768|147234255|SUPERIORITY||LS Mean of Difference|6.29|STANDARD_ERROR_OF_MEAN|3.28||0.056|TWO_SIDED|95.0|-0.15|12.73|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||12.73|-0.15|0.056
74022437|NCT01431287|147597109|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.227|STANDARD_ERROR_OF_MEAN|0.137||0.0966|TWO_SIDED|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.495|-0.041|0.0966
73843340|NCT02757768|147234255|SUPERIORITY||LS Mean of Difference|8.99|STANDARD_ERROR_OF_MEAN|3.58||0.012|TWO_SIDED|95.0|1.97|16.01|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||16.01|1.97|0.012
73843341|NCT02757768|147234255|SUPERIORITY||LS Mean of Difference|9.25|STANDARD_ERROR_OF_MEAN|3.43||0.007|TWO_SIDED|95.0|2.53|15.98|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||15.98|2.53|0.007
73843342|NCT02757768|147234256|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.747|TWO_SIDED|95.0|-0.63|0.38|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.38|-0.63|0.747
73843343|NCT02757768|147234256|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.32||0.393|TWO_SIDED|95.0|-0.72|0.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.54|-0.72|0.393
73843344|NCT02757768|147234256|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.32||0.672|TWO_SIDED|95.0|-0.87|0.38|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.38|-0.87|0.672
73843345|NCT02757768|147234256|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.64|TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.30|-0.90|0.640
73843346|NCT02757768|147234257|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.21||0.222|TWO_SIDED|95.0|-0.68|0.16|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.16|-0.68|0.222
73843347|NCT02757768|147234257|SUPERIORITY||LS Mean of Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.24||0.003|TWO_SIDED|95.0|-1.18|-0.24|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.24|-1.18|0.003
73843348|NCT02757768|147234257|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.13|-0.17|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.17|-1.13|0.008
73843349|NCT02757768|147234257|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.13|-0.21|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.21|-1.13|0.004
73843350|NCT02757768|147234258|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.723|TWO_SIDED|95.0|-0.6|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.9|-0.6|0.723
73843351|NCT02757768|147234258|SUPERIORITY||LS Mean of Difference|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.7|TWO_SIDED|95.0|-0.7|1.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.0|-0.7|0.700
73843352|NCT02757768|147234258|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.4|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.5|-1.3|0.400
73959850|NCT01930045|147454944|SUPERIORITY_OR_OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.55|1.1|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.10|0.55|
73959851|NCT01930045|147454944|SUPERIORITY_OR_OTHER||GMR|0.7|||||TWO_SIDED|90.0|0.48|1.04|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.04|0.48|
73843353|NCT02757768|147234258|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.812|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.8|-1.0|0.812
73843354|NCT02757768|147234259|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.121|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.9|-0.1|0.121
73959852|NCT01930045|147454945|SUPERIORITY_OR_OTHER||GMR|0.5|||||TWO_SIDED|90.0|0.39|0.65|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.65|0.39|
73959853|NCT01930045|147454945|SUPERIORITY_OR_OTHER||GMR|0.51|||||TWO_SIDED|90.0|0.4|0.64|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.64|0.40|
73959854|NCT01930045|147454946|SUPERIORITY_OR_OTHER||GMR|0.87|||||TWO_SIDED|90.0|0.64|1.18|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.18|0.64|
73959855|NCT01930045|147454946|SUPERIORITY_OR_OTHER||GMR|0.89|||||TWO_SIDED|90.0|0.64|1.22|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.22|0.64|
73959856|NCT01930045|147454947|SUPERIORITY_OR_OTHER||GMR|0.9|||||TWO_SIDED|90.0|0.58|1.4|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.40|0.58|
73843355|NCT02757768|147234259|SUPERIORITY||LS Mean of Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.241|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.8|-0.2|0.241
73843356|NCT02757768|147234259|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.843|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.5|-0.6|0.843
73843357|NCT02757768|147234259|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.679|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.7|-0.4|0.679
73843358|NCT02757768|147234260|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.175|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.7|0.175
73843359|NCT02757768|147234260|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.43|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.2|-0.6|0.430
73843360|NCT02757768|147234260|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.141|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.8|0.141
73843361|NCT02757768|147234260|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.288|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.2|-0.7|0.288
73843362|NCT02757768|147234261|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.3|0.128
73843363|NCT02757768|147234261|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.054|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.4|0.054
73843364|NCT02757768|147234261|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.079|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.4|0.079
73843365|NCT02757768|147234261|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.148|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.4|0.148
73843366|NCT02757768|147234262|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.25||0.66|TWO_SIDED|95.0|-0.61|0.39|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.39|-0.61|0.660
73843367|NCT02757768|147234262|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.32||0.767|TWO_SIDED|95.0|-0.72|0.53|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.53|-0.72|0.767
73843368|NCT02757768|147234262|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.372|TWO_SIDED|95.0|-0.89|0.34|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.34|-0.89|0.372
73843369|NCT02757768|147234262|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.3||0.272|TWO_SIDED|95.0|-0.92|0.26|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.26|-0.92|0.272
73843370|NCT02757768|147234263|SUPERIORITY||LS Mean of Difference|-1.75|STANDARD_ERROR_OF_MEAN|1.3||0.179|TWO_SIDED|95.0|-4.29|0.8|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.80|-4.29|0.179
73843371|NCT02757768|147234263|SUPERIORITY||LS Mean of Difference|-3.84|STANDARD_ERROR_OF_MEAN|1.41||0.006|TWO_SIDED|95.0|-6.6|-1.08|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-1.08|-6.60|0.006
73863225|NCT03344640|147272632|SUPERIORITY||Difference and 90% CI versus placebo|0.02||||0.74|TWO_SIDED|90.0|-0.04|0.06|||LS Mean|LS mean change from baseline in EQ-5D-5L Index score||Statistical analysis results of of EQ-5D-5L Index score at End of Study (PD Analysis Set)||0.06|-0.04|0.740
73843372|NCT02757768|147234263|SUPERIORITY||LS Mean of Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.51||0.055|TWO_SIDED|95.0|-5.86|0.06|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.06|-5.86|0.055
73843373|NCT02757768|147234263|SUPERIORITY||LS Mean of Difference|-2.11|STANDARD_ERROR_OF_MEAN|1.48||0.154|TWO_SIDED|95.0|-5.02|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.80|-5.02|0.154
73843374|NCT02757768|147234264|SUPERIORITY||LS Mean of Difference|-1.35|STANDARD_ERROR_OF_MEAN|1.13||0.233|TWO_SIDED|95.0|-3.57|0.87|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.87|-3.57|0.233
73843375|NCT02757768|147234264|SUPERIORITY||LS Mean of Difference|0.46|STANDARD_ERROR_OF_MEAN|1.2||0.698|TWO_SIDED|95.0|-1.89|2.82|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.82|-1.89|0.698
73843376|NCT02757768|147234264|SUPERIORITY||LS Mean of Difference|0.89|STANDARD_ERROR_OF_MEAN|1.28||0.486|TWO_SIDED|95.0|-1.62|3.4|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.40|-1.62|0.486
73843377|NCT02757768|147234264|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|1.26||0.968|TWO_SIDED|95.0|-2.52|2.42|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.42|-2.52|0.968
73843378|NCT02757768|147234265|SUPERIORITY||LS Mean of Difference|-1.89|STANDARD_ERROR_OF_MEAN|1.36||0.165|TWO_SIDED|95.0|-4.56|0.78|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.78|-4.56|0.165
73843379|NCT02757768|147234265|SUPERIORITY||LS Mean of Difference|0.76|STANDARD_ERROR_OF_MEAN|1.41||0.592|TWO_SIDED|95.0|-2.02|3.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.54|-2.02|0.592
73843380|NCT02757768|147234265|SUPERIORITY||LS Mean of Difference|0.9|STANDARD_ERROR_OF_MEAN|1.54||0.559|TWO_SIDED|95.0|-2.12|3.92|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.92|-2.12|0.559
73843381|NCT02757768|147234265|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|1.51||0.985|TWO_SIDED|95.0|-2.94|3.0|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.00|-2.94|0.985
73843382|NCT02757768|147234266|SUPERIORITY||LS Mean of Difference|-1.82|STANDARD_ERROR_OF_MEAN|1.29||0.161|TWO_SIDED|95.0|-4.35|0.72|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.72|-4.35|0.161
73843383|NCT02757768|147234266|SUPERIORITY||LS Mean of Difference|0.35|STANDARD_ERROR_OF_MEAN|1.38||0.798|TWO_SIDED|95.0|-2.36|3.07|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.07|-2.36|0.798
73843384|NCT02757768|147234266|SUPERIORITY||LS Mean of Difference|1.17|STANDARD_ERROR_OF_MEAN|1.42||0.408|TWO_SIDED|95.0|-1.61|3.95|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.95|-1.61|0.408
73843385|NCT02757768|147234266|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|1.39||0.919|TWO_SIDED|95.0|-2.6|2.88|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.88|-2.60|0.919
73843386|NCT02757768|147234267|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|1.49||0.99|TWO_SIDED|95.0|-2.94|2.91|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.91|-2.94|0.990
73843387|NCT02757768|147234267|SUPERIORITY||LS Mean of Difference|0.92|STANDARD_ERROR_OF_MEAN|1.55||0.554|TWO_SIDED|95.0|-2.12|3.96|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.96|-2.12|0.554
73863226|NCT03344640|147272633|SUPERIORITY||Difference and 90% CI versus placebo|-5.55||||0.281|TWO_SIDED|90.0|-14.07|2.97|||LS Mean|LS MMean CFB (90% CI)||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99||2.97|-14.07|0.281
73959857|NCT01930045|147454947|SUPERIORITY_OR_OTHER||GMR|0.9|||||TWO_SIDED|90.0|0.58|1.41|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.41|0.58|
73843388|NCT02757768|147234267|SUPERIORITY||LS Mean of Difference|1.53|STANDARD_ERROR_OF_MEAN|1.63||0.348|TWO_SIDED|95.0|-1.67|4.73|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||4.73|-1.67|0.348
73843389|NCT02757768|147234267|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|1.6||0.876|TWO_SIDED|95.0|-2.89|3.38|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.38|-2.89|0.876
73843390|NCT02757768|147234268|SUPERIORITY||LS Mean of Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.05||0.293|TWO_SIDED|95.0|-3.16|0.95|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.95|-3.16|0.293
73843391|NCT02757768|147234268|SUPERIORITY||LS Mean of Difference|-0.32|STANDARD_ERROR_OF_MEAN|1.12||0.773|TWO_SIDED|95.0|-2.52|1.87|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.87|-2.52|0.773
73843392|NCT02757768|147234268|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|1.12||0.94|TWO_SIDED|95.0|-2.28|2.11|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.11|-2.28|0.940
73843393|NCT02757768|147234268|SUPERIORITY||LS Mean of Difference|-0.71|STANDARD_ERROR_OF_MEAN|1.1||0.516|TWO_SIDED|95.0|-2.86|1.44|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.44|-2.86|0.516
73843394|NCT02757768|147234269|SUPERIORITY|||||||0.4591|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 4 Placebo vs. Mirabegron.||||0.4591
73843395|NCT02757768|147234269|SUPERIORITY|||||||0.4073|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 8 Placebo vs. Mirabegron.||||0.4073
73843396|NCT02757768|147234269|SUPERIORITY|||||||0.774|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 12 Placebo vs. Mirabegron.||||0.7740
73843397|NCT02757768|147234269|SUPERIORITY|||||||0.5121|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||EoT Placebo vs. Mirabegron.||||0.5121
73843398|NCT02757768|147234270|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.223|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.223
73843399|NCT02757768|147234270|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.598|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.598
73843400|NCT02757768|147234270|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.312|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.3|0.312
73843401|NCT02757768|147234270|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.525|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.525
73843402|NCT02757768|147234272|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.226|TWO_SIDED|95.0|-0.08|0.34|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.34|-0.08|0.226
73843403|NCT02757768|147234272|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.11||0.501|TWO_SIDED|95.0|-0.14|0.28|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.28|-0.14|0.501
73843404|NCT02757768|147234272|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.984|TWO_SIDED|95.0|-0.22|0.23|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.23|-0.22|0.984
73843405|NCT02757768|147234272|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.11||0.78|TWO_SIDED|95.0|-0.18|0.24|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.24|-0.18|0.780
73843406|NCT02757768|147234273|SUPERIORITY||LS Mean of Difference|3.1|STANDARD_ERROR_OF_MEAN|1.9||0.107|TWO_SIDED|95.0|-0.7|6.8|||ANCOVA|||Week 4 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.8|-0.7|0.107
73843407|NCT02757768|147234273|SUPERIORITY||LS Mean of Difference|2.5|STANDARD_ERROR_OF_MEAN|1.9||0.19|TWO_SIDED|95.0|-1.3|6.3|||ANCOVA|||Week 8 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.3|-1.3|0.190
73843408|NCT02757768|147234273|SUPERIORITY||LS Mean of Difference|2.2|STANDARD_ERROR_OF_MEAN|2.1||0.297|TWO_SIDED|95.0|-1.9|6.3|||ANCOVA|||Week 12 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.3|-1.9|0.297
73843409|NCT02757768|147234273|SUPERIORITY||LS Mean of Difference|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.493|TWO_SIDED|95.0|-2.7|5.5|||ANCOVA|||EoT Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||5.5|-2.7|0.493
73843410|NCT01765400|147234359|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73843411|NCT00836706|147234362|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|85.2|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||120|85.2|
73843412|NCT00836706|147234363|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.7|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|88.7|
73843413|NCT00836706|147234364|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.4|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|88.4|
73843414|NCT02989857|147234365|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.54||P-value was calculated from the one-sided stratified log-rank test.|Log Rank||Hazard ratio was calculated from stratified Cox regression model with placebo as the denominator, with two-sided 95% confidence interval.|||0.54|0.25|<0.0001
73843415|NCT02989857|147234372|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.093|TWO_SIDED|95.0|0.56|1.12||P-value was calculated from the one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.|Log Rank||Hazard ratio was calculated from the stratified Cox regression model with placebo as the comparator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.|||1.12|0.56|0.093
73843416|NCT02989857|147234373|SUPERIORITY|||||||0.466||||||P-value was calculated from 1-sided Fisher exact test.|Fisher Exact|||||||0.466
73843417|NCT02989857|147234374|SUPERIORITY|||||||0.299||||||P-value was calculated from 1-sided Fisher exact test.|Fisher Exact|||||||0.299
73843418|NCT02989857|147234379|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.68||P-value was calculated from one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.|Log Rank||Hazard ratio was calculated from the stratified Cox regression model with placebo as the denominator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.|||0.68|0.33|<0.0001
73843419|NCT02989857|147234380|OTHER||Least-squares mean difference|11.0|||||TWO_SIDED|95.0|4.23|17.73||||||Cycle 2 Day 1: Physical Functioning||17.73|4.23|
73843420|NCT02989857|147234380|OTHER||Least-squares mean difference|-10.4|||||TWO_SIDED|95.0|-20.18|-0.52||||||Cycle 2 Day 1: Pain||-0.52|-20.18|
73843421|NCT02989857|147234380|OTHER||Least-squares mean difference|3.6|||||TWO_SIDED|95.0|-6.65|13.91||||||Cycle 2 Day 1: Appetite Loss||13.91|-6.65|
73843422|NCT02989857|147234380|OTHER||Least-squares mean difference|12.3|||||TWO_SIDED|95.0|3.85|20.78||||||Cycle 3 Day 1: Physical Functioning||20.78|3.85|
73843423|NCT02989857|147234380|OTHER||Least-squares mean difference|4.1|||||TWO_SIDED|95.0|-8.74|17.04||||||Cycle 3 Day 1: Pain||17.04|-8.74|
73843424|NCT02989857|147234380|OTHER||Least-squares mean difference|-3.7|||||TWO_SIDED|95.0|-17.46|10.11||||||Cycle 3 Day 1: Appetite Loss||10.11|-17.46|
73843425|NCT02989857|147234381|OTHER||Least-squares mean difference|-5.1|||||TWO_SIDED|95.0|-12.93|2.8||||||Cycle 2 Day 1: Pain||2.80|-12.93|
73843426|NCT02989857|147234381|OTHER||Least-squares mean difference|0.7|||||TWO_SIDED|95.0|-6.56|7.88||||||Cycle 2 Day 1: Appetite Loss||7.88|-6.56|
73843427|NCT02989857|147234381|OTHER||Least-squares mean difference|4.4|||||TWO_SIDED|95.0|-5.82|14.55||||||Cycle 3 Day 1: Pain||14.55|-5.82|
73843428|NCT02989857|147234381|OTHER||Least-squares mean difference|-6.1|||||TWO_SIDED|95.0|-15.34|3.12||||||Cycle 3 Day 1: Appetite Loss||3.12|-15.34|
73843429|NCT01139515|147234408|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|98.7|||||TWO_SIDED|90.0|92.17|105.7||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||105.70|92.17|
73843430|NCT01139515|147234408|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|109.48|||||TWO_SIDED|90.0|102.23|117.24||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.24|102.23|
73959858|NCT01786564|147454948|OTHER|This is cross-sectional analysis in a single group.|Regression Coefficient|-0.075||||0.13|TWO_SIDED|95.0|-0.173|0.023||Unadjusted association. A priori p value of .05 was selected for statistical significance.|Regression, Linear|||The cross-sectional association between habitual sleep duration and oral disposition index was analyzed.||.023|-.173|.13
73843431|NCT01139515|147234408|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|109.93|||||TWO_SIDED|90.0|102.65|117.72||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.72|102.65|
73843432|NCT01139515|147234409|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric means ratio|99.41|||||TWO_SIDED|90.0|92.97|106.31||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||106.31|92.97|
73843433|NCT01139515|147234409|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|110.52|||||TWO_SIDED|90.0|103.36|118.18||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.18|103.36|
73843434|NCT01139515|147234409|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|110.44|||||TWO_SIDED|90.0|103.28|118.09||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.09|103.28|
73843435|NCT01139515|147234410|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric means ratio|101.81|||||TWO_SIDED|90.0|85.97|120.58||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||120.58|85.97|
73843436|NCT01139515|147234410|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|98.57|||||TWO_SIDED|90.0|83.23|116.73||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||116.73|83.23|
73843437|NCT01139515|147234410|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|107.44|||||TWO_SIDED|90.0|90.72|127.25||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||127.25|90.72|
74084282|NCT01525628|147721696|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|73.26|STANDARD_DEVIATION|17.5||0.893|TWO_SIDED|90.0|65.03|82.54|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||82.54|65.03|0.8930
73843438|NCT02541591|147234413|SUPERIORITY||Median ratio of final values|1.37||||0.0881|TWO_SIDED|95.0|0.95|1.98|||ANOVA|due to non normality of the residuals the data were log-transformed prior to the anova|the estimated mean difference obtained using the anova on the log-transformed data was back transformed thus yielding a ratio of median values|missing data were accounted for by multiple imputation||1.98|0.95|0.0881
73843439|NCT03978598|147234414|NON_INFERIORITY|We used a 15% difference in our primary outcome for the non-inferiority margin as this is the upper end of the estimated prevalence of lactation failure in the literature and is consistent with previous studies (Neifert 2001, Gurtcheff 2011, Turok 2017).|Risk Difference (RD)|3.7|||||ONE_SIDED|95.0|-16.7|||||||To achieve 80% power with a 1-sided type 1 error of 5% utilizing the Z-test (unpooled), 62 participants would be required in each group, for a total of 124 participants. Accounting for expected loss to follow-up of 20%, we aimed to recruit 149 participants and rounded up to final recruitment goal of 150.|The risk-difference between immediate and standard placement in the modified intention-to-treat analysis (mITT) was -0.6% with a -12.8% lower limit of the 95% confidence interval. In the mITT analysis, 78.3% (54/69) and 78.9% (45/57) of participants were breastfeeding at 8 weeks in the immediate and delayed groups, respectively.||-16.7|
73843440|NCT01425814|147234489|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.259|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.219|0.298|||ANCOVA|||||0.298|0.219|<0.0001
73843441|NCT01425814|147234489|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.233|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.194|0.273|||ANCOVA|||||0.273|0.194|<0.0001
73843442|NCT01425814|147234489|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.203|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.164|0.242|||ANCOVA|||||0.242|0.164|<0.0001
73843443|NCT01425814|147234489|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.102|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.062|0.141|||ANCOVA|||||0.141|0.062|<0.0001
73843444|NCT01383005|147234526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.16||||0.001|TWO_SIDED|95.0|0.052|0.494|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'viral load change from detectable to undetectable.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'detectable to undetectable' in the last model of the Wald test.||0.494|0.052|0.001
73863227|NCT03344640|147272633|SUPERIORITY||Difference and 90% CI versus placebo|-1.49||||0.78|TWO_SIDED|90.0|-10.33|7.35|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at End of Study||7.35|-10.33|0.780
74022438|NCT01431287|147597109|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.223|STANDARD_ERROR_OF_MEAN|0.137||0.1029|TWO_SIDED|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.492|-0.045|0.1029
73843445|NCT01383005|147234526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.279||||0.072|TWO_SIDED|95.0|0.07|1.118|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'viral load change from undetectable to undetectable.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 2 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'undetectable to undetectable' in the last model of the Wald test.||1.118|0.070|0.072
73843446|NCT01383005|147234527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.996||||0.025|TWO_SIDED|95.0|0.992|0.999|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'time on LPV/r.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with time on treatment with LPV/r QD in the last model of the Wald test.||0.999|0.992|0.025
73843447|NCT00895921|147234530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.1139||0.042|TWO_SIDED|95.0|0.00943|0.47605||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||.47605|.00943|0.042
73843448|NCT00895921|147234531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.253|STANDARD_ERROR_OF_MEAN|0.224||0.269|TWO_SIDED|95.0|-0.208|0.714||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||0.714|-0.208|0.269
73843449|NCT00895921|147234532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.149||0.012|TWO_SIDED|95.0|0.095|0.705|||Chi-squared, Corrected|||Comparison of akathisia rates between the two arms.||.705|.095|0.012
73843450|NCT01358734|147234534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.789||||0.119|TWO_SIDED|95.0|0.861|3.718|||Log Rank|||||3.718|0.861|0.119
73843451|NCT01358734|147234534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.659||||0.014|TWO_SIDED|95.0|1.214|5.822|||Log Rank|||||5.822|1.214|0.014
73843452|NCT01358734|147234534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.367||||0.356|TWO_SIDED|95.0|0.704|2.653|||Log Rank|||||2.653|0.704|0.356
73843453|NCT03243084|147234550|SUPERIORITY|||||||0.319||||||Threshold for significance is \<.05.|ANOVA|||A 2x2 ANOVA was used to measure change in HF-HRV by condition (10 Hz vs sham) and session (first vs second) as within subjects variables||||.319
73843454|NCT03243084|147234552|SUPERIORITY|||||||0.0488||||||Threshold for significance is \<.05.|Wilcoxon (Mann-Whitney)|||Investigators hypothesized that active stimulation would have a greater normalized pain change using a modulation index \[(Pre-Post)/(Pre+Post)\]||||.0488
73843455|NCT02008617|147234584|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
73843456|NCT02008617|147234585|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||At Rest||||0.86
73843457|NCT02008617|147234585|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Plantar Flexion||||0.89
73843458|NCT02008617|147234586|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
73843459|NCT02008617|147234587|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
73843460|NCT02300233|147234591|SUPERIORITY||Difference in Least Squares Mean (LSM)|-70.3|||<|0.0001|TWO_SIDED|95.0|-85.4|-55.3|||ANCOVA|||||-55.3|-85.4|<0.0001
73843461|NCT02300233|147234592|SUPERIORITY||Difference in LSM|-943.0|||<|0.0001|TWO_SIDED|95.0|-1197.0|-689.0|||ANCOVA|||||-689|-1197|<0.0001
73843462|NCT02300233|147234593|SUPERIORITY||Odds Ratio (OR)|96.02|||<|0.0001|TWO_SIDED|95.0|19.71|467.79|||Regression, Logistic|||||467.79|19.71|<0.0001
73843463|NCT02300233|147234594|SUPERIORITY||Difference in LSM|56.8|||<|0.0001|TWO_SIDED|95.0|45.1|68.6|||ANCOVA|||||68.6|45.1|<0.0001
73843464|NCT02300233|147234595|SUPERIORITY||Odds Ratio (OR)|14.93||||0.0474|TWO_SIDED|95.0|1.03|215.88|||Regression, Logistic|||||215.88|1.03|0.0474
73843465|NCT04752566|147234643|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.8938|TWO_SIDED|95.0|0.45|1.97||Log Rank Test stratified by randomization strata.|Log Rank||Cox proportional hazard model stratified by randomization strata, with treatment group as the fixed effect. Firth's adjustment was applied if no event was observed in a treatment group.|||1.97|0.45|0.8938
73843466|NCT04752566|147234644|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8987|TWO_SIDED|95.0|0.27|3.17|||Regression, Logistic|||Week 8||3.17|0.27|0.8987
73843467|NCT04752566|147234644|SUPERIORITY||Odds Ratio (OR)|0.6||||0.4083|TWO_SIDED|95.0|0.18|2.02|||Regression, Logistic|||Week 24||2.02|0.18|0.4083
73843468|NCT04752566|147234645|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6739|TWO_SIDED|95.0|0.24|2.54|||Regression, Logistic|||||2.54|0.24|0.6739
73843469|NCT03773484|147234656|OTHER||Slope|-0.008|STANDARD_ERROR_OF_MEAN|0.011||0.43|TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis|||Pre post comparison for Opioid Naïve patients||0.01|-0.03|0.43
74088231|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.09|-0.47|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.09|<.0001
73843470|NCT03773484|147234656|OTHER||Slope|-0.019|STANDARD_ERROR_OF_MEAN|0.016||0.24|TWO_SIDED|95.0|-0.051|0.013|||Mixed Models Analysis|||Pre-post comparison for at-risk for long term use patients||0.013|-0.051|0.24
73843471|NCT02302222|147234684|SUPERIORITY||Risk Difference (RD)|0.113||||0.1981|TWO_SIDED|95.0|-0.016|0.243|||Fisher Exact|||||0.243|-0.016|0.1981
73843472|NCT03781570|147234708|SUPERIORITY||Mean Difference (Final Values)|-0.0544|STANDARD_ERROR_OF_MEAN|0.00517|<|0.001|TWO_SIDED|95.0|-0.0648|-0.0441|||Mixed Models Analysis|Satterthwaite's method was used to estimate degrees of freedom for the mixed effects model.||Comparing placebo vs. control for thermal pain ratings with mixed effects models controlling for the stimulus intensity and the familial structure of the data.||-0.0441|-0.0648|<0.001
73843473|NCT01107496|147234710|SUPERIORITY||Median Difference (Net)|6.0||||0.0414|TWO_SIDED|95.0|1.0|12.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||12.00|1.00|0.0414
73843474|NCT01107496|147234711|SUPERIORITY||Median Difference (Net)|3.0||||0.0803|TWO_SIDED|95.0|0.0|7.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 1 data.||7.00|0.00|0.0803
73843475|NCT01107496|147234712|SUPERIORITY||Median Difference (Net)|0.0||||0.5308|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 1 data.||1.00|-1.00|0.5308
73843476|NCT01107496|147234712|SUPERIORITY||Median Difference (Net)|-1.0||||0.2032|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 2 data.||0.00|-2.00|0.2032
73843477|NCT01107496|147234712|SUPERIORITY||Median Difference (Net)|-1.0||||0.0677|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 3 data.||0.00|-2.00|0.0677
73843478|NCT01107496|147234712|SUPERIORITY||Median Difference (Net)|-1.0||||0.0743|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 4 data.||0.00|-2.00|0.0743
73843479|NCT01107496|147234712|SUPERIORITY||Median Difference (Net)|-1.0||||0.0437|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 5 data.||0.00|-2.00|0.0437
73843480|NCT01107496|147234712|SUPERIORITY||Median Difference (Net)|-1.0||||0.1209|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||0.00|-2.00|0.1209
73959859|NCT01786564|147454948|OTHER|This is cross-sectional analysis|Regression Coefficient|0.12||||0.83|TWO_SIDED|95.0|-0.95|1.19||Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression, Linear|Unadjusted.||The cross-sectional association between habitual sleep quality (sleep percentage) and oral disposition index was analyzed.||1.19|-0.95|.83
73843481|NCT01107496|147234713|SUPERIORITY||Median Difference (Net)|1.0||||0.6022|TWO_SIDED|95.0|-4.0|6.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 2 data.||6.00|-4.00|0.6022
73843482|NCT01107496|147234713|SUPERIORITY||Median Difference (Net)|-4.0||||0.0794|TWO_SIDED|95.0|-10.0|1.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 3 data.||1.00|-10.0|0.0794
73843483|NCT01107496|147234713|SUPERIORITY||Median Difference (Net)|-6.0||||0.0747|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 4 data.||0.00|-10.0|0.0747
73843484|NCT01107496|147234713|SUPERIORITY||Median Difference (Net)|-6.5||||0.0545|TWO_SIDED|95.0|-12.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 5 data.||0.00|-12.0|0.0545
73843485|NCT01107496|147234714|SUPERIORITY||Median Difference (Net)|7.0||||0.0349|TWO_SIDED|95.0|1.0|13.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||13.00|1.00|0.0349
73843486|NCT01107496|147234715|SUPERIORITY||Median Difference (Net)|-0.5||||0.4038|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 1 data||0.00|-1.00|0.4038
73843487|NCT01107496|147234715|SUPERIORITY||Median Difference (Net)|-0.5||||0.446|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 2 data||0.00|-1.00|0.4460
73843488|NCT01107496|147234715|SUPERIORITY||Median Difference (Net)|-0.5||||0.0549|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 3 data||0.00|-1.00|0.0549
73843489|NCT01107496|147234715|SUPERIORITY||Median Difference (Net)|-0.5||||0.0759|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 4 data||0.00|-1.00|0.0759
73843490|NCT01107496|147234715|SUPERIORITY||Median Difference (Net)|-0.5||||0.0342|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 5 data||0.00|-1.00|0.0342
73843491|NCT01107496|147234715|SUPERIORITY||Median Difference (Net)|-1.0||||0.0474|TWO_SIDED||||||Wilcoxon rank-sum test|||Analysis pertains to Week 6 data||||0.0474
73843492|NCT02496000|147234732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0117|||||||Kruskal-Wallis|ANOVA model on the ranks||This outcome measure requires that the the mean differences of ORMD-0801 in each of the two arms be pooled.||||0.0117
73843493|NCT03274466|147234737|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.22||||0.0013|TWO_SIDED|95.0|0.08|0.59||Threshold for statistical significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||0.59|0.08|0.0013
73843494|NCT03274466|147234738|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.33||||0.168|TWO_SIDED|95.0|0.07|1.7||Threshold for Statistical Significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||1.70|0.07|0.1680
73843495|NCT03274466|147234739|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.34||||0.3386|TWO_SIDED|95.0|0.04|3.39||Threshold for Statistical Significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||3.39|0.04|0.3386
73843496|NCT03274466|147234740|SUPERIORITY||Odds Ratio (OR)|0.22||||0.0013|TWO_SIDED|95.0|0.08|0.59||Threshold for statistical significance: alpha = 0.048|Cochran-Mantel-Haenszel|||Sensitivity analysis of the Primary Endpoint using the Intent-To-Treat population.||0.59|0.08|0.0013
73843497|NCT02445911|147234747|OTHER||Least-squares Mean Difference|-6.78|||||TWO_SIDED|95.0|-23.75|10.18|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||10.18|-23.75|
73843498|NCT02445911|147234747|OTHER||Least-squares Mean Difference|-2.97|||||TWO_SIDED|95.0|-19.65|13.72|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||13.72|-19.65|
73843499|NCT02445911|147234747|OTHER||Least-squares Mean Difference|-5.05|||||TWO_SIDED|95.0|-21.97|11.88|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||11.88|-21.97|
73843500|NCT01649869|147234765|SUPERIORITY|||||||0.0859|||||||Generalized linear model|Generalized linear model for binary outcome based on generalized estimating equations.||||||0.0859
73843501|NCT01649869|147234766|SUPERIORITY|||||||0.7068|||||||Fisher Exact|||||||0.7068
73843502|NCT01649869|147234767|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73843503|NCT01649869|147234768|SUPERIORITY|||||||0.7068|||||||Fisher Exact|||||||0.7068
73843504|NCT01649869|147234769|SUPERIORITY|||||||0.0752|||||||Fisher Exact|||||||0.0752
73843505|NCT01649869|147234771|SUPERIORITY|||||||0.4823|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.4823
73843506|NCT01649869|147234772|SUPERIORITY|||||||0.0859|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.0859
73843507|NCT01649869|147234773|OTHER|Association of binary outcome and continuous outcome||||||0.8212|||||||Generalized linear model|For binary outcome using generalized estimating equations||||||0.8212
73843508|NCT01649869|147234774|OTHER|Association of binary outcome and continuous outcome and continuous outcome||||||0.8356|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.8356
74084283|NCT01525628|147721696|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|92.23|STANDARD_DEVIATION|10.5||0.0005|TWO_SIDED|90.0|86.67|98.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||98.13|86.67|0.0005
73843509|NCT01649869|147234775|OTHER|Association of binary outcome and continuous outcome||||||0.7961|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations||||||0.7961
73843510|NCT01649869|147234776|OTHER|Association of binary outcome and continuous outcome||||||0.8675|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.8675
73843511|NCT01649869|147234777|OTHER|Association of binary outcome and continuous outcome||||||0.9682|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.9682
73843512|NCT01649869|147234778|OTHER|Association of binary outcome and continuous outcome||||||0.6063|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.6063
73843513|NCT01649869|147234779|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
73843514|NCT01649869|147234780|SUPERIORITY|||||||0.6043|||||||Fisher Exact|||||||0.6043
73959860|NCT01786564|147454948|OTHER|This is cross-sectional analysis in a single group.|Regression Coefficient|-0.05||||0.39|TWO_SIDED|95.0|-0.166|0.66||Unadjusted association. A priori p value of .05 was selected for statistical significance.|Regression, Linear|Unadjusted||The cross-sectional association between amount of Stage 3 sleep and oral disposition index was analyzed.||0.66|-.166|.39
73843515|NCT01649869|147234781|SUPERIORITY|||||||0.6513|||||||Fisher Exact|||||||0.6513
73843516|NCT01649869|147234782|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73843517|NCT01649869|147234783|SUPERIORITY|||||||0.0659|||||||Fisher Exact|||||||0.0659
73843518|NCT01649869|147234784|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73863228|NCT03344640|147272634|SUPERIORITY||Difference and 90% CI versus placebo|-3.32||||0.489|TWO_SIDED|90.0|-11.28|4.64|||LS Mean|LS Mean change from baseline in VAS score||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99||4.64|-11.28|0.489
73863229|NCT03344640|147272634|SUPERIORITY||Difference and 90% CI versus placebo|-8.29||||0.087|TWO_SIDED|90.0|-16.26|-0.32|||LS Mean|LS Mean change from baseline in VAS score||Statistical analysis results of pain score using VAS scale at End of Study||-0.32|-16.26|0.087
73863230|NCT03344640|147272635|SUPERIORITY||Difference and 99% CL versus placebo|6.1||||0.21|TWO_SIDED|90.0|-1.9|13.91|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of PhGA score using VAS scale at day 99||13.91|-1.90|0.210
73863231|NCT03344640|147272635|SUPERIORITY||Difference and 90% CI versus placebo|-0.37||||0.942|TWO_SIDED|90.0|-8.86|8.11|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of PhGA score using VAS scale at End of Study||8.11|-8.86|0.942
73863232|NCT04135859|147272655|SUPERIORITY||Mean Difference (Final Values)|10.3||||0.023|TWO_SIDED||||||Mixed Models Analysis|||||||.023
73863233|NCT04135859|147272656|SUPERIORITY||Mean Difference (Final Values)|-59.0||||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||.06
73863234|NCT04135859|147272657|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.43|TWO_SIDED||||||Mixed Models Analysis|||||||.43
73863235|NCT01943552|147272661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|154.9|STANDARD_ERROR_OF_MEAN|32.32|<|0.0001|TWO_SIDED|95.0|91.08|218.63|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of FEV1 from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||218.63|91.08|<0.0001
73863236|NCT01943552|147272662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|51.0|STANDARD_ERROR_OF_MEAN|54.48||0.3509|TWO_SIDED|95.0|-56.55|158.46|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of forced vital capacity (FVC) from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||158.46|-56.55|0.3509
73863237|NCT01943552|147272663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|2.18||0.2069|TWO_SIDED|95.0|-1.54|7.07|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||7.07|-1.54|0.2069
73863238|NCT01943552|147272664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1899|TWO_SIDED|95.0|-0.19|0.93|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for Oxygen saturation between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||0.93|-0.19|0.1899
73863239|NCT01943552|147272665|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.57||0.4758|TWO_SIDED|95.0|-0.72|1.55|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaCO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||1.55|-0.72|0.4758
74084284|NCT01525628|147721696|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|73.93|STANDARD_DEVIATION|21.6||0.8646|TWO_SIDED|90.0|65.55|83.39|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||83.39|65.55|0.8646
73843519|NCT03440385|147234831|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8125|TWO_SIDED|95.0|0.66|1.39|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.39|0.66|0.8125
73843520|NCT03440385|147234832|SUPERIORITY||Odds Ratio (OR)|1.13||||0.54|TWO_SIDED|95.0|0.77|1.66|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.66|0.77|0.5400
73843521|NCT03440385|147234833|SUPERIORITY||Odds Ratio (OR)|1.28||||0.2411|TWO_SIDED|95.0|0.85|1.95|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.95|0.85|0.2411
73843522|NCT03440385|147234834|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7469|TWO_SIDED|95.0|0.67|1.34|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.34|0.67|0.7469
73843523|NCT03440385|147234835|SUPERIORITY||Odds Ratio (OR)|1.22||||0.4255|TWO_SIDED|95.0|0.75|1.97|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.97|0.75|0.4255
73843524|NCT03440385|147234836|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9313|TWO_SIDED|95.0|0.6|1.76|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.76|0.60|0.9313
73843525|NCT03440385|147234837|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4339|TWO_SIDED|95.0|0.7|2.31|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||2.31|0.70|0.4339
73843526|NCT03440385|147234838|SUPERIORITY||Odds Ratio (OR)|1.3||||0.333|TWO_SIDED|95.0|0.77|2.2|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||2.20|0.77|0.3330
73843527|NCT03440385|147234839|SUPERIORITY||Odds Ratio (OR)|1.04||||0.82|TWO_SIDED|95.0|0.74|1.47|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.47|0.74|0.8200
73843528|NCT03440385|147234840|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7776|TWO_SIDED|95.0|0.71|1.59|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.59|0.71|0.7776
73843529|NCT03440385|147234841|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1187|TWO_SIDED|95.0|0.92|2.11|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no)||||2.11|0.92|0.1187
73843530|NCT03440385|147234842|SUPERIORITY||Odds Ratio (OR)|1.28||||0.403|TWO_SIDED|95.0|0.72|2.26|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no)||||2.26|0.72|0.4030
73843531|NCT03440385|147234843|SUPERIORITY||Odds Ratio (OR)|0.79||||0.563|TWO_SIDED|95.0|0.35|1.78|||Mantel Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.78|0.35|0.5630
73843532|NCT01168596|147234850|SUPERIORITY_OR_OTHER||Slope|1.3|STANDARD_ERROR_OF_MEAN|5.26||0.81|TWO_SIDED|95.0|-9.13|11.73|||Regression, Linear|||||11.73|-9.13|0.81
73843533|NCT01168596|147234851|SUPERIORITY_OR_OTHER||Slope|4.38|STANDARD_ERROR_OF_MEAN|3.6||0.23|TWO_SIDED|95.0|-2.75|11.51|||Regression, Linear|||||11.51|-2.75|0.23
73959861|NCT01786564|147454948|OTHER|Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression Coefficient|-0.058||||0.11|TWO_SIDED|95.0|-0.129|0.014||Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression, Linear|Unadjusted association.||The cross-sectional association between amount of REM sleep and oral disposition index was analyzed.||.014|-.129|.11
73843534|NCT01168596|147234852|SUPERIORITY_OR_OTHER||Slope|1.61|STANDARD_ERROR_OF_MEAN|5.03||0.75|TWO_SIDED|95.0|-8.37|11.59|||Regression, Linear|||||11.59|-8.37|0.75
73843535|NCT01168596|147234853|SUPERIORITY_OR_OTHER||Slope|1.88|STANDARD_ERROR_OF_MEAN|3.06||0.54|TWO_SIDED|95.0|-4.18|7.94|||Regression, Linear|||||7.94|-4.18|0.54
73843536|NCT01168596|147234854|SUPERIORITY_OR_OTHER||Slope|-5.17|STANDARD_ERROR_OF_MEAN|6.36||0.42|TWO_SIDED|95.0|-17.76|7.43|||Regression, Linear|||||7.43|-17.76|0.42
73843537|NCT01168596|147234855|SUPERIORITY_OR_OTHER||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.47||0.44|TWO_SIDED|95.0|-0.56|1.29|||Regression, Linear|||||1.29|-0.56|0.44
73959862|NCT01924767|147454959|SUPERIORITY_OR_OTHER||Geometric Mean of ratio|43.661|||||TWO_SIDED|95.0|27.52|69.269|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax (single dose) was analysed.||69.269|27.520|
73959863|NCT01924767|147454959|SUPERIORITY_OR_OTHER||Geometric Mean of ratio|31.234|||||TWO_SIDED|95.0|12.193|80.011|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax,ss (Multiple dose) was analysed.||80.011|12.193|
73843538|NCT01168596|147234856|SUPERIORITY_OR_OTHER||Slope|2.27|STANDARD_ERROR_OF_MEAN|10.02||0.82|TWO_SIDED|95.0|-17.59|22.13|||Regression, Linear|||||22.13|-17.59|0.82
73843539|NCT01168596|147234857|SUPERIORITY_OR_OTHER||Slope|-4.73|STANDARD_ERROR_OF_MEAN|7.36||0.52|TWO_SIDED|95.0|-19.31|9.85|||Regression, Linear|||||9.85|-19.31|0.52
73843540|NCT01168596|147234858|SUPERIORITY_OR_OTHER||Slope|0.11|STANDARD_ERROR_OF_MEAN|1.14||0.93|TWO_SIDED|95.0|-2.15|2.36|||Regression, Linear|||||2.36|-2.15|0.93
73843541|NCT01168596|147234859|SUPERIORITY_OR_OTHER||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.47||0.82|TWO_SIDED|95.0|-1.05|0.83|||Regression, Linear|||||0.83|-1.05|0.82
73843542|NCT01168596|147234860|SUPERIORITY_OR_OTHER||Slope|-4.53|STANDARD_ERROR_OF_MEAN|7.68||0.56|TWO_SIDED|95.0|-19.74|10.69|||Regression, Linear|||||10.69|-19.74|0.56
73843543|NCT01168596|147234861|SUPERIORITY_OR_OTHER||Slope|-2.21|STANDARD_ERROR_OF_MEAN|2.93||0.45|TWO_SIDED|95.0|-8.02|3.59|||Regression, Linear|||||3.59|-8.02|0.45
73843544|NCT01168596|147234862|SUPERIORITY_OR_OTHER||Slope|2.76|STANDARD_ERROR_OF_MEAN|4.94||0.58|TWO_SIDED|95.0|-7.02|12.55|||Regression, Linear|||||12.55|-7.02|0.58
73843545|NCT01168596|147234863|SUPERIORITY_OR_OTHER||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.54||0.95|TWO_SIDED|95.0|-1.04|1.11|||Regression, Linear|||||1.11|-1.04|0.95
73843546|NCT01168596|147234864|SUPERIORITY_OR_OTHER||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.54||0.48|TWO_SIDED|95.0|-1.45|0.69|||Regression, Linear|||||0.69|-1.45|0.48
73843547|NCT01168596|147234865|SUPERIORITY_OR_OTHER||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.84|TWO_SIDED|95.0|-0.71|0.58|||Regression, Linear|||||0.58|-0.71|0.84
73843548|NCT01168596|147234866|SUPERIORITY_OR_OTHER||Slope|0.49|STANDARD_ERROR_OF_MEAN|0.64||0.44|TWO_SIDED|95.0|-0.77|1.76|||Regression, Linear|||||1.76|-0.77|0.44
73843549|NCT01168596|147234867|SUPERIORITY_OR_OTHER||Slope|-0.33|STANDARD_ERROR_OF_MEAN|0.88||0.71|TWO_SIDED|95.0|-2.06|1.41|||Regression, Linear|||||1.41|-2.06|0.71
73843550|NCT01168596|147234868|SUPERIORITY_OR_OTHER||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.64||0.31|TWO_SIDED|95.0|-0.62|1.9|||Regression, Linear|||||1.90|-0.62|0.31
73843551|NCT01168596|147234869|SUPERIORITY_OR_OTHER||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.82||0.94|TWO_SIDED|95.0|-1.68|1.56|||Regression, Linear|||||1.56|-1.68|0.94
73843552|NCT00123630|147234894|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
73843553|NCT01098747|147234895|SUPERIORITY_OR_OTHER||Least-square (LS) mean difference|24.21|||<|0.001|TWO_SIDED|95.0|19.32|29.09||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium - placebo) and 95 percent (%) confidence interval (CI):based on LS means from analysis of variance(ANOVA). Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: Ibuprofen sodium (IBU Na) versus(vs.) Placebo for SPRID 0-8 then time to meaningful relief(TMR), IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||29.09|19.32|<0.001
73843554|NCT01098747|147234896|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|12.8|||<|0.001|TWO_SIDED|95.0|6.78|24.15||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||24.15|6.78|<0.001
73843555|NCT01098747|147234896|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59|||<|0.001|TWO_SIDED|95.0|1.22|2.06||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||2.06|1.22|<0.001
73843556|NCT01098747|147234897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|12.36|||<|0.001|TWO_SIDED|95.0|6.51|23.46||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||23.46|6.51|<0.001
73843557|NCT01098747|147234897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8|||<|0.001|TWO_SIDED|95.0|1.38|2.34||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||2.34|1.38|<0.001
73843558|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|0.35||||0.007|TWO_SIDED|95.0|0.1|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.60|0.10|0.007
73843559|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|0.24||||0.01|TWO_SIDED|95.0|0.06|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.42|0.06|0.010
73843560|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|1.47|||<|0.001|TWO_SIDED|95.0|1.1|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95 % CI were calculated based on LS mean from the ANOVA model.||1.84|1.10|<0.001
73843561|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|0.53|||<|0.001|TWO_SIDED|95.0|0.27|0.8||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.80|0.27|<0.001
73843562|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|2.22|||<|0.001|TWO_SIDED|95.0|1.84|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.60|1.84|<0.001
73843563|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|0.39||||0.006|TWO_SIDED|95.0|0.12|0.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.66|0.12|0.006
73843564|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|2.0|2.77||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.77|2.00|<0.001
73843565|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.022|TWO_SIDED|95.0|0.05|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.60|0.05|0.022
73843566|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|2.0|2.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.79|2.00|<0.001
73843567|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|0.13||||0.369|TWO_SIDED|95.0|-0.15|0.41||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.41|-0.15|0.369
73843568|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|2.19|||<|0.001|TWO_SIDED|95.0|1.78|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.60|1.78|<0.001
73843569|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.42|TWO_SIDED|95.0|-0.42|0.17||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.17|-0.42|0.420
73843570|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|2.02|||<|0.001|TWO_SIDED|95.0|1.58|2.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.45|1.58|<0.001
73843571|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.151|TWO_SIDED|95.0|-0.54|0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.08|-0.54|0.151
73843572|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.43|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.33|1.43|<0.001
73843573|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.16|TWO_SIDED|95.0|-0.56|0.09||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.09|-0.56|0.160
73843574|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.16|2.1||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.10|1.16|<0.001
73843575|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|-0.33||||0.055|TWO_SIDED|95.0|-0.67|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.01|-0.67|0.055
73843576|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|1.39|||<|0.001|TWO_SIDED|95.0|0.91|1.88||p-value was calculated using ANOVA model with treatment, baseline PSR and gender PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.88|0.91|<0.001
73843577|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|-0.37||||0.04|TWO_SIDED|95.0|-0.71|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||-0.02|-0.71|0.040
73843578|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.71|1.69||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.69|0.71|<0.001
73843579|NCT01098747|147234898|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.015|TWO_SIDED|95.0|-0.79|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||-0.08|-0.79|0.015
73898527|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|-0.25|STANDARD_DEVIATION|1.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|||||
73843580|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||<|0.001|TWO_SIDED|95.0|0.13|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.13|<0.001
73843581|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|0.22|||<|0.001|TWO_SIDED|95.0|0.11|0.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|0.11|<0.001
73843582|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|0.94|||<|0.001|TWO_SIDED|95.0|0.7|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.19|0.70|<0.001
73843583|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|0.38|||<|0.001|TWO_SIDED|95.0|0.2|0.55||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.55|0.20|<0.001
73843584|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.18|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.75|1.18|<0.001
73843585|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.017|TWO_SIDED|95.0|0.04|0.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|0.04|0.017
73843586|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|1.67|||<|0.001|TWO_SIDED|95.0|1.39|1.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.96|1.39|<0.001
73843587|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.015|TWO_SIDED|95.0|0.05|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.05|0.015
73843588|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.41|1.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.98|1.41|<0.001
73843589|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.362|TWO_SIDED|95.0|-0.11|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.30|-0.11|0.362
73843590|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|1.56|||<|0.001|TWO_SIDED|95.0|1.27|1.86||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.86|1.27|<0.001
73843591|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|-0.08||||0.472|TWO_SIDED|95.0|-0.29|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.29|0.472
73843592|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|1.39|||<|0.001|TWO_SIDED|95.0|1.07|1.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.70|1.07|<0.001
73843593|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|-0.17||||0.134|TWO_SIDED|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.05|-0.40|0.134
73843594|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|1.31|||<|0.001|TWO_SIDED|95.0|1.0|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.63|1.00|<0.001
74084285|NCT01525628|147721696|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|75.42|STANDARD_DEVIATION|16.4||0.8378|TWO_SIDED|90.0|68.15|83.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||83.45|68.15|0.8378
73843595|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|-0.17||||0.135|TWO_SIDED|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.05|-0.40|0.135
73843596|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.84|1.5||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.84|<0.001
73843597|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.036|TWO_SIDED|95.0|-0.49|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-0.49|0.036
73843598|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.61|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.26|0.61|<0.001
73843599|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|-0.22||||0.064|TWO_SIDED|95.0|-0.46|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.01|-0.46|0.064
73843600|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|0.85|||<|0.001|TWO_SIDED|95.0|0.52|1.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.18|0.52|<0.001
73843601|NCT01098747|147234899|SUPERIORITY_OR_OTHER||LS mean difference|-0.22||||0.074|TWO_SIDED|95.0|-0.46|0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.02|-0.46|0.074
73843602|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|0.65||||0.001|TWO_SIDED|95.0|0.26|1.04||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.04|0.26|0.001
73843603|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|0.46||||0.001|TWO_SIDED|95.0|0.18|0.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.75|0.18|0.001
73843604|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|2.41|||<|0.001|TWO_SIDED|95.0|1.82|3.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.01|1.82|<0.001
73843605|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|0.91|||<|0.001|TWO_SIDED|95.0|0.48|1.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.34|0.48|<0.001
73843606|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||<|0.001|TWO_SIDED|95.0|3.03|4.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.33|3.03|<0.001
73843607|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|0.64||||0.008|TWO_SIDED|95.0|0.17|1.11||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.11|0.17|0.008
73843608|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|4.06|||<|0.001|TWO_SIDED|95.0|3.4|4.72||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.72|3.40|<0.001
73843609|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|0.58||||0.017|TWO_SIDED|95.0|0.1|1.06||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.06|0.10|0.017
73843610|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|4.09|||<|0.001|TWO_SIDED|95.0|3.42|4.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.75|3.42|<0.001
73959864|NCT01924767|147454960|SUPERIORITY_OR_OTHER||Geometric mean of ratio|49.707|||||TWO_SIDED|95.0|33.49|73.776|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, single dose) was analysed.||73.776|33.490|
73843611|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|0.22||||0.359|TWO_SIDED|95.0|-0.26|0.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.70|-0.26|0.359
73843612|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|3.75|||<|0.001|TWO_SIDED|95.0|3.06|4.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.45|3.06|<0.001
73843613|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.436|TWO_SIDED|95.0|-0.7|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.30|-0.70|0.436
73843614|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|3.4|||<|0.001|TWO_SIDED|95.0|2.66|4.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.14|2.66|<0.001
73843615|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.139|TWO_SIDED|95.0|-0.93|0.13||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.93|0.139
73843616|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|3.2|||<|0.001|TWO_SIDED|95.0|2.44|3.95||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.95|2.44|<0.001
73843617|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|-0.41||||0.144|TWO_SIDED|95.0|-0.95|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.95|0.144
73843618|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|2.8|||<|0.001|TWO_SIDED|95.0|2.01|3.58||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.58|2.01|<0.001
73843619|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|-0.58||||0.043|TWO_SIDED|95.0|-1.15|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-1.15|0.043
73843620|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|2.33|||<|0.001|TWO_SIDED|95.0|1.53|3.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.12|1.53|<0.001
73843621|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|-0.59||||0.044|TWO_SIDED|95.0|-1.16|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-1.16|0.044
73843622|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|2.05|||<|0.001|TWO_SIDED|95.0|1.25|2.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.85|1.25|<0.001
74084286|NCT01525628|147721697|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|98.17|STANDARD_DEVIATION|12.3||0.0005|TWO_SIDED|90.0|90.15|106.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||106.91|90.15|0.0005
73843623|NCT01098747|147234900|SUPERIORITY_OR_OTHER||LS mean difference|-0.65||||0.027|TWO_SIDED|95.0|-1.23|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.08|-1.23|0.027
73843624|NCT01098747|147234901|SUPERIORITY_OR_OTHER||LS mean difference|2.73|||<|0.001|TWO_SIDED|95.0|2.27|3.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.18|2.27|<0.001
73843625|NCT01098747|147234901|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.007|TWO_SIDED|95.0|0.12|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.78|0.12|0.007
73843626|NCT01098747|147234901|SUPERIORITY_OR_OTHER||LS mean difference|4.29|||<|0.001|TWO_SIDED|95.0|3.6|4.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.98|3.60|<0.001
73843627|NCT01098747|147234901|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.144|TWO_SIDED|95.0|-0.13|0.87||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.87|-0.13|0.144
73843628|NCT01098747|147234901|SUPERIORITY_OR_OTHER||LS mean difference|8.16|||<|0.001|TWO_SIDED|95.0|6.66|9.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||9.66|6.66|<0.001
73843629|NCT01098747|147234901|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.679|TWO_SIDED|95.0|-1.31|0.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.85|-1.31|0.679
73843630|NCT01098747|147234901|SUPERIORITY_OR_OTHER||LS mean difference|9.94|||<|0.001|TWO_SIDED|95.0|7.92|11.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||11.96|7.92|<0.001
73843631|NCT01098747|147234901|SUPERIORITY_OR_OTHER||LS mean difference|-0.67||||0.367|TWO_SIDED|95.0|-2.12|0.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.79|-2.12|0.367
73843632|NCT01098747|147234902|SUPERIORITY_OR_OTHER||LS mean difference|3.95|||<|0.001|TWO_SIDED|95.0|3.32|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.59|3.32|< 0.001
73843633|NCT01098747|147234902|SUPERIORITY_OR_OTHER||LS mean difference|0.62||||0.009|TWO_SIDED|95.0|0.16|1.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.07|0.16|0.009
73843634|NCT01098747|147234902|SUPERIORITY_OR_OTHER||LS mean difference|6.15|||<|0.001|TWO_SIDED|95.0|5.18|7.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.12|5.18|<0.001
73843635|NCT01098747|147234902|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.166|TWO_SIDED|95.0|-0.21|1.2||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.20|-0.21|0.166
73843636|NCT01098747|147234902|SUPERIORITY_OR_OTHER||LS mean difference|11.67|||<|0.001|TWO_SIDED|95.0|9.54|13.81||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||13.81|9.54|<0.001
73843637|NCT01098747|147234902|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.703|TWO_SIDED|95.0|-1.84|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.24|-1.84|0.703
73843638|NCT01098747|147234902|SUPERIORITY_OR_OTHER||LS mean difference|14.27|||<|0.001|TWO_SIDED|95.0|11.36|17.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||17.18|11.36|<0.001
73843639|NCT01098747|147234902|SUPERIORITY_OR_OTHER||LS mean difference|-1.1||||0.303|TWO_SIDED|95.0|-3.2|1.0||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.00|-3.20|0.303
73843640|NCT01098747|147234903|SUPERIORITY_OR_OTHER||LS mean difference|6.68|||<|0.001|TWO_SIDED|95.0|5.6|7.76||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||7.76|5.60|<0.001
73959865|NCT01924767|147454960|SUPERIORITY_OR_OTHER||Geometric mean of ratio|37.632|||||TWO_SIDED|95.0|15.429|91.789|||Regression, Linear|||This was non confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, at steady state, day 9) was analysed.||91.789|15.429|
73959866|NCT01924767|147454971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37645.43||||0.0067|TWO_SIDED|95.0|11021.57|64269.3||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.||The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||64269.30|11021.57|0.0067
73843641|NCT01098747|147234903|SUPERIORITY_OR_OTHER||LS mean difference|1.06||||0.007|TWO_SIDED|95.0|0.29|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.84|0.29|0.007
73843642|NCT01098747|147234903|SUPERIORITY_OR_OTHER||LS mean difference|10.43|||<|0.001|TWO_SIDED|95.0|8.79|12.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||12.08|8.79|<0.001
73843643|NCT01098747|147234903|SUPERIORITY_OR_OTHER||LS mean difference|0.87||||0.152|TWO_SIDED|95.0|-0.32|2.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.05|-0.32|0.152
73843644|NCT01098747|147234903|SUPERIORITY_OR_OTHER||LS mean difference|19.83|||<|0.001|TWO_SIDED|95.0|16.23|23.43||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||23.43|16.23|<0.001
73843645|NCT01098747|147234903|SUPERIORITY_OR_OTHER||LS mean difference|-0.53||||0.69|TWO_SIDED|95.0|-3.12|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.07|-3.12|0.690
74022439|NCT01431287|147597109|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.211|STANDARD_ERROR_OF_MEAN|0.136||0.122|TWO_SIDED|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.478|-0.056|0.1220
73843646|NCT01098747|147234903|SUPERIORITY_OR_OTHER||LS mean difference|-1.77||||0.323|TWO_SIDED|95.0|-5.29|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-8 Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.75|-5.29|0.323
73843647|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|1.01||||0.49|TWO_SIDED|95.0|-0.97|3.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours-Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||3.00|-0.97|0.490
73843648|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|0.54||||0.623|TWO_SIDED|95.0|-1.88|2.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.95|-1.88|0.623
73843649|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|24.36|||<|0.001|TWO_SIDED|95.0|13.51|35.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||35.22|13.51|<0.001
73843650|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|11.82||||0.023|TWO_SIDED|95.0|1.15|22.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.48|1.15|0.023
73843651|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|61.35|||<|0.001|TWO_SIDED|95.0|48.99|73.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.70|48.99|<0.001
74084287|NCT01525628|147721697|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|81.26|STANDARD_DEVIATION|11.7||0.3638|TWO_SIDED|90.0|75.19|87.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||87.82|75.19|0.3638
73843652|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|21.25|||<|0.001|TWO_SIDED|95.0|9.58|32.92||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||32.92|9.58|<0.001
74022440|NCT01431287|147597109|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.438|STANDARD_ERROR_OF_MEAN|0.137||0.0014|TWO_SIDED|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.707|0.170|0.0014
73843653|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|72.65|||<|0.001|TWO_SIDED|95.0|61.59|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.71|61.59|<0.001
73843654|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|17.44||||0.001|TWO_SIDED|95.0|7.83|27.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.06|7.83|0.001
73843655|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|72.63|||<|0.001|TWO_SIDED|95.0|61.14|84.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.11|61.14|<0.001
73843656|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|11.7||||0.013|TWO_SIDED|95.0|3.47|19.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.93|3.47|0.013
73843657|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
73843658|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|8.01||||0.041|TWO_SIDED|95.0|1.27|14.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.75|1.27|0.041
73843659|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
73843660|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
73843661|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
73843662|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
73843663|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
73843664|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
73843665|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|74.71|||<|0.001|TWO_SIDED|95.0|63.14|86.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.27|63.14|<0.001
73843666|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|7.84||||0.035|TWO_SIDED|95.0|1.57|14.1||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.10|1.57|0.035
73898528|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.135||0.065|TWO_SIDED|95.0|-0.514|0.016||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.016|-0.514|0.065
74022441|NCT01431287|147597109|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.196|STANDARD_ERROR_OF_MEAN|0.137||0.1542|TWO_SIDED|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.465|-0.074|0.1542
73843667|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
73843668|NCT01098747|147234904|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
73843669|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|20.01||||0.004|TWO_SIDED|95.0|8.79|31.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.24|8.79|0.004
73843670|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|14.35||||0.003|TWO_SIDED|95.0|4.26|24.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.43|4.26|0.003
73843671|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|69.53|||<|0.001|TWO_SIDED|95.0|57.67|81.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.40|57.67|<0.001
73843672|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|23.45|||<|0.001|TWO_SIDED|95.0|13.16|33.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||33.75|13.16|<0.001
73843673|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|73.72|||<|0.001|TWO_SIDED|95.0|62.77|84.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.67|62.77|<0.001
73843674|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|10.14||||0.014|TWO_SIDED|95.0|3.21|17.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.08|3.21|0.014
73843675|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
73843676|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|8.35||||0.028|TWO_SIDED|95.0|2.02|14.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.68|2.02|0.028
73843677|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
73843678|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|7.81||||0.036|TWO_SIDED|95.0|1.54|14.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.08|1.54|0.036
74084288|NCT01525628|147721697|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.93|STANDARD_DEVIATION|22.6||0.8975|TWO_SIDED|90.0|60.44|83.22|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||83.22|60.44|0.8975
73898529|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73843679|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
73843680|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
73843681|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
73843682|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
73843683|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
73843684|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
73843685|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
73843686|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
73843687|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
73843688|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
73843689|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
73843690|NCT01098747|147234905|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
73843691|NCT01098747|147234906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.22|0.08|<0.001
73843692|NCT01098747|147234906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||0.281|TWO_SIDED|95.0|0.79|2.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||2.22|0.79|0.281
73843693|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|-23.93|||<|0.001|TWO_SIDED|95.0|-36.67|-11.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-11.20|-36.67|<0.001
73843694|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.483|TWO_SIDED|95.0|-4.12|1.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.70|-4.12|0.483
73843695|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|-51.93|||<|0.001|TWO_SIDED|95.0|-65.63|-38.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-38.22|-65.63|<0.001
73843696|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|-3.61||||0.174|TWO_SIDED|95.0|-7.97|0.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||0.75|-7.97|0.174
73843697|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|-66.58|||<|0.001|TWO_SIDED|95.0|-79.8|-53.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-53.35|-79.80|<0.001
73843698|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|-3.75||||0.24|TWO_SIDED|95.0|-9.38|1.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.89|-9.38|0.240
73843699|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|-61.36|||<|0.001|TWO_SIDED|95.0|-75.21|-47.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-47.50|-75.21|<0.001
73843700|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|1.52||||0.668|TWO_SIDED|95.0|-5.47|8.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.52|-5.47|0.668
73843701|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|-60.31|||<|0.001|TWO_SIDED|95.0|-74.28|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.34|-74.28|<0.001
73843702|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|1.1||||0.98|TWO_SIDED|95.0|-7.44|7.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.63|-7.44|0.980
73843703|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|-59.28|||<|0.001|TWO_SIDED|95.0|-73.05|-45.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-45.50|-73.05|<0.001
73843704|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|1.56||||0.711|TWO_SIDED|95.0|-6.68|9.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.81|-6.68|0.711
73843705|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|-56.84|||<|0.001|TWO_SIDED|95.0|-70.84|-42.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-42.85|-70.84|<0.001
73843706|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|3.72||||0.445|TWO_SIDED|95.0|-5.94|13.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.38|-5.94|0.445
73959867|NCT01924767|147454971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|82898.2|||<|0.0001|TWO_SIDED|95.0|55344.83|110451.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||110451.6|55344.83|<0.0001
73959868|NCT01924767|147454971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79982.89|||<|0.0001|TWO_SIDED|95.0|53087.22|106878.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||106878.6|53087.22|<0.0001
73843707|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|-52.79|||<|0.001|TWO_SIDED|95.0|-66.77|-38.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-38.81|-66.77|<0.001
73843708|NCT01098747|147234907|SUPERIORITY_OR_OTHER||Difference in proportion|6.05||||0.256|TWO_SIDED|95.0|-4.75|16.84||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.84|-4.75|0.256
73843709|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|6.34||||0.078|TWO_SIDED|95.0|1.34|11.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.34|1.34|0.078
73843710|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|2.74||||0.303|TWO_SIDED|95.0|-3.01|8.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.49|-3.01|0.303
73843711|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|27.24|||<|0.001|TWO_SIDED|95.0|18.14|36.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.34|18.14|<0.001
73843712|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|6.66||||0.217|TWO_SIDED|95.0|-4.31|17.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.63|-4.31|0.217
73843713|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|41.16|||<|0.001|TWO_SIDED|95.0|31.2|51.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.12|31.20|<0.001
73843714|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|8.86||||0.149|TWO_SIDED|95.0|-3.33|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.04|-3.33|0.149
73843715|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|48.61|||<|0.001|TWO_SIDED|95.0|38.49|58.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||58.73|38.49|<0.001
73843716|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|4.55||||0.477|TWO_SIDED|95.0|-8.03|17.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.13|-8.03|0.477
73843717|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|52.81|||<|0.001|TWO_SIDED|95.0|42.63|62.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||62.99|42.63|<0.001
73843718|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|-2.14||||0.739|TWO_SIDED|95.0|-14.77|10.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.50|-14.77|0.739
73843719|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
73843720|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|-6.8||||0.28|TWO_SIDED|95.0|-19.24|5.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.65|-19.24|0.280
73843721|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
73843722|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|-8.01||||0.202|TWO_SIDED|95.0|-20.44|4.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.41|-20.44|0.202
73843723|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
73843724|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|-8.61||||0.17|TWO_SIDED|95.0|-21.02|3.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.80|-21.02|0.170
73843725|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
73843726|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|-9.23||||0.14|TWO_SIDED|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.16|-21.62|0.140
73843727|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
73843728|NCT01098747|147234908|SUPERIORITY_OR_OTHER||Difference in proportion|-9.23||||0.14|TWO_SIDED|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.16|-21.62|0.140
73843729|NCT01098747|147234909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.83|0.98||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.98|0.83|<0.001
74022442|NCT01431287|147597109|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.137||0.1626|TWO_SIDED|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.461|-0.077|0.1626
74084289|NCT01525628|147721697|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|86.37|STANDARD_DEVIATION|18.1||0.1144|TWO_SIDED|90.0|77.62|96.11|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||96.11|77.62|0.1144
73843730|NCT01098747|147234909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.04||||0.667|TWO_SIDED|95.0|-0.15|0.24||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.24|-0.15|0.667
73843731|NCT00189423|147234910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.019|TWO_SIDED|95.0|1.07|2.36|||Fisher Exact|||||2.36|1.07|0.019
73843732|NCT00189423|147234911|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 5%||||||0.0001|TWO_SIDED|95.0||||p value is for non-inferiority with a margin of 5% (exact binomial test)|Fisher Exact test, for non-inferiority|||||||0.0001
73843733|NCT00189423|147234911|SUPERIORITY_OR_OTHER|||||||0.681|TWO_SIDED|95.0|||||Fisher Exact|||||||0.681
73843734|NCT00189423|147234917|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|95.0|||||Fisher Exact|||||||0.024
73843735|NCT03309202|147235010|OTHER||Mean Difference (Final Values)|130.47|||||TWO_SIDED|90.0|101.57|167.6|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||167.60|101.57|
73843736|NCT03309202|147235010|OTHER||Mean Difference (Final Values)|117.49|||||TWO_SIDED|90.0|91.46|150.93|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||150.93|91.46|
73843737|NCT03309202|147235010|OTHER||Mean Difference (Final Values)|130.55|||||TWO_SIDED|90.0|101.63|167.7|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||167.70|101.63|
73843738|NCT03309202|147235011|OTHER||Mean Difference (Final Values)|136.37|||||TWO_SIDED|90.0|94.63|196.53|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||196.53|94.63|
73843739|NCT03309202|147235011|OTHER||Mean Difference (Final Values)|124.23|||||TWO_SIDED|90.0|86.2|179.03|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||179.03|86.20|
73843740|NCT03309202|147235011|OTHER||Mean Difference (Final Values)|118.65|||||TWO_SIDED|90.0|82.33|170.99|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||170.99|82.33|
73843741|NCT03309202|147235012|OTHER||Mean Difference (Final Values)|124.7309|||||TWO_SIDED|90.0|82.5275|188.5165|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||188.5165|82.5275|
73843742|NCT03309202|147235012|OTHER||Mean Difference (Final Values)|147.0778|||||TWO_SIDED|90.0|97.3132|222.2911|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||222.2911|97.3132|
73843743|NCT03309202|147235012|OTHER||Mean Difference (Final Values)|224.7373|||||TWO_SIDED|90.0|148.6962|339.6647|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||339.6647|148.6962|
73843744|NCT03309202|147235013|OTHER||Mean Difference (Final Values)|162.58|||||TWO_SIDED|90.0|103.12|256.32|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||256.32|103.12|
73843745|NCT03309202|147235013|OTHER||Mean Difference (Final Values)|172.74|||||TWO_SIDED|90.0|109.56|272.35|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||272.35|109.56|
73843746|NCT03309202|147235013|OTHER||Mean Difference (Final Values)|293.31|||||TWO_SIDED|90.0|186.04|462.44|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||462.44|186.04|
73843747|NCT03309202|147235014|OTHER||Mean Difference (Final Values)|169.84|||||TWO_SIDED|90.0|104.02|277.32|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||277.32|104.02|
73843748|NCT03309202|147235014|OTHER||Mean Difference (Final Values)|182.51|||||TWO_SIDED|90.0|111.78|298.02|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||298.02|111.78|
73843749|NCT03309202|147235014|OTHER||Mean Difference (Final Values)|266.29|||||TWO_SIDED|90.0|163.08|434.8|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||434.80|163.08|
73843750|NCT04734210|147235029|OTHER|Exploratory, descriptive analysis||||||0.2933||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.2933
73843751|NCT04734210|147235030|OTHER|Exploratory, descriptive analysis||||||0.1966||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.1966
73843752|NCT04734210|147235031|OTHER|Exploratory, descriptive analysis||||||0.0213||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.0213
74022443|NCT01431287|147597109|SUPERIORITY_OR_OTHER||djusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.138||0.9765|TWO_SIDED|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.274|-0.265|0.9765
73843753|NCT02138825|147235032|SUPERIORITY_OR_OTHER||LS mean difference|21.48||||0.2074|TWO_SIDED|95.0|-8.75|51.71|||ANCOVA|||The evaluation of primary efficacy endpoint will be based on change from baseline in 6MWD using analysis of covariance (ANCOVA) with baseline 6MWD, treatment arm and region as factors.||51.71|-8.75|0.2074
73843754|NCT02138825|147235033|SUPERIORITY_OR_OTHER|||||||0.3437|||||||Mantel Haenszel|||The difference in incidences in clinical worsening and mortality will be analyzed using Mantel-Haenszel weights, stratified by region.||||0.3437
73843755|NCT00127439|147235106|NON_INFERIORITY_OR_EQUIVALENCE|The power analysis indicated that when the mean difference equals to 1.2 times of standard deviation, a two-sided t-test at 0.05 level will have 80% power; and for a mean difference of 1.4 times of standard deviation the power increases to 91%. To test the null hypothesis that correlation will be 0 at 0.5 level, a two-sided test based on Fisher's Z transformation will yield a power of 89% in detecting correlations of 0.6 or above with n=24 or above.||||||0.05|||||||t-test, 2 sided|||||||0.05
73843756|NCT00127439|147235106|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon rank sum test|||Pearson correlation of gait speed changes with directional difference of standardized kinematic scores (i.e. foot trajectory toe-off - degrees, foot trajectory toe-off - % cycle, foot trajectory initial contact - degrees, foot trajectory range - degrees, propulsive impulse N-s, minimum thigh angle - flexion degrees, minimum hip angle - extension degrees, trunk angle mid-stance)||||0.05
73843757|NCT00127439|147235107|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
73843758|NCT00127439|147235108|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously||||||0.05|||||||t-test, 2 sided|||||||0.05
73843759|NCT00127439|147235109|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously||||||0.05|||||||t-test, 2 sided|||||||0.05
73843760|NCT00127439|147235110|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
73843761|NCT00127439|147235111|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
73843762|NCT00127439|147235112|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
73843763|NCT00127439|147235113|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
74084290|NCT01525628|147721697|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|64.66|STANDARD_DEVIATION|11.8||1|TWO_SIDED|90.0|60.42|69.2|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||69.20|60.42|1.0000
73843764|NCT00127439|147235114|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
73843765|NCT01137890|147235115|SUPERIORITY||F-value for main effect of Coc dose|24.9|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on VAQ score|||||<0.01
73843766|NCT01137890|147235115|SUPERIORITY||F-value for main effect of Zon dose|0.34||||0.72|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose on VAQ score|||||0.72
73843767|NCT01137890|147235115|SUPERIORITY||F-value for main effect of Coc x Zon|0.66||||0.63|TWO_SIDED||||||ANOVA||F-value for main effect of Cocaine x Zonisamide interaction on VAQ scores|||||0.63
73843768|NCT01137890|147235116|SUPERIORITY||F-value for main effect of Coc dose|9.91|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on Behavioral Choice measure|||||<0.01
73843769|NCT01137890|147235116|SUPERIORITY||F-value for main effect of Zon dose|0.07||||0.93|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose on Behavioral Choice measure|||||0.93
73843770|NCT01137890|147235116|SUPERIORITY||F-value for main effect of Coc x Zon|0.24||||0.92|TWO_SIDED||||||ANOVA||F-value for main effect of Cocaine dose x Zonisamide dose interaction on Behavioral Choice measure|||||0.92
73843771|NCT01137890|147235117|SUPERIORITY||t-value for main effect of Group|1.51||||0.16|TWO_SIDED|||||Group (Zonisamide vs Placebo)|t-test, 2 sided|||||||0.16
73843772|NCT01137890|147235117|SUPERIORITY|Day (Day 1-39)|t-value for main effect of Day|-3.2||||0.0015|TWO_SIDED||||||t-test, 2 sided|||||||0.0015
73843773|NCT01137890|147235117|SUPERIORITY|Group\*Day interaction|t value for Group x Day interaction|-1.63||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
73843774|NCT01137890|147235118|SUPERIORITY||F-value for main effect of Coc dose|21.1|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose|||||<0.01
73843775|NCT01137890|147235118|SUPERIORITY||F-value for main effect of Zon dose|0.77||||0.48|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose|||||0.48
73843776|NCT01137890|147235118|SUPERIORITY||F-value for the main effect of Zon x Coc|0.93||||0.46|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide x Cocaine interaction on drug value (i.e., street value) measurement|||||0.46
73843777|NCT00583219|147235119|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline at one month||||0.004
73843778|NCT00583219|147235119|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.81
73843779|NCT00583219|147235120|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.21
73843780|NCT00583219|147235120|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.43
73843781|NCT00583219|147235122|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.005
73843782|NCT00583219|147235123|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.22
73843783|NCT00583219|147235124|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.24
73843784|NCT00583219|147235124|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.14
73843785|NCT00583219|147235125|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.24
73843786|NCT00583219|147235125|SUPERIORITY_OR_OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.033
73843787|NCT00583219|147235126|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Exact binomial sign test|||P value change from baseline to 1 month||||>0.99
73843788|NCT00583219|147235126|SUPERIORITY_OR_OTHER|||||||0.25|||||||exact binomial sign test|||P value change from baseline to 3 months||||0.25
73843789|NCT00583219|147235128|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month||||<0.001
73843790|NCT00583219|147235129|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.004
73843791|NCT00583219|147235130|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.003
73843792|NCT00583219|147235130|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months.||||0.001
73843793|NCT00583219|147235131|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month||||0.001
73843794|NCT00583219|147235131|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||<0.001
73843795|NCT00583219|147235132|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month.||||0.007
73843796|NCT00583219|147235132|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.002
73843797|NCT02090764|147235133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Chi-squared|||The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) was provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.||||0.001
73843798|NCT02384421|147235158|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73843799|NCT02384421|147235159|SUPERIORITY|||||||0.0064|||||||t-test, 2 sided|||||||0.0064
73843800|NCT02384421|147235160|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
73843801|NCT02384421|147235161|SUPERIORITY|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.25
73843802|NCT02384421|147235162|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
73843803|NCT02384421|147235163|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73843804|NCT02958865|147235175|SUPERIORITY||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|0.69||0.0017|TWO_SIDED|90.0|-3.17|-0.89|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-0.89|-3.17|0.0017
73843805|NCT02958865|147235175|SUPERIORITY||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|90.0|-5.01|-2.74|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-2.74|-5.01|< 0.0001
73843806|NCT02958865|147235175|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|90.0|-5.76|-3.46|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-3.46|-5.76|< 0.0001
73843807|NCT02958865|147235175|SUPERIORITY||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|0.68||0.0045|TWO_SIDED|90.0|-2.92|-0.67|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there is no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm is declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect is below zero.||-0.67|-2.92|0.0045
73843808|NCT02958865|147235175|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|0.69||0.0005|TWO_SIDED|90.0|-3.41|-1.14|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-1.14|-3.41|0.0005
73843809|NCT02958865|147235175|SUPERIORITY||Mean Difference (Final Values)|-3.21|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|90.0|-4.34|-2.08|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-2.08|-4.34|< 0.0001
73843810|NCT02958865|147235192|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.0626|TWO_SIDED|90.0|-1.0|19.5|||Chan and Zhang method|||||19.5|-1.0|0.0626
73843811|NCT02958865|147235192|SUPERIORITY||Mean Difference (Final Values)|28.6||||0.0027|TWO_SIDED|90.0|13.9|41.0|||Chan and Zhang method|||||41.0|13.9|0.0027
73843812|NCT02958865|147235192|SUPERIORITY||Mean Difference (Final Values)|34.0||||0.001|TWO_SIDED|90.0|20.2|46.5|||Chan and Zhang Method|||||46.5|20.2|0.0010
73843813|NCT02958865|147235192|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.0774|TWO_SIDED|90.0|-4.0|18.1|||Chan and Zhang method|||||18.1|-4.0|0.0774
73843814|NCT02958865|147235192|SUPERIORITY||Mean Difference (Final Values)|23.4||||0.0055|TWO_SIDED|90.0|8.2|35.8|||Chan and Zhang method|||||35.8|8.2|0.0055
73843815|NCT02958865|147235192|SUPERIORITY||Mean Difference (Final Values)|23.4||||0.0055|TWO_SIDED|90.0|8.2|35.8|||Chan and Zhang method|||||35.8|8.2|0.0055
73843816|NCT02958865|147235193|SUPERIORITY||Mean Difference (Final Values)|21.6||||0.0111|TWO_SIDED|90.0|5.6|33.2|||Chan and Zhang method|||||33.2|5.6|0.0111
73843817|NCT02958865|147235193|SUPERIORITY||Mean Difference (Final Values)|34.7||||0.0006|TWO_SIDED|90.0|20.2|47.4|||Chan and Zhang method|||||47.4|20.2|0.0006
73843818|NCT02958865|147235193|SUPERIORITY||Mean Difference (Final Values)|42.0||||0.0001|TWO_SIDED|90.0|29.5|54.6|||Chan and Zhang Method|||||54.6|29.5|0.0001
73843819|NCT02958865|147235193|SUPERIORITY||Mean Difference (Final Values)|20.8||||0.0101|TWO_SIDED|90.0|5.6|33.0|||Chan and Zhang method|||||33.0|5.6|0.0101
73843820|NCT02958865|147235193|SUPERIORITY||Mean Difference (Final Values)|31.9||||0.0014|TWO_SIDED|90.0|17.0|44.8|||Chan and Zhang method|||||44.8|17.0|0.0014
73843821|NCT02958865|147235193|SUPERIORITY||Mean Difference (Final Values)|29.8||||0.0015|TWO_SIDED|90.0|17.0|42.6|||Chan and Zhang method|||||42.6|17.0|0.0015
73843822|NCT02958865|147235194|SUPERIORITY||Mean Difference (Final Values)|17.2||||0.0788|TWO_SIDED|90.0|-3.4|34.4|||Chan and Zhang method|||||34.4|-3.4|0.0788
74084291|NCT01525628|147721697|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|63.75|STANDARD_DEVIATION|17.3||0.9988|TWO_SIDED|90.0|57.19|71.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||71.07|57.19|0.9988
73843823|NCT02958865|147235194|SUPERIORITY||Mean Difference (Final Values)|45.4||||0.0002|TWO_SIDED|90.0|23.6|62.1|||Chan and Zhang method|||||62.1|23.6|0.0002
73843824|NCT02958865|147235194|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.0003|TWO_SIDED|90.0|23.5|60.5|||Chan and Zhang Method|||||60.5|23.5|0.0003
73843825|NCT02958865|147235194|SUPERIORITY||Mean Difference (Final Values)|17.7||||0.0773|TWO_SIDED|90.0|-4.0|35.1|||Chan and Zhang method|||||35.1|-4.0|0.0773
73843826|NCT02958865|147235194|SUPERIORITY||Mean Difference (Final Values)|29.2||||0.0136|TWO_SIDED|90.0|5.6|47.0|||Chan and Zhang method|||||47.0|5.6|0.0136
73843827|NCT02958865|147235194|SUPERIORITY||Mean Difference (Final Values)|37.7||||0.0015|TWO_SIDED|90.0|13.9|54.7|||Chan and Zhang method|||||54.7|13.9|0.0015
73843828|NCT02958865|147235195|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.2259|TWO_SIDED|90.0|-6.5|11.8|||Chan and Zhang method|||||11.8|-6.5|0.2259
73843829|NCT02958865|147235195|SUPERIORITY||Mean Difference (Final Values)|8.2||||0.082|TWO_SIDED|90.0|-3.8|17.7|||Chan and Zhang method|||||17.7|-3.8|0.0820
73843830|NCT02958865|147235195|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.0649|TWO_SIDED|90.0|-0.7|22.3|||Chan and Zhang Method|||||22.3|-0.7|0.0649
73843831|NCT02958865|147235195|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3777|TWO_SIDED|90.0|-8.6|9.7|||Chan and Zhang method|||||9.7|-8.6|0.3777
73843832|NCT02958865|147235195|SUPERIORITY||Mean Difference (Final Values)|17.0||||0.0212|TWO_SIDED|90.0|2.9|28.6|||Chan and Zhang method|||||28.6|2.9|0.0212
73843833|NCT02958865|147235195|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.0742|TWO_SIDED|90.0|-4.2|18.4|||Chan and Zhang method|||||18.4|-4.2|0.0742
73843834|NCT02958865|147235196|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.0872|TWO_SIDED|90.0|-3.4|17.1|||Chan and Zhang method|||||17.1|-3.4|0.0872
73843835|NCT02958865|147235196|SUPERIORITY||Mean Difference (Final Values)|16.3||||0.0254|TWO_SIDED|90.0|3.0|27.5|||Chan and Zhang method|||||27.5|3.0|0.0254
73843836|NCT02958865|147235196|SUPERIORITY||Mean Difference (Final Values)|26.0||||0.0034|TWO_SIDED|90.0|11.0|38.1|||Chan and Zhang Method|||||38.1|11.0|0.0034
73843837|NCT02958865|147235196|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.1565|TWO_SIDED|90.0|-4.5|15.4|||Chan and Zhang method|||||15.4|-4.5|0.1565
73843838|NCT02958865|147235196|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
73843839|NCT02958865|147235196|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
73843840|NCT02958865|147235197|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.2259|TWO_SIDED|90.0|-6.5|11.8|||Chan and Zhang method|||||11.8|-6.5|0.2259
73843841|NCT02958865|147235197|SUPERIORITY||Mean Difference (Final Values)|8.2||||0.082|TWO_SIDED|90.0|-3.8|17.7|||Chan and Zhang method|||||17.7|-3.8|0.0820
73843842|NCT02958865|147235197|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.0649|TWO_SIDED|90.0|-0.7|22.3|||Chan and Zhang Method|||||22.3|-0.7|0.0649
73843843|NCT02958865|147235197|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-11.3|6.1|||Chan and Zhang method|||||6.1|-11.3|1.0000
73843844|NCT02958865|147235197|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
73843845|NCT02958865|147235197|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.1593|TWO_SIDED|90.0|-4.4|15.7|||Chan and Zhang method|||||15.7|-4.4|0.1593
73843846|NCT02329587|147235216|OTHER||Between-group effect size (Hedge's g)|0.138|||||TWO_SIDED|||||||||||||
73843847|NCT02329587|147235217|OTHER||Between-group effect size (Hedge's g)|-0.214|||||TWO_SIDED|||||||||||||
73843848|NCT02329587|147235218|OTHER||Between-groups effect size (Hedge's g)|-0.007|||||TWO_SIDED|||||||||||||
73843849|NCT02329587|147235219|OTHER||Between-group effect size (Hedge's g)|-0.151|||||TWO_SIDED|||||||||||||
73843850|NCT02329587|147235220|OTHER||Between-groups effect size (Hedge's g)|0.704|||||TWO_SIDED|||||||||||||
73843851|NCT02329587|147235221|OTHER||Odds Ratio (OR)|1.125|||||TWO_SIDED|||||||||||||
73843852|NCT01728246|147235222|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73843853|NCT01728246|147235223|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73843854|NCT01728246|147235225|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73898530|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.132||0.121|TWO_SIDED|95.0|-0.465|0.055||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.055|-0.465|0.121
74022444|NCT01431287|147597110|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.647|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.925|0.370|<0.0001
73843855|NCT01983111|147235228|NON_INFERIORITY_OR_EQUIVALENCE|In the PP set, for a non-inferiority test of the reduction in the pain intensity score from Visit 1 (Baseline) to Week 6 of treatment, the lower limit of the 97.5% onesided confidence interval was compared to a clinical non-inferiority margin, -1.5.|Mean Difference (Final Values)|-0.43|STANDARD_DEVIATION|1.79||0.2658|TWO_SIDED|97.5|-6.0|3.0|||t-test, 2 sided|||In the Per protocol set||3|-6|0.2658
73843856|NCT04380142|147235270|SUPERIORITY||Least Squares (LS) Mean of Difference|1.75|STANDARD_ERROR_OF_MEAN|0.65||0.0083|TWO_SIDED|95.0|0.46|3.05||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||3.05|0.46|0.0083
73843857|NCT04380142|147235271|SUPERIORITY||LS Mean of Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.63||0.0054|TWO_SIDED|95.0|-3.03|-0.54||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||-0.54|-3.03|0.0054
73843858|NCT04380142|147235272|SUPERIORITY||LS Mean of Difference|-1.58|STANDARD_ERROR_OF_MEAN|1.05||0.1318|TWO_SIDED|95.0|-3.65|0.48||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||0.48|-3.65|0.1318
73843859|NCT04380142|147235273|SUPERIORITY||Odds Ratio (OR)|0.12|STANDARD_ERROR_OF_MEAN|0.49|<=|0.001|TWO_SIDED|95.0|0.04|0.31||The generalized linear mixed model: status = treatment country visit baseline treatment\*visit. The unstructured variance-covariance structure is used.|generalized linear mixed model|||||0.31|0.04|<=0.001
73843860|NCT04380142|147235274|SUPERIORITY||Odds Ratio (OR)|1.81|STANDARD_ERROR_OF_MEAN|0.68||0.0091|TWO_SIDED|95.0|0.46|3.16|||generalized linear mixed model|||||3.16|0.46|0.0091
73843861|NCT04380142|147235275|SUPERIORITY||LS Mean of Difference|-5.4|STANDARD_ERROR_OF_MEAN|1.32|<=|0.001|TWO_SIDED|95.0|-8.03|-2.78||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||-2.78|-8.03|<=0.001
73843862|NCT04380142|147235276|SUPERIORITY||Least Squares (LS) Mean of Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.04||0.047|TWO_SIDED|95.0|-8.14|-0.05||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||-0.05|-8.14|0.0470
73843863|NCT04380142|147235277|SUPERIORITY||LS Mean of Difference|0.049|STANDARD_ERROR_OF_MEAN|0.025||0.0566|TWO_SIDED|95.0|-0.001|0.1||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||0.100|-0.001|0.0566
73843864|NCT04380142|147235278|SUPERIORITY||LS Mean of Difference|1.72|STANDARD_ERROR_OF_MEAN|0.72||0.0184|TWO_SIDED|95.0|0.3|3.15||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||3.15|0.30|0.0184
73843865|NCT04380142|147235279|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.69||0.7989|TWO_SIDED|95.0|-1.2|1.55||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.55|-1.20|0.7989
73843866|NCT04380142|147235280|SUPERIORITY||LS Mean of Difference|-2.73|STANDARD_ERROR_OF_MEAN|1.96||0.1656|TWO_SIDED|95.0|-6.61|1.15||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.15|-6.61|0.1656
73843867|NCT04380142|147235281|SUPERIORITY||LS Mean of Difference|-5.49|STANDARD_ERROR_OF_MEAN|3.65||0.1347|TWO_SIDED|95.0|-12.71|1.73||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.73|-12.71|0.1347
73843868|NCT04537650|147235303|SUPERIORITY||Odds Ratio (OR)|21.0|||<|0.001|TWO_SIDED|95.0|1.8|243.24|||Chi-squared|||||243.24|1.8|<0.001
73843869|NCT04537650|147235304|SUPERIORITY||Odds Ratio (OR)|45.0|||<|0.001|TWO_SIDED|95.0|4.15|487.5|||Chi-squared|||||487.5|4.15|<0.001
73843870|NCT00879398|147235322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
73843871|NCT00879398|147235323|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
73843872|NCT00879398|147235324|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
73843873|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||0.1319||95.0||||Statistical significant level: 0.05|Chi-squared|||Geriatric Status: \<65 years versus (vs) Geriatric Status: ≥65 years||||0.1319
73843874|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age Categories: \<50 years, 50 to 59 years, 60 to 69 years, 70 to 79 years, and ≥80 years.||||0.6010
73843875|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||0.0289||95.0||||Statistical significant level: 0.05|Chi-squared|||Male vs Female||||0.0289
73843876|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||0.3078||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Weight Categories: \<50 kg, 50 to 60 kg, 60 to 70 kg, and ≥70 kg.||||0.3078
73843877|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||0.9614||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Height Categories: \<160 cm, 160 to 170 cm, and ≥170 cm.||||0.9614
73843878|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||0.0788||95.0||||Statistical significant level: 0.05|Fisher Exact|||Allergic History: Yes vs Allergic History: No||||0.0788
73843879|NCT00879398|147235326|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Duration of Disease: \<1 week, 1 to 8 weeks, 8 to 16 weeks, and ≥16 weeks.||||<0.0001
73843880|NCT00879398|147235326|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Past OAB Treatment History: Yes vs Past OAB Treatment History: No||||<0.0001
73843881|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||0.1147||95.0||||Statistical significant level: 0.05|Chi-squared|||Medical History of Past Disease: Yes vs Medical History of Past Disease: No||||0.1147
73843882|NCT00879398|147235326|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Medical History of Present Disease: Yes vs Medical History of Present Disease: No||||<0.0001
73843883|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||1||95.0||||Statistical significant level: 0.05|Fisher Exact|||Kidney Disorder: Yes vs Kidney Disorder: No||||1.0000
73843884|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||1||95.0||||Statistical significant level: 0.05|Fisher Exact|||Liver Disorder: Yes vs Liver Disorder: No||||1.0000
73843885|NCT00879398|147235326|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Total Administration Period of Toviaz Subgroups: \<2 months, 2 to 4 months, and ≥4 months.||||<0.0001
73843886|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||0.0239||95.0||||Statistical significant level: 0.05|Fisher Exact|||Comparison among Daily Dose of Toviaz: 3 mg, 4 mg, \>4 mg to \<8 mg, and 8 mg.||||0.0239
73843887|NCT00879398|147235326|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Completion vs Discontinuation||||<0.0001
73843888|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||0.5889||95.0||||Statistical significant level: 0.05|Fisher Exact|||Total Administration Period \<274 days vs Total Administration Period ≥ 274 days||||0.5889
73843889|NCT00879398|147235326|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical significant level: 0.05|Chi-squared|||Concurrent Medication: Yes vs Concurrent Medication: No||||0.0010
73843890|NCT01380080|147235341|SUPERIORITY_OR_OTHER_LEGACY||Cumulative probability difference|-0.06||||0.97|TWO_SIDED|95.0|-3.05|2.94|||z-test|||Treatment comparison was made using the difference (arm B- arm A) in the Kaplan-Meier estimate for 24 week cumulative probability of death or unknown vital status with 95% confidence interval||2.94|-3.05|0.97
74084292|NCT01525628|147721698|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|144.78|STANDARD_DEVIATION|19.0||0.9749|TWO_SIDED|90.0|128.3|163.36|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||163.36|128.30|0.9749
73843891|NCT04251533|147235357|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.92|2.41|||Regression, Cox|||||2.41|0.92|
73843892|NCT06378008|147235376|SUPERIORITY||Adjusted Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-1.98|-1.62|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 56||-1.62|-1.98|<0.0001
73843893|NCT06378008|147235377|SUPERIORITY||Adjusted Mean Difference|52.87|STANDARD_ERROR_OF_MEAN|2.428|<|0.0001|TWO_SIDED|95.0|48.08|57.65|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 56||57.65|48.08|<0.0001
73843894|NCT06378008|147235378|SUPERIORITY||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.053||0.0005|TWO_SIDED|95.0|-0.29|-0.08|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 3||-0.08|-0.29|0.0005
73959869|NCT01924767|147454971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|91306.96|||<|0.0001|TWO_SIDED|95.0|64685.41|117928.5||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo was calculated|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||117928.5|64685.41|<0.0001
73843895|NCT06378008|147235378|SUPERIORITY||Adjusted Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.73|-0.49|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 7||-0.49|-0.73|<0.0001
73843896|NCT06378008|147235378|SUPERIORITY||Adjusted Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-1.41|-1.04|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 14||-1.04|-1.41|<0.0001
73843897|NCT06378008|147235378|SUPERIORITY||Adjusted Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|-1.74|-1.38|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 28||-1.38|-1.74|<0.0001
73843898|NCT06378008|147235379|SUPERIORITY||Adjusted Mean Difference|7.14|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|5.75|8.53|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 3||8.53|5.75|<0.0001
73843899|NCT06378008|147235379|SUPERIORITY||Adjusted Mean Difference|14.4|STANDARD_ERROR_OF_MEAN|1.112|<|0.0001|TWO_SIDED|95.0|12.2|16.59|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 7||16.59|12.20|<0.0001
73843900|NCT06378008|147235379|SUPERIORITY||Adjusted Mean Difference|25.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.0001|TWO_SIDED|95.0|22.67|28.93|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 14||28.93|22.67|<0.0001
73843901|NCT06378008|147235379|SUPERIORITY||Adjusted Mean Difference|40.99|STANDARD_ERROR_OF_MEAN|2.254|<|0.0001|TWO_SIDED|95.0|36.55|45.43|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 28||45.43|36.55|<0.0001
73843902|NCT06378008|147235380|SUPERIORITY||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.219||0.3489|TWO_SIDED|95.0|-0.64|0.23|||Mixed Model with Repeated Measures||Adjusted Mean Difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 28||0.23|-0.64|0.3489
73843903|NCT06378008|147235380|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.267||0.0876|TWO_SIDED|95.0|-0.98|0.07|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 56||0.07|-0.98|0.0876
73843904|NCT06378008|147235380|SUPERIORITY||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.252||0.9108|TWO_SIDED|95.0|-0.47|0.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 28||0.52|-0.47|0.9108
73843905|NCT06378008|147235380|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.281||0.4854|TWO_SIDED|95.0|-0.75|0.36|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 56||0.36|-0.75|0.4854
73843906|NCT06378008|147235380|SUPERIORITY||Adjusted Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.261||0.8309|TWO_SIDED|95.0|-0.46|0.57|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 28||0.57|-0.46|0.8309
73843907|NCT06378008|147235380|SUPERIORITY||Adjusted Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.297||0.05|TWO_SIDED|95.0|-1.17|0.0|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 56||-0.00|-1.17|0.0500
73843908|NCT06378008|147235381|SUPERIORITY||Adjusted Mean Difference|-2.27|STANDARD_ERROR_OF_MEAN|3.859||0.5565|TWO_SIDED|95.0|-9.88|5.33|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||5.33|-9.88|0.5565
73843909|NCT06378008|147235381|SUPERIORITY||Adjusted Mean Difference|-5.96|STANDARD_ERROR_OF_MEAN|4.715||0.2078|TWO_SIDED|95.0|-15.25|3.34|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||3.34|-15.25|0.2078
73843910|NCT06378008|147235382|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.588||0.5597|TWO_SIDED|95.0|-1.5|0.82|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.82|-1.50|0.5597
73843911|NCT06378008|147235382|SUPERIORITY||Adjusted Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.705||0.4627|TWO_SIDED|95.0|-1.91|0.87|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.87|-1.91|0.4627
73843912|NCT06378008|147235383|SUPERIORITY||Adjusted Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|1.583||0.3|TWO_SIDED|95.0|-4.77|1.48|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.48|-4.77|0.3000
73843913|NCT06378008|147235383|SUPERIORITY||Adjusted Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.958||0.1974|TWO_SIDED|95.0|-6.39|1.33|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||1.33|-6.39|0.1974
73843914|NCT06378008|147235384|SUPERIORITY||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.679||0.9203|TWO_SIDED|95.0|-1.27|1.41|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.41|-1.27|0.9203
73843915|NCT06378008|147235384|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.717||0.2489|TWO_SIDED|95.0|-2.24|0.58|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.58|-2.24|0.2489
73843916|NCT06378008|147235385|SUPERIORITY||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|1.09||0.8496|TWO_SIDED|95.0|-2.36|1.94|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.94|-2.36|0.8496
73843917|NCT06378008|147235385|SUPERIORITY||Adjusted Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|1.226||0.1596|TWO_SIDED|95.0|-4.15|0.69|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.69|-4.15|0.1596
73843918|NCT06378008|147235386|SUPERIORITY||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.697||0.9577|TWO_SIDED|95.0|-1.34|1.41|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.41|-1.34|0.9577
73843919|NCT06378008|147235386|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.748||0.8261|TWO_SIDED|95.0|-1.64|1.31|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||1.31|-1.64|0.8261
73843920|NCT06378008|147235387|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.089||0.8895|TWO_SIDED|95.0|-0.19|0.16|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.16|-0.19|0.8895
73843921|NCT06378008|147235387|SUPERIORITY||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.101||0.8083|TWO_SIDED|95.0|-0.17|0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.22|-0.17|0.8083
73843922|NCT06378008|147235388|SUPERIORITY||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.351||0.7362|TWO_SIDED|95.0|-0.57|0.81|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.81|-0.57|0.7362
73843923|NCT06378008|147235388|SUPERIORITY||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.39||0.5568|TWO_SIDED|95.0|-1.0|0.54|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.54|-1.00|0.5568
73843924|NCT00210132|147235389|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of proportions.||||0.99
73843925|NCT00210132|147235390|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
73863240|NCT01943552|147272666|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel Test Statistic|1.82||||0.1779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||For main post-operative pulmonary complications, the Cochran-Mantel-Haenszel analysis was performed on the SCS. Mantel-Haenszel test with strata based on acute bronchodilator responsiveness at baseline and age was used to compare the number of patients with main post-operative pulmonary complications between the two arms.||||0.1779
73843926|NCT00375713|147235394|NON_INFERIORITY_OR_EQUIVALENCE|The pre-set threshold for non inferiority is -10%.|Difference in proportion of responders|0.00069213||||||95.0|-0.0875|0.0888||||||The lower bound of the 95% two sided confidence interval for the difference (Levocetirizine - Cetirizine) in percentage of responders is compared to the pre-set threshold for non inferiority (-10% which is equal to -0.1 for the proportion of responders). Standard method for estimation of the difference in proportions incl. confidence interval using normal approximation is used.||0.0888|-0.0875|
73843927|NCT00375713|147235395|SUPERIORITY_OR_OTHER|||||||0.4369||95.0|||||ANCOVA|Pruritus score is adjusted on pruritus Baseline score.||The mean daily pruritus score at Day 14 visit or at study completion was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor||||0.4369
73843928|NCT00375713|147235396|SUPERIORITY_OR_OTHER|||||||0.3549||95.0|||||ANCOVA|pruritus severity score at baseline has been used as a covariate.||The categorized duration of Pruritus at endpoint during the 14 day treatment period was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor.||||0.3549
73843929|NCT00375713|147235397|SUPERIORITY_OR_OTHER|||||||0.7518||95.0|||||Cochran-Mantel-Haenszel|stratified on the prurity severity score at the previous day of randomization.||||||0.7518
73843930|NCT03211416|147235401|SUPERIORITY||Response Rate|0.296|||||TWO_SIDED|95.0|0.151|0.483||||||||0.483|0.151|
73843931|NCT03211416|147235404|SUPERIORITY|||||||0.4||||||Significance level of 0.05.|Two-sided, one-sample t-test|||The null hypothesis is that the mean ratio of T effect cells (post / pre) is equal to 1 (no change).||||0.40
73843932|NCT04604431|147235428|SUPERIORITY||Odds Ratio (OR)|14.1|||<|0.001|TWO_SIDED|95.0|6.9|29.1|||Mixed Models Analysis|||Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for low-risk infants.||29.1|6.9|<0.001
73843933|NCT04604431|147235428|SUPERIORITY||Odds Ratio (OR)|3.1||||0.034|TWO_SIDED|95.0|1.1|8.8|||Mixed Models Analysis|||Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for high-risk infants.||8.8|1.1|0.034
73843934|NCT00643279|147235433|SUPERIORITY|Survival estimate at 6-months|6-month survival rate|91.5|||||ONE_SIDED|95.0|88.7||||||||||88.7|
73843935|NCT00643279|147235434|SUPERIORITY|Survival estimate at 6-months|6-month survival rate|100.0|||||ONE_SIDED|95.0|98.9||||||||||98.9|
73843936|NCT05715827|147235442|OTHER|The study used descriptive statistics and 95% confidence intervals to summarize data. The sample size of 40 patients (20 per surgery type) was based on prior studies with 3% device malfunction and 0.9% failure-related conversion rates. The primary endpoint was the completion rate, defined as ≥95% without conversion due to system issues or major complications within 24 hours. The Full Analysis Set included all subjects who started the procedure. No interim analyses were planned.|Completion rate|97.5|||||TWO_SIDED|95.0|86.8|99.9||The study used descriptive statistics and confidence intervals, not hypothesis testing with p-values. The main goal was to confirm the completion rate met or exceeded 95% and present a 95% confidence interval||The main goal was to confirm the completion rate met or exceeded 95% with a 95% confidence interval.|Estimated Value of 97.5% is an overall completion rate|The study aimed to confirm the Medtronic Hugo™ RAS System's performance for prostatectomy or cholecystectomy, targeting a 95% completion rate (no conversion due to system issues or major complications within 24 hours). The Full Analysis Set (FAS) included all subjects starting the procedure. Descriptive statistics and 95% confidence intervals were used to assess primary and secondary endpoints, confirming safety and effectiveness.|Descriptive Analysis was used|99.9|86.8|
73843937|NCT05715827|147235443|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Overall Complication Rate|20.0|||||TWO_SIDED|95.0|9.1|35.6||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||35.6|9.1|
73843938|NCT05715827|147235444|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Major complication rate|5.0|||||TWO_SIDED|95.0|0.6|16.9||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||16.9|0.6|
73959870|NCT01924767|147454972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.456||||0.0449|TWO_SIDED|95.0|-30.543|-0.369||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-0.369|-30.543|0.0449
73898531|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|1.05|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73959871|NCT01924767|147454972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.467||||0.0042|TWO_SIDED|95.0|-39.085|-7.848||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-7.848|-39.085|0.0042
73959872|NCT01924767|147454972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.956||||0.0521|TWO_SIDED|95.0|-30.057|0.145||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||0.145|-30.057|0.0521
73843939|NCT05715827|147235445|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Readmission rate|10.0|||||TWO_SIDED|95.0|2.8|23.7||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||23.7|2.8|
73843940|NCT05715827|147235446|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Reoperation rate|0.0|||||TWO_SIDED|||||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||||
73843941|NCT05715827|147235447|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Device deficiency rate|32.5|||||TWO_SIDED|95.0|18.6|49.1||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||49.1|18.6|
73843942|NCT03021486|147235455|OTHER|||||||0.71|||||||Wilcoxon Rank Sum Test|||||||0.71
73843943|NCT03021486|147235457|OTHER|||||||0.86|||||||Wilcoxon Rank Sum Test|||||||0.86
73843944|NCT03021486|147235458|OTHER|||||||0.12|||||||Two-tailed Fisher's exact test|||||||0.12
73843945|NCT03021486|147235459|OTHER|||||||0.007|||||||Two-tailed Fisher's exact test|||||||0.007
73843946|NCT03021486|147235460|OTHER|||||||0.83|||||||Two-tailed Fisher's exact test|||Perceived Comfort level as assessed by caregiver||||0.83
73843947|NCT03021486|147235460|OTHER|||||||0.82|||||||Two-tailed Fisher's exact test|||Perceived agitation level as assessed by caregiver||||0.82
74022445|NCT01431287|147597110|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.322|STANDARD_ERROR_OF_MEAN|0.141||0.0226|TWO_SIDED|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.600|0.045|0.0226
73843948|NCT03021486|147235461|OTHER|||||||0.82|||||||Two-tailed Fisher's exact test|||Perceived Comfort level as assessed by nurse||||0.82
74022446|NCT01431287|147597110|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.371|STANDARD_ERROR_OF_MEAN|0.142||0.0089|TWO_SIDED|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.649|0.093|0.0089
73843949|NCT03021486|147235461|OTHER|||||||0.91|||||||Two-tailed Fisher's exact test|||Perceived agitation level as assessed by nurse||||0.91
73843950|NCT03021486|147235462|OTHER|||||||0.12|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to time - frequency||||0.12
73843951|NCT03021486|147235462|OTHER|||||||0.07|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to place - frequency||||0.07
73843952|NCT03021486|147235462|OTHER|||||||0.051|||||||Wilcoxon Rank Sum Test|||Nursing assessment, visual hallucination - frequency||||0.051
73843953|NCT03021486|147235462|OTHER|||||||0.048|||||||Wilcoxon Rank Sum Test|||Nursing assessment, tactile hallucination - frequency||||0.048
73843954|NCT03021486|147235462|OTHER|||||||0.15|||||||Wilcoxon Rank Sum Test|||Nursing assessment, auditory hallucination - frequency||||0.15
73843955|NCT03021486|147235462|OTHER|||||||0.1|||||||Wilcoxon Rank Sum Test|||Nursing assessment, delusional thoughts - frequency||||0.10
73843956|NCT03021486|147235462|OTHER|||||||0.15|||||||Wilcoxon Rank Sum Test|||Nursing assessment, psychomotor agitation- frequency||||0.15
73843957|NCT03021486|147235462|OTHER|||||||0.98|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to time - distress||||0.98
73843958|NCT03021486|147235462|OTHER|||||||0.93|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to place - distress||||0.93
73843959|NCT03021486|147235462|OTHER|||||||0.08|||||||Wilcoxon Rank Sum Test|||Nursing assessment, visual hallucination - distress||||0.08
73843960|NCT03021486|147235462|OTHER|||||||0.28|||||||Wilcoxon Rank Sum Test|||Nursing assessment, tactile hallucination - distress||||0.28
73843961|NCT03021486|147235462|OTHER|||||||0.83|||||||Wilcoxon Rank Sum Test|||Nursing assessment, auditory hallucination - distress||||0.83
74022447|NCT01431287|147597110|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.332|STANDARD_ERROR_OF_MEAN|0.141||0.0186|TWO_SIDED|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.609|0.056|0.0186
73843962|NCT03021486|147235462|OTHER|||||||0.22|||||||Wilcoxon Rank Sum Test|||Nursing assessment, delusional thoughts - distress||||0.22
74084293|NCT01525628|147721698|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|152.94|STANDARD_DEVIATION|26.8||0.9703|TWO_SIDED|90.0|128.6|181.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||181.89|128.60|0.9703
73843963|NCT03021486|147235462|OTHER|||||||0.75|||||||Wilcoxon Rank Sum Test|||Nursing assessment, psychomotor agitation - distress||||0.75
73843964|NCT03021486|147235463|OTHER|||||||0.09|||||||Wilcoxon Rank Sum Test|||||||0.09
73843965|NCT03021486|147235464|OTHER|||||||0.02|||||||Wilcoxon Rank Sum Test|||Mean change in pain.||||0.02
73843966|NCT03021486|147235464|OTHER|||||||0.1|||||||Wilcoxon Rank Sum Test|||Mean change in Fatigue.||||0.10
73843967|NCT03021486|147235464|OTHER|||||||0.02|||||||Wilcoxon Rank Sum Test|||Mean change in Nausea.||||0.02
73843968|NCT03021486|147235464|OTHER|||||||0.97|||||||Wilcoxon Rank Sum Test|||Mean change in Depression.||||0.97
73843969|NCT03021486|147235464|OTHER|||||||0.03|||||||Wilcoxon Rank Sum Test|||Mean change in Anxiety.||||0.03
73843970|NCT03021486|147235464|OTHER|||||||0.68|||||||Wilcoxon Rank Sum Test|||Mean change in Drowsiness.||||0.68
73843971|NCT03021486|147235464|OTHER|||||||0.8|||||||Wilcoxon Rank Sum Test|||Mean change in Appetite.||||0.80
73843972|NCT03021486|147235464|OTHER|||||||0.45|||||||Wilcoxon Rank Sum Test|||Mean change in Feeling of well being.||||0.45
73959873|NCT01924767|147454972|SUPERIORITY_OR_OTHER||Difference to placebo|-10.602||||0.1676|TWO_SIDED|95.0|-25.848|4.644||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||4.644|-25.848|0.1676
73843973|NCT03021486|147235464|OTHER|||||||0.16|||||||Wilcoxon Rank Sum Test|||Mean change in Shortness of breath.||||0.16
73843974|NCT03021486|147235464|OTHER|||||||0.12|||||||Wilcoxon Rank Sum Test|||Mean change in Sleep.||||0.12
73843975|NCT04887831|147235467|OTHER||Adjusted percentage difference|-0.101|STANDARD_ERROR_OF_MEAN|0.1052||0.34|TWO_SIDED|95.0|-0.308|0.105||The 2-sided p-value was calculated using stratified CMH method to account for the presence of visceral metastasis (yes/no) and initial chemotherapy type (cisplatin/carboplatin) as the stratification factors.|Cochran-Mantel-Haenszel|||||0.105|-0.308|0.340
73843976|NCT04887831|147235468|OTHER||Adjusted percentage difference|-0.008|STANDARD_ERROR_OF_MEAN|0.1078||0.938|TWO_SIDED|95.0|-0.22|0.203||The 2-sided p-value was calculated using stratified CMH method to account for the presence of visceral metastasis (yes/no) and initial chemotherapy type (cisplatin/carboplatin) as the stratification factors.|Cochran-Mantel-Haenszel|||||0.203|-0.220|0.938
73959874|NCT01924767|147454973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.269||||0.2239|TWO_SIDED|95.0|-19.162|4.624||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||4.624|-19.162|0.2239
73843977|NCT03674281|147235503|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
73843978|NCT03674281|147235503|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73843979|NCT01690273|147235531|SUPERIORITY_OR_OTHER|||||||0.13|||||||Mixed Models Analysis|||||||0.13
73843980|NCT01690273|147235531|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
73843981|NCT01690273|147235531|SUPERIORITY_OR_OTHER|||||||0.11|||||||Mixed Models Analysis|||||||0.11
73843982|NCT01690273|147235531|SUPERIORITY_OR_OTHER|||||||0.9913|||||||Mixed Models Analysis|||||||0.9913
73843983|NCT01690273|147235531|SUPERIORITY_OR_OTHER|||||||0.0427|||||||Mixed Models Analysis|||||||0.0427
73843984|NCT01690273|147235531|SUPERIORITY_OR_OTHER|||||||0.1856|||||||Mixed Models Analysis|||||||0.1856
73843985|NCT01690273|147235532|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||0.04
73843986|NCT01690273|147235532|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
73843987|NCT01690273|147235532|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
73843988|NCT01690273|147235532|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
73843989|NCT01690273|147235532|SUPERIORITY_OR_OTHER|||||||0.935|||||||Mixed Models Analysis|||||||0.935
73843990|NCT01690273|147235532|SUPERIORITY_OR_OTHER|||||||0.876|||||||Mixed Models Analysis|||||||0.876
73843991|NCT01690273|147235533|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
73843992|NCT01690273|147235533|SUPERIORITY_OR_OTHER|||||||0.87|||||||Mixed Models Analysis|||||||0.87
73843993|NCT01690273|147235533|SUPERIORITY_OR_OTHER|||||||0.83|||||||Mixed Models Analysis|||||||0.83
73843994|NCT01690273|147235533|SUPERIORITY_OR_OTHER|||||||0.989|||||||Mixed Models Analysis|||||||0.989
73843995|NCT01690273|147235533|SUPERIORITY_OR_OTHER|||||||0.022|||||||Mixed Models Analysis|||||||0.022
73843996|NCT01690273|147235533|SUPERIORITY_OR_OTHER|||||||0.119|||||||Mixed Models Analysis|||||||0.119
73843997|NCT01690273|147235534|SUPERIORITY_OR_OTHER|||||||0.09|||||||Mixed Models Analysis|||||||0.09
73843998|NCT01690273|147235534|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
73843999|NCT01690273|147235534|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||||||0.94
73844000|NCT01690273|147235534|SUPERIORITY_OR_OTHER|||||||0.213|||||||Mixed Models Analysis|||||||0.213
73844001|NCT01690273|147235534|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||0.007
73844002|NCT01690273|147235534|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.900
73844003|NCT01690273|147235535|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||||||0.003
73844004|NCT01690273|147235535|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
73844005|NCT01690273|147235535|SUPERIORITY_OR_OTHER|||||||0.69|||||||Mixed Models Analysis|||||||0.69
73844006|NCT01690273|147235535|SUPERIORITY_OR_OTHER|||||||0.874|||||||Mixed Models Analysis|||||||0.874
73844007|NCT01690273|147235535|SUPERIORITY_OR_OTHER|||||||0.057|||||||Mixed Models Analysis|||||||0.057
73844008|NCT01690273|147235535|SUPERIORITY_OR_OTHER|||||||0.526|||||||Mixed Models Analysis|||||||0.526
73844009|NCT01690273|147235536|SUPERIORITY_OR_OTHER|||||||0.853|||||||Mixed Models Analysis|||||||0.853
73844010|NCT01690273|147235536|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
73844011|NCT01690273|147235536|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
73844012|NCT01690273|147235536|SUPERIORITY_OR_OTHER|||||||0.889|||||||Mixed Models Analysis|||||||0.889
73844013|NCT01690273|147235536|SUPERIORITY_OR_OTHER|||||||0.098|||||||Mixed Models Analysis|||||||0.098
73844014|NCT01690273|147235536|SUPERIORITY_OR_OTHER|||||||0.645|||||||Mixed Models Analysis|||||||0.645
73844015|NCT01690273|147235537|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||0.07
74084294|NCT01525628|147721698|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|102.99|STANDARD_DEVIATION|29.3||0.05|TWO_SIDED|90.0|84.85|124.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||124.99|84.85|0.0500
73844016|NCT01690273|147235537|SUPERIORITY_OR_OTHER|||||||0.13|||||||Mixed Models Analysis|||||||0.13
73844017|NCT01690273|147235537|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
73844018|NCT01690273|147235537|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
73844019|NCT01690273|147235537|SUPERIORITY_OR_OTHER|||||||0.338|||||||Mixed Models Analysis|||||||0.338
73844020|NCT01690273|147235537|SUPERIORITY_OR_OTHER|||||||0.476|||||||Mixed Models Analysis|||||||0.476
73844021|NCT01690273|147235538|SUPERIORITY_OR_OTHER|||||||0.88|||||||Mixed Models Analysis|||||||0.88
73844022|NCT01690273|147235538|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
73844023|NCT01690273|147235538|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
73844024|NCT01690273|147235538|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
73844025|NCT01690273|147235538|SUPERIORITY_OR_OTHER|||||||0.995|||||||Mixed Models Analysis|||||||0.995
73844026|NCT01690273|147235538|SUPERIORITY_OR_OTHER|||||||0.985|||||||Mixed Models Analysis|||||||0.985
73844027|NCT01690273|147235539|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.9
73844028|NCT01690273|147235539|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|||||||0.7
73844029|NCT01690273|147235539|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
73844030|NCT01690273|147235539|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
73844031|NCT01690273|147235539|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.900
73844032|NCT01690273|147235539|SUPERIORITY_OR_OTHER|||||||0.739|||||||Mixed Models Analysis|||||||0.739
73844033|NCT01690273|147235540|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
73844034|NCT01690273|147235540|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
73844035|NCT01690273|147235540|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mixed Models Analysis|||||||0.37
73844036|NCT01690273|147235540|SUPERIORITY_OR_OTHER|||||||0.618|||||||Mixed Models Analysis|||||||0.618
73844037|NCT01690273|147235540|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
73844038|NCT01690273|147235540|SUPERIORITY_OR_OTHER|||||||0.689|||||||Mixed Models Analysis|||||||0.689
73844039|NCT01690273|147235541|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||0.8
73844040|NCT01690273|147235541|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
73844041|NCT01690273|147235541|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
73844042|NCT01690273|147235541|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
73844043|NCT01690273|147235541|SUPERIORITY_OR_OTHER|||||||0.929|||||||Mixed Models Analysis|||||||0.929
73844044|NCT01690273|147235541|SUPERIORITY_OR_OTHER|||||||0.98|||||||Mixed Models Analysis|||||||0.980
73844045|NCT01690273|147235542|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
73844046|NCT01690273|147235542|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
73844047|NCT01690273|147235542|SUPERIORITY_OR_OTHER|||||||0.35|||||||Mixed Models Analysis|||||||0.350
73844048|NCT01690273|147235542|SUPERIORITY_OR_OTHER|||||||0.997|||||||Mixed Models Analysis|||||||0.997
73844049|NCT01690273|147235542|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.970
73844050|NCT01690273|147235542|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
73844051|NCT01690273|147235543|SUPERIORITY_OR_OTHER|||||||0.997|||||||Mixed Models Analysis|||||||0.997
73844052|NCT01690273|147235543|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
73844053|NCT01690273|147235543|SUPERIORITY_OR_OTHER|||||||0.503|||||||Mixed Models Analysis|||||||0.503
73844054|NCT01690273|147235543|SUPERIORITY_OR_OTHER|||||||0.814|||||||Mixed Models Analysis|||||||0.814
73844055|NCT01690273|147235543|SUPERIORITY_OR_OTHER|||||||0.643|||||||Mixed Models Analysis|||||||0.643
73844056|NCT01690273|147235543|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
73844057|NCT01690273|147235544|SUPERIORITY_OR_OTHER|||||||0.787|||||||Mixed Models Analysis|||||||0.787
73844058|NCT01690273|147235544|SUPERIORITY_OR_OTHER|||||||0.408|||||||Mixed Models Analysis|||||||0.408
73844059|NCT01690273|147235544|SUPERIORITY_OR_OTHER|||||||0.157|||||||Mixed Models Analysis|||||||0.157
73844060|NCT01690273|147235544|SUPERIORITY_OR_OTHER|||||||0.835|||||||Mixed Models Analysis|||||||0.835
73844061|NCT01690273|147235544|SUPERIORITY_OR_OTHER|||||||0.256|||||||Mixed Models Analysis|||||||0.256
73844062|NCT01690273|147235544|SUPERIORITY_OR_OTHER|||||||0.935|||||||Mixed Models Analysis|||||||0.935
73844063|NCT01690273|147235545|SUPERIORITY_OR_OTHER|||||||0.978|||||||Mixed Models Analysis|||||||0.978
73844064|NCT01690273|147235545|SUPERIORITY_OR_OTHER|||||||0.169|||||||Mixed Models Analysis|||||||0.169
73844065|NCT01690273|147235545|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
73844066|NCT01690273|147235545|SUPERIORITY_OR_OTHER|||||||0.993|||||||Mixed Models Analysis|||||||0.993
74084295|NCT01525628|147721698|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|124.22|STANDARD_DEVIATION|24.1||0.4697|TWO_SIDED|90.0|107.91|142.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||142.99|107.91|0.4697
73844067|NCT01690273|147235545|SUPERIORITY_OR_OTHER|||||||0.105|||||||Mixed Models Analysis|||||||0.105
73844068|NCT01690273|147235545|SUPERIORITY_OR_OTHER|||||||0.335|||||||Mixed Models Analysis|||||||0.335
73844069|NCT05093621|147235594|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Mortality at 1 year||||1.000
73844070|NCT05093621|147235595|SUPERIORITY|||||||0.729|||||||t-test, 2 sided|||||||0.729
73844071|NCT05093621|147235596|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.650
73844072|NCT05093621|147235597|SUPERIORITY|||||||0.873|||||||t-test, 2 sided|||||||0.873
73844073|NCT01664624|147235598|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|5.82||0.388|TWO_SIDED|95.0|-16.9|6.7||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and alogliptin alone.||6.7|-16.9|0.388
73844074|NCT01664624|147235598|SUPERIORITY_OR_OTHER||LS Mean Difference|22.7|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|11.1|34.3||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.||34.3|11.1|<0.001
73844075|NCT01664624|147235598|SUPERIORITY_OR_OTHER||LS Mean Difference|28.8|STANDARD_ERROR_OF_MEAN|5.76|<|0.001|TWO_SIDED|95.0|17.1|40.5||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.||40.5|17.1|<0.001
73844076|NCT01198587|147235639|SUPERIORITY|||||||0.88|||||||Log Rank|||||||0.88
73844077|NCT01198587|147235639|SUPERIORITY|||||||0.19|||||||Log Rank|||||||0.19
73844078|NCT04067011|147235662|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of AUC0-12h.|Ratio of AUC|0.9764|||||TWO_SIDED|90.0|0.8895|1.0718||||||Analysis of Geometric mean ratio of area under the curve from 0 to 12 hours (AUC0-12h) for ciprofloxacin on Days 8 and 35||1.0718|0.8895|
73844079|NCT04067011|147235662|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of Cmax.|Ratio of Cmax|0.9706|||||TWO_SIDED|90.0|0.8693|1.0838||||||Analysis of Geometric mean ration of Cmax for ciprofloxacin on Days 8 and 35||1.0838|0.8693|
73844080|NCT04067011|147235663|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of AUC0-12h.|Ratio of AUC|0.9173|||||TWO_SIDED|90.0|0.8187|1.0278||||||Analysis of Geometric mean ratio of Area under the curve from 0 to 12 hours (AUC0-12h) for doxycycline on Days 8 and 38||1.0278|0.8187|
73844081|NCT04067011|147235663|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of Cmax.|Ratio of Cmax|0.8974|||||TWO_SIDED|90.0|0.7841|1.0271||||||Analysis of Geometric mean ration of Cmax for doxycycline on Days 8 and 38||1.0271|0.7841|
73844082|NCT04067011|147235664|NON_INFERIORITY|Non-inferiority margin is 0.5.|Ratio of GMT (Group 1/Group 3)|1.13|||||TWO_SIDED|95.0|0.78|1.64||||||||1.64|0.78|
73844083|NCT04067011|147235664|NON_INFERIORITY|Non-inferiority margin is 0.5.|Ratio of GMT (Group 2/Group 3)|1.14|||||TWO_SIDED|95.0|0.81|1.6||||||||1.6|0.81|
73844084|NCT05209386|147235687|OTHER||||||||||||||||||Permutation-based clustering analysis was used to identify channels that significantly encode change in acoustic dimensions. For each channel, a sliding-window encoding model was built comparing evoked responses (z-scored voltages) to Canonical Block stimuli across varying F0 with fixed VOT. This analysis identified the n = 17 channels and time windows where neural responses differed according to change in F0.|||
73844085|NCT05209386|147235688|OTHER||||||<|0.0001|||||||t-test, 2 sided|t(20.45) = -5.8||||||<0.0001
73844086|NCT05209386|147235689|OTHER||||||<|0.0001|||||||Mixed Models Analysis|For interaction term (effect of interest): t(1016) = -2.7|||Time-averaged neural responses across respective windows of significance were averaged for all stimuli with ambiguous VOT (Canonical and Reverse blocks) to provide trial-averaged responses. A single linear mixed-effects model was built with fixed effects of F0, condition/listening context (block), and their interaction, as well as a random effect (intercept only) of patient+channel. The effect of interest was the interaction term, indicating that neural responses to F0 varied according to listening context (block).|||<0.0001
73844087|NCT05209386|147235690|OTHER||||||<|0.0001|||||||Mixed Models Analysis|t(48) = -4.50||The null hypothesis is that there is no effect of change in listening context on behavioral responses of participants.||||<0.0001
73898532|NCT02880956|147328896|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.136||0.21|TWO_SIDED|95.0|-0.438|0.097||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.097|-0.438|0.210
73844088|NCT05209386|147235691|OTHER||||||||||||||||||Permutation-based clustering analysis was used to identify channels in non-regions of interest that significantly encode change in acoustic dimensions. For each channel, a sliding-window encoding model was built comparing evoked responses (z-scored voltages) to Canonical Block stimuli across varying F0 with fixed VOT. This analysis identified the n = 4 channels and time windows where neural responses differed according to change in F0.|||
73844089|NCT05209386|147235692|OTHER|||||||0.48|||||||Mixed Models Analysis|For interaction term (effect of interest): t(216) = -0.707|||Time-averaged neural responses across respective windows of significance were averaged for all stimuli with ambiguous VOT (Canonical and Reverse blocks) to provide trial-averaged responses. A single linear mixed-effects model was built with fixed effects of F0, condition/listening context (block), and their interaction, as well as a random effect (intercept only) of patient+channel. The effect of interest was the interaction term, indicating that neural responses to F0 varied according to listening context (block).|||0.480
73844090|NCT00619866|147235730|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.25||0.2311|TWO_SIDED|95.0|-0.81|0.2|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.20|-0.81|0.2311
73844091|NCT00619866|147235730|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.25||0.1521|TWO_SIDED|95.0|-0.86|0.14|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.14|-0.86|0.1521
73844092|NCT00619866|147235731|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2041|TWO_SIDED|95.0|-0.77|0.17|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.17|-0.77|0.2041
73844093|NCT00619866|147235731|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.24||0.3375|TWO_SIDED|95.0|-0.69|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.24|-0.69|0.3375
73844094|NCT00619866|147235731|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.25||0.0354|TWO_SIDED|95.0|-1.01|-0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.04|-1.01|0.0354
73844095|NCT00619866|147235731|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3618|TWO_SIDED|95.0|-0.71|0.26|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.26|-0.71|0.3618
73844096|NCT00619866|147235732|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.46||0.799|TWO_SIDED|95.0|-1.01|0.78|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.78|-1.01|0.7990
73844097|NCT00619866|147235732|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.46||0.5042|TWO_SIDED|95.0|-1.21|0.59|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.59|-1.21|0.5042
73844098|NCT00619866|147235732|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.48||0.1459|TWO_SIDED|95.0|-1.63|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.24|-1.63|0.1459
73844099|NCT00619866|147235732|SUPERIORITY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.48||0.0163|TWO_SIDED|95.0|-2.1|-0.21|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.21|-2.10|0.0163
73844100|NCT00619866|147235732|SUPERIORITY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.5||0.0207|TWO_SIDED|95.0|-2.13|-0.18|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.18|-2.13|0.0207
73844101|NCT00619866|147235732|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.5||0.0038|TWO_SIDED|95.0|-2.42|-0.47|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.47|-2.42|0.0038
73844102|NCT00619866|147235733|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5744|TWO_SIDED|95.0|-0.18|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.10|-0.18|0.5744
73844103|NCT00619866|147235733|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.728|TWO_SIDED|95.0|-0.17|0.12|||Repeated measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.12|-0.17|0.7280
73844104|NCT00619866|147235733|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0195|TWO_SIDED|95.0|-0.32|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.03|-0.32|0.0195
73844105|NCT00619866|147235733|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.5589|TWO_SIDED|95.0|-0.19|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.10|-0.19|0.5589
73844106|NCT00619866|147235733|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5558|TWO_SIDED|95.0|-0.2|0.11|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.11|-0.20|0.5558
73844107|NCT00619866|147235733|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.7121|TWO_SIDED|95.0|-0.18|0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.12|-0.18|0.7121
73844108|NCT00619866|147235734|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.13||0.0286|TWO_SIDED|95.0|-0.54|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.03|-0.54|0.0286
73844109|NCT00619866|147235734|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.121|TWO_SIDED|95.0|-0.45|0.05|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.05|-0.45|0.1210
73844110|NCT00619866|147235734|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.14||0.0024|TWO_SIDED|95.0|-0.68|-0.15|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.15|-0.68|0.0024
73844111|NCT00619866|147235734|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0003|TWO_SIDED|95.0|-0.76|-0.22|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.22|-0.76|0.0003
73844112|NCT00619866|147235734|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0021|TWO_SIDED|95.0|-0.72|-0.16|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.16|-0.72|0.0021
73844113|NCT00619866|147235734|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.14||0.0003|TWO_SIDED|95.0|-0.8|-0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.24|-0.80|0.0003
74084296|NCT01525628|147721698|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|120.74|STANDARD_DEVIATION|19.2||0.2906|TWO_SIDED|90.0|108.47|134.38|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||134.38|108.47|0.2906
73844114|NCT00619866|147235735|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.09||0.0603|TWO_SIDED|95.0|-0.34|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.01|-0.34|0.0603
73844115|NCT00619866|147235735|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.1855|TWO_SIDED|95.0|-0.29|0.06|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.06|-0.29|0.1855
73844116|NCT00619866|147235735|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0012|TWO_SIDED|95.0|-0.48|-0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.12|-0.48|0.0012
73844117|NCT00619866|147235735|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.1002|TWO_SIDED|95.0|-0.33|0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.03|-0.33|0.1002
73844118|NCT00619866|147235735|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0568|TWO_SIDED|95.0|-0.36|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.01|-0.36|0.0568
73844119|NCT00619866|147235735|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.119|TWO_SIDED|95.0|-0.33|0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.04|-0.33|0.1190
73844120|NCT01968980|147235781|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-54.5|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-59.5|-49.5|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference,associated 95 percent (%) confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-49.5|-59.5|<0.001
73844121|NCT01968980|147235782|SUPERIORITY_OR_OTHER||LS mean difference|-37.6|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-41.1|-34.1|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-34.1|-41.1|<0.001
73844122|NCT01968980|147235783|SUPERIORITY_OR_OTHER||LS mean difference|-51.0|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|-55.7|-46.4|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-46.4|-55.7|<0.001
73844123|NCT01968980|147235784|SUPERIORITY_OR_OTHER||LS mean difference|-48.0|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-52.8|-43.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-43.2|-52.8|<0.001
73844124|NCT01968980|147235785|SUPERIORITY_OR_OTHER||LS mean difference|-28.6|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-33.9|-23.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-23.2|-33.9|<0.001
73844125|NCT01968980|147235786|SUPERIORITY_OR_OTHER||LS mean difference|7.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|4.1|9.9|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||9.9|4.1|<0.001
74084297|NCT01525628|147721698|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|93.95|STANDARD_DEVIATION|25.2||0.046|TWO_SIDED|90.0|80.33|109.86|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||109.86|80.33|0.0460
73844126|NCT01968980|147235787|SUPERIORITY_OR_OTHER||LS mean difference|-52.1|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-58.2|-46.0||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-46.0|-58.2|
73898533|NCT02880956|147328896|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73844127|NCT01968980|147235787|SUPERIORITY_OR_OTHER||LS mean difference|-48.0|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|95.0|-53.6|-42.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-42.3|-53.6|
73844128|NCT01968980|147235788|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-40.0|-31.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-31.6|-40.0|
73844129|NCT01968980|147235788|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.8|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-35.8|-27.8||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-27.8|-35.8|
73844130|NCT01968980|147235789|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.5|STANDARD_ERROR_OF_MEAN|2.86|||TWO_SIDED|95.0|-54.1|-42.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-42.8|-54.1|
73844131|NCT01968980|147235789|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.2|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-47.5|-36.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-36.9|-47.5|
73844132|NCT01968980|147235790|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.8|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|95.0|-52.1|-41.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-41.6|-52.1|
73844133|NCT01968980|147235790|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.5|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-45.5|-35.5||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-35.5|-45.5|
73844134|NCT01968980|147235791|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.1|STANDARD_ERROR_OF_MEAN|12.58|||TWO_SIDED|95.0|-59.8|-10.3||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-10.3|-59.8|
73844135|NCT01968980|147235791|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|95.0|-26.3|-4.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-4.4|-26.3|
73844136|NCT01968980|147235792|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|3.1|8.7||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||8.7|3.1|
73844137|NCT01968980|147235792|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|95.0|-0.1|5.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||5.9|-0.1|
73844138|NCT01968980|147235793|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.7|-25.3|
73844139|NCT01968980|147235793|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-7.8|-27.0|
73844140|NCT01968980|147235793|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.04|||TWO_SIDED|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||0.4|-19.4|
73844141|NCT01968980|147235794|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|2.9|7.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||7.8|2.9|
73844142|NCT01968980|147235794|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|2.5|6.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||6.8|2.5|
73844143|NCT01968980|147235794|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|95.0|0.5|5.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||5.4|0.5|
73844144|NCT01968980|147235795|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-2.3|3.6||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.6|-2.3|
74022448|NCT01431287|147597110|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.142||0.7441|TWO_SIDED|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.324|-0.231|0.7441
73844145|NCT01968980|147235795|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-1.9|3.2||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.2|-1.9|
73844146|NCT01968980|147235795|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|-1.9|3.6||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.6|-1.9|
73844147|NCT01968980|147235796|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.7|-25.3|
73844148|NCT01968980|147235796|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-7.8|-27.0|
73844149|NCT01968980|147235796|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.04|||TWO_SIDED|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||0.4|-19.4|
73844150|NCT01968980|147235797|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.8|STANDARD_ERROR_OF_MEAN|3.75|||TWO_SIDED|95.0|-86.2|-71.4||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-71.4|-86.2|
73844151|NCT01968980|147235798|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.2|STANDARD_ERROR_OF_MEAN|4.15|||TWO_SIDED|95.0|-91.3|-75.0||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-75.0|-91.3|
73844152|NCT01968980|147235799|SUPERIORITY_OR_OTHER||LS Mean Difference|-87.0|STANDARD_ERROR_OF_MEAN|4.25|||TWO_SIDED|95.0|-95.4|-78.7||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-78.7|-95.4|
73844153|NCT01968980|147235800|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.8|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-59.2|-48.5||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-48.5|-59.2|
73844154|NCT01968980|147235801|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|95.0|-14.7|-8.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.9|-14.7|
73844155|NCT01968980|147235802|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|2.0|4.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||4.9|2.0|
73844156|NCT01968980|147235803|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-2.2|-1.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.8|-2.2|
73844157|NCT01968980|147235803|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-2.1|-1.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.6|-2.1|
73844158|NCT01968980|147235803|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.8|-1.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.3|-1.8|
73844159|NCT01968980|147235804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.5|-0.4||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.4|-0.5|
74084298|NCT01525628|147721699|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|151.66|STANDARD_DEVIATION|18.5||0.9941|TWO_SIDED|90.0|134.79|170.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||170.64|134.79|0.9941
73844160|NCT01968980|147235804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.4|-0.4||||||Week 24:LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.4|-0.4|
73844161|NCT01968980|147235804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.3|-0.4|
73844162|NCT01968980|147235805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|51.8|||||TWO_SIDED|95.0|25.24|106.1||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||106.10|25.24|
73844163|NCT01968980|147235805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|66.9|||||TWO_SIDED|95.0|30.32|147.43||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||147.43|30.32|
73844164|NCT01968980|147235805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.8|||||TWO_SIDED|95.0|11.85|44.01||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||44.01|11.85|
73844165|NCT01968980|147235806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|200.8|||||TWO_SIDED|95.0|47.16|854.6||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||854.60|47.16|
73844166|NCT01968980|147235806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|228.0|||||TWO_SIDED|95.0|51.95|1000.39||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||1000.39|51.95|
73844167|NCT01968980|147235806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|259.9|||||TWO_SIDED|95.0|34.87|1937.06||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||1937.06|34.87|
73844168|NCT01474109|147235811|SUPERIORITY_OR_OTHER||NB-2 estimate of new DUs per patient|1.103||||0.706|TWO_SIDED|95.0|0.663|1.834|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 3 mg and in Placebo|||1.834|0.663|0.706
73844169|NCT01474109|147235811|SUPERIORITY_OR_OTHER||NB-2 estimate of new DUs per patient|1.268||||0.36|TWO_SIDED|95.0|0.763|2.106|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 10 mg and in Placebo|||2.106|0.763|0.360
73844170|NCT01474109|147235812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.875||||0.667|TWO_SIDED|95.0|0.477|1.606|||Chi-squared|||||1.606|0.477|0.6670
73844171|NCT01474109|147235812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.832||||0.5518|TWO_SIDED|95.0|0.454|1.524|||Chi-squared|||||1.524|0.454|0.5518
73844172|NCT01474109|147235813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.696||||0.3625|TWO_SIDED|95.0|0.319|1.518|||Chi-squared|||||1.518|0.319|0.3625
73844173|NCT01474109|147235813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9362|TWO_SIDED|95.0|0.498|2.133|||Chi-squared|||||2.133|0.498|0.9362
73844174|NCT01474109|147235814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.863|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|||||0.2|-0.1|0.863
73844175|NCT01474109|147235814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.649|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.649
73844176|NCT01474109|147235815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.456|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.456
73844177|NCT01474109|147235815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.44|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.440
73844178|NCT01474109|147235816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.464|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.464
73844179|NCT01474109|147235816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.342|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.342
73844180|NCT02589938|147235817|SUPERIORITY|Repeated measures analysis of covariance (RMANCOVA) models were constructed to assess differences in each outcome adjusting for baseline outcome value, group, time, and group by time interaction assuming an unstructured covariance. The primary objective was assessed using a linear contrast of group effect at 4 weeks||||||0.0167|||||||ANCOVA|||The primary endpoint was to determine whether true acupuncture (TA) was more effective than sham acupuncture (SA) or standard oral hygiene (SOH) at treating xerostomia as assessed by the xerostomia questionnaire (XQ) at Week 4. The study was powered to detect a difference of 10 points with an assumed standard deviation (SD)=16 between each pair of groups on XQ.This assumed a t-test with a two-sided significance level of 0·0133 and 84% power with 20% dropout.||||0.0167
73844181|NCT02521285|147235820|SUPERIORITY|||||||0.343|||||||t-test, 2 sided|||||||0.343
73844182|NCT02521285|147235820|SUPERIORITY|||||||0.149|||||||t-test, 2 sided|||||||0.149
73844183|NCT02521285|147235821|SUPERIORITY|||||||0.878|||||||t-test, 2 sided|||||||0.878
73844184|NCT02521285|147235822|SUPERIORITY|||||||0.382|||||||t-test, 2 sided|||||||0.382
73844185|NCT02521285|147235822|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73844186|NCT02521285|147235823|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
73844187|NCT02521285|147235823|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
73844188|NCT02521285|147235824|SUPERIORITY|||||||0.234|||||||t-test, 2 sided|||||||0.234
73844189|NCT02521285|147235824|SUPERIORITY|||||||0.442|||||||t-test, 2 sided|||||||0.442
73844190|NCT02521285|147235825|SUPERIORITY|||||||0.645|||||||t-test, 2 sided|||||||0.645
73844191|NCT02521285|147235825|SUPERIORITY|||||||0.878|||||||t-test, 2 sided|||||||0.878
73844192|NCT02521285|147235833|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
73844193|NCT02521285|147235834|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||Difference between arms||||0.397
73844194|NCT02521285|147235834|SUPERIORITY|||||||0.983|||||||t-test, 2 sided|||Difference in arms.||||0.983
73844195|NCT02521285|147235835|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
73844196|NCT02521285|147235835|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||||||0.203
73844197|NCT02521285|147235836|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
73844198|NCT02521285|147235836|SUPERIORITY|||||||0.343|||||||t-test, 2 sided|||||||0.343
73844199|NCT02521285|147235837|SUPERIORITY|||||||0.281|||||||t-test, 2 sided|||||||0.281
73844200|NCT02521285|147235837|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
73844201|NCT02521285|147235838|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
74022449|NCT01431287|147597110|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.276|STANDARD_ERROR_OF_MEAN|0.14||0.0492|TWO_SIDED|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.551|0.001|0.0492
74022450|NCT01431287|147597110|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.608|STANDARD_ERROR_OF_MEAN|0.141|<|0.0001|TWO_SIDED|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.884|0.332|<0.0001
74022451|NCT01431287|147597110|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.325|STANDARD_ERROR_OF_MEAN|0.143||0.023|TWO_SIDED|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.605|0.045|0.0230
73844202|NCT02521285|147235838|SUPERIORITY|||||||0.195|||||||t-test, 2 sided|||||||0.195
73844203|NCT02521285|147235839|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
73844204|NCT02521285|147235839|SUPERIORITY|||||||0.432|||||||t-test, 2 sided|||||||0.432
73844205|NCT02521285|147235840|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
73844206|NCT02521285|147235840|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
73844207|NCT02521285|147235841|SUPERIORITY|||||||0.105|||||||t-test, 2 sided|||||||0.105
73844208|NCT02521285|147235841|SUPERIORITY|||||||0.161|||||||t-test, 2 sided|||||||0.161
73844209|NCT02521285|147235844|SUPERIORITY|||||||0.518|||||||t-test, 2 sided|||||||0.518
73844210|NCT02521285|147235845|SUPERIORITY|||||||0.876|||||||t-test, 2 sided|||||||0.876
73844211|NCT02521285|147235845|SUPERIORITY|||||||0.505|||||||t-test, 2 sided|||||||0.505
73844212|NCT02521285|147235846|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
73844213|NCT02521285|147235846|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
73844214|NCT02521285|147235847|SUPERIORITY|||||||0.105|||||||t-test, 2 sided|||||||0.105
73844215|NCT02521285|147235847|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
73844216|NCT03189719|147235860|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.43|0.75|||Stratified Log-Rank|||OS in ESCC PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in ESCC PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.75|0.43|<0.0001
73844217|NCT03189719|147235861|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0006|TWO_SIDED|95.0|0.6|0.88|||Stratified Log-Rank|||OS in ESCC participants of the pembrolizumab + SOC arm was compared to OS in ESCC participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.88|0.60|0.0006
73844218|NCT03189719|147235862|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78|||Stratified Log-Rank|||OS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.78|0.49|<0.0001
73844219|NCT03189719|147235863|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.62|0.86|||Stratified Log-Rank|||OS in all participants of the pembrolizumab + SOC arm was compared to OS in all participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||0.86|0.62|<0.0001
73844220|NCT03189719|147235864|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.54|0.78|||Stratified Log-Rank|||PFS in ESCC participants of the pembrolizumab + SOC arm was compared to PFS in ESCC participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.78|0.54|<0.0001
73844221|NCT03189719|147235865|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.65|||Stratified Log-Rank|||PFS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to PFS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.65|0.41|<0.0001
73898534|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.188||0.303|TWO_SIDED|95.0|-0.564|0.176||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.176|-0.564|0.303
73844222|NCT03189719|147235866|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.55|0.76|||Stratified Log-Rank|||PFS in all participants of the pembrolizumab + SOC arm was compared to PFS in all participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||0.76|0.55|<0.0001
73844223|NCT03189719|147235867|SUPERIORITY||Difference in Percentage|15.8|||<|0.0001|TWO_SIDED|95.0|9.0|22.5|||One-sided p-value|||ORR in all participants of the pembrolizumab + SOC arm was compared to ORR in all participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||22.5|9.0|<0.0001
73844224|NCT03189719|147235868|OTHER||Difference in Percentage|22.8|||<|0.0001|TWO_SIDED|95.0|11.6|33.4|||One-sided p-value|||ORR in ESCC PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to ORR in ESCC PD-L1 CPS ≥10 participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||33.4|11.6|<0.0001
73844225|NCT03189719|147235869|OTHER||Difference in Percentage|12.8||||0.0009|TWO_SIDED|95.0|4.7|20.7|||One-sided p-value|||ORR in ESCC participants of the pembrolizumab + SOC arm was compared to ORR in ESCC participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||20.7|4.7|0.0009
73844226|NCT03189719|147235870|OTHER||Difference in Percentage|24.0|||<|0.0001|TWO_SIDED|95.0|14.3|33.2|||One-sided p-value|||ORR in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to ORR in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||33.2|14.3|<0.0001
73844227|NCT03189719|147235877|OTHER||Difference in LS Means|-0.1||||0.953|TWO_SIDED|95.0|-3.4|3.2|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a constrained longitudinal data analysis (cLDA) model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||3.20|-3.40|0.9530
73844228|NCT03189719|147235878|OTHER||Difference in LS Means|-1.95||||0.5053|TWO_SIDED|95.0|-7.72|3.82|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||3.82|-7.72|0.5053
73844229|NCT03189719|147235879|OTHER||Difference in LS Means|-0.06||||0.9742|TWO_SIDED|95.0|-3.93|3.81|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||3.81|-3.93|0.9742
73844230|NCT03189719|147235880|OTHER||Difference in LS Means|-1.77||||0.481|TWO_SIDED|95.0|-6.71|3.17|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||3.17|-6.71|0.4810
73844231|NCT03189719|147235881|OTHER||Difference in LS Means|-5.54||||0.0436|TWO_SIDED|95.0|-10.93|-0.16|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||-0.16|-10.93|0.0436
73844232|NCT03189719|147235881|OTHER||Difference in LS Means|-2.94||||0.0487|TWO_SIDED|95.0|-5.86|-0.02|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||-0.02|-5.86|0.0487
73844233|NCT03189719|147235881|OTHER||Difference in LS Means|-0.93||||0.5932|TWO_SIDED|95.0|-4.36|2.49|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||2.49|-4.36|0.5932
73844234|NCT03189719|147235882|OTHER||Difference in LS Means|-8.68||||0.0564|TWO_SIDED|95.0|-17.59|0.24|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.24|-17.59|0.0564
74022452|NCT01431287|147597110|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.142||0.7855|TWO_SIDED|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.317|-0.240|0.7855
73844235|NCT03189719|147235882|OTHER||Difference in LS Means|-2.13||||0.3813|TWO_SIDED|95.0|-6.93|2.66|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||2.66|-6.93|0.3813
73844236|NCT03189719|147235882|OTHER||Difference in LS Means|-5.11||||0.0816|TWO_SIDED|95.0|-10.86|0.65|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.65|-10.86|0.0816
73844237|NCT03189719|147235883|OTHER||Difference in LS Means|-4.49||||0.1632|TWO_SIDED|95.0|-10.81|1.83|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||1.83|-10.81|0.1632
73844238|NCT03189719|147235883|OTHER||Difference in LS Means|-1.71||||0.3259|TWO_SIDED|95.0|-5.12|1.71|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||1.71|-5.12|0.3259
73844239|NCT03189719|147235883|OTHER||Difference in LS Means|-1.5||||0.4598|TWO_SIDED|95.0|-5.47|2.48|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||2.48|-5.47|0.4598
73844240|NCT03189719|147235884|OTHER||Difference in LS Means|-8.2||||0.0317|TWO_SIDED|95.0|-15.67|-0.73|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||-0.73|-15.67|0.0317
73844241|NCT03189719|147235884|OTHER||Difference in LS Means|-3.57||||0.0945|TWO_SIDED|95.0|-7.77|0.62|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.62|-7.77|0.0945
73844242|NCT03189719|147235884|OTHER||Difference in LS Means|-4.76||||0.0555|TWO_SIDED|95.0|-9.64|0.11|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.11|-9.64|0.0555
73844243|NCT04569084|147235893|SUPERIORITY|||||||0.777|||||||ANCOVA|||||||0.777
74022453|NCT01431287|147597110|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.142||0.0442|TWO_SIDED|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.564|0.007|0.0442
74022454|NCT00961532|147597147|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||We tested the hypothesis that there would be a change from baseline to 60 minutes after the start of the desmopressin (DDAVP) infusion.||||0.014
73844244|NCT04569084|147235894|SUPERIORITY|||||||0.169|||||||Mixed Model for Repeated Measures (MMRM)|||||||0.169
73844245|NCT04795531|147235899|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin degludec) was strictly below 0.3%.|Treatment difference|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.34|-0.08|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment, region and sulfonylureas (SU)/glinides use as fixed factors, and baseline response as covariate.||-0.08|-0.34|<0.0001
73844246|NCT04043286|147235909|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.18||0.009|TWO_SIDED|95.0|0.1|0.85|||Wilcoxon (Mann-Whitney)|The Shapiro-Wilk test assessed data normality, and paired t-tests or Wilcoxon tests were applied based on normality results.||The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.||0.85|0.10|0.009
73898535|NCT02880956|147328897|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|1.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74022455|NCT02216695|147597182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|1.3|1.4|||Regression, Logistic||This is OR for 65 to 74 years age group with \< 65 years as the reference group|||1.40|1.30|
74022456|NCT02216695|147597182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|1.66|1.79|||Regression, Logistic||This is OR for age group 75 to 84 years age group with \< 65 years as reference|||1.79|1.66|
74022457|NCT02216695|147597182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|1.89|2.19|||Regression, Logistic||This is OR for age group equal to greater than 85 years age group with \< 65 years as reference|||2.19|1.89|
73844247|NCT04043286|147235910|SUPERIORITY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.23||0.049|TWO_SIDED|95.0|-0.0000168|1.25|||Wilcoxon (Mann-Whitney)|||"The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.~Type of Statistical Test"||1.25|-0.0000168|0.049
73844248|NCT04043286|147235911|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.15||0.053|TWO_SIDED|95.0|-0.0000522|0.75|||Wilcoxon (Mann-Whitney)|||"The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.~Type of Statistical Test"||0.75|-0.0000522|0.053
73844249|NCT01323192|147235913|SUPERIORITY_OR_OTHER||Difference in least square means|-4.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.7|-2.4|||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||-2.4|-6.7|<0.0001
73844250|NCT01323192|147235914|SUPERIORITY_OR_OTHER||Difference in least square means|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0002|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||||0.0002
73844251|NCT01323192|147235915|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73844252|NCT01323192|147235916|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
73844253|NCT01323192|147235917|SUPERIORITY_OR_OTHER||Difference in least square means|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0003|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||||0.0003
73844254|NCT01323192|147235918|SUPERIORITY_OR_OTHER|||||||0.4041|||||||ANCOVA|||||||0.4041
73844255|NCT02964377|147235953|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0482|||||||t-test, 2 sided|||||||0.0482
73844256|NCT02964377|147235953|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0075|||||||t-test, 2 sided|||||||0.0075
73844257|NCT02964377|147235953|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0083|||||||t-test, 2 sided|||||||0.0083
73844258|NCT02964377|147235954|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0127|||||||t-test, 2 sided|||||||0.0127
73844259|NCT02964377|147235954|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0202|||||||t-test, 2 sided|||||||0.0202
73844260|NCT02964377|147235954|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0007|||||||t-test, 2 sided|||||||0.0007
74022458|NCT02216695|147597183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.1|1.3|||Regression, Logistic||This is the OR for 1998-2003 discharge period with 2003-08 as the reference group|||1.30|1.10|
73844261|NCT02964377|147235955|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 1)||||<0.0001
73844262|NCT02964377|147235955|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 2)||||<0.0001
73844263|NCT02964377|147235955|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 3)||||<0.0001
73844264|NCT02964377|147235955|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 1)||||<0.0001
73844265|NCT02964377|147235955|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 2)||||<0.0001
73844266|NCT02964377|147235955|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 3)||||<0.0001
73844267|NCT02964377|147235958|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.002|||||||Regression, Linear|||Baseline vs. Week 4||||0.002
73844268|NCT02964377|147235958|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.001
73844269|NCT02964377|147235958|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
73844270|NCT02964377|147235958|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
73844271|NCT02964377|147235958|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
73844272|NCT02964377|147235958|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
73844273|NCT02964377|147235959|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
73844274|NCT02964377|147235959|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
73844275|NCT02964377|147235959|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
73844276|NCT02964377|147235959|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
73844277|NCT02964377|147235959|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
73844278|NCT02964377|147235959|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
73844279|NCT02964377|147235960|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
73844280|NCT02964377|147235960|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
73844281|NCT02964377|147235960|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
73844282|NCT02964377|147235960|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
73844283|NCT02964377|147235960|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
73844284|NCT02964377|147235960|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
73844285|NCT02964377|147235961|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.012|||||||Regression, Linear|||Baseline vs. Week 4||||0.012
73844286|NCT02964377|147235961|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
73844287|NCT02964377|147235961|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
73844288|NCT02964377|147235961|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.01|||||||Regression, Linear|||Baseline vs. Week 8||||0.01
73844289|NCT02964377|147235961|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
73844290|NCT02964377|147235961|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
73844291|NCT02964377|147235963|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.01|||||||Regression, Linear|||Baseline vs. Week 4||||0.01
74022459|NCT02216695|147597183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|1.07|1.18|||Regression, Logistic||This is the OR for 2008-13 discharge period with 2003-08 as the reference group|||1.18|1.07|
74022460|NCT02240134|147597191|SUPERIORITY||Odds Ratio (OR)|1.23||||0.68|TWO_SIDED|95.0|0.46|3.32|||Mixed Models Analysis||Odds ratio for air filter treatment relative to placebo|Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.||3.32|0.46|0.68
73844292|NCT02964377|147235963|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.019|||||||Regression, Linear|||Baseline vs. Week 4||||0.019
73844293|NCT02964377|147235963|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.001
73844294|NCT02964377|147235963|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.05|||||||Regression, Linear|||Baseline vs. Week 8||||0.05
73844295|NCT02964377|147235964|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.054||||||p-value for difference at Week 4|Regression, Linear|||Baseline vs. Week 8||||0.054
74022461|NCT02240134|147597191|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.35|2.72|||Mixed Models Analysis||Odds ratio for filter treatment relative to placebo|Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.||2.72|0.35|0.96
73844296|NCT02964377|147235964|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.009|||||||Regression, Linear|||Baseline vs. Week 4||||0.009
73844297|NCT02964377|147235965|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.025|||||||Regression, Linear|||Baseline vs. Week 8||||0.025
73844298|NCT02964377|147235965|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.026|||||||Regression, Linear|||Baseline vs. Week 4||||0.026
73844299|NCT02964377|147235966|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.006|||||||Regression, Linear|||Baseline vs. Week 4||||0.006
73844300|NCT02964377|147235966|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.002|||||||Regression, Linear|||Baseline vs. Week 8||||0.002
73844301|NCT00710593|147236003|SUPERIORITY_OR_OTHER||% of participants who were responders|97.5||||0.1613|TWO_SIDED|95.0|86.8|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.9|86.8|0.1613
73844302|NCT00710593|147236004|SUPERIORITY_OR_OTHER||% of participants who were responders|96.8||||0.0534|TWO_SIDED|95.0|89.0|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.9|89.0|0.0534
73844303|NCT00710593|147236005|SUPERIORITY_OR_OTHER||% of participants who were responders|96.1||||0.0427|TWO_SIDED|95.0|86.5|99.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.5|86.5|0.0427
73844304|NCT00710593|147236006|SUPERIORITY_OR_OTHER||% of participants who were responders|92.5||||0.0006|TWO_SIDED|95.0|83.4|97.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||97.5|83.4|0.0006
73844305|NCT00710593|147236007|SUPERIORITY_OR_OTHER||% of participants with at least 1 event|49.3||||0.8305|TWO_SIDED|95.0||||The p-value is to test the proportions of subjects with at least one event among Group A during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected|||||||0.8305
73844306|NCT00710593|147236007|SUPERIORITY_OR_OTHER||% of participants with at least 1 event|46.7||||0.8305|TWO_SIDED|||||The p-value is to test the proportions of subjects with at least one event among Group B during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected|||||||0.8305
73844307|NCT00710593|147236015|SUPERIORITY_OR_OTHER||Overall aquisition rate|7.9||||1||95.0|||||Fisher Exact|P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.||||||1.000
73844308|NCT00710593|147236016|SUPERIORITY_OR_OTHER||Overall aquisition rate|1.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
73844309|NCT00710593|147236017|SUPERIORITY_OR_OTHER||Overall aquisition rate|2.0||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
73844310|NCT00710593|147236018|SUPERIORITY_OR_OTHER||Overall aquisition rate|4.5||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
73844311|NCT00710593|147236019|SUPERIORITY_OR_OTHER||Overall aquisition rate|8.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
73844312|NCT00710593|147236020|SUPERIORITY_OR_OTHER||Overall aquistion rate|3.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
73844313|NCT00710593|147236021|SUPERIORITY_OR_OTHER||Overall aquisition rate|6.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
73844314|NCT00710593|147236022|SUPERIORITY_OR_OTHER||Overall aquisition rate|8.1||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
73844315|NCT00710593|147236023|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.0004|TWO_SIDED|95.0|1.02|1.1|||Regression, Logistic|||||1.1|1.02|0.0004
73844316|NCT00710593|147236024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.0012|TWO_SIDED|95.0|1.0|1.1|||Regression, Logistic|||||1.1|1.0|0.0012
73844317|NCT00710593|147236025|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73844318|NCT03186638|147236039|SUPERIORITY|||||||0.7917|||||||ANCOVA|Adjusted for Baseline values||||||0.7917
73844319|NCT01263119|147236040|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.07|||||TWO_SIDED|90.0|1.0|1.13|||Mixed Models Analysis|||||1.13|1.00|
73959875|NCT01924767|147454973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.844||||0.0421||95.0|-25.205|-0.484||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-0.484|-25.205|0.0421
73959876|NCT01924767|147454973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.719||||0.6527|TWO_SIDED|95.0|-14.842|9.403||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||9.403|-14.842|0.6527
73959877|NCT01924767|147454973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.998||||0.1318|TWO_SIDED|95.0|-20.818|2.822||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||2.822|-20.818|0.1318
73844320|NCT01263119|147236041|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.12|||||TWO_SIDED|90.0|1.07|1.16|||Mixed Models Analysis|||||1.16|1.07|
73844321|NCT01263119|147236042|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.9551|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.50|-0.50|0.9551
73844322|NCT01263119|147236043|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.15|||||TWO_SIDED|90.0|1.1|1.2|||Mixed Models Analysis|||||1.20|1.10|
73844323|NCT01263119|147236044|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.13|||||TWO_SIDED|90.0|1.09|1.17|||Mixed Models Analysis|||||1.17|1.09|
73844324|NCT01263119|147236045|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.6094|TWO_SIDED|90.0|-0.5|0.02|||Wilcoxon (Mann-Whitney)|||||0.02|-0.50|0.6094
73844325|NCT01263119|147236046|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.02|1.05|||Mixed Models Analysis|||Least Squares (LS) geometric mean was based on pharmacodynamic AUCINR of warfarin.||1.05|1.02|
73844326|NCT01263119|147236047|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.01|1.08|||Mixed Models Analysis|||Least Squares (LS) geometric mean was based on pharmacodynamic INRmax of warfarin.||1.08|1.01|
73844327|NCT02369536|147236081|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||Intention-to-treat-analysis. Differences between basal values in active and control groups and between T1 vsT0 changes in the two groups assessed by ANOVA and Fisher's exact test.||||<0.05
73844328|NCT02369536|147236084|SUPERIORITY||||||<|0.05|||||||ANOVA|||Intention-to-treat-analysis. Differences between basal values in active and control groups and between T1 vsT0 changes in the two groups assessed by ANOVA and Fisher's exact test.||||<0.05
73959878|NCT01678196|147454976|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED||||||Chi-squared|||||||0.927
73844329|NCT00862940|147236138|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|1.3||0.9754|TWO_SIDED|95.0|-2.6|2.52|||Mixed Models Analysis|||Linear mixed model relating direct change in brain volume (BBSI) to time and its interaction with treatment group. This model additionally includes a time-by-AChEI group interaction as a fixed effect.||2.52|-2.60|0.9754
73844330|NCT00862940|147236139|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.5|STANDARD_ERROR_OF_MEAN|17.52||0.842|TWO_SIDED|95.0|-38.04|31.04|||MMRM|||Mixed model repeated measurements (MMRM) with unstructured covariance including time, time-by-treatment, visit, pre-treatment HCV, and AChEI group.||31.04|-38.04|0.842
73844331|NCT00862940|147236140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|0.79||0.034|TWO_SIDED|95.0|0.13|3.23||The p-value represents the difference from placebo for COWAT at Week 52 (MMRM).|MMRM|||||3.23|0.13|0.034
73844332|NCT00862940|147236141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.46||0.602|TWO_SIDED|95.0|-0.67|1.15||The p-value represents the difference from placebo for MMSE at Week 52 (MMRM).|MMRM|||||1.15|-0.67|0.602
73844333|NCT00432965|147236176|SUPERIORITY||Odds Ratio (OR)|1.89||||0.007|TWO_SIDED|95.0|1.19|3.02|||Fisher Exact|||Time Frame: Days 0-114||3.02|1.19|0.007
73844334|NCT01561469|147236195|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Regression, Logistic|||||||0.009
73844335|NCT01561469|147236196|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Analysis for superinfections category reported.||||1.00
73844336|NCT01561469|147236196|SUPERIORITY_OR_OTHER|||||||0.759|TWO_SIDED||||||Chi-squared|||Analysis for colonization category reported.||||0.759
73844337|NCT01561469|147236197|SUPERIORITY_OR_OTHER|||||||0.773|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.773
73844338|NCT01561469|147236198|SUPERIORITY_OR_OTHER|||||||0.823|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.823
73844339|NCT01561469|147236199|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.276
73844340|NCT01561469|147236200|SUPERIORITY_OR_OTHER|||||||0.512|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.512
73844341|NCT03330847|147236209|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9403|TWO_SIDED|90.0|0.63|1.66|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib monotherapy.|Patient Population BRCAm||1.66|0.63|0.9403
73844342|NCT03330847|147236209|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9282|TWO_SIDED|90.0|0.52|1.88|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib monotherapy.|Patient Population BRCAm||1.88|0.52|0.9282
73844343|NCT03330847|147236209|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.1274|TWO_SIDED|90.0|0.28|1.03|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non BRCAm HRRm||1.03|0.28|0.1274
74022462|NCT02240134|147597192|SUPERIORITY||percent differences in geometric mean PM|-6.96||||0.25|TWO_SIDED|95.0|-30.5|24.55|||Mixed Models Analysis|||Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.||24.55|-30.50|0.250
73844344|NCT03330847|147236209|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.2956|TWO_SIDED|90.0|0.23|1.26|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non BRCAm HRRm||1.26|0.23|0.2956
73844345|NCT03330847|147236209|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2959|TWO_SIDED|90.0|0.5|1.14|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non HRRm||1.14|0.50|0.2959
73844346|NCT03330847|147236209|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0193|TWO_SIDED|90.0|0.28|0.8|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non HRRm||0.80|0.28|0.0193
73844347|NCT03330847|147236210|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.6147|TWO_SIDED|90.0|0.53|1.39|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population BRCAm||1.39|0.53|0.6147
73844348|NCT03330847|147236210|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.7879|TWO_SIDED|90.0|0.48|1.68|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population BRCAm||1.68|0.48|0.7879
73844349|NCT03330847|147236210|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.3695|TWO_SIDED|90.0|0.38|1.31|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non BRCAm HRRm||1.31|0.38|0.3695
73844350|NCT03330847|147236210|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.4586|TWO_SIDED|90.0|0.29|1.58|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non BRCAm HRRm||1.58|0.29|0.4586
73844351|NCT03330847|147236210|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.7452|TWO_SIDED|90.0|0.61|1.31|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non HRRm||1.31|0.61|0.7452
73844352|NCT03330847|147236210|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.1185|TWO_SIDED|90.0|0.37|1.0|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non HRRm||1.00|0.37|0.1185
73844353|NCT01355627|147236220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82|STANDARD_ERROR_OF_MEAN|0.23||0.485|||||||Regression, Logistic|Treatment and pooled centre as covariates.|\< 1 implies a smaller likelihood of a TachoSil treated patient to experience a CSF leak.|||||0.485
73959879|NCT01678196|147454977|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||ANCOVA|ANCOVA reflects change from Time 1 scores (entered as covariate) to Time 2 Scores.||||||0.67
73844354|NCT02293551|147236228|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Squares Mean|1.04||||0.2071|TWO_SIDED|90.0|0.988|1.1|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.10|0.988|0.2071
73844355|NCT02293551|147236228|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Square Means|1.11||||0.0005|TWO_SIDED|90.0|1.06|1.17|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.17|1.06|0.0005
73844356|NCT02293551|147236228|SUPERIORITY_OR_OTHER_LEGACY||Geometric of Ratio Least Square Means|1.08||||0.0123|TWO_SIDED|90.0|1.03|1.13|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.13|1.03|0.0123
73844357|NCT02293551|147236228|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Square Means|1.07||||0.0331|TWO_SIDED|90.0|1.02|1.13|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.13|1.02|0.0331
73844358|NCT02293551|147236228|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.11|||||TWO_SIDED|90.0|1.06|1.16|||||Dose proportionality and the degree of dose proportionality was assessed by fitting the power model versus dose. Estimated ratio of dose-normalized geometric means of PK parameters between the highest and lowest doses assessed dose proportionality.|||1.16|1.06|
73844359|NCT04532749|147236229|SUPERIORITY||Least square (LS) mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.43|=|0.411|TWO_SIDED|95.0|-4.0|1.64|||Mixed Model Repeated Measures (MMRM)|||||1.64|-4.00|=0.411
73844360|NCT04532749|147236230|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.27|=|0.473|TWO_SIDED|95.0|-3.41|1.59|||MMRM model|||In accordance with protocol predefined testing sequence, statistical significance of the primary endpoint was required before testing the first secondary endpoint (MADRS-WOSI) and thus, a formal statistical testing was not performed.||1.59|-3.41|=0.473
73844361|NCT04532749|147236231|SUPERIORITY||LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.45|=|0.167|TWO_SIDED|95.0|-4.87|0.85|||MMRM Model|||In accordance with protocol predefined testing sequence, statistical significance of the primary endpoint was required before testing the second secondary endpoint (PROMIS-SD; Short Form 8a) and thus, a formal statistical testing was not performed.||0.85|-4.87|=0.167
73844362|NCT02769481|147236235|NON_INFERIORITY|A 95% CI was to be calculated to estimate the range of values in which the treatment difference was likely to lie. If the 95% CI fell below the specified non inferiority margin of 0.35%, the non inferiority of bexagliflozin treatment to glimepiride treatment would be demonstrated and the null hypothesis would be rejected.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-0.21|0.11|||||A lower value represents a better treatment effect.|The null hypothesis for the primary endpoint was that the change in HbA1c from baseline to week 60 in the bexagliflozin arm would be greater than change in the glimepiride arm by greater than 0.35%.||0.11|-0.21|
73844363|NCT02769481|147236236|SUPERIORITY||Difference of LS Means|-4.31|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.52||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.||||-3.52|-5.10|< 0.0001
73844364|NCT02769481|147236237|SUPERIORITY||Difference of LS Means|-6.53||||0.0008|TWO_SIDED|95.0|-10.56|-2.51||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.||||-2.51|-10.56|0.0008
73959880|NCT01678196|147454978|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||ANCOVA|ANCOVA results include Time 1 scores as a covariate, thus reflecting change over time||||||0.743
73844365|NCT02769481|147236238|SUPERIORITY||Odds Ratio (OR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.05|0.28||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline HbA1c, background treatment, eGFR at baseline, treatment as a fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over glimepiride.|||0.28|0.05|< 0.0001
73959881|NCT01678196|147454979|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|ANCOVA reflects change for Time 1 values (entered as the covariate) to Time 2 values (entered as the DV)||||||<.001
73959882|NCT03987451|147455008|SUPERIORITY||Odds Ratio (OR)|0.28||||0.0867|TWO_SIDED|95.0|0.06|1.24|||Cochran-Mantel-Haenszel|||The common odds ratio between semaglutide and placebo adjusting for baseline diabetes was estimated along with exact 95% confidence interval based on conditioning on the marginal 2×2 tables.||1.24|0.06|0.0867
73844366|NCT02769481|147236239|SUPERIORITY|Superiority of bexagliflozin over glimepiride in HbA1c reduction from baseline to week 60 will be declared if the upper bound of 95% confidence interval is less than 0|Difference of LS Means|-0.05|||||TWO_SIDED|95.0|-0.21|0.11||||||||0.11|-0.21|
73844367|NCT01230411|147236260|SUPERIORITY||Odds Ratio (OR)|3.12||||0.078|TWO_SIDED|95.0|0.88|11.0|||Regression, Logistic|||||11.0|0.88|0.078
73844368|NCT04756531|147236274|OTHER|Natural log transformed AUClast for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|81.21|||||TWO_SIDED|90.0|69.21|95.28||||||||95.28|69.21|
73959883|NCT00612586|147455083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8956||||||One sided|Log Rank|||||||0.8956
73959884|NCT00612586|147455084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9865||||||One-sided|Log Rank|||||||0.9865
73959885|NCT01194154|147455088|SUPERIORITY_OR_OTHER||treatment effect|2.21||||0.657|TWO_SIDED|95.0|-0.35|4.78|||Wilcoxon (Mann-Whitney)||An analysis of covariance (ANCOVA) model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.|||4.78|-0.35|0.657
73959886|NCT01194154|147455089|SUPERIORITY_OR_OTHER||treatment effect|2.24||||0.709|TWO_SIDED|95.0|-0.54|5.01|||Wilcoxon (Mann-Whitney)||ANCOVA model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.|||5.01|-0.54|0.709
73959887|NCT02314117|147455095|SUPERIORITY||Hazard Ratio (HR)|0.753|||||TWO_SIDED|95.0|0.607|0.935||||||||0.935|0.607|
73959888|NCT02314117|147455096|SUPERIORITY||Hazard Ratio (HR)|0.962|||||TWO_SIDED|95.0|0.801|1.156||||||||1.156|0.801|
73959889|NCT02314117|147455097|SUPERIORITY||Hazard Ratio (HR)|0.926|||||TWO_SIDED|95.0|0.774|1.108||||||||1.108|0.774|
73959890|NCT02314117|147455100|SUPERIORITY||Hazard Ratio (HR)|0.699|||||TWO_SIDED|95.0|0.569|0.859||||||||0.859|0.569|
73959891|NCT02314117|147455101|SUPERIORITY||Hazard Ratio (HR)|0.657|||||TWO_SIDED|95.0|0.499|0.866||||||||0.866|0.499|
73844369|NCT04756531|147236275|OTHER|Natural log transformed AUCinf for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|76.06|||||TWO_SIDED|90.0|60.14|96.2||||||||96.20|60.14|
73844370|NCT04756531|147236276|OTHER|Natural log transformed Cmax for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|56.38|||||TWO_SIDED|90.0|43.42|73.19||||||||73.19|43.42|
73844371|NCT04756531|147236309|OTHER|Natural log transformed AUClast for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|148.91|||||TWO_SIDED|90.0|126.92|174.72||||||||174.72|126.92|
73844372|NCT04756531|147236310|OTHER|Natural log transformed AUCinf for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|146.8|||||TWO_SIDED|90.0|118.8|181.41||||||||181.41|118.80|
73844373|NCT04756531|147236311|OTHER|Natural log transformed Cmax for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|244.84|||||TWO_SIDED|90.0|188.58|317.87||||||||317.87|188.58|
73844374|NCT01400412|147236338|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Two-sided p-value without adjustment for multiple testing, interpreted at the 5% nominal level of significance|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank sum test stratified by age (\<30 and \>=30 years)||The null hypothesis is that there is no difference between the two arms in the percent of total hip BMD change from baseline to week 48||||<0.001
73844375|NCT05395936|147236360|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
73844376|NCT01276704|147236361|SUPERIORITY|||||||0.72||||||a priori threshold for statistical significance: \< 0.05|Wilcoxon (Mann-Whitney)|||83% power to detect an absolute 2.5% reduction in Ki-67 for the treatment group compared with no reduction in the control group.||||0.72
73844377|NCT01276704|147236362|SUPERIORITY|||||||0.018||||||No adjustment for multiple comparisons. Standard threshold of P\<0.05|Wilcoxon (Mann-Whitney)|||||||0.018
73844378|NCT01276704|147236363|SUPERIORITY|||||||0.036||||||No adjustment for multiple comparisons. Standard threshold of P \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.036
73844379|NCT01444911|147236387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||ANOVA|||||||0.89
73959892|NCT02314117|147455102|SUPERIORITY||Hazard Ratio (HR)|1.013|||||TWO_SIDED|95.0|0.77|1.332||||||||1.332|0.770|
73844380|NCT00069641|147236395|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.96|STANDARD_ERROR_OF_MEAN|6.47||0.0049|TWO_SIDED|95.0|5.99|31.93|||ANCOVA|||p-value for treatment difference based on Analysis of covariance (ANCOVA) model containing treatment, region, baseline participant age, and baseline disease score.||31.93|5.99|0.0049
73844381|NCT00402987|147236404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.7||||0.0003||95.0|5.5|17.9|||generalized linear model|p-value was calculated using Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||Null hypothesis: No difference in SPID2 (PI-VAS) at two hours between celecoxib 100 mg and placebo. Sample size was based on an expected effect size of 0.42 (from earlier studies), 80% power and an alpha of 0.05.||17.9|5.5|0.0003
73844382|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.212
73844383|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.056
73844384|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
73844385|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
73844386|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844387|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844388|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844389|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844390|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73959893|NCT02314117|147455104|SUPERIORITY||Hazard Ratio (HR)|1.117|||||TWO_SIDED|95.0|0.79|1.58||||||||1.580|0.790|
74088232|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.12|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.12|<.0001
73844391|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844392|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844393|NCT00402987|147236405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844394|NCT00402987|147236406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
73844395|NCT00402987|147236406|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844396|NCT00402987|147236406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
73844397|NCT00402987|147236406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.007
73959894|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||TWO_SIDED|95.0|0.81|1.31|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-1.||1.31|0.81|
73959895|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||TWO_SIDED|95.0|0.8|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-3||1.16|0.8|
73844398|NCT00402987|147236406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.014
73844399|NCT00402987|147236406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.012
73844400|NCT00402987|147236406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.365
73844401|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.180
73844402|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.069
73959896|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.13|||||TWO_SIDED|95.0|0.92|1.4|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-4||1.4|0.92|
73959897|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||TWO_SIDED|95.0|0.75|1.21|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-5||1.21|0.75|
73844403|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.010
73844404|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
73959898|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.92|||||TWO_SIDED|95.0|0.73|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-6B||1.16|0.73|
73844405|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844406|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844407|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844408|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844409|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844410|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844411|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844412|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844413|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.096
73844414|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.034
73844415|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
73844416|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.010
73844417|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
73844418|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
73959899|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.07|||||TWO_SIDED|95.0|0.89|1.29|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-7F||1.29|0.89|
73844419|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
73844420|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844421|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844422|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844423|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844424|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844425|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.741
73844426|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.759||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.759
73844427|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.775
73844428|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.561
73844429|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.419||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.419
73844430|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.237
73844431|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.146
73844432|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.113
73844433|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086||95.0||||"Analyaia at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.086
73844434|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.111
73844435|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.183
73844436|NCT00402987|147236407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.259
73844437|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844438|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844439|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844440|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73959900|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.79|1.19|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-9V||1.19|0.79|
73844441|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844442|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844443|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844444|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844445|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844446|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844447|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844448|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844449|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.017
73844450|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.011
73844451|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
73844452|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
73844453|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
73844454|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
73844455|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
73844456|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.012
73844457|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.904||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.904
73844458|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.891||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.891
73844459|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.929||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.929
73844460|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.994
74084299|NCT01525628|147721699|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|163.42|STANDARD_DEVIATION|26.0||0.9926|TWO_SIDED|90.0|137.91|193.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||193.64|137.91|0.9926
73844461|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.933
73844462|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.876
73844463|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.622
73844464|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.081||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.081
73844465|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.117
73844466|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.152||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.152
73844467|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.171
73844468|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.197
73844469|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.244
73844470|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.708
73844471|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.106||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.106
73844472|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.140
73844473|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.188||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.188
73844474|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.239||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.239
73844475|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.297
73844476|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.383||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.383
73844477|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.919||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.919
73844478|NCT00402987|147236408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844479|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.537||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.537
73844480|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.697||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.697
73959901|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.81|1.18|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-14||1.18|0.81|
74084300|NCT01525628|147721699|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|98.14|STANDARD_DEVIATION|28.1||0.0392|TWO_SIDED|90.0|81.2|118.63|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||118.63|81.20|0.0392
73844481|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.203||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.203
73844482|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.003
73844483|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844484|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844485|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844486|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844487|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844488|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73959902|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.95|||||TWO_SIDED|95.0|0.77|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-18C||1.16|0.77|
73844489|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844490|NCT00402987|147236409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844491|NCT00402987|147236410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
73844492|NCT00402987|147236410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
73844493|NCT00402987|147236410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.046
73844494|NCT00402987|147236410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.046
73844495|NCT00402987|147236410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.111
73844496|NCT00402987|147236410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.226
73844497|NCT00402987|147236410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.537||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.537
74084301|NCT01525628|147721699|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|122.58|STANDARD_DEVIATION|37.2||0.4374|TWO_SIDED|90.0|99.15|151.55|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||151.55|99.15|0.4374
73844498|NCT00402987|147236411|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.64||||0.01||95.0|1.3|5.5||Treatment as a factor|Regression, Logistic|||||5.5|1.3|0.010
73844499|NCT00402987|147236411|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.07||||0.003||95.0|1.5|6.4||Treatment as a factor|Regression, Logistic|||||6.4|1.5|0.003
73844500|NCT00402987|147236411|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.634||95.0|0.6|2.2||Treatment as a factor|Regression, Logistic|||||2.2|0.6|0.634
73844501|NCT00402987|147236412|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.63||||0.202||95.0|0.8|3.5||Treatment as a factor|Regression, Logistic|||||3.5|0.8|0.202
73844502|NCT00402987|147236412|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.077||95.0|0.9|5.1||Treatment as a factor|Regression, Logistic|||||5.1|0.9|0.077
73844503|NCT00402987|147236412|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.95||||0.134||95.0|0.8|4.7||Treatment as a factor|Regression, Logistic|||||4.7|0.8|0.134
73844504|NCT00402987|147236412|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.84||||0.671||95.0|0.4|1.9||Treatment as a factor|Regression, Logistic|||||1.9|0.4|0.671
73844505|NCT00402987|147236412|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||0.484||95.0|0.3|1.7||Treatment as a factor|Regression, Logistic|||||1.7|0.3|0.484
73844506|NCT00402987|147236412|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||Treatment as a factor|Regression, Logistic|||||2.8|0.4|0.814
73844507|NCT00402987|147236413|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
73844508|NCT00402987|147236413|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
73844509|NCT00402987|147236413|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
73844510|NCT00402987|147236414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours.||||<0.05
73844511|NCT00402987|147236414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours||||<0.05
73844512|NCT00402987|147236415|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours||||<0.05
73844513|NCT00402987|147236415|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours||||<0.05
73844514|NCT00402987|147236416|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
73844515|NCT00402987|147236416|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall test of Celecoxib 100mg (pooled) versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
73844516|NCT00402987|147236416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.889||95.0||||Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg (pooled) that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.889
73844517|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
73844518|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.002
73844519|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||Analysis at 12 hours Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.015
73844520|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.411
73844521|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.930
73844522|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.438||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.438
73844523|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.002
73844524|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.013
73844525|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.015
73844526|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.748||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.748
74088233|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.16||0.0001|TWO_SIDED|95.0|-0.95|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.95|0.0001
73844527|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.958
73844528|NCT00402987|147236417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.747||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.747
73844529|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.999
73844530|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.609
73844531|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.076
73844532|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
73844533|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844534|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844535|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844536|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844537|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844538|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
74022463|NCT02240134|147597192|SUPERIORITY||percent differences in geometric mean PM|11.77||||0.295|TWO_SIDED|95.0|-16.57|49.72||Statistical significance selected as 95% confidence interval of the estimation parameter that excludes the null value, 0.|Mixed Models Analysis||Difference in indoor PM2.5 for education treatment versus placebo.|Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.||49.72|-16.57|0.295
73844539|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844540|NCT00402987|147236418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
73844541|NCT00402987|147236419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.003
73844542|NCT00402987|147236419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
73844543|NCT00402987|147236419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.043
73844544|NCT00402987|147236419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.032
73844545|NCT00402987|147236419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.029
73844546|NCT00402987|147236419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.066||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.066
73844547|NCT00402987|147236419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.482||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.482
73844548|NCT00402987|147236420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|||<|0.001||95.0|0.8|1.9||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.9|0.8|<0.001
73844549|NCT00402987|147236420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.002||95.0|0.4|1.5||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|0.4|0.002
73844550|NCT00402987|147236420|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.186||95.0|-1.0|0.2||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||0.2|-1.0|0.186
73844551|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.961
73844552|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.985||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.985
73844553|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.975||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.975
73844554|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.532
74022464|NCT00206726|147597193|SUPERIORITY_OR_OTHER||CR rate|0.0833||||0.014||90.0|0.0334|0.1673||2-sided p-value computed from an exact binomial test comparing the observed rate versus 2% historical rate|exact binomial test|||Comparison of CR rate versus 2 percent (%) historic control (p-value and 90% confidence interval)||0.1673|0.0334|0.014
73844555|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.690
73844556|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.820
73844557|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.180
73844558|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.344
73844559|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.693
73844560|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.039
73844561|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.154
73844562|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.521||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.521
73844563|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
73844564|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.070
73844565|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.344
73844566|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
73844567|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
73844568|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.249||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.249
73844569|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73959903|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.15|||||TWO_SIDED|95.0|0.95|1.4|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19A||1.4|0.95|
73959904|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||TWO_SIDED|95.0|0.84|1.25|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19F||1.25|0.84|
74022465|NCT00450580|147597216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms is greater than -12%.|Risk Difference (RD)|-0.9||||||95.0|-11.4|9.5||||||||9.5|-11.4|
73844570|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
73844571|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.205
73844572|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844573|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
73844574|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.186||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.186
73844575|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844576|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844577|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.179||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.179
73844578|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844579|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844580|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.259
73844581|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844582|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844583|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.393||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.393
73844584|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844585|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844586|NCT00402987|147236421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.512
73844587|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844588|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844589|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.026
73844590|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.463
74022466|NCT03804671|147597224|OTHER|Absolute bioavailability. The statistical model was an ANOVA on the logarithmic scale including the fixed effect for 'formulation' and 'subject' as a random effect.|Ratio of the geometric means (T/R) %|70.32|||||TWO_SIDED|90.0|56.69|87.23|||||The geometric coefficient of variation (gCV) = 18.7. Ratio was calculated as (AUC0-∞/dose) oral /(AUC0-∞/dose) intravenous multiplied by 100.|||87.23|56.69|
74084302|NCT01525628|147721699|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|130.44|STANDARD_DEVIATION|35.3||0.647|TWO_SIDED|90.0|107.57|158.18|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||158.18|107.57|0.6470
73844591|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.131
73844592|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.053
73844593|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844594|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844595|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.020
73844596|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.484
73844597|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.197
73844598|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.086
73844599|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844600|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844601|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
73844602|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.561
73844603|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.252||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.252
73844604|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.136
73844605|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844606|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844607|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
73844608|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.653||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.653
73844609|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.287||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.287
73844610|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.191||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.191
74084303|NCT01525628|147721699|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|87.77|STANDARD_DEVIATION|36.9||0.2372|TWO_SIDED|90.0|70.32|109.54|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||109.54|70.32|0.2372
73844611|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844612|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844613|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
73844614|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.741
73844615|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.326
73844616|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.256||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.256
73844617|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844618|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
73844619|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.016
73844620|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.808||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.808
73844621|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.394||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.394
73844622|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.343
73844623|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
73844624|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.029
73844625|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.023
73844626|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.892||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.892
73844627|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.952||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.952
73844628|NCT00402987|147236422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.948
73844629|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.775
73844630|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.094||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.094
74084304|NCT01525628|147721700|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|117.67|STANDARD_DEVIATION|15.6||0.1519|TWO_SIDED|90.0|106.49|130.0|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||130.00|106.49|0.1519
73844631|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.114||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.114
73844632|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
73844633|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844634|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844635|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844636|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844637|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844638|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844639|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844640|NCT00402987|147236423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
73844641|NCT00402987|147236424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
73844642|NCT00402987|147236424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
73844643|NCT00402987|147236424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.007
73844644|NCT00402987|147236424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.015
73844645|NCT00402987|147236424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.033
73844646|NCT00402987|147236424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.036
73844647|NCT00402987|147236424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.500
73844648|NCT00402987|147236425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.2|||<|0.001||95.0|8.5|23.8||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||23.8|8.5|<0.001
73844649|NCT00402987|147236425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.2||||0.009||95.0|2.6|17.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||17.9|2.6|0.009
73844650|NCT00402987|147236425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9||||0.127||95.0|-13.5|1.7||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.7|-13.5|0.127
73844651|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.480
73844652|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.780
73844653|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.667||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.667
73844654|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.153
73844655|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.479||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.479
73844656|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.469||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.469
74029774|NCT03151148|147614041|SUPERIORITY||Geometric mean ratio (GMR)|0.147||||0.133|TWO_SIDED|95.0|0.0121|1.8018|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.8018|0.0121|0.133
73844657|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.062
73844658|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.284
73844659|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.421||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.421
73844660|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
73844661|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.171
73844662|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.354||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.354
73844663|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
73844664|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.090
73844665|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.262
73844666|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
74084305|NCT01525628|147721700|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|117.01|STANDARD_DEVIATION|30.9||0.2827|TWO_SIDED|90.0|96.06|142.52|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day17 vs. Day 1||142.52|96.06|0.2827
73844667|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.044
73844668|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.194||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.194
73844669|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844670|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.020
73844671|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.148
73844672|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844673|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
73844674|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.127||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.127
73844675|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844676|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
73844677|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.122
73844678|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844679|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844680|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.164||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.164
73844681|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844682|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73959905|NCT02045836|147455134|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.89|||||TWO_SIDED|95.0|0.7|1.12|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-23F||1.12|0.7|
73844683|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.244
73844684|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73959906|NCT02045836|147455135|NON_INFERIORITY|Non Inferiority criterion used: UL of the 95% CI for the anti-gE antibodies GMC ratio between the Control group and the Co-Ad group had to be below 1.5|Adjusted GMC|1.02|||||TWO_SIDED|95.0|0.93|1.11|||ANCOVA|Ancova model: adjustment for baseline concentration and age - pooled variance|Adjusted ratios of GMCs between groups (Control group and Co-Ad group)|Adjusted ratios of GMCs between groups (Control group and Co-Ad group) for anti-gE antibody ELISA concentrations||1.11|0.93|
73844685|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844686|NCT00402987|147236426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.336||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.336
73844687|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844688|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844689|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.090
73844690|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.518||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.518
73844691|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.038
73844692|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.019
73844693|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844694|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844695|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.081||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.081
73844696|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.552
73844697|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.050
74084306|NCT01525628|147721700|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|92.11|STANDARD_DEVIATION|32.6||0.1326|TWO_SIDED|90.0|74.38|114.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||114.07|74.38|0.1326
73844698|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.027
73844699|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844700|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844701|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.071
73844702|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.609
73844703|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.065||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.065
73844704|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.042
73844705|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844706|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844707|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.070
73844708|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.689||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.689
73844709|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.075||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.075
73844710|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.059
73844711|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844712|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844713|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.069
73844714|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.762||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.762
73844715|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.089
73844716|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.083
73844717|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844718|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
73844719|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.064
73844720|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.841||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.841
73844721|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.110
73844722|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.119
73844723|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
73844724|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.015
73844725|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.087||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.087
73844726|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.826||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.826
73844727|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.345||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.345
73844728|NCT00402987|147236427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.530
73844729|NCT00402987|147236428|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.73||||0.149||95.0|0.8|3.7|||Regression, Logistic|Treatment as a factor||||3.7|0.8|0.149
73844730|NCT00402987|147236428|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.95||||0.076||95.0|0.9|4.1|||Regression, Logistic|Treatment as a factor||||4.1|0.9|0.076
73844731|NCT00402987|147236428|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.733||95.0|0.6|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.6|0.733
73844732|NCT00402987|147236429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.03||95.0|1.1|5.0|||Regression, Logistic|Treatment as a factor||||5.0|1.1|0.030
73844733|NCT00402987|147236429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.064||95.0|1.0|5.7|||Regression, Logistic|Treatment as a factor||||5.7|1.0|0.064
73844734|NCT00402987|147236429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83||||0.201||95.0|0.7|4.6|||Regression, Logistic|Treatment as a factor||||4.6|0.7|0.201
73844735|NCT00402987|147236429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.575||95.0|0.5|3.0|||Regression, Logistic|Treatment as a factor||||3.0|0.5|0.575
73844736|NCT00402987|147236429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1||95.0|0.4|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.4|1.000
73844737|NCT00402987|147236429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3|||Regression, Logistic|Treatment as a factor||||3.3|0.5|0.624
73844738|NCT00402987|147236430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.28|||<|0.001||95.0|0.7|1.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.9|0.7|<0.001
73844739|NCT00402987|147236430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88||||0.003||95.0|0.3|1.5||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|0.3|0.003
73844740|NCT00402987|147236430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.177||95.0|-1.0|0.2||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||0.2|-1.0|0.177
73844741|NCT00402987|147236430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.25|||<|0.001||95.0|3.0|7.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||7.5|3.0|<0.001
73844742|NCT00402987|147236430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.54|||<|0.001||95.0|2.3|6.8||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||6.8|2.3|<0.001
74084307|NCT01525628|147721700|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|95.55|STANDARD_DEVIATION|29.2||0.0432|TWO_SIDED|90.0|80.63|113.24|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||113.24|80.63|0.0432
73844743|NCT00402987|147236430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.531||95.0|-3.0|1.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|-3.0|0.531
73844744|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.07|||<|0.001||95.0|4.4|13.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||13.7|4.4|<0.001
73844745|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.46|||<|0.001||95.0|4.7|16.2||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||16.2|4.7|<0.001
73844746|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96||||0.041||95.0|0.2|11.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.7|0.2|0.041
73844747|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39||||0.633||95.0|-7.1|4.3||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||4.3|-7.1|0.633
73844748|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.11||||0.284||95.0|-2.6|8.8||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||8.8|-2.6|0.284
73844749|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5||||0.18||95.0|-2.1|11.1||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.1|-2.1|0.180
73844750|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.57||||0.009||95.0|3.4|23.7||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||23.7|3.4|0.009
73844751|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.15||||0.026||95.0|1.7|26.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||26.6|1.7|0.026
73844752|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.39||||0.138||95.0|-3.0|21.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||21.8|-3.0|0.138
73844753|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.926||95.0|-13.0|11.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.8|-13.0|0.926
73844754|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.18||||0.507||95.0|-8.2|16.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||16.6|-8.2|0.507
73844755|NCT00402987|147236431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.77||||0.513||95.0|-9.6|19.1||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||19.1|-9.6|0.513
73844756|NCT00402987|147236432|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.93||||0.023||95.0|1.2|7.4|||Regression, Logistic|Treatment as a factor||||7.4|1.2|0.023
73844757|NCT00402987|147236432|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.13||||0.015||95.0|1.2|7.9|||Regression, Logistic|Treatment as a factor||||7.9|1.2|0.015
73844758|NCT00402987|147236432|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.854||95.0|0.5|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.5|0.854
73844759|NCT00402987|147236433|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.46||||0.013||95.0|1.3|9.2|||Regression, Logistic|Treatment as a factor||||9.2|1.3|0.013
73844760|NCT00402987|147236433|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.03||||0.003||95.0|1.7|14.5|||Regression, Logistic|Treatment as a factor||||14.5|1.7|0.003
73844761|NCT00402987|147236433|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.99||||0.057||95.0|1.0|9.2|||Regression, Logistic|Treatment as a factor||||9.2|1.0|0.057
73844762|NCT00402987|147236433|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.758||95.0|0.5|2.9|||Regression, Logistic|Treatment as a factor||||2.9|0.5|0.758
73844763|NCT00402987|147236433|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.69||||0.381||95.0|0.3|1.6|||Regression, Logistic|Treatment as a factor||||1.6|0.3|0.381
73844764|NCT00402987|147236433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.68||||0.313||95.0|0.6|4.6|||Regression, Logistic|Treatment as a factor||||4.6|0.6|0.313
73844765|NCT00402987|147236434|SUPERIORITY_OR_OTHER_LEGACY||NNT at 6 hours|8.2||||||95.0|4.5|46.4||||||NNT is the inverse of the absolute risk reduction at 6 hours||46.4|4.5|
73844766|NCT00402987|147236434|SUPERIORITY_OR_OTHER_LEGACY||NNT at 6 hours|7.5||||||95.0|4.3|32.0||||||NNT is the inverse of the absolute risk reduction at 6 hours||32.0|4.3|
73844767|NCT00402987|147236435|SUPERIORITY_OR_OTHER_LEGACY||NNT at 12 hours|7.5||||||95.0|4.3|28.7||||||NNT is the inverse of the absolute risk reduction at 12 hours||28.7|4.3|
73844768|NCT00402987|147236435|SUPERIORITY_OR_OTHER_LEGACY||NNT at 12 hours|5.0||||||95.0|3.0|16.7||||||NNT is the inverse of the absolute risk reduction at 12 hours||16.7|3.0|
73844769|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.77|||<|0.001||95.0|1.9|7.6||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||7.6|1.9|<0.001
74088234|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.99|<.0001
73844770|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.72||||0.005||95.0|1.3|5.5||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.5|1.3|0.005
73844771|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.72||||0.286||95.0|0.4|1.3||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||1.3|0.4|0.286
73844772|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.37||||0.001||95.0|1.6|7.1||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||7.1|1.6|0.001
73844773|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.05||||0.004||95.0|1.4|6.5||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||6.5|1.4|0.004
73844774|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9||||0.752||95.0|0.5|1.7||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||1.7|0.5|0.752
73844775|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.57|||<|0.001||95.0|1.9|10.7||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||10.7|1.9|<0.001
73844776|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.68||||0.003||95.0|1.6|8.7||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||8.7|1.6|0.003
73844777|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81||||0.511||95.0|0.4|1.5||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||1.5|0.4|0.511
73844778|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.05||||0.009||95.0|1.3|7.0||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||7.0|1.3|0.009
73844779|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.7|1.2|0.014
73844780|NCT00402987|147236436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.94||||0.863||95.0|0.5|1.9||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||1.9|0.5|0.863
73844781|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.92||||0.004||95.0|1.4|6.1||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||6.1|1.4|0.004
73844782|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37||||0.052||95.0|1.0|5.7||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.7|1.0|0.052
73844783|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.13||||0.095||95.0|0.9|5.1||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.1|0.9|0.095
73844784|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.431||95.0|0.6|3.0||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||3.0|0.6|0.431
73844785|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.602||95.0|0.6|2.7||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||2.7|0.6|0.602
73844786|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||2.8|0.4|0.814
73844787|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.7|1.2|0.014
73844788|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.23||||0.016||95.0|1.2|8.4||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||8.4|1.2|0.016
73844789|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.54||||0.063||95.0|0.9|6.8||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.8|0.9|0.063
73844790|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.775||95.0|0.5|2.7||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||2.7|0.5|0.775
73844791|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.779||95.0|0.4|2.0||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||2.0|0.4|0.779
73844792|NCT00402987|147236437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||3.3|0.5|0.624
73844793|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.001
73844794|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.012
73844795|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.453||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.453
73844796|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||<0.001
73844797|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
73844798|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.814||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||0.814
73844799|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.024
73844800|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.022
73844801|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.966||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.966
73844802|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
74029775|NCT03151148|147614041|SUPERIORITY||Geometric mean ratio (GMR)|0.371||||0.437|TWO_SIDED|95.0|0.0304|4.5392|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.5392|0.0304|0.437
73844803|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
73844804|NCT00402987|147236438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.798||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.798
73844805|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||<0.001
73844806|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||<0.001
73844807|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.008
73844808|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.709||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.709
73844809|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.331||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.331
73844810|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.246||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.246
73844811|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.001
73844812|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||<0.001
73844813|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.219
73844814|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.095||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.095
73844815|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.463
73844816|NCT00402987|147236439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.038
73844817|NCT00402987|147236440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||0.001
73844818|NCT00402987|147236440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0|||||Regression, Logistic|Treatment as a factor||||||0.008
73844819|NCT00402987|147236440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557||95.0|||||Regression, Logistic|Treatment as a factor||||||0.557
73844820|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||<0.001
73844821|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.002
73844822|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.036
73844823|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.339
73844824|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||1.000
73844825|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.401||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.401
73844826|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.003
73844827|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.002
73844828|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.223
73844829|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.198
73844830|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.604||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.604
73844831|NCT00402987|147236441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.117
73844832|NCT00402987|147236444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||0.001
73844833|NCT00402987|147236444|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||<0.001
73844834|NCT00402987|147236444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||Regression, Logistic|Treatment as a factor||||||0.025
73844835|NCT00402987|147236444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||95.0|||||Regression, Logistic|Treatment as a factor||||||0.539
74084308|NCT01525628|147721700|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|75.19|STANDARD_DEVIATION|30.3||0.7367|TWO_SIDED|90.0|63.64|88.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||88.82|63.64|0.7367
73844836|NCT00402987|147236444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0|||||Regression, Logistic|Treatment as a factor||||||0.329
73844837|NCT00402987|147236444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0|||||Regression, Logistic|Treatment as a factor||||||0.171
73844838|NCT00402987|147236445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Regression, Logistic|Treatment as a factor||||||0.007
73844839|NCT00402987|147236445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0|||||Regression, Logistic|Treatment as a factor||||||0.244
73844840|NCT00402987|147236445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0|||||Regression, Logistic|Treatment as a factor||||||0.096
73844841|NCT00402987|147236445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.579||95.0|||||Regression, Logistic|Treatment as a factor||||||0.579
73844842|NCT00402987|147236445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||95.0|||||Regression, Logistic|Treatment as a factor||||||0.277
73844843|NCT00402987|147236445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.649||95.0|||||Regression, Logistic|Treatment as a factor||||||0.649
73844844|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4|||<|0.001||95.0|7.5|23.2||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||23.2|7.5|<0.001
73844845|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.4||||0.003||95.0|4.9|24.0||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||24.0|4.9|0.003
73844846|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.2||||0.096||95.0|-1.5|17.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||17.8|-1.5|0.096
73844847|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.2||||0.141||95.0|-2.4|16.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||16.8|-2.4|0.141
73844848|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.849||95.0|-8.6|10.5||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||10.5|-8.6|0.849
73844849|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.3||||0.266||95.0|-4.8|17.4||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||17.4|-4.8|0.266
73844850|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.141||95.0|-5.4|0.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||0.8|-5.4|0.141
73844851|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.312||95.0|-5.7|1.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||1.8|-5.7|0.312
73844852|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.724||95.0|-4.5|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.1|-4.5|0.724
73844853|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.398||95.0|-5.4|2.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||2.1|-5.4|0.398
73844854|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.846||95.0|-4.1|3.4||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.4|-4.1|0.846
73844855|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.572||95.0|-5.6|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.1|-5.6|0.572
73844856|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.014||95.0|1.2|10.4||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||10.4|1.2|0.014
73844857|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.573||95.0|-4.0|7.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||7.2|-4.0|0.573
73844858|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.482||95.0|-7.7|3.6||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||3.6|-7.7|0.482
73844859|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.007||95.0|2.2|13.5||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||13.5|2.2|0.007
73844860|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.2||||0.143||95.0|-1.4|9.8||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||9.8|-1.4|0.143
73844861|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.6||||0.273||95.0|-2.9|10.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||10.2|-2.9|0.273
74084309|NCT01525628|147721700|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.14|STANDARD_DEVIATION|34.3||0.8547|TWO_SIDED|90.0|56.84|86.56|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||86.56|56.84|0.8547
73844862|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0||||0.003||95.0|4.4|21.6||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||21.6|4.4|0.003
73844863|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.7||||0.029||95.0|1.2|22.2||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||22.2|1.2|0.029
73844864|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.2||||0.251||95.0|-4.4|16.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||16.8|-4.4|0.251
73844865|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8||||0.204||95.0|-3.7|17.4||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||17.4|-3.7|0.204
73844866|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.808||95.0|-9.2|11.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||11.8|-9.2|0.808
73844867|NCT00402987|147236446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.5||||0.371||95.0|-6.6|17.7||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||17.7|-6.6|0.371
73844868|NCT00402987|147236447|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||<0.001
73844869|NCT00402987|147236447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.002
73844870|NCT00402987|147236447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.235||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.235
73844871|NCT00402987|147236447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.012
73844872|NCT00402987|147236447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.438||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.438
73959907|NCT02459899|147455202|SUPERIORITY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.139||0.07|TWO_SIDED|95.0|-0.53|0.02||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||0.02|-0.53|0.07
73959908|NCT02459899|147455202|SUPERIORITY||Least squares mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.135|<|0.001|TWO_SIDED|95.0|-0.75|-0.22||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.22|-0.75|<0.001
73844873|NCT00402987|147236447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.067||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.067
73844874|NCT00402987|147236448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.128
73959909|NCT02459899|147455202|SUPERIORITY||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.136||0.006|TWO_SIDED|95.0|-0.65|-0.11||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.11|-0.65|0.006
73844875|NCT00402987|147236448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.123||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.123
73844876|NCT00402987|147236448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.266||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.266
73844877|NCT00402987|147236448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.849||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.849
73844878|NCT00402987|147236448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.828||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.828
73844879|NCT00402987|147236448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.741
73844880|NCT01668004|147236449|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|||Treatment comparison of uveitis occurrence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=93.||||1.0000
73844881|NCT01668004|147236450|SUPERIORITY_OR_OTHER||Treatment Ratio|4.5|||<|0.0001|TWO_SIDED|95.0|3.86|5.25|||Generalized estimating equation|||Treatment difference (expressed as ratio) in uveitis incidence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=92.||5.25|3.86|<0.0001
73844882|NCT02448381|147236458|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||||||0.04
73844883|NCT02448381|147236459|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
73844884|NCT02448381|147236460|SUPERIORITY|||||||0.046|||||||McNemar|||||||0.046
73844885|NCT02448381|147236461|SUPERIORITY||||||=|0.0009|||||||Fisher Exact|||||||=0.0009
73844886|NCT02448381|147236462|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73844887|NCT01170663|147236464|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.807||||0.0169|TWO_SIDED|95.0|0.678|0.962|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.962|0.678|0.0169
73844888|NCT01170663|147236465|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.635|||<|0.0001|TWO_SIDED|95.0|0.536|0.752|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.752|0.536|<0.0001
73844889|NCT01170663|147236466|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.596|||<|0.0001|TWO_SIDED|95.0|0.494|0.72|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.720|0.494|<0.0001
73844890|NCT01170663|147236468|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.14||||0.0001|TWO_SIDED|95.0|1.45|3.16|||Cochran-Mantel-Haenszel|Adjusted for stratification factors: geographic region, time-to-progression from the start of first-line therapy and disease measurability.||||3.16|1.45|0.0001
73844891|NCT01170663|147236476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3973||||||Analysis of covariance (ANCOVA) included treatment group, randomization stratification factors and baseline value of Global Health Status scale.|ANCOVA|||||||0.3973
73844892|NCT03510273|147236555|OTHER|"Type of statistical test: Independence~Description: Adequacy of baseline image"||||||0.396|||||||Fisher Exact|||||||0.396
73844893|NCT03510273|147236555|OTHER|"Type of statistical test: Independence~Description: Squamous columnar junction visibility"||||||0.351|||||||Fisher Exact|||||||0.351
73844894|NCT03510273|147236555|OTHER|"Type of statistical test: Independence~Description: Visible abnormal areas"||||||0.774|||||||Fisher Exact|||||||0.774
73844895|NCT03510273|147236555|OTHER|"Type of statistical test: Independence~Description: Location of the lesion"||||||1|||||||Fisher Exact|||||||1
73844896|NCT03510273|147236555|OTHER|"Type of statistical test: Independence~Description: Mosaic of the worst lesion"||||||0.36|||||||Fisher Exact|||||||0.36
73844897|NCT03510273|147236555|OTHER|"Type of Statistical Test: Independence~Description: Acetowhite changes"||||||0.881|||||||Fisher Exact|||||||0.881
73844898|NCT03510273|147236555|OTHER|"Type of Statistical Test: Independence~Description: Border of the worst lesion"||||||0.829|||||||Fisher Exact|||||||0.829
73844899|NCT03510273|147236555|OTHER|"Type of Statistical Test: Independence~Description: Possible diagnosis"||||||1|||||||Fisher Exact|||||||1
74084310|NCT01525628|147721701|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|102.7|STANDARD_DEVIATION|45.9||0.1159|TWO_SIDED|90.0|77.89|135.39|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||135.39|77.89|0.1159
73844900|NCT03510273|147236555|OTHER|"Type of Statistical Test: Independence~Description: Baseline histology"||||||1|||||||Fisher Exact|||||||1
73844901|NCT03510273|147236555|OTHER|"Type of Statistical Test: Independence~Description: Size of the worst lesion (% coverage)"||||||0.493|||||||Fisher Exact|||||||0.493
73844902|NCT01276106|147236558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.175||0.044|TWO_SIDED|95.0|-0.7|-0.01||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||-0.01|-0.70|0.044
73844903|NCT01276106|147236558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.176||0.0979|TWO_SIDED|95.0|-0.64|0.05||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||0.05|-0.64|0.0979
73844904|NCT01276106|147236558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.174||0.2643|TWO_SIDED|95.0|-0.54|0.15||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||0.15|-0.54|0.2643
73844905|NCT00253422|147236615|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.76|TWO_SIDED|95.0|0.86|1.24|||Log Rank|||||1.24|0.86|0.76
73844906|NCT00253422|147236615|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.83|1.2|||Log Rank|||||1.20|0.83|1.00
73844907|NCT00253422|147236616|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||0.99
73844908|NCT00253422|147236616|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||0.12
73844909|NCT00253422|147236618|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
73844910|NCT00253422|147236618|SUPERIORITY|||||||0.94|||||||Chi-squared|||||||0.94
73844911|NCT00253422|147236620|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.84|1.21|||Log Rank||HR less than 1 favour Faslodex + Arimidex|||1.21|0.84|0.95
73844912|NCT00253422|147236620|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.66|TWO_SIDED|95.0|0.87|1.25|||Log Rank||HR less than 1 favours Faslodex + placebo|||1.25|0.87|0.66
73844913|NCT00253422|147236621|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.91|TWO_SIDED|95.0|0.82|1.19|||Log Rank||HR less than 1 favours Faslodex + Arimidex|||1.19|0.82|0.91
73844914|NCT00253422|147236621|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.31|TWO_SIDED|95.0|0.91|1.32|||Log Rank||HR less than 1 favours Faslodex + Placebo|||1.32|0.91|0.31
73844916|NCT02581930|147236635|OTHER|Exact binomial test|Probability of response|0.0||||1|ONE_SIDED|||||Significant if p-value is less than 0.1|Exact binomial test, 1-sided||Estimated as proportion of subjects with response|The primary comparison was between the response rate of an ineffective drug, such as investigators' choice chemotherapy (5%), and the response rate of ibrutinib.||||1.00
73844917|NCT00285779|147236647|SUPERIORITY_OR_OTHER|||||||0.0978|TWO_SIDED||||||Fisher Exact|||||||0.0978
73844918|NCT00285779|147236648|OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
73844919|NCT00285779|147236649|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.031
73844920|NCT00285779|147236649|OTHER|||||||0.34|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.34
73844921|NCT00285779|147236649|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
73844922|NCT00285779|147236649|OTHER|||||||0.22|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.22
73844923|NCT00285779|147236650|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline||||>0.9999
73844924|NCT00285779|147236650|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline||||>0.9999
73844925|NCT00285779|147236651|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
73844926|NCT00285779|147236651|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline||||>0.9999
73844927|NCT00285779|147236651|OTHER|||||||0.063|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.063
73844928|NCT00285779|147236651|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline||||>0.9999
73844929|NCT00285779|147236652|OTHER|||||||0.063|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.063
73844930|NCT00285779|147236652|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
73844931|NCT00285779|147236652|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.031
73844932|NCT00285779|147236652|OTHER|||||||0.32|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.32
73844933|NCT00285779|147236653|OTHER|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.094
73844934|NCT00285779|147236653|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
73844935|NCT00285779|147236653|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
73844936|NCT00285779|147236653|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
73844937|NCT00285779|147236654|OTHER|||||||0.63|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.63
74084311|NCT01525628|147721701|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|99.99|STANDARD_DEVIATION|38.7||0.0651|TWO_SIDED|90.0|78.33|127.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||127.64|78.33|0.0651
73844938|NCT00285779|147236654|OTHER|||||||0.38|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.38
73844939|NCT00285779|147236654|OTHER|||||||0.38|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.38
73844940|NCT00285779|147236654|OTHER|||||||0.5|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.50
73844941|NCT00285779|147236655|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.031
73844942|NCT00285779|147236655|OTHER|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.094
73844943|NCT00285779|147236655|OTHER|||||||0.039|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.039
73844944|NCT00285779|147236655|OTHER|||||||0.19|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.19
73844945|NCT00285779|147236656|OTHER|||||||0.26|||||||Paired t test|||Week 12 versus baseline||||0.26
73844946|NCT00285779|147236656|OTHER|||||||0.55|||||||Paired t test|||Week 12 versus baseline||||0.55
73844947|NCT00285779|147236656|OTHER|||||||0.18|||||||Paired t test|||Week 24 versus baseline||||0.18
73844948|NCT00285779|147236656|OTHER|||||||0.13|||||||Paired t test|||Week 24 versus baseline||||0.13
73844949|NCT00285779|147236657|OTHER|||||||0.51|||||||Paired t test|||Week 12 versus baseline||||0.51
73844950|NCT00285779|147236657|OTHER|||||||0.47|||||||Paired t test|||Week 24 versus baseline||||0.47
73844951|NCT00285779|147236657|OTHER|||||||0.087|||||||Paired t test|||Week 24 versus baseline||||0.087
73844952|NCT00285779|147236657|OTHER|||||||0.86|||||||Paired t test|||Week 24 versus baseline||||0.86
73844953|NCT00285779|147236658|OTHER|||||||0.033|||||||Paired t test|||Week 12 versus baseline||||0.033
73844954|NCT00285779|147236658|OTHER|||||||0.069|||||||Paired t test|||Week 12 versus baseline||||0.069
73844955|NCT00285779|147236658|OTHER|||||||0.015|||||||Paired t test|||Week 24 versus baseline||||0.015
73844956|NCT00285779|147236658|OTHER|||||||0.026|||||||Paired t test|||Week 24 versus baseline||||0.026
73844957|NCT01576783|147236680|OTHER|The reported p-value is for the comparison of the change in Linoleic acid (18:2n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-3.4|0.9||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.9|-3.4|<0.001
73844958|NCT01576783|147236680|OTHER|The reported p-value is for the comparison of the change in Arachidonic acid (20:4n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|2.2|||<|0.001|TWO_SIDED|95.0|1.7|2.8||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||2.8|1.7|<0.001
73844959|NCT01576783|147236680|OTHER|The reported p-value is for the comparison of the change in Total n-6 mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.4||||0.61|TWO_SIDED|95.0|-1.0|1.7||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.7|-1.0|0.61
73844960|NCT01576783|147236680|OTHER|The reported p-value is for the comparison of the change in α-linolenic acid (18:3n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0||||0.4|TWO_SIDED|95.0|-0.1|0.1||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.1|-0.1|0.40
73844961|NCT01576783|147236680|OTHER|The reported p-value is for the comparison of the change in Eicosapentaenoic acid (20:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0||||0.12|TWO_SIDED|95.0|0.0|0.1||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.1|0.0|0.12
74084312|NCT01525628|147721701|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.29|STANDARD_DEVIATION|34.3||0.5658|TWO_SIDED|90.0|62.5|98.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||98.07|62.50|0.5658
73844962|NCT01576783|147236680|OTHER|The reported p-value is for the comparison of the change in Docosapentaenoic acid (22:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.1|0.0||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.0|-0.1|<0.001
73844963|NCT01576783|147236680|OTHER|The reported p-value is for the comparison of the change in Docosahexaenoic acid (22:6n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|1.0|1.5||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.5|1.0|<0.001
73844964|NCT01576783|147236680|OTHER|The reported p-value is for the comparison of the change in Total n-3 between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|0.9|1.4||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.4|0.9|<0.001
73844965|NCT01576783|147236681|OTHER|The reported p-value is for the comparison of the change in n-6:n-3 ratio between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-5.5|-3.7||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||-3.7|-5.5|<0.001
73844966|NCT01576783|147236684|OTHER|The reported p-value is for the comparison of the change in Effortful Control Composite scores between groups (DHA+AA vs. Placebo).||||||0.13||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||.13
73844967|NCT01576783|147236684|OTHER|The reported p-value is for the comparison of the change in Activity Level Composite scores between groups (DHA+AA vs. Placebo).||||||0.76||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||||||.76
73844968|NCT01576783|147236685|OTHER|The reported p-value is for the comparison of the change in Cognitive Composite scores between groups (DHA+AA vs. Placebo).||||||0.66||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.66
73844969|NCT01576783|147236685|OTHER|The reported p-value is for the comparison of the change in Language Composite scores between groups (DHA+AA vs. Placebo).||||||0.55||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.55
73844970|NCT01576783|147236685|OTHER|The reported p-value is for the comparison of the change in Motor Composite scores between groups (DHA+AA vs. Placebo).||||||0.88||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.88
73844971|NCT01576783|147236686|OTHER|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.11||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||.11
73844972|NCT01576783|147236686|OTHER|The reported p-value is for the comparison of the change in daytime sleep duration between groups (DHA+AA vs. Placebo).||||||0.47||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||0.47
73844973|NCT01576783|147236686|OTHER|The reported p-value is for the comparison of the change in total sleep duration between groups (DHA+AA vs. Placebo).||||||0.32||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||0.32
73844974|NCT01576783|147236687|OTHER|The reported p-value is for the comparison of the change in weight-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.99||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.99
73844975|NCT01576783|147236687|OTHER|The reported p-value is for the comparison of the change in length-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.27||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.27
73844976|NCT01576783|147236687|OTHER|The reported p-value is for the comparison of the change in head circumference-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.39||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.39
73844977|NCT01576783|147236687|OTHER|The reported p-value is for the comparison of the change in mid upper arm circumference-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.25||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.25
73844978|NCT01576783|147236687|OTHER|The reported p-value is for the comparison of the change in triceps skinfold-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.85||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.85
73844979|NCT01576783|147236687|OTHER|The reported p-value is for the comparison of the change in subscapular skinfold-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.82||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.82
73844980|NCT01576783|147236688|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.42||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.42
73844981|NCT01576783|147236688|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.68||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.68
73844982|NCT01576783|147236688|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.78||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.78
73844983|NCT01576783|147236688|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.32||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.32
73844984|NCT01576783|147236688|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.97||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.97
73844985|NCT01576783|147236688|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.62||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.62
73844986|NCT01576783|147236688|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.69||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.69
73959910|NCT02739035|147455211|SUPERIORITY|A difference of 10 degrees in total mean range of motion between the control and the treatment group was considered a clinically significant improvement.||||||0.23||||||Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.|t-test, 2 sided|||"Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib."||||0.23
73844987|NCT01576783|147236689|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.22||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.22
73844988|NCT01576783|147236690|OTHER|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.23||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.23
73844989|NCT01576783|147236690|OTHER|The reported p-value is for the comparison of the change in Daytime Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.07||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.07
73844990|NCT01576783|147236690|OTHER|The reported p-value is for the comparison of the change in Total Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.06||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.06
73844991|NCT01576783|147236691|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.51||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.51
73844992|NCT01576783|147236692|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.09||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.09
73844993|NCT01576783|147236693|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.29||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.29
73844994|NCT01576783|147236693|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.11||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.11
74084313|NCT01525628|147721701|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|108.25|STANDARD_DEVIATION|37.2||0.1286|TWO_SIDED|90.0|87.46|133.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||133.99|87.46|0.1286
73844995|NCT01576783|147236693|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.23||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.23
73844996|NCT01576783|147236693|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.29||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.29
73844997|NCT01576783|147236693|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.06||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.06
73844998|NCT01576783|147236693|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.14||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.14
73844999|NCT01576783|147236693|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.13||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.13
73845000|NCT01576783|147236693|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.16||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.16
73845001|NCT01576783|147236694|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.98|||||||Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.98
73845002|NCT01576783|147236694|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.67||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.67
73845003|NCT01576783|147236695|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.047||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.047
73845004|NCT01576783|147236696|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.2||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.20
73845005|NCT01576783|147236697|OTHER|Results are the comparison of proportion of those with a developmental condition between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).|Odds Ratio (OR)|1.63|||||TWO_SIDED|95.0|0.8|3.32||||||||3.32|0.80|
73845006|NCT01576783|147236698|OTHER|Results are the comparison of proportion of those with a behavioral condition between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).|Odds Ratio (OR)|4.5|||||TWO_SIDED|95.0|0.52|39.15||||||||39.15|0.52|
73845007|NCT02180828|147236765|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.925|||||||Chi-squared|||||||0.925
73845008|NCT02180828|147236766|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.298|||||||Chi-squared|||||||0.298
73845009|NCT02180828|147236767|NON_INFERIORITY_OR_EQUIVALENCE|90% power and a two-sided alpha level of 0.05||||||0.147|||||||Chi-squared|||||||0.147
73845010|NCT02180828|147236768|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.147|||||||Chi-squared|||||||0.147
73845011|NCT02180828|147236769|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
73845012|NCT02180828|147236770|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
73845013|NCT02180828|147236771|SUPERIORITY_OR_OTHER|||||||0.658|||||||Chi-squared|||||||0.658
73845014|NCT02180828|147236772|SUPERIORITY_OR_OTHER|||||||0.123|||||||Chi-squared|||||||0.123
73845015|NCT02180828|147236773|SUPERIORITY_OR_OTHER|||||||0.274|||||||Chi-squared|||||||0.274
73845016|NCT03801525|147236777|SUPERIORITY||Hazard Ratio (HR)|0.778||||0.696|TWO_SIDED|95.0|0.219|2.755|||Log Rank|||||2.755|0.219|0.6960
73845017|NCT03801525|147236784|SUPERIORITY||Hazard Ratio (HR)|0.201||||0.1038|TWO_SIDED|95.0|0.023|1.721|||Log Rank|||||1.721|0.023|0.1038
73898536|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.186||0.358|TWO_SIDED|95.0|-0.536|0.194||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.194|-0.536|0.358
73845018|NCT02410772|147236942|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|1.0||||0.05|TWO_SIDED|95.0|-2.6|4.5||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||4.5|-2.6|0.05
73845019|NCT02410772|147236942|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|3.0||||0.05|TWO_SIDED|95.0|-0.6|6.6|||Cochran-Mantel-Haenszel|For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||6.6|-0.6|0.05
73845020|NCT02410772|147236943|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|2.0||||0.05|TWO_SIDED|95.0|-1.1|5.1||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||5.1|-1.1|0.05
73845021|NCT02410772|147236943|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|4.4||||0.05|TWO_SIDED|95.0|1.2|7.7||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||7.7|1.2|0.05
73845022|NCT02410772|147236944|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than, then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|-0.6||||0.05|TWO_SIDED|95.0|-4.3|3.2||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary Safety endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||3.2|-4.3|0.05
73898537|NCT02880956|147328897|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74084314|NCT01525628|147721701|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|87.59|STANDARD_DEVIATION|31.8||0.1898|TWO_SIDED|90.0|73.56|104.3|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||104.30|73.56|0.1898
73845023|NCT02410772|147236944|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than, then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|-5.1||||0.05|TWO_SIDED|95.0|-8.7|-1.5||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary Safety endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||-1.5|-8.7|0.05
73845024|NCT02410772|147236949|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-2.45|4.63||||||||4.63|-2.45|
73845025|NCT02410772|147236949|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|4.12|||||TWO_SIDED|95.0|0.45|7.79||||||||7.79|0.45|
73845026|NCT02410772|147236950|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|1.05|||||TWO_SIDED|95.0|-2.01|4.11||||||||4.11|-2.01|
73845027|NCT02410772|147236950|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066)|Risk Difference (RD)|3.66|||||TWO_SIDED|95.0|0.42|6.9||||||||6.90|0.42|
73845028|NCT02410772|147236952|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|3.0|||||TWO_SIDED|95.0|-0.6|6.6||||||||6.6|-0.6|
73845029|NCT02410772|147236952|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|2.29|||||TWO_SIDED|95.0|-1.12|5.7||||||||5.70|-1.12|
73845030|NCT02410772|147236953|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|5.9|||||TWO_SIDED|95.0|2.8|8.9||||||||8.9|2.8|
73845031|NCT02410772|147236953|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|0.5|6.3||||||||6.3|0.5|
73845032|NCT05067335|147236954|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|9.37|STANDARD_ERROR_OF_MEAN|0.524|<|0.001|TWO_SIDED|95.0|8.34|10.39|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||10.39|8.34|<0.001
73845033|NCT05067335|147236957|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|2.86|STANDARD_ERROR_OF_MEAN|0.348|<|0.001|TWO_SIDED|95.0|2.18|3.54|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||3.54|2.18|<0.001
73845034|NCT05067335|147236958|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|3.48|STANDARD_ERROR_OF_MEAN|0.458|<|0.001|TWO_SIDED|95.0|2.58|4.38|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||4.38|2.58|<0.001
73845035|NCT00560417|147236976|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin was prespecified at 0.4%|Mean Difference (Final Values)|0.22|||||TWO_SIDED|95.0|0.06|0.38|||ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group.||||0.38|0.06|
73845036|NCT00560417|147236977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.003|TWO_SIDED|95.0|0.08|0.39||p-value is for 24 weeks.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.39|0.08|0.003
73845037|NCT00560417|147236977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value is for Endpoint (LOCF)|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.38|0.06|0.008
73845038|NCT00560417|147236978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.003|TWO_SIDED|95.0|0.08|0.39||p-value is for 24 Weeks change.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.39|0.08|0.003
73845039|NCT00560417|147236978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value is for Endpoint (LOCF) Change.|ANCOVA|||||0.38|0.06|0.008
73845040|NCT00560417|147236979|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||p-value is for Week 12: HbA1c \<7.0%|Fisher Exact|||||||0.561
73845041|NCT00560417|147236979|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||p-value is for Week 12: HbA1c \<=6.5%|Fisher Exact|||||||0.511
73845042|NCT00560417|147236979|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||p-value is for Week 18: HbA1c \<7.0%|Fisher Exact|||||||0.012
73845043|NCT00560417|147236979|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||p-value is for Week 18: HbA1c \<=6.5%|Fisher Exact|||||||0.269
73845044|NCT00560417|147236979|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||p-value is for Week 24: HbA1c \<7.0%|Fisher Exact|||||||0.161
73845045|NCT00560417|147236979|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||p-value is for Week 24: HbA1c \<=6.5%|Fisher Exact|||||||0.071
73845046|NCT00560417|147236979|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||p-value is for Endpoint (LOCF): HbA1c \<7.0%|Fisher Exact|||||||0.177
73845047|NCT00560417|147236979|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||p-value is for Endpoint (LOCF): HbA1c \<=6.5%|Fisher Exact|||||||0.060
73845048|NCT00560417|147236980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.28||||0.179|TWO_SIDED|95.0|-1.97|10.53||p-value is for Endpoint Morning Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||10.53|-1.97|0.179
73845049|NCT00560417|147236980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.96|||<|0.001|TWO_SIDED|95.0|5.72|22.19||p-value is for Endpoint Morning Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||22.19|5.72|<0.001
73845050|NCT00560417|147236980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.325|TWO_SIDED|95.0|-3.79|11.39||p-value is for Endpoint Midday Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||11.39|-3.79|0.325
73845051|NCT00560417|147236980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.73||||0.051|TWO_SIDED|95.0|-0.04|17.5||p-value is for Endpoint Midday Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||17.50|-0.04|0.051
73845052|NCT00560417|147236980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.92||||0.003|TWO_SIDED|95.0|3.66|18.19||p-value is for Endpoint Evening Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||18.19|3.66|0.003
73845053|NCT00560417|147236980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.19||||0.002|TWO_SIDED|95.0|5.44|22.94||p-value is for Endpoint Evening Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||22.94|5.44|0.002
73845054|NCT00560417|147236980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.03||||0.415|TWO_SIDED|95.0|-10.35|4.28||p-value is for Endpoint 0300 Hours.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||4.28|-10.35|0.415
73845055|NCT00560417|147236980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.39||||0.015|TWO_SIDED|95.0|1.46|13.32||p-value is for Endpoint Daily Mean 7-Point Blood Glucose.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||13.32|1.46|0.015
73845056|NCT00560417|147236980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.12||||0.021|TWO_SIDED|95.0|1.1|13.14||p-value is for Endpoint Daily Mean Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||13.14|1.10|0.021
73845057|NCT00560417|147236980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.97|||<|0.001|TWO_SIDED|95.0|5.01|18.93||p-value is for Endpoint Daily Mean Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||18.93|5.01|<0.001
73971424|NCT05194956|147483624|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-3.4||||0.0439|TWO_SIDED|95.0|-6.69|-0.12||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-0.12|-6.69|0.0439
74084315|NCT01525628|147721701|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.42|STANDARD_DEVIATION|36.3||0.5575|TWO_SIDED|90.0|61.81|99.51|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||99.51|61.81|0.5575
74084316|NCT03298880|147721753|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|2.1|5.3|||mixed linear regression|||||5.3|2.1|<0.001
73845058|NCT00560417|147236981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27||||0.131|TWO_SIDED|95.0|-0.68|5.22||p-value is for Baseline.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group||||5.22|-0.68|0.131
73845059|NCT00560417|147236981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|||<|0.001|TWO_SIDED|95.0|2.82|9.16||p-value is for Endpoint.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group||||9.16|2.82|<0.001
73845060|NCT00560417|147236982|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||p-value is for all reported hypoglycemic events at endpoint.|Fisher Exact|||||||0.826
73845061|NCT00560417|147236982|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||p-value is for all reported hypoglycemic events overall.|Fisher Exact|||||||0.394
73845062|NCT00560417|147236982|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||p-value is for non-nocturnal hypoglycemic events at endpoint.|Fisher Exact|||||||0.070
73845063|NCT00560417|147236982|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||p-value is for non-nocturnal hypoglycemic events overall.|Fisher Exact|||||||0.133
73845064|NCT00560417|147236982|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for nocturnal hypoglycemic events at endpoint.|Fisher Exact|||||||0.013
73845065|NCT00560417|147236982|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||p-value is for nocturnal hypoglycemic events overall.|Fisher Exact|||||||0.061
73845066|NCT00560417|147236982|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||p-value is for severe hypoglycemic events overall.|Fisher Exact|||||||0.248
73845067|NCT00560417|147236983|SUPERIORITY_OR_OTHER|||||||0.628||95.0||||p-value is for All reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.628
73845068|NCT00560417|147236983|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||p-value is for All reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.570
73845069|NCT00560417|147236983|SUPERIORITY_OR_OTHER|||||||0.116||95.0||||p-value is for Non-Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.116
73845070|NCT00560417|147236983|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value is for Non-Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.044
73845071|NCT00560417|147236983|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.006
73845072|NCT00560417|147236983|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.004
74084317|NCT03298880|147721753|SUPERIORITY||Mean Difference (Net)|2.3||||0.003|TWO_SIDED|95.0|0.8|3.8|||mixed linear regression|||||3.8|0.8|0.003
74084318|NCT01225055|147721871|SUPERIORITY|||||||0.84||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.84
73845073|NCT00560417|147236984|SUPERIORITY_OR_OTHER|||||||0.343||95.0||||p-value is for endpoint.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group (Type III sums of squares)||||||0.343
73845074|NCT00560417|147236985|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||p-value is for the change in body weight at endpoint in the ILPS treatment group.|t-test, 2 sided|||||||0.417
73845075|NCT00560417|147236985|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||p-value is for the change in body weight at endpoint in the glargine treatment group.|t-test, 2 sided|||||||0.041
73845076|NCT00560417|147236985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.343|TWO_SIDED|95.0|-1.15|0.4||p-value is for change in body weight at endpoint between ILPS and glargine treatment groups.|ANOVA|||||0.40|-1.15|0.343
73845077|NCT00560417|147236986|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Variable = Treatment + Baseline HbA1c Group+ Baseline SU Group||||||<0.001
73845078|NCT02164864|147236992|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.42|0.63||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the first step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 110mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority.||0.63|0.42|<0.0001
73845079|NCT02164864|147236992|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.58|0.88||P-values for non-inferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the second step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 150mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority||0.88|0.58|<.0001
73845080|NCT02164864|147236992|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.42|0.63||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the fourth step in hierarchy.||0.63|0.42|<0.001
73959911|NCT02739035|147455212|SUPERIORITY|A difference of 10 degrees in total mean range of motion (ROM) between the control and the treatment group was considered a clinically significant improvement. To detect this difference, a previous study's mean and standard deviation were referenced in order to predict the variation of results. 54 patients per arm were required to have 90% power with a two-sided t-test and a type I error rate of 5%. 130 patients were targeted for recruitment to account for up to a 20% dropout rate.||||||0.81||||||Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.|t-test, 2 sided|||"Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib."||||0.81
74084319|NCT01225055|147721871|SUPERIORITY|||||||0.64||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.64
74084320|NCT01225055|147721871|SUPERIORITY|||||||0.26||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.26
73845081|NCT02164864|147236992|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.58|0.88||unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Regression, Cox|Wald 2-sided p-value from (unstratified) Cox proportional hazards model||A pre-defined hierarchical testing approach was used. This was the sixth step in hierarchy.|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|0.88|0.58|0.0020
73845082|NCT02164864|147236993|OTHER||Hazard Ratio (HR)|0.99||||0.9862|TWO_SIDED|95.0|0.25|3.95||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||3.95|0.25|0.9862
73845083|NCT02164864|147236993|OTHER|Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Hazard Ratio (HR)|1.59||||0.5277|TWO_SIDED|95.0|0.38|6.64|||Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||6.64|0.38|0.5277
73845084|NCT02164864|147236994|OTHER||Hazard Ratio (HR)|1.06||||0.8853|TWO_SIDED|95.0|0.5|2.25||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.25|0.50|0.8853
73845085|NCT02164864|147236994|OTHER||Hazard Ratio (HR)|0.49||||0.238|TWO_SIDED|95.0|0.15|1.61||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.61|0.15|0.2380
73845086|NCT02164864|147236995|OTHER||Hazard Ratio (HR)|1.17||||0.5252|TWO_SIDED|95.0|0.72|1.88||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.88|0.72|0.5252
74084321|NCT01225055|147721872|SUPERIORITY|||||||0.64||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.64
74084322|NCT01225055|147721872|SUPERIORITY|||||||0||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.00
73845087|NCT02164864|147236995|OTHER||Hazard Ratio (HR)|0.84||||0.567|TWO_SIDED|95.0|0.47|1.51||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.51|0.47|0.5670
73845088|NCT02164864|147236996|OTHER||Hazard Ratio (HR)|1.12||||0.5579|TWO_SIDED|95.0|0.76|1.65||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.65|0.76|0.5579
73845089|NCT02164864|147236996|OTHER||Hazard Ratio (HR)|0.83||||0.4414|TWO_SIDED|95.0|0.51|1.34||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.34|0.51|0.4414
73845090|NCT02164864|147236997|OTHER|Wald 2-sided p-value from (stratified) Cox proportional hazards model|Hazard Ratio (HR)|1.51||||0.0861|TWO_SIDED|95.0|0.94|2.41|||Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.41|0.94|0.0861
73845091|NCT02164864|147236997|OTHER||Hazard Ratio (HR)|1.16||||0.6144|TWO_SIDED|95.0|0.66|2.04||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.04|0.66|0.6144
73845092|NCT02164864|147236998|OTHER||Hazard Ratio (HR)|1.3||||0.4803|TWO_SIDED|95.0|0.63|2.67||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.67|0.63|0.4803
73845093|NCT02164864|147236998|OTHER||Hazard Ratio (HR)|1.09||||0.8537|TWO_SIDED|95.0|0.42|2.83||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.83|0.42|0.8537
73845094|NCT02164864|147236999|OTHER||Hazard Ratio (HR)|0.94||||0.9388|TWO_SIDED|95.0|0.19|4.66||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||4.66|0.19|0.9388
73845095|NCT02164864|147236999|OTHER||Hazard Ratio (HR)|0.3||||0.303|TWO_SIDED|95.0|0.03|2.93||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.93|0.03|0.3030
73959912|NCT01215695|147455230|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73845096|NCT02164864|147237000|OTHER||Hazard Ratio (HR)|1.86||||0.1546|TWO_SIDED|95.0|0.79|4.4||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||4.40|0.79|0.1546
73845097|NCT02164864|147237000|OTHER||Hazard Ratio (HR)|0.99||||0.9789|TWO_SIDED|95.0|0.35|2.81||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.81|0.35|0.9789
73845098|NCT02164864|147237001|OTHER||Hazard Ratio (HR)|1.34||||0.0484|TWO_SIDED|95.0|1.0|1.79||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.79|1.00|0.0484
73845099|NCT02164864|147237001|OTHER||Hazard Ratio (HR)|1.03||||0.8903|TWO_SIDED|95.0|0.71|1.47||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.47|0.71|0.8903
73845100|NCT02164864|147237002|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.17||||0.1128|TWO_SIDED|95.0|0.9|1.53||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the fifth step in hierarchy.||1.53|0.90|0.1128
73898538|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.19||0.347|TWO_SIDED|95.0|-0.553|0.195||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.195|-0.553|0.347
73959913|NCT01215695|147455231|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73959914|NCT01215695|147455232|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
73959915|NCT01215695|147455233|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
73959916|NCT01215695|147455234|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73959917|NCT00667745|147455241|SUPERIORITY||F value, main effect|0.94||||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
74084323|NCT01225055|147721872|SUPERIORITY|||||||0.09||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.09
73845101|NCT02164864|147237002|OTHER||Hazard Ratio (HR)|1.3||||0.072|TWO_SIDED|95.0|0.98|1.73||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.73|0.98|0.0720
73845102|NCT02164864|147237002|OTHER||Hazard Ratio (HR)|0.97||||0.875|TWO_SIDED|95.0|0.68|1.39||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.39|0.68|0.8750
73845103|NCT02164864|147237003|OTHER||Hazard Ratio (HR)|1.09||||0.608|TWO_SIDED|95.0|0.79|1.51||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.51|0.79|0.6080
73845104|NCT02164864|147237003|OTHER||Hazard Ratio (HR)|0.96||||0.8348|TWO_SIDED|95.0|0.65|1.41||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.41|0.65|0.8348
73845105|NCT02164864|147237004|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.04||||0.0047|TWO_SIDED|95.0|0.84|1.29||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the third step in hierarchy.||1.29|0.84|0.0047
73845106|NCT02164864|147237004|OTHER||Hazard Ratio (HR)|1.13||||0.3002|TWO_SIDED|95.0|0.9|1.43||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.43|0.90|0.3002
73845107|NCT02164864|147237004|OTHER||Hazard Ratio (HR)|0.89||||0.4432|TWO_SIDED|95.0|0.67|1.19||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.19|0.67|0.4432
73845108|NCT00261833|147237007|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.618||||0.029|TWO_SIDED|95.0|-0.024|1.261||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira minus placebo (ie, the lower bound of the 95% confidence interval \[CI\] being greater than zero) will indicate superiority of Zemaira compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC+FRC combined) was a linear mixed model with country, inspiration state, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.261|-0.024|0.029
73845109|NCT00261833|147237007|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.74||||0.017|TWO_SIDED|95.0|0.059|1.42||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.420|0.059|0.017
73959918|NCT00667745|147455242|SUPERIORITY||Chi-squared|0.0||||0.967|TWO_SIDED||||||Chi-squared|||||||0.967
73845110|NCT00261833|147237007|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.478||||0.09|TWO_SIDED|95.0|-0.223|1.18||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (FRC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.180|-0.223|0.090
73845111|NCT00261833|147237011|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.04||||0.058|TWO_SIDED|95.0|-0.26|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC+FRC combined) from baseline to Month 24 was a mixed effects analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect at a 1-sided significance level of 0.025.||2.34|-0.26|0.058
73898539|NCT02880956|147328897|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
74084324|NCT01225055|147721873|SUPERIORITY|||||||0.72||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.72
73959919|NCT00667745|147455243|SUPERIORITY||Mean Difference (Net)|0.45||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
73959920|NCT00667745|147455244|SUPERIORITY||Mean Difference (Net)|0.02||||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.88
73971425|NCT05194956|147483624|SUPERIORITY|Sequence effects||||||0.3878|||||||ANOVA|||||||0.3878
73845112|NCT00261833|147237011|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.32||||0.028|TWO_SIDED|95.0|-0.03|2.67||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (i.e., the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects at a 1-sided significance level of 0.025.||2.67|-0.03|0.028
73845113|NCT00261833|147237011|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.89||||0.115|TWO_SIDED|95.0|-0.57|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (FRC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects as a repeated random effect at a 1-sided significance level of 0.025.||2.34|-0.57|0.115
73845114|NCT04358406|147237024|SUPERIORITY||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
73845115|NCT04358406|147237024|SUPERIORITY||||||>|0.1|||||||Chi-squared|||||||>0.1
73845116|NCT05528770|147237046|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|8.98||0.4291|TWO_SIDED|95.0|-3.8|8.3|||t-test, 2 sided|||||8.3|-3.8|0.4291
73845117|NCT02037529|147237063|SUPERIORITY|||||||0.5623|||||||Log Rank|||||||0.5623
73845118|NCT02037529|147237068|SUPERIORITY|||||||0.984|||||||Log Rank|||||||0.9840
73845119|NCT02037529|147237069|SUPERIORITY|||||||0.5968|||||||Log Rank|||||||0.5968
73845120|NCT00718315|147237077|SUPERIORITY_OR_OTHER|||||||0.481||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.481
73845121|NCT00718315|147237077|SUPERIORITY_OR_OTHER|||||||0.933||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.933
73845122|NCT00718315|147237077|SUPERIORITY_OR_OTHER|||||||0.986||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.986
73845123|NCT00718315|147237079|SUPERIORITY_OR_OTHER|||||||0.095|||||||Log Rank|||||||0.095
73845124|NCT00718315|147237080|SUPERIORITY_OR_OTHER|||||||0.199|||||||Chi-squared|||||||0.199
73845125|NCT00718315|147237081|SUPERIORITY_OR_OTHER|||||||0.108|||||||Chi-squared|||||||0.108
73845126|NCT00718315|147237082|SUPERIORITY_OR_OTHER|||||||0.179|||||||Chi-squared|||||||0.179
73845127|NCT00718315|147237083|SUPERIORITY_OR_OTHER|||||||0.066|||||||Kruskal-Wallis|||||||0.066
73845128|NCT00718315|147237084|SUPERIORITY_OR_OTHER|||||||0.087|||||||Kruskal-Wallis|||||||0.087
73845129|NCT00718315|147237085|SUPERIORITY_OR_OTHER|||||||0.308|||||||Kruskal-Wallis|||||||0.308
73845130|NCT03229538|147237090|OTHER||Adjusted Odds Ratio|0.86||||0.14|TWO_SIDED|95.0|0.71|1.05|||Regression, Logistic|||||1.05|0.71|0.14
73959921|NCT00667745|147455245|SUPERIORITY||Mean Difference (Net)|0.92||||0.49|TWO_SIDED|||||Value shown above describes emergent suicidal ideation for participants with baseline MSSI = 0. P=.36 describes exacerbation of baseline suicidal ideation for those with baseline MSSI \> 0.|Mixed Models Analysis|||||||.49
73845131|NCT03229538|147237090|OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-2.6|0.9|||||Difference = Methylprednisolone - Placebo|Rank = 97||0.9|-2.6|
73845132|NCT03229538|147237090|OTHER||Percent Difference|-1.5|||||TWO_SIDED|95.0|-3.5|0.5|||||Difference = Methylprednisolone - Placebo|Rank \> or = 96||0.5|-3.5|
73845133|NCT03229538|147237090|OTHER||Percent Difference|-2.2|||||TWO_SIDED|95.0|-4.4|0.1|||||Difference = Methylprednisolone - Placebo|Rank \> or = 95||0.1|-4.4|
73845134|NCT03229538|147237090|OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-4.3|2.7|||||Difference = Methylprednisolone - Placebo|Rank \> or = 94||2.7|-4.3|
73845135|NCT03229538|147237090|OTHER||Percent Difference|-3.8|||||TWO_SIDED|95.0|-7.8|0.2|||||Difference = Methylprednisolone - Placebo|Rank \> or = 93||0.2|-7.8|
73845136|NCT03229538|147237090|OTHER||Percent Difference|-3.4|||||TWO_SIDED|95.0|-7.8|0.9|||||Difference = Methylprednisolone - Placebo|Rank \> or = 92||0.9|-7.8|
73845137|NCT03229538|147237090|OTHER||Percent Difference|-3.1|||||TWO_SIDED|95.0|-7.5|1.3|||||Difference = Methylprednisolone - Placebo|Rank \> or = 91||1.3|-7.5|
73845138|NCT03229538|147237091|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone.|Adjusted Odds Ratio|0.74||||0.428|TWO_SIDED|95.0|0.34|1.57|||Regression, Logistic|||||1.57|0.34|0.428
73845139|NCT03229538|147237092|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone.|Adjusted Odds Ratio|0.83||||0.228|TWO_SIDED|95.0|0.61|1.13|||Regression, Logistic|||||1.13|0.61|0.228
73845140|NCT03229538|147237093|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Percent Difference|-1.8|||||TWO_SIDED|95.0|-4.0|0.4||||||||0.4|-4.0|
73845141|NCT03229538|147237094|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Adjusted Odds Ratio|0.79||||0.309|TWO_SIDED|95.0|0.5|1.25|||Regression, Logistic|||||1.25|0.50|0.309
73845142|NCT03229538|147237095|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Adjusted Odds Ratio|0.91||||0.723|TWO_SIDED|95.0|0.52|1.57|||Regression, Logistic|||||1.57|0.52|0.723
73845143|NCT03229538|147237097|SUPERIORITY||Adjusted Odds Ratio|0.86||||0.256|TWO_SIDED|95.0|0.67|1.11|||Regression, Logistic|||||1.11|0.67|0.256
73845144|NCT02621892|147237103|SUPERIORITY||Risk Difference (RD)|8.31|||<|0.02|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.02
73845145|NCT02621892|147237105|SUPERIORITY||Risk Difference (RD)|10.86|||<|0.008|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.008
73845146|NCT02621892|147237106|SUPERIORITY||Risk Difference (RD)|10.34|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73845147|NCT02621892|147237107|SUPERIORITY||Risk Difference (RD)|11.92|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73845148|NCT02621892|147237108|SUPERIORITY||Risk Difference (RD)|10.9|||<|0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.003
74084325|NCT01225055|147721873|SUPERIORITY|||||||0.58||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.58
73845149|NCT01164007|147237144|SUPERIORITY_OR_OTHER|||||||0.071|||||||One-sample exact binomial test|||The observed percentage of participants with CR or PR was compared with the expected proportion under the null hypothesis (0.10) and analyzed for statistical significance using a one-sample exact binomial test.||||0.071
73845150|NCT01816295|147237168|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73845151|NCT01816295|147237169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.1|STANDARD_ERROR_OF_MEAN|1.42|<|0.001|TWO_SIDED|99.5|1.05|9.07|||ANCOVA|||||9.07|1.05|<0.001
73845152|NCT01816295|147237170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|1.25||0.019|TWO_SIDED|99.5|-0.59|6.45|||ANCOVA|||||6.45|-0.59|0.019
73845153|NCT01816295|147237171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.34||0.442|TWO_SIDED|95.0|-0.94|0.41|||ANCOVA|||Change from Baseline to Week 12||0.41|-0.94|0.442
73845154|NCT01816295|147237171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.905|TWO_SIDED|95.0|-0.82|0.72|||ANCOVA|||Change from Baseline to Week 36||0.72|-0.82|0.905
73845155|NCT01259011|147237220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.05|TWO_SIDED|95.0|1.1|3.3|||Mixed Models Analysis|||||3.3|1.1|<.05
73845156|NCT01259011|147237221|SUPERIORITY||Slope|-1.2||||0.12|TWO_SIDED|95.0|-2.8|0.3||HADS-anxiety|Regression, Linear|||||0.3|-2.8|0.12
73845157|NCT01259011|147237221|SUPERIORITY||Slope|-2.2|||<|0.05|TWO_SIDED|95.0|-4.2|-0.3||HADS-depression|Regression, Linear|||||-0.3|-4.2|<0.05
73845158|NCT01259011|147237222|SUPERIORITY||Slope|-4.0||||0.21|TWO_SIDED|95.0|-10.2|2.2|||Regression, Linear|||||2.2|-10.2|0.21
73845159|NCT01911260|147237223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Growth Deficit who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."||||<0.05
73845160|NCT01911260|147237223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Normal Height who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."||||<0.05
73845161|NCT01138514|147237229|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|provides 85% power of success|equivalence ratio|98.77||||0.05|TWO_SIDED|90.0|95.2|102.5|||Fieller's method|||||102.5|95.2|0.05
73845162|NCT01138514|147237230|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|provides 85% power of success|equivalence ratio|100.27||||0.05|TWO_SIDED|90.0|95.6|105.2|||Fieller's method|||||105.2|95.6|0.05
73845163|NCT01138514|147237231|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Clinical success was defined as a score of clear (0) or almost clear (1) on Investigators Global Assessment (IGA) at Visit 4/Week 10"|equivalence difference|1.6||||0.05|TWO_SIDED|90.0|-4.2|7.4|||Wald's method Yates' continuity correct|||||7.4|-4.2|0.05
73845164|NCT00404248|147237282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.9|ONE_SIDED||||||t-test, 2 sided|||||||0.9
73845165|NCT00404248|147237283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.6
73845166|NCT00404248|147237284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.8|TWO_SIDED||||||t-test, 2 sided|||||||0.8
73845167|NCT01409096|147237407|SUPERIORITY_OR_OTHER|||||||0.9084|TWO_SIDED||||||ANCOVA|||Baseline HRSD scores used as covariate.||||0.9084
73845168|NCT01409096|147237408|SUPERIORITY_OR_OTHER|||||||0.5187|TWO_SIDED||||||ANCOVA|||Baseline IDS-SR used as a covariate.||||0.5187
73845169|NCT01409096|147237409|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED||||||ANOVA|||Baseline YMRS used as a covariate.||||0.6060
73845170|NCT01409096|147237410|SUPERIORITY_OR_OTHER|||||||0.511|TWO_SIDED||||||ANCOVA|||Baseline HRSA used as a covariate.||||0.5110
73845171|NCT00557193|147237436|SUPERIORITY||Hazard Ratio (HR)|1.107||||0.672|ONE_SIDED|85.0||1.403||A priori significance level threshold of alpha=0.15|Log Rank||Arm C is the numerator and Arm B is the denominator of the estimated hazard ratio|A one-sided log rank test will be used for testing whether the EFS in Arm C (chemo+lest) at DL2 is greater than the EFS in Arm B (chemo). This is equivalent to testing the null hypothesis of hazard ratio (HR)=1 versus the alternative of HR\<1.||1.403||0.672
73845172|NCT00976456|147237566|NON_INFERIORITY_OR_EQUIVALENCE|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time point.|Hazard Ratio (HR)|1.29||||0.0583|TWO_SIDED|95.0|0.989|1.682|||Wilcoxon (Mann-Whitney)|||||1.682|0.989|0.0583
73845173|NCT00976456|147237567|NON_INFERIORITY_OR_EQUIVALENCE|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time Point.|Hazard Ratio (HR)|1.091||||0.3869|TWO_SIDED|95.0|0.794|1.499|||Wilcoxon (Mann-Whitney)|||||1.499|0.794|0.3869
73845174|NCT02735200|147237571|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.9|TWO_SIDED|||||the p value correspond to the pretreatment time frame.|t-test, 2 sided|||||||0.9
73845175|NCT02735200|147237571|SUPERIORITY||Mean Difference (Final Values)|26.66|||<|0.001|TWO_SIDED|||||p value corresponds to the post treatment time frame.|t-test, 2 sided|||||||<0.001
73845176|NCT01463527|147237572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||||TWO_SIDED|95.0|0.17|0.57||||||Odds of intervention in capnography open group as compared to capnography blind group after adjusting of age and length of sedation.||0.57|0.17|
74084326|NCT01225055|147721873|SUPERIORITY|||||||0.44||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.44
74084327|NCT01225055|147721874|SUPERIORITY|||||||0.02||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.02
74084328|NCT01225055|147721874|SUPERIORITY|||||||0.1||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.10
73845177|NCT01463527|147237573|SUPERIORITY|||||||0.3|||||||GEE (Generalized Estimating Equation)|||||||0.30
73845178|NCT05136170|147237574|SUPERIORITY|The following null hypothesis was defined on this endpoint: the proportion of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min at week 4 in cenegermin (rhNGF) was lower or equal than control. The null hypothesis was rejected if the associated primary analysis p-value was lower than 0.025.|Odds Ratio (OR)|8.498||||0.002|TWO_SIDED|95.0|2.165|33.356||P-value of treatment variable from logistic regression model on proportion of patients reaching a value of Schirmer I test (without anesthesia) \>10mm/5min|Regression, Logistic|||Analysis was based on logistic regression model with multiple imputation (MI) under a missing not at random (MNAR) mechanism using retrieve dropouts with proportion of patients reaching a value of Schirmer I test \> 10 mm/5 min at Week 4 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||33.356|2.165|0.002
73845179|NCT05136170|147237575|SUPERIORITY|The following null hypothesis is defined on this endpoint: the change from baseline (reduction) in the global SANDE score at week 12 in cenegermin is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|Adjusted means difference|0.59||||0.89|TWO_SIDED|95.0|-7.801|8.981||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in the global SANDE score.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under a missing not at random (MNAR) mechanism using retrieve dropouts with change from baseline in the global SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline global SANDE score as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||8.981|-7.801|0.890
73845180|NCT05136170|147237576|SUPERIORITY|Analysis was based on logistic regression model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with proportion of patients reaching a value of Schirmer I test \>10 mm/5 min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.|Odds Ratio (OR)|6.648||||0.022|TWO_SIDED|95.0|1.307|33.808|||Regression, Logistic|||This key secondary endpoint was analyzed by means of a logistic regression model with proportion of patients reaching a value of Schirmer I test \>10mm/5min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as fixed effects and site as random effect.||33.808|1.307|0.022
73845181|NCT05136170|147237577|SUPERIORITY||Adjusted means difference|0.221||||0.962|TWO_SIDED|95.0|-8.934|9.377||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for severity at Week 12.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with change from baseline in the severity SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline severity SANDE score as qualitative independent variables.Site was considered as random effects that vary randomly among patients.||9.377|-8.934|0.962
73845182|NCT05136170|147237578|SUPERIORITY||Adjusted means difference|0.164||||0.973|TWO_SIDED|95.0|-9.221|9.549||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for frequency at Week 12.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with change from baseline in the frequency SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline frequency SANDE score as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||9.549|-9.221|0.973
73845183|NCT05136170|147237579|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|2.378||||0.52|TWO_SIDED|95.0|-4.869|9.625||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 4|Mixed Model for Repeated Measures|||QoL (Daily Activities) - Week 4||9.625|-4.869|0.52
73845184|NCT05136170|147237579|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|7.11||||0.073|TWO_SIDED|95.0|-0.653|14.873||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 12.|Mixed Model for Repeated Measures|||QoL (Daily Activities) - Week 12||14.873|-0.653|0.073
73845185|NCT05136170|147237579|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-4.166||||0.317|TWO_SIDED|95.0|-12.322|3.989||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Feelings) at Week 4.|Mixed Model for Repeated Measures|||QoL (Feelings) - Week 4||3.989|-12.322|0.317
74084329|NCT01225055|147721874|SUPERIORITY|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.04
73898540|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.494|TWO_SIDED|95.0|-0.205|0.423||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.423|-0.205|0.494
73959922|NCT00762619|147455246|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74084330|NCT01225055|147721875|SUPERIORITY|||||||0.01||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.01
73845186|NCT05136170|147237579|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixedmodel for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall"|LS means difference|1.058||||0.792|TWO_SIDED|95.0|-6.786|8.901||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Feelings) at Week 12.|Mixed Model for Repeated Measures|||QoL (Feelings) - Week 12||8.901|-6.786|0.792
73845187|NCT05136170|147237579|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM). Analyses included the fixed, categorical effects of treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall. Missing data will be imputed according to the questionnaire manuals"|LS means difference|-3.907||||0.488|TWO_SIDED|95.0|-14.948|7.135||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Work) at Week 4.|Mixed Model for Repeated Measures|||QoL (Work) - Week 4||7.135|-14.948|0.488
73845188|NCT05136170|147237579|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.284||||0.954|TWO_SIDED|95.0|-9.998|9.431||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Work) at Week 12.|Mixed Model for Repeated Measures|||QoL (Work) - Week 12||9.431|-9.998|0.954
73845189|NCT05136170|147237579|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEl module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.049||||0.99|TWO_SIDED|95.0|-7.658|7.559||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 4.|Mixed Model for Repeated Measures|||TS (Treatment - in general) - Week 4||7.559|-7.658|0.99
73845190|NCT05136170|147237579|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|1.976||||0.582|TWO_SIDED|95.0|-5.065|9.017||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 12.|Mixed Model for Repeated Measures|||TS (Treatment - in general) - Week 12||9.017|-5.065|0.582
73845191|NCT05136170|147237579|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|5.232||||0.125|TWO_SIDED|95.0|-1.457|11.922||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Symptom Bother Module at Week 4.|Mixed Model for Repeated Measures|||Symptom - Bother - Week 4||11.922|-1.457|0.125
73845192|NCT05136170|147237579|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.156||||0.964|TWO_SIDED|95.0|-6.912|6.6||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Symptom Bother Module at Week 12.|Mixed Model for Repeated Measures|||Symptom - Bother - Week 12||6.6|-6.912|0.964
73845193|NCT05136170|147237580|SUPERIORITY||LS means difference|0.795||||0.102|TWO_SIDED|95.0|-0.157|1.748||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 4.|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 4 was reported."||1.748|-0.157|0.102
73845194|NCT05136170|147237580|SUPERIORITY||LS means difference|-0.051||||0.923|TWO_SIDED|95.0|-1.094|0.991||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 8.|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 8 was reported."||0.991|-1.094|0.923
74084331|NCT01225055|147721875|SUPERIORITY|||||||0.34||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.34
74084332|NCT01225055|147721875|SUPERIORITY|||||||0.2||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.20
73959923|NCT00762619|147455247|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74084333|NCT01225055|147721876|SUPERIORITY|||||||0||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.00
74084334|NCT01225055|147721876|SUPERIORITY|||||||0.01||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.01
73845195|NCT05136170|147237580|SUPERIORITY||LS means difference|0.136||||0.787|TWO_SIDED|95.0|-0.849|1.12||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 12|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 12 was reported."||1.12|-0.849|0.787
73845196|NCT05136170|147237581|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||<0.001
73845197|NCT05136170|147237581|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 8 (Visit 4) was reported.||||<0.001
73845198|NCT05136170|147237581|SUPERIORITY|||||||0.014||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 12 (Visit 5) was reported.||||0.014
73845199|NCT05136170|147237581|SUPERIORITY|||||||0.095||||||Not statistically significant result. p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 16 (Visit 6) was reported.||||0.095
73845200|NCT05136170|147237582|SUPERIORITY|||||||0.02||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||0.02
73845201|NCT05136170|147237582|SUPERIORITY|||||||0.328||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 8 (Visit 4) was reported.||||0.328
73845202|NCT05136170|147237582|SUPERIORITY|||||||0.287||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 12 (Visit 5) was reported.||||0.287
73845203|NCT05136170|147237582|SUPERIORITY|||||||0.777||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 16 (Visit 6) was reported.||||0.777
74084335|NCT01225055|147721876|SUPERIORITY|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.04
74084336|NCT01653405|147721893|SUPERIORITY||||||<|0.001|||||||Difference in differences|||||||<0.001
73845204|NCT05136170|147237583|SUPERIORITY|||||||0.126||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||0.126
73845205|NCT05136170|147237583|SUPERIORITY|||||||0.968||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 8 (Visit 4) was reported.||||0.968
73845206|NCT05136170|147237583|SUPERIORITY|||||||0.613||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 12 (Visit 5) was reported.||||0.613
73845207|NCT05136170|147237583|SUPERIORITY|||||||0.805||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 16 (Visit 6) was reported.||||0.805
73845208|NCT05136170|147237584|SUPERIORITY|||||||0.543||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Global score - Week 8 (Visit 4) was reported.||||0.543
73845209|NCT05136170|147237584|SUPERIORITY|||||||0.677||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Global score - Week 12 (Visit 5) was reported.||||0.677
73845210|NCT05136170|147237584|SUPERIORITY|||||||0.914||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global score - Week 16 (Visit 6) was reported.||||0.914
73845211|NCT05136170|147237584|SUPERIORITY|||||||0.874||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Severity - Week 8 (Visit 4) was reported.||||0.874
73845212|NCT05136170|147237584|SUPERIORITY|||||||0.945||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 12 (Visit 5) was reported.||||0.945
73845213|NCT05136170|147237584|SUPERIORITY|||||||0.727||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 16 (Visit 6) was reported.||||0.727
73845214|NCT05136170|147237584|SUPERIORITY|||||||0.342||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 8 (Visit 4) was reported.||||0.342
73845215|NCT05136170|147237584|SUPERIORITY|||||||0.821||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 12 (Visit 5) was reported.||||0.821
73845216|NCT05136170|147237584|SUPERIORITY|||||||0.926||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 16 (Visit 6) was reported.||||0.926
74084337|NCT01653405|147721894|SUPERIORITY|||||||0.43|||||||test of differences|||||||0.43
74084338|NCT01653405|147721895|SUPERIORITY||||||<|0.001|||||||difference in differences|||||||<0.001
73845217|NCT05136170|147237585|SUPERIORITY|||||||0.0344||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores (SANDE global score) - Week 4 (Visit 3) was reported.||||0.0344
73845218|NCT05136170|147237585|SUPERIORITY|||||||1||||||p-value corresponds to a Fisher's exact test of the comparisons between Cenegermin and Vehicle in all patients.|Fisher Exact|||Herein analysis for NEI score \>= 50% - Week 4 (Visit 3) was reported.||||1
73845219|NCT05136170|147237585|SUPERIORITY|||||||0.0235||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores and/or NEI score \>= 50 - Week 4 (Visit 3) was reported.||||0.0235
73845220|NCT05136170|147237586|SUPERIORITY|||||||0.888||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Impact on Daily Activities) - Week 4 (Visit 3) was reported.||||0.888
73845221|NCT05136170|147237586|SUPERIORITY|||||||0.651||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Impact on Daily Activities) - Week 8 (Visit 4) was reported.||||0.651
73845222|NCT05136170|147237586|SUPERIORITY|||||||0.267||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Daily Activities) - Week 12 (Visit 5) was reported.||||0.267
73845223|NCT05136170|147237586|SUPERIORITY|||||||0.459||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Daily Activities) - Week 16 (Visit 6) was reported.||||0.459
73845224|NCT05136170|147237586|SUPERIORITY|||||||0.192||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 4 was reported.||||0.192
73845225|NCT05136170|147237586|SUPERIORITY|||||||0.568||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 8 was reported.||||0.568
74084339|NCT01653405|147721896|SUPERIORITY||||||<|0.001|||||||Difference in differences|||||||<0.001
74084340|NCT01653405|147721897|SUPERIORITY|||||||0.002|||||||difference in differences|||||||0.002
73845226|NCT05136170|147237586|SUPERIORITY|||||||0.871||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 12 was reported.||||0.871
73845227|NCT05136170|147237586|SUPERIORITY|||||||0.85||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 16 was reported.||||0.85
73845228|NCT05136170|147237586|SUPERIORITY|||||||0.364||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 4 was reported.||||0.364
73845229|NCT05136170|147237586|SUPERIORITY|||||||0.646||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 8 was reported.||||0.646
73845230|NCT05136170|147237586|SUPERIORITY|||||||0.739||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 12 was reported.||||0.739
73845231|NCT05136170|147237586|SUPERIORITY|||||||0.664||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 16 was reported.||||0.664
73845232|NCT05136170|147237586|SUPERIORITY|||||||0.846||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 4 was reported.||||0.846
73845233|NCT05136170|147237586|SUPERIORITY|||||||0.248||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 8 was reported.||||0.248
73845234|NCT05136170|147237586|SUPERIORITY|||||||0.341||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 12 was reported.||||0.341
73845235|NCT05136170|147237586|SUPERIORITY|||||||0.413||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 16 was reported.||||0.413
73959924|NCT00762619|147455248|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73971426|NCT05194956|147483624|SUPERIORITY|Period effects||||||0.9772|||||||ANOVA|||||||0.9772
74084341|NCT00715676|147721901|SUPERIORITY_OR_OTHER|||||||0.641||||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance||||0.641
74084342|NCT00715676|147721901|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance||||0.243
74084343|NCT00715676|147721902|SUPERIORITY_OR_OTHER|||||||0.778||95.0|||||ANOVA|||||||0.778
74084344|NCT00715676|147721902|SUPERIORITY_OR_OTHER|||||||0.173||95.0|||||ANOVA|||||||0.173
73845236|NCT05136170|147237586|SUPERIORITY|||||||0.927||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 4 was reported.||||0.927
73845237|NCT05136170|147237586|SUPERIORITY|||||||0.914||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 8 was reported.||||0.914
73845238|NCT05136170|147237586|SUPERIORITY|||||||0.564||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 12 was reported.||||0.564
73845239|NCT05136170|147237586|SUPERIORITY|||||||0.489||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 16 was reported.||||0.489
73845240|NCT05136170|147237586|SUPERIORITY|||||||0.082||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 4||||0.082
73845241|NCT05136170|147237586|SUPERIORITY|||||||0.848||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 8 was reported.||||0.848
73845242|NCT05136170|147237586|SUPERIORITY|||||||0.805||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 12 was reported.||||0.805
73845243|NCT05136170|147237586|SUPERIORITY|||||||0.833||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Symptom-Bother - Week 16 was reported.||||0.833
74022467|NCT00393718|147597237|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.4%. Superiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.0%.|Least Squares Mean|-0.5|||<|0.0001||95.0|-0.7|-0.3||p-value is for the null hypothesis for superiority. A significance level of a one-sided 2.5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included HbA1C at baseline as a covariate and treatment group and pre-trial treatment as fixed effects.~Hypothesis for non-inferiority:~H0: μ0.9 - μG ≥ 0.4, H1: μ0.9 - μG \< 0.4,~Hypothesis for superiority:~H0: μ0.9 - μG ≥ 0.0, H1: μ0.9 - μG \< 0.0, where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively. When non-inferiority was confirmed, superiority was evaluated based on the closed testing procedure."||-0.30|-0.70|<0.0001
74084345|NCT00715676|147721903|SUPERIORITY_OR_OTHER|||||||0.395||95.0|||||ANOVA|||||||0.395
74084346|NCT00715676|147721903|SUPERIORITY_OR_OTHER|||||||0.523||95.0|||||ANOVA|||||||0.523
74084347|NCT00715676|147721904|SUPERIORITY_OR_OTHER|||||||0.928||95.0|||||ANOVA|||||||0.928
73845244|NCT05136170|147237589|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||<0.001
73845245|NCT05136170|147237590|SUPERIORITY|||||||0.046||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||0.046
73845246|NCT05136170|147237591|SUPERIORITY|||||||0.34||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||0.34
73845247|NCT05136170|147237592|SUPERIORITY|||||||0.017||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global Score - Week 2 was reported||||0.017
73845248|NCT05136170|147237592|SUPERIORITY|||||||0.339||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global Score - Week 4 was reported||||0.339
73845249|NCT05136170|147237592|SUPERIORITY|||||||0.004||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Severity - Week 2 was reported.||||0.004
73845250|NCT05136170|147237592|SUPERIORITY|||||||0.292||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 4 was reported.||||0.292
73845251|NCT05136170|147237592|SUPERIORITY|||||||0.09||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 2 was reported.||||0.09
73845252|NCT05136170|147237592|SUPERIORITY|||||||0.54||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 4 was reported.||||0.54
73845253|NCT05136170|147237593|SUPERIORITY|||||||0.0064||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores (SANDE global score) was reported.||||0.0064
73845254|NCT05136170|147237593|SUPERIORITY|||||||1||||||p-value corresponds to a Fisher's exact test of the comparisons between Cenegermin and Vehicle in all patients.|Fisher Exact|||Herein analysis for NEI score \>= 50% was reported.||||1
73959925|NCT00762619|147455249|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74084348|NCT00715676|147721904|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||ANOVA|||||||0.124
74084349|NCT00715676|147721905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.173||||||90.0|0.164|0.181||||||||0.181|0.164|
74084350|NCT00715676|147721905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.582||||||90.0|0.573|0.591||||||||0.591|0.573|
73845255|NCT05136170|147237593|SUPERIORITY|||||||0.0034||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores and/or NEI score \>= 50 was reported.||||0.0034
73845256|NCT05136170|147237594|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||||||<0.001
73845257|NCT01977222|147237642|OTHER|||||||0.1673|||||||t-test, 2 sided|||||||0.1673
73845258|NCT01977222|147237643|OTHER|||||||0.5745|||||||t-test, 2 sided|||||||0.5745
73845259|NCT01977222|147237644|OTHER|||||||0.511|||||||t-test, 2 sided|||||||.511
73845260|NCT01977222|147237645|OTHER|||||||0.776|||||||t-test, 2 sided|||||||0.776
73845261|NCT01977222|147237646|OTHER|||||||0.5374|||||||t-test, 2 sided|||||||0.5374
73845262|NCT01977222|147237647|OTHER|||||||0.3385|||||||t-test, 2 sided|||||||0.3385
73845263|NCT01977222|147237648|OTHER|||||||0.0189|||||||t-test, 2 sided|||||||0.0189
74084351|NCT00372996|147721909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912||||0.56|TWO_SIDED|80.0|0.744|1.118|||Log Rank|2-sided p-value from an unstratified log-rank text|Hazard ratio was based on Cox proportional hazards model.|||1.118|0.744|0.560
74084352|NCT00372996|147721910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.331|TWO_SIDED|70.0|0.572|1.02||2-sided p-value from unstratified log-rank test|Log Rank||Hazard ratio was based on the Cox proportional hazards model.|||1.020|0.572|0.331
73845264|NCT01977222|147237649|OTHER|||||||0.1183|||||||t-test, 2 sided|||||||0.1183
73845265|NCT01605669|147237668|SUPERIORITY_OR_OTHER||Percentage Sensitivity|85.7||||||95.0||||||||||||
73845266|NCT01605669|147237668|SUPERIORITY_OR_OTHER||Percent Specificity|72.4||||||95.0||||||||||||
73845267|NCT01605669|147237668|SUPERIORITY_OR_OTHER||Percent Error Rate|25.0||||||95.0|||||||Error rate of 9/36 is equal to total of false positives plus false negatives over the total of participants analyzed.|||||
73845268|NCT00945659|147237676|SUPERIORITY||Mean Difference (Net)|-0.003|STANDARD_DEVIATION|0.2||0.86|TWO_SIDED|95.0|-0.43|0.36|||Generalized Estimating Equation|||||0.36|-0.43|0.86
73845269|NCT00945659|147237676|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.03|TWO_SIDED|95.0|-0.78|-0.04|||Generalized Estimating Equation|||||-0.04|-0.78|0.03
73845270|NCT00945659|147237677|SUPERIORITY||Mean Difference (Net)|-10.05|STANDARD_DEVIATION|4.72||0.03|TWO_SIDED|95.0|-19.3|-0.81|||Generalized Estimating Equation|||||-0.81|-19.30|0.03
73845271|NCT00945659|147237677|SUPERIORITY||Mean Difference (Net)|-0.82|STANDARD_DEVIATION|5.47||0.88|TWO_SIDED|95.0|-11.54|9.9|||Generalized Estimating Equation|||||9.9|-11.54|0.88
73845272|NCT00945659|147237678|SUPERIORITY||Generalized Estimating Equation|-3.45|STANDARD_DEVIATION|4.98||0.49|TWO_SIDED|95.0|-13.21|6.32|||Generalized Estimating Equation|||||6.32|-13.21|0.49
73845273|NCT00945659|147237678|SUPERIORITY||Mean Difference (Net)|2.53|STANDARD_DEVIATION|5.76||0.66|TWO_SIDED|95.0|||||Generalized Estimating Equation|||||||0.66
73845274|NCT00945659|147237679|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|0.86||0.64|TWO_SIDED|95.0|-1.29|2.08|||Generalized Estimating Equation|||||2.08|-1.29|0.64
73845275|NCT00945659|147237679|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_DEVIATION|0.92||0.65|TWO_SIDED|95.0|-2.22|1.39|||Generalized Estimating Equation|||||1.39|-2.22|0.65
73845276|NCT00945659|147237680|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_DEVIATION|63.4||0.99|TWO_SIDED|95.0|-123.56|124.97|||Generalized Estimating Equation|||||124.97|-123.56|0.99
73845277|NCT00945659|147237680|SUPERIORITY||Mean Difference (Net)|-1.22|STANDARD_DEVIATION|13.81||0.93|TWO_SIDED|95.0|-28.26|25.83|||Generalized Estimating Equation|||||25.83|-28.26|0.93
73845278|NCT00945659|147237681|SUPERIORITY||Mean Difference (Net)|1.17|STANDARD_DEVIATION|1.47||0.43|TWO_SIDED|95.0|-1.7|4.04|||Generalized Estimating Equation|||||4.04|-1.70|0.43
73845279|NCT00945659|147237681|SUPERIORITY||Mean Difference (Net)|-2.59|STANDARD_DEVIATION|1.87||0.08|TWO_SIDED|95.0|-5.5|0.32|||Generalized Estimating Equation|||||0.32|-5.50|0.08
73845280|NCT00945659|147237682|SUPERIORITY||Mean Difference (Net)|1.32|STANDARD_DEVIATION|1.66||0.43|TWO_SIDED|95.0|-1.94|4.56|||Generalized Estimating Equation|||||4.56|-1.94|0.43
73845281|NCT00945659|147237682|SUPERIORITY||Mean Difference (Net)|-3.71|STANDARD_DEVIATION|1.36||0.007|TWO_SIDED|95.0|-6.38|-1.04|||Generalized Estimating Equation|||||-1.04|-6.38|.007
73845282|NCT00945659|147237683|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.23||0.75|TWO_SIDED|95.0|-2.02|2.79|||Generalized Estimating Equation|||||2.79|-2.02|0.75
73845283|NCT00945659|147237683|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_DEVIATION|1.38||0.78|TWO_SIDED|95.0|-3.09|2.32|||Generalized Estimating Equation|||||2.32|-3.09|0.78
73845284|NCT00945659|147237684|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_DEVIATION|1.31||0.58|TWO_SIDED|95.0|-1.86|3.29|||Generalized Estimating Equation|||||3.29|-1.86|0.58
73845285|NCT00945659|147237684|SUPERIORITY||Mean Difference (Net)|-0.93|STANDARD_DEVIATION|1.14||0.41|TWO_SIDED|95.0|-3.17|1.3|||Generalized Estimating Equation|||||1.3|-3.17|0.41
73845286|NCT00945659|147237685|SUPERIORITY||Mean Difference (Net)|1.95|STANDARD_DEVIATION|2.66||0.46|TWO_SIDED|95.0|-3.26|7.15|||Generalized Estimating Equation|||||7.15|-3.26|0.46
73845287|NCT00945659|147237685|SUPERIORITY||Mean Difference (Net)|-3.01|STANDARD_DEVIATION|2.54||0.24|TWO_SIDED|95.0|-7.99|1.96|||Generalized Estimating Equation|||||1.96|-7.99|0.24
73845288|NCT00945659|147237686|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_DEVIATION|3.37||0.93|TWO_SIDED|95.0|-6.33|6.91|||Generalized Estimating Equation|||||6.91|-6.33|0.93
73845289|NCT00945659|147237686|SUPERIORITY||Mean Difference (Net)|-2.21|STANDARD_DEVIATION|2.95||0.45|TWO_SIDED|95.0|-8.01|3.57|||Generalized Estimating Equation|||||3.57|-8.01|0.45
73845290|NCT00945659|147237687|SUPERIORITY||Mean Difference (Net)|-0.77|STANDARD_DEVIATION|3.26||0.81|TWO_SIDED|95.0|-7.15|5.62|||Generalized Estimating Equestion|||||5.62|-7.15|0.81
73845291|NCT00945659|147237687|SUPERIORITY||Mean Difference (Net)|0.99|STANDARD_DEVIATION|2.63||0.72|TWO_SIDED|95.0|-4.11|6.08|||Generalized Estimating Equation|||||6.08|-4.11|0.72
74084353|NCT00372996|147721911|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.79||||0.463|TWO_SIDED|95.0|-8.0|17.6|||Pearson chi-square test|||||17.6|-8.0|0.463
74022468|NCT00393718|147597238|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.49||||||95.0|-0.71|-0.27|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-0.27|-0.71|
74022469|NCT00393718|147597239|SUPERIORITY_OR_OTHER||Least Squares Mean|-12.9|||<|0.0001||95.0|-18.2|-7.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-7.5|-18.2|<0.0001
74022470|NCT00393718|147597240|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.7||||||95.0|-18.6|-4.9|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-4.9|-18.6|
74084354|NCT01067521|147721925|SUPERIORITY||Risk Ratio (RR)|0.656|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.539|0.799||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo|"Relapses were estimated by a baseline-adjusted, Negative Binomial Regression with an offset based on the log of subject's exposure to treatment. The model included the following covariates: - Baseline EDSS score. - Log of the prior 2-year number of relapses. - Volume of T2 lesions at baseliner. - Status of Gd-enhancing T1 activity at baseline (=0 no Gd-enhancing T1 at baseline; =1 at least one Gd-enhancing T1 at baseline). - CGR."||0.799|0.539|<0.0001
74084355|NCT01067521|147721926|SUPERIORITY||Risk Ratio (RR)|0.653|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|0.546|0.78||The overall significance level for this study is 5%|Negative binomial regression||GA 40 mg vs. placebo|Negative binomial regression||0.780|0.546|<.0001
73845292|NCT00945659|147237688|SUPERIORITY||Mean Difference (Net)|0.99|STANDARD_DEVIATION|2.6||0.71|TWO_SIDED|95.0|-4.11|6.08|||Generalized Estimating Equation|||||6.08|-4.11|0.71
73845293|NCT00945659|147237688|SUPERIORITY||Mean Difference (Net)|-1.16|STANDARD_DEVIATION|2.85||0.68|TWO_SIDED|95.0|-6.74|4.43|||Generalized Estimating Equation|||||4.43|-6.74|0.68
73845294|NCT04562116|147237689|OTHER||Ratio|94.59||||0.5789|TWO_SIDED|90.0|79.57|112.45||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||112.45|79.57|0.5789
73845295|NCT04562116|147237689|OTHER||Ratio|99.34||||0.9468|TWO_SIDED|90.0|83.66|117.96||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||117.96|83.66|0.9468
74022471|NCT00393718|147597241|SUPERIORITY_OR_OTHER||Least Squares Mean|-93.05|||<|0.0001||95.0|-119.61|-66.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-66.50|-119.61|<0.0001
74022472|NCT00393718|147597242|SUPERIORITY_OR_OTHER||Least Squares Mean|-74.51||||||95.0|-105.75|-43.27|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-43.27|-105.75|
74022473|NCT00393718|147597243|SUPERIORITY_OR_OTHER||Least Squares Mean|-17.63|||<|0.0001||95.0|-25.0|-10.27||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-10.27|-25.00|<0.0001
74022474|NCT00393718|147597244|SUPERIORITY_OR_OTHER||Least Squares Mean|-17.21||||||95.0|-26.32|-8.09|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-8.09|-26.32|
73845296|NCT04562116|147237689|OTHER||Ratio|107.81||||0.1364|TWO_SIDED|90.0|99.14|117.24||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||117.24|99.14|0.1364
74084356|NCT01067521|147721927|SUPERIORITY||Risk Ratio (RR)|0.552|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.436|0.699||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo|||0.699|0.436|<0.0001
74084357|NCT01067521|147721928|SUPERIORITY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.048||0.2058|TWO_SIDED|95.0|-0.154|0.033||The overall significance level for this study is 5%|ANCOVA||GA 40 mg vs Placebo|||0.033|-0.154|0.2058
73845297|NCT04562116|147237689|OTHER||Ratio|92.13||||0.1915|TWO_SIDED|90.0|82.85|102.44||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||102.44|82.85|0.1915
73845298|NCT04562116|147237689|OTHER||Ratio|101.67||||0.5059|TWO_SIDED|90.0|97.41|106.12||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||106.12|97.41|0.5059
73845299|NCT04562116|147237690|OTHER||Ratio|95.82||||0.6665|TWO_SIDED|90.0|80.72|113.75||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||113.75|80.72|0.6665
73959926|NCT00762619|147455250|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845300|NCT04562116|147237690|OTHER||Ratio|99.15||||0.9316|TWO_SIDED|90.0|83.43|117.83||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||117.83|83.43|0.9316
73845301|NCT04562116|147237690|OTHER||Ratio|107.75||||0.1371|TWO_SIDED|90.0|99.12|117.13||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||117.13|99.12|0.1371
73845302|NCT04562116|147237690|OTHER||Ratio|88.66||||0.0962|TWO_SIDED|90.0|78.72|99.85||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||99.85|78.72|0.0962
73845303|NCT04562116|147237690|OTHER||Ratio|100.81||||0.6807|TWO_SIDED|90.0|97.45|104.29||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||104.29|97.45|0.6807
73845304|NCT04562116|147237691|OTHER||Ratio|91.22||||0.3431|TWO_SIDED|90.0|77.3|107.63||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||107.63|77.30|0.3431
73845305|NCT04562116|147237691|OTHER||Ratio|91.05||||0.4277|TWO_SIDED|90.0|74.33|111.53||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||111.53|74.33|0.4277
73845306|NCT04562116|147237691|OTHER||Ratio|94.79||||0.4963|TWO_SIDED|90.0|82.8|108.52||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||108.52|82.80|0.4963
73845307|NCT04562116|147237691|OTHER||Ratio|88.24||||0.1931|TWO_SIDED|90.0|75.08|103.7||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||103.70|75.08|0.1931
73845308|NCT04562116|147237691|OTHER||Ratio|92.94||||0.296|TWO_SIDED|90.0|82.51|104.69||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||104.69|82.51|0.2960
73845309|NCT00934921|147237702|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.1||||||90.0|91.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|91.2|
73845310|NCT00934921|147237703|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.2||||||90.0|88.8|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|88.8|
73845311|NCT00934921|147237704|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.9||||||90.0|89.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|89.5|
73845312|NCT03781479|147237705|OTHER||Mean Difference (Net)|0.792||||0.0083|TWO_SIDED|95.0|0.22|1.37|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments along with a 95% confidence interval for this difference.|A mixed effects liner model was fit with the HFMSE change from baseline (CFB) scores at Day 28 as a response and treatment, sequence, and treatment by sequence as fixed effect terms and patient as a random effect.||1.37|0.22|0.0083
73845313|NCT02921256|147237706|SUPERIORITY|||||||0.69|||||||Regression, Linear|||||||0.69
73845314|NCT02921256|147237706|SUPERIORITY|||||||0.26|||||||Regression, Linear|||||||0.26
73845315|NCT04211363|147237737|SUPERIORITY||Odds Ratio (OR)|20.69|||<|0.0001|TWO_SIDED|95.0|7.58|56.48|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data..|IGA Success Odds Ratio||56.48|7.58|<0.0001
73845316|NCT04211363|147237738|SUPERIORITY||Hazard Ratio (HR)|3.867|||<|0.0001|TWO_SIDED|95.0|2.795|5.351|||Log Rank|Unstratified log-rank test|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization.|Time to PASI-50||5.351|2.795|<0.0001
73845317|NCT04211363|147237739|SUPERIORITY||Odds Ratio (OR)|12.0|||<|0.0001|TWO_SIDED|95.0|5.15|27.93|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-75 at Week 8 Odds Ratio||27.93|5.15|<0.0001
73845318|NCT04211363|147237740|SUPERIORITY||Odds Ratio (OR)|17.9|||<|0.0001|TWO_SIDED|95.0|4.38|73.09|||Cochran-Mantel-Haenszel|Stratified by study site, baseline IGA score, and baseline intertriginous involvement with multiple imputation of missing data.|Cochran-Mantel-Haenszel stratified by study site, baseline IGA score, and baseline intertriginous involvement with multiple imputation of missing data.|PASI-90 at Week 8 Odds Ratio||73.09|4.38|<0.0001
73845319|NCT04211363|147237741|SUPERIORITY||Odds Ratio (OR)|17.94|||<|0.0001|TWO_SIDED|95.0|2.33|138.2|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Success at Week 8 Odds Ratio||138.20|2.33|<0.0001
73845320|NCT04211363|147237742|SUPERIORITY||Odds Ratio (OR)|29.36||||0.003|TWO_SIDED|95.0|2.99|288.36|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Clear at Week 8 Odds Ratio||288.36|2.99|0.003
73898541|NCT02880956|147328897|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73845321|NCT04211363|147237743|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1197|TWO_SIDED|95.0|0.98|3.19|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS Success at Week 2 Odds Ratio||3.19|0.98|0.1197
73845322|NCT04211363|147237743|SUPERIORITY||Odds Ratio (OR)|4.36|||<|0.0001|TWO_SIDED|95.0|2.31|8.26|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS Success at Week 4 Odds Ratio||8.26|2.31|<0.0001
73845323|NCT04211363|147237743|SUPERIORITY||Odds Ratio (OR)|7.84|||<|0.0001|TWO_SIDED|95.0|3.85|15.94|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS at Week 8 Odds Ratio||15.94|3.85|<0.0001
73845324|NCT04211363|147237744|SUPERIORITY||Mean Difference (Final Values)|-25.83|||<|0.0001|TWO_SIDED|95.0|-31.7|-20.0|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Comparison of change from baseline in PSD score at Week 4||-20.0|-31.7|<0.0001
73845325|NCT04211363|147237744|SUPERIORITY||Mean Difference (Final Values)|-30.9|||<|0.0001|TWO_SIDED|95.0|-37.2|-24.6|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Comparison of change from baseline in PSD score at Week 8||-24.6|-37.2|<0.0001
73845326|NCT03097289|147237745|NON_INFERIORITY|"The acceptance criterion for the recovery (%) of platelets is the demonstration of non-inferiority by the rejection of the Null Hypothesis (H0) defined by the following hypotheses: Null Hypothesis H0: μd ≤ 0 where μd=μT-0.66\*μC Alternate Hypothesis H1: μd \>~Let Xi = (XTi-0.66\*XCi) be a difference if recovery for patient i. The sample mean and standard deviations of these observed differences will be used to construct the lower limit of a 1-sided 97.5% confidence interval."|Mean Difference (Final Values)|8.18|||||ONE_SIDED|97.5|4.03||||||||||4.03|
73845327|NCT03097289|147237746|NON_INFERIORITY|"The acceptance criterion for the survival (days) of platelets is the demonstration of non inferiority by the rejection of the null hypothesis (H0) defined by the following hypotheses:~Null Hypothesis H0: μd ≤ 0 where μd = μT-0.58 × μC Alternate Hypothesis H1: μd \> 0"|Mean Difference (Final Values)|0.8|||||ONE_SIDED|97.5|0.39||||||||||0.39|
73845328|NCT01734902|147237754|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|86.97|STANDARD_ERROR_OF_MEAN|35.6|||TWO_SIDED|90.0|74.046|102.151|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.151|74.046|
73845329|NCT01734902|147237755|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|89.05|STANDARD_ERROR_OF_MEAN|31.2|||TWO_SIDED|90.0|77.26|102.62|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.62|77.26|
73845330|NCT01734902|147237756|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R [%]|90.03|STANDARD_ERROR_OF_MEAN|29.3|||TWO_SIDED|90.0|78.78|102.88|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.88|78.78|
73845331|NCT00060944|147237757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.734||||0.0302|TWO_SIDED|95.0|0.554|0.974|||Log Rank|||||0.974|0.554|0.0302
73845332|NCT00060944|147237760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.0418|TWO_SIDED|95.0|0.574|0.992|||Log Rank|||||0.992|0.574|0.0418
73845333|NCT00060944|147237761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.843||||0.192|TWO_SIDED|95.0|0.653|1.09|||Log Rank|||||1.090|0.653|0.1920
73845334|NCT04549454|147237773|SUPERIORITY||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.598||0.985|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.985
73845335|NCT04549454|147237774|SUPERIORITY||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.618||0.694|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.694
73845336|NCT04549454|147237775|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.327||0.889|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.889
73845337|NCT04549454|147237776|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.338||0.582|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.582
73845338|NCT04549454|147237777|SUPERIORITY||Mean Difference (Final Values)|-0.265|STANDARD_ERROR_OF_MEAN|0.414||0.523|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.523
73845339|NCT04549454|147237778|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.427||0.981|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.981
73845340|NCT04549454|147237779|SUPERIORITY||Median Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.327||0.889|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.889
73845341|NCT04549454|147237780|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.338||0.582|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.582
73845342|NCT00867035|147237781|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Rosenberg scores compared baseline to 1 hour by Mann-Whitney U test.||||<0.001
73845343|NCT00867035|147237781|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||mann whitney u to compare rosenberg score baseline to 1 hour||||<.001
73845344|NCT00867035|147237781|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours||||<0.001
73845345|NCT00867035|147237781|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours||||<0.001
73845346|NCT00867035|147237781|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 1 week||||<0.001
73845347|NCT00867035|147237781|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours||||<0.01
73845348|NCT00867035|147237781|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours||||<0.01
73845349|NCT00867035|147237781|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 1 week||||<0.05
73845350|NCT00867035|147237782|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 hour analyzed between groups.||||>0.05
73845351|NCT00867035|147237783|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
73845352|NCT00867035|147237784|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 4 hours analyzed between groups||||>0.05
73845353|NCT00867035|147237785|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
73845354|NCT00867035|147237786|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 1 hour analyzed between groups||||>0.05
73845355|NCT00867035|147237787|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test||||>0.05
73845356|NCT00867035|147237788|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 4 hours analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
73845357|NCT00867035|147237789|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrtations of MM in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test||||>0.05
73845358|NCT00867035|147237790|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Counts of colony forming units from swab of 1square centimeter area on tongue at 1 week cultured on anaerobe plates for 1 week analyzed between groups||||>0.05
73845359|NCT00867035|147237791|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Percentage of black colonies out of Total Viable Count cultured on anaerobe agar with lead acetate. Black colonies are those producing sulfides (H2S, MM)and creating black lead sulfide. Analyzed between groups. Groups compared at baseline and 1 week.||||>0.05
73845360|NCT03110562|147237796|SUPERIORITY||Hazard Ratio (HR)|0.702||||0.0075|TWO_SIDED|95.0|0.5279|0.9335||One Sided P-value|Stratified Log-rank Test|Stratified for prior PI therapies, number of prior of anti-MM regimens and R-ISS Stage at screening.|Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.|||0.9335|0.5279|0.0075
73845361|NCT03110562|147237797|SUPERIORITY||Odds Ratio (OR)|1.9626||||0.0012|TWO_SIDED|95.0|1.2641|3.0471||One Sided P-value|Cochran-Mantel-Haenszel|Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.||||3.0471|1.2641|0.0012
73845362|NCT03110562|147237798|SUPERIORITY||Odds Ratio (OR)|1.6594||||0.0082|TWO_SIDED|95.0|1.0993|2.5049||One Sided P-value|Cochran-Mantel-Haenszel|Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.||||2.5049|1.0993|0.0082
73959927|NCT00762619|147455251|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845363|NCT03110562|147237799|SUPERIORITY||Odds Ratio (OR)|0.5042||||0.0013|TWO_SIDED|95.0|0.3216|0.7906||One Sided P-value|Cochran-Mantel-Haenszel||Stratified by Prior PI therapies (Yes or No), Number of prior anti-MM regimens (1 or \>1), and R-ISS stage at study entry (R-ISS Stage III versus R-ISS Stage I or II).|||0.7906|0.3216|0.0013
73845364|NCT03110562|147237800|SUPERIORITY||Hazard Ratio (HR)|0.8764||||0.2152|TWO_SIDED|95.0|0.6313|1.2168||One Sided P-value|Stratified log-rank test|Stratified for prior PI therapies, number of prior anti-MM regimens and R-ISS Stage at screening.|Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.|||1.2168|0.6313|0.2152
73845365|NCT04066829|147237827|OTHER||Difference in Differences|-29.2|||||TWO_SIDED|95.0|-42.2|-11.8||||||Pre and post difference in the treatment group as compared to the control group. A log transformation was used.||-11.8|-42.2|
73845366|NCT01334918|147237854|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Predefined noninferiority criterion: If the lower boundary of the 95% CI was within 0.15 of 0.78, MDCT would be determined to be noninferior to SPECT.|Agreement rate|0.87|STANDARD_ERROR_OF_MEAN|0.051|||TWO_SIDED|95.0|0.77|0.97||||||Analysis of agreement rate based on participants with 0 -1 and ≥ 2 reversible defects according to SPECT. Agreement is defined as the proportion of participants who had the same status from SPECT and MDCT, averaged across those with 2 or more reversible defects and those without, where SPECT is the reference standard.||0.97|0.77|
73845367|NCT01334918|147237859|SUPERIORITY_OR_OTHER_LEGACY||Specificity|0.95|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.9|0.99||||||Analysis of specificity based on participants with no fixed defects according to SPECT. Specificity is defined as a proportion of true negatives that are correctly identified, using SPECT as the reference standard.||0.99|0.90|
73845368|NCT01334918|147237859|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|0.77|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|0.54|1.0||||||Analysis of sensitivity based on participants with ≥ 1 fixed defect according to SPECT. Sensitivity is the proportion of true positives that are correctly identified using SPECT as the reference standard.||1.00|0.54|
73845369|NCT00949533|147237873|SUPERIORITY_OR_OTHER|||||||0.825|||||||Pearson Chi-Square|||||||0.825
73845370|NCT00949533|147237874|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||> 0.05
73845371|NCT00949533|147237875|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Cough: statistical difference between 2 groups was based on chi-squared test.||||1.000
73845372|NCT00949533|147237875|SUPERIORITY_OR_OTHER|||||||0.284|||||||Chi-squared|||Rhinorrhea: statistical difference between 2 groups was based on chi-squared test.||||0.284
73845373|NCT00949533|147237875|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Sore throat: statistical difference between 2 groups was based on fisher-exact test.||||1.000
73845374|NCT00949533|147237875|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Shortness of breath: statistical difference between 2 groups was based on fisher-exact test.||||1.000
73845375|NCT00949533|147237875|SUPERIORITY_OR_OTHER|||||||0.487|||||||Fisher Exact|||Diarrhea: statistical difference between 2 groups was based on fisher-exact test.||||0.487
73845376|NCT00949533|147237875|SUPERIORITY_OR_OTHER|||||||0.593|||||||Fisher Exact|||Headache: statistical difference between 2 groups was based on fisher-exact test.||||0.593
73845377|NCT00949533|147237875|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Conjunctivitis: statistical difference between 2 groups was based on fisher-exact test.||||1.000
73845378|NCT00949533|147237875|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Vomiting: statistical difference between 2 groups was based on fisher-exact test.||||1.000
73845379|NCT00949533|147237875|SUPERIORITY_OR_OTHER|||||||0.106|||||||Fisher Exact|||Other: statistical difference between 2 groups was based on fisher-exact test.||||0.106
73845380|NCT01959529|147237877|NON_INFERIORITY|Non-inferiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was below 1.3 or equivalent if the p-value for the one-sided test of null hypothesis (H0): HR≥1.3 against the alternative hypothesis (Ha): HR\<1.3 was less than 2.5%.|Hazard Ratio (HR)|0.908|||<|0.001|TWO_SIDED|95.0|0.781|1.055||p value : Refers to one-sided test of HR \>= 1.3 (against Ha: HR\<1.3).|Regression, Cox|||The hazard ratio (HR) (IDeg vs IGlar) was based on Cox regression with investigational medicinal product as only factor for primary analysis.||1.055|0.781|<0.001
73845381|NCT01959529|147237878|SUPERIORITY||Rate ratio|0.601|||<|0.001|TWO_SIDED|95.0|0.476|0.759||p-value : Refers to one-sided test of RR \>= 1.0 (against Ha: RR\<1.0)|Negative binomial regression|The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS.||Superiority was considered confirmed if the upper limit of the two-sided 95% confidence interval for the rate ratio (RR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: RR ≥1.0 against Ha: RR \<1.0, was less than 2.5%||0.759|0.476|<0.001
73845382|NCT01959529|147237879|SUPERIORITY||Odds Ratio (OR)|0.729|||<|0.001|TWO_SIDED|95.0|0.6|0.866||p-value: Refers to one-sided test of OR \>= 1.0 (against Ha: OR\<1.0)|Regression, Logistic|The model was logistic regression with log-link function.The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS||Superiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the odds ratio (OR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: OR ≥1.0 against Ha: OR\<1.0, was less than 2.5%.||0.866|0.600|<0.001
73845383|NCT01440764|147237881|SUPERIORITY|||||||0.99||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. This p-value describes the a priori analysis of comparing the furosemide test result to the saline test result.|t-test, 2 sided|||||||0.99
73845384|NCT01440764|147237881|SUPERIORITY|||||||0.32||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. Thes p-value describes the a priori analysis of comparing the response to furosemide to the mean response to saline.|t-test, 2 sided|||||||0.32
73845385|NCT01440764|147237883|SUPERIORITY|||||||0.0006||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||.0006
73845386|NCT01440764|147237883|SUPERIORITY||||||=|1e-05||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||=.00001
73845387|NCT01440764|147237883|SUPERIORITY|||||||2e-07||||||a priori threshold for significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||.0000002
73898542|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.156||0.454|TWO_SIDED|95.0|-0.189|0.423||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.423|-0.189|0.454
73845388|NCT00854360|147237891|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.26||0.255|TWO_SIDED|95.0|-0.8|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.21|-0.80|0.255
73845389|NCT00854360|147237891|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.25||0.257|TWO_SIDED|95.0|-0.78|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.21|-0.78|0.257
73845390|NCT00854360|147237891|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.25||0.013|TWO_SIDED|95.0|-1.13|-0.13||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.13|-1.13|0.013
73845391|NCT00854360|147237892|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.25||0.278|TWO_SIDED|95.0|-0.77|0.22||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.22|-0.77|0.278
73845392|NCT00854360|147237892|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.385|TWO_SIDED|95.0|-0.7|0.27||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.27|-0.70|0.385
73845393|NCT00854360|147237892|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.016|TWO_SIDED|95.0|-1.09|-0.11||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated Measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.11|-1.09|0.016
73845394|NCT00854360|147237893|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.26||0.082|TWO_SIDED|95.0|-0.95|0.06||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.06|-0.95|0.082
73845395|NCT00854360|147237893|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.114|TWO_SIDED|95.0|-0.9|0.1||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.10|-0.90|0.114
73845396|NCT00854360|147237893|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.26||0.001|TWO_SIDED|95.0|-1.33|-0.33||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.33|-1.33|0.001
73845397|NCT00854360|147237894|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.747|TWO_SIDED|95.0|-0.52|0.37||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.37|-0.52|0.747
73845398|NCT00854360|147237894|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.605|TWO_SIDED|95.0|-0.53|0.31||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.31|-0.53|0.605
73845399|NCT00854360|147237894|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.23||0.083|TWO_SIDED|95.0|-0.84|0.05||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.05|-0.84|0.083
73898543|NCT02880956|147328897|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73845400|NCT00854360|147237895|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.989|TWO_SIDED|95.0|-0.45|0.46||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.46|-0.45|0.989
73845401|NCT00854360|147237895|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.23||0.808|TWO_SIDED|95.0|-0.39|0.5||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.50|-0.39|0.808
73845402|NCT00854360|147237895|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.23||0.195|TWO_SIDED|95.0|-0.74|0.15||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.15|-0.74|0.195
73845403|NCT00854360|147237896|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.31||0.903|TWO_SIDED|95.0|-0.64|0.57||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.57|-0.64|0.903
73845404|NCT00854360|147237896|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.31||0.952|TWO_SIDED|95.0|-0.58|0.62||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.62|-0.58|0.952
73845405|NCT00854360|147237896|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.187|TWO_SIDED|95.0|-0.99|0.19||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.19|-0.99|0.187
73845406|NCT01128569|147237901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||||TWO_SIDED|95.0|0.087|0.237||||||||0.237|0.087|
73845407|NCT01128569|147237901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||||TWO_SIDED|95.0|0.069|0.222||||||||0.222|0.069|
73845408|NCT01128569|147237901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|||||TWO_SIDED|95.0|-0.091|0.057||||||||0.057|-0.091|
73845409|NCT00859833|147237933|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for equivalence: SD for adenosine = 0.59, SD for regadenoson = 0.92, true difference between groups = 0.19. With n=28, DOF = 46. Power for equivalence (with alpha = 0.05) = 0.98585.|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.7||0.3617|TWO_SIDED|95.0|-0.6041|0.2241|||t-test, 2 sided|||Null hypothesis is that myocardial perfusion reserve (MPR) is not different when measured with adenosine or regadenoson in patients across a broad range of body sizes.||0.2241|-0.6041|0.3617
73845410|NCT02493764|147237934|NON_INFERIORITY|Non-inferiority was declared when the upper bound of the 2-sided 95% confidence interval (CI) for the difference in mortality (IMI/REL minus PIP/TAZ) was \< 10 percentage points.|Adjusted difference in ACM|-5.3|||<|0.001|TWO_SIDED|95.0|-11.9|1.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||1.2|-11.9|<0.001
73845411|NCT02493764|147237935|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 2-sided 95% CI for the difference in FCR (IMI/REL minus PIP/TAZ) was \> 12.5 percentage points.|Adjusted difference in FCR|5.0|||<|0.001|TWO_SIDED|95.0|-3.2|13.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in FCR||13.2|-3.2|<0.001
73845412|NCT02493764|147237936|OTHER|Difference in % with AE vs PIP/TAZ|Difference in % with AE|-1.7|||||TWO_SIDED|95.0|-7.7|4.3||||||||4.3|-7.7|
73845413|NCT02493764|147237937|OTHER|Difference in % discontinuing vs PIP/TAZ|Difference in % discontinuing|-2.5|||||TWO_SIDED|95.0|-7.1|1.8||||||||1.8|-7.1|
73845414|NCT02493764|147237938|OTHER||Adjusted difference in ACM|-3.5|||||TWO_SIDED|95.0|-10.9|3.6|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||3.6|-10.9|
73845415|NCT02493764|147237939|NON_INFERIORITY|Non-inferiority was declared when the upper bound of the 2-sided 95% CI for the difference in mortality (IMI/REL minus PIP/TAZ) was ≥ 10 percentage points.|Adjusted difference in ACM|-4.6|||||TWO_SIDED|95.0|-11.0|1.7|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||1.7|-11.0|
73845416|NCT02493764|147237940|OTHER|Adjusted difference in ACM|Adjusted difference in ACM|-3.1|||||TWO_SIDED|95.0|-10.2|3.8|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||3.8|-10.2|
73845417|NCT02493764|147237941|OTHER|Difference in FCR|Adjusted difference in FCR|-1.7|||||TWO_SIDED|95.0|-11.3|7.8|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.8|-11.3|
73845418|NCT02493764|147237942|OTHER|Difference in FCR|Adjusted difference in FCR|-2.2|||||TWO_SIDED|95.0|-9.8|5.5|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||5.5|-9.8|
73845419|NCT02493764|147237943|OTHER|Difference in favorable clinical response|Adjusted difference in FCR|6.6|||||TWO_SIDED|95.0|-4.6|18.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||18.4|-4.6|
73845420|NCT02493764|147237944|OTHER|Difference in FCR|Adjusted difference in FCR|-0.4|||||TWO_SIDED|95.0|-8.1|7.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.4|-8.1|
73845421|NCT02493764|147237945|OTHER|Difference in FCR|Adjusted difference in FCR|-3.4|||||TWO_SIDED|95.0|-14.3|7.5|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.5|-14.3|
73845422|NCT02493764|147237946|OTHER|Difference in FCR|Adjusted difference in FCR|-3.7|||||TWO_SIDED|95.0|-13.6|6.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||6.4|-13.6|
73845423|NCT02493764|147237947|OTHER|Difference in FCR|Adjusted difference in FCR|3.5|||||TWO_SIDED|95.0|-4.6|11.6|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||11.6|-4.6|
73845424|NCT02493764|147237948|OTHER|Difference in FCR|Adjusted difference in FCR|0.5|||||TWO_SIDED|95.0|-6.3|7.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.4|-6.3|
73845425|NCT02493764|147237949|OTHER|Difference in FCR|Adjusted difference in FCR|3.4|||||TWO_SIDED|95.0|-7.1|14.2|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||14.2|-7.1|
73845426|NCT02493764|147237950|OTHER|Difference in FCR|Adjusted difference in FCR|4.4|||||TWO_SIDED|95.0|-3.1|12.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||12.0|-3.1|
73845427|NCT02493764|147237951|OTHER|Difference in FCR|Adjusted difference in FCR|1.1|||||TWO_SIDED|95.0|-7.2|9.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||9.4|-7.2|
73845428|NCT02493764|147237952|OTHER|Difference in FMR|Adjusted difference in FMR|9.7|||||TWO_SIDED|95.0|1.6|17.9|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||17.9|1.6|
73845429|NCT02493764|147237953|OTHER|Difference in FMR|Adjusted difference in FMR|6.2|||||TWO_SIDED|95.0|-2.7|15.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||15.0|-2.7|
73845430|NCT02493764|147237954|OTHER|Difference in FMR|Adjusted difference in FMR|2.5|||||TWO_SIDED|95.0|-5.5|11.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||11.0|-5.5|
73845431|NCT02493764|147237955|OTHER|Difference in FMR|Adjusted difference in FMR|4.7|||||TWO_SIDED|95.0|-4.0|14.1|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||14.1|-4.0|
73845432|NCT01561976|147237972|OTHER||Ratio|108.94||||0.1413|TWO_SIDED|95.0|101.01|117.5|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||117.50|101.01|0.1413
73845433|NCT01561976|147237972|OTHER||Ratio|107.24||||0.1413|TWO_SIDED|95.0|99.37|115.73|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||115.73|99.37|0.1413
73845434|NCT01561976|147237973|OTHER||Ratio|116.5||||0.0171|TWO_SIDED|95.0|106.91|126.95|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||126.95|106.91|0.0171
73845435|NCT01561976|147237973|OTHER||Ratio|107.24||||0.0171|TWO_SIDED|95.0|98.35|116.94|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||116.94|98.35|0.0171
73845436|NCT01561976|147237974|OTHER||Ratio|116.87||||0.0169|TWO_SIDED|95.0|107.07|127.57|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||127.57|107.07|0.0169
73845437|NCT01561976|147237974|OTHER||Ratio|107.38||||0.0169|TWO_SIDED|95.0|98.3|117.29|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||117.29|98.30|0.0169
73845438|NCT04846231|147237990|SUPERIORITY||Mean Difference (Net)|35.22|||<|0.001|TWO_SIDED|95.0|29.13|41.32|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05. This belongs to the primary endpoint.||41.32|29.13|<0.001
73845439|NCT04846231|147237990|SUPERIORITY||Mean Difference (Net)|34.43|||<|0.001|TWO_SIDED|95.0|28.28|40.58|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||40.58|28.28|<0.001
73845440|NCT04846231|147237990|SUPERIORITY||Mean Difference (Net)|38.27|||<|0.001|TWO_SIDED|95.0|32.2|44.34|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||44.34|32.20|<0.001
73845441|NCT04846231|147237990|SUPERIORITY||Mean Difference (Net)|42.98|||<|0.001|TWO_SIDED|95.0|37.02|48.95|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||48.95|37.02|<0.001
73845442|NCT04846231|147237990|SUPERIORITY||Mean Difference (Final Values)|36.57|||<|0.001|TWO_SIDED|95.0|30.61|42.54|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||42.54|30.61|<0.001
73845443|NCT04846231|147237990|SUPERIORITY||Mean Difference (Net)|33.49|||<|0.001|TWO_SIDED|95.0|27.42|39.55|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||39.55|27.42|<0.001
73845444|NCT04846231|147237990|SUPERIORITY||Mean Difference (Net)|31.31|||<|0.001|TWO_SIDED|95.0|25.16|37.47|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||37.47|25.16|<0.001
73845445|NCT04846231|147237992|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
73845446|NCT01448616|147237994|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.86||||0.086|TWO_SIDED|95.0|0.71|1.01||ITT|Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.01|0.71|0.086
73845447|NCT01448616|147237994|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.94||||0.54|TWO_SIDED|95.0|0.75|1.16||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)|Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.16|0.75|0.54
73845448|NCT01448616|147237994|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.9||||0.47|TWO_SIDED|95.0|0.67|1.22|||Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.22|0.67|0.47
73845449|NCT01448616|147237995|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|-0.16||||0.18|TWO_SIDED|95.0|-0.4|0.07|||Linear Mixed Effects Model|||Intent to treat analysis||0.07|-0.40|0.18
73845450|NCT01448616|147237995|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|-0.5||||0.008|TWO_SIDED|95.0|-0.86|-0.13|||Linear Mixed Effects Model|||Intent to treat analysis||-0.13|-0.86|0.008
73845451|NCT01448616|147237995|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|0.16||||0.45|TWO_SIDED|95.0|-0.27|0.6|||Linear Mixed Effects Model|||Intent to treat analysis||0.60|-0.27|0.45
73845452|NCT01448616|147237996|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.9|TWO_SIDED|95.0|0.7|1.37|||Poisson GLME|||Intent to treat analysis||1.37|0.70|0.90
73845453|NCT01448616|147237996|SUPERIORITY||Risk Ratio (RR)|0.8||||0.25|TWO_SIDED|95.0|0.54|1.18|||Poisson GLM|||Intent to treat||1.18|0.54|0.25
73845454|NCT01448616|147237996|SUPERIORITY||Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.57|1.57|||Poisson GLM|||||1.57|0.57|0.82
73845455|NCT01448616|147237997|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.74||||0.01|TWO_SIDED|95.0|0.59|0.92|||Poisson GLME|||Intent to Treat||0.92|0.59|0.010
73845456|NCT01448616|147237997|SUPERIORITY||Risk Ratio (RR)|1.3||||0.09|TWO_SIDED|95.0|0.9|1.76|||Poisson GLM|||||1.76|0.9|0.09
73845457|NCT01448616|147237997|SUPERIORITY||Risk Ratio (RR)|0.9||||0.47|TWO_SIDED|95.0|0.67|1.22|||Poisson GLM|||Intent to treat analysis||1.22|0.67|0.47
73845458|NCT01959932|147238008|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|8.38|||<|0.001|TWO_SIDED|95.0|6.89|10.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||10.20|6.89|<0.001
73845459|NCT01959932|147238009|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|41.63|||<|0.001|TWO_SIDED|95.0|37.75|45.91||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||45.91|37.75|<0.001
73845460|NCT01959932|147238010|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|5.99|||<|0.001|TWO_SIDED|95.0|5.21|6.87||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||6.87|5.21|<0.001
73845461|NCT01959932|147238011|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.45|||<|0.001|TWO_SIDED|95.0|22.0|24.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||24.99|22.00|<0.001
73845462|NCT00758563|147238014|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
73845463|NCT00833521|147238019|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|91.1||||||90.0|86.3|96.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.1|86.3|
73845464|NCT00833521|147238020|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.0||||||90.0|91.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|91.0|
73845465|NCT00833521|147238021|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.8||||||90.0|90.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|90.7|
73845466|NCT01405196|147238047|SUPERIORITY||Odds Ratio (OR)|2.23||||0.076|TWO_SIDED|90.0|0.89|5.62||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the Odds ratio (ORs) as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.62|0.89|0.076
73845467|NCT01405196|147238047|SUPERIORITY||Odds Ratio (OR)|0.96||||0.528|TWO_SIDED|90.0|0.38|2.41||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.41|0.38|0.528
73845468|NCT01405196|147238048|SUPERIORITY||Odds Ratio (OR)|2.77|||||TWO_SIDED|90.0|0.62|12.4||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||12.40|0.62|
73845469|NCT01405196|147238048|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|90.0|0.31|7.71||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.71|0.31|
73845470|NCT01405196|147238048|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|90.0|0.4|2.67||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.67|0.40|
73845471|NCT01405196|147238048|SUPERIORITY||Odds Ratio (OR)|0.77|||||TWO_SIDED|90.0|0.29|2.05||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.05|0.29|
73845472|NCT01405196|147238048|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|90.0|0.35|2.24||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.24|0.35|
73845473|NCT01405196|147238048|SUPERIORITY||Odds Ratio (OR)|0.44|||||TWO_SIDED|90.0|0.16|1.16||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.16|0.16|
73845474|NCT01405196|147238048|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|90.0|0.64|4.09||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.09|0.64|
73845475|NCT01405196|147238048|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|90.0|0.27|1.77||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.77|0.27|
73845476|NCT01405196|147238048|SUPERIORITY||Odds Ratio (OR)|1.95|||||TWO_SIDED|90.0|0.78|4.84||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.84|0.78|
73845477|NCT01405196|147238048|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|90.0|0.38|2.32||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.32|0.38|
73845478|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|90.0|0.28|3.88||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.88|0.28|
73845479|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.19|3.01||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.01|0.19|
73845480|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|90.0|0.28|1.85||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.85|0.28|
73845481|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|90.0|0.32|2.02||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.02|0.32|
73845482|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.3|1.83||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.83|0.30|
73845483|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|0.45|||||TWO_SIDED|90.0|0.18|1.13||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.13|0.18|
74088235|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.17||0.0015|TWO_SIDED|95.0|-0.89|-0.21|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.89|0.0015
73845484|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|90.0|0.58|3.6||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.60|0.58|
73845485|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|0.74|||||TWO_SIDED|90.0|0.3|1.84||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.84|0.30|
73845486|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|1.78|||||TWO_SIDED|90.0|0.72|4.37||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.37|0.72|
73845487|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED|90.0|0.5|2.92||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.92|0.50|
73959928|NCT00762619|147455252|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845488|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|90.0|0.89|5.55||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.55|0.89|
73845489|NCT01405196|147238049|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|90.0|0.4|2.46||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.46|0.40|
73845490|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|90.0|0.53|3.35||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.35|0.53|
73845491|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|90.0|0.41|2.65||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.65|0.41|
73845492|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|90.0|0.33|1.96||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.96|0.33|
73845493|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|90.0|0.39|2.23||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.23|0.39|
73845494|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|90.0|0.42|2.45||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.45|0.42|
73845495|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|1.31|||||TWO_SIDED|90.0|0.55|3.1||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.10|0.55|
73845496|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|2.36|||||TWO_SIDED|90.0|0.95|5.88||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.88|0.95|
73845497|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|1.82|||||TWO_SIDED|90.0|0.74|4.46||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.46|0.74|
73845498|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|2.8|||||TWO_SIDED|90.0|1.1|7.12||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.12|1.10|
73845499|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|90.0|0.66|4.21||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.21|0.66|
74022475|NCT00393718|147597245|SUPERIORITY_OR_OTHER||Least Squares Mean|-19.97|||<|0.0001||95.0|-27.99|-11.94||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-11.94|-27.99|<0.0001
73845500|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|2.95|||||TWO_SIDED|90.0|1.18|7.41||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.41|1.18|
73845501|NCT01405196|147238050|SUPERIORITY||Odds Ratio (OR)|2.03|||||TWO_SIDED|90.0|0.82|5.06||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.06|0.82|
73845502|NCT01405196|147238051|SUPERIORITY||Odds Ratio (OR)|1.59||||0.205|TWO_SIDED|90.0|0.63|4.02||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||\>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.02|0.63|0.205
73845503|NCT01405196|147238051|SUPERIORITY||Odds Ratio (OR)|0.84||||0.625|TWO_SIDED|90.0|0.34|2.08||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||\>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.08|0.34|0.625
73845504|NCT01405196|147238051|SUPERIORITY||Odds Ratio (OR)|2.81||||0.198|TWO_SIDED|90.0|0.38|20.65||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||20.65|0.38|0.198
73845505|NCT01405196|147238051|SUPERIORITY||Odds Ratio (OR)|2.88||||0.192|TWO_SIDED|90.0|0.39|21.3||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||21.30|0.39|0.192
73845506|NCT01405196|147238063|SUPERIORITY||LS mean difference|-5.41|||||TWO_SIDED|90.0|-12.3|1.49||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||1.49|-12.30|
74088236|NCT02709486|147729986|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.07|-0.39|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.07|<.0001
73845507|NCT01405196|147238063|SUPERIORITY||LS Mean difference|-1.39|||||TWO_SIDED|90.0|-8.21|5.42||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||5.42|-8.21|
73845508|NCT01405196|147238063|SUPERIORITY||LS Mean difference|1.3|||||TWO_SIDED|90.0|-5.71|8.32||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||8.32|-5.71|
73845509|NCT01405196|147238063|SUPERIORITY||LS Mean difference|4.67|||||TWO_SIDED|90.0|-2.22|11.57||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||11.57|-2.22|
73845510|NCT01405196|147238063|SUPERIORITY||LS Mean difference|-3.98|||||TWO_SIDED|90.0|-11.04|3.07||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||3.07|-11.04|
73845511|NCT01405196|147238063|SUPERIORITY||LS Mean difference|-2.89|||||TWO_SIDED|90.0|-9.87|4.1||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.10|-9.87|
73845512|NCT01405196|147238063|SUPERIORITY||LS Mean difference|-6.21|||||TWO_SIDED|90.0|-13.37|0.94||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||0.94|-13.37|
73845513|NCT01405196|147238063|SUPERIORITY||LS Mean difference|1.98|||||TWO_SIDED|90.0|-5.17|9.13||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.13|-5.17|
73845514|NCT01405196|147238063|SUPERIORITY||LS Mean difference|2.07|||||TWO_SIDED|90.0|-4.7|8.84||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||8.84|-4.70|
73845515|NCT01405196|147238063|SUPERIORITY||LS Mean difference|-2.81|||||TWO_SIDED|90.0|-9.62|4.0||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.00|-9.62|
73845516|NCT01405196|147238063|SUPERIORITY||LS Mean difference|3.97|||||TWO_SIDED|90.0|-2.95|10.9||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||10.90|-2.95|
73845517|NCT01405196|147238063|SUPERIORITY||LS Mean difference|2.56|||||TWO_SIDED|90.0|-4.29|9.4||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.40|-4.29|
73845518|NCT01405196|147238063|SUPERIORITY||LS Mean difference|3.14|||||TWO_SIDED|90.0|-3.67|9.94||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.94|-3.67|
73845519|NCT01405196|147238063|SUPERIORITY||LS Mean difference|-4.94|||||TWO_SIDED|90.0|-11.91|2.03||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||2.03|-11.91|
73845520|NCT01405196|147238063|SUPERIORITY||LS Mean difference|-2.64|||||TWO_SIDED|90.0|-9.61|4.32||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.32|-9.61|
73845521|NCT01405196|147238063|SUPERIORITY||LS Mean difference|2.66|||||TWO_SIDED|90.0|-4.48|9.8||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.80|-4.48|
73845522|NCT01405196|147238064|SUPERIORITY||LS mean difference|3.63||||||90.0|-2.56|9.83||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||9.83|-2.56|
73845523|NCT01405196|147238064|SUPERIORITY||LS mean difference|-2.02||||||90.0|-8.21|4.18||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||4.18|-8.21|
73845524|NCT01405196|147238064|SUPERIORITY||LS mean difference|2.62|||||TWO_SIDED|90.0|-3.57|8.82||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||8.82|-3.57|
73845525|NCT01405196|147238064|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-4.51|7.88||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||7.88|-4.51|
73845526|NCT01405196|147238064|SUPERIORITY||LS mean difference|4.59|||||TWO_SIDED|90.0|-1.61|10.79||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||10.79|-1.61|
73845527|NCT01405196|147238064|SUPERIORITY||LS mean difference|3.95||||||90.0|-2.24|10.15||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||10.15|-2.24|
73845528|NCT01405196|147238064|SUPERIORITY||LS mean difference|1.92||||||90.0|-4.17|8.01||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||8.01|-4.17|
73845529|NCT01405196|147238064|SUPERIORITY||LS mean difference|-4.2||||||90.0|-10.25|1.85||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||1.85|-10.25|
73959929|NCT00762619|147455253|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845530|NCT01405196|147238064|SUPERIORITY||LS mean difference|1.5|||||TWO_SIDED|90.0|-4.56|7.55||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||7.55|-4.56|
73845531|NCT01405196|147238064|SUPERIORITY||LS mean difference|0.1|||||TWO_SIDED|90.0|-5.96|6.15||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||6.15|-5.96|
73845532|NCT01405196|147238064|SUPERIORITY||LS mean difference|-0.34|||||TWO_SIDED|90.0|-6.39|5.71||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||5.71|-6.39|
73845533|NCT01405196|147238064|SUPERIORITY||LS mean difference|-2.34|||||TWO_SIDED|90.0|-8.39|3.71||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||3.71|-8.39|
73845534|NCT01405196|147238066|SUPERIORITY||LS mean difference|0.53|||||TWO_SIDED|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.59|-2.53|
73845535|NCT01405196|147238066|SUPERIORITY||LS mean difference|-0.48|||||TWO_SIDED|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.58|-3.54|
73845536|NCT01405196|147238066|SUPERIORITY||LS mean difference|1.28|||||TWO_SIDED|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.34|-1.78|
73845537|NCT01405196|147238066|SUPERIORITY||LS mean difference|1.78|||||TWO_SIDED|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.84|-1.28|
73845538|NCT01405196|147238066|SUPERIORITY||LS mean difference|1.2|||||TWO_SIDED|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-1.86|
73845539|NCT01405196|147238066|SUPERIORITY||LS mean difference|0.09|||||TWO_SIDED|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.15|-2.98|
73845540|NCT01405196|147238066|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.03|-3.03|
73845541|NCT01405196|147238066|SUPERIORITY||LS mean difference|-0.09|||||TWO_SIDED|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.92|-3.09|
73845542|NCT01405196|147238066|SUPERIORITY||LS mean difference|-0.02|||||TWO_SIDED|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.99|-3.03|
73845543|NCT01405196|147238066|SUPERIORITY||LS mean difference|-0.16|||||TWO_SIDED|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.85|-3.17|
73845544|NCT01405196|147238066|SUPERIORITY||LS mean difference|-1.58|||||TWO_SIDED|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||1.43|-4.58|
73845545|NCT01405196|147238066|SUPERIORITY||LS mean difference|-0.71|||||TWO_SIDED|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.30|-3.72|
73845546|NCT01405196|147238066|SUPERIORITY||LS mean difference|2.67|||||TWO_SIDED|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.20|0.14|
73845547|NCT01405196|147238066|SUPERIORITY||LS mean difference|3.36|||||TWO_SIDED|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.89|0.84|
73845548|NCT01405196|147238066|SUPERIORITY||LS mean difference|3.23|||||TWO_SIDED|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.76|0.70|
73845549|NCT01405196|147238066|SUPERIORITY||LS mean difference|3.77|||||TWO_SIDED|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.30|1.24|
73845550|NCT01405196|147238066|SUPERIORITY||LS mean difference|3.1|||||TWO_SIDED|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.63|0.57|
73845551|NCT01405196|147238066|SUPERIORITY||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.56|0.50|
73845552|NCT01405196|147238066|SUPERIORITY||LS mean difference|1.96|||||TWO_SIDED|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.46|-0.53|
73845553|NCT01405196|147238066|SUPERIORITY||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.17|0.20|
73845554|NCT01405196|147238066|SUPERIORITY||LS mean difference|1.84|||||TWO_SIDED|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.32|-0.65|
73845555|NCT01405196|147238066|SUPERIORITY||LS mean difference|2.01|||||TWO_SIDED|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.50|-0.47|
73845556|NCT01405196|147238066|SUPERIORITY||LS mean difference|2.34|||||TWO_SIDED|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.82|-0.15|
73845557|NCT01405196|147238066|SUPERIORITY||LS mean difference|2.59|||||TWO_SIDED|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.08|0.11|
73845558|NCT01405196|147238067|SUPERIORITY||LS mean difference|0.47||||||90.0|-6.33|7.27||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||7.27|-6.33|
73845559|NCT01405196|147238067|SUPERIORITY||LS mean difference|3.92||||||90.0|-2.88|10.72||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.72|-2.88|
73845560|NCT01405196|147238067|SUPERIORITY||LS mean difference|3.55|||||TWO_SIDED|90.0|-3.25|10.36||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.36|-3.25|
73845561|NCT01405196|147238067|SUPERIORITY||LS mean difference|7.85|||||TWO_SIDED|90.0|1.05|14.66||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||14.66|1.05|
73845562|NCT01405196|147238067|SUPERIORITY||LS mean difference|7.12|||||TWO_SIDED|90.0|0.32|13.92||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||13.92|0.32|
73845563|NCT01405196|147238067|SUPERIORITY||LS mean difference|4.33|||||TWO_SIDED|90.0|-2.47|11.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||11.13|-2.47|
73845564|NCT01405196|147238067|SUPERIORITY||LS mean difference|1.33|||||TWO_SIDED|90.0|-5.4|8.05||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||8.05|-5.40|
73845565|NCT01405196|147238067|SUPERIORITY||LS mean difference|3.93|||||TWO_SIDED|90.0|-2.75|10.62||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.62|-2.75|
73845566|NCT01405196|147238067|SUPERIORITY||LS mean difference|-0.78|||||TWO_SIDED|90.0|-7.47|5.91||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.91|-7.47|
73845567|NCT01405196|147238067|SUPERIORITY||LS mean difference|3.67||||||90.0|-3.02|10.35||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.35|-3.02|
73845568|NCT01405196|147238067|SUPERIORITY||LS mean difference|2.99|||||TWO_SIDED|90.0|-3.7|9.68||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||9.68|-3.70|
73845569|NCT01405196|147238067|SUPERIORITY||LS mean difference|1.44|||||TWO_SIDED|90.0|-5.24|8.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||8.13|-5.24|
73845570|NCT01405196|147238068|SUPERIORITY||LS mean difference|0.53|||||TWO_SIDED|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.59|-2.53|
73845571|NCT01405196|147238068|SUPERIORITY||LS mean difference|-0.48|||||TWO_SIDED|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.58|-3.54|
73845572|NCT01405196|147238068|SUPERIORITY||LS mean difference|1.28|||||TWO_SIDED|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.34|-1.78|
73845573|NCT01405196|147238068|SUPERIORITY||LS mean difference|1.78|||||TWO_SIDED|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.84|-1.28|
73845574|NCT01405196|147238068|SUPERIORITY||LS mean difference|1.2|||||TWO_SIDED|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-1.86|
73845575|NCT01405196|147238068|SUPERIORITY||LS mean difference|0.09|||||TWO_SIDED|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.15|-2.98|
73845576|NCT01405196|147238068|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.03|-3.03|
73845577|NCT01405196|147238068|SUPERIORITY||LS mean difference|-0.09|||||TWO_SIDED|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.92|-3.09|
73845578|NCT01405196|147238068|SUPERIORITY||LS mean difference|-0.02|||||TWO_SIDED|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.99|-3.03|
73845579|NCT01405196|147238068|SUPERIORITY||LS mean difference|-0.16|||||TWO_SIDED|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.85|-3.17|
73845580|NCT01405196|147238068|SUPERIORITY||LS mean difference|-1.58|||||TWO_SIDED|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||1.43|-4.58|
73845581|NCT01405196|147238068|SUPERIORITY||LS mean difference|-0.71|||||TWO_SIDED|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.30|-3.72|
73845582|NCT01405196|147238068|SUPERIORITY||LS mean difference|2.67|||||TWO_SIDED|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.20|0.14|
73845583|NCT01405196|147238068|SUPERIORITY||LS mean difference|3.36|||||TWO_SIDED|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.89|0.84|
73845584|NCT01405196|147238068|SUPERIORITY||LS mean difference|3.23|||||TWO_SIDED|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.76|0.70|
73845585|NCT01405196|147238068|SUPERIORITY||LS mean difference|3.77|||||TWO_SIDED|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.30|1.24|
73845586|NCT01405196|147238068|SUPERIORITY||LS mean difference|3.1|||||TWO_SIDED|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.63|0.57|
73959930|NCT00762619|147455254|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845587|NCT01405196|147238068|SUPERIORITY||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.56|0.50|
73845588|NCT01405196|147238068|SUPERIORITY||LS mean difference|1.96|||||TWO_SIDED|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.46|-0.53|
73845589|NCT01405196|147238068|SUPERIORITY||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.17|0.20|
73845590|NCT01405196|147238068|SUPERIORITY||LS mean difference|1.84|||||TWO_SIDED|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.32|-0.65|
73845591|NCT01405196|147238068|SUPERIORITY||LS mean difference|2.01|||||TWO_SIDED|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.50|-0.47|
73845592|NCT01405196|147238068|SUPERIORITY||LS mean difference|2.34|||||TWO_SIDED|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.82|-0.15|
73845593|NCT01405196|147238068|SUPERIORITY||LS mean difference|2.59|||||TWO_SIDED|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.08|0.11|
73845594|NCT01405196|147238070|SUPERIORITY||LS mean difference|2.08|||||TWO_SIDED|90.0|-1.26|5.42||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the Least Square (LS) mean difference from that model.||5.42|-1.26|
73845595|NCT01405196|147238070|SUPERIORITY||LS mean difference|1.95|||||TWO_SIDED|90.0|-1.38|5.29||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.29|-1.38|
73845596|NCT01405196|147238070|SUPERIORITY||LS mean difference|2.81|||||TWO_SIDED|90.0|-0.53|6.15||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.15|-0.53|
73845597|NCT01405196|147238070|SUPERIORITY||LS mean difference|3.88|||||TWO_SIDED|90.0|0.54|7.22||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||7.22|0.54|
73845598|NCT01405196|147238070|SUPERIORITY||LS mean difference|1.95|||||TWO_SIDED|90.0|-1.39|5.29||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.29|-1.39|
73845599|NCT01405196|147238070|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-1.65|5.03||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.03|-1.65|
73898544|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_DEVIATION|0.16||0.644|TWO_SIDED|95.0|-0.24|0.388||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.388|-0.240|0.644
73898545|NCT02880956|147328897|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|1.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73959931|NCT00762619|147455255|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845600|NCT01405196|147238070|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-1.61|4.99||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.99|-1.61|
73845601|NCT01405196|147238070|SUPERIORITY||LS mean difference|0.97|||||TWO_SIDED|90.0|-2.31|4.26||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-2.31|
73845602|NCT01405196|147238070|SUPERIORITY||LS mean difference|1.33|||||TWO_SIDED|90.0|-1.96|4.61||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.61|-1.96|
73845603|NCT01405196|147238070|SUPERIORITY||LS mean difference|3.6|||||TWO_SIDED|90.0|0.32|6.89||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.89|0.32|
73845604|NCT01405196|147238070|SUPERIORITY||LS mean difference|0.91|||||TWO_SIDED|90.0|-2.38|4.19||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.19|-2.38|
73845605|NCT01405196|147238070|SUPERIORITY||LS mean difference|0.6|||||TWO_SIDED|90.0|-2.68|3.88||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.88|-2.68|
73845606|NCT01729039|147238074|SUPERIORITY|||||||0.356||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA|||||||.356
73845607|NCT01729039|147238074|SUPERIORITY|||||||0.84||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.840
73845608|NCT01729039|147238075|SUPERIORITY|||||||0.17||||||Main effect of Time (baseline to post-PT) Alpha=.05|ANOVA|||||||.170
73845609|NCT01729039|147238075|SUPERIORITY|||||||0.297||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.297
73845610|NCT01729039|147238076|SUPERIORITY||||||<|0.001|||||||ANOVA|Main effect of Time (baseline to post-PT) alpha = .05||||||<.001
73845611|NCT01729039|147238076|SUPERIORITY|||||||0.817||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.817
74022476|NCT00393718|147597246|SUPERIORITY_OR_OTHER||Least Squares Mean|-13.03||||||95.0|-21.46|-4.6|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-4.60|-21.46|
73845612|NCT01729039|147238077|SUPERIORITY|||||||0.005||||||Main effect of Time (baseline to post-PT) alpha = .05|ANOVA|||||||.005
73845613|NCT01729039|147238077|SUPERIORITY|||||||0.172||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.172
73845614|NCT01729039|147238078|SUPERIORITY|||||||0.009||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA|||||||.009
73845615|NCT01729039|147238078|SUPERIORITY|||||||0.146||||||Interaction of Time by Grou (GS vs. CON) alpha = .05|ANOVA|||||||.146
73845616|NCT00829998|147238092|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|97.4||||||90.0|89.4|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|89.4|
73845617|NCT00829998|147238093|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|97.1|
73845618|NCT00829998|147238094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|97.1|
73845619|NCT00834197|147238095|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.59||||||90.0|95.76|105.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105.65|95.76|
73845620|NCT00834197|147238096|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.17||||||90.0|94.82|101.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.65|94.82|
73845621|NCT00834197|147238097|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.25||||||90.0|95.22|101.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.39|95.22|
73845622|NCT05788991|147238098|NON_INFERIORITY|Difference of proportions between groups (with 95% CI) and a non inferiority margin of 15 percentage points, assuming a 1-sided α = .025 and 80% power|Farrington-Manning test|-0.5|||<|0.025|ONE_SIDED|95.0|-10.8|||1 sided alpha|Farrington-Manning test|||The outcome measure of the primary objective was a noninferiority margin of 15 percentage points in the absolute difference in clinical cure rates between dequalinium chloride and metronidazole 7 to 11 days after start of treatment.|||-10.8|<.025
73845623|NCT05270863|147238105|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<.001
73845624|NCT04464473|147238106|SUPERIORITY|||||||0.5736|||||||ANOVA|The main effect of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of MFG efferent connectivity||||||0.5736
73845625|NCT04464473|147238106|SUPERIORITY|||||||0.304|||||||ANOVA|Interaction of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) and subsystem (Temporal, Contextual Control) on the magnitude of MFG efferent connectivity||||||0.304
73845626|NCT04464473|147238106|SUPERIORITY|||||||0.0545|||||||ANOVA|The main effect of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of FPl efferent connectivity||||||0.0545
73845627|NCT04464473|147238106|SUPERIORITY|||||||0.1134|||||||ANOVA|Interaction of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) and Subsystem on the magnitude of FPl efferent connectivity||||||0.1134
73845628|NCT04464473|147238106|SUPERIORITY|||||||0.4326|||||||ANOVA|The main effect of intervention (FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of MFG efferent connectivity||||||0.4326
73845629|NCT04464473|147238106|SUPERIORITY|||||||0.2546|||||||ANOVA|The interaction of intervention (FPl-TMS, MFG-TMS, S1-TMS) and subsystem (Temporal, Contextual Control) on the magnitude of MFG efferent connectivity||||||0.2546
73845630|NCT04464473|147238106|SUPERIORITY|||||||0.0645|||||||ANOVA|The main effect of intervention (FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of FPl efferent connectivity||||||0.0645
73845631|NCT04464473|147238106|SUPERIORITY|||||||0.2033|||||||ANOVA|Interaction of intervention (FPl-TMS, MFG-TMS, S1-TMS) and Subsystem on the magnitude of FPl efferent connectivity||||||0.2033
73845632|NCT04464473|147238107|SUPERIORITY|||||||0.8152|||||||ANOVA|Main effect of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) on overall BOLD actviation.||||||0.8152
73845633|NCT04464473|147238107|SUPERIORITY|||||||0.0085|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and subsystem (temporal, contextual, sensorimotor control) on overall BOLD activation.||||||0.0085
73845634|NCT04464473|147238107|SUPERIORITY|||||||0.1551|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on BOLD activation||||||0.1551
73845635|NCT04464473|147238107|SUPERIORITY|||||||0.6431|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on BOLD activation||||||0.6431
73845636|NCT04464473|147238107|SUPERIORITY|||||||0.2447|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on BOLD activation||||||0.2447
73845637|NCT04464473|147238107|SUPERIORITY|||||||0.0002|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.0002
73845638|NCT04464473|147238107|SUPERIORITY|||||||0.1339|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), contextual control, and subsystem on BOLD activation||||||0.1339
73845639|NCT04464473|147238107|SUPERIORITY|||||||0.1315|||||||ANOVA|Interaction of visit, temporal control, contextual control, and subsystem on BOLD activation||||||0.1315
73845640|NCT04464473|147238107|SUPERIORITY|||||||0.6836|||||||ANOVA|The main effect of intervention arm (FPl-TMS, MFG-TMS, S1-TMS) on overall BOLD activation.||||||0.6836
73845641|NCT04464473|147238107|SUPERIORITY|||||||0.2146|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and subsystem (temporal, contextual, sensorimotor control) on overall BOLD activation.||||||0.2146
73845642|NCT04464473|147238107|SUPERIORITY|||||||0.1541|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on BOLD activation||||||0.1541
73845643|NCT04464473|147238107|SUPERIORITY|||||||0.6657|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on BOLD activation||||||0.6657
73845644|NCT04464473|147238107|SUPERIORITY|||||||0.5619|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on BOLD activation||||||0.5619
73845645|NCT04464473|147238107|SUPERIORITY|||||||0.5148|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.5148
73845646|NCT04464473|147238107|SUPERIORITY|||||||0.5428|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), contextual control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.5428
73845647|NCT04464473|147238107|SUPERIORITY|||||||0.1249|||||||ANOVA|Interaction of intervention, temporal control, contextual control, and subsystem on BOLD activation||||||0.1249
73845648|NCT04464473|147238108|SUPERIORITY|||||||0.9504|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on error rate||||||0.9504
73845649|NCT04464473|147238108|SUPERIORITY|||||||0.7318|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control on error rate||||||0.7318
73845650|NCT04464473|147238108|SUPERIORITY|||||||0.8424|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on error rate||||||0.8424
73845651|NCT04464473|147238108|SUPERIORITY|||||||0.7652|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control on error rate||||||0.7652
73845652|NCT04464473|147238109|SUPERIORITY|||||||0.0266|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on error rate||||||0.0266
73845653|NCT04464473|147238109|SUPERIORITY|||||||0.2386|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return) and contextual control on error rate||||||0.2386
73845654|NCT04464473|147238109|SUPERIORITY|||||||0.4211|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on error rate||||||0.4211
73845655|NCT04464473|147238109|SUPERIORITY|||||||0.7503|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return) and contextual control on error rate||||||0.7503
73845656|NCT04464473|147238110|SUPERIORITY|||||||0.0091|||||||ANOVA|Interaction of Visit (Baseline, MFG-cTBS, FPl-cTBS, S1), Temporal Control, and Contextual Control on error rate||||||0.0091
73845657|NCT04464473|147238110|SUPERIORITY|||||||0.0045|||||||ANOVA|Interaction of Visit (Baseline, MFG-cTBS, FPl-cTBS, S1), phase (sub-task, return), Temporal Control, and Contextual Control on error rate||||||0.0045
73845658|NCT04464473|147238110|SUPERIORITY|||||||0.1082|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1), Temporal Control, and Contextual Control on error rate||||||0.1082
73845659|NCT04464473|147238110|SUPERIORITY|||||||0.0659|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1), phase (sub-task, return), Temporal Control, and Contextual Control on error rate||||||0.0659
73845660|NCT04464473|147238111|SUPERIORITY|||||||0.0211|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control in reaction time||||||0.0211
73845661|NCT04464473|147238111|SUPERIORITY|||||||0.4964|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control in reaction time||||||0.4964
73845662|NCT04464473|147238111|SUPERIORITY|||||||0.3129|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control in reaction time||||||0.3129
73845663|NCT04464473|147238111|SUPERIORITY|||||||0.5439|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control in reaction time||||||0.5439
73845664|NCT04464473|147238112|SUPERIORITY|||||||0.0344|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control in reaction time||||||0.0344
73845665|NCT04464473|147238112|SUPERIORITY|||||||0.5113|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and contextual control in reaction time||||||0.5113
73845666|NCT04464473|147238112|SUPERIORITY|||||||0.0301|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control in reaction time||||||0.0301
73845667|NCT04464473|147238112|SUPERIORITY|||||||0.6931|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and contextual control in reaction time||||||0.6931
73845668|NCT04464473|147238113|SUPERIORITY|||||||0.0189|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on reaction time||||||0.0189
73845669|NCT04464473|147238113|SUPERIORITY|||||||0.0763|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), temporal control, and contextual control on reaction time||||||0.0763
73845670|NCT04464473|147238113|SUPERIORITY|||||||0.9701|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on reaction time||||||0.9701
73845671|NCT04464473|147238113|SUPERIORITY|||||||0.3826|||||||ANOVA|Interaction of intervention(MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), temporal control, and contextual control on reaction time||||||0.3826
73845672|NCT01585025|147238124|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.007
73845673|NCT01585025|147238124|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.11
73845674|NCT01585025|147238124|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.12
73845675|NCT01585025|147238125|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.72
73845676|NCT01585025|147238125|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.51
73845677|NCT01585025|147238125|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.13
73845678|NCT01585025|147238126|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.03
73845679|NCT01585025|147238126|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.11
73845680|NCT01585025|147238126|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.02
73845681|NCT01585025|147238127|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.02
73845682|NCT01585025|147238127|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.04
73845683|NCT01585025|147238127|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.02
73845684|NCT01585025|147238128|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.03
73845685|NCT01585025|147238128|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.17
73845686|NCT01585025|147238128|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.31
73845687|NCT01585025|147238129|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.05
73845688|NCT01585025|147238129|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.04
73845689|NCT01585025|147238129|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.74
73845690|NCT01585025|147238130|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.005
73845691|NCT01585025|147238130|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.03
73845692|NCT01585025|147238130|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.61
73845693|NCT01246960|147238139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.886|TWO_SIDED|95.0|0.69|1.37|||Stratified Log Rank|||||1.37|0.69|0.886
73845694|NCT01246960|147238140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.712|TWO_SIDED|95.0|0.73|1.58|||Stratified Log Rank|||||1.58|0.73|0.712
73845695|NCT01246960|147238143|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.516|TWO_SIDED|95.0|0.59|1.3|||Stratified Log Rank|||||1.30|0.59|0.516
73845696|NCT03376516|147238200|OTHER|||||||0.9593||||||P-Value for patients aged 1-\<6 years (N=5)|ANOVA|||||||0.9593
73845697|NCT03376516|147238200|OTHER|||||||0.3752||||||P-Value for patients aged 6-\<12 years (N=5)|ANOVA|||||||0.3752
73845698|NCT03376516|147238200|OTHER|||||||0.8273||||||P-Value for total PK population (N=10)|ANOVA|||||||0.8273
73845699|NCT03376516|147238201|OTHER|P-Value for patients aged 1-\<6 years (N=5)||||||0.8536|||||||ANOVA|||||||0.8536
73845700|NCT03376516|147238201|OTHER|||||||0.9791||||||P-Value for patients aged 6-\<12 years (N=5)|ANOVA|||||||0.9791
73845701|NCT03376516|147238201|OTHER|||||||0.9791||||||P-Value for total PK population (N=10)|ANOVA|||||||0.9791
73845702|NCT03376516|147238203|OTHER||Pearson-Copper|0.0|||||TWO_SIDED|95.0|0.0|30.85||||||||30.85|0|
73898546|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|0.09|STANDARD_ERROR_OF_MEAN|0.232||0.685|TWO_SIDED|95.0|-0.363|0.551||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.551|-0.363|0.685
73845703|NCT00582907|147238209|SUPERIORITY_OR_OTHER||Risk Ratio, log|-1.7|STANDARD_DEVIATION|0.78||0.027|TWO_SIDED|95.0|-3.4|-0.1|||Signed rank|||Based upon FMF colchicine controlled studies showing an \~80% decrease in attacks, we estimated, based on baseline attacks every 4 weeks, there would be a difference of 0.5 attacks per month between rilonacept and placebo. With a two-sided 5% significance level and power of 80% we aimed for 14 evaluable participants who completed at least 2 treatment courses. The null hypothesis is that there would be no significant differences in the number of attacks between use of rilonacept and placebo.||-0.1|-3.4|0.027
73845704|NCT00582907|147238209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59|STANDARD_DEVIATION|0.12||||95.0|0.39|0.85|||Bayesian modeling||Attacks while receiving rilonacept is the numerator and attacks while receiving placebo is the denominator. In Bayesian statistics credible interval equals confidence interval.|This analysis was done by Bayesian Statistics using a non-informative (neutral) prior (log normal distribution mean 9 \[SD 10\]). The null hypothesis was that the rilonacept/placebo FMF odds ratio of attacks was 1.||0.85|0.39|
73845705|NCT00582907|147238210|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|STANDARD_DEVIATION|1.26||0.047|TWO_SIDED|95.0|-4.0|0.0|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of injection site reactions. No power calculations for this outcome.||0|-4|0.047
73845706|NCT00582907|147238210|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.13|TWO_SIDED|95.0|-0.56|0.17|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of infections. No power calculations for this outcome.||0.17|-0.56|0.13
73845707|NCT00582907|147238211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|0.5||0.32||95.0|-2.4|0.5|||Signed rank|||Null hypothesis: There were no significant differences in the length of attacks during rilonacept vs. placebo treatment courses. Since this was a secondary outcome there were no power calculations performed.||0.5|-2.4|0.32
73845708|NCT00582907|147238212|SUPERIORITY_OR_OTHER||Differences in percent of courses|29.0||||0.004||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses without attacks between rilonacept and placebo. As a secondary measure there were no power calculations.||||0.004
73845709|NCT00582907|147238213|SUPERIORITY_OR_OTHER||Difference in percent of courses|40.0||||0.006||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses attaining at least a 50% decrease in attacks when compared to baseline between rilonacept and placebo courses.Since this was a secondary measure there were no power calculations.||||0.006
73845710|NCT00582907|147238214|SUPERIORITY_OR_OTHER||Log Rank|0.009||||0.009||95.0|||||Kaplan-Meier survival analysis|||Null hypothesis: There were no significant differences between rilonacept and placebo in the number of days from the start of the treatment course until the development of the a second attack.||||0.009
73845711|NCT00582907|147238215|SUPERIORITY_OR_OTHER||Median Difference (Net)|6.5||||0.156|TWO_SIDED|95.0|-0.5|12.5|||Signed Rank|||Null hypothesis: There are no significant differences in the erythrocyte sedimentation rate between rilonacept and placebo. As a secondary measure there were no power calculations.||12.5|-0.5|0.156
73845712|NCT00582907|147238216|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.04||||0.22|TWO_SIDED|95.0|-0.03|0.29|||Signed Rank|||Null hypothesis: There are no differences in the C-reactive protein levels between the treatment courses. Since this was a secondary outcome measure no power calculations were performed.||0.29|-0.03|0.22
73845713|NCT00582907|147238217|SUPERIORITY_OR_OTHER||Median Difference (Net)|29.4||||0.078|TWO_SIDED|95.0|0.4|78.1|||Signed Rank|||Null hypothesis: There were no differences between the platelet count between the rilonacept and placebo courses. Since this was a secondary outcome no power calculations were performed.||78.1|0.4|0.078
73845714|NCT00582907|147238218|SUPERIORITY_OR_OTHER||Median Difference (Net)|108.0||||0.063|TWO_SIDED|95.0|6.5|139.5|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the fibrinogen level. Since this was a secondary outcome no power calculations were performed.||139.5|6.5|0.063
73845715|NCT00582907|147238219|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5|TWO_SIDED|95.0|-4.0|0.0|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the serum amyloid A levels. Since this was a secondary outcome no power calculations were performed.||0|-4|0.50
73845716|NCT00582907|147238220|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.5||||0.021|TWO_SIDED|95.0|-11.1|-2.3|||Signed rank|||Null hypothesis: There are no significant differences in the physical health-related quality of life between rilonacept and placebo. As a secondary measure there were no power calculations.||-2.3|-11.1|0.021
73845717|NCT00582907|147238220|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.2||||0.42|TWO_SIDED|95.0|-6.8|3.9|||Signed Rank|||||3.9|-6.8|0.42
73845718|NCT00582907|147238221|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.5||||0.136|TWO_SIDED|95.0|-2.3|9.8|||Signed rank|||Null hypothesis: There are no significant differences in the FMF Armenian Evaluation (severity) Score between rilonacept and placebo. As a secondary measure there were no power calculations.||9.8|-2.3|0.136
73845719|NCT00582907|147238222|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.0||||0.089|TWO_SIDED|95.0|-15.0|-1.0|||Signed rank|||Null hypothesis: There are no significant differences in the proportion of time participants were treated with rilonacept and placebo. As a secondary measure there were no power calculations.||-1|-15|0.089
73845720|NCT00370292|147238223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
73845721|NCT00370292|147238223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
73845722|NCT00370292|147238223|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.030
73845723|NCT00370292|147238223|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.166
73845724|NCT00370292|147238223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
73845725|NCT00370292|147238223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
73845726|NCT00370292|147238225|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
73845727|NCT00370292|147238225|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
73845728|NCT00370292|147238225|SUPERIORITY_OR_OTHER|||||||0.333||95.0||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.333
73845729|NCT00370292|147238225|SUPERIORITY_OR_OTHER|||||||0.849||95.0||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.849
73845730|NCT00370292|147238225|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
73845731|NCT00370292|147238225|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
73845732|NCT03545672|147238227|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.001
73845733|NCT03545672|147238228|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73845734|NCT00508521|147238235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.75|STANDARD_ERROR_OF_MEAN|0.47871||0.0001|TWO_SIDED|95.0|-22.27348|-19.22652|||t-test, 2 sided|||This was a feasibility study. Pre and post treatment analysis was performed for the study participants.||-19.22652|-22.27348|.0001
73845735|NCT04102007|147238278|OTHER|There is no statistical test for this study|Proportion of sPGA 0/1 @ WK 16|57.4|||||TWO_SIDED|95.0|51.1|63.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||63.4|51.1|
73845736|NCT04102007|147238279|OTHER|There is no statistical test for this study|Proportion of sPGA 0 @ WK 16|20.5|||||TWO_SIDED|95.0|15.4|26.0|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||26.0|15.4|
73845737|NCT04102007|147238280|OTHER|There is no statistical test for this study|Proportion of DLQI 0 or 1 @ WK 16|40.2|||||TWO_SIDED|95.0|34.2|46.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||46.4|34.2|
73845738|NCT04102007|147238281|OTHER|There is no statistical test for this study|Proportion of PSS 0 @ WK 16|20.9|||||TWO_SIDED|95.0|16.3|26.4|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||26.4|16.3|
73845739|NCT04102007|147238282|OTHER|There is no statistical test for this study|Proportion of sPGA 0/1 @ WK 52|62.3|||||TWO_SIDED|95.0|56.0|68.1|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||68.1|56.0|
73845740|NCT04102007|147238283|OTHER|There is no statistical test for this study|Proportion of sPGA 0 @ WK 52|27.1|||||TWO_SIDED|95.0|21.9|33.0|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||33.0|21.9|
73845741|NCT04102007|147238284|OTHER|There is no statistical test for this study|Proportion of DLQI 0 or 1 @ WK 52|47.2|||||TWO_SIDED|95.0|41.0|53.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||53.4|41.0|
73845742|NCT04102007|147238285|OTHER|There is no statistical test for this study|Proportion of PSS 0 @ WK 52|27.5|||||TWO_SIDED|95.0|22.3|33.4|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||33.4|22.3|
73845743|NCT01453166|147238288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.0|STANDARD_DEVIATION|19.0|<|0.05||95.0|100.0|140.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||140|100|<0.05
73845744|NCT01453166|147238289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.0|STANDARD_DEVIATION|15.0||0.05||95.0|66.0|95.0|||ANOVA|||||95|66|0.05
74088237|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.96|-0.38|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.38|-0.96|<.0001
73845745|NCT01453166|147238290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|170.0|STANDARD_DEVIATION|39.0||0.05||95.0|140.0|220.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||220|140|0.05
73845746|NCT01453166|147238291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|STANDARD_DEVIATION|12.0||0.05||95.0|88.0|112.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||112|88|0.05
73845747|NCT01453166|147238292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|STANDARD_DEVIATION|30.0||0.05||95.0|77.0|137.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||137|77|0.05
73845748|NCT01155050|147238309|SUPERIORITY|||||||0.296|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.296
73845749|NCT01155050|147238310|SUPERIORITY|||||||0.787|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.787
73845750|NCT01155050|147238311|SUPERIORITY|||||||0.34|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.340
73845751|NCT01155050|147238312|SUPERIORITY|||||||0.502|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.502
73959932|NCT00762619|147455256|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959933|NCT00762619|147455257|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845752|NCT01155050|147238313|SUPERIORITY|||||||0.86|||||||ANOVA|||The null hypothesis is that the outcome does not differ across the four groups.||||.860
73845753|NCT01155050|147238314|SUPERIORITY|||||||0.634|||||||ANOVA|||The null hypothesis is that the outcome does not differ across the four groups.||||.634
73845754|NCT01155050|147238315|SUPERIORITY|||||||0.879|||||||ANOVA|||The null hypothesis is that there is no difference in the outcome across the four treatment groups.||||.879
73959934|NCT00762619|147455258|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959935|NCT00762619|147455259|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959936|NCT00762619|147455260|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845755|NCT00652834|147238317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.05|TWO_SIDED|95.0||||The p value is only for GSRS score comparison only.|t-test, 2 sided||The GSRS range is 1-7|"The results of the initial SBCE exams were evaluated by a visually challenged GI specialist who gave us a descriptive report. By the end of the study, we submitted the final reports to the same specialist and asked his impression on the significant changes observed in patients' exams for each GI segment (stomach and small bowel).~There were no comparison groups. Each patient is their own control. Given that this is a pilot study there is no power calculation."||||0.05
73845756|NCT00320606|147238318|OTHER||95% confidence interval using an exact b|0.6|||||TWO_SIDED|95.0|0.4|0.8|||||Proportion Success|The proportion of participants in whom immunosuppression withdrawal was attempted who are successfully withdrawn from immunosuppression are descriptively summarized with 95% confidence intervals using an exact binomial method||0.8|0.4|
73845757|NCT00320606|147238319|OTHER||Binomial Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.1684|||||95% Confidence Interval Exact Binomial|The proportion of participants in whom immunosuppression (IS) withdrawal was attempted who are successfully withdrawn from immunosuppression and experience death or graft loss are descriptively summarized with 95% confidence intervals using an exact binomial method.||0.1684|0.0|
73845758|NCT00806585|147238329|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.1||||0.253|TWO_SIDED|95.0|-3.1|0.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.8|-3.1|0.253
73845759|NCT00806585|147238329|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.1||||0.919|TWO_SIDED|95.0|-2.1|1.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.9|-2.1|0.919
73845760|NCT00806585|147238329|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.2||||0.829|TWO_SIDED|95.0|-2.2|1.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.8|-2.2|0.829
73845761|NCT00806585|147238329|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.1||||0.074|TWO_SIDED|95.0|-4.5|0.2|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.2|-4.5|0.074
73845762|NCT00806585|147238329|SUPERIORITY_OR_OTHER||Difference in least squares means|1.0||||0.393|TWO_SIDED|95.0|-1.3|3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||3.3|-1.3|0.393
73845763|NCT00806585|147238329|SUPERIORITY_OR_OTHER||Difference in least squares means|2.0||||0.088|TWO_SIDED|95.0|-0.3|4.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||4.4|-0.3|0.088
73898547|NCT02880956|147328897|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
74088238|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.0139|TWO_SIDED|95.0|-0.67|-0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.67|0.0139
73845764|NCT00806585|147238329|SUPERIORITY_OR_OTHER||Difference in least squares means|1.9||||0.108|TWO_SIDED|95.0|-0.4|4.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||4.3|-0.4|0.108
73845765|NCT00806585|147238330|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0.543|TWO_SIDED|95.0|-4.0|2.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||2.1|-4.0|0.543
73845766|NCT00806585|147238330|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.8||||0.246|TWO_SIDED|95.0|-4.9|1.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.3|-4.9|0.246
73845767|NCT00806585|147238330|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.4||||0.821|TWO_SIDED|95.0|-3.5|2.7|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||2.7|-3.5|0.821
73845768|NCT00806585|147238330|SUPERIORITY_OR_OTHER||Difference in least squares means|-7.0|||<|0.001|TWO_SIDED|95.0|-10.7|-3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-3.3|-10.7|<0.001
73845769|NCT00806585|147238330|SUPERIORITY_OR_OTHER||Difference in least squares means|6.1||||0.001|TWO_SIDED|95.0|2.4|9.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||9.8|2.4|0.001
73845770|NCT00806585|147238330|SUPERIORITY_OR_OTHER||Difference in least squares means|5.2||||0.006|TWO_SIDED|95.0|1.5|8.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||8.9|1.5|0.006
73898548|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|0.28|STANDARD_ERROR_OF_MEAN|0.228||0.219|TWO_SIDED|95.0|-0.168|0.73||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.730|-0.168|0.219
73898549|NCT02880956|147328897|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|1.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
74088239|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.13|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.13|<.0001
73959937|NCT00762619|147455261|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959938|NCT00762619|147455262|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845771|NCT00806585|147238330|SUPERIORITY_OR_OTHER||Difference in least squares means|6.7|||<|0.001|TWO_SIDED|95.0|3.0|10.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||10.4|3.0|<0.001
73845772|NCT00806585|147238331|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.4||||0.684|TWO_SIDED|95.0|-8.3|5.5|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||5.5|-8.3|0.684
73845773|NCT00806585|147238331|SUPERIORITY_OR_OTHER||Difference in least squares means|1.8||||0.597|TWO_SIDED|95.0|-5.0|8.7|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||8.7|-5.0|0.597
73845774|NCT00806585|147238331|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0.793|TWO_SIDED|95.0|-7.6|5.8|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||5.8|-7.6|0.793
73845775|NCT00806585|147238331|SUPERIORITY_OR_OTHER||Difference in least squares means|0.8||||0.854|TWO_SIDED|95.0|-7.6|9.2|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||9.2|-7.6|0.854
73845776|NCT00806585|147238332|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.9||||0.006|TWO_SIDED|95.0|-3.2|-0.5|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.5|-3.2|0.006
73845777|NCT00806585|147238332|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.0||||0.004|TWO_SIDED|95.0|-3.3|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.6|-3.3|0.004
73845778|NCT00806585|147238332|SUPERIORITY_OR_OTHER||Diffference in least squares means|-1.3||||0.066|TWO_SIDED|95.0|-2.6|0.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.1|-2.6|0.066
73845779|NCT00806585|147238332|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.2||||0.008|TWO_SIDED|95.0|-3.7|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.6|-3.7|0.008
73845780|NCT00806585|147238333|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.18||||0.152|TWO_SIDED|95.0|-0.44|0.07|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.07|-0.44|0.152
73845781|NCT00806585|147238333|SUPERIORITY_OR_OTHER||Difference in least sqaures means|-0.28||||0.035|TWO_SIDED|95.0|-0.54|-0.02|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.02|-0.54|0.035
73845782|NCT00806585|147238333|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.22||||0.095|TWO_SIDED|95.0|-0.48|0.04|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.04|-0.48|0.095
73845783|NCT00806585|147238333|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.32||||0.045|TWO_SIDED|95.0|-0.63|-0.01|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.01|-0.63|0.045
73845784|NCT00474903|147238334|SUPERIORITY_OR_OTHER|||||||0.0955|||||||Wilcoxon (Mann-Whitney)|||||||0.0955
73845785|NCT00474903|147238334|SUPERIORITY_OR_OTHER|||||||0.0204|||||||Wilcoxon (Mann-Whitney)|||||||0.0204
73845786|NCT03435380|147238351|SUPERIORITY||Risk Ratio (RR)|2.37||||0.019|TWO_SIDED|95.0|1.11|5.07|||Mantel Haenszel|Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).||||5.07|1.11|0.019
73845787|NCT03435380|147238351|SUPERIORITY||Risk Ratio (RR)|1.96||||0.092|TWO_SIDED|95.0|0.87|4.38|||Mantel Haenszel|Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).||||4.38|0.87|0.092
73845788|NCT01103414|147238367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.1|STANDARD_ERROR_OF_MEAN|6.77||0.1819|TWO_SIDED|95.0|-22.4|4.3|||ANCOVA|||||4.3|-22.4|0.1819
73845789|NCT01103414|147238367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.4|STANDARD_ERROR_OF_MEAN|6.59||0.0057|TWO_SIDED|95.0|-31.4|-5.4|||ANCOVA|||||-5.4|-31.4|0.0057
73959939|NCT00762619|147455263|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959940|NCT00762619|147455264|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845790|NCT01103414|147238367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.9|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|-42.3|-15.6|||ANCOVA|||||-15.6|-42.3|<0.0001
73845791|NCT01103414|147238367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|-43.8|-18.2|||ANCOVA|||||-18.2|-43.8|<0.0001
73959941|NCT00762619|147455265|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959942|NCT00762619|147455266|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845792|NCT01103414|147238368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.0273|TWO_SIDED|95.0|-0.73|-0.04|||ANCOVA|||||-0.04|-0.73|0.0273
73845793|NCT01103414|147238368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.13|-0.45|||ANCOVA|||||-0.45|-1.13|<0.0001
73845794|NCT01103414|147238368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|0.176|<|0.0001|TWO_SIDED|95.0|-1.21|-0.52|||ANCOVA|||||-0.52|-1.21|<0.0001
73845795|NCT01103414|147238368|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.98|STANDARD_ERROR_OF_MEAN|0.169|<|0.0001|TWO_SIDED|95.0|-1.32|-0.65|||ANCOVA|||||-0.65|-1.32|<0.0001
73845796|NCT02519842|147238385|OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|-7.6|27.9|||||Mean difference in percentage of participants who experienced at least 1 tier 2 AE and received fosaprepitant regimen compared with participants who received control regimen.|||27.9|-7.6|
73845797|NCT02519842|147238386|OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|-5.1|17.8|||||Mean difference in percentage of participants who discontinued due to an AE and received fosaprepitant regimen compared with participants who received control regimen.|||17.8|-5.1|
73845798|NCT02319486|147238395|SUPERIORITY_OR_OTHER||Probability of Event-Free Survival ，pEFS|0.32||||0.034|TWO_SIDED|||||stage 2 vs stage 3|pEFS||over all pEFS|||||0.034
73845799|NCT03218917|147238410|SUPERIORITY||||||=|0.014||||||P-value is one-sided for superiority.|Stratified Log-rank test|Stratified by Pseudomonas aeruginosa (Pa) colonization status and maintenance antibiotic use at Baseline.||||||= 0.014
73845800|NCT03218917|147238410|SUPERIORITY||||||=|0.022||||||P-value is one-sided for superiority.|Stratified Log-rank test|Stratified by colonization status and maintenance antibiotic use at Baseline.||||||= 0.022
73845801|NCT00427193|147238415|OTHER||difference in mean change|0.02|STANDARD_DEVIATION|0.02||0.7|TWO_SIDED|95.0|-0.019|0.059||Type I error was controlled using a hierarchical gatekeeping strategy.|Mixed Models Analysis|||All analysis under intention-to-treat. All observations were included The primary analytic was a repeated measures analysis. The dependent variable was the change from baseline 12 \& 14mos., with treatment, time, and the treatment × time interaction as independent variables. Site, sex, BMI stratum, and the baseline value of the outcome were included as covariates. The predicted mean changes ± standard errors are the adjusted values from the contrasts of the multiple timepoints.||0.059|-0.019|0.70
73845802|NCT00427193|147238416|OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.84|TWO_SIDED|95.0|-0.0092|0.069|||Mixed Models Analysis|||||0.069|-0.0092|0.84
73845803|NCT00427193|147238417|OTHER||Mean Difference (Net)|-82.0|STANDARD_ERROR_OF_MEAN|11.12|<|0.001|TWO_SIDED|95.0|-103.8|-60.2|||Mixed Models Analysis|||||-60.2|-103.8|<0.001
73845804|NCT00427193|147238418|OTHER||Mean Difference (Final Values)|-64.0|STANDARD_DEVIATION|13.5|<|0.0001|TWO_SIDED|95.0|-90.5|-37.5|||Mixed Models Analysis|||||-37.5|-90.5|<0.0001
73845805|NCT00427193|147238419|OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.82|TWO_SIDED|95.0|-0.16|0.23|||Mixed Models Analysis|||||0.23|-0.16|0.82
73845806|NCT00427193|147238420|OTHER||Mean Difference (Net)|-5.9|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-6.5|-5.3|||Mixed Models Analysis|||Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) and Fat Free Mass (FFM) were determined for the whole body.||-5.3|-6.5|<0.001
73845807|NCT00427193|147238421|OTHER||Mean Difference (Net)|-5.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-6.4|-5.3|||Mixed Models Analysis|||Comparison of change in FM in 2 groups over at 24 mos, controlling for site, sex, BMI group, and baseline FM. A repeated measures Mixed Model was employed for the analysis. For any outcome, Type I error was controlled using a hierarchical gatekeeping strategy testing, first, the GroupXTime interaction, and, if non-significant, the main effects of these two factors. Bonferroni corrections were employed for non-significant effects. All tests were at p\<0.05||-5.3|-6.4|<0.0001
73845808|NCT01788943|147238422|OTHER|||||||0.037|||||||ANOVA|||||||0.037
73845809|NCT01788943|147238423|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
73845810|NCT00565409|147238443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|3.2|9.0||P-value from Cochran-Mantel-Haenszel(CMH) test of general association, testing treatment effect on response. P-value and Odds Ratio (OR) stratified by geographic region.|Cochran-Mantel-Haenszel|Loss of efficacy (LOE) imputation defined as LOE drop-outs were treated as non-responders/all other participants had LOCF applied as primary analysis.||Sample size estimated based on moderate/severe rheumatoid arthritis(RA) trial. Study design included only moderate RA participants, thus a low disease activity estimate of 85% (ETN+MTX) vs 70% (MTX only) assumed, required 175 randomized participants in 3 treatments for a 90% power and Type I error of 0.05 to reject the null hypothesis of no ETN+MTX vs MTX only differences. More participants qualified for Period 2 than expected, Period 2 sample size roughly 15% larger than protocol-specified.||9.0|3.2|<0.0001
73845811|NCT00565409|147238443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.3805|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.||||2.0|0.7|0.3805
73845812|NCT00565409|147238443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.||||7.6|3.0|<0.0001
73845813|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.11||||0.0853|TWO_SIDED|95.0|0.5|21.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||21.4|0.5|0.0853
73959943|NCT00762619|147455267|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959944|NCT00762619|147455268|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959945|NCT00762619|147455269|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959946|NCT00762619|147455270|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74022477|NCT00393718|147597247|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.91|||<|0.0001||95.0|-2.34|-1.48||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-1.48|-2.34|<0.0001
74022478|NCT00393718|147597248|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.71||||||95.0|-2.25|-1.18|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.18|-2.25|
74022479|NCT00393718|147597249|SUPERIORITY_OR_OTHER||Rate ratio|0.2||||||95.0|0.12|0.35|||Negative binomial regression model|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.35|0.12|
74022480|NCT00393718|147597249|SUPERIORITY_OR_OTHER||Rate ratio|0.18||||||95.0|0.09|0.36|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.36|0.09|
74022481|NCT00393718|147597249|SUPERIORITY_OR_OTHER||Rate ratio|0.2||||||95.0|0.11|0.34|||Negative binomial regression model|||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.34|0.11|
73845814|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8491|TWO_SIDED|95.0|0.2|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||4.8|0.2|0.8491
73845815|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97||||0.1278|TWO_SIDED|95.0|0.4|42.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||42.5|0.4|0.1278
73845816|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||6.4|2.1|<0.0001
73845817|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.3027|TWO_SIDED|95.0|0.8|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||2.7|0.8|0.3027
74022482|NCT03293654|147597301|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.28|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.18|1.39|||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.|||1.39|1.18|
74022483|NCT03293654|147597301|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.12|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.03|1.22|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator.|||1.22|1.03|
74022484|NCT03293654|147597301|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.14|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.05|1.24|||||Ratio of GLSM, EU is the numerator and US Avastin acts as the denominator|||1.24|1.05|
74022485|NCT03293654|147597302|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.16|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.09|1.22|||||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator|1.22|1.09|
74022486|NCT03293654|147597302|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.16|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.09|1.22|||||MB02 represents the numerator and EU Avastin represents the denominator|||1.22|1.09|
74022487|NCT03293654|147597302|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.07|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.0|1.13|||||EU Avastin corresponds to the numerator and US Avastin corresponds to the denominator|||1.13|1|
73845818|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|||<|0.0001|TWO_SIDED|95.0|1.5|4.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||4.2|1.5|<0.0001
73845819|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.55|||<|0.0001|TWO_SIDED|95.0|2.7|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||7.6|2.7|<0.0001
73845820|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.5871|TWO_SIDED|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||2.1|0.7|0.5871
73845821|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.3|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||6.1|2.3|<0.0001
73845822|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.52|||<|0.0001|TWO_SIDED|95.0|3.9|11.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||11.0|3.9|<0.0001
73845823|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.6716|TWO_SIDED|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||2.0|0.6|0.6716
73845824|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|95.0|3.4|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||8.6|3.4|<0.0001
73845825|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.62|||<|0.0001|TWO_SIDED|95.0|2.8|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||7.6|2.8|<0.0001
73845826|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.9399|TWO_SIDED|95.0|0.5|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||1.5|0.5|0.9399
73845827|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.78|||<|0.0001|TWO_SIDED|95.0|3.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||7.7|3.0|<0.0001
73845828|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.25|||<|0.0001|TWO_SIDED|95.0|3.7|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||10.5|3.7|<0.0001
73845829|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.6692|TWO_SIDED|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||1.9|0.6|0.6692
73845830|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.46|||<|0.0001|TWO_SIDED|95.0|3.4|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||8.7|3.4|<0.0001
73845831|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.4|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||9.8|3.4|<0.0001
73845832|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.4326|TWO_SIDED|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||2.1|0.7|0.4326
73845833|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.12|||<|0.0001|TWO_SIDED|95.0|3.2|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||8.2|3.2|<0.0001
73845834|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|2.8|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||7.8|2.8|<0.0001
73845835|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.6064|TWO_SIDED|95.0|0.6|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||1.8|0.6|0.6064
73845836|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|3.0|7.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||7.4|3.0|<0.0001
73845837|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.4626|TWO_SIDED|95.0|0.5|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||3.3|0.5|0.4626
73845838|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.2886|TWO_SIDED|95.0|0.6|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||3.3|0.6|0.2886
73959947|NCT00762619|147455271|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845839|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.7779|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||1.9|0.4|0.7779
73845840|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.8|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||4.7|1.8|<0.0001
73845841|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.2091|TWO_SIDED|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||2.0|0.8|0.2091
73845842|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.5|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||3.6|1.5|<0.0001
73845843|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.1|5.2||p-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||5.2|2.1|<0.0001
73845844|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5351|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||1.7|0.7|0.5351
73845845|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12|||<|0.0001|TWO_SIDED|95.0|2.0|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||4.8|2.0|<0.0001
73845846|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.0001|TWO_SIDED|95.0|2.6|6.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||6.5|2.6|<0.0001
73845847|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.4574|TWO_SIDED|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||1.3|0.5|0.4574
73845848|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.04|||<|0.0001|TWO_SIDED|95.0|3.2|8.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||8.0|3.2|<0.0001
73845849|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||6.6|2.7|<0.0001
73845850|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5229|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||1.8|0.7|0.5229
73845851|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84|||<|0.0001|TWO_SIDED|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||6.0|2.5|<0.0001
73845852|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|3.3|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||8.6|3.3|<0.0001
73898550|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.232||0.507|TWO_SIDED|95.0|-0.302|0.61||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.610|-0.302|0.507
73845853|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6464|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||1.8|0.7|0.6464
73845854|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.79|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||7.6|3.0|<0.0001
73845855|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96|||<|0.0001|TWO_SIDED|95.0|3.1|7.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission||7.9|3.1|<0.0001
73845856|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.5499|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission||1.7|0.7|0.5499
73845857|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.11|||<|0.0001|TWO_SIDED|95.0|2.6|6.4|||Cochran-Mantel-Haenszel|||Week 80 Remission||6.4|2.6|<0.0001
73845858|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.8|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||7.0|2.8|<0.0001
73845859|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.1109|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||1.9|0.8|0.1109
73845860|NCT00565409|147238445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.0001|TWO_SIDED|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||6.0|2.5|<0.0001
73845861|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||-0.4|-0.7|<0.0001
73845862|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9344|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||0.2|-0.2|0.9344
73845863|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||-0.4|-0.7|<0.0001
73845864|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||-0.7|-1.0|<0.0001
73845865|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.6173|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||0.2|-0.1|0.6173
73845866|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||-0.7|-1.1|<0.0001
73845867|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||-0.7|-1.1|<0.0001
73845868|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.5136|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||0.3|-0.1|0.5136
73845869|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||-0.8|-1.2|<0.0001
73845870|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||-0.7|-1.1|<0.0001
73845871|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.4868|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||0.3|-0.1|0.4868
73845872|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||-0.7|-1.1|<0.0001
73845873|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||-0.8|-1.3|<0.0001
73845874|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.7847|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||0.2|-0.2|0.7847
73845875|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||-0.8|-1.2|<0.0001
73845876|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||-0.8|-1.2|<0.0001
73845877|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.981|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||0.2|-0.2|0.9810
73845878|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||-0.8|-1.2|<0.0001
73845879|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||-0.8|-1.3|<0.0001
73845880|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3562|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||0.1|-0.3|0.3562
73845881|NCT00565409|147238447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||-0.7|-1.2|<0.0001
73845882|NCT00565409|147238448|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||<0.0001
73845883|NCT00565409|147238448|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||<0.0001
73845884|NCT00565409|147238448|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||0.8622
73845885|NCT00565409|147238449|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||<0.0001
73845886|NCT00565409|147238449|SUPERIORITY_OR_OTHER|||||||0.9841|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||0.9841
73845887|NCT00565409|147238449|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||<0.0001
73845888|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
73845889|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8015|TWO_SIDED|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.3|0.8015
73845890|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
73845891|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.7|-1.5|<0.0001
73845892|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.8534|TWO_SIDED|95.0|-0.4|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.4|-0.4|0.8534
73845893|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.8|-1.6|<0.0001
73845894|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.7|<0.0001
73845895|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9074|TWO_SIDED|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.5|-0.4|0.9074
73845896|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.7|<0.0001
73845897|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.8|<0.0001
73845898|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.9229|TWO_SIDED|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.5|-0.4|0.9229
73845899|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.8|<0.0001
73845900|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.9|<0.0001
73845901|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9279|TWO_SIDED|95.0|-0.5|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.4|-0.5|0.9279
73845902|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.9|<0.0001
73845903|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.1|-2.1|<0.0001
73845904|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.7695|TWO_SIDED|95.0|-0.6|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.4|-0.6|0.7695
73845905|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-2.0|<0.0001
73845906|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.2|-2.3|<0.0001
73959948|NCT00762619|147455272|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845907|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.2182|TWO_SIDED|95.0|-0.8|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.2|-0.8|0.2182
73845908|NCT00565409|147238453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-0.9|-1.9|<0.0001
73845909|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.0003|TWO_SIDED|95.0|-1.3|-0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.4|-1.3|0.0003
73845910|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.6088|TWO_SIDED|95.0|-0.3|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.6|-0.3|0.6088
73845911|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.4|<0.0001
73845912|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.4|-2.6|<0.0001
73845913|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.9048|TWO_SIDED|95.0|-0.5|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANOVA|||Week 48||0.6|-0.5|0.9048
73845914|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.5|-2.6|<0.0001
73845915|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-1.5|-2.6|<0.0001
73845916|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8437|TWO_SIDED|95.0|-0.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.5|-0.6|0.8437
73845917|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-1.4|-2.6|<0.0001
73845918|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.4|-2.6|<0.0001
73898551|NCT02880956|147328897|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73845919|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.8587|TWO_SIDED|95.0|-0.6|0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.7|-0.6|0.8587
73845920|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.4|-2.6|<0.0001
73845921|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.8|-3.0|<0.0001
73845922|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.6323|TWO_SIDED|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.5|-0.8|0.6323
73845923|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.23|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.6|-2.9|<0.0001
73845924|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.6|-2.9|<0.0001
73845925|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.6558|TWO_SIDED|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.5|-0.8|0.6558
73845926|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.5|-2.8|<0.0001
73845927|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.7|-3.1|<0.0001
73898552|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.216||0.233|TWO_SIDED|95.0|-0.683|0.167||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.167|-0.683|0.233
73898553|NCT02880956|147328897|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|1.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73959949|NCT00762619|147455273|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73845928|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8688|TWO_SIDED|95.0|-0.7|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.6|-0.7|0.8688
73845929|NCT00565409|147238456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.7|-3.0|<0.0001
73845930|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.0|<0.0001
73845931|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9636|TWO_SIDED|95.0|-0.2|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.2|0.9636
73845932|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.0|<0.0001
73845933|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.8|-1.4|<0.0001
73845934|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.4605|TWO_SIDED|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.4|-0.2|0.4605
73845935|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.9|-1.5|<0.0001
73845936|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.4|<0.0001
73845937|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8404|TWO_SIDED|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.3|-0.3|0.8404
73845938|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.9|-1.4|<0.0001
73845939|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.4|<0.0001
73845940|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.3118|TWO_SIDED|95.0|-0.1|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.5|-0.1|0.3118
73845941|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.0|-1.6|<0.0001
73845942|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-0.9|-1.6|<0.0001
73845943|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.61|TWO_SIDED|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.4|-0.2|0.6100
73845944|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.6|<0.0001
73845945|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-1.6|<0.0001
73845946|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.6552|TWO_SIDED|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.2|-0.4|0.6552
73845947|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-1.6|<0.0001
73845948|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.1|-1.8|<0.0001
73898554|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.211||0.881|TWO_SIDED|95.0|-0.383|0.446||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.446|-0.383|0.881
73845949|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.4753|TWO_SIDED|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.2|-0.4|0.4753
73845950|NCT00565409|147238459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.0|-1.6|<0.0001
73845951|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.6|-1.2|<0.0001
73845952|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.7427|TWO_SIDED|95.0|-0.4|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.4|0.7427
73845953|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
73845954|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.1|-1.7|<0.0001
73845955|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.3129|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.2|-0.5|0.3129
74022488|NCT03293654|147597309|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.02|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.962|1.07|||||MB02 in numerator and EU Avastin in denominator|||1.07|0.962|
73845956|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.9|-1.6|<0.0001
73845957|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.9|-1.6|<0.0001
73845958|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.4645|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.2|-0.5|0.4645
73845959|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.5|<0.0001
73845960|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.9|-1.7|<0.0001
73845961|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.3793|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.2|-0.5|0.3793
73845962|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.5|<0.0001
73845963|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.2|-2.0|<0.0001
73845964|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0816|TWO_SIDED|95.0|-0.7|0.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.0|-0.7|0.0816
73845965|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-0.9|-1.6|<0.0001
73845966|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.2|-1.9|<0.0001
73845967|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0256|TWO_SIDED|95.0|-0.8|-0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-0.1|-0.8|0.0256
73845968|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-0.8|-1.5|<0.0001
73845969|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.2|-1.9|<0.0001
73845970|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.1158|TWO_SIDED|95.0|-0.7|0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.1|-0.7|0.1158
73845971|NCT00565409|147238462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-0.9|-1.6|<0.0001
73845972|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.67||||0.0214|TWO_SIDED|95.0|-77.1|-6.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-6.2|-77.1|0.0214
73898555|NCT02880956|147328897|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|1.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898556|NCT02880956|147328897|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.217||0.671|TWO_SIDED|95.0|-0.52|0.335||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.335|-0.520|0.671
73845973|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.57||||0.5544|TWO_SIDED|95.0|-45.6|24.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||24.5|-45.6|0.5544
73898557|NCT02880956|147328897|OTHER||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73845974|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1||||0.0826|TWO_SIDED|95.0|-66.2|4.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||4.0|-66.2|0.0826
73845975|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-80.05||||0.0001|TWO_SIDED|95.0|-120.3|-39.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-39.8|-120.3|0.0001
73898558|NCT02880956|147328898|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.409||0.297|TWO_SIDED|95.0|-1.232|0.377||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.377|-1.232|0.297
73898559|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|3.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898560|NCT02880956|147328898|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.405||0.979|TWO_SIDED|95.0|-0.808|0.786||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.786|-0.808|0.979
73959950|NCT00762619|147455274|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959951|NCT00762619|147455275|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959952|NCT00762619|147455276|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959953|NCT00762619|147455277|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959954|NCT00762619|147455278|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959955|NCT00762619|147455279|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959956|NCT00762619|147455280|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959957|NCT00762619|147455281|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959958|NCT00762619|147455282|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959959|NCT00762619|147455283|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959960|NCT00762619|147455284|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959961|NCT00762619|147455285|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959962|NCT00762619|147455286|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959963|NCT00762619|147455287|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959964|NCT00762619|147455288|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898561|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|3.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898562|NCT02880956|147328898|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.415||0.663|TWO_SIDED|95.0|-0.996|0.634||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.634|-0.996|0.663
73898563|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|3.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898564|NCT02880956|147328898|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.636||0.961|TWO_SIDED|95.0|-1.22|1.282||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.282|-1.220|0.961
73898565|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898566|NCT02880956|147328898|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.617||0.833|TWO_SIDED|95.0|-1.083|1.344||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.344|-1.083|0.833
73898567|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|5.06|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898568|NCT02880956|147328898|OTHER||LS Mean of Difference|0.23|STANDARD_ERROR_OF_MEAN|0.636||0.714|TWO_SIDED|95.0|-1.017|1.484||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.484|-1.017|0.714
73898569|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|5.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898570|NCT02880956|147328898|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.663||0.518|TWO_SIDED|95.0|-1.733|0.876||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.876|-1.733|0.518
74022489|NCT03293654|147597309|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.06|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.996|1.13|||||MB02 is numerator and US Avastin is denominator|||1.13|0.996|
73898571|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|5.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898572|NCT02880956|147328898|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.654||0.633|TWO_SIDED|95.0|-1.598|0.973||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.973|-1.598|0.633
73898573|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|4.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898574|NCT02880956|147328898|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.661||0.776|TWO_SIDED|95.0|-1.488|1.112||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.112|-1.488|0.776
73898575|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|4.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898576|NCT02880956|147328898|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.58||0.316|TWO_SIDED|95.0|-1.723|0.558||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.558|-1.723|0.316
73898577|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|4.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898578|NCT02880956|147328898|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.567||0.336|TWO_SIDED|95.0|-1.66|0.569||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.569|-1.660|0.336
73898579|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898580|NCT02880956|147328898|SUPERIORITY||LS Mean of Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.587||0.403|TWO_SIDED|95.0|-1.647|0.663||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.663|-1.647|0.403
73898581|NCT02880956|147328898|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898582|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.4||0.861|TWO_SIDED|95.0|-0.856|0.716||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.716|-0.856|0.861
73898583|NCT02880956|147328899|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|3.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898584|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.395||0.746|TWO_SIDED|95.0|-0.648|0.905||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.905|-0.648|0.746
73898585|NCT02880956|147328899|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|3.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898586|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.405||0.859|TWO_SIDED|95.0|-0.724|0.868||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.868|-0.724|0.859
73898587|NCT02880956|147328899|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898588|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|0.55|STANDARD_ERROR_OF_MEAN|0.467||0.24|TWO_SIDED|95.0|-0.369|1.469||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.469|-0.369|0.240
73898589|NCT02880956|147328899|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|3.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898590|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|0.91|STANDARD_ERROR_OF_MEAN|0.454||0.044|TWO_SIDED|95.0|0.023|1.087||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.087|0.023|0.044
73959965|NCT00762619|147455289|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898591|NCT02880956|147328899|SUPERIORITY||Effect size/pooled SD|0.26|STANDARD_DEVIATION|3.51|||TWO_SIDED|||||||||Week 48||||
73898592|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|0.61|STANDARD_ERROR_OF_MEAN|0.467||0.195|TWO_SIDED|95.0|-0.312|1.524||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.524|-0.312|0.195
73898593|NCT02880956|147328899|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|3.53|||TWO_SIDED|||||||||Week 48||||
73898594|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.547||0.778|TWO_SIDED|95.0|-0.921|1.229||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.229|-0.921|0.778
73898595|NCT02880956|147328899|OTHER||Effect size/pooled SD|0.04|STANDARD_DEVIATION|3.99|||TWO_SIDED|||||||||Week 72||||
73898596|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.539||0.558|TWO_SIDED|95.0|-0.743|1.376||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.376|-0.743|0.558
73898597|NCT02880956|147328899|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|3.89|||TWO_SIDED|||||||||Week 72||||
73898598|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.546||0.928|TWO_SIDED|95.0|-1.025|1.124||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.124|-1.025|0.928
73898599|NCT02880956|147328899|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.27|||TWO_SIDED|||||||||Week 72||||
73898600|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|0.64|STANDARD_ERROR_OF_MEAN|0.541||0.238|TWO_SIDED|95.0|-0.425|1.704||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.704|-0.425|0.238
73898601|NCT02880956|147328899|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898602|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|0.86|STANDARD_ERROR_OF_MEAN|0.53||0.107|TWO_SIDED|95.0|-0.186|1.898||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.898|-0.186|0.107
73898603|NCT02880956|147328899|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|3.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73959966|NCT00762619|147455290|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959967|NCT00762619|147455291|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959968|NCT00762619|147455292|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898604|NCT02880956|147328899|SUPERIORITY||LS Mean of Difference|0.86|STANDARD_ERROR_OF_MEAN|0.548||0.116|TWO_SIDED|95.0|-0.214|1.942||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.942|-0.214|0.116
73898605|NCT02880956|147328899|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|3.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898606|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.186||0.683|TWO_SIDED|95.0|-0.442|0.29||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.290|-0.442|0.683
73898607|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898608|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.184||0.973|TWO_SIDED|95.0|-0.356|0.368||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.368|-0.356|0.973
73898609|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898610|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.189||0.921|TWO_SIDED|95.0|-0.389|0.352||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.352|-0.389|0.921
73898611|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73959969|NCT00762619|147455293|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959970|NCT00762619|147455294|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959971|NCT00762619|147455295|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74088240|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.16|-0.55|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.55|-1.16|<.0001
73898612|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.256||0.335|TWO_SIDED|95.0|-0.751|0.257||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.257|-0.751|0.335
73898613|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|2.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898614|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.249||0.67|TWO_SIDED|95.0|-0.383|0.596||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.596|-0.383|0.670
73898615|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|2.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898616|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.256||0.95|TWO_SIDED|95.0|-0.486|0.519||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.519|-0.486|0.950
73898617|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|2.04|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898618|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.257||0.383|TWO_SIDED|95.0|-0.729|0.281||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.281|-0.729|0.383
73898619|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|2.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898620|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.254||0.985|TWO_SIDED|95.0|-0.504|0.494||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.494|-0.504|0.985
73959972|NCT00762619|147455296|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959973|NCT00762619|147455297|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959974|NCT00762619|147455298|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959975|NCT00762619|147455299|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898621|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|2.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898622|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.256||0.064|TWO_SIDED|95.0|-0.982|0.027||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.027|-0.982|0.064
73898623|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|2.4|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898624|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.28||0.527|TWO_SIDED|95.0|-0.374|0.729||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.729|-0.374|0.527
73898625|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898626|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|0.31|STANDARD_ERROR_OF_MEAN|0.275||0.254|TWO_SIDED|95.0|-0.226|0.854||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.854|-0.226|0.254
73898627|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|2.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
74022490|NCT03293654|147597309|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.983|1.11|||||EU Avastin in the numerator and US Avastin in the denominator|||1.11|0.983|
74022491|NCT03293654|147597310|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.02|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.969|1.07|||||MB02: EU Avastin|||1.07|0.969|
73898628|NCT02880956|147328900|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.284||0.805|TWO_SIDED|95.0|-0.628|0.488||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.488|-0.628|0.805
73898629|NCT02880956|147328900|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898630|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.361||0.534|TWO_SIDED|95.0|-0.935|0.485||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.485|-0.935|0.534
73898631|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898632|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.356||0.735|TWO_SIDED|95.0|-0.58|0.821||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.821|-0.580|0.735
73898633|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898634|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.365||0.009|TWO_SIDED|95.0|-1.673|-0.24||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.240|-1.673|0.009
73898635|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|-0.35|STANDARD_DEVIATION|2.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898636|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.422||0.954|TWO_SIDED|95.0|-0.854|0.806||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.806|-0.854|0.954
73898637|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|2.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898638|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|0.412||0.649|TWO_SIDED|95.0|-0.622|0.997||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.997|-0.622|0.649
73959976|NCT00762619|147455300|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898639|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|2.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898640|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.423||0.358|TWO_SIDED|95.0|-1.22|0.443||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.443|-1.220|0.358
73898641|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|2.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898642|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.539||0.859|TWO_SIDED|95.0|-1.155|0.963||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.963|-1.155|0.859
73898643|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|3.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898644|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.529||0.455|TWO_SIDED|95.0|-0.644|1.437||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.437|-0.644|0.455
73898645|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|3.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898646|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.538||0.335|TWO_SIDED|95.0|-1.578|0.539||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.539|-1.578|0.335
73898647|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|3.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898648|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.681||0.875|TWO_SIDED|95.0|-1.447|1.233||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.233|-1.447|0.875
73898649|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898650|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|0.668||0.712|TWO_SIDED|95.0|-1.068|1.561||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.561|-1.068|0.712
73898651|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|4.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898652|NCT02880956|147328901|SUPERIORITY||LS Mean of Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.687||0.269|TWO_SIDED|95.0|-2.112|0.59||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.590|-2.112|0.269
73898653|NCT02880956|147328901|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898654|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.785||0.966|TWO_SIDED|95.0|-1.509|1.577||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.577|-1.509|0.966
73898655|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|6.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898656|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.775||0.874|TWO_SIDED|95.0|-1.646|1.4||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.400|-1.646|0.874
73898657|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|5.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898658|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|0.99|STANDARD_ERROR_OF_MEAN|0.794||0.213|TWO_SIDED|95.0|-0.572|2.551||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||2.551|-0.572|0.213
73898659|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|6.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73959977|NCT00762619|147455301|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898660|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|0.88|STANDARD_ERROR_OF_MEAN|0.695||0.208|TWO_SIDED|95.0|-0.49|2.242||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.242|-0.490|0.208
73898661|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|5.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898662|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|1.03|STANDARD_ERROR_OF_MEAN|0.68||0.131|TWO_SIDED|95.0|-0.307|2.365||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.365|-0.307|0.131
73898663|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|5.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898664|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|1.35|STANDARD_ERROR_OF_MEAN|0.695||0.052|TWO_SIDED|95.0|-0.014|2.719||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.719|-0.014|0.052
73845976|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.18||||0.0344|TWO_SIDED|95.0|-83.2|-3.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-3.2|-83.2|0.0344
73845977|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.87||||0.0721|TWO_SIDED|95.0|-77.1|3.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||3.3|-77.1|0.0721
73845978|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-89.19|||<|0.0001|TWO_SIDED|95.0|-128.7|-49.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-49.7|-128.7|<0.0001
73845979|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.14||||0.191|TWO_SIDED|95.0|-65.4|13.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||13.1|-65.4|0.1910
73845980|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.05||||0.0018|TWO_SIDED|95.0|-102.5|-23.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-23.6|-102.5|0.0018
73898665|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|-0.24|STANDARD_DEVIATION|5.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898666|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|1.062||0.866|TWO_SIDED|95.0|-1.908|2.268||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.268|-1.908|0.866
73898667|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|6.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898668|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|0.46|STANDARD_ERROR_OF_MEAN|1.048||0.66|TWO_SIDED|95.0|-1.599|2.523||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.523|-1.599|0.660
73898669|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|6.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898670|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|1.91|STANDARD_ERROR_OF_MEAN|1.062||0.074|TWO_SIDED|95.0|-0.184|3.995||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||3.995|-0.184|0.074
73898671|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|-0.22|STANDARD_DEVIATION|8.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73845981|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-84.36||||0.0002|TWO_SIDED|95.0|-129.1|-39.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-39.6|-129.1|0.0002
73845982|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.935|TWO_SIDED|95.0|-46.3|42.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||42.6|-46.3|0.9350
73845983|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-82.52||||0.0003|TWO_SIDED|95.0|-127.2|-37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-37.8|-127.2|0.0003
73845984|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-108.73|||<|0.0001|TWO_SIDED|95.0|-157.0|-60.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-60.4|-157.0|<0.0001
73845985|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.6764|TWO_SIDED|95.0|-58.2|37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||37.8|-58.2|0.6764
73898672|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|-0.36|STANDARD_ERROR_OF_MEAN|1.111||0.747|TWO_SIDED|95.0|-2.545|1.828||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.828|-2.545|0.747
74084358|NCT01067521|147721929|SUPERIORITY||Risk Ratio (RR)|0.8332|STANDARD_ERROR_OF_MEAN|0.0744||0.0409|TWO_SIDED|95.0|0.6995|0.9925||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Entire Study The Negative Binomial Regression model covariates: • treatment group • PCBL (Placebo-Controlled Baseline) Kurtzke's Expanded Disability Status Scale (EDSS) score as 1 degree of freedom variable • Log of the # of relapses in the 2 years prior to PCBL • Volume of T2 lesions at PCBL • Status of Gd-enhancing T1 lesion activity at PCBL (=0 if no Gd-enhancing T1 lesions at PCBL; =1 if at least one Gd-enhancing T1 lesion at PCBL) • Country or Geographical Region (CGR)||0.9925|0.6995|0.0409
73845986|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-98.53|||<|0.0001|TWO_SIDED|95.0|-146.7|-50.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-50.3|-146.7|<0.0001
73845987|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-115.48|||<|0.0001|TWO_SIDED|95.0|-157.7|-73.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-73.3|-157.7|<0.0001
73845988|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69||||0.5219|TWO_SIDED|95.0|-55.6|28.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||28.3|-55.6|0.5219
73845989|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.8|||<|0.0001|TWO_SIDED|95.0|-144.0|-59.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-59.6|-144.0|<0.0001
73845990|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-71.6||||0.002|TWO_SIDED|95.0|-116.9|-26.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-26.3|-116.9|0.0020
73845991|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3||||0.5917|TWO_SIDED|95.0|-32.7|57.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||57.3|-32.7|0.5917
73845992|NCT00565409|147238465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.91||||0.0003|TWO_SIDED|95.0|-129.2|-38.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-38.7|-129.2|0.0003
73845993|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.79|||<|0.0001|TWO_SIDED|95.0|-11.9|-5.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-5.7|-11.9|<0.0001
73845994|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55||||0.1033|TWO_SIDED|95.0|-5.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.5|-5.6|0.1033
73845995|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|||<|0.0001|TWO_SIDED|95.0|-9.3|-3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-3.1|-9.3|<0.0001
73845996|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||<|0.0001|TWO_SIDED|95.0|-15.4|-8.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-8.8|-15.4|<0.0001
73845997|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.6802|TWO_SIDED|95.0|-4.0|2.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||2.6|-4.0|0.6802
73845998|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.39|||<|0.0001|TWO_SIDED|95.0|-14.7|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-8.1|-14.7|<0.0001
73845999|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||<|0.0001|TWO_SIDED|95.0|-15.6|-8.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-8.6|-15.6|<0.0001
73846000|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.4404|TWO_SIDED|95.0|-4.8|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||2.1|-4.8|0.4404
73846001|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|||<|0.0001|TWO_SIDED|95.0|-14.2|-7.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-7.2|-14.2|<0.0001
73846002|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.83|||<|0.0001|TWO_SIDED|95.0|-16.2|-9.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-9.4|-16.2|<0.0001
73898673|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|7.99|||TWO_SIDED|||||||||Week 96||||
74022492|NCT03293654|147597310|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.06|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.998|1.12|||||MB02: US Avastin|||1.12|0.998|
73898674|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|1.095||0.891|TWO_SIDED|95.0|-2.004|2.304||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.304|-2.004|0.891
73898675|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|8.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898676|NCT02880956|147328902|SUPERIORITY||LS Mean of Difference|0.55|STANDARD_ERROR_OF_MEAN|1.12||0.621|TWO_SIDED|95.0|-1.65|2.759||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.759|-1.650|0.621
73898677|NCT02880956|147328902|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|8.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73846003|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.4437|TWO_SIDED|95.0|-4.7|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||2.1|-4.7|0.4437
73846004|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.51|||<|0.0001|TWO_SIDED|95.0|-14.9|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-8.1|-14.9|<0.0001
73846005|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.79|||<|0.0001|TWO_SIDED|95.0|-18.5|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-11.1|-18.5|<0.0001
73846006|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.096|TWO_SIDED|95.0|-6.8|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.6|-6.8|0.0960
73898678|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.019||0.147|TWO_SIDED|95.0|-0.01|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.064|-0.010|0.147
73898679|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898680|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.018||0.795|TWO_SIDED|95.0|-0.041|0.031||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.031|-0.041|0.795
73898681|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|0.147|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73898682|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.019||0.095|TWO_SIDED|95.0|-0.006|0.069||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.069|-0.006|0.095
73898683|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|-0.24|STANDARD_DEVIATION|0.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
73846007|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.67|||<|0.0001|TWO_SIDED|95.0|-15.4|-8.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-8.0|-15.4|<0.0001
73898684|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.025||0.39|TWO_SIDED|95.0|-0.028|0.072||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.072|-0.028|0.390
73898685|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73959978|NCT00762619|147455302|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74022493|NCT03293654|147597310|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.981|1.1|||||EU Avastin: US Avastin|||1.1|0.981|
73846008|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.56|||<|0.0001|TWO_SIDED|95.0|-18.1|-11.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-11.0|-18.1|<0.0001
73898686|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.025||0.898|TWO_SIDED|95.0|-0.052|0.045||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.045|-0.052|0.898
73898687|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
73898688|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.026||0.8|TWO_SIDED|95.0|-0.044|0.057||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.057|-0.044|0.800
73898689|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.18|||TWO_SIDED|||||||||Week 48||||
73898690|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.977|TWO_SIDED|95.0|-0.066|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.064|-0.066|0.977
73898691|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898692|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.99|TWO_SIDED|95.0|-0.063|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.064|-0.063|0.990
73898693|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898694|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.944|TWO_SIDED|95.0|-0.063|0.067||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.067|-0.063|0.944
74022494|NCT03293654|147597311|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|0.986|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.903|1.08|||||MB02: EU Avastin|||1.08|0.903|
73898695|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
73898696|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.042||0.942|TWO_SIDED|95.0|-0.079|0.085||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.085|-0.079|0.942
73898697|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898698|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.041||0.876|TWO_SIDED|95.0|-0.087|0.074||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.074|-0.087|0.876
73898699|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73898700|NCT02880956|147328903|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.043||0.163|TWO_SIDED|95.0|-0.024|0.143||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.143|-0.024|0.163
73898701|NCT02880956|147328903|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|0.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
73959979|NCT00762619|147455303|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898702|NCT00576420|147328905|SUPERIORITY_OR_OTHER|||||||0.1564||90.0|||||Likelihood ratio chi-square test|||||||0.1564
73898703|NCT00576420|147328907|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Likelihood ratio chi-square test|||||||0.060
73898704|NCT00576420|147328907|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Likelihood ratio chi-square test|||||||0.005
73898705|NCT00576420|147328908|SUPERIORITY_OR_OTHER|||||||0.123||95.0|||||Likelihood ratio chi-square test|||||||0.123
73898706|NCT00576420|147328908|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Likelihood ratio chi-square test|||||||0.026
73959980|NCT00762619|147455304|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898707|NCT00576420|147328909|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Likelihood ratio chi-square test|||||||0.929
73898708|NCT00576420|147328909|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||Likelihood ratio chi-square test|||||||0.228
73898709|NCT00576420|147328911|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||Likelihood ratio chi-square test|||||||0.234
73898710|NCT00576420|147328911|SUPERIORITY_OR_OTHER|||||||0.955||95.0|||||Likelihood ratio chi-square test|||||||0.955
73959981|NCT00762619|147455305|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959982|NCT00762619|147455306|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898711|NCT00576420|147328912|SUPERIORITY_OR_OTHER|||||||0.106||95.0|||||Likelihood ratio chi-square test|||||||0.106
73898712|NCT00576420|147328912|SUPERIORITY_OR_OTHER|||||||0.243||95.0|||||Likelihood ratio chi-square test|||||||0.243
73898713|NCT00576420|147328912|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Likelihood ratio chi-square test|||||||0.127
73898714|NCT00576420|147328913|SUPERIORITY_OR_OTHER|||||||0.257||95.0|||||Likelihood ratio chi-square test|||||||0.257
73898715|NCT00576420|147328913|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||Likelihood ratio chi-square test|||||||0.096
73898716|NCT00576420|147328913|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Likelihood ratio chi-square test|||||||0.127
73898717|NCT01340872|147328936|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|ONE_SIDED|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|||1.81|< 0.0001
73898718|NCT01340872|147328940|SUPERIORITY||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|ONE_SIDED|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|||0.82|< 0.0001
73898719|NCT01340872|147328941|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|ONE_SIDED|97.5|1.43||||ANCOVA|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|||1.43|< 0.0001
73898720|NCT01340872|147328952|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|ONE_SIDED|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|||1.87|< 0.0001
73898721|NCT01340872|147328953|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|ONE_SIDED|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12|||1.82|< 0.0001
73898722|NCT01502332|147328962|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
73898723|NCT01502332|147328963|SUPERIORITY_OR_OTHER|||||||0.014|||||||Log Rank|||||||0.014
73898724|NCT01502332|147328964|SUPERIORITY_OR_OTHER|||||||0.037|||||||Log Rank|||||||0.037
73898725|NCT01502332|147328966|SUPERIORITY_OR_OTHER|||||||0.267|||||||Regression, Logistic|||||||0.267
73898726|NCT00830791|147328972|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.74||||0.325|TWO_SIDED|90.0|0.43|1.26|||ANCOVA||The mean square error on a log scale for this comparison was 0.322.|||1.26|0.43|0.325
74022495|NCT03293654|147597311|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.1|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.01|1.19|||||MB02: US Avastin|||1.19|1.01|
74022496|NCT03293654|147597311|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.12|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.02|1.22|||||EU Avastin: US Avastin|||1.22|1.02|
73898727|NCT00830791|147328973|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95||||0.718|TWO_SIDED|90.0|0.76|1.2|||ANCOVA||The mean square error on a log scale was 0.061 for this comparison.|||1.20|0.76|0.718
73898728|NCT00830791|147328974|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.63||||0.014|TWO_SIDED|90.0|1.21|2.2|||ANCOVA||The mean square error on a log scale was 0.104 for this comparison.|||2.20|1.21|0.014
73898729|NCT00830791|147328976|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.14||||0.505|TWO_SIDED|90.0|0.81|1.6|||ANCOVA||The mean square error on a log scale for this comparison was 0.133.|||1.60|0.81|0.505
73898730|NCT00830791|147328978|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.0|||||TWO_SIDED|90.0|0.0|0.5|||ANCOVA|||||0.50|0.00|
73898731|NCT00830791|147328979|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.0|||||TWO_SIDED|90.0|0.0|0.5|||ANCOVA|||||0.50|0.00|
73898732|NCT00789074|147329000|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
73898733|NCT00789074|147329001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.001
73898734|NCT00789074|147329002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||F=16.60|ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.001
73898735|NCT00789074|147329003|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||F=2.92|ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.04
73898736|NCT00789074|147329004|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||0.02
73898737|NCT00789074|147329005|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||0.97
73898738|NCT02564432|147329013|EQUIVALENCE|This is not a randomized clinical trial but is an observational study, each patient's thigh skin site served as the control.|Base mean abundance|0.03|||<|0.05|TWO_SIDED|||||The reported p-value was calculated.|Unweighted UniFrac (qualitative)|Both weighted and unweighted UniFrac were calculated; weighted UniFrac is calculated to be p = 0.398 while unweighted UniFrac was P\<0.03|Differential abundance of Staphylococcus aureus in the stoma calculated by Log2 fold change (y-axis) versus base mean abundance (x-axis)|Sample similarity was calculated using the statistical comparisons of community composition.||||<0.05
73898739|NCT02564432|147329013|OTHER|"In this study, dissimilarities between the stomal and healthy thigh skins were tested.~Observational study. Used only for visualizing trends in the data."|PERMANOVA|0.001|||<|0.005|TWO_SIDED|||||Each stomal community type was distinguished by both its diversity and taxonomic composition|Bray-Curtis dissimilarities|Nonmetric multidimensional scaling (NMDS) of Bray-Curtis dissimilarities|||Loess Regression was used to visualize temporal trends in the Shannnon Diversity and relative abundance of microbes (Staphylococcus, Streptococcus, Corynebacterium, and obligate anaerobes).|||<0.005
73898740|NCT03860935|147329015|SUPERIORITY||||||<|0.0001|||||||Finkelstein-Schoenfeld Method|||||||<0.0001
73959983|NCT00762619|147455307|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959984|NCT00762619|147455308|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898741|NCT03860935|147329016|SUPERIORITY||Least Squares Mean Difference|39.64|STANDARD_ERROR_OF_MEAN|9.477|<|0.0001|TWO_SIDED|96.0|20.18|59.1|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||59.10|20.18|<0.0001
73898742|NCT03860935|147329017|SUPERIORITY||Least Squares Mean Difference|9.94|STANDARD_ERROR_OF_MEAN|2.024|<|0.0001|TWO_SIDED|96.0|5.79|14.1|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||14.10|5.79|<0.0001
73898743|NCT03860935|147329018|SUPERIORITY||Least Squares Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|0.665|<|0.0001|TWO_SIDED|96.0|5.73|8.46|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||8.46|5.73|<0.0001
73898744|NCT03860935|147329019|SUPERIORITY||Relative Risk Reduction (%)|25.0||||0.0569|TWO_SIDED|||||Cochran-Mantel-Haenszel test is stratified by randomization stratification factors of genotype, NT-proBNP level and eGFR level as recorded in IXRS.|Cochran-Mantel-Haenszel|||||||0.0569
73898745|NCT03086967|147329020|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
73898746|NCT03086967|147329021|SUPERIORITY|||||||0.133|||||||t-test, 2 sided|||||||0.133
73898747|NCT03086967|147329022|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
73898748|NCT03086967|147329023|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73898749|NCT03086967|147329024|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
73898750|NCT03086967|147329025|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
74022497|NCT01355289|147597336|SUPERIORITY_OR_OTHER||Difference in % of Responders|31.62||||0.0236|TWO_SIDED|95.0|5.39|57.84|||Cochran-Mantel-Haenszel|||||57.84|5.39|0.0236
73898751|NCT03086967|147329026|SUPERIORITY|||||||0.98|||||||Chi-squared|||||||0.98
73898752|NCT03086967|147329027|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
73898753|NCT03086967|147329028|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
73898754|NCT03086967|147329029|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
73898755|NCT03086967|147329030|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
73898756|NCT01733212|147329051|EQUIVALENCE|Considering the null hypothesis that the number of participants who will have vomiting will be equal in the two arms, we performed this study with a significance level of 0.05% and power of 80% to prove that there is a difference in the number.||||||0.07|||||||Chi-squared|||Number of participants who had vomiting in each group is compared to the other. Two sided Chi square test was conducted, Type I error of 0.05% and power of 80% are considered.||||0.07
73898757|NCT00775203|147329052|SUPERIORITY_OR_OTHER|||||||0.0119|||||||ANCOVA|ANCOVA with treatment and study center as categorical factors and HAMD-17 baseline as covariate.||The primary null hypothesis for the HAMD-17 total score is that there is no difference between the Trazodone Contramid® OAD group and the placebo group at Week 8. A sample size of 133 in each group will have 90% power to detect a difference in the absolute mean Hamilton Rating Scale for Depression (HAMD-17) change from baseline of 3.0 units assuming that the common standard deviation is 7.5 using a two-group t-test with a 0.05 two-sided significance level.||||0.0119
73898758|NCT01105065|147329087|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared, Corrected|||There would be no change in retinal vascular dysregulation after treatment with brimonidine||||<0.0001
73898759|NCT01105065|147329088|SUPERIORITY_OR_OTHER|||||||0.28|||||||paired t-test|||A paired t-test was used to determine if their was a statistically significant difference between the mean deviation of the frequency doubling perimetry in the RVD patients pre and post brimonidine treatment.||||0.28
73898760|NCT02984943|147329089|OTHER|||||||0.1|||||||Skillings-Mack test|||||||0.10
73898761|NCT02984943|147329090|OTHER|||||||0.1|||||||Skillings-Mack test|||||||0.10
73898762|NCT02984943|147329091|OTHER|||||||0.02|||||||Skillings-Mack test|||||||0.02
73898763|NCT02984943|147329092|OTHER|||||||0.02|||||||Skillings-Mack test|||||||0.02
73898764|NCT02984943|147329093|OTHER|||||||0.004|||||||Skillings-Mack test|||||||0.004
73898765|NCT02984943|147329094|OTHER|||||||0.004|||||||Skillings-Mack test|||||||0.004
73898766|NCT02984943|147329095|OTHER|||||||0.2938|||||||Skillings-Mack test|||||||0.2938
73898767|NCT02984943|147329096|OTHER|||||||0.2938|||||||Skillings-Mack test|||||||0.2938
73898768|NCT02984943|147329097|OTHER|||||||0.0608|||||||Skillings-Mack test|||||||0.0608
73898769|NCT02984943|147329098|OTHER|||||||0.0608|||||||Skillings-Mack test|||||||0.0608
73898770|NCT02984943|147329099|OTHER|||||||0.1496|||||||Skillings-Mack test|||||||0.1496
73898771|NCT02984943|147329100|OTHER|||||||0.1496|||||||Skillings-Mack test|||||||0.1496
73898772|NCT02984943|147329101|OTHER|||||||0.36|||||||Skillings-Mack test|||||||0.36
73898773|NCT02984943|147329102|OTHER|||||||0.36|||||||Skillings-Mack test|||||||0.36
73898774|NCT02984943|147329103|OTHER|||||||0.0012|||||||Skillings-Mack test|||||||0.0012
73898775|NCT02984943|147329104|OTHER|||||||0.0012|||||||Skillings-Mack test|||||||0.0012
73898776|NCT02984943|147329105|OTHER|||||||0.9|||||||Skillings-Mack test|||||||0.90
73898777|NCT02984943|147329106|OTHER|||||||0.9|||||||Skillings-Mack test|||||||0.90
73898778|NCT02984943|147329107|OTHER|||||||0.0068|||||||Skillings-Mack test|||||||0.0068
74022498|NCT01355289|147597336|SUPERIORITY_OR_OTHER||Difference in % of Responders|60.78||||0.0003|TWO_SIDED|95.0|36.3|85.27|||Cochran-Mantel-Haenszel|||||85.27|36.30|0.0003
74022499|NCT01355289|147597336|SUPERIORITY_OR_OTHER||Difference in % of Responders|58.4||||0.0003|TWO_SIDED|95.0|30.92|85.88|||Cochran-Mantel-Haenszel|||||85.88|30.92|0.0003
73898779|NCT02984943|147329108|OTHER|||||||0.0068|||||||Skillings-Mack test|||||||0.0068
73898780|NCT02984943|147329109|OTHER|||||||0.0183|||||||Skillings-Mack test|||||||0.0183
73898781|NCT02984943|147329110|OTHER|||||||0.0183|||||||Skillings-Mack test|||||||0.0183
73898782|NCT02984943|147329111|OTHER|||||||0.08|||||||Skillings-Mack test|||||||0.08
73898783|NCT02984943|147329112|OTHER|||||||0.08|||||||Skillings-Mack test|||||||0.08
73898784|NCT02984943|147329113|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898785|NCT02984943|147329114|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898786|NCT02984943|147329115|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898787|NCT02984943|147329116|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898788|NCT02984943|147329117|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898789|NCT02984943|147329118|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898790|NCT02984943|147329119|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898791|NCT02984943|147329121|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898792|NCT02984943|147329122|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898793|NCT02984943|147329123|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898794|NCT02984943|147329125|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898795|NCT02984943|147329126|OTHER||||||||||||||||||Descriptive statistics only were used|||
73959985|NCT00762619|147455309|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898796|NCT02984943|147329127|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898797|NCT02984943|147329128|OTHER||||||||||||||||||Descriptive statistics only were used|||
73898798|NCT04575597|147329133|OTHER|Difference in rates % and associated confidence intervals (CIs) were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-4.1|||||TWO_SIDED|95.0|-12.2|2.5||||||||2.5|-12.2|
73898799|NCT04575597|147329133|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-1.5|||||TWO_SIDED|95.0|-9.9|6.2||||||||6.2|-9.9|
73898800|NCT04575597|147329133|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Differences in Rates %|-1.3|||||TWO_SIDED|95.0|-9.6|6.4||||||||6.4|-9.6|
73898801|NCT04575597|147329133|SUPERIORITY|Difference in rates %, associated CIs, and p-value were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-6.8||||0.0012|TWO_SIDED|95.0|-11.3|-2.4|||Miettinen & Nurminen|||||-2.4|-11.3|0.0012
73898802|NCT04575597|147329136|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.48|1.13||||||||1.13|0.48|
73898803|NCT04575597|147329136|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.46|1.08||||||||1.08|0.46|
73898804|NCT04575597|147329136|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.47|1.11||||||||1.11|0.47|
73898805|NCT04575597|147329136|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.92|1.18||||||||1.18|0.92|
73898806|NCT04575597|147329137|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.8|2.76||||||||2.76|0.80|
73898807|NCT04575597|147329137|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.69|2.09||||||||2.09|0.69|
73898808|NCT04575597|147329137|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.54|1.62||||||||1.62|0.54|
73898809|NCT04575597|147329137|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.95|1.33||||||||1.33|0.95|
73898810|NCT04575597|147329138|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.62|1.46||||||||1.46|0.62|
73898811|NCT04575597|147329138|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.75|1.79||||||||1.79|0.75|
73898812|NCT04575597|147329138|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.45|1.07||||||||1.07|0.45|
73898813|NCT04575597|147329138|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.93|1.23||||||||1.23|0.93|
73898814|NCT04575597|147329139|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.62|1.83||||||||1.83|0.62|
73898815|NCT04575597|147329139|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.4|1.26||||||||1.26|0.40|
73959986|NCT00762619|147455310|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959987|NCT00762619|147455311|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74022500|NCT01053312|147597348|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.688||||0.098|TWO_SIDED||||||Regression, Linear|||Contralateral to the biopsy Site||||0.098
73846009|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.2948|TWO_SIDED|95.0|-5.4|1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||1.6|-5.4|0.2948
73846010|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.0001|TWO_SIDED|95.0|-16.2|-9.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-9.1|-16.2|<0.0001
73846011|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.16|||<|0.0001|TWO_SIDED|95.0|-16.9|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-9.5|-16.9|<0.0001
73846012|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.213|TWO_SIDED|95.0|-6.0|1.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||1.3|-6.0|0.2130
73846013|NCT00565409|147238468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.83|||<|0.0001|TWO_SIDED|95.0|-14.5|-7.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-7.1|-14.5|<0.0001
73846014|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|||<|0.0001|TWO_SIDED|95.0|-11.8|-5.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-5.3|-11.8|<0.0001
73846015|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8033|TWO_SIDED|95.0|-3.6|2.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||2.8|-3.6|0.8033
73898816|NCT04575597|147329139|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.2|0.85||||||||0.85|0.20|
73898817|NCT04575597|147329139|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.86|1.18||||||||1.18|0.86|
73898818|NCT04575597|147329140|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.32|1.34||||||||1.34|0.32|
73846016|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.14|||<|0.0001|TWO_SIDED|95.0|-11.3|-4.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-4.9|-11.3|<0.0001
73846017|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.61|||<|0.0001|TWO_SIDED|95.0|-17.2|-10.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-10.0|-17.2|<0.0001
73846018|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.783|TWO_SIDED|95.0|-4.1|3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||3.1|-4.1|0.7830
73846019|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.11|||<|0.0001|TWO_SIDED|95.0|-16.7|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-9.5|-16.7|<0.0001
73846020|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.53|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-8.9|-16.1|<0.0001
73846021|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.5732|TWO_SIDED|95.0|-4.6|2.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization|ANCOVA|||Week 56||2.5|-4.6|0.5732
73846022|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.5|||<|0.0001|TWO_SIDED|95.0|-15.1|-7.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-7.9|-15.1|<0.0001
73846023|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.88|||<|0.0001|TWO_SIDED|95.0|-17.6|-10.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-10.2|-17.6|<0.0001
73898819|NCT04575597|147329140|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.76|2.71||||||||2.71|0.76|
73898820|NCT04575597|147329140|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.39|1.42||||||||1.42|0.39|
73898821|NCT04575597|147329140|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.94|1.37||||||||1.37|0.94|
74022501|NCT01053312|147597348|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.482||||0.268|||||||Regression, Linear|||Ipsilateral to the biopsy Site||||0.268
73898822|NCT04575597|147329141|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.66|1.61||||||||1.61|0.66|
73898823|NCT04575597|147329141|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.83|2.09||||||||2.09|0.83|
73898824|NCT04575597|147329141|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.47|1.23||||||||1.23|0.47|
73898825|NCT04575597|147329141|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.88|1.16||||||||1.16|0.88|
73898826|NCT04575597|147329142|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.62|1.41||||||||1.41|0.62|
73898827|NCT04575597|147329142|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.7|1.69||||||||1.69|0.70|
73898828|NCT04575597|147329142|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.66|1.51||||||||1.51|0.66|
73898829|NCT04575597|147329142|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.01|1.31||||||||1.31|1.01|
73898830|NCT04575597|147329143|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.54|1.69||||||||1.69|0.54|
73898831|NCT04575597|147329143|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.61|2.0||||||||2.00|0.61|
73898832|NCT04575597|147329143|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.5|1.38||||||||1.38|0.50|
73898833|NCT04575597|147329143|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.9|1.21||||||||1.21|0.90|
73898834|NCT04575597|147329144|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|0.77|2.76||||||||2.76|0.77|
73898835|NCT04575597|147329144|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.76|||||TWO_SIDED|95.0|0.92|3.38||||||||3.38|0.92|
73959988|NCT00762619|147455312|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73959989|NCT00762619|147455313|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73898836|NCT04575597|147329144|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|0.81|2.86||||||||2.86|0.81|
73898837|NCT04575597|147329144|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.89|1.24||||||||1.24|0.89|
73898838|NCT04575597|147329145|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.81|2.2||||||||2.20|0.81|
73898839|NCT04575597|147329145|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.85|2.31||||||||2.31|0.85|
73898840|NCT04575597|147329145|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.57|1.65||||||||1.65|0.57|
73898841|NCT04575597|147329145|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.89|1.18||||||||1.18|0.89|
73898842|NCT04575597|147329146|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.36|1.91||||||||1.91|0.36|
73898843|NCT04575597|147329146|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.64|2.97||||||||2.97|0.64|
73898844|NCT04575597|147329146|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.37|2.02||||||||2.02|0.37|
73898845|NCT04575597|147329146|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.74|1.14||||||||1.14|0.74|
74022502|NCT01053312|147597348|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.685||||0.099|||||||Regression, Linear|||Composite Region||||0.099
73898846|NCT04575597|147329147|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.44|1.06||||||||1.06|0.44|
73898847|NCT04575597|147329148|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.06|0.67||||||||0.67|0.06|
73898848|NCT04575597|147329148|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.33|||||TWO_SIDED|95.0|0.13|0.83||||||||0.83|0.13|
73898849|NCT04575597|147329148|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.27|||||TWO_SIDED|95.0|0.09|0.79||||||||0.79|0.09|
73898850|NCT04575597|147329148|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36||||||||1.36|0.87|
73898851|NCT04575597|147329149|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.74|2.23||||||||2.23|0.74|
73898852|NCT04575597|147329149|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.45|1.8||||||||1.80|0.45|
73898853|NCT04575597|147329149|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.55|1.89||||||||1.89|0.55|
73898854|NCT04575597|147329149|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.37||||||||1.37|0.94|
73898855|NCT04575597|147329150|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.83|2.33||||||||2.33|0.83|
73898856|NCT04575597|147329150|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.5|1.48||||||||1.48|0.50|
73898857|NCT04575597|147329150|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.56|1.72||||||||1.72|0.56|
73898858|NCT04575597|147329150|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|1.01|1.43||||||||1.43|1.01|
73898859|NCT04575597|147329151|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.29|2.19||||||||2.19|0.29|
73898860|NCT04575597|147329151|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.34|2.44||||||||2.44|0.34|
73898861|NCT04575597|147329151|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.77|||||TWO_SIDED|95.0|0.74|4.23||||||||4.23|0.74|
73898862|NCT04575597|147329151|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.04||||||||1.04|0.67|
73898863|NCT04575597|147329152|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|2.52|||||TWO_SIDED|95.0|0.98|6.53||||||||6.53|0.98|
73898864|NCT04575597|147329152|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.23|2.52||||||||2.52|0.23|
73898865|NCT04575597|147329152|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.11|1.84||||||||1.84|0.11|
73898866|NCT04575597|147329152|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.66|1.16||||||||1.16|0.66|
73898867|NCT04575597|147329153|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.46|3.32||||||||3.32|0.46|
73898868|NCT04575597|147329153|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.54|3.74||||||||3.74|0.54|
73898869|NCT04575597|147329153|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.34|2.76||||||||2.76|0.34|
73898870|NCT04575597|147329153|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.66|1.1||||||||1.10|0.66|
73898871|NCT04575597|147329154|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.41|2.52||||||||2.52|0.41|
73846024|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||0.2972|TWO_SIDED|95.0|-5.6|1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||1.7|-5.6|0.2972
73846025|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.94|||<|0.0001|TWO_SIDED|95.0|-15.6|-8.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-8.3|-15.6|<0.0001
73846026|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.64|||<|0.0001|TWO_SIDED|95.0|-19.4|-11.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-11.8|-19.4|<0.0001
73846027|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.1477|TWO_SIDED|95.0|-6.6|1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||1.0|-6.6|0.1477
73846028|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.85|||<|0.0001|TWO_SIDED|95.0|-16.6|-9.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-9.0|-16.6|<0.0001
73846029|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.87|||<|0.0001|TWO_SIDED|95.0|-18.6|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-11.1|-18.6|<0.0001
73846030|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.1808|TWO_SIDED|95.0|-6.3|1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||1.2|-6.3|0.1808
73846031|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.31|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-8.5|-16.1|<0.0001
73846032|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|||<|0.0001|TWO_SIDED|95.0|-18.5|-10.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-10.9|-18.5|<0.0001
73846033|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44||||0.2077|TWO_SIDED|95.0|-6.2|1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||1.4|-6.2|0.2077
73846034|NCT00565409|147238471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.26|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-8.5|-16.1|<0.0001
73898872|NCT04575597|147329154|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.26|1.9||||||||1.90|0.26|
73898873|NCT04575597|147329154|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.51|3.0||||||||3.00|0.51|
73898874|NCT04575597|147329154|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
73898875|NCT04575597|147329155|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.36|1.75||||||||1.75|0.36|
73898876|NCT04575597|147329155|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.33|1.64||||||||1.64|0.33|
73846035|NCT00565409|147238472|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
73846036|NCT00565409|147238473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8974|TWO_SIDED|95.0|0.5|2.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.5|0.5|0.8974
73846037|NCT00565409|147238473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.1105|TWO_SIDED|95.0|0.8|3.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||3.7|0.8|0.1105
73846038|NCT00565409|147238473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.19|TWO_SIDED|95.0|0.3|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.4|0.3|0.1900
73898877|NCT04575597|147329155|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.31|1.62||||||||1.62|0.31|
73898878|NCT04575597|147329155|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.76|1.16||||||||1.16|0.76|
73898879|NCT04575597|147329156|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.25|1.39||||||||1.39|0.25|
74084359|NCT01067521|147721930|SUPERIORITY||Risk Ratio (RR)|0.736|STANDARD_ERROR_OF_MEAN|0.081||0.0056|TWO_SIDED|95.0|0.592|0.914||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 6 Negative binomial regression||0.914|0.592|0.0056
73846039|NCT00565409|147238473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.18|||<|0.0001|TWO_SIDED|95.0|2.3|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||7.5|2.3|<0.0001
73846040|NCT00565409|147238473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.4032|TWO_SIDED|95.0|0.6|2.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.4|0.6|0.4032
73846041|NCT00565409|147238473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.4|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||7.5|2.4|<0.0001
73846042|NCT00565409|147238473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.0001|TWO_SIDED|95.0|2.1|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.2|2.1|<0.0001
73846043|NCT00565409|147238473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.0272|TWO_SIDED|95.0|1.0|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||3.6|1.0|0.0272
73846044|NCT00565409|147238473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.0004|TWO_SIDED|95.0|1.4|4.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.0|1.4|0.0004
73846045|NCT00565409|147238474|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
73846046|NCT00565409|147238474|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
73846047|NCT00565409|147238474|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
73846048|NCT00565409|147238474|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
73846049|NCT00565409|147238474|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
73846050|NCT00565409|147238474|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
73846051|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29||||0.1718|TWO_SIDED|95.0|0.5|10.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||10.7|0.5|0.1718
73846052|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8303|TWO_SIDED|95.0|0.2|7.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||7.3|0.2|0.8303
73846053|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27||||0.213|TWO_SIDED|95.0|0.5|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||10.1|0.5|0.2130
73846054|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.1|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||8.2|2.1|<0.0001
73846055|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.4337|TWO_SIDED|95.0|0.3|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||2.0|0.3|0.4337
73846056|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.14|||<|0.0001|TWO_SIDED|95.0|2.5|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||10.8|2.5|<0.0001
73846057|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.61|||<|0.0001|TWO_SIDED|95.0|3.0|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||10.5|3.0|<0.0001
73846058|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.8973|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.9|0.4|0.8973
73846059|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.33|||<|0.0001|TWO_SIDED|95.0|2.8|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||10.1|2.8|<0.0001
73846060|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.4|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||8.1|2.4|<0.0001
73846061|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5708|TWO_SIDED|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.7|0.4|0.5708
73846062|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58|||<|0.0001|TWO_SIDED|95.0|3.0|10.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||10.3|3.0|<0.0001
73846063|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.29|||<|0.0001|TWO_SIDED|95.0|3.3|12.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||12.0|3.3|<0.0001
73846064|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.8842|TWO_SIDED|95.0|0.4|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.0|0.4|0.8842
74022503|NCT02207907|147597417|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.491|||<|0.0001|TWO_SIDED|95.0|-20.317|-14.664|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-14.664|-20.317|<0.0001
74084360|NCT01067521|147721930|SUPERIORITY||Risk Ratio (RR)|0.633|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|0.524|0.765||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12 Negative binomial regression||0.765|0.524|<0.0001
73846065|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.92|||<|0.0001|TWO_SIDED|95.0|3.2|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||10.8|3.2|<0.0001
73846066|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.39|||<|0.0001|TWO_SIDED|95.0|3.8|14.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||14.4|3.8|<0.0001
73846067|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.1608|TWO_SIDED|95.0|0.6|3.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||3.1|0.6|0.1608
73846068|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.92|||<|0.0001|TWO_SIDED|95.0|2.9|8.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||8.4|2.9|<0.0001
73846069|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.44|||<|0.0001|TWO_SIDED|95.0|3.4|12.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||12.4|3.4|<0.0001
73846070|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.2825|TWO_SIDED|95.0|0.6|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||2.7|0.6|0.2825
73846071|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|95.0|2.7|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.8|2.7|<0.0001
73846072|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.0001|TWO_SIDED|95.0|2.7|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||8.7|2.7|<0.0001
73846073|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.4471|TWO_SIDED|95.0|0.5|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||2.1|0.5|0.4471
73846074|NCT00565409|147238475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.5|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.0|2.5|<0.0001
73846075|NCT00565409|147238476|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
73846076|NCT00565409|147238476|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
73846077|NCT00565409|147238476|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
73846078|NCT00565409|147238476|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
73846079|NCT00565409|147238476|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
73846080|NCT00565409|147238476|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
73846081|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.6006|TWO_SIDED|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.6|0.4|0.6006
73846082|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.4967|TWO_SIDED|95.0|0.6|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.1|0.6|0.4967
73846083|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3648|TWO_SIDED|95.0|0.4|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.5|0.4|0.3648
73846084|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.0024|TWO_SIDED|95.0|1.2|3.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.2|1.2|0.0024
73846085|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.8308||95.0|0.6|||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.|0.6|0.8308
73846086|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.0008|TWO_SIDED|95.0|1.3|3.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.4|1.3|0.0008
73846087|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.25|||<|0.0001|TWO_SIDED|95.0|2.0|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||5.2|2.0|<0.0001
73846088|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7374|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.8|0.7|0.7374
73846089|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.8|1.9|<0.0001
73846090|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.8|1.9|<0.0001
74084361|NCT01067521|147721930|SUPERIORITY||Risk Ratio (RR)|0.666|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|0.557|0.797||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36 Negative binomial regression||0.797|0.557|<0.0001
73898880|NCT04575597|147329156|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.38|1.78||||||||1.78|0.38|
73898881|NCT04575597|147329156|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.25|1.39||||||||1.39|0.25|
73898882|NCT04575597|147329156|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.91|1.48||||||||1.48|0.91|
73898883|NCT04575597|147329157|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.26|1.34||||||||1.34|0.26|
73898884|NCT04575597|147329157|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.28|1.37||||||||1.37|0.28|
73898885|NCT04575597|147329157|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.38|1.74||||||||1.74|0.38|
73898886|NCT04575597|147329157|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.79|1.21||||||||1.21|0.79|
73898887|NCT04575597|147329158|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.47|3.02||||||||3.02|0.47|
73898888|NCT04575597|147329158|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.29|2.2||||||||2.20|0.29|
73898889|NCT04575597|147329158|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.32|2.45||||||||2.45|0.32|
73898890|NCT04575597|147329158|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.62|1.11||||||||1.11|0.62|
73898891|NCT04575597|147329159|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.3|2.27||||||||2.27|0.30|
73898892|NCT04575597|147329159|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.04|1.0||||||||1.00|0.04|
73898893|NCT04575597|147329159|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.23|1.91||||||||1.91|0.23|
73898894|NCT04575597|147329159|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.62|1.23||||||||1.23|0.62|
73898895|NCT04575597|147329160|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.28|1.2||||||||1.20|0.28|
73898896|NCT04575597|147329160|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.2|0.95||||||||0.95|0.20|
73898897|NCT04575597|147329160|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.43|1.59||||||||1.59|0.43|
73898898|NCT04575597|147329160|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.73|1.19||||||||1.19|0.73|
73898899|NCT04575597|147329161|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.35|2.11||||||||2.11|0.35|
73898900|NCT04575597|147329161|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.16|1.34||||||||1.34|0.16|
73898901|NCT04575597|147329161|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.5|2.79||||||||2.79|0.50|
73898902|NCT04575597|147329161|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.74|1.32||||||||1.32|0.74|
73898903|NCT04575597|147329162|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.06|15.54||||||||15.54|0.06|
73898904|NCT04575597|147329162|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.0|||||TWO_SIDED|95.0|0.0||NA = Upper limit not reached as no events were recorded||||||||0.00|
73898905|NCT04575597|147329162|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.06|15.99||||||||15.99|0.06|
73898906|NCT04575597|147329162|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.46|1.25||||||||1.25|0.46|
73898907|NCT04575597|147329163|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.58|3.83||||||||3.83|0.58|
73898908|NCT04575597|147329163|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.42|3.05||||||||3.05|0.42|
73898909|NCT04575597|147329163|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.57|3.93||||||||3.93|0.57|
73898910|NCT04575597|147329163|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.61|1.1||||||||1.10|0.61|
73898911|NCT04575597|147329164|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.11|1.21||||||||1.21|0.11|
73898912|NCT04575597|147329164|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.2|1.36||||||||1.36|0.20|
73898913|NCT04575597|147329164|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.29|1.89||||||||1.89|0.29|
73898914|NCT04575597|147329164|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.68|1.2||||||||1.20|0.68|
73898915|NCT04575597|147329165|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.09|1.33||||||||1.33|0.09|
73898916|NCT04575597|147329165|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.15||||||||2.15|0.30|
73898917|NCT04575597|147329165|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.18|1.48||||||||1.48|0.18|
73898918|NCT04575597|147329165|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.62|1.04||||||||1.04|0.62|
73898919|NCT04575597|147329166|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|3.04|||||TWO_SIDED|95.0|0.59|15.59||||||||15.59|0.59|
73898920|NCT04575597|147329166|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.29|6.16||||||||6.16|0.29|
73898921|NCT04575597|147329166|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.37|||||TWO_SIDED|95.0|0.09|1.44||||||||1.44|0.09|
73898922|NCT04575597|147329166|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.62|2.3||||||||2.30|0.62|
73898923|NCT04575597|147329167|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|3.67|||||TWO_SIDED|95.0|1.14|11.88||||||||11.88|1.14|
73898924|NCT04575597|147329167|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.34|3.98||||||||3.98|0.34|
73898925|NCT04575597|147329167|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.27|2.68||||||||2.68|0.27|
73898926|NCT04575597|147329167|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.52|||||TWO_SIDED|95.0|0.96|2.39||||||||2.39|0.96|
73898927|NCT04575597|147329168|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.82|3.45||||||||3.45|0.82|
73898928|NCT04575597|147329168|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.55|2.33||||||||2.33|0.55|
73898929|NCT04575597|147329168|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.27|1.29||||||||1.29|0.27|
74084362|NCT01067521|147721931|SUPERIORITY||Risk Ratio (RR)|0.556|STANDARD_ERROR_OF_MEAN|0.093||0.0005|TWO_SIDED|95.0|0.4|0.773||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Month 6||0.773|0.4|0.0005
73846091|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9599|TWO_SIDED|95.0|0.6|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.7|0.6|0.9599
74022504|NCT02207907|147597418|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.201|||<|0.0001|TWO_SIDED|95.0|-0.237|-0.165|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.165|-0.237|<0.0001
73846092|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.98|||<|0.0001|TWO_SIDED|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.6|1.9|<0.0001
73846093|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.3|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||5.7|2.3|<0.0001
73846094|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.4509|TWO_SIDED|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.0|0.8|0.4509
73898930|NCT04575597|147329168|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|1.14|2.2||||||||2.20|1.14|
73898931|NCT04575597|147329169|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.41|||||TWO_SIDED|95.0|0.73|2.73||||||||2.73|0.73|
73898932|NCT04575597|147329169|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.52|1.94||||||||1.94|0.52|
73898933|NCT04575597|147329169|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.34|1.32||||||||1.32|0.34|
73898934|NCT04575597|147329169|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|1.03|1.78||||||||1.78|1.03|
74022505|NCT02620020|147597432|SUPERIORITY||Least Squares (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3876|TWO_SIDED|95.0|-0.88|0.34||Nominal p-value|Mixed Models Analysis|||||0.34|-0.88|0.3876
73846095|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||4.6|1.9|<0.0001
73846096|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.6|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||7.0|2.6|<0.0001
73846097|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.3037|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||2.0|0.7|0.3037
73846098|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27|||<|0.0001|TWO_SIDED|95.0|2.1|5.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||5.1|2.1|<0.0001
73846099|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.7|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.2|2.7|<0.0001
73898935|NCT04575597|147329170|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.35|1.66||||||||1.66|0.35|
73898936|NCT04575597|147329170|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.38|1.79||||||||1.79|0.38|
73898937|NCT04575597|147329170|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.37|1.81||||||||1.81|0.37|
74022506|NCT02620020|147597432|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.018|TWO_SIDED|95.0|-1.32|-0.12||Nominal p-value|Mixed Models Analysis|||||-0.12|-1.32|0.0180
74022507|NCT02620020|147597432|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0288|TWO_SIDED|95.0|-1.26|-0.07||Nominal p-value|Mixed Models Analysis|||||-0.07|-1.26|0.0288
73846100|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.6076|TWO_SIDED|95.0|0.7|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.7|0.6076
73846101|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.8|||<|0.0001|TWO_SIDED|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.0|2.4|<0.0001
73846102|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|1.8|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.6|1.8|<0.0001
73898938|NCT04575597|147329170|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
73898939|NCT04575597|147329171|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-3.0|||||TWO_SIDED|95.0|-5.9|-0.1||||||||-0.1|-5.9|
73898940|NCT03207438|147329172|SUPERIORITY||Hazard Ratio (HR)|1.39|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|||Main effect of quetiapine vs. placebo||||<.001
73898941|NCT03207438|147329172|SUPERIORITY||Hazard Ratio (HR)|1.15|STANDARD_ERROR_OF_MEAN|0.1||0.18|TWO_SIDED||||||Regression, Cox|||Interaction - treatment condition x melancholia||||.18
73898942|NCT03207438|147329172|SUPERIORITY||Hazard Ratio (HR)|1.46|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo||||<.001
73898943|NCT03207438|147329172|SUPERIORITY||Hazard Ratio (HR)|1.17|STANDARD_ERROR_OF_MEAN|0.1||0.14|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia||||.14
73898944|NCT03207438|147329173|SUPERIORITY||Hazard Ratio (HR)|1.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|||Main effect of quetiapine vs. placebo||||<.001
73898945|NCT03207438|147329173|SUPERIORITY||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED||||||Regression, Cox|||Interaction - treatment condition x melancholia||||.17
73898946|NCT03207438|147329173|SUPERIORITY||Hazard Ratio (HR)|1.3|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo||||<.001
73898947|NCT03207438|147329173|SUPERIORITY||Hazard Ratio (HR)|1.18|STANDARD_ERROR_OF_MEAN|0.11||0.13|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia||||.13
73898948|NCT03207438|147329174|SUPERIORITY|||||||0.33|||||||Fisher's exact test|||Day 4 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup|An exact OR could not be estimated by R; the 95% confidence interval was 0.31 to infinity, p = .33.|||.33
73898949|NCT03207438|147329174|SUPERIORITY||Odds Ratio (OR)|1.3||||0.44|TWO_SIDED||||||Fisher's exact test||The exact limits of 95% confidence interval could not be estimated, it was reported as 0.40 to infinity.|Week 1 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup||||.44
73898950|NCT03207438|147329174|SUPERIORITY||Chi-squared|0.38||||0.73|TWO_SIDED||||||Chi-squared, Corrected|||Week 2 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.73
73898951|NCT03207438|147329174|SUPERIORITY||Chi-squared|1.5||||0.11|TWO_SIDED||||||Chi-squared, Corrected|||Week 4 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.11
73898952|NCT03207438|147329174|SUPERIORITY||Chi-squared|0.001||||0.5|TWO_SIDED||||||Chi-squared, Corrected||The actual estimated Chi-squared statistic was 6.35(10\^-31)|Week 6 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.50
73898953|NCT03207438|147329175|SUPERIORITY||Chi-squared|0.001||||0.5|TWO_SIDED||||||Chi-squared, Corrected||Estimated chi-squared statistic was 1.88(10\^-29).|Day 4 - chi-squared test comparing response rates between groups.||||.5
73898954|NCT03207438|147329175|SUPERIORITY||Chi-squared|3.3||||0.03|TWO_SIDED||||||Chi-squared, Corrected|||Week 1 - chi-squared test comparing response rates between groups.||||.03
73898955|NCT03207438|147329175|SUPERIORITY||Chi-squared|3.87||||0.02|TWO_SIDED||||||Chi-squared, Corrected|||Week 2 - chi-squared test comparing response rates between groups.||||.02
73898956|NCT03207438|147329175|SUPERIORITY||Chi-squared|0.62||||0.22|TWO_SIDED||||||Chi-squared, Corrected|||Week 4 - chi-squared test comparing response rates between groups.||||.22
73898957|NCT03207438|147329175|SUPERIORITY||Chi-squared|2.45||||0.059|TWO_SIDED||||||Chi-squared, Corrected|||Week 6 - chi-squared test comparing response rates between groups.||||.059
73898958|NCT01512667|147329176|NON_INFERIORITY_OR_EQUIVALENCE|Similarity will be concluded if the GMR (severe renal insufficiency / healthy) is contained within the interval \[0.40, 2.50\].|GMR|1.6|||||TWO_SIDED|90.0|1.15|2.23||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (severe renal insufficiency / healthy) and 90% confidence intervals.||2.23|1.15|
73898959|NCT01512667|147329177|SUPERIORITY_OR_OTHER||GMR|1.46|||||TWO_SIDED|90.0|1.18|1.81||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (severe renal insufficiency / healthy) and 90% confidence intervals.||1.81|1.18|
73959990|NCT01063517|147455314|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|80.0|0.62|1.03|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).||1.03|0.62|
73898960|NCT01607203|147329182|NON_INFERIORITY_OR_EQUIVALENCE|t -test||||||0.04|TWO_SIDED||||||Fisher Exact|||||||0.04
73959991|NCT01063517|147455315|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|80.0|0.51|1.08|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).||1.08|0.51|
73959992|NCT01063517|147455316|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|80.0|0.41|0.75|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).||0.75|0.41|
73846103|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.7837|TWO_SIDED|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.6|0.6|0.7837
73846104|NCT00565409|147238477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.7|2.0|<0.0001
73846105|NCT00565409|147238478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
73846106|NCT00565409|147238478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
73846107|NCT00565409|147238478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
73846108|NCT00565409|147238478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
73846109|NCT00565409|147238478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
73898961|NCT00445588|147329191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.4|TWO_SIDED|95.0|0.6|1.3||cox regression model was used to estimate the HR of death compared to NABTT historical control with same histology, adjusted for age, KPS, and surgical procedure|Regression, Cox|cox regression model used to estimate the HR of death compared to NABTT historical control same histology, adjusted for age, KPS, surgical procedure||The overall failure rate will be estimated by dividing the number of events (death) with the total exposure time in the study cohort. 95% confidence intervals and median time of survival will be calculated using standard methods.||1.3|0.6|0.4
73898962|NCT01587898|147329205|SUPERIORITY_OR_OTHER|||||||0.5888|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Hgb||||0.5888
74084363|NCT01067521|147721931|SUPERIORITY||Risk Ratio (RR)|0.514|STANDARD_ERROR_OF_MEAN|0.073|<|0.0001|TWO_SIDED|95.0|0.388|0.679||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12||0.679|0.388|<0.0001
73846110|NCT00565409|147238478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
73846111|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.5263|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.0|0.7|0.5263
73846112|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.1055|TWO_SIDED|95.0|0.9|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|0.9|0.1055
73846113|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.4348|TWO_SIDED|95.0|0.5|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.4|0.5|0.4348
73846114|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.0003|TWO_SIDED|95.0|1.4|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.3|1.4|0.0003
73846115|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5511|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.7|0.7|0.5511
73846116|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0013|TWO_SIDED|95.0|1.3|2.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||2.9|1.3|0.0013
74084364|NCT01067521|147721931|SUPERIORITY||Risk Ratio (RR)|0.663|STANDARD_ERROR_OF_MEAN|0.086||0.0015|TWO_SIDED|95.0|0.514|0.854||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36||0.854|0.514|0.0015
73846117|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.79|||<|0.0001|TWO_SIDED|95.0|1.8|4.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.3|1.8|<0.0001
73846118|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9225|TWO_SIDED|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.5|0.6|0.9225
73846119|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.0001|TWO_SIDED|95.0|1.9|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.5|1.9|<0.0001
73846120|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2|||<|0.0001|TWO_SIDED|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||6.6|2.7|<0.0001
73846121|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.2454|TWO_SIDED|95.0|0.9|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||2.0|0.9|0.2454
73846122|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.9|2.0|<0.0001
73846123|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||6.0|2.4|<0.0001
73846124|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4919|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.9|0.8|0.4919
73846125|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||4.9|2.0|<0.0001
73959993|NCT01063517|147455317|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||||TWO_SIDED|80.0|0.22|0.56|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).||0.56|0.22|
73959994|NCT00546871|147455374|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.067|||||ONE_SIDED|99.0||0.134||||||||0.134||
73959995|NCT01713946|147455395|SUPERIORITY||Odds Ratio (OR)|2.21||||0.008|TWO_SIDED|95.0|1.16|4.2|||Bonferroni-Holm|||||4.20|1.16|0.008
73846126|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||7.6|3.0|<0.0001
73846127|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0658|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||2.3|1.0|0.0658
73846128|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||4.7|2.0|<0.0001
73846129|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.32|||<|0.0001|TWO_SIDED|95.0|2.7|6.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.8|2.7|<0.0001
73846130|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.4014|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.8|0.4014
73846131|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.54|||<|0.0001|TWO_SIDED|95.0|2.3|5.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||5.5|2.3|<0.0001
73846132|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.0001|TWO_SIDED|95.0|2.9|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.2|2.9|<0.0001
73846133|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.2824|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.9|0.8|0.2824
73846134|NCT00565409|147238479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.5|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||5.9|2.5|<0.0001
73846135|NCT00565409|147238480|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
73846136|NCT00565409|147238480|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
73846137|NCT00565409|147238480|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
73846138|NCT00565409|147238480|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
73846139|NCT00565409|147238480|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
73846140|NCT00565409|147238480|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||week 36||||<0.0001
73846141|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0575|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|1.0|0.0575
73846142|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.063|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|1.0|0.0630
73846143|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.916|TWO_SIDED|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.6|0.7|0.9160
73846144|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.0147|TWO_SIDED|95.0|1.0|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.0|1.0|0.0147
73846145|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.8675|TWO_SIDED|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.6|0.6|0.8675
73846146|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0174|TWO_SIDED|95.0|1.1|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.0|1.1|0.0174
73846147|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.0001|TWO_SIDED|95.0|1.9|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||5.7|1.9|<0.0001
73846148|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.4941|TWO_SIDED|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.3|0.5|0.4941
73846149|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.3|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||7.0|2.3|<0.0001
73846150|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||<|0.0001|TWO_SIDED|95.0|2.0|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||5.9|2.0|<0.0001
73846151|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.8185|TWO_SIDED|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.5|0.6|0.8185
73846152|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.66|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||6.4|2.1|<0.0001
73846153|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.2|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||6.6|2.2|<0.0001
73846154|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4254|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.8|0.7|0.4254
73846155|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.38|||<|0.0001|TWO_SIDED|95.0|1.9|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||5.9|1.9|<0.0001
73846156|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.26|||<|0.0001|TWO_SIDED|95.0|1.8|5.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||5.8|1.8|<0.0001
73846157|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8766|TWO_SIDED|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||1.6|0.7|0.8766
73846158|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||6.4|2.1|<0.0001
73898963|NCT01587898|147329205|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Weight||||0.6600
73846159|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.0|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.4|2.0|<0.0001
73846160|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.3535|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.8|0.3535
73846161|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.0001|TWO_SIDED|95.0|1.9|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.1|1.9|<0.0001
73846162|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45|||<|0.0001|TWO_SIDED|95.0|2.0|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||6.1|2.0|<0.0001
73846163|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.3231|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.9|0.8|0.3231
73846164|NCT00565409|147238481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|1.9|5.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||5.6|1.9|<0.0001
73846165|NCT00565409|147238482|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
73898964|NCT01587898|147329205|SUPERIORITY_OR_OTHER|||||||0.7999|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline estimated glomerular filtration rate (eGFR)||||0.7999
73846166|NCT00565409|147238482|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
73846167|NCT00565409|147238482|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
73846168|NCT00565409|147238482|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
73846169|NCT00565409|147238482|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
73846170|NCT00565409|147238482|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
73846171|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14||||0.0089|TWO_SIDED|95.0|0.9|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||5.2|0.9|0.0089
73846172|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.6932|TWO_SIDED|95.0|0.5|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.7|0.5|0.6932
73846173|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.76||||0.0019|TWO_SIDED|95.0|1.2|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||6.1|1.2|0.0019
73846174|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.0797|TWO_SIDED|95.0|0.6|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.6|0.6|0.0797
73846175|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8103|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.9|0.4|0.8103
73846176|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.0903|TWO_SIDED|95.0|0.8|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||4.5|0.8|0.0903
73846177|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.0035|TWO_SIDED|95.0|1.2|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||7.8|1.2|0.0035
73846178|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.977|TWO_SIDED|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||2.0|0.5|0.9770
73846179|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29||||0.0036|TWO_SIDED|95.0|1.3|8.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||8.3|1.3|0.0036
73846180|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8||||0.0038|TWO_SIDED|95.0|1.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||7.7|1.0|0.0038
73846181|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9055|TWO_SIDED|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||2.0|0.5|0.9055
73846182|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36||||0.002|TWO_SIDED|95.0|1.2|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||9.8|1.2|0.0020
73846183|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.35||||0.002|TWO_SIDED|95.0|1.3|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||8.8|1.3|0.0020
73846184|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.5763|TWO_SIDED|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.7|0.4|0.5763
73846185|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93||||0.0002|TWO_SIDED|95.0|1.5|10.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||10.0|1.5|0.0002
73846186|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21||||0.0004|TWO_SIDED|95.0|1.2|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||8.8|1.2|0.0004
73846187|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.4828|TWO_SIDED|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||1.6|0.4|0.4828
73846188|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|1.4|9.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||9.0|1.4|<0.0001
73846189|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28||||0.0002|TWO_SIDED|95.0|1.4|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.8|1.4|0.0002
73846190|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8553|TWO_SIDED|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.6|0.8553
73846191|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56||||0.0003|TWO_SIDED|95.0|1.5|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||8.7|1.5|0.0003
73846192|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|1.6|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.6|1.6|<0.0001
73846193|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.5025|TWO_SIDED|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||2.0|0.6|0.5025
73959996|NCT01713946|147455395|SUPERIORITY||Odds Ratio (OR)|3.93|||<|0.001|TWO_SIDED|95.0|2.1|7.32|||Bonferroni-Holm|||||7.32|2.10|<0.001
73959997|NCT01713946|147455396|SUPERIORITY||Median Difference (Final Values)|15.96||||0.003|TWO_SIDED|95.0|1.98|31.68|||Bonferroni-Holm|||||31.68|1.98|0.003
73846194|NCT00565409|147238483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.62||||0.0001|TWO_SIDED|95.0|1.6|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||8.1|1.6|0.0001
73846195|NCT02347605|147238508|SUPERIORITY|||||||0.25||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis|||||||0.25
73846196|NCT02347605|147238509|SUPERIORITY|||||||0.18||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis|||||||0.18
73846197|NCT01991860|147238515|SUPERIORITY|||||||0.033||||||2-sided|Chi-squared, Corrected|Yates's continuity correction||||||0.033
73846198|NCT01991860|147238516|SUPERIORITY|||||||0.16|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.16
73846199|NCT01991860|147238517|SUPERIORITY|||||||0.68|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.68
73846200|NCT01991860|147238518|SUPERIORITY|||||||0.026|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.026
73846201|NCT01991860|147238519|SUPERIORITY|||||||0.086|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.086
73959998|NCT01713946|147455396|SUPERIORITY||Odds Ratio (OR)|27.46|||<|0.001|TWO_SIDED|95.0|16.36|43.36|||Bonferroni-Holm|||||43.36|16.36|<0.001
73959999|NCT01713946|147455397|SUPERIORITY||Odds Ratio (OR)|6.55|||||TWO_SIDED|95.0|0.77|55.73||||||||55.73|0.77|
73960000|NCT01713946|147455397|SUPERIORITY||Odds Ratio (OR)|4.99|||||TWO_SIDED|95.0|0.57|44.03||||||||44.03|0.57|
74084365|NCT01067521|147721932|SUPERIORITY||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.041||0.0425|TWO_SIDED|95.0|-0.166|-0.003||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 6||-0.003|-0.166|0.0425
73846202|NCT01991860|147238520|SUPERIORITY|||||||0.074|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.074
73846203|NCT01991860|147238521|SUPERIORITY|||||||0.15|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.15
73846204|NCT00518180|147238531|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-2.0|||||TWO_SIDED|95.0|-6.0|3.0||||||Immune response to Men A when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||3|-6|
73846205|NCT00518180|147238531|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||TWO_SIDED|95.0|-6.0|3.0||||||Immune response to Men C when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||3|-6|
73846206|NCT00518180|147238531|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||TWO_SIDED|95.0|-9.0|1.0||||||Immune response to Men W when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-9|
73846207|NCT00518180|147238531|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|0.0|||||TWO_SIDED|95.0|-4.0|5.0||||||Immune response to Men Y when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||5|-4|
73846208|NCT00518180|147238531|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|5.0|||||TWO_SIDED|95.0|1.0|10.0||||||Immune response to Men A when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||10|1|
73898965|NCT01587898|147329205|SUPERIORITY_OR_OTHER|||||||0.2092|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Ethnicity||||0.2092
73898966|NCT01587898|147329205|SUPERIORITY_OR_OTHER|||||||0.9996||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Geographic Ancestry||||0.9996
73898967|NCT01587898|147329205|SUPERIORITY_OR_OTHER|||||||0.7002|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Sex||||0.7002
73898968|NCT01587898|147329205|SUPERIORITY_OR_OTHER|||||||0.5536||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Age||||0.5536
73898969|NCT01587898|147329205|SUPERIORITY_OR_OTHER|||||||0.0085||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Co-administration with food||||0.0085
73898970|NCT01587898|147329205|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Diabetic||||0.0021
73898971|NCT01587898|147329205|SUPERIORITY_OR_OTHER|||||||0.2194||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Region||||0.2194
73898972|NCT01738477|147329248|NON_INFERIORITY|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-diphtheria. Objective of non-inferiority was considered to be met if the lower limit (LL) of the 95% confidence interval (CI) was greater than, or equal to -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to diphtheria.||9.95|-3.25|
73898973|NCT01738477|147329248|NON_INFERIORITY|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-tetanus. Objective of non-inferiority was considered to be met if the LL of the 95% CI was above -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to tetanus.||9.95|-3.25|
73960001|NCT01713946|147455398|SUPERIORITY||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.05|2.97||||||||2.97|1.05|
73960002|NCT01713946|147455398|SUPERIORITY||Odds Ratio (OR)|3.82|||||TWO_SIDED|95.0|2.25|6.48||||||||6.48|2.25|
74084366|NCT01067521|147721932|SUPERIORITY||Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.05||0.0844|TWO_SIDED|95.0|-0.184|0.012||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 12||0.012|-0.184|0.0844
74084367|NCT01067521|147721932|SUPERIORITY||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.106||0.8701|TWO_SIDED|95.0|-0.91|0.225||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 36||0.225|-0.91|0.8701
73846209|NCT00518180|147238531|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||||||Immune response to Men C when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||4|-6|
73846210|NCT00518180|147238531|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-16.0|||||TWO_SIDED|95.0|-21.0|-10.0||||||Immune response to Men W when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||-10|-21|
73846211|NCT00518180|147238531|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||TWO_SIDED|95.0|-9.0|1.0||||||Immune response to Men Y when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-9|
73846212|NCT00518180|147238532|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL \[Group I minus Group III\] were greater than -10%.|Vaccine Group differences (%)|2.0|||||TWO_SIDED|95.0|1.0|4.0||||||Non inferiority of the immune response to diphteria antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||4|1|
73846213|NCT00518180|147238532|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL \[Group I minus Group III\] were greater than -10%.|Vaccine Group differences (%)|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Non inferiority of the immune response to tetanus antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-1|
73846214|NCT00518180|147238541|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9||||||Non inferiority of the immune response to Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PT antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.9|0.72|
73846215|NCT00518180|147238541|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.68|||||TWO_SIDED|95.0|0.58|0.81||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PRN antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.81|0.58|
73846216|NCT00518180|147238541|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.67|||||TWO_SIDED|95.0|0.58|0.76||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alon, for FHA antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.76|0.58|
73846217|NCT00485173|147238552|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
73846218|NCT00485173|147238552|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||<0.001
73846219|NCT00485173|147238553|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
73846220|NCT00485173|147238553|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.002
73846221|NCT00485173|147238554|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.002
73960003|NCT01713946|147455400|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-0.4|3.1||||||||3.1|-0.4|
73846222|NCT00485173|147238555|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random sampling, based on covariance matrix produced by logistic regression using propensity score as a covariate.|Regression, Logistic|||||||<0.001
73846223|NCT00485173|147238555|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.011
73846224|NCT00485173|147238556|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.063
73846225|NCT00485173|147238557|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
73846226|NCT00485173|147238557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||<0.001
73846227|NCT00485173|147238558|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.031
73846228|NCT00485173|147238559|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.||||||0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||0.001
73846229|NCT00485173|147238559|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.414
73846230|NCT00485173|147238560|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.030
73846231|NCT00485173|147238561|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
73846232|NCT00485173|147238561|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.017
73960004|NCT01713946|147455400|SUPERIORITY||Mean Difference (Final Values)|4.2|||||TWO_SIDED|95.0|2.5|5.9||||||||5.9|2.5|
73846233|NCT00485173|147238562|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.189
73846234|NCT00485173|147238563|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.||||||0.003||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||0.003
73846235|NCT00485173|147238563|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.466
73846236|NCT00485173|147238564|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
73846237|NCT00485173|147238564|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.133
73846238|NCT00485173|147238565|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||<0.001
73846239|NCT00485173|147238566|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||<0.001
73846240|NCT00485173|147238567|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.341
73846241|NCT00485173|147238568|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||P-value was two-sided, obtained from Cox regression and adjusted with propensity scores.|Regression, Cox|||||||0.479
73846242|NCT00485173|147238569|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was from logistic regression model by using propensity score and any ossification 'Yes/No' at preop as the covariates.|Regression, Logistic|||Statistical analysis at 24 months postoperation.||||<0.001
73846243|NCT00829244|147238570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.8||0.037|TWO_SIDED|95.0|-3.3|-0.1|||ANOVA|||The null hypothesis was that the difference between the mean number of oocytes \[CONSORT calculator dosing - Standard dosing\] was less than or equal to \[=\<\] (-3). The alternate hypothesis was that the difference was greater than \[\>\] (-3).||-0.1|-3.3|0.037
73846244|NCT00829244|147238571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-511.37|STANDARD_ERROR_OF_MEAN|64.52|<|0.001|TWO_SIDED|95.0|-638.78|-383.96|||ANOVA|||||-383.96|-638.78|<0.001
73846245|NCT00829244|147238572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.6|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-53.75|-37.46|||ANOVA|||||-37.46|-53.75|<0.001
73846246|NCT00829244|147238573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.933|TWO_SIDED|95.0|-0.4|0.5|||ANOVA|||||0.5|-0.4|0.933
73846247|NCT00829244|147238575|SUPERIORITY_OR_OTHER||Percent difference|3.6|||||TWO_SIDED|95.0|-11.0|18.2||||||||18.2|-11.0|
73846248|NCT00829244|147238577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|6.6||0.926|TWO_SIDED|95.0|-12.3|13.6|||ANOVA|||||13.6|-12.3|0.926
73846249|NCT00829244|147238579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.78||0.235|TWO_SIDED|95.0|-0.61|2.47|||ANOVA|||||2.47|-0.61|0.235
73846250|NCT00829244|147238580|SUPERIORITY_OR_OTHER||Percent difference|0.6|||||TWO_SIDED|95.0|-13.5|14.6||||||||14.6|-13.5|
73960005|NCT01713946|147455401|SUPERIORITY||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.77|2.07||||||||2.07|0.77|
73960006|NCT01713946|147455401|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.74|1.96||||||||1.96|0.74|
73846251|NCT02297412|147238594|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0186|||||||Wilcoxon (Mann-Whitney)|||||||0.0186
73846252|NCT02297412|147238595|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1146|||||||Wilcoxon (Mann-Whitney)|||||||0.1146
73846253|NCT02297412|147238596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0243|||||||Wilcoxon (Mann-Whitney)|||||||0.0243
73846254|NCT02031302|147238597|OTHER|One-sided Clopper-Pearson 98.699% upper bound|||||<|0.0001||||||The proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure.|Chi-squared|||Note: the 95% CI is from Clopper-Pearson Exact Method. The analysis was only done for the Lotus valve arm as the Lotus with Depth Guard arm has not sufficient power for this statistical analysis.|One-sided Clopper-Pearson 98.699% upper bound: 4.11% Performance goal is 14%|||<.0001
73846255|NCT04712669|147238625|SUPERIORITY||Mean Difference (Final Values)|57.27|STANDARD_ERROR_OF_MEAN|24.773||0.0208|TWO_SIDED|95.0|8.716|105.824||LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.|ANCOVA|H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.||||105.824|8.716|0.0208
73846256|NCT04712669|147238625|SUPERIORITY||Mean Difference (Final Values)|58.406|STANDARD_ERROR_OF_MEAN|24.558||0.0174|TWO_SIDED|95.0|10.272|106.54||LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.|ANCOVA|H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.||||106.54|10.272|0.0174
73846257|NCT04712669|147238626|SUPERIORITY|||||||0.573||||||P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.|Regression, Logistic|H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.||||||0.573
73846258|NCT04712669|147238626|SUPERIORITY|||||||0.9911||||||P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.|Regression, Logistic|H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.||||||0.9911
73846259|NCT04712669|147238627|SUPERIORITY||Median Difference (Final Values)|-33.61|STANDARD_ERROR_OF_MEAN|18.121||0.0636|TWO_SIDED|95.0|-69.13|1.91||p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.|Wilcoxon (Mann-Whitney)|H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.||||1.91|-69.13|0.0636
73846260|NCT04712669|147238627|SUPERIORITY||Median Difference (Final Values)|-19.05|STANDARD_ERROR_OF_MEAN|13.469||0.1573|TWO_SIDED|95.0|-45.45|7.35||p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.|Wilcoxon (Mann-Whitney)|H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.||||7.35|-45.45|0.1573
73846261|NCT04712669|147238628|SUPERIORITY||Mean Difference (Final Values)|1125.9|STANDARD_ERROR_OF_MEAN|351.28||0.0014|TWO_SIDED|95.0|437.39|1814.39|||Mixed Models Analysis|H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.|Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.|||1814.39|437.39|0.0014
73846262|NCT04712669|147238628|SUPERIORITY||Mean Difference (Final Values)|866.3|STANDARD_ERROR_OF_MEAN|306.56||0.0047|TWO_SIDED|95.0|265.41|1467.16|||Mixed Models Analysis|H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.|Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.|||1467.16|265.41|0.0047
73846263|NCT03802396|147238629|OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
73846264|NCT03802396|147238630|OTHER|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.116
73846265|NCT03802396|147238630|OTHER|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.388
73846266|NCT03802396|147238631|OTHER|||||||0.569|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.569
73846267|NCT03802396|147238631|OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.047
73846268|NCT03802396|147238632|OTHER|||||||0.498|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.498
73846269|NCT03802396|147238632|OTHER|||||||0.745|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.745
73898974|NCT01227824|147329268|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG - RAL) in percentages between the two treatment arms was \> -10%.|Difference in percentage|2.5|||||TWO_SIDED|95.0|-2.2|7.1|||||Analysis was based on Cochran-Mantel Haenszel stratified analysis adjusted for the following Baseline stratification factors: baseline HIV-1 RNA and background dual NRTI.|||7.1|-2.2|
73846270|NCT03802396|147238633|OTHER|||||||0.177|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.177
73960007|NCT01713946|147455402|SUPERIORITY||Difference in least square means|-1.1|||||TWO_SIDED|95.0|-4.4|2.1||||||||2.1|-4.4|
73846271|NCT03802396|147238633|OTHER|||||||0.478|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.478
73846272|NCT03802396|147238634|OTHER|||||||0.803|||||||t-test, 2 sided|||||||0.803
73846273|NCT03802396|147238636|OTHER||Risk Ratio (RR)|0.73||||0.286|TWO_SIDED|95.0|0.41|1.3|||Chi-squared|||||1.30|0.41|0.286
73846274|NCT03802396|147238637|OTHER|||||||0.189|||||||Wilcoxon (Mann-Whitney)|||||||0.189
73846275|NCT00163293|147238638|SUPERIORITY_OR_OTHER|||||||0.6625||95.0|||||Log Rank|||||||0.6625
73846276|NCT00163293|147238638|SUPERIORITY_OR_OTHER|||||||0.7303||95.0|||||Log Rank|||||||0.7303
73846277|NCT00163293|147238639|SUPERIORITY_OR_OTHER|||||||0.1291||95.0|||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age \[yrs\] (zero model), treatment and race (Poisson model)||||||0.1291
73846278|NCT00163293|147238639|SUPERIORITY_OR_OTHER|||||||0.0145||95.0|||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age \[yrs\] (zero model), treatment and race (Poisson model)||||||0.0145
73846279|NCT00163293|147238641|SUPERIORITY_OR_OTHER|||||||0.4754|||||||Kruskal-Wallis|||||||0.4754
73846280|NCT00163293|147238641|SUPERIORITY_OR_OTHER|||||||0.6844|||||||Kruskal-Wallis|||||||0.6844
73960008|NCT01713946|147455402|SUPERIORITY||Difference in least square means|1.0|||||TWO_SIDED|95.0|-2.2|4.3||||||||4.3|-2.2|
73960009|NCT01713946|147455403|SUPERIORITY||Difference in least square means|-2.1|||||TWO_SIDED|95.0|-10.5|6.2||||||||6.2|-10.5|
73898975|NCT02660138|147329296|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025.|LS Mean Difference|-10.83||||0.0001|TWO_SIDED|95.0|-16.36|-5.31|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-5.31|-16.36|0.0001
73898976|NCT02660138|147329296|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025.|LS Mean Difference|-12.19|||<|0.0001|TWO_SIDED|95.0|-17.65|-6.73|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-6.73|-17.65|<0.0001
73898977|NCT02660138|147329297|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|160.9|||<|0.0001|TWO_SIDED|95.0|109.9|211.9|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||211.9|109.9|<0.0001
73898978|NCT02660138|147329297|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|189.2|||<|0.0001|TWO_SIDED|95.0|140.1|238.2|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||238.2|140.1|<0.0001
73898979|NCT02660138|147329298|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|-24.3|||<|0.0001|TWO_SIDED|95.0|-32.3|-16.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-16.4|-32.3|<0.0001
73898980|NCT02660138|147329298|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-36.2|-21.1|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-21.1|-36.2|<0.0001
73898981|NCT02660138|147329299|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|155.5|||<|0.0001|TWO_SIDED|95.0|100.5|210.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||210.4|100.5|<0.0001
73898982|NCT02660138|147329299|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|181.8|||<|0.0001|TWO_SIDED|95.0|129.2|234.3|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||234.3|129.2|<0.0001
73898983|NCT02660138|147329300|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|9.83||||0.0006|TWO_SIDED|95.0|2.72|35.6|||Generalised linear mixed model (GLMM)|||Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||35.60|2.72|0.0006
73898984|NCT02660138|147329300|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|10.99||||0.0003|TWO_SIDED|95.0|3.05|39.61|||GLMM|||Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||39.61|3.05|0.0003
73898985|NCT02660138|147329301|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|5.73||||0.001|TWO_SIDED|95.0|2.02|16.24|||Regression, Logistic|||Treatment group, and recorded stratification factors (aetiology of NDO, previous BTX-A usage) and study baseline (prior intradetrusor BTX-A usage for UI) as explanatory variables.||16.24|2.02|0.0010
73898986|NCT02660138|147329301|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|16.08|||<|0.0001|TWO_SIDED|95.0|5.82|44.43|||Regression, Logistic|||Treatment group, and recorded stratification factors (aetiology of NDO, previous BTX-A usage) and study baseline (prior intradetrusor BTX-A usage for UI) as explanatory variables.||44.43|5.82|<0.0001
73898987|NCT02660138|147329302|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|13.3||||0.0003|TWO_SIDED|95.0|6.22|20.37|||MMRM|||Treatment group, visit (Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (I-QoL summary total score) as fixed variables, and subject as a random effect.||20.37|6.22|0.0003
73898988|NCT02660138|147329302|SUPERIORITY|The secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|17.25|||<|0.0001|TWO_SIDED|95.0|10.36|24.15|||MMRM|||Treatment group, visit (Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (I-QoL summary total score) as fixed variables, and subject as a random effect.||24.15|10.36|<0.0001
74022508|NCT02620020|147597434|SUPERIORITY||LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.73||0.0028|TWO_SIDED|95.0|-3.65|-0.77||Nominal p-value|Mixed Models Analysis|||||-0.77|-3.65|0.0028
74022509|NCT02620020|147597434|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.72||0.0068|TWO_SIDED|95.0|-3.36|-0.54||Nominal p-value|Mixed Models Analysis|||||-0.54|-3.36|0.0068
74022510|NCT02620020|147597434|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.72||0.0006|TWO_SIDED|95.0|-3.88|-1.06||Nominal p-value|Mixed Models Analysis|||||-1.06|-3.88|0.0006
74022511|NCT02620020|147597435|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1501|TWO_SIDED|95.0|-0.46|0.07||Nominal p-value|Mixed Models Analysis|||||0.07|-0.46|0.1501
74022512|NCT02620020|147597435|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.2603|TWO_SIDED|95.0|-0.41|0.11||Nominal p-value|Mixed Models Analysis|||||0.11|-0.41|0.2603
74022513|NCT02620020|147597435|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0135|TWO_SIDED|95.0|-0.59|-0.07||Nominal p-value|Mixed Models Analysis|||||-0.07|-0.59|0.0135
73846281|NCT03366454|147238686|OTHER||AUC|0.6692|STANDARD_ERROR_OF_MEAN|0.05322||0.0048|TWO_SIDED|95.0|0.5649|0.7735|||ROC Curve Analysis|||ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)||0.7735|0.5649|0.0048
74022514|NCT00885079|147597465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for change from baseline in the FCS score was determined by comparing the non-inferiority margin (0.4) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Mean Difference (Final Values)|-0.9|STANDARD_DEVIATION|2.1|<|0.05|TWO_SIDED|95.0|-1.47|-0.24||An analysis of change from baseline of FCS was performed using t-test. The level of singnificanse was 5 % (2-sided).|t-test, 2 sided|||||-0.24|-1.47|<0.05
74022515|NCT00885079|147597466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||<|0.05|||||||t-test, 2 sided|||||||<0.05
74022516|NCT02630953|147597470|SUPERIORITY||Median Difference (Final Values)|-6.22||||0.24|TWO_SIDED|95.0|-41.15|28.7||Significance level was set at .05 a priori.|quantile regression|Bootstrapped standard errors (10,000 replications)||Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-ups, controlling for baseline. Quantile regression models the median outcome instead of the mean, and are appropriate when data is skewed (as was the case in both self-reported and objectively measured MVPA).||28.70|-41.15|0.24
74022517|NCT02630953|147597471|SUPERIORITY||Median Difference (Final Values)|7.5||||0.73|TWO_SIDED|95.0|-32.37|47.37||Significance was set at .05 a priori|quantile regression|||Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-up, controlling for baseline||47.37|-32.37|0.73
74022518|NCT02630953|147597472|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.035|>|0.06|TWO_SIDED|||||Significance level set at .05 a priori|Regression, Linear|||Using a series of generalized linear models with identity link, we examined treatment effects on biomarkers at 6 months controlling for baseline and potential confounders.||||>.06
73846282|NCT03366454|147238686|OTHER||AUC|0.6892|STANDARD_ERROR_OF_MEAN|0.05213||0.0029|TWO_SIDED|95.0|0.587|0.7914|||ROC Curve Analysis|||ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.7914|0.5870|0.0029
73846283|NCT03366454|147238687|OTHER||AUC|0.644|STANDARD_ERROR_OF_MEAN|0.05635||0.0233|TWO_SIDED|95.0|0.5335|0.7544|||ROC Curve Analysis||The optimal cutoff value for NLR was determined as 1.335 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.7544|0.5335|0.0233
73846284|NCT03366454|147238688|OTHER||AUC|0.6884|STANDARD_ERROR_OF_MEAN|0.04709||0.0018|TWO_SIDED|95.0|0.5962|0.7807|||ROC Curve Analysis||The optimal cut-off value for CRP was determined as 5.70 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)||0.7807|0.5962|0.0018
73846285|NCT03366454|147238689|OTHER||AUC|0.7063|STANDARD_ERROR_OF_MEAN|0.04857||0.0007|TWO_SIDED|95.0|0.6111|0.8015|||ROC Curve Analysis||The optimal cutoff value for PCT was determined as 0.141 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.8015|0.6111|0.0007
73846286|NCT01819272|147238695|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-9.0||||0.067|TWO_SIDED|95.0|-21.0|1.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||1.0|-21.0|0.0670
73846287|NCT01819272|147238695|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-14.0||||0.0057|TWO_SIDED|95.0|-22.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-4.0|-22.0|0.0057
73846288|NCT01819272|147238695|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-12.0||||0.1095|TWO_SIDED|95.0|-25.0|3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||3.0|-25.0|0.1095
73846289|NCT01819272|147238695|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-12.0||||0.0097|TWO_SIDED|95.0|-23.0|-3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-3.0|-23.0|0.0097
74022519|NCT00700804|147597507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|STANDARD_DEVIATION|2.5||0.05|||||||Mixed Models Analysis|Effects of calcium (Ca), protein \& their interaction were tested using repeated measures analysis of variance (subjects nested under High or Low Ca)|Reported analysis is the main effect of Calcium (High vs Low) from the Mixed Model Analysis which averages across the two levels of dietary protein. The main effect of protein and the calcium x protein interaction were not statistically significant.|||||0.05
74022520|NCT01707992|147597557|SUPERIORITY||Hazard Ratio (HR)|0.937|||=|0.7057|TWO_SIDED|95.0|0.668|1.313||Threshold for significance at 0.05 level.|Cox proportional hazards model|||The primary analysis for the comparison between laquinimod 0.6 mg versus placebo was conducted using the baseline adjusted Cox proportional hazards model. Categorical EDSS at baseline (less than or equal to \[\<=\] 4 or greater than \[\>\] 4), country/geographical region (CGR), categorical age at baseline (\<=38 or \>38), and T2 volume at baseline were included as covariates in the model.||1.313|0.668|= 0.7057
73898989|NCT02660138|147329303|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|4.0||||0.0007|TWO_SIDED|95.0|1.8|8.86||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 600 U versus Placebo.||8.86|1.80|0.0007
73898990|NCT02660138|147329303|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.63||||0.0012|TWO_SIDED|95.0|1.68|7.86||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 800 U versus Placebo||7.86|1.68|0.0012
73898991|NCT02660138|147329303|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|8.03|||<|0.0001|TWO_SIDED|95.0|3.56|18.09||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement Level: Dysport® 600 U versus Placebo.||18.09|3.56|<0.0001
73898992|NCT02660138|147329303|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|8.22|||<|0.0001|TWO_SIDED|95.0|3.66|18.47||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement Level: Dysport® 800 U versus Placebo||18.47|3.66|<0.0001
73898993|NCT02660138|147329303|OTHER|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|10.7|||<|0.0001|TWO_SIDED|95.0|4.59|24.95||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement Level: Dysport® 600 U versus Placebo.||24.95|4.59|<0.0001
73898994|NCT02660138|147329303|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|12.63|||<|0.0001|TWO_SIDED|95.0|5.4|29.56||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement Level: Dysport® 800 U versus Placebo.||29.56|5.40|<0.0001
73898995|NCT02660138|147329304|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|84.81|||<|0.0001|TWO_SIDED|95.0|43.73|125.89|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||125.89|43.73|<0.0001
73898996|NCT02660138|147329304|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|110.57|||<|0.0001|TWO_SIDED|95.0|70.17|150.98|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||150.98|70.17|<0.0001
73898997|NCT04876690|147329317|SUPERIORITY||||||=|0.1217|||||||t-test for Independent Samples|||PCS-12: Sex||||=0.1217
73898998|NCT04876690|147329317|SUPERIORITY||||||=|0.8241|||||||ANOVA|ANOVA=Analysis of variance||PCS-12: Employment Status||||=0.8241
73898999|NCT04876690|147329317|SUPERIORITY||||||=|0.3471|||||||ANOVA|||PCS-12: Smoking Status||||=0.3471
73899000|NCT04876690|147329317|SUPERIORITY||||||=|0.9951|||||||ANOVA|||PCS-12: Age at Onset||||=0.9951
73899001|NCT04876690|147329317|SUPERIORITY||||||=|0.0631|||||||ANOVA|||PCS-12: Disease Location||||=0.0631
73899002|NCT04876690|147329317|SUPERIORITY||||||=|0.7473|||||||ANOVA|||PCS-12: Disease Behavior||||=0.7473
73899003|NCT04876690|147329317|SUPERIORITY||||||=|0.4422|||||||t-test for Independent Samples|||PCS-12: Presence of any Extraintestinal Manifestation of CD||||=0.4422
73899004|NCT04876690|147329317|SUPERIORITY||||||=|0.1796|||||||t-test for Independent Samples|||PCS-12: Fistula With High Intersphincteric Type||||=0.1796
73899005|NCT04876690|147329317|SUPERIORITY||||||=|0.3535|||||||t-test for Independent Samples|||PCS-12: Fistula With High Transsphincteric Type||||=0.3535
73899006|NCT04876690|147329317|SUPERIORITY||||||=|0.1508|||||||t-test for Independent Samples|||PCS-12: Fistula With Suprasphincteric Type||||=0.1508
73899007|NCT04876690|147329317|SUPERIORITY||||||=|0.2671|||||||t-test for Independent Samples|||PCS-12: Fistula with Extrasphincteric Type||||=0.2671
73960010|NCT01713946|147455403|SUPERIORITY||Difference in least square means|0.4|||||TWO_SIDED|95.0|-7.8|8.6||||||||8.6|-7.8|
73960011|NCT01713946|147455404|SUPERIORITY||Difference in least square means|-2.8|||||TWO_SIDED|95.0|-17.9|12.3||||||||12.3|-17.9|
73960012|NCT01713946|147455404|SUPERIORITY||Difference in least square means|-7.7|||||TWO_SIDED|95.0|-22.0|6.6||||||||6.6|-22.0|
73960013|NCT04493242|147455436|OTHER|log-rank test||||||0.1343|||||||Chi-squared|||||||0.1343
73960014|NCT01942707|147455442|SUPERIORITY||Mean Difference (Final Values)|179.0|STANDARD_DEVIATION|222.0||0.003|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
73960015|NCT01942707|147455443|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.9||0.012|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.012
74084368|NCT02760433|147721936|SUPERIORITY||Risk Difference (RD)|0.19||||0.004|TWO_SIDED|97.5|0.03|0.337|||Chi-squared|2x2 chi-square test||The ACR20 response rate at Week 12 for the placebo group is estimated to be 20% in this study population. The OKZ ACR20 response rate for 64 mg q4w treatment group at Week 12 are expected to be at least 45%, resulting in an expected difference in ACR20 response rates of 25 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.337|0.030|0.004
73846290|NCT01819272|147238695|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-28.0|||<|0.0001|TWO_SIDED|95.0|-42.0|-17.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-17.0|-42.0|<0.0001
73846291|NCT01819272|147238696|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-106.0||||0.0226|TWO_SIDED|95.0|-208.0|-16.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-16.00|-208.0|0.0226
73846292|NCT01819272|147238696|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-106.0||||0.0068|TWO_SIDED|95.0|-180.0|-32.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-32.00|-180.0|0.0068
73846293|NCT01819272|147238696|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-152.0||||0.0071|TWO_SIDED|95.0|-252.0|-42.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-42.00|-252.0|0.0071
73846294|NCT01819272|147238696|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-101.0||||0.0405|TWO_SIDED|95.0|-208.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-4.00|-208.0|0.0405
73846295|NCT01819272|147238696|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-224.0|||<|0.0001|TWO_SIDED|95.0|-334.0|-118.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-118.0|-334.0|<.0001
73846296|NCT01819272|147238697|SUPERIORITY_OR_OTHER||LS Mean|-0.48||||0.01|TWO_SIDED|95.0|-0.85|-0.12|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.12|-0.85|0.0100
73846297|NCT01819272|147238697|SUPERIORITY_OR_OTHER||LS Mean|-0.45||||0.0153|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.09|-0.81|0.0153
73846298|NCT01819272|147238697|SUPERIORITY_OR_OTHER||LS Mean|-0.35||||0.0611|TWO_SIDED|95.0|-0.71|0.02|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||0.02|-0.71|0.0611
73960016|NCT01942707|147455444|SUPERIORITY||Mean Difference (Final Values)|4.8|STANDARD_DEVIATION|40.7||0.809|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.809
73846299|NCT01819272|147238697|SUPERIORITY_OR_OTHER||LS Mean|-0.45||||0.0188|TWO_SIDED|95.0|-0.83|-0.08|||ANCOVA|Factor for treatment and baseline HbA1c as acovariate||||-0.08|-0.83|0.0188
73846300|NCT01819272|147238697|SUPERIORITY_OR_OTHER||LS Mean|-0.67||||0.0006|TWO_SIDED|95.0|-1.04|-0.29|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.29|-1.04|0.0006
73846301|NCT01732536|147238698|SUPERIORITY|||||||0.1365|||||||ANCOVA|Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.1365
73960017|NCT04541303|147455454|SUPERIORITY|||||||0.028|||||||None specified|||||||.028
73960018|NCT03538041|147455470|SUPERIORITY|||||||0.2815|||||||ANOVA|||Week 2||||0.2815
73960019|NCT03538041|147455471|SUPERIORITY|||||||0.2921|||||||Kruskal-Wallis|||Week 2||||0.2921
73960020|NCT03538041|147455472|SUPERIORITY|||||||0.1267|||||||ANOVA|||Week 2||||0.1267
73960021|NCT03538041|147455473|SUPERIORITY|||||||0.2676|||||||ANOVA|||Week 2||||0.2676
73960022|NCT02477670|147455607|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.79||||0.073|TWO_SIDED|95.0|-3.75|0.17|||Mixed Models Analysis|||Sequential Parallel Comparison Design (SPCD) Weighted Ordinary Least Squares (OLS) z-statistic. Treatment differences in each stage were estimated by the Mixed Model Repeated Measures (MMRM).||0.17|-3.75|0.073
73960023|NCT02477670|147455608|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.25||||0.025|TWO_SIDED|95.0|-4.21|-0.29|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.29|-4.21|0.025
73960024|NCT02477670|147455609|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.2||||0.027|TWO_SIDED|95.0|-4.16|-0.24|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.24|-4.16|0.027
73960025|NCT02477670|147455610|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.26||||0.024|TWO_SIDED|95.0|-4.22|-0.3|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.3|-4.22|0.024
73960026|NCT02477670|147455611|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.6||||0.009|TWO_SIDED|95.0|-4.56|-0.64|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.64|-4.56|0.009
73960027|NCT02477670|147455612|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.39||||0.7|TWO_SIDED|95.0|-2.35|1.57|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.57|-2.35|0.700
73960028|NCT02477670|147455613|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.93||||0.054|TWO_SIDED|95.0|-3.89|0.03|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.03|-3.89|0.054
73960029|NCT02477670|147455614|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.35||||0.723|TWO_SIDED|95.0|-2.31|1.61|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.61|-2.31|0.723
73960030|NCT02477670|147455615|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.85||||0.064|TWO_SIDED|95.0|-3.81|0.11|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.11|-3.81|0.064
73960031|NCT02477670|147455616|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.64||||0.1|TWO_SIDED|95.0|-3.6|0.32|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.32|-3.6|0.100
73960032|NCT02477670|147455617|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.86||||0.388|TWO_SIDED|95.0|-2.82|1.1|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.1|-2.82|0.388
73960033|NCT02477670|147455618|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.9||||0.367|TWO_SIDED|95.0|-2.86|1.06|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.06|-2.86|0.367
73960034|NCT02477670|147455619|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.76||||0.447|TWO_SIDED|95.0|-2.72|1.2|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.2|-2.72|0.447
73960035|NCT02477670|147455620|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.23||||0.026|TWO_SIDED|95.0|-4.19|-0.27|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.27|-4.19|0.026
73960036|NCT02477670|147455621|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.62||||0.106|TWO_SIDED|95.0|-3.58|0.34|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.34|-3.58|0.106
73899008|NCT04876690|147329317|SUPERIORITY||||||=|0.0594|||||||t-test for Independent Samples|||PCS-12: Fistula With Low Intersphincteric Type||||=0.0594
74022521|NCT01587950|147597588|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.99||||0.8918|TWO_SIDED|95.0|-15.5|13.52|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||13.52|-15.50|0.8918
73846302|NCT01732536|147238698|SUPERIORITY|||||||0.0505||||||Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects|ANCOVA|||The change from baseline to Day 90 in Nasal Obstruction/Congestion score in the subset of participants with higher polyp burden at baseline (grade 2 or higher polyps on each side; N=67).||||0.0505
73846303|NCT01732536|147238699|SUPERIORITY|||||||0.0985|||||||ANCOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect||||||0.0985
73846304|NCT01732536|147238699|SUPERIORITY|||||||0.049|||||||ANOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect||Bilateral polyp grade change in a subset of 67 patients with higher polyp burden at baseline (grade 2 or higher on each side confirmed by the independent panel)||||0.0490
73846305|NCT01732536|147238700|SUPERIORITY|||||||0.0099|||||||ANCOVA|||||||0.0099
73846306|NCT01732536|147238701|SUPERIORITY|||||||0.0162||||||P-value for change from baseline to 90 days not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0162
73846307|NCT01732536|147238701|SUPERIORITY|||||||0.0175||||||P-value for change from baseline to 6 months not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0175
73846308|NCT01732536|147238702|SUPERIORITY|||||||0.0209||||||P-value not adjusted for multiplicity.|ANCOVA|Based on between arm comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0209
73846309|NCT03235050|147238731|SUPERIORITY||LS Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.06|-0.59|||ANCOVA|||||-0.59|-1.06|<0.001
73846310|NCT03235050|147238731|SUPERIORITY||LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.23|-0.85|||ANCOVA|||||-0.85|-1.23|<0.001
73846311|NCT03235050|147238731|SUPERIORITY||LS Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.11|-0.72|||ANCOVA|||||-0.72|-1.11|<0.001
73846312|NCT03235050|147238732|SUPERIORITY||LS Mean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-3.08|-0.91|||ANCOVA|||||-0.91|-3.08|<0.001
73846313|NCT03235050|147238732|SUPERIORITY||LS Mean Difference|-2.76|||<|0.001|TWO_SIDED|95.0|-3.65|-1.87|||ANCOVA|||||-1.87|-3.65|<0.001
73846314|NCT03235050|147238732|SUPERIORITY||LS Mean Difference|-3.62|||<|0.001|TWO_SIDED|95.0|-4.51|-2.73|||ANCOVA|||||-2.73|-4.51|<0.001
73846315|NCT03235050|147238733|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.92|-0.4|||ANCOVA|||Week 26||-0.40|-0.92|<0.001
73846316|NCT03235050|147238733|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.03|-0.6|||ANCOVA|||Week 26||-0.60|-1.03|<0.001
73846317|NCT03235050|147238733|SUPERIORITY||LS Mean Difference|-0.72|||<|0.001|TWO_SIDED|95.0|-0.94|-0.51|||ANCOVA|||Week 26||-0.51|-0.94|<0.001
73846318|NCT03235050|147238733|SUPERIORITY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.8|-0.24|||ANCOVA|||Week 54||-0.24|-0.80|<0.001
73846319|NCT03235050|147238733|SUPERIORITY||LS Mean Difference|-0.63|||<|0.001|TWO_SIDED|95.0|-0.86|-0.39|||ANCOVA|||Week 54||-0.39|-0.86|<0.001
73846320|NCT03235050|147238733|SUPERIORITY||LS Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.8|-0.34|||ANCOVA|||Week 54||-0.34|-0.80|<0.001
73846321|NCT03235050|147238734|SUPERIORITY||Odds Ratio, log|6.67|||<|0.001|TWO_SIDED|92.0|3.34|13.3|||Regression, Logistic|||Week 14||13.30|3.34|<0.001
73846322|NCT03235050|147238734|SUPERIORITY||Odds Ratio, log|9.95|||<|0.001|TWO_SIDED|95.0|5.39|18.36|||Regression, Logistic|||Week 14||18.36|5.39|<0.001
73846323|NCT03235050|147238734|SUPERIORITY||Odds Ratio, log|8.52|||<|0.001|TWO_SIDED|95.0|4.65|15.61|||Regression, Logistic|||Week 14||15.61|4.65|<0.001
73846324|NCT03235050|147238734|SUPERIORITY||Odds Ratio, log|3.74|||<|0.001|TWO_SIDED|95.0|1.98|7.03|||Regression, Logistic|||Week 26||7.03|1.98|<0.001
73846325|NCT03235050|147238734|SUPERIORITY||Odds Ratio, log|5.4|||<|0.001|TWO_SIDED|95.0|3.13|9.34|||Regression, Logistic|||Week 26||9.34|3.13|<0.001
73846326|NCT03235050|147238734|SUPERIORITY||Odds Ratio, log|5.2|||<|0.001|TWO_SIDED|95.0|3.02|8.97|||Regression, Logistic|||Week 26||8.97|3.02|<0.001
73846327|NCT03235050|147238734|SUPERIORITY||Odds Ratio, log|4.94|||<|0.001|TWO_SIDED|95.0|2.61|9.36|||Regression, Logistic|||Week 54||9.36|2.61|<0.001
73846328|NCT03235050|147238734|SUPERIORITY||Odds Ratio, log|4.55|||<|0.001|TWO_SIDED|95.0|2.62|7.89|||Regression, Logistic|||Week 54||7.89|2.62|<0.001
73846329|NCT03235050|147238734|SUPERIORITY||Odds Ratio, log|4.34|||<|0.001|TWO_SIDED|95.0|2.51|7.51|||Regression, Logistic|||Week 54||7.51|2.51|<0.001
73846330|NCT03235050|147238735|SUPERIORITY||LS Mean Difference|-2.09|||<|0.001|TWO_SIDED|95.0|-3.32|-0.85|||ANCOVA|||Week 26||-0.85|-3.32|<0.001
73846331|NCT03235050|147238735|SUPERIORITY||LS Mean Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-3.82|-1.79|||ANCOVA|||Week 26||-1.79|-3.82|<0.001
73846332|NCT03235050|147238735|SUPERIORITY||LS Mean Difference|-3.46|||<|0.001|TWO_SIDED|95.0|-4.48|-2.44|||ANCOVA|||Week 26||-2.44|-4.48|<0.001
73846333|NCT03235050|147238735|SUPERIORITY||LS Mean Difference|-2.43|||<|0.001|TWO_SIDED|95.0|-3.86|-1.0|||ANCOVA|||Week 54||-1.00|-3.86|<0.001
73846334|NCT03235050|147238735|SUPERIORITY||LS Mean Difference|-2.24|||<|0.001|TWO_SIDED|95.0|-3.41|-1.06|||ANCOVA|||Week 54||-1.06|-3.41|<0.001
73846335|NCT03235050|147238735|SUPERIORITY||LS Mean Difference|-3.32|||<|0.001|TWO_SIDED|95.0|-4.49|-2.14|||ANCOVA|||Week 54||-2.14|-4.49|<0.001
73899009|NCT04876690|147329317|SUPERIORITY||||||=|0.5484|||||||t-test for Independent Samples|||PCS-12: Fistula With Low Transsphincteric Type||||=0.5484
73846336|NCT03235050|147238736|SUPERIORITY||LS Mean Difference|-1.95|||<|0.001|TWO_SIDED|95.0|-3.03|-0.87|||ANCOVA|||Week 14||-0.87|-3.03|<0.001
73846337|NCT03235050|147238736|SUPERIORITY||LS Mean Difference|-2.75|||<|0.001|TWO_SIDED|95.0|-3.63|-1.86|||ANCOVA|||Week 14||-1.86|-3.63|<0.001
73846338|NCT03235050|147238736|SUPERIORITY||LS Mean Difference|-3.71|||<|0.001|TWO_SIDED|95.0|-4.6|-2.82|||ANCOVA|||Week 14||-2.82|-4.60|<0.001
73846339|NCT03235050|147238736|SUPERIORITY||LS Mean Difference|-2.01||||0.002|TWO_SIDED|95.0|-3.27|-0.74|||ANCOVA|||Week 26||-0.74|-3.27|0.002
73846340|NCT03235050|147238736|SUPERIORITY||LS Mean Difference|-2.74|||<|0.001|TWO_SIDED|95.0|-3.78|-1.71|||ANCOVA|||Week 26||-1.71|-3.78|<0.001
73846341|NCT03235050|147238736|SUPERIORITY||LS Mean Difference|-3.55|||<|0.001|TWO_SIDED|95.0|-4.59|-2.52|||ANCOVA|||Week 26||-2.52|-4.59|<0.001
73846342|NCT03235050|147238736|SUPERIORITY||LS Mean Difference|-2.27||||0.003|TWO_SIDED|95.0|-3.74|-0.79|||ANCOVA|||Week 54||-0.79|-3.74|0.003
73846343|NCT03235050|147238736|SUPERIORITY||LS Mean Difference|-2.16|||<|0.001|TWO_SIDED|95.0|-3.37|-0.95|||ANCOVA|||Week 54||-0.95|-3.37|<0.001
73846344|NCT03235050|147238736|SUPERIORITY||LS Mean Difference|-3.42|||<|0.001|TWO_SIDED|95.0|-4.63|-2.2|||ANCOVA|||Week 54||-2.20|-4.63|<0.001
73846345|NCT03235050|147238737|SUPERIORITY||LS Mean Difference|0.7||||0.211|TWO_SIDED|95.0|-0.39|1.79|||ANCOVA|||Percent change at Week 14||1.79|-0.39|0.211
73846346|NCT03235050|147238737|SUPERIORITY||LS Mean Difference|-0.07||||0.881|TWO_SIDED|95.0|-0.96|0.83|||ANCOVA|||Percent change at Week 14||0.83|-0.96|0.881
73846347|NCT03235050|147238737|SUPERIORITY||LS Mean Difference|-0.93||||0.042|TWO_SIDED|95.0|-1.82|-0.04|||ANCOVA|||Percent change at Week 14||-0.04|-1.82|0.042
73846348|NCT03235050|147238737|SUPERIORITY||LS Mean Difference|0.9||||0.158|TWO_SIDED|95.0|-0.35|2.14|||ANCOVA|||Percent change at Week 26||2.14|-0.35|0.158
73846349|NCT03235050|147238737|SUPERIORITY||LS Mean Difference|0.18||||0.734|TWO_SIDED|95.0|-0.85|1.2|||ANCOVA|||Percent change at Week 26||1.20|-0.85|0.734
73846350|NCT03235050|147238737|SUPERIORITY||LS Mean Difference|-0.48||||0.357|TWO_SIDED|95.0|-1.51|0.54|||ANCOVA|||Percent change at Week 26||0.54|-1.51|0.357
73846351|NCT03235050|147238737|SUPERIORITY||LS Mean Difference|-0.07||||0.921|TWO_SIDED|95.0|-1.51|1.37|||ANCOVA|||Percent change at Week 54||1.37|-1.51|0.921
73899010|NCT04876690|147329317|SUPERIORITY||||||=|0.5387|||||||t-test for Independent Samples|||PCS-12: Fistula With Midline Position||||=0.5387
73846352|NCT03235050|147238737|SUPERIORITY||LS Mean Difference|0.12||||0.847|TWO_SIDED|95.0|-1.07|1.3|||ANCOVA|||Percent change at Week 54||1.30|-1.07|0.847
73899011|NCT04876690|147329317|SUPERIORITY||||||=|0.527|||||||t-test for Independent Samples|||PCS-12: Fistula With Lateral Position||||=0.5270
73960037|NCT02477670|147455622|SUPERIORITY||SPCD Weighted OLS z-statistic|1.78||||0.074|TWO_SIDED|95.0|-0.18|3.74|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||3.74|-0.18|0.074
73846353|NCT03235050|147238737|SUPERIORITY||LS Mean Difference|-0.96||||0.112|TWO_SIDED|95.0|-2.15|0.22|||ANCOVA|||Percent change at Week 54||0.22|-2.15|0.112
73960038|NCT02477670|147455623|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.79||||0.427|TWO_SIDED|95.0|-2.75|1.17|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.17|-2.75|0.427
73846354|NCT03235050|147238738|SUPERIORITY||LS Mean Difference|0.59||||0.284|TWO_SIDED|95.0|-0.49|1.68|||ANCOVA|||Absolute change at Week 14||1.68|-0.49|0.284
73846355|NCT03235050|147238738|SUPERIORITY||LS Mean Difference|-0.2||||0.658|TWO_SIDED|95.0|-1.09|0.69|||ANCOVA|||Absolute change at Week 14||0.69|-1.09|0.658
73846356|NCT03235050|147238738|SUPERIORITY||LS Mean Difference|-1.17||||0.01|TWO_SIDED|95.0|-2.06|-0.27|||ANCOVA|||Absolute change at Week 14||-0.27|-2.06|0.010
73846357|NCT03235050|147238738|SUPERIORITY||LS Mean Difference|0.7||||0.279|TWO_SIDED|95.0|-0.57|1.97|||ANCOVA|||Absolute change at Week 26||1.97|-0.57|0.279
73846358|NCT03235050|147238738|SUPERIORITY||LS Mean Difference|-0.04||||0.94|TWO_SIDED|95.0|-1.08|1.0|||ANCOVA|||Absolute change at Week 26||1.00|-1.08|0.940
73846359|NCT03235050|147238738|SUPERIORITY||LS Mean Difference|-0.85||||0.11|TWO_SIDED|95.0|-1.89|0.19|||ANCOVA|||Absolute change at Week 26||0.19|-1.89|0.110
73846360|NCT03235050|147238738|SUPERIORITY||LS Mean Difference|-0.26||||0.73|TWO_SIDED|95.0|-1.74|1.22|||ANCOVA|||Absolute change at Week 54||1.22|-1.74|0.730
73846361|NCT03235050|147238738|SUPERIORITY||LS Mean Difference|-0.15||||0.804|TWO_SIDED|95.0|-1.38|1.07|||ANCOVA|||Absolute change at Week 54||1.07|-1.38|0.804
73846362|NCT03235050|147238738|SUPERIORITY||LS Mean Difference|-1.41||||0.023|TWO_SIDED|95.0|-2.63|-0.19|||ANCOVA|||Absolute change at Week 54||-0.19|-2.63|0.023
73846363|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|8.37|||<|0.001|TWO_SIDED|95.0|2.38|29.43|||Regression, Logistic|||weight loss \>=5% at Week 14||29.43|2.38|<0.001
73846364|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|12.46|||<|0.001|TWO_SIDED|95.0|3.82|40.64|||Regression, Logistic|||weight loss \>=5% at Week 14||40.64|3.82|<0.001
73846365|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|21.26|||<|0.001|TWO_SIDED|95.0|6.55|68.97|||Regression, Logistic|||weight loss \>=5% at Week 14||68.97|6.55|<0.001
73899012|NCT04876690|147329317|SUPERIORITY||||||=|0.3863|||||||t-test for Independent Samples|||PCS-12: Fistula With Seton||||=0.3863
73899013|NCT04876690|147329317|SUPERIORITY||||||=|0.4206|||||||ANOVA|||PCS-12: HBI Categories (Remission, Mild and Moderate Activity)||||=0.4206
73899014|NCT04876690|147329317|SUPERIORITY||||||=|0.0538|||||||t-test for Independent Samples|||PCS-12: Surgery-naïve||||=0.0538
73960039|NCT02477670|147455624|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.91||||0.0566|TWO_SIDED|95.0|-3.87|0.05|||McNemar|||Treatment differences in each stage were estimated by the MMRM.||0.05|-3.87|0.0566
73899015|NCT04876690|147329317|SUPERIORITY||||||=|0.9572|||||||t-test for Independent Samples|||PCS-12: Surgery - Fistulotomy||||=0.9572
73899016|NCT04876690|147329317|SUPERIORITY||||||=|0.4742|||||||t-test for Independent Samples|||PCS-12: Surgery - Loose Seton||||=0.4742
73899017|NCT04876690|147329317|SUPERIORITY||||||=|0.5735|||||||t-test for Independent Samples|||PCS-12: Surgery - Other||||=0.5735
73899018|NCT04876690|147329317|SUPERIORITY||||||=|0.376|||||||t-test for Independent Samples|||PCS-12: Presence of Perianal Abscess||||=0.3760
73899019|NCT04876690|147329318|SUPERIORITY||||||=|0.4814|||||||t-test for Independent Samples|||MCS-12: Sex||||=0.4814
73960040|NCT02477670|147455625|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.37||||0.17|TWO_SIDED|95.0|-3.33|0.59|||ANCOVA|||||0.59|-3.33|0.1700
73846366|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|3.68|||<|0.001|TWO_SIDED|95.0|1.72|7.89|||Regression, Logistic|||weight loss \>=5% at Week 26||7.89|1.72|<0.001
73846367|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|3.95|||<|0.001|TWO_SIDED|95.0|2.0|7.78|||Regression, Logistic|||weight loss \>=5% at Week 26||7.78|2.00|<0.001
73846368|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|7.28|||<|0.001|TWO_SIDED|95.0|3.72|14.24|||Regression, Logistic|||weight loss \>=5% at Week 26||14.24|3.72|<0.001
73846369|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|3.71|||<|0.001|TWO_SIDED|95.0|1.84|7.45|||Regression, Logistic|||weight loss \>=5% at Week 54||7.45|1.84|<0.001
73846370|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|2.73||||0.002|TWO_SIDED|95.0|1.46|5.09|||Regression, Logistic|||weight loss \>=5% at Week 54||5.09|1.46|0.002
73846371|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|4.48|||<|0.001|TWO_SIDED|95.0|2.42|8.3|||ANCOVA|||weight loss \>=5% at Week 54||8.30|2.42|<0.001
73846372|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|8.47||||0.048|TWO_SIDED|95.0|1.02|70.17|||Regression, Logistic|||weight loss \>=10% at Week 26||70.17|1.02|0.048
73846373|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|13.81||||0.01|TWO_SIDED|95.0|1.85|102.91|||Regression, Logistic|||weight loss \>=10% at Week 26||102.91|1.85|0.010
73846374|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|13.09||||0.012|TWO_SIDED|95.0|1.75|97.68|||Regression, Logistic|||weight loss \>=10% at Week 26||97.68|1.75|0.012
73846375|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|6.92||||0.013|TWO_SIDED|95.0|1.49|32.07|||Regression, Logistic|||weight loss \>=10% at Week 54||32.07|1.49|0.013
73846376|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|4.98||||0.032|TWO_SIDED|95.0|1.15|21.6|||Regression, Logistic|||weight loss \>=10% at Week 54||21.60|1.15|0.032
73846377|NCT03235050|147238739|SUPERIORITY||Odds Ratio, log|7.91||||0.005|TWO_SIDED|95.0|1.86|33.64|||Regression, Logistic|||weight loss \>=10% at Week 54||33.64|1.86|0.005
73846378|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.09||||0.024|TWO_SIDED|95.0|0.01|0.73|||Regression, Logistic|||received rescue medication at 14 wks||0.73|0.01|0.024
73846379|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.11|||<|0.001|TWO_SIDED|95.0|0.03|0.4|||Regression, Logistic|||received rescue medication at 14 wks||0.40|0.03|<0.001
73846380|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.07|||<|0.001|TWO_SIDED|95.0|0.02|0.33|||Regression, Logistic|||received rescue medication at 14 wks||0.33|0.02|<0.001
73846381|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.14||||0.002|TWO_SIDED|95.0|0.04|0.48|||Regression, Logistic|||received rescue medication at 26 wks||0.48|0.04|0.002
73846382|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.14|||<|0.001|TWO_SIDED|95.0|0.06|0.34|||Regression, Logistic|||received rescue medication at 26 wks||0.34|0.06|<0.001
73846383|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.11|||<|0.001|TWO_SIDED|95.0|0.04|0.28|||Regression, Logistic|||received rescue medication at 26 wks||0.28|0.04|<0.001
73846384|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.24|||<|0.001|TWO_SIDED|95.0|0.11|0.53|||Regression, Logistic|||received rescue medication at 54 wks||0.53|0.11|<0.001
73846385|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.24|||<|0.001|TWO_SIDED|95.0|0.13|0.44|||Regression, Logistic|||received rescue medication at 54 wks||0.44|0.13|<0.001
73846386|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.22|||<|0.001|TWO_SIDED|95.0|0.12|0.41|||Regression, Logistic|||received rescue medication at 54 wks||0.41|0.12|<0.001
73846387|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.22||||0.216|TWO_SIDED|95.0|0.02|2.43|||Regression, Logistic|||discontinued IP at 14 wks||2.43|0.02|0.216
73846388|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.28||||0.253|TWO_SIDED|95.0|0.03|2.52|||Regression, Logistic|||discontinued IP at 26 wks||2.52|0.03|0.253
73846389|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.21||||0.079|TWO_SIDED|95.0|0.04|1.19|||Regression, Logistic|||discontinued IP at 26 wks||1.19|0.04|0.079
73846390|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.27||||0.252|TWO_SIDED|95.0|0.03|2.5|||Regression, Logistic|||discontinued IP at 54 wks||2.50|0.03|0.252
73846391|NCT03235050|147238740|SUPERIORITY||Odds Ratio, log|0.32||||0.143|TWO_SIDED|95.0|0.07|1.47|||Regression, Logistic|||discontinued IP at 54 wks||1.47|0.07|0.143
73846392|NCT01622296|147238747|SUPERIORITY_OR_OTHER|||||||0.23||||||Significant at p\<0.05|t-test, 2 sided|||Inferior Alveolar nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)||||0.23
73846393|NCT01622296|147238747|SUPERIORITY_OR_OTHER|||||||0.57||||||Significant at p\<0.05|t-test, 2 sided|||Long buccal nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)||||0.57
73846394|NCT02415556|147238748|OTHER|"A spatial power variance-covariance structure was used to model within-subject correlated measurements where the number of days from the baseline visit was used as the power of the autoregressive correlation coefficient. Each efficacy and safety outcome variable was modeled separately.~The independent variables included: 4 treatment groups, TIMEG (baseline, on-treatment and post-treatment period), TIMEG \* treatment group.; an average number of treatment days; subjects as random effects."|Mean Difference (Final Values)|6.52||||0.025|TWO_SIDED|95.0|0.81|12.23||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||12.23|0.81|0.025
73899020|NCT04876690|147329318|SUPERIORITY||||||=|0.3136|||||||Kruskal-Wallis|||MCS-12: Employment Status||||=0.3136
73899021|NCT04876690|147329318|SUPERIORITY||||||=|0.5808|||||||ANOVA|||MCS-12: Smoking Status||||=0.5808
73899022|NCT04876690|147329318|SUPERIORITY||||||=|0.2965|||||||ANOVA|||MCS-12: Age at Onset||||=0.2965
73899023|NCT04876690|147329318|SUPERIORITY||||||=|0.2874|||||||ANOVA|||MCS-12: Disease Location||||=0.2874
73846395|NCT02415556|147238748|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|5.28||||0.051|TWO_SIDED|95.0|-0.03|10.6||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||10.60|-0.03|0.051
73899024|NCT04876690|147329318|SUPERIORITY||||||=|0.4269|||||||ANOVA|||MCS-12: Disease Behavior||||=0.4269
73899025|NCT04876690|147329318|SUPERIORITY||||||=|0.8931|||||||t-test for Independent Samples|||MCS-12: Presence of any Extraintestinal Manifestation of CD||||=0.8931
73899026|NCT04876690|147329318|SUPERIORITY||||||=|0.9384|||||||t-test for Independent Samples|||MCS-12: Fistula With High Intersphincteric Type||||=0.9384
73899027|NCT04876690|147329318|SUPERIORITY||||||=|0.8286|||||||Mann-Whitney|||MCS-12: Fistula With High Transsphincteric Type||||=0.8286
73899028|NCT04876690|147329318|SUPERIORITY||||||=|0.1919|||||||t-test for Independent Samples|||MCS-12: Fistula With Suprasphincteric Type||||=0.1919
73899029|NCT04876690|147329318|SUPERIORITY||||||=|0.6452|||||||t-test for Independent Samples|||MCS-12: Fistula with Extrasphincteric Type||||=0.6452
73899030|NCT04876690|147329318|SUPERIORITY||||||=|0.7218|||||||t-test for Independent Samples|||MCS-12: Fistula With Low Intersphincteric Type||||=0.7218
73846396|NCT02415556|147238749|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|8.31||||0.007|TWO_SIDED|95.0|2.33|14.29||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||14.29|2.33|0.007
73846397|NCT02415556|147238749|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|2.71||||0.342|TWO_SIDED|95.0|-2.9|8.32||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||8.32|-2.90|0.342
73899031|NCT04876690|147329318|SUPERIORITY||||||=|0.9738|||||||t-test for Independent Samples|||MCS-12: Fistula With Low Transsphincteric Type||||=0.9738
73899032|NCT04876690|147329318|SUPERIORITY||||||=|0.2419|||||||t-test for Independent Samples|||MCS-12: Fistula With Midline Position||||=0.2419
73899033|NCT04876690|147329318|SUPERIORITY||||||=|0.5524|||||||t-test for Independent Samples|||MCS-12: Fistula With Lateral Position||||=0.5524
73899034|NCT04876690|147329318|SUPERIORITY||||||=|0.4443|||||||t-test for Independent Samples|||MCS-12: Fistula With Seton||||=0.4443
73899035|NCT04876690|147329318|SUPERIORITY||||||=|0.4106|||||||ANOVA|||MCS-12: HBI Categories (Remission, Mild and Moderate Activity)||||=0.4106
73899036|NCT04876690|147329318|SUPERIORITY||||||=|0.7795|||||||t-test for Independent Samples|||MCS-12: Surgery-naïve||||=0.7795
73899037|NCT04876690|147329318|SUPERIORITY||||||=|0.2964|||||||t-test for Independent Samples|||MCS-12: Surgery - Fistulotomy||||=0.2964
73899038|NCT04876690|147329318|SUPERIORITY||||||=|0.3287|||||||t-test for Independent Samples|||MCS-12: Surgery - Loose Seton||||=0.3287
73899039|NCT04876690|147329318|SUPERIORITY||||||=|0.0091|||||||t-test for Independent Samples|||MCS-12: Surgery - Other||||=0.0091
73899040|NCT04876690|147329318|SUPERIORITY||||||=|0.3889|||||||t-test for Independent Samples|||MCS-12: Presence of Perianal Abscess||||=0.3889
73899041|NCT04876690|147329319|SUPERIORITY||||||=|0.8001|||||||Pearson Correlation Coefficient|||PCS- 12: Age||||=0.8001
73899042|NCT04876690|147329319|SUPERIORITY||||||=|0.4532|||||||Pearson Correlation Coefficient|||PCS- 12: BMI||||=0.4532
73899043|NCT04876690|147329319|SUPERIORITY||||||=|0.9597|||||||Spearman Correlation Coefficient|||PCS- 12: Time Between CD Diagnosis Date and Date of Study Visit||||=0.9597
73899044|NCT04876690|147329319|SUPERIORITY||||||=|0.3304|||||||Spearman Correlation Coefficient|||PCS- 12: Total Number of CPFs per Participant||||=0.3304
73899045|NCT04876690|147329319|SUPERIORITY||||||=|0.6333|||||||Pearson Correlation Coefficient|||PCS- 12: Time Since Seton Replacement||||=0.6333
73899046|NCT04876690|147329319|SUPERIORITY||||||=|0.8003|||||||Spearman Correlation Coefficient|||PCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit||||=0.8003
73899047|NCT04876690|147329319|SUPERIORITY||||||=|0.0032|||||||Pearson Correlation Coefficient|||PCS- 12: PDAI Score||||=0.0032
73899048|NCT04876690|147329319|SUPERIORITY||||||=|0.0923|||||||Spearman Correlation Coefficient|||PCS- 12: Number of Internal Fistula Openings per Participant||||=0.0923
73899049|NCT04876690|147329319|SUPERIORITY||||||=|0.0994|||||||Spearman Correlation Coefficient|||PCS- 12: Number of External Fistula Openings per Participant||||=0.0994
73899050|NCT04876690|147329319|SUPERIORITY||||||=|0.0444|||||||Pearson Correlation Coefficient|||PCS- 12: SIBDQ Score||||=0.0444
73899051|NCT04876690|147329319|SUPERIORITY||||||=|0.086|||||||Pearson Correlation Coefficient|||PCS- 12: SQoL-M Score||||=0.0860
73899052|NCT04876690|147329319|SUPERIORITY||||||=|0.9415|||||||Pearson Correlation Coefficient|||PCS- 12: SQoL-F Score||||=0.9415
73846398|NCT02415556|147238750|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|-0.37||||0.144|TWO_SIDED|95.0|-0.87|0.13||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.13|-0.87|0.144
73846399|NCT02415556|147238750|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|-0.64||||0.008|TWO_SIDED|95.0|-1.11|-0.16||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||-0.16|-1.11|0.008
73846400|NCT02415556|147238751|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|0.35||||0.149|TWO_SIDED|95.0|-0.13|0.83||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.83|-0.13|0.149
73846401|NCT02415556|147238751|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|0.35||||0.134|TWO_SIDED|95.0|-0.11|0.8||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.80|-0.11|0.134
73846402|NCT02415556|147238752|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|10.29||||0.03|TWO_SIDED|95.0|1.0|19.58|||Mixed Models Analysis|||||19.58|1.00|0.030
73846403|NCT02415556|147238752|OTHER|See primary aims.|Mean Difference (Final Values)|2.21||||0.607|TWO_SIDED|95.0|-6.22|10.63||See primary aims.|Mixed Models Analysis|||See primary aims.||10.63|-6.22|0.607
73846404|NCT02415556|147238753|OTHER|See primary aims.|Mean Difference (Final Values)|-2.1||||0.576|TWO_SIDED|95.0|-9.5|5.29||See primary aims.|Mixed Models Analysis|||See primary aims.||5.29|-9.50|0.576
73846405|NCT02415556|147238753|OTHER|See primary aims.|Mean Difference (Final Values)|-0.86||||0.802|TWO_SIDED|95.0|-7.58|5.87||See primary aims.|Mixed Models Analysis|||See primary aims.||5.87|-7.58|0.802
73846406|NCT02415556|147238754|EQUIVALENCE|CBF and vasoreactivity maps were analyzed on a voxel-by-voxel basis using Statistical non-Parametric Mapping (SnPM, http://www.sph.umich.edu/ni-stat/SnPM/), voxel-level threshold p \< 0.005.||||||0.03|||||||Voxel-Based Morphometry|||||||0.03
73846407|NCT01621178|147238757|NON_INFERIORITY|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.26|0.15|||Mixed Models Analysis|||Week 26||0.15|-0.26|<0.001
73846408|NCT01621178|147238757|NON_INFERIORITY|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|0.02|||<|0.001|TWO_SIDED|95.0|-0.18|0.22|||Mixed Models Analysis|||Week 26||0.22|-0.18|<0.001
73846409|NCT02896257|147238786|SUPERIORITY||Odds Ratio (OR)|3.66|||<|0.001|TWO_SIDED|95.0|2.5|5.38|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||5.38|2.50|<0.001
73846410|NCT02896257|147238787|SUPERIORITY||Odds Ratio (OR)|0.8||||0.47|TWO_SIDED|95.0|0.44|1.47|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||1.47|0.44|0.47
73846411|NCT02896257|147238788|SUPERIORITY||Odds Ratio (OR)|0.63||||0.42|TWO_SIDED|95.0|0.2|1.96|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||1.96|0.20|0.42
73899053|NCT04876690|147329319|SUPERIORITY||||||=|0.3709|||||||Pearson Correlation Coefficient|||PCS- 12: Wexner Score||||=0.3709
73899054|NCT04876690|147329320|SUPERIORITY||||||=|0.0674|||||||Pearson Correlation Coefficient|||MCS- 12: Age||||=0.0674
73899055|NCT04876690|147329320|SUPERIORITY||||||=|0.9392|||||||Pearson Correlation Coefficient|||MCS- 12: BMI||||=0.9392
73899056|NCT04876690|147329320|SUPERIORITY||||||=|0.6387|||||||Spearman Correlation Coefficient|||MCS- 12: Time Between CD Diagnosis Date and Date of Study Visit||||=0.6387
73899057|NCT04876690|147329320|SUPERIORITY||||||=|0.7846|||||||Spearman Correlation Coefficient|||MCS- 12: Total Number of CPFs per Participant||||=0.7846
73899058|NCT04876690|147329320|SUPERIORITY||||||=|0.3972|||||||Pearson Correlation Coefficient|||MCS- 12: Time Since Seton Placement||||=0.3972
74022522|NCT01587950|147597588|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.89||||0.5183|TWO_SIDED|95.0|-19.91|10.14|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.14|-19.91|0.5183
74022523|NCT01587950|147597588|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.89||||0.5718|TWO_SIDED|95.0|-17.59|9.8|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||9.80|-17.59|0.5718
74022524|NCT01587950|147597588|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.37||||0.6591|TWO_SIDED|95.0|-11.82|18.56|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||18.56|-11.82|0.6591
74022525|NCT01587950|147597588|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.02||||0.6921|TWO_SIDED|95.0|-18.17|12.13|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||12.13|-18.17|0.6921
73846412|NCT00372957|147238805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-2.28|-1.93|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||-1.93|-2.28|
73846413|NCT00372957|147238805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|||||TWO_SIDED|95.0|-2.33|-1.98|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||-1.98|-2.33|
73899059|NCT04876690|147329320|SUPERIORITY||||||=|0.9496|||||||Spearman Correlation Coefficient|||MCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit||||=0.9496
73899060|NCT04876690|147329320|SUPERIORITY||||||=|0.813|||||||Pearson Correlation Coefficient|||MCS- 12: PDAI Score||||=0.8130
73899061|NCT04876690|147329320|SUPERIORITY||||||=|0.4588|||||||Spearman Correlation Coefficient|||MCS- 12: Number of Internal Fistula Openings per Participant||||=0.4588
73899062|NCT04876690|147329320|SUPERIORITY||||||=|0.8663|||||||Spearman Correlation Coefficient|||MCS- 12: Number of External Fistula Openings per Participant||||=0.8663
73846414|NCT00372957|147238805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|||||TWO_SIDED|95.0|-2.15|-1.82|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||-1.82|-2.15|
73846415|NCT00372957|147238805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12|||||TWO_SIDED|95.0|-2.28|-1.95|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||-1.95|-2.28|
73899063|NCT04876690|147329320|SUPERIORITY||||||=|0.1349|||||||Pearson Correlation Coefficient|||MCS- 12: SIBDQ Score||||=0.1349
73899064|NCT04876690|147329320|SUPERIORITY||||||=|0.5647|||||||Pearson Correlation Coefficient|||MCS- 12: SQoL-M Score||||=0.5647
73899065|NCT04876690|147329320|SUPERIORITY||||||=|0.9509|||||||Pearson Correlation Coefficient|||MCS- 12: SQoL-F Score||||=0.9509
73846416|NCT00372957|147238806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.87|||||TWO_SIDED|95.0|2.33|5.41|||Double-delta analysis||he point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||5.41|2.33|
73899066|NCT04876690|147329320|SUPERIORITY||||||=|0.5328|||||||Pearson Correlation Coefficient|||MCS- 12: Wexner Score||||=0.5328
73899067|NCT00308581|147329325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.696||95.0|0.7|1.7||Logistic regression model including terms for treatment arm and geographical region (North America versus Europe).|Regression, Logistic||Direction of comparison is Q4W regimen (active 1) versus Q2W regimen (active 2).|With a sample size of 165 patients per treatment arm, assuming a percentage of responders of 45% with the Q4W regimen, the study had 80% power to show a statistically significant difference in percentage of responders at Week 26 between the two treatment groups, when there is a true difference of 16% in percentage of responders in favor of the Q2W regimen, and using a 2-sided chi-square at the 5% significance level.||1.7|0.7|0.696
73899068|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|2.7||0.78|TWO_SIDED|95.0|-5.0|11.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||11.2|-5.0|0.78
73899069|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.5||0.75|TWO_SIDED|95.0|-4.6|10.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||10.7|-4.6|0.75
73846417|NCT00372957|147238806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||||TWO_SIDED|95.0|3.7|6.73|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||6.73|3.70|
73846418|NCT00372957|147238806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|||||TWO_SIDED|95.0|1.9|4.54|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||4.54|1.90|
73846419|NCT00372957|147238806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.39|||||TWO_SIDED|95.0|3.1|5.68|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||5.68|3.10|
73846420|NCT00372957|147238807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56|||||TWO_SIDED|95.0|-6.0|2.89|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||2.89|-6.00|
74022526|NCT01587950|147597588|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.39||||0.3513|TWO_SIDED|95.0|-19.98|7.2|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||7.20|-19.98|0.3513
73846421|NCT00372957|147238807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||||TWO_SIDED|95.0|-3.3|5.72|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||5.72|-3.30|
73846422|NCT00372957|147238807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||||TWO_SIDED|95.0|-5.2|2.5|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||2.50|-5.20|
73846423|NCT00372957|147238807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|-2.47|5.43|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||5.43|-2.47|
73846424|NCT00372957|147238808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-20.4|4.2|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||4.2|-20.4|
73846425|NCT00372957|147238808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|||||TWO_SIDED|95.0|-28.4|-3.9|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||-3.9|-28.4|
73960041|NCT02477670|147455626|SUPERIORITY||SPCD Weighted OLS z-statistic|0.53||||0.595|TWO_SIDED|95.0|-1.43|2.49|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||2.49|-1.43|0.595
73846426|NCT00372957|147238808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9|||||TWO_SIDED|95.0|-23.1|1.4|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.4|-23.1|
73846427|NCT00372957|147238808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-27.9|-3.3|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||-3.3|-27.9|
73846428|NCT00372957|147238809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.64|1.16|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||1.16|-0.64|
73846429|NCT00372957|147238809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-0.47|1.32|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||1.32|-0.47|
73846430|NCT00372957|147238809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||||TWO_SIDED|95.0|-0.37|1.07|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.07|-0.37|
73846431|NCT00372957|147238809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|||||TWO_SIDED|95.0|-0.24|1.21|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||1.21|-0.24|
73846432|NCT00372957|147238810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|||||TWO_SIDED|95.0|-40.7|0.9|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||0.9|-40.7|
73846433|NCT00372957|147238810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||||TWO_SIDED|95.0|-29.8|11.7|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||11.7|-29.8|
73846434|NCT00372957|147238810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|||||TWO_SIDED|95.0|-33.2|1.4|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.4|-33.2|
73846435|NCT00372957|147238810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2|||||TWO_SIDED|95.0|-23.4|11.1|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||11.1|-23.4|
73846436|NCT04778592|147238812|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.291||0.4549|TWO_SIDED|95.0|-0.36|0.79|||Mixed Models Analysis|||||0.79|-0.36|0.4549
73846437|NCT02441218|147238878|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||<|0.0001|TWO_SIDED|95.0|0.75|0.9|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.90|0.75|<0.0001
73846438|NCT02441218|147238879|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.128|TWO_SIDED|95.0|0.8|1.03|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||1.03|0.80|0.128
73846439|NCT02441218|147238880|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.66|0.83|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.83|0.66|< 0.0001
74022527|NCT01587950|147597588|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.96||||0.2346|TWO_SIDED|95.0|-5.96|23.88|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||23.88|-5.96|0.2346
74022528|NCT01587950|147597588|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.24||||0.4138|TWO_SIDED|95.0|-8.92|21.39|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.39|-8.92|0.4138
74022529|NCT01587950|147597588|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.72||||0.6931|TWO_SIDED|95.0|-16.44|10.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.99|-16.44|0.6931
74022530|NCT01587950|147597589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.39||||0.3867|TWO_SIDED|95.0|-21.04|8.26|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.26|-21.04|0.3867
74022531|NCT01587950|147597589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.22||||0.1448|TWO_SIDED|95.0|-26.41|3.96|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||3.96|-26.41|0.1448
73846440|NCT02441218|147238881|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.092|TWO_SIDED|95.0|0.8|1.02|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||1.02|0.80|0.092
73846441|NCT02441218|147238882|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.014|TWO_SIDED|95.0|0.58|0.94|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.94|0.58|0.0140
73846442|NCT02441218|147238883|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.0027|TWO_SIDED|95.0|0.82|0.96|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.96|0.82|0.0027
73846443|NCT02441218|147238884|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.0002|TWO_SIDED|95.0|0.78|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.92|0.78|0.0002
73846444|NCT02441218|147238885|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.0013|TWO_SIDED|95.0|0.81|0.95|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.95|0.81|0.0013
73846445|NCT02441218|147238886|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.0002|TWO_SIDED|95.0|0.77|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.92|0.77|0.0002
73846446|NCT02441218|147238887|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||<|0.0001|TWO_SIDED|95.0|0.74|0.89|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate. P-value: Wald test|||0.89|0.74|< 0.0001
73846447|NCT02431325|147238917|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
73846448|NCT02431325|147238918|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
73846449|NCT02431325|147238919|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
73846450|NCT02431325|147238920|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
73846451|NCT02431325|147238921|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73846452|NCT02431325|147238922|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
73846453|NCT02431325|147238923|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
73846454|NCT02431325|147238924|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
73846455|NCT02431325|147238925|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
73846456|NCT02431325|147238926|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
73846457|NCT02431325|147238927|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
73846458|NCT02431325|147238928|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
73846459|NCT02431325|147238929|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
73846460|NCT02431325|147238930|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
73846461|NCT02431325|147238931|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
73846462|NCT02431325|147238932|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
73846463|NCT02431325|147238933|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
73846464|NCT02431325|147238934|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Change from baseline at week 24||||0.09
74022532|NCT01587950|147597589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.83||||0.4874|TWO_SIDED|95.0|-18.66|8.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.99|-18.66|0.4874
74022533|NCT01587950|147597589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.87||||0.2038|TWO_SIDED|95.0|-25.23|5.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||5.49|-25.23|0.2038
74022534|NCT01587950|147597589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.12||||0.1518|TWO_SIDED|95.0|-26.43|4.19|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||4.19|-26.43|0.1518
74022535|NCT01587950|147597589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.25||||0.8567|TWO_SIDED|95.0|-14.98|12.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||12.49|-14.98|0.8567
74022536|NCT01587950|147597589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.01||||0.1493|TWO_SIDED|95.0|-4.06|26.08|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, at 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||26.08|-4.06|0.1493
74022537|NCT01587950|147597589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.45||||0.4798|TWO_SIDED|95.0|-9.86|20.76|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||20.76|-9.86|0.4798
74022538|NCT01587950|147597589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.56||||0.4255|TWO_SIDED|95.0|-19.42|8.29|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.29|-19.42|0.4255
74022539|NCT01587950|147597590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.96||||0.7769||95.0|-15.71|11.8||ANCOVA with factors for treatment group, application site, period and random effect for subject.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||11.80|-15.71|0.7769
74022540|NCT01587950|147597590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.32||||0.3811|TWO_SIDED|95.0|-20.64|8.0|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.00|-20.64|0.3811
73846465|NCT02431325|147238934|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Change from baseline at week 12||||0.25
73846466|NCT02431325|147238935|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
73899070|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.3||0.08|TWO_SIDED|95.0|-0.6|13.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||13.7|-0.6|0.08
73846467|NCT02431325|147238936|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
73846468|NCT00744861|147238937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905|||||||Cochran-Mantel-Haenszel|site stratified||||||0.9905
73846469|NCT01918189|147238987|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain interference (i.e., WHYMPI-Interference Scale) at 10 weeks post-baseline.||||||0.008||||||a priori threshold for statistical significance is p \<0.05|Regression, Logistic|||||||0.008
73960042|NCT02477670|147455627|SUPERIORITY||SPCD Weighted OLS z-statistic|2.284||||0.022|TWO_SIDED|95.0|0.324|4.244|||ANCOVA|||||4.244|0.324|0.022
73960043|NCT02477670|147455628|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.17||||0.862|TWO_SIDED|95.0|-2.13|1.79|||ANCOVA|||||1.79|-2.13|0.862
73846470|NCT01918189|147238988|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain intensity at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.27|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.27
73846471|NCT01918189|147238989|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.02|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.02
73899071|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|2.4||0.17|TWO_SIDED|95.0|-1.6|13.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||13.2|-1.6|0.17
73846472|NCT01918189|147238990|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.48|TWO_SIDED|||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.48
73846473|NCT01918189|147238991|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of sleep at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.18|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.18
73846474|NCT01918189|147238992|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of depression symptoms at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.03|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.03
73846475|NCT03060902|147239012|SUPERIORITY||F|10.16||||0.002|TWO_SIDED||||||ANOVA|||||||.002
73846476|NCT01240863|147239060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.134|TWO_SIDED|95.0|-0.11|0.82||statistical significance level of 0.05.|ANCOVA|Treatment and stratification (opioid naïve/opioid experienced) factors as the fixed effects; screening and baseline APIs as covariates.|placebo - hydrocodone|||0.82|-0.11|0.134
73846477|NCT00271544|147239131|SUPERIORITY_OR_OTHER||One sample proportion|0.955||||||95.0|0.92|0.955|||||1-side 95% confidence limit lower bound|||0.955|0.92|
73846478|NCT00271544|147239132|SUPERIORITY_OR_OTHER||One sample proportion|0.96||||||95.0|0.932|0.989||||||||0.989|0.932|
73846479|NCT00271544|147239133|SUPERIORITY_OR_OTHER||One sample mean|1.1|STANDARD_DEVIATION|0.9||||95.0|1.1|1.2|||||1-side 95% confidence limit upper bound|||1.2|1.1|
73846480|NCT00271544|147239134|SUPERIORITY_OR_OTHER||One sample mean|1.9|STANDARD_DEVIATION|2.0||||97.5|1.9|2.2|||||1-sided 97.5% confidence limit upper bound|||2.2|1.9|
73846481|NCT00271544|147239135|SUPERIORITY_OR_OTHER||One sample proportion|0.989||||||95.0|0.974|1.0||||||||1|0.974|
73846482|NCT00271544|147239136|SUPERIORITY_OR_OTHER||One sample proportion|0.973||||||95.0|0.95|0.996||||||||0.996|0.950|
73846483|NCT00271544|147239137|SUPERIORITY_OR_OTHER||One sample proportion|0.973||||||95.0|0.95|0.996||||||||0.996|0.950|
73846484|NCT03358030|147239151|OTHER||||||<|0.05|||||||ANOVA|||Day 12 through Day 260||||<0.05
73846485|NCT03358030|147239151|OTHER||||||<|0.05|||||||ANOVA|||Day 15 through Day 232||||<0.05
73846486|NCT03358030|147239152|OTHER||||||<|0.05|||||||Wilcoxon Rank Sum Test|Wilcoxon Rank Sum Test based on t approximation||Day 15 through Day 176||||< 0.05
73846487|NCT03358030|147239152|OTHER||||||<|0.05|||||||Wilcoxon Rank Sum Test|Wilcoxon Rank Sum Test based on t approximation||Day 12 through Day 176||||< 0.05
73846488|NCT04704193|147239207|OTHER|This arm includes descriptive statistics only.|count with proportion|0.955|||||TWO_SIDED|95.0|0.888|0.987||||||"Descriptive statistics only/proportion reported good or excellent~Q1a. Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk"||.987|.888|
73846489|NCT04704193|147239207|OTHER|This arm includes descriptive statistics only.|count with proportion|0.931|||||TWO_SIDED|95.0|0.856|0.974||||||"Descriptive statistics only/proportion reported good or excellent~Q1b. Genetic test results may help guide my treatment options"||.974|.856|
73846490|NCT04704193|147239207|OTHER|This arm includes descriptive statistics only.|count with proportion|0.943|||||TWO_SIDED|95.0|0.872|0.981||||||"Descriptive statistics only/proportion reported good or excellent~Q1c. Genetic test results may help me understand the future risks of other cancers"||.981|.872|
73846491|NCT04704193|147239207|OTHER|This arm includes descriptive statistics only.|count with proportion|0.851|||||TWO_SIDED|95.0|0.758|0.918||||||"Descriptive statistics only/proportion reported good or excellent~Q1d. Genetic test results may increase stress to me and my family members"||.918|.758|
73846492|NCT04704193|147239207|OTHER|This arm includes descriptive statistics only.|count with proportion|0.931|||||TWO_SIDED|95.0|0.856|0.974||||||"Descriptive statistics only/proportion reported good or excellent~Q1e. There are 3 gene panel options that include either a small, medium, or large number of genes"||.974|.856|
73846493|NCT04704193|147239207|OTHER|This arm includes descriptive statistics only.|count with proportion|0.919|||||TWO_SIDED|95.0|0.839|0.967||||||"Descriptive statistics only/proportion reported good or excellent~Q1f. Gene test results may come back as positive, negative or uncertain"||.967|.839|
73846494|NCT04704193|147239208|OTHER|Summary statistics only|Mean|13.7|STANDARD_DEVIATION|5.6|||TWO_SIDED|||||||||||||
73960044|NCT02477670|147455629|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.149||||0.251|TWO_SIDED|95.0|-3.109|0.811|||ANCOVA|||||0.811|-3.109|0.251
73899072|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|3.7||0.61|TWO_SIDED|95.0|-6.5|17.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||17.2|-6.5|0.61
73899073|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|3.1||0.32|TWO_SIDED|95.0|-4.1|16.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||16.8|-4.1|0.32
73899074|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|2.8||0.03|TWO_SIDED|95.0|1.6|22.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||22.3|1.6|0.03
73899075|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|3.1||0.04|TWO_SIDED|95.0|0.5|21.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||21.8|0.5|0.04
73899076|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||1|TWO_SIDED|95.0|-1.5|1.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||1.2|-1.5|1.00
73899077|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.88|TWO_SIDED|95.0|-3.5|2.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||2.3|-3.5|0.88
73899078|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.98|TWO_SIDED|95.0|-0.8|1.0|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||1.0|-0.8|0.98
73960045|NCT02477670|147455630|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.159||||0.246|TWO_SIDED|95.0|-3.119|0.801|||ANCOVA|||||0.801|-3.119|0.246
74022541|NCT01587950|147597590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.36||||0.5044||95.0|-17.35|8.63|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.63|-17.35|0.5044
74022542|NCT01587950|147597590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.68||||0.4374|TWO_SIDED|95.0|-20.2|8.84|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.84|-20.20|0.4374
74022543|NCT01587950|147597590|SUPERIORITY_OR_OTHER||Slope|-4.02||||0.5796|TWO_SIDED|95.0|-18.46|10.41|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.41|-18.46|0.5796
74022544|NCT01587950|147597590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66||||0.7994|TWO_SIDED|95.0|-11.32|14.64|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05||14.64|-11.32|0.7994
73846495|NCT01492426|147239209|NON_INFERIORITY_OR_EQUIVALENCE|Test of noninferiority was based on noninferiority margin of -12% and 2-sided alpha level of 5%. That is, if the lower bound of the 95% CI \> -12%, the Daclatasvir arm would be considered nonnferior to the telaprevir arm.|Percentage difference|4.3|STANDARD_DEVIATION|3.885|||TWO_SIDED|95.0|-3.3|11.9||Test of noninferiority carried out by taking a confidence interval (CI) for the difference in rates (daclatasvir arm minus telapravir arm). If lower bound of 95% CI difference exceeded -12%, noninferiority was demonstrated. No p-value was computed.|Stratum-adjusted Mantel-Haenszel|||Percentage difference between SVR12 rate in the experimental and control arms was computed using a stratum-adjusted Mantel-Haenszel confidence interval (95% level) for the difference in rates. The stratification factors were IL28B rs1297860 single nucleotide polymorphism (CC or non-CC) and baseline cirrhosis status (absent or present), unless otherwise indicated.||11.9|-3.3|
73846496|NCT01978145|147239215|NON_INFERIORITY_OR_EQUIVALENCE|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by CB DPI versus FSC administered BID by MD DPI is greater than -45 milliliter (mL).|Mean Difference (Net)|0.025|||||TWO_SIDED|95.0|0.002|0.047|||Repeated Measures Mixed Models|||||0.047|0.002|
73899079|NCT00899353|147329390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.2||0.98|TWO_SIDED|95.0|-6.6|5.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||5.3|-6.6|0.98
74088241|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.91|-0.27|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.91|0.0003
73846497|NCT01978145|147239216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|||||TWO_SIDED|95.0|-0.019|0.027|||||The estimated value and 95% CI values are provided for Day 28|||0.027|-0.019|
73846498|NCT01978145|147239216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|||||TWO_SIDED|95.0|-0.005|0.044|||||The estimated value and 95% CI values are provided for Day 56|||0.044|-0.005|
73846499|NCT01978145|147239217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166||||||95.0|-0.06|0.393||||||||0.393|-0.060|
73846500|NCT01978145|147239218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|||||TWO_SIDED|95.0|-0.278|0.272|||||The estimated and 95% CI values are presented for Day 28.|||0.272|-0.278|
73846501|NCT01978145|147239218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.069||||||95.0|-0.349|0.212|||||The estimated and 95% CI values are presented for Day 56.|||0.212|-0.349|
73846502|NCT01978145|147239218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.133|||||TWO_SIDED|95.0|-0.413|0.148|||||The estimated and 95% CI values are presented for Day 85.|||0.148|-0.413|
73846503|NCT01978145|147239219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.7|1.19||||||||1.19|-0.70|
73846504|NCT01978145|147239220|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.1|-0.02||||||||-0.02|-1.10|
73846505|NCT02777086|147239239|SUPERIORITY||||||<|0.001|||||||ANCOVA|||3-month outcome measures were compared between the StaySafe and Comparison groups controlling for the baseline measure using generalized linear models.||||<.001
73846506|NCT02122380|147239283|SUPERIORITY|||||||0.918|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of mean growth hormone (GH) levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided). A sample size of 16 participants was needed to provide 93% power to detect a difference in GH means of 0.5 mcg/L.||||0.918
73846507|NCT02122380|147239284|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of early insulin secretion between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).||||0.054
73846508|NCT02122380|147239285|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in blood glucose levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).||||0.009
73846509|NCT02122380|147239286|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in the mass of visceral adipose tissue after sitagliptin vs. placebo. The test was performed with a significance level of 0.05 (two sided).||||0.022
73846510|NCT02122380|147239287|SUPERIORITY|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in vascular function between sitagliptin and placebo treatments. The test was performed with a significance level of 0.05 (two sided).||||0.943
73899080|NCT01247298|147329398|OTHER||Kaplan Meier Estimate|82.0|||||TWO_SIDED||||||||Kaplan Meier Estimates of Progression Free Survival (PFS)|||||
73846511|NCT02465931|147239306|OTHER|||||||0.89|||||||t-test, 1 sided|||||||0.89
73846512|NCT03423602|147239309|NON_INFERIORITY|Based on a Meta-Analysis of a focused systematic literature review from a comparable patient population, the estimated major vascular access site complication rate or PGsafety for the conservative Random Effect Model is 0.125 with a 95% Confidence Interval of 0.09 to 0.17. Given that the upper bound was 0.17 this justified the use of 0.13 as a valid PGsafety plus a non-inferiority margin of 0.04 yielding an overall non-inferiority limit (NLs) of 0.17 for Safety. Study power is greater than 90%|Wilson's exact test|0.0487|||<|0.0001|ONE_SIDED|95.0||0.0487|||Wilson's exact test|All 75 enrolled subjects, regardless of their enrolment status at 1-month post implantation, including all reported safety data where included.||"The test for non-inferiority for safety was based on a one-sided test (at the 0.025 significance level) for a binomial proportion with hypotheses:~H0s: Psafety ≥ NLs versus H1s: Psafety \< NLs Where: Psafety is the actual proportion of device related major vascular access site complications within the study population; and NLs is the non-inferiority limit for proportion of expected major vascular access site complications associated with cut-down and suture closure."||0.0487||<.0001
73846513|NCT02136914|147239325|SUPERIORITY||Least Squares Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.3||0.0009|TWO_SIDED|95.0|-12.5|-3.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||46 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.||-3.3|-12.5|0.0009
73846514|NCT02136914|147239326|SUPERIORITY||Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|2.7||0.0008|TWO_SIDED|95.0|-14.7|-4.0|||Linear Mixed Model w/ Repeated Measures|||||-4.0|-14.7|0.0008
73846515|NCT02136914|147239327|SUPERIORITY||Least Squares Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|0.612|<|0.0001|TWO_SIDED|95.0|1.53|3.96||Change from Baseline in ON time without troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures|||||3.96|1.53|<0.0001
73846516|NCT02136914|147239327|SUPERIORITY||Least Squares Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.634||0.0007|TWO_SIDED|95.0|0.96|3.47||Change from Baseline in ON time without troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures|||||3.47|0.96|0.0007
73899081|NCT02650921|147329422|SUPERIORITY||Difference in Responder Rate|64.7|||<|0.0001|TWO_SIDED|95.0|53.3|76.1|||McNemar|||||76.1|53.3|<0.0001
73846517|NCT02136914|147239327|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.373||0.0171|TWO_SIDED|95.0|-1.64|-0.16||Change from Baseline in OFF time at Week 12.|Linear Mixed Model w/ Repeated Measures|||||-0.16|-1.64|0.0171
73899082|NCT02650921|147329423|SUPERIORITY||Difference in Responder Rate|72.3|||<|0.0001|TWO_SIDED|95.0|61.9|82.7|||McNemar|||||82.7|61.9|<0.0001
73899083|NCT02650921|147329424|SUPERIORITY||Difference in Responder Rate|57.3|||<|0.0001|TWO_SIDED|95.0|44.8|69.8|||McNemar|||||69.8|44.8|<0.0001
74022545|NCT01587950|147597590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.75||||0.2784|TWO_SIDED|95.0|-6.42|21.93|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.93|-6.42|0.2784
74022546|NCT01587950|147597590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.68||||0.3581|TWO_SIDED|95.0|-7.75|21.12|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.12|-7.75|0.3581
74022547|NCT01587950|147597590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.07||||0.8703|TWO_SIDED|95.0|-14.11|11.97|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||11.97|-14.11|0.8703
74022548|NCT04211337|147597607|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.165|0.475|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|||0.475|0.165|<0.0001
74022549|NCT04211337|147597608|SUPERIORITY||Hazard Ratio (HR)|0.254|||<|0.0001|TWO_SIDED|95.0|0.153|0.423|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|||0.423|0.153|<0.0001
74022550|NCT04211337|147597609|SUPERIORITY||Odds Ratio (OR)|3.7|||<|0.0001|TWO_SIDED|95.0|2.2|6.3||Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib)|Clopper-Pearson method|||||6.3|2.2|<0.0001
74022551|NCT04211337|147597610|SUPERIORITY||Hazard Ratio (HR)|0.275||||0.0004|TWO_SIDED|95.0|0.129|0.587|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).||||0.587|0.129|0.0004
74022552|NCT04211337|147597613|SUPERIORITY||Mean Difference (Final Values)|-0.16|||<|0.0001|TWO_SIDED|95.0|-0.23|-0.1||Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Wilcoxon (Mann-Whitney)|||||-0.10|-0.23|<0.0001
74022553|NCT02847598|147597633|SUPERIORITY||Least squares (LS) mean Difference|-3.4||||0.037|TWO_SIDED|95.0|-6.7|-0.2|||MMRM|||A Mixed Effect Model Repeat Measurement (MMRM) model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||-0.2|-6.7|0.037
74022554|NCT02847598|147597634|SUPERIORITY||LS mean difference|-24.29||||0.015|TWO_SIDED|95.0|-43.7|-4.88|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-4.88|-43.70|0.015
74022555|NCT02847598|147597634|SUPERIORITY||LS mean difference|-33.42|||<|0.001|TWO_SIDED|95.0|-52.71|-14.12|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-14.12|-52.71|<0.001
73846518|NCT02136914|147239327|SUPERIORITY||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.389||0.0406|TWO_SIDED|95.0|-1.58|-0.04||Change from Baseline in OFF time at Week 24.|Linear Mixed Model w/ Repeated Measures|||||-0.04|-1.58|0.0406
73846519|NCT02136914|147239327|SUPERIORITY||Least Squares Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.508||0.0031|TWO_SIDED|95.0|-2.55|-0.53||Change from Baseline in ON time with troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures|||||-0.53|-2.55|0.0031
73846520|NCT02136914|147239327|SUPERIORITY||Least Squares Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|0.526||0.0072|TWO_SIDED|95.0|-2.49|-0.4||Change from Baseline in ON time with troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures|||||-0.40|-2.49|0.0072
73846521|NCT02136914|147239328|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.74||0.6833|TWO_SIDED|95.0|-6.6|4.3||Change from Baseline in MDS-UPDRS at Week 12.|Linear Mixed Model w/ Repeated Measures|||||4.3|-6.6|0.6833
73846522|NCT02136914|147239328|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.58||0.5557|TWO_SIDED|95.0|-5.0|9.2||Change from Baseline in MDS-UPDRS at Week 24.|Linear Mixed Model w/ Repeated Measures|||||9.2|-5.0|0.5557
73846523|NCT02136914|147239329|SUPERIORITY||||||<|0.0001||||||Baseline to Week 12|Cochran-Mantel-Haenszel|||||||<0.0001
74022556|NCT02847598|147597634|SUPERIORITY||LS mean difference|-27.99||||0.001|TWO_SIDED|95.0|-44.55|-11.42|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-11.42|-44.55|0.001
73846524|NCT02136914|147239329|SUPERIORITY|||||||0.1071||||||Baseline to Week 24|Cochran-Mantel-Haenszel|||||||0.1071
73846525|NCT01493089|147239339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.563||95.0|||||Regression, Cox|||||||0.563
73846526|NCT01493089|147239340|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.903||||0.712||95.0|||||Regression, Cox|||||||0.712
73846527|NCT01493089|147239341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.457|TWO_SIDED|95.0|||||Regression, Cox|||||||0.457
73846528|NCT01493089|147239342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.625||95.0|-9.7|15.3|||Regression, Cox|||Sustained partial response||15.3|-9.7|0.625
74022557|NCT02847598|147597637|SUPERIORITY||LS Mean Difference|-9.93||||0.22|TWO_SIDED|95.0|-25.94|6.08|||MMRM|||Week 12: A MMRM model is performed, using treatment group study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||6.08|-25.94|0.220
74022558|NCT02847598|147597637|SUPERIORITY||LS Mean Difference|-8.96||||0.293|TWO_SIDED|95.0|-25.82|7.9|||MMRM|||Week 16: A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||7.90|-25.82|0.293
74022559|NCT02847598|147597637|SUPERIORITY||LS Mean Difference|-15.74||||0.062|TWO_SIDED|95.0|-32.28|0.79|||MMRM|||Week 24: A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||0.79|-32.28|0.062
74022560|NCT02847598|147597638|SUPERIORITY||LS mean difference|-30.36||||0.001|TWO_SIDED|95.0|-48.75|-11.97|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-11.97|-48.75|0.001
74022561|NCT02847598|147597638|SUPERIORITY||LS mean difference|-37.17|||<|0.001|TWO_SIDED|95.0|-55.46|-18.87|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-18.87|-55.46|<0.001
74022562|NCT02847598|147597638|SUPERIORITY||LS mean difference|-26.05||||0.001|TWO_SIDED|95.0|-41.71|-10.4|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-10.40|-41.71|0.001
74022563|NCT02847598|147597644|SUPERIORITY||LS Mean Difference|-1.7||||0.007|TWO_SIDED|95.0|-3.0|-0.5|||MMRM|||A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||-0.5|-3.0|0.007
74022564|NCT02847598|147597646|SUPERIORITY||LS mean difference|-0.16||||0.667|TWO_SIDED|95.0|-0.9|0.58|||MMRM|||A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||0.58|-0.90|0.667
74022565|NCT02848833|147597674|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
74022566|NCT02848833|147597677|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
73846529|NCT01493089|147239342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.755|TWO_SIDED|95.0|-15.0|10.6|||Regression, Cox|||Sustained response||10.6|-15.0|0.755
73846530|NCT01493089|147239342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8||||0.194|TWO_SIDED|95.0|-3.6|17.2|||Regression, Cox|||Sustained total relief||17.2|-3.6|0.194
73846531|NCT01493089|147239343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.501|TWO_SIDED|95.0|-15.0|7.0|||Regression, Cox|||Sustained partial response||7.0|-15.0|0.501
73899084|NCT02650921|147329425|SUPERIORITY||Difference in Responder Rate|45.8|||<|0.0001|TWO_SIDED|95.0|32.3|59.3|||McNemar|||||59.3|32.3|<0.0001
74022567|NCT02848833|147597678|OTHER|Difference before administration versus after administration was analyzed using a paired t-test.|||||<|0.0001|||||||paired t-test|||||||<0.0001
73846532|NCT01493089|147239343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.518|TWO_SIDED|95.0|-17.6|8.2|||Regression, Cox|||Sustained response||8.2|-17.6|0.518
74022568|NCT02848833|147597679|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
74022569|NCT02848833|147597680|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
74022570|NCT04167345|147597682|SUPERIORITY||Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|1.1|2.3|||t-test, 2 sided|||||2.3|1.1|<.0001
74022571|NCT04167345|147597682|SUPERIORITY||Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.1|2.9|||t-test, 2 sided|||||2.9|1.1|<.0001
74022572|NCT04167345|147597684|SUPERIORITY||Mean Difference|2.0||||0.0114|TWO_SIDED|95.0|0.5|3.4|||t-test, 2 sided|||||3.4|0.5|0.0114
74022573|NCT04167345|147597684|SUPERIORITY||Mean Difference|2.3||||0.0009|TWO_SIDED|95.0|1.1|3.5|||t-test, 2 sided|||||3.5|1.1|0.0009
74022574|NCT04068103|147597686|SUPERIORITY|||||||0.98||||||P value \<= 0.35 moves trial to phase III, \>0.35 stops trial for futility. Decision rule calls for early stopping due to futility.|Fisher Exact|||One-sided Fisher's Exact Test of ctDNA clearance by treatment arm.||||0.98
73846533|NCT01493089|147239343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.794|TWO_SIDED|95.0|-11.2|13.1|||Regression, Cox|||Sustained total relief||13.1|-11.2|0.794
73846534|NCT01493089|147239344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.494|TWO_SIDED|95.0|-6.3|11.2|||Regression, Cox|||Sustained partial response||11.2|-6.3|0.494
73846535|NCT01493089|147239344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.751|TWO_SIDED|95.0|-14.7|9.1|||Regression, Cox|||Sustained response||9.1|-14.7|0.751
73846536|NCT01493089|147239344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.69|TWO_SIDED|95.0|-16.4|9.6|||Regression, Cox|||Sustained total relief||9.6|-16.4|0.690
73960046|NCT02477670|147455631|SUPERIORITY||SPCD Weighted OLS z-statistic|0.231||||0.818|TWO_SIDED|95.0|-1.729|2.191|||ANCOVA|||||2.191|-1.729|0.818
74022575|NCT03896581|147597696|SUPERIORITY||Odds Ratio (OR)|11.139|||<|0.001|TWO_SIDED|95.0|5.402|22.969|||Regression, Logistic|||||22.969|5.402|<0.001
74022576|NCT03896581|147597697|SUPERIORITY||Least square (LS) mean difference|-0.326|||<|0.001|TWO_SIDED|95.0|-0.42|-0.233|||ANCOVA|||||-0.233|-0.420|<0.001
74022577|NCT03896581|147597699|SUPERIORITY||Odds Ratio (OR)|30.237|||<|0.001|TWO_SIDED|95.0|12.365|73.94|||Regression, Logistic|||||73.940|12.365|<0.001
74022578|NCT03896581|147597700|SUPERIORITY||LS mean difference|6.037|||<|0.001|TWO_SIDED|95.0|4.386|7.688|||ANCOVA|||||7.688|4.386|<0.001
74022579|NCT03896581|147597701|SUPERIORITY||Odds Ratio (OR)|13.089|||<|0.001|TWO_SIDED|95.0|6.119|27.999|||Regression, Logistic|||||27.999|6.119|<0.001
74022580|NCT00960076|147597732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|95.0|-0.73|-0.31||||||||-0.31|-0.73|
74022581|NCT00960076|147597733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.32|STANDARD_ERROR_OF_MEAN|7.128|||TWO_SIDED|95.0|-37.36|-9.28||||||||-9.28|-37.36|
74022582|NCT00960076|147597734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.18|STANDARD_ERROR_OF_MEAN|4.409|||TWO_SIDED|95.0|-21.86|-4.5||||||||-4.50|-21.86|
74022583|NCT00960076|147597735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.2||||0.0459|TWO_SIDED|95.0|0.2|22.0|||ANCOVA|||||22.0|0.2|0.0459
74084369|NCT02760433|147721936|SUPERIORITY||Risk Difference (RD)|0.203||||0.0029|TWO_SIDED|97.5|0.038|0.353|||Chi-squared|2x2 chi-square test||The ACR20 response rate at Week 12 for the placebo group is estimated to be 20% in this study population .The OKZ ACR20 response rate for 64 mg q2w treatment group at Week 12 is expected to be at least 50%, resulting in an expected difference in ACR20 response rates of 30 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.353|0.038|0.0029
73899085|NCT03400956|147329494|SUPERIORITY||Risk Difference (RD)|0.82|||<|0.0001|TWO_SIDED|95.0|0.72|0.93|||Cochran-Mantel-Haenszel||Number of subjects per treatment: 63 (Vilaprisan) / 33 (Placebo).|Vilaprisan (A1) and Vilaprisan+Placebo (B2) combined vs. Placebo+Vilaprisan (B1) in treatment period 1||0.93|0.72|<.0001
73846537|NCT03012334|147239345|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in Standard Deviation of Lateral Position (SDLP) between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|9.86|||<|0.001|TWO_SIDED|95.0|7.39|12.33||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||12.33|7.39|<.001
73846538|NCT03012334|147239345|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|15.35|||<|0.001|TWO_SIDED|95.0|12.87|17.82||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||17.82|12.87|<0.001
73846539|NCT03012334|147239345|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|21.06|||<|0.001|TWO_SIDED|95.0|18.6|23.52||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||23.52|18.60|<0.001
73846540|NCT03012334|147239345|SUPERIORITY||LS Mean|22.71|||<|0.001|TWO_SIDED|95.0|20.23|25.18|||Mixed Models Analysis|||||25.18|20.23|<0.001
73846541|NCT03012334|147239345|SUPERIORITY||LS Mean|-12.85|||<|0.001|TWO_SIDED|95.0|-15.32|-10.38|||Mixed Models Analysis|||||-10.38|-15.32|<0.001
74022584|NCT00371267|147597744|SUPERIORITY_OR_OTHER||||||<|0.27|TWO_SIDED||||||Mixed Models Analysis|||||||<0.27
74022585|NCT00371267|147597745|SUPERIORITY_OR_OTHER||||||<|0.35|TWO_SIDED||||||Mixed Models Analysis|||||||<0.35
74022586|NCT00371267|147597746|SUPERIORITY_OR_OTHER||||||<|0.74|TWO_SIDED||||||Mixed Models Analysis|||||||<0.74
74084370|NCT02760433|147721937|SUPERIORITY||Risk Difference (RD)|0.176||||0.0021|TWO_SIDED|97.5|0.041|0.281|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 5% in the placebo group and 18% and 21% in 64 mg q4w and q2w OKZ groups, respectively, resulting in an expected difference of 13 and 16 percentage points between respective OKZ groups and placebo.||0.281|0.041|0.0021
73899086|NCT00160667|147329501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||=|0.965|TWO_SIDED|95.0|-12.82|13.41|||ANCOVA||Estimated value is the difference of Least Square Means.|||13.41|-12.82|=0.965
73846542|NCT03012334|147239345|SUPERIORITY||LS Mean|-7.36|||<|0.001|TWO_SIDED|95.0|-9.84|-4.88|||Mixed Models Analysis|||||-4.88|-9.84|<0.001
73846543|NCT03012334|147239345|SUPERIORITY||LS Mean|-1.65||||0.19|TWO_SIDED|95.0|-4.11|0.82|||Mixed Models Analysis|||||0.82|-4.11|0.19
74022587|NCT00371267|147597747|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||0.39
74022588|NCT00371267|147597748|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
74022589|NCT00110305|147597749|SUPERIORITY_OR_OTHER||Differences in response rate|0.5||||0.92|TWO_SIDED|95.0|-10.4|11.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N\[t\]RTIs) used, and baseline viral load as covariate.||||11.3|-10.4|0.92
74022590|NCT00110305|147597749|SUPERIORITY_OR_OTHER||Difference in response rate|-2.3||||0.56|TWO_SIDED|95.0|-13.6|9.0||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||9.0|-13.6|0.56
74022591|NCT00110305|147597749|SUPERIORITY_OR_OTHER||Difference in response rate|-2.8||||0.62|TWO_SIDED|95.0|-14.0|8.4||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||8.4|-14.0|0.62
74022592|NCT00110305|147597749|SUPERIORITY_OR_OTHER||Difference in response rate|-1.5||||0.8|TWO_SIDED|95.0|-10.5|7.5||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||7.5|-10.5|0.80
74022593|NCT00110305|147597750|SUPERIORITY_OR_OTHER||Difference in response rate|-4.8||||0.45|TWO_SIDED|95.0|-17.1|7.6||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N\[t\]RTIs) used, and baseline viral load as covariate.||||7.6|-17.1|0.45
74022594|NCT00110305|147597750|SUPERIORITY_OR_OTHER||Difference in response rate|-4.8||||0.45|TWO_SIDED|95.0|-17.3|7.7||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||7.7|-17.3|0.45
74022595|NCT00110305|147597750|SUPERIORITY_OR_OTHER||Difference in response rate|0.0||||0.99|TWO_SIDED|95.0|-12.9|12.8||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||12.8|-12.9|0.99
74022596|NCT00110305|147597750|SUPERIORITY_OR_OTHER||Differences in response|2.6||||0.63|TWO_SIDED|95.0|-8.1|13.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||13.3|-8.1|0.63
74022597|NCT00110305|147597752|SUPERIORITY_OR_OTHER||Difference in response rate|-2.8||||||95.0|-14.7|9.1||||||||9.1|-14.7|
73846544|NCT03012334|147239346|SUPERIORITY||LS Mean|1.6|||<|0.0001|TWO_SIDED|95.0|1.1744|2.0335|||Mixed Models Analysis|||||2.0335|1.1744|<0.0001
73846545|NCT03012334|147239346|SUPERIORITY||LS Mean|2.3|||<|0.0001|TWO_SIDED|95.0|1.8306|2.6926|||Mixed Models Analysis|||||2.6926|1.8306|<.0001
73846546|NCT03012334|147239346|SUPERIORITY||LS Mean|2.9|||<|0.0001|TWO_SIDED|95.0|2.4239|3.28|||Mixed Models Analysis|||||3.2800|2.4239|<0.0001
73846547|NCT03012334|147239346|SUPERIORITY||LS Mean|3.4|||<|0.0001|TWO_SIDED|95.0|2.9568|3.8193|||Mixed Models Analysis|||||3.8193|2.9568|<0.0001
73846548|NCT03012334|147239346|SUPERIORITY||LS Mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.2137|-1.3546|||Mixed Models Analysis|||||-1.3546|-2.2137|<0.0001
73846549|NCT03012334|147239346|SUPERIORITY||LS Mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5574|-0.6956|||Mixed Models Analysis|||||-0.6956|-1.5574|<0.0001
73846550|NCT03012334|147239346|SUPERIORITY||LS Mean|-0.5||||0.0142|TWO_SIDED|95.0|-0.9642|-0.1081|||Mixed Models Analysis|||||-0.1081|-0.9642|0.0142
73846551|NCT03012334|147239348|SUPERIORITY||LS Mean|-12.6|||<|0.0001|TWO_SIDED|95.0|-18.6895|-6.5006|||Mixed Models Analysis|||||-6.5006|-18.6895|<.0001
74022598|NCT03619213|147597806|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0008|TWO_SIDED|95.0|0.73|0.92|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||0.92|0.73|0.0008
74022599|NCT03619213|147597807|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0085|TWO_SIDED|95.0|0.73|0.95|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||0.95|0.73|0.0085
74022600|NCT03619213|147597808|SUPERIORITY||Rate Ratio (RR)|0.77||||0.0003|TWO_SIDED|95.0|0.67|0.89|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization||Comparison Group: Placebo||0.89|0.67|0.0003
73846552|NCT03012334|147239348|SUPERIORITY||LS Mean|-24.2|||<|0.0001|TWO_SIDED|95.0|-30.3631|-18.1357|||Mixed Models Analysis|||||-18.1357|-30.3631|<.0001
73846553|NCT03012334|147239348|SUPERIORITY||LS Mean|-28.4|||<|0.0001|TWO_SIDED|95.0|-34.442|-22.2897|||Mixed Models Analysis|||||-22.2897|-34.4420|<.0001
73846554|NCT03012334|147239348|SUPERIORITY||LS Mean|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.5068|-24.277|||Mixed Models Analysis|||||-24.2770|-36.5068|<0.0001
73846555|NCT03012334|147239348|SUPERIORITY||LS Mean|17.8|||<|0.0001|TWO_SIDED|95.0|11.7029|23.8908|||Mixed Models Analysis|||||23.8908|11.7029|<.0001
74022601|NCT03619213|147597809|SUPERIORITY||Rate Ratio (RR)|0.77||||0.0017|TWO_SIDED|95.0|0.65|0.9|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization||Comparison Group: Placebo||0.90|0.65|0.0017
73846556|NCT03012334|147239348|SUPERIORITY||LS Mean|6.1||||0.0489|TWO_SIDED|95.0|0.0297|12.2554|||Mixed Models Analysis|||||12.2554|0.0297|0.0489
73846557|NCT03012334|147239348|SUPERIORITY||LS Mean|2.0||||0.5123|TWO_SIDED|95.0|-4.05|8.1021|||Mixed Models Analysis|||||8.1021|-4.0500|0.5123
73846558|NCT03012334|147239348|SUPERIORITY||LS Mean|-26.4|||<|0.0001|TWO_SIDED|95.0|-32.4956|-20.3628|||Mixed Models Analysis|||||-20.3628|-32.4956|<.0001
73846559|NCT03012334|147239348|SUPERIORITY||LS Mean|-37.8|||<|0.0001|TWO_SIDED|95.0|-43.927|-31.7537|||Mixed Models Analysis|||||-31.7537|-43.9270|<.0001
73846560|NCT03012334|147239348|SUPERIORITY||LS Mean|-46.8|||<|0.0001|TWO_SIDED|95.0|-52.8147|-40.7268|||Mixed Models Analysis|||||-40.7268|-52.8147|<.0001
73846561|NCT03012334|147239348|SUPERIORITY||LS Mean|-52.6|||<|0.0001|TWO_SIDED|95.0|-58.649|-46.4682|||Mixed Models Analysis|||||-46.4682|-58.6490|<0.0001
73846562|NCT03012334|147239348|SUPERIORITY||LS Mean|26.1|||<|0.0001|TWO_SIDED|95.0|20.0635|32.1953|||Mixed Models Analysis|||||32.1953|20.0635|<.0001
73846563|NCT03012334|147239348|SUPERIORITY||LS Mean|14.7|||<|0.0001|TWO_SIDED|95.0|8.6325|20.804|||Mixed Models Analysis|||||20.8040|8.6325|<.0001
73846564|NCT03012334|147239348|SUPERIORITY||LS Mean|5.8||||0.0605|TWO_SIDED|95.0|-0.256|11.8317|||Mixed Models Analysis|||||11.8317|-0.2560|0.0605
73846565|NCT03012334|147239349|SUPERIORITY||LS Mean|-4.5|||<|0.001|TWO_SIDED|95.0|-6.14|-2.85|||Mixed Models Analysis|||||-2.85|-6.14|<0.001
73846566|NCT03012334|147239349|SUPERIORITY||LS Mean|-6.9|||<|0.001|TWO_SIDED|95.0|-8.58|-5.28|||Mixed Models Analysis|||||-5.28|-8.58|<0.001
73846567|NCT03012334|147239349|SUPERIORITY||LS Mean|-8.9|||<|0.001|TWO_SIDED|95.0|-10.52|-7.23|||Mixed Models Analysis|||||-7.23|-10.52|<0.001
73846568|NCT03012334|147239349|SUPERIORITY||LS Mean|-11.2|||<|0.001|TWO_SIDED|95.0|-12.81|-9.51|||Mixed Models Analysis|||||-9.51|-12.81|<0.001
73846569|NCT03012334|147239349|SUPERIORITY||LS Mean|6.7|||<|0.001|TWO_SIDED|95.0|5.02|8.31|||Mixed Models Analysis|||||8.31|5.02|<0.001
73846570|NCT03012334|147239349|SUPERIORITY||LS Mean|4.2|||<|0.001|TWO_SIDED|95.0|2.58|5.88|||Mixed Models Analysis|||||5.88|2.58|<0.001
73846571|NCT03012334|147239349|SUPERIORITY||LS Mean|2.3|||<|0.007|TWO_SIDED|95.0|0.64|3.93|||Mixed Models Analysis|||||3.93|0.64|<0.007
73846572|NCT03012334|147239350|SUPERIORITY||LS Mean|1.439|||<|0.0001|TWO_SIDED|95.0|1.2198|1.6583|||Mixed Models Analysis|||||1.6583|1.2198|<0.0001
74022602|NCT03619213|147597810|SUPERIORITY||Rate Ratio (RR)|1.11||||0.0086|TWO_SIDED|95.0|1.03|1.21||The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score, stratified by T2DM status at randomisation.|Win Ratio|Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.|The composite of change from baseline in KCCQ Total Symptom Score at 8 months, or death before 8 months.|Comparison Group: Placebo||1.21|1.03|0.0086
74022603|NCT03619213|147597811|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1678|TWO_SIDED|95.0|0.74|1.05|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||1.05|0.74|0.1678
74022604|NCT03619213|147597812|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.3425|TWO_SIDED|95.0|0.83|1.07|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||1.07|0.83|0.3425
74022605|NCT02073487|147597815|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
74022606|NCT02886702|147597818|EQUIVALENCE|90% confidence interval on the difference between the proportions to be within \[-20%, +20%\].|Risk Difference (RD)|-4.5||||||90.0|-12.6|3.6||p-value not calculated|Yates' corrected confidence interval|||||3.6|-12.6|
74022607|NCT02886702|147597818|SUPERIORITY|Last Observation Carried Forward (LOCF) for missing efficacy values||||||0.352|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.3520
74022608|NCT02886702|147597819|SUPERIORITY|||||||0.8105|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.8105
74022609|NCT02886702|147597819|SUPERIORITY|||||||0.0613|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.0613
74022610|NCT02886702|147597820|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||1.0000
74022611|NCT02886702|147597820|SUPERIORITY|||||||0.0712|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.0712
74022612|NCT00054847|147597821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.82|TWO_SIDED|95.0|0.62|1.84||Multiple logistic regression analysis was used to adjust for stratification factors and characteristics that were potentially predictive of graft patency. We also performed prespecified subgroup analyses and assessed treatment subgroup interaction.|Chi-squared|We performed as-treated and per-protocol analyses \& multiple imputations as sensitivity analyses to the intent-to-treat analysis on primary end point.||The study was designed to have 90% power to detect 1-year patency rates of 92% in radial artery vs 83% in saphenous vein grafts, with a 2-sided type I error of 5%and an expected 1-year catheterization completion rate of 65%.||1.84|.62|.82
74022613|NCT00054847|147597822|SUPERIORITY_OR_OTHER|||||||0.61|||||||Chi-squared|||||||.61
73846573|NCT03012334|147239350|SUPERIORITY||LS Mean|2.018|||<|0.0001|TWO_SIDED|95.0|1.7981|2.238|||Mixed Models Analysis|||||2.2380|1.7981|<0.0001
73846574|NCT03012334|147239350|SUPERIORITY||LS Mean|2.572|||<|0.0001|TWO_SIDED|95.0|2.3536|2.7909|||Mixed Models Analysis|||||2.7909|2.3536|<0.0001
73846575|NCT03012334|147239350|SUPERIORITY||LS Mean|2.553|||<|0.0001|TWO_SIDED|95.0|2.3331|2.773|||Mixed Models Analysis|||||2.7730|2.3331|<0.0001
73899087|NCT00160667|147329501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|||=|0.825|TWO_SIDED|95.0|-11.69|14.65|||ANCOVA||Estimated value is the difference of Least Square Means.|||14.65|-11.69|=0.825
73899088|NCT01779219|147329517|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Fisher's exact test (two-tailed)|Fisher Exact|||||||1.0
73899089|NCT01779219|147329518|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
73846576|NCT03012334|147239350|SUPERIORITY||LS Mean|-1.114|||<|0.0001|TWO_SIDED|95.0|-1.3333|-0.8948|||Mixed Models Analysis|||||-0.8948|-1.3333|<0.0001
73846577|NCT03012334|147239350|SUPERIORITY||LS Mean|-0.535|||<|0.0001|TWO_SIDED|95.0|-0.7549|-0.3151|||Mixed Models Analysis|||||-0.3151|-0.7549|<0.0001
73899090|NCT01779219|147329519|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total length of hospital stay||||0.16
73846578|NCT03012334|147239350|SUPERIORITY||LS Mean|0.019||||0.8629|TWO_SIDED|95.0|-0.1995|0.2379|||Mixed Models Analysis|||||0.2379|-0.1995|0.8629
73899091|NCT01779219|147329519|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Length of the preoperative hospital stay||||0.73
73899092|NCT01779219|147329519|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Length of the postoperative hospital stay||||1.0
73899093|NCT01779219|147329520|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total OR time||||<0.001
73899094|NCT01779219|147329520|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Time of preoperative preparations||||0.004
74022614|NCT00054847|147597823|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>.99
74022615|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.36|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-21.96|15.24|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 1||15.24|-21.96|
74022616|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.81|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-30.01|6.4|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg versus Placebo Day 1||6.40|-30.01|
74022617|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-25.65|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-42.99|-8.32|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 1||-8.32|-42.99|
74022618|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.74|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-5.06|34.53|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 28||34.53|-5.06|
74022619|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.22|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-14.64|23.08|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg vs Placebo Day 28||23.08|-14.64|
73846579|NCT03012334|147239352|SUPERIORITY||LS Mean|0.18||||0.0002|TWO_SIDED|95.0|0.0849|0.2746|||Mixed Models Analysis|||||0.2746|0.0849|0.0002
73846580|NCT03012334|147239352|SUPERIORITY||LS Mean|0.303|||<|0.0001|TWO_SIDED|95.0|0.2082|0.3985|||Mixed Models Analysis|||||0.3985|0.2082|<.0001
73846581|NCT03012334|147239352|SUPERIORITY||LS Mean|0.372|||<|0.0001|TWO_SIDED|95.0|0.277|0.4662|||Mixed Models Analysis|||||0.4662|0.2770|<.0001
73846582|NCT03012334|147239352|SUPERIORITY||LS Mean|0.603|||<|0.0001|TWO_SIDED|95.0|0.508|0.6983|||Mixed Models Analysis|||||0.6983|0.5080|<.0001
73846583|NCT03012334|147239352|SUPERIORITY||LS Mean|-0.423|||<|0.0001|TWO_SIDED|95.0|-0.5183|-0.3286|||Mixed Models Analysis|||||-0.3286|-0.5183|<.0001
73846584|NCT03012334|147239352|SUPERIORITY||LS Mean|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.3949|-0.2047|||Mixed Models Analysis|||||-0.2047|-0.3949|<0.0001
73846585|NCT03012334|147239352|SUPERIORITY||LS Mean|-0.232|||<|0.0001|TWO_SIDED|95.0|-0.3261|-0.137|||Mixed Models Analysis|||||-0.1370|-0.3261|<0.0001
73846586|NCT01073293|147239358|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.86|1.05|||ANOVA|||Anti-HPV 6||1.05|0.86|<0.001
73846587|NCT01073293|147239358|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11||1.07|0.87|<0.001
73899095|NCT01779219|147329520|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Time of the operation (skin-to-skin)"||||0.024
73899096|NCT01402427|147329545|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.28|TWO_SIDED|95.0|-0.011|0.033|||Fisher Exact|||||0.033|-0.011|0.28
73846588|NCT01073293|147239358|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.85|1.04|||ANOVA|||Anti-HPV 16||1.04|0.85|<0.001
73846589|NCT01073293|147239358|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.07|||ANOVA|||Anti-HPV 18||1.07|0.84|<0.001
73846590|NCT01073293|147239358|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.84|1.06|||ANOVA|||Anti-HPV 31||1.06|0.84|<0.001
73846591|NCT01073293|147239358|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.9|||<|0.001|TWO_SIDED|95.0|0.81|1.0|||ANOVA|||Anti-HPV 33||1.00|0.81|<0.001
73846592|NCT01073293|147239358|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.86|1.11|||ANOVA|||Anti-HPV 45||1.11|0.86|<0.001
73846593|NCT01073293|147239358|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||ANOVA|||Anti-HPV 52||1.06|0.85|<0.001
73899097|NCT01402427|147329546|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
73846594|NCT01073293|147239358|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||ANOVA|||Anti-HPV 58||0.99|0.80|<0.001
73846595|NCT01073293|147239363|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.2|||<|0.001|TWO_SIDED|95.0|-0.7|1.4|||Miettinen and Nurminen|||Anti-diphtheria titer \>=0.1 IU/mL||1.4|-0.7|<0.001
73846596|NCT01073293|147239363|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen and Nurminen|||Anti-tetanus titer \>=0.1 IU/mL||1.2|-1.1|<0.001
73846597|NCT01073293|147239364|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||ANOVA|||Anti-PT||1.06|0.85|<0.001
73846598|NCT01073293|147239364|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.9|1.08|||ANOVA|||Anti-FHA||1.08|0.90|<0.001
73846599|NCT01073293|147239364|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.8|1.09|||ANOVA|||Anti-PRN||1.09|0.80|<0.001
73846600|NCT01073293|147239364|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Difference in GMT|0.89||||0.005|TWO_SIDED|95.0|0.72|1.11|||ANOVA|||Anti-FIM 2/3||1.11|0.72|0.005
73899098|NCT01402427|147329547|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73899099|NCT01402427|147329548|SUPERIORITY_OR_OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
73899100|NCT01402427|147329549|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
73899101|NCT01402427|147329550|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
73899102|NCT01402427|147329551|SUPERIORITY_OR_OTHER|||||||0.45|||||||Fisher Exact|||||||0.45
74084371|NCT02760433|147721937|SUPERIORITY||Risk Difference (RD)|0.283|||<|0.0001|TWO_SIDED|97.5|0.139|0.396|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 5% in the placebo group and 18% and 21% in 64 mg q4w and q2w OKZ groups, respectively, resulting in an expected difference of 13 and 16 percentage points between respective OKZ groups and placebo.||0.396|0.139|<0.0001
73846601|NCT01073293|147239365|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 1||0.8|-1.2|<0.001
73846602|NCT01073293|147239365|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 2||0.8|-1.2|<0.001
73846603|NCT01073293|147239365|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-0.8|0.8|||Miettinen and Nurminen|||Poliovirus type 3||0.8|-0.8|<0.001
73846604|NCT00256126|147239367|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73846605|NCT01008618|147239383|SUPERIORITY_OR_OTHER|||||||0.0846|||||||Log Rank|||||||0.0846
73846606|NCT00186628|147239421|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Log Rank|||||||.07
73846607|NCT01076010|147239437|OTHER||25% Quartile (months)|8.0|||||TWO_SIDED|95.0|4.4|12.9||||||||12.9|4.4|
73846608|NCT01076010|147239437|OTHER||50% Quartile (months)|15.2|||||TWO_SIDED|95.0|11.1||DR was only summarized for subjects who had an objective tumor response. Upper limit of confidence interval could not be determined.||||||||11.1|
73846609|NCT01076010|147239437|OTHER||25% Quartile (months)|12.9|||||TWO_SIDED|95.0|5.6||DR was only summarized for subjects who had an objective tumor response. Upper limit of confidence interval could not be determined.||||||||5.6|
73846610|NCT01076010|147239438|OTHER||25% Quartile (months)|3.6|||||TWO_SIDED|95.0|1.9|5.2||||||||5.2|1.9|
73899103|NCT04355728|147329553|SUPERIORITY|||||||0.04|||||||Fisher Exact|||"The null hypothesis is the following: There is no difference in the number of subjects experiencing serious adverse events in the UC-MSC vs control group."||||.04
73846611|NCT01076010|147239438|OTHER||50% Quartile (months)|11.0|||||TWO_SIDED|95.0|7.3|12.7||||||||12.7|7.3|
73846612|NCT01076010|147239438|OTHER||75% Quartile (months)|20.9|||||TWO_SIDED|95.0|16.5||For the subjects in each treatment arm, PFS is calculated from the first dose date of the respective study drugs. Upper limit of confidence interval could not be determined.||||||||16.5|
73846613|NCT01076010|147239438|OTHER||25% Quartile (months)|7.2|||||TWO_SIDED|95.0|3.5|9.2||||||||9.2|3.5|
73846614|NCT01076010|147239439|OTHER||25% Quartile (months)|8.2|||||TWO_SIDED|95.0|6.0|12.1||||||||12.1|6.0|
73846615|NCT01076010|147239439|OTHER||50% Quartile (months)|21.6|||||TWO_SIDED|95.0|17.0|27.6||||||||27.6|17.0|
73846616|NCT01076010|147239439|OTHER||75% Quartile (months)|30.7|||||TWO_SIDED|95.0|28.8||For the subjects in each treatment arm, OS is calculated from the first dose date of the respective study drugs. Upper limit of confidence interval could not be determined.||||||||28.8|
73846617|NCT03767881|147239457|NON_INFERIORITY|The upper limit of a 97.8% confidence limit of the mean days to resolution of acute cholecystitis is compared to a Performance Goal of 3.5 days.|Mean Difference (Final Values)|3.5|||||ONE_SIDED|97.8||10.78|||t-test, 1 sided|||||10.78||
73846618|NCT03767881|147239458|NON_INFERIORITY|The upper limit of a 99.7% confidence limit of the proportion of patients with reintervention, including migration and occlusion, is compared to a Performance Goal of 46.2%.|Performance Goal|16.7|||||ONE_SIDED|99.7||42.0|||1-sided Clopper-Pearson 99.7% CI|||||42.0||
73846619|NCT02797821|147239504|OTHER||Least Squares (LS) Means Difference|-1.88|||<|0.0001|TWO_SIDED|95.0|-2.544|-1.216||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥median vs \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the previous comparison at a significance level of 0.05 (p-value \<0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values \<0.05).||-1.216|-2.544|<0.0001
73846620|NCT02797821|147239504|OTHER||LS Means Difference|-1.193||||0.0008|TWO_SIDED|95.0|-1.805|-0.581||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥median vs \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the first comparison at a significance level of 0.05 (p-value \<0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values \<0.05).||-0.581|-1.805|0.0008
73846621|NCT02797821|147239505|OTHER||LS Means Difference|-34.047||||0.0128|TWO_SIDED|95.0|-60.171|-7.922||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥ median versus \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.||||-7.922|-60.171|0.0128
73846622|NCT02797821|147239505|OTHER||LS Means Difference|-29.492||||0.0239|TWO_SIDED|95.0|-54.723|-4.261||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥ median versus \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.||||-4.261|-54.723|0.0239
73899104|NCT04355728|147329562|SUPERIORITY||Hazard Ratio (HR)|0.289||||0.0307|TWO_SIDED|95.0|0.088|0.948|||Log Rank||Censoring was limited to dropout from study, and the event of interest was recovery. In the case of death, the patient's time to recovery was censored at the end of study observation; thus the patient remained in the risk set for all KM estimations.|"The null hypothesis is the following: There is no difference in Time to Recovery up to 31 days post infusion between the UC-MSC group and control group. Time to recovery was estimated in each group with Kaplan-Meier survival estimates. Log-rank tests were used to compare hazards between groups."||0.948|0.088|0.0307
73899105|NCT04355728|147329563|SUPERIORITY|||||||0.0563|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.||||.0563
73899106|NCT04355728|147329564|SUPERIORITY|||||||0.0563|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.||||.0563
73899107|NCT04355728|147329595|SUPERIORITY|||||||0.0356|||||||Wilcoxon (Mann-Whitney)|||||||0.0356
73899108|NCT04355728|147329596|SUPERIORITY|||||||0.0215|||||||Wilcoxon (Mann-Whitney)|||||||0.0215
73899109|NCT04355728|147329597|SUPERIORITY||Mean Difference (Net)|-3498.0|STANDARD_DEVIATION|3078.2||0.021|TWO_SIDED|95.0|-6404.7|-591.2|||t-test, 2 sided|||||-591.2|-6404.7|0.0210
73899110|NCT04355728|147329599|SUPERIORITY|||||||0.48|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 3 days post first infusion."||||0.48
73899111|NCT04355728|147329599|SUPERIORITY|||||||0.41|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 3 days post first infusion."||||0.41
73899112|NCT04355728|147329600|SUPERIORITY|||||||1|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 6 days post first infusion."||||1.00
73899113|NCT04355728|147329600|SUPERIORITY|||||||1|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (Class II) status and treatment group at 6 days post first infusion."||||1.00
73899114|NCT04355728|147329601|SUPERIORITY|||||||0.44|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 14 days post first infusion."||||0.44
73899115|NCT04355728|147329601|SUPERIORITY|||||||0.5238|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 14 days post first infusion."||||0.5238
73899116|NCT03603509|147329643|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: HAI Day 28 - HAI Day 0 for Fluad = HAI Day 28 - HAI Day 0 for Fluzone Alternative Hypothesis: HAI Day 28 - HAI Day 0 for Fluad NE HAI Day 28 - HAI Day 0 for Fluzone||||0.062
73899117|NCT03603509|147329652|SUPERIORITY|null hypothesis: CMV Fluad sample index = CMV Fluzone sample index at Baseline alternate hypothesis: CMV Fluad sample index not equal to CMV Fluzone sample index at Baseline||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
73899118|NCT02656680|147329657|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U Test||||0.72
73899119|NCT02656680|147329658|SUPERIORITY|||||||0.31|||||||Chi-squared|||Chi square test comparing proportion retained in each condition.||||0.31
73899120|NCT02656680|147329659|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
73899121|NCT02656680|147329660|SUPERIORITY|||||||0.218|||||||ANOVA|||We compared mean percent weight loss from baseline across groups with a one-way ANOVA. One participant became pregnant and thus removed from the analysis. This analysis is exploratory given that this pilot study was not powered to detect weight loss differences between groups.||||0.218
73899122|NCT02656680|147329661|SUPERIORITY|||||||0.421|||||||ANOVA|||||||0.421
73899123|NCT04966910|147329662|SUPERIORITY|||||||0.036||||||This p-value applies to the time x condition interaction variable in a repeated-measure ANOVA for client data.|ANOVA|||Repeated measures ANOVA including a time x condition interaction term to test for differences in slopes by condition for client data.||||0.036
73899124|NCT04966910|147329663|SUPERIORITY|||||||0.226||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA.|ANOVA|||||||.226
73899125|NCT04966910|147329664|SUPERIORITY|||||||0.674||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.674
74084372|NCT02760433|147721938|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.081|=|0.1814|TWO_SIDED|97.5|-0.26|0.11||p-value was greater than the threshold p-value of 0.0125|ANCOVA|||||0.11|-0.26|=0.1814
73899126|NCT04966910|147329665|SUPERIORITY|||||||0.317||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.317
73899127|NCT04966910|147329666|SUPERIORITY|||||||0.741||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.741
73899128|NCT04966910|147329667|SUPERIORITY|||||||0.737||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.737
73899129|NCT04531462|147329677|SUPERIORITY|Null hypothesis: Mean change from baseline in HbA1c after 52 weeks of treatment with empagliflozin 10 mg = mean change from baseline in HbA1c after 52 weeks of treatment with placebo.|Mean Difference (Net)|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.36||Threshold level for statistical significance: α = 0.05 .|Mixed Model Repeated Measures (MMRM)||Empagliflozin 10 mg- Placebo|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) which included fixed classification effects for treatment, gender, baseline renal function, visit and visit-by-treatment interaction, and a linear covariate for baseline HbA1c and age. An unstructured covariance structure was used to model the within patient errors. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.||-0.36|-0.78|<0.0001
73899130|NCT04531462|147329678|OTHER||Mean Difference (Net)|-0.61||||0.231|TWO_SIDED|95.0|-1.61|0.39|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline muscle mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.39|-1.61|0.2310
73899131|NCT04531462|147329679|OTHER||Mean Difference (Net)|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.65|-1.04|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline body fat measurement, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||-1.04|-2.65|<0.0001
73846623|NCT02972996|147239517|OTHER|||||||0.56|||||||ANCOVA|||Values are least-squares means ± SEs (adjusted for the baseline values) from ANCOVA linear mixed model that included covariates of age, baseline (pretreatment values), BMI and weight.||||0.56
73846624|NCT02972996|147239518|OTHER|||||||0.03|||||||ANCOVA|||||||0.03
73846625|NCT03961308|147239536|OTHER|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0734|||||TWO_SIDED|90.0|0.9963|1.1565||||||||1.1565|0.9963|
73846626|NCT03961308|147239537|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0824|||||TWO_SIDED|90.0|1.0169|1.1521||||||||1.1521|1.0169|
73846627|NCT03961308|147239538|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0465|||||TWO_SIDED|90.0|0.9935|1.1023||||||||1.1023|0.9935|
73846628|NCT03710889|147239539|OTHER|Within treatment paired t-tests were used to compare the differences in dynamic indices between Baseline and Month 3 using the Bone-Biopsy Population. If the normality assumption is not satisfied at the 0.01 significance level and visual inspection of the data deems it necessary, Wilcoxon signed-rank test is used. No adjustments for multiplicity were made. A 2-sided p-value \<0.05 was considered statistically significant.|||||<|0.0001|||||||Paired t-test, 2 sided|||||||<0.0001
73846629|NCT04881760|147239546|SUPERIORITY||LS Mean difference (Final Values)|-5.64|||<|0.001|TWO_SIDED|95.0|-7.34|-3.94|||Mixed Models Analysis|||||-3.94|-7.34|<0.001
73846630|NCT04881760|147239546|SUPERIORITY||LS Mean difference (Final Values)|-10.45|||<|0.001|TWO_SIDED|95.0|-12.21|-8.7|||Mixed Models Analysis|||||-8.70|-12.21|<0.001
73899132|NCT04531462|147329680|OTHER||Mean Difference (Net)|-0.53||||0.1632|TWO_SIDED|95.0|-1.28|0.22|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline lean body mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.22|-1.28|0.1632
73899133|NCT04531462|147329681|OTHER||Mean Difference (Net)|-0.63||||0.0384|TWO_SIDED|95.0|-1.23|-0.03|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline total body water, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||-0.03|-1.23|0.0384
73899134|NCT04531462|147329682|OTHER||Mean Difference (Net)|-0.03||||0.1975|TWO_SIDED|95.0|-0.07|0.01|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline bone mineral content, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.01|-0.07|0.1975
73846631|NCT04881760|147239546|SUPERIORITY||LS Mean difference (Final Values)|-12.25|||<|0.001|TWO_SIDED|95.0|-14.42|-10.08|||Mixed Models Analysis|||||-10.08|-14.42|<0.001
73846632|NCT04881760|147239546|SUPERIORITY||LS Mean difference (Final Values)|-15.1|||<|0.001|TWO_SIDED|95.0|-16.9|-13.3|||Mixed Models Analysis|||||-13.30|-16.90|<0.001
73846633|NCT04881760|147239546|SUPERIORITY||LS Mean difference (Final Values)|-16.72|||<|0.001|TWO_SIDED|95.0|-18.86|-14.58|||Mixed Models Analysis|||||-14.58|-18.86|<0.001
73846634|NCT04881760|147239546|SUPERIORITY||LS Mean difference (Final Values)|-15.85|||<|0.001|TWO_SIDED|95.0|-17.57|-14.13|||Mixed Models Analysis|||||-14.13|-17.57|<0.001
73899135|NCT04531462|147329683|OTHER||Mean Difference (Net)|-0.081||||0.3725|TWO_SIDED|95.0|-0.259|0.098|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) which included baseline skeletal muscle index, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.098|-0.259|0.3725
73899136|NCT04531462|147329684|OTHER||Mean Difference (Net)|-0.3||||0.4208|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline grip strength, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.5|-1.1|0.4208
73960047|NCT02477670|147455632|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.04||||0.968|TWO_SIDED|95.0|-2.0|1.92|||ANCOVA|||||1.92|-2.00|0.968
73846635|NCT04881760|147239547|SUPERIORITY||LS Mean difference (Final Values)|-6.57|||<|0.001|TWO_SIDED|95.0|-8.94|-4.2|||Mixed Models Analysis|||||-4.20|-8.94|<0.001
73846636|NCT04881760|147239547|SUPERIORITY||LS Mean difference (Final Values)|-14.21|||<|0.001|TWO_SIDED|95.0|-17.64|-10.78|||Mixed Models Analysis|||||-10.78|-17.64|<0.001
73846637|NCT04881760|147239547|SUPERIORITY||LS Mean difference (Final Values)|-15.72|||<|0.001|TWO_SIDED|95.0|-19.05|-12.4|||Mixed Models Analysis|||||-12.40|-19.05|<0.001
73846638|NCT04881760|147239547|SUPERIORITY||LS Mean difference (Final Values)|-19.62|||<|0.001|TWO_SIDED|95.0|-22.73|-16.51|||Mixed Models Analysis|||||-16.51|-22.73|<0.001
73846639|NCT04881760|147239547|SUPERIORITY||LS Mean difference (Final Values)|-21.78|||<|0.001|TWO_SIDED|95.0|-25.05|-18.51|||Mixed Models Analysis|||||-18.51|-25.05|<0.001
73846640|NCT04881760|147239547|SUPERIORITY||LS Mean difference (Final Values)|-22.11|||<|0.001|TWO_SIDED|95.0|-24.92|-19.31|||Mixed Models Analysis|||||-19.31|-24.92|<0.001
73846641|NCT04881760|147239548|SUPERIORITY||Risk Difference (RD)|33.0|||<|0.001|TWO_SIDED|95.0|17.0|49.0|||Regression, Logistic|||||49|17|<0.001
73846642|NCT04881760|147239548|SUPERIORITY||Risk Difference (RD)|61.0|||<|0.001|TWO_SIDED|95.0|45.0|77.0|||Regression, Logistic|||||77|45|<0.001
73846643|NCT04881760|147239548|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|54.0|81.0|||Regression, Logistic|||||81|54|<0.001
73846644|NCT04881760|147239548|SUPERIORITY||Risk Difference (RD)|74.0|||<|0.001|TWO_SIDED|95.0|63.0|85.0|||Regression, Logistic|||||85|63|<0.001
73846645|NCT04881760|147239548|SUPERIORITY||Risk Difference (RD)|74.0|||<|0.001|TWO_SIDED|95.0|63.0|85.0|||Regression, Logistic|||||85|63|<0.001
73846646|NCT04881760|147239548|SUPERIORITY||Risk Difference (RD)|71.0|||<|0.001|TWO_SIDED|95.0|59.0|82.0|||Regression, Logistic|||||82|59|<0.001
73846647|NCT04881760|147239549|SUPERIORITY||Risk Difference (RD)|37.0|||<|0.001|TWO_SIDED|95.0|20.0|54.0|||Regression, Logistic|||||54|20|<0.001
73846648|NCT04881760|147239549|SUPERIORITY||Risk Difference (RD)|60.0|||<|0.001|TWO_SIDED|95.0|44.0|76.0|||Regression, Logistic|||||76|44|<0.001
73960048|NCT02477670|147455633|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.306||||0.76|TWO_SIDED|95.0|-2.266|1.654|||ANCOVA|||||1.654|-2.266|0.760
73846649|NCT04881760|147239549|SUPERIORITY||Risk Difference (RD)|70.0|||<|0.001|TWO_SIDED|95.0|57.0|83.0|||Regression, Logistic|||||83|57|<0.001
73846650|NCT04881760|147239549|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|62.0|84.0|||Regression, Logistic|||||84|62|<0.001
73846651|NCT04881760|147239549|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|62.0|84.0|||Regression, Logistic|||||84|62|<0.001
73846652|NCT04881760|147239549|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|67.0|84.0|||Regression, Logistic|||||84|67|<0.001
73846653|NCT04881760|147239550|SUPERIORITY||Risk Difference (RD)|22.0|||<|0.001|TWO_SIDED|95.0|11.0|33.0|||Regression, Logistic|||||33|11|<0.001
73846654|NCT04881760|147239550|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.001|TWO_SIDED|95.0|38.0|73.0|||Regression, Logistic|||||73|38|<0.001
73846655|NCT04881760|147239550|SUPERIORITY||Risk Difference (RD)|69.0|||<|0.001|TWO_SIDED|95.0|53.0|85.0|||Regression, Logistic|||||85|53|<0.001
73846656|NCT04881760|147239550|SUPERIORITY||Risk Difference (RD)|80.0|||<|0.001|TWO_SIDED|95.0|66.0|93.0|||Regression, Logistic|||||93|66|<0.001
73846657|NCT04881760|147239550|SUPERIORITY||Risk Difference (RD)|91.0|||<|0.001|TWO_SIDED|95.0|83.0|100.0|||Regression, Logistic|||||100|83|<0.001
73846658|NCT04881760|147239550|SUPERIORITY||Risk Difference (RD)|87.0|||<|0.001|TWO_SIDED|95.0|78.0|96.0|||Regression, Logistic|||||96|78|<0.001
73846659|NCT04881760|147239551|SUPERIORITY||Risk Difference (RD)|18.0||||0.008|TWO_SIDED|95.0|5.0|31.0|||Regression, Logistic|||||31|5|0.008
73846660|NCT04881760|147239551|SUPERIORITY||Risk Difference (RD)|64.0|||<|0.001|TWO_SIDED|95.0|48.0|81.0|||Regression, Logistic|||||81|48|<0.001
73846661|NCT04881760|147239551|SUPERIORITY||Risk Difference (RD)|67.0|||<|0.001|TWO_SIDED|95.0|51.0|84.0|||Regression, Logistic|||||84|51|<0.001
73960049|NCT02477670|147455634|SUPERIORITY||SPCD Weighted OLS z-statistic|1.243||||0.214|TWO_SIDED|95.0|-0.717|3.203|||ANCOVA|||||3.203|-0.717|0.214
73846662|NCT04881760|147239551|SUPERIORITY||Risk Difference (RD)|81.0|||<|0.001|TWO_SIDED|95.0|69.0|94.0|||Regression, Logistic|||||94|69|<0.001
73846663|NCT04881760|147239551|SUPERIORITY||Risk Difference (RD)|82.0|||<|0.001|TWO_SIDED|95.0|71.0|94.0|||Regression, Logistic|||||94|71|<0.001
73846664|NCT04881760|147239551|SUPERIORITY||Risk Difference (RD)|84.0|||<|0.001|TWO_SIDED|95.0|74.0|94.0|||Regression, Logistic|||||94|74|<0.001
73846665|NCT04881760|147239552|SUPERIORITY||Risk Difference (RD)|9.0||||0.029|TWO_SIDED|95.0|1.0|17.0|||Regression, Logistic|||||17|1|0.029
73846666|NCT04881760|147239552|SUPERIORITY||Risk Difference (RD)|27.0|||<|0.001|TWO_SIDED|95.0|11.0|43.0|||Regression, Logistic|||||43|11|<0.001
73846667|NCT04881760|147239552|SUPERIORITY||Risk Difference (RD)|43.0|||<|0.001|TWO_SIDED|95.0|26.0|60.0|||Regression, Logistic|||||60|26|<0.001
73846668|NCT04881760|147239552|SUPERIORITY||Risk Difference (RD)|49.0|||<|0.001|TWO_SIDED|95.0|33.0|66.0|||Regression, Logistic|||||66|33|<0.001
73846669|NCT04881760|147239552|SUPERIORITY||Risk Difference (RD)|67.0|||<|0.001|TWO_SIDED|95.0|51.0|83.0|||Regression, Logistic|||||83|51|<0.001
73846670|NCT04881760|147239552|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|56.0|80.0|||Regression, Logistic|||||80|56|<0.001
73846671|NCT04881760|147239553|SUPERIORITY||Risk Difference (RD)|15.0||||0.002|TWO_SIDED|95.0|6.0|24.0|||Regression, Logistic|||||24|6|0.002
73846672|NCT04881760|147239553|SUPERIORITY||Risk Difference (RD)|53.0|||<|0.001|TWO_SIDED|95.0|36.0|70.0|||Regression, Logistic|||||70|36|<0.001
73846673|NCT04881760|147239553|SUPERIORITY||Risk Difference (RD)|63.0|||<|0.001|TWO_SIDED|95.0|47.0|79.0|||Regression, Logistic|||||79|47|<0.001
73846674|NCT04881760|147239553|SUPERIORITY||Risk Difference (RD)|71.0|||<|0.001|TWO_SIDED|95.0|55.0|87.0|||Regression, Logistic|||||87|55|<0.001
73846675|NCT04881760|147239553|SUPERIORITY||Risk Difference (RD)|75.0|||<|0.001|TWO_SIDED|95.0|62.0|89.0|||Regression, Logistic|||||89|62|<0.001
73846676|NCT04881760|147239553|SUPERIORITY||Risk Difference (RD)|82.0|||<|0.001|TWO_SIDED|95.0|71.0|92.0|||Regression, Logistic|||||92|71|<0.001
73846677|NCT04881760|147239554|SUPERIORITY||LS Mean difference (Final Values)|-6.46|||<|0.001|TWO_SIDED|95.0|-8.36|-4.56|||Mixed Models Analysis|||||-4.56|-8.36|<0.001
73846678|NCT04881760|147239554|SUPERIORITY||LS Mean difference (Final Values)|-11.32|||<|0.001|TWO_SIDED|95.0|-13.34|-9.3|||Mixed Models Analysis|||||-9.30|-13.34|<0.001
73846679|NCT04881760|147239554|SUPERIORITY||LS Mean difference (Final Values)|-13.52|||<|0.001|TWO_SIDED|95.0|-15.99|-11.05|||Mixed Models Analysis|||||-11.05|-15.99|<0.001
73846680|NCT04881760|147239554|SUPERIORITY||LS Mean difference (Final Values)|-16.43|||<|0.001|TWO_SIDED|95.0|-18.41|-14.45|||Mixed Models Analysis|||||-14.45|-18.41|<0.001
73846681|NCT04881760|147239554|SUPERIORITY||LS Mean difference (Final Values)|-18.48|||<|0.001|TWO_SIDED|95.0|-20.93|-16.04|||Mixed Models Analysis|||||-16.04|-20.93|<0.001
73846682|NCT04881760|147239554|SUPERIORITY||LS Mean difference (Final Values)|-17.26|||<|0.001|TWO_SIDED|95.0|-19.11|-15.4|||Mixed Models Analysis|||||-15.40|-19.11|<0.001
73846683|NCT04881760|147239555|SUPERIORITY||LS Mean difference (Final Values)|-7.53|||<|0.001|TWO_SIDED|95.0|-10.18|-4.88|||Mixed Models Analysis|||||-4.88|-10.18|<0.001
73846684|NCT04881760|147239555|SUPERIORITY||LS Mean difference (Final Values)|-15.48|||<|0.001|TWO_SIDED|95.0|-19.35|-11.6|||Mixed Models Analysis|||||-11.60|-19.35|<0.001
73846685|NCT04881760|147239555|SUPERIORITY||LS Mean difference (Final Values)|-17.29|||<|0.001|TWO_SIDED|95.0|-21.19|-13.39|||Mixed Models Analysis|||||-13.39|-21.19|<0.001
73846686|NCT04881760|147239555|SUPERIORITY||LS Mean difference (Final Values)|-21.69|||<|0.001|TWO_SIDED|95.0|-25.25|-18.12|||Mixed Models Analysis|||||-18.12|-25.25|<0.001
73846687|NCT04881760|147239555|SUPERIORITY||LS Mean difference (Final Values)|-24.04|||<|0.001|TWO_SIDED|95.0|-27.72|-20.36|||Mixed Models Analysis|||||-20.36|-27.72|<0.001
73846688|NCT04881760|147239555|SUPERIORITY||LS Mean difference (Final Values)|-24.34|||<|0.001|TWO_SIDED|95.0|-27.4|-21.27|||Mixed Models Analysis|||||-21.27|-27.40|<0.001
73846689|NCT04881760|147239556|SUPERIORITY||LS Mean difference (Final Values)|-2.15|||<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||Mixed Models Analysis|||||-1.50|-2.80|<0.001
73846690|NCT04881760|147239556|SUPERIORITY||LS Mean difference (Final Values)|-3.98|||<|0.001|TWO_SIDED|95.0|-4.66|-3.29|||Mixed Models Analysis|||||-3.29|-4.66|<0.001
73846691|NCT04881760|147239556|SUPERIORITY||LS Mean difference (Final Values)|-4.64|||<|0.001|TWO_SIDED|95.0|-5.46|-3.82|||Mixed Models Analysis|||||-3.82|-5.46|<0.001
73960050|NCT02477670|147455635|SUPERIORITY|||||||0.071|||||||SPCD 1 degree of freedom score test|||||||0.071
74022620|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.65|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-11.18|24.47|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 28||24.47|-11.18|
74022621|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.92|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-28.73|2.9|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of the Placebo arm||2.90|-28.73|
74022622|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.18|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-11.69|22.05|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 10 mg arm||22.05|-11.69|
74022623|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.11|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-13.13|19.36|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 50 mg arm||19.36|-13.13|
74022624|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.39|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|4.47|34.3|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 125 mg arm||34.30|4.47|
74022625|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.225|||||TWO_SIDED|95.0|-0.32|-0.129|||Mixed Models Analysis|||Type 1 Diabetes, Day 1|Intercept estimate was 125.45 and between participant standard deviation was 21.63|-0.129|-0.320|
74022626|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.078|||||TWO_SIDED|95.0|-0.171|0.016|||Mixed Models Analysis|||Type 1 Diabetes, Day 28|Intercept estimate was 125.45 and between participant standard deviation was 21.63|0.016|-0.171|
74084373|NCT02760433|147721938|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.083|=|0.0227|TWO_SIDED|97.5|-0.35|0.02||p-value was greater than the threshold p-value of 0.0125|ANCOVA|||||0.02|-0.35|=0.0227
74022627|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.225|||||TWO_SIDED|95.0|-0.32|-0.129|||Mixed Models Analysis|||Type 2 Diabetes, Day 1|Intercept estimate was 113.23 and between participant standard deviation was 21.63|-0.129|-0.320|
73846692|NCT04881760|147239556|SUPERIORITY||LS Mean difference (Final Values)|-5.66|||<|0.001|TWO_SIDED|95.0|-6.34|-4.99|||Mixed Models Analysis|||||-4.99|-6.34|<0.001
73846693|NCT04881760|147239556|SUPERIORITY||LS Mean difference (Final Values)|-6.35|||<|0.001|TWO_SIDED|95.0|-7.17|-5.53|||Mixed Models Analysis|||||-5.53|-7.17|<0.001
73899137|NCT04531462|147329685|OTHER||Mean Difference (Net)|0.0||||0.9267|TWO_SIDED|95.0|-1.0|0.9|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline 5-time chair stand test, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.9|-1.0|0.9267
74022628|NCT01262898|147597825|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.078||||||95.0|-0.171|0.016|||Mixed Models Analysis|||Type 2 Diabetes, Day 28|Intercept estimate was 113.23 and between participant standard deviation was 21.63|0.016|-0.171|
74022629|NCT00461175|147597892|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.61|||||TWO_SIDED|95.0|0.96|2.7|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, breastfeeding at time of insertion and parity status.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.||2.70|0.96|
74022630|NCT00461175|147597892|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.65|||||TWO_SIDED|95.0|0.99|2.78|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, time since last delivery, experience of the inserting health care provider.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.||2.78|0.99|
74022631|NCT00461175|147597893|SUPERIORITY_OR_OTHER||Pearl Index|0.06|||||TWO_SIDED|95.0|0.04|0.09||||||||0.09|0.04|
74022632|NCT00461175|147597893|SUPERIORITY_OR_OTHER||Pearl Index|0.52|||||TWO_SIDED|95.0|0.42|0.64||||||||0.64|0.42|
73846694|NCT04881760|147239556|SUPERIORITY||LS Mean difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-6.59|-5.32|||Mixed Models Analysis|||||-5.32|-6.59|<0.001
73846695|NCT04881760|147239557|SUPERIORITY||LS Mean difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.42|-1.57|||Mixed Models Analysis|||||-1.57|-3.42|<0.001
73846696|NCT04881760|147239557|SUPERIORITY||LS Mean difference (Final Values)|-5.42|||<|0.001|TWO_SIDED|95.0|-6.81|-4.03|||Mixed Models Analysis|||||-4.03|-6.81|<0.001
73846697|NCT04881760|147239557|SUPERIORITY||LS Mean difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-7.23|-4.67|||Mixed Models Analysis|||||-4.67|-7.23|<0.001
73846698|NCT04881760|147239557|SUPERIORITY||LS Mean difference (Final Values)|-7.4|||<|0.001|TWO_SIDED|95.0|-8.62|-6.18|||Mixed Models Analysis|||||-6.18|-8.62|<0.001
73846699|NCT04881760|147239557|SUPERIORITY||LS Mean difference (Final Values)|-8.3|||<|0.001|TWO_SIDED|95.0|-9.55|-7.05|||Mixed Models Analysis|||||-7.05|-9.55|<0.001
73846700|NCT04881760|147239557|SUPERIORITY||LS Mean difference (Final Values)|-8.42|||<|0.001|TWO_SIDED|95.0|-9.49|-7.35|||Mixed Models Analysis|||||-7.35|-9.49|<0.001
73846701|NCT04881760|147239558|SUPERIORITY||LS Mean difference (Final Values)|-2.82||||0.022|TWO_SIDED|95.0|-5.23|-0.41|||Mixed Models Analysis|||||-0.41|-5.23|0.022
73899138|NCT04175509|147329688|SUPERIORITY|||||||0.378|||||||t-test, 2 sided|||||||.378
74084374|NCT02760433|147721939|SUPERIORITY||Risk Difference (RD)|0.164|||||TWO_SIDED|97.5|0.02|0.278||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made||||||0.278|0.020|
74022633|NCT00461175|147597893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16|||||TWO_SIDED|95.0|0.1|0.25|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, and parity.|||0.25|0.10|
74022634|NCT00331760|147597895|SUPERIORITY|||||||0.12|||||||Chi-squared|||A sample size of 42 patients provides 64% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 25%.||||0.12
74022635|NCT00331760|147597895|SUPERIORITY|||||||0.043|||||||Chi-squared|||A sample size of 42 patients provides 88% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 20%.||||0.043
74022636|NCT02514044|147597903|OTHER|"We also performed normalization by calculating the dependent variable as the percentage of change (proportional change) as it follows; (1) (post-active values - pre-active values)/ (pre-active values) and (2) (post-placebo values - pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test."||||||0.008|||||||t-test, 2 sided|||We tested normality using the Kolmogorov-Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.||||0.008
74022637|NCT02514044|147597904|OTHER|"We also performed normalization by calculating the dependent variable as the percentage of change (proportional change) as it follows; (1) (post-active values - pre-active values)/ (pre-active values) and (2) (post-placebo values - pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test."||||||0.02|TWO_SIDED|95.0|||||t-test, 2 sided|||We tested normality using the Kolmogorov-Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.||||0.02
73899139|NCT04175509|147329689|SUPERIORITY|||||||0.753|||||||t-test, 2 sided|||||||.753
73846702|NCT04881760|147239558|SUPERIORITY||LS Mean difference (Final Values)|-7.73|||<|0.001|TWO_SIDED|95.0|-10.32|-5.13|||Mixed Models Analysis|||||-5.13|-10.32|<0.001
73846703|NCT04881760|147239558|SUPERIORITY||LS Mean difference (Final Values)|-9.95|||<|0.001|TWO_SIDED|95.0|-12.47|-7.43|||Mixed Models Analysis|||||-7.43|-12.47|<0.001
73846704|NCT04881760|147239558|SUPERIORITY||LS Mean difference (Final Values)|-11.14|||<|0.001|TWO_SIDED|95.0|-13.72|-8.56|||Mixed Models Analysis|||||-8.56|-13.72|<0.001
73899140|NCT04175509|147329690|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.30
74022638|NCT03093155|147597908|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.001|TWO_SIDED|90.0|0.2|0.49|||Regression, Cox|||||0.49|0.20|<0.001
73899141|NCT04175509|147329691|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
74022639|NCT03093155|147597909|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
74022640|NCT03093155|147597910|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.018|TWO_SIDED|90.0|0.38|0.84|||Regression, Cox|||||0.84|0.38|0.018
74022641|NCT03093155|147597911|SUPERIORITY|||||||0.77|||||||Fisher Exact|||||||0.77
74022642|NCT03093155|147597912|SUPERIORITY|||||||0.068|||||||Fisher Exact|||The RECIST responses were categorized as SD/PD or NA compared to PR or Better as a binary outcome.||||0.068
74084375|NCT02760433|147721939|SUPERIORITY||Risk Difference (RD)|0.174|||||TWO_SIDED|97.5|0.027|0.294||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made||||||0.294|0.027|
74084376|NCT02760433|147721940|SUPERIORITY||Risk Difference (RD)|0.031|||||TWO_SIDED|97.5|-0.052|0.083||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made|||means continuity correction applied because expected cell counts \< 5|||0.083|-0.052|
74084377|NCT02760433|147721940|SUPERIORITY||Risk Difference (RD)|0.065|||||TWO_SIDED|97.5|-0.023|0.134||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made|||means continuity correction applied because expected cell counts \< 5|||0.134|-0.023|
73846705|NCT04881760|147239558|SUPERIORITY||LS Mean difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-14.87|-9.9|||Mixed Models Analysis|||||-9.90|-14.87|<0.001
73846706|NCT04881760|147239558|SUPERIORITY||LS Mean difference (Final Values)|-11.73|||<|0.001|TWO_SIDED|95.0|-14.04|-9.43|||Mixed Models Analysis|||||-9.43|-14.04|<0.001
73846707|NCT04881760|147239559|SUPERIORITY||LS Mean difference (Final Values)|-3.84||||0.01|TWO_SIDED|95.0|-6.77|-0.91|||Mixed Models Analysis|||||-0.91|-6.77|0.010
73846708|NCT04881760|147239559|SUPERIORITY||LS Mean difference (Final Values)|-11.94|||<|0.001|TWO_SIDED|95.0|-15.54|-8.33|||Mixed Models Analysis|||||-8.33|-15.54|<0.001
73846709|NCT04881760|147239559|SUPERIORITY||LS Mean difference (Final Values)|-12.22|||<|0.001|TWO_SIDED|95.0|-16.11|-8.33|||Mixed Models Analysis|||||-8.33|-16.11|<0.001
73846710|NCT04881760|147239559|SUPERIORITY||LS Mean difference (Final Values)|-15.88|||<|0.001|TWO_SIDED|95.0|-19.33|-12.43|||Mixed Models Analysis|||||-12.43|-19.33|<0.001
73846711|NCT04881760|147239559|SUPERIORITY||LS Mean difference (Final Values)|-15.85|||<|0.001|TWO_SIDED|95.0|-19.39|-12.31|||Mixed Models Analysis|||||-12.31|-19.39|<0.001
73846712|NCT04881760|147239559|SUPERIORITY||LS Mean difference (Final Values)|-16.95|||<|0.001|TWO_SIDED|95.0|-20.13|-13.78|||Mixed Models Analysis|||||-13.78|-20.13|<0.001
73846713|NCT01538199|147239572|SUPERIORITY_OR_OTHER|||||||0.04||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|We used a modified intent-to-treat approach with LOCF and unpaired Student's t-test (one-way), comparing the change in total severity score.||||||0.04
73899142|NCT04175509|147329692|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
73899143|NCT04175509|147329693|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.77
73899144|NCT04175509|147329694|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
73899145|NCT04175509|147329695|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
73930696|NCT03238911|147391293|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.0552|TWO_SIDED|95.0|-0.34|0.0|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.00|-0.34|0.0552
73846714|NCT01538199|147239572|SUPERIORITY_OR_OTHER|||||||0.08||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Modified intent-to-treat approach with lost observation carried forward (LOCF) and a two-tailed t-test to compare the change in total severity score.||||||0.08
73846715|NCT01538199|147239572|SUPERIORITY_OR_OTHER|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).||||0.01
73846716|NCT01538199|147239572|SUPERIORITY_OR_OTHER|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).||||0.02
73846717|NCT01538199|147239572|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||By means of a paired t-test we tested the significance of the change in the mean HAM-D17 total score (from baseline) to week 8. Although the primary comparison was with the last assessment (week 8). A last observation carried forward (LOCF) was also performed to account for one missing value at week 8.||||0.004
73899146|NCT00711516|147329730|SUPERIORITY_OR_OTHER||Median Difference (Net)|-241.8||||0.7382|TWO_SIDED|95.0|-2470.0|2102.3||The hierarchical testing procedure was employed to control the studywise error rate at 0.05.|Wilcoxon (Mann-Whitney)|The assumption of normality was violated (p-value ≤0.05), therefore the treatment comparison was made using a Wilcoxon rank-sum test.||Using the standardized difference of 1.10, 28 evaluable patients (14 per treatment group) were required to provide 80% power while controlling the 2-sided, Type 1 error rate at 0.05. With an estimated 25% attrition rate, a total of 38 patients (19 per group) were planned. First analyzed using ANCOVA,the residuals were used to test for normality using Shapiro-Wilk; normality was violated therefore treatment comparison used the Wilcoxon rank sum.||2102.3|-2470.0|0.7382
73846718|NCT01538199|147239575|SUPERIORITY_OR_OTHER|||||||0.18||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|Last observation carried forward (LOCF), one tailed t-test to compare change in QIDS score.||||||0.18
73846719|NCT01538199|147239575|SUPERIORITY_OR_OTHER|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to measure the change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.||||0.01
73899147|NCT00711516|147329731|SUPERIORITY_OR_OTHER||Median Difference (Net)|53.2||||0.1661|TWO_SIDED|95.0|-17.8|136.1|||Wilcoxon (Mann-Whitney)|||The statistical hypothesis for this key secondary efficacy variable was to be tested using the same model as specified for the primary objective efficacy variable (ANCOVA, ANOVA, and Wilcoxon as appropriate). All statistical tests were 2 tailed at the 0.05 level of significance.||136.1|-17.8|0.1661
74084378|NCT02151149|147721941|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9258|TWO_SIDED|95.0|0.84|1.21|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||1.21|0.84|0.9258
73846720|NCT01538199|147239575|SUPERIORITY_OR_OTHER|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test measuring change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.||||0.02
73846721|NCT01147302|147239577|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|8.89||||0.6498|TWO_SIDED|95.0|-24.65|42.42||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of C4d score||42.42|-24.65|0.6498
73846722|NCT01147302|147239577|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|18.56||||0.0768|TWO_SIDED|95.0|1.43|35.68||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of margination score||35.68|1.43|0.0768
73846723|NCT01147302|147239577|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-4.0||||0.6928|TWO_SIDED|95.0|-21.36|13.36||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulitis score||13.36|-21.36|0.6928
73846724|NCT01147302|147239577|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|7.11||||0.0508|TWO_SIDED|95.0|1.23|12.99||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of vasculitis score||12.99|1.23|0.0508
73846725|NCT01147302|147239577|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-4.89||||0.2042|TWO_SIDED|95.0|-11.34|1.56||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulosclerosis score||1.56|-11.34|0.2042
73846726|NCT01147302|147239577|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.22||||0.3322|TWO_SIDED|95.0|-0.61|0.17||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic glomerulopathy score||0.17|-0.61|0.3322
73846727|NCT01147302|147239577|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|5.67||||0.4723|TWO_SIDED|95.0|-7.77|9.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of interstitial fibrosis score||9.11|-7.77|0.4723
73846728|NCT01147302|147239577|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|4.56||||0.5103|TWO_SIDED|95.0|-7.25|16.37||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic vasculitis score||16.37|-7.25|0.5103
73846729|NCT01147302|147239578|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.08||||0.7591|TWO_SIDED|95.0|-0.35|0.51||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20||0.51|-0.35|0.7591
74022643|NCT00619229|147597914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.122|TWO_SIDED|95.0|-0.674|2.55||The criterion for significance (α) was set at one-sided α = 0.025, which means that only an effect in the expected direction was interpreted.|ANCOVA||For exploratory testing an Analysis of Variance-Covariance (ANCOVA) F-test with dependent variable 'difference in visual acuity', fixed factors 'treatment' and 'centre' and Baseline value as a covariate was used.|"The primary goal of the study was to test the following null hypothesis:~H0: μAlprostadil ≤ μPlacebo, against the alternative hypothesis H1: μAlprostadil \> μPlacebo, where μ denotes the mean differences in visual acuity between measurements at 3 months after the end of study drug infusion minus measurements at baseline as assessed as line difference on the standard ETDRS charts."||2.55|-0.674|0.1220
74022644|NCT01075178|147597940|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.81|||||ONE_SIDED|95.0||0.96|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||0.96||
74022645|NCT01075178|147597941|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.8|||||ONE_SIDED|95.0||0.95|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||0.95||
74022646|NCT01075178|147597942|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|1.05|||||ONE_SIDED|95.0||1.64|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||1.64||
74022647|NCT01075178|147597943|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.9|||||ONE_SIDED|95.0||2.19|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||2.19||
74022648|NCT03068715|147598030|SUPERIORITY|We assessed the superiority of active over sham.|||||<|0.001|||||||Mixed Models Analysis|||MADRS scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||<0.001
74022649|NCT03068715|147598031|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.001|||||||Mixed Models Analysis|||HDRS-17 scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||=0.001
74022650|NCT03068715|147598034|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.001|||||||Mixed Models Analysis|||HDRS-17 scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||=0.001
73846730|NCT01147302|147239578|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.01||||0.9533|TWO_SIDED|95.0|-0.44|0.41||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90||0.41|-0.44|0.9533
73846731|NCT01147302|147239579|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|1.45||||0.9046|TWO_SIDED|95.0|-19.34|22.24||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20||22.24|-19.34|0.9046
73846732|NCT01147302|147239579|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|4.68||||0.5895|TWO_SIDED|95.0|-10.19|19.55||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90||19.55|-10.19|0.5895
73846733|NCT01147302|147239580|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|1.56||||0.4558|TWO_SIDED|90.0|-2.0|5.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 20||5.11|-2.00|0.4558
73846734|NCT01147302|147239580|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.24||||0.947|TWO_SIDED|90.0|-6.05|6.52||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 90||6.52|-6.05|0.9470
74084379|NCT02151149|147721948|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.0036|TWO_SIDED|95.0|0.33|0.81|||Stratified Log Rank|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||0.81|0.33|0.0036
73846735|NCT00542178|147239629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.003|TWO_SIDED|95.0|0.51|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 88% to detect a 15% relative reduction with intensive glycemic control as compared with standard glycemic control||0.87|0.51|0.003
73846736|NCT00542178|147239629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.29|TWO_SIDED|95.0|0.84|1.79|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 80% to detect a 20% relative reduction with intensive blood pressure control as compared with standard blood pressure control||1.79|0.84|0.29
73846737|NCT00542178|147239629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.006|TWO_SIDED|95.0|0.42|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 91% to detect a 20% relative reduction with lipid control with a statin and fenofibrate as compared with lipid control with a statin alone||0.87|0.42|0.006
73846738|NCT00542178|147239630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.997||||0.96|TWO_SIDED|95.0|0.901|1.104|||Regression, Cox|||||1.104|0.901|0.96
73846739|NCT00542178|147239630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.5|TWO_SIDED|95.0|0.825|1.099|||Regression, Cox|||||1.099|0.825|0.50
73846740|NCT00542178|147239630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.08|TWO_SIDED|95.0|0.762|1.016|||Regression, Cox|||||1.016|0.762|0.08
73846741|NCT00542178|147239631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.884||||0.0355|TWO_SIDED|95.0|0.788|0.992|||Regression, Cox|||||0.992|0.788|0.0355
73846742|NCT00542178|147239631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.891||||0.17|TWO_SIDED|95.0|0.755|1.051|||Regression, Cox|||||1.051|0.755|0.17
73846743|NCT00542178|147239631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015||||0.86|TWO_SIDED|95.0|0.865|1.19|||Regression, Cox|||||1.190|0.865|0.86
73899148|NCT00711516|147329732|SUPERIORITY_OR_OTHER||Median Difference (Net)|78.9||||0.5774|TWO_SIDED|95.0|-157.8|311.3|||Wilcoxon (Mann-Whitney)|||||311.3|-157.8|0.5774
73899149|NCT00711516|147329733|SUPERIORITY_OR_OTHER||Median Difference (Net)|90.1||||0.861|TWO_SIDED|95.0|-806.7|707.0|||Wilcoxon (Mann-Whitney)|||||707.0|-806.7|0.8610
73899150|NCT00711516|147329734|SUPERIORITY_OR_OTHER||Median Difference (Net)|252.8||||0.6907|TWO_SIDED|95.0|-1066.5|1523.8|||Wilcoxon (Mann-Whitney)|||||1523.8|-1066.5|0.6907
73899151|NCT00711516|147329735|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.2456|TWO_SIDED|95.0|-8.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-8.0|0.2456
73960051|NCT02477670|147455636|SUPERIORITY||SPCD Weighted OLS z-statistic|0.951||||-0.06|TWO_SIDED|95.0|-1.009|2.911|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||2.911|-1.009|-0.06
73960052|NCT02027558|147455657|SUPERIORITY||Mean Difference (Net)|-3.21|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.58|-1.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-1.83|-4.58|<.001
73960053|NCT02027558|147455658|SUPERIORITY||Mean Difference (Net)|-16.23|STANDARD_ERROR_OF_MEAN|6.52||0.013|TWO_SIDED|95.0|-29.02|-2.49|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-2.49|-29.02|0.013
73960054|NCT02027558|147455659|SUPERIORITY||Mean Difference (Net)|-20.46|STANDARD_ERROR_OF_MEAN|8.75||0.019|TWO_SIDED|95.0|-37.63|-3.29|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-3.29|-37.63|0.019
73846744|NCT00542178|147239632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.069|TWO_SIDED|95.0|0.71|1.69|||Regression, Logistic|||||1.69|0.71|0.069
73846745|NCT00542178|147239632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.63|TWO_SIDED|95.0|0.44|1.63|||Regression, Logistic|||||1.63|0.44|0.63
73846746|NCT00542178|147239632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.78|TWO_SIDED|95.0|0.6|1.96|||Regression, Logistic|||||1.96|0.60|0.78
73846747|NCT03449576|147239633|SUPERIORITY||Slope|5.3846|STANDARD_ERROR_OF_MEAN|6.5525||0.4154|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the CAPS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.4154
73846748|NCT03449576|147239634|SUPERIORITY||Slope|0.267397|STANDARD_ERROR_OF_MEAN|0.362521||0.4636|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the SAS-SR score-- with the interaction between Visit (pre/post) and Treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.4636
73846749|NCT03449576|147239635|SUPERIORITY||Slope|2.3355|STANDARD_ERROR_OF_MEAN|6.8791||0.735129|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the PCL score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.735129
73899152|NCT00711516|147329736|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7115|TWO_SIDED|95.0|-8.0|9.0|||Wilcoxon (Mann-Whitney)|||||9.0|-8.0|0.7115
73899153|NCT00711516|147329737|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.0||||0.6103|TWO_SIDED|95.0|-13.0|19.0|||Wilcoxon (Mann-Whitney)|||||19.0|-13.0|0.6103
73899154|NCT00711516|147329738|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.9619|TWO_SIDED|95.0|-18.0|17.0|||Wilcoxon (Mann-Whitney)|||||17.0|-18.0|0.9619
73899155|NCT00711516|147329739|SUPERIORITY_OR_OTHER||Median Difference (Net)|-335.5||||0.4544|TWO_SIDED|95.0|-1270.7|723.3|||Wilcoxon (Mann-Whitney)|||||723.3|-1270.7|0.4544
73846750|NCT03449576|147239636|SUPERIORITY||Slope|-2.64908|STANDARD_ERROR_OF_MEAN|4.76601||0.58|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the AQ score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.580
73846751|NCT03449576|147239637|SUPERIORITY||Slope|1.3946|STANDARD_ERROR_OF_MEAN|5.7193||0.808|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the ITS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.808
73846752|NCT00272792|147239689|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||Compared Week 10 to Baseline.||||<0.001
73846753|NCT00272792|147239689|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 1 sided|||Compared Week 10 to Baseline.||||0.027
73846754|NCT00272792|147239690|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Longitudinal Model|Longitudinal model with blood Phe measurements as the response variable and treatment group, visit, and baseline blood Phe level as covariates.||||||0.009
73846755|NCT00492557|147239721|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% confidence interval (CI), computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|1.7|||||TWO_SIDED|95.0|-3.1|6.5||||||Influenza virus subtype: A/H1N1. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||6.5|-3.1|
73846756|NCT00492557|147239721|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|-4.6|||||TWO_SIDED|95.0|-10.4|1.3||||||Influenza virus subtype: A/H3N2. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||1.3|-10.4|
73846757|NCT00492557|147239721|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|-1.8|||||TWO_SIDED|95.0|-7.8|4.1||||||Influenza virus subtype: B. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||4.1|-7.8|
73846758|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.6|1.04|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.04|0.60|
73846759|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.78|1.13|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.13|0.78|
73846760|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.66|||||TWO_SIDED|95.0|0.51|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.87|0.51|
73846761|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.69|||||TWO_SIDED|95.0|0.55|0.86|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.86|0.55|
73899156|NCT00711516|147329740|SUPERIORITY_OR_OTHER||Median Difference (Net)|6410.3||||0.0193|TWO_SIDED|95.0|1064.7|12087.3|||Wilcoxon (Mann-Whitney)|||||12087.3|1064.7|0.0193
73899157|NCT00711516|147329741|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1704|TWO_SIDED|95.0|-0.1|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.1|0.1704
73899158|NCT00711516|147329742|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.2||||0.0609|TWO_SIDED|95.0|-0.3|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.3|0.0609
73960055|NCT02027558|147455660|SUPERIORITY||Mean Difference (Net)|10.49|STANDARD_ERROR_OF_MEAN|3.04||0.001|TWO_SIDED|95.0|4.53|16.44|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||16.44|4.53|0.001
74022651|NCT03068715|147598035|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.308|||||||t-test, 2 sided|Paired-t test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving active iTBS.||||=0.308
74022652|NCT03068715|147598035|SUPERIORITY|FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas.|||||=|0.778|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving sham iTBS.||||=0.778
74022653|NCT03068715|147598035|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.468|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving active iTBS.||||=0.468
74022654|NCT03068715|147598035|SUPERIORITY|FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas.|||||=|0.486|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving sham iTBS.||||=0.486
74022655|NCT03068715|147598036|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.447|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving active iTBS.||||=0.447
74022656|NCT03068715|147598036|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.115|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving sham iTBS.||||=0.115
74022657|NCT03068715|147598036|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.546|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving active iTBS.||||=0.546
74022658|NCT03068715|147598036|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.607|||||||t-test, 2 sided|||Functional connectivity between lDMN\_rDMN in participants receiving sham iTBS.||||=0.607
74022659|NCT03068715|147598037|SUPERIORITY||P value of the interaction|0.11|||<|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons at this time.|Mixed Models Analysis|We were interested in the interaction between treatment condition and timepoint.||We conducted a linear mixed models analysis, with a focus on the interaction term. No power analysis for this measure because number of participants was determined by other primary study aims.||||<0.05
74022660|NCT03068715|147598038|SUPERIORITY|The SDNN (the standard deviation of the RR intervals) was recorded using ECG. It was not necessary to conduct a power analysis for this measure because the number of participants in the study was based on other considerations (primary treatment goals of the study).|P value of the interaction|0.245|||<|0.05|TWO_SIDED|||||For reporting purposes here the p value was not adjusted for multiple comparisons.|Mixed Models Analysis|We were interested in the significance of the interaction between treatment group and timepoint.||We used a linear mixed models analysis, with the fixed factors being treatment group and timepoint.||||<0.05
74022661|NCT01276288|147598058|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.08|STANDARD_DEVIATION|11.8||0.0092|TWO_SIDED|90.0|97.11|118.07||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||118.07|97.11|0.0092
74084380|NCT02151149|147721949|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3537|TWO_SIDED|95.0|0.54|1.25|||Stratified log-rank test|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||1.25|0.54|0.3537
74084381|NCT02151149|147721950|SUPERIORITY||Risk Ratio (RR)|1.56||||0.0597|TWO_SIDED|95.0|0.971|2.511|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma)..||||2.511|0.971|0.0597
73846762|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.76|||||TWO_SIDED|95.0|0.61|0.94|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.94|0.61|
73899159|NCT00711516|147329743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.0499|TWO_SIDED|95.0|-5.8|0.0||Nominal P-value for treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as covariate.|ANCOVA|||Hierarchical testing procedure was used to control the studywise error rate at 0.05. If treatment was statistically significant on the primary variable, the key secondary variable would be claimed as significant if p-value was \<= 0.05. If primary and key secondary variables were significant subsequent secondary variables following the order presented here would be claimed as significant if their p-values were \<= 0.05. If any were \>0.05 subsequent p-values would be reported as nominal p-values.||-0.0|-5.8|0.0499
73899160|NCT00711516|147329744|SUPERIORITY_OR_OTHER|||||||0.7343||95.0|||||Fisher Exact|||||||0.7343
74022662|NCT01276288|147598058|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.83|STANDARD_DEVIATION|8.9||0.003|TWO_SIDED|90.0|100.14|116.11||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||116.11|100.14|0.0030
74022663|NCT01276288|147598059|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.78|STANDARD_DEVIATION|18.3||0.0199|TWO_SIDED|90.0|88.55|119.29||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||119.29|88.55|0.0199
74022664|NCT01276288|147598059|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.5|STANDARD_DEVIATION|11.3||0.0086|TWO_SIDED|90.0|97.9|118.04||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||118.04|97.90|0.0086
74022665|NCT01276288|147598060|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|96.27|STANDARD_DEVIATION|9.6||0.0008|TWO_SIDED|90.0|89.08|104.05||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||104.05|89.08|0.0008
74022666|NCT01276288|147598061|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|101.77|STANDARD_DEVIATION|17.1||0.0114|TWO_SIDED|90.0|88.63|116.85||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||116.85|88.63|0.0114
74022667|NCT01276288|147598062|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|101.44|STANDARD_DEVIATION|2.9|<|0.0001|TWO_SIDED|90.0|99.06|103.88||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||103.88|99.06|<0.0001
74022668|NCT01276288|147598062|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|104.42|STANDARD_DEVIATION|4.8|<|0.0001|TWO_SIDED|90.0|100.39|108.62||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||108.62|100.39|<0.0001
74022669|NCT01276288|147598062|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|103.19|STANDARD_DEVIATION|8.9||0.0005|TWO_SIDED|90.0|95.93|111.01||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||111.01|95.93|0.0005
74022670|NCT01276288|147598063|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|104.43|STANDARD_DEVIATION|13.1||0.0066|TWO_SIDED|90.0|93.81|116.25||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||116.25|93.81|0.0066
74088242|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.04|-0.4|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.04|<.0001
73846763|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.97|||||TWO_SIDED|95.0|0.75|1.25|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.25|0.75|
73899161|NCT00711516|147329745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.2||||0.1246|TWO_SIDED|95.0|-1.8|14.3||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as a covariate.|ANCOVA|||||14.3|-1.8|0.1246
73899162|NCT00711516|147329746|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.026||||0.7382|TWO_SIDED|95.0|-21.684|19.98|||Wilcoxon (Mann-Whitney)|||||19.980|-21.684|0.7382
74022671|NCT01276288|147598063|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.67|STANDARD_DEVIATION|10.6||0.0012|TWO_SIDED|90.0|94.13|111.97||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||111.97|94.13|0.0012
73899163|NCT00711516|147329747|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.086||||1|TWO_SIDED|95.0|-19.195|25.043|||Wilcoxon (Mann-Whitney)|||||25.043|-19.195|1.000
73846764|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.67|1.07|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.07|0.67|
73846765|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.63|1.02|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.02|0.63|
73846766|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.72|||||TWO_SIDED|95.0|0.53|0.97|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.97|0.53|
73846767|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.64|1.01|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.01|0.64|
73846768|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.7|||||TWO_SIDED|95.0|0.56|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.87|0.56|
73846769|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.65|||||TWO_SIDED|95.0|0.49|0.85|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.85|0.49|
73846770|NCT00492557|147239722|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.71|1.27|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.27|0.71|
73846771|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.68|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.24|0.68|
73846772|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.69|1.2|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.20|0.69|
73899164|NCT00711516|147329748|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.282||||0.8861|TWO_SIDED|95.0|-11.46|14.77|||Wilcoxon (Mann-Whitney)|||||14.770|-11.460|0.8861
73899165|NCT00711516|147329749|SUPERIORITY_OR_OTHER||Median Difference (Net)|11.825||||0.4738|TWO_SIDED|95.0|-12.601|37.987|||Wilcoxon (Mann-Whitney)|||||37.987|-12.601|0.4738
73899166|NCT00711516|147329750|SUPERIORITY_OR_OTHER|||||||0.0573||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||Pearson's correlation coefficient was used to assess the relationship between fMRI variable and performance on the 2-back working memory test||||0.0573
73899167|NCT00711516|147329750|SUPERIORITY_OR_OTHER|||||||0.0754||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.0754
73899168|NCT00711516|147329751|SUPERIORITY_OR_OTHER|||||||0.2727||95.0|||||Pearson's Correlation Coefficient|||||||0.2727
73899169|NCT00711516|147329751|SUPERIORITY_OR_OTHER|||||||0.5671||95.0|||||Pearson's Correlation Coefficient|||||||.5671
73846773|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.47|0.95|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.95|0.47|
73846774|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.77|1.6|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.60|0.77|
73846775|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.08|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.08|0.54|
73846776|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.55|1.09|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.09|0.55|
73846777|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.47|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.12|0.47|
73846778|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.42|1.03|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.03|0.42|
73846779|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.65|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.24|0.65|
73846780|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.59|1.14|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.14|0.59|
73846781|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.61|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.12|0.61|
73899170|NCT00711516|147329752|SUPERIORITY_OR_OTHER|||||||0.1169||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1169
74022672|NCT01276288|147598063|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.42|STANDARD_DEVIATION|5.8|<|0.0001|TWO_SIDED|90.0|97.65|107.42||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||107.42|97.65|<0.0001
74022673|NCT03168867|147598066|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
74022674|NCT01307423|147598112|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.1||||0.0062|TWO_SIDED|95.0|3.5|20.7|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||20.7|3.5|0.0062
74022675|NCT01307423|147598112|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.8||||0.001|TWO_SIDED|95.0|6.1|23.5|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||23.5|6.1|0.0010
74022676|NCT01307423|147598113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.168||||0.0008|TWO_SIDED|95.0|-0.265|-0.071|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.071|-0.265|0.0008
74022677|NCT01307423|147598113|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.217|||<|0.0001|TWO_SIDED|95.0|-0.314|-0.12|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.120|-0.314|<.0001
74022678|NCT01307423|147598114|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1||||0.0002|TWO_SIDED|95.0|7.7|24.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.4|7.7|0.0002
74022679|NCT01307423|147598114|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.4||||0.0063|TWO_SIDED|95.0|3.3|19.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.4|3.3|0.0063
74022680|NCT01307423|147598115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.168||||0.0014|TWO_SIDED|95.0|-0.271|-0.065||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate||||-0.065|-0.271|0.0014
74022681|NCT01307423|147598115|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.219|||<|0.0001|TWO_SIDED|95.0|-0.322|-0.117||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate||||-0.117|-0.322|<.0001
74022682|NCT01307423|147598116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.38||||0.0043|TWO_SIDED|95.0|0.75|4.01||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate||||4.01|0.75|0.0043
74022683|NCT01307423|147598116|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.18||||0.0002|TWO_SIDED|95.0|1.55|4.82||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate||||4.82|1.55|0.0002
74022684|NCT01307423|147598117|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.4||||0.0037|TWO_SIDED|95.0|4.8|24.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.0|4.8|0.0037
74022685|NCT01307423|147598117|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|21.0|||<|0.0001|TWO_SIDED|95.0|11.3|30.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||30.7|11.3|<.0001
74088243|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.08|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.08|<.0001
73899171|NCT00711516|147329752|SUPERIORITY_OR_OTHER|||||||0.1634||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1634
74022686|NCT01307423|147598118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.0||||0.0485|TWO_SIDED|95.0|-10.0|0.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||||-0.0|-10.0|0.0485
74022687|NCT01307423|147598118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.8||||0.0022|TWO_SIDED|95.0|-12.8|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||||-2.8|-12.8|0.0022
74022688|NCT01307423|147598119|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.7696|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||0.6|-0.8|0.7696
74022689|NCT01307423|147598119|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0||||0.0038|TWO_SIDED|95.0|-1.7|-0.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.3|-1.7|0.0038
74022690|NCT01307423|147598120|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-1.6|-0.2|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.2|-1.6|
74022691|NCT01307423|147598120|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-1.4|0.0|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.0|-1.4|
73846782|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.57|1.16|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.16|0.57|
73846783|NCT00492557|147239725|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.27|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.27|0.54|
73846784|NCT04790786|147239731|EQUIVALENCE|Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.||||||||||||Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound based on Bayesian probability.|Bayesian cumulative logistic model|Bayesian cumulative logistic model, Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.||The primary analysis model was a Bayesian cumulative logistic model that adjusted for treatment location (infusion center or ED), age (\<30, 30-39, 40-49, 50-59, 60-69, 70-79, and ≥ 80 years), sex, and time (2-week epochs). Comparisons between individual mAb were based on the relative odds ratio between a given two arms for the primary outcome. An odds ratio for an arm to a comparator \>1 implies improved outcomes. A sliding scale with different levels of equivalence bounds was pre-defined|Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.|||
73846785|NCT02098304|147239744|SUPERIORITY_OR_OTHER||Percentage agreement|72.3|||<|0.001|TWO_SIDED|95.0|59.8|82.7|||Exact binomial test|An exact binomial test was used and an exact 95% Confidence Interval using the Clopper-Pearson method was calculated.||The null hypothesis was of chance agreement (50%) and was tested against a two-sided alternative at the 5% level of significance.||82.7|59.8|<0.001
73899172|NCT00711516|147329753|SUPERIORITY_OR_OTHER|||||||0.0692||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.0692
74022692|NCT01307423|147598121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.91|||||TWO_SIDED|95.0|-7.04|-2.78|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-2.78|-7.04|
74022693|NCT01307423|147598121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.65|||||TWO_SIDED|95.0|-7.78|-3.51|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-3.51|-7.78|
74022694|NCT01307423|147598122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.67|-0.25|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.25|-0.67|<0.0001
74022695|NCT01307423|147598122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.32|-0.74|<0.0001
73899173|NCT00711516|147329753|SUPERIORITY_OR_OTHER|||||||0.8876||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.8876
73899174|NCT00711516|147329754|SUPERIORITY_OR_OTHER|||||||0.603||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.6030
74022696|NCT01307423|147598123|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.12|||||TWO_SIDED|95.0|-0.63|2.87|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||2.87|-0.63|
74022697|NCT01307423|147598123|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.55|||||TWO_SIDED|95.0|0.8|4.31|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||4.31|0.80|
74022698|NCT01307423|147598124|SUPERIORITY_OR_OTHER_LEGACY||LS Means Difference|1.97|||||TWO_SIDED|95.0|0.28|3.65|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||3.65|0.28|
74022699|NCT01307423|147598124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.72|||||TWO_SIDED|95.0|2.02|5.41|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||5.41|2.02|
74022700|NCT01307423|147598125|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.5|||||TWO_SIDED|95.0|10.5|28.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||28.6|10.5|
74022701|NCT01307423|147598125|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|18.2|||||TWO_SIDED|95.0|9.2|27.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||27.2|9.2|
74022702|NCT01307423|147598126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.6|||||TWO_SIDED|95.0|-10.6|-0.5|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||-0.5|-10.6|
74022703|NCT01307423|147598126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.7|||||TWO_SIDED|95.0|-10.8|-0.7|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||-0.7|-10.8|
74022704|NCT01307423|147598127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|||||TWO_SIDED|95.0|-1.0|0.4|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||0.4|-1.0|
74022705|NCT01307423|147598127|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-1.6|-0.2|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.2|-1.6|
74022706|NCT01307423|147598128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|||||TWO_SIDED|95.0|-1.7|-0.3|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.3|-1.7|
74022707|NCT01307423|147598128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.4|0.1|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||0.1|-1.4|
74022708|NCT01307423|147598129|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.07|||||TWO_SIDED|95.0|-7.31|-2.84|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-2.84|-7.31|
74022709|NCT01307423|147598129|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.14|||||TWO_SIDED|95.0|-7.38|-2.89|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-2.89|-7.38|
74022710|NCT01307423|147598130|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.23|||ANCOVA||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.23|-0.70|<0.0001
74022711|NCT01307423|147598130|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46||||0.0001|TWO_SIDED|95.0|-0.69|-0.22|||ANCOVA||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.22|-0.69|0.0001
74022712|NCT01307423|147598131|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.12|||||TWO_SIDED|95.0|-0.68|2.93|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||2.93|-0.68|
74022713|NCT01307423|147598131|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.33|||||TWO_SIDED|95.0|0.52|4.15|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||4.15|0.52|
74022714|NCT01307423|147598132|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-10.2|15.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||15.5|-10.2|
74022715|NCT01307423|147598132|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.0|||||TWO_SIDED|95.0|4.2|29.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||29.8|4.2|
74022716|NCT01307423|147598133|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|-7.8|20.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||20.4|-7.8|
73899175|NCT00711516|147329754|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||<.0001
74022717|NCT01307423|147598133|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-12.6|16.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||16.4|-12.6|
74022718|NCT01307423|147598134|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1|||||TWO_SIDED|95.0|6.4|25.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||25.8|6.4|
74022719|NCT01307423|147598134|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.3|||||TWO_SIDED|95.0|9.6|29.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||29.1|9.6|
74022720|NCT01307423|147598135|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|-6.8|18.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||18.8|-6.8|
74022721|NCT01307423|147598135|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|18.0|||||TWO_SIDED|95.0|5.3|30.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||30.6|5.3|
74022722|NCT01307423|147598136|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.1|25.9|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||25.9|-2.1|
74022723|NCT01307423|147598136|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.3|||||TWO_SIDED|95.0|-9.2|19.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.8|-9.2|
74022724|NCT01307423|147598137|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||||TWO_SIDED|95.0|8.8|26.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||26.8|8.8|
74022725|NCT01307423|147598137|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.4|||||TWO_SIDED|95.0|2.7|20.0|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||20.0|2.7|
74022726|NCT01307423|147598138|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.9|||||TWO_SIDED|95.0|1.3|12.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.5|1.3|
74022727|NCT01307423|147598138|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.8|||||TWO_SIDED|95.0|1.2|12.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.4|1.2|
74022728|NCT01307423|147598139|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.9|||||TWO_SIDED|95.0|-0.4|6.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||6.2|-0.4|
74022729|NCT01307423|147598139|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-0.4|6.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||6.1|-0.4|
73846786|NCT02098304|147239744|SUPERIORITY_OR_OTHER||Cohen's kappa|0.45||||0.001|TWO_SIDED|95.0|0.24|0.66|||Cohen's Kappa||Cohen's kappa is a chance-adjusted measure of agreement. A value of 0 indicates agreement by chance and 1 perfect agreement.|The null hypothesis was of chance agreement (Cohen's kappa of 0) and was tested against a two-sided alternative at the 5% level of significance. The study was powered such that 58 teeth (29 subjects), there would be 95% power to reject the null hypothesis of chance agreement (Cohen's kappa of 0) at the 5% level of significance, given that it was expected to be at least 0.4.||0.66|0.24|0.001
74022730|NCT01307423|147598140|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8|||||TWO_SIDED|95.0|3.2|16.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||16.3|3.2|
74022731|NCT01307423|147598140|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|0.2|12.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||12.3|0.2|
74022732|NCT01307423|147598141|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-4.1|4.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||4.1|-4.1|
74022733|NCT01307423|147598141|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-3.7|4.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||4.8|-3.7|
74084382|NCT00766493|147721951|SUPERIORITY_OR_OTHER||Proportion|0.043|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.021|0.077||Reject H0 if z\<-1.96, or 1-sided p\<0.025.|One Sample Binomial|Significance test was based on a one-sample normal approximation to the binomial test.|The 2-sided 95% CI is reported for descriptive purposes; the statistical hypothesis test is 1-sided.|"This study is designed to test the primary null hypothesis that the composite MAE outcome of all death, stroke, and/or MI when using the GORE Embolic Filter is equal to or higher than a Performance Goal (PG) of 6.4% established from published carotid stenting studies utilizing distal embolic protection, versus the alternative hypothesis that the composite MAE outcome is less than the performance goal.~The sample size was calculated based on 80% power and a 1-sided Type I error rate of 0.025."||0.077|0.021|0.0001
74088244|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.44|-1.14|<.0001
73899176|NCT00711516|147329755|SUPERIORITY_OR_OTHER|||||||0.917||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.9170
73899177|NCT00711516|147329755|SUPERIORITY_OR_OTHER|||||||0.9642||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.9642
74022734|NCT01307423|147598142|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-8.1|12.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.6|-8.1|
74022735|NCT01307423|147598142|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||||TWO_SIDED|95.0|6.3|29.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||29.3|6.3|
74022736|NCT01307423|147598143|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.4|||||TWO_SIDED|95.0|-4.8|23.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||23.5|-4.8|
74022737|NCT01307423|147598143|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.1|||||TWO_SIDED|95.0|-7.2|21.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||21.5|-7.2|
74022738|NCT01307423|147598144|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|-4.8|17.7|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||17.7|-4.8|
74022739|NCT01307423|147598144|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|3.4|27.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||27.1|3.4|
74022740|NCT01307423|147598145|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.5|||||TWO_SIDED|95.0|-3.8|24.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.8|-3.8|
74022741|NCT01307423|147598145|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|4.9|||||TWO_SIDED|95.0|-9.5|19.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.3|-9.5|
74022742|NCT02382133|147598184|SUPERIORITY|comparing nasal and forehead oximetry sensor pressure ulcer incidence|||||=|0.006|||||||Chi-squared|||||||=.006
74022743|NCT00655928|147598185|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
73899178|NCT00711516|147329756|SUPERIORITY_OR_OTHER|||||||0.7813||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.7813
73899179|NCT00711516|147329756|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1560
73899180|NCT00711516|147329757|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.9010
73899181|NCT00711516|147329757|SUPERIORITY_OR_OTHER|||||||0.0135||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.0135
73899182|NCT00711516|147329766|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.841||||0.7053|TWO_SIDED|95.0|-27.778|19.313|||Wilcoxon (Mann-Whitney)|||||19.313|-27.778|0.7053
73899183|NCT00711516|147329767|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.792||||0.5163|TWO_SIDED|95.0|-30.631|16.19|||Wilcoxon (Mann-Whitney)|||||16.190|-30.631|0.5163
73899184|NCT00711516|147329768|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.108||||0.8711|TWO_SIDED|95.0|-14.341|5.498|||Wilcoxon (Mann-Whitney)|||||5.498|-14.341|0.8711
73899185|NCT00711516|147329769|SUPERIORITY_OR_OTHER||Median Difference (Net)|13.855||||0.1825||95.0|-15.357|25.714|||Wilcoxon (Mann-Whitney)|||||25.714|-15.357|0.1825
73899186|NCT00711516|147329770|SUPERIORITY_OR_OTHER||Median Difference (Net)|-323.5||||0.9282|TWO_SIDED|95.0|-9311.0|2375.5|||Wilcoxon (Mann-Whitney)|||||2375.5|-9311.0|0.9282
73899187|NCT00711516|147329771|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||1|TWO_SIDED|95.0|-1069.0|426.0|||Wilcoxon (Mann-Whitney)|||||426.0|-1069.0|1.0000
73899188|NCT00711516|147329772|SUPERIORITY_OR_OTHER||Median Difference (Net)|-82.8||||0.5284|TWO_SIDED|95.0|-788.0|165.5|||Wilcoxon (Mann-Whitney)|||||165.5|-788.0|0.5284
73899189|NCT00711516|147329773|SUPERIORITY_OR_OTHER||Median Difference (Net)|-145.8||||0.8997|TWO_SIDED|95.0|-3151.0|1006.5|||Wilcoxon (Mann-Whitney)|||||1006.5|-3151.0|0.8997
73899190|NCT00711516|147329774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.1||||0.1305|TWO_SIDED|95.0|-58.2|8.0|||ANCOVA|||||8.0|-58.2|0.1305
73899191|NCT01029405|147329784|SUPERIORITY_OR_OTHER||||||<|0.001|||||||2-sided sign test|||||||<0.001
73899192|NCT00924170|147329799|SUPERIORITY||||||<|0.0001|||||||Kaplan Meier|||Published response duration of 15 patients with leukemic adult T cell leukemia treated with Alemtuzumab.||||<0.0001
73899193|NCT00579436|147329813|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
73899194|NCT00579436|147329814|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73899195|NCT00579436|147329815|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
73899196|NCT00579436|147329816|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
73899197|NCT02312882|147329817|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73899198|NCT02025556|147329840|SUPERIORITY||Mean Difference (Final Values)|-2.81|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-4.07|-1.55||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.55|-4.07|< .0001
73899199|NCT02025556|147329840|SUPERIORITY||Mean Difference (Final Values)|-2.64|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-3.9|-1.38||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.38|-3.9|< .0001
73899200|NCT01203852|147329865|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value for one sided t-test of mean change in blood pressure before and after treatment with metoprolol and chlorthalidone were \<0.0001.|t-test, 1 sided|||||||<0.0001
73899201|NCT01203852|147329866|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value for one sided t-test for mean glucose change before and after treatment with chlorthalidone was \<0.0001.|t-test, 1 sided|||Mean glucose change after treatment with chlorthalidone||||<0.0001
73899202|NCT01203852|147329866|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||P-value for one sided t-test for mean glucose change before and after treatment with metoprolol was 0.049.|t-test, 1 sided|||Mean glucose change after treatment with metoprolol||||0.049
73899203|NCT00247611|147329875|SUPERIORITY_OR_OTHER|||||||0.12||||||The p-value was not adjusted for multiple comparisons, and thresholds for significance were 0.05 alpha two tailed.|HLM|||For the ITT sample, the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from was associated with a p-value of 0.12, two-tailed alpha 0.05.||||0.12
73899204|NCT00247611|147329875|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||The p-value was not adjusted for multiple comparisons, and thresholds for significance was 0.05 alpha, two tailed.|HLM|||For the on protocol sample, study arm was associated with perfect ACTG-assessed 3-day ARV adherence at p = 0.024, alpha two-tailed.||||0.024
73899205|NCT00247611|147329876|SUPERIORITY_OR_OTHER||||||>|0.5||95.0||||No adjustments were made.|Generalized Linear Model (GLM)|||For the ITT or OP samples, the significance threshold between groups over time for differential increases in proportion with suppressed (undetectable) viral load was p \> 0.50. The study was underpowered to detect differences in Viral load.||||>0.50
73899206|NCT00247611|147329877|SUPERIORITY_OR_OTHER|||||||0.12||0.0||||The p-value was not adjusted for multiple comparisons and is reported as 0.12 at alpha 0.05 two tailed|HLM|||For the ITT sample (t=586) the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.||||0.12
73899207|NCT00247611|147329877|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||The p-value was not adjusted for multiple comparisons, and is reported as 0.12 at alpha 0.05 two tailed.|HLM|||For the on protocol sample the pattern of increased proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.||||0.12
73899208|NCT00247611|147329878|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||P-value for difference in unemployment rate between On Protocol (OP) sample, and participants excluded from on protocol analysis.||||<0.001
73846787|NCT02852967|147239761|SUPERIORITY|||||||0.6384|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg QD + placebo (n = 23) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.6384
74088245|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18||0.0006|TWO_SIDED|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.98|0.0006
73846788|NCT02852967|147239761|SUPERIORITY|||||||0.6419|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg BID + placebo (n = 22) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.6419
73846789|NCT02852967|147239761|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 400 mg QD + placebo (n = 21) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||> 0.9999
73846790|NCT02852967|147239761|SUPERIORITY|||||||0.3859|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 600 mg (n = 26) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.3859
73846791|NCT02852967|147239761|SUPERIORITY|||||||0.4435|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of all subjects treated with belumosudil (n = 92) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75||||0.4435
73846792|NCT02852967|147239761|SUPERIORITY|||||||0.2721|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg QD + placebo (n = 14) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.2721
73846793|NCT02852967|147239761|SUPERIORITY|||||||0.3577|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg BID+ Placebo (n = 15) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3577
73846794|NCT02852967|147239761|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 500 mg QD + Placebo (n = 17) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||> 0.9999
73846795|NCT02852967|147239761|SUPERIORITY|||||||0.3402|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 600 mg/day (n = 16) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3402
73846796|NCT02852967|147239761|SUPERIORITY|||||||0.3542|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of all subjects treated with belumosudil 200 mg QD + Placebo (n = 62) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3542
73846797|NCT02852967|147239765|SUPERIORITY|||||||0.5728|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.5728
73846798|NCT02852967|147239765|SUPERIORITY|||||||0.1962|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.1962
73846799|NCT02852967|147239765|SUPERIORITY|Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear|||||>|0.9999|||||||Fisher Exact|||||||> 0.9999
73846800|NCT02852967|147239765|SUPERIORITY|||||||0.5583|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.5583
73846801|NCT02852967|147239765|SUPERIORITY|||||||0.2538|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.2538
73846802|NCT02286895|147239775|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-4.0|4.2||||||Based on results from a prior study, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||4.2|-4.0|
73846803|NCT02286895|147239776|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% CI (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-12.2|4.0||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||4.0|-12.2|
73846804|NCT02286895|147239777|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-7.5|2.7||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||2.7|-7.5|
73846805|NCT02286895|147239778|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
73846806|NCT02286895|147239779|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean concentration (GMC) of group receiving rotavirus vaccine/ GMC of group not receiving rotavirus vaccine = 1|geometric mean titer ratio|-0.7|||||TWO_SIDED|95.0|-5.2|3.8||||||||3.8|-5.2|
73846807|NCT02286895|147239780|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||TWO_SIDED|95.0|0.7|1.3||||||||1.3|0.7|
73846808|NCT02286895|147239781|SUPERIORITY||Mean Difference (Net)|17.5|||||TWO_SIDED|95.0|9.7|25.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||25.3|9.7|
73846809|NCT02286895|147239782|SUPERIORITY||Mean Difference (Net)|15.8|||||TWO_SIDED|95.0|8.1|23.4||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||23.4|8.1|
73846810|NCT02286895|147239783|SUPERIORITY||Mean Difference (Net)|25.4|||||TWO_SIDED|95.0|14.6|36.2||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||36.2|14.6|
73846811|NCT02286895|147239784|SUPERIORITY||Mean Difference (Net)|31.1|||||TWO_SIDED|95.0|23.1|39.0||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||39.0|23.1|
73846812|NCT02286895|147239785|SUPERIORITY||Mean Difference (Net)|17.7|||||TWO_SIDED|95.0|12.0|23.5||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||23.5|12.0|
73846813|NCT02286895|147239786|SUPERIORITY||Mean Difference (Net)|52.0|||||TWO_SIDED|95.0|37.7|66.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||66.3|37.7|
73846814|NCT02286895|147239787|SUPERIORITY||geometric mean titer ratio|1.7|||||TWO_SIDED|95.0|1.2|2.4||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||2.4|1.2|
73846815|NCT02286895|147239788|SUPERIORITY||geometric mean titer ratio|2.3|||||TWO_SIDED|95.0|1.7|3.1||||||Null hypothesis: 28 days post-vaccination, geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||3.1|1.7|
73846816|NCT02286895|147239789|SUPERIORITY||geometric mean titer ratio|2.0|||||TWO_SIDED|95.0|1.2|3.3||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||3.3|1.2|
73846817|NCT02286895|147239790|SUPERIORITY||geometric mean titer ratio|4.6|||||TWO_SIDED|95.0|2.4|8.9||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||8.9|2.4|
73846818|NCT02949011|147239794|SUPERIORITY||Median Difference|-29.1|||<|0.0001|TWO_SIDED|95.0|-42.8|-14.6||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The primary analysis of the primary endpoint was a comparison between the baloxavir marboxil and placebo groups.||-14.6|-42.8|<0.0001
73846819|NCT02949011|147239794|SUPERIORITY||Median Difference|-7.7||||0.8347|TWO_SIDED|95.0|-22.7|7.9||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The comparison between the baloxavir marboxil and the oseltamivir groups was conducted as a secondary analysis only if a statistically significant difference was observed in the primary analysis in order to maintain control of overall type I error.||7.9|-22.7|0.8347
73846820|NCT02949011|147239794|SUPERIORITY|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.0008
73846821|NCT02949011|147239794|SUPERIORITY|||||||0.8449||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.8449
73846822|NCT02949011|147239795|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
73899209|NCT00247611|147329878|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||P-value for difference of participants on disability between On Protocol (OP) sample, and participants excluded from on protocol analysis.||||<0.01
73899210|NCT01087788|147329894|SUPERIORITY_OR_OTHER||Difference in Percentages|33.7|||<|0.001|TWO_SIDED|95.0|22.8|44.6||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||44.6|22.8|<0.001
73960056|NCT02027558|147455661|SUPERIORITY||Mean Difference (Net)|4.35|STANDARD_ERROR_OF_MEAN|1.26||0.001|TWO_SIDED|95.0|1.87|6.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||6.83|1.87|0.001
74022744|NCT01976806|147598215|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|||||||Mixed Models Analysis|Compound-symmetry covariance structure with age, sex, BMI, race, baseline pocket depth, baseline RBC DHA level, and intervention group variables|Mean change in pocket depth (3-month follow-up minus baseline) among dental sites with baseline pocket depths \>=5 mm in the DHA intervention group versus the placebo group.|Intent-to-treat basis with a type I error rate of 0.05. The follow-up pocket depth, was assessed in linear mixed effects models with a compound-symmetry covariance structure and age, sex, BMI, race, baseline pocket depth, baseline red blood cell (RBC) DHA level (dichotomized at median), and intervention group as fixed-effect variables.||||<0.05
74022745|NCT04551014|147598234|NON_INFERIORITY|For polypectomy without submucosal injection of EverLiftTM to be considered non-inferior, we calculated that 115 polyps were needed in each group to achieve an alpha value of 0.05, power of 90%, and non-inferiority margin of -10%.||||||0.424|||||||t-test, 2 sided|||||||0.424
74022746|NCT04551014|147598235|SUPERIORITY||||||<|0.0001||||||P-value of \<0.05 was considered statistically significant.|t-test, 2 sided|||||||<0.0001
74022747|NCT04551014|147598236|SUPERIORITY|||||||0.697||||||P-value of \<0.05 was considered statistically significant.|Chi-squared|||||||0.697
74022748|NCT01575912|147598350|OTHER|||||||0.121||||||using Mann Whitney test|Wilcoxon (Mann-Whitney)|||||||0.121
74084383|NCT02102932|147721993|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.29|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|101.92|108.78||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.78|101.92|0.0000
73846823|NCT02949011|147239795|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
73846824|NCT02949011|147239795|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
73846825|NCT02949011|147239795|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
74088246|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0009|TWO_SIDED|95.0|-0.96|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.25|-0.96|0.0009
73846826|NCT02949011|147239795|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||<0.0001
73846827|NCT02949011|147239795|SUPERIORITY|||||||0.0044||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0044
73846828|NCT02949011|147239795|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||<0.0001
74022749|NCT02091440|147598352|OTHER|Single group|Proportion|100.0|||||TWO_SIDED|95.0||||||||||||
74022750|NCT02091440|147598353|OTHER|Single group|Kaplan-Meier Survival|100.0|||||TWO_SIDED|||||||||||||
74022751|NCT02091440|147598354|OTHER|Single group|Incidence|1.24|||||TWO_SIDED|||||||||||||
74022752|NCT02091440|147598355|OTHER|Single group|Incidence|1.66|||||TWO_SIDED|||||||||||||
73846829|NCT02949011|147239795|SUPERIORITY|||||||0.1146||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.1146
73960057|NCT02027558|147455662|SUPERIORITY||Mean Difference (Final Values)|-17.42|STANDARD_ERROR_OF_MEAN|4.99||0.0007|TWO_SIDED|95.0|-27.29|-7.55|||t-test, 2 sided|||||-7.55|-27.29|0.0007
74022753|NCT02091440|147598356|OTHER|Single group|Change from baseline|19.4|STANDARD_DEVIATION|11.39|||TWO_SIDED|95.0|7.5|31.4|||||Confidence interval based on t-distribution.|||31.4|7.5|
74022754|NCT02091440|147598357|OTHER|Single group|Percentage change|-83.33|||||TWO_SIDED||||||||Percentage change from 24 months to screening in NYHA classes III and IV. Percentage change is 16.67% - 100% = -83.33%|||||
74022755|NCT02091440|147598358|OTHER|Single group|Change from baseline|130.0|STANDARD_DEVIATION|275.32|||TWO_SIDED|95.0|-158.9|418.9|||||Confidence interval based on t-distribution.|||418.9|-158.9|
74022756|NCT03576144|147598369|OTHER||Slope|1.0474|STANDARD_ERROR_OF_MEAN|0.0283|||TWO_SIDED|90.0|0.9997|1.0951|||ANCOVA||Standard Error of the mean is actually standard error of slope.Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for AUC0-12 of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.0951|0.9997|
74022757|NCT03576144|147598370|OTHER||Slope|1.0091|STANDARD_ERROR_OF_MEAN|0.038|||TWO_SIDED|90.0|0.9451|1.0732|||ANCOVA||Standard Error of the is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for Cmax of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.0732|0.9451|
74084384|NCT02102932|147721993|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.23|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|99.91|106.65||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.65|99.91|0.0000
73846830|NCT02949011|147239795|SUPERIORITY|||||||0.0046||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.0046
73846831|NCT02949011|147239795|SUPERIORITY|||||||0.441||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.441
73846832|NCT02949011|147239795|SUPERIORITY|||||||0.0929||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0929
73846833|NCT02949011|147239795|SUPERIORITY|||||||0.0907||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0907
73846834|NCT02949011|147239796|SUPERIORITY|||||||0.7383||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||0.7383
73846835|NCT02949011|147239796|SUPERIORITY|||||||0.9619||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||0.9619
73846836|NCT02949011|147239796|SUPERIORITY|||||||0.0576||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0576
73846837|NCT02949011|147239796|SUPERIORITY|||||||0.1237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.1237
73846838|NCT02949011|147239796|SUPERIORITY|||||||0.3071||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.3071
73846839|NCT02949011|147239796|SUPERIORITY|||||||0.9603||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.9603
73846840|NCT02949011|147239796|SUPERIORITY|||||||0.0784||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.0784
73846841|NCT02949011|147239796|SUPERIORITY|||||||0.5547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5547
73846842|NCT02949011|147239796|SUPERIORITY|||||||0.3087||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.3087
73846843|NCT02949011|147239796|SUPERIORITY|||||||0.9106||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9106
73846844|NCT02949011|147239796|SUPERIORITY|||||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0017
73846845|NCT02949011|147239796|SUPERIORITY|||||||0.3068||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.3068
73846846|NCT02949011|147239797|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
73846847|NCT02949011|147239797|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
73846848|NCT02949011|147239797|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
73846849|NCT02949011|147239797|SUPERIORITY|||||||0.0024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0024
73846850|NCT02949011|147239797|SUPERIORITY|||||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ven Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.9127
73846851|NCT02949011|147239797|SUPERIORITY|||||||0.5361||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.5361
73899211|NCT01087788|147329894|SUPERIORITY_OR_OTHER||Difference in Percentages|27.6|||<|0.001|TWO_SIDED|95.0|16.5|38.7||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||38.7|16.5|<0.001
73846852|NCT02949011|147239797|SUPERIORITY|||||||0.5739||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5739
73846853|NCT02949011|147239797|SUPERIORITY|||||||0.5466||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5466
73846854|NCT02949011|147239797|SUPERIORITY|||||||0.0543||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.0543
73846855|NCT02949011|147239797|SUPERIORITY|||||||0.4677||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.4677
73899212|NCT01087788|147329895|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-10.64|STANDARD_ERROR_OF_MEAN|8.35|=|0.203|TWO_SIDED|95.0|-27.05|5.77||Diff. of CZP 200mg+400mg versus PBO (and corresponding 95% Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior Tumor Necrosis Factor(TNF)-antagonist exposure as factors \& BL mTSS score as a covariate|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the pre-defined primary analysis.||5.77|-27.05|=0.203
73899213|NCT01087788|147329895|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.09|=|0.017|TWO_SIDED|95.0|-0.38|-0.04||Difference of CZP 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)||-0.04|-0.38|=0.017
73960058|NCT02694978|147455700|NON_INFERIORITY|The non-inferiority margin of 2.64% was used for the primary endpoint statistical analysis.|Treatment difference|-0.1||||0.0001|TWO_SIDED|95.0|-0.8|0.61|||Wald|The p-value was calculated using the Wald large sample assumption.||"Statistical analysis was only performed on composite reaction data (that is, the Any TE moderate to severe hypersensitivity rxn row in the data table)."||0.61|-0.80|0.0001
73846856|NCT02949011|147239797|SUPERIORITY|||||||0.0266||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0266
73846857|NCT02949011|147239797|SUPERIORITY|||||||0.1281||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.1281
73960059|NCT02138006|147455743|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Log Rank|||||||0.30
73970968|NCT05139810|147481976|SUPERIORITY||IC HAE attack rate ratio|0.11|||<|0.001|TWO_SIDED|95.0|0.035|0.339|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.339|0.035|<0.001
73846858|NCT02949011|147239798|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
73846859|NCT02949011|147239798|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
73846860|NCT02949011|147239798|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
73846861|NCT02949011|147239798|SUPERIORITY|||||||0.0015||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0015
73846862|NCT02949011|147239798|SUPERIORITY|||||||0.0028||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0028
73899214|NCT01087788|147329895|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|=|0.261|TWO_SIDED|95.0|-0.27|0.07||Difference of CZP 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)||0.07|-0.27|=0.261
73899215|NCT01087788|147329896|SUPERIORITY_OR_OTHER||Difference in Percentages|40.2|||<|0.001|TWO_SIDED|95.0|29.5|51.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||51.0|29.5|<0.001
73899216|NCT01087788|147329896|SUPERIORITY_OR_OTHER||Difference in Percentages|32.8|||<|0.001|TWO_SIDED|95.0|21.8|43.8||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||43.8|21.8|<0.001
73899217|NCT01087788|147329897|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.42|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline HAQ-DI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.20|-0.42|<0.001
73899218|NCT01087788|147329898|SUPERIORITY_OR_OTHER||Difference in Percentages|46.3|||<|0.001|TWO_SIDED|95.0|35.7|56.9||Difference of Certolizumab Pegol 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||56.9|35.7|<0.001
73899219|NCT01087788|147329899|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.12|=|0.127|TWO_SIDED|95.0|-0.43|0.05||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the predefined analysis.||0.05|-0.43|=0.127
73899220|NCT01087788|147329899|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.26|=|0.048|TWO_SIDED|95.0|-1.04|-0.01||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the post-hoc analysis for the subgroup 'Baseline mTSS \> 6'.||-0.01|-1.04|=0.048
73899221|NCT02589600|147329900|SUPERIORITY||Incident Rate Ratio|1.05||||0.7251|TWO_SIDED|95.0|0.9|1.22|||Negative binomial regression||Placebo group is the reference group||Negative binomial regression implemented in the SAS®️ GENMOD procedure with fracture outcome as the dependent variable; duration of follow-up as an offset to account for each participant's exposure; treatment arm as the main independent factor of interest.|1.22|.90|0.7251
73970969|NCT05139810|147481976|SUPERIORITY||IC HAE attack rate ratio|0.59|||=|0.173|TWO_SIDED|95.0|0.276|1.26|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||1.260|0.276|=0.173
73899222|NCT03044574|147329907|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73899223|NCT03044574|147329908|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
73899224|NCT03044574|147329909|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73899225|NCT03044574|147329910|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
73899226|NCT03044574|147329911|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
73899227|NCT03044574|147329912|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
73899228|NCT03044574|147329913|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73899229|NCT03044574|147329915|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
74084385|NCT02102932|147721993|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.56|STANDARD_DEVIATION|7.6||0|TWO_SIDED|90.0|99.73|107.54||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||107.54|99.73|0.0000
73846863|NCT02949011|147239798|SUPERIORITY|||||||0.0265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0265
73846864|NCT02949011|147239798|SUPERIORITY|||||||0.0247||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.0247
73846865|NCT02949011|147239798|SUPERIORITY|||||||0.5298||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5298
73846866|NCT02949011|147239798|SUPERIORITY|||||||0.9554||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9554
73846867|NCT02949011|147239798|SUPERIORITY|||||||0.9075||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9075
73846868|NCT02949011|147239798|SUPERIORITY|||||||0.7624||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.7624
73846869|NCT02949011|147239798|SUPERIORITY|||||||0.6156||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.6156
73846870|NCT02949011|147239799|SUPERIORITY|||||||0.034||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0340
73846871|NCT02949011|147239799|SUPERIORITY|||||||0.2766||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.2766
73846872|NCT02949011|147239800|SUPERIORITY|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0072
73846873|NCT02949011|147239800|SUPERIORITY|||||||0.733||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.7330
73846874|NCT02949011|147239801|SUPERIORITY||Median Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-48.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||-48.0|-48.0|<0.0001
73899230|NCT01816451|147329927|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For pre-post training variables data were expressed as mean and standard deviation. Heart Rate and Blood Lactate, were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables absolute and relative VO2, tVO2, Body Fat, Body Mass, RPE, were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used.||||< 0.05
73846875|NCT02949011|147239801|SUPERIORITY||Median Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||-24.0|-48.0|<0.0001
73846876|NCT02949011|147239802|SUPERIORITY||Median Difference|-24.0||||0.0006|TWO_SIDED|95.0|-96.0|0.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||0.0|-96.0|0.0006
73846877|NCT02949011|147239802|SUPERIORITY||Median Difference|0.0||||0.237|TWO_SIDED|95.0|-48.0|24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||24.0|-48.0|0.2370
73846878|NCT02949011|147239803|SUPERIORITY|||||||0.7698||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.7698
73846879|NCT02949011|147239803|SUPERIORITY|||||||0.5777||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.5777
73846880|NCT02949011|147239803|SUPERIORITY|||||||0.1112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.1112
74022758|NCT03576144|147598371|OTHER||Slope|1.052|STANDARD_ERROR_OF_MEAN|0.0325|||TWO_SIDED|90.0|0.9972|1.1069|||ANCOVA||Standard Error of the mean is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for AUCτ,ss of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.1069|0.9972|
74022759|NCT03576144|147598372|OTHER||Slope|1.0361|STANDARD_ERROR_OF_MEAN|0.0379|||TWO_SIDED|90.0|0.9722|1.1001|||ANCOVA||Standard Error of the mean is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for Cmax,ss of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.1001|0.9722|
74022760|NCT03263091|147598387|OTHER||Odds Ratio (OR)|1.582||||0.217|TWO_SIDED|95.0|0.761|3.29|||Cochran-Mantel-Haenszel|||The odds ratio along with its 95% confidence interval (CI) were calculated based on the Cochran-Mantel-Haenszel (CMH) chi-square test adjusting for the stratification factors (EPO level, International Prognostic Scoring System - Revised \[IPSS-R\] risk category and RBC transfusion burden).||3.290|0.761|0.217
74022761|NCT05067127|147598476|SUPERIORITY||Difference in least squares (LS) mean|-1.143|||<|0.0001|TWO_SIDED|95.0|-1.436|-0.85|||MMRM|||An mixed-effect model for repeated measures (MMRM) including fixed categorical effect for treatment group, visit, disease type, baseline immunosuppressants use, stratification factors, and the visit-by-treatment group interactions as well as the continuous, fixed covariate of baseline log-transformed uPCR, was utilized to analyze the log-transformed ratio of uPCR at Week 26 compared to baseline.||-0.85|-1.436|<0.0001
74022762|NCT05067127|147598477|SUPERIORITY||Odds Ratio (OR)|27.516|||<|0.0001|TWO_SIDED|95.0|6.105|124.026|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline eGFR values, baseline log-transformed uPCR values, disease type, and stratification factors.||124.026|6.105|<0.0001
74022763|NCT05067127|147598478|SUPERIORITY||Odds Ratio (OR)|30.932|||<|0.0001|TWO_SIDED|95.0|8.401|113.897|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline log-transformed uPCR values, disease type, and stratification factors.||113.897|8.401|<0.0001
74084386|NCT02102932|147721993|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.81|STANDARD_DEVIATION|6.9||0|TWO_SIDED|90.0|99.36|106.37||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.37|99.36|0.0000
73846881|NCT02949011|147239803|SUPERIORITY|||||||0.6483||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.6483
73846882|NCT02949011|147239803|SUPERIORITY|||||||0.0004||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.0004
73899231|NCT01816451|147329927|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post training data were expressed as mean and standard deviation. HR and \[La\], were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables RPE, Velocity were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used. Control didn't do submaximal test for training intensities.||||<0.05
74022764|NCT05067127|147598479|SUPERIORITY||Difference in LS mean|-1.002||||0.2753|TWO_SIDED|95.0|-2.803|0.798|||ANCOVA|||Analysis of covariance (ANCOVA) model included treatment as fixed effect, adjusted for baseline C3G histologic index activity score, disease type, and stratification factors.||0.798|-2.803|0.2753
74022765|NCT05067127|147598480|SUPERIORITY||Odds Ratio (OR)|27.392|||<|0.0001|TWO_SIDED|95.0|6.477|115.852|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline C3c staining, disease type, and stratification factors.||115.852|6.477|<0.0001
74022766|NCT05067127|147598481|SUPERIORITY||Difference in LS mean|6.312||||0.0333|TWO_SIDED|95.0|0.501|12.122|||MMRM|||An MMRM model included fixed categorical effect for treatment group, visit, disease type, stratification factors, and the visit-by-treatment group interactions as well as the continuous, fixed covariate of baseline eGFR, was utilized to analyze the mean change from baseline to Week 26 in eGFR.||12.122|0.501|0.0333
74084387|NCT02102932|147721994|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.56|STANDARD_DEVIATION|14.0||0.0001|TWO_SIDED|90.0|97.56|112.07||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.07|97.56|0.0001
73846883|NCT02949011|147239803|SUPERIORITY|||||||0.5625||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.5625
73899232|NCT00481507|147329989|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82|||>|0.05|TWO_SIDED|95.0|0.54|1.43||Reply: Only one test was performed for the primary outcome. No covariates were entered into this model and p-value is unadjusted.|Chi-squared|The results obtained from the logistic regression are equivalent to the chi-square test with one degree of freedom.||Reply: The null hypothesis was the rates of diarrhea for Kefir vs. Placebo are not different. Post power calculation was not performed because the difference observed (21.9% vs. 18%) was less than a difference that which would be considered clinically important.||1.43|0.54|>.05
74022767|NCT05067127|147598482|SUPERIORITY||Odds Ratio (OR)|5.753||||0.0006|TWO_SIDED|95.0|2.106|15.716|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline proteinuria values, disease type, and stratification factors.||15.716|2.106|0.0006
74022768|NCT05067127|147598483|SUPERIORITY||Odds Ratio (OR)|88.341||||0.0001|TWO_SIDED|95.0|8.863|880.544|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline albumin values, disease type, and stratification factors.||880.544|8.863|0.0001
74022769|NCT05067127|147598484|SUPERIORITY||Odds Ratio (OR)|999.999||||0.0094|TWO_SIDED|95.0|12.175|9999.999|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline C3 levels, stratification factors and disease type.||9999.999|12.175|0.0094
74022770|NCT05067127|147598485|SUPERIORITY||Difference in LS mean|0.562||||0.7384|TWO_SIDED|95.0|-2.739|3.863|||ANCOVA|||The ANCOVA model included treatment as fixed effect, adjusted for baseline, disease type, and stratification factors.||3.863|-2.739|0.7384
74022771|NCT05067127|147598486|SUPERIORITY||Difference in LS mean|1.345||||0.5648|TWO_SIDED|95.0|-3.237|5.927|||ANCOVA|||The ANCOVA model included treatment as fixed effect, adjusted for baseline, disease type, and stratification factors.||5.927|-3.237|0.5648
74022772|NCT01499173|147598492|SUPERIORITY||||||<|0.01||||||Actual p value shown here; not threshold.|multilevel linear regression|||||||<0.01
74022773|NCT01499173|147598493|SUPERIORITY|||||||0.34|||||||multilevel linear regression|||||||0.34
74022774|NCT01499173|147598494|OTHER|odds ratio|Odds Ratio (OR)|-0.5|||||TWO_SIDED|||||||||Odds ratio was calculated for each question comparing 1 week data with 1 month data||||
74022775|NCT02354833|147598503|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
74022776|NCT02354833|147598504|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||This analysis is comparing the percentage of participants with Nausea||||0.28
74022777|NCT02354833|147598504|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||This analysis is comparing the percentage of participants with Emesis||||< 0.001
74022778|NCT02354833|147598505|SUPERIORITY_OR_OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.10
74022779|NCT02354833|147598506|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
73899233|NCT03381729|147330012|SUPERIORITY||Difference in Percent|-6.0|||>|0.9999|TWO_SIDED|95.0|-21.8|22.8|||Fisher Exact|||Difference in the percentage of participants who achieved the ability to stand alone.|Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 7 (13.7%) participants achieved the ability to stand alone and 44 (86.3%) participants did not achieve the ability to stand alone.|22.8|-21.8|>0.9999
74022780|NCT02148029|147598518|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.34|TWO_SIDED|95.0|-1.1|3.1|||t-test, 2 sided||Mean difference = Exercise - Control|||3.1|-1.1|0.34
74022781|NCT02148029|147598519|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|3.5||0.89|TWO_SIDED|95.0|-7.1|8.0|||t-test, 2 sided||Mean difference = Exercise - Control|||8.0|-7.1|0.89
74022782|NCT02148029|147598520|SUPERIORITY||Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|7.2||0.43|TWO_SIDED|95.0|-20.3|8.4|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Physical Functioning (PF) domain score.||8.4|-20.3|0.43
74022783|NCT02148029|147598520|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.3||0.13|TWO_SIDED|95.0|-1.6|11.6|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to Physical health problems (RP) domain score.||11.6|-1.6|0.13
74022784|NCT02148029|147598520|SUPERIORITY||Mean Difference (Net)|2.7|STANDARD_ERROR_OF_MEAN|2.8||0.33|TWO_SIDED|95.0|-2.8|8.2|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to mental health or Emotional problems (RE) domain score.||8.2|-2.8|0.33
74022785|NCT02148029|147598520|SUPERIORITY||Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|7.1||0.43|TWO_SIDED|95.0|-8.7|20.0|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the energy/fatigue/Vitality (VT) domain score.||20.0|-8.7|0.43
74022786|NCT02148029|147598520|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|5.6||0.64|TWO_SIDED|95.0|-13.8|8.6|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Mental Health/emotional well-being (MH) domain score.||8.6|-13.8|0.64
74022787|NCT02148029|147598520|SUPERIORITY||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|8.3||0.64|TWO_SIDED|95.0|-20.5|12.8|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Social Functioning (SF) domain score.||12.8|-20.5|0.64
74022788|NCT02148029|147598520|SUPERIORITY||Mean Difference (Net)|9.5|STANDARD_ERROR_OF_MEAN|10.1||0.35|TWO_SIDED|95.0|-10.7|29.7|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Bodily Pain (BP) domain score.||29.7|-10.7|0.35
74022789|NCT02148029|147598520|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|5.3||0.5|TWO_SIDED|95.0|-14.1|7.0|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the General Health (GH) domain score.||7.0|-14.1|0.50
74022790|NCT02148029|147598521|SUPERIORITY||Mean Difference (Net)|-33.9|STANDARD_ERROR_OF_MEAN|30.1||0.27|TWO_SIDED|95.0|-95.5|27.7|||t-test, 2 sided||Mean difference = Exercise - Control|||27.7|-95.5|0.27
74022791|NCT02148029|147598522|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.07|TWO_SIDED|95.0|-3.4|0.1|||t-test, 2 sided||Mean difference = Reflux - No reflux|||0.1|-3.4|0.07
74022792|NCT02148029|147598523|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.4||0.91|TWO_SIDED|95.0|-0.8|0.9|||t-test, 2 sided||Mean difference = PTS - No PTS|||0.9|-0.8|0.91
74022793|NCT01157117|147598561|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.0||||0.42|TWO_SIDED|95.0|-13.4|37.3||No adjustments were made to the p-value.|Fisher Exact|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of milk protein followed by an open feeding of milk was compared using Fisher's Exact test with the null hypothesis that there was no difference between treatment groups.||37.3|-13.4|0.42
74022794|NCT00826514|147598575|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|95.0|-1.15|0.209||||||Analysis was based on analysis of co-variance (ANCOVA) model with baseline value, age and treatment as covariates.||0.209|-1.150|
73846884|NCT02949011|147239803|SUPERIORITY|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.0072
73846885|NCT02949011|147239803|SUPERIORITY|||||||0.6234||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.6234
73846886|NCT02949011|147239803|SUPERIORITY|||||||0.0002||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.0002
73846887|NCT02949011|147239803|SUPERIORITY|||||||0.9547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.9547
73846888|NCT02949011|147239803|SUPERIORITY|||||||0.0012||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.0012
73846889|NCT02949011|147239803|SUPERIORITY|||||||0.186||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.1860
73846890|NCT02949011|147239803|SUPERIORITY|||||||0.0274||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.0274
73846891|NCT02949011|147239803|SUPERIORITY|||||||0.9635||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.9635
73846892|NCT02949011|147239803|SUPERIORITY|||||||0.0081||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.0081
73846893|NCT02949011|147239803|SUPERIORITY|||||||0.7425||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.7425
73846894|NCT02949011|147239803|SUPERIORITY|||||||0.0209||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.0209
73846895|NCT02949011|147239803|SUPERIORITY|||||||0.7448||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.7448
73846896|NCT02949011|147239803|SUPERIORITY|||||||0.0644||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.0644
73846897|NCT02949011|147239803|SUPERIORITY|||||||0.4931||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.4931
73846898|NCT02949011|147239803|SUPERIORITY|||||||0.0708||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.0708
73846899|NCT02949011|147239803|SUPERIORITY|||||||0.4024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.4024
73846900|NCT02949011|147239804|SUPERIORITY||Median Difference|-25.8|||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||<0.0001
73846901|NCT02949011|147239804|SUPERIORITY||Median Difference|-8.6||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.9127
73846902|NCT02949011|147239805|SUPERIORITY||Median Difference|-15.1||||0.0013||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0013
73846903|NCT02949011|147239805|SUPERIORITY||Median Difference|2.3||||0.8498||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.8498
73846904|NCT02949011|147239806|SUPERIORITY||Median Difference|-24.1||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0001
73846905|NCT02949011|147239806|SUPERIORITY||Median Difference|1.5||||0.9237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.9237
73899234|NCT03381729|147330013|SUPERIORITY||Difference Between Least Squares Mean|5.5||||0.0027|TWO_SIDED|95.0|1.9|9.0|||Mixed-Model Repeat Measure||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where the least squares mean (95% confidence interval) of the change from baseline in HFMSE scores at 12 months was 0.5 (-2.2 to 3.2).|9.0|1.9|0.0027
73899235|NCT03381729|147330015|SUPERIORITY||Percentage Difference|-2.1|||>|0.9999|TWO_SIDED|95.0|-17.2|27.0|||Fisher Exact|||Difference in the percentage of participants who achieved the ability to walk alone.|Data for the current study were compared to historical control data (Finkel et al 2014 PubMed 25080519) where 5 (9.8%) participants achieved the ability to walk alone and 46 (90.2%) participants did not achieve the ability to walk alone.|27.0|-17.2|>0.9999
73899236|NCT03445156|147330029|OTHER|ANCOVA||||||0.04|||||||ANCOVA|F(2, 273) = 3.16, p = .044, partial c\^2 = .023||||||0.04
73899237|NCT03445156|147330029|OTHER|ANCOVA||||||0.0001|||||||ANCOVA|F(1, 36) = 44.42||||||.0001
73899238|NCT03445156|147330030|OTHER|ANCOVA|||||<|0.001|||||||ANCOVA|F(1, 36) = 44.42||Hypothesis: Participants who played a violent FPS game were expected to have more hits to targets with heads or faces than were participants who played a nonviolent shooting game.||||<.001
73899239|NCT03445156|147330030|OTHER|ANCOVA||||||0.044|||||||ANCOVA|F(2, 273) = 3.16||Hypothesis: Participants who played a violent FPS game were expected to hit the mannequin's head more often than were participants who played either the nonviolent shooting game or the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.||||.044
73899240|NCT03445156|147330030|OTHER|ANCOVA||||||0.17|||||||t-test, 2 sided|t(274) = 2.40||"Hypothesis: Because the nonviolent shooting game rewards other shots, participants who played a nonviolent shooting game were expected to hit the mannequin's torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."||||0.17
73899241|NCT03445156|147330030|OTHER|ANCOVA||||||0.449|||||||t-test, 2 sided|t(274) = -0.76||Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin's head less often than were participants who played the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.||||.449
73899242|NCT03445156|147330030|OTHER|ANCOVA||||||0.645|||||||t-test, 2 sided|t(273) = -0.46||"Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin's torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."||||.645
73899243|NCT03445156|147330030|OTHER|Zero-order correlation||||||0.032|||||||Zero-order correlation|||Hypothesis: A positive correlation was expected between the number of violent shooting games participants listed among their three favorite video games and hits to the mannequin's head.||||.032
73899244|NCT04456153|147330031|SUPERIORITY|||||||0.17|||||||GLMM|||||||0.170
73899245|NCT04456153|147330032|SUPERIORITY|||||||0.051|||||||GLMM|||||||0.051
73899246|NCT04456153|147330035|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
73899247|NCT04456153|147330036|SUPERIORITY|||||||0.76|||||||trapezoidal method|||||||0.76
73899248|NCT03758755|147330038|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.0219|||||||t-test, 1 sided|||Null hypothesis: there is no difference between groups in IKDC score at 12 weeks post-op.||||0.0219
73899249|NCT03758755|147330039|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.008|||||||t-test, 1 sided|||Null hypothesis: there is no difference between groups in VAS score at 12 weeks post-op.||||0.008
73899250|NCT03758755|147330040|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.011|||||||t-test, 1 sided|||This analysis compares the change over time in quadriceps tendon strength between the BFR Therapy group and the No BFR Group. Underlying data was collected on a biweekly basis as the percent difference of the operated knee compared to the contralateral side. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in quadriceps tendon strength over time.||||0.011
73899251|NCT03758755|147330041|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.223|||||||t-test, 1 sided|||This analysis compares the change over time in thigh circumference between the BFR Therapy group and the No BFR Group. Underlying data was collected on a biweekly basis as the percent difference of the operated knee compared to the contralateral side. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in thigh circumference over time.||||0.223
73899252|NCT03758755|147330042|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.242|||||||t-test, 1 sided|||This analysis compares the change over time in degrees of knee flexion between the BFR Therapy group and the No BFR Group from 2 weeks post-op to 12 weeks post-op. Underlying data was collected on a biweekly basis. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in degrees of knee flexion over time.||||0.242
73899253|NCT03758755|147330043|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.049|||||||t-test, 1 sided|||This analysis compares the change over time in degrees of knee extension between the BFR Therapy group and the No BFR Group from 2 weeks post-op to 12 weeks post-op. Underlying data was collected on a biweekly basis. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in degrees of knee extension over time.||||0.049
73899254|NCT00906971|147330084|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of defecations was recorded.|||||<|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.||||||<0.05
73899255|NCT00906971|147330085|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of fecal incontinence was recorded reported at the beginning of the study|||||>|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.||||||>0.05
74022795|NCT00826514|147598578|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.42|STANDARD_ERROR_OF_MEAN|1.901|||TWO_SIDED|90.0|-4.754|1.905||||||Change at Week 6, CPSI Total Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.905|-4.754|
74022796|NCT00826514|147598578|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.931|||TWO_SIDED|90.0|-2.701|0.591||||||Change at Week 6, CPSI PD Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.591|-2.701|
74022797|NCT00826514|147598578|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|90.0|-0.789|1.541||||||Change at Week 6, CPSI US Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.541|-0.789|
74022798|NCT00826514|147598578|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.697|||TWO_SIDED|90.0|-1.785|0.631||||||Change at Week 6, CPSI QoL Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.631|-1.785|
74022799|NCT00826514|147598579|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.649|||TWO_SIDED|90.0|-0.99|1.348||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.348|-0.990|
74022800|NCT00826514|147598580|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|90.0|-1.829|1.452||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.452|-1.829|
74022801|NCT00826514|147598581|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-33.56|STANDARD_ERROR_OF_MEAN|17.026|||TWO_SIDED|90.0|-64.144|-2.968||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||-2.968|-64.144|
74022802|NCT00826514|147598582|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-1.364|0.415||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.415|-1.364|
74022803|NCT00826514|147598583|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-3.146|0.401||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.401|-3.146|
74022804|NCT00826514|147598584|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|90.0|-0.417|0.334||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.334|-0.417|
74022805|NCT00826514|147598585|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.765|||TWO_SIDED|90.0|-1.791|1.822||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.822|-1.791|
74022806|NCT00826514|147598586|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.833|||||TWO_SIDED|90.0|0.763|4.407||||||Week 6: Logistic regression model with age, baseline pain stratification group and treatment as covariates.||4.407|0.763|
74022807|NCT00826514|147598586|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|||||TWO_SIDED|90.0|0.388|2.575||||||Week 16: Logistic regression model with age, baseline pain stratification group and treatment as covariates.||2.575|0.388|
74022808|NCT01834404|147598652|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||ANCOVA|||||||0.057
74022809|NCT01834404|147598653|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||ANCOVA|||||||0.052
74022810|NCT01834404|147598654|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||ANCOVA|||||||0.36
74022811|NCT01834404|147598655|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||ANCOVA|||||||0.99
74022812|NCT01834404|147598656|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANCOVA|||||||0.45
74022813|NCT01834404|147598657|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANCOVA|||||||0.22
74022814|NCT01834404|147598658|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||||||0.032
74022815|NCT01834404|147598659|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANCOVA|||This p-value was based on a rank transformation.||||0.030
74022816|NCT01834404|147598660|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||ANCOVA|||||||0.35
74022817|NCT01834404|147598661|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANCOVA|||||||0.72
74022818|NCT01834404|147598662|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANCOVA|||||||0.90
74022819|NCT01834404|147598663|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.54
74022820|NCT01834404|147598664|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.26
74022821|NCT01360996|147598665|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
74022822|NCT01360996|147598666|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74022823|NCT01360996|147598667|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74022824|NCT01360996|147598668|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
74022825|NCT01360996|147598669|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||McNemar|||||||<0.0001
74022826|NCT01360996|147598670|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
74022827|NCT01360996|147598671|SUPERIORITY_OR_OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
74022828|NCT02537678|147598672|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.43||0.006|ONE_SIDED|97.5|-3.26||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.|Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT||-3.26|.006
74088247|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0377|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.02|-0.78|0.0377
73899256|NCT00545129|147330086|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.45||0.569|TWO_SIDED|95.0|-1.18|0.66|||ANCOVA|||Analysis of covariance (ANCOVA) model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. Least squares (LS) mean difference, and corresponding 95% confidence interval (CI) were estimated from ANCOVA model.||0.66|-1.18|0.569
73899257|NCT00545129|147330087|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.23||0.581|TWO_SIDED|95.0|-0.6|0.34|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.34|-0.60|0.581
73899258|NCT00545129|147330087|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.32||0.795|TWO_SIDED|95.0|-0.56|0.73|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.73|-0.56|0.795
73899259|NCT00545129|147330087|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.41||0.843|TWO_SIDED|95.0|-0.76|0.93|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.93|-0.76|0.843
73899260|NCT00545129|147330087|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.43||0.292|TWO_SIDED|95.0|-1.34|0.42|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.42|-1.34|0.292
73899261|NCT00545129|147330088|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.23||0.299|TWO_SIDED|95.0|-0.72|0.23|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.23|-0.72|0.299
73899262|NCT00545129|147330088|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.34||0.519|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.47|0.519
73899263|NCT00545129|147330088|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.42||0.776|TWO_SIDED|95.0|-0.74|0.98|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.98|-0.74|0.776
73899264|NCT00545129|147330088|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.45||0.978|TWO_SIDED|95.0|-0.93|0.91|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.93|0.978
73899265|NCT00545129|147330088|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.45||0.689|TWO_SIDED|95.0|-1.1|0.73|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.73|-1.10|0.689
73899266|NCT00545129|147330089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.23||0.299|TWO_SIDED|95.0|-0.72|0.23|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.23|-0.72|0.299
73899267|NCT00545129|147330089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.34||0.519|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.47|0.519
74022829|NCT02537678|147598673|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|1.49||0.004|ONE_SIDED|97.5|-3.47||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.|Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT||-3.47|.004
73899268|NCT00545129|147330089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.44||0.618|TWO_SIDED|95.0|-0.68|1.13|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.13|-0.68|0.618
73899269|NCT00545129|147330089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.47||0.818|TWO_SIDED|95.0|-0.85|1.07|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.07|-0.85|0.818
73899270|NCT00545129|147330089|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.48||0.819|TWO_SIDED|95.0|-0.87|1.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.09|-0.87|0.819
73899271|NCT00545129|147330090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.34||0.906|TWO_SIDED|95.0|-0.66|0.74|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.74|-0.66|0.906
73899272|NCT00545129|147330090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.44||0.906|TWO_SIDED|95.0|-0.95|0.85|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.85|-0.95|0.906
73899273|NCT00545129|147330090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.5||0.613|TWO_SIDED|95.0|-0.78|1.29|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.29|-0.78|0.613
74022830|NCT02537678|147598674|NON_INFERIORITY|We planned 0.41standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied 12-month assessment.|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.2||0.001|ONE_SIDED|97.5|-2.5||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.50|.001
74022831|NCT02537678|147598675|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|ONE_SIDED|97.5|-2.94||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.94|<0.001
74088248|NCT02709486|147729988|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.0019|TWO_SIDED|95.0|-0.96|-0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.96|0.0019
73899274|NCT00545129|147330090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.46||0.988|TWO_SIDED|95.0|-0.95|0.94|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.94|-0.95|0.988
73899275|NCT00545129|147330090|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.47||0.922|TWO_SIDED|95.0|-1.01|0.92|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.92|-1.01|0.922
73899276|NCT00545129|147330091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.4||0.655|TWO_SIDED|95.0|-1.03|0.66|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.66|-1.03|0.655
73899277|NCT00545129|147330091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.44||0.897|TWO_SIDED|95.0|-0.85|0.96|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.96|-0.85|0.897
73899278|NCT00545129|147330091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.51||0.798|TWO_SIDED|95.0|-0.93|1.2|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.20|-0.93|0.798
73899279|NCT00545129|147330091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.51||0.672|TWO_SIDED|95.0|-0.83|1.27|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.27|-0.83|0.672
73899280|NCT00545129|147330091|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.48||0.243|TWO_SIDED|95.0|-1.56|0.41|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.41|-1.56|0.243
73899281|NCT00545129|147330092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.41||0.445|TWO_SIDED|95.0|-1.16|0.52|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.52|-1.16|0.445
73899282|NCT00545129|147330092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.49||0.992|TWO_SIDED|95.0|-1.0|1.0|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.00|-1.00|0.992
73899283|NCT00545129|147330092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.53||0.655|TWO_SIDED|95.0|-1.34|0.86|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.86|-1.34|0.655
73899284|NCT00545129|147330092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.86|TWO_SIDED|95.0|-1.09|1.3|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.30|-1.09|0.860
73846906|NCT02949011|147239807|SUPERIORITY||Median Difference|-19.8|||<|0.0001|TWO_SIDED|95.0|-28.8|-12.5||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||-12.5|-28.8|<0.0001
73960060|NCT01087762|147455745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3|||=|0.004|TWO_SIDED|95.0|6.3|32.4||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||32.4|6.3|=0.004
73960061|NCT01087762|147455745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.2|||<|0.001|TWO_SIDED|95.0|12.3|38.2||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||38.2|12.3|<0.001
73960062|NCT01087762|147455746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.7|||<|0.001|TWO_SIDED|95.0|25.4|50.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||50.0|25.4|<0.001
73960063|NCT01087762|147455746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.1|||<|0.001|TWO_SIDED|95.0|28.9|53.3||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||53.3|28.9|<0.001
73960064|NCT01087762|147455747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.96|-1.01||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.01|-1.96|<0.001
73960065|NCT01087762|147455748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.38|-1.38||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.38|-2.38|<0.001
73846907|NCT02949011|147239807|SUPERIORITY||Median Difference|-3.5||||0.2425|TWO_SIDED|95.0|-9.1|2.7||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||2.7|-9.1|0.2425
73846908|NCT02949011|147239808|SUPERIORITY|||||||0.1713||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.1713
73846909|NCT02949011|147239808|SUPERIORITY|||||||0.2249||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.2249
73846910|NCT02949011|147239808|SUPERIORITY|||||||0.0387||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.0387
73846911|NCT02949011|147239808|SUPERIORITY|||||||0.3915||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.3915
73846912|NCT02949011|147239808|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||<0.0001
73846913|NCT02949011|147239808|SUPERIORITY|||||||0.2617||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.2617
73846914|NCT02949011|147239808|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||<0.0001
73846915|NCT02949011|147239808|SUPERIORITY|||||||0.8808||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.8808
73846916|NCT02949011|147239808|SUPERIORITY|||||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.0001
73899285|NCT00545129|147330092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.59||0.595|TWO_SIDED|95.0|-1.52|0.89|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.89|-1.52|0.595
74088249|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.39|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-0.99|<.0001
73899286|NCT00545129|147330093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.179|TWO_SIDED|95.0|-1.76|0.35|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.35|-1.76|0.179
73899287|NCT00545129|147330093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.938|TWO_SIDED|95.0|-1.02|1.1|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.10|-1.02|0.938
73899288|NCT00545129|147330093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.55||0.621|TWO_SIDED|95.0|-1.41|0.86|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.86|-1.41|0.621
73899289|NCT00545129|147330093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.64||0.863|TWO_SIDED|95.0|-1.44|1.21|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.21|-1.44|0.863
73899290|NCT00545129|147330093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.59||0.237|TWO_SIDED|95.0|-1.95|0.51|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.51|-1.95|0.237
73899291|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||1|TWO_SIDED|95.0|0.1|4.94|||Fisher Exact|||Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.94|0.10|1.000
73899292|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||1|TWO_SIDED|95.0|0.23|3.32|||Fisher Exact|||Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.32|0.23|1.000
73899293|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||1|TWO_SIDED|95.0|0.05|6.35|||Fisher Exact|||Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.35|0.05|1.000
73899294|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.601|TWO_SIDED|95.0|0.44|4.53|||Fisher Exact|||Week 4 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.53|0.44|0.601
73846917|NCT02949011|147239808|SUPERIORITY|||||||0.5923||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.5923
73846918|NCT02949011|147239808|SUPERIORITY|||||||0.0064||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.0064
73846919|NCT02949011|147239808|SUPERIORITY|||||||0.6746||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.6746
73899295|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.36|TWO_SIDED|95.0|0.46|8.51|||Fisher Exact|||Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.51|0.46|0.360
73899296|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||1|TWO_SIDED|95.0|0.01|10.24|||Fisher Exact|||Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||10.24|0.01|1.000
73899297|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.596|TWO_SIDED|95.0|0.43|4.66|||Fisher Exact|||Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.66|0.43|0.596
73899298|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.552|TWO_SIDED|95.0|0.39|6.24|||Fisher Exact|||Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.24|0.39|0.552
73899299|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.612|TWO_SIDED|95.0|0.1|131.03|||Fisher Exact|||Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||131.03|0.10|0.612
73846920|NCT02949011|147239808|SUPERIORITY|||||||0.8167||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.8167
73846921|NCT02949011|147239808|SUPERIORITY|||||||0.3773||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.3773
73899300|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|19.66|||Fisher Exact|||Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||19.66|0.00|1.000
73846922|NCT02949011|147239808|SUPERIORITY|||||||0.1041||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.1041
73846923|NCT02949011|147239808|SUPERIORITY|||||||0.3328||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.3328
73846924|NCT02949011|147239808|SUPERIORITY|||||||0.7867||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.7867
73846925|NCT02949011|147239808|SUPERIORITY|||||||0.864||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.8640
73846926|NCT02949011|147239808|SUPERIORITY|||||||0.6465||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.6465
73846927|NCT02949011|147239808|SUPERIORITY|||||||0.4265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.4265
73846928|NCT02949011|147239808|SUPERIORITY|||||||0.6568||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.6568
73846929|NCT02949011|147239808|SUPERIORITY|||||||0.6102||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.6102
73846930|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.0408|TWO_SIDED|95.0|-0.28|-0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours||-0.01|-0.28|0.0408
73899301|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.73||||0.029|TWO_SIDED|95.0|1.04|14.32|||Fisher Exact|||Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||14.32|1.04|0.029
73846931|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5324|TWO_SIDED|95.0|-0.18|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours||0.09|-0.18|0.5324
73846932|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.06||0.0025|TWO_SIDED|95.0|-0.3|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours||-0.06|-0.30|0.0025
73846933|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.4874|TWO_SIDED|95.0|-0.08|0.16||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours||0.16|-0.08|0.4874
73846934|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.47|-0.24||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours||-0.24|-0.47|<0.0001
73846935|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.5414|TWO_SIDED|95.0|-0.15|0.08||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours||0.08|-0.15|0.5414
73899302|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.63||||0.143|TWO_SIDED|95.0|0.67|11.36|||Fisher Exact|||Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||11.36|0.67|0.143
73899303|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.07|15.25|||Fisher Exact|||Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||15.25|0.07|1.000
73899304|NCT00545129|147330094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.492|TWO_SIDED|95.0|0.0|3.57|||Fisher Exact|||Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.57|0.00|0.492
74022832|NCT02537678|147598676|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|2.25||0.044|ONE_SIDED|97.5|-6.33||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-6.33|.044
74022833|NCT02537678|147598677|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.75||0.002|ONE_SIDED|97.5|-3.07||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.07|0.002
74022834|NCT02537678|147598678|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|1.52||0.016|ONE_SIDED|97.5|-4.06||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.06|0.016
74022835|NCT02537678|147598679|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.77||0.003|ONE_SIDED|97.5|-3.72||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.72|0.003
74022836|NCT02537678|147598680|NON_INFERIORITY|We planned 0.41 standard deviation the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|1.89||0.007|ONE_SIDED|97.5|-3.89||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.89|0.007
74022837|NCT02537678|147598681|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.64||0.008|ONE_SIDED|97.5|-4.24||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.24|0.008
74022838|NCT02537678|147598682|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|1.78||0.015|ONE_SIDED|97.5|-4.88||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.88|0.015
74022839|NCT02537678|147598683|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|1.99||0.024|ONE_SIDED|97.5|-5.68||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.68|0.024
73846936|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.44|-0.22||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours||-0.22|-0.44|<0.0001
74088250|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.15||0.0002|TWO_SIDED|95.0|-0.87|-0.27|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.87|0.0002
73846937|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3185|TWO_SIDED|95.0|-0.17|0.05||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours||0.05|-0.17|0.3185
73846938|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.0025|TWO_SIDED|95.0|-0.26|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours||-0.06|-0.26|0.0025
73846939|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8299|TWO_SIDED|95.0|-0.09|0.11||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours||0.11|-0.09|0.8299
74022840|NCT02537678|147598684|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.001|ONE_SIDED|97.5|-0.39||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.39|0.001
74022841|NCT02537678|147598685|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.22||0.003|ONE_SIDED|97.5|-0.47||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.47|0.003
74022842|NCT02537678|147598686|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|ONE_SIDED|97.5|-0.3||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.30|<0.001
74022843|NCT02537678|147598687|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.001|ONE_SIDED|97.5|-0.29||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.29|0.001
74022844|NCT02537678|147598688|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.004|ONE_SIDED|97.5|-0.38||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.38|0.004
74022845|NCT02537678|147598689|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|ONE_SIDED|97.5|-0.19||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.19|<0.001
74022846|NCT02537678|147598690|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.47||0.005|ONE_SIDED|97.5|-3.33||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.33|0.005
74022847|NCT02537678|147598691|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|1.78||0.028|ONE_SIDED|97.5|-4.99||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.99|0.028
74022848|NCT02537678|147598692|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|1.62||0.009|ONE_SIDED|97.5|-3.64||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.64|0.009
74022849|NCT02537678|147598693|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.9||0.006|ONE_SIDED|97.5|-2.82||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.82|0.006
74022850|NCT02537678|147598694|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.88||0.001|ONE_SIDED|97.5|-2.31||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.31|0.001
74022851|NCT02537678|147598695|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Median Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|ONE_SIDED|97.5|-1.43||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-1.43|<0.001
73899305|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||1|TWO_SIDED|95.0|0.1|4.94|||Fisher Exact|||Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.94|0.10|1.000
73899306|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||1|TWO_SIDED|95.0|0.23|3.32|||Fisher Exact|||Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.32|0.23|1.000
74022852|NCT02537678|147598696|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|ONE_SIDED|97.5|-5.04||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.04|<0.001
74022853|NCT02537678|147598697|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.27||0.003|ONE_SIDED|97.5|-6.87||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-6.87|0.003
74084388|NCT02102932|147721994|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.8|STANDARD_DEVIATION|12.8||0.0001|TWO_SIDED|90.0|99.32|112.7||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.70|99.32|0.0001
73899307|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||1|TWO_SIDED|95.0|0.05|6.35|||Fisher Exact|||Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.35|0.05|1.000
73899308|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.795|TWO_SIDED|95.0|0.38|3.88|||Fisher Exact|||Week 4 (\>=30%) reduction: odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.88|0.38|0.795
74022854|NCT02537678|147598698|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults.Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|2.06|<|0.001|ONE_SIDED|97.5|-5.8||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.80|<0.001
74022855|NCT05003115|147598738|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-6.36||||0.101|TWO_SIDED|95.0|-14.17|1.44|||Regression, Linear|||||1.44|-14.17|0.101
74022856|NCT05003115|147598739|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.1||||0.78|TWO_SIDED|95.0|-0.79|0.59|||Regression, Linear|||||0.59|-0.79|0.78
74022857|NCT05003115|147598740|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.95||||0.314|TWO_SIDED|95.0|-2.83|0.94|||Regression, Linear|||||0.94|-2.83|0.314
74022858|NCT05003115|147598741|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-1.04||||0.679|TWO_SIDED|95.0|-6.0|3.92|||Regression, Linear|||||3.92|-6.00|0.679
74022859|NCT05003115|147598742|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|0.01||||0.994|TWO_SIDED|95.0|-2.23|2.25|||Regression, Linear|||||2.25|-2.23|0.994
74022860|NCT05003115|147598743|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-1.22||||0.258|TWO_SIDED|95.0|-3.33|0.89|||Regression, Linear|||||0.89|-3.33|0.258
74022861|NCT05003115|147598744|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.4||||0.857|TWO_SIDED|95.0|-4.75|3.96|||Regression, Linear|||||3.96|-4.75|0.857
74022862|NCT01147809|147598751|SUPERIORITY_OR_OTHER||Percent difference|21.1||||0.103|TWO_SIDED|95.0|-3.9|52.5|||ANCOVA|||||52.5|-3.9|0.103
74022863|NCT01147809|147598773|SUPERIORITY_OR_OTHER||Percent difference|12.9||||0.407|TWO_SIDED|95.0|-15.6|51.1|||ANCOVA|||||51.1|-15.6|0.407
74022864|NCT01147809|147598774|SUPERIORITY_OR_OTHER||Percent difference|-4.4||||0.802|TWO_SIDED|95.0|-33.5|37.4|||ANCOVA|||||37.4|-33.5|0.802
74022865|NCT01499290|147598782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-3.5|||||TWO_SIDED|95.0|-8.64|1.58||||||The primary objective of this study (FDA agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the mMITT in adult subjects with cIAI.||1.58|-8.64|
74022866|NCT01499290|147598783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-6.9|2.1||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the MITT in adult subjects with cIAI.||2.10|-6.90|
74022867|NCT01499290|147598784|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-0.8|||||TWO_SIDED|95.0|-4.61|2.89||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the CE in adult subjects with cIAI.||2.89|-4.61|
74022868|NCT00190775|147598807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|STANDARD_ERROR_OF_MEAN|1.11|<|0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.||||<0.001
74022869|NCT00190775|147598808|SUPERIORITY_OR_OTHER|||||||0.905||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.905
74022870|NCT00190775|147598808|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.491
74022871|NCT00190775|147598808|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.600
74022872|NCT00190775|147598808|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.052
74022873|NCT00190775|147598808|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.514
74022874|NCT00190775|147598808|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.515
74022875|NCT00190775|147598808|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.315
74022876|NCT00190775|147598809|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.176
74022877|NCT00190775|147598809|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.122
74022878|NCT00190775|147598809|SUPERIORITY_OR_OTHER|||||||0.931||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.931
74022879|NCT00190775|147598809|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
74022880|NCT00190775|147598809|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.190
74022881|NCT00190775|147598809|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.360
74022882|NCT00190775|147598809|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
74022883|NCT00190775|147598810|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.575
74022884|NCT00190775|147598810|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.705
74022885|NCT00190775|147598810|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.686
74022886|NCT00190775|147598810|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.618
74022887|NCT00190775|147598810|SUPERIORITY_OR_OTHER|||||||0.903||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.903
73899309|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.36|TWO_SIDED|95.0|0.46|8.51|||Fisher Exact|||Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.51|0.46|0.360
74022888|NCT00190775|147598810|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.807
73899310|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||1|TWO_SIDED|95.0|0.01|10.24|||Fisher Exact|||Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||10.24|0.01|1.000
73899311|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||1|TWO_SIDED|95.0|0.33|3.39|||Fisher Exact|||Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.39|0.33|1.000
74022889|NCT00190775|147598810|SUPERIORITY_OR_OTHER|||||||0.403||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.403
74022890|NCT00190775|147598811|SUPERIORITY_OR_OTHER|||||||0.941||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.941
74022891|NCT00190775|147598811|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
74022892|NCT00190775|147598811|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.391
74022893|NCT00190775|147598811|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.685
73960066|NCT01087762|147455749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.12||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.12|-2.07|<0.001
74022894|NCT00190775|147598811|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.774
74022895|NCT00190775|147598811|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.360
74022896|NCT00190775|147598811|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
74022897|NCT00190775|147598812|SUPERIORITY_OR_OTHER|||||||0.617||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.617
74022898|NCT00190775|147598812|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.789
74022899|NCT00190775|147598812|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.670
74022900|NCT00190775|147598812|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.018
74022901|NCT00190775|147598812|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.405
73899312|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.771|TWO_SIDED|95.0|0.33|4.83|||Fisher Exact|||Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.83|0.33|0.771
74022902|NCT00190775|147598813|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.544
74022903|NCT00190775|147598813|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.494
74022904|NCT00190775|147598813|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.547
74022905|NCT00190775|147598813|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.059
74022906|NCT00190775|147598813|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.918
74022907|NCT00190775|147598814|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.334
74022908|NCT00190775|147598814|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.087
73970970|NCT05139810|147481977|SUPERIORITY||Odds Ratio (OR)|310.35|||<|0.001|TWO_SIDED|95.0|11.63|8279.94|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 50% Reduction||8279.94|11.63|<0.001
74022909|NCT00190775|147598814|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.795
74022910|NCT00190775|147598814|SUPERIORITY_OR_OTHER|||||||0.955||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.955
74022911|NCT00190775|147598814|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
74022912|NCT00190775|147598815|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.248
74022913|NCT00190775|147598815|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.163
74022914|NCT00190775|147598815|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.947
74022915|NCT00190775|147598815|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.214
74022916|NCT00190775|147598815|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.543
74088251|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.29|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.65|-1.29|<.0001
73970971|NCT05139810|147481977|SUPERIORITY||Odds Ratio (OR)|14.8|||<|0.001|TWO_SIDED|95.0|3.15|69.41|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 50% Reduction||69.41|3.15|<0.001
73970972|NCT05139810|147481977|SUPERIORITY||Odds Ratio (OR)|34.74|||<|0.001|TWO_SIDED|95.0|7.32|164.87|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 70% Reduction||164.87|7.32|<0.001
73970973|NCT05139810|147481977|SUPERIORITY||Odds Ratio (OR)|9.17|||=|0.004|TWO_SIDED|95.0|2.05|41.09|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 70% Reduction||41.09|2.05|=0.004
73970974|NCT05139810|147481977|SUPERIORITY||Odds Ratio (OR)|17.04|||<|0.001|TWO_SIDED|95.0|3.36|86.42|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 90% Reduction||86.42|3.36|<0.001
73970975|NCT05139810|147481977|SUPERIORITY||Odds Ratio (OR)|8.7|||=|0.014|TWO_SIDED|95.0|1.56|48.52|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 90% Reduction||48.52|1.56|=0.014
73970976|NCT05139810|147481978|SUPERIORITY||IC HAE attack rate ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.03|0.234|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.234|0.030|<0.001
73970977|NCT05139810|147481978|SUPERIORITY||IC HAE attack rate ratio|0.33|||=|0.004|TWO_SIDED|95.0|0.155|0.706|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.706|0.155|=0.004
73970978|NCT05139810|147481980|SUPERIORITY||Treatment difference|-18.56|||<|0.001|TWO_SIDED|95.0|-27.673|-9.454|||Mixed model with repeated measures(MMRM)|||||-9.454|-27.673|<0.001
73970979|NCT05139810|147481980|SUPERIORITY||Treatment difference|-13.65|||=|0.01|TWO_SIDED|95.0|-24.024|-3.286|||MMRM|||||-3.286|-24.024|=0.010
73970980|NCT05566639|147481987|NON_INFERIORITY|Noninferiority margin = 10%|Relative vaccine efficacy (rVE)|1.7||||0.1715|TWO_SIDED|95.0|-24.1|22.2|||Stratified Cox proportional hazards||rVE = 100 \* (1 - HR) % was defined as the percent reduction in the hazard (mRNA-1010 vs active comparator), where HR was the hazard ratio between mRNA-1010 vs the active comparator.|||22.2|-24.1|0.1715
73970981|NCT04731818|147482000|SUPERIORITY||Mean Difference (Final Values)|0.0001|||<|0.0001|TWO_SIDED|||||analyzed by 1-way repeated measures analysis of variance (ANOVA) with post hoc Tukey multiple comparison test|ANOVA|1 way repeated measures ANOVA||||||<0.0001
74022917|NCT00190775|147598816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28|STANDARD_ERROR_OF_MEAN|1.05||0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.||||0.001
74022918|NCT00190775|147598817|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
74022919|NCT00190775|147598817|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.134
74022920|NCT00190775|147598818|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.056
74022921|NCT00190775|147598818|SUPERIORITY_OR_OTHER|||||||0.459||95.0||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.459
74022922|NCT00190775|147598818|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.435
74022923|NCT00190775|147598818|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.677
74022924|NCT00190775|147598818|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.376
74022925|NCT00190775|147598818|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.176
74022926|NCT00190775|147598818|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.030
73846940|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.0878|TWO_SIDED|95.0|-0.19|0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours||0.01|-0.19|0.0878
74022927|NCT00190775|147598818|SUPERIORITY_OR_OTHER|||||||0.434||95.0||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.434
74022928|NCT00190775|147598819|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.578
74022929|NCT00190775|147598819|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.062
74022930|NCT00190775|147598819|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.567
74022931|NCT00190775|147598819|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.383
73899313|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.612|TWO_SIDED|95.0|0.1|131.03|||Fisher Exact|||Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||131.03|0.10|0.612
73899314|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|19.66|||Fisher Exact|||Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||19.66|0.00|1.000
73899315|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.187|TWO_SIDED|95.0|0.66|7.3|||Fisher Exact|||Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.30|0.66|0.187
73899316|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.73||||0.399|TWO_SIDED|95.0|0.48|6.43|||Fisher Exact|||Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.43|0.48|0.399
74022932|NCT00190775|147598819|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.963
74022933|NCT00190775|147598819|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.075
74022934|NCT00190775|147598819|SUPERIORITY_OR_OTHER|||||||0.854||95.0||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.854
74022935|NCT00190775|147598819|SUPERIORITY_OR_OTHER|||||||0.671||95.0||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.671
74022936|NCT00190775|147598820|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.280
74022937|NCT00190775|147598820|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.34
74022938|NCT00190775|147598821|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.103
74022939|NCT00190775|147598821|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.182
74022940|NCT00190775|147598821|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.161
74022941|NCT00190775|147598821|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.472
74022942|NCT00190775|147598821|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.949
74022943|NCT00190775|147598821|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.848
74022944|NCT00190775|147598821|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.050
74022945|NCT00190775|147598821|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.840
74022946|NCT00190775|147598822|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.785
74022947|NCT00190775|147598822|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.081
74022948|NCT00190775|147598822|SUPERIORITY_OR_OTHER|||||||0.518||95.0||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.518
74022949|NCT00190775|147598822|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.883
74022950|NCT00190775|147598822|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.439
74022951|NCT00190775|147598822|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.167
74022952|NCT00190775|147598822|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.381
74084389|NCT02102932|147721994|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.75|STANDARD_DEVIATION|11.2||0|TWO_SIDED|90.0|98.18|109.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||109.63|98.18|0.0000
74022953|NCT00190775|147598822|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.906
74022954|NCT00190775|147598823|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.420
74022955|NCT00190775|147598823|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.249
74022956|NCT00190775|147598823|SUPERIORITY_OR_OTHER|||||||0.927||95.0||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.927
74022957|NCT00190775|147598823|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.205
74022958|NCT00190775|147598823|SUPERIORITY_OR_OTHER|||||||0.673||95.0||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.673
74022959|NCT00190775|147598823|SUPERIORITY_OR_OTHER|||||||0.881||95.0||||P-Value for Parent Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.881
74022960|NCT00190775|147598823|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.808
74022961|NCT00190775|147598823|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.498
74022962|NCT00190775|147598823|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.283
74022963|NCT00190775|147598824|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.784
74022964|NCT00190775|147598824|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.864
74022965|NCT00190775|147598824|SUPERIORITY_OR_OTHER|||||||0.884||95.0||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.884
74022966|NCT00190775|147598824|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.072
74022967|NCT00190775|147598824|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.120
74022968|NCT00190775|147598824|SUPERIORITY_OR_OTHER|||||||0.925||95.0||||P-Value Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.925
74022969|NCT00190775|147598824|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.444
74022970|NCT00190775|147598824|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.166
74022971|NCT00190775|147598824|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.875
74022972|NCT00190775|147598825|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.895
74022973|NCT00190775|147598825|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.792
74022974|NCT00190775|147598825|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.318
73846941|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7498|TWO_SIDED|95.0|-0.09|0.12||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours||0.12|-0.09|0.7498
73846942|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.803|TWO_SIDED|95.0|-0.11|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours||0.09|-0.11|0.8030
73846943|NCT02949011|147239809|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3577|TWO_SIDED|95.0|-0.05|0.15||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours||0.15|-0.05|0.3577
73846944|NCT02949011|147239810|SUPERIORITY||Median Difference|-23.1||||0.0009||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough||||0.0009
73846945|NCT02949011|147239810|SUPERIORITY||Median Difference|-0.2||||0.4074||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough||||0.4074
73846946|NCT02949011|147239810|SUPERIORITY||Median Difference|-6.3||||0.2496||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat||||0.2496
73846947|NCT02949011|147239810|SUPERIORITY||Median Difference|0.9||||0.2963||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat||||0.2963
73846948|NCT02949011|147239810|SUPERIORITY||Median Difference|-10.6||||0.039||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache||||0.0390
73846949|NCT02949011|147239810|SUPERIORITY||Median Difference|2.0||||0.7877||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache||||0.7877
74022975|NCT00190775|147598825|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.914
74084390|NCT02102932|147721994|SUPERIORITY_OR_OTHER||Ratio of the geometric means|95.77|STANDARD_DEVIATION|12.8||0|TWO_SIDED|90.0|89.88|102.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||102.03|89.88|0.0000
73846950|NCT02949011|147239810|SUPERIORITY||Median Difference|-12.1||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion||||0.0017
73970982|NCT04159415|147482002|SUPERIORITY||Least Squares (LS) Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.8|2.4|||||Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model|||2.4|-1.8|
73970983|NCT04159415|147482003|SUPERIORITY||LS Mean Difference|38.1|STANDARD_ERROR_OF_MEAN|27.3|||TWO_SIDED|95.0|-21.3|97.5|||||Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model|||97.5|-21.3|
73970984|NCT04159415|147482004|SUPERIORITY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|29.0|||TWO_SIDED|95.0|-56.9|56.9|||||Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from ANCOVA model analyses of the different imputed data sets.|||56.9|-56.9|
73970985|NCT04159415|147482005|SUPERIORITY||Adjusted Mean Difference|17.8|STANDARD_ERROR_OF_MEAN|43.6|||TWO_SIDED|95.0|-67.6|103.2|||||Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.|||103.2|-67.6|
73970986|NCT06182033|147482028|OTHER|||||||0.84|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.84
73970987|NCT06182033|147482029|OTHER|||||||0.727|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.727
73970988|NCT06182033|147482030|OTHER|||||||0.205|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||These analyses use the assertiveness subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.205
73970989|NCT06182033|147482030|OTHER|||||||0.034|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||This analysis focused specifically on the behavior control subscale. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.034
73899317|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.07|15.25|||Fisher Exact|||Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||15.25|0.07|1.000
73899318|NCT00545129|147330095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.492|TWO_SIDED|95.0|0.0|3.57|||Fisher Exact|||Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.57|0.00|0.492
73899319|NCT00545129|147330097|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.68||0.188|TWO_SIDED|95.0|0.77|3.73|||Negative binomial regression|||Week 1: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||3.73|0.77|0.188
73899320|NCT00545129|147330097|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.81|STANDARD_ERROR_OF_MEAN|0.85||0.207|TWO_SIDED|95.0|0.72|4.54|||Negative binomial regression|||Week 2: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||4.54|0.72|0.207
73899321|NCT00545129|147330097|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.71|STANDARD_ERROR_OF_MEAN|0.92||0.317|TWO_SIDED|95.0|0.6|4.93|||Negative binomial regression|||Week 3: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||4.93|0.60|0.317
73899322|NCT00545129|147330097|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|0.7||0.554|TWO_SIDED|95.0|0.5|3.71|||Negative binomial regression|||Week 4: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||3.71|0.50|0.554
73899323|NCT00545129|147330097|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.35||0.581|TWO_SIDED|95.0|0.32|1.89|||Negative binomial regression|||Week 5: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.89|0.32|0.581
73899324|NCT00545129|147330097|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|0.27||0.252|TWO_SIDED|95.0|0.26|1.43|||Negative binomial regression|||Week 6: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.43|0.26|0.252
73899325|NCT00545129|147330097|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.31||0.365|TWO_SIDED|95.0|0.26|1.64|||Negative binomial regression|||Week 7: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.64|0.26|0.365
73899326|NCT00545129|147330097|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.25||0.212|TWO_SIDED|95.0|0.25|1.36|||Negative binomial regression|||Week 8: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.36|0.25|0.212
73899327|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.215|TWO_SIDED|95.0|-0.13|0.55|||ANCOVA|||Change at Week 2 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.55|-0.13|0.215
73899328|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.947|TWO_SIDED|95.0|-0.45|0.42|||ANCOVA|||Change at Week 4 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.42|-0.45|0.947
73899329|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.341|TWO_SIDED|95.0|-0.56|0.2|||ANCOVA|||Change at Week 6 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.20|-0.56|0.341
73899330|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.24||0.18|TWO_SIDED|95.0|-0.83|0.17|||ANCOVA|||Change at Week 2 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.17|-0.83|0.180
73970990|NCT06182033|147482030|OTHER|||||||0.099|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||These analyses use the Task Orientation subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.099
73899331|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.509|TWO_SIDED|95.0|-0.43|0.84|||ANCOVA|||Change at Week 4 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.84|-0.43|0.509
73899332|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.767|TWO_SIDED|95.0|-0.62|0.82|||ANCOVA|||Change at Week 6 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.82|-0.62|0.767
73899333|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.25||0.108|TWO_SIDED|95.0|-0.11|0.95|||ANCOVA|||Change at Week 2 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.95|-0.11|0.108
73899334|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.37||0.28|TWO_SIDED|95.0|-1.26|0.41|||ANCOVA|||Change at Week 4 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.41|-1.26|0.280
73846951|NCT02949011|147239810|SUPERIORITY||Median Difference|1.5||||0.8119||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion||||0.8119
73846952|NCT02949011|147239810|SUPERIORITY||Median Difference|-3.6||||0.007||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills||||0.0070
73846953|NCT02949011|147239810|SUPERIORITY||Median Difference|-0.7||||0.9191||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills||||0.9191
73846954|NCT02949011|147239810|SUPERIORITY||Median Difference|-7.7||||0.0232||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain||||0.0232
73846955|NCT02949011|147239810|SUPERIORITY||Median Difference|4.0||||0.5436||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain||||0.5436
73846956|NCT02949011|147239810|SUPERIORITY||Median Difference|-7.5||||0.0207||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue||||0.0207
73846957|NCT02949011|147239810|SUPERIORITY||Median Difference|-1.9||||0.371||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue||||0.3710
73846958|NCT02949011|147239811|SUPERIORITY||Median Difference|-23.4||||0.4634||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.4634
73846959|NCT02949011|147239811|SUPERIORITY||Median Difference|-0.6||||0.6386||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.6386
73899335|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.57||0.747|TWO_SIDED|95.0|-1.53|1.15|||ANCOVA|||Change at Week 6 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.15|-1.53|0.747
74022976|NCT00190775|147598825|SUPERIORITY_OR_OTHER|||||||0.961||95.0||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.961
73846960|NCT02949011|147239812|SUPERIORITY|||||||0.0112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||||||0.0112
73846961|NCT02949011|147239812|SUPERIORITY|||||||0.8478||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||||||0.8478
73846962|NCT02949011|147239813|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||<0.0001
73846963|NCT02949011|147239813|SUPERIORITY|||||||0.2558||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.2558
73846964|NCT00163189|147239815|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Student's paired t-test|||Month 36||||<0.001
73846965|NCT00163189|147239816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Student's paired t-test|||Month 36||||0.008
73899336|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.991|TWO_SIDED|95.0|-0.87|0.88|||ANCOVA|||Change at Week 2 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.88|-0.87|0.991
73846966|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|-0.21||||0.92|TWO_SIDED|95.0|-4.48|4.05|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for FACT-B 3 month Total Score||4.05|-4.48|0.92
73846967|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|1.37||||0.57|TWO_SIDED|95.0|-3.41|6.15|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for FACT-B 6 month Total Score||6.15|-3.41|0.57
73846968|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|1.18||||0.62|TWO_SIDED|95.0|-3.54|5.89|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is for the Fact-B 12 month Total Score||5.89|-3.54|0.62
73899337|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.27||0.335|TWO_SIDED|95.0|-0.41|0.99|||ANCOVA|||Change at Week 4 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.99|-0.41|0.335
74022977|NCT00190775|147598825|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.807
73899338|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.7||0.159|TWO_SIDED|95.0|-4.57|1.48|||ANCOVA|||Change at Week 6 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.48|-4.57|0.159
73846969|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|0.12||||0.83|TWO_SIDED|95.0|-0.99|1.23|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Physical Well-Being Subscale||1.23|-0.99|0.83
73846970|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.15||||0.82|TWO_SIDED|95.0|-1.15|1.45|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for the Fact-B 6 month Physical Well-Being Subscale||1.45|-1.15|0.82
73846971|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.13||||0.84|TWO_SIDED|95.0|-1.41|1.15|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for the Fact-B 12 month Physical Well-Being Subscale||1.15|-1.41|0.84
73846972|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.17||||0.77|TWO_SIDED|95.0|-1.31|0.96|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Social/Family Well-Being Subscale||0.96|-1.31|0.77
73846973|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.56||||0.42|TWO_SIDED|95.0|-1.91|0.79|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 6 month Social/Family Well-Being Subscale||0.79|-1.91|0.42
73846974|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.08||||0.9|TWO_SIDED|95.0|-1.41|1.24|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Social/Family Well-Being Subscale||1.24|-1.41|0.90
73846975|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.05||||0.9|TWO_SIDED|95.0|-0.76|0.87|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Emotional Well-Being Subscale||0.87|-0.76|0.90
73846976|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.58||||0.25|TWO_SIDED|95.0|-0.4|1.56|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact B 6 month Emotional Well-Being Subscale||1.56|-0.40|0.25
73846977|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.6||||0.22|TWO_SIDED|95.0|-0.36|1.57|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Emotional Well-Being Subscale||1.57|-0.36|0.22
73846978|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.14||||0.81|TWO_SIDED|95.0|-1.05|1.34|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for Fact-B 3 month Functional Well-Being Subscale||1.34|-1.05|0.81
73846979|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.54||||0.45|TWO_SIDED|95.0|-0.85|1.94|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for Fact-B 6 month Functional Well-Being Subscale||1.94|-0.85|0.45
73899339|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.23||0.136|TWO_SIDED|95.0|-0.16|0.94|||ANCOVA|||Change at Week 2 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.94|-0.16|0.136
73899340|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.37||0.186|TWO_SIDED|95.0|-3.46|5.9|||ANCOVA|||Change at Week 6 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||5.90|-3.46|0.186
73899341|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.48||0.292|TWO_SIDED|95.0|-1.52|0.49|||ANCOVA|||Change at Week 2 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.49|-1.52|0.292
74022978|NCT00190775|147598825|SUPERIORITY_OR_OTHER|||||||0.827||95.0||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.827
74022979|NCT00190775|147598826|SUPERIORITY_OR_OTHER|||||||0.828||95.0||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.828
74022980|NCT00190775|147598826|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.401
74022981|NCT00190775|147598826|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.300
73846980|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.11||||0.87|TWO_SIDED|95.0|-1.48|1.26|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Functional Well-Being Subscale||1.26|-1.48|0.87
73846981|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.16||||0.8|TWO_SIDED|95.0|-1.13|1.45|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Breast Cancer Subscale||1.45|-1.13|0.80
73846982|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.73||||0.35|TWO_SIDED|95.0|-0.79|2.24|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 6 month Breast Cancer Subscale||2.24|-0.79|0.35
73846983|NCT02941614|147239866|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.6||||0.42|TWO_SIDED|95.0|-0.88|2.09|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Breast Cancer Subscale||2.09|-0.88|0.42
73846984|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|-0.03||||0.59|TWO_SIDED|95.0|-0.15|0.09||We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects|Mixed Models Analysis|||Data below is for the BCPT survey 3 month Total Score.||0.09|-0.15|0.59
73846985|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.05||||0.47|TWO_SIDED|95.0|-0.09|0.19|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Total Score||0.19|-0.09|0.47
74022982|NCT00190775|147598826|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.575
74022983|NCT00190775|147598826|SUPERIORITY_OR_OTHER|||||||0.772||95.0||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.772
74022984|NCT00190775|147598826|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.918
74022985|NCT00190775|147598826|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.636
74022986|NCT00190775|147598827|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||P-Value for Total ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.583
73846986|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.06||||0.37|TWO_SIDED|95.0|-0.2|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Total Score||0.07|-0.20|0.37
73846987|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.05||||0.65|TWO_SIDED|95.0|-0.26|0.17|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Hot Flashes Sub-Scale||0.17|-0.26|0.65
73846988|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.08||||0.54|TWO_SIDED|95.0|-0.17|0.33|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Hot Flashes Sub-Scale||0.33|-0.17|0.54
73846989|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.02||||0.87|TWO_SIDED|95.0|-0.27|0.22|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Hot Flashes Sub-Scale||0.22|-0.27|0.87
73846990|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.06||||0.32|TWO_SIDED|95.0|-0.17|0.06|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Nausea Sub-Scale||0.06|-0.17|0.32
73846991|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.0||||0.96|TWO_SIDED|95.0|-0.15|0.14|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Nausea Sub-Scale||0.14|-0.15|0.96
73846992|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.32|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Nausea Sub-Scale||0.07|-0.21|0.32
73846993|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.44|TWO_SIDED|95.0|-0.24|0.11|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Bladder Control Sub-Scale||0.11|-0.24|0.44
73846994|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.38|TWO_SIDED|95.0|-0.11|0.3|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Bladder Control Sub-Scale||0.30|-0.11|0.38
73846995|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.47|TWO_SIDED|95.0|-0.28|0.13|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is for the BCPT survey 12 month Bladder Control Sub-Scale||0.13|-0.28|0.47
73846996|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.17||||0.13|TWO_SIDED|95.0|-0.39|0.05|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Vaginal Problems Sub-Scale||0.05|-0.39|0.13
73846997|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.29||||0.03|TWO_SIDED|95.0|-0.55|-0.02|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Vaginal Problems Sub-Scale||-0.02|-0.55|0.03
73846998|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.19||||0.14|TWO_SIDED|95.0|-0.45|0.06|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Vaginal Problems Sub-Scale||0.06|-0.45|0.14
73846999|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.07||||0.53|TWO_SIDED|95.0|-0.14|0.28|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Musculoskeletal Pain Sub-Scale||0.28|-0.14|0.53
73847000|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.1||||0.47|TWO_SIDED|95.0|-0.16|0.35|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Musculoskeletal Pain Sub-Scale||0.35|-0.16|0.47
73847001|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.07||||0.57|TWO_SIDED|95.0|-0.18|0.33|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Musculoskeletal Pain Sub-Scale||0.33|-0.18|0.57
73847002|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.02||||0.85|TWO_SIDED|95.0|-0.18|0.21|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Cognitive Problems Sub-Scale||0.21|-0.18|0.85
73847003|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.1||||0.38|TWO_SIDED|95.0|-0.12|0.32|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Cognitive Problems Sub-Scale||0.32|-0.12|0.38
74084391|NCT02102932|147721995|SUPERIORITY_OR_OTHER||Ratio of the geometric means|106.44|STANDARD_DEVIATION|11.8||0|TWO_SIDED|90.0|100.44|112.8||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.80|100.44|0.0000
74088252|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.28|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.65|-1.28|<.0001
73970991|NCT06182033|147482030|OTHER|||||||0.209|||||||Regression, Linear|||This analysis used peer social skills subscale as the outcome in the model. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.209
73970992|NCT06182033|147482031|OTHER|||||||0.82|||||||Multilevel Model|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.82
73970993|NCT06182033|147482032|OTHER|||||||0.67|||||||Multilevel Model|Kenward-Rogers and Restricted Maximum Likelihood adjustments in light of small sample size to reduce error likelihood.||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.67
73970994|NCT06182033|147482033|OTHER|||||||0.024|||||||Regression, Linear|Kenward-Rogers and Restricted Maximum Likelihood to account for the small sample size.||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.024
73970995|NCT06182033|147482034|OTHER|||||||0.013|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.013
73970996|NCT01456949|147482051|SUPERIORITY||Kaplan-Meier (product-limit) estimator|66.9|||<|0.001|TWO_SIDED|95.0|61.6|71.7|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||71.7|61.6|<0.001
73970997|NCT01456949|147482052|SUPERIORITY||Kaplan-Meier (product-limit) estimator|2.3|||<|0.001|TWO_SIDED|95.0|1.1|4.5|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||4.5|1.1|<0.001
73970998|NCT01456949|147482053|OTHER|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Freedom from MAFE's was estimated using Kaplan-Meier methods.|||
73970999|NCT01456949|147482054|OTHER|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Chronic treatment success was estimated at one and two years using Kaplan-Meier methods.|||
73971000|NCT02723591|147482055|SUPERIORITY||Odds Ratio (OR)|1.115||||0.5777|TWO_SIDED|95.0|0.76|1.636|||Regression, Logistic|||Logistic regression with DSA/IA occurrence by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant calculated panel reactivity antibody (cPRA) as fixed effects, and pooled site as a random effect with standard variance components covariance type.||1.636|0.760|0.5777
73971001|NCT02723591|147482058|SUPERIORITY|||||||0.6618|||||||Fisher Exact|||P-values obtained from a 2x3 Exact Test of treatment by strength levels.||||0.6618
73971002|NCT02723591|147482063|SUPERIORITY||Odds Ratio (OR)|1.038||||0.8518|TWO_SIDED|95.0|0.7|1.539|||Regression, Logistic|||Logistic regression with IA occurrence by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||1.539|0.700|0.8518
73971003|NCT02723591|147482066|SUPERIORITY|||||||1|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||1.0000
73971004|NCT02723591|147482067|SUPERIORITY|||||||0.475|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||0.4750
73971005|NCT02723591|147482068|SUPERIORITY|||||||0.0939|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||0.0939
73971006|NCT02723591|147482071|SUPERIORITY||Odds Ratio (OR)|1.431||||0.116|TWO_SIDED|95.0|0.915|2.24|||Regression, Logistic|||Logistic regression with occurrence of eGFR \< 50 by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||2.240|0.915|0.1160
73971007|NCT02723591|147482072|SUPERIORITY||Odds Ratio (OR)|1.212||||0.4995|TWO_SIDED|95.0|0.693|2.12|||Regression, Logistic|||Logistic regression with occurrence of 5-point eGFR decline by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||2.120|0.693|0.4995
73971008|NCT02723591|147482090|SUPERIORITY|||||||0.6327|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.6327
73971009|NCT02723591|147482091|SUPERIORITY|||||||0.9701|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.9701
73847004|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.13||||0.23|TWO_SIDED|95.0|-0.35|0.09|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Cognitive Problems Sub-Scale||0.09|-0.35|0.23
73847005|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.14||||0.18|TWO_SIDED|95.0|-0.35|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Weight Problems Sub-Scale||0.07|-0.35|0.18
73960067|NCT01087762|147455750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.49|-1.5||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.50|-2.49|<0.001
73960068|NCT01087762|147455751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.20|-0.60|<0.001
73960069|NCT01087762|147455752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.66|-0.23||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.23|-0.66|<0.001
73960070|NCT02311972|147455755|SUPERIORITY|Mean axillary admission temperature||||||0.7294|||||||t-test, 2 sided|||||||0.7294
73960071|NCT02311972|147455756|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||||||0.2360
73960072|NCT02311972|147455757|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73960073|NCT02311972|147455758|SUPERIORITY|||||||0.1089|||||||t-test, 2 sided|||||||0.1089
73960074|NCT02311972|147455759|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73960075|NCT02311972|147455760|SUPERIORITY|||||||0.4947|||||||t-test, 2 sided|||||||0.4947
73960076|NCT02311972|147455761|SUPERIORITY|Infant 007|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73960077|NCT02311972|147455761|SUPERIORITY|Infant 010|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73960078|NCT02311972|147455761|SUPERIORITY|Infant 015|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73960079|NCT02311972|147455761|SUPERIORITY|Infant 039|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73960080|NCT02311972|147455761|SUPERIORITY|Infant 040||||||0.3947|||||||t-test, 2 sided|||||||0.3947
73960081|NCT01391130|147455793|SUPERIORITY||Hazard Ratio (HR)|1.2149||||0.4318|TWO_SIDED|95.0|0.7462|1.9779|||Log Rank|||||1.9779|0.7462|0.4318
73960082|NCT03478696|147455798|NON_INFERIORITY|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.011|STANDARD_ERROR_OF_MEAN|0.0154|||TWO_SIDED|95.0|-0.02|0.041|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.|||0.041|-0.020|
73960083|NCT03478696|147455799|SUPERIORITY||Mean Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.0122||0.037|TWO_SIDED|95.0|0.002|0.049||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2|||0.049|0.002|0.037
73960084|NCT03478696|147455799|SUPERIORITY||Mean Difference (Net)|0.063|STANDARD_ERROR_OF_MEAN|0.0134|<|0.001|TWO_SIDED|95.0|0.036|0.089||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28|||0.089|0.036|<0.001
74084392|NCT02102932|147721995|SUPERIORITY_OR_OTHER||Ratio of the geometric means|110.78|STANDARD_DEVIATION|13.2||0.0021|TWO_SIDED|90.0|103.8|118.24||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||118.24|103.80|0.0021
73960085|NCT03478696|147455799|SUPERIORITY||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.0144|<|0.001|TWO_SIDED|95.0|0.026|0.083||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84|||0.083|0.026|<0.001
73960086|NCT03478696|147455799|SUPERIORITY||Mean Difference (Net)|0.051|STANDARD_ERROR_OF_MEAN|0.0157||0.001|TWO_SIDED|95.0|0.021|0.082||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85|||0.082|0.021|0.001
74022987|NCT00190775|147598827|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||P-Value for Hyperactive-Impulsive Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.997
74022988|NCT00190775|147598827|SUPERIORITY_OR_OTHER|||||||0.333||95.0||||P-Value for Inattention Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.333
74022989|NCT00190775|147598828|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-Value for Oppositional Defiant Disorder Flag|Fisher Exact|||||||.792
74022990|NCT00190775|147598828|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||P-Value for Conduct Disorder Flag.|Fisher Exact|||||||0.675
74022991|NCT00190775|147598829|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.875
74022992|NCT00190775|147598829|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.569
74022993|NCT00190775|147598829|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.399
74022994|NCT00190775|147598830|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.365
74022995|NCT00190775|147598830|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.620
74022996|NCT00190775|147598830|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.462
74022997|NCT00190775|147598831|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-Value for Total Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.001
74022998|NCT00190775|147598831|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for Hyperactivity Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.004
74022999|NCT00190775|147598831|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Inattention Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
74023000|NCT00190775|147598831|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
74023001|NCT00190775|147598831|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Hyperactivity Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
74023002|NCT00190775|147598831|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Inattention Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
74023003|NCT00190775|147598832|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 8 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
74023004|NCT00190775|147598832|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
74023005|NCT00190775|147598833|SUPERIORITY_OR_OTHER|||||||0.553||95.0||||P-Value for 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.553
74023006|NCT00190775|147598833|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.797
74023007|NCT00190775|147598834|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-Value for State Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.108
74023008|NCT00190775|147598834|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-Value for Trait Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.026
74023009|NCT00190775|147598834|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-Value is for State Anxiety Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.897
74023010|NCT00190775|147598834|SUPERIORITY_OR_OTHER|||||||0.171||95.0||||P-Value is for Trait Anxiety Score at 24 weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.171
74023011|NCT00190775|147598835|SUPERIORITY_OR_OTHER|||||||0.892||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.892
74023012|NCT00190775|147598835|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.003
74023013|NCT00190775|147598835|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.007
74023014|NCT00190775|147598835|SUPERIORITY_OR_OTHER|||||||0.533||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.533
74023015|NCT00190775|147598835|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.054
74023016|NCT00190775|147598835|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.012
74023017|NCT00190775|147598835|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.457
74023018|NCT00190775|147598835|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.001
74023019|NCT00190775|147598835|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.021
74023020|NCT00190775|147598835|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.710
74023021|NCT00190775|147598835|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||<0.001
74023022|NCT00190775|147598835|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
74023023|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.722
74023024|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.011
73847006|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.12||||0.35|TWO_SIDED|95.0|-0.36|0.13|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Weight Problems Sub-Scale||0.13|-0.36|0.35
73847007|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.12||||0.34|TWO_SIDED|95.0|-0.36|0.12|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Weight Problems Sub-Scale||0.12|-0.36|0.34
73847008|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.22|TWO_SIDED|95.0|-0.06|0.25|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Arm Problems Sub-Scale||0.25|-0.06|0.22
73847009|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.11||||0.26|TWO_SIDED|95.0|-0.08|0.29|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Arm Problems Sub-Scale||0.29|-0.08|0.26
73847010|NCT02941614|147239867|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.34|TWO_SIDED|95.0|-0.09|0.27|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Arm Problems Sub-Scale||0.27|-0.09|0.34
73847011|NCT02941614|147239868|OTHER||Rate Ratio|0.86||||0.006|TWO_SIDED|95.0|0.77|0.96|||Regression, Poisson|||||0.96|0.77|0.006
73847012|NCT02941614|147239869|OTHER||Rate Ratio|1.07||||0.356|TWO_SIDED|95.0|0.93|1.07|||Regression, Poisson|||||1.07|0.93|0.356
73847013|NCT02941614|147239870|OTHER||Rate Ratio|1.02||||0.919|TWO_SIDED|95.0|0.73|1.41|||Regression/Poisson|||||1.41|0.73|0.919
73847014|NCT02941614|147239871|OTHER||Rate Ratio|1.16||||0.367|TWO_SIDED|95.0|0.84|1.62|||Regression, Poisson|||The data below applies to Emergency Department visits||1.62|0.84|0.367
74023025|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
74023026|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-Value for Hyper/Impulsive Scale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.779
74023027|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.004
74023028|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.002
73847015|NCT02941614|147239871|OTHER||Rate Ratio|0.84||||0.497|TWO_SIDED|95.0|0.51|1.38|||Regression, Poisson|||The data below applies to Urgent Care visits||1.38|0.51|0.497
73847016|NCT01908140|147239891|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin=-0,055 L|Mean Difference (Final Values)|0.093|||<|0.001|TWO_SIDED|95.0|0.063|0.123|||MMRM|If non-inferiority on the PP was achieved then switch to superiority was tested on the ITT.||This sample size of 900 had 90% power to show that the lower bound of the two-sided 95% confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in Peak FEV1 at 24 weeks is above -0,055 L||0.123|0.063|<0.001
73847017|NCT01908140|147239892|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority limit -0.5 units|Mean Difference (Final Values)|-0.001|||>|0.05|TWO_SIDED|95.0|-0.46|0.46|||MMRM|||The total sample size provided 81% nominal power to show that the lower bound of the two-sided 95 confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in transitional dyspnoea index (TDI) at 24 weeks is above -0,5||0.46|-0.46|>0.05
73847018|NCT02013609|147239893|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in MADRS total score at Week 12 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
73847019|NCT02013609|147239894|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
73847020|NCT02013609|147239899|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction.||Statistical analysis at Week 12.||||<0.0001
73847021|NCT02013609|147239900|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
74023029|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.716||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.716
73899342|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.38||0.225|TWO_SIDED|95.0|-0.34|1.3|||ANCOVA|||Change at Week 4 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.30|-0.34|0.225
73899343|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.36||0.517|TWO_SIDED|95.0|-0.58|1.07|||ANCOVA|||Change at Week 6 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.07|-0.58|0.517
73971010|NCT02723591|147482092|SUPERIORITY|||||||0.3127|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.3127
73847022|NCT02013609|147239901|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The p-value is the same for each of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities|Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12 of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities||||<0.0001
73847023|NCT02013609|147239902|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
73847024|NCT02013609|147239903|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12||||<0.0001
73847025|NCT02013609|147239904|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12||||<0.0001
73847026|NCT02013609|147239905|SUPERIORITY_OR_OTHER|||||||0.3439|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (Go cues)||||0.3439
73847027|NCT02013609|147239905|SUPERIORITY_OR_OTHER|||||||0.3385|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (No-Go cues)||||0.3385
73847028|NCT02013609|147239906|SUPERIORITY_OR_OTHER|||||||0.2052|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (Go cues)||||0.2052
73847029|NCT02013609|147239906|SUPERIORITY_OR_OTHER|||||||0.3224|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (No-Go cues)||||0.3224
73847030|NCT02013609|147239907|SUPERIORITY_OR_OTHER|||||||0.3169|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12||||0.3169
73847031|NCT02013609|147239908|SUPERIORITY_OR_OTHER|||||||0.3352|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12||||0.3352
73847032|NCT02013609|147239909|SUPERIORITY_OR_OTHER|||||||0.3517|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task k value||||0.3517
73847033|NCT02013609|147239909|SUPERIORITY_OR_OTHER|||||||0.3799|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task h value||||0.3799
73847034|NCT02013609|147239910|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for food)||||0.2610
73847035|NCT02013609|147239910|SUPERIORITY_OR_OTHER|||||||0.8138|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)||||0.8138
73847036|NCT02013609|147239911|SUPERIORITY_OR_OTHER|||||||0.8138|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)||||0.8138
73847037|NCT02013609|147239912|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
73847038|NCT00783432|147239915|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||This is the Baseline P-Value|ANOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.368
73847039|NCT00783432|147239915|SUPERIORITY_OR_OTHER|||||||0.327||95.0||||This P-Value if for Month 1|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.327
73847040|NCT00783432|147239915|SUPERIORITY_OR_OTHER|||||||0.991||95.0||||This P-Value is for Month 3|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.991
73847041|NCT00783432|147239915|SUPERIORITY_OR_OTHER|||||||0.168||95.0||||This P-Value is for Month 6|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.168
73847042|NCT00783432|147239915|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||This P-Value is for Month 9|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.319
73847043|NCT00783432|147239915|SUPERIORITY_OR_OTHER|||||||0.725||||||This P-Value is for Month 12/ET|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.725
73847044|NCT01436110|147239916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.43|TWO_SIDED|95.0|-0.055|0.128|||ANCOVA|||||0.128|-0.055|0.430
73899344|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.58||1|TWO_SIDED|95.0|-2.48|2.48|||ANCOVA|||Change at Week 2 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||2.48|-2.48|1.000
73847045|NCT01436110|147239916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102||||0.03|TWO_SIDED|95.0|0.01|0.194|||ANCOVA|||||0.194|0.010|0.030
73847046|NCT03273907|147239929|SUPERIORITY|The primary null hypothesis tested was that the observed rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability is greater than or equal to the performance target rate of 7.00 percent.||||||0.187|||||||Exact one-sided binomial test|P-value is provided from exact one-sided binomial test with type I error 0.05 comparing CyPass System with performance criterion of 7.00 percent.||||||0.1870
73847047|NCT02581891|147239938|NON_INFERIORITY|The non-inferiority margin is set to 5 letters.|LS mean difference|-2.0199|STANDARD_ERROR_OF_MEAN|1.3833||0.0162|TWO_SIDED|95.0|-4.747|0.7073|||ANCOVA|||||0.7073|-4.7470|0.0162
73847048|NCT03498716|147239972|SUPERIORITY|Stratified Analysis: The stratification factors used in the analysis are axillary nodal status, surgery (breast conserving vs. mastectomy),and tumor PD-L1 status.|Hazard Ratio (HR)|1.11||||0.3846|TWO_SIDED|95.0|0.87|1.42|||Log Rank|||||1.42|0.87|0.3846
73847049|NCT00265850|147239986|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.08|TWO_SIDED|95.0|0.77|1.01|||Log Rank|||||1.01|0.77|0.08
73847050|NCT00265850|147239987|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.45|TWO_SIDED|95.0|0.84|1.08|||Log Rank|||||1.08|0.84|0.45
73847051|NCT01657305|147239994|SUPERIORITY_OR_OTHER||||||<|0.0001||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments.~Negative values for the intra-individual time difference indicate faster healing of the Oleogel-S10-treated wound half.~For right-censored observations (no wound closure observed in blinded photo evaluation), wound closure was conservatively calculated as +1 day after the last photo."||||<0.0001
73847052|NCT01657305|147239998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_DEVIATION|13.4|<|0.0001|TWO_SIDED|95.0|6.0|11.2||Day 7|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||11.2|6.0|<0.0001
73847053|NCT01657305|147239998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_DEVIATION|17.0|<|0.0001|TWO_SIDED|95.0|6.9|13.4||Day 10|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||13.4|6.9|<0.0001
73847054|NCT01657305|147239998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|17.0|<|0.0001|TWO_SIDED|95.0|4.6|11.1||Day 14|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||11.1|4.6|<0.0001
73899345|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|95.0|-1.01|-0.99|||ANCOVA|||Change at Week 4 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||-0.99|-1.01|<0.001
74023030|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.071
74023031|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.034
73847055|NCT01657305|147239998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_DEVIATION|18.3|<|0.0001|TWO_SIDED|95.0|3.9|10.9||Day 18|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||10.9|3.9|<0.0001
73847056|NCT01657305|147239998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_DEVIATION|14.1|<|0.0001|TWO_SIDED|95.0|3.7|9.1||Day 21|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||9.1|3.7|<0.0001
73847057|NCT01657305|147239998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|12.9|=|0.0021|TWO_SIDED|95.0|1.5|6.4||Day 28|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||6.4|1.5|=0.0021
73847058|NCT01180127|147240020|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Repeated measures ANOVA|||Repeated measures ANOVA for the interaction of time (baseline vs 12 week) and flavanol group.||||.0001
73847059|NCT01180127|147240021|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED|||||The ANCOVA model included a main effect for both flavanol and exercise, so this p-value is for the effect of flavanol on Modbent controlling for baseline Modbent and exercise|ANCOVA|||ANCOVA used to test main effect of flavanol||||0.038
73847060|NCT01180127|147240021|SUPERIORITY_OR_OTHER|||||||0.815|TWO_SIDED|||||The ANCOVA included both a main effect for flavanol and exercise, so this p-value is for the test of exercise controlling for baseline Modbent and flavanol|ANCOVA|||ANCOVA used to test main effect of exercise||||0.815
73847061|NCT01180127|147240022|SUPERIORITY_OR_OTHER|||||||0.853|TWO_SIDED||||||ANCOVA|||ANCOVA for testing main effect of flavanol||||0.853
73847062|NCT01180127|147240022|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED||||||ANCOVA|||ANCOVA for testing main effect of exercise||||0.581
73847063|NCT01180127|147240023|SUPERIORITY_OR_OTHER|||||||0.237|TWO_SIDED||||||ANCOVA|||ANCOVA was used to test for an exercise effect.||||0.237
73847064|NCT01227057|147240030|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.029||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.||||.029
73899346|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.43||0.362|TWO_SIDED|95.0|-0.75|1.63|||ANCOVA|||Change at Week 2 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.63|-0.75|0.362
73847065|NCT01227057|147240031|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.04||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.||||.04
73847066|NCT01227057|147240032|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.|||||>|0.1||||||P value is for the group x time interaction.|ANOVA|||||||>.1
73847067|NCT02271529|147240033|NON_INFERIORITY_OR_EQUIVALENCE|Under the assumption that the mean percent change in stent length upon deployment being 0.2% with a standard deviation of 4%, type I error of 0.05, and two one-sided t-tests, a sample size of at least 30 stents provides power \> 0.90 to determine that the mean length change of stents deployed with the thumbwheel delivery system is within +/-10%.|Mean percent change|-1.0|||<|0.01|TWO_SIDED|95.0|-1.5|-0.4|||two one-sided t-tests|||||-0.4|-1.5|<0.01
73847068|NCT03768427|147240034|OTHER|Difference in least squares mean|Mean Difference (Final Values)|-19.5|||<|0.001|TWO_SIDED|95.0|-26.7|-12.3|||Constrained longitudinal model|||"This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (88 participants in arm Atorvastatin 10 mg - ezetimibe 10 mg/Ator 10 mg and 89 participants in arm Atorvastatin 10mg - Atorvastatin 20 mg)."|Difference in least squares mean is Atorvastatin 10 mg - EZ 10 mg/Ator 10 mg minus Atorvastatin 10mg - Atorvastatin 20 mg.|-12.3|-26.7|<0.001
73847069|NCT03768427|147240034|OTHER|Difference in least squares mean|Mean Difference (Final Values)|-15.9|||<|0.001|TWO_SIDED|95.0|-21.0|-10.7|||Constrained longitudinal model|||"This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (137 participants in arm Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg and 140 participants in arm Atorvastatin 20 mg - Atorvastatin 40 mg)."|Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg minus Atorvastatin 20 mg - Atorvastatin 40 mg.|-10.7|-21.0|<0.001
73847070|NCT01628523|147240038|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
73847071|NCT01685684|147240053|SUPERIORITY_OR_OTHER_LEGACY||Marginal Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|0.267|<|0.0001|TWO_SIDED||||||z-test|||||||<0.0001
73847072|NCT00902330|147240064|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Spearman correlation coefficients were computed for the biomarkers. P-Values shown are not adjusted for multiple comparisons. The a priori threshold for statistical significance was P less than 0.05. This information applies to all rows listed in the table.||||<0.05
73847073|NCT03950856|147240083|OTHER||Difference in Percentage|1.3||||0.538|TWO_SIDED|95.0|-3.3|4.8|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site erythema: V114 Combined Lots - Prevnar 13™||4.8|-3.3|0.538
73847074|NCT03950856|147240083|OTHER||Difference in Percentage|14.6|||<|0.001|TWO_SIDED|95.0|7.9|21.4|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site pain: V114 Combined Lots - Prevnar 13™||21.4|7.9|<0.001
73847075|NCT03950856|147240083|OTHER||Difference in Percentage|1.0||||0.686|TWO_SIDED|95.0|-4.3|5.3|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site swelling: V114 Combined Lots - Prevnar 13™||5.3|-4.3|0.686
73847076|NCT03950856|147240085|OTHER||Difference in Percentage|2.0||||0.272|TWO_SIDED|95.0|-1.9|4.7|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Arthralgia: V114 Combined Lots - Prevnar 13™||4.7|-1.9|0.272
73971011|NCT02723591|147482093|SUPERIORITY|||||||0.083|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.0830
73847077|NCT03950856|147240085|OTHER||Difference in Percentage|-0.7||||0.812|TWO_SIDED|95.0|-6.7|4.5|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Fatigue: V114 Combined Lots - Prevnar 13™||4.5|-6.7|0.812
73847078|NCT03950856|147240085|OTHER||Difference in Percentage|0.2||||0.947|TWO_SIDED|95.0|-5.6|5.0|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Headache: V114 Combined Lots - Prevnar 13™||5.0|-5.6|0.947
73847079|NCT03950856|147240085|OTHER||Difference in Percentage|5.2||||0.091|TWO_SIDED|95.0|-0.9|10.4|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Myalgia: V114 Combined Lots - Prevnar 13™||10.4|-0.9|0.091
73847080|NCT03950856|147240087|OTHER||Miettinen & Nurminen|0.0|||||TWO_SIDED|95.0|-1.6|0.2|||||V114 Combined Lots minus Prevnar 13™|V114 Combined Lots - Prevnar 13™||0.2|-1.6|
73899347|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|4.08||1|TWO_SIDED|95.0|-51.87|51.87|||ANCOVA|||Change at Week 4 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||51.87|-51.87|1.000
73899348|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|0.1||0.031|TWO_SIDED|95.0|-3.3|-0.76|||ANCOVA|||Change at Week 4 (Retching/Vomiting MDR): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||-0.76|-3.30|0.031
73899349|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.15||0.886|TWO_SIDED|95.0|-0.28|0.32|||ANCOVA|||Change at Week 2 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.32|-0.28|0.886
73847081|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.83|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.83|<0.001
73847082|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.87|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.87|<0.001
73847083|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.88|1.25||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 1: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.25|0.88|<0.001
73847084|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.75|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.97|0.75|<0.001
73847085|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.81|1.05||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.05|0.81|<0.001
73847086|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.95|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 3: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.23|0.95|<0.001
73847087|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.7|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.97|0.70|<0.001
74023032|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.938||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.938
73899350|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.21||0.66|TWO_SIDED|95.0|-0.52|0.33|||ANCOVA|||Change at Week 4 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.33|-0.52|0.660
73899351|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.238|TWO_SIDED|95.0|-0.54|0.14|||ANCOVA|||Change at Week 6 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.14|-0.54|0.238
73899352|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.14||0.36|TWO_SIDED|95.0|-0.42|0.16|||ANCOVA|||Change at Week 2 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.16|-0.42|0.360
73899353|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.278|TWO_SIDED|95.0|-0.16|0.54|||ANCOVA|||Change at Week 4 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.54|-0.16|0.278
73899354|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.809|TWO_SIDED|95.0|-0.34|0.27|||ANCOVA|||Change at Week 6 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.27|-0.34|0.809
73899355|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.18||0.944|TWO_SIDED|95.0|-0.35|0.38|||ANCOVA|||Change at Week 2 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.38|-0.35|0.944
73899356|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.26||0.892|TWO_SIDED|95.0|-0.48|0.55|||ANCOVA|||Change at Week 4 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.55|-0.48|0.892
73899357|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.884|TWO_SIDED|95.0|-0.39|0.45|||ANCOVA|||Change at Week 6 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.45|-0.39|0.884
73899358|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.919|TWO_SIDED|95.0|-0.26|0.28|||ANCOVA|||Change at Week 2 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.28|-0.26|0.919
73899359|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.19||0.752|TWO_SIDED|95.0|-0.33|0.45|||ANCOVA|||Change at Week 4 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.45|-0.33|0.752
73899360|NCT00545129|147330098|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.715|TWO_SIDED|95.0|-0.34|0.24|||ANCOVA|||Change at Week 6 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.24|-0.34|0.715
74084393|NCT02102932|147721995|SUPERIORITY_OR_OTHER||Ratio of the geometric means|101.38|STANDARD_DEVIATION|13.6||0|TWO_SIDED|90.0|94.82|108.39||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.39|94.82|0.0000
74088253|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.11|-0.42|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-1.11|<.0001
73960087|NCT03478696|147455800|SUPERIORITY||Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.0098||0.702|TWO_SIDED|95.0|-0.016|0.023||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.023|-0.016|0.702
73960088|NCT03478696|147455801|SUPERIORITY||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.0141||0.244|TWO_SIDED|95.0|-0.011|0.044||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.044|-0.011|0.244
73960089|NCT03615924|147455802|SUPERIORITY||Incidence rate ratio|1.06||||0.7597|TWO_SIDED|95.0|0.75|1.5|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.50|0.75|0.7597
73960090|NCT03615924|147455803|SUPERIORITY||Incidence rate ratio|1.02||||0.9037|TWO_SIDED|95.0|0.72|1.45|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.45|0.72|0.9037
73960091|NCT03615924|147455804|SUPERIORITY||Incidence rate ratio|0.76||||0.7136|TWO_SIDED|95.0|0.17|3.3|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||3.30|0.17|0.7136
73960092|NCT03615924|147455805|SUPERIORITY||Incidence rate ratio|0.84||||0.497|TWO_SIDED|95.0|0.5|1.4|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.40|0.50|0.4970
73960093|NCT03615924|147455806|SUPERIORITY||Incidence rate ratio|1.43||||0.1636|TWO_SIDED|95.0|0.87|2.36|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||2.36|0.87|0.1636
73971012|NCT02723591|147482094|SUPERIORITY|||||||0.6022|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.6022
73971013|NCT02723591|147482095|SUPERIORITY|P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||||0.9249|||||||Fisher Exact|||||||0.9249
73971014|NCT02723591|147482096|SUPERIORITY|||||||0.9136|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.9136
73971015|NCT02723591|147482097|SUPERIORITY|||||||0.8789|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.8789
73971016|NCT02723591|147482098|SUPERIORITY|||||||0.5574|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.5574
73971017|NCT02723591|147482099|SUPERIORITY|||||||0.815|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.8150
73971018|NCT02723591|147482100|SUPERIORITY|||||||0.5673|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.5673
73971019|NCT03798093|147482185|SUPERIORITY||least squares|-0.112||||0.08|TWO_SIDED|95.0|-29.3|1.7|||Regression, Linear|||||1.7|-29.3|0.08
73971020|NCT04119843|147482207|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.95|STANDARD_DEVIATION|0.824|<|0.001|TWO_SIDED|95.0|0.743|1.165|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 1||1.165|0.743|<0.001
73971021|NCT04119843|147482207|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|0.892|<|0.001|TWO_SIDED|95.0|0.552|1.043|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 2||1.043|0.552|<0.001
73971427|NCT05194956|147483625|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|9.6||||0.0213|TWO_SIDED|95.0|1.5|17.79||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||17.79|1.50|0.0213
73899361|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.47||0.666|TWO_SIDED|95.0|-0.77|1.18|||ANCOVA|||Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.18|-0.77|0.666
73899362|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.49||0.745|TWO_SIDED|95.0|-0.86|1.18|||ANCOVA|||Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.18|-0.86|0.745
73899363|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.48||0.749|TWO_SIDED|95.0|-1.14|0.83|||ANCOVA|||Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.83|-1.14|0.749
73899364|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.5||0.794|TWO_SIDED|95.0|-1.16|0.9|||ANCOVA|||Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.90|-1.16|0.794
73899365|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.56||0.772|TWO_SIDED|95.0|-1.33|1.0|||ANCOVA|||Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.33|0.772
73899366|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.5||0.547|TWO_SIDED|95.0|-0.73|1.34|||ANCOVA|||Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.34|-0.73|0.547
73899367|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.57||0.65|TWO_SIDED|95.0|-1.43|0.91|||ANCOVA|||Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.91|-1.43|0.650
73899368|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.55||0.808|TWO_SIDED|95.0|-1.27|1.0|||ANCOVA|||Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.27|0.808
73899369|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.55||0.915|TWO_SIDED|95.0|-1.19|1.07|||ANCOVA|||Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.07|-1.19|0.915
74023033|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.004
73899370|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.757|TWO_SIDED|95.0|-1.54|1.14|||ANCOVA|||Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.14|-1.54|0.757
73899371|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.57||0.987|TWO_SIDED|95.0|-1.19|1.17|||ANCOVA|||Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.17|-1.19|0.987
73899372|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.64||0.781|TWO_SIDED|95.0|-1.14|1.51|||ANCOVA|||Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.51|-1.14|0.781
74023034|NCT00190775|147598836|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
73899373|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.61||0.834|TWO_SIDED|95.0|-1.13|1.38|||ANCOVA|||Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.38|-1.13|0.834
73899374|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.59||0.851|TWO_SIDED|95.0|-1.32|1.1|||ANCOVA|||Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.10|-1.32|0.851
74023035|NCT00190775|147598837|SUPERIORITY_OR_OTHER|||||||0.546||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.546
74023036|NCT00190775|147598837|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.530
74023037|NCT00190775|147598837|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.569
74023038|NCT00190775|147598837|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||P-Vaue for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.986
73899375|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.68||0.701|TWO_SIDED|95.0|-1.68|1.15|||ANCOVA|||Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.15|-1.68|0.701
74023039|NCT00327444|147598846|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|31.8|STANDARD_ERROR_OF_MEAN|10.59||0.0019|TWO_SIDED|95.0|10.56|53.05||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).|||53.05|10.56|0.0019
74084394|NCT02102932|147721995|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.02|STANDARD_DEVIATION|16.3||0.0002|TWO_SIDED|90.0|95.08|111.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||111.63|95.08|0.0002
73847088|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.85|<0.001
73847089|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.21|||<|0.001|TWO_SIDED|95.0|1.03|1.43||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 4: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.43|1.03|<0.001
73847090|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.7|1.02||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.02|0.70|<0.001
73847091|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.83|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.20|0.83|<0.001
73847092|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.98|1.42||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 5: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.42|0.98|<0.001
73847093|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
73847094|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
73847095|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.85|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 6A: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.85|<0.001
73847096|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
73899376|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.59||0.453|TWO_SIDED|95.0|-1.68|0.77|||ANCOVA|||Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.77|-1.68|0.453
73899377|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.67||0.258|TWO_SIDED|95.0|-2.15|0.6|||ANCOVA|||Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.60|-2.15|0.258
73899378|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.64||0.736|TWO_SIDED|95.0|-1.53|1.09|||ANCOVA|||Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.09|-1.53|0.736
74023040|NCT00327444|147598847|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|375.5|STANDARD_ERROR_OF_MEAN|205.99||0.016|TWO_SIDED|95.0|-46.48|797.42||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference was estimated for aflibercept versus placebo (aflibercept-placebo).|||797.42|-46.48|0.0160
74023041|NCT00327444|147598848|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.94||0.0035|TWO_SIDED|95.0|-4.33|-0.54||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).|||-0.54|-4.33|0.0035
74023042|NCT00552110|147598853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|Analysis of Covariance (ANCOVA); classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||"Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.~Power calculation: The target randomization of 875 subjects (175 subjects per treatment arm) was needed to detect a treatment difference of 0.8 point or more in change from baseline in AM/PM NOW TNSS, with a two-sided alpha of 0.05 and 90% power, assuming a pooled standard deviation of 2.3 points."||||0.002
73899379|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.64||0.491|TWO_SIDED|95.0|-1.76|0.87|||ANCOVA|||Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.87|-1.76|0.491
73899380|NCT00545129|147330099|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.62||0.695|TWO_SIDED|95.0|-1.53|1.04|||ANCOVA|||Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.04|-1.53|0.695
73971428|NCT05194956|147483625|SUPERIORITY|Sequence effects||||||0.1583|||||||ANOVA|||||||0.1583
73971429|NCT05194956|147483625|SUPERIORITY|Period effects||||||0.4709|||||||ANOVA|||||||0.4709
73971430|NCT05194956|147483626|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|5.3||||0.0146|TWO_SIDED|95.0|1.09|9.46||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||9.46|1.09|0.0146
73971431|NCT05194956|147483626|SUPERIORITY|Sequence effects||||||0.5911|||||||ANOVA|||||||0.5911
73971432|NCT05194956|147483626|SUPERIORITY|Period effects||||||0.5825|||||||ANOVA|||||||0.5825
73971433|NCT05194956|147483627|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-5.2||||0.0817|TWO_SIDED|95.0|-11.12|0.69||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||0.69|-11.12|0.0817
73971434|NCT05194956|147483627|SUPERIORITY|Sequence effects||||||0.091|||||||ANOVA|||||||0.0910
73971435|NCT05194956|147483627|SUPERIORITY|Period effects||||||0.2278|||||||ANOVA|||||||0.2278
73971436|NCT05194956|147483628|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-2.2||||0.1347|TWO_SIDED|95.0|-5.17|0.69|||Two-period two-treatment crossover ANOVA|From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|This estimation value assumes period and sequence effects are equal between the treatments.|||0.69|-5.17|0.1347
73971437|NCT05194956|147483628|SUPERIORITY|Sequence effects||||||0.9259|||||||ANOVA|||||||0.9259
73971438|NCT05194956|147483628|SUPERIORITY|Period effects||||||0.8225|||||||ANOVA|||||||0.8225
73971439|NCT05194956|147483629|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Median Difference (Net)|-11.2||||0.02|TWO_SIDED|95.0|-20.47|-1.83||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-1.83|-20.47|0.0200
73971440|NCT05194956|147483629|SUPERIORITY|Sequence effects||||||0.9104|||||||ANOVA|||||||0.9104
73971441|NCT05194956|147483629|SUPERIORITY|Period effects||||||0.5194|||||||ANOVA|||||||0.5194
73971442|NCT05194956|147483630|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-23.2|||<|5e-05|TWO_SIDED|95.0|-30.71|-15.75||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-15.75|-30.71|<0.00005
73971443|NCT05194956|147483630|SUPERIORITY|Sequence effects||||||0.1369|||||||ANOVA|||||||0.1369
73971444|NCT05194956|147483630|SUPERIORITY|Period effects||||||0.3366|||||||ANOVA|||||||0.3366
73971445|NCT05194956|147483631|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-120.0|||<|5e-05|TWO_SIDED|95.0|-149.54|-90.38|||Two-period two-treatment crossover ANOVA|From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|This estimation value assumes period and sequence effects are equal between the treatments.|||-90.38|-149.54|<0.00005
73971446|NCT05194956|147483631|SUPERIORITY|Sequence effects||||||0.8509|||||||ANOVA|||||||0.8509
74023043|NCT00552110|147598853|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.||||<0.001
73847097|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.86|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.86|<0.001
73847098|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.9|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 6B: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.23|0.90|<0.001
73847099|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.72|0.93||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.93|0.72|<0.001
73847100|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.01||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.01|0.79|<0.001
73847101|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 7F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.96|<0.001
73847102|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.88|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.88|<0.001
73847103|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.85|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.85|<0.001
73847104|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 9V: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.11|0.84|<0.001
73847105|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.81|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.81|<0.001
73847106|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.99|1.34||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.34|0.99|<0.001
73899381|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.6||0.897|TWO_SIDED|95.0|-1.34|1.19|||ANCOVA|||Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.19|-1.34|0.897
73960094|NCT03615924|147455807|SUPERIORITY||Incidence rate ratio|1.68||||0.2011|TWO_SIDED|95.0|0.76|3.75|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||3.75|0.76|0.2011
73960095|NCT03615924|147455809|SUPERIORITY||Incidence rate ratio|0.0||||0.994|TWO_SIDED|95.0|0.0||Upper limit of confidence interval was not calculable due to 0 events in Ticagrelor 15/30/45 mg bd reporting group.||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.|||0.00|0.9940
74023044|NCT00552110|147598853|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the administration of MFNS once daily has the same mean change from baseline in AM/PM NOW TNSS as that of placebo.||||<0.001
74023045|NCT00552110|147598854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021||95.0||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|ANCOVA; classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of MFNS once daily.||||0.021
73847107|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|1.05|1.43||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 14: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.43|1.05|<0.001
73960096|NCT03615924|147455810|SUPERIORITY||Incidence rate ratio|0.77||||0.4822|TWO_SIDED|95.0|0.38|1.58|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.58|0.38|0.4822
73847108|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.96|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.26|0.96|<0.001
73847109|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.0|1.31||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.31|1.00|<0.001
73847110|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.91|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 18C: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.19|0.91|<0.001
73847111|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.79|1.02||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.02|0.79|<0.001
73847112|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.85|<0.001
73847113|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.95|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 19A: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.95|<0.001
73847114|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.81|1.05||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.05|0.81|<0.001
73847115|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.82|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.07|0.82|<0.001
73847116|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.89|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 19F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.15|0.89|<0.001
73847117|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.77|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.77|<0.001
74023046|NCT00552110|147598854|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC (0-4hr) of the change from baseline in nasal congestion score as that of MFNS once daily||||<0.001
74023047|NCT00552110|147598854|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the administration of OXY twice daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of placebo||||<0.001
74023048|NCT01511445|147598865|NON_INFERIORITY|The noninferiority margin was specified as 15 NDI points (0-100 scale).|Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.96||0.641|TWO_SIDED|95.0|-7.3|4.5|||Fisher Exact||A negative value means that the PEEK change was slightly larger than the silicon nitride study arm.|The null hypothesis was that the mean change in NDI scores from pre-op to 24 months was equal in the two study arms.||4.5|-7.3|0.641
74023049|NCT01511445|147598866|NON_INFERIORITY|The definition of fusion is rotation on flexion-extension films of less than or equal to four degrees and translation less than 1.25 mm.||||||0.71|||||||Fisher Exact|||The null hypothesis was that the fusion rates would be equal in the two study arms. The comparison includes patients with flexion-extension films at 24 months (as-treated population).||||0.710
73847118|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.87|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.87|<0.001
73847119|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.95|1.35||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 23F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.35|0.95|<0.001
73847120|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.81|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.11|0.81|<0.001
73847121|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.84|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.14|0.84|<0.001
73847122|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.88|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 22F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.21|0.88|<0.001
73847123|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.86|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.86|<0.001
73847124|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.91|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.91|<0.001
73847125|NCT03950856|147240088|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.9|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 33F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|<0.001
73847126|NCT03950856|147240089|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||Lot 1 divided by Lot 2|Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
73847127|NCT03950856|147240089|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.17|||||Lot 1 divided by Lot 3|Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.17|0.89|
73899382|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.56||0.643|TWO_SIDED|95.0|-0.9|1.43|||ANCOVA|||Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.43|-0.90|0.643
73847128|NCT03950856|147240089|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.92|1.21|||||Lot 2 divided by Lot 3|Serotype 1: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.21|0.92|
73847129|NCT03950856|147240089|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||Lot 1 divided by Lot 2|Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.95|0.77|
73847130|NCT03950856|147240089|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.91|1.13|||||Lot 1 divided by Lot 3|Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.13|0.91|
73847131|NCT03950856|147240089|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.06|1.32|||||Lot 2 divided by Lot 3|Serotype 3: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.32|1.06|
73847132|NCT03950856|147240089|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.94|||||Lot 1 divided by Lot 2|Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.94|0.72|
73847133|NCT03950856|147240089|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.94|1.23|||||Lot 1 divided by Lot 3|Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.23|0.94|
73847134|NCT03950856|147240089|OTHER||GMC Ratio|1.31|||||TWO_SIDED|95.0|1.14|1.5||||P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 4: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.50|1.14|
73847135|NCT03950856|147240089|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.95|||||Lot 1 divided by Lot 2|Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.95|0.72|
73847136|NCT03950856|147240089|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.11|||||Lot 1 divided by Lot 3|Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.84|
73847137|NCT03950856|147240089|OTHER||GMC Ratio|1.17|||||TWO_SIDED|95.0|1.02|1.35|||||Lot 2 divided by Lot 3|Serotype 5: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.35|1.02|
73960097|NCT00880048|147455832|SUPERIORITY||Mean Difference (Net)|-1.6||||0.0133|TWO_SIDED|95.0|-2.87|-0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||-0.34|-2.87|0.0133
73847138|NCT03950856|147240089|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.78|1.07|||||Lot 1 divided by Lot 2|Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.78|
73847139|NCT03950856|147240089|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16|||||Lot 1 divided by Lot 3|Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.16|0.85|
73847140|NCT03950856|147240089|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.93|1.27|||||Lot 2 divided by Lot 3|Serotype 6A: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.27|0.93|
73847141|NCT03950856|147240089|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.11|||||Lot 1 divided by Lot 2|Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.82|
73847142|NCT03950856|147240089|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.22|||||Lot 1 divided by Lot 3|Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|
73847143|NCT03950856|147240089|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.94|1.28|||||Lot 2 divided by Lot 3|Serotype 6B: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.28|0.94|
73847144|NCT03950856|147240089|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.7|0.92|||||Lot 1 divided by Lot 2|Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.92|0.70|
73847145|NCT03950856|147240089|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||Lot 1 divided by Lot 3|Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
73847146|NCT03950856|147240089|OTHER||GMC Ratio|1.2|||||TWO_SIDED|95.0|1.04|1.37|||||Lot 2 divided by Lot 3|Serotype 7F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.37|1.04|
73847147|NCT03950856|147240089|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.08|||l||Lot 1 divided by Lot 2|Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.08|0.83|
73847148|NCT03950856|147240089|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||Lot 1 divided by Lot 3|Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
73847149|NCT03950856|147240089|OTHER||GMC Ratio|1.04|||||TWO_SIDED|95.0|0.91|1.19|||||Lot 2 divided by Lot 3|Serotype 9V: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.19|0.91|
73847150|NCT03950856|147240089|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|1.0|||||Lot 1 divided by Lot 2|Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.00|0.75|
73847151|NCT03950856|147240089|OTHER||GMC Ratio|1.13|||||TWO_SIDED|95.0|0.98|1.31|||||Lot 1 divided by Lot 3|Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.31|0.98|
73847152|NCT03950856|147240089|OTHER||GMC Ratio|1.31|||||TWO_SIDED|95.0|1.14|1.52|||||Lot 2 divided by Lot 3|Serotype 14: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.52|1.14|
73847153|NCT03950856|147240089|OTHER||GMC Ratio|1.19|||||TWO_SIDED|95.0|1.04|1.36|||||Lot 1 divided by Lot 2|Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.36|1.04|
73899383|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.51||0.464|TWO_SIDED|95.0|-1.45|0.68|||ANCOVA|||Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.68|-1.45|0.464
73847154|NCT03950856|147240089|OTHER||GMC Ratio|1.32|||||TWO_SIDED|95.0|1.15|1.51|||||Lot 1 divided by Lot 3|Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.51|1.15|
73847155|NCT03950856|147240089|OTHER||GMC Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.27|||||Lot 2 divided by Lot 3|Serotype 18C: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.27|0.97|
73847156|NCT03950856|147240089|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.02|||||Lot 1 divided by Lot 2|Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.02|0.78|
73847157|NCT03950856|147240089|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.11|||||Lot 1 divided by Lot 3|Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.86|
73847158|NCT03950856|147240089|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.25|||||Lot 2 divided by Lot 3|Serotype 19A: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.25|0.96|
73847159|NCT03950856|147240089|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|1.0|||||Lot 1 divided by Lot 2|Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.00|0.76|
73847160|NCT03950856|147240089|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05|||||Lot 1 divided by Lot 3|Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.05|0.80|
73847161|NCT03950856|147240089|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.92|1.21|||||Lot 2 divided by Lot 3|Serotype 19F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.21|0.92|
73847162|NCT03950856|147240089|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.07|||||Lot 1 divided by Lot 2|Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.80|
73847163|NCT03950856|147240089|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.86|1.15|||||Lot 1 divided by Lot 3|Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.15|0.86|
73847164|NCT03950856|147240089|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.24|||||Lot 2 divided by Lot 3|Serotype 23F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.24|0.93|
73847165|NCT03950856|147240089|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.08|||||Lot 1 divided by Lot 2|Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.08|0.81|
73847166|NCT03950856|147240089|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.93|1.26|||||Lot 1 divided by Lot 3|Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.26|0.93|
73847167|NCT03950856|147240089|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|1.0|1.35|||||Lot 2 divided by Lot 3|Serotype 22F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.35|1.00|
73847168|NCT03950856|147240089|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.79|1.06|||||Lot 1 divided by Lot 2|Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.06|0.79|
73971447|NCT05194956|147483631|SUPERIORITY|Period effects||||||0.0355|||||||ANOVA|||||||0.0355
73899384|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.56||0.593|TWO_SIDED|95.0|-1.46|0.86|||ANCOVA|||Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.86|-1.46|0.593
73899385|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.61||0.423|TWO_SIDED|95.0|-1.77|0.77|||ANCOVA|||Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.77|-1.77|0.423
73899386|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.65||0.805|TWO_SIDED|95.0|-1.21|1.54|||ANCOVA|||Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.54|-1.21|0.805
73899387|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.68||0.882|TWO_SIDED|95.0|-1.3|1.51|||ANCOVA|||Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.51|-1.30|0.882
73899388|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.63||0.446|TWO_SIDED|95.0|-1.79|0.81|||ANCOVA|||Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.81|-1.79|0.446
73899389|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.68||0.604|TWO_SIDED|95.0|-1.77|1.05|||ANCOVA|||Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.05|-1.77|0.604
73899390|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.76||0.393|TWO_SIDED|95.0|-2.24|0.91|||ANCOVA|||Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.91|-2.24|0.393
73899391|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.79||0.399|TWO_SIDED|95.0|-2.33|0.97|||ANCOVA|||Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.97|-2.33|0.399
73899392|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.75||0.876|TWO_SIDED|95.0|-1.43|1.66|||ANCOVA|||Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.66|-1.43|0.876
73899393|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.66||0.74|TWO_SIDED|95.0|-1.58|1.14|||ANCOVA|||Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.14|-1.58|0.740
74023050|NCT00490542|147598891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|0.6|10.2||||||||10.2|0.6|
73899394|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.69||0.854|TWO_SIDED|95.0|-1.56|1.31|||ANCOVA|||Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.31|-1.56|0.854
73899395|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.78||0.436|TWO_SIDED|95.0|-2.24|1.0|||ANCOVA|||Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-2.24|0.436
73899396|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.72||0.087|TWO_SIDED|95.0|-2.81|0.21|||ANCOVA|||Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.21|-2.81|0.087
73899397|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.75||0.278|TWO_SIDED|95.0|-2.4|0.72|||ANCOVA|||Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.72|-2.40|0.278
74023051|NCT04696861|147598892|SUPERIORITY|||||||0.961||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.961
73899398|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.69||0.548|TWO_SIDED|95.0|-1.84|1.0|||ANCOVA|||Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.84|0.548
73960098|NCT00880048|147455832|SUPERIORITY||Mean Difference (Net)|-2.26||||0.0006|TWO_SIDED|95.0|-3.54|-0.98|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.98|-3.54|0.0006
73847169|NCT03950856|147240089|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.22|||||Lot 1 divided by Lot 3|Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|
73847170|NCT03950856|147240089|OTHER||GMC Ratio|1.15|||||TWO_SIDED|95.0|0.99|1.34|||||Lot 2 divided by Lot 3|Serotype 33F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.34|0.99|
73847171|NCT03950856|147240090|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.62|0.91|||||V114 Combined Lots divided by Prevnar 13™|Serotype 1: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|0.91|0.62|
73847172|NCT03950856|147240090|OTHER||GMC Ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||||V114 Combined Lots divided by Prevnar 13™|Serotype 3: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.61|1.20|
73847173|NCT03950856|147240090|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94|||||V114 Combined Lots divided by Prevnar 13™|Serotype 4: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|0.94|0.66|
73847174|NCT03950856|147240090|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.74|1.07|||||V114 Combined Lots divided by Prevnar 13™|Serotype 5: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.74|
73847175|NCT03950856|147240090|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|0.95|1.43|||||V114 Combined Lots divided by Prevnar 13™|Serotype 6A: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.43|0.95|
73847176|NCT03950856|147240090|OTHER||GMC Ratio|1.5|||||TWO_SIDED|95.0|1.21|1.86|||||V114 Combined Lots divided by Prevnar 13™|Serotype 6B: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.86|1.21|
73847177|NCT03950856|147240090|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04|||||V114 Combined Lots divided by Prevnar 13™|Serotype 7F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.04|0.73|
73847178|NCT03950856|147240090|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.72|1.04|||||V114 Combined Lots divided by Prevnar 13™|Serotype 9V: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.04|0.72|
73847179|NCT03950856|147240090|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.82|1.2|||||V114 Combined Lots divided by Prevnar 13™|Serotype 14: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.20|0.82|
73847180|NCT03950856|147240090|OTHER||GMC Ratio|1.26|||||TWO_SIDED|95.0|1.05|1.51|||||V114 Combined Lots divided by Prevnar 13™|Serotype 18C: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.51|1.05|
73847181|NCT03950856|147240090|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.82|1.15|||||V114 Combined Lots divided by Prevnar 13™|Serotype 19A: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.15|0.82|
73847182|NCT03950856|147240090|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.86|1.23|||||V114 Combined Lots divided by Prevnar 13™|Serotype 19F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.23|0.86|
73847183|NCT03950856|147240090|OTHER||GMC Ratio|1.26|||||TWO_SIDED|95.0|1.03|1.54|||||V114 Combined Lots divided by Prevnar 13™|Serotype 23F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.54|1.03|
73847184|NCT03950856|147240090|OTHER||GMC Ratio|12.21|||||TWO_SIDED|95.0|10.11|14.74|||||V114 Combined Lots divided by Prevnar 13™|Serotype 22F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|14.74|10.11|
73847185|NCT03950856|147240090|OTHER||GMC Ratio|9.42|||||TWO_SIDED|95.0|7.96|11.13|||||V114 Combined Lots divided by Prevnar 13™|Serotype 33F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|11.13|7.96|
73847186|NCT02121509|147240103|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.79|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|98.938|106.789|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||106.789|98.938|<0.0001
73847187|NCT02121509|147240103|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|STANDARD_ERROR_OF_MEAN|1.026|<|0.0001|TWO_SIDED|90.0|96.99|106.121|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||106.121|96.990|<0.0001
73847188|NCT02121509|147240104|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.22|STANDARD_ERROR_OF_MEAN|1.046||0.0004|TWO_SIDED|90.0|98.449|114.614|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||114.614|98.449|0.0004
73847189|NCT02121509|147240104|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.71|STANDARD_ERROR_OF_MEAN|1.051||0.004|TWO_SIDED|90.0|97.614|116.658|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||116.658|97.614|0.0040
73899399|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.75||0.318|TWO_SIDED|95.0|-2.33|0.79|||ANCOVA|||Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.79|-2.33|0.318
73899400|NCT00545129|147330100|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.73||0.484|TWO_SIDED|95.0|-2.02|0.99|||ANCOVA|||Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.99|-2.02|0.484
73899401|NCT00545129|147330101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1: P-value was calculated by Cochran-Mantel-Haenszel (CMH test) stratified by center.||||0.399
73847190|NCT02121509|147240105|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.03|STANDARD_ERROR_OF_MEAN|1.05||0.0001|TWO_SIDED|90.0|94.03|110.72|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||110.72|94.03|0.0001
73847191|NCT02121509|147240105|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|96.36|STANDARD_ERROR_OF_MEAN|1.04||0.0002|TWO_SIDED|90.0|89.96|103.22|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||103.22|89.96|0.0002
73847192|NCT02121509|147240106|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.1|STANDARD_ERROR_OF_MEAN|1.057||0.0013|TWO_SIDED|90.0|95.829|115.269|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||115.269|95.829|0.0013
73847193|NCT02121509|147240106|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|113.91|STANDARD_ERROR_OF_MEAN|1.027||0.0018|TWO_SIDED|90.0|108.749|119.318|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||119.318|108.749|0.0018
73847194|NCT02121509|147240107|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|95.748|107.487|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||107.487|95.748|<0.0001
73847195|NCT02121509|147240107|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|106.33|STANDARD_ERROR_OF_MEAN|1.034||0.0002|TWO_SIDED|90.0|100.268|112.763|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||112.763|100.268|0.0002
73847196|NCT02121509|147240108|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.07|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|90.0|94.2|110.59|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||110.59|94.20|<0.0001
73847197|NCT02121509|147240108|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.79|STANDARD_ERROR_OF_MEAN|1.04||0.0001|TWO_SIDED|90.0|90.33|103.7|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||103.70|90.33|0.0001
73899402|NCT00545129|147330101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: P-value was calculated by CMH test stratified by center.||||0.779
74088254|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.35|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.67|-1.35|<.0001
73847198|NCT04021290|147240110|NON_INFERIORITY|Non-inferiority was be concluded if the upper bound of the two-sided 95% confidence interval (CI) for the CMH adjusted difference in the proportion of patients with plasma HIV-1 RNA ≥ 50 c/mL between each treatment group (DTG/3TC - CAR) is less than 5%.|Adjusted Difference in Percent (ADP)|-0.8|||||TWO_SIDED|95.0|-2.4|0.8|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor \[PI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and integrase inhibitor \[INI\]).|||0.8|-2.4|
73847199|NCT04021290|147240111|NON_INFERIORITY|Non-inferiority will be concluded if the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms (DTG/3TC-CAR) is greater than -12%.|Adjusted Difference in Percent|1.6|||||TWO_SIDED|95.0|-2.8|5.9|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (PI, NNRTI, and INI).|||5.9|-2.8|
73899403|NCT00545129|147330101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.922|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: P-value was calculated by CMH test stratified by center.||||0.922
73899404|NCT00545129|147330101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.811|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6: P-value was calculated by CMH test stratified by center.||||0.811
73899405|NCT00545129|147330101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: P-value was calculated by CMH test stratified by center.||||0.237
73899406|NCT00545129|147330102|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.108|TWO_SIDED|95.0|-0.82|0.09|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.09|-0.82|0.108
73960099|NCT00880048|147455832|SUPERIORITY||Mean Difference (Net)|-1.57||||0.0394|TWO_SIDED|95.0|-3.06|-0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||-0.08|-3.06|0.0394
73971448|NCT01828099|147483638|SUPERIORITY||Hazard Ratio (HR)|0.55|||<|0.001|TWO_SIDED|95.0|0.42|0.73|||Log Rank|||||0.73|0.42|<0.001
73899407|NCT00545129|147330102|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.202|TWO_SIDED|95.0|-0.7|0.16|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.16|-0.70|0.202
73899408|NCT00545129|147330102|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.571|TWO_SIDED|95.0|-0.54|0.3|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.30|-0.54|0.571
73899409|NCT00545129|147330102|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.808|TWO_SIDED|95.0|-0.55|0.43|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.43|-0.55|0.808
73899410|NCT00545129|147330102|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.26||0.913|TWO_SIDED|95.0|-0.57|0.51|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.51|-0.57|0.913
73899411|NCT00545129|147330103|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.108|TWO_SIDED|95.0|-0.82|0.09|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.09|-0.82|0.108
73899412|NCT00545129|147330103|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.21||0.339|TWO_SIDED|95.0|-0.65|0.23|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.23|-0.65|0.339
73899413|NCT00545129|147330103|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.23||0.408|TWO_SIDED|95.0|-0.67|0.28|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.28|-0.67|0.408
73899414|NCT00545129|147330103|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.27||0.686|TWO_SIDED|95.0|-0.67|0.45|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.45|-0.67|0.686
73899415|NCT00545129|147330103|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.3||0.493|TWO_SIDED|95.0|-0.81|0.4|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.40|-0.81|0.493
73899416|NCT00545129|147330104|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.58||||0.724|TWO_SIDED|95.0|0.03|12.27|||Fisher Exact|||Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||12.27|0.03|0.724
73960100|NCT00880048|147455832|SUPERIORITY||Mean Difference (Net)|-1.65||||0.0332|TWO_SIDED|95.0|-3.16|-0.13|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||-0.13|-3.16|0.0332
74023052|NCT04696861|147598893|SUPERIORITY|||||||0.961||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.961
73899417|NCT00545129|147330104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.947|TWO_SIDED||||||Fisher Exact|||Week 2: P-value was calculated using Fisher Extract method.||||0.947
73899418|NCT00545129|147330104|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.634|TWO_SIDED|95.0|0.03|8.71|||Fisher Exact|||Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.71|0.03|0.634
73899419|NCT00545129|147330104|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03||||0.975|TWO_SIDED|95.0|0.14|7.74|||Fisher Exact|||Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.74|0.14|0.975
73960101|NCT00880048|147455832|SUPERIORITY||Mean Difference (Net)|-1.82||||0.0601|TWO_SIDED|95.0|-3.71|0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.08|-3.71|0.0601
73899420|NCT00545129|147330104|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.759|TWO_SIDED|95.0|0.12|18.86|||Fisher Exact|||Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||18.86|0.12|0.759
73899421|NCT00545129|147330105|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.58||||0.724|TWO_SIDED|95.0|0.03|12.27|||Fisher Exact|||Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||12.27|0.03|0.724
73899422|NCT00545129|147330105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95|TWO_SIDED||||||Fisher Exact|||Week 2: P-value was calculated using Fisher Extract test.||||0.950
73899423|NCT00545129|147330105|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.634|TWO_SIDED|95.0|0.03|8.71|||Fisher Exact|||Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.71|0.03|0.634
73899424|NCT00545129|147330105|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03||||0.975|TWO_SIDED|95.0|0.14|7.74|||Fisher Exact|||Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.74|0.14|0.975
73899425|NCT00545129|147330105|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02||||0.578|TWO_SIDED|95.0|0.17|23.89|||Fisher Exact|||Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||23.89|0.17|0.578
73899426|NCT01894568|147330118|NON_INFERIORITY_OR_EQUIVALENCE|0.4% is the margin of Non-inferiority|LS Mean Difference|-0.24||||0.005|TWO_SIDED|95.0|-0.41|-0.07|||Mixed Models Analysis|||||-0.07|-0.41|0.005
73960102|NCT00880048|147455832|SUPERIORITY||Mean Difference (Net)|-2.03||||0.0369|TWO_SIDED|95.0|-3.94|-0.12|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.12|-3.94|0.0369
73960103|NCT00880048|147455832|SUPERIORITY||Mean Difference (Net)|-1.67||||0.1122|TWO_SIDED|95.0|-3.73|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.39|-3.73|0.1122
73971449|NCT04433208|147483683|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73847200|NCT04021290|147240132|OTHER||Adjusted Mean|1.4|||<|0.001|TWO_SIDED|95.0|0.7|2.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||2.2|0.7|<0.001
73847201|NCT04021290|147240133|OTHER||Adjusted Mean|1.4|||<|0.001|TWO_SIDED|95.0|0.7|2.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||2.2|0.7|<0.001
73847202|NCT04021290|147240134|OTHER||Adjusted Mean|-1.6||||0.021|TWO_SIDED|95.0|-2.9|-0.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||-0.2|-2.9|0.021
73847203|NCT04021290|147240135|OTHER||Adjusted Mean|-0.5||||0.398|TWO_SIDED|95.0|-1.8|0.7|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||0.7|-1.8|0.398
73847204|NCT00636181|147240137|SUPERIORITY|||||||0.3||||||PSG outcomes employed analysis of variance for approximately normally distributed outcomes (or outcomes that could be transformed to an approximately normal distribution), and the Kruskal-Wallis test for non-normal outcomes.|Kruskal-Wallis|Pairwise differences were determined using Tukey-Kramer test- ANOVA applied or by Mann-Whitney-Wilcoxon summed rank tests and Bonferroni adjustment.||||||0.3
73847205|NCT05076045|147240169|SUPERIORITY|||||||0.03||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Results of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in percentage of correct answers between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||0.03
73847206|NCT05076045|147240170|SUPERIORITY|||||||0.28||||||The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|||Null hypothesis is that there was no difference in reaction time between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio as within-subject factors. Participants were included as a random factor.||||0.28
73847207|NCT05076045|147240171|SUPERIORITY|||||||0.005||||||The threshold for statistical significance was p = 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in Quick Speech In Noise score between PSAPs and Control. The performance of the QuickSIN for the two sessions (PSAPs, Control) was compared using the Wilcoxon signed rank test on paired samples.||||0.005
73847208|NCT05076045|147240172|SUPERIORITY|||||||1||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||1.00
73847209|NCT05076045|147240173|SUPERIORITY|This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).||||||1|||||||Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||1.00
73847210|NCT05076045|147240174|SUPERIORITY|||||||0.36||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||0.36
73847211|NCT05076045|147240175|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05 (two-sided).|Cumulative link mixed model|||Null hypothesis is that there was no difference in listening effort between PSAPs and Control. The listening effort score was analyzed using a cumulative link mixed model. A logit link function with flexible thresholds was used. The model included Session (PSAPs, Control) and Block (1, 2, 3) as within-subject factors. Participants were included as a random factor.||||<0.001
73847212|NCT01174563|147240189|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.005|TWO_SIDED|95.0|0.41|0.83|||Log Rank|||||0.83|0.41|0.005
73847213|NCT01347060|147240200|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.0051|TWO_SIDED|95.0|0.68|0.93||The P-value relates to differences in combined inpatient/emergency department.|Regression, Cox|Adjusted for baseline differences||||0.93|0.68|0.0051
73847214|NCT01347060|147240201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|883.23||||0.001|TWO_SIDED|95.0|731.66|1041.69||The P-value is on the adjusted difference in total asthma costs.|Regression, Linear|Generalized Linear Model with a log-link and a gamma distribution adjusting for differences at baseline||||1041.69|731.66|0.001
74023053|NCT04696861|147598894|SUPERIORITY|||||||0.368||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.368
73847215|NCT01347060|147240202|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73899427|NCT04545944|147330137|OTHER||Geometric Least Squares Mean Ratio|192.4|||||TWO_SIDED|90.0|152.8|242.4||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||242.4|152.8|
73899428|NCT04545944|147330138|OTHER||Geometric Least Squares Mean Ratio|188.9|||||TWO_SIDED|90.0|150.6|236.9||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||236.9|150.6|
73899429|NCT04545944|147330139|OTHER||Geometric Least Squares Mean Ratio|193.4|||||TWO_SIDED|90.0|160.5|233.1||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||233.1|160.5|
73899430|NCT01514370|147330145|OTHER|||||||0.271|||||||Chi-squared|||||||0.271
73899431|NCT01551420|147330166|SUPERIORITY|Null hypothesis of no change after home use|Mean Difference (Net)|0.002|STANDARD_DEVIATION|0.68||0.9358|TWO_SIDED|95.0|-0.27|0.28||Two way comparison between scores at baseline and after 9-12 weeks of Prosthetic use. Alpha=0.05|t-test, 2 sided|paired t-tests||||0.28|-0.27|.9358
73899432|NCT01551420|147330166|SUPERIORITY||Slope|-0.69||||0.08|TWO_SIDED|95.0|-1.47|0.09|||Regression, Linear|||Linear regression of QOL measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.09|-1.47|0.08
73899433|NCT01551420|147330167|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.42|<|0.0001|TWO_SIDED|95.0|0.17|0.43|||t-test, 2 sided|The sample for this analyses was 44 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with UEFS data at both time points).||0.43|0.17|<0.0001
73899434|NCT01551420|147330167|SUPERIORITY||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.73|-0.4|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS use measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.40|-0.73|<0.0001
73899435|NCT01551420|147330168|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_DEVIATION|0.94||0.186|TWO_SIDED|95.0|-0.55|0.11|||t-test, 2 sided|The sample for this analysis was 34 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with TAPES data at both time points).||0.11|-0.55|0.186
73899436|NCT01551420|147330168|SUPERIORITY||Slope|-1.15|STANDARD_ERROR_OF_MEAN|0.44||0.0168|TWO_SIDED|95.0|-2.06|-0.23|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for TAPES at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from TAPES measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.23|-2.06|0.0168
73960104|NCT00880048|147455832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.4713|TWO_SIDED|95.0|-2.85|1.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||1.32|-2.85|0.4713
73960105|NCT00880048|147455833|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2232|TWO_SIDED|95.0|0.63|7.39|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1||7.39|0.63|0.2232
73960106|NCT00880048|147455833|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0559|TWO_SIDED|95.0|0.97|10.2|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1||10.2|0.97|0.0559
73960107|NCT00880048|147455833|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3395|TWO_SIDED|95.0|0.64|3.61|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2||3.61|0.64|0.3395
73899437|NCT01551420|147330169|SUPERIORITY||Mean Difference (Net)|-0.97|STANDARD_DEVIATION|5.61||0.3367|TWO_SIDED|95.0|-2.99|1.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).||1.05|-2.99|0.3367
73899438|NCT01551420|147330169|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|1.49||0.6339|TWO_SIDED|95.0|-3.84|2.39|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from AM-ULA measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||2.39|-3.84|0.6339
73960108|NCT00880048|147455833|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4256|TWO_SIDED|95.0|0.59|3.5|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2||3.50|0.59|0.4256
73960109|NCT00880048|147455833|SUPERIORITY||Odds Ratio (OR)|1.35||||0.379|TWO_SIDED|95.0|0.69|2.64|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4||2.64|0.69|0.3790
73960110|NCT00880048|147455833|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2554|TWO_SIDED|95.0|0.76|2.86|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4||2.86|0.76|0.2554
73960111|NCT00880048|147455833|SUPERIORITY||Odds Ratio (OR)|1.53||||0.1961|TWO_SIDED|95.0|0.8|2.91|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6||2.91|0.80|0.1961
73960112|NCT00880048|147455833|SUPERIORITY||Odds Ratio (OR)|1.15||||0.6916|TWO_SIDED|95.0|0.58|2.25|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6||2.25|0.58|0.6916
74023054|NCT04696861|147598896|SUPERIORITY|||||||0.634||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.634
73960113|NCT00880048|147455834|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.61|TWO_SIDED|95.0|0.5|1.95|||Log Rank|||||1.95|0.50|0.61
73960114|NCT00880048|147455834|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.35|TWO_SIDED|95.0|0.36|1.54|||Log Rank|||||1.54|0.36|0.35
73960115|NCT00880048|147455835|SUPERIORITY||Mean Difference (Net)|-0.69||||0.0362|TWO_SIDED|95.0|-1.34|-0.04|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||-0.04|-1.34|0.0362
73960116|NCT00880048|147455835|SUPERIORITY||Mean Difference (Net)|-0.81||||0.0155|TWO_SIDED|95.0|-1.46|-0.16|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.16|-1.46|0.0155
73960117|NCT00880048|147455835|SUPERIORITY||Mean Difference (Net)|-0.46||||0.2593|TWO_SIDED|95.0|-1.27|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.34|-1.27|0.2593
73847216|NCT01542788|147240209|SUPERIORITY_OR_OTHER||Proportion difference|77.3|||<|0.001|TWO_SIDED|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by presence or absence of cirrhosis for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 180 subjects in the active group and 60 in the placebo group would provide 99% power to detect a difference between group SVR12 rates of 40% using a 2-sided continuity-corrected chi-square test at significance level of 0.05.||83.6|71.0|< 0.001
73847217|NCT01542788|147240211|SUPERIORITY_OR_OTHER||Proportion difference|82.7|||||TWO_SIDED|95.0|76.8|88.5|||||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||88.5|76.8|
73847218|NCT01542788|147240212|SUPERIORITY_OR_OTHER||Proportion difference|77.3|||<|0.001|TWO_SIDED|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by randomization stratification factor for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||83.6|71.0|< 0.001
73847219|NCT00269113|147240217|SUPERIORITY_OR_OTHER||Difference in percentage of participants|17.4||||0.0009|TWO_SIDED|95.0|6.4|28.4|||Fisher Exact|||||28.4|6.4|0.0009
73847220|NCT00269113|147240218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73847221|NCT00269113|147240219|SUPERIORITY_OR_OTHER|||||||0.0127|||||||Log Rank|||||||0.0127
73847222|NCT00269113|147240220|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73847223|NCT00269113|147240221|SUPERIORITY_OR_OTHER|||||||0.0186|||||||Log Rank|||||||0.0186
73847224|NCT00269113|147240222|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Log Rank|||||||0.0002
73847225|NCT00269113|147240223|SUPERIORITY_OR_OTHER|||||||0.0017|||||||Log Rank|||||||0.0017
73899439|NCT01551420|147330170|SUPERIORITY||Mean Difference (Net)|-1.74|STANDARD_DEVIATION|18.8||0.5465|TWO_SIDED|95.0|-7.53|4.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with SF-36V Role Physical data at both time points).||4.05|-7.53|0.5465
73899440|NCT01551420|147330170|SUPERIORITY||Mean Difference (Net)|-3.78|STANDARD_DEVIATION|17.37||0.161|TWO_SIDED|95.0|-9.12|1.57|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Social Functioning data at both time points).||1.57|-9.12|0.1610
73899441|NCT01551420|147330170|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_DEVIATION|13.9||0.7765|TWO_SIDED|95.0|-4.9|3.68|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Physical Functioning data at both time points).||3.68|-4.90|0.7765
73899442|NCT01551420|147330170|SUPERIORITY||Slope|-13.35|STANDARD_ERROR_OF_MEAN|6.91||0.0669|TWO_SIDED|95.0|-27.72|1.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V; Role Physical measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.02|-27.72|0.0669
74023055|NCT04696861|147598897|SUPERIORITY|||||||0.832||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.832
73847226|NCT02026011|147240231|SUPERIORITY_OR_OTHER|||||||0.39||||||Medication effect: b = -0.15, SE = 0.17, t = -0.86, p = 0.39|Mixed Models Analysis|||||||0.39
73847227|NCT02026011|147240231|SUPERIORITY_OR_OTHER|||||||0.34||||||Genotype effect: b = 0.20, SE = 0.21, t = 0.96, p = 0.34|Mixed Models Analysis|||||||0.34
73847228|NCT02026011|147240231|SUPERIORITY_OR_OTHER|||||||0.04||||||BrAC effect: b = 0.13, SE = 0.06, t = 2.10, p = 0.04|Mixed Models Analysis|||||||0.04
73847229|NCT02026011|147240231|SUPERIORITY_OR_OTHER|||||||0.47||||||Medication by genotype interaction: b = 0.15, SE = 0.21, t = 0.73, p = 0.47|Mixed Models Analysis|||||||0.47
73847230|NCT02026011|147240231|SUPERIORITY_OR_OTHER|||||||0.13||||||Medication by genotype by BrAC interaction: b = -0.20, SE = 0.13, t = -1.52, p = 0.13|Mixed Models Analysis|||||||0.13
73847231|NCT02026011|147240232|SUPERIORITY_OR_OTHER|||||||0.23||||||Medication effect: b = 0.16, SE = 0.13, t = 1.20, p = 0.23|Mixed Models Analysis|||||||0.23
73847232|NCT02026011|147240232|SUPERIORITY_OR_OTHER|||||||0.09||||||Genotype effect: b = 0.37, SE = 0.22, t = 1.69, p = 0.09|Mixed Models Analysis|||||||0.09
73847233|NCT02026011|147240232|SUPERIORITY_OR_OTHER|||||||0.84||||||Medication by genotype interaction: b = 0.04, SE = 0.21, t = 0.20, p = 0.84|Mixed Models Analysis|||||||0.84
73847234|NCT02026011|147240232|SUPERIORITY_OR_OTHER|||||||0.05||||||Medication by genotype by BrAC interaction: b = -0.32, SE = 0.16, t = -1.93, p = 0.05|Mixed Models Analysis|||||||0.05
73847235|NCT02026011|147240233|SUPERIORITY_OR_OTHER|||||||0.55||||||Medication effect: b = 0.14, SE = 0.23, t = 0.61, p = 0.55|Mixed Models Analysis|||||||0.55
73847236|NCT02026011|147240233|SUPERIORITY_OR_OTHER|||||||0.77||||||Genotype effect: b = -0.11, SE = 0.37, t = -0.30, p = 0.77|Mixed Models Analysis|||||||0.77
73847237|NCT02026011|147240233|SUPERIORITY_OR_OTHER|||||||0.04||||||BrAC effect: b = 0.30, SE = 0.15, t = 2.02, p = 0.04|Mixed Models Analysis|||||||0.04
73847238|NCT02026011|147240233|SUPERIORITY_OR_OTHER|||||||0.47||||||Medication by genotype interaction: b = -0.21, SE = 0.29, t = -0.72, p = 0.47|Mixed Models Analysis|||||||0.47
73847239|NCT02026011|147240233|SUPERIORITY_OR_OTHER|||||||0.19||||||Medication by genotype by BrAC interaction: b = 0.28, SE = 0.21, t = 1.30, p = 0.19|Mixed Models Analysis|||||||0.19
73847240|NCT02026011|147240235|SUPERIORITY_OR_OTHER|||||||0.14||||||Medication effect: F(1,71) = 2.24, p = 0.14|Poisson Regression|||||||0.14
73847241|NCT02026011|147240235|SUPERIORITY_OR_OTHER|||||||0.02||||||Genotype effect: F(1, 71) = 5.79, p = 0.02|Poisson|||||||0.02
73847242|NCT02026011|147240235|SUPERIORITY_OR_OTHER|||||||0.41||||||Medication by genotype interaction: F(1, 70) = 0.68, p = 0.41.|Poisson|||||||0.41
73960118|NCT00880048|147455835|SUPERIORITY||Mean Difference (Net)|-0.62||||0.1407|TWO_SIDED|95.0|-1.44|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.20|-1.44|0.1407
73847243|NCT00755807|147240245|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM):Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\*Week+Baseline\*Week,participant random effect.||Null hypothesis: no difference between duloxetine and placebo on pain severity reduction as measured by weekly mean of the daily 24-hour average pain scores in participants assessed at 6 weeks. Sample size is determined using 2-sided t-test with significance level of 0.05, and 5% of randomized participants without post-baseline data due to very early discontinuation. With 119 participants per arm, study has approximately 80% power to detect an effect size of 0.375 on treatment group difference.||||0.001
73847244|NCT00755807|147240246|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for the 30% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.027
73847245|NCT00755807|147240246|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-value is for 50% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.246
73847246|NCT00755807|147240246|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value is for the 30% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.024
73847247|NCT00755807|147240246|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for 50% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.165
73847248|NCT00755807|147240247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.121|TWO_SIDED|95.0|-0.06|0.49||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Analysis of Variance (ANOVA) Model: PGI improvement at Endpoint = Treatment + Investigator.|The mean difference is for placebo - duloxetine.|||0.49|-0.06|0.121
73847249|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.016|TWO_SIDED|95.0|0.12|1.2||P-value is for BPI Severity for Worst Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.20|0.12|0.016
73847250|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.043|TWO_SIDED|95.0|0.02|0.95||P-value is for BPI Severity for Least Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.95|0.02|0.043
73899443|NCT01551420|147330170|SUPERIORITY||Slope|-8.24|STANDARD_ERROR_OF_MEAN|7.1||0.2592|TWO_SIDED|95.0|-23.01|6.54|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Social Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||6.54|-23.01|0.2592
73847251|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.03|TWO_SIDED|95.0|0.05|0.99||P-value is for BPI Severity for Average Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.99|0.05|0.030
73847252|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.001|TWO_SIDED|95.0|0.36|1.43||P-value is for BPI Severity for Pain Right Now score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.43|0.36|0.001
73847253|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.083|TWO_SIDED|95.0|-0.07|1.11||P-value is for BPI Interference for General Activity score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.11|-0.07|0.083
73847254|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.034|TWO_SIDED|95.0|0.05|1.27||P-value is for BPI Interference for Mood score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.27|0.05|0.034
73847255|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.089|TWO_SIDED|95.0|-0.08|1.19||P-value is for BPI Interference for Walking Ability score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.19|-0.08|0.089
73847256|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.291|TWO_SIDED|95.0|-0.28|0.93||P-value is for BPI Interference for Normal Work score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.93|-0.28|0.291
73847257|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.077|TWO_SIDED|95.0|-0.06|1.05||P-value is for BPI Interference for Relations With Others score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.05|-0.06|0.077
73960119|NCT00880048|147455835|SUPERIORITY||Mean Difference (Net)|-0.67||||0.1933|TWO_SIDED|95.0|-1.67|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.34|-1.67|0.1933
73847258|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.148|TWO_SIDED|95.0|-0.15|0.97||P-value is for BPI Interference for Sleep score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.97|-0.15|0.148
74023056|NCT04696861|147598899|SUPERIORITY|||||||0.624||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.624
74023057|NCT04696861|147598900|SUPERIORITY|||||||0.833||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.833
74023058|NCT04696861|147598901|SUPERIORITY|||||||0.7||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.7
74023059|NCT04696861|147598902|SUPERIORITY|||||||0.79||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.79
74023060|NCT04696861|147598903|SUPERIORITY|||||||0.55||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.55
74023061|NCT04696861|147598904|SUPERIORITY|||||||0.823|||||||Mixed Models Analysis|||||||.823
74023062|NCT04696861|147598905|SUPERIORITY|||||||0.942|||||||Mixed Models Analysis|||||||.942
74023063|NCT04696861|147598906|SUPERIORITY|||||||0.207||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.207
74023064|NCT04696861|147598907|SUPERIORITY|||||||0.594||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.594
74023065|NCT04696861|147598908|SUPERIORITY|||||||0.738||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.738
74023066|NCT04696861|147598909|SUPERIORITY|||||||0.845||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.845
74023067|NCT00666562|147598939|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED||||||t-test, 2 sided|||||||0.046
74023068|NCT01587989|147598954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.327||||0.188|TWO_SIDED|95.0|-0.165|0.82|||t-test, 2 sided|||||0.820|-0.165|0.188
74023069|NCT01587989|147598954|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||ANCOVA|||At Week 12.||||0.015
74023070|NCT01587989|147598954|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED||||||ANCOVA|||Adjusted change in DAS28 score from Weeks 12-24.||||0.304
74023071|NCT01587989|147598955|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED||||||Fisher Exact|||||||0.732
74023072|NCT01587989|147598956|SUPERIORITY_OR_OTHER|||||||0.207|TWO_SIDED||||||Fisher Exact|||||||0.207
74023073|NCT01587989|147598957|SUPERIORITY_OR_OTHER|||||||0.453|TWO_SIDED||||||Fisher Exact|||||||0.453
74023074|NCT01587989|147598958|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||Fisher Exact|||||||0.084
74023075|NCT01587989|147598959|SUPERIORITY_OR_OTHER|||||||0.842|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.842
74084395|NCT02102932|147721996|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.91|STANDARD_DEVIATION|11.2||0|TWO_SIDED|90.0|99.29|110.86||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||110.86|99.29|0.0000
74023076|NCT01587989|147598960|SUPERIORITY_OR_OTHER|||||||0.417|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Physical standardized value||||0.417
74023077|NCT01587989|147598960|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mental standardized value||||0.112
74023078|NCT01587989|147598961|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Fatigue||||0.655
74023079|NCT01587989|147598961|SUPERIORITY_OR_OTHER|||||||0.839|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Pain||||0.839
74023080|NCT01587989|147598962|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Effectiveness||||0.580
74023081|NCT01587989|147598962|SUPERIORITY_OR_OTHER|||||||0.975|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Side-effects||||0.975
74023082|NCT01587989|147598962|SUPERIORITY_OR_OTHER|||||||0.421|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Convenience||||0.421
74023083|NCT01587989|147598962|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Global satisfaction||||0.277
74023084|NCT03128957|147598965|EQUIVALENCE|Given the small sample permutation are feasible.||||||0.036|||||||permutation test|Given the non-parametric nature of spearman's correlation coefficient and a small sample we used a permutation test to calculate p-values.||Non-parametric covariance adjusted Spearman's correlation ρ\_s. To test the Null that Ho: ρ\_s.=0 vs alternative that Ha: ρ\_s.≠0, we used a method that calculates the probability that it would be greater than or equal to the observed ρ ̂, given the null hypothesis, by using a permutation test. An advantage of this approach is that it automatically takes into account the number of tied data values in the sample and the way they are treated in computing the rank correlation.||||0.036
74023085|NCT03128957|147598966|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)||||0.015
74023086|NCT03128957|147598967|SUPERIORITY|||||||0.047|||||||Kruskal-Wallis|||Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)||||0.047
74023087|NCT00684177|147598968|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.4||||0.098|TWO_SIDED|95.0|-1.6|18.4|||Chi-squared|||||18.4|-1.6|0.098
74023088|NCT00684177|147598969|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.04|TWO_SIDED|95.0|0.6|23.6|||Chi-squared|||||23.6|0.6|0.04
74023089|NCT00684177|147598970|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.04|TWO_SIDED|95.0|0.6|23.6|||Chi-squared|||||23.6|0.6|0.04
74023090|NCT03797001|147598984|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
73847259|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.582|TWO_SIDED|95.0|-0.45|0.79||P-value is for BPI Interference for Enjoyment Of Life score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.79|-0.45|0.582
73847260|NCT00755807|147240248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.067|TWO_SIDED|95.0|-0.03|0.94||P-value is for BPI Mean Interference score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.94|-0.03|0.067
73847261|NCT00755807|147240249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.041|TWO_SIDED|95.0|0.01|0.45||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.45|0.01|0.041
73847262|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.5|TWO_SIDED|95.0|-3.9|1.91||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.91|-3.90|0.500
73847263|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.512|TWO_SIDED|95.0|-4.87|2.44||P-value is for treatment comparison of change from baseline on MSQOL Mental Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.44|-4.87|0.512
73847264|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.72|TWO_SIDED|95.0|-4.51|3.12||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||3.12|-4.51|0.720
73899444|NCT01551420|147330170|SUPERIORITY||Slope|-30.23|STANDARD_ERROR_OF_MEAN|6.25|<|0.0001|TWO_SIDED|95.0|-43.23|-17.23|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Physical Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-17.23|-43.23|<0.0001
73899445|NCT01551420|147330171|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.17||0.6691|TWO_SIDED|95.0|-0.05|0.07|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Writing data at both time points).||0.07|-0.05|0.6691
73899446|NCT01551420|147330171|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.06||0.0511|TWO_SIDED|95.0|-0.05|0.0|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Page turning data at both time points).||0.00|-0.05|0.0511
74023091|NCT00215150|147599045|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Wilcoxon Signed Rank Test|||Results are from a Wilcoxon signed rank test on the difference from endpoint to baseline for the intent to treat sample from the open label phase of the project.||||< 0.001
74023092|NCT00215150|147599045|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||Results are from a Kruskal Wallis test on the ziprasidone/placebo groups from the randomization phase of the project.||||> .05
74023093|NCT00318292|147599102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.003||95.0|-3.2|-0.7|||t-test, 2 sided|||||-0.7|-3.2|.003
74023094|NCT00824564|147599117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.5|STANDARD_ERROR_OF_MEAN|58.63||0.348|TWO_SIDED|95.0|-172.7|61.7|||t-test, 2 sided|||The mean difference with associated standard error (SE), and corresponding 95% confidence interval (CI) for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||61.7|-172.7|0.348
74023095|NCT00824564|147599118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.0|STANDARD_ERROR_OF_MEAN|32.78||0.466|TWO_SIDED|95.0|-41.3|89.3|||t-test, 2 sided|||The mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||89.3|-41.3|0.466
74023096|NCT00824564|147599119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|5.57||0.109|TWO_SIDED|95.0|-20.7|2.2|||t-test, 2 sided|||For 1 hour post-surgery, the mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||2.2|-20.7|0.109
73847265|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.973|TWO_SIDED|95.0|-3.58|3.46||P-value is for treatment comparison of change from baseline on MSQOL Health Perceptions Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||3.46|-3.58|0.973
73847266|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.991|TWO_SIDED|95.0|-4.07|4.02||P-value is for treatment comparison of change from baseline on MSQOL Energy Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.02|-4.07|0.991
73847267|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.14||||0.441|TWO_SIDED|95.0|-11.14|4.87||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Physical Problems Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.87|-11.14|0.441
73847268|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.108|TWO_SIDED|95.0|-7.94|0.79||P-value is for treatment comparison of change from baseline on MSQOL Pain Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.79|-7.94|0.108
73847269|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.948|TWO_SIDED|95.0|-5.77|5.39||P-value is for treatment comparison of change from baseline on MSQOL Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||5.39|-5.77|0.948
73847270|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.96||||0.374|TWO_SIDED|95.0|-2.37|6.28||P-value is for treatment comparison of change from baseline on MSQOL Social Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||6.28|-2.37|0.374
73847271|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.867|TWO_SIDED|95.0|-4.1|4.87||P-value is for treatment comparison of change from baseline on MSQOL Health Distress Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.87|-4.10|0.867
73847272|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77||||0.306|TWO_SIDED|95.0|-1.63|5.17||P-value is for treatment comparison of change from baseline on MSQOL Overall Quality Of Life Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||5.17|-1.63|0.306
73847273|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.733|TWO_SIDED|95.0|-4.08|2.88||P-value is for treatment comparison of change from baseline on MSQOL Emotional Well-being Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.88|-4.08|0.733
73847274|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.283|TWO_SIDED|95.0|-13.88|4.08||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Emotional Problems score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.08|-13.88|0.283
73847275|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.664|TWO_SIDED|95.0|-4.49|2.86||P-value is for treatment comparison of change from baseline on MSQOL Cognitive Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.86|-4.49|0.664
73847276|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98||||0.504|TWO_SIDED|95.0|-7.81|3.85||P-value is for treatment comparison of change from baseline on MSQOL Change in Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine|||3.85|-7.81|0.504
73960120|NCT00880048|147455835|SUPERIORITY||Mean Difference (Net)|-0.74||||0.15|TWO_SIDED|95.0|-1.76|0.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||0.27|-1.76|0.1500
73847277|NCT00755807|147240250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02||||0.27|TWO_SIDED|95.0|-11.18|3.14||P-value is for treatment comparison of change from baseline on MSQOL Satisfaction with Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine|||3.14|-11.18|0.270
73847278|NCT00755807|147240251|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Ideation during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.119
73847279|NCT00755807|147240251|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Behavior during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.494
73847280|NCT00755807|147240251|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Acts during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.494
73960121|NCT00880048|147455835|SUPERIORITY||Mean Difference (Net)|-1.09||||0.055|TWO_SIDED|95.0|-2.21|0.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.02|-2.21|0.0550
73960122|NCT00880048|147455835|SUPERIORITY||Mean Difference (Net)|-0.52||||0.3627|TWO_SIDED|95.0|-1.65|0.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.61|-1.65|0.3627
74023097|NCT00824564|147599119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.24||0.045|TWO_SIDED|95.0|-13.4|-0.1|||t-test, 2 sided|||For 4 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||-0.1|-13.4|0.045
73847281|NCT00755807|147240252|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures model:Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\*Week+Baseline\*Week; participant=random effect.||||||0.002
73847282|NCT00755807|147240253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.662|TWO_SIDED|95.0|-0.06|0.04||P-value is for treatment comparison of change from baseline on BDI-II Question #9 score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.04|-0.06|0.662
73847283|NCT00755807|147240254|SUPERIORITY_OR_OTHER|||||||0.244||95.0||||This is the P-value for Discontinuation Due to Any Reason.|Fisher Exact|||||||0.244
73847284|NCT00755807|147240254|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||This is the P-value for Adverse Event (AE).|Fisher Exact|||||||0.012
73847285|NCT00755807|147240254|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||This is the P-value for Protocol Violation.|Fisher Exact|||||||0.622
73847286|NCT00755807|147240254|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Subject Decision.|Fisher Exact|||||||1.00
73847287|NCT00755807|147240254|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Lack of Efficacy.|Fisher Exact|||||||1.00
73847288|NCT00755807|147240254|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Physician Decision.|Fisher Exact|||||||1.00
73847289|NCT00755807|147240257|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for treatment comparison of change from baseline on Bicarbonate, HCO3. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.047
73847290|NCT00755807|147240258|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value is for treatment comparison of change from baseline on creatinine. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.033
73899447|NCT01551420|147330171|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.09||0.5942|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Lifting Small Items data at both time points).||0.04|-0.02|0.5942
74023098|NCT00824564|147599119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|4.2||0.119|TWO_SIDED|95.0|-15.4|1.8|||t-test, 2 sided|||For 8 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||1.8|-15.4|0.119
73847291|NCT00755807|147240259|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for treatment comparison of change from baseline on platelet count. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from baseline = Treatment + Investigator.||||||0.034
73847292|NCT00755807|147240260|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value is for treatment comparison of change from baseline on inorganic phosphorus. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.007
73847293|NCT00755807|147240261|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for treatment comparison of change from baseline on uric acid. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.025
73847294|NCT00755807|147240262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.322|TWO_SIDED|95.0|-2.55|0.84||P-value is for treatment comparison of change from baseline on diastolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.84|-2.55|0.322
73847295|NCT00755807|147240262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.787|TWO_SIDED|95.0|-3.32|2.52||P-value is for treatment comparison of change from baseline on systolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.52|-3.32|0.787
73847296|NCT00755807|147240263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.16|TWO_SIDED|95.0|-3.7|0.61||P-value is for treatment comparison of change from baseline on pulse rate. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.61|-3.70|0.160
73847297|NCT00755807|147240264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.003|TWO_SIDED|95.0|0.27|1.26||P-value is for treatment comparison of change from baseline on weight. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.26|0.27|0.003
73847298|NCT00755807|147240265|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean PGI-I score at 18 weeks for all participants who entered extension phase.||||||<0.001
73847299|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Worst Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Worst Pain.||||||<0.001
73847300|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Least Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Least Pain score.||||||<0.001
73847301|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Average Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Average Pain score.||||||<0.001
73847302|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Pain Right Now score.||||||<0.001
73847303|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-I for General Activity. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for General Activity score.||||||<0.001
73847304|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Mood. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Mood score.||||||<0.001
73847305|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Walking Ability. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Walking Ability score.||||||<0.001
73847306|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Normal Work. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Normal Work score.||||||<0.001
73847307|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Relations With Others. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from baseline to endpoint on BPI-I for Relations With Others score.||||||<0.001
73960123|NCT00880048|147455836|SUPERIORITY||Mean Difference (Net)|-1.03||||0.0616|TWO_SIDED|95.0|-2.11|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.05|-2.11|0.0616
73847308|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Sleep. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Sleep score.||||||<0.001
73847309|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Enjoyment of Life. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Enjoyment Of Life score.||||||<0.001
73847310|NCT00755807|147240266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI for Mean Interference Score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI for Mean Interference score.||||||<0.001
73847311|NCT00755807|147240267|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on CGI-S score for all participants who entered extension phase.||||||<0.001
73847312|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Composite Section score.||||||0.002
73847313|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Mental Health Composite Section score.||||||0.054
73847314|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Subsection score.||||||0.002
73847315|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Perceptions Subsection score.||||||0.025
73847316|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Energy Subsection score.||||||0.008
73847317|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.858||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Physical Problems Subsection score.||||||0.858
73960124|NCT00880048|147455836|SUPERIORITY||Mean Difference (Net)|-2.28|||<|0.0001|TWO_SIDED|95.0|-3.36|-1.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-1.19|-3.36|<0.0001
73847318|NCT00755807|147240268|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Pain Subsection score.||||||<0.001
73847319|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Sexual Function Subsection score.||||||0.637
73899448|NCT01551420|147330171|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.08||0.0101|TWO_SIDED|95.0|-0.07|-0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Checkers data at both time points).||-0.01|-0.07|0.0101
73899449|NCT01551420|147330171|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.09||0.1063|TWO_SIDED|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Feeding data at both time points).||0.01|-0.06|0.1063
73899450|NCT01551420|147330171|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.12||0.2474|TWO_SIDED|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Light Cans data at both time points).||0.01|-0.06|0.2474
73899451|NCT01551420|147330171|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_DEVIATION|0.14||0.1604|TWO_SIDED|95.0|-0.09|0.02|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Heavy Cans data at both time points).||0.02|-0.09|0.1604
73899452|NCT01551420|147330171|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.4208|TWO_SIDED|95.0|-0.12|0.09|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Writing measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.09|-0.12|0.4208
73899453|NCT01551420|147330171|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.1959|TWO_SIDED|95.0|-0.09|0.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Page Turning measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.02|-0.09|0.1959
73899454|NCT01551420|147330171|SUPERIORITY|Linear regression of scores from JTHFT: Lifting Small Items measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3328|TWO_SIDED|95.0|-0.09|0.03|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|||0.03|-0.09|0.3328
73847320|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Social Function Subsection score.||||||0.051
73899455|NCT01551420|147330171|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6585|TWO_SIDED|95.0|-0.05|0.08|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Checkers measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.08|-0.05|0.6585
73899456|NCT01551420|147330171|SUPERIORITY|Linear regression of scores from JTHFT: Feeding measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0552|TWO_SIDED|95.0|-0.12|0.0|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|||0.00|-0.12|0.0552
73899457|NCT01551420|147330171|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0319|TWO_SIDED|95.0|-0.25|-0.01|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Light Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.01|-0.25|0.0319
73899458|NCT01551420|147330171|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0073|TWO_SIDED|95.0|-0.24|-0.04|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Heavy Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.04|-0.24|0.0073
73847321|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Distress Subsection score.||||||0.270
73960125|NCT00880048|147455836|SUPERIORITY||Mean Difference (Net)|-1.44||||0.0239|TWO_SIDED|95.0|-2.68|-0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||-0.19|-2.68|0.0239
73960126|NCT00880048|147455836|SUPERIORITY||Mean Difference (Net)|-1.84||||0.0048|TWO_SIDED|95.0|-3.12|-0.57|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||-0.57|-3.12|0.0048
73899459|NCT01551420|147330172|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_DEVIATION|0.52||0.6529|TWO_SIDED|95.0|-0.24|0.15|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Spontaneity data at both time points).||0.15|-0.24|0.6529
73899460|NCT01551420|147330172|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.64||0.849|TWO_SIDED|95.0|-0.26|0.22|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Skill data at both time points).||0.22|-0.26|0.8490
73899461|NCT01551420|147330172|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.17||0.4589|TWO_SIDED|95.0|-0.22|0.48|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Spontaneity at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Spontaneity measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.48|-0.22|0.4589
73899462|NCT01551420|147330172|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.18||0.711|TWO_SIDED|95.0|-0.31|0.44|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Skill at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Skill measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.44|-0.31|0.7110
73899463|NCT01551420|147330173|SUPERIORITY||Mean Difference (Net)|253.6|STANDARD_DEVIATION|325.2|<|0.0001|TWO_SIDED|95.0|146.7|360.5|||t-test, 2 sided|The sample for this paired t-test was 38 participants.||Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with T-MAP data at both time points).|Mean difference is the change in scores from Baseline to End of A.|360.5|146.7|<0.0001
73899464|NCT01551420|147330173|SUPERIORITY||Slope|-183.1|STANDARD_ERROR_OF_MEAN|186.9||0.3397|TWO_SIDED|95.0|-574.3|208.2|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for T-MAP at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from T-MAP measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||208.2|-574.3|0.3397
73899465|NCT01551420|147330174|SUPERIORITY||Mean Difference (Net)|4.3|STANDARD_DEVIATION|10.01||0.0465|TWO_SIDED|95.0|0.07|8.53|||t-test, 2 sided|The sample for this paired t-test was 24 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).||8.53|0.07|0.0465
73899466|NCT01551420|147330174|SUPERIORITY||Slope|-2.39|STANDARD_ERROR_OF_MEAN|2.46||0.345|TWO_SIDED|95.0|-7.6|2.82|||Regression, Linear|The sample for this analysis was 19participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||2.82|-7.60|0.3450
73899467|NCT01551420|147330175|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_DEVIATION|7.54||0.6881|TWO_SIDED|95.0|-1.86|2.79|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with CRIS: Extent of Limitations data at both time points).||2.79|-1.86|0.6881
73899468|NCT01551420|147330175|SUPERIORITY||Mean Difference (Net)|-0.72|STANDARD_DEVIATION|13.95||0.7363|TWO_SIDED|95.0|-5.01|3.67|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Perceived Limitations data at both time points).||3.67|-5.01|0.7363
73899469|NCT01551420|147330175|SUPERIORITY||Mean Difference (Net)|-1.49|STANDARD_DEVIATION|8.12||0.2361|TWO_SIDED|95.0|-3.99|1.01|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Satisfaction data at both time points).||1.01|-3.99|0.2361
73899470|NCT01551420|147330175|SUPERIORITY||Slope|-7.07|STANDARD_ERROR_OF_MEAN|4.02||0.0932|TWO_SIDED|95.0|-15.43|1.29|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Extent of Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.29|-15.43|0.0932
73899471|NCT01551420|147330175|SUPERIORITY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|6.0||0.0951|TWO_SIDED|95.0|-22.9|1.99|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Perceived Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.99|-22.9|0.0951
73899472|NCT01551420|147330175|SUPERIORITY||Slope|-4.91|STANDARD_ERROR_OF_MEAN|4.01||0.2346|TWO_SIDED|95.0|-13.3|3.43|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Satisfaction measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||3.43|-13.3|0.2346
73960127|NCT00880048|147455836|SUPERIORITY||Mean Difference (Net)|-1.58||||0.027|TWO_SIDED|95.0|-2.97|-0.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||-0.18|-2.97|0.0270
74023099|NCT00824564|147599119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|15.16||0.139|TWO_SIDED|95.0|-52.9|7.5|||t-test, 2 sided|||For 24 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||7.5|-52.9|0.139
74023100|NCT00824564|147599120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.2|STANDARD_ERROR_OF_MEAN|132.1||0.849|TWO_SIDED|95.0|-238.2|288.6|||t-test, 2 sided|||The mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||288.6|-238.2|0.849
74023101|NCT00824564|147599121|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Chi-squared|||Chi-square test was used at 5% level of significance.||||0.714
73847322|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Overall Quality Of Life Subsection score.||||||0.061
73847323|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Emotional Well-being Subsection score.||||||0.007
73847324|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Emotional Problems score.||||||0.253
73847325|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.942||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Cognitive Function Subsection score.||||||0.942
73847326|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Change in Health Subsection score.||||||0.016
73847327|NCT00755807|147240268|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Satisfaction with Sexual Function Subsection score.||||||0.381
73847328|NCT00755807|147240270|SUPERIORITY_OR_OTHER|||||||0.524||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 7). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) Model: Change from Baseline=Baseline+Investigator+Week+Baseline\*Week; participant was treated as random effect.||||||0.524
73847329|NCT00755807|147240270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 8). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
73847330|NCT00755807|147240270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 9). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
73847331|NCT00755807|147240270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 10). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
73847332|NCT00755807|147240270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 11). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
73847333|NCT00755807|147240270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 12). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
73847334|NCT00755807|147240270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 13). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
73847335|NCT00755807|147240270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 14). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
73847336|NCT00755807|147240270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 15). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
73847337|NCT00755807|147240270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 16). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
73899473|NCT01634191|147330185|OTHER||Geometric Mean Ratio|113.0|||||TWO_SIDED|90.0|94.2|135.0|||||Geometric mean ratio (Elderly/Young) and 90% confidence interval (CI) of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||135|94.2|
73899474|NCT01634191|147330187|OTHER||Geometric Mean Ratio|128.0|||||TWO_SIDED|90.0|107.0|154.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||154|107|
73899475|NCT01634191|147330188|OTHER||Geometric Mean Ratio|113.0|||||TWO_SIDED|90.0|94.1|135.0|||||Geometric mean ratio (Elderly/Young) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||135|94.1|
73899476|NCT01634191|147330189|OTHER||Geometric Mean Ratio|131.0|||||TWO_SIDED|90.0|109.0|157.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||157|109|
73899477|NCT01634191|147330190|OTHER||Geometric Mean Ratio|106.0|||||TWO_SIDED|90.0|90.5|123.0|||||Geometric mean ratio (Elderly/Young) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||123|90.5|
73899478|NCT01634191|147330191|OTHER||Geometric Mean Ratio|108.0|||||TWO_SIDED|90.0|92.3|126.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||126|92.3|
73899479|NCT01634191|147330192|OTHER||Median Difference|0.5||||0.153|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test||Median difference (Elderly - Young) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.000|0.153
73899480|NCT01634191|147330193|OTHER||Median Difference|0.5||||0.169|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test||Median difference (Female - Male) and 90% CI of the difference calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.000|0.169
73899481|NCT01527357|147330232|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
73899482|NCT01527357|147330233|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
73899483|NCT01527357|147330234|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
74023102|NCT00824564|147599122|SUPERIORITY_OR_OTHER||Least square means difference|0.37|STANDARD_ERROR_OF_MEAN|0.295||0.208|TWO_SIDED|95.0|-0.21|0.96|||Mixed Models Analysis|||For change at end of surgery, a Mixed Model Repeated Measures (MMRM) approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.96|-0.21|0.208
73899484|NCT01527357|147330235|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
73899485|NCT02446171|147330240|SUPERIORITY_OR_OTHER||Ratio#|98.89|||||TWO_SIDED|90.0|92.4|105.84|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||105.84|92.40|
73899486|NCT02446171|147330240|SUPERIORITY_OR_OTHER||Ratio#|100.04|||||TWO_SIDED|90.0|93.17|107.43|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||107.43|93.17|
73899487|NCT02446171|147330240|SUPERIORITY_OR_OTHER||Ratio#|94.37|||||TWO_SIDED|90.0|88.7|100.4|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||100.40|88.70|
73899488|NCT02446171|147330241|SUPERIORITY_OR_OTHER||Ratio#|98.79|||||TWO_SIDED|90.0|92.24|105.8|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||105.80|92.24|
73899489|NCT02446171|147330241|SUPERIORITY_OR_OTHER||Ratio#|100.44|||||TWO_SIDED|90.0|93.65|107.72|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||107.72|93.65|
73899490|NCT02446171|147330241|SUPERIORITY_OR_OTHER||Ratio#|94.83|||||TWO_SIDED|90.0|89.2|100.82|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||100.82|89.20|
73899491|NCT02446171|147330242|SUPERIORITY_OR_OTHER||Ratio#|97.05|||||TWO_SIDED|90.0|88.09|106.92|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||106.92|88.09|
73899492|NCT02446171|147330242|SUPERIORITY_OR_OTHER||Ratio#|100.56|||||TWO_SIDED|90.0|91.8|110.16|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||110.16|91.80|
73899493|NCT02446171|147330242|SUPERIORITY_OR_OTHER||Ratio#|102.5|||||TWO_SIDED|90.0|93.13|111.82|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||111.82|93.13|
73847338|NCT00755807|147240270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 17). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
73847339|NCT00755807|147240270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 18). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
73847340|NCT00755807|147240271|SUPERIORITY_OR_OTHER|||||||0.706||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|1-sample t-test of mean change from extension phase baseline to endpoint on BDI-II Question #9 score for all participants who entered extension phase.||||||0.706
73847341|NCT00755807|147240275|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on monocytes.||||||0.035
73847342|NCT00755807|147240276|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on sodium.||||||0.042
73847343|NCT00755807|147240277|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on total protein.||||||0.036
73847344|NCT00755807|147240278|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on diastolic blood pressure.||||||0.320
73847345|NCT00755807|147240278|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on systolic blood pressure.||||||0.182
73847346|NCT00755807|147240279|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on pulse rate.||||||0.032
73847347|NCT00755807|147240280|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on weight.||||||0.151
73847348|NCT01714323|147240281|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||>|0.05|TWO_SIDED|95.0|0.84|1.37|||Chi-squared|||Data from all three sites were combined after determining that outcomes did not vary by hospital using Breslow-Day tests. The proportion abstinent by treatment arm was assessed using chi-square test.||1.37|0.84|>0.05
73847349|NCT01714323|147240282|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73847350|NCT01714323|147240283|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||This compares at Month 1||||<0.001
73847351|NCT01714323|147240283|SUPERIORITY||||||<|0.01|||||||Chi-squared|||This is analysis for Month 3||||<0.01
73847352|NCT01714323|147240283|SUPERIORITY||||||<|0.09|||||||Chi-squared|||This is for Month 6||||<0.09
73847353|NCT01714323|147240285|SUPERIORITY_OR_OTHER||||||<|0.001||||||This is the p value for the comparison at each follow up point: 1 mo, 3 mo, and 6 mo.|Chi-squared|||||||<0.001
73847354|NCT01714323|147240286|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73847355|NCT01714323|147240287|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73847356|NCT03531814|147240291|OTHER|||||||0.006||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 1-4.|ANOVA|||||||0.006
73847357|NCT03531814|147240291|OTHER|||||||0.021||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 5-8.|ANOVA|||||||0.021
73847358|NCT03531814|147240291|OTHER|||||||0.034||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 9-12.|ANOVA|||||||.034
73847359|NCT03531814|147240291|OTHER|||||||0.04||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 13-18.|ANOVA|||||||.040
73847360|NCT03531814|147240292|OTHER||Spearman's correlation|-0.21||||0.536|TWO_SIDED|95.0|-0.729|0.463||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.463|-0.729|0.536
73847361|NCT03531814|147240292|OTHER||Spearman's correlation|0.134||||0.713|TWO_SIDED|95.0|-0.557|0.715||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.715|-0.557|.713
73847362|NCT03531814|147240292|OTHER||Spearman's correlation|0.095||||0.823|TWO_SIDED|95.0|-0.668|0.761||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.761|-0.668|.823
73847363|NCT03531814|147240292|OTHER||Spearman's correlation|0.333||||0.42|TWO_SIDED|95.0|-0.505|0.848||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.848|-0.505|.420
73847364|NCT03531814|147240293|OTHER||Spearman's correlation|-0.333||||0.317|TWO_SIDED|95.0|-0.785|0.352||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.352|-0.785|0.317
73847365|NCT03531814|147240293|OTHER||Spearman's correlation|-0.309||||0.385|TWO_SIDED|95.0|-0.794|0.416||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.416|-0.794|.385
73847366|NCT03531814|147240293|OTHER||Spearman's correlation|-0.259||||0.535|TWO_SIDED|95.0|-0.824|0.563||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.563|-0.824|.535
73847367|NCT03531814|147240293|OTHER||Spearman's correlation|-0.222||||0.597|TWO_SIDED|95.0|-0.811|0.589||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.589|-0.811|.597
73847368|NCT03531814|147240294|OTHER||Spearman's correlation|-0.215||||0.526|TWO_SIDED|95.0|-0.731|0.459||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.459|-0.731|0.526
73847369|NCT03531814|147240294|OTHER||Spearman's correlation|0.049||||0.894|TWO_SIDED|95.0|-0.613|0.67||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.670|-0.613|.894
73847370|NCT03531814|147240294|OTHER||Spearman's correlation|-0.048||||0.911|TWO_SIDED|95.0|-0.74|0.694||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12|Spearman correlation (non-parametric)|||||0.694|-0.740|.911
73847371|NCT03531814|147240294|OTHER||Spearman's correlation|-0.167||||0.693|TWO_SIDED|95.0|-0.79|0.626||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18|Spearman correlation (non-parametric)|||||0.626|-0.790|.693
73847372|NCT03531814|147240295|OTHER||Spearman's correlation|-0.607||||0.048|TWO_SIDED|95.0|-0.889|0.009||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.009|-0.889|0.048
73847373|NCT03531814|147240295|OTHER||Spearman's correlation|-0.658||||0.038|TWO_SIDED|95.0|-0.914|-0.027||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||-0.027|-0.914|0.038
73847374|NCT03531814|147240295|OTHER||Spearman's correlation|-0.708||||0.5|TWO_SIDED|95.0|-0.945|0.02||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.020|-0.945|0.50
73847375|NCT03531814|147240295|OTHER||Spearman's correlation|-0.878||||0.004|TWO_SIDED|95.0|-0.979|-0.435||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||-0.435|-0.979|0.004
73960128|NCT00880048|147455836|SUPERIORITY||Mean Difference (Net)|-1.86||||0.0103|TWO_SIDED|95.0|-3.27|-0.44|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.44|-3.27|0.0103
73847376|NCT03531814|147240296|OTHER||Spearman's correlation|0.293||||0.382|TWO_SIDED|95.0|-0.39|0.768||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.768|-0.390|0.382
73847377|NCT03531814|147240296|OTHER||Spearman's correlation|0.278||||0.436|TWO_SIDED|95.0|-0.444|0.781||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.781|-0.444|0.436
73847378|NCT03531814|147240296|OTHER||Spearman's correlation|0.229||||0.586|TWO_SIDED|95.0|-0.585|0.813||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.813|-0.585|0.586
73847379|NCT03531814|147240296|OTHER||Spearman's correlation|0.53||||0.177|TWO_SIDED|95.0|-0.302|0.904||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.904|-0.302|0.177
73847380|NCT03531814|147240298|OTHER||Spearman's correlation|-0.576||||0.063|TWO_SIDED|95.0|-0.879|0.056||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.056|-0.879|0.063
73847381|NCT03531814|147240298|OTHER||Spearman's correlation|-0.68||||0.031|TWO_SIDED|95.0|-0.92|-0.066||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Wilcoxon (Mann-Whitney)|||||-0.066|-0.920|0.031
73847382|NCT03531814|147240298|OTHER||Spearman's correlation|-0.835||||0.01|TWO_SIDED|95.0|-0.971|-0.292||The reported p-value represents the strength of the relationship between the variables at cycles 9-12.|Spearman correlation (non-parametric)|||||-0.292|-0.971|0.010
73847383|NCT03531814|147240298|OTHER||Spearman's correlation|-0.933|||<|0.001|TWO_SIDED|95.0|-0.989|-0.652||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||-0.652|-0.989|<0.001
73847384|NCT03531814|147240299|OTHER||Spearman's correlation|-0.035||||0.919|TWO_SIDED|95.0|-0.634|0.591||The reported p-value represents the strength of the relationship between the variables for cycles 1-4.|Spearman correlation|||||0.591|-0.634|0.919
73960129|NCT00880048|147455836|SUPERIORITY||Mean Difference (Net)|-1.53||||0.0497|TWO_SIDED|95.0|-3.06|0.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||-0.00|-3.06|0.0497
73847385|NCT03531814|147240299|OTHER||Spearman's correlation|0.227||||0.528|TWO_SIDED|95.0|-0.487|0.759||The reported p-value represents the strength of the relationship between the variables for cycles 5-8.|Spearman correlation|||||0.759|-0.487|0.528
73847386|NCT03531814|147240299|OTHER||Spearman's correlation|0.179||||0.672|TWO_SIDED|95.0|-0.618|0.794||The reported p-value represents the strength of the relationship between the variables for cycles 9-12.|Spearman correlation|||||0.794|-0.618|0.672
73847387|NCT03531814|147240299|OTHER||Spearman's correlation|0.041||||0.923|TWO_SIDED|95.0|-0.697|0.737||The reported p-value represents the strength of the relationship between the variables for cycles 13-18.|Spearman correlation|||||0.737|-0.697|0.923
73847388|NCT03531814|147240300|OTHER||Spearman's correlation|-0.638||||0.035|TWO_SIDED|95.0|-0.899|-0.041||The reported p-value represents the strength of the relationship between the variables for cycles 1-4.|Spearman correlation|||||-0.041|-0.899|0.035
73847389|NCT03531814|147240300|OTHER||Spearman's correlation|-0.361||||0.306|TWO_SIDED|95.0|-0.815|0.367||The reported p-value represents the strength of the relationship between the variables for cycles 5-8.|Spearman correlation|||||0.367|-0.815|0.306
73847390|NCT03531814|147240300|OTHER||Spearman's correlation|-0.407||||0.317|TWO_SIDED|95.0|-0.87|0.438||The reported p-value represents the strength of the relationship between the variables for cycles 9-12.|Spearman correlation|||||0.438|-0.870|0.317
73960130|NCT00880048|147455836|SUPERIORITY||Mean Difference (Net)|-1.41||||0.0794|TWO_SIDED|95.0|-2.98|0.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.17|-2.98|0.0794
73960131|NCT00880048|147455837|SUPERIORITY||Mean Difference (Net)|-0.28||||0.24|TWO_SIDED|95.0|-0.75|0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.19|-0.75|0.2400
73960132|NCT00880048|147455837|SUPERIORITY||Mean Difference (Net)|-0.76||||0.002|TWO_SIDED|95.0|-1.23|-0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.28|-1.23|0.0020
73960133|NCT00880048|147455837|SUPERIORITY||Mean Difference (Net)|-0.15||||0.5605|TWO_SIDED|95.0|-0.67|0.36|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.36|-0.67|0.5605
73847391|NCT03531814|147240300|OTHER||Spearman's correlation|-0.18||||0.67|TWO_SIDED|95.0|-0.795|0.0617||The reported p-value represents the strength of the relationship between the variables for cycles 13-18.|Spearman correlation|||||0.0617|-0.795|0.670
73847392|NCT00952705|147240321|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV-BFS A/H1N1.|Ratio of geometric mean titers|0.95|||||TWO_SIDED|95.0|0.87|1.03|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.03|0.87|
73847393|NCT00952705|147240321|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV-BFS A/H3N2.|Ratio of geometric mean titers|0.93|||||TWO_SIDED|95.0|0.85|1.0|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.00|0.85|
73847394|NCT00952705|147240321|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: FluMist B/Yamagata divided by Q/LAIV-BFS B/Yamagata.|Ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.79|1.02|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.02|0.79|
73847395|NCT00952705|147240321|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: FluMist B/Victoria divided by Q/LAIV-BFS B/Victoria.|Ratio of geometric mean titers|0.97|||||TWO_SIDED|95.0|0.87|1.1|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.10|0.87|
73847396|NCT02921789|147240349|SUPERIORITY||Difference|-12.7||||0.3705|TWO_SIDED|95.0|-34.5|9.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||||9.0|-34.5|0.3705
73847397|NCT02921789|147240350|SUPERIORITY||Difference|-12.7||||0.3705|TWO_SIDED|95.0|-34.5|9.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||9.0|-34.5|0.3705
73847398|NCT02921789|147240350|SUPERIORITY||Difference|-12.4||||0.389|TWO_SIDED|95.0|-35.8|11.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||11.0|-35.8|0.3890
73847399|NCT02921789|147240351|SUPERIORITY||Difference|6.9||||0.752|TWO_SIDED|95.0|-15.3|29.2||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 3||29.2|-15.3|0.7520
73847400|NCT02921789|147240351|SUPERIORITY||Difference|6.9||||0.752||95.0|-15.3|29.2||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||29.2|-15.3|0.7520
73847401|NCT02921789|147240351|SUPERIORITY||Difference|5.0||||0.7597|TWO_SIDED|95.0|-18.9|29.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||29.0|-18.9|0.7597
73847402|NCT02921789|147240352|SUPERIORITY||Difference|-0.3||||1||95.0|-24.9|24.3||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||||24.3|-24.9|1.0
73847403|NCT02921789|147240353|SUPERIORITY||Difference|-3.9||||1||95.0|-30.2|22.4||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 3||22.4|-30.2|1.0
73847404|NCT02921789|147240353|SUPERIORITY||Difference|-6.2||||0.772||95.0|-31.7|19.3||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||19.3|-31.7|0.7720
73847405|NCT02921789|147240353|SUPERIORITY||Difference|-7.5||||0.772||95.0|-32.6|17.6||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||17.6|-32.6|0.7720
73960134|NCT00880048|147455837|SUPERIORITY||Mean Difference (Net)|-0.33||||0.2215|TWO_SIDED|95.0|-0.86|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.20|-0.86|0.2215
73899494|NCT03811093|147330258|SUPERIORITY||Mean Difference (Net)|2.036|||<|0.01|TWO_SIDED|95.0|1.243|2.828||p-value is calculated using SPSS.|t-test, 2 sided|||The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. Change in Body Fat Percentage.||2.828|1.243|<0.01
73899495|NCT03811093|147330258|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Percent of Body Fat Lost or Gained is normal with mean -.83 and standard deviation 1.50218."||||0.20
73899496|NCT03811093|147330258|OTHER|||||||0.075|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||0.075
73899497|NCT03811093|147330259|SUPERIORITY||Mean Difference (Net)|7.063|||<|0.01|TWO_SIDED|95.0|3.829|10.296||p-value is calculated using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change over time in measured body circumference. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. measured body circumference.||10.296|3.829|<0.01
73899498|NCT03811093|147330259|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Total Inches Lost or Gained is normal with mean -7.136 and standard deviation 5.796."||||0.20
73899499|NCT03811093|147330259|OTHER|||||||0.44|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||0.44
73899500|NCT03811093|147330260|SUPERIORITY||Mean Difference (Net)|4.4703|||<|0.01|TWO_SIDED|95.0|2.3372|6.6034||p-value is computed using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change in body fat, measured in pounds. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. change in pounds of body fat.||6.6034|2.3372|<0.01
73899501|NCT03811093|147330260|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of the Weight of Body Fat Lost or Gained is normal with mean -2.49 and standard deviation 3.71209."||||.200
73899502|NCT03811093|147330260|OTHER|||||||0.438|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||.438
73899503|NCT00464490|147330261|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value \<0.05 was considered significant|t-test, 2 sided|||H(0): Ventilator time (DG) = Ventilator time (CG)||||0.02
73899504|NCT01475071|147330292|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority margin of -10%|Mean Difference (Final Values)|-3.5|STANDARD_DEVIATION|15.6||0.0345|ONE_SIDED|95.0|-6.8||||paired Student's t statistic|||The primary purpose of this study is to demonstrate the non-inferiority of Metvix and daylight compared to Metvix and the lamp in terms of lesion complete response rate.|||-6.8|0.0345
73899505|NCT01475071|147330293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_DEVIATION|2.7|<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided Wilcoxon rank signed||superiority of Metvix adaylight and Metvix Lamp in term of pain||||<0.001
74023103|NCT00824564|147599122|SUPERIORITY_OR_OTHER||Least square means difference|0.1|STANDARD_ERROR_OF_MEAN|0.255||0.682|TWO_SIDED|95.0|-0.4|0.61|||Mixed Models Analysis|||For change at 1 hour post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.61|-0.40|0.682
73960135|NCT00880048|147455837|SUPERIORITY||Mean Difference (Net)|-0.35||||0.287|TWO_SIDED|95.0|-1.01|0.3|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.30|-1.01|0.2870
74023104|NCT00824564|147599122|SUPERIORITY_OR_OTHER||Least square means difference|0.14|STANDARD_ERROR_OF_MEAN|0.244||0.569|TWO_SIDED|95.0|-0.35|0.63|||Mixed Models Analysis|||For change at day 1 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.63|-0.35|0.569
73960136|NCT00880048|147455837|SUPERIORITY||Mean Difference (Net)|-0.67||||0.0465|TWO_SIDED|95.0|-1.33|-0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.01|-1.33|0.0465
73899506|NCT04456673|147330325|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Risk Difference (RD)|-0.435||||0.0002|TWO_SIDED|95.0|-0.682|-0.188|||Negative binomial model||Derived using delta method|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), ICS dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.188|-0.682|0.0002
73899507|NCT04456673|147330326|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least Square (LS) Mean Difference|0.082||||0.0001|TWO_SIDED|95.0|0.04|0.124|||MMRM model|||Derived from mixed-effect model with repeated measures (MMRM) model with the change from baseline in pre-bronchodilator FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-bronchodilator FEV1, and FEV1 baseline-by-visit interaction as covariates.||0.124|0.040|0.0001
73899508|NCT04456673|147330327|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|LS Mean Difference|-3.371||||0.0068|TWO_SIDED|95.0|-5.811|-0.931|||MMRM model|||Derived from MMRM model with the change from baseline in SGRQ total score up to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, treatment-by-visit interaction, baseline SGRQ total score, and SGRQ baseline-by-visit interaction as covariates.||-0.931|-5.811|0.0068
73899509|NCT04456673|147330328|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Odds Ratio (OR)|1.164||||0.3329|TWO_SIDED|95.0|0.856|1.581|||Regression, Logistic|||Derived from logistic regression model which includes treatment group, region (pooled country), ICS dose, smoking status at screening, and baseline SGRQ total score as covariates.||1.581|0.856|0.3329
73899510|NCT04456673|147330329|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|LS Mean Difference|0.062||||0.0182|TWO_SIDED|95.0|0.011|0.113|||MMRM model|||Derived from MMRM model with the change from baseline in pre-bronchodilator FEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-bronchodilator FEV1, and FEV1 baseline-by-visit interaction as covariates.||0.113|0.011|0.0182
73899511|NCT03874429|147330345|NON_INFERIORITY|Non- inferiority was demonstrated if the upper bound of the 95% CI was no higher than 2 points for the the difference of T2259 minus Vismed Multi.|Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.42|1.05|||ANCOVA|||To assess the non inferiority of T2259 compared to Vismed Multi, two-sided 95% confidence interval from ANCOVA model was computed of the difference of T2259 minus Vismed Multi. The model was adjusted for the main effects of investigation product and baseline score.||1.05|-0.42|
73899512|NCT00992589|147330350|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.449||||0.168|TWO_SIDED|95.0|-1.087|0.19|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in daily average frequency of regurgitation from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.190|-1.087|0.168
73899513|NCT00992589|147330351|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.03||||0.44|TWO_SIDED|95.0|-0.047|0.108|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Double-blind (DB) Baseline as covariate to test the hypothesis of no difference in change in Weight-for-Age Z-Score from DB Baseline to DB Endpoint between Rabeprazole Sodium Total and Placebo.||0.108|-0.047|0.440
73899514|NCT00992589|147330353|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.006||||0.984|TWO_SIDED|95.0|-0.619|0.632|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Regurgitation Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.632|-0.619|0.984
73899515|NCT00992589|147330354|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.182||||0.479|TWO_SIDED|95.0|-0.69|0.325|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Discomfort Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.325|-0.690|0.479
73847406|NCT01766102|147240354|OTHER|||||||0.716|||||||t-test, 2 sided|||H0: Procedure time is not significantly different based on mammography type used||||0.716
73847407|NCT01766102|147240354|OTHER|||||||0.676|||||||t-test, 2 sided|||H0: Operating room time is not significantly different based on mammography type used||||0.676
73899516|NCT00992589|147330355|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.192||||0.498|TWO_SIDED|95.0|-0.751|0.366|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Eating Behavior Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.366|-0.751|0.498
73847408|NCT05173974|147240367|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.037|TWO_SIDED|95.0|0.01|0.29||P-value included Bonferroni adjustment.|ANCOVA||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participants included as a random effect.|||0.29|0.01|0.037
73847409|NCT05173974|147240367|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.044|TWO_SIDED|95.0|0.0|0.28||P-value included Bonferroni adjustment.|ANCOVA||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participant included as a random effect.|||0.28|0.00|0.044
73847410|NCT05173974|147240367|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.005|TWO_SIDED|95.0|0.06|0.3||unadjusted P-value was presented.|ANCOVA||||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participants included as a random effect.|0.30|0.06|0.005
73847411|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.218|TWO_SIDED|95.0|-0.04|0.17|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.17|-0.04|0.218
73847412|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.034|TWO_SIDED|95.0|0.01|0.21|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.21|0.01|0.034
73847413|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.004|TWO_SIDED|95.0|0.05|0.25|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.25|0.05|0.004
73847414|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.058|TWO_SIDED|95.0|0.0|0.24|||ANCOVA||Statistical comparison for AOB 0-1|||0.24|-0.00|0.058
73847415|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.017|TWO_SIDED|95.0|0.03|0.27|||ANCOVA||Statistical comparison for AOB 0-1|||0.27|0.03|0.017
73847416|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.001|TWO_SIDED|95.0|0.09|0.33|||ANCOVA||Statistical comparison for AOB 0-1|||0.33|0.09|0.001
73847417|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.004|TWO_SIDED|95.0|0.06|0.3|||ANCOVA||Statistical comparison for AOB 0-3|||0.30|0.06|0.004
73899517|NCT00992589|147330356|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.042||||0.96|TWO_SIDED|95.0|-1.615|1.7|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in I-GERQ-R Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||1.700|-1.615|0.960
73899518|NCT00992589|147330357|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.024||||0.968|TWO_SIDED|95.0|-1.167|1.214|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in Weekly Average I-GERQ-DD Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||1.214|-1.167|0.968
73899519|NCT02142387|147330402|OTHER|||||||0.34|TWO_SIDED|95.0|||||Chi-squared|||||||0.34
73847418|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.01|TWO_SIDED|95.0|0.04|0.27|||ANCOVA||Statistical comparison for AOB0-3|||0.27|0.04|0.010
73847419|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.002|TWO_SIDED|95.0|0.07|0.31|||ANCOVA||Statistical comparison for AOB0-3|||0.31|0.07|0.002
73847420|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.022|TWO_SIDED|95.0|0.02|0.29|||ANCOVA||Statistical comparison for AOB 0-6|||0.29|0.02|0.022
73847421|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.011|TWO_SIDED|95.0|0.04|0.3|||ANCOVA||Statistical comparison for AOB 0-6|||0.30|0.04|0.011
73847422|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.005|TWO_SIDED|95.0|0.06|0.33|||ANCOVA||Statistical comparison for AOB 0-6|||0.33|0.06|0.005
73847423|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.037|TWO_SIDED|95.0|0.01|0.27|||ANCOVA||Statistical comparison for AOB 0-9|||0.27|0.01|0.037
73847424|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.013|TWO_SIDED|95.0|0.04|0.3|||ANCOVA||Statistical comparison for AOB 0-9|||0.30|0.04|0.013
73847425|NCT05173974|147240368|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.005|TWO_SIDED|95.0|0.06|0.32|||ANCOVA||Statistical comparison for AOB 0-9|||0.32|0.06|0.005
73847426|NCT03289143|147240369|SUPERIORITY|||||||0.6147||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6147
73847427|NCT03289143|147240369|SUPERIORITY|||||||0.5778||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5778
73847428|NCT03289143|147240369|SUPERIORITY|||||||0.5136||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5136
73847429|NCT03289143|147240371|SUPERIORITY|||||||0.8198||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.8198
73847430|NCT03289143|147240371|SUPERIORITY|||||||0.3961||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.3961
73847431|NCT03289143|147240371|SUPERIORITY|||||||0.6043||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6043
73847432|NCT03289143|147240372|SUPERIORITY|||||||0.0783||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.0783
73847433|NCT03289143|147240372|SUPERIORITY|||||||0.601||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6010
73847434|NCT03289143|147240372|SUPERIORITY|||||||0.3961||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.3961
73847435|NCT03289143|147240373|SUPERIORITY|||||||0.9749||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.9749
73847436|NCT03289143|147240373|SUPERIORITY|||||||0.7718||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.7718
73847437|NCT03289143|147240373|SUPERIORITY|||||||0.5789||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5789
73847438|NCT03289143|147240374|SUPERIORITY|||||||0.5235||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5235
73847439|NCT03289143|147240374|SUPERIORITY|||||||0.5612||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5612
73847440|NCT03289143|147240374|SUPERIORITY|||||||0.713||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.7130
73847441|NCT00730756|147240379|SUPERIORITY_OR_OTHER|||||||0.845||95.0|||||ANCOVA|Center, baseline eosinophils, baseline symptom score, age, and gender were included as covariates in all efficacy analyses.||||||0.845
73847442|NCT01152307|147240391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.42|STANDARD_DEVIATION|1.6||0.01|TWO_SIDED|95.0|0.76|6.09|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.||6.09|0.76|0.01
73847443|NCT01126190|147240393|NON_INFERIORITY|Non-inferiority was demonstrated if the upper endpoint of the CI for the difference in mean DSN was less than or equal to 0.62 days|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.13|0.37||||||For the primary non-inferiority endpoint of cycle 1 DSN, the 95% confidence interval (CI) for difference in DSN was calculated by stratified bootstrap resampling.||0.37|-0.13|
73847444|NCT00524121|147240400|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon signed rank test|||||||0.011
73847445|NCT00524121|147240401|SUPERIORITY_OR_OTHER|||||||0.115||95.0|||||Log Rank|||||||0.115
73847446|NCT00524121|147240402|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
73847447|NCT00524121|147240403|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
73847448|NCT00524121|147240404|SUPERIORITY_OR_OTHER|||||||0.5467|||||||Fisher Exact|||||||0.5467
73847449|NCT01114737|147240405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.3||0.085|TWO_SIDED|95.0|-8.9|0.6|||ANCOVA|Adjusted for baseline ADHD-RS/ASRS total score, age group, and ADHD medication.||||0.6|-8.9|0.085
73847450|NCT01114737|147240406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.669|TWO_SIDED|95.0|-1.5|2.3|||ANCOVA|Adjusted for baseline HAMA Anxiety Scale Total Score, age group, ADHD symptom, and ADHD medication.||||2.3|-1.5|0.669
73899520|NCT02142387|147330403|OTHER|||||||0.7|||||||Chi-squared|||||||0.7
73899521|NCT02142387|147330404|OTHER|||||||0.11|||||||Chi-squared|||||||0.11
73899522|NCT05028361|147330405|NON_INFERIORITY|One-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-5.6||||0.0007|TWO_SIDED|95.0|-15.2|4.0||The upper limit of the 95% CI of the difference was 4% with a noninferiority margin of 10%.|Cochran-Mantel-Haenszel|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting was used.||The null hypothesis is the Simultaneous group is inferior (i.e., Simultaneous group will have a higher proportion) to the Sequential group in regards to the proportion of participants with at least one moderate or severe fever, chills, myalgia, or arthralgia event after visits 1 and 2 using 10% non-inferiority margin.||4.0|-15.2|0.0007
73899523|NCT05028361|147330406|SUPERIORITY|||||||0.3851|||||||Mantel Haenszel|||||||0.3851
73899524|NCT05028361|147330407|SUPERIORITY|||||||0.2886|||||||Mantel Haenszel|||||||0.2886
73899525|NCT05028361|147330409|OTHER||Comparison of Frequencies|-0.01|||||TWO_SIDED|95.0|-1.66|1.64||The comparison in number of participants with reported SAEs regardless of relationship to study product were made using a difference in proportions along with a 95% confidence interval of the difference.||||||1.64|-1.66|
74023105|NCT00824564|147599122|SUPERIORITY_OR_OTHER||Least square means difference|0.2|STANDARD_ERROR_OF_MEAN|0.249||0.413|TWO_SIDED|95.0|-0.29|0.7|||Mixed Models Analysis|||For change at day 2 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.70|-0.29|0.413
73847451|NCT01114737|147240407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.588|TWO_SIDED|95.0|-1.1|1.9|||ANCOVA|Adjusted for Baseline HAM-D Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.||||1.9|-1.1|0.588
73847452|NCT01114737|147240408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.531|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|Adjusted for baseline CGI-Severity Response, age group, ADHD symptom, and ADHD medication.||||0.2|-0.4|0.531
73847453|NCT01114737|147240409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.2||0.661|TWO_SIDED|95.0|-5.5|3.6|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||3.6|-5.5|0.661
73847454|NCT01114737|147240410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.9||0.034|TWO_SIDED|95.0|-7.9|-0.3|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||-0.3|-7.9|0.034
73847455|NCT01114737|147240411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.6||0.312|TWO_SIDED|95.0|-2.6|7.8|||ANCOVA|Adjusted for Week 13 ADHD RS/ASRS Total Score, age group, and ADHD medication.||||7.8|-2.6|0.312
73847456|NCT01114737|147240412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.0||0.59|TWO_SIDED|95.0|-2.4|1.4|||ANCOVA|Adjusted for Week 13 HAMA Anxiety Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.||||1.4|-2.4|0.590
73847457|NCT01114737|147240413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.636|TWO_SIDED|95.0|-1.2|1.9|||ANCOVA|Adjusted for Week 13 HAMD Rating Scale Total Score, age group, ADHD symptom, and ADHD||||1.9|-1.2|0.636
73847458|NCT01114737|147240414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.51|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|Adjusted for Week 13 Global Impression-Severity Score, ADHD symptom, and ADHD medication.||||0.5|-0.2|0.510
73847459|NCT01114737|147240415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.8||0.395|TWO_SIDED|95.0|-2.1|5.2|||ANCOVA|Adjusted for Week 13 BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||5.2|-2.1|0.395
73847460|NCT01114737|147240416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.443|TWO_SIDED|95.0|-2.1|4.7|||ANCOVA|Adjusted for Week 13 BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||4.7|-2.1|0.443
73847461|NCT01114737|147240417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.8||0.953|TWO_SIDED|95.0|-5.5|5.8|||ANCOVA|Adjusted for Baseline ADHD-RS/ASRS Total Score, ADHD symptom, and ADHD medication.||||5.8|-5.5|0.953
73847462|NCT01114737|147240418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.733|TWO_SIDED|95.0|-2.4|1.7|||ANCOVA|Adjusted for Baseline Hamilton Anxiety Rating Scale (HAM-A) Score, ADHD symptom, and ADHD medication.||||1.7|-2.4|0.733
73847463|NCT01114737|147240419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.522|TWO_SIDED|95.0|-1.1|2.2|||ANCOVA|Adjusted for Baseline Hamilton Rating Scale For Depression (HAM-D) Score, ADHD symptom, and ADHD medication.||||2.2|-1.1|0.522
73847464|NCT01114737|147240420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.564|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|Adjusted for Baseline Clinical Global Impression-Severity (CGI-S), ADHD symptom, and ADHD medication.||||0.4|-0.2|0.564
73847465|NCT01114737|147240421|SUPERIORITY_OR_OTHER||Relative Risk|0.87||||0.67|TWO_SIDED|95.0|0.46|1.64|||Cochran-Mantel-Haenszel|Adjusted for age group, ADHD symptom, and ADHD medication||||1.64|0.46|0.67
73960137|NCT00880048|147455837|SUPERIORITY||Mean Difference (Net)|-0.32||||0.3399|TWO_SIDED|95.0|-0.99|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.34|-0.99|0.3399
74023106|NCT00824564|147599122|SUPERIORITY_OR_OTHER||Least square means difference|0.11|STANDARD_ERROR_OF_MEAN|0.276||0.686|TWO_SIDED|95.0|-0.44|0.66|||Mixed Models Analysis|||For change at day 4/ET post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.66|-0.44|0.686
74023107|NCT00824564|147599123|SUPERIORITY_OR_OTHER|||||||0.241|TWO_SIDED||||||Fisher Exact|||Fisher's exact test at 5% level of significance was used as the event rate was low and the expected count for any cell in the (unstratified) 2\*2 contingency table was less than 5.||||0.241
73847466|NCT01114737|147240422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.8||0.833|TWO_SIDED|95.0|-6.2|5.0|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||5.0|-6.2|0.833
73847467|NCT01114737|147240423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|2.0||0.279|TWO_SIDED|95.0|-6.3|1.8|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||1.8|-6.3|0.279
73847468|NCT00457392|147240431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.1933|TWO_SIDED|95.0|0.822|1.079||p-value was not adjusted for multiple comparisons.|Log Rank|||Differences in OS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and epidermal growth factor receptor (EGFR) status (positive, versus negative, versus unknown).||1.079|0.822|0.1933
73847469|NCT00457392|147240432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.807||||0.0023|TWO_SIDED|95.0|0.695|0.937||No p-value is adjusted for multiple comparisons for PFS.|Log Rank|One-sided log-rank test with alpha=0.025 was used.||Differences in PFS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown).||0.937|0.695|0.0023
73847470|NCT00457392|147240433|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.514||||0.0471|TWO_SIDED|95.0|1.002|2.289|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown) was used to compare ORR between the 2 treatment arms. The relative risk ratio estimator was used to contrast the treatment effects on response rates. A point estimate of relative risk ratio and 2-sided 95% CI was calculated.||2.289|1.002|0.0471
73847471|NCT02727322|147240441|SUPERIORITY||Risk Ratio (RR)|1.1||||0.97|TWO_SIDED|95.0|0.5|2.04|||Chi-squared|||||2.04|0.50|0.97
73847472|NCT02727322|147240442|SUPERIORITY||Risk Ratio (RR)|1.12||||0.665|TWO_SIDED|95.0|0.885|1.43|||Chi-squared|||||1.43|0.885|0.665
73847473|NCT02727322|147240443|SUPERIORITY||Risk Ratio (RR)|1.32||||1|TWO_SIDED|95.0|0.31|5.68|||Fisher Exact|||||5.68|0.31|1.0
73847474|NCT00339040|147240444|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.00
73847475|NCT00328172|147240503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.3271||95.0|-0.41|0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 0.5 mg versus placebo||0.14|-0.41|0.3271
73847476|NCT00328172|147240503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0032||95.0|-0.69|-0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 2.5 mg versus placebo||-0.14|-0.69|0.0032
73847477|NCT00328172|147240503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0012||95.0|-0.74|-0.18|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.18|-0.74|0.0012
73847478|NCT00328172|147240503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.1|-0.59|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Metformin versus placebo||-0.59|-1.1|<0.0001
73847479|NCT00328172|147240504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45||||0.7027||95.0|-10.0|15.1|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 0.5 mg versus placebo||15.1|-10|0.7027
73847480|NCT00328172|147240504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4||||0.003||95.0|-32.0|-6.6|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 2.5 mg versus placebo||-6.6|-32|0.003
73847481|NCT00328172|147240504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3||||0.0418||95.0|-26.0|-0.5|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.5|-26|0.0418
73847482|NCT00328172|147240504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.3|||<|0.0001||95.0|-47.0|-22.0|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||||-22|-47|< 0.0001
73847483|NCT00328172|147240505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.735||||0.413||95.0|0.464|6.492|||Regression, Logistic|||Linagliptin 0.5 mg versus placebo||6.492|0.464|0.413
73847484|NCT00328172|147240505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.157||||0.842||95.0|0.275|4.861|||Regression, Logistic|||Linagliptin 2.5 mg versus placebo||4.861|0.275|0.842
73847485|NCT00328172|147240505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.364||95.0|0.492|6.91|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||6.910|0.492|0.364
73847486|NCT00328172|147240505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.224||||0.005||95.0|1.648|16.562|||Regression, Logistic|||Metformin versus placebo||16.562|1.648|0.005
73847487|NCT00077974|147240506|SUPERIORITY_OR_OTHER||Percent|33.0||||||95.0|24.2|42.8|||||Using exact method based on binomial distribution. Percent equals n divided by N times 100.|||42.8|24.2|
73847488|NCT00856609|147240552|OTHER||Slope|-624.8||||0.01|TWO_SIDED|95.0|-901.8|-347.8|||ANCOVA|||||-347.8|-901.8|0.01
73847489|NCT00856609|147240553|OTHER||Slope|-24.0||||0.01|TWO_SIDED|95.0|-89.7|41.4|||ANCOVA|||||41.4|-89.7|0.01
73847490|NCT00856609|147240554|OTHER||Slope|-1.48||||0.05|TWO_SIDED|95.0|-3.02|0.05|||ANCOVA|||||0.05|-3.02|0.05
73847491|NCT01088503|147240555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7108|TWO_SIDED|95.0|0.88|1.22||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank|||||1.22|0.88|0.7108
74023108|NCT00486902|147599124|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Fisher Exact|||Sample size was determined assuming an incidence of breakthrough pain of 75% and an absolute difference between groups of -20 to +15%. This rate of request for analgesia in the first 24 h was based on data from a parallel study utilizing the same multimodal postoperative pain regimen for cesarean delivery. Group sample sizes of 90 achieve 80% power to detect this difference using the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.05.||||0.86
74023109|NCT00486902|147599125|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
73847492|NCT01088503|147240556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.464|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with DES vs BMS.|||||
73847493|NCT01088503|147240556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with STEMI vs not STEMI|||||
73847494|NCT01088503|147240556|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.657|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were Other Race vs Caucasian.|||||
73847495|NCT01088503|147240556|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.684|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had cardiogenic shock within 24 hours vs no cardiogenic shock within 24 hours.|||||
73847496|NCT01088503|147240556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.195|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were male vs not male.|||||
73847497|NCT01088503|147240556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with EQ-5D US index = 1 vs. \<1.|||||
73847498|NCT01088503|147240556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.116|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were married vs not married.|||||
73847499|NCT01088503|147240556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.125|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had diabetes vs no diabetes.|||||
73847500|NCT01088503|147240556|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.172|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with no BMS or DES placement vs BMS.|||||
73847501|NCT01088503|147240557|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.1882|TWO_SIDED|95.0|0.88|1.93||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank||Hazard ratio (HR) is for the analysis at 12 months.|||1.93|0.88|0.1882
73847502|NCT01088503|147240558|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.967|||||TWO_SIDED|95.0|0.849|1.103|||||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|||1.103|0.849|
73899526|NCT02047318|147330416|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-94.4|STANDARD_DEVIATION|98.915||0.0012|TWO_SIDED|95.0|-145.26|-43.55||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||-43.55|-145.26|0.0012
73847503|NCT01088503|147240562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had pre-procedure hemoglobin evaluation vs no hemoglobin evaluation.|||||
73847504|NCT01088503|147240563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.005|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with Duke CAD Index vs no Duke CAD Index.|||||
73847505|NCT00110214|147240564|NON_INFERIORITY_OR_EQUIVALENCE|Superiority and futility analyses were conducted for the OS end point. The Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain the overall significance level of alpha=0.05 while conducting interim analyses on OS. The final analysis was performed when 748 deaths had been observed. An intention-to-treat approach was used in the analysis for all the clinical end points with the exception of toxicity.|Hazard Ratio (HR)|0.91||||0.181|TWO_SIDED|95.0|0.7|1.05||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (\<10%,10%-29.9%,\>=30%), age (\<65, \>=65 years) and prior history of arterial events (yes, no)).|Log Rank|||||1.05|0.7|0.181
73960138|NCT00880048|147455837|SUPERIORITY||Mean Difference (Net)|-0.18||||0.5931|TWO_SIDED|95.0|-0.86|0.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.49|-0.86|0.5931
74023110|NCT00486902|147599126|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.24
74023111|NCT00486902|147599127|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Fisher Exact|||||||0.87
74023112|NCT00486902|147599128|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Fisher Exact|||||||0.90
73847506|NCT00110214|147240565|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73847507|NCT00110214|147240566|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||<|0.001|TWO_SIDED|95.0|0.71|0.91||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (\<10%,10%-29.9%,\>=30%), age (\<65, \>=65 years) and prior history of arterial events (yes, no)).|Log Rank|||||0.91|0.71|<0.001
73847508|NCT05525910|147240605|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|105.03|||||TWO_SIDED|90.0|94.54|116.68||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||116.68|94.54|
73847509|NCT05525910|147240605|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.15|||||TWO_SIDED|90.0|98.08|121.47||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||121.47|98.08|
73847510|NCT05525910|147240605|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|100.72|||||TWO_SIDED|90.0|90.79|111.74||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||111.74|90.79|
74023113|NCT00486902|147599129|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Fisher Exact|||||||0.24
74023114|NCT00486902|147599130|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
73847511|NCT05525910|147240605|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|110.45|||||TWO_SIDED|90.0|99.58|122.52||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||122.52|99.58|
73847512|NCT05525910|147240606|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|104.86|||||TWO_SIDED|90.0|93.78|117.24||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||117.24|93.78|
73847513|NCT05525910|147240606|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.7|||||TWO_SIDED|90.0|97.93|122.89||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||122.89|97.93|
73847514|NCT05525910|147240606|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|100.14|||||TWO_SIDED|90.0|89.69|111.8||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||111.80|89.69|
73847515|NCT05525910|147240606|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|109.8|||||TWO_SIDED|90.0|98.36|122.57||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||122.57|98.36|
73847516|NCT05525910|147240607|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.85|||||TWO_SIDED|90.0|94.97|127.06||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||127.06|94.97|
73847517|NCT05525910|147240607|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|114.69|||||TWO_SIDED|90.0|98.92|132.98||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||132.98|98.92|
73847518|NCT05525910|147240607|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|109.26|||||TWO_SIDED|90.0|94.64|126.14||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||126.14|94.64|
73847519|NCT05525910|147240607|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|115.98|||||TWO_SIDED|90.0|100.48|133.87||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||133.87|100.48|
73847520|NCT05525910|147240608|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.85|||||TWO_SIDED|90.0|76.24|103.53||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||103.53|76.24|
73847521|NCT05525910|147240608|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|95.11|||||TWO_SIDED|90.0|81.41|111.11||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||111.11|81.41|
73899527|NCT02047318|147330417|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-141.94|STANDARD_DEVIATION|117.992||0.032|TWO_SIDED|95.0|-265.77|-18.12||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed over time (with Week 252 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||-18.12|-265.77|0.032
73847522|NCT05525910|147240608|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|85.74|||||TWO_SIDED|90.0|73.73|99.7||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||99.70|73.73|
73847523|NCT05525910|147240608|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|93.12|||||TWO_SIDED|90.0|80.09|108.26||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||108.26|80.09|
73847524|NCT05525910|147240609|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.43|||||TWO_SIDED|90.0|74.64|104.78||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||104.78|74.64|
73847525|NCT05525910|147240609|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|96.0|||||TWO_SIDED|90.0|80.8|114.06||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||114.06|80.80|
73847526|NCT05525910|147240609|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|84.11|||||TWO_SIDED|90.0|71.15|99.43||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||99.43|71.15|
73899528|NCT02047318|147330418|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-1.095|STANDARD_DEVIATION|0.7173|<|0.0001|TWO_SIDED|95.0|-1.464|-0.726||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) scores was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||-0.726|-1.464|< 0.0001
73899529|NCT02047318|147330419|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Obs) scores from baseline over time (to Week 158) was statistically significant.|Mean Difference (Net)|-0.958|STANDARD_DEVIATION|0.7868||0.0307|TWO_SIDED|95.0|-1.784|-0.132||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 158 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) scores was observed over time (with Week 158 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||-0.132|-1.784|0.0307
73899530|NCT02047318|147330422|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|7.4|STANDARD_DEVIATION|210.32||0.8863|TWO_SIDED|95.0|-100.7|115.6||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||115.6|-100.7|0.8863
73899531|NCT02047318|147330423|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-184.3|STANDARD_DEVIATION|322.22||0.22|TWO_SIDED|95.0|-522.5|153.8||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||153.8|-522.5|0.22
73899532|NCT02047318|147330424|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|51.6|STANDARD_DEVIATION|89.77||0.0307|TWO_SIDED|95.0|5.4|97.7||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||97.7|5.4|0.0307
73899533|NCT02047318|147330425|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|42.3|STANDARD_DEVIATION|140.41||0.4934|TWO_SIDED|95.0|-105.0|189.7||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed over time (with Week 252 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||189.7|-105|0.4934
73899534|NCT02047318|147330426|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in AST levels between MRX baseline and Week 48 was statistically significant|Mean Difference (Net)|21.2|STANDARD_DEVIATION|58.98||0.1571|TWO_SIDED|95.0|-9.1|51.6||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in AST levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||51.6|-9.1|0.1571
74023115|NCT00486902|147599131|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.6||||0.02|TWO_SIDED|95.0|-1.1|-0.09|||Wilcoxon (Mann-Whitney)|||||-0.09|-1.1|0.02
74023116|NCT01552057|147599139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0988|TWO_SIDED|95.0|-0.7|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||0.06|-0.70|0.0988
73847527|NCT05525910|147240609|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|90.99|||||TWO_SIDED|90.0|76.99|107.54||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||107.54|76.99|
73847528|NCT05525910|147240610|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|82.65|||||TWO_SIDED|90.0|65.85|103.74||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||103.74|65.85|
73847529|NCT05525910|147240610|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|94.85|||||TWO_SIDED|90.0|75.28|119.49||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||119.49|75.28|
73847530|NCT05525910|147240610|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|81.56|||||TWO_SIDED|90.0|65.18|102.07||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||102.07|65.18|
73847531|NCT05525910|147240610|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|88.38|||||TWO_SIDED|90.0|70.65|110.57||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||110.57|70.65|
73847532|NCT00448448|147240635|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.93|||<|0.0267|TWO_SIDED|95.0|1.08|3.46|||Regression, Logistic|The success rate was adjusted for the propensity score (probability of receiving a brace) and the duration of follow-up.||||3.46|1.08|<0.0267
73847533|NCT04436744|147240728|SUPERIORITY|||||||0.0433|||||||t-test, 2 sided|||||||0.0433
73847534|NCT04436744|147240729|SUPERIORITY||Difference in Overall Response Rates|-0.93||||0.8272|TWO_SIDED|95.0|-14.66|12.81|||Cochran-Mantel-Haenszel|||ORR was calculated using the stratified Cochran-Mantel-Haenszel test.||12.81|-14.66|0.8272
73847535|NCT04436744|147240730|SUPERIORITY||Difference in Rate|6.86|||||TWO_SIDED|95.0|-4.25|17.97||||||||17.97|-4.25|
73847536|NCT01374425|147240786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0555|TWO_SIDED|95.0|0.61|1.01||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||Hazard ratio (HR) (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low excision repair cross-complementing (ERCC)-1 level and region of enrollment.||1.01|0.61|0.0555
73847537|NCT01374425|147240787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3944|TWO_SIDED|95.0|0.56|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.26|0.56|0.3944
73847538|NCT01374425|147240788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0786|TWO_SIDED|95.0|0.55|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.03|0.55|0.0786
73847539|NCT01374425|147240789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9576|TWO_SIDED|95.0|0.77|1.28||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.28|0.77|0.9576
73847540|NCT01374425|147240790|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.1658|TWO_SIDED|95.0|0.93|1.53||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.53|0.93|0.1658
73847541|NCT01374425|147240791|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.3019|TWO_SIDED|95.0|0.41|1.32||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.32|0.41|0.3019
73899535|NCT02047318|147330427|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in AST levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|12.2|STANDARD_DEVIATION|101.84||0.7815|TWO_SIDED|95.0|-94.7|119.0||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in AST levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||119|-94.7|0.7815
73899536|NCT02047318|147330428|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in GGT levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-3.9|STANDARD_DEVIATION|257.78||0.9513|TWO_SIDED|95.0|-136.4|128.7||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in GGT levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||128.7|-136.4|0.9513
73960139|NCT00880048|147455838|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0562|TWO_SIDED|95.0|0.97|8.22|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1||8.22|0.97|0.0562
74023117|NCT01552057|147599140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0003|TWO_SIDED|95.0|-0.76|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.22|-0.76|0.0003
73847542|NCT01374425|147240792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.6035|TWO_SIDED|95.0|0.48|1.53||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.53|0.48|0.6035
74023118|NCT01552057|147599141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0012|TWO_SIDED|95.0|-0.71|-0.18||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.18|-0.71|0.0012
73847543|NCT01374425|147240793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4032|TWO_SIDED|95.0|0.54|1.28||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.28|0.54|0.4032
73847544|NCT01374425|147240794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0647|TWO_SIDED|95.0|0.41|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.03|0.41|0.0647
73847545|NCT01374425|147240795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0861|TWO_SIDED|95.0|0.56|1.04||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.04|0.56|0.0861
74023119|NCT01552057|147599142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.35||||0.0073|TWO_SIDED|95.0|-9.26|-1.45||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-1.45|-9.26|0.0073
73847546|NCT01374425|147240796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3295|TWO_SIDED|95.0|0.51|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.26|0.51|0.3295
73847547|NCT01374425|147240797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.1519|TWO_SIDED|95.0|0.49|1.12||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.12|0.49|0.1519
73960140|NCT00880048|147455838|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1596|TWO_SIDED|95.0|0.73|6.73|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1||6.73|0.73|0.1596
73847548|NCT01374425|147240798|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2774|TWO_SIDED|95.0|0.87|1.62||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.62|0.87|0.2774
73847549|NCT01374425|147240799|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|4.3|||||TWO_SIDED|95.0|-5.5|14.0|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||14.0|-5.5|
73847550|NCT01374425|147240800|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|9.4|||||TWO_SIDED|95.0|7.2|26.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||26.1|7.2|
73847551|NCT01374425|147240801|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|2.1|||||TWO_SIDED|95.0|-9.9|14.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||14.1|-9.9|
73847552|NCT01374425|147240802|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-3.7|||||TWO_SIDED|95.0|-14.0|6.6|||||The difference was calculated as the percentage of participants with objective response in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||6.6|-14.0|
73847553|NCT01374425|147240803|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|2.1|||||TWO_SIDED|95.0|-7.6|3.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||3.3|-7.6|
73847554|NCT01374425|147240804|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-8.7|||||TWO_SIDED|95.0|-19.1|1.7|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||1.7|-19.1|
73847555|NCT01374425|147240805|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|2.3|||||TWO_SIDED|95.0|-3.7|8.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||8.3|-3.7|
73847556|NCT01374425|147240806|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-4.5|||||TWO_SIDED|95.0|-10.6|1.5|||||The difference was calculated as the percentage of participants with disease control in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||1.5|-10.6|
73847557|NCT01374425|147240807|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-4.0|||||TWO_SIDED|95.0|-15.9|7.8|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||7.8|-15.9|
73847558|NCT01374425|147240808|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-6.5|||||TWO_SIDED|95.0|-16.3|3.3|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||3.3|-16.3|
73960141|NCT00880048|147455838|SUPERIORITY||Odds Ratio (OR)|2.91||||0.0067|TWO_SIDED|95.0|1.34|6.3|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2||6.30|1.34|0.0067
73847559|NCT01374425|147240809|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-11.0|||||TWO_SIDED|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||11.1|-33.1|
73847560|NCT01374425|147240810|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-11.0|||||TWO_SIDED|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||11.1|-33.1|
73847561|NCT01374425|147240811|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-3.0|||||TWO_SIDED|95.0|-10.1|4.2|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||4.2|-10.1|
73847562|NCT01374425|147240812|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-5.5|||||TWO_SIDED|95.0|-11.5|0.4|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||0.4|-11.5|
73960142|NCT00880048|147455838|SUPERIORITY||Odds Ratio (OR)|1.93||||0.1154|TWO_SIDED|95.0|0.85|4.36|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2||4.36|0.85|0.1154
73960143|NCT00880048|147455838|SUPERIORITY||Odds Ratio (OR)|1.13||||0.6895|TWO_SIDED|95.0|0.62|2.07|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4||2.07|0.62|0.6895
73960144|NCT00880048|147455838|SUPERIORITY||Odds Ratio (OR)|1.32||||0.3654|TWO_SIDED|95.0|0.72|2.41|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4||2.41|0.72|0.3654
73960145|NCT00880048|147455838|SUPERIORITY||Odds Ratio (OR)|1.44||||0.2408|TWO_SIDED|95.0|0.78|2.65|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6||2.65|0.78|0.2408
73960146|NCT00880048|147455838|SUPERIORITY||Odds Ratio (OR)|1.39||||0.3066|TWO_SIDED|95.0|0.74|2.6|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6||2.60|0.74|0.3066
73960147|NCT00880048|147455839|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1472|TWO_SIDED|95.0|-0.36|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.05|-0.36|0.1472
74023120|NCT01552057|147599143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.34||||0.0049|TWO_SIDED|95.0|1.32|7.35||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Physical Functioning||7.35|1.32|0.0049
74023121|NCT01552057|147599143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.76||||0.0003|TWO_SIDED|95.0|3.57|11.94||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Physical||11.94|3.57|0.0003
74023122|NCT01552057|147599143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.67||||0.0002|TWO_SIDED|95.0|2.76|8.59||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Bodily Pain||8.59|2.76|0.0002
74023123|NCT01552057|147599143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.25||||0.0192|TWO_SIDED|95.0|0.53|5.96||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||General Health||5.96|0.53|0.0192
74023124|NCT01552057|147599143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7||||0.0002|TWO_SIDED|95.0|3.15|10.25||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Vitality||10.25|3.15|0.0002
74023125|NCT01552057|147599143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.04||||0.0014|TWO_SIDED|95.0|2.74|11.34||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Social Functioning||11.34|2.74|0.0014
74023126|NCT01552057|147599143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.12||||0.0002|TWO_SIDED|95.0|4.41|13.83||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Emotional||13.83|4.41|0.0002
74023127|NCT01552057|147599143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.91|||<|0.0001|TWO_SIDED|95.0|4.39|11.43||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Mental Health||11.43|4.39|<0.0001
74023128|NCT01552057|147599144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.85||||0.0002|TWO_SIDED|95.0|-4.32|-1.38||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-1.38|-4.32|0.0002
74023129|NCT01552057|147599145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0029|TWO_SIDED|95.0|-2.12|-0.44||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||WPI||-0.44|-2.12|0.0029
74023130|NCT01552057|147599145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0906|TWO_SIDED|95.0|-0.79|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Symptom Severity||0.06|-0.79|0.0906
74023131|NCT01552057|147599146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0755|TWO_SIDED|95.0|-0.7|0.03||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Pain||0.03|-0.70|0.0755
74023132|NCT01552057|147599146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.0232|TWO_SIDED|95.0|-0.88|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain||-0.06|-0.88|0.0232
74023133|NCT01552057|147599147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0126|TWO_SIDED|95.0|-0.99|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain||-0.12|-0.99|0.0126
74023134|NCT01552057|147599147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0092|TWO_SIDED|95.0|-0.87|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Least Pain||-0.12|-0.87|0.0092
73847563|NCT01374425|147240813|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-4.4|||||TWO_SIDED|95.0|-9.5|0.6|||||The difference was calculated as the percentage of participants with resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||0.6|-9.5|
73847564|NCT01374425|147240814|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-1.6|||||TWO_SIDED|95.0|-6.2|3.1|||||The difference was calculated as the percentage of participants with complete resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||3.1|-6.2|
73847565|NCT01374425|147240815|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0593|TWO_SIDED|95.0|0.99|1.69||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.69|0.99|0.0593
73847566|NCT01374425|147240816|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.002|TWO_SIDED|95.0|1.2|2.24||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||2.24|1.20|0.0020
73847567|NCT01374425|147240817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.0955|TWO_SIDED|95.0|0.95|1.88||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.88|0.95|0.0955
73847568|NCT01374425|147240818|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-5.9|||||TWO_SIDED|95.0|-15.7|3.8|||||The difference was calculated as the percentage of participants with objective response in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||3.8|-15.7|
74023135|NCT01552057|147599147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0083|TWO_SIDED|95.0|-1.0|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Pain Right Now||-0.15|-1.00|0.0083
74023136|NCT01552057|147599147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0807|TWO_SIDED|95.0|-0.98|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With General Activity||0.06|-0.98|0.0807
74023137|NCT01552057|147599147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0057|TWO_SIDED|95.0|-1.29|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Mood||-0.22|-1.29|0.0057
74023138|NCT01552057|147599147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.1114|TWO_SIDED|95.0|-0.84|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Walking Ability||0.09|-0.84|0.1114
74023139|NCT01552057|147599147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1081|TWO_SIDED|95.0|-0.94|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Normal Work||0.09|-0.94|0.1081
74023140|NCT01552057|147599147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0264|TWO_SIDED|95.0|-1.04|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Relationships With Other People||-0.07|-1.04|0.0264
73847569|NCT01374425|147240819|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-5.4|||||TWO_SIDED|95.0|-16.0|5.2|||||The difference was calculated as the percentage of participants with objective response in the KRAS Mutant subgroup minus the KRAS Wild-Type subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||5.2|-16.0|
73847570|NCT01374425|147240820|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-1.1|||||TWO_SIDED|95.0|-6.5|4.3|||||The difference was calculated as the percentage of participants with disease control in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||4.3|-6.5|
73847571|NCT01374425|147240821|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-3.2|||||TWO_SIDED|95.0|-8.6|2.1|||||The difference was calculated as the percentage of participants with resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||2.1|-8.6|
73847572|NCT01374425|147240822|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-4.9|||||TWO_SIDED|95.0|-9.6|-0.2|||||The difference was calculated as the percentage of participants with complete resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||-0.2|-9.6|
73847573|NCT00587041|147240846|SUPERIORITY_OR_OTHER|||||||0.3|||||||Kruskal-Wallis|||80% power for 0.66 DG difference from placebo. The reported value is the overall p-value for CaOx supersaturation by Kruskal-Wallis test of equal change across all three groups, no pair-wise comparison.||||0.3
73847574|NCT00587041|147240846|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||t-test, 1 sided|||Ranked sum T-test for placebo group CaOx SS comparison between 0 and 6 weeks||||0.045
74023141|NCT01552057|147599147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.3959|TWO_SIDED|95.0|-0.81|0.32||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Sleep||0.32|-0.81|0.3959
73847575|NCT00587041|147240846|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||t-test, 1 sided|||Ranked sum T-test for AKSB group CaOX SS comparison between 0 and 6 weeks||||0.67
73847576|NCT00587041|147240846|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 1 sided|||Ranked-sum T-Test for Oxadrop group CaOX SS comparison between 0 and 6 weeks||||0.30
73847577|NCT01419119|147240848|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73847578|NCT01419119|147240849|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73847579|NCT02742129|147240852|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.2||||0.265|TWO_SIDED|95.0|-0.56|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.16|-0.56|0.2650
73899537|NCT02047318|147330429|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in GGT levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-56.7|STANDARD_DEVIATION|356.88||0.7133|TWO_SIDED|95.0|-431.2|317.9||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in GGT levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||317.9|-431.2|0.7133
73899538|NCT02047318|147330430|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|0.16|STANDARD_DEVIATION|2.348||0.7839|TWO_SIDED|95.0|-1.05|1.37||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in total bilirubin levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||1.37|-1.05|0.7839
73899539|NCT02047318|147330430|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-0.15|STANDARD_DEVIATION|0.982||0.5298|TWO_SIDED|95.0|-0.66|0.35||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in direct bilirubin levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||0.35|-0.66|0.5298
73960148|NCT00880048|147455839|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0107|TWO_SIDED|95.0|-0.48|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.06|-0.48|0.0107
73960149|NCT00880048|147455839|SUPERIORITY||Mean Difference (Net)|-0.25||||0.0603|TWO_SIDED|95.0|-0.51|0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.01|-0.51|0.0603
73960150|NCT00880048|147455839|SUPERIORITY||Mean Difference (Net)|-0.2||||0.1458|TWO_SIDED|95.0|-0.46|0.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.07|-0.46|0.1458
74023142|NCT01552057|147599147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0119|TWO_SIDED|95.0|-1.18|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Enjoyment of Life||-0.15|-1.18|0.0119
74023143|NCT01552057|147599147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.0222|TWO_SIDED|95.0|-0.96|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Interference||-0.07|-0.96|0.0222
74023144|NCT01552057|147599148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0113|TWO_SIDED|95.0|-0.71|-0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.09|-0.71|0.0113
74023145|NCT01552057|147599149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.0005|TWO_SIDED|95.0|-0.94|-0.27||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.27|-0.94|0.0005
74023146|NCT01552057|147599150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.37||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.37|-1.07|<0.0001
74023147|NCT01552057|147599151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0226|TWO_SIDED|95.0|-0.82|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.06|-0.82|0.0226
74084396|NCT02102932|147721996|SUPERIORITY_OR_OTHER||Ratio of the geometric means|106.32|STANDARD_DEVIATION|15.7||0.0008|TWO_SIDED|90.0|98.39|114.88||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||114.88|98.39|0.0008
74084397|NCT02102932|147721996|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.44|STANDARD_DEVIATION|15.7||0.0003|TWO_SIDED|90.0|96.68|112.82||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.82|96.68|0.0003
74084398|NCT02102932|147721996|SUPERIORITY_OR_OTHER||Ratio of the geometric means|96.61|STANDARD_DEVIATION|16.9||0.0004|TWO_SIDED|90.0|88.9|104.99||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||104.99|88.90|0.0004
74084399|NCT02102932|147721997|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.16|STANDARD_DEVIATION|6.2||0|TWO_SIDED|90.0|101.97|108.45||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.45|101.97|0.0000
74084400|NCT02102932|147721997|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.07|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|99.75|106.5||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.50|99.75|0.0000
74084401|NCT02102932|147721997|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.14|STANDARD_DEVIATION|7.5||0|TWO_SIDED|90.0|99.37|107.04||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||107.04|99.37|0.0000
74084402|NCT02102932|147721997|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.61|STANDARD_DEVIATION|7.0||0|TWO_SIDED|90.0|99.1|106.25||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.25|99.10|0.0000
74084403|NCT02102932|147721998|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.33|STANDARD_DEVIATION|11.9||0|TWO_SIDED|90.0|99.34|111.68||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||111.68|99.34|0.0000
73847580|NCT02742129|147240853|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis|Mean Difference (Final Values)|-14.68||||0.9069|TWO_SIDED|95.0|-263.65|234.29|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data||234.29|-263.65|0.9069
73847581|NCT02742129|147240854|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.05||||0.9338|TWO_SIDED|95.0|-1.16|1.27|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||1.27|-1.16|0.9338
73960151|NCT00880048|147455839|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0941|TWO_SIDED|95.0|-0.58|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.05|-0.58|0.0941
73847582|NCT02742129|147240855|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.29||||0.8151|TWO_SIDED|95.0|-2.79|2.2|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||2.20|-2.79|0.8151
73847583|NCT02742129|147240856|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.82||||0.4658|TWO_SIDED|95.0|-1.41|3.05|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||3.05|-1.41|0.4658
73847584|NCT02742129|147240857|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|1.06||||0.3902|TWO_SIDED|95.0|-1.37|3.49|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||3.49|-1.37|0.3902
73847585|NCT02742129|147240858|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|10.69||||0.7404|TWO_SIDED|95.0|-53.21|74.6|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||74.6|-53.21|0.7404
73847586|NCT02742129|147240859|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Median Difference (Final Values)|0.05||||0.4282|TWO_SIDED|95.0|-0.08|0.18|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.18|-0.08|0.4282
73847587|NCT02742129|147240861|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.49||||0.1067|TWO_SIDED|95.0|-1.08|0.11|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.11|-1.08|0.1067
73847588|NCT02742129|147240862|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.1||||0.4411|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.16|-0.37|0.4411
73847589|NCT02629861|147240863|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
73847590|NCT02629861|147240863|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
73899540|NCT02047318|147330431|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-0.53|STANDARD_DEVIATION|5.505||0.8218|TWO_SIDED|95.0|-6.31|5.24||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in total bilirubin levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||5.24|-6.31|0.8218
73960152|NCT00880048|147455839|SUPERIORITY||Mean Difference (Net)|-0.27||||0.088|TWO_SIDED|95.0|-0.59|0.04|||Mixed Models Repeated Measures||Placebo vs GW823296 60mg: Week 4|||0.04|-0.59|0.0880
74084404|NCT02102932|147721998|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.75|STANDARD_DEVIATION|13.2||0.0001|TWO_SIDED|90.0|99.09|112.85||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.85|99.09|0.0001
74084405|NCT02102932|147721998|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.9|STANDARD_DEVIATION|11.7||0|TWO_SIDED|90.0|97.11|109.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||109.03|97.11|0.0000
74088255|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.11|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.11|<.0001
74023148|NCT01552057|147599152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.0408|TWO_SIDED|95.0|-0.74|-0.02||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||||-0.02|-0.74|0.0408
73899541|NCT02047318|147330431|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-0.52|STANDARD_DEVIATION|2.001||0.5549|TWO_SIDED|95.0|-2.62|1.58||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in direct bilirubin levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||1.58|-2.62|0.5549
73899542|NCT02108262|147330455|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|1.0|||=|0.1241|TWO_SIDED|95.0|-0.1|2.5|||Newcombe-Wilson score method|||||2.5|-0.1|= 0.1241
73899543|NCT02108262|147330455|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|0.5|||=|0.4994|TWO_SIDED|95.0|-0.5|1.7|||Newcombe-Wilson score method|||||1.7|-0.5|= 0.4994
73899544|NCT02108262|147330456|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|-0.2|||=|0.4988|TWO_SIDED|95.0|-1.4|0.7|||Newcombe-Wilson score method|||||0.7|-1.4|= 0.4988
73899545|NCT02108262|147330456|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|0.5|||=|0.6241|TWO_SIDED|95.0|-0.7|1.9|||Newcombe-Wilson score method|||||1.9|-0.7|= 0.6241
73899546|NCT02108262|147330457|OTHER||Hazard Ratio (HR)|1.18|||=|0.5733|TWO_SIDED|95.0|0.67|2.05||Stratified log-rank p-value|Log Rank|||||2.05|0.67|= 0.5733
73899547|NCT02108262|147330457|OTHER||Hazard Ratio (HR)|1.02|||=|0.9717|TWO_SIDED|95.0|0.57|1.8||Stratified log-rank p-value|Log Rank|||||1.80|0.57|= 0.9717
73899548|NCT01895361|147330518|OTHER||Hodges-Lehmann median absolute diff.|-1.01|||=|0.01|TWO_SIDED|95.0|-2.0|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crisis history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|-2.00|= 0.010
73899549|NCT01895361|147330518|OTHER||Hodges-Lehmann median absolute diff.|-0.69|||=|0.18|TWO_SIDED|95.0|-1.84|0.02|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.02|-1.84|= 0.180
73899550|NCT01895361|147330519|OTHER||Change vs placebo (%)|-45.3|||||ONE_SIDED|||||||||||||
73899551|NCT01895361|147330519|OTHER||Change vs placebo (%)|-32.6|||||ONE_SIDED|||||||||||||
73899552|NCT01895361|147330520|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.45|TWO_SIDED|95.0|-4.36|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|-4.36|= 0.450
73899553|NCT01895361|147330520|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.837|TWO_SIDED|95.0|-3.9|2.61|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||2.61|-3.90|= 0.837
73899554|NCT01895361|147330521|OTHER||Hazard Ratio (HR)|0.495|||=|0.001|TWO_SIDED|95.0|0.331|0.741|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||0.741|0.331|= 0.001
73899555|NCT01895361|147330521|OTHER||Hazard Ratio (HR)|0.752|||=|0.136|TWO_SIDED|95.0|0.515|1.097|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||1.097|0.515|= 0.136
73899556|NCT01895361|147330522|OTHER||Hazard Ratio (HR)|0.534|||=|0.022|TWO_SIDED|95.0|0.329|0.866|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||0.866|0.329|= 0.022
73899557|NCT01895361|147330522|OTHER||Hazard Ratio (HR)|0.693|||=|0.1|TWO_SIDED|95.0|0.44|1.092|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||1.092|0.440|= 0.100
73899558|NCT01895361|147330523|OTHER||Hodges-Lehmann median absolute diff.|-1.0|||=|0.015|TWO_SIDED|95.0|-1.98|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|-1.98|= 0.015
73899559|NCT01895361|147330523|OTHER||Hodges-Lehmann median absolute diff.|-0.87|||=|0.12|TWO_SIDED|95.0|-1.77|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|-1.77|= 0.120
74023149|NCT03193866|147599161|SUPERIORITY||Difference in proportion|1.5|||||TWO_SIDED|95.0|-1.8|4.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.9|-1.8|
73899560|NCT01895361|147330524|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.78|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|0.00|= 0.780
73899561|NCT01895361|147330524|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.868|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|0.00|= 0.868
73899562|NCT01903252|147330564|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority, pre-defined non-inferiority margin 10% A two-sided 95% confidence interval about the difference in proportions was constructed. If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.|Risk Difference (RD)|-2.2||||0.005|TWO_SIDED|95.0|-8.1|3.8|||Non-inferiority|||If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.||3.8|-8.1|0.005
73899563|NCT01903252|147330565|SUPERIORITY_OR_OTHER||Percentag|75.3|||||TWO_SIDED|95.0|69.4|80.6||||||||80.6|69.4|
73899564|NCT01903252|147330567|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority|Risk Difference (RD)|-2.1|||<|0.001|TWO_SIDED|95.0|-6.5|2.2|||Non-inferiority|||||2.2|-6.5|<0.001
73899565|NCT01903252|147330568|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.1||||0.026|TWO_SIDED|95.0|-10.1|3.9|||Non-inferiority|||||3.9|-10.1|0.026
73899566|NCT01903252|147330569|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-4.8||||0.048|TWO_SIDED|95.0|-10.9|1.4|||Non-inferiority|||||1.4|-10.9|0.048
73899567|NCT01903252|147330570|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority|Risk Difference (RD)|-3.9||||0.042|TWO_SIDED|95.0|-10.8|3.1|||Non-inferiortiy|||||3.1|-10.8|0.042
74023150|NCT03193866|147599161|SUPERIORITY||Difference in proportion|-0.2|||||TWO_SIDED|95.0|-6.8|6.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.5|-6.8|
74023151|NCT03193866|147599161|SUPERIORITY||Difference in proportion|1.3|||||TWO_SIDED|95.0|-1.7|4.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.3|-1.7|
73899568|NCT01903252|147330571|NON_INFERIORITY|Non-Inferiority|Risk Difference (RD)|-4.2||||0.048|TWO_SIDED|95.0|-11.0|2.7|||Non-inferiority|||||2.7|-11.0|0.048
73899569|NCT01903252|147330572|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-5.3||||0.068|TWO_SIDED|95.0|-11.5|0.9|||Non-inferiority|||||0.9|-11.5|0.068
73899570|NCT01903252|147330573|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-2.9||||0.021|TWO_SIDED|95.0|-9.8|4.0|||Non-inferiortiy|||||4.0|-9.8|0.021
74023152|NCT03193866|147599161|SUPERIORITY||Difference in proportion|-0.9|||||TWO_SIDED|95.0|-4.3|2.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.4|-4.3|
74023153|NCT03193866|147599161|SUPERIORITY||Difference in proportion|1.7|||||TWO_SIDED|95.0|-1.3|4.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.6|-1.3|
74023154|NCT03193866|147599161|SUPERIORITY||Difference in proportion|0.3|||||TWO_SIDED|95.0|-2.7|3.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.3|-2.7|
74023155|NCT03193866|147599161|SUPERIORITY||Difference in proportion|1.2|||||TWO_SIDED|95.0|-2.0|4.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.4|-2.0|
74023156|NCT03193866|147599161|SUPERIORITY||Difference in proportion|2.0|||||TWO_SIDED|95.0|-3.2|7.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.1|-3.2|
74023157|NCT03193866|147599162|SUPERIORITY||Difference in proportion|0.7|||||TWO_SIDED|95.0|-7.5|8.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.8|-7.5|
74084406|NCT02102932|147721998|SUPERIORITY_OR_OTHER||Ratio of the geometric means|93.84|STANDARD_DEVIATION|13.6||0.0002|TWO_SIDED|90.0|87.74|100.36||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||100.36|87.74|0.0002
74084407|NCT02250651|147722009|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.41||0.3738|TWO_SIDED|95.0|-1.17|0.44|||MMRM|||Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.44|-1.17|0.3738
74084408|NCT02250651|147722009|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.41||0.8514|TWO_SIDED|95.0|-0.88|0.73|||MMRM|||Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.73|-0.88|0.8514
74084409|NCT02250651|147722009|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0401|TWO_SIDED|95.0|-1.57|-0.04|||MMRM|||Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||-0.04|-1.57|0.0401
74084410|NCT02250651|147722009|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.39||0.3621|TWO_SIDED|95.0|-1.12|0.41|||MMRM|||Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.41|-1.12|0.3621
74084411|NCT02250651|147722010|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.36||0.0382||95.0|-1.48|-0.04|||MMRM|||Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.48|0.0382
73899571|NCT01903252|147330574|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.4||||0.031|TWO_SIDED|95.0|-10.3|3.7|||Non-inferiortiy|||||3.7|-10.3|0.031
73899572|NCT01903252|147330575|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.7||||0.013|TWO_SIDED|95.0|-9.2|1.8|||Non-inferiority|||||1.8|-9.2|0.013
73899573|NCT01903252|147330576|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.9||||0.042|TWO_SIDED|95.0|-10.8|3.0|||Non-inferiority|||||3.0|-10.8|0.042
73960153|NCT00880048|147455839|SUPERIORITY||Mean Difference (Net)|-0.38||||0.0313|TWO_SIDED|95.0|-0.73|-0.03|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||-0.03|-0.73|0.0313
73899574|NCT01903252|147330577|OTHER||Mean Difference (Net)|-0.1||||0.557|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||||0.3|-0.5|0.557
73899575|NCT01903252|147330578|OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.3|0.3|||t-test, 2 sided|||||0.3|-0.3|0.987
73899576|NCT01903252|147330579|OTHER||Mean Difference (Net)|0.1||||0.455|TWO_SIDED|95.0|-0.1|0.2|||t-test, 2 sided||The result of the mean difference is not corresponding to the values in the table due to rounding as specified in the Statistical Analysis Plan (SAP).|||0.2|-0.1|0.455
73899577|NCT01903252|147330580|OTHER||Mean Difference (Net)|0.0||||0.937|TWO_SIDED|95.0|-0.1|0.1|||t-test, 2 sided||The apparent difference between the values in the table and the mean difference is due to rounding as defined in the SAP.|||0.1|-0.1|0.937
73960154|NCT00880048|147455839|SUPERIORITY||Mean Difference (Net)|-0.2||||0.2639|TWO_SIDED|95.0|-0.55|0.15|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.15|-0.55|0.2639
73899578|NCT01903252|147330581|OTHER||Mean Difference (Net)|-0.1||||0.357|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||||0.1|-0.2|0.357
73899579|NCT01903252|147330582|OTHER||Mean Difference (Net)|-0.1||||0.099|TWO_SIDED|95.0|-0.2|0.0|||t-test, 2 sided|||||0.0|-0.2|0.099
73899580|NCT01903252|147330583|OTHER||Percentage|21.8|||||TWO_SIDED|95.0|16.8|27.5||||||||27.5|16.8|
73899581|NCT01903252|147330584|OTHER||Percentage|60.1|||||TWO_SIDED|95.0|53.6|66.3||||||||66.3|53.6|
73899582|NCT01903252|147330585|OTHER||Percentage|26.3|||||TWO_SIDED|95.0|20.9|32.3||||||||32.3|20.9|
73899583|NCT01903252|147330586|OTHER||Percentage|44.9|||||TWO_SIDED|95.0|38.5|51.3||||||||51.3|38.5|
73960155|NCT00880048|147455840|SUPERIORITY||Mean Difference (Net)|-1.57||||0.0421|TWO_SIDED|95.0|-3.08|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||-0.06|-3.08|0.0421
74084412|NCT02250651|147722010|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.36||0.1133||95.0|-1.29|0.14|||MMRM|||Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.14|-1.29|0.1133
73960156|NCT00880048|147455840|SUPERIORITY||Mean Difference (Net)|-0.74||||0.3394|TWO_SIDED|95.0|-2.27|0.78|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||0.78|-2.27|0.3394
74084413|NCT02250651|147722011|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0013||95.0|-1.76|-0.43|||MMRM|||Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.43|-1.76|0.0013
74084414|NCT02250651|147722011|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.34||0.0364||95.0|-1.38|-0.05|||MMRM|||Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.05|-1.38|0.0364
74084415|NCT02250651|147722012|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2304||95.0|-1.22|0.29|||MMRM|||Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.29|-1.22|0.2304
73847591|NCT02629861|147240865|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
73847592|NCT02629861|147240865|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
73847593|NCT02629861|147240865|SUPERIORITY|||||||0.0032||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0032
73847594|NCT02629861|147240865|SUPERIORITY|||||||0.001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0010
73847595|NCT02629861|147240865|SUPERIORITY|||||||0.0048||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0048
73847596|NCT02629861|147240865|SUPERIORITY|||||||0.0003||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0003
73847597|NCT02629861|147240865|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
73847598|NCT02629861|147240865|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
73847599|NCT02629861|147240866|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
73847600|NCT02629861|147240866|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
73847601|NCT02629861|147240867|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
73847602|NCT02629861|147240867|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
73847603|NCT02629861|147240868|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||<0.0001
73847604|NCT02629861|147240868|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||<0.0001
73847605|NCT02629861|147240869|SUPERIORITY|||||||0.0023||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||0.0023
73847606|NCT02629861|147240869|SUPERIORITY|||||||0.0021||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||0.0021
74084416|NCT02250651|147722012|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.1272||95.0|-1.34|0.17|||MMRM|||Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.17|-1.34|0.1272
74084417|NCT02250651|147722013|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.0038||95.0|-1.76|-0.34|||MMRM|||Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.76|0.0038
74084418|NCT02250651|147722013|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.36||0.0741||95.0|-1.36|0.06|||MMRM|||Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.06|-1.36|0.0741
74084419|NCT02250651|147722014|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.41||0.3738||95.0|-1.17|0.44|||MMRM|||Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.44|-1.17|0.3738
73847607|NCT01088906|147240912|SUPERIORITY||Odds Ratio (OR)|34.0||||0.05|TWO_SIDED||||||Regression, Logistic|||||||0.05
73847608|NCT03384875|147240924|SUPERIORITY||Risk Difference (RD)|0.0||||0.517|TWO_SIDED||||||Chi-squared|||||||0.517
73960157|NCT00880048|147455840|SUPERIORITY||Mean Difference (Net)|-1.4||||0.0963|TWO_SIDED|95.0|-3.05|0.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.25|-3.05|0.0963
73960158|NCT00880048|147455840|SUPERIORITY||Mean Difference (Net)|-1.94||||0.0235|TWO_SIDED|95.0|-3.62|-0.26|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||-0.26|-3.62|0.0235
73960159|NCT00880048|147455840|SUPERIORITY||Mean Difference (Net)|-0.77||||0.3956|TWO_SIDED|95.0|-2.54|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||1.01|-2.54|0.3956
73960160|NCT00880048|147455840|SUPERIORITY||Mean Difference (Net)|-0.73||||0.4273|TWO_SIDED|95.0|-2.53|1.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||1.07|-2.53|0.4273
73960161|NCT00880048|147455840|SUPERIORITY||Mean Difference (Net)|-0.94||||0.3429|TWO_SIDED|95.0|-2.89|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||1.01|-2.89|0.3429
73960162|NCT00880048|147455840|SUPERIORITY||Mean Difference (Net)|-1.19||||0.2403|TWO_SIDED|95.0|-3.18|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||0.80|-3.18|0.2403
73960163|NCT00880048|147455841|SUPERIORITY||Mixed effects repeated measures model|22.52||||0.103|TWO_SIDED|95.0|-4.58|49.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, total sleep time||49.61|-4.58|0.1030
73960164|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|33.21||||0.0179|TWO_SIDED|95.0|5.76|60.65|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, total sleep time||60.65|5.76|0.0179
73960165|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|7.62||||0.5773|TWO_SIDED|95.0|-19.25|34.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, total sleep time||34.49|-19.25|0.5773
73960166|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|21.4||||0.125|TWO_SIDED|95.0|-5.97|48.76|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, total sleep time||48.76|-5.97|0.1250
73960167|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|30.87||||0.0344|TWO_SIDED|95.0|2.29|59.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, total sleep time||59.45|2.29|0.0344
73960168|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|36.52||||0.0131|TWO_SIDED|95.0|7.72|65.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, total sleep time||65.32|7.72|0.0131
73960169|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|2.18||||0.8794|TWO_SIDED|95.0|-26.1|30.46|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, total sleep time||30.46|-26.10|0.8794
73960170|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|28.4||||0.0556|TWO_SIDED|95.0|-0.69|57.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, total sleep time||57.50|-0.69|0.0556
73960171|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-23.9||||0.0078|TWO_SIDED|95.0|-41.46|-6.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep onset latency||-6.33|-41.46|0.0078
73960172|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-25.49||||0.0052|TWO_SIDED|95.0|-43.3|-7.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep onset latency||-7.68|-43.30|0.0052
73960173|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-12.45||||0.2373|TWO_SIDED|95.0|-33.14|8.24|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep onset latency||8.24|-33.14|0.2373
73960174|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|1.75||||0.8707|TWO_SIDED|95.0|-19.38|22.87|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep onset latency||22.87|-19.38|0.8707
73960175|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-12.92||||0.1933|TWO_SIDED|95.0|-32.43|6.59|||Mixed Models Repeated Measures|||Placebo va GW823296 30 mg: Week 4, sleep onset latency||6.59|-32.43|0.1933
74023158|NCT03193866|147599162|SUPERIORITY||Difference in proportion|-2.9|||||TWO_SIDED|95.0|-18.5|12.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||12.8|-18.5|
74023159|NCT03193866|147599162|SUPERIORITY||Difference in proportion|-0.1|||||TWO_SIDED|95.0|-8.8|8.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.6|-8.8|
74023160|NCT03193866|147599162|SUPERIORITY||Difference in proportion|-0.5|||||TWO_SIDED|95.0|-8.1|7.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.2|-8.1|
74023161|NCT03193866|147599162|SUPERIORITY||Difference in proportion|1.6|||||TWO_SIDED|95.0|-5.7|8.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.9|-5.7|
74023162|NCT03193866|147599162|SUPERIORITY||Difference in proportion|1.6|||||TWO_SIDED|95.0|-4.7|8.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.0|-4.7|
74023163|NCT03193866|147599162|SUPERIORITY||Difference in proportion|0.9|||||TWO_SIDED|95.0|-6.2|7.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.9|-6.2|
74023164|NCT03193866|147599162|SUPERIORITY||Difference in proportion|-1.6|||||TWO_SIDED|95.0|-10.8|7.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.5|-10.8|
74023165|NCT03193866|147599163|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-2.5|3.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.3|-2.5|
74023166|NCT03193866|147599163|SUPERIORITY||Mean Difference (Net)|-4.5|||||TWO_SIDED|95.0|-12.5|3.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.4|-12.5|
74084420|NCT02250651|147722014|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.41||0.8514||95.0|-0.88|0.73|||MMRM|||Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.73|-0.88|0.8514
74084421|NCT02250651|147722015|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0401||95.0|-1.57|-0.04|||MMRM|||Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.57|0.0401
74023167|NCT03193866|147599163|SUPERIORITY||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-2.5|1.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.8|-2.5|
74023168|NCT03193866|147599163|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-4.9|-0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.1|-4.9|
74023169|NCT03193866|147599163|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-2.6|1.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.1|-2.6|
74023170|NCT03193866|147599163|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-4.2|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-4.2|
74023171|NCT03193866|147599163|SUPERIORITY||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-4.0|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-4.0|
74084422|NCT02250651|147722015|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.39||0.3621|TWO_SIDED|95.0|-1.12|0.41|||MMRM|||Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.41|-1.12|0.3621
74084423|NCT02250651|147722016|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.36||0.0382|TWO_SIDED|95.0|-1.48|-0.04|||MMRM|||Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.48|0.0382
74084424|NCT02250651|147722016|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.36||0.1133|TWO_SIDED|95.0|-1.29|0.14|||MMRM|||Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.14|-1.29|0.1133
74084425|NCT02250651|147722016|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0013|TWO_SIDED|95.0|-1.76|-0.43|||MMRM|||Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.43|-1.76|0.0013
74084426|NCT02250651|147722016|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.34||0.0364|TWO_SIDED|95.0|-1.38|-0.05|||MMRM|||Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.05|-1.38|0.0364
74084427|NCT02250651|147722016|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2304|TWO_SIDED|95.0|-1.22|0.29|||MMRM|||Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.29|-1.22|0.2304
74088256|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.23|-0.51|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.23|<.0001
73847609|NCT03257358|147240945|OTHER|Estimation|least squares mean|-413.4|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-422.7||||ANCOVA|||||-404.|-422.7|
73847610|NCT03257358|147240945|OTHER|Estimation|least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-3.9|3.6|||ANCOVA|||||3.6|-3.9|
74023172|NCT03193866|147599163|SUPERIORITY||Mean Difference (Net)|2.6|||||TWO_SIDED|95.0|-0.6|5.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.8|-0.6|
73960176|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-10.55||||0.2933|TWO_SIDED|95.0|-30.26|9.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep onset latency||9.17|-30.26|0.2933
73960177|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-28.58||||0.0177|TWO_SIDED|95.0|-52.15|-5.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep onset latency||-5.01|-52.15|0.0177
73960178|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-30.07||||0.0152|TWO_SIDED|95.0|-54.29|-5.84|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep onset latency||-5.84|-54.29|0.0152
73960179|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-17.19||||0.0108|TWO_SIDED|95.0|-30.36|-4.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, wake time after sleep onset||-4.01|-30.36|0.0108
74023173|NCT03193866|147599164|SUPERIORITY||Mean Difference (Net)|2.3|||||TWO_SIDED|95.0|-2.2|6.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.8|-2.2|
74023174|NCT03193866|147599164|SUPERIORITY||Mean Difference (Net)|-8.3|||||TWO_SIDED|95.0|-20.3|3.7||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.7|-20.3|
73847611|NCT03257358|147240946|OTHER|Estimation|least squares mean|-368.7|STANDARD_ERROR_OF_MEAN|7.08|||TWO_SIDED|95.0|-382.8|354.7|||ANCOVA|||||354.7|-382.8|
73847612|NCT03257358|147240946|OTHER|Estimation|least squares mean|-0.1|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-7.1|6.9|||ANCOVA|||||6.9|-7.1|
73847613|NCT03257358|147240947|OTHER|Estimation|least squares mean|-52.1|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|95.0|-57.2|-46.9|||ANCOVA|||||-46.9|-57.2|
73847614|NCT03257358|147240947|OTHER|Estimation|least squares mean|-3.1|STANDARD_ERROR_OF_MEAN|2.27|||TWO_SIDED|95.0|-7.6|1.4|||ANCOVA|||||1.4|-7.6|
73847615|NCT03257358|147240948|OTHER|Estimation|least squares mean|-43.6|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|-46.9|-40.3|||ANCOVA|||||-40.3|-46.9|
73847616|NCT03257358|147240948|OTHER|Estimation|least squares mean|-0.7|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|-3.0|1.7|||ANCOVA|||||1.7|-3.0|
73847617|NCT03257358|147240949|OTHER|Estimation|least squares mean|-36.3|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-37.2|-35.3|||ANCOVA|||||-35.3|-37.2|
73847618|NCT03257358|147240949|OTHER|Estimation|least squares mean|0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|||||1.2|-0.4|
73847619|NCT03257358|147240950|OTHER|Estimation|least squares mean|-53.2|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|95.0|-55.1|-51.3|||ANCOVA|||||-51.3|-55.1|
73847620|NCT03257358|147240950|OTHER|Estimation|least squares mean|0.4|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.7|1.4|||ANCOVA|||||1.4|-0.7|
73847621|NCT03257358|147240951|OTHER|Estimation|least squares mean|-140.4|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-145.8|-135.0|||ANCOVA|||||-135.0|-145.8|
73847622|NCT03257358|147240951|OTHER|Estimation|least squares mean|0.7|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-1.9|3.3|||ANCOVA|||||3.3|-1.9|
73847623|NCT03257358|147240952|OTHER|Estimation|least squares mean|-85.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|-89.0|-81.4|||ANCOVA|||||-81.4|-89.0|
73847624|NCT03257358|147240952|OTHER|Estimation|least squares mean|0.2|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-2.3|1.9|||ANCOVA|||||1.9|-2.3|
73847625|NCT03257358|147240953|OTHER|Estimation|least squares mean|-27.9|STANDARD_ERROR_OF_MEAN|11.65|||TWO_SIDED|95.0|-51.1|-4.8|||ANCOVA|||||-4.8|-51.1|
73847626|NCT03257358|147240953|OTHER|Estimation|least squares mean|-9.4|STANDARD_ERROR_OF_MEAN|3.47|||TWO_SIDED|95.0|-16.3|-2.6|||ANCOVA|||||-2.6|-16.3|
73847627|NCT03257358|147240954|OTHER|Estimation|least squares mean|-181.2|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-183.3|-179.0|||ANCOVA|||||-179.0|-183.3|
73847628|NCT03257358|147240954|OTHER|Estimation|least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-4.1|2.5|||ANCOVA|||||2.5|-4.1|
73847629|NCT03257358|147240955|OTHER|Estimation|least squares mean|-55.2|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-56.5|-53.9|||ANCOVA|||||-53.9|-56.5|
73847630|NCT03257358|147240955|OTHER|Estimation|least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||||1.1|-0.5|
73847631|NCT03257358|147240956|OTHER|Estimation|least squares mean|-7.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-8.0|-6.4|||ANCOVA|||||-6.4|-8.0|
73847632|NCT03257358|147240956|OTHER|Estimation|least squares mean|1.1|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|0.3|2.0|||ANCOVA|||||2.0|0.3|
73847633|NCT03257358|147240957|OTHER|Estimation|least squares mean|69.4|STANDARD_ERROR_OF_MEAN|13.78|||TWO_SIDED|95.0|42.1|96.7|||ANCOVA|||||96.7|42.1|
73847634|NCT03257358|147240957|OTHER|Estimation|least squares mean|117.0|STANDARD_ERROR_OF_MEAN|10.07|||TWO_SIDED|95.0|97.1|136.9|||ANCOVA|||||136.9|97.1|
73847635|NCT03257358|147240958|OTHER|Estimation|least squares mean|-782.6|STANDARD_ERROR_OF_MEAN|138.9|||TWO_SIDED|95.0|-1058.2|-507.1|||ANCOVA|||||-507.1|-1058.2|
73847636|NCT03257358|147240958|OTHER|Estimation|least squares mean|-485.9|STANDARD_ERROR_OF_MEAN|91.88|||TWO_SIDED|95.0|-667.3|-304.4|||ANCOVA|||||-304.4|-667.3|
73847637|NCT03257358|147240959|OTHER|Estimation|least squares mean|-33.3|STANDARD_ERROR_OF_MEAN|7.47|||TWO_SIDED|95.0|-48.2|-18.5|||ANCOVA|||||-18.5|-48.2|
73847638|NCT03257358|147240959|OTHER|Estimation|least squares mean|-25.8|STANDARD_ERROR_OF_MEAN|5.52|||TWO_SIDED|95.0|-36.7|-14.9|||ANCOVA|||||-14.9|-36.7|
74023175|NCT03193866|147599164|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-2.6|3.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.5|-2.6|
74023176|NCT03193866|147599164|SUPERIORITY||Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-5.8|0.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.9|-5.8|
74023177|NCT03193866|147599164|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-2.9|2.7||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.7|-2.9|
74023178|NCT03193866|147599164|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-4.5|1.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.6|-4.5|
74023179|NCT03193866|147599164|SUPERIORITY||Mean Difference (Net)|-1.6|||||TWO_SIDED|95.0|-4.7|1.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.5|-4.7|
74023180|NCT03193866|147599164|SUPERIORITY||Mean Difference (Net)|2.3|||||TWO_SIDED|95.0|-1.7|6.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.4|-1.7|
74023181|NCT03193866|147599165|SUPERIORITY||Difference in proportion|0.39|||||TWO_SIDED|95.0|0.3|0.48||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.48|0.30|
74023182|NCT03193866|147599165|SUPERIORITY||Difference in proportion|0.27|||||TWO_SIDED|95.0|0.11|0.42||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.42|0.11|
74023183|NCT03193866|147599165|SUPERIORITY||Difference in proportion|0.17|||||TWO_SIDED|95.0|0.1|0.23||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.23|0.10|
74023184|NCT03193866|147599165|SUPERIORITY||Difference in proportion|0.05|||||TWO_SIDED|95.0|-0.03|0.13||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.13|-0.03|
74084428|NCT02250651|147722016|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.1272|TWO_SIDED|95.0|-1.34|0.17|||MMRM|||Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.17|-1.34|0.1272
73847639|NCT03257358|147240960|OTHER|Estimation|least squares mean|-888.7|STANDARD_ERROR_OF_MEAN|13.1|||TWO_SIDED|95.0|-914.6|-862.7|||ANCOVA|||||-862.7|-914.6|
73847640|NCT03257358|147240960|OTHER|Estimation|least squares mean|-3.3|STANDARD_ERROR_OF_MEAN|7.24|||TWO_SIDED|95.0|-17.6|11.0|||ANCOVA|||||11.0|-17.6|
73847641|NCT03257358|147240961|OTHER|Estimation|least squares mean|-39.5|STANDARD_ERROR_OF_MEAN|1.053|||TWO_SIDED|95.0|-41.59|-37.42|||ANCOVA|||||-37.42|-41.59|
74084429|NCT02250651|147722016|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.0038|TWO_SIDED|95.0|-1.76|-0.34|||MMRM|||Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.76|0.0038
74084430|NCT02250651|147722016|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.36||0.0741|TWO_SIDED|95.0|-1.36|0.06|||MMRM|||Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.06|-1.36|0.0741
74084431|NCT03496298|147722017|NON_INFERIORITY|Non-inferiority of efpeglenatide 4 mg+6 mg versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio for the incidence of both 1.8 and less and 1.3 or less.|Hazard Ratio (HR)|0.732|||<|0.0001|TWO_SIDED|95.0|0.583|0.918||One-sided p-value based on log rank test of hazard ratio for the incidence of both 1.8 and less and 1.3 or less.|Log Rank|||Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.918|0.583|<.0001
74084432|NCT03496298|147722018|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.732||||0.0069|TWO_SIDED|95.0|0.583|0.918||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.918|0.583|0.0069
74084433|NCT03496298|147722019|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.79||||0.02|TWO_SIDED|95.0|0.65|0.96||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.96|0.65|0.02
74084434|NCT03496298|147722020|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.675|||<|0.0001|TWO_SIDED|95.0|0.574|0.794||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.794|0.574|<.0001
74084435|NCT01658995|147722021|SUPERIORITY||Risk Difference (RD)|-9.9||||0.37|TWO_SIDED|95.0|-31.4|11.6|||Chi-squared|||||11.6|-31.4|0.37
74084436|NCT01658995|147722022|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
74084437|NCT02522780|147722034|SUPERIORITY||Odds Ratio (OR)|1.57|||>|0.05|TWO_SIDED|95.0|0.96|2.54||The p-value was based on Cochran-Mantel-Haenszel test by controlling pathway of randomization, at a 0.05 significance level.|Cochran-Mantel-Haenszel|||Proportions were compared between treatment groups at Month 6.||2.54|0.96|>0.05
74084438|NCT02522780|147722035|SUPERIORITY||Odds Ratio (OR)|1.24|||>|0.05|TWO_SIDED|95.0|0.76|2.03||The p-value was based on Generalized estimating equations (GEE) approach with binary outcomes (clinical remission) and an unstructured working correlation matrix, at a 0.05 significance level.|Generalised estimating equation approach|||Proportions were compared between treatment groups over 6 months.||2.03|0.76|>0.05
74084439|NCT02522780|147722036|SUPERIORITY||Hazard Ratio (HR)|0.6|||>|0.05|TWO_SIDED|95.0|0.25|1.44||The p-value was based on log-rank test using pathway of randomization as the stratification factor, at a 0.05 significance level.|Log Rank|||Times to relapse were compared between treatment groups up to 6 months.||1.44|0.25|>0.05
74084440|NCT02522780|147722037|SUPERIORITY||Odds Ratio (OR)|0.39|||<|0.05|TWO_SIDED|95.0|0.19|0.79||The p-value was based on Cochran-Mantel-Haenszel test by controlling pathway of randomization, at a 0.05 significance level.|Cochran-Mantel-Haenszel|||Proportions were compared between treatment groups at Month 6.||0.79|0.19|<0.05
74084441|NCT02522780|147722038|SUPERIORITY||Mean difference|-1.0|||>|0.05|TWO_SIDED|95.0|-2.7|0.7||The p-value was based on a repeated-measures analysis of covariance (ANCOVA) model with an unstructured correlation matrix , at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in CRP levels over 6 months was reported.||0.7|-2.7|>0.05
74084442|NCT02522780|147722039|SUPERIORITY||Mean difference|-66.92|||>|0.05|TWO_SIDED|95.0|-140.2|6.36||The p-value was based on a repeated-measures ANCOVA model with an unstructured correlation matrix, at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in fecal calprotectin levels over 6 months was reported.||6.36|-140.2|>0.05
73960180|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-16.15||||0.019|TWO_SIDED|95.0|-29.61|-2.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, wake time after sleep onset||-2.68|-29.61|0.0190
74084443|NCT02522780|147722040|SUPERIORITY||Mean difference|-0.32|||>|0.05|TWO_SIDED|95.0|-4.41|3.77||The p-value was based on a repeated-measures ANCOVA model with an unstructured correlation matrix, at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in IBDQ total scores over 6 months was reported.||3.77|-4.41|>0.05
73899584|NCT01903252|147330587|OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
73899585|NCT03039621|147330636|SUPERIORITY|||||||0.026||||||a priori threshold for statistical significance equals 0.05|Wilcoxon (Mann-Whitney)|||||||0.026
73899586|NCT03039621|147330637|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
73899587|NCT03039621|147330638|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
73899588|NCT03039621|147330639|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
73899589|NCT03039621|147330640|SUPERIORITY|||||||0.0201||||||"The p-value associated with treatment factor of total severity index of the disease from Day 2 to Day 3, 4, 5 and 6 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0201
73960181|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|1.89||||0.8195|TWO_SIDED|95.0|-14.43|18.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, wake time after sleep onset||18.21|-14.43|0.8195
73960182|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|5.27||||0.5327|TWO_SIDED|95.0|-11.35|21.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, wake time after sleep onset||21.89|-11.35|0.5327
73960183|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-2.5||||0.7387|TWO_SIDED|95.0|-17.24|12.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, wake time after sleep onset||12.25|-17.24|0.7387
73960184|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-9.44||||0.2134|TWO_SIDED|95.0|-24.35|5.48|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, wake time after sleep onset||5.48|-24.35|0.2134
73960185|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-14.51||||0.1561|TWO_SIDED|95.0|-34.61|5.6|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, wake time after sleep onset||5.60|-34.61|0.1561
73960186|NCT00880048|147455841|SUPERIORITY||Mean Difference (Net)|-17.1||||0.1054|TWO_SIDED|95.0|-37.84|3.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, wake time after sleep onset||3.64|-37.84|0.1054
73960187|NCT00880048|147455842|SUPERIORITY||Mean Difference (Net)|-0.57||||0.0024|TWO_SIDED|95.0|-0.94|-0.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||-0.21|-0.94|0.0024
73960188|NCT00880048|147455842|SUPERIORITY||Mean Difference (Net)|-0.1||||0.6146|TWO_SIDED|95.0|-0.47|0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||0.28|-0.47|0.6146
73960189|NCT00880048|147455842|SUPERIORITY||Mean Difference (Net)|-0.25||||0.1442|TWO_SIDED|95.0|-0.59|0.09|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.09|-0.59|0.1442
73960190|NCT00880048|147455842|SUPERIORITY||Mean Difference (Net)|0.04||||0.8001|TWO_SIDED|95.0|-0.3|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||0.39|-0.30|0.8001
73960191|NCT00880048|147455842|SUPERIORITY||Mean Difference (Net)|-0.05||||0.8439|TWO_SIDED|95.0|-0.55|0.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||0.45|-0.55|0.8439
73899590|NCT03039621|147330641|SUPERIORITY|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
73899591|NCT03039621|147330642|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||||||0.0025
73899592|NCT03039621|147330642|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.22|||||||Breslow-Day test|||||||0.22
73899593|NCT03039621|147330643|SUPERIORITY|||||||0.0037||||||"The p-value associated with treatment factor of total severity index of the disease from Day 1 to Day 2, 3 and 4 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0037
73899594|NCT03039621|147330644|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
73899595|NCT01879579|147330651|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
73899596|NCT01879579|147330652|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Interval-censoring survival analysis|||||||0.007
73899597|NCT01879579|147330653|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.99
73899598|NCT01879579|147330654|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.78
73899599|NCT01879579|147330655|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.04
73899600|NCT01879579|147330656|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.13
73899601|NCT01879579|147330661|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Generalized estimating equation modeling|||||||0.008
73899602|NCT01879579|147330662|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.003
73899603|NCT02057042|147330708|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73899604|NCT02057042|147330709|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73899605|NCT02057042|147330710|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73899606|NCT02057042|147330711|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73899607|NCT02057042|147330712|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73899608|NCT02057042|147330713|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73899609|NCT02882152|147330726|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"||||<0.05
73960192|NCT00880048|147455842|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1259|TWO_SIDED|95.0|-0.91|0.11|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||0.11|-0.91|0.1259
73960193|NCT00880048|147455842|SUPERIORITY||Mean Difference (Net)|0.2||||0.3709|TWO_SIDED|95.0|-0.24|0.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||0.64|-0.24|0.3709
73960194|NCT00880048|147455842|SUPERIORITY||Mean Difference (Net)|-0.24||||0.2993|TWO_SIDED|95.0|-0.7|0.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||0.22|-0.70|0.2993
73960195|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.59||||0.0344|TWO_SIDED|95.0|0.04|1.14|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep quality||1.14|0.04|0.0344
73960196|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.72||||0.0111|TWO_SIDED|95.0|0.17|1.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep quality||1.27|0.17|0.0111
73960197|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.42||||0.1443|TWO_SIDED|95.0|-0.15|0.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep quality||0.99|-0.15|0.1443
73960198|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.5||||0.0873|TWO_SIDED|95.0|-0.07|1.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep quality||1.08|-0.07|0.0873
73960199|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.73||||0.017|TWO_SIDED|95.0|0.13|1.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, sleep quality||1.33|0.13|0.0170
73960200|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.42||||0.1675|TWO_SIDED|95.0|-0.18|1.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep quality||1.02|-0.18|0.1675
73960201|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.56||||0.0956|TWO_SIDED|95.0|-0.1|1.23|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep quality||1.23|-0.10|0.0956
73960202|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.32||||0.3503|TWO_SIDED|95.0|-0.35|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep quality||1.00|-0.35|0.3503
73960203|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.34||||0.2147|TWO_SIDED|95.0|-0.2|0.88|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, refreshing value of sleep||0.88|-0.20|0.2147
73960204|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.63||||0.0233|TWO_SIDED|95.0|0.09|1.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, refreshing value of sleep||1.17|0.09|0.0233
73960205|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.33||||0.2404|TWO_SIDED|95.0|-0.22|0.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, refreshing value of sleep||0.89|-0.22|0.2404
73960206|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.65||||0.0247|TWO_SIDED|95.0|0.08|1.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, refreshing value of sleep||1.22|0.08|0.0247
73960207|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.69||||0.0271|TWO_SIDED|95.0|0.08|1.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, refreshing value of sleep||1.29|0.08|0.0271
73960208|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.39||||0.2129|TWO_SIDED|95.0|-0.22|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, refreshing value of sleep||1.00|-0.22|0.2129
73847642|NCT03257358|147240961|OTHER|Estimation|least squares mean|0.14|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.87|1.14|||ANCOVA|||||1.14|-0.87|
73960209|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.37||||0.2874|TWO_SIDED|95.0|-0.31|1.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, refreshing value of sleep||1.06|-0.31|0.2874
73960210|NCT00880048|147455843|SUPERIORITY||Mean Difference (Net)|0.71||||0.0472|TWO_SIDED|95.0|0.01|1.41|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, refreshing value of sleep||1.41|0.01|0.0472
73960211|NCT00880048|147455844|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9824|TWO_SIDED|95.0|0.13|7.09|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 1||7.09|0.13|0.9824
73960212|NCT00880048|147455844|SUPERIORITY||Odds Ratio (OR)|0.54||||0.6227|TWO_SIDED|95.0|0.05|6.13|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 1||6.13|0.05|0.6227
73960213|NCT00880048|147455844|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9967|TWO_SIDED|95.0|0.2|5.07|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 2||5.07|0.20|0.9967
73960214|NCT00880048|147455844|SUPERIORITY||Odds Ratio (OR)|2.0||||0.355|TWO_SIDED|95.0|0.46|8.63|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 2||8.63|0.46|0.3550
73960215|NCT00880048|147455844|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1009|TWO_SIDED|95.0|0.85|6.49|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 4||6.49|0.85|0.1009
73960216|NCT00880048|147455844|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0455|TWO_SIDED|95.0|1.02|7.68|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 4||7.68|1.02|0.0455
73960217|NCT00880048|147455844|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0507|TWO_SIDED|95.0|1.0|5.32|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 6||5.32|1.00|0.0507
73960218|NCT00880048|147455844|SUPERIORITY||Odds Ratio (OR)|1.38||||0.4962|TWO_SIDED|95.0|0.55|3.45|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 6||3.45|0.55|0.4962
73847643|NCT03257358|147240962|OTHER|Estimation|least squares mean|-248.9|STANDARD_ERROR_OF_MEAN|15.0|||TWO_SIDED|95.0|-278.7|-219.2|||ANCOVA|||||-219.2|-278.7|
73847644|NCT03257358|147240962|OTHER|Estimation|least squares mean|-9.9|STANDARD_ERROR_OF_MEAN|7.71|||TWO_SIDED|95.0|-25.1|5.4|||ANCOVA|||||5.4|-25.1|
73847645|NCT03257358|147240963|OTHER|Estimation|least squares mean|5.6|STANDARD_ERROR_OF_MEAN|1.249|||TWO_SIDED|95.0|3.13|8.08|||ANCOVA|||||8.08|3.13|
73847646|NCT03257358|147240963|OTHER|Estimation|least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.364|||TWO_SIDED|95.0|-0.68|0.76|||ANCOVA|||||0.76|-0.68|
73847647|NCT03257358|147240964|OTHER|Estimation|least squares mean|-231.0|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|95.0|-234.5|-227.6|||ANCOVA|||||-227.6|-234.5|
73960219|NCT00880048|147455847|SUPERIORITY||Mean Difference (Net)|1.03||||0.3241|TWO_SIDED|95.0|-1.03|3.1|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||3.10|-1.03|0.3241
73960220|NCT00880048|147455847|SUPERIORITY||Mean Difference (Net)|-0.56||||0.602|TWO_SIDED|95.0|-2.66|1.55|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||1.55|-2.66|0.6020
73960221|NCT00880048|147455847|SUPERIORITY||Mean Difference (Net)|2.44||||0.0594|TWO_SIDED|95.0|-0.1|4.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||4.99|-0.10|0.0594
73960222|NCT00880048|147455847|SUPERIORITY||Mean Difference (Net)|0.92||||0.4828|TWO_SIDED|95.0|-1.67|3.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||3.50|-1.67|0.4828
73960223|NCT00880048|147455847|SUPERIORITY||Mean Difference (Net)|0.19||||0.9008|TWO_SIDED|95.0|-2.8|3.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||3.18|-2.80|0.9008
73960224|NCT00880048|147455847|SUPERIORITY||Mean Difference (Net)|-0.71||||0.6428|TWO_SIDED|95.0|-3.74|2.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||2.32|-3.74|0.6428
73960225|NCT00880048|147455847|SUPERIORITY||Mean Difference (Net)|-0.68||||0.6911|TWO_SIDED|95.0|-4.06|2.7|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||2.70|-4.06|0.6911
73960226|NCT00880048|147455847|SUPERIORITY||Odds Ratio (OR)|-0.67||||0.7026|TWO_SIDED|95.0|-4.14|2.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||2.80|-4.14|0.7026
73960227|NCT00880048|147455848|SUPERIORITY||Mean Difference (Net)|-0.97||||0.1301|TWO_SIDED|95.0|-2.24|0.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||0.29|-2.24|0.1301
73960228|NCT00880048|147455848|SUPERIORITY||Mean Difference (Net)|0.47||||0.4644|TWO_SIDED|95.0|-0.79|1.73|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||1.73|-0.79|0.4644
73899610|NCT02882152|147330727|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"||||<0.05
73899611|NCT01437995|147330738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.3|0.69|1.65||||||||1.65|0.69|
73899612|NCT01437995|147330739|SUPERIORITY_OR_OTHER|||||||0.43|||||||Kruskal-Wallis|||||||0.43
73899613|NCT01437995|147330739|SUPERIORITY_OR_OTHER|||||||0.022|||||||Kruskal-Wallis|||||||0.022
73899614|NCT01437995|147330739|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||||||0.002
73899615|NCT01437995|147330740|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.63|1.41||||||||1.41|0.63|
73899616|NCT01437995|147330740|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.8|1.73||||||||1.73|0.80|
73899617|NCT01437995|147330740|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.24|||||TWO_SIDED|95.0|0.83|1.81||||||||1.81|0.83|
73899618|NCT01437995|147330741|SUPERIORITY_OR_OTHER|||||||0.15|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||0.15
73899619|NCT01437995|147330741|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||<0.001
73899620|NCT01437995|147330741|SUPERIORITY_OR_OTHER|||||||0.027|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||0.027
73960229|NCT00880048|147455848|SUPERIORITY||Mean Difference (Net)|-0.76||||0.3382|TWO_SIDED|95.0|-2.33|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.80|-2.33|0.3382
73960230|NCT00880048|147455848|SUPERIORITY||Mean Difference (Net)|0.94||||0.241|TWO_SIDED|95.0|-0.63|2.51|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||2.51|-0.63|0.2410
73960231|NCT00880048|147455848|SUPERIORITY||Mean Difference (Net)|-0.98||||0.2768|TWO_SIDED|95.0|-2.75|0.79|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||0.79|-2.75|0.2768
73960232|NCT00880048|147455848|SUPERIORITY||Mean Difference (Net)|0.06||||0.9434|TWO_SIDED|95.0|-1.7|1.83|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||1.83|-1.70|0.9434
73960233|NCT00880048|147455848|SUPERIORITY||Mean Difference (Net)|-0.55||||0.5796|TWO_SIDED|95.0|-2.49|1.4|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||1.40|-2.49|0.5796
73960234|NCT00880048|147455848|SUPERIORITY||Mean Difference (Net)|0.71||||0.4753|TWO_SIDED|95.0|-1.24|2.66|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||2.66|-1.24|0.4753
73960235|NCT04141917|147455849|SUPERIORITY||Risk Ratio, log|1.33|||||TWO_SIDED|95.0|0.35|5.02||||||The number of influenza-positive tests was analyzed using a generalized linear mixed model following a Poisson distribution with a log link and robust variance. The model is adjusted for calendar time and an exposure time variable based on shelter capacity. This model includes symptomatic individuals who tested throughout Year 1 of the study (November 15, 2019 - March 31, 2020).||5.02|0.35|
73899621|NCT01437995|147330741|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.40
73899622|NCT01437995|147330741|SUPERIORITY_OR_OTHER|||||||0.032|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.032
73899623|NCT01437995|147330741|SUPERIORITY_OR_OTHER|||||||0.21|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.21
73899624|NCT01437995|147330742|SUPERIORITY_OR_OTHER|||||||0.14|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||0.14
73899625|NCT01437995|147330742|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||<0.001
73899626|NCT01437995|147330742|SUPERIORITY_OR_OTHER|||||||0.031|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||0.031
73899627|NCT00159822|147330743|SUPERIORITY_OR_OTHER||Percent of subjects with success|31.7||||||95.0|18.08|48.09|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|For sample size calculation, null hypothesis (p\<p0) is defined as response rate \<15% (ie, weak drug efficacy). Alternative hypothesis (p\>pA) defined as response rate \>30%. To reduce the chance of incorrectly rejecting the null hypothesis to 5% (α=5%) and incorrectly rejecting the alternate hypothesis to 20% (β=20%) it was calculated that a sample size of 48 subjects was required. Null hypothesis was rejected (assessing efficacy of study drug) if the number of eligible success was ≥ than n=12.||48.09|18.08|
73899628|NCT00159822|147330744|SUPERIORITY_OR_OTHER||Percent of subjects with success|33.3||||||95.0|18.6|51.0|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|Month 3 success=yes||51.0|18.6|
73899629|NCT00159822|147330744|SUPERIORITY_OR_OTHER||Percent of subjects with success|43.9||||||95.0|28.5|60.3|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|EOT success=yes||60.3|28.5|
73899630|NCT00159822|147330750|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate overall survival|0.85||||||95.0|0.725|0.976|||||Global survival rate calculated using Kaplan-Meier estimate of overall survival.|||0.976|0.725|
73899631|NCT00329901|147330763|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus(Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|9.0|||||TWO_SIDED|95.0|5.0|14.0||||||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with MenACWY-CRM as compared to Tdap given with placebo saline||14|5|
73960236|NCT02954848|147455857|SUPERIORITY||Median Difference (Final Values)|3.8||||0.0643|TWO_SIDED|95.0|0.0|10.6|||Wilcoxon Rank-Sum Test||The point estimate of the median difference between the treatment groups was calculated using the Hodges-Lehmann estimation.|||10.600|0.000|0.0643
73960237|NCT02954848|147455858|SUPERIORITY|||||||0.0003|||||||Log Rank|||||||0.0003
73960238|NCT02954848|147455859|SUPERIORITY||Median Difference (Final Values)|-0.11||||0.0826|TWO_SIDED|95.0|-0.24|0.01|||Wilcoxon Rank-Sum Test|||||0.0100|-0.2400|0.0826
73960239|NCT02954848|147455860|SUPERIORITY||Median Difference (Final Values)|3.3||||0.0478|TWO_SIDED|95.0|0.0|5.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response||5.300|0.000|0.0478
73960240|NCT02954848|147455860|SUPERIORITY||Median Difference (Final Values)|0.0||||0.8963|TWO_SIDED|95.0|-6.1|6.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response||6.000|-6.100|0.8963
74023185|NCT03193866|147599165|SUPERIORITY||Difference in proportion|0.14|||||TWO_SIDED|95.0|0.08|0.19||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.19|0.08|
74023186|NCT03193866|147599165|SUPERIORITY||Difference in proportion|0.09|||||TWO_SIDED|95.0|0.01|0.16||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.16|0.01|
74023187|NCT03193866|147599165|SUPERIORITY||Difference in proportion|0.14|||||TWO_SIDED|95.0|0.06|0.21||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.21|0.06|
74023188|NCT03193866|147599165|SUPERIORITY||Difference in proportion|0.23|||||TWO_SIDED|95.0|0.13|0.33||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.33|0.13|
74084444|NCT02058160|147722046|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.633|-0.397||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, visits, treatment-by-visit interaction and country as fixed effects and baseline HbA1c value-by-visit interaction as covariates. A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses.||-0.397|-0.633|<0.0001
74084445|NCT02058160|147722047|SUPERIORITY_OR_OTHER||Difference in percentage|25.52|||<|0.0001|TWO_SIDED|95.0|18.94|32.1||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."||32.10|18.94|<0.0001
74084446|NCT02058160|147722047|SUPERIORITY_OR_OTHER||Difference in percentage|19.76|||<|0.0001|TWO_SIDED|95.0|13.9|25.62|||Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."||25.62|13.90|<0.0001
74084447|NCT02058160|147722048|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.43|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|-3.925|-2.939||Threshold for significance at 0.05 level.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening and country as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate.||-2.939|-3.925|<0.0001
74088257|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.19||0.0005|TWO_SIDED|95.0|-1.03|-0.29|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-1.03|0.0005
73847648|NCT03257358|147240964|OTHER|Estimation|least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-5.2|4.5|||ANCOVA|||||4.5|-5.2|
73960241|NCT02954848|147455860|SUPERIORITY||Median Difference (Final Values)|5.2||||0.012|TWO_SIDED|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response||10.700|0.000|0.0120
73847649|NCT03257358|147240965|OTHER|Estimation|least squares mean|-8.3|STANDARD_ERROR_OF_MEAN|0.455|||TWO_SIDED|95.0|-9.21|-7.4|||ANCOVA|||||-7.40|-9.21|
73847650|NCT03257358|147240965|OTHER|Estimation|least squares mean|0.32|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|-0.17|0.82|||ANCOVA|||||0.82|-0.17|
73847651|NCT01977898|147240993|SUPERIORITY|||||||0.877|||||||Fisher Exact|||A sample size of 65 patients in each group would be required to achieve 80% power to detect this difference between intrathecal morphine and saline administration . Sample size of 64 per group achieve 80% power to detect a difference between the group proportions of 0.25. The proportion in the treatment group is assumed to be 0.5 under the null hypothesis and 0.25 under the alternative hypothesis. The proportion in the control group is .05.The significance level of the test was targeted at .05.||||.877
73847652|NCT01977898|147240994|SUPERIORITY|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||.499
73847653|NCT01977898|147240995|SUPERIORITY|||||||0.463|||||||Chi-squared|||||||.463
73847654|NCT01977898|147240996|SUPERIORITY|||||||0.0463|||||||Chi-squared|||||||.0463
73847655|NCT01977898|147240997|SUPERIORITY|||||||0.525|||||||Chi-squared|||||||.525
73847656|NCT01977898|147240998|SUPERIORITY|||||||0.691|||||||Wilcoxon (Mann-Whitney)|||||||0.691
73847657|NCT01977898|147240999|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.610
73847658|NCT01977898|147241000|SUPERIORITY|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||.499
74084448|NCT02058160|147722049|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.224|<|0.0001|TWO_SIDED|95.0|-1.808|-0.93||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline body weight value-by-visit interaction as covariates.||-0.93|-1.808|<0.0001
74084449|NCT02058160|147722050|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|-1.154|-0.64||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline average SMPG value-by-visit interaction as covariates.||-0.64|-1.154|<0.0001
74084450|NCT02058160|147722051|SUPERIORITY_OR_OTHER||difference in percentage|20.82|||<|0.0001|TWO_SIDED|95.0|14.98|26.66||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening.||26.66|14.98|<0.0001
74084451|NCT02058160|147722052|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.766||0.7362|TWO_SIDED|95.0|-1.762|1.246||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline daily insulin glargine dose-by-visit interaction as a covariate.||1.246|-1.762|0.7362
74084452|NCT00926367|147722107|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.||||||>0.05
74084453|NCT00926367|147722109|SUPERIORITY_OR_OTHER||||||>|0.05||||||A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.|Dunn's Multiple Comparisons Test|||||||>0.05
74084454|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.38|0.35||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.35|-0.38|
74084455|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.6|0.13||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.13|-0.60|
74084456|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.7|0.15||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.15|-0.70|
74084457|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.93|-0.07||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.07|-0.93|
74084458|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.69|0.33||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.33|-0.69|
73960242|NCT02954848|147455860|SUPERIORITY||Median Difference (Final Values)|-4.7||||0.0871|TWO_SIDED|95.0|-17.4|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response||0.000|-17.400|0.0871
73960243|NCT02954848|147455861|SUPERIORITY|||||||0.0025|||||||Log Rank|||||||0.0025
74084459|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.09|-0.06||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.06|-1.09|
74084460|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.94|0.27||||||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.27|-0.94|
73847659|NCT01977898|147241001|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
73960244|NCT02954848|147455862|SUPERIORITY|||||||0.1059|||||||Log Rank|||||||0.1059
73960245|NCT02954848|147455863|SUPERIORITY|||||||0.0004|||||||Log Rank|||||||0.0004
73960246|NCT02954848|147455864|SUPERIORITY|||||||0.5393|||||||Log Rank|||||||0.5393
74084461|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.21|0.0||||||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.00|-1.21|
74084462|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.24|-0.03||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.03|-1.24|
73899632|NCT00329901|147330763|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus(Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|1.0|||||TWO_SIDED|95.0|-1.0|2.0||||||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with MenACWY-CRM compared to Tdap given concomitantly with saline placebo||2|-1|
73899633|NCT00329901|147330763|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0||||||Non-inferiority of anti-PT antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||1|-12|
73899634|NCT00329901|147330763|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-3.0|||||TWO_SIDED|95.0|-9.0|3.0||||||Non-inferiority of anti-FHA antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||3|-9|
73960247|NCT02954848|147455865|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.0505|TWO_SIDED|95.0|-0.21|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response||0.0000|-0.2100|0.0505
73960248|NCT02954848|147455865|SUPERIORITY||Median Difference (Final Values)|0.02||||0.8138|TWO_SIDED|95.0|-0.12|0.15|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response||0.1500|-0.1200|0.8138
74023189|NCT03193866|147599166|SUPERIORITY||Difference in proportion|-71.6|||||TWO_SIDED|95.0|-76.6|-66.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-66.6|-76.6|
74023190|NCT03193866|147599166|SUPERIORITY||Difference in proportion|-66.3|||||TWO_SIDED|95.0|-76.3|-56.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-56.4|-76.3|
74023191|NCT03193866|147599166|SUPERIORITY||Difference in proportion|-47.3|||||TWO_SIDED|95.0|-53.0|-41.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-41.7|-53.0|
74023192|NCT03193866|147599166|SUPERIORITY||Difference in proportion|-43.1|||||TWO_SIDED|95.0|-49.6|-36.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-36.6|-49.6|
74023193|NCT03193866|147599166|SUPERIORITY||Difference in proportion|-41.3|||||TWO_SIDED|95.0|-46.4|-36.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-36.2|-46.4|
74023194|NCT03193866|147599166|SUPERIORITY||Difference in proportion|-33.9|||||TWO_SIDED|95.0|-39.8|-28.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-28.0|-39.8|
74023195|NCT03193866|147599166|SUPERIORITY||Difference in proportion|-33.9|||||TWO_SIDED|95.0|-39.7|-28.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-28.0|-39.7|
74023196|NCT03193866|147599166|SUPERIORITY||Difference in proportion|-49.8|||||TWO_SIDED|95.0|-58.0|-41.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-41.6|-58.0|
74023197|NCT03193866|147599167|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-0.1|
74023198|NCT03193866|147599167|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.3|0.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.4|-0.3|
74023199|NCT03193866|147599167|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.2|
74084463|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.84|0.38||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.38|-0.84|
73899635|NCT00329901|147330763|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-7.0|||||TWO_SIDED|95.0|-13.0|-2.0||||||Non-inferiority of anti-PRN antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||-2|-13|
74084464|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.53|0.01||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.01|-1.53|
74084465|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.07|0.47||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.47|-1.07|
74084466|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.65|-0.08||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.08|-1.65|
74084467|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.06|0.55||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.55|-1.06|
74084468|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.72|-0.15||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.15|-1.72|
73847660|NCT01977898|147241002|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||.31
73899636|NCT02296138|147330774|SUPERIORITY|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Ratio of rates vs. Tiotropium 5 μg|0.93||||0.0498|TWO_SIDED|99.0|0.85|1.02|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of moderate to severe COPD exacerbation was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.||1.02|0.85|0.0498
74084469|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.05|0.54||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.54|-1.05|
73847661|NCT01049373|147241004|SUPERIORITY_OR_OTHER|||||||0.0426|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0426
73847662|NCT01049373|147241005|SUPERIORITY_OR_OTHER|||||||0.0757|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0757
73847663|NCT01049373|147241006|SUPERIORITY_OR_OTHER|||||||0.0465|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0465
73847664|NCT01049373|147241007|SUPERIORITY_OR_OTHER|||||||0.04443|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04443
73847665|NCT01365793|147241060|SUPERIORITY|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.34||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests two null hypotheses. The first of these hypotheses - the frequency of GCS score declines to \<14 is equal between the Rapid Rehydration and Slower Rehydration groups - is reported here. The analysis of the second hypothesis is reported below.||||0.34
73960249|NCT02954848|147455865|SUPERIORITY||Median Difference (Final Values)|-0.15||||0.0129|TWO_SIDED|95.0|-0.28|-0.03|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response||-0.0300|-0.2800|0.0129
74023200|NCT03193866|147599167|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.3|
74023201|NCT03193866|147599167|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.1|
74023202|NCT03193866|147599167|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.2|
74023203|NCT03193866|147599167|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.2|-0.1|
74023204|NCT03193866|147599167|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-0.1|
74023205|NCT03193866|147599168|SUPERIORITY||Difference in proportion|4.8|||||TWO_SIDED|95.0|-2.2|11.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||11.9|-2.2|
74023206|NCT03193866|147599168|SUPERIORITY||Difference in proportion|9.0|||||TWO_SIDED|95.0|-2.6|20.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||20.6|-2.6|
74023207|NCT03193866|147599168|SUPERIORITY||Difference in proportion|-0.7|||||TWO_SIDED|95.0|-7.6|6.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.2|-7.6|
74084470|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.8|-0.15||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.15|-1.80|
73847666|NCT01365793|147241060|SUPERIORITY|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.43||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests the two null hypotheses. The second of these hypotheses - the frequency of GCS score declines to \<14 is equal between the 0.45% Saline group and the 0.90% Saline group - is reported here. The analysis of the first hypothesis is reported above.||||0.43
73960250|NCT02954848|147455865|SUPERIORITY||Median Difference (Final Values)|0.17||||0.0765|TWO_SIDED|95.0|-0.01|0.36|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response||0.3600|-0.0100|0.0765
73847667|NCT01469039|147241078|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
73960251|NCT02954848|147455866|SUPERIORITY||Median Difference (Final Values)|6.5||||0.149|TWO_SIDED|95.0|-1.9|15.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings||15.300|-1.900|0.1490
73847668|NCT01469039|147241078|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
73847669|NCT01469039|147241079|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF|||||||<0.001
73847670|NCT01469039|147241079|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF|||||||<0.001
73960252|NCT02954848|147455866|SUPERIORITY||Median Difference (Final Values)|3.6||||0.2146|TWO_SIDED|95.0|-1.4|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings||10.700|-1.400|0.2146
73960253|NCT02954848|147455867|SUPERIORITY|||||||0.0059|||||||Log Rank|||||||0.0059
74023208|NCT03193866|147599168|SUPERIORITY||Difference in proportion|-2.6|||||TWO_SIDED|95.0|-9.4|4.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.1|-9.4|
74023209|NCT03193866|147599168|SUPERIORITY||Difference in proportion|-2.6|||||TWO_SIDED|95.0|-8.6|3.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.4|-8.6|
74084471|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.04|0.61||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.61|-1.04|
73847671|NCT03623698|147241081|OTHER||Median Difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-4.0|-1.5|||Wilcoxon (Mann-Whitney)|||"Statistical analysis was performed using IBM SPSS Statistics software, version 25.~This analysis applies to the category of Total courses of antibiotics."||-1.500|-4.000|<0.001
73847672|NCT03623698|147241081|OTHER|Linear mixed-effects model|Restricted Maximum Likelihood (REML)|-2.88||||0.001|TWO_SIDED|95.0|-4.46|-1.29||95% confidence interval, significance level p-values \<0.05. Random effects pre-defined from theory and published data, and AIC was were used to define the best model. Outcome measures: Courses of antibiotics; Fixed effect: nebulised saline treatment.|Mixed Models Analysis|Random effects: age, gender, mechanical ventilation, tracheostomy, gastrostomy, non-ambulant.||"Statistical analysis was performed using IBM SPSS Statistics software, version 25.~This analysis applies to the category of Total courses of antibiotics."||-1.29|-4.46|0.001
73847673|NCT03623698|147241082|OTHER||Median Difference (Final Values)|-1.0||||0.001|TWO_SIDED|95.0|-1.5|-0.5|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed using IBM SPSS Statistics software, version 25.||-0.50|-1.50|0.001
73960254|NCT02954848|147455868|SUPERIORITY|||||||0.0153|||||||Log Rank|||||||0.0153
73960255|NCT02954848|147455869|SUPERIORITY||Median Difference (Final Values)|-0.18||||0.0757|TWO_SIDED|95.0|-0.43|0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings||0.0200|-0.4300|0.0757
73960256|NCT02954848|147455869|SUPERIORITY||Median Difference (Final Values)|-0.07||||0.3837|TWO_SIDED|95.0|-0.22|0.09|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings||0.0900|-0.2200|0.3837
73960257|NCT02954848|147455870|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6631|TWO_SIDED|95.0|-5.0|3.5|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response||3.500|-5.000|0.6631
73960258|NCT02954848|147455870|SUPERIORITY||Median Difference (Final Values)|3.2||||0.5627|TWO_SIDED|95.0|-7.1|13.9|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response||13.900|-7.100|0.5627
73960259|NCT02954848|147455870|SUPERIORITY||Median Difference (Final Values)|3.7||||0.0042|TWO_SIDED|95.0|0.0|8.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response||8.000|0.000|0.0042
73960260|NCT02954848|147455870|SUPERIORITY||Median Difference (Final Values)|-0.7||||0.6452|TWO_SIDED|95.0|-9.4|6.4|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response||6.400|-9.400|0.6452
73960261|NCT02954848|147455870|SUPERIORITY||Median Difference (Final Values)|7.4||||0.0376|TWO_SIDED|95.0|0.0|17.8|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response||17.800|0.000|0.0376
73960262|NCT02954848|147455870|SUPERIORITY||Median Difference (Final Values)|-13.0||||0.16|TWO_SIDED|95.0|-35.7|3.6|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response||3.600|-35.700|0.1600
73960263|NCT02954848|147455870|SUPERIORITY||Median Difference (Final Values)|3.6||||0.1032|TWO_SIDED|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response||10.700|0.000|0.1032
73960264|NCT02954848|147455870|SUPERIORITY||Median Difference (Final Values)|-3.3||||0.2613|TWO_SIDED|95.0|-14.3|0.2|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved response||0.200|-14.300|0.2613
73960265|NCT02954848|147455871|SUPERIORITY|||||||0.997|||||||Log Rank|||||||0.9970
73960266|NCT02954848|147455872|SUPERIORITY|||||||0.0125|||||||Log Rank|||||||0.0125
73960267|NCT02954848|147455873|SUPERIORITY|||||||0.0004|||||||Log Rank|||||||0.0004
73960268|NCT02954848|147455874|SUPERIORITY|||||||0.7999|||||||Log Rank|||||||0.7999
73960269|NCT02954848|147455875|SUPERIORITY|||||||0.0059|||||||Log Rank|||||||0.0059
73960270|NCT02954848|147455876|SUPERIORITY|||||||0.552|||||||Log Rank|||||||0.5520
73960271|NCT02954848|147455877|SUPERIORITY|||||||0.0175|||||||Log Rank|||||||0.0175
73960272|NCT02954848|147455878|SUPERIORITY|||||||0.7505|||||||Log Rank|||||||0.7505
73960273|NCT02954848|147455879|SUPERIORITY||Median Difference (Final Values)|-0.03||||0.7845|TWO_SIDED|95.0|-0.23|0.16|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response||0.1600|-0.2300|0.7845
73960274|NCT02954848|147455879|SUPERIORITY||Wilcoxon Rank-Sum Test|-0.11||||0.4456|TWO_SIDED|95.0|-0.33|0.17|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response||0.1700|-0.3300|0.4456
74023210|NCT03193866|147599168|SUPERIORITY||Difference in proportion|3.8|||||TWO_SIDED|95.0|-4.7|12.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||12.2|-4.7|
73899637|NCT02296138|147330774|SUPERIORITY||Ratio of rates|0.89||||0.001|TWO_SIDED|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on SPARK/FLAME- Covariates: Smoking status, baseline inhaled corticosteroid, Global Initiative on Chronic Obstructive Lung Disease stage, region, COPD Assessment Test score (replacing baseline symptom score), exacerbations treated with antibiotics/steroids history in previous year (replacing 1-year history of exacerbations)||0.96|0.84|0.0010
73899638|NCT02296138|147330774|SUPERIORITY||Ratio of rates|0.91||||0.008|TWO_SIDED|95.0|0.85|0.98|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on HERMES- Covariates: age, sex, smoking status, baseline Long-acting Beta-agonist/inhaled corticosteroid, region and percent predicted post-bronchodilator Forced Expiratory Volume in One Second||0.98|0.85|0.0080
73899639|NCT02296138|147330774|SUPERIORITY||Ratio of rates|0.89||||0.0011|TWO_SIDED|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on TRINITY/TRILOGY- Covariates: Treatment, region, severity of airflow limitation, and smoking status as effects, and exacerbations treated with antibiotics/steroids in previous year.||0.96|0.84|0.0011
73899640|NCT02296138|147330775|SUPERIORITY|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Hazard Ratio (HR)|0.95||||0.1188|TWO_SIDED|99.0|0.87|1.03|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.03|0.87|0.1188
73899641|NCT02296138|147330776|SUPERIORITY||Ratio of events vs. Tiotropium 5 μg|0.89||||0.1265|TWO_SIDED|95.0|0.76|1.03|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of exacerbations leading to hospitalization was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.||1.03|0.76|0.1265
73960275|NCT02954848|147455879|SUPERIORITY||Median Difference (Final Values)|-0.15||||0.02|TWO_SIDED|95.0|-0.29|-0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response||-0.0200|-0.2900|0.0200
73960276|NCT02954848|147455879|SUPERIORITY||Median Difference (Final Values)|0.06||||0.4673|TWO_SIDED|95.0|-0.1|0.22|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response||0.2200|-0.1000|0.4673
73960277|NCT02954848|147455879|SUPERIORITY||Median Difference (Final Values)|-0.29||||0.0095|TWO_SIDED|95.0|-0.53|-0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response||-0.0700|-0.5300|0.0095
73960278|NCT02954848|147455879|SUPERIORITY||Median Difference (Final Values)|0.31||||0.165|TWO_SIDED|95.0|-0.16|0.71|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response||0.7100|-0.1600|0.1650
73960279|NCT02954848|147455879|SUPERIORITY||Median Difference (Final Values)|-0.08||||0.2475|TWO_SIDED|95.0|-0.24|0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response||0.0700|-0.2400|0.2475
73960280|NCT02954848|147455879|SUPERIORITY||Median Difference (Final Values)|0.13||||0.2367|TWO_SIDED|95.0|-0.09|0.32|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved||0.3200|-0.0900|0.2367
73960281|NCT02954848|147455880|SUPERIORITY||Median Difference (Final Values)|5.5||||0.1885|TWO_SIDED|95.0|-2.7|14.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response||14.300|-2.700|0.1885
73960282|NCT02954848|147455880|SUPERIORITY||Wilcoxon Rank-Sum Test|25.6||||0.2337|TWO_SIDED|95.0|-19.2|75.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response||75.000|-19.200|0.2337
73960283|NCT02954848|147455881|SUPERIORITY|||||||0.0811|||||||Log Rank|||||||0.0811
73960284|NCT02954848|147455882|SUPERIORITY|||||||0.0288|||||||Log Rank|||||||0.0288
73960285|NCT02954848|147455883|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.1488|TWO_SIDED|95.0|-0.42|0.04|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response||0.0400|-0.4200|0.1488
73960286|NCT02954848|147455883|SUPERIORITY||Wilcoxon Rank-Sum Test|-0.44||||0.3778|TWO_SIDED|95.0|-1.57|0.69|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response||0.6900|-1.5700|0.3778
73960287|NCT01184508|147455885|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference (Net)|-1.03||||0.085|TWO_SIDED|90.0|-2.02|-0.05||The comparison between LY2300559 and placebo for the LS mean change from baseline to Month 3 in the number of migraine attacks was conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||-0.05|-2.02|0.085
73960288|NCT01184508|147455887|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|1.75||||0.77|TWO_SIDED|90.0|-8.27|11.76||The p-value is for the change from baseline to Month 3 in average duration of photophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||11.76|-8.27|0.770
73960289|NCT01184508|147455887|SUPERIORITY_OR_OTHER||LS mean difference|7.3||||0.276|TWO_SIDED|90.0|-3.91|18.52||The p-value is for the change from baseline to Month 3 in average duration of phonophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||18.52|-3.91|0.276
73960290|NCT01184508|147455887|SUPERIORITY_OR_OTHER||LS mean difference|-2.7||||0.606|TWO_SIDED|90.0|-11.51|6.1||The p-value is for the change from baseline to Month 3 in average duration of nausea.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||6.10|-11.51|0.606
73960291|NCT01184508|147455888|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-1.57||||0.174|TWO_SIDED|90.0|-3.48|0.34||The p-value is for the mean change from baseline to Month 3 in the number of migraine days.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||0.34|-3.48|0.174
73960292|NCT01184508|147455891|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.27||||0.963|TWO_SIDED|90.0|-9.76|9.23||The p-value is for the change from baseline to Week 12 in MSQ restrictive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||9.23|-9.76|0.963
74023211|NCT03193866|147599168|SUPERIORITY||Difference in proportion|0.6|||||TWO_SIDED|95.0|-6.9|8.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.1|-6.9|
73899642|NCT02296138|147330777|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.2773|TWO_SIDED|95.0|0.82|1.06|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.06|0.82|0.2773
73899643|NCT02296138|147330778|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7357|TWO_SIDED|95.0|0.67|1.75|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.75|0.67|0.7357
73899644|NCT02692651|147330796|SUPERIORITY|||||||0.195|||||||Chi-squared, Corrected|||||||0.195
73899645|NCT02692651|147330797|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||||||.99
73899646|NCT02692651|147330798|SUPERIORITY|||||||0.999|||||||Chi-squared, Corrected|||||||.999
73899647|NCT01860846|147330825|SUPERIORITY_OR_OTHER||||||=|0.004||||||Baseline vs. 12 months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||=0.004
73899648|NCT01860846|147330826|SUPERIORITY_OR_OTHER||||||=|0.022||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||= 0.022
73899649|NCT01860846|147330827|SUPERIORITY_OR_OTHER||||||=|0.006||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||= 0.006
74023212|NCT03193866|147599168|SUPERIORITY||Difference in proportion|3.9|||||TWO_SIDED|95.0|-6.3|14.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||14.1|-6.3|
74023213|NCT03193866|147599169|SUPERIORITY||Difference in proportion|-34.1|||||TWO_SIDED|95.0|-40.3|-27.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-27.9|-40.3|
73899650|NCT01860846|147330828|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||< 0.001
73899651|NCT01860846|147330829|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Physical Functioning Scores: the null hypothesis was set as no difference.||||< 0.001
73899652|NCT01860846|147330829|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Physical Scores: the null hypothesis was set as no difference.||||< 0.001
73899653|NCT01860846|147330829|SUPERIORITY_OR_OTHER||||||=|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Emotional Scores: the null hypothesis was set as no difference.||||= 0.001
73899654|NCT01860846|147330829|SUPERIORITY_OR_OTHER||||||=|0.019||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Vitality Scores: the null hypothesis was set as no difference.||||= 0.019
74084472|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.65|-0.05||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.05|-1.65|
73899655|NCT01860846|147330829|SUPERIORITY_OR_OTHER||||||=|0.017||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Mental Health Scores: the null hypothesis was set as no difference.||||= 0.017
73899656|NCT01860846|147330829|SUPERIORITY_OR_OTHER||||||=|0.007||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Functioning Scores: the null hypothesis was set as no difference.||||= 0.007
73899657|NCT01860846|147330829|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bodily Pain Scores: the null hypothesis was set as no difference.||||< 0.001
73899658|NCT01860846|147330829|SUPERIORITY_OR_OTHER||||||=|0.005||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||General Health Scores: the null hypothesis was set as no difference.||||= 0.005
73899659|NCT01860846|147330830|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bowel-related Symptoms Scores: The null hypothesis was set as no difference.||||< 0.001
73899660|NCT01860846|147330830|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Systemic Symptoms Scores:The null hypothesis was set as no difference.||||< 0.001
73899661|NCT01860846|147330830|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Emotional Function Scores: the null hypothesis was set as no difference.||||< 0.001
73899662|NCT01860846|147330830|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Function Scores: The null hypothesis was set as no difference.||||< 0.001
73899663|NCT01856764|147330834|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.496||0.276|TWO_SIDED|95.0|-1.5542|0.4574||Mixed Model Repeated Measures (MMRM) Model: SCORAD change from baseline = treatment + visit + treatment by visit interaction + baseline SCORAD score|Mixed Models Analysis|||||0.4574|-1.5542|0.276
73899664|NCT01856764|147330835|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.91|STANDARD_ERROR_OF_MEAN|3.454||0.095|TWO_SIDED|95.0|-12.9134|1.0835||MMRM model: TEWL change from baseline = treatment + visit + treatment by visit interaction + baseline TEWL score|Mixed Models Analysis|||||1.0835|-12.9134|0.095
74023214|NCT03193866|147599169|SUPERIORITY||Difference in proportion|-32.2|||||TWO_SIDED|95.0|-43.0|-21.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-21.5|-43.0|
74023215|NCT03193866|147599169|SUPERIORITY||Difference in proportion|-21.8|||||TWO_SIDED|95.0|-27.9|-15.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-15.7|-27.9|
74084473|NCT02725411|147722163|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.88|0.71||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.71|-0.88|
74084474|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.77|0.04||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.04|-1.77|
74084475|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.96|-0.14||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||-0.14|-1.96|
74084476|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.48|0.43||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.43|-1.48|
74084477|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.43|0.51||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.51|-1.43|
74084478|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.04|0.91||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.91|-1.04|
74084479|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.53|0.44||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.44|-1.53|
74084480|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.06|1.05||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.05|-1.06|
74084481|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.6|0.53||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.53|-1.60|
74084482|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.71|0.88||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.88|-1.71|
74084483|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.47|1.14||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.14|-1.47|
73847674|NCT03623698|147241082|OTHER||Restricted Maximum Likelihood (REML)|-1.02|||<|0.001|TWO_SIDED|95.0|-1.53|-0.52||95% confidence interval, significance level p-values \<0.05. Random effects pre-defined from theory and published data, and AIC was were used to define the best model. Outcome measures: Courses of antibiotics; Fixed effect: nebulised saline treatment.|Mixed Models Analysis|Random effects: age, gender, prolonged mechanical ventilation (nasal or tracheostomy), and antibiotic prophylaxis||Statistical analysis was performed using IBM SPSS Statistics software, version 25.||-0.52|-1.53|<0.001
73847675|NCT03623698|147241085|OTHER||Median Difference (Final Values)|-4.5||||0.003|TWO_SIDED|95.0|-5.5|-3.0|||Wilcoxon (Mann-Whitney)|||||-3.00|-5.50|0.003
73847676|NCT03623698|147241086|OTHER||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-2.0|||Wilcoxon (Mann-Whitney)|||||-2.0|-2.5|<0.001
74084484|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-1.9|0.71||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.71|-1.90|
74023216|NCT03193866|147599169|SUPERIORITY||Difference in proportion|-7.8|||||TWO_SIDED|95.0|-14.5|-1.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-1.2|-14.5|
74023217|NCT03193866|147599169|SUPERIORITY||Difference in proportion|-23.6|||||TWO_SIDED|95.0|-28.9|-18.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-18.3|-28.9|
73847677|NCT03623698|147241089|OTHER||Mean Difference (Final Values)|0.17||||0.97|TWO_SIDED|95.0|-0.69|0.76|||Wilcoxon (Mann-Whitney)|||||0.76|-0.69|0.97
73847678|NCT03623698|147241090|OTHER||Mean Difference (Final Values)|-1.47||||0.09|TWO_SIDED|95.0|-3.26|0.34|||Wilcoxon (Mann-Whitney)|||||0.34|-3.26|0.09
73847679|NCT03623698|147241091|OTHER||Mean Difference (Final Values)|-0.08||||0.65|TWO_SIDED|95.0|-0.38|0.38|||Wilcoxon (Mann-Whitney)|||||0.38|-0.38|0.65
73899665|NCT01856764|147330836|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.596||0.013|TWO_SIDED|95.0|-2.7656|-0.3492||MMRM model: Assessment of Pruritus change from baseline = treatment + visit + treatment by visit interaction + baseline Assessment of Pruritus score|Mixed Models Analysis|||||-0.3492|-2.7656|0.013
73899666|NCT02239120|147330837|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1028|TWO_SIDED|95.0|0.69|1.03|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.03|0.69|0.1028
73899667|NCT02239120|147330838|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.1076|TWO_SIDED|95.0|0.94|1.97|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.97|0.94|0.1076
73899668|NCT02239120|147330839|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0892|TWO_SIDED|95.0|0.68|1.03|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.03|0.68|0.0892
73899669|NCT02239120|147330840|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1911|TWO_SIDED|95.0|0.73|1.06|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.06|0.73|0.1911
73960293|NCT01184508|147455891|SUPERIORITY_OR_OTHER||LS mean difference|-2.17||||0.591|TWO_SIDED|90.0|-8.85|4.5||The p-value is for the change from baseline to Week 12 in MSQ preventive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||4.50|-8.85|0.591
73847680|NCT00811954|147241096|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|3.4|||||TWO_SIDED|97.5|-0.7|7.4||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||7.4|-0.7|
73847681|NCT00811954|147241096|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|5.6|||||TWO_SIDED|97.5|1.3|9.9||||||Treatment comparison was made using the difference (arm C - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||9.9|1.3|
73847682|NCT00811954|147241096|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|-2.2|||||TWO_SIDED|97.5|-6.7|2.3||||||Treatment comparison was made using the difference (arm A - arm C) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||2.3|-6.7|
73899670|NCT02239120|147330841|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0354|TWO_SIDED|95.0|0.36|0.96|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||0.96|0.36|0.0354
73899671|NCT02239120|147330842|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.8074|TWO_SIDED|95.0|0.66|1.38|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.38|0.66|0.8074
73899672|NCT02239120|147330843|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9064|TWO_SIDED|95.0|0.58|1.83|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.83|0.58|0.9064
73899673|NCT02239120|147330845|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.4352|TWO_SIDED|95.0|0.49|1.36|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.36|0.49|0.4352
73899674|NCT02239120|147330846|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.0003|TWO_SIDED|95.0|1.12|1.47|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.47|1.12|0.0003
73899675|NCT05072470|147330866|SUPERIORITY|When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|||||<|0.01|||||||t-test, 2 sided|||Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at 0 dB SNR||||<0.01
74023218|NCT03193866|147599169|SUPERIORITY||Difference in proportion|-12.7|||||TWO_SIDED|95.0|-18.9|-6.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-6.5|-18.9|
74023219|NCT03193866|147599169|SUPERIORITY||Difference in proportion|-26.5|||||TWO_SIDED|95.0|-32.8|-20.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-20.2|-32.8|
74023220|NCT03193866|147599169|SUPERIORITY||Difference in proportion|-31.7|||||TWO_SIDED|95.0|-40.1|-23.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-23.2|-40.1|
73847683|NCT00811954|147241097|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|12.8|||||TWO_SIDED|97.5|9.4|16.1||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.||16.1|9.4|
73899676|NCT05072470|147330866|SUPERIORITY|||||||0.031||||||When p value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at -5 dB SNR||||.031
73899677|NCT05072470|147330866|SUPERIORITY|||||||0.046||||||When p-values are adjusted for multiple comparisons, the level of statistical significance must be \</= .01666667 (.05/3)|t-test, 2 sided|||Speech intelligibility will be equal or better with hearing aids plus Roger device than with hearing aids alone when tested using standardized speech test at +5 dB SNR.||||.046
73899678|NCT00420641|147330867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.485|TWO_SIDED|90.0|-2.6|1.05|||Mixed Model Repeated Measures (MMRM)||The point estimate was calculated as least square (LS) mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS total score at Week 10.||1.05|-2.60|0.485
73899679|NCT00420641|147330867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.99||||0|TWO_SIDED|90.0|-5.75|-2.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.||-2.22|-5.75|0.000
74084485|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.44|1.25||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.25|-1.44|
74023221|NCT03193866|147599170|SUPERIORITY||Difference in proportion|-33.2|||||TWO_SIDED|95.0|-39.4|-27.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-27.0|-39.4|
74084486|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.43|0.28||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.28|-2.43|
74084487|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.41|1.32||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.32|-1.41|
74084488|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.17|0.57||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.57|-2.17|
73899680|NCT00420641|147330868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.252|TWO_SIDED|90.0|-1.28|0.23|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in Bech score at Week 10.||0.23|-1.28|0.252
73899681|NCT00420641|147330868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0|TWO_SIDED|90.0|-2.49|-1.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.||-1.05|-2.49|0.000
73899682|NCT00420641|147330869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.66||||0.279|TWO_SIDED|90.0|-4.19|0.87|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR total score at Week 10.||0.87|-4.19|0.279
73899683|NCT00420641|147330869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.12||||0.001|TWO_SIDED|90.0|-7.55|-2.68|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR total score at Week 10.||-2.68|-7.55|0.001
73960294|NCT01184508|147455891|SUPERIORITY_OR_OTHER||LS mean difference|1.89||||0.72|TWO_SIDED|90.0|-6.81|10.58||The p-value is for the change from baseline to Week 12 in MSQ emotional function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||10.58|-6.81|0.720
73899684|NCT00420641|147330870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.287|TWO_SIDED|90.0|-5.23|1.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR total score at Week 10.||1.12|-5.23|0.287
73960295|NCT01184508|147455892|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.25||||0.688|TWO_SIDED|90.0|-1.3|0.8||The p-value is for the change from baseline to Week 12 in MIBS-4 overall weighted score.|ANCOVA|Fixed effects: pooled investigator, treatment group, and baseline.||||0.80|-1.30|0.688
73960296|NCT01184508|147455894|SUPERIORITY_OR_OTHER|||||||0.607||95.0||||The p-value is for the percentage of participants using breakthrough medication at Month 3.|Fisher Exact|||||||0.607
73960297|NCT03684265|147455904|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|92.74|STANDARD_ERROR_OF_MEAN|8.66|||TWO_SIDED|95.0|89.02|96.62|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-t. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||96.62|89.02|
73960298|NCT03684265|147455905|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|78.94|STANDARD_ERROR_OF_MEAN|14.57|||TWO_SIDED|90.0|73.7|84.56|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for Cmax. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||84.56|73.70|
73960299|NCT03684265|147455906|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|97.04|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|90.0|92.57|101.72|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-∞. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||101.72|92.57|
73960300|NCT04707313|147455934|SUPERIORITY||Difference to placebo|-5.6|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-7.41|-3.74|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-3.74|-7.41|<.0001
73960301|NCT04707313|147455934|SUPERIORITY||Difference to placebo|-5.0|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-6.8|-3.16|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-3.16|-6.80|<.0001
73960302|NCT04707313|147455934|SUPERIORITY||Difference to Placebo|-9.1|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-10.89|-7.28|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.28|-10.89|<.0001
73960303|NCT04707313|147455934|SUPERIORITY||Difference to Placebo|-6.6|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|90.0|-8.75|-4.39|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.39|-8.75|<.0001
73960304|NCT04707313|147455934|SUPERIORITY||Difference to Placebo|-9.52|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|90.0|-11.43|-7.56|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.56|-11.43|<.0001
73960305|NCT04707313|147455934|SUPERIORITY||Difference to Placebo|-7.12|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|90.0|-9.41|-4.78|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.78|-9.41|<.0001
73899685|NCT00420641|147330870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23||||0.001|TWO_SIDED|90.0|-9.21|-3.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR total score at Week 10.||-3.25|-9.21|0.001
73899686|NCT00420641|147330871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.352|TWO_SIDED|90.0|-1.47|0.41|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-CR16 total score at Week 10.||0.41|-1.47|0.352
73899687|NCT00420641|147330871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.002|TWO_SIDED|90.0|-2.62|-0.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-CR16 total score at Week 10.||-0.81|-2.62|0.002
73899688|NCT00420641|147330872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.168|TWO_SIDED|90.0|-2.27|0.2|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-SR16 total score at Week 10.||0.20|-2.27|0.168
73899689|NCT00420641|147330872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.002|TWO_SIDED|90.0|-3.27|-0.97|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-SR16 total score at Week 10.||-0.97|-3.27|0.002
73899690|NCT00420641|147330873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.257|TWO_SIDED|90.0|-0.46|0.09|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS Item 2 score at Week 10.||0.09|-0.46|0.257
73960306|NCT04707313|147455934|SUPERIORITY||Difference to Placebo|-9.12|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|90.0|-11.11|-7.08|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.08|-11.11|<.0001
74023222|NCT03193866|147599170|SUPERIORITY||Difference in proportion|-30.6|||||TWO_SIDED|95.0|-41.4|-19.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-19.8|-41.4|
73899691|NCT00420641|147330873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.001|TWO_SIDED|90.0|-0.77|-0.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS Item 2 score at Week 10.||-0.25|-0.77|0.001
73899692|NCT00420641|147330874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.096|TWO_SIDED|90.0|-0.33|0.0|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR Item 5 score at Week 10.||-0.00|-0.33|0.096
73899693|NCT00420641|147330874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0|TWO_SIDED|90.0|-0.53|-0.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR Item 5 at Week 10.||-0.22|-0.53|0.000
73899694|NCT00420641|147330875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.576|TWO_SIDED|90.0|-1.84|0.91|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 total score at Week 10.||0.91|-1.84|0.576
73899695|NCT00420641|147330875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||0|TWO_SIDED|90.0|-4.28|-1.64|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 total score at Week 10.||-1.64|-4.28|0.000
73899696|NCT00420641|147330876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.209|TWO_SIDED|90.0|-0.38|0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 Item 1 score at Week 10.||0.05|-0.38|0.209
73899697|NCT00420641|147330876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.002|TWO_SIDED|90.0|-0.6|-0.19|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 Item 1 score at Week 10.||-0.19|-0.60|0.002
73899698|NCT00420641|147330877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.175|TWO_SIDED|90.0|-1.23|0.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR 5 Item subscale total score at Week 10.||0.12|-1.23|0.175
73899699|NCT00420641|147330877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.003|TWO_SIDED|90.0|-1.79|-0.5|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR 5 Item subscale total score at Week 10.||-0.50|-1.79|0.003
73899700|NCT00420641|147330877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.082|TWO_SIDED|90.0|-1.92|-0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR 5 Item subscale total score at Week 10.||-0.05|-1.92|0.082
73899701|NCT00420641|147330877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0.001|TWO_SIDED|90.0|-2.64|-0.9|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR 5 Item subscale total score at Week 10.||-0.90|-2.64|0.001
73899702|NCT00420641|147330878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.208|TWO_SIDED|90.0|-0.45|0.06|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CGI-S score at Week 10.||0.06|-0.45|0.208
73899703|NCT00420641|147330878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0|TWO_SIDED|90.0|-0.76|-0.28|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CGI-S score at Week 10.||-0.28|-0.76|0.000
73899704|NCT00420641|147330879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.76||||0.516|TWO_SIDED|90.0|-2.71|6.24|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MEI total score at Week 10.||6.24|-2.71|0.516
73899705|NCT00420641|147330879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22||||0.016|TWO_SIDED|90.0|1.97|10.48|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MEI total score at Week 10.||10.48|1.97|0.016
73899706|NCT00420641|147330880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.126|TWO_SIDED|90.0|-0.13|3.57|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CSFQ-14SF total score at Week 10.||3.57|-0.13|0.126
73899707|NCT00420641|147330880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.957|TWO_SIDED|90.0|-1.69|1.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CSFQ-14SF total score at Week 10.||1.81|-1.69|0.957
73899708|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.5061|TWO_SIDED|90.0|0.21|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 1.||1.93|0.21|0.5061
73899709|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.7398|TWO_SIDED|90.0|0.46|3.25|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 1.||3.25|0.46|0.7398
73899710|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.9209|TWO_SIDED|90.0|0.52|2.08|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 2.||2.08|0.52|0.9209
73899711|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.2908|TWO_SIDED|90.0|0.78|3.13|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 2.||3.13|0.78|0.2908
74023223|NCT03193866|147599170|SUPERIORITY||Difference in proportion|-20.8|||||TWO_SIDED|95.0|-27.0|-14.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-14.7|-27.0|
73899712|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.0086|TWO_SIDED|90.0|0.23|0.72|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 3.||0.72|0.23|0.0086
74023224|NCT03193866|147599170|SUPERIORITY||Difference in proportion|-7.0|||||TWO_SIDED|95.0|-13.6|-0.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.3|-13.6|
73899713|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.8087|TWO_SIDED|90.0|0.64|1.83|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 3.||1.83|0.64|0.8087
73899714|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31||||0.0002|TWO_SIDED|90.0|0.18|0.52|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 4.||0.52|0.18|0.0002
73899715|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.4606|TWO_SIDED|90.0|0.78|1.94|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 4.||1.94|0.78|0.4606
73899716|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.1399|TWO_SIDED|90.0|0.4|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 5.||1.05|0.40|0.1399
73960307|NCT04707313|147455934|SUPERIORITY||Difference to Placebo|-7.18|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|90.0|-9.32|-4.99|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.99|-9.32|<.0001
73960308|NCT04707313|147455935|SUPERIORITY||Difference to Placebo|-8.21|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-11.66|-4.63|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.63|-11.66|<.0001
73960309|NCT04707313|147455935|SUPERIORITY||Difference to placebo|-8.44|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-11.83|-4.92|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.92|-11.83|<.0001
73899717|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0461|TWO_SIDED|90.0|1.1|2.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 5.||2.73|1.10|0.0461
73899718|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.14|TWO_SIDED|90.0|0.41|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 6.||1.05|0.41|0.1400
73899719|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.71||||0.0002|TWO_SIDED|90.0|1.74|4.21|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 6.||4.21|1.74|0.0002
73899720|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9596|TWO_SIDED|90.0|0.59|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 8.||1.64|0.59|0.9596
73899721|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24||||0|TWO_SIDED|90.0|2.01|5.23|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 8.||5.23|2.01|0.0000
73899722|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.653|TWO_SIDED|90.0|0.69|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 10.||1.93|0.69|0.6530
73899723|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.48||||0|TWO_SIDED|90.0|2.11|5.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 10.||5.73|2.11|0.0000
73899724|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.8844|TWO_SIDED|90.0|0.23|3.48|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 1.||3.48|0.23|0.8844
73899725|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.7425|TWO_SIDED|90.0|0.36|4.68|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 1.||4.68|0.36|0.7425
73899726|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8355|TWO_SIDED|90.0|0.39|2.07|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 2.||2.07|0.39|0.8355
73899727|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.1786|TWO_SIDED|90.0|0.86|4.32|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 2.||4.32|0.86|0.1786
73899728|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.0835|TWO_SIDED|90.0|0.26|0.97|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 3.||0.97|0.26|0.0835
73899729|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8558|TWO_SIDED|90.0|0.58|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 3.||1.98|0.58|0.8558
73899730|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.0067|TWO_SIDED|90.0|0.2|0.67|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 4.||0.67|0.20|0.0067
73899731|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6647|TWO_SIDED|90.0|0.67|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 4.||1.98|0.67|0.6647
73899732|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9553|TWO_SIDED|90.0|0.55|1.74|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 5.||1.74|0.55|0.9553
73899733|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58||||0.004||90.0|1.5|4.42|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 5.||4.42|1.50|0.0040
73899734|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6327|TWO_SIDED|90.0|0.52|1.43|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 6.||1.43|0.52|0.6327
73899735|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0027|TWO_SIDED|90.0|1.47|3.79|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 6.||3.79|1.47|0.0027
73899736|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3961|TWO_SIDED|90.0|0.45|1.29|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 8.||1.29|0.45|0.3961
73899737|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0298|TWO_SIDED|90.0|1.17|3.06|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 8.||3.06|1.17|0.0298
73899738|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.8826|TWO_SIDED|90.0|0.56|1.61|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 10.||1.61|0.56|0.8826
73899739|NCT00420641|147330884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.0022|TWO_SIDED|90.0|1.52|4.05|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 10.||4.05|1.52|0.0022
73899740|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.5072|TWO_SIDED|90.0|0.22|1.89|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 1.||1.89|0.22|0.5072
73899741|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6886|TWO_SIDED|90.0|0.52|2.93|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 1.||2.93|0.52|0.6886
73899742|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8664|TWO_SIDED|90.0|0.56|2.04|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 2.||2.04|0.56|0.8664
73899743|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.2897|TWO_SIDED|90.0|0.8|2.79|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 2.||2.79|0.80|0.2897
73960310|NCT04707313|147455935|SUPERIORITY||Difference to Placebo|-12.87|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-16.15|-9.47|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-9.47|-16.15|<.0001
73960311|NCT04707313|147455948|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|7.37|||||TWO_SIDED|90.0|2.81|19.3||||||||19.30|2.81|
73960312|NCT04707313|147455948|SUPERIORITY||Odds Ratio (OR)|6.58|||||TWO_SIDED|90.0|2.62|16.53||||||Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.||16.53|2.62|
73960313|NCT04707313|147455948|SUPERIORITY||Odds Ratio (OR)|16.33|||||TWO_SIDED|90.0|6.47|41.24||||||Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.||41.24|6.47|
73960314|NCT04707313|147455948|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|14.24|||||TWO_SIDED|90.0|5.39|37.66||||||||37.66|5.39|
73960315|NCT04707313|147455948|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|30.17|||||TWO_SIDED|90.0|11.35|80.2||||||||80.20|11.35|
73960316|NCT04707313|147455948|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|9.88|||||TWO_SIDED|90.0|2.91|33.53||||||||33.53|2.91|
73899744|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.2474|TWO_SIDED|90.0|0.39|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 3.||1.18|0.39|0.2474
73899745|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.2007|TWO_SIDED|90.0|0.89|2.47|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 3.||2.47|0.89|0.2007
73899746|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.0214|TWO_SIDED|90.0|0.29|0.82|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 4.||0.82|0.29|0.0214
73899747|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.2368|TWO_SIDED|90.0|0.88|2.23|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 4.||2.23|0.88|0.2368
73899748|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.987|TWO_SIDED|90.0|0.63|1.59|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 5.||1.59|0.63|0.9870
73899749|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.0193|TWO_SIDED|90.0|1.21|3.0|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 5.||3.00|1.21|0.0193
73899750|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8351|TWO_SIDED|90.0|0.59|1.5|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 6.||1.50|0.59|0.8351
73847684|NCT00811954|147241097|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|3.6|||||TWO_SIDED|97.5|1.4|5.8||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm C and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm C - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.||5.8|1.4|
73899751|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.0001|TWO_SIDED|90.0|1.9|4.77|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 6.||4.77|1.90|0.0001
73899752|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.751|TWO_SIDED|90.0|0.67|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 8.||1.80|0.67|0.7510
73899753|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.0029|TWO_SIDED|90.0|1.47|3.8|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 8.||3.80|1.47|0.0029
73899754|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.1707|TWO_SIDED|90.0|0.92|2.55|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 10.||2.55|0.92|0.1707
73899755|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27||||0.0001|TWO_SIDED|90.0|1.99|5.36|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 10.||5.36|1.99|0.0001
73899756|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.205|TWO_SIDED|90.0|0.05|1.48|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 1.||1.48|0.05|0.2050
73899757|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.1735|TWO_SIDED|90.0|0.11|1.24|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 1.||1.24|0.11|0.1735
73899758|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.2305|TWO_SIDED|90.0|0.78|4.75|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 2.||4.75|0.78|0.2305
73899759|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.2507|TWO_SIDED|90.0|0.77|4.5|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 2.||4.50|0.77|0.2507
73899760|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.5608|TWO_SIDED|90.0|0.35|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 3.||1.64|0.35|0.5608
73899761|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.6526|TWO_SIDED|90.0|0.6|2.42|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 3.||2.42|0.60|0.6526
73899762|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.0208|TWO_SIDED|90.0|0.21|0.77|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 4.||0.77|0.21|0.0208
73899763|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2859|TWO_SIDED|90.0|0.39|1.22|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 4.||1.22|0.39|0.2859
73899764|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.7921|TWO_SIDED|90.0|0.49|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 5.||1.66|0.49|0.7921
73899765|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.362|TWO_SIDED|90.0|0.79|2.31|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 5.||2.31|0.79|0.3620
73899766|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.4331|TWO_SIDED|90.0|0.44|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 6.||1.34|0.44|0.4331
73899767|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.0047|TWO_SIDED|90.0|1.42|3.75|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 6.||3.75|1.42|0.0047
73899768|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4431|TWO_SIDED|90.0|0.46|1.32|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 8.||1.32|0.46|0.4431
73899769|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1901|TWO_SIDED|90.0|0.9|2.44|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 8.||2.44|0.90|0.1901
73899770|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9222|TWO_SIDED|90.0|0.56|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 10.||1.66|0.56|0.9222
73899771|NCT00420641|147330885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.1665|TWO_SIDED|90.0|0.93|2.43|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 10.||2.43|0.93|0.1665
73899772|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.5057|TWO_SIDED|90.0|0.2|1.98|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 1.||1.98|0.20|0.5057
73899773|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.8633|TWO_SIDED|90.0|0.38|3.3|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 1.||3.30|0.38|0.8633
73899774|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.8428|TWO_SIDED|90.0|0.55|2.16|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 2.||2.16|0.55|0.8428
73899775|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.3416|TWO_SIDED|90.0|0.76|2.84|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 2.||2.84|0.76|0.3416
73899776|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.3287|TWO_SIDED|90.0|0.4|1.26|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 3.||1.26|0.40|0.3287
73899777|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.2112|TWO_SIDED|90.0|0.88|2.57|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 3.||2.57|0.88|0.2112
73899778|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44||||0.0134|TWO_SIDED|90.0|0.26|0.76|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 4.||0.76|0.26|0.0134
74023225|NCT03193866|147599170|SUPERIORITY||Difference in proportion|-23.7|||||TWO_SIDED|95.0|-29.2|-18.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-18.3|-29.2|
74023226|NCT03193866|147599170|SUPERIORITY||Difference in proportion|-12.3|||||TWO_SIDED|95.0|-18.6|-6.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-6.1|-18.6|
74023227|NCT03193866|147599170|SUPERIORITY||Difference in proportion|-25.3|||||TWO_SIDED|95.0|-31.7|-19.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-19.0|-31.7|
74023228|NCT03193866|147599170|SUPERIORITY||Difference in proportion|-29.5|||||TWO_SIDED|95.0|-38.2|-20.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-20.8|-38.2|
74023229|NCT03193866|147599171|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.07|0.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.00|-0.07|
74023230|NCT03193866|147599171|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.09|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|-0.09|
74023231|NCT03193866|147599171|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.03|0.03||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.03|-0.03|
74023232|NCT03193866|147599171|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.03|0.05||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.05|-0.03|
74023233|NCT03193866|147599171|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.04|-0.02|
73847685|NCT00811954|147241097|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|9.2|||||TWO_SIDED|97.5|5.5|12.9||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm C) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm C) in 96 week probability of tolerability failure with 97.5% confidence interval.||12.9|5.5|
74084489|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-1.16|1.64||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.64|-1.16|
73847686|NCT01247064|147241115|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
74084490|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.37|0.35||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.35|-2.37|
73847687|NCT01247064|147241116|SUPERIORITY_OR_OTHER|||||||0.86|||||||Chi-squared|||||||0.86
73847688|NCT01247064|147241117|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
74023234|NCT03193866|147599171|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.01|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|-0.01|
74023235|NCT03193866|147599171|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|0.0|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|0.00|
74023236|NCT03193866|147599171|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.03||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.03|-0.06|
74023237|NCT03193866|147599172|SUPERIORITY||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-3.3|5.2||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.2|-3.3|
74023238|NCT03193866|147599172|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-9.4|6.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.4|-9.4|
73960317|NCT04707313|147455948|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|24.41|||||TWO_SIDED|90.0|8.28|71.95||||||||71.95|8.28|
73960318|NCT04707313|147455948|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|12.65|||||TWO_SIDED|90.0|4.56|35.08||||||||35.08|4.56|
73960319|NCT04707313|147455949|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|33.43|||||TWO_SIDED|90.0|3.05|366.64||||||||366.64|3.05|
73960320|NCT04707313|147455949|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|34.04|||||TWO_SIDED|90.0|3.1|373.85||||||||373.85|3.10|
73960321|NCT04707313|147455949|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|127.21|||||TWO_SIDED|90.0|10.55|1533.46||||||||1533.46|10.55|
73960322|NCT03165175|147455960|SUPERIORITY|||||||0.72||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.72
73960323|NCT03165175|147455961|SUPERIORITY|||||||0.598||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.598
74023239|NCT03193866|147599172|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-4.2|1.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.4|-4.2|
74084491|NCT02725411|147722165|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-1.35|1.42||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.42|-1.35|
73847689|NCT01247064|147241118|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.36
73960324|NCT03165175|147455962|SUPERIORITY|||||||0.954||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.954
73960325|NCT03165175|147455963|SUPERIORITY|||||||0.167||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.167
73960326|NCT03165175|147455964|SUPERIORITY|||||||0.022||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.022
73960327|NCT01378065|147456055|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
73960328|NCT01378065|147456056|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
73960329|NCT01378065|147456057|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
74023240|NCT03193866|147599172|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-5.9|0.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.8|-5.9|
74023241|NCT03193866|147599172|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.9|2.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.5|-2.9|
74023242|NCT03193866|147599172|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-4.0|1.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.8|-4.0|
74023243|NCT03193866|147599172|SUPERIORITY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-7.0|0.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.9|-7.0|
74023244|NCT03193866|147599172|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.9|5.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.4|-2.9|
74023245|NCT03193866|147599173|SUPERIORITY||Mean Difference (Final Values)|-5.5|||||TWO_SIDED|95.0|-8.1|-2.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-2.9|-8.1|
74023246|NCT03193866|147599173|SUPERIORITY||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-10.9|-1.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-1.0|-10.9|
74023247|NCT03193866|147599173|SUPERIORITY||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-4.0|-0.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.8|-4.0|
74023248|NCT03193866|147599173|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-2.1|1.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.5|-2.1|
74023249|NCT03193866|147599173|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.2|0.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.6|-2.2|
74023250|NCT03193866|147599173|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-0.3|2.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.8|-0.3|
74084492|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|13.0|||||TWO_SIDED|95.0|-0.8|26.3||||||Week 16: \>=30%||26.3|-0.8|
74084493|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-1.7|||||TWO_SIDED|95.0|-15.8|12.4||||||Week 16: \>=30%||12.4|-15.8|
74084494|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|18.5|||||TWO_SIDED|95.0|4.2|32.0||||||Week 16: \>=50%||32.0|4.2|
74084495|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|2.9|||||TWO_SIDED|95.0|-10.7|16.3||||||Week 16: \>=50%||16.3|-10.7|
74084496|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|10.9|||||TWO_SIDED|95.0|0.6|20.7||||||Week 16: \>=70%||20.7|0.6|
73960330|NCT01378065|147456058|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
73960331|NCT01378065|147456059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||t-test, 2 sided|||||||0.202
74084497|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.5|||||TWO_SIDED|95.0|-1.4|18.1||||||Week 16: \>=70%||18.1|-1.4|
74084498|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|1.1|||||TWO_SIDED|95.0|-4.3|6.5||||||Week 16: \>=90%||6.5|-4.3|
74084499|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|2.1|||||TWO_SIDED|95.0|-3.7|7.8||||||Week 16: \>=90%||7.8|-3.7|
74084500|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.3|25.7||||||Week 24: \>=30%||25.7|-2.3|
74084501|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-1.6|||||TWO_SIDED|95.0|-15.9|12.6||||||Week 24: \>=30%||12.6|-15.9|
74084502|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.4|25.8||||||Week 24: \>=50%||25.8|-2.4|
74084503|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.0|||||TWO_SIDED|95.0|-9.1|18.9||||||Week 24: \>=50%||18.9|-9.1|
74084504|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|14.1|||||TWO_SIDED|95.0|2.9|24.8||||||Week 24: \>=70%||24.8|2.9|
74084505|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|10.6|||||TWO_SIDED|95.0|-0.2|21.0||||||Week 24: \>=70%||21.0|-0.2|
74084506|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.4|||||TWO_SIDED|95.0|-0.7|11.4||||||Week 24: \>=90%||11.4|-0.7|
74084507|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||Week 24: \>=90%||8.5|-2.2|
73847690|NCT01247064|147241119|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
73960332|NCT01378065|147456060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
73960333|NCT01378065|147456061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
73960334|NCT01378065|147456062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|TWO_SIDED||||||t-test, 2 sided|||||||0.034
73960335|NCT01378065|147456063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 6 weeks.||||0.001
73960336|NCT01378065|147456064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 3 months.||||0.004
73960337|NCT01378065|147456065|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 6 months.||||<.001
73960338|NCT01378065|147456066|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 12 months.||||<.001
73960339|NCT00818454|147456113|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||MMRM ANCOVA|||||||<0.0001
73960340|NCT00818454|147456114|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||MMRM ANCOVA|||||||<0.0001
73960341|NCT00818454|147456115|SUPERIORITY_OR_OTHER|||||||0.159|||||||MMRM ANCOVA|||||||0.159
73960342|NCT00818454|147456116|SUPERIORITY_OR_OTHER|||||||0.8278|||||||MMRM ANCOVA|||||||0.8278
73960343|NCT00818454|147456117|SUPERIORITY_OR_OTHER|||||||0.5098|||||||MMRM ANCOVA|||||||0.5098
74084508|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|3.1|30.9||||||Week 40: \>=30%||30.9|3.1|
74084509|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-0.5|||||TWO_SIDED|95.0|-14.8|13.7||||||Week 40: \>=30%||13.7|-14.8|
74084510|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|3.0|31.0||||||Week 40: \>=50%||31.0|3.0|
74084511|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.0|||||TWO_SIDED|95.0|-9.0|18.7||||||Week 40: \>=50%||18.7|-9.0|
74084512|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|4.6|29.4||||||Week 40: \>=70%||29.4|4.6|
74084513|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|7.3|||||TWO_SIDED|95.0|-4.5|18.9||||||Week 40: \>=70%||18.9|-4.5|
74084514|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|7.6|||||TWO_SIDED|95.0|1.4|13.5||||||Week 40: \>=90%||13.5|1.4|
74084515|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.4|||||TWO_SIDED|95.0|-0.1|10.6||||||Week 40: \>=90%||10.6|-0.1|
74084516|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.4|25.8||||||Week 56: \>=30%||25.8|-2.4|
74084517|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-3.8|||||TWO_SIDED|95.0|-17.9|10.5||||||Week 56: \>=30%||10.5|-17.9|
74084518|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.5|25.9||||||Week 56: \>=50%||25.9|-2.5|
74084519|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-2.6|||||TWO_SIDED|95.0|-16.5|11.4||||||Week 56: \>=50%||11.4|-16.5|
74084520|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|18.5|||||TWO_SIDED|95.0|5.6|30.5||||||Week 56: \>=70%||30.5|5.6|
74084521|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.4|||||TWO_SIDED|95.0|-3.6|20.0||||||Week 56: \>=70%||20.0|-3.6|
74084522|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.7|||||TWO_SIDED|95.0|1.6|15.4||||||Week 56: \>=90%||15.4|1.6|
74084523|NCT02725411|147722169|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||Week 56: \>=90%||8.5|-2.2|
74084524|NCT02725411|147722185|OTHER|No formal hypotheses were tested in the study.|Difference in proportion|0.0|||||TWO_SIDED|95.0|-4.1|4.1||||||95% CI of proportion is the Agresti-Coull confidence limit.||4.1|-4.1|
74084525|NCT02725411|147722185|OTHER|No formal hypotheses were tested in the study.|Difference in proportion|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||95% CI of proportion is the Agresti-Coull confidence limit.||8.5|-2.2|
74084526|NCT02911935|147722211|SUPERIORITY||Hazard Ratio (HR)|1.49||||0.08|TWO_SIDED|95.0|0.95|2.34||unadjusted P-value. The threshold for statistical significance was p = 0.05|Log Rank|||The primary analysis tested the statistical null hypothesis of equal recurrent wheeze rates between the azithromycin and placebo groups.||2.34|0.95|0.08
74084527|NCT02911935|147722211|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.11|TWO_SIDED|95.0|0.92|2.29||p-value is adjusted for race, parental history of asthma, ever exposed to smoke and ever exposed to pets. The threshold for statistical significance was p = 0.05|Regression, Cox|||||2.29|0.92|0.11
74084528|NCT02911935|147722212|SUPERIORITY||Hazard Ratio (HR)|1.95||||0.12|TWO_SIDED|95.0|0.83|4.61||Unadjusted. The threshold for statistical significance was p = 0.05|Log Rank|||||4.61|0.83|0.12
74084529|NCT02911935|147722213|SUPERIORITY||Rate Ratio|1.18||||0.31|TWO_SIDED|95.0|0.86|1.62||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||1.62|0.86|0.31
74084530|NCT02911935|147722214|SUPERIORITY||Rate Ratio|1.22||||0.57|TWO_SIDED|95.0|0.6|2.48||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||2.48|0.6|0.57
73899779|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.3412|TWO_SIDED|90.0|0.81|2.17|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 4.||2.17|0.81|0.3412
73899780|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8434|TWO_SIDED|90.0|0.58|1.54|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 5.||1.54|0.58|0.8434
73899781|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0819|TWO_SIDED|90.0|1.03|2.63|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 5.||2.63|1.03|0.0819
73899782|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.2832|TWO_SIDED|90.0|0.44|1.19|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 6.||1.19|0.44|0.2832
73899783|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.0016|TWO_SIDED|90.0|1.54|3.97|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 6.||3.97|1.54|0.0016
73899784|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9727|TWO_SIDED|90.0|0.6|1.63|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 8.||1.63|0.60|0.9727
73899785|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.57||||0.001|TWO_SIDED|90.0|1.6|4.13|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 8.||4.13|1.60|0.0010
73899786|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8312|TWO_SIDED|90.0|0.64|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 10.||1.80|0.64|0.8312
73899787|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06||||0.0002|TWO_SIDED|90.0|1.86|5.02|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 10.||5.02|1.86|0.0002
73899788|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.553|TWO_SIDED|90.0|0.13|2.6|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 1.||2.60|0.13|0.5530
73899789|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.978|TWO_SIDED|90.0|0.28|3.41|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 1.||3.41|0.28|0.9780
73899790|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.8312|TWO_SIDED|90.0|0.43|3.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 2.||3.03|0.43|0.8312
73899791|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.1881|TWO_SIDED|90.0|0.83|5.25|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 2.||5.25|0.83|0.1881
73899792|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.6384|TWO_SIDED|90.0|0.39|1.69|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 3.||1.69|0.39|0.6384
73899793|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.216|TWO_SIDED|90.0|0.84|3.37|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 3.||3.37|0.84|0.2160
73899794|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.0259|TWO_SIDED|90.0|0.2|0.79|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 4.||0.79|0.20|0.0259
73899795|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.3959|TWO_SIDED|90.0|0.39|1.35|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 4.||1.35|0.39|0.3959
73899796|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.3857|TWO_SIDED|90.0|0.39|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 5.||1.34|0.39|0.3857
73899797|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.3126|TWO_SIDED|90.0|0.8|2.52|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 5.||2.52|0.80|0.3126
73899798|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.1182|TWO_SIDED|90.0|0.36|1.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 6.||1.03|0.36|0.1182
73899799|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.0125|TWO_SIDED|90.0|1.29|3.43|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 6.||3.43|1.29|0.0125
73899800|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2147|TWO_SIDED|90.0|0.42|1.13|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 8.||1.13|0.42|0.2147
73899801|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.0783|TWO_SIDED|90.0|1.03|2.69|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 8.||2.69|1.03|0.0783
73899802|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9067||90.0|0.57|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 10.||1.64|0.57|0.9067
73899803|NCT00420641|147330886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0328|TWO_SIDED|90.0|1.15|2.92|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 10.||2.92|1.15|0.0328
74023251|NCT03193866|147599173|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|0.9|4.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.6|0.9|
74023252|NCT03193866|147599173|SUPERIORITY||Mean Difference (Final Values)|2.1|||||TWO_SIDED|95.0|0.2|4.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.0|0.2|
74023253|NCT03878147|147599177|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|2.39|STANDARD_ERROR_OF_MEAN|0.82|<|0.01|TWO_SIDED|95.0|0.78|4.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||4.01|0.78|<.01
74023254|NCT03878147|147599177|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|0.82||0.32|TWO_SIDED|95.0|-0.8|2.44||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||2.44|-0.80|.32
74023255|NCT03878147|147599177|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|0.99||0.07|TWO_SIDED|95.0|-3.74|0.16||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.16|-3.74|.07
74023256|NCT03878147|147599177|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.96||0.83|TWO_SIDED|95.0|-2.1|1.68||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||1.68|-2.10|.83
74023257|NCT03878147|147599178|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.28||0.65|TWO_SIDED|95.0|-0.71|0.42||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.42|-0.71|.65
74023258|NCT03878147|147599178|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Median Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.29||0.95|TWO_SIDED|95.0|-0.54|0.58||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.58|-0.54|.95
74084531|NCT02911935|147722215|SUPERIORITY||Rate Ratio|1.34||||0.38|TWO_SIDED|95.0|0.7|2.57||unadjusted P-value. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||2.57|0.70|0.38
74084532|NCT02911935|147722216|SUPERIORITY||Rate Ratio|0.92||||0.56|TWO_SIDED|95.0|0.7|1.22||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||1.22|0.7|0.56
74084533|NCT04979858|147722234|OTHER|The statistical analysis involved the use of a single-factor ANOVA test to assess the importance of the various factors associated with the design of the Focal Mask (the Treatment) that would impact its performance in reducing the spread of COVID-19, which is caused by the SARS-CoV-2 virus. The Bonferroni t-test was conducted post hoc to assess the statistical significance of the various factors.|||||<|0.01|||||||ANOVA|||||||<0.01
73899804|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6928|TWO_SIDED|90.0|0.44|3.76|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 1.||3.76|0.44|0.6928
73899805|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.3039|TWO_SIDED|90.0|0.69|5.01|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 1.||5.01|0.69|0.3039
73960344|NCT00818454|147456118|SUPERIORITY_OR_OTHER|||||||0.6591|||||||MMRM ANCOVA|||||||0.6591
74084534|NCT03259789|147722261|SUPERIORITY||Difference of LS Means|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-0.32|-0.74|< 0.0001
74084535|NCT03259789|147722263|SUPERIORITY||Difference of LS Means|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.83|-0.86|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-0.86|-1.83|< 0.0001
74084536|NCT03259789|147722265|SUPERIORITY||Difference of LS Means|-7.07|||<|0.0001|TWO_SIDED|95.0|-9.83|-4.32|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-4.32|-9.83|< 0.0001
74084537|NCT03259789|147722266|SUPERIORITY||Odds Ratio (OR)|4.69||||0.0014|TWO_SIDED|95.0|1.7|12.95||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 6 was calculated as the odds ratio of bexagliflozin group over placebo group.||12.95|1.70|0.0014
73960345|NCT00818454|147456119|SUPERIORITY_OR_OTHER|||||||0.3631|||||||MMRM ANCOVA|||||||0.3631
73960346|NCT00818454|147456120|NON_INFERIORITY_OR_EQUIVALENCE|Enter additional comments here, if non-inferiority or equivalence analysis||||||0.6787|||||||MMRM ANCOVA|||||||0.6787
73960347|NCT00818454|147456121|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction||||||0.0001
73899806|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.1938|TWO_SIDED|90.0|0.89|2.7|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 2.||2.70|0.89|0.1938
73899807|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.06|TWO_SIDED|90.0|1.08|3.16|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 2.||3.16|1.08|0.0600
73899808|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8989|TWO_SIDED|90.0|0.61|1.53|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 3.||1.53|0.61|0.8989
73899809|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.0136|TWO_SIDED|90.0|1.25|3.05|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 3.||3.05|1.25|0.0136
73899810|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.3099|TWO_SIDED|90.0|0.5|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 4.||1.18|0.50|0.3099
73899811|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1137|TWO_SIDED|90.0|0.98|2.27|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 4.||2.27|0.98|0.1137
73960348|NCT00818454|147456122|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction||||||0.0003
73960349|NCT02296424|147456137|EQUIVALENCE|nominal 2.5% two-sided significance level was expected to have 90% powe to detect a difference between the Null Hypothesis proportion of patients who remain at their dose level.||||||0.0001|||||||exact binomial test|||||||0.0001
73960350|NCT00807144|147456140|SUPERIORITY|||||||0.26|||||||Log Rank|||||||0.26
73899812|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8682||90.0|0.67|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 5.||1.64|0.67|0.8682
73899813|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56||||0.0006|TWO_SIDED|90.0|1.63|4.03|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 5.||4.03|1.63|0.0006
73899814|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.8992|TWO_SIDED|90.0|0.62|1.51|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 6.||1.51|0.62|0.8992
73960351|NCT00807144|147456141|SUPERIORITY|||||||0.48|||||||Log Rank|||Year 1||||0.48
73960352|NCT00807144|147456141|SUPERIORITY|||||||0.75|||||||Log Rank|||Year 2||||0.75
73960353|NCT00854906|147456143|NON_INFERIORITY_OR_EQUIVALENCE|This was a pilot study. Therefore, no formal power analyses were performed.|Mean Difference (Final Values)|0.666|STANDARD_DEVIATION|3.6||0.074|TWO_SIDED|95.0|-0.069|1.401|||t-test, 2 sided|||The paired T-test was used to compare mean KTBUT and mean FTBUT.||1.401|-0.069|0.074
73960354|NCT00854906|147456144|NON_INFERIORITY_OR_EQUIVALENCE|The analysis will evaluate the association between OSDI with KTBUT.|Pearson's Correlation, r|-0.34||||0.093|ONE_SIDED||||||Pearson's correlation|||A correlation was performed between ODSI questionnaire results and each participant's KTBUT.||||0.093
73960355|NCT00854906|147456144|SUPERIORITY_OR_OTHER||Pearson's Correlation, r|-0.26||||0.216|||||||Pearson's Correlation|||A correlation was performed between ODSI questionnaire results and each participant's FTBUT.||||0.216
73971022|NCT04119843|147482207|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|0.622|<|0.001|TWO_SIDED|95.0|0.494|0.813|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 3||0.813|0.494|<0.001
74023259|NCT03878147|147599178|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Median Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.34|TWO_SIDED|95.0|-0.92|0.13||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.13|-0.92|.34
74084538|NCT03259789|147722266|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0001|TWO_SIDED|95.0|1.96|8.92||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 12 was calculated as the odds ratio of bexagliflozin group over placebo group.||8.92|1.96|0.0001
74084539|NCT03259789|147722266|SUPERIORITY||Odds Ratio (OR)|2.57||||0.003|TWO_SIDED|95.0|1.31|5.04||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 18 was calculated as the odds ratio of bexagliflozin group over placebo group.||5.04|1.31|0.0030
74084540|NCT03259789|147722266|SUPERIORITY||Odds Ratio (OR)|3.88|||<|0.0001|TWO_SIDED|95.0|1.99|7.58||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 24 was calculated as the odds ratio of bexagliflozin group over placebo group.||7.58|1.99|< 0.0001
74084541|NCT03259789|147722268|SUPERIORITY||Difference of LS Means|-2.51|||<|0.0001|TWO_SIDED|95.0|-3.45|-1.57|||ANCOVA|ANCOVA analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-1.57|-3.45|< 0.0001
74084542|NCT03259789|147722270|SUPERIORITY||Difference of LS Means|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.38||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 6 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.38|-0.74|< 0.0001
74084543|NCT03259789|147722270|SUPERIORITY||Difference of LS Means|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.86|-0.46||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 12 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.46|-0.86|< 0.0001
74084544|NCT03259789|147722270|SUPERIORITY||Difference of LS Means|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.3||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 18 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.30|-0.69|< 0.0001
74084545|NCT03259789|147722270|SUPERIORITY||Difference of LS Means|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 24 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.32|-0.74|< 0.0001
74084546|NCT02063217|147722272|SUPERIORITY|Mixed linear models|Mean Difference (Net)|17.0||||0.07|TWO_SIDED|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean (standard error), units = %. 17(7.2) increase in overnight amyloid-beta 40 concentrations over waking baseline between the sleep deprivation group and controls.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.||||0.07
74084547|NCT02063217|147722272|SUPERIORITY|Mixed linear models|Mean Difference (Net)|7.0||||1|TWO_SIDED|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean= 7%, standard error = 7.6%. 7% increase in overnight amyloid beta 40 concentrations over the waking baseline between the sleep induction group and control group.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.||||1.0
74084548|NCT01160640|147722294|SUPERIORITY_OR_OTHER|||||||0.046||||||P-value for proportion of women who had clearance of anaerobic organisms from the endometrium at the 30-day visit|Fisher Exact|||||||0.046
74084549|NCT01160640|147722296|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value for proportion of women who did not have M. genitalium detected in the cervix or endometrium at the 30-day visit|Fisher Exact|||||||0.16
74084550|NCT01160640|147722297|SUPERIORITY_OR_OTHER|||||||0.74||||||P-value for proportion of women who experienced resolution of clinical signs and symptoms of PID at the 3-day visit|Fisher Exact|||||||0.74
74084551|NCT00178711|147722314|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||=|0.67|TWO_SIDED|95.0|0.76|1.53|||Regression, Logistic|||The primary hypothesis was a two-sided test assessing whether the induction of hypothermia modified the percentage of subjects with poor outcomes at 6 months after injury. Percentages in each group were compared using a generalized linear model with a binomial distribution and log link function, logistic regression model with admission age and baseline GCS as covariates.||1.53|0.76|=0.67
74023260|NCT03878147|147599178|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.33||0.81|TWO_SIDED|95.0|-0.73|0.58||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.58|-0.73|.81
74023261|NCT03878147|147599179|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Median Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.01|TWO_SIDED|95.0|0.004|0.043||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.043|0.004|.01
74023262|NCT03878147|147599179|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|0.003|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.040|0.003|.02
74023263|NCT03878147|147599179|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.19|TWO_SIDED|95.0|-0.01|0.05||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.05|-0.01|.19
74023264|NCT03878147|147599179|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.19|TWO_SIDED|95.0|-0.01|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.04|-0.01|.19
74084552|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|51.08|||||TWO_SIDED|95.0|35.22|74.08||||||TAK-272F: Least square mean (LS) mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95 percent (%) confidence intervals (CI) were calculated using an analysis of variance (ANOVA) model for natural log-transformed data.||74.08|35.22|
74084553|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|117.95|||||TWO_SIDED|95.0|81.32|171.07||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.07|81.32|
74084554|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|272.87|||||TWO_SIDED|95.0|188.14|395.76||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||395.76|188.14|
74084555|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|183.27|||||TWO_SIDED|95.0|126.36|265.81||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||265.81|126.36|
74084556|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|101.67|||||TWO_SIDED|95.0|68.95|149.9||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||149.90|68.95|
74084557|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.98|||||TWO_SIDED|95.0|92.23|200.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||200.50|92.23|
74084558|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|62.34|||||TWO_SIDED|95.0|36.17|107.45||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||107.45|36.17|
74084559|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|93.2|||||TWO_SIDED|95.0|54.08|160.64||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||160.64|54.08|
74084560|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|274.21|||||TWO_SIDED|95.0|159.1|472.63||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||472.63|159.10|
73899815|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.0004|TWO_SIDED|90.0|1.67|4.09|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 6.||4.09|1.67|0.0004
74084561|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|261.12|||||TWO_SIDED|95.0|151.5|450.05||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||450.05|151.50|
74084562|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|112.47|||||TWO_SIDED|95.0|69.34|182.41||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||182.41|69.34|
74084563|NCT02367872|147722341|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|176.75|||||TWO_SIDED|95.0|108.97|286.67||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||286.67|108.97|
74084564|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|57.36|||||TWO_SIDED|95.0|37.76|87.14||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||87.14|37.76|
74084565|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|77.04|||||TWO_SIDED|95.0|50.72|117.03||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||117.03|50.72|
74084566|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|206.41|||||TWO_SIDED|95.0|135.88|313.54||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||313.54|135.88|
74084567|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|143.11|||||TWO_SIDED|95.0|94.21|217.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||217.39|94.21|
74084568|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|85.31|||||TWO_SIDED|95.0|51.03|142.61||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||142.61|51.03|
74084569|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|131.63|||||TWO_SIDED|95.0|78.74|220.04||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||220.04|78.74|
74084570|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|70.38|||||TWO_SIDED|95.0|40.42|122.53||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||122.53|40.42|
74084571|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|55.03|||||TWO_SIDED|95.0|31.61|95.81||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||95.81|31.61|
74084572|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|125.96|||||TWO_SIDED|95.0|72.35|219.3||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||219.30|72.35|
74084573|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|103.93|||||TWO_SIDED|95.0|59.7|180.95||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||180.95|59.70|
74084574|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|91.97|||||TWO_SIDED|95.0|49.45|171.06||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.06|49.45|
73899816|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.28|TWO_SIDED|90.0|0.85|2.23|||Placebo versus GSK372475 in percentage o|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 8.||2.23|0.85|0.2800
73899817|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69||||0|TWO_SIDED|90.0|2.24|6.08|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 8.||6.08|2.24|0.0000
73899818|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.0507|TWO_SIDED|90.0|1.1|3.13|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 10.||3.13|1.10|0.0507
74084575|NCT02367872|147722342|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|139.33|||||TWO_SIDED|95.0|74.91|259.15||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||259.15|74.91|
74084576|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|51.39|||||TWO_SIDED|95.0|35.45|74.49||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||74.49|35.45|
74084577|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|118.43|||||TWO_SIDED|95.0|81.7|171.68||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.68|81.70|
74084578|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|272.83|||||TWO_SIDED|95.0|188.21|395.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||395.50|188.21|
74084579|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|184.13|||||TWO_SIDED|95.0|127.02|266.91||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||266.91|127.02|
74084580|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|101.64|||||TWO_SIDED|95.0|69.04|149.64||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||149.64|69.04|
73899819|NCT00420641|147330887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97||||0.0003|TWO_SIDED|90.0|1.81|4.88|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 10.||4.88|1.81|0.0003
74023265|NCT05817045|147599180|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.01||||0.948|TWO_SIDED|95.0|0.777|1.31|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent recurrence or disease progression (until the end of the study) Full Analysis Set (FAS)||1.310|0.777|0.948
74023266|NCT05817045|147599180|SUPERIORITY|Per-Protocol Population|Hazard Ratio (HR)|1.02||||0.902|TWO_SIDED|95.0|0.774|1.337||adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score.|NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) Per-Protocol Population||1.337|0.774|0.902
74084581|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|136.59|||||TWO_SIDED|95.0|92.78|201.09||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||201.09|92.78|
74084582|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|59.17|||||TWO_SIDED|95.0|33.99|102.99||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||102.99|33.99|
74084583|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|97.04|||||TWO_SIDED|95.0|55.75|168.9||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||168.90|55.75|
74084584|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|260.03|||||TWO_SIDED|95.0|149.39|452.6||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||452.60|149.39|
74084585|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|319.06|||||TWO_SIDED|95.0|183.31|555.34||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||555.34|183.31|
74084586|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|130.07|||||TWO_SIDED|95.0|81.66|207.18||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.18|81.66|
74084587|NCT02367872|147722343|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|192.63|||||TWO_SIDED|95.0|120.94|306.83||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||306.83|120.94|
74084588|NCT02367872|147722344|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|60.22|||||TWO_SIDED|95.0|40.05|90.56||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||90.56|40.05|
73899820|NCT00420641|147330888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8782|TWO_SIDED|90.0|0.62|1.5|||Regression, Logistic|||Placebo versus GSK372475 in percentage of participants Satisfied with Study Medication at Week 10.||1.50|0.62|0.8782
73899821|NCT00420641|147330888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.0011|TWO_SIDED|90.0|1.56|3.86|||Regression, Logistic|||Placebo versus Paroxetine in percentage of participants Satisfied with Study Medication at Week 10.||3.86|1.56|0.0011
73899822|NCT02815280|147330893|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|1.12||0.0051|TWO_SIDED|95.0|0.95|5.35|||ANCOVA|||Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, baseline inflammatory lesion count and pooled investigational site as a blocking factor.||5.35|0.95|0.0051
73899823|NCT02815280|147330894|SUPERIORITY|P-value is for the null hypothesis that the combined log (Risk Ratio) equals 0.|Risk ratio|1.88|STANDARD_ERROR_OF_MEAN|0.31||0.0424|TWO_SIDED|95.0|1.02|3.46|||Mantel Haenszel|||||3.46|1.02|0.0424
73899824|NCT02815280|147330895|SUPERIORITY||Mean Difference (Final Values)|12.84|STANDARD_ERROR_OF_MEAN|5.3||0.0155|TWO_SIDED|95.0|2.44|23.23||Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.|ANCOVA|||||23.23|2.44|0.0155
73899825|NCT02815280|147330896|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.89|STANDARD_ERROR_OF_MEAN|1.03||0.0001|TWO_SIDED|95.0|1.88|5.9|||ANCOVA|||||5.90|1.88|0.0001
73899826|NCT02815280|147330896|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.78|STANDARD_ERROR_OF_MEAN|1.11||0.0007|TWO_SIDED|95.0|1.6|5.95|||ANCOVA|||||5.95|1.60|0.0007
74084589|NCT02367872|147722344|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|97.39|||||TWO_SIDED|95.0|64.77|146.46||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||146.46|64.77|
74084590|NCT02367872|147722344|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|111.6|||||TWO_SIDED|95.0|74.21|167.82||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||167.82|74.21|
74084591|NCT02367872|147722344|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|138.79|||||TWO_SIDED|95.0|92.29|208.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||208.70|92.29|
73899827|NCT02815280|147330897|SUPERIORITY|P-value is for the null hypothesis that the combined log (Risk Ratio) equals 0. Percentage of participants achieving IGA treatment success at Week 6.|Risk Difference (RD)|3.87|STANDARD_ERROR_OF_MEAN|1.44||0.0071|TWO_SIDED|95.0|1.06|6.69|||Cochran-Mantel-Haenszel|||||6.69|1.06|0.0071
73899828|NCT02815280|147330897|SUPERIORITY||Risk Difference (RD)|1.64|STANDARD_ERROR_OF_MEAN|2.52||0.5143|TWO_SIDED|95.0|-3.3|6.58|||Cochran-Mantel-Haenszel|||||6.58|-3.30|0.5143
73899829|NCT00603642|147330903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73899830|NCT00603642|147330904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73899831|NCT00603642|147330905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||ANCOVA|||||||0.0003
73899832|NCT00603642|147330906|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73960356|NCT03622580|147456173|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|97.5|-2.0|1.6|||||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||1.6|-2.0|
73899833|NCT00603642|147330907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6015|||||||Fisher Exact|||||||0.6015
73899834|NCT02514473|147330923|SUPERIORITY||Least Square (LS) Mean Difference|-1.09|||<|0.0001|TWO_SIDED|95.0|-1.43|-0.75|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM). The model included treatment, visit and treatment-by-visit interaction as fixed effects; and participant as a random effect with adjustments for baseline, weight (less than \[\<\] 25 kilogram \[kg\] versus greater than or equal to \[\>=\] 25 kg) and percent predicted forced expiratory volume in 1 second (FEV1) severity (\<90 versus \>=90) at screening.||-0.75|-1.43|< 0.0001
73899835|NCT01431300|147330955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.0|STANDARD_DEVIATION|12.0|<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||signal-to-noise (SNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.||||<0.01
73899836|NCT01431300|147330955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.0|STANDARD_DEVIATION|19.0|<|0.01||95.0|||||t-test, 2 sided|||contrast-to-noise (CNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.||||<0.01
73899837|NCT06054269|147330956|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.004
73971023|NCT04119843|147482208|SUPERIORITY|Reader success of the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.98|STANDARD_DEVIATION|0.853|<|0.001|TWO_SIDED|95.0|0.759|1.196|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 1||1.196|0.759|<0.001
74084592|NCT02367872|147722344|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.18|||||TWO_SIDED|95.0|87.91|207.87||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.87|87.91|
73899838|NCT06054269|147330956|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.066
73899839|NCT06054269|147330956|SUPERIORITY|||||||0.694|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.694
73899840|NCT06054269|147330956|SUPERIORITY|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.408
73899841|NCT06054269|147330957|SUPERIORITY|||||||0.164|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.164
73899842|NCT06054269|147330957|SUPERIORITY|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.113
73899843|NCT06054269|147330957|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.404
73899844|NCT06054269|147330957|SUPERIORITY|||||||0.879|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.879
73899845|NCT06054269|147330958|SUPERIORITY||||||<|0.001|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||<0.001
73899846|NCT06054269|147330958|SUPERIORITY|||||||0.002|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.002
73899847|NCT06054269|147330958|SUPERIORITY|||||||0.468|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.468
73899848|NCT06054269|147330958|SUPERIORITY|||||||0.057|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.057
74023267|NCT05817045|147599180|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.02||||0.859|TWO_SIDED|95.0|0.782|1.342|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) - Secondary Analysis (FAS excluding subjects that were qPCR negative at baseline)||1.342|0.782|0.859
74023268|NCT05817045|147599182|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.29||||0.017|TWO_SIDED|95.0|1.047|1.596|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virologic rebound (during the subject's remaining time on study) Full Analysis Set (FAS)||1.596|1.047|0.017
74084593|NCT02367872|147722344|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|323.75|||||TWO_SIDED|95.0|210.54|497.85||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||497.85|210.54|
74084594|NCT02367872|147722345|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|67.61|||||TWO_SIDED|95.0|42.17|108.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||108.39|42.17|
74084595|NCT02367872|147722345|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|63.7|||||TWO_SIDED|95.0|39.73|102.12||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||102.12|39.73|
74084596|NCT02367872|147722345|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|84.45|||||TWO_SIDED|95.0|52.67|135.38||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||135.38|52.67|
74084597|NCT02367872|147722345|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|108.54|||||TWO_SIDED|95.0|67.7|174.01||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||174.01|67.70|
74084598|NCT02367872|147722345|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|113.25|||||TWO_SIDED|95.0|69.62|184.24||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||184.24|69.62|
74084599|NCT02367872|147722345|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|312.89|||||TWO_SIDED|95.0|192.34|509.0||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||509.00|192.34|
73847691|NCT04828707|147241125|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||"The Intent-To-Treat (ITT) dataset was used for primary outcome. To overcome impact of missing data, statistical analysis was conducted using the Last Observation Carried Forward (LOCF) as an imputation method.~The data of each variable collected from the daily diary was normalized to 28 days for every period (weeks 1-4, weeks 5-8, and weeks 9-12).~Participants' data who entered the treatment phase but dropped out during weeks 5-8 were carried forward and analyzed as their data at weeks 9-12."||||<0.05
73847692|NCT00523978|147241151|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||The null hypothesis is the success rate in experimental group is less than and equal to the one in control group. This comparison of the rates was performed using a 2-sided Fisher's Exact. A sample size of 240(160 experimental and 80 control) is required to provide 80% power to detect the treatment difference using a 2-sided (alpha = 0.05)Fisher's Exact Test of binomial proportions assuming the success rate was 40% for control and 60% for treatment.||||<0.0001
73899849|NCT06054269|147330959|SUPERIORITY|||||||0.112|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.112
74084600|NCT02367872|147722346|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|60.68|||||TWO_SIDED|95.0|40.35|91.27||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||91.27|40.35|
74084601|NCT02367872|147722346|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|98.01|||||TWO_SIDED|95.0|65.17|147.41||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||147.41|65.17|
73899850|NCT06054269|147330959|SUPERIORITY|||||||0.149|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.149
73899851|NCT06054269|147330959|SUPERIORITY|||||||0.101|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.101
74084602|NCT02367872|147722346|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|111.68|||||TWO_SIDED|95.0|74.25|167.96||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||167.96|74.25|
74084603|NCT02367872|147722346|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|139.7|||||TWO_SIDED|95.0|92.88|210.11||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||210.11|92.88|
74084604|NCT02367872|147722346|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.08|||||TWO_SIDED|95.0|87.75|207.92||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.92|87.75|
74084605|NCT02367872|147722346|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|325.28|||||TWO_SIDED|95.0|211.32|500.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||500.70|211.32|
74084606|NCT02625298|147722358|OTHER||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
74023269|NCT05817045|147599182|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.33||||0.014|TWO_SIDED|95.0|1.059|1.665|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (Per-Protocol population)||1.665|1.059|0.014
73899852|NCT06054269|147330959|SUPERIORITY|||||||0.259|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.259
73899853|NCT06054269|147330960|SUPERIORITY|||||||0.097|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.097
73899854|NCT06054269|147330960|SUPERIORITY|||||||0.733|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.733
73899855|NCT06054269|147330960|SUPERIORITY|||||||0.477|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.477
73899856|NCT06054269|147330960|SUPERIORITY|||||||0.312|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.312
73899857|NCT06054269|147330961|SUPERIORITY|||||||0.22|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.220
73899858|NCT06054269|147330961|SUPERIORITY|||||||0.003|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.003
73899859|NCT06054269|147330961|SUPERIORITY|||||||0.897|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.897
73899860|NCT06054269|147330961|SUPERIORITY|||||||0.931|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.931
73899861|NCT03836001|147330991|SUPERIORITY|||||||0.59||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||0.59
73899862|NCT03836001|147330992|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
73899863|NCT03836001|147330993|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
73899864|NCT03836001|147330994|SUPERIORITY|||||||0.67||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||0.67
73899865|NCT03836001|147330995|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
73899866|NCT03836001|147330996|OTHER||Mean Difference (Net)|-0.11||||0.09|TWO_SIDED|95.0|-0.24|0.02||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||0.02|-0.24|0.09
73899867|NCT03836001|147330997|SUPERIORITY||Mean Difference (Net)|-0.08||||0.16|TWO_SIDED|95.0|-0.19|0.03||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||0.03|-0.19|0.16
73899868|NCT03836001|147330999|OTHER||Mean Difference (Net)|-0.25||||0.002|TWO_SIDED|95.0|-0.41|-0.09||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||-0.09|-0.41|0.002
73899869|NCT04268823|147331069|SUPERIORITY||Least Squares mean|-0.203|STANDARD_ERROR_OF_MEAN|0.1938||0.298|TWO_SIDED|80.0|-0.524|0.119|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.119|-0.524|0.298
73899870|NCT04268823|147331070|SUPERIORITY||Least Squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.651|TWO_SIDED|80.0|-0.9|0.5|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.5|-0.9|0.651
73899871|NCT04268823|147331071|SUPERIORITY||Least Squares mean|-1.39|STANDARD_ERROR_OF_MEAN|1.29||0.288|TWO_SIDED|80.0|-3.55|0.78|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.78|-3.55|0.288
73899872|NCT04268823|147331072|SUPERIORITY||Least Squares mean|4.2|STANDARD_ERROR_OF_MEAN|4.336||0.338|TWO_SIDED|80.0|-3.09|11.48|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||11.48|-3.09|0.338
73899873|NCT04268823|147331073|SUPERIORITY||Least Squares mean|-0.82|STANDARD_ERROR_OF_MEAN|3.147||0.795|TWO_SIDED|80.0|-6.05|4.42|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Total score||4.42|-6.05|0.795
73899874|NCT04268823|147331073|SUPERIORITY||Least Squares mean|5.75|STANDARD_ERROR_OF_MEAN|4.155||0.17|TWO_SIDED|80.0|-1.16|12.66|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Symptoms score||12.66|-1.16|0.170
73899875|NCT04268823|147331073|SUPERIORITY||Least Squares mean|-0.61|STANDARD_ERROR_OF_MEAN|3.259||0.851|TWO_SIDED|80.0|-6.02|4.8|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Activity score||4.80|-6.02|0.851
73899876|NCT04268823|147331073|SUPERIORITY||Least Squares mean|-2.07|STANDARD_ERROR_OF_MEAN|4.035||0.61|TWO_SIDED|80.0|-8.78|4.65|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Impact score||4.65|-8.78|0.610
73899877|NCT04268823|147331074|SUPERIORITY||Least Squares mean|0.25|STANDARD_ERROR_OF_MEAN|4.557||0.956|TWO_SIDED|80.0|-7.3|7.8|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Cough symptom score||7.80|-7.30|0.956
73899878|NCT04268823|147331074|SUPERIORITY||Least Squares mean|4.22|STANDARD_ERROR_OF_MEAN|4.671||0.369|TWO_SIDED|80.0|-3.55|11.99|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Sputum symptom score||11.99|-3.55|0.369
73960357|NCT03622580|147456173|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|97.5|-1.1|2.5|||||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.5|-1.1|
73960358|NCT03622580|147456173|SUPERIORITY||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.95||0.4699|TWO_SIDED|97.5|-2.8|1.4||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||1.4|-2.8|0.4699
73960359|NCT03622580|147456173|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.94||0.965|TWO_SIDED|97.5|-2.1|2.2||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||2.2|-2.1|0.9650
73960360|NCT03622580|147456173|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79||0.7967|TWO_SIDED|97.5|-2.0|1.6||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||1.6|-2.0|0.7967
73960361|NCT03622580|147456173|SUPERIORITY||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.79||0.3772|TWO_SIDED|97.5|-1.1|2.5||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.5|-1.1|0.3772
73960362|NCT03622580|147456174|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -10%, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W.|Difference in CMH Weighted Percentage|10.2|||||TWO_SIDED|97.5|0.3|20.0||||||The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||20.0|0.3|
73960363|NCT03622580|147456174|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -10%, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W.|Difference in CMH Weighted Percentage|6.1|||||TWO_SIDED|97.5|-3.6|15.8||||||The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||15.8|-3.6|
73960364|NCT03622580|147456174|SUPERIORITY||Difference in CMH Weighted Percentage|7.2||||0.1761|TWO_SIDED|97.5|-4.6|18.9||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||18.9|-4.6|0.1761
73960365|NCT03622580|147456174|SUPERIORITY||Difference in CMH Weighted Percentage|4.8||||0.3539|TWO_SIDED|97.5|-6.7|16.3||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||16.3|-6.7|0.3539
73960366|NCT03622580|147456174|SUPERIORITY||Difference in CMH Weighted Percentage|10.2||||0.0237|TWO_SIDED|97.5|0.3|20.0||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||20.0|0.3|0.0237
73960367|NCT03622580|147456174|SUPERIORITY||Difference in CMH Weighted Percentage|6.1||||0.1677|TWO_SIDED|97.5|-3.6|15.8||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||15.8|-3.6|0.1677
73960368|NCT03622580|147456177|OTHER||Difference in CMH Weighted Percentage|-2.6|||||TWO_SIDED|95.0|-10.0|4.9||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.9|-10.0|
73960369|NCT03622580|147456177|OTHER||Difference in CMH Weighted Percentage|3.5|||||TWO_SIDED|95.0|-4.0|11.1||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||11.1|-4.0|
73960370|NCT03622580|147456177|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-8.6|7.9||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||7.9|-8.6|
73960371|NCT03622580|147456177|OTHER||Difference in CMH Weighted Percentage|0.7|||||TWO_SIDED|95.0|-7.4|8.8||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||8.8|-7.4|
73960372|NCT03622580|147456177|OTHER||Difference in CMH Weighted Percentage|-2.5|||||TWO_SIDED|95.0|-9.1|4.1||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.1|-9.1|
73960373|NCT03622580|147456177|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-8.5|4.5||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.5|-8.5|
73960374|NCT03622580|147456177|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-4.6|4.8||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.8|-4.6|
73960375|NCT03622580|147456177|OTHER||Difference in CMH Weighted Percentage|3.3|||||TWO_SIDED|95.0|-1.0|7.5||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||7.5|-1.0|
73899879|NCT04268823|147331074|SUPERIORITY||Least Squares mean|2.03|STANDARD_ERROR_OF_MEAN|4.001||0.613|TWO_SIDED|80.0|-4.61|8.68|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Cough impact score||8.68|-4.61|0.613
73899880|NCT04268823|147331074|SUPERIORITY||Least Squares mean|0.94|STANDARD_ERROR_OF_MEAN|4.518||0.835|TWO_SIDED|80.0|-6.58|8.47|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Sputum impact score||8.47|-6.58|0.835
73899881|NCT04268823|147331076|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.335|TWO_SIDED|80.0|0.0|0.1|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.1|0.0|0.335
73899882|NCT04268823|147331077|SUPERIORITY||Least Squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.645|TWO_SIDED|80.0|-0.1|0.1|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.1|-0.1|0.645
73960376|NCT03622580|147456182|OTHER||Difference in CMH Weighted Percentage|-5.2|||||TWO_SIDED|95.0|-14.0|3.5||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||3.5|-14.0|
73960377|NCT03622580|147456182|OTHER||Difference in CMH Weighted Percentage|1.7|||||TWO_SIDED|95.0|-7.0|10.3||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||10.3|-7.0|
74084607|NCT01074008|147722412|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
73960378|NCT03622580|147456182|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-9.5|9.5||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||9.5|-9.5|
73960379|NCT03622580|147456182|OTHER||Difference in CMH Weighted Percentage|2.1|||||TWO_SIDED|95.0|-7.1|11.3||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||11.3|-7.1|
73960380|NCT03622580|147456182|OTHER||Difference in CMH Weighted Percentage|-4.5|||||TWO_SIDED|95.0|-11.9|2.9||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.9|-11.9|
73960381|NCT03622580|147456182|OTHER||Difference in CMH Weighted Percentage|-7.2|||||TWO_SIDED|95.0|-14.6|0.2||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||0.2|-14.6|
73960382|NCT03622580|147456182|OTHER||Difference in CMH Weighted Percentage|-0.2|||||TWO_SIDED|95.0|-5.5|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||5.2|-5.5|
74084608|NCT01074008|147722412|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
73899883|NCT04268823|147331078|SUPERIORITY||Least Squares mean|2.1|STANDARD_ERROR_OF_MEAN|0.8||0.01|TWO_SIDED|80.0|0.8|3.4|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||3.4|0.8|0.010
73960383|NCT03622580|147456182|OTHER||Difference in CMH Weighted Percentage|2.0|||||TWO_SIDED|95.0|-3.0|7.0||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||7.0|-3.0|
73960384|NCT03622580|147456187|OTHER||Difference in CMH Weighted Percentage|-0.8|||||TWO_SIDED|95.0|-2.8|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||1.3|-2.8|
73899884|NCT01949337|147331087|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.33|TWO_SIDED|95.0|0.8|1.08|||Log Rank|||||1.08|0.80|0.33
73899885|NCT02519855|147331094|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported a conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.87|||<|0.001|TWO_SIDED|95.0|0.8|0.95|||Longitudinal regression model|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||0.95|0.80|<0.001
73960385|NCT03622580|147456187|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.2|1.5||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.5|-2.2|
73960386|NCT03622580|147456187|OTHER||Difference in CMH Weighted Percentage|-1.8|||||TWO_SIDED|95.0|-4.6|0.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||0.9|-4.6|
73960387|NCT03622580|147456187|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.2|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.2|
73899886|NCT02519855|147331095|SUPERIORITY_OR_OTHER||GMFR from Baseline|1.9|||<|0.001|TWO_SIDED|95.0|1.76|2.05||A lower bound of the 95% CI on the GMFR \> 1.4 indicated that the Concomitant Group induces an acceptable VZV antibody response. A p-value ≤0.025 also supported this conclusion.|Longitudinal regression||Estimated GMFR, 95% CI and p-value were based on a longitudinal regression model adjusting for age.|||2.05|1.76|<0.001
73899887|NCT02519855|147331096|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.18|0.88|<0.001
73899888|NCT02519855|147331097|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.1|||<|0.001|TWO_SIDED|95.0|0.94|1.29|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.29|0.94|<0.001
73899889|NCT02519855|147331098|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.0|||<|0.001|TWO_SIDED|95.0|0.88|1.14|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.14|0.88|<0.001
73899890|NCT02519855|147331099|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.99|||<|0.001|TWO_SIDED|95.0|0.87|1.13|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.13|0.87|<0.001
73899891|NCT02415842|147331250|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.12|||||TWO_SIDED|95.0|0.73|1.72|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.72|0.73|
73899892|NCT02415842|147331250|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.23|||||TWO_SIDED|95.0|0.83|1.81|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.81|0.83|
73899893|NCT02415842|147331250|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|0.88|||||TWO_SIDED|95.0|0.63|1.24|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.24|0.63|
73899894|NCT02415842|147331251|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 21 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.66|||||TWO_SIDED|95.0|1.12|2.47|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.47|1.12|
73899895|NCT02415842|147331251|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|2.16|||||TWO_SIDED|95.0|1.54|3.03|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||3.03|1.54|
73899896|NCT02415842|147331251|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.95|||||TWO_SIDED|95.0|1.49|2.54|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.54|1.49|
73960388|NCT03622580|147456187|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-4.5|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.2|-4.5|
73960389|NCT03622580|147456187|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-2.6|3.4||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||3.4|-2.6|
73899897|NCT02415842|147331251|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 385 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.63|||||TWO_SIDED|95.0|1.32|2.01|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.01|1.32|
73960390|NCT03622580|147456191|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-3.5|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||1.3|-3.5|
73960391|NCT03622580|147456191|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-3.1|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.3|-3.1|
73960392|NCT03622580|147456191|OTHER||Difference in CMH Weighted Percentage|-2.1|||||TWO_SIDED|95.0|-5.1|0.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||0.9|-5.1|
73960393|NCT03622580|147456191|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-3.5|1.6||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.6|-3.5|
74084609|NCT01074008|147722412|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
74084610|NCT01074008|147722412|SUPERIORITY_OR_OTHER|||||||0.009||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.009
74084611|NCT01074008|147722412|SUPERIORITY_OR_OTHER|||||||0.012||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.012
74084612|NCT01074008|147722412|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
73960394|NCT03622580|147456191|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-5.2|2.8||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.8|-5.2|
73960395|NCT03622580|147456191|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-4.1|3.3||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||3.3|-4.1|
74084613|NCT01074008|147722412|SUPERIORITY_OR_OTHER|||||||0.032||||||There was no adjustment for multiple comparisons and the pre-specified, 2-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight subjects per ABT-333 group and 11 subjects in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a 2-sided 2-sample t-test with a significance level of 0.05.||||0.032
74084614|NCT01074008|147722412|SUPERIORITY_OR_OTHER|||||||0.053||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-333 group and 11 participants in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.053
74084615|NCT01074008|147722413|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.001
74084616|NCT01074008|147722413|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.006
74084617|NCT01074008|147722413|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||<0.001
74084618|NCT01074008|147722413|SUPERIORITY_OR_OTHER|||||||0.262|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.262
74084619|NCT01074008|147722413|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||1.000
74084620|NCT01074008|147722413|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.245
73960396|NCT03622580|147456195|OTHER||Difference in CMH Weighted Percentage|-4.9|||||TWO_SIDED|95.0|-12.6|2.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.9|-12.6|
73960397|NCT03622580|147456195|OTHER||Difference in CMH Weighted Percentage|2.0|||||TWO_SIDED|95.0|-5.9|9.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.8|-5.9|
74084621|NCT01074008|147722413|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.111
74084622|NCT01074008|147722413|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.111
74084623|NCT01074008|147722414|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
74084624|NCT01074008|147722414|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.059
74084625|NCT01074008|147722414|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
74084626|NCT01074008|147722414|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
74084627|NCT01074008|147722414|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.370
74084628|NCT01074008|147722414|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
73899898|NCT02415842|147331252|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.39|||||TWO_SIDED|95.0|1.14|1.69|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.69|1.14|
73899899|NCT02415842|147331252|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.49|||||TWO_SIDED|95.0|1.28|1.73|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.73|1.28|
73899900|NCT02415842|147331252|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.2|||||TWO_SIDED|95.0|1.0|1.44|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.44|1.00|
73960398|NCT03622580|147456195|OTHER||Difference in CMH Weighted Percentage|-8.6|||||TWO_SIDED|95.0|-17.8|0.5||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.5|-17.8|
74084629|NCT01074008|147722414|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
74084630|NCT01074008|147722414|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
74084631|NCT01074008|147722427|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
74084632|NCT01074008|147722427|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
74084633|NCT01074008|147722427|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||<0.001
74084634|NCT01074008|147722427|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.024
74084635|NCT01074008|147722427|SUPERIORITY_OR_OTHER|||||||0.319|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.319
74084636|NCT01074008|147722427|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
74084637|NCT01074008|147722427|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
74084638|NCT01074008|147722427|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.074
73899901|NCT02415842|147331253|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|10.79|||||TWO_SIDED|95.0|-16.5|36.83|||Asymptotic standardized 95% CI|||||36.83|-16.50|
73899902|NCT02415842|147331253|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|12.0|||||TWO_SIDED|95.0|-14.45|36.98|||Asymptotic standardized 95% CI|||||36.98|-14.45|
74084639|NCT00578968|147722436|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||||||0.01
74084640|NCT00578968|147722437|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74084641|NCT00578968|147722438|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74084642|NCT00578968|147722439|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74084643|NCT00578968|147722440|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||Comparison between the two groups at baseline resting.||||0.13
74084644|NCT00578968|147722440|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANOVA|||Comparison was made between the two groups at baseline peak exercise||||<0.01
74084645|NCT00578968|147722441|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74084646|NCT00578968|147722442|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
74084647|NCT00578968|147722443|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
74084648|NCT00578968|147722444|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||||||0.01
74084649|NCT00578968|147722445|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
74084650|NCT00578968|147722446|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
74084651|NCT00578968|147722447|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
74084652|NCT00578968|147722448|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANOVA|||||||0.005
74084653|NCT00578968|147722449|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||||||0.06
74084654|NCT00578968|147722450|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||||||0.003
74084655|NCT00578968|147722451|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANOVA|||||||0.60
74084656|NCT00578968|147722452|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||||||0.35
74084657|NCT00578968|147722453|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANOVA|||||||0.65
74084658|NCT00578968|147722454|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||||||0.43
74084659|NCT00578968|147722455|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||ANOVA|||Comparison was made between groups at pretreatment resting time period.||||0.73
74084660|NCT00578968|147722455|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Comparison was made between groups at pretreatment peak exercise time period.||||0.11
74084661|NCT00578968|147722456|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
74084662|NCT00578968|147722457|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||||||0.06
74084663|NCT00578968|147722458|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||ANOVA|||||||0.09
74084664|NCT00578968|147722459|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
74084665|NCT00578968|147722460|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
74084666|NCT00578968|147722461|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||ANOVA|||||||0.19
73899903|NCT02415842|147331253|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|-6.07|||||TWO_SIDED|95.0|-30.56|18.65|||Asymptotic standardized 95% CI|||||18.65|-30.56|
73899904|NCT02415842|147331254|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|27.08|||||TWO_SIDED|95.0|5.96|47.01|||Asymptotic standardized 95% CI|||||47.01|5.96|
73960399|NCT03622580|147456195|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-9.9|8.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||8.2|-9.9|
73960400|NCT03622580|147456198|OTHER||Difference in CMH Weighted Percentage|-3.2|||||TWO_SIDED|95.0|-10.2|3.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||3.8|-10.2|
73960401|NCT03622580|147456198|OTHER||Difference in CMH Weighted Percentage|2.4|||||TWO_SIDED|95.0|-4.3|9.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.2|-4.3|
73960402|NCT03622580|147456198|OTHER||Difference in CMH Weighted Percentage|-4.7|||||TWO_SIDED|95.0|-12.6|3.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||3.1|-12.6|
74084667|NCT00578968|147722462|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
73960403|NCT03622580|147456198|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-8.9|6.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||6.4|-8.9|
73960404|NCT03622580|147456201|OTHER||Difference in CMH Weighted Percentage|0.6|||||TWO_SIDED|95.0|-1.8|2.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.9|-1.8|
73960405|NCT03622580|147456201|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.2|2.3||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.3|-2.2|
73960406|NCT03622580|147456201|OTHER||Difference in CMH Weighted Percentage|0.8|||||TWO_SIDED|95.0|-2.0|3.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||3.6|-2.0|
73960407|NCT03622580|147456201|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.6|2.5||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.5|-2.6|
73960408|NCT03622580|147456210|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.1|2.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.1|
73960409|NCT03622580|147456210|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.1|2.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.1|
73960410|NCT03622580|147456210|OTHER||Difference in CMH Weighted Percentage|-0.6|||||TWO_SIDED|95.0|-1.9|0.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.6|-1.9|
74084668|NCT00578968|147722463|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
73960411|NCT03622580|147456210|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.5|2.5||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.5|-1.5|
73960412|NCT03622580|147456211|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-0.4|1.2||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.2|-0.4|
73960413|NCT03622580|147456211|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
73960414|NCT03622580|147456211|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
73960415|NCT03622580|147456211|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
73960416|NCT03622580|147456218|OTHER||Adjusted mean difference|-36.2|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|95.0|-47.8|-24.7||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-24.7|-47.8|
73960417|NCT03622580|147456218|OTHER||Adjusted mean difference|-26.2|STANDARD_ERROR_OF_MEAN|5.86|||TWO_SIDED|95.0|-37.7|-14.7||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-14.7|-37.7|
73960418|NCT03622580|147456218|OTHER||Adjusted mean difference|-31.1|STANDARD_ERROR_OF_MEAN|6.35|||TWO_SIDED|95.0|-43.6|-18.6||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-18.6|-43.6|
73960419|NCT03622580|147456218|OTHER||Adjusted mean difference|-23.9|STANDARD_ERROR_OF_MEAN|6.28|||TWO_SIDED|95.0|-36.2|-11.6||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-11.6|-36.2|
74084669|NCT00603564|147722464|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||endpoint was analyzed in terms of time by comparison of mean +- SD||||<0.001
74084670|NCT00603564|147722465|SUPERIORITY_OR_OTHER|||||||7e-06||95.0|||||Chi-squared|||||||0.000007
74084671|NCT01350934|147722476|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|1.95|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|0.8|3.1|||Longitudinal data analysis|||||3.1|0.8|<0.001
74084672|NCT01350934|147722477|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|2.92|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.8|4.1|||Longitudinal data analysis|||||4.1|1.8|<0.001
74084673|NCT01350934|147722478|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-42.37|||<|0.001|TWO_SIDED|95.0|-48.16|-36.67|||Constrained longitudinal data analysis|||||-36.67|-48.16|<0.001
73899905|NCT02415842|147331254|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|36.65|||||TWO_SIDED|95.0|11.41|57.53|||Asymptotic standardized 95% CI|||||57.53|11.41|
73899906|NCT02415842|147331254|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|6.39|||||TWO_SIDED|95.0|-11.91|24.71|||Asymptotic standardized 95% CI|||||24.71|-11.91|
73899907|NCT02415842|147331254|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 365.|Difference in percentage of subjects|6.9|||||TWO_SIDED|95.0|-6.19|22.15|||Asymptotic standardized 95% CI|||||22.15|-6.19|
73899908|NCT02415842|147331255|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|3.33|||||TWO_SIDED|95.0|-13.06|20.24|||Asymptotic standardized 95% CI|||||20.24|-13.06|
73899909|NCT02415842|147331255|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|16.67|||||TWO_SIDED|95.0|0.35|34.76|||Asymptotic standardized 95% CI|||||34.76|0.35|
73899910|NCT02415842|147331255|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|0.24|||||TWO_SIDED|95.0|-13.76|15.0|||Asymptotic standardized 95% CI|||||15.00|-13.76|
73899911|NCT03739242|147331273|SUPERIORITY||Least Square Mean difference|-39.16|||<|0.0001|TWO_SIDED|95.0|-48.57|-29.75|||ANCOVA|||||-29.75|-48.57|<0.0001
73899912|NCT03739242|147331274|SUPERIORITY||Least Square Mean difference|-41.24||||0.0001|TWO_SIDED|95.0|-51.73|-30.74|||ANCOVA|||||-30.74|-51.73|0.0001
73899913|NCT03739242|147331275|SUPERIORITY||Least Square Mean difference|0.09||||0.951|TWO_SIDED|95.0|-2.87|3.05|||ANCOVA|||||3.05|-2.87|0.9510
73899914|NCT03739242|147331276|SUPERIORITY||Least Square Mean difference|-41.7|||<|0.0001|TWO_SIDED|95.0|-51.58|-31.82|||ANCOVA|||||-31.82|-51.58|<0.0001
73899915|NCT03739242|147331277|SUPERIORITY||Least Square Mean difference|-7.0||||0.1924|TWO_SIDED|95.0|-17.59|3.59|||ANCOVA|||||3.59|-17.59|0.1924
73899916|NCT03739242|147331278|SUPERIORITY||Least Square Mean difference|-17.26|||<|0.0001|TWO_SIDED|95.0|-23.54|-10.98|||ANCOVA|||||-10.98|-23.54|<0.0001
73960420|NCT03622580|147456221|OTHER||Difference in CMH Weighted Percentage|16.0|||||TWO_SIDED|95.0|8.9|23.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||23.1|8.9|
74084674|NCT01350934|147722479|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-52.03|||<|0.001|TWO_SIDED|95.0|-59.04|-45.3|||Constrained longitudinal data analysis|||||-45.30|-59.04|<0.001
73899917|NCT03739242|147331279|SUPERIORITY||Least Square Mean difference|-0.91|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.62|||ANCOVA|||||-0.62|-1.19|<0.0001
73899918|NCT03739242|147331280|SUPERIORITY||Least Square Mean difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.05|-0.59|||ANCOVA|||||-0.59|-1.05|<0.0001
73899919|NCT03739242|147331281|SUPERIORITY||Least Square Mean difference|-3.47||||0.4535|TWO_SIDED|95.0|-12.64|5.7|||ANCOVA|||||5.7|-12.64|0.4535
73899920|NCT03739242|147331282|SUPERIORITY||Least Square Mean difference|0.74||||0.5594|TWO_SIDED|95.0|-1.76|3.24|||ANCOVA|||||3.24|-1.76|0.5594
73899921|NCT03739242|147331283|SUPERIORITY||Least Square Mean difference|-0.07||||0.9266|TWO_SIDED|95.0|-1.63|1.48|||ANCOVA|||||1.48|-1.63|0.9266
73899922|NCT03739242|147331284|SUPERIORITY||Least Square Mean difference|6.02||||0.2654|TWO_SIDED|95.0|-4.66|16.69|||ANCOVA|||||16.69|-4.66|0.2654
73899923|NCT03739242|147331285|SUPERIORITY||Least Square Mean difference|-5.95||||0.2595|TWO_SIDED|95.0|-16.37|4.47|||ANCOVA|||||4.47|-16.37|0.2595
73899924|NCT03739242|147331286|SUPERIORITY||Least Square Mean difference|0.003||||0.8476|TWO_SIDED|95.0|-0.039|0.032|||ANCOVA|||||0.032|-0.039|0.8476
73899925|NCT03739242|147331287|SUPERIORITY||Least Square Mean difference|-0.21||||0.1499|TWO_SIDED|95.0|-0.49|0.08|||ANCOVA|||||0.08|-0.49|0.1499
73899926|NCT03739242|147331288|SUPERIORITY||Least Square Mean difference|1.71||||0.7224|TWO_SIDED|95.0|-7.83|11.25|||ANCOVA|||||11.25|-7.83|0.7224
73899927|NCT01992159|147331289|SUPERIORITY||Treatment Difference|7.5|||<|0.0001|ONE_SIDED|95.0|6.5|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||6.5|< 0.0001
73899928|NCT01992159|147331289|SUPERIORITY||Treatment Difference|12.4|||<|0.0001|ONE_SIDED|95.0|11.1|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||11.1|< 0.0001
73930697|NCT03238911|147391293|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0023|TWO_SIDED|95.0|-0.6|-0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.13|-0.60|0.0023
73930698|NCT03238911|147391293|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.0008|TWO_SIDED|95.0|-0.8|-0.21|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.21|-0.80|0.0008
73899929|NCT01992159|147331289|SUPERIORITY||Treatment Difference|16.0|||<|0.0001|ONE_SIDED|95.0|14.6|||One-sided p-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||14.6|< 0.0001
73899930|NCT01992159|147331290|SUPERIORITY||Treatment Difference|5.3|||<|0.0001|ONE_SIDED|95.0|4.4||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||4.4|< 0.0001
73899931|NCT01992159|147331290|SUPERIORITY||Treatment Difference|9.0|||<|0.0001|ONE_SIDED|95.0|8.0||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||8.0|< 0.0001
73899932|NCT01992159|147331290|SUPERIORITY||Treatment Difference|11.9|||<|0.0001|ONE_SIDED|95.0|10.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||10.6|< 0.0001
73899933|NCT01992159|147331291|SUPERIORITY||Treatment Difference|0.6||||0.125|ONE_SIDED|95.0|-0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||-0.3|0.1250
73899934|NCT01992159|147331291|SUPERIORITY||Treatment Difference|1.7||||0.0002|ONE_SIDED|95.0|0.9||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.9|0.0002
73899935|NCT01992159|147331291|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.7|< 0.0001
73899936|NCT01992159|147331292|SUPERIORITY||Treatment Difference|1.5||||0.0012|ONE_SIDED|95.0|0.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.7|0.0012
73899937|NCT01992159|147331292|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.8||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.8|< 0.0001
73899938|NCT01992159|147331292|SUPERIORITY||Treatment Difference|4.1|||<|0.0001|ONE_SIDED|95.0|3.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||3.3|< 0.0001
73899939|NCT01992159|147331293|SUPERIORITY||Treatment Difference|0.3||||0.2846|ONE_SIDED|95.0|-0.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||-0.6|0.2846
73899940|NCT01992159|147331293|SUPERIORITY||Treatment Difference|1.3||||0.0151|ONE_SIDED|95.0|0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.3|0.0151
73899941|NCT01992159|147331293|SUPERIORITY||Treatment Difference|2.6||||0.0001|ONE_SIDED|95.0|1.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.5|0.0001
73960421|NCT03622580|147456221|OTHER||Difference in CMH Weighted Percentage|12.7|||||TWO_SIDED|95.0|5.4|20.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||20.0|5.4|
73960422|NCT03622580|147456221|OTHER||Difference in CMH Weighted Percentage|15.2|||||TWO_SIDED|95.0|7.3|23.2||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||23.2|7.3|
73899942|NCT01992159|147331294|SUPERIORITY||Treatment Difference|1.6||||0.0067|ONE_SIDED|95.0|0.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.5|0.0067
73899943|NCT01992159|147331294|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.6|< 0.0001
73899944|NCT01992159|147331294|SUPERIORITY||Treatment Difference|3.5|||<|0.0001|ONE_SIDED|95.0|2.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||2.3|< 0.0001
73899945|NCT01992159|147331299|SUPERIORITY||Treatment Difference|-15.3||||0.5084|TWO_SIDED|95.0|-60.8|30.2|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||30.2|-60.8|0.5084
73899946|NCT01992159|147331299|SUPERIORITY||Treatment Difference|84.1||||0.0002|TWO_SIDED|95.0|40.1|128.0|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||128.0|40.1|0.0002
73899947|NCT01992159|147331299|SUPERIORITY||Treatment Difference|153.8|||<|0.0001|TWO_SIDED|95.0|109.2|198.4|||ANCOVA|ANCOVA model with the AUC of P1NP at months 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||198.4|109.2|< 0.0001
73960423|NCT03622580|147456221|OTHER||Difference in CMH Weighted Percentage|12.5|||||TWO_SIDED|95.0|4.4|20.6||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||20.6|4.4|
73960424|NCT01290224|147456268|NON_INFERIORITY_OR_EQUIVALENCE|A one-sided McNemar's test of the primary endpoint with 10 patients will have 86% power at 5% Type I error rate to detect a 60% difference in the percentage of at least 50% reduction in the scrambler and sham procedure, based on the assumption that the proportion of discordant pairs is at 70%.||||||0.763||95.0|||||McNemar|||McNemar's test was used to test for a difference between Scrambler and Sham procedure in their success rate.||||0.7630
73960425|NCT03861767|147456284|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.67|1.97||||||Low dose groups collapsed and compared to placebo||1.97|0.67|
73960426|NCT03861767|147456284|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.42|1.25||||||Intermediate dose groups were collapsed and compared to placebo||1.25|0.42|
73960427|NCT03861767|147456284|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.61|1.84||||||High dose groups were collapsed and compared to placebo||1.84|0.61|
73960428|NCT03861767|147456285|SUPERIORITY||Odds Ratio (OR)|1.03||||0.92|TWO_SIDED|95.0|0.52|2.03|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.03|0.52|0.92
73960429|NCT03861767|147456286|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8|TWO_SIDED|95.0|0.52|2.0|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.00|0.52|0.80
73960430|NCT03861767|147456287|SUPERIORITY||Odds Ratio (OR)|1.23||||0.65|TWO_SIDED|95.0|0.49|3.11|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||3.11|0.49|0.65
73960431|NCT03861767|147456288|SUPERIORITY||Odds Ratio (OR)|1.62||||0.23|TWO_SIDED|95.0|0.73|3.62|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||3.62|0.73|0.23
73960432|NCT03861767|147456289|SUPERIORITY||Odds Ratio (OR)|1.42||||0.31|TWO_SIDED|95.0|0.71|2.86|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.86|0.71|0.31
73960433|NCT03861767|147456290|SUPERIORITY||Beta-coefficient|0.0011|STANDARD_ERROR_OF_MEAN|0.042||0.97|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.97
73960434|NCT03861767|147456291|SUPERIORITY||Beta-coefficient|-0.76|STANDARD_ERROR_OF_MEAN|0.74||0.3|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.30
73960435|NCT03861767|147456292|SUPERIORITY||Beta-coefficient|0.27|STANDARD_ERROR_OF_MEAN|0.59||0.65|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.65
73899948|NCT01205581|147331304|SUPERIORITY_OR_OTHER|||||||0.78|||||||Fisher Exact|||||||0.78
73899949|NCT01205581|147331307|SUPERIORITY_OR_OTHER|||||||0.48|||||||Fisher Exact|||||||0.48
73899950|NCT01205581|147331308|SUPERIORITY_OR_OTHER|||||||0.51|||||||Fisher Exact|||||||0.51
73899951|NCT01205581|147331309|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher Exact|||||||0.29
73960436|NCT03861767|147456294|SUPERIORITY||Odds Ratio (OR)|1.45||||0.27|TWO_SIDED|95.0|0.74|2.86|||Regression, Logistic|||||2.86|0.74|0.27
73960437|NCT03861767|147456295|SUPERIORITY||Odds Ratio (OR)|2.98||||0.01|TWO_SIDED|95.0|1.19|7.44|||Regression, Logistic|||All intervention groups were collapsed and compared to placebo||7.44|1.19|0.01
73960438|NCT03861767|147456296|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.01|TWO_SIDED|95.0|1.34|5.3|||Regression, Logistic|||All intervention groups were collapsed and compared to placebo||5.30|1.34|<0.01
73960439|NCT03861767|147456297|SUPERIORITY||Odds Ratio (OR)|0.9||||0.72|TWO_SIDED|95.0|0.52|1.56|||Regression, Logistic|||All intervention groups were collapsed into one group and compared with placebo. Patients were compared whether they were discharged home or other.||1.56|0.52|0.72
74084675|NCT01350934|147722480|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-51.07|||<|0.001|TWO_SIDED|95.0|-57.29|-44.99|||Constrained longitudinal data analysis|||||-44.99|-57.29|<0.001
74084676|NCT01350934|147722481|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-51.96|||<|0.001|TWO_SIDED|95.0|-58.77|-45.39|||Constrained longitudinal data analysis|||||-45.39|-58.77|<0.001
73899952|NCT01205581|147331310|SUPERIORITY_OR_OTHER|||||||0.43|||||||Fisher Exact|||||||0.43
74084677|NCT01350934|147722482|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0279|||<|0.001|TWO_SIDED|95.0|0.0074|0.1048|||Cochran-Mantel-Haenszel|||Odds Ratio comparison of percentage of participants with \<20 ng/mL of serum 25-hydroxyvitamin (OH) D between Fosamax Plus group and Calcitriol group.||0.1048|0.0074|<0.001
74084678|NCT01196117|147722484|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||||||0.0009
74084679|NCT01196117|147722485|SUPERIORITY|||||||0.8938|||||||Wilcoxon (Mann-Whitney)|||||||0.8938
74084680|NCT01196117|147722486|SUPERIORITY||||||<|0.014|||||||Wilcoxon (Mann-Whitney)|||||||<0.014
74084681|NCT01196117|147722487|SUPERIORITY||||||<|0.02|||||||Wilcoxon (Mann-Whitney)|||||||<0.0200
73847693|NCT00523978|147241152|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin was selected based on literature review.|||||<|0.001|||||||t-test, 1 sided|||The null hypothesis is the proportion of subjects free from MAFE in the experimental group is inferior to that in the control group using 10% non-inferiority margin.A sample size of 160 evaluable cryoablation and 80 control subjects (one-sided α = 0.05, 2:1 randomization) was required to provide 80% power assuming the rate of free from MAFE at 12 months 80.5 and 77% in experimental and control groups respectively .||||<0.001
73847694|NCT00523978|147241153|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||The test hypothesis is UCBExperimental\_CPE ≥ 14.8% vs UCBExperimental\_CPE \< 14.8%.The performance goal 14.8% was chosen based on a review of SSEDs for similar types of ablation trials.The expected rate for CPEs in a well-monitored trial of left atrial RF ablation for AF was estimated to be 10% (corresponding to a CPE-free rate of 90%).In a trial with 160 subject, the resulting one-sided 95% upper confidence bound would be 14.8%.||||<0.001
73899953|NCT01205581|147331311|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
73899954|NCT05033002|147331365|SUPERIORITY||Slope|-0.41|||<|0.0001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||<.0001
73847695|NCT02553629|147241165|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
73847696|NCT02553629|147241166|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73847697|NCT02553629|147241167|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
73847698|NCT02553629|147241168|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73847699|NCT02553629|147241169|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73847700|NCT01812057|147241170|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.740
73847701|NCT01812057|147241171|SUPERIORITY|Pain Score at rest at 2 hours||||||0.171|||||||t-test, 2 sided|||||||0.171
73847702|NCT01812057|147241171|SUPERIORITY|Pain Score with movement at 2 hours||||||0.204|||||||t-test, 2 sided|||||||0.204
73847703|NCT01812057|147241172|SUPERIORITY|||||||0.1965|||||||Log Rank|||||||0.1965
73847704|NCT01812057|147241173|SUPERIORITY|||||||0.709|||||||Wilcoxon (Mann-Whitney)|||||||0.709
73847705|NCT01812057|147241174|SUPERIORITY|Pain Score at rest at 24 hours||||||0.267|||||||Wilcoxon (Mann-Whitney)|||||||0.267
73899955|NCT05033002|147331365|SUPERIORITY||Slope|0.002|||<|0.0001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||<.0001
73899956|NCT05033002|147331366|SUPERIORITY||Slope|0.06||||0.002|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||.002
73899957|NCT05033002|147331366|SUPERIORITY||Slope|-0.0003||||0.01|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.010
73899958|NCT05033002|147331367|SUPERIORITY||Slope|0.05||||0.001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||.001
73899959|NCT05033002|147331367|SUPERIORITY||Slope|-0.0002||||0.032|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.032
73899960|NCT05033002|147331368|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.506|TWO_SIDED||||||t-test, 2 sided|||||||0.506
73899961|NCT05033002|147331369|SUPERIORITY|||||||0.441||||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis|The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.||||||.441
74084682|NCT01196117|147722488|SUPERIORITY|||||||0.1321|||||||Wilcoxon (Mann-Whitney)|||||||0.1321
74084683|NCT01196117|147722489|SUPERIORITY||||||<|0.249|||||||Wilcoxon (Mann-Whitney)|||||||<0.2490
74084684|NCT01196117|147722490|SUPERIORITY|||||||0.5139|||||||Wilcoxon (Mann-Whitney)|||||||0.5139
74084685|NCT01196117|147722491|SUPERIORITY|||||||0.0597|||||||Wilcoxon (Mann-Whitney)|||||||0.0597
74084686|NCT01196117|147722492|SUPERIORITY|||||||0.2134|||||||Wilcoxon (Mann-Whitney)|||||||0.2134
74084687|NCT00676650|147722498|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.914||||0.1678|TWO_SIDED|95.0|0.762|1.097||1-sided p-value from the stratified log-rank test|Log Rank||Based on the Cox Proportional hazards model stratified by Eastern Cooperative Oncology Group (ECOG) and Disease Progression Base.|||1.097|0.762|0.1678
74084688|NCT00676650|147722499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725|||<|0.001|TWO_SIDED|95.0|0.591|0.89||1-sided p-value from the stratified log-rank test.|Log Rank||Based on Cox Proportional Hazards Model stratified by ECOG and Disease Progression Base.|||0.890|0.591|<0.001
74084689|NCT00676650|147722500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.561||||0.04|TWO_SIDED|95.0|1.0|19.0||p-value from 2-sided Fisher's Exact test.|Fisher Exact|||||19.0|1.0|0.040
74084690|NCT00683592|147722506|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-2.5||||0.009|TWO_SIDED|95.0|-4.4|-0.6|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline MADRS total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.6|-4.4|0.009
74023270|NCT05817045|147599182|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.35||||0.007|TWO_SIDED|95.0|1.086|1.69|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) - Secondary analysis - (FAS excluding subjects that were qPCR negative at baseline)||1.690|1.086|0.007
74084691|NCT00683592|147722507|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-1.6||||0.026|TWO_SIDED|95.0|-3.1|-0.2|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-D 17 total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.2|-3.1|0.026
74084692|NCT00683592|147722508|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Improve|-0.3||||0.004|TWO_SIDED|95.0|-0.5|-0.1|||ANOVA|||The model was an analysis of variance (ANOVA), with terms for treatment group and center. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.1|-0.5|0.004
74084693|NCT00683592|147722509|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-1.2||||0.037|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-A total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.1|-2.4|0.037
74084694|NCT00683592|147722510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.134||||0.002|TWO_SIDED|95.0|0.047|0.221|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS response rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.||0.221|0.047|0.002
74084695|NCT00683592|147722511|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.069||||0.066|TWO_SIDED|95.0|-0.008|0.147|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS remission rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.||0.147|-0.008|0.066
74084696|NCT00685035|147722537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_DEVIATION|0.23||0.02|TWO_SIDED|95.0|||||ANCOVA|||||||.02
74084697|NCT04241133|147722554|OTHER|The experimental and control groups were not compared due to the inability to collect post data with the control group because of stay at home orders during the COVID-19 pandemic.|||||<|0.05||||||The reported P-value was calculated.|t-test, 2 sided|The a priori threshold for statistical significance was P\<0.05.||The experimental group was tested for significant difference in Healthy Eating Index 2015 (HEI-2015) scores at baseline and 12 weeks. SAS macros provided by the National Cancer Institute were used to compute HEI-2015 scores for each dietary recall at pre- (baseline) and post-intervention (12 weeks) using the Simple HEI Scoring Algorithm.||||<0.05
74084698|NCT01503333|147722555|EQUIVALENCE|Linear mixed-effect models were applied to examine the intervention effect on MVPA at post-intervention. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at post-intervention.|parameter estimate|-0.08||||0.207|TWO_SIDED|95.0|-0.21|0.05|||Mixed Models Analysis|||Hypotheses: Post-intervention, weighted mean minutes of MVPA/week will be greater by 16 minutes among girls in intervention than control schools. Mean minutes per week is determined by multiplying mean minutes/hour by 90 hours that girls are awake in a week (10 hours awake on each weekend day; 14 hours awake on each weekday).||0.05|-0.21|.207
74084699|NCT01503333|147722556|EQUIVALENCE|Linear mixed models were used to analyze intervention effect on CV fitness according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline CV fitness, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.018|TWO_SIDED|95.0|0.03|0.36|||Mixed Models Analysis|||Immediately post-intervention, cardiovascular (CV) fitness will be higher among girls in the intervention than control schools.||0.36|0.03|.018
74084700|NCT01503333|147722557|OTHER|Linear mixed models were used to analyze intervention effect on BMI-z according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models for BMI-z included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline BMI-z, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.191|TWO_SIDED|95.0|-0.05|0.01|||Mixed Models Analysis|||Immediately post-intervention, BMI z-score will be significantly lower among girls in the intervention than control schools.||0.01|-0.05|.191
74084701|NCT01503333|147722558|EQUIVALENCE|Linear mixed models were used to analyze intervention effect on % body fat according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline % body fat, age, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and year cohort.|parameter estimate|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.007|TWO_SIDED|95.0|-0.64|-0.1|||Mixed Models Analysis|||Immediately post-intervention, percent body fat will be significantly lower among girls in the intervention than control schools.||-0.10|-0.64|.007
74084702|NCT01503333|147722559|EQUIVALENCE|Linear mixed-effect models were applied to examine the intervention effect on MVPA at 9-month follow up. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at follow up.|parameter estimate|-0.09||||0.118|TWO_SIDED|95.0|-0.21|0.02|||Mixed Models Analysis|||||0.02|-0.21|.118
74084703|NCT01503333|147722560|OTHER||parameter estimate|-0.97|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-square test p\>.05.26.||||
74084704|NCT01503333|147722561|OTHER||parameter estimate|2.9|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
73847706|NCT01812057|147241174|SUPERIORITY|Pain Score with movement at 24 hours||||||0.518|||||||t-test, 2 sided|||||||0.518
73847707|NCT01812057|147241175|SUPERIORITY|Pain Score at rest at 48 hours||||||0.491|||||||Wilcoxon (Mann-Whitney)|||||||0.491
73847708|NCT01812057|147241175|SUPERIORITY|Pain Scores with movement at 48 hours||||||0.525|||||||Wilcoxon (Mann-Whitney)|||||||0.525
73847709|NCT01812057|147241176|SUPERIORITY|||||||0.355|||||||Wilcoxon (Mann-Whitney)|Total opioid consumption at 24 hours|||We also performed a multivariable regression analysis to determine factors associated with 24h opioid consumption accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factor with the largest p-value over 0.05.In the final model MTS was not associated with 24h opioid consumption parameter estimate (standard error) = 9.15 (5.27), p=0.09.|||0.355
73847710|NCT01812057|147241177|SUPERIORITY|||||||0.42|||||||Fisher Exact|Chronic pain at 8 weeks||||||0.420
73847711|NCT01812057|147241178|SUPERIORITY|||||||0.322|||||||Fisher Exact|||||||0.322
73847712|NCT01812057|147241179|SUPERIORITY|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||24 hour pain scores at rest between MTS groups|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores at rest.|||0.805
73847713|NCT01812057|147241179|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Pain scores on movement at 24h|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminated the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores on movement.|||1.000
73847714|NCT01812057|147241180|SUPERIORITY|Intraoperative nausea and vomiting||||||0.245|||||||Fisher Exact|||||||0.245
73847715|NCT01812057|147241180|SUPERIORITY|||||||0.676|||||||Chi-squared|Need for intraoperative antiemetics||||||0.676
73847716|NCT01812057|147241180|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73847717|NCT01812057|147241182|SUPERIORITY|||||||0.924|||||||Chi-squared|Incidence of postoperative pruritus||||||0.924
73847718|NCT01812057|147241183|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.700
73847719|NCT01812057|147241184|SUPERIORITY|||||||0.302|||||||Chi-squared|Incidence of PONV at 24 h||||||0.302
73847720|NCT01812057|147241184|SUPERIORITY|||||||0.028|||||||Chi-squared|Postoperative need for rescue antiemetic||||||0.028
73847721|NCT01812057|147241184|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73847722|NCT01812057|147241184|SUPERIORITY|||||||0.188|||||||Chi-squared|||||||0.188
73847723|NCT00696878|147241198|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||0.4|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 1|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||0.4||
73847724|NCT00696878|147241198|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||0.8|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 2|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||0.8||
73899962|NCT05033002|147331369|SUPERIORITY||Slope|0.0002||||0.734|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.734
73899963|NCT04972630|147331370|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0||||||||Baseline control vs. intervention||||
73899964|NCT04972630|147331370|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0||||||||Week 4 control vs. intervention||||
73899965|NCT04972630|147331370|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
73899966|NCT04972630|147331370|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
73899967|NCT04972630|147331371|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||||||
73899968|NCT04972630|147331372|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0||||||||||||
73847725|NCT00696878|147241198|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||1.5|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 3|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||1.5||
73847726|NCT03937479|147241277|SUPERIORITY||LS mean difference|0.1242|STANDARD_ERROR_OF_MEAN|0.03691||0.0008|TWO_SIDED|95.0|0.0517|0.1968||The mixed model for repeated measures (MMRM) model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1968|0.0517|0.0008
73847727|NCT03937479|147241277|SUPERIORITY||LS mean difference|0.1072|STANDARD_ERROR_OF_MEAN|0.03703||0.004|TWO_SIDED|95.0|0.0344|0.18||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1800|0.0344|0.0040
73847728|NCT03937479|147241277|SUPERIORITY||LS mean difference|0.0912|STANDARD_ERROR_OF_MEAN|0.03723||0.0148|TWO_SIDED|95.0|0.018|0.1643||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1643|0.0180|0.0148
73847729|NCT03937479|147241277|SUPERIORITY||LS mean difference|0.0775|STANDARD_ERROR_OF_MEAN|0.03697||0.0368|TWO_SIDED|95.0|0.0048|0.1501||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1501|0.0048|0.0368
73847730|NCT00940602|147241296|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.636||||0.015|TWO_SIDED|95.0|0.42|0.96||Exploratory p-value is one tailed and is based on the stratified log-rank test.|Regression, Cox||95% CI was based on a Wald test from Cox model|||0.96|0.42|0.015
73847731|NCT00940602|147241297|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|12.0|||||TWO_SIDED|95.0|-1.8|25.7||||||||25.7|-1.8|
73847732|NCT00940602|147241298|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.832||||0.2|TWO_SIDED|95.0|0.54|1.28|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.28|0.54|0.200
73847733|NCT00940602|147241299|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.4|||||TWO_SIDED|95.0|-5.3|8.1||||||||8.1|-5.3|
73847734|NCT00940602|147241300|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|-0.3|||||TWO_SIDED|95.0|-12.0|11.4||||||||11.4|-12.0|
73847735|NCT00940602|147241301|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.725||||0.184|TWO_SIDED|95.0|0.36|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.36|0.184
73960440|NCT00346333|147456302|SUPERIORITY_OR_OTHER|||||||0.66||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||"Primary Analysis:Proc mixed of the Statistical Analysis System (SAS) was used to compare annual rates of change by treatment group over 4 years.~Power Calculation:240 patients were estimated to be needed to provide sufficient power (i.e. alpha=0.05;beta=0.10)to observe a statistically significant difference between mean change in the 2 groups on the HFA 30-2 total point score over a 4-year interval."||||0.66
73847736|NCT00940602|147241302|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.195|||<|0.001|TWO_SIDED|95.0|0.11|0.36|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||0.36|0.11|<.001
73847737|NCT00940602|147241303|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.871||||0.303|TWO_SIDED|95.0|0.52|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.52|0.303
73847738|NCT00940602|147241304|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|1.072||||0.389|TWO_SIDED|95.0|0.66|1.75|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.75|0.66|0.389
73847739|NCT00940602|147241306|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.5|||||TWO_SIDED|95.0|-5.2|8.1||||||||8.1|-5.2|
73847740|NCT00940602|147241307|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|0.7|||||TWO_SIDED|95.0|-1.6|3.0||||||||3.0|-1.6|
73847741|NCT00940602|147241308|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.4|||||TWO_SIDED|95.0|-11.9|14.6||||||||14.6|-11.9|
73847742|NCT00940602|147241309|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|-9.6|||||TWO_SIDED|95.0|-20.8|1.6||||||||1.6|-20.8|
73847743|NCT00940602|147241310|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.797||||0.232|TWO_SIDED|95.0|0.43|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.43|0.232
73847744|NCT01120405|147241317|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of xenon over sevoflurane is accepted if the upper bound of the two-sided 95% CI around the estimated difference is below the prespecified non-inferiority margin of 10%.|Difference of proportion|0.19||||0.0052|TWO_SIDED|95.0|-6.7|7.07|||Difference of proportion|||"The percentage of patients with MN during the 3 postoperative days in the sevoflurane group and in the xenon group was expected to be 20%. The margin of non-inferiority was 10%. Thus the sample size to prove non-inferiority was 252 patients per group with α = 0.025, a power of 0.80 and the following hypotheses: H0: Px-Pc ≥ 10%; H1: Px-Pc \< 10%.~As it was expected that approximately 15% of patients would be non-evaluable, a total of 600 patients were included."||7.07|-6.70|0.0052
73847745|NCT01120405|147241318|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.7715|TWO_SIDED|95.0|-3.9|5.25|||Difference of proportion|||||5.25|-3.90|0.7715
73847746|NCT01120405|147241319|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.4763|TWO_SIDED|95.0|-1.19|2.54|||Difference of proportion|||||2.54|-1.19|0.4763
73847747|NCT01120405|147241320|SUPERIORITY_OR_OTHER||Difference of proportion|-0.34||||0.6533|TWO_SIDED|95.0|-1.82|1.14|||Difference of proportion|||||1.14|-1.82|0.6533
73847748|NCT01120405|147241321|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.1559|TWO_SIDED|95.0|-0.26|1.61|||Difference of proportion|||||1.61|-0.26|0.1559
73899969|NCT04972630|147331373|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-1.7|||||TWO_SIDED|95.0||||||||||||
73899970|NCT04972630|147331374|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0||||||||||||
73899971|NCT04972630|147331375|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0||||||||||||
73899972|NCT04972630|147331376|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|3.2|||||TWO_SIDED|95.0||||||||||||
73899973|NCT04972630|147331377|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-5.0|||||TWO_SIDED|95.0||||||||||||
73960441|NCT00346333|147456302|SUPERIORITY_OR_OTHER|||||||0.52||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.52
73960442|NCT00346333|147456303|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary Analysis: Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye. Each patient contributed 2, 1, or 0 eyes with non-missing data.||||0.05
74084705|NCT01503333|147722562|OTHER||parameter estimate|0.47|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
73899974|NCT04972630|147331378|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-4.5|||||TWO_SIDED|95.0||||||||||||
73899975|NCT04972630|147331379|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-6.4|||||TWO_SIDED|95.0||||||||||||
73899976|NCT04972630|147331380|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-3.8|||||TWO_SIDED|95.0||||||||||||
73899977|NCT04972630|147331381|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-16.7|||||TWO_SIDED|95.0||||||||||||
73899978|NCT04972630|147331382|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||||||
73899979|NCT04972630|147331383|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0||||||||Baseline, control vs. intervention||||
73899980|NCT04972630|147331383|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0||||||||Week 4, control vs. intervention||||
73899981|NCT04972630|147331383|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
73899982|NCT04972630|147331383|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
73899983|NCT04972630|147331384|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0||||||||Baseline, control vs. intervention||||
73899984|NCT04972630|147331384|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||Week 4, control vs. intervention||||
73899985|NCT04972630|147331384|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
73899986|NCT04972630|147331384|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
73899987|NCT00075270|147331387|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.87||||0.142|TWO_SIDED|95.0|0.72|1.05||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio is based on the log-rank test.|||1.05|0.72|0.142
73899988|NCT00075270|147331388|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.82||||0.094|TWO_SIDED|95.0|0.65|1.04||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio was based on the log-rank test.|||1.04|0.65|0.094
73899989|NCT04896229|147331420|SUPERIORITY||Slope|1.2|STANDARD_ERROR_OF_MEAN|0.52||0.022|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.022
73899990|NCT04896229|147331421|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.35||0.8|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.800
73960443|NCT00346333|147456303|SUPERIORITY_OR_OTHER|||||||0.03||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.03
73960444|NCT00346333|147456304|SUPERIORITY_OR_OTHER|||||||0.24||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary analysis:Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye.Each patient contributed 2,1,or 0 eyes with non-missing data.||||0.24
74023271|NCT05817045|147599182|SUPERIORITY|SARS-CoV-2 rapid antigen test type: Flowflex|Cox Proportional Hazard|1.46|||||TWO_SIDED|95.0|1.064|1.997|||||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|Cox proportional hazards model for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (FAS)||1.997|1.064|
73847749|NCT01120405|147241323|SUPERIORITY_OR_OTHER||Difference of proportion|1.69||||0.6056|TWO_SIDED|95.0|-4.74|8.13|||Difference of proportion|||||8.13|-4.74|0.6056
73847750|NCT00508482|147241329|SUPERIORITY_OR_OTHER|||||||0.238|||||||Kruskal-Wallis|||Comparison among three groups over 4 weeks of treatment||||0.238
73847751|NCT00508482|147241329|SUPERIORITY_OR_OTHER|||||||0.004|||||||Kruskal-Wallis|||Comparison among three groups at the 4th week of follow-up||||0.004
73847752|NCT00508482|147241329|SUPERIORITY_OR_OTHER|||||||0.277|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.277
73847753|NCT00508482|147241329|SUPERIORITY_OR_OTHER|||||||0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.001
73847754|NCT00508482|147241329|SUPERIORITY_OR_OTHER|||||||0.055|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.055
73847755|NCT00508482|147241329|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||Comparison among three groups at the 12th week of follow-up||||0.001
73847756|NCT00508482|147241329|SUPERIORITY_OR_OTHER|||||||0.33|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||0.330
73847757|NCT00508482|147241329|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||<0.001
73847758|NCT00508482|147241329|SUPERIORITY_OR_OTHER|||||||0.018|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||0.018
73847759|NCT00508482|147241330|SUPERIORITY_OR_OTHER|||||||0.573|||||||ANOVA|||||||0.573
73847760|NCT00508482|147241331|SUPERIORITY_OR_OTHER|||||||0.271|||||||Kruskal-Wallis|||||||0.271
73847761|NCT00508482|147241332|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73847762|NCT00508482|147241332|SUPERIORITY_OR_OTHER|||||||0.58|||||||Least-Significant Difference|||||||0.580
73847763|NCT00508482|147241332|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
73847764|NCT00508482|147241332|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
73847765|NCT00508482|147241333|SUPERIORITY_OR_OTHER|||||||0.167|||||||ANOVA|||||||0.167
73847766|NCT00508482|147241334|SUPERIORITY_OR_OTHER|||||||0.066|||||||Kruskal-Wallis|||||||0.066
73847767|NCT00508482|147241335|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73847768|NCT00508482|147241335|SUPERIORITY_OR_OTHER|||||||0.024|||||||Least-Significant Difference|||||||0.024
73847769|NCT00508482|147241335|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
73847770|NCT00508482|147241335|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
73847771|NCT00508482|147241336|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73847772|NCT00508482|147241336|SUPERIORITY_OR_OTHER|||||||0.627||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.627
73847773|NCT00508482|147241336|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
73847774|NCT00508482|147241336|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
73847775|NCT00508482|147241337|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73847776|NCT00508482|147241337|SUPERIORITY_OR_OTHER|||||||0.587||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.587
73847777|NCT00508482|147241337|SUPERIORITY_OR_OTHER|||||||0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.001
73847778|NCT00508482|147241337|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
73847779|NCT00508482|147241338|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||||||0.006
73847780|NCT00508482|147241338|SUPERIORITY_OR_OTHER|||||||0.507||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.507
73847781|NCT00508482|147241338|SUPERIORITY_OR_OTHER|||||||0.005||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.005
73847782|NCT00508482|147241338|SUPERIORITY_OR_OTHER|||||||0.008||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.008
73847783|NCT02289469|147241339|SUPERIORITY||Mean Difference (Final Values)|23.8|||<|0.0001|TWO_SIDED|95.0|16.0|31.6|||Chi-squared|||A chi-square test was used to test for differences in proportions between intervention and control groups.||31.6|16.0|<0.0001
73847784|NCT02289469|147241340|OTHER||||||<|0.01|||||||Other|||Descriptive statistics (counts, frequencies) were used to summarize responses.||||<0.01
73847785|NCT01044030|147241374|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Chi-squared|||||||0.6
73847786|NCT02099084|147241438|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.74
73847787|NCT02099084|147241439|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 2-hours. Level of significance = .05||||0.20
73847788|NCT02099084|147241439|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 8-hours. Level of significance = .05||||0.17
73847789|NCT02099084|147241440|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.075
73847790|NCT02099084|147241443|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.42
73847791|NCT02099084|147241444|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.34
73847792|NCT01205503|147241445|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||This is for the interaction between baseline tnf-alpha levels and treatment received (mesna vs saline).|Mixed Models Analysis|Model was adjusted for baseline biochemical measures, time of measurement, treatment (mesna or saline), chemo type, and first-order interactions.||||||0.014
73847793|NCT00776789|147241451|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4
73847794|NCT00776789|147241452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0||95.0|1.4|4.3|||Wilcoxon (Mann-Whitney)|||Exclusive breast feeding at 48 hours was 95% (19 out of 20 partcipants were exclusively breast feeding)in the skin-to-skin contact group vs. 38.1% in the control group||4.3|1.4|0.00
73847795|NCT00776789|147241453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.001||95.0|1.6|6.3|||Wilcoxon (Mann-Whitney)|||||6.3|1.6|0.001
73847796|NCT01953211|147241461|SUPERIORITY_OR_OTHER||Slope|0.02|STANDARD_DEVIATION|0.57||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
73847797|NCT01953211|147241461|SUPERIORITY_OR_OTHER||Slope|0.63|STANDARD_DEVIATION|0.9|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
73847798|NCT01953211|147241461|SUPERIORITY_OR_OTHER||Slope|0.83|STANDARD_DEVIATION|0.78|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
73960445|NCT00346333|147456304|SUPERIORITY_OR_OTHER|||||||0.2||||||Apriori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.20
73847799|NCT00956384|147241477|SUPERIORITY|A minimally clinically important difference of 4 as statistically significant at the 0.05 level (two-sided), with a power equal to 0.85.|Mean Difference (Final Values)|-2.69||||0.05|TWO_SIDED|95.0|-10.57|5.19||Threshold for statistical significance was p= 0.05|t-test, 2 sided|||For the comparison of mean BREAST-Q subdomain score at each timepoint, Mann-Whitney U test was used for skewed data, while independent t-test was used for not skewed data. We investigated the possibly variable effects of the treatment group differences across multiple time-points, namely 2 weeks after mastectomy, at 6 months and at 12 months following the reconstruction procedure. A linear regression model was used to account for the correlation between the three time-points within each patient||5.19|-10.57|0.05
73847800|NCT00956384|147241478|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Regression, Logistic|||We assessed the effect of the surgical method on the occurrences of any complications versus none via logistic regression, and results were expressed as odds ratios with 95% CIs.||||<0.05
73960446|NCT00346333|147456305|SUPERIORITY_OR_OTHER|||||||0.59||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over four years between the treatment groups.||||0.59
73960447|NCT00346333|147456306|SUPERIORITY_OR_OTHER|||||||0.8||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over 4 years between the 2 groups.||||0.80
73847801|NCT00656370|147241483|SUPERIORITY|||||||0.93|||||||Wilcoxon signed rank test|||||||0.93
73847802|NCT00656370|147241484|SUPERIORITY|||||||0.67|||||||Wilcoxon signed rank test|||||||0.67
73847803|NCT01342094|147241487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.2|-0.9|||ANCOVA|||||-0.9|-2.2|< 0.001
73847804|NCT03391882|147241522|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|1.722||0.8944|TWO_SIDED|95.0|-3.16|3.62|||Mixed Models Analysis|||||3.62|-3.16|0.8944
73847805|NCT03391882|147241523|SUPERIORITY||Odds Ratio (OR)|1.129||||0.7777|TWO_SIDED|95.0|0.484|2.637|||generalized linear random effects model|||||2.637|0.484|0.7777
73847806|NCT03391882|147241524|SUPERIORITY|||||||0.0002|TWO_SIDED|||||The p-value is from a 1-sample, 2-sided test of the null hypothesis that the true proportion preferring APL is 50% to evaluate if a significantly higher proportion of the subjects prefer APL-130277 or not.|binomial distribution with normal approx|||||||0.0002
73847807|NCT03391882|147241525|SUPERIORITY||Odds Ratio (OR)|1.835||||0.1769|TWO_SIDED|95.0|0.759|4.438|||generalized linear random effects model|||||4.438|0.759|0.1769
73847808|NCT03391882|147241526|SUPERIORITY||Odds Ratio (OR)|1.47||||0.3922|TWO_SIDED|95.0|0.61|3.53|||generalized linear random effects model|||||3.53|0.61|0.3922
73847809|NCT02878382|147241541|SUPERIORITY||||||<|0.001||||||significance level of 5%|Chi-squared|also, Fisher's exact test and Mann-Whtiney were used for comparing the other variables in the study||||||<0.001
73847810|NCT02878382|147241543|SUPERIORITY||||||=|0.001||||||significance level of 5%|Fisher Exact|||||||=0.001
73847811|NCT02878382|147241544|SUPERIORITY||||||=|0.048|||||||Wilcoxon (Mann-Whitney)|||Student's t-test or the Mann-Whitney test was used according to the assumption of normality of data for PpIX fluorescence intensity||||=0.048
73847812|NCT01482715|147241552|OTHER||RP2D|600.0|||||TWO_SIDED||||||||||A MTD was not established based on observation of DLTs in Cycle 1 of treatment. The 600 mg BID dose was considered to be the maximum dose with an acceptable toxicity profile that could be continuously administered to patients and was selected as the recommended Phase 2 dose (RP2D).|||
73960448|NCT00723450|147456349|SUPERIORITY_OR_OTHER|||||||0.0717||95.0|||||Log Rank|A stratified log rank test was performed where the stratification factor was the index mood state at Screen visit.||||||0.0717
73847813|NCT01634152|147241563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.032||0.2724|TWO_SIDED|95.0|-0.028|0.099|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.099|-0.028|0.2724
73847814|NCT01634152|147241563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.075|0.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.203|0.075|<0.0001
73847815|NCT01634152|147241564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.018|STANDARD_ERROR_OF_MEAN|0.034||0.5898|TWO_SIDED|95.0|-0.048|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.||0.085|-0.048|0.5898
73847816|NCT01634152|147241564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.087|STANDARD_ERROR_OF_MEAN|0.034||0.0117|TWO_SIDED|95.0|0.019|0.154|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.||0.154|0.019|0.0117
73847817|NCT01634152|147241565|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.036||0.2277|TWO_SIDED|95.0|-0.113|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.027|-0.113|0.2277
73847818|NCT01634152|147241565|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.036||0.3998|TWO_SIDED|95.0|-0.04|0.101|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.101|-0.040|0.3998
73847819|NCT01634152|147241566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.037||0.203|TWO_SIDED|95.0|-0.121|0.026|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.026|-0.121|0.2030
73847820|NCT01634152|147241566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.009|STANDARD_ERROR_OF_MEAN|0.038||0.8194|TWO_SIDED|95.0|-0.066|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.083|-0.066|0.8194
73847821|NCT01634152|147241567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.031|STANDARD_ERROR_OF_MEAN|0.029||0.2907|TWO_SIDED|95.0|-0.026|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.088|-0.026|0.2907
73847822|NCT01634152|147241567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.068|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.184|0.068|<0.0001
73899991|NCT04896229|147331422|SUPERIORITY||Slope|0.58|STANDARD_ERROR_OF_MEAN|0.49||0.235|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.235
73960449|NCT05565391|147456410|OTHER||Risk Ratio (RR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.54|2.47|||Log-binomial regression model||Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.|||2.47|1.54|<.0001
73960450|NCT05565391|147456410|OTHER||Risk Ratio (RR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.52|2.67|||Log-binomial regression model||Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.|||2.67|1.52|<.0001
73847823|NCT01634152|147241568|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.041|STANDARD_ERROR_OF_MEAN|0.032||0.2008|TWO_SIDED|95.0|-0.103|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.022|-0.103|0.2008
73847824|NCT01634152|147241568|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.032||0.2545|TWO_SIDED|95.0|-0.026|0.1|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.100|-0.026|0.2545
73847825|NCT01634152|147241571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.078||0.798|TWO_SIDED|95.0|-0.133|0.173|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.173|-0.133|0.7980
73847826|NCT01634152|147241571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.079|STANDARD_ERROR_OF_MEAN|0.079||0.3166|TWO_SIDED|95.0|-0.233|0.076|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.076|-0.233|0.3166
73899992|NCT04896229|147331423|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.3||0.325|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.325
73899993|NCT04896229|147331424|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.502|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.502
73960451|NCT05565391|147456411|OTHER||Risk Ratio (RR)|2.22|||<|0.0001|TWO_SIDED|95.0|1.69|2.9|||Log-binomial regression model||Risk ratio was estimated using a log-binomial regression model and confidence interval was estimated using robust error variance.|||2.90|1.69|<.0001
73960452|NCT05565391|147456412|OTHER||Risk Ratio (RR)|1.79||||0.0447|TWO_SIDED|95.0|1.01|3.15|||Log-binomial regression model||Risk ratio was estimated using a log-binomial regression model and confidence interval was estimated using robust error variance.|||3.15|1.01|0.0447
73847827|NCT01634152|147241573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.124||0.8916|TWO_SIDED|95.0|-0.227|0.261|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.261|-0.227|0.8916
73847828|NCT01634152|147241573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089|STANDARD_ERROR_OF_MEAN|0.126||0.4789|TWO_SIDED|95.0|-0.336|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.158|-0.336|0.4789
73847829|NCT01634152|147241574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.074||0.8361|TWO_SIDED|95.0|-0.16|0.129|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.129|-0.160|0.8361
73847830|NCT01634152|147241574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.087|STANDARD_ERROR_OF_MEAN|0.075||0.2461|TWO_SIDED|95.0|-0.233|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.060|-0.233|0.2461
73847831|NCT01634152|147241575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.067||0.6029|TWO_SIDED|95.0|-0.096|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.165|-0.096|0.6029
73847832|NCT01634152|147241575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.026|STANDARD_ERROR_OF_MEAN|0.067||0.7034|TWO_SIDED|95.0|-0.158|0.107|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.107|-0.158|0.7034
73847833|NCT01634152|147241576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.776|STANDARD_ERROR_OF_MEAN|4.686||0.3083|TWO_SIDED|95.0|-4.419|13.97|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||13.970|-4.419|0.3083
73847834|NCT01634152|147241576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.743|STANDARD_ERROR_OF_MEAN|4.747||0.3179|TWO_SIDED|95.0|-4.571|14.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||14.057|-4.571|0.3179
73847835|NCT01634152|147241577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.567|STANDARD_ERROR_OF_MEAN|4.807||0.9061|TWO_SIDED|95.0|-8.866|10.001|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||10.001|-8.866|0.9061
73847836|NCT01634152|147241577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.107|STANDARD_ERROR_OF_MEAN|4.867||0.399|TWO_SIDED|95.0|-13.658|5.444|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||5.444|-13.658|0.3990
73847837|NCT01634152|147241578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|1.025||0.3542|TWO_SIDED|95.0|-2.959|1.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||1.060|-2.959|0.3542
73960453|NCT05565391|147456413|OTHER|||||||0.4241|||||||Quantile regression|||||||0.4241
73960454|NCT05565391|147456413|OTHER|||||||0.0281|||||||Quantile regression|||||||0.0281
73847838|NCT01634152|147241578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.502|STANDARD_ERROR_OF_MEAN|1.042||0.6298|TWO_SIDED|95.0|-2.545|1.541|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||1.541|-2.545|0.6298
73847839|NCT01634152|147241579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.032|STANDARD_ERROR_OF_MEAN|0.038||0.4066|TWO_SIDED|95.0|-0.107|0.043|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.043|-0.107|0.4066
73847840|NCT01634152|147241579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.049|STANDARD_ERROR_OF_MEAN|0.039||0.2032|TWO_SIDED|95.0|-0.125|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.027|-0.125|0.2032
73847841|NCT01634152|147241580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.051|STANDARD_ERROR_OF_MEAN|0.041||0.2064|TWO_SIDED|95.0|-0.131|0.028|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.028|-0.131|0.2064
73847842|NCT01634152|147241580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.061|STANDARD_ERROR_OF_MEAN|0.041||0.141|TWO_SIDED|95.0|-0.142|0.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.020|-0.142|0.1410
73847843|NCT01634152|147241581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.042||0.9869|TWO_SIDED|95.0|-0.083|0.082|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.082|-0.083|0.9869
73960455|NCT05565391|147456414|OTHER|||||||0.7682|||||||Quantile regression|||||||0.7682
73847844|NCT01634152|147241581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.043||0.873|TWO_SIDED|95.0|-0.077|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.090|-0.077|0.8730
73847845|NCT01634152|147241582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.006|STANDARD_ERROR_OF_MEAN|0.049||0.9043|TWO_SIDED|95.0|-0.103|0.091|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.091|-0.103|0.9043
73847846|NCT01634152|147241582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.05||0.7708|TWO_SIDED|95.0|-0.112|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.083|-0.112|0.7708
73960456|NCT05565391|147456415|OTHER|||||||0.0326|||||||Quantile regression|||||||0.0326
73960457|NCT05565391|147456416|OTHER||Hazard Ratio (HR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.09|0.31|||Cox proportional hazard model||Hazard ratio was estimated using unadjusted Cox proportional hazard model.|||0.31|0.09|<.0001
73960458|NCT05565391|147456416|OTHER||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.11|0.43|||Cox proportional hazard model||Hazard ratio was estimated using unadjusted Cox proportional hazard model.|||0.43|0.11|<.0001
73960459|NCT05565391|147456417|OTHER||Hazard Ratio (HR)|0.11|||<|0.0001|TWO_SIDED|95.0|0.06|0.22|||Cox proportional hazard model||Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.|||0.22|0.06|<.0001
73847847|NCT01634152|147241583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.036|STANDARD_ERROR_OF_MEAN|0.052||0.4864|TWO_SIDED|95.0|-0.139|0.066|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.066|-0.139|0.4864
73847848|NCT01634152|147241583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.053||0.7991|TWO_SIDED|95.0|-0.117|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.090|-0.117|0.7991
73847849|NCT01634152|147241584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.05||0.8884|TWO_SIDED|95.0|-0.092|0.106|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.106|-0.092|0.8884
73847850|NCT01634152|147241584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.051||0.8115|TWO_SIDED|95.0|-0.112|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.088|-0.112|0.8115
73847851|NCT01634152|147241585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.051||0.7498|TWO_SIDED|95.0|-0.084|0.117|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.117|-0.084|0.7498
73847852|NCT01634152|147241585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083|STANDARD_ERROR_OF_MEAN|0.052||0.1108|TWO_SIDED|95.0|-0.185|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.019|-0.185|0.1108
73847853|NCT01634152|147241586|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.059||0.8055|TWO_SIDED|95.0|-0.131|0.102|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.102|-0.131|0.8055
73899994|NCT04896229|147331425|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.02||0.005|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.005
73899995|NCT04896229|147331426|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.712|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.712
73847854|NCT01634152|147241586|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.071|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED|95.0|-0.189|0.047|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.047|-0.189|0.2360
73847855|NCT01634152|147241587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.017|STANDARD_ERROR_OF_MEAN|0.041||0.6748|TWO_SIDED|95.0|-0.097|0.063|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.063|-0.097|0.6748
73847856|NCT01634152|147241587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025|STANDARD_ERROR_OF_MEAN|0.041||0.5497|TWO_SIDED|95.0|-0.056|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.105|-0.056|0.5497
73847857|NCT01152437|147241588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.122||||0.0735|TWO_SIDED|90.0|0.018|0.844||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Regression, Logistic|Wald Chi-square test and Confidence Interval from logistic regression stratified by number of lines of palliative chemotherapy.||Null hypothesis is that the objective response rate (ORR) in KRAS wild-type patients treated with afatinib is less than or equal to the ORR in KRAS wild-type patients treated with cetuximab. Sample size is based on a 'pick the winner' approach assuming ORR for cetuximab of 12%, undesirable ORR for afatinib of 11% and desirable ORR for afatinib of 16%. As per 'pick the winner' approach, afatinib would be considered 'the winner' if the ORR for afatinib was greater than the ORR for cetuximab.||0.844|0.018|0.0735
73847858|NCT01152437|147241589|SUPERIORITY_OR_OTHER||Percentage of participants|12.0||||0.6394|TWO_SIDED|90.0|4.9|23.9||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Exact binomial test|||Null hypothesis is that the disease control rate is 10% in patients with KRAS mutation. Sample size calculation based on a 2-sided exact binomial test at 10% significance level to distinguish between the historical disease control rate of 10% and a desirable disease control rate for afatinib of 25%.||23.9|4.9|0.6394
73847859|NCT02317627|147241615|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD PASI from baseline to Week 12.||||||0.0282||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0282
73847860|NCT02317627|147241615|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID PASI from baseline to Week 12.||||||0.0035||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0035
73847861|NCT02317627|147241615|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID PASI from baseline to Week 12.||||||0.0261||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0261
73847862|NCT02317627|147241615|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change for all subjects' PASI from baseline to Week 12.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
73899996|NCT04896229|147331427|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.245|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.245
73960460|NCT05565391|147456418|OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.1|0.45|||Weighted Cox proportional hazard model||Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.|||0.45|0.10|<.0001
73847863|NCT02317627|147241616|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD PASI from baseline to Week 12.||||||0.0282||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0282
73847864|NCT02317627|147241616|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID PASI from baseline to Week 12.||||||0.0029||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0029
73847865|NCT02317627|147241616|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID PASI from baseline to Week 12.||||||0.0703||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0703
73847866|NCT02317627|147241616|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects' PASI from baseline to Week 12.||||||0.0002||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0002
73847867|NCT02317627|147241621|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to Week 4.||||||0.0064||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0064
73847868|NCT02317627|147241621|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to Week 4.||||||0.0479||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0479
73847869|NCT02317627|147241621|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to Week 4.||||||0.1513||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.1513
73847870|NCT02317627|147241621|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to Week 4.||||||0.0002||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0002
73847871|NCT02317627|147241622|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to Week 8.||||||0.0137||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0137
73847872|NCT02317627|147241622|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to Week 8.||||||0.0017||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0017
73847873|NCT02317627|147241622|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to Week 8.||||||0.0743||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0743
73847874|NCT02317627|147241622|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to Week 8.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
73847875|NCT02317627|147241623|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 4 weeks.||||||0.014||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0140
73847876|NCT02317627|147241623|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 4 weeks.||||||0.062||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0620
73847877|NCT02317627|147241623|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in 400 mg BID from baseline to 4 weeks.||||||0.262||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.2620
73847878|NCT02317627|147241623|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects from baseline to 4 weeks.||||||0.0008||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0008
73847879|NCT02317627|147241623|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 8 weeks.||||||0.0137||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0137
73847880|NCT02317627|147241623|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 8 weeks.||||||0.0064||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0064
73847881|NCT02317627|147241623|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to 8 weeks.||||||0.0743||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0743
73847882|NCT02317627|147241623|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects from baseline to 8 weeks.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
73899997|NCT04896229|147331428|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.282|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.282
73899998|NCT04896229|147331429|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.289|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.289
73899999|NCT04896229|147331430|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.296|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.296
73900000|NCT01848782|147331455|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.5|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||||0.7|-0.4|0.5
73900001|NCT01848782|147331456|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.8|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||||0.6|-0.5|0.8
73900002|NCT01848782|147331457|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.6|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||||0.7|-0.4|0.6
73900003|NCT01848782|147331458|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.8|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||||0.5|-0.6|0.8
73900004|NCT01848782|147331459|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis|||||0.2|-1.0|0.2
73900005|NCT00046891|147331460|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||t-test, 2 sided|||Total HSCS Area Under the Curve (AUC) scores between the two treatment arms.||||0.84
73900006|NCT00609362|147331492|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is un-adjusted. A priori threshold for significance: 0.05|t-test, 2 sided|||The minimum number of participants was determined by power calculations to be 44 (22 in each group), assuming a difference in change in BMD of 1.7%, a standard deviation of 2%, a power of 80%, and a level of significance of 5%.||||0.055
73960461|NCT02716324|147456420|SUPERIORITY||Beta Coefficient|0.001||||0.871|TWO_SIDED|95.0|-0.01|0.012|||GLS random-effects model|||Random effects models regressed VPRS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.||0.012|-0.010|.871
73960462|NCT02716324|147456421|SUPERIORITY||Beta coefficient|0.001||||0.499|TWO_SIDED|95.0|-0.002|0.004|||Random effects model|||Random effects models regressed GAS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.||0.004|-0.002|0.499
73960463|NCT02716324|147456422|SUPERIORITY|||||||0.718|||||||Chi-squared|||Differences in proportions between the two groups in use of any services were assessed using the Chi-square Test.||||0.718
73960464|NCT02716324|147456422|SUPERIORITY|||||||0.903|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services were assessed using the Chi-square Test.||||0.903
73960465|NCT02716324|147456422|SUPERIORITY|||||||0.915|||||||Chi-squared|||Differences in proportions between the two groups in use of any inpatient mental health services were assessed using the Chi-square Test.||||0.915
73960466|NCT02716324|147456423|SUPERIORITY|||||||0.31|||||||Chi-squared|||Differences in proportions between the two groups in use of any mental health services during the study period were assessed using the Chi-square Test.||||0.310
73960467|NCT02716324|147456423|SUPERIORITY|||||||0.251|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services during the study period were assessed using the Chi-square Test.||||0.251
73960468|NCT02716324|147456423|SUPERIORITY|||||||1|||||||Chi-squared|||Differences in proportions between the two groups in use of inpatient mental health services during the study period were assessed using the Chi-square Test.||||1.00
73900007|NCT00609362|147331493|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||t-test, 2 sided|||||||0.056
73900008|NCT00609362|147331494|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
73900009|NCT00548405|147331507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0084|TWO_SIDED|95.0|0.38|0.87||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariate was used.||0.87|0.38|0.0084
73900010|NCT00548405|147331508|SUPERIORITY_OR_OTHER||Rate ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.65||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.65|0.39|<0.0001
73900011|NCT00548405|147331509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.69|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.69|0.41|<0.0001
73900012|NCT00548405|147331510|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.||||<0.0001
73900013|NCT00548405|147331511|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Wei-Lachin|||Change at Year 2: the analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.||||0.0022
73900014|NCT00548405|147331512|SUPERIORITY_OR_OTHER|||||||0.1371|TWO_SIDED||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and Baseline T2 lesion volume was used.||||0.1371
73900015|NCT03102190|147331513|OTHER||||||||||||||||||The analysis of the safety endpoints will be presented with means and standard deviations of their occurrence within the study population. The safety of the drug will be determined by analyzing the rate of adverse events in both phases of the trial. An occurrence of 10% within the study population will be considered significant.|||
73900016|NCT02582684|147331514|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.9|||||TWO_SIDED|95.0|0.83|0.95|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.95|0.83|
73900017|NCT02582684|147331515|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|Proportion|0.89|||||TWO_SIDED|95.0|0.82|0.94|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.94|0.82|
74084706|NCT01503333|147722563|OTHER||parameter estimate|30.48|||<|0.001|TWO_SIDED||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||<.001
73900018|NCT02582684|147331516|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.85|||||TWO_SIDED|95.0|0.77|0.91|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.91|0.77|
73900019|NCT00402233|147331536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|||<|0.0001||95.0|-6.53|-2.26|||ANCOVA|||||-2.26|-6.53|<0.0001
73900020|NCT00402233|147331536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.41|||<|0.0001||95.0|-6.54|-2.28|||ANCOVA|||||-2.28|-6.54|<0.0001
73960469|NCT02716324|147456424|SUPERIORITY||Beta coefficient|0.0||||0.662|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.662
73900021|NCT00402233|147331536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.72|||<|0.0001||95.0|-6.91|-2.52|||ANCOVA|||||-2.52|-6.91|<0.0001
73900022|NCT00402233|147331537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.893||||||95.0|0.431|1.849|||Regression, Logistic|||||1.849|0.431|
73960470|NCT02716324|147456424|SUPERIORITY||Beta coefficient|0.001||||0.075|TWO_SIDED|95.0|0.0|0.002|||Random effects model|||Random effects models regressed Child PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.002|0.000|0.075
73960471|NCT02716324|147456425|SUPERIORITY||Beta coefficient|0.0||||0.707|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.707
73960472|NCT02716324|147456425|SUPERIORITY||Beta coefficient|0.0||||0.735|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Child PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.735
73960473|NCT02716324|147456426|SUPERIORITY||Beta coefficient|0.0||||0.735|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child PRO Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.735
73960474|NCT02716324|147456427|SUPERIORITY||Beta coefficient|0.0||||0.873|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Parent Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Parent-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.873
73960475|NCT02716324|147456427|SUPERIORITY||Beta coefficient|0.0||||0.888|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.888
73960476|NCT02716324|147456428|SUPERIORITY||Beta coefficient|0.0||||0.679|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Family Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Family Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.679
73960477|NCT02716324|147456429|SUPERIORITY||Beta coefficient|0.074||||0.495|TWO_SIDED|95.0|-0.164|0.311|||Random effects model|||Random effects models regressed Access Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.311|-0.164|0.495
73960478|NCT02716324|147456429|SUPERIORITY||Beta coefficient|-0.013||||0.885|TWO_SIDED|95.0|-0.217|0.191|||Random effects model|||Random effects models regressed Patient Family Centered Care Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.191|-0.217|0.885
73900023|NCT00402233|147331537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.885||||||95.0|0.424|1.845|||Regression, Logistic|||||1.845|0.424|
73900024|NCT00402233|147331537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.687||||||95.0|0.317|1.492|||Regression, Logistic|||||1.492|0.317|
73900025|NCT00402233|147331538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14||||0.014||95.0|0.23|2.04|||ANCOVA|||||2.04|0.23|0.014
73900026|NCT00402233|147331538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.03||95.0|0.094|1.9|||ANCOVA|||||1.9|0.094|0.03
73900027|NCT00402233|147331538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49||||0.0019||95.0|0.56|2.43|||ANCOVA|||||2.43|0.56|0.0019
73900028|NCT00402233|147331539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.39||95.0|-1.82|0.71|||ANCOVA|||||0.71|-1.82|0.39
73900029|NCT00402233|147331539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.37||95.0|-1.84|0.69|||ANCOVA|||||0.69|-1.84|0.37
73900030|NCT00402233|147331539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.48||95.0|-1.78|0.84|||ANCOVA|||||0.84|-1.78|0.48
74023272|NCT05817045|147599182|SUPERIORITY|SARS-CoV-2 rapid antigen test type: BinaxNOW|Cox Proportional Hazard|1.12|||||TWO_SIDED|95.0|0.801|1.561|||||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|Subgroup Analysis - Cox proportional hazards model for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (FAS)||1.561|0.801|
73960479|NCT02716324|147456429|SUPERIORITY||Beta coefficient|0.073||||0.527|TWO_SIDED|95.0|-0.182|0.328|||Random effects model|||Random effects models regressed Communication Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.328|-0.182|0.527
73960480|NCT02716324|147456429|SUPERIORITY||Beta coefficient|0.136||||0.285|TWO_SIDED|95.0|-0.138|0.41|||Random effects model|||Random effects models regressed Understanding Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.410|-0.138|0.285
73847883|NCT02317627|147241628|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 12 weeks.||||||0.004||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.004
73847884|NCT02317627|147241628|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 12 weeks.||||||0.007||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.007
73847885|NCT02317627|147241628|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to 12 weeks.||||||0.09||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.090
73847886|NCT02317627|147241628|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to 12 weeks.|||||<|0.001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.001
73847887|NCT02317627|147241629|SUPERIORITY|||||||0.004||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.004
73847888|NCT02317627|147241629|SUPERIORITY|||||||0.029||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.029
73847889|NCT02317627|147241629|SUPERIORITY|||||||0.084||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.084
73847890|NCT02317627|147241629|SUPERIORITY||||||<|0.001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.001
73847891|NCT00279214|147241634|SUPERIORITY_OR_OTHER|||||||0.238||95.0|||||Repeated Measures - propensity adjusted|||24-Hour p-value||||0.238
73900031|NCT02081248|147331597|SUPERIORITY|||||||0.37||||||Testing was performed at a significance level of 0.05|t-test, 2 sided|Two-sample t-test comparing mean QuIC-A scores performed using 150 degrees of freedom||The null hypothesis is that there is no difference in comprehension of the parent clinical trial, as measured by the QuIC-A, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Mean QuIC-A scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.37
73900032|NCT02081248|147331598|SUPERIORITY|||||||0.39||||||Testing performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' perception of their comprehension of the parent clinical trial, as measured by the QuIC-B, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median QuIC-B scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.39
73900033|NCT02081248|147331599|SUPERIORITY|||||||0.17||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' comprehension of the parent clinical trial, as measured by the DICCT, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median DICCT scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.17
73900034|NCT02081248|147331602|SUPERIORITY|||||||0.21||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' state anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median state anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.||||0.21
73847892|NCT00279214|147241634|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.281
73847893|NCT00279214|147241635|SUPERIORITY_OR_OTHER|||||||0.478||95.0||||P-value for 96 Hour Change from Baseline.|Mixed Models Analysis|Model: Outcome=Therapy + Sedative Indicator + Time + Therapy\*Time + Propensity Score||||||0.478
73847894|NCT00279214|147241636|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.442
73847895|NCT00279214|147241636|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.871
73847896|NCT00279214|147241637|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.704
73847897|NCT00279214|147241637|SUPERIORITY_OR_OTHER|||||||0.702||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.702
73847898|NCT00279214|147241638|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||6-Hour p-value|Repeated Measures - propensity adjusted|||||||0.061
73847899|NCT00279214|147241638|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||6-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.027
73847900|NCT00279214|147241639|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.242
73847901|NCT00279214|147241639|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||12-Hour p-value|Repeated Measures - propensity adjusted|||||||0.083
73900035|NCT02081248|147331602|SUPERIORITY|||||||0.25||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' trait anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median trait anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.||||0.25
73900036|NCT02081248|147331603|SUPERIORITY|||||||0.8||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in satisfaction with the consent process, as measured by a study-specific questionnaire, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median participant satisfaction scores were compared between arms, which should be equal under the null hypothesis.||||0.80
73900037|NCT02081248|147331604|SUPERIORITY|||||||0.73||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the main goal of the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the main goal of the study was compared between arms, which should be equal under the null hypothesis.||||0.73
73900038|NCT02081248|147331604|SUPERIORITY|||||||0.26||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find who to contact for questions between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find who to contact for questions was compared between arms, which should be equal under the null hypothesis.||||0.26
73900039|NCT02081248|147331604|SUPERIORITY|||||||0.74||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the risks and benefits section between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the risks and benefits section was compared between arms, which should be equal under the null hypothesis.||||0.74
73900040|NCT02081248|147331604|SUPERIORITY|||||||0.56||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find how to leave the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find how to leave the study was compared between arms, which should be equal under the null hypothesis.||||0.56
73900041|NCT02081248|147331604|SUPERIORITY|||||||0.79||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find study procedures between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find study procedures was compared between arms, which should be equal under the null hypothesis.||||0.79
73900042|NCT02081248|147331605|SUPERIORITY|||||||1||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 0901 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 0901 were compared between arms in participants considering enrollment, which should be equal under the null hypothesis.||||1.00
73900043|NCT02081248|147331605|SUPERIORITY|||||||0.77||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1101 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1101 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.77
73900044|NCT02081248|147331605|SUPERIORITY|||||||0.69||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1203 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1203 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.69
73900045|NCT02081248|147331605|SUPERIORITY|||||||0.26||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1301 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1501 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.26
73900046|NCT02927067|147331682|NON_INFERIORITY|Non-inferiority (NI) margin of primary efficacy endpoint was 7%. If lower limit of 95% confidence interval (CI) was greater than -7%, NI was assumed. Power calculation: Assuming 68% (maribavir), 60% (valganciclovir) participants achieve confirmed viremia clearance,494 participants (247 per group) would yield \>90% power to declare NI based on 2-group test of equivalence in proportions. Considering 10% dropout,550 participants (275 per group) were planned to be enrolled and randomized.|Difference in Percentage of Responders|-7.7|||||TWO_SIDED|95.0|-14.98|-0.36|||||Cochran-Mantel-Haenszel (CMH) weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for adjusted difference in percentage of responders (Maribavir-Valganciclovir), 95% CI, and p-value.|||-0.36|-14.98|
73900047|NCT02927067|147331683|NON_INFERIORITY|The non-inferiority margin of the key secondary efficacy endpoint was 7%. If the lower limit of the 95% CI was greater than -7%, then noninferiority (NI) was assumed. Because the NI of the primary efficacy endpoint was not established, the NI hypothesis of the key secondary endpoint was not tested formally.|Difference in Percentage of Responders|4.4|||||TWO_SIDED|95.0|-3.91|12.76|||||CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|||12.76|-3.91|
73900048|NCT02927067|147331684|SUPERIORITY||Difference in Percentage of Responders|8.0|||=|0.061|TWO_SIDED|95.0|-0.38|16.3||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||||16.30|-0.38|=0.061
73900049|NCT02927067|147331685|SUPERIORITY||Difference in Percentage of Responders|8.0|||=|0.061|TWO_SIDED|95.0|-0.38|16.3||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 8||16.30|-0.38|=0.061
73847902|NCT00279214|147241639|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.810
73960481|NCT02547922|147456474|SUPERIORITY||Geometric Mean Ratio|1.031||||0.9052|TWO_SIDED|95.0|0.621|1.713||The p-values presented are unadjusted and was compared with the respective adjusted significance level (α). If α is not displayed, no formal testing can be performed and the corresponding p-value was nominal.|Mixed Models Analysis||Geometric mean ratio \>1 favours placebo.|The model includes fixed effects for treatment group, visit, stratification factors, log-transformed 24-hour UPCR at baseline, and treatment-by-visit interaction. All data up to and including the date of discontinuation of study treatment were included in the analysis.||1.713|0.621|0.9052
73960482|NCT02547922|147456475|SUPERIORITY||Difference in estimates|-0.08||||0.9929|TWO_SIDED|95.0|-16.92|16.76||At Week 52, the p-values presented are unadjusted and will be compared to the respective adjusted significance level (α). If α is not displayed no formal testing can be performed and the corresponding p-value is nominal.|Cochran-Mantel-Haenszel|||The statistical analysis represents the estimated percentage of responders. The responder/non-responder rates (percentages), the difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach.||16.76|-16.92|0.9929
73960483|NCT02336438|147456480|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.99
73960484|NCT02336438|147456481|SUPERIORITY_OR_OTHER|||||||0.4922|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.4922
73847903|NCT00279214|147241639|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.623
73847904|NCT00279214|147241640|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.686
73847905|NCT00279214|147241640|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.575
73847906|NCT00279214|147241641|SUPERIORITY_OR_OTHER|||||||0.165||95.0|||||Repeated Measures - propensity adjusted|||||||0.165
73847907|NCT00279214|147241643|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.552
73847908|NCT00279214|147241643|SUPERIORITY_OR_OTHER|||||||0.129||95.0||||12-Hour p-value|Repeated Measures - propensity adjusted|||||||0.129
73847909|NCT00279214|147241643|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.030
73847910|NCT00279214|147241643|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.002
73960485|NCT02336438|147456482|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.77
73960486|NCT02336438|147456483|SUPERIORITY_OR_OTHER|||||||0.0156|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.0156
73960487|NCT02336438|147456484|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.020
73960488|NCT02336438|147456485|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.13
73960489|NCT00102063|147456488|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
73960490|NCT00102063|147456488|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
73960491|NCT00857649|147456516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.52||0.418|TWO_SIDED|95.0|-1.75|4.21|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||4.21|-1.75|0.418
73960492|NCT00857649|147456517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.92||0.603|TWO_SIDED|95.0|-2.3|1.34|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||1.34|-2.30|0.603
73960493|NCT00857649|147456518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.734|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||0.31|-0.22|0.734
73960494|NCT00857649|147456519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.017|TWO_SIDED|95.0|-3.29|-0.32|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||-0.32|-3.29|0.017
73847911|NCT00279214|147241645|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.128
73847912|NCT00279214|147241645|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.234
73847913|NCT01214837|147241658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-7.0|||||TWO_SIDED|95.0|-14.0|-1.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup A at 13 months of age.||-1|-14|
73847914|NCT01214837|147241658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-8.0|0.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup C at 13 months of age.||0|-8|
73847915|NCT01214837|147241658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup W at 13 months of age.||3|-3|
73847916|NCT01214837|147241658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup Y at 13 months of age.||4|-2|
73847917|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.5|||||TWO_SIDED|95.0|-6.1|5.0|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.||5|-6.1|
73847918|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.8|||||TWO_SIDED|95.0|3.0|10.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.||10.5|3|
73847919|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-11.9|6.0|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.||6|-11.9|
73847920|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.3|||||TWO_SIDED|95.0|-3.3|13.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.||13.7|-3.3|
73847921|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.4|||||TWO_SIDED|95.0|-7.5|2.3|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.||2.3|-7.5|
73847922|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.3|||||TWO_SIDED|95.0|-4.4|4.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.||4.7|-4.4|
73900050|NCT02927067|147331685|SUPERIORITY||Difference in Percentage of Responders|13.4|||=|0.001|TWO_SIDED|95.0|5.23|21.62||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 12||21.62|5.23|=0.001
73900051|NCT02927067|147331685|SUPERIORITY||Difference in Percentage of Responders|13.8|||<|0.001|TWO_SIDED|95.0|5.8|21.87||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 16||21.87|5.80|<0.001
73900052|NCT02927067|147331685|SUPERIORITY||Difference in Percentage of Responders|9.7|||=|0.014|TWO_SIDED|95.0|1.98|17.5||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 20||17.50|1.98|=0.014
73900053|NCT02927067|147331686|SUPERIORITY||Difference in Percentage of Responders|-7.3|||=|0.051|TWO_SIDED|95.0|-14.64|0.02||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 8||0.02|-14.64|=0.051
73960495|NCT00857649|147456520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.98||0.36|TWO_SIDED|95.0|-1.03|2.83|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||2.83|-1.03|0.360
73900054|NCT02927067|147331686|SUPERIORITY||Difference in Percentage of Responders|2.2|||=|0.606|TWO_SIDED|95.0|-6.05|10.37||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 12||10.37|-6.05|=0.606
73960496|NCT05190419|147456521|SUPERIORITY||Mean Difference (Net)|-35.4|STANDARD_ERROR_OF_MEAN|9.83|<|0.001|TWO_SIDED|95.0|-54.7|-16.0||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-16.0|-54.7|<0.001
73900055|NCT02927067|147331686|SUPERIORITY||Difference in Percentage of Responders|1.0|||=|0.809|TWO_SIDED|95.0|-7.27|9.31||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 20||9.31|-7.27|=0.809
73900056|NCT01727700|147331701|SUPERIORITY_OR_OTHER||Treatment difference|-6.26||||0.002|TWO_SIDED|95.0|-10.18|-2.34||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard deviation \[SD\] of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.||-2.34|-10.18|0.0020
73900057|NCT01727700|147331701|SUPERIORITY_OR_OTHER||Treatment difference|-9.85|||<|0.0001|TWO_SIDED|95.0|-13.84|-5.86||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard SD of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.||-5.86|-13.84|<0.0001
73900058|NCT01727700|147331702|SUPERIORITY_OR_OTHER||Treatment difference|-1.03||||0.0001|TWO_SIDED|95.0|-1.54|-0.52||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||||-0.52|-1.54|0.0001
73900059|NCT01727700|147331702|SUPERIORITY_OR_OTHER||Treatment difference|-1.02||||0.0002|TWO_SIDED|95.0|-1.54|-0.49||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||||-0.49|-1.54|0.0002
73900060|NCT01727700|147331703|SUPERIORITY_OR_OTHER||Treatment difference|-13.26||||0.0017|TWO_SIDED|95.0|-21.43|-5.08||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-5.08|-21.43|0.0017
73900061|NCT01727700|147331703|SUPERIORITY_OR_OTHER||Treatment difference|-19.37|||<|0.0001|TWO_SIDED|95.0|-27.7|-11.04||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-11.04|-27.70|<0.0001
73900062|NCT01727700|147331704|SUPERIORITY_OR_OTHER||Treatment difference|-0.8||||0.001|TWO_SIDED|95.0|-1.27|-0.33||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-0.33|-1.27|0.0010
73960497|NCT05190419|147456521|SUPERIORITY||Mean Difference (Net)|-43.9|STANDARD_ERROR_OF_MEAN|9.75|<|0.001|TWO_SIDED|95.0|-63.1|-24.8||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-24.8|-63.1|<0.001
73960498|NCT05190419|147456521|SUPERIORITY||Mean Difference (Net)|-46.4|STANDARD_ERROR_OF_MEAN|9.75|<|0.001|TWO_SIDED|95.0|-65.6|-27.3||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-27.3|-65.6|<0.001
73960499|NCT05323734|147456573|OTHER||Median Difference (Final Values)|-14.53||||0.0904|TWO_SIDED|95.0|-32.04|2.48|||Wilcoxon Rank-Sum|Wilcoxon Rank-Sum statistic is applied using a 2-sided significance level of 0.05.|The Hodges-Lehmann approach is applied for estimating 95% confidence interval.|||2.48|-32.04|0.0904
73960500|NCT05323734|147456574|OTHER||Difference in percentage|6.4||||0.3407|TWO_SIDED|95.0|-6.4|20.1|||Fisher Exact|||||20.1|-6.4|0.3407
73960501|NCT05323734|147456575|OTHER||Odds Ratio (OR)|0.88||||0.7069|TWO_SIDED|95.0|0.46|1.7|||Regression, Logistic||The estimated odds ratio of the ganaxolone group compared to the placebo group based on proportional odds logistic regression with treatment as a factor.|||1.70|0.46|0.7069
73960502|NCT05323734|147456576|OTHER||Odds Ratio (OR)|0.85||||0.6434|TWO_SIDED|95.0|0.42|1.72|||Regression, Logistic||The estimated odds ratio of the ganaxolone group compared to the placebo group based on proportional odds logistic regression with treatment as a factor.|||1.72|0.42|0.6434
73900063|NCT01727700|147331704|SUPERIORITY_OR_OTHER||MMRM|-0.92||||0.0002|TWO_SIDED|95.0|-1.41|-0.44||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-0.44|-1.41|0.0002
73900064|NCT01727700|147331705|SUPERIORITY_OR_OTHER||Response ratio|1.36||||0.0835|TWO_SIDED|95.0|0.98|1.88||P-value derived from Cochran-Mantel-Haenszel (CMH) General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio \> 1 favors aripiprazole.||||1.88|0.98|0.0835
73900065|NCT01727700|147331705|SUPERIORITY_OR_OTHER||Response ratio|1.61||||0.0014|TWO_SIDED|95.0|1.2|2.16||P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio \> 1 favors aripiprazole.||||2.16|1.20|0.0014
73900066|NCT01727700|147331706|SUPERIORITY_OR_OTHER||Discontinuation ratio|1.16||||0.9187|TWO_SIDED|95.0|0.19|7.05||Discontinuation ratio \< 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|||||7.05|0.19|0.9187
73900067|NCT01727700|147331706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.9576||||||Hazard ratio \< 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox|||||||0.9576
73900068|NCT01727700|147331706|SUPERIORITY_OR_OTHER||Discontinuation ratio|4.06||||0.0132|TWO_SIDED|95.0|1.1|14.95||Discontinuation ratio \< 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|||||14.95|1.10|0.0132
73900069|NCT01727700|147331706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.51||||0.0278||||||Hazard ratio \< 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox|||||||0.0278
73900070|NCT02484859|147331717|SUPERIORITY||||||>|0.69|||||||Wilcoxon (Mann-Whitney)|||Median intraoperative bleeding scores were compared with Wilcoxon test. In this pilot study the power analysis showed that a sample size of 44 patients in each group was sufficient to detect a difference of 0.2 in the mean (standard deviation of 0.4) with an 80% power with an alpha error of 0.05 and a beta error of 20%. The Shapiro-Wilk test was used to test the distribution of data.||||>0.69
73900071|NCT02484859|147331718|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73900072|NCT02484859|147331719|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||0.052
73900073|NCT02484859|147331720|SUPERIORITY|||||||0.05|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at arrrival to post anesthetic care unit (PACU) were similar.||||0.05
73900074|NCT02484859|147331720|SUPERIORITY|||||||0.55|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at discharge from post anesthetic care unit (PACU) were similar.||||0.55
73900075|NCT02484859|147331721|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
73960503|NCT00094575|147456577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.81|TWO_SIDED|95.0|0.77|1.22|||Log Rank||The HR was estimated by comparing Endovascular repair arm vs the Open repair arm.|The primary outcome was long-term, all-cause mortality. The sample size would provide 80% power to detect a 25% relative reduction in mortality at a two-sided alpha level of 0.05. The primary comparison was the main effects of Endovascular repair vs Open repair of AAA.||1.22|0.77|0.81
73960504|NCT00094575|147456578|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Chi-squared|||||||0.12
73960505|NCT00094575|147456579|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.81
73960506|NCT00094575|147456580|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
73960507|NCT00094575|147456581|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
73960508|NCT00094575|147456582|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Mixed Models Analysis|||Note: Since this is measuring change over time since baseline, values could be below 0.||||0.58
73960509|NCT00094575|147456583|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Mixed Models Analysis|||||||0.37
73960510|NCT00094575|147456584|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
73960511|NCT00961636|147456598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test was stratified by country||||||<0.001
73960512|NCT00961636|147456599|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Unconditional Miettinen and Nurminen|||||||<0.001
73960513|NCT03603717|147456600|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
73900076|NCT02054481|147331722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.4|||<|0.0001|TWO_SIDED|95.0|19.0|53.8|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||53.8|19.0|<0.0001
73900077|NCT02054481|147331723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.6||||0.0355|TWO_SIDED|95.0|1.0|28.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 12||28.2|1.0|0.0355
73900078|NCT02054481|147331723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.1||||0.0062|TWO_SIDED|95.0|6.0|36.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 24||36.2|6.0|0.0062
73900079|NCT02054481|147331724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.1||||0.0008|TWO_SIDED|95.0|11.3|42.9|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||42.9|11.3|0.0008
73900080|NCT02054481|147331725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.1||||0.0706|TWO_SIDED|95.0|-0.8|21.1|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||21.1|-0.8|0.0706
73900081|NCT02054481|147331726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.8||||0.03|TWO_SIDED|95.0|1.9|37.7|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||37.7|1.9|0.0300
73900082|NCT02054481|147331728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.2||||0.0072|TWO_SIDED|95.0|5.7|36.6|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||36.6|5.7|0.0072
73900083|NCT02054481|147331729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1844|||<|0.0001|TWO_SIDED|95.0|0.1|0.4|||Log Rank|||||0.4|0.1|<0.0001
73900084|NCT02320903|147331741|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was 0.16.|||
73900085|NCT02320903|147331741|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.22.|||
73960514|NCT03603717|147456601|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
73960515|NCT03603717|147456602|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||0.84
73960516|NCT03603717|147456603|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
73960517|NCT00732381|147456604|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||ANCOVA|||||||0.006
73960518|NCT00732381|147456605|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<.001
73960519|NCT01350804|147456612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0458|TWO_SIDED|95.0|1.0|3.2|||Regression, Logistic|||||3.2|1.0|0.0458
73960520|NCT01350804|147456612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.0152|TWO_SIDED|95.0|1.1|3.5|||Regression, Logistic|||||3.5|1.1|0.0152
73960521|NCT04411082|147456625|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
73847923|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-4.3|||||TWO_SIDED|95.0|-12.1|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.||3.4|-12.1|
73960522|NCT04411082|147456626|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
73847924|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.9|||||TWO_SIDED|95.0|-1.9|11.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.||11.8|-1.9|
73847925|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.04|||||TWO_SIDED|95.0|-3.7|3.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.||3.8|-3.7|
73847926|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.2|||||TWO_SIDED|95.0|-2.2|4.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.||4.8|-2.2|
73847927|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.3|||||TWO_SIDED|95.0|-8.4|7.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.||7.7|-8.4|
73847928|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|10.2|||||TWO_SIDED|95.0|3.4|17.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.||17.2|3.4|
73847929|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-1.7|3.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.||3.5|-1.7|
73847930|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-2.1|3.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.||3.5|-2.1|
73847931|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.1|||||TWO_SIDED|95.0|-9.7|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.||3.4|-9.7|
73900086|NCT02320903|147331742|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.|||
73900087|NCT02320903|147331742|OTHER|What was the within-group change over time effect size?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for teen report on this measure was d = 0.22.|||
73900088|NCT02320903|147331743|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.10.|||
73900089|NCT02320903|147331743|EQUIVALENCE|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired samples T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.28.|||
73900090|NCT02320903|147331744|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.16.|||
73960523|NCT04411082|147456627|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
73847932|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-1.5|9.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.||9.7|-1.5|
73847933|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|vaccine group difference|1.9|||||TWO_SIDED|95.0|-1.2|5.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.||5.7|-1.2|
73847934|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|2.5|||||TWO_SIDED|95.0|-0.2|6.3|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.||6.3|-0.2|
73900091|NCT02320903|147331744|EQUIVALENCE|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report was d = 0.21.|||
73900092|NCT02320903|147331745|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.62.|||
73900093|NCT02320903|147331745|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.23.|||
73900094|NCT02320903|147331746|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.|||
73900095|NCT02320903|147331746|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired samples T tests were used to measure within-groups change over time for teens.|Cohen's d for youth report was d = 0.26.|||
73900096|NCT02320903|147331747|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d =.12.|||
73900097|NCT02320903|147331748|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.81.|||
73960524|NCT04411082|147456628|SUPERIORITY||||||>|0.4839|||||||Fisher Exact|||||||>0.4839
73960525|NCT04411082|147456629|SUPERIORITY|||||||0.2065|||||||Fisher Exact|||||||0.2065
73960526|NCT04411082|147456630|SUPERIORITY|||||||0.4839|||||||Fisher Exact|||||||0.4839
73900098|NCT02320903|147331749|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.43.|||
73900099|NCT02320903|147331750|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report on this measure was d = 24.|||
73900100|NCT03386253|147331752|SUPERIORITY|||||||0.77||||||Group x time p value|ANOVA|||||||0.77
73900101|NCT00178503|147331753|SUPERIORITY_OR_OTHER||Linear trend P value|0.0|||=|0.001|||||||ANOVA|||Data were analyzed using SPSS-PC repeated measures one-way analysis of variance (ANOVA), with MPH dosing regimen as the within-subjects variable.||||=.001
73900102|NCT00178503|147331754|SUPERIORITY_OR_OTHER||Linear p|0.005||||0.005|||||||ANOVA|||||||.005
73900103|NCT00178503|147331755|SUPERIORITY_OR_OTHER||Linear p|0.0|||<|0.001||0.0|||||ANOVA|||||||<.001
73900104|NCT01122394|147331776|SUPERIORITY_OR_OTHER|||||||0.29|||||||robust regression|controlling for provider clustering||Robust regressions were performed||||0.29
73900105|NCT01122394|147331777|SUPERIORITY_OR_OTHER|||||||0.25|||||||Regression, Logistic|This analysis includes participants in pre-action and action/maintenance||||||0.25
73900106|NCT01122394|147331778|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
73900107|NCT01122394|147331779|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Linear|||||||0.81
73900108|NCT01122394|147331780|SUPERIORITY_OR_OTHER|||||||0.12|||||||Regression, Linear|||||||0.12
73960527|NCT04411082|147456631|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
73960528|NCT04411082|147456632|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
73971024|NCT04119843|147482208|SUPERIORITY|Reader success of the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|0.909|<|0.001|TWO_SIDED|95.0|0.766|1.267|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 2||1.267|0.766|<0.001
73960529|NCT03622593|147456684|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|1.5|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|97.5|-0.1|3.2|||||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||3.2|-0.1|
73960530|NCT03622593|147456684|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|97.5|-1.1|2.1|||||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.1|-1.1|
74023273|NCT03905928|147599226|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise general linear model conducted in FSL software using a one-sample t-test on the tobacco\>strawberry condition contrasts conducted at the subject-level.|A whole-brain, one-sample t-test was used with a voxel threshold p \<.001 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
73900109|NCT02446743|147331781|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[(Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine Group Difference|77.0|||||TWO_SIDED|95.0|68.1|84.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||84.1|68.1|
73847935|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||TWO_SIDED|95.0|-6.3|-0.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.||-0.2|-6.3|
73847936|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.2|||||TWO_SIDED|95.0|-6.2|0.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.||0.2|-6.2|
73900110|NCT02446743|147331781|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|60.0|||||TWO_SIDED|95.0|49.9|69.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||69.2|49.9|
73900111|NCT02446743|147331781|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|68.0|||||TWO_SIDED|95.0|60.5|73.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||73.5|60.5|
73900112|NCT02446743|147331781|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|9.0|||||TWO_SIDED|95.0|5.3|14.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.8|5.3|
73900113|NCT02446743|147331781|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10 vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|14.0|||||TWO_SIDED|95.0|4.9|24.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.2|4.9|
73900114|NCT02446743|147331781|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|10.0|||||TWO_SIDED|95.0|4.3|15.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||15.9|4.3|
73900115|NCT02446743|147331782|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|25.0|||||TWO_SIDED|95.0|18.2|31.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||31.4|18.2|
73847937|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||TWO_SIDED|95.0|-7.1|1.6|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.||1.6|-7.1|
73847938|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-5.5|||||TWO_SIDED|95.0|-11.3|-0.9|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.||-0.9|-11.3|
73847939|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-1.7|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.||3.4|-1.7|
73900116|NCT02446743|147331782|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[(Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine groups difference|22.0|||||TWO_SIDED|95.0|13.2|30.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||30.1|13.2|
73900117|NCT02446743|147331782|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|30.0|||||TWO_SIDED|95.0|20.0|39.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||39.6|20.0|
73900118|NCT02446743|147331782|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-3.4|11.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.9|-3.4|
73900119|NCT02446743|147331782|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1(V72\_41)\]|vaccine group differences|12.0|||||TWO_SIDED|95.0|0.33|24.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.2|0.33|
73900120|NCT02446743|147331782|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1(V72P10)\]|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-10.0|9.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.5|-10.0|
73900121|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|22.0|||||TWO_SIDED|95.0|16.5|28.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||28.6|16.5|
73900122|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|14.6|28.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||28.9|14.6|
73900123|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|26.0|||||TWO_SIDED|95.0|16.4|35.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||35.3|16.4|
73900124|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|68.0|||||TWO_SIDED|95.0|60.8|73.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||73.7|60.8|
73900125|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|74.0|||||TWO_SIDED|95.0|65.3|81.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||81.3|65.3|
73900126|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|64.0|||||TWO_SIDED|95.0|53.6|72.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||72.3|53.6|
73900127|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|9.0|||||TWO_SIDED|95.0|3.7|14.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||14.0|3.7|
73900128|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|7.0|||||TWO_SIDED|95.0|3.3|12.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.3|3.3|
73900129|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|4.5|22.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||22.0|4.5|
74084707|NCT01503333|147722564|OTHER||parameter estimate|24.48|||<|0.001|TWO_SIDED||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||<.001
73960531|NCT03622593|147456684|SUPERIORITY||Adjusted mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.83||0.1718|TWO_SIDED|97.5|-0.7|3.0||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||3.0|-0.7|0.1718
73960532|NCT03622593|147456684|SUPERIORITY||Adjusted mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4602|TWO_SIDED|97.5|-1.2|2.4||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||2.4|-1.2|0.4602
73960533|NCT03622593|147456684|SUPERIORITY||Adjusted mean difference|1.5|STANDARD_ERROR_OF_MEAN|0.73||0.0361|TWO_SIDED|97.5|-0.1|3.2||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||3.2|-0.1|0.0361
73847940|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-2.1|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.||3.4|-2.1|
73847941|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.9|||||TWO_SIDED|95.0|-4.2|8.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.||8.2|-4.2|
73847942|NCT01214837|147241665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.5|||||TWO_SIDED|95.0|-1.4|10.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.||10.5|-1.4|
73847943|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.77|1.13|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.||1.13|0.77|
73900130|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|5.0|||||TWO_SIDED|95.0|-3.4|12.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.8|-3.4|
73900131|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|9.0|||||TWO_SIDED|95.0|-3.3|21.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||21.4|-3.3|
73847944|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.83|1.25|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.||1.25|0.83|
73847945|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.14|||||TWO_SIDED|95.0|0.93|1.4|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.||1.4|0.93|
73847946|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.25|||||TWO_SIDED|95.0|1.01|1.55|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.||1.55|1.01|
73847947|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||TWO_SIDED|95.0|0.62|0.96|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.||0.96|0.62|
73847948|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.75|1.18|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.||1.18|0.75|
73847949|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.86|1.21|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.||1.21|0.86|
73847950|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5|GMC ratio|1.07|||||TWO_SIDED|95.0|0.89|1.29|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.||1.29|0.89|
73847951|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||TWO_SIDED|95.0|0.69|1.04|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.||1.04|0.69|
73847952|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.88|1.37|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.||1.37|0.88|
73847953|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||TWO_SIDED|95.0|0.69|1.05|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.||1.05|0.69|
73847954|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.||1.3|0.83|
73847955|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.||0.95|0.67|
73847956|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.||1.25|0.87|
74084708|NCT01503333|147722565|OTHER||parameter estimate|3.19|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
74023274|NCT03905928|147599227|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise repeated measures ANOVA conducted using FSL software on activation from baseline to post-intervention that differ by the nicotine groups (18 mg/ml vs. 0 mg/ml) for the tobacco\>strawberry condition contrasts calculated at the subject-level. The means and standard deviations presented are the average post-pre scan difference scores of the BOLD percentage signal change of tobacco \> strawberry contrasts for each group.|A whole-brain, repeated measures ANOVA was used with a voxel threshold p \<.025 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
74023275|NCT03905928|147599228|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise repeated measures ANOVA conducted using FSL software on activation from baseline to post-intervention between the flavor groups (tobacco vs. strawberry) for the tobacco\>strawberry condition contrasts calculated at the subject-level. The means and standard deviations presented are the average post-pre scan difference scores of the BOLD percentage signal change of tobacco \> strawberry contrasts for each group.|A whole-brain, repeated measures ANOVA was used with a voxel threshold p \<.025 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
73847957|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.79|||||TWO_SIDED|95.0|0.66|0.96|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.||0.96|0.66|
73847958|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.87|1.31|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.||1.31|0.87|
73847959|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.84|1.27|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.||1.27|0.84|
73847960|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.||1.3|0.83|
73847961|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.||0.87|0.59|
73847962|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.89|1.36|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.||1.36|0.89|
73847963|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.83|1.27|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.||1.27|0.83|
73847964|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.97|||||TWO_SIDED|95.0|0.77|1.21|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.||1.21|0.77|
73847965|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.||1.22|0.82|
73847966|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.86|1.32|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.||1.32|0.86|
73847967|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||TWO_SIDED|95.0|0.62|0.97|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.||0.97|0.62|
74023276|NCT03905928|147599229|SUPERIORITY|||||||0.573|||||||ANOVA|||We conducted a one-way ANOVA to compare the change in e-cigarette dependence (week 4 - week 2 PSECDI difference score) between the four e-cigarette groups.||||0.573
73960534|NCT03622593|147456684|SUPERIORITY||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.73||0.493|TWO_SIDED|97.5|-1.1|2.1||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.1|-1.1|0.4930
73960535|NCT03622593|147456685|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab Q8W and the active comparator (aflibercept Q8W) arms was greater than -10%, then faricimab Q8W was considered non-inferior to aflibercept.|Difference in CMH Weighted Percentage|-2.6|||||TWO_SIDED|97.5|-12.6|7.4||||||This analysis is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||7.4|-12.6|
73847968|NCT01214837|147241666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.89|||||TWO_SIDED|95.0|0.7|1.13|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.||1.13|0.7|
73847969|NCT00939107|147241676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|||>|0.05||95.0|0.2|2.8|||t-test, 2 sided|||||2.8|0.2|>0.05
73847970|NCT01747915|147241699|SUPERIORITY||Least Square (LS) Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.088||0.8121|TWO_SIDED|95.0|-0.15|0.19|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.||0.19|-0.15|0.8121
73847971|NCT01747915|147241699|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.088||0.8889|TWO_SIDED|95.0|-0.19|0.16|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.||0.16|-0.19|0.8889
73847972|NCT01747915|147241700|SUPERIORITY||Odds Ratio (OR)|1.095||||0.7973|TWO_SIDED|95.0|0.548|2.186||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic|||||2.186|0.548|0.7973
73847973|NCT01747915|147241700|SUPERIORITY||Odds Ratio (OR)|0.934||||0.8474|TWO_SIDED|95.0|0.465|1.877||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic|||||1.877|0.465|0.8474
73847974|NCT00988156|147241701|SUPERIORITY_OR_OTHER|||||||0.249|||||||ANCOVA|||||||0.2490
73847975|NCT00988156|147241702|SUPERIORITY_OR_OTHER|||||||0.9017|||||||Cochran-Mantel-Haenszel|||||||0.9017
73847976|NCT01772550|147241709|NON_INFERIORITY_OR_EQUIVALENCE|A 95% upper confidence bound for the observed difference in percentages of images with acceptable quality between the control catheter and evaluation catheter was calculated using the Score method. The 20 G BD Nexiva™ Diffusics™ can be considered non-inferior for acceptable image quality if this 95% upper confidence bound is smaller than 15% (i.e. C - D \< 15% with 95% confidence). The non-inferiority margin was 15%.|Risk Difference (RD)|0.0|||||ONE_SIDED|95.0||2.6|||||The difference in percent of acceptable image quality is used as an estimate. The Score method was used to estimate the upper 95% confidence limit.|Only the percent of acceptable image quality from the randomized test and reference catheter groups were considered for this statistical analysis. If C is the percentage of acceptable quality images with the control catheter, and D is the percentage of images of acceptable quality with the evaluation catheter, and the non-inferiority criteria is 15%, the hypotheses to be tested are as follows: H0: C - D \> or = 15%; H1: C - D \< 15%.||2.6||
73847977|NCT01815424|147241721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.52|||<|0.0001|TWO_SIDED|95.0|6.03|32.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||32.77|6.03|<0.0001
73847978|NCT01815424|147241721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.27|||<|0.0001|TWO_SIDED|95.0|2.46|11.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||11.86|2.46|<0.0001
73847979|NCT01815424|147241722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|41.71|||<|0.0001|TWO_SIDED|95.0|14.84|151.11||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||151.11|14.84|<0.0001
73847980|NCT01815424|147241722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.97|||<|0.0001|TWO_SIDED|95.0|4.06|25.17||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||25.17|4.06|<0.0001
73960536|NCT03622593|147456685|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab PTI and the active comparator (aflibercept Q8W) arms was greater than -10%, then faricimab PTI was considered non-inferior to aflibercept.|Difference in CMH Weighted Percentage|-3.5|||||TWO_SIDED|97.5|-13.4|6.3||||||This analysis is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||6.3|-13.4|
73960537|NCT03622593|147456685|SUPERIORITY||Difference in CMH Weighted Percentage|-5.4||||0.3009|TWO_SIDED|97.5|-16.9|6.1||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||6.1|-16.9|0.3009
73960538|NCT03622593|147456685|SUPERIORITY||Difference in CMH Weighted Percentage|-6.9||||0.1735|TWO_SIDED|97.5|-18.3|4.4||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||4.4|-18.3|0.1735
73960539|NCT03622593|147456685|SUPERIORITY||Difference in CMH Weighted Percentage|-2.6||||0.5757|TWO_SIDED|97.5|-12.6|7.4||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||7.4|-12.6|0.5757
73960540|NCT03622593|147456685|SUPERIORITY||Difference in CMH Weighted Percentage|-3.5||||0.4293|TWO_SIDED|97.5|-13.4|6.3||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||6.3|-13.4|0.4293
73960541|NCT03622593|147456688|OTHER||Difference in CMH Weighted Percentage|3.5|||||TWO_SIDED|95.0|-4.0|11.1||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||11.1|-4.0|
73960542|NCT03622593|147456688|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-9.1|5.2||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.2|-9.1|
73960543|NCT03622593|147456688|OTHER||Difference in CMH Weighted Percentage|5.4|||||TWO_SIDED|95.0|-2.5|13.4||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||13.4|-2.5|
73960544|NCT03622593|147456688|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-8.9|6.8||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||6.8|-8.9|
73960545|NCT03622593|147456688|OTHER||Difference in CMH Weighted Percentage|3.8|||||TWO_SIDED|95.0|-2.7|10.3||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||10.3|-2.7|
73960546|NCT03622593|147456688|OTHER||Difference in CMH Weighted Percentage|-0.7|||||TWO_SIDED|95.0|-7.3|5.9||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.9|-7.3|
73960547|NCT03622593|147456688|OTHER||Difference in CMH Weighted Percentage|0.7|||||TWO_SIDED|95.0|-3.8|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||5.2|-3.8|
73960548|NCT03622593|147456688|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-4.9|4.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.2|-4.9|
73960549|NCT03622593|147456693|OTHER||Difference in CMH Weighted Percentage|0.2|||||TWO_SIDED|95.0|-8.5|8.9||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||8.9|-8.5|
73960550|NCT03622593|147456693|OTHER||Difference in CMH Weighted Percentage|-3.5|||||TWO_SIDED|95.0|-11.8|4.8||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.8|-11.8|
73960551|NCT03622593|147456693|OTHER||Difference in CMH Weighted Percentage|2.2|||||TWO_SIDED|95.0|-6.9|11.4||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||11.4|-6.9|
73960552|NCT03622593|147456693|OTHER||Difference in CMH Weighted Percentage|-0.8|||||TWO_SIDED|95.0|-9.8|8.1||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||8.1|-9.8|
73960553|NCT03622593|147456693|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-6.2|8.5||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||8.5|-6.2|
73960554|NCT03622593|147456693|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-8.3|6.2||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||6.2|-8.3|
73960555|NCT03622593|147456693|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-3.8|6.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||6.2|-3.8|
73960556|NCT03622593|147456693|OTHER||Difference in CMH Weighted Percentage|0.2|||||TWO_SIDED|95.0|-4.8|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.2|-4.8|
73960557|NCT03622593|147456698|OTHER||Difference in CMH Weighted Percentage|0.3|||||TWO_SIDED|95.0|-1.6|2.1||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.1|-1.6|
73960558|NCT03622593|147456698|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-1.8|1.9||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.9|-1.8|
73960559|NCT03622593|147456698|OTHER||Difference in CMH Weighted Percentage|-0.1|||||TWO_SIDED|95.0|-2.3|2.1||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.1|-2.3|
73960560|NCT03622593|147456698|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.4|1.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.9|-2.4|
74023277|NCT03905928|147599231|SUPERIORITY|||||||0.022|||||||ANOVA|||We conducted a one-way ANOVA to compare changes in self-reported craving across all groups.||||.022
74023278|NCT02688647|147599241|SUPERIORITY|||||||0.5733|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 38.85 (95% CI: -126.99, 204.69) mL||||0.5733
74023279|NCT02688647|147599241|SUPERIORITY|||||||0.6967|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -39.96 (95% CI: -288.63, 208.71) mL||||0.6967
74023280|NCT02688647|147599241|SUPERIORITY|||||||0.5003|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 94.16 (95% CI: -1103.56, 1291.88) mL||||0.5003
74023281|NCT02688647|147599241|SUPERIORITY|||||||0.4866|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||No Prior Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = -34.13 (95% CI: -137.08, 68.82)||||0.4866
74023282|NCT02688647|147599244|SUPERIORITY|GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 1.88 (95% CI: -2.69, 6.45)||||||0.3391|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.3391
74023283|NCT02688647|147599244|SUPERIORITY|GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -1.72 (95% CI: -8.13, 4.69)||||||0.5201|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.5201
74023284|NCT02688647|147599244|SUPERIORITY|GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 2.48 (95% CI: -23.84, 28.81)||||||0.4426|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.4426
74023285|NCT02688647|147599244|SUPERIORITY|No Prior Use of Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = 8.70 (95% CI: -78.76, -96.17)||||||0.426|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.4260
74023286|NCT02688647|147599254|SUPERIORITY|Cox Regression||||||0.8561|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.86 (0.16, 4.48)||||0.8561
74023287|NCT02688647|147599254|SUPERIORITY|Cox Regression||||||0.8608|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.87 (95% CI: 0.17, 4.33)||||0.8608
74084709|NCT02327325|147722701|SUPERIORITY||Mean Difference (Final Values)|-2.94||||0.08|TWO_SIDED|95.0|-6.24|0.35|||Mixed Models Analysis|||This is the comparison between physical activity only and the wait list group. Rejection of the null hypothesis means that the physical activity group had greater improvement than the wait list group.||0.35|-6.24|0.08
73900132|NCT02446743|147331784|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-6.4|14.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.5|-6.4|
73900133|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|10.1|20.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.9|10.1|
74023288|NCT02688647|147599255|SUPERIORITY|Cox Regression||||||0.0084|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.34 (95% CI: 0.14, 0.79)||||0.0084
74023289|NCT02688647|147599255|SUPERIORITY|Cox Regression||||||0.0508|TWO_SIDED|95.0|||||Log Rank|||Hazard Ratio: 0.47 (95% CI: 0.22, 1.03)||||0.0508
74023290|NCT02688647|147599257|SUPERIORITY|Cox Regression||||||0.4251|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.34 (95% CI: 0.02, 5.54)||||0.4251
74023291|NCT02688647|147599257|SUPERIORITY|Cox Regression||||||0.3294|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.27 (95% CI: 0.02, 4.45)||||0.3294
74023292|NCT01773473|147599273|NON_INFERIORITY_OR_EQUIVALENCE|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.01|0.35||||||||0.35|-0.01|
74023293|NCT02203149|147599323|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8|||||TWO_SIDED|95.0|-14.5|10.0|||Miettinen and Nurminen Method|||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.||10.0|-14.5|
74023294|NCT02203149|147599324|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-6.0|2.8|||Miettinen and Nurminen Method|||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.||2.8|-6.0|
74023295|NCT01478958|147599340|SUPERIORITY_OR_OTHER|||||||0.238||||||Overall diet effect. No post-hoc analyses required. Adjusted for multiple comparisons.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI, age, gender and intervention diet used as prognostic factors in model.||To detect a 2% inter-group difference in FMD (primary outcome) using a SD of 2.3, 90% power and 5% significance level, n=171 participants were required (n=57 per group), increasing to n=228 to include a 25% dropout rate.||||0.238
74023296|NCT01478958|147599340|SUPERIORITY_OR_OTHER|||||||0.021||||||Effect of the SFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||0.021
74084710|NCT02327325|147722701|SUPERIORITY||Mean Difference (Final Values)|-3.26||||0.06|TWO_SIDED|95.0|-6.69|0.06|||Mixed Models Analysis|||This is the comparison of the PA \& CBT group to the wait list group. Rejection of the null hypothesis means that the PA + CBT group was superior on this outcome to the wait list group.||0.06|-6.69|0.06
74084711|NCT02327325|147722702|SUPERIORITY||Mean Difference (Net)|-6.11||||0.07|TWO_SIDED|95.0|-12.85|0.64|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||0.64|-12.85|0.07
73847981|NCT01815424|147241723|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-71.54|STANDARD_ERROR_OF_MEAN|8.461|<|0.0001|TWO_SIDED|95.0|-88.2|-54.87||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-54.87|-88.20|<0.0001
73847982|NCT01815424|147241723|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-52.12|STANDARD_ERROR_OF_MEAN|8.416|<|0.0001|TWO_SIDED|95.0|-68.7|-35.55||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-35.55|-68.70|<0.0001
73847983|NCT01815424|147241724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|70.31|||<|0.0001|TWO_SIDED|95.0|13.38|267.15||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||267.15|13.38|<0.0001
73847984|NCT01815424|147241724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.44|||<|0.0001|TWO_SIDED|95.0|4.31|79.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||79.62|4.31|<0.0001
73847985|NCT01815424|147241725|SUPERIORITY_OR_OTHER||Least square mean difference|-7.52|STANDARD_ERROR_OF_MEAN|0.913|<|0.0001|TWO_SIDED|95.0|-9.32|5.72||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||5.72|-9.32|<0.0001
73847986|NCT01815424|147241725|SUPERIORITY_OR_OTHER||Least square mean difference|-5.45|STANDARD_ERROR_OF_MEAN|0.907|<|0.0001|TWO_SIDED|95.0|-7.24|-3.67||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-3.67|-7.24|<0.0001
73847987|NCT01815424|147241726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|114.4|||<|0.0001|TWO_SIDED|95.0|8.95|2657.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant,only then subsequent comparison was tested at the below specified significance level.||2657.62|8.95|<0.0001
73847988|NCT01815424|147241726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|35.37|||<|0.0001|TWO_SIDED|95.0|3.47|1084.02||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||1084.02|3.47|<0.0001
73900134|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|12.0|||||TWO_SIDED|95.0|7.5|18.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||18.1|7.5|
73900135|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|12.3|29.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||29.9|12.3|
73900136|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|66.0|||||TWO_SIDED|95.0|59.6|72.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||72.4|59.6|
73847989|NCT01815424|147241727|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||||<0.0001
73847990|NCT01815424|147241727|SUPERIORITY_OR_OTHER|||||||0.0386||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||||0.0386
73847991|NCT01815424|147241728|SUPERIORITY_OR_OTHER||Least square mean difference|-5.09|STANDARD_ERROR_OF_MEAN|0.709|<|0.0001|TWO_SIDED|95.0|-6.49|-3.7||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-3.70|-6.49|<0.0001
73847992|NCT01815424|147241728|SUPERIORITY_OR_OTHER||Least square mean difference|-4.2|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|-5.59|-2.81||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-2.81|-5.59|<0.0001
73847993|NCT01815424|147241729|SUPERIORITY_OR_OTHER||Least square mean of difference|-41.23|STANDARD_ERROR_OF_MEAN|15.977||0.0113|TWO_SIDED|95.0|-72.91|-9.54||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-9.54|-72.91|0.0113
73847994|NCT01815424|147241729|SUPERIORITY_OR_OTHER||Least square mean of difference|-22.89|STANDARD_ERROR_OF_MEAN|16.01||0.1558|TWO_SIDED|95.0|-54.64|8.86||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||8.86|-54.64|0.1558
73900137|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|70.0|||||TWO_SIDED|95.0|60.8|77.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||77.0|60.8|
73900138|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|65.0|||||TWO_SIDED|95.0|55.2|73.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||73.7|55.2|
73847995|NCT01127633|147241790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority margin for this hypothesis was specified as 50% of the treatment difference observed at the end of the feeder study. If the lower limit of the confidence interval (CI) was greater than 0, the noninferiority criterion was met, indicating that at least 50% of the treatment difference observed at the end of the feeder studies was maintained at specified time points in the delayed-start period.|Median Difference (Net)|-0.02||||0.974|TWO_SIDED|95.0|-1.14|1.11|||Mixed Models Analysis|||||1.11|-1.14|0.974
74084712|NCT02327325|147722702|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.28|TWO_SIDED|95.0|-11.69|3.48|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.||3.48|-11.69|0.28
73847996|NCT00688467|147241802|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|26.0|STANDARD_DEVIATION|27.377||0.411|||||||ANOVA|||||||0.411
73847997|NCT00688467|147241803|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|23.3|STANDARD_DEVIATION|0.306||0.292|||||||ANOVA|||||||0.292
73847998|NCT00688467|147241805|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|-1.7|STANDARD_DEVIATION|16.261||0.927|||||||ANOVA|||||||0.927
73847999|NCT00688467|147241806|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|4.3|STANDARD_DEVIATION|7.398||0.645|||||||ANOVA|||||||0.645
73848000|NCT01343888|147241867|SUPERIORITY_OR_OTHER||Koch's method|27.5|||<|0.0001|TWO_SIDED|95.0|17.9|37.0||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||37.0|17.9|<0.0001
73848001|NCT01343888|147241867|SUPERIORITY_OR_OTHER||Koch's methond|28.6|||<|0.0001|TWO_SIDED|95.0|19.0|38.2||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||38.2|19.0|<0.0001
73848002|NCT01343888|147241867|SUPERIORITY_OR_OTHER||Koch's method|-1.0|||||TWO_SIDED|95.0|-7.9|5.8|||||adjusted for genotype and race using Koch's method, with continuity correction|||5.8|-7.9|
73848003|NCT01343888|147241868|SUPERIORITY_OR_OTHER||Koch's method|27.1|||<|0.0001|TWO_SIDED|95.0|17.5|36.7||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||36.7|17.5|<0.0001
73848004|NCT01343888|147241868|SUPERIORITY_OR_OTHER||Koch's method|27.8|||<|0.0001|TWO_SIDED|95.0|18.2|37.4||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||37.4|18.2|<0.0001
73848005|NCT01343888|147241868|SUPERIORITY_OR_OTHER||Koch's method|-0.6|||||TWO_SIDED|95.0|-7.6|6.3|||||adjusted for genotype and race using Koch's method, with continuity correction|||6.3|-7.6|
73848006|NCT01990742|147241878|OTHER||||||>|0.05|||||||MOnte carlo simulation|||||||>0.05
73848007|NCT01990742|147241879|OTHER||||||>|0.05|||||||Monte carlo simulation|||||||>0.05
73848008|NCT01990742|147241880|OTHER||||||>|0.05|||||||Monte carlo simulation|||||||>0.05
73960561|NCT03622593|147456698|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-1.9|4.5||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.5|-1.9|
73848009|NCT02261961|147241895|SUPERIORITY||Slope|-0.24275|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
73848010|NCT02261961|147241896|SUPERIORITY||Slope|1.3707|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
73848011|NCT02261961|147241899|SUPERIORITY||Slope|-0.35579|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
73848012|NCT02261961|147241900|SUPERIORITY||Slope|0.004493|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
73848013|NCT02261961|147241901|SUPERIORITY||Slope|0.870653|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
73848014|NCT02261961|147241902|SUPERIORITY||Slope|-0.38664|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
73848015|NCT02261961|147241903|SUPERIORITY||Slope|0.335124|||>|0.05|TWO_SIDED||||||ANCOVA|||Outcomes were compared as percent change from the baseline measure using multiple methods by a blinded statistician. Differences between groups were assessed using ANCOVA, Welch's t-test, and Wilcoxon. No significant differences were found between groups for any outcome regardless of method used.||||>0.05
73848016|NCT02261961|147241905|SUPERIORITY||Slope|0.03145|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
73848017|NCT02261961|147241906|SUPERIORITY||Slope|-0.43902|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
73848018|NCT02261961|147241916|SUPERIORITY||Slope|-0.07603|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
73848019|NCT02261961|147241935|SUPERIORITY||Slope|-0.4745|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
73848020|NCT02394561|147241963|NON_INFERIORITY|The difference in percentage of patients achieving PASI 90 response between the Cw6-positive cohort and the Cw6-negative cohort was H0 = Cw6-positive minus Cw6-negative ≥0.12 and HA = Cw6-positive minus Cw6-negative was \< 0.12. The percentage of PASI 90 response by cohort as well as the difference between cohort together with 97.5% upper CI was provided using Clopper Pearson CI method.|difference|-1.3|||||TWO_SIDED|95.0|-8.8|6.2||||||||6.2|-8.8|
73848021|NCT02394561|147241966|OTHER|difference between cohorts for PASI 90 using Kaplan-Meier estimate||||||0.1295|||||||Log Rank|||||||0.1295
73848022|NCT02394561|147241966|OTHER|||||||0.447||||||difference between cohorts for PASI 75 using Kaplan-Meier estimate|Log Rank|||||||0.4470
73848023|NCT02394561|147241967|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|At all time points||||||<.0001
73848024|NCT02394561|147241968|SUPERIORITY||||||<|0.0001||||||All time points|Wilcoxon (Mann-Whitney)|||||||<.0001
73848025|NCT01854528|147242003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.26|||<|0.001|TWO_SIDED|95.0|21.09|47.42|||Stratum adjusted Mantel-Haenszel|||P-value for the difference in sustained virologic response rates 12 weeks after the last dose between treatment groups with HCV subgenotype (1a, non-1a) from stratum adjusted Mantel-Haenszel with previous type of response to pegIFN/RBV treatment (relapser, partial or null responder) as strata.||47.42|21.09|<0.001
73848026|NCT01854528|147242004|SUPERIORITY_OR_OTHER||LS mean difference|8.64|||<|0.001|TWO_SIDED|95.0|5.43|11.85|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.||11.85|5.43|<0.001
73848027|NCT01854528|147242005|SUPERIORITY_OR_OTHER||LS mean difference|7.55|||<|0.001|TWO_SIDED|95.0|5.11|9.98|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.||9.98|5.11|<0.001
74084713|NCT02327325|147722703|SUPERIORITY||Mean Difference (Final Values)|3.64||||0.097|TWO_SIDED|95.0|-0.69|7.96|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||7.96|-0.69|0.097
73848028|NCT01854528|147242006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|54.7|||<|0.001|TWO_SIDED|95.0|6.9|435.1|||Regression, Logistic|||P-value from logistic regression model including treatment arm, baseline log10 HCV RNA level, HCV subgenotype, and previous response to pegIFN/RBV treatment as predictors.||435.1|6.9|<0.001
73848029|NCT01957865|147242024|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Linear and Poisson regressions|||In an intention-to-treat analysis, percentage doses taken each month were compared by linear generalized estimating equations (GEEs); more than 48-h and more than 96-h lapses in dosingwere compared by Poisson GEE regression.||||<0.05
73848030|NCT01957865|147242025|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher's exact test|||HIV RNA suppression (\<100 copies/ml) was compared among study arms by Fisher's exact test.||||<0.05
73848031|NCT00811720|147242033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|0.75||0.002|TWO_SIDED|95.0|-3.81|-0.85|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-0.85|-3.81|0.002
73848032|NCT00811720|147242034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.96|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-16.81|-5.11|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-5.11|-16.81|<0.001
73848033|NCT00811720|147242035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.039|TWO_SIDED|95.0|0.5|0.98|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values imputed as non-response.||0.98|0.50|0.039
73848034|NCT00811720|147242036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.16|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.16|-0.57|<0.001
73848035|NCT00811720|147242037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.15|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.15|-0.53|<0.001
73848036|NCT00811720|147242038|SUPERIORITY_OR_OTHER||Ratio to placebo|0.88||||0.009|TWO_SIDED|95.0|0.8|0.97|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 211 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.97|0.80|0.009
73848037|NCT00811720|147242039|SUPERIORITY_OR_OTHER||Ratio to placebo|0.9||||0.011|TWO_SIDED|95.0|0.84|0.98|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 209 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||0.98|0.84|0.011
73848038|NCT02765399|147242051|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73848039|NCT02765399|147242051|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
73848040|NCT02765399|147242052|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
73848041|NCT02765399|147242052|OTHER|||||||0.612|||||||Wilcoxon (Mann-Whitney)|||||||0.612
73848042|NCT02765399|147242053|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73848043|NCT02765399|147242053|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
73848044|NCT02765399|147242054|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73848045|NCT02765399|147242054|OTHER|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||||||0.343
73848046|NCT02765399|147242055|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73848047|NCT02765399|147242055|OTHER|||||||0.865|||||||Wilcoxon (Mann-Whitney)|||||||0.865
73848048|NCT02765399|147242056|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||||||0.532
73848049|NCT02765399|147242056|OTHER|||||||0.735|||||||Wilcoxon (Mann-Whitney)|||||||0.735
73848050|NCT02765399|147242057|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
73848051|NCT02765399|147242057|OTHER|||||||0.753|||||||Wilcoxon (Mann-Whitney)|||||||0.753
73848052|NCT02765399|147242058|OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
73848053|NCT02765399|147242058|OTHER|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||0.499
73848054|NCT02765399|147242059|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73848055|NCT02765399|147242059|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
73900139|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|9.0|||||TWO_SIDED|95.0|4.9|13.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.6|4.9|
73900140|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|5.0|||||TWO_SIDED|95.0|1.2|9.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.7|1.2|
73900141|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|15.0|||||TWO_SIDED|95.0|7.5|22.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||22.6|7.5|
73848056|NCT02765399|147242060|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
73848057|NCT02765399|147242060|OTHER|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||||||0.578
73848058|NCT02765399|147242061|OTHER|||||||0.152|||||||Wilcoxon (Mann-Whitney)|||||||0.152
73848059|NCT02765399|147242061|OTHER|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
73900142|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-6.8|10.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.0|-6.8|
73900143|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-9.8|15.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.2|-9.8|
73960562|NCT03622593|147456698|OTHER||Difference in CMH Weighted Percentage|1.6|||||TWO_SIDED|95.0|-1.5|4.6||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.6|-1.5|
73960563|NCT03622593|147456702|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.3|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.3|
73960564|NCT03622593|147456702|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-2.0|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.0|
73848060|NCT02765399|147242062|OTHER|||||||0.173|||||||Wilcoxon (Mann-Whitney)|||||||0.173
73848061|NCT02765399|147242062|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
73848062|NCT02765399|147242063|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73900144|NCT02446743|147331785|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-7.8|14.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||14.7|-7.8|
73900145|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group ratio of GMTs|2.54|||||TWO_SIDED|95.0|2.07|3.12|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.12|2.07|
73900146|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|2.13|||||TWO_SIDED|95.0|1.66|2.72|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.72|1.66|
73900147|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|2.96|||||TWO_SIDED|95.0|2.15|4.07|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.07|2.15|
73960565|NCT03622593|147456702|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.7|2.6||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.6|-2.7|
73848063|NCT02765399|147242063|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
73848064|NCT02765399|147242064|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73848065|NCT02765399|147242064|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
73848066|NCT02765399|147242065|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73848067|NCT02765399|147242065|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
73848068|NCT02765399|147242066|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
74023297|NCT01478958|147599340|SUPERIORITY_OR_OTHER||||||>|0.05||||||Effect of MUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||>0.05
74023298|NCT01478958|147599340|SUPERIORITY_OR_OTHER||||||>|0.05||||||Effect of n-6 PUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||>0.05
73848069|NCT02765399|147242066|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
73848070|NCT02765399|147242067|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73848071|NCT02765399|147242067|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
73848072|NCT02765399|147242068|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73848073|NCT02765399|147242068|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
73848074|NCT02765399|147242069|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
73848075|NCT02765399|147242069|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
73848076|NCT02765399|147242070|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
73848077|NCT02765399|147242070|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
73848078|NCT02765399|147242071|OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||||||0.068
73848079|NCT02765399|147242071|OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
73848080|NCT00768261|147242072|OTHER|||||||0.095|TWO_SIDED|95.0|||||ANOVA|df= 3,92||||||0.095
73848081|NCT00768261|147242073|OTHER|||||||0.066|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.066
73848082|NCT00768261|147242073|OTHER|||||||0.009|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.009
73848083|NCT00768261|147242073|OTHER|||||||0.3|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.30
73848084|NCT00768261|147242073|OTHER|||||||0.0288|TWO_SIDED|95.0|||||Repeated Measures ANOVA|||RM-ANOVA on hippocampal volume slope||||0.0288
73848085|NCT02525679|147242090|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.5968|STANDARD_ERROR_OF_MEAN|0.1047|||TWO_SIDED|95.0|1.3784|1.8151|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for Cmax (log-transformed scale) was explored based on the linear regression model.||1.8151|1.3784|
73848086|NCT02525679|147242090|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0207|STANDARD_ERROR_OF_MEAN|0.0261|||TWO_SIDED|95.0|0.9668|1.0747|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for Cmax (log-transformed scale) was explored based on the linear regression model.||1.0747|0.9668|
73900148|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|16.0|||||TWO_SIDED|95.0|12.0|21.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||21|12|
73900149|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|20.0|||||TWO_SIDED|95.0|14.0|28.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||28|14|
74023299|NCT04373460|147599384|SUPERIORITY||Risk Difference (RD)|3.4||||0.005|TWO_SIDED|95.0|1.0|5.8|||Fisher Exact|||||5.8|1.0|0.005
74023300|NCT04373460|147599385|SUPERIORITY||Risk Difference (RD)|-0.05||||0.16|TWO_SIDED|95.0|-0.11|0.02|||Rate per person-years|||||0.02|-0.11|0.16
74023301|NCT04373460|147599386|SUPERIORITY||Incidence rate difference|0.18||||0.02|TWO_SIDED|95.0|0.03|0.32|||Rate per person-years|||||0.32|0.03|0.02
73848087|NCT02525679|147242092|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.7123|STANDARD_ERROR_OF_MEAN|0.2525|||TWO_SIDED|95.0|2.1856|3.2389|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for AUC(0-tz) (log-transformed scale) was explored based on the linear regression model.||3.2389|2.1856|
73848088|NCT02525679|147242092|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0003|STANDARD_ERROR_OF_MEAN|0.0253|||TWO_SIDED|95.0|0.9482|1.0525|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for AUC(0-tz) (log-transformed scale) was explored based on the linear regression model.||1.0525|0.9482|
74023302|NCT04373460|147599387|SUPERIORITY||Risk Difference (RD)|0.01||||0.32|TWO_SIDED|95.0|-0.01|0.02|||Rate per person-years|||||0.02|-0.01|0.32
74023303|NCT04373460|147599392|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||0.65
74023304|NCT04373460|147599396|SUPERIORITY||Risk Ratio (RR)|0.525|||||TWO_SIDED|95.0|0.192|1.425||||||||1.425|0.192|
74023305|NCT00642642|147599397|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||a priori threshold for statistical significance was 0.05|McNemar|Paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpoints"||||0.0109
74023306|NCT00642642|147599398|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||a priori threshold for statistical significance = 0.05|McNemar|paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpoints"||||<0.0001
74084714|NCT02327325|147722703|SUPERIORITY||Mean Difference (Final Values)|2.91||||0.196|TWO_SIDED|95.0|-1.55|7.39|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.||7.39|-1.55|0.196
73848089|NCT01822665|147242093|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.63|-0.59||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||-0.59|-1.63|<0.0001
73848090|NCT01822665|147242094|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.0095|TWO_SIDED|95.0|-1.23|-0.18|||t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||-0.18|-1.23|0.0095
73848091|NCT01822665|147242094|SUPERIORITY_OR_OTHER||LS mean difference|0.19||||0.4794|TWO_SIDED|95.0|-0.34|0.72||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||0.72|-0.34|0.4794
73848092|NCT01822665|147242094|SUPERIORITY_OR_OTHER||LS mean difference|0.4||||0.1429|TWO_SIDED|95.0|-0.14|0.95||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||0.95|-0.14|0.1429
73848093|NCT01822665|147242094|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||<|0.0001|TWO_SIDED|95.0|0.75|1.84||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||1.84|0.75|<0.0001
73848094|NCT01822665|147242094|SUPERIORITY_OR_OTHER||LS mean difference|0.89||||0.002|TWO_SIDED|95.0|0.34|1.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||1.45|0.34|0.0020
73848095|NCT01822665|147242095|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.6497|TWO_SIDED|95.0|-0.49|0.31||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.31|-0.49|0.6497
73848096|NCT01822665|147242095|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.7591|TWO_SIDED|95.0|-0.46|0.34||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.34|-0.46|0.7591
73848097|NCT01822665|147242095|SUPERIORITY_OR_OTHER||LS mean difference|0.17||||0.4126|TWO_SIDED|95.0|-0.24|0.57||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.57|-0.24|0.4126
73900150|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|14.0|||||TWO_SIDED|95.0|9.05|20.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||20|9.05|
74023307|NCT00332202|147599437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.541|TWO_SIDED|95.0|0.689|1.216|||Log Rank|||||1.216|0.689|0.541
74023308|NCT00332202|147599443|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 2||||0.606
74023309|NCT00332202|147599443|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 4||||0.971
74023310|NCT00332202|147599443|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 6||||0.580
74084715|NCT02327325|147722704|SUPERIORITY||Mean Difference (Final Values)|-4.1|||<|0.01|TWO_SIDED|95.0|-6.85|-1.34|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||-1.34|-6.85|<0.01
73900151|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|1.5|||||TWO_SIDED|95.0|1.26|1.78|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.78|1.26|
73900152|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|1.3|||||TWO_SIDED|95.0|1.11|1.51|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.51|1.11|
73900153|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|1.7|||||TWO_SIDED|95.0|1.27|2.28|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.28|1.27|
73900154|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|1.26|||||TWO_SIDED|95.0|0.94|1.68|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.68|0.94|
73900155|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|1.32|||||TWO_SIDED|95.0|0.85|2.05|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.05|0.85|
73900156|NCT02446743|147331786|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|1.2|||||TWO_SIDED|95.0|0.81|1.78|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.78|0.81|
73900157|NCT02446743|147331791|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|8.0|21.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||21.6|8.0|
73960566|NCT03622593|147456702|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.9|2.3||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.3|-2.9|
73960567|NCT03622593|147456702|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-2.0|4.7||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.7|-2.0|
73900158|NCT02446743|147331791|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|16.0|||||TWO_SIDED|95.0|10.8|23.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||23.1|10.8|
73900159|NCT02446743|147331791|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|11.0|20.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||20.1|11.0|
73900160|NCT02446743|147331791|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|54.0|||||TWO_SIDED|95.0|43.0|63.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||63.3|43.0|
73900161|NCT02446743|147331791|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|31.0|||||TWO_SIDED|95.0|22.0|40.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||40.1|22.0|
73900162|NCT02446743|147331791|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|41.0|||||TWO_SIDED|95.0|33.6|47.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||47.2|33.6|
73900163|NCT02446743|147331792|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|20.0|||||TWO_SIDED|95.0|15.0|25.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||25.4|15.0|
73960568|NCT03622593|147456702|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-2.1|4.4||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.4|-2.1|
73848098|NCT01822665|147242095|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.8903|TWO_SIDED|95.0|-0.39|0.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.45|-0.39|0.8903
73848099|NCT01822665|147242095|SUPERIORITY_OR_OTHER||LS mean difference|0.26||||0.2227|TWO_SIDED|95.0|-0.16|0.67||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.67|-0.16|0.2227
73848100|NCT01822665|147242095|SUPERIORITY_OR_OTHER||LS mean difference|0.23||||0.2855|TWO_SIDED|95.0|-0.2|0.65||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.65|-0.20|0.2855
73848101|NCT01822665|147242096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.19||||0.0084|TWO_SIDED|95.0|1.6|23.97||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||23.97|1.60|0.0084
73848102|NCT01822665|147242096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19||||0.0999|TWO_SIDED|95.0|0.8|12.74||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||12.74|0.80|0.0999
73848103|NCT01822665|147242096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.2845|TWO_SIDED|95.0|0.58|6.5|||Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||6.50|0.58|0.2845
73848104|NCT00959907|147242160|SUPERIORITY_OR_OTHER|||||||0.832||95.0|||||t-test, 2 sided|||||||0.832
73848105|NCT00959907|147242161|SUPERIORITY_OR_OTHER|||||||0.658||95.0|||||t-test, 2 sided|||||||0.658
73848106|NCT00959907|147242161|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||t-test, 2 sided|||||||0.739
73848107|NCT00959907|147242162|SUPERIORITY_OR_OTHER|||||||0.184||95.0|||||t-test, 2 sided|||||||0.184
73900164|NCT02446743|147331792|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|18.0|||||TWO_SIDED|95.0|10.7|27.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||27.0|10.7|
73960569|NCT03622593|147456706|OTHER||Difference in CMH Weighted Percentage|4.8|||||TWO_SIDED|95.0|-3.1|12.7||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||12.7|-3.1|
73848108|NCT03958331|147242163|SUPERIORITY||Mean Difference (Final Values)|10.62|STANDARD_ERROR_OF_MEAN|3.38||0.002|TWO_SIDED|95.0|4.0|17.25|||ANCOVA|Model controlled for baseline adherence, resistance to peer influence, dose, active seizures, COVID timing, COVID Impact (3 items), and sex|||We also conducted a longitudinal mixed effects model for adherence over time, estimating a groupXtime interaction with the same covariates listed above and allowing for a non-linear effect.|17.25|4|0.002
73848109|NCT04290624|147242169|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.4|-0.2|||ANCOVA|||||-0.20|-0.40|<0.0001
73848110|NCT04290624|147242170|SUPERIORITY||Mean Difference (Final Values)|-28.6|STANDARD_ERROR_OF_MEAN|4.73|<|0.0001|TWO_SIDED|95.0|-38.1|-19.1|||ANCOVA|||At Week 6||-19.1|-38.1|<0.0001
73848111|NCT04290624|147242170|SUPERIORITY||Mean Difference (Final Values)|-27.9|STANDARD_ERROR_OF_MEAN|5.08|<|0.0001|TWO_SIDED|95.0|-38.2|-17.7|||ANCOVA|||At Week 12||-17.7|-38.2|<0.0001
73900165|NCT02446743|147331792|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|15.6|28.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||28.8|15.6|
73848112|NCT04290624|147242171|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.52|-0.27|||ANCOVA|||At Week 6||-0.27|-0.52|<0.0001
73848113|NCT04290624|147242171|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.47|-0.25|||ANCOVA|||At Week 12||-0.25|-0.47|<0.0001
73848114|NCT04290624|147242172|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|-1.14|-0.56|||ANCOVA|||At Week 6||-0.56|-1.14|<0.0001
73848115|NCT04290624|147242172|SUPERIORITY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.139|<|0.0001|TWO_SIDED|95.0|-1.23|-0.67|||ANCOVA|||At Week 12||-0.67|-1.23|<0.0001
73848116|NCT04290624|147242173|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.151|<|0.0001|TWO_SIDED|95.0|-1.22|-0.61|||ANCOVA|||At Week 6||-0.61|-1.22|<0.0001
73848117|NCT04290624|147242173|SUPERIORITY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.36|-0.74|||ANCOVA|||At Week 12||-0.74|-1.36|<0.0001
73848118|NCT04290624|147242174|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.41|-0.23|||ANCOVA|||||-0.23|-0.41|<0.0001
73848119|NCT04290624|147242175|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0039|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||At Week 6||-0.2|-0.9|0.0039
73848120|NCT04290624|147242175|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.1|-0.5|||ANCOVA|||At Week 12||-0.5|-1.1|<0.0001
73848121|NCT04290624|147242176|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0367|TWO_SIDED|95.0|-0.21|-0.01|||ANCOVA|||At Week 6||-0.01|-0.21|0.0367
73848122|NCT04290624|147242176|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.033||0.0725|TWO_SIDED|95.0|-0.14|-0.01|||Van-Elteren test|||At Week 12||-0.01|-0.14|0.0725
73848123|NCT04290624|147242177|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.075||0.0006|TWO_SIDED|95.0|-0.43|-0.13|||ANCOVA|||At Week 6||-0.13|-0.43|0.0006
73848124|NCT04290624|147242177|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.073||0.0009|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||At Week 12||-0.11|-0.41|0.0009
73848125|NCT04290624|147242178|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.117||0.002|TWO_SIDED|95.0|-0.62|-0.15|||ANCOVA|||At Week 6||-0.15|-0.62|0.0020
73848126|NCT04290624|147242178|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.52|-0.16|||ANCOVA|||At Week 12||-0.16|-0.52|0.0005
73848127|NCT04422431|147242179|OTHER|||||||0.1002|||||||t-test, 2 sided|||||||0.1002
73848128|NCT00896012|147242196|OTHER|||||||0.222||||||Significance was considered to be P \< .05|t-test, 2 sided|||Statistical analysis was performed by analysis of variance and Student t test for estimated glomerular filtration rate (eGFR) at 12 months. Chi-square analysis was used for demographics data.||||0.222
73848129|NCT02735421|147242198|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73848130|NCT03247829|147242211|OTHER|||||||0.001|||||||t-test, 2 sided|Comparative p-values were calculated by two-sided t-tests (paired analysis).||||||0.001
73848131|NCT03247829|147242212|OTHER|||||||0.0931|||||||t-test, 2 sided|||||||0.0931
73848132|NCT01783444|147242220|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|0.74|||||TWO_SIDED|90.0|0.57|0.97||||||||0.97|0.57|
73848133|NCT01783444|147242221|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.26|||||TWO_SIDED|90.0|0.96|1.66||||||||1.66|0.96|
73848134|NCT01783444|147242222|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.27|||||TWO_SIDED|90.0|0.95|1.7||||||||1.70|0.95|
73848135|NCT01783444|147242222|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.33|||||TWO_SIDED|90.0|0.99|1.79||||||||1.79|0.99|
73848136|NCT01783444|147242225|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.09|||||TWO_SIDED|90.0|0.72|1.66||||||||1.66|0.72|
73848137|NCT01783444|147242225|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.18|||||TWO_SIDED|90.0|0.78|1.77||||||||1.77|0.78|
73848138|NCT01783444|147242226|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|0.64|||||TWO_SIDED|90.0|0.46|0.88||||||||0.88|0.46|
73848139|NCT01783444|147242226|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.33|||||TWO_SIDED|90.0|0.93|1.91||||||||1.91|0.93|
73848140|NCT01783444|147242227|OTHER||Mean Difference (Net)|4.3|||||TWO_SIDED|90.0|-3.3|11.9||||||Side-effects||11.9|-3.3|
73848141|NCT01783444|147242227|OTHER||Mean Difference (Net)|-2.2|||||TWO_SIDED|90.0|-9.9|5.5||||||Side-effects||5.5|-9.9|
73848142|NCT01783444|147242227|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-10.4|3.8||||||Effectiveness||3.8|-10.4|
73848143|NCT01783444|147242227|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-9.7|3.0||||||Effectiveness||3.0|-9.7|
73848144|NCT01783444|147242227|OTHER||Mean Difference (Net)|-1.6|||||TWO_SIDED|90.0|-5.8|2.5||||||Convenience||2.5|-5.8|
73848145|NCT01783444|147242227|OTHER||Mean Difference (Net)|-1.1|||||TWO_SIDED|90.0|-5.5|3.3||||||Convenience||3.3|-5.5|
73848146|NCT01783444|147242227|OTHER||Mean Difference (Net)|-2.7|||||TWO_SIDED|90.0|-8.3|2.9||||||Global Satisfaction||2.9|-8.3|
73848147|NCT01783444|147242227|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-8.4|1.9||||||Global Satisfaction||1.9|-8.4|
73848148|NCT01334554|147242252|SUPERIORITY_OR_OTHER||Beta coefficient (linear regression)|0.12||||0.55|TWO_SIDED|95.0|-0.33|0.58||p- value was unadjusted. Primary outcome underwent logarithmic transformation|Regression, Linear|||H0= 4-week treatment with sildenafil citrate does not improve insulin sensitivity in obese African American women.||0.58|-0.33|0.55
73848149|NCT01334554|147242253|SUPERIORITY_OR_OTHER||Beta coefficient|0.46||||0.649|TWO_SIDED|95.0|-1.58|2.49||Adjusted for baseline values only|Regression, Linear|||||2.49|-1.58|0.649
73848150|NCT02393859|147242254|SUPERIORITY||Normal score|-11.54|||<|0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
73848151|NCT02393859|147242254|SUPERIORITY||Normal score|-11.16||||0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||0.001
73848152|NCT02393859|147242254|SUPERIORITY||Stratified hazard ratio (HR)|0.36|||||TWO_SIDED|95.0|0.19|0.66|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.66|0.19|
73848153|NCT02393859|147242254|SUPERIORITY||Unstratified HR|0.39|||||TWO_SIDED|95.0|0.22|0.7|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.70|0.22|
73848154|NCT02393859|147242254|SUPERIORITY||Stratified HR w/time-dependent covariate|0.36|||||TWO_SIDED|95.0|0.2|0.64|||||Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)|||0.64|0.20|
73848155|NCT02393859|147242255|SUPERIORITY||Normal score|-13.9|||<|0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
73848156|NCT02393859|147242255|SUPERIORITY||Normal score|-13.61|||<|0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for Blinatumomab relative to HC3 and therefore a longer event free survival time.|||||< 0.001
74023311|NCT00332202|147599443|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 12||||0.265
74023312|NCT00332202|147599443|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 18||||0.460
74084716|NCT02327325|147722704|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.17|TWO_SIDED|95.0|-4.85|0.86|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.||0.86|-4.85|0.17
73848157|NCT02393859|147242255|SUPERIORITY||Stratified HR|0.35|||||TWO_SIDED|95.0|0.2|0.61|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.61|0.20|
73848158|NCT02393859|147242255|SUPERIORITY||Unstratified HR|0.38|||||TWO_SIDED|95.0|0.22|0.65|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.65|0.22|
73848159|NCT02393859|147242255|SUPERIORITY||Stratified HR w/time-dependent covariate|0.34|||||TWO_SIDED|95.0|0.2|0.59|||||Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)|||0.59|0.20|
73848160|NCT02393859|147242256|SUPERIORITY||Normal score|-10.14||||0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||0.001
73848161|NCT02393859|147242256|SUPERIORITY||Normal score|-10.32|||<|0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
73848162|NCT02393859|147242256|SUPERIORITY||Stratified HR|0.33|||||TWO_SIDED|95.0|0.16|0.66|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)|||0.66|0.16|
73848163|NCT02393859|147242256|SUPERIORITY||Unstratified HR|0.32|||||TWO_SIDED|95.0|0.16|0.65|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)|||0.65|0.16|
73848164|NCT02393859|147242257|SUPERIORITY||||||<|0.001||||||Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Cochran-Mantel-Haenszel|||MRD response by PCR||||< 0.001
73848165|NCT02393859|147242257|SUPERIORITY||||||<|0.001||||||Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10-3 vs M1 with MRD level ≥ 10-3 vs M2).|Cochran-Mantel-Haenszel|||MRD response by flow cytometry||||< 0.001
73848166|NCT02393859|147242258|SUPERIORITY||Hazard Ratio (HR)|0.29|||||TWO_SIDED|95.0|0.16|0.52|||||The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.)|||0.52|0.16|
73848167|NCT02393859|147242258|SUPERIORITY||Stratified hazard ratio (HR)|0.27|||||TWO_SIDED|95.0|0.15|0.48|||||The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.) Stratification factors are age and marrow/MRD status.|||0.48|0.15|
73848168|NCT00954447|147242266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.74|-0.55|||ANCOVA||Linagliptin 5mg - Placebo|||-0.55|-0.74|<0.0001
73848169|NCT00954447|147242267|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.935|||<|0.0001||95.0|1.949|4.419|||Regression, Logistic|Logistic regression of HbA1c \< 7.0 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c \>= 7.0 percent (NCF); there are 593 available values for Placebo and 595 for Linagliptin 5mg||4.419|1.949|<0.0001
73848170|NCT00954447|147242269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|-0.51|-0.39|||ANCOVA||Linagliptin 5mg - Placebo|||-0.39|-0.51|<0.0001
73848171|NCT00954447|147242270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.69|-0.52|||ANCOVA||Linagliptin 5mg - Placebo|||-0.52|-0.69|<0.0001
73848172|NCT00954447|147242271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.76|-0.57|||ANCOVA||Linagliptin 5mg - Placebo|||-0.57|-0.76|<0.0001
73848173|NCT00954447|147242272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.67|-0.47|||ANCOVA||Linagliptin 5mg - Placebo|||-0.47|-0.67|<0.0001
73848174|NCT00954447|147242273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.65|-0.45|||ANCOVA||Linagliptin 5mg - Placebo|||-0.45|-0.65|<0.0001
73848175|NCT00954447|147242274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.64|-0.43|||ANCOVA||Linagliptin 5mg - Placebo|||-0.43|-0.64|<0.0001
73848176|NCT00954447|147242275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001||95.0|-16.49|-6.71|||ANCOVA||Linagliptin 5mg - Placebo|||-6.71|-16.49|<0.0001
73848177|NCT00954447|147242278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.53||0.0029||95.0|-2.61|-0.54|||ANCOVA||Linagliptin 5mg - Placebo|||-0.54|-2.61|0.0029
74023313|NCT00332202|147599443|SUPERIORITY_OR_OTHER|||||||0.441|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 24||||0.441
74023314|NCT00332202|147599443|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 36||||0.357
74023315|NCT00332202|147599444|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 6||||0.267
74023316|NCT00332202|147599444|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 24||||0.807
74023317|NCT00332202|147599444|SUPERIORITY_OR_OTHER|||||||0.864|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 33||||0.864
74023318|NCT00332202|147599445|SUPERIORITY||Hazard Ratio (HR)|0.768||||0.4|TWO_SIDED|95.0|0.415|1.42|||Regression, Cox|||||1.420|0.415|0.400
74023319|NCT00332202|147599445|SUPERIORITY||Hazard Ratio (HR)|1.309||||0.539|TWO_SIDED|95.0|0.557|3.08|||Regression, Cox|||||3.080|0.557|0.539
73960570|NCT03622593|147456706|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-8.8|6.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||6.2|-8.8|
73960571|NCT03622593|147456706|OTHER||Difference in CMH Weighted Percentage|2.6|||||TWO_SIDED|95.0|-6.5|11.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||11.6|-6.5|
73960572|NCT03622593|147456706|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-10.0|7.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||7.4|-10.0|
73960573|NCT03622593|147456709|OTHER||Difference in CMH Weighted Percentage|4.7|||||TWO_SIDED|95.0|-2.4|11.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||11.8|-2.4|
73960574|NCT03622593|147456709|OTHER||Difference in CMH Weighted Percentage|2.8|||||TWO_SIDED|95.0|-4.1|9.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.8|-4.1|
73960575|NCT03622593|147456709|OTHER||Difference in CMH Weighted Percentage|1.5|||||TWO_SIDED|95.0|-6.5|9.4||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||9.4|-6.5|
73960576|NCT03622593|147456709|OTHER||Difference in CMH Weighted Percentage|1.7|||||TWO_SIDED|95.0|-6.0|9.3||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||9.3|-6.0|
73960577|NCT03622593|147456712|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-1.4|1.5||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.5|-1.4|
73960578|NCT03622593|147456712|OTHER||Difference in CMH Weighted Percentage|-0.7|||||TWO_SIDED|95.0|-1.6|0.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.2|-1.6|
73960579|NCT03622593|147456712|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.1|2.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.1|-1.1|
73960580|NCT03622593|147456712|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-1.4|0.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.4|-1.4|
73960581|NCT03622593|147456721|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.0|1.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.8|-1.0|
73960582|NCT03622593|147456721|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.0|2.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.0|
73960583|NCT03622593|147456721|OTHER||Difference in CMH Weighted Percentage|0.6|||||TWO_SIDED|95.0|-0.6|1.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||1.8|-0.6|
73960584|NCT03622593|147456721|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-0.4|2.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.8|-0.4|
73960585|NCT03622593|147456722|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
73960586|NCT03622593|147456722|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
73960587|NCT03622593|147456722|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
73960588|NCT03622593|147456722|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
73960589|NCT03622593|147456729|OTHER||Adjusted mean difference|-25.7|STANDARD_ERROR_OF_MEAN|5.95|||TWO_SIDED|95.0|-37.4|-14.0||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-14.0|-37.4|
73960590|NCT03622593|147456729|OTHER||Adjusted mean difference|-17.6|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|95.0|-29.2|-6.0||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-6.0|-29.2|
73960591|NCT03622593|147456729|OTHER||Adjusted mean difference|-20.0|STANDARD_ERROR_OF_MEAN|6.59|||TWO_SIDED|95.0|-32.9|-7.0||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-7.0|-32.9|
73960592|NCT03622593|147456729|OTHER||Adjusted mean difference|-14.3|STANDARD_ERROR_OF_MEAN|6.51|||TWO_SIDED|95.0|-27.1|-1.5||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-1.5|-27.1|
73960593|NCT03622593|147456732|OTHER||Difference in CMH Weighted Percentage|12.3|||||TWO_SIDED|95.0|5.7|18.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||18.9|5.7|
73960594|NCT03622593|147456732|OTHER||Difference in CMH Weighted Percentage|8.2|||||TWO_SIDED|95.0|1.5|14.9||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||14.9|1.5|
73960595|NCT03622593|147456732|OTHER||Difference in CMH Weighted Percentage|9.0|||||TWO_SIDED|95.0|1.6|16.3||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||16.3|1.6|
73848178|NCT00954447|147242281|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.327|||<|0.0001||95.0|2.221|8.43|||Regression, Logistic|Logistic regression of HbA1c \< 6.5 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c \>= 6.5 percent (NCF); there are 615 available values for Placebo and 616 for Linagliptin 5mg||8.430|2.221|<0.0001
73848179|NCT00887159|147242335|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.45|TWO_SIDED|95.0|0.65|1.47||P-value is one-sided.|Regression, Cox||The hazard ratio was derived comparing Arm B to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.||1.47|0.65|0.45
73900166|NCT02446743|147331792|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|12.0|||||TWO_SIDED|95.0|8.0|16.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.8|8.0|
73900167|NCT02446743|147331792|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|20.0|||||TWO_SIDED|95.0|12.8|28.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.6|12.8|
73900168|NCT02446743|147331792|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|6.0|||||TWO_SIDED|95.0|1.5|12.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.2|1.5|
73900169|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|27.0|||||TWO_SIDED|95.0|21.9|33.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||33.3|21.9|
73900170|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|31.0|||||TWO_SIDED|95.0|21.8|40.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||40.3|21.8|
73960596|NCT03622593|147456732|OTHER||Difference in CMH Weighted Percentage|6.2|||||TWO_SIDED|95.0|-1.2|13.6||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||13.6|-1.2|
73960597|NCT03762668|147456744|NON_INFERIORITY|Noninferiority in VA was declared if the Upper Confidence Limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.005|||ONE_SIDED|95.0||0.01|||mixed effects repeated measures model||test minus control|||0.01||
73960598|NCT00465816|147456748|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenA GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.8|1.22|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenA GMT of the Nimenrix + Twinrix group compared to Nimenrix one, two-sided 95% confidence interval (CI) from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.22|0.8|
73900171|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|26.0|||||TWO_SIDED|95.0|19.2|33.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||33.1|19.2|
73900172|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|19.0|||||TWO_SIDED|95.0|14.3|24.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||24.3|14.3|
73900173|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.1|27.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||27.5|12.1|
73900174|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|19.0|||||TWO_SIDED|95.0|13.3|26.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||26.4|13.3|
73900175|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|43.0|||||TWO_SIDED|95.0|35.2|49.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||49.9|35.2|
73848180|NCT00887159|147242335|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.48|TWO_SIDED|95.0|0.66|1.48||P-value is one-sided.|Regression, Cox||Hazard ratio was derived comparing Arm C to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.||1.48|0.66|0.48
73848181|NCT00887159|147242338|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.69||||0.01|TWO_SIDED|95.0|1.13|2.52|||Regression, Cox||Hazard ratio was derived comparing the high CTCs group to the low CTCs group.|||2.52|1.13|0.01
73848182|NCT03181971|147242339|SUPERIORITY||Odds Ratio (OR)|0.7||||0.68|TWO_SIDED|95.0|0.2|2.9|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||2.9|0.2|0.68
73960599|NCT00465816|147456748|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenC GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.68|1.21|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenC GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.21|0.68|
73848183|NCT03181971|147242339|SUPERIORITY||Odds Ratio (OR)|0.1||||0.017|TWO_SIDED|95.0|0.03|0.7|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months||0.7|0.03|0.017
73848184|NCT03181971|147242340|SUPERIORITY||Odds Ratio (OR)|0.4||||0.24|TWO_SIDED|95.0|0.07|2.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||2.0|0.07|.24
73848185|NCT03181971|147242340|SUPERIORITY||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.1|7.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||7.0|0.1|.98
73848186|NCT03181971|147242341|SUPERIORITY||Adjusted mean difference|0.2||||0.57|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||1.0|-0.6|0.57
73848187|NCT03181971|147242341|SUPERIORITY||Adjusted mean difference|-0.5||||0.4|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.6|-1.5|.40
73848188|NCT03181971|147242342|SUPERIORITY||Adjusted mean difference|0.04||||0.46|TWO_SIDED|95.0|-0.06|0.1|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||0.1|-0.06|.46
73848189|NCT03181971|147242342|SUPERIORITY||Adjusted mean difference|-0.02||||0.8|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.1|-0.2|.80
73848190|NCT03181971|147242343|SUPERIORITY||Adjusted mean difference|0.001||||0.93|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||0.03|-0.03|.93
73848191|NCT03181971|147242343|SUPERIORITY||Adjusted mean difference|-0.02||||0.36|TWO_SIDED|95.0|-0.06|0.02|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.02|-0.06|.36
73848192|NCT03181971|147242344|SUPERIORITY||Percent difference in change|1.4||||0.7|TWO_SIDED|95.0|-5.3|8.5||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change in total kcal intake from baseline to 7 months.||8.5|-5.3|0.70
73848193|NCT03181971|147242344|SUPERIORITY||Percent difference in change|3.7||||0.35|TWO_SIDED|95.0|-3.9|12.0||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change in intake of food kcal from baseline to 7 months.||12.0|-3.9|.35
73848194|NCT03181971|147242344|SUPERIORITY||Percent difference in change|-10.6||||0.35|TWO_SIDED|95.0|-29.2|8.8|||Mixed Models Analysis|||Analysis of between group change in intake of beverage kcal from baseline to 7 months.||8.8|-29.2|.35
73848195|NCT03181971|147242344|SUPERIORITY||Percent difference in change|-17.5||||0.18|TWO_SIDED|95.0|-37.8|9.6|||Mixed Models Analysis|||Analysis of between group change in SSB kcal from baseline to 7 months.||9.6|-37.8|.18
73848196|NCT03181971|147242345|SUPERIORITY||Percent difference in change|9.1||||0.59|TWO_SIDED|95.0|-20.6|49.9||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||49.9|-20.6|.59
73848197|NCT03181971|147242346|SUPERIORITY||Percent difference in change|23.2|||<|0.001|TWO_SIDED|95.0|13.1|34.2|||Mixed Models Analysis|||Analysis of between group change in water intake from baseline to 7 months.||34.2|13.1|<.001
73848198|NCT03181971|147242346|SUPERIORITY||Percent difference in change|14.7||||0.004|TWO_SIDED|95.0|4.5|25.9|||Mixed Models Analysis|||Analysis of between group change in water intake from baseline to 15 months.||25.9|4.5|.004
73848199|NCT03181971|147242346|SUPERIORITY||Percent difference in change|-8.0||||0.063|TWO_SIDED|95.0|-15.7|0.4|||Mixed Models Analysis|||Analysis of between group change in SSB intake from baseline to 7 months.||0.4|-15.7|0.063
73848200|NCT03181971|147242346|SUPERIORITY||Percent difference in change|-2.8||||0.56|TWO_SIDED|95.0|-11.7|6.9|||Mixed Models Analysis|||Analysis of between group change in SSB intake from baseline to 15 months.||6.9|-11.7|.56
73848201|NCT03181971|147242346|SUPERIORITY||Percent difference in change|1.2||||0.68|TWO_SIDED|95.0|-4.3|7.0|||Mixed Models Analysis|||Analysis of between group change in juice intake from baseline to 7 months.||7|-4.3|.68
73848202|NCT03181971|147242346|SUPERIORITY||Percent difference in change|-1.4||||0.66|TWO_SIDED|95.0|-7.4|5.0|||Mixed Models Analysis|||Analysis of between group change in juice intake from baseline to 15 months.||5|-7.4|.66
73960600|NCT00465816|147456748|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenW-135 GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.02|||||TWO_SIDED|95.0|0.87|1.19|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenW-135 GMT of the Nimenrix+Twinrixg roup compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.19|0.87|
74023320|NCT00332202|147599446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.775||||0.084|TWO_SIDED|95.0|0.947|3.329|||Regression, Cox|||||3.329|0.947|0.084
73848203|NCT03181971|147242346|SUPERIORITY||Percent difference in change|-4.0||||0.079|TWO_SIDED|95.0|-8.3|0.5|||Mixed Models Analysis|||Analysis of between group change in flavored milk intake from baseline to 7 months.||0.5|-8.3|0.079
73848204|NCT03181971|147242346|SUPERIORITY||Percent difference in change|-3.0||||0.26|TWO_SIDED|95.0|-8.0|2.3|||Mixed Models Analysis|||Analysis of between group change in flavored milk intake from baseline to 15 months.||2.3|-8.0|.26
73848205|NCT03181971|147242346|SUPERIORITY||Percent difference in change|4.4||||0.2|TWO_SIDED|95.0|-2.2|11.5|||Mixed Models Analysis|||Analysis of between group change in plain milk intake from baseline to 7 months.||11.5|-2.2|.20
73848206|NCT03181971|147242346|SUPERIORITY||Percent difference in change|2.3||||0.51|TWO_SIDED|95.0|-4.4|9.6|||Mixed Models Analysis|||Analysis of between group change in plain milk intake from baseline to 15 months.||9.6|-4.4|.51
73848207|NCT03181971|147242347|SUPERIORITY||Percent difference in change|31.3|||<|0.001|TWO_SIDED|95.0|21.2|42.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at lunch from baseline to 7 months.||42.2|21.2|<.001
73848208|NCT03181971|147242347|SUPERIORITY||Percent difference in change|4.9||||0.22|TWO_SIDED|95.0|-3.0|13.5|||Mixed Models Analysis|||Analysis of between group change in water intake from water source during lunch from baseline to 15 months.||13.5|-3.0|.22
73960601|NCT00465816|147456748|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenY GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.01|||||TWO_SIDED|95.0|0.85|1.19|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenY GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.19|0.85|
73960602|NCT00465816|147456749|NON_INFERIORITY|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|0.0|||||TWO_SIDED|95.0|-1.19|3.9||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroconversion rates for hepatitis A (Nimenrix+Twinrix group minus Twinrix group) was computed.||3.9|-1.19|
73960603|NCT00465816|147456750|NON_INFERIORITY|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|-0.91|||||TWO_SIDED|95.0|-2.64|2.92||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to the Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroprotection rates for hepatitis B (Nimenrix+Twinrix group minus Twinrix group) was computed.||2.92|-2.64|
73960604|NCT00004124|147456773|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7|TWO_SIDED|95.0|0.79|1.43|||Regression, Cox|||||1.43|0.79|0.70
73960605|NCT00004124|147456774|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.8|1.27|||Regression, Cox|||||1.27|0.80|0.94
73960606|NCT00186186|147456798|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
73960607|NCT00186186|147456799|SUPERIORITY_OR_OTHER||Percentage|54.0|||||TWO_SIDED|||||||||||||
73960608|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.82|||||TWO_SIDED|95.0|1.27|2.61|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||2.61|1.27|
73960609|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.57|||||TWO_SIDED|95.0|1.79|3.7|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||3.70|1.79|
73960610|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.7|||||TWO_SIDED|95.0|1.88|3.88|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||3.88|1.88|
73960611|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.79|||||TWO_SIDED|95.0|1.29|2.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.50|1.29|
73960612|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.19|||||TWO_SIDED|95.0|1.57|3.05|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||3.05|1.57|
73960613|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.52|||||TWO_SIDED|95.0|1.81|3.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||3.50|1.81|
73960614|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.68|||||TWO_SIDED|95.0|0.54|0.87|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.87|0.54|
73960615|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.12|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||1.12|0.69|
73848209|NCT03181971|147242347|SUPERIORITY||Percent difference in change|17.0||||0.02|TWO_SIDED|95.0|2.6|33.3|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at recess from baseline to 7 months.||33.3|2.6|.02
73848210|NCT03181971|147242347|SUPERIORITY||Percent difference in change|4.7||||0.48|TWO_SIDED|95.0|-8.0|19.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at recess from baseline to 15 months.||19.2|-8.0|.48
73848211|NCT03181971|147242347|SUPERIORITY||Percent difference in change|34.6||||0.14|TWO_SIDED|95.0|-9.4|99.8|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at PE from baseline to 7 months.||99.8|-9.4|.14
73848212|NCT03181971|147242347|SUPERIORITY||Percent difference in change|32.1||||0.16|TWO_SIDED|95.0|-11.0|96.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at PE from baseline to 15 months.||96.2|-11.0|.16
73960616|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.06|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||1.06|0.66|
73960617|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.11|||||TWO_SIDED|95.0|0.86|1.44|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.44|0.86|
73960618|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.19|||||TWO_SIDED|95.0|0.93|1.54|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.54|0.93|
73960619|NCT04956575|147456864|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.55|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.55|0.93|
74084717|NCT02327325|147722705|SUPERIORITY||Median Difference (Final Values)|0.16||||0.95|TWO_SIDED|95.0|-4.86|5.19|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||5.19|-4.86|0.95
74084718|NCT02327325|147722705|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.97|TWO_SIDED|95.0|-7.07|1.07|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.||1.07|-7.07|0.97
73848213|NCT02163577|147242367|SUPERIORITY||||||<|0.0001||||||Per generalized estimating equations (GEE) model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
73848214|NCT02163577|147242367|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
73848215|NCT02163577|147242367|SUPERIORITY||Difference in LS Means|-0.33|||||TWO_SIDED|95.0|-0.63|-0.04||||||Difference in change to Week 40||-0.04|-0.63|
73848216|NCT02163577|147242367|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848217|NCT02163577|147242367|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848218|NCT02163577|147242367|SUPERIORITY||Difference in LS Means|-0.16|||||TWO_SIDED|95.0|-0.45|0.13||||||Difference in change to Week 64||0.13|-0.45|
73848219|NCT02163577|147242367|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848220|NCT02163577|147242367|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848221|NCT02163577|147242368|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
73848222|NCT02163577|147242368|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
73848223|NCT02163577|147242368|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
73848224|NCT02163577|147242368|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
73848225|NCT02163577|147242368|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
73848226|NCT02163577|147242368|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
73960620|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.9|||||TWO_SIDED|95.0|0.57|1.44|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||1.44|0.57|
73960621|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.25|||||TWO_SIDED|95.0|0.78|2.0|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||2.00|0.78|
73960622|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.86|||||TWO_SIDED|95.0|1.16|2.99|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against H1N1 at Day 29.||2.99|1.16|
73960623|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.41|||||TWO_SIDED|95.0|0.91|2.21|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.21|0.91|
73848227|NCT02163577|147242369|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
73848228|NCT02163577|147242369|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
73848229|NCT02163577|147242369|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
74023321|NCT00332202|147599446|SUPERIORITY||Hazard Ratio (HR)|1.286||||0.585|TWO_SIDED|95.0|0.527|3.137|||Regression, Cox|||||3.137|0.527|0.585
73848230|NCT02163577|147242369|SUPERIORITY|||||||0.0024|||||||one sample t test|||Week 64||||0.0024
73848231|NCT02163577|147242369|SUPERIORITY|||||||0.0018|||||||one sample t test|||Week 160||||0.0018
73848232|NCT02163577|147242369|SUPERIORITY|||||||0.0002|||||||one sample t test|||Week 160||||0.0002
73848233|NCT02163577|147242370|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
73848234|NCT02163577|147242370|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
73848235|NCT02163577|147242370|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
73848236|NCT02163577|147242370|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
73848237|NCT02163577|147242370|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
73848238|NCT02163577|147242370|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
73848239|NCT02163577|147242371|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
73848240|NCT02163577|147242371|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
73848241|NCT02163577|147242371|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848242|NCT02163577|147242371|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848243|NCT02163577|147242371|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848244|NCT02163577|147242371|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848245|NCT02163577|147242372|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
73848246|NCT02163577|147242372|SUPERIORITY|||||||0.0015||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||0.0015
73848247|NCT02163577|147242372|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848248|NCT02163577|147242372|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848249|NCT02163577|147242372|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848250|NCT02163577|147242372|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848251|NCT02163577|147242373|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
73848252|NCT02163577|147242373|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
73848253|NCT02163577|147242373|SUPERIORITY||Difference in LS Means|0.21|||||TWO_SIDED|95.0|-0.12|0.54||||||Difference in change to Week 40||0.54|-0.12|
73848254|NCT02163577|147242373|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848255|NCT02163577|147242373|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848256|NCT02163577|147242373|SUPERIORITY||Difference in LS Means|-0.02|||||TWO_SIDED|95.0|-0.34|0.29||||||Difference in change to Week 64||0.29|-0.34|
73848257|NCT02163577|147242373|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848258|NCT02163577|147242373|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848259|NCT02163577|147242374|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
73848260|NCT02163577|147242374|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
74023322|NCT02863198|147599452|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
74023323|NCT02863198|147599453|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
74023324|NCT02863198|147599454|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared|||||||<0.05
74023325|NCT02863198|147599455|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
73900176|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|58.0|||||TWO_SIDED|95.0|46.6|67.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||67.3|46.6|
73900177|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|33.0|||||TWO_SIDED|95.0|23.0|42.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||42.5|23.0|
73900178|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|13.0|||||TWO_SIDED|95.0|8.8|18.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||18.3|8.8|
73900179|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|20.0|||||TWO_SIDED|95.0|12.6|29.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||29.0|12.6|
73960624|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.89|||||TWO_SIDED|95.0|1.21|2.97|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.97|1.21|
73960625|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.64|||||TWO_SIDED|95.0|1.68|4.14|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||4.14|1.68|
73960626|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.36|||||TWO_SIDED|95.0|0.26|0.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.50|0.26|
73960627|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.46|||||TWO_SIDED|95.0|0.33|0.64|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.64|0.33|
73960628|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.54|||||TWO_SIDED|95.0|0.38|0.76|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.76|0.38|
73960629|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.62|||||TWO_SIDED|95.0|0.43|0.9|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||0.90|0.43|
73960630|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.92|||||TWO_SIDED|95.0|0.63|1.35|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.35|0.63|
73960631|NCT04956575|147456865|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.75|||||TWO_SIDED|95.0|0.51|1.09|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.09|0.51|
73960632|NCT04956575|147456868|OTHER||Percent difference|12.61|||||TWO_SIDED|95.0|-2.0|27.93|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||27.93|-2.00|
73960633|NCT04956575|147456868|OTHER||Percent difference|25.17|||||TWO_SIDED|95.0|11.18|39.89|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||39.89|11.18|
73960634|NCT04956575|147456868|OTHER||Percent Difference|26.2|||||TWO_SIDED|95.0|12.33|40.84|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||40.84|12.33|
73960635|NCT04956575|147456868|OTHER||Percent Difference|25.59|||||TWO_SIDED|95.0|9.82|40.13|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||40.13|9.82|
73960636|NCT04956575|147456868|OTHER||Percent Difference|31.35|||||TWO_SIDED|95.0|15.66|45.73|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||45.73|15.66|
73900180|NCT02446743|147331793|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|8.0|||||TWO_SIDED|95.0|2.7|14.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||14.7|2.7|
73848261|NCT02163577|147242374|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848262|NCT02163577|147242374|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848263|NCT02163577|147242374|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848264|NCT02163577|147242374|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848265|NCT02163577|147242375|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
73848266|NCT02163577|147242375|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
73848267|NCT02163577|147242375|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848268|NCT02163577|147242375|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848269|NCT02163577|147242375|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848270|NCT02163577|147242375|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848271|NCT02163577|147242376|SUPERIORITY|||||||0.0088|||||||one sample t-test|||Week 0 to Week 40||||0.0088
73848272|NCT02163577|147242376|SUPERIORITY|||||||0.465|||||||one sample t-test|||Week 0 to Week 40||||0.4650
73848273|NCT02163577|147242376|SUPERIORITY|||||||0.016|||||||one sample t test|||Week 0 to Week 64||||0.0160
73848274|NCT02163577|147242376|SUPERIORITY|||||||0.4114|||||||one sample t test|||Week 0 to Week 64||||0.4114
73900181|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|40.0|||||TWO_SIDED|95.0|33.9|46.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||46.3|33.9|
74084719|NCT03653026|147722712|SUPERIORITY||Adjusted Response Rate Difference|29.0|||<|0.001|TWO_SIDED|95.0|23.2|34.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||34.7|23.2|<0.001
73848275|NCT02163577|147242376|SUPERIORITY|||||||0.5335|||||||one sample t test|||Week 64 to Week 112||||0.5335
73848276|NCT02163577|147242376|SUPERIORITY|||||||0.8606|||||||one sample t test|||Week 64 to Week 112||||0.8606
73848277|NCT02163577|147242376|SUPERIORITY|||||||0.1627|||||||one sample t test|||Week 112 to Week 160||||0.1627
73848278|NCT02163577|147242376|SUPERIORITY|||||||0.4096|||||||one sample t test|||Week 112 to Week 160||||0.4096
73848279|NCT02163577|147242377|SUPERIORITY||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
73848280|NCT02163577|147242377|SUPERIORITY|||||||0.0569||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40||||0.0569
73848281|NCT02163577|147242377|SUPERIORITY|||||||0.0002||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64||||0.0002
73848282|NCT02163577|147242377|SUPERIORITY|||||||0.0456||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64||||0.0456
73848283|NCT02163577|147242377|SUPERIORITY||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848284|NCT02163577|147242377|SUPERIORITY|||||||0.0343||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160||||0.0343
73848285|NCT02163577|147242382|SUPERIORITY|||||||0.0771||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0771
73960637|NCT04956575|147456868|OTHER||Percent Difference|38.34|||||TWO_SIDED|95.0|22.98|52.3|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||52.30|22.98|
73960638|NCT04956575|147456868|OTHER||Percent Difference|-9.78|||||TWO_SIDED|95.0|-24.83|3.79|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||3.79|-24.83|
73848286|NCT02163577|147242382|SUPERIORITY|||||||0.9098||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.9098
73848287|NCT02163577|147242382|SUPERIORITY|||||||0.0007||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0007
73848288|NCT02163577|147242382|SUPERIORITY|||||||0.0327||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0327
73848289|NCT02163577|147242382|SUPERIORITY|||||||0.1865||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.1865
73848290|NCT02163577|147242382|SUPERIORITY|||||||0.2654||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.2654
73848291|NCT02163577|147242383|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
73848292|NCT02163577|147242383|SUPERIORITY|||||||0.0144||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0144
73848293|NCT02163577|147242383|SUPERIORITY|||||||0.0384||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0384
73848294|NCT02163577|147242383|SUPERIORITY|||||||0.0004||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0004
73848295|NCT02163577|147242383|SUPERIORITY|||||||0.9795||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.9795
73848296|NCT02163577|147242383|SUPERIORITY|||||||0.2082||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.2082
73848297|NCT02163577|147242384|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
73848298|NCT02163577|147242384|SUPERIORITY|||||||0.0251||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0251
73848299|NCT02163577|147242384|SUPERIORITY|||||||0.9124||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.9124
73848300|NCT02163577|147242384|SUPERIORITY|||||||0.0016||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0016
73848301|NCT02163577|147242384|SUPERIORITY|||||||0.5677||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.5677
73848302|NCT02163577|147242384|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848303|NCT02163577|147242385|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
73848304|NCT02163577|147242385|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
73848305|NCT02163577|147242385|SUPERIORITY|||||||0.0033||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0033
73848306|NCT02163577|147242385|SUPERIORITY|||||||0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0001
73848307|NCT02163577|147242385|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848308|NCT02163577|147242385|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73960639|NCT04956575|147456868|OTHER||Percent Difference|0.64|||||TWO_SIDED|95.0|-14.91|14.73|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||14.73|-14.91|
73960640|NCT04956575|147456868|OTHER||Percent Difference|4.45|||||TWO_SIDED|95.0|-11.19|18.59|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||18.59|-11.19|
73960641|NCT04956575|147456868|OTHER||Percent Difference|8.97|||||TWO_SIDED|95.0|-6.72|23.09|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||23.09|-6.72|
74023326|NCT02863198|147599456|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
73848309|NCT02163577|147242386|SUPERIORITY|||||||0.0014||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0014
73848310|NCT02163577|147242386|SUPERIORITY|||||||0.0028||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0028
73848311|NCT02163577|147242386|SUPERIORITY|||||||0.0536||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0536
73848312|NCT02163577|147242386|SUPERIORITY|||||||0.0002||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0002
73848313|NCT02163577|147242386|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848314|NCT02163577|147242386|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848315|NCT02163577|147242387|SUPERIORITY|||||||0.223||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.2230
73848316|NCT02163577|147242387|SUPERIORITY|||||||0.1132||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.1132
73848317|NCT02163577|147242387|SUPERIORITY|||||||0.2558||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.2558
73848318|NCT02163577|147242387|SUPERIORITY|||||||0.0814||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0814
73960642|NCT04956575|147456868|OTHER||Percent Difference|15.13|||||TWO_SIDED|95.0|-0.74|29.37|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||29.37|-0.74|
73848319|NCT02163577|147242387|SUPERIORITY|||||||0.0093||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.0093
73848320|NCT02163577|147242387|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848321|NCT02163577|147242388|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
73848322|NCT02163577|147242388|SUPERIORITY|||||||0.0006||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0006
73848323|NCT02163577|147242388|SUPERIORITY|||||||0.026||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0260
73848324|NCT02163577|147242388|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
73848325|NCT02163577|147242388|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
73848326|NCT02163577|147242388|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
74023327|NCT02863198|147599457|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared|||||||<0.05
74023328|NCT00275561|147599469|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Fisher Exact|||||||0.74
74023329|NCT00275561|147599470|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Fisher Exact|||||||0.49
74023330|NCT00275561|147599471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
74023331|NCT02511522|147599479|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|Adjusting for stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.004
74023332|NCT02511522|147599480|SUPERIORITY|||||||0.068|||||||Log Rank|Stratified Log Rank test adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.068
73960643|NCT04956575|147456868|OTHER||Percent Difference|19.08|||||TWO_SIDED|95.0|3.22|33.22|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against Yamagata-lineage at Day 29.||33.22|3.22|
73960644|NCT04956575|147456869|OTHER||Percent Difference|9.18|||||TWO_SIDED|95.0|-10.62|28.31|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||28.31|-10.62|
73960645|NCT04956575|147456869|OTHER||Percent Difference|18.09|||||TWO_SIDED|95.0|-1.81|36.61|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||36.61|-1.81|
73960646|NCT04956575|147456869|OTHER||Percent Difference|23.91|||||TWO_SIDED|95.0|4.2|41.86|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||41.86|4.20|
73960647|NCT04956575|147456869|OTHER||Percent Difference|1.15|||||TWO_SIDED|95.0|-18.41|20.6|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||20.60|-18.41|
73848327|NCT02163577|147242392|SUPERIORITY|||||||0.0003|||||||one sample t test|||Week 40||||0.0003
73848328|NCT02163577|147242392|SUPERIORITY|||||||0.0021|||||||one sample t test|||Week 40||||0.0021
73848329|NCT02163577|147242392|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
73848330|NCT02163577|147242392|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
73848331|NCT02163577|147242392|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
73848332|NCT02163577|147242392|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
73848333|NCT01847092|147242402|SUPERIORITY|||||||0.279|||||||Mixed Models Analysis|||||||0.279
73848334|NCT01847092|147242403|SUPERIORITY|||||||0.94|||||||ANCOVA|||||||0.94
73960648|NCT04956575|147456869|OTHER||Percent Difference|22.21|||||TWO_SIDED|95.0|2.09|40.6|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||40.60|2.09|
73960649|NCT04956575|147456869|OTHER||Percent Difference|36.68|||||TWO_SIDED|95.0|17.38|53.36|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||53.36|17.38|
74023333|NCT02511522|147599481|SUPERIORITY|||||||0.45|||||||Cochran-Mantel-Haenszel|adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.45
73848335|NCT01331681|147242404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.3|||<|0.0001|TWO_SIDED|97.5|6.5|12.0||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|Least square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||12.0|6.5|<0.0001
73848336|NCT01331681|147242404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|97.5|6.3|11.8||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||11.8|6.3|<0.0001
73848337|NCT01331681|147242405|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|28.7|||<|0.0001|TWO_SIDED|97.5|15.8|41.6||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 10 letters identical in both groups||41.6|15.8|<0.0001
73848338|NCT01331681|147242405|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|27.5|||<|0.0001|TWO_SIDED|97.5|14.6|40.5||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 10 letters identical in both groups||40.5|14.6|<0.0001
73848339|NCT01331681|147242406|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|23.3|||<|0.0001|TWO_SIDED|97.5|12.6|33.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 15 letters identical in both groups||33.9|12.6|<0.0001
73848340|NCT01331681|147242406|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|24.2|||<|0.0001|TWO_SIDED|97.5|13.5|34.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 15 letters identical in both groups||34.9|13.5|<0.0001
74023334|NCT02511522|147599482|SUPERIORITY|||||||0.07|||||||Cochran-Mantel-Haenszel|adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.07
73848341|NCT01331681|147242407|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|25.8|||<|0.0001|TWO_SIDED|97.5|12.2|39.4||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by \>= 2 steps identical in both groups||39.4|12.2|<0.0001
73848342|NCT01331681|147242407|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|19.3||||0.0006|TWO_SIDED|97.5|6.6|32.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by \>= 2 steps identical in both groups||32.1|6.6|0.0006
73848343|NCT01331681|147242408|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-157.0|||<|0.0001|TWO_SIDED|97.5|-190.9|-123.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||-123.1|-190.9|<0.0001
73848344|NCT01331681|147242408|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-142.8|||<|0.0001|TWO_SIDED|97.5|-179.3|-106.3||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A negative value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||-106.3|-179.3|<0.0001
73848345|NCT01331681|147242409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.41||||0.2208|TWO_SIDED|97.5|-2.01|6.82||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||6.82|-2.01|0.2208
73848346|NCT01331681|147242409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21||||0.5537|TWO_SIDED|97.5|-5.79|3.37||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||3.37|-5.79|0.5537
73848347|NCT01331681|147242410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.19||||0.5138|TWO_SIDED|97.5|-5.29|2.91|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||2.91|-5.29|0.5138
73848348|NCT01331681|147242410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37||||0.8498|TWO_SIDED|97.5|-4.79|4.05|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||4.05|-4.79|0.8498
73848349|NCT00461708|147242445|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73848350|NCT00461708|147242446|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73848351|NCT04577781|147242450|SUPERIORITY||Least Squares (LS) Mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.353||0.885|TWO_SIDED|90.0|-0.66|0.55||Mixed model repeated measure (MMRM) with treatment-by-visit interaction and baseline-by-visit interaction as fixed effects (with an unstructured variance-covariance matrix).|MMRM|||||0.55|-0.66|0.885
73848352|NCT01824290|147242487|SUPERIORITY||Mean Difference (Final Values)|23.88|STANDARD_ERROR_OF_MEAN|29.114|||TWO_SIDED|80.0|-14.25|62.0||||||||62.00|-14.25|
73848353|NCT00527618|147242493|SUPERIORITY_OR_OTHER||Slope|-0.27|||<|0.001|TWO_SIDED|95.0|-0.41|-0.14|||Mixed Models Analysis|Adjusted for baseline plasma HIV-1 RNA.|Acyclovir was coded as 0 and valacyclovir as 1. The beta-coefficient (slope) indicates the average difference in HIV-1 RNA on valacyclovir and acyclovir; a negative number indicates that plasma HIV-1 RNA was lower on valacyclovir than acyclovir.|We estimated that a sample size of 29 participants, with 4 weeks of weekly plasma HIV-1 RNA levels per treatment arm, would be required to detect a 0.25 log10 copies/ml difference in plasma HIV-1 RNA between the study arms with 80% power, at a two-sided type I error rate of 5%.||-0.14|-0.41|<0.001
73848354|NCT00527618|147242494|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95||||0.78|TWO_SIDED|95.0|0.66|1.37|||Random effects poission regression|Adjusted for age.||We estimated that 26 participants would be required to detect a 50% reduction in genital HSV shedding with 80% power, at a two-sided type I error rate of 5%.||1.37|0.66|0.78
73848355|NCT00527618|147242495|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
74023335|NCT02660580|147599483|EQUIVALENCE|MSB11022 was considered equivalent to EU-Humira if the 95% CI for the treatment difference was included in the equivalence interval \[-15%, 15%\]).|Least Square (LS) Mean difference|0.88|||||TWO_SIDED|95.0|-1.21|2.98||||||||2.98|-1.21|
74023336|NCT02660580|147599499|EQUIVALENCE|MSB11022 was considered equivalent to EU-Humira if the 95% stratified Newcombe Confidence Interval (CI) for the difference in percentage was included in the equivalence interval (-18, 18).|Percentage difference|-1.9|||||TWO_SIDED|95.0|-7.82|4.07||||||||4.07|-7.82|
74023337|NCT04178590|147599571|SUPERIORITY|||||||0.429||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.429
74023338|NCT04178590|147599572|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023339|NCT04178590|147599573|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023340|NCT04178590|147599574|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023341|NCT04178590|147599575|SUPERIORITY|||||||0.575||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.575
74023342|NCT04178590|147599576|SUPERIORITY|||||||0.575||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.575
74023343|NCT04178590|147599577|SUPERIORITY|||||||0.249||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.249
74023344|NCT04178590|147599578|SUPERIORITY|||||||0.871||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.871
74023345|NCT04178590|147599579|SUPERIORITY|||||||0.773||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.773
74023346|NCT04178590|147599580|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023347|NCT04178590|147599581|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|p\<0.05||||||0.000
74023348|NCT04178590|147599582|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023349|NCT04178590|147599583|SUPERIORITY|||||||0.063||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.063
74023350|NCT04178590|147599584|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023351|NCT04178590|147599585|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023352|NCT04178590|147599586|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023353|NCT04178590|147599587|SUPERIORITY|||||||0.085||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.085
74023354|NCT04178590|147599588|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023355|NCT04178590|147599589|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023356|NCT04178590|147599590|SUPERIORITY|||||||0.895||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.895
74023357|NCT04178590|147599591|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
74023358|NCT04178590|147599592|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
74023359|NCT04178590|147599593|SUPERIORITY|||||||0.008||||||p\<0.05|McNemar|||||||0.008
74023360|NCT04178590|147599594|SUPERIORITY|||||||0.5||||||p\<0.05|McNemar|||||||0.500
74023361|NCT04178590|147599595|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
74023362|NCT04178590|147599596|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
74023363|NCT04178590|147599597|SUPERIORITY|||||||0.4||||||p\<0.05|McNemar|||||||0.40
74023364|NCT04178590|147599598|SUPERIORITY|||||||0.999|||||||McNemar|||||||0.999
74023365|NCT04178590|147599599|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
74023366|NCT04178590|147599600|SUPERIORITY|||||||0.001||||||p\<0.05|McNemar|||||||0.001
74023367|NCT04178590|147599601|SUPERIORITY|||||||0.453||||||p\<0.05|McNemar|||||||0.453
74023368|NCT04178590|147599602|SUPERIORITY|||||||0.625||||||p\<0.05|McNemar|||||||0.625
74023369|NCT04178590|147599603|SUPERIORITY|||||||0.999|||||||McNemar|||||||0.999
74023370|NCT04178590|147599604|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
74023371|NCT04178590|147599605|SUPERIORITY|||||||0.001||||||p\<0.05|McNemar|||||||0.001
74023372|NCT04178590|147599606|SUPERIORITY|||||||0.065||||||p\<0.05|McNemar|||||||0.065
74023373|NCT04178590|147599607|SUPERIORITY|||||||0.821||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.821
74023374|NCT04178590|147599608|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023375|NCT04178590|147599609|SUPERIORITY|||||||0.001||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.001
74023376|NCT04178590|147599610|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023377|NCT04178590|147599611|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023378|NCT04178590|147599612|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023379|NCT04178590|147599613|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023380|NCT04178590|147599614|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
74023381|NCT04178590|147599615|SUPERIORITY|||||||0.671||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.671
74023382|NCT04178590|147599616|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023383|NCT04178590|147599617|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023384|NCT04178590|147599618|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
74023385|NCT04178590|147599619|SUPERIORITY|||||||0.753||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.753
74023386|NCT04178590|147599620|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023387|NCT04178590|147599621|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023388|NCT04178590|147599622|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
74023389|NCT05127486|147599659|SUPERIORITY||Odds Ratio (OR)|1.06||||0.695|TWO_SIDED|95.0|0.81|1.38|||pseudo likelihood-based repeated measure|||||1.38|0.81|0.695
74023390|NCT05127486|147599660|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.89|1.56|||pseudo likelihood-based repeated measure|||||1.56|0.89|
74023391|NCT05127486|147599661|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.89|1.79|||pseudo likelihood-based repeated measure|||||1.79|0.89|
74023392|NCT05127486|147599662|SUPERIORITY||LS Mean difference|-0.37|||||TWO_SIDED|95.0|-0.82|0.09|||Mixed Models Analysis|||||0.09|-0.82|
74023393|NCT05127486|147599663|SUPERIORITY||LS Mean difference|-0.55|||||TWO_SIDED|95.0|-1.11|0.0|||Mixed Models Analysis|||||0.00|-1.11|
74023394|NCT05127486|147599664|SUPERIORITY||LS Mean difference|-0.36|||||TWO_SIDED|95.0|-0.9|0.18|||Mixed Models Analysis|||||0.18|-0.90|
74023395|NCT05127486|147599665|SUPERIORITY||LS Mean difference|-0.18|||||TWO_SIDED|95.0|-0.73|0.37|||Mixed Models Analysis|||||0.37|-0.73|
74023396|NCT05127486|147599666|SUPERIORITY||LS Mean difference|-0.49|||||TWO_SIDED|95.0|-0.86|-0.11|||Mixed Models Analysis|||||-0.11|-0.86|
74023397|NCT05127486|147599667|SUPERIORITY||LS Mean difference|4.39|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|95.0|1.42|7.37|||ANCOVA|||Total score||7.37|1.42|
74023398|NCT05127486|147599667|SUPERIORITY||LS Mean difference|5.24|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|1.9|8.58|||ANCOVA|||RF-R||8.58|1.90|
74023399|NCT05127486|147599667|SUPERIORITY||LS Mean difference|3.88|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|1.06|6.71|||ANCOVA|||RF-P||6.71|1.06|
74023400|NCT05127486|147599667|SUPERIORITY||LS Mean difference|3.18|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-0.08|6.44|||ANCOVA|||EF||6.44|-0.08|
74023401|NCT05127486|147599668|SUPERIORITY||LS Mean difference|-2.43|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-6.94|2.08|||ANCOVA|||||2.08|-6.94|
74023402|NCT00310310|147599669|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
74084720|NCT03653026|147722713|SUPERIORITY||Adjusted Response Rate Difference|35.1|||<|0.001|TWO_SIDED|95.0|28.6|41.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||41.6|28.6|<0.001
73848356|NCT00527618|147242496|SUPERIORITY_OR_OTHER|||||||0.67|||||||Mixed Models Analysis|||||||0.67
73848357|NCT00114127|147242504|SUPERIORITY_OR_OTHER||||||<|0.132||95.0|||||t-test, 2 sided|||||||<0.132
73848358|NCT00114127|147242505|SUPERIORITY_OR_OTHER||||||<|0.292||95.0|||||t-test, 2 sided|||||||<.292
73848359|NCT03188263|147242506|OTHER|The primary planned analysis was in bright light group only and compared pre-post measurements.||||||0.046||||||A threshold of .05 was selected a priori.|Sign test|A Wilcoxon matched-pairs signed-ranks test was estimated to determine if pre-post measures of glucose levels differed significantly.||The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.||||.046
73848360|NCT03188263|147242507|OTHER|The primary planned analysis was in bright light group only and compared pre-post measurements.||||||0.35||||||A threshold of .05 was selected a priori.|Sign test|A Wilcoxon matched-pairs signed-ranks test was estimated to determine if pre-post measures of glucose levels differed significantly.||The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.||||.35
73848361|NCT00881894|147242508|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9864||||||90.0|0.9103|1.0688|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0688|0.9103|
73848362|NCT00881894|147242509|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9584||||||90.0|0.8861|1.0367|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0367|0.8861|
73848363|NCT00881894|147242510|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9896||||||90.0|0.9179|1.0671|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).||Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0671|0.9179|
73848364|NCT00539240|147242567|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.04
73848365|NCT00539240|147242567|SUPERIORITY_OR_OTHER|||||||0.5||||||P\<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.50
73848366|NCT00539240|147242568|SUPERIORITY_OR_OTHER|||||||0.19||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons (no post-hoc contrasts performed)|ANCOVA|Adjusted for baseline score and personality traits (SCL-90)||||||0.19
73848367|NCT00539240|147242569|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity.||||||0.04
73848368|NCT00539240|147242569|SUPERIORITY_OR_OTHER|||||||0.5||||||P\<0.05 considered statistically significant, no adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.50
73848369|NCT00539240|147242570|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.04
73848370|NCT00539240|147242570|SUPERIORITY_OR_OTHER|||||||0.2||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity.||||||0.20
73848371|NCT00363311|147242571|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.56||||0.009||95.0|0.36|0.87||Statistical data are for Year 1.5|Log Rank|||||0.87|0.36|0.009
73848372|NCT00363311|147242571|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.61||||0.007||95.0|0.43|0.88||Statistical data are for Overall (Years 0-3)|Log Rank|||||0.88|0.43|0.007
73848373|NCT00363311|147242572|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.46||||0.13||95.0|0.16|1.31||Statistical data are for Year 1.5|Log Rank|||||1.31|0.16|0.13
73848374|NCT00363311|147242572|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.48||||0.053||95.0|0.22|1.03||Statistical data are for Overall (Years 0-3)|Log Rank|||||1.03|0.22|0.053
73848375|NCT00363311|147242573|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.59||||0.031||95.0|0.36|0.96||Statistical data are for Year 1.5|Log Rank|||||0.96|0.36|0.031
74023403|NCT00310310|147599670|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 1 sided|||||||0.023
74023404|NCT00310310|147599671|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 1 sided|||||||0.8
74023405|NCT00310310|147599673|SUPERIORITY_OR_OTHER|||||||0.96|||||||t-test, 1 sided|||||||0.96
74023406|NCT00310310|147599674|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 1 sided|||||||0.59
74023407|NCT00310310|147599675|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 1 sided|||||||0.00
74023408|NCT00310310|147599676|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
74023409|NCT00310310|147599677|SUPERIORITY_OR_OTHER|||||||0.08|||||||t-test, 1 sided|||||||0.08
74023410|NCT00310310|147599678|SUPERIORITY_OR_OTHER|||||||0.38|||||||t-test, 1 sided|||||||0.38
74023411|NCT04971226|147599684|SUPERIORITY||Risk Difference (RD)|18.88|||<|0.001|TWO_SIDED|95.0|9.59|28.17|||Mantel Haenszel||The Estimate Value is a percentage.||The Confidence Interval are percentages.|28.17|9.59|<0.001
73848376|NCT00363311|147242573|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.7||||0.079||95.0|0.46|1.05||Statistical data are for Overall (Years 0-3)|Log Rank|||||1.05|0.46|0.079
73848377|NCT00363311|147242574|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Fisher Exact|||||||0.65
73848378|NCT00363311|147242575|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Fisher Exact|||||||0.024
73848379|NCT00363311|147242582|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.20
73848380|NCT00363311|147242583|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.039
73848381|NCT00363311|147242585|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.80
73848382|NCT00363311|147242586|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||||||0.12
73848383|NCT01595529|147242601|NON_INFERIORITY|The primary analysis was a non-inferiority test comparing the proportion of subjects with symptomatic UTIs at the TOC visit to evaluate whether the difference was within the 5% equivalence interval. This test was conducted by calculating the one-sided 95% upper confidence limit for the difference in symptomatic UTI (treatment failure) rate. If this limit was less than or equal to the equivalence interval (0.05), then would conclude that short course therapy is not inferior to standard therapy.|Risk Difference (RD)|0.035569|||||ONE_SIDED|95.0||0.054844||||||||0.054844||
73848384|NCT01595529|147242602|NON_INFERIORITY|The primary analysis was a non-inferiority test comparing the proportion of subjects with symptomatic UTIs at the TOC visit to evaluate whether the difference was within the 5% equivalence interval. This test was conducted by calculating the one-sided 95% upper confidence limit for the difference in symptomatic UTI (treatment failure) rate. If this limit was less than or equal to the equivalence interval (0.05), then would conclude that short course therapy is not inferior to standard therapy.|Risk Difference (RD)|0.022169|||||ONE_SIDED|95.0||0.03939||||||||0.03939||
73900182|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|49.0|||||TWO_SIDED|95.0|38.9|58.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.5|38.9|
73960650|NCT04956575|147456869|OTHER||Percent Difference|-37.71|||||TWO_SIDED|95.0|-53.36|-20.45|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||-20.45|-53.36|
73960651|NCT04956575|147456869|OTHER||Treatment Difference|-26.18|||||TWO_SIDED|95.0|-43.66|-6.9|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||-6.90|-43.66|
73960652|NCT04956575|147456869|OTHER||Percent Difference|-19.66|||||TWO_SIDED|95.0|-37.95|0.11|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.11|-37.95|
73848385|NCT01595529|147242603|SUPERIORITY||Risk Difference (RD)|-0.00356|||||TWO_SIDED|95.0|-0.03323|0.026102||||||||0.026102|-0.03323|
74023412|NCT04971226|147599716|SUPERIORITY||Risk Difference (RD)|29.55|||<|0.001|TWO_SIDED|95.0|16.91|42.18|||Mantel Haenszel||The Estimate Value is a percentage.||The Confidence Interval are percentages.|42.18|16.91|<0.001
73848386|NCT01595529|147242604|SUPERIORITY||Risk Difference (RD)|-0.00994|||||TWO_SIDED|95.0|-0.04012|0.020236||||||||0.020236|-0.04012|
73848387|NCT01595529|147242605|SUPERIORITY|||||||0.2282|||||||Chi-squared|||At Test of Cure Visit||||0.2282
73848388|NCT01595529|147242605|SUPERIORITY|||||||0.4876|||||||Chi-squared|||At Outcome Assessment Visit||||0.4876
73848389|NCT01595529|147242606|SUPERIORITY|||||||0.4184|||||||Chi-squared|||At Test of Cure Visit||||0.4184
73848390|NCT01595529|147242606|SUPERIORITY|||||||0.9782|||||||Chi-squared|||At Outcome Assessment Visit||||0.9782
73848391|NCT01595529|147242607|SUPERIORITY||Risk Difference (RD)|-0.05277|||||TWO_SIDED|95.0|-0.08857|-0.01698||||||||-0.01698|-0.08857|
73848392|NCT01595529|147242608|SUPERIORITY||Risk Difference (RD)|-0.05664|||||TWO_SIDED|95.0|-0.09479|-0.0185||||||||-0.01850|-0.09479|
73848393|NCT01595529|147242609|SUPERIORITY||Risk Difference (RD)|-0.03056|||||TWO_SIDED|95.0|-0.07744|0.016323||||||||0.016323|-0.07744|
73848394|NCT01595529|147242610|SUPERIORITY||Risk Difference (RD)|-0.01094|||||TWO_SIDED|95.0|-0.058|0.036117||||||||0.036117|-0.0580|
73848395|NCT01595529|147242611|SUPERIORITY||Risk Difference (RD)|-0.10373|||||TWO_SIDED|95.0|-0.14161|-0.06585||||||||-0.06585|-0.14161|
73848396|NCT01595529|147242612|SUPERIORITY||Risk Difference (RD)|-0.09198|||||TWO_SIDED|95.0|-0.13006|-0.05391||||||||-0.05391|-0.13006|
73848397|NCT04016714|147242613|OTHER||Difference in percentage vs Prevenar 13™|-5.5|||=|0.05|TWO_SIDED|95.0|-11.0|0.0|||Miettinen & Nurminen method|||Injection-site erythema||0.0|-11.0|= 0.050
73848398|NCT04016714|147242613|OTHER||Difference in percentage vs Prevenar 13™|-2.1|||=|0.46|TWO_SIDED|95.0|-7.7|3.5|||Miettinen & Nurminen method|||Injection-site induration||3.5|-7.7|= 0.460
73848399|NCT04016714|147242613|OTHER||Difference in percentage vs Prevenar 13™|3.4|||=|0.225|TWO_SIDED|95.0|-2.1|8.9|||Miettinen & Nurminen method|||Injection-site pain||8.9|-2.1|= 0.225
73848400|NCT04016714|147242613|OTHER||Difference in percentage vs Prevenar 13™|2.3|||=|0.43|TWO_SIDED|95.0|-3.4|7.9|||Miettinen & Nurminen method|||Injection-site swelling||7.9|-3.4|= 0.430
73848401|NCT04016714|147242614|OTHER||Difference in percentage vs Prevenar 13™|-3.5|||=|0.229|TWO_SIDED|95.0|-9.1|2.2|||Miettinen & Nurminen method|||Decreased appetite||2.2|-9.1|= 0.229
73848402|NCT04016714|147242614|OTHER||Difference in percentage vs Prevenar 13™|2.2|||=|0.077|TWO_SIDED|95.0|-0.2|4.7|||Miettinen & Nurminen method|||Irritability||4.7|-0.2|= 0.077
73848403|NCT04016714|147242614|OTHER||Difference in percentage vs Prevenar 13™|-0.6|||=|0.793|TWO_SIDED|95.0|-5.4|4.1|||Miettinen & Nurminen method|||Somnolence||4.1|-5.4|= 0.793
73848404|NCT04016714|147242614|OTHER||Difference in percentage vs Prevenar 13™|-4.6|||=|0.045|TWO_SIDED|95.0|-9.1|-0.1|||Miettinen & Nurminen method|||Urticaria||-0.1|-9.1|= 0.045
73848405|NCT04016714|147242615|OTHER||Difference in percentage vs Prevenar 13™|0.0|||||TWO_SIDED|95.0|-0.9|0.9||||||Vaccine-related SAEs||0.9|-0.9|
73848406|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% confidence interval (CI) for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.3|-0.6|||Miettinen & Nurminen method|||Serotype 1||-0.6|-4.3|< 0.001
73848407|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|10.5|||<|0.001|TWO_SIDED|95.0|6.6|14.6|||Miettinen & Nurminen method|||Serotype 3||14.6|6.6|< 0.001
73848408|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-1.9|||<|0.001|TWO_SIDED|95.0|-4.0|0.0|||Miettinen & Nurminen method|||Serotype 4||0.0|-4.0|< 0.001
73848409|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.4|0.8|||Miettinen & Nurminen method|||Serotype 5||0.8|-1.4|< 0.001
73848410|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.5|1.0|||Miettinen & Nurminen method|||Serotype 6A||1.0|-1.5|< 0.001
73848411|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-1.2|1.5|||Miettinen & Nurminen method|||Serotype 6B||1.5|-1.2|< 0.001
73848412|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.4|1.4|||Miettinen & Nurminen method|||Serotype 7F||1.4|-0.4|< 0.001
73848413|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Serotype 9V||1.2|-0.8|< 0.001
73848414|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.7|0.7|||Miettinen & Nurminen method|||Serotype 14||0.7|-1.7|< 0.001
73848415|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.6|1.5|||Miettinen & Nurminen method|||Serotype 18C||1.5|-0.6|< 0.001
73848416|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.3|0.7|||Miettinen & Nurminen method|||Serotype 19A||0.7|-1.3|< 0.001
73848417|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Serotype 19F||1.2|-0.8|< 0.001
73848418|NCT04016714|147242616|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.9|||<|0.001|TWO_SIDED|95.0|-1.2|3.0|||Miettinen & Nurminen method|||Serotype 23F||3.0|-1.2|< 0.001
73848419|NCT04016714|147242616|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage point difference|94.0|||<|0.001|TWO_SIDED|95.0|91.6|95.8|||Miettinen & Nurminen method|||Serotype 22F||95.8|91.6|< 0.001
73900183|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|34.0|||||TWO_SIDED|95.0|26.6|42.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||42.2|26.6|
73848420|NCT04016714|147242616|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage point difference|97.2|||<|0.001|TWO_SIDED|95.0|95.4|98.4|||Miettinen & Nurminen method|||Serotype 33F||98.4|95.4|< 0.001
73900184|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|27.0|||||TWO_SIDED|95.0|21.6|33.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.0|21.6|
74023413|NCT02623972|147599725|OTHER||Pathelogic Complete Response Rate|30.0|||||TWO_SIDED||||||Simon minimax two-stage design||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 10% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 30% then the regimen is worthy of further study.|Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.10, Alternative hypothesis that proportion pCR ≥ 0.30. Hypothesized False Positive Rate(α)=10%; Hypothesized False Negative Rate(1-β)=10%.||||
74023414|NCT02623972|147599725|OTHER||Pathelogic Complete Response Rate|23.0|||||TWO_SIDED||||||Simon minimax two-stage design||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 2% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 23% then the regimen is worthy of further study.|Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.02, Alternative hypothesis that proportion pCR ≥ 0.23. Hypothesized False Positive Rate(α)=5%; Hypothesized False Negative Rate(1-β)=10%.||||
74023415|NCT03431012|147599821|OTHER||||||>|0.05||||||Sidak corrections were used to adjust for multiple analyses.|ANCOVA|ANCOVAs, setting baseline intentions as a covariate, were performed to determine whether post-exposure mean intentions differed between groups.||We predicted that Virus Agency (VA) and Positive Framing (PF) would lead to greater adherence intentions, compared to the human agency (HA) and negative framing (NF) versions respectively.||||>.05
74023416|NCT03431012|147599822|OTHER||||||=|0.113||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher worry than the human agency assignment.||||=.113
74023417|NCT03431012|147599823|OTHER||||||=|0.809||||||Sidak corrections were used to adjust for multiple analyses|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of susceptibility than the human agency assignment.||||=.809
73848421|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.58|||<|0.001|TWO_SIDED|95.0|0.54|0.63|||t-test, 1 sided|||Serotype 1||0.63|0.54|< 0.001
73848422|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|1.31|||<|0.001|TWO_SIDED|95.0|1.2|1.43|||t-test, 1 sided|||Serotype 3||1.43|1.20|< 0.001
73848423|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.78|||t-test, 1 sided|||Serotype 4||0.78|0.63|< 0.001
73848424|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.62|||<|0.001|TWO_SIDED|95.0|0.56|0.68|||t-test, 1 sided|||Serotype 5||0.68|0.56|< 0.001
73848425|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.6|||<|0.001|TWO_SIDED|95.0|0.54|0.67|||t-test, 1 sided|||Serotype 6A||0.67|0.54|< 0.001
74023418|NCT03431012|147599824|OTHER|||||||0.025||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of severity of the pandemic than the human agency assignment.||||0.025
74023419|NCT03431012|147599825|OTHER||||||=|0.199||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that the Agency Assignment would not affect self-efficacy, i.e. people's perceived ability to use the antivirals as recommended.||||=0.199
74023420|NCT03431012|147599826|OTHER||||||=|0.484||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to higher response efficacy.||||=0.484
74023421|NCT03431012|147599827|OTHER||||||=|0.494||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to lower response costs compared to Negative Framing.||||=0.494
74023422|NCT01025635|147599833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Mantel-Haenszel|study center adjusted||||||0.017
74023423|NCT01025635|147599834|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|with factors treatment group, study center, and baseline lesion count as covariate||||||<0.001
74023424|NCT00929240|147599839|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.383|||<|0.0001|TWO_SIDED|95.0|0.266|0.551||Stratified by interactive voice/Web response system (IVRS), estrogen receptor (ER) status, visceral metastasis (yes/no), response to initial phase, and lactate dehydrogenase (LDH) level.|Log Rank||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|||0.551|0.266|<0.0001
74023425|NCT00929240|147599839|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.429|||<|0.0001|TWO_SIDED|95.0|0.309|0.597|||Log Rank|Unstratified analysis||||0.597|0.309|<0.0001
74023426|NCT00929240|147599840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1||||0.113|TWO_SIDED|95.0|-2.1|20.3|||Chi-squared||CIs with Hauck-Anderson adjustment for difference in rates of bevacizumab + capecitabine arm to bevacizumab alone arm.|||20.3|-2.1|0.113
74023427|NCT00929240|147599841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.58|TWO_SIDED|95.0|-2.6|4.6|||Chi-squared||CIs with Hauck-Anderson adjustment for difference in rates of Bevacizumab+Capecitabine group to Bevacizumab only group.|||4.6|-2.6|0.580
74023428|NCT00929240|147599843|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425|||<|0.0003|TWO_SIDED|95.0|0.263|0.685||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank|||||0.685|0.263|<0.0003
74023429|NCT00929240|147599843|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.516||||0.002|TWO_SIDED|95.0|0.334|0.798||Unstratified analysis|Log Rank|||||0.798|0.334|0.002
73900185|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|23.0|||||TWO_SIDED|95.0|15.5|32.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.0|15.5|
73900186|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|30.0|||||TWO_SIDED|95.0|22.9|38.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||38.1|22.9|
73900187|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|43.0|||||TWO_SIDED|95.0|35.1|50.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||50.6|35.1|
73900188|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|51.0|||||TWO_SIDED|95.0|39.3|60.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||60.9|39.3|
73900189|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|41.0|||||TWO_SIDED|95.0|29.9|50.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||50.2|29.9|
73900190|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|19.0|||||TWO_SIDED|95.0|12.9|24.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||24.6|12.9|
73960653|NCT04956575|147456869|OTHER||Percent Difference|-23.43|||||TWO_SIDED|95.0|-41.09|-4.26|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||-4.26|-41.09|
73960654|NCT04956575|147456869|OTHER||Percent Difference|-4.44|||||TWO_SIDED|95.0|-24.09|15.59|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of against Afluria Quadrivalent Yamagata-lineage at Day 29.||15.59|-24.09|
73960655|NCT04956575|147456869|OTHER||Percent Difference|-8.79|||||TWO_SIDED|95.0|-28.13|11.27|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||11.27|-28.13|
73960656|NCT03593876|147456875|OTHER||||||||||||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess mean participant-therapist communication scores across intervention sessions. The mean and standard deviation of these scores was 3.00 (1.00). The a priori criterion for feasibility was a mean score of 2.0 or greater.|||
73960657|NCT03593876|147456876|OTHER||Mean Difference (Net)|51.71|STANDARD_DEVIATION|21.04|||TWO_SIDED|||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.|The repeated measures effect size of change was Cohen's d(rm)=3.08.|||
73900191|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|28.0|||||TWO_SIDED|95.0|17.9|37.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||37.8|17.9|
73900192|NCT02446743|147331794|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|6.4|20.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.1|6.4|
73900193|NCT02446743|147331795|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|2.6|||||TWO_SIDED|95.0|2.11|3.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.20|2.11|
73900194|NCT02446743|147331795|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|11.0|||||TWO_SIDED|95.0|8.85|15.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||15|8.85|
73900195|NCT02446743|147331795|OTHER|Vaccine comparison-Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|2.18|||||TWO_SIDED|95.0|1.7|2.79|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.79|1.70|
73900196|NCT02446743|147331795|OTHER|Vaccine comparison-post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|12.0|||||TWO_SIDED|95.0|8.22|17.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||17|8.22|
73900197|NCT02446743|147331795|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|3.04|||||TWO_SIDED|95.0|2.2|4.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.20|2.20|
73900198|NCT02446743|147331795|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|11.0|||||TWO_SIDED|95.0|7.75|16.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||16|7.75|
73900199|NCT02446743|147331795|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|16.0|||||TWO_SIDED|95.0|12.0|21.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||21|12|
73900200|NCT02446743|147331795|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|68.0|||||TWO_SIDED|95.0|51.0|90.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||90|51|
73900201|NCT02446743|147331795|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|18.0|||||TWO_SIDED|95.0|13.0|26.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||26|13|
73900202|NCT02446743|147331795|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|74.0|||||TWO_SIDED|95.0|51.0|107.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||107|51|
73900203|NCT02446743|147331795|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|14.0|||||TWO_SIDED|95.0|8.99|22.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||22|8.99|
73900204|NCT02446743|147331795|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|63.0|||||TWO_SIDED|95.0|41.0|95.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||95|41|
73900205|NCT02446743|147331795|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.24|1.75|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.75|1.24|
73900206|NCT02446743|147331795|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|5.9|||||TWO_SIDED|95.0|4.49|7.76|||ANOVA|||Post booster dose/ post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||7.76|4.49|
73900207|NCT02446743|147331795|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.13|1.54|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||1.54|1.13|
73900208|NCT02446743|147331795|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|8.27|||||TWO_SIDED|95.0|5.83|12.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||12|5.83|
73900209|NCT02446743|147331795|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|1.64|||||TWO_SIDED|95.0|1.22|2.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.20|1.22|
74023430|NCT00929240|147599846|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.383|||<|0.0001|TWO_SIDED|95.0|0.266|0.551||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank||Stratification variables are randomisation stratification parameters as of IVRS: ER status, Visceral metastasis (yes/no), Response to initial phase, LDH concentration level.|||0.551|0.266|<0.0001
74023431|NCT00929240|147599846|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.305|0.591||Unstratified analysis|Log Rank||Hazard ratio was determined using the cox regression model.|||0.591|0.305|<0.0001
74023432|NCT05292755|147599850|OTHER|One-way ANOVA was used to compare mean Faith's phylogenetic diversity before and after treatment for each intervention group at a two-tailed 95% confidence interval.||||||0.232|||||||ANOVA|||||||0.232
74023433|NCT05292755|147599851|OTHER|||||||0.224|||||||ANOVA|||ANOVA was used to compare mean Shannon's diversity indices before and after treatment for each intervention group at a two-tailed 95% confidence interval.||||0.224
74023434|NCT05292755|147599852|OTHER|||||||0.227|||||||Repeated measures Mann-U-Whitney|||Repeated measures Mann-U-Whitney tests were used to compare changes in weighted and unweighted UniFrac distances between intervention groups before and after intervention at a two-tailed 95% confidence interval.||||0.227
74023435|NCT00432809|147599863|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Chi-squared|||||||0.002
74023436|NCT00432809|147599863|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Chi-squared|||||||0.008
73848426|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.0|||t-test, 1 sided|||Serotype 6B||1.00|0.79|< 0.001
73848427|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.69|0.81|||t-test, 1 sided|||Serotype 7F||0.81|0.69|< 0.001
73848428|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.64|0.76|||t-test, 1 sided|||Serotype 9V||0.76|0.64|< 0.001
73848429|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.78|||<|0.001|TWO_SIDED|95.0|0.7|0.87|||t-test, 1 sided|||Serotype 14||0.87|0.70|< 0.001
73848430|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.77|0.92|||t-test, 1 sided|||Serotype 18C||0.92|0.77|< 0.001
73848431|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.82|||t-test, 1 sided|||Serotype 19A||0.82|0.68|< 0.001
74023437|NCT00432809|147599863|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Not adjusted for multiple comparisons|Chi-squared|||||||0.59
74023438|NCT00432809|147599867|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74023439|NCT00432809|147599867|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74023440|NCT00432809|147599867|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
74023441|NCT00432809|147599868|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
74023442|NCT00432809|147599868|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
74023443|NCT00432809|147599868|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
74023444|NCT00432809|147599869|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74023445|NCT00432809|147599869|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||||||0.003
74023446|NCT00432809|147599869|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||||||0.23
74023447|NCT00432809|147599870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Medical Therapy vs. Gastric Bypass||||<0.001
74023448|NCT00432809|147599870|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74023449|NCT00432809|147599870|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Chi-squared|||||||0.10
74023450|NCT00432809|147599871|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74023451|NCT00432809|147599871|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74023452|NCT00432809|147599871|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
74023453|NCT00432809|147599872|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74023454|NCT00432809|147599872|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74023455|NCT00432809|147599872|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
74023456|NCT00432809|147599873|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74023457|NCT00432809|147599873|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74023458|NCT00432809|147599873|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
74023459|NCT00432809|147599874|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74023460|NCT00432809|147599874|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74023461|NCT00432809|147599874|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
74023462|NCT00432809|147599875|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||||||0.87
74023463|NCT00432809|147599875|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
74023464|NCT00432809|147599875|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||||||0.46
74023465|NCT00432809|147599876|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
74023466|NCT00432809|147599876|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
74023467|NCT00432809|147599876|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||||||0.98
74023468|NCT00432809|147599877|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
74023469|NCT00432809|147599877|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.08
73848432|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.72|0.87|||t-test, 1 sided|||Serotype 19F||0.87|0.72|< 0.001
73848433|NCT04016714|147242617|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.81|1.0|||t-test, 1 sided|||Serotype 23F||1.00|0.81|< 0.001
73848434|NCT04016714|147242617|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2- sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC ratio|68.34|||<|0.001|TWO_SIDED|95.0|61.73|75.65|||t-test, 1 sided|||Serotype 22F||75.65|61.73|< 0.001
73848435|NCT04016714|147242617|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC ratio|48.99|||<|0.001|TWO_SIDED|95.0|44.45|54.01|||t-test, 1 sided|||Serotype 33F||54.01|44.45|< 0.001
73848436|NCT04016714|147242618|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Diphtheria toxoid||1.0|-0.6|< 0.001
73848437|NCT04016714|147242618|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Tetanus toxoid||1.0|-0.6|< 0.001
73848438|NCT04016714|147242618|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Pertussis - PT||1.0|-0.6|< 0.001
73848439|NCT04016714|147242618|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Pertussis - FHA||1.0|-0.6|< 0.001
73848440|NCT04016714|147242618|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Pertussis - FIM 2/3||1.2|-0.8|< 0.001
73848441|NCT04016714|147242618|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Pertussis - PRN||1.2|-0.8|< 0.001
73848442|NCT04016714|147242618|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|-1.1|||<|0.001|TWO_SIDED|95.0|-3.3|0.9|||Miettinen & Nurminen method|||Hib-PRP||0.9|-3.3|< 0.001
73848443|NCT04016714|147242618|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|-0.6|||<|0.001|TWO_SIDED|95.0|-2.0|0.5|||Miettinen & Nurminen method|||HBsAg||0.5|-2.0|< 0.001
73848444|NCT04016714|147242618|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen method|||Poliovirus 1||0.9|-0.9|< 0.001
73900210|NCT02446743|147331795|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|4.36|||||TWO_SIDED|95.0|2.88|6.58|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||6.58|2.88|
73900211|NCT02446743|147331795|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|1.3|||||TWO_SIDED|95.0|0.97|1.75|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.75|0.97|
73900212|NCT02446743|147331795|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|2.6|||||TWO_SIDED|95.0|2.08|3.25|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.25|2.08|
73960658|NCT03593876|147456877|OTHER||Mean Difference (Net)|11.02|STANDARD_DEVIATION|7.24|||TWO_SIDED|||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.|The repeated measures effect size of change, Cohen's d(rm)=1.70|||
73960659|NCT00432458|147456880|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|Model was stratified by beta-2 microglobulin (high vs low), lytic bone lesions (present vs not) and bone marrow labeling index (high vs low)||||||0.02
73960660|NCT00432458|147456881|SUPERIORITY_OR_OTHER|||||||0.0048||95.0|||||Chi-squared|||||||0.0048
73960661|NCT00432458|147456882|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73960662|NCT03034915|147456911|OTHER||Mean Difference (Net)|0.066|STANDARD_ERROR_OF_MEAN|0.0118|<|0.001|TWO_SIDED|95.0|0.043|0.089|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.089|0.043|<0.001
73960663|NCT03034915|147456911|OTHER||Mean Difference (Net)|0.141|STANDARD_ERROR_OF_MEAN|0.0117|<|0.001|TWO_SIDED|95.0|0.118|0.164|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.164|0.118|<0.001
73960664|NCT03034915|147456911|OTHER||Mean Difference (Net)|0.075|STANDARD_ERROR_OF_MEAN|0.0119|<|0.001|TWO_SIDED|95.0|0.051|0.098|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||0.098|0.051|<0.001
73960665|NCT03034915|147456912|OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.157||0.018|TWO_SIDED|95.0|0.06|0.68|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.68|0.06|0.018
73960666|NCT03034915|147456912|OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.155||0.004|TWO_SIDED|95.0|0.15|0.76|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.76|0.15|0.004
73960667|NCT03034915|147456912|OTHER||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.159||0.61|TWO_SIDED|95.0|-0.23|0.39|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24|||0.39|-0.23|0.610
73960668|NCT03034915|147456913|OTHER||Odds Ratio (OR)|1.43|||<|0.001|TWO_SIDED|95.0|1.17|1.75|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 24|||1.75|1.17|<0.001
73960669|NCT03034915|147456913|OTHER||Odds Ratio (OR)|1.48|||<|0.001|TWO_SIDED|95.0|1.21|1.81|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24|||1.81|1.21|<0.001
73960670|NCT03034915|147456913|OTHER||Odds Ratio (OR)|1.03||||0.755|TWO_SIDED|95.0|0.84|1.27|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.27|0.84|0.755
73960671|NCT03034915|147456914|OTHER||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.213||0.013|TWO_SIDED|95.0|-0.95|-0.11|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24|||-0.11|-0.95|0.013
73960672|NCT03034915|147456914|OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.211|<|0.001|TWO_SIDED|95.0|-1.25|-0.42|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24..|||-0.42|-1.25|<0.001
73960673|NCT03034915|147456914|OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.214||0.159|TWO_SIDED|95.0|-0.72|0.12|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24|||0.12|-0.72|0.159
73960674|NCT03034915|147456915|OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.114||0.016|TWO_SIDED|95.0|-0.5|-0.05||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.|||-0.05|-0.50|0.016
73960675|NCT03034915|147456915|OTHER||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-0.68|-0.23||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||-0.23|-0.68|<0.001
73960676|NCT03034915|147456915|OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.115||0.115|TWO_SIDED|95.0|-0.41|0.04||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.04|-0.41|0.115
73960677|NCT03034915|147456915|OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.063||0.247|TWO_SIDED|95.0|-0.2|0.05||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.|||0.05|-0.20|0.247
73960678|NCT03034915|147456915|OTHER||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.063||0.042|TWO_SIDED|95.0|-0.25|0.0||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||0.00|-0.25|0.042
73960679|NCT03034915|147456915|OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.063||0.391|TWO_SIDED|95.0|-0.18|0.07||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.07|-0.18|0.391
73960680|NCT03034915|147456915|OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.014|TWO_SIDED|95.0|-0.31|-0.04||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24|||-0.04|-0.31|0.014
73960681|NCT03034915|147456915|OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.37|-0.1||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comapring UMEC/VI versus salmeterol at Week 21 to Week 24.|||-0.10|-0.37|<0.001
73960682|NCT03034915|147456915|OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.34|TWO_SIDED|95.0|-0.2|0.07||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.07|-0.20|0.340
73960683|NCT03034915|147456916|OTHER||Odds Ratio (OR)|1.52|||<|0.001|TWO_SIDED|95.0|1.22|1.89|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 21 to Week 24|||1.89|1.22|<0.001
73960684|NCT03034915|147456916|OTHER||Odds Ratio (OR)|1.53|||<|0.001|TWO_SIDED|95.0|1.23|1.9|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||1.90|1.23|<0.001
73960685|NCT03034915|147456916|OTHER||Odds Ratio (OR)|1.0||||0.969|TWO_SIDED|95.0|0.8|1.26|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 21 to Week 24.|||1.26|0.80|0.969
73960686|NCT03034915|147456917|OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.672||0.709|TWO_SIDED|95.0|-1.07|1.57|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||1.57|-1.07|0.709
73900213|NCT02446743|147331795|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|1.4|||||TWO_SIDED|95.0|0.9|2.18|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.18|0.90|
73900214|NCT02446743|147331795|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|2.79|||||TWO_SIDED|95.0|2.04|3.81|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.81|2.04|
73900215|NCT02446743|147331795|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|1.23|||||TWO_SIDED|95.0|0.82|1.82|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||1.82|0.82|
73900216|NCT02446743|147331795|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|2.45|||||TWO_SIDED|95.0|1.79|3.36|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.36|1.79|
73900217|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|27.0|||||TWO_SIDED|95.0|20.7|33.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.0|20.7|
73900218|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|29.0|||||TWO_SIDED|95.0|19.3|38.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||38.7|19.3|
73900219|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|26.0|||||TWO_SIDED|95.0|18.3|33.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.9|18.3|
73900220|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|22.0|||||TWO_SIDED|95.0|15.9|27.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval or the difference was calculated using the method of Miettinen and Nurminen||27.9|15.9|
73900221|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|19.0|||||TWO_SIDED|95.0|11.5|28.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.5|11.5|
73900222|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|23.0|||||TWO_SIDED|95.0|14.6|31.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||31.9|14.6|
73900223|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|38.0|||||TWO_SIDED|95.0|29.8|45.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||45.4|29.8|
74023470|NCT00432809|147599877|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.17
74023471|NCT00432809|147599878|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73900224|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|55.0|||||TWO_SIDED|95.0|43.5|64.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||64.7|43.5|
73900225|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|24.0|||||TWO_SIDED|95.0|12.9|35.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||35.1|12.9|
73900226|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|23.0|||||TWO_SIDED|95.0|14.7|30.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||30.8|14.7|
74023472|NCT00432809|147599878|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
74023473|NCT00432809|147599878|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.59
73848445|NCT04016714|147242618|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.1|||Miettinen & Nurminen method|||Poliovirus 2||1.1|-0.6|< 0.001
73848446|NCT04016714|147242618|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.8|0.7|||Miettinen & Nurminen method|||Poliovirus 3||0.7|-0.8|< 0.001
74023474|NCT00432809|147599879|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73848447|NCT04016714|147242620|OTHER||GMC ratio|0.82|||||TWO_SIDED|95.0|0.75|0.89||||||Serotype 1||0.89|0.75|
73848448|NCT04016714|147242620|OTHER||GMC ratio|1.81|||||TWO_SIDED|95.0|1.66|1.98||||||Serotype 3||1.98|1.66|
73848449|NCT04016714|147242620|OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.99|1.21||||||Serotype 4||1.21|0.99|
73848450|NCT04016714|147242620|OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.81|1.01||||||Serotype 5||1.01|0.81|
73848451|NCT04016714|147242620|OTHER||GMC ratio|0.44|||||TWO_SIDED|95.0|0.38|0.5||||||Serotype 6A||0.50|0.38|
73848452|NCT04016714|147242620|OTHER||GMC ratio|1.73|||||TWO_SIDED|95.0|1.46|2.05||||||Serotype 6B||2.05|1.46|
73848453|NCT04016714|147242620|OTHER||GMC ratio|0.78|||||TWO_SIDED|95.0|0.71|0.84||||||Serotype 7F||0.84|0.71|
73848454|NCT04016714|147242620|OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.9|1.12||||||Serotype 9V||1.12|0.90|
73848455|NCT04016714|147242620|OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.89|1.18||||||Serotype 14||1.18|0.89|
73848456|NCT04016714|147242620|OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.68|0.82||||||Serotype 18C||0.82|0.68|
73848457|NCT04016714|147242620|OTHER||GMC ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81||||||Serotype 19A||0.81|0.64|
73900227|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|24.0|||||TWO_SIDED|95.0|12.2|35.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||35.5|12.2|
73900228|NCT02446743|147331797|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|22.0|||||TWO_SIDED|95.0|10.6|32.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.9|10.6|
73960687|NCT03034915|147456917|OTHER||Mean Difference (Net)|-1.69|STANDARD_ERROR_OF_MEAN|0.665||0.011|TWO_SIDED|95.0|-2.99|-0.39|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||-0.39|-2.99|0.011
73848458|NCT04016714|147242620|OTHER||GMC ratio|0.69|||||TWO_SIDED|95.0|0.62|0.77||||||Serotype 19F||0.77|0.62|
73848459|NCT04016714|147242620|OTHER||GMC ratio|1.32|||||TWO_SIDED|95.0|1.16|1.51||||||Serotype 23F||1.51|1.16|
73848460|NCT04016714|147242620|SUPERIORITY||GMC ratio|81.01|||||TWO_SIDED|95.0|73.12|89.75||||||Serotype 22F||89.75|73.12|
73848461|NCT04016714|147242620|OTHER||GMC ratio|7.81|||||TWO_SIDED|95.0|6.82|8.94||||||Serotype 33F||8.94|6.82|
73848462|NCT01722929|147242668|OTHER||||||<|0.0001||||||p-value is for the main effect for the Treatment, Time, and Treatment\*Time interaction.|Mixed Models Analysis|||A mixed ANOVA was performed with the arms as a between factor and the three times as the within factor.||||<0.0001
73848463|NCT01847443|147242684|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.107|||||TWO_SIDED|90.0|1.07|1.147|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)||1.147|1.070|
73848464|NCT01847443|147242689|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.098|||||TWO_SIDED|90.0|1.061|1.137|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)||1.137|1.061|
73848465|NCT01847443|147242690|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.044|||||TWO_SIDED|90.0|1.002|1.089|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in Cmax||1.089|1.002|
73848466|NCT01847443|147242691|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.071|||||TWO_SIDED|90.0|1.028|1.116|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in Cmax||1.116|1.028|
73848467|NCT03571971|147242692|SUPERIORITY|Based on published data, we conservatively estimated that the standard exercise (SE) group and load modification (LM) group would have a 20% and 50% treatment success rate, respectively. We defined treatment success as either: 1) at least 'moderately better' on the Global Rating of Change scale or 2) ≥2 point decrease on the Numeric Pain Rating Scale. With one-side type I error=0.1, power=80%, and allocation ratio is 1:1, we estimated the need for 22 participants in each group (total N=44).|Odds Ratio (OR)|1.09||||0.879|TWO_SIDED|95.0|0.36|3.35||The a priori threshold for statistical significance was set at 0.05.|Chi-squared|||||3.35|0.36|0.879
73848468|NCT00553410|147242711|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.31|TWO_SIDED|95.0|0.93|1.26|||Log Rank|||||1.26|.93|.31
73848469|NCT00553410|147242712|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.16|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||||1.06|.68|.16
73848470|NCT00553410|147242713|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.25|TWO_SIDED|95.0|0.71|1.09|||Log Rank|||||1.09|.71|.25
73848471|NCT00553410|147242714|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.84|TWO_SIDED|95.0|0.81|1.18|||Log Rank|||||1.18|.81|.84
73848472|NCT00038948|147242715|SUPERIORITY_OR_OTHER||Weighted difference|-2.68||||0.575||95.0|-12.27|6.91||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of 20.0 to 40.0 mL/min||6.91|-12.27|0.575
73848473|NCT00038948|147242715|SUPERIORITY_OR_OTHER||Weighted difference|1.31||||0.278||95.0|-1.06|3.69||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of \>40.0 mL/min||3.69|-1.06|0.278
73848474|NCT00038948|147242716|SUPERIORITY_OR_OTHER|||||||0.135||||||Tests the equality of rates between treatments across strata at 52 weeks.|Cochran-Mantel-Haenszel|||52 weeks statistical analysis across strata||||0.135
73848475|NCT00038948|147242716|SUPERIORITY_OR_OTHER|||||||0.559||||||Tests the equality of rates between treatments across strata at 104 weeks.|Cochran-Mantel-Haenszel|||104 weeks statistical analysis across strata||||0.559
73848476|NCT02722408|147242717|OTHER|||||||0.0041||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0041
73848477|NCT02722408|147242718|OTHER|||||||0.001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0010
73848478|NCT02722408|147242719|OTHER|||||||0.0012||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0012
73848479|NCT02722408|147242720|OTHER|||||||0.056||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0560
73848480|NCT02722408|147242720|OTHER|||||||0.0219||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0219
73848481|NCT02722408|147242720|OTHER|||||||0.0286||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0286
73848482|NCT02722408|147242721|OTHER|||||||0.0058||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0058
73848483|NCT02722408|147242721|OTHER|||||||0.0019||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0019
73848484|NCT02722408|147242721|OTHER|||||||0.0024||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0024
73848485|NCT02722408|147242722|OTHER|||||||0.0592||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0592
73848486|NCT02722408|147242722|OTHER|||||||0.0266||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0266
73848487|NCT02722408|147242722|OTHER|||||||0.0336||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0336
73848488|NCT02722408|147242723|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
73848489|NCT02722408|147242723|OTHER|||||||0.0017||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0017
73848490|NCT02722408|147242723|OTHER|||||||0.0017||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0017
73848491|NCT02722408|147242724|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
73848492|NCT02722408|147242724|OTHER|||||||0.0255||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0255
73848493|NCT02722408|147242724|OTHER|||||||0.0312||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 86||||0.0312
73848494|NCT02722408|147242725|OTHER|||||||0.4489||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4489
73848495|NCT02722408|147242725|OTHER|||||||0.5964||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 84||||0.5964
74023475|NCT00432809|147599879|SUPERIORITY_OR_OTHER|||||||1.001||95.0|||||Chi-squared|||||||1.001
74023476|NCT00432809|147599879|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Chi-squared|||||||0.68
74023477|NCT00432809|147599880|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73848496|NCT02722408|147242725|OTHER|||||||0.6785||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.6785
73848497|NCT02722408|147242726|OTHER|||||||0.2177||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.2177
73848498|NCT02722408|147242726|OTHER|||||||0.3209||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.3209
73848499|NCT02722408|147242726|OTHER|||||||0.3101||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.3101
73848500|NCT02722408|147242727|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
73848501|NCT02722408|147242727|OTHER|||||||0.0022||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0022
73848502|NCT02722408|147242727|OTHER|||||||0.0029||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0029
73848503|NCT02722408|147242728|OTHER|||||||0.0008||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.0008
73848504|NCT02722408|147242728|OTHER|||||||0.0005||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.0005
73848505|NCT02722408|147242728|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.0002
73848506|NCT02722408|147242729|OTHER|||||||0.4103||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4103
73848507|NCT02722408|147242729|OTHER|||||||0.6164||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.6164
73848508|NCT02722408|147242729|OTHER|||||||0.6732||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.6732
73848509|NCT02722408|147242730|OTHER|||||||0.2003||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.2003
73848510|NCT02722408|147242730|OTHER|||||||0.3323||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.3323
73848511|NCT02722408|147242730|OTHER|||||||0.3047||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.3047
73848512|NCT02722408|147242731|OTHER|||||||0.3601||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3601
73848513|NCT02722408|147242731|OTHER|||||||0.192||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1920
73848514|NCT02722408|147242731|OTHER|||||||0.2912||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2912
73900229|NCT02446743|147331798|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-15.0|4.5||Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||4.5|-15.0|
73960688|NCT03034915|147456917|OTHER||Mean Difference (Net)|-1.94|STANDARD_ERROR_OF_MEAN|0.678||0.004|TWO_SIDED|95.0|-3.27|-0.61|||mixed model repeated measure||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||-0.61|-3.27|0.004
74023478|NCT00432809|147599880|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74023479|NCT00432809|147599880|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
74023480|NCT00432809|147599881|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74023481|NCT00432809|147599881|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73900230|NCT02446743|147331798|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-17.0|11.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.4|-17.0|
73900231|NCT02446743|147331798|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-8.0|||||TWO_SIDED|95.0|-20.0|7.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||7.3|-20.0|
73900232|NCT02446743|147331798|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||6.2|-0.9|
73900233|NCT02446743|147331798|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
73900234|NCT02446743|147331798|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
73900235|NCT02446743|147331798|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1(V72\_41) (1 month after booster or 2nd dose)|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
73900236|NCT02446743|147331798|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.3|7.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-2.3|
73900237|NCT02446743|147331798|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|4.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.1|-0.9|
73900238|NCT02446743|147331798|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|Vaccine group difference|-20.0|||||TWO_SIDED|95.0|-35.2|-7.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-7.5|-35.2|
73900239|NCT02446743|147331798|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-32.0|||||TWO_SIDED|95.0|-46.5|-15.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-15.7|-46.5|
73900240|NCT02446743|147331798|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Vaccine group difference|-28.0|||||TWO_SIDED|95.0|-38.4|-17.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-17.1|-38.4|
73900241|NCT02446743|147331798|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|9.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.2|-19.2|
73960689|NCT03034915|147456918|OTHER||Odds Ratio (OR)|1.21||||0.063|TWO_SIDED|95.0|0.99|1.48|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.|||1.48|0.99|0.063
73960690|NCT03034915|147456918|OTHER||Odds Ratio (OR)|1.49|||<|0.001|TWO_SIDED|95.0|1.22|1.83|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.|||1.83|1.22|<0.001
73960691|NCT03034915|147456918|OTHER||Odds Ratio (OR)|1.23||||0.045|TWO_SIDED|95.0|1.0|1.51|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.51|1.00|0.045
74023482|NCT00432809|147599881|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
74023483|NCT00432809|147599882|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74023484|NCT00432809|147599882|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Chi-squared|||||||0.005
74023485|NCT00432809|147599882|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
74023486|NCT00432809|147599883|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74023487|NCT00432809|147599883|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
73848515|NCT02722408|147242731|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||<0.0001
73848516|NCT02722408|147242731|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||<0.0001
73848517|NCT02722408|147242731|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
73848518|NCT02722408|147242731|OTHER|||||||0.0444||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0444
73848519|NCT02722408|147242731|OTHER|||||||0.0159||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0159
73848520|NCT02722408|147242731|OTHER|||||||0.0235||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0235
73900242|NCT02446743|147331798|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-14.1|12.3|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||12.3|-14.1|
73900243|NCT02446743|147331798|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|Vaccine group difference|-5.0|||||TWO_SIDED|95.0|-13.6|5.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||5.6|-13.6|
73848521|NCT02722408|147242731|OTHER|||||||0.0005||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0005
73848522|NCT02722408|147242731|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
73900244|NCT02446743|147331798|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Vaccine group difference|12.0|||||TWO_SIDED|95.0|3.6|21.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||21.6|3.6|
73900245|NCT02446743|147331798|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|6.4|24.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.6|6.4|
73848523|NCT02722408|147242731|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
73848524|NCT02722408|147242732|OTHER|||||||0.3646||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3646
73848525|NCT02722408|147242732|OTHER|||||||0.1994||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1994
73848526|NCT02722408|147242732|OTHER|||||||0.2858||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2858
73848527|NCT02722408|147242732|OTHER|||||||0.0829||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0829
73848528|NCT02722408|147242732|OTHER|||||||0.0492||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0492
73848529|NCT02722408|147242732|OTHER|||||||0.0442||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0442
73848530|NCT02722408|147242732|OTHER|||||||0.736||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.7360
73960692|NCT03034915|147456919|OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.891|TWO_SIDED|95.0|-0.6|0.6|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.6|-0.6|0.891
73848531|NCT02722408|147242732|OTHER|||||||0.6917||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.6917
73848532|NCT02722408|147242732|OTHER|||||||0.7131||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.7131
73848533|NCT02722408|147242732|OTHER|||||||0.0014||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0014
73848534|NCT02722408|147242732|OTHER|||||||0.0009||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0009
73848535|NCT02722408|147242732|OTHER|||||||0.0007||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0007
73900246|NCT02446743|147331798|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|Vaccine group difference|14.0|||||TWO_SIDED|95.0|7.6|20.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||20.3|7.6|
73900247|NCT02446743|147331799|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-44.0|||||TWO_SIDED|95.0|-52.7|-33.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-33.1|-52.7|
73900248|NCT02446743|147331799|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-3.9|3.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.6|-3.9|
73960693|NCT03034915|147456919|OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.074|TWO_SIDED|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.1|-1.1|0.074
73960694|NCT03034915|147456919|OTHER||Odds Ratio (OR)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.107|TWO_SIDED|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||0.1|-1.1|0.107
73848536|NCT02722408|147242733|OTHER|||||||0.388||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3880
73848537|NCT02722408|147242733|OTHER|||||||0.2057||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2057
73848538|NCT02722408|147242733|OTHER|||||||0.2892||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2892
73848539|NCT02722408|147242733|OTHER|||||||0.0052||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0052
73848540|NCT02722408|147242733|OTHER|||||||0.0028||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.0028
73848541|NCT02722408|147242733|OTHER|||||||0.0026||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.0026
73848542|NCT02722408|147242733|OTHER|||||||0.0493||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0493
73848543|NCT02722408|147242733|OTHER|||||||0.0253||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0253
73848544|NCT02722408|147242733|OTHER|||||||0.0394||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0394
73848545|NCT02722408|147242733|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
74023488|NCT00432809|147599883|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared|||||||0.20
74023489|NCT00432809|147599884|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74023490|NCT00432809|147599884|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74023491|NCT00432809|147599884|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared|||||||0.20
73848546|NCT02722408|147242733|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
73848547|NCT02722408|147242733|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
73848548|NCT02722408|147242734|OTHER|||||||0.3833||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3833
73848549|NCT02722408|147242734|OTHER|||||||0.2172||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2172
73848550|NCT02722408|147242734|OTHER|||||||0.293||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2930
73848551|NCT02722408|147242734|OTHER|||||||0.1217||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.1217
73848552|NCT02722408|147242734|OTHER|||||||0.0901||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0901
73848553|NCT02722408|147242734|OTHER|||||||0.085||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0850
73848554|NCT02722408|147242734|OTHER|||||||0.0747||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0747
73848555|NCT02722408|147242734|OTHER|||||||0.0279||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0279
73960695|NCT03034915|147456920|OTHER||Odds Ratio (OR)|1.35||||0.003|TWO_SIDED|95.0|1.11|1.65|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.|||1.65|1.11|0.003
73960696|NCT03034915|147456920|OTHER||Odds Ratio (OR)|1.23||||0.037|TWO_SIDED|95.0|1.01|1.5|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.|||1.50|1.01|0.037
73848556|NCT02722408|147242734|OTHER|||||||0.0492||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0492
73848557|NCT02722408|147242734|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
74023492|NCT00432809|147599885|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Chi-squared|||||||0.48
74023493|NCT00432809|147599885|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Chi-squared|||||||0.46
74023494|NCT00432809|147599885|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
74023495|NCT00432809|147599886|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74023496|NCT00432809|147599886|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74023497|NCT00432809|147599886|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Chi-squared|||||||0.62
74023498|NCT00432809|147599887|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74023499|NCT00432809|147599887|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74023500|NCT00432809|147599887|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Chi-squared|||||||0.03
74023501|NCT00707577|147599893|SUPERIORITY||||||<|0.05|||||||Regression, Linear|random effects regression models for panel data adjusted for clustering within team||||||<0.05
74023502|NCT00805207|147599917|OTHER|||||||0.85|||||||t-test, 2 sided|||||||0.85
74023503|NCT00805207|147599917|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
74023504|NCT00805207|147599917|OTHER|||||||0.88||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.88
74023505|NCT00805207|147599917|OTHER|||||||0.26||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.26
74023506|NCT00805207|147599917|OTHER|||||||0.98||||||P value is the group by treatment interaction from the ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.98
74023507|NCT00805207|147599918|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
74023508|NCT00805207|147599918|OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
74023509|NCT00805207|147599918|OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
74023510|NCT00805207|147599918|OTHER|||||||0.87|||||||ANCOVA|||||||0.87
73960697|NCT03034915|147456920|OTHER||Odds Ratio (OR)|0.91||||0.363|TWO_SIDED|95.0|0.75|1.11|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.11|0.75|0.363
73848558|NCT02722408|147242734|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
73960698|NCT01188499|147456922|SUPERIORITY_OR_OTHER||Percent|100.0|||||TWO_SIDED||||||||Primary objective of safety and tolerability measured by percent participants experiencing at least one adverse event. No formal statistics performed.|||||
73960699|NCT01188499|147456923|SUPERIORITY_OR_OTHER||Percent|10.0|||||TWO_SIDED||||||||Percent patients overall across all five arms demonstrating complete or partial response by RECIST. No formal statistics performed.|||||
73960700|NCT00424762|147456925|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||powered to detect at least 33% difference between groups||||>0.05
74023511|NCT00805207|147599918|OTHER|||||||0.57|||||||ANCOVA|||||||0.57
74023512|NCT00805207|147599919|OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
74023513|NCT00805207|147599919|OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
74023514|NCT00805207|147599919|OTHER|||||||0.53|||||||ANCOVA|||||||0.53
73848559|NCT02722408|147242734|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
73848560|NCT02722408|147242735|OTHER|||||||0.8972||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.8972
73848561|NCT02722408|147242735|OTHER|||||||0.7867||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7867
73848562|NCT02722408|147242735|OTHER|||||||0.4974||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.4974
73848563|NCT02722408|147242735|OTHER|||||||0.5464||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.5464
73848564|NCT02722408|147242735|OTHER|||||||0.7668||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.7668
73848565|NCT02722408|147242735|OTHER|||||||0.9276||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.9276
73848566|NCT02722408|147242735|OTHER|||||||0.5821||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.5821
73848567|NCT02722408|147242735|OTHER|||||||0.8881||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.8881
73848568|NCT02722408|147242735|OTHER|||||||0.8525||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.8525
73848569|NCT02722408|147242735|OTHER|||||||0.0112||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0112
73848570|NCT02722408|147242735|OTHER|||||||0.0018||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0018
73848571|NCT02722408|147242735|OTHER|||||||0.0028||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH).||||0.0028
73848572|NCT02722408|147242736|OTHER|||||||0.8985||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.8985
73848573|NCT02722408|147242736|OTHER|||||||0.7664||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7664
73848574|NCT02722408|147242736|OTHER|||||||0.4755||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.4755
73848575|NCT02722408|147242736|OTHER|||||||0.2286||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.2286
73848576|NCT02722408|147242736|OTHER|||||||0.3975||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.3975
73848577|NCT02722408|147242736|OTHER|||||||0.446||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.4460
73900249|NCT02446743|147331799|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-2.7|2.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||2.4|-2.7|
73900250|NCT02446743|147331799|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-46.0|||||TWO_SIDED|95.0|-58.4|-29.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-29.8|-58.4|
73848578|NCT02722408|147242736|OTHER|||||||0.9414||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9414
73900251|NCT02446743|147331799|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||TWO_SIDED|95.0|-7.7|5.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.1|-7.7|
73900252|NCT02446743|147331799|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.7|3.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.7|-5.7|
73900253|NCT02446743|147331799|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-40.0|||||TWO_SIDED|95.0|-51.8|-25.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-25.4|-51.8|
73900254|NCT02446743|147331799|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.3|9.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.0|-3.3|
73900255|NCT02446743|147331799|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.4|5.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-2.4|
73900256|NCT02446743|147331799|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-12.4|5.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.8|-12.4|
73900257|NCT02446743|147331799|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.2|7.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.7|-2.2|
73900258|NCT02446743|147331799|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||TWO_SIDED|95.0|2.8|10.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.5|2.8|
73900259|NCT02446743|147331799|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-17.8|10.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.6|-17.8|
73960701|NCT00424762|147456926|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||powered to detect difference of at least 10% between groups||||0.26
73960702|NCT00424762|147456927|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Chi-squared|||comparative incidence||||0.03
73848579|NCT02722408|147242736|OTHER|||||||0.9735||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.9735
73900260|NCT02446743|147331799|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.2|13.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.0|-3.2|
73848580|NCT02722408|147242736|OTHER|||||||0.9825||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.9825
73848581|NCT02722408|147242736|OTHER|||||||0.442||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.4420
73848582|NCT02722408|147242736|OTHER|||||||0.0378||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0378
73848583|NCT02722408|147242736|OTHER|||||||0.0378||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0378
73848584|NCT02722408|147242737|OTHER|||||||0.2305||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.2305
73848585|NCT02722408|147242737|OTHER|||||||0.1836||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1836
73848586|NCT02722408|147242737|OTHER|||||||0.6501||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.6501
73848587|NCT02722408|147242737|OTHER|||||||0.0139||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0139
73848588|NCT02722408|147242737|OTHER|||||||0.0077||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0077
73900261|NCT02446743|147331799|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|9.0|||||TWO_SIDED|95.0|3.7|16.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.5|3.7|
73848589|NCT02722408|147242737|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
73848590|NCT02722408|147242737|OTHER|||||||0.0507||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0507
73848591|NCT02722408|147242737|OTHER|||||||0.0118||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0118
73848592|NCT02722408|147242737|OTHER|||||||0.0122||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0122
73848593|NCT02722408|147242737|OTHER|||||||0.0077||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0077
73848594|NCT02722408|147242737|OTHER|||||||0.0317||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0317
73848595|NCT02722408|147242737|OTHER|||||||0.0473||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH).||||0.0473
73848596|NCT02722408|147242738|OTHER|||||||0.2143||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.2143
74023515|NCT00805207|147599919|OTHER|||||||0.23|||||||ANCOVA|||||||0.23
74023516|NCT00805207|147599920|OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
74023517|NCT00805207|147599921|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74023518|NCT00805207|147599921|OTHER||||||<|0.01||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA|||||||<0.01
73960703|NCT03557658|147456928|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate|106.22|||||TWO_SIDED|90.0|78.34|144.02|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for total bexagliflozin by hepatic function group.||144.02|78.34|
73960704|NCT03557658|147456928|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|110.84|||||TWO_SIDED|90.0|75.34|163.06|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for unbound bexagliflozin by hepatic function group||163.06|75.34|
74084721|NCT03653026|147722714|SUPERIORITY||Adjusted Response Rate Difference|15.9|||<|0.001|TWO_SIDED|95.0|11.4|20.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||20.3|11.4|<0.001
73848597|NCT02722408|147242738|OTHER|||||||0.1874||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1874
73848598|NCT02722408|147242738|OTHER|||||||0.6731||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.6731
73960705|NCT03557658|147456931|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|128.34|||||TWO_SIDED|90.0|99.98|164.73|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for total bexagliflozin by hepatic function group||164.73|99.98|
73848599|NCT02722408|147242738|OTHER|||||||0.0027||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0027
73848600|NCT02722408|147242738|OTHER|||||||0.002||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0020
73848601|NCT02722408|147242738|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
73848602|NCT02722408|147242738|OTHER|||||||0.0258||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0258
73848603|NCT02722408|147242738|OTHER|||||||0.0044||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0044
73848604|NCT02722408|147242738|OTHER|||||||0.0011||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0011
73848605|NCT02722408|147242738|OTHER|||||||0.0083||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0083
73848606|NCT02722408|147242738|OTHER|||||||0.0314||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0314
73848607|NCT02722408|147242738|OTHER|||||||0.0533||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0533
73848608|NCT02722408|147242739|OTHER|||||||0.3657||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3657
73848609|NCT02722408|147242739|OTHER|||||||0.1983||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1983
73848610|NCT02722408|147242739|OTHER|||||||0.297||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2970
73848611|NCT02722408|147242739|OTHER|||||||0.0092||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0092
73848612|NCT02722408|147242739|OTHER|||||||0.0049||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0049
73900262|NCT02446743|147331799|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||TWO_SIDED|95.0|-11.8|11.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.0|-11.8|
73900263|NCT02446743|147331799|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-4.6|10.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.1|-4.6|
73900264|NCT02446743|147331799|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|-0.8|9.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.5|-0.8|
73900265|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-45.0|||||TWO_SIDED|95.0|-54.4|-34.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-34.3|-54.4|
73900266|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.5|5.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.2|-4.5|
73900267|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.9|3.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.9|-1.9|
73900268|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-48.0|||||TWO_SIDED|95.0|-60.8|-32.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-32.0|-60.8|
73900269|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-7.3|10.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.1|-7.3|
73900270|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.7|3.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.7|-5.7|
73900271|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-41.0|||||TWO_SIDED|95.0|-53.3|-25.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-25.5|-53.3|
73900272|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.8|8.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.1|-4.8|
73900273|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-0.6|7.8|||Miettinen and Nurminen score methodx|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-0.6|
73900274|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-15.9|4.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.6|-15.9|
73900275|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.2|-0.9|
74023519|NCT00805207|147599921|OTHER|||||||0.96||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA|||||||0.96
74023520|NCT00805207|147599921|OTHER||||||<|0.05||||||P value is the group by treatment interaction from the ANOVA|ANOVA|||||||<0.05
74023521|NCT00805207|147599921|OTHER||||||<|0.01|||||||Tukey test|||||||<0.01
73900276|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|4.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.1|-0.9|
73900277|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|10.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.3|-19.2|
73900278|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
73900279|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
73900280|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.4|9.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.1|-19.4|
73900281|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
73900282|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.3|7.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-2.3|
73900283|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-26.0|||||TWO_SIDED|95.0|-36.6|-15.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||-15.7|-36.6|
73900284|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||TWO_SIDED|95.0|-13.3|8.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.5|-13.3|
73900285|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|21.0|||||TWO_SIDED|95.0|12.8|28.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.3|12.8|
73900286|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-18.0|||||TWO_SIDED|95.0|-32.5|-5.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-5.8|-32.5|
73900287|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-7.0|||||TWO_SIDED|95.0|-22.3|9.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.5|-22.3|
73900288|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|20.0|||||TWO_SIDED|95.0|8.4|31.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||31.3|8.4|
74023522|NCT00805207|147599921|OTHER||||||<|0.01|||||||Tukey test|||||||<0.01
74023523|NCT00805207|147599921|OTHER||||||>|0.1|||||||Tukey test|||||||>0.10
74023524|NCT00805207|147599921|OTHER||||||>|0.1|||||||Tukey test|||||||>0.10
74023525|NCT00064701|147599922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-1.9|||||TWO_SIDED|95.2|-8.9|5.2||||||||5.2|-8.9|
74023526|NCT00064701|147599922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.0|||||TWO_SIDED|95.2|-9.9|4.0||||||||4.0|-9.9|
74023527|NCT00064701|147599923|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.3|||||TWO_SIDED|95.0|-7.2|0.6||||||||0.6|-7.2|
73848613|NCT02722408|147242739|OTHER|||||||0.0033||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0033
74023528|NCT00064701|147599923|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||TWO_SIDED|95.0|-3.1|3.2||||||||3.2|-3.1|
73848614|NCT02722408|147242739|OTHER|||||||0.0618||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0618
73848615|NCT02722408|147242739|OTHER|||||||0.0298||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0298
73848616|NCT02722408|147242739|OTHER|||||||0.0352||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0352
73848617|NCT02722408|147242739|OTHER|||||||0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0001
73848618|NCT02722408|147242739|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
73848619|NCT02722408|147242739|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
73848620|NCT02722408|147242740|OTHER|||||||0.3672||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr||||0.3672
73900289|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||TWO_SIDED|95.0|-46.0|-15.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-15.5|-46.0|
73848621|NCT02722408|147242740|OTHER|||||||0.2101||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2101
73848622|NCT02722408|147242740|OTHER|||||||0.3009||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.3009
73848623|NCT02722408|147242740|OTHER|||||||0.1567||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.1567
73848624|NCT02722408|147242740|OTHER|||||||0.1207||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.1207
73848625|NCT02722408|147242740|OTHER|||||||0.1045||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.1045
73848626|NCT02722408|147242740|OTHER|||||||0.0631||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0631
73848627|NCT02722408|147242740|OTHER|||||||0.0217||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0217
73848628|NCT02722408|147242740|OTHER|||||||0.0359||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0359
73848629|NCT02722408|147242740|OTHER|||||||0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0001
73848630|NCT02722408|147242740|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
74023529|NCT00064701|147599924|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.8|||||TWO_SIDED|95.0|-8.5|0.9||||||||0.9|-8.5|
74023530|NCT00064701|147599924|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||TWO_SIDED|95.0|-4.0|4.1||||||||4.1|-4.0|
74023531|NCT00064701|147599925|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-8.0|||||TWO_SIDED|95.0|-13.1|-3.0||||||Comparison of tacrolimus with cyclosporine at 6 months||-3.0|-13.1|
74023532|NCT00064701|147599925|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-3.8|||||TWO_SIDED|95.0|-9.5|1.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 6 months||1.8|-9.5|
73848631|NCT02722408|147242740|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
73848632|NCT02722408|147242741|OTHER|||||||0.9417||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.9417
73848633|NCT02722408|147242741|OTHER|||||||0.7722||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7722
73848634|NCT02722408|147242741|OTHER|||||||0.5283||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.5283
73848635|NCT02722408|147242741|OTHER|||||||0.5905||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.5905
73848636|NCT02722408|147242741|OTHER|||||||0.7682||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.7682
73848637|NCT02722408|147242741|OTHER|||||||0.9245||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.9245
73848638|NCT02722408|147242741|OTHER|||||||0.6325||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.6325
73848639|NCT02722408|147242741|OTHER|||||||0.9221||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9221
73848640|NCT02722408|147242741|OTHER|||||||0.8387||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.8387
73848641|NCT02722408|147242741|OTHER|||||||0.0089||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0089
73848642|NCT02722408|147242741|OTHER|||||||0.0013||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0013
73848643|NCT02722408|147242741|OTHER|||||||0.0019||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0019
73848644|NCT02722408|147242742|OTHER|||||||0.9195||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.9195
73848645|NCT02722408|147242742|OTHER|||||||0.7497||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7497
73848646|NCT02722408|147242742|OTHER|||||||0.5056||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.5056
74023533|NCT00064701|147599925|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 Months|-6.1|||||TWO_SIDED|95.0|-12.0|-0.3||||||Comparison of tacrolimus with cyclosporine at 12 months||-0.3|-12.0|
74023534|NCT00064701|147599925|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 months|-3.4|||||TWO_SIDED|95.0|-9.6|2.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 12 months||2.8|-9.6|
74023535|NCT00064701|147599935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-6.5|5.5||||||||5.5|-6.5|
74023536|NCT00064701|147599935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-3.9|6.9||||||||6.9|-3.9|
74023537|NCT00064701|147599936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-9.1|6.6||||||||6.6|-9.1|
74023538|NCT00064701|147599936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-7.1|8.6||||||||8.6|-7.1|
74023539|NCT02249052|147599937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.33|STANDARD_DEVIATION|25.0311|<|0.0001|TWO_SIDED|95.0|-95.394|-71.265|||t-test, 2 sided|||||-71.265|-95.394|<0.0001
74023540|NCT02249052|147599938|SUPERIORITY_OR_OTHER||Binomial proportion|0.8947|||<|0.0001|TWO_SIDED|95.0|0.6686|0.987|||Sign test|||||.9870|.6686|<.0001
74023541|NCT02700451|147600005|EQUIVALENCE|Two-sided 95% confidence interval|||||<|0.001||||||Threshold for statistical significance was p = 0.05|Kruskal-Wallis|||The distribution of OME total in the first 72H is the same across these arms||||<0.001
73848647|NCT02722408|147242742|OTHER|||||||0.2468||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.2468
73848648|NCT02722408|147242742|OTHER|||||||0.392||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.3920
73848649|NCT02722408|147242742|OTHER|||||||0.4456||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.4456
73848650|NCT02722408|147242742|OTHER|||||||0.9203||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9203
73848651|NCT02722408|147242742|OTHER|||||||0.9704||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.9704
73848652|NCT02722408|147242742|OTHER|||||||0.9755||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.9755
73848653|NCT02722408|147242742|OTHER|||||||0.4213||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.4213
73848654|NCT02722408|147242742|OTHER|||||||0.03||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0300
73848655|NCT02722408|147242742|OTHER|||||||0.03||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0300
73900290|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-10.8|18.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||18.8|-10.8|
73848656|NCT02722408|147242748|OTHER|||||||0.0294||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.0294
73848657|NCT02722408|147242748|OTHER|||||||0.3228||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3228
73848658|NCT02722408|147242748|OTHER|||||||0.5268||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.5268
73848659|NCT02722408|147242749|OTHER|||||||0.1099||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1099
73848660|NCT02722408|147242749|OTHER|||||||0.5478||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.5478
73848661|NCT02722408|147242749|OTHER|||||||0.8837||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.8837
73848662|NCT02722408|147242750|OTHER|||||||0.0587||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0587
74023542|NCT02700451|147600005|EQUIVALENCE|Two-sided 95% confidence interval|||||<|0.001||||||The thresholds for statistical significant was p = 0.05|Kruskal-Wallis|||The distribution of OME total to discharge is the same across these arms||||<0.001
74023543|NCT02700451|147600006|EQUIVALENCE|Two-sided||||||0.048|||||||Chi-squared|||Similar Distribution of opioid use between the 3 arms||||0.048
74023544|NCT02700451|147600007|EQUIVALENCE|Two-sided||||||0.595|||||||Chi-squared|||||||0.595
74023545|NCT02700451|147600010|EQUIVALENCE|Two-sided 95% confidence interval||||||0.732|||||||Kruskal-Wallis|||The distribution of POD1 - Current pain level is the same across the 3 arms||||0.732
74023546|NCT02700451|147600010|EQUIVALENCE|Two-sided 95% confidence interval||||||0.896|||||||Kruskal-Wallis|||The distribution of POD1 - Best pain level is the same across the 3 arms||||0.896
74023547|NCT02700451|147600010|EQUIVALENCE|Two-sided 95% confidence interval||||||0.004|||||||Kruskal-Wallis|||The distribution of POD1 - Worst pain level is the same across the 3 arms||||0.004
73900291|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|22.0|||||TWO_SIDED|95.0|12.1|32.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.8|12.1|
73900292|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-13.4|7.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.1|-13.4|
73900293|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.2|8.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.5|-3.2|
73900294|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|4.2|13.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.2|4.2|
73900295|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-15.1|16.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||16.1|-15.1|
73900296|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-4.7|13.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.9|-4.7|
73900297|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|12.0|||||TWO_SIDED|95.0|5.9|20.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.9|5.9|
73900298|NCT02446743|147331800|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.7|8.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||8.6|-16.7|
73900299|NCT02446743|147331800|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-5.7|11.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.1|-5.7|
73900300|NCT02446743|147331800|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|5.0|||||TWO_SIDED|95.0|-0.7|11.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.1|-0.7|
73900301|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-30.0|||||TWO_SIDED|95.0|-40.4|-19.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-19.0|-40.4|
73900302|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-2.6|10.3|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.3|-2.6|
73900303|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|3.9|12.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.5|3.9|
73900304|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-27.0|||||TWO_SIDED|95.0|-41.8|-12.9|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-12.9|-41.8|
74023548|NCT02700451|147600010|EQUIVALENCE|Two-sided 95% confidence interval||||||0.325|||||||Kruskal-Wallis|||The distribution of POD3 - Current pain level is the same across the 3 arms||||0.325
74023549|NCT02700451|147600010|EQUIVALENCE|Two-sided 95% confidence interval||||||0.283|||||||Kruskal-Wallis|||The distribution of POD3 - Best pain level is the same across the 3 arms||||0.283
73900305|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-6.0|16.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.2|-6.0|
73900306|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|7.0|||||TWO_SIDED|95.0|1.4|15.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.2|1.4|
73900307|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||TWO_SIDED|95.0|-45.1|-14.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-14.6|-45.1|
73900308|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|1.9|13.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.5|1.9|
73900309|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|4.4|15.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.0|4.4|
73900310|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.0|6.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.5|-16.0|
73900311|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.2|-0.9|
73960706|NCT03557658|147456931|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|132.16|||||TWO_SIDED|90.0|96.46|181.08|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for unbound bexagliflozin by hepatic function group||181.08|96.46|
73960707|NCT03401112|147456999|SUPERIORITY|||||||0.0686|||||||Log Rank|||||||0.0686
73960708|NCT03401112|147456999|SUPERIORITY|||||||0.0294|||||||Log Rank|||||||0.0294
73960709|NCT00392054|147457009|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.0016|TWO_SIDED|95.0|0.35|0.9||Cox regression analysis, stratified by clinical site, was performed and presented as hazard ratios with 95% confidence intervals and a two-sided p-value testing of less than or equal to 0.05 (two-sided) for the Wald test.|Regression, Cox|||Event rates were plotted over time using Kaplan-Meier methodology. Only events occurring after the 90-day treatment period were included in the final analysis. Treatment groups were analyzed on an intention-to-treat basis.||0.90|0.35|0.0016
73960710|NCT00392054|147457011|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.03|TWO_SIDED|95.0|0.33|0.95|||Regression, Cox|||||0.95|0.33|0.03
73960711|NCT00392054|147457012|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52||||0.017|TWO_SIDED|95.0|0.3|0.89|||Regression, Cox|||||0.89|0.3|0.017
73960712|NCT00392054|147457013|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.28|0.4|||Regression, Cox|||||0.4|0.28|<0.0001
73960713|NCT00392054|147457014|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.66|TWO_SIDED|95.0|0.42|1.72|||Regression, Cox|||||1.72|0.42|0.66
73960714|NCT04975308|147457017|SUPERIORITY||Hazard Ratio (HR)|0.867||||0.1158|TWO_SIDED|95.0|0.724|1.039|||Log Rank|||||1.039|0.724|0.1158
73960715|NCT04975308|147457018|SUPERIORITY||Hazard Ratio (HR)|0.569|||<|0.0001|TWO_SIDED|95.0|0.441|0.733|||Log Rank|||||0.733|0.441|<0.0001
73960716|NCT04975308|147457019|SUPERIORITY||Hazard Ratio (HR)|0.617||||0.0008|TWO_SIDED|95.0|0.464|0.821|||Log Rank|||||0.821|0.464|0.0008
73960717|NCT02709655|147457038|OTHER||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|1.24||0.0937|TWO_SIDED|95.0|-4.54|0.36|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.36|-4.54|0.0937
73960718|NCT02709655|147457038|OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|1.44||0.2336|TWO_SIDED|95.0|-4.56|1.11|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||1.11|-4.56|0.2336
73960719|NCT02709655|147457038|OTHER||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|1.44||0.0879|TWO_SIDED|95.0|-5.29|0.37|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.37|-5.29|0.0879
73900312|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-0.33|5.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-0.33|
73900313|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-20.5|10.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.6|-20.5|
73900314|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
73900315|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
73900316|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-19.4|13.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||13.0|-19.4|
73900317|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
73900318|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.2|9.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.4|-1.2|
73900319|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-20.0|||||TWO_SIDED|95.0|-30.0|-11.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-11.1|-30.0|
73900320|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|-7.6|15.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.7|-7.6|
73900321|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|32.0|||||TWO_SIDED|95.0|23.2|40.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||40.2|23.2|
73900322|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-13.0|||||TWO_SIDED|95.0|-25.9|-3.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-3.0|-25.9|
73900323|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-17.1|15.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.9|-17.1|
73900324|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||TWO_SIDED|95.0|20.5|45.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||45.3|20.5|
73900325|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-25.0|||||TWO_SIDED|95.0|-40.1|-11.2|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-11.2|-40.1|
74023550|NCT02700451|147600010|EQUIVALENCE|Two-sided 95% confidence interval||||||0.61|||||||Kruskal-Wallis|||The distribution of POD3 - Worst pain level is the same across the 3 arms||||0.610
74023551|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.016|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with General Activity is the same across the 3 arms||||0.016
73900326|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|12.0|||||TWO_SIDED|95.0|-3.9|28.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.1|-3.9|
73900327|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||TWO_SIDED|95.0|22.0|44.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||44.1|22.0|
73900328|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.0|6.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.0|-16.0|
73900329|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-6.8|8.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.9|-6.8|
73900330|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|11.0|||||TWO_SIDED|95.0|5.3|16.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.9|5.3|
73900331|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||TWO_SIDED|95.0|-18.0|14.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.1|-18.0|
73900332|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-9.7|15.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.7|-9.7|
73900333|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|17.0|||||TWO_SIDED|95.0|8.2|27.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||27.8|8.2|
73900334|NCT02446743|147331801|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.1|9.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.1|-19.1|
73900335|NCT02446743|147331801|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.4|11.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.8|-8.4|
73900336|NCT02446743|147331801|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||TWO_SIDED|95.0|-0.47|12.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.6|-0.47|
73900337|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|3.49|||||TWO_SIDED|95.0|2.85|4.29|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.29|2.85|
73960720|NCT02709655|147457038|OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.7||0.0531|TWO_SIDED|95.0|-6.65|0.04|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.04|-6.65|0.0531
73960721|NCT02248480|147457089|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
74023552|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.294|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Mood is the same across the 3 arms||||0.294
74023553|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.016|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Walking Ability is the same across the 3 arms||||0.016
74023554|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.082|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Normal work is the same across the 3 arms||||0.082
73900338|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.73|||||TWO_SIDED|95.0|2.02|3.69|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.69|2.02|
73900339|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|4.46|||||TWO_SIDED|95.0|3.38|5.88|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||5.88|3.38|
73900340|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|8.18|||||TWO_SIDED|95.0|6.51|10.0|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||10|6.51|
73900341|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|9.58|||||TWO_SIDED|95.0|7.17|13.0|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||13|7.17|
73900342|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|6.9|||||TWO_SIDED|95.0|4.82|9.87|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||9.87|4.82|
73900343|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|2.58|||||TWO_SIDED|95.0|1.98|3.36|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.36|1.98|
73900344|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.65|||||TWO_SIDED|95.0|1.89|3.73|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.73|1.89|
73900345|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|2.51|||||TWO_SIDED|95.0|1.67|3.78|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.78|1.67|
73900346|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|1.9|||||TWO_SIDED|95.0|1.52|2.36|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.36|1.52|
73900347|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|1.88|||||TWO_SIDED|95.0|1.37|2.59|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.59|1.37|
73900348|NCT02446743|147331802|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|1.91|||||TWO_SIDED|95.0|1.41|2.58|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.58|1.41|
73900349|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-7.5|1.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||1.8|-7.5|
73960722|NCT01579916|147457156|NON_INFERIORITY_OR_EQUIVALENCE|H0 (null): Rate difference greater than or equal to 5 percentage points. This corresponds to a null hypothesis of: HA (alternative): rate difference \< 5 percentage points.|Rate difference|-1.7|||||TWO_SIDED|95.0|-8.9|0.6|||Score statistic|||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (trivalent influenza virus vaccine minus placebo) evaluated against the prespecified equivalence criterion of 5 percentage points||0.6|-8.9|
73960723|NCT00385801|147457175|SUPERIORITY_OR_OTHER|||||||0.86||||||The effect of treatment on intensity of craving was assessed and the threshold for statistical significance was p \< 0.05|Mixed Models Analysis|F=0.03||Intensity of craving||||0.86
73960724|NCT01359371|147457193|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||Bivariate relationships between a patient's participation in the program and smoking status were calculated.||||<.01
73848663|NCT02722408|147242750|OTHER|||||||0.1491||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.1491
73848664|NCT02722408|147242750|OTHER|||||||0.2224||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2224
73900350|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|53.0|||||TWO_SIDED|95.0|42.1|62.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||62.5|42.1|
73900351|NCT02446743|147331804|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|58.0|||||TWO_SIDED|95.0|50.5|64.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||64.7|50.5|
73900352|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-14.1|2.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||2.0|-14.1|
73900353|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|44.0|||||TWO_SIDED|95.0|28.1|58.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.5|28.1|
73900354|NCT02446743|147331804|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|44.0|||||TWO_SIDED|95.0|32.7|54.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||54.1|32.7|
73900355|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.0|4.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.8|-8.0|
73900356|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|60.0|||||TWO_SIDED|95.0|45.0|71.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||71.5|45.0|
73900357|NCT02446743|147331804|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|71.0|||||TWO_SIDED|95.0|61.2|78.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||78.5|61.2|
73900358|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-9.1|4.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||4|-9.1|
73900359|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|37.0|||||TWO_SIDED|95.0|27.0|48.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||48.1|27.0|
73900360|NCT02446743|147331804|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|33.0|||||TWO_SIDED|95.0|25.2|40.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||40.4|25.2|
73960725|NCT01359371|147457194|OTHER|T-tests, chi squares and Fishers exact tests were used to compare groups.|||||<|0.05||||||This was just a sample description, so there was not adjustment for multiple comparisons.|Chi-squared||||T-tests, chi squares and Fishers exact tests were used to compare groups.|||<.05
73960726|NCT01359371|147457194|OTHER||||||<|0.05|||||||Chi-squared|||T-tests, chi squares and Fishers exact tests were used to compare groups.||||<.05
73848665|NCT02722408|147242751|OTHER|||||||0.0959||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0959
73848666|NCT02722408|147242751|OTHER|||||||0.0923||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0923
73960727|NCT05328297|147457222|SUPERIORITY||Least Square Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.96|=|0.438|TWO_SIDED|80.0|-2.84|2.23|||Mixed Model for Repeated Measures (MMRM)|||||2.23|-2.84|=0.438
74023555|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.117|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Relation with other is the same across the 3 arms||||0.117
74084722|NCT03653026|147722715|SUPERIORITY||Adjusted Response Rate Difference|49.4|||<|0.001|TWO_SIDED|95.0|41.7|57.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||57.1|41.7|<0.001
73848667|NCT02722408|147242751|OTHER|||||||0.1592||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.1592
73848668|NCT02722408|147242752|OTHER|||||||0.5856||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.5856
73848669|NCT02722408|147242752|OTHER|||||||0.644||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.6440
73848670|NCT02722408|147242752|OTHER|||||||0.2269||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2269
73900361|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|2.0|||||TWO_SIDED|95.0|-8.7|10.2|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.2|-8.7|
73900362|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|43.0|||||TWO_SIDED|95.0|27.7|58.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.6|27.7|
73900363|NCT02446743|147331804|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|42.0|||||TWO_SIDED|95.0|31.1|53.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||53.0|31.1|
73900364|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|0.9|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||0.9|-19.2|
73900365|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|32.0|||||TWO_SIDED|95.0|18.2|47.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||47.0|18.2|
73900366|NCT02446743|147331804|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|24.0|||||TWO_SIDED|95.0|13.2|34.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||34.4|13.2|
73900367|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.7|3.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.4|-4.7|
73848671|NCT02722408|147242753|OTHER|||||||0.4814||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4814
73848672|NCT02722408|147242753|OTHER|||||||0.5011||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.5011
73848673|NCT02722408|147242753|OTHER|||||||0.4356||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.4356
74023556|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.061|||||||Fisher Exact|||The distribution of POD1 - Pain has interfered with Sleep is the same across the 3 arms||||0.061
74023557|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.023|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Enjoyment of life is the same across the 3 arms||||0.023
74023558|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.681|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with General Activity is the same across the 3 arms||||0.681
74023559|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.405|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Mood is the same across the 3 arms||||0.405
73960728|NCT02544152|147457269|OTHER||||||=|0.987|||||||Cochran-Mantel-Haenszel|||P-value is from a Cochran-Mantel-Haenszel (CMH) test stratified by sex and baseline stool consistency||||=0.9870
73900368|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|36.0|||||TWO_SIDED|95.0|25.6|45.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||45.7|25.6|
73900369|NCT02446743|147331804|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|54.0|||||TWO_SIDED|95.0|45.2|61.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||61.1|45.2|
73900370|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.4|5.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-8.4|
73900371|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|29.0|||||TWO_SIDED|95.0|12.1|43.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||43.0|12.1|
73960729|NCT00516321|147457282|SUPERIORITY_OR_OTHER||Percentage difference in SVR|7.9||||0.0064|TWO_SIDED|95.0|2.4|13.4||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.|||13.4|2.4|0.0064
73960730|NCT04303156|147457325|OTHER||GMR|2.2|||||TWO_SIDED|90.0|1.68|2.88|||||Severe Renal Impairment / Healthy|Geometric mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.88|1.68|
73960731|NCT04303156|147457326|OTHER||GMR|1.93|||||TWO_SIDED|90.0|1.46|2.55|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.55|1.46|
73960732|NCT04303156|147457327|OTHER||GMR|1.03|||||TWO_SIDED|90.0|0.67|1.57|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.57|0.67|
73960733|NCT04303156|147457330|OTHER||GMR|0.46|||||TWO_SIDED|90.0|0.35|0.6|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.60|0.35|
74023560|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.458|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Walking Ability is the same across the 3 arms||||0.458
73900372|NCT02446743|147331804|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|46.0|||||TWO_SIDED|95.0|33.6|57.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/154 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||57.1|33.6|
73900373|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.0|5.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.4|-8.0|
73960734|NCT04303156|147457331|OTHER||GMR|0.8|||||TWO_SIDED|90.0|0.56|1.14|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.14|0.56|
73960735|NCT04303156|147457332|OTHER||GMR|1.48|||||TWO_SIDED|90.0|1.03|2.14|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.14|1.03|
73960736|NCT04303156|147457333|OTHER||GMR|1.38|||||TWO_SIDED|90.0|0.98|1.93|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.93|0.98|
73960737|NCT04303156|147457334|OTHER||GMR|0.94|||||TWO_SIDED|90.0|0.64|1.39|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.39|0.64|
73960738|NCT04303156|147457336|OTHER||GMR|0.97|||||TWO_SIDED|90.0|0.69|1.35|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.35|0.69|
73960739|NCT04303156|147457337|OTHER||GMR|1.82|||||TWO_SIDED|90.0|0.55|6.02|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|6.02|0.55|
73960740|NCT04303156|147457338|OTHER||GMR|2.69|||||TWO_SIDED|90.0|1.51|4.8|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|4.80|1.51|
73960741|NCT04283552|147457345|SUPERIORITY|||||||0.001|||||||Two-tailed Wildoxon signed-rank test|||This statistical analysis is for Reader 1.||||0.001
74023561|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.482|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Normal work is the same across the 3 arms||||0.482
73900374|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|42.0|||||TWO_SIDED|95.0|27.8|54.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||54.5|27.8|
73900375|NCT02446743|147331804|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|60.0|||||TWO_SIDED|95.0|47.9|69.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||69.6|47.9|
73900376|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.1|5.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.4|-1.1|
73900377|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|28.0|||||TWO_SIDED|95.0|19.1|34.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||34.9|19.1|
73900378|NCT02446743|147331804|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|39.0|||||TWO_SIDED|95.0|31.6|46.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||46.6|31.6|
73900379|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-4.9|6.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.7|-4.9|
73900380|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|25.0|||||TWO_SIDED|95.0|9.7|37.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||37.1|9.7|
73900381|NCT02446743|147331804|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|37.0|||||TWO_SIDED|95.0|25.1|47.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||47.0|25.1|
73900382|NCT02446743|147331804|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-3.9|7.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.6|-3.9|
73900383|NCT02446743|147331804|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|28.0|||||TWO_SIDED|95.0|20.2|36.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||36.6|20.2|
73960742|NCT04283552|147457345|SUPERIORITY|||||||0.28|||||||Two-tailed Wilcoxon signed-rank test|||This statistical analysis is for Reader 2.||||0.28
73960743|NCT04283552|147457346|SUPERIORITY|||||||0.22|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||0.22
73960744|NCT04283552|147457346|SUPERIORITY||||||>|0.05|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||>0.05
73960745|NCT04283552|147457347|SUPERIORITY|||||||0.009|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||0.009
73960746|NCT04283552|147457347|SUPERIORITY||||||>|0.05|||||||Two-tailed Wilcoxon signed-rank test.|||This statistical analysis is for Reader 2.||||>0.05
73960747|NCT04283552|147457348|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||<0.001
73960748|NCT04283552|147457348|SUPERIORITY|||||||0.02|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||0.02
73960749|NCT04283552|147457349|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||<0.001
73960750|NCT04283552|147457349|SUPERIORITY|||||||0.02|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||0.02
73960751|NCT04283552|147457352|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis comparing PS-Early Reader 1 to PS-Late Reader 1.||||<0.001
73960752|NCT04283552|147457352|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis comparing PS-Early Reader 2 and PS-Late Reader 2.||||<0.001
73960753|NCT01240330|147457366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.9|STANDARD_DEVIATION|7.46|<|0.0001|TWO_SIDED|95.0|16.3|21.59|||t-test, 1 sided|||The femoral venous peak flow velocity (PFV) compared to the subject's own resting baseline PFV.||21.59|16.30|<0.0001
74023562|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.544|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Relation with other is the same across the 3 arms||||0.544
73900384|NCT02446743|147331804|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|42.0|||||TWO_SIDED|95.0|31.0|51.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||51.9|31.0|
73900385|NCT03718299|147331815|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Week 52||||<0.001
73900386|NCT03718299|147331816|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
73960754|NCT03260140|147457373|SUPERIORITY||Mean Difference (Final Values)|-1.93||||0.001|TWO_SIDED|97.5|-3.24|-0.61|||Mixed Models Analysis|Difference in average weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month weight between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||-0.61|-3.24|0.001
73960755|NCT03260140|147457374|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.388|TWO_SIDED|97.5|-1.11|2.49|||Mixed Models Analysis|Difference in average SF-12 PCS score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.49|-1.11|0.388
73960756|NCT03260140|147457375|SUPERIORITY||Sign test|1.76||||0.308|TWO_SIDED|95.0|0.85|3.66|||F test-ratio of 2 McNemar's Chi-Squares|||Group-specific McNemar's Chi-Square tests were applied to examine the change from baseline to follow-up in dichotomized IPAQ (\>=150 vs \<150) minutes of physical activity per week. To compare intervention vs. control at 12 months, we applied an F test. The intervention effect was an odds ratio of the ratios of discordant pairs in the intervention vs the control group.||3.66|0.85|0.308
73960757|NCT03260140|147457376|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.396|TWO_SIDED|95.0|-0.61|0.24|||Mixed Models Analysis|Difference in average weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.24|-0.61|0.396
73960758|NCT03260140|147457377|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.657|TWO_SIDED|95.0|-1.02|1.61|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.61|-1.02|0.657
73960759|NCT03260140|147457378|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.281|TWO_SIDED|95.0|-2.33|0.68|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.68|-2.33|0.281
73960760|NCT03260140|147457379|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.483|TWO_SIDED|95.0|-0.11|0.23|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rodgers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.23|-0.11|0.483
73960761|NCT03260140|147457380|SUPERIORITY||Mean percent change in HbA1c|0.02||||0.985|TWO_SIDED|95.0|-2.57|2.69|||Mixed Models Analysis|Difference in average HbA1c at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis on log-transformed HbA1c comparing the average HbA1c between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.69|-2.57|0.985
73900387|NCT03718299|147331817|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73900388|NCT03718299|147331818|SUPERIORITY||Clopper-Pearson|62.2|||||TWO_SIDED|95.0|46.5|76.2||||||||76.2|46.5|
73900389|NCT03718299|147331819|SUPERIORITY||Clopper-Pearson|93.3|||||TWO_SIDED|95.0|81.7|98.6||||||||98.6|81.7|
73900390|NCT03718299|147331820|SUPERIORITY||Clopper-Pearson|78.9|||||TWO_SIDED|95.0|62.7|90.4||||||||90.4|62.7|
73900391|NCT03718299|147331821|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73900392|NCT03718299|147331822|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73900393|NCT03718299|147331823|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73900394|NCT03718299|147331824|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73900395|NCT03718299|147331825|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73900396|NCT03718299|147331826|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73900397|NCT03718299|147331827|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73900398|NCT03718299|147331828|SUPERIORITY||Mean (Clopper-Pearson)|24.4|||||TWO_SIDED|95.0|12.9|39.5||||||||39.5|12.9|
73900399|NCT03718299|147331829|SUPERIORITY||Mean (Clopper-Pearson)|17.8|||||TWO_SIDED|95.0|8.0|32.1||||||||32.1|8.0|
73900400|NCT03718299|147331830|SUPERIORITY||Clopper-Pearson|48.9|||||TWO_SIDED|95.0|33.7|64.2||||||||64.2|33.7|
74023563|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.202|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Sleep is the same across the 3 arms||||0.202
73900401|NCT03718299|147331831|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Total Activity Impairment||||<0.001
73900402|NCT03718299|147331831|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Total Work Productivity Impairment||||<0.001
73900403|NCT03718299|147331832|SUPERIORITY||Mean|79.5|STANDARD_DEVIATION|20.06|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time- Effectiveness||||
73900404|NCT03718299|147331832|SUPERIORITY||||||<|0.001|||||||Exact binomial test|||Treatment Satisfaction Questionnaire for Medication over time-Side Effects||||<0.001
73900405|NCT03718299|147331832|SUPERIORITY||Mean|82.2|STANDARD_DEVIATION|16.35|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time - Convenience||||
73900406|NCT03718299|147331832|SUPERIORITY||Mean|81.9|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time - Global Satisfaction||||
73900407|NCT03718299|147331833|SUPERIORITY||Mean|8.7|STANDARD_DEVIATION|2.01|||TWO_SIDED|||||||||Improvement in Symptoms||||
73900408|NCT03718299|147331833|SUPERIORITY||Mean|8.3|STANDARD_DEVIATION|2.3|||TWO_SIDED|||||||||Speed of Symptom Improvement||||
73900409|NCT03718299|147331833|SUPERIORITY||Mean|9.1|STANDARD_DEVIATION|1.7|||TWO_SIDED|||||||||Frequency of Taking Medication||||
73900410|NCT03718299|147331833|SUPERIORITY||Mean|9.6|STANDARD_DEVIATION|0.68|||TWO_SIDED|||||||||Side Effects||||
73900411|NCT03718299|147331834|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73900412|NCT04389970|147331836|OTHER|Single group, within subject pre/post change.||||||0.39|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no conclusion of significance can be made.||||.39
73900413|NCT04389970|147331837|OTHER|Single group, within subject pre/post change.||||||0.3|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.3
73900414|NCT04389970|147331838|OTHER|Single group, within subjects pre/post change.||||||0.77|||||||t-test, 2 sided|Paired-sample t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.77
73900415|NCT04389970|147331839|OTHER|Single group, within subjects pre/post change.||||||0.66|||||||t-test, 2 sided|Paired-samples t-test.||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.66
73960762|NCT03260140|147457381|SUPERIORITY||Mean Difference (Net)|-0.22||||0.806|TWO_SIDED|95.0|-1.99|1.55|||Mixed Models Analysis|Difference in average SF-12 MCS score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month MCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.55|-1.99|0.806
73960763|NCT03260140|147457382|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.62|TWO_SIDED|95.0|-1.77|1.05|||Mixed Models Analysis|Difference in average DBP at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month DBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.05|-1.77|0.620
74023564|NCT02700451|147600011|EQUIVALENCE|Two-sided 95% confidence interval||||||0.58|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Enjoyment of life is the same across the 3 arms||||0.580
74023565|NCT02700451|147600013|EQUIVALENCE|Two-sided 95% confidence interval||||||0.928|||||||Kruskal-Wallis|||The distribution of Total Drain output at 24H is the same across the 3 arms||||0.928
74023566|NCT02700451|147600013|EQUIVALENCE|Two-sided 95% confidence interval||||||0.906|||||||Kruskal-Wallis|||The distribution of Total Drain output at 48H is the same across the 3 arms||||0.906
73900416|NCT04389970|147331840|OTHER|Single group, within subjects pre/post change||||||0.88|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.88
73900417|NCT04389970|147331841|OTHER|Single group, within subjects pre/post change||||||0.03|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.03
73900418|NCT04389970|147331842|OTHER|Single group, within subjects pre/post change.||||||0.06|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.06
73900419|NCT04389970|147331843|OTHER|Single group, within subjects pre/post change||||||0.04|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.04
73900420|NCT04389970|147331844|OTHER|Single group, within subjects analysis.||||||0|||||||t-test, 2 sided|Paired sample t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||0
73900421|NCT01931670|147331849|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
74023567|NCT02700451|147600013|EQUIVALENCE|Two-sided 95% confidence interval||||||0.926|||||||Kruskal-Wallis|||The distribution of Total Drain output at 72H is the same across the 3 arms||||0.926
73960764|NCT03260140|147457383|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.987|TWO_SIDED|95.0|-2.32|2.28|||Mixed Models Analysis|Difference in average SPB at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average SBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.28|-2.32|0.987
73960765|NCT00463788|147457384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.126||||0.1109|TWO_SIDED|95.0|0.809|5.591|||Cochran-Mantel-Haenszel|Randomization strata: first- or second line according to Interactive Voice Response System (IVRS).||||5.591|0.809|0.1109
73960766|NCT00463788|147457385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.675||||0.0324|TWO_SIDED|95.0|0.47|0.969|||Log Rank|||||0.969|0.470|0.0324
73960767|NCT00463788|147457386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.821||||0.3121|TWO_SIDED|95.0|0.561|1.204|||Log Rank|||||1.204|0.561|0.3121
73960768|NCT00463788|147457387|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.754||||0.5993|TWO_SIDED|95.0|0.262|2.17|||Log Rank|||||2.170|0.262|0.5993
73848674|NCT02722408|147242754|OTHER|||||||0.0669||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0669
73848675|NCT02722408|147242754|OTHER|||||||0.0189||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0189
73848676|NCT02722408|147242754|OTHER|||||||0.0316||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0316
73848677|NCT02722408|147242755|OTHER|||||||0.0685||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0685
73848678|NCT02722408|147242755|OTHER|||||||0.0114||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0114
73848679|NCT02722408|147242755|OTHER|||||||0.0263||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0263
73848680|NCT02722408|147242756|OTHER|||||||0.1466||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1466
73960769|NCT00360698|147457389|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.68||||0.0499||95.0|0.01|28.37|||Chi-squared||Difference in percentage between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the percentage of patients with Glycosylated Haemoglobin (HbA1c) level \<7%. A sample size of 98 randomized (49/arm) patients would allow to demonstrate with 80% power that 40 % of patients in the Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group would achieve a HbA1c level \< 7 % compared to 15 % of patients in the Insulin Glargine+Metformin+Glimepiride group(5% alpha risk, 2-sided test).||28.37|0.01|0.0499
74023568|NCT02700451|147600013|EQUIVALENCE|Two-sided 95% confidence interval||||||0.934|||||||Kruskal-Wallis|||The distribution of Total Drain output at Discharge is the same across the 3 arms||||0.934
74023569|NCT02700451|147600014|EQUIVALENCE|Two-sided||||||0.078|||||||Chi-squared|||Proportion of patient receiving at least 1 transfusion is the same across the 3 arms||||0.078
73848681|NCT02722408|147242756|OTHER|||||||0.3598||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3598
73848682|NCT02722408|147242756|OTHER|||||||0.0685||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0685
73848683|NCT02722408|147242757|OTHER|||||||0.166||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1660
73848684|NCT02722408|147242757|OTHER|||||||0.3423||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3423
73848685|NCT02722408|147242757|OTHER|||||||0.0313||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0313
73848686|NCT02722408|147242758|OTHER|||||||0.7196||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.7196
73848687|NCT02722408|147242758|OTHER|||||||0.4343||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.4343
73900422|NCT01931670|147331849|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
73900423|NCT01931670|147331850|SUPERIORITY|||||||0.003||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||0.003
73900424|NCT01931670|147331850|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
73900425|NCT01931670|147331851|SUPERIORITY||Difference in LS Mean Change|-0.57|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||<0.001
73900426|NCT01931670|147331851|SUPERIORITY||Difference in LS Mean Change|-1.22|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
73900427|NCT01931670|147331852|SUPERIORITY||Difference in LS Mean Change|-0.54|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
73900428|NCT01931670|147331852|SUPERIORITY||Difference in LS Mean Change|-1.13|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
73900429|NCT01931670|147331853|SUPERIORITY||Difference in LS Mean Change|-0.15|STANDARD_ERROR_OF_MEAN|0.056||0.009|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||0.009
73900430|NCT01931670|147331853|SUPERIORITY||Difference in LS Mean Change|-0.32|STANDARD_ERROR_OF_MEAN|0.056|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||< 0.001
73900431|NCT01931670|147331854|SUPERIORITY||Difference in LS Mean Change|-0.05|STANDARD_ERROR_OF_MEAN|0.044||0.26|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||0.26
73960770|NCT00360698|147457391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.116||0.029||95.0|-0.49|-0.03||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline HbA1c as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no difference between the 2 treatment groups regarding the adjusted mean change from baseline in Glycosylated Haemoglobin (HbA1c) at the end of treatment.||-0.03|-0.49|0.029
73960771|NCT00360698|147457393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.94|STANDARD_ERROR_OF_MEAN|4.987||0.0109||95.0|-22.83|-3.04||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline daily mean plasma glucose as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in daily mean plasma glucose at the end of treatment.||-3.04|-22.83|0.0109
73900432|NCT01931670|147331854|SUPERIORITY||Difference in LS Mean Change|-0.18|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||< 0.001
73900433|NCT01931670|147331855|SUPERIORITY||Difference in LS Mean Change|-0.08|STANDARD_ERROR_OF_MEAN|0.048||0.088|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||0.088
73900434|NCT01931670|147331855|SUPERIORITY||Difference in LS Mean Change|-0.21|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||< 0.001
73960772|NCT00360698|147457394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.431||0.5762||95.0|-0.61|1.1||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline weight as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in weight at the end of treatment.||1.1|-0.61|0.5762
73900435|NCT01931670|147331856|SUPERIORITY||Difference in LS Mean Change|-0.09|STANDARD_ERROR_OF_MEAN|0.067||0.172|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.172
73900436|NCT01931670|147331856|SUPERIORITY||Difference in LS Mean Change|-0.3|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||< 0.001
73848688|NCT02722408|147242758|OTHER|||||||0.7241||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.7241
73848689|NCT02722408|147242759|OTHER|||||||0.7952||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.7952
73900437|NCT01931670|147331857|SUPERIORITY||Difference in LS Mean Change|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.968|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.968
73900438|NCT01931670|147331857|SUPERIORITY||Difference in LS Mean Change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.007|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.007
73900439|NCT01931670|147331858|SUPERIORITY||Odds Ratio (OR)|2.361|||<|0.001|TWO_SIDED|97.5|1.507|3.697|||Regression, Logistic|||Month 1||3.697|1.507|< 0.001
73900440|NCT01931670|147331858|SUPERIORITY||Odds Ratio (OR)|4.185|||<|0.001|TWO_SIDED|97.5|2.707|6.469|||Regression, Logistic|||Month 1||6.469|2.707|< 0.001
73900441|NCT01931670|147331858|SUPERIORITY||Odds Ratio (OR)|2.795|||<|0.001|TWO_SIDED|97.5|1.811|4.312|||Regression, Logistic|||Month 2||4.312|1.811|< 0.001
73900442|NCT01931670|147331858|SUPERIORITY||Odds Ratio (OR)|10.378|||<|0.001|TWO_SIDED|97.5|6.615|16.282|||Regression, Logistic|||Month 2||16.282|6.615|< 0.001
74023570|NCT02700451|147600015|EQUIVALENCE|Two-sided 95% confidence interval||||||792|||||||Chi-squared|||||||0792
73848690|NCT02722408|147242759|OTHER|||||||0.4931||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.4931
73848691|NCT02722408|147242759|OTHER|||||||0.8622||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.8622
73848692|NCT02722408|147242760|OTHER|||||||0.9823||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.9823
73900443|NCT01931670|147331858|SUPERIORITY||Odds Ratio (OR)|3.178|||<|0.001|TWO_SIDED|97.5|2.084|4.845|||Regression, Logistic|||Month 4||4.845|2.084|< 0.001
73900444|NCT01931670|147331858|SUPERIORITY||Odds Ratio (OR)|15.216|||<|0.001|TWO_SIDED|97.5|9.429|24.554|||Regression, Logistic|||Month 4||24.554|9.429|< 0.001
73900445|NCT01931670|147331858|SUPERIORITY||Odds Ratio (OR)|2.548|||<|0.001|TWO_SIDED|97.5|1.683|3.859|||Regression, Logistic|||Month 5||3.859|1.683|< 0.001
73900446|NCT01931670|147331858|SUPERIORITY||Odds Ratio (OR)|14.055|||<|0.001|TWO_SIDED|97.5|8.716|22.664|||Regression, Logistic|||Month 5||22.664|8.716|< 0.001
73900447|NCT01931670|147331858|SUPERIORITY||Odds Ratio (OR)|2.536|||<|0.001|TWO_SIDED|97.5|1.685|3.816|||Regression, Logistic|||Month 6||3.816|1.685|< 0.001
73900448|NCT01931670|147331858|SUPERIORITY||Odds Ratio (OR)|10.106|||<|0.001|TWO_SIDED|97.5|6.434|15.874|||Regression, Logistic|||Month 6||15.874|6.434|< 0.001
73900449|NCT01931670|147331859|SUPERIORITY||Odds Ratio (OR)|1.191||||0.376|TWO_SIDED|97.5|0.765|1.855|||Regression, Logistic|||Month 1||1.855|0.765|0.376
73900450|NCT01931670|147331859|SUPERIORITY||Odds Ratio (OR)|1.376||||0.101|TWO_SIDED|97.5|0.89|2.127|||Regression, Logistic|||Month 1||2.127|0.890|0.101
73900451|NCT01931670|147331859|SUPERIORITY||Odds Ratio (OR)|1.358||||0.088|TWO_SIDED|97.5|0.909|2.029|||Regression, Logistic|||Month 2||2.029|0.909|0.088
73900452|NCT01931670|147331859|SUPERIORITY||Odds Ratio (OR)|2.208|||<|0.001|TWO_SIDED|97.5|1.488|3.278|||Regression, Logistic|||Month 2||3.278|1.488|< 0.001
73900453|NCT01931670|147331859|SUPERIORITY||Odds Ratio (OR)|1.678||||0.003|TWO_SIDED|97.5|1.136|2.477|||Regression, Logistic|||Month 4||2.477|1.136|0.003
73900454|NCT01931670|147331859|SUPERIORITY||Odds Ratio (OR)|2.722|||<|0.001|TWO_SIDED|97.5|1.832|4.044|||Regression, Logistic|||Month 4||4.044|1.832|< 0.001
73900455|NCT01931670|147331859|SUPERIORITY||Odds Ratio (OR)|1.537||||0.013|TWO_SIDED|97.5|1.042|2.267|||Regression, Logistic|||Month 5||2.267|1.042|0.013
73900456|NCT01931670|147331859|SUPERIORITY||Odds Ratio (OR)|2.598|||<|0.001|TWO_SIDED|97.5|1.75|3.857|||Regression, Logistic|||Month 5||3.857|1.750|< 0.001
73900457|NCT01931670|147331859|SUPERIORITY||Odds Ratio (OR)|1.565||||0.01|TWO_SIDED|97.5|1.062|2.306|||Regression, Logistic|||Month 6||2.306|1.062|0.01
74023571|NCT02700451|147600016|EQUIVALENCE|Two-sided 95% confidence interval||||||0.034|||||||Kruskal-Wallis|||The distribution of Length of stay in day is the same across these arms||||0.034
73848693|NCT02722408|147242760|OTHER|||||||0.9129||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.9129
73848694|NCT02722408|147242760|OTHER|||||||0.7762||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 84||||0.7762
73848695|NCT02722408|147242761|OTHER|||||||0.2683||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.2683
73848696|NCT02722408|147242761|OTHER|||||||0.088||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0880
74023572|NCT02700451|147600016|EQUIVALENCE|Two-sided 95% confidence interval||||||0.03|||||||Kruskal-Wallis|||The distribution of Length of stay in hour is the same across these arms||||0.030
74023573|NCT02700451|147600017|EQUIVALENCE|Two-sided 95% confidence interval||||||0.974|||||||ANOVA|||Comparison of the PCS score between the 3 arms||||0.974
74023574|NCT02700451|147600017|EQUIVALENCE|Two-sided 95% confidence interval||||||0.444|||||||ANOVA|||Comparison of the MCS between the 3 ams||||0.444
74023575|NCT02700451|147600018|EQUIVALENCE|Two-sided 95% confidence interval||||||0.215|||||||ANOVA|||||||0.215
74023576|NCT02700451|147600019|EQUIVALENCE|Two-sided 95% confidence interval||||||0.044|||||||ANOVA|||Comparison PCS score between the 3 arms||||0.044
73900458|NCT01931670|147331859|SUPERIORITY||Odds Ratio (OR)|2.412|||<|0.001|TWO_SIDED|97.5|1.63|3.57|||Regression, Logistic|||Month 6||3.570|1.630|< 0.001
73900459|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|1.028||||0.901|TWO_SIDED|97.5|0.624|1.693|||Regression, Logistic|||Month 1||1.693|0.624|0.901
73900460|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|1.103||||0.65|TWO_SIDED|97.5|0.68|1.789|||Regression, Logistic|||Month 1||1.789|0.680|0.65
73900461|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|1.351||||0.154|TWO_SIDED|97.5|0.841|2.17|||Regression, Logistic|||Month 2||2.170|0.841|0.154
73900462|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|1.871||||0.003|TWO_SIDED|97.5|1.175|2.979|||Regression, Logistic|||Month 2||2.979|1.175|0.003
73900463|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|1.25||||0.294|TWO_SIDED|97.5|0.776|2.013|||Regression, Logistic|||Month 3||2.013|0.776|0.294
73900464|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|1.865||||0.003|TWO_SIDED|97.5|1.163|2.989|||Regression, Logistic|||Month 3||2.989|1.163|0.003
73900465|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|1.145||||0.521|TWO_SIDED|97.5|0.713|1.839|||Regression, Logistic|||Month 4||1.839|0.713|0.521
73900466|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|2.474|||<|0.001|TWO_SIDED|97.5|1.544|3.963|||Regression, Logistic|||Month 4||3.963|1.544|< 0.001
73900467|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|1.262||||0.27|TWO_SIDED|97.5|0.787|2.023|||Regression, Logistic|||Month 5||2.023|0.787|0.27
73900468|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|2.416|||<|0.001|TWO_SIDED|97.5|1.5|3.891|||Regression, Logistic|||Month 5||3.891|1.500|< 0.001
73900469|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|1.013||||0.953|TWO_SIDED|97.5|0.631|1.624|||Regression, Logistic|||Month 6||1.624|0.631|0.953
73900470|NCT01931670|147331860|SUPERIORITY||Odds Ratio (OR)|1.997|||<|0.001|TWO_SIDED|97.5|1.253|3.183|||Regression, Logistic|||Month 6||3.183|1.253|< 0.001
73900471|NCT01931670|147331861|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.69|-0.37|||mixed-effects model|||Month 1||-0.37|-0.69|< 0.001
73900472|NCT01931670|147331861|SUPERIORITY||LS Mean of Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.94|-0.62|||mixed-effects model|||Month 1||-0.62|-0.94|< 0.001
73900473|NCT01931670|147331861|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.6|-0.29|||mixed-effects model|||Month 2||-0.29|-0.6|< 0.001
73900474|NCT01931670|147331861|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-1.43|-1.12|||mixed-effects model|||Month 2||-1.12|-1.43|< 0.001
73900475|NCT01931670|147331861|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.68|-0.37|||mixed-effects model|||Month 3||-0.37|-0.68|< 0.001
73900476|NCT01931670|147331861|SUPERIORITY||LS Mean of Difference|-1.25|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|97.5|-1.4|-1.09|||mixed-effects model|||Month 3||-1.09|-1.4|< 0.001
73900477|NCT01931670|147331861|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.73|-0.42|||mixed-effects model|||Month 4||-0.42|-0.73|< 0.001
73900478|NCT01931670|147331861|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-1.42|-1.11|||mixed-effects model|||Month 4||-1.11|-1.42|< 0.001
73900479|NCT01931670|147331861|SUPERIORITY||LS Mean of Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.65|-0.33|||mixed-effects model|||Month 5||-0.33|-0.65|< 0.001
73900480|NCT01931670|147331861|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-1.42|-1.1|||mixed-effects model|||Month 5||-1.10|-1.42|< 0.001
73900481|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-25.31|STANDARD_ERROR_OF_MEAN|3.669|<|0.001|TWO_SIDED|97.5|-33.55|-17.07|||mixed-effects model|||Month 1||-17.07|-33.55|< 0.001
73900482|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-39.32|STANDARD_ERROR_OF_MEAN|3.657|<|0.001|TWO_SIDED|97.5|-47.53|-31.11|||mixed-effects model|||Month 1||-31.11|-47.53|< 0.001
73900483|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-21.9|STANDARD_ERROR_OF_MEAN|3.355|<|0.001|TWO_SIDED|97.5|-29.44|-14.36|||mixed-effects model|||Month 2||-14.36|-29.44|< 0.001
73900484|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-63.31|STANDARD_ERROR_OF_MEAN|3.365|<|0.001|TWO_SIDED|97.5|-70.87|-55.76|||mixed-effects model|||Month 2||-55.76|-70.87|< 0.001
74023577|NCT02700451|147600019|EQUIVALENCE|Two-sided 95% confidence interval||||||0.767|||||||ANOVA|||Comparison MCS score between the 3 arms||||0.767
74023578|NCT02700451|147600020|EQUIVALENCE|Two-sided 95% confidence interval||||||0.191|||||||ANOVA|||||||0.191
74023579|NCT01564784|147600075|SUPERIORITY_OR_OTHER||Rate difference|51.4|||<|0.0001|TWO_SIDED|97.5|38.4|64.3|||1-sided p-value based on Chi-square test|If any cell count was \<5, p-value was based on Fisher's exact test||||64.3|38.4|<0.0001
74023580|NCT01564784|147600076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0105|TWO_SIDED|97.5|0.568|0.993|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.993|0.568|0.0105
73848697|NCT02722408|147242761|OTHER|||||||0.0165||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0165
73848698|NCT02722408|147242762|OTHER|||||||0.4585||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4585
73848699|NCT02722408|147242762|OTHER|||||||0.3721||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3721
73848700|NCT02722408|147242762|OTHER|||||||0.5305||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.5305
73848701|NCT02722408|147242763|OTHER|||||||0.2937||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.2937
73848702|NCT02722408|147242763|OTHER|||||||0.2182||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.2182
73848703|NCT02722408|147242763|OTHER|||||||0.2937||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2937
73848704|NCT02722408|147242764|OTHER|||||||0.0411||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0411
73848705|NCT02722408|147242764|OTHER|||||||0.0192||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0192
74023581|NCT01564784|147600077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.0021|TWO_SIDED|95.0|0.297|0.809|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.809|0.297|0.0021
74023582|NCT01564784|147600078|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|97.5|0.336|0.602|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.602|0.336|<0.0001
74023583|NCT01564784|147600079|SUPERIORITY_OR_OTHER||Rate difference|31.6|||<|0.0001|TWO_SIDED|95.0|22.6|40.6|||1-sided p-value based on Chi-square test|If any cell count was \<5, p-value was based on Fisher's exact test||||40.6|22.6|<0.0001
74023584|NCT01564784|147600080|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||||||<0.0001
74023585|NCT01564784|147600081|SUPERIORITY_OR_OTHER|||||||0.3168|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||Abnormal at Screening||||0.3168
74023586|NCT01564784|147600081|SUPERIORITY_OR_OTHER|||||||0.216|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||Abnormal after remission||||0.2160
74023587|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9||||0.0139|TWO_SIDED|95.0|1.4|12.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Physical Functioning||12.3|1.4|0.0139
74023588|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.4||||0.0065|TWO_SIDED|95.0|3.2|19.5|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Role Functioning||19.5|3.2|0.0065
74023589|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.3307|TWO_SIDED|95.0|-6.9|2.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Emotional Functioning||2.3|-6.9|0.3307
74023590|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.1904|TWO_SIDED|95.0|-1.4|7.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Cognitive Functioning||7.0|-1.4|0.1904
74023591|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.4||||0.0336|TWO_SIDED|95.0|0.7|16.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Social Functioning||16.1|0.7|0.0336
74023592|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.1572|TWO_SIDED|95.0|-1.7|10.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Global Health Status||10.3|-1.7|0.1572
74023593|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.1281|TWO_SIDED|95.0|-10.8|1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Dyspnoea||1.4|-10.8|0.1281
74023594|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.6207|TWO_SIDED|95.0|-8.7|5.2|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Insomnia||5.2|-8.7|0.6207
73960773|NCT00360698|147457397|SUPERIORITY_OR_OTHER|||||||0.958||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of symptomatic hypoglycemia with plasma glucose \<70 mg/dL during the treatment period.||||0.958
73960774|NCT00360698|147457398|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of nocturnal symptomatic hypoglycemia with plasma glucose \<70 mg/dL during the treatment period.||||0.302
73960775|NCT00360698|147457399|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of severe symptomatic hypoglycemia during the treatment period.||||0.192
73848706|NCT02722408|147242764|OTHER|||||||0.0445||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0445
73848707|NCT02722408|147242765|OTHER|||||||0.0465||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0465
73848708|NCT02722408|147242765|OTHER|||||||0.0221||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0221
73848709|NCT02722408|147242765|OTHER|||||||0.0402||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0402
73848710|NCT00298389|147242778|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
73848711|NCT00298389|147242779|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
73848712|NCT00288015|147242780|OTHER|This is a two-stage optimal simon design. If bevacizumab is not effective, there is a 0.050 probability of concluding that it is. If bevacizumab is effective, there is a 0.2000 probability of concluding that it is not.||||||||||||In first stage 12 patients will be entered, if \</=3 patients have PFS time\>3 months p\</=0.22 is likely true. In second stage a total of up to 31 patients data will be analysed. If \>/=10 patients show PFS\</=3 months, it will suggest p\>0.50 is true.|Kaplan-Meier estimate|||This is a two stage optimal simon design testing the Null hypothesis: bevacizumab is not effective with P\<=0.220 and the alternative hypothesis: bevacizumab is effective with P \>=0.450 and has a sample size of 16.96 and a probability of early termination of 0.739. p=probability (progression free survival - PFS time\>/=3 months).|P\<=0.220 is the threshold value of significance that the null hypothesis is true or the alternative hypothesis is true. P Value was not calculated from the data. Median survival time was calculated using a 20% censored Kaplan-Meier table and graph.|||
73960776|NCT01667796|147457404|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||univariate generalized estimating equati|||||||0.001
73960777|NCT01667796|147457404|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Adjusted for adherence, body mass index, and oral contraceptive use|Generalized estimating equation|||||||0.008
73848713|NCT04776161|147242816|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.78|TWO_SIDED|95.0|-0.16|0.12|||Generalized linear models|Adjusted for age, sex, race||||0.12|-0.16|0.78
73848714|NCT04776161|147242816|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.79|TWO_SIDED|95.0|-0.1|0.13|||Generalized linear models|Adjusted for age, sex, race||||0.13|-0.10|0.79
73848715|NCT04776161|147242817|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.22|TWO_SIDED|95.0|-0.28|1.22|||Generalized linear models|Adjusted for age, sex, race and baseline uric acid level.||||1.22|-0.28|0.22
73848716|NCT04776161|147242817|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.24|TWO_SIDED|95.0|-0.33|1.26|||Generalized linear models|Adjusted for age, sex, race and baseline uric acid level||||1.26|-0.33|0.24
73848717|NCT04552041|147242818|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 24 weeks row.||||<0.0001
73848718|NCT04552041|147242819|SUPERIORITY|||||||0.0028|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 24 weeks row.||||0.0028
73848719|NCT04552041|147242819|SUPERIORITY|||||||0.1739|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Delusional ideas ∆ between baseline and 24 weeks row."||||0.1739
73848720|NCT04552041|147242819|SUPERIORITY|||||||0.0559|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Hallucinations ∆ between baseline and 24 weeks row."||||0.0559
73848721|NCT04552041|147242819|SUPERIORITY|||||||0.0174|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Agitation ∆ between baseline and 24 weeks row."||||0.0174
73848722|NCT04552041|147242819|SUPERIORITY|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aggression ∆ between baseline and 24 weeks row."||||0.3330
73848723|NCT04552041|147242819|SUPERIORITY|||||||0.1037|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Dysphoria ∆ between baseline and 24 weeks row."||||0.1037
73848724|NCT04552041|147242819|SUPERIORITY|||||||0.0329|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Anxiety ∆ between baseline and 24 weeks row."||||0.0329
73848725|NCT04552041|147242819|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Euphoria ∆ between baseline and 24 weeks row."||||0.2700
73848726|NCT04552041|147242819|SUPERIORITY|||||||0.0557|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Apathy ∆ between baseline and 24 weeks row."||||0.0557
73848727|NCT04552041|147242819|SUPERIORITY|||||||0.982|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Disinhibition ∆ between baseline and 24 weeks row."||||0.9820
74023595|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.7||||0.0193|TWO_SIDED|95.0|-16.0|-1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Appetite Loss||-1.4|-16.0|0.0193
73900485|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-25.15|STANDARD_ERROR_OF_MEAN|3.241|<|0.001|TWO_SIDED|97.5|-32.43|-17.88|||mixed-effects model|||Month 3||-17.88|-32.43|< 0.001
73900486|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-61.94|STANDARD_ERROR_OF_MEAN|3.233|<|0.001|TWO_SIDED|97.5|-69.2|-54.68|||mixed-effects model|||Month 3||-54.68|-69.20|< 0.001
73900487|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-26.97|STANDARD_ERROR_OF_MEAN|3.344|<|0.001|TWO_SIDED|97.5|-34.48|-19.46|||mixed-effects model|||Month 4||-19.46|-34.48|< 0.001
73900488|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-62.37|STANDARD_ERROR_OF_MEAN|3.346|<|0.001|TWO_SIDED|97.5|-69.89|-54.86|||mixed-effects model|||Month 4||-54.86|-69.89|< 0.001
73900489|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-23.36|STANDARD_ERROR_OF_MEAN|3.428|<|0.001|TWO_SIDED|97.5|-31.06|-15.66|||mixed-effects model|||Month 5||-15.66|-31.06|< 0.001
73900490|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-62.9|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|97.5|-70.58|-55.22|||mixed-effects model|||Month 5||-55.22|-70.58|< 0.001
73900491|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-25.89|STANDARD_ERROR_OF_MEAN|3.528|<|0.001|TWO_SIDED|97.5|-33.81|-17.97|||mixed-effects model|||Month 6||-17.97|-33.81|< 0.001
73900492|NCT01931670|147331862|SUPERIORITY||LS Mean of Difference|-56.62|STANDARD_ERROR_OF_MEAN|3.522|<|0.001|TWO_SIDED|97.5|-64.53|-48.7|||mixed-effects model|||Month 6||-48.70|-64.53|< 0.001
73900493|NCT01931670|147331863|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.549|TWO_SIDED|97.5|-0.11|0.07|||mixed-effects model|||Month 1||0.07|-0.11|0.549
74023596|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.6249|TWO_SIDED|95.0|-4.4|7.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Constipation||7.3|-4.4|0.6249
73900494|NCT01931670|147331863|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.02|TWO_SIDED|97.5|-0.18|0.0|||mixed-effects model|||Month 1||0.00|-0.18|0.02
73900495|NCT01931670|147331863|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.11|TWO_SIDED|97.5|-0.17|0.03|||mixed-effects model|||Month 2||0.03|-0.17|0.11
73900496|NCT01931670|147331863|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.043|<|0.001|TWO_SIDED|97.5|-0.3|-0.11|||mixed-effects model|||Month 2||-0.11|-0.30|< 0.001
73900497|NCT01931670|147331863|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.041|TWO_SIDED|97.5|-0.22|0.01|||mixed-effects model|||Month 3||0.01|-0.22|0.041
73900498|NCT01931670|147331863|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|97.5|-0.41|-0.18|||mixed-effects model|||Month 3||-0.18|-0.41|< 0.001
73900499|NCT01931670|147331863|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.052||0.081|TWO_SIDED|97.5|-0.21|0.03|||mixed-effects model|||Month 4||0.03|-0.21|0.081
73900500|NCT01931670|147331863|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.052|<|0.001|TWO_SIDED|97.5|-0.45|-0.22|||mixed-effects model|||Month 4||-0.22|-0.45|<0.001
73900501|NCT01931670|147331863|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.054||0.062|TWO_SIDED|97.5|-0.22|0.02|||mixed-effects model|||Month 5||0.02|-0.22|0.062
73900502|NCT01931670|147331863|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.46|-0.22|||mixed-effects model|||Month 5||-0.22|-0.46|< 0.001
73900503|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-3.04|STANDARD_ERROR_OF_MEAN|2.94||0.301|TWO_SIDED|97.5|-9.64|3.56|||mixed-effects model|||Month 1||3.56|-9.64|0.301
73900504|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-6.43|STANDARD_ERROR_OF_MEAN|2.92||0.028|TWO_SIDED|97.5|-12.99|0.13|||mixed-effects model|||Month 1||0.13|-12.99|0.028
73900505|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-5.17|STANDARD_ERROR_OF_MEAN|2.964||0.082|TWO_SIDED|97.5|-11.82|1.49|||mixed-effects model|||Month 2||1.49|-11.82|0.082
73900506|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-13.19|STANDARD_ERROR_OF_MEAN|2.956|<|0.001|TWO_SIDED|97.5|-19.83|-6.55|||mixed-effects model|||Month 2||-6.55|-19.83|< 0.001
73900507|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-6.84|STANDARD_ERROR_OF_MEAN|3.379||0.043|TWO_SIDED|97.5|-14.43|0.75|||mixed-effects model|||Month 3||0.75|-14.43|0.043
73900508|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-19.05|STANDARD_ERROR_OF_MEAN|3.364|<|0.001|TWO_SIDED|97.5|-26.61|-11.49|||mixed-effects model|||Month 3||-11.49|-26.61|< 0.001
73900509|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-6.25|STANDARD_ERROR_OF_MEAN|3.473||0.072|TWO_SIDED|97.5|-14.05|1.55|||mixed-effects model|||Month 4||1.55|-14.05|0.072
73900510|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-21.58|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|97.5|-29.35|-13.81|||mixed-effects model|||Month 4||-13.81|-29.35|< 0.001
74023597|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.1534|TWO_SIDED|95.0|-7.2|1.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Diarrhoea||1.1|-7.2|0.1534
74023598|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.5||||0.4915|TWO_SIDED|95.0|-9.7|4.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Financial Difficulties||4.7|-9.7|0.4915
74023599|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4||||0.1789|TWO_SIDED|95.0|-10.8|2.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Fatigue||2.0|-10.8|0.1789
74023600|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.4578|TWO_SIDED|95.0|-6.0|2.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Nausea and Vomiting||2.7|-6.0|0.4578
74023601|NCT01564784|147600083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.8428|TWO_SIDED|95.0|-7.3|6.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Pain||6.0|-7.3|0.8428
74023602|NCT01564784|147600084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.171|TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||||0.07|-0.01|0.1710
74023603|NCT01564784|147600085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.6||||0.1172|TWO_SIDED|95.0|-1.2|10.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||||10.4|-1.2|0.1172
73848728|NCT04552041|147242819|SUPERIORITY|||||||0.4626|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Irritability ∆ between baseline and 24 weeks row."||||0.4626
73848729|NCT04552041|147242819|SUPERIORITY|||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aberrant motor behaviour ∆ between baseline and 24 weeks row."||||0.0006
73848730|NCT04552041|147242819|SUPERIORITY|||||||0.3725|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Sleep disorders ∆ between baseline and 24 weeks row."||||0.3725
73848731|NCT04552041|147242819|SUPERIORITY|||||||0.1013|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Appetite disorders ∆ between baseline and 24 weeks row."||||0.1013
73900511|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-6.21|STANDARD_ERROR_OF_MEAN|3.536||0.08|TWO_SIDED|97.5|-14.15|1.73|||mixed-effects model|||Month 5||1.73|-14.15|0.08
73900512|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-21.66|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|97.5|-29.56|-13.75|||mixed-effects model|||Month 5||-13.75|-29.56|< 0.001
73900513|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-10.83|STANDARD_ERROR_OF_MEAN|3.744||0.004|TWO_SIDED|97.5|-19.24|-2.43|||mixed-effects model|||Month 6||-2.43|-19.24|0.004
73900514|NCT01931670|147331864|SUPERIORITY||LS Mean of Difference|-21.16|STANDARD_ERROR_OF_MEAN|3.729|<|0.001|TWO_SIDED|97.5|-29.54|-12.79|||mixed-effects model|||Month 6||-12.79|-29.54|< 0.001
73900515|NCT01931670|147331865|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.059||0.688|TWO_SIDED|97.5|-0.11|0.16|||mixed-effects model|||Month 1||0.16|-0.11|0.688
73900516|NCT01931670|147331865|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.058||0.431|TWO_SIDED|97.5|-0.18|0.08|||mixed-effects model|||Month 1||0.08|-0.18|0.431
73900517|NCT01931670|147331865|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.277|TWO_SIDED|97.5|-0.2|0.07|||mixed-effects model|||Month 2||0.07|-0.20|0.277
73900518|NCT01931670|147331865|SUPERIORITY||LS Mean of Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|97.5|-0.37|-0.1|||mixed-effects model|||Month 2||-0.10|-0.37|< 0.001
73900519|NCT01931670|147331865|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.071||0.494|TWO_SIDED|97.5|-0.21|0.11|||mixed-effects model|||Month 4||0.11|-0.21|0.494
73900520|NCT01931670|147331865|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.43|-0.11|||mixed-effects model|||Month 4||-0.11|-0.43|< 0.001
73900521|NCT01931670|147331865|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.072||0.765|TWO_SIDED|97.5|-0.18|0.14|||mixed-effects model|||Month 5||0.14|-0.18|0.765
73900522|NCT01931670|147331865|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.073|<|0.001|TWO_SIDED|97.5|-0.47|-0.15|||mixed-effects model|||Month 5||-0.15|-0.47|< 0.001
73848732|NCT04552041|147242819|SUPERIORITY|||||||0.0432|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aberrant vocalizations ∆ between baseline and 24 weeks row."||||0.0432
73848733|NCT04552041|147242820|SUPERIORITY|||||||0.0316|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 12 weeks row.||||0.0316
73848734|NCT04552041|147242821|SUPERIORITY|||||||0.1483|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 12 weeks row.||||0.1483
73848735|NCT04552041|147242822|SUPERIORITY|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Therapeutic effect row.||||0.0018
73848736|NCT04552041|147242822|SUPERIORITY|||||||0.4733|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Side effects row.||||0.4733
73848737|NCT04552041|147242822|SUPERIORITY|||||||0.0035|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Efficiency index row.||||0.0035
73848738|NCT00661830|147242837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.281|||||TWO_SIDED|95.0|0.811|2.023|||Regression, Cox|||||2.023|0.811|
73848739|NCT00661830|147242838|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.747|1.927|||Regression, Cox|||||1.927|0.747|
73848740|NCT00980148|147242875|NON_INFERIORITY_OR_EQUIVALENCE|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The treatment failure rate was assumed to be 3% for both treatments. To test this hypothesis at the one-sided 0.10 significance level with power of 0.90 required 153 study subjects per arm in the per-protocol population.|Risk Difference (RD)|3.2|||||ONE_SIDED|90.0||5.9|||||The risk difference is the percentage in the azithromycin arm with treatment failure minus the percentage in the doxycycline arm with treatment failure. Noninferiority of azithromycin would be supported if the upper 90% confidence limit is below 5%.|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The one-sided 90% exact confidence interval was used to estimate the difference between the two failures rates.||5.9||
73900523|NCT01931670|147331865|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_DEVIATION|0.076||0.468|TWO_SIDED|97.5|-0.23|0.12|||mixed-effects model|||Month 6||0.12|-0.23|0.468
73900524|NCT01931670|147331865|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|97.5|-0.5|-0.16|||mixed-effects model|||Month 6||-0.16|-0.50|< 0.001
73900525|NCT01931670|147331866|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.029|TWO_SIDED|97.5|-0.18|0.0|||mixed-effects model|||Month 1||0.00|-0.18|0.029
73900526|NCT01931670|147331866|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.039||0.004|TWO_SIDED|97.5|-0.2|-0.03|||mixed-effects model|||Month 1||-0.03|-0.20|0.004
73900527|NCT01931670|147331866|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.042||0.076|TWO_SIDED|97.5|-0.17|0.02|||mixed-effects model|||Month 2||0.02|-0.17|0.076
73900528|NCT01931670|147331866|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.042|<|0.001|TWO_SIDED|97.5|-0.28|-0.09|||mixed-effects model|||Month 2||-0.09|-0.28|< 0.001
73900529|NCT01931670|147331866|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.045||0.058|TWO_SIDED|97.5|-0.19|0.02|||mixed-effects model|||Month 4||0.02|-0.19|0.058
74023604|NCT03871491|147600087|SUPERIORITY||Risk Ratio (RR)|0.67|||<|0.001|TWO_SIDED|95.0|0.56|0.79||We calculated P values to test each of the primary hypotheses at an alpha level of 0.05 overall, with a nominal alpha level of 0.0001 at the interim analysis.|Regression, Logistic|Used multiple imputation for missing outcomes by means of logistic regression imputation.||The null hypothesis is there is no treatment effect on the incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery||0.79|0.56|<0.001
74023605|NCT03871491|147600088|SUPERIORITY||Risk Ratio (RR)|1.02||||0.56|TWO_SIDED|95.0|0.95|1.09||We calculated P values to test each of the primary hypotheses at an alpha level of 0.05 overall, with a nominal alpha level of 0.0001 at the interim analysis.|Regression, Logistic|Used multiple imputation for missing outcomes by means of logistic regression imputation.||The null hypothesis is there is no treatment effect on the incidence of Intrapartum/Neonatal Death or Sepsis Within 4 Weeks (28 Days) Post-delivery in Intervention vs. Placebo Group||1.09|0.95|0.56
74023606|NCT03871491|147600089|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.55|0.77||||||||0.77|0.55|
74023607|NCT03871491|147600090|SUPERIORITY||Risk Ratio (RR)|4.04|||||TWO_SIDED|95.0|0.45|36.14||||||||36.14|0.45|
74023608|NCT03871491|147600092|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.55|0.79||||||||0.79|0.55|
74023609|NCT03871491|147600093|SUPERIORITY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.43|0.75||||||||0.75|0.43|
74023610|NCT03871491|147600094|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.65|0.99||||||||0.99|0.65|
74023611|NCT03871491|147600095|SUPERIORITY||Risk Ratio (RR)|0.69|||||TWO_SIDED|95.0|0.56|0.85||||||||0.85|0.56|
74023612|NCT03871491|147600096|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.95|1.01||||||||1.01|0.95|
74023613|NCT03871491|147600098|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.52|0.82||||||||0.82|0.52|
74023614|NCT03871491|147600099|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.7|1.15||||||||1.15|0.70|
74023615|NCT03871491|147600100|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.73|0.84||||||||0.84|0.73|
74023616|NCT03871491|147600101|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.84|1.41||||||||1.41|0.84|
73848741|NCT03420742|147242882|OTHER||Geometric least squares mean ratio|0.741|||||TWO_SIDED|90.0|0.6|0.915|||||The ratios of geometric mean were calculated on the basis of the within-participant variance. Participant was treated as a random effect in the model.|||0.915|0.600|
73848742|NCT03420742|147242883|OTHER||Geometric least squares mean ratio|0.836|||||TWO_SIDED|90.0|0.662|1.06|||||The ratios of geometric mean were calculated on the basis of the within-participant variance. Participant was treated as a random effect in the model.|||1.06|0.662|
73900530|NCT01931670|147331866|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|97.5|-0.32|-0.12|||mixed-effects model|||Month 4||-0.12|-0.32|< 0.001
74023617|NCT03871491|147600102|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.96|1.1||||||||1.1|0.96|
74023618|NCT03871491|147600103|SUPERIORITY||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.73|1.47||||||||1.47|0.73|
74023619|NCT03871491|147600104|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.88|1.07||||||||1.07|0.88|
74023620|NCT03871491|147600106|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.96|1.21||||||||1.21|0.96|
74023621|NCT03871491|147600107|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.94|1.12||||||||1.12|0.94|
74023622|NCT03871491|147600108|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.93|1.0||||||||1.0|0.93|
74023623|NCT03871491|147600109|SUPERIORITY||Risk Ratio (RR)|2.68|||||TWO_SIDED|95.0|0.71|10.1||||||||10.1|0.71|
74023624|NCT05202808|147600112|NON_INFERIORITY|"The endothelial cell loss (ECL) at 6 months was compared between the LAL and Control groups. The statistical hypothesis is:~* H0: Median(LAL) - Median(control) ≥ 5% vs~* Ha: Median(LAL) - Median(control) \< 5%~The median ECL for the LAL group is at most 5% higher than the median ECL for the Control group.~The first co-primary safety endpoint is met if the median ECL of the LAL group is non-inferior to the Control group using a right-tail Wilcoxon test using a significance level of 0.05."|Median Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|90.0|-1.0|1.66|||Wilcoxon (Mann-Whitney)|||With a one-sided significance level of 0.05, a power of 0.80, a randomization ratio of 2:1, and then the Mann-Whitney-Wilcoxon asymptotic relative efficiency (A.R.E.) efficiency adjustment, the sample size per two-sample t-test is 192 LAL eyes and 96 Control eyes (total of 288), with an assumed dropout rate of 10%.||1.66|-1.00|<0.0001
74023625|NCT05202808|147600114|OTHER||Odds Ratio (OR)|4.61|||||TWO_SIDED|95.0|2.97|7.15|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and Control group is the denominator. At Month 6, the odds of achieving UCDVA of 20/20 or better were 4.61 times greater for the LAL group than the Control group.|||7.15|2.97|
74023626|NCT05202808|147600115|OTHER||Odds Ratio (OR)|20.74|||||TWO_SIDED|95.0|12.05|36.14|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving Absolute MRCYL of 0.5D or less was 20.74 for the LAL group versus the Control group at month 6.|||36.14|12.05|
74023627|NCT05202808|147600116|OTHER||Odds Ratio (OR)|14.46|||||TWO_SIDED|95.0|8.89|23.57|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving simultaneous Absolute MRSE and MRCL of 0.5 D or less was 14.46 in the LAL group vs. Control at month 6.|||23.57|8.89|
74023628|NCT02747004|147600123|SUPERIORITY|||||||0.293||||||Two-sided P-value.|Log Rank|Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.||||||0.2930
74023629|NCT02747004|147600123|OTHER|Informal phase 2 non-inferiority.|Hazard Ratio (HR)|1.045|||||TWO_SIDED|95.0|0.711|1.535|||Log Rank|Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.||||1.535|0.711|
74023630|NCT01444300|147600133|SUPERIORITY_OR_OTHER|||||||0.51|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo||||0.51
74023631|NCT01444300|147600134|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo after 12 weeks.||||0.7
74023632|NCT01444300|147600135|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo||||0.8
74023633|NCT03658954|147600136|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||Testing for group effect.||||0.75
74023634|NCT03658954|147600137|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Testing for group effect.||||0.05
74023635|NCT03658954|147600138|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Testing for group effect.||||0.02
74023636|NCT00963807|147600161|SUPERIORITY_OR_OTHER|||||||0.336|||||||t-test, 2 sided|||||||0.336
73848743|NCT01119443|147242901|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.2|||||TWO_SIDED|90.0|98.3|110.3|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||110.3|98.3|
73900531|NCT01931670|147331866|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.049||0.284|TWO_SIDED|97.5|-0.16|0.06|||mixed-effects model|||Month 5||0.06|-0.16|0.284
73900532|NCT01931670|147331866|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|97.5|-0.33|-0.11|||mixed-effects model|||Month 5||-0.11|-0.33|< 0.001
73900533|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.56|-0.18|||ANOVA|||Month 1||-0.18|-0.56|< 0.001
73900534|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.84|-0.46|||ANOVA|||Month 1||-0.46|-0.84|< 0.001
73900535|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-0.82|-0.42|||ANOVA|||Month 2||-0.42|-0.82|< 0.001
73960778|NCT05061693|147457440|SUPERIORITY||Odds Ratio (OR)|7.1||||0.0061|TWO_SIDED|95.0|1.6|45.4|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||45.4|1.6|0.0061
73960779|NCT05061693|147457440|SUPERIORITY||difference in response rate|28.0|STANDARD_ERROR_OF_MEAN|9.18|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
73960780|NCT05061693|147457440|SUPERIORITY||Odds Ratio (OR)|10.2||||0.0005|TWO_SIDED|95.0|2.3|65.6|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||65.6|2.3|0.0005
73960781|NCT05061693|147457440|SUPERIORITY||difference in response rate|36.3|STANDARD_ERROR_OF_MEAN|9.42|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
73960782|NCT05061693|147457440|SUPERIORITY||Odds Ratio (OR)|16.8|||<|0.0001|TWO_SIDED|95.0|3.9|107.5|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||107.5|3.9|<0.0001
73960783|NCT05061693|147457440|SUPERIORITY||difference in response rate|48.6|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
73960784|NCT00442117|147457459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.074||||0.4982|TWO_SIDED|95.0|-4.196|2.049|||ANOVA|||||2.049|-4.196|0.4982
73960785|NCT00442117|147457460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7601||||0.6544|TWO_SIDED|95.0|-2.585|4.106|||ANOVA|||||4.106|-2.585|0.6544
73960786|NCT00442117|147457461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.704||||0.3796|TWO_SIDED|95.0|-5.528|2.115|||ANOVA|||||2.115|-5.528|0.3796
73960787|NCT00442117|147457462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.432||||0.9622|TWO_SIDED|95.0|-17.56|18.24|||ANOVA|||||18.240|-17.560|0.9622
73960788|NCT00688519|147457562|SUPERIORITY_OR_OTHER|||||||0.058|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.058
73960789|NCT00688519|147457562|SUPERIORITY_OR_OTHER|||||||0.313|||||||Breslow-Day Test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1||||0.313
73960790|NCT00688519|147457563|SUPERIORITY_OR_OTHER|||||||0.029|||||||Cochran-Mantel-Haenszel|||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.029
74023637|NCT00045032|147600164|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73848744|NCT01119443|147242902|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.8||||||90.0|100.1|109.8|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.8|100.1|
73900536|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.29|-0.89|||ANOVA|||Month 2||-0.89|-1.29|< 0.001
73900537|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.84|-0.42|||ANOVA|||Month 3||-0.42|-0.84|< 0.001
73900538|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-1.35|-0.93|||ANOVA|||Month 3||-0.93|-1.35|< 0.001
73900539|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-0.84|-0.41|||ANOVA|||Month 4||-0.41|-0.84|< 0.001
73900540|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-1.43|-1.0|||ANOVA|||Month 4||-1.00|-1.43|< 0.001
73900541|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-1.01|-0.57|||ANOVA|||Month 5||-0.57|-1.01|< 0.001
73900542|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-1.47|-1.02|||ANOVA|||Month 5||-1.02|-1.47|< 0.001
73900543|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.95|-0.49|||ANOVA|||Month 6||-0.49|-0.95|< 0.001
73900544|NCT01931670|147331867|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-1.5|-1.04|||ANOVA|||Month 6||-1.04|-1.50|< 0.001
73900545|NCT01931670|147331868|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.12||0.02|TWO_SIDED|97.5|-0.55|-0.01|||mixed-effects model|||Month 1||-0.01|-0.55|0.02
73900546|NCT01931670|147331868|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.119|<|0.001|TWO_SIDED|97.5|-0.72|-0.18|||mixed-effects model|||Month 1||-0.18|-0.72|< 0.001
73900547|NCT01931670|147331868|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-0.85|-0.23|||mixed-effects model|||Month 2||-0.23|-0.85|< 0.001
73900548|NCT01931670|147331868|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-1.27|-0.65|||mixed-effects model|||Month 2||-0.65|-1.27|< 0.001
74023638|NCT00045032|147600164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.67|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.67|0.44|
73900549|NCT01931670|147331868|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.164|<|0.001|TWO_SIDED|97.5|-0.95|-0.21|||mixed-effects model|||Month 4||-0.21|-0.95|< 0.001
74023639|NCT00045032|147600165|SUPERIORITY_OR_OTHER|||||||0|||||||Log Rank|||||||0.000
74023640|NCT00045032|147600165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.34|0.53|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.53|0.34|
74023641|NCT00045032|147600168|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74023642|NCT00045032|147600168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.67|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.67|
74023643|NCT00045032|147600168|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73900550|NCT01931670|147331868|SUPERIORITY||LS Mean of Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.164|<|0.001|TWO_SIDED|97.5|-1.72|-0.99|||mixed-effects model|||Month 4||-0.99|-1.72|< 0.001
73900551|NCT01931670|147331868|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.168|<|0.001|TWO_SIDED|97.5|-0.99|-0.23|||mixed-effects model|||Month 5||-0.23|-0.99|< 0.001
73900552|NCT01931670|147331868|SUPERIORITY||LS Mean of Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.168|<|0.001|TWO_SIDED|97.5|-1.75|-1.0|||mixed-effects model|||Month 5||-1.00|-1.75|< 0.001
73960791|NCT00688519|147457564|SUPERIORITY_OR_OTHER|||||||0.013|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.013
73960792|NCT00688519|147457565|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.008
74023644|NCT00045032|147600168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.67|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.85|0.67|
74023645|NCT00045032|147600173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.68|
74023646|NCT00045032|147600173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.69|0.87|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.87|0.69|
74023647|NCT00045032|147600180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.7962|TWO_SIDED|95.0|0.89|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.17|0.89|0.7962
74023648|NCT00045032|147600182|SUPERIORITY_OR_OTHER|||||||0.2379|||||||Log Rank|||||||0.2379
74023649|NCT00045032|147600182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.47|1.21|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||1.21|0.47|
74023650|NCT00045032|147600183|SUPERIORITY_OR_OTHER|||||||0.003|||||||Log Rank|||||||0.003
74023651|NCT00045032|147600183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.28|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.28|
74023652|NCT00045032|147600186|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Log Rank|||||||0.0005
74023653|NCT00045032|147600186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.65|0.88|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.88|0.65|
74023654|NCT00045032|147600186|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|||||||0.0001
74023655|NCT00045032|147600186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.63|0.86|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.86|0.63|
74023656|NCT00045032|147600188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.64|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.64|
74023657|NCT00045032|147600188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.62|0.83|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.83|0.62|
74023658|NCT00045032|147600190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9156|TWO_SIDED|95.0|0.84|1.21|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.21|0.84|0.9156
74023659|NCT00045032|147600192|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74023660|NCT00045032|147600192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.64|
74023661|NCT00045032|147600192|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73900553|NCT01931670|147331868|SUPERIORITY||LS Mean of Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.175|<|0.001|TWO_SIDED|97.5|-1.08|-0.3|||mixed-effects model|||Month 6||-0.30|-1.08|< 0.001
73900554|NCT01931670|147331868|SUPERIORITY||LS Mean of Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.175|<|0.001|TWO_SIDED|97.5|-1.67|-0.89|||mixed-effects model|||Month 6||-0.89|-1.67|< 0.001
73900555|NCT01931670|147331869|SUPERIORITY||Difference in LS Means|-4.2|STANDARD_ERROR_OF_MEAN|1.55||0.007|TWO_SIDED|95.0|-7.25|-1.16|||ANCOVA|||Month 1||-1.16|-7.25|0.007
73900556|NCT01931670|147331869|SUPERIORITY||Difference in LS Means|-7.55|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-10.6|-4.5|||ANCOVA|||Month 1||-4.50|-10.6|< 0.001
73900557|NCT01931670|147331869|SUPERIORITY||Difference in LS Means|-7.33|STANDARD_ERROR_OF_MEAN|1.74|<|0.001|TWO_SIDED|95.0|-10.75|-3.91|||ANCOVA|||Month 3||-3.91|-10.75|< 0.001
73900558|NCT01931670|147331869|SUPERIORITY||Difference in LS Means|-15.43|STANDARD_ERROR_OF_MEAN|1.75|<|0.001|TWO_SIDED|95.0|-18.87|-11.99|||ANCOVA|||Month 3||-11.99|-18.87|< 0.001
73900559|NCT01931670|147331869|SUPERIORITY||Difference in LS Means|-8.7|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-12.81|-4.6|||ANCOVA|||Month 6||-4.60|-12.81|< 0.001
73900560|NCT01931670|147331869|SUPERIORITY||Difference in LS Means|-16.92|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-20.98|-12.86|||ANCOVA|||Month 6||-12.86|-20.98|< 0.001
73900561|NCT01931670|147331870|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|1.95||0.77|TWO_SIDED|95.0|-4.4|3.26|||ANCOVA|||Month 1||3.26|-4.40|0.77
73900562|NCT01931670|147331870|SUPERIORITY||Difference in LS Means|-4.4|STANDARD_ERROR_OF_MEAN|1.93||0.023|TWO_SIDED|95.0|-8.19|-0.61|||ANCOVA|||Month 1||-0.61|-8.19|0.023
73900563|NCT01931670|147331870|SUPERIORITY||Difference in LS Means|-2.74|STANDARD_ERROR_OF_MEAN|2.42||0.257|TWO_SIDED|95.0|-7.5|2.01|||ANCOVA|||Month 3||2.01|-7.50|0.257
73900564|NCT01931670|147331870|SUPERIORITY||Difference in LS Means|-10.69|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-15.37|-6.01|||ANCOVA|||Month 3||-6.01|-15.37|< 0.001
73900565|NCT01931670|147331870|SUPERIORITY||Difference in LS Means|-2.93|STANDARD_ERROR_OF_MEAN|2.91||0.315|TWO_SIDED|95.0|-8.66|2.8|||ANCOVA|||Month 6||2.80|-8.66|0.315
73900566|NCT01931670|147331870|SUPERIORITY||Difference in LS Means|-14.1|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-19.64|-8.55|||ANCOVA|||Month 6||-8.55|-19.64|< 0.001
73848745|NCT01119443|147242903|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|108.31|||||TWO_SIDED|90.0|95.634|122.676|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||122.676|95.634|
73848746|NCT01119443|147242904|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|106.85|||||TWO_SIDED|90.0|93.189|122.251|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||122.251|93.189|
73848747|NCT01119443|147242905|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|98.426|||||TWO_SIDED|90.0|84.276|112.58|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.58|84.276|
73848748|NCT01119443|147242906|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|95.11|||||TWO_SIDED|90.0|82.461|109.698|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.698|82.461|
73848749|NCT01119443|147242908|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.07|||||TWO_SIDED|90.0|91.585|118.263|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||118.263|91.585|
73848750|NCT01119443|147242909|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|93.6||||||90.0|86.9|100.8|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.8|86.9|
73848751|NCT01119443|147242910|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|100.2|||||TWO_SIDED|90.0|94.0|106.7|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.7|94.0|
73848752|NCT01119443|147242911|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||TWO_SIDED|90.0|73.583|101.854|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.854|73.583|
73848753|NCT01119443|147242912|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||TWO_SIDED|90.0|73.583|101.854|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.854|73.583|
74023662|NCT00045032|147600192|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.61|
73848754|NCT01119443|147242913|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|99.069|||||TWO_SIDED|90.0|80.688|117.45|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||117.45|80.688|
73848755|NCT01119443|147242914|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|109.48|||||TWO_SIDED|90.0|89.571|133.811|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||133.811|89.571|
73848756|NCT01119443|147242916|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|92.63|||||TWO_SIDED|90.0|77.871|110.185|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||110.185|77.871|
73848757|NCT00775268|147242927|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
73848758|NCT00775268|147242928|SUPERIORITY|||||||0.0313|||||||Wilcoxon matched-pairs signed rank test|||||||0.0313
73848759|NCT01194245|147242948|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be supported if the upper limit of the two-sided 95% confidence interval for the difference between Analog-PH20 and the comparator (insulin lispro) did not exceed 0.40.|LS Means Difference|0.05||||0.2878|TWO_SIDED|95.0|-0.05|0.15|||Mixed Models Analysis|||Approximately 110 participants were to be enrolled, allowing approximately 88 participants to complete both treatment periods (44 for each investigational drug). Assuming a dropout rate of no more than 20%, intra-participant correlation of 0.80, standard deviation of 1.2, and a true difference of 0, the study would have a greater than 90% power to show that Analog-PH20 was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.||0.15|-0.05|0.2878
73848760|NCT05069649|147242976|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
73848761|NCT05069649|147242977|SUPERIORITY|||||||0.2488|||||||Fisher Exact|||||||0.2488
73848762|NCT05069649|147242978|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73848763|NCT05069649|147242979|SUPERIORITY|||||||0.32|||||||Fisher Exact|||||||0.32
73848764|NCT05069649|147242980|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
73848765|NCT05069649|147242981|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
73848766|NCT02651116|147242982|SUPERIORITY||Rate Ratio|0.7899|STANDARD_ERROR_OF_MEAN|0.0929||0.0449|TWO_SIDED|95.0|0.6273|0.9947||P-Value less than or equal to (\<=) 0.05 level was considered significantly better and P-Value lying between 0.05 less than (\<) p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per 24 hours for DXM HBr to placebo), and corresponding 95% confidence interval (CI) for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9947|0.6273|0.0449
73900567|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.43||0.019|TWO_SIDED|95.0|-1.86|-0.17|||ANCOVA|||Month 1||-0.17|-1.86|0.019
73900568|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.433||0.028|TWO_SIDED|95.0|-1.8|-0.1|||ANCOVA|||Month 1||-0.10|-1.80|0.028
73848767|NCT02651116|147242982|SUPERIORITY|||||||0.6293||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|Negative Binomial Regression|||P-value was obtained from the negative binomial model with treatment, study site (pooled), age group, log-transformed baseline average cough count per hour (based on Baseline Run-in Period) as factors, with interaction term of treatment by age group, and logarithm of the time over which the cough count was evaluated as the offset parameter.||||0.6293
73848768|NCT02651116|147242983|SUPERIORITY||Rate Ratio|0.8048|STANDARD_ERROR_OF_MEAN|0.0912||0.0552|TWO_SIDED|95.0|0.6446|1.0049||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||1.0049|0.6446|0.0552
73848769|NCT02651116|147242984|SUPERIORITY||Rate Ratio|0.9551|STANDARD_ERROR_OF_MEAN|0.1491||0.7684|TWO_SIDED|95.0|0.7032|1.2971||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||1.2971|0.7032|0.7684
73848770|NCT02651116|147242985|SUPERIORITY||Rate Ratio|0.7014|STANDARD_ERROR_OF_MEAN|0.1086||0.022|TWO_SIDED|95.0|0.5178|0.95||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9500|0.5178|0.0220
73848771|NCT02651116|147242986|SUPERIORITY||Rate Ratio|0.7454|STANDARD_ERROR_OF_MEAN|0.0848||0.0098|TWO_SIDED|95.0|0.5964|0.9316||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9316|0.5964|0.0098
73848772|NCT02651116|147242987|SUPERIORITY||Difference in least squares mean|-0.221|STANDARD_ERROR_OF_MEAN|0.1324||0.0977|TWO_SIDED|95.0|-0.4831|0.0411||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANCOVA|||Analysis of covariance (ANCOVA) model contained treatment, study site (pooled), log-transformed baseline cough time and age group terms as factors.||0.0411|-0.4831|0.0977
73848773|NCT02651116|147242988|SUPERIORITY||Difference in least squares mean|-0.2881|STANDARD_ERROR_OF_MEAN|0.1224||0.0191|TWO_SIDED|95.0|-0.5287|-0.0475||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Analysis of variance (ANOVA) model contained treatment, study site (pooled), the corresponding morning baseline cough frequency by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0475|-0.5287|0.0191
73900569|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.397||0.014|TWO_SIDED|95.0|-1.76|-0.2|||ANCOVA|||Month 2||-0.20|-1.76|0.014
73900570|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-1.44|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-2.22|-0.65|||ANCOVA|||Month 2||-0.65|-2.22|< 0.001
73900571|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.432||0.121|TWO_SIDED|95.0|-1.52|0.18|||ANCOVA|||Month 3||0.18|-1.52|0.121
73900572|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.431||0.001|TWO_SIDED|95.0|-2.25|-0.56|||ANCOVA|||Month 3||-0.56|-2.25|0.001
73900573|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-1.25|STANDARD_ERROR_OF_MEAN|0.561||0.026|TWO_SIDED|95.0|-2.35|-0.15|||ANCOVA|||Month 4||-0.15|-2.35|0.026
74023663|NCT00045032|147600194|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4755|TWO_SIDED|95.0|0.8|1.11|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.11|0.80|0.4755
74023664|NCT00045032|147600196|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74023665|NCT00045032|147600196|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.67|0.87|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.87|0.67|
74023666|NCT00045032|147600196|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74023667|NCT00045032|147600196|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.65|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.85|0.65|
73848774|NCT02651116|147242988|SUPERIORITY|||||||0.8355||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.8355
73900574|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-1.48|STANDARD_ERROR_OF_MEAN|0.555||0.008|TWO_SIDED|95.0|-2.57|-0.39|||ANCOVA|||Month 4||-0.39|-2.57|0.008
73900575|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.327||0.027|TWO_SIDED|95.0|-1.37|-0.08|||ANCOVA|||Month 5||-0.08|-1.37|0.027
73900576|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-1.11|STANDARD_ERROR_OF_MEAN|0.327|<|0.001|TWO_SIDED|95.0|-1.75|-0.47|||ANCOVA|||Month 5||-0.47|-1.75|< 0.001
73900577|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.391||0.143|TWO_SIDED|95.0|-1.34|0.2|||ANCOVA|||Month 6||0.20|-1.34|0.143
73960793|NCT00688519|147457566|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.018
73848775|NCT02651116|147242989|SUPERIORITY||Difference in least squares mean|-0.3128|STANDARD_ERROR_OF_MEAN|0.1104||0.0049|TWO_SIDED|95.0|-0.5299|-0.0956||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding morning baseline cough severity by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0956|-0.5299|0.0049
73848776|NCT02651116|147242989|SUPERIORITY|||||||0.8413||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.8413
73848777|NCT02651116|147242990|SUPERIORITY||Difference in least squares mean|-0.1483|STANDARD_ERROR_OF_MEAN|0.1337||0.2679|TWO_SIDED|95.0|-0.4112|0.1146||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding morning baseline impact on sleep by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||0.1146|-0.4112|0.2679
73848778|NCT02651116|147242990|SUPERIORITY|||||||0.2882||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.2882
73848779|NCT02651116|147242991|SUPERIORITY||Difference in least squares mean|-0.2812|STANDARD_ERROR_OF_MEAN|0.1242||0.0242|TWO_SIDED|95.0|-0.5255|-0.0369||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough frequency by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0369|-0.5255|0.0242
73848780|NCT02651116|147242991|SUPERIORITY|||||||0.2892||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), afternoon baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.2892
73848781|NCT02651116|147242992|SUPERIORITY||Difference in least squares mean|-0.3014|STANDARD_ERROR_OF_MEAN|0.1096||0.0063|TWO_SIDED|95.0|-0.517|-0.0858||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough severity by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0858|-0.5170|0.0063
73848782|NCT02651116|147242992|SUPERIORITY|||||||0.3268||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), afternoon baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.3268
73848783|NCT02651116|147242993|SUPERIORITY||Difference in least squares mean|-0.2535|STANDARD_ERROR_OF_MEAN|0.1124||0.0247|TWO_SIDED|95.0|-0.4745|-0.0325||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model with treatment, study site (pooled), the baseline assessment in child global question cold assessment by participant and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0325|-0.4745|0.0247
73960794|NCT00688519|147457567|SUPERIORITY_OR_OTHER|||||||0.167|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline||||0.167
73848784|NCT02651116|147242993|SUPERIORITY|||||||0.4093||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model with treatment, study site (pooled), baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.4093
73848785|NCT02651116|147242994|SUPERIORITY||Difference in least squares mean|0.1266|STANDARD_ERROR_OF_MEAN|0.2196||0.5652|TWO_SIDED|95.0|-0.3081|0.5614||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Participant: ANOVA model with treatment, study site (pooled), and age group included in the model.||0.5614|-0.3081|0.5652
73848786|NCT02651116|147242994|SUPERIORITY||Difference in least squares mean|-0.1368|STANDARD_ERROR_OF_MEAN|0.1982||0.4914|TWO_SIDED|95.0|-0.5292|0.2556||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Caregiver: ANOVA model with treatment, study site (pooled), and age group included in the model.||0.2556|-0.5292|0.4914
73848787|NCT02651116|147242994|SUPERIORITY|||||||0.1029||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||Participant: ANOVA model with treatment, study site (pooled), interaction of treatment by age group and age group included in the model.||||0.1029
73848788|NCT02651116|147242994|SUPERIORITY|||||||0.4736||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||Caregiver: ANOVA model with treatment, study site (pooled), interaction of treatment by age group and age group included in the model.||||0.4736
73848789|NCT01074125|147243008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3376|||<|0.0001|TWO_SIDED||||||Regression, Linear|||To assess dose ranging, the primary efficacy variable will be analyzed via a model with dose effect. Positive dose ranging confirmed if the null hypothesis of slope =0 was rejected at a significance level of 0.05||||<0.0001
73848790|NCT02706925|147243038|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2951|STANDARD_DEVIATION|0.0352|||TWO_SIDED|95.0|1.2242|1.366|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.3660|1.2242|
74023668|NCT00045032|147600198|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9626|TWO_SIDED|95.0|0.85|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.17|0.85|0.9626
73848791|NCT02706925|147243038|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.088|STANDARD_DEVIATION|0.0843|||TWO_SIDED|95.0|0.9128|1.2633|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.2633|0.9128|
73848792|NCT02706925|147243038|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.1846|STANDARD_DEVIATION|0.3328|||TWO_SIDED|95.0|0.4791|1.89|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.8900|0.4791|
73848793|NCT02706925|147243039|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2114|STANDARD_DEVIATION|0.035|||TWO_SIDED|95.0|1.1409|1.2818|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.2818|1.1409|
73848794|NCT02706925|147243039|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0771|STANDARD_DEVIATION|0.0524|||TWO_SIDED|95.0|0.9696|1.1845|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.1845|0.9696|
73848795|NCT02706925|147243039|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3969|STANDARD_DEVIATION|0.3965|||TWO_SIDED|95.0|0.5563|2.2375|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||2.2375|0.5563|
73848796|NCT04005586|147243044|OTHER|The comparison was made by descriptive statistics.||||||||||||||||Two different historical controls implanted under NCT01496066 were used.|The LAL treatment group had a mean MRCYL of -0.14 (+/- 0.21D) compared to -0.33 (+/- 0.29D) and -0.40 (+/- 0.36D) for the LAL historical control group and the monofocal IOL historical control group in NCT01496066 respectively.|||
73848797|NCT04005586|147243045|OTHER|The comparison was made by descriptive statistics.||||||||||||||||Two different historical controls implanted under NCT01496066 were used.|The LAL treatment group MRCYL change from baseline was 0.36 (+/- 0.21D) compared to 0.17 (+/- 0.29D) and 0.10 (+/- 0.36D) for the LAL historical control group and the monofocal IOL historical control group in NCT01496066, respectively.|||
73848798|NCT00120627|147243054|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|F (1,144) = 4.12, p \< .05||2 group (treatment vs. control) by 2 time (pre-intervention and post-intervention) one-way ANOVA||||<0.05
73900578|NCT01931670|147331871|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.385||0.019|TWO_SIDED|95.0|-1.67|-0.15|||ANCOVA|||Month 6||-0.15|-1.67|0.019
73900579|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.415||0.131|TWO_SIDED|95.0|-1.44|0.19|||ANCOVA|||Month 1||0.19|-1.44|0.131
73900580|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-0.85|STANDARD_ERROR_OF_MEAN|0.409||0.037|TWO_SIDED|95.0|-1.65|-0.05|||ANCOVA|||Month 1||-0.05|-1.65|0.037
74023669|NCT00045032|147600200|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73848799|NCT00120627|147243054|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
73848800|NCT00120627|147243055|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||||<0.05
73848801|NCT00120627|147243056|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||2 group (treatment vs control) by 2 time points (pre-intervention and post-intervention)||||<0.0001
73848802|NCT00120627|147243057|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
73848803|NCT00120627|147243057|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mediation using Sobel Test|||||||<0.001
73848804|NCT00120627|147243058|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
73848805|NCT00120627|147243059|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||2 group (treatment vs control) by 2 time (pre-intervention and post-intervention) ANOVA||||< 0.05
73848806|NCT00120627|147243060|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Depression Subscale||||<0.001
73848807|NCT00120627|147243060|SUPERIORITY_OR_OTHER||||||=|0.31|TWO_SIDED||||||ANOVA|||Anxiety Subscale||||=0.31
73848808|NCT00120627|147243060|SUPERIORITY_OR_OTHER||||||=|0.44|TWO_SIDED||||||ANOVA|||Somatization Subscale||||=0.44
73848809|NCT00120627|147243061|SUPERIORITY_OR_OTHER||||||=|0.66|TWO_SIDED||||||ANOVA|||Post-hoc analysis||||=0.66
73848810|NCT00120627|147243062|SUPERIORITY_OR_OTHER||||||=|0.18|TWO_SIDED||||||ANOVA|||||||= 0.18
73848811|NCT00120627|147243063|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||< 0.01
73848812|NCT02030821|147243064|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
73848813|NCT02030821|147243065|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73848814|NCT02030821|147243066|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
73848815|NCT02030821|147243067|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
73900581|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-1.12|STANDARD_ERROR_OF_MEAN|0.423||0.008|TWO_SIDED|95.0|-1.96|-0.29|||ANCOVA|||Month 2||-0.29|-1.96|0.008
73900582|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-1.44|STANDARD_ERROR_OF_MEAN|0.426|<|0.001|TWO_SIDED|95.0|-2.27|-0.6|||ANCOVA|||Month 2||-0.60|-2.27|< 0.001
74023670|NCT00045032|147600200|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.64|
74023671|NCT00045032|147600200|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74023672|NCT00045032|147600200|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.61|
74023673|NCT00045032|147600202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.45|TWO_SIDED|95.0|0.8|1.1|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.10|0.80|0.4500
74023674|NCT00045032|147600204|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74023675|NCT00045032|147600204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.62|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.62|
74023676|NCT00045032|147600204|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73900583|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.434||0.036|TWO_SIDED|95.0|-1.76|-0.06|||ANCOVA|||Month 3||-0.06|-1.76|0.036
73900584|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.431||0.035|TWO_SIDED|95.0|-1.76|-0.06|||ANCOVA|||Month 3||-0.06|-1.76|0.035
74023677|NCT00045032|147600204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.59|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.59|
73848816|NCT01911351|147243185|SUPERIORITY_OR_OTHER||kappa statistic|0.88|||<|0.001|TWO_SIDED|||||A priori threshold for statistical significance: p\< or = 0.05|Chi-squared|||A kappa statistic was performed for 75% of the group to assess inter-rater agreement of the perception of the success of the procedure.||||<0.001
73848817|NCT04683913|147243193|OTHER||||||<|0.001|||||||ANCOVA|alpha=0.05||||||<0.001
73848818|NCT04683913|147243194|OTHER|||||||0.027||||||Week 1\&2 vs Week 3\&4|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.027
73848819|NCT04683913|147243194|OTHER|||||||1||||||Week 3\&4 vs Week 5\&6|t-test, 2 sided|||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||1.0
73848820|NCT04683913|147243194|OTHER|||||||0.078||||||Week 5\&6 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.078
73848821|NCT04683913|147243194|OTHER|||||||0.015||||||Follow up vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.015
73848822|NCT04683913|147243194|OTHER|||||||0.567||||||Week 1\&2 vs Week 5\&6|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.567
73900585|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.453||0.452|TWO_SIDED|95.0|-1.23|0.55|||ANCOVA|||Month 4||0.55|-1.23|0.452
73848823|NCT04683913|147243194|OTHER|||||||0.001||||||Week 1\&2 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.001
73848824|NCT04683913|147243194|OTHER|||||||1||||||Week 1\&2 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||1.0
73848825|NCT04683913|147243194|OTHER|||||||0.205||||||Week 3\&4 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.205
73848826|NCT04683913|147243194|OTHER|||||||0.162||||||Week 3\&4 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.162
73848827|NCT04683913|147243194|OTHER|||||||0.421||||||Week 5\&6 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.421
73848828|NCT04683913|147243199|SUPERIORITY|||||||0.75|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - pain subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.750
73848829|NCT04683913|147243199|SUPERIORITY|||||||0.201|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - stiffness subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.201
73900586|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.432||0.002|TWO_SIDED|95.0|-2.18|-0.48|||ANCOVA|||Month 4||-0.48|-2.18|0.002
73900587|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-1.12|STANDARD_ERROR_OF_MEAN|0.443||0.012|TWO_SIDED|95.0|-1.99|-0.25|||ANCOVA|||Month 5||-0.25|-1.99|0.012
73900588|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-1.64|STANDARD_ERROR_OF_MEAN|0.439|<|0.001|TWO_SIDED|95.0|-2.5|-0.78|||ANCOVA|||Month 5||-0.78|-2.5|< 0.001
74023678|NCT00045032|147600206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.6823|TWO_SIDED|95.0|0.8|1.15|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.15|0.80|0.6823
74023679|NCT00045032|147600208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.7251|TWO_SIDED|95.0|0.84|1.13|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.13|0.84|0.7251
73848830|NCT04683913|147243199|SUPERIORITY|||||||0.997|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - physical function subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.997
73848831|NCT04683913|147243199|SUPERIORITY|||||||0.423|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - quality of life subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.423
73848832|NCT04683913|147243200|SUPERIORITY|||||||0.342|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee adduction moment 1 (early stance) was analyzed as raw Nm with body mass entered as as covariate.||||0.342
73848833|NCT04683913|147243200|SUPERIORITY|||||||0.844|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee Adduction Moment 2 (late stance was analyzed as raw Nm with body mass entered as as covariate.||||0.844
73848834|NCT04683913|147243200|SUPERIORITY|||||||0.774|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee Flexion Moments were analyzed as raw Nm with body mass entered as as covariate||||0.774
73848835|NCT04683913|147243201|SUPERIORITY|||||||0.186|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee adduction moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.||||0.186
73848836|NCT04683913|147243201|SUPERIORITY|||||||0.601|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee flexion moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.||||0.601
73848837|NCT00543985|147243202|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.266|||=|0.14|TWO_SIDED|95.0|||||Regression, Linear|||Pearson Product correlation was used to determine relationships between resting E/E' and Exercise VO2 max and Stress E/E' and Exercise VO2max.||||=0.14
73848838|NCT03848455|147243213|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP2CA gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
73900589|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.478||0.13|TWO_SIDED|95.0|-1.67|0.21|||ANCOVA|||Month 6||0.21|-1.67|0.13
73900590|NCT01931670|147331872|SUPERIORITY||Difference in LS Means|-1.45|STANDARD_ERROR_OF_MEAN|0.454||0.001|TWO_SIDED|95.0|-2.34|-0.56|||ANCOVA|||Month 6||-0.56|-2.34|0.001
73900591|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-1.34|STANDARD_ERROR_OF_MEAN|1.01||0.186|TWO_SIDED|95.0|-3.32|0.65|||ANCOVA|||Month 1||0.65|-3.32|0.186
73900592|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-3.09|STANDARD_ERROR_OF_MEAN|1.013||0.002|TWO_SIDED|95.0|-5.08|-1.1|||ANCOVA|||Month 1||-1.10|-5.08|0.002
73900593|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-1.31|STANDARD_ERROR_OF_MEAN|1.005||0.195|TWO_SIDED|95.0|-3.28|0.67|||ANCOVA|||Month 2||0.67|-3.28|0.195
73900594|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-3.65|STANDARD_ERROR_OF_MEAN|1.007|<|0.001|TWO_SIDED|95.0|-5.63|-1.67|||ANCOVA|||Month 2||-1.67|-5.63|< 0.001
73900595|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-2.03|STANDARD_ERROR_OF_MEAN|1.02||0.047|TWO_SIDED|95.0|-4.03|-0.02|||ANCOVA|||Month 3||-0.02|-4.03|0.047
73900596|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-3.2|STANDARD_ERROR_OF_MEAN|1.021||0.002|TWO_SIDED|95.0|-5.21|-1.19|||ANCOVA|||Month 3||-1.19|-5.21|0.002
73900597|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|0.998||0.103|TWO_SIDED|95.0|-3.59|0.33|||ANCOVA|||Month 4||0.33|-3.59|0.103
73900598|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-4.78|STANDARD_ERROR_OF_MEAN|0.99|<|0.001|TWO_SIDED|95.0|-6.72|-2.83|||ANCOVA|||Month 4||-2.83|-6.72|< 0.001
73900599|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-2.29|STANDARD_ERROR_OF_MEAN|0.97||0.019|TWO_SIDED|95.0|-4.2|-0.38|||ANCOVA|||Month 5||-0.38|-4.20|0.019
73900600|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-5.14|STANDARD_ERROR_OF_MEAN|0.975|<|0.001|TWO_SIDED|95.0|-7.06|-3.22|||ANCOVA|||Month 5||-3.22|-7.06|< 0.001
73900601|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|1.112||0.383|TWO_SIDED|95.0|-3.16|1.22|||ANCOVA|||Month 6||1.22|-3.16|0.383
73900602|NCT01931670|147331873|SUPERIORITY||Difference in LS Means|-3.02|STANDARD_ERROR_OF_MEAN|1.092||0.006|TWO_SIDED|95.0|-5.17|-0.87|||ANCOVA|||Month 6||-0.87|-5.17|0.006
73900603|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.422||0.975|TWO_SIDED|95.0|-0.81|0.84|||ANCOVA|||Month 1||0.84|-0.81|0.975
73900604|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|-0.02|STANDARD_ERROR_OF_MEAN|0.415||0.969|TWO_SIDED|95.0|-0.83|0.8|||ANCOVA|||Month 1||0.80|-0.83|0.969
73900605|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|-0.22|STANDARD_ERROR_OF_MEAN|0.389||0.569|TWO_SIDED|95.0|-0.99|0.54|||ANCOVA|||Month 2||0.54|-0.99|0.569
73900606|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.393||0.311|TWO_SIDED|95.0|-1.17|0.37|||ANCOVA|||Month 2||0.37|-1.17|0.311
73900607|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|0.43|STANDARD_ERROR_OF_MEAN|0.505||0.398|TWO_SIDED|95.0|-0.56|1.42|||ANCOVA|||Month 3||1.42|-0.56|0.398
73900608|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.505||0.761|TWO_SIDED|95.0|-1.15|0.84|||ANCOVA|||Month 3||0.84|-1.15|0.761
73900609|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|0.08|STANDARD_ERROR_OF_MEAN|0.491||0.874|TWO_SIDED|95.0|-0.89|1.04|||ANCOVA|||Month 4||1.04|-0.89|0.874
73900610|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|-0.93|STANDARD_ERROR_OF_MEAN|0.468||0.048|TWO_SIDED|95.0|-1.85|-0.01|||ANCOVA|||Month 4||-0.01|-1.85|0.048
73900611|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.635||0.16|TWO_SIDED|95.0|-2.14|0.35|||ANCOVA|||Month 5||0.35|-2.14|0.16
73900612|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|-0.9|STANDARD_ERROR_OF_MEAN|0.63||0.152|TWO_SIDED|95.0|-2.14|0.33|||ANCOVA|||Month 5||0.33|-2.14|0.152
73900613|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.498||0.095|TWO_SIDED|95.0|-1.81|0.15|||ANCOVA|||Month 6||0.15|-1.81|0.095
74023680|NCT00473694|147600212|SUPERIORITY||Estimated Treatment Effect|17.29|||<|0.0001|TWO_SIDED|95.0|13.95|21.42||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.42|13.95|<0.0001
74023681|NCT00473694|147600213|SUPERIORITY||Estimated Treatment Effect|14.86|||<|0.0001|TWO_SIDED|95.0|10.18|21.67||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.67|10.18|<0.0001
74023682|NCT00473694|147600214|SUPERIORITY||Estimated Treatment Effect|15.84|||<|0.0001|TWO_SIDED|95.0|12.58|19.95||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||19.95|12.58|<0.0001
74023683|NCT00473694|147600215|SUPERIORITY||Estimated Treatment Effect|18.45|||<|0.0001|TWO_SIDED|95.0|13.98|24.35||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||24.35|13.98|<0.0001
74023684|NCT00473694|147600216|SUPERIORITY||Estimated Treatment Effect|17.04|||<|0.0001|TWO_SIDED|95.0|13.62|21.31||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.31|13.62|<0.0001
74023685|NCT00473694|147600217|SUPERIORITY||Estimated Treatment Effect|17.7|||<|0.0001|TWO_SIDED|95.0|12.85|24.38||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||24.38|12.85|<0.0001
73900614|NCT01931670|147331874|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.474||0.071|TWO_SIDED|95.0|-1.79|0.07|||ANCOVA|||Month 6||0.07|-1.79|0.071
74023686|NCT05224258|147600232|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.2|||<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.1|-0.4|<0.001
73900615|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-1.83|STANDARD_ERROR_OF_MEAN|1.106||0.098|TWO_SIDED|95.0|-4.01|0.34|||ANCOVA|||Month 1||0.34|-4.01|0.098
73900616|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-3.72|STANDARD_ERROR_OF_MEAN|1.113|<|0.001|TWO_SIDED|95.0|-5.91|-1.54|||ANCOVA|||Month 1||-1.54|-5.91|< 0.001
73900617|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-2.02|STANDARD_ERROR_OF_MEAN|1.091||0.065|TWO_SIDED|95.0|-4.16|0.13|||ANCOVA|||Month 2||0.13|-4.16|0.065
73900618|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-5.1|STANDARD_ERROR_OF_MEAN|1.089|<|0.001|TWO_SIDED|95.0|-7.24|-2.96|||ANCOVA|||Month 2||-2.96|-7.24|< 0.001
73900619|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-2.65|STANDARD_ERROR_OF_MEAN|1.14||0.02|TWO_SIDED|95.0|-4.89|-0.41|||ANCOVA|||Month 3||-0.41|-4.89|0.02
73900620|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-4.64|STANDARD_ERROR_OF_MEAN|1.135|<|0.001|TWO_SIDED|95.0|-6.87|-2.41|||ANCOVA|||Month 3||-2.41|-6.87|< 0.001
73900621|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-2.72|STANDARD_ERROR_OF_MEAN|1.138||0.017|TWO_SIDED|95.0|-4.95|-0.48|||ANCOVA|||Month 4||-0.48|-4.95|0.017
73900622|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-6.27|STANDARD_ERROR_OF_MEAN|1.124|<|0.001|TWO_SIDED|95.0|-8.48|-4.06|||ANCOVA|||Month 4||-4.06|-8.48|< 0.001
73900623|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-2.49|STANDARD_ERROR_OF_MEAN|1.095||0.023|TWO_SIDED|95.0|-4.64|-0.34|||ANCOVA|||Month 5||-0.34|-4.64|0.023
73900624|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-5.83|STANDARD_ERROR_OF_MEAN|1.095|<|0.001|TWO_SIDED|95.0|-7.98|-3.68|||ANCOVA|||Month 5||-3.68|-7.98|< 0.001
73900625|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|1.264||0.311|TWO_SIDED|95.0|-3.77|1.2|||ANCOVA|||Month 6||1.20|-3.77|0.311
73900626|NCT01931670|147331875|SUPERIORITY||Difference in LS Means|-3.97|STANDARD_ERROR_OF_MEAN|1.241||0.001|TWO_SIDED|95.0|-6.42|-1.53|||ANCOVA|||Month 6||-1.53|-6.42|0.001
73900627|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.62||0.335|TWO_SIDED|95.0|-1.81|0.62|||ANCOVA|||Month 1||0.62|-1.81|0.335
73900628|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-0.72|STANDARD_ERROR_OF_MEAN|0.611||0.242|TWO_SIDED|95.0|-1.91|0.48|||ANCOVA|||Month 1||0.48|-1.91|0.242
73900629|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.652||0.042|TWO_SIDED|95.0|-2.61|-0.05|||ANCOVA|||Month 2||-0.05|-2.61|0.042
73900630|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-1.77|STANDARD_ERROR_OF_MEAN|0.656||0.007|TWO_SIDED|95.0|-3.06|-0.48|||ANCOVA|||Month 2||-0.48|-3.06|0.007
73900631|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.71||0.503|TWO_SIDED|95.0|-1.87|0.92|||ANCOVA|||Month 3||0.92|-1.87|0.503
73960795|NCT00688519|147457567|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline||||0.009
73900632|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|0.707||0.169|TWO_SIDED|95.0|-2.36|0.41|||ANCOVA|||Month 3||0.41|-2.36|0.169
73900633|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.737||0.675|TWO_SIDED|95.0|-1.76|1.14|||ANCOVA|||Month 4||1.14|-1.76|0.675
73900634|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-2.17|STANDARD_ERROR_OF_MEAN|0.703||0.002|TWO_SIDED|95.0|-3.55|-0.79|||ANCOVA|||Month 4||-0.79|-3.55|0.002
73900635|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-2.04|STANDARD_ERROR_OF_MEAN|0.856||0.017|TWO_SIDED|95.0|-3.72|-0.36|||ANCOVA|||Month 5||-0.36|-3.72|0.017
73900636|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-2.54|STANDARD_ERROR_OF_MEAN|0.848||0.003|TWO_SIDED|95.0|-4.21|-0.87|||ANCOVA|||Month 5||-0.87|-4.21|0.003
73900637|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-1.59|STANDARD_ERROR_OF_MEAN|0.778||0.042|TWO_SIDED|95.0|-3.12|-0.06|||ANCOVA|||Month 6||-0.06|-3.12|0.042
73900638|NCT01931670|147331876|SUPERIORITY||Difference in LS Means|-2.28|STANDARD_ERROR_OF_MEAN|0.738||0.002|TWO_SIDED|95.0|-3.73|-0.83|||ANCOVA|||Month 6||-0.83|-3.73|0.002
73960796|NCT04036058|147457576|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
73960797|NCT04036058|147457577|SUPERIORITY|||||||0.0435|||||||t-test, 2 sided|||||||0.0435
73960798|NCT04036058|147457578|SUPERIORITY|||||||0.1158|||||||t-test, 2 sided|||||||0.1158
73960799|NCT04036058|147457579|SUPERIORITY|||||||0.0898|||||||t-test, 2 sided|||||||0.0898
73960800|NCT04036058|147457580|SUPERIORITY|||||||0.114|||||||t-test, 2 sided|||||||0.114
73960801|NCT03351075|147457587|SUPERIORITY||Mean Difference (Net)|-1.31||||0.5163|TWO_SIDED|95.0|-5.28|2.65||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||The sample size was based on comparing the changes for the primary outcome measure (PDI-DLV) at 12 months after surgery. The calculation was based on comparing the values at 12 months. Assuming a coefficient of variation (CV) equal to 0.5, 87 participants per group were needed based on a two-sample pooled t-test of a mean ratio with lognormal data and α=0.05 to detect with 80% power a difference of 20% in PDI. To anticipate a drop-out ratio of 5%, a total of 184 subjects were needed.||2.65|-5.28|0.5163
73960802|NCT03351075|147457588|SUPERIORITY||Mean Difference (Net)|-0.97||||0.5655|TWO_SIDED|95.0|-4.26|2.33||No corrections for multiple testing were performed.|multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain-related disability from baseline to 4 months||2.33|-4.26|0.5655
73960803|NCT03351075|147457588|SUPERIORITY||Mean Difference (Net)|-1.07||||0.5592|TWO_SIDED|95.0|-4.64|2.51||P\<.05 was considered significant. No corrections for multiple testing were performed.|multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain-related disability from baseline to 1.5 years||2.51|-4.64|0.5592
73960804|NCT03351075|147457589|SUPERIORITY||Mean Difference (Net)|-2.23||||0.563|TWO_SIDED|95.0|-9.84|5.37||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 4 months||5.37|-9.84|0.5630
73960805|NCT03351075|147457589|SUPERIORITY||Mean Difference (Net)|-4.3||||0.2524|TWO_SIDED|95.0|-11.68|3.09||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 12 months||3.09|-11.68|0.2524
73900639|NCT01198158|147331896|SUPERIORITY|||||||0.739|||||||Log Rank|OS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors.||||||0.739
73900640|NCT01198158|147331897|SUPERIORITY|||||||0.832|||||||Log Rank|PFS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors||||||0.832
73900641|NCT01063712|147331905|SUPERIORITY_OR_OTHER||||||<|0.01|||||||percentage|||It is not a analysis of two groups. Only one group of patients was analyzed.||||<0.01
73900642|NCT01063712|147331906|SUPERIORITY_OR_OTHER||||||<|0.01|||||||percentage|The analysis was made on the basis of the percentage of patients with completely regressed dilation.||It is a one arm clinical study. No comparison between groups was made.||||<0.01
73900643|NCT00246571|147331908|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.203||||0.8885|TWO_SIDED|95.0|0.8889|1.628||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from the interactive voice response system (IVRS).|Log Rank|||For core radiology laboratory assessment||1.6280|0.8889|0.8885
73960806|NCT03351075|147457589|SUPERIORITY||Mean Difference (Net)|-4.8||||0.2315|TWO_SIDED|95.0|-12.69|3.09|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 1.5 years||3.09|-12.69|0.2315
73960807|NCT03351075|147457590|SUPERIORITY||Mean Difference (Net)|0.47||||0.7494|TWO_SIDED|95.0|-2.39|3.32||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported central sensitisation symptoms from baseline to 4 months.||3.32|-2.39|0.7494
73900644|NCT00246571|147331908|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1598||||0.8472|TWO_SIDED|95.0|0.8703|1.5457||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from IVRS.|Log Rank|||For investigator's assessment||1.5457|0.8703|0.8472
73900645|NCT00246571|147331909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.9624|TWO_SIDED|95.0|0.06|1.71||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Core radiology laboratory assessment||1.71|0.06|0.9624
73848839|NCT03848455|147243213|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of SYNJ1 gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
73848840|NCT03848455|147243213|OTHER|||||||0.149|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP3CB gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||0.149
73848841|NCT03848455|147243213|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of NSF gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
73848842|NCT04046939|147243216|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.2283|||<|0.0001|TWO_SIDED|95.0|0.121|0.431||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||0.2283 represents the ratio of the 150 mg BID week 12 ratio to baseline (0.2051), compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.2283 is equivalent to a -77.17% change compared to placebo at week 12.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.431|0.121|<.0001
73900646|NCT00246571|147331909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.814|TWO_SIDED|95.0|0.27|1.98||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Investigator's assessment||1.98|0.27|0.8140
73900647|NCT00246571|147331912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1599||||0.8394|TWO_SIDED|95.0|0.8648|1.5558||One-sided log rank test stratified for the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Log Rank||Hazard ratio for sunitinib versus standard of care.|||1.5558|0.8648|0.8394
73900648|NCT03390842|147331934|SUPERIORITY||Difference in % of subjects|24.9|||=|0.0015|TWO_SIDED|95.0|10.2|38.7|||Fisher Exact|||% Subjects Who Met Endpoint (≥ 4 mEq/L Change from Baseline Serum Bicarbonate or Serum Bicarbonate in the Normal Range \[22 - 29 mEq/L\]): TRC101-Placebo||38.7|10.2|= 0.0015
73960808|NCT03351075|147457590|SUPERIORITY||Mean Difference (Net)|-0.25||||0.8617|TWO_SIDED|95.0|-3.09|2.58|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||The difference in change in self-reported central sensitisation symptoms from baseline to 12 months.||2.58|-3.09|0.8617
73960809|NCT03351075|147457590|SUPERIORITY||Mean Difference (Net)|-0.29||||0.8454|TWO_SIDED|95.0|-3.16|2.59|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported central sensitisation symptoms from baseline to 1.5 years||2.59|-3.16|0.8454
73960810|NCT03351075|147457591|SUPERIORITY||Mean Difference (Net)|1.35||||0.3463|TWO_SIDED|95.0|0.72|2.51|||multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 4 months||2.51|0.72|0.3463
73960811|NCT03351075|147457591|SUPERIORITY||Mean Difference (Net)|0.86||||0.6613|TWO_SIDED|95.0|0.451|1.66|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 1 year||1.66|0.451|0.6613
73960812|NCT03351075|147457591|SUPERIORITY||Mean Difference (Net)|1.26||||0.4908|TWO_SIDED|95.0|0.65|2.42|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 1.5 years||2.42|0.65|0.4908
73960813|NCT03351075|147457592|SUPERIORITY||Mean Difference (Net)|0.22||||0.7708|TWO_SIDED|95.0|-1.25|1.69|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in warmth detection sensitivity from baseline to 4 months||1.69|-1.25|0.7708
73960814|NCT03351075|147457592|SUPERIORITY||Mean Difference (Net)|0.29||||0.706|TWO_SIDED|95.0|-1.23|1.81|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in warmth detection sensitivity from baseline to 1 year||1.81|-1.23|0.7060
73960815|NCT03351075|147457592|SUPERIORITY||Mean Difference (Net)|0.02||||0.9806|TWO_SIDED|95.0|-1.38|1.42|||Multivariate linear model|||Difference in change in warmth detection sensitivity from baseline to 1.5 years||1.42|-1.38|0.9806
73960816|NCT03351075|147457593|SUPERIORITY||Mean Difference (Net)|0.74||||0.0284|TWO_SIDED|95.0|0.08|1.4|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 4 months||1.40|0.08|0.0284
73848843|NCT04046939|147243216|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.3403||||0.0014|TWO_SIDED|95.0|0.177|0.653||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||0.3403 represents the ratio of the 75 mg BID week 12 ratio to baseline (0.3056), compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.3403 is equivalent to a -65.97% change compared to placebo at week 12.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.653|0.177|0.0014
73900649|NCT03390842|147331934|SUPERIORITY||Treatment difference in % of subjects|24.4|||=|0.0015|TWO_SIDED|95.0|9.7|38.2|||Fisher Exact|||% Subjects with ≥ 4mEq/L Change from Baseline in Serum Bicarbonate: TRC101-Placebo||38.2|9.7|= 0.0015
73960817|NCT03351075|147457593|SUPERIORITY||Mean Difference (Net)|0.09||||0.7776|TWO_SIDED|95.0|-0.55|0.73|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 1 year||0.73|-0.55|0.7776
73960818|NCT03351075|147457593|SUPERIORITY||Mean Difference (Net)|0.31||||0.3829|TWO_SIDED|95.0|-0.39|1.01|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 1.5 years||1.01|-0.39|0.3829
73960819|NCT03351075|147457594|SUPERIORITY||Mean Difference (Net)|0.31||||0.1948|TWO_SIDED|95.0|-0.16|0.77|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in conditioned pain modulation from baseline to 4 months||0.77|-0.16|0.1948
73960820|NCT03351075|147457594|SUPERIORITY||Mean Difference (Net)|0.17||||0.4937|TWO_SIDED|95.0|-0.31|0.65|||Multivariate linear model|||Difference in change in conditioned pain modulation from baseline to 1 year||0.65|-0.31|0.4937
73900650|NCT03390842|147331934|SUPERIORITY||Treatment difference in % of subjects|30.2|||<|0.0001|TWO_SIDED|95.0|15.6|43.7|||Fisher Exact|||% Subjects with Serum Bicarbonate in Normal Range (22 - 29 mEq/L): TRC101-Placebo||43.7|15.6|< 0.0001
73900651|NCT03390842|147331935|SUPERIORITY||Treatment difference in LS means|1.99|STANDARD_ERROR_OF_MEAN|0.524|=|0.0002|TWO_SIDED|95.0|0.96|3.03|||Mixed-effect repeated measures model||Standard error presented above is for the LS mean.|Least Squares Mean Change from Baseline: TRC101-Placebo||3.03|0.96|= 0.0002
73900652|NCT03390842|147331936|SUPERIORITY||||||<|0.0001||||||p-value based on analysis of covariance model with rank of change from baseline in total score as dependent variable; treatment (PBO or TRC101) as a fixed effect; and baseline total score, Baseline eGFR, Baseline Bicarbonate as continuous covariates.|ANCOVA|||Mean Change from Baseline in KDQOL-PFD: TRC101-Placebo||||< 0.0001
73960821|NCT03351075|147457594|SUPERIORITY||Mean Difference (Net)|0.23||||0.369|TWO_SIDED|95.0|-0.27|0.73|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in conditioned pain modulation from baseline to 1.5 years||0.73|-0.27|0.3690
73960822|NCT03351075|147457595|SUPERIORITY||Mean Difference (Net)|2.24||||0.2915|TWO_SIDED|95.0|-1.94|6.43|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 4 months||6.43|-1.94|0.2915
73900653|NCT03390842|147331937|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from Baseline for Repeated Chair Stand Test: TRC101-Placebo||||< 0.0001
73900654|NCT03702244|147331938|SUPERIORITY|Statistical testing for recurrent events was performed using the negative binomial methods for recurrent events.|Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.2|0.41|||Log Rank||Hazard ratio was adjusted for age, sex, and coronary artery disease equivalent (diabetes, history of peripheral artery disease or cerebrovascular disease), and intended first test strata (invasive or noninvasive).|Sample size and power calculations for this study are based on the hypothesis that the precision evaluation arm is superior to the usual care arm on the time-to-first event of the composite 3-component endpoint: all-cause death, non-fatal MI, or invasive cardiac catheterization without obstructive CAD over a 12-month of follow-up. Time to event analysis will use the date of the event, including the date of catheterization at which the absence of obstructive CAD is demonstrated.||0.41|0.20|<.001
73960823|NCT03351075|147457595|SUPERIORITY||Mean Difference (Net)|-1.63||||0.4632|TWO_SIDED|95.0|-6.02|2.75|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 1 year||2.75|-6.02|0.4632
73960824|NCT03351075|147457595|SUPERIORITY||Mean Difference (Net)|-3.16||||0.1944|TWO_SIDED|95.0|-7.94|1.63|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 1,5 years||1.63|-7.94|0.1944
73960825|NCT03351075|147457596|SUPERIORITY||Mean Difference (Net)|-293.0||||0.5332|TWO_SIDED|95.0|-1218.0|632.0|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in step count from baseline to 4 months||632|-1218|0.5332
73960826|NCT03351075|147457596|SUPERIORITY||Mean Difference (Net)|839.0||||0.1201|TWO_SIDED|95.0|-221.0|1900.0|||Multivariate linear model|||Difference in change in step count from baseline to 1 year||1900|-221|0.1201
73960827|NCT03351075|147457597|SUPERIORITY||Mean Difference (Net)|0.831||||0.359|TWO_SIDED|95.0|0.561|1.233|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 4 months||1.233|0.561|0.3590
73960828|NCT03351075|147457597|SUPERIORITY||Mean Difference (Net)|0.839||||0.3744|TWO_SIDED|95.0|0.57|1.236|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 1 year||1.236|0.570|0.3744
73960829|NCT03351075|147457597|SUPERIORITY||Median Difference (Net)|0.848||||0.4533|TWO_SIDED|95.0|0.522|1.304|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 1.5 years||1.304|0.522|0.4533
73960830|NCT03351075|147457598|SUPERIORITY||Mean Difference (Net)|0.862||||0.5018|TWO_SIDED|95.0|0.558|1.33|||MUltivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 4 months||1.330|0.558|0.5018
73848844|NCT04046939|147243216|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.4489||||0.019|TWO_SIDED|95.0|0.231|0.874||A closed hierarchical statistical testing was used. The previous endpoint in the hierarchy was not statistically significant. Therefore, this endpoint was not formally tested and is not considered statistically significant, despite a p-value \<0.05.|Mixed Models Analysis||0.4489 represents the ratio of the 37.5 mg BID week 12 ratio to baseline (0.4031) compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.4489 is equivalent to a -55.11% change compared to placebo at week 12.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.874|0.231|0.0190
73848845|NCT04046939|147243217|SUPERIORITY||Mean Difference (Final Values)|0.0814||||0.4154|TWO_SIDED|95.0|-0.116|0.279||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||Estimate is the difference of the pooled 75 mg and 150 mg BID group from placebo in change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The combined 75 mg and 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.279|-0.116|0.4154
73848846|NCT04046939|147243217|SUPERIORITY||Mean Difference (Final Values)|0.177||||0.1174|TWO_SIDED|95.0|-0.0456|0.4||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.400|-0.0456|0.1174
73848847|NCT04046939|147243217|SUPERIORITY||Mean Difference (Final Values)|-0.0143||||0.8998|TWO_SIDED|95.0|-0.24|0.211||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.211|-0.240|0.8998
73848848|NCT04046939|147243217|SUPERIORITY||Mean Difference (Final Values)|0.138||||0.2425|TWO_SIDED|95.0|-0.095|0.37||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.370|-0.0950|0.2425
73848849|NCT04046939|147243218|SUPERIORITY||Mean Difference (Final Values)|-0.264||||0.3059|TWO_SIDED|95.0|-0.772|0.245||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.245|-0.772|0.3059
73848850|NCT04046939|147243218|SUPERIORITY||Mean Difference (Final Values)|-0.0457||||0.8642|TWO_SIDED|95.0|-0.575|0.484||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.484|-0.575|0.8642
73848851|NCT04046939|147243218|SUPERIORITY||Mean Difference (Final Values)|-0.0276||||0.9182|TWO_SIDED|95.0|-0.56|0.505||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.505|-0.560|0.9182
73848852|NCT04046939|147243219|SUPERIORITY||Mean Difference (Final Values)|0.181||||0.0716|TWO_SIDED|95.0|-0.0163|0.378||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 150 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.||0.378|-0.0163|0.0716
73900655|NCT00713310|147331948|SUPERIORITY_OR_OTHER||High-Low Dose Difference Success Rates|-1.1||||0.924|TWO_SIDED|95.0|-22.7|20.5|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.||20.5|-22.7|0.9240
73900656|NCT00713310|147331949|SUPERIORITY_OR_OTHER||High-Low Dose Difference Success Rates|1.4||||0.8193|TWO_SIDED|95.0|-20.2|23.0|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.||23.0|-20.2|0.8193
73900657|NCT00708201|147331987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.773|||<|0.0001|TWO_SIDED|95.0|1.359|2.311|||Wald's Chi-Square|||||2.311|1.359|<0.0001
73900658|NCT00708201|147331988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.7|||<|0.001|TWO_SIDED|95.0|-37.8|-11.5|||Log Rank|||||-11.5|-37.8|<0.001
73900659|NCT00708201|147331989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.4|||<|0.001|TWO_SIDED|95.0|-35.0|-9.9|||Log Rank|||||-9.9|-35.0|<0.001
73900660|NCT00708201|147331990|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73900661|NCT00708201|147331991|SUPERIORITY_OR_OTHER||Relative Risk|1.38|||<|0.01|TWO_SIDED|95.0|1.12|1.71|||Fisher Exact||This is the relative risk for being a responder (alvimopan/placebo).|||1.71|1.12|<0.01
73900662|NCT00708201|147331992|SUPERIORITY_OR_OTHER||Percent difference|-20.71|||<|0.001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for overall POM is presented.||||<0.001
73900663|NCT00708201|147331993|SUPERIORITY_OR_OTHER||Percent difference|27.05|||<|0.0001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.||||<0.0001
73900664|NCT00708201|147331994|SUPERIORITY_OR_OTHER||Percent difference|25.2|||<|0.0001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.||||<0.0001
73900665|NCT00708201|147331995|SUPERIORITY_OR_OTHER||Percent difference|-6.94||||0.0946|TWO_SIDED|95.0|-14.5|0.62|||Fisher Exact||Percent difference = alvimopan - placebo.|||0.62|-14.5|0.0946
73900666|NCT01653132|147331996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.194|STANDARD_DEVIATION|0.61|||TWO_SIDED|95.0|-0.71|0.32|||||negative values correspond to a reduction in saliva weight with Inco-A.|Based on the primary outcome measure of mean reduction in saliva weight at 1 month post Inco-A /placebo as compared to baseline, using paired t-test with a two-sided nominal significance (alpha) of 0.05, assuming a correlation of 0.5 between observations, a sample size of 10 pairs has a power of 0.803 to detect a 50% difference in salivary weight.||0.32|-0.71|
73900667|NCT01653132|147331997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.3|STANDARD_DEVIATION|0.34|||TWO_SIDED|95.0|-50.8|6.2|||||negative numbers represent reduction in saliva weight with Inco-A|||6.2|-50.8|
73900668|NCT01653132|147331998|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.33|STANDARD_DEVIATION|1.41|||TWO_SIDED|95.0|-1.16|0.69|||||negative values represent reduction in scores (improvement in drooling) with Inco-A|||0.69|-1.16|
73900669|NCT01653132|147331999|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.333|||||TWO_SIDED|95.0|-0.633|0.071||||||||0.071|-0.633|
73900670|NCT01653132|147332000|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.11|||||TWO_SIDED|95.0|-0.46|0.28||||||||0.28|-0.46|
73900671|NCT03312751|147332002|SUPERIORITY||Overall response rate|62.9||||0.0053|TWO_SIDED|95.0|44.9|78.5|||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||78.5|44.9|0.0053
73900672|NCT03312751|147332002|SUPERIORITY|||||||0.2839|||||||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||||0.2839
73900673|NCT03312751|147332002|SUPERIORITY|||||||0.0031|||||||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||||0.0031
73900674|NCT03490981|147332020|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.486|TWO_SIDED||||||ANCOVA|||||||.486
73900675|NCT03490981|147332021|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|1.16||0.342|TWO_SIDED||||||ANCOVA|||||||.342
73900676|NCT03490981|147332022|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|1.31||0.646|TWO_SIDED||||||ANCOVA|||||||.646
73900677|NCT03490981|147332023|SUPERIORITY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|0.205||0.205|TWO_SIDED||||||ANCOVA|||||||.205
73900678|NCT03490981|147332024|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|2.94||0.492|TWO_SIDED||||||ANCOVA|||||||.492
73900679|NCT03490981|147332025|SUPERIORITY||Mean Difference (Final Values)|4.31|STANDARD_ERROR_OF_MEAN|3.84||0.272|TWO_SIDED||||||ANCOVA|||||||.272
73900680|NCT03490981|147332026|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|4.82||0.87|TWO_SIDED||||||ANCOVA|||||||.870
73900681|NCT03490981|147332027|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.67||0.57|TWO_SIDED||||||ANCOVA|||||||.570
73900682|NCT00282464|147332038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.0056
73900683|NCT00282464|147332038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.0866
73900684|NCT00282464|147332038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0568||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0568
73900685|NCT00282464|147332038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.0130
73900686|NCT00282464|147332038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0188||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0188
73900687|NCT00282464|147332038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6394||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6394
73900688|NCT00282464|147332038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7707||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7707
74023687|NCT05224258|147600232|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.5% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint.|||-0.2|-0.5|<0.001
74023688|NCT05224258|147600233|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 65.3% with a margin of 7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|65.7|||<|0.001|TWO_SIDED|95.0|63.5|67.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||67.9|63.5|<0.001
74023689|NCT05224258|147600233|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 73.7% with a margin of 7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.1|||<|0.001|TWO_SIDED|95.0|75.4|78.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||78.9|75.4|<0.001
74023690|NCT05224258|147600234|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) will be estimated and compared to a threshold of 0.71% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.3|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.4|0.3|<0.001
74023691|NCT05224258|147600234|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) will be estimated and compared to a threshold of 0.86% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.3|||<|0.001|TWO_SIDED|95.0|0.2|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.4|0.2|<0.001
74023692|NCT05224258|147600235|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 65.3% and a significance level of 0.025 (one-sided).|Mean of Final Value|65.7||||0.208|TWO_SIDED|95.0|63.5|67.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||67.9|63.5|0.208
73848853|NCT04046939|147243219|SUPERIORITY||Mean Difference (Final Values)|0.00474||||0.9619|TWO_SIDED|95.0|-0.192|0.202||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 75 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.||0.202|-0.192|0.9619
73848854|NCT04046939|147243219|SUPERIORITY||Median Difference (Final Values)|0.0987||||0.3368|TWO_SIDED|95.0|-0.105|0.302||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 37.5 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.||0.302|-0.105|0.3368
73848855|NCT04046939|147243220|SUPERIORITY||Mean Difference (Final Values)|0.208||||0.4512|TWO_SIDED|95.0|-0.338|0.755||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 150 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.||0.755|-0.338|0.4512
73848856|NCT04046939|147243220|SUPERIORITY||Mean Difference (Final Values)|-0.0642||||0.8214|TWO_SIDED|95.0|-0.627|0.499||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 75 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.||0.499|-0.627|0.8214
73900689|NCT00282464|147332039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2185||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.2185
73900690|NCT00282464|147332039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4124||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.4124
73900691|NCT00282464|147332039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6098||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6098
73848857|NCT04046939|147243220|SUPERIORITY||Mean Difference (Final Values)|0.154||||0.5894|TWO_SIDED|95.0|-0.411|0.72||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 37.5 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.||0.720|-0.411|0.5894
74023693|NCT05224258|147600235|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 73.7% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.1|||<|0.001|TWO_SIDED|95.0|75.4|78.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||78.9|75.4|<0.001
73848858|NCT04046939|147243226|SUPERIORITY|||||||0.0196||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 150 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.0196
73848859|NCT04046939|147243226|SUPERIORITY|||||||0.0207||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 75mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.0207
73848860|NCT04046939|147243226|SUPERIORITY|||||||0.5399||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 37.5 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.5399
73848861|NCT04046939|147243227|SUPERIORITY||Mean Difference (Final Values)|-0.0233||||0.0084|TWO_SIDED|95.0|-0.0405|-0.00613||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||-0.00613|-0.0405|0.0084
73848862|NCT04046939|147243227|SUPERIORITY||Mean Difference (Final Values)|-0.0206||||0.0237|TWO_SIDED|95.0|-0.0384|-0.00281||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||-0.00281|-0.0384|0.0237
73848863|NCT04046939|147243227|SUPERIORITY||Mean Difference (Final Values)|-0.00215||||0.814|TWO_SIDED|95.0|-0.0203|0.016||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||0.0160|-0.0203|0.8140
73848864|NCT04046939|147243228|SUPERIORITY||Mean Difference (Final Values)|-8.24||||0.1886|TWO_SIDED|95.0|-20.6|4.13||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||4.13|-20.6|0.1886
73900692|NCT00282464|147332040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.0005
74023694|NCT01381094|147600236|SUPERIORITY||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|0.24|1.35||||||||1.35|0.24|
73848865|NCT04046939|147243228|SUPERIORITY||Mean Difference (Final Values)|-6.53||||0.3061|TWO_SIDED|95.0|-19.1|6.08||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 75mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||6.08|-19.1|0.3061
73848866|NCT04046939|147243228|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.1294|TWO_SIDED|95.0|-23.4|3.04||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||3.04|-23.4|0.1294
73848867|NCT00806260|147243233|NON_INFERIORITY_OR_EQUIVALENCE|step down test|Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.07|||ONE_SIDED|90.0|0.21||||ANCOVA|||at alcohol level 0.10%|||0.21|
73848868|NCT00806260|147243233|NON_INFERIORITY_OR_EQUIVALENCE|step down test|Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.05|||ONE_SIDED|90.0|0.12||||ANCOVA|||at alcohol level 0.07%|||0.12|
74023695|NCT01381094|147600236|SUPERIORITY||Mean Difference (Net)|0.76|||||TWO_SIDED|95.0|0.2|1.33||||||||1.33|0.20|
73848869|NCT00806260|147243233|NON_INFERIORITY_OR_EQUIVALENCE|step-down test|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.06|||ONE_SIDED|90.0|-0.03||||ANCOVA|||at alcohol level 0.04%|||-0.03|
73848870|NCT00806260|147243234|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.17|0.07|||ANCOVA|||at 2 hr timepoint||0.07|-0.17|
73848871|NCT00806260|147243234|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority test|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.18|0.04|||ANCOVA|||at 6 hr timepoint||0.04|-0.18|
73848872|NCT00806260|147243234|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||at 2 hr timepoint||0.06|-0.08|
73848873|NCT00806260|147243234|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.13|0.05|||ANCOVA|||at 6 hr timepoint||0.05|-0.13|
73848874|NCT00237042|147243255|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Regression, Linear|Linear regression was used to compare group means at follow up, adjusted for baseline values of the outcome variable.||The null hypothesis was that mean characteristic pain intensity at 6-month follow up is equal across the three groups.||||0.19
73900693|NCT00282464|147332040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.0099
73900694|NCT00282464|147332040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0423||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0423
73900695|NCT00282464|147332040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0618||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.0618
73900696|NCT00282464|147332040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0451||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0451
73900697|NCT00282464|147332040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2633||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.2633
73900698|NCT00282464|147332040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2206||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.2206
73900699|NCT00282464|147332041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9863||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.9863
73900700|NCT00282464|147332041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1017||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.1017
74023696|NCT01381094|147600236|SUPERIORITY||Mean Difference (Net)|1.28|||||TWO_SIDED|95.0|0.73|1.83||||||||1.83|0.73|
73848875|NCT00237042|147243256|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Regression, Logistic|Adjusted for baseline value of the outcome variable||||||0.27
73848876|NCT00237042|147243257|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Regression, Linear|Group means compared with linear regression adjusted for baseline values. Adjusted difference: -1.0 between SMT and COCT, -1.0 between TSMT and COCT.||The null hypothesis was that mean characteristic pain intensity at 12-month follow up is equal across the three groups.||||0.003
73848877|NCT00237042|147243258|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Regression, Logistic|Adjusted for baseline value of the outcome variable||||||0.016
73848878|NCT01897532|147243259|NON_INFERIORITY|The non-inferiority margin was chosen as 1.3 (FDA Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes).|Hazard Ratio (HR)|1.02||||0.0002|TWO_SIDED|95.0|0.89|1.17||p-value for Hazard ratio (HR) ≥1.3 (1-sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.17|0.89|0.0002
73848879|NCT01897532|147243259|OTHER||Hazard Ratio (HR)|1.02||||0.6301|TWO_SIDED|95.0|0.89|1.17||p-value for HR ≥1.0 (1-sided).|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.17|0.89|0.6301
73848880|NCT01897532|147243260|OTHER||Hazard Ratio (HR)|1.04||||0.6918|TWO_SIDED|95.0|0.89|1.22||p-value for HR ≥1.0 (1-sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.22|0.89|0.6918
73848881|NCT03682965|147243263|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
73900701|NCT00282464|147332041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4033||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.4033
73900702|NCT00282464|147332042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||No multiple comparison adjustment is applicable. Statistical significance level was 0.05|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.002
73900703|NCT00282464|147332042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.019
73900704|NCT00282464|147332042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.038
73900705|NCT00282464|147332042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.069
73900706|NCT00282464|147332042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.053
73900707|NCT00282464|147332042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0. The null hypotheses is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups.||||0.154
73900708|NCT00282464|147332042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.007
73900709|NCT00282464|147332043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.112||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.112
73900710|NCT00282464|147332043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.352
73900711|NCT00282464|147332043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.873
73900712|NCT00282464|147332044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.305
73900713|NCT00282464|147332044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.510
73900714|NCT00282464|147332044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.710
73900715|NCT00282464|147332045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.026
73900716|NCT00282464|147332045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.223
73900717|NCT00282464|147332045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.848||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.848
73900718|NCT00282464|147332046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.381
73900719|NCT00282464|147332046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.676||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.676
73900720|NCT00282464|147332046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.295
73900721|NCT00282464|147332047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.068
73960831|NCT03351075|147457598|SUPERIORITY||Mean Difference (Net)|0.808||||0.3362|TWO_SIDED|95.0|0.522|1.248|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 1 year||1.248|0.522|0.3362
73900722|NCT00282464|147332047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.043
73900723|NCT00282464|147332047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.404||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.404
73900724|NCT00282464|147332048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.899
73900725|NCT00282464|147332048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.739
73900726|NCT00282464|147332048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.797||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.797
73900727|NCT00282464|147332049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.434
73900728|NCT00282464|147332049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.777||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.777
73900729|NCT00282464|147332049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.820
73900730|NCT00282464|147332050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.468||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.468
73900731|NCT00282464|147332050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.110
73900732|NCT00282464|147332050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.738
73900733|NCT00282464|147332050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.617
73900734|NCT00282464|147332050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.642||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.642
73960832|NCT03351075|147457598|SUPERIORITY||Mean Difference (Net)|0.958||||0.8375|TWO_SIDED|95.0|0.633|1.449|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 1.5 years||1.449|0.633|0.8375
73960833|NCT03351075|147457599|SUPERIORITY||Mean Difference (Net)|-0.32||||0.1745|TWO_SIDED|95.0|-0.78|0.14|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 4 months||0.14|-0.78|0.1745
73960834|NCT03351075|147457599|SUPERIORITY||Mean Difference (Net)|0.18||||0.5025|TWO_SIDED|95.0|-0.35|0.71|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 1 year||0.71|-0.35|0.5025
73960835|NCT03351075|147457599|SUPERIORITY||Mean Difference (Net)|0.45||||0.1363|TWO_SIDED|95.0|-0.14|1.05|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 1,5 years||1.05|-0.14|0.1363
73960836|NCT03351075|147457600|SUPERIORITY||Percentage|-0.184||||0.074|TWO_SIDED|95.0|-0.358|0.008|||Fisher Exact|||Difference in proportion of working participants at 1 year||0.008|-0.358|0.074
73960837|NCT03351075|147457600|SUPERIORITY||Percentage|-0.09||||0.352|TWO_SIDED|95.0|-0.26|0.078|||Fisher Exact|||Difference in proportion of working participants at 1,5 years||0.078|-0.26|0.352
73960838|NCT03351075|147457601|SUPERIORITY||Mean Difference (Net)|0.23||||0.8497|TWO_SIDED|95.0|-2.17|2.64|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 4 months||2.64|-2.17|0.8497
73960839|NCT03351075|147457601|SUPERIORITY||Mean Difference (Net)|0.81||||0.4971|TWO_SIDED|95.0|-1.52|3.14|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 1 year||3.14|-1.52|0.4971
73960840|NCT03351075|147457601|SUPERIORITY||Mean Difference (Net)|0.45||||0.6831|TWO_SIDED|95.0|-1.72|2.62|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 1.5 years||2.62|-1.72|0.6831
73900735|NCT00282464|147332050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.644||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.644
74023697|NCT01381094|147600236|SUPERIORITY||Mean Difference (Net)|1.45|||||TWO_SIDED|95.0|0.91|2.0||||||||2.00|0.91|
73900736|NCT00282464|147332050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.789||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.789
73960841|NCT03351075|147457602|SUPERIORITY||Mean Difference (Net)|4.78||||0.8584|TWO_SIDED|95.0|-47.72|57.28|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 4 months||57.28|-47.72|0.8584
73960842|NCT03351075|147457602|SUPERIORITY||Mean Difference (Net)|-57.25||||0.0353|TWO_SIDED|95.0|-110.57|-3.93|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 1 year||-3.93|-110.57|0.0353
73960843|NCT03351075|147457602|SUPERIORITY||Mean Difference (Net)|-20.1||||0.4865|TWO_SIDED|95.0|-76.72|36.52|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 1.5 years||36.52|-76.72|0.4865
73960844|NCT03351075|147457603|SUPERIORITY||Mean Difference (Net)|1.11||||0.1278|TWO_SIDED|95.0|0.97|1.27|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 4 months||1.27|0.97|0.1278
73960845|NCT03351075|147457603|SUPERIORITY||Mean Difference (Net)|1.11||||0.1875|TWO_SIDED|95.0|0.95|1.3|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1 year||1.30|0.95|0.1875
73960846|NCT03351075|147457603|SUPERIORITY||Mean Difference (Net)|1.05||||0.5612|TWO_SIDED|95.0|0.89|1.23|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1.5 years||1.23|0.89|0.5612
73960847|NCT03351075|147457604|SUPERIORITY||Mean Difference (Net)|1.089||||0.7902|TWO_SIDED|95.0|0.693|1.62|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 4 months||1.620|0.693|0.7902
73960848|NCT03351075|147457604|SUPERIORITY||Mean Difference (Net)|0.934||||0.7578|TWO_SIDED|95.0|0.604|1.443|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 1 year||1.443|0.604|0.7578
73960849|NCT03351075|147457604|SUPERIORITY||Mean Difference (Net)|1.01||||0.96|TWO_SIDED|95.0|0.679|1.504|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 1.5 years||1.504|0.679|0.9600
73960850|NCT03351075|147457605|SUPERIORITY||Mean Difference (Net)|1.068||||0.7619|TWO_SIDED|95.0|0.696|1.639|||Multivariate linear model|multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 4 months||1.639|0.696|0.7619
73900737|NCT00282464|147332051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.042
73900738|NCT00282464|147332051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.088
73900739|NCT00282464|147332051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.651||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.651
73900740|NCT00282464|147332051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.665
73900741|NCT00282464|147332051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.349
73960851|NCT03351075|147457605|SUPERIORITY||Mean Difference (Net)|1.087||||0.7169|TWO_SIDED|95.0|0.702|1.673|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 1 year||1.673|0.702|0.7169
73900742|NCT00282464|147332051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.685
73960852|NCT03351075|147457605|SUPERIORITY||Mean Difference (Net)|0.987||||0.9535|TWO_SIDED|95.0|0.639|1.525|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 1.5 years||1.525|0.639|0.9535
73960853|NCT04603924|147457621|OTHER||||||||||||||||||"For the analysis of this efficacy endpoint, missing scores of the WHO Ordinal Scale for Clinical Improvement will be assumed to be \> 2 (i.e., no hospital discharge). Median time-to-clinical improvement and corresponding 95% confidence interval were estimated from the Kaplan-Meier curves. In some cases the 95% confidence interval was Not Evaluable (NE) by this method."|||
74023698|NCT01381094|147600236|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
73900743|NCT00282464|147332051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.257||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.257
73900744|NCT00282464|147332052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 1||||0.0099
73900745|NCT00282464|147332052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 2||||0.0654
73900746|NCT00282464|147332052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1807||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 3||||0.1807
73900747|NCT00282464|147332052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0957||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 4||||0.0957
73900748|NCT00282464|147332052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0752||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 5||||0.0752
73900749|NCT00282464|147332052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3964||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 6||||0.3964
73900750|NCT00282464|147332052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Overall||||0.0287
73900751|NCT00282464|147332053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.965||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint||||0.965
73960854|NCT04603924|147457622|OTHER||||||||||||||||||"For the analysis of this efficacy endpoint, missing scores of the WHO Ordinal Scale for Clinical Improvement were be assumed to be \> 2 (i.e., no hospital discharge). Median number of days to a 2-point improvement and corresponding 95% confidence interval were estimated from the Kaplan-Meier curves.~In some cases the 95% confidence interval was Not Evaluable (NE) by this method."|||
73900752|NCT00282464|147332054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint||||0.860
73900753|NCT00282464|147332055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Baseline to endpoint||||0.428
73900754|NCT00282464|147332056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status||Change from baseline to endpoint||||0.708
73900755|NCT00282464|147332057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.898||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.898
73900756|NCT00282464|147332058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.559||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint||||0.559
73900757|NCT00282464|147332059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458||||||For all secondary efficacy analyses, no multiple adjustments were made|ANOVA|ANVOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint||||0.458
73900758|NCT04391569|147332086|OTHER|||||||0||||||P-value from logistic regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|P-value is derived by fixed weight (2/3 for interim and 1/3 for post interim) combination test.||||||0.0000
73900759|NCT04391569|147332087|OTHER|||||||0.1619||||||P-value from logistics regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|P-value is derive by fixed weight (2/3 for interim and 1/3 for post interim) combination test.||||||0.1619
73960855|NCT02139046|147457636|SUPERIORITY_OR_OTHER||Difference in Proportions|25.6|||<|0.001|TWO_SIDED|95.0|20.4|30.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the Cui, Hung, and Wang (CHW) Z-test which accounts for the interim analysis.||||30.9|20.4|<0.001
73900760|NCT04391569|147332089|OTHER|||||||0.2097|||||||fixed weight combination test|||||||0.2097
73900761|NCT04391569|147332090|OTHER|||||||0|||||||Log Rank|||||||0.0000
73900762|NCT04391569|147332091|OTHER|||||||0.0075||||||P-value is derived by fixed weight (2/3 for interim and 1/3 for post interim) combination test. P-value from logistics regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|||||||0.0075
73900763|NCT00899392|147332096|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Student's t test|t-test, 2 sided|||||||<0.0001
73900764|NCT00899392|147332097|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Mann Whitney Test-non parametric||||>0.05
73900765|NCT00899392|147332098|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|paired||||||>0.05
73900766|NCT00899392|147332099|SUPERIORITY_OR_OTHER|||||||0.0053||95.0|||||t-test, 2 sided|||||||0.0053
73900767|NCT02387476|147332120|NON_INFERIORITY|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|1.13|<|0.001|TWO_SIDED|95.0|-1.7|2.9||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP\<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean AHI is rounded to a single decimal point in the text of the report (3.0 and 2.4, respectively), in order to be consistent with standard reporting of AHI.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.||2.9|-1.7|<0.001
73900768|NCT02387476|147332121|NON_INFERIORITY|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.36|<|0.001|TWO_SIDED|95.0|-0.4|1.0||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP\<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean ODI values are rounded to a single decimal point value in the text of the table (1.4 and 1.1, respectively) to ensure consistency with ODI reporting standards.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.||1.0|-0.4|<0.001
73900769|NCT04721067|147332153|SUPERIORITY||Mean Difference (Net)|-2.27||||0.607|TWO_SIDED|95.0|-15.14|10.6|||Regression, Logistic|Adjusted for baseline values||||10.60|-15.14|0.607
73900770|NCT04721067|147332154|SUPERIORITY||Mean Difference (Net)|-2.99||||0.766|TWO_SIDED|95.0|-10.74|4.76|||ANCOVA|||||4.76|-10.74|0.766
73900771|NCT04721067|147332155|SUPERIORITY||Mean Difference (Net)|145.54||||0.465|TWO_SIDED|95.0|-264.05|555.14|||ANCOVA|||||555.14|-264.05|0.465
73900772|NCT04721067|147332156|SUPERIORITY||Mean Difference (Net)|137.79||||0.178|TWO_SIDED|95.0|-68.71|344.3|||ANCOVA|||||344.30|-68.71|0.178
73900773|NCT04721067|147332157|SUPERIORITY||Mean Difference (Net)|1.87||||0.548|TWO_SIDED|95.0|-4.58|8.31|||ANCOVA|||||8.31|-4.58|0.548
73900774|NCT04721067|147332158|SUPERIORITY||Mean Difference (Net)|-0.67||||0.579|TWO_SIDED|95.0|-3.14|1.8|||ANCOVA|||||1.80|-3.14|0.579
73900775|NCT04721067|147332159|SUPERIORITY||Mean Difference (Net)|-0.63||||0.766|TWO_SIDED|95.0|-5.0|3.74|||ANCOVA|||||3.74|-5.00|0.766
73900776|NCT04721067|147332160|SUPERIORITY||Mean Difference (Net)|-1.23||||0.42|TWO_SIDED|95.0|-4.39|1.93|||ANCOVA|||||1.93|-4.39|0.42
73900777|NCT04721067|147332161|SUPERIORITY||Mean Difference (Net)|-0.07||||0.91|TWO_SIDED|95.0|-1.34|1.2|||ANCOVA|||||1.20|-1.34|0.91
73900778|NCT04721067|147332162|SUPERIORITY||Mean Difference (Net)|0.79||||0.73|TWO_SIDED|95.0|-4.03|5.6|||ANCOVA|||||5.60|-4.03|0.73
73900779|NCT04721067|147332163|SUPERIORITY||Mean Difference (Net)|0.19||||0.42|TWO_SIDED|95.0|-0.3|0.68|||ANCOVA|||||0.68|-0.30|0.42
73900780|NCT04721067|147332164|SUPERIORITY||Mean Difference (Net)|1.79||||0.18|TWO_SIDED|95.0|-0.9|4.48|||ANCOVA|||||4.48|-0.90|0.18
73900781|NCT04721067|147332165|SUPERIORITY||Mean Difference (Net)|-2.03||||0.48|TWO_SIDED|95.0|-7.97|3.9|||ANCOVA|||||3.90|-7.97|0.48
73900782|NCT04721067|147332166|SUPERIORITY||Mean Difference (Net)|1.42||||0.08|TWO_SIDED|95.0|-0.24|3.08|||ANCOVA|||||3.08|-0.24|0.08
73900783|NCT04721067|147332167|SUPERIORITY||Mean Difference (Net)|0.51||||0.94|TWO_SIDED|95.0|-13.5|14.52|||ANCOVA|||||14.52|-13.50|0.94
73900784|NCT04721067|147332170|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.32|TWO_SIDED|95.0|-0.45|1.32|||t-test, 2 sided|||||1.32|-0.45|0.32
73900785|NCT04721067|147332171|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.61|TWO_SIDED|95.0|-0.75|1.25|||t-test, 2 sided|||||1.25|-0.75|0.61
74023699|NCT01381094|147600237|SUPERIORITY||||||=|0.9355|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.9355
73900786|NCT04721067|147332172|SUPERIORITY||Mean Difference (Net)|-1.05||||0.52|TWO_SIDED|95.0|-4.42|2.31|||ANCOVA|||||2.31|-4.42|0.52
73900787|NCT04721067|147332173|SUPERIORITY||Mean Difference (Net)|-0.44||||0.61|TWO_SIDED|95.0|-2.2|1.32|||ANCOVA|||||1.32|-2.20|0.61
73900788|NCT04721067|147332174|SUPERIORITY||Mean Difference (Net)|3.68||||0.16|TWO_SIDED|95.0|-1.61|8.97|||ANCOVA|||||8.97|-1.61|0.16
73900789|NCT04721067|147332175|SUPERIORITY||Mean Difference (Net)|0.43||||0.13|TWO_SIDED|95.0|-0.13|1.0|||ANCOVA|||||1.00|-0.13|0.13
73900790|NCT04721067|147332176|SUPERIORITY||Mean Difference (Net)|3.88||||0.03|TWO_SIDED|95.0|0.35|7.41|||ANCOVA|||||7.41|0.35|0.03
73900791|NCT04721067|147332177|SUPERIORITY||Mean Difference (Net)|-3.2||||0.41|TWO_SIDED|95.0|-11.07|4.66|||ANCOVA|||||4.66|-11.07|0.41
74023700|NCT01381094|147600237|SUPERIORITY||||||=|0.6594|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.6594
74023701|NCT01381094|147600237|SUPERIORITY||||||=|0.0203|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0203
73960856|NCT02139046|147457636|SUPERIORITY_OR_OTHER||Difference in Proportions|49.8|||<|0.001|TWO_SIDED|95.0|43.9|55.8||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||55.8|43.9|<0.001
73960857|NCT02139046|147457636|SUPERIORITY_OR_OTHER||Difference in Proportions|10.2||||0.001|TWO_SIDED|95.0|3.5|17.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||17.0|3.5|0.001
73960858|NCT02139046|147457636|SUPERIORITY_OR_OTHER||Difference in Proportions|7.5||||0.043|TWO_SIDED|95.0|-0.8|15.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||15.9|-0.8|0.043
73960859|NCT02139046|147457637|SUPERIORITY_OR_OTHER||Difference in Proportions|2.1||||0.503|TWO_SIDED|95.0|-4.9|9.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||9.0|-4.9|0.503
73960860|NCT02139046|147457637|SUPERIORITY_OR_OTHER||Difference in Proportions|5.9||||0.064|TWO_SIDED|95.0|-1.2|13.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||13.0|-1.2|0.064
73960861|NCT02139046|147457637|SUPERIORITY_OR_OTHER||Difference in Proportions|1.8||||0.561|TWO_SIDED|95.0|-5.1|8.7||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||8.7|-5.1|0.561
73960862|NCT02139046|147457637|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.5||||0.869|TWO_SIDED|95.0|-8.0|6.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||6.9|-8.0|0.869
73960863|NCT02139046|147457638|SUPERIORITY_OR_OTHER||Difference in Proportions|47.6|||<|0.001|TWO_SIDED|95.0|41.6|53.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||53.6|41.6|<0.001
73960864|NCT02139046|147457638|SUPERIORITY_OR_OTHER||Difference in Proportions|60.5|||<|0.001|TWO_SIDED|95.0|54.6|66.3||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||66.3|54.6|<0.001
73960865|NCT02139046|147457638|SUPERIORITY_OR_OTHER||Difference in Proportions|7.8||||0.036|TWO_SIDED|95.0|-0.5|16.1||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||16.1|-0.5|0.036
73960866|NCT02139046|147457638|SUPERIORITY_OR_OTHER||Difference in Proportions|3.3||||0.364|TWO_SIDED|95.0|-4.9|11.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||11.6|-4.9|0.364
73960867|NCT03675581|147457641|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|101.36|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|92.83|110.67|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||110.67|92.83|
73960868|NCT03675581|147457642|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|96.4|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|91.48|101.58|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T = Test, R = Reference|||101.58|91.48|
73960869|NCT03675581|147457643|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|116.69|STANDARD_DEVIATION|12.6|||TWO_SIDED|90.0|107.63|126.51|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||126.51|107.63|
74023702|NCT01381094|147600237|SUPERIORITY||||||=|0.0369|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0369
73960870|NCT03675581|147457644|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|100.89|STANDARD_DEVIATION|18.1|||TWO_SIDED|90.0|89.9|113.23|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||113.23|89.90|
73900792|NCT04721067|147332178|SUPERIORITY||Mean Difference (Net)|1.7||||0.17|TWO_SIDED|95.0|-0.83|4.22|||ANCOVA|||||4.22|-0.83|0.17
73900793|NCT04721067|147332179|SUPERIORITY||Mean Difference (Net)|3.49||||0.58|TWO_SIDED|95.0|-9.58|16.55|||ANCOVA|||||16.55|-9.58|0.58
73900794|NCT04721067|147332180|SUPERIORITY||Mean Difference (Net)|0.15||||0.74|TWO_SIDED|95.0|-0.79|1.1|||ANCOVA|||||1.10|-0.79|0.74
73900795|NCT04721067|147332181|SUPERIORITY||Mean Difference (Net)|129.077||||0.17|TWO_SIDED|95.0|-57.78|315.92|||ANCOVA|||||315.92|-57.78|0.17
73900796|NCT04721067|147332182|SUPERIORITY||Mean Difference (Net)|109.71||||0.31|TWO_SIDED|95.0|-108.37|327.78|||ANCOVA|||||327.78|-108.37|0.31
73960871|NCT03675581|147457645|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|101.24|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|93.95|109.1|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||109.10|93.95|
73960872|NCT03675581|147457646|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|88.09|STANDARD_DEVIATION|15.0|||TWO_SIDED|90.0|80.03|96.96|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||96.96|80.03|
74023703|NCT01381094|147600237|SUPERIORITY|p-value was based on the comparison within treatment group (Change from Baseline to Week 1).|||||=|0.3713|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.3713
74023704|NCT01381094|147600237|SUPERIORITY||||||=|0.163|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1630
74023705|NCT01381094|147600237|SUPERIORITY||||||=|0.7615|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7615
74084723|NCT03653026|147722716|SUPERIORITY||Adjusted Response Rate Difference|37.0|||<|0.001|TWO_SIDED|95.0|28.8|45.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||45.1|28.8|<0.001
73900797|NCT04721067|147332183|SUPERIORITY||Mean Difference (Net)|0.24||||0.92|TWO_SIDED|95.0|-4.52|5.0|||ANCOVA|||||5.00|-4.52|0.92
73900798|NCT04721067|147332184|SUPERIORITY||Mean Difference (Net)|-1.11||||0.66|TWO_SIDED|95.0|-6.28|4.06|||ANCOVA|||||4.06|-6.28|0.66
73900799|NCT02233478|147332185|OTHER||Mean Difference (Final Values)|0.001||||0.82|TWO_SIDED||||||t-test, 2 sided|||"Comparison of ellagic acid concentration 0 to 24 hours post-dose area under the curve was made to PJ alone vs. PJ with soy protein after intervention.~Due to the quality issue of soybean flour, data from this intervention group was not analyzed."||||0.82
73900800|NCT02216812|147332188|OTHER|||||||0.63|||||||Regression, Linear|||We tested the null hypothesis that there is no difference in DPC six weeks after fracture of the distal radius between patients taking vitamin C and placebo.||||0.63
73900801|NCT00873873|147332193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||ANOVA|||Is there a difference in airway wall thickness among the 4 groups?||||0.2
73900802|NCT00604214|147332236|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.088||||0.313|TWO_SIDED|95.0|0.923|1.283||No adjustment for multiple comparisons.|Chi-squared|||The study was planned to have 80% power to detect a 20% relative risk reduction in 28-day all-cause mortality in drotrecogin alpha (activated) compared to placebo. The final power was 75% because of the lower than anticipated placebo mortality.||1.283|0.923|0.313
73900803|NCT00604214|147332237|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.54|TWO_SIDED|95.0|0.737|1.173||No adjustments for multiple comparisons.|Chi-squared|||||1.173|0.737|0.540
73960873|NCT01113931|147457647|SUPERIORITY_OR_OTHER||Difference in Percent Cure Rates|0.3|||||TWO_SIDED|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.||5.1|-4.6|
73960874|NCT01113931|147457650|SUPERIORITY_OR_OTHER||Difference in Percent Cure Rates|0.2|||||TWO_SIDED|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.||5.1|-4.6|
73900804|NCT00604214|147332238|SUPERIORITY_OR_OTHER|||||||0.181||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.181
73900805|NCT00604214|147332239|SUPERIORITY_OR_OTHER|||||||0.733||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.733
73900806|NCT00604214|147332240|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.122
73900807|NCT00604214|147332241|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.042||||0.556|TWO_SIDED|95.0|0.909|1.193||No adjustments for multiple comparisons.|Chi-squared|||||1.193|0.909|0.556
73900808|NCT00604214|147332242|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.758|TWO_SIDED|95.0|0.898|1.16||No adjustments for multiple comparisons.|Chi-squared|||||1.160|0.898|0.758
73900809|NCT00604214|147332244|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA|||||||0.788
73900810|NCT00604214|147332244|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA|||||||0.730
73900811|NCT00604214|147332244|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA|||||||0.662
73848882|NCT03682965|147243264|SUPERIORITY||||||<|0.05||||||The Holm-Bonferroni correction for multiple tests was used because the two outcomes are based on correlated data.|Clopper-Pearson binomial exact test|||The secondary efficacy endpoint was the percentage of days during peak pollen season for which the average total combined score was lower in the immunotherapy group than in the placebo group.||||<0.05
73848883|NCT03682965|147243266|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
73848884|NCT04472650|147243304|OTHER||Ratio of Geometric Least Squares Means|87.63|||||TWO_SIDED|90.0|78.273|98.111||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||98.111|78.273|
73848885|NCT04472650|147243305|OTHER||Ratio of Geometric Least Squares Means|87.5|||||TWO_SIDED|90.0|78.12|98.01||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||98.01|78.12|
73848886|NCT04472650|147243306|OTHER||Ratio of Geometric Least Squares Means|88.8|||||TWO_SIDED|90.0|77.41|101.87||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||101.87|77.41|
73848887|NCT01861665|147243322|SUPERIORITY|||||||0.8379||||||Pre Incision vs. Post Incision on Post op day 0.|t-test, 2 sided|||||||0.8379
73848888|NCT01861665|147243322|SUPERIORITY|||||||0.7263||||||Pre incision vs. Post incision post op day 1.|t-test, 2 sided|||||||0.7263
73900812|NCT00604214|147332244|SUPERIORITY_OR_OTHER|||||||0.846||95.0||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA|||||||0.846
73900813|NCT00604214|147332245|SUPERIORITY_OR_OTHER|||||||0.697||95.0||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA|||||||0.697
73900814|NCT00604214|147332245|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA|||||||0.306
73900815|NCT00604214|147332245|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA|||||||0.645
73900816|NCT00604214|147332245|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA|||||||0.690
73900817|NCT00604214|147332246|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||P-value is for physical component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.482
73900818|NCT00604214|147332246|SUPERIORITY_OR_OTHER|||||||0.584||95.0||||P-value is for physical component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.584
73848889|NCT01861665|147243322|SUPERIORITY|||||||0.5||||||Pre incision vs. Post incision day 2.|t-test, 2 sided|||||||0.5
73848890|NCT01669902|147243344|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Change at Month 3||||<0.0001
73848891|NCT01669902|147243344|SUPERIORITY_OR_OTHER|||||||0.0357|TWO_SIDED||||||Wilcoxon signed rank test|||Change at Month 6||||0.0357
73848892|NCT01047189|147243348|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Kruskal-Wallis|||||||0.05
73848893|NCT00512278|147243438|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated||||||0.718|||||||t-test, 2 sided|||||||0.718
73848894|NCT00512278|147243440|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated.||||||0.718|TWO_SIDED|95.0||||Univariate and multivariable logistic regression were used for factors associated with an SVR.|t-test, 2 sided|||SVR was the primary outcome to calculate sample size. Assuming a 25% difference in the rate of SVR between the the two groups, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated. This analysis included patients randomized and received at least one dose of study drugs. A 2-sided probability value of \< 0.05 was considered statistically significant. Univariate and multivariable logistic regression were used for factors associated with an SVR.||||0.718
73848895|NCT00589797|147243471|NON_INFERIORITY|The trial was designed as a non-inferiority trial with a margin (delta) of 15%. Additional analyses using a delta of 10% as requested by FDA were also conducted.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 1 sided|||||||<0.05
73848896|NCT01881009|147243480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73848897|NCT01881009|147243481|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73848898|NCT01061385|147243486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5||||0.2922|TWO_SIDED|95.0|-6.8|21.7|||t-test, 1 sided|||||21.7|-6.8|0.2922
73848899|NCT01061385|147243487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|||||TWO_SIDED|95.0|-37.7|38.0|||||The 95% CI range above is calculated for the current estimated value.|||38.0|-37.7|
73848900|NCT00533429|147243509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.469||||||P-value (one-tailed) was calculated based on the un-stratified log-rank test.|Log Rank|||||||0.469
73848901|NCT00533429|147243510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.462||||||95% confidence interval based on normal approximation to the binomial distribution. P-value (2-tailed) calculation based on unadjusted, normal-distribution approximation for the difference in rates.|Fisher Exact|||||||0.462
73848902|NCT00533429|147243511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492||||||P-value (two-tailed) was calculated based on the un-stratified log-rank test.|Log Rank|||||||0.492
73900819|NCT00604214|147332246|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value is for physical component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.164
73900820|NCT00604214|147332246|SUPERIORITY_OR_OTHER|||||||0.666||95.0||||P-value is for physical component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.666
73900821|NCT00604214|147332246|SUPERIORITY_OR_OTHER|||||||0.786||95.0||||P-value is for mental component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.786
74023706|NCT01381094|147600237|SUPERIORITY||||||=|0.004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0040
73900822|NCT00604214|147332246|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is for mental component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.160
73900823|NCT00604214|147332246|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||P-value is for mental component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.696
73960875|NCT00071799|147457652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED|95.0|||||Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||"A 95% CI range value of 'does not exist' is not accommodated in the results table, so all the 95% CI range values are offered here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 9.8 and high range of 17.0 months."||||0.0001
73960876|NCT00071799|147457652|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58||||0.0002|TWO_SIDED|95.0|0.43|0.77|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.77|0.43|0.0002
74023707|NCT01381094|147600237|SUPERIORITY||||||=|0.0003|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0003
73848903|NCT03800030|147243529|SUPERIORITY|||||||0.031|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.305||||||0.031
73848904|NCT03800030|147243530|SUPERIORITY|||||||0.935|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 0.083||||||0.935
73848905|NCT03800030|147243531|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 1.833||||||0.040
73848906|NCT03800030|147243532|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 2.174||||||0.020
73848907|NCT03800030|147243533|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = -0.623||||||0.540
73900824|NCT00604214|147332246|SUPERIORITY_OR_OTHER|||||||0.966||95.0||||P-value is for mental component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.966
73900825|NCT00604214|147332247|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||P-value is for participants with ≥1 event. No adjustments for multiple comparisons.|Fisher Exact|||||||0.758
73900826|NCT00604214|147332248|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||Unadjusted for multiple comparisons.|Fisher Exact|||||||0.154
74023708|NCT01381094|147600237|SUPERIORITY||||||=|0.3978|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.3978
73848908|NCT03800030|147243534|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.989||||||0.007
73848909|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|2.11||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR4521||||0.010
73848910|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|0.56||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR107||||0.010
73848911|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|2.57||||0.018|TWO_SIDED||||||t-test, 2 sided|||miR-891a||||0.018
73848912|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|0.88||||0.021|TWO_SIDED||||||t-test, 2 sided|||miR363||||0.021
73848913|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|-1.0||||0.028|TWO_SIDED||||||t-test, 2 sided|||miR1248||||0.028
73848914|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|-0.85||||0.033|TWO_SIDED||||||t-test, 2 sided|||miR944||||0.033
73848915|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|2.13||||0.034|TWO_SIDED||||||t-test, 2 sided|||miR6806||||0.034
73848916|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|0.39||||0.036|TWO_SIDED||||||t-test, 2 sided|||miR103a||||0.036
73848917|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|1.69||||0.037|TWO_SIDED||||||t-test, 2 sided|||miR454||||0.037
73848918|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|-1.13||||0.041|TWO_SIDED||||||t-test, 2 sided|||miR320e||||0.041
73848919|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|-0.55||||0.043|TWO_SIDED||||||t-test, 2 sided|||miR181a||||0.043
73848920|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|1.95||||0.044|TWO_SIDED||||||t-test, 2 sided|||miR130b||||0.044
73848921|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|-2.18||||0.044|TWO_SIDED||||||t-test, 2 sided|||miR365a||||0.044
73848922|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|2.06||||0.047|TWO_SIDED||||||t-test, 2 sided|||miR135b||||0.047
73848923|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|-2.35||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR1273h||||0.048
73848924|NCT02230189|147243540|SUPERIORITY||Mean Difference (Net)|-1.31||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR3177||||0.048
73848925|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-1.83||||0|TWO_SIDED||||||t-test, 2 sided|||miR6510||||0.0
73848926|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-2.09||||0|TWO_SIDED||||||t-test, 2 sided|||miR3605||||0
73848927|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-5.75||||0|TWO_SIDED||||||t-test, 2 sided|||miR3912||||0
73848928|NCT02230189|147243541|SUPERIORITY||Median Difference (Net)|1.93||||0|TWO_SIDED||||||t-test, 2 sided|||miR15b||||0
73848929|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-2.35||||0|TWO_SIDED||||||t-test, 2 sided|||miR127||||0
73848930|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|1.59||||0|TWO_SIDED||||||t-test, 2 sided|||miR146a||||0
73848931|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|1.21||||0|TWO_SIDED||||||t-test, 2 sided|||miR449b||||0
73848932|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|0.85||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR21-5p||||0.01
73848933|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-1.29||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6842||||0.01
73848934|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|1.24||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR142-5p||||0.01
73848935|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|1.67||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR21||||0.01
73848936|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-4.24||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR493||||0.01
73848937|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-1.46||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR193a||||0.01
73848938|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-0.89||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR149||||0.01
73848939|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|1.06||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR449a||||0.01
73960877|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3973||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \< 65 years The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 7.1 months and high range of 15.6 months.~Conventional Care: low range of 4.4 and high range of 12.4 months."||||0.3973
73960878|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \>= 65 years~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 34.7 months.~Conventional Care: low range of 8.8 and high range of 16.4 months."||||<0.0001
73848940|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-2.1||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6511a||||0.01
73848941|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-1.59||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6843||||0.01
73848942|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-0.95||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR671||||0.01
73848943|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-4.65||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR6503||||0.02
73848944|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|2.84||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR450b||||0.02
73848945|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-4.92||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR485||||0.02
73848946|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-2.49||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR6806||||0.02
73848947|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|2.18||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR3182||||0.02
73848948|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|1.28||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR142-3p||||0.02
73848949|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-1.23||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR320d||||0.02
73848950|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|2.73||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR3928||||0.02
73848951|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|4.59||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR744||||0.02
73848952|NCT02230189|147243541|SUPERIORITY||Median Difference (Net)|3.42||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR206||||0.02
73848953|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|0.9||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR30e||||0.03
73848954|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|1.52||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR4500||||0.03
73848955|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-0.98||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR125a||||0.03
73848956|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-0.6||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR99b||||0.03
73848957|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|2.67||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR1||||0.03
73848958|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-0.77||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR146b||||0.03
73848959|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-3.17||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR1255a||||0.03
73848960|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|1.02||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR223||||0.03
73848961|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-0.78||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR642a||||0.03
73848962|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|2.17||||0.4|TWO_SIDED||||||t-test, 2 sided|||miR548ae||||0.4
73848963|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-0.79||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR146b||||0.04
73848964|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-2.52||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR877||||0.04
73848965|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-0.69||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR181a||||0.04
73848966|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-3.4||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR4467||||0.04
73848967|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-2.48||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR1249||||0.04
73848968|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|3.87||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR766||||0.04
73848969|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|1.07||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR29c||||0.048
73848970|NCT02230189|147243541|SUPERIORITY||Mean Difference (Net)|-1.75||||-1.75|TWO_SIDED||||||t-test, 2 sided|||miR370||||-1.75
73848971|NCT04389866|147243586|SUPERIORITY||Mean Difference (Final Values)|-0.357|STANDARD_DEVIATION|0.864||0.018|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 1 (jawline injections) analysis of Jawline Rating Scale Assessments given by blinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.018
74084724|NCT03653026|147722717|SUPERIORITY||Adjusted Response Rate Difference|30.1|||<|0.001|TWO_SIDED|95.0|24.1|36.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - placebo|||36.2|24.1|<0.001
73848972|NCT04389866|147243586|SUPERIORITY||Mean Difference (Final Values)|-0.214|STANDARD_DEVIATION|0.864||0.082|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 2 (jawline and lateral zygomatic cheek area injections) analysis of Jawline Rating Scale Assessments given by blinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.082
73848973|NCT04389866|147243587|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_DEVIATION|0.497||3.1e-07|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 1 (jawline injections) analysis of Jawline Rating Scale Assessments given by unblinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the unblinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.00000031
73848974|NCT04389866|147243587|SUPERIORITY||Mean Difference (Final Values)|-0.714|STANDARD_DEVIATION|0.497||7.28e-05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline and lateral (zygomatic) cheek area injections arm analysis of Jawline Rating Scale Assessments given by unblinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the unblinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.0000728
73848975|NCT04389866|147243588|SUPERIORITY||Mean Difference (Final Values)|-0.571|STANDARD_DEVIATION|0.611||0.014|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline injections analysis of Jawline Rating Scale Assessments given by subjects.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the subjects' Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.014
73848976|NCT04389866|147243588|SUPERIORITY||Mean Difference (Final Values)|-0.714|STANDARD_DEVIATION|0.726||0.0065|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline and lateral (zygomatic) cheek area injections analysis of Jawline Rating Scale Assessments given by the subjects.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the subjects' Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.0065
73848977|NCT01490918|147243605|SUPERIORITY|||||||0.0036||||||The threshold for statistical significance was p=0.05|ANCOVA|Baselin HbA1c as covariate||primary outcome efficacy will be evaluated between group 1(placebo + metfromin + sitagliptin) and 2 (sitagliptine + metformin + acarbose)||||0.0036
73848978|NCT01490918|147243606|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p=0.05|ANCOVA|Baseline HbA1c as covariate||||||<0.0001
73848979|NCT01490918|147243607|SUPERIORITY|||||||0.0185||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline PPG2hr as covariate||||||0.0185
73848980|NCT01490918|147243608|SUPERIORITY|||||||0.0356||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.0356
73848981|NCT01490918|147243609|SUPERIORITY|||||||0.8258||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.8258
73848982|NCT01490918|147243610|SUPERIORITY|||||||0.9217||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.9217
73848983|NCT01490918|147243611|SUPERIORITY|||||||0.16||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.16
73848984|NCT01490918|147243612|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.004
73848985|NCT01490918|147243613|SUPERIORITY|||||||0.292||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.292
73848986|NCT01490918|147243614|SUPERIORITY|||||||0.314||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.314
73848987|NCT01490918|147243615|SUPERIORITY|||||||0.7563||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.7563
73848988|NCT02967679|147243621|OTHER||Mean Difference (Net)|1.67|STANDARD_DEVIATION|11.45||0.7615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7615
73848989|NCT02967679|147243622|OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|8.89||0.5995|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5995
73848990|NCT02967679|147243623|OTHER||Mean Difference (Net)|4.8|STANDARD_DEVIATION|8.4||0.1641|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1641
73848991|NCT02967679|147243624|OTHER||Mean Difference (Net)|8.5|STANDARD_DEVIATION|16.5||0.0353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0353
73848992|NCT02967679|147243625|OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.4||0.2642|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2642
73848993|NCT02967679|147243626|OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.2||0.1777|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1777
73848994|NCT02967679|147243627|OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|8.2||0.0371|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0371
73848995|NCT02967679|147243628|OTHER||Mean Difference (Net)|-2.2|STANDARD_DEVIATION|2.9||0.0142|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0142
73848996|NCT02967679|147243630|OTHER||Mean Difference (Net)|0.111|STANDARD_DEVIATION|0.201||0.1055|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1055
73900834|NCT05478174|147332301|NON_INFERIORITY|Non inferiority margin is -8%|Risk Difference (RD)|-0.0078|||<|0.001|TWO_SIDED|95.0|-0.0411|0.0255||P-Value for non inferiority test|Farrington-Manning method|||||0.0255|-0.0411|<0.001
73900835|NCT05478174|147332302|SUPERIORITY||Risk Difference (RD)|-0.0716||||0.171|TWO_SIDED|95.0|-0.1742|0.031|||Cochran-Mantel-Haenszel|||||0.0310|-0.1742|0.171
73900836|NCT05478174|147332303|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.231|<|0.001|TWO_SIDED|95.0|-2.22|-1.31|||ANOVA|||||-1.31|-2.22|<0.001
73848997|NCT02967679|147243631|OTHER||Mean Difference (Net)|9.84|STANDARD_DEVIATION|28.16||0.213|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2130
73848998|NCT02967679|147243632|OTHER||Mean Difference (Net)|0.068|STANDARD_DEVIATION|0.112||0.0393|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0393
73848999|NCT02967679|147243633|OTHER||Mean Difference (Net)|-5.905|STANDARD_DEVIATION|6.283||0.0004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0004
73849000|NCT02967679|147243634|OTHER||Mean Difference (Net)|-4.28|STANDARD_DEVIATION|32.21||0.3303|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3303
73849001|NCT02967679|147243635|OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.092||0.9229|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9229
73849002|NCT00600067|147243645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.17||0.0381|TWO_SIDED|95.0|-0.69|-0.02|||ANCOVA|||||-0.02|-0.69|0.0381
73849003|NCT00600067|147243646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|-9.18|-4.21|||ANCOVA|||||-4.21|-9.18|<0.0001
73849004|NCT05501639|147243664|OTHER|||||||0.758|||||||Log Rank|||||||0.758
73849005|NCT05501639|147243665|OTHER|||||||0.474|||||||Log Rank|||||||0.474
73849006|NCT05501639|147243666|OTHER|||||||0.472|||||||Chi-squared|||||||0.472
73849007|NCT05501639|147243667|OTHER||Incidence rate ratio|0.647|||||TWO_SIDED|95.0|0.261|1.604|||||Incidence rate ratio at 6 months|||1.604|0.261|
73849008|NCT05501639|147243667|OTHER||Incidence rate ratio|1.005|||||TWO_SIDED|95.0|0.513|1.969|||||Incidence rate ratio at 12 months|||1.969|0.513|
73849009|NCT05501639|147243668|OTHER|||||||0.222|||||||Chi-squared|||Hospitalisations||||0.222
73849010|NCT05501639|147243668|OTHER|||||||0.553|||||||Chi-squared|||Asthma-related hospitalisations||||0.553
73849011|NCT05501639|147243668|OTHER|||||||0.192|||||||Chi-squared|||ED visits||||0.192
73849012|NCT05501639|147243668|OTHER|||||||0.383|||||||Chi-squared|||Asthma-related ED visits||||0.383
73849013|NCT05501639|147243668|OTHER|||||||0.338|||||||Chi-squared|||OP visits||||0.338
73849014|NCT05501639|147243668|OTHER||||||<|0.0001|||||||Chi-squared|||Asthma-related OP visits||||<0.0001
73849015|NCT05501639|147243669|OTHER|||||||0.538|||||||t-test, 2 sided|||Hospitalisations||||0.538
73849016|NCT05501639|147243669|OTHER|||||||0.913|||||||t-test, 2 sided|||Asthma-related hospitalisations||||0.913
73849017|NCT05501639|147243669|OTHER|||||||0.688|||||||t-test, 2 sided|||ED visits||||0.688
73849018|NCT05501639|147243669|OTHER|||||||0.892|||||||t-test, 2 sided|||Asthma-related ED visits||||0.892
73849019|NCT05501639|147243669|OTHER||||||<|0.0001|||||||t-test, 2 sided|||OP visits||||<0.0001
73849020|NCT05501639|147243669|OTHER|||||||0.002|||||||t-test, 2 sided|||Asthma-related OP visits||||0.002
73849021|NCT05501639|147243670|OTHER|||||||0.378|||||||Chi-squared|||||||0.378
73849022|NCT00251693|147243671|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.33||||0.004||95.0|2.17|10.48||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||10.48|2.17|0.004
73849023|NCT00251693|147243671|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.84||||0.001||95.0|2.7|10.98||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||10.98|2.70|0.001
73849024|NCT00251693|147243671|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.727
74023709|NCT01381094|147600237|SUPERIORITY||||||=|0.0083|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0083
73849025|NCT00251693|147243672|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.002
73960879|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0707||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \>= 75 years. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 1.7 months and high range of 15.0 months.~Conventional Care: low range of 4.1 and high range of 7.6 months."||||0.0707
73960880|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0042||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Male~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 10.8 and high range of 17.2 months."||||0.0042
73960881|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0469||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Female~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 13.0 months and high range of 'does not exist'.~Conventional Care: low range of 8.2 and high range of 17.6 months."||||0.0469
73960882|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 21.1 months and high range of 'does not exist'.~Conventional Care: low range of 9.3 and high range of 21.9 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||FAB: Refractory anemia with excess blasts (RAEB). All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.0056
73960883|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0322||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"FAB: RAEB in transformation~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 11.7 months and high range of 'does not exist'.~Conventional Care: low range of 9.4 and high range of 17.0 months."||||0.0322
74023710|NCT01381094|147600237|SUPERIORITY||||||=|0.0323|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0323
74023711|NCT01381094|147600237|SUPERIORITY||||||=|0.0003|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0003
74023712|NCT01381094|147600237|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0001
73849026|NCT00251693|147243672|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.045
73849027|NCT00251693|147243672|SUPERIORITY_OR_OTHER|||||||0.245||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.245
73849028|NCT00251693|147243673|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.011
73849029|NCT00251693|147243673|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.017
73849030|NCT00251693|147243673|SUPERIORITY_OR_OTHER|||||||0.927||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.927
74023713|NCT01381094|147600237|SUPERIORITY||||||=|0.423|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.4230
74023714|NCT01381094|147600237|SUPERIORITY||||||=|0.0023|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0023
73849031|NCT00251693|147243674|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.2||||0.06||95.0|2.3|10.11||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||10.11|2.30|0.060
73849032|NCT00251693|147243674|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.08||||0.029||95.0|2.16|10.0||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||10.00|2.16|0.029
73849033|NCT00251693|147243674|SUPERIORITY_OR_OTHER|||||||0.707||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.707
73849034|NCT00251693|147243675|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.705
73849035|NCT00251693|147243675|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.146
73849036|NCT00251693|147243675|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.283
73849037|NCT00251693|147243676|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.896
73849038|NCT00251693|147243676|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.241
73849039|NCT00251693|147243676|SUPERIORITY_OR_OTHER|||||||0.211||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.211
73849040|NCT02358993|147243698|NON_INFERIORITY|Non-inferiority of the primary outcome was achieved if the lower limit of the 95% confidence interval of the mean difference was greater than the specified non-inferiority margin of 15%(a clinically relevant margin within the range of those commonly used in non-inferiority and equivalence trials for studies examining antibiotic use for UTI)|Risk Ratio (RR)|-0.01|||||TWO_SIDED|95.0||||||||||||
73849041|NCT03192137|147243707|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was two-sided and performed using a significance (alpha) level of 0.05.||||||0.0005||||||P-values were from a Chi-Square test (with continuity correction) of differences between treatments in the proportion of participants with anterior chamber cells Grade 0 who did not receive rescue medication versus all other grades combined.|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||||||0.0005
73849042|NCT03192137|147243708|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.217|||<|0.0001|TWO_SIDED|95.0|1.823|5.675||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 1||5.675|1.823|<0.0001
73849043|NCT03192137|147243708|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|4.337|||<|0.0001|TWO_SIDED|95.0|2.305|8.161||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 8||8.161|2.305|<0.0001
73849044|NCT03192137|147243708|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.113|8.033||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 15||8.033|2.113|<0.0001
73849045|NCT03192137|147243708|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.58||||0.0043|TWO_SIDED|95.0|1.38|4.822||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 18||4.822|1.380|0.0043
73849046|NCT03192137|147243708|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.277||||0.0005|TWO_SIDED|95.0|1.695|6.335||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 29||6.335|1.695|0.0005
74023715|NCT01381094|147600237|SUPERIORITY||||||=|0.0009|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0009
74023716|NCT01381094|147600237|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
73930699|NCT03238911|147391293|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.49|-1.11|<0.0001
73930700|NCT03238911|147391293|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.0006|TWO_SIDED|95.0|-1.01|-0.28|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.28|-1.01|0.0006
74023717|NCT01381094|147600237|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
73930701|NCT03238911|147391293|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.0014|TWO_SIDED|95.0|-0.94|-0.23|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.23|-0.94|0.0014
73930702|NCT03238911|147391294|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.7447|TWO_SIDED|95.0|-7.96|5.71|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||5.71|-7.96|0.7447
73930703|NCT03238911|147391294|SUPERIORITY||Mean Difference (Final Values)|-9.7||||0.0363|TWO_SIDED|95.0|-18.78|-0.63|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.63|-18.78|0.0363
73930704|NCT03238911|147391294|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.9242|TWO_SIDED|95.0|-10.56|9.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||9.59|-10.56|0.9242
73930705|NCT03238911|147391294|SUPERIORITY||Mean Difference (Final Values)|-11.17||||0.0602|TWO_SIDED|95.0|-22.84|0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.49|-22.84|0.0602
73930706|NCT03238911|147391294|SUPERIORITY||Mean Difference (Final Values)|-18.2||||0.0008|TWO_SIDED|95.0|-28.68|-7.73|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-7.73|-28.68|0.0008
73930707|NCT03238911|147391294|SUPERIORITY||Mean Difference (Final Values)|-19.79||||0.0031|TWO_SIDED|95.0|-32.75|-6.83|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-6.83|-32.75|0.0031
73930708|NCT03238911|147391295|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.267|TWO_SIDED|95.0|-0.029|0.104|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.104|-0.029|0.2670
73930709|NCT03238911|147391295|SUPERIORITY||Mean Difference (Final Values)|0.085||||0.004|TWO_SIDED|95.0|0.028|0.142|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.142|0.028|0.0040
73960884|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB 1. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 6.6 months and high range of 'does not exist'.~Conventional Care: low range of 1.8 and high range of 9.8 months."||||0.1679
73960885|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB-2~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.9 months and high range of 'does not exist'.~Conventional Care: low range of 8.8 and high range of 19.4 months."||||0.0692
73960886|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: Other~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.6 months and high range of 'does not exist'.~Conventional Care: low range of 11.1 and high range of 17.5 months."||||0.0017
73960887|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 'does not exist'.~Conventional Care: low range of 8.7 and high range of 24.1 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||IPSS: Intermediate 2 All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.1030
73960888|NCT00071799|147457653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 15.0 months and high range of 'does not exist'.~Conventional Care: low range of 9.0 and high range of 17.0 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification||IPSS: High All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.0020
73960889|NCT00071799|147457654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.|Log Rank|||||||0.0025
73960890|NCT00071799|147457654|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68||||0.0027|TWO_SIDED|95.0|0.53|0.87|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.87|0.53|0.0027
73960891|NCT00071799|147457655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2555||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||||||0.2555
73960892|NCT00071799|147457655|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.2562|TWO_SIDED|95.0|0.6|1.15|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||1.15|0.60|0.2562
73960893|NCT00071799|147457656|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period.||||<0.0001
73960894|NCT00071799|147457657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.||||0.0005
73849047|NCT02737501|147243733|SUPERIORITY||Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.35|0.66||P-values are from a log-rank test stratified by randomization stratification factors (current; presence of intracranial central nervous system (iCNS) metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).|Log Rank||The hazard ratio was obtained using a Cox proportional hazards model with randomization stratification factors (current) as covariates.|||0.66|0.35|<0.0001
73849048|NCT02737501|147243734|SUPERIORITY||Odds Ratio (OR)|1.74||||0.033|TWO_SIDED|95.0|1.04|2.91|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of intracranial central nervous system (iCNS) metastases at Baseline, and prior chemotherapy for locally advanced or metastatic disease (current strata).|||2.91|1.04|0.0330
73849049|NCT02737501|147243735|SUPERIORITY||Odds Ratio (OR)|13.56|||<|0.0001|TWO_SIDED|95.0|4.7|39.11|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of prior chemotherapy for Locally advanced or metastatic disease at study entry (current strata).|||39.11|4.70|<0.0001
73849050|NCT02737501|147243736|SUPERIORITY||Hazard Ratio (HR)|0.293|||<|0.0001|TWO_SIDED|95.0|0.17|0.51||P-values are from a log-rank test stratified by randomization stratification factors (current; presence of iCNS metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).|Log Rank||The hazard ratio was obtained using a Cox proportional hazards model with prior chemotherapy for locally advanced or metastatic disease (current strata) as covariate.|||0.51|0.17|<0.0001
73849051|NCT02737501|147243740|SUPERIORITY||Odds Ratio (OR)|0.93||||0.822|TWO_SIDED|95.0|0.47|1.82|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of iCNS metastases at Baseline, and prior chemotherapy for locally advanced or metastatic disease (current strata).|||1.82|0.47|0.8220
73849052|NCT02737501|147243742|SUPERIORITY||Least Square Mean Difference|5.79||||0.0295|TWO_SIDED|95.0|0.58|11.0||p-values were obtained using mixed effects models stratified by presence of iCNS metastases at study entry, prior chemotherapy at Baseline.|Mixed Models Analysis|A mixed effect model is used with an unstructured covariance matrix.||||11.00|0.58|0.0295
73849053|NCT00405288|147243750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|STANDARD_DEVIATION|450.0||0.17|TWO_SIDED|95.0|0.0|200.0|||t-test, 2 sided|||"Null hypothesis: Birth weight in pregnancies exposed to Proctofoam-HC will be the same as control pregnancies.~To detect a clinically significant decrease of 200 g in birth weight at a power of 80% and alpha of 5%, 200 women per group were required. Post hoc power analysis of our cohort revealed that, in fact, we had a 91.5% power to detect a 200 g difference in birth weight between the two groups."||200|0|0.17
73849054|NCT00405288|147243751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|3.0||0.16|TWO_SIDED|95.0|0.0|3.0|||Wilcoxon (Mann-Whitney)|||||3|0|0.16
73849055|NCT00405288|147243752|SUPERIORITY_OR_OTHER||chi square|30.0||||0.003||95.0|||||McNemar|||The null hypothesis is that the proportion of vaginal deliveries in the Proctofoam and Control groups will be the same (ie. there will not be a greater proportion of complicated deliveries in either group).||||0.003
73849056|NCT00405288|147243753|SUPERIORITY_OR_OTHER||chi square|5.0||||0.55||95.0|||||McNemar|||The null hypothesis is that the proportion of pre-term births in the Proctofoam and Control groups will be the same.||||0.55
73849057|NCT00405288|147243754|SUPERIORITY_OR_OTHER||chi square|10.0||||0.97||95.0|||||McNemar|||Fetal Distress The null hypothesis is that the proportion of fetal distress in the Proctofoam and Control groups will be the same.||||0.97
73849058|NCT00405288|147243755|SUPERIORITY_OR_OTHER||binary|3.0||||0.31||95.0|||||McNemar|||Low birth weight \<2,500g; The null hypothesis is that the proportion of low birth weight babies in the Proctofoam and Control groups will be the same.||||0.31
73849059|NCT00405288|147243756|SUPERIORITY_OR_OTHER||chi square|10.0||||0.87||95.0|||||McNemar|||The null hypothesis is that the proportion of healthy babies (not requiring NICU (neonatal intensive care unit) or additional medical monitoring) will be the same between the Proctofoam and Control groups.||||0.87
73849060|NCT00405288|147243757|SUPERIORITY_OR_OTHER||proportion|4.0||||0.99||95.0|||||Fisher Exact|||||||0.99
73960895|NCT00071799|147457658|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period||||1.000
73849061|NCT00405288|147243758|SUPERIORITY_OR_OTHER||proportion|3.0||||0.99||95.0|||||Fisher Exact|||||||0.99
73849062|NCT00405288|147243759|SUPERIORITY_OR_OTHER||proportion|2.0||||0.99||95.0|||||Fisher Exact|||||||0.99
73849063|NCT00405288|147243760|SUPERIORITY_OR_OTHER||proportions|2.0||||0.35||95.0|||||Fisher Exact|||||||0.35
73849064|NCT04067492|147243793|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|28.63||||0.1331|TWO_SIDED|95.0|4.21|53.05||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||53.05|4.21|0.1331
73960896|NCT00071799|147457659|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.||||<0.0001
73960897|NCT00071799|147457660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Fisher Exact|||Overall (Complete + Partial Remission)||||0.0001
73960898|NCT00071799|147457660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0|||||Fisher Exact|||Complete remission||||0.0150
74023718|NCT01381094|147600237|SUPERIORITY||||||=|0.5291|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5291
73849065|NCT04067492|147243793|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|-2.05||||0.1331|TWO_SIDED|95.0|-30.6|26.5||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||26.50|-30.60|0.1331
73849066|NCT04067492|147243793|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|16.7||||0.1331|TWO_SIDED|95.0|-12.67|46.08||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||46.08|-12.67|0.1331
73849067|NCT04067492|147243793|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|3.12||||0.1331|TWO_SIDED|95.0|-25.1|31.33||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\]|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||31.33|-25.10|0.1331
73960899|NCT00071799|147457660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0094||95.0|||||Fisher Exact|||Partial Remission||||0.0094
73960900|NCT00071799|147457660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3297||95.0|||||Fisher Exact|||Stable Disease||||0.3297
73960901|NCT00071799|147457661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||Any Improvement||||<0.0001
73960902|NCT00071799|147457661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||Erythroid Response - Major||||<0.0001
73960903|NCT00071799|147457661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6203||95.0|||||Fisher Exact|||Erythroid Response - Minor||||0.6203
73960904|NCT00071799|147457661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Fisher Exact|||Platelet Response - Major||||0.0003
73960905|NCT00071799|147457661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7514||95.0|||||Fisher Exact|||Platelet Response - Minor||||0.7514
73960906|NCT00071799|147457661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8695||95.0|||||Fisher Exact|||Neutrophil Response - Major||||0.8695
73960907|NCT00071799|147457661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0|||||Fisher Exact|||Neutrophil Response - Minor||||0.1760
74023719|NCT01381094|147600237|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
73960908|NCT00071799|147457662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank|||||||0.0466
73960909|NCT00071799|147457662|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0474|TWO_SIDED|95.0|0.53|1.0|||Regression, Cox|||||1.00|0.53|0.0474
73960910|NCT00071799|147457663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank|||||||0.0002
73960911|NCT00071799|147457664|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.67||||0.1327|TWO_SIDED|95.0|0.35|1.2|||exact binomial|||||1.20|0.35|0.1327
73960912|NCT00071799|147457666|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||||||<0.0001
73849068|NCT04067492|147243793|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|5.96||||0.1331|TWO_SIDED|95.0|-24.22|36.14||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||36.14|-24.22|0.1331
73849069|NCT04067492|147243800|OTHER|||||||0.5995|||||||Log Rank|||||||0.5995
73849070|NCT04067492|147243800|OTHER|||||||0.9012|||||||Log Rank|||||||0.9012
73849071|NCT04067492|147243802|OTHER||difference in proportions|63.5||||0.0066|TWO_SIDED|95.0|19.9|88.6|||Fisher Exact|||||88.6|19.9|0.0066
73849072|NCT04067492|147243802|OTHER||difference in proportions|-5.6|||>|0.9999|TWO_SIDED|95.0|-50.1|45.5|||Fisher Exact|||||45.5|-50.1|>0.9999
73849073|NCT04067492|147243802|OTHER||difference in proportions|27.8||||0.3287|TWO_SIDED|95.0|-26.8|71.8|||Fisher Exact|||||71.8|-26.8|0.3287
73849074|NCT04067492|147243802|OTHER||difference in proportions|27.8||||0.3287|TWO_SIDED|95.0|-26.8|71.8|||Fisher Exact|||||71.8|-26.8|0.3287
73849075|NCT04067492|147243802|OTHER||difference in proportions|17.8||||0.5804|TWO_SIDED|95.0|-33.7|67.8|||Fisher Exact|||||67.8|-33.7|0.5804
73849076|NCT00833027|147243824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.85|<|0.001|ONE_SIDED|95.0|||||Student's T-test|Student's T-test for paired samples||||||<0.001
73849077|NCT01646814|147243840|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||0.019
73849078|NCT01333436|147243841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.8|STANDARD_DEVIATION|36.8||0.0078||95.0|||||t-test, 2 sided|||||||0.0078
73849079|NCT01333436|147243842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.5|STANDARD_DEVIATION|13.9||0.0675||95.0|||||t-test, 2 sided|||||||0.0675
73849080|NCT01333436|147243843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|4.8||0.1798||95.0|||||t-test, 2 sided|||||||0.1798
73849081|NCT00444106|147243844|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sided exact test for a single propn.|One-sided exact test for a single proportion.||"One-sided null hypothesis that the incidence rate of ABR Wave III latency changes is greater than or equal to 15%.~Increase in ABR Wave III latency between baseline and Day 7 of greater than 0.3 ms."||||<.0001
73849082|NCT04570384|147243848|OTHER||Hazard Ratio (HR)|1.14||||0.782|TWO_SIDED|95.0|0.45|2.86|||Log Rank|||||2.86|0.45|0.782
73960913|NCT00071799|147457666|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.35|0.7|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.70|0.35|<0.0001
73849083|NCT04570384|147243848|OTHER||Odds Ratio (OR)|1.25||||0.668|TWO_SIDED|95.0|0.46|3.4|||Regression, Logistic|||||3.40|0.46|0.668
73849084|NCT04570384|147243849|OTHER||Hazard Ratio (HR)|1.58||||0.36|TWO_SIDED|95.0|0.59|4.22|||Log Rank|||||4.22|0.59|0.360
73849085|NCT04570384|147243850|OTHER||Hazard Ratio (HR)|0.49||||0.285|TWO_SIDED|95.0|0.13|1.83|||Log Rank|||||1.83|0.13|0.285
73849086|NCT04570384|147243850|OTHER||Odds Ratio (OR)|0.6||||0.471|TWO_SIDED|95.0|0.15|2.41|||Regression, Logistic|||||2.41|0.15|0.471
73849087|NCT04570384|147243856|OTHER||Odds Ratio, log|0.81||||0.668|TWO_SIDED|95.0|0.3|2.2|||Zero-inflated negative binomial analyses|||||2.20|0.30|0.668
73849088|NCT04570384|147243856|OTHER||Incidence Rate Ratio|0.66||||0.437|TWO_SIDED|95.0|0.23|1.9|||Zero-inflated negative binomial analyses|||||1.90|0.23|0.437
73960914|NCT03959241|147457668|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.001|TWO_SIDED|95.0|0.492|0.835||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of GRFS hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies.||0.835|0.492|0.001
73849089|NCT04570384|147243857|OTHER||Odds Ratio (OR)|0.35||||0.232|TWO_SIDED|95.0|0.06|1.97|||Regression, Logistic|||||1.97|0.06|0.232
73849090|NCT04570384|147243858|OTHER||Odds Ratio (OR)|0.84||||0.729|TWO_SIDED|95.0|0.31|2.28|||Regression, Logistic|||||2.28|0.31|0.729
73849091|NCT04570384|147243859|OTHER||Odds Ratio, log|1.22||||0.706|TWO_SIDED|95.0|0.43|3.44|||Zero-inflated negative binomial analyses|||||3.44|0.43|0.706
73849092|NCT04570384|147243859|OTHER||Incidence Rate Ratio|1.12||||0.788|TWO_SIDED|95.0|0.49|2.56|||Zero-inflated negative binomial analyses|||||2.56|0.49|0.788
73849093|NCT04570384|147243860|OTHER||Incidence Rate Ratio|1.08||||0.834|TWO_SIDED|95.0|0.52|2.25|||Negative binomial analysis|||||2.25|0.52|0.834
73849094|NCT01900665|147243863|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.095|TWO_SIDED|95.0|-1.73|0.14|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.||||0.14|-1.73|0.095
73849095|NCT00953706|147243897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.2||0.1509|TWO_SIDED|95.0|-0.6|4.1|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit as fixed effects, and participant as a random effect, with adjustment for age and continuous baseline value of percent predicted FEV1.||4.1|-0.6|0.1509
73849096|NCT00953706|147243898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.1||0.5408|TWO_SIDED|95.0|-2.9|5.6|||Mixed Models Analysis|||Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with the dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for for age and baseline value for CFQ-R score, using unstructured covariance matrix||5.6|-2.9|0.5408
73960915|NCT03959241|147457669|SUPERIORITY|||||||0.995||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups.||||0.995
73960916|NCT03959241|147457669|SUPERIORITY|||||||0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of grade III-IV acute GVHD post-transplantation between the treatment groups||||0.001
73960917|NCT03959241|147457669|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.879|TWO_SIDED|95.0|0.758|1.267||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups using a Cox regression model for the cause-specific hazard of aGVHD||1.267|0.758|0.879
73960918|NCT03959241|147457669|SUPERIORITY||Hazard Ratio (HR)|0.386||||0.001|TWO_SIDED|95.0|0.215|0.691||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of grade III-IV aGVHD hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies.||0.691|0.215|0.001
73960919|NCT03959241|147457673|SUPERIORITY|||||||0.005||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of chronic GVHD post-transplantation between the treatment groups||||0.005
73960920|NCT03959241|147457673|SUPERIORITY||Hazard Ratio (HR)|0.556||||0.002|TWO_SIDED|95.0|0.381|0.813||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of the chronic GVHD hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||0.813|0.381|0.002
73960921|NCT03959241|147457676|SUPERIORITY|||||||0.038||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The null hypothesis is that there is no difference of Immunosuppression-Free Survival between the treatment groups||||0.038
73960922|NCT03959241|147457677|SUPERIORITY|||||||0.032||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Neutrophil Recovery between the treatment groups||||0.032
73960923|NCT03959241|147457678|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet Recovery greater than or equal to 20,000/mm\^3 between the treatment groups||||<0.001
73960924|NCT03959241|147457678|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet Recovery greater than or equal to 50,000/mm\^3 between the treatment groups||||<0.001
73960925|NCT03959241|147457679|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Lymphocyte Recovery between the treatment groups||||<0.001
73849097|NCT00953706|147243899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.4||0.0384|TWO_SIDED|95.0|-5.6|-0.2|||Mixed Models Analysis|||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous age and baseline value for age, sweat chloride, using unstructured covariance matrix.||-0.2|-5.6|0.0384
73960926|NCT03959241|147457680|SUPERIORITY|||||||0.919||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference of Donor Cell Engraftment at Day 28 after transplantation between the treatment groups||||0.919
73960927|NCT03959241|147457680|SUPERIORITY|||||||0.198||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Fisher Exact|||The null hypothesis is that there is no difference of Donor Cell Engraftment at Day 100 after transplantation between the treatment groups||||0.198
73849098|NCT00953706|147243900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.7265|TWO_SIDED|95.0|-1.1|0.7|||Mixed Models Analysis|||The analysis used the linear mixed model with treatment as fixed effects, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group (\< 18 years and ≥ 18 years) and percent predicted forced expiratory volume (FEV1) severity (\< 70%, ≥ 70% to ≤ 90%, \> 90%) at screening, with random intercept and random slope. Rate of change in the study period is the slope of weight versus time (days) multiplied by the number of days in the study period (112 days).||0.7|-1.1|0.7265
73849099|NCT00052910|147243921|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.99|||||TWO_SIDED|95.0|0.79|1.24|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV|||1.24|0.79|
73849100|NCT00052910|147243922|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.03|||||TWO_SIDED|95.0|0.83|1.28|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV|||1.28|0.83|
73849101|NCT01187095|147243923|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimation parameter|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73849102|NCT01187095|147243923|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
73849103|NCT01475721|147243933|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority comparison is statistically significant if the upper bound of the two-sided 95% CI falls below 2, the non-inferiority margin, and the non-inferiority test one-sided p-value \<0.025.|Hazard Ratio (HR)|1.029||||0.003|TWO_SIDED|95.0|0.638|1.662|||Regression, Cox|||||1.662|0.638|0.003
73849104|NCT01475721|147243934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.834||||0.203|TWO_SIDED|95.0|0.63|1.103|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy.|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.103|0.630|0.203
73960928|NCT03959241|147457681|SUPERIORITY|||||||0.67||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference of quantitative donor chimerism at Day 28 after transplantation between the treatment groups||||0.670
73960929|NCT03959241|147457681|SUPERIORITY|||||||0.607||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference of quantitative donor chimerism at Day 100 after transplantation between the treatment groups||||0.607
73960930|NCT03959241|147457682|SUPERIORITY|||||||0.906||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Disease Relapse between the treatment groups||||0.906
73960931|NCT03959241|147457682|SUPERIORITY||Hazard Ratio (HR)|0.985||||0.947|TWO_SIDED|95.0|0.641|1.515||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Disease Relapse hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.515|0.641|0.947
73960932|NCT03959241|147457683|SUPERIORITY|||||||0.167||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Treatment-related Mortality between the treatment groups||||0.167
73960933|NCT03959241|147457683|SUPERIORITY||Hazard Ratio (HR)|0.675||||0.133|TWO_SIDED|95.0|0.404|1.127||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Treatment-related Mortality hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.127|0.404|0.133
73960934|NCT03959241|147457687|SUPERIORITY|||||||0.018||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grade 2 and 3 infections between the treatment groups||||0.018
73960935|NCT03959241|147457688|SUPERIORITY|||||||0.825||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of CMV between the treatment groups||||0. 825
73960936|NCT03959241|147457689|SUPERIORITY|||||||0.351||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Disease-Free Survival between the treatment groups||||0.351
73960937|NCT03959241|147457689|SUPERIORITY||Hazard Ratio (HR)|0.847||||0.32|TWO_SIDED|95.0|0.61|1.176||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Disease-Free Survival hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.176|0.610|0.320
73960938|NCT03959241|147457690|SUPERIORITY|||||||0.335||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Overall Survival between the treatment groups||||0.335
73960939|NCT03959241|147457690|SUPERIORITY||Hazard Ratio (HR)|0.797||||0.252|TWO_SIDED|95.0|0.541|1.175||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of the Overall Survival hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.175|0.541|0.252
73960940|NCT00346151|147457719|SUPERIORITY_OR_OTHER||Incidence Rate|60.0||||||95.0|15.0|95.0|||95% exact binomial CI of proportion|||Proportion of participant's cumulative incidence of acute rejection at 24 weeks with 95% exact binomial confidence interval. Local biopsy reads were used in determining primary endpoint.||95|15|
73960941|NCT00346151|147457720|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|40.0|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|40|
73960942|NCT00346151|147457721|SUPERIORITY_OR_OTHER||Incidence rate|80.0||||||95.0|28.0|99.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||99|28|
73960943|NCT00346151|147457724|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|40.0|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|40|
73960944|NCT00346151|147457726|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
73960945|NCT00346151|147457727|SUPERIORITY_OR_OTHER||Incidence Rate|80.0||||||95.0|28.0|99.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||99|28|
73960946|NCT00346151|147457728|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
73960947|NCT00346151|147457729|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
73960948|NCT00346151|147457730|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|47.8|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|47.8|
73960949|NCT00346151|147457731|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
73960950|NCT00346151|147457732|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
73960951|NCT00346151|147457733|SUPERIORITY_OR_OTHER||Incidence Rate|20.0||||||95.0|0.5|71.6|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||71.6|0.5|
73960952|NCT01574807|147457754|SUPERIORITY||Percentage difference|0.0||||1|TWO_SIDED|||||Multiple McNemar tests corrected with Step-down Bonferroni method of Holm. A priori threshold for significance was 0.05.|McNemar|||||||1.00
73849105|NCT01475721|147243934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.839||||0.188|TWO_SIDED|95.0|0.645|1.09|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.090|0.645|0.188
73849106|NCT01475721|147243934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.002|TWO_SIDED|95.0|0.645|0.905|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||0.905|0.645|0.002
73849107|NCT01475721|147243934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.071|TWO_SIDED|95.0|0.451|1.034|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.034|0.451|0.071
73849108|NCT01475721|147243934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.373|TWO_SIDED|95.0|0.659|1.17|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.170|0.659|0.373
73849109|NCT01475721|147243934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.271|TWO_SIDED|95.0|0.665|1.122|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.122|0.665|0.271
73849110|NCT01475721|147243934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.001|TWO_SIDED|95.0|0.637|0.895|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||0.895|0.637|0.001
73849111|NCT01475721|147243934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.075|TWO_SIDED|95.0|0.454|1.04|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.040|0.454|0.075
73849112|NCT01475721|147243936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.776||||0.123|TWO_SIDED|95.0|0.562|1.071|||Regression, Cox|||||1.071|0.562|0.123
73960953|NCT01152190|147457849|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.009||0.121||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.121
73849113|NCT01475721|147243937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|||<|0.001|TWO_SIDED|95.0|-0.385|-0.141|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy|||-0.141|-0.385|<0.001
73849114|NCT01475721|147243937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222||||0.003|TWO_SIDED|95.0|-0.369|-0.076|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|||-0.076|-0.369|0.003
73849115|NCT01475721|147243937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|||<|0.001|TWO_SIDED|95.0|-0.238|-0.106|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|||-0.106|-0.238|<0.001
73960954|NCT01152190|147457850|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.226||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.226
74023720|NCT01381094|147600237|SUPERIORITY||||||=|0.0222|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0222
73960955|NCT01152190|147457851|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.009||0.208||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.208
73960956|NCT01152190|147457851|SUPERIORITY_OR_OTHER||Difference in LS Means|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.066||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.066
73960957|NCT01152190|147457851|SUPERIORITY_OR_OTHER||Difference in LS Means|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.195||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.195
74023721|NCT01381094|147600237|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
73960958|NCT01152190|147457851|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.022||0.625||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.625
73960959|NCT01152190|147457852|SUPERIORITY_OR_OTHER||Difference in LS Means|2.63|STANDARD_ERROR_OF_MEAN|3.38||0.439||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.439
74023722|NCT01381094|147600237|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
74023723|NCT01381094|147600237|SUPERIORITY||||||=|0.9314|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9314
73960960|NCT01152190|147457852|SUPERIORITY_OR_OTHER||Difference in LS Means|0.51|STANDARD_ERROR_OF_MEAN|2.867||0.86||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.860
74023724|NCT01381094|147600238|SUPERIORITY||||||=|0.5219|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.5219
73960961|NCT01152190|147457852|SUPERIORITY_OR_OTHER||Difference in LS Means|3.47|STANDARD_ERROR_OF_MEAN|2.937||0.24||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.240
73849116|NCT01475721|147243937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.251|TWO_SIDED|95.0|-0.216|0.056|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS therapy|||0.056|-0.216|0.251
73849117|NCT04343092|147243939|SUPERIORITY||Mean Difference (Final Values)|7.92||||0.05|TWO_SIDED||||||t-test, 2 sided||||Historical control population included: Hydroxychloroquin (HCQ) 400mg BID at admission day then 200mg BID for 5 days plus Azithromycin (AZT) 500mg at admission day then 250mg for 5 days.|||0.05
73849118|NCT00803738|147243940|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the primary clinical equivalence analysis, a 90% confidence interval was constructed on the difference in the therapeutic cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-4.3|15.02|||Wald's method with Yates' continuity|||||15.02|-4.30|
73849119|NCT00803738|147243941|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 90% confidence interval was constructed on the difference in the mycological cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-4.66|11.49|||Wald's method with Yates' continuity|||||11.49|-4.66|
73849120|NCT00803738|147243942|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 90% confidence interval was constructed on the difference in the clinical cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-1.35|16.88|||Wald's method with Yates' continuity|||||16.88|-1.35|
73849121|NCT00387088|147243955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|0.085|0.118|||ANCOVA|ANCOVA with pooled centre, LABA use, and treatment fitted as main effects and the baseline trough FEV1 as a covariate.||||0.118|0.085|<0.0001
73849122|NCT02848092|147243988|SUPERIORITY||Incidence Risk Ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.76|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 1 month) using a generalized estimating equation.||||.76|.52|<.0001
73849123|NCT02848092|147243989|SUPERIORITY||Mean Difference (Final Values)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.29|-0.13|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 1 month) using a generalized estimating equation.||||-.13|-.29|<.0001
73849124|NCT02848092|147243990|SUPERIORITY||Incidence Risk Ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.76|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 6 month) using a generalized estimating equation.||||.76|.52|<.0001
73849125|NCT02848092|147243991|SUPERIORITY||Mean Difference (Final Values)|-0.22|||<|0.0001|TWO_SIDED|95.0|-0.31|-0.13|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 6 month) using a generalized estimating equation.||||-.13|-.31|<.0001
73849126|NCT02848092|147243992|SUPERIORITY||Risk Ratio (RR)|0.6|||||TWO_SIDED|95.0|0.41|0.89||||||||.89|.41|
73849127|NCT02848092|147243993|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.61|0.92||||||||.92|.61|
73849128|NCT01639469|147243994|SUPERIORITY||Incidence Rate Ratio|0.39|||<|0.001|TWO_SIDED|95.0|0.22|0.68|||Negative Binomial Regression|||Testing to see if there is a significant difference in fall rates over 12months between the two groups.||0.68|0.22|<0.001
73849129|NCT02383862|147244006|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.79||0.165|TWO_SIDED|95.0|-0.45|2.64|||t-test, 2 sided|||||2.64|-0.45|0.165
73849130|NCT02383862|147244007|SUPERIORITY||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|1.05||0.425|TWO_SIDED|95.0|-1.23|2.91|||t-test, 2 sided|||||2.91|-1.23|0.425
73849131|NCT02383862|147244008|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|1.05||0.539|TWO_SIDED|95.0|-1.41|2.7|||t-test, 2 sided|||||2.70|-1.41|0.539
73849132|NCT02383862|147244009|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|1.16||0.471|TWO_SIDED|95.0|-1.44|3.11|||t-test, 2 sided|||||3.11|-1.44|0.471
73849133|NCT02383862|147244010|SUPERIORITY||Mean Difference (Final Values)|1.49|STANDARD_ERROR_OF_MEAN|1.1||0.174|TWO_SIDED|95.0|-0.66|3.65|||t-test, 2 sided|||||3.65|-0.66|0.174
73960962|NCT01152190|147457852|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|2.729||0.839||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.839
73849134|NCT02383862|147244011|SUPERIORITY||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|1.36||0.222|TWO_SIDED|95.0|-1.0|4.35|||t-test, 2 sided|||||4.35|-1.00|0.222
73849135|NCT03856359|147244060|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
73849136|NCT03856359|147244062|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
73849137|NCT03856359|147244064|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
73849138|NCT03856359|147244066|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
73849139|NCT03856359|147244067|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
73849140|NCT03856359|147244068|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
73849141|NCT03856359|147244069|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
73849142|NCT03856359|147244070|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
74023725|NCT01381094|147600238|SUPERIORITY||||||=|0.6743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.6743
74023726|NCT01381094|147600238|SUPERIORITY||||||=|0.0078|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0078
74023727|NCT01381094|147600238|SUPERIORITY||||||=|0.0301|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0301
73900867|NCT04251156|147332410|SUPERIORITY|Responses were analysed using an analysis of covariance model with randomized treatment and type 2 diabetes status as factors and baseline body weight as covariate.|Treatment difference|-8.47|||<|0.0001|TWO_SIDED|95.0|-10.17|-6.76|||ANCOVA|||Treatment policy estimand||-6.76|-10.17|<0.0001
73900868|NCT04251156|147332411|SUPERIORITY|Responses were analysed using a binary logistic regression model with randomized treatment and type 2 diabetes status as factors and baseline body weight as covariate.|Odds Ratio (OR)|13.07|||<|0.0001|TWO_SIDED|95.0|7.4|23.1|||Regression, Logistic|||Treatment policy estimand||23.10|7.40|<0.0001
74023728|NCT01381094|147600238|SUPERIORITY||||||=|0.4502|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.4502
74023729|NCT01381094|147600238|SUPERIORITY||||||=|0.6967|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6967
73849143|NCT03856359|147244071|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
73849144|NCT03856359|147244072|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.65
73849145|NCT03856359|147244073|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
73849146|NCT03856359|147244074|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
73849147|NCT03856359|147244075|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
73849148|NCT03856359|147244076|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
73849149|NCT03856359|147244077|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
73960963|NCT01152190|147457852|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.2|STANDARD_ERROR_OF_MEAN|5.77||0.468||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.468
73849150|NCT03856359|147244078|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
73849151|NCT01664247|147244084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34|||<|0.0001|TWO_SIDED|95.0|-2.67|-2.01|||ANOVA||The treatment contrast estimated was IDeg - Placebo.|The pre-breakfast measures of SMPG values after 26 weeks of treatment were analysed an ANOVA method with treatment, region and sex as fixed effects, and age and baseline response as covariates.||-2.01|-2.67|<.0001
73849152|NCT01664247|147244085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||<|0.0001|TWO_SIDED|95.0|-3.04|-2.34|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast.||-2.34|-3.04|<.0001
74023730|NCT01381094|147600238|SUPERIORITY||||||=|0.7385|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7385
73849153|NCT01664247|147244085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.09|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.48|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after breakfast.||-1.48|-2.71|<.0001
73849154|NCT01664247|147244085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01|||<|0.0001|TWO_SIDED|95.0|-2.47|-1.56|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before lunch.||-1.56|-2.47|<.0001
73849155|NCT01664247|147244085|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.93|||<|0.0001|TWO_SIDED|95.0|-2.46|-1.4|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after start of lunch.||-1.40|-2.46|<.0001
73849156|NCT01664247|147244085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point main evening meal.||-1.23|-2.25|<.0001
73849157|NCT01664247|147244085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.26|-1.18|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after main evening meal.||-1.18|-2.26|<.0001
73849158|NCT01664247|147244085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.27|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before bedtime.||-1.23|-2.27|<.0001
73849159|NCT01664247|147244085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-2.91|-2.09|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast the following day.||-2.09|-2.91|<.0001
73849160|NCT01106157|147244090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.277|STANDARD_ERROR_OF_MEAN|0.134||0.017|TWO_SIDED|95.0|0.001|0.552|||t-test, 2 sided|||||0.552|0.001|0.017
73849161|NCT01106157|147244091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.104||0.43|TWO_SIDED|95.0|-0.3|0.13|||t-test, 2 sided|||||0.13|-0.30|0.43
73960964|NCT01152190|147457852|SUPERIORITY_OR_OTHER||Difference in LS Means|7.93|STANDARD_ERROR_OF_MEAN|5.199||0.131||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.131
74023731|NCT01381094|147600238|SUPERIORITY||||||=|0.0176|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0176
73960965|NCT03505099|147457869|SUPERIORITY||Difference of Proportion|76.5|||<|0.0001|TWO_SIDED|95.0|50.95|92.21|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al, 2014 - PubMed 25080519) where 19 out of 81 participants (23.46%) with 3 copies of SMN2 achieved standing alone for at least 3 seconds.|92.21|50.95|<0.0001
74023732|NCT01381094|147600238|SUPERIORITY||||||=|0.0057|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0057
74023733|NCT01381094|147600238|SUPERIORITY||||||=|0.5551|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5551
74023734|NCT01381094|147600238|SUPERIORITY||||||=|0.0086|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0086
74023735|NCT01381094|147600238|SUPERIORITY||||||=|0.2385|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2385
73849162|NCT01106157|147244092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.7||0.37|TWO_SIDED|95.0|-1.64|0.63|||t-test, 2 sided|||||0.63|-1.64|0.37
73849163|NCT01106157|147244093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.064|STANDARD_ERROR_OF_MEAN|0.16||0.69|TWO_SIDED|95.0|-0.4|0.27|||t-test, 2 sided|||||0.27|-0.40|0.69
73960966|NCT03505099|147457870|SUPERIORITY||Difference of Proportion|73.9|||<|0.0001|TWO_SIDED|95.0|44.67|91.61|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 6 out of 23 participants (26.09%) with 2 copies of SMN2 were alive and did not require permanent ventilation.|91.61|44.67|<0.0001
73849164|NCT01106157|147244094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.75|STANDARD_ERROR_OF_MEAN|81.3||0.89|TWO_SIDED|95.0|-156.8|180.3|||t-test, 2 sided|||||180.3|-156.8|0.89
73849165|NCT01106157|147244095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.21||0.2|TWO_SIDED|95.0|-0.15|0.7|||t-test, 2 sided|||||0.70|-0.15|0.2
73960967|NCT03505099|147457872|SUPERIORITY||Difference of Proportion|72.3|||<|0.0001|TWO_SIDED|95.0|44.9|90.11|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al, 2014 - PubMed 25080519) where 17 out of 81 participants (20.99%) with 3 copies of SMN2 achieved the ability to walk alone.|90.11|44.90|<0.0001
74023736|NCT01381094|147600238|SUPERIORITY||||||=|0.0007|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0007
74023737|NCT01381094|147600238|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0002
74023738|NCT01381094|147600238|SUPERIORITY||||||=|0.8895|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8895
74023739|NCT01381094|147600238|SUPERIORITY||||||=|0.0127|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0127
73849166|NCT01106157|147244096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.13|STANDARD_ERROR_OF_MEAN|19.61||0.23|TWO_SIDED|95.0|-64.8|16.7|||t-test, 2 sided|||||16.7|-64.8|0.23
73849167|NCT01106157|147244097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.1||0.79|TWO_SIDED|95.0|-0.18|0.23|||t-test, 2 sided|||||0.23|-0.18|0.79
73849168|NCT01106157|147244098|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.67|STANDARD_ERROR_OF_MEAN|5.33||0.163|TWO_SIDED|95.0|-18.7|3.35|||t-test, 2 sided|||||3.35|-18.7|0.163
73849169|NCT02141672|147244132|SUPERIORITY||Odds Ratio (OR)|2.03||||0.045|TWO_SIDED|95.0|1.01|4.05|||Regression, Logistic|||Voclosporin low dose vs. placebo||4.05|1.01|0.045
73849170|NCT02141672|147244132|SUPERIORITY||Odds Ratio (OR)|1.59||||0.204|TWO_SIDED|95.0|0.78|3.27|||Regression, Logistic|||Voclosporin high dose vs. placebo||3.27|0.78|0.204
73849171|NCT02141672|147244133|SUPERIORITY||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|1.68|6.13|||Regression, Logistic|||Voclosporin low dose vs. placebo||6.13|1.68|<0.001
73849172|NCT02141672|147244133|SUPERIORITY||Odds Ratio (OR)|2.1||||0.026|TWO_SIDED|95.0|1.09|4.02|||Regression, Logistic|||Voclosporin high dose vs. placebo||4.02|1.09|0.026
73849173|NCT02141672|147244134|SUPERIORITY||Odds Ratio (OR)|1.9||||0.066|TWO_SIDED|95.0|0.96|3.78|||Regression, Logistic|||||3.78|0.96|0.066
73849174|NCT02141672|147244134|SUPERIORITY||Odds Ratio (OR)|1.64||||0.162|TWO_SIDED|95.0|0.82|3.28|||Regression, Logistic|||||3.28|0.82|0.162
73849175|NCT02141672|147244135|SUPERIORITY||Hazard Ratio (HR)|2.26|||<|0.001|TWO_SIDED|95.0|1.45|3.51|||Regression, Cox|||Voclosporin low dose vs. placebo||3.51|1.45|<0.001
73849176|NCT02141672|147244135|SUPERIORITY||Hazard Ratio (HR)|2.25|||<|0.001|TWO_SIDED|95.0|1.46|3.47|||Regression, Cox|||Voclosporin high dose vs. placebo||3.47|1.46|<0.001
73849177|NCT02141672|147244136|SUPERIORITY||Hazard Ratio (HR)|2.89|||<|0.001|TWO_SIDED|95.0|1.58|5.29|||Regression, Cox|||||5.29|1.58|<0.001
73849178|NCT02141672|147244136|SUPERIORITY||Hazard Ratio (HR)|1.48|||<|0.248|TWO_SIDED|95.0|0.77|2.86|||Regression, Cox|||Voclosporin high dose vs. placebo||2.86|0.77|<0.248
74023740|NCT01381094|147600238|SUPERIORITY||||||=|0.0076|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0076
73960968|NCT01420549|147457902|NON_INFERIORITY|The non-inferiority assessment was analyzed by the bilateral confidence interval (95%) for the ratio of the mean LDLfinal/LDLbaseline of the R/E combination, compared to the mean LDLfinal/LDLbaseline of the S/E combination and the bilateral confidence interval (95%) for the difference between the two means of the percentage variation of LDL-C in the treatments (\[(LDLfinal - LDLbaseline)/LDLbaseline))\*100)R+E\] - \[(LDLfinal - LDLbaseline)/LDLbaseline))\*100)S+E\].|Median Difference (Final Values)|-10.32|STANDARD_ERROR_OF_MEAN|3.33||0.0013|TWO_SIDED|95.0|-16.94|-3.7|||ANCOVA|Estimates for treatment effect and their 95% confidence intervals were exponentiated to produce estimates of percentage change.|Mean Percentage Change LDL- C (%)|Rosuvastatin + Ezetimibe versus Simvastatin + Ezetimibe||-3.70|-16.94|0.0013
73960969|NCT05219253|147457918|SUPERIORITY|The superiority was to be concluded if the lower limit (LL) of the 95% confidence interval (CI) of the adjusted GMC ratio between the HZ/su Group and Placebo Group for anti-gE antibody concentrations was equal to or above (\>=) 3.|GMC Ratio|19.8|||||TWO_SIDED|95.0|14.09|27.82|||ANOVA|||To demonstrate the immunogenicity of HZ/su vaccine compared to Placebo, in terms of anti-gE GMCs, at 1 month post-Dose 2 of study intervention administration (Month 3).||27.82|14.09|
73960970|NCT03086369|147457930|SUPERIORITY||Hazard Ratio (HR)|1.054||||0.7902|TWO_SIDED|95.0|0.728|1.527|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|||1.527|0.728|0.7902
73960971|NCT03086369|147457934|SUPERIORITY||Hazard Ratio (HR)|1.192||||0.3771|TWO_SIDED|95.0|0.806|1.764|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|||1.764|0.806|0.3771
73960972|NCT03086369|147457937|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.017|TWO_SIDED|95.0|0.175|0.872|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).||||0.872|0.175|0.017
73960973|NCT03086369|147457938|SUPERIORITY||Hazard Ratio (HR)|0.718||||0.288|TWO_SIDED|95.0|0.392|1.317|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Appetite loss||1.317|0.392|0.288
73960974|NCT03086369|147457938|SUPERIORITY||Hazard Ratio (HR)|0.788||||0.442|TWO_SIDED|95.0|0.423|1.468|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Constipation||1.468|0.423|0.442
73960975|NCT03086369|147457938|SUPERIORITY||Hazard Ratio (HR)|1.037||||0.883|TWO_SIDED|95.0|0.612|1.755|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Diarrhoea||1.755|0.612|0.883
73960976|NCT03086369|147457938|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.803|TWO_SIDED|95.0|0.532|1.636|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Dyspnoea||1.636|0.532|0.803
73960977|NCT03086369|147457938|SUPERIORITY||Hazard Ratio (HR)|1.053||||0.805|TWO_SIDED|95.0|0.675|1.645|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Fatigue||1.645|0.675|0.805
73960978|NCT03086369|147457938|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.465|TWO_SIDED|95.0|0.42|1.464|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Financial difficulties||1.464|0.420|0.465
73960979|NCT03086369|147457938|SUPERIORITY||Hazard Ratio (HR)|1.457||||0.231|TWO_SIDED|95.0|0.787|2.698|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Insomnia||2.698|0.787|0.231
73960980|NCT03086369|147457938|SUPERIORITY||Hazard Ratio (HR)|0.914||||0.748|TWO_SIDED|95.0|0.532|1.57|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Nausea and vomiting||1.570|0.532|0.748
73960981|NCT03086369|147457938|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.875|TWO_SIDED|95.0|0.491|1.827|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Pain||1.827|0.491|0.875
73960982|NCT01904071|147457940|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
73960983|NCT01904071|147457941|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<.05
73960984|NCT01904071|147457942|SUPERIORITY_OR_OTHER||||||<|0.005|||||||ANOVA|||||||<.005
73960985|NCT01904071|147457943|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<.001
73960986|NCT01904071|147457944|SUPERIORITY_OR_OTHER|||||||0.342|||||||ANOVA|||||||0.342
73960987|NCT01765543|147457957|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.614|||||TWO_SIDED|90.0|0.484|0.78||||||Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||0.780|0.484|
73960988|NCT01765543|147457958|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.596|||||TWO_SIDED|90.0|0.469|0.759||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||0.759|0.469|
73960989|NCT01765543|147457959|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.908|1.36||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||1.36|0.908|
73960990|NCT01424397|147457965|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with FP alone compared to Placebo using Mixed Models Analysis was 1.0000|||
73960991|NCT01424397|147457965|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 alone compared to Placebo using Mixed Models Analysis was 0.7127|||
74023741|NCT01381094|147600238|SUPERIORITY||||||=|0.0007|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0007
74023742|NCT01381094|147600238|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
73960992|NCT01424397|147457965|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to Placebo using Mixed Models Analysis was 1.0000|||
73960993|NCT01424397|147457965|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to FP alone using Mixed Models Analysis was 0.0160|||
73960994|NCT01424397|147457967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.35|STANDARD_ERROR_OF_MEAN|12.56|||TWO_SIDED|90.0|60.54|102.15||||||Placebo versus FP 200 μg,Nasal Airflow resistance Total WM,0-4 hr||102.15|60.54|
73960995|NCT01424397|147457967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.31|STANDARD_ERROR_OF_MEAN|19.548|||TWO_SIDED|90.0|-39.7|25.05||||||Placebo versus FP 12 mg SB-705498 , Nasal Airflow resistance Total WM, 0-4 hr||25.05|-39.7|
74023743|NCT01381094|147600238|SUPERIORITY||||||=|0.5522|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5522
74023744|NCT01381094|147600238|SUPERIORITY||||||=|0.0031|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0031
73849179|NCT02141672|147244138|SUPERIORITY||Hazard Ratio (HR)|1.63||||0.005|TWO_SIDED|95.0|1.16|2.27|||Regression, Cox|||||2.27|1.16|0.005
73960996|NCT01424397|147457967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|72.4|STANDARD_ERROR_OF_MEAN|14.567|||TWO_SIDED|90.0|48.28|96.52||||||Placebo versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr||96.52|48.28|
73960997|NCT01424397|147457967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.95|STANDARD_ERROR_OF_MEAN|14.592|||TWO_SIDED|90.0|-33.1|15.22||||||FP 200 μg versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr||15.22|-33.1|
73960998|NCT01424397|147457968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.113|||TWO_SIDED|90.0|-0.87|-0.49||||||||-0.49|-0.87|
73960999|NCT01424397|147457968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.173|||TWO_SIDED|90.0|-0.3|0.27||||||||0.27|-0.30|
73961000|NCT01424397|147457968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.74|-0.31||||||||-0.31|-0.74|
73961001|NCT01424397|147457968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.06|0.37||||||||0.37|-0.06|
73961002|NCT02755805|147457985|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|1.11||||0.007|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|"F(3,74)=4.37~P-values were calculated using mixed model analyses and controlled for stoke severity as a covariate."|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||0.007
73961003|NCT02755805|147457986|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|0.76||||0.09|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|F(2,34)=2.55|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||0.09
73849180|NCT02141672|147244138|SUPERIORITY||Hazard Ratio (HR)|1.74||||0.002|TWO_SIDED|95.0|1.25|2.43|||Regression, Cox|||Voclosporin high dose vs. placebo||2.43|1.25|0.002
73849181|NCT02141672|147244140|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED|95.0|0.45|2.15|||Regression, Cox|||Voclosporin low dose vs. placebo||2.15|0.45|0.980
73849182|NCT02141672|147244140|SUPERIORITY||Hazard Ratio (HR)|1.98||||0.118|TWO_SIDED|95.0|0.95|4.16|||Regression, Cox|||Voclosporin high dose vs. placebo||4.16|0.95|0.118
73849183|NCT02141672|147244142|SUPERIORITY||Odds Ratio (OR)|2.33||||0.007|TWO_SIDED|95.0|1.26|4.33|||Regression, Logistic|||week 24||4.33|1.26|0.007
73849184|NCT02141672|147244142|SUPERIORITY||Odds Ratio (OR)|2.03||||0.024|TWO_SIDED|95.0|1.1|3.76|||Regression, Logistic|||week 24||3.76|1.1|0.024
73849185|NCT02141672|147244142|SUPERIORITY||Odds Ratio (OR)|2.34||||0.007|TWO_SIDED|95.0|1.27|4.33|||Regression, Logistic|||week 48||4.33|1.27|0.007
73849186|NCT02141672|147244142|SUPERIORITY||Odds Ratio (OR)|2.68||||0.002|TWO_SIDED|95.0|1.43|5.02|||Regression, Logistic|||week 48||5.02|1.43|0.002
73849187|NCT02141672|147244143|SUPERIORITY||Hazard Ratio (HR)|2.03|||<|0.001|TWO_SIDED|95.0|1.36|3.03|||Regression, Cox|||Voclosporin low dose vs. placebo||3.03|1.36|<0.001
73849188|NCT02141672|147244143|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.004|TWO_SIDED|95.0|1.22|2.69|||Regression, Cox|||Voclosporin high dose vs. placebo||2.69|1.22|0.004
73961004|NCT02755805|147457987|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|1.23||||0.002|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|F(2,34)=7.83|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to assigned intervention group regardless of study completion.||||.002
73849189|NCT02141672|147244145|SUPERIORITY||Hazard Ratio (HR)|2.21|||<|0.001|TWO_SIDED|95.0|1.45|3.36|||Regression, Cox|||Voclosporin low dose vs. placebo||3.36|1.45|<0.001
73849190|NCT02141672|147244145|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.004|TWO_SIDED|95.0|1.23|2.84|||Regression, Cox|||Voclosporin high dose vs. placebo||2.84|1.23|0.004
73849191|NCT01118780|147244149|SUPERIORITY_OR_OTHER||LS mean difference|4.17|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|2.47|5.88|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||5.88|2.47|<0.001
73849192|NCT01118780|147244150|SUPERIORITY_OR_OTHER||LS mean difference|3.23|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|1.61|4.85|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||4.85|1.61|<0.001
73849193|NCT01118780|147244151|SUPERIORITY_OR_OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|1.43|3.37||The p-value is for the change from baseline to Week 10 in the HAMA Psychic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||3.37|1.43|<0.001
73849194|NCT01118780|147244151|SUPERIORITY_OR_OTHER||LS mean difference|1.76|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|0.87|2.65||The p-value is for the change from baseline to Week 10 in the HAMA Somatic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||2.65|0.87|<0.001
73849195|NCT01118780|147244151|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.3|0.74||The p-value is for the change from baseline to Week 10 in the HAMA Anxious Mood Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.74|0.30|<0.001
73849196|NCT01118780|147244151|SUPERIORITY_OR_OTHER||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.11||0.007|TWO_SIDED|95.0|0.09|0.53||The p-value is for the change from baseline to Week 10 in the HAMA Tension Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.53|0.09|0.007
73849197|NCT01118780|147244152|SUPERIORITY_OR_OTHER||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.2|3.18||The p-value is for the change from baseline to Week 10 in the HADS Anxiety Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||3.18|1.20|<0.001
73849198|NCT01118780|147244152|SUPERIORITY_OR_OTHER||LS mean difference|1.69|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|0.89|2.49||The p-value is for the change from baseline to Week 10 in the HADS Depression Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||2.49|0.89|<0.001
73849199|NCT01118780|147244153|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.26|0.79|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.79|0.26|<0.001
73849200|NCT01118780|147244154|SUPERIORITY_OR_OTHER||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|0.33|0.91|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.91|0.33|<0.001
73849201|NCT01118780|147244155|SUPERIORITY_OR_OTHER||LS mean difference|0.55|STANDARD_ERROR_OF_MEAN|0.29||0.059|TWO_SIDED|95.0|-0.02|1.11||The p-value is for the change from baseline to Week 10 in BPI-SF Worst Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.11|-0.02|0.059
73849202|NCT01118780|147244155|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.24||0.079|TWO_SIDED|95.0|-0.05|0.89||The p-value is for the change from baseline to Week 10 in BPI-SF Least Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.89|-0.05|0.079
73849203|NCT01118780|147244155|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.25||0.089|TWO_SIDED|95.0|-0.06|0.91||The p-value is for the change from baseline to Week 10 in BPI-SF Average Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.91|-0.06|0.089
73849204|NCT01118780|147244155|SUPERIORITY_OR_OTHER||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.371|TWO_SIDED|95.0|-0.27|0.73||The p-value is for the change from baseline to Week 10 in BPI-SF Pain Right Now Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.73|-0.27|0.371
73849205|NCT01118780|147244155|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.29||0.066|TWO_SIDED|95.0|-0.04|1.09||The p-value is for the change from baseline to Week 10 in BPI-SF General Activity Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.09|-0.04|0.066
73849206|NCT01118780|147244155|SUPERIORITY_OR_OTHER||LS mean difference|0.41|STANDARD_ERROR_OF_MEAN|0.27||0.14|TWO_SIDED|95.0|-0.13|0.95||The p-value is for the change from baseline to Week 10 in BPI-SF Mood Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.95|-0.13|0.140
74023745|NCT01381094|147600238|SUPERIORITY||||||=|0.2188|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2188
73961005|NCT02755805|147457988|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|0.7||||0.04|TWO_SIDED|||||a priori threshold set at \<0.05|repeated measures fixed effects model|F(2,28)=3.61|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||.04
73961006|NCT02252042|147457993|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0316|TWO_SIDED|95.0|0.67|1.01|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.01|0.67|0.03160
73961007|NCT02252042|147457994|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.01605|TWO_SIDED|95.0|0.65|0.98||Nominal p-value|Log Rank||Nominal HR. Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||0.98|0.65|0.01605
73961008|NCT02252042|147457995|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00493|TWO_SIDED|95.0|0.58|0.93|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||0.93|0.58|0.00493
73961009|NCT02252042|147457996|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.32504|TWO_SIDED|95.0|0.79|1.16|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.16|0.79|0.32504
73961010|NCT02252042|147457997|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07736|TWO_SIDED|95.0|0.69|1.06|||Log Rank||Cox regression model with treatment as a single covariate|||1.06|0.69|0.07736
73961011|NCT02252042|147457998|SUPERIORITY||Difference in percentages|4.6||||0.061|TWO_SIDED|95.0|-1.2|10.6|||Log Rank|H0: difference in %=0; H1: difference in %\>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||10.6|-1.2|0.0610
73961012|NCT02252042|147457999|SUPERIORITY||Difference in percentages|7.5||||0.0171|TWO_SIDED|95.0|0.6|14.6|||Log Rank|H0: difference in %=0; H1: difference in %\>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||14.6|0.6|0.0171
73961013|NCT02252042|147458002|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.14545|TWO_SIDED|95.0|0.7|1.12||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.12|0.70|0.14545
74023746|NCT01381094|147600238|SUPERIORITY||||||=|0.0054|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0054
74023747|NCT01381094|147600238|SUPERIORITY||||||=|0.0037|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0037
73961014|NCT02252042|147458003|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.05851|TWO_SIDED|95.0|0.62|1.06||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.06|0.62|0.05851
73961015|NCT02252042|147458004|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.65759|TWO_SIDED|95.0|0.86|1.27|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.27|0.86|0.65759
73961016|NCT02252042|147458005|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.51982|TWO_SIDED|95.0|0.81|1.26|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.26|0.81|0.51982
73961017|NCT02658240|147458019|SUPERIORITY|||||||0.05|||||||ANOVA|||The study was powered to detect a mean difference of 1.5 in pain scores in favor of patients undergoing SFICB procedure assuming a standard deviation of 2.5. With a two sided alpha level of 0.05, a total of 52 patients would be needed to have 80% power using a repeated measures ANOVA F test with 6 observations on each subject. Correlation on the repeat observations was assumed to be 0.5. Assuming a 14% loss to follow-up, 60 patients were enrolled at 1:1 ratio.||||0.05
73961018|NCT02658240|147458020|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
73961019|NCT02658240|147458021|SUPERIORITY|||||||0.149|TWO_SIDED|80.0|||||t-test, 2 sided|||||||0.149
73961020|NCT02658240|147458022|SUPERIORITY|||||||0.584|TWO_SIDED|80.0|||||Wilcoxon (Mann-Whitney)|||||||0.584
73961021|NCT03691428|147458023|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
73961022|NCT03691428|147458024|SUPERIORITY|A multivariate dyadic linear growth curve model was used to predict the trajectories of psychological well-being (Raudenbush, Brennan, \& Barnett, 1995).|||||<|0.05|||||||Mixed Models Analysis|||||||<.05
74023748|NCT01381094|147600238|SUPERIORITY||||||=|0.9521|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9521
74023749|NCT01381094|147600239|SUPERIORITY||||||=|0.3943|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.3943
74023750|NCT01381094|147600239|SUPERIORITY||||||=|0.2096|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.2096
73961023|NCT03691428|147458025|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
73961024|NCT03691428|147458026|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
73961025|NCT03691428|147458027|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
73961026|NCT02527148|147458028|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 weeks for the control cases||||<0.0001
73961027|NCT02527148|147458028|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 weeks for the Shapematch cases||||<0.0001
74023751|NCT01381094|147600239|SUPERIORITY||||||=|0.0637|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0637
74023752|NCT01381094|147600239|SUPERIORITY||||||=|0.5016|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.5016
74023753|NCT01381094|147600239|SUPERIORITY||||||=|0.7549|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.7549
74023754|NCT01381094|147600239|SUPERIORITY||||||=|0.5991|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5991
73961028|NCT02527148|147458028|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 6 weeks between both groups.||||0.0004
73961029|NCT02527148|147458028|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 months for Control cases.||||<0.0001
73961030|NCT02527148|147458028|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement form preoperative to 6 months for Shapematch cases.||||<0.0001
73961031|NCT02527148|147458028|SUPERIORITY|||||||0.3894|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 6 months between both groups.||||0.3894
73961032|NCT02527148|147458028|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 12 months for the Control cases||||<0.0001
73961033|NCT02527148|147458028|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 12 months for the Shapematch cases||||<0.0001
73961034|NCT02527148|147458028|SUPERIORITY|||||||0.4387|||||||t-test, 2 sided|p-values from repeated ANOVA with change from preoperative variable/scores as dependent variable.||To compare improvement of OKS from preoperative to 12 months between both groups.||||0.4387
73961035|NCT02527148|147458028|SUPERIORITY|||||||0.261|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 2 years between both groups.||||0.2610
73961036|NCT02527148|147458028|SUPERIORITY|||||||0.8458|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 5 years between both groups.||||0.8458
73961037|NCT02527148|147458029|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||To compare mean duration of surgery between both groups.||||0.10
74023755|NCT01381094|147600239|SUPERIORITY||||||=|0.4258|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.4258
73961038|NCT02527148|147458030|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||To compare wound length between both groups.||||0.05
73961039|NCT02527148|147458032|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||To compare average length of hospital stay between both groups.||||0.07
73961040|NCT02527148|147458033|SUPERIORITY||Mean Difference (Final Values)|-0.023||||0.55|TWO_SIDED||||||t-test, 2 sided|||Comparison of baseline differences||||0.55
73961041|NCT02527148|147458033|SUPERIORITY||Mean Difference (Final Values)|-0.043||||0.23|TWO_SIDED||||||t-test, 2 sided|||Analysis of QALY between each instrument platform at 12-months||||0.23
73961042|NCT02527148|147458034|EQUIVALENCE|To determine equivalence in baseline characteristics between the control and intervention group.||||||0.724|||||||t-test, 2 sided|||To compare VAS rest preoperatively between both groups.||||0.7240
73961043|NCT02527148|147458034|EQUIVALENCE|To determine equivalence in baseline characteristics between the control and intervention group.||||||0.7545|||||||t-test, 2 sided|||To compare VAS mobilisation preoperatively between both groups.||||0.7545
73961044|NCT02527148|147458034|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.6921|||||||t-test, 2 sided|||To compare VAS rest at 6 weeks between both groups.||||0.6921
73961045|NCT02527148|147458034|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.9601|||||||t-test, 2 sided|||To compare VAS mobilisation at 6 weeks between both groups.||||0.9601
73961046|NCT02527148|147458034|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.0697|||||||t-test, 2 sided|||To compare VAS rest at 6 months between both groups.||||0.0697
73961047|NCT02527148|147458034|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.0342|||||||t-test, 2 sided|||To compare VAS mobilisation at 6 months between both groups.||||0.0342
73961048|NCT02527148|147458034|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.3487|||||||t-test, 2 sided|||To compare VAS rest at 12 months between both groups.||||0.3487
73961049|NCT02527148|147458034|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.2201|||||||t-test, 2 sided|||To compare VAS mobilisation at 1 year between both groups.||||0.2201
73961050|NCT02527148|147458034|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.2291|||||||t-test, 2 sided|||To compare VAS rest at 2 years between both groups.||||0.2291
73961051|NCT02527148|147458034|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.6436|||||||t-test, 2 sided|||To compare VAS mobilisation at 2 years between both groups.||||0.6436
73961052|NCT02527148|147458034|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.4344|||||||t-test, 2 sided|||To compare VAS rest at 5 years between both groups.||||0.4344
73961053|NCT02527148|147458034|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.8732|||||||t-test, 2 sided|||To compare VAS mobilisation at 5 years between both groups.||||0.8732
73849207|NCT01118780|147244155|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.29||0.04|TWO_SIDED|95.0|0.03|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Walking Ability Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.18|0.03|0.040
73849208|NCT01118780|147244155|SUPERIORITY_OR_OTHER||LS mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.29||0.187|TWO_SIDED|95.0|-0.19|0.94||The p-value is for the change from baseline to Week 10 in BPI-SF Normal Work Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.94|-0.19|0.187
73849209|NCT01118780|147244155|SUPERIORITY_OR_OTHER||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.26||0.515|TWO_SIDED|95.0|-0.34|0.68||The p-value is for the change from baseline to Week 10 in BPI-SF Relations With Other People Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.68|-0.34|0.515
73849210|NCT01118780|147244155|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.34||0.141|TWO_SIDED|95.0|-0.17|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Sleep Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.18|-0.17|0.141
73849211|NCT01118780|147244155|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.29||0.088|TWO_SIDED|95.0|-0.07|1.07||The p-value is for the change from baseline to Week 10 in BPI-SF Enjoyment of Life Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.07|-0.07|0.088
73961054|NCT02527148|147458035|SUPERIORITY|||||||0.911|||||||t-test, 2 sided|||To compare WOMAC preoperatively between both groups.||||0.911
73961055|NCT02527148|147458035|SUPERIORITY|||||||0.588|||||||t-test, 2 sided|||To compare WOMAC at 6-weeks between both groups.||||0.588
74023756|NCT01381094|147600239|SUPERIORITY||||||=|0.0336|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0336
73849212|NCT01118780|147244156|SUPERIORITY_OR_OTHER||LS mean difference|-5.76|STANDARD_ERROR_OF_MEAN|1.87||0.002|TWO_SIDED|95.0|-9.4|-2.1|||ANCOVA||LS mean difference was calculated by placebo minus duloxetine. Negative values indicated improvement over placebo.|||-2.1|-9.4|0.002
73849213|NCT01118780|147244158|SUPERIORITY_OR_OTHER||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.43||0.01|TWO_SIDED|95.0|0.27|1.98||The p-value is for the change from baseline to Week 10 in SDS for Work/School Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.98|0.27|0.010
73849214|NCT01118780|147244158|SUPERIORITY_OR_OTHER||LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|0.32|1.48||The p-value is for the change from baseline to Week 10 in SDS for Social Life/Leisure Activities Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.48|0.32|0.002
73849215|NCT01118780|147244158|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|0.61|1.81||The p-value is for the change from baseline to Week 10 in SDS for Family/Home Management Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.81|0.61|<0.001
73849216|NCT01118780|147244159|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having HAMA response at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
73961056|NCT02527148|147458035|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||To compare WOMAC at 6-months between both groups.||||0.030
73961057|NCT02527148|147458035|SUPERIORITY|||||||0.131|||||||t-test, 2 sided|||To compare WOMAC at 1-year between both groups.||||0.131
73961058|NCT02527148|147458035|SUPERIORITY|||||||0.347|||||||t-test, 2 sided|||To compare WOMAC at 2-years between both groups.||||0.347
73961059|NCT02527148|147458035|SUPERIORITY|||||||0.341|||||||t-test, 2 sided|||To compare WOMAC at 5-years between both groups.||||0.341
73961060|NCT02527148|147458036|SUPERIORITY|||||||0.452|||||||t-test, 2 sided|||To compare EQ-5D index preoperatively between both groups.||||0.452
73961061|NCT02527148|147458036|SUPERIORITY|||||||0.201|||||||t-test, 2 sided|||To compare EQ-5D VAS preoperatively between both groups.||||0.201
73961062|NCT02527148|147458036|SUPERIORITY|||||||0.741|||||||t-test, 2 sided|||To compare EQ-5D index at 6-weeks between both groups.||||0.741
73961063|NCT02527148|147458036|SUPERIORITY|||||||0.794|||||||t-test, 2 sided|||To compare EQ-5D VAS at 6-weeks between both groups.||||0.794
73961064|NCT02527148|147458036|SUPERIORITY|||||||0.232|||||||t-test, 2 sided|||To compare EQ-5D index at 6-months between both groups.||||0.232
73961065|NCT02527148|147458036|SUPERIORITY|||||||0.513|||||||t-test, 2 sided|||To compare EQ-5D VAS at 6-months between both groups.||||0.513
73961066|NCT02527148|147458036|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||To compare EQ-5D index at 1-year between both groups.||||0.180
73961067|NCT02527148|147458036|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||To compare EQ-5D VAS at 1-year between both groups.||||0.864
73961068|NCT02527148|147458036|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||To compare EQ-5D index at 2-year between both groups.||||0.223
73961069|NCT02527148|147458036|SUPERIORITY|||||||0.355|||||||t-test, 2 sided|||To compare EQ-5D VAS at 2-year between both groups.||||0.355
73961070|NCT02527148|147458036|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||To compare EQ-5D index at 5-year between both groups.||||0.314
73961071|NCT02527148|147458036|SUPERIORITY|||||||0.914|||||||t-test, 2 sided|||To compare EQ-5D VAS at 5-year between both groups.||||0.914
73961072|NCT02527148|147458037|SUPERIORITY|||||||0.523|||||||t-test, 2 sided|||To compare FJS at 6-weeks between both groups.||||0.523
73961073|NCT02527148|147458037|SUPERIORITY|||||||0.932|||||||t-test, 2 sided|||To compare FJS at 6-months between both groups.||||0.932
73961074|NCT02527148|147458037|SUPERIORITY|||||||0.934|||||||t-test, 2 sided|||To compare FJS at 1-year between both groups.||||0.934
74023757|NCT01381094|147600239|SUPERIORITY||||||=|0.0258|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0258
73849217|NCT01118780|147244159|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having remission (HAMA Total Score ≤7) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
73849218|NCT01118780|147244159|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having remission (HAMA Total Score ≤10) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
73849219|NCT01118780|147244160|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤5) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
73849220|NCT01118780|147244160|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤6) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
73849221|NCT01118780|147244161|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value is for the percentage of participants having HAMA sustained improvement overall and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||0.001
73849222|NCT01118780|147244161|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||The p-value is for the percentage of participants having HAMA sustained improvement from Week 2 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||0.038
73849223|NCT01118780|147244165|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||0.005
73849224|NCT01118780|147244166|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the time to first remission (HAMA Total Score ≤10) and was adjusted for pooled investigator.|Log Rank|||||||<0.001
73849225|NCT01118780|147244167|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||0.001
74023758|NCT01381094|147600239|SUPERIORITY||||||=|0.2412|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.2412
74023759|NCT01381094|147600239|SUPERIORITY||||||=|0.0031|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0031
73849226|NCT01118780|147244168|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||The p-value is for the time to first functional remission (SDS Global Functional Impairment Score ≤5) and was adjusted for pooled investigator.|Log Rank|||||||0.006
73849227|NCT01118780|147244168|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The p-value is for time to first functional remission (SDS Global Functional Impairment Score ≤6) and was adjusted for pooled investigator.|Log Rank|||||||0.003
73849228|NCT01118780|147244169|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||<0.001
73849229|NCT05018689|147244179|SUPERIORITY||Mean Difference (Net)|0.04||||0.642|TWO_SIDED|95.0|-0.13|0.22|||Regression, Linear|||How confident to identify someone showing depression?||0.22|-0.13|0.642
73849230|NCT05018689|147244179|SUPERIORITY||Mean Difference (Net)|0.02||||0.864|TWO_SIDED|95.0|-0.21|0.25|||Regression, Linear|||How confident to help a friend?||0.25|-0.21|0.864
73849231|NCT05018689|147244180|SUPERIORITY||comparison of odds ratios|0.78||||0.336|TWO_SIDED|95.0|0.47|1.3|||Regression, Logistic|||||1.30|0.47|0.336
73849232|NCT05018689|147244181|SUPERIORITY||comparison of odds ratios|1.05||||0.806|TWO_SIDED|95.0|0.7|1.59|||Regression, Logistic|||Depression runs in families. Answer: true||1.59|0.70|0.806
73849233|NCT05018689|147244181|SUPERIORITY||comparison of odds ratios|0.96||||0.781|TWO_SIDED|95.0|0.71|1.3|||Regression, Logistic|||Depression can be controlled through willpower. Answer: false||1.30|0.71|0.781
73849234|NCT05018689|147244181|SUPERIORITY||comparison of odds ratios|0.93||||0.72|TWO_SIDED|95.0|0.62|1.39|||Regression, Logistic|||Depression is treatable. Answer: true||1.39|0.62|0.720
73849235|NCT05018689|147244181|SUPERIORITY||comparison of odds ratios|1.11||||0.784|TWO_SIDED|95.0|0.52|2.38|||Regression, Logistic|||Abuse of alcohol and drugs can be a sign of depression. Answer: true||2.38|0.52|0.784
73849236|NCT05018689|147244181|SUPERIORITY||comparison of odds ratios|1.08||||0.662|TWO_SIDED|95.0|0.76|1.55|||Regression, Logistic|||Depression is a sign of personal weakness. Answer: false||1.55|0.76|0.662
73849237|NCT05018689|147244182|SUPERIORITY||comparison of odds ratios|0.8||||0.34|TWO_SIDED|95.0|0.51|1.26|||Regression, Logistic|||Difficulty concentrating or making decisions||1.26|0.51|0.340
73849238|NCT05018689|147244182|SUPERIORITY||comparison of odds ratios|0.81||||0.265|TWO_SIDED|95.0|0.56|1.17|||Regression, Logistic|||Feeling angry||1.17|0.56|0.265
73849239|NCT05018689|147244182|SUPERIORITY||comparison of odds ratios|0.7||||0.259|TWO_SIDED|95.0|0.38|1.3|||Regression, Logistic|||Changes in sleep patterns||1.30|0.38|0.259
73849240|NCT05018689|147244182|SUPERIORITY||comparison of odds ratios|1.12||||0.45|TWO_SIDED|95.0|0.84|1.49|||Regression, Logistic|||Frequent unexplained aches and pains||1.49|0.84|0.450
73849241|NCT05018689|147244182|SUPERIORITY||comparison of odds ratios|2.28||||0.025|TWO_SIDED|95.0|1.11|4.69|||Regression, Logistic|||Feeling tired or less energetic||4.69|1.11|0.025
73849242|NCT05018689|147244182|SUPERIORITY||comparison of odds ratios|1.01||||0.937|TWO_SIDED|95.0|0.71|1.44|||Regression, Logistic|||Eating more than usual||1.44|0.71|0.937
73849243|NCT05018689|147244182|SUPERIORITY||comparison of odds ratios|0.83||||0.447|TWO_SIDED|95.0|0.52|1.34|||Regression, Logistic|||Feeling irritable or restless||1.34|0.52|0.447
73849244|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|0.02||||0.8|TWO_SIDED|95.0|-0.11|0.14|||Regression, Linear|||Friend||0.14|-0.11|0.800
73849245|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|-0.05||||0.451|TWO_SIDED|95.0|-0.18|0.08|||Regression, Linear|||Parent/guardian||0.08|-0.18|0.451
73849246|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|0.07||||0.335|TWO_SIDED|95.0|-0.07|0.2|||Regression, Linear|||School counselor||0.2|-0.07|0.335
73849247|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|-0.04||||0.554|TWO_SIDED|95.0|-0.17|0.09|||Regression, Linear|||Teacher||0.09|-0.17|0.554
73961075|NCT02527148|147458037|SUPERIORITY|||||||0.566|||||||t-test, 2 sided|||To compare FJS at 2-year between both groups.||||0.566
73961076|NCT02527148|147458037|SUPERIORITY|||||||0.263|||||||t-test, 2 sided|||To compare FJS at 5-year between both groups.||||0.263
73961077|NCT02527148|147458038|SUPERIORITY|||||||0.3768|||||||t-test, 2 sided|||To compare IKSS Pain preoperatively between both groups.||||0.3768
73849248|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|-0.04||||0.541|TWO_SIDED|95.0|-0.19|0.1|||Regression, Linear|||Mental health professional||0.10|-0.19|0.541
73849249|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|0.05||||0.454|TWO_SIDED|95.0|-0.09|0.19|||Regression, Linear|||Doctor||0.19|-0.09|0.454
73849250|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|-0.02||||0.749|TWO_SIDED|95.0|-0.16|0.12|||Regression, Linear|||Internet/website||0.12|-0.16|0.749
73849251|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|-0.13||||0.03|TWO_SIDED|95.0|-0.24|-0.01|||Regression, Linear|||Clergy, priest, rabbi, or other religious person||-0.01|-0.24|0.030
73849252|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|0.06||||0.334|TWO_SIDED|95.0|-0.06|0.18|||Regression, Linear|||Phone helpline||0.18|-0.06|0.334
73849253|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|0.07||||0.243|TWO_SIDED|95.0|-0.05|0.2|||Regression, Linear|||Crisis textline||0.20|-0.05|0.243
73849254|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|-0.05||||0.492|TWO_SIDED|95.0|-0.19|0.09|||Regression, Linear|||Other relative (i.e., sister, brother, aunt, uncle)||0.09|-0.19|0.492
73849255|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|-0.04||||0.61|TWO_SIDED|95.0|-0.17|0.1|||Regression, Linear|||Boyfriend or girlfriend||0.10|-0.17|0.610
73849256|NCT05018689|147244183|SUPERIORITY||Mean Difference (Net)|-0.12||||0.061|TWO_SIDED|95.0|-0.25|0.01|||Regression, Linear|||Coach||0.01|-0.25|0.061
73849257|NCT05018689|147244184|SUPERIORITY||comparison of odds ratios|1.27||||0.086|TWO_SIDED|95.0|0.97|1.66|||Regression, Logistic|||If you had depression symptoms for more than 2 weeks, would you ask for help?||1.66|0.97|0.086
73849258|NCT05018689|147244184|SUPERIORITY||comparison of odds ratios|1.13||||0.526|TWO_SIDED|95.0|0.77|1.66|||Regression, Logistic|||If you thought you had mental health issues, is there a trusted adult you would go to?||1.66|0.77|0.526
73849259|NCT05018689|147244185|SUPERIORITY||Mean Difference (Net)|0.06||||0.199|TWO_SIDED|95.0|-0.03|0.16|||Regression, Linear|||Do you know how to get help in your school?||0.16|-0.03|0.199
73849260|NCT05018689|147244186|SUPERIORITY||Mean Difference (Net)|-0.25|||<|0.001|TWO_SIDED|95.0|-0.38|-0.12|||Regression, Linear|||The new student is more dangerous than other students||-0.12|-0.38|<0.001
73849261|NCT05018689|147244186|SUPERIORITY||Mean Difference (Net)|-0.18||||0.003|TWO_SIDED|95.0|-0.29|-0.06|||Regression, Linear|||The student is to blame for his or her condition||-0.06|-0.29|0.003
73849262|NCT05018689|147244186|SUPERIORITY||Mean Difference (Net)|0.06||||0.31|TWO_SIDED|95.0|-0.06|0.18|||Regression, Linear|||I would have sympathy for the new student||0.18|-0.06|0.310
73849263|NCT05018689|147244186|SUPERIORITY||Mean Difference (Net)|-0.1||||0.114|TWO_SIDED|95.0|-0.21|0.02|||Regression, Linear|||The new student makes me feel scared||0.02|-0.21|0.114
73849264|NCT05018689|147244186|SUPERIORITY||Mean Difference (Net)|0.02||||0.738|TWO_SIDED|95.0|-0.1|0.15|||Regression, Linear|||The new student makes me feel uncomfortable||0.15|-0.10|0.738
73849265|NCT05018689|147244186|SUPERIORITY||Mean Difference (Net)|0.12||||0.04|TWO_SIDED|95.0|0.01|0.24|||Regression, Linear|||I would help the new student even if I did not know him or her well||0.24|0.01|0.040
73849266|NCT05018689|147244186|SUPERIORITY||Mean Difference (Net)|-0.17||||0.006|TWO_SIDED|95.0|-0.29|-0.05|||Regression, Linear|||I would try to stay away from the new student||-0.05|-0.29|0.006
73849267|NCT05018689|147244186|SUPERIORITY||Mean Difference (Net)|-0.02||||0.798|TWO_SIDED|95.0|-0.15|0.11|||Regression, Linear|||The new student would be made fun of at my school||0.11|-0.15|0.798
73961078|NCT02527148|147458038|SUPERIORITY|||||||0.6425|||||||t-test, 2 sided|||To compare IKSS Function preoperatively between both groups.||||0.6425
73961079|NCT02527148|147458038|SUPERIORITY|||||||0.5041|||||||t-test, 2 sided|||To compare IKSS ROM preoperatively between both groups.||||0.5041
73961080|NCT02527148|147458038|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||To compare IKSS Pain at 6-weeks between both groups.||||0.2230
73961081|NCT02527148|147458038|SUPERIORITY|||||||0.8209|||||||t-test, 2 sided|||To compare IKSS Function at 6-weeks between both groups.||||0.8209
73961082|NCT02527148|147458038|SUPERIORITY|||||||0.6958|||||||t-test, 2 sided|||To compare IKSS ROM at 6-weeks between both groups.||||0.6958
73961083|NCT02527148|147458038|SUPERIORITY|||||||0.0548|||||||t-test, 2 sided|||To compare IKSS Pain at 6-months between both groups.||||0.0548
73849268|NCT05018689|147244186|SUPERIORITY||Mean Difference (Net)|-0.09||||0.197|TWO_SIDED|95.0|-0.22|0.05|||Regression, Linear|||The new student would be ignored at my school||0.05|-0.22|0.197
73849269|NCT05018689|147244186|SUPERIORITY||Mean Difference (Net)|0.03||||0.623|TWO_SIDED|95.0|-0.1|0.16|||Regression, Linear|||I think other students in my school would try to help the new student||0.16|-0.10|0.623
73849270|NCT05018689|147244187|SUPERIORITY||Mean Difference (Net)|0.05||||0.718|TWO_SIDED|95.0|-0.21|0.3|||Regression, Linear|||On a scale from 1 to 7, if you were seen going into the office of your school social worker or school psychologist, how would you feel?||0.30|-0.21|0.718
73849271|NCT05018689|147244188|SUPERIORITY||Mean Difference (Net)|0.21||||0.09|TWO_SIDED|95.0|-0.03|0.46|||Regression, Linear|||How comfortable are you talking about mental health issues with other students at your school?||0.46|-0.03|0.090
73849272|NCT05018689|147244189|SUPERIORITY||comparison of odds ratios|0.99||||0.944|TWO_SIDED|95.0|0.67|1.44|||Regression, Logistic|||Depression||1.44|0.67|0.944
73849273|NCT05018689|147244189|SUPERIORITY||comparison of odds ratios|1.18||||0.369|TWO_SIDED|95.0|0.82|1.68|||Regression, Logistic|||Anxiety||1.68|0.82|0.369
73961084|NCT02527148|147458038|SUPERIORITY|||||||0.1958|||||||t-test, 2 sided|||To compare IKSS Function at 6-months between both groups.||||0.1958
73961085|NCT02527148|147458038|SUPERIORITY|||||||0.2786|||||||t-test, 2 sided|||To compare IKSS ROM at 6-months between both groups.||||0.2786
73961086|NCT02527148|147458038|SUPERIORITY|||||||0.2399|||||||t-test, 2 sided|||To compare IKSS Pain at 1-year between both groups.||||0.2399
73849274|NCT05018689|147244189|SUPERIORITY||comparison of odds ratios|1.07||||0.676|TWO_SIDED|95.0|0.77|1.5|||Regression, Logistic|||Thoughts of suicide||1.50|0.77|0.676
73849275|NCT05018689|147244189|SUPERIORITY||comparison of odds ratios|0.79||||0.432|TWO_SIDED|95.0|0.44|1.42|||Regression, Logistic|||I do not think there are any mental health issues that are concerning for students||1.42|0.44|0.432
73849276|NCT05018689|147244189|SUPERIORITY||comparison of odds ratios|0.87||||0.533|TWO_SIDED|95.0|0.56|1.35|||Regression, Logistic|||Other||1.35|0.56|0.533
73849277|NCT05018689|147244190|SUPERIORITY||Mean Difference (Net)|-0.01||||0.769|TWO_SIDED|95.0|-0.11|0.08|||Regression, Linear|||How much do your teachers know about addressing student mental health needs?||0.08|-0.11|0.769
73961087|NCT02527148|147458038|SUPERIORITY|||||||0.4135|||||||t-test, 2 sided|||To compare IKSS Function at 1-year between both groups.||||0.4135
73961088|NCT02527148|147458038|SUPERIORITY|||||||0.5278|||||||t-test, 2 sided|||To compare IKSS ROM at 1-year between both groups.||||0.5278
73961089|NCT02527148|147458038|SUPERIORITY|||||||0.2992|||||||t-test, 2 sided|||To compare IKSS Pain at 2-year between both groups.||||0.2992
73961090|NCT02527148|147458038|SUPERIORITY|||||||0.5462|||||||t-test, 2 sided|||To compare IKSS Function at 2-year between both groups.||||0.5462
73961091|NCT02527148|147458038|SUPERIORITY|||||||0.5765|||||||t-test, 2 sided|||To compare IKSS ROM at 2-year between both groups.||||0.5765
73961092|NCT02527148|147458038|SUPERIORITY|||||||0.5493|||||||t-test, 2 sided|||To compare IKSS Pain at 5-year between both groups.||||0.5493
73961093|NCT02527148|147458038|SUPERIORITY|||||||0.1705|||||||t-test, 2 sided|||To compare IKSS Function at 5-year between both groups.||||0.1705
73961094|NCT02527148|147458038|SUPERIORITY|||||||0.2918|||||||t-test, 2 sided|||To compare IKSS ROM at 5-year between both groups.||||0.2918
73961095|NCT02527148|147458039|OTHER|||||||0.6|||||||t-test, 2 sided|||Comparison of coronal mechanical axis:hip knee ankle angle between both groups.||||0.6
73961096|NCT02527148|147458039|OTHER|||||||0.002|||||||t-test, 2 sided|||Comparison of coronal angle fem comp and mech axis femur between both groups.||||0.002
73961097|NCT02527148|147458039|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of coronal angle tibial comp and mech axis tibia between both groups.||||<0.001
73961098|NCT02527148|147458039|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of sagital tibial component slope between both groups.||||<0.001
73961099|NCT02527148|147458039|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of Fem comp rotation relative to surg epicond axis+=ER between both groups.||||<0.001
73961100|NCT01254019|147458088|SUPERIORITY||Mean Difference (Net)|10.334||||0.415|TWO_SIDED|95.0|-14.645|35.312||Statistical significance was assessed at the 5% level.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||35.312|-14.645|0.415
73961101|NCT01254019|147458089|SUPERIORITY||Mean Difference (Net)|-0.53||||0.757|TWO_SIDED|95.0|-3.95|2.88||Statistical significance (SS) was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||2.88|-3.95|0.757
74023760|NCT01381094|147600239|SUPERIORITY||||||=|0.7705|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7705
73849278|NCT05018689|147244190|SUPERIORITY||Mean Difference (Net)|0.05||||0.315|TWO_SIDED|95.0|-0.05|0.16|||Regression, Linear|||How much do your school counselors know about addressing student mental health needs?||0.16|-0.05|0.315
73849279|NCT05018689|147244191|SUPERIORITY||comparison of odds ratios|0.86||||0.345|TWO_SIDED|95.0|0.63|1.18|||Regression, Logistic|||Mental health information sheets at school||1.18|0.63|0.345
73849280|NCT05018689|147244191|SUPERIORITY||comparison of odds ratios|0.98||||0.899|TWO_SIDED|95.0|0.73|1.33|||Regression, Logistic|||Class activities about mental health||1.33|0.73|0.899
73849281|NCT05018689|147244191|SUPERIORITY||comparison of odds ratios|1.08||||0.612|TWO_SIDED|95.0|0.8|1.48|||Regression, Logistic|||Mental health information on school website||1.48|0.80|0.612
73849282|NCT05018689|147244191|SUPERIORITY||comparison of odds ratios|1.14||||0.476|TWO_SIDED|95.0|0.79|1.65|||Regression, Logistic|||Other||1.65|0.79|0.476
73849283|NCT05018689|147244192|SUPERIORITY||Mean Difference (Net)|-0.09||||0.141|TWO_SIDED|95.0|-0.22|0.03|||Regression, Linear|||On average, how often do your teachers speak to you about your emotions and feelings?||0.03|-0.22|0.141
73849284|NCT05018689|147244193|SUPERIORITY||Mean Difference (Net)|0.04||||0.392|TWO_SIDED|95.0|-0.05|0.13|||Regression, Linear|||Would you like your teachers to speak to you about your emotions and feelings?||0.13|-0.05|0.392
73849285|NCT02655887|147244234|NON_INFERIORITY|PG of 74%, which was set at 10% (non-inferiority margin) below the weighted mean of primary patency (PP2) rate at 12 month at a combination of 55% (PTS) subjects at primary patency rate of 77.1% and 45% (NIVL) subjects at primary patency rate of 93.4%. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%\*99%=84%.|Weighted Z-statistics|88.3||||0.0001|ONE_SIDED|90.0|82.4||||Weighted Z-statistics|||"Hypothesis: H0 :Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is at most as good as that of the PG.~Ha: Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is better than that of PG."|||82.4|0.0001
73849286|NCT02655887|147244235|NON_INFERIORITY|The primary safety endpoint was evaluated against the PG of 89% which was set at 10% (non-inferiority margin) below the literature-derived average freedom from MAE rate at 30 day of 99%. A one-side p-value is derived based on an exact binomial test. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%\*99%=84%.|Exact binomial test|93.5||||0.0322|ONE_SIDED|90.0|89.5||||Exact binomial test|||"Hypothesis: H0: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day at most as large as that of the PG.~Ha: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day is better than that of the PG."|||89.5|0.0322
73849287|NCT02655887|147244236|OTHER|||||||0.001||||||this p value is \< 0.001.|t-test, 2 sided|||"H0: The distribution at the 12-month follow-up remains unimproved compared to baseline.~Ha: The distribution shifts toward lower (less pain) classes."||||0.001
73849288|NCT02655887|147244237|OTHER|||||||0.001||||||p value is \< 0.001|t-test, 2 sided|||||||0.001
73849289|NCT02020590|147244249|OTHER||||||||TWO_SIDED|90.0||||||||"The success of ALLOB® treatment was based on the percentage of responders. A treated patient was considered as responding if, at the end of the study (6 months):~* He/she had not required rescue surgery and~* The GDE score as perceived by the patient had improved by at least 25% or the TUS (tomographic union score) as assessed by CT scan had increased by at least 2 points."|The response rate at Month 6 for the 21 patients in the PP population was 100 % (CI: 86.71 - 100.0%). None of the treated patients required rescue surgery. An improvement of GDE score of at least 25% was reported for 16 (76.2%) patients. An increase in TUS of at least 2 points was reported for 16 (76.2%) patients; all patients met at least one of these two criteria.|||
73849290|NCT03141255|147244262|OTHER|||||||1|||||||Fisher Exact|||||||1
73849291|NCT03141255|147244263|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
73849292|NCT03141255|147244264|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73961102|NCT01254019|147458090|SUPERIORITY||Mean Difference (Net)|-0.021||||0.718|TWO_SIDED|95.0|-0.137|0.095||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.095|-0.137|0.718
73961103|NCT01254019|147458091|SUPERIORITY||Mean Difference (Net)|-0.009||||0.881|TWO_SIDED|95.0|-0.129|0.111||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.111|-0.129|0.881
73961104|NCT01254019|147458092|SUPERIORITY||Mean Difference (Net)|-1.115||||0.658|TWO_SIDED|95.0|-6.097|3.866||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||3.866|-6.097|0.658
73961105|NCT01254019|147458093|SUPERIORITY||Mean Difference (Net)|0.041||||0.513|TWO_SIDED|95.0|-0.082|0.164||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.164|-0.082|0.513
73961106|NCT01254019|147458094|SUPERIORITY||Mean Difference (Net)|-0.965||||0.769|TWO_SIDED|95.0|-7.446|5.516||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||5.516|-7.446|0.769
73961107|NCT01254019|147458097|SUPERIORITY||Mean Difference (Net)|-4044.99||||0|TWO_SIDED|95.0|-5232.21|-2857.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||-2857.77|-5232.21|0.000
73961108|NCT01254019|147458103|SUPERIORITY||Mean Difference (Net)|0.0288||||0.207|TWO_SIDED|95.0|-0.0161|0.0738||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI2 at Week 48||0.0738|-0.0161|0.207
73961109|NCT01254019|147458103|SUPERIORITY||Mean Difference (Net)|0.0048||||0.88|TWO_SIDED|95.0|-0.058|0.0676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI3 at Week 48||0.0676|-0.0580|0.880
73961110|NCT03061474|147458112|SUPERIORITY|||||||0.6096|||||||ANCOVA|||||||0.6096
73961111|NCT03061474|147458122|SUPERIORITY|||||||0.648|||||||ANCOVA|||||||0.648
73961112|NCT03061474|147458123|SUPERIORITY|||||||0.6833|||||||ANCOVA|||||||0.6833
73961113|NCT03061474|147458124|SUPERIORITY|||||||0.4438|||||||ANCOVA|||||||0.4438
73961114|NCT03061474|147458125|SUPERIORITY|||||||0.7158|||||||ANCOVA|||||||0.7158
73961115|NCT03061474|147458126|SUPERIORITY|||||||0.93428359|||||||ANCOVA|||||||0.93428359
74023761|NCT01381094|147600239|SUPERIORITY||||||=|0.0024|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0024
74023762|NCT01381094|147600239|SUPERIORITY||||||=|0.0006|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0006
73961116|NCT03061474|147458127|SUPERIORITY|||||||0.9931|||||||ANCOVA|||||||0.9931
73961117|NCT03061474|147458128|SUPERIORITY|||||||0.3233|||||||Mixed Models Analysis|||||||0.3233
73961118|NCT03061474|147458129|SUPERIORITY|||||||0.1008|||||||Mixed Models Analysis|||||||0.1008
73961119|NCT03061474|147458130|SUPERIORITY|||||||0.0323|||||||Mixed Models Analysis|||||||0.0323
73961120|NCT00189202|147458157|EQUIVALENCE|Equivalence margin 8% plus or minus 4.||||||0.28|||||||Mantel Haenszel|||||||0.28
73961121|NCT00189202|147458158|OTHER|||||||0.7|||||||Kaplan-Meier|||||||0.70
73961122|NCT00666276|147458180|SUPERIORITY_OR_OTHER||||||=|0.712|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the incidence rate of ADRs."||||=0.712
73961123|NCT00666276|147458181|SUPERIORITY_OR_OTHER||||||=|0.257|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between over 65 and less than 65 in the incidence rate of ADRs."||||=0.257
73961124|NCT00666276|147458182|SUPERIORITY_OR_OTHER||||||=|0.082|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic dysfunctions. The null hypothesis is there is no difference between with Hepatic dysfunction and without Hepatic dysfunction in the incidence rate of ADRs."||||=0.082
73961125|NCT00666276|147458183|SUPERIORITY_OR_OTHER||||||=|0.462|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal dysfunctions. The null hypothesis is there is no difference between with Renal dysfunction and without Renal dysfunction in the incidence rate of ADRs."||||=0.462
73849293|NCT03141255|147244265|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73961126|NCT00666276|147458184|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Duration of drug administration. The null hypothesis is there is no difference between over 15 days and less than 15 days in the incidence rate of ADRs."||||<0.001
73961127|NCT00666276|147458185|SUPERIORITY_OR_OTHER||||||=|0.018|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Route of administration. The null hypothesis is there is no difference between oral, injection and switch in the incidence rate of ADRs."||||=0.018
73961128|NCT00666276|147458186|SUPERIORITY_OR_OTHER||||||=|0.311|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Weight. The null hypothesis is there is no difference between over 40kg and less than 40kg in the incidence rate of ADRs."||||=0.311
73961129|NCT00666276|147458187|SUPERIORITY_OR_OTHER||||||=|0.044|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant drugs. The null hypothesis is there is no difference between with Concomitant drug and without Concomitant drug in the incidence rate of ADRs."||||=0.044
73961130|NCT00666276|147458188|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Non-drug therapies. The null hypothesis is there is no difference between with Non-drug therapies and without Non-drug therapies in the incidence rate of ADRs."||||=0.008
73961131|NCT03299816|147458198|SUPERIORITY|||||||0.17||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.17
73961132|NCT03299816|147458199|SUPERIORITY|||||||0.36||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.36
73961133|NCT03299816|147458200|SUPERIORITY|||||||0.33||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.33
73961134|NCT03299816|147458201|SUPERIORITY|||||||0.61||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.61
73961135|NCT03299816|147458202|SUPERIORITY|||||||0.73||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.73
73961136|NCT03299816|147458203|SUPERIORITY|||||||0.75||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.75
73961137|NCT03520413|147458204|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-0.61||||0.02|TWO_SIDED|95.0|-1.12|-0.11|||Mixed Models Analysis|||||-0.11|-1.12|0.02
73961138|NCT03520413|147458205|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-0.25||||0.007|TWO_SIDED|95.0|-0.42|-0.07|||Mixed Models Analysis|||||-0.07|-0.42|0.007
74023763|NCT01381094|147600239|SUPERIORITY||||||=|0.6189|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.6189
74023764|NCT01381094|147600239|SUPERIORITY||||||=|0.0075|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0075
74023765|NCT01381094|147600239|SUPERIORITY||||||=|0.0259|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0259
74023766|NCT01381094|147600239|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
74023767|NCT01381094|147600239|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
74023768|NCT01381094|147600239|SUPERIORITY||||||=|0.8898|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.8898
74023769|NCT01381094|147600239|SUPERIORITY||||||=|0.001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0010
74023770|NCT01381094|147600239|SUPERIORITY||||||=|0.2864|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2864
74023771|NCT01381094|147600239|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
74023772|NCT01381094|147600239|SUPERIORITY||||||=|0.0016|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0016
73849294|NCT03141255|147244266|SUPERIORITY|||||||0.029|||||||Mixed Models Analysis|||||||0.029
74023773|NCT01381094|147600239|SUPERIORITY||||||=|0.9697|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9697
74023774|NCT01381094|147600240|SUPERIORITY||||||=|1|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=1.0000
74023775|NCT01381094|147600240|SUPERIORITY||||||=|0.0055|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0055
74023776|NCT01381094|147600240|SUPERIORITY||||||=|0.0009|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0009
73849295|NCT03141255|147244267|SUPERIORITY|||||||0.091|||||||Mixed Models Analysis|||||||0.091
73849296|NCT03141255|147244268|SUPERIORITY|||||||0.029|||||||Mixed Models Analysis|||||||0.029
73849297|NCT03141255|147244269|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
73849298|NCT03141255|147244270|SUPERIORITY|||||||0.516|||||||Fisher Exact|||||||0.516
73849299|NCT03141255|147244271|OTHER|||||||0.75|||||||Kaplan Meier|||||||0.75
73849300|NCT03141255|147244272|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
73849301|NCT03141255|147244273|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||0.052
73849302|NCT04419467|147244292|SUPERIORITY||GM % treatment difference (80% CI)|-0.5||||0.485|TWO_SIDED|80.0|-14.8|16.3||One-sided p-value|Mixed Models Repeated Measures Analysis||Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean (GM), then expressed as percent treatment difference.|||16.3|-14.8|0.485
73961139|NCT03520413|147458206|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|0.51||||0.0002|TWO_SIDED|95.0|0.25|0.78|||Mixed Models Analysis|||||0.78|0.25|0.0002
74023777|NCT01381094|147600240|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0002
74023778|NCT01381094|147600240|SUPERIORITY||||||=|0.9722|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.9722
73961140|NCT03520413|147458207|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|0.39||||0.02|TWO_SIDED|95.0|0.07|0.71|||Mixed Models Analysis|||||0.71|0.07|0.02
73961141|NCT03520413|147458208|EQUIVALENCE|Difference between groups at 6months|Mean Difference (Final Values)|0.19||||0.39|TWO_SIDED|95.0|-0.24|0.62|||Mixed Models Analysis|||||0.62|-0.24|0.39
74084725|NCT03653026|147722718|SUPERIORITY||Adjusted Response Rate Difference|27.1|||<|0.001|TWO_SIDED|95.0|19.0|35.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (\<= 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||35.3|19.0|<0.001
73849303|NCT04419467|147244292|SUPERIORITY||GM % treatment difference (80% CI)|8.6||||0.75|TWO_SIDED|80.0|-7.2|27.2||One-sided p-value|Mixed Models Repeated Measures Analysis||Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean, then expressed as percent treatment difference|||27.2|-7.2|0.750
73849304|NCT01925768|147244309|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.7||||0.004|TWO_SIDED|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||29.3|6.2|0.0040
73849305|NCT01925768|147244310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.103||||0.1677|TWO_SIDED|95.0|-0.251|0.044|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||0.044|-0.251|0.1677
73849306|NCT01925768|147244311|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.5||||0.004|TWO_SIDED|95.0|6.3|30.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel|Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.|Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||30.6|6.3|0.0040
73849307|NCT01925768|147244312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.0051|TWO_SIDED|95.0|-0.85|-0.15|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate.|||-0.15|-0.85|0.0051
73849308|NCT01925768|147244313|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.68||||0.0167|TWO_SIDED|95.0|0.49|4.88|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||4.88|0.49|0.0167
73849309|NCT01925768|147244314|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.4||||0.0039|TWO_SIDED|95.0|1.1|5.7||Based on an MMRM model for the change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD use and baseline Oral Corticosteroids use as factors and the baseline value as a covariate.|Mixed Models Analysis|||2-sided 95% CI for the difference in LS mean.||5.70|1.10|0.0039
73849310|NCT01925768|147244315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0||||0.012|TWO_SIDED|95.0|-21.5|10.2|||Sign test|p-value based on distribution free signed rank test||||10.2|-21.5|0.012
73849311|NCT01925768|147244316|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.7||||0.0016|TWO_SIDED|95.0|8.0|31.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline oral corticosteroids (prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||31.3|8.0|0.0016
73849312|NCT01925768|147244317|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15||||0.0229|TWO_SIDED|95.0|-0.279|-0.021|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||-0.021|-0.279|0.0229
73849313|NCT01925768|147244318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.35|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||-0.35|-1.00|<0.0001
73849314|NCT01925768|147244319|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.46||||0.0039|TWO_SIDED|95.0|1.13|5.8|||Mixed Models Analysis||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|||5.80|1.13|0.0039
73849315|NCT01925768|147244320|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann|10.0||||0.0168|TWO_SIDED|95.0|0.0|20.0|||Stratified Van Elteren test|p-value based on stratified Van Elteren test, using 2 stratification factors: previous DMARD use and baseline Oral Corticosteroids|Location shift and 95% CI based on Hodges-Lehmann for between treatment median estimates.|||20.0|0.0|0.0168
73961142|NCT03520413|147458209|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-1.16||||0.1|TWO_SIDED|95.0|-2.53|0.21|||Mixed Models Analysis|||||0.21|-2.53|0.10
74023779|NCT01381094|147600240|SUPERIORITY||||||=|1|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=1.0000
73849316|NCT01925768|147244321|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|20.7||||0.0015|TWO_SIDED|95.0|8.5|32.8||2 sided-p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|||32.8|8.5|0.0015
73849317|NCT01925768|147244322|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.7||||0.0252|TWO_SIDED|95.0|1.6|17.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 2; 2-sided 95% CI is based on a normal approximation to the weighted average||17.7|1.6|0.0252
74023780|NCT01381094|147600240|SUPERIORITY||||||=|0.0008|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0008
73849318|NCT01925768|147244322|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.6||||0.1121|TWO_SIDED|95.0|-1.7|18.9||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 4; 2-sided 95% CI is based on a normal approximation to the weighted average||18.9|-1.7|0.1121
73849319|NCT01925768|147244322|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.8||||0.0036|TWO_SIDED|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 6; 2-sided 95% CI is based on a normal approximation to the weighted average||29.3|6.2|0.0036
73849320|NCT01925768|147244322|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.7||||0.0392|TWO_SIDED|95.0|0.8|24.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 8; 2-sided 95% CI is based on a normal approximation to the weighted average||24.6|0.8|0.0392
73849321|NCT01925768|147244322|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.0||||0.0884|TWO_SIDED|95.0|-1.3|23.2||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 12; 2-sided 95% CI is based on a normal approximation to the weighted average||23.2|-1.3|0.0884
73849322|NCT01925768|147244322|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.6||||0.004|TWO_SIDED|95.0|6.5|30.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 20; 2-sided 95% CI is based on a normal approximation to the weighted average||30.7|6.5|0.0040
73849323|NCT04571060|147244339|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.8|||<|0.0001|TWO_SIDED|95.0|4.5|13.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||13.1|4.5|<0.0001
73849324|NCT04571060|147244340|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.7||||0.0012|TWO_SIDED|95.0|3.4|13.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||13.9|3.4|0.0012
73849325|NCT04571060|147244341|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|9.0||||0.0012|TWO_SIDED|95.0|3.6|14.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.5|3.6|0.0012
73849326|NCT04571060|147244342|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|10.2||||0.0001|TWO_SIDED|95.0|5.0|15.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||15.5|5.0|0.0001
73849327|NCT04571060|147244343|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|7.6||||0.0048|TWO_SIDED|95.0|2.3|12.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||12.9|2.3|0.0048
73961143|NCT02311907|147458210|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Generalized linear models (repeated measures analysis of variance \[ANOVA\]) will be used to compare the CIPN between GSH and placebo arms.||||0.21
73961144|NCT02311907|147458211|SUPERIORITY_OR_OTHER|||||||0.63|||||||Log Rank|||||||0.63
73961145|NCT00891930|147458277|SUPERIORITY|||||||0.013|||||||Regression, Cox|||||||0.0130
74023781|NCT01381094|147600240|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0002
73961146|NCT01444417|147458324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0497||||0.0018|TWO_SIDED|95.0|1.896|43.199|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of durable platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.||43.199|1.896|0.0018
74084726|NCT03653026|147722719|SUPERIORITY||Adjusted Response Rate Difference|29.1|||<|0.001|TWO_SIDED|95.0|20.9|37.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||37.4|20.9|<0.001
73849328|NCT04571060|147244344|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|6.5||||0.013|TWO_SIDED|95.0|1.4|11.7||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.7|1.4|0.0130
73849329|NCT04571060|147244345|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.9||||0.0076|TWO_SIDED|95.0|1.3|8.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||8.5|1.3|0.0076
73849330|NCT04571060|147244346|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|3.7||||0.0308|TWO_SIDED|95.0|0.3|7.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||7.1|0.3|0.0308
73849331|NCT04571060|147244347|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.3||||0.0123|TWO_SIDED|95.0|1.8|14.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.9|1.8|0.0123
73961147|NCT01444417|147458325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0443||||0.0002|TWO_SIDED|95.0|2.535|32.265|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of overall platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.||32.265|2.535|0.0002
73961148|NCT01444417|147458326|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|P-value from Analysis of Variance with main effects (treatment and age group) model after testing for non-significant interaction (p-value ≥ 0.10).||||||0.0004
73961149|NCT01444417|147458327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.813||||0.7103|TWO_SIDED|95.0|0.277|2.391|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group||||2.391|0.277|0.7103
73961150|NCT02755116|147458330|SUPERIORITY||Adjusted relative risk|0.76||||0.003|TWO_SIDED|95.0|0.48|1.2|||log-binomial regression|||||1.20|0.48|0.003
73849332|NCT04571060|147244348|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.6||||0.0018|TWO_SIDED|95.0|3.2|14.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.1|3.2|0.0018
73849333|NCT04571060|147244349|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|6.0||||0.0293|TWO_SIDED|95.0|0.6|11.4||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.4|0.6|0.0293
73849334|NCT04571060|147244350|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.7||||0.0362|TWO_SIDED|95.0|0.3|9.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||9.1|0.3|0.0362
73849335|NCT04571060|147244351|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|10.2|||<|0.0001|TWO_SIDED|95.0|5.5|15.0||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||15.0|5.5|<0.0001
73849336|NCT04571060|147244352|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.4||||0.0059|TWO_SIDED|95.0|1.3|7.6||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||7.6|1.3|0.0059
73849337|NCT04571060|147244353|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|7.8|||<|0.0001|TWO_SIDED|95.0|4.2|11.3||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.3|4.2|<0.0001
73849338|NCT04970069|147244396|SUPERIORITY||Ratio of geometric means|1.01||||0.89|TWO_SIDED|95.0|0.86|1.18|||Regression, Linear||The numerator and denominator for the ratio of geometric means are analgesic education and general preoperative education respectively.|Multiple imputation by chained equations (MICE) was used for imputing missing outcomes and covariates.||1.18|0.86|0.890
73849339|NCT04970069|147244397|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.617|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.617
73849340|NCT04970069|147244398|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.611|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.611
73849341|NCT00142792|147244399|SUPERIORITY_OR_OTHER|||||||0.18||||||Time by group interaction effect, F(2,372) = 1.8, p =0.18)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||The study was powered to detect differences in FMA scores of a minimum effect size of 0.8 at a significance level of 0.01, the smallest effect size difference anticipated between Cyclic NMES and Cyclic Sensory Stimulation based on prior studies. A significance level of 0.01 in the power-analysis was taken since for each measurement occasion, three post-hoc tests are needed. To account for drop out of 20 % , the minimum number of participants required per group is 63.||||0.18
73849342|NCT00142792|147244399|SUPERIORITY||||||<|0.001||||||time effect, F(1,109)=87.7, p\<0.001)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||<0.001
73961151|NCT01063972|147458339|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
73961152|NCT01063972|147458340|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
73961153|NCT01063972|147458341|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
74023782|NCT01381094|147600240|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
74023783|NCT01381094|147600240|SUPERIORITY||||||=|0.6579|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6579
74023784|NCT01381094|147600240|SUPERIORITY||||||=|0.4102|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.4102
74023785|NCT01381094|147600240|SUPERIORITY||||||=|0.0023|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0023
74023786|NCT01381094|147600240|SUPERIORITY||||||=|0.0052|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0052
73849343|NCT00142792|147244400|SUPERIORITY_OR_OTHER|||||||0.27||||||time by group interaction effect, F(2,373) = 1.3, p =0.27|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||0.27
73849344|NCT00142792|147244400|SUPERIORITY||||||<|0.001||||||time effect, F(1,109)=91.1, p\<0.001|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||<0.001
73849345|NCT01328743|147244401|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||.04
73961154|NCT01063972|147458342|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.48
73961155|NCT03475316|147458347|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.14|1.49|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the composite score pre and post intervention.||1.49|-1.14|
74023787|NCT01381094|147600240|SUPERIORITY||||||=|0.0017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0017
74023788|NCT01381094|147600240|SUPERIORITY||||||=|0.7378|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7378
73849346|NCT01328743|147244402|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
73849347|NCT01328743|147244403|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
73849348|NCT01328743|147244404|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||.48
73849349|NCT01328743|147244405|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||.25
73849350|NCT01328743|147244406|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
73849351|NCT02481258|147244407|EQUIVALENCE|Power calculations were based on a two-sample t-test. A priori calculations to detect an effect size of 0.57 units indicated that that 50 patients per arm were needed to have 80% power. The actual effect size observed in the present study was 0.86.||||||0.05|||||||ANCOVA|||The statistical analysis was done using an ANCOVA analysis adjusting for the baseline aortic valve calcium levels.||||0.05
73849352|NCT02481258|147244409|EQUIVALENCE|Power calculations were based on a two-sample t-tests assuming initial recruitment of 50 subjects.|||||>|0.05||||||Our a priori threshold for statistical significance was p \< 0.05.|ANCOVA|||||||>0.05
73849353|NCT02481258|147244410|EQUIVALENCE|Power calculations were based on a two-sample t-test.|||||>|0.05||||||Our a priori threshold for statistical significance was p \< 0.05.|ANCOVA|||The statistical analysis was done using an ANCOVA analysis adjusting for the baseline aortic valve calcium levels.||||>0.05
73849354|NCT01415583|147244437|NON_INFERIORITY|Consistent with the noninferiority design, the null hypothesis states that the bleeding rate in patients receiving perioperative dexamethasone differed from the bleeding rate in patients receiving perioperative placebo; the alternative hypothesis states that the bleeding rate with dexamethasone is not greater than placebo by more than the noninferiority margin.||||||0.05|||||||t-test, 1 sided|||||||0.05
73849355|NCT01415583|147244437|NON_INFERIORITY|This noninferiority margin was set at 5%, meaning a difference in bleeding rates that did not exceed 5% would be taken as evidence that the bleeding with dexamethasone is not greater than that with placebo by more than 5%.||||||0.05|||||||t-test, 1 sided|||||||0.05
73849356|NCT00756275|147244443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33|||<|0.05|TWO_SIDED|95.0|0.91|20.56|||Chi-squared|||||20.56|.91|<0.05
74023789|NCT01381094|147600240|SUPERIORITY||||||=|0.3371|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3371
73961156|NCT03475316|147458348|SUPERIORITY||Mean Difference (Net)|166.16|STANDARD_ERROR_OF_MEAN|-202.7|||TWO_SIDED|95.0|-231.12|563.44|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) are from linear mixed effect models used to examine the difference in change in functional activation/deactivation covariance patterns during the Digit Symbol Substitution test at post intervention from pre intervention between the social dancing and treadmill walking group.||563.44|-231.12|
73849357|NCT00756275|147244444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|2.36||0.5|TWO_SIDED|95.0|-6.29|3.11|||t-test, 2 sided|||||3.11|-6.29|.50
73849358|NCT00756275|147244445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.3|TWO_SIDED|95.0|0.58|14.5|||Fisher Exact|||||14.50|.58|.30
73849359|NCT00756275|147244446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.98|STANDARD_ERROR_OF_MEAN|8.38||0.34|TWO_SIDED|95.0|-24.64|8.68|||t-test, 2 sided|||||8.68|-24.64|.34
73849360|NCT00756275|147244447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.39|STANDARD_ERROR_OF_MEAN|8.1||0.36|TWO_SIDED|95.0|-8.73|23.52|||t-test, 2 sided|||||23.52|-8.73|.36
73849361|NCT00756275|147244448|SUPERIORITY_OR_OTHER|||||||0.57|||||||Chi-squared|||||||.57
73849362|NCT00756275|147244449|SUPERIORITY_OR_OTHER|||||||0.31|||||||Chi-squared|||||||.31
73849363|NCT00756275|147244450|SUPERIORITY_OR_OTHER|||||||0.72|||||||Chi-squared|||||||.72
73849364|NCT00756275|147244451|SUPERIORITY_OR_OTHER|||||||0.18|||||||Chi-squared|||||||.18
73849365|NCT00756275|147244452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.72||0.75|TWO_SIDED|95.0|-3.98|2.87|||t-test, 2 sided|||||2.87|-3.98|.75
73849366|NCT00913510|147244493|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.0||||1||||||The p-value is calculated to the fourth decimal place.|Wilcoxon (Mann-Whitney)|||"H0 : µt = µc versus H1 : µt ≠ µc µt = Exp. relative change of frequency of micturitions per day in test group µc = Exp. relative change of frequency of micturitions per day in control group.~Plan was to have 44 evaluable subjects (90% power) but power of the study was reduced by early termination. It cannot be concluded that there is no difference between the treatment groups due to insufficient power."||||1.0000
73849367|NCT04512001|147244554|EQUIVALENCE|Margins for results to be considered equivalent: -0.6 to 0.5.|Least squares means difference|0.01|||||TWO_SIDED|90.0|-0.16|0.18||||||||0.18|-0.16|
73849368|NCT04512001|147244556|EQUIVALENCE|Margins for results to be considered equivalent: -15%, 15%.|Difference in % Response Rate|-3.94|||||TWO_SIDED|95.0|-9.97|2.11||||||||2.11|-9.97|
73849369|NCT04232943|147244578|OTHER|This study was designed to provide at least 96% power to detect ≥ 60% reduction in shedding rate in the IPV+ dmLT group assuming the shedding rate in the IPV alone group is at least 80%.|Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|0.56|2.464|||||RR = Ratio of proportions: (IPV+dmLT) / IPV|Analysis of Shedding of Poliovirus Type 1||2.464|0.560|
73849370|NCT04232943|147244578|OTHER|This study was designed to provide at least 96% power to detect ≥ 60% reduction in shedding rate in the IPV+ dmLT group assuming the shedding rate in the IPV alone group is at least 80%.|Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.606|1.51|||||RR = Ratio of proportions: (IPV+dmLT) / IPV|Analysis of Shedding of Poliovirus Type 3||1.510|0.606|
73849371|NCT01718522|147244592|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
73849372|NCT01718522|147244593|OTHER|||||||0.12|||||||Wilcoxon Signed-Rank Test|||||||0.12
73849373|NCT01718522|147244594|OTHER|||||||0.3|||||||Wilcoxon Signed-Rank Test|||||||0.30
73849374|NCT01718522|147244595|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
73849375|NCT01718522|147244596|OTHER|||||||0.04|||||||Wilcoxon Signed-Rank Test|||||||0.04
73849376|NCT01718522|147244597|OTHER|||||||0.35|||||||Wilcoxon Signed-Rank Test|||||||0.35
73849377|NCT01718522|147244598|OTHER|||||||0.001|||||||Wilcoxon Signed-Rank Test|||||||0.001
73849378|NCT01718522|147244599|OTHER|||||||0.61|||||||Wilcoxon Signed-Rank Test|||||||0.61
73849379|NCT01718522|147244600|OTHER|||||||0.1|||||||Wilcoxon Signed-Rank Test|||||||0.1
73849380|NCT01718522|147244601|OTHER|||||||0.22|||||||Wilcoxon Signed-Rank Test|||||||0.22
73849381|NCT01000506|147244612|SUPERIORITY_OR_OTHER||Rate Ratio|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.69||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.69|0.39|<0.001
73849382|NCT01000506|147244612|SUPERIORITY_OR_OTHER||Rate Ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.46|0.81||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 250 mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.81|0.46|<0.001
73849383|NCT01000506|147244612|SUPERIORITY_OR_OTHER||Rate Ratio|0.48|||<|0.001|TWO_SIDED|95.0|0.36|0.64||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 750 mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.64|0.36|<0.001
73849384|NCT02379052|147244621|SUPERIORITY||Least Squares (LS) Mean Difference|-1.7||||0.0304|TWO_SIDED|95.0|-3.22|-0.16|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-0.16|-3.22|0.0304
73849385|NCT02379052|147244622|SUPERIORITY||Least Squares Mean Difference|-26.45||||0.0312|TWO_SIDED|95.0|-50.523|-2.387|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-2.387|-50.523|0.0312
73849386|NCT02379052|147244623|SUPERIORITY||Least Squares Mean Difference|-0.8||||0.383|TWO_SIDED|95.0|-2.48|0.96|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||0.96|-2.48|0.3830
73849387|NCT02379052|147244624|SUPERIORITY||Least Squares Mean Difference|-11.0||||0.4147|TWO_SIDED|95.0|-37.46|15.467|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||15.467|-37.460|0.4147
73849388|NCT02379052|147244625|SUPERIORITY||Percent Difference|26.6||||0.049|TWO_SIDED|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method|||51.05|-3.04|0.0490
73849389|NCT02379052|147244626|SUPERIORITY||Percent Difference|26.6||||0.049|TWO_SIDED|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method|||51.05|-3.04|0.0490
73849390|NCT02379052|147244627|SUPERIORITY||Least Squares Mean Difference|-23.23||||0.085|TWO_SIDED|95.0|-49.677|3.212|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||3.212|-49.677|0.0850
73849391|NCT02379052|147244628|SUPERIORITY||Least Squares Mean Difference|-13.9||||0.0635|TWO_SIDED|95.0|-28.54|0.78|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||0.78|-28.54|0.0635
73849392|NCT02379052|147244629|SUPERIORITY||Least Squares Mean Difference|-33.65||||0.0608|TWO_SIDED|95.0|-68.828|1.536|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||1.536|-68.828|0.0608
73849393|NCT02379052|147244630|SUPERIORITY||Least Squares Mean Difference|-21.1||||0.0318|TWO_SIDED|95.0|-40.42|-1.86|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-1.86|-40.42|0.0318
73849394|NCT02379052|147244631|SUPERIORITY||Percent Difference|17.8||||0.1365|TWO_SIDED|95.0|-11.54|43.55||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo|||43.55|-11.54|0.1365
73849395|NCT02379052|147244632|SUPERIORITY||Percent Difference|35.0||||0.0044|TWO_SIDED|95.0|5.69|58.34||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo|||58.34|5.69|0.0044
73849396|NCT02379052|147244633|SUPERIORITY||Least Squares Mean Difference|-107.13|||<|0.0001|TWO_SIDED|95.0|-141.215|-73.046|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-73.046|-141.215|<0.0001
73849397|NCT02379052|147244634|SUPERIORITY||Least Square Mean Difference|-1.6||||0.0006|TWO_SIDED|95.0|-2.5|-0.68|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-0.68|-2.50|0.0006
73849398|NCT02379052|147244635|SUPERIORITY||Least Squares Mean Difference|0.33||||0.091|TWO_SIDED|95.0|-0.053|0.72|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||0.720|-0.053|0.0910
73849399|NCT00532844|147244638|SUPERIORITY||Geometric Mean Ratio|1.5|||<|0.001|TWO_SIDED|95.0|1.2|1.8||The model will constitute the independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable plasma BH4 concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in higher plasma BH4 concentrations when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the plasma BH4 concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.8|1.2|<0.001
73849400|NCT00532844|147244639|SUPERIORITY||Geometric Mean Ratio|0.9||||0.139|TWO_SIDED|95.0|0.7|1.0||The model will constitute the independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable plasma BH2 concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in higher plasma BH2 when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the plasma BH2 concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.0|0.7|0.139
73849401|NCT00532844|147244639|SUPERIORITY||Geometric Mean Ratio|0.96||||0.57|TWO_SIDED|95.0|0.83|1.11||The model will constitute independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable Total B concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in Total B (biopterin) when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the Total B (biopterin) concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.11|0.83|0.570
73849402|NCT00532844|147244642|SUPERIORITY|||||||0.593|||||||ANCOVA|The model will have the treatments and the baseline measurement as independent variables and measurement at Day 13 as the dependent variable.||The raw value of PAT obtained from the first period (baseline to Day 13) will be used to compare the two treatments.||||0.593
73849403|NCT01361217|147244705|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73849404|NCT01361217|147244705|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73849405|NCT01361217|147244706|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73849406|NCT00003869|147244729|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Log Rank|||||||0.54
73849407|NCT00003869|147244730|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
73849408|NCT00003869|147244731|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Log Rank|||||||0.50
73849409|NCT00003869|147244732|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Fisher Exact|||||||0.04
73849410|NCT00003869|147244733|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
73849411|NCT03542266|147244749|OTHER||Proportion (percent)|75.0|||||TWO_SIDED|95.0|46.5|90.3|||||Exact (Clopper-Pearson) 95% confidence interval for complete response rate.|||90.3|46.5|
73849412|NCT00707993|147244822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|||||ONE_SIDED|97.5||0.13|||ANCOVA|Treatment, randomization schedule, and geographic region as class effects; baseline value for the endpoint as a continuous covariate.||Primary null hypothesis: the average Week 52 HbA1c change from Baseline for alogliptin is inferior to that for glipizide (1-sided 97.5% CI \[alpha=0.025\] compared to non-inferiority margin of 0.4%). If the primary null hypothesis was rejected (non-inferiority demonstrated), an additional comparison for statistical superiority of alogliptin was performed. The CI was re-evaluated; statistical superiority declared if the upper limit was \< 0%.||0.13||
73849413|NCT04050384|147244890|OTHER||||||<|0.001|||||||ANCOVA|These analyses apply to the Frontal, Central, and Central-Parietal regions.||||||<0.001
73849414|NCT04050384|147244891|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
73849415|NCT00552071|147244903|OTHER|||||||0.4||||||A two-sided p value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.40
73849416|NCT00552071|147244904|OTHER|||||||0.43||||||A two-sided p value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.43
73849417|NCT01979614|147244905|SUPERIORITY_OR_OTHER||Standard Error|-0.1116||||0.438|TWO_SIDED|95.0|-0.399|0.176|||ANCOVA|||SAP for Global Myocardial Perfusion Reserve Index (MPRI)||0.176|-0.399|0.438
73849418|NCT04723355|147244931|NON_INFERIORITY|In the sample size calculations, we assumed that the innovative 3-lead wireless water resistant Holter System would have a concordance in the diagnosis of arrhythmia compared to the conventional Holter device similar to a previous study that compared a patch to the conventional Holter device. With this assumption, a total sample of 182 participants would have 80% power to demonstrate an accuracy of at least 85% with a significance level of 2.5% (the 95% CI lower limit should be above 85%).|Accuracy|0.87|||||TWO_SIDED|95.0|0.81|0.92||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.92|0.81|
73849419|NCT04723355|147244931|OTHER||Sensitivity|0.9|||||TWO_SIDED|95.0|0.83|0.95||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.95|0.83|
73849420|NCT04723355|147244931|OTHER||Specificity|0.83|||||TWO_SIDED|95.0|0.72|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.72|
73849421|NCT04723355|147244931|OTHER||Positive predictive value|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
74023790|NCT01381094|147600240|SUPERIORITY||||||=|0.0916|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0916
74023791|NCT01381094|147600240|SUPERIORITY||||||=|0.4656|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4656
73849422|NCT04723355|147244931|OTHER||Negative predictive value|0.86|||||TWO_SIDED|95.0|0.76|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.76|
73849423|NCT04723355|147244931|OTHER||Cohen Kappa coefficient|0.74|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
73849424|NCT04723355|147244931|OTHER||Positive likelihood ratio|5.21|||||TWO_SIDED|95.0|3.17|8.58||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||8.58|3.17|
73849425|NCT04723355|147244931|OTHER||Negative likelihood ratio|0.12|||||TWO_SIDED|95.0|0.06|0.21||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.21|0.06|
73849426|NCT04723355|147244932|OTHER||Accuracy|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||1.00|0.97|
73849427|NCT04723355|147244932|OTHER||Sensitivity|1.0|||||TWO_SIDED|95.0|0.85|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.85|
73849428|NCT04723355|147244932|OTHER||Specificity|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.97|
73849429|NCT04723355|147244932|OTHER||Positive predictive value|0.96|||||TWO_SIDED|95.0|0.78|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.78|
73849430|NCT04723355|147244932|OTHER||Negative predictive value|1.0|||||TWO_SIDED|95.0|0.98|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.98|
73849431|NCT04723355|147244932|OTHER||Cohen Kappa coefficient|0.97|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
73849432|NCT04723355|147244932|OTHER||Positive likelihood ratio|157.0|||||TWO_SIDED|95.0|22.25|1107.61||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||1107.61|22.25|
73849433|NCT04723355|147244932|OTHER||Negative likelihood ratio|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0|0|
73849434|NCT04723355|147244933|OTHER||Accuracy|0.85|||||TWO_SIDED|95.0|0.79|0.9||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.90|0.79|
73849435|NCT04723355|147244933|OTHER||Sensitivity|0.82|||||TWO_SIDED|95.0|0.71|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.71|
73961157|NCT03475316|147458348|SUPERIORITY||Mean Difference (Net)|24.6|STANDARD_ERROR_OF_MEAN|28.47|||TWO_SIDED|95.0|-31.2|80.4|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) and p-values are from linear mixed effect models used to examine the difference in change in functional activation/deactivation covariance patterns during the Flanker interference test at post intervention from pre intervention between the social dancing and treadmill walking group.||80.40|-31.20|
74023792|NCT01381094|147600240|SUPERIORITY||||||=|0.1629|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.1629
73849436|NCT04723355|147244933|OTHER||Specificity|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
73849437|NCT04723355|147244933|OTHER||Positive predictive value|0.82|||||TWO_SIDED|95.0|0.71|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.71|
73849438|NCT04723355|147244933|OTHER||Negative predictive value|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
73849439|NCT04723355|147244933|OTHER||Cohen Kappa coefficient|0.7|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
73849440|NCT04723355|147244933|OTHER||Positive likelihood ratio|6.79|||||TWO_SIDED|95.0|4.03|11.43||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||11.43|4.03|
73849441|NCT04723355|147244933|OTHER||Negative likelihood ratio|0.21|||||TWO_SIDED|95.0|0.13|0.34||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.34|0.13|
73849442|NCT04723355|147244934|OTHER||Accuracy|0.93|||||TWO_SIDED|95.0|0.88|0.96||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.96|0.88|
73849443|NCT04723355|147244934|OTHER||Sensitivity|0.78|||||TWO_SIDED|95.0|0.56|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.56|
73849444|NCT04723355|147244934|OTHER||Specificity|0.95|||||TWO_SIDED|95.0|0.9|0.98||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.98|0.90|
73849445|NCT04723355|147244934|OTHER||Positive predictive value|0.69|||||TWO_SIDED|95.0|0.48|0.86||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.86|0.48|
73849446|NCT04723355|147244934|OTHER||Negative predictive value|0.97|||||TWO_SIDED|95.0|0.93|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.93|
73849447|NCT04723355|147244934|OTHER||Cohen Kappa coefficient|0.69|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
73849448|NCT04723355|147244934|OTHER||Positive likelihood ratio|15.26|||||TWO_SIDED|95.0|7.51|30.99||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||30.99|7.51|
73849449|NCT04723355|147244934|OTHER||Negative likelihood ratio|0.23|||||TWO_SIDED|95.0|0.11|0.5||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.50|0.11|
73849450|NCT04723355|147244935|OTHER||Accuracy|0.93|||||TWO_SIDED|95.0|0.89|0.96||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.96|0.89|
73961158|NCT03475316|147458348|SUPERIORITY||Mean Difference (Net)|58.22|STANDARD_ERROR_OF_MEAN|51.2|||TWO_SIDED|95.0|-42.14|158.58|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) are from linear mixed effect models used to examine the difference in functional activation/deactivation covariance patterns during the Imagery of Walking-While Talking task at post intervention from pre intervention between the social dancing and treadmill walking group.||158.58|-42.14|
73961159|NCT03475316|147458349|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.1|6.64|||||The Estimation Parameter is the difference in change at post from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the CHAMPS scores pre and post intervention.||6.64|-5.10|
73961160|NCT03475316|147458350|SUPERIORITY||Mean Difference (Final Values)|7.27|STANDARD_ERROR_OF_MEAN|8.57|||TWO_SIDED|95.0|-11.6|26.14|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in gait speed pre and post intervention.||26.14|-11.60|
73961161|NCT03475316|147458351|SUPERIORITY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-13.4|14.55|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in unipedal stance time pre and post intervention.||14.55|-13.40|
73961162|NCT03475316|147458353|SUPERIORITY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-1.3|3.46|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the geriatric depression scale pre and post intervention.||3.46|-1.30|
73961163|NCT00457743|147458374|SUPERIORITY_OR_OTHER||Disease control Rate (percentage)|56.7||||||95.0|37.4|74.5|||||The disease control rate, defined as the percentage of subjects confirmed with CR, PR, and SD \>=10 weeks on study according to RECIST.|||74.5|37.4|
73961164|NCT00457743|147458376|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|13.3||||||95.0|3.8|30.7|||||The subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|||30.7|3.8|
73961165|NCT00457743|147458385|SUPERIORITY_OR_OTHER||CBR rate (percentage)|40.0||||||95.0|22.7|59.4|||||The clinical benefit response (CBR) rate, defined as the percentage of the subjects confirmed with CR, PR, or SD\>=22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|||59.4|22.7|
73961166|NCT00566527|147458388|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Measles Response Rate (Arm 2 - Arm 3)|-0.91|||||TWO_SIDED|95.0|-2.82|0.87||||||Measles difference||0.87|-2.82|
73849451|NCT04723355|147244935|OTHER||Sensitivity|0.58|||||TWO_SIDED|95.0|0.28|0.85||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.85|0.28|
73849452|NCT04723355|147244935|OTHER||Specificity|0.96|||||TWO_SIDED|95.0|0.92|0.98||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.98|0.92|
73849453|NCT04723355|147244935|OTHER||Positive predictive value|0.5|||||TWO_SIDED|95.0|0.23|0.77||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.77|0.23|
73961167|NCT00566527|147458388|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Mumps Response Rate (Arm 2 - Arm 3)|0.03|||||TWO_SIDED|95.0|-1.2|1.32||||||Mumps difference||1.32|-1.20|
73961168|NCT00566527|147458388|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Rubella Response Rate (Arm 2 - Arm 3)|-0.22|||||TWO_SIDED|95.0|-1.55|1.03||||||Rubella difference||1.03|-1.55|
73961169|NCT00566527|147458388|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -10. Values are shown as percentages.|Varicella Response Rate (Arm 2 - Arm 3)|0.0|||||TWO_SIDED|95.0|-1.28|1.1||||||Varicella difference||1.10|-1.28|
73961170|NCT00566527|147458389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Measles Response Rate (Arm 1 - Arm 3)|-3.97|||||TWO_SIDED|95.0|-6.44|-1.87||||||Measles difference||-1.87|-6.44|
73961171|NCT00566527|147458389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Mumps Response Rate (Arm 1 - Arm 3)|-0.35|||||TWO_SIDED|95.0|-1.71|1.01||||||Mumps difference||1.01|-1.71|
73961172|NCT00566527|147458389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Rubella Response Rate (Arm 1 - Arm 3)|-0.15|||||TWO_SIDED|95.0|-1.34|1.09||||||Rubella difference||1.09|-1.34|
73961173|NCT00566527|147458389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -10. Values are shown as percentages.|Varicella Response Rate (Arm 1 - Arm 3)|0.0|||||TWO_SIDED|95.0|-1.83|1.1||||||Varicella difference||1.10|-1.83|
73961174|NCT04532528|147458436|OTHER|No formal hypotheses were tested.||||||0.9701|||||||Chi-squared|||||||0.9701
73961175|NCT04532528|147458437|OTHER|No formal hypotheses were tested.||||||0.7376|||||||Chi-squared|||At 3 months only||||0.7376
73961176|NCT04532528|147458437|OTHER|No formal hypotheses were tested.||||||0.1356|||||||Chi-squared|||At 6 months only||||0.1356
73961177|NCT04532528|147458437|OTHER|No formal hypotheses were tested.||||||0.68|||||||Chi-squared|||At 9 months only||||0.6800
73961178|NCT04532528|147458438|OTHER|No formal hypotheses were tested.||||||0.5777|||||||Chi-squared|||At 3 months only||||0.5777
73961179|NCT04532528|147458438|OTHER|No formal hypotheses were tested.||||||0.3313|||||||Chi-squared|||At 6 months only||||0.3313
73961180|NCT04532528|147458438|OTHER|No formal hypotheses was tested.||||||0.5697|||||||Chi-squared|||At 9 months only||||0.5697
73961181|NCT04532528|147458438|OTHER|No formal hypotheses were tested.||||||0.5135|||||||Chi-squared|||At 12 months only||||0.5135
73961182|NCT04532528|147458439|OTHER|No formal hypotheses were tested.||||||0.8509|||||||Chi-squared|||At 3 months only||||0.8509
73849454|NCT04723355|147244935|OTHER||Negative predictive value|0.97|||||TWO_SIDED|95.0|0.93|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.93|
73849455|NCT04723355|147244935|OTHER||Cohen Kappa coefficient|0.77|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
73849456|NCT04723355|147244935|OTHER||Positive likelihood ratio|13.92|||||TWO_SIDED|95.0|5.84|33.17||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||33.17|5.84|
73849457|NCT04723355|147244935|OTHER||Negative likelihood ratio|0.43|||||TWO_SIDED|95.0|0.22|0.85||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.85|0.22|
73849458|NCT04723355|147244936|OTHER||Accuracy|0.98|||||TWO_SIDED|95.0|0.95|1.0||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||1.00|0.95|
73849459|NCT04723355|147244936|OTHER||Sensitivity|0.75|||||TWO_SIDED|95.0|0.19|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.19|
73849460|NCT04723355|147244936|OTHER||Specificity|0.99|||||TWO_SIDED|95.0|0.96|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.96|
73849461|NCT04723355|147244936|OTHER||Positive predictive value|0.6|||||TWO_SIDED|95.0|0.15|0.95||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.95|0.15|
73849462|NCT04723355|147244936|OTHER||Negative predictive value|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.97|
73961183|NCT04532528|147458439|OTHER|No formal hypotheses were tested.||||||0.3302|||||||Chi-squared|||At 6 months only||||0.3302
73961184|NCT04532528|147458439|OTHER|No formal hypotheses was tested.||||||0.9005|||||||Chi-squared|||At 9 months only||||0.9005
73849463|NCT04723355|147244936|OTHER||Cohen Kappa coefficient|0.66|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
73849464|NCT04723355|147244936|OTHER||Positive likelihood ratio|65.63|||||TWO_SIDED|95.0|14.8|291.07||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||291.07|14.80|
73961185|NCT04532528|147458439|OTHER|No formal hypotheses were tested.||||||0.2789|||||||Chi-squared|||At 12 months only||||0.2789
73961186|NCT04532528|147458440|OTHER|No formal hypotheses were tested.||||||0.667|||||||Wilcoxon (Mann-Whitney)|||At 3 months only||||0.6670
73961187|NCT04532528|147458440|OTHER|||||||0.1285|||||||Wilcoxon (Mann-Whitney)|||At 6 months only||||0.1285
73961188|NCT04532528|147458440|OTHER|No formal hypotheses was tested.||||||0.7151|||||||Wilcoxon (Mann-Whitney)|||At 9 months only||||0.7151
73961189|NCT04532528|147458440|OTHER|No formal hypotheses were tested||||||0.803|||||||Wilcoxon (Mann-Whitney)|||At 12 months only||||0.8030
73849465|NCT04723355|147244936|OTHER||Negative likelihood ratio|0.25|||||TWO_SIDED|95.0|0.05|1.38||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||1.38|0.05|
73849466|NCT04723355|147244937|OTHER||Accuracy|0.98|||||TWO_SIDED|95.0|0.94|0.99||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.99|0.94|
73849467|NCT04723355|147244937|OTHER||Sensitivity|0.64|||||TWO_SIDED|95.0|0.31|0.89||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.89|0.31|
73849468|NCT04723355|147244937|OTHER||Specificity|1.0|||||TWO_SIDED|95.0|0.98|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.98|
73961190|NCT01636687|147458444|SUPERIORITY_OR_OTHER||Risk Difference (RD)|53.3|||<|0.0001|TWO_SIDED|95.0|36.6|67.7|||Fisher Exact|||Response criterion: IGA 0/1||67.7|36.6|<0.0001
73961191|NCT01636687|147458444|SUPERIORITY_OR_OTHER||Risk Difference (RD)|73.3|||<|0.0001|TWO_SIDED|95.0|58.8|83.9|||Fisher Exact|||Response Criterion: IGA 0/1||83.9|58.8|<0.0001
73849469|NCT04723355|147244937|OTHER||Positive predictive value|1.0|||||TWO_SIDED|95.0|0.59|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.59|
73849470|NCT04723355|147244937|OTHER||Negative predictive value|0.98|||||TWO_SIDED|95.0|0.94|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.94|
73849471|NCT04723355|147244937|OTHER||Cohen Kappa coefficient|0.77|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
73849472|NCT04723355|147244937|OTHER|||||||||||||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.|The positive likelihood ratio could not be calculated due to the value of zero in the denominator|||
73849473|NCT04723355|147244937|OTHER||Negative likelihood ratio|0.36|||||TWO_SIDED|95.0|0.17|0.79||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.79|0.17|
73849474|NCT04723355|147244939|OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|95.0|-6.2|4.31||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||4.31|-6.20|
73849475|NCT04723355|147244939|OTHER||Lin´s concordance correlation coeficient|0.97|||||TWO_SIDED|95.0|0.96|0.98||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.98|0.96|
73849476|NCT04723355|147244940|OTHER||Mean Difference (Final Values)|-2.71|||||TWO_SIDED|95.0|-17.09|11.67||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||11.67|-17.09|
73961192|NCT01636687|147458444|SUPERIORITY_OR_OTHER||Risk Difference (RD)|68.4|||<|0.0001|TWO_SIDED|95.0|53.1|79.8|||Fisher Exact|||Response criterion: PASI 75||79.8|53.1|<0.0001
73961193|NCT01636687|147458444|SUPERIORITY_OR_OTHER||Risk Difference (RD)|83.4|||<|0.0001|TWO_SIDED|95.0|70.7|91.7|||Fisher Exact|||Response criterion: PASI 75||91.7|70.7|<0.0001
73849477|NCT04723355|147244940|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.93|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.93|
73849478|NCT04723355|147244941|OTHER||Mean Difference (Final Values)|0.39|||||TWO_SIDED|95.0|-5.43|6.22||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||6.22|-5.43|
73849479|NCT04723355|147244941|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.93|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.93|
73849480|NCT04723355|147244942|OTHER||Mean Difference (Final Values)|-6.37|||||TWO_SIDED|95.0|-1391.46|1378.72||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||1378.72|-1391.46|
73849481|NCT04723355|147244942|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.94|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.94|
73849482|NCT04723355|147244943|OTHER||Mean Difference (Final Values)|11.04|||||TWO_SIDED|95.0|-2089.58|2111.65||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||2111.65|-2089.58|
73849483|NCT04723355|147244943|OTHER||Lin´s concordance correlation coeficient|0.92|||||TWO_SIDED|95.0|0.89|0.94||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.94|0.89|
73849484|NCT04723355|147244944|OTHER||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-5.45|5.2||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||5.20|-5.45|
73849485|NCT04723355|147244944|OTHER||Lin´s concordance correlation coeficient|0.93|||||TWO_SIDED|95.0|0.91|0.94||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.94|0.91|
73849486|NCT04723355|147244945|OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-13.38|12.07||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||12.07|-13.38|
73849487|NCT04723355|147244945|OTHER||Lin´s concordance correlation coeficient|0.987|||||TWO_SIDED|95.0|0.98|0.99||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.99|0.98|
73849488|NCT04723355|147244946|OTHER||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-1.75|1.56||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||1.56|-1.75|
73849489|NCT04723355|147244946|OTHER||Lin´s concordance correlation coeficient|0.9976|||||TWO_SIDED|95.0|0.997|0.998||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.998|0.997|
73849490|NCT04723355|147244947|SUPERIORITY||chi-squared test statistic|23.529|||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
74023793|NCT01381094|147600240|SUPERIORITY||||||=|0.7032|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.7032
73849491|NCT01109108|147244948|OTHER||Risk Ratio (RR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
73849492|NCT01244035|147244986|OTHER||LS Mean difference|1.1||||0.1325|TWO_SIDED|90.0|-0.54|2.74|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||2.74|-0.54|0.1325
73849493|NCT01244035|147244986|OTHER||LS Mean difference|4.16|||<|0.001|TWO_SIDED|90.0|2.53|5.79|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||5.79|2.53|<0.001
73849494|NCT01244035|147244986|OTHER||LS Mean difference|-3.06||||0.0016|TWO_SIDED|90.0|-4.7|-1.42|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-1.42|-4.70|0.0016
73849495|NCT01244035|147244987|OTHER||LS Mean difference|-2.94||||0.0212|TWO_SIDED|90.0|-5.3|-0.57|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-0.57|-5.30|0.0212
73849496|NCT01244035|147244987|OTHER||LS Mean difference|-2.76||||0.0299|TWO_SIDED|90.0|-5.16|-0.36|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-0.36|-5.16|0.0299
73849497|NCT01244035|147244987|OTHER||LS Mean difference|-0.18||||0.4506|TWO_SIDED|90.0|-2.54|2.19|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||2.19|-2.54|0.4506
73849498|NCT00348946|147244988|SUPERIORITY|BOT Visual-motor control||||||0.005|||||||ANCOVA|||||||0.005
73849499|NCT00348946|147244988|SUPERIORITY|||||||0.17|||||||ANCOVA|||BOT upper limb speed||||0.17
73849500|NCT00348946|147244988|SUPERIORITY|||||||0.17|||||||ANCOVA|||BOT strength||||0.17
73849501|NCT00348946|147244988|SUPERIORITY|||||||0.06|||||||ANCOVA|||Hand dynamometer||||0.06
73849502|NCT00348946|147244988|SUPERIORITY|||||||0.87|||||||ANCOVA|||PANESS||||0.87
73849503|NCT00348946|147244989|SUPERIORITY|||||||0.44|||||||ANCOVA|||DAS: General concept ability||||0.44
73849504|NCT00348946|147244989|SUPERIORITY|||||||0.57|||||||ANCOVA|||DAS: Verbal Cluster||||0.57
73849505|NCT00348946|147244989|SUPERIORITY|||||||0.55|||||||ANCOVA|||DAS: Nonverbal Cluster||||0.55
73849506|NCT00348946|147244989|SUPERIORITY|||||||0.65|||||||ANCOVA|||DAS: Spatial Cluster||||0.65
73849507|NCT00348946|147244990|SUPERIORITY|||||||0.23|||||||ANCOVA|||Digit Span backward||||0.23
73849508|NCT00348946|147244990|SUPERIORITY|||||||0.36|||||||ANCOVA|||Phonetic fluency||||0.36
73849509|NCT00348946|147244990|SUPERIORITY|||||||0.37|||||||ANCOVA|||Semantic fluency||||0.37
73849510|NCT00348946|147244990|SUPERIORITY|||||||0.41|||||||ANCOVA|||CPT: omissions||||0.41
73849511|NCT00348946|147244990|SUPERIORITY|||||||0.73|||||||ANCOVA|||CPT: commissions||||0.73
73849512|NCT00348946|147244990|SUPERIORITY|||||||0.4|||||||ANCOVA|||CPT: hit reaction time||||0.40
73849513|NCT00348946|147244990|SUPERIORITY|||||||0.95|||||||ANCOVA|||CPT: variability||||0.95
73849514|NCT00348946|147244990|SUPERIORITY|||||||0.78|||||||ANCOVA|||CPT: preservations||||0.78
73849515|NCT00348946|147244991|SUPERIORITY|||||||0.16|||||||ANCOVA|||CBCL: Behavior total||||0.16
73849516|NCT00348946|147244991|SUPERIORITY|||||||0.1|||||||ANCOVA|||CBCL: Internalizing total||||0.10
73849517|NCT00348946|147244991|SUPERIORITY|||||||0.24|||||||ANCOVA|||CBCL: externalizing total||||0.24
73849518|NCT00348946|147244991|SUPERIORITY|||||||0.5|||||||ANCOVA|||CDI: Total||||0.50
73849519|NCT00348946|147244992|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.15
73849520|NCT03723980|147245005|SUPERIORITY||Mean Difference (Net)|2.96||||0.329|TWO_SIDED|95.0||||"the calculated p value is for time interval of 4 hours~threshold for statistical significance= \<0.05"|ANOVA|For multiple comparisons between groups, post hoc (LSD) was applied||||||0.329
73849521|NCT03723980|147245005|SUPERIORITY||Mean Difference (Net)|-0.92||||0.764|TWO_SIDED|95.0||||"The calculated p value is for time interval of 12 hours~threshold for statistical significance= \<0.05"|ANOVA|||||||0.764
73849522|NCT03723980|147245005|SUPERIORITY||Mean Difference (Net)|-1.57||||0.605|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 2~threshold for statistical significance= \<0.05"|ANOVA|||||||0.605
73849523|NCT03723980|147245005|SUPERIORITY||Mean Difference (Net)|-0.82||||0.786|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 3~threshold for statistical significance= \<0.05"|ANOVA|||||||0.786
73849524|NCT03723980|147245005|SUPERIORITY||Mean Difference (Net)|-0.72||||0.813|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 4~threshold for statistical significance= \<0.05"|ANOVA|||||||0.813
73849525|NCT03723980|147245007|OTHER||Mean Difference (Net)|2.97|STANDARD_ERROR_OF_MEAN|3.0||0.334|TWO_SIDED|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval.~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.334
73849526|NCT03723980|147245007|OTHER||Mean Difference (Net)|2.33|STANDARD_ERROR_OF_MEAN|3.0||0.448|TWO_SIDED|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours.~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.448
73849527|NCT03723980|147245007|OTHER||Mean Difference (Net)|5.88|STANDARD_ERROR_OF_MEAN|3.0||0.056|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.056
73849528|NCT03723980|147245007|OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|3.0||0.76|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.760
73849529|NCT03723980|147245007|OTHER||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|3.0||0.828|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.828
73849530|NCT03723980|147245007|OTHER||Mean Difference (Net)|11.8|STANDARD_ERROR_OF_MEAN|2.9||0|TWO_SIDED|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.000
74023794|NCT01381094|147600240|SUPERIORITY||||||=|0.5194|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5194
73849531|NCT03723980|147245007|OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|2.9||0.605|TWO_SIDED|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.605
73961194|NCT01039688|147458490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.14||0.0014|TWO_SIDED|95.0|-0.73|-0.18||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA|||||-0.18|-0.73|0.0014
73961195|NCT01039688|147458490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.0004|TWO_SIDED|95.0|-0.77|-0.23||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA|||||-0.23|-0.77|0.0004
73849532|NCT03723980|147245007|OTHER||Mean Difference (Net)|5.23|STANDARD_ERROR_OF_MEAN|2.9||0.8|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.80
73849533|NCT03723980|147245007|OTHER||Mean Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|2.9||0.574|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.574
73849534|NCT03723980|147245007|OTHER||Mean Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|2.9||0.796|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.796
73849535|NCT03723980|147245008|OTHER||Mean Difference (Net)|-0.6||||0.412|TWO_SIDED|||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.412
73849536|NCT03723980|147245008|OTHER||Mean Difference (Net)|2.8||||0.94|TWO_SIDED|||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.94
73849537|NCT03723980|147245008|OTHER||Mean Difference (Net)|5.5||||0.035|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 2~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.035
73849538|NCT03723980|147245008|OTHER||Mean Difference (Net)|4.4||||0.023|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 3~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.023
73849539|NCT03723980|147245008|OTHER||Median Difference (Net)|4.3||||0.02|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 4.~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.020
73849540|NCT03723980|147245009|OTHER|||||||0.15||||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.15
73849541|NCT03723980|147245009|OTHER|||||||0.36||||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.36
73961196|NCT01039688|147458491|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.32|||<|0.0001|TWO_SIDED|95.0|6.81|19.82||A stepdown procedure was used to control for multiple comparisons. For comparison of 5 mg to be statistically significant, comparison of 10 mg to MTX in ACR70 and comparison of 5 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation|||||19.82|6.81|<0.0001
73961197|NCT01039688|147458491|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.25|||<|0.0001|TWO_SIDED|95.0|18.51|31.99||A stepdown procedure was used to control for multiple comparisons. For comparison of 10 mg to MTX in ACR70 to be statistically significant, comparison of 10 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation|||||31.99|18.51|<0.0001
73849542|NCT03723980|147245009|OTHER|||||||0.13||||||"The p-value calculated is for pain score difference at day 2~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.13
73849543|NCT03723980|147245009|OTHER|||||||0.55||||||"The p-value calculated is for pain score difference at day 3~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.55
73849544|NCT03723980|147245009|OTHER|||||||0.17||||||"The p-value calculated is for pain score difference at day 4~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.17
73849545|NCT03198767|147245011|SUPERIORITY||Ratio of number of events|0.71||||0.202|TWO_SIDED|80.0|0.5|1.0|||Mixed Models Analysis|||Day 3||1.00|0.50|0.202
73849546|NCT03198767|147245011|SUPERIORITY||Ratio of number of events|0.21|||<|0.001|TWO_SIDED|80.0|0.14|0.32|||Mixed Models Analysis|||Day 3||0.32|0.14|<0.001
73849547|NCT03198767|147245011|SUPERIORITY||Ratio of number of events|0.3|||<|0.001|TWO_SIDED|80.0|0.19|0.46|||Mixed Models Analysis|||Day 3||0.46|0.19|<0.001
73849548|NCT03198767|147245011|SUPERIORITY||Ratio of number of events|0.79||||0.275|TWO_SIDED|80.0|0.6|1.04|||Mixed Models Analysis|||Day 3||1.04|0.60|0.275
73849549|NCT03198767|147245011|SUPERIORITY||Ratio of number of events|0.78||||0.234|TWO_SIDED|80.0|0.59|1.02|||Mixed Models Analysis|||Day 3||1.02|0.59|0.234
73849550|NCT03198767|147245011|SUPERIORITY||Ratio of number of events|0.98||||0.921|TWO_SIDED|80.0|0.73|1.3|||Mixed Models Analysis|||Day 3||1.30|0.73|0.921
73849551|NCT03198767|147245012|SUPERIORITY||Ratio of number of events|0.68||||0.04|TWO_SIDED|80.0|0.54|0.86|||Mixed Models Analysis|||||0.86|0.54|0.040
73849552|NCT03198767|147245012|SUPERIORITY||Ratio of number of events|0.37|||<|0.001|TWO_SIDED|80.0|0.28|0.49|||Mixed Models Analysis|||||0.49|0.28|<0.001
73849553|NCT03198767|147245012|SUPERIORITY||Ratio of number of events|0.54||||0.008|TWO_SIDED|80.0|0.41|0.72|||Mixed Models Analysis|||||0.72|0.41|0.008
73849554|NCT03198767|147245012|SUPERIORITY||Ratio of number of events|0.79||||0.141|TWO_SIDED|80.0|0.65|0.97|||Mixed Models Analysis|||||0.97|0.65|0.141
73849555|NCT03198767|147245012|SUPERIORITY||Ratio of number of events|0.9||||0.51|TWO_SIDED|80.0|0.74|1.1|||Mixed Models Analysis|||||1.10|0.74|0.510
73849556|NCT03198767|147245012|SUPERIORITY||Ratio of number of events|1.14||||0.401|TWO_SIDED|80.0|0.93|1.41|||Mixed Models Analysis|||||1.41|0.93|0.401
73849557|NCT03198767|147245013|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.426|TWO_SIDED|80.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.426
73961198|NCT02384070|147458641|SUPERIORITY_OR_OTHER|||||||1||||||Analysis of the variance was used and Chi-square test for categorical variables. A sample size was calculated for a 95% confidence level and a power of 80%, assuming a 10% difference between groups.|ANOVA|||||||1
73961199|NCT02384070|147458641|SUPERIORITY_OR_OTHER|||||||1||||||The prior threshold for statistical significance was P \< 0.05|ANOVA|||||||1
73849558|NCT03198767|147245013|SUPERIORITY||Median Difference (Final Values)|-1.06||||0.001|TWO_SIDED|80.0|-1.46|-0.67|||Mixed Models Analysis|||||-0.67|-1.46|0.001
73849559|NCT03198767|147245013|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.009|TWO_SIDED|80.0|-1.25|-0.45|||Mixed Models Analysis|||||-0.45|-1.25|0.009
73849560|NCT03198767|147245013|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.135|TWO_SIDED|80.0|-0.68|-0.05|||Mixed Models Analysis|||||-0.05|-0.68|0.135
73849561|NCT03198767|147245013|SUPERIORITY||Median Difference (Final Values)|-0.19||||0.436|TWO_SIDED|80.0|-0.5|0.12|||Mixed Models Analysis|||||0.12|-0.50|0.436
73849562|NCT03198767|147245013|SUPERIORITY||Median Difference (Final Values)|0.18||||0.452|TWO_SIDED|80.0|-0.13|0.49|||Mixed Models Analysis|||||0.49|-0.13|0.452
73849563|NCT00570323|147245016|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
73849564|NCT03896477|147245019|OTHER||GMC Ratio|2.91|||||TWO_SIDED|95.0|2.47|3.44||||||Serotype 1 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||3.44|2.47|
73849565|NCT03896477|147245019|OTHER||GMC Ratio|1.44|||||TWO_SIDED|95.0|1.23|1.69||||||Serotype 1 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.69|1.23|
73849566|NCT03896477|147245019|OTHER||GMC Ratio|1.93|||||TWO_SIDED|95.0|1.66|2.25||||||Serotype 5 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.25|1.66|
73849567|NCT03896477|147245019|OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.88||||||Serotype 5 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.88|0.65|
73849568|NCT03896477|147245019|OTHER||GMC Ratio|16.03|||||TWO_SIDED|95.0|12.84|20.03||||||Serotype 6A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||20.03|12.84|
73849569|NCT03896477|147245019|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.72|1.06||||||Serotype 6A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.06|0.72|
73961200|NCT01755949|147458649|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein||||0.038
73961201|NCT01755949|147458649|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein||||0.98
73961202|NCT01755949|147458649|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||difference between placebo and colchicine levels at day 28||||0.072
73961203|NCT01755949|147458650|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||placebo vs colchicine||||0.08
73849570|NCT03896477|147245019|OTHER||GMC Ratio|2.51|||||TWO_SIDED|95.0|2.14|2.95||||||Serotype 6B geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.95|2.14|
73849571|NCT03896477|147245019|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.68|0.95||||||Serotype 6B geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.95|0.68|
73849572|NCT03896477|147245019|OTHER||GMC Ratio|2.11|||||TWO_SIDED|95.0|1.83|2.44||||||Serotype 7F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.44|1.83|
73849573|NCT03896477|147245019|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.22||||||Serotype 7F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.22|0.91|
73849574|NCT03896477|147245019|OTHER||GMC Ratio|1.41|||||TWO_SIDED|95.0|1.21|1.65||||||Serotype 9V geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.65|1.21|
73849575|NCT03896477|147245019|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.76|1.05||||||Serotype 9V geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.05|0.76|
73849576|NCT03896477|147245019|OTHER||GMC Ratio|1.65|||||TWO_SIDED|95.0|1.29|2.1||||||Serotype 14 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.10|1.29|
73849577|NCT03896477|147245019|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.73|1.12||||||Serotype 14 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.12|0.73|
73849578|NCT03896477|147245019|OTHER||GMC Ratio|3.69|||||TWO_SIDED|95.0|2.91|4.67||||||Serotype 19A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||4.67|2.91|
73849579|NCT03896477|147245019|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.6|0.87||||||Serotype 19A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.87|0.60|
73849580|NCT03896477|147245019|OTHER||GMC Ratio|0.64|||||TWO_SIDED|95.0|0.52|0.79||||||Serotype 19F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.79|0.52|
73849581|NCT03896477|147245019|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.62|0.89||||||Serotype 19F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.89|0.62|
73849582|NCT03896477|147245019|OTHER||GMC Ratio|2.29|||||TWO_SIDED|95.0|1.89|2.76||||||Serotype 23F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.76|1.89|
73849583|NCT03896477|147245019|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Serotype 23F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.22|0.82|
73849584|NCT04229888|147245105|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in DEQ-5 score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.||||||0.02|||||||ANOVA|||||||0.02
73849585|NCT04229888|147245106|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in MG score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M= 1 representing the largest clinically acceptable difference based on historical data.||||||0.07|||||||ANOVA|||||||0.07
73961204|NCT02200770|147458663|SUPERIORITY||Hazard Ratio (HR)|0.272|||<|0.0001|TWO_SIDED|95.0|0.1496|0.4961|||Regression, Cox|||||0.4961|0.1496|<0.0001
73961205|NCT02200770|147458664|SUPERIORITY||Odds Ratio (OR)|0.352||||0.0033|TWO_SIDED|95.0|0.1755|0.7059|||Regression, Logistic|||||0.7059|0.1755|0.0033
73961206|NCT02200770|147458665|SUPERIORITY||Mean Difference (Net)|0.134|STANDARD_ERROR_OF_MEAN|1.096||0.9026|TWO_SIDED|95.0|-2.0254|2.2941|||ANCOVA|||||2.2941|-2.0254|0.9026
73849586|NCT04229888|147245107|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in TBUT, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.||||||0.66|||||||ANOVA|||||||0.66
73849587|NCT01299389|147245127|SUPERIORITY_OR_OTHER||Least squares (LS) means difference|-9.7|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-14.0|-5.4|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an analysis of covariance (ANCOVA) model with treatment and country as factors and baseline PANSS total score as a covariate.||-5.4|-14.0|<0.0001
73849588|NCT01299389|147245130|SUPERIORITY_OR_OTHER||LS Mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|95.0|-4.1|-1.4|||ANCOVA|||Positive symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-1.4|-4.1|<0.0001
73849589|NCT01299389|147245130|SUPERIORITY_OR_OTHER||LS Mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.61||0.0012|TWO_SIDED|95.0|-3.2|-0.8|||ANCOVA|||Negative symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.8|-3.2|0.0012
73849590|NCT01299389|147245130|SUPERIORITY_OR_OTHER||LS Mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-3.4|-1.1|||ANCOVA|||Disorganized thoughts (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-1.1|-3.4|<0.0001
73849591|NCT01299389|147245130|SUPERIORITY_OR_OTHER||LS Mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0023|TWO_SIDED|95.0|-2.3|-0.5|||ANCOVA|||Uncontrolled hostility/excitement (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.5|-2.3|0.0023
73849592|NCT01299389|147245130|SUPERIORITY_OR_OTHER||LS Mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.37||0.0025|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA|||Anxiety/depression (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.4|-1.9|0.0025
73849593|NCT01299389|147245131|SUPERIORITY_OR_OTHER||LS Mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.59||0.0003|TWO_SIDED|95.0|-3.3|-1.0|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-1.0|-3.3|0.0003
73849594|NCT01299389|147245132|SUPERIORITY_OR_OTHER||LS Mean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.1|-1.5|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-1.5|-4.1|<0.0001
73849595|NCT01299389|147245133|SUPERIORITY_OR_OTHER||LS Mean difference|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-6.9|-2.3|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-2.3|-6.9|<0.0001
73849596|NCT00889707|147245140|SUPERIORITY_OR_OTHER|||||||0.04||||||Test of superiority computed using an ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume. Tested for 2-sided 0.05 level of statistical significance.|ANCOVA|ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume.||||||0.040
73961207|NCT02200770|147458666|SUPERIORITY||Rate Ratio|0.566||||0.0034|TWO_SIDED|95.0|0.3866|0.8279|||Negative Binomial Regression|||||0.8279|0.3866|0.0034
73961208|NCT02200770|147458667|SUPERIORITY||Rate Ratio|0.317||||0.0146|TWO_SIDED|95.0|0.1257|0.7972|||Negative Binomial Regression|||||0.7972|0.1257|0.0146
73961209|NCT01214824|147458688|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.014||95.0|||||Wilcoxon signed rank test|||Comparison is HbA1c at 6 months versus Baseline||||0.014
73961210|NCT01214824|147458690|SUPERIORITY_OR_OTHER|||||||0.5304||95.0|||||Paired t-test|||Comparison is masked phase 2 versus masked phase 1||||0.5304
73961211|NCT02214160|147458692|SUPERIORITY|||||||0.0347|||||||Paired T-test|||||||0.0347
73961212|NCT02214160|147458693|SUPERIORITY|||||||0.0343|||||||Wilcoxon Signed Rank Test|||||||0.0343
73961213|NCT02423798|147458709|OTHER||Mean|9.13|||||TWO_SIDED|||||||||||||
73961214|NCT00275392|147458715|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Interaction effect|RM ANOVA|||||||0.026
73961215|NCT00275392|147458715|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||main effect of time|RM ANOVA|||||||<.001
73961216|NCT00275392|147458715|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||main effect of group|RM ANOVA|||||||>.05
73961217|NCT00275392|147458716|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Interaction effect|RM ANOVA|||||||> 0.05
73849597|NCT00889707|147245141|SUPERIORITY_OR_OTHER|||||||0.047||||||ANCOVA model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.|ANCOVA|Model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.||||||0.047
73849598|NCT02185534|147245142|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|104.43|||||TWO_SIDED|90.0|92.27|118.19|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||118.19|92.27|
73849599|NCT02185534|147245142|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|Geometric mean ratio|97.19|||||TWO_SIDED|90.0|81.12|116.45|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25||116.45|81.12|
73849600|NCT02185534|147245143|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|108.06|||||TWO_SIDED|90.0|95.46|122.33|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||122.33|95.46|
73849601|NCT02185534|147245143|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|105.79|||||TWO_SIDED|90.0|95.22|117.53|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|||117.53|95.22|
73849602|NCT02185534|147245144|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|93.94|||||TWO_SIDED|90.0|87.12|101.29|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||101.29|87.12|
73849603|NCT02185534|147245144|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|92.03|||||TWO_SIDED|90.0|84.91|99.75|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|||99.75|84.91|
73849604|NCT02948582|147245145|SUPERIORITY||least squares mean|0.033||||0.1257|TWO_SIDED|95.0|-0.009|0.075|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.075|-0.009|0.1257
73961218|NCT00275392|147458716|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||main effect of time|RM ANOVA|||||||.016
73961219|NCT00275392|147458716|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Main effect of Group|RM ANOVA|||||||>.05
73961220|NCT00468052|147458725|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Null hypothesis is not significantly different from group D and F.|Wilcoxon (Mann-Whitney)|||Sixty subjects were required per group to determine that with Dex would decrease the incidence of severe EA after surgery by 50% with 80% power (0.05)in comparison with the control group.60 subjects were required by group to show the that intraoperative rescue fentanyl and rescue morphine in the PACU would be 50% lower in subjects receiving dex.||||.001
73961221|NCT00468052|147458725|NON_INFERIORITY_OR_EQUIVALENCE|Treatment with Dex would reduce the incidence of severe agitation be 50% with an 80% power (alpha 0.05)||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis dexmedetomidine would be a safe and effective substitute to opiates in reducing pain and the incidence of severe EA||||.001
73961222|NCT00468052|147458726|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.004
73961223|NCT00468052|147458728|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
73961224|NCT00468052|147458729|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||||||0.02
73961225|NCT02928224|147458748|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
73961226|NCT02928224|147458749|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
73961227|NCT02928224|147458750|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73961228|NCT02928224|147458759|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
73961229|NCT02928224|147458760|OTHER|||||||0.5958|||||||Stratified Log-rank|||||||0.5958
73961230|NCT02928224|147458761|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
73961231|NCT02928224|147458762|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
73961232|NCT02928224|147458763|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
73961233|NCT02928224|147458764|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
73961234|NCT02928224|147458765|OTHER|||||||0.1004|||||||Stratified Log-rank|||||||0.1004
73961235|NCT02928224|147458766|OTHER|||||||0.3724|||||||Stratified Log-rank|||||||0.3724
73961236|NCT02928224|147458767|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73961237|NCT02928224|147458768|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73961238|NCT02928224|147458769|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73961239|NCT02928224|147458770|OTHER|||||||0.1928|||||||Cochran-Mantel-Haenszel|||||||0.1928
73961240|NCT02928224|147458771|OTHER|||||||0.0357|||||||Cochran-Mantel-Haenszel|||||||0.0357
73961241|NCT00468910|147458839|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The study was powered to detect an attributable change in the aspirin group of 50% relative to baseline values - an approximate 50% increase in spectral slope.||||0.11
73961242|NCT00468910|147458840|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.17
73961243|NCT01499654|147458875|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
73961244|NCT01499654|147458875|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.67
73961245|NCT01499654|147458876|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73961246|NCT01499654|147458876|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.002
73961247|NCT01499654|147458877|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73961248|NCT01499654|147458877|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.08
73961249|NCT01499654|147458878|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
73961250|NCT01499654|147458878|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.44
73961251|NCT01503749|147458882|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
73961252|NCT04090190|147458883|SUPERIORITY|||||||0.6497|||||||Wilcoxon (Mann-Whitney)|||T-test of Wilcoxon rank sum was used to test this non-normal data. Null hypothesis is that the concentration of urine inflammatory markers is the same at baseline and follow-up. This p-value is the probability that the difference in the CRP Calc. Conc. (pg/ml) between baseline and follow-up.||||0.6497
73961253|NCT04090190|147458883|SUPERIORITY|||||||0.4281|||||||Wilcoxon (Mann-Whitney)|||T-test of Wilcoxon rank sum was used to test this non-normal data. Null hypothesis is that the concentration of urine inflammatory markers is the same at baseline and follow-up. This p-value is the probability that the difference in the IL-12/IL-23p40 Calc. Conc. (pg/ml) between baseline and follow-up.||||0.4281
73961254|NCT04090190|147458883|SUPERIORITY|||||||0.3157|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of MCP-1 Calc. Conc. (pg/ml) is due to chance.||||0.3157
73961255|NCT04090190|147458883|SUPERIORITY|||||||0.1463|||||||Wilcoxon (Mann-Whitney)|||This p-value represents the probability that the difference between baseline and follow-up levels of GM-CSF Calc. Conc. (pg/ml) is due to chance.||||0.1463
73961256|NCT04090190|147458883|SUPERIORITY|||||||0.6091|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-1β Calc. Conc. (pg/ml) is due to chance.||||0.6091
73961257|NCT04090190|147458883|SUPERIORITY|||||||0.3011|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-6 Calc. Conc. (pg/ml) is due to chance.||||0.3011
73961258|NCT04090190|147458883|SUPERIORITY|||||||0.5009|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-8 Calc. Conc. (pg/ml) is due to chance.||||0.5009
73961259|NCT00457691|147458886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.095||||0.8072|TWO_SIDED|95.0|0.892|1.344||p-value from 1-sided log-rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank|||||1.344|0.892|0.8072
73961260|NCT00457691|147458887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.9163|TWO_SIDED|95.0|0.936|1.466||p-value from 1-sided log-rank test, stratified by ECOG performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank|||||1.466|0.936|0.9163
73961261|NCT02079844|147458894|SUPERIORITY_OR_OTHER||LS Mean Difference|0.232|STANDARD_ERROR_OF_MEAN|0.7313||0.753|TWO_SIDED|95.0|-1.269|1.733||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||1.733|-1.269|0.753
73961262|NCT02079844|147458894|SUPERIORITY_OR_OTHER||LS Mean Difference|0.133|STANDARD_ERROR_OF_MEAN|0.7417||0.859|TWO_SIDED|95.0|-1.389|1.655||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||1.655|-1.389|0.859
73961263|NCT02079844|147458895|SUPERIORITY_OR_OTHER||LS Mean Difference|1.938|STANDARD_ERROR_OF_MEAN|1.2436||0.131|TWO_SIDED|95.0|-0.614|4.49||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||4.490|-0.614|0.131
73961264|NCT02079844|147458895|SUPERIORITY_OR_OTHER||LS Mean Difference|2.377|STANDARD_ERROR_OF_MEAN|1.2545||0.069|TWO_SIDED|95.0|-0.198|4.951||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||4.951|-0.198|0.069
73849605|NCT02948582|147245145|SUPERIORITY||least squares mean|0.072||||0.0008|TWO_SIDED|95.0|0.03|0.113|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.113|0.030|0.0008
73849606|NCT02948582|147245145|SUPERIORITY||least squares mean|0.102|||<|0.0001|TWO_SIDED|95.0|0.061|0.144|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.144|0.061|<0.0001
73849607|NCT02948582|147245145|SUPERIORITY||least squares mean|0.108|||<|0.0001|TWO_SIDED|95.0|0.066|0.15|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.150|0.066|<0.0001
73849608|NCT02948582|147245145|SUPERIORITY||least squares mean|0.098|||<|0.0001|TWO_SIDED|95.0|0.056|0.14|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.140|0.056|<0.0001
73849609|NCT02948582|147245146|SUPERIORITY||least squares mean|0.086|||<|0.0001|TWO_SIDED|95.0|0.05|0.123|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.123|0.050|<0.0001
73849610|NCT02948582|147245146|SUPERIORITY||least squares mean|0.151|||<|0.0001|TWO_SIDED|95.0|0.114|0.187|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.187|0.114|<0.0001
73849611|NCT02948582|147245146|SUPERIORITY||least squares mean|0.156|||<|0.0001|TWO_SIDED|95.0|0.12|0.193|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.193|0.120|<0.0001
73849612|NCT02948582|147245146|SUPERIORITY||least squares mean|0.202|||<|0.0001|TWO_SIDED|95.0|0.165|0.239|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.239|0.165|<0.0001
73849613|NCT02948582|147245146|SUPERIORITY||least squares mean|0.199|||<|0.0001|TWO_SIDED|95.0|0.162|0.235|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.235|0.162|<0.0001
73849614|NCT02948582|147245147|SUPERIORITY||least squares mean|0.058||||0.0028|TWO_SIDED|95.0|0.021|0.095|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.095|0.021|0.0028
73849615|NCT02948582|147245147|SUPERIORITY||least squares mean|0.1|||<|0.0001|TWO_SIDED|95.0|0.063|0.137|||least squares mena|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.137|0.063|<0.0001
73849616|NCT02948582|147245147|SUPERIORITY||least squares mean|0.105|||<|0.0001|TWO_SIDED|95.0|0.068|0.142|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.142|0.068|<0.0001
73849617|NCT02948582|147245147|SUPERIORITY||least squares mean|0.135|||<|0.0001|TWO_SIDED|95.0|0.098|0.173|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.173|0.098|<0.0001
73849618|NCT02948582|147245147|SUPERIORITY||least squares mean|0.128|||<|0.0001|TWO_SIDED|95.0|0.091|0.166|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.166|0.091|<0.0001
73849619|NCT01151020|147245164|SUPERIORITY_OR_OTHER_LEGACY||Free from major adverse event rate (%)|96.4|||<|0.001|TWO_SIDED|95.0|91.0|99.0|||Exact binomial test|||Null hypothesis: The 30-day freedom from MAE for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.6%.||99|91|< 0.001
73849620|NCT01151020|147245165|SUPERIORITY_OR_OTHER_LEGACY||Device success rate (%)|92.7|||<|0.001|TWO_SIDED|95.0|86.2|96.8|||Exact binomial test|||Null Hypothesis: The 12-month device success for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.7%.||96.8|86.2|< 0.001
73849621|NCT02389465|147245166|OTHER|||||||0.44|||||||t-test, 2 sided|||IL6 levels in healthy controls pre- and post-treatment compared using a paired t-test||||.44
73849622|NCT02389465|147245166|OTHER|||||||0.11|||||||t-test, 2 sided|||IL6 levels in the placebo group pre- and post-treatment compared using a paired t-test||||.11
73849623|NCT02389465|147245166|OTHER|||||||0.42|||||||t-test, 2 sided|||IL6 levels in the escitalopram group pre- and post-treatment compared using a paired t-test||||.42
73849624|NCT02389465|147245166|OTHER|||||||0.49|||||||t-test, 2 sided|||IL-6 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-tes||||.49
73849625|NCT02389465|147245166|OTHER|||||||0.23|||||||t-test, 2 sided|||IL6 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group||||.23
73849626|NCT02389465|147245167|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and escitalopram + celecoxib groups||||.003
73849627|NCT02389465|147245167|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and escitalopram groups||||<.001
73961265|NCT02079844|147458896|SUPERIORITY_OR_OTHER||LS Mean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.1757||0.671|TWO_SIDED|95.0|-0.739|0.106||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||0.106|-0.739|0.671
73849628|NCT02389465|147245167|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and placebo groups||||.034
73849629|NCT02389465|147245167|SUPERIORITY|||||||0.03|||||||ANCOVA|||MADRS scores at the final visit compared between the placebo groups and all groups receiving escitalopram (both with and without celecoxib)||||.03
73849630|NCT02389465|147245168|OTHER|||||||0.29|||||||t-test, 2 sided|||IL10 levels in healthy controls pre- and post-treatment compared using a paired t-test||||.29
73849631|NCT02389465|147245168|OTHER|||||||0.19|||||||t-test, 2 sided|||IL10 levels in the placebo group pre- and post-treatment compared using a paired t-test||||.19
73849632|NCT02389465|147245168|OTHER|||||||0.5|||||||t-test, 2 sided|||IL10 levels in the escitalopram group pre- and post-treatment compared using a paired t-test||||.5
73849633|NCT02389465|147245168|OTHER|||||||0.55|||||||t-test, 2 sided|||IL10 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-test||||.55
73849634|NCT02389465|147245168|OTHER|||||||0.06|||||||t-test, 2 sided|||IL10 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group||||.06
73849635|NCT00361972|147245195|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73849636|NCT00361972|147245196|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
73849637|NCT00503425|147245198|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 1.|t-test, 2 sided|||||||<0.0001
73849638|NCT00503425|147245198|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 2.|t-test, 2 sided|||||||<0.0001
73849639|NCT00503425|147245198|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 3.|t-test, 2 sided|||||||<0.0001
73849640|NCT00503425|147245198|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 4.|t-test, 2 sided|||||||0.0001
73849641|NCT00149799|147245212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.73||||0.048|TWO_SIDED|95.0|1.01|8.59|||Regression, Cox|p-value is based on the likelihood ratio Chi-Square statistic.||Cox proportional hazards regression was used to compare relapse rates (accounting for censoring and time from randomization to relapse) in Phase II.||8.59|1.01|0.048
73849642|NCT00149799|147245214|SUPERIORITY||Slope difference|-0.07006|STANDARD_ERROR_OF_MEAN|0.04163||0.093|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=556||"We compared change in depression over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in depression symptom severity in the Escitalopram group will not be significantly different from the placebo group \[to be tested\]."||||0.0930
73849643|NCT00149799|147245215|SUPERIORITY||Slope difference|0.001176|STANDARD_ERROR_OF_MEAN|0.03991||0.9766|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=43||"We compared change in functional impairment over time during trial phase 2 by treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in functional impairment in the Escitalopram group will not be significantly different from that of the placebo group \[to be tested\]."||||0.9766
73961266|NCT02079844|147458896|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.171|STANDARD_ERROR_OF_MEAN|0.1757||0.345|TWO_SIDED|95.0|-1.193|0.571||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||0.571|-1.193|0.345
73849644|NCT00149799|147245216|SUPERIORITY||Slope difference|0.05723|STANDARD_ERROR_OF_MEAN|0.1963||0.7724|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=36||"We compared change in Q-LES-Q-SF percent scores over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in Q-LES-Q-SF percent scores in the Escitalopram group will not be significantly different from that of the placebo group \[to be tested\]."||||0.7724
73849645|NCT00437268|147245217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.431||||||The type 1 error rate was set at 0.20|Log Rank|||||||0.431
73849646|NCT00437268|147245218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.593|||||||Fisher Exact|||||||0.593
73849647|NCT00437268|147245219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.157|||||||Log Rank|||||||0.157
73849648|NCT00437268|147245220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||||||Kaplan-Meier analysis was used for statistical analysis.|Log Rank|||||||0.539
73849649|NCT00437268|147245221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.695|||||||Fisher Exact|||||||0.695
73849650|NCT00444925|147245223|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).||||<0.0001
73849651|NCT00444925|147245223|SUPERIORITY_OR_OTHER|||||||0.0107||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0107
73849652|NCT00444925|147245223|SUPERIORITY_OR_OTHER|||||||0.0172||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0172
73849653|NCT00444925|147245224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
73849654|NCT00444925|147245224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
73849655|NCT00444925|147245224|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.8460
73849656|NCT00444925|147245224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
73849657|NCT00444925|147245224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
73849658|NCT00444925|147245224|SUPERIORITY_OR_OTHER|||||||0.1937||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.1937
73849659|NCT00444925|147245225|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
73849660|NCT00444925|147245225|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
73849661|NCT00444925|147245225|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
73849662|NCT00444925|147245225|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
73849663|NCT00444925|147245225|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
73849664|NCT00444925|147245225|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
73849665|NCT00444925|147245225|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0220
73849666|NCT00444925|147245226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|3.4||0.0214|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference Least Squares Mean (LSMean) Difference Standard Error (SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0214
73849667|NCT00444925|147245226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.2|STANDARD_ERROR_OF_MEAN|3.4||0.0149|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0149
73849668|NCT00444925|147245226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.7||0.8659|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.8659
73849669|NCT00444925|147245226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
73849670|NCT00444925|147245226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|4.0||0.0036|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.0036
73849671|NCT00444925|147245226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|3.3||0.1484|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1484
73961267|NCT00304031|147458917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.63|TWO_SIDED|95.0|0.88|1.2||One-sided|Log Rank||Reference level = Conventional adjuvant TMZ|This study was looking for a 20% reduction in hazard rate: null hypothesis (conventional arm): Median survival time (MST) = 14.0 mo.; alternative hypothesis (dose-dense arm): MST= 17.5 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 750 patients (647 deaths were required for the final analysis).||1.20|0.88|0.63
73849672|NCT00444925|147245226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
73961268|NCT00304031|147458918|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.06|TWO_SIDED|95.0|0.75|1.0||Two-side significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|||1.00|0.75|0.06
73849673|NCT00444925|147245226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|4.1||0.1029|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.1029
73849674|NCT00444925|147245226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|STANDARD_ERROR_OF_MEAN|3.3||0.0048|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0048
73849675|NCT00444925|147245227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0002|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0002
73849676|NCT00444925|147245227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0006|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0006
73849677|NCT00444925|147245227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7395|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7395
73849678|NCT00444925|147245227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
73849679|NCT00444925|147245227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0007|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.0007
73849680|NCT00444925|147245227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4185|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.4185
73849681|NCT00444925|147245227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
73849682|NCT00444925|147245227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0005|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0005
73849683|NCT00444925|147245227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3798|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.3798
73849684|NCT00444925|147245228|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0001
73849685|NCT00444925|147245228|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0002
73849686|NCT00444925|147245228|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
73961269|NCT00304031|147458919|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.44|TWO_SIDED|95.0|0.82|1.19||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Unmethylated MGMT||1.19|0.82|0.44
73961270|NCT00304031|147458919|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.86|TWO_SIDED|95.0|0.87|1.62||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Methylated MGMT||1.62|0.87|0.86
73961271|NCT00304031|147458920|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.15|TWO_SIDED|95.0|0.73|1.05||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Unmethylated MGMT||1.05|0.73|0.15
73961272|NCT00304031|147458920|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.33|TWO_SIDED|95.0|0.66|1.15||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Methylated MGMT||1.15|0.66|0.33
73961273|NCT00304031|147458921|SUPERIORITY|||||||0.012||||||Two-sided significance level of 0.05|Chi-squared|||||||0.012
73961274|NCT00304031|147458922|SUPERIORITY||||||<|0.001|||||||Chi-squared|Two-sided significance level of 0.05||||||<0.001
73961275|NCT00304031|147458923|SUPERIORITY||||||<|0.001||||||Two-sided test|Log Rank|||||||<0.001
73961276|NCT00304031|147458924|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
73961277|NCT00304031|147458925|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
73961278|NCT00304031|147458926|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
73961279|NCT00304031|147458927|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
73961280|NCT00304031|147458928|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
73961281|NCT00304031|147458929|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.74
73961282|NCT00304031|147458930|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
73961283|NCT00304031|147458931|SUPERIORITY|||||||0.2184|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.2184
73961284|NCT00304031|147458931|SUPERIORITY|||||||0.0763|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. RPA class is reported here.||||0.0763
73961285|NCT00304031|147458931|SUPERIORITY|||||||0.5235|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. MGMT status is reported here.||||0.5235
73961286|NCT00304031|147458932|SUPERIORITY|||||||0.03|||||||Z-test of two proportions|||||||0.03
73961287|NCT00304031|147458933|SUPERIORITY|||||||0.03|||||||Z-test of two proportions|||||||0.03
73961288|NCT00304031|147458934|SUPERIORITY|||||||0.0002|||||||Chi-squared|Two-sided test||||||0.0002
73961289|NCT00304031|147458935|SUPERIORITY|||||||0.005|||||||Fisher Exact|Two-sided test||||||0.005
73961290|NCT00304031|147458936|SUPERIORITY|||||||0.018|||||||Fisher Exact|Two-sided test||||||0.018
73961291|NCT00304031|147458937|SUPERIORITY|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||||||0.1702|||||||Mixed Models Analysis|||A mixed effects model was run with MDASI Symptom Severity Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.1702
73961292|NCT00304031|147458937|SUPERIORITY|||||||0.8159|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.||||0.8159
73961293|NCT00304031|147458937|SUPERIORITY|||||||0.2174|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT status is reported here.||||0.2174
73961294|NCT00304031|147458938|OTHER|||||||0.023|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. EORTC physical functioning is reported here.||||0.023
73961295|NCT00304031|147458938|OTHER|||||||0.043|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized HVLT-R recognition is reported here.||||0.043
73961296|NCT00304031|147458938|OTHER|||||||0.021|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized COWA is reported here.||||0.021
73961297|NCT00304031|147458939|SUPERIORITY|||||||0.2357|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.2357
73961298|NCT00304031|147458939|SUPERIORITY|||||||0.0147|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.||||0.0147
73961299|NCT00304031|147458939|SUPERIORITY|||||||0.457|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT Status is reported here.||||0.457
73961300|NCT00304031|147458940|SUPERIORITY|||||||0.02|||||||Chi-squared|Two-sided test||||||0.02
73961301|NCT00304031|147458941|SUPERIORITY|||||||0.99|||||||Fisher Exact|Two-sided test||||||0.99
73961302|NCT00304031|147458942|SUPERIORITY|||||||0.33|||||||Fisher Exact|Two-sided test||||||0.33
73961303|NCT02396316|147458950|SUPERIORITY_OR_OTHER||Difference of LS mean change|-4.9||||0.0644|TWO_SIDED|95.0|-10.2|0.3|||ANCOVA|||Point estimate, 95% CI and P-value were based on treatment difference of the LS mean changes using an ANCOVA model with treatment group and stage of NVG for randomization as fixed effects, baseline value as covariate. The superiority of aflibercept injection to sham injection was to be established if the upper limit of the two-sided 95% confidence interval for the difference (the aflibercept group minus the sham group) is less than 0.||0.3|-10.2|0.0644
73961304|NCT02396316|147458951|SUPERIORITY_OR_OTHER||MH adjusted difference|59.1|||||TWO_SIDED|95.0|37.0|81.2|||Mantel Haenszel|||The point estimate of the treatment difference (the aflibercept group minus the sham group) at Week 1 and its two-sided 95% confidence interval stratified by stage of NVG (as randomized) using Mantel-Haenszel weights.||81.2|37.0|
73961305|NCT02731755|147458975|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||Between time points and treatments, calculated p value||||0.5
73961306|NCT02731755|147458976|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Ach-iAUC||||0.04
73961307|NCT02731755|147458976|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||SNP-IAUC||||0.007
73961308|NCT02731755|147458976|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Ach - AUC||||0.02
73961309|NCT02731755|147458977|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.9
73961310|NCT02731755|147458979|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.7
73961311|NCT00773370|147458995|SUPERIORITY_OR_OTHER||difference between slopes|8.43|STANDARD_DEVIATION|7.17|<|0.25|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||<0.25
73961312|NCT00773370|147458995|SUPERIORITY_OR_OTHER||Slope|14.95|STANDARD_DEVIATION|4.92|<|0.004|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||<0.004
73961313|NCT00773370|147458995|SUPERIORITY_OR_OTHER||Slope|6.52|STANDARD_DEVIATION|5.13||0.218|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.218
73961314|NCT00773370|147458996|SUPERIORITY_OR_OTHER||Difference between slopes|0.186|STANDARD_DEVIATION|0.256||0.47|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||.47
73961315|NCT00773370|147458996|SUPERIORITY_OR_OTHER||Slope|0.215|STANDARD_DEVIATION|0.175||0.225|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.225
73961316|NCT00773370|147458996|SUPERIORITY_OR_OTHER||Slope|0.029|STANDARD_DEVIATION|0.187||0.88|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.88
73961317|NCT00773370|147458997|SUPERIORITY_OR_OTHER||Difference between slopes|0.002|STANDARD_DEVIATION|0.078||0.98|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||.98
73961318|NCT00773370|147458997|SUPERIORITY_OR_OTHER||Slope|0.033|STANDARD_DEVIATION|0.054||0.54|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.54
73961319|NCT00773370|147458997|SUPERIORITY_OR_OTHER||Slope|0.031|STANDARD_DEVIATION|0.057||0.59|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.59
73961320|NCT00773370|147458998|SUPERIORITY_OR_OTHER||Slope|0.296|STANDARD_DEVIATION|9.77||0.98|TWO_SIDED||||||ANOVA|||Random effects ANOVA with random intercept and random slope was used to compare the time course of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.||||.98
73961321|NCT00773370|147458998|SUPERIORITY_OR_OTHER||Slope|15.49|STANDARD_DEVIATION|6.19||0.02|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||||||.02
73849687|NCT00444925|147245228|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
73849688|NCT00444925|147245228|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
73849689|NCT00444925|147245228|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0003
73849690|NCT00444925|147245229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.273|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.2730
73849691|NCT00444925|147245229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0652|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0652
73849692|NCT00444925|147245229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.3503|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.3503
73961322|NCT00773370|147458998|SUPERIORITY_OR_OTHER||Slope|15.193|STANDARD_DEVIATION|7.553||0.051|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||||||.051
73961323|NCT01112670|147459007|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||||||0.83
73961324|NCT01112670|147459008|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
73849693|NCT00444925|147245229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2667|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||0.2667
73961325|NCT01112670|147459009|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||||||0.90
73961326|NCT01112670|147459010|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||||||0.56
73961327|NCT01112670|147459011|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
73961328|NCT01112670|147459012|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||||||0.86
73961329|NCT01112670|147459013|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANOVA|||||||0.21
73961330|NCT01112670|147459014|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
73961331|NCT01112670|147459015|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
73961332|NCT01112670|147459016|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANOVA|||||||0.29
73961333|NCT01112670|147459017|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||||||0.43
73961334|NCT00779870|147459027|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
73961335|NCT00779870|147459027|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
73961336|NCT03593213|147459053|SUPERIORITY||Hazard Ratio (HR)|0.56|||=|0.1576|TWO_SIDED|95.0|0.25|1.29||The significance level was 0.05 using the log rank test.|Log Rank||Hazard ratio (cariprazine 3.0 or 4.5 mg/day vs. placebo) was based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||1.29|0.25|=0.1576
73961337|NCT03593213|147459053|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.2066|TWO_SIDED|95.0|0.26|1.45||The significance level was 0.05 using the log rank test.|Log Rank||Hazard ratio (cariprazine 3.0 or 4.5 mg/day vs. placebo) was based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||1.45|0.26|=0.2066
73961338|NCT04589689|147459054|OTHER|||||||0.777||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3 months.||||0.777
73961339|NCT04589689|147459054|OTHER|||||||0.247||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month.||||0.247
73961340|NCT04589689|147459055|OTHER|||||||0.16||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.160
73961341|NCT04589689|147459055|OTHER|||||||0.275||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.275
73961342|NCT04589689|147459056|OTHER|||||||0.509||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.509
73849694|NCT00444925|147245229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1643|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.1643
73849695|NCT00444925|147245229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7264|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.7264
73849696|NCT00444925|147245229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3269|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||0.3269
73849697|NCT00444925|147245229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5059|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.5059
73849698|NCT00444925|147245229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.699|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.6990
73849699|NCT00444925|147245231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0008
73849700|NCT00444925|147245231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
73849701|NCT00444925|147245231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.382|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.3820
73961343|NCT04589689|147459056|OTHER|||||||0.61||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.610
73961344|NCT04589689|147459057|OTHER|||||||0.807||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.807
73961345|NCT04589689|147459057|OTHER|||||||0.826||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.826
73961346|NCT04589689|147459058|OTHER|||||||0.076||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.076
73961347|NCT04589689|147459058|OTHER|||||||0.747||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.747
73961348|NCT04589689|147459059|OTHER|||||||0.154||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.154
73961349|NCT04589689|147459059|OTHER|||||||0.107||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.107
73961350|NCT04589689|147459060|OTHER|||||||0.445||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.445
73961351|NCT04589689|147459060|OTHER|||||||0.543||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.543
73961352|NCT04589689|147459061|OTHER|||||||0.157||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.157
73961353|NCT02594735|147459066|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
73961354|NCT02594735|147459067|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73961355|NCT02594735|147459068|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
73961356|NCT02594735|147459069|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73961357|NCT02594735|147459070|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73961358|NCT02594735|147459071|OTHER|||||||0.375|||||||t-test, 2 sided|||||||0.375
73961359|NCT02594735|147459072|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73961360|NCT02594735|147459073|OTHER|||||||0.044|||||||Sign test|Data was not normally distributed||||||0.044
73961361|NCT02594735|147459074|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
73961362|NCT03844269|147459088|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||EEG data excluded if excessive noise (rejection of more than 30% of target trials due to voltage fluctuations greater than ± 100 μV deflections within an epoch) at the pre- or post-intervention assessment||||<0.05
73961363|NCT00475319|147459090|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||versus placebo|t-test, 2 sided|a general linear model||||||0.001
73961364|NCT00475319|147459091|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||versus placebo|t-test, 2 sided|a general linear model||||||0.001
73961365|NCT05082935|147459110|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.09|TWO_SIDED|95.0|-0.008|0.104|||ANCOVA|||||0.104|-0.008|0.09
73961366|NCT05082935|147459111|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.02|TWO_SIDED|95.0|0.02|0.29|||ANCOVA|||||0.29|0.02|0.02
73961367|NCT05082935|147459112|SUPERIORITY||Ratio of Means|-0.076||||0.03|TWO_SIDED|95.0|-0.145|-0.007|||ANCOVA|||||-0.007|-0.145|0.03
73961368|NCT05082935|147459113|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.38|TWO_SIDED|95.0|-0.04|0.09|||ANCOVA|||||0.09|-0.04|0.38
73961369|NCT05082935|147459114|SUPERIORITY||Mean Difference (Final Values)|0.096||||0.002|TWO_SIDED|95.0|0.04|0.16|||ANCOVA|||||0.16|0.04|0.002
73961370|NCT03482011|147459123|SUPERIORITY||Risk Difference (RD)|63.0|||<|0.001|TWO_SIDED|95.0|56.5|69.4|||Cochran-Mantel-Haenszel|||||69.4|56.5|<0.001
73961371|NCT03482011|147459124|SUPERIORITY||Risk Difference (RD)|57.8|||<|0.001|TWO_SIDED|95.0|51.3|64.4|||Cochran-Mantel-Haenszel|||||64.4|51.3|<0.001
73961372|NCT03482011|147459125|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|11.6|19.7|||Cochran-Mantel-Haenszel|||||19.7|11.6|<0.001
73961373|NCT03482011|147459126|SUPERIORITY||Risk Difference (RD)|73.6|||<|0.001|TWO_SIDED|95.0|67.1|80.1|||Cochran-Mantel-Haenszel|||||80.1|67.1|<0.001
73961374|NCT03482011|147459127|SUPERIORITY||Risk Difference (RD)|30.8|||<|0.001|TWO_SIDED|95.0|26.0|35.7|||Cochran-Mantel-Haenszel|||||35.7|26.0|<0.001
73961375|NCT03482011|147459128|SUPERIORITY||Risk Difference (RD)|48.1|||<|0.001|TWO_SIDED|95.0|42.9|53.2|||Cochran-Mantel-Haenszel|||||53.2|42.9|<0.001
73961376|NCT03482011|147459129|SUPERIORITY||Risk Difference (RD)|18.3|||<|0.001|TWO_SIDED|95.0|14.5|22.1|||Cochran-Mantel-Haenszel|||||22.1|14.5|<0.001
73961377|NCT03482011|147459130|SUPERIORITY||Risk Difference (RD)|49.6|||<|0.001|TWO_SIDED|95.0|42.8|56.4|||Cochran-Mantel-Haenszel|||||56.4|42.8|<0.001
73961378|NCT03482011|147459131|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|56.0|77.5|||Cochran-Mantel-Haenszel|||||77.5|56.0|<0.001
73961379|NCT03482011|147459131|SUPERIORITY||Risk Difference (RD)|65.9|||<|0.001|TWO_SIDED|95.0|54.9|77.0|||Cochran-Mantel-Haenszel|||||77.0|54.9|<0.001
73961380|NCT03482011|147459132|SUPERIORITY||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|1.32|<|0.001|TWO_SIDED|95.0|-7.31|-2.1|||Mixed Models Analysis|||||-2.10|-7.31|<0.001
73961381|NCT03482011|147459133|SUPERIORITY||Mean Difference (Net)|-17.33|STANDARD_ERROR_OF_MEAN|0.99|<|0.001|TWO_SIDED|95.0|-19.28|-15.39|||Mixed Models Analysis|||||-15.39|-19.28|<0.001
73849702|NCT00444925|147245231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
73849703|NCT00444925|147245231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
73849704|NCT00444925|147245231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3498|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.3498
73849705|NCT00444925|147245231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
73849706|NCT00444925|147245231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
73849707|NCT00444925|147245231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0542|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0542
73849708|NCT00444925|147245232|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0004
73849709|NCT00444925|147245232|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0001
73849710|NCT00444925|147245232|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
73961382|NCT03482011|147459134|SUPERIORITY||Mean Difference (Net)|-6.98|STANDARD_ERROR_OF_MEAN|1.73|<|0.001|TWO_SIDED|95.0|-10.37|-3.58|||Mixed Models Analysis|||||-3.58|-10.37|<0.001
73849711|NCT00444925|147245232|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
73849712|NCT00444925|147245232|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
73961383|NCT03482011|147459135|SUPERIORITY||Mean Difference (Net)|4.86|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|3.5|6.22|||ANCOVA|||||6.22|3.50|<0.001
73961384|NCT03482011|147459136|SUPERIORITY||Mean Difference (Net)|4.78|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|3.33|6.23|||ANCOVA|||||6.23|3.33|<0.001
73961385|NCT03482011|147459137|SUPERIORITY||Risk Difference (RD)|68.1|||<|0.001|TWO_SIDED|95.0|63.2|72.9|||Cochran-Mantel-Haenszel|||||72.9|63.2|<0.001
73961386|NCT03482011|147459138|SUPERIORITY||Mean Difference (Net)|-3.68|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|-7.3|-0.06|||ANOVA|||Absenteeism||-0.06|-7.30|0.002
73849713|NCT00444925|147245232|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0001
73849714|NCT00444925|147245233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
73849715|NCT00444925|147245233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
73849716|NCT00444925|147245233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5581|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.5581
73849717|NCT00444925|147245233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
73849718|NCT00444925|147245233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
73849719|NCT00444925|147245233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.151|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1510
73849720|NCT00444925|147245233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
73849721|NCT00444925|147245233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2||0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0001
73849722|NCT00444925|147245233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1391|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.1391
73849723|NCT00444925|147245234|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
73849724|NCT00444925|147245234|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
73849725|NCT00444925|147245234|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
73849726|NCT00444925|147245234|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
74023795|NCT01381094|147600240|SUPERIORITY||||||=|0.8516|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.8516
74023796|NCT01381094|147600240|SUPERIORITY||||||=|0.0017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0017
74023797|NCT01381094|147600240|SUPERIORITY||||||=|0.0656|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0656
73849727|NCT00444925|147245234|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
73849728|NCT00444925|147245234|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0001
73849729|NCT00444925|147245235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
73849730|NCT00444925|147245235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
73849731|NCT00444925|147245235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5972|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.5972
73849732|NCT00444925|147245235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
73849733|NCT00444925|147245235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
73849734|NCT00444925|147245235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.1267|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1267
73849735|NCT00444925|147245235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
73849736|NCT00444925|147245235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
74023798|NCT01381094|147600240|SUPERIORITY||||||=|0.6495|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6495
74023799|NCT01381094|147600241|SUPERIORITY||||||=|0.2065|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.2065
73849737|NCT00444925|147245235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0289|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0289
73961387|NCT03482011|147459138|SUPERIORITY||Mean Difference (Net)|-20.24|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-24.89|-15.6|||ANCOVA|||Presenteeism||-15.60|-24.89|<0.001
73961388|NCT03482011|147459138|SUPERIORITY||Mean Difference (Net)|-21.09|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-26.56|-15.62|||ANCOVA|||Overall Absenteeism and Presenteeism||-15.62|-26.56|<0.001
73961389|NCT03482011|147459138|SUPERIORITY||Mean Difference (Net)|-22.91|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-27.39|-18.43|||ANCOVA|||Impairment in Activities Performed Outside of Work||-18.43|-27.39|<0.001
73961390|NCT03482011|147459139|SUPERIORITY||Mean Difference (Net)|0.53|STANDARD_ERROR_OF_MEAN|1.79||0.004|TWO_SIDED|95.0|-3.08|4.14|||ANCOVA|||||4.14|-3.08|0.004
73961391|NCT03482011|147459140|SUPERIORITY||Risk Difference (RD)|48.8|||<|0.001|TWO_SIDED|95.0|41.6|55.9|||Cochran-Mantel-Haenszel|||||55.9|41.6|<0.001
73961392|NCT02476409|147459142|SUPERIORITY|||||||0.094|||||||Kruskal-Wallis|||||||0.094
73961393|NCT02476409|147459143|SUPERIORITY|||||||0.166|||||||Kruskal-Wallis|||||||0.166
73961394|NCT02476409|147459143|SUPERIORITY|||||||0.491|||||||Kruskal-Wallis|||||||0.491
73849738|NCT00444925|147245236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
73849739|NCT00444925|147245236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
73849740|NCT00444925|147245236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.6||0.7288|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7288
73849741|NCT00444925|147245236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
73849742|NCT00444925|147245236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
73849743|NCT00444925|147245236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2473|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.2473
73849744|NCT00444925|147245236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
73849745|NCT00444925|147245236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
74023800|NCT01381094|147600241|SUPERIORITY||||||=|0.1807|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.1807
73849746|NCT00444925|147245236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.1047|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.1047
73849747|NCT00444925|147245237|SUPERIORITY_OR_OTHER|||||||0.0143||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1||||0.0143
73849748|NCT00444925|147245237|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4||||<0.0001
73849749|NCT00444925|147245237|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12||||<0.0001
73849750|NCT00444925|147245238|SUPERIORITY_OR_OTHER|||||||0.0773||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1||||0.0773
73849751|NCT00444925|147245238|SUPERIORITY_OR_OTHER|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4||||0.0017
73849752|NCT00444925|147245238|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12||||0.0008
73961395|NCT02476409|147459144|SUPERIORITY|||||||0.543|||||||Kruskal-Wallis|||P-value for Change in Dyspnea VAS - Baseline to Day 3 Tolvaptan versus placebo.||||0.543
73961396|NCT02476409|147459145|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.050
73961397|NCT02476409|147459146|SUPERIORITY|||||||0.092|||||||Fisher Exact|||||||0.092
73961398|NCT02476409|147459147|SUPERIORITY|||||||0.034|||||||Kruskal-Wallis|||||||0.034
73961399|NCT02476409|147459148|SUPERIORITY|||||||0.643|||||||Kruskal-Wallis|||||||0.643
73849753|NCT00444925|147245239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment difference Fesoterodine vs placebo at Week 12||||<0.0001
73849754|NCT00444925|147245240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL concern domain.||||<0.0001
73849755|NCT00444925|147245240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.||||<0.0001
73849756|NCT00444925|147245240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|1.5||0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.||||0.0008
73849757|NCT00444925|147245240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.||||<0.0001
73849758|NCT00444925|147245240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.||||<0.0001
73849759|NCT00444925|147245241|SUPERIORITY_OR_OTHER|||||||0.0072||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0072
73849760|NCT00444925|147245241|SUPERIORITY_OR_OTHER|||||||0.0116||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0116
73849761|NCT00444925|147245241|SUPERIORITY_OR_OTHER|||||||0.7828||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7828
73849762|NCT00444925|147245241|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
74023801|NCT01381094|147600241|SUPERIORITY||||||=|0.7869|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.7869
73849763|NCT00444925|147245241|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
73849764|NCT00444925|147245241|SUPERIORITY_OR_OTHER|||||||0.3104||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.3104
73849765|NCT00444925|147245241|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
73849766|NCT00444925|147245241|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0004
73849767|NCT00444925|147245241|SUPERIORITY_OR_OTHER|||||||0.0153||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0153
73849768|NCT03382912|147245267|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.3|5.9|||||Odds Ratio stratified based on tumor histology at randomization (interactive web response system (IWRS)), smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.|||5.9|0.3|
73849769|NCT03382912|147245268|SUPERIORITY||Hazard Ratio (HR)|1.006|||||TWO_SIDED|95.0|0.519|1.951|||||The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (interactive web response system (IWRS)) and smoking status (IWRS).|||1.951|0.519|
73849770|NCT03382912|147245269|SUPERIORITY||Hazard Ratio (HR)|1.871|||||TWO_SIDED|95.0|0.772|4.532|||||||The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS).|4.532|0.772|
73849771|NCT03382912|147245270|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.4|4.1|||||Odds Ratio stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.|||4.1|0.4|
73849772|NCT02137070|147245274|SUPERIORITY||||||<|0.01||||||Voxel-size (p-FWE \< 0.01) and voxel-peak (p-unc \< 0.001) were corrected for multiple comparisons.|2x2 Factorial ANOVA in CONN|2x2 Factorial ANOVA in CONN - Group (Bariatric surgery vs. control) \& time (pre-surgery baseline vs. 18-month follow-up)||Analysis of variance comparing change scores from 18 months post-surgery relative to pre-surgical baseline were performed. Change in the surgical group was compared to change for the non-surgical controls. The dependent measures were connectivity strengths seeding from the hippocampus and left dorsal lateral pre-frontal cortex to other cortical areas.||||<0.01
73849773|NCT02292537|147245280|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|0.91||1e-07|TWO_SIDED|95.0|3.1|6.7|||ANCOVA|ANCOVA model with treatment group as a factor and age at Screening and baseline HFMSE score as covariates.||||6.7|3.1|0.0000001
74023802|NCT01381094|147600241|SUPERIORITY||||||=|0.4743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.4743
73849774|NCT02292537|147245281|SUPERIORITY||Odds Ratio (OR)|5.59||||0.0006|TWO_SIDED|95.0|2.09|14.91||Based on multiple imputation and logistic regression with treatment effect and adjustment for each participant's age at screening and HFMSE score at baseline.|Regression, Logistic|||||14.91|2.09|0.0006
74023803|NCT01381094|147600241|SUPERIORITY||||||=|0.6407|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.6407
73849775|NCT02292537|147245281|SUPERIORITY||Difference in Proportions|30.5|||||TWO_SIDED|95.0|12.74|48.31|||||Difference in proportions of Nusinersen minus Sham Procedure are from multiple imputation procedure and are based on binomial proportions.|||48.31|12.74|
73849776|NCT02292537|147245282|SUPERIORITY||Difference in Proportions|13.8||||0.0811|TWO_SIDED|95.0|-6.64|34.17|||Fisher Exact||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||34.17|-6.64|0.0811
73849777|NCT02292537|147245283|SUPERIORITY||LS Mean Difference|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and number of milestones at baseline.|||0.7|0.2|
73961400|NCT01943799|147459224|SUPERIORITY||LS Mean Difference|-0.001||||0.976|TWO_SIDED|95.0|-0.061|0.059|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.059|-0.061|0.976
73849778|NCT02292537|147245284|SUPERIORITY||LS Mean Differenec|3.7|||||TWO_SIDED|95.0|2.3|5.0|||||From multiple imputation procedure, based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and derived total score at baseline.|||5.0|2.3|
73849779|NCT02292537|147245285|SUPERIORITY||Difference in Proportions|-1.4|||||TWO_SIDED|95.0|-21.84|19.34|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||19.34|-21.84|
73849780|NCT02292537|147245286|SUPERIORITY||Difference in Proportions|1.5|||||TWO_SIDED|95.0|-19.1|22.1|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||22.10|-19.10|
73849781|NCT02628444|147245311|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMTs between groups (Group 2/Group 1) was greater than (\>) 1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.862|1.39||||||Group 2/Group 1: Serotype 1||1.39|0.862|
73849782|NCT02628444|147245311|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.993|||||TWO_SIDED|95.0|0.82|1.2||||||Group 2/Group 1: Serotype 2||1.20|0.820|
73849783|NCT02628444|147245311|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.983|||||TWO_SIDED|95.0|0.816|1.18||||||Group 2/Group 1: Serotype 3||1.18|0.816|
73849784|NCT02628444|147245311|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.96|||||TWO_SIDED|95.0|0.809|1.14||||||Group 2/Group 1: Serotype 4||1.14|0.809|
73849785|NCT02628444|147245312|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.757|1.4||||||Group 2/Group 1: Serotype 1||1.40|0.757|
73849786|NCT02628444|147245312|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.897|||||TWO_SIDED|95.0|0.705|1.14||||||Group 2/Group 1: Serotype 2||1.14|0.705|
73849787|NCT02628444|147245312|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.917|||||TWO_SIDED|95.0|0.724|1.16||||||Group 2/Group 1: Serotype 3||1.16|0.724|
73849788|NCT02628444|147245312|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.884|||||TWO_SIDED|95.0|0.72|1.09||||||Group 2/Group 1: Serotype 4||1.09|0.720|
73849789|NCT02628444|147245313|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.567|||||TWO_SIDED|98.75|0.399|0.805||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 1||0.805|0.399|
73961401|NCT01943799|147459224|SUPERIORITY||LS Mean Difference|-0.007||||0.828|TWO_SIDED|95.0|-0.067|0.053|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.053|-0.067|0.828
73961402|NCT01943799|147459224|SUPERIORITY||LS Mean Difference|-0.029||||0.343|TWO_SIDED|95.0|-0.089|0.031|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.031|-0.089|0.343
73849790|NCT02628444|147245313|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.746|||||TWO_SIDED|98.75|0.55|1.01||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 2||1.01|0.550|
73849791|NCT02628444|147245313|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|1.04|||||TWO_SIDED|98.75|0.686|1.57||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 3||1.57|0.686|
73961403|NCT00958633|147459238|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.12|TWO_SIDED|95.0|0.43|1.1|||Log Rank||The hazard ratio for time to any mood episode in the 52-week group relative to the 8-week group was 0.68 (95% confidence interval \[CI\], 0.43 to 1.10; P = 0.12 by log-rank test).|||1.10|0.43|0.12
73961404|NCT00958633|147459239|SUPERIORITY||Hazard Ratio (HR)|2.28|||||TWO_SIDED|95.0|0.86|6.08||||||Manic or Hypomanic events||6.08|.86|
73961405|NCT00958633|147459239|SUPERIORITY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.25|0.75||||||Depressive Events||0.75|0.25|
73961406|NCT06243796|147459242|SUPERIORITY||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
73961407|NCT06243796|147459243|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
73961408|NCT01395758|147459291|SUPERIORITY|||||||0.5017|||||||Log Rank|||||||0.5017
73961409|NCT01395758|147459292|SUPERIORITY|||||||0.4356|||||||Log Rank|||||||0.4356
73961410|NCT00357097|147459302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|||<|0.001||95.0|-5.6|-1.6|||ANCOVA||Mean difference = Ropinirole minus Placebo. Used adjusted change from baseline.|||-1.6|-5.6|<0.001
73961411|NCT00262730|147459389|NON_INFERIORITY_OR_EQUIVALENCE|study design has 85% power to detect 25% deduction in hazard rate compared to EORTC Phase 3 results.|Hazard Ratio (HR)|0.8|STANDARD_DEVIATION|0.025|>|0.1|TWO_SIDED|95.0|0.8|0.85|||Log Rank|||||0.85|0.8|>.1
73961412|NCT03887650|147459399|SUPERIORITY|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||||||0.127
74084727|NCT03653026|147722720|SUPERIORITY||Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|29.8|46.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||46.1|29.8|<0.001
73849792|NCT02628444|147245313|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.647|||||TWO_SIDED|98.75|0.434|0.963||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 4||0.963|0.434|
73849793|NCT02628444|147245314|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.627|||||TWO_SIDED|98.75|0.342|1.15||||||Group 2a Booster dose/Group 1 Post-dose 3: Serotype 1||1.15|0.342|
73849794|NCT02628444|147245314|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.809|||||TWO_SIDED|98.75|0.505|1.3||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 2||1.30|0.505|
73849795|NCT02628444|147245314|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.19|||||TWO_SIDED|98.75|0.732|1.94||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 3||1.94|0.732|
73849796|NCT02628444|147245314|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.499|||||TWO_SIDED|98.75|0.331|0.754||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 4||0.754|0.331|
73849797|NCT02628444|147245315|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.688|||||TWO_SIDED|98.75|0.479|0.989||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 1||0.989|0.479|
73961413|NCT03887650|147459400|SUPERIORITY|||||||0.975|||||||Wilcoxon (Mann-Whitney)|||||||.975
73961414|NCT03887650|147459401|SUPERIORITY|||||||0.852||||||PACU pain scores|Wilcoxon (Mann-Whitney)|||||||.852
73961415|NCT03887650|147459401|SUPERIORITY|||||||0.661||||||For (PACU-24) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.661
73961416|NCT03887650|147459401|SUPERIORITY|||||||0.747||||||For (PACU-24 hr.) maximum pain score|Wilcoxon (Mann-Whitney)|||||||.747
73961417|NCT03887650|147459401|SUPERIORITY|||||||0.604||||||For (PACU-24 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.604
73961418|NCT03887650|147459401|SUPERIORITY|||||||0.002||||||(24-48 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.002
73961419|NCT03887650|147459401|SUPERIORITY||||||<|0.01||||||For (24-48 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||<0.01
73961420|NCT03887650|147459401|SUPERIORITY||||||<|0.01||||||For (24-48 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||<0.01
73961421|NCT03887650|147459401|SUPERIORITY|||||||0.011||||||(48-72 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.011
73961422|NCT03887650|147459401|SUPERIORITY|||||||0.001||||||(48-72 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.001
73961423|NCT03887650|147459401|SUPERIORITY|||||||0.003||||||(48-72 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.003
73961424|NCT03887650|147459401|SUPERIORITY|||||||0.23||||||For (72-96 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.230
73961425|NCT03887650|147459401|SUPERIORITY|||||||0.007||||||For (72-96 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.007
73961426|NCT03887650|147459401|SUPERIORITY|||||||0.011||||||For (72-96 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.011
73961427|NCT03887650|147459401|SUPERIORITY|||||||0.378||||||For (postoperative day 60) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.378
74023804|NCT01381094|147600242|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
74023805|NCT01381094|147600242|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
73961428|NCT03887650|147459401|SUPERIORITY|||||||0.001||||||For (postoperative day 60) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.001
73961429|NCT03887650|147459401|SUPERIORITY|||||||0.403||||||For (postoperative day 60) average pain scores|Wilcoxon (Mann-Whitney)|||||||.403
73961430|NCT03887650|147459402|SUPERIORITY|||||||0.112|||||||Wilcoxon (Mann-Whitney)|||||||.112
74023806|NCT01381094|147600242|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
74023807|NCT01381094|147600242|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
73961431|NCT03887650|147459403|SUPERIORITY|||||||0.096||||||P-Value for POD4|Fisher Exact|Fisher's Exact for POD4||||||0.096
73961432|NCT03887650|147459403|SUPERIORITY|||||||1||||||For POD60|Chi-squared|Chi-squared for POD60||||||1.0
73961433|NCT03887650|147459404|SUPERIORITY|||||||1||||||Any distress on PACU|Chi-squared|||||||1.0
73961434|NCT03887650|147459404|SUPERIORITY|||||||0.947||||||Postoperative day 2|Chi-squared|||||||.947
73961435|NCT03887650|147459405|SUPERIORITY|||||||0.441||||||Full sensation|Fishers Freeman Halton|||||||.441
73961436|NCT03887650|147459405|SUPERIORITY|||||||0.691||||||First sensation|Fishers Freeman Halton|||||||.691
73961437|NCT03887650|147459406|SUPERIORITY|||||||0.876|||||||Wilcoxon (Mann-Whitney)|||||||.876
73961438|NCT03887650|147459407|SUPERIORITY|||||||0.011||||||Any movement|Fisher' Freeman Halton|||||||.011
73961439|NCT03887650|147459407|SUPERIORITY|||||||0.536||||||Full movement|Fishers Freeman Halton|||||||.536
73961440|NCT03887650|147459408|SUPERIORITY|||||||0.648||||||MME 0-24|Wilcoxon (Mann-Whitney)|||||||.648
73961441|NCT03887650|147459408|SUPERIORITY|||||||0.285||||||MME24-48|Wilcoxon (Mann-Whitney)|||||||.285
74023808|NCT01381094|147600242|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
74023809|NCT01381094|147600243|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
73961442|NCT03887650|147459408|SUPERIORITY|||||||0.122||||||MME48-72|Wilcoxon (Mann-Whitney)|||||||.122
73961443|NCT03887650|147459408|SUPERIORITY|||||||0.367||||||MME 72-120|Wilcoxon (Mann-Whitney)|||||||.367
73961444|NCT02601170|147459409|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73961445|NCT00028093|147459443|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in the outcome between the two groups||||0.54
73961446|NCT02582593|147459449|SUPERIORITY||Cohen's D|0.27||||0.575|TWO_SIDED|||||t = .581, only 1 comparison (2 groups) and thus multiple comparison correction not needed|t-test, 2 sided|||An independent sample t-test was used to examine difference in Pre-post intervention change scores for the Active and Sham groups;. Cohen's d was calculated to determine effect size.||||.575
73961447|NCT02582593|147459450|SUPERIORITY||Cohen's D|1.06||||0.16|TWO_SIDED|||||t = 1.574; only two comparisons, thus not necessary to adjust|t-test, 2 sided|||independent t-test, cohen's d effect size||||.160
73961448|NCT02582593|147459451|SUPERIORITY||Cohen's D|0.27||||0.424|TWO_SIDED||||||t-test, 2 sided|||independent t-test, Cohen's d effect size||||.424
73961449|NCT02582593|147459452|SUPERIORITY||Cohen's D|-1.03||||0.099|TWO_SIDED|||||no adjustment necessary, only 1 comparison|t-test, 2 sided|||independent sample t-test, Cohen's d effect size||||0.099
73961450|NCT02189252|147459464|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|160.05||||0.2702|TWO_SIDED|95.0|64.71|395.82||The closed sequential testing procedure stopped at this step as the P Value is greater than 0.05.|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the first test in the fixed testing sequence.||395.82|64.71|0.2702
73961451|NCT02189252|147459464|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|121.61||||0.6367|TWO_SIDED|95.0|49.17|300.76||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the second test in the fixed testing sequence.||300.76|49.17|0.6367
73961452|NCT02189252|147459465|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|193.91||||0.0511|TWO_SIDED|95.0|99.61|377.47||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the third test in the fixed testing sequence.||377.47|99.61|0.0511
73961453|NCT02189252|147459465|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|133.32||||0.3543|TWO_SIDED|95.0|68.49|259.52||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the fourth test in the fixed testing sequence.||259.52|68.49|0.3543
73961454|NCT02189252|147459466|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|259.19||||0.021|TWO_SIDED|95.0|119.75|560.99|||Mixed Models Analysis|||||560.99|119.75|0.0210
73961455|NCT02189252|147459466|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|177.95||||0.1256|TWO_SIDED|95.0|82.22|385.16|||Mixed Models Analysis|||||385.16|82.22|0.1256
73961456|NCT02189252|147459467|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|298.91||||0.0025|TWO_SIDED|95.0|164.32|543.74||The p-value was only interpreted descriptively|Mixed Models Analysis|||||543.74|164.32|0.0025
73961457|NCT02189252|147459467|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|187.28||||0.0418|TWO_SIDED|95.0|102.95|340.66||The p-value was only interpreted descriptively|Mixed Models Analysis|||||340.66|102.95|0.0418
73961458|NCT02189252|147459468|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|79.36||||0.6833|TWO_SIDED|95.0|22.95|274.45|||Mixed Models Analysis|||||274.45|22.95|0.6833
73961459|NCT02189252|147459468|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|69.39||||0.522|TWO_SIDED|95.0|20.07|239.98|||Mixed Models Analysis|||||239.98|20.07|0.5220
73961460|NCT02189252|147459469|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|104.78||||0.9034|TWO_SIDED|95.0|44.92|244.41|||Mixed Models Analysis|||||244.41|44.92|0.9034
73961461|NCT02189252|147459469|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|80.58||||0.5782||95.0|34.55|187.95|||Mixed Models Analysis|||||187.95|34.55|0.5782
73961462|NCT02189252|147459470|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|753.75||||0.0391|TWO_SIDED|95.0|112.03|5071.6|||Mixed Models Analysis|||||5071.6|112.03|0.0391
73961463|NCT02189252|147459470|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|104.98||||0.9578|TWO_SIDED|95.0|15.6|706.33|||Mixed Models Analysis|||||706.33|15.60|0.9578
73961464|NCT02189252|147459471|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|376.64||||0.0186|TWO_SIDED|95.0|128.55|1103.5|||Mixed Models Analysis|||||1103.5|128.55|0.0186
73961465|NCT02189252|147459471|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|131.74||||0.5955|TWO_SIDED|95.0|44.97|386.0|||Mixed Models Analysis|||||386.00|44.97|0.5955
74023810|NCT01381094|147600243|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0004
74023811|NCT01381094|147600243|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
73961466|NCT01391832|147459477|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 1-month follow-up.|t-value on group differences in change|-1.51|||>|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||>0.05
73961467|NCT01391832|147459477|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 3-month follow-up.|t-value on group differences in change|-2.05|||<|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||<0.05
73961468|NCT01391832|147459477|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 6-month follow-up.|t-value on group differences in change|-2.01|||<|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||<0.05
73961469|NCT01391832|147459478|SUPERIORITY||Mean Difference (Final Values)|-0.666|STANDARD_DEVIATION|0.7101||0.3422|TWO_SIDED|1.422|-0.7548|2.088||It is not adjusted for multiple comparisons.|t-test, 2 sided|degrees of freedom = 58|mean change from baseline to 6-month follow-up, rTMS Active - rTMS Sham|Null hypothesis test of differences in N2 micro-volt change from baseline to 6-month followup.||2.088|-0.7548|.3422
73961470|NCT01391832|147459478|OTHER|The analysis examined correlations in change in N2 and PTSD symptoms.|Slope|-0.3||||0.02|TWO_SIDED|||||Not adjusted|Regression, Linear|||The analysis examined the association between change in PTSD symptoms from baseline to 6-month follow-up and the change in N2 amplitude to the threatening stimulus from baseline to 6-month follow-up.|Correlations for the individual groups were active rTMS r(28)=-.373 and sham rTMS r(32)=-.296.|||0.02
74023812|NCT01381094|147600243|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
73849798|NCT02628444|147245315|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.871|||||TWO_SIDED|98.75|0.673|1.13||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 2||1.13|0.673|
73849799|NCT02628444|147245315|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|1.15|||||TWO_SIDED|98.75|0.887|1.49||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 3||1.49|0.887|
73849800|NCT02628444|147245315|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.655|||||TWO_SIDED|98.75|0.471|0.911||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 4||0.911|0.471|
73849801|NCT02628444|147245316|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.889|||||TWO_SIDED|98.75|0.462|1.71||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 1||1.71|0.462|
73961471|NCT01154985|147459479|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Cochran-Armitage trend test|||Proportion of responders in the EPA-E 1800 mg and 2700 mg groups compared to the proportion of responders in the placebo group compared using the Cochran-Armitage trend test in the Efficacy Evaluable analysis set. P-value less than 5% 1-sided. A total sample size of 210 (70 per arm) was planned to give 80% power for detecting a positive dose-response slope among the 3 treatment arms at 12 months.||||0.57
74023813|NCT01381094|147600243|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
73849802|NCT02628444|147245316|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.677|||||TWO_SIDED|98.75|0.402|1.14||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 2||1.14|0.402|
74023814|NCT01381094|147600244|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
74023815|NCT01381094|147600244|SUPERIORITY||||||=|0.0043|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0043
74023816|NCT01381094|147600244|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
74023817|NCT01381094|147600244|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
74023818|NCT01381094|147600244|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0001
74023819|NCT01381094|147600245|SUPERIORITY||||||=|0.0027|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0027
74023820|NCT01381094|147600245|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
74023821|NCT01381094|147600245|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0001
74023822|NCT01381094|147600245|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
73961472|NCT01154985|147459480|SUPERIORITY_OR_OTHER|||||||0.0137|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||||0.0137
74023823|NCT01381094|147600245|SUPERIORITY||||||=|0.0005|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0005
73961473|NCT01154985|147459480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2|||||TWO_SIDED|95.0|3.4|29.1||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||29.1|3.4|
74023824|NCT01381094|147600251|SUPERIORITY||||||=|0.6051|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6051
74023825|NCT01381094|147600251|SUPERIORITY||||||=|0.5197|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5197
74023826|NCT01381094|147600251|SUPERIORITY||||||=|0.1073|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1073
74023827|NCT01381094|147600251|SUPERIORITY||||||=|0.1321|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1321
74023828|NCT01381094|147600251|SUPERIORITY||||||=|0.4358|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.4358
74023829|NCT01381094|147600251|SUPERIORITY||||||=|0.8109|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8109
74023830|NCT01381094|147600251|SUPERIORITY||||||=|0.2575|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2575
74023831|NCT01381094|147600251|SUPERIORITY||||||=|0.8361|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8361
74023832|NCT01381094|147600251|SUPERIORITY||||||=|0.0294|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0294
74023833|NCT01381094|147600251|SUPERIORITY||||||=|0.8809|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8809
73961474|NCT01154985|147459480|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||||0.0006
73961475|NCT01154985|147459480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.0|||||TWO_SIDED|95.0|9.6|34.4||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||34.4|9.6|
73961476|NCT01154985|147459481|SUPERIORITY_OR_OTHER|||||||0.1592|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||||0.1592
73961477|NCT01154985|147459481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||||TWO_SIDED|95.0|-3.8|23.0||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||23.0|-3.8|
73961478|NCT01154985|147459481|SUPERIORITY_OR_OTHER|||||||0.0153|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||||0.0153
73961479|NCT01154985|147459481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|3.1|28.9||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||28.9|3.1|
73849803|NCT02628444|147245316|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.911|||||TWO_SIDED|98.75|0.573|1.45||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 3||1.45|0.573|
73849804|NCT02628444|147245316|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.702|||||TWO_SIDED|98.75|0.447|1.1||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 4||1.10|0.447|
73961480|NCT00566735|147459487|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|Degrees of freedom = 28||Independent t-test to assess differences between the placebo and galantamine groups in regard to pre- and post-ECT scores on the Delayed Memory Index (DMI).||||<0.05
73961481|NCT00722046|147459521|SUPERIORITY||Least Squares (LS) Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|3.04||0.6504|TWO_SIDED|90.0|-3.68|6.45|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||6.45|-3.68|0.6504
73961482|NCT00722046|147459521|SUPERIORITY||LS Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|3.13||0.5213|TWO_SIDED|90.0|-3.2|7.23|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||7.23|-3.20|0.5213
73849805|NCT02628444|147245317|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|1.05|||||TWO_SIDED|95.0|0.833|1.33||||||Group2/Group1: Serotype 1 (28 days after last vaccination)||1.33|0.833|
73961483|NCT00722046|147459521|SUPERIORITY||LS Mean Difference|2.27|STANDARD_ERROR_OF_MEAN|3.13||0.4698|TWO_SIDED|90.0|-2.94|7.48|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||7.48|-2.94|0.4698
73961484|NCT00722046|147459521|SUPERIORITY||LS Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.66||0.5183|TWO_SIDED|90.0|-2.71|6.17|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||6.17|-2.71|0.5183
73961485|NCT00722046|147459521|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|2.7||0.7529|TWO_SIDED|90.0|-3.65|5.35|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.35|-3.65|0.7529
73961486|NCT00722046|147459523|SUPERIORITY||LS Mean Difference|-4.07|STANDARD_ERROR_OF_MEAN|5.59||0.4688|TWO_SIDED|90.0|-13.38|5.24|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.24|-13.38|0.4688
73961487|NCT00722046|147459523|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|5.64||0.9743|TWO_SIDED|90.0|-9.59|9.22|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||9.22|-9.59|0.9743
73961488|NCT00722046|147459523|SUPERIORITY||LS Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|5.65||0.8824|TWO_SIDED|90.0|-8.57|10.25|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||10.25|-8.57|0.8824
73961489|NCT00722046|147459523|SUPERIORITY||LS Mean Difference|-4.09|STANDARD_ERROR_OF_MEAN|5.81||0.4831|TWO_SIDED|90.0|-13.77|5.58|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.58|-13.77|0.4831
73961490|NCT00722046|147459523|SUPERIORITY||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|5.88||0.9562|TWO_SIDED|90.0|-9.48|10.13|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||10.13|-9.48|0.9562
73961491|NCT00925587|147459534|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin -0.5 g/dL|Mean Difference (Final Values)|-0.188|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.427|0.052|||||Darbepoetin alfa QM - Darbepoetin alfa Q2W|Power = 90% at sample size calculation||0.052|-0.427|
73961492|NCT02164240|147459591|OTHER||Clinical Benefit Rate|0.0|||||TWO_SIDED|95.0|0.0|24.7||descriptive statistics only||||Clinical benefit rate of at least 30% at 16 weeks for the entire, combined population, was considered worthy of further study.||24.7|0|
73961493|NCT00373386|147459619|SUPERIORITY_OR_OTHER|||||||0.644|||||||t-test, 2 sided|||compared with baseline||||0.644
73961494|NCT00373386|147459620|SUPERIORITY_OR_OTHER|||||||0.018||||||Versus baseline|t-test, 2 sided|paired||Compared with baseline||||0.018
73961495|NCT00373386|147459621|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Comparison to baseline||||0.04
73961496|NCT00373386|147459622|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Comparison with baseline||||0.004
73961497|NCT00373386|147459623|SUPERIORITY_OR_OTHER|||||||0.804|||||||t-test, 2 sided|||Comparison with baseline||||0.804
73961498|NCT00373386|147459624|SUPERIORITY_OR_OTHER|||||||0.095|||||||t-test, 2 sided|||Comparison with baseline||||0.095
73961499|NCT00373386|147459625|SUPERIORITY_OR_OTHER|||||||0.648|||||||t-test, 2 sided|||Comparison with baseline||||0.648
73961500|NCT01925469|147459646|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Differences in the median change in pain scores were assessed using Wilcoxon rank sum test.||An a priori sample size calculation determined at least 28 patients were needed to detect a clinically significant 13 mm difference in pain score (α=0.05, power =0.80) with a standard deviation of 12 mm. Intention to treat analysis was performed.||||0.43
73961501|NCT01925469|147459647|SUPERIORITY_OR_OTHER|||||||0.4|||||||Fisher Exact|||Fisher exact test was used to assess differences in satisfaction scores by treatment group. Correlation between pain and satisfaction scores was assessed by Spearman's correlation coefficient.||||0.4
73961502|NCT01925469|147459648|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
73849806|NCT02628444|147245317|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.821|1.19||||||Group2/Group1: Serotype 2 (28 days after last vaccination)||1.19|0.821|
73849807|NCT02628444|147245317|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.972|||||TWO_SIDED|95.0|0.81|1.17||||||Group2/Group1: Serotype 3 (28 days after last vaccination)||1.17|0.810|
73849808|NCT02628444|147245317|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.963|||||TWO_SIDED|95.0|0.814|1.14||||||Group2/Group1: Serotype 4 (28 days after last vaccination)||1.14|0.814|
73849809|NCT02628444|147245317|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.762|1.39||||||Group2/Group1: Serotype 1 (1 year after last vaccination)||1.39|0.762|
74023834|NCT01381094|147600251|SUPERIORITY||||||=|0.4971|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4971
73849810|NCT02628444|147245317|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.917|||||TWO_SIDED|95.0|0.724|1.16||||||Group2/Group1: Serotype 2 (1 year after last vaccination)||1.16|0.724|
73849811|NCT02628444|147245317|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.933|||||TWO_SIDED|95.0|0.742|1.17||||||Group2/Group1: Serotype 3 (1 year after last vaccination)||1.17|0.742|
73849812|NCT02628444|147245317|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.916|||||TWO_SIDED|95.0|0.75|1.12||||||Group2/Group1: Serotype 4 (1 year after last vaccination)||1.12|0.750|
73849813|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.029|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 5.||||=0.029
73849814|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.027|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 11.||||=0.027
73961503|NCT01308567|147459651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.7574|TWO_SIDED|95.0|0.819|1.16||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by Eastern Cooperative Oncology Group performance status (ECOG PS) score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.16|0.819|0.7574
73961504|NCT01308567|147459651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.009||||0.9967|TWO_SIDED|95.0|0.85|1.197||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.197|0.85|0.9967
73849815|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.602|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at end of FU.||||=0.602
73849816|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.631|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 5.||||=0.631
73849817|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.339|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 11.||||=0.339
73849818|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.44|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at end of FU.||||=0.440
73961505|NCT01308567|147459652|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.989|||||TWO_SIDED|95.0|0.849|1.152|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.152|0.849|
73849819|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 5.||||=1.000
73849820|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.465|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 11.||||=0.465
73849821|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.431|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at end of FU.||||=0.431
73849822|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.65|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 5.||||=0.650
73849823|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.98|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 11.||||=0.980
73849824|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.906|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at end of FU.||||=0.906
73849825|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.381|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 5.||||=0.381
73849826|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.886|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 11.||||=0.886
73849827|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.264|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at end of FU.||||=0.264
73849828|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.424|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 5.||||=0.424
73849829|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 11.||||=1.000
73849830|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.312|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at end of FU.||||=0.312
73849831|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.664|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue statistical analysis at Cycle 5.||||=0.664
73849832|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.17|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue functioning statistical analysis at Cycle 11.||||=0.170
73849833|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.318|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue statistical analysis at end of FU.||||=0.318
74023835|NCT01381094|147600251|SUPERIORITY||||||=|0.3994|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3994
74023836|NCT01381094|147600251|SUPERIORITY||||||=|0.5022|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5022
73849834|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.536|TWO_SIDED||||||t-test, 2 sided|||CFB in Nausea/vomiting statistical analysis at Cycle 5.||||=0.536
73849835|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.9|TWO_SIDED||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at Cycle 11.||||=0.900
73849836|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.188|TWO_SIDED||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at end of FU.||||=0.188
73849837|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.37|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 5.||||=0.370
73849838|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|0.813|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 11.||||=0.813
73849839|NCT00532129|147245352|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at end of FU.||||=1.000
73961506|NCT01308567|147459652|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.063|||||TWO_SIDED|95.0|0.913|1.236|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.236|0.913|
74023837|NCT01381094|147600251|SUPERIORITY||||||=|0.9916|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.9916
74023838|NCT01381094|147600251|SUPERIORITY||||||=|0.2292|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.2292
73849840|NCT04551898|147245392|SUPERIORITY||Least square Mean|-0.25||||0.4829|TWO_SIDED|90.0|-0.84|0.34|||Mixed Models Analysis|||||0.34|-0.84|0.4829
73849841|NCT04551898|147245392|SUPERIORITY||Least square Mean|-0.51||||0.1739|TWO_SIDED|90.0|-1.13|0.11|||Mixed Models Analysis|||||0.11|-1.13|0.1739
73849842|NCT04551898|147245392|SUPERIORITY||Least square Mean|0.19||||0.6006|TWO_SIDED|90.0|-0.4|0.77|||Mixed Models Analysis|||||0.77|-0.40|0.6006
73849843|NCT04551898|147245392|SUPERIORITY|||||||0.4996||||||H0: there is a flat dose response curve comparing change from baseline to Day 8 in viral load in the Placebo and other BGB-DXP593 dose groups|t-test, 1 sided|MCP Mod was used to test the primary hypothesis and provide 1-sided p-value accordingly.||||||0.4996
73849844|NCT03427814|147245408|SUPERIORITY||||||=|0.1428|||||||Log Rank|The one-sided p-value was based on a stratified log-rank test.||||||= 0.1428
73849845|NCT03846427|147245415|SUPERIORITY|P value was based on the exact binomial test against the null hypothesis of ORR = 30% with alternative of ORR \> 30%|||||<|0.0001|||||||Binomial exact method|||||||<0.0001
73849846|NCT04971967|147245447|SUPERIORITY|||||||0.07|||||||Generalized linear regression|||||||0.07
73849847|NCT04971967|147245448|SUPERIORITY|||||||0.3|||||||Generalized linear regression|||||||0.30
74023839|NCT01381094|147600251|SUPERIORITY||||||=|0.1331|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1331
73849848|NCT04971967|147245450|SUPERIORITY|||||||0.28|||||||Generalized linear regression|||||||0.28
73849849|NCT04971967|147245452|SUPERIORITY|||||||0.07|||||||Generalized linear regression|||||||0.07
73849850|NCT04971967|147245453|SUPERIORITY|||||||0.11|||||||Generalized linear regression|||||||0.11
73849851|NCT02820844|147245539|OTHER||Mean Difference (Net)|-2.16|||<|0.001|TWO_SIDED|95.0|-3.14|-1.18||Analysis was performed using mixed-model for repeated measures (MMRM) with treatment, site, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.|||-1.18|-3.14|<0.001
73849852|NCT02820844|147245540|OTHER||Mean Difference (Net)|29.69|||<|0.001|TWO_SIDED|95.0|18.47|40.91||Analysis performed using MMRM, with treatment, site, visit, Baseline urinary urgency incontinence (UUI) episodes over 3 day diary (\<=9 or \>=10), treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.|||40.91|18.47|<0.001
73849853|NCT02820844|147245595|OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10).|Log Rank||Hazard ratio and 95% Confidence Interval (CI) are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10) as fixed effect.|||0.60|0.34|<0.001
73849854|NCT02820844|147245596|OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.66||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10)|Log Rank||Hazard ratio and 95% CI are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10) as fixed effect.|||0.66|0.38|<0.001
73849855|NCT02266147|147245676|OTHER|MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.||||||||||||||||MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.|MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.|||
74023840|NCT01381094|147600251|SUPERIORITY||||||=|0.5518|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5518
73961507|NCT01308567|147459653|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958|||||TWO_SIDED|95.0|0.785|1.17|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.17|0.785|
73961508|NCT01308567|147459653|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.916|||||TWO_SIDED|95.0|0.75|1.118|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.118|0.75|
73961509|NCT01308567|147459655|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.948|||||TWO_SIDED|95.0|0.8|1.123|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.123|0.8|
73961510|NCT01308567|147459655|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047|||||TWO_SIDED|95.0|0.886|1.238|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.238|0.886|
73961511|NCT01308567|147459657|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.986|1.434|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.434|0.986|
73961512|NCT01308567|147459657|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.985|1.435|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.435|0.985|
73961513|NCT01308567|147459659|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.121|||||TWO_SIDED|95.0|0.886|1.417|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.417|0.886|
73961514|NCT01308567|147459659|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014|||||TWO_SIDED|95.0|0.798|1.288|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.288|0.798|
73961515|NCT01040689|147459672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.145|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.224|0.145|<0.0001
73961516|NCT01040689|147459672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.167|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.246|0.167|<0.0001
73961517|NCT01040689|147459672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.133|0.212|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.212|0.133|<0.0001
73961518|NCT01040689|147459673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.09|0.173|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.173|0.090|<0.0001
73961519|NCT01040689|147459673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.219|0.136|<0.0001
73961520|NCT01040689|147459673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.081|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.164|0.081|<0.0001
73961521|NCT01040689|147459674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.121|0.196|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.196|0.121|<0.0001
73961522|NCT01040689|147459674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.155|0.23|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.230|0.155|<0.0001
73961523|NCT01040689|147459674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.11|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.185|0.110|<0.0001
73961524|NCT01040689|147459675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.147|0.216|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.216|0.147|<0.0001
73961525|NCT01040689|147459675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.178|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.247|0.178|<0.0001
73961526|NCT01040689|147459675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.097|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.167|0.097|<0.0001
74023841|NCT01381094|147600251|SUPERIORITY||||||=|0.9032|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9032
73849856|NCT01896687|147245692|SUPERIORITY_OR_OTHER||||||<|0.001||||||"The worst pain and interference scores as dependent variables, and time (baseline, 1-, and 3 week follow up visit), group (Calmare or Sham), and group by time interaction terms as the independent variable."|ANOVA|||||||<0.001
73849857|NCT02831855|147245735|NON_INFERIORITY|Non-inferiority (NI) of Tofacitinib 11 mg + Methotrexate Placebo to Tofacitinib 11 mg + continued Methotrexate was concluded if the upper bound of 95% 2-sided confidence interval (CI) for difference between the 2 arms (Tofacitinib 11 mg + Methotrexate Placebo reporting arm - Tofacitinib 11 mg + continued Methotrexate arm) was lower than 0.6.|Least Square (LS) Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|0.12|0.48||The p-value is one-sided for the test against the NI margin of 0.6.|MMRM|||Linear mixed-effect model of repeated measures (MMRM) was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (bDMARD), and baseline DAS28-4 (ESR) value as a covariate.||0.48|0.12|0.0005
73849858|NCT02831855|147245736|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.03|0.41||||||Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (ESR) value as a covariate.||0.41|0.03|
73849859|NCT02831855|147245737|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.08|0.43||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.||0.43|0.08|
73849860|NCT02831855|147245737|SUPERIORITY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.11|0.45||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.||0.45|0.11|
73961527|NCT01040689|147459676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.17|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.243|0.170|<0.0001
73849861|NCT02831855|147245738|SUPERIORITY||LS Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|0.4|3.07||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.||3.07|0.40|
73849862|NCT02831855|147245738|SUPERIORITY||LS Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|0.83|3.43||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.||3.43|0.83|
73849863|NCT02831855|147245739|SUPERIORITY||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|0.53|3.37||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.||3.37|0.53|
73961528|NCT01040689|147459676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.179|0.252|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.252|0.179|<0.0001
73849864|NCT02831855|147245739|SUPERIORITY||LS Mean Difference|2.23|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.86|3.59||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.||3.59|0.86|
73849865|NCT02831855|147245740|SUPERIORITY||Difference in percentage of participants|-5.69|||||TWO_SIDED|95.0|-14.15|2.76||||||Week 36||2.76|-14.15|
73849866|NCT02831855|147245740|SUPERIORITY||Difference in percentage of participants|-4.54|||||TWO_SIDED|95.0|-13.04|3.94||||||Week 48||3.94|-13.04|
73849867|NCT02831855|147245741|SUPERIORITY||Difference in percentage of participants|-5.14|||||TWO_SIDED|95.0|-13.07|2.77||||||Week 36||2.77|-13.07|
73849868|NCT02831855|147245741|SUPERIORITY||Difference in percentage of participants|-8.52|||||TWO_SIDED|95.0|-16.28|-0.76||||||Week 48||-0.76|-16.28|
73849869|NCT02831855|147245742|SUPERIORITY||Difference in percentage of participants|-7.39|||||TWO_SIDED|95.0|-15.17|0.38||||||Week 36||0.38|-15.17|
73849870|NCT02831855|147245742|SUPERIORITY||Difference in percentage of participants|-11.91|||||TWO_SIDED|95.0|-19.56|-4.26||||||Week 48||-4.26|-19.56|
74023842|NCT01381094|147600251|SUPERIORITY||||||=|0.2387|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2387
73849871|NCT02831855|147245743|SUPERIORITY||Difference in percentage of participants|-7.02|||||TWO_SIDED|95.0|-14.81|0.77||||||Week 36||0.77|-14.81|
73849872|NCT02831855|147245743|SUPERIORITY||Difference in percentage of participants|-10.02|||||TWO_SIDED|95.0|-17.68|-2.37||||||Week 48||-2.37|-17.68|
73849873|NCT02831855|147245744|SUPERIORITY||Difference in percentage of participants|-8.52|||||TWO_SIDED|95.0|-15.27|-1.78||||||Week 36||-1.78|-15.27|
73849874|NCT02831855|147245744|SUPERIORITY||Difference in percentage of participants|-1.33|||||TWO_SIDED|95.0|-8.5|5.83|||Two Sided|||Week 48||5.83|-8.50|
73849875|NCT02831855|147245745|SUPERIORITY||Difference in percentage of participants|-8.11|||||TWO_SIDED|95.0|-15.4|-0.82||||||Week 36||-0.82|-15.40|
73849876|NCT02831855|147245745|SUPERIORITY||Difference in percentage of participants|-6.21|||||TWO_SIDED|95.0|-13.74|1.32||||||Week 48||1.32|-13.74|
73849877|NCT02831855|147245746|SUPERIORITY||Difference in percentage of participants|-5.63|||||TWO_SIDED|95.0|-14.12|2.84||||||Week 36||2.84|-14.12|
73849878|NCT02831855|147245746|SUPERIORITY||Difference in percentage of participants|-4.13|||||TWO_SIDED|95.0|-12.62|4.36||||||Week 48||4.36|-12.62|
73849879|NCT02831855|147245747|SUPERIORITY||Difference in percentage of participants|-8.84|||||TWO_SIDED|95.0|-16.44|-1.24||||||Week 36||-1.24|-16.44|
73849880|NCT02831855|147245747|SUPERIORITY||Difference in percentage of participants|-2.41|||||TWO_SIDED|95.0|-10.18|5.35||||||Week 48||5.35|-10.18|
73961529|NCT01040689|147459676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.146|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.219|0.146|<0.0001
73961530|NCT01040689|147459677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.177|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.249|0.177|<0.0001
73961531|NCT01040689|147459677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.203|0.275|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.275|0.203|<0.0001
73961532|NCT01040689|147459677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.125|0.197|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.197|0.125|<0.0001
73961533|NCT01040689|147459678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.168|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.258|0.168|<0.0001
73961534|NCT01040689|147459678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.189|0.279|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.279|0.189|<0.0001
73961535|NCT01040689|147459678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.156|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.246|0.156|<0.0001
73961536|NCT01040689|147459679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.096|0.17|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.170|0.096|<0.0001
73961537|NCT01040689|147459679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.11|0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.184|0.110|<0.0001
73961538|NCT01040689|147459679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.06|0.134|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.134|0.060|<0.0001
73961539|NCT01040689|147459680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.216|0.348|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.348|0.216|<0.0001
73961540|NCT01040689|147459680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.303|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.237|0.368|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.368|0.237|<0.0001
73961541|NCT01040689|147459680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.21|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.342|0.210|<0.0001
73961542|NCT01040689|147459681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.131|0.262|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.262|0.131|<0.0001
73961543|NCT01040689|147459681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.187|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.318|0.187|<0.0001
73961544|NCT01040689|147459681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.118|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.249|0.118|<0.0001
73961545|NCT01040689|147459682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.178|0.301|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.301|0.178|<0.0001
73961546|NCT01040689|147459682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.216|0.339|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.339|0.216|<0.0001
73849881|NCT02831855|147245748|SUPERIORITY||Difference in percentage of participants|-8.85|||||TWO_SIDED|95.0|-16.38|-1.31||||||Week 36||-1.31|-16.38|
73849882|NCT02831855|147245748|SUPERIORITY||Difference in percentage of participants|-3.16|||||TWO_SIDED|95.0|-10.99|4.65||||||Week 48||4.65|-10.99|
73849883|NCT02831855|147245749|SUPERIORITY||Difference in percentage of participants|-6.96|||||TWO_SIDED|95.0|-14.06|0.14||||||Week 36||0.14|-14.06|
73849884|NCT02831855|147245749|SUPERIORITY||Difference in percentage of participants|-6.59|||||TWO_SIDED|95.0|-13.8|0.61||||||Week 48||0.61|-13.80|
73849885|NCT02831855|147245750|SUPERIORITY||Difference in percentage of participants|-12.75|||||TWO_SIDED|95.0|-21.01|-4.48||||||Week 36||-4.48|-21.01|
73849886|NCT02831855|147245750|SUPERIORITY||Difference in percentage of participants|-11.99|||||TWO_SIDED|95.0|-20.22|-3.75||||||Week 48||-3.75|-20.22|
73849887|NCT02831855|147245751|SUPERIORITY||Difference in percentage of participants|-5.37|||||TWO_SIDED|95.0|-13.63|2.89||||||Week 36||2.89|-13.63|
73849888|NCT02831855|147245751|SUPERIORITY||Difference in percentage of participants|-4.97|||||TWO_SIDED|95.0|-13.32|3.36||||||Week 48||3.36|-13.32|
73849889|NCT02831855|147245752|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|0.02|0.16||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.||0.16|0.02|
73849890|NCT02831855|147245752|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.06|0.09||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.||0.09|-0.06|
73849891|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.79|0.92||||||Change at Week 36: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.||0.92|-1.79|
73849892|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-0.82|1.85||||||Change at Week 48: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.||1.85|-0.82|
73849893|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.97|-0.37||||||Change at Week 36: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.||-0.37|-2.97|
73849894|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.13|0.66||||||Change at Week 48: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.||0.66|-2.13|
73849895|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.5|1.21||||||Change at Week 36: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.||1.21|-1.50|
73849896|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.95|0.93||||||Change at Week 48: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.||0.93|-1.95|
73849897|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.9|-0.01||||||Change at Week 36: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.||-0.01|-2.90|
73849898|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.23|0.73||||||Change at Week 48: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.||0.73|-2.23|
73849899|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-2.29|0.49||||||Change at Week 36: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.||0.49|-2.29|
73849900|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-1.94|1.02||||||Change at Week 48: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.||1.02|-1.94|
73849901|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-2.64|0.43||||||Change at Week 36: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.||0.43|-2.64|
73961547|NCT01040689|147459682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.168|0.291|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.291|0.168|<0.0001
73961548|NCT01040689|147459683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.207|0.33|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.330|0.207|<0.0001
73961549|NCT01040689|147459683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.312|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.251|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.374|0.251|<0.0001
73961550|NCT01040689|147459683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.153|0.277|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.277|0.153|<0.0001
73961551|NCT01040689|147459684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.246|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.388|0.246|<0.0001
73961552|NCT01040689|147459684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.247|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.388|0.247|<0.0001
74023843|NCT01381094|147600251|SUPERIORITY||||||=|0.4251|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.4251
73961553|NCT01040689|147459684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.231|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.373|0.231|<0.0001
73961554|NCT01040689|147459685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.222|0.378|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.378|0.222|<0.0001
73961555|NCT01040689|147459685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.22|0.375|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.375|0.220|<0.0001
74023844|NCT01381094|147600252|SUPERIORITY||||||=|0.0448|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0448
73849902|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-1.95|1.01||||||Change at Week 48: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.||1.01|-1.95|
73849903|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.52|0.22||||||Change at Week 36: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.||0.22|-2.52|
73849904|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.94|0.91||||||Change at Week 48: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.||0.91|-1.94|
73849905|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.3|1.08||||||Change at Week 36: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.||1.08|-1.30|
73849906|NCT02831855|147245753|SUPERIORITY||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-0.6|1.83||||||Change at Week 48: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.||1.83|-0.60|
73961556|NCT01040689|147459685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.295|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.217|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.373|0.217|<0.0001
73961557|NCT01040689|147459686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.115|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.255|0.115|<0.0001
73961558|NCT01040689|147459686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.143|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.143|<0.0001
73961559|NCT01040689|147459686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.036||0.0003||95.0|0.059|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.199|0.059|0.0003
73961560|NCT01185561|147459688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.89|STANDARD_ERROR_OF_MEAN|2.43||0.001|TWO_SIDED|95.0|4.03|13.76|||t-test, 2 sided|||The null hypothesis is that there is no difference in CES-D score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||13.76|4.03|.001
73961561|NCT01185561|147459689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.82|STANDARD_ERROR_OF_MEAN|3.27||0.02|TWO_SIDED|95.0|1.29|14.37|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||14.37|1.29|.02
73961562|NCT01185561|147459690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48|STANDARD_ERROR_OF_MEAN|2.91||0.005|TWO_SIDED|95.0|2.64|14.31|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||14.31|2.64|.005
73961563|NCT01185561|147459691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|3.75||0.85|TWO_SIDED|95.0|-6.77|8.24|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anger Expression Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||8.24|-6.77|.85
73961564|NCT00364013|147459717|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-2.27||||0.0234||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Wild-type KRAS Efficacy Analysis Set was compared at a significance level of 5%.||||0.0234
73961565|NCT00364013|147459717|SUPERIORITY_OR_OTHER_LEGACY||Normal score|2.28||||0.0227||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Mutant KRAS Efficacy Analysis Set was compared at a significance level of 5% conditional on first demonstrating a significant treatment effect in PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.0227
73961566|NCT00364013|147459718|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.8||||0.0723||||||cP-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the wild-type KRAS Efficacy Analysis Set was performed at a significance level of 4.99% conditional on a statistically significant difference for PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.0723
73961567|NCT00364013|147459718|SUPERIORITY_OR_OTHER_LEGACY||Normal score|1.83||||0.0678||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the mutant KRAS Efficacy Analysis Set was performed at an significance level of 4.99% conditional on a statistically significant difference for PFS in the Mutant KRAS Efficacy Analysis Set.||||0.0678
74023845|NCT01381094|147600252|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0004
74023846|NCT01381094|147600252|SUPERIORITY||||||=|0.0813|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0813
74023847|NCT01381094|147600252|SUPERIORITY||||||=|0.0038|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0038
73849907|NCT02831855|147245754|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.01|0.37||||||Change at Week 36: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score- as a covariate.||0.37|-2.01|
73849908|NCT02831855|147245754|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.11|1.29||||||Change at Week 48: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (DMARD), and baseline SF-36 physical component score- as a covariate.||1.29|-1.11|
73849909|NCT02831855|147245754|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.13|0.49||||||Change at Week 36: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.||0.49|-2.13|
73961568|NCT00364013|147459719|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.35||||0.0684|TWO_SIDED|95.0|0.98|1.87|||Stratified exact test|Adjusted for geographic region and ECOG score.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.|||1.87|0.98|0.0684
73961569|NCT00364013|147459719|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.9822|TWO_SIDED|95.0|0.65|1.47|||Stratified exact test|Adjusted for geographic region and ECOG score|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.|||1.47|0.65|0.9822
74023848|NCT01381094|147600252|SUPERIORITY||||||=|0.6861|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6861
73849910|NCT02831855|147245754|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.06|0.7||||||Change at Week 48: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.||0.70|-2.06|
73961570|NCT05714696|147459761|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||.007
73961571|NCT05714696|147459762|SUPERIORITY|||||||0.049|||||||t-test, 2 sided|||||||.049
73961572|NCT05714696|147459763|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||.029
73961573|NCT05714696|147459764|SUPERIORITY|||||||0.163|||||||t-test, 2 sided|||||||.163
74023849|NCT01381094|147600252|SUPERIORITY||||||=|0.0553|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0553
73849911|NCT02831855|147245755|SUPERIORITY||LS Mean Difference|1.61|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|-3.14|6.37||||||Change at Week 36: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.||6.37|-3.14|
73961574|NCT05714696|147459765|SUPERIORITY|||||||0.442|||||||t-test, 2 sided|||||||.442
73961575|NCT05714696|147459767|SUPERIORITY|||||||0.527|||||||t-test, 2 sided|||||||.527
73961576|NCT05714696|147459768|SUPERIORITY|||||||0.311|||||||t-test, 2 sided|||||||.311
73961577|NCT05714696|147459769|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
73961578|NCT05714696|147459770|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||.005
74023850|NCT01381094|147600252|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0004
74023851|NCT01381094|147600252|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
74023852|NCT01381094|147600252|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
74023853|NCT01381094|147600252|SUPERIORITY||||||=|0.7379|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7379
74023854|NCT01381094|147600252|SUPERIORITY||||||=|0.072|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0720
74023855|NCT01381094|147600252|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0002
74023856|NCT01381094|147600252|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
74023857|NCT01381094|147600252|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
74023858|NCT01381094|147600252|SUPERIORITY||||||=|0.6781|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.6781
74023859|NCT01381094|147600252|SUPERIORITY||||||=|0.0524|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0524
73849912|NCT02831855|147245755|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-5.01|3.99||||||Change at Week 48: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.||3.99|-5.01|
74023860|NCT01381094|147600252|SUPERIORITY||||||=|0.0367|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0367
74023861|NCT01381094|147600252|SUPERIORITY||||||=|0.6671|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6671
74023862|NCT01381094|147600252|SUPERIORITY||||||=|0.6861|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6861
74023863|NCT01381094|147600252|SUPERIORITY||||||=|0.9012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9012
74023864|NCT01381094|147600253|SUPERIORITY||||||=|0.3953|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.3953
74023865|NCT01381094|147600253|SUPERIORITY||||||=|0.085|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0850
74023866|NCT01381094|147600253|SUPERIORITY||||||=|0.6045|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6045
74023867|NCT01381094|147600253|SUPERIORITY||||||=|0.7743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7743
74023868|NCT01381094|147600253|SUPERIORITY||||||=|0.5326|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5326
73849913|NCT02831855|147245755|SUPERIORITY||LS Mean Difference|3.19|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-0.51|6.89||||||Change at Week 36: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.||6.89|-0.51|
73961579|NCT00696618|147459773|SUPERIORITY_OR_OTHER||||||<|0.05||||||Adjusted for multiple comparisons.|multi-level|||Nine research participants provided the ability to detect an effect size of 1.25 standard deviation units relative to the mean with 80% power using two-sided, 5% alpha in a paired analysis. The Baseline condition (no intervention) was assigned a value of 1 and geometric mean ratios with 95% confidence intervals for each intervention were calculated relative to baseline.||||<.05
73961580|NCT00696618|147459774|SUPERIORITY_OR_OTHER||||||<|0.05|||||||multi-level|||||||<.05
73961581|NCT00696618|147459775|SUPERIORITY_OR_OTHER||||||<|0.05|||||||mulit-level analysis|||||||<.05
73961582|NCT01199705|147459785|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||1.39||||||||1.390||
73961583|NCT01199705|147459785|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.953||||||||0.953||
73961584|NCT01199705|147459785|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.914||||||||0.914||
73961585|NCT01199705|147459787|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||1.204||||||||1.204||
73961586|NCT01199705|147459787|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.834||||||||0.834||
73961587|NCT01199705|147459787|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.802||||||||0.802||
73961588|NCT01415349|147459792|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|0.966|1.09|||Mixed Models Analysis|||||1.09|0.966|
74023869|NCT01381094|147600253|SUPERIORITY||||||=|0.3465|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.3465
73961589|NCT01415349|147459793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.998|1.08|||Mixed Models Analysis|||||1.08|0.998|
73961590|NCT03473340|147459794|SUPERIORITY|||||||0.17697507|||||||t-test, 2 sided|||P-Value provided is for net change only.||||0.17697507
73961591|NCT03473340|147459795|SUPERIORITY|||||||0.77367872|||||||Welch Two Sample t-test|||P-Value provided is for net change only.||||0.77367872
73961592|NCT03473340|147459796|SUPERIORITY|||||||0.68595748|||||||t-test, 2 sided|||P-Value provided is for net change only.||||0.68595748
73961593|NCT03473340|147459797|SUPERIORITY|||||||0.00127634|||||||Fisher Exact|||||||0.00127634
73961594|NCT03473340|147459798|SUPERIORITY|||||||0.80904544|||||||Fisher Exact|||||||0.80904544
73961595|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.51 in the 11Pn Group and N= 203 and Adjusted GMC= 1.36 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.9|||||TWO_SIDED|95.9|0.75|1.07||||||ANTI-1 serotype test :to demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.07|0.75|
73961596|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.77 in the 11Pn Group and N= 203 and Adjusted GMC= 1.66 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||TWO_SIDED|95.9|0.77|1.14||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.14|0.77|
73961597|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 2.46 in the 11Pn Group and N= 201 and Adjusted GMC= 2.16 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.88|||||TWO_SIDED|95.9|0.75|1.03||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.03|0.75|
73961598|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =0.51 in the 11Pn Group and N= 200 and Adjusted GMC= 0.47 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.93|||||TWO_SIDED|95.9|0.71|1.23||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.23|0.71|
74023870|NCT01381094|147600253|SUPERIORITY||||||=|0.2756|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2756
74023871|NCT01381094|147600253|SUPERIORITY||||||=|0.1414|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.1414
74023872|NCT01381094|147600253|SUPERIORITY||||||=|0.6941|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.6941
74023873|NCT01381094|147600253|SUPERIORITY||||||=|0.9403|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.9403
74023874|NCT01381094|147600253|SUPERIORITY||||||=|0.831|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.8310
74023875|NCT01381094|147600253|SUPERIORITY||||||=|0.0654|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0654
74084728|NCT03653026|147722721|SUPERIORITY||Least Squares (LS) Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|24.98|37.36||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|||37.36|24.98|<0.001
73961599|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=219 and Adjusted GMC =2.30 in the 11Pn Group and N= 202 and Adjusted GMC= 2.17 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||TWO_SIDED|95.9|0.81|1.1||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.10|0.81|
73849914|NCT02831855|147245755|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-2.41|5.61||||||Change at Week 48: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.||5.61|-2.41|
73849915|NCT02831855|147245755|SUPERIORITY||LS Mean Difference|3.01|STANDARD_ERROR_OF_MEAN|2.97|||TWO_SIDED|95.0|-2.84|8.87||||||Change at Week 36: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.||8.87|-2.84|
73849916|NCT02831855|147245755|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-8.34|6.54||||||Change at Week 48: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.||6.54|-8.34|
73849917|NCT02831855|147245755|SUPERIORITY||LS Mean Difference|2.84|STANDARD_ERROR_OF_MEAN|3.45|||TWO_SIDED|95.0|-3.97|9.65||||||Change at Week 36: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.||9.65|-3.97|
73961600|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.56 in the 11Pn Group and N= 200 and Adjusted GMC= 1.40 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.89|||||TWO_SIDED|95.9|0.76|1.06||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.06|0.76|
73849918|NCT02831855|147245755|SUPERIORITY||LS Mean Difference|-2.46|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-10.72|5.8||||||Change at Week 48: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.||5.80|-10.72|
73849919|NCT02831855|147245756|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.07|-0.01||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.||-0.01|-0.07|
73849920|NCT02831855|147245756|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.06|0.01||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.||0.01|-0.06|
73849921|NCT02831855|147245757|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.37|1.0||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.||1.00|-1.37|
73961601|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 4.22 in the 11Pn Group and N= 201 and Adjusted GMC= 4.06 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.96|||||TWO_SIDED|95.9|0.81|1.15||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.15|0.81|
74023876|NCT01381094|147600253|SUPERIORITY||||||=|0.4169|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4169
73961602|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =2.81 in the 11Pn Group and N= 201 and Adjusted GMC= 2.57 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.92|||||TWO_SIDED|95.9|0.74|1.14||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.14|0.74|
73961603|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 3.70 in the 11Pn Group and N= 202 and Adjusted GMC= 3.68 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.0|||||TWO_SIDED|95.9|0.81|1.23||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.23|0.81|
73961604|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 0.62 in the 11Pn Group and N= 199 and Adjusted GMC= 0.71 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.15|||||TWO_SIDED|95.9|0.89|1.48||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.48|0.89|
73961605|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations/titres, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=217 and Adjusted GMC =1.61 in the 11Pn Group and N= 206 and Adjusted GMC= 2.75 for the Prevnar13 Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.71|||||TWO_SIDED|95.9|1.44|2.03||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||2.03|1.44|
73971025|NCT04119843|147482208|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|0.678|<|0.001|TWO_SIDED|95.0|0.638|0.985|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 3||0.985|0.638|<0.001
74023877|NCT01381094|147600253|SUPERIORITY||||||=|0.0103|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0103
74023878|NCT01381094|147600253|SUPERIORITY||||||=|0.3968|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3968
74023879|NCT01381094|147600253|SUPERIORITY||||||=|0.0325|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0325
73849922|NCT02831855|147245757|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.07|1.44||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.||1.44|-1.07|
73849923|NCT02831855|147245758|SUPERIORITY||Difference in percentage of participants|-10.02|STANDARD_ERROR_OF_MEAN|3.87|||TWO_SIDED|95.0|-17.61|-2.42||||||Week 36||-2.42|-17.61|
73849924|NCT02831855|147245758|SUPERIORITY||Difference in percentage of participants|-6.62|STANDARD_ERROR_OF_MEAN|3.89|||TWO_SIDED|95.0|-14.26|1.0||||||Week 48||1.00|-14.26|
73849925|NCT01803880|147245770|NON_INFERIORITY|"Non-inferiority Margin = 10 points. Non-inferiority of study device was concluded if lower limit of one-sided 97.5% CI for treatment difference \<10.~Superiority of study device was established if LS means of treatment difference and lower limit of one-sided 97.5% CI for treatment difference ≤0."|One-sided 97.5% confidence interval (CI)|-7.42|STANDARD_ERROR_OF_MEAN|5.137|>|0.05|ONE_SIDED|97.5|-19.29|||All unscheduled visits were to be included and nominal visits were to be applied using analysis visit windows. Both the assigned analysis visits and the site reported nominal visits were provided in the subject data listings.|ANCOVA|Due to early termination, all inferential analysis was interpreted as descriptive and carried out in an exploratory manner.||An ANCOVA model was used to compare the difference in the devices for change from Baseline in the KOOS at Week 52. KOOS was derived as the average of five subscale scores. LOCF imputation was considered for missing value. One-sided 97.5% confidence interval (CI) for treatment difference (Study-Control) was to be used for determining non-inferiority/superiority of the study device.|||-19.29|>0.05
73849926|NCT02041299|147245811|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 96.01% confidence interval (CI) is less than or equal to 2 mg/g dw.|Mean Difference (Net)|0.26||||0.0399|TWO_SIDED|96.01|-0.97|1.48|||ANCOVA|||||1.48|-0.97|0.0399
73849927|NCT02041299|147245812|NON_INFERIORITY|Support for non-inferiority is demonstrated if the 96.01% CI contains zero (0)|Mean Difference (Net)|-0.000295||||0.0399|TWO_SIDED|96.01|-0.054247|0.053657|||ANCOVA|||Data for this measure were log-transformed.||0.053657|-0.054247|0.0399
73849928|NCT02041299|147245813|NON_INFERIORITY|Support for non-inferiority of deferiprone to deferoxamine in serum ferritin is demonstrated if the 96.01% CI contains zero (0)|Mean Difference (Net)|375.07||||0.0399|TWO_SIDED|96.01|-260.63|1010.76|||ANCOVA|||||1010.76|-260.63|0.0399
73849929|NCT02041299|147245814|SUPERIORITY|Comparison of treatment groups on change in score on SF-36 Physical Summary||||||0.9214|||||||ANCOVA|||||||0.9214
73849930|NCT02041299|147245814|SUPERIORITY|||||||0.1174|||||||ANCOVA|||Comparison of treatment groups on change in score on SF-36 Mental Summary||||0.1174
73849931|NCT02041299|147245814|SUPERIORITY|||||||0.6488|||||||ANCOVA|||Comparison of treatment groups on change in score on CHQ-PF50 Physical Summary||||0.6488
73849932|NCT02041299|147245814|SUPERIORITY|||||||0.5915|||||||ANCOVA|||Comparison of treatment groups on change in score on CHQ-PF50 Psychosocial Summary||||0.5915
73849933|NCT00362882|147245830|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
73849934|NCT01072136|147245832|NON_INFERIORITY_OR_EQUIVALENCE|Under the assumption of a clinical cure proportion of 75% for the Azithromycin/Cefixime group, a 10% non-inferiority margin (i.e., no more than a 10% lower cure rate in the placebo group) at the one-sided 0.05 significance level with 85% power required 270 study participants in each arm (540 total) using an unpooled Z-test (normal approximation). Anticipating that approximately 30% of enrolled participants would not be in the per protocol group, 772 participants were targeted for enrollment.|Risk Difference (RD)|14.0|||||ONE_SIDED|95.0|-12.2||||||Asymptotic one-sided 95% confidence limit for the difference in clinical cure proportions(placebo minus treatment) were computed so that the lower limit could be examined relative to the non-inferiority margin of -10%.|The primary efficacy outcome was MPC clinical cure at 2 months. This was a non-inferiority trial designed to reject the null hypothesis that placebo control is inferior to empiric therapy for MPC.|||-12.2|
73849935|NCT01342926|147245895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|90.0|-0.57|0.43|||||6 months visit|||0.43|-0.57|
73849936|NCT01342926|147245895|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.2|||||TWO_SIDED|90.0|-0.31|0.71|||||12 months visit|||0.71|-0.31|
73849937|NCT01342926|147245895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|90.0|-0.33|0.68|||||18 months visit|||0.68|-0.33|
73849938|NCT01342926|147245895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|90.0|-0.71|0.26|||||6 months visit|||0.26|-0.71|
73849939|NCT01342926|147245895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|90.0|-0.26|0.72|||||12 months visit|||0.72|-0.26|
73849940|NCT01342926|147245895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.21|0.77|||||18 months visit|||0.77|-0.21|
73849941|NCT01342926|147245895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|90.0|-0.66|0.29|||||6 months visit|||0.29|-0.66|
73849942|NCT01342926|147245895|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.19|0.75|||||12 months visit|||0.75|-0.19|
73849943|NCT01342926|147245895|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.39|||||TWO_SIDED|90.0|-0.08|0.86|||||18 months visit|||0.86|-0.08|
73849944|NCT01342926|147245903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|90.0|-0.34|0.61|||||6 months visit|||0.61|-0.34|
73849945|NCT01342926|147245903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|||||TWO_SIDED|90.0|-0.07|0.89|||||12 months visit|||0.89|-0.07|
73849946|NCT01342926|147245903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|||||TWO_SIDED|90.0|-0.06|0.89|||||18 months visit|||0.89|-0.06|
73849947|NCT01342926|147245903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|90.0|-0.55|0.37|||||6 months visit|||0.37|-0.55|
74023880|NCT01381094|147600253|SUPERIORITY||||||=|0.2151|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2151
73849948|NCT01342926|147245903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.13|0.8|||||12 months visit|||0.80|-0.13|
73849949|NCT01342926|147245903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|90.0|-0.3|0.63|||||18 months visit|||0.63|-0.30|
73849950|NCT01342926|147245903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||||TWO_SIDED|90.0|-0.31|0.57|||||6 months visit|||0.57|-0.31|
73961606|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=207 and Adj. GMC =1.58 in 12Pn Group and N= 203 and Adj. GMC= 1.35 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.72|1.02||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.02|0.72|
73961607|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.94 in 12Pn Group and N= 203 and Adj. GMC= 1.66 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.7|1.05||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.05|0.70|
73961608|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =2.37 in 12Pn Group and N= 201 and Adj. GMC= 2.16 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||TWO_SIDED|95.8|0.78|1.07||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.07|0.78|
73961609|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.56 in 12Pn Group and N= 200 and Adj. GMC= 0.47 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.84||||||95.8|0.64|1.11||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.11|0.64|
73849951|NCT01342926|147245903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|||||TWO_SIDED|90.0|0.1|0.99|||||12 months visit|||0.99|0.10|
73849952|NCT01342926|147245903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|||||TWO_SIDED|90.0|0.47|1.36|||||18 months visit|||1.36|0.47|
73849953|NCT01342926|147245904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-0.34|0.55|||||6 months visit|||0.55|-0.34|
73849954|NCT01342926|147245904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|||||TWO_SIDED|90.0|0.0|0.9|||||12 months visit|||0.90|0.00|
73849955|NCT01342926|147245904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.12|0.77|||||18 months visit|||0.77|-0.12|
73849956|NCT01342926|147245904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|90.0|-0.51|0.35|||||6 months visit|||0.35|-0.51|
73849957|NCT01342926|147245904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|90.0|-0.21|0.66|||||12 months visit|||0.66|-0.21|
73849958|NCT01342926|147245904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|90.0|-0.32|0.55|||||18 months visit|||0.55|-0.32|
73849959|NCT01342926|147245904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.48|0.35|||||6 months visit|||0.35|-0.48|
73849960|NCT01342926|147245904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|90.0|-0.22|0.62|||||12 months visit|||0.62|-0.22|
73849961|NCT01342926|147245904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|90.0|0.08|0.92|||||18 months visit|||0.92|0.08|
73849962|NCT01445847|147245947|SUPERIORITY_OR_OTHER||Percentage|5.0|||<|0.05|TWO_SIDED|95.0|1.7|9.1|||Comparison of proportions|||We used incidence reported to AIMS study to calculate the sample size of this study. We set the null hypothesis as (percentage point of laryngospasm incidence in placebo group (µ1) - percentage point of laryngospasm incidence in Lidocaine group (µ2) = 0), with alternative hypothesis is (µ1 \> µ2) by 5% was analyzed by comparison of two proportions. A sample size of 380 patients (190 per group) was adequate to detect a 5-percentage point difference in the incidence with 80% power and p = 0.05.||9.1|1.7|<0.05
73849963|NCT00125788|147245948|SUPERIORITY|||||||0.076|||||||Cochran-Mantel-Haenszel|||||||0.076
73849964|NCT00125788|147245949|SUPERIORITY|||||||0.072|||||||Cochran-Mantel-Haenszel|||||||0.072
73849965|NCT00125788|147245950|SUPERIORITY|||||||0.129|||||||Cochran-Mantel-Haenszel|||||||0.129
73849966|NCT03008070|147245971|SUPERIORITY||Risk Ratio (RR)|1.52|||=|0.061|TWO_SIDED|95.0|0.98|2.12|||Cochran-Mantel-Haenszel|||"The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 800 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).~The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders."||2.12|0.98|=0.061
74023881|NCT01381094|147600253|SUPERIORITY||||||=|0.8436|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.8436
74023882|NCT01381094|147600253|SUPERIORITY||||||=|0.5962|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5962
74023883|NCT01381094|147600253|SUPERIORITY||||||=|0.3957|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.3957
74023884|NCT01381094|147600254|SUPERIORITY||||||=|0.0294|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0294
74023885|NCT01381094|147600254|SUPERIORITY||||||=|0.0021|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0021
74023886|NCT01381094|147600254|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0004
74084729|NCT03653026|147722722|SUPERIORITY||Adjusted Response Rate Difference|11.3|||<|0.001|TWO_SIDED|95.0|7.2|15.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||15.3|7.2|<0.001
73849967|NCT03008070|147245971|SUPERIORITY||Risk Ratio (RR)|1.82|||=|0.004|TWO_SIDED|95.0|1.24|2.4|||Cochran-Mantel-Haenszel|||"The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 1200 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).~The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders."||2.4|1.24|=0.004
73849968|NCT00841412|147245999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76|||<|0.05|TWO_SIDED|95.0|0.59|0.96|||Mixed Models Analysis||The above results are for just one of multiple feeding assistance care process measures: proportion of meals during which residents received assistance to eat baseline to post intervention.|||0.96|0.59|<0.05
74023887|NCT01381094|147600254|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0001
74023888|NCT01381094|147600254|SUPERIORITY||||||=|0.0925|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0925
74023889|NCT01381094|147600254|SUPERIORITY||||||=|0.0433|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0433
74023890|NCT01381094|147600254|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
73849969|NCT04409834|147246000|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.95||||0.028|TWO_SIDED|95.0|1.08|3.55|||Stratified Win-Ratio Analysis, 2-sided|||FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation||3.55|1.08|0.028
74023891|NCT01381094|147600254|SUPERIORITY||||||=|0.0005|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0005
74023892|NCT01381094|147600254|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
74023893|NCT01381094|147600254|SUPERIORITY||||||=|0.1626|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.1626
74023894|NCT01381094|147600254|SUPERIORITY||||||=|0.0366|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0366
73961610|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =2.42 in 12Pn Group and N= 202 and Adj. GMC= 2.17 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.9|||||TWO_SIDED|95.8|0.76|1.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.06|0.76|
73961611|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.78 in 12Pn Group and N= 200 and Adj. GMC= 1.40 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.79|||||TWO_SIDED|95.8|0.67|0.93||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||0.93|0.67|
73961612|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =4.48 in 12Pn Group and N= 201 and Adj. GMC= 4.10 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||TWO_SIDED|95.8|0.77|1.09||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.09|0.77|
73961613|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =2.55 in 12Pn Group and N= 201 and Adj. GMC= 2.57 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.01|||||TWO_SIDED|95.8|0.81|1.26||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.26|0.81|
73961614|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =3.29 in 12Pn Group and N= 202 and Adj. GMC= 3.67 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.12|||||TWO_SIDED|95.8|0.9|1.38||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.38|0.90|
73961615|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.68 in 12Pn Group and N= 199 and Adj. GMC= 0.71 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI..|Adjusted GMCs ratio|1.05|||||TWO_SIDED|95.8|0.81|1.37||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.37|0.81|
73961616|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=210 and Adj. GMC =1.09 in 12Pn Group and N= 214 and Adj. GMC= 2.07 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.9|||||TWO_SIDED|95.8|1.51|2.39||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||2.39|1.51|
73961617|NCT01616459|147459799|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.19 in 12Pn Group and N= 206 and Adj. GMC= 2.76 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|2.32|||||TWO_SIDED|95.8|1.94|2.77||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||2.77|1.94|
73961618|NCT01616459|147459800|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||TWO_SIDED|95.9|-3.89|1.36||||||ANTI-1 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.36|-3.89|
73961619|NCT01616459|147459800|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9% Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.08|||||TWO_SIDED|95.9|-4.94|2.45||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.45|-4.94|
73961620|NCT01616459|147459800|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.48|||||TWO_SIDED|95.9|-2.82|1.38||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.38|-2.82|
73961621|NCT01616459|147459800|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.24|||||TWO_SIDED|95.9|-10.65|6.13||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||6.13|-10.65|
73961622|NCT01616459|147459800|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.03|||||TWO_SIDED|95.9|-2.39|2.21||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.21|-2.39|
73961623|NCT01616459|147459800|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.4|||||TWO_SIDED|95.9|-2.36|3.22||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||3.22|-2.36|
73961624|NCT01616459|147459800|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.45|||||TWO_SIDED|95.9|-1.51|2.66||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.66|-1.51|
73961625|NCT01616459|147459800|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.0|||||TWO_SIDED|95.9|-4.18|1.7||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.70|-4.18|
73961626|NCT01616459|147459800|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.38|||||TWO_SIDED|95.9|-5.64|-0.52||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||-0.52|-5.64|
73971026|NCT04119843|147482210|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.805|<|0.001|TWO_SIDED|95.0|0.555|0.971|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 1||0.971|0.555|<0.001
73849970|NCT04409834|147246001|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.79||||0.087|TWO_SIDED|95.0|0.92|3.47|||Stratified Win-Ratio Analysis, 2-sided|||FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation||3.47|0.92|0.087
73849971|NCT04409834|147246002|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.04||||0.9|TWO_SIDED|95.0|0.54|2.01|||Stratified Win-Ratio Analysis, 2-sided|||||2.01|0.54|0.90
73849972|NCT04409834|147246003|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|0.79||||0.53|TWO_SIDED|95.0|0.38|1.65|||Stratified Win-Ratio Analysis, 2-sided|||||1.65|0.38|0.53
73849973|NCT00928187|147246025|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesizing 80% efficacy at the 50 copies/mL Viral Load (VL) threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|differences in proportions|5.6|||||TWO_SIDED|95.0|-5.1|16.4||||||||16.4|-5.1|
73849974|NCT00928187|147246025|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesizing 80% efficacy at the 50 copies/mL VL threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|difference in proportions|6.1|||||TWO_SIDED|95.0|-4.5|16.7||||||||16.7|-4.5|
74023895|NCT01381094|147600254|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0004
73849975|NCT00928187|147246030|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||||||0.001
73849976|NCT00928187|147246031|SUPERIORITY_OR_OTHER|||||||0.26|||||||Chi-squared|||||||0.26
73849977|NCT00928187|147246032|SUPERIORITY_OR_OTHER|||||||0.13|||||||Chi-squared|||||||0.13
73849978|NCT01682356|147246038|SUPERIORITY|||||||0.0153|||||||t-test, 2 sided|Paired||||||0.0153
73849979|NCT01682356|147246039|SUPERIORITY|||||||0.0131|||||||t-test, 2 sided|Paired||||||0.0131
73849980|NCT01682356|147246040|SUPERIORITY|||||||0.83||||||P value adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.83
73849981|NCT01682356|147246041|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 6.06 x 10\^-18.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
73849982|NCT01682356|147246042|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 1.87 x 10\^-20.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
73849983|NCT01682356|147246043|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 8.23 x 10\^-21.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
73849984|NCT01682356|147246044|SUPERIORITY|||||||0.6847||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6847
73849985|NCT01682356|147246045|SUPERIORITY|||||||0.6847||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6847
73849986|NCT01682356|147246046|SUPERIORITY|||||||0.4078||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.4078
73849987|NCT01682356|147246047|SUPERIORITY|||||||0.4078||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.4078
73849988|NCT01682356|147246048|SUPERIORITY|||||||0.3042||||||P value adjusted for multiplicity|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3042
74023896|NCT01381094|147600254|SUPERIORITY||||||=|0.0012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0012
73849989|NCT01682356|147246049|SUPERIORITY||||||<|1e-07||||||P value adjusted for multiplicity. Exact P value 3.469 x 10\^-7.|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
73849990|NCT01682356|147246050|SUPERIORITY||||||<|1e-07||||||P value adjusted for multiplicity. Exact P value 7.202 x 10\^-8|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
73849991|NCT01682356|147246051|SUPERIORITY|||||||2.13e-06||||||P value adjusted for multiplicity. Exact P value 2.129 x 10\^-6.|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.00000213
73849992|NCT01682356|147246052|SUPERIORITY|||||||0.3918||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3918
73849993|NCT01682356|147246053|SUPERIORITY|||||||0.0598||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.05980
73849994|NCT01682356|147246054|SUPERIORITY|||||||0.3918||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3918
73849995|NCT01682356|147246055|SUPERIORITY|||||||0.0987||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.09870
73849996|NCT01682356|147246056|SUPERIORITY|||||||0.6044||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6044
73849997|NCT01682356|147246057|SUPERIORITY|||||||0.6044||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6044
73849998|NCT01682356|147246058|SUPERIORITY|||||||0.8819||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.8819
73849999|NCT01682356|147246059|SUPERIORITY|||||||0.8987||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.8987
73850000|NCT02079909|147246109|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.3919|TWO_SIDED||||||Mixed Models Analysis|||||||0.3919
73850001|NCT02079909|147246110|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.7588|TWO_SIDED||||||Mixed Models Analysis|||||||0.7588
73850002|NCT02079909|147246111|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.3212|TWO_SIDED||||||Mixed Models Analysis|||||||0.3212
73850003|NCT02277249|147246112|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||No power calculation performed given that this was a pilot study. The null hypothesis was that there would be no difference in pain score with injection between the two study arms. The Wilcoxon rank sum test was selected because of the study's small sample size and the non-normal distribution of pain scores. Intention to treat analyses were used.||||0.36
73850004|NCT01869634|147246130|OTHER|Wilcoxon signed-rank test. Paired samples.||||||0.0025|||||||Sign test|||Comparison between HIV positive naïve to ART before and after ART has been done.||||0.0025
73850005|NCT01869634|147246131|OTHER|Two-sample Wilcoxon rank-sum (Mann-Whitney) test||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
73850006|NCT01869634|147246131|OTHER|Wilcoxon signed-rank test||||||0.826|||||||Sign test|||Comparison of coronary artery wall thickness before and after ART in the HIV infected participants.||||0.826
73850007|NCT01869634|147246132|OTHER|Two-sample Wilcoxon rank-sum (Mann-Whitney) test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||comparison between groups (HIV+ vs HIV-)||||<0.001
73850008|NCT01869634|147246132|OTHER|||||||0.807|||||||Sign test|||Changes in systemic immune activation through IL6||||0.807
73850009|NCT01693250|147246148|SUPERIORITY||Mean Difference (Final Values)|1.68|STANDARD_DEVIATION|0.5|<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||This is a feasibility and pilot study. We acknowledge that our sample size will not have adequate power to detect any statistically significant outcomes. We chose a sample size that would be large enough to assess feasibility and effect size and to accommodate recruitment within the study time and budget of this application. We hope to be able to estimate the effect size of the intervention.||||<.001
73850010|NCT01693250|147246149|SUPERIORITY||Mean Difference (Final Values)|2.66||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||We hypothesized the intervention group will have significant reduction of systematic blood pressure compared to the control group at 6 month follow up.||||.001
74023897|NCT01381094|147600254|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
73850011|NCT00559104|147246236|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.51||||0.51|TWO_SIDED|95.0|0.07|3.79|||Regression, Cox||"Parameter Dispersion Type: Standard Error of the Parameter Estimate, not of the mean.~Standard Error = 1.02475"|There is no power calculation as this is a phase II study. This is an Event-free Survival, in which an event can be Relapse/Progression, or Death. Censoring can be at the End of follow-up date, or at the End of study date.||3.79|0.07|0.51
73850012|NCT00559104|147246237|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.66||||0.69|TWO_SIDED|95.0|0.09|4.99|||Regression, Cox||"Numerator: Carmustine in the conditioning. Denominator: Irradiation in the conditioning.~Parameter: Hazard ratio. Dispersion: Standard Error of the Hazard Ratio."|Phase II analysis: There was no power calculation.||4.99|0.09|0.69
73850013|NCT00620373|147246247|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||Significant difference p ≤ 0.05||||.016
73850014|NCT00620373|147246247|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||McNemar|||significant difference p ≤ 0.05||||.07
73850015|NCT00620373|147246248|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||McNemar|||For all cancers; significant difference p ≤ 0.05||||.016
73850016|NCT00620373|147246248|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||McNemar|||For all cancers; significant difference p ≤ 0.05||||.07
73850017|NCT00620373|147246248|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||McNemar|||For invasive cancers; significant difference p ≤ 0.05||||.063
73850018|NCT00620373|147246248|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||McNemar|||For invasive cancers; significant difference p ≤ 0.05||||.063
73850019|NCT00620373|147246248|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05||||.5
73850020|NCT00620373|147246248|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05||||>.99
73850021|NCT00620373|147246250|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||significant difference p ≤ 0.05||||<.001
73850022|NCT00620373|147246250|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||McNemar|||significant difference p ≤ 0.05||||.069
73850023|NCT00620373|147246251|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||significant difference p ≤ 0.05||||<.001
73850024|NCT00620373|147246251|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||McNemar|||significant difference p ≤ 0.05||||.218
73850025|NCT01516632|147246275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|0.82|3.21||||||||3.21|.82|
73850026|NCT01516632|147246276|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55|||||TWO_SIDED|95.0|1.22|5.3||||||||5.30|1.22|
73850027|NCT01516632|147246277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||||TWO_SIDED|95.0|1.48|7.45||||||||7.45|1.48|
73850028|NCT01152788|147246285|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.6|2.01|||Log Rank|||||2.01|0.6|0.76
73850029|NCT01152788|147246286|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-18.7|16.8||||||||16.8|-18.7|
73850030|NCT01152788|147246287|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.55|TWO_SIDED|95.0|0.38|1.68|||Log Rank|||||1.68|0.38|0.55
73850031|NCT01152788|147246288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Chi-squared|||||||0.01
73850032|NCT01282866|147246289|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73850033|NCT03502915|147246306|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.053|STANDARD_DEVIATION|2.508||0.943|TWO_SIDED|95.0|-1.402|1.507|||t-test, 2 sided|||||1.507|-1.402|0.943
74023898|NCT01381094|147600254|SUPERIORITY||||||=|0.1779|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.1779
74023899|NCT01381094|147600254|SUPERIORITY||||||=|0.5867|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5867
73850034|NCT03502915|147246307|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.443|STANDARD_DEVIATION|2.867||0.597|TWO_SIDED|95.0|-1.229|2.114|||t-test, 2 sided|||||2.114|-1.229|0.597
73850035|NCT03502915|147246308|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|1.28||0.748|TWO_SIDED|95.0|-0.629|0.869|||t-test, 2 sided|||||0.869|-0.629|0.748
73850036|NCT03502915|147246309|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|-2.634|STANDARD_DEVIATION|3.816||0.025|TWO_SIDED|95.0|-4.927|-0.341|||t-test, 2 sided|||||-0.341|-4.927|0.025
73850037|NCT03502915|147246310|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.056|STANDARD_DEVIATION|2.742||0.944|TWO_SIDED|95.0|-1.543|1.655|||t-test, 2 sided|||||1.655|-1.543|0.944
73850038|NCT01964378|147246311|NON_INFERIORITY|Non-inferiority margin of 8 mg. Assuming equal mean values in both the cebranopadol and morphine groups, it was calculated that for the final analysis of the primary endpoint 170 subjects would have been required per treatment arm in the Per Protocol Set using a 2 sample-t-test for 90% power and a 1-sided significance level of α = 0.025.|point-estimate|-7.48|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-12.05|-2.918|||MMRM|||The MMRM (mixed model repeated measurement) model includes fixed effects of pooled country, treatment, week, treatment-by-week interaction, history of opioid intake, baseline pain intensity as covariate \& subject-specific random effects. Dependent variable being the weekly average rescue medication intake.||-2.918|-12.05|< 0.0001
73961627|NCT01616459|147459800|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.73|||||TWO_SIDED|95.9|-4.84|10.25||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||10.25|-4.84|
73961628|NCT01616459|147459801|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.89|||||TWO_SIDED|95.9|-1.46|3.66||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||3.66|-1.46|
74023900|NCT01381094|147600254|SUPERIORITY||||||=|0.1306|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1306
74023901|NCT01381094|147600254|SUPERIORITY||||||=|0.9889|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9889
74023902|NCT01381094|147600254|SUPERIORITY||||||=|0.2026|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2026
74023903|NCT01381094|147600254|SUPERIORITY||||||=|0.5703|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5703
74023904|NCT01381094|147600255|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
73961629|NCT01616459|147459802|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.49|||||TWO_SIDED|95.8|-3.44|2.22||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.22|-3.44|
73961630|NCT01616459|147459802|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.06|||||TWO_SIDED|95.8|-4.03|3.86||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.86|-4.03|
73961631|NCT01616459|147459802|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.01|||||TWO_SIDED|95.8|-2.37|2.3||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.30|-2.37|
74023905|NCT01381094|147600255|SUPERIORITY||||||=|0.0092|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0092
74023906|NCT01381094|147600255|SUPERIORITY||||||=|0.0012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0012
74023907|NCT01381094|147600255|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
74023908|NCT01381094|147600255|SUPERIORITY||||||=|0.1157|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1157
74023909|NCT01381094|147600255|SUPERIORITY||||||=|0.0069|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0069
74023910|NCT01381094|147600255|SUPERIORITY||||||=|0.0034|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0034
74023911|NCT01381094|147600255|SUPERIORITY||||||=|0.0067|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0067
74023912|NCT01381094|147600255|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
74023913|NCT01381094|147600255|SUPERIORITY||||||=|0.0401|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0401
73850039|NCT01964378|147246312|NON_INFERIORITY|Non-inferiority margin of 8 mg. Assuming that 65% of the participants are available for the Per Protocol Set, a total of 524 participant would have to be allocated (randomized) to IMP. With 262 participants per group in the Full Analysis Set, the non-inferiority of cebranopadol as compared to morphine sulfate prolonged release could have been demonstrated with at least 98% power and a 1-sided significance level of α = 0.025.|point-estimate|-4.67|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-9.245|-0.099||MMRM model: fixed effects of pooled country, treatment, week, treatment-by-week interaction, opioid intake history, baseline pain intensity as covariate \& subject-specific random effects. Dependent variable: weekly average rescue medication intake.|MMRM (mixed model repeated measurement)|For participants with no data in the Maintenance Phase, the average amount of rescue medication over the last 3 days of titration was imputed.|Non-inferiority of cebranopadol compared with morphine will be established if the upper bound of the resulting 95% confidence interval for the average treatment difference is below the non-inferiority margin of 8mg.|The primary endpoint will be analyzed by means of a mixed-effects model for repeated measures (MMRM), based on observed case weekly averages. Under the assumption of a missing-at-random missing data mechanism, an MMRM does not require an imputation of missing data and can obtain an improved estimate of variance.||-0.099|-9.245|< 0.0001
73850040|NCT01392573|147246344|SUPERIORITY_OR_OTHER||Treatment contrast|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.84|||ANCOVA|ANCOVA model with treatment, country and previous antidiabetic treatment as fixed effects and baseline HbA1c value as covariate||||-0.84|-1.25|<0.0001
73850041|NCT01102491|147246363|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73850042|NCT03533660|147246375|SUPERIORITY||||||<|0.05||||||Applies to SOCRATES subscales recognition, ambivalence, taking steps at 6 weeks|t-test, 2 sided|||||||<.05
73850043|NCT03533660|147246375|SUPERIORITY||||||>|0.05||||||Applies to SOCRATES total scores and subscales (recognition, ambivalence, and taking steps) at intake and 3 months|t-test, 2 sided|||||||>.05
73850044|NCT03533660|147246376|SUPERIORITY||||||>|0.05||||||Applies to alcohol self-efficacy scale total score and subscales scores at intake, 6 weeks and 3 months|t-test, 2 sided|||||||>.05
73850045|NCT00996658|147246379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.0001||95.0|-0.83|-0.31|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.31|-0.83|< 0.0001
73850046|NCT00996658|147246380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.0001||95.0|-0.61|-0.21|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.21|-0.61|< 0.0001
73850047|NCT00996658|147246381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.79|-0.28|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.28|-0.79|< 0.0001
73850048|NCT00996658|147246382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.8|-0.29|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.29|-0.80|< 0.0001
73850049|NCT00996658|147246383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.939||||0.0033|TWO_SIDED|95.0|1.432|6.032|||Regression, Logistic|||Linagliptin vs Placebo||6.032|1.432|0.0033
73850050|NCT00996658|147246384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.902||||0.0074|TWO_SIDED|95.0|1.44|10.572|||Regression, Logistic|||Linagliptin vs Placebo||10.572|1.440|0.0074
73850051|NCT00996658|147246385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.059||||0.0071|TWO_SIDED|95.0|1.216|3.485|||Regression, Logistic|||Linagliptin vs. Placebo||3.485|1.216|0.0071
73850052|NCT00996658|147246386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.028||95.0|-19.6|-1.1|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-1.1|-19.6|0.0280
73850053|NCT00996658|147246387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7||||0.0006||95.0|-24.5|-6.8|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-6.8|-24.5|0.0006
73850054|NCT00996658|147246388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.021||95.0|-20.2|-1.7|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-1.7|-20.2|0.0210
73850055|NCT00996658|147246389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.2137||95.0|-16.0|3.6|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||3.6|-16.0|0.2137
73850056|NCT02975804|147246482|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
73850057|NCT02975804|147246483|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
73850058|NCT02975804|147246484|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
73850059|NCT02975804|147246485|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
73850060|NCT02975804|147246486|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
73850061|NCT02975804|147246487|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
73850062|NCT02975804|147246491|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
73850063|NCT02975804|147246492|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
73850064|NCT04263766|147246519|EQUIVALENCE|We tested whether TMS delivered to DLPFC had a difference effect on confidence compared to delivered to Vertex.|||||<|0.001|||||||t-test, 2 sided|||Our null hypothesis is TMS to DLPFC would not lead to a significant change in confidence across all 4 delay conditions compared to TMS to the vertex.||||<.001
73850065|NCT04263766|147246519|EQUIVALENCE|We tested whether TMS to DLPFC leads to equivalent increase in confidence for four delay conditions.||||||0.99|||||||ANOVA|||||||0.99
73850066|NCT04263766|147246519|EQUIVALENCE|We tested whether TMS delivered to Vertex leads to a same effect on confidence regardless of the delay conditions.||||||0.83|||||||ANOVA|||||||0.83
73850067|NCT04263766|147246520|EQUIVALENCE|We used a two-way ANOVA to test whether TMS affected Mratio differently for DLPFC and Vertex and across different delay conditions.|||||>|0.19|||||||ANOVA|||Our null hypothesis is TMS to DLPFC would not lead to a significant change in Mratio across all 4 delay conditions compared to TMS to the vertex.||||>0.19
73850068|NCT01891396|147246525|SUPERIORITY|||||||0.0099|||||||ANOVA|||||||0.0099
73850069|NCT01891396|147246526|SUPERIORITY|||||||0.0367|||||||ANOVA|||||||0.0367
73850070|NCT01891396|147246527|SUPERIORITY|||||||0.0289|||||||ANOVA|||||||0.0289
73850071|NCT01891396|147246528|SUPERIORITY|||||||0.0141|||||||ANOVA|||||||0.0141
73850072|NCT01891396|147246529|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
73850073|NCT01891396|147246530|SUPERIORITY|||||||0.0533|||||||ANOVA|||||||0.0533
73961632|NCT01616459|147459802|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-4.67|||||TWO_SIDED|95.8|-12.94|3.6||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.60|-12.94|
73961633|NCT01616459|147459802|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.46|||||TWO_SIDED|95.8|-1.93|3.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.06|-1.93|
74023914|NCT01381094|147600255|SUPERIORITY||||||=|0.0042|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0042
74023915|NCT01381094|147600255|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
73850074|NCT01891396|147246531|SUPERIORITY|||||||0.0323|||||||ANOVA|||||||0.0323
73850075|NCT01891396|147246532|SUPERIORITY|||||||0.0072|||||||ANOVA|||||||0.0072
73850076|NCT01891396|147246533|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.0030
73850077|NCT01891396|147246534|SUPERIORITY|||||||0.044|||||||ANOVA|||||||0.0440
73850078|NCT01891396|147246535|SUPERIORITY|||||||0.0579|||||||ANOVA|||||||0.0579
73850079|NCT01891396|147246536|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
73850080|NCT01891396|147246537|SUPERIORITY|||||||0.0046|||||||ANOVA|||||||0.0046
73850081|NCT01891396|147246538|SUPERIORITY|||||||0.0029|||||||ANOVA|||||||0.0029
73850082|NCT01891396|147246539|SUPERIORITY|||||||0.0087|||||||ANOVA|||||||0.0087
73850083|NCT01891396|147246540|SUPERIORITY|||||||0.0154|||||||ANOVA|||||||0.0154
73850084|NCT01891396|147246541|SUPERIORITY|||||||0.0227|||||||ANOVA|||||||0.0227
73850085|NCT01891396|147246542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||ANOVA|||||||0.0002
73850086|NCT01891396|147246543|SUPERIORITY|||||||0.0148|||||||ANOVA|||||||0.0148
73850087|NCT01891396|147246544|SUPERIORITY|||||||0.0113|||||||ANOVA|||||||0.0113
73850088|NCT01891396|147246545|SUPERIORITY|||||||0.0016|||||||ANOVA|||||||0.0016
73850089|NCT01891396|147246546|SUPERIORITY|||||||0.0056|||||||ANOVA|||||||0.0056
73850090|NCT01891396|147246547|SUPERIORITY|||||||0.0095|||||||ANOVA|||||||0.0095
73850091|NCT01891396|147246548|SUPERIORITY|||||||0.0136|||||||ANOVA|||||||0.0136
73850092|NCT01891396|147246549|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
73850093|NCT01891396|147246550|SUPERIORITY|||||||0.0059|||||||ANOVA|||||||0.0059
73850094|NCT02413996|147246589|SUPERIORITY||Mean Difference (Net)|5.94|STANDARD_DEVIATION|5.3||0.05|TWO_SIDED|95.0|-4.62|16.51|||t-test, 2 sided|||Does VRRS rehabilitation is superior to the traditional one?||16.51|-4.62|0.05
73850095|NCT03810014|147246602|SUPERIORITY||Risk Difference (RD)|2.5||||0.01|TWO_SIDED|98.0|0.2|4.8|||Generalized estimating equations|||(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)||4.80|0.20|0.01
73850096|NCT03810014|147246602|SUPERIORITY||Risk Ratio, log|1.025||||0.012|TWO_SIDED|98.0|1.002|1.049|||Generalized estimating equations|||(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)||1.049|1.002|0.012
73850097|NCT03810014|147246602|SUPERIORITY||Risk Difference (RD)|-0.6||||0.33|TWO_SIDED|98.0|-2.2|0.9|||Generalized estimating equations|||(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)||0.90|-2.20|0.33
73850098|NCT03810014|147246602|SUPERIORITY||Risk Ratio, log|0.994||||0.332|TWO_SIDED|98.0|0.979|1.009|||Generalized estimating equations|||(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)||1.009|0.979|0.332
73850099|NCT01107964|147246663|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
73850100|NCT01107964|147246664|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
73850101|NCT01107964|147246665|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
73850102|NCT01107964|147246666|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
73850103|NCT02148263|147246738|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
73850104|NCT02148263|147246739|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
73850105|NCT02148263|147246740|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||.94
73850106|NCT02148263|147246741|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||.96
73850107|NCT02148263|147246742|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
73850108|NCT02148263|147246743|SUPERIORITY|This is for the upper eyelid evaluation.||||||0.27|||||||Fisher Exact|||||||.27
73850109|NCT02148263|147246743|SUPERIORITY|||||||0.58|||||||Fisher Exact|||This is for the lower eyelid evaluation.||||.58
73850110|NCT02148263|147246744|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Extent||||.50
73850111|NCT02148263|147246744|SUPERIORITY|||||||0.76|||||||Fisher Exact|||Type||||.76
73850112|NCT02148263|147246744|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Depth||||.50
73850113|NCT02148263|147246745|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
73850114|NCT02148263|147246746|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
73961634|NCT01616459|147459802|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.02|||||TWO_SIDED|95.8|-2.72|2.64||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.64|-2.72|
73850117|NCT00906178|147246772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.57|1.94||||||||1.94|.57|
73850118|NCT00906178|147246773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.62|1.65||||||||1.65|.62|
73850119|NCT00906178|147246774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.93|2.62||||||||2.62|.93|
73850120|NCT00906178|147246775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.37|1.3||||||||1.30|.37|
73850121|NCT01467466|147246776|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7|TWO_SIDED|95.0|0.73|1.24|||Wald's Chi-Square|||||1.24|0.73|0.70
73850122|NCT01467466|147246777|SUPERIORITY||Odds Ratio (OR)|1.02||||0.86|TWO_SIDED|95.0|0.78|1.34|||Wald's Chi-Square|||||1.34|0.78|0.86
73850123|NCT01144416|147246787|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -8%|Difference in percentage vital pregnancy|-3.0|||||TWO_SIDED|95.0|-7.4|1.4|||generalized linear model|The estimated difference in percentage vital pregnancy was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs)||||1.4|-7.4|
73850124|NCT01144416|147246788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -3 oocytes.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.2|1.2|||ANOVA|The estimated difference in number of oocytes retrieved was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs) and center.||||1.2|-0.2|
73850125|NCT01144416|147246789|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -8%|Difference in Live Birth Rates|-2.3|||||TWO_SIDED|95.0|-6.5|1.9|||generalized linear model|The estimated difference in live birth rate was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs)||||1.9|-6.5|
73850126|NCT01144416|147246790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Fisher Exact|||||||0.30
73850127|NCT01144416|147246791|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
73850128|NCT03328832|147246804|EQUIVALENCE|equivalence means p value \> 0.05||||||0.276|||||||t-test, 2 sided|||||||0.276
73850129|NCT03328832|147246805|EQUIVALENCE|equivalence means p value \> 0.05||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
73850130|NCT03328832|147246806|EQUIVALENCE|Equivalence means p value \> 0.05||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
73850131|NCT00778336|147246817|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
73850132|NCT00778336|147246817|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
73850133|NCT00778336|147246817|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
73850134|NCT00778336|147246817|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
73850135|NCT00873821|147246822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.83|||<|0.001|TWO_SIDED|95.0|26.33|55.32|||Mixed Models Analysis|||Difference (placebo minus MK-0941) in change from baseline to Day 13||55.32|26.33|<0.001
73850136|NCT02891226|147246834|SUPERIORITY||Odds Ratio (OR)|2.75||||0.079|TWO_SIDED|90.0|1.07|7.08|||Regression, Logistic|||||7.08|1.07|0.079
73850137|NCT02891226|147246834|SUPERIORITY||Odds Ratio (OR)|4.92||||0.003|TWO_SIDED|90.0|2.01|12.07|||Regression, Logistic|||||12.07|2.01|0.003
73850138|NCT02891226|147246834|SUPERIORITY||Odds Ratio (OR)|6.14|||<|0.001|TWO_SIDED|90.0|2.81|13.42|||Regression, Logistic|||||13.42|2.81|<0.001
73850139|NCT02891226|147246835|SUPERIORITY||Odds Ratio (OR)|4.31||||0.241|TWO_SIDED|90.0|0.55|33.58|||Regression, Logistic|||||33.58|0.55|0.241
73850140|NCT02891226|147246835|SUPERIORITY||Odds Ratio (OR)|11.16||||0.032|TWO_SIDED|90.0|1.76|70.64|||Regression, Logistic|||||70.64|1.76|0.032
73850141|NCT02891226|147246835|SUPERIORITY||Odds Ratio (OR)|16.04||||0.009|TWO_SIDED|90.0|2.82|91.32|||Regression, Logistic|||||91.32|2.82|0.009
73850142|NCT02891226|147246836|SUPERIORITY||Odds Ratio (OR)|2.0||||0.33|TWO_SIDED|90.0|0.62|6.45|||Regression, Logistic|||||6.45|0.62|0.330
73850143|NCT02891226|147246836|SUPERIORITY||Odds Ratio (OR)|5.72||||0.006|TWO_SIDED|90.0|2.02|16.21|||Regression, Logistic|||||16.21|2.02|0.006
73850144|NCT02891226|147246836|SUPERIORITY||Odds Ratio (OR)|3.52||||0.029|TWO_SIDED|90.0|1.37|9.07|||Regression, Logistic|||||9.07|1.37|0.029
73850145|NCT02891226|147246837|SUPERIORITY||LS Mean difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.234||0.007|TWO_SIDED|90.0|-1.03|-0.25|||Mixed Models Analysis|||||-0.25|-1.03|0.007
73961635|NCT01616459|147459802|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.0|||||TWO_SIDED|95.8|-1.94|1.9||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||1.90|-1.94|
74023916|NCT01381094|147600255|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0002
74023917|NCT01381094|147600255|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
73850146|NCT02891226|147246837|SUPERIORITY||LS Mean difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|90.0|-1.21|-0.45|||Mixed Models Analysis|||||-0.45|-1.21|<0.001
73850147|NCT02891226|147246837|SUPERIORITY||LS Mean difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.188||0.005|TWO_SIDED|90.0|-0.84|-0.22|||Mixed Models Analysis|||||-0.22|-0.84|0.005
73850148|NCT02891226|147246839|SUPERIORITY||LS Mean difference (Final Values)|24.05|STANDARD_ERROR_OF_MEAN|6.358|<|0.001|TWO_SIDED|90.0|13.53|34.56|||Mixed Models Analysis|||||34.56|13.53|<0.001
73850149|NCT02891226|147246839|SUPERIORITY||LS Mean difference (Final Values)|29.46|STANDARD_ERROR_OF_MEAN|6.421|<|0.001|TWO_SIDED|90.0|18.84|40.08|||Mixed Models Analysis|||||40.08|18.84|<0.001
73850150|NCT02891226|147246839|SUPERIORITY||LS Mean difference (Final Values)|25.24|STANDARD_ERROR_OF_MEAN|5.185|<|0.001|TWO_SIDED|90.0|16.67|33.82|||Mixed Models Analysis|||||33.82|16.67|<0.001
73850151|NCT02891226|147246840|SUPERIORITY||LS Mean difference (Final Values)|7.91|STANDARD_ERROR_OF_MEAN|2.072|<|0.001|TWO_SIDED|90.0|4.48|11.34|||Mixed Models Analysis|||||11.34|4.48|<0.001
73850152|NCT02891226|147246840|SUPERIORITY||LS Mean difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|2.102||0.004|TWO_SIDED|90.0|2.72|9.67|||Mixed Models Analysis|||||9.67|2.72|0.004
73850153|NCT02891226|147246840|SUPERIORITY||LS Mean difference (Final Values)|6.73|STANDARD_ERROR_OF_MEAN|1.686|<|0.001|TWO_SIDED|90.0|3.94|9.51|||Mixed Models Analysis|||||9.51|3.94|<0.001
73850154|NCT02891226|147246841|SUPERIORITY||LS Mean difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|1.927||0.008|TWO_SIDED|90.0|1.95|8.32|||Mixed Models Analysis|||Mental Component Summary (MCS)||8.32|1.95|0.008
73850155|NCT02891226|147246841|SUPERIORITY||LS Mean difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|1.951||0.033|TWO_SIDED|90.0|0.96|7.41|||Mixed Models Analysis|||Mental Component Summary (MCS)||7.41|0.96|0.033
73850156|NCT02891226|147246841|SUPERIORITY||LS Mean difference (Final Values)|3.71|STANDARD_ERROR_OF_MEAN|1.589||0.021|TWO_SIDED|90.0|1.08|6.34|||Mixed Models Analysis|||Mental Component Summary (MCS)||6.34|1.08|0.021
73850157|NCT02891226|147246841|SUPERIORITY||LS Mean difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.319||0.229|TWO_SIDED|90.0|-0.59|3.77|||Mixed Models Analysis|||Physical Component Summary (PCS)||3.77|-0.59|0.229
73850158|NCT02891226|147246841|SUPERIORITY||LS Mean difference (Final Values)|4.91|STANDARD_ERROR_OF_MEAN|1.349|<|0.001|TWO_SIDED|90.0|2.67|7.14|||Mixed Models Analysis|||Physical Component Summary (PCS)||7.14|2.67|<0.001
73850159|NCT02891226|147246841|SUPERIORITY||LS Mean difference (Final Values)|3.6|STANDARD_ERROR_OF_MEAN|1.078||0.001|TWO_SIDED|90.0|1.81|5.38|||Mixed Models Analysis|||Physical Component Summary (PCS)||5.38|1.81|0.001
73850160|NCT00145626|147246845|SUPERIORITY_OR_OTHER||Cumulative Incidence|0.214|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED||||||||The cumulative incidence estimate and its standard error for occurrence of regimen-related mortality by the end of the first 100 days post-transplant was calculated.|||||
73850161|NCT04446312|147246934|NON_INFERIORITY|The pre-defined non-inferiority margin was 10%.|Risk Difference (RD)|0.15|||<|0.001|TWO_SIDED|95.0|-3.97|4.27|||Mantel Haenszel|||||4.27|-3.97|<0.001
73850162|NCT00200967|147246962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|7.0||0.99||95.0|-14.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for AM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design. A sample size of 40 participants per genotype was required to detect a difference of 25 L/min in AM PEF (and relevant effect sizes for secondary outcomes) with a two-sided, 0.05 significance level test with 90% statistical power and a 15% drop-out rate.||14|-14|0.99
74023918|NCT01381094|147600255|SUPERIORITY||||||=|0.0422|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0422
73850163|NCT00200967|147246963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|7.0||0.82||95.0|-15.0|12.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||12|-15|0.82
73850164|NCT00200967|147246964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.31||95.0|-1.6|0.5|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PEF variability.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.5|-1.6|0.31
73961636|NCT01616459|147459802|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.5|||||TWO_SIDED|95.8|-3.72|2.52||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.52|-3.72|
73961637|NCT01616459|147459802|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||TWO_SIDED|95.8|-4.38|2.1||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.10|-4.38|
73961638|NCT01616459|147459802|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.5|||||TWO_SIDED|95.8|-5.07|10.06||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||10.06|-5.07|
74023919|NCT01381094|147600255|SUPERIORITY||||||=|0.0232|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0232
74023920|NCT01381094|147600255|SUPERIORITY||||||=|0.0243|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0243
73850165|NCT00200967|147246965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.09||95.0|-0.02|0.07|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for asthma symptoms.|A mixed-effects linear model was attempted but could not converge because very few symptoms were recorded, so a nonparametric analysis was applied.||0.07|-0.02|0.09
73850166|NCT00200967|147246966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.25||95.0|-0.1|0.2|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for rescue medication use.|A mixed-effects linear model was attempted but could not converge because very few usages of rescue medications were recorded, so a nonparametric analysis was applied.||0.2|-0.1|0.25
73850167|NCT00200967|147246967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.34||95.0|-0.1|0.03|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.03|-0.10|0.34
73850168|NCT00200967|147246968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.91||95.0|-0.08|0.07|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.07|-0.08|0.91
73850169|NCT00200967|147246969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|7.0||0.93||95.0|-15.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||14|-15|0.93
74023921|NCT01381094|147600255|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0001
73850170|NCT00200967|147246970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.13||95.0|-0.04|0.31|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for eNO.|A mixed-effects linear model was applied to the natural logarithm of eNO to account for the repeated measurements within each treatment period of the crossover design.||0.31|-0.04|0.13
73850171|NCT00200967|147246971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.24||0.79||95.0|-0.56|0.43|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for EBC.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.43|-0.56|0.79
73850172|NCT00200967|147246972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.45||0.004||95.0|0.43|2.21|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for methacholine PC20.|A mixed-effects linear model was applied to the base-2 logarithm of the methacholine PC20 to account for the repeated measurements within each treatment period of the crossover design.||2.21|0.43|0.004
73850173|NCT00200967|147246973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.89||95.0|-0.23|0.26|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for ACQ.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.26|-0.23|0.89
73850174|NCT01444430|147246982|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the 95% CI of the hazard ratio will be used to assess statistical non-inferiority (non-inferiority margin=2).|Hazard Ratio (HR)|1.073|||||TWO_SIDED|95.0|0.698|1.65|||Regression, Cox|||||1.650|0.698|
73850175|NCT01444430|147246983|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.835||||0.002|TWO_SIDED|95.0|0.745|0.937|||Regression, Cox|||||0.937|0.745|0.002
73850176|NCT01444430|147246984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|3.3|5.4|||ANOVA|||||5.4|3.3|<0.001
73850177|NCT01444430|147246985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.6||0.272|TWO_SIDED|95.0|-0.5|1.7|||ANOVA|||||1.7|-0.5|0.272
73850178|NCT01444430|147246986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||ANOVA|||||-0.1|-0.2|<0.001
73850179|NCT01444430|147246987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.1|-0.06|||ANCOVA|||||-0.06|-0.10|<0.001
73850180|NCT01444430|147246988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.004|TWO_SIDED|95.0|-1.0|-0.2|||ANOVA|||||-0.2|-1.0|0.004
73850181|NCT01444430|147246989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739||||0.095|TWO_SIDED|95.0|0.518|1.055|||Regression, Cox|||||1.055|0.518|0.095
73850182|NCT01530178|147247002|OTHER|Non-specified|Mean Difference (Final Values)|-27.91||||0.003|TWO_SIDED|95.0|-44.7|-11.2|||ANOVA|||||-11.2|-44.7|0.003
73850183|NCT01530178|147247002|OTHER|Non-specified|Mean Difference (Final Values)|-2.131||||0.68|TWO_SIDED|95.0|-12.91|8.652|||ANOVA|||||8.652|-12.91|0.68
73850184|NCT01530178|147247002|OTHER||Mean Difference (Final Values)|-25.78||||0.0005|TWO_SIDED|95.0|-38.39|-13.17|||ANOVA|||||-13.17|-38.39|0.0005
73850185|NCT00276406|147247003|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.||||<0.01
73850186|NCT00276406|147247007|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.||||0.096
73850187|NCT00276406|147247008|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||||||0.02
73850188|NCT00276406|147247009|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.||||0.005
73850189|NCT00276406|147247010|SUPERIORITY_OR_OTHER||||||<|0.04||95.0|||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.||||<0.04
73850190|NCT01537315|147247023|SUPERIORITY_OR_OTHER|||||||0.4521|TWO_SIDED|||||A paired comparison between baseline CRP values with values obtained after 1, 3, and 6 months of treatment was conducted, with a p-value of 0.05 used as the a priori threshold of statistical significance.|ANOVA|||||||0.4521
73850191|NCT02197572|147247025|OTHER||Least Squares Mean|-2.2|||||ONE_SIDED|95.0||2.2||||||Change from Baseline at 0.25 Hours Postdose||2.2||
73850192|NCT02197572|147247025|OTHER||Least Squares Mean|-8.3|||||ONE_SIDED|95.0||-4.0||||||Change from Baseline at 0.5 Hours Postdose||-4.0||
73850193|NCT02197572|147247025|OTHER||Least Squares Mean|-1.8|||||ONE_SIDED|95.0||2.6||||||Change from Baseline at 1 Hour Postdose||2.6||
73850194|NCT02197572|147247025|OTHER||Least Squares Mean|-2.7|||||ONE_SIDED|95.0||1.7||||||Change from Baseline at 1.5 Hours Postdose||1.7||
73850195|NCT02197572|147247025|OTHER||Least Squares Mean|-5.0|||||ONE_SIDED|95.0||-0.6||||||Change from Baseline at 2 Hours Postdose||-0.6||
73850196|NCT02197572|147247025|OTHER||Least Squares Mean|-7.6|||||ONE_SIDED|95.0||-3.2||||||Change from Baseline at 2.5 Hours Postdose||-3.2||
73850197|NCT02197572|147247025|OTHER||Least Squares Mean|-9.1|||||ONE_SIDED|95.0||-4.6||||||Change from Baseline at 3 Hours Postdose||-4.6||
73850198|NCT02197572|147247025|OTHER||Least Squares Mean|-7.2|||||ONE_SIDED|95.0||-2.9||||||Change from Baseline at 4 Hours Postdose||-2.9||
73850199|NCT02197572|147247025|OTHER||Least Squares Mean|-8.8|||||ONE_SIDED|95.0||-4.6||||||Change from Baseline at 6 Hours Postdose||-4.6||
74023922|NCT01381094|147600255|SUPERIORITY||||||=|0.1089|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1089
74023923|NCT01381094|147600255|SUPERIORITY||||||=|0.0833|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0833
73850200|NCT02197572|147247025|OTHER||Least Squares Mean|-2.2|||||ONE_SIDED|95.0||2.4||||||Change from Baseline at 8 Hours Postdose||2.4||
73850201|NCT02197572|147247025|OTHER||Least Squares Mean|-6.6|||||ONE_SIDED|95.0||-0.5||||||Change from Baseline at 10 Hours Postdose||-0.5||
73850202|NCT02197572|147247025|OTHER||Least Squares Mean|7.1|||||ONE_SIDED|95.0||11.4||||||Change from Baseline at 24 Hours Postdose||11.4||
73850203|NCT02197572|147247025|OTHER||Least Squares Mean|2.8|||||ONE_SIDED|95.0||8.1||||||Change from Baseline at 48 Hours Postdose||8.1||
73850204|NCT01484496|147247081|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0006|TWO_SIDED|95.0|1.25|2.25|||Regression, Logistic|||||2.25|1.25|0.0006
73850205|NCT01484496|147247082|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51||||0.0004|TWO_SIDED|95.0|0.35|0.74|||Cox proportional hazards model|||||0.74|0.35|0.0004
73850206|NCT01484496|147247083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0732|TWO_SIDED|95.0|0.95|2.84|||Regression, Logistic|||||2.84|0.95|0.0732
73850207|NCT02553928|147247095|OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.19||0.097|TWO_SIDED|95.0|-0.06|0.69||Based on full analysis set|ANCOVA||The comparison is to BID memantine.|The ADCS-CGIC was analyzed based on an analysis of covariance (ANCOVA) of ADCS-CGIC score at Week 12, with treatment and site as fixed factors, and baseline score as a covariate using observed cases.||0.69|-0.06|0.097
73850208|NCT02933879|147247100|SUPERIORITY|||||||0.4615|||||||Z-test, 2 sided|||||||0.4615
73850209|NCT02933879|147247102|SUPERIORITY|||||||0.0404|||||||Z-test, 2 sided|||||||0.0404
73850210|NCT02933879|147247102|SUPERIORITY|||||||0.2106|||||||Z-test, 2 sided|||||||0.2106
73850211|NCT02933879|147247104|SUPERIORITY|||||||1|||||||Z-test, 2 sided|||||||1.0000
73850212|NCT02933879|147247106|SUPERIORITY|||||||1|||||||Z-test, 2 sided|||||||1.0000
74023924|NCT01381094|147600257|SUPERIORITY||||||=|0.5456|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.5456
73850213|NCT02933879|147247109|SUPERIORITY|||||||0.2467|||||||Z-test, 2 sided|||||||0.2467
73850214|NCT02688192|147247117|SUPERIORITY|||||||0.39|||||||ANOVA|df = 33||Effects of the intervention on changes in the General Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||0.39
73850215|NCT02688192|147247117|SUPERIORITY|||||||0.49|||||||ANOVA|df = 33||Effects of the intervention on changes in the Sleep/Rest Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.49
73850216|NCT02688192|147247117|SUPERIORITY|||||||0.83|||||||ANOVA|df = 33||Effect of the intervention on changes in the Cognitive Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.83
73850217|NCT02688192|147247118|SUPERIORITY|||||||0.98|||||||ANOVA|df = 33||Effects of the intervention on changes in the PedsQL Physical Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.98
73850218|NCT02688192|147247118|SUPERIORITY|||||||0.85|||||||ANOVA|df = 29||Effects of the intervention on changes in the PedsQL Psychosocial Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.85
73850219|NCT02688192|147247119|SUPERIORITY|||||||0.29|||||||ANOVA|df = 29||||||.29
74023925|NCT01381094|147600257|SUPERIORITY||||||=|0.0053|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.0053
74023926|NCT01381094|147600257|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||<0.0001
74023927|NCT01381094|147600257|SUPERIORITY||||||=|0.004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.0040
74023928|NCT01381094|147600257|SUPERIORITY||||||=|0.2017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.2017
74023929|NCT03895203|147600290|SUPERIORITY||Odds Ratio (OR)|7.082|||<|0.001|TWO_SIDED|95.0|4.583|10.943|||Regression, Logistic|||||10.943|4.583|<0.001
74023930|NCT03895203|147600291|SUPERIORITY||Least square (LS) mean difference|-0.187|||<|0.001|TWO_SIDED|95.0|-0.249|-0.125|||ANCOVA|||||-0.125|-0.249|<0.001
73850220|NCT02688192|147247120|SUPERIORITY|||||||0.019|||||||ANOVA|df = 32||Effect of the intervention on changes in lower body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data||||.019
73850221|NCT02688192|147247120|SUPERIORITY|||||||0.34|||||||ANOVA|df = 32||Effect of the intervention on changes in upper body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.34
73850222|NCT00075764|147247122|OTHER||Hazard Ratio (HR)|0.8||||0.007|TWO_SIDED|95.0|0.68|0.94|||Log Rank|Two-sided stratified log-rank test||||0.94|0.68|0.007
73850223|NCT00075764|147247124|OTHER||Hazard Ratio (HR)|0.81||||0.049|TWO_SIDED|95.0|0.65|1.0|||Log Rank|A log-rank test, stratified according to prior or no prior tamoxifen therapy.||||1.00|0.65|0.049
74023931|NCT03895203|147600293|SUPERIORITY||Odds Ratio (OR)|63.039|||<|0.001|TWO_SIDED|95.0|22.211|178.918|||Regression, Logistic|||||178.918|22.211|<0.001
73850224|NCT01773967|147247144|SUPERIORITY|||||||0.83|||||||Mantel Haenszel|||||||0.83
73850225|NCT01773967|147247146|SUPERIORITY|||||||0.26|||||||Van Elteren's modification Mann-Whitney|||||||0.26
73850226|NCT01135459|147247147|OTHER||Odds Ratio (OR)|0.7649||||0.3989|TWO_SIDED|95.0|0.4|1.4|||Regression, Logistic|||Analysis was performed using a logistic regression model with treatment and stratification factors as main factors.||1.4|0.4|0.3989
73850227|NCT01194219|147247158|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.8|||<|0.0001|TWO_SIDED|95.0|23.1|32.5|||Chi-squared|||||32.5|23.1|<0.0001
73850228|NCT01194219|147247159|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||<|0.0001|TWO_SIDED|95.0|13.7|21.9|||Chi-squared|||||21.9|13.7|<0.0001
73850229|NCT01194219|147247160|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-40.78|||<|0.0001|TWO_SIDED|95.0|-46.34|-35.21|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-35.21|-46.34|<0.0001
73850230|NCT01194219|147247161|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-35.3|||<|0.0001|TWO_SIDED|95.0|-39.9|-30.6|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-30.6|-39.9|<0.0001
73850231|NCT01194219|147247162|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|41.7|||<|0.0001|TWO_SIDED|95.0|35.7|47.7|||Chi-squared|||||47.7|35.7|<0.0001
73850232|NCT01194219|147247163|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-24.2|||<|0.0001|TWO_SIDED|95.0|-28.7|-19.8|||ANOVA|Based on an analysis of variance model for the change from baseline at Week 16, with treatment group as a factor (an ANOVA model).||||-19.8|-28.7|<0.0001
73850233|NCT01194219|147247164|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.4|-3.6|||ANOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor, the baseline value, and the treatment by baseline interaction term as covariates.|||-3.6|-5.4|<0.0001
74023932|NCT03895203|147600294|SUPERIORITY||LS mean difference|4.337|||<|0.001|TWO_SIDED|95.0|3.229|5.444|||ANCOVA|||||5.444|3.229|<0.001
74023933|NCT03895203|147600295|SUPERIORITY||Odds Ratio (OR)|5.447|||<|0.001|TWO_SIDED|95.0|3.668|8.088|||Regression, Logistic|||||8.088|3.668|<0.001
74023934|NCT03895203|147600296|SUPERIORITY||LS mean difference|-0.327||||0.001|TWO_SIDED|95.0|-0.524|-0.13|||ANOVA|||||-0.130|-0.524|0.001
74023935|NCT03895203|147600297|SUPERIORITY||Odds Ratio (OR)|1.904||||0.008|TWO_SIDED|95.0|1.18|3.074|||Regression, Logistic|||||3.074|1.180|0.008
74023936|NCT03895203|147600298|SUPERIORITY||Odds Ratio (OR)|3.437||||0.002|TWO_SIDED|95.0|1.559|7.574|||Regression, Logistic|||||7.574|1.559|0.002
74023937|NCT03895203|147600300|SUPERIORITY||LS mean difference|-0.281||||0.001|TWO_SIDED|95.0|-0.452|-0.111|||ANCOVA|||||-0.111|-0.452|0.001
74023938|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.562|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.357|0.885||||||Comparison at 6 h post first dose||0.885|0.357|
74023939|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.612|STANDARD_ERROR_OF_MEAN|0.281|||TWO_SIDED|95.0|0.349|1.072||||||Comparison at 12 h post first dose||1.072|0.349|
74023940|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.518|STANDARD_ERROR_OF_MEAN|0.319|||TWO_SIDED|95.0|0.274|0.981||||||Comparison at 18 h post first dose||0.981|0.274|
74023941|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.416|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|0.217|0.796||||||Comparison at 24 h post first dose||0.796|0.217|
74023942|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.517|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|0.262|1.021||||||Comparison at 48 h post first dose||1.021|0.262|
74023943|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.661|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|0.291|1.503||||||Comparison at 72 h post first dose||1.503|0.291|
74023944|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.908|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|95.0|0.366|2.254||||||Comparison at 96 h post first dose||2.254|0.366|
73850234|NCT01194219|147247165|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.08|||<|0.0001|TWO_SIDED|95.0|1.81|4.35|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||4.35|1.81|<0.0001
73850235|NCT01194219|147247166|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.7|||<|0.0001|TWO_SIDED|95.0|12.8|20.7|||Chi-squared|||||20.7|12.8|<0.0001
73850236|NCT01194219|147247167|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.649|||<|0.0001|TWO_SIDED|95.0|1.768|3.969|||Log Rank|||||3.969|1.768|<0.0001
73850237|NCT04474197|147247176|SUPERIORITY||Least Squares (LS) Mean Difference|2.3|||<|0.0001|TWO_SIDED|95.0|1.5|3.1|||Mixed-effects Model for Repeated Measure|||||3.1|1.5|<0.0001
73850238|NCT04474197|147247176|SUPERIORITY||LS Mean Difference|2.3|||<|0.0001|TWO_SIDED|95.0|1.6|3.1|||Mixed-effects Model for Repeated Measure|||||3.1|1.6|<0.0001
73850239|NCT04474197|147247176|SUPERIORITY||LS Mean Difference|2.2|||<|0.0001|TWO_SIDED|95.0|1.5|2.9|||Mixed-effects Model for Repeated Measure|||||2.9|1.5|<0.0001
73850240|NCT04474197|147247178|SUPERIORITY||LS Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.4|4.6|||Mixed-effects Model for Repeated Measure|||||4.6|2.4|<0.0001
73850241|NCT04474197|147247178|SUPERIORITY||LS Mean Difference|3.0|||<|0.0001|TWO_SIDED|95.0|1.9|4.0|||Mixed-effects Model for Repeated Measure|||||4.0|1.9|<0.0001
73850242|NCT04474197|147247178|SUPERIORITY||LS Mean Difference|2.7|||<|0.0001|TWO_SIDED|95.0|1.8|3.7|||Mixed-effects Model for Repeated Measure|||||3.7|1.8|<0.0001
74023945|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.768|STANDARD_ERROR_OF_MEAN|0.195|||TWO_SIDED|95.0|0.52|1.134||||||Comparison at 6 h post first dose||1.134|0.520|
74023946|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.701|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|0.427|1.15||||||Comparison at 12 h post first dose||1.150|0.427|
73850243|NCT00363142|147247213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of FPV/r100 to FPV/r200 would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in percentage of participants not meeting the virologic failure definition \[FPV/r100 minus FPV/r200\] was -12% or greater.|Difference in the percentages|-2.12||||||95.0|-9.36|5.12|||||Difference in percentages = percentage in Arm 1 minus percentage in Arm 2|||5.12|-9.36|
73850244|NCT00132301|147247244|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.4|TWO_SIDED|95.0|0.58|1.11||Log rank test stratified by site.|Log Rank|||||1.11|0.58|0.40
73850245|NCT02012218|147247245|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values were calculated according to testing a null hypothesis of zero mean change.|Mixed Models Analysis|This analysis was conducted using a mixed model repeated measures analysis on observed case data.||The null hypothesis of zero in mean change from baseline in MADRS total score at Week 6 was tested for each treatment group at significance level of 0.05 (2-sided).||||<0.0001
73850246|NCT00480740|147247264|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of dexmedetomindine plus sevoflurane compared with the baseline (sevoflurane alone) for any given variable was reached when the difference (steady-state \[dexmedetomidine + sevoflurane\]-baseline \[sevoflurane0\]/baseline \[sevoflurane\]0 and its associated 95% confidence interval (CI) fell completely withing the range of +/-20% indicated by the gray column.||||||0.05||95.0||||The original study design was powered to achieve at least 80% power to detect noninferiority with the two-tailed alpha level set at 0.05 for data with two measurements.|t-test, 2 sided|||||||0.05
73850247|NCT01890265|147247278|SUPERIORITY||LS mean difference|4.33|||=|0.0331|TWO_SIDED|95.0|0.35|8.3||The analysis of the change from Baseline to Week 48 in FVC (% predicted) was based on the random coefficient regression model based on observed cases.|Random coefficient regression|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in FVC (% predicted) is presented.||8.3|0.35|= 0.0331
73850248|NCT01890265|147247279|SUPERIORITY||LS mean difference|-1.8|||=|0.0236|TWO_SIDED|95.0|-3.3|-0.2|||ANCOVA with MI|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 24 in QLF score is presented.||-0.2|-3.3|= 0.0236
73850249|NCT01890265|147247279|SUPERIORITY||LS mean difference|-3.2|||=|0.0729|TWO_SIDED|95.0|-6.6|0.3|||ANCOVA with MI|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in QLF score is presented.||0.3|-6.6|= 0.0729
73850250|NCT01890265|147247280|SUPERIORITY||Absolute difference|-21.4|||=|0.0133|TWO_SIDED|95.0|-36.6|-6.2|||Regression, Logistic|||The absolute treatment difference (pamrevlumab - placebo) for percentage of participants with IPF progression at Week 48 is presented.||-6.2|-36.6|= 0.0133
73850251|NCT02881775|147247327|SUPERIORITY|||||||0.9994||||||The threshold for significance was P \<.05|ANOVA|"Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors.~Degrees of freedom (DF) = 34.1"||Comparison of CAR BL Change (treatment by time)||||.9994
73850252|NCT02881775|147247328|SUPERIORITY|||||||0.9768||||||The threshold for statistical significance was p \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of MVIC BL Change (treatment by time)||||.9768
73850253|NCT02881775|147247329|SUPERIORITY|||||||0.444||||||threshold for statistical significance is p \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 43.1||Comparison of NPRS BL Change (treatment by time)||||0.4440
73850254|NCT02881775|147247330|SUPERIORITY|||||||0.6608||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||PPT BL Change (treatment by time)||||.6608
73850255|NCT02881775|147247331|SUPERIORITY|||||||0.7706||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of TUG BL Change (treatment by time)||||.7706
73850256|NCT02881775|147247332|SUPERIORITY|||||||0.3665||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of AMT-MEP BL Change (treatment by time)||||.3665
74023947|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.578|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.329|1.015||||||Comparison at 18 h post first dose||1.015|0.329|
74023948|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.41|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|95.0|0.231|0.728||||||Comparison at 24 h post first dose||0.728|0.231|
74023949|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.896|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|0.484|1.657||||||Comparison at 48 h post first dose||1.657|0.484|
73850257|NCT02881775|147247333|SUPERIORITY|||||||0.3889||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of SICI BL Change (treatment by time)||||.3889
73850258|NCT02881775|147247334|SUPERIORITY|||||||0.2192||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of ICF BL Change (treatment by time)||||.2192
73850259|NCT01166347|147247335|NON_INFERIORITY|The non-inferiority margin was 15%.|Difference in Percentages|3.7||||0.011|ONE_SIDED|95.0||12.56|||Wald test||Difference = Control - HeartWare|Primary endpoint is 2 year survival free from disabling stroke (Modified Rankin Scale \>=4), death, exchange, explant due to device malfunction or urgent transplantation. Subjects who are electively transplanted or explanted due to recovery (no disabling stroke) must survive to 2 years post original implant to be considered a success.||12.56||0.0110
73850260|NCT01166347|147247336|SUPERIORITY||Difference in Percentages|1.1||||0.5922|TWO_SIDED|95.0|-8.5|10.8||If p\<0.05, then the test is statistically significant.|Regression, Logistic|Treatment as the only independent variable.|Difference = HeartWare - Control|If non-inferiority is established for the primary endpoint, statistical testing for superiority and p-value estimation for the 3 secondary endpoints (incidence of bleeding, incidence of major infection, overall survival) will be performed in a pre-specified sequence and testing will continue at the nominal alpha level until the first non-significant result. This fixed sequence procedure strongly controls the family-wise error rate for the collection of the 3 secondary endpoints.||10.8|-8.5|0.5922
73850261|NCT03541499|147247366|SUPERIORITY|||||||0.807|||||||Barnard's exact test|||At any time point||||0.807
73850262|NCT03541499|147247366|SUPERIORITY|||||||0.043|||||||Barnard's exact test|||At any time point||||0.043
73971027|NCT04119843|147482210|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|1.059|<|0.001|TWO_SIDED|95.0|0.464|1.054|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 2||1.054|0.464|<0.001
74023950|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.739|STANDARD_ERROR_OF_MEAN|0.374|||TWO_SIDED|95.0|0.35|1.563||||||Comparison at 72 h post first dose||1.563|0.350|
73850263|NCT03541499|147247367|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
73850264|NCT03541499|147247367|SUPERIORITY|||||||0.301|||||||Barnard's exact test|||Any time point||||0.301
73850265|NCT03541499|147247368|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
73850266|NCT03541499|147247368|SUPERIORITY|||||||0.009|||||||Barnard's exact test|||Any time point||||0.009
73850267|NCT03541499|147247370|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgA, any time point||||0.526
73850268|NCT03541499|147247370|SUPERIORITY|||||||0.1|||||||Barnard's exact test|||IgA, any time point||||0.100
73850269|NCT03541499|147247370|SUPERIORITY|||||||0.055|||||||Barnard's exact test|||IgG, any time point||||0.055
73850270|NCT03541499|147247370|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgG, any time point||||0.023
73850271|NCT03541499|147247371|SUPERIORITY|||||||0.174|||||||Barnard's exact test|||IgA, any time point||||0.174
73850272|NCT03541499|147247371|SUPERIORITY|||||||0.006|||||||Barnard's exact test|||IgA, any time point||||0.006
73850273|NCT03541499|147247371|SUPERIORITY|||||||0.745|||||||Barnard's exact test|||IgG, any time point||||0.745
73850274|NCT03541499|147247371|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgG, any time point||||0.023
73850275|NCT03541499|147247377|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgA, any time point||||0.023
73850276|NCT03541499|147247377|SUPERIORITY|||||||0.142|||||||Barnard's exact test|||IgA, any time point||||0.142
73850277|NCT03541499|147247377|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgG, any time point||||0.526
73850278|NCT03541499|147247377|SUPERIORITY|||||||0.142|||||||Barnard's exact test|||IgG, any time point||||0.142
73850279|NCT03541499|147247378|SUPERIORITY|||||||0.836|||||||Barnard's exact test|||IgA, any time point||||0.836
73850280|NCT03541499|147247378|SUPERIORITY|||||||1|||||||Barnard's exact test|||IgA, any time point||||1.000
73850281|NCT03541499|147247378|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgG, any time point||||0.526
73850282|NCT03541499|147247378|SUPERIORITY|||||||0.119|||||||Barnard's exact test|||IgG, any time point||||0.119
73850283|NCT03541499|147247379|SUPERIORITY|||||||0.271|||||||Barnard's exact test|||Any time point||||0.271
73850284|NCT03541499|147247379|SUPERIORITY|||||||0.226|||||||Barnard's exact test|||Any time point||||0.226
73850285|NCT03541499|147247380|SUPERIORITY|||||||0.783|||||||Barnard's exact test|||Any time point||||0.783
73850286|NCT03541499|147247380|SUPERIORITY|||||||0.001|||||||Barnard's exact test|||Any time point||||0.001
74084730|NCT03653026|147722723|SUPERIORITY||LS Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|4.19|7.73||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|||7.73|4.19|<0.001
73850287|NCT03541499|147247381|SUPERIORITY|||||||0.745|||||||Barnard's exact test|||Any time point||||0.745
73850288|NCT03541499|147247381|SUPERIORITY|||||||0.068|||||||Barnard's exact test|||Any time point||||0.068
73850289|NCT03541499|147247382|SUPERIORITY|||||||0.585|||||||Barnard's exact test|||Any time point||||0.585
73961639|NCT01616459|147459803|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|11.22|||||TWO_SIDED|95.8|7.22|16.49||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.||16.49|7.22|
73961640|NCT01616459|147459803|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|3.75|||||TWO_SIDED|95.8|1.03|7.57||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.||7.57|1.03|
73961641|NCT03394885|147459829|OTHER||Exact Binomial Confidence Interval|83.0|||||TWO_SIDED|95.0|66.0|100.0||||||||100|66|
73961642|NCT02515305|147459842|EQUIVALENCE|provides 85% power of success|equivalence ratio|97.54|||||TWO_SIDED|90.0|94.6|104.7||No p-value calculated, just a T/R ratio and 90% confidence interval for the bioequivalence analysis|Fieller's method|||||104.7|94.6|
73961643|NCT02515305|147459843|EQUIVALENCE|provides 85% power of success|Equivalence ratio|100.1|||||TWO_SIDED|90.0|96.0|109.3|||Fieller's method|||||109.3|96|
73961644|NCT03949335|147459849|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
73961645|NCT03949335|147459850|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
73961646|NCT03949335|147459851|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
73961647|NCT03949335|147459852|NON_INFERIORITY|Noninferiority margin equals -0.1|Mean Difference (Final Values)|-0.031|||||TWO_SIDED|95.0|-0.053|-0.01||Success criteria was evaluated using lower confidence interval. No P-Value was calculated.||||||-0.010|-0.053|
73961648|NCT03949335|147459854|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73961649|NCT00801983|147459857|SUPERIORITY_OR_OTHER||||||>|0.05|||||||GEE|||Subjects were compared across keyboard types - The percentage of subjects with MSD when using the alternative keyboard were compared to the % of subjects with MSD when they were using the typical keyboard||||>.05
73961650|NCT03149991|147459860|SUPERIORITY|The unstructured covariance matrix structure was used to model nesting of observations within persons. Non-significant site interaction effects were removed one at a time. Least squares means estimates of the linear fixed effects model on SDQ change scores, adjusting for baseline covariates was used to test the primary hypothesis via contrast statements.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.15||0.46|TWO_SIDED||||||Mixed Models Analysis|Because sample sizes per site varied substantially, we used the Kenward-Roger degrees of freedom method.|degrees of freedom = 44.5; t=-0.74|SDQ total was primary outcome \& Day 14 primary endpoint. Change from baseline was calculated for each person at each follow-up. Change score was the dependent variable in a linear fixed effects model, where a (-)number = less severe depression. For group comparison, treatment was coded as 1 \& placebo as 0, thus a (-)value means treatment doing better. Fixed effects: group(brex v placebo), day(1-28), site(6 sites). All 2-\& 3-way interactions were included, as well as a priori defined covariates.||||0.46
73961651|NCT03149991|147459860|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.11||0.04|TWO_SIDED||||||Mixed Models Analysis||Degrees of freedom = 41.3; t=2.07.|Secondary Aim: To evaluate the short-term effect of brexpiprazole, as measured by the Symptoms of Depression Questionnaire (SDQ), on Day 2. We used the same model as in Aim 1 to test this hypothesis.||||0.04
73961652|NCT03149991|147459860|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.21||0.92|TWO_SIDED||||||Mixed Models Analysis||Degrees of freedom=38.2; t=0.10.|To evaluate the long-term effect of brexpiprazole as measured by the Symptoms of Depression Questionnaire (SDQ) on Day 28. The same model as was used in Aim 1 was used to test this hypothesis.||||0.92
73961653|NCT03149991|147459861|SUPERIORITY||Chi-squared test|0.51||||0.47|TWO_SIDED|||||This p-value was not adjusted, however there were adjustments when using a logistic regression in Statistical Analysis #2.|Chi-squared|||We used a Chi-squared test to assess differences between treatment and control in terms of percent of participants achieving a long-term sustained response, as measured by achieving a 50% or greater reduction on the MADRS on Day 28.||||0.47
73850290|NCT03541499|147247382|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
73850291|NCT01402869|147247387|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||LSD post hoc test was used for multiple group comparisons. P\<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in peak methemoglobin blood levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
73850292|NCT01402869|147247387|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
73850293|NCT01402869|147247387|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
73850294|NCT01402869|147247387|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.89||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.89
73850295|NCT01402869|147247388|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001|||||||ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in the time frame to peak methemoglobin levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
73850296|NCT01402869|147247388|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.43||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.43
73961654|NCT03149991|147459861|SUPERIORITY||Odds Ratio (OR)|1.83||||0.35|TWO_SIDED|95.0|0.52|6.44|||Regression, Logistic|Adjusted for a priori defined covariates also included in Aim 1.||Logistic regression was used to assess a difference in 50% reduction on the MADRS on Day 28 between groups.||6.44|0.52|0.35
74023951|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.56|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|0.659|3.697||||||Comparison at 96 h post first dose||3.697|0.659|
73850297|NCT01402869|147247388|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
73850298|NCT01402869|147247388|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
73850299|NCT01402869|147247389|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||95.0||||P\<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in delta methemoglobin blood levels following the administration prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
73850300|NCT01402869|147247389|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
73850301|NCT01402869|147247389|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
73850302|NCT01402869|147247389|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.92||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.92
73850303|NCT02297815|147247423|SUPERIORITY_OR_OTHER||Score difference|-1.4||||0.008|TWO_SIDED|95.0|-2.44|-0.36|||Weighted linear regression|Propensity-score based full matching performed. Average treatment effect weights calculated and applied to a weighted linear regression.|Narrow antibiotics is the reference group. A score difference less than zero indicates that broad spectrum antibiotics are associated with a lower (poorer) health related quality of life score.|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted linear regression.||-0.36|-2.44|0.008
73850304|NCT02297815|147247424|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.4||||0.39|TWO_SIDED|95.0|-3.1|7.9|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||7.9|-3.1|0.39
74023952|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.608|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.433|0.853||||||Comparison at 6 h post first dose||0.853|0.433|
74023953|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.674|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|95.0|0.437|1.039||||||Comparison at 12 h post first dose||1.039|0.437|
74023954|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.613|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|95.0|0.374|1.004||||||Comparison at 18 h post first dose||1.004|0.374|
74023955|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.558|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.338|0.921||||||Comparison at 24 h post first dose||0.921|0.338|
74023956|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.725|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|95.0|0.427|1.23||||||Comparison at 48 h post first dose||1.230|0.427|
74023957|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.73|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|95.0|0.384|1.386||||||Comparison at 72 h post first dose||1.386|0.384|
73961655|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|1.59||0.04|TWO_SIDED|||||Because tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||degrees of freedom = 41.0, t=2.13.|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 2.||||0.04
74023958|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.147|STANDARD_ERROR_OF_MEAN|0.359|||TWO_SIDED|95.0|0.559|2.353||||||Comparison at 96 h post first dose||2.353|0.559|
74023959|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.776|STANDARD_ERROR_OF_MEAN|0.167|||TWO_SIDED|95.0|0.556|1.082||||||Comparison at 6 h post first dose||1.082|0.556|
74023960|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.602|STANDARD_ERROR_OF_MEAN|0.212|||TWO_SIDED|95.0|0.394|0.919||||||Comparison at 12 h post first dose||0.919|0.394|
74023961|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.623|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|0.386|1.007||||||Comparison at 18 h post first dose||1.007|0.386|
74023962|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.429|STANDARD_ERROR_OF_MEAN|0.245|||TWO_SIDED|95.0|0.263|0.7||||||Comparison at 24 h post first dose||0.700|0.263|
74023963|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.502|STANDARD_ERROR_OF_MEAN|0.259|||TWO_SIDED|95.0|0.299|0.842||||||Comparison at 48 h post first dose||0.842|0.299|
74023964|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.479|STANDARD_ERROR_OF_MEAN|0.317|||TWO_SIDED|95.0|0.255|0.903||||||Comparison at 72 h post first dose||0.903|0.255|
74023965|NCT00996840|147600330|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.579|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|95.0|0.281|1.192||||||Comparison at 96 h post first dose||1.192|0.281|
74023966|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.484|STANDARD_ERROR_OF_MEAN|0.219|||TWO_SIDED|95.0|0.312|0.75||||||Comparison at 6 h post first dose||0.750|0.312|
74023967|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.7|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.399|1.229||||||Comparison at 12 h post first dose||1.229|0.399|
74023968|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.681|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|0.37|1.254||||||Comparison at 18 h post first dose||1.254|0.370|
74023969|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.673|STANDARD_ERROR_OF_MEAN|0.302|||TWO_SIDED|95.0|0.368|1.231||||||Comparison at 24 h post first dose||1.231|0.368|
74023970|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.92|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|0.456|1.857||||||Comparison at 48 h post first dose||1.857|0.456|
74023971|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.944|STANDARD_ERROR_OF_MEAN|0.376|||TWO_SIDED|95.0|0.445|2.002||||||Comparison at 72 h post first dose||2.002|0.445|
74023972|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.905|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|95.0|0.476|1.723||||||Comparison at 96 h post first dose||1.723|0.476|
74023973|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.726|STANDARD_ERROR_OF_MEAN|0.199|||TWO_SIDED|95.0|0.488|1.08||||||Comparison at 6 h post first dose||1.080|0.488|
74023974|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.791|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|0.476|1.317||||||Comparison at 12 h post first dose||1.317|0.476|
74023975|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.725|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|95.0|0.417|1.26||||||Comparison at 18 h post first dose||1.260|0.417|
74023976|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.655|STANDARD_ERROR_OF_MEAN|0.273|||TWO_SIDED|95.0|0.379|1.13||||||Comparison at 24 h post first dose||1.130|0.379|
74023977|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.111|STANDARD_ERROR_OF_MEAN|0.323|||TWO_SIDED|95.0|0.583|2.12||||||Comparison at 48 h post first dose||2.120|0.583|
74023978|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.075|STANDARD_ERROR_OF_MEAN|0.346|||TWO_SIDED|95.0|0.539|2.146||||||Comparison at 72 h post first dose||2.146|0.539|
74023979|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.375|STANDARD_ERROR_OF_MEAN|0.313|||TWO_SIDED|95.0|0.735|2.574||||||Comparison at 96 h post first dose||2.574|0.735|
74023980|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.559|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.4|0.783||||||Comparison at 6 h post first dose||0.783|0.400|
74023981|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.83|STANDARD_ERROR_OF_MEAN|0.216|||TWO_SIDED|95.0|0.539|1.277||||||Comparison at 12 h post first dose||1.277|0.539|
74023982|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.987|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|95.0|0.613|1.589||||||Comparison at 18 h post first dose||1.589|0.613|
74023983|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.924|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|0.582|1.467||||||Comparison at 24 h post first dose||1.467|0.582|
74023984|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.23|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|0.716|2.11||||||Comparison at 48 h post first dose||2.110|0.716|
74023985|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.289|STANDARD_ERROR_OF_MEAN|0.292|||TWO_SIDED|95.0|0.719|2.312||||||Comparison at 72 h post first dose||2.312|0.719|
74023986|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.752|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|95.0|1.053|2.916||||||Comparison at 96 h post first dose||2.916|1.053|
74023987|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.58|STANDARD_ERROR_OF_MEAN|0.163|||TWO_SIDED|95.0|0.419|0.803||||||Comparison at 6 h post first dose||0.803|0.419|
74023988|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.657|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|95.0|0.433|0.996||||||Comparison at 12 h post first dose||0.996|0.433|
74023989|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.747|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|95.0|0.477|1.171||||||Comparison at 18 h post first dose||1.171|0.477|
74023990|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.657|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|95.0|0.421|1.024||||||Comparison at 24 h post first dose||1.024|0.421|
74023991|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.759|STANDARD_ERROR_OF_MEAN|0.261|||TWO_SIDED|95.0|0.451|1.279||||||Comparison at 48 h post first dose||1.279|0.451|
74023992|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.968|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.55|1.701||||||Comparison at 72 h post first dose||1.701|0.550|
74023993|NCT00996840|147600331|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.744|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.45|1.229||||||Comparison at 96 h post first dose||1.229|0.450|
73850305|NCT02297815|147247425|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.5||||0.59|TWO_SIDED|95.0|-3.9|6.8|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||6.8|-3.9|0.59
73850306|NCT02297815|147247426|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|||<|0.001|TWO_SIDED|95.0|7.3|17.2|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||17.2|7.3|<0.001
73850307|NCT02297815|147247427|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.9||||0.09|TWO_SIDED|95.0|-0.8|10.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||10.6|-0.8|0.09
73850308|NCT02297815|147247428|SUPERIORITY||Risk Difference (RD)|4.6||||0.07|TWO_SIDED|95.0|-0.3|9.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||9.6|-0.3|0.07
73850309|NCT00600106|147247446|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.36|||||||t-test (nonparametric Wilcoxon test)|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.36
73850310|NCT00600106|147247447|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.93
73850311|NCT00600106|147247448|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.77|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.77
73850312|NCT00600106|147247450|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.38|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.38
73850313|NCT00600106|147247454|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test (nonparametric Wilcoxon test)|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated. All tests were two-sided with p values \<0.05."||||0.17
73850314|NCT00600106|147247455|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.49
73850315|NCT00600106|147247456|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.77
73850316|NCT00600106|147247457|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.40
73850317|NCT00600106|147247458|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.99
73850318|NCT00600106|147247459|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.21
73850319|NCT00252512|147247460|SUPERIORITY||||||<|0.001||||||Above is calculated p value, a priori threshold for significance set at \<.05|GEE full factorial modeling|||||||<.001
73850320|NCT00252512|147247461|SUPERIORITY|||||||0.015||||||a priori threshold of \<.05|t-test, 2 sided|||8 week analysis||||.015
73850321|NCT00252512|147247461|SUPERIORITY|||||||0.45||||||a priori threshold of \<.05|t-test, 2 sided|||6 month analysis||||0.45
73850322|NCT00252512|147247461|SUPERIORITY|||||||0.0497||||||a prior threshold of .05|t-test, 2 sided|||12 month analysis||||.0497
73961656|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|2.94||0.73|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 44.2, t=-0.35|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 14.||||0.73
73971028|NCT04119843|147482210|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.59|STANDARD_DEVIATION|0.609|<|0.001|TWO_SIDED|95.0|0.429|0.747|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 3||0.747|0.429|<0.001
74023994|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.773|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|0.607|0.985||||||Comparison at 6 h post first dose||0.985|0.607|
74023995|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.795|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|95.0|0.583|1.084||||||Comparison at 12 h post first dose||1.084|0.583|
74023996|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.778|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|0.533|1.135||||||Comparison at 18 h post first dose||1.135|0.533|
74023997|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.633|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|95.0|0.43|0.931||||||Comparison at 24 h post first dose||0.931|0.430|
74023998|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.662|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|0.397|1.103||||||Comparison at 48 h post first dose||1.103|0.397|
74023999|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.465|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|95.0|0.286|0.756||||||Comparison at 72 h post first dose||0.756|0.286|
74024000|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.525|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|95.0|0.295|0.935||||||Comparison at 96 h post first dose||0.935|0.295|
73961657|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-2.86|STANDARD_ERROR_OF_MEAN|3.16||0.37|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df =44.8, t=-0.91|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 28.||||0.37
73961658|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|0.85||0.06|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||degrees of freedom = 40.3, t=1.94.|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 2.||||0.06
73961659|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.06||0.83|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 44.2, t=-0.22|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 14.||||0.83
73961660|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|1.2||0.52|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df =44.0, t=-0.64|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 28.||||0.52
74024001|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.952|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.768|1.18||||||Comparison at 6 h post first dose||1.180|0.768|
73850323|NCT00252512|147247462|SUPERIORITY||||||>|0.05||||||a priori threshold \<.05|Estimation Equation mean modeling|||Costs for period between 6 month follow-up and 12 month follow up.||||>.05
73850324|NCT00252512|147247462|SUPERIORITY||||||>|0.05|||||||Estimating Equation mean modeling|||Costs for period between 6 month follow up and 12 month follow up.||||>.05
73850325|NCT00252512|147247463|SUPERIORITY|||||||0.28||||||a priori threshold \<.05|Chi-squared|||Analysis for 8 week follow up||||.28
73850326|NCT00252512|147247463|SUPERIORITY|||||||0.013||||||A priori threshold \<.05|Chi-squared|||Analysis for 6 month follow up||||.013
73850327|NCT00252512|147247463|SUPERIORITY|||||||0.76||||||A priori threshold \<.05|Chi-squared|||Analysis for 12 month follow up||||.76
73850328|NCT00252512|147247464|SUPERIORITY|||||||0.66||||||A priori threshold \<.05|Chi-squared|||Analysis for 8 week follow-up||||.66
73850329|NCT00252512|147247464|SUPERIORITY|||||||0.37||||||A priori threshold \<.05|Chi-squared|||Analysis for 6 month follow up.||||.37
73850330|NCT00252512|147247464|SUPERIORITY|||||||0.19||||||a priori threshold \<.05|Chi-squared|||Analysis for 12 month follow up.||||.19
73850331|NCT00252512|147247465|SUPERIORITY|||||||0.05||||||A priori threshold of \<.05|Chi-squared|||Analysis for 8 week follow-up||||.05
73850332|NCT00252512|147247465|SUPERIORITY|||||||0.8||||||A priori threshold of \<.05|Chi-squared|||Analysis for 6 month follow-up.||||.80
73850333|NCT00252512|147247465|SUPERIORITY|||||||0.12||||||A priori threshold of \<.05|Chi-squared|||Analysis for 12 month follow-up.||||.12
73850334|NCT01061723|147247466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.966|TWO_SIDED|95.0|0.4|2.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||Sarilumab group was compared to placebo group. Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived.||2.5|0.4|0.966
74024002|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.965|STANDARD_ERROR_OF_MEAN|0.137|||TWO_SIDED|95.0|0.733|1.269||||||Comparison at 12 h post first dose||1.269|0.733|
73850335|NCT01061723|147247466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.467|TWO_SIDED|95.0|0.6|3.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||3.5|0.6|0.467
73850336|NCT01061723|147247466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.559|TWO_SIDED|95.0|0.3|1.9||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||1.9|0.3|0.559
73850337|NCT01061723|147247466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.496|TWO_SIDED|95.0|0.6|3.4||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||3.4|0.6|0.496
73850338|NCT01061723|147247466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.143|TWO_SIDED|95.0|0.8|4.2||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||4.2|0.8|0.143
73850339|NCT03783962|147247480|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||.003
73850340|NCT03783962|147247481|SUPERIORITY|||||||0.97|||||||Mixed Models Analysis|||||||.97
73850341|NCT03783962|147247482|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||.08
73850342|NCT03783962|147247482|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73850343|NCT03783962|147247482|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73850344|NCT03783962|147247483|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||.18
73850345|NCT03783962|147247483|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||.40
73850346|NCT03783962|147247483|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||.01
73850347|NCT03783962|147247484|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||.40
73850348|NCT03783962|147247484|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73850349|NCT03783962|147247484|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73850350|NCT03783962|147247485|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||.25
73850351|NCT03783962|147247485|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73850352|NCT03783962|147247485|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
74024003|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.992|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.71|1.387||||||Comparison at 18 h post first dose||1.387|0.710|
74024004|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.913|STANDARD_ERROR_OF_MEAN|0.171|||TWO_SIDED|95.0|0.649|1.285||||||Comparison at 24 h post first dose||1.285|0.649|
73850353|NCT03783962|147247486|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|||||||.26
73850354|NCT03783962|147247486|SUPERIORITY|||||||0.41|||||||Mixed Models Analysis|||||||.41
73850355|NCT03783962|147247486|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||.02
73850356|NCT03783962|147247487|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||.03
73850357|NCT03783962|147247487|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||.02
73850358|NCT03783962|147247487|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73850359|NCT03783962|147247488|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||.58
73850360|NCT03783962|147247488|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
73850361|NCT03783962|147247488|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||.01
73850362|NCT03783962|147247489|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
73850363|NCT03783962|147247490|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
73850364|NCT03458325|147247491|SUPERIORITY||Mean Difference (Final Values)|-16.0|||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||-11,802.70|-22,187.90|<0.0001
73850365|NCT03458325|147247492|SUPERIORITY||Percentage Difference|-6.4||||0.6765|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||0.6765
73850366|NCT03458325|147247493|SUPERIORITY||Mean Difference (Net)|5.3||||0.5856|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||0.5856
73850367|NCT03458325|147247494|SUPERIORITY||Mean Difference (Net)|-1.9||||1|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||1.000
73850368|NCT03458325|147247495|SUPERIORITY||Mean Difference (Net)|65.1|||<|0.0001|TWO_SIDED||||||Chi-squared|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||<0.0001
73850369|NCT03458325|147247496|SUPERIORITY||Mean Difference (Net)|12.8||||0.0443|TWO_SIDED|95.0|0.4|25.3|||t-test, 2 sided|P-value was obtained from the paired t-test statistic.||Analysis for Summary Score||25.3|0.4|0.0443
73850370|NCT03458325|147247497|SUPERIORITY|Statistical Analysis for the mean change in NT-proBNP over 30 days|Mean Difference (Final Values)|-122.6||||0.5133|TWO_SIDED|95.0|-525.8|280.5|||t-test, 2 sided|||||280.5|-525.8|0.5133
73850371|NCT03458325|147247497|SUPERIORITY||Mean Difference (Final Values)|-719.9||||0.042|TWO_SIDED|95.0|-1406.5|-33.2|||t-test, 2 sided|||Statistical Analysis for mean change in BNP over 30 days||-33.2|-1406.5|0.0420
73850372|NCT02956746|147247501|OTHER|||||||0.4187||||||threshold for significance p-values \< 0.05|ANOVA|||||||0.4187
73850373|NCT00460655|147247510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.428||||0.006||95.0|-5.841|-1.016|||t-test, 2 sided|||||-1.016|-5.841|0.006
73850374|NCT02621476|147247548|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73850375|NCT00131352|147247588|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|The repeated measures ANCOVA model included terms for treatment, site, time and time-by-treatment interaction; the baseline score was a covariate.||||||0.047
73850376|NCT00131352|147247589|SUPERIORITY_OR_OTHER|||||||0.064||95.0|||||ANCOVA|||||||0.064
73850377|NCT00131352|147247590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.022|TWO_SIDED|95.0|0.35|0.92|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using WOMAC A1 data at Week 26.||0.92|0.35|0.022
74024005|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.66|STANDARD_ERROR_OF_MEAN|0.233|||TWO_SIDED|95.0|0.415|1.051||||||Comparison at 48 h post first dose||1.051|0.415|
74024006|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.69|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|0.445|1.072||||||Comparison at 72 h post first dose||1.072|0.445|
74024007|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.724|STANDARD_ERROR_OF_MEAN|0.268|||TWO_SIDED|95.0|0.423|1.239||||||Comparison at 96 h post first dose||1.239|0.423|
74024008|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.95|STANDARD_ERROR_OF_MEAN|0.093|||TWO_SIDED|95.0|0.789|1.144||||||Comparison at 6 h post first dose||1.144|0.789|
74024009|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.985|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|95.0|0.777|1.249||||||Comparison at 12 h post first dose||1.249|0.777|
74024010|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.067|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|95.0|0.797|1.428||||||Comparison at 18 h post first dose||1.428|0.797|
73850378|NCT00131352|147247591|SUPERIORITY_OR_OTHER|||||||0.679||95.0|||||ANCOVA|||||||0.679
73850379|NCT00131352|147247592|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANCOVA|||||||0.266
73850380|NCT00131352|147247593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.005|TWO_SIDED|95.0|0.31|0.82|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using PTGA data at Week 26.||0.82|0.31|0.005
73850381|NCT00131352|147247594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.025|TWO_SIDED|95.0|0.34|0.93|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using COGA data at Week 26.||0.93|0.34|0.025
73850382|NCT00131352|147247595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.156|TWO_SIDED|95.0|0.41|1.16|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using Responder classification data at Week 26.||1.16|0.41|0.156
73850383|NCT02440139|147247603|SUPERIORITY||difference in sensitivity|-0.124|STANDARD_DEVIATION|0.034|<|0.05|TWO_SIDED|95.0|-0.186|-0.062|||Mixed Models Analysis|||||-0.062|-0.186|<0.05
73850384|NCT02440139|147247604|SUPERIORITY||Difference in LROC curves|-0.14|STANDARD_DEVIATION|0.039|<|0.05|TWO_SIDED|95.0|-0.209|-0.071|||ANOVA|||For each study arm, the difference in the least-squares means of the two arms was estimated. A two-sided 95% confidence interval on this difference in study arms (i.e. unaided minus aided by the software) was used to test the hypothesis that the difference in the area under the LROC curve (AUC). The superiority of ClearRead CT will be concluded if the upper bound of the two-sided 95% confidence interval on the difference is less than zero.||-0.071|-0.209|<0.05
73850385|NCT00770562|147247624|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
73850386|NCT00770562|147247625|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
73850387|NCT00770562|147247626|SUPERIORITY_OR_OTHER|||||||0.015|||||||Fisher Exact|||||||0.015
73850388|NCT01816776|147247627|SUPERIORITY||Risk Difference (RD)|41.0|||<|0.0001|TWO_SIDED|95.0|25.0|54.0||1-sided. p\<0.025 considered significant.|Fisher Exact||Risk difference = Treatment - Control|||54|25|<0.0001
73850389|NCT01816776|147247629|SUPERIORITY||Mean Difference (Net)|-22.8|||<|0.0001|TWO_SIDED|95.0|-29.0|-16.6||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||-16.6|-29.0|<0.0001
73850390|NCT01816776|147247630|SUPERIORITY||Mean Difference (Net)|-25.0|||<|0.0001|TWO_SIDED|95.0|-31.2|-18.7||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-18.7|-31.2|<0.0001
73850391|NCT01816776|147247631|SUPERIORITY||Mean Difference (Net)|-15.2|||<|0.0001|TWO_SIDED|95.0|-21.6|-8.7||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-8.7|-21.6|<0.0001
73850392|NCT01816776|147247632|SUPERIORITY||Mean Difference (Net)|2.4||||0.0244|TWO_SIDED|95.0|-0.4|5.1||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||5.1|-0.4|0.0244
73850393|NCT01816776|147247633|SUPERIORITY||Risk Difference (RD)|55.0|||<|0.0001|TWO_SIDED|95.0|40.0|68.0||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Fisher Exact||Risk difference = Treatment - Control|||68|40|<0.0001
73850394|NCT01816776|147247634|SUPERIORITY||Mean Difference (Net)|-22.7|||<|0.0001|TWO_SIDED|95.0|-28.9|-16.5||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-16.5|-28.9|<0.0001
73850395|NCT01816776|147247635|SUPERIORITY||Mean Difference (Net)|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.5|-2.0||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||-2.0|-5.5|<0.0001
73850396|NCT01057693|147247649|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.32||||0.1221|TWO_SIDED|95.0|-0.74|0.09|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model.||0.09|-0.74|0.1221
73850397|NCT00237666|147247676|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
74024011|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.922|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|0.686|1.239||||||Comparison at 24 h post first dose||1.239|0.686|
73850398|NCT01672879|147247697|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|0.1|||||TWO_SIDED|95.0|-1.2|1.5||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.||1.5|-1.2|
73850399|NCT01672879|147247697|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|0.1|||||TWO_SIDED|95.0|-1.2|1.4||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.||1.4|-1.2|
74024012|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.866|STANDARD_ERROR_OF_MEAN|0.198|||TWO_SIDED|95.0|0.583|1.287||||||Comparison at 48 h post first dose||1.287|0.583|
74024013|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.649|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.444|0.95||||||Comparison at 72 h post first dose||0.950|0.444|
74024014|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.722|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.457|1.14||||||Comparison at 96 h post first dose||1.140|0.457|
74024015|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.897|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|95.0|0.748|1.075||||||Comparison at 6 h post first dose||1.075|0.748|
74024016|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.887|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.703|1.119||||||Comparison at 12 h post first dose||1.119|0.703|
74024017|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.846|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|0.638|1.123||||||Comparison at 18 h post first dose||1.123|0.638|
74024018|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.812|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|95.0|0.609|1.084||||||Comparison at 24 h post first dose||1.084|0.609|
74024019|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.58|STANDARD_ERROR_OF_MEAN|0.194|||TWO_SIDED|95.0|0.394|0.855||||||Comparison at 48 h post first dose||0.855|0.394|
74024020|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.439|STANDARD_ERROR_OF_MEAN|0.188|||TWO_SIDED|95.0|0.301|0.639||||||Comparison at 72 h post first dose||0.639|0.301|
74024021|NCT00996840|147600332|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.451|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|0.285|0.714||||||Comparison at 96 h post first dose||0.714|0.285|
74024022|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.85|STANDARD_ERROR_OF_MEAN|0.137|||TWO_SIDED|95.0|0.646|1.119||||||Comparison at 6 h post first dose||1.119|0.646|
73961661|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.19||0.11|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 31.0, t=1.67|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 2.||||0.11
73961662|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.36||0.98|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=41.1, t=-0.03|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 14.||||0.98
73961663|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.41||0.45|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=46.0, t=-0.76|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 28.||||0.45
73961664|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.29||0.02|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=49.2, t=2.39;|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 2.||||0.02
73961665|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.34||0.07|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=56.8, t=1.85|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 14.||||0.07
74024023|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.072|STANDARD_ERROR_OF_MEAN|0.138|||TWO_SIDED|95.0|0.814|1.411||||||Comparison at 12 h post first dose||1.411|0.814|
74024024|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.08|STANDARD_ERROR_OF_MEAN|0.157|||TWO_SIDED|95.0|0.79|1.478||||||Comparison at 18 h post first dose||1.478|0.790|
74024025|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.951|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|0.715|1.266||||||Comparison at 24 h post first dose||1.266|0.715|
74024026|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.918|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.655|1.285||||||Comparison at 48 h post first dose||1.285|0.655|
74024027|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.012|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.735|1.395||||||Comparison at 72 h post first dose||1.395|0.735|
74024028|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.168|STANDARD_ERROR_OF_MEAN|0.169|||TWO_SIDED|95.0|0.831|1.64||||||Comparison at 96 h post first dose||1.640|0.831|
74024029|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.912|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|95.0|0.713|1.167||||||Comparison at 6 h post first dose||1.167|0.713|
74024030|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.963|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|0.753|1.233||||||Comparison at 12 h post first dose||1.233|0.753|
74024031|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.917|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.693|1.214||||||Comparison at 18 h post first dose||1.214|0.693|
74024032|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.87|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|0.673|1.123||||||Comparison at 24 h post first dose||1.123|0.673|
73850400|NCT01672879|147247698|SUPERIORITY|||||||0.41|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (\< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.||||0.41
74024033|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.141|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|95.0|0.84|1.55||||||Comparison at 48 h post first dose||1.550|0.840|
74024034|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.122|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|95.0|0.837|1.505||||||Comparison at 72 h post first dose||1.505|0.837|
74024035|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.474|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|95.0|1.063|2.045||||||Comparison at 96 h post first dose||2.045|1.063|
74024036|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.833|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.672|1.031||||||Comparison at 6 h post first dose||1.031|0.672|
74024037|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.879|STANDARD_ERROR_OF_MEAN|0.109|||TWO_SIDED|95.0|0.707|1.092||||||Comparison at 12 h post first dose||1.092|0.707|
74024038|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.023|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|0.8|1.307||||||Comparison at 18 h post first dose||1.307|0.800|
74024039|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.95|STANDARD_ERROR_OF_MEAN|0.111|||TWO_SIDED|95.0|0.761|1.187||||||Comparison at 24 h post first dose||1.187|0.761|
74024040|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.968|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|0.743|1.262||||||Comparison at 48 h post first dose||1.262|0.743|
74024041|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.926|STANDARD_ERROR_OF_MEAN|0.127|||TWO_SIDED|95.0|0.718|1.193||||||Comparison at 72 h post first dose||1.193|0.718|
74024042|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.229|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|95.0|0.936|1.613||||||Comparison at 96 h post first dose||1.613|0.936|
74024043|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.923|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|95.0|0.753|1.131||||||Comparison at 6 h post first dose||1.131|0.753|
73850401|NCT01672879|147247698|SUPERIORITY|||||||0.065|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (\< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.||||0.065
73850402|NCT03951766|147247731|SUPERIORITY||Mean Difference (Final Values)|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.1||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||||-1.1|-1.9|<.0001
73850403|NCT03951766|147247732|SUPERIORITY||Median Difference (Final Values)|-24.9|||<|0.0001|TWO_SIDED|95.0|-32.7|-17.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-17.1|-32.7|<.0001
73850404|NCT03951766|147247733|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.06|TWO_SIDED|95.0|0.0|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||PANAS positive affect||0.4|-0.0|0.06
73850405|NCT03951766|147247733|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.36|TWO_SIDED|95.0|-0.4|0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||PANAS negative affect||0.1|-0.4|0.36
73850406|NCT03951766|147247734|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.1627|TWO_SIDED|95.0|-0.1|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.1|0.1627
73850407|NCT03951766|147247735|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.62|TWO_SIDED|95.0|-3.8|6.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||Single-item - past week||6.3|-3.8|0.62
73850408|NCT03951766|147247735|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.83|TWO_SIDED|95.0|-5.4|4.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||Single-item - right now||4.4|-5.4|0.83
73850409|NCT03951766|147247736|SUPERIORITY||Mean Difference (Final Values)|13.1|||<|0.0001|TWO_SIDED|95.0|7.6|18.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||SEQ-12 - Internal||18.7|7.6|<.0001
73850410|NCT03951766|147247736|SUPERIORITY||Mean Difference (Final Values)|11.1|||<|0.0001|TWO_SIDED|95.0|6.1|16.1|||t-test, 2 sided|||SEQ-12 - External||16.1|6.1|<.0001
73850411|NCT03951766|147247737|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.0126|TWO_SIDED|95.0|1.2|9.8||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||9.8|1.2|0.0126
73850412|NCT03951766|147247738|SUPERIORITY||Mean Difference (Final Values)|-6.6||||0.0053|TWO_SIDED|95.0|-11.1|-2.0||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-2.0|-11.1|0.0053
73850413|NCT03951766|147247739|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.76|TWO_SIDED|95.0|-0.1|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||ATS - Adverse Effects||0.2|-0.1|0.76
73850414|NCT03951766|147247739|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||ATS - Psychoactive Benefits||-0.5|-1.0|<.0001
74024044|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.768|STANDARD_ERROR_OF_MEAN|0.103|||TWO_SIDED|95.0|0.625|0.943||||||Comparison at 12 h post first dose||0.943|0.625|
74024045|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.826|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.655|1.042||||||Comparison at 18 h post first dose||1.042|0.655|
74024046|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.761|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|95.0|0.615|0.942||||||Comparison at 24 h post first dose||0.942|0.615|
74024047|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.781|STANDARD_ERROR_OF_MEAN|0.125|||TWO_SIDED|95.0|0.608|1.003||||||Comparison at 48 h post first dose||1.003|0.608|
74024048|NCT00996840|147600333|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.668|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|0.524|0.851||||||Comparison at 72 h post first dose||0.851|0.524|
74024049|NCT00996840|147600333|OTHER||Ratio (Treatment/Placebo)|0.86|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|0.659|1.122||||||Comparison at 96 h post first dose||1.122|0.659|
73961666|NCT03149991|147459862|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.41||0.37|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=50.5, t=0.91|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 28.||||0.37
73961667|NCT03149991|147459866|EQUIVALENCE|The hypothesis was that there would be no group differences in terms of occurrence of abnormal ECGs.|Chi-squared test|0.28||||0.6|TWO_SIDED||||||Chi-squared|||This analysis was to assess group differences (drug vs. placebo) in terms of number of abnormal ECGs out of total ECGs assessed.||||0.60
73961668|NCT03149991|147459866|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at baseline.|Chi-squared test|0.94||||0.33|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at baseline.||||0.33
73961669|NCT03149991|147459866|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 4.|Chi-squared test|0.0||||1|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 4.||||1.00
73961670|NCT03149991|147459866|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 5.|Chi-squared test|0.08||||0.78|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 5.||||0.78
73961671|NCT03149991|147459866|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 6.|Chi-squared test|0.02||||0.9|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 6.||||0.90
73850415|NCT03951766|147247739|SUPERIORITY||Mean Difference (Final Values)|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||ATS - Pleasure||-0.3|-0.8|<.0001
73850416|NCT03951766|147247740|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.25|TWO_SIDED|95.0|-0.3|0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.1|-0.3|0.25
73850417|NCT03951766|147247741|SUPERIORITY|DBI - Positive Experiences|Mean Difference (Final Values)|-20.7|||<|0.0001|TWO_SIDED|95.0|-27.2|-14.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-14.3|-27.2|<.0001
73850418|NCT03951766|147247741|SUPERIORITY|DBI - Negative Experiences|Mean Difference (Final Values)|-2.9||||0.27|TWO_SIDED|95.0|-8.1|2.3||"We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6."|t-test, 2 sided|||||2.3|-8.1|0.27
73850419|NCT03951766|147247742|SUPERIORITY|Pros of Being Smoke-Free|Mean Difference (Final Values)|-9.1||||0.009|TWO_SIDED|95.0|-15.9|-2.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-2.3|-15.9|0.009
73850420|NCT03951766|147247742|SUPERIORITY|Cons of Quitting|Mean Difference (Final Values)|-5.1||||0.25|TWO_SIDED|95.0|-13.7|3.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||3.6|-13.7|0.25
73850421|NCT03951766|147247743|SUPERIORITY|PSS total scores|Mean Difference (Final Values)|-2.4||||0.0069|TWO_SIDED|95.0|-4.1|-0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.7|-4.1|0.0069
73850422|NCT03951766|147247743|SUPERIORITY|PSS - Perceived Helplessness|Mean Difference (Final Values)|-0.3||||0.0043|TWO_SIDED|95.0|-0.5|-0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.1|-0.5|0.0043
73850423|NCT03951766|147247743|SUPERIORITY|PSS - Perceived Self-Efficacy|Mean Difference (Final Values)|0.1||||0.1953|TWO_SIDED|95.0|-0.1|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.1|0.1953
73850424|NCT03951766|147247744|SUPERIORITY|Brief COPE Self-distraction|Mean Difference (Final Values)|0.4||||0.087|TWO_SIDED|95.0|-0.1|0.8||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.8|-0.1|0.087
73850425|NCT03951766|147247744|SUPERIORITY|Brief COPE active coping|Mean Difference (Final Values)|-0.209||||0.2866|TWO_SIDED|95.0|-0.6|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.2|-0.6|0.2866
73850426|NCT03951766|147247744|SUPERIORITY|Brief COPE denial|Mean Difference (Final Values)|0.0||||0.9296|TWO_SIDED|95.0|-0.4|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.4|-0.4|0.9296
73850427|NCT03951766|147247744|SUPERIORITY|Brief COPE substance use|Mean Difference (Final Values)|-0.1||||0.6599|TWO_SIDED|95.0|-0.5|0.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.3|-0.5|0.6599
73850428|NCT03951766|147247744|SUPERIORITY|Brief COPE use of emotional support|Mean Difference (Final Values)|0.3||||0.2315|TWO_SIDED|95.0|-0.2|0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.7|-0.2|0.2315
73850429|NCT03951766|147247744|SUPERIORITY|Brief COPE use of instrumental support|Mean Difference (Final Values)|0.1||||0.6183|TWO_SIDED|95.0|-0.3|0.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.6|-0.3|0.6183
74024050|NCT00363415|147600339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.56|||<|0.01||95.0|1.27|1.92|||Log Rank|||||1.92|1.27|<0.01
74024051|NCT00363415|147600340|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sex: Male|Log Rank|||||||<0.001
73961672|NCT03149991|147459866|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 7.|Chi-squared test|0.63||||0.43|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 7.||||0.43
73850430|NCT03951766|147247744|SUPERIORITY|Brief COPE behavioral disengagement|Mean Difference (Final Values)|0.3||||0.2037|TWO_SIDED|95.0|-0.1|0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.7|-0.1|0.2037
73850431|NCT03951766|147247744|SUPERIORITY|Brief COPE venting|Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.9|-0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.2|-0.9|0.0060
73850432|NCT03951766|147247744|SUPERIORITY|Brief COPE positive reframing|Mean Difference (Final Values)|-0.2||||0.3045|TWO_SIDED|95.0|-0.7|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.2|-0.7|0.3045
73850433|NCT03951766|147247744|SUPERIORITY|Brief COPE planning|Mean Difference (Final Values)|-0.6||||0.0029|TWO_SIDED|95.0|-1.0|-0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.2|-1.0|0.0029
73850434|NCT03951766|147247744|SUPERIORITY|Brief COPE humor|Mean Difference (Final Values)|0.0||||0.8274|TWO_SIDED|95.0|-0.5|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.5|0.8274
73850435|NCT03951766|147247744|SUPERIORITY|Brief COPE acceptance|Mean Difference (Final Values)|0.4||||0.0349|TWO_SIDED|95.0|0.0|0.9||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.9|0.0|0.0349
73850436|NCT03951766|147247744|SUPERIORITY|Brief COPE religion|Mean Difference (Final Values)|0.2||||0.3451|TWO_SIDED|95.0|-0.2|0.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.6|-0.2|0.3451
73850437|NCT03951766|147247744|SUPERIORITY|Brief COPE self-blame|Mean Difference (Final Values)|-0.8||||0.0006|TWO_SIDED|95.0|-1.2|-0.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.3|-1.2|0.0006
73850438|NCT01313910|147247763|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxin-rank test used to determine decrease in bowel movements/day after 8 weeks of intervention||||0.008
73850439|NCT01313910|147247764|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
73850440|NCT01313910|147247765|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73850441|NCT01313910|147247767|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
73850442|NCT00295646|147247768|SUPERIORITY|A two-sided significance level of 2.5% was used in this 2x2 factorial design of two primary endpoints according to the Bonferroni-Holm adjustment to control multiplicity.|Cox Proportional Hazard|1.1||||0.59|TWO_SIDED|95.0|0.78|1.53||Two-sided significance level of 2.5%, with the application of the Bonferroni-Holm adjustment for multiple comparisons|Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter disease-free time for arimidex relative to tamoxifen.|To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.||1.53|0.78|0.59
73850443|NCT00295646|147247769|SUPERIORITY|A two-sided significance level of 2.5% was used in this 2x2 factorial design of two primary endpoints according to the Bonferroni-Holm adjustment to control multiplicity.|Cox Proportional Hazard|0.64||||0.01|TWO_SIDED|95.0|0.46|0.91||Two-sided significance level of 2.5%, with the application of the Bonferroni-Holm adjustment for multiple comparisons|Log Rank||From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for Zoledronic Acid relative to no Zoledronic Acid.|To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.||0.91|0.46|0.01
73850444|NCT00295646|147247770|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|1.11||||0.53|TWO_SIDED|95.0|0.8|1.56|||Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter recurrence-free time for arimidex relative to tamoxifen.|To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.||1.56|0.80|0.53
73850445|NCT00295646|147247771|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|0.65||||0.01|TWO_SIDED|95.0|0.46|0.92|||Log Rank|||To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.|From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer recurrence-free time for Zoledronic Acid relative to no Zoledronic Acid.|0.92|0.46|0.01
74024052|NCT00363415|147600340|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Sex: Female|Log Rank|||||||0.023
73961673|NCT03149991|147459866|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 9.|Chi-squared test|0.09||||0.76|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 9.||||0.76
73850446|NCT00295646|147247772|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|1.8||||0.07|TWO_SIDED|95.0|0.96|3.38|||Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter survival time for arimidex relative to tamoxifen.|To determine the effect of anastrozole (AZ and AC) compared to tamoxifen (TZ and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.||3.38|0.96|0.07
73961674|NCT03149991|147459868|EQUIVALENCE|The hypothesis was that there would be no group differences in number of participants reporting adverse events.|Chi-squared test|0.009||||0.92|TWO_SIDED||||||Chi-squared|||This analysis assessed group differences (drug vs. placebo) in terms of number of participants reporting adverse events.||||0.92
73850447|NCT00295646|147247773|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|0.6||||0.1|TWO_SIDED|95.0|0.32|1.11|||Log Rank||From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer survival time for Zoledronic Acid relative to no Zoledronic Acid.|To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.||1.11|0.32|0.10
73850448|NCT02626156|147247774|SUPERIORITY||Risk Difference (RD)|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.091|TWO_SIDED|95.0|-0.02|0.3|||Chi-squared||Asymptotic standard error was used|||0.3|-0.02|0.091
73850449|NCT02720523|147247791|SUPERIORITY||Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|14.3|51.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||51.0|14.3|<0.001
73850450|NCT02720523|147247791|SUPERIORITY||Response Rate Difference|40.8|||<|0.001|TWO_SIDED|95.0|23.5|58.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||58.1|23.5|<0.001
73850451|NCT02720523|147247791|SUPERIORITY||Response Rate Difference|37.1|||<|0.001|TWO_SIDED|95.0|19.4|54.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||54.9|19.4|<0.001
73850452|NCT02720523|147247791|OTHER|Cochran-Armitage test was conducted for demonstrating a dose response relationship.|||||<|0.001|||||||Cochran-Armitage test|||||||<0.001
73850453|NCT02720523|147247792|SUPERIORITY||Least Squares (LS) Mean Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.693|-0.88|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-0.880|-1.693|<0.001
73850454|NCT02720523|147247792|SUPERIORITY||LS Mean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.005|-1.19|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-1.190|-2.005|<0.001
74024053|NCT00363415|147600340|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Race: Caucasian.|Log Rank|||||||<0.001
74024054|NCT00363415|147600340|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for Race: Non-Caucasian.|Log Rank|||||||0.030
74024055|NCT00363415|147600340|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 0 or 1.|Log Rank|||||||<0.001
74024056|NCT00363415|147600340|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 2.|Log Rank|||||||0.519
74024057|NCT00363415|147600340|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||P-value for Region: United States.|Log Rank|||||||0.084
74024058|NCT00363415|147600340|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Region: European Union.|Log Rank|||||||0.001
74088258|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.13|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.13|<.0001
73961675|NCT03149991|147459869|EQUIVALENCE|The hypothesis was that there would be no difference between the groups in terms of mean number of adverse events per person, among those who reported any adverse events.|Mean Difference (Final Values)|0.24||||0.81|TWO_SIDED||||||t-test, 2 sided|||This analysis assessed group differences (drug vs. placebo) in terms of mean number of adverse events per person, among those who reported any adverse events.||||0.81
73850455|NCT02720523|147247792|SUPERIORITY||LS Mean Difference|-1.62|||<|0.001|TWO_SIDED|95.0|-2.027|-1.216|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-1.216|-2.027|<0.001
73850456|NCT02720523|147247793|SUPERIORITY||LS Mean Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-0.465|-0.144|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.144|-0.465|<0.001
73850457|NCT02720523|147247793|SUPERIORITY||LS Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.505|-0.184|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.184|-0.505|<0.001
73850458|NCT02720523|147247793|SUPERIORITY||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.55|-0.229|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.229|-0.550|<0.001
73850459|NCT02720523|147247794|SUPERIORITY||Response Rate Difference|24.5||||0.007|TWO_SIDED|95.0|7.3|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||41.7|7.3|0.007
73850460|NCT02720523|147247794|SUPERIORITY||Response Rate Difference|49.0|||<|0.001|TWO_SIDED|95.0|32.1|65.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||65.9|32.1|<0.001
73850461|NCT02720523|147247794|SUPERIORITY||Response Rate Difference|41.7|||<|0.001|TWO_SIDED|95.0|24.5|58.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||58.8|24.5|<0.001
73850462|NCT02720523|147247795|SUPERIORITY||Response Rate Difference|18.4||||0.004|TWO_SIDED|95.0|6.4|30.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||30.3|6.4|0.004
73850463|NCT02720523|147247795|SUPERIORITY||Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|18.7|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||46.6|18.7|<0.001
73850464|NCT02720523|147247795|SUPERIORITY||Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|12.9|39.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||39.0|12.9|<0.001
73850465|NCT02720523|147247796|SUPERIORITY||LS Mean Difference|4.33|||<|0.001|TWO_SIDED|95.0|2.1|6.57|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||6.57|2.10|<0.001
73850466|NCT02720523|147247796|SUPERIORITY||LS Mean Difference|3.5||||0.002|TWO_SIDED|95.0|1.25|5.75|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||5.75|1.25|0.002
73850467|NCT02720523|147247796|SUPERIORITY||LS Mean Difference|5.93|||<|0.001|TWO_SIDED|95.0|3.64|8.22|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||8.22|3.64|<0.001
73850468|NCT02720523|147247797|SUPERIORITY||Response Rate Difference|34.7|||<|0.001|TWO_SIDED|95.0|17.0|52.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||52.4|17.0|<0.001
73850469|NCT02720523|147247797|SUPERIORITY||Response Rate Difference|51.0|||<|0.001|TWO_SIDED|95.0|34.2|67.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||67.9|34.2|<0.001
73850470|NCT02720523|147247797|SUPERIORITY||Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|37.1|70.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||70.1|37.1|<0.001
73850471|NCT02720523|147247798|SUPERIORITY||Response Rate Difference|30.6|||<|0.001|TWO_SIDED|95.0|15.5|45.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||45.7|15.5|<0.001
73850472|NCT02720523|147247798|SUPERIORITY||Response Rate Difference|51.0|||<|0.001|TWO_SIDED|95.0|35.6|66.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||66.4|35.6|<0.001
73850473|NCT02720523|147247798|SUPERIORITY||Response Rate Difference|43.9|||<|0.001|TWO_SIDED|95.0|28.5|59.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||59.3|28.5|<0.001
73961676|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared test|0.43||||0.51|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) throughout the trial.||||0.51
73961677|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|2.85||||0.09|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) at Screening.||||0.09
74024059|NCT00363415|147600340|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Region: Intercontinental Region.|Log Rank|||||||0.003
74024060|NCT00363415|147600340|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for LDH (lactate dehydrogenase): \>Upper Limit of Normal.|Log Rank|||||||0.005
73961678|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.004||||0.95|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) at Baseline.||||0.95
73961679|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.005||||0.94|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 1.||||0.94
73961680|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|1.97||||0.16|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 2.||||0.16
73961681|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.44||||0.51|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 5.||||0.51
73850474|NCT02720523|147247799|SUPERIORITY||Response Rate Difference|22.4||||0.006|TWO_SIDED|95.0|7.4|37.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||37.5|7.4|0.006
73850475|NCT02720523|147247799|SUPERIORITY||Response Rate Difference|16.3||||0.026|TWO_SIDED|95.0|2.1|30.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||30.6|2.1|0.026
73961682|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.94||||0.33|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 8.||||0.33
73961683|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.003||||0.96|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 11.||||0.96
73961684|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.5||||0.48|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 14.||||0.48
73961685|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 17.||||0.41
73961686|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.17||||0.68|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 21.||||0.68
74024061|NCT00363415|147600340|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Age: \<=65 years.|Log Rank|||||||<0.001
73850476|NCT02720523|147247799|SUPERIORITY||Response Rate Difference|25.8||||0.002|TWO_SIDED|95.0|10.6|41.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||41.0|10.6|0.002
73961687|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 23.||||0.41
73961688|NCT03149991|147459870|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 28.||||0.41
73961689|NCT05135000|147459885|OTHER||Cox Proportional Hazard|0.7||||0.6843|TWO_SIDED|80.0|0.2|2.8|||Log Rank|||||2.8|0.2|0.6843
73961690|NCT03215927|147459887|SUPERIORITY||Median Difference (Net)|-2.55|STANDARD_ERROR_OF_MEAN|3.34|<|0.05|TWO_SIDED|95.0|-9.36|4.26|||Mixed Models Analysis|Adjustments are for baseline FVC, age, and gender, with a repeated measures effect of participant.|The comparison difference value is µABT - µPlacebo.|The null hypothesis for the change outcomes is µABT - µPlacebo = 0.||4.26|-9.36|<0.05
73961691|NCT03215927|147459888|SUPERIORITY||Hazard Ratio (HR)|0.66|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|TWO_SIDED|95.0|0.16|2.77|||Regression, Cox||ABT is the numerator and Placebo is the denominator for the hazard ratios. The dispersion value given is the SE of the estimate on the natural log scale.|The null hypothesis for the time to event outcomes is exp(bABT) / exp(bPlacebo) = 1.||2.77|0.16|<0.05
74024062|NCT00363415|147600340|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Age: \>65 years.|Log Rank|||||||0.013
74024063|NCT00363415|147600340|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value for Number Metastatic Sites: \<=2.|Log Rank|||||||0.092
73961692|NCT03215927|147459889|SUPERIORITY||Mean Difference (Net)|7.51|STANDARD_ERROR_OF_MEAN|8.12|<|0.05|TWO_SIDED|95.0|-8.8|23.83|||Mixed Models Analysis|Adjustments are for baseline FVC, age, and gender, with a repeated measures effect of participant.|The comparison difference value is µABT - µPlacebo.|The null hypothesis for the change outcomes is µABT - µPlacebo = 0.||23.83|-8.80|<0.05
74024064|NCT00363415|147600340|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Number Metastatic Sites: \>=3.|Log Rank|||||||<0.001
74024065|NCT00363415|147600340|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for History of Brain Metastases: No.|Log Rank|||||||<0.001
74024066|NCT01051739|147600435|SUPERIORITY_OR_OTHER|||||||0.21||||||The a priori threshold of statistical significance is p\<0.05|Kaplan Meyer survival curves|||||||.21
74024067|NCT01440101|147600441|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value obtained from the Mann-Whitney U test stratified by the presence or absence of Gd+ lesions at baseline.|Wilcoxon (Mann-Whitney)|||||||<0.001
73961693|NCT03215927|147459890|SUPERIORITY||Hazard Ratio (HR)|0.42|STANDARD_ERROR_OF_MEAN|1.16|<|0.05|TWO_SIDED|95.0|0.04|4.02|||Regression, Cox||ABT is the numerator and Placebo is the denominator for the hazard ratios. The dispersion value given is the SE of the estimate on the natural log scale.|The null hypothesis for the time to event outcomes is exp(bABT) / exp(bPlacebo) = 1.||4.02|0.04|<0.05
74024068|NCT01440101|147600444|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value obtained from the Van Elteren test stratified by the presence or absence of Gd+ lesions at baseline.|Van Elteren test|||||||<0.001
74024069|NCT01440101|147600445|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon rank sum test|||||||0.006
74024070|NCT01440101|147600446|SUPERIORITY_OR_OTHER||Difference in proportions|0.404|||<|0.001|TWO_SIDED|95.0|0.223|0.586|||Fisher Exact|||Relapse-free proportions compared using a two-sided Fisher exact test. In the analysis, participants with unknown status are considered to have relapsed.||0.586|0.223|<0.001
74024071|NCT01440101|147600447|SUPERIORITY_OR_OTHER|||||||0.729||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline to Week 12||||0.729
74024072|NCT01440101|147600447|SUPERIORITY_OR_OTHER|||||||0.942||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline at Week 24||||0.942
74024073|NCT00636818|147600463|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
73961694|NCT03073941|147459891|NON_INFERIORITY|A non-Inferiority analysis was performed once the 1 year OKS of the first 216 patients were collected. A one-sided T-test, 90% power, SD=10 and with a non-inferiority margin of 4 OKS was used and the analysis was based on the difference of average OKS between Persona and NexGen 1 year postoperatively.|||||<|0.05|||||||t-test, 1 sided|90% power, SD=10 and with a non-inferiority margin of 4 OKS||||||<0.05
73961695|NCT04250883|147459901|SUPERIORITY|||||||0.54|||||||Chi-squared, Corrected|for age||||||0.54
74024074|NCT00636818|147600464|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
74024075|NCT00636818|147600465|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
74024076|NCT00636818|147600466|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.013
74024077|NCT00636818|147600467|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
74024078|NCT00636818|147600468|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
74024079|NCT00636818|147600468|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Color Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
74024080|NCT00636818|147600468|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||P-value for Color-Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.144
74024081|NCT00636818|147600469|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||P-value for Physical Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.791
74024082|NCT00636818|147600469|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
74024083|NCT00636818|147600469|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Physical Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.037
74024084|NCT00636818|147600469|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-value for Role-Physical: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.446
74024085|NCT00636818|147600469|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||P-value for Bodily Pain: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.365
74024086|NCT00636818|147600469|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||P-value for General Health Perception: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.087
74024087|NCT00636818|147600469|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||P-value for Vitality: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.043
74024088|NCT00636818|147600469|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||P-value for Social Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.086
74024089|NCT00636818|147600469|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for Role-Emotional: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.010
74024090|NCT00636818|147600469|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Health: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
74024091|NCT02115308|147600487|SUPERIORITY|||||||0.001|||||||paired, t-test|non-adjusted||REST-TO-REGADENOSON STRESS||||0.001
74024092|NCT02115308|147600487|SUPERIORITY|||||||0.017||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS||||0.017
74024093|NCT02115308|147600487|SUPERIORITY|||||||0.495||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS||||0.495
74024094|NCT02115308|147600487|SUPERIORITY|||||||0.365|||||||t-test, 2 sided|non-adjusted||REST||||0.365
74024095|NCT02115308|147600487|SUPERIORITY|||||||0.602|||||||t-test, 2 sided|non adjusted||REST||||0.602
74024096|NCT02115308|147600487|SUPERIORITY|||||||0.915|||||||t-test, 2 sided|non adjusted||REST||||0.915
74024097|NCT02115308|147600487|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.033
74024098|NCT02115308|147600487|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.002
74024099|NCT02115308|147600487|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.087
74024100|NCT02115308|147600487|SUPERIORITY|||||||0.399|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS CHANGE||||0.399
74024101|NCT02115308|147600487|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change||||0.030
73850477|NCT02720523|147247800|SUPERIORITY||LS Mean Difference|2.66||||0.04|TWO_SIDED|95.0|0.12|5.2|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||5.20|0.12|0.040
73850478|NCT02720523|147247800|SUPERIORITY||LS Mean Difference|1.79||||0.169|TWO_SIDED|95.0|-0.77|4.35|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||4.35|-0.77|0.169
73850479|NCT02720523|147247800|SUPERIORITY||LS Mean Difference|0.85||||0.516|TWO_SIDED|95.0|-1.73|3.43|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||3.43|-1.73|0.516
73850480|NCT02720523|147247801|SUPERIORITY||LS Mean Difference|-2.54||||0.021|TWO_SIDED|95.0|-4.68|-0.39|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-0.39|-4.68|0.021
73850481|NCT02720523|147247801|SUPERIORITY||LS Mean Difference|-2.06||||0.08|TWO_SIDED|95.0|-4.36|0.25|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||0.25|-4.36|0.080
73850482|NCT02720523|147247801|SUPERIORITY||LS Mean Difference|-1.56||||0.22|TWO_SIDED|95.0|-4.06|0.94|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||0.94|-4.06|0.220
73850483|NCT02720523|147247802|SUPERIORITY||LS Mean Difference|-1.81|||<|0.001|TWO_SIDED|95.0|-2.57|-1.04|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.04|-2.57|<0.001
73850484|NCT02720523|147247802|SUPERIORITY||LS Mean Difference|-1.82|||<|0.001|TWO_SIDED|95.0|-2.59|-1.05|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.05|-2.59|<0.001
73850485|NCT02720523|147247802|SUPERIORITY||LS Mean Difference|-1.96|||<|0.001|TWO_SIDED|95.0|-2.73|-1.18|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.18|-2.73|<0.001
73850486|NCT02340169|147247803|OTHER||||||||||||||||||Adrenal suppression rates in the evaluable population were 35% (21 out of 60), 43.3% (13 out of 30) and 20% (2 out of 10) in Cohorts 1, 2 a nd 3, respectively.|||
73850487|NCT03674970|147247806|OTHER|||||||0.55|||||||ANOVA|||||||.55
73850488|NCT03674970|147247807|OTHER|||||||0.2146|||||||ANOVA|||||||.2146
73850489|NCT03674970|147247808|OTHER|||||||0.5642|||||||ANOVA|||||||.5642
73850490|NCT03674970|147247809|OTHER|||||||0.4353|||||||ANOVA|||||||.4353
73850491|NCT03674970|147247810|OTHER|||||||0.0348|||||||ANOVA|||||||.0348
73850492|NCT03674970|147247811|OTHER|||||||0.404|||||||ANOVA|||||||.4040
73961696|NCT04250883|147459902|SUPERIORITY|||||||0.97|||||||Chi-squared, Corrected|for age||||||0.97
73850493|NCT01158820|147247812|OTHER|No data available for power analysis|Mean Difference (Net)|0.028|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73961697|NCT04250883|147459904|SUPERIORITY|||||||0.64||||||At 12 days postoperative|Chi-squared, Corrected|for age||||||0.64
73961698|NCT04250883|147459904|SUPERIORITY|||||||0.38||||||At 3 months postoperative|Chi-squared, Corrected|for age||||||0.38
73961699|NCT04250883|147459905|SUPERIORITY|||||||0.84|||||||Chi-squared, Corrected|For age||Count of patients with or without pain at 3 months postoperative||||0.84
73850494|NCT01158820|147247813|SUPERIORITY||Mean Difference (Final Values)|43.75|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||units are µg|See reference power analysis||||<0.01
73850495|NCT01158820|147247814|SUPERIORITY||Median Difference (Final Values)|1.75||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||units are mg|See reference for power analysis||||0.01
73850496|NCT01740687|147247820|OTHER||95% upper Bayesian credible interval|1.23|||||||||||||%|predetermined study success threshold of 2.1% at 1 year||||
73850497|NCT01740687|147247821|OTHER||95% upper Bayesian credible interval|1.33|||||||||||||%|predetermined study success threshold of 2.8% at 3 years||||
73850498|NCT00326001|147247834|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P-value not adjusted for multiple comparisons|t-test, 2 sided|||||||0.25
73850499|NCT00326001|147247835|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||Chi-squared|||||||0.042
73850500|NCT00326001|147247836|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Chi-squared|||||||0.53
73850501|NCT00326001|147247837|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73850502|NCT01963767|147247841|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||Ancovas were conducted with group as the between subjects factor and performance at baseline as the covariate.||||.03
73850503|NCT03941483|147247844|SUPERIORITY||Risk Ratio (RR)|1.174||||0.595|TWO_SIDED|90.0|0.715|1.927|||Chi-squared|||||1.927|0.715|0.595
73850504|NCT03941483|147247845|SUPERIORITY||Risk Ratio (RR)|1.297||||0.335|TWO_SIDED|90.0|0.831|2.026|||Chi-squared|||||2.026|0.831|0.335
73961700|NCT04250883|147459905|SUPERIORITY|||||||0.89|||||||ANCOVA|Correction for age||Number of Words Chosen||||0.89
73850505|NCT03941483|147247846|SUPERIORITY||Risk Ratio (RR)|1.025||||0.773|TWO_SIDED|90.0|0.891|1.179|||Chi-squared|||||1.179|0.891|0.773
73850506|NCT03941483|147247847|SUPERIORITY||Risk Ratio (RR)|1.038||||0.563|TWO_SIDED|90.0|0.935|1.152|||Chi-squared|||||1.152|0.935|0.563
73850507|NCT03941483|147247848|SUPERIORITY||Risk Ratio (RR)|1.174||||0.717|TWO_SIDED|90.0|0.567|2.429|||Chi-squared|||||2.429|0.567|0.717
73850508|NCT03941483|147247849|SUPERIORITY||Risk Ratio (RR)|1.614||||0.266|TWO_SIDED|90.0|0.789|3.3|||Chi-squared|||||3.300|0.789|0.266
73850509|NCT01082081|147247850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.77||||0.0004|TWO_SIDED|95.0|2.15|7.39|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 500 mg caplet.||7.39|2.15|0.0004
73850510|NCT01082081|147247850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.25|||<|0.0001|TWO_SIDED|95.0|4.04|10.45|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.||10.45|4.04|<0.0001
73961701|NCT04250883|147459905|SUPERIORITY|||||||0.98|||||||ANCOVA|Correction for age||Pain Rating index||||0.98
73850511|NCT01082081|147247850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.48||||0.1307|TWO_SIDED|95.0|-0.74|5.69|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 500 mg caplet and placebo caplet.||5.69|-0.74|0.1307
73850512|NCT00932035|147247865|SUPERIORITY|To achieve a power of 0.84, a sample size of 72 patients, evenly distributed is required. With 36 patients per group, a Fisher's exact test with a one-sided alpha of 0.05 will have a 84% power to detect the difference between the experimental group (axillary reverse mapping) of 5% or less and a control group (standard dissection) of 30% or more. Response estimates were chosen based on reported lymphedema rates.||||||0.45|||||||Fisher Exact|||||||0.45
73850513|NCT00932035|147247866|SUPERIORITY|||||||0.5|||||||Fisher Exact|||||||0.50
73850514|NCT00932035|147247867|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
73850515|NCT02709512|147247900|SUPERIORITY|Relative Risk Ratio (ADIPemPlatinum/PlaceboPemPlatinum) is the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology. A relative risk ratio greater than one is favorable to ADIPemPlatinum.|Risk Ratio (RR)|1.02||||0.9489|TWO_SIDED|95.0|0.5|2.11|||Cochran-Mantel-Haenszel|||||2.11|0.50|0.9489
73850516|NCT02709512|147247901|SUPERIORITY||Cox Proportional Hazard|0.64||||0.0078|TWO_SIDED|95.0|0.47|0.88|||Log Rank|||||0.88|0.47|0.0078
73850517|NCT02709512|147247902|SUPERIORITY||Cox Proportional Hazard|0.71||||0.0234|TWO_SIDED|95.0|0.55|0.93|||Log Rank|||||0.93|0.55|0.0234
73850518|NCT02709512|147247903|SUPERIORITY||Cox Proportional Hazard|0.65||||0.0193|TWO_SIDED|95.0|0.46|0.9|||Log Rank|||||0.90|0.46|0.0193
73961702|NCT04250883|147459906|SUPERIORITY|||||||0.9|||||||ANCOVA|Correction for age||||||0.9
73961703|NCT04250883|147459907|SUPERIORITY|||||||0.68|||||||ANCOVA|Correction for age||At 1 hour||||0.68
73961704|NCT04250883|147459907|SUPERIORITY|||||||0.91|||||||ANCOVA|Correction for age||At 6 hours||||0.91
73961705|NCT04250883|147459907|SUPERIORITY|||||||0.73|||||||ANCOVA|Correction for age||||||0.73
73961706|NCT04250883|147459907|SUPERIORITY|||||||0.77|||||||ANCOVA|Correction for age||||||0.77
73961707|NCT04250883|147459908|SUPERIORITY|||||||0.63|||||||ANCOVA|Correction for age||At 1 hour||||0.63
73961708|NCT04250883|147459908|SUPERIORITY|||||||0.19|||||||ANCOVA|Correction for age||At postoperative day 1||||0.19
73961709|NCT04250883|147459909|SUPERIORITY|||||||0.89|||||||ANCOVA|Correction for age||At 1 hour||||0.89
73961710|NCT04250883|147459909|SUPERIORITY|||||||0.49|||||||ANCOVA|Correction for age||At postoperative day 1||||0.49
73961711|NCT04250883|147459910|SUPERIORITY|||||||0.42|||||||ANCOVA|Correction for age||||||0.42
73961712|NCT04250883|147459911|SUPERIORITY|||||||0.92|||||||ANCOVA|Correction for age||Of Total complications within 30 days postoperative||||0.92
73961713|NCT04250883|147459912|SUPERIORITY|||||||0.098|||||||ANCOVA|correction for age||Time to maximal intensity||||0.098
73961714|NCT04250883|147459912|SUPERIORITY|||||||0.008|||||||ANCOVA|correction for age||Angle from minimal to maximal intensity||||0.008
73961715|NCT04250883|147459912|SUPERIORITY|||||||0.042|||||||ANCOVA|correction for age||Delta between minimal and maximal intensity||||0.042
73961716|NCT04250883|147459913|SUPERIORITY|||||||0.35|||||||ANCOVA|Correction for age||postoperative day 1||||0.35
73961717|NCT04250883|147459913|SUPERIORITY|||||||0.52|||||||ANCOVA|Correction for age||at postoperative day 12||||0.52
73961718|NCT04250883|147459914|SUPERIORITY|||||||0.99|||||||ANCOVA|correction for age||at postoperative day 1||||0.99
73961719|NCT04250883|147459914|SUPERIORITY|||||||0.3|||||||ANCOVA|Correction for age||At postoperative day 12||||0.30
73961720|NCT04250883|147459915|SUPERIORITY|||||||0.42|||||||ANCOVA|Correction for age||||||0.42
73961721|NCT04250883|147459916|SUPERIORITY|||||||0.3|||||||ANCOVA|Correction for age||||||0.3
73961722|NCT04250883|147459917|SUPERIORITY|||||||0.33|||||||ANCOVA|Correction for age||||||0.33
73961723|NCT04250883|147459918|SUPERIORITY|||||||0.018|||||||ANCOVA|Correction for age||||||0.018
73961724|NCT04425629|147459963|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.1|=|0.0006|TWO_SIDED|95.0|-0.52|-0.14|||ANCOVA|||||-0.14|-0.52|= 0.0006
73961725|NCT04425629|147459963|SUPERIORITY||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.56|-0.19|||ANCOVA|||||-0.19|-0.56|< 0.0001
73961726|NCT04425629|147459964|SUPERIORITY||||||=|0.0024|||||||Cochran-Mantel-Haenszel|||||||= 0.0024
73961727|NCT04425629|147459965|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||< 0.0001
73961728|NCT04425629|147459971|SUPERIORITY||||||=|0.1903|||||||Mixed Models Analysis|||||||= 0.1903
73961729|NCT04425629|147459971|SUPERIORITY||||||=|0.8431|||||||Mixed Models Analysis|||||||= 0.8431
73961730|NCT04425629|147460027|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.06|16.12||||||||16.12|0.06|
73961731|NCT04425629|147460028|SUPERIORITY||Hazard Ratio (HR)|0.33|||||TWO_SIDED|95.0|0.03|3.13||||||||3.13|0.03|
73961732|NCT00414544|147460082|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority was tested.|Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.6|||TWO_SIDED|90.0|-2.0|1.0|||Confidence interval|The 90% lower confidence bound of the difference between CosmetaLife and Restylane were computed.|The confidence interval is built around the mean difference of the two reporting groups.|The a priori hypothesis for statistical analysis was based on predetermined clinical relevance being set to a difference score between CosmetaLife and Control (Restylane) of -0.5. This clinical relevance was set to -0.5 because the observation scale used is not accurate below 0.5 differences. That is CosmetaLife needed to be greater than 0.5 less than Control (Restylane) in the treatment difference scores to be considered inferior.||1.0|-2.0|
73961733|NCT01149369|147460087|NON_INFERIORITY_OR_EQUIVALENCE|P-values, relative risk ratios, and 95% confidence limits (CI) for the primary ITT were calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by clinic.|Risk Ratio (RR)|1.2||||0.43|TWO_SIDED|95.0|0.8|1.7|||Cochran-Mantel-Haenszel|Stratified by clinic||Either 1) improvement in mean of available nausea VAS scores over 28-day treatment period compared to means of VAS during the 7-day baseline (BL) period being ≤ -25 mm, or 2) mean VAS after 28-days of treatment was \< 25 mm.||1.7|0.8|0.43
73961734|NCT01149369|147460088|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.5||||0.03|TWO_SIDED|95.0|-2.8|-0.1|||ANCOVA|||||-0.1|-2.8|0.03
73961735|NCT01149369|147460089|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.94|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.94
73961736|NCT01149369|147460090|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.73|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.73
73961737|NCT01149369|147460091|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.22
73961738|NCT01149369|147460092|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.06|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0.0|-0.6|0.06
73961739|NCT01149369|147460093|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.24|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.24
74024102|NCT02115308|147600487|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change||||0.048
74024103|NCT02115308|147600488|SUPERIORITY|||||||0.011||||||Non-adjusted.|paired, t-test|||Rest VS Regadenoson Stress||||0.011
74024104|NCT02115308|147600488|SUPERIORITY|||||||0.003||||||non-adjusted|paired t-test|||Rest VS Regadenoson Stress||||0.003
74024105|NCT02115308|147600488|SUPERIORITY|non-adjusted||||||0.39|||||||paired, t-test|||Rest VS Regadenoson Stress||||0.390
74024106|NCT02115308|147600488|SUPERIORITY|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST||||<0.000
74024107|NCT02115308|147600488|SUPERIORITY|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST||||<0.000
74024108|NCT02115308|147600488|SUPERIORITY|non-adjusted||||||0.022|||||||t-test, 2 sided|||REST||||0.022
74024109|NCT02115308|147600488|SUPERIORITY|||||||0.001||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||0.001
74024110|NCT02115308|147600488|SUPERIORITY||||||<|0||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||<0.000
74024111|NCT02115308|147600488|SUPERIORITY|||||||0.006||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||0.006
74024112|NCT02115308|147600488|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change||||<0.000
74024113|NCT02115308|147600488|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Changes||||0.058
73850519|NCT01734785|147247926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-0.93|-0.46|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) \& baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-0.46|-0.93|<0.0001
73850520|NCT01734785|147247926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.02|-0.55|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) \& baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-0.55|-1.02|<0.0001
73850521|NCT01734785|147247927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001||95.0|-2.61|-1.57|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.57|-2.61|<0.0001
73850522|NCT01734785|147247927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001||95.0|-2.31|-1.28|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.28|-2.31|<0.0001
73850523|NCT01734785|147247928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|-2.92|-1.52|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.52|-2.92|<0.0001
73850524|NCT01734785|147247928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|-3.47|-2.07|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo:change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-2.07|-3.47|<0.0001
73961740|NCT01149369|147460094|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.01|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.01
74024114|NCT02115308|147600488|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change||||0.310
74024115|NCT02115308|147600489|SUPERIORITY|||||||0.001|||||||paired, t-test|non adjusted||REST vs STRESS||||0.001
74024116|NCT02115308|147600489|SUPERIORITY|||||||0.002|||||||paired, t-test|non adjusted||REST vs STRESS||||0.002
74024117|NCT02115308|147600489|SUPERIORITY|||||||0.721|||||||paired, t-test|non adjusted||REST vs STRESS||||0.721
74024118|NCT02115308|147600489|SUPERIORITY|||||||0.797|||||||t-test, 2 sided|non adjusted||REST||||0.797
74024119|NCT02115308|147600489|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|non adjusted||REST||||0.474
74024120|NCT02115308|147600489|SUPERIORITY|||||||0.537|||||||t-test, 2 sided|non adjusted||||||0.537
74024121|NCT02115308|147600489|SUPERIORITY|||||||0.717|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.717
74024122|NCT02115308|147600489|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.041
74024123|NCT02115308|147600489|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.050
74024124|NCT02115308|147600489|SUPERIORITY|||||||0.908||||||non adjusted|t-test, 2 sided|||REST-to-STRESS Change||||0.908
74024125|NCT02115308|147600489|SUPERIORITY|||||||0.233|||||||t-test, 2 sided|non adjusted||||||0.233
74024126|NCT02115308|147600489|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.187
74024127|NCT02115308|147600491|SUPERIORITY|||||||0.008|||||||paired, t-test|non adjusted||REST vs STRESS||||0.008
74024128|NCT02115308|147600491|SUPERIORITY|||||||0.006|||||||paired, t-test|non adjusted||REST vs STRESS||||0.006
74024129|NCT02115308|147600491|SUPERIORITY|||||||0.428|||||||paired, t-test|non adjusted||REST vs STRESS||||0.428
74024130|NCT02115308|147600491|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST||||<0.000
74088259|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.2||0.0246|TWO_SIDED|95.0|-0.82|-0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.82|0.0246
73850525|NCT02476032|147247937|OTHER|||||||0.05|TWO_SIDED|90.0||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.||||0.05
73850526|NCT02476032|147247938|OTHER|||||||0.05|TWO_SIDED|90.0||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.||||0.05
73850527|NCT00293813|147247947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||||95.0|2.6|5.7|||ANCOVA|||||5.7|2.6|
73850528|NCT00293813|147247947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||||95.0|-0.6|2.6|||ANCOVA|||||2.6|-.6|
73850529|NCT00473889|147247956|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Log Rank|Disease stage and bevacizumab eligibility are the stratification factors in the stratified log rank test.||||||0.992
73850530|NCT00473889|147247957|SUPERIORITY_OR_OTHER|||||||0.862||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Finkelstein's Interval Censored Method|Disease stage and bevacizumab eligibility are the stratification factors in the Finkelstein's Interval Censored Method Model.||||||0.862
73850531|NCT00473889|147247958|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Miettinen and Nurminen|Disease stage and bevacizumab eligibility are the stratification factors in the stratified Miettinen and Nurmimen method.||||||0.899
73850532|NCT04830215|147247967|OTHER||||||<|0.0001||||||MMRM included fixed effect terms for visit, baseline value, an interaction term of baseline value by visit, and trial center.|MMRM|||||||<0.0001
73850533|NCT04830215|147247968|OTHER||||||<|0.0001||||||MMRM included fixed effect terms for visit, baseline value, an interaction term of baseline value by visit, and trial center.|MMRM|||||||<0.0001
73850534|NCT00635349|147247987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower confidence limit interval was less than -1.0 (1-sided , 97.5% confidence interval)|Mean Difference (Final Values)|1.81||||0.4258|ONE_SIDED|97.5|-6.31||||t-test, 1 sided||||||-6.31|0.4258
74024131|NCT02115308|147600491|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST||||<0.000
74024132|NCT02115308|147600491|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|non adjusted||REST||||0.006
73850535|NCT00635349|147247988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0628|ONE_SIDED|97.5|-1.41||||t-test, 1 sided||||||-1.41|0.0628
73850536|NCT00635349|147247989|SUPERIORITY_OR_OTHER|||||||0.0131||||||Day 29: p-value was calculated by fisher exact test|Fisher Exact|||||||0.0131
73850537|NCT00635349|147247989|SUPERIORITY_OR_OTHER|||||||0.9834||||||Day 57; p-value was calculated by Chi-squared test|Chi-squared|||||||0.9834
73850538|NCT00635349|147247989|SUPERIORITY_OR_OTHER|||||||0.1131||||||Day 85; p-value was calculated by Chi-squared test|Chi-squared|||||||0.1131
73850539|NCT01340664|147248008|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.637|-0.251|||ANCOVA|||||-0.251|-0.637|<0.001
73850540|NCT01340664|147248008|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.792|-0.407|||ANCOVA|||||-0.407|-0.792|<0.001
73850541|NCT01340664|147248009|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-23.6|STANDARD_ERROR_OF_MEAN|4.673|<|0.001|TWO_SIDED|95.0|-32.78|-14.38|||ANCOVA|||||-14.38|-32.78|<0.001
73850542|NCT01340664|147248009|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-24.0|STANDARD_ERROR_OF_MEAN|4.661|<|0.001||95.0|-33.18|-14.83|||ANCOVA|||||-14.83|-33.18|<0.001
74024133|NCT02115308|147600491|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.002
73850543|NCT01340664|147248010|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.1|-1.3|||ANCOVA|||||-1.3|-3.1|<0.001
74024134|NCT02115308|147600491|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||<0.000
74024135|NCT02115308|147600491|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.004
74024136|NCT02115308|147600491|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||<0.000
74024137|NCT02115308|147600491|SUPERIORITY|||||||0.172|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.172
74024138|NCT02115308|147600491|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.957
74024139|NCT01658514|147600512|SUPERIORITY_OR_OTHER||% Ratio of LS Means|51.5||||0.0011|TWO_SIDED|90.0|37.77|70.23||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||70.23|37.77|0.0011
73850544|NCT01340664|147248010|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.5|-1.7|||ANCOVA|||||-1.7|-3.5|<0.001
73850545|NCT01340664|147248011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.013|TWO_SIDED|95.0|1.21|4.9|||Regression, Logistic|||||4.90|1.21|0.013
73850546|NCT01340664|147248011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.38|||<|0.001|TWO_SIDED|95.0|1.68|6.81|||Regression, Logistic|||||6.81|1.68|<0.001
73850547|NCT03994211|147248015|OTHER||Geometric Mean Ratio Estimate|0.94|||||TWO_SIDED|90.0|0.83|1.06||||||||1.06|0.83|
73850548|NCT03994211|147248016|OTHER||Geometric Mean Ratio|1.05|||||TWO_SIDED|90.0|0.95|1.15||||||||1.15|0.95|
73850549|NCT03994211|147248017|OTHER||Geometric Mean Ratio|0.62|||||TWO_SIDED|90.0|0.54|0.7||||||||0.70|0.54|
73850550|NCT03994211|147248018|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.91|1.09||||||||1.09|0.91|
73850551|NCT03994211|147248019|OTHER||Geometric Mean Ratio|0.57|||||TWO_SIDED|90.0|0.48|0.69||||||||0.69|0.48|
73850552|NCT03994211|147248020|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.9|1.09||||||||1.09|0.90|
73850553|NCT01926444|147248049|OTHER|||||||0.506|||||||ANOVA|||AUC- censorsed (standardized); FAS||||0.506
73850554|NCT01926444|147248049|OTHER|||||||0.299|||||||ANOVA|||AUC LOCF (standardized); FAS||||0.299
73961741|NCT01149369|147460095|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.22
73961742|NCT01149369|147460096|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.03||||0.51|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.51
73961743|NCT01149369|147460097|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.12|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.12
73850555|NCT01926444|147248049|OTHER|||||||0.234|||||||ANOVA|||AUC Censored (Standardized)- PP Population||||0.234
73961744|NCT01149369|147460098|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|0.02
73961745|NCT01149369|147460099|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.17|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||||0.7|-0.1|0.17
73850556|NCT01926444|147248049|OTHER|||||||0.219|||||||ANOVA|||AUC LOCF (Standardized)- PP Population||||0.219
73850557|NCT01926444|147248050|OTHER|||||||0.047|||||||Chi-squared|||Time to Caecum||||0.047
73850558|NCT01926444|147248051|OTHER|||||||0.047|||||||Chi-squared|||||||0.047
73850559|NCT03579693|147248058|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.33|TWO_SIDED|95.0|-0.43|1.31|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||1.31|-0.43|0.33
73850560|NCT03579693|147248058|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.93|TWO_SIDED|95.0|-0.9|0.82|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||0.82|-0.90|0.93
73850561|NCT03579693|147248059|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.05|TWO_SIDED|95.0|-3.47|0.0|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||0.00|-3.47|0.050
73850562|NCT03579693|147248059|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.47|TWO_SIDED|95.0|-2.28|1.05|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||1.05|-2.28|0.47
73850563|NCT01637584|147248099|SUPERIORITY_OR_OTHER||||||<|0.001||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \> Non-Rapid Eye Movement (NREM): Mean K-cluster voxels (Ke)=15,586: x,y,z= -36, -74, 0. Left Brodmann's Area (BA) 3, 6, 7, 10, 17, 19, 20,21,23, 38||||<0.001
73850564|NCT01637584|147248099|SUPERIORITY_OR_OTHER|||||||0.039||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \< NREM: Ke=7,013: x,y,z= 26, 22, -40. Right BA 4, 10-14, 21, 25, 32, 38, 45;||||0.039
73850565|NCT01637584|147248099|SUPERIORITY_OR_OTHER|||||||0.701||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \> (Rapid Eye Movement (REM): No cluster size, coordinates, or brain regions to report||||0.701
73850566|NCT01637584|147248099|SUPERIORITY_OR_OTHER|||||||1||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \< REM: No cluster size, coordinates, or brain regions to report||||1.00
73850567|NCT01637584|147248099|SUPERIORITY_OR_OTHER|||||||0.03||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Within-state decrease in rCMRglc: Ke=6,150: x,y,z= -30, -30, 2. Left BA 40, insula, hippocampus, caudate, and putamen;||||0.03
73850568|NCT01637584|147248099|SUPERIORITY_OR_OTHER|||||||0.01||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Within-state increase in rCMRglc: Ke=7,049: x,y,z= 66, -18, 26. Right BA 1, 3, 15, 21, 22, 23, 41, 42||||0.01
73850569|NCT02969915|147248103|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.64|2.26||||||||2.26|0.64|
73850570|NCT02969915|147248104|SUPERIORITY||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.91|1.9||||||||1.90|0.91|
73850571|NCT02969915|147248105|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.7|1.95||||||||1.95|0.70|
73850572|NCT02969915|147248106|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.85|1.95||||||||1.95|0.85|
73850573|NCT02969915|147248107|SUPERIORITY||Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|0.79|1.75||||||||1.75|0.79|
73850574|NCT02969915|147248108|SUPERIORITY||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|0.38|5.76||||||||5.76|0.38|
73850575|NCT02969915|147248109|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.68|1.36||||||||1.36|0.68|
73850576|NCT02969915|147248110|SUPERIORITY||Risk Ratio, log|1.38|||||TWO_SIDED|95.0|0.77|2.46||||||||2.46|0.77|
73850577|NCT02969915|147248111|SUPERIORITY||Risk Ratio (RR)|0.39|||||TWO_SIDED|95.0|0.09|1.8||||||||1.80|0.09|
73850578|NCT02622295|147248123|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73850579|NCT02622295|147248124|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73850580|NCT02622295|147248125|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73850581|NCT02622295|147248126|SUPERIORITY|||||||0.467|||||||ANOVA|||||||0.467
73850582|NCT02622295|147248127|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73850583|NCT02622295|147248128|SUPERIORITY|||||||0.932|||||||ANOVA|||||||0.932
73850584|NCT02622295|147248129|SUPERIORITY|||||||0.326|||||||ANOVA|||||||0.326
73850585|NCT02622295|147248130|SUPERIORITY|||||||0.673|||||||ANOVA|||||||0.673
73850586|NCT02622295|147248131|SUPERIORITY|||||||0.539|||||||ANOVA|||||||0.539
73850587|NCT02622295|147248132|SUPERIORITY|||||||0.155|||||||ANOVA|||||||0.155
73850588|NCT02622295|147248133|SUPERIORITY|||||||0.164|||||||ANOVA|||||||0.164
73850589|NCT02622295|147248134|SUPERIORITY|||||||0.493|||||||ANOVA|||||||0.493
73850590|NCT02622295|147248135|SUPERIORITY|||||||0.458|||||||ANOVA|||||||0.458
73850591|NCT01393899|147248136|SUPERIORITY_OR_OTHER||Difference in Percentage|1.44|||||TWO_SIDED|80.0|-12.11|14.99||||||||14.99|-12.11|
73850592|NCT01393899|147248136|SUPERIORITY_OR_OTHER||Difference in Percentage|17.72|||||TWO_SIDED|80.0|4.07|31.37||||||||31.37|4.07|
73850593|NCT01393899|147248137|SUPERIORITY_OR_OTHER||Difference in Percentage|0.61|||||TWO_SIDED|80.0|-11.57|12.79||||||Week 4||12.79|-11.57|
73850594|NCT01393899|147248137|SUPERIORITY_OR_OTHER||Difference in Percentage|0.78|||||TWO_SIDED|80.0|-12.29|13.84||||||Week 8||13.84|-12.29|
73850595|NCT01393899|147248137|SUPERIORITY_OR_OTHER||Difference in Percentage|5.81|||||TWO_SIDED|80.0|-8.04|19.67||||||Week 12||19.67|-8.04|
73850596|NCT01393899|147248137|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.94|||||TWO_SIDED|80.0|-14.56|12.68||||||Week 20||12.68|-14.56|
73850597|NCT01393899|147248137|SUPERIORITY_OR_OTHER||Difference in Percentage|5.26|||||TWO_SIDED|80.0|-6.52|17.04||||||Week 4||17.04|-6.52|
73850598|NCT01393899|147248137|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.53|||||TWO_SIDED|80.0|-21.94|4.88||||||Week 8||4.88|-21.94|
73850599|NCT01393899|147248137|SUPERIORITY_OR_OTHER||Difference in Percentage|3.49|||||TWO_SIDED|80.0|-10.4|17.37||||||Week 12||17.37|-10.40|
73850600|NCT01393899|147248137|SUPERIORITY_OR_OTHER||Difference in Percentage|10.69|||||TWO_SIDED|80.0|-3.08|24.46||||||Week 20||24.46|-3.08|
73850601|NCT01393899|147248138|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.72|||||TWO_SIDED|80.0|-14.06|10.63||||||Week 4||10.63|-14.06|
73850602|NCT01393899|147248138|SUPERIORITY_OR_OTHER||Difference in Percentage|-3.88|||||TWO_SIDED|80.0|-17.15|9.4||||||Week 8||9.40|-17.15|
73850603|NCT01393899|147248138|SUPERIORITY_OR_OTHER||Difference in Percentage|5.81|||||TWO_SIDED|80.0|-8.04|19.67||||||Week 12||19.67|-8.04|
73850604|NCT01393899|147248138|SUPERIORITY_OR_OTHER||Difference in Percentage|1.44|||||TWO_SIDED|80.0|-12.11|14.99||||||Week 20||14.99|-12.11|
73850605|NCT01393899|147248138|SUPERIORITY_OR_OTHER||Difference in Percentage|1.5|||||TWO_SIDED|80.0|-11.88|14.87||||||Week 26||14.87|-11.88|
73850606|NCT01393899|147248138|SUPERIORITY_OR_OTHER||Difference in Percentage|2.93|||||TWO_SIDED|80.0|-9.06|14.92||||||Week 4||14.92|-9.06|
73850607|NCT01393899|147248138|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.53|||||TWO_SIDED|80.0|-21.94|4.88||||||Week 8||4.88|-21.94|
73850608|NCT01393899|147248138|SUPERIORITY_OR_OTHER||Difference in Percentage|1.16|||||TWO_SIDED|80.0|-12.74|15.06||||||Week 12||15.06|-12.74|
73850609|NCT01393899|147248138|SUPERIORITY_OR_OTHER||Difference in Percentage|13.07|||||TWO_SIDED|80.0|-0.63|26.77||||||Week 20||26.77|-0.63|
73850610|NCT01393899|147248138|SUPERIORITY_OR_OTHER||Difference in Percentage|20.1|||||TWO_SIDED|80.0|6.54|33.66||||||Week 26||33.66|6.54|
73850611|NCT01393899|147248139|SUPERIORITY_OR_OTHER||Difference in Percentage|3.43|||||TWO_SIDED|80.0|-10.41|17.28||||||Week 4||17.28|-10.41|
73850612|NCT01393899|147248139|SUPERIORITY_OR_OTHER||Difference in Percentage|1.22|||||TWO_SIDED|80.0|-12.67|15.11||||||Week 8||15.11|-12.67|
73850613|NCT01393899|147248139|SUPERIORITY_OR_OTHER||Difference in Percentage|13.18|||||TWO_SIDED|80.0|-0.31|26.67||||||Week 12||26.67|-0.31|
73850614|NCT01393899|147248139|SUPERIORITY_OR_OTHER||Difference in Percentage|1.61|||||TWO_SIDED|80.0|-11.33|14.55||||||Week 20||14.55|-11.33|
73850615|NCT01393899|147248139|SUPERIORITY_OR_OTHER||Difference in Percentage|8.64|||||TWO_SIDED|80.0|-4.36|21.64||||||Week 26||21.64|-4.36|
73850616|NCT01393899|147248139|SUPERIORITY_OR_OTHER||Difference in Percentage|5.76|||||TWO_SIDED|80.0|-8.04|19.56||||||Week 4||19.56|-8.04|
73850617|NCT01393899|147248139|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.08|||||TWO_SIDED|80.0|-21.83|5.66||||||Week 8||5.66|-21.83|
73850618|NCT01393899|147248139|SUPERIORITY_OR_OTHER||Difference in Percentage|1.55|||||TWO_SIDED|80.0|-11.63|14.73||||||Week 12||14.73|-11.63|
73850619|NCT01393899|147248139|SUPERIORITY_OR_OTHER||Difference in Percentage|8.58|||||TWO_SIDED|80.0|-4.64|21.81||||||Week 20||21.81|-4.64|
73850620|NCT01393899|147248139|SUPERIORITY_OR_OTHER||Difference in Percentage|13.29|||||TWO_SIDED|80.0|0.15|26.43||||||Week 26||26.43|0.15|
73850621|NCT01393899|147248140|SUPERIORITY_OR_OTHER||Difference in Percentage|6.57|||||TWO_SIDED|80.0|-8.63|21.78||||||Week 4||21.78|-8.63|
73850622|NCT01393899|147248140|SUPERIORITY_OR_OTHER||Difference in Percentage|0.29|||||TWO_SIDED|80.0|-16.63|17.2||||||Week 8||17.20|-16.63|
73850623|NCT01393899|147248140|SUPERIORITY_OR_OTHER||Difference in Percentage|24.29|||||TWO_SIDED|80.0|7.19|41.38||||||Week 12||41.38|7.19|
73850624|NCT01393899|147248140|SUPERIORITY_OR_OTHER||Difference in Percentage|6.86|||||TWO_SIDED|80.0|-10.32|24.03||||||Week 20||24.03|-10.32|
73850625|NCT01393899|147248140|SUPERIORITY_OR_OTHER||Difference in Percentage|11.29|||||TWO_SIDED|80.0|-5.22|27.79||||||Week 26||27.79|-5.22|
73850626|NCT01393899|147248140|SUPERIORITY_OR_OTHER||Difference in Percentage|8.77|||||TWO_SIDED|80.0|-6.41|23.95||||||Week 4||23.95|-6.41|
73850627|NCT01393899|147248140|SUPERIORITY_OR_OTHER||Difference in Percentage|-14.0|||||TWO_SIDED|80.0|-31.59|3.59||||||Week 8||3.59|-31.59|
73850628|NCT01393899|147248140|SUPERIORITY_OR_OTHER||Difference in Percentage|2.31|||||TWO_SIDED|80.0|-15.35|19.97||||||Week 12||19.97|-15.35|
73850629|NCT01393899|147248140|SUPERIORITY_OR_OTHER||Difference in Percentage|10.15|||||TWO_SIDED|80.0|-7.41|27.71||||||Week 20||27.71|-7.41|
73850630|NCT01393899|147248140|SUPERIORITY_OR_OTHER||Difference in Percentage|22.0|||||TWO_SIDED|80.0|4.96|39.04||||||Week 26||39.04|4.96|
73850631|NCT01393899|147248141|SUPERIORITY_OR_OTHER||Difference in Percentage|1.83|||||TWO_SIDED|80.0|-9.75|13.4||||||||13.40|-9.75|
73850632|NCT01393899|147248141|SUPERIORITY_OR_OTHER||Difference in Percentage|18.11|||||TWO_SIDED|80.0|5.57|30.64||||||||30.64|5.57|
73850633|NCT01393899|147248142|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.75|||||TWO_SIDED|80.0|-20.39|4.88||||||||4.88|-20.39|
73850634|NCT01393899|147248142|SUPERIORITY_OR_OTHER||Difference in Percentage|17.83|||||TWO_SIDED|80.0|4.33|31.33||||||||31.33|4.33|
73850635|NCT01393899|147248144|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.26|||=|0.0637|TWO_SIDED|80.0|-51.1|-9.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-9.42|-51.10|=0.0637
73961746|NCT01149369|147460100|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.6||||0.59|TWO_SIDED|95.0|-7.0|12.2|||ANCOVA|||||12.2|-7.0|0.59
73850636|NCT01393899|147248144|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.06|||=|0.3054|TWO_SIDED|80.0|-47.43|5.31|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||5.31|-47.43|=0.3054
73961747|NCT01149369|147460101|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.1||||0.61|TWO_SIDED|95.0|-5.9|10.0|||ANCOVA|||||10.0|-5.9|0.61
73961748|NCT01149369|147460102|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.23|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|||||0.2|-0.1|0.23
73961749|NCT01149369|147460103|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.97|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||||0.5|-0.5|0.97
73961750|NCT01149369|147460104|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|3.1||||0.77|TWO_SIDED|95.0|-18.0|24.2|||ANCOVA|||||24.2|-18.0|0.77
73961751|NCT01149369|147460105|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.46|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.46
73961752|NCT01149369|147460106|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.44|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||||0.4|-0.2|0.44
74024140|NCT01658514|147600512|SUPERIORITY_OR_OTHER||% Ratio of LS Means|73.8||||0.0733|TWO_SIDED|90.0|55.97|97.43||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||97.43|55.97|0.0733
73850637|NCT01393899|147248144|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.52|||=|0.1316|TWO_SIDED|80.0|-78.57|-6.48|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-6.48|-78.57|=0.1316
73850638|NCT01393899|147248144|SUPERIORITY_OR_OTHER||Adjusted Mean Dofference|-18.01|||=|0.5704|TWO_SIDED|80.0|-59.01|22.99|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||22.99|-59.01|=0.5704
73850639|NCT01393899|147248144|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.0|||=|0.8389|TWO_SIDED|80.0|-44.22|32.21|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||32.21|-44.22|=0.8389
73850640|NCT01393899|147248144|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.56|||=|0.1452|TWO_SIDED|80.0|-44.27|-2.85|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-2.85|-44.27|=0.1452
73850641|NCT01393899|147248144|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.61|||=|0.6399|TWO_SIDED|80.0|-36.03|16.81|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||16.81|-36.03|=0.6399
73850642|NCT01393899|147248144|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.0|||=|0.1949|TWO_SIDED|80.0|-73.57|-0.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.42|-73.57|=0.1949
73961753|NCT01149369|147460107|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.77|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||||0.9|-0.7|0.77
73961754|NCT01149369|147460108|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.8|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.80
73961755|NCT01149369|147460109|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.88|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.88
73961756|NCT01149369|147460110|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-10.9||||0.17|TWO_SIDED|95.0|-26.5|4.7|||ANCOVA|||||4.7|-26.5|0.17
73961757|NCT01149369|147460111|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.07|TWO_SIDED|95.0|-1.5|0.0|||ANCOVA|||||0.0|-1.5|0.07
73961758|NCT01149369|147460112|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.53|TWO_SIDED|95.0|-0.7|1.3|||ANCOVA|||||1.3|-0.7|0.53
73961759|NCT01149369|147460113|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.93|TWO_SIDED|95.0|-0.9|1.0|||ANCOVA|||||1.0|-0.9|0.93
73961760|NCT01149369|147460114|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.52|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||||0.2|-1.0|0.52
73961761|NCT01149369|147460115|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.76|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.76
73961762|NCT01149369|147460116|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.45|TWO_SIDED|95.0|-2.0|0.9|||ANCOVA|||||0.9|-2.0|0.45
73961763|NCT01149369|147460117|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.18|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||||0.1|0.0|0.18
73961764|NCT01149369|147460118|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.008|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|||||-0|-0.2|0.008
73961765|NCT01149369|147460119|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||||-0.3|-0.9|0.001
73961766|NCT01149369|147460120|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|<0.001
73961767|NCT01149369|147460121|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.13|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.13
74024141|NCT01658514|147600512|SUPERIORITY_OR_OTHER||% Ratio of LS Means|56.7||||0.0028|TWO_SIDED|90.0|42.25|76.1||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||76.10|42.25|0.0028
73961768|NCT01149369|147460122|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.004|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||||-0.2|-1.2|0.004
73961769|NCT01149369|147460123|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.08
73961770|NCT01149369|147460124|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.007|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.007
73961771|NCT01149369|147460125|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.005|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||||-0.2|-1.3|0.005
73961772|NCT01149369|147460126|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.001|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||||-0.3|-1.1|0.001
74024142|NCT01658514|147600512|SUPERIORITY_OR_OTHER||% Ratio of LS Means|52.4||||0.0025|TWO_SIDED|90.0|37.61|73.02||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||73.02|37.61|0.0025
74024143|NCT01658514|147600513|SUPERIORITY_OR_OTHER||% Ratio of LS Means|65.5||||0.0474|TWO_SIDED|90.0|46.32|92.68||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||92.68|46.32|0.0474
74024144|NCT01658514|147600513|SUPERIORITY_OR_OTHER||% Ratio of LS Means|77.3||||0.1691|TWO_SIDED|90.0|56.72|105.41||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||105.41|56.72|0.1691
74024145|NCT01658514|147600513|SUPERIORITY_OR_OTHER||% Ratio of LS Means|56.6||||0.0064|TWO_SIDED|90.0|40.73|78.63||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||78.63|40.73|0.0064
74024146|NCT01658514|147600513|SUPERIORITY_OR_OTHER||% Ratio of LS Means|54.6||||0.0097|TWO_SIDED|90.0|37.68|79.11||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||79.11|37.68|0.0097
73850643|NCT01393899|147248144|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.74|||=|0.1358|TWO_SIDED|80.0|-88.62|-6.87|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||-6.87|-88.62|=0.1358
73850644|NCT01393899|147248144|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-50.38|||=|0.089|TWO_SIDED|80.0|-88.03|-12.72|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-12.72|-88.03|=0.0890
73850645|NCT01393899|147248145|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.44|||||TWO_SIDED|80.0|-16.14|1.26||||||Week 4||1.26|-16.14|
73850646|NCT01393899|147248145|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.43|||||TWO_SIDED|80.0|-18.27|3.41||||||Week 8||3.41|-18.27|
73850647|NCT01393899|147248145|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.48|||||TWO_SIDED|80.0|-25.68|0.72||||||Week 12||0.72|-25.68|
73850648|NCT01393899|147248145|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.73|||||TWO_SIDED|80.0|-26.81|1.34||||||Week 20||1.34|-26.81|
73850649|NCT01393899|147248145|SUPERIORITY_OR_OTHER||Difference in Percentage|-18.9|||||TWO_SIDED|80.0|-39.52|1.72||||||Week 26||1.72|-39.52|
73850650|NCT01393899|147248145|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.96|||||TWO_SIDED|80.0|-12.39|6.48||||||Week 4||6.48|-12.39|
73850651|NCT01393899|147248145|SUPERIORITY_OR_OTHER||Difference in Percentage|1.61|||||TWO_SIDED|80.0|-10.14|13.36||||||Week 8||13.36|-10.14|
73850652|NCT01393899|147248145|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.09|||||TWO_SIDED|80.0|-21.54|5.36||||||Week 12||5.36|-21.54|
73850653|NCT01393899|147248145|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.9|||||TWO_SIDED|80.0|-26.99|1.19||||||Week 20||1.19|-26.99|
73850654|NCT01393899|147248145|SUPERIORITY_OR_OTHER||Difference in Percentage|-26.28|||||TWO_SIDED|80.0|-46.54|-6.02||||||Week 26||-6.02|-46.54|
73850655|NCT01393899|147248146|SUPERIORITY_OR_OTHER||Difference in Percentage|10.61|||||TWO_SIDED|80.0|-11.44|32.66||||||||32.66|-11.44|
73850656|NCT01393899|147248146|SUPERIORITY_OR_OTHER||Difference in Percentage|16.67|||||TWO_SIDED|80.0|-4.15|37.49||||||||37.49|-4.15|
73850657|NCT01393899|147248148|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.53|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-0.53|-1.34|<0.0001
73850658|NCT01393899|147248148|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.76|||=|0.0024|TWO_SIDED|95.0|-1.24|-0.28|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.28|-1.24|=0.0024
73850659|NCT01393899|147248148|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.75|||=|0.0044|TWO_SIDED|95.0|-1.26|-0.24|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.24|-1.26|=0.0044
73850660|NCT01393899|147248148|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||=|0.0582|TWO_SIDED|95.0|-1.13|0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||0.02|-1.13|=0.0582
73850661|NCT01393899|147248148|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.61|||=|0.0865|TWO_SIDED|95.0|-1.31|0.09|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||0.09|-1.31|=0.0865
73850662|NCT01393899|147248148|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.52|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-0.52|-1.32|<0.0001
73850663|NCT01393899|147248148|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.92|||=|0.0002|TWO_SIDED|95.0|-1.4|-0.45|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.45|-1.40|=0.0002
73850664|NCT01393899|147248148|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.75|-0.71|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.71|-1.75|<0.0001
73850665|NCT01393899|147248148|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.87|-0.74|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||-0.74|-1.87|<0.0001
73850666|NCT01393899|147248148|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.62|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.95|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.95|-2.30|<0.0001
73850667|NCT01393899|147248150|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.39|||=|0.0566|TWO_SIDED|95.0|-0.79|0.01|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||0.01|-0.79|=0.0566
73850668|NCT01393899|147248150|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|||=|0.3144|TWO_SIDED|95.0|-0.61|0.2|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||0.20|-0.61|=0.3144
73961773|NCT01149369|147460127|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.003|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|||||-0.3|-2.3|0.003
73961774|NCT01149369|147460128|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.03|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||||-0.1|-1.0|0.03
73961775|NCT01149369|147460129|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.16|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.16
73961776|NCT01149369|147460130|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.05
73850669|NCT01393899|147248150|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||=|0.0434|TWO_SIDED|95.0|-1.1|-0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.02|-1.10|=0.0434
73850670|NCT01393899|147248150|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.57|||=|0.005|TWO_SIDED|95.0|-0.96|-0.18|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.18|-0.96|=0.0050
73850671|NCT01393899|147248150|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.66|||=|0.0017|TWO_SIDED|95.0|-1.06|-0.25|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.25|-1.06|=0.0017
73850672|NCT01393899|147248150|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.72|-0.67|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.67|-1.72|<0.0001
73850673|NCT00995436|147248161|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.53|0.36|||||Maxillary right molar|||0.36|-1.53|
73850674|NCT00995436|147248161|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.89|-0.04|||||Maxillary left molar|||-0.04|-1.89|
73850675|NCT00995436|147248161|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|0.62|||||TWO_SIDED|95.0|-0.32|1.55|||||Maxillary right molar|||1.55|-0.32|
73850676|NCT00995436|147248161|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-1.0|0.83|||||Maxillary left molar|||0.83|-1|
73850677|NCT00995436|147248161|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.05||||||Maxillary right molar. F(2, 67) = 3.10. Overall effect of treatment.|ANCOVA|||||||0.05
73850678|NCT00995436|147248161|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.08||||||Overall effect of treatment F(2,67) = 2.58.|ANCOVA|||Maxillary left molar.||||0.08
73850679|NCT02131662|147248163|SUPERIORITY_OR_OTHER||Percentage difference|58.28|||||TWO_SIDED|95.0|44.55|70.94||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||70.94|44.55|
73850680|NCT02131662|147248163|SUPERIORITY_OR_OTHER||Percentage difference|52.37|||||TWO_SIDED|95.0|38.8|65.42||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||65.42|38.8|
73850681|NCT02131662|147248163|SUPERIORITY_OR_OTHER||Percentage difference|54.01|||||TWO_SIDED|95.0|40.41|66.95||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||66.95|40.41|
73850682|NCT02131662|147248163|SUPERIORITY_OR_OTHER||Percentage difference|28.28|||||TWO_SIDED|95.0|15.92|41.5||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||41.5|15.92|
73850683|NCT00809926|147248178|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.6||||0.295|TWO_SIDED|95.0|-4.61|1.4|||ANCOVA|||||1.40|-4.61|0.295
73850684|NCT00809926|147248179|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.2||||0.79|TWO_SIDED|95.0|-1.93|1.47|||ANCOVA|||||1.47|-1.93|0.790
73850685|NCT00809926|147248180|SUPERIORITY_OR_OTHER||Difference|8.1||||0.101|TWO_SIDED|95.0|-1.56|17.67|||Cochran-Mantel-Haenszel|||||17.67|-1.56|0.101
73850686|NCT00809926|147248181|SUPERIORITY_OR_OTHER||Difference|11.6||||0.018|TWO_SIDED|95.0|2.0|21.33|||Cochran-Mantel-Haenszel|||||21.33|2.00|0.018
73850687|NCT00809926|147248184|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.4||||0.028|TWO_SIDED|95.0|-6.34|-0.37|||ANCOVA|||||-0.37|-6.34|0.028
73850688|NCT00809926|147248185|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.1||||0.04|TWO_SIDED|95.0|-6.02|-0.14|||GENMOD|Based on a generalized estimating equations using SAS procedure GENMOD.||||-0.14|-6.02|0.040
73850689|NCT00809926|147248186|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.7||||0.004|TWO_SIDED|95.0|-14.38|-2.93|||ANCOVA|||||-2.93|-14.38|0.004
73850690|NCT00809926|147248187|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.9||||0.006|TWO_SIDED|95.0|-8.37|-1.42|||ANCOVA|||||-1.42|-8.37|0.006
73850691|NCT03265145|147248238|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.87|1.72|||||"Cox proportional hazards model with baseline ICS prior use as a covariate was used to estimate the hazard ratio (HR) and the two-sided 95% Wald confidence interval (CI).~Ratio: Stiolto Respimat/triple therapy."|||1.72|0.87|
73850692|NCT03265145|147248239|OTHER||adjusted annual rate ratio|1.41|||||TWO_SIDED|95.0|0.97|2.04|||||Ratio: Stiolto Respimat/triple therapy|||2.04|0.97|
73850693|NCT03265145|147248240|OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.62|2.0|||||"Cox proportional hazards model with baseline ICS prior use as a covariate was used to estimate the hazard ratio (HR) and the two-sided 95% Wald confidence interval (CI).~Ratio: Stiolto Respimat/triple therapy."|||2.00|0.62|
73850694|NCT03265145|147248241|OTHER||adjusted annual rate ratio|1.08|||||TWO_SIDED|95.0|0.58|2.01|||||Ratio: Stiolto Respimat/triple therapy|||2.01|0.58|
74024147|NCT01658514|147600514|SUPERIORITY_OR_OTHER|||||||0.9444|TWO_SIDED|||||R² for Placebo-adjusted Change from Pre-dose Value in Lactate Versus Metformin Concentration|Pearson Correlation|||||||0.9444
73961777|NCT01149369|147460131|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.72|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.72
74024148|NCT01658514|147600514|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||R² for placebo-adjusted change from pre-dose value in lactate versus metformin concentration|Pearson Correlation|||||||<0.0001
74024149|NCT04325503|147600561|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.0905||||0.015|TWO_SIDED|95.0|0.022|0.159||A priori threshold statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 9||||0.159|0.022|0.015
74024150|NCT04325503|147600562|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.333||||0.694|TWO_SIDED|95.0|-1.55|2.216||A priori threshold for statistical significance is p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 8||||2.216|-1.550|0.694
74024151|NCT04325503|147600563|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|1.444||||0.103|TWO_SIDED|95.0|-0.363|3.252||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 8||||3.252|-0.363|0.103
74024152|NCT04325503|147600564|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-2.09||||0.321|TWO_SIDED|95.0|-6.554|2.372||A priori threshold for statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 10||||2.372|-6.554|0.321
74024153|NCT04325503|147600565|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.185||||0.265|TWO_SIDED|95.0|-0.175|0.544|||t-test, 2 sided|Paired samples t-test, df = 7||||0.544|-0.175|0.265
74024154|NCT04325503|147600566|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|8.143||||0.027|TWO_SIDED|95.0|1.296|15.0||A priori threshold for statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 6||||15.0|1.296|0.0270
74024155|NCT04325503|147600567|OTHER|A comparison is not being made between two different treatment groups.||||||0.153||||||A priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.153
74024156|NCT00144170|147600580|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.5||||0.0001|TWO_SIDED|95.0|12.9|24.0|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||24.0|12.9|0.0001
74024157|NCT00144170|147600581|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
74024158|NCT00144170|147600582|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.9||||0.0001|TWO_SIDED|95.0|18.6|31.1|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||31.1|18.6|0.0001
74024159|NCT00144170|147600583|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.8||||0.0001|TWO_SIDED|95.0|22.5|35.1|||Cochran-Mantel-Haenszel|||||35.1|22.5|0.0001
74024160|NCT00144170|147600584|SUPERIORITY_OR_OTHER||Risk Difference (RD)|29.4||||0.0001|TWO_SIDED|95.0|23.2|35.7|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||35.7|23.2|0.0001
74024161|NCT00144170|147600585|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.6||||0.0001|TWO_SIDED|95.0|20.5|32.6|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||32.6|20.5|0.0001
74024162|NCT00144170|147600586|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.1||||0.0001|TWO_SIDED|95.0|16.2|27.9|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||27.9|16.2|0.0001
74024163|NCT00144170|147600587|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.0||||0.0001|TWO_SIDED|95.0|13.3|24.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||24.7|13.3|0.0001
74024164|NCT00144170|147600588|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7||||0.0001|TWO_SIDED|95.0|13.0|24.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||24.4|13.0|0.0001
74088260|NCT02709486|147729990|SUPERIORITY||Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.2||0.0003|TWO_SIDED|95.0|-1.1|-0.33|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-1.10|0.0003
74024165|NCT00144170|147600589|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.2||||0.0001|TWO_SIDED|95.0|11.7|22.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.7|11.7|0.0001
74024166|NCT00144170|147600590|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.1||||0.0001|TWO_SIDED|95.0|11.7|22.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.4|11.7|0.0001
74024167|NCT00144170|147600591|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.3||||0.0001|TWO_SIDED|95.0|12.0|22.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.5|12.0|0.0001
74024168|NCT00144170|147600592|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.4||||0.0001|TWO_SIDED|95.0|11.2|21.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||21.5|11.2|0.0001
74024169|NCT00144170|147600593|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.2||||0.0001|TWO_SIDED|95.0|11.1|21.3||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||21.3|11.1|0.0001
74024170|NCT00144170|147600594|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.6||||0.0001|TWO_SIDED|95.0|10.6|20.6||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||20.6|10.6|0.0001
74024171|NCT00144170|147600595|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
74024172|NCT00144170|147600596|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
74024173|NCT00144170|147600597|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
74024174|NCT00144170|147600671|SUPERIORITY_OR_OTHER|||||||0.1026||95.0|||||Log Rank|||||||0.1026
74024175|NCT00702143|147600672|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||0.0002
74024176|NCT00702143|147600672|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||<0.0001
74024177|NCT00702143|147600672|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||0.0014
74024178|NCT00702143|147600674|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.||||<0.0001
74024179|NCT00702143|147600674|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||<0.0001
74024180|NCT00702143|147600674|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||<0.0001
73850695|NCT03265145|147248242|OTHER||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||Ratio: Stiolto Respimat/triple therapy|A Cochran-Mantel-Haenszel (CMH) model with baseline ICS prior use as stratum was used to estimate the Risk Ratio (RR) (Stiolto Respimat versus triple therapy) of moderate or severe COPD exacerbations along with 95% CI.||1.64|0.89|
73850696|NCT03265145|147248242|OTHER||Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|-0.022|0.094|||||Ratio: Stiolto Respimat/triple therapy|A Cochran-Mantel-Haenszel (CMH) model with baseline ICS prior use as stratum was used to estimate the Risk Difference (Stiolto Respimat versus triple therapy) of moderate or severe COPD exacerbations along with 95% CI.||0.094|-0.022|
73850697|NCT00802997|147248247|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||||||0.035
73850698|NCT03046927|147248330|EQUIVALENCE|p values were obtained using generalized linear model with GEE for repeated measures.|Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED||||||generalized linear model with dependent||Trend analysis was performed using generalized linear model with GEE for repeated measures.|||||<0.001
73850699|NCT03046927|147248331|OTHER||trend analysis|0.04|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p=0.05|generalized linear model|p values were obtained using generalized linear model with GEE for repeated measures.|Trend analysis was performed using generalized linear model with GEE for repeated measures.|||||<0.01
73850700|NCT03046927|147248332|OTHER|p values were derived from trend analysis using generalized linear models|Mean Difference (Net)|0.507||||0.0241|TWO_SIDED|95.0|0.066|0.947||The p-value was derived from a statistical model adjusted for age, sex, and BMI|General linear models|||||0.947|0.066|0.0241
73850701|NCT03046927|147248333|OTHER|p values were obtained from a generalized linear model with repeated measures|Mean Difference (Net)|10.37||||0.23|TWO_SIDED|95.0|-6.4|27.13||The p-value was derived from a statistical model adjusted for age, sex, and BMI|Regression, Linear|||||27.13|-6.40|0.23
73850702|NCT03046927|147248334|OTHER||trend analysis|0.02|||<|0.001|TWO_SIDED||||||generalized linear model|p values were obtained using generalized linear model with GEE for repeated measures.|||Trend analysis was obtained using generalized linear model GEE.|||<0.001
73850703|NCT01848977|147248359|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Unpaired t-test was used to compare the difference between SrO2 and StO2.||||<0.05
73850704|NCT02522429|147248403|OTHER|||||||0.05||||||Statistic adjusted at familywise level alpha of 0.05 with a Gaussian Random Field Cluster Correction (Z \> 2.7)|t-test, 1 sided|||||||0.05
73850705|NCT02522429|147248404|OTHER||||||<|0.05||||||Statistic adjusted at familywise level alpha of 0.05 with a Gaussian Random Field Cluster Correction (Z \> 2.7). All significant voxels have an associated p-value smaller-or-equal to 0.05 (corrected for multiplicity).|t-test, 1 sided|||||||<0.05
73850706|NCT02522429|147248406|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Maximum CRS-R prior to LIFUP compared to Maximum CRS-R after LIFUP||||<0.05
73850707|NCT01139411|147248410|SUPERIORITY_OR_OTHER|||||||0.06||||||Threshold for significance: 0.05|ANCOVA|||"Null hypothesis was that the amount of weight lost by adolescents in Enhanced Parent Involvement and Minimal Parent involvement would not be significantly different. The study was powered at .8 to achieve a medium effect size (f = .26; partial eta sq. = 0.06).~The end-of-treatment BMI value was the dependent variable, with the baseline BMI value entered as a covariate."||||0.06
73850708|NCT01139411|147248411|SUPERIORITY_OR_OTHER|||||||0.58||||||Threshold for significance: 0.05|ANCOVA|||The end-of-treatment value was the dependent variable, with the baseline value entered as a covariate.||||0.58
73850709|NCT01139411|147248412|SUPERIORITY_OR_OTHER|||||||0.19||||||Threshold for significance: 0.05|ANCOVA|||||||0.19
73850710|NCT01139411|147248413|SUPERIORITY_OR_OTHER|||||||0.72||||||Threshold for significance: 0.05|ANCOVA|||||||0.72
73850711|NCT01139411|147248414|SUPERIORITY_OR_OTHER|||||||0.41|||||||ANCOVA|||||||0.41
73850712|NCT01139411|147248415|SUPERIORITY_OR_OTHER|||||||0.01||||||Threshold for significance: 0.05|ANCOVA|||||||0.01
73850713|NCT01139411|147248416|SUPERIORITY_OR_OTHER|||||||0.61||||||Threshold for significance: 0.05|ANCOVA|||||||0.61
73850714|NCT01521923|147248417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.719|||=|0.112|TWO_SIDED|95.0|0.881|3.354|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order beginning with the CZP standard maintenance dosing (200 mg Q2W) + MTX group vs the CZP stopped dosing (PBO) + MTX group. If this analysis was statistically significant at the alpha =0.05 level, then an additional comparison of the CZP reduced frequency dosing (200 mg Q4W) + MTX group vs the CZP stopped dosing + MTX group was performed with testing at the alpha =0.05 level||3.354|0.881|=0.112
73850715|NCT01521923|147248417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.889|||=|0.041|TWO_SIDED|95.0|1.026|3.48|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order. A hierarchical test procedure was applied to protect the Overall significance level for the multiplicity of endpoints. Hypothesis testing was performed in the following predefined order, each at a 2-sided 95 % alpha level||3.480|1.026|=0.041
73850716|NCT01665911|147248467|SUPERIORITY_OR_OTHER|||||||0.049||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||Based on prior studies using a variety of products in this model, the within-product standard deviation of %SMH recovery is estimated to be 13% and the correlation between products is expected to be approximately 0.5. With a sample size of 28 subjects in a 5-way crossover study, the study will have 80% power to detect a %SMH recovery difference of 8.6%, assuming two-sided tests each conducted at a 5% significance level.||||0.0490
73850717|NCT01665911|147248467|SUPERIORITY_OR_OTHER|||||||0.19||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.19
73850718|NCT01665911|147248467|SUPERIORITY_OR_OTHER|||||||0.0017||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0017
73850719|NCT01665911|147248467|SUPERIORITY_OR_OTHER|||||||0.0092||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0092
73850720|NCT01665911|147248467|SUPERIORITY_OR_OTHER|||||||0.45||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.45
73850721|NCT01665911|147248467|SUPERIORITY_OR_OTHER|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.18
73850722|NCT01665911|147248467|SUPERIORITY_OR_OTHER|||||||0.47||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.47
73850723|NCT01665911|147248467|SUPERIORITY_OR_OTHER|||||||0.0423||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0423
74024181|NCT00702143|147600674|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0003
74024182|NCT05087030|147600677|NON_INFERIORITY|The analysis was performed with an ANCOVA model with %CfB in lumbar spine BMD at Week 52 as the dependent variable, covariates were treatment arm (RGB-14-P and US-licensed Prolia).|Estimated Difference|0.18|||||TWO_SIDED|90.0|-0.465|0.826|||ANCOVA|||||0.826|-0.465|
73850724|NCT01665911|147248467|SUPERIORITY_OR_OTHER|||||||0.15||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.15
74024183|NCT05087030|147600677|SUPERIORITY|Non-Superiority Test|Estimated Difference|0.55|||||TWO_SIDED|90.0|-0.099|1.191|||ANCOVA|||||1.191|-0.099|
74024184|NCT05087030|147600678|OTHER||Geometric mean ratio|1.01||||0.494|TWO_SIDED|95.0|0.978|1.046|||ANCOVA|||Comparison between Study Treatment Groups||1.046|0.978|0.494
74088261|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|2.57||0.6427|TWO_SIDED|95.0|-3.9|6.29|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||6.29|-3.90|0.6427
73850725|NCT01665911|147248467|SUPERIORITY_OR_OTHER|||||||0.54||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.54
73850726|NCT01665911|147248468|SUPERIORITY_OR_OTHER|||||||0.24||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||||||0.24
73850727|NCT01665911|147248468|SUPERIORITY_OR_OTHER|||||||0.17||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.17
73850728|NCT01665911|147248468|SUPERIORITY_OR_OTHER|||||||0.0008||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0008
73850729|NCT01665911|147248468|SUPERIORITY_OR_OTHER|||||||0.0003||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0003
73850730|NCT01665911|147248468|SUPERIORITY_OR_OTHER|||||||0.24||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA|||||||0.24
73850731|NCT01665911|147248468|SUPERIORITY_OR_OTHER|||||||0.26||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.26
73850732|NCT01665911|147248468|SUPERIORITY_OR_OTHER|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.18
73961778|NCT01149369|147460132|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.001|TWO_SIDED|95.0|-1.2|-0.3|||ANCOVA|||||-0.3|-1.2|0.001
73961779|NCT01149369|147460133|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.04
73961780|NCT01149369|147460134|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.14|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.14
73961781|NCT01149369|147460135|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.07|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||||0.0|-1.0|0.07
73961782|NCT01149369|147460136|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.19|TWO_SIDED|95.0|-0.8|0.2|||ANCOVA|||||0.2|-0.8|0.19
73961783|NCT01149369|147460137|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||-0.0|-0.9|0.04
73961784|NCT01149369|147460138|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.02|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||||-0.1|-1.0|0.02
73961785|NCT01149369|147460139|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.06|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.06
73961786|NCT01149369|147460140|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.09|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.09
73961787|NCT01149369|147460141|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.17|TWO_SIDED|95.0|-7.0|0.1|||ANCOVA|||||0.1|-7|0.17
73961788|NCT01149369|147460142|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.009|TWO_SIDED|95.0|-1.1|-0.2|||ANCOVA|||||-0.2|-1.1|0.009
73961789|NCT01149369|147460143|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.004|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||||-0.2|-1.2|0.004
73961790|NCT01149369|147460144|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.1|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.10
73850733|NCT01665911|147248468|SUPERIORITY_OR_OTHER|||||||0.0269||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0269
73961791|NCT01149369|147460145|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.13|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.13
73961792|NCT01149369|147460146|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.98|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||||0.4|-0.5|0.98
73961793|NCT01149369|147460147|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.007|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.007
73961794|NCT01149369|147460148|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.06|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.06
73961795|NCT01149369|147460149|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|||||-0.2|-1.0|0.001
73961796|NCT01149369|147460150|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.28|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||||0.2|-0.6|0.28
73961797|NCT01149369|147460151|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||||0.0|-1.0|0.05
73850734|NCT01665911|147248468|SUPERIORITY_OR_OTHER|||||||0.0142||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0142
73961798|NCT01149369|147460152|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.08
74024185|NCT05087030|147600679|OTHER||Estimated difference|-0.31||||0.199|TWO_SIDED|95.0|-0.792|0.165|||Mixed model repeated measures|||at Week 26||0.165|-0.792|0.199
73850735|NCT01665911|147248468|SUPERIORITY_OR_OTHER|||||||0.81||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.81
73850736|NCT01665911|147248469|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||||||0.0000
73850737|NCT01665911|147248469|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0000
73850738|NCT01665911|147248469|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0000
73850739|NCT01665911|147248469|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0000
73850740|NCT01665911|147248469|SUPERIORITY_OR_OTHER|||||||0.14||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA|||||||0.14
73850741|NCT01665911|147248469|SUPERIORITY_OR_OTHER|||||||0.0012||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0012
73850742|NCT01665911|147248469|SUPERIORITY_OR_OTHER|||||||0.19||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.19
73850743|NCT01665911|147248469|SUPERIORITY_OR_OTHER|||||||0||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0000
73850744|NCT01665911|147248469|SUPERIORITY_OR_OTHER|||||||0.0075||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0075
73850745|NCT01665911|147248469|SUPERIORITY_OR_OTHER|||||||0.0444||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0444
73850746|NCT03703232|147248471|SUPERIORITY|||||||0.092|||||||Wilcoxon signed-rank test|||||||0.092
73850747|NCT03703232|147248472|SUPERIORITY|||||||0.76|||||||Wilcoxon signed-rank test|||||||0.760
73850748|NCT03703232|147248473|SUPERIORITY|||||||0.007|||||||Wilcoxon signed-rank test|||||||0.007
73850749|NCT03703232|147248474|SUPERIORITY|||||||0.003|||||||Wilcoxon signed-rank test|||||||0.003
73850750|NCT03703232|147248475|SUPERIORITY|||||||0.861|||||||Wilcoxon signed-rank test|||||||0.861
73850751|NCT03703232|147248477|SUPERIORITY|||||||0.405|||||||Wilcoxon signed-rank test|||||||0.405
73850752|NCT03703232|147248478|SUPERIORITY|||||||0.798|||||||Wilcoxon signed-rank test|||||||0.798
73850753|NCT03703232|147248479|SUPERIORITY|||||||0.382|||||||Wilcoxon signed-rank test|||||||0.382
73850754|NCT03703232|147248480|SUPERIORITY|||||||0.179|||||||Wilcoxon signed-rank test|||||||0.179
73850755|NCT03703232|147248481|SUPERIORITY|||||||0.984|||||||Wilcoxon signed-rank test|||||||0.984
73850756|NCT03726658|147248497|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|2.24||0.98|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Since this was a phase 1 study no power calculation was performed.||||0.98
74024186|NCT05087030|147600679|OTHER||Estimated difference|-0.16||||0.543|TWO_SIDED|95.0|-0.68|0.358|||mixed model repeated measures|||At Week 52||0.358|-0.680|0.543
73850757|NCT03726658|147248497|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.|Median Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.25||0.25|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Since this was a phase 1 study no power calculation was performed.||||0.25
73850758|NCT03726658|147248497|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|2.26||0.93|TWO_SIDED|||||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).||||0.93
73850759|NCT03726658|147248498|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group|Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|2.02||0.43|TWO_SIDED|||||a priori threshold for statistical significance was \<0.05|Mixed Models Analysis|||Chane from baseline in treated group compared to change from baseline in placebo group. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
73850760|NCT03726658|147248498|EQUIVALENCE|Change from baseline in treated group compared to change in baseline in placebo group|Median Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.02||0.84|TWO_SIDED|||||The a priori threshold for statistical significance was P \<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change in placebo group. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.84
74024187|NCT05087030|147600680|OTHER||Estimated Difference|0.03||||0.929|TWO_SIDED|95.0|-0.703|0.769|||mixed model for repeated measures|||Week 26||0.769|-0.703|0.929
74024188|NCT00609622|147600702|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.705||||0.9963|TWO_SIDED|95.0|1.272|5.751|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), Baseline Lactate Dehydrogenase (LDH): greater than (\>) 1.5 vs. less than or equal to (\<=) 1.5 \* upper limit of normal range (ULN), and Prior Adjuvant Treatment (yes vs. no).||5.751|1.272|0.9963
74024189|NCT00609622|147600703|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.618||||0.9289|TWO_SIDED|95.0|0.845|3.096|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for ECOG Performance Status (0 vs. 1), Baseline LDH: \>1.5 vs. \<=1.5 \* ULN, and Prior Adjuvant Treatment (yes vs. no).||3.096|0.845|0.9289
74024190|NCT00609622|147600706|SUPERIORITY_OR_OTHER||F-Distribution|3.956||||0.5898|TWO_SIDED|95.0|-10.412|18.324|||Chi-squared|||||18.324|-10.412|0.5898
74024191|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.0515|TWO_SIDED|95.0|-2.82|0.01|||t-test, 2 sided|||Differences in PWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.01|-2.82|0.0515
74024192|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.45||||0.0876|TWO_SIDED|95.0|-3.11|0.22|||t-test, 2 sided|||Differences in PWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.22|-3.11|0.0876
74024193|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.81||||0.0522|TWO_SIDED|95.0|-3.64|0.02|||t-test, 2 sided|||Differences in PWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.02|-3.64|0.0522
74024194|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.64||||0.1339|TWO_SIDED|95.0|-3.81|0.52|||t-test, 2 sided|||Differences in PWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||0.52|-3.81|0.1339
74024195|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05||||0.4233|TWO_SIDED|95.0|-3.68|1.57|||t-test, 2 sided|||Differences in PWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||1.57|-3.68|0.4233
74024196|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.97||||0.2211|TWO_SIDED|95.0|-5.18|1.24|||t-test, 2 sided|||Differences in PWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.24|-5.18|0.2211
74024197|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41||||0.8184|TWO_SIDED|95.0|-3.22|4.04|||t-test, 2 sided|||Differences in PWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||4.04|-3.22|0.8184
74024198|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.9||||0.038|TWO_SIDED|95.0|0.57|17.23|||t-test, 2 sided|||Differences in PWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||17.23|0.57|0.0380
74024199|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6||||0.3266|TWO_SIDED|95.0|-6.61|17.81|||t-test, 2 sided|||Differences in PWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||17.81|-6.61|0.3266
74024200|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.75||||0.4667|TWO_SIDED|95.0|-16.26|27.76|||t-test, 2 sided|||Differences in PWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||27.76|-16.26|0.4667
74024201|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in PWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
74024202|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.5587|TWO_SIDED|95.0|-2.8|1.52|||t-test, 2 sided|||Differences in PWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.52|-2.80|0.5587
74024203|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.6122|TWO_SIDED|95.0|-1.37|0.81|||t-test, 2 sided|||Differences in SWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.81|-1.37|0.6122
74024204|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.4642|TWO_SIDED|95.0|-1.87|0.86|||t-test, 2 sided|||Differences in SWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.86|-1.87|0.4642
74024205|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94||||0.2105|TWO_SIDED|95.0|-2.41|0.54|||t-test, 2 sided|||Differences in SWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.54|-2.41|0.2105
74024206|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.195|TWO_SIDED|95.0|-0.57|2.76|||t-test, 2 sided|||Differences in SWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||2.76|-0.57|0.1950
74024207|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.5779|TWO_SIDED|95.0|-1.55|2.75|||t-test, 2 sided|||Differences in SWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.75|-1.55|0.5779
74024208|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.6314|TWO_SIDED|95.0|-2.15|3.5|||t-test, 2 sided|||Differences in SWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||3.50|-2.15|0.6314
74024209|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.7554|TWO_SIDED|95.0|-2.85|3.87|||t-test, 2 sided|||Differences in SWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||3.87|-2.85|0.7554
74024210|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.94||||0.3781|TWO_SIDED|95.0|-13.22|5.34|||t-test, 2 sided|||Differences in SWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||5.34|-13.22|0.3781
74024211|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.85||||0.5715|TWO_SIDED|95.0|-13.83|8.13|||t-test, 2 sided|||Differences in SWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||8.13|-13.83|0.5715
74024212|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.58||||0.1271|TWO_SIDED|95.0|-19.08|3.93|||t-test, 2 sided|||Differences in SWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||3.93|-19.08|0.1271
74024213|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in SWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
74024214|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.6785|TWO_SIDED|95.0|-1.03|1.58|||t-test, 2 sided|||Differences in SWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.58|-1.03|0.6785
74024215|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.4623|TWO_SIDED|95.0|-1.63|0.74|||t-test, 2 sided|||Differences in EWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.74|-1.63|0.4623
74024216|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.9302|TWO_SIDED|95.0|-1.31|1.2|||t-test, 2 sided|||Differences in EWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||1.20|-1.31|0.9302
73961799|NCT01149369|147460153|SUPERIORITY|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.53|TWO_SIDED|95.0|-1.1|0.6|||ANCOVA|||||0.6|-1.1|0.53
74024217|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.7502|TWO_SIDED|95.0|-1.84|1.33|||t-test, 2 sided|||Differences in EWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||1.33|-1.84|0.7502
74024218|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.9335|TWO_SIDED|95.0|-2.12|1.95|||t-test, 2 sided|||Differences in EWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.95|-2.12|0.9335
74024219|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.9191|TWO_SIDED|95.0|-2.4|2.17|||t-test, 2 sided|||Differences in EWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.17|-2.40|0.9191
73961800|NCT01149369|147460154|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.38|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|||||0.5|-1.3|0.38
74024220|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.675|TWO_SIDED|95.0|-3.46|2.27|||t-test, 2 sided|||Differences in EWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||2.27|-3.46|0.6750
74024221|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.88||||0.5874|TWO_SIDED|95.0|-4.2|2.43|||t-test, 2 sided|||Differences in EWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||2.43|-4.20|0.5874
74024222|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.27||||0.4507|TWO_SIDED|95.0|-7.53|16.06|||t-test, 2 sided|||Differences in EWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||16.06|-7.53|0.4507
74024223|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.9||||0.3087|TWO_SIDED|95.0|-4.28|12.08|||t-test, 2 sided|||Differences in EWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||12.08|-4.28|0.3087
73961801|NCT01149369|147460155|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-2.2||||0.09|TWO_SIDED|95.0|-4.7|0.4|||ANCOVA|||||0.4|-4.7|0.09
73961802|NCT01149369|147460156|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.8||||0.28|TWO_SIDED|95.0|-5.2|1.5|||ANCOVA|||||1.5|-5.2|0.28
74024224|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.9635|TWO_SIDED|95.0|-16.26|15.76|||t-test, 2 sided|||Differences in EWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||15.76|-16.26|0.9635
74024225|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in EWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
74024226|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.6699|TWO_SIDED|95.0|-2.37|1.53|||t-test, 2 sided|||Differences in EWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.53|-2.37|0.6699
73901406|NCT05508074|147332539|OTHER|the primary endpoint was safety hence the study was not powered to show efficacy. statistical analysis was performed to detect signal of efficacy.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|3.45||0.923|TWO_SIDED|95.0|-7.27|6.6|||ANCOVA|adjusted on baseline ALSFRS-R and treatment.||primary analysis results based on estimand 1 (see attached SAP)||6.60|-7.27|0.923
73901407|NCT05508074|147332539|OTHER|FAS post hoc|Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|3.3||0.65|TWO_SIDED|95.0|-5.1|8.2||post hoc analysis on the FAS population, adjusted on baseline NfL on top of previous parameters|ANCOVA|||post hoc analysis adjusted on baseline NfL on top of previous parameters||8.2|-5.1|0.65
73901408|NCT05508074|147332540|OTHER|the primary endpoint was safety hence the study was not powered to show efficacy. statistical analysis was performed to detect signal of efficacy.|Mean Difference (Final Values)|-0.118||||0.398|TWO_SIDED|95.0|-0.408|0.186|||binomial exact method|||primary analysis results based on estimand 1 (see attached SAP)||0.186|-0.408|0.398
73901409|NCT05508074|147332541|OTHER|the primary endpoint was safety hence the study was not powered to show efficacy. statistical analysis was performed to detect signal of efficacy.|Mean Difference (Final Values)|-0.029||||0.835|TWO_SIDED|95.0|-0.326|0.271|||binomial exact method|||calculation based on estimand 1 (see SAP)||0.271|-0.326|0.835
73901410|NCT05508074|147332542|OTHER|the primary endpoint was safety hence the study was not powered to show efficacy. statistical analysis was performed to detect signal of efficacy.|Mean Difference (Final Values)|5.31|STANDARD_ERROR_OF_MEAN|7.47||0.481|TWO_SIDED|95.0|-9.72|20.34|||ANCOVA|||based on estimand 1 (see SAP). change of SVC percentage from baseline to 6 months||20.34|-9.72|0.481
73901411|NCT05508074|147332552|OTHER||adjusted geometric mean ratio|1.04|STANDARD_ERROR_OF_MEAN|1.08||0.609|TWO_SIDED|95.0|0.89|1.21|||ANCOVA|||based on available data at V4||1.21|0.89|0.609
73901412|NCT05040971|147332589|SUPERIORITY|Week 52 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment as factor and baseline body weight as covariate.|Treatment difference|-11.19|||<|0.0001|TWO_SIDED|95.0|-12.97|-9.42|||ANCOVA|||Treatment policy estimand||-9.42|-12.97|<0.0001
73901413|NCT05040971|147332590|SUPERIORITY|Week 52 responses were analysed using a logistic regression model with randomised treatment as factor and baseline glycosylated haemoglobin (HbA1c) and fasting plasma glucose (FPG) as covariates.|Odds Ratio (OR)|19.81|||<|0.0001|TWO_SIDED|95.0|8.68|45.21|||Regression, Logistic|||Treatment policy estimand||45.21|8.68|<0.0001
74024227|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.34||||0.0055|TWO_SIDED|95.0|-3.98|-0.7|||t-test, 2 sided|||Differences in FWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||-0.70|-3.98|0.0055
74024228|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04||||0.2793|TWO_SIDED|95.0|-2.92|0.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.85|-2.92|0.2793
74024229|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.2999|TWO_SIDED|95.0|-3.17|0.99|||t-test, 2 sided|||Differences in FWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.99|-3.17|0.2999
73930710|NCT03238911|147391295|SUPERIORITY||Mean Difference (Final Values)|0.064||||0.0472|TWO_SIDED|95.0|0.001|0.127|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.127|0.001|0.0472
73930711|NCT03238911|147391295|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.005|TWO_SIDED|95.0|0.031|0.171|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.171|0.031|0.0050
73930712|NCT03238911|147391295|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.0061|TWO_SIDED|95.0|0.029|0.172|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.172|0.029|0.0061
74024230|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.27||||0.327|TWO_SIDED|95.0|-3.82|1.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.29|-3.82|0.3270
74024231|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.9779|TWO_SIDED|95.0|-2.39|2.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.45|-2.39|0.9779
74024232|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.8344|TWO_SIDED|95.0|-4.25|3.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||3.45|-4.25|0.8344
74024233|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.46||||0.5494|TWO_SIDED|95.0|-3.5|6.41|||t-test, 2 sided|||Differences in FWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||6.41|-3.50|0.5494
73961803|NCT01149369|147460157|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.6||||0.3|TWO_SIDED|95.0|-4.6|1.4|||ANCOVA|||||1.4|-4.6|0.30
73850761|NCT03726658|147248499|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 9|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|2.65||0.69|TWO_SIDED|||||A priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.69
73850762|NCT03726658|147248499|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 9|Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.66||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.44
73850763|NCT03726658|147248499|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 9|Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.66||0.43|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
73850764|NCT03726658|147248499|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15|Median Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|2.65||0.55|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculaton was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.55
73850765|NCT03726658|147248499|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15.|Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.66||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.44
73850766|NCT03726658|147248499|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15|Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|2.69||0.56|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.56
73850767|NCT03726658|147248499|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|2.74||0.8|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.80
73850768|NCT03726658|147248499|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Median Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.74||0.45|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.45
73850769|NCT03726658|147248499|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|2.77||0.67|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.67
73850770|NCT03726658|147248500|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 11|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|2.36||0.43|TWO_SIDED|||||a priori threshold for statistical significance was p\>0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 11. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
73850771|NCT03726658|147248500|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 11|Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.38||0.59|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 11. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.59
73850772|NCT03726658|147248500|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 14|Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|2.44||0.35|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 14, Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.35
73961804|NCT01149369|147460158|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-21.2||||0.4|TWO_SIDED|95.0|-70.5|28.1|||ANCOVA|||||28.1|-70.5|0.40
74024234|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.0136|TWO_SIDED|95.0|3.15|22.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||22.85|3.15|0.0136
73961805|NCT01149369|147460159|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.2||||0.28|TWO_SIDED|95.0|-12.0|3.5|||ANCOVA|||||3.5|-12.0|0.28
74024235|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.78||||0.0247|TWO_SIDED|95.0|2.26|25.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||25.29|2.26|0.0247
74024236|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.3527|TWO_SIDED|95.0|-12.91|22.91|||t-test, 2 sided|||Differences in FWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||22.91|-12.91|0.3527
74024237|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in FWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
74024238|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.76||||0.1309|TWO_SIDED|95.0|-4.05|0.53|||t-test, 2 sided|||Differences in FWB between treatment arms (EOT) was analyzed from a two-sample t-test.||0.53|-4.05|0.1309
74024239|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.051|TWO_SIDED|95.0|-2.72|0.01|||t-test, 2 sided|||Differences in CCS between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.01|-2.72|0.0510
74024240|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.3858|TWO_SIDED|95.0|-2.44|0.95|||t-test, 2 sided|||Differences in CCS between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.95|-2.44|0.3858
73850773|NCT03726658|147248500|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 14|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.48||0.82|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 14. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.82
73850774|NCT03726658|147248500|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 18|Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|2.62||0.61|TWO_SIDED||||||Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 18. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.61
73901428|NCT02720094|147332765|SUPERIORITY||A bias-adjusted hazard ratio|0.34||||0.0005|TWO_SIDED|95.0|0.18|0.62|||Regression, Cox||The bias-adjusted hazard ratio, CI, and p-value account for the group-sequential trial design and the early stopping time.|||0.62|0.18|0.0005
73901429|NCT02720094|147332765|SUPERIORITY||Hazard Ratio (HR)|0.328||||0.0005|TWO_SIDED|95.0|0.18|0.61|||Regression, Cox||The unadjusted hazard ratio is based on a Cox proportional hazards model stratified by region.|||0.61|0.18|0.0005
73901430|NCT02720094|147332767|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.1|0.45||The P-Values are two-sided.|Regression, Cox|||The analysis population Injection Step 2 Efficacy consists of the subset of the mITT population who received at least one injection and had at least one HIV test result after the week 5 injection visit.||0.45|0.10|<0.001
73901431|NCT01302834|147332789|NON_INFERIORITY|The non-inferiority margin was set at 1.45 (hazard ratio scale; IMRT + Cetuximab / IMRT + Cisplatin). If the upper limit of the 95% confidence interval was \<1.45, non-inferiority would be concluded. Design was based on a group sequential design with 3 interim analyses, one-sided 0.05, and 80% power.|Hazard Ratio (HR)|1.45|||||ONE_SIDED|95.0||1.94|||||Reference level = IMRT + Cisplatin|||1.94||
73901432|NCT01302834|147332790|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.0002|TWO_SIDED|95.0|1.29|2.29|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin|||2.29|1.29|0.0002
73901433|NCT01302834|147332791|SUPERIORITY||Hazard Ratio (HR)|2.05||||0.0005|TWO_SIDED|95.0|1.35|3.1|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin|||3.10|1.35|0.0005
73901434|NCT01302834|147332792|SUPERIORITY||Hazard Ratio (HR)|1.49||||0.09|TWO_SIDED|95.0|0.94|2.36||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin|||2.36|0.94|0.09
73901435|NCT01302834|147332793|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.61|1.58||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin|||1.58|0.61|0.95
73901436|NCT01302834|147332795|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.0
73901437|NCT01302834|147332803|SUPERIORITY|||||||0.79||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.79
73901438|NCT01302834|147332806|SUPERIORITY|||||||0.5438||||||One-sided significance level = 0.05|t-test, 1 sided|||||||0.5438
73901439|NCT01302834|147332810|SUPERIORITY|||||||0.7108||||||One-sided significance level = 0.05|t-test, 1 sided|||||||0.7108
73901440|NCT03735238|147332827|OTHER|Not applicable. No statistical test was performed for this outcome.||||||||||||||||This is a single arm implementation trial with no comparison group. This outcome represents the reach/penetration of the implementation at each site over the trial duration. We did not perform power calculation. There was no null hypothesis stated. Our aim was to enroll at least 28 patients per site in this implementation trial during regular outpatient rheumatology clinic visits. No statistical test was performed for this outcome.|Our aim was to enroll at least 28 patients per site in this implementation trial during regular outpatient rheumatology clinic visits. No statistical test was performed for this outcome.|||
74024241|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.88||||0.3943|TWO_SIDED|95.0|-2.9|1.15|||t-test, 2 sided|||Differences in CCS between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||1.15|-2.90|0.3943
74024242|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.3499|TWO_SIDED|95.0|-3.53|1.27|||t-test, 2 sided|||Differences in CCS between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.27|-3.53|0.3499
74024243|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.9567|TWO_SIDED|95.0|-2.64|2.5|||t-test, 2 sided|||Differences in CCS between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.50|-2.64|0.9567
74024244|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.77||||0.2901|TWO_SIDED|95.0|-5.12|1.58|||t-test, 2 sided|||Differences in CCS between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.58|-5.12|0.2901
73850775|NCT03726658|147248500|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 18|Median Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.69||0.47|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 18. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.47
73850776|NCT03726658|147248500|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|2.48||0.76|TWO_SIDED||||||Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 21. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.76
73850777|NCT03726658|147248500|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Median Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.51||0.99|TWO_SIDED|||||Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 21. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.99
73850778|NCT00090779|147248532|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.005
73850779|NCT00090779|147248533|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
73850780|NCT01434654|147248579|SUPERIORITY_OR_OTHER|||||||0.99||||||P-value for arm\*time interaction fixed effect.|Mixed Models Analysis|49 datapoints included from baseline, 6 months, and 12 months visits (low CNS penetrance n=14; high CNS penetrance n=35)||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm\*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.||||0.99
73850781|NCT01434654|147248580|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Change in NAA/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.58
73850782|NCT01434654|147248580|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Change in Cr/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.44
73901444|NCT04711837|147332879|NON_INFERIORITY|Non-inferiority margin equals to -8%|Risk Difference (RD)|-0.0057|STANDARD_ERROR_OF_MEAN|0.0246|||TWO_SIDED|95.0|-0.054|0.042||Non-inferiority margin equals to -8%: 95% CI; (-5.4%, 4.2%)|Farrington-Manning method|||||0.042|-0.054|
73850783|NCT01434654|147248580|SUPERIORITY_OR_OTHER|||||||0.86|||||||ANOVA|||Change in Cho/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.86
73850784|NCT01434654|147248580|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||Change in mIo/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.98
73850785|NCT01434654|147248581|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.16
73850786|NCT01434654|147248581|SUPERIORITY_OR_OTHER|||||||0.09|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.09
73850787|NCT01434654|147248581|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.06
73850788|NCT01434654|147248581|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.68
74024245|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07||||0.5857|TWO_SIDED|95.0|-5.05|2.92|||t-test, 2 sided|||Differences in CCS between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||2.92|-5.05|0.5857
74024246|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.9635|TWO_SIDED|95.0|-12.56|12.02|||t-test, 2 sided|||Differences in CCS between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||12.02|-12.56|0.9635
74024247|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.685|TWO_SIDED|95.0|-15.36|10.56|||t-test, 2 sided|||Differences in CCS between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||10.56|-15.36|0.6850
74024248|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.75||||0.4968|TWO_SIDED|95.0|-19.23|11.73|||t-test, 2 sided|||Differences in CCS between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||11.73|-19.23|0.4968
74024249|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in CCS between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
73901467|NCT02486718|147332931|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.848||||0.0683|TWO_SIDED|95.0|0.71|1.013|||Log Rank|||||1.013|0.710|0.0683
73901468|NCT02486718|147332932|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.691|0.998||||||||0.998|0.691|
73901469|NCT02486718|147332933|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.704|||||TWO_SIDED|95.0|0.545|0.91||||||||0.910|0.545|
73901470|NCT02486718|147332935|SUPERIORITY||Difference in event-free rates|5.98|||||TWO_SIDED|95.0|-0.28|12.23||||||||12.23|-0.28|
73901471|NCT02486718|147332936|SUPERIORITY||Difference in event-free rates|6.65|||||TWO_SIDED|95.0|-0.06|13.36||||||||13.36|-0.06|
73961806|NCT01149369|147460160|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.4||||0.47|TWO_SIDED|95.0|-4.1|8.9|||ANCOVA|||||8.9|-4.1|0.47
73850789|NCT01434654|147248581|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.58
73850790|NCT00703963|147248597|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||0.20
73850791|NCT00703963|147248598|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||0.05
73850792|NCT00703963|147248599|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||<0.001
73850793|NCT00402324|147248602|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline\*Visit Therapy\*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses-the probability of simultaneously rejecting both co-primary null hypotheses-for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.||||<0.001
73850794|NCT00402324|147248603|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline\*Visit Therapy\*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses-the probability of simultaneously rejecting both co-primary null hypotheses-for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.||||0.022
73850795|NCT00402324|147248604|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Fisher Exact|||||||0.100
73850796|NCT00402324|147248605|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Fisher Exact|||||||0.048
73850797|NCT00402324|147248606|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= TRT + Pooled Investigator + Baseline.||||||0.056
73850798|NCT00402324|147248608|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value for Total Cholesterol Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.657
73850799|NCT00402324|147248608|SUPERIORITY_OR_OTHER|||||||0.924||95.0||||P-value for Low Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.924
73850800|NCT00402324|147248608|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for High Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.122
73850801|NCT00402324|147248609|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||P-value for Fasting Triglycerides Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.293
73850802|NCT00402324|147248610|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Fasting Blood Glucose Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.007
73850803|NCT00402324|147248611|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Bilirubin Total Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.046
73850804|NCT00402324|147248612|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline||||||<0.001
73850805|NCT00402324|147248613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline||||||<0.001
73850806|NCT00402324|147248614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73850807|NCT04677543|147248648|SUPERIORITY||Percentage Difference|10.4||||0.2819|TWO_SIDED|95.0|-8.6|29.5|||Standardized Logistic Regression||The percentage difference and confidence intervals are estimated by standardized logistic regression with treatment group and history of MAC lung infection as factors in the model.|||29.5|-8.6|0.2819
73850808|NCT04677543|147248649|SUPERIORITY||Percentage Difference|6.1||||0.508|TWO_SIDED|95.0|-11.9|24.1|||Standardized Logistic Regression||The percentage difference and confidence intervals are estimated by standardized logistic regression with treatment group and history of MAC lung infection as factors in the model.|||24.1|-11.9|0.5080
73850809|NCT04677543|147248650|SUPERIORITY||Percentage Difference|16.7||||0.0712|TWO_SIDED|95.0|-1.4|34.9|||Standardized Logistic Regression|||||34.9|-1.4|0.0712
73850810|NCT04677543|147248651|SUPERIORITY||Least Square Mean Difference|4.48||||0.1073|TWO_SIDED|95.0|-0.97|9.93|||ANCOVA|||||9.93|-0.97|0.1073
73850811|NCT04677543|147248652|SUPERIORITY||Least Square Mean Difference|-0.4||||0.613|TWO_SIDED|95.0|-2.2|1.3|||ANCOVA|||||1.3|-2.2|0.6130
73850812|NCT04677543|147248653|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.3542|TWO_SIDED|95.0|0.79|1.92|||Regression, Cox||A Cox regression model was applied to calculate the hazard ratio. The model included effects for treatment and history of MAC lung infection (initial or subsequent).|||1.92|0.79|0.3542
73850813|NCT04677543|147248654|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.1583|TWO_SIDED|95.0|0.89|2.06|||Regression, Cox||A Cox regression model was applied to calculate the hazard ratio. The model included effects for treatment and history of MAC lung infection (initial or subsequent).|||2.06|0.89|0.1583
73850814|NCT02520388|147248685|SUPERIORITY|||||||0.05|||||||Mixed model repeated measures analysis|||||||0.05
73850815|NCT02520388|147248686|SUPERIORITY|||||||0.05|||||||Mixed model repeated measures analysis|||||||0.05
73850816|NCT03035864|147248689|SUPERIORITY||difference in LS means|-0.11|||=|0.974|TWO_SIDED|95.0|-6.85|6.63|||ANCOVA|||Frequency statistical analysis||6.63|-6.85|=0.974
73850817|NCT03035864|147248689|SUPERIORITY||Difference in least square means|2.88|||=|0.399|TWO_SIDED|95.0|-3.85|9.61|||ANCOVA|||Statistical analysis related to severity||9.61|-3.85|=0.399
73850818|NCT03035864|147248690|SUPERIORITY||difference in least square means|0.04|||=|0.214|TWO_SIDED|95.0|-0.02|0.1|||ANCOVA|||||0.10|-0.02|=0.214
73850819|NCT03035864|147248694|SUPERIORITY||difference in least square means|-0.43|||=|0.881|TWO_SIDED|95.0|-6.13|5.27|||ANCOVA|||Frequency - week 4||5.27|-6.13|=0.881
73901472|NCT02486718|147332937|SUPERIORITY||Difference in event-free rates|10.67|||||TWO_SIDED|95.0|1.56|19.79||||||||19.79|1.56|
73901473|NCT02486718|147332938|SUPERIORITY||Difference in event-free rates|5.48|||||TWO_SIDED|95.0|-0.94|11.9||||||||11.90|-0.94|
73901474|NCT02486718|147332939|SUPERIORITY||Difference in event-free rates|4.88|||||TWO_SIDED|95.0|-1.94|11.7||||||||11.70|-1.94|
73901475|NCT02486718|147332940|SUPERIORITY||Difference in event-free rates|10.46|||||TWO_SIDED|95.0|1.16|19.76||||||||19.76|1.16|
73901476|NCT02486718|147332941|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.503|||||TWO_SIDED|95.0|0.332|0.761||||||||0.761|0.332|
73850820|NCT03035864|147248694|SUPERIORITY||difference in least square means|-0.31|||=|0.926|TWO_SIDED|95.0|-6.96|6.33|||ANCOVA|||Frequency - week 8||6.33|-6.96|=0.926
73850821|NCT03035864|147248694|SUPERIORITY||difference in least square means|-2.29|||=|0.426|TWO_SIDED|95.0|-7.97|3.38|||ANCOVA|||Frequency - Week 12||3.38|-7.97|=0.426
73850822|NCT03035864|147248694|SUPERIORITY||Difference in least square means|0.62|||=|0.828|TWO_SIDED|95.0|-5.04|6.29|||ANCOVA|||Severity - Week 4||6.29|-5.04|=0.828
73850823|NCT03035864|147248694|SUPERIORITY||difference in least square means|2.86|||=|0.394|TWO_SIDED|95.0|-3.75|9.47|||ANCOVA|||Severity - Week 8||9.47|-3.75|=0.394
73850824|NCT03035864|147248694|SUPERIORITY||difference in least square means|-1.49|||=|0.552|TWO_SIDED|95.0|-6.41|3.44|||ANCOVA|||Severeity - Week 12||3.44|-6.41|=0.552
73850825|NCT03299244|147248699|NON_INFERIORITY|Etelcalcetide was considered non-inferior if the upper bound of the two-sided 95% confidence interval of the treatment difference (Cinacalcet - Etelcalcetide) was smaller than 12%, or if the lower bound of (Etelcalcetide - Cinacalcet) greater than -12%. If this criterion was met, the 2 key secondary endpoints were tested sequentially. If both key secondary endpoints were statistically significant, the other secondary endpoints were to be formally tested at an overall significance level of 0.05.|Treatment Difference|4.52|||||TWO_SIDED|95.0|-3.05|12.09|||||Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|"The analysis was conducted on the full analysis set (637 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment (Cinacalcet - Etelcalcetide), stratified by screening PTH level (\< 900 pg/mL, ≥ 900 pg/mL), screening serum cCa (\< 9.0 mg/dL, ≥ 9.0 mg/dL) measured by the central laboratory, and country (China versus non-China)."||12.09|-3.05|
73850826|NCT03299244|147248700|SUPERIORITY|Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint.|Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.47|2.77|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||2.77|1.47|<0.001
73850827|NCT03299244|147248701|SUPERIORITY|Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint, and superiority was demonstrated for the previous key secondary endpoint.|Odds Ratio (OR)|1.42||||0.033|TWO_SIDED|95.0|1.03|1.96|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||1.96|1.03|0.033
73850828|NCT03299244|147248702|SUPERIORITY||Difference in Least Squares Means|-2.82|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-4.14|-1.5|||Mixed-effects Model Repeated Measures|Model includes treatment group, randomization stratification factors, study week, and study week by treatment as covariates.|Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region. Standard error of the mean is the standard error of the least squares means difference.|||-1.50|-4.14|<0.001
73850829|NCT03299244|147248703|SUPERIORITY||Odds Ratio (OR)|1.16||||0.41|TWO_SIDED|95.0|0.82|1.65|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||1.65|0.82|0.41
73850830|NCT01763333|147248724|SUPERIORITY_OR_OTHER||Slope|0.8728|||||TWO_SIDED|95.0|0.6942|1.0513|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0513|0.6942|
73850831|NCT01763333|147248724|SUPERIORITY_OR_OTHER||Slope|0.9341|||||TWO_SIDED|95.0|0.8277|1.0405|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of solution for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0405|0.8277|
73850832|NCT01763333|147248724|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|112.74|||||TWO_SIDED|90.0|95.579|132.993|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||132.993|95.579|
73901479|NCT04803214|147332963|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
73901480|NCT04803214|147332964|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74024250|NCT00609622|147600708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.5891|TWO_SIDED|95.0|-2.71|1.55|||t-test, 2 sided|||Differences in CCS between treatment arms (EOT) was analyzed from a two-sample t-test.||1.55|-2.71|0.5891
74024251|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.5081|TWO_SIDED|95.0|-2.5|1.24|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||1.24|-2.50|0.5081
73901481|NCT04803214|147332965|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73901484|NCT06372782|147333212|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||Within-Subject Difference in VAS Score at the End of Injection (FAS)||||<0.0001
73901485|NCT04035486|147333242|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.79|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.79|0.49|<0.0001
73961807|NCT01149369|147460161|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.2||||0.68|TWO_SIDED|95.0|-4.5|6.9|||ANCOVA|||||6.9|-4.5|0.68
74024252|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.6977|TWO_SIDED|95.0|-2.67|1.79|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||1.79|-2.67|0.6977
73901486|NCT04035486|147333243|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0002|TWO_SIDED|95.0|0.48|0.8|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.80|0.48|0.0002
73901487|NCT04035486|147333248|OTHER||Percentage of Participants|100.0|||||TWO_SIDED|95.0|88.43|100.0|||Clopper-Pearson|||A 95% CI was calculated on the percentage of participants with a Response or Stable Disease using the exact (Clopper-Pearson) method.||100.00|88.43|
73901488|NCT04035486|147333249|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5238|TWO_SIDED|95.0|0.65|1.24|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).|An adjusted CI of (0.54, 1.51) was computed at the 2-sided 99.84% level, considering a 2-sided significance level of 0.00158 for the overall survival interim analysis, based on the O'Brien and Fleming spending function, assuming 334 deaths for the final overall survival analysis.|1.24|0.65|0.5238
74024253|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.76||||0.0797|TWO_SIDED|95.0|-5.85|0.33|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.33|-5.85|0.0797
73901489|NCT04035486|147333251|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0261|TWO_SIDED|95.0|1.06|2.44|||Regression, Logistic||And odds ratio of greater than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a logistic regression stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||2.44|1.06|0.0261
73901490|NCT04035486|147333253|SUPERIORITY||Least Square Mean Difference|-3.36||||0.1067|TWO_SIDED|95.0|-7.44|0.72|||ANCOVA||A difference in least square means less than 0 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using analysis of covariance with baseline tumor size and time from baseline scan to randomization as covariates and with factors race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.72|-7.44|0.1067
73901491|NCT04035486|147333254|SUPERIORITY||Odds Ratio (OR)|1.33||||0.4483|TWO_SIDED|95.0|0.63|2.81|||Regression, Logistic||An odds ratio greater than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a logistic regression stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||2.81|0.63|0.4483
73901492|NCT04035486|147333255|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0132|TWO_SIDED|95.0|0.52|0.93|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.93|0.52|0.0132
74024254|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.5808|TWO_SIDED|95.0|-5.62|3.17|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||3.17|-5.62|0.5808
74024255|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03||||0.7046|TWO_SIDED|95.0|-6.44|4.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||4.38|-6.44|0.7046
74024256|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.18||||0.2052|TWO_SIDED|95.0|-2.4|10.76|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||10.76|-2.40|0.2052
74024257|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.27||||0.0483|TWO_SIDED|95.0|0.07|16.46|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||16.46|0.07|0.0483
74024258|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.93||||0.6832|TWO_SIDED|95.0|-16.41|24.26|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||24.26|-16.41|0.6832
73901493|NCT04035486|147333256|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0159|TWO_SIDED|95.0|0.56|0.94|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.94|0.56|0.0159
73901494|NCT04035486|147333257|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0157|TWO_SIDED|95.0|0.51|0.93|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.93|0.51|0.0157
73901495|NCT04035486|147333264|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.44|0.83|||Cox proportional hazards model||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.||0.83|0.44|
73901496|NCT04035486|147333265|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.44|0.9|||||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.||0.90|0.44|
73901497|NCT01730937|147333273|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0554|TWO_SIDED|90.0|0.59|1.01|||Log Rank||Reference arm = Sorafenib Alone|Original design: Hypothesized 28% reduction (HR=0.72) with SBRT (corresponds to median OS = 14.5 months). Assuming an exponential distribution and constant hazards, 292 patients were required to reach 238 OS events, with 80% statistical power, a 1-sided α of 0.05. Revised design (see limitations/caveats): For same above hypotheses, at least 155 OS events from 193 randomized patients provided 65% statistical power, with a 1-sided α of 0.05.||1.01|0.59|0.0554
73901498|NCT01730937|147333274|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.034|TWO_SIDED|95.0|0.48|0.99||Two-sided significance level = 0.05|Gray's test||Reference arm = Sorafenib Alone|||0.99|0.48|0.034
73901499|NCT01730937|147333275|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0001|TWO_SIDED|95.0|0.4|0.75||Two-sided significance level=0.05|Log Rank||Reference arm = Sorafenib Alone|||0.75|0.40|0.0001
73901500|NCT03947684|147333283|OTHER|Generalized linear model (GLM) with log link function and exchangeable correlation structure.|||||>|0.05|||||||F-test|||Significance was accepted for p values \<0.05.||||>0.05
73901501|NCT03947684|147333284|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
73901502|NCT03947684|147333284|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||<0.05
73901503|NCT03947684|147333285|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
73901504|NCT03947684|147333285|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||>0.05
73901505|NCT03947684|147333286|OTHER|Repeated measures ANOVA|||||>|0.05|||||||F-test|||Significance was accepted for p values \<0.05.||||>0.05
73901506|NCT03947684|147333287|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data obtained during active pill phase.||||>0.05
73901507|NCT03947684|147333287|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data obtained during inactive pill phase.||||<0.05
73901508|NCT03947684|147333288|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
73901509|NCT03947684|147333288|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||<0.05
73901510|NCT03947684|147333289|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
73901511|NCT03947684|147333289|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||>0.05
73901512|NCT03947684|147333290|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
73901513|NCT03947684|147333290|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||>0.05
74088262|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|2.59||0.4208|TWO_SIDED|95.0|-7.22|3.04|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.04|-7.22|0.4208
73901514|NCT03947684|147333291|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during follicular phase.||||>0.05
73901515|NCT03947684|147333291|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during luteal phase.||||<0.05
73901516|NCT03947684|147333292|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||>0.05
73850833|NCT01763333|147248724|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|52.66|||||TWO_SIDED|90.0|40.488|68.499|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||68.499|40.488|
73850834|NCT01763333|147248724|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|239.63|||||TWO_SIDED|90.0|197.445|290.83|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.||290.830|197.445|
73901517|NCT03947684|147333292|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||>0.05
73901518|NCT03947684|147333293|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||>0.05
74024259|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.9081|TWO_SIDED|95.0|-18.05|20.05|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||20.05|-18.05|0.9081
73901519|NCT03947684|147333293|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||<0.05
73901520|NCT03947684|147333294|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||<0.05
73901521|NCT03947684|147333294|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||<0.05
73901522|NCT03947684|147333295|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from follicular phase.||||>0.05
73901523|NCT03947684|147333295|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from luteal phase.||||>0.05
73901524|NCT03947684|147333297|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from follicular phase.||||>0.05
73901525|NCT03947684|147333297|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from luteal phase.||||>0.05
73901526|NCT03947684|147333298|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from follicular phase.||||>0.05
73901527|NCT03947684|147333298|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained from luteal phase.||||<0.05
73901528|NCT03947684|147333299|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||>0.05
73901529|NCT03947684|147333299|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||>0.05
73901530|NCT03947684|147333300|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||<0.05
73901531|NCT03947684|147333300|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||>0.05
73901532|NCT03947684|147333301|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||<0.05
73901533|NCT03947684|147333301|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||>0.05
73901534|NCT03947684|147333302|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||<|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during active pill phase.||||<0.05
73901535|NCT03947684|147333302|OTHER|Generalized estimating equation (GEE) with log link function and exchangeable correlation structure.|||||>|0.05|||||||Wald test|||Significance was accepted for p values \<0.05. Data is obtained during inactive pill phase.||||>0.05
74024260|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75||||0.7289|TWO_SIDED|95.0|-12.88|16.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||16.38|-12.88|0.7289
74024261|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
73850835|NCT01763333|147248724|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|105.47|||||TWO_SIDED|90.0|85.427|130.208|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||130.208|85.427|
73850836|NCT01763333|147248726|SUPERIORITY_OR_OTHER||Slope|0.8341|||||TWO_SIDED|95.0|0.6485|1.0198|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of tablets for AUC0-inf was analysed.The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0198|0.6485|
73850837|NCT01763333|147248726|SUPERIORITY_OR_OTHER||Slope|0.9149|||||TWO_SIDED|95.0|0.8059|1.0239|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of solution for AUC0-inf was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0239|0.8059|
73850838|NCT01763333|147248726|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean Ratio|86.61|||||TWO_SIDED|90.0|76.529|98.029|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for AUC0-inf. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||98.029|76.529|
73850839|NCT01763333|147248726|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|74.44|||||TWO_SIDED|90.0|66.322|83.562|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||83.562|66.322|
73850840|NCT01763333|147248726|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.25|||||TWO_SIDED|90.0|119.708|157.353|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.||157.353|119.708|
73850841|NCT01763333|147248726|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.48|||||TWO_SIDED|90.0|111.462|121.724|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||121.724|111.462|
73850842|NCT01763333|147248727|SUPERIORITY_OR_OTHER||Slope|0.8428|||||TWO_SIDED|95.0|0.658|1.0275|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC 0- tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0275|0.6580|
73850843|NCT01763333|147248727|SUPERIORITY_OR_OTHER||Slope|0.9307|||||TWO_SIDED|95.0|0.8187|1.0426|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.|This was non confirmatory testing (Single dose). Dose proportionality of solution for AUC0-tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0426|0.8187|
74024262|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74||||0.6921|TWO_SIDED|95.0|-4.43|2.95|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (EOT) was analyzed from a two-sample t-test.||2.95|-4.43|0.6921
73850844|NCT01763333|147248727|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean Ratio|86.16|||||TWO_SIDED|90.0|75.735|98.027|||||Adjusted geometric mean (gMean) ratio.|Relative bioavailability comparison Tab. fed (T1) : Tab. fasted (R1) for AUC 0-tz. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||98.027|75.735|
73850845|NCT01763333|147248727|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean ratio|74.42|||||TWO_SIDED|90.0|65.979|83.941|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||83.941|65.979|
73850846|NCT01763333|147248727|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.2|||||TWO_SIDED|90.0|119.611|157.374|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of R2 vs R1(PPS-BA-R2-R1) was used.||157.374|119.611|
73850847|NCT01763333|147248727|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.83|||||TWO_SIDED|90.0|111.814|122.079|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||122.079|111.814|
73850848|NCT02227810|147248732|OTHER|||||||0.652|||||||t-test, 2 sided|||||||0.652
73850849|NCT02227810|147248732|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
73850850|NCT02227810|147248733|SUPERIORITY|||||||0.051|||||||t-test, 2 sided|||||||0.051
73850851|NCT02227810|147248733|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73850852|NCT02227810|147248734|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 2 sided|||||||0.051
73850853|NCT02227810|147248735|SUPERIORITY_OR_OTHER|||||||0.792|||||||t-test, 2 sided|||||||0.792
73850854|NCT03063606|147248739|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.0002|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session.||||||.0002
73850855|NCT03063606|147248740|SUPERIORITY|||||||0.83||||||Analyses used all available data. Analyses to compare treatments were all intent-to-treat.|Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session.||||||.83
73850856|NCT03079531|147248749|OTHER|||||||0.01|||||||Wilcoxon signed rank test|||The null hypothesis is that there would be no difference in papule/pustule count at baseline and after 16 weeks of secukinumab; the alternative hypothesis is that there would be a difference. Using an alpha=0.05 and power=0.80 (two sided test), the sample size needed would be 20. Assuming a dropout rate of 20%, 24 patients would be needed to achieve sufficient sample size.||||0.01
73850857|NCT03079531|147248750|OTHER|||||||0.02|||||||Wilcoxon signed rank test|||||||0.02
73850858|NCT03079531|147248751|OTHER|||||||0.03|||||||Wilcoxon signed rank test|||||||0.03
73850859|NCT03079531|147248752|OTHER|||||||0.2|||||||Wilcoxon signed rank test|||||||0.2
73850860|NCT03079531|147248753|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
73850861|NCT03079531|147248755|OTHER|||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
73850862|NCT01198574|147248761|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GLM for repeated measures|The Hb concentration at Week 0, Week 6 and Week 12 are analyzed using GLM repeated measures.||"Null Hypothesis~1. Haemoglobin level was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve the haemoglobin level of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
73850863|NCT01198574|147248762|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||GLM for repeated measures ANOVA|||"Null hypothesis~1. Iron status indicator (serum ferritin) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve the iron status indicator (serum ferritin) concentration of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
73850864|NCT01198574|147248763|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||GLM for repeated measures ANOVA|||"Null Hypothesis~1. iron status indicator (sTfR) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve iron status indicator (sTfR) of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
73961808|NCT01149369|147460162|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.0||||0.48|TWO_SIDED|95.0|-3.6|7.6|||ANCOVA|||||7.6|-3.6|0.48
73961809|NCT01149369|147460163|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.5||||0.43|TWO_SIDED|95.0|-2.2|5.1|||ANCOVA|||||5.1|-2.2|0.43
73961810|NCT01149369|147460164|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.8||||0.01|TWO_SIDED|95.0|-8.5|-1.2|||ANCOVA|||||-1.2|-8.5|0.01
74024263|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9788|TWO_SIDED|95.0|-0.19|0.19|||t-test, 2 sided|||Differences in item 13 between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.19|-0.19|0.9788
73961811|NCT01149369|147460165|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.4||||0.57|TWO_SIDED|95.0|-3.4|6.1|||ANCOVA|||||6.1|-3.4|0.57
73961812|NCT01149369|147460166|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.84||||0.34|TWO_SIDED|95.0|-2.6|1.0|||ANCOVA|||||1.0|-2.6|0.34
73961813|NCT01599793|147460213|EQUIVALENCE|Testing if the change of ktrans between 2 weeks and baseline = 0 (i.e testing if the difference of means between 2 weeks and baseline =0)||||||0.0016|||||||Mixed Models Analysis|||The least square means of ktrans at different time points (baseline, 2 weeks, 12 weeks, 24 weeks) are estimated by a linear mixed model. Comparison of means at different time points were performed. The primary result reported below is for the difference of means between 2 weeks and baseline.||||0.0016
74024264|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.2747|TWO_SIDED|95.0|-0.33|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.09|-0.33|0.2747
74024265|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.2776|TWO_SIDED|95.0|-0.5|0.14|||t-test, 2 sided|||Differences in item 13 between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.14|-0.50|0.2776
73961814|NCT01599793|147460215|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the bone scan response change. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.36853||||0.3291|TWO_SIDED||||||t-test, 2 sided|||||||0.3291
74024266|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.1403|TWO_SIDED|95.0|-0.62|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||0.09|-0.62|0.1403
74024267|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.9151|TWO_SIDED|95.0|-0.55|0.5|||t-test, 2 sided|||Differences in item 13 between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||0.50|-0.55|0.9151
73961815|NCT01599793|147460217|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the PSA change. We tested if the coefficient = 0|Spearman Correlation Coefficients|-0.41818||||0.2006|TWO_SIDED||||||t-test, 2 sided|||||||0.2006
73961816|NCT01599793|147460219|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the Change in pain scale. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.17669||||0.5828|TWO_SIDED||||||t-test, 2 sided|||||||0.5828
74024268|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.3277|TWO_SIDED|95.0|-0.36|1.05|||t-test, 2 sided|||Differences in item 13 between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.05|-0.36|0.3277
74024269|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.86|0.86|||t-test, 2 sided|||Differences in item 13 between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||0.86|-0.86|1.0000
74024270|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57||||0.5661|TWO_SIDED|95.0|-1.53|2.67|||t-test, 2 sided|||Differences in item 13 between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||2.67|-1.53|0.5661
74024271|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.7309|TWO_SIDED|95.0|-2.95|2.15|||t-test, 2 sided|||Differences in item 13 between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||2.15|-2.95|0.7309
74024272|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.25||||0.3273|TWO_SIDED|95.0|-2.16|4.66|||t-test, 2 sided|||Differences in item 13 between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||4.66|-2.16|0.3273
74024273|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in item 13 between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
73901562|NCT03875235|147333340|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.021|TWO_SIDED|97.0|0.64|0.99||The analysis was performed using a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.03 significance level.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.|The 2-sided significance level for OS at the second interim analysis was 3%.|95% CI 0.66 to 0.97|0.99|0.64|0.021
73961817|NCT02918279|147460255|SUPERIORITY||Treatment difference|-0.22||||0.0022|TWO_SIDED|95.0|-0.37|-0.08|||ANCOVA||Liraglutide 3.0 mg - Placebo|Analysis of in-trial data with missing observations was imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Responses at week 56 were analysed using an analysis of covariance model with treatment, sex, region, baseline glycaemic category, stratification factor for Tanner stage and interaction between baseline glycaemic category and stratification factor for Tanner stage as fixed effects, baseline BMI SDS, age as covariates.||-0.08|-0.37|0.0022
74024274|NCT00609622|147600709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.7108|TWO_SIDED|95.0|-0.39|0.27|||t-test, 2 sided|||Differences in item 13 between treatment arms (EOT) was analyzed from a two-sample t-test.||0.27|-0.39|0.7108
74024275|NCT02370121|147600710|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
74024276|NCT02370121|147600711|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
74024277|NCT02370121|147600712|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
74024278|NCT02370121|147600713|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
74024279|NCT02370121|147600714|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
74024280|NCT02370121|147600715|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
74024281|NCT02370121|147600716|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
74024282|NCT02370121|147600717|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
74024283|NCT02370121|147600718|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
74024284|NCT02370121|147600719|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
74024285|NCT02370121|147600720|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
74024286|NCT02370121|147600721|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
74024287|NCT02370121|147600722|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
74024288|NCT02370121|147600723|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
74024289|NCT02370121|147600724|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
74024290|NCT02370121|147600725|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
74024291|NCT02370121|147600726|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
74024292|NCT05198713|147600728|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73850865|NCT00556439|147248775|OTHER|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.049||||||The p value of 0.049 reflects comparison of relapse free survival of abatacept versus placebo in giant cell arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||0.049
73850866|NCT00556439|147248775|OTHER|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.853||||||The p value of 0.853 reflects comparison of relapse free survival of abatacept versus placebo in Takayasu arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||0.853
73850867|NCT00325130|147248799|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
73850868|NCT00325130|147248801|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
73850869|NCT00325130|147248802|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
73850870|NCT00325130|147248803|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
73850871|NCT00325130|147248804|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
73850872|NCT00325130|147248805|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
73850873|NCT00325130|147248806|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
73850874|NCT00325130|147248807|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
73850875|NCT00325130|147248808|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
73901563|NCT03875235|147333343|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.001|TWO_SIDED|95.19|0.63|0.89||The p-value is based on a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.0481 significance level.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.|The 2-sided significance level for PFS at the second interim analysis was 4.81%.|95% CI 0.63 to 0.89|0.89|0.63|0.001
73901564|NCT03875235|147333346|SUPERIORITY||Odds Ratio (OR)|1.6||||0.011|TWO_SIDED|95.0|1.11|2.31|||Cochran-Mantel-Haenszel||OR and CI were estimated from a stratified CMH test adjusting for disease status and primary tumor location.|||2.31|1.11|0.011
73850876|NCT00325130|147248809|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
73850877|NCT00325130|147248810|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73901565|NCT04526665|147333356|OTHER||Odds Ratio (OR)|37.562|||<|0.0001|TWO_SIDED|95.0|7.641|302.247|||Exact Cochran-Mantel-Haenszel test|Exact Cochran-Mantel-Haenszel test stratified by the randomization factors (ALP \>3xULN or TB\>ULN:Yes/No, and Baseline PBC Worst Itch NRS ≥ 4: Yes/No)||||302.247|7.641|<0.0001
73901566|NCT04526665|147333358|OTHER||Least square mean difference|-0.784||||0.197|TWO_SIDED|95.0|-1.986|0.418|||mixed model for repeated measures (MMRM)|||||0.418|-1.986|0.1970
73901567|NCT04526665|147333359|OTHER||Least square mean difference|-0.343||||0.5522|TWO_SIDED|95.0|-1.489|0.803|||MMRM|MMRM with treatment, 4-week period and treatment by 4-week period interaction as fixed factors and adjusting for baseline and stratification factors.||||0.803|-1.489|0.5522
73850878|NCT00325130|147248811|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73850879|NCT00325130|147248812|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73850880|NCT00325130|147248813|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73850881|NCT00325130|147248814|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73850882|NCT00325130|147248815|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73850883|NCT00325130|147248816|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73850884|NCT00325130|147248817|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73850885|NCT03159468|147248825|OTHER|||||||0.041||||||This p-value is for the main effect of beverage condition.|ANOVA|||||||.041
73850886|NCT03159468|147248825|OTHER|||||||0.16||||||This p-value is for the main effect of intervention condition.|ANOVA|||||||.160
73850887|NCT03159468|147248825|OTHER|||||||0.462||||||This p-value is for the beverage condition by intervention condition interaction.|ANOVA|||||||.462
73850888|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.28|0.56|||||Confidence Intervals (CI) for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 minus \[-\] Vax 1).|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.56|0.28|
73850889|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.01|0.67|
73850890|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.44|0.72|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 4: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.72|0.44|
73850891|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.53|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 5: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.53|0.32|
74024301|NCT05818124|147600789|OTHER||Difference in Least Squares Mean|-0.48||||0.783|TWO_SIDED|95.0|-3.97|3.0|||ANOVA|||||3.00|-3.97|0.783
74024302|NCT05818124|147600790|OTHER||Difference in Least Squares Mean|-2.21||||0.032|TWO_SIDED|95.0|-4.21|-0.21|||ANOVA|||||-0.21|-4.21|0.032
74024303|NCT05818124|147600791|OTHER||Difference in Least Squares Mean|0.2||||0.756|TWO_SIDED|95.0|-1.07|1.47|||ANOVA|||||1.47|-1.07|0.756
73850892|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.45|0.91|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.91|0.45|
73850893|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.56|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6B: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.01|0.56|
73850894|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.25|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 7F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.65|0.25|
73850895|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.16|0.4|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 9V: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.40|0.16|
73850896|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.4|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 14: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.78|0.40|
73850897|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 18C: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.65|0.40|
73850898|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.3|0.48|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.48|0.30|
73850899|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.35|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.67|0.35|
73850900|NCT00500357|147248838|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||TWO_SIDED|95.0|0.86|1.86|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 23F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.86|0.86|
73850901|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.57|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.57|0.34|
73850902|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|0.95|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.95|0.66|
73850903|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.76|1.22|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.22|0.76|
74024304|NCT05818124|147600792|OTHER|Clopper and Pearson exact binomial method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-23.21|23.21||||||||23.21|-23.21|
74024305|NCT05818124|147600793|OTHER|Clopper and Pearson binomial method|Difference in percentage|-2.86|||||TWO_SIDED|95.0|-25.78|20.27||||||||20.27|-25.78|
74024306|NCT05818124|147600794|OTHER|Clopper and Pearson exact binomial method|Difference in Percentage|-8.57|||||TWO_SIDED|95.0|-30.26|13.38||||||||13.38|-30.26|
73850904|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.8|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.80|0.57|
73850905|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|2.0|||||TWO_SIDED|95.0|1.39|2.84|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||2.84|1.39|
73850906|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.11|1.63|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.63|1.11|
73850907|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.18|0.41|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.41|0.18|
73850908|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.27|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.68|0.27|
73850909|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.83|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.83|0.57|
73850910|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|1.03|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.03|0.66|
73850911|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.78|0.58|
73850912|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.47|0.73|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.73|0.47|
73850913|NCT00500357|147248841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.18|1.94|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.94|1.18|
73850914|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.65|||||TWO_SIDED|95.0|0.52|0.82|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.82|0.52|
73850915|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.52|||||TWO_SIDED|95.0|0.43|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.62|0.43|
73850916|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.63|||||TWO_SIDED|95.0|0.53|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.76|0.53|
73850917|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.32|||||TWO_SIDED|95.0|0.27|0.39|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.39|0.27|
73850918|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.74|1.1|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.10|0.74|
74024307|NCT05818124|147600795|OTHER|Clopper and Pearson binomial method|Difference in percentage|-5.71|||||TWO_SIDED|95.0|-25.18|13.97||||||||13.97|-25.18|
74024308|NCT05818124|147600796|OTHER|Clopper and Pearson binomial method|Difference in percentage|-5.71|||||TWO_SIDED|95.0|-25.18|13.97||||||||13.97|-25.18|
74024309|NCT05818124|147600797|OTHER|Clopper and Pearson binomial method|Difference in percentage|-8.57|||||TWO_SIDED|95.0|-27.63|10.5||||||||10.50|-27.63|
74024310|NCT05818124|147600800|OTHER||Hazard Ratio (HR)|0.82||||0.3102|TWO_SIDED|95.0|0.51|1.33|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.33|0.51|0.3102
74024311|NCT05818124|147600801|OTHER||Hazard Ratio (HR)|0.55||||0.0779|TWO_SIDED|95.0|0.27|1.14|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.14|0.27|0.0779
74024312|NCT05818124|147600804|OTHER||Difference in Least Squares Mean|-3.79||||0.045|TWO_SIDED|95.0|-7.47|-0.1|||ANOVA|||||-0.10|-7.47|0.045
73850919|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.79|||||TWO_SIDED|95.0|0.63|0.99|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.99|0.63|
73850920|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.72|||||TWO_SIDED|95.0|0.6|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.87|0.60|
73850921|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.6|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.60|0.42|
73850922|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.76|||||TWO_SIDED|95.0|0.59|0.98|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.98|0.59|
73850923|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.38|||||TWO_SIDED|95.0|0.31|0.46|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.46|0.31|
73850924|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.74|0.49|
73850925|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.64|||||TWO_SIDED|95.0|0.52|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.79|0.52|
73850926|NCT00500357|147248842|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.76|||||TWO_SIDED|95.0|0.62|0.93|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.93|0.62|
73850927|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.6|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.78|0.60|
73850928|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.55|||||TWO_SIDED|95.0|0.48|0.64|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.64|0.48|
73850929|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.75|||||TWO_SIDED|95.0|0.65|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.87|0.65|
73850930|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.61|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.76|0.61|
73850931|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.49|||||TWO_SIDED|95.0|1.27|1.75|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.75|1.27|
73850932|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.07|||||TWO_SIDED|95.0|0.94|1.21|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.21|0.94|
73850933|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.58|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.79|0.58|
73850934|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.68|0.53|
74024313|NCT05818124|147600805|OTHER||Difference in Least Squares Mean|-2.56||||0.226|TWO_SIDED|95.0|-6.81|1.69|||ANOVA|||||1.69|-6.81|0.226
73850935|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.59|||||TWO_SIDED|95.0|0.51|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.67|0.51|
74024314|NCT05818124|147600806|OTHER||Difference in Least Squares Mean|-1.6||||0.09|TWO_SIDED|95.0|-3.47|0.27|||ANOVA|||||0.27|-3.47|0.090
74024315|NCT05818124|147600807|OTHER||Difference in Least Squares Mean|0.74||||0.609|TWO_SIDED|95.0|-2.19|3.66|||ANOVA|||||3.66|-2.19|0.609
74024316|NCT05818124|147600808|OTHER|Difference in Least Squares Mean|Difference in Least Squares Mean|0.34||||0.614|TWO_SIDED|95.0|-1.04|1.72|||ANOVA|||||1.72|-1.04|0.614
74024317|NCT05818124|147600809|OTHER||Difference in Least Squares Mean|0.37||||0.608|TWO_SIDED|95.0|-1.09|1.83|||ANOVA|||||1.83|-1.09|0.608
74024318|NCT05818124|147600810|OTHER||Difference in Least Squares Mean|0.43||||0.288|TWO_SIDED|95.0|-0.39|1.25|||ANOVA|||||1.25|-0.39|0.288
74024319|NCT05818124|147600811|OTHER||Difference in Least Squares Mean|0.09||||0.842|TWO_SIDED|95.0|-0.8|0.97|||ANOVA|||||0.97|-0.80|0.842
73850936|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.67|||||TWO_SIDED|95.0|0.6|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.74|0.60|
73850937|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.78|||||TWO_SIDED|95.0|0.69|0.88|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.88|0.69|
73850938|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.54|||||TWO_SIDED|95.0|0.47|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.62|0.47|
73850939|NCT00500357|147248843|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.06|||||TWO_SIDED|95.0|0.9|1.25|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.25|0.90|
73850940|NCT00161616|147248844|SUPERIORITY_OR_OTHER|||||||0.0541|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 13.||||0.0541
73850941|NCT00161616|147248844|SUPERIORITY_OR_OTHER|||||||0.7983|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 20.||||0.7983
73850942|NCT00161616|147248845|SUPERIORITY_OR_OTHER|||||||0.8961|||||||Fisher Exact|||||||0.8961
73850943|NCT03782259|147248888|SUPERIORITY||||||<|0.0125||||||Given that there were 4 separate comparisons of the primary outcomes, the level of significance was adjusted from 0.05 to 0.0125 (.05/4) using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|There were no adjustments for covariates.||||||< 0 .0125
73850944|NCT03782259|147248889|SUPERIORITY||||||<|0.0125||||||Given that there were 4 separate comparisons of the primary outcomes, the level of significance was adjusted from 0.05 to 0.0125 (.05/4) using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|There were no adjustments for covariates.||||||< 0 .0125
73850945|NCT01709110|147248906|SUPERIORITY||Odds Ratio (OR)|0.4071||||9.4e-05|TWO_SIDED|95.0|0.256|0.647|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.647|0.256|0.000094
73850946|NCT01709110|147248906|SUPERIORITY||Risk Ratio (RR)|0.4431||||9.4e-05|TWO_SIDED|95.0|0.29|0.677|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.677|0.290|0.000094
73850947|NCT01709110|147248907|SUPERIORITY||Odds Ratio (OR)|0.4187||||7.5e-05|TWO_SIDED|95.0|0.269|0.652|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.652|0.269|0.000075
73850948|NCT01709110|147248907|SUPERIORITY||Risk Ratio (RR)|0.4561||||7.5e-05|TWO_SIDED|95.0|0.305|0.682|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.682|0.305|0.000075
73850949|NCT01709110|147248908|SUPERIORITY||Stratified Hazard Ratio (HR)|0.4831||||0.000869|TWO_SIDED|95.0|0.316|0.739|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||0.739|0.316|0.000869
73850950|NCT01709110|147248909|SUPERIORITY||Stratified Hazard Ratio (HR)|0.6553||||0.099023|TWO_SIDED|95.0|0.39|1.101|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.101|0.390|0.099023
73850951|NCT01709110|147248910|SUPERIORITY||Stratified Hazard Ratio (HR)|0.5786||||0.062432|TWO_SIDED|95.0|0.318|1.052|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.052|0.318|0.062432
73850952|NCT01709110|147248911|SUPERIORITY||Odds Ratio (OR)|0.3812|||<|0.001|TWO_SIDED|95.0|0.237|0.614|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.614|0.237|<0.001
73850953|NCT01709110|147248911|SUPERIORITY||Risk Ratio (RR)|0.4173|||<|0.001|TWO_SIDED|95.0|0.27|0.646|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.646|0.270|<0.001
73850954|NCT01709110|147248912|SUPERIORITY||Odds Ratio (OR)|0.1593||||0.007|TWO_SIDED|95.0|0.035|0.728|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.728|0.035|0.007
73850955|NCT01709110|147248912|SUPERIORITY||Risk Ratio (RR)|0.1643||||0.007|TWO_SIDED|95.0|0.036|0.744|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.744|0.036|0.007
73850956|NCT01709110|147248913|SUPERIORITY||Stratified Hazard Ratio (HR)|0.696||||0.078|TWO_SIDED|95.0|0.461|1.05|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimates and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.050|0.461|0.078
73850957|NCT01709110|147248914|SUPERIORITY||Least Squares Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.093|TWO_SIDED|95.0|-0.28|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline body height(cm).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.02|-0.28|0.093
73850958|NCT01709110|147248915|SUPERIORITY||Least Squares Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.585|TWO_SIDED|95.0|-0.42|0.24||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline back pain (no pain - worst pain \[0-10\]).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.24|-0.42|0.585
73850959|NCT01709110|147248916|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.757|TWO_SIDED|95.0|-0.03|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (UK).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.02|-0.03|0.757
73850960|NCT01709110|147248917|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.694|TWO_SIDED|95.0|-0.02|0.01||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (US).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.01|-0.02|0.694
73850961|NCT03332173|147248921|SUPERIORITY||||||<|0.0001||||||P value was based on the exact binomial test against the null hypothesis H0: MRR = 0.30 at a significance level of 0.025 (1-sided)|Exact binomial test|||Zanubrutinib versus historical control estimate of 30%||||<0.0001
73850962|NCT05507567|147248936|OTHER|||||||0.0331|||||||Chi-squared|||A priori primary analysis group||||0.0331
73850963|NCT05507567|147248937|OTHER|||||||0.1427||||||Hodges-Lehmann (H-L) estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.1427
73850964|NCT05507567|147248938|OTHER|||||||0.1307||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.1307
73850965|NCT05507567|147248939|OTHER|||||||0.0382||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.0382
73850966|NCT05507567|147248940|OTHER|||||||0.011||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.0110
73850967|NCT00910910|147248945|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.323|TWO_SIDED|90.0|0.88|1.66|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to \< 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )\> 4.0 mg/L (Yes versus No VS Unknown)||1.66|0.88|0.323
73850968|NCT00910910|147248946|SUPERIORITY||Cox Proportional Hazard|0.99||||0.967|TWO_SIDED|90.0|0.76|1.29||The p-value is based on a stratified log-rank test|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to \< 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )\> 4.0 mg/L (Yes versus No VS Unknown)||1.29|0.76|0.967
73850969|NCT00910910|147248949|SUPERIORITY||Odds Ratio (OR)|0.65||||0.032|TWO_SIDED|95.0|0.44|0.96|||Fisher Exact|||||0.96|0.44|0.032
73850970|NCT00910910|147248950|SUPERIORITY||Odds Ratio (OR)|0.66||||0.047|TWO_SIDED|95.0|0.45|0.98|||Fisher Exact|||||0.98|0.45|0.047
73850971|NCT00910910|147248951|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.826|TWO_SIDED|90.0|0.58|1.52|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.52|0.58|0.826
73850972|NCT00910910|147248952|SUPERIORITY||Cox Proportional Hazard|0.71||||0.149|TWO_SIDED|90.0|0.48|1.05|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.05|0.48|0.149
74024320|NCT05818124|147600814|OTHER||Hazard Ratio (HR)|0.31||||0.0042|TWO_SIDED|95.0|0.14|0.71|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||0.71|0.14|0.0042
74024321|NCT05818124|147600815|OTHER||Hazard Ratio (HR)|0.69||||0.329|TWO_SIDED|95.0|0.33|1.46|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.46|0.33|0.3290
74088263|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|2.73||0.8204|TWO_SIDED|95.0|-6.03|4.79|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.79|-6.03|0.8204
73850973|NCT00910910|147248955|SUPERIORITY||Cox Proportional Hazard|1.03||||0.883|TWO_SIDED|90.0|0.73|1.46|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.46|0.73|0.883
73850974|NCT00910910|147248956|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.06||||0.709|TWO_SIDED|90.0|0.83|1.34|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.34|0.83|0.709
73850975|NCT03024112|147248968|OTHER|||||||0.68|||||||t-test, 1 sided|||||||0.680
73850976|NCT01277822|147248982|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin was 3 mmHg as Korean Food and Drug Administration (KFDA) guidance.|Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|7.7||0.1339|TWO_SIDED|95.0|-3.0|0.4|||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis||||0.4|-3.0|0.1339
73850977|NCT01277822|147248983|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4478||||||No imputation for missing data was performed|t-test, 2 sided|||||||0.4478
73850978|NCT01277822|147248984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0717|||||||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis||||||0.0717
73850979|NCT01277822|147248985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8736|||||||t-test, 2 sided|No imputation for missing data was performed||||||0.8736
73850980|NCT01277822|147248986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2508||||||No imputation for missing data was performed|Chi-squared|||||||0.2508
73850981|NCT01277822|147248987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2508||||||No imputation for missing data was performed|Chi-squared|||||||0.2508
73850982|NCT01277822|147248988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6646|||||||Chi-squared|||||||0.6646
73850983|NCT01277822|147248989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7911||||||Left ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided|||||||0.7911
73850984|NCT01277822|147248989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5933||||||Right ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided|||||||0.5933
73850985|NCT00997984|147249001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
73850986|NCT00997984|147249001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
73850987|NCT00997984|147249001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
73850988|NCT00997984|147249002|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
73850989|NCT00997984|147249002|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
73850990|NCT00997984|147249002|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
73850991|NCT00997984|147249003|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
73850992|NCT00997984|147249003|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
73850993|NCT00997984|147249003|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
73850994|NCT00997984|147249004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.099||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.099
73850995|NCT00997984|147249004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.596||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.596
73850996|NCT00997984|147249004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.023
74024322|NCT05818124|147600816|OTHER||Hazard Ratio (HR)|0.6||||0.1502|TWO_SIDED|95.0|0.27|1.34|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.34|0.27|0.1502
74024323|NCT05818124|147600817|OTHER||Hazard Ratio (HR)|1.32||||0.4865|TWO_SIDED|95.0|0.59|2.92|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.92|0.59|0.4865
74024324|NCT05818124|147600820|OTHER||Difference in Least Squares Mean|-4.79||||0.313|TWO_SIDED|95.0|-14.36|4.78|||ANOVA|||||4.78|-14.36|0.313
74024325|NCT05818124|147600821|OTHER||Difference in Least Squares Mean|-6.87||||0.138|TWO_SIDED|95.0|-16.11|2.36|||ANOVA|||||2.36|-16.11|0.138
73850997|NCT00997984|147249006|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
73850998|NCT00997984|147249006|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
73850999|NCT00997984|147249006|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
73851000|NCT00997984|147249007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.712||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.712
73851001|NCT00997984|147249007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.531||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.531
73851002|NCT00997984|147249007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.226
73851003|NCT00997984|147249008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.859||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.859
73961818|NCT01641198|147460335|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.115|<|0.05|TWO_SIDED|95.0|-0.59|0.01||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.01|-0.59|<0.05
74024326|NCT05818124|147600822|OTHER||Difference in LS mean|0.74||||0.706|TWO_SIDED|95.0|-3.26|4.74|||ANOVA|||||4.74|-3.26|0.706
74024327|NCT05818124|147600823|OTHER||Difference in LS mean|-1.58||||0.367|TWO_SIDED|95.0|-5.1|1.95|||ANOVA|||||1.95|-5.10|0.367
73851004|NCT00997984|147249008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.527
73851005|NCT00997984|147249008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.739
73851006|NCT00997984|147249009|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
73851007|NCT00997984|147249009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.004
73851008|NCT00997984|147249009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.001
73851009|NCT02110485|147249045|SUPERIORITY|||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
73851010|NCT02110485|147249046|OTHER|||||||0.27|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.27
73851011|NCT02110485|147249047|OTHER|||||||0.67|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.67
73851012|NCT02110485|147249048|OTHER|||||||0.17|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.17
73851013|NCT02110485|147249049|OTHER|||||||0.84|||||||Fisher Exact|||||||.84
73851014|NCT02110485|147249050|OTHER|||||||0.99|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.99
73851015|NCT00418093|147249063|SUPERIORITY_OR_OTHER||Proportion|0.684|||||TWO_SIDED|95.0|0.43|0.87||Exact 95% CI for the partial response rate (13/19 = 0.684): 43.4% \~ 87.4%|Estimation of PR based on Binomial Model|We did not perform a test. Point estimate of PR and its exact 95% CI based on Binomial Model is provided. Thus there is no p-value to report.|Point estimate of PR and its exact 95% CI based on Binomial Model|||0.87|0.43|
73851016|NCT00418093|147249063|SUPERIORITY_OR_OTHER||Single Proportion|0.684|||||TWO_SIDED|95.0|0.434|0.874||We did not perform hypothesis test. We made an estimation for a single proportion (partial response) with its two-sided 95% exact Binomial confidence interval.|Fisher Exact||Estimation of a single proportion (partial response rate) with exact 95% Binomial confidence interval|||0.874|0.434|
73851017|NCT03162796|147249072|SUPERIORITY||Difference in percentage|29.8|||<|0.001|TWO_SIDED|95.0|18.6|41.1|||Cochran-Mantel-Haenszel|||||41.1|18.6|< 0.001
74024328|NCT05818124|147600829|OTHER||Difference in LS Mean|-4.14||||0.177|TWO_SIDED|95.0|-10.2|1.92|||ANOVA|||||1.92|-10.20|0.177
74024329|NCT05818124|147600830|OTHER||Difference in LS mean|-0.97||||0.395|TWO_SIDED|95.0|-3.24|1.29|||ANOVA|||||1.29|-3.24|0.395
74024330|NCT05818124|147600842|OTHER|Difference in least squares mean|Difference in least squares means|-0.94||||0.11|TWO_SIDED|95.0|-2.1|0.22|||ANOVA|||||0.22|-2.10|0.110
74024331|NCT05818124|147600843|OTHER||Difference in least squares mean|-1.6||||0.09|TWO_SIDED|95.0|-3.47|0.27|||ANOVA|||||0.27|-3.47|0.090
74024332|NCT01232946|147600872|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
74024333|NCT01232946|147600873|SUPERIORITY|||||||0.065|||||||Kruskal-Wallis|||||||0.065
74024334|NCT01232946|147600874|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||||||0.80
74024335|NCT00733902|147600897|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.3||0.015|TWO_SIDED|95.0|-1.32|-0.14|||ANCOVA|||Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-1.32|0.015
74024336|NCT00733902|147600897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|-1.43|-0.25|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.25|-1.43|0.005
74024337|NCT00733902|147600897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.78|-0.61|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.61|-1.78|<0.001
74024338|NCT00733902|147600898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.29||0.009|TWO_SIDED|95.0|-1.32|-0.19|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-1.32|0.009
74024339|NCT00733902|147600898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.54|-0.41|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.54|<0.001
73851018|NCT03162796|147249072|SUPERIORITY||Difference in percentage|37.1|||<|0.001|TWO_SIDED|95.0|26.1|48.2|||Cochran-Mantel-Haenszel|||||48.2|26.1|< 0.001
73851019|NCT03162796|147249073|SUPERIORITY||Least Square (LS) Mean Difference|-0.2483|||<|0.001|TWO_SIDED|95.0|-0.364|-0.1325|||ANCOVA|||||-0.1325|-0.3640|< 0.001
73851020|NCT03162796|147249073|SUPERIORITY||LS Mean difference|-0.3226|||<|0.001|TWO_SIDED|95.0|-0.4385|-0.2066|||ANCOVA|||||-0.2066|-0.4385|< 0.001
73851021|NCT03162796|147249074|SUPERIORITY||Difference in percentage|21.4|||<|0.001|TWO_SIDED|95.0|12.1|30.7||Nominal|Cochran-Mantel-Haenszel|||||30.7|12.1|< 0.001
73851022|NCT03162796|147249074|SUPERIORITY||Difference in percentage|27.2|||<|0.001|TWO_SIDED|95.0|17.6|36.8||Nominal|Cochran-Mantel-Haenszel|||||36.8|17.6|< 0.001
73851023|NCT03162796|147249075|SUPERIORITY||Difference in percentage|42.0|||<|0.001|TWO_SIDED|95.0|28.9|55.1|||Cochran-Mantel-Haenszel|||||55.1|28.9|< 0.001
73851024|NCT03162796|147249075|SUPERIORITY||Difference in percentage|60.0|||<|0.001|TWO_SIDED|95.0|48.3|71.8|||Cochran-Mantel-Haenszel|||||71.8|48.3|< 0.001
73851025|NCT03162796|147249076|SUPERIORITY||Difference in percentage|26.7|||<|0.001|TWO_SIDED|95.0|15.3|38.1||Nominal|Cochran-Mantel-Haenszel|||||38.1|15.3|< 0.001
73851026|NCT03162796|147249076|SUPERIORITY||Difference in percentage|34.8|||<|0.001|TWO_SIDED|95.0|23.5|46.0||Nominal|Cochran-Mantel-Haenszel|||||46.0|23.5|< 0.001
73851027|NCT03162796|147249077|SUPERIORITY||LS Mean difference|-0.73|||<|0.001||95.0|-0.98|-0.48||Nominal|ANCOVA|||||-0.48|-0.98|< 0.001
73851028|NCT03162796|147249077|SUPERIORITY||LS Mean difference|-0.91|||<|0.001||95.0|-1.16|-0.66||Nominal|ANCOVA|||||-0.66|-1.16|< 0.001
73851029|NCT03162796|147249078|SUPERIORITY||Difference in percentage|6.4||||0.069|TWO_SIDED|95.0|-0.3|13.1|||Cochran-Mantel-Haenszel|||||13.1|-0.3|0.069
73851030|NCT03162796|147249078|SUPERIORITY||Difference in percentage|14.8|||<|0.001|TWO_SIDED|95.0|6.9|22.7|||Cochran-Mantel-Haenszel|||||22.7|6.9|< 0.001
73851031|NCT03162796|147249079|SUPERIORITY||Difference in percentage|10.2||||0.036|TWO_SIDED|95.0|1.0|19.3||Nominal|Cochran-Mantel-Haenszel|||||19.3|1.0|0.036
73851032|NCT03162796|147249079|SUPERIORITY||Difference in percentage|13.9||||0.006|TWO_SIDED|95.0|4.4|23.4||Nominal|Cochran-Mantel-Haenszel|||||23.4|4.4|0.006
73851033|NCT03162796|147249080|SUPERIORITY||LS Mean difference|4.14|||<|0.001|TWO_SIDED|95.0|2.42|5.85|||ANCOVA|||||5.85|2.42|< 0.001
73851034|NCT03162796|147249080|SUPERIORITY||LS Mean difference|4.91|||<|0.001||95.0|3.19|6.63|||ANCOVA|||||6.63|3.19|< 0.001
73851035|NCT03162796|147249081|SUPERIORITY||Difference in percentage|13.0||||0.094|TWO_SIDED|95.0|-1.6|27.5||Nominal|Cochran-Mantel-Haenszel|||||27.5|-1.6|0.094
73851036|NCT03162796|147249081|SUPERIORITY||Difference in percentage|19.8||||0.013|TWO_SIDED|95.0|4.9|34.6||Nominal|Cochran-Mantel-Haenszel|||||34.6|4.9|0.013
73851037|NCT03162796|147249082|SUPERIORITY||LS Mean difference|-0.33||||0.185|TWO_SIDED|95.0|-0.83|0.16||Nominal|ANCOVA|||||0.16|-0.83|0.185
74024340|NCT00733902|147600898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.8|-0.68|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.68|-1.80|<0.001
74024341|NCT00733902|147600899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.52|-0.13|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.13|-0.52|0.001
74024342|NCT00733902|147600899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.56|-0.17|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.56|<0.001
73851038|NCT03162796|147249082|SUPERIORITY||LS Mean difference|-0.74||||0.004|TWO_SIDED|95.0|-1.24|-0.24||Nominal|ANCOVA|||||-0.24|-1.24|0.004
73851039|NCT03162796|147249083|SUPERIORITY||LS Mean difference|0.83||||0.398|TWO_SIDED|95.0|-1.1|2.77||Nominal|ANCOVA|||||2.77|-1.10|0.398
73851040|NCT03162796|147249083|SUPERIORITY||LS Mean difference|1.23||||0.214|TWO_SIDED|95.0|-0.71|3.16||Nominal|ANCOVA|||||3.16|-0.71|0.214
73851041|NCT03162796|147249084|SUPERIORITY||Difference in percentage|16.6||||0.088|TWO_SIDED|95.0|-1.5|34.8||Nominal|Cochran-Mantel-Haenszel|||||34.8|-1.5|0.088
73851042|NCT03162796|147249084|SUPERIORITY||Difference in percentage|13.4||||0.212|TWO_SIDED|95.0|-6.9|33.7||Nominal|Cochran-Mantel-Haenszel|||||33.7|-6.9|0.212
73851043|NCT03162796|147249085|SUPERIORITY||LS Mean difference|-1.82||||0.121|TWO_SIDED|95.0|-4.12|0.49||Nominal|ANCOVA|||||0.49|-4.12|0.121
73851044|NCT03162796|147249085|SUPERIORITY||LS Mean difference|-1.53||||0.225|TWO_SIDED|95.0|-4.0|0.95||Nominal|ANCOVA|||||0.95|-4.00|0.225
73851045|NCT01181804|147249175|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|1.07|1.15|||ANOVA|||||1.15|1.07|
73851046|NCT01181804|147249176|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.43|||||TWO_SIDED|90.0|1.32|1.54|||ANOVA|||||1.54|1.32|
73851047|NCT01181804|147249177|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.1|||||TWO_SIDED|95.0|1.06|1.14|||ANOVA|||||1.14|1.06|
73851048|NCT01181804|147249178|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.15|||||TWO_SIDED|90.0|1.09|1.21|||ANOVA|||||1.21|1.09|
73851049|NCT03163134|147249183|OTHER|||||||0.017|||||||Chi-squared|||||||0.017
73851050|NCT03163134|147249184|OTHER|||||||0.577|||||||Chi-squared|||||||0.577
73851051|NCT03711370|147249188|OTHER|Repeated measures ANOVA was used to model between-subject effects of group (Clear versus Opaque), within-subjects effects of use of clear versus opaque bottles during the feeding observations, and potential group by bottle type interactions on infant intake during post-test feeding observations.||||||0.76||||||Statistical significance was defined as p \< 0.05.|Mixed Models Analysis|Models controlled for pre-test values, infant sex and age, time since last feeding, and whether the assessment was in-person or remote.||||||0.76
73851052|NCT03711370|147249189|OTHER|Repeated measures ANOVA was used to model between-subject effects of group (Clear versus Opaque), within-subjects effects of use of clear versus opaque bottles during the feeding observations, and potential group by-bottle type interactions on maternal sensitivity during post-test feeding observations.||||||0.64||||||Statistical significance was defined as p \< 0.05.|Mixed Models Analysis|Models controlled for pre-test values, infant sex and age, time since last feeding, and whether the assessment was in-person or remote.||||||0.64
73851053|NCT03711370|147249190|OTHER|General linear models were used to compare post-test weight-for-length z-scores (WLZ).||||||0.02||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|These models controlled for baseline values (i.e., baseline WLZ), infant sex and age, and whether the assessment was in-person or remote.||||||0.02
73851054|NCT03711370|147249191|OTHER|General linear models were used to compare post-test waist circumference for the Clear versus Opaque groups.||||||0.07||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|Model controlled for baseline values (i.e., waist circumference), infant sex and age, and whether the assessment was in-person or remote.||||||0.07
73851055|NCT03711370|147249192|OTHER|General linear models were used to compare post-test triceps skinfold z-scores for the Clear versus Opaque groups.||||||0.7||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|Model controlled for baseline values (i.e.,triceps skinfolds z-scores), infant sex and age, and whether the assessment was in-person or remote.||||||0.70
73851056|NCT02063984|147249203|SUPERIORITY||Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.11|1.56|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||1.56|.11|
73851057|NCT02063984|147249204|SUPERIORITY||Ratio of means|1.56|||||TWO_SIDED|95.0|0.79|3.07|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||3.07|.79|
73851058|NCT02063984|147249205|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.18|4.82||||||CM+No WMT is the comparison condition||4.82|.18|
73851059|NCT02063984|147249206|SUPERIORITY||Ratio of means|0.92|||||TWO_SIDED|95.0|0.33|2.54|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||2.54|.33|
73851060|NCT02063984|147249207|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.45|2.45||||||Strategy 1 is the comparison condition||2.45|.45|
73851061|NCT02063984|147249207|SUPERIORITY||Odds Ratio (OR)|2.29|||||TWO_SIDED|95.0|0.84|6.2||||||Strategy 1 is the comparison condition||6.20|.84|
73851062|NCT02063984|147249207|SUPERIORITY||Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.23|1.13||||||Strategy 1 is the comparison condition||1.13|.23|
73851063|NCT02063984|147249208|SUPERIORITY||Ratio of means|1.21|||||TWO_SIDED|95.0|0.76|1.92||||||Strategy 1 is the comparison condition||1.92|.76|
73851064|NCT02063984|147249208|SUPERIORITY||Ratio of means|0.76|||||TWO_SIDED|95.0|0.49|1.18||||||Strategy 1 is the comparison condition||1.18|.49|
73851065|NCT02063984|147249208|SUPERIORITY||Ratio of means|1.33|||||TWO_SIDED|95.0|0.83|2.15||||||Strategy 1 is the comparison condition||2.15|.83|
74024343|NCT00733902|147600899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.31|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.31|-0.70|<0.001
74024344|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.27||0.326|TWO_SIDED|95.0|-0.8|0.27|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.27|-0.80|0.326
74024345|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.275|TWO_SIDED|95.0|-0.24|0.83|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.83|-0.24|0.275
73851066|NCT00005947|147249227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.052||95.0|0.99|2.11|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable \[placebo/sipuleucel-T\].|||2.11|0.99|0.052
73851067|NCT00005947|147249227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.052|TWO_SIDED|95.0|0.47|1.01|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable \[sipuleucel-T/placebo\]|||1.01|0.47|0.052
73851068|NCT00005947|147249228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.71||||0.01||95.0|1.13|2.58|||Log Rank||Cox proportional hazards model with treatment as the independent variable \[placebo/sipuleucel-T\].|ITT Population - all randomized participants||2.58|1.13|0.010
73851069|NCT00005947|147249228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.586||||0.01|TWO_SIDED|95.0|0.388|0.884|||Log Rank||Cox proportional hazards model with treatment as the independent variable \[sipuleucel-T/placebo\]|ITT Population - all randomized participants.||0.884|0.388|0.010
73851070|NCT02195700|147249278|SUPERIORITY||LSM difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.0188|TWO_SIDED|95.0|-2.6|-0.2||5% level of significance (2-sided)|unstructured covariance|||The linear mixed model for repeated measurements (MMRM) included fixed effects for treatment, each scheduled time point (5 levels: weeks 2, 4, 6, 9, and 12), the treatment-by-time point interaction, and the DRA status. Baseline AIMS score was a covariate. The unstructured covariance model was used, and the primary analysis compared the SD-809 and placebo groups at week 12. This was based on the F-test using the Satterhwaite method to compute the denominator degrees of freedom.||-0.2|-2.6|0.0188
73851071|NCT02195700|147249279|SUPERIORITY||Differences in %|7.9||||0.4001|TWO_SIDED|95.0|-10.2|25.2||5% level of significance (2-sided)|Pearson's chi-square test|||The secondary efficacy endpoints were analyzed using a hierarchical testing procedure. If the primary analysis was statistically significant (p\<0.05), then the first key secondary endpoint was to be analyzed. If the first key secondary endpoint was statistically significant, then the second key secondary endpoint was to be similarly analyzed. For any analysis that was not statistically significant, all subsequent analyses of key secondary endpoints were exploratory rather than confirmatory.||25.2|-10.2|0.4001
73851072|NCT02931838|147249286|SUPERIORITY|||||||0.4873||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||0.4873
73851073|NCT02931838|147249286|SUPERIORITY|||||||0.0003||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||0.0003
73851074|NCT02931838|147249286|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||<0.0001
73851075|NCT02931838|147249286|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||< 0.0001
73851076|NCT02931838|147249286|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||<0.0001
73851077|NCT03419897|147249397|SUPERIORITY|||||||0.0001|||||||Binomial exact test|||Tislelizumab compared with historical ORR rate of 7%||||0.0001
73851078|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior frontal gyrus||||<0.05
73851079|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Desire to void: L superior temporal gyrus||||<0.05
73851080|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior temporal gyrus||||<0.05
73851081|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle temporal gyrus||||<0.05
73851082|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R middle temporal gyrus||||<0.05
73851083|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior parietal lobule||||<0.05
73851084|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R inferior parietal lobule||||<0.05
73851085|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R paracentral lobule||||<0.05
73851086|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R superior parietal lobule||||<0.05
73851087|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R supplementary motor area||||<0.05
73851088|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L postcentral gyrus||||<0.05
73851089|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R postcentral gyrus||||<0.05
73851090|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L angular gyrus||||<0.05
73851091|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R supramarginal gyrus||||<0.05
73851092|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L superior medial gyrus||||<0.05
73851093|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior occipital gyrus||||<0.05
73851094|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle cingulate cortex||||<0.05
73851095|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R middle cingulate cortex||||<0.05
73851096|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R posterior cingulate cortex||||<0.05
74024346|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.27||0.918|TWO_SIDED|95.0|-0.51|0.56|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.56|-0.51|0.918
73851097|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L thalamus||||<0.05
73851098|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R thalamus||||<0.05
73851099|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L precuneus||||<0.05
73851100|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R precuneus||||<0.05
73851101|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L caudate nucleus||||<0.05
73851102|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire void: L hippocampus||||<0.05
73851103|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L hippocampus||||<0.05
73851104|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L putamen||||<0.05
73851105|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L precentral gyrus||||<0.05
73851106|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R precentral gyrus||||<0.05
73851107|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L insula lobe||||<0.05
73851108|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L superior frontal gyrus||||<0.05
73851109|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle frontal gyrus||||<0.05
73851110|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R cerebellum||||<0.05
73851111|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R fusiform gyrus||||<0.05
73851112|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L postcentral gyrus||||<0.05
73851113|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R postcentral gyrus||||<0.05
73851114|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L precentral gyrus||||<0.05
73851115|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R precentral gyrus||||<0.05
73851116|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior temporal gyrus||||<0.05
73851117|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior temporal gyrus||||<0.05
73851118|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle temporal gyrus||||<0.05
73851119|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle temporal gyrus||||<0.05
73851120|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior temporal gyrus||||<0.05
73851121|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L supramarginal gyrus||||<0.05
73851122|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R supramarginal gyrus||||<0.05
73851123|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding Initiation: L inferior occipital gyrus||||<0.05
73851124|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior occipital gyrus||||<0.05
73851125|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding Initiation: R middle occipital gyrus||||<0.05
73851126|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Orbitalis)||||<0.05
73851127|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Triangularis)||||<0.05
73851128|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Opercularis)||||<0.05
73851129|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior frontal gyrus (p. Orbitalis)||||<0.05
73851130|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior frontal gyrus (p. Triangularis)||||<0.05
73851131|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L cerebellum||||<0.05
73851132|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L rectal gyrus||||<0.05
73851133|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R rectal gyrus||||<0.05
73851134|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior medial gyrus||||<0.05
73851135|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior medial gyrus||||<0.05
73851136|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior frontal gyrus||||<0.05
73851137|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior frontal gyrus||||<0.05
73851138|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle frontal gyrus||||<0.05
73851139|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle frontal gyrus||||<0.05
73851140|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L supplementary motor area (SMA)||||<0.05
73851141|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R SMA||||<0.05
73851142|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L paracentral lobule||||<0.05
73851143|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R paracentral lobule||||<0.05
73851144|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior parietal lobule||||<0.05
74024347|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.47|-0.4|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.40|-1.47|<0.001
74024348|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.27||0.013|TWO_SIDED|95.0|-1.22|-0.15|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-1.22|0.013
73851145|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior parietal lobule||||<0.05
73851146|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior orbital gyrus||||<0.05
73851147|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle orbital gyrus||||<0.05
73851148|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle orbital gyrus||||<0.05
73851149|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R calcarine gyrus||||<0.05
73851150|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L calcarine gyrus||||<0.05
73851151|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L anterior cingulate cortex||||<0.05
73851152|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle cingulate cortex||||<0.05
73851153|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle cingulate cortex||||<0.05
73851154|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R angular gyrus||||<0.05
73851155|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L thalamus||||<0.05
73851156|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R thalamus||||<0.05
73851157|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L precuneus||||<0.05
73851158|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R precuneus||||<0.05
73851159|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R caudate nucleus||||<0.05
73851160|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L putamen||||<0.05
73851161|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L amygdala||||<0.05
73851162|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R insula lobe||||<0.05
73851163|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L rolandic operculum||||<0.05
73851164|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L hippocampus||||<0.05
73851165|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R hippocampus||||<0.05
73851166|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R fusiform gyrus||||<0.05
73851167|NCT03574610|147249414|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R rolandic operculum||||<0.05
73851168|NCT03574610|147249415|OTHER|||||||0.45||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Voided volume - baseline vs post-treatment||||0.45
73851169|NCT03574610|147249415|OTHER|||||||0.39||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Voided volume - baseline vs 4 month follow-up||||0.39
73851170|NCT03574610|147249415|OTHER|||||||0.014||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||PVR - baseline vs post-treatment||||0.014
73851171|NCT03574610|147249415|OTHER|||||||0.66||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||PVR - baseline vs 4 month follow-up||||0.66
73851172|NCT03574610|147249415|OTHER|||||||0.31||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Bladder capacity - baseline vs post-treatment||||0.31
73851173|NCT03574610|147249415|OTHER|||||||0.001||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Bladder capacity - baseline vs 4 month follow-up||||0.001
73851174|NCT03574610|147249416|OTHER|||||||0.004||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||% PVR/BC - baseline vs post-treatment||||0.004
73851175|NCT03574610|147249416|OTHER|||||||0.038||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||%PVR/BC - baseline vs 4 month follow-up||||0.038
73851176|NCT03574610|147249417|OTHER|||||||0.19||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Qmax - baseline vs post-treatment||||0.19
73851177|NCT03574610|147249417|OTHER|||||||0.91||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Max - baseline vs 4 month follow-up||||0.91
73851178|NCT03574610|147249418|OTHER|||||||0.13||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Liverpool nomogram percentile - baseline vs post-treatment||||0.13
73851179|NCT03574610|147249418|OTHER|||||||0.26||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Liverpool nomogram percentile - baseline vs 4 month follow-up||||0.26
73851180|NCT03574610|147249419|OTHER|||||||0.4||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||UDI-6 Q1 - baseline vs post-treatment||||0.40
74024349|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.57|-0.49|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.49|-1.57|<0.001
74024350|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.27||0.003|TWO_SIDED|95.0|-1.36|-0.28|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-1.36|0.003
74084731|NCT01729026|147722765|SUPERIORITY_OR_OTHER_LEGACY||Effect size (Cohen's d)|-0.75||||0.141|TWO_SIDED|95.0|-1.85|0.35||Between baseline and 3-month follow-up, subjects in the Adoption group had a mean improvement of 15.20 points on the PCL-5 compared to 7.77 points in the Wait-list group.|Mixed effects regression models|||The analyses were mixed effect regression models with repeated measures at randomization (baseline) and at the 3-month post-randomization follow-up using a 2 x 2 design. Treatment (Adoption group vs Wait-list group), time (baseline and 3-month follow-up) and their interaction were the fixed design effects. The treatment by time interaction tests the significance of the difference between baseline and 3-month follow-up between the Adoption and Wait-list groups.||0.35|-1.85|0.141
74084732|NCT01729026|147722766|SUPERIORITY||effect size (Cohen's d)|0.0||||0.982|TWO_SIDED||||||effect size (Cohen's d)|||||||0.982
74024351|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.27||0.006|TWO_SIDED|95.0|-1.29|-0.21|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.21|-1.29|0.006
74084733|NCT01729026|147722767|SUPERIORITY||effect size (Cohen's d)|-0.5||||0.16|TWO_SIDED||||||effect size (Cohen's d)|||||||0.160
73851181|NCT03574610|147249419|OTHER|||||||0.086||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 Q1 - baseline vs 4 month follow-up||||0.086
73851182|NCT03574610|147249419|OTHER|||||||0.54||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test.||UDI-6 Q2 - baseline vs post-treatment||||0.54
73851183|NCT03574610|147249419|OTHER|||||||0.19||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 Q2 - baseline vs 4 month follow-up||||0.19
73851184|NCT03574610|147249419|OTHER|||||||0.04||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||UDI-6 Q5 - baseline vs post-treatment||||0.04
73851185|NCT03574610|147249419|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 5 - baseline vs 4 month follow-up||||0.026
73851186|NCT03574610|147249420|OTHER|||||||0.044||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q3 - baseline vs post-treatment||||0.044
73851187|NCT03574610|147249420|OTHER|||||||0.017||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q3 - baseline vs 4 month follow-up||||0.017
73851188|NCT03574610|147249420|OTHER|||||||0.54||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q5 - baseline vs post-treatment||||0.54
73851189|NCT03574610|147249420|OTHER|||||||0.503||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q5 - baseline vs 4 month follow-up||||0.503
73851190|NCT03574610|147249420|OTHER|||||||0.023||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q7 - baseline vs post-treatment||||0.023
73851191|NCT03574610|147249420|OTHER|||||||0.049||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q7 - baseline vs 4 month follow-up||||0.049
73851192|NCT03574610|147249420|OTHER|||||||0.089||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q8 - baseline vs post-treatment||||0.089
73851193|NCT03574610|147249420|OTHER|||||||0.161||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q8 - baseline vs 4 month follow-up||||0.161
73851194|NCT03574610|147249421|OTHER|||||||0.01||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Incontinence) - baseline vs post-treatment||||0.010
73851195|NCT03574610|147249421|OTHER|||||||0.41||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Incontinence) - baseline vs 4 month follow-up||||0.41
73851196|NCT03574610|147249421|OTHER|||||||0.32||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Storage and Voiding) - baseline vs post-treatment||||0.32
73851197|NCT03574610|147249421|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Storage and Voiding) - baseline vs 4 month follow-up||||0.02
73851198|NCT03574610|147249421|OTHER|||||||0.34||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Consequences) - baseline vs post-treatment||||0.34
73851199|NCT03574610|147249421|OTHER|||||||0.61||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Consequences) - baseline vs 4 month follow-up||||0.61
73851200|NCT03574610|147249421|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (QoL) - baseline vs post-treatment||||0.02
73851201|NCT03574610|147249421|OTHER|||||||0.07||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (QoL) - baseline vs 4 month follow-up||||0.07
73851202|NCT01032954|147249422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||P-value threshold for significance: \<0.05|GLM= GENERAL LINEAR MODELS WITH REPEATED|||||||<0.05
73851203|NCT01032954|147249423|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||P-value threshold for significance: \<0.05|GLM|||||||<0.05
73851204|NCT03759639|147249509|SUPERIORITY||Hodges-Lehmann Estimator|1.0||||0.029|TWO_SIDED|90.0|0.25|1.75|||1-sided Wilcoxon signed-rank test|||||1.75|0.25|0.029
73851205|NCT03759639|147249511|SUPERIORITY||Hodges-Lehmann Estimator|0.13||||0.318|TWO_SIDED|90.0|-0.25|0.5|||1-sided Wilcoxon signed-rank test|||||0.50|-0.25|0.318
73851206|NCT03759639|147249514|SUPERIORITY||Hodges-Lehmann Estimator|0.0854||||0.084|TWO_SIDED|90.0|-0.0123|0.1777|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||0.1777|-0.0123|0.084
73851207|NCT03759639|147249514|SUPERIORITY||Hodges-Lehmann Estimator|-0.0399||||0.315|TWO_SIDED|90.0|-0.1269|0.1031|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.1031|-0.1269|0.315
73851208|NCT03759639|147249515|SUPERIORITY||Hodges-Lehmann Estimator|-1.25||||0.001|TWO_SIDED|90.0|-1.75|-0.5|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||-0.50|-1.75|0.001
73851209|NCT03759639|147249515|SUPERIORITY||Hodges-Lehmann Estimator|1.25||||0.002|TWO_SIDED|90.0|0.5|2.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||2.00|0.50|0.002
73851210|NCT03759639|147249517|SUPERIORITY||Hodges-Lehmann Estimator|0.0||||0.121|TWO_SIDED|90.0|-0.021|0.0|||1-sided Wilcoxon signed-rank test|||Treatment with IB1001||0.000|-0.021|0.121
73851211|NCT03759639|147249517|SUPERIORITY||Hodges-Lehmann Estimator|0.021||||0.056|TWO_SIDED|90.0|0.0|0.042|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.042|0.000|0.056
73851212|NCT03759639|147249518|SUPERIORITY||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||<0.001
73851213|NCT03759639|147249518|SUPERIORITY||Mean Difference (Net)|4.5||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Post-Treatment Washout||||0.006
73851214|NCT03759639|147249519|SUPERIORITY||Mean Difference (Net)|3.4||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||0.005
74024352|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.87|-0.79|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.79|-1.87|<0.001
74024353|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.68|-0.53|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.53|-1.68|<0.001
73851215|NCT03759639|147249519|SUPERIORITY||Mean Difference (Net)|4.4||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||0.038
73901678|NCT04102189|147333471|SUPERIORITY||Treatment difference|-16.75|||<|0.0001|TWO_SIDED|95.0|-20.27|-13.23|||ANCOVA|||Responses were analyzed using an analysis of covariance model with randomized treatment, stratification groups (sex and Tanner stage at baseline) and the interaction between stratification groups as factors and baseline BMI as covariate.||-13.23|-20.27|<.0001
73851216|NCT03759639|147249520|SUPERIORITY||Mean Difference (Net)|3.3||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment with IB1001||||0.003
73851217|NCT03759639|147249520|SUPERIORITY||Mean Difference (Net)|4.4||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Post-Treatment Washout||||0.034
73851218|NCT00958360|147249525|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
73851219|NCT00958360|147249526|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
73901689|NCT03976323|147333530|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.8721|TWO_SIDED|95.0|0.92|1.36||One-sided p-value based on log-rank test stratified by Eastern Cooperative Oncology Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.36|0.92|0.8721
73901690|NCT03976323|147333531|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6649|TWO_SIDED|95.0|0.87|1.25||One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.25|0.87|0.6649
74024354|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|-1.48|-0.33|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.33|-1.48|0.002
74024355|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.87|-0.72|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.72|-1.87|<0.001
73901691|NCT03976323|147333534|SUPERIORITY||Difference in Least Squares (LS) Means|-1.9||||0.2533|TWO_SIDED|95.0|-5.16|1.36||Two-sided p-value based on t test.|t-test, 2 sided||Based on constrained longitudinal data analysis model (cLDA) model with PRO scores as response variable with covariates for treatment by time interaction, stratification factors, response at randomization and baseline PD-L1 expression as covariates.|||1.36|-5.16|0.2533
74024356|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.31||0.027|TWO_SIDED|95.0|-1.28|-0.08|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-1.28|0.027
73851220|NCT00958360|147249527|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
73851221|NCT00958360|147249528|SUPERIORITY_OR_OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
73851222|NCT00958360|147249529|SUPERIORITY_OR_OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
73851223|NCT00336284|147249552|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73851224|NCT00336284|147249553|NON_INFERIORITY_OR_EQUIVALENCE|Sample size of the study is based on the safety endpoint and based on a Blackwelder type test of non inferiority with the standard design criteria: Type I error (one-sided), statistical power of 80%, and 2:1 randomization. The evaluation of the primary safety endpoint was based on an exact binomial non-inferiority test comparing the proportions of patient deaths, strokes or surgical interventions.||||||0.005||95.0|||||Exact binomial test for non-inferiority|1-sided||||||0.005
73851225|NCT00336284|147249554|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
73851226|NCT00861757|147249560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.003|TWO_SIDED|95.0|-3.0|-0.6|||ANCOVA|||||-0.6|-3.0|0.003
73851227|NCT00861757|147249560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.004|TWO_SIDED|95.0|-2.9|-0.6|||ANCOVA|||||-0.6|-2.9|0.004
73851228|NCT00861757|147249560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.7|-1.3|||ANCOVA|||||-1.3|-3.7|<0.001
73851229|NCT00861757|147249561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.2|-0.6||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-0.6|-2.2|<0.001
73851230|NCT00861757|147249561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.005|TWO_SIDED|95.0|-1.9|-0.3||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-0.3|-1.9|0.005
73851231|NCT00861757|147249561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.7|-1.1||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-1.1|-2.7|<0.001
73851232|NCT00861757|147249561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.072|TWO_SIDED|95.0|-1.0|0.0||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||0.0|-1.0|0.072
73851233|NCT00861757|147249561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.021|TWO_SIDED|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||-0.1|-1.1|0.021
74024357|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.31||0.071|TWO_SIDED|95.0|-1.15|0.05|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.05|-1.15|0.071
73851234|NCT00861757|147249561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.023|TWO_SIDED|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||-0.1|-1.1|0.023
73851235|NCT00861757|147249562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.031|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.031
73851236|NCT00861757|147249562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.013|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|0.013
73851237|NCT00861757|147249562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|||||-0.4|-0.9|<0.001
73851238|NCT00861757|147249563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.201|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||||0.2|-1.0|0.201
73851239|NCT00861757|147249563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.393|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.393
73851240|NCT00861757|147249563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.4|-0.2|||ANCOVA|||||-0.2|-1.4|0.007
73851241|NCT00861757|147249564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.5||0.331|TWO_SIDED|95.0|-1.6|0.5|||ANCOVA|||||0.5|-1.6|0.331
74024358|NCT00733902|147600900|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-1.78|-0.58|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.78|<0.001
74024359|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.27||0.326|TWO_SIDED|95.0|-0.8|0.27|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.27|-0.80|0.326
73851242|NCT00861757|147249564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.14|TWO_SIDED|95.0|-1.8|0.3|||ANCOVA|||||0.3|-1.8|0.140
73851243|NCT00861757|147249564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.94|TWO_SIDED|95.0|-1.1|1.0|||ANCOVA|||||1.0|-1.1|0.940
73851244|NCT00861757|147249565|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
73851245|NCT00861757|147249565|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
73851246|NCT00861757|147249565|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (placebo vs 0.2 mg Tamsulosin) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
73851247|NCT00861757|147249566|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.034
73901692|NCT03976323|147333535|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8125|TWO_SIDED|95.0|0.76|1.24||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.24|0.76|0.8125
73901693|NCT03976323|147333536|SUPERIORITY||Difference in LS Means|-0.16||||0.9364|TWO_SIDED|95.0|-4.02|3.71||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||3.71|-4.02|0.9364
73901694|NCT03976323|147333537|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3782|TWO_SIDED|95.0|0.66|1.17||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.17|0.66|0.3782
73901695|NCT03976323|147333538|SUPERIORITY||Difference in LS Means|-0.35||||0.8285|TWO_SIDED|95.0|-3.54|2.83||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.83|-3.54|0.8285
73901696|NCT03976323|147333539|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6272|TWO_SIDED|95.0|0.78|1.51||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.51|0.78|0.6272
73901697|NCT03976323|147333540|SUPERIORITY||Difference in LS Means|-1.51||||0.4422|TWO_SIDED|95.0|-5.38|2.35||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.35|-5.38|0.4422
73901698|NCT03976323|147333541|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9156|TWO_SIDED|95.0|0.74|1.31||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.31|0.74|0.9156
73901699|NCT03976323|147333542|SUPERIORITY||Difference in LS Means|-0.01||||0.9962|TWO_SIDED|95.0|-2.94|2.93||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.93|-2.94|0.9962
73901700|NCT03976323|147333543|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5517|TWO_SIDED|95.0|0.83|1.4||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.40|0.83|0.5517
73930713|NCT03238911|147391295|SUPERIORITY||Mean Difference (Final Values)|0.055||||0.1282|TWO_SIDED|95.0|-0.016|0.126|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.126|-0.016|0.1282
73851248|NCT00861757|147249566|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.002
73851249|NCT00861757|147249566|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 0.2 mg Tamsulosin) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.001
73930714|NCT03238911|147391297|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.4618|TWO_SIDED|95.0|-0.82|0.37|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.37|-0.82|0.4618
73930715|NCT03238911|147391297|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.366|TWO_SIDED|95.0|-0.54|0.2|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.20|-0.54|0.3660
74084734|NCT01729026|147722768|SUPERIORITY||effect size (Cohen's d)|-1.36||||0.015|TWO_SIDED|95.0|-2.49|-0.23|||effect size (Cohen's d)|||||-0.23|-2.49|0.015
74084735|NCT01729026|147722769|SUPERIORITY||effect size (Cohen's d)|0.2||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
74084736|NCT01729026|147722770|SUPERIORITY||mixed effects regression models|-1.41||||0.01|TWO_SIDED|95.0|-2.5|-0.31|||effect size (Cohen's d)|||||-0.31|-2.50|0.010
74084737|NCT01729026|147722771|SUPERIORITY|||||||0.13|||||||Fisher Exact|||||||0.13
74084738|NCT01729026|147722772|SUPERIORITY||effect size (Cohen's d)|0.9||||0.188|TWO_SIDED||||||effect size (Cohen's d)|||||||0.188
74084739|NCT01729026|147722774|SUPERIORITY||effect size (Cohen's d)|1.2||||0.031|TWO_SIDED||||||mixed effects regression models|||||||0.031
73901701|NCT03050775|147333553|SUPERIORITY|||||||0.807|||||||t-test, 2 sided|||||||0.807
73901702|NCT03050775|147333553|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.358|TWO_SIDED|95.0|-0.085|0.237|||ANCOVA|||||0.237|-0.085|0.358
73901703|NCT03050775|147333554|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.823|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||\~30 minutes post-induction||0.2|-0.3|0.823
73901704|NCT03050775|147333554|SUPERIORITY||Median Difference (Final Values)|0.0||||0.853|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||\~60 minutes post-induction. Data was obtained from 33 subjects in the treatment group.||0.3|-0.2|0.853
73851250|NCT00861757|147249567|SUPERIORITY_OR_OTHER|||||||0.412||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.412
73851251|NCT00861757|147249567|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.083
73851252|NCT00861757|147249567|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.456
73851253|NCT00861757|147249568|SUPERIORITY_OR_OTHER|||||||0.688||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.688
73851254|NCT00861757|147249568|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.510
73851255|NCT00861757|147249568|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.212
73851256|NCT00861757|147249569|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.005
73851257|NCT00861757|147249569|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.274
73851258|NCT00861757|147249569|SUPERIORITY_OR_OTHER|||||||0.538||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.538
73901705|NCT03050775|147333554|SUPERIORITY||Median Difference (Final Values)|0.0||||0.986|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||\~120 minutes post-induction||0.2|-0.2|0.986
73901706|NCT03050775|147333555|SUPERIORITY||Odds Ratio (OR)|1.7||||0.54|TWO_SIDED|95.0|0.5|5.9|||Fisher Exact|||Post-operative shivering observed||5.9|0.5|0.540
73901707|NCT03050775|147333556|SUPERIORITY||Median Difference (Final Values)|0.0||||0.672|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-1|0.672
73901708|NCT03050775|147333557|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.571|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||Data was obtained from 32 subjects in the treatment group.||0.1|-0.2|0.571
73851259|NCT00861757|147249569|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.008
73851260|NCT00861757|147249569|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.216
73851261|NCT00861757|147249569|SUPERIORITY_OR_OTHER|||||||0.524||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.524
73851262|NCT00861757|147249570|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.007
73851263|NCT00861757|147249570|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.723
73851264|NCT00861757|147249570|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.273
73851265|NCT00861757|147249570|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.005
73851266|NCT00861757|147249570|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.054
73851267|NCT00861757|147249570|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.278
73851268|NCT00861757|147249571|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Wilcoxon rank-sum test|||||||0.330
73851269|NCT00861757|147249571|SUPERIORITY_OR_OTHER|||||||0.838||95.0|||||Wilcoxon rank-sum test|||||||0.838
73851270|NCT00861757|147249571|SUPERIORITY_OR_OTHER|||||||0.409||95.0|||||Wilcoxon rank-sum test|||||||0.409
73901709|NCT03050775|147333558|SUPERIORITY||Odds Ratio (OR)|1.4||||0.619|TWO_SIDED|95.0|0.5|3.7|||Fisher Exact|||||3.7|0.5|0.619
73901710|NCT03050775|147333559|SUPERIORITY||Median Difference (Final Values)|75.0||||0.404|TWO_SIDED|95.0|-100.0|250.0|||Wilcoxon (Mann-Whitney)|||||250|-100|0.404
73901711|NCT03274999|147333563|SUPERIORITY|||||||0.156||||||Eye-opening, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.156
73901712|NCT03274999|147333563|SUPERIORITY|||||||0.395||||||Eye-opening, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.395
73901713|NCT03274999|147333563|SUPERIORITY|||||||0.114||||||Eye-opening, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.114
73901714|NCT03274999|147333563|SUPERIORITY|||||||0.211||||||Eye-opening, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.211
73901715|NCT03274999|147333563|SUPERIORITY|||||||0.332||||||Eye-opening, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.332
74084740|NCT01729026|147722775|SUPERIORITY||effect size (Cohen's d)|0.3||||0.541|TWO_SIDED|95.0|-0.8|1.4|||effect size (Cohen's d)|||||1.40|-0.80|0.541
73851271|NCT03308968|147249572|OTHER||Least square (LS) mean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.84|-2.42|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.||-2.42|-3.84|<0.0001
73901716|NCT03274999|147333563|SUPERIORITY|||||||0.318||||||Eye-opening, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.318
73901717|NCT03274999|147333563|SUPERIORITY|||||||0.375||||||Eye-opening, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.375
73961819|NCT01641198|147460335|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED|95.0|0.09|0.69||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||0.69|0.09|<0.05
73961820|NCT01641198|147460335|SUPERIORITY||Mean Difference (Final Values)|-0.685|STANDARD_ERROR_OF_MEAN|0.115|<|0.05|TWO_SIDED|95.0|-0.98|-0.39||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)||-0.39|-0.98|<0.05
73961821|NCT01641198|147460336|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.135|<|0.05|TWO_SIDED|95.0|-0.47|0.13||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.13|-0.47|<0.05
73961822|NCT01641198|147460336|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|95.0|0.26|0.85||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||0.85|0.26|<0.05
73961823|NCT01641198|147460336|SUPERIORITY||Mean Difference (Final Values)|-0.725|STANDARD_ERROR_OF_MEAN|0.135|<|0.05|TWO_SIDED|95.0|-1.02|-0.43||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)||-0.43|-1.02|<0.05
74024360|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.275|TWO_SIDED|95.0|-0.24|0.83|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.83|-0.24|0.275
73851272|NCT03308968|147249572|OTHER||LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-4.19|-2.78|||ANCOVA|||Analysis was performed using ANCOVA method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.||-2.78|-4.19|<0.0001
73851273|NCT02482298|147249608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.06367|||TWO_SIDED|90.0|-0.061|0.151|||Mixed Models Analysis|||||0.1510|-0.0610|
73851274|NCT02482298|147249608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0801|STANDARD_ERROR_OF_MEAN|0.06192|||TWO_SIDED|90.0|-0.023|0.1832|||Mixed Models Analysis|||||0.1832|-0.0230|
73851275|NCT02482298|147249610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1192|STANDARD_ERROR_OF_MEAN|0.05059|||TWO_SIDED|90.0|0.035|0.2035|||Mixed Models Analysis|||||0.2035|0.0350|
73851276|NCT02482298|147249610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0975|STANDARD_ERROR_OF_MEAN|0.04923|||TWO_SIDED|90.0|0.0155|0.1795|||Mixed Models Analysis|||||0.1795|0.0155|
73901718|NCT03274999|147333563|SUPERIORITY|||||||0.352||||||Eye-opening, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.352
73901719|NCT03274999|147333563|SUPERIORITY|||||||0.312||||||Eye-opening, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.312
73901720|NCT03274999|147333563|SUPERIORITY|||||||0.134||||||Pre-blink, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.134
73901721|NCT03274999|147333563|SUPERIORITY|||||||0.315||||||Pre-blink, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.315
73901722|NCT03274999|147333563|SUPERIORITY|||||||0.071||||||Pre-blink, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.071
73961824|NCT01641198|147460337|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|-0.19|0.59||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.59|-0.19|<0.05
73961825|NCT01641198|147460337|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|0.45|1.22||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||1.22|0.45|<0.05
73961826|NCT01641198|147460337|SUPERIORITY||Mean Difference (Final Values)|-0.635|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|-1.01|-0.26||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI).||-0.26|-1.01|<0.05
73961827|NCT01075217|147460369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|2.45|<|0.0001|TWO_SIDED|95.0|1.4|3.5||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 1, i.e., pain was not assessed separately from heat.|t-test, 2 sided|||||3.5|1.4|<0.0001
73961828|NCT01075217|147460369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|1.94||0.3244|TWO_SIDED|95.0|-0.5|1.4||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 2, i.e., pain was assessed separately from heat.|t-test, 2 sided|||||1.4|-0.5|0.3244
73901723|NCT03274999|147333563|SUPERIORITY|||||||0.26||||||Pre-blink, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.260
73901724|NCT03274999|147333563|SUPERIORITY|||||||0.264||||||Pre-blink, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.264
73901725|NCT03274999|147333563|SUPERIORITY|||||||0.381||||||Pre-blink, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.381
73961829|NCT01075217|147460370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|2.35||0.0059|TWO_SIDED|95.0|0.5|2.7|||t-test, 2 sided|||||2.7|0.5|0.0059
73961830|NCT01068743|147460374|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|101.45|||||TWO_SIDED|90.0|98.17|104.84|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries. LS=Least Squares.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||104.84|98.17|
73961831|NCT01068743|147460374|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.43|||||TWO_SIDED|90.0|99.53|105.42|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf,respectively.||105.42|99.53|
73901726|NCT03274999|147333563|SUPERIORITY|||||||0.249||||||Pre-blink, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.249
73901727|NCT03274999|147333563|SUPERIORITY|||||||0.451||||||Pre-blink, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.451
73901728|NCT03274999|147333563|SUPERIORITY|||||||0.393||||||Pre-blink, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.393
73961832|NCT01068743|147460374|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|49.23||||||||||||||Geometric least squares means for Treatment A.||||
73901729|NCT03274999|147333564|SUPERIORITY|||||||0.006||||||Eye-opening, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.006
73851277|NCT03012828|147249623|OTHER|The model was used for predicting population average and 90% 2-sided bootstrapped CI of the baseline-adjusted difference between active and placebo at each time point bound at clinically relevant concentrations.|Slope|-0.0077||||0.4727|TWO_SIDED|90.0|-0.0255|0.0101|||Mixed Models Analysis||The primary mixed effects model analysis revealed a nearly flat dQTcF - plasma concentration gradient|The primary analysis used a mixed-effects model to explore the relationship between the time-matched, baseline-adjusted QTcF (delta (d)QTcF) and moxidectin concentrations. dQTcF was a dependent variable and treatment, time point, and treatment by time point interaction as the independent variables with baseline QTcF as a covariate and time-matched concentrations of moxidectin as a covariate with random effects of intercept and slope for each subject.Concentrations of zero were used for placebo.||0.0101|-0.0255|0.4727
73851278|NCT00763256|147249631|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
73851279|NCT00763256|147249632|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
73851280|NCT00763256|147249633|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
73851281|NCT00763256|147249634|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
73851282|NCT00763256|147249635|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
73851283|NCT04855240|147249662|SUPERIORITY||LSM difference|-10.5|STANDARD_ERROR_OF_MEAN|7.61||0.1683|TWO_SIDED|95.0|-25.4|4.4|||ANOVA|||||4.4|-25.4|0.1683
73851284|NCT04855240|147249662|SUPERIORITY||LSM difference|1.6|STANDARD_ERROR_OF_MEAN|7.64||0.8356|TWO_SIDED|95.0|-13.4|16.6|||ANOVA|||||16.6|-13.4|0.8356
73851285|NCT04855240|147249663|SUPERIORITY||Hazard Ratio (HR)|0.831||||0.228|TWO_SIDED|95.0|0.598|1.155|||Log Rank|||||1.155|0.598|0.2280
73851286|NCT04855240|147249663|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5604|TWO_SIDED|95.0|0.793|1.527|||Log Rank|||||1.527|0.793|0.5604
73851287|NCT04855240|147249664|SUPERIORITY||Risk Difference (RD)|0.11||||0.2457|TWO_SIDED|95.0|-0.05|0.26|||Cochran-Mantel-Haenszel|||||0.26|-0.05|0.2457
73851288|NCT04855240|147249664|SUPERIORITY||Risk Difference (RD)|-0.06||||0.3997|TWO_SIDED|95.0|-0.22|0.09|||Cochran-Mantel-Haenszel|||||0.09|-0.22|0.3997
73851289|NCT04855240|147249665|SUPERIORITY||Risk Difference (RD)|0.07||||0.4771|TWO_SIDED|95.0|-0.09|0.22|||Cochran-Mantel-Haenszel|||||0.22|-0.09|0.4771
73851290|NCT04855240|147249665|SUPERIORITY||Risk Difference (RD)|-0.09||||0.2925|TWO_SIDED|95.0|-0.24|0.06|||Cochran-Mantel-Haenszel|||||0.06|-0.24|0.2925
73851291|NCT04855240|147249666|SUPERIORITY||Risk Difference (RD)|0.07||||0.4628|TWO_SIDED|95.0|-0.09|0.22|||Cochran-Mantel-Haenszel|||||0.22|-0.09|0.4628
73851292|NCT04855240|147249666|SUPERIORITY||Risk Difference (RD)|-0.09||||0.309|TWO_SIDED|95.0|-0.24|0.06|||Cochran-Mantel-Haenszel|||||0.06|-0.24|0.3090
73851293|NCT04855240|147249667|SUPERIORITY||LSM difference|-17.7|STANDARD_ERROR_OF_MEAN|15.36||0.2494|TWO_SIDED|95.0|-47.8|12.4|||ANOVA|||||12.4|-47.8|0.2494
73851294|NCT04855240|147249667|SUPERIORITY||LSM difference|5.1|STANDARD_ERROR_OF_MEAN|15.42||0.7385|TWO_SIDED|95.0|-25.1|35.4|||ANOVA|||||35.4|-25.1|0.7385
73851295|NCT04855240|147249668|SUPERIORITY||LSM difference|-22.6|STANDARD_ERROR_OF_MEAN|22.91||0.3238|TWO_SIDED|95.0|-67.5|22.3|||ANOVA|||||22.3|-67.5|0.3238
73851296|NCT04855240|147249668|SUPERIORITY||LSM difference|7.8|STANDARD_ERROR_OF_MEAN|22.99||0.7344|TWO_SIDED|95.0|-37.3|52.9|||ANOVA|||||52.9|-37.3|0.7344
73851297|NCT04855240|147249669|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|1.72||0.8489|TWO_SIDED|95.0|-3.7|3.0|||ANOVA|||||3.0|-3.7|0.8489
73851298|NCT04855240|147249669|SUPERIORITY||LSM difference|1.9|STANDARD_ERROR_OF_MEAN|1.72||0.2768|TWO_SIDED|95.0|-1.5|5.3|||ANOVA|||||5.3|-1.5|0.2768
73851299|NCT04855240|147249670|SUPERIORITY||LSM difference|-1.2|STANDARD_ERROR_OF_MEAN|2.54||0.6291|TWO_SIDED|95.0|-6.2|3.8|||ANOVA|||||3.8|-6.2|0.6291
73901730|NCT03274999|147333564|SUPERIORITY|||||||0.063||||||Eye-opening, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.063
73901731|NCT03274999|147333564|SUPERIORITY|||||||0.005||||||Eye-opening, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.005
73901732|NCT03274999|147333564|SUPERIORITY|||||||0.089||||||Eye-opening, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.089
73901733|NCT03274999|147333564|SUPERIORITY|||||||0.112||||||Eye-opening, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.112
73901734|NCT03274999|147333564|SUPERIORITY|||||||0.16||||||Eye-opening, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.16
73961833|NCT01068743|147460374|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|49.94||||||||||||||Geometric least squares means for Treatment B.||||
73851300|NCT04855240|147249670|SUPERIORITY||LSM difference|2.5|STANDARD_ERROR_OF_MEAN|2.55||0.3182|TWO_SIDED|95.0|-2.5|7.5|||ANOVA|||||7.5|-2.5|0.3182
73851301|NCT04855240|147249671|SUPERIORITY||LSM difference|-4.2|STANDARD_ERROR_OF_MEAN|4.35||0.3299|TWO_SIDED|95.0|-12.8|4.3|||ANOVA|||||4.3|-12.8|0.3299
73851302|NCT04855240|147249671|SUPERIORITY||LSM difference|0.6|STANDARD_ERROR_OF_MEAN|4.37||0.8822|TWO_SIDED|95.0|-7.9|9.2|||ANOVA|||||9.2|-7.9|0.8822
73961834|NCT01068743|147460374|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|52.71||||||||||||||Geometric least squares means for Treatment C.||||
73961835|NCT01068743|147460374|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|53.99||||||||||||||Geometric least squares means for Treatment D.||||
74024361|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.27||0.918|TWO_SIDED|95.0|-0.51|0.56|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.56|-0.51|0.918
73851303|NCT04855240|147249672|SUPERIORITY||LSM difference|-7.1|STANDARD_ERROR_OF_MEAN|8.62||0.4094|TWO_SIDED|95.0|-24.0|9.8|||ANOVA|||||9.8|-24.0|0.4094
73961836|NCT01068743|147460377|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.46|||||TWO_SIDED|90.0|94.68|110.88|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||110.88|94.68|
73961837|NCT01068743|147460377|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|106.24|||||TWO_SIDED|90.0|98.43|114.66|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||114.66|98.43|
73961838|NCT01068743|147460377|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|9.73||||||||||||||Geometric least squares means for Treatment A.||||
73961839|NCT01068743|147460377|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|9.97||||||||||||||Geometric least squares means for Treatment B.||||
73961840|NCT01068743|147460377|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|10.33||||||||||||||Geometric least squares means for Treatment C.||||
73961841|NCT01068743|147460377|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|10.97||||||||||||||Geometric least squares means for Treatment D.||||
73851304|NCT04855240|147249672|SUPERIORITY||LSM difference|3.4|STANDARD_ERROR_OF_MEAN|8.65||0.6901|TWO_SIDED|95.0|-13.5|20.4|||ANOVA|||||20.4|-13.5|0.6901
73851305|NCT04855240|147249673|SUPERIORITY||LSM difference|-5.1|STANDARD_ERROR_OF_MEAN|8.59||0.5536|TWO_SIDED|95.0|-21.9|11.7|||ANOVA|||||11.7|-21.9|0.5536
74024362|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.39|-0.32|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.39|0.002
74084741|NCT01729026|147722776|SUPERIORITY||effect size (Cohen's d)|0.6||||0.139|TWO_SIDED||||||effect size (Cohen's d)|||Please note that a minus number indicates an increase in pain ratings.||||0.139
73851306|NCT04855240|147249673|SUPERIORITY||LSM difference|2.4|STANDARD_ERROR_OF_MEAN|8.64||0.7811|TWO_SIDED|95.0|-14.5|19.3|||ANOVA|||||19.3|-14.5|0.7811
73851307|NCT04855240|147249674|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.5267|TWO_SIDED|95.0|-0.8|0.4|||ANOVA|||||0.4|-0.8|0.5267
73851308|NCT04855240|147249674|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.29||0.3228|TWO_SIDED|95.0|-0.3|0.9|||ANOVA|||||0.9|-0.3|0.3228
73851309|NCT04855240|147249675|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.7617|TWO_SIDED|95.0|-0.5|0.4|||ANOVA|||||0.4|-0.5|0.7617
73851310|NCT04855240|147249675|SUPERIORITY||LSM difference|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6241|TWO_SIDED|95.0|-0.4|0.6|||ANOVA|||||0.6|-0.4|0.6241
73851311|NCT04855240|147249676|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3442|TWO_SIDED|95.0|-0.5|0.2|||ANOVA|||||0.2|-0.5|0.3442
73851312|NCT04855240|147249676|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.7896|TWO_SIDED|95.0|-0.3|0.4|||ANOVA|||||0.4|-0.3|0.7896
73851313|NCT04855240|147249677|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.49||0.6003|TWO_SIDED|95.0|-1.2|0.7|||ANOVA|||||0.7|-1.2|0.6003
73961842|NCT01068743|147460378|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|102.1|||||TWO_SIDED|90.0|97.26|107.18|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||107.18|97.26|
74024363|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.27||0.052|TWO_SIDED|95.0|-1.06|0.0|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.00|-1.06|0.052
74088264|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-4.52|STANDARD_ERROR_OF_MEAN|2.85||0.1157|TWO_SIDED|95.0|-10.16|1.13|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||1.13|-10.16|0.1157
74088265|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|2.41||0.5845|TWO_SIDED|95.0|-6.12|3.47|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.47|-6.12|0.5845
73851314|NCT04855240|147249677|SUPERIORITY||LSM difference|0.4|STANDARD_ERROR_OF_MEAN|0.49||0.4086|TWO_SIDED|95.0|-0.6|1.4|||ANOVA|||||1.4|-0.6|0.4086
73851315|NCT04855240|147249678|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.61||0.4958|TWO_SIDED|95.0|-1.6|0.8|||ANOVA|||||0.8|-1.6|0.4958
73851316|NCT04855240|147249678|SUPERIORITY||LSM difference|0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4595|TWO_SIDED|95.0|-0.8|1.7|||ANOVA|||||1.7|-0.8|0.4595
73851317|NCT04855240|147249679|SUPERIORITY||Risk Difference (RD)|0.08||||0.1686|TWO_SIDED|95.0|-0.04|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.04|0.1686
73851318|NCT04855240|147249679|SUPERIORITY||Risk Difference (RD)|0.0||||0.8333|TWO_SIDED|95.0|-0.1|0.11|||Cochran-Mantel-Haenszel|||||0.11|-0.10|0.8333
73851319|NCT04855240|147249680|SUPERIORITY||Risk Difference (RD)|0.09||||0.1939|TWO_SIDED|95.0|-0.02|0.2|||Cochran-Mantel-Haenszel|||||0.20|-0.02|0.1939
73851320|NCT04855240|147249680|SUPERIORITY||Risk Difference (RD)|0.0||||0.9595|TWO_SIDED|95.0|-0.1|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.10|0.9595
73851321|NCT04855240|147249681|SUPERIORITY||Risk Difference (RD)|0.09||||0.1894|TWO_SIDED|95.0|-0.02|0.2|||Cochran-Mantel-Haenszel|||||0.20|-0.02|0.1894
73851322|NCT04855240|147249681|SUPERIORITY||Risk Difference (RD)|0.0||||0.9595|TWO_SIDED|95.0|-0.1|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.10|0.9595
73851323|NCT04855240|147249682|SUPERIORITY||Risk Difference (RD)|0.09||||0.7117|TWO_SIDED|95.0|-0.06|0.24|||Cochran-Mantel-Haenszel|||||0.24|-0.06|0.7117
73851324|NCT04855240|147249682|SUPERIORITY||Risk Difference (RD)|-0.04||||0.7599|TWO_SIDED|95.0|-0.19|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.19|0.7599
73851325|NCT04855240|147249683|SUPERIORITY||Risk Difference (RD)|0.0||||0.707|TWO_SIDED|95.0|-0.16|0.16|||Cochran-Mantel-Haenszel|||||0.16|-0.16|0.7070
73851326|NCT04855240|147249683|SUPERIORITY||Risk Difference (RD)|-0.04||||0.6877|TWO_SIDED|95.0|-0.2|0.12|||Cochran-Mantel-Haenszel|||||0.12|-0.20|0.6877
73851327|NCT04855240|147249684|SUPERIORITY||Risk Difference (RD)|-0.07||||0.869|TWO_SIDED|95.0|-0.22|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.22|0.8690
73901735|NCT03274999|147333564|SUPERIORITY|||||||0.077||||||Eye-opening, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.077
73851328|NCT04855240|147249684|SUPERIORITY||Risk Difference (RD)|-0.04||||0.379|TWO_SIDED|95.0|-0.19|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.19|0.3790
73851329|NCT04855240|147249685|SUPERIORITY||LSM difference|5.9|STANDARD_ERROR_OF_MEAN|3.49||0.0897|TWO_SIDED|95.0|-0.9|12.8|||ANOVA|||||12.8|-0.9|0.0897
73851330|NCT04855240|147249685|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|3.5||0.9434|TWO_SIDED|95.0|-7.1|6.7|||ANOVA|||||6.7|-7.1|0.9434
73851331|NCT04855240|147249686|SUPERIORITY||Risk Difference (RD)|0.09||||0.8355|TWO_SIDED|95.0|-0.04|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.04|0.8355
73851332|NCT04855240|147249686|SUPERIORITY||Risk Difference (RD)|0.02||||0.3561|TWO_SIDED|95.0|-0.12|0.15|||Cochran-Mantel-Haenszel|||||0.15|-0.12|0.3561
73851333|NCT04855240|147249687|SUPERIORITY||Risk Difference (RD)|0.04||||0.9413|TWO_SIDED|95.0|-0.06|0.13|||Cochran-Mantel-Haenszel|||||0.13|-0.06|0.9413
73851334|NCT04855240|147249687|SUPERIORITY||Risk Difference (RD)|-0.04||||0.7819|TWO_SIDED|95.0|-0.15|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.15|0.7819
73851335|NCT04855240|147249688|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.8461|TWO_SIDED|95.0|-0.5|0.4|||ANOVA|||||0.4|-0.5|0.8461
73851336|NCT04855240|147249688|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1727|TWO_SIDED|95.0|-0.1|0.7|||ANOVA|||||0.7|-0.1|0.1727
73851337|NCT04855240|147249689|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.9022|TWO_SIDED|95.0|-0.4|0.5|||ANOVA|||||0.5|-0.4|0.9022
73851338|NCT04855240|147249689|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.245|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|||||0.7|-0.2|0.2450
73851339|NCT04855240|147249690|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.4205||0.4205|TWO_SIDED|95.0|-0.2|0.6|||ANOVA|||||0.6|-0.2|0.4205
73851340|NCT04855240|147249690|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4336|TWO_SIDED|95.0|-0.2|0.6|||ANOVA|||||0.6|-0.2|0.4336
73851341|NCT04855240|147249691|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.2718|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|||||0.7|-0.2|0.2718
73851342|NCT04855240|147249691|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1727|TWO_SIDED|95.0|-0.1|0.7|||ANOVA|||||0.7|-0.1|0.1727
73851343|NCT00244725|147249694|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45||||0.012|TWO_SIDED|95.0|1.1|1.9|||Fisher Exact|||||1.9|1.1|0.012
73851344|NCT00244725|147249694|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.42||||0.017|TWO_SIDED|95.0|1.1|1.9|||Fisher Exact|||||1.9|1.1|0.017
73851345|NCT00244725|147249694|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.32||||0.08|TWO_SIDED|95.0|1.0|1.8|||Fisher Exact|||||1.8|1.0|0.080
73851346|NCT01539070|147249793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|||<|0.05|TWO_SIDED|95.0|1.8|10.8|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in the average vegetable consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||10.8|1.8|<0.05
73851347|NCT01539070|147249793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-13.6|10.3|||Regression, Linear||The change in the average fruit consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||10.3|-13.6|<0.05
73851348|NCT01539070|147249793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||<|0.05|TWO_SIDED|95.0|-5.4|6.5|||Regression, Linear||The change in the average water consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||6.5|-5.4|<0.05
73851349|NCT01539070|147249793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|||<|0.05|TWO_SIDED|95.0|-8.9|1.1|||Regression, Linear||The change in the average sweet snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-8.9|<0.05
73851350|NCT01539070|147249793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED|95.0|-0.5|1.1|||Regression, Linear||The change in the average fast food consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-0.5|<0.05
73851351|NCT01539070|147249793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.05|TWO_SIDED|95.0|-0.5|0.0|||Regression, Linear||The change in the average savory snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.0|-0.5|<0.05
73851352|NCT01539070|147249793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.05|TWO_SIDED|95.0|-4.9|3.4|||Regression, Linear||The change in the average sugar-sweetened beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||3.4|-4.9|<0.05
73851353|NCT01539070|147249793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.05|TWO_SIDED|95.0|-8.4|4.1|||Regression, Linear||The change in the average added sugar in beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||4.1|-8.4|<0.05
73851354|NCT01539070|147249794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|||<|0.05|TWO_SIDED|95.0|-29.1|5.5|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in mean physical activity between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI) are reported.||5.5|-29.1|<0.05
73851355|NCT01539070|147249794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|95.0|-0.2|0.5|||Regression, Linear||The change in mean sleep time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.5|-0.2|<0.05
73901736|NCT03274999|147333564|SUPERIORITY|||||||0.157||||||Eye-opening, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.157
73901737|NCT03274999|147333564|SUPERIORITY|||||||0.111||||||Eye-opening, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.111
73901738|NCT03274999|147333564|SUPERIORITY|||||||0.04||||||Pre-blink, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.040
73901739|NCT03274999|147333564|SUPERIORITY|||||||0.241||||||Pre-blink, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.241
73901740|NCT03274999|147333564|SUPERIORITY|||||||0.284||||||Pre-blink, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.284
73901741|NCT03274999|147333564|SUPERIORITY|||||||0.313||||||Pre-blink, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.313
73901742|NCT03274999|147333564|SUPERIORITY|||||||0.433||||||Pre-blink, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.433
73901743|NCT03274999|147333564|SUPERIORITY|||||||0.406||||||Pre-blink, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.406
73901744|NCT03274999|147333564|SUPERIORITY|||||||0.318||||||Pre-blink, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.318
74088266|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.54||0.2514|TWO_SIDED|95.0|-7.97|2.11|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.11|-7.97|0.2514
73901745|NCT03274999|147333564|SUPERIORITY|||||||0.499||||||Pre-blink, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.499
73901746|NCT03274999|147333564|SUPERIORITY|||||||0.39||||||Pre-blink, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.390
73901747|NCT03274999|147333565|SUPERIORITY|||||||0.053||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.053
73901748|NCT03274999|147333565|SUPERIORITY|||||||0.206||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.206
73901749|NCT03274999|147333565|SUPERIORITY|||||||0.221||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.221
73901750|NCT03274999|147333565|SUPERIORITY|||||||0.126||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.126
73901751|NCT03274999|147333565|SUPERIORITY|||||||0.124||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.124
73901752|NCT03274999|147333565|SUPERIORITY|||||||0.167||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.167
73901753|NCT03274999|147333565|SUPERIORITY|||||||0.377||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.377
73901754|NCT03274999|147333565|SUPERIORITY|||||||0.397||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.397
73901755|NCT03274999|147333565|SUPERIORITY|||||||0.441||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.441
74024364|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.44|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.44|-1.50|<0.001
74024365|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.27||0.006|TWO_SIDED|95.0|-1.26|-0.21|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.21|-1.26|0.006
74024366|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.27||0.004|TWO_SIDED|95.0|-1.28|-0.24|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-1.28|0.004
73901756|NCT03274999|147333566|SUPERIORITY|||||||0.034||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.034
73901757|NCT03274999|147333566|SUPERIORITY|||||||0.143||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.143
73901758|NCT03274999|147333566|SUPERIORITY|||||||0.328||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
73901759|NCT03274999|147333566|SUPERIORITY|||||||0.25||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.250
73901760|NCT03274999|147333566|SUPERIORITY|||||||0.09||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
73901761|NCT03274999|147333566|SUPERIORITY|||||||0.328||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
73901762|NCT03274999|147333566|SUPERIORITY|||||||0.055||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.055
73901763|NCT03274999|147333566|SUPERIORITY|||||||0.09||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
73901764|NCT03274999|147333566|SUPERIORITY|||||||0.233||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.233
73901765|NCT03274999|147333567|SUPERIORITY|||||||0.072||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.072
73901766|NCT03274999|147333567|SUPERIORITY|||||||0.297||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.297
73901767|NCT03274999|147333567|SUPERIORITY|||||||0.328||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
73901768|NCT03274999|147333567|SUPERIORITY|||||||0.447||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.447
73901769|NCT03274999|147333567|SUPERIORITY|||||||0.328||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
73901770|NCT03274999|147333567|SUPERIORITY|||||||0.09||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
73901771|NCT03274999|147333567|SUPERIORITY|||||||0.055||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.055
73901772|NCT03274999|147333567|SUPERIORITY|||||||0.09||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
73901773|NCT03274999|147333567|SUPERIORITY|||||||0.5||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.500
74084742|NCT00452543|147722809|NON_INFERIORITY_OR_EQUIVALENCE|This was a test of non-inferiority between the effects of acamprosate vs. placebo. Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups. Results would be used to estimate effect size to set the stage for an adequately powered larger study in the future.|||||<|0.05||95.0||||Threshold for significance was set a priori at p\<0.05.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinking days.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.||||<0.05
74088267|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-6.68|STANDARD_ERROR_OF_MEAN|3.67||0.0717|TWO_SIDED|95.0|-13.97|0.6|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.60|-13.97|0.0717
73851356|NCT01539070|147249794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-4.4|1.1|||Regression, Linear||The change in mean screen time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-4.4|<0.05
73851357|NCT01539070|147249796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.05|TWO_SIDED|95.0|-0.04|0.35|||Regression, Linear|||In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.35|-0.04|<0.05
73851358|NCT02998671|147249797|SUPERIORITY|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.18|||||TWO_SIDED|90.0|0.79|1.81|||Bayesian model for repeated measurements||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value \> 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The credible interval was calculated and presented under confidence interval."|||1.81|0.79|
73851359|NCT02998671|147249797|SUPERIORITY|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.1|||||TWO_SIDED|90.0|0.66|1.8|||Bayesian model for repeated measurements||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value \> 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The credible interval was calculated and presented under confidence interval."|||1.80|0.66|
73851360|NCT02473471|147249825|OTHER|The sample size was calculated based on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups (effect size= 0.8), the power analysis yielded 28 subjects per group at a conventional alpha level (p = 0.05) and desired power (1 - β) of 0.90||||||0.77|||||||t-test, 2 sided|||||||0.77
73851361|NCT02473471|147249826|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.50
73851362|NCT02473471|147249827|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
73851363|NCT02473471|147249828|OTHER|||||||0.56|||||||t-test, 2 sided|||||||0.56
73851364|NCT02473471|147249829|OTHER|||||||0.88|||||||t-test, 2 sided|||||||0.88
73851365|NCT02473471|147249830|OTHER|||||||0.74||||||There was no significant difference in tooth movement between control and MOP sides from baseline to 1st, 2nd and 3rd months. P Value \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.74
73851366|NCT02473471|147249831|OTHER|||||||0.59|||||||t-test, 2 sided|||Root length at baseline.||||0.59
73851367|NCT02473471|147249831|OTHER|||||||0.48|||||||t-test, 2 sided|||Root length at 3 months||||0.48
73851368|NCT02473471|147249832|OTHER|||||||0.388|||||||t-test, 2 sided|||Immediate after intervention||||0.388
73851369|NCT02473471|147249832|OTHER|||||||0.092|||||||t-test, 2 sided|||1 hour after intervention||||0.092
73851370|NCT02473471|147249832|OTHER|||||||0.1|||||||t-test, 2 sided|||12 hour after intervention||||0.100
73851371|NCT02473471|147249832|OTHER|||||||0.302|||||||t-test, 2 sided|||Day 1 after intervention||||0.302
73851372|NCT02473471|147249832|OTHER|||||||0.582|||||||t-test, 2 sided|||Day 3 after intervention||||0.582
73851373|NCT02473471|147249832|OTHER|||||||0.743|||||||t-test, 2 sided|||Day 5 after intervention||||0.743
73851374|NCT02473471|147249832|OTHER|||||||0.809|||||||t-test, 2 sided|||Day 7 after intervention||||0.809
73851375|NCT02473471|147249833|OTHER|||||||0.09|||||||t-test, 2 sided|||Day 1||||0.09
73851376|NCT02473471|147249833|OTHER|||||||0.29|||||||t-test, 2 sided|||Day 3||||0.29
73851377|NCT02473471|147249833|OTHER|||||||0.57|||||||t-test, 2 sided|||Day 5||||0.57
73851378|NCT02473471|147249833|OTHER|||||||0.82|||||||t-test, 2 sided|||Day 7||||0.82
73851379|NCT02473471|147249834|OTHER|||||||0.27|||||||t-test, 2 sided|||Day 1||||0.27
73851380|NCT02473471|147249834|OTHER|||||||0.37|||||||t-test, 2 sided|||Day 3||||0.37
73851381|NCT02473471|147249834|OTHER|||||||0.33|||||||t-test, 2 sided|||Day 5||||0.33
73851382|NCT02473471|147249834|OTHER||||||>|0.05|||||||t-test, 2 sided|||Day 7||||> 0.05
73851383|NCT02473471|147249835|OTHER|||||||0.05|||||||t-test, 2 sided|||Day 1||||0.05
73851384|NCT02473471|147249835|OTHER|||||||0.47|||||||t-test, 2 sided|||Day 3||||0.47
73851385|NCT02473471|147249835|OTHER|||||||0.09|||||||t-test, 2 sided|||Day 5||||0.09
73851386|NCT02473471|147249835|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
73851387|NCT02473471|147249836|OTHER|||||||0.18|||||||t-test, 2 sided|||Day 1||||0.18
73851388|NCT02473471|147249836|OTHER|||||||0.57|||||||t-test, 2 sided|||Day 3||||0.57
73851389|NCT02473471|147249836|OTHER|||||||0.3|||||||t-test, 2 sided|||Day 5||||0.30
73851390|NCT02473471|147249836|OTHER|||||||0.56|||||||t-test, 2 sided|||Day 7||||0.56
73851391|NCT02473471|147249837|OTHER||||||<|0.05|||||||Descriptive statistics|||||||< 0.05
73901774|NCT02233946|147333574|SUPERIORITY||Cox Proportional Hazard|0.69|||||TWO_SIDED|95.0|0.47|1.02||||||Participants who reported past-12-month use of alcohol or other drugs at baseline||1.02|0.47|
73901775|NCT02233946|147333574|SUPERIORITY||Cox Proportional Hazard|0.87|||||TWO_SIDED|95.0|0.57|1.31||||||Participants who reported no past-12-month use of alcohol or other drugs at baseline||1.31|0.57|
73901776|NCT02233946|147333575|SUPERIORITY||Cox Proportional Hazard|0.66|||||TWO_SIDED|95.0|0.4|1.1||||||Participants who reported past-12-month use of alcohol or other drugs at baseline||1.10|0.40|
73901777|NCT02233946|147333576|SUPERIORITY|Participants who reported past-12-month use of alcohol or other drugs at baseline|Cox Proportional Hazard|0.62|||||TWO_SIDED|95.0|0.41|0.94||||||||0.94|0.41|
73901778|NCT02233946|147333576|SUPERIORITY||Cox Proportional Hazard|0.76|||||TWO_SIDED|95.0|0.44|1.32||||||Participants who reported no past-12-month use of alcohol or other drugs at baseline||1.32|0.44|
73901779|NCT02233946|147333577|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.5|1.34||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU."||1.34|0.50|
73901780|NCT02233946|147333577|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.44|1.19||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU."||1.19|0.44|
73901781|NCT02233946|147333577|SUPERIORITY||Risk Ratio (RR)|0.58|||||TWO_SIDED|95.0|0.37|0.91||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU."||0.91|0.37|
73901782|NCT02233946|147333577|SUPERIORITY||Risk Ratio (RR)|0.72|||||TWO_SIDED|95.0|0.43|1.23||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU."||1.23|0.43|
73901783|NCT02233946|147333577|SUPERIORITY||Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|0.67|2.66||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU."||2.66|0.67|
73901784|NCT02233946|147333577|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.5|1.99||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU."||1.99|0.50|
73901785|NCT03493815|147333601|SUPERIORITY||Risk Ratio (RR)|0.73||||0.51|TWO_SIDED|95.0|0.28|1.9|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.|||1.90|0.28|0.51
73901786|NCT03493815|147333602|SUPERIORITY||Risk Ratio (RR)|0.58||||0.41|TWO_SIDED|95.0|0.15|2.18|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.|||2.18|0.15|0.41
73901787|NCT03493815|147333603|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
73901788|NCT03493815|147333604|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
73901789|NCT01842633|147333610|SUPERIORITY_OR_OTHER||Treatment Difference|-0.47|||||TWO_SIDED|95.0|-1.36|0.42||||||||0.42|-1.36|
73901790|NCT02093351|147333624|EQUIVALENCE|If the 90% confidence interval (CI) for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.13|||||TWO_SIDED|90.0|1.06|1.22|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.||1.22|1.06|
73901791|NCT02093351|147333625|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.8|||||TWO_SIDED|90.0|0.71|0.9|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.||0.90|0.71|
73901792|NCT02093351|147333626|EQUIVALENCE|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|Geometric Least Squares (GLS) Mean Ratio|0.9|||||TWO_SIDED|90.0|0.84|0.97|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.||0.97|0.84|
73901793|NCT02093351|147333627|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.84|1.04|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.||1.04|0.84|
73901794|NCT02093351|147333628|EQUIVALENCE|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.91|0.98|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.||0.98|0.91|
74024367|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.91|-0.86|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.86|-1.91|<0.001
73901795|NCT02093351|147333629|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.99|1.21|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters||1.21|0.99|
73901796|NCT02093351|147333630|EQUIVALENCE|If the 90% CI for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.16|||||TWO_SIDED|90.0|1.11|1.21|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.||1.21|1.11|
73901797|NCT02093351|147333631|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.73|||||TWO_SIDED|90.0|0.63|0.84|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.||0.84|0.63|
73901798|NCT02093351|147333632|EQUIVALENCE|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|GLS Mean Ratio|0.86|||||TWO_SIDED|90.0|0.8|0.93|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.||0.93|0.80|
73901799|NCT02093351|147333633|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.89|||||TWO_SIDED|90.0|0.76|1.05|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.||1.05|0.76|
73851392|NCT01625416|147249905|SUPERIORITY|||||||0.05|||||||Chi-squared|Chi square (2) =5.9, p=0.05|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.05
73851393|NCT01625416|147249906|SUPERIORITY|||||||0.69|||||||Chi-squared|Chi square(2) = 0.74, p = 0.69|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.69
73851394|NCT01625416|147249909|SUPERIORITY|||||||0.97||||||Chi square (2) = 0.06, p = 0.97|Chi-squared||||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.97
73851395|NCT01625416|147249910|SUPERIORITY|||||||0.71|||||||Chi-squared|Chi-Square (2) =0.68, p=0.71|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.71
73851396|NCT03980743|147249932|SUPERIORITY|||||||0.97|||||||Mixed Models Analysis|||Time x treatment (week 0 and week 24)||||0.97
73851397|NCT03980743|147249933|SUPERIORITY|||||||0.273|||||||Mixed Models Analysis|||Time x treatment (week 0 and week 24) for Healthy Eating||||0.273
73851398|NCT03980743|147249934|SUPERIORITY|Time x treatment (week 0 and week 24) with sum score||||||0.691|||||||Mixed Models Analysis|||||||0.691
73851399|NCT00294671|147249935|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 2 years.||||<0.001
73851400|NCT00294671|147249935|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 1years.||||0.02
73851401|NCT00294671|147249936|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 2 years.||||0.002
73851402|NCT00294671|147249936|SUPERIORITY_OR_OTHER|||||||0.1|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 1 year.||||0.10
73851403|NCT00294671|147249937|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 2 years.||||0.21
73851404|NCT00294671|147249937|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 1 year.||||0.43
74084743|NCT00452543|147722810|NON_INFERIORITY_OR_EQUIVALENCE|This was a test of non-inferiority between the effects of acamprosate vs. placebo.|||||<|0.05||95.0||||This p \<0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per week.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.||||<0.05
73851405|NCT00294671|147249938|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 2 years.||||0.001
73851406|NCT00294671|147249938|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 1 year.||||0.06
73851407|NCT00294671|147249939|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 2 years.||||0.06
73851408|NCT00294671|147249939|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 1 year.||||0.37
73851409|NCT02263326|147249950|NON_INFERIORITY|We considered DTG/3TC was noninferior to cART if the 90% confidence interval for the difference in proportions, calculated with Miettinen-Nurminen (score) confidence limits, excluded the 12% noninferiority margin.|Risk Difference (RD)|0.0015|||||TWO_SIDED|90.0|-0.098|0.102||||||A sample size of 41 participants per arm provided 80% power to show noninferiority of DTG/3TC to cART based on a 12% noninferiority margin, assuming an estimated treatment failure rate of 5% per arm by week 24 and 5% 1-sided type I error rate.||0.102|-0.098|
73851410|NCT02263326|147249951|NON_INFERIORITY|The difference in virologic outcomes based on the FDA snapshot algorithm at week 48 (HIV RNA \<50 copies/mL) was compared between arms, with 95% confidence intervals.|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.126|0.165||||||||0.165|-0.126|
73851411|NCT02263326|147249952|OTHER|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
73851412|NCT02263326|147249953|OTHER|||||||0.613|||||||Wilcoxon (Mann-Whitney)|||||||0.613
73851413|NCT02263326|147249954|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
73851414|NCT02263326|147249955|OTHER|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
73851415|NCT02263326|147249957|OTHER||Mean Difference (Final Values)|0.5||||0.76|TWO_SIDED|95.0|-3.0|4.1|||Regression, Linear|||||4.1|-3.0|0.76
73851416|NCT01893411|147249958|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean difference|-0.04|||=|0.65|TWO_SIDED|95.0|-0.23|0.14|||Mixed Model Repeated Measure|||||0.14|-0.23|= 0.65
73851417|NCT01893411|147249958|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|-0.04|||=|0.741|TWO_SIDED|95.0|-0.26|0.18|||Mixed Model Repeated Measure|||||0.18|-0.26|= 0.741
73851418|NCT01893411|147249959|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|0.16|||=|0.075|TWO_SIDED|95.0|-0.02|0.34|||Mixed Model Repeated Measure|||||0.34|-0.02|= 0.075
73851419|NCT01893411|147249959|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|0.06|||=|0.603|TWO_SIDED|95.0|-0.16|0.27|||Mixed Model Repeated Measure|||||0.27|-0.16|= 0.603
73851420|NCT02397915|147249977|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
73851421|NCT02397915|147249978|SUPERIORITY_OR_OTHER|||||||0.065||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute scent/odor.|Cochran-Mantel-Haenszel|||||||0.065
73901800|NCT02093351|147333634|EQUIVALENCE|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.95|||||TWO_SIDED|90.0|0.91|0.99|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.||0.99|0.91|
73961843|NCT01068743|147460378|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.17|||||TWO_SIDED|90.0|96.23|102.21|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||102.21|96.23|
73961844|NCT01068743|147460378|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11998.0||||||||||||||Geometric least squares mean for Treatment A.||||
73961845|NCT01068743|147460378|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|12250.0||||||||||||||Geometric least squares means for Treatment B.||||
73961846|NCT01068743|147460378|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|12036.0||||||||||||||Geometric least squares means for Treatment C.||||
73961847|NCT01068743|147460378|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11937.0||||||||||||||Geometric least squares means for Treatment D.||||
74024368|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.43|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.43|-1.50|<0.001
73851422|NCT02397915|147249978|SUPERIORITY_OR_OTHER|||||||0.532||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute immediate taste.|Cochran-Mantel-Haenszel|||||||0.532
73901801|NCT02093351|147333635|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.15|||||TWO_SIDED|90.0|1.07|1.25|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters.||1.25|1.07|
73901802|NCT01099709|147333636|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|105.0|||||TWO_SIDED|90.0|101.06|108.51|||||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||108.51|101.06|
73901803|NCT01099709|147333636|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|105.0|||||TWO_SIDED|90.0|101.06|108.51|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||108.51|101.06|
73901804|NCT01099709|147333637|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.6|||||TWO_SIDED|90.0|93.73|97.53|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.53|93.73|
73851423|NCT02397915|147249978|SUPERIORITY_OR_OTHER|||||||0.138||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute after taste.|Cochran-Mantel-Haenszel|||||||0.138
73851424|NCT02397915|147249978|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute LDTT.|Cochran-Mantel-Haenszel|||||||<0.001
73901805|NCT01099709|147333638|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric test/Ref Ratio x 100|95.7|||||TWO_SIDED|90.0|93.85|97.68|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.68|93.85|
73901806|NCT01555957|147333643|SUPERIORITY|||||||0.94|||||||Chi-squared|||we hypothesized that among ≥ 34 weeks GA infants with GISDs, infants receiving 1g/kg/day S-ILE (lipid minimizing strategy) would have decreased incidence of IFALD compared to those receiving 2g/kg/day S-ILE. We also hypothesized that the rate of rise of DB would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.||||0.94
73901807|NCT01555957|147333644|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||We also hypothesized that the rate of rise of direct bilirubin would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.||||0.0005
73901808|NCT00718081|147333645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.48|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|ONE_SIDED|95.0|||||ANCOVA|||||||<0.001
73901809|NCT00718081|147333645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.62|STANDARD_ERROR_OF_MEAN|4.86|<|0.001|ONE_SIDED|95.0|||||ANCOVA|||||||<0.001
73901810|NCT01545843|147333688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||Mixed Models Analysis|||||||.202
73901811|NCT01993836|147333713|OTHER||Spearman Correlation|-0.03|||||TWO_SIDED|95.0|-0.23|0.18||||||Correlation between 6-week change in Tau and continuous cognitive index||0.18|-0.23|
73961848|NCT01068743|147460379|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.5|||||TWO_SIDED|90.0|90.41|109.5|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||109.5|90.41|
73851425|NCT02397915|147249978|SUPERIORITY_OR_OTHER|||||||0.017||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute LRON.|Cochran-Mantel-Haenszel|||||||0.017
73851426|NCT02397915|147249978|SUPERIORITY_OR_OTHER|||||||0.046||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute more soothing.|Cochran-Mantel-Haenszel|||||||0.046
73851427|NCT02397915|147249978|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute less irritating.|Cochran-Mantel-Haenszel|||||||<0.001
73851428|NCT02397915|147249978|SUPERIORITY_OR_OTHER|||||||0.532||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute UTS.|Cochran-Mantel-Haenszel|||||||0.532
73851429|NCT02397915|147249979|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.000
73851430|NCT02397915|147249980|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
73851431|NCT02397915|147249981|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
73851432|NCT02397915|147249982|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.179||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.179
73851433|NCT02397915|147249983|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
73851434|NCT02397915|147249984|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
73851435|NCT02397915|147249985|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
73851436|NCT02397915|147249986|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.000
73851437|NCT02397915|147249987|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.188||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.188
73851438|NCT02397915|147249988|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
73851439|NCT02397915|147249989|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
73851440|NCT02397915|147249990|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
73851441|NCT02397915|147249991|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.004||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.004
73901812|NCT01993836|147333713|OTHER||Spearman Correlation|-0.08|||||TWO_SIDED|95.0|-0.29|0.13||||||Correlation between 6-week change in Abeta and continuous cognitive index||0.13|-0.29|
73901813|NCT01993836|147333713|OTHER||Spearman Correlation|0.12|||||TWO_SIDED|95.0|-0.08|0.32||||||Correlation between 6-week change in P-Tau and continuous cognitive index||0.32|-0.08|
73851442|NCT02397915|147249992|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.223||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.223
73851443|NCT02397915|147249993|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
73901814|NCT01993836|147333714|OTHER||Spearman Correlation|0.02|||||TWO_SIDED|95.0|-0.19|0.22||||||Correlation between 6-week change in Tau/Abeta ratio and continuous cognitive index||0.22|-0.19|
73901815|NCT01993836|147333714|OTHER||Spearman Correlation|0.16|||||TWO_SIDED|95.0|-0.05|0.34||||||Correlation between 6-week change in P-Tau/Abeta ratio and continuous cognitive index||0.34|-0.05|
73851444|NCT02397915|147249994|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.008||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.008
73851445|NCT02397915|147249995|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.831||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.831
73851446|NCT02397915|147249996|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
73851447|NCT02397915|147249997|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.007||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.007
73851448|NCT02397915|147249998|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.568||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.568
73851449|NCT02397915|147249999|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
73851450|NCT03292874|147250001|SUPERIORITY|||||||0.014||||||"Areas under the receiver operating characteristics curve (AUC) were compared between models with standard and high-resolution MRI variables using the nonparametric method described by DeLong.~DeLong. Biometrics 1988;44(3):837-45."|nonparametric method|||||||0.014
73851451|NCT03053440|147250028|SUPERIORITY||Risk Difference (RD)|10.2||||0.0921|TWO_SIDED|95.0|-1.5|22.0|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by the stratification factors per interactive response technology (IRT). p value is 2-sided||||22.0|-1.5|0.0921
73851452|NCT01771991|147250144|SUPERIORITY||sum of scores|453.0|STANDARD_DEVIATION|39.6||0.57|TWO_SIDED||||||Wilcoxon Rank-Sum||Standard Deviation under the Null hypothesis for each group.|||||0.57
73851453|NCT01771991|147250145|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|1.5||0.65|TWO_SIDED|95.0|-0.6|0.95|||t-test, 2 sided|||Looking at the difference in pain change over time. The null hypothesis is there was no difference between the two treatment groups.||0.95|-0.60|0.65
73851454|NCT01771991|147250146|SUPERIORITY||Mean Difference (Final Values)|2.63|STANDARD_DEVIATION|17.79||0.57|TWO_SIDED|95.0|-6.65|11.91|||t-test, 2 sided|||Looking at the difference in range of motion change over time. The null hypothesis is there was no difference between the two treatment groups.||11.91|-6.65|0.57
73851455|NCT01399229|147250147|NON_INFERIORITY_OR_EQUIVALENCE|"Agreement between SureCALL® and Tocodynamometer Contraction Peak Times~Null hypothesis: The mean peak difference between RMS and TOCO is equal to 0. Alternative hypothesis: The mean peak difference is not equal to 0."|Mean Difference (Net)|0.99|STANDARD_ERROR_OF_MEAN|1.4086||0.4901|TWO_SIDED|95.0|-28.74|30.72|||Mixed Models Analysis|||||30.72|-28.74|0.4901
73851456|NCT02526212|147250158|SUPERIORITY|||||||0.44|||||||Fisher Exact|||Due to the small sample size, planned analyses that assessed for clustering by group assignment or primary care physician could not be conducted. Chi square using fisher's exact test was conducted to investigate differences in abstinence between study arms.||||0.44
73851457|NCT02526212|147250161|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Each of the 17 items were rated on a scale from 1 to 5. For each participant, the scores from these items were summed and divided by 17 for an average satisfaction score. The average satisfaction score was compared between study arms.||||0.20
73901816|NCT01993836|147333715|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.360
73901817|NCT01993836|147333716|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau Change between anesthetic groups||||0.532
73901818|NCT01993836|147333716|OTHER|||||||0.565|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Abeta Change between anesthetic groups||||0.565
73901819|NCT01993836|147333716|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau Change between anesthetic groups||||0.110
73901820|NCT01993836|147333717|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau/Abeta ratio Change between anesthetic groups||||0.439
73851458|NCT03645096|147250164|SUPERIORITY||Mean Difference (Final Values)|0.0493|STANDARD_ERROR_OF_MEAN|0.0554||0.195|TWO_SIDED|95.0|-0.0703|0.1689||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Amygdala-PCC functional connectivity (z-score) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Amygdala-PCC functional connectivity (z-score) at 500 mg will be greater than that at placebo."||0.1689|-0.0703|.195
73851459|NCT03645096|147250164|SUPERIORITY||Mean Difference (Final Values)|0.0262|STANDARD_ERROR_OF_MEAN|0.0565||0.325|TWO_SIDED|95.0|-0.0943|0.1467||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Amygdala-PCC functional connectivity (z-score) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Amygdala-PCC functional connectivity (z-score) at 800 mg will be greater than that at placebo."||0.1467|-0.0943|.325
73901821|NCT01993836|147333717|OTHER|||||||0.082|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau/Abeta Change between anesthetic groups||||0.082
73901822|NCT01993836|147333718|OTHER|||||||0.801|||||||Wilcoxon Signed Rank|||||||0.801
73901823|NCT04369924|147333731|SUPERIORITY||F test for time by condition interaction|1.49||||0.25|TWO_SIDED||||||ANOVA|||||||.25
73901824|NCT04369924|147333732|SUPERIORITY||F test for time by condition interaction|2.8||||0.12|TWO_SIDED||||||ANOVA|||||||.12
73901825|NCT04369924|147333733|SUPERIORITY||F test for time by condition interaction|0.7||||0.7|TWO_SIDED||||||ANOVA|||||||.70
73901826|NCT04369924|147333734|SUPERIORITY||F test for time by condition interaction|3.67||||0.07|TWO_SIDED||||||ANOVA|||||||.07
73901827|NCT04369924|147333735|SUPERIORITY||Slope|0.16||||0.82|TWO_SIDED||||||Mixed Models Analysis|||||||.82
73901828|NCT04369924|147333736|SUPERIORITY||Slope|-2.41||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||.59
73901829|NCT02106923|147333750|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.98|STANDARD_ERROR_OF_MEAN|1.014|<|0.0001|TWO_SIDED|90.0|100.505|105.514|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||105.514|100.505|<0.0001
73901830|NCT02106923|147333750|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.25|STANDARD_ERROR_OF_MEAN|1.021|<|0.0001|TWO_SIDED|90.0|96.809|103.823|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||103.823|96.809|<0.0001
73851460|NCT03645096|147250165|SUPERIORITY||Mean Difference (Final Values)|-0.0071|STANDARD_ERROR_OF_MEAN|0.0878||0.468|TWO_SIDED|95.0|-0.1969|0.1827||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: dlPFC-Insula functional connectivity (z-score) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: dlPFC-Insula functional connectivity (z-score) at 500 mg will be greater than that at placebo."||0.1827|-0.1969|.468
73851461|NCT03645096|147250165|SUPERIORITY||Mean Difference (Final Values)|0.0097|STANDARD_ERROR_OF_MEAN|0.0891||0.458|TWO_SIDED|95.0|-0.1803|0.1996||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: dlPFC-Insula functional connectivity (z-score) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: dlPFC-Insula functional connectivity (z-score) at 800 mg will be greater than that at placebo."||0.1996|-0.1803|.458
73851462|NCT03645096|147250166|SUPERIORITY||Mean Difference (Final Values)|0.0038|STANDARD_ERROR_OF_MEAN|0.0078||0.316|TWO_SIDED|95.0|-0.0132|0.0209||Paired samples t-test with corrected standard deviation of the difference.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: GABA concentration (mM) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: GABA concentration (mM) at 500 mg will be greater than that at placebo."||0.0209|-0.0132|.316
73851463|NCT03645096|147250166|SUPERIORITY||Mean Difference (Final Values)|0.0131|STANDARD_ERROR_OF_MEAN|0.0084||0.071|TWO_SIDED|95.0|-0.005|0.0312||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: GABA concentration (mM) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: GABA concentration (mM) at 500 mg will be greater than that at placebo."||0.0312|-0.0050|.071
73851464|NCT03645096|147250167|SUPERIORITY||Mean Difference (Final Values)|-11322.45|STANDARD_ERROR_OF_MEAN|3750.52||0.006|TWO_SIDED|95.0|-19577.27|-3067.62||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Pregnenolone level (pg/mL) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Pregnenolone level (pg/mL) at 500 mg will be greater than that at placebo."||-3067.62|-19577.27|.006
73851465|NCT03645096|147250167|SUPERIORITY||Mean Difference (Final Values)|-11828.78|STANDARD_ERROR_OF_MEAN|3620.42||0.003|TWO_SIDED|95.0|-19650.24|-4007.33||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Pregnenolone level (pg/mL) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Pregnenolone level (pg/mL) at 800 mg will be greater than that at placebo."||-4007.33|-19650.24|.003
73851466|NCT03645096|147250168|SUPERIORITY||Mean Difference (Final Values)|-2523.58|STANDARD_ERROR_OF_MEAN|545.83||0.001|TWO_SIDED|95.0|-3724.93|-1322.22||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Allopregnanolone level (pg/mL) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Allopregnanolone level (pg/mL) at 500 mg will be greater than that at placebo."||-1322.22|-3724.93|.001
73901831|NCT02106923|147333750|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.08|STANDARD_ERROR_OF_MEAN|1.016|<|0.0001|TWO_SIDED|90.0|93.507|98.721|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||98.721|93.507|<0.0001
73901832|NCT02106923|147333751|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.04|STANDARD_ERROR_OF_MEAN|1.06||0.0011|TWO_SIDED|90.0|92.3|112.81|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||112.81|92.30|0.0011
73901833|NCT02106923|147333751|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.93|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|90.0|95.45|102.53|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||102.53|95.45|<0.0001
74024369|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.27||0.005|TWO_SIDED|95.0|-1.3|-0.23|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.23|-1.30|0.005
74024370|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.75|-0.69|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.69|-1.75|<0.001
74024371|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.28||0.061|TWO_SIDED|95.0|-1.07|0.02|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.02|-1.07|0.061
73851467|NCT03645096|147250168|SUPERIORITY||Mean Difference (Final Values)|-2480.62|STANDARD_ERROR_OF_MEAN|582.63||0.001|TWO_SIDED|95.0|-3739.32|-1221.93||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Allopregnanolone level (pg/mL) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Allopregnanolone level (pg/mL) at 800 mg will be greater than that at placebo."||-1221.93|-3739.32|.001
73851468|NCT03645096|147250169|NON_INFERIORITY|"Using the two one-sided test (TOST) procedure (Schuirmann, 1987), equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies (new - current) is contained within the interval (-δ, δ)~Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of pharmacokinetics and biopharmaceutics, 15, 657-680."|Mean Difference (Final Values)|0.7059|STANDARD_ERROR_OF_MEAN|1.6377||0.336|TWO_SIDED|95.0|-2.7659|4.1777||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: SAFTEE (total) scores at 500 mg will be greater than or equal to that at placebo.~Alternative Hypothesis: SAFTEE (total) scores at 500 mg will be less than that at placebo."||4.1777|-2.7659|.336
73851469|NCT03645096|147250169|NON_INFERIORITY|"Using the two one-sided test (TOST) procedure (Schuirmann, 1987), equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies (new - current) is contained within the interval (-δ, δ)~Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of pharmacokinetics and biopharmaceutics, 15, 657-680."|Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|3.4662||0.24|TWO_SIDED|95.0|-9.8131|4.8131||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: SAFTEE (total) scores at 800 mg will be greater than or equal to that at placebo.~Alternative Hypothesis: SAFTEE (total) scores at 800 mg will be less than that at placebo."||4.8131|-9.8131|.240
73851470|NCT00040742|147250171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.566|STANDARD_ERROR_OF_MEAN|0.145||0.017|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||.017
73851471|NCT00040742|147250171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.506|STANDARD_ERROR_OF_MEAN|0.141||0.036|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.036
73851472|NCT00040742|147250171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.269|STANDARD_ERROR_OF_MEAN|0.137||0.431|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.431
73901834|NCT02106923|147333751|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.7|STANDARD_ERROR_OF_MEAN|1.05||0.0002|TWO_SIDED|90.0|93.59|110.52|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||110.52|93.59|0.0002
73901835|NCT02106923|147333752|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.88|STANDARD_ERROR_OF_MEAN|1.014|<|0.0001|TWO_SIDED|90.0|100.446|105.373|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||105.373|100.446|<0.0001
73901836|NCT02106923|147333752|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.03|STANDARD_ERROR_OF_MEAN|1.021|<|0.0001|TWO_SIDED|90.0|96.448|103.738|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||103.738|96.448|<0.0001
73901837|NCT02106923|147333752|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.49|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|93.758|99.311|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||99.311|93.758|<0.0001
74024372|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.021|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-1.20|0.021
74024373|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.85|-0.76|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.76|-1.85|<0.001
74024374|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.166|TWO_SIDED|95.0|-0.95|0.16|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.16|-0.95|0.166
73901838|NCT02106923|147333753|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|104.83|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.522|110.412|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||110.412|99.522|<0.0001
73901839|NCT02106923|147333753|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.84|STANDARD_ERROR_OF_MEAN|1.041|<|0.0001|TWO_SIDED|90.0|95.03|109.134|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||109.134|95.030|<0.0001
73901840|NCT02106923|147333753|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.03|STANDARD_ERROR_OF_MEAN|1.037|<|0.0001|TWO_SIDED|90.0|90.217|102.211|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||102.211|90.217|<0.0001
73901841|NCT02106923|147333754|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.94|STANDARD_DEVIATION|1.071||0.0027|TWO_SIDED|90.0|87.925|111.329|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||111.329|87.925|0.0027
73901842|NCT02106923|147333754|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|108.18|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|102.792|113.859|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||113.859|102.792|<0.0001
73901843|NCT02106923|147333754|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.62|STANDARD_ERROR_OF_MEAN|1.071||0.006|TWO_SIDED|90.0|92.116|116.559|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||116.559|92.116|0.0060
73901844|NCT02106923|147333755|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.33|STANDARD_ERROR_OF_MEAN|1.06||0.0008|TWO_SIDED|90.0|89.13|108.47|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||108.47|89.13|0.0008
73901845|NCT02106923|147333755|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.71|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|90.0|94.77|102.8|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||102.80|94.77|<0.0001
73901846|NCT02106923|147333755|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.9|STANDARD_ERROR_OF_MEAN|1.06||0.0021|TWO_SIDED|90.0|94.09|114.74|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||114.74|94.09|0.0021
73901847|NCT03485495|147333756|SUPERIORITY|||||||0.007||||||A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.|t-test, 2 sided|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.007
73901848|NCT03485495|147333757|SUPERIORITY|||||||0.0272||||||A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.|Fisher Exact|||||||0.0272
73901849|NCT03485495|147333758|SUPERIORITY|||||||0.8762|||||||t-test, 2 sided|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.8762
73901850|NCT03485495|147333759|SUPERIORITY|||||||0.2082|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.2082
73901851|NCT03485495|147333760|SUPERIORITY|||||||0.0038||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO-3 data.||||0.0038
73901852|NCT03485495|147333760|SUPERIORITY|||||||0.0018||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO-2 data.||||0.0018
73901853|NCT03485495|147333760|SUPERIORITY|||||||0.46||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO data.||||0.46
73901854|NCT03485495|147333761|SUPERIORITY|||||||0.88||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to ADP-PA data.||||0.88
73901855|NCT03485495|147333761|SUPERIORITY|||||||0.93||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to ADR-PA data.||||0.93
73901856|NCT00773838|147333817|OTHER|||||||0.419|||||||Exact Test for Binomial Parameter|||||||0.419
73901857|NCT02502006|147333831|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73901858|NCT02502006|147333832|SUPERIORITY|||||||0.0004|||||||ANOVA|||||||0.0004
73901859|NCT02502006|147333833|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73901860|NCT02502006|147333834|SUPERIORITY|||||||0.2217|||||||ANOVA|||||||0.2217
73901861|NCT02502006|147333835|SUPERIORITY|||||||0.77||||||Adjusted for multiple comparisons|ANOVA|||||||0.77
74084744|NCT00452543|147722811|NON_INFERIORITY_OR_EQUIVALENCE|"This was a test of non-inferiority between the effects of acamprosate vs. placebo. Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis is discussed above."|||||<|0.05||95.0||||This p\<0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||"Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups."||||<0.05
73901862|NCT02502006|147333835|SUPERIORITY|||||||0.18||||||Adjusted for multiple comparisons|ANOVA|||||||0.18
73901863|NCT02502006|147333836|SUPERIORITY|||||||0.57||||||Adjusted for multiple comparisons|ANOVA|||||||0.57
74024375|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.167|TWO_SIDED|95.0|-0.95|0.16|||ANOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.16|-0.95|0.167
74024376|NCT00733902|147600901|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.75|-0.64|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.64|-1.75|<0.001
74024377|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.27||0.044|TWO_SIDED|95.0|-1.07|-0.02|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-1.07|0.044
74024378|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.875|TWO_SIDED|95.0|-0.57|0.48|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.48|-0.57|0.875
73851473|NCT00040742|147250171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.16||0.003|TWO_SIDED||||||Mixed Models Analysis|Parameter estimated using a contrast.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs. Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.003
73851474|NCT00040742|147250172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.441|STANDARD_ERROR_OF_MEAN|0.127||0.046|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.046
73851475|NCT00040742|147250172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.124||0.076|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.076
73851476|NCT00040742|147250172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.12||0.738|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.738
73851477|NCT00040742|147250172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.14||0.013|TWO_SIDED||||||Mixed Models Analysis|Contrasts used for estimation.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.013
73851478|NCT00405392|147250195|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73851479|NCT00405392|147250196|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73851480|NCT00405392|147250197|SUPERIORITY_OR_OTHER|||||||0.9456|||||||t-test, 2 sided|||||||0.9456
73851481|NCT00412958|147250198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.796|TWO_SIDED|95.0|0.24|6.36|||Regression, Logistic|||P-values are from Wald chi-square tests from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||6.36|0.24|0.796
73901864|NCT02502006|147333836|SUPERIORITY|||||||0.07||||||Adjusted for multiple comparisons|ANOVA|||||||0.07
73901865|NCT02502006|147333837|SUPERIORITY|||||||0.88||||||Adjusted for multiple comparisons|ANOVA|||||||0.88
73901866|NCT02502006|147333837|SUPERIORITY||||||<|0.05||||||Adjusted for multiple comparisons|ANOVA|||||||<0.05
74024379|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.129|TWO_SIDED|95.0|-0.93|0.12|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.12|-0.93|0.129
73901867|NCT00509262|147333849|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus glipizide) to be less than 0.4%.|Difference in least squares mean|-0.11|STANDARD_DEVIATION|0.74|||TWO_SIDED|95.0|-0.29|0.06|||ANCOVA||Based on analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate, or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline A1C.|||0.06|-0.29|
73901868|NCT00509262|147333850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8||||0.001|TWO_SIDED|95.0|-17.1|-4.8|||Miettirnen& Nurminen method||Miettirnen \& Nurminen method stratified by renal insufficiency stratum at Visit 4/Week -2 (moderate or severe) \& prior diabetes pharmacotherapy|||-4.8|-17.1|0.001
73901869|NCT00509262|147333851|SUPERIORITY_OR_OTHER||Difference in least squares mean|7.1|STANDARD_DEVIATION|38.3|||TWO_SIDED|95.0|-1.9|16.1|||ANCOVA||Analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline Fasting Plasma Glucose.|||16.1|-1.9|
73901870|NCT00509262|147333852|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.8|STANDARD_DEVIATION|3.8|<|0.001|TWO_SIDED|95.0|-2.6|-1.0|||ANCOVA||Analysis of covariance with terms of treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline body weight.|||-1.0|-2.6|<0.001
73901871|NCT00997113|147333858|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of the change in serum catecholamines from one minute before the procedure to one minute after. In order to detect a 20% difference in mean catecholamine values between groups, assuming a 30% standard deviation, with an alpha of 0.05 and a beta of 0.2 (80% power), power analysis indicated that 10 patients per group were required.||||0.940
73901872|NCT02674854|147333887|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil||||||<0.0001
73901873|NCT02674854|147333887|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost||||||<0.0001
73901874|NCT02889562|147333902|OTHER|Pearson chi-squared tests or Fisher exact tests||||||1|||||||Chi-squared|||||||1.0
73901875|NCT02889562|147333905|OTHER|t-test and Wilcoxon analysis||||||0.17|||||||t-test, 1 sided|||||||0.17
73901876|NCT01943474|147333907|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
73901877|NCT01943474|147333908|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
73901878|NCT01943474|147333909|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
73901879|NCT01943474|147333910|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73901880|NCT01943474|147333911|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73901881|NCT01943474|147333914|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73901882|NCT01943474|147333915|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73901883|NCT05985980|147333925|EQUIVALENCE|The null hypothesis is true that the ST/HR index (μV/bpm) ıs similar between the early and late follicular phases||||||0.521|||||||t-test, 2 sided|||||||0.521
74024380|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.51|-0.45|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.45|-1.51|<0.001
73901884|NCT05985980|147333926|EQUIVALENCE|High-sensitive cardiac troponin T (hs-cTnT) levels before and after ETT at the early and late follicular phases are compared.||||||0.109|||||||ANOVA|||High-sensitive cardiac troponin T (hs-cTnT) levels before and after ETT at the early and late follicular phases are compared.||||0.109
73901885|NCT05985980|147333927|EQUIVALENCE|ETT maximal exercise capacity (METs score) is compared between the early and late follicular phases of menstrual cycle||||||0.111|||||||t-test, 2 sided|||ETT maximal exercise capacity (METs score) is compared between the early and late follicular phases of menstrual cycle||||0.111
73901886|NCT05985980|147333928|EQUIVALENCE|ETT ST/HR slope (μV/bpm) is compared between the early and late follicular phases of menstrual cycle||||||0.414|||||||t-test, 2 sided|||ETT ST/HR slope (μV/bpm) is compared between the early and late follicular phases of menstrual cycle||||0.414
73901887|NCT05985980|147333929|EQUIVALENCE|Maximal horizontal or down slope ST segment depression (mm) during exercise treadmill test is compared between the early and late follicular phases of menstrual cycle||||||0.062|||||||t-test, 2 sided|||Maximal horizontal or down slope ST segment depression (mm) during exercise treadmill test is compared between the early and late follicular phases of menstrual cycle||||0.062
73901888|NCT05985980|147333930|EQUIVALENCE|Estrogen levels increase at the late follicular phase.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73901889|NCT04445792|147333934|SUPERIORITY|||||||0.7195|||||||Wilcoxon (Mann-Whitney)|||||||0.7195
73901890|NCT04445792|147333934|SUPERIORITY|||||||0.8054|||||||Wilcoxon (Mann-Whitney)|||||||0.8054
73901891|NCT04445792|147333934|SUPERIORITY|||||||0.861|||||||Wilcoxon (Mann-Whitney)|||||||0.861
73901892|NCT04445792|147333935|SUPERIORITY|||||||0.4385|||||||Wilcoxon (Mann-Whitney)|||||||0.4385
73901893|NCT04445792|147333935|SUPERIORITY|||||||0.7185|||||||Wilcoxon (Mann-Whitney)|||||||0.7185
73901894|NCT04445792|147333935|SUPERIORITY|||||||0.431|||||||Wilcoxon (Mann-Whitney)|||||||0.431
73901895|NCT04445792|147333936|SUPERIORITY|||||||0.9222|||||||Wilcoxon (Mann-Whitney)|||||||0.9222
73901896|NCT04445792|147333936|SUPERIORITY|||||||0.1918|||||||Wilcoxon (Mann-Whitney)|||||||0.1918
73901897|NCT04445792|147333936|SUPERIORITY|||||||0.0119|||||||Wilcoxon (Mann-Whitney)|||||||0.0119
73901898|NCT04445792|147333937|SUPERIORITY|||||||0.6971|||||||Wilcoxon (Mann-Whitney)|||||||0.6971
73901899|NCT04445792|147333937|SUPERIORITY|||||||0.2309|||||||Wilcoxon (Mann-Whitney)|||||||0.2309
73901900|NCT04445792|147333937|SUPERIORITY|||||||0.0441|||||||Wilcoxon (Mann-Whitney)|||||||0.0441
73901901|NCT04445792|147333938|SUPERIORITY|||||||0.7988|||||||Wilcoxon (Mann-Whitney)|||||||0.7988
73901902|NCT04445792|147333938|SUPERIORITY|||||||0.0483|||||||Wilcoxon (Mann-Whitney)|||||||0.0483
73901903|NCT04445792|147333938|SUPERIORITY|||||||0.0104|||||||Wilcoxon (Mann-Whitney)|||||||0.0104
73901904|NCT04445792|147333939|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
73901905|NCT04445792|147333939|SUPERIORITY|||||||0.2348|||||||Wilcoxon (Mann-Whitney)|||||||0.2348
74024381|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.38|-0.32|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.38|0.002
73851482|NCT00412958|147250198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.447|TWO_SIDED|95.0|0.39|8.36|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||8.36|0.39|0.447
73851483|NCT00412958|147250198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28||||0.107|TWO_SIDED|95.0|0.77|13.95|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||13.95|0.77|0.107
73851484|NCT04904744|147250212|SUPERIORITY||Odds Ratio (OR)|1.35||||0.165|TWO_SIDED|95.0|0.88|2.06|||Regression, Logistic||Low Tailored Message vs. No Message (reference group)|||2.06|0.88|0.165
73851485|NCT04904744|147250212|SUPERIORITY||Odds Ratio (OR)|1.33||||0.193|TWO_SIDED|95.0|0.87|2.03|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||2.03|0.87|0.193
73851486|NCT04904744|147250212|SUPERIORITY||Odds Ratio (OR)|1.02||||0.93|TWO_SIDED|95.0|0.68|1.52|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||1.52|0.68|0.930
73851487|NCT04904744|147250213|SUPERIORITY||Odds Ratio (OR)|2.07||||0.008|TWO_SIDED|95.0|1.21|3.52|||Regression, Logistic||Low Tailored Message vs. No Message|||3.52|1.21|0.008
73851488|NCT04904744|147250213|SUPERIORITY||Odds Ratio (OR)|1.25||||0.457|TWO_SIDED|95.0|0.7|2.23|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||2.23|0.70|0.457
73851489|NCT04904744|147250213|SUPERIORITY||Odds Ratio (OR)|1.66||||0.049|TWO_SIDED|95.0|1.0|2.74|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||2.74|1.00|0.049
73851490|NCT04904744|147250214|SUPERIORITY||Odds Ratio (OR)|2.04||||0.104|TWO_SIDED|95.0|0.86|4.82|||Regression, Logistic||Low Tailored Message vs. No Message|||4.82|0.86|0.104
73851491|NCT04904744|147250214|SUPERIORITY||Odds Ratio (OR)|1.26||||0.631|TWO_SIDED|95.0|0.49|3.22|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||3.22|0.49|0.631
73851492|NCT04904744|147250214|SUPERIORITY||Odds Ratio (OR)|1.62||||0.238|TWO_SIDED|95.0|0.73|3.61|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||3.61|0.73|0.238
73851493|NCT02819297|147250219|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73901906|NCT04445792|147333939|SUPERIORITY|||||||0.0517|||||||Wilcoxon (Mann-Whitney)|||||||0.0517
73851494|NCT01262638|147250258|SUPERIORITY||Difference in Least Squares Means|-15.7|||<|0.0001|TWO_SIDED|95.0|-21.8|-9.7|||ANCOVA|||||-9.7|-21.8|<0.0001
73851495|NCT01262638|147250258|SUPERIORITY||Difference in Least Squares Means|-22.9|||<|0.0001|TWO_SIDED|95.0|-28.9|-16.9|||ANCOVA|||||-16.9|-28.9|<0.0001
73851496|NCT01262638|147250258|SUPERIORITY||Difference in Least Squares Means|-24.5|||<|0.0001|TWO_SIDED|95.0|-30.5|-18.4|||ANCOVA|||||-18.4|-30.5|<0.0001
73851497|NCT00894699|147250276|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
73851498|NCT00894699|147250276|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73851499|NCT03928418|147250318|SUPERIORITY||Mean Difference (Net)|3.5|||<|0.001|TWO_SIDED|95.0|2.1|4.9||p-value comparing live call booster to SOC arm: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm reported here.|||4.9|2.1|<0.001
73851500|NCT03928418|147250318|SUPERIORITY||Mean Difference (Net)|3.6|||<|0.001|TWO_SIDED|95.0|2.2|5.1||p-value comparing technology booster to SOC arm: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm reported here.|||5.1|2.2|<0.001
73851501|NCT03928418|147250319|SUPERIORITY||Mean Difference (Net)|36.4||||0.643|TWO_SIDED|95.0|-117.5|190.3||p-value comparing live call booster arm to SOC arm: p = 0.643|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm reported here.|||190.3|-117.5|0.643
73851502|NCT03928418|147250319|SUPERIORITY||Mean Difference (Net)|-30.9||||0.711|TWO_SIDED|95.0|-194.8|132.9||p-value comparing technology booster arm to SOC arm: p = 0.711|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm reported here.|||132.9|-194.8|0.711
73851503|NCT03928418|147250320|SUPERIORITY||Mean Difference (Net)|-2.3||||0.515|TWO_SIDED|95.0|-9.3|4.7||p-value comparing live call booster arm to SOC: p = 0.515|Regression, Logistic||SOC minus live call booster arm presented here.|||4.7|-9.3|0.515
73851504|NCT03928418|147250320|SUPERIORITY||Mean Difference (Net)|-0.9||||0.801|TWO_SIDED|95.0|-8.3|6.4||p-value comparing technology booster arm to SOC: p = 0.801|Regression, Logistic||SOC minus technology booster arm presented here.|||6.4|-8.3|0.801
73851505|NCT03928418|147250321|SUPERIORITY||Mean Difference (Net)|28.9|||<|0.001|TWO_SIDED|95.0|17.0|40.7||p-value comparing live call booster arm to SOC: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC minus live call booster arm presented here.|||40.7|17.0|<0.001
73851506|NCT03928418|147250321|SUPERIORITY||Mean Difference (Net)|24.9|||<|0.001|TWO_SIDED|95.0|13.0|36.8||p-value comparing technology booster arm to SOC: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC minus technology booster arm presented here.|||36.8|13.0|<0.001
73851507|NCT03928418|147250322|SUPERIORITY||Mean Difference (Net)|4.4||||0.002|TWO_SIDED|95.0|1.6|7.3||p-value comparing live call booster arm to SOC: p = 0.002|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm presented here.|||7.3|1.6|0.002
73901907|NCT04445792|147333940|SUPERIORITY|||||||0.6835|||||||Wilcoxon (Mann-Whitney)|||||||0.6835
73851508|NCT03928418|147250322|SUPERIORITY||Mean Difference (Net)|4.3||||0.003|TWO_SIDED|95.0|1.5|7.2||p-value comparing technology booster arm to SOC: p = 0.003|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm presented here.|||7.2|1.5|0.003
73901908|NCT04445792|147333940|SUPERIORITY|||||||0.0205|||||||Wilcoxon (Mann-Whitney)|||||||0.0205
73901909|NCT04445792|147333940|SUPERIORITY|||||||0.0036|||||||Wilcoxon (Mann-Whitney)|||||||0.0036
73901910|NCT04445792|147333941|SUPERIORITY|||||||0.5878|||||||Wilcoxon (Mann-Whitney)|||||||0.5878
73901911|NCT04445792|147333941|SUPERIORITY|||||||0.1051|||||||Wilcoxon (Mann-Whitney)|||||||0.1051
73901912|NCT04445792|147333941|SUPERIORITY|||||||0.0292|||||||Wilcoxon (Mann-Whitney)|||||||0.0292
73851509|NCT03928418|147250324|SUPERIORITY||Mean Difference (Net)|-0.8||||0.61|TWO_SIDED|95.0|-3.8|2.2||p-value comparing live call booster arm to SOC arm: p = 0.610.|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm|SOC minus live call booster arm presented here.|||2.2|-3.8|0.610
73851510|NCT03928418|147250324|SUPERIORITY||Mean Difference (Net)|-1.1||||0.474|TWO_SIDED|95.0|-4.1|1.9||p-value comparing technology booster arm to SOC arm: p = 0.474.|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm|SOC minus technology booster arm presented here.|||1.9|-4.1|0.474
73851511|NCT01576939|147250366|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.9906|TWO_SIDED|95.0|0.979|1.022|||Regression, Cox|This was a Cox proportional hazards model with dose as the single predictor.||||1.022|0.979|0.9906
73851512|NCT01576939|147250367|SUPERIORITY_OR_OTHER||Slope|0.2795||||0.1209|TWO_SIDED|95.0|-0.077|0.634|||Regression, Linear|Linear regression model with dose as the single predictor in the model.||||0.634|-0.077|0.1209
73851513|NCT01576939|147250368|SUPERIORITY_OR_OTHER||Slope|-0.285||||0.9832|TWO_SIDED|95.0|-27.28|26.71|||Regression, Linear|Linear regression model with dose as the single predictor in the model.||||26.71|-27.28|0.9832
73851514|NCT01576939|147250369|SUPERIORITY_OR_OTHER||Slope|0.03795||||0.0263|TWO_SIDED|95.0|0.00483|0.071|||Mixed Models Analysis|A repeated measures model with dose as the single predictor. QoL values were measured for each patient every week.||||0.071|0.00483|0.0263
73901913|NCT04445792|147333942|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73901914|NCT04445792|147333942|SUPERIORITY|||||||0.5973|||||||Chi-squared|||||||0.5973
73901915|NCT04445792|147333942|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
73901916|NCT01206387|147333966|SUPERIORITY_OR_OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
73851515|NCT01576939|147250370|SUPERIORITY_OR_OTHER||Slope|0.0567||||0.0039|TWO_SIDED|95.0|0.0199|0.0935|||Mixed Models Analysis|A repeated measures model with dose as the single predictor and QoL values measured each week for each patient.||||0.0935|0.0199|0.0039
73851516|NCT01831466|147250397|SUPERIORITY_OR_OTHER||Difference in response rates|3.9|STANDARD_ERROR_OF_MEAN|6.36||0.5425|TWO_SIDED|80.0|-4.3|12.0|||Cochran-Mantel-Haenszel|||||12.0|-4.3|0.5425
73851517|NCT01831466|147250397|SUPERIORITY_OR_OTHER||Difference in response rates|-4.0|STANDARD_ERROR_OF_MEAN|5.87||0.4976|TWO_SIDED|80.0|-11.5|3.5|||Cochran-Mantel-Haenszel|||||3.5|-11.5|0.4976
73851518|NCT01831466|147250397|SUPERIORITY_OR_OTHER||Difference in response rates|3.3|STANDARD_ERROR_OF_MEAN|6.36||0.6039|TWO_SIDED|80.0|-4.9|11.5|||Cochran-Mantel-Haenszel|||||11.5|-4.9|0.6039
73851519|NCT01831466|147250397|SUPERIORITY_OR_OTHER||Difference in response rate|4.0|STANDARD_ERROR_OF_MEAN|6.34||0.5279|TWO_SIDED|80.0|-4.1|12.1|||Cochran-Mantel-Haenszel|||||12.1|-4.1|0.5279
73851520|NCT01831466|147250398|SUPERIORITY_OR_OTHER||Difference in response rates|10.8|STANDARD_ERROR_OF_MEAN|5.99||0.071|TWO_SIDED|80.0|3.1|18.5|||Cochran-Mantel-Haenszel|||||18.5|3.1|0.0710
73851521|NCT01831466|147250398|SUPERIORITY_OR_OTHER||Difference in response rates|-1.2|STANDARD_ERROR_OF_MEAN|5.2||0.8175|TWO_SIDED|80.0|-7.9|5.5|||Cochran-Mantel-Haenszel|||||5.5|-7.9|0.8175
73851522|NCT01831466|147250398|SUPERIORITY_OR_OTHER||Difference in response rates|11.0|STANDARD_ERROR_OF_MEAN|5.63||0.0513|TWO_SIDED|80.0|3.8|18.2|||Cochran-Mantel-Haenszel|||||18.2|3.8|0.0513
73851523|NCT01831466|147250398|SUPERIORITY_OR_OTHER||Difference in response rates|6.7|STANDARD_ERROR_OF_MEAN|5.23||0.2021|TWO_SIDED|80.0|0.0|13.4|||Cochran-Mantel-Haenszel|||||13.4|-0.0|0.2021
73901917|NCT01206387|147333967|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73901918|NCT01206387|147333968|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73901919|NCT01206387|147333969|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73901920|NCT01206387|147333970|SUPERIORITY_OR_OTHER|||||||0.0011|||||||t-test, 2 sided|||||||0.0011
73901921|NCT00706849|147333979|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 treatment groups.||||<0.001
73901922|NCT00706849|147333981|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
73901923|NCT00706849|147333983|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
73901924|NCT00706849|147333985|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
73901925|NCT00706849|147333987|SUPERIORITY_OR_OTHER|||||||0.042||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.042
73901926|NCT00706849|147333989|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
73901927|NCT00706849|147333991|SUPERIORITY_OR_OTHER|||||||0.023||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.023
73851524|NCT02311881|147250452|SUPERIORITY_OR_OTHER||LS mean difference|-2.51||||0.1626|TWO_SIDED|95.0|-6.037|1.016|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo."||1.016|-6.037|0.1626
73901928|NCT00706849|147333993|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
73851525|NCT02311881|147250452|NON_INFERIORITY_OR_EQUIVALENCE|Paracetamol 2000mg BID is non-inferior to Paracetamol 1330mg TID if the upper bound of the 95% confidence Interval is less than 5.3.|LS mean difference|-2.36|||||TWO_SIDED|95.0|-5.894|1.166|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is ≤ - 5.3 (inferiority).~H1: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is \> - 5.3 (noninferiority)."||1.166|-5.894|
73851526|NCT02311881|147250452|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.9352|TWO_SIDED|95.0|-3.687|3.394|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo."||3.394|-3.687|0.9352
73901929|NCT00706849|147333995|SUPERIORITY_OR_OTHER|||||||0.004||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.004
73901930|NCT00706849|147333997|SUPERIORITY_OR_OTHER|||||||0.207||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.207
73901931|NCT00920907|147334012|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.01|||||TWO_SIDED|90.0|0.916|1.114|||Least squared linear regression|||Biocomparability of ipilimumab Process C to ipilimumab Process B was concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for Cmax were contained within 80% to 125%.||1.114|0.916|
73901932|NCT00920907|147334016|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.032|||||TWO_SIDED|90.0|0.922|1.156|||Least squared linear regression|||Biocomparability of ipilimumab Process C to ipilimumab Process B was to be concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for ipilimumab Cmax were contained within 80% to 125%. Point estimates and 90% CIs were constructed for the ratio of geometric means (Process C/Process B) for ipilimumab Cmax.||1.156|0.922|
73901933|NCT00920907|147334021|SUPERIORITY_OR_OTHER||omnibus conditional F-test|0.4||||0.85||||||Not corrected for multiple testing|F-test|numerator 5 degrees freedom, denominator 782 degrees freedom||Time-by-process interaction. Null hypothesis that the pattern of mean ALC values over time is the same for both processes.||||0.85
73901934|NCT00920907|147334021|SUPERIORITY_OR_OTHER||F-statistic|4.35|||<|0.0001|||||||F-test|numerator 10 degrees freedom, denominator 782 degrees freedom||Overall time effect. Null hypothesis of no mean ALC changes over time in either process group (treatment arm).||||<0.0001
73901935|NCT02616601|147334029|EQUIVALENCE|If the 90% confidence interval on the percentage difference between generic fluorouracil cream and Carac (fluorouracil) cream lesion clearance were contained within the interval -0.20 to +0.20, and each of these percentages was greater than and statistically different (p\<0.05) from the vehicle cream percentage, then generic fluorouracil cream and Carac (fluorouracil) cream were considered to be therapeutically equivalent.|Mean Difference (Net)|0.04|||||TWO_SIDED|90.0|-11.03|11.11|||||90% Wald's confidence interval with a continuity correction for the difference (Generic Fluorouracil Cream - Carac \[Fluorouracil\] Cream) in complete clearance rates.|||11.11|-11.03|
73901936|NCT02616601|147334029|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73901937|NCT02616601|147334029|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73901938|NCT00039871|147334030|SUPERIORITY_OR_OTHER||Binomial Approximation|0.217||||||99.0|0.195|0.239||||||||0.239|0.195|
73901939|NCT00039871|147334031|SUPERIORITY_OR_OTHER||Binomial Approximation|0.563||||||95.0|0.529|0.596||||||||0.596|0.529|
73901940|NCT00039871|147334032|SUPERIORITY_OR_OTHER||Binomial Approximation|0.122||||||95.0|0.076|0.169||||||||0.169|0.076|
73901941|NCT02186301|147334033|OTHER||Kaplan-Meier Median|274.0|||||TWO_SIDED|95.0|109.0||Upper Confidence Limit is not available because it cannot be calculated||||||||109|
73901942|NCT02186301|147334033|OTHER||Kaplan-Meier Median|207.0|||||TWO_SIDED|95.0|112.0|260.0||||||||260.0|112.0|
73851527|NCT00819156|147250462|SUPERIORITY_OR_OTHER_LEGACY||Percentage|61.0||||||95.0|41.0|78.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||78|41|
73901943|NCT02186301|147334033|OTHER||Kaplan Meier Median|390.0|||||TWO_SIDED|95.0|282.0|499.0||||||||499.0|282.0|
73901944|NCT02186301|147334034|OTHER||Percentage|25.0|||||TWO_SIDED|95.0|8.7|49.1||||||||49.1|8.7|
73901945|NCT02186301|147334034|OTHER||Percentage|40.0|||||TWO_SIDED|95.0|22.7|59.4||||||||59.4|22.7|
73901946|NCT02186301|147334034|OTHER||Percentage|78.0|||||TWO_SIDED|95.0|64.0|88.5||||||||88.5|64.0|
73901947|NCT02186301|147334035|OTHER||Kaplan Meier Median|225.0|||||TWO_SIDED|95.0|113.0||Upper Confidence Limit is not available because it cannot be calculated.||||||||113|
73901948|NCT02186301|147334035|OTHER||Kaplan Meier Median|195.5|||||TWO_SIDED|95.0|143.0|617.0||||||||617.0|143.0|
73901949|NCT02186301|147334035|OTHER||Kaplan Meier Median|335.0|||||TWO_SIDED|95.0|282.0|480.0||||||||480.0|282.0|
73901950|NCT03560739|147334052|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 1.|Geo-mean ratio|1.03|||||TWO_SIDED|90.0|0.8|1.25|||||The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.|Criteria 1 for bioequivalence testing of AUCtau||1.25|.8|
74024382|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.76|-0.7|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.70|-1.76|<0.001
74024383|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.35|-0.3|||ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-1.35|0.002
73901951|NCT03560739|147334052|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 2.|95% upper bound of the linearized criter|-0.3131|||||ONE_SIDED|95.0||0.0|||||The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion|Criteria 2 for bioequivalence testing of AUCtau||0||
73901952|NCT03560739|147334053|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 1.|geo-mean ratio|1.0|||||TWO_SIDED|90.0|0.8|1.25|||||The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.|Criteria 1 for bioequivalence testing of Cmax||1.25|.8|
73901953|NCT03560739|147334053|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 2.|95% upper bound of the linearized criter|-0.2446|||||ONE_SIDED|95.0||0.0|||||The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion.|Criteria 2 for bioequivalence testing of Cmax||0||
73901954|NCT02478398|147334058|SUPERIORITY||Mean Difference (Final Values)|-2.73|||<|0.001|TWO_SIDED|95.0|-3.45|-2.0|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-2.00|-3.45|< 0.001
73901955|NCT02478398|147334059|SUPERIORITY||Difference in LS Mean|-1.86|||<|0.001|TWO_SIDED|95.0|-2.46|-1.27|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-1.27|-2.46|< 0.001
73901956|NCT02478398|147334060|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.001|TWO_SIDED|95.0|-1.81|-0.99|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-0.99|-1.81|< 0.001
73901957|NCT02478398|147334061|SUPERIORITY||Mean Difference (Final Values)|-1.84|||<|0.001|TWO_SIDED|95.0|-2.6|-1.08|||Zero-Inflated Log-Normal Model|Model included fixed effects of treatment, baseline asthma, age group, pollen season, and pollen region nested within pollen season||||-1.08|-2.60|< 0.001
73901958|NCT02478398|147334062|OTHER||Difference in % estimates|37.61|||<|0.001|TWO_SIDED|95.0|31.82|43.12|||Miettinen & Nurminen|||||43.12|31.82|< 0.001
73901959|NCT02478398|147334063|OTHER||Difference in % estimates|0.39|||=|0.32|TWO_SIDED|95.0|-0.57|1.53|||Miettinen & Nurminen|||||1.53|-0.57|= 0.320
73901960|NCT02478398|147334064|OTHER||Difference in % estimates|0.0|||=|0.996|TWO_SIDED|95.0|-0.92|0.92|||Miettinen & Nurminen|||||0.92|-0.92|= 0.996
73901961|NCT03123185|147334066|OTHER|No hypothesis was tested and no acceptance range was specified.|Geometric mean (gMean) ratio (%)|158.61|STANDARD_ERROR_OF_MEAN|22.4|||TWO_SIDED|90.0|133.679|188.195|||||gMean ratio = 10 mg BI 705564 fed/10 mg BI 705564 fast. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect subjects within sequences will be considered as random, the other effects as fixed."||188.195|133.679|
73901962|NCT03123185|147334067|OTHER|No hypothesis was tested and no acceptance range was specified.|gMean ratio (%)|194.18|STANDARD_ERROR_OF_MEAN|26.4|||TWO_SIDED|90.0|158.912|237.267|||||gMean ratio = 10 mg BI 705564 fed/10 mg BI 705564 fast. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect subjects within sequences will be considered as random, the other effects as fixed."||237.267|158.912|
73901963|NCT03123185|147334068|OTHER||Slope|0.4879|STANDARD_ERROR_OF_MEAN|0.0546|||TWO_SIDED|95.0|0.3767|0.599|||||Based on the estimate for slope parameter, a 2-sided 95% Confidence Interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fasted condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.5990|0.3767|
73901964|NCT03123185|147334068|OTHER||Slope|0.7553|STANDARD_ERROR_OF_MEAN|0.0876|||TWO_SIDED|95.0|0.5736|0.937|||||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.9370|0.5736|
73901965|NCT03123185|147334069|OTHER||Slope|0.4651|STANDARD_ERROR_OF_MEAN|0.1274|||TWO_SIDED|95.0|0.1935|0.7368|||||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fasted condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.7368|0.1935|
73901966|NCT03123185|147334069|OTHER||Slope|0.6651|STANDARD_ERROR_OF_MEAN|0.1385|||TWO_SIDED|95.0|0.3679|0.9622|||Power model||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.9622|0.3679|
73901967|NCT04243421|147334072|OTHER||Median Difference (Final Values)|6.0||||0.0007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0007
73901968|NCT04243421|147334073|OTHER||Median Difference (Final Values)|1.25||||0.0005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0005
74084745|NCT01849458|147722819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.6|STANDARD_DEVIATION|26.0||0.0001|TWO_SIDED|95.0|25.2|40.0|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)||40|25.2|0.0001
73851528|NCT00819156|147250462|SUPERIORITY_OR_OTHER_LEGACY||Percentage|84.0||||||95.0|64.0|95.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||95|64|
73851529|NCT00819156|147250462|SUPERIORITY_OR_OTHER_LEGACY||Percentage|96.0||||||95.0|81.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|81|
73851530|NCT00819156|147250462|SUPERIORITY_OR_OTHER_LEGACY||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|73|
73851531|NCT00819156|147250462|SUPERIORITY_OR_OTHER_LEGACY||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|73|
73851532|NCT00819156|147250462|SUPERIORITY_OR_OTHER_LEGACY||Percentage|92.0||||||95.0|74.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||99|74|
73851533|NCT00819156|147250463|SUPERIORITY_OR_OTHER_LEGACY||Percentage|92.0||||||95.0|80.0|98.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|80|
73851534|NCT00819156|147250463|SUPERIORITY_OR_OTHER_LEGACY||Percentage|96.0||||||95.0|86.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|86|
73851535|NCT00819156|147250463|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0||||||95.0|93.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|93|
73851536|NCT00819156|147250464|SUPERIORITY_OR_OTHER_LEGACY||Percentage|70.0||||||95.0|51.0|85.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||85|51|
73851537|NCT00819156|147250464|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0||||||95.0|75.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||98|75|
73851538|NCT00819156|147250464|SUPERIORITY_OR_OTHER_LEGACY||Percentage|97.0||||||95.0|84.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||100|84|
73851539|NCT00819156|147250464|SUPERIORITY_OR_OTHER_LEGACY||Percentage|97.0||||||95.0|83.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||100|83|
73901969|NCT04243421|147334073|OTHER||Median Difference (Final Values)|1.0||||0.0034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0034
73901970|NCT04243421|147334074|OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
73901971|NCT01249118|147334079|SUPERIORITY_OR_OTHER||Ratio of LS Means|8.45|||||TWO_SIDED|90.0|7.08|10.08|||||The 90 percent (%) confidence intervals (CI) of test group (oral dose) means relative to reference group (IV dose) means were obtained by taking antilog of corresponding 90% CI for the differences between the means on the log scale.|Least squares (LS) mean was calculated from analysis of variance (ANOVA). Data for dose-normalized Cmax were natural log-transformed prior to analysis.||10.08|7.08|
73901972|NCT01249118|147334083|SUPERIORITY_OR_OTHER||Ratio of LS Means|48.6|||||TWO_SIDED|90.0|41.43|56.94|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS means was calculated from ANOVA. Data for dose-normalized AUC (0 - t) were natural log-transformed prior to analysis.||56.94|41.43|
73851540|NCT00819156|147250464|SUPERIORITY_OR_OTHER_LEGACY||Percentage|94.0||||||95.0|80.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|80|
73851541|NCT00819156|147250464|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|77.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|77|
73851542|NCT00819156|147250465|SUPERIORITY_OR_OTHER_LEGACY||Percentage|83.0||||||95.0|65.0|94.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||94|65|
73851543|NCT00819156|147250465|SUPERIORITY_OR_OTHER_LEGACY||Percentage|94.0||||||95.0|79.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|79|
73851544|NCT00819156|147250465|SUPERIORITY_OR_OTHER_LEGACY||Percentage|87.0||||||95.0|70.0|96.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||96|70|
73851545|NCT00819156|147250465|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|78|
73851546|NCT00819156|147250465|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0||||||95.0|76.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||98|76|
73851547|NCT00819156|147250465|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|78|
73851548|NCT00819156|147250466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0933||95.0|||||Log Rank|||||||0.0933
73851549|NCT00819156|147250467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.165||95.0|||||Log Rank|||||||0.165
73851550|NCT00819156|147250468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.429||95.0|||||Log Rank|||||||0.429
74084746|NCT01849458|147722820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.7|STANDARD_DEVIATION|23.6||0.0001|TWO_SIDED|95.0|28.7|42.7|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)||42.7|28.7|0.0001
73901973|NCT01249118|147334085|SUPERIORITY_OR_OTHER||Ratio of LS Means|45.9|||||TWO_SIDED|90.0|39.74|53.06|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS mean was calculated from ANOVA. Data for dose-normalized AUC (0 - ∞) were natural log-transformed prior to analysis.||53.06|39.74|
73901974|NCT00095238|147334114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.8|1.3|||Mixed Models Analysis|baseline score used as covariate; treatment, visit, treatment-by-visit, \& baseline angiotensin-converting enzyme (ACE) inhibitors used as predictors||Comparison of 2 treatment arms at Month 6 (first 2 columns)||1.3|-0.8|
73901975|NCT00095238|147334114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.5|1.7|||Mixed Models Analysis|baseline score used as covariate; treatment, visit, treatment-by-visit, \& baseline angiotensin-converting enzyme (ACE) inhibitors used as predictors||comparison of 2 treatment arms at Month 14 (columns 3 and 4)||1.7|-0.5|
73901976|NCT03828370|147334185|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
73901977|NCT03828370|147334186|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||.034
73901978|NCT00461331|147334187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|96.4|STANDARD_DEVIATION|8.5||0.52||95.0|87.9|100.0|||Regression, Linear|7 patients underwent early termination of either one or both of their test period due to loss of glycemic control||Glucose levels for patients when they were on each insulin were analyzed. All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables. This was a pilot study.||100.0|87.9|0.52
73901979|NCT00461331|147334188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.35|STANDARD_DEVIATION|4.165||0.15||95.0|0.97|9.23|||Regression, Linear||This was between days 3 and 5 after the last pump infusion line change using Insulin Aspart and Insulin Lispro. Adequate samples were not available to do the analysis for day 2.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.||9.23|0.97|0.15
73901980|NCT00461331|147334189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.7|STANDARD_DEVIATION|2.35||0.55||95.0|4.4|9.4|||Regression, Linear||This was for test period 1 between days 3 and 5 after the last pump infusion line change.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.||9.4|4.4|0.55
73901981|NCT02554279|147334190|NON_INFERIORITY|The study had at least 80% power, to demonstrate the non-inferiority of menotropin to recombinant FSH at 1-sided significance level of 0.025 with a -12% non-inferiority margin.|Absolute difference|4.7|||||TWO_SIDED|95.0|-2.7|12.1||||||Null hypothesis was defined as the difference between ongoing pregnancy rate of participants randomized and treated with menotropin and recombinant FSH, as ≤-12%.||12.1|-2.7|
73901982|NCT02554279|147334191|OTHER||Absolute difference|1.2|||||TWO_SIDED|95.0|-6.6|8.9||||||||8.9|-6.6|
73901983|NCT02554279|147334192|OTHER||Absolute difference|3.8|||||TWO_SIDED|95.0|-3.8|11.3||||||||11.3|-3.8|
73901984|NCT02554279|147334193|OTHER||Absolute difference|-9.5|||||TWO_SIDED|95.0|-19.2|0.2||||||||0.2|-19.2|
73901985|NCT02360605|147334212|SUPERIORITY|||||||0.61||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||FIT completion rates were defined as the percentage of FIT tests returned. Screening ratios were defined as the PC to AC ratio of FIT completion rates. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. A test for interaction between literacy level and study arm were assessed.||||0.61
73901986|NCT02360605|147334213|SUPERIORITY|||||||0.3||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.||||0.30
73901987|NCT02360605|147334214|SUPERIORITY|||||||0.97||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.||||0.97
73901988|NCT00740051|147334224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.86|-0.29||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo||-0.29|-0.86|<0.0001
73901989|NCT00740051|147334225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.88|-0.32||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo. The primary analysis performed at the interim was re-run at the end of the study to accommodate changes made to the final study database.||-0.32|-0.88|<0.0001
73901990|NCT00740051|147334226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.5|STANDARD_ERROR_OF_MEAN|5.4||0.0002||95.0|-31.1|-9.9||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo||-9.9|-31.1|0.0002
74084747|NCT01849458|147722821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.8|STANDARD_DEVIATION|22.2||0.0001|TWO_SIDED|95.0|37.4|50.1|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)||50.1|37.4|0.0001
73961849|NCT01068743|147460379|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|98.22|||||TWO_SIDED|90.0|94.28|102.32|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||102.32|94.28|
73901991|NCT00740051|147334227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.576||||0.0374||95.0|1.057|6.279||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo||6.279|1.057|0.0374
73901992|NCT00740051|147334228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.285||||0.1281||95.0|0.71|15.196||No adjustment of p-values|Regression, Logistic|||Linagliptin vs. Placebo||15.196|0.710|0.1281
73961850|NCT01068743|147460379|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL|1724.4||||||||||||||Geometric least squares means for Treatment A.||||
73961851|NCT01068743|147460379|SUPERIORITY_OR_OTHER||Geometric Least Square Means (ng/mL)|1715.8||||||||||||||Geometric least squares means for Treatment B.||||
73961852|NCT01068743|147460379|SUPERIORITY_OR_OTHER||Geometric Least Square Mean (ng/mL)|1581.4||||||||||||||Geometric least squares means for Treatment C.||||
73961853|NCT01068743|147460379|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1553.2||||||||||||||Geometric least squares means for Treatment D.||||
73961854|NCT01068743|147460384|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|101.43|||||TWO_SIDED|90.0|98.07|104.9|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|||104.90|98.07|
73961855|NCT01068743|147460384|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|102.52|||||TWO_SIDED|90.0|99.56|105.57|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|||105.57|99.56|
73961856|NCT01068743|147460384|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|47.15|||||||||||||Geometric least squares means for Treatment A.|||||
73961857|NCT01068743|147460384|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|47.83|||||||||||||Geometric least squares means for Treatment B.|||||
73961858|NCT01068743|147460384|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|50.89|||||||||||||Geometric least squares means for Treatment C.|||||
73961859|NCT01068743|147460384|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|52.17|||||||||||||Geometric least squares means for Treatment D.|||||
73961860|NCT01068743|147460387|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|100.41|||||TWO_SIDED|90.0|95.4|105.68|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|||105.68|95.40|
73901993|NCT00740051|147334229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.801||||0.0046||95.0|1.374|5.711||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo||5.711|1.374|0.0046
73901994|NCT01673282|147334254|SUPERIORITY_OR_OTHER||Least Square Mean|-0.24|STANDARD_ERROR_OF_MEAN|0.06|=|0.0003|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Based on an ANCOVA model for absolute change in ratio of dose and DDD with group as a fixed effect and the ratio of dose and DDD at Baseline as a covariate.||-0.11|-0.36|=0.0003
73901995|NCT03935399|147334255|SUPERIORITY|Exploratory analysis without power calculation||||||0.83|||||||ANOVA|Repeated measures one factor ANOVA||Exploratory analysis without power calculation||||0.83
73901996|NCT03935399|147334256|SUPERIORITY|Exploratory analysis without power calculation||||||0.92|||||||ANOVA|One factor repeated measures ANOVA||Exploratory analysis without power calculation||||0.92
73961861|NCT01068743|147460387|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|99.06|||||TWO_SIDED|90.0|96.19|102.02|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|||102.02|96.19|
73961862|NCT01068743|147460387|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11827.0|||||||||||||Geometric least squares means for Treatment A.|||||
73961863|NCT01068743|147460387|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11875.0|||||||||||||Geometric least squares means for Treatment B.|||||
73961864|NCT01068743|147460387|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11845.0|||||||||||||Geometric least squares means for Treatment C.|||||
73961865|NCT01068743|147460387|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11734.0|||||||||||||Geometric least squares means for Treatment D.|||||
73961866|NCT02507752|147460392|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Physical component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).||||< 0.001
73961867|NCT02507752|147460392|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||ANOVA|||Mental component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).||||= 0.014
73961868|NCT02507752|147460394|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||ANOVA|||Mean change from Baseline in ESR at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.021
73961869|NCT02507752|147460394|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||ANOVA|||Mean change from Baseline in ESR at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.003
73961870|NCT02507752|147460395|SUPERIORITY_OR_OTHER||||||=|0.744|TWO_SIDED||||||ANOVA|||Mean change from Baseline in CRP at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.744
73961871|NCT02507752|147460395|SUPERIORITY_OR_OTHER||||||=|0.646|TWO_SIDED||||||ANOVA|||Mean change from Baseline in CRP at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.646
73961872|NCT02507752|147460396|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in SJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
73961873|NCT02507752|147460396|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in SJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
73901997|NCT03935399|147334257|SUPERIORITY|Exploratory analysis without power calculation||||||0.79|||||||ANOVA|One factor repeated measures ANOVA||Exploratory analysis without power calculation||||0.79
73901998|NCT03935399|147334258|SUPERIORITY|Exploratory analysis without power calculation||||||0.93||||||Exploratory analysis without power calculation|ANOVA|One factor repeated measures ANOVA||||||0.93
73901999|NCT03935399|147334259|SUPERIORITY|Exploratory analysis without power calculation||||||0.89||||||Exploratory analysis without power calculation|ANOVA|Two factor repeated measures ANOVA||||||0.89
73902000|NCT03935399|147334260|SUPERIORITY|Exploratory analysis without power calculation||||||0.83||||||Exploratory analysis without power calculation|ANOVA|Two way repeated measures ANOVA||||||0.83
73902001|NCT03935399|147334261|SUPERIORITY|Exploratory analysis without power caclulation||||||0.57||||||Exploratory analysis without power caclulation|ANOVA|Two way repeated measures ANOVA||||||0.57
73902002|NCT01112683|147334262|SUPERIORITY_OR_OTHER|||||||0.403|ONE_SIDED|90.0|||||Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||20 subjects per group were expected to provide 60% power to detect a between-group mean difference of 1.2 correct patterns (change from baseline to week 16) on the Paired Associates Learning and to provide 40% power to detect a between-group mean difference of 1.2 patterns recognized on the Pattern Recognition Memory. A two-sided test at type I error rate of 5% was used. Sample size incorporated an inflation factor of 20% to account for ineligibility of 10% of randomized participants.||||0.403
73902003|NCT01112683|147334263|SUPERIORITY_OR_OTHER|||||||0.371|ONE_SIDED|90.0||||This P-Value refers to the SIB-R Broad independence score.|Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||No power calculations were performed for the secondary measures.||||0.371
73902004|NCT02915874|147334275|SUPERIORITY||Slope|-1.13|STANDARD_ERROR_OF_MEAN|0.47||0.02|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.02
73902005|NCT02915874|147334276|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.78||0.19|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.19
73902006|NCT02915874|147334277|SUPERIORITY||Slope|2.07|STANDARD_ERROR_OF_MEAN|1.86||0.27|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.27
73902007|NCT02915874|147334278|SUPERIORITY||Slope|-0.49|STANDARD_ERROR_OF_MEAN|21.3||0.98|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.98
73902008|NCT02915874|147334279|SUPERIORITY||Slope|1.03|STANDARD_ERROR_OF_MEAN|2.58||0.69|TWO_SIDED|||||a priori: 0.05|Mixed Models Analysis|||||||0.69
73902009|NCT02915874|147334280|SUPERIORITY||Slope|-2.77|STANDARD_ERROR_OF_MEAN|4.93||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
73902010|NCT02915874|147334281|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.58||0.08|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.08
73902011|NCT02290431|147334282|SUPERIORITY||||||<|0.0001|||||||single-sample binomial test|||||||< 0.0001
73902012|NCT02119676|147334301|OTHER||Hazard Ratio (HR)|1.04||||0.588|TWO_SIDED|95.0|0.73|1.49||1-sided|Log Rank|Log-rank test stratified by modified Glasgow Prognostic Score (mGPS) and geographical region.|Estimated using a Cox regression model with Efron's method used for ties, stratified by mGPS score and geographical region|||1.49|0.73|0.588
73902013|NCT02119676|147334301|OTHER||Hazard Ratio (HR)|0.77||||0.136|TWO_SIDED|95.0|0.48|1.23||1-sided|Log Rank|Log rank test stratified by geographical region.|Estimated using Cox regression model with Efron's method used for ties, stratified by geographical region|||1.23|0.48|0.136
73902014|NCT00219544|147334307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|0.25||0.0018||95.0|-1.27|-0.3|||ANCOVA||Difference = pregabalin minus placebo|The study is powered to detect clinically significant difference of 1.2 between treatment groups in mean pain score at end of treatment. The statistical sample size calculation requires a total of 144 subjects to complete the Double-Blind phase of the study: a sample size of 72 in each treatment group will have 90% power to detect a difference in treatment mean pain scores of 1.2 assuming that the common standard deviation is 2.2 using a two group t-test with a 0.05 two-sided significance level.||-0.30|-1.27|0.0018
73961874|NCT02507752|147460397|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in TJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
73902015|NCT00219544|147334310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|0.22||0.001||95.0|-1.15|-0.3|||ANCOVA||pregabalin minus placebo|Week 5||-0.30|-1.15|0.0010
73902016|NCT00219544|147334310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.41|-0.53|||ANCOVA||pregabalin minus placebo|Week 6||-0.53|-1.41|<.0001
73902017|NCT00219544|147334310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 7||-0.47|-1.39|<.0001
73902018|NCT00219544|147334310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 8||-0.47|-1.39|<.0001
73902019|NCT00219544|147334310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0022||95.0|-1.14|-0.25|||ANCOVA||pregabalin minus placebo|Week 9||-0.25|-1.14|0.0022
73902020|NCT00219544|147334316|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.24||0.0031||95.0|-1.18|-0.24|||ANCOVA|||||-0.24|-1.18|0.0031
73902021|NCT00219544|147334319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.22||0.0177||95.0|-0.94|-0.09|||ANCOVA||pregabalin minus placebo|Week 5||-0.09|-0.94|0.0177
73961875|NCT02507752|147460397|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in TJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
73851551|NCT00803595|147250476|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 18 hours (h) was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|-0.6||||0.748|TWO_SIDED|95.0|-9.9|6.9||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.||6.9|-9.9|0.748
73851552|NCT00803595|147250476|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.8||||0.038|TWO_SIDED|95.0|-18.2|-0.4||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||Null hypothesis was that there was no difference in the time to illness alleviation||-0.4|-18.2|0.038
73851553|NCT00803595|147250476|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 18 hours was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|12.2||||0.104|TWO_SIDED|95.0|-1.5|17.2|||Generalized Wilcoxon test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.||17.2|-1.5|0.104
73851554|NCT00803595|147250477|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.3||||0.318|TWO_SIDED|95.0|-2.8|9.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||9.1|-2.8|0.318
73851555|NCT00803595|147250477|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.981|TWO_SIDED|95.0|-5.8|5.7||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||5.7|-5.8|0.981
73851556|NCT00803595|147250477|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.7||||0.344|TWO_SIDED|95.0|-9.1|3.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||3.1|-9.1|0.344
73851557|NCT01575808|147250485|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0|||<|0.0001|ONE_SIDED|95.0|86.3||||z-test|One-sided z-test||A literature-based Surgical Bypass Efficacy Goal of 65% was compared to the percentage of subjects maintaining primary assisted patency at 12 months. A one-sided z-test using a Type I error of 5% was performed to test the hypotheses that the 12-month primary assisted patency probability of GP1101 is superior to the SBEG of 65%.|||86.3|<0.0001
73851558|NCT01575808|147250486|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Hypothesis is that the post-procedure hospital stay duration for GP1101 is superior to the post-procedure hospital stay for the retrospective surgical bypass group.||||<0.0001
73851559|NCT01575808|147250487|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0|||<|0.0001|TWO_SIDED|95.0|96.5|100.0|||Fisher Exact||Confidence interval calculated with binomial exact method.|The hypothesis is that the rate of avoidance of general anesthesia for GP1101 is superior to the rate of avoidance of general anesthesis for the retrospective surgical bypass group.||100|96.5|<0.0001
73851560|NCT01575808|147250488|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0|||||TWO_SIDED|95.0|96.5|100.0|||||Confidence intervals calculated using the binomial exact method.|||100.0|96.5|
73851561|NCT01575808|147250518|OTHER||Percentage|97.1|||||TWO_SIDED|95.0|91.7|99.4||||||||99.4|91.7|
73851562|NCT01575808|147250538|OTHER||Percentage|100.0|||||TWO_SIDED|95.0|96.5|100.0|||||Confidence Interval calculated with binomial exact method.|||100.0|96.5|
73851563|NCT02403817|147250565|OTHER|This is a small pilot study with no power calculations required (and no data upon which to base a priori power estimates).||||||5e-05|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary attention outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).||||0.00005
73851564|NCT02403817|147250566|OTHER|||||||0.018|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary eye movement outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).||||0.018
73902022|NCT00219544|147334319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.31|-0.44|||ANCOVA||pregabalin minus placebo|Week 6||-0.44|-1.31|<.0001
73851565|NCT01701362|147250605|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1823||95.0|-0.54|0.1|||Mixed Model Repeated Measures Analysis|Mixed Model Repeated Measures = MMRM|MMRM analysis includes fixed categorical effects of treatment, country, trauma type, visit week, treatment-by-visit interaction, and fixed continuous effect of baseline value. Missing mean pain scores imputed by multiple imputation method|||0.10|-0.54|0.1823
73851566|NCT01701362|147250606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||||||The p-value is derived from CMH test, stratified for pooled center and trauma type and excludes missing values.|Cochran-Mantel-Haenszel|||||||0.0012
73851567|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.14||0.0119||95.0|-0.62|-0.08|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 1||-0.08|-0.62|0.0119
74084748|NCT01849458|147722822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.2|STANDARD_DEVIATION|20.2||0.0001|TWO_SIDED|95.0|43.2|55.2|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)||55.2|43.2|0.0001
74084749|NCT00781079|147722825|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Models included site, age, race, ethnicity.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.||||.5
74084750|NCT00781079|147722826|SUPERIORITY||Z tests if Reg coeff are diff from 0|-0.58||||0.56|TWO_SIDED||||||Regression, Linear|||||||.56
74084751|NCT00781079|147722827|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||Models included site, age, race, ethnicity. This is the calculated p value.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.||||.05
74084752|NCT00781079|147722828|SUPERIORITY||Z test if reg coeff is diff from 0|0.56||||0.58|TWO_SIDED||||||Regression, Linear|||||||.58
73851568|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.0135||95.0|-0.62|-0.07|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 2||-0.07|-0.62|0.0135
73961876|NCT02507752|147460398|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in DAS28 at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
73851569|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.14||0.0028||95.0|-0.69|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 3||-0.14|-0.69|0.0028
73851570|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0016||95.0|-0.72|-0.17|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 4||-0.17|-0.72|0.0016
73851571|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0007||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 5||-0.20|-0.75|0.0007
73851572|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0006||95.0|-0.76|-0.21|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 6||-0.21|-0.76|0.0006
73851573|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0008||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 7||-0.20|-0.75|0.0008
73851574|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.14||0.0003||95.0|-0.79|-0.24|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 8||-0.24|-0.79|0.0003
74084753|NCT00781079|147722829|SUPERIORITY||Z test if reg coeff is diff than 0|-0.16||||0.87|TWO_SIDED||||||Regression, Linear|||||||.87
74084754|NCT00781079|147722830|SUPERIORITY||Z test if ref coeff is diff than 0|0.03||||0.98|TWO_SIDED||||||Regression, Linear|||||||.98
73851575|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001||95.0|-0.82|-0.26|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 9||-0.26|-0.82|0.0001
73851576|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0005||95.0|-0.77|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 10||-0.22|-0.77|0.0005
73961877|NCT02507752|147460398|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in DAS28 at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
74084755|NCT00345033|147722839|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in total cholesterol is over 99%.||||||0.125||95.0|||||ANCOVA|||||||0.125
74084756|NCT00345033|147722840|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in weight will be over 99%.||||||0.109||95.0|||||ANCOVA|||||||0.109
74084757|NCT00345033|147722841|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in Body Mass Index (BMI) will be over 99%.||||||0.229||95.0|||||ANCOVA|||||||0.229
74084758|NCT00345033|147722842|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in glucose metabolism to be 90%.||||||0.01||95.0|||||ANCOVA|||||||0.010
74084759|NCT00345033|147722843|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in triglycerides will be 81%.||||||0.982||95.0|||||ANCOVA|||||||0.982
74084760|NCT00345033|147722844|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in Insulin Resistance will be 90%.||||||0.082||95.0|||||ANCOVA|||||||0.082
74088268|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-12.69|STANDARD_ERROR_OF_MEAN|3.74||0.001|TWO_SIDED|95.0|-20.11|-5.26|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-5.26|-20.11|0.0010
73851577|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0007||95.0|-0.76|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 11||-0.20|-0.76|0.0007
73851578|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001||95.0|-0.82|-0.27|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 12||-0.27|-0.82|0.0001
73851579|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.84|-0.28|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 13||-0.28|-0.84|<0.0001
73851580|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.0005||95.0|-0.78|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 14||-0.22|-0.78|0.0005
73851581|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.15||0.0031||95.0|-0.71|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 15||-0.14|-0.71|0.0031
73851582|NCT01701362|147250607|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12||0.0001||95.0|-0.71|-0.23|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Overall||-0.23|-0.71|0.0001
73851583|NCT01701362|147250608|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.005||95.0|-0.77|-0.14|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||||-0.14|-0.77|0.0050
73851584|NCT01701362|147250609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.16||0.0168||95.0|-0.7|-0.07|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||||-0.07|-0.70|0.0168
73851585|NCT01701362|147250610|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.6841||95.0|-0.09|0.06|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for mobility||0.06|-0.09|0.6841
73851586|NCT01701362|147250610|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.029||0.6564||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for self-care||0.04|-0.07|0.6564
73851587|NCT01701362|147250610|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.043||0.859||95.0|-0.08|0.09|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for usual activities||0.09|-0.08|0.8590
73851588|NCT01701362|147250610|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.043||0.1628||95.0|-0.14|0.02|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for pain/discomfort||0.02|-0.14|0.1628
73851589|NCT01701362|147250610|SUPERIORITY_OR_OTHER_LEGACY||leaset squares mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.037||0.4654||95.0|-0.05|0.1|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for anxiety/depression||0.10|-0.05|0.4654
73851590|NCT01701362|147250610|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.017||0.5||95.0|-0.02|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 1997 Index score||0.04|-0.02|0.5000
73851591|NCT01701362|147250610|SUPERIORITY_OR_OTHER_LEGACY||leaset squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.026||0.5493||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 2001 Index Score||0.04|-0.07|0.5493
73851592|NCT01701362|147250612|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|3.5|STANDARD_ERROR_OF_MEAN|1.8||0.0545||95.0|-0.07|7.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Disturbance Score||7.00|-0.07|0.0545
73851593|NCT01701362|147250612|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.29||0.3913||95.0|-6.47|2.54|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Adequancy Score||2.54|-6.47|0.3913
73851594|NCT01701362|147250612|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-1.1|STANDARD_ERROR_OF_MEAN|2.04||0.6059||95.0|-5.06|2.96|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Snoring Score||2.96|-5.06|0.6059
73902023|NCT00219544|147334319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.82|STANDARD_ERROR_OF_MEAN|0.23||0.0005||95.0|-1.28|-0.36|||ANCOVA||pregabalin minus placebo|Week 7||-0.36|-1.28|0.0005
73902024|NCT00219544|147334319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|0.23||0.0003||95.0|-1.31|-0.39|||ANCOVA||pregabalin minus placebo|Week 8||-0.39|-1.31|0.0003
73902025|NCT00219544|147334319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.22||0.0011||95.0|-1.18|-0.3|||ANCOVA||pregabalin minus placebo|Week 9||-0.30|-1.18|0.0011
73902026|NCT00219544|147334320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.0|STANDARD_ERROR_OF_MEAN|3.3||0.0069||95.0|-15.5|-2.5|||ANCOVA|||||-2.5|-15.5|0.0069
73902027|NCT00219544|147334321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.0023||95.0|-2.1|-0.5|||ANCOVA||pregabalin minus placebo|HADS-A||-0.5|-2.1|0.0023
73851595|NCT01701362|147250612|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.7||0.7317||95.0|-2.76|3.93|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Awaken Short of Breath Score||3.93|-2.76|0.7317
73902028|NCT00219544|147334321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0013||95.0|-1.9|-0.5|||ANCOVA||pregabalin minus placebo|HADS-D||-0.5|-1.9|0.0013
73902029|NCT00219544|147334322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.98|STANDARD_ERROR_OF_MEAN|3.42||0.0828||95.0|-0.79|12.75|||ANCOVA||pregabalin minus placebo|Impact||12.75|-0.79|0.0828
73902030|NCT00219544|147334322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.49|STANDARD_ERROR_OF_MEAN|2.75||0.0197||95.0|1.05|11.94|||ANCOVA||pregabalin minus placebo|Satisfaction||11.94|1.05|0.0197
73902031|NCT00219544|147334323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0278||95.0|||||Mantel Haenszel|||The distribution of the responses to the PGIC at EOT was compared between the 2 treatment groups using the 7 categories of the PGIC.||||0.0278
73902032|NCT00219544|147334324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.76|STANDARD_ERROR_OF_MEAN|0.26||0.0049||95.0|-1.28|-0.23|||ANCOVA|||Pain interference||-0.23|-1.28|0.0049
73851596|NCT01701362|147250612|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.2663||95.0|-0.45|0.12|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Quantity of Sleep Score (hours)||0.12|-0.45|0.2663
73851597|NCT01701362|147250612|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.5||0.1562||95.0|-5.08|0.82|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Somnolence Score||0.82|-5.08|0.1562
73851598|NCT01701362|147250612|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|1.7|STANDARD_ERROR_OF_MEAN|1.45||0.249||95.0|-1.18|4.53|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Problem Index (9) Score||4.53|-1.18|0.2490
73851599|NCT01701362|147250612|SUPERIORITY_OR_OTHER_LEGACY||leaet squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0609||95.0|-0.15|0.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Optimal Sleep Score||0.00|-0.15|0.0609
73851600|NCT01701362|147250613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7165||||||p-values based on CMH test stratified by pooled center and trauma type, patients with unknown status at baseline or endpoint will not be included in the calculation of p-values.|Cochran-Mantel-Haenszel|||||||0.7165
73902033|NCT00219544|147334324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.77|STANDARD_ERROR_OF_MEAN|0.26||0.0037||95.0|-1.29|-0.25|||ANCOVA|||Pain severity||-0.25|-1.29|0.0037
73902034|NCT00219544|147334325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0719||95.0|0.0|0.11|||ANCOVA||pregabalin minus placebo|Health State Profile||0.11|-0.00|0.0719
73902035|NCT00219544|147334325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|2.54||0.418||95.0|-2.96|7.1|||ANCOVA||pregabalin minus placebo|Visual Analog Scale||7.10|-2.96|0.4180
73902036|NCT01007253|147334329|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean eye symptoms score difference among the four treatment groups.||||<0.001
73902037|NCT01007253|147334330|SUPERIORITY_OR_OTHER|||||||0.05|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean nasal symptoms score difference among the four treatment groups.||||0.05
73851601|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2||||0.0028||95.0|1.5|6.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1||6.86|1.50|0.0028
73851602|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.036||95.0|1.03|2.68|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2||2.68|1.03|0.0360
73851603|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.0235||95.0|1.07|2.45|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3||2.45|1.07|0.0235
73851604|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.0619||95.0|0.98|2.24|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4||2.24|0.98|0.0619
73851605|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.0677||95.0|0.97|2.2|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5||2.20|0.97|0.0677
73902038|NCT01007253|147334331|SUPERIORITY_OR_OTHER|||||||0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean sneeze difference among the four treatment groups.||||0.001
73902039|NCT01007253|147334332|SUPERIORITY_OR_OTHER|||||||0.11|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean histamine level difference among the four treatment groups.||||0.11
73902040|NCT01007253|147334333|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean tryptase level difference among the four treatment groups.||||<0.001
73902041|NCT00814801|147334335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||0.0113|TWO_SIDED|95.0|-2.64|-0.34|||Least Square Means|||||-0.34|-2.64|0.0113
73902042|NCT00814801|147334335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59|||<|0.0001|TWO_SIDED|95.0|-3.74|-1.44|||Least Square Means|||||-1.44|-3.74|<0.0001
74024384|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|95.0|-1.39|-0.34|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.34|-1.39|0.001
73902043|NCT00814801|147334337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.0774|TWO_SIDED|95.0|-0.2|3.7|||Least Square Means|||||3.7|-0.2|0.0774
74084761|NCT01294449|147722885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.37|TWO_SIDED|95.0|0.67|1.161|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D group over the hazard rate of mortality in the ICD group. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|The sample size for the analysis included subjects from the original MADIT-CRT IDE (NCT00180271) that did not participate in the Registry portion, these subjects are censored at the time of study conclusion, withdrawal or death during the IDE. This was done as the Registry is a post approval continuation of the follow-up from the MADIT-CRT IDE trial. This is not a pooled analysis from separate studies.||1.161|0.670|0.370
73851606|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.0707||95.0|0.97|2.16|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6||2.16|0.97|0.0707
73851607|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.1313||95.0|0.91|2.06|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7||2.06|0.91|0.1313
73851608|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.3072||95.0|0.82|1.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8||1.86|0.82|0.3072
73851609|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.3947||95.0|0.79|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9||1.80|0.79|0.3947
73851610|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.1462||95.0|0.9|2.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10||2.05|0.90|0.1462
73851611|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.6854||95.0|0.72|1.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11||1.64|0.72|0.6854
73851612|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.5025||95.0|0.76|1.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12||1.74|0.76|0.5025
73902044|NCT00814801|147334337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.6207|TWO_SIDED|95.0|-1.5|2.4|||Least Square Means|||||2.4|-1.5|0.6207
73902045|NCT00814801|147334338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.8419|TWO_SIDED|95.0|-0.6|0.8|||Least Square Means|||||0.8|-0.6|0.8419
74024385|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.94|-0.9|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.90|-1.94|<0.001
73851613|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.4908||95.0|0.76|1.76|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13||1.76|0.76|0.4908
73851614|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.4245||95.0|0.78|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14||1.80|0.78|0.4245
73851615|NCT01701362|147250614|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.8464||95.0|0.61|1.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15||1.49|0.61|0.8464
73851616|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.11||||0.1633||95.0|0.74|6.0|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1||6.00|0.74|0.1633
73851617|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.92||||0.0652||95.0|0.96|3.85|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2||3.85|0.96|0.0652
73851618|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2||||0.0039||95.0|1.29|3.77|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3||3.77|1.29|0.0039
73851619|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.0382||95.0|1.03|2.83|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4||2.83|1.03|0.0382
73851620|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86||||0.0137||95.0|1.14|3.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5||3.05|1.14|0.0137
73902046|NCT00814801|147334338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7942|TWO_SIDED|95.0|-0.8|0.6|||Least Square Means|||||0.6|-0.8|0.7942
73902047|NCT00814801|147334339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.3141|TWO_SIDED|95.0|-1.6|0.5|||Least Square Means|||||0.5|-1.6|0.3141
74024386|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.7|-0.58|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.70|<0.001
74024387|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.57|-0.45|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.45|-1.57|<0.001
73851621|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0693||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6||2.49|0.97|0.0693
73851622|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.0349||95.0|1.04|2.73|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7||2.73|1.04|0.0349
73902048|NCT00814801|147334339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.6089|TWO_SIDED|95.0|-1.3|0.8|||Least Square Means|||||0.8|-1.3|0.6089
73851623|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.1227||95.0|0.91|2.29|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8||2.29|0.91|0.1227
73851624|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.65||||0.0364||95.0|1.03|2.63|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9||2.63|1.03|0.0364
73851625|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0667||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10||2.49|0.97|0.0667
73851626|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||0.0176||95.0|1.1|2.84|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11||2.84|1.10|0.0176
73902049|NCT02751931|147334353|OTHER||Mean Difference (Net)|72.09|||<|0.001|TWO_SIDED|95.0|45.28|98.89||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||98.89|45.28|<0.001
73902050|NCT02751931|147334353|OTHER||Mean Difference (Net)|113.21|||<|0.001|TWO_SIDED|95.0|78.95|147.47||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||147.47|78.95|<0.001
73902051|NCT02751931|147334354|OTHER||Mean Difference (Net)|-4.09||||0.618|TWO_SIDED|95.0|-20.55|12.38||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||12.38|-20.55|0.618
73902052|NCT02751931|147334354|OTHER||Mean Difference (Net)|15.16||||0.005|TWO_SIDED|95.0|5.1|25.22||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||25.22|5.10|0.005
73902053|NCT02751931|147334354|OTHER||Mean Difference (Net)|14.62||||0.055|TWO_SIDED|95.0|-0.31|29.54||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||29.54|-0.31|0.055
73902054|NCT02751931|147334354|OTHER||Mean Difference (Net)|13.59|||<|0.001|TWO_SIDED|95.0|6.75|20.42||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||20.42|6.75|<0.001
73902055|NCT02751931|147334355|OTHER||Mean Difference (Net)|41.36|||<|0.001|TWO_SIDED|95.0|18.75|63.97||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change from Baseline at week 4 - Children.||63.97|18.75|<0.001
73851627|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.03||||0.003||95.0|1.27|3.23|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12||3.23|1.27|0.0030
73851628|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.0256||95.0|1.07|2.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13||2.74|1.07|0.0256
73902056|NCT02751931|147334355|OTHER||Mean Difference (Net)|80.78|||<|0.001|TWO_SIDED|95.0|39.2|122.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||122.36|39.20|<0.001
73902057|NCT02751931|147334356|OTHER||Mean Difference (Net)|0.44||||0.632|TWO_SIDED|95.0|-1.4|2.28||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||2.28|-1.40|0.632
73902058|NCT02751931|147334356|OTHER||Mean Difference (Net)|-0.64||||0.321|TWO_SIDED|95.0|-1.94|0.67|||t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||0.67|-1.94|0.321
73902059|NCT02751931|147334356|OTHER||Mean Difference (Net)|-1.86||||0.011|TWO_SIDED|95.0|-3.27|-0.45||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||-0.45|-3.27|0.011
74024388|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.91|-0.79|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.79|-1.91|<0.001
74024389|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.29||0.021|TWO_SIDED|95.0|-1.26|-0.1|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-1.26|0.021
73851629|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.0314||95.0|1.05|2.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14||2.64|1.05|0.0314
73851630|NCT01701362|147250615|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.1889||95.0|0.85|2.21|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15||2.21|0.85|0.1889
73851631|NCT00443872|147250637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|1.0|<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Comparison of mean group scores at baseline and 12 weeks||||<0.01
73851632|NCT00443872|147250638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
73851633|NCT00443872|147250639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided||Comparison of baseline vs. 3 month circumference of the Left and Right lower leg/ankle (change identical for both legs).|Change in pedal edema as measured by change in lower leg/ankle circumference in the left and right legs||||<0.01
73851634|NCT00443872|147250640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
73851635|NCT00443872|147250641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This analysis is for the Activities of Daily Living (ADL) section of the scale||||<0.01
73851636|NCT00443872|147250641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|||||This analysis is for the motor section of the UPDRS|Wilcoxon (Mann-Whitney)|||||||<0.05
73851637|NCT00443872|147250642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
73851638|NCT00443872|147250643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73851639|NCT00443872|147250644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73851640|NCT00443872|147250645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
74084762|NCT01294449|147722885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.028|TWO_SIDED|95.0|0.484|0.96|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D arm over the hazard rate of mortality in the ICD arm. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|These data represent the indicated sub population of left bundle branch block subjects only. (Left bundle branch block N= 110 ICD group: 181 CRT-D group)||0.960|0.484|0.028
73851641|NCT00485758|147250654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-21.4|-14.4|||Wilcoxon (Mann-Whitney)|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline low-density lipoprotein cholesterol -by-time interaction.||||-14.4|-21.4|<0.001
73851642|NCT00485758|147250655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|20.7|25.7|||Repeated Measures Analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline high-density lipoprotein cholesterol -by-time interaction.||||25.7|20.7|<0.001
73851643|NCT00485758|147250656|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.1|||<|0.001||95.0|-27.2|-18.9|||ANCOVA|Nonparametric Analysis of Covariance model based on Tukey's normalized ranks with term for treatment, gender and Tukey's normal score of baseline.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval based on Wilcoxon's rank|||-18.9|-27.2|<0.001
73851644|NCT04551963|147250657|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.49|||||TWO_SIDED|90.0|0.42|0.56||||||Arm A: Zanubrutinib alone vs. Zanubrutinib + fluconazole||0.56|0.42|
73851645|NCT04551963|147250657|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.42|||||TWO_SIDED|90.0|0.34|0.51||||||Arm a: Zanubrutinib alone vs. Zanubrutinib + diltiazem||0.51|0.34|
73851646|NCT04551963|147250658|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.81|||||TWO_SIDED|90.0|0.66|0.99||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||0.99|0.66|
73851647|NCT04551963|147250658|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.49|||||TWO_SIDED|90.0|0.41|0.58||||||Arm B: Zanubrutinib alone vs zanubrutinib + clarithromycin||0.58|0.41|
73851648|NCT04551963|147250659|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.94|||||TWO_SIDED|90.0|0.82|1.08||||||Arm A: Zanubrutinib alone vs. zanubrutinib + fluconazole||1.08|0.82|
73902060|NCT02751931|147334356|OTHER||Mean Difference (Net)|-0.77||||0.359|TWO_SIDED|95.0|-2.49|0.94||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||0.94|-2.49|0.359
73902061|NCT02751931|147334357|OTHER||Mean Difference (Net)|-12.38|||<|0.001|TWO_SIDED|95.0|-18.56|-6.21||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||-6.21|-18.56|<0.001
73902062|NCT02751931|147334357|OTHER||Mean Difference (Net)|-6.48||||0.334|TWO_SIDED|95.0|-20.09|7.13||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||7.13|-20.09|0.334
73961878|NCT02507752|147460399|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
74024390|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.29||0.029|TWO_SIDED|95.0|-1.22|-0.07|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.07|-1.22|0.029
73851649|NCT04551963|147250659|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.81|||||TWO_SIDED|90.0|0.66|0.99||||||Arm A: Zanubrutinib alone vs. zanubrutinib + diltiazem||0.99|0.66|
73851650|NCT04551963|147250660|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.83|||||TWO_SIDED|90.0|0.65|1.06||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||1.06|0.65|
73851651|NCT04551963|147250660|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.48|||||TWO_SIDED|90.0|0.4|0.58||||||Arm B: Zanubrutinib alone vs zanubrutinib + clarithromycin||0.58|0.40|
73851652|NCT04551963|147250661|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.45|||||TWO_SIDED|90.0|0.35|0.58||||||Arm A: Zanubrutinib alone vs. zanubrutinib + fluconazole||0.58|0.35|
73851653|NCT04551963|147250661|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.41|||||TWO_SIDED|90.0|0.32|0.51||||||Arm A: Zanubrutinib alone vs. zanubrutinib + diltiazem||0.51|0.32|
73851654|NCT04551963|147250662|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.82|||||TWO_SIDED|90.0|0.68|1.0||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||1.00|0.68|
73851655|NCT04551963|147250662|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.5|||||TWO_SIDED|90.0|0.39|0.64||||||Arm B: Zanubrutinib alone vs. zanubrutinib + clarithromycin||0.64|0.39|
73961879|NCT02507752|147460399|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
73851656|NCT00700622|147250684|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 92 subjects in each group was required to complete the trial. Approximately 230 subjects were to be randomized to achieve 184 completers (assuming a 20% dropout rate). This would have provided 80% power for a noninferiority design to test the difference of a 4-month change in HbA1c levels between treatment groups, assuming the upper noninferiority margins Δ of 0.5% with a standard deviation of 1.2 and a 1-sided alpha of 0.025.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|95.0|-0.31|0.17|||ANCOVA|||||0.17|-0.31|
73851657|NCT00383331|147250685|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher Exact|||The response rates are separately evaluated for these two treatment arms. For each arm, a sample size of 48 achieves 91% power to detect a difference of 20% between the null hypothesis of 15% response rate and the alternative hypothesis of 35% using a one-sided, binomial hypothesis test with a target significance level of 2.5% (the actual significance level is 2.2%).||||0.48
73851658|NCT00383331|147250690|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Log Rank|||||||0.56
73851659|NCT04852055|147250711|SUPERIORITY||average marginal effect|-2.8|||||TWO_SIDED|95.0|-6.1|0.5||||||||0.5|-6.1|
73851660|NCT04852055|147250712|SUPERIORITY||average marginal effect|-0.6|||||TWO_SIDED|95.0|-3.0|1.8||||||||1.8|-3.0|
73851661|NCT01204905|147250715|OTHER|This was a pilot study with a small sample population. There were no power calculations performed.|||||||||||||||||The percentage of patients with HIV-1 viral loads less than 50 c/ml at 48 weeks.|||
73851662|NCT01204905|147250716|OTHER|There were no power calculations performed due to the size of the pilot study.|||||||||||||||||Number of weeks to virologic suppression|||
73851663|NCT02550288|147250760|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-36.3|||<|0.001|TWO_SIDED|95.0|-40.5|-32.2|||Constrained longitudinal data analysis|||||-32.2|-40.5|<0.001
73851664|NCT02550288|147250760|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-11.6|||<|0.001|TWO_SIDED|95.0|-14.9|-8.2|||Constrained longitudinal data analysis|||||-8.2|-14.9|<0.001
73851665|NCT02550288|147250760|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-39.9|||<|0.001|TWO_SIDED|95.0|-44.1|-35.8|||Constrained longitudinal data analysis|||||-35.8|-44.1|<0.001
73851666|NCT02550288|147250760|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-10.1|||<|0.001|TWO_SIDED|95.0|-13.5|-6.8|||Constrained longitudinal data analysis|||||-6.8|-13.5|<0.001
73851667|NCT00803361|147250781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.006|TWO_SIDED|95.0|-2.76|-0.48||p-value is for Change from Baseline.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.48|-2.76|0.006
73961880|NCT02507752|147460400|SUPERIORITY_OR_OTHER||||||=|0.011|TWO_SIDED||||||ANOVA|||Change in HAQ score from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.011
73961881|NCT02507752|147460400|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Change in HAQ score from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
73851668|NCT00803361|147250782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.024|TWO_SIDED|95.0|-4.78|-0.34||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.34|-4.78|0.024
73851669|NCT00803361|147250783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.004|TWO_SIDED|95.0|-0.74|-0.15|||ANOVA|||||-0.15|-0.74|0.004
73851670|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.125|TWO_SIDED|95.0|-0.93|0.11||p-value is for Severity of Worst Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.11|-0.93|0.125
73851671|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.014|TWO_SIDED|95.0|-0.75|-0.09||p-value is for Severity of Least Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.09|-0.75|0.014
73851672|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.012|TWO_SIDED|95.0|-0.93|-0.11||p-value is for Severity of Average Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.11|-0.93|0.012
73851673|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.002|TWO_SIDED|95.0|-1.14|-0.25||p-value is for Severity of Pain Right Now Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.25|-1.14|0.002
73851674|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.101|TWO_SIDED|95.0|-0.87|0.08||p-value is for Interference of Pain, General Activity, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.08|-0.87|0.101
73851675|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.252|TWO_SIDED|95.0|-0.83|0.22||p-value is for Interference of Pain, Mood, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.22|-0.83|0.252
73851676|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.149|TWO_SIDED|95.0|-0.72|0.11||p-value is for Interference of Pain,Walking Ability, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.11|-0.72|0.149
73851677|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.367|TWO_SIDED|95.0|-0.71|0.26||p-value is for Interference of Pain, Normal Work, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.26|-0.71|0.367
73851678|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.395|TWO_SIDED|95.0|-0.59|0.24||p-value is for Interference of Pain, Relations with Others, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.24|-0.59|0.395
73851679|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.731|TWO_SIDED|95.0|-0.63|0.44||p-value is for Interference of Pain, Sleep, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.44|-0.63|0.731
73851680|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.186|TWO_SIDED|95.0|-0.85|0.17||p-value is for Interference of Pain, Enjoyment of Life, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.17|-0.85|0.186
73851681|NCT00803361|147250784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.22|TWO_SIDED|95.0|-0.67|0.16||p-value is for Mean Interference Score, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.16|-0.67|0.220
73851682|NCT00803361|147250785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.076|TWO_SIDED|95.0|-1.29|0.06||p-value is for symptoms have disrupted your work/schoolwork - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.06|-1.29|0.076
73851683|NCT00803361|147250785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.14|TWO_SIDED|95.0|-1.16|0.17||p-value is for symptoms disrupted social/leisure - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.17|-1.16|0.140
73851684|NCT00803361|147250785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.087|TWO_SIDED|95.0|-1.14|0.08||p-value is for symptoms disrupted family life - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.08|-1.14|0.087
73851685|NCT00803361|147250785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.083|TWO_SIDED|95.0|-3.46|0.21||p-value is for Global Functional Impairment Total Score - change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.21|-3.46|0.083
73851686|NCT00803361|147250786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.32||||0.063|TWO_SIDED|95.0|-10.93|0.3||p-value is for Severity of Overall Pain, Past Week, Change|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||0.30|-10.93|0.063
73851687|NCT00803361|147250786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.66|TWO_SIDED|95.0|-6.64|4.22||p-value is for Severity of Headaches, Past Week, Change.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||4.22|-6.64|0.660
73851688|NCT00803361|147250786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03||||0.025|TWO_SIDED|95.0|-11.3|-0.76||p-value is for Severity of Back Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.76|-11.30|0.025
73851689|NCT00803361|147250786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.93||||0.26|TWO_SIDED|95.0|-8.06|2.19||p-value is for Severity of Shoulder Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||2.19|-8.06|0.260
73851690|NCT00803361|147250786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.67||||0.145|TWO_SIDED|95.0|-8.61|1.28||p-value is for Pain Interference, Daily Activities, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||1.28|-8.61|0.145
73851691|NCT00803361|147250786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.15||||0.011|TWO_SIDED|95.0|-12.64|-1.66||p-value is for Pain During Waking Hours, Past Week, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-1.66|-12.64|0.011
73851692|NCT00803361|147250787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.068|TWO_SIDED|95.0|-1.72|0.06||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.06|-1.72|0.068
73851693|NCT03629223|147250788|EQUIVALENCE|Analysis was performed with Equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%. In the below, LS-means = least squares mean.|Percentage of Ratio of Geometric LS-Mean|115.35|||||TWO_SIDED|90.0|108.55|122.58||||||||122.58|108.55|
73851694|NCT03629223|147250788|OTHER||Percentage of ratio of Geometric LS-Mean|186.37|||||TWO_SIDED|90.0|163.61|212.28||||||||212.28|163.61|
73961882|NCT02507752|147460401|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change in pain scale from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
73902063|NCT02751931|147334357|OTHER||Mean Difference (Net)|-18.11|||<|0.001|TWO_SIDED|95.0|-24.87|-11.35||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||-11.35|-24.87|<0.001
73851695|NCT03629223|147250788|OTHER||Percentage of ratio of Geometric LS-Mean|163.15|||||TWO_SIDED|90.0|146.17|182.1||||||||182.10|146.17|
73851696|NCT03629223|147250789|EQUIVALENCE|Analysis was performed with Equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%.|Percentage of ratio of Geometric LS-Mean|115.34|||||TWO_SIDED|90.0|108.51|122.6||||||||122.60|108.51|
73851697|NCT03629223|147250789|OTHER||Percentage of ratio of Geometric LS-Mean|186.67|||||TWO_SIDED|90.0|163.78|212.77||||||||212.77|163.78|
73851698|NCT03629223|147250789|OTHER||Percentage of ratio of Geometric LS-Mean|163.26|||||TWO_SIDED|90.0|146.09|182.46||||||||182.46|146.09|
73851699|NCT03629223|147250790|EQUIVALENCE|Analysis was performed with equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%.|Percentage of ratio of Geometric LS-Mean|113.57|||||TWO_SIDED|90.0|107.62|119.85||||||||119.85|107.62|
73851700|NCT03629223|147250790|OTHER||Percentage of ratio of Geometric LS-Mean|236.51|||||TWO_SIDED|90.0|215.69|259.34||||||||259.34|215.69|
73851701|NCT03629223|147250790|OTHER||Percentage of ratio of Geometric LS-Mean|199.61|||||TWO_SIDED|90.0|176.44|225.82||||||||225.82|176.44|
73851702|NCT02674464|147250809|SUPERIORITY||Odds Ratio (OR)|0.9||||0.68|TWO_SIDED|95.0|0.62|1.3||The a priori threshold for statistical significance was \<0.05.|Generalized Estimating Equations (GEE)|Assuming an exchangeable correlation structure|CC/SC arm compared to the SCP arm.|||1.30|0.62|0.68
73851703|NCT02674464|147250810|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.6|TWO_SIDED|95.0|-1.32|2.3||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression||CC/SC arm was compared to the SCP arm.|||2.30|-1.32|0.60
73851704|NCT02674464|147250811|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.38|TWO_SIDED|95.0|-1.04|2.71||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression|||||2.71|-1.04|0.38
73902064|NCT02751931|147334357|OTHER||Mean Difference (Net)|-13.19||||0.005||95.0|-22.02|-4.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||-4.36|-22.02|0.005
73961883|NCT02507752|147460401|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change in pain scale from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
74024391|NCT00733902|147600902|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.78|-0.62|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.62|-1.78|<0.001
73851705|NCT02674464|147250812|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.05|TWO_SIDED|95.0|-2.43|0.01||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression||CC/SC arm compared to SCP arm.|||0.01|-2.43|0.05
73851706|NCT00191945|147250874|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-11.0|-4.8|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at week 12 (Atomoxetine minus Placebo)|||-4.8|-11.0|<0.001
73851707|NCT00191945|147250875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.5|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.5|-3.6|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at Week 9 (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-3.6|-9.5|<0.001
73851708|NCT00191945|147250876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2|STANDARD_ERROR_OF_MEAN|1.5||0.0009||95.0|-8.2|-2.2|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 6 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-2.2|-8.2|0.0009
73851709|NCT00191945|147250877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.3||0.0033||95.0|-6.4|-1.3|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 4 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-1.3|-6.4|0.0033
73902065|NCT02751931|147334358|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Children||||<0.001
73902066|NCT02751931|147334358|OTHER|||||||0.148||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Adolescents||||0.148
73902067|NCT02751931|147334358|OTHER|||||||0.002||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Children||||0.002
73961884|NCT02507752|147460402|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Physical component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
73851710|NCT00191945|147250878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.1||0.013||95.0|-4.9|-0.6||P-value is for the difference between groups in the change from 12 weeks minus 6 weeks.|Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from 6 weeks to 12 weeks|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-0.6|-4.9|0.013
74024392|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.27||0.044|TWO_SIDED|95.0|-1.07|-0.02|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-1.07|0.044
74024393|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.875|TWO_SIDED|95.0|-0.57|0.48|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.48|-0.57|0.875
74024394|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.129|TWO_SIDED|95.0|-0.93|0.12|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.12|-0.93|0.129
74024395|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.46|-0.41|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.46|<0.001
74024396|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||L Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.27||0.004|TWO_SIDED|95.0|-1.28|-0.24|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-1.28|0.004
74024397|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.71|-0.67|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.67|-1.71|<0.001
74024398|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.26||0.002|TWO_SIDED|95.0|-1.33|-0.3|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-1.33|0.002
74024399|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.46|-0.43|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.43|-1.46|<0.001
74024400|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.04|-1.02|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.04|<0.001
74024401|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.56|-0.51|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.51|-1.56|<0.001
74024402|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.52|-0.46|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.46|-1.52|<0.001
73851711|NCT00191945|147250881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.7|STANDARD_ERROR_OF_MEAN|2.3|<|0.001||95.0|-15.1|-6.2||P-value is for the difference between groups in the change from 12 weeks minus baseline.|Mixed Models Analysis|mixed model repeated measures analyis: treatment, visit, patient, and CPRS-R: S Total score at baseline as covariate, with treatment\*visit interaction|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from baseline to 12 weeks.|||-6.2|-15.1|<0.001
73851712|NCT00191945|147250882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.81||95.0|-3.39|4.33||P-value for Parent: Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||4.33|-3.39|0.810
73851713|NCT00191945|147250882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.96||||0.243||95.0|-1.35|5.29||P-value for Parent: Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||5.29|-1.35|0.243
73902068|NCT02751931|147334358|OTHER|||||||0.039||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Adolescents||||0.039
73902069|NCT02751931|147334359|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Children||||<0.001
73902070|NCT02751931|147334359|OTHER|||||||0.007||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Adolescents||||0.007
73902071|NCT02751931|147334359|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Children||||< 0.001
73902072|NCT02751931|147334359|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Adolescents||||< 0.001
73851714|NCT00191945|147250882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.56||||0.419||95.0|-2.26|5.39||P-value for Parent: Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||5.39|-2.26|0.419
73851715|NCT00191945|147250882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.41|||<|0.001||95.0|4.27|12.55||P-value for Parent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||12.55|4.27|<0.001
73851716|NCT00191945|147250882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.39||||0.042||95.0|0.13|6.65||P-value for Parent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||6.65|0.13|0.042
73851717|NCT00191945|147250882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.323||95.0|-4.06|1.35||P-value for Child/Adolescent:Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||1.35|-4.06|0.323
73851718|NCT00191945|147250882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92||||0.452||95.0|-1.49|3.34||P-value for Child/Adolescent:Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||3.34|-1.49|0.452
73851719|NCT00191945|147250882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.91||95.0|-2.59|2.9||P-value for Child/Adolescent:Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||2.90|-2.59|0.910
73851720|NCT00191945|147250882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.006||95.0|1.04|6.08||P-value for Child/Adolescent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||6.08|1.04|0.006
73851721|NCT00191945|147250882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.541||95.0|-2.21|4.19||P-value for Child/Adolescent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||4.19|-2.21|0.541
73851722|NCT03583359|147250933|SUPERIORITY||Difference in Responder Rate|66.8|||<|0.0001|TWO_SIDED|95.0|53.7|75.2|||Fisher's exact test|The Fisher's exact test was utilized to test the superiority of treatment (Radiesse \[+\]) over control group.|Two-sided Newcombe confidence intervals (CIs) were calculated for difference in responder rate.|||75.2|53.7|<0.0001
73851723|NCT02470585|147250958|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.435|||<|0.001|TWO_SIDED|95.0|0.277|0.683||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.683|0.277|<0.001
73851724|NCT02470585|147250959|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.572|||<|0.001|TWO_SIDED|95.0|0.433|0.756||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.756|0.433|<0.001
73961885|NCT02507752|147460402|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Mental component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
73961886|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.102|TWO_SIDED||||||ANOVA|||Physical functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.102
73902073|NCT02751931|147334360|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||||<0.001
73902074|NCT02751931|147334360|OTHER|||||||0.006||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||||0.006
73902075|NCT02751931|147334360|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||||< 0.001
73902076|NCT02751931|147334360|OTHER|||||||0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||||0.001
73902077|NCT02751931|147334361|OTHER||Mean Difference (Net)|14.58||||0.035|TWO_SIDED|95.0|1.0|28.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||28.1|1.0|0.035
73902078|NCT02751931|147334361|OTHER||Mean Difference (Net)|35.99||||0.003|TWO_SIDED|95.0|13.1|58.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||58.9|13.1|0.003
73902079|NCT02751931|147334361|OTHER||Mean Difference (Net)|30.08|||<|0.001|TWO_SIDED|95.0|14.7|45.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||45.5|14.7|<0.001
73902080|NCT02751931|147334361|OTHER||Mean Difference (Net)|51.96|||<|0.001|TWO_SIDED|95.0|24.6|79.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||79.3|24.6|<0.001
73902081|NCT02751931|147334361|OTHER||Mean Difference (Net)|36.9|||<|0.001|TWO_SIDED|95.0|22.7|51.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||51.1|22.7|<0.001
73902082|NCT02751931|147334361|OTHER||Mean Difference (Net)|45.1|||<|0.001|TWO_SIDED|95.0|21.3|68.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||68.9|21.3|<0.001
73902083|NCT02751931|147334361|OTHER||Mean Difference (Net)|32.25|||<|0.001|TWO_SIDED|95.0|18.2|46.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||46.3|18.2|<0.001
74024403|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.85|-1.90|<0.001
73902084|NCT02751931|147334361|OTHER||Mean Difference (Net)|43.94||||0.001|TWO_SIDED|95.0|19.2|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||68.6|19.2|0.001
73902085|NCT02751931|147334361|OTHER||Mean Difference (Net)|41.63|||<|0.001|TWO_SIDED|95.0|23.3|60.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||60.0|23.3|<0.001
73902086|NCT02751931|147334361|OTHER||Mean Difference (Net)|59.31||||0.002|TWO_SIDED|95.0|23.8|94.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||94.9|23.8|0.002
73902087|NCT02751931|147334361|OTHER||Mean Difference (Net)|53.87|||<|0.001|TWO_SIDED|95.0|24.5|83.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||83.2|24.5|<0.001
73902088|NCT02751931|147334361|OTHER||Mean Difference (Net)|52.14||||0.002|TWO_SIDED|95.0|20.5|83.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||83.8|20.5|0.002
73902089|NCT02751931|147334361|OTHER||Mean Difference (Net)|42.84|||<|0.001|TWO_SIDED|95.0|22.0|63.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||63.7|22.0|<0.001
73902090|NCT02751931|147334361|OTHER||Mean Difference (Net)|42.4||||0.008|TWO_SIDED|95.0|12.5|72.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||72.3|12.5|0.008
73902091|NCT02751931|147334362|OTHER||Mean Difference (Net)|17.5||||0.126|TWO_SIDED|95.0|-5.1|40.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.1|-5.1|0.126
73902092|NCT02751931|147334362|OTHER||Mean Difference (Net)|42.38||||0.014|TWO_SIDED|95.0|9.3|75.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||75.4|9.3|0.014
73902093|NCT02751931|147334362|OTHER||Mean Difference (Net)|46.69|||<|0.001|TWO_SIDED|95.0|21.7|71.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||71.7|21.7|<0.001
73902094|NCT02751931|147334362|OTHER||Mean Difference (Net)|73.25||||0.002|TWO_SIDED|95.0|29.3|117.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||117.2|29.3|0.002
73902095|NCT02751931|147334362|OTHER|Pre-Specified|Mean Difference (Net)|45.27|||<|0.001|TWO_SIDED|95.0|22.1|68.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||68.4|22.1|<0.001
73902096|NCT02751931|147334362|OTHER||Mean Difference (Net)|42.86||||0.02|TWO_SIDED|95.0|7.4|78.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||78.3|7.4|0.020
73902097|NCT02751931|147334362|OTHER||Mean Difference (Net)|33.23||||0.003|TWO_SIDED|95.0|12.2|54.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||54.3|12.2|0.003
73851725|NCT02470585|147250960|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.683|||<|0.001|TWO_SIDED|95.0|0.562|0.831||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.831|0.562|<0.001
73851726|NCT02470585|147250961|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.215||||0.335|TWO_SIDED|95.0|0.821|1.799|||Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.799|0.821|0.335
73851727|NCT02470585|147250962|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.1||||0.462|TWO_SIDED|95.0|0.855|1.414|||Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.414|0.855|0.462
73851728|NCT02470585|147250963|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.073||||0.45|TWO_SIDED|95.0|0.895|1.287|||Log Rank|Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.287|0.895|0.450
73851729|NCT02470585|147250964|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.328|TWO_SIDED|95.0|0.567|1.429||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above|Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.429|0.567|0.328
73851730|NCT02470585|147250964|SUPERIORITY||Hazard Ratio (HR)|1.218||||0.808|TWO_SIDED|95.0|0.78|1.903||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.903|0.780|0.808
73851731|NCT02470585|147250965|SUPERIORITY||Hazard Ratio (HR)|0.844||||0.116|TWO_SIDED|95.0|0.64|1.114||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.114|0.640|0.116
73902098|NCT02751931|147334362|OTHER||Mean Difference (Net)|47.29||||0.003|TWO_SIDED|95.0|17.8|76.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||76.8|17.8|0.003
73902099|NCT02751931|147334362|OTHER||Mean Difference (Net)|49.88||||0.004|TWO_SIDED|95.0|17.1|82.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||82.6|17.1|0.004
73902100|NCT02751931|147334362|OTHER||Mean Difference (Net)|84.39||||0.003|TWO_SIDED|95.0|31.6|137.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||137.1|31.6|0.003
73902101|NCT02751931|147334362|OTHER||Mean Difference (Net)|60.09||||0.003|TWO_SIDED|95.0|21.2|99.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||99.0|21.2|0.003
73902102|NCT02751931|147334362|OTHER||Mean Difference (Net)|54.78||||0.017|TWO_SIDED|95.0|10.6|98.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||98.9|10.6|0.017
73902103|NCT02751931|147334362|OTHER||Mean Difference (Net)|53.51||||0.001|TWO_SIDED|95.0|22.6|84.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||84.4|22.6|0.001
73902104|NCT02751931|147334362|OTHER||Mean Difference (Net)|54.3||||0.021|TWO_SIDED|95.0|9.0|99.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||99.6|9.0|0.021
73851732|NCT02470585|147250965|SUPERIORITY||Hazard Ratio (HR)|0.949||||0.352|TWO_SIDED|95.0|0.726|1.242||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.242|0.726|0.352
73851733|NCT02470585|147250966|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.283|TWO_SIDED|95.0|0.782|1.144||Stratified by residual disease (none after primary surgery vs any residual disease after primary/interval surgery); disease stage (III vs IV); paclitaxel dosing (Q-weekly vs Q3-weekly); BRCA-Deficient status (Deficient vs wildtype or unknown/missing)|Log Rank|||Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.144|0.782|0.283
73851734|NCT02470585|147250966|SUPERIORITY||Hazard Ratio (HR)|1.034||||0.638|TWO_SIDED|95.0|0.859|1.244||Stratified by residual disease (none after primary surgery vs any residual disease after primary/interval surgery); disease stage (III vs IV); paclitaxel dosing (Q-weekly vs Q3-weekly); BRCA-Deficient status (Deficient vs wildtype or unknown/missing)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.244|0.859|0.638
73851735|NCT00434993|147250975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.3||0.087|TWO_SIDED|95.0|-4.7|0.3||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||The trial had a statistical power of 90.7% to detect a 2.25-day increase in VFDs,assuming a SD of 10.5 days. A group sequential design was used.||0.3|-4.7|0.087
73851736|NCT00434993|147250976|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.3||||0.302|TWO_SIDED|95.0|-4.0|14.7||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.||||14.7|-4.0|0.302
73851737|NCT00434993|147250977|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.9||||0.261|TWO_SIDED|95.0|-3.7|15.4||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.||||15.4|-3.7|0.261
73851738|NCT00434993|147250978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.023|TWO_SIDED|95.0|-4.9|-0.4||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||||-0.4|-4.9|0.023
73851739|NCT00434993|147250979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.226|TWO_SIDED|95.0|-4.3|0.9||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||||0.9|-4.3|0.226
73851740|NCT00434993|147250980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.13|TWO_SIDED|95.0|-5.3|0.6|||ANCOVA|Adjusted for baseline shock.||||0.6|-5.3|0.130
73851741|NCT00434993|147250981|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.2||||0.176|TWO_SIDED|95.0|-3.1|19.6|||Regression, Logistic|Adjusted for baseline shock.||||19.6|-3.1|0.176
73851742|NCT00434993|147250982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.048|TWO_SIDED|95.0|-7.8|0.0|||ANCOVA|||||-0.0|-7.8|0.048
73851743|NCT00434993|147250983|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.5||||0.265|TWO_SIDED|95.0|-6.9|25.9|||Regression, Logistic|||||25.9|-6.9|0.265
73851744|NCT02218697|147250997|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.13|||||TWO_SIDED|95.0|0.88|1.46|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H1N1 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.46|0.88|
73851745|NCT02218697|147250997|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.97|||||TWO_SIDED|95.0|0.78|1.21|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H3N2 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.21|0.78|
73851746|NCT02218697|147250997|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.17|||||TWO_SIDED|95.0|0.98|1.4|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Victoria strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.40|0.98|
73851747|NCT02218697|147250997|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.84|1.16|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Yamagata strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.16|0.84|
73851748|NCT02218697|147250998|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.14|||||TWO_SIDED|95.0|0.86|1.5|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 01 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.50|0.86|
73961887|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||ANOVA|||Physical functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.008
74024404|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.27||0.03|TWO_SIDED|95.0|-1.12|-0.06|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-1.12|0.030
73851749|NCT02218697|147250998|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.18|||||TWO_SIDED|95.0|0.96|1.45|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 03 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.45|0.96|
73851750|NCT02218697|147250998|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.26|||||TWO_SIDED|95.0|0.98|1.62|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 04 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.62|0.98|
73851751|NCT02218697|147250998|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.24|||||TWO_SIDED|95.0|0.95|1.63|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 7F serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.63|0.95|
73851752|NCT02218697|147250998|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.2|||||TWO_SIDED|95.0|0.91|1.57|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 14 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.57|0.91|
73851753|NCT02218697|147250998|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.34|||||TWO_SIDED|95.0|1.05|1.7|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 19A serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.70|1.05|
73851754|NCT03306433|147251027|EQUIVALENCE|The null hypothesis is that there are no significant paired differences between the groups. The power calculation is based on the observed variation and number of participants|Paired difference t-test|-12.139|STANDARD_DEVIATION|7.101||0.0003|TWO_SIDED|||||Paired difference p value comparing UDMA-K18 vs Adhesive Control|Paired difference test, 2 sided||There are 12 participants (pairs) for this comparison|Paired difference test within each participant.||||0.0003
73851755|NCT03306433|147251027|EQUIVALENCE|Null hypothesis was that there were no differences between the groups|Paired difference t-test|-7.412|STANDARD_DEVIATION|6.049||0.0063|TWO_SIDED|||||Paired differrnce between UDMA-K18 and UDMA control|Paired difference test, 2 sided||There are 9 participant pairs for this comparison|Paired comparison||||0.0063
73851756|NCT03306433|147251028|EQUIVALENCE|The Null hypothesis was that there would be no differences between the groups|Chi Square on WSL Index frequency|15.77||||0.0033|TWO_SIDED||||||Chi-squared|||WSL Index is non-parametric||||0.0033
73851757|NCT03306433|147251028|EQUIVALENCE|The null hypothesis was that there would not be any differences between the groups|Chi Square on WSL Index frequency|6.8321||||0.145|TWO_SIDED||||||Chi-squared|||||||0.1450
73851758|NCT01597908|147251029|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.58|0.83|||||Hazard ratios are estimated using a Pike estimator.|||0.83|0.58|
73851759|NCT01597908|147251030|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.52|0.73|||||Hazard ratios are estimated using a Pike estimator.|||0.73|0.52|
73851760|NCT01597908|147251032|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.51|0.81||||||||0.81|0.51|
73961888|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||ANOVA|||Role physical domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.008
73851761|NCT02978157|147251043|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73961889|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Role physical domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
73961890|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||ANOVA|||Bodily pain domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.002
73902105|NCT02751931|147334363|OTHER||Mean Difference (Net)|18.13||||0.113|TWO_SIDED|95.0|-4.5|40.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.7|-4.5|0.113
73902106|NCT02751931|147334363|OTHER||Mean Difference (Net)|35.58||||0.056|TWO_SIDED|95.0|-1.1|72.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||72.2|-1.1|0.056
73902107|NCT02751931|147334363|OTHER||Mean Difference (Net)|37.71||||0.005|TWO_SIDED|95.0|11.7|63.7|||t-test, 2 sided|From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.||Change From Baseline at Week 4 - Children||63.7|11.7|0.005
73902108|NCT02751931|147334363|OTHER||Mean Difference (Net)|70.35||||0.006|TWO_SIDED|95.0|22.2|118.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||118.5|22.2|0.006
73902109|NCT02751931|147334363|OTHER||Mean Difference (Net)|43.91|||<|0.001|TWO_SIDED|95.0|21.0|66.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||66.8|21.0|<0.001
73902110|NCT02751931|147334363|OTHER||Mean Difference (Net)|38.11||||0.063|TWO_SIDED|95.0|-2.2|78.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||78.4|-2.2|0.063
73902111|NCT02751931|147334363|OTHER||Mean Difference (Net)|29.05||||0.008|TWO_SIDED|95.0|8.2|49.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||49.9|8.2|0.008
73902112|NCT02751931|147334363|OTHER||Mean Difference (Net)|43.04||||0.009|TWO_SIDED|95.0|11.9|74.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||74.2|11.9|0.009
73902113|NCT02751931|147334363|OTHER||Mean Difference (Net)|44.2||||0.006|TWO_SIDED|95.0|13.2|75.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||75.2|13.2|0.006
73902114|NCT02751931|147334363|OTHER||Mean Difference (Net)|81.37||||0.003|TWO_SIDED|95.0|30.4|132.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||132.3|30.4|0.003
73902115|NCT02751931|147334363|OTHER||Mean Difference (Net)|58.49||||0.004|TWO_SIDED|95.0|19.8|97.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||97.2|19.8|0.004
73961891|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Bodily pain domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
73902116|NCT02751931|147334363|OTHER||Mean Difference (Net)|50.9||||0.039|TWO_SIDED|95.0|2.7|99.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||99.1|2.7|0.039
73902117|NCT02751931|147334363|OTHER||Mean Difference (Net)|53.76||||0.002|TWO_SIDED|95.0|21.7|85.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||85.8|21.7|0.002
73851762|NCT00654745|147251056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.9|||<|0.0001|TWO_SIDED|95.0|-21.5|-18.4|||t-test, 2 sided|||||-18.4|-21.5|<0.0001
73902118|NCT02751931|147334363|OTHER||Mean Difference (Net)|49.13||||0.057|TWO_SIDED|95.0|-1.6|99.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||99.8|-1.6|0.057
73902119|NCT02751931|147334364|OTHER||Mean Difference (Net)|7.98||||0.617|TWO_SIDED|95.0|-24.0|40.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.0|-24.0|0.617
73902120|NCT02751931|147334364|OTHER||Mean Difference (Net)|39.52||||0.035|TWO_SIDED|95.0|3.0|76.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||76.0|3.0|0.035
73902121|NCT02751931|147334364|OTHER||Mean Difference (Net)|19.81||||0.167|TWO_SIDED|95.0|-8.7|48.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||48.3|-8.7|0.167
73902122|NCT02751931|147334364|OTHER||Mean Difference (Net)|75.25||||0.005|TWO_SIDED|95.0|25.8|124.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||124.7|25.8|0.005
73902123|NCT02751931|147334364|OTHER||Mean Difference (Net)|34.01||||0.02|TWO_SIDED|95.0|5.7|62.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||62.3|5.7|0.020
73851763|NCT00654745|147251057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.0001|TWO_SIDED|95.0|-12.2|-10.3||24-hour mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.3|-12.2|<0.0001
73851764|NCT00654745|147251057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.7|||<|0.0001|TWO_SIDED|95.0|-12.9|-10.5||daytime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.5|-12.9|<0.0001
73902124|NCT02751931|147334364|OTHER||Mean Difference (Net)|44.43||||0.033|TWO_SIDED|95.0|3.9|84.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||84.9|3.9|0.033
73851765|NCT00654745|147251057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.4|||<|0.0001|TWO_SIDED|95.0|-11.7|-9.0||nighttime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.0|-11.7|<0.0001
73851766|NCT00654745|147251057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.9|||<|0.0001|TWO_SIDED|95.0|-12.2|-9.7||last 6 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.7|-12.2|<0.0001
73851767|NCT00654745|147251057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.1|||<|0.0001|TWO_SIDED|95.0|-12.4|-9.8||last 4 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.8|-12.4|<0.0001
73851768|NCT00654745|147251057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|||<|0.0001|TWO_SIDED|95.0|-13.1|-10.0||last 2 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.0|-13.1|<0.0001
73851769|NCT00654745|147251058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.8|||<|0.0001|TWO_SIDED|95.0|-22.6|-18.9||daytime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-18.9|-22.6|<0.0001
73851770|NCT00654745|147251058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.5|||<|0.0001|TWO_SIDED|95.0|-20.4|-16.6||nighttime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-16.6|-20.4|<0.0001
73851771|NCT00654745|147251058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.9|||<|0.0001|TWO_SIDED|95.0|-20.7|-17.0||last 6 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.0|-20.7|<0.0001
73851772|NCT00654745|147251058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.1|||<|0.0001|TWO_SIDED|95.0|-21.1|-17.1||last 4 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.1|-21.1|<0.0001
73851773|NCT00654745|147251058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.5|||<|0.0001|TWO_SIDED|95.0|-21.7|-17.4||last 2 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.4|-21.7|<0.0001
73851774|NCT00654745|147251059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3|||<|0.0001|TWO_SIDED|95.0|-12.0|-8.6||Change in mean seated systolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-8.6|-12.0|<0.0001
73851775|NCT00654745|147251059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.9|||<|0.0001|TWO_SIDED|95.0|-19.8|-16.1||Change in mean seated systolic blood pressure from baseline to week 6.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-16.1|-19.8|<0.0001
73902125|NCT02751931|147334364|OTHER||Mean Difference (Net)|8.68||||0.503|TWO_SIDED|95.0|-17.3|34.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0|t-test, 2 sided|||Change From Baseline at Week 12 - Children||34.7|-17.3|0.503
73902126|NCT02751931|147334364|OTHER||Mean Difference (Net)|38.23||||0.016|TWO_SIDED|95.0|7.8|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||68.6|7.8|0.016
73902127|NCT02751931|147334364|OTHER||Mean Difference (Net)|40.76||||0.043|TWO_SIDED|95.0|1.4|80.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||80.2|1.4|0.043
73902128|NCT02751931|147334364|OTHER||Mean Difference (Net)|86.66|||<|0.001|TWO_SIDED|95.0|41.5|131.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||131.8|41.5|<0.001
73902129|NCT02751931|147334364|OTHER||Mean Difference (Net)|31.08||||0.203|TWO_SIDED|95.0|-17.5|79.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||79.6|-17.5|0.203
73902130|NCT02751931|147334364|OTHER||Mean Difference (Net)|68.47||||0.019|TWO_SIDED|95.0|12.7|124.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||124.2|12.7|0.019
73902131|NCT02751931|147334364|OTHER||Mean Difference (Net)|31.83||||0.042|TWO_SIDED|95.0|1.3|62.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||62.4|1.3|0.042
73851776|NCT00654745|147251059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.0|||<|0.0001|TWO_SIDED|95.0|-22.2|-17.8||Change in mean seated systolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.8|-22.2|<0.0001
73851777|NCT00654745|147251059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.7|||<|0.0001|TWO_SIDED|95.0|-25.7|-21.7||Change in mean seated systolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-21.7|-25.7|<0.0001
73851778|NCT00654745|147251059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.5|||<|0.0001|TWO_SIDED|95.0|-30.8|-26.2||Change in mean seated systolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-26.2|-30.8|<0.0001
73851779|NCT00654745|147251059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.1|||<|0.0001|TWO_SIDED|95.0|-33.3|-28.8||Change in mean seated systolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-28.8|-33.3|<0.0001
73851780|NCT00654745|147251060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.1||Change in mean seated diastolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-3.1|-5.1|<0.0001
73851781|NCT00654745|147251060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.2|||<|0.0001|TWO_SIDED|95.0|-9.4|-7.1||Change in mean seated diastolic blood pressure from baseline to week 6|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-7.1|-9.4|<0.0001
73851782|NCT00654745|147251060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.7|||<|0.0001|TWO_SIDED|95.0|-10.9|-8.4||Change in mean seated diastolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-8.4|-10.9|<0.0001
73851783|NCT00654745|147251060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.0001|TWO_SIDED|95.0|-12.5|-9.9||Change in mean seated diastolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.9|-12.5|<0.0001
73851784|NCT00654745|147251060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.4|||<|0.0001|TWO_SIDED|95.0|-15.7|-13.1||Change in mean seated diastolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-13.1|-15.7|<0.0001
73902132|NCT02751931|147334364|OTHER||Mean Difference (Net)|38.14||||0.121|TWO_SIDED|95.0|-11.0|87.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||87.3|-11.0|0.121
73902133|NCT02751931|147334365|OTHER||Mean Difference (Net)|0.35||||0.818|TWO_SIDED|95.0|-2.7|3.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||3.4|-2.7|0.818
74084763|NCT02418754|147722931|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.|Least Squares (LS) Mean Difference|-1.58||||0.2052|TWO_SIDED|95.0|-4.37|1.22||Threshold for significance at 0.025 level.|ANCOVA|||To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.||1.22|-4.37|0.2052
73902134|NCT02751931|147334365|OTHER||Mean Difference (Net)|-0.53||||0.114|TWO_SIDED|95.0|-1.2|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||0.1|-1.2|0.114
73902135|NCT02751931|147334365|OTHER||Mean Difference (Net)|-1.14||||0.052|TWO_SIDED|95.0|-2.3|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||0.0|-2.3|0.052
73902136|NCT02751931|147334365|OTHER||Mean Difference (Net)|-0.87||||0.066|TWO_SIDED|95.0|-1.8|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||0.1|-1.8|0.066
73961892|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.077|TWO_SIDED||||||ANOVA|||General health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.077
73851785|NCT00654745|147251060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.1|||<|0.0001|TWO_SIDED|95.0|-16.5|-13.6||Change in mean seated diastolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-13.6|-16.5|<0.0001
73851786|NCT00924612|147251154|OTHER||Odds Ratio, log|130.83|STANDARD_ERROR_OF_MEAN|0.0844||0.0025|TWO_SIDED|90.0|113.59|150.7|||t-test, 2 sided|||Comparison of diets based on full crossover model|ANOVA of a multicenter, 4 sequence, 5 treatment crossover model using ln-transformed data. Normal fat diet compared to fasting, very low fat, low fat, and high fat diets as part of the overall analysis. No adjustments for multiplicity made.|150.70|113.59|0.0025
73851787|NCT00924612|147251154|OTHER||Odds Ratio, log|101.84|STANDARD_ERROR_OF_MEAN|0.0954||0.8494|TWO_SIDED|90.0|86.8|119.47|||t-test, 2 sided|||Comparison of diets based on full crossover model||119.47|86.80|0.8494
73851788|NCT00924612|147251154|OTHER||Odds Ratio, log|73.55|STANDARD_ERROR_OF_MEAN|0.0902||0.0013|TWO_SIDED|90.0|63.23|85.55|||t-test, 2 sided|||Comparison of diets based on full crossover model||85.55|63.23|0.0013
73851789|NCT00924612|147251154|OTHER||Odds Ratio, log|62.62|STANDARD_ERROR_OF_MEAN|0.0954|<|0.0001|TWO_SIDED|90.0|53.38|76.46|||t-test, 2 sided|||Comparison of diets based on full crossover model||76.46|53.38|<0.0001
73851790|NCT02229825|147251158|OTHER|||||||0.88||||||p-value for treatment effect|ANCOVA|ANCOVA with stratification factors (country and pretreatment) and baseline score and treatment as the main factor.||The null hypothesis was that the mean change in MADRS total score between week 4 and baseline was the same for the 2 duloxetine treatment groups.||||0.88
73851791|NCT02229825|147251159|OTHER|||||||0.86||||||Treatment effect.|ANCOVA|Analysis of covariance (ANCOVA) with stratification factors and HAMD6 baseline as covariates and treatment regimen as main factor.||Comparison between treatment regimes at Week 4.||||0.86
73851792|NCT02229825|147251160|OTHER||||||<|0.0001|||||||Signed Rank test|||Within-group comparisons, week 8 versus baseline.||||<0.0001
73851793|NCT02229825|147251160|OTHER||||||<|0.0001|||||||Singed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
73851794|NCT02229825|147251160|OTHER||||||<|0.0001|||||||Singed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
73851795|NCT02229825|147251160|OTHER||||||<|0.0001|||||||Signed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
73851796|NCT02229825|147251162|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
73851797|NCT02229825|147251162|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
73851798|NCT02229825|147251162|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
73851799|NCT02229825|147251162|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
73851800|NCT02229825|147251163|OTHER|||||||0.32||||||Treatment effect.|Regression, Logistic|||Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.||||0.32
73851801|NCT02229825|147251165|OTHER|||||||0.57||||||Treatment effect.|Regression, Logistic|||Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.||||0.57
73851802|NCT02229825|147251168|OTHER|||||||0.68|||||||Cochran-Mantel-Haenszel|Stratified by country, 60 mg vs. 120 mg||"At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||0.68
73851803|NCT02229825|147251169|OTHER||Statistic|-528.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
73851804|NCT02229825|147251169|OTHER||Statistic|-540.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
73851805|NCT02229825|147251169|OTHER||Statistic|-1024.5|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
73851806|NCT02229825|147251169|OTHER||Statistic|-279.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
73851807|NCT02229825|147251170|OTHER|No formal hypothesis was tested.||||||0.07||||||Stratified by country, 60 mg vs. 120 mg|Cochran-Mantel-Haenszel|||"At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||0.07
73851808|NCT02229825|147251172|OTHER||CMH statistic|0.0||||1|||||||Cochran-Mantel-Haenszel|||"Before testing, PGI-I items were pooled to reduce the possible number of classes. The 3 classes used (instead of 7 items) were: 1-2= improved, 3-5=Stable, 6-7=Worsened. At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||1.00
73851809|NCT02229825|147251174|OTHER|||||||0.92||||||Treatment effect|ANCOVA|||Comparison between HAMA scores between treatment regimens.||||0.92
73851810|NCT02229825|147251175|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
73851811|NCT02229825|147251175|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
73851812|NCT02229825|147251175|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
73851813|NCT02229825|147251175|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
73961893|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||ANOVA|||General health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.068
74024405|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.39|-0.32|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.39|0.002
74024406|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.96|-0.9|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.90|-1.96|<0.001
73851814|NCT02229825|147251177|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, Week 8 versus baseline.||||<0.0001
73851815|NCT02229825|147251177|OTHER|||||||0.001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||0.001
73851816|NCT02229825|147251177|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
73851817|NCT02229825|147251177|OTHER|||||||0.28|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||0.28
73902137|NCT02751931|147334365|OTHER||Mean Difference (Net)|1.16||||0.674|TWO_SIDED|95.0|-4.4|6.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||6.7|-4.4|0.674
73902138|NCT02751931|147334365|OTHER||Mean Difference (Net)|-0.65||||0.278|TWO_SIDED|95.0|-1.9|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||0.6|-1.9|0.278
73902139|NCT02751931|147334365|OTHER||Mean Difference (Net)|0.37||||0.871|TWO_SIDED|95.0|-4.2|5.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||5.0|-4.2|0.871
73902140|NCT02751931|147334365|OTHER||Mean Difference (Net)|-0.65||||0.153|TWO_SIDED|95.0|-1.6|0.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||0.3|-1.6|0.153
73902141|NCT02751931|147334365|OTHER||Mean Difference (Net)|0.18||||0.922|TWO_SIDED|95.0|-3.5|3.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||3.9|-3.5|0.922
73902142|NCT02751931|147334365|OTHER||Mean Difference (Net)|-0.75||||0.047|TWO_SIDED|95.0|-1.5|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||0.0|-1.5|0.047
73902143|NCT02751931|147334365|OTHER||Mean Difference (Net)|-1.98||||0.018|TWO_SIDED|95.0|-3.6|-0.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||-0.4|-3.6|0.018
73902144|NCT02751931|147334365|OTHER||Mean Difference (Net)|-0.81||||0.07|TWO_SIDED|95.0|-1.7|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||0.1|-1.7|0.070
73902145|NCT02751931|147334365|OTHER||Mean Difference (Net)|-0.94||||0.083|TWO_SIDED|95.0|-2.0|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||0.1|-2.0|0.083
74024407|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.28||0.085|TWO_SIDED|95.0|-1.03|0.07|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.07|-1.03|0.085
73902146|NCT02751931|147334365|OTHER||Mean Difference (Net)|-1.12||||0.064|TWO_SIDED|95.0|-2.3|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||0.1|-2.3|0.064
73902147|NCT02751931|147334366|OTHER|||||||0.692||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||||0.692
74024408|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.28||0.026|TWO_SIDED|95.0|-1.18|-0.08|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-1.18|0.026
73851818|NCT00104416|147251184|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|31.6|||<|0.0001||95.0|15.8|48.1|||Cochran-Mantel-Haenszel|||||48.1|15.8|<0.0001
73851819|NCT01309997|147251207|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73851820|NCT01309997|147251207|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
73902148|NCT02751931|147334366|OTHER|||||||0.018||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||||0.018
73902149|NCT02751931|147334366|OTHER|||||||0.061||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||||0.061
73902150|NCT02751931|147334366|OTHER|||||||0.008||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||||0.008
73902151|NCT02751931|147334366|OTHER|||||||0.612||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||||0.612
73851821|NCT04343534|147251208|OTHER||Mean Difference (Final Values)|0.15||||0.092|TWO_SIDED|95.0|-0.02|0.33|||t-test, 2 sided|||"SDM Process score distributions were compared to determine of the scores spanned the range of possible values, were normally distributed, had low rates of missing data, and whether there was indications of floor or ceiling effects.~we conducted independent t-tests to determine if there were differences in SDM Process scores between the two versions."||0.33|-0.02|0.092
73851822|NCT03462641|147251217|SUPERIORITY||t-value|-2.15|STANDARD_DEVIATION|1.32||0.0407|TWO_SIDED|||||Alpha was set to 0.05.|Paired-Sample Two-Tailed T-Test|||Null hypothesis was no difference in PIGD score within participants before and after flumazenil infusion.||||0.0407
74024409|NCT00733902|147600903|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.94|-0.84|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.84|-1.94|<0.001
73851823|NCT03462641|147251217|OTHER||F-value|2.861||||0.103|TWO_SIDED|||||"P value is given for the Drug\*Time term, which represents interaction between time relative to administration (before infusion vs after infusion) and treatment administered (placebo vs flumazenil).~Alpha was set to 0.05."|Repeated Measures ANCOVA|||Null hypothesis is that there is no significant interaction between drug and time of administration (pre vs. post infusion).||||0.103
73851824|NCT03462641|147251218|OTHER||Standardized β Coefficient|0.6||||2.9e-07|TWO_SIDED|95.0|0.13|1.07||P value presented is for model comparison between interaction model and random intercept model.|Mixed Models Analysis|||A pair of maximum likelihood mixed linear models were estimated. The first was a random intercept model that merely accounted for individual differences in PIGD score before infusion. The second was an interaction model, that added an interaction term between baseline FMZ PET binding and PIGD score change from pre to post infusion. The interaction model was compared against the random intercept model to determine significance of the interaction using likelihood ratio goodness of fit test.||1.07|0.13|0.00000029
73851825|NCT04301934|147251236|NON_INFERIORITY|The prevalence of UTI for the LASER group and vaginal estrogen group was calculated. Non-inferiority test using Farrington-Manning method was applied to test the risk difference against the pre-specified non-inferiority margin (20%).||||||0.034|||||||Farrington-Manning|||||||0.034
73851826|NCT04660552|147251277|EQUIVALENCE|The post treatment cars scores of active and sham group will be statistically different as measured by independent sample t-test with p\<.05|Mean Difference (Net)|7.23|STANDARD_DEVIATION|4.2||0.01|TWO_SIDED|95.0|2.357|12.107|||t-test, 2 sided|||||12.107|2.357|0.01
73851827|NCT02091362|147251285|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.11|3.4|||Mixed Models Analysis|||||3.40|1.11|<.001
73851828|NCT02091362|147251286|SUPERIORITY_OR_OTHER||LS Mean Difference|1.37|||<|0.01|TWO_SIDED|95.0|0.66|2.08|||Mixed Models Analysis|||||2.08|0.66|<0.01
73851829|NCT00617097|147251303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.94|TWO_SIDED|95.0|-13.7|12.6|||Regression, Linear|||expected level of pain during procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||12.6|-13.7|0.94
73851830|NCT00617097|147251303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.9|TWO_SIDED|95.0|-15.1|13.2|||Regression, Linear|||after speculum insertion greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||13.2|-15.1|0.9
73851831|NCT00617097|147251303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.49|TWO_SIDED|95.0|-18.6|9.0|||Regression, Linear|||during paracervical block administration greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||9|-18.6|0.49
73851832|NCT00617097|147251303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0||||0.03|TWO_SIDED|95.0|-28.3|-1.7|||Regression, Linear|||after cervical dilation greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||-1.7|-28.3|0.03
73851833|NCT00617097|147251303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.7|TWO_SIDED|95.0|-12.2|18.0|||Regression, Linear|||immediately after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||18|-12.2|0.7
73851834|NCT00617097|147251303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.52|TWO_SIDED|95.0|-17.0|8.8|||Regression, Linear|||30 min after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||8.8|-17|.52
73851835|NCT00617097|147251304|SUPERIORITY_OR_OTHER|||||||0.93|||||||Regression, Linear|||greater number is better (i.e., more satisfaction) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less satisfaction); maximum: 100 mm (greater satisfaction) Measured at end of study (i.e., upon clinic discharge)||||0.93
73851836|NCT00617097|147251305|SUPERIORITY_OR_OTHER|||||||0.07|||||||Chi-squared|||greater number is worse (i.e., more symptoms)||||0.07
73851837|NCT00617097|147251306|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||minor complications greater number is worse (i.e., more complications)||||1
73851838|NCT00617097|147251306|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||serious complications||||0.15
73851839|NCT05319899|147251307|OTHER||Geometric Mean Ratio (%)|140.63|||||TWO_SIDED|90.0|118.94|166.26||||||Analysis was performed using analysis of variance (ANOVA).||166.26|118.94|
73851840|NCT05319899|147251307|OTHER||Geometric Mean Ratio (%)|77.65|||||TWO_SIDED|90.0|65.67|91.8||||||Analysis was performed using ANOVA.||91.80|65.67|
73851841|NCT05319899|147251308|OTHER||Geometric Mean Ratio (%)|128.23|||||TWO_SIDED|90.0|112.99|145.52||||||Analysis was performed using ANOVA.||145.52|112.99|
73851842|NCT05319899|147251308|OTHER||Geometric Mean Ratio (%)|95.94|||||TWO_SIDED|90.0|84.54|108.88||||||Analysis was performed using ANOVA.||108.88|84.54|
73902152|NCT02751931|147334366|OTHER|||||||0.018||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||||0.018
73851843|NCT00289289|147251386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|4.8||0.629|ONE_SIDED|95.0||0.5||P-value is from a paired t-test since each subject had the intervention pacing features turned ON and OFF in this crossover study|t-test, 1 sided|One-sided paired t-test with 221 degrees of freedom|A mean difference greater than zero indicates an average increase in atrial fibrillation/atrial tachycardia symptomatic episodes while the intervention pacing features were programmed ON versus OFF.|Null Hypothesis: rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods when intervention pacing features ON is greater to or equal to the rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods where intervention pacing features were programmed OFF Alternative Hypothesis: rate of symptomatic AT/AF during periods of ON programming is less than the rate of symptomatic AT/AF during OFF programming||0.5||0.629
73851844|NCT00289289|147251387|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.165|||||||Wilcoxon (Mann-Whitney)|P-value is from Koch's adaptation to the Wilcoxon Rank-Sum test comparing the within subject ON minus OFF differences to 0|A negative change means an improvement in AF symptom frequency with intervention pacing therapy programmed ON. Total possible improvement while intervention features are programmed ON is -64. Total possible worsening during ON programming is 64.|"The null hypothesis is that the symptom frequency score does not differ between while intervention pacing features were programmed ON versus OFF.~This secondary objective was not powered."||||0.165
73851845|NCT00289289|147251388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.603|TWO_SIDED|95.0|0.39|1.73||P-value is based on a repeated measures Cox proportional hazards model to the rate of AF cardioversion attempts between periods of ON and OFF programming|Regression, Cox||Hazard Ratio compares rate of first attempted cardioversion for AF while the intervention pacing features were programmed ON versus OFF.|"Null Hypothesis: AF Cardioversion attempt rate is the same during periods of ON and OFF programming~Alternative Hypothesis: AF Cardioversion attempt rate is different during periods of ON and OFF programming"||1.73|0.39|0.603
73851846|NCT00289289|147251389|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.394||95.0||||Within each randomized subject, the ON minus OFF difference in AT/AF burden was computed. The Wilcoxon Signed-Rank test was used to determine if the ON minus OFF difference in AT/AF burden was different from zero.|Wilcoxon (Mann-Whitney)||A negative median difference represents an improvement (lessening) of AT/AF burden during periods of ON versus OFF programming. A positive median difference represents an increase in AT/AF burden during ON compared to OFF programming.|Null Hypothesis: There is no difference in AT/AF burden during periods on ON and OFF programming Alternative Hypothesis: AT/AF burden is lower during periods of ON programming compared to periods of OFF programming||||0.394
73851847|NCT00349349|147251428|SUPERIORITY_OR_OTHER||percentage of responders|0.49|||<|0.0001|TWO_SIDED|95.3|0.39|0.6||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.60|0.39|<0.0001
73851848|NCT00349349|147251428|SUPERIORITY_OR_OTHER||percentage of responders|0.43|||<|0.0001|TWO_SIDED|95.3|0.33|0.53||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.53|0.33|<0.0001
73851849|NCT00349349|147251428|SUPERIORITY_OR_OTHER||percentage of responders|0.63|||<|0.001|TWO_SIDED|95.3|0.35|0.85||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.85|0.35|<0.001
73851850|NCT04776720|147251541|SUPERIORITY||Model based LS mean difference|0.19||||0.743|TWO_SIDED|95.0|-0.95|1.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.34|-0.95|0.743
73851851|NCT04776720|147251542|SUPERIORITY||Model based LS mean difference|0.98||||0.043|TWO_SIDED|95.0|0.03|1.93|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.93|0.03|0.043
73851852|NCT04776720|147251543|SUPERIORITY||Model based LS mean difference|0.99||||0.689|TWO_SIDED|95.0|-3.87|5.84|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with variance co-variance matrix||||5.84|-3.87|0.689
73851853|NCT04776720|147251544|SUPERIORITY||Model based LS mean difference|-0.28||||0.685|TWO_SIDED|95.0|-1.63|1.07|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.07|-1.63|0.685
73851854|NCT04776720|147251545|SUPERIORITY||Model based LS mean difference|0.3||||0.764|TWO_SIDED|95.0|-1.69|2.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.3|-1.69|0.764
73851855|NCT04776720|147251546|SUPERIORITY||Model based LS mean difference|-0.12||||0.883|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.53|-1.78|0.883
73851856|NCT04776720|147251547|SUPERIORITY||Model based LS mean difference|-0.11||||0.753|TWO_SIDED|95.0|-0.83|0.6|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.6|-0.83|0.753
73851857|NCT04776720|147251548|SUPERIORITY||Model based LS mean difference|-3.4||||0.276|TWO_SIDED|95.0|-9.54|2.74|||Mixed Models Analysis|Adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.74|-9.54|0.276
73851858|NCT04776720|147251549|SUPERIORITY||Model based LS mean difference|-0.29||||0.319|TWO_SIDED|95.0|-0.86|0.28|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.28|-0.86|0.319
73851859|NCT04776720|147251550|SUPERIORITY||Model based LS mean difference|0.1||||0.448|TWO_SIDED|95.0|-0.15|0.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.34|-0.15|0.448
73902153|NCT02751931|147334366|OTHER|||||||0.858||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||||0.858
73902154|NCT02751931|147334366|OTHER|||||||0.004||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||||0.004
73902155|NCT02751931|147334366|OTHER|||||||0.003||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||||0.003
73902156|NCT02751931|147334366|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||||< 0.001
73902157|NCT02751931|147334366|OTHER|||||||0.045||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||||0.045
73902158|NCT02751931|147334366|OTHER|||||||0.002||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||||0.002
73902159|NCT02751931|147334366|OTHER|||||||0.006||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||||0.006
73902160|NCT02751931|147334366|OTHER|||||||0.007||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||||0.007
73902161|NCT02751931|147334367|OTHER||Mean Difference (Net)|0.34||||0.018|TWO_SIDED|95.0|0.1|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||0.6|0.1|0.018
74084764|NCT02418754|147722931|SUPERIORITY|Analysis was performed using ANCOVA model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.|Least Squares (LS) Mean Difference|-1.7||||0.0982|TWO_SIDED|95.0|-4.0|0.61||Threshold for significance at 0.025 level.|ANCOVA|||To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.||0.61|-4.00|0.0982
73902162|NCT02751931|147334367|OTHER||Mean Difference (Net)|0.82||||0.045|TWO_SIDED|95.0|0.0|1.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||1.6|0.0|0.045
73902163|NCT02751931|147334367|OTHER||Mean Difference (Net)|0.68||||0.013|TWO_SIDED|95.0|0.1|1.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||1.2|0.1|0.013
73902164|NCT02751931|147334367|OTHER||Mean Difference (Net)|1.36||||0.002|TWO_SIDED|95.0|0.6|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||2.2|0.6|0.002
73902165|NCT02751931|147334367|OTHER||Mean Difference (Net)|1.14||||0.001|TWO_SIDED|95.0|0.5|1.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||1.8|0.5|0.001
73902166|NCT02751931|147334367|OTHER||Mean Difference (Net)|2.26|||<|0.001|TWO_SIDED|95.0|1.2|3.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||3.3|1.2|<0.001
73902167|NCT02751931|147334367|OTHER||Mean Difference (Net)|1.31||||0.001|TWO_SIDED|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||2.1|0.5|0.001
73902168|NCT02751931|147334367|OTHER||Mean Difference (Net)|1.93|||<|0.001|TWO_SIDED|95.0|0.9|3.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||3.0|0.9|<0.001
73902169|NCT02751931|147334367|OTHER||Mean Difference (Net)|1.34|||<|0.001|TWO_SIDED|95.0|0.7|2.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||2.0|0.7|<0.001
73902170|NCT02751931|147334367|OTHER||Mean Difference (Net)|2.17|||<|0.001|TWO_SIDED|95.0|1.2|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||3.2|1.2|<0.001
73902171|NCT02751931|147334367|OTHER||Mean Difference (Net)|1.33||||0.002|TWO_SIDED|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||2.1|0.5|0.002
73902172|NCT02751931|147334367|OTHER||Mean Difference (Net)|1.88|||<|0.001|TWO_SIDED|95.0|1.0|2.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||2.8|1.0|<0.001
73902173|NCT02751931|147334367|OTHER||Mean Difference (Net)|1.38||||0.002|TWO_SIDED|95.0|0.5|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||2.2|0.5|0.002
73902174|NCT02751931|147334367|OTHER||Mean Difference (Net)|2.14|||<|0.001|TWO_SIDED|95.0|1.1|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||3.2|1.1|<0.001
73961894|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.018|TWO_SIDED||||||ANOVA|||Vitality domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.018
73902175|NCT02751931|147334368|OTHER||Mean Difference (Net)|2.04||||0.352|TWO_SIDED|95.0|-2.4|6.49||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||6.49|-2.40|0.352
73902176|NCT02751931|147334368|OTHER||Mean Difference (Net)|-4.9||||0.127|TWO_SIDED|95.0|-11.34|1.53||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||1.53|-11.34|0.127
73902177|NCT02751931|147334368|OTHER||Mean Difference (Net)|1.3||||0.613|TWO_SIDED|95.0|-3.96|6.57||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||6.57|-3.96|0.613
74084765|NCT04974580|147722939|SUPERIORITY||Odds Ratio (OR)|1.3||||0.14|TWO_SIDED|95.0|0.91|1.84||A priori threshold was 0.10|Regression, Logistic||Reported OR is NRT receipt vs. not, so values \>1 indicate higher odds of abstinence among those receiving NRT.|Comparison of NRT vs. no-NRT in model adjusted for receipt of digital component||1.84|0.91|0.14
73902178|NCT02751931|147334368|OTHER||Mean Difference (Net)|-6.79||||0.056|TWO_SIDED|95.0|-13.78|0.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||0.20|-13.78|0.056
73902179|NCT02751931|147334369|OTHER||Mean Difference (Net)|0.36||||0.153|TWO_SIDED|95.0|-0.14|0.86||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||0.86|-0.14|0.153
73902180|NCT02751931|147334369|OTHER||Mean Difference (Net)|0.64||||0.007|TWO_SIDED|95.0|0.19|1.08||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||1.08|0.19|0.007
73902181|NCT02751931|147334369|OTHER||Mean Difference (Net)|0.42||||0.106|TWO_SIDED|95.0|-0.1|0.93||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||0.93|-0.10|0.106
73902182|NCT02751931|147334369|OTHER||Mean Difference (Net)|0.95||||0.003|TWO_SIDED|95.0|0.38|1.51||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||1.51|0.38|0.003
73961895|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.053|TWO_SIDED||||||ANOVA|||Vitality domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.053
73851860|NCT01433042|147251562|SUPERIORITY_OR_OTHER||percentage|98.0||||||||||since the study results analysis is purley discriptive no P value and confidence interval was used for the analysis|percentage|percentage of SB3 images graded as superior in image quality to SB2|since the study results analysis is purley discriptive no P value and confidence interval was used for the analysis|"Primary Endpoint~o Physician's subjective assessment questionnaire was evaluated in a quality manner.~The physicians were required to assess the performance of SB3 system as compare to SB2 by answering a short questionnaire.~The physicians were requested to indicate whether capsule SB3 was better as compared to SB2."||||
73851861|NCT03122145|147251565|SUPERIORITY|Mann whitney U between groups comparison for voluntary cough parameters between healthy controls and individuals with ALS outcomes: peak expiratory cough flow and cough volume acceleration||||||0.0005|||||||ANOVA|||Hypothesis that voluntary cough \> reflex cough strength and effectiveness in healthy volunteers||||0.0005
73902183|NCT01037088|147334385|SUPERIORITY||||||>|0.05||||||not significant|Mixed Models Analysis|||Hour 1 after Administration of Cannabis||||>.05
73902184|NCT01037088|147334385|SUPERIORITY||||||=|0.0002|||||||Mixed Models Analysis|||Hour 2 after Administration of Cannabis||||=.0002
73902185|NCT01037088|147334385|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Hour 3 after Administration of Cannabis (after the second inhalation of cannabis)||||<.0001
73902186|NCT01037088|147334385|SUPERIORITY||||||=|0.0004|||||||Mixed Models Analysis|||Hour 4 after Administration of Cannabis||||=.0004
73902187|NCT01037088|147334385|SUPERIORITY||||||=|0.0018|||||||Mixed Models Analysis|||Hour 5 after Administration of Cannabis||||=.0018
73902188|NCT00266864|147334387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|2.7|<|0.01|TWO_SIDED|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 \[(month 12- baseline)/baseline\*100\] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in lean tissue mass across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.||||<0.01
73902189|NCT00266864|147334388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|101.0|STANDARD_DEVIATION|103.0||0.051|TWO_SIDED|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 \[(month 12- baseline)/baseline\*100\] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in resting energy expenditure across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.||||0.051
73902190|NCT03036800|147334389|SUPERIORITY||Odds Ratio (OR)|5.19|||<|0.001|TWO_SIDED|95.0|2.09|12.88|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.88|2.09|<0.001
73902191|NCT03036800|147334390|SUPERIORITY||Odds Ratio (OR)|5.94|||<|0.001|TWO_SIDED|95.0|2.45|14.4|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.4|2.45|<0.001
73902192|NCT03036800|147334391|SUPERIORITY||Odds Ratio (OR)|5.04||||0.002|TWO_SIDED|95.0|1.81|14.01|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.01|1.81|0.002
73961896|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||ANOVA|||Social functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.002
73851862|NCT04114071|147251572|EQUIVALENCE|An independent sample t tests was used to examine the difference score for each of the four outcome measures of interest (steps, WC, weight, and HbA1c) between intervention and control groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73851863|NCT01659996|147251573|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% confidence interval (CI) of the difference between the two proportions was \< δ for serogroup A and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.11|||||TWO_SIDED|95.0|-3.11|2.93||||||Meningococcal serogroup A: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||2.93|-3.11|
73902193|NCT03036800|147334392|SUPERIORITY||Odds Ratio (OR)|5.24||||0.002|TWO_SIDED|95.0|1.88|14.64|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.64|1.88|0.002
73902194|NCT03036800|147334409|SUPERIORITY||Odds Ratio (OR)|10.12|||<|0.001|TWO_SIDED|95.0|5.26|19.48|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||19.48|5.26|<0.001
73902195|NCT03036800|147334410|SUPERIORITY||Odds Ratio (OR)|5.17|||<|0.001|TWO_SIDED|95.0|2.86|9.36|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||9.36|2.86|<0.001
73961897|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||ANOVA|||Social functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.003
73961898|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||ANOVA|||Role emotional domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.015
73961899|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.154|TWO_SIDED||||||ANOVA|||Role emotional domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.154
73961900|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.024|TWO_SIDED||||||ANOVA|||Mental health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.024
73961901|NCT02507752|147460403|SUPERIORITY_OR_OTHER||||||=|0.029|TWO_SIDED||||||ANOVA|||Mental health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.029
73961902|NCT03811574|147460413|SUPERIORITY||Treatment difference|-7.52|||<|0.0001|TWO_SIDED|95.0|-9.62|-5.43|||ANCOVA|||Treatment policy estimand||-5.43|-9.62|<.0001
73961903|NCT03811574|147460413|SUPERIORITY||Treatment difference|-11.06|||<|0.0001|TWO_SIDED|95.0|-12.88|-9.24|||ANCOVA|||Treatment policy estimand||-9.24|-12.88|<.0001
73961904|NCT03811574|147460414|SUPERIORITY||Odds Ratio (OR)|11.08|||<|0.0001|TWO_SIDED|95.0|5.53|22.22|||Regression, Logistic|||Treatment policy estimand||22.22|5.53|<.0001
74024410|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-0.49|<0.001
73851864|NCT01659996|147251573|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup C and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.27|||||TWO_SIDED|95.0|-0.84|3.64||||||Meningococcal serogroup C: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||3.64|-0.84|
73851865|NCT01659996|147251573|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup Y and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|2.46|||||TWO_SIDED|95.0|0.14|5.14||||||Meningococcal serogroup Y: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||5.14|0.14|
73851866|NCT01659996|147251573|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup W-135 and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.28|||||TWO_SIDED|95.0|-0.84|3.67||||||Meningococcal serogroup W-135: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||3.67|-0.84|
73851867|NCT01659996|147251578|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.949|||||TWO_SIDED|95.0|0.852|1.06||||||Pertussis toxoid (PT): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PT) in Group 3 and in Group 2, respectively||1.06|0.852|
73902196|NCT03036800|147334411|SUPERIORITY||Odds Ratio (OR)|4.16|||<|0.001|TWO_SIDED|95.0|2.39|7.22|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||7.22|2.39|<0.001
73902197|NCT03036800|147334412|SUPERIORITY||Odds Ratio (OR)|2.44||||0.01|TWO_SIDED|95.0|1.23|4.84|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.84|1.23|0.010
73902198|NCT03036800|147334413|SUPERIORITY||Odds Ratio (OR)|5.14|||<|0.001|TWO_SIDED|95.0|2.14|12.39|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.39|2.14|<0.001
73961905|NCT03811574|147460414|SUPERIORITY||Odds Ratio (OR)|21.72|||<|0.0001|TWO_SIDED|95.0|11.27|41.86|||Regression, Logistic|||Treatment policy estimand||41.86|11.27|<.0001
73961906|NCT00940537|147460459|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||a priori threshhold for significance was set at p\<0.05.|t-test, 2 sided|this was a paired t-test||As there was no a priori reason for the level of IHTG to impact this measurement we compared the pre and post-prandial results for all subjects whose data were of sufficient quality (N=12). These results are comparing the two categories of fasting and post-prandial. Null hypothesis was that there would be no difference in IHTG before and after a high fat, high carbohydrate meal.||||.097
73961907|NCT00940537|147460460|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||This p-value compares the low IHTG (\<5%) subjects to those with medium levels of IHTG (5 - 10%). The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intrahepatic triglyceride (IHTG) and would be equal for the low and medium IHTG categories.||||0.006
73961908|NCT00940537|147460460|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intra-hepatic triglyceride (IHTG) and would be equal for the low (\<5%) and high (\>10%) IHTG categories.||||<0.0001
74024411|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.486|TWO_SIDED|95.0|-0.24|0.11|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.11|-0.24|0.486
73961909|NCT00940537|147460460|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||The a priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that there would be no difference in T2 relaxation ratios for varying levels of intra-hepatic triglyceride (IHTG). Thus the medium (5 - 10%) and high (\<10%) IHTG groups would not be statistically different with regard to average T2 ratio.||||.93
73961910|NCT00736853|147460465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.377||||0.0001|TWO_SIDED|95.0|0.221|0.641|||Log Rank|Stratified Log-rank test with the target disease as the stratification factor||||0.641|0.221|0.0001
74084766|NCT04974580|147722939|SUPERIORITY||Odds Ratio (OR)|1.04||||0.84|TWO_SIDED|95.0|0.73|1.47||A priori threshold was 0.10|Regression, Logistic||Reported OR is Digital receipt vs. not, so values \>1 indicate higher odds of abstinence among those receiving the Digital component.|Comparison of Digital vs. no Digital in model adjusted for receipt of NRT component||1.47|0.73|0.84
73851868|NCT01659996|147251578|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.968|||||TWO_SIDED|95.0|0.866|1.08||||||Filamentous hemagglutinin (FHA): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (FHA) in Group 3 and in Group 2, respectively||1.08|0.866|
73851869|NCT01659996|147251578|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|1.11|||||TWO_SIDED|95.0|0.937|1.31||||||Pertactin (PRN): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PRN) in Group 3 and in Group 2, respectively||1.31|0.937|
73851870|NCT01659996|147251579|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-1.22|||||TWO_SIDED|95.0|-5.44|3.19||||||Pertussis toxoid (PT) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PT), with δ = 0.10.||3.19|-5.44|
73851871|NCT01659996|147251579|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|0.867|||||TWO_SIDED|95.0|-2.54|4.53||||||Filamentous hemagglutinin (FHA) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (FHA), with δ = 0.10.||4.53|-2.54|
73851872|NCT01659996|147251579|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.092|||||TWO_SIDED|95.0|-3.62|3.66||||||Pertactin (PRN) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PRN), with δ = 0.10.||3.66|-3.62|
73851873|NCT06899737|147251615|SUPERIORITY||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|2.56||0.32|TWO_SIDED|95.0|-7.64|2.55|||t-test, 2 sided|||||2.55|-7.64|0.32
73851874|NCT06899737|147251616|SUPERIORITY||Mean Difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|3.08||0.18|TWO_SIDED|95.0|-1.94|10.3|||t-test, 2 sided|||||10.30|-1.94|0.18
73851875|NCT06899737|147251617|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.5||0.71|TWO_SIDED|95.0|-0.81|1.18|||t-test, 2 sided|||||1.18|-0.81|0.71
73851876|NCT06899737|147251618|SUPERIORITY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.32||0.32|TWO_SIDED|95.0|-0.03|1.24|||t-test, 2 sided|||||1.24|-0.03|0.32
73851877|NCT06899737|147251619|SUPERIORITY||Median Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.44||0.91|TWO_SIDED|95.0|-0.82|0.92|||t-test, 2 sided|||||0.92|-0.82|0.91
73851878|NCT06899737|147251620|SUPERIORITY||Median Difference (Final Values)|0.69||||0.059|TWO_SIDED|95.0|-0.03|1.42|||t-test, 2 sided|||||1.42|-0.03|0.059
73851879|NCT06899737|147251621|SUPERIORITY||Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.41||0.79|TWO_SIDED|95.0|-0.92|0.71|||t-test, 2 sided|||||0.71|-0.92|0.79
73851880|NCT06899737|147251622|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.33||0.14|TWO_SIDED|95.0|-0.16|1.15|||t-test, 2 sided|||||1.15|-0.16|0.14
73851881|NCT06899737|147251623|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.43||0.42|TWO_SIDED|95.0|-1.19|0.5|||t-test, 2 sided|||||0.50|-1.19|0.42
73851882|NCT06899737|147251624|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.37||0.37|TWO_SIDED|95.0|-0.4|1.07|||t-test, 2 sided|||||1.07|-0.40|0.37
73851883|NCT06899737|147251626|SUPERIORITY||Mean Difference (Final Values)|6.72|STANDARD_ERROR_OF_MEAN|3.42||0.05|TWO_SIDED|95.0|-0.06|13.51|||t-test, 2 sided|||||13.51|-0.06|0.05
73851884|NCT06899737|147251627|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.35||0.23|TWO_SIDED|95.0|-0.26|1.11|||t-test, 2 sided|||||1.11|-0.26|0.23
73851885|NCT06899737|147251628|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.37||0.08|TWO_SIDED|95.0|-0.09|1.39|||t-test, 2 sided|||||1.39|-0.09|0.08
73851886|NCT06899737|147251629|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.38||0.11|TWO_SIDED|95.0|-0.15|1.35|||t-test, 2 sided|||||1.35|-0.15|0.11
73851887|NCT06899737|147251630|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.34||0.05|TWO_SIDED|95.0|-0.01|1.36|||t-test, 2 sided|||||1.36|-0.01|0.05
73961911|NCT00933400|147460488|EQUIVALENCE|equivalence margin = 0|Percent Difference|0.02|||||TWO_SIDED|95.0|-5.6|5.7||||||Difference in AMI rate. NULL: equal rates of AMI in both Groups.||5.7|-5.6|
73961912|NCT00933400|147460489|EQUIVALENCE|equivalence margin = 0|Difference (rates)|26.8|||||TWO_SIDED|95.0|21.4|32.2||||||Difference in Discharge rates. H0: equal rates of Discharge in both Groups.||32.2|21.4|
74024412|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.42|-0.06|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-0.42|0.008
73851888|NCT00375674|147251661|SUPERIORITY||Cox Proportional Hazard|0.761||||0.03|TWO_SIDED|95.0|0.594|0.975|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group.||Superiority analysis||0.975|0.594|0.030
73851889|NCT00375674|147251662|SUPERIORITY||Cox Proportional Hazard|0.811||||0.077|TWO_SIDED|95.0|0.643|1.023|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group||Superiority analysis||1.023|0.643|0.077
73851890|NCT00375674|147251663|SUPERIORITY||Hazard Ratio (HR)|0.929||||0.661|TWO_SIDED|95.0|0.67|1.289|||Log-rank test|||Hazard ratio was based on the Cox Proportional hazards model stratified by UISS High-Risk Group.||1.289|0.670|0.661
73851891|NCT03744910|147251673|OTHER||Treatment difference|-2.75|STANDARD_ERROR_OF_MEAN|1.563|||TWO_SIDED|95.0|-5.84|0.35||||||||0.35|-5.84|
73851892|NCT03430843|147251707|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0001|TWO_SIDED|95.0|0.57|0.85|||1-sided, Log Rank Test|||||0.85|0.57|0.0001
73851893|NCT02574078|147251741|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.505|TWO_SIDED|95.0|0.24|2.03|||Unstratified log-rank|||||2.03|0.24|0.5050
73851894|NCT02574078|147251741|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.6284|TWO_SIDED|95.0|0.22|2.54|||Unstratified log-rank|||||2.54|0.22|0.6284
73851895|NCT02574078|147251741|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1988|TWO_SIDED|95.0|0.4|1.22|||Unstratified log-rank|||||1.22|0.40|0.1988
73851896|NCT02574078|147251741|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.2722|TWO_SIDED|95.0|0.42|1.28|||Unstratified log-rank|||||1.28|0.42|0.2722
73851897|NCT02574078|147251741|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0544|TWO_SIDED|95.0|0.17|1.04|||Unstratified log-rank|||||1.04|0.17|0.0544
73851898|NCT02574078|147251741|SUPERIORITY||Hazard Ratio (HR)|2.04||||0.0442|TWO_SIDED|95.0|1.0|4.16|||Unstratified log-rank|||||4.16|1.00|0.0442
73851899|NCT02574078|147251741|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.5489|TWO_SIDED|95.0|0.5|1.45|||Log Rank|stratified by Disease Status (Recurrent Locally Advanced vs. Metastatic), Performance Status (ECOG 0 vs.1 vs. 2) as entered into the IVRS||||1.45|0.50|0.5489
73851900|NCT02574078|147251742|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9951|TWO_SIDED|95.0|0.35|2.91|||Unstratified log-rank|||||2.91|0.35|0.9951
73851901|NCT02574078|147251742|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.8321|TWO_SIDED|95.0|0.25|3.1|||Unstratified log-rank|||||3.10|0.25|0.8321
73851902|NCT02574078|147251742|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2938|TWO_SIDED|95.0|0.41|1.31|||Unstratified log-rank|||||1.31|0.41|0.2938
73851903|NCT02574078|147251742|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4819|TWO_SIDED|95.0|0.46|1.45|||Unstratified log-rank|||||1.45|0.46|0.4819
73851904|NCT02574078|147251742|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.0241|TWO_SIDED|95.0|0.11|0.91|||Unstratified log-rank|||||0.91|0.11|0.0241
73851905|NCT02574078|147251742|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.1401|TWO_SIDED|95.0|0.85|2.95|||Unstratified log-rank|||||2.95|0.85|0.1401
73851906|NCT02574078|147251746|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.2862|TWO_SIDED|95.0|0.4|1.31|||Log Rank|stratified by Disease Status (Recurrent Locally Advanced vs. Metastatic), Performance Status (ECOG 0 vs.1 vs. 2) as entered into the IVRS||||1.31|0.40|0.2862
73851907|NCT03037476|147251748|OTHER|General Linear Model|Slope|-0.235||||0.03|TWO_SIDED|95.0|-0.446|-0.023|||Mixed Models Analysis|Negative Binomial Regression||Changes from Baseline to 6 Month Follow-up Outcomes reported in this section.||-.023|-.446|0.03
73851908|NCT03037476|147251748|OTHER|General Linear Model|Slope|-0.149||||0.164|TWO_SIDED|95.0|-0.36|0.061|||Mixed Models Analysis|Negative Binomial Regression||Changes from Baseline to 12 Month Follow-up reported in this section.||.061|-.360|0.164
73851909|NCT03037476|147251749|OTHER|General Linear Model|Slope|-0.24||||0.603|TWO_SIDED|95.0|-1.12|0.65|||Mixed Models Analysis|Poisson Regression||Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 6 Month Followup||.650|-1.120|.603
73851910|NCT03037476|147251749|OTHER|General Linear Model|Slope|-0.336||||0.465|TWO_SIDED|95.0|-1.238|0.566|||Mixed Models Analysis|Poisson Regression||Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 12 Month Followup||.566|-1.238|.465
73851911|NCT03037476|147251750|OTHER|General Linear Model|Slope|-0.059||||0.486|TWO_SIDED|95.0|-0.227|0.108|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 12 Month Tobacco Use from Baseline to 6 Month Followup||.108|-.227|.486
73851912|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.006||||0.942|TWO_SIDED|95.0|-0.16|0.172|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 12 Month Tobacco Use from Baseline to 12 Month Followup||.172|-.160|.942
73851913|NCT03037476|147251750|OTHER|General Linear Model|Slope|-0.042||||0.552|TWO_SIDED|95.0|-0.18|0.097|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Alcohol Use from Baseline to 6 Month Followup||.097|-.180|.552
73851914|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.037||||0.608|TWO_SIDED|95.0|-0.104|0.177|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Alcohol Use from Baseline to 12 Month Followup||.177|-.104|.608
73851915|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.015||||0.84|TWO_SIDED|95.0|-0.13|0.16|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Other Drug Use from Baseline to 6 Month Followup||.160|-.130|.840
73851916|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.007||||0.927|TWO_SIDED|95.0|-0.142|0.155|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Other Drug Use from Baseline to 12 Month Followup||.155|-.142|.927
73851917|NCT03037476|147251750|OTHER|General Linear Model|Slope|-0.01||||0.932|TWO_SIDED|95.0|-0.244|0.223|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup||.223|-.244|.932
73961913|NCT00933400|147460489|EQUIVALENCE|equivalence margin = 0|Difference (percents)|5.6|||||TWO_SIDED|95.0|0.0|11.2|||||exact procedures were used to estimate and compare rates of detection for significant coronary disease|Difference in diagnosis rate of Significant coronary disease at index visit. H0: equal rates in both Groups.||11.2|0.0|
73961914|NCT00933400|147460491|SUPERIORITY||binomial proportion|26.8|||||TWO_SIDED|95.0|21.4|32.2|||||Exact confidence intervals for the difference in proportions|H0: no difference in Patient disposition (Discharge) rates between arms||32.2|21.4|
73851918|NCT03037476|147251750|OTHER|General Linear Model|Slope|-0.057||||0.648|TWO_SIDED|95.0|-0.3|0.187|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup||0.187|-.300|.648
73851919|NCT03037476|147251750|OTHER|General Linear Model|Slope|-0.059||||0.702|TWO_SIDED|95.0|-0.363|0.245|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Tobacco Use from Baseline to 6 Month Followup||.245|-.363|.702
73851920|NCT03037476|147251750|OTHER|General Linear Model|Slope|-0.1||||0.524|TWO_SIDED|95.0|-0.408|0.208|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Tobacco Use from Baseline to 12 Month Followup||.208|-.408|.524
73851921|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.008||||0.913|TWO_SIDED|95.0|-0.137|0.153|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Alcohol Use from Baseline to 6 Month Followup||.153|-.137|.913
73851922|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.032||||0.676|TWO_SIDED|95.0|-0.117|0.181|||Mixed Models Analysis|Poisson Regresision||Change in Past 3 Month Alcohol Use from Baseline to 12 Month Followup||.181|-.117|.676
73851923|NCT03037476|147251750|OTHER|General Linear Model|Slope|-0.035||||0.712|TWO_SIDED|95.0|-0.223|0.152|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Marijuana Use from Baseline to 6 Month Followup||.152|-.223|.712
73851924|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.005||||0.956|TWO_SIDED|95.0|-0.186|0.197|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Marijuana Use from Baseline to 12 Month Followup||0.197|-.186|.956
73851925|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.149||||0.446|TWO_SIDED|95.0|-0.234|0.531|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Stimulant Use from Baseline to 6 Month Followup||.531|-.234|.446
73851926|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.055||||0.793|TWO_SIDED|95.0|-0.353|0.462|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Stimulant Use from Baseline to 12 Month Followup||.462|-.353|.793
73851927|NCT03037476|147251750|OTHER|General Linear Model|Slope|-0.001||||0.999|TWO_SIDED|95.0|-2.005|2.003|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Heroin Use from Baseline to 6 Month Followup||2.003|-2.005|.999
73851928|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.999||||0.397|TWO_SIDED|95.0|-1.312|3.31|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Heroin Use from Baseline to 12 Month Followup||3.310|-1.312|.397
73851929|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.465||||0.303|TWO_SIDED|95.0|-0.419|1.349|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup||1.349|-.419|.303
73851930|NCT03037476|147251750|OTHER|General Linear Model|Slope|0.939|||<|0.05|TWO_SIDED|95.0|0.128|1.751|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup||1.751|.128|<.05
73851931|NCT03037476|147251751|OTHER|General Linear Model|Slope|-0.1816||||0.151|TWO_SIDED|95.0|-0.4295|0.0663|||Mixed Models Analysis|Negative binomial regression||Change in ASSIST Score over time: 6 month follow up||0.0663|-0.4295|0.151
73851932|NCT03037476|147251751|OTHER|General Linear Model|Slope|-0.0601||||0.642|TWO_SIDED|95.0|-0.3133|0.1931|||Mixed Models Analysis|Negative Binomial Regression||Changes in ASSIST scores at 12 month follow up||0.1931|-0.3133|0.642
73851933|NCT03037476|147251752|OTHER|General Linear Model|Slope|-0.2177||||0.074|TWO_SIDED|95.0|-0.4566|0.0213|||Mixed Models Analysis|Negative Binomial Regression||Change in consequence score at 6 month follow up||0.0213|-0.4566|0.074
73851934|NCT03037476|147251752|OTHER|General Linear Model|Slope|-0.1165||||0.351|TWO_SIDED|95.0|-0.3612|0.1282|||Mixed Models Analysis|Negative Binomial Regression||Change in consequence score at 12 month follow up||0.1282|-0.3612|0.351
73851935|NCT03037476|147251753|OTHER|General Linear Model|Slope|0.044||||0.255|TWO_SIDED|95.0|-0.032|0.1197|||Mixed Models Analysis|Negative Binomial Regression||Change in peak alcohol quantity at 6 months (reported by number of standard drinks)||0.1197|-0.032|0.255
73851936|NCT03037476|147251753|OTHER|General Linear Model|Slope|0.0315||||0.428|TWO_SIDED|95.0|-0.0463|0.1092|||Mixed Models Analysis|Negative Binomial Regression||Change in peak alcohol quantity (reported in standard drinks) at 12 month follow-up||0.1092|-0.0463|0.428
73851937|NCT03037476|147251754|OTHER|General Linear Model|Slope|0.0021||||0.966|TWO_SIDED|95.0|-0.0936|0.0978|||Mixed Models Analysis|Negative Binomial Regression||Change in DDQ score at 6 months||0.0978|-0.0936|0.966
73851938|NCT03037476|147251754|OTHER|General Linear Model|Slope|-0.0559||||0.265|TWO_SIDED|95.0|-0.1542|0.0424|||Mixed Models Analysis|Negative Binomial Regression||Change in DDQ score at 12 month follow-up||0.0424|-0.1542|0.265
73851939|NCT03037476|147251755|OTHER|General Linear Model|Slope|-0.0128||||0.868|TWO_SIDED|95.0|-0.1633|0.1378|||Mixed Models Analysis|Negative Binomial Regression||Change in RAPI count at 6 month follow-up||0.1378|-0.1633|0.868
73851940|NCT03037476|147251755|OTHER|General Linear Model|Slope|-0.0445||||0.573|TWO_SIDED|95.0|-0.1993|0.1102|||Mixed Models Analysis|Negative Binomial Regression||Change in RAPI count at 12 month follow-up||0.1102|-0.1993|0.573
73851941|NCT03037476|147251756|OTHER|General Linear Model|Slope|-0.0899||||0.266|TWO_SIDED|95.0|-0.2484|0.0685|||Mixed Models Analysis|Negative Binomial Regression||Change in past 12 month marijuana use at 6 month follow-up||0.0685|-0.2484|0.266
73851942|NCT03037476|147251756|OTHER|General Linear Model|Slope|-0.0197||||0.816|TWO_SIDED|95.0|-0.1859|0.1465|||Mixed Models Analysis|Negative Binomial Regression||Past 12 month marijuana use at 12 month follow-up||0.1465|-0.1859|0.816
73851943|NCT03037476|147251756|OTHER|General Linear Model|Slope|-0.1031||||0.209|TWO_SIDED|95.0|-0.2639|0.0577|||Mixed Models Analysis|Negative Binomial Regression||Change in past 6 month marijuana use at 6 month follow-up||0.0577|-0.2639|0.209
73851944|NCT03037476|147251756|OTHER|General Linear Model|Slope|-0.006||||0.944|TWO_SIDED|95.0|-0.1729|0.1608|||Mixed Models Analysis|Negative Binomial Regression||Change in past 6 month marijuana use at 12 month follow-up||0.1608|-0.1729|0.944
73851945|NCT03037476|147251756|OTHER|General Linear Model|Slope|-0.0391||||0.654|TWO_SIDED|95.0|-0.2102|0.132|||Mixed Models Analysis|Negative Binomial Regression||Change in past month marijuana use at 6 month follow-up||0.1320|-0.2102|0.654
74024413|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.63|-0.26|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.26|-0.63|<0.001
73961915|NCT00933400|147460493|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|-0.4|||||TWO_SIDED|95.0|-6.0|5.2|||||Exact confidence intervals for the difference in proportions|Compare all cause mortality between groups||5.2|-6.0|
73961916|NCT00933400|147460493|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|0.1|||||TWO_SIDED|95.0|-5.5|5.7|||||Exact confidence intervals for the difference in proportions|Compare Cardiac Death between groups||5.7|-5.5|
73961917|NCT00933400|147460493|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|0.1|||||TWO_SIDED|95.0|-5.6|5.9|||||Exact confidence intervals for the difference in proportions|Compare AMI between groups||5.9|-5.6|
73961918|NCT00933400|147460493|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|3.0|||||TWO_SIDED|95.0|-5.5|6.0|||||Exact confidence intervals for the difference in proportions|Compare MACE between groups||6.0|-5.5|
73961919|NCT00933400|147460493|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|1.3|||||TWO_SIDED|95.0|-4.4|7.0|||||Exact confidence intervals for the difference in proportions|Compare Revascularization between groups||7.0|-4.4|
73961920|NCT02299375|147460526|SUPERIORITY_OR_OTHER||Adjusted median|1.04|STANDARD_DEVIATION|0.28|||TWO_SIDED|95.0|0.63|1.73|||||Data presented above are for 95% equal-tailed credible intervals. The estimated posterior probability that the true ratio losmapimod/placebo is \<1 assuming noninformative priors is 0.44.The estimated posterior probability that the true ratio losmapi|||1.73|0.63|
73961921|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.371|TWO_SIDED|95.0|-0.031|0.084||Analysis performed using a Mixed-effect Model Repeated Measures (MMRM) with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 2|||0.084|-0.031|0.371
73961922|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035||||0.244|TWO_SIDED|95.0|-0.024|0.093||Analysis performed using a Mixed-effect Repeated Measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 4|||0.093|-0.024|0.244
73961923|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.05|TWO_SIDED|95.0|0.0|0.119||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 8|||0.119|-0.000|0.050
73961924|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002||||0.942|TWO_SIDED|95.0|-0.063|0.058||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 12|||0.058|-0.063|0.942
73961925|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.127|TWO_SIDED|95.0|-0.014|0.114||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 18|||0.114|-0.014|0.127
73961926|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.079||||0.024|TWO_SIDED|95.0|0.011|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 26|||0.148|0.011|0.024
74024414|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.64|-0.28|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-0.64|<0.001
74024415|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.76|-0.39|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.76|<0.001
74024416|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.53|-0.16|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.16|-0.53|<0.001
73851946|NCT03037476|147251756|OTHER|General Linear Model|Slope|-0.0646||||0.481|TWO_SIDED|95.0|-0.2444|0.1152|||Mixed Models Analysis|Negative Binomial Regression||Change in past month marijuana use at 12 month follow-up||0.1152|-0.2444|0.481
73961927|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086||||0.057|TWO_SIDED|95.0|-0.003|0.174||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 39|||0.174|-0.003|0.057
73961928|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.481|TWO_SIDED|95.0|-0.09|0.191||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 52|||0.191|-0.090|0.481
73961929|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.014||||0.521|TWO_SIDED|95.0|-0.03|0.059||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 2|||0.059|-0.030|0.521
73961930|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.084|TWO_SIDED|95.0|-0.005|0.086||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 4|||0.086|-0.005|0.084
74024417|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.54|-0.17|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.54|<0.001
74024418|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.85|-0.49|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.49|-0.85|<0.001
74024419|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.63|-0.25|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.25|-0.63|<0.001
73851947|NCT03037476|147251757|OTHER|General Linear Model|Slope|-0.0411||||0.487|TWO_SIDED|95.0|-0.1569|0.0747|||Mixed Models Analysis|Negative Binomial Regression||Change in RMPI count at 6 month follow-up||0.0747|-0.1569|0.487
73851948|NCT03037476|147251757|OTHER|General Linear Model|Slope|0.0177||||0.772|TWO_SIDED|95.0|-0.1021|0.1375|||Mixed Models Analysis|Negative Binomial Regression||Change in RMPI count at 12 month follow-up||0.1375|-0.1021|0.772
73851949|NCT03037476|147251758|OTHER|General Linear Model|Slope|0.1285||||0.075|TWO_SIDED|95.0|-0.0131|0.2702|||Mixed Models Analysis|Negative Binomial Regression||Change in PBS count at 6 month follow up||0.2702|-0.0131|0.075
73851950|NCT03037476|147251758|OTHER|General Linear Model|Slope|0.0936||||0.207|TWO_SIDED|95.0|-0.0517|0.2388|||Mixed Models Analysis|Negative Binomial Regression||Change in PBS count at 12 month follow up||0.2388|-0.0517|0.207
73851951|NCT03037476|147251759|OTHER|General Linear Model|Slope|-0.1604|||<|0.001|TWO_SIDED|95.0|-0.2525|-0.0683|||Mixed Models Analysis|Negative Binomial Regression||Change in perceived norm (in perceived days of use in past year) at 6 month follow up||-0.0683|-0.2525|<0.001
73851952|NCT03037476|147251759|OTHER|General Linear Model|Slope|-0.1441|||<|0.003|TWO_SIDED|95.0|-0.2404|-0.0478|||Mixed Models Analysis|Negative Binomial Regression||Change in perceived norm (perceived number of days of use in past year) at 12 month follow up||-0.0478|-0.2404|<.003
73851953|NCT03037476|147251760|OTHER|General Linear Model|Slope|-0.0157||||0.743|TWO_SIDED|95.0|-0.1096|0.0782|||Mixed Models Analysis|Poisson regression||Change in MSLQ score at 6 month follow-up||0.0782|-0.1096|0.743
73851954|NCT03037476|147251760|OTHER|General Linear Model|Slope|0.0133||||0.784|TWO_SIDED|95.0|-0.0816|0.1081|||Mixed Models Analysis|Poisson regression||Change in MSLQ score at 12 month follow up||0.1081|-0.0816|0.784
73851955|NCT03037476|147251761|OTHER|General Linear Model|Slope|-0.0061||||0.914|TWO_SIDED|95.0|-0.1161|0.104|||Mixed Models Analysis|Poisson regression||Change in cumulative grade point average at 6 month follow up||0.104|-0.1161|0.914
73851956|NCT03037476|147251761|OTHER|General Linear Model|Slope|-0.0092||||0.871|TWO_SIDED|95.0|-0.1202|0.1018|||Mixed Models Analysis|General Linear Model||Change in cumulative grade point average at 12 month follow up||0.1018|-0.1202|0.871
73851957|NCT03037476|147251761|OTHER|General Linear Model|Slope|0.003||||0.957|TWO_SIDED|95.0|-0.1063|0.1124|||Mixed Models Analysis|Poisson regression||Change in last term GPA at 6 month follow-up||0.1124|-0.1063|0.957
73851958|NCT03037476|147251761|OTHER|General Linear Model|Slope|0.0006||||0.992|TWO_SIDED|95.0|-0.1098|0.1109|||Mixed Models Analysis|Poisson regression||Change in last term GPA at 12 month follow-up||0.1109|-0.1098|0.992
73851959|NCT03037476|147251762|OTHER|General Linear Model|Slope|0.039||||0.447|TWO_SIDED|95.0|-0.0615|0.1395|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol frequency at 6 month follow-up||0.1395|-.0615|0.447
73851960|NCT03037476|147251762|OTHER|General Linear Model|Slope|0.0398||||0.443|TWO_SIDED|95.0|-0.0619|0.1414|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol frequency at 12 month follow-up||0.1414|-0.0619|0.443
73851961|NCT03037476|147251763|OTHER|General Linear Model|Slope|0.0002||||0.997|TWO_SIDED|95.0|-0.1066|0.107|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol typical quantity at 6 months||0.1070|-0.1066|0.997
73851962|NCT03037476|147251763|OTHER|General Linear Model|Slope|-0.0136||||0.808|TWO_SIDED|95.0|-0.1236|0.0963|||Mixed Models Analysis|Negative Binomial Regression||Change in past month typical alcohol quantity at 12 month follow-up||0.0963|-0.1236|0.808
73851963|NCT00501592|147251767|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 25 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.||||0.040
73851964|NCT00501592|147251767|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 50 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.||||0.28
73851965|NCT00501592|147251768|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||t-test, 2 sided|||||||0.0031
73851966|NCT00501592|147251768|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
73851967|NCT00501592|147251768|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||||||0.0001
73851968|NCT00501592|147251768|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||t-test, 2 sided|||||||0.0005
73851969|NCT01525862|147251771|SUPERIORITY||||||<|0.0001||||||P values \<0.05 are considered statistically significant.|t-test, 2 sided|||||||<0.0001
73851970|NCT01498692|147251775|SUPERIORITY_OR_OTHER||Percent Target Lesion Failure|2.4|||<|0.0001|ONE_SIDED|95.0||7.3|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 21.1%.||7.3||<0.0001
73851971|NCT00135330|147251823|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||ANCOVA|||The ratio of the ASI-iAUC at Week 20 to that at baseline was compared between the treatment groups.||||0.282
73851972|NCT00135330|147251824|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|||||||0.004
73902199|NCT03036800|147334414|SUPERIORITY||Odds Ratio (OR)|6.53|||<|0.001|TWO_SIDED|95.0|3.32|12.86|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.86|3.32|<0.001
73902200|NCT03036800|147334415|SUPERIORITY||Odds Ratio (OR)|8.08|||<|0.001|TWO_SIDED|95.0|3.8|17.16|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||17.16|3.80|<0.001
73902201|NCT03036800|147334416|SUPERIORITY||Odds Ratio (OR)|2.28||||0.065|TWO_SIDED|95.0|0.95|5.47|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||5.47|0.95|0.065
73902202|NCT03036800|147334417|SUPERIORITY||Odds Ratio (OR)|2.84||||0.206|TWO_SIDED|95.0|0.56|14.34|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.34|0.56|0.206
73902203|NCT03036800|147334418|SUPERIORITY||Odds Ratio (OR)|3.23||||0.023|TWO_SIDED|95.0|1.17|8.9|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥32% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||8.90|1.17|0.023
73902204|NCT03036800|147334419|SUPERIORITY||Odds Ratio (OR)|4.11||||0.07|TWO_SIDED|95.0|0.89|18.93|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||18.93|0.89|0.070
73902205|NCT03036800|147334420|SUPERIORITY||Odds Ratio (OR)|0.59||||0.601|TWO_SIDED|95.0|0.08|4.24|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.24|0.08|0.601
73902206|NCT03036800|147334421|SUPERIORITY||Mean Difference (Net)|-4.63|||<|0.001|TWO_SIDED|95.0|-5.85|-3.4|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.4|-5.85|<0.001
73902207|NCT03036800|147334422|SUPERIORITY||Mean Difference (Net)|-5.89|||<|0.001|TWO_SIDED|95.0|-7.76|-4.02|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.02|-7.76|<0.001
73902208|NCT03036800|147334423|SUPERIORITY||Mean Difference (Net)|-6.87|||<|0.001|TWO_SIDED|95.0|-9.03|-4.71|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.71|-9.03|<0.001
73961931|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033||||0.266|TWO_SIDED|95.0|-0.025|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 8|||0.090|-0.025|0.266
73961932|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012||||0.665|TWO_SIDED|95.0|-0.066|0.042||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 12|||0.042|-0.066|0.665
74024420|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.19|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-0.57|<0.001
73902209|NCT03036800|147334424|SUPERIORITY||Mean Difference (Net)|-5.44|||<|0.001|TWO_SIDED|95.0|-8.34|-2.53|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.53|-8.34|<0.001
73902210|NCT03036800|147334425|SUPERIORITY||Mean Difference (Net)|-3.72|||<|0.001|TWO_SIDED|95.0|-4.63|-2.8|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.80|-4.63|<0.001
73902211|NCT03036800|147334426|SUPERIORITY||Mean Difference (Net)|-4.7|||<|0.001|TWO_SIDED|95.0|-6.14|-3.25|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.25|-6.14|<0.001
73902212|NCT03036800|147334427|SUPERIORITY||Mean Difference (Net)|-5.37|||<|0.001|TWO_SIDED|95.0|-7.02|-3.71|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.71|-7.02|<0.001
73961933|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.023||||0.489|TWO_SIDED|95.0|-0.043|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 18|||0.090|-0.043|0.489
73902213|NCT03036800|147334428|SUPERIORITY||Mean Difference (Net)|-4.1||||0.001|TWO_SIDED|95.0|-6.42|-1.77|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.77|-6.42|0.001
73961934|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.099||||0.007|TWO_SIDED|95.0|0.028|0.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 26|||0.170|0.028|0.007
73961935|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.248|TWO_SIDED|95.0|-0.039|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 39|||0.148|-0.039|0.248
73851973|NCT00135330|147251825|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||ANCOVA|||||||0.308
73851974|NCT00135330|147251826|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||ANCOVA|||||||0.079
73851975|NCT00135330|147251827|SUPERIORITY_OR_OTHER|||||||0.252||95.0|||||ANCOVA|||||||0.252
73851976|NCT00135330|147251828|SUPERIORITY_OR_OTHER|||||||0.465||95.0|||||ANCOVA|||||||0.465
73851977|NCT00135330|147251829|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||ANCOVA|||||||0.348
73851978|NCT00135330|147251833|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Mixed Model Repeated Measures (MMRM)|||||||0.039
73851979|NCT00135330|147251834|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||MMRM|||||||0.555
73851980|NCT00135330|147251836|SUPERIORITY_OR_OTHER|||||||0.106||95.0|||||MMRM|||||||0.106
73851981|NCT00135330|147251837|SUPERIORITY_OR_OTHER|||||||0.341||95.0|||||MMRM|||||||0.341
73851982|NCT00135330|147251838|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||MMRM|||||||<0.001
73851983|NCT00135330|147251839|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||MMRM|||||||0.276
73851984|NCT00135330|147251840|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||MMRM|||||||0.840
73851985|NCT00135330|147251841|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||MMRM|||||||0.096
73851986|NCT00135330|147251842|SUPERIORITY_OR_OTHER|||||||0.875||95.0|||||MMRM|||||||0.875
73851987|NCT00135330|147251843|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||ANCOVA|||||||0.581
73851988|NCT00135330|147251844|SUPERIORITY_OR_OTHER|||||||0.631||95.0|||||ANCOVA|||||||0.631
73851989|NCT00135330|147251845|SUPERIORITY_OR_OTHER|||||||0.724||95.0|||||ANCOVA|||||||0.724
73851990|NCT00135330|147251846|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||MMRM|||||||0.117
73851991|NCT00135330|147251847|SUPERIORITY_OR_OTHER|||||||0.251||95.0|||||MMRM|||||||0.251
73851992|NCT00135330|147251848|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||MMRM|||||||0.710
73851993|NCT00135330|147251849|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Fisher Exact|||||||0.575
73851994|NCT00135330|147251850|SUPERIORITY_OR_OTHER|||||||0.436||95.0|||||ANOVA|||||||0.436
73851995|NCT00135330|147251851|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Generalized Linear Model|||||||0.168
73851996|NCT00066222|147251855|OTHER|||||||||||||||||This study was designed to detect an improvement in the 2-year overall survival rate from 47% to 60%. Using a one-group chi-square test with a one-sided significance level of 0.10, a sample of 67 patients was deemed sufficient to detect the difference between the null hypothesis (H0: P .47) and the alternative hypothesis (HA: P .60) with 80% power.|If the point estimate for two-year survival is less than or equal to 0.54815, the upper bound of the one-sided 90% confidence interval on 47%, then H0 would not be rejected and the conclusion would be that the two-year survival rate did not statistically improve from 47% under the new treatment. If the point estimate is greater than 0.54815, then H0 would be rejected and the conclusion is that the two-year survival rate did improve from 47% to 60% under the new treatment.|||
73851997|NCT00066222|147251858|OTHER||||||||||||||||||The following rule would reject the null hypothesis that the proportion of severe esophagitis was 30% with an overall significance level of 0.05: 27 or more cases of severe esophagitis among the total sample of evaluable patients.|||
73851998|NCT00066222|147251859|OTHER||||||||||||||||||The following rule would reject the null hypothesis that the proportion of treatment-related fatalities was less than or equal to 5% with an overall significance level of 0.05: 6 or more instances of treatment-related fatalities among the total sample of evaluable patients.|||
73851999|NCT02767869|147251861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
73852000|NCT02767869|147251862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.530
73852001|NCT02767869|147251863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||||||0.034
73852002|NCT02767869|147251864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
73852003|NCT02767869|147251865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||||||0.799
73852004|NCT02767869|147251866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
73852005|NCT02767869|147251867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
73852006|NCT02767869|147251868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.919|||||||Wilcoxon (Mann-Whitney)|||||||0.919
73852007|NCT02767869|147251869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.254|||||||Wilcoxon (Mann-Whitney)|||||||0.254
73852008|NCT02767869|147251870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.347|||||||Wilcoxon (Mann-Whitney)|||||||0.347
73852009|NCT02767869|147251871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
73852010|NCT02767869|147251872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.410
73852011|NCT02767869|147251873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
73852012|NCT03517371|147251942|SUPERIORITY||Mean Difference (Final Values)|72.35||||0.89|TWO_SIDED|95.0|-943.34|1088.04|||t-test, 2 sided|||||1088.04|-943.34|.89
73852013|NCT03517371|147251943|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.42|TWO_SIDED|95.0|-3.8|3.1|||t-test, 2 sided|||||3.10|-3.80|.42
73852014|NCT03517371|147251944|SUPERIORITY||Median Difference (Final Values)|2.17||||0.85|TWO_SIDED|95.0|-20.64|24.97|||t-test, 2 sided|Levene's test significant, equal variances not assumed values reported.||||24.97|-20.64|.85
73852015|NCT03517371|147251945|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.824|TWO_SIDED|95.0|-0.081|0.065|||t-test, 2 sided|||||.065|-.081|.824
73852016|NCT04283656|147251955|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.76|1.24||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.24|0.76|
73852017|NCT04283656|147251956|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.66|1.32||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.32|0.66|
73852018|NCT04283656|147251957|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.76|1.24||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine C24 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.24|0.76|
73852019|NCT04283656|147251958|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.17|||||TWO_SIDED|90.0|0.91|1.5||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.50|0.91|
73852020|NCT04283656|147251959|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.38|||||TWO_SIDED|90.0|0.73|2.6||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||2.60|0.73|
73852021|NCT04283656|147251960|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.14|||||TWO_SIDED|90.0|0.93|1.4||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir C24 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.40|0.93|
74024421|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.8|-0.42|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.42|-0.80|<0.001
74024422|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.035|TWO_SIDED|95.0|-0.42|-0.02|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-0.42|0.035
74024423|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.125|TWO_SIDED|95.0|-0.36|0.04|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.04|-0.36|0.125
73902214|NCT03036800|147334429|SUPERIORITY||Mean Difference (Net)|-2.7|||<|0.001|TWO_SIDED|95.0|-3.5|-1.91|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.91|-3.5|<0.001
73902215|NCT03036800|147334430|SUPERIORITY||Mean Difference (Net)|-1.89|||<|0.001|TWO_SIDED|95.0|-2.91|-0.86|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-0.86|-2.91|<0.001
73902216|NCT03036800|147334431|SUPERIORITY||Mean Difference (Net)|-3.28||||0.01|TWO_SIDED|95.0|-5.77|-0.8|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-0.80|-5.77|0.01
73902217|NCT03036800|147334432|SUPERIORITY||Mean Difference (Net)|-5.51||||0.003|TWO_SIDED|95.0|-9.09|-1.94|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.94|-9.09|0.003
73902218|NCT03036800|147334452|SUPERIORITY||Odds Ratio (OR)|10.53|||<|0.001|TWO_SIDED|95.0|3.83|28.97|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||28.97|3.83|<0.001
73902219|NCT03036800|147334453|SUPERIORITY||Odds Ratio (OR)|23.1|||<|0.001|TWO_SIDED|95.0|7.55|70.67|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||70.67|7.55|<0.001
73902220|NCT03036800|147334456|SUPERIORITY||Odds Ratio (OR)|7.71|||<|0.001|TWO_SIDED|95.0|2.75|21.6|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||21.60|2.75|<0.001
73902221|NCT03036800|147334457|SUPERIORITY||Odds Ratio (OR)|6.14||||0.032|TWO_SIDED|95.0|1.16|32.32|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||32.32|1.16|0.032
73902222|NCT03036800|147334458|SUPERIORITY||Odds Ratio (OR)|11.48|||<|0.001|TWO_SIDED|95.0|3.8|34.67|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||34.67|3.80|<0.001
73902223|NCT03036800|147334460|SUPERIORITY||Odds Ratio (OR)|13.63||||0.003|TWO_SIDED|95.0|2.47|75.09|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||75.09|2.47|0.003
73902224|NCT03036800|147334461|SUPERIORITY||Odds Ratio (OR)|0.59||||0.601|TWO_SIDED|95.0|0.08|4.24|||Regression, Logistic|||A logistic regression with a binary outcome of maintenance of weight loss of ≥15% at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.24|0.08|0.601
73902225|NCT03036800|147334462|SUPERIORITY||Mean Difference (Net)|-6.55|||<|0.001|TWO_SIDED|95.0|-7.81|-5.29|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.29|-7.81|<0.001
73902226|NCT03036800|147334463|SUPERIORITY||Mean Difference (Net)|-9.59|||<|0.001|TWO_SIDED|95.0|-11.3|-7.88|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-7.88|-11.30|<0.001
73902227|NCT03036800|147334464|SUPERIORITY||Mean Difference (Net)|-13.51|||<|0.001|TWO_SIDED|95.0|-15.51|-11.51|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-11.51|-15.51|<0.001
73902228|NCT03036800|147334465|SUPERIORITY||Mean Difference (Net)|-9.3|||<|0.001|TWO_SIDED|95.0|-12.35|-6.26|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-6.26|-12.35|<0.001
73902229|NCT03036800|147334466|SUPERIORITY||Mean Difference (Net)|-6.16|||<|0.001|TWO_SIDED|95.0|-7.03|-5.28|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.28|-7.03|<0.001
73902230|NCT03036800|147334467|SUPERIORITY||Mean Difference (Net)|-4.22|||<|0.001|TWO_SIDED|95.0|-5.56|-2.89|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.89|-5.56|<0.001
73902231|NCT03036800|147334468|SUPERIORITY||Median Difference (Net)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.96|-5.64|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.64|-11.96|<0.001
73902232|NCT03036800|147334469|SUPERIORITY||Median Difference (Net)|-9.59||||0.001|TWO_SIDED|95.0|-14.91|-4.27|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.27|-14.91|0.001
73902233|NCT01077154|147334470|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7|TWO_SIDED|95.0|0.82|1.14|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.14|0.82|0.70
73902234|NCT01077154|147334471|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.57|TWO_SIDED|95.0|0.91|1.19|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hzard ratio \< 1 favors denosumab.|||1.19|0.91|0.57
73902235|NCT01077154|147334472|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.26|TWO_SIDED|95.0|0.92|1.36|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.36|0.92|0.26
73902236|NCT01077154|147334473|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.83|1.22|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.22|0.83|0.94
73902237|NCT01077154|147334474|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.41|TWO_SIDED|95.0|0.92|1.21|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.21|0.92|0.41
73902238|NCT03505671|147334520|OTHER|||||||0.61|||||||ANCOVA|||||||0.61
73902239|NCT03505671|147334520|OTHER||Correlation Coefficient|0.15|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (overall, N=20)|||||
73902240|NCT03505671|147334520|OTHER||Correlation coefficient|0.25|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (intervention, N=9)|||||
73902241|NCT03505671|147334520|OTHER||Correlation coefficient|0.09|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (Usual Care, N=11)|||||
73902242|NCT03505671|147334521|OTHER|||||||0.91||||||P value for the motor subscale|ANCOVA|||||||0.91
74024424|NCT00733902|147600906|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.58|-0.18|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.18|-0.58|<0.001
73902243|NCT03505671|147334521|OTHER|||||||0.55||||||P value for autonomic subscale|ANCOVA|||||||0.55
73902244|NCT03505671|147334522|OTHER|||||||0.41||||||P value for baseline numbness or tingling severity data|Fisher Exact|||||||0.41
73902245|NCT03505671|147334522|OTHER|||||||0.22||||||P value for baseline numbness or tingling interference data|Fisher Exact|||||||0.22
73902246|NCT03505671|147334522|OTHER|||||||0.58||||||Week 12 p value for numbness or tingling severity data|Fisher Exact|||||||0.58
73902247|NCT03505671|147334522|OTHER|||||||0.12||||||P value for Week 12 numbness or tingling interference data|Fisher Exact|||||||0.12
73902248|NCT03505671|147334522|OTHER|||||||0.57||||||Week 12 - Baseline p value for numbness or tingling severity data|Fisher Exact|||||||0.57
73902249|NCT03505671|147334522|OTHER|||||||0.55||||||Week 12 - Baseline p value for numbness or tingling interference|Fisher Exact|||||||0.55
73902250|NCT03505671|147334523|OTHER|||||||0.99||||||P value for baseline numbness or tingling severity Grade 1-3|Fisher Exact|||||||0.99
73902251|NCT03505671|147334523|OTHER|||||||0.99||||||P value for 12 weeks numbness or tingling severity Grade 1-3|Fisher Exact|||||||0.99
73902252|NCT03505671|147334523|OTHER|||||||0.99||||||P value for week 12 - baseline change in numbness or tingling severity|Fisher Exact|||||||0.99
73902253|NCT03505671|147334524|OTHER|||||||0.99|||||||Fisher Exact|||||||0.99
73902254|NCT03505671|147334525|OTHER|||||||0.69|||||||t-test, 2 sided|||||||0.69
73902255|NCT03505671|147334526|OTHER|||||||0.46||||||P value for cross sectional area sural data|ANCOVA|||||||0.46
73902256|NCT03505671|147334526|OTHER|||||||0.22||||||P value for cross sectional area for median data|ANCOVA|||||||0.22
73902257|NCT03505671|147334527|OTHER|||||||0.2||||||P value for amplitude - sural data|ANCOVA|||||||0.20
73902258|NCT03505671|147334527|OTHER|||||||0.28||||||P value for amplitude - tibial, ankle|ANCOVA|||||||0.28
73902259|NCT03505671|147334527|OTHER|||||||0.13||||||P value for amplitude tibial, pop fossa|ANCOVA|||||||0.13
73902260|NCT03505671|147334527|OTHER|||||||0.71||||||P value for amplitude median, wrist|ANCOVA|||||||0.71
73902261|NCT03505671|147334527|OTHER|||||||0.46||||||P value for amplitude, median, elbow|ANCOVA|||||||0.46
73902262|NCT03505671|147334528|OTHER|||||||0.81||||||P value for latency sural data|ANCOVA|||||||0.81
73902263|NCT03505671|147334528|OTHER|||||||0.76||||||P value for latency tibial, ankle data|ANCOVA|||||||0.76
73902264|NCT03505671|147334528|OTHER|||||||0.24||||||P value for latency tibial, pop fossa|ANCOVA|||||||0.24
73902265|NCT03505671|147334528|OTHER|||||||0.2||||||P value for latency median wrist data|ANCOVA|||||||0.20
73902266|NCT03505671|147334528|OTHER|||||||0.51||||||P value for latency median elbow data|ANCOVA|||||||0.51
73902267|NCT03505671|147334529|OTHER|||||||0.98||||||P value for velocity sural data|ANCOVA|||||||0.98
74024425|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-0.49|<0.001
73902268|NCT03505671|147334529|OTHER|||||||0.03||||||P value for velocity tibial data|ANCOVA|||||||0.03
73902269|NCT03505671|147334529|OTHER|||||||0.81||||||P value for velocity median data|ANCOVA|||||||0.81
73902270|NCT02038829|147334534|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0126|STANDARD_ERROR_OF_MEAN|0.0225||0.973|TWO_SIDED|95.0|-0.0318|0.0569||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.0569|-0.0318|0.9730
73902271|NCT02038829|147334534|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0822|STANDARD_ERROR_OF_MEAN|0.0225||0.0014|TWO_SIDED|95.0|0.038|0.1264||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1264|0.0380|0.0014
73902272|NCT02038829|147334534|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1088|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.0644|0.1532||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1532|0.0644|<0.0001
73902273|NCT02038829|147334534|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1375|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.0931|0.1818||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation||0.1818|0.0931|<0.0001
73902274|NCT02038829|147334534|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1567|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.1121|0.2012||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2012|0.1121|<0.0001
73902275|NCT02038829|147334535|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0526|STANDARD_ERROR_OF_MEAN|0.0184||0.0046|TWO_SIDED|95.0|0.0163|0.0888|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.0888|0.0163|0.0046
73930716|NCT03238911|147391297|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.858|TWO_SIDED|95.0|-0.25|0.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.30|-0.25|0.8580
73902276|NCT02038829|147334535|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0842|STANDARD_ERROR_OF_MEAN|0.0185|<|0.0001|TWO_SIDED|95.0|0.0478|0.1206|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1206|0.0478|<0.0001
73902277|NCT02038829|147334535|NON_INFERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1255|STANDARD_ERROR_OF_MEAN|0.0186|<|0.0001|TWO_SIDED|95.0|0.089|0.1621|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1621|0.0890|<0.0001
73902278|NCT02038829|147334535|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1963|STANDARD_ERROR_OF_MEAN|0.0184|<|0.0001|TWO_SIDED|95.0|0.1601|0.2325|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2325|0.1601|<0.0001
73902279|NCT02038829|147334535|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1902|STANDARD_ERROR_OF_MEAN|0.0186|<|0.0001|TWO_SIDED|95.0|0.1537|0.2268|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2268|0.1537|<0.0001
73902280|NCT00998764|147334540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.324|TWO_SIDED|95.0|-0.74|2.23|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 13||2.23|-0.74|0.324
73902281|NCT00998764|147334540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.723|TWO_SIDED|95.0|-1.33|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 26||1.92|-1.33|0.723
73902282|NCT00998764|147334540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.966|TWO_SIDED|95.0|-1.81|1.89|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 39||1.89|-1.81|0.966
73902283|NCT00998764|147334540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-1.93|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 52||1.92|-1.93|0.996
73902284|NCT00998764|147334540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.336|TWO_SIDED|95.0|-3.67|1.26|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 78||1.26|-3.67|0.336
73902285|NCT00998764|147334541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.737|TWO_SIDED|95.0|-1.11|0.79|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 13||0.79|-1.11|0.737
73902286|NCT00998764|147334541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.213|TWO_SIDED|95.0|-1.76|0.4|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 26||0.40|-1.76|0.213
73902287|NCT00998764|147334541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.168|TWO_SIDED|95.0|-2.19|0.38|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 39||0.38|-2.19|0.168
73902288|NCT00998764|147334541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.197|TWO_SIDED|95.0|-2.3|0.48|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 52||0.48|-2.30|0.197
73902289|NCT00998764|147334541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.044|TWO_SIDED|95.0|-4.21|0.06|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 78||0.06|-4.21|0.044
73961936|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.043||||0.506|TWO_SIDED|95.0|-0.087|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 52|||0.172|-0.087|0.506
73902290|NCT00998764|147334542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.077|TWO_SIDED|95.0|-6.3|0.33|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 13||0.33|-6.30|0.077
73961937|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.051||||0.223|TWO_SIDED|95.0|-0.032|0.134||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 2|||0.134|-0.032|0.223
73961938|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046||||0.276|TWO_SIDED|95.0|-0.037|0.129||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 4|||0.129|-0.037|0.276
73852022|NCT04283656|147251961|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.7|1.35||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for estradiol AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.35|0.70|
73852023|NCT04283656|147251962|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.12|||||TWO_SIDED|90.0|0.92|1.36||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratios for estradiol Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.36|0.92|
73852024|NCT04283656|147251963|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.09|||||TWO_SIDED|90.0|0.88|1.35||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratios for estradiol C12 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.35|0.88|
73852025|NCT00394329|147251964|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.56|STANDARD_ERROR_OF_MEAN|0.28||0.066|TWO_SIDED|95.0|0.32|0.96||Hochberg adjustment was applied to the p-value to account for each of three active group comparisons to the placebo group. The unadjusted p-value is 0.033.|Regression, Cox|||||0.96|0.32|0.066
73852026|NCT00935493|147251974|SUPERIORITY_OR_OTHER|||||||0.06|||||||Regression, Linear|||||||0.06
73852027|NCT00935493|147251974|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Linear|||||||0.47
73852028|NCT00935493|147251975|SUPERIORITY_OR_OTHER|||||||0.67|||||||Regression, Logistic|||||||0.67
73852029|NCT00935493|147251975|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Logistic|||||||0.46
73852030|NCT00935493|147251976|SUPERIORITY_OR_OTHER|||||||0.65|||||||Regression, Linear|||||||0.65
73902291|NCT00998764|147334542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67||||0.117|TWO_SIDED|95.0|-6.02|0.67|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 26||0.67|-6.02|0.117
73902292|NCT00998764|147334542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.063|TWO_SIDED|95.0|-7.38|0.19|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 39||0.19|-7.38|0.063
73902293|NCT00998764|147334542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.412|TWO_SIDED|95.0|-5.95|2.44|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 52||2.44|-5.95|0.412
73852031|NCT00935493|147251976|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Linear|||||||0.46
73852032|NCT02565147|147251995|SUPERIORITY|||||||0.7505|||||||Wilcoxon Rank Sum Test|||||||0.7505
73852033|NCT03587428|147252004|SUPERIORITY||Mean Difference (Final Values)|-0.3252||||0.1787|TWO_SIDED|95.0|-0.8101|0.1596|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.|||0.1596|-0.8101|0.1787
73852034|NCT03587428|147252004|SUPERIORITY||Mean Difference (Final Values)|-0.7037||||0.0063|TWO_SIDED|95.0|-1.1886|-0.2187|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.|||-0.2187|-1.1886|0.0063
73852035|NCT03423238|147252026|SUPERIORITY|||||||0.388|||||||t-test, 2 sided|||Baseline||||0.388
73852036|NCT03423238|147252027|SUPERIORITY|||||||0.017|||||||ANCOVA|||Month 3||||0.017
73852037|NCT03423238|147252027|SUPERIORITY|||||||0.002|||||||ANCOVA|||Month 6||||0.002
73852038|NCT03423238|147252028|SUPERIORITY|||||||0.653|||||||t-test, 2 sided|||Baseline||||0.653
73852039|NCT03423238|147252029|SUPERIORITY|||||||0.684|||||||ANCOVA|||Month 3||||0.684
73852040|NCT03423238|147252029|SUPERIORITY|||||||0.458|||||||ANCOVA|||Month 6||||0.458
73852041|NCT03423238|147252030|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Baseline||||0.550
73852042|NCT03423238|147252031|SUPERIORITY|||||||0.973|||||||ANCOVA|||Month 3||||0.973
73852043|NCT03423238|147252031|SUPERIORITY|||||||0.432|||||||ANCOVA|||Month 6||||0.432
73852044|NCT03423238|147252032|SUPERIORITY|||||||0.23063|||||||t-test, 2 sided|||Baseline||||0.23063
73852045|NCT03423238|147252033|SUPERIORITY|||||||0.854|||||||ANCOVA|||Month 3||||0.854
73852046|NCT03423238|147252033|SUPERIORITY|||||||0.874|||||||ANCOVA|||Month 6||||0.874
73852047|NCT03423238|147252034|SUPERIORITY|||||||0.563|||||||t-test, 2 sided|||Baseline||||0.563
73852048|NCT03423238|147252035|SUPERIORITY|||||||0.008|||||||ANCOVA|||Month 3||||0.008
73902294|NCT00998764|147334542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.78||||0.321|TWO_SIDED|95.0|-8.28|2.73|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 78||2.73|-8.28|0.321
73902295|NCT00998764|147334543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.329|TWO_SIDED|95.0|-3.24|1.09|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 13||1.09|-3.24|0.329
74024426|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.486|TWO_SIDED|95.0|-0.24|0.11|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.11|-0.24|0.486
73852049|NCT03423238|147252035|SUPERIORITY|||||||0.922|||||||ANCOVA|||Month 6||||0.922
73852050|NCT03423238|147252036|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||Baseline||||0.667
73852051|NCT03423238|147252037|SUPERIORITY|||||||0.692|||||||ANCOVA|||Month 3||||0.692
73852052|NCT03423238|147252037|SUPERIORITY|||||||0.59|||||||ANCOVA|||Month 6||||0.590
73852053|NCT03423238|147252038|SUPERIORITY|||||||0.844|||||||t-test, 2 sided|||Baseline||||0.844
73852054|NCT03423238|147252039|SUPERIORITY|||||||0.721|||||||ANCOVA|||Month 3||||0.721
73852055|NCT03423238|147252039|SUPERIORITY|||||||0.851|||||||ANCOVA|||Month 6||||0.851
73852056|NCT03423238|147252040|SUPERIORITY|||||||0.815|||||||t-test, 2 sided|||Baseline||||0.815
73852057|NCT03423238|147252041|SUPERIORITY|||||||0.488|||||||ANCOVA|||Month 3||||0.488
73852058|NCT03423238|147252041|SUPERIORITY|||||||0.237|||||||ANCOVA|||Month 6||||0.237
73852059|NCT03423238|147252042|SUPERIORITY|||||||0.506|||||||t-test, 2 sided|||||||0.506
73852060|NCT03423238|147252043|SUPERIORITY|||||||0.549|||||||ANCOVA|||Month 3||||0.549
73852061|NCT03423238|147252043|SUPERIORITY|||||||0.303|||||||ANCOVA|||Month 6||||0.303
73852062|NCT03423238|147252044|SUPERIORITY|||||||0.934|||||||t-test, 2 sided|||Baseline||||0.934
73852063|NCT03423238|147252045|SUPERIORITY|||||||0.792|||||||ANCOVA|||Month 3||||0.792
73852064|NCT03423238|147252045|SUPERIORITY|||||||0.417|||||||ANCOVA|||Month 6||||0.417
73852065|NCT03423238|147252046|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||Baseline||||0.685
73852066|NCT03423238|147252047|SUPERIORITY|||||||0.854|||||||ANCOVA|||Month 3||||0.854
73852067|NCT03423238|147252047|SUPERIORITY|||||||0.903|||||||ANCOVA|||Month 6||||0.903
73852068|NCT03423238|147252048|SUPERIORITY|||||||0.569|||||||t-test, 2 sided|||Baseline||||0.569
73852069|NCT03423238|147252049|SUPERIORITY|||||||0.824|||||||ANCOVA|||Month 3||||0.824
73852070|NCT03423238|147252049|SUPERIORITY|||||||0.401|||||||ANCOVA|||Month 6||||0.401
73852071|NCT03423238|147252050|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||Baseline||||0.188
73852072|NCT03423238|147252051|SUPERIORITY|||||||0.338|||||||ANCOVA|||Month 3||||0.338
73852073|NCT03423238|147252051|SUPERIORITY|||||||0.484|||||||ANCOVA|||Month 6||||0.484
73852074|NCT03423238|147252052|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||Baseline||||0.533
73852075|NCT03423238|147252053|SUPERIORITY|||||||0.992|||||||ANCOVA|||Month 3||||0.992
73852076|NCT03423238|147252053|SUPERIORITY|||||||0.639|||||||ANCOVA|||Month 6||||0.639
73852077|NCT03745638|147252056|SUPERIORITY||Odds Ratio (OR)|6.38|||<|0.0001|TWO_SIDED|95.0|3.556|11.923||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||11.923|3.556|< 0.0001
73852078|NCT03745638|147252056|SUPERIORITY||Odds Ratio (OR)|7.5|||<|0.0001|TWO_SIDED|95.0|4.178|14.04||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||14.040|4.178|< 0.0001
73852079|NCT03745638|147252057|SUPERIORITY||Odds Ratio (OR)|4.04|||<|0.0001|TWO_SIDED|95.0|2.441|6.808||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||6.808|2.441|< 0.0001
73852080|NCT03745638|147252057|SUPERIORITY||Odds Ratio (OR)|5.22|||<|0.0001|TWO_SIDED|95.0|3.145|8.831||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||8.831|3.145|< 0.0001
73852081|NCT03745638|147252058|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0002|TWO_SIDED|95.0|1.773|8.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||8.083|1.773|0.0002
73852082|NCT03745638|147252058|SUPERIORITY||Odds Ratio (OR)|6.01|||<|0.0001|TWO_SIDED|95.0|2.931|13.22||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.220|2.931|< 0.0001
73852083|NCT03745638|147252059|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0081|TWO_SIDED|95.0|1.242|5.723||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||5.723|1.242|0.0081
73852084|NCT03745638|147252059|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0039|TWO_SIDED|95.0|1.334|6.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||6.083|1.334|0.0039
73852085|NCT03745638|147252060|SUPERIORITY||Odds Ratio (OR)|1.67||||0.1421|TWO_SIDED|95.0|0.862|3.391||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.391|0.862|0.1421
73852086|NCT03745638|147252060|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0746|TWO_SIDED|95.0|0.949|3.665||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.665|0.949|0.0746
73852087|NCT03745638|147252070|SUPERIORITY||Least Squares Mean Difference|-35.48|STANDARD_ERROR_OF_MEAN|4.16|<|0.0001|TWO_SIDED|95.0|-43.64|-27.32|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-27.32|-43.64|< 0.0001
73902296|NCT00998764|147334543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.601|TWO_SIDED|95.0|-3.31|1.92|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 26||1.92|-3.31|0.601
73902297|NCT00998764|147334543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.328|TWO_SIDED|95.0|-4.67|1.56|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 39||1.56|-4.67|0.328
73902298|NCT00998764|147334543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.68|TWO_SIDED|95.0|-2.7|4.13|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 52||4.13|-2.70|0.680
73902299|NCT00998764|147334543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.954|TWO_SIDED|95.0|-5.05|4.77|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 78||4.77|-5.05|0.954
73902300|NCT00998764|147334544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.931|TWO_SIDED|95.0|-2.4|2.62|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 26.||2.62|-2.40|0.931
73902301|NCT00998764|147334544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.524|TWO_SIDED|95.0|-3.26|1.67|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 52.||1.67|-3.26|0.524
73902302|NCT00998764|147334544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03||||0.353|TWO_SIDED|95.0|-6.32|2.27|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 78.||2.27|-6.32|0.353
73902303|NCT00998764|147334545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.531|TWO_SIDED|95.0|-2.92|1.51|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 26.||1.51|-2.92|0.531
73902304|NCT00998764|147334545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84||||0.137|TWO_SIDED|95.0|-4.28|0.59|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 52.||0.59|-4.28|0.137
73902305|NCT00998764|147334545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.128|TWO_SIDED|95.0|-7.6|0.96|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 78.||0.96|-7.60|0.128
73902306|NCT00998764|147334546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.811|TWO_SIDED|95.0|-0.49|0.63|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 6.||0.63|-0.49|0.811
73902307|NCT00998764|147334546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.681|TWO_SIDED|95.0|-0.45|0.69|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 19.||0.69|-0.45|0.681
73902308|NCT00998764|147334546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.742|TWO_SIDED|95.0|-0.51|0.72|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.||0.72|-0.51|0.742
74024427|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.42|-0.06|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-0.42|0.008
74024428|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.64|-0.28|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-0.64|<0.001
73902309|NCT00998764|147334546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.598|TWO_SIDED|95.0|-0.48|0.83|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.||0.83|-0.48|0.598
73902310|NCT00998764|147334546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.922|TWO_SIDED|95.0|-0.85|0.77|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.||0.77|-0.85|0.922
73902311|NCT00998764|147334547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.099|TWO_SIDED|95.0|-0.08|0.9|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 6.||0.90|-0.08|0.099
73902312|NCT00998764|147334547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.089|TWO_SIDED|95.0|-0.07|1.01|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 19.||1.01|-0.07|0.089
73902313|NCT00998764|147334547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.152|TWO_SIDED|95.0|-0.17|1.08|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.||1.08|-0.17|0.152
73902314|NCT00998764|147334547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.16|TWO_SIDED|95.0|-0.21|1.25|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.||1.25|-0.21|0.160
73902315|NCT00998764|147334547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.603|TWO_SIDED|95.0|-0.73|1.26|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.||1.26|-0.73|0.603
73902316|NCT01933789|147334550|SUPERIORITY||Probit regression coefficient|1.145|||<|0.001|TWO_SIDED|95.0|0.844|1.446||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.446|0.844|<0.001
73902317|NCT01933789|147334551|SUPERIORITY||Probit regression coefficient|1.251|||<|0.001|TWO_SIDED|95.0|0.92|1.583||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.583|0.920|<0.001
73902318|NCT01933789|147334552|SUPERIORITY||Probit regression coefficient|1.381|||<|0.001|TWO_SIDED|95.0|1.046|1.715||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.715|1.046|<0.001
73902319|NCT01933789|147334554|SUPERIORITY||Probit regression coefficient|0.334||||0.073|TWO_SIDED|95.0|-0.031|0.699||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient's treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.|Occurrence of goal-concordant care||0.699|-0.031|0.073
74024429|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.62|-0.26|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.26|-0.62|<0.001
74024430|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.75|-0.39|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.75|<0.001
73852088|NCT03745638|147252070|SUPERIORITY||Least Squares Method of Mean Difference]|-40.29|STANDARD_ERROR_OF_MEAN|4.15|<|0.0001|TWO_SIDED|95.0|-48.44|-32.13|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-32.13|-48.44|< 0.0001
73852089|NCT03745638|147252070|SUPERIORITY||Least Squares Mean Difference|-45.01|STANDARD_ERROR_OF_MEAN|4.72|<|0.0001|TWO_SIDED|95.0|-54.28|-35.74|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-35.74|-54.28|< 0.0001
73852090|NCT03745638|147252070|SUPERIORITY||Least Squares Mean Difference|-48.05|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-57.3|-38.79|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-38.79|-57.30|< 0.0001
73852091|NCT03745638|147252070|SUPERIORITY||Least Squares Mean Difference|-33.13|STANDARD_ERROR_OF_MEAN|4.49|<|0.0001|TWO_SIDED|95.0|-41.95|-24.3||The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.|Mixed-Model with Repeated Measures|||Percent change from Baseline in EASI score at Week 8||-24.30|-41.95|< 0.0001
73852092|NCT03745638|147252070|SUPERIORITY||Least Squares Mean Difference|-39.52|STANDARD_ERROR_OF_MEAN|4.48|<|0.0001|TWO_SIDED|95.0|-48.32|-30.72|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-30.72|-48.32|< 0.0001
73852093|NCT03745638|147252071|SUPERIORITY||Least Squares Mean Difference|-25.3|STANDARD_ERROR_OF_MEAN|3.74|<|0.0001|TWO_SIDED|95.0|-32.62|-17.95|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-17.95|-32.62|< 0.0001
73852094|NCT03745638|147252071|SUPERIORITY||Least Squares Mean Difference|-30.4|STANDARD_ERROR_OF_MEAN|3.72|<|0.0001|TWO_SIDED|95.0|-37.68|-23.06|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-23.06|-37.68|< 0.0001
73852095|NCT03745638|147252072|SUPERIORITY||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.87|-0.91|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-0.91|-1.87|<0.0001
73902320|NCT01933789|147334555|SUPERIORITY||Probit regression coefficient|0.481||||0.017|TWO_SIDED|95.0|0.085|0.877||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient's treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.|||0.877|0.085|0.017
73902321|NCT01933789|147334556|SUPERIORITY||Probit regression coefficient|2.022||||0.01|TWO_SIDED|95.0|0.476|3.569||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the latent variable as measured at baseline.|Control group coded 0; intervention group coded 1.|||3.569|0.476|0.010
73902322|NCT01933789|147334557|SUPERIORITY||Tobit regression coefficient|2.209||||0.001|TWO_SIDED|95.0|0.939|3.479||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's feelings about getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."||3.479|0.939|0.001
73852096|NCT03745638|147252072|SUPERIORITY||Least Squares Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.11|-1.16|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.16|-2.11|<0.0001
73852097|NCT03745638|147252072|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.25|-1.15|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.15|-2.25|<0.0001
73852098|NCT03745638|147252072|SUPERIORITY||Least Squares Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.63|-1.53|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.53|-2.63|<0.0001
73852099|NCT03745638|147252072|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.2|-1.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.01|-2.20|<0.0001
73852100|NCT03745638|147252072|SUPERIORITY||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.58|-1.4|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.40|-2.58|<0.0001
73852101|NCT03745638|147252074|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.74|-0.74|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.74|-1.74|<0.0001
74024431|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.53|-0.16|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.16|-0.53|<0.001
73902323|NCT01933789|147334557|SUPERIORITY||Tobit regression coefficient|1.237||||0.122|TWO_SIDED|95.0|-0.33|2.804||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about details of getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."||2.804|-0.330|0.122
73902324|NCT01933789|147334557|SUPERIORITY||Tobit regression coefficient|2.329||||0.098|TWO_SIDED|95.0|-0.426|5.083||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about how long the patient might have to live.~Variable with range 0-11, defined as censored from below because of strong floor effect."||5.083|-0.426|0.098
73902325|NCT01933789|147334557|SUPERIORITY||Tobit regression coefficient|1.573||||0.352|TWO_SIDED|95.0|-1.742|4.887||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Adjusted for outcome variable as measured at baseline: pt. minority status, education, income; clinician type \& specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about what dying might be like.~Variable with range 0-11, defined as censored from below because of strong floor effect."||4.887|-1.742|0.352
73902326|NCT01933789|147334557|SUPERIORITY||Tobit regression coefficient|4.625|||<|0.001|TWO_SIDED|95.0|2.06|7.19||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's involvement in end-of-life treatment decisions.~Variable with range 0-11, defined as censored from below because of strong floor effect."||7.190|2.060|<0.001
73902327|NCT01933789|147334557|SUPERIORITY||Tobit regression coefficient|2.404||||0.002|TWO_SIDED|95.0|0.898|3.909||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about things in life that are important to the patient.~Variable with range 0-11, defined as censored from below because of strong floor effect."||3.909|0.898|0.002
73902328|NCT01933789|147334557|SUPERIORITY||Tobit regression coefficient|2.455||||0.075|TWO_SIDED|95.0|-0.25|5.159||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician type.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's religious/spiritual beliefs.~Variable with range 0-11, defined as censored from below because of strong floor effect."||5.159|-0.250|0.075
73902329|NCT01933789|147334558|SUPERIORITY||Probit regression coefficient|-0.103||||0.369|TWO_SIDED|95.0|-0.327|0.122||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent depression variable and for the patient racial/ethnic minority status.|Control group coded 0; intervention group coded 1.|Symptoms of depression - Two-indicator latent variable with measurement invariance imposed between groups and over time.||0.122|-0.327|0.369
73902330|NCT01933789|147334559|SUPERIORITY||Probit regression coefficient|0.263||||0.536|TWO_SIDED|95.0|-0.571|1.097||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score.|Control group coded 0; intervention group coded 1.|Symptoms of depression: standard PHQ-8 composite score.||1.097|-0.571|0.536
73902331|NCT01933789|147334560|SUPERIORITY||Probit regression coefficient|0.208||||0.106|TWO_SIDED|95.0|-0.044|0.461||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Pts clustered under clins. Adjusted for baseline level of the latent depression var; pt age, minority status, education, health status; clin specialty|Control group coded 0; intervention group coded 1.|Symptoms of depression: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.461|-0.044|0.106
73902332|NCT01933789|147334561|SUPERIORITY||Probit regression coefficient|0.446||||0.343|TWO_SIDED|95.0|-0.476|1.368||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score and clinician specialty.|Control group coded 0; intervention group coded 1.|Symptoms of depression: Standard PHQ-8 composite score||1.368|-0.476|0.343
73902333|NCT01933789|147334562|SUPERIORITY||Probit regression coefficient|-0.034||||0.734|TWO_SIDED|95.0|-0.232|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.163|-0.232|0.734
73961939|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.075||||0.131|TWO_SIDED|95.0|-0.023|0.173||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 8|||0.173|-0.023|0.131
73961940|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.003||||0.949|TWO_SIDED|95.0|-0.084|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 12|||0.090|-0.084|0.949
74024432|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.22|-0.58|<0.001
74024433|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.89|-0.52|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.52|-0.89|<0.001
73852102|NCT03745638|147252074|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-2.11|-1.13|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-1.13|-2.11|<0.0001
73852103|NCT03745638|147252077|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.54||0.0049|TWO_SIDED|95.0|-2.6|-0.47|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||-0.47|-2.60|0.0049
73852104|NCT03745638|147252077|SUPERIORITY||Least Squares Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.37|-1.25|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||-1.25|-3.37|<0.0001
73852105|NCT03745638|147252077|SUPERIORITY||Least Squares Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.6||0.0001|TWO_SIDED|95.0|-3.52|-1.15|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||-1.15|-3.52|0.0001
73852106|NCT03745638|147252077|SUPERIORITY||Least Squares Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.03|-1.67|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||-1.67|-4.03|<0.0001
73852107|NCT03745638|147252077|SUPERIORITY||Least Squares Mean Difference|-2.54|STANDARD_ERROR_OF_MEAN|0.71||0.0004|TWO_SIDED|95.0|-3.93|-1.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||-1.14|-3.93|0.0004
74024434|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.59|-0.22|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.22|-0.59|<0.001
74024435|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.55|-0.18|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
74024436|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.83|-0.46|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.46|-0.83|<0.001
73852108|NCT03745638|147252077|SUPERIORITY||Least Squares Mean Difference|-3.18|STANDARD_ERROR_OF_MEAN|0.71|<|0.0001|TWO_SIDED|95.0|-4.57|-1.79|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||-1.79|-4.57|<0.0001
73852109|NCT03745638|147252078|SUPERIORITY||Least Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.6||0.0487|TWO_SIDED|95.0|-2.35|-0.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.01|-2.35|0.0487
73852110|NCT03745638|147252078|SUPERIORITY||Least Squares Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.59||0.0049|TWO_SIDED|95.0|-2.84|-0.51|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.51|-2.84|0.0049
73852111|NCT03745638|147252078|SUPERIORITY||Least Squares Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.66||0.0128|TWO_SIDED|95.0|-2.94|-0.35|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.35|-2.94|0.0128
73852112|NCT03745638|147252078|SUPERIORITY||Least Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.66||0.0037|TWO_SIDED|95.0|-3.2|-0.62|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.62|-3.20|0.0037
73852113|NCT03745638|147252078|SUPERIORITY||Least Squares Mean Difference|-2.11|STANDARD_ERROR_OF_MEAN|0.75||0.0048|TWO_SIDED|95.0|-3.58|-0.65|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||-0.65|-3.58|0.0048
73852114|NCT03745638|147252078|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.74||0.002|TWO_SIDED|95.0|-3.75|-0.84|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||-0.84|-3.75|0.0020
73852115|NCT03745638|147252081|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.07|-2.18|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.18|-4.07|<0.0001
73852116|NCT03745638|147252081|SUPERIORITY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.67|-2.79|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.79|-4.67|<0.0001
74024437|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.47|-0.09|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.09|-0.47|0.004
73852117|NCT03745638|147252083|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-6.43|-3.8|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-3.80|-6.43|<0.0001
73852118|NCT03745638|147252083|SUPERIORITY||Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-7.62|-5.0|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-5.00|-7.62|<0.0001
73852119|NCT03745638|147252085|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.85|-2.68|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-2.68|-4.85|<0.0001
73852120|NCT03745638|147252085|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-5.56|-3.42|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-3.42|-5.56|<0.0001
73852121|NCT03745638|147252087|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.01||0.0018|TWO_SIDED|95.0|-5.29|-1.26|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-1.26|-5.29|0.0018
73852122|NCT03745638|147252087|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.08||0.0378|TWO_SIDED|95.0|-4.43|-0.13|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-0.13|-4.43|0.0378
73852123|NCT03745638|147252091|SUPERIORITY||Odds Ratio (OR)|6.28|||<|0.0001|TWO_SIDED|95.0|3.632|11.018||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||11.018|3.632|<0.0001
73852124|NCT03745638|147252091|SUPERIORITY||Odds Ratio (OR)|8.39|||<|0.0001|TWO_SIDED|95.0|4.755|15.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||15.083|4.755|<0.0001
73852125|NCT03745638|147252092|SUPERIORITY||Least Squares Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|1.67||0.0037|TWO_SIDED|95.0|1.59|8.15|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.15|1.59|0.0037
74024438|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.17|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.55|<0.001
73852126|NCT03745638|147252092|SUPERIORITY||Least Squares Mean Difference|5.7|STANDARD_ERROR_OF_MEAN|1.66||0.0006|TWO_SIDED|95.0|2.45|8.96|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.96|2.45|0.0006
73852127|NCT03745638|147252093|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|3.34||0.1417|TWO_SIDED|95.0|-11.49|1.65|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||1.65|-11.49|0.1417
73852128|NCT03745638|147252093|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|3.29||0.6037|TWO_SIDED|95.0|-8.19|4.77|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||4.77|-8.19|0.6037
73852129|NCT03745638|147252093|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|2.99||0.0003|TWO_SIDED|95.0|-16.89|-5.12|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.12|-16.89|0.0003
73852130|NCT03745638|147252093|SUPERIORITY||Least Squares Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|2.93|<|0.0001|TWO_SIDED|95.0|-17.98|-6.47|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.47|-17.98|<0.0001
73852131|NCT03745638|147252093|SUPERIORITY||Least Squares Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|3.85|<|0.0001|TWO_SIDED|95.0|-22.95|-7.81|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.81|-22.95|<0.0001
73852132|NCT03745638|147252093|SUPERIORITY||Least Squares Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|3.77||0.0011|TWO_SIDED|95.0|-19.85|-5.01|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.01|-19.85|0.0011
73852133|NCT03745638|147252093|SUPERIORITY||Least Squares Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|2.13|<|0.0001|TWO_SIDED|95.0|-14.64|-6.29|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.29|-14.64|<0.0001
73852134|NCT03745638|147252093|SUPERIORITY||Least Squares Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED|95.0|-16.6|-8.29|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-8.29|-16.60|<0.0001
73852135|NCT02168062|147252132|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||||||0.109
73852136|NCT02168062|147252134|OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Systolic Blood Pressure measurement comparison||||0.85
74024439|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.39|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.77|<0.001
73852137|NCT02168062|147252134|OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Diastolic Blood Pressure measurement comparison||||0.10
73852138|NCT02168062|147252135|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Weight measurement comparison||||0.70
73852139|NCT02168062|147252136|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Percentage body fat measurement comparison||||0.11
73852140|NCT02168062|147252137|OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Waist measurement comparison||||0.32
73852141|NCT02168062|147252138|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Hemoglobin A1C measurement comparison||||0.70
73852142|NCT02168062|147252139|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Insulin resistance score comparison||||0.46
73852143|NCT02168062|147252140|OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Total Cholesterol measurement comparison||||0.44
73852144|NCT02168062|147252140|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Total low density lipid measurement comparison||||0.52
73852145|NCT02168062|147252140|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Total high density lipid measurement comparison||||0.40
73852146|NCT02168062|147252140|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Total triglyceride measurement comparison||||0.53
73852147|NCT02168062|147252141|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Non-vigorous physical activity comparison||||0.38
73852148|NCT02168062|147252141|OTHER|||||||0.979|||||||Wilcoxon (Mann-Whitney)|||Moderate physical activity comparison||||0.979
73852149|NCT02168062|147252141|OTHER|||||||0.884|||||||Wilcoxon (Mann-Whitney)|||Moderate-Vigorous physical activity comparison||||0.884
73852150|NCT02168062|147252141|OTHER|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Vigorous physical activity comparison||||0.678
73852151|NCT02168062|147252141|OTHER|||||||0.464|||||||Wilcoxon (Mann-Whitney)|||Total physical activity comparison||||0.464
73852152|NCT02168062|147252142|OTHER|||||||0.838|||||||Wilcoxon (Mann-Whitney)|||Average MVPA Minutes per Day Comparison||||0.838
73852153|NCT02168062|147252143|OTHER|||||||0.677|||||||Wilcoxon (Mann-Whitney)|||Bone Density at the lumbar spine comparison||||0.677
73852154|NCT02168062|147252143|OTHER|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||Bone Density at the femoral neck comparison||||0.493
73852155|NCT02168062|147252143|OTHER|||||||0.807|||||||Wilcoxon (Mann-Whitney)|||Bone Density of the total hip comparison||||0.807
73852156|NCT02168062|147252144|OTHER|||||||0.403|||||||Wilcoxon (Mann-Whitney)|||Serum 25-(OH) vitamin D level comparison||||0.403
73852157|NCT02168062|147252145|OTHER|||||||0.385|||||||Wilcoxon (Mann-Whitney)|||||||.385
73852158|NCT02168062|147252146|OTHER|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||Attention Function Index (AFI) Score Comparison||||.148
73852159|NCT02168062|147252147|OTHER|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||Mental Composite Score Comparison||||.077
73852160|NCT02168062|147252147|OTHER|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||Physical Composite Score Comparison||||0.401
73852161|NCT02168062|147252148|OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
73852162|NCT02168062|147252149|OTHER|||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||0.676
73852163|NCT02168062|147252150|OTHER|||||||0.183|||||||Wilcoxon (Mann-Whitney)|||||||0.183
73852164|NCT02168062|147252151|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Total Score Comparison||||0.66
73852165|NCT02168062|147252151|OTHER|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Urinary Incontinence Score Comparison||||0.844
73852166|NCT02168062|147252151|OTHER|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Urinary Irriation Score Comparison||||0.175
73852167|NCT02168062|147252151|OTHER|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Bowel Function Score Comparison||||0.472
73852168|NCT02168062|147252151|OTHER|||||||0.405|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Sexual Function Score Comparison||||0.405
73852169|NCT02168062|147252151|OTHER|||||||0.749|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Hormonal Function Score Comparison||||0.749
73852170|NCT02168062|147252152|OTHER|||||||0.907|||||||Wilcoxon (Mann-Whitney)|||Fatigue Scale Score Comparison||||0.907
73852171|NCT02168062|147252152|OTHER|||||||0.792|||||||Wilcoxon (Mann-Whitney)|||Energy Scale Score Comparison||||0.792
73852172|NCT00923351|147252232|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Fisher Exact|||||||0.043
73852173|NCT00940290|147252235|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Kruskal-Wallis|||After reading the clinical practice guideline, the median response from the four groups were compared using the Kruskal-Wallis statistic||||0.007
73852174|NCT00851890|147252296|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.012
73852175|NCT00851890|147252296|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.071
73852176|NCT00851890|147252296|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.140
73852177|NCT00851890|147252297|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.008
73852178|NCT00851890|147252297|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.003
73852179|NCT00851890|147252297|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.009
73852180|NCT00851890|147252304|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.018
73852181|NCT00851890|147252304|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.020
73852182|NCT00851890|147252304|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.054
73852183|NCT00851890|147252304|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.010
74024440|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.1||0.09|TWO_SIDED|95.0|-0.37|0.03|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.03|-0.37|0.090
73852184|NCT00851890|147252304|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.005
73852185|NCT00851890|147252304|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.014
73852186|NCT00851890|147252305|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.026
73852187|NCT00851890|147252305|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.026
73852188|NCT00851890|147252305|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.138
73852189|NCT00851890|147252306|SUPERIORITY_OR_OTHER|||||||0.209|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.209
73852190|NCT00851890|147252306|SUPERIORITY_OR_OTHER|||||||0.473|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.473
73852191|NCT00851890|147252306|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.031
73852192|NCT00851890|147252307|SUPERIORITY_OR_OTHER|||||||0.209|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.209
73852193|NCT00851890|147252307|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||1.000
73852194|NCT03135431|147252310|NON_INFERIORITY|\<=.5g/dl difference in the decrease in hemoglobin was considered equivalent as 1 unit of blood typically raises the hemoglobin by 1g/dl and would be a clinical significant difference.|Mean Difference (Final Values)|-0.04121||||0.08|ONE_SIDED|95.0||0.0712|||t-test, 1 sided|||Assuming that a difference of 0.5 g/dl in the drop in hemoglobin between study arms would be considered as equivalent, and assuming a common standard deviation of 1.1 based on previous studies of cesarean deliveries deliveries , the study would have 80% power to test for non-inferiority with 60 participants in each arm (120 total).|Based on new data from a retrospective study preformed at Mayo Clinic sites an additional power calculation was preformed. Based on the new information, our study was well powered (84%) to assess our primary aim with 38 participants (18 salpingectomy, 20 BTL); therefore, we discontinued recruitment and completed the study with the accrued subjects.|.0712||0.08
73852195|NCT03135431|147252311|SUPERIORITY||Mean Difference (Final Values)|-11.21|||||TWO_SIDED|95.0|-14.1|-8.3|||||Evidence to suggest salpingecotomy procedure had a longer operation time than a tubal ligation.|||-8.3|-14.1|
73852196|NCT03135431|147252312|SUPERIORITY||Mean Difference (Net)|-9.17||||0.77|TWO_SIDED|95.0|-72.5|54.17|||t-test, 2 sided|||Analysis preformed as categorical and categorical variable. Both analyzes had the same conclusion.||54.17|-72.5|0.77
73902334|NCT01933789|147334563|SUPERIORITY||Tobit regression coefficient|0.041||||0.935|TWO_SIDED|95.0|-0.946|1.028||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Clustered Tobit regression because strong floor effect on composite score. Adjusted for baseline level of composite score.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Standard GAD-7 composite score||1.028|-0.946|0.935
74024441|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.053|TWO_SIDED|95.0|-0.39|0.0|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.00|-0.39|0.053
73961941|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.259|TWO_SIDED|95.0|-0.044|0.163||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 18|||0.163|-0.044|0.259
73961942|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.152|TWO_SIDED|95.0|-0.027|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 26|||0.172|-0.027|0.152
73961943|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.114||||0.076|TWO_SIDED|95.0|-0.012|0.241||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 39|||0.241|-0.012|0.076
73961944|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.171||||0.107|TWO_SIDED|95.0|-0.038|0.381||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 52|||0.381|-0.038|0.107
73961945|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.484|TWO_SIDED|95.0|-0.046|0.097||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 2|||0.097|-0.046|0.484
73961946|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037||||0.256|TWO_SIDED|95.0|-0.027|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 4|||0.100|-0.027|0.256
73961947|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052||||0.184|TWO_SIDED|95.0|-0.025|0.128||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 8|||0.128|-0.025|0.184
73961948|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001||||0.97|TWO_SIDED|95.0|-0.077|0.074||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 12|||0.074|-0.077|0.970
73961949|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.608|TWO_SIDED|95.0|-0.07|0.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 18|||0.120|-0.070|0.608
74084767|NCT00462839|147722944|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Post-hoc comparison of 500ml, 1000ml and 2000ml volumes were greater in the non-calibrated drape first group. Post-hoc comparisons made using Bonferroni correct t-test for 8 comparisons.|ANOVA|||Repeated measures ANOVA comparing all levels of blood estimation (P=0.0002). Post-hoc comparisons using Bonferroni corrects t-tests.||||<0.05
73961950|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084||||0.071|TWO_SIDED|95.0|-0.007|0.175||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 26|||0.175|-0.007|0.071
73961951|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028||||0.622|TWO_SIDED|95.0|-0.085|0.141||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 39|||0.141|-0.085|0.622
73961952|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.102||||0.277|TWO_SIDED|95.0|-0.086|0.291||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 52|||0.291|-0.086|0.277
73961953|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.056||||0.241|TWO_SIDED|95.0|-0.038|0.15||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 2|||0.150|-0.038|0.241
74084768|NCT00462839|147722945|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Chi-squared, Corrected|||||||0.76
73961954|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.348|TWO_SIDED|95.0|-0.049|0.14|||MMRM||FVC Pre-dose, Week 4|||0.140|-0.049|0.348
73961955|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.138|TWO_SIDED|95.0|-0.024|0.169||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 8|||0.169|-0.024|0.138
73961956|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012||||0.813|TWO_SIDED|95.0|-0.111|0.087||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 12|||0.087|-0.111|0.813
73961957|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.172|TWO_SIDED|95.0|-0.032|0.177||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 18|||0.177|-0.032|0.172
74084769|NCT00462839|147722946|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Chi-squared, Corrected|||||||0.72
74084770|NCT00462839|147722947|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Chi-squared, Corrected|||||||0.89
73902335|NCT01933789|147334564|SUPERIORITY||Probit regression coefficient|-0.042||||0.689|TWO_SIDED|95.0|-0.247|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.163|-0.247|0.689
73902336|NCT01933789|147334565|SUPERIORITY||Tobit regression coefficient|-0.105||||0.852|TWO_SIDED|95.0|-1.204|0.995||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians. Clustered Tobit regression because of strong floor effect on composite score."|Clustered Tobit regression|Adjusted for baseline level of the GAD-7 composite score.|Control group coded 0; intervention group coded 1.|||0.995|-1.204|0.852
73902337|NCT01933789|147334566|SUPERIORITY||probit regression coefficient|-0.221||||0.418|TWO_SIDED|95.0|-0.923|0.482||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient race and health status and by clinician type and specialty|Control group coded 0; intervention group coded 1.|||0.482|-0.923|0.418
73902338|NCT01933789|147334567|SUPERIORITY||probit regression coefficient|0.175||||0.568|TWO_SIDED|95.0|-0.613|0.962||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.962|-0.613|0.568
73902339|NCT01933789|147334568|SUPERIORITY||probit regression coefficient|0.14||||0.592|TWO_SIDED|95.0|-0.534|0.815||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||0.815|-0.534|0.592
73902340|NCT01933789|147334571|SUPERIORITY||probit regression coefficient|-0.179||||0.705|TWO_SIDED|95.0|-1.398|1.04||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||1.040|-1.398|0.705
73902341|NCT01933789|147334572|SUPERIORITY||probit regression coefficient|0.123||||0.644|TWO_SIDED|95.0|-0.56|0.805||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||0.805|-0.560|0.644
73902342|NCT01933789|147334573|SUPERIORITY||probit regression coefficient|-0.165||||0.908|TWO_SIDED|95.0|-3.833|3.503||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient education and health status and by clinician gender.|Control group coded 0; intervention group coded 1.|||3.503|-3.833|0.908
73902343|NCT01933789|147334574|SUPERIORITY||probit regression coefficient|-0.121||||0.552|TWO_SIDED|95.0|-0.646|0.403||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.403|-0.646|0.552
73902344|NCT01933789|147334575|SUPERIORITY||probit regression coefficient|-0.293||||0.372|TWO_SIDED|95.0|-1.139|0.553||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.553|-1.139|0.372
73902345|NCT01933789|147334576|SUPERIORITY||probit regression coefficient|-0.13||||0.501|TWO_SIDED|95.0|-0.63|0.369||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.369|-0.630|0.501
73902346|NCT01933789|147334577|SUPERIORITY||probit regression coefficient|-0.39||||0.192|TWO_SIDED|95.0|-1.16|0.38||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.380|-1.160|0.192
73902347|NCT01933789|147334578|SUPERIORITY||probit regression coefficient|-0.014||||0.94|TWO_SIDED|95.0|-0.489|0.461||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.461|-0.489|0.940
73902348|NCT01933789|147334579|SUPERIORITY||probit regression coefficient|-0.229||||0.47|TWO_SIDED|95.0|-1.044|0.587||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.587|-1.044|0.470
73902349|NCT01933789|147334580|SUPERIORITY||probit regression coefficient|-0.01||||0.955|TWO_SIDED|95.0|-0.474|0.454||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.454|-0.474|0.955
73902350|NCT01933789|147334581|SUPERIORITY||probit regression coefficient|-0.287||||0.303|TWO_SIDED|95.0|-1.005|0.431||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.431|-1.005|0.303
73902351|NCT02757950|147334582|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.548||||0.1147|TWO_SIDED|95.0|0.259|1.157||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||1.157|0.259|0.1147
73961958|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.242|TWO_SIDED|95.0|-0.045|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 26|||0.180|-0.045|0.242
74084771|NCT01493596|147722956|OTHER|Comparison of event rates across dose groups.|percentage|14.3|||||TWO_SIDED||||||||There were a total of 5 non-serious adverse events for an AE rate of 14.3%|Descriptive statistics for evaluation of AEs|Descriptive statistics of adverse events|||
73852197|NCT00281099|147252315|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.21. The one-sided upper confidence bound for the hazard ratio had to be less than 1.21 for the null hypothesis to be rejected. The threshold of 1.21 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month event-free rates.|Hazard Ratio (HR)|1.139||||||96.3|1.139|1.59||There were 167 events by 90 subjects in the VVI 40 arm, compared to 188 events among 104 subjects in the MVP arm.|Andersen-Gill Model|An Andersen-Gill model was used to account for multiple primary endpoints per subject.|4 interim analyses were performed \& the O'Brien-Fleming alpha-spending function required a 96.3% confidence interval.|"This is a multiple events survival analysis, with time to first primary endpoint, time between successive endpoints, and time from last endpoint to last follow-up visit determined for each subject. The null hypothesis is that the mortality/ heart failure (HF) urgent care/HF hospitalization hazard rate for patients with no Class I pacing indication and MVP is greater than that of similar patients with VVI 40."||1.590|1.139|
73852198|NCT00281099|147252316|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.241. The one-sided upper confidence bound for the hazard ratio had to be less than 1.241 for the null hypothesis to be rejected. The threshold of 1.241 was derived by using a non-inferiority threshold of a 5 percentage point difference in 24 month HF event-free rates.|Hazard Ratio (HR)|1.029||||||95.0|1.029|1.381|||Andersen-Gill Model|An Andersen-Gill model was utilized to account for multiple HF events per subject.||This is a multiple events survival analysis, and so the time from randomization to first HF event, time between successive HF events, and time from last HF event to last follow-up visit was determined for each subject. Since non-inferiority analysis is intended to prove that one therapy is equivalent or superior to another therapy, the null hypothesis being tested is that the worsening HF hazard rate for patients with MVP programming is greater than that of patients with VVI 40 programming.||1.381|1.029|
73852199|NCT00281099|147252317|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interactions between randomization arm and time.|Cumulative Logits Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||A model with covariates for time and randomization arm was fit to test the null hypothesis that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. This analysis combined NYHA IV and Death into one category. The model included interaction terms for time and randomization arm.||||> 0.05
73852200|NCT00281099|147252317|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interaction terms between randomization arm and time.|Cumulative Logit Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||The null hypothesis for this analysis was the same as for the prior analysis: that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. In this analysis, however, death was considered a 5th category in addition to NYHA I-IV. An interaction term for time and randomization arm was also included.||||> 0.05
73852201|NCT00281099|147252318|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Model fit with time and arm as covariates, the interaction between them included. Interaction shown to not be significant and model refit without it.||A linear mixed model was fit for each of the followoing: LVEDD, LVESD, Septal Wall Thickness, and Posterior Wall Thickness; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
73852202|NCT00281099|147252319|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: LV Ejection Fraction and LV Fractional Shortening; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
73852203|NCT00281099|147252320|SUPERIORITY_OR_OTHER|||||||0.0424||95.0||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|The model was fit with time and arm as covariates.||"A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values for left ventricular end diastolic volume (LVEDV) over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."||||0.0424
73852204|NCT00281099|147252320|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Models were fit with time and arm as covariates.||"Similar models were fit for left ventricle (LV) End Systolic Volume and Left Atrial Volume."||||>0.10
73902352|NCT02757950|147334583|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.428||||0.0155|TWO_SIDED|95.0|0.215|0.851||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.851|0.215|0.0155
74084772|NCT04381481|147722957|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
73902353|NCT02757950|147334584|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.254||||0.0127|TWO_SIDED|95.0|0.086|0.746||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.746|0.086|0.0127
73902354|NCT02757950|147334585|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.638||||0.0036|TWO_SIDED|95.0|0.471|0.863||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.863|0.471|0.0036
73902355|NCT02757950|147334586|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|1.342||||0.0931|TWO_SIDED|95.0|0.952|1.89||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||1.890|0.952|0.0931
73902356|NCT01277081|147334622|SUPERIORITY_OR_OTHER||Adjusted Mean difference|0.72|||<|0.0001|TWO_SIDED|95.0|0.58|0.86|||Repeated Measure Analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment|Null Hypothesis considered no difference in treatments being compared for breathing score over the first 15 minutes compared to baseline.||0.86|0.58|<0.0001
73902357|NCT01277081|147334623|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.72|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered no difference in treatments being compared for breathing score over 60 minutes.||0.72|0.44|<0.0001
73902358|NCT01277081|147334624|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.65|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null Hypothesis considered no difference in treatments being compared for cold symptoms score after 60 minutes.||0.65|0.36|<0.0001
73902359|NCT01277081|147334625|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.52|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered two treatments being compared to be equal for cold symptom score after 60 minutes.||0.67|0.38|<0.0001
73902360|NCT02524977|147334633|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
73902361|NCT00930982|147334646|SUPERIORITY_OR_OTHER||Difference in Least square means|-2.368|STANDARD_ERROR_OF_MEAN|2.674|<|0.001||||||p-value should be \< 0.023 (one-sided) for a significant result as an interim analysis was performed. Results based on the no-interaction model which was defined as primary analysis.|ANCOVA|Baseline cfu was covariate, treatment and pooled centers factors. As the p-value for interaction was 0.214, the no-interaction model is appropriate.|Least square mean Ciprofloxacin minus placebo|"Ho: CFU(EOT\|Cipro) - CFU(baseline\|Cipro) \> CFU(EOT\|Placebo) - CFU(baseline\|Placebo) CFU = colony forming units EOT=End of treatment (Day 29) Sample size was based a difference of 1.2 log10 CFU/g between placebo and Ciprofloxacin and a standard deviation of 2 log10 CFU/g"||||< 0.001
73902362|NCT02635646|147334699|OTHER|T test for mean comparisons between independent groups||||||0.844||||||Significant p value less than 0.05|t-test, 2 sided|||||||0.844
73902363|NCT02635646|147334700|OTHER|||||||0.624|||||||t-test, 2 sided|||||||0.624
74084773|NCT04381481|147722958|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||snacks with warning compared to control snack||||<0.001
73902364|NCT02635646|147334701|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73902365|NCT02635646|147334702|OTHER|||||||0.516|||||||t-test, 2 sided|||||||0.516
73902366|NCT02635646|147334703|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73902367|NCT00645788|147334704|SUPERIORITY_OR_OTHER|||||||0.076|||||||ANCOVA|||"Ho: \|Cipro 32.5 mg - matching placebo\|=0 and \|Cipro 48.75 mg - matching placebo\|=0"||||0.076
73902368|NCT00645788|147334706|SUPERIORITY_OR_OTHER|||||||0.068|||||||ANCOVA|||"At visit 7 (End of treatment) Ho: \|Cipro 32.5 - matching placebo\| =0 and~\|Cipro 48.75 - matching placebo\| =0"||||0.068
73902369|NCT02207946|147334742|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.28||0.144|TWO_SIDED|95.0|-1.02|0.16|||ANCOVA|||Least square (LS) means are from analysis of covariance (ANCOVA) with treatment and site included as fixed factors and baseline included as covariate.||0.16|-1.02|0.144
74084774|NCT04381481|147722959|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
74084775|NCT04381481|147722960|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
73902370|NCT02104739|147334833|SUPERIORITY|||||||0.27|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide at baseline and 2 hours after ingestion of meal is compared.||||0.27
73902371|NCT02104739|147334833|SUPERIORITY|||||||0.59|||||||Non-parametric Wilcoxon paired rank sum|||Saxagliptin at baseline and 2 hours after ingestion of meal is compared.||||0.59
73902372|NCT02104739|147334833|SUPERIORITY|||||||0.51|||||||Non-parametric Wilcoxon paired rank sum|||Placebo at baseline and 2 hours after ingestion of meal is compared.||||0.51
73852205|NCT00281099|147252321|SUPERIORITY_OR_OTHER|||||||0.0418||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|The model fit with time and arm as covariates.||A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values of Left Ventricular Sphericity Index over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||0.0418
73852206|NCT00281099|147252322|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: TR Velocity, Mitral Inflow-peak E and Mitral Inflow-peak A; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
73852207|NCT00281099|147252323|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Model fit with time and arm as covariates.||A linear mixed model was fit for Mitral Inflow - Deceleration time; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||0.9490
73852208|NCT00281099|147252324|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models fit with time and arm as covariates.||A linear mixed model was fit for each of the following: Left Atrial Area and Mitral Regurgitation Area; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
73852209|NCT00281099|147252325|SUPERIORITY_OR_OTHER|||||||0.8403||95.0||||The a priori threshold for significance for Arm was 0.05.|Cumulative Logits Model|Because Composite Mitral Regurgitation Score was measured on the ordinal scale, a GEE cumulative logits model was fit.||"A General Estimating Equation (GEE) Cumulative Logits model was fit with Arm, Time, and their interaction as covariates in the model to test the hypothesis that patients with no pacing indication and MVP programming have different Mitral Regurgation over time than similar patients with VVI 40 programming. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."||||0.8403
73852210|NCT00281099|147252326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949||||||95.0|0.949|1.209|||Andersen-Gill model|This model was fit to account for multiple events (i.e. days in which true VT/VF occurred) within subject.|Because of the possible correlation within subject of days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of true VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (values less than one favor MVP) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.||1.209|0.949|
73852211|NCT00281099|147252326|SUPERIORITY_OR_OTHER||Difference in Annualized Rates|-0.015||||||95.0|-0.015|0.033|||Bootstrap Confidence Interval|||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of true VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.||0.033|-0.015|
73902373|NCT02104739|147334833|SUPERIORITY|||||||0.31|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide extended-release (ER) at baseline and 2 hours after ingestion of meal is compared.||||0.31
73902374|NCT02104739|147334835|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.02
73902375|NCT02104739|147334837|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).||||<0.05
73902376|NCT02104739|147334837|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).||||<0.05
73902377|NCT02104739|147334839|SUPERIORITY|||||||0.018|||||||ANOVA|||||||0.018
73902378|NCT02104739|147334841|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).||||<0.05
73902379|NCT02104739|147334841|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).||||<0.05
73902380|NCT02104739|147334843|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
73902381|NCT02104739|147334844|SUPERIORITY||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (3 hours, 6 hours).||||>0.05
73902382|NCT02104739|147334844|SUPERIORITY||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (3 hours, 6 hours).||||>0.05
73852212|NCT00281099|147252326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||||95.0|1.31|1.858|||Andersen-Gill model|This model was fit to account for multiple events (i.e. days in which non-VT/VF detected by device as VT/VF) within subject.|Because of the possible correlation within a subject for days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of inappropriately detected non-VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (MVP in numerator) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.||1.858|1.310|
73852213|NCT00281099|147252326|SUPERIORITY_OR_OTHER||Difference in Annualized Rates|0.017||||||95.0|0.017|0.036|||Bootstrap Confidence Interval|||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of inappropriately detected non-VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.||0.036|0.017|
73852214|NCT00281099|147252327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.7166||95.0|1.22|3.0||The threshold for significance was the one-sided upper confidence bound being less than 1.|Andersen-Gill model|||This analysis compared the hazard rates for clinically important AF (defined as a calendar day with \>20 hour of AT/AF as measured by the device). The null hypothesis was that this hazard rate for patients with MVP was equal to or greater than that of patients with VVI 40. The pre-specified model had Arm as a covariate, and accounted for time to first event and time between successive events per subject.||3.0|1.22|0.7166
73852215|NCT00281099|147252327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-100.0|0.8||The threshold for significance was defined as the upper one-sided confidence bound being less than 0.|Bootstrap Confidence Interval|||This analysis compared the percentage of days with \>20 hours of AT/AF as measured by the device(definition of clinically important AF) between arms. The null hypothesis was that this percentage of days for patients with MVP was equal or greater to that of patients with VVI 40.||0.8|-100|
73852216|NCT00281099|147252327|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||The a priori threshold for statistical significance was 0.05.|Log Rank|A one-sided test was used.||This analysis tested the null hypothesis that the hazard rate for development of persistent AF(defined as 2 consecutive visits presenting with AT/AF, 7 consecutive days of 22 or more hours per day of AT/AF, or \< 7 such days due to a cardioversion) in patients with MVP and no pacing indication was equal to or greater than that of similar patients with VVI 40.||||0.325
73852217|NCT00281099|147252327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.145||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF through 6 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) through 6 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.145|0|
73852218|NCT00281099|147252327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.227||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 6 to 12 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 6 to 12 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.227|0|
73961959|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.082||||0.267|TWO_SIDED|95.0|-0.063|0.228||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 39|||0.228|-0.063|0.267
73852219|NCT00281099|147252327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.261||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 12 to 24 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 12 to 24 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.261|0|
73852220|NCT00281099|147252327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||||95.0|-0.1|0.11||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 24 to 36 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 24 to 36 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.110|-0.1|
73852221|NCT00281099|147252328|SUPERIORITY_OR_OTHER|||||||0.0053||95.0||||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis rejected.|Log Rank|||Physicians recorded at each scheduled and unscheduled follow-up whether the subject had developed a Class I indication since their last visit. The time from randomization to Class I indication development or last visit if censored was determined for each subject. The null hypothesis was that the hazard rate for time to development of a Class I pacing indication among patients with MVP programming was equal to or greater than that of patients with VVI 40 programming.||||0.0053
73852222|NCT00281099|147252330|SUPERIORITY_OR_OTHER|||||||0.9791||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 6 months post-implant for patients with MVP programming and was greater than or equal to that of patients with VVI 40 programming.||||0.9791
74024442|NCT00733902|147600907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-0.70|<0.001
73902383|NCT05772702|147334845|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||t-test, 2 sided|||HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to FU2). Null hypothesis: D1 == FU2||||<0.0005
73902384|NCT05772702|147334846|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||t-test, 2 sided|||HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to D5). Note: D5 HDRS-17 were determined prior to receiving the final treatment on D5. Null hypothesis: D1 == D5||||<0.0005
73902385|NCT05772702|147334848|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||QIDS change score were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
73961960|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083||||0.471|TWO_SIDED|95.0|-0.143|0.309||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 52|||0.309|-0.143|0.471
73961961|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.315|TWO_SIDED|95.0|-0.043|0.132||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 2|||0.132|-0.043|0.315
73852223|NCT00281099|147252330|SUPERIORITY_OR_OTHER|||||||0.8984||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 12 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 12 months post-implant for patients with MVP programming was greater than or equal to that of patients with VVI 40 programming.||||0.8984
73852224|NCT00281099|147252330|SUPERIORITY_OR_OTHER|||||||0.7144||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 24 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 24 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.||||0.7144
73852225|NCT00281099|147252330|SUPERIORITY_OR_OTHER|||||||0.5165||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 36 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 36 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.||||0.5165
73961962|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054||||0.143|TWO_SIDED|95.0|-0.018|0.126||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 4|||0.126|-0.018|0.143
73852226|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.0073||95.0||||The p-value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Physical Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0073
73852227|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.2493||95.0||||No adjustment was made for multiple comparisons, and the a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Stability Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.2493
73852228|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.7728||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Frequency Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.7728
73902386|NCT05772702|147334849|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||ASRM scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 ASRM surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
73961963|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072||||0.111|TWO_SIDED|95.0|-0.017|0.16||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 8|||0.160|-0.017|0.111
73961964|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.012||||0.783|TWO_SIDED|95.0|-0.075|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 12|||0.100|-0.075|0.783
73961965|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.283|TWO_SIDED|95.0|-0.049|0.167||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 18|||0.167|-0.049|0.283
73902387|NCT05772702|147334850|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||SHAPS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 SHAPS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
73902388|NCT05772702|147334851|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 OVERALL scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
73902389|NCT05772702|147334851|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|This subscale did not require sphericity corrections.||DASS-42 DEPRESSION SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
73902390|NCT05772702|147334851|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 ANXIETY SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
73902391|NCT05772702|147334851|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 STRESS SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
73902392|NCT05772702|147334852|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.||||||0.021|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||STAI scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 STAI surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||0.021
73902393|NCT05772702|147334853|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||QIDS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
73902394|NCT05772702|147334854|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||CGI severity scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU2||||<0.0005
73902395|NCT05772702|147334854|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.||||||0.006|||||||t-test, 2 sided|||CGI improvement scores were submitted to a paired t-test to measure difference between the improvement assessment on D5 and the assessment at FU2. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D5 = FU2||||0.006
73902396|NCT01857310|147334898|SUPERIORITY||Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-4.7|2.8|||||Adjusted for infertility treatment stratum and study site|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Live birth will be compared using two sided tests conducted at the 0.05 level."||2.8|-4.7|
73902397|NCT01857310|147334898|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.88|1.09|||||Adjusted for infertility treatment stratum and study site|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Live birth will be compared using two sided tests conducted at the 0.05 level."||1.09|0.88|
73902398|NCT01857310|147334899|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Semen volume will be compared using two sided tests conducted at the 0.05 level."||0.2|-0.2|
73902399|NCT01857310|147334899|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.2|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Semen volume will be compared using two sided tests conducted at the 0.05 level."||0.2|-0.1|
73902400|NCT01857310|147334900|SUPERIORITY||Mean Difference (Final Values)|-4.3|||||TWO_SIDED|95.1|-12.5|3.9|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm concentration represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||3.9|-12.5|
73902401|NCT01857310|147334900|SUPERIORITY||Mean Difference (Final Values)|-5.2|||||TWO_SIDED|95.1|-13.6|3.1|||||Weighted for loss to follow-up and adjusted for fertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm concentration represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||3.1|-13.6|
73902402|NCT01857310|147334901|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.1|-2.5|1.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm motility represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||1.5|-2.5|
73902403|NCT01857310|147334901|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.1|-2.7|1.4|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm motility represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||1.4|-2.7|
73902404|NCT01857310|147334902|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.1|-0.8|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm morphology represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||0.1|-0.8|
73902405|NCT01857310|147334902|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.1|-0.9|0.0|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm morphology represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||0|-0.9|
73902406|NCT01857310|147334903|SUPERIORITY||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|0.5|4.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. DNA fragmentation will be compared using two sided tests conducted at the 0.05 level."||4.4|0.5|
73902407|NCT01857310|147334903|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|0.3|4.3|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. DNA fragmentation will be compared using two sided tests conducted at the 0.05 level."||4.3|0.3|
73902408|NCT01857310|147334904|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-19.7|22.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Total motile sperm count will be compared using two sided tests conducted at the 0.05 level."||22.5|-19.7|
73902409|NCT01857310|147334904|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-20.9|21.4|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Total motile sperm count will be compared using two sided tests conducted at the 0.05 level."||21.4|-20.9|
73902410|NCT01857310|147334905|SUPERIORITY||Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-4.7|3.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. hCG detected pregnancy will be compared using two sided tests conducted at the 0.05 level."||3.0|-4.7|
73902411|NCT01857310|147334905|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.91|1.09|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. hCG detected pregnancy will be compared using two sided tests conducted at the 0.05 level."||1.09|0.91|
73902412|NCT01857310|147334906|SUPERIORITY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-4.9|2.8|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Clinical intrauterine pregnancy will be compared using two sided tests conducted at the 0.05 level."||2.8|-4.9|
73902413|NCT01857310|147334906|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.89|1.08|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Clinical intrauterine pregnancy will be compared using two sided tests conducted at the 0.05 level."||1.08|0.89|
73902414|NCT01857310|147334907|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.5|0.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Ectopic pregnancy will be compared using two sided tests conducted at the 0.05 level."||0.6|-0.5|
73902415|NCT01857310|147334907|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.37|3.97|||||Adjusted for fertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Ectopic pregnancy will be compared using two sided tests conducted at the 0.05 level."||3.97|0.37|
73902416|NCT01857310|147334908|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-3.7|1.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Early pregnancy loss will be compared using two sided tests conducted at the 0.05 level."||1.5|-3.7|
73902417|NCT01857310|147334908|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.75|1.15|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Early pregnancy loss will be compared using two sided tests conducted at the 0.05 level."||1.15|0.75|
73902418|NCT01857310|147334909|SUPERIORITY||Risk Difference (RD)|-0.3|||||TWO_SIDED|95.0|-1.9|1.3|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preeclampsia/gestational hypertension will be compared using two sided tests conducted at the 0.05 level."||1.3|-1.9|
73902419|NCT01857310|147334909|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.63|1.36|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preeclampsia/gestational hypertension will be compared using two sided tests conducted at the 0.05 level."||1.36|0.63|
73902420|NCT01857310|147334910|SUPERIORITY||Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-1.9|0.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational diabetes will be compared using two sided tests conducted at the 0.05 level."||0.6|-1.9|
73902421|NCT01857310|147334910|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.47|1.27|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational diabetes will be compared using two sided tests conducted at the 0.05 level."||1.27|0.47|
73902422|NCT01857310|147334911|SUPERIORITY||Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-1.4|3.8|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Cesarean delivery will be compared using two sided tests conducted at the 0.05 level."||3.8|-1.4|
73902423|NCT01857310|147334911|SUPERIORITY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.89|1.39|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Cesarean delivery will be compared using two sided tests conducted at the 0.05 level."||1.39|0.89|
73902424|NCT01857310|147334912|SUPERIORITY||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|0.2|3.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preterm delivery will be compared using two sided tests conducted at the 0.05 level."||3.6|0.2|
73902425|NCT01857310|147334912|SUPERIORITY||Risk Ratio (RR)|1.49|||||TWO_SIDED|95.0|1.04|2.16|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preterm delivery will be compared using two sided tests conducted at the 0.05 level."||2.16|1.04|
73902426|NCT01857310|147334913|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-1.5|2.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Small for gestational age will be compared using two sided tests conducted at the 0.05 level."||2.0|-1.5|
73902427|NCT01857310|147334913|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.75|1.49|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Small for gestational age will be compared using two sided tests conducted at the 0.05 level."||1.49|0.75|
73902428|NCT01857310|147334914|SUPERIORITY||Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational age will be compared using two sided tests conducted at the 0.05 level."||0.1|-0.5|
73961966|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138||||0.038|TWO_SIDED|95.0|0.008|0.267||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 26|||0.267|0.008|0.038
73961967|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.048||||0.467|TWO_SIDED|95.0|-0.083|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 39|||0.180|-0.083|0.467
73902429|NCT01857310|147334915|SUPERIORITY||Risk Difference (RD)|-64.7|||||TWO_SIDED|95.0|-156.0|26.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Birth weight will be compared using two sided tests conducted at the 0.05 level."||26.4|-156|
73902430|NCT01857310|147334916|SUPERIORITY||Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Stillbirth will be compared using two sided tests conducted at the 0.05 level."||0.1|-0.6|
73902431|NCT01857310|147334916|SUPERIORITY||Risk Ratio (RR)|0.25|||||TWO_SIDED|95.0|0.03|2.24|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Stillbirth will be compared using two sided tests conducted at the 0.05 level."||2.24|0.03|
73902432|NCT01857310|147334917|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Neonatal mortality will be compared using two sided tests conducted at the 0.05 level."||0.5|-0.3|
73902433|NCT01857310|147334917|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.25|8.95|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Neonatal mortality will be compared using two sided tests conducted at the 0.05 level."||8.95|0.25|
73902434|NCT01857310|147334918|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Major neonatal complications will be compared using two sided tests conducted at the 0.05 level."||0.4|-0.2|
73902435|NCT01857310|147334918|SUPERIORITY||Risk Ratio (RR)|1.99|||||TWO_SIDED|95.0|0.18|21.9|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Major neonatal complications will be compared using two sided tests conducted at the 0.05 level."||21.9|0.18|
73961968|NCT02299375|147460529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042||||0.64|TWO_SIDED|95.0|-0.138|0.222||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 52|||0.222|-0.138|0.640
73902436|NCT01857310|147334919|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.8|1.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Structural malformations will be compared using two sided tests conducted at the 0.05 level."||1.0|-0.8|
73902437|NCT01857310|147334919|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.53|2.21|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Structural malformations will be compared using two sided tests conducted at the 0.05 level."||2.21|0.53|
73902438|NCT01857310|147334920|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Severe maternal morbidity will be compared using two sided tests conducted at the 0.05 level."||1.3|-0.4|
73902439|NCT01857310|147334920|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.68|3.32|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Severe maternal morbidity will be compared using two sided tests conducted at the 0.05 level."||3.32|0.68|
73902440|NCT01857310|147334921|SUPERIORITY||Mean Difference (Final Values)|-2.34|||||TWO_SIDED|95.0|-7.9|3.23||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Fertilization rate will be compared using generalized estimating equations accounting for multiple cycles per couple."||3.23|-7.90|
73902441|NCT01857310|147334922|SUPERIORITY||Mean Difference (Final Values)|-0.11|||||TWO_SIDED|95.0|-0.33|0.11||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of good quality embryos will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.11|-0.33|
74084776|NCT04381481|147722961|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||Beverages with claim compared to control beverage||||<0.01
74084777|NCT04381481|147722962|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
73961969|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.661|TWO_SIDED|95.0|-2.08|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 2|||3.27|-2.08|0.661
74084778|NCT04381481|147722963|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
73961970|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44||||0.074|TWO_SIDED|95.0|-0.24|5.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 6|||5.12|-0.24|0.074
74084779|NCT04381481|147722964|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
73961971|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.52||||0.21|TWO_SIDED|95.0|-1.43|6.46||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 8|||6.46|-1.43|0.210
74084780|NCT04381481|147722965|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
74084781|NCT04381481|147722966|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.01
74084782|NCT04381481|147722967|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.01
74084783|NCT04381481|147722968|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
74084784|NCT04381481|147722969|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
74084785|NCT04381481|147722970|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
73852229|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.3082||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Burden Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.3082
73852230|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.5422||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Total Symptom Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.5422
73852231|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.0851||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Self-Efficacy Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0851
73852232|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.0502||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Quality of Life Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0502
73852233|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.0463||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Social Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0463
73852234|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.0227||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0227
73852235|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.0582||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Clinical Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0582
73852236|NCT00281099|147252331|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Tests for all ten KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|||The 10 KCCQ analyses were repeated comparing changes from baseline to 24 months between arms. Again if a subject died prior to their 24 month visit, a value of 0 was imputed for their 24 month score.||||> 0.15
73852237|NCT00281099|147252331|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Tests for all 10 KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in these analyses.||The 10 KCCQ analyses were repeated comparing changes from baseline to 36 months between arms. Again if a subject died prior to their 36 month visit, a value of 0 was imputed for their 36 month score.||||> 0.15
73852238|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.1399||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 12 months was compared using a two-sided test. If a subject died before their 12 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 12 month score.||||0.1399
73902442|NCT01857310|147334923|SUPERIORITY||Mean Difference (Final Values)|-1.31|||||TWO_SIDED|95.0|-6.66|4.05||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Proportion of good quality embryos on day 5 will be compared using generalized estimating equations accounting for multiple cycles per couple."||4.05|-6.66|
73852239|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.3573||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 24 months was compared using a two-sided test. If a subject died before their 24 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 24 month score.||||0.3573
73852240|NCT00281099|147252331|SUPERIORITY_OR_OTHER|||||||0.5183||95.0||||The a priori threshold for statistical significance was 0.05, with no adjustment made for multiple comparisons.|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in this analysis.||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 36 months was compared using a two-sided test. If a subject died before their 36 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 36 month score.||||0.5183
73852241|NCT00281099|147252332|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.44. The one-sided upper confidence bound for the hazard ratio had to be less than 1.44 for the null hypothesis to be rejected. The threshold of 1.44 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month survival rates.|Hazard Ratio (HR)|1.26||||||95.0|1.26|1.75|||||This was a non-inferiority analysis, and so a one-sided 95% confidence interval was performed comparing the MVP arm to the VVI 40 arm.|The time from randomization to all cause mortality or last follow-up visit was determined for each subject. The null hypothesis was that the mortality hazard rate for patients with MVP programming was greater than that of patients with VVI40 programming.||1.75|1.26|
73852242|NCT00475085|147252334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013||||0.718|TWO_SIDED|95.0|-0.225|0.2||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 2 (palonosetron vs. granisetron)||0.200|-0.225|0.718
73852243|NCT00475085|147252334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195||||0.01|TWO_SIDED|95.0|-0.017|0.407||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 4 (adding dexamethasone)||0.407|-0.017|0.010
73852244|NCT00475085|147252334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.557|TWO_SIDED|95.0|-0.236|0.186||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 3 - Group 4 (aprepitant vs. prochlorperazine)||0.186|-0.236|0.557
73852245|NCT01477710|147252373|SUPERIORITY_OR_OTHER_LEGACY||ANOVA F-value|266.39|||<|0.0001||||||This p-value is for the omnibus F-test of between-treatment differences in tidal volume|ANOVA|The p-value for the omnibus F-test was \<0.0001||Using ANOVA, pairwise comparisons of treatment means were made using a Tukey adjustment for multiple comparisons.||||<0.0001
73852246|NCT01477710|147252373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|314.4|||<|0.0001||95.0|264.7|364.1|||t-test, 2 sided|||||364.1|264.7|<0.0001
73852247|NCT01477710|147252373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|576.6|STANDARD_ERROR_OF_MEAN|25.0|<|0.0001|TWO_SIDED|95.0|526.9|626.3|||t-test, 2 sided|||||626.3|526.9|<0.0001
73852248|NCT01477710|147252373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|262.2|STANDARD_DEVIATION|25.0|<|0.0001|TWO_SIDED|95.0|212.5|312.0|||t-test, 2 sided|||||312.0|212.5|<0.0001
73852249|NCT01129765|147252374|SUPERIORITY_OR_OTHER||Proportion|0.97|||||TWO_SIDED|95.0|0.83|1.0|||Descriptive|||Proportion responding \>=3 on a 5-point likert scale, with exact 95% confidence interval from the binomial distribution.||1.0|0.83|
73852250|NCT01129765|147252375|SUPERIORITY_OR_OTHER||Proportion|0.97|||||TWO_SIDED|95.0|0.83|1.0|||Descriptive|||Descriptive summary of proportion responding \>=3 on 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.||1.0|0.83|
73852251|NCT01129765|147252376|SUPERIORITY_OR_OTHER||Proportion|0.97||||0.0005|TWO_SIDED|95.0|0.83|1.0|||One-sample proportion|||"Null hypothesis: Pr ≤ 0.7 versus HA: Pr \> 0.7; Pr is proportion using device appropriately. Observed rate calculated with exact 95% confidence interval from the binomial distribution. 2-sided p-value from binomial distribution.~With the proposed sample size of 30 subjects, we will reject the primary null hypothesis if at least 27 are observed to use the device properly. We will have 80% power for this to occur provided that the true rate in the population is at least 92%."||1.0|0.83|0.0005
73852252|NCT01129765|147252377|SUPERIORITY_OR_OTHER||Proportion|1.0|||||TWO_SIDED|95.0|0.88|1.0|||Descriptive|||Descriptive summary of proportion responding \>=3 on a 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.||1.0|0.88|
73852253|NCT01129765|147252378|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.12|||Descriptive|||Descriptive summary of proportion observed to have a safety issue, with exact 95% confidnce interval from the binomial distribution.||0.12|0|
73961972|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.933|TWO_SIDED|95.0|-3.4|3.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 12|||3.12|-3.40|0.933
73902443|NCT01857310|147334924|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.11|0.1||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of embryos transferred will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.10|-0.11|
73902444|NCT01857310|147334925|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.23|0.18||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of embryos cryopreserved will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.18|-0.23|
73902445|NCT01857310|147334926|SUPERIORITY||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-45.4|21.2||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Sperm penetration percentage will be compared using generalized estimating equations accounting for multiple cycles per couple."||21.2|-45.4|
73902446|NCT01857310|147334927|SUPERIORITY||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.16|0.03||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 3 will be compared with Poisson regression using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||0.03|-0.16|
73902447|NCT01857310|147334928|SUPERIORITY||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.88|1.61|||||Fewer than 4 cells|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 3 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.61|0.88|
73902448|NCT01857310|147334929|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.77|1.43|||||Fewer than 8 cells|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 5 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.43|0.77|
73902449|NCT01857310|147334930|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.87|1.09|||||Excellent or good morphology|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Embryo morphology on day 3 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.09|0.87|
73902450|NCT01857310|147334931|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.63|1.06|||||Excellent or good morphology|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Embryo morphology on day 5 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.06|0.63|
73902451|NCT01857310|147334932|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||ICSI|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Method of fertilization will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.09|0.80|
73902452|NCT01857310|147334933|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.88|1.21|||||Excellent or good quality|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Quality of embryos transferred will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.21|0.88|
73852254|NCT01129765|147252379|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.12|||Descriptive|||Descriptive summary of proportion found to have injury, with exact 95% confidnce interval from the binomial distribution.||0.12|0|
73852255|NCT01814878|147252471|NON_INFERIORITY_OR_EQUIVALENCE|Study drug treatment group was considered non-inferior to comparator treatment group, if lower limit of the confidence interval was larger than -2.0|Mean Difference (Final Values)|-4.68||||0.1648|TWO_SIDED|95.0|-11.29|1.93||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||Non-inferiority comparison for Tramadol Hydrochloride/Acetaminophen ER to Tramadol HCl/Acetaminophen IR was performed.||1.93|-11.29|0.1648
73852256|NCT01814878|147252472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.4082|TWO_SIDED|95.0|-1.1|0.45||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||0.45|-1.10|0.4082
73852257|NCT01814878|147252472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.172|TWO_SIDED|95.0|-2.68|0.48||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||0.48|-2.68|0.1720
73852258|NCT01814878|147252472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.0589|TWO_SIDED|95.0|-6.09|0.11||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||0.11|-6.09|0.0589
73852259|NCT01814878|147252473|SUPERIORITY_OR_OTHER|||||||0.1542||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||||0.1542
73852260|NCT01814878|147252473|SUPERIORITY_OR_OTHER|||||||0.0714||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||||0.0714
73852261|NCT01814878|147252473|SUPERIORITY_OR_OTHER|||||||0.1147||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||||0.1147
73852262|NCT01814878|147252473|SUPERIORITY_OR_OTHER|||||||0.2209||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||||||0.2209
73852263|NCT01814878|147252474|SUPERIORITY_OR_OTHER|||||||0.1498||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||||0.1498
73852264|NCT01814878|147252474|SUPERIORITY_OR_OTHER|||||||0.0485||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||||0.0485
73852265|NCT01814878|147252474|SUPERIORITY_OR_OTHER|||||||0.0404||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||||0.0404
73852266|NCT01814878|147252474|SUPERIORITY_OR_OTHER|||||||0.121||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||||||0.1210
73852267|NCT01814878|147252475|SUPERIORITY_OR_OTHER|||||||0.4216||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.4216
73852268|NCT01814878|147252476|SUPERIORITY_OR_OTHER|||||||0.1||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.1000
73852269|NCT01814878|147252477|SUPERIORITY_OR_OTHER|||||||0.3255||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.3255
73852270|NCT01814878|147252478|SUPERIORITY_OR_OTHER|||||||0.2848||||||Day 3: P-value was calculated using student's t-test|Student's t-test|||||||0.2848
73852271|NCT03645421|147252481|OTHER||Least squares (LS) mean difference|-42.11|STANDARD_ERROR_OF_MEAN|4.16|<|0.0001|TWO_SIDED|95.0|-50.47|-33.75|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-33.75|-50.47|<0.0001
73852272|NCT03645421|147252481|OTHER||LS mean difference|-33.61|STANDARD_ERROR_OF_MEAN|4.69|<|0.0001|TWO_SIDED|95.0|-43.04|-24.18|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-24.18|-43.04|<0.0001
73852273|NCT03645421|147252481|OTHER||LS mean difference|-40.3|STANDARD_ERROR_OF_MEAN|4.57|<|0.0001|TWO_SIDED|95.0|-49.49|-31.12|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-31.12|-49.49|<0.0001
73852274|NCT03645421|147252482|OTHER||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.89||0.1476|TWO_SIDED|95.0|-3.08|0.47|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||0.47|-3.08|0.1476
73852275|NCT03645421|147252482|OTHER||LS mean difference|-2.53|STANDARD_ERROR_OF_MEAN|0.92||0.008|TWO_SIDED|95.0|-4.37|-0.69|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.69|-4.37|0.0080
73852276|NCT03645421|147252482|OTHER||LS mean difference|-2.52|STANDARD_ERROR_OF_MEAN|0.89||0.0063|TWO_SIDED|95.0|-4.3|-0.74|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.74|-4.30|0.0063
73852277|NCT03645421|147252485|OTHER||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.48|-0.7|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-0.70|-1.48|<0.0001
73852278|NCT03645421|147252485|OTHER||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.49|-0.71|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.71|-1.49|<0.0001
73852279|NCT03645421|147252485|OTHER||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.15|-0.38|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.38|-1.15|0.0002
73852280|NCT03645421|147252486|OTHER||LS mean difference|-56.69|STANDARD_ERROR_OF_MEAN|8.75|<|0.0001|TWO_SIDED|95.0|-74.3|-39.09|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-39.09|-74.30|<0.0001
73852281|NCT03645421|147252486|OTHER||LS mean difference|-60.58|STANDARD_ERROR_OF_MEAN|9.92|<|0.0001|TWO_SIDED|95.0|-80.53|-40.63|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-40.63|-80.53|<0.0001
73852282|NCT03645421|147252486|OTHER||LS mean difference|-55.07|STANDARD_ERROR_OF_MEAN|9.55|<|0.0001|TWO_SIDED|95.0|-74.28|-35.86|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-35.86|-74.28|<0.0001
73852283|NCT03645421|147252487|OTHER||LS mean difference|-0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.094|-0.047|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-0.047|-0.094|<0.0001
73852284|NCT03645421|147252487|OTHER||LS mean difference|-0.053|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.077|-0.03|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.030|-0.077|<0.0001
73902453|NCT01857310|147334934|SUPERIORITY||Risk Ratio (RR)|2.35|||||TWO_SIDED|95.0|0.74|7.43|||||Abnormal|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Chromosomal complement will be compared using generalized estimating equations accounting for multiple cycles per couple."||7.43|0.74|
73902454|NCT04761627|147334936|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric Least Squares (LS) Means Ratio|0.9325|||||TWO_SIDED|90.0|0.8874|0.9799|||||Switching group vs Continued-use group.|The ratio of geometric LS means, and 90% confidence intervals (CIs) were estimated using the analysis of covariance (ANCOVA) model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.||0.9799|0.8874|
73902455|NCT04761627|147334937|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9483|||||TWO_SIDED|90.0|0.8977|1.0018|||||Switching group vs Continued-use group.|The ratio of geometric LS means, and 90% CIs were estimated using the ANCOVA model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.||1.0018|0.8977|
73961973|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.7||||0.091|TWO_SIDED|95.0|-0.43|5.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 18|||5.82|-0.43|0.091
74024443|NCT00775021|147600930|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.2334|STANDARD_ERROR_OF_MEAN|0.1618|||TWO_SIDED|95.0|-0.03501|0.2334|||Mixed Models Analysis||The mean difference is calculated as etafilconA minus nelfilcon A. Analysis is adjusted for lens type, period, lens type by period interaction, gender, lens type by gender interaction as fixed effects, subject nested within site as random effect.|The alternative hypothesis is that etafilcon A contact lenses will have equal to ro higher ratings of overall comfort than nelfilcon A contact lenses.||0.2334|-0.03501|
73961974|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.69||||0.018|TWO_SIDED|95.0|0.82|8.56||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 26|||8.56|0.82|0.018
73961975|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3||||0.103|TWO_SIDED|95.0|-0.69|7.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 39|||7.29|-0.69|0.103
73961976|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.16||||0.448|TWO_SIDED|95.0|-3.5|7.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 52|||7.82|-3.50|0.448
73961977|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75||||0.089|TWO_SIDED|95.0|-0.27|3.77||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 2|||3.77|-0.27|0.089
73961978|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.76||||0.095|TWO_SIDED|95.0|-0.31|3.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 4|||3.84|-0.31|0.095
73961979|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.19||||0.073|TWO_SIDED|95.0|-0.2|4.58||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 8|||4.58|-0.20|0.073
74084786|NCT04381481|147722971|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
73961980|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.853|TWO_SIDED|95.0|-2.08|2.51||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 12|||2.51|-2.08|0.853
73961981|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37||||0.334|TWO_SIDED|95.0|-1.43|4.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 18|||4.17|-1.43|0.334
73961982|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.33||||0.017|TWO_SIDED|95.0|0.61|6.05||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 26|||6.05|0.61|0.017
73961983|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.13||||0.077|TWO_SIDED|95.0|-0.34|6.59||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 39|||6.59|-0.34|0.077
74024444|NCT00775021|147600931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.07768|||TWO_SIDED|98.7|-0.108|0.06501|||Mixed Models Analysis||Mean difference calculated etafilcon A minus nelfilcon A. Analysis adjusted for lens type, period, lens by period interaction, gender, lens by gender interaction as fixed effects, subject nested within site and eye within subject as random effect.|The alternative hypothesis is that eyes that wore etafilcon A contact lenses will have less inferior region corneal staining than eyes that wore nelfilcon A contact lenses.||0.06501|-0.1080|
74084787|NCT04381481|147722972|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
73961984|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.34||||0.355|TWO_SIDED|95.0|-2.7|7.38||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 52|||7.38|-2.70|0.355
73961985|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.82||||0.044|TWO_SIDED|95.0|0.08|5.55||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 2|||5.55|0.08|0.044
73961986|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.87||||0.032|TWO_SIDED|95.0|0.25|5.49||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 4|||5.49|0.25|0.032
74084788|NCT04381481|147722973|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
74084789|NCT04381481|147722974|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
74024445|NCT00775021|147600932|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.4001|STANDARD_ERROR_OF_MEAN|0.1799|||TWO_SIDED|98.7|-0.0055|0.4001|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses have equal to or higher comfort ratings at the end of the day than nelfilcon A.||0.4001|-0.0055|
74024446|NCT00775021|147600933|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|-0.1088|STANDARD_ERROR_OF_MEAN|0.1741|||TWO_SIDED|98.7|-0.5016|-0.1088|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses will have equal or higher ratings of initial comfort than nelfilcon A contact lenses.||-0.1088|-0.5016|
73902456|NCT04761627|147334939|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9617|||||TWO_SIDED|90.0|0.8319|1.1119|||||Ctrough,ss at Week 28: Switching group vs Continued-use group|The ratio of Geometric LS means, and 90% CI for Ctrough,ss at week 28 were estimated based on an ANCOVA model adjusted for the actual stratification factors of prior biologic use for psoriasis, baseline body weight group, and geographic region.||1.1119|0.8319|
73902457|NCT04761627|147334939|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9662|||||TWO_SIDED|90.0|0.8879|1.0515|||||Ctrough,ss at Week 40: Switching group vs Continued-use group|The ratio of geometric LS means, and 90% CI for Ctrough,ss at week 40 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.||1.0515|0.8879|
73902458|NCT04761627|147334939|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geomtric LS Means Ratio|0.9806|||||TWO_SIDED|90.0|0.8916|1.0785|||||Ctrough,ss at Week 52: Switching group vs Continued-use group|The ratio of geometric LS means, and 90% CI for Ctrough,ss at week 52 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.||1.0785|0.8916|
73902459|NCT04761627|147334940|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Mean difference|0.07|||||TWO_SIDED|90.0|-2.62|2.77|||||Mean difference in PASI percent improvement from baseline at Week 64: Switching group - Continued-use group|Multiple imputation was applied for the point estimate and CI of the mean difference between the switching and continued-use groups. Missing PASI scores at the week 64 visit were imputed by MI.||2.77|-2.62|
73902460|NCT04761627|147334941|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Response difference|0.2|||||TWO_SIDED|90.0|-5.7|6.2|||||Response difference in PASI 75 Response at Week 64: Switching group - Continued-use group|Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.||6.2|-5.7|
74024447|NCT00775021|147600934|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.2489|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|98.7|-0.1301|0.2489|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etaflicon A contact lenses have equal to or higher ratings of ease of handling than nelfilcon A contact lenses.||0.2489|-0.1301|
73902461|NCT04761627|147334942|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Response difference|0.2|||||TWO_SIDED|90.0|-7.4|7.8|||||Response difference in PASI 100 Response at Week 64: Switching group - Continued-use group|Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.||7.8|-7.4|
73902462|NCT04761627|147334944|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Risk Difference (RD)|-0.48|||||TWO_SIDED|90.0|-4.17|3.1|||||Switching group - continued-use group|Risk difference for any EOI: risk difference and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.||3.10|-4.17|
73902463|NCT01634178|147334959|OTHER|Food was considered to have no effect on the PK of apremilast if the 90% confidence interval (CI) of the geometric least squares (LS) mean ratios for AUC0-t and Cmax were completely contained within the range of 80% to 125%.|Ratio of Geometric Least Squares Means|98.3|||||TWO_SIDED|90.0|90.7|106.6|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an analysis of variance model (ANOVA) with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||106.6|90.7|
73902464|NCT01634178|147334961|OTHER||Median Difference|0.75||||0.0077|TWO_SIDED|90.0|0.25|1.25|||Wilcoxon signed-rank test||Median difference (Fed - Fasted) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.25|0.25|0.0077
73902465|NCT01634178|147334962|OTHER|Food was considered to have no effect on the PK of apremilast if the 90% CI of the geometric LS mean ratios for AUC0-t and Cmax were completely contained within the range of 80% to 125%.|Ratio of Geometric LS Means|112.4|||||TWO_SIDED|90.0|109.3|115.6|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an analysis of variance model (ANOVA) with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||115.6|109.3|
74024448|NCT03464045|147600938|OTHER||Hazard Ratio (HR)|0.8||||0.122|TWO_SIDED|95.0|0.61|1.06|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.06|0.61|0.122
73961987|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.75||||0.025|TWO_SIDED|95.0|0.49|7.01||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 8|||7.01|0.49|0.025
73902466|NCT01634178|147334963|OTHER||Ratio of Geometric Least Squares Means|112.0|||||TWO_SIDED|90.0|108.9|115.1|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an ANOVA with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||115.1|108.9|
73902467|NCT05867342|147334967|OTHER|||||||0.77||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.77
73902468|NCT05867342|147334968|OTHER|||||||0.002||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.002
73902469|NCT05867342|147334969|OTHER|||||||0.126||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.126
73902470|NCT05867342|147334971|OTHER|||||||0.213||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.213
73961988|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.785|TWO_SIDED|95.0|-2.5|3.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 12|||3.29|-2.50|0.785
73961989|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.34||||0.052|TWO_SIDED|95.0|-0.03|6.7||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 18|||6.70|-0.03|0.052
73961990|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.53||||0.041|TWO_SIDED|95.0|0.14|6.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 26|||6.92|0.14|0.041
73961991|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.19||||0.043|TWO_SIDED|95.0|0.13|8.25||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 39|||8.25|0.13|0.043
73902471|NCT05867342|147334972|OTHER|||||||0.418||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.418
73902472|NCT05867342|147334973|OTHER|||||||0.756||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.756
73902473|NCT03160859|147335054|SUPERIORITY|||||||0.62|||||||Chi-squared|||Chi Square||||0.62
73902474|NCT02522871|147335071|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.132|||<|0.0001|ONE_SIDED|95.0||-0.049|||one-sided Farrington and Manning|||||-0.049||<0.0001
73902475|NCT02522871|147335071|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.145|||<|0.0001|ONE_SIDED|95.0||-0.062|||one-sided Farrington and Manning|||||-0.062||<0.0001
73902476|NCT02522871|147335072|NON_INFERIORITY|non-inferiority margin of 1.0|Mean Difference (Final Values)|-0.03|||<|0.0001|TWO_SIDED|95.0|-0.084|0.025|||t-test, 1 sided|||||0.025|-0.084|<0.0001
73902477|NCT02522871|147335073|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|0.0||||0.0004|ONE_SIDED|95.0||0.036|||one-sided Farrington and Manning|||||0.036||0.0004
73902478|NCT02522871|147335073|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|0.0||||0.0004|ONE_SIDED|95.0||0.036|||one-sided Farrington and Manning|||||0.036||0.0004
73902479|NCT02522871|147335074|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.001||||0.0006|ONE_SIDED|95.0||0.038|||one-sided Farrington and Manning|||||0.038||0.0006
73902480|NCT02522871|147335074|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.001||||0.0006|ONE_SIDED|95.0||0.038|||one-sided Farrington and Manning|||||0.038||0.0006
73902481|NCT03149848|147335133|OTHER||Ratio|0.786|||||TWO_SIDED|90.0|0.743|0.831||||||||0.831|0.743|
73902482|NCT03149848|147335134|OTHER||Ratio|0.825|||||TWO_SIDED|90.0|0.761|0.895||||||||0.895|0.761|
73902483|NCT03149848|147335135|OTHER||Ratio|0.738|||||TWO_SIDED|90.0|0.702|0.776||||||||0.776|0.702|
73902484|NCT03149848|147335138|OTHER||Ratio|1.272|||||TWO_SIDED|90.0|1.204|1.345||||||||1.345|1.204|
73902485|NCT01244490|147335156|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-8.9|||<|0.001|TWO_SIDED|95.0|-11.9|-5.8|||ANCOVA|||||-5.8|-11.9|<0.001
73902486|NCT01244490|147335156|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-3.8||||0.017|TWO_SIDED|95.0|-6.8|-0.7|||ANCOVA|||||-0.7|-6.8|0.017
73902487|NCT01244490|147335157|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage Improvement|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.4|||Cochran-Mantel-Haenszel|||||36.4|11.1|<0.001
73902488|NCT01244490|147335157|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage Improvement|12.1||||0.024|TWO_SIDED|95.0|-0.9|25.1|||Cochran-Mantel-Haenszel|||||25.1|-0.9|0.024
73902489|NCT01244490|147335158|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.217||||0.003|TWO_SIDED|95.0|-0.358|-0.076|||ANCOVA|||||-0.076|-0.358|0.003
73902490|NCT01244490|147335158|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.162||||0.026|TWO_SIDED|95.0|-0.305|-0.019|||ANCOVA|||||-0.019|-0.305|0.026
73902491|NCT01244490|147335159|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.209||||0.006|TWO_SIDED|95.0|-0.358|-0.059|||ANCOVA|||||-0.059|-0.358|0.006
73902492|NCT01244490|147335159|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.09||||0.242|TWO_SIDED|95.0|-0.241|0.061|||ANCOVA|||||0.061|-0.241|0.242
73902493|NCT01244490|147335160|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||||<0.001
73961992|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.67||||0.562|TWO_SIDED|95.0|-6.58|11.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 52|||11.92|-6.58|0.562
74084790|NCT04381481|147722975|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
73961993|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.746|TWO_SIDED|95.0|-1.09|1.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 2|||1.52|-1.09|0.746
73902494|NCT01244490|147335160|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||||0.196
73902495|NCT01244490|147335162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.165||||0.001|TWO_SIDED|95.0|-0.266|-0.064||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.064|-0.266|0.001
73902496|NCT01244490|147335162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.104||||0.048|TWO_SIDED|95.0|-0.207|-0.001||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.001|-0.207|0.048
73902497|NCT01244490|147335163|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.211||||0.043|TWO_SIDED|95.0|-0.416|-0.007||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.007|-0.416|0.043
73902498|NCT01244490|147335163|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.125||||0.231|TWO_SIDED|95.0|-0.331|0.08||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.080|-0.331|0.231
73961994|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.878|TWO_SIDED|95.0|-1.53|1.79||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 4|||1.79|-1.53|0.878
73961995|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35||||0.644|TWO_SIDED|95.0|-1.15|1.85||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 8|||1.85|-1.15|0.644
73961996|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.715|TWO_SIDED|95.0|-1.86|1.28||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 12|||1.28|-1.86|0.715
74084791|NCT04381481|147722976|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
73902499|NCT01244490|147335164|SUPERIORITY_OR_OTHER_LEGACY||Diiference in Least Squares Mean|-0.229|||<|0.001|TWO_SIDED|95.0|-0.364|-0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.094|-0.364|<0.001
73902500|NCT01244490|147335164|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.181||||0.009|TWO_SIDED|95.0|-0.317|-0.045||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.045|-0.317|0.009
73902501|NCT01244490|147335165|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.094||||0.096|TWO_SIDED|95.0|-0.204|0.017||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.017|-0.204|0.096
73902502|NCT01244490|147335165|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.067||||0.242|TWO_SIDED|95.0|-0.18|0.046||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.046|-0.180|0.242
73902503|NCT01244490|147335166|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.049||||0.5|TWO_SIDED|95.0|-0.191|0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.094|-0.191|0.500
73902504|NCT01244490|147335166|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.078||||0.288|TWO_SIDED|95.0|-0.222|0.066||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.066|-0.222|0.288
73902505|NCT01244490|147335167|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.233||||0.001|TWO_SIDED|95.0|-0.374|-0.092||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.092|-0.374|0.001
73902506|NCT01244490|147335167|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.111||||0.124|TWO_SIDED|95.0|-0.253|0.031||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.031|-0.253|0.124
73902507|NCT01244490|147335168|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.056||||0.139|TWO_SIDED|95.0|-0.131|0.018||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.018|-0.131|0.139
73902508|NCT01244490|147335168|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.039||||0.315|TWO_SIDED|95.0|-0.115|0.037||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.037|-0.115|0.315
73902509|NCT00400153|147335174|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.05 liter|Mean Difference (Final Values)|-0.0035|STANDARD_ERROR_OF_MEAN|0.0095||0.7135||95.0|-0.0222|0.0152|||ANCOVA|||||0.0152|-0.0222|0.7135
73902510|NCT00400153|147335175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.028|0.066|||ANCOVA|||||0.066|0.028|< 0.0001
73902511|NCT00400153|147335176|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.05 liters|Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.011||0.1389||95.0|-0.039|0.005|||ANCOVA|||||0.005|-0.039|0.1389
73902512|NCT00400153|147335177|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.01||0.124||95.0|-0.036|0.004|||ANCOVA|||||0.004|-0.036|0.124
73902513|NCT00400153|147335178|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.01||0.4888||95.0|-0.026|0.013|||ANCOVA|||||0.013|-0.026|0.4888
73902514|NCT00400153|147335179|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.014||||0.1433||95.0|-0.033|0.005|||ANCOVA|||||0.005|-0.033|0.1433
73902515|NCT00400153|147335180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.04|0.083|||ANCOVA|||This analysis is purely exploratory.||0.083|0.04|< 0.0001
73961997|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.803|TWO_SIDED|95.0|-1.62|2.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 18|||2.10|-1.62|0.803
74084792|NCT04381481|147722977|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
74084793|NCT04381481|147722978|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
73852285|NCT03645421|147252487|OTHER||LS mean difference|-0.049|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|-0.074|-0.024|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.024|-0.074|0.0002
73852286|NCT02253433|147252534|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.575|TWO_SIDED|95.0|-0.87|2.07|||Mixed Models Analysis|||||2.07|-.87|0.575
73852287|NCT02253433|147252535|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.141|TWO_SIDED|95.0|-0.18|0.68|||Mixed Models Analysis|||||.68|-.18|0.141
73852288|NCT02253433|147252536|SUPERIORITY||Odds Ratio (OR)|0.86||||0.043|TWO_SIDED|95.0|0.47|1.57|||Mixed Models Analysis|ED visits over the previous 12 months were positively skewed (skewness 2.95; kurtosis 14.1); the responses were dichotomized (0 vs. 1 or more).||||1.57|.47|0.043
73852289|NCT00282087|147252556|SUPERIORITY_OR_OTHER||Two year PFS|78.0||||0.15|TWO_SIDED|95.0|67.0|91.0|||Bayesian Posterior Probability|||The primary endpoint is progression-free survival time, with progression defined as a patient having evidence of recurrent LMS on follow-up evaluation and CT scan. Futility monitoring will be based on the accumulating right-censored PFS time data. The monitoring rules will be based on a Bayesian model.||91|67|0.15
73852290|NCT00282087|147252558|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.00269|||||TWO_SIDED||||||Cox Proportional Hazards|||Age correlation with progression-free survival for patients on study treatment.||||
73852291|NCT00282087|147252559|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.02|||||TWO_SIDED||||||Cox Proportional Hazards|||Menopausal status at diagnosis correlation with progression-free survival for patients on study treatment.||||
74024449|NCT03464045|147600938|OTHER||Hazard Ratio (HR)|0.89||||0.417|TWO_SIDED|95.0|0.67|1.18|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.18|0.67|0.417
74084794|NCT04381481|147722979|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
73852292|NCT00282087|147252560|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.101|||||TWO_SIDED||||||Cox Proportional Hazards|||Uterine serosal involvement correlation with progression-free survival for patients on study treatment.||||
73852293|NCT00282087|147252561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.00676|||||TWO_SIDED||||||Cox Proportional Hazards|||Mitotic rate correlation with progression-free survival for patients on study treatment.||||
73852294|NCT00282087|147252562|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.708|||||TWO_SIDED||||||Cox Proportional Hazards|||Estrogen receptor (ER) status correlation with progression-free survival for patients on study treatment.||||
73852295|NCT00282087|147252563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.906|||||TWO_SIDED||||||Cox Proportional Hazards|||Progesterone receptor (PR) status correlation with progression-free survival for patients on study treatment.||||
73852296|NCT00282087|147252564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.207|||||TWO_SIDED||||||Cox Proportional Hazards|||1988 FIGO Stage correlation with progression-free survival for patients on study treatment.||||
73852297|NCT00282087|147252565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.564|||||TWO_SIDED||||||Cox Proportional Hazards|||Estrogen receptor (ER) or progesterone receptor (PR) positive correlation with progression-free survival for patients on study treatment.||||
73852298|NCT03938103|147252581|OTHER|||||||0.101|||||||Mixed Models Analysis|||||||0.101
73852299|NCT03938103|147252582|OTHER|||||||0.383|||||||Mixed Models Analysis|||||||0.383
73852300|NCT01147250|147252595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \<1.3.|Hazard Ratio (HR)|1.017|||||TWO_SIDED|95.0|0.886|1.168|||||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% confidence interval (CI).||1.168|0.886|
73852301|NCT01147250|147252595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017||||0.8542|TWO_SIDED|95.0|0.886|1.168|||Log Rank||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% CI. Superiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \<1.0.||1.168|0.886|0.8542
73852302|NCT03985943|147252602|OTHER||Strata-adjusted percentage difference|11.5||||0.0003|TWO_SIDED|97.5|4.7|18.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||18.3|4.7|0.0003
73852303|NCT03985943|147252603|OTHER||Strata-adjusted percentage difference|14.3||||0.0002|TWO_SIDED|97.5|6.1|22.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.5|6.1|0.0002
73902516|NCT00400153|147335181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.024|0.065|||ANCOVA|||This analysis is purely exploratory.||0.065|0.024|< 0.0001
74084795|NCT04381481|147722980|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
74084796|NCT04381481|147722981|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
74084797|NCT04381481|147722982|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
73852304|NCT03985943|147252604|OTHER||Strata-adjusted percentage difference|14.9|||<|0.0001|TWO_SIDED|97.5|7.8|22.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.0|7.8|<0.0001
73852305|NCT03985943|147252605|OTHER||Strata-adjusted percentage difference|18.1|||<|0.0001|TWO_SIDED|97.5|9.6|26.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.6|9.6|<0.0001
73852306|NCT03985943|147252606|OTHER||Strata-adjusted percentage difference|24.9|||<|0.0001|TWO_SIDED|97.5|18.4|31.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||31.5|18.4|<0.0001
73852307|NCT03985943|147252606|OTHER||Strata-adjusted percentage difference|28.1|||<|0.0001|TWO_SIDED|97.5|22.0|34.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption.||34.3|22.0|<0.0001
73852308|NCT03985943|147252607|OTHER||Strata-adjusted percentage difference|27.5|||<|0.0001|TWO_SIDED|97.5|19.4|35.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||35.7|19.4|<0.0001
73852309|NCT03985943|147252607|OTHER||Strata-adjusted percentage difference|32.1|||<|0.0001|TWO_SIDED|97.5|24.4|39.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using MI-MAR assumption.||39.8|24.4|<0.0001
73852310|NCT03985943|147252608|OTHER||Strata-adjusted percentage difference|19.5|||<|0.0001|TWO_SIDED|97.5|13.7|25.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||25.2|13.7|<0.0001
73852311|NCT03985943|147252609|OTHER||Strata-adjusted percentage difference|20.3|||<|0.0001|TWO_SIDED|97.5|13.8|26.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.8|13.8|<0.0001
73852312|NCT03985943|147252610|OTHER||Strata-adjusted percentage difference|17.9|||<|0.0001|TWO_SIDED|97.5|11.3|24.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.5|11.3|<0.0001
73852313|NCT03985943|147252611|OTHER||Strata-adjusted percentage difference|19.7|||<|0.0001|TWO_SIDED|97.5|11.2|28.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||28.2|11.2|<0.0001
73852314|NCT03985943|147252612|OTHER||Strata-adjusted percentage difference|20.9|||<|0.0001|TWO_SIDED|97.5|15.8|26.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26|15.8|<0.0001
73902517|NCT00400153|147335182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.027|0.067|||ANCOVA|||This analysis is purely exploratory.||0.067|0.027|< 0.0001
73902518|NCT00400153|147335183|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.012||0.0258||95.0|0.003|0.049|||ANCOVA|||||0.049|0.003|0.0258
73902519|NCT00400153|147335184|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.011||0.3749||95.0|-0.032|0.012|||ANCOVA|||||0.012|-0.032|0.3749
73852315|NCT03985943|147252613|OTHER||Strata-adjusted percentage difference|21.2|||<|0.0001|TWO_SIDED|97.5|14.8|27.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||27.6|14.8|<0.0001
73852316|NCT03985943|147252614|OTHER||Strata-adjusted percentage difference|12.2|||<|0.0001|TWO_SIDED|97.5|8.2|16.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||16.3|8.2|<0.0001
73852317|NCT03985943|147252615|OTHER||Strata-adjusted percentage difference|9.7|||<|0.0001|TWO_SIDED|97.5|5.2|14.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||14.2|5.2|<0.0001
73852318|NCT03985943|147252616|OTHER||Strata-adjusted percentage difference|14.6|||<|0.0001|TWO_SIDED|97.5|10.6|18.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||18.7|10.6|<0.0001
73852319|NCT03985943|147252617|OTHER||Strata-adjusted percentage difference|16.9|||<|0.0001|TWO_SIDED|97.5|11.5|22.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.3|11.5|<0.0001
73852320|NCT03985943|147252618|OTHER||Strata-adjusted percentage difference|3.4||||0.0064|TWO_SIDED|97.5|1.1|5.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||5.8|1.1|0.0064
73852321|NCT03985943|147252619|OTHER||Strata-adjusted percentage difference|4.3||||0.0177|TWO_SIDED|97.5|0.9|7.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for preceding outcome measure was statistically significant at two-sided 2.5% significance level.||7.7|0.9|0.0177
73852322|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Specificity of lesion shape|0.694|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||Null hypothesis is that there is no difference between the two tests.||||<0.001
73852323|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Lesion homogeneity spec, conservative|0.714|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."||||<0.001
73852324|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Lesion homogeneity spec, agressive|0.785|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."||||<0.001
73852325|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Max. elasticity specificity,conservative|0.657||||0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kiloPascals (kPa) (7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||0.001
73852326|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Max. elasticity specificity, aggressive|0.774|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||<0.001
74024450|NCT03464045|147600938|OTHER||Hazard Ratio (HR)|0.88||||0.376|TWO_SIDED|95.0|0.66|1.17|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.17|0.66|0.376
73852327|NCT00716482|147252648|SUPERIORITY_OR_OTHER||median mean elasticity value specificity|0.626||||0.18|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."||||0.18
73902520|NCT00400153|147335185|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.011||0.3355||95.0|-0.033|0.011|||ANCOVA|||||0.011|-0.033|0.3355
73902521|NCT00400153|147335186|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.0743||95.0|-0.042|0.002|||ANCOVA|||||0.002|-0.042|0.0743
73902522|NCT00400153|147335187|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.011||0.5711||95.0|-0.015|0.028|||ANCOVA|||||0.028|-0.015|0.5711
73852328|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Diameter ratio specificity|0.512||||0.006|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."||||0.006
73852329|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Median elasticity ratio specificity|0.649||||0.006|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."||||0.006
73852330|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Max.color scale specificity,conservative|0.703|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."||||<0.001
73852331|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Max. color scale specificity, aggressive|0.785|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall specificity = 78.5%"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."||||<0.001
73852332|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Lesion shape sensitivity|0.979||||0.48|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image lesion shape.~Null hypothesis is that there is no difference between the two tests."||||0.48
73902523|NCT00400153|147335188|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.011||0.2274||95.0|-0.033|0.008|||ANCOVA|||||0.008|-0.033|0.2274
73902524|NCT00400153|147335189|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.011||0.8065||95.0|-0.018|0.024|||ANCOVA|||||0.024|-0.018|0.8065
73902525|NCT00400153|147335190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.043|0.087|||ANCOVA|||This analysis is purely exploratory.||0.087|0.043|< 0.0001
74084798|NCT04381481|147722983|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
73902526|NCT00400153|147335191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.044|0.087|||ANCOVA|||This analysis is purely exploratory.||0.087|0.044|< 0.0001
73902527|NCT00400153|147335192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.04|0.081|||ANCOVA|||This analysis is purely exploratory.||0.081|0.04|< 0.0001
73902528|NCT00400153|147335193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.047|0.089|||ANCOVA|||This analysis is purely exploratory.||0.089|0.047|< 0.0001
73902529|NCT00400153|147335206|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.021||0.417||95.0|-0.058|0.024|||ANCOVA|||||0.024|-0.058|0.417
73902530|NCT00400153|147335207|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02||0.3505||95.0|-0.059|0.021|||ANCOVA|||||0.021|-0.059|0.3505
73902531|NCT00400153|147335208|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02||0.3499||95.0|-0.058|0.021|||ANCOVA|||||0.021|-0.058|0.3499
73902532|NCT00400153|147335209|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.02||0.8288||95.0|-0.044|0.035|||ANCOVA|||||0.035|-0.044|0.8288
74024451|NCT03464045|147600939|OTHER||Hazard Ratio (HR)|0.79||||0.22|TWO_SIDED|95.0|0.55|1.15|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.15|0.55|0.220
73902533|NCT00400153|147335210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.069|0.154|||ANCOVA|||This analysis is purely exploratory.||0.154|0.069|< 0.0001
73902534|NCT00400153|147335211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.049|0.132|||ANCOVA|||This analysis is purely exploratory.||0.132|0.049|< 0.0001
73902535|NCT00400153|147335212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.056|0.138|||ANCOVA|||This analysis is purely exploratory.||0.138|0.056|< 0.0001
73902536|NCT00400153|147335213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.054|0.135|||ANCOVA|||This analysis is purely exploratory.||0.135|0.054|< 0.0001
73902537|NCT00400153|147335214|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.024||0.0688||95.0|-0.003|0.09|||ANCOVA|||||0.09|-0.003|0.0688
74024452|NCT03464045|147600939|OTHER||Hazard Ratio (HR)|0.91||||0.628|TWO_SIDED|95.0|0.63|1.32|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.32|0.63|0.628
73902538|NCT00400153|147335215|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.023||0.3895||95.0|-0.064|0.025|||ANCOVA|||||0.025|-0.064|0.3895
73902539|NCT00400153|147335216|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.022||0.959||95.0|-0.045|0.042|||ANCOVA|||||0.042|-0.045|0.959
73902540|NCT00400153|147335217|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.023||0.7652||95.0|-0.053|0.039|||ANCOVA|||||0.039|-0.053|0.7652
73902541|NCT00400153|147335218|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.023||0.6244||95.0|-0.057|0.034|||ANCOVA|||||0.034|-0.057|0.6244
73902542|NCT00400153|147335219|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.023||0.873||95.0|-0.041|0.049|||ANCOVA|||||0.049|-0.041|0.873
73902543|NCT00400153|147335220|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.023||0.5294||95.0|-0.06|0.031|||ANCOVA|||||0.031|-0.06|0.5294
73902544|NCT00400153|147335221|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.023||0.563||95.0|-0.032|0.058|||ANCOVA|||||0.058|-0.032|0.563
73902545|NCT00400153|147335222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.075|0.167|||ANCOVA|||This analysis is purely exploratory.||0.167|0.075|< 0.0001
73902546|NCT00400153|147335223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.084|0.174|||ANCOVA|||This analysis is purely exploratory.||0.174|0.084|< 0.0001
74084799|NCT04381481|147722984|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
74084800|NCT04784637|147722986|SUPERIORITY|||||||0.064|||||||t-test, 2 sided|||||||0.064
73902547|NCT00400153|147335224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.072|0.163|||ANCOVA|||This analysis is purely exploratory.||0.163|0.072|< 0.0001
73902548|NCT00400153|147335225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.081|0.171|||ANCOVA|||This analysis is purely exploratory.||0.171|0.081|< 0.0001
73902549|NCT00400153|147335230|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.00045|STANDARD_ERROR_OF_MEAN|0.06396||0.9943||95.0|-0.1259|0.125|||ANCOVA|||||0.125|-0.1259|0.9943
73902550|NCT00400153|147335230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01995|STANDARD_ERROR_OF_MEAN|0.06441||0.7569|TWO_SIDED|95.0|-0.1463|0.1064|||ANCOVA|||This analysis is purely exploratory.||0.1064|-0.1463|0.7569
73902551|NCT00400153|147335231|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.1091|STANDARD_ERROR_OF_MEAN|0.1206||0.3659||95.0|-0.1276|0.3458|||ANCOVA|||||0.3458|-0.1276|0.3659
73902552|NCT00400153|147335231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1554|STANDARD_ERROR_OF_MEAN|0.122||0.203|TWO_SIDED|95.0|-0.3947|0.08395|||ANCOVA|||This analysis is purely exploratory.||0.08395|-0.3947|0.203
73902553|NCT00400153|147335232|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.007734|STANDARD_ERROR_OF_MEAN|0.03199||0.809||95.0|-0.05503|0.0705|||ANCOVA|||||0.0705|-0.05503|0.809
73902554|NCT00400153|147335232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06501|STANDARD_ERROR_OF_MEAN|0.03225||0.044|TWO_SIDED|95.0|0.001746|0.1283|||ANCOVA|||This analysis is purely exploratory.||0.1283|0.001746|0.044
73902555|NCT00400153|147335233|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.0129|STANDARD_ERROR_OF_MEAN|0.03002||0.6674||95.0|-0.04598|0.07179|||ANCOVA|||||0.07179|-0.04598|0.6674
74084801|NCT04784637|147722986|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
74084802|NCT04784637|147722987|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74084803|NCT04784637|147722987|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
74084804|NCT02416934|147722989|SUPERIORITY||Mean Difference (Final Values)|-1.5392|STANDARD_ERROR_OF_MEAN|0.7176||0.036|TWO_SIDED|95.0|-2.9761|-0.1022|||t-test, 2 sided|||Comparing DSQ between Dexamethasone and Saline at Day 1 post-op||-.1022|-2.9761|0.036
73852333|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Lesion homogeneity sens, conservative|0.969||||0.74|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."||||0.74
73852334|NCT00716482|147252648|SUPERIORITY_OR_OTHER||elasticity homogeneity,aggressive,sensit|0.962||||0.37|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."||||0.37
73852335|NCT00716482|147252648|SUPERIORITY_OR_OTHER||elasticity homegeneity,conservative,sens|0.99||||0.025|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall sensitivity = 99.0%"|McNemar|||"Elastography image sensitivity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||0.025
73852336|NCT00716482|147252648|SUPERIORITY_OR_OTHER||max. elasticity sensitivity,aggressive|0.972|||>|0.99|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||>0.99
73852337|NCT00716482|147252648|SUPERIORITY_OR_OTHER||median mean elasticity value sensitivity|0.986||||0.046|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."||||0.046
73852338|NCT00716482|147252648|SUPERIORITY_OR_OTHER||diameter ratio sensitivity|0.99||||0.025|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."||||0.025
73852339|NCT00716482|147252648|SUPERIORITY_OR_OTHER||median elasticity ratio sensitivity|0.983||||0.083|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."||||0.083
73852340|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Max.color scale sensitivity,conservative|0.997||||0.008|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."||||0.008
74084805|NCT02416934|147722989|SUPERIORITY||Mean Difference (Final Values)|-0.604|STANDARD_ERROR_OF_MEAN|0.2543|<|0.05|TWO_SIDED|95.0|-1.1151|-0.093|||t-test, 2 sided|||Comparing Bazaz between Dexamethasone and Saline at 6 months post-op||-.0930|-1.1151|<.05
73902556|NCT00400153|147335233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01573|STANDARD_ERROR_OF_MEAN|0.03033||0.604|TWO_SIDED|95.0|-0.04376|0.07523|||ANCOVA|||This analysis is purely exploratory.||0.07523|-0.04376|0.604
73902557|NCT00400153|147335234|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|1.6526|STANDARD_ERROR_OF_MEAN|2.0653||0.4238||95.0|-2.3995|5.7047|||ANCOVA|||||5.7047|-2.3995|0.4238
73902558|NCT00400153|147335234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4376|STANDARD_ERROR_OF_MEAN|2.0874||0.2431|TWO_SIDED|95.0|-1.6578|6.533|||ANCOVA|||This analysis is purely exploratory.||6.533|-1.6578|0.2431
73902559|NCT00400153|147335235|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.056||0.173||95.0|-0.034|0.187|||ANCOVA|||||0.187|-0.034|0.173
74084806|NCT02416934|147722990|SUPERIORITY||Mean Difference (Final Values)|1.7874|STANDARD_ERROR_OF_MEAN|3.1273|<|0.05|TWO_SIDED|95.0|-4.5153|8.0902|||t-test, 2 sided|||Comparing the changes in VNDI between Dexamethasone and Saline from baseline to last visit||8.0902|-4.5153|<.05
73902560|NCT00400153|147335235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.056||0.336|TWO_SIDED|95.0|-0.165|0.056|||ANCOVA|||This analysis is purely exploratory.||0.056|-0.165|0.336
73902561|NCT00400153|147335236|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.062||0.924||95.0|-0.115|0.127|||ANCOVA|||||0.127|-0.115|0.924
73902562|NCT00400153|147335236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|STANDARD_ERROR_OF_MEAN|0.062||0.266|TWO_SIDED|95.0|-0.19|0.053|||ANCOVA|||This analysis is purely exploratory.||0.053|-0.19|0.266
74084807|NCT02416934|147722991|SUPERIORITY|||||||0.375||||||Fisher's Exact Test|Fisher Exact|||||||.375
74024453|NCT03464045|147600939|OTHER||Hazard Ratio (HR)|0.91||||0.632|TWO_SIDED|95.0|0.63|1.33|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.33|0.63|0.632
74084808|NCT01992094|147723059|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||TWO_SIDED|95.0|0.9|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H1N1||1.1|0.9|
74084809|NCT01992094|147723059|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||TWO_SIDED|95.0|0.9|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H3N2||1.1|0.9|
73852341|NCT00716482|147252648|SUPERIORITY_OR_OTHER||Max. color scale sensitivity, aggressive|0.986||||0.21|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."||||0.21
73852342|NCT00716482|147252649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|Kruskal-Wallis one-way ANOVA. Kruskal-Wallis was performed once to get p-values for all of the 9 categories at once.||Null hypothesis: no variance of similarity exists between the three groups||||<0.001
73852343|NCT03248531|147252652|OTHER||Mean posterior difference|31.2|STANDARD_DEVIATION|10.1|||TWO_SIDED|95.0|11.0|50.4|||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 95% credible intervals were presented for the bimekizumab (BKZ) vs placebo (PBO) comparison.||50.4|11.0|
73852344|NCT03248531|147252652|OTHER||Mean posterior difference|-2.2|STANDARD_DEVIATION|10.6|||TWO_SIDED|60.0|-11.2|6.6|||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 60% credible intervals were presented for the BKZ vs adalimumab (ADA) comparison.||6.6|-11.2|
73852345|NCT03248531|147252652|OTHER||Pr [Diff>0%] (%)|99.8|||||||||||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.||||
73852346|NCT03248531|147252652|OTHER||Pr[Diff > 0%](%)|42.1|||||||||||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.||||
73852347|NCT04075513|147252694|NON_INFERIORITY|Non-inferiority was based on a relative margin of 10%. Since higher time in range means better outcome, non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference between Toujeo LS mean and 90% of Tresiba LS mean at Week 12 was \> 0.|Least square mean difference|3.16|STANDARD_ERROR_OF_MEAN|1.163||0.0067|TWO_SIDED|95.0|0.88|5.44||Threshold of significance at \<0.05.|ANCOVA||This estimation parameter corresponds to the difference between Toujeo LS mean and 90% of Tresiba LS mean.|Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||5.44|0.88|0.0067
74084810|NCT01992094|147723059|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||TWO_SIDED|95.0|0.8|1.0|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1||1.0|0.8|
73902563|NCT00400153|147335237|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.065||0.139||95.0|-0.031|0.225|||ANCOVA|||||0.225|-0.031|0.139
74084811|NCT01992094|147723059|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||TWO_SIDED|95.0|0.9|1.0|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2||1.0|0.9|
73852348|NCT04075513|147252695|NON_INFERIORITY|Non-inferiority was based on a relative margin of 10%. Since lower CV means better outcome, non-inferiority was demonstrated if the upper bound of the two-sided 95% CI of the difference between Toujeo LS mean and 110% of Tresiba LS mean at Week 12 was \< 0.|Least square mean difference|-5.44|STANDARD_ERROR_OF_MEAN|0.542|<|0.0001|TWO_SIDED|95.0|-6.5|-4.38||Threshold of significance at \<0.05.|ANCOVA||This estimation parameter corresponds to the difference between Toujeo LS mean and 110% of Tresiba LS mean.|A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially only when the primary endpoint demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||-4.38|-6.50|<0.0001
73902564|NCT00400153|147335237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.066||0.788|TWO_SIDED|95.0|-0.111|0.146|||ANCOVA|||This analysis is purely exploratory.||0.146|-0.111|0.788
73902565|NCT00400153|147335242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.398|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
73902566|NCT00400153|147335243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.482|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
73902567|NCT00400153|147335244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.612|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
73902568|NCT00400153|147335245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.508|STANDARD_ERROR_OF_MEAN|0.058|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
73902569|NCT00400153|147335246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.421|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
73902570|NCT00400153|147335247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
73902571|NCT00400153|147335248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
73902572|NCT00400153|147335249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.378|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
73961998|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.184|TWO_SIDED|95.0|-0.63|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 26|||3.27|-0.63|0.184
73961999|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05||||0.102|TWO_SIDED|95.0|-0.42|4.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 39|||4.52|-0.42|0.102
74084812|NCT01992094|147723060|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-0.5|||||TWO_SIDED|95.0|-5.3|4.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain H1N1||4.2|-5.3|
73962000|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.44||||0.383|TWO_SIDED|95.0|-1.85|4.73||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 52|||4.73|-1.85|0.383
74084813|NCT01992094|147723060|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-2.7|||||TWO_SIDED|95.0|-7.2|1.9|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strainH3N2||1.9|-7.2|
74084814|NCT01992094|147723060|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-1.8|||||TWO_SIDED|95.0|-6.2|2.8|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1||2.8|-6.2|
73902573|NCT00400153|147335250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
73902574|NCT00400153|147335251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.464|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
73902575|NCT00971620|147335261|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.7|TWO_SIDED|95.0|-2.0|4.0|||Wilcoxon rank sum test|||||4.00|-2.00|.70
73902576|NCT00971620|147335263|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon rank sum test|||||||.06
73902577|NCT00971620|147335264|SUPERIORITY_OR_OTHER|||||||0.007|||||||WIlcoxon rank sum test|||||||.007
73902578|NCT00971620|147335265|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon rank sum test|||||||0.48
73902579|NCT00971620|147335266|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon rank sum test|||||||.04
73902580|NCT00971620|147335268|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon rank sum test|||||||.07
73902581|NCT01150474|147335286|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
73902582|NCT01150474|147335287|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||t-test, 2 sided|||||||0.75
73902583|NCT01150474|147335288|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||t-test, 2 sided|||||||0.07
73902584|NCT01150474|147335289|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
73902585|NCT01150474|147335290|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
73902586|NCT01150474|147335291|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||0.14
73902587|NCT01150474|147335292|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
73902588|NCT01150474|147335293|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.55
73902589|NCT01150474|147335294|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||||||0.59
73902590|NCT01423604|147335295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.733||||0.0494|TWO_SIDED|95.0|0.506|1.061||One-sided p-value.|Log Rank|||||1.061|0.506|0.0494
73902591|NCT01423604|147335295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.502||||0.0081|TWO_SIDED|95.0|0.281|0.888||One-sided p-value.|Log Rank|||Cox Regression Analysis of Overall Survival: C-reactive protein (CRP) \> 13 μg/ml; Statistical analysis plan (SAP) specified subgroup analysis||0.888|0.281|0.0081
73902592|NCT01423604|147335296|SUPERIORITY_OR_OTHER||Efron approximation of hazard ratio|0.75||||0.134|TWO_SIDED|95.0|0.513|1.094||Two-sided p-value.|Cox proportional hazards model|||||1.094|0.513|0.1340
73902593|NCT01423604|147335298|SUPERIORITY_OR_OTHER|||||||0.0236|||||||Pearson's chi-square test|||||||0.0236
73902594|NCT00424255|147335300|SUPERIORITY_OR_OTHER|||||||0.2251||95.0||||The one-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test|||||||0.2251
74024454|NCT03464045|147600940|OTHER||Hazard Ratio (HR)|0.84||||0.42|TWO_SIDED|95.0|0.54|1.29|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.29|0.54|0.420
73852349|NCT04075513|147252696|SUPERIORITY|Superiority was demonstrated if the lower bound of the two-sided 95% CI of the adjusted difference estimate of Toujeo and Tresiba at Week 12 was \>0.|Least square mean difference|-2.35|STANDARD_ERROR_OF_MEAN|1.225||0.0548|TWO_SIDED|95.0|-4.75|0.05||Threshold of significance at \<0.05.|ANCOVA|||A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially when the primary endpoint and the secondary endpoint of total CV demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||0.05|-4.75|0.0548
74084815|NCT01992094|147723060|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-4.4|||||TWO_SIDED|95.0|-8.9|0.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2||0.2|-8.9|
73852350|NCT01407952|147252715|SUPERIORITY||Odds Ratio (OR)|2.32||||0.002|TWO_SIDED|95.0|1.36|3.97|||Regression, Logistic|||A intent to treat analysis was performed, using multiple imputation methods.||3.97|1.36|0.002
73852351|NCT01407952|147252715|SUPERIORITY||Odds Ratio (OR)|3.97|||<|0.01|TWO_SIDED|95.0|1.99|7.92||Chi-squared test statistic with one degree of freedom=17.37|Chi-squared|||||7.92|1.99|<0.01
73852352|NCT01407952|147252716|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73852353|NCT01407952|147252717|SUPERIORITY|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||||||0.578
73852354|NCT01407952|147252718|SUPERIORITY|||||||0.352|||||||Chi-squared|Chi-squared test statistic with one degree of freedom = 0.865||||||0.352
73852355|NCT01407952|147252719|SUPERIORITY|||||||0.769|||||||Cochran-Armitage Trend Test|||||||0.769
73852356|NCT01407952|147252720|SUPERIORITY|||||||0.641|||||||Chi-squared|Chi-square test statistic with one degree of freedom=0.217||||||0.641
73852357|NCT01407952|147252721|SUPERIORITY|||||||0.003|||||||Chi-squared|chi-square test statistic with one degree of freedom=8.82||||||0.003
73852358|NCT01407952|147252722|SUPERIORITY|||||||0.162|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=1.955||||||0.162
73852359|NCT01407952|147252723|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
73852360|NCT01407952|147252724|SUPERIORITY||||||<|0.01|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=14.743||||||<0.01
73852361|NCT01407952|147252725|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
73852362|NCT00904670|147252746|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-12.46|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-14.75|-10.17|||ANOVA|||Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-10.17|-14.75|<0.0001
73852363|NCT00904670|147252747|SUPERIORITY_OR_OTHER||LS mean difference|-6.32|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-8.53|-4.11|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-4.11|-8.53|<0.0001
73852364|NCT00904670|147252747|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|95.0|-12.04|-7.91|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-7.91|-12.04|<0.0001
73852365|NCT00904670|147252747|SUPERIORITY_OR_OTHER||LS mean difference|-9.33|STANDARD_ERROR_OF_MEAN|1.28|<|0.0001|TWO_SIDED|95.0|-11.92|-6.75|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-6.75|-11.92|<0.0001
73852366|NCT00904670|147252747|SUPERIORITY_OR_OTHER||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|1.11||0.0016|TWO_SIDED|95.0|-6.04|-1.54|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.54|-6.04|0.0016
73852367|NCT00904670|147252747|SUPERIORITY_OR_OTHER||LS mean difference|-4.77|STANDARD_ERROR_OF_MEAN|1.4||0.0016|TWO_SIDED|95.0|-7.61|-1.94|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.94|-7.61|0.0016
73902595|NCT00424255|147335300|SUPERIORITY_OR_OTHER|||||||0.4502||95.0||||The two-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test|||||||0.4502
73902596|NCT00424255|147335300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.85|1.43|||||Hazard Ratios were estimated using a Pike estimator.|||1.43|0.85|
73902597|NCT02581943|147335330|OTHER|||||||0.366|||||||Log Rank|||||||0.366
73902598|NCT02581943|147335331|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.327|||||||Wilcoxon (Mann-Whitney)|test for CD4+FoxP3||||||0.327
73902599|NCT02581943|147335331|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.142|||||||Wilcoxon (Mann-Whitney)|test for MDSC||||||0.142
73902600|NCT02581943|147335331|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.462||||||test for CD4+ICOS+|Wilcoxon (Mann-Whitney)|||||||0.462
73902601|NCT02581943|147335331|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.87||||||test for CD8+ICOS+|Wilcoxon (Mann-Whitney)|||||||0.870
73902602|NCT02581943|147335331|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.414||||||test for Plamacytoid DC|Wilcoxon (Mann-Whitney)|||||||0.414
73902603|NCT02581943|147335331|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.121||||||test for Monocytes|Wilcoxon (Mann-Whitney)|||||||0.121
73902604|NCT02581943|147335331|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.624||||||test for T cells (CD3+)|Wilcoxon (Mann-Whitney)|||||||0.624
73902605|NCT02581943|147335332|OTHER|||||||0.348|||||||Fisher Exact|||||||0.348
73902606|NCT02581943|147335333|OTHER|||||||0.63|||||||Log Rank|||||||0.63
73902607|NCT02581943|147335334|OTHER|||||||0.692|||||||Log Rank|||||||0.692
74024455|NCT03464045|147600940|OTHER||Hazard Ratio (HR)|0.89||||0.606|TWO_SIDED|95.0|0.57|1.38|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.38|0.57|0.606
73902608|NCT02581943|147335335|OTHER|||||||0.345|||||||Fisher Exact|||||||0.345
73902609|NCT02581943|147335336|OTHER|||||||0.917|||||||Kruskal-Wallis|Test for CD8+ICOS||||||0.917
73902610|NCT02581943|147335336|OTHER|||||||0.746|||||||Kruskal-Wallis|test for MDSC||||||0.746
73902611|NCT02581943|147335336|OTHER|||||||0.302||||||test for CD4+ICOS|Kruskal-Wallis|||||||0.302
73902612|NCT02581943|147335336|OTHER|||||||0.13|||||||Kruskal-Wallis|test for CD8+ICOS+||||||0.130
73902613|NCT02581943|147335336|OTHER|||||||0.628||||||test for Plamacytoid DC|Kruskal-Wallis|||||||0.628
73902614|NCT02581943|147335336|OTHER|||||||0.567||||||test for Monocytes|Kruskal-Wallis|||||||0.567
73902615|NCT02581943|147335336|OTHER|||||||0.311||||||test for T cells (CD3+)|Kruskal-Wallis|||||||0.311
73902616|NCT02380690|147335399|SUPERIORITY|ECLIPSE was powered to detect an effect size of 0.45.||||||0.981||||||Statistical significance was set at p\<0.05|Regression, Linear|||||||0.981
73902617|NCT02380690|147335400|SUPERIORITY|||||||0.774|||||||Regression, Linear|||||||0.774
73902618|NCT02380690|147335401|SUPERIORITY|Power was based on primary outcome.||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.546.|Regression, Linear|||||||0.999
73902619|NCT02380690|147335402|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.403.|Regression, Linear|||||||0.999
73902620|NCT02380690|147335403|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.452.|Regression, Linear|||||||0.999
73902621|NCT02380690|147335404|SUPERIORITY|||||||0.98||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.243.|Regression, Linear|||||||0.980
73902622|NCT02380690|147335405|SUPERIORITY|||||||0.864||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.133.|Regression, Linear|||||||0.864
73902623|NCT02380690|147335406|SUPERIORITY|||||||0.78||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.102.|Regression, Linear|||||||0.780
73902624|NCT02380690|147335407|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.536.|Regression, Linear|||||||0.999
73902625|NCT02380690|147335408|SUPERIORITY|||||||0.997||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.340.|Regression, Linear|||||||0.997
73902626|NCT02380690|147335409|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.384.|Regression, Linear|||||||0.999
73902627|NCT02380690|147335410|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.730.|Regression, Linear|||||||0.999
73902628|NCT02380690|147335411|SUPERIORITY|||||||0.914||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.161.|Regression, Linear|||||||0.914
73902629|NCT02380690|147335412|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.930.|Regression, Linear|||||||0.999
73902630|NCT02380690|147335413|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.379.|Regression, Linear|||||||0.999
73902631|NCT02380690|147335414|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.969.|Regression, Linear|||||||0.999
73902632|NCT00829933|147335418|SUPERIORITY_OR_OTHER|||||||0.429|TWO_SIDED||||||Chi-squared|||For the incidence of bleeding events, paired comparison between the DU-176b groups was performed using the χ2 test.||||0.429
73902633|NCT00829933|147335418|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||Chi-squared|||||||0.077
74024456|NCT03464045|147600940|OTHER||Hazard Ratio (HR)|0.89||||0.609|TWO_SIDED|95.0|0.57|1.38|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.38|0.57|0.609
74024457|NCT02371629|147601038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033|STANDARD_ERROR_OF_MEAN|0.0169||0.051|TWO_SIDED|95.0|0.0|0.066|||Mixed model for repeated measure (MMRM)|||||0.066|0.000|0.051
74024458|NCT04898166|147601058|SUPERIORITY|||||||0|||||||Chi-squared|Chi-square value 18.90 and its asymptotic significance .000||||||0.000
74024459|NCT04898166|147601059|SUPERIORITY|||||||0.081|||||||Chi-squared|Chi-square value 7.544 and its asymptotic significance .273||||||0.081
74024460|NCT00004980|147601087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76|STANDARD_ERROR_OF_MEAN|0.514||0.005||95.0|-4.65|-0.86||a priori threshold for statistical significance was .05|t-test, 2 sided|degree of freedom = 48||||-.86|-4.65|.005
74084816|NCT01992094|147723066|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.6|||||TWO_SIDED|95.0|0.6|0.7||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2||0.7|0.6|
73852368|NCT00904670|147252748|SUPERIORITY_OR_OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.38||0.0051|TWO_SIDED|95.0|-1.88|-0.36|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.36|-1.88|0.0051
73852369|NCT00904670|147252748|SUPERIORITY_OR_OTHER||LS mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.23|-0.95|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.95|-2.23|<0.0001
73852370|NCT00904670|147252748|SUPERIORITY_OR_OTHER||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|0.54||0.0001|TWO_SIDED|95.0|-3.37|-1.2|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.20|-3.37|0.0001
73852371|NCT00904670|147252748|SUPERIORITY_OR_OTHER||LS mean difference|-1.49|STANDARD_ERROR_OF_MEAN|0.51||0.0055|TWO_SIDED|95.0|-2.52|-0.47|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.47|-2.52|0.0055
73852372|NCT00904670|147252748|SUPERIORITY_OR_OTHER||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.41||0.1977|TWO_SIDED|95.0|-1.38|0.29|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.29|-1.38|0.1977
73852373|NCT00904670|147252748|SUPERIORITY_OR_OTHER||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.43||0.0491|TWO_SIDED|95.0|-1.76|0.0|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.00|-1.76|0.0491
73902634|NCT00829933|147335418|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.5|||||TWO_SIDED|95.0|-11.2|8.1|||Wilcoxon (Mann-Whitney)|||||8.1|-11.2|
74084817|NCT01992094|147723067|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - % seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-19.4|||||TWO_SIDED|95.0|-23.2|-15.5||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2||-15.5|-23.2|
73852374|NCT00904670|147252749|SUPERIORITY_OR_OTHER||LS mean difference|-1.69|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.36|-1.02|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.02|-2.36|<0.0001
73902635|NCT00829933|147335418|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Chi-squared|||||||0.320
73902636|NCT00829933|147335418|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.4|||||TWO_SIDED|95.0|-7.6|12.3|||Wilcoxon (Mann-Whitney)|||||12.3|-7.6|
73902637|NCT00829933|147335418|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|7.7|||||TWO_SIDED|95.0|-2.7|18.1|||Wilcoxon (Mann-Whitney)|||||18.1|-2.7|
73902638|NCT02338336|147335424|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
74024461|NCT00004980|147601088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|0.327||0.002||95.0|0.507|2.03||a priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 48||null hypothesis is that the groups are the same||2.03|.507|.002
74024462|NCT00004980|147601089|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.949|STANDARD_ERROR_OF_MEAN|0.524||0.001||95.0|-1.45|-0.44||A priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 46||||-.44|-1.45|.001
74024463|NCT00004980|147601090|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||a priori threshold for statistical significance = .05|Chi-squared|||||||.01
73902639|NCT01986933|147335426|SUPERIORITY||Mean Difference (Final Values)|-21.39|STANDARD_ERROR_OF_MEAN|7.02||0.0027|TWO_SIDED|95.0|-35.25|-7.53||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-7.53|-35.25|0.0027
73902640|NCT01986933|147335426|SUPERIORITY||Mean Difference (Final Values)|-41.16|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-55.17|-27.15||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-27.15|-55.17|<0.0001
73902641|NCT01986933|147335426|SUPERIORITY||Mean Difference (Final Values)|-40.39|STANDARD_ERROR_OF_MEAN|6.95|<|0.0001|TWO_SIDED|95.0|-54.11|-26.67||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-26.67|-54.11|<0.0001
73902642|NCT03119701|147335435|SUPERIORITY||Odds Ratio (OR)|1.3||||0.78|TWO_SIDED|95.0|0.21|8.19||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||8.19|0.21|0.78
74024464|NCT03577990|147601092|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|0.125||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
74029776|NCT03151148|147614041|SUPERIORITY||Geometric mean ratio (GMR)|1.247||||0.863|TWO_SIDED|95.0|0.1002|15.5231|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.5231|0.1002|0.863
74084818|NCT01992094|147723068|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.5|||||TWO_SIDED|95.0|0.5|0.5||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1||0.5|0.5|
74084819|NCT01992094|147723069|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-21.7|||||TWO_SIDED|95.0|-25.5|-17.7||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1||-17.7|-25.5|
73902643|NCT03119701|147335436|SUPERIORITY||Odds Ratio (OR)|1.7||||0.57|TWO_SIDED|95.0|0.28|10.52||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||10.52|0.28|0.57
73902644|NCT03119701|147335437|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||0.08
73902645|NCT03119701|147335439|SUPERIORITY||||||>|0.999||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||>0.999
73902646|NCT03119701|147335442|SUPERIORITY|||||||0.362||||||The threshold for statistical significance was p = 0.05.|Mantel Haenszel|Exact Mantel-Haenszel Chi-Square Test||||||0.3620
74084820|NCT01214239|147723072|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.71|-0.28|||ANCOVA|||||-0.28|-0.71|<0.0001
74084821|NCT01214239|147723073|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.383|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001||95.0|-0.527|-0.238|||ANCOVA|||||-0.238|-0.527|<0.0001
74084822|NCT01214239|147723074|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.677|-0.323|||ANCOVA|||||-0.323|-0.677|<0.0001
74084823|NCT01214239|147723075|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.512|STANDARD_ERROR_OF_MEAN|0.098|<|0.0001||95.0|-0.705|-0.318|||ANCOVA|||||-0.318|-0.705|<0.0001
74084824|NCT01214239|147723076|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001||95.0|-0.69|-0.23|||ANCOVA|||||-0.23|-0.69|0.0001
74084825|NCT01214239|147723077|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.2|STANDARD_ERROR_OF_MEAN|3.1||0.0003||95.0|-17.2|-5.2|||ANCOVA|||||-5.2|-17.2|0.0003
74084826|NCT01214239|147723078|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.8|STANDARD_ERROR_OF_MEAN|3.3||0.0086||95.0|-15.4|-2.3|||ANCOVA|||||-2.3|-15.4|0.0086
74084827|NCT01214239|147723079|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.5|STANDARD_ERROR_OF_MEAN|3.8||0.0135||95.0|-17.0|-2.0|||ANCOVA|||||-2.0|-17.0|0.0135
74084828|NCT01214239|147723080|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.6|STANDARD_ERROR_OF_MEAN|3.8||0.0113||95.0|-17.1|-2.2|||ANCOVA|||||-2.2|-17.1|0.0113
73902647|NCT03119701|147335445|SUPERIORITY||||||<|0.0001||||||Day 2, Day 3, Day 4, Day 5, and Day 6.|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||<.0001
73902648|NCT03119701|147335445|SUPERIORITY|||||||0.13||||||Baseline visit|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.13
73962001|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43||||0.607|TWO_SIDED|95.0|-1.2|2.06||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 2|||2.06|-1.20|0.607
73962002|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.348|TWO_SIDED|95.0|-0.74|2.08||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 4|||2.08|-0.74|0.348
73962003|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.826|TWO_SIDED|95.0|-1.32|1.65||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 8|||1.65|-1.32|0.826
73902649|NCT03119701|147335445|SUPERIORITY|||||||0.0035||||||Day 1|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.0035
73902650|NCT03119701|147335445|SUPERIORITY|||||||0.009||||||Day 9|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.009
73962004|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.588|TWO_SIDED|95.0|-2.13|1.21||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 12|||1.21|-2.13|0.588
74024465|NCT03577990|147601093|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|1250.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
74024466|NCT03577990|147601094|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|300.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
74024467|NCT03577990|147601096|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|500.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
73902651|NCT03119701|147335445|SUPERIORITY|||||||0.1||||||Day 13|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.10
73902652|NCT03119701|147335446|SUPERIORITY|||||||0.66||||||The threshold for statistical significance was p = 0.05.|ANOVA|Repeated measures ANOVA||Patients with an observation below the lower limit of quantification (LLOQ) value at baseline for CD73 were set to have the LLOQ value (LLOQ = 4 ng/ml) at baseline for subgroup determination purposes (2-fold increase in CD73 from baseline). Values below the LLOQ were set to LLOQ/2 = 2 ng/mL.||||0.66
73962005|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41||||0.585|TWO_SIDED|95.0|-1.08|1.91||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 18|||1.91|-1.08|0.585
74024468|NCT04996797|147601112|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.0001|TWO_SIDED|95.0|11.8|36.5|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||36.5|11.8|<.0001
74024469|NCT04996797|147601115|SUPERIORITY||Risk Difference (RD)|30.8|||<|0.0001|TWO_SIDED|95.0|17.4|43.2|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||43.2|17.4|<0.0001
73852375|NCT00904670|147252749|SUPERIORITY_OR_OTHER||LS mean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.5|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.82|-3.50|<0.0001
73852376|NCT00904670|147252749|SUPERIORITY_OR_OTHER||LS mean difference|-2.95|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.77|-2.13|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.13|-3.77|<0.0001
73852377|NCT00904670|147252749|SUPERIORITY_OR_OTHER||LS mean difference|-2.49|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.33|-1.66|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.66|-3.33|<0.0001
73852378|NCT00904670|147252749|SUPERIORITY_OR_OTHER||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.4||0.0035|TWO_SIDED|95.0|-2.07|-0.44|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.44|-2.07|0.0035
73902653|NCT03119701|147335447|SUPERIORITY|||||||0.3||||||The threshold for statistical significance was p = 0.05.|ANOVA|Repeated measures ANOVA||Observations of zero were imputed as 1 pg/ml before logarithmic transformation.||||0.3
73902654|NCT04854642|147335491|OTHER||Least square mean difference|71.62|||<|0.0001|TWO_SIDED|90.0|68.13|75.29|||ANOVA|||||75.29|68.13|<0.0001
73902655|NCT04854642|147335492|OTHER||Least square mean difference|90.93||||0.017|TWO_SIDED|90.0|85.3|96.93|||ANOVA|||||96.93|85.30|0.0170
73902656|NCT04854642|147335493|OTHER||Least square mean difference|90.9||||0.0213|TWO_SIDED|90.0|85.04|97.16|||ANOVA|||||97.16|85.04|0.0213
73902657|NCT04854642|147335494|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73902658|NCT00562627|147335509|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
73902659|NCT00562627|147335510|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
73902660|NCT00562627|147335511|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
73902661|NCT01709578|147335514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.711|||<|0.0001|TWO_SIDED|95.0|1.73|4.247||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|A hierarchical testing procedure was used to control type I error rate at 0.05 and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||4.247|1.730|<0.0001
73902662|NCT01709578|147335514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.284|||<|0.0001|TWO_SIDED|95.0|2.108|5.115||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.115|2.108|<0.0001
73902663|NCT01709578|147335515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.202||||0.0007|TWO_SIDED|95.0|-0.318|-0.086||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.086|-0.318|0.0007
73902664|NCT01709578|147335515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.0004|TWO_SIDED|95.0|-0.325|-0.095||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.095|-0.325|0.0004
73902665|NCT01709578|147335516|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.971|||<|0.0001|TWO_SIDED|95.0|-1.283|-0.658||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.658|-1.283|<0.0001
73902666|NCT01709578|147335516|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.444|||<|0.0001|TWO_SIDED|95.0|-1.752|-1.135||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.135|-1.752|<0.0001
73902667|NCT01709578|147335517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.958|||<|0.0001|TWO_SIDED|95.0|1.764|4.959||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.959|1.764|<0.0001
73902668|NCT01709578|147335517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.374|||<|0.0001|TWO_SIDED|95.0|2.045|5.566||Threshold for significance was 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.566|2.045|<0.0001
73902669|NCT01709578|147335518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.607||||0.0002|TWO_SIDED|95.0|1.774|7.332||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.332|1.774|0.0002
73852379|NCT00904670|147252749|SUPERIORITY_OR_OTHER||LS mean difference|-1.43|STANDARD_ERROR_OF_MEAN|0.53||0.0109|TWO_SIDED|95.0|-2.51|-0.35|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.35|-2.51|0.0109
73852380|NCT00904670|147252750|SUPERIORITY_OR_OTHER||LS mean difference|25.61|STANDARD_ERROR_OF_MEAN|4.61|<|0.0001|TWO_SIDED|95.0|16.26|34.96|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||34.96|16.26|<0.0001
73852381|NCT00904670|147252750|SUPERIORITY_OR_OTHER||LS mean difference|37.1|STANDARD_ERROR_OF_MEAN|5.21|<|0.0001|TWO_SIDED|95.0|26.54|47.66|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||47.66|26.54|<0.0001
73852382|NCT00904670|147252750|SUPERIORITY_OR_OTHER||LS mean difference|45.77|STANDARD_ERROR_OF_MEAN|7.35|<|0.0001|TWO_SIDED|95.0|30.89|60.65|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||60.65|30.89|<0.0001
73852383|NCT00904670|147252750|SUPERIORITY_OR_OTHER||LS mean difference|35.46|STANDARD_ERROR_OF_MEAN|6.57|<|0.0001|TWO_SIDED|95.0|22.14|48.78|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||48.78|22.14|<0.0001
73852384|NCT00904670|147252750|SUPERIORITY_OR_OTHER||LS mean difference|14.86|STANDARD_ERROR_OF_MEAN|5.86||0.0155|TWO_SIDED|95.0|3.0|26.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||26.73|3.00|0.0155
73852385|NCT00904670|147252750|SUPERIORITY_OR_OTHER||LS mean difference|20.69|STANDARD_ERROR_OF_MEAN|6.18||0.0019|TWO_SIDED|95.0|8.17|33.22|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||33.22|8.17|0.0019
73852386|NCT00904670|147252752|SUPERIORITY_OR_OTHER||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.52||0.0014|TWO_SIDED|95.0|-2.85|-0.74|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.74|-2.85|0.0014
73852387|NCT00904670|147252752|SUPERIORITY_OR_OTHER||LS mean difference|-2.79|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.76|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.82|-3.76|<0.0001
73852388|NCT00904670|147252752|SUPERIORITY_OR_OTHER||LS mean difference|-3.89|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-5.12|-2.67|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.67|-5.12|<0.0001
73852389|NCT00904670|147252752|SUPERIORITY_OR_OTHER||LS mean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.65||0.0002|TWO_SIDED|95.0|-3.97|-1.33|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.33|-3.97|0.0002
73852390|NCT00904670|147252752|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.45||0.3492|TWO_SIDED|95.0|-1.34|0.49|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.49|-1.34|0.3492
73852391|NCT00904670|147252752|SUPERIORITY_OR_OTHER||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.5||0.0105|TWO_SIDED|95.0|-2.34|-0.33|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.33|-2.34|0.0105
73852392|NCT00904670|147252753|SUPERIORITY_OR_OTHER||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.43|-1.0|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.00|-2.43|<0.0001
73852393|NCT00904670|147252753|SUPERIORITY_OR_OTHER||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.78|-2.1|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.10|-3.78|<0.0001
73852394|NCT00904670|147252753|SUPERIORITY_OR_OTHER||LS mean difference|-3.34|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-4.11|-2.57|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.57|-4.11|<0.0001
73852395|NCT00904670|147252753|SUPERIORITY_OR_OTHER||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.64|-1.76|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.76|-3.64|<0.0001
73852396|NCT00904670|147252753|SUPERIORITY_OR_OTHER||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.41||0.0006|TWO_SIDED|95.0|-2.4|-0.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.73|-2.40|0.0006
73852397|NCT00904670|147252753|SUPERIORITY_OR_OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.4||0.0087|TWO_SIDED|95.0|-1.94|-0.3|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.30|-1.94|0.0087
73852398|NCT00286091|147252754|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0284|TWO_SIDED|95.0|0.73|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|Primary and secondary endpoint analyses were conducted hierarchically. To preserve an overall type I error rate of 0.05, a 0.0488 2-sided test of bone metastasis-free survival was performed. If superiority of denosumab over placebo was established, time to first bone metastasis was tested with a 2-sided significance level of 0.050. If superiority of denosumab over placebo was also established, overall survival time was tested at a 2-sided significance level of 0.050.||0.98|0.73|0.0284
73852399|NCT00286091|147252755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0317|TWO_SIDED|95.0|0.71|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|||0.98|0.71|0.0317
73852400|NCT00286091|147252756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9125|TWO_SIDED|95.0|0.85|1.2|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|||1.20|0.85|0.9125
73852401|NCT04004221|147252757|OTHER||||||<|0.0001|||||||Exact Binomial Test|1-sided p-value was based on binomial exact test of Tislelizumab versus historical rate of 0.1||||||< 0.0001
73852402|NCT02689206|147252787|OTHER||Mean Difference (Final Values)|0.57|||||TWO_SIDED|95.0|-0.31|1.45|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 10 mg arm from Placebo along with 95 percent CI are presented.|||1.45|-0.31|
74024470|NCT04996797|147601116|SUPERIORITY||Risk Difference (RD)|43.8|||<|0.0001|TWO_SIDED|95.0|27.4|56.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||56.9|27.4|<.0001
73852403|NCT02689206|147252787|OTHER||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.4|1.42|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 15 mg arm from Placebo along with 95 percent CI are presented.|||1.42|-0.40|
73852404|NCT02689206|147252787|OTHER||Mean Difference (Final Values)|1.47|||||TWO_SIDED|95.0|0.59|2.35|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 25 mg arm from Placebo along with 95 percent CI are presented.|||2.35|0.59|
73852405|NCT02689206|147252787|OTHER||Mean Difference (Final Values)|1.67|||||TWO_SIDED|95.0|0.77|2.57|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 30 mg arm from Placebo along with 95 percent CI are presented.|||2.57|0.77|
73902670|NCT01709578|147335518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.653||||0.0056|TWO_SIDED|95.0|1.308|5.383||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.383|1.308|0.0056
73902671|NCT01709578|147335519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.622|||<|0.0001|TWO_SIDED|95.0|2.339|9.132||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.132|2.339|<0.0001
73902672|NCT01709578|147335519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.801|||<|0.0001|TWO_SIDED|95.0|2.948|11.413||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11.413|2.948|<0.0001
73902673|NCT01709578|147335520|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.306|||<|0.0001|TWO_SIDED|95.0|-10.444|-4.167||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.167|-10.444|<0.0001
73852406|NCT00595881|147252833|SUPERIORITY_OR_OTHER||Difference in sensitivity|-1.7|||||TWO_SIDED|95.0|-3.4|0.0||"We calculated the differences between the sensitivities and specificities. The difference in sensitivity between the clinical exam alone vs clinical exam + ultrasound was -1.7% (-3.4%, 0%).~The difference in specificity was -2.8% (-9.7%, 4.1%)."|Mixed effects logistic regression|We used the bootstrap method to obtain valid confidence intervals and compare sensitivity and specificity for the 2 tests.|The clinical exam alone was compared to the clinical exam + ultrasound.|See sample size calculations already entered. Null hypothesis is that there is no difference in the sensitivity or specificity of clinical exam alone compared with clinical exam+ultrasound.||0|-3.4|
73852407|NCT00595881|147252833|SUPERIORITY_OR_OTHER||Difference in specificity|-2.8||||||95.0|-9.7|4.1||Statistical significance was defined as a CI surrounding the difference between groups not including 0.||as previously described for sensitivity||as previously described for sensitivity||4.1|-9.7|
73852408|NCT01479764|147252834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.059|||Pearson's Chi-square test|||Sugammadex is the numerator and Neostigmine/Glycopyrrolate is the denominator.||0.059|0.000|<0.0001
73852409|NCT01479764|147252835|SUPERIORITY_OR_OTHER||Estimated Ratio of Geometric Means|0.83||||0.021|TWO_SIDED|95.0|0.71|0.97|||ANCOVA|Adjusted for age, American Society of Anesthesiologists class, Body Mass Index, comorbidity index \& length of surgical procedure||Sugammadex is the numerator and neostigmine/glycopyrrolate is the denominator. Used log-transformed time intervals.||0.97|0.71|0.021
73852410|NCT00260832|147252837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1079|TWO_SIDED|95.0|||||Kaplan-Meier|||The primary treatment comparison was based on two sided long-rank test stratified by age, cytogenetic risk, ECOG performance status||||0.1079
73852411|NCT00260832|147252838|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0011|TWO_SIDED|95.0|1.4|4.78|||Fisher Exact|||||4.78|1.40|0.0011
73852412|NCT01032603|147252839|SUPERIORITY||Difference in percentage of participants|9.0||||0.24|TWO_SIDED|95.0|-6.0|23.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=46%, RR group=37%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||23|-6|0.24
73852413|NCT01032603|147252840|SUPERIORITY||Difference in percentage of participants|8.0||||0.25|TWO_SIDED|95.0|-6.0|21.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=34%, RR group=26%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||21|-6|0.25
73852414|NCT01032603|147252841|SUPERIORITY||Difference in percentage of participants|-7.0||||0.06|TWO_SIDED|95.0|-14.0|0.23|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=3%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||0.23|-14|0.06
73852415|NCT01032603|147252842|SUPERIORITY||Difference in percentage of participants|4.0||||0.36|TWO_SIDED|95.0|-5.0|14.0|||Z test||Proportion of participants meeting criteria by 3 yrs was obtained by KM method. BLR group=14%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||14|-5|0.36
73852416|NCT01032603|147252844|SUPERIORITY|||||||0.44|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year distance control will adjust for baseline distance control).||||0.44
73852417|NCT01032603|147252847|SUPERIORITY|||||||0.64|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year near control will adjust for baseline near control).||||0.64
73852418|NCT01032603|147252850|SUPERIORITY|||||||0.21|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.21
73852419|NCT01032603|147252853|SUPERIORITY|||||||0.38|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.38
73852420|NCT01032603|147252856|SUPERIORITY|||||||0.93|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.93
73852421|NCT01032603|147252859|SUPERIORITY|||||||0.82|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.82
73852422|NCT01032603|147252861|SUPERIORITY|||||||0.3||||||Child 5 to 7 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.30
73852423|NCT01032603|147252861|SUPERIORITY|||||||0.77||||||Child 8 to 13 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.77
73852424|NCT01032603|147252861|SUPERIORITY|||||||0.51||||||Parent Proxy IXTQ|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.51
73852425|NCT01032603|147252861|SUPERIORITY|||||||0.42||||||Parent Psychosocial|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.42
73902674|NCT01709578|147335520|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.727|||<|0.0001|TWO_SIDED|95.0|-12.833|-6.622||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.622|-12.833|<0.0001
74024471|NCT04996797|147601117|SUPERIORITY||Risk Difference (RD)|20.8||||0.0224||95.0|2.1|37.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factor of biologic status.|95% CI is estimated using Newcombe method for risk difference.|||37.9|2.1|0.0224
74024472|NCT04996797|147601118|SUPERIORITY||Risk Difference (RD)|13.1||||0.0223||95.0|1.8|24.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||24.6|1.8|0.0223
73852426|NCT01032603|147252861|SUPERIORITY|||||||0.68||||||Parent Function|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.68
73852427|NCT01032603|147252861|SUPERIORITY|||||||0.64||||||Parent Surgical|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.64
73852428|NCT01032603|147252862|SUPERIORITY||Difference in percentage|5.0|||||TWO_SIDED|95.0|-2.0|13.0||||||"The cumulative proportion of participants with re-operation by 3 years was obtained using the Kaplan-Meier (K-M) method.~A treatment-group difference and a corresponding 95% confidence interval were calculated.~Treatment-group differences were calculated as BLR minus RR."||13|-2|
73852429|NCT01032603|147252863|SUPERIORITY||Difference in percentage of participants|-15.0|||||TWO_SIDED|95.0|-30.0|-0.0003||||||All treatment-group differences were calculated as the BLRc group minus the R\&R group. A treatment-group difference and a corresponding 95% confidence interval were calculated.||-.0003|-30|
73852430|NCT01032603|147252864|SUPERIORITY||Difference in percentage of participants|12.0|||||TWO_SIDED|95.0|-1.0|25.0||||||The proportion of participants with suboptimal surgical outcome at 3 years was compared between treatment groups using Barnard's exact test, and an exact 95% CI on the treatment-group difference was calculated using Farrington-Manning scores.||25|-1|
73852431|NCT01104545|147252885|OTHER||Geometric mean ratio (GMR)|1.0|||||||||||||GMR = Fed/Fasted|||||
73852432|NCT01104545|147252886|OTHER||GMR|0.73|||||||||||||GMR = Fed/fasted|||||
73852433|NCT02993822|147252910|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.324|TWO_SIDED|95.0|0.88|1.49|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.49|0.88|0.324
73852434|NCT02993822|147252910|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.332|TWO_SIDED|95.0|0.88|1.48|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.48|0.88|0.332
73852435|NCT02993822|147252910|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.531|TWO_SIDED|95.0|0.71|1.2|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.20|0.71|0.531
73852436|NCT02993822|147252911|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.482|TWO_SIDED|95.0|0.75|1.15|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.15|0.75|0.482
73852437|NCT02993822|147252911|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.46|TWO_SIDED|95.0|0.75|1.14|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.14|0.75|0.460
73852438|NCT02993822|147252911|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.144|TWO_SIDED|95.0|0.69|1.06|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.06|0.69|0.144
73852439|NCT02993822|147252912|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.992|TWO_SIDED|95.0|0.78|1.27|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.27|0.78|0.992
73902675|NCT01709578|147335521|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.183||||0.0078|TWO_SIDED|95.0|-0.318|-0.048||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.048|-0.318|0.0078
73852440|NCT02993822|147252912|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.387|TWO_SIDED|95.0|0.71|1.14|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.14|0.71|0.387
73852441|NCT02993822|147252912|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.6|TWO_SIDED|95.0|0.74|1.19|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.19|0.74|0.600
73852442|NCT02993822|147252913|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.042|TWO_SIDED|95.0|0.0|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|0.0|0.042
73852443|NCT02993822|147252913|SUPERIORITY||Median Difference (Final Values)|1.1||||0.026|TWO_SIDED|95.0|0.1|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|0.1|0.026
73852444|NCT02993822|147252913|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.003|TWO_SIDED|95.0|0.5|2.4|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.4|0.5|0.003
73852445|NCT02993822|147252914|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.25|TWO_SIDED|95.0|-0.4|1.7|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.7|-0.4|0.250
73852446|NCT02993822|147252914|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.325|TWO_SIDED|95.0|-0.5|1.5|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.5|-0.5|0.325
73962006|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.82||||0.231|TWO_SIDED|95.0|-2.48|10.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 26|||10.12|-2.48|0.231
73962007|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.45||||0.24|TWO_SIDED|95.0|-0.99|3.89||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 39|||3.89|-0.99|0.240
73962008|NCT02299375|147460530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.17||||0.517|TWO_SIDED|95.0|-2.49|4.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 52|||4.84|-2.49|0.517
73962009|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.67||||0.706|TWO_SIDED|95.0|-4.2|2.85||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 12|||2.85|-4.20|0.706
73962010|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.694|TWO_SIDED|95.0|-3.58|5.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 26|||5.36|-3.58|0.694
73962011|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.83||||0.382|TWO_SIDED|95.0|-9.23|3.58||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 39|||3.58|-9.23|0.382
73962012|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.903|TWO_SIDED|95.0|-8.54|7.57||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 52|||7.57|-8.54|0.903
73902676|NCT01709578|147335521|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.242||||0.0004|TWO_SIDED|95.0|-0.376|-0.109||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.109|-0.376|0.0004
73902677|NCT01709578|147335522|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25||||0.0004|TWO_SIDED|95.0|1.45|5.049||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.049|1.450|0.0004
73902678|NCT01709578|147335522|SUPERIORITY_OR_OTHER||LS Mean Difference|4.075|||<|0.0001|TWO_SIDED|95.0|2.305|5.846||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.846|2.305|<0.0001
73902679|NCT01709578|147335523|SUPERIORITY_OR_OTHER||LS Mean Difference|1.515||||0.2026|TWO_SIDED|95.0|-0.818|3.848||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||3.848|-0.818|0.2026
73902680|NCT01709578|147335523|SUPERIORITY_OR_OTHER||LS Mean Difference|2.013||||0.0854|TWO_SIDED|95.0|-0.282|4.309||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.309|-0.282|0.0854
73902681|NCT00902161|147335576|SUPERIORITY_OR_OTHER||Least Squared Mean Treatment Difference|32.0||||0.005|TWO_SIDED|95.0|15.0|49.0||There was only 1 primary hypothesis, so no multiplicity adjustment was required.|A linear mixed effect (LME) model|||The p-value is for testing the null hypothesis that the difference on Rt(65) between the \[MK-0893 1g + Propranolol\] vs. \[PBO + Propranolol\] \>=60 min. If p-value \< 0.05, then the null hypothesis is rejected at the significance level of 0.05, thus supporting the primary hypothesis that the treatment difference is less than 60 minutes.||49|15|0.005
73902682|NCT00988325|147335592|SUPERIORITY_OR_OTHER||Median time to cessation of viral sheddi|119.0|||=|0.166|TWO_SIDED|95.0|113.0|230.0||p-value is for the comparison of the age cohorts (treatment groups)|Wilcoxon (Mann-Whitney)|Wilcoxon Test was used for testing homogeneity of survival curves|Median time was estimated from the Kaplan-Meier curve (unstratified)|||230|113|=0.166
73902683|NCT00988325|147335594|SUPERIORITY_OR_OTHER||Time to Resolution of Fever in Patients|14.5|||=|0.059|TWO_SIDED|95.0|12.0|20.0||The p-value is for the comparison of the age cohorts (not including Total)|Wilcoxon (Mann-Whitney)||Median time was estimated from the Kaplan-Meier curve (unstratified)|||20|12|=0.059
73902684|NCT01314911|147335610|SUPERIORITY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|4.6||0.0097|TWO_SIDED|95.0|-21.4|-3.0||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Oseltamivir arm minus the percent detectable in the Placebo arm.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Oseltamivir arm was better than the placebo arm and that the detectable rate in the Oseltamivir arm was 42.5% compared to 57.5% in the placebo arm (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.||-3.0|-21.4|0.0097
73902685|NCT01314911|147335613|SUPERIORITY|||||||0.0243||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)|||||||0.0243
73962013|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.67||||0.481|TWO_SIDED|95.0|-6.33|2.99||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 12|||2.99|-6.33|0.481
73962014|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.793|TWO_SIDED|95.0|-4.79|6.25||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 26|||6.25|-4.79|0.793
74024473|NCT04996797|147601119|SUPERIORITY||Risk Difference (RD)|28.6||||0.0009||95.0|12.1|42.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||42.9|12.1|0.0009
74024474|NCT04996797|147601120|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.0001||95.0|14.3|39.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||39.6|14.3|<0.0001
73962015|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6||||0.421|TWO_SIDED|95.0|-12.45|5.26||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 39|||5.26|-12.45|0.421
73902686|NCT01314911|147335614|SUPERIORITY|||||||0.41||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.41
73902687|NCT01314911|147335615|SUPERIORITY|||||||0.88||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.88
73902688|NCT01314911|147335616|SUPERIORITY|||||||0.7461||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.7461
73902689|NCT01314911|147335617|SUPERIORITY|||||||0.1501||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.1501
73902690|NCT01314911|147335618|SUPERIORITY|||||||0.3025||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.3025
73902691|NCT01314911|147335619|SUPERIORITY|||||||0.5466||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.5466
73962016|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.98||||0.162|TWO_SIDED|95.0|-19.35|3.4||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 52|||3.40|-19.35|0.162
74024475|NCT04996797|147601121|SUPERIORITY||Risk Difference (RD)|17.9||||||95.0|-2.4|36.4|||||95% CI is estimated using Newcombe method for risk difference.|||36.4|-2.4|
73902692|NCT01314911|147335621|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5311|TWO_SIDED|95.0|-1.4|3.0||P-value was not adjusted for multiple interim analyses.|two-sample binomial exact test|The two-sample binomial exact test was performed in PROC STATXACT.|The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.|||3.0|-1.4|0.5311
73902693|NCT01314911|147335622|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8498|TWO_SIDED|95.0|-3.8|4.7||P-value was not adjusted for multiple interim analyses.|Z test||The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.|This test compared the difference in percentages of participants with at least one complication between two randomized arms.||4.7|-3.8|0.8498
73902694|NCT01314911|147335624|SUPERIORITY||Mean Difference (Final Values)|-13.6||||0.0021|TWO_SIDED|95.0|-22.2|-5.1||P-value was not adjusted for multiple interim analyses.|Z test||||The difference in percents was calculated as the percent with detectable in the Oseltamivir arm minus the percent with detectable in the placebo arm.|-5.1|-22.2|0.0021
73902695|NCT01314911|147335627|SUPERIORITY|||||||0.022||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)|||||||0.022
73962017|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.23||||0.592|TWO_SIDED|95.0|-3.31|5.78||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 12|||5.78|-3.31|0.592
73962018|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03||||0.704|TWO_SIDED|95.0|-4.31|6.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 26|||6.36|-4.31|0.704
73962019|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.41||||0.546|TWO_SIDED|95.0|-10.32|5.5||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 39|||5.50|-10.32|0.546
73962020|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39||||0.35|TWO_SIDED|95.0|-5.06|13.84||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 52|||13.84|-5.06|0.350
73962021|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.411|TWO_SIDED|95.0|-5.75|2.37||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 12|||2.37|-5.75|0.411
73962022|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.896|TWO_SIDED|95.0|-5.67|4.97||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 26|||4.97|-5.67|0.896
73962023|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.21||||0.559|TWO_SIDED|95.0|-9.73|5.3||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 39|||5.30|-9.73|0.559
73902696|NCT03150485|147335677|SUPERIORITY|Superiority was established is the lower limit of the 95% confidence interval was above 50%.|Estimated Proportion|77.27|||||TWO_SIDED|95.0|56.15|90.29|||Agresti-Coull|||The Agresti-Coull method was used to estimate the confidence interval of the binomial proportions of subjects with less than 2 lens modifications.||90.29|56.15|
73962024|NCT02299375|147460537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.809|TWO_SIDED|95.0|-12.19|9.6||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 52|||9.60|-12.19|0.809
73962025|NCT00704184|147460556|SUPERIORITY_OR_OTHER||Adjusted difference in %|69.3|||<|0.001|TWO_SIDED|95.0|40.3|86.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||86.7|40.3|<0.001
73962026|NCT00704184|147460556|SUPERIORITY_OR_OTHER||Adjusted difference in %|73.6|||<|0.001|TWO_SIDED|95.0|46.0|88.6|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||88.6|46.0|<0.001
73962027|NCT00704184|147460556|SUPERIORITY_OR_OTHER||Adjusted difference in %|63.3|||<|0.001|TWO_SIDED|95.0|32.8|82.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||82.7|32.8|<0.001
73962028|NCT00704184|147460556|SUPERIORITY_OR_OTHER||Adjusted difference in %|77.8|||<|0.001|TWO_SIDED|95.0|49.2|91.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3) and stratifies by HCV genotype (1a vs. non-1a).|||91.3|49.2|<0.001
73962029|NCT00704184|147460559|SUPERIORITY_OR_OTHER||Adjusted difference|11.2|||||TWO_SIDED|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.8|-9.7|
73962030|NCT00704184|147460559|SUPERIORITY_OR_OTHER||Adjusted difference|10.8|||||TWO_SIDED|95.0|-7.6|33.2|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.2|-7.6|
73962031|NCT00704184|147460559|SUPERIORITY_OR_OTHER||Adjusted difference|11.2|||||TWO_SIDED|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.8|-9.7|
73962032|NCT00704184|147460559|SUPERIORITY_OR_OTHER||Adjusted difference|5.4|||||TWO_SIDED|95.0|-16.5|28.4|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||28.4|-16.5|
73962033|NCT00704184|147460560|SUPERIORITY_OR_OTHER||Adjusted difference|16.9|||||TWO_SIDED|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||40.2|-4.0|
74024476|NCT04996797|147601122|SUPERIORITY||Risk Difference (RD)|22.8||||||95.0|0.4|42.2|||||95% CI is estimated using Newcombe method for risk difference.|||42.2|0.4|
73962034|NCT00704184|147460560|SUPERIORITY_OR_OTHER||Adjusted difference|16.2|||||TWO_SIDED|95.0|-2.2|39.5|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||39.5|-2.2|
73962035|NCT00704184|147460560|SUPERIORITY_OR_OTHER||Adjusted difference|16.9|||||TWO_SIDED|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||40.2|-4.0|
73962036|NCT00704184|147460560|SUPERIORITY_OR_OTHER||Adjusted difference|10.7|||||TWO_SIDED|95.0|-11.4|34.6|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||34.6|-11.4|
73962037|NCT00704184|147460561|SUPERIORITY_OR_OTHER||Difference in Least Squares (LC) Means|-2.5|||||TWO_SIDED|95.0|-3.2|-1.8|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-1.8|-3.2|
73962038|NCT00704184|147460561|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.4|
74084829|NCT01214239|147723082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.552||||0.0021||95.0|1.407|4.629|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>= 7.0%||4.629|1.407|0.0021
74084830|NCT01214239|147723084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.583||||0.25||95.0|0.724|3.46|||Regression, Logistic|||Comparison by odds ratio for the patients with a baseline HbA1c \>= 6.5%||3.46|0.724|0.2500
73852447|NCT02993822|147252914|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.029|TWO_SIDED|95.0|0.1|2.2|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.2|0.1|0.029
73852448|NCT02993822|147252915|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.038|TWO_SIDED|95.0|0.1|2.3|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.3|0.1|0.038
73852449|NCT02993822|147252915|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.118|TWO_SIDED|95.0|-0.2|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|-0.2|0.118
73962039|NCT00704184|147460561|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.4|
73962040|NCT00704184|147460561|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.3|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.3|
73962041|NCT00716859|147460562|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If lower limit of 95% Confidence Interval (CI) for treatment difference is above non-inferiority margin, then non-inferiority concluded. If lower limit of 95% CI for treatment difference is above non-inferiority margin and above zero, then superiority concluded. The difference and 95% CI of the difference in IOP reduction (Week 12) was computed from an analysis of covariance (ANCOVA) model with treatment and baseline diagnosis as factors and baseline IOP as covariate.|Mean Difference (Net)|1.46|||||TWO_SIDED|95.0|-0.81|3.74||||||Null hypothesis: latanoprost inferior to timolol (0.5 percent \[%\] optionally 0.25% for participants younger than 3 years). Power calculation: assuming common standard deviation (7 mmHg), 110 participants have 84% power to demonstrate latanoprost not inferior to timolol within 3 mmHg margin, assuming latanoprost has 1 mmHg reduction more than timolol in mean change from baseline IOP.||3.74|-0.81|
73962042|NCT00716859|147460563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.68|||||TWO_SIDED|95.0|-1.66|3.02||||||||3.02|-1.66|
73962043|NCT00716859|147460564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.62|||||TWO_SIDED|95.0|-1.0|4.25||||||||4.25|-1.00|
73962044|NCT00716859|147460565|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4085|||||TWO_SIDED|95.0|-1.1|2.67||||||||2.67|-1.10|
73962045|NCT00716859|147460570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3315|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value from a Cochran-Mantel-Haenszel chi-square test stratified by baseline diagnosis (PCG vs non-PCG).||||||0.3315
73962046|NCT01351272|147460578|SUPERIORITY||||||=|0.09|||||||SPM two-sample t-test|||||||=0.09
73962047|NCT01351272|147460579|SUPERIORITY||||||=|0.16|||||||t-test, 1 sided|||||||= 0.16
73962048|NCT01351272|147460580|SUPERIORITY||||||=|0.09|||||||t-test, 1 sided|||||||= 0.09
73962049|NCT03785782|147460631|OTHER|||||||0.2988|||||||Regression, Logistic|||||||0.2988
73962050|NCT03785782|147460632|OTHER|||||||0.36|||||||Regression, Linear|||||||0.36
73962051|NCT03785782|147460633|OTHER|||||||0.43|||||||Regression, Linear|||||||0.43
73962052|NCT03785782|147460634|OTHER|||||||0.42|||||||Regression, Linear|||||||0.42
74084831|NCT01214239|147723085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.527||||0.0005||95.0|1.494|4.276|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||||4.276|1.494|0.0005
74084832|NCT01049581|147723086|NON_INFERIORITY_OR_EQUIVALENCE|ANCOVA was used and the result reveled (F1, 17 = 7.565, η2= 0.308, p = 0.007)||||||0.007|ONE_SIDED|95.0|||||ANCOVA|||null hypothesis : there is no difference in gross motor performance in pediatric aquatic therapy group and conventional therapy group||||0.007
74084833|NCT01049581|147723087|NON_INFERIORITY_OR_EQUIVALENCE|ANCOVA : p value 0.393|Mean Difference (Net)|1.762||||0.393|ONE_SIDED|95.0||||"Effect Size η2~0.023"|ANCOVA|F1,17= 0.380||We hypothesize that Children with CP receiving PAT would have better outcomes in motor function and translate to ADL||||0.393
74084834|NCT01049581|147723088|SUPERIORITY_OR_OTHER|||||||0.332|ONE_SIDED|95.0|||||ANCOVA|||null hypothesis : there is no difference in social participation between pediatric aquatic therapy group and conventional therapy group||||0.332
74084835|NCT03203642|147723089|SUPERIORITY||LS mean difference|-0.0052|STANDARD_ERROR_OF_MEAN|0.0082||0.5265|TWO_SIDED|95.0|-0.0217|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0112|-0.0217|0.5265
74084836|NCT03203642|147723090|SUPERIORITY||LS mean difference|-0.0042|STANDARD_ERROR_OF_MEAN|0.0111||0.7076|TWO_SIDED|95.0|-0.0264|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0180|-0.0264|0.7076
73852450|NCT02993822|147252915|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.025|TWO_SIDED|95.0|0.2|2.4|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.4|0.2|0.025
73852451|NCT02993822|147252916|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.258|TWO_SIDED|95.0|-0.5|1.9|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.9|-0.5|0.258
73852452|NCT02993822|147252916|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.243|TWO_SIDED|95.0|-0.5|1.8|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.8|-0.5|0.243
73852453|NCT02993822|147252916|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.009|TWO_SIDED|95.0|0.4|2.8|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.8|0.4|0.009
73852454|NCT02993822|147252917|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.008|TWO_SIDED|95.0|-16.6|-2.5|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-2.5|-16.6|0.008
73852455|NCT02993822|147252917|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.198|TWO_SIDED|95.0|-11.4|2.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.4|-11.4|0.198
73852456|NCT02993822|147252917|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.055|TWO_SIDED|95.0|-13.7|0.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||0.1|-13.7|0.055
73852457|NCT02993822|147252918|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.026|TWO_SIDED|95.0|-16.3|-1.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.1|-16.3|0.026
73852458|NCT02993822|147252918|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.571|TWO_SIDED|95.0|-9.6|5.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||5.3|-9.6|0.571
73852459|NCT02993822|147252918|SUPERIORITY||Mean Difference (Final Values)|-7.7||||0.043|TWO_SIDED|95.0|-15.2|-0.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.3|-15.2|0.043
73962053|NCT03785782|147460635|OTHER|||||||0.45|||||||Regression, Linear|||||||0.45
73962054|NCT03785782|147460636|OTHER|||||||0.18|||||||Regression, Linear|||||||0.18
73962055|NCT03785782|147460637|OTHER|||||||0.78|||||||Regression, Linear|||||||0.78
73962056|NCT03785782|147460638|OTHER|||||||0.45|||||||Regression, Linear|||||||0.45
73962057|NCT03785782|147460639|OTHER|||||||0.34|||||||Regression, Linear|||||||0.34
74084837|NCT03203642|147723091|SUPERIORITY||LS mean difference|-0.0122|STANDARD_ERROR_OF_MEAN|0.014||0.3895|TWO_SIDED|95.0|-0.0404|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0160|-0.0404|0.3895
74084838|NCT03203642|147723092|SUPERIORITY||LS mean difference|0.0015|STANDARD_ERROR_OF_MEAN|0.0131||0.9093|TWO_SIDED|95.0|-0.0248|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0278|-0.0248|0.9093
73902697|NCT01966692|147335699|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|106.0||||0.4132|TWO_SIDED|90.0|99.0|114.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 2 (B-3.8 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||114|99|0.4132
73902698|NCT01966692|147335699|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|109.0||||0.1295|TWO_SIDED|90.0|102.0|116.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||116|102|0.1295
73902699|NCT01966692|147335699|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|114.0||||0.0078|TWO_SIDED|90.0|106.0|122.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm)\*; Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||122|106|0.0078
73902700|NCT01966692|147335700|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|182.0|||<|0.001|TWO_SIDED|90.0|159.0|208.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 2 (B-3.8 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||208|159|<0.001
73902701|NCT01966692|147335700|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|190.0|||<|0.001|TWO_SIDED|90.0|166.0|217.0||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||217|166|<0.001
73902702|NCT01966692|147335700|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|213.0|||<|0.001|TWO_SIDED|90.0|186.0|244.0||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm)\*; Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||244|186|<0.001
73902703|NCT01362595|147335704|OTHER||||||||||||||||||Due to the small sample size, the statistical approach is primarily descriptive in nature.|||
73902704|NCT01083173|147335752|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||CD4 cell counts at 24 weeks as compared to baseline||||< 0.0001
73902705|NCT01083173|147335752|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||CD4 cell counts at 48 weeks as compared to baseline||||< 0.0001
73962058|NCT03785782|147460640|OTHER|||||||0.7465|||||||Regression, Logistic|||||||0.7465
73962059|NCT03785782|147460641|OTHER|||||||0.0466|||||||Regression, Logistic|||||||0.0466
74084839|NCT05068284|147723096|SUPERIORITY||Risk Difference (RD)|7.1|||||TWO_SIDED|95.0|-6.3|20.6|||||Risk difference = (ABBV-154 - placebo)|||20.6|-6.3|
74084840|NCT05068284|147723096|SUPERIORITY||Risk Difference (RD)|33.3|||||TWO_SIDED|95.0|6.7|60.0|||||Risk difference = (ABBV-154 - placebo)|||60.0|6.7|
73962060|NCT03785782|147460642|OTHER|||||||0.1567|||||||Regression, Logistic|||||||0.1567
74084841|NCT05068284|147723096|SUPERIORITY||Risk Difference (RD)|28.6|||||TWO_SIDED|95.0|4.9|52.2|||||Risk difference = (ABBV-154 - placebo)|||52.2|4.9|
73852460|NCT02993822|147252919|SUPERIORITY||Mean Difference (Final Values)|-11.5||||0.006|TWO_SIDED|95.0|-19.7|-3.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.3|-19.7|0.006
73962061|NCT03785782|147460643|OTHER|||||||0.1837|||||||Regression, Logistic|||||||0.1837
73962062|NCT03785782|147460644|OTHER|||||||0.7447|||||||Regression, Logistic|||||||0.7447
73962063|NCT03785782|147460645|OTHER|||||||0.0739|||||||Regression, Logistic|||||||0.0739
73962064|NCT03785782|147460646|OTHER|||||||0.9995|||||||Regression, Logistic|||||||0.9995
74024477|NCT04996797|147601123|SUPERIORITY||Risk Difference (RD)|10.2||||||95.0|-6.9|26.9|||||95% CI is estimated using Newcombe method for risk difference.|||26.9|-6.9|
73852461|NCT02993822|147252919|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.435|TWO_SIDED|95.0|-11.1|4.8|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.8|-11.1|0.435
74024478|NCT04996797|147601124|SUPERIORITY||Risk Difference (RD)|28.9||||||95.0|5.0|48.3|||||95% CI is estimated using Newcombe method for risk difference.|||48.3|5.0|
74024479|NCT04996797|147601125|SUPERIORITY||Risk Difference (RD)|22.2|||||TWO_SIDED|95.0|0.2|41.0|||||95% CI is estimated using Newcombe method for risk difference.|||41.0|0.2|
74024480|NCT04996797|147601126|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.0001|TWO_SIDED|95.0|14.3|39.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||39.6|14.3|<0.0001
74024481|NCT04996797|147601127|SUPERIORITY||Risk Difference (RD)|22.2||||||95.0|0.2|41.0|||||95% CI is estimated using Newcombe method for risk difference.|||41.0|0.2|
74024482|NCT04996797|147601128|SUPERIORITY||Risk Difference (RD)|33.1|||<|0.0001||95.0|17.2|46.8|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||46.8|17.2|<0.0001
73852462|NCT02993822|147252919|SUPERIORITY||Mean Difference (Final Values)|-9.4||||0.022|TWO_SIDED|95.0|-17.4|-1.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.4|-17.4|0.022
73852463|NCT02993822|147252920|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.103|TWO_SIDED|95.0|-15.3|1.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||1.4|-15.3|0.103
74024483|NCT04996797|147601129|SUPERIORITY||Risk Difference (RD)|19.6||||||95.0|-1.7|38.7|||||95% CI is estimated using Newcombe method for risk difference.|||38.7|-1.7|
74024484|NCT00741819|147601203|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.0|STANDARD_DEVIATION|35.9|<|0.001||95.0|||||Wilcoxon signed rank test]||Change in 6MWD from Baseline was calculated for patients still remaining on study at Week 12.|Analysis of endpoints was descriptive in nature. Numeric endpoints for post-baseline assessments were compared to Baseline using Wilcoxon signed rank test, and p-values were calculated for descriptive purposes; no formal hypothesis testing was planned.||||<0.001
74084842|NCT05068284|147723096|SUPERIORITY||Risk Difference (RD)|27.3|||||TWO_SIDED|95.0|1.0|53.6|||||Risk difference = (ABBV-154 - placebo)|||53.6|1.0|
74084843|NCT05068284|147723097|SUPERIORITY||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-19.8|43.6|||||Risk difference = (ABBV-154 - placebo)|||43.6|-19.8|
74084844|NCT05068284|147723097|SUPERIORITY||Risk Difference (RD)|29.5|||||TWO_SIDED|95.0|-4.8|63.8|||||Risk difference = (ABBV-154 - placebo)|||63.8|-4.8|
74084845|NCT05068284|147723097|SUPERIORITY||Risk Difference (RD)|19.0|||||TWO_SIDED|95.0|-13.7|51.8|||||Risk difference = (ABBV-154 - placebo)|||51.8|-13.7|
74084846|NCT05068284|147723097|SUPERIORITY||Risk Difference (RD)|23.3|||||TWO_SIDED|95.0|-13.6|60.3|||||Risk difference = (ABBV-154 - placebo)|||60.3|-13.6|
74084847|NCT05068284|147723098|SUPERIORITY||Risk Difference (RD)|11.3|||||TWO_SIDED|95.0|-18.5|41.0|||||Risk difference = (ABBV-154 - placebo)|||41.0|-18.5|
74084848|NCT05068284|147723098|SUPERIORITY||Risk Difference (RD)|38.5|||||TWO_SIDED|95.0|5.0|71.9|||||Risk difference = (ABBV-154 - placebo)|||71.9|5.0|
74084849|NCT05068284|147723098|SUPERIORITY||Risk Difference (RD)|24.6|||||TWO_SIDED|95.0|-7.0|56.2|||||Risk difference = (ABBV-154 - placebo)|||56.2|-7.0|
74084850|NCT05068284|147723098|SUPERIORITY||Risk Difference (RD)|39.2|||||TWO_SIDED|95.0|3.8|74.5|||||Risk difference = (ABBV-154 - placebo)|||74.5|3.8|
74084851|NCT03460990|147723103|SUPERIORITY||Least Squares (LS) Mean Difference|10.0|||<|0.0001|TWO_SIDED|95.0|7.4|12.5|||Mixed-effects model for repeated measure|||||12.5|7.4|< 0.0001
74084852|NCT03460990|147723104|SUPERIORITY||LS Mean Difference|-48.7|||<|0.0001|TWO_SIDED|95.0|-53.9|-43.5|||Mixed-effects model for repeated measure|||||-43.5|-53.9|<0.0001
74084853|NCT03460990|147723105|SUPERIORITY||LS Mean Difference|13.5|||<|0.0001|TWO_SIDED|95.0|8.8|18.3|||Mixed-effects model for repeated measure|||||18.3|8.8|<0.0001
74084854|NCT01958060|147723109|SUPERIORITY_OR_OTHER||Slope|1.0604|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|95.0|0.9901|1.1308|||||Dose proportionality was explored using linear regression model (ANOVA).The perfect dose proportionality would correspond to a slope β of 1.PK endpoints on the log-transformed scale.Standard error (SE) of the mean is actually the SE of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for Cmax was analysed.||1.1308|0.9901|
74084855|NCT01958060|147723111|SUPERIORITY_OR_OTHER||Slope|1.5629|STANDARD_ERROR_OF_MEAN|0.1056|||TWO_SIDED|95.0|1.3426|1.7833|||||Dose proportionality was explored using the linear regression model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.Standard error of the mean is actually the standard error of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for AUClast was analysed.||1.7833|1.3426|
73852464|NCT02993822|147252920|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.546|TWO_SIDED|95.0|-10.6|5.6|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||5.6|-10.6|0.546
74084856|NCT02304406|147723113|OTHER||Odds Ratio (OR)|1.85||||0.1304|TWO_SIDED|95.0|0.8|4.77|||Cochran-Mantel-Haenszel|||||4.77|0.80|0.1304
74084857|NCT02304406|147723114|OTHER|||||||0.6422|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6422
74084858|NCT02304406|147723115|OTHER|||||||0.4524|||||||Cochran-Mantel-Haenszel|||||||0.4524
74084859|NCT02304406|147723116|OTHER|||||||0.901|||||||Cochran-Mantel-Haenszel|||||||0.9010
74084860|NCT02304406|147723117|OTHER|||||||0.9067|||||||Cochran-Mantel-Haenszel|||||||0.9067
74024485|NCT00741819|147601204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_DEVIATION|7.7|<|0.001|||||||Wilcoxon signed rank test||Analysis based on Total CAMPHOR Score.|||||<0.001
74024486|NCT00741819|147601205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|21.3||0.895||95.0|||||Wilcoxon signed-rank test||Side-Effects Score, change from Baseline to Week 12|||||0.895
74024487|NCT00741819|147601205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.3|STANDARD_DEVIATION|25.9|<|0.001||95.0|||||Wilcoxon signed-rank test||Convenience Score, change from Baseline to Week 12|||||<0.001
74024488|NCT00741819|147601205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|STANDARD_DEVIATION|23.7|<|0.001||95.0|||||Wilcoxon signed-rank test||Global Satisfaction, change from Baseline to Week 12|||||<0.001
74024489|NCT00741819|147601205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.9|STANDARD_DEVIATION|21.5|<|0.001||95.0|||||Wilcoxon signed rank test||Effectiveness score, change from Baseline to Week 12|||||<0.001
74024490|NCT00741819|147601207|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon signed-rank test|||||||0.001
74024491|NCT01126580|147601210|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.36|-0.08||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of 1.5 mg LY2189265 vs Metformin on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 2-sided alpha of 0.05 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 11%.||-0.08|-0.36|<0.001
74024492|NCT01126580|147601210|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.15|||<|0.001|TWO_SIDED|95.0|-0.29|-0.01||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.01|-0.29|<0.001
74084861|NCT02304406|147723118|OTHER|||||||0.8785|||||||Cochran-Mantel-Haenszel|||||||0.8785
74084862|NCT02304406|147723119|OTHER|||||||0.9231|||||||Cochran-Mantel-Haenszel|||||||0.9231
74084863|NCT02304406|147723120|OTHER|||||||0.978|||||||Cochran-Mantel-Haenszel|||||||0.9780
74084864|NCT02304406|147723121|OTHER|||||||0.1144|||||||Cochran-Mantel-Haenszel|||||||0.1144
74084865|NCT02304406|147723122|OTHER|||||||0.0862|||||||Cochran-Mantel-Haenszel|||||||0.0862
74084866|NCT02304406|147723123|OTHER|||||||0.0294|||||||Cochran-Mantel-Haenszel|||||||0.0294
74084867|NCT02304406|147723124|OTHER|||||||0.6877|||||||Cochran-Mantel-Haenszel|||||||0.6877
73962065|NCT03779048|147460649|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|0.11||||0.24|TWO_SIDED||||||Regression, Linear|Controls for postprandial increases in GLP-1 and gastric emptying (acetaminophen tests)||||||.24
73962066|NCT03779048|147460650|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|-0.09||||0.34|TWO_SIDED||||||Regression, Linear|Controls for baseline postprandial satiety and gastric emptying (acetaminophen test)||||||.34
74024493|NCT01126580|147601210|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.002|TWO_SIDED|95.0|-0.36|-0.08||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.08|-0.36|0.002
74024494|NCT01126580|147601210|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.02|TWO_SIDED|95.0|-0.29|-0.01||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.01|-0.29|0.020
74024495|NCT01126580|147601211|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.19|||<|0.001|TWO_SIDED|95.0|-0.35|-0.02||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.02|-0.35|<0.001
74024496|NCT01126580|147601211|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.04|||<|0.001|TWO_SIDED|95.0|-0.2|0.12||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||0.12|-0.20|<0.001
74024497|NCT01126580|147601211|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.024|TWO_SIDED|95.0|-0.35|-0.02||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.02|-0.35|0.024
74024498|NCT01126580|147601211|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.299|TWO_SIDED|95.0|-0.2|0.12||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||0.12|-0.20|0.299
74024499|NCT01126580|147601212|SUPERIORITY_OR_OTHER|||||||0.023||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.023
74024500|NCT01126580|147601212|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.021
74024501|NCT01126580|147601212|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||<0.001
74024502|NCT01126580|147601212|SUPERIORITY_OR_OTHER|||||||0.011||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.011
74024503|NCT01126580|147601212|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.001
74024504|NCT01126580|147601212|SUPERIORITY_OR_OTHER|||||||0.269||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.269
74024505|NCT01126580|147601212|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||<0.001
74024506|NCT01126580|147601212|SUPERIORITY_OR_OTHER|||||||0.134||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.134
74024507|NCT01126580|147601213|SUPERIORITY_OR_OTHER|||||||0.079||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.079
74024508|NCT01126580|147601213|SUPERIORITY_OR_OTHER|||||||0.451||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.451
74024509|NCT01126580|147601213|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.025
74024510|NCT01126580|147601213|SUPERIORITY_OR_OTHER|||||||0.402||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.402
74024511|NCT01126580|147601214|SUPERIORITY_OR_OTHER|||||||0.061||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.061
74024512|NCT01126580|147601214|SUPERIORITY_OR_OTHER|||||||0.647||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.647
74024513|NCT01126580|147601214|SUPERIORITY_OR_OTHER|||||||0.022||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.022
74024514|NCT01126580|147601214|SUPERIORITY_OR_OTHER|||||||0.469||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.469
74024515|NCT01126580|147601215|SUPERIORITY_OR_OTHER|||||||0.811||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.811
74024516|NCT01126580|147601215|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.003
74024517|NCT01126580|147601215|SUPERIORITY_OR_OTHER|||||||0.44||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.440
74024518|NCT01126580|147601215|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.001
74024519|NCT01126580|147601216|SUPERIORITY_OR_OTHER|||||||0.75||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.750
74024520|NCT01126580|147601216|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.003
74024521|NCT01126580|147601216|SUPERIORITY_OR_OTHER|||||||0.412||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.412
74024522|NCT01126580|147601216|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.001
74024523|NCT01126580|147601217|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis|||||||<0.001
74024524|NCT01126580|147601217|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis|||||||<0.001
74024525|NCT01126580|147601217|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis|||||||<0.001
74024526|NCT01126580|147601217|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis|||||||0.003
74024527|NCT01126580|147601217|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis|||||||0.001
74024528|NCT01126580|147601217|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis|||||||0.010
73962067|NCT03779048|147460651|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|0.03||||0.78|TWO_SIDED||||||Regression, Linear|Controls for baseline postprandial satiety and postprandial change in GLP-1||||||.78
73962068|NCT03779048|147460652|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.0||0.003|TWO_SIDED|95.0|1.1|5.1|||Mixed Models Analysis|||||5.1|1.1|.003
73962069|NCT03779048|147460653|OTHER|Correlation between baseline postprandial hunger AUC and 4-week percent weight loss.|r|-0.1||||0.23|TWO_SIDED||||||Regression, Linear|||||||.23
73962070|NCT03779048|147460654|OTHER|Correlation between baseline high energy density food reinforcer points earned and 4-week percent weight loss.|r|-0.1||||0.23|TWO_SIDED||||||Regression, Linear|||||||.23
73962071|NCT03779048|147460655|OTHER|Regression results using baseline AUC for delay discounting to predict 4-week percent weight loss, controlling for participant age.|r2 change|0.033||||0.033|TWO_SIDED||||||Regression, Linear|||||||.033
73962072|NCT03779048|147460656|OTHER|Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.|r|0.17||||0.04|TWO_SIDED|||||Correlation to Implicit wanting of High Fat Savory.|Regression, Linear|||||||.04
74024529|NCT01126580|147601217|SUPERIORITY_OR_OTHER|||||||0.077||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis|||||||0.077
74024530|NCT01126580|147601217|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis|||||||0.004
74024531|NCT04194944|147601291|SUPERIORITY||Hazard Ratio (HR)|0.465||||0.0002|TWO_SIDED|95.0|0.309|0.699|||Log Rank|||||0.699|0.309|0.0002
74024532|NCT04194944|147601292|SUPERIORITY||Hazard Ratio (HR)|0.482||||0.0001|TWO_SIDED|95.0|0.331|0.7|||Log Rank|||||0.700|0.331|0.0001
74024533|NCT04194944|147601293|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3996|TWO_SIDED|95.0|0.7|3.4|||Cochran-Mantel-Haenszel|||||3.4|0.7|0.3996
74024534|NCT04194944|147601294|SUPERIORITY||Odds Ratio (OR)|1.7||||0.139|TWO_SIDED|95.0|0.9|3.6|||Cochran-Mantel-Haenszel|||||3.6|0.9|0.1390
73962073|NCT03779048|147460656|OTHER|Correlation to Implicit wanting of Low Fat Savory.|r|-0.03||||0.72|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included taughter in the same analysis, so separate correlations were conducted.||||.72
74024535|NCT04194944|147601297|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0028|TWO_SIDED|95.0|1.4|5.1|||Cochran-Mantel-Haenszel|||||5.1|1.4|0.0028
73962074|NCT03779048|147460656|OTHER|Correlation to Implicit wanting of High Fat Sweet.|r|0.01||||0.94|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.||||.94
73962075|NCT03779048|147460656|OTHER|Correlation to Implicit wanting of Low Fat Sweet.|r|-0.15||||0.09|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.||||.09
73962076|NCT03779048|147460657|OTHER|Correlation between baseline fasting active ghrelin and 4-week percent weight loss.|r|0.03||||0.73|TWO_SIDED||||||Regression, Linear|||||||.73
73962077|NCT03779048|147460658|OTHER||r|-0.1||||0.25|TWO_SIDED||||||Regression, Linear|||Correlation between baseline fasting leptin and 4-week percent weight loss.||||.25
73962078|NCT03779048|147460659|OTHER|Correlation between baseline postprandial AUC for change in insulin and 4-week percent weight loss.|r|-0.03||||0.72|TWO_SIDED||||||Regression, Linear|||||||.72
73962079|NCT03779048|147460660|OTHER|Correlation between baseline postprandial incremental AUC for PYY and 4-week percent weight loss.|r|-0.02||||0.82|TWO_SIDED||||||Regression, Linear|||||||.82
73962080|NCT03779048|147460661|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.002|TWO_SIDED|95.0|1.1|5.0|||Mixed Models Analysis|||||5.0|1.1|.002
73962081|NCT03779048|147460666|SUPERIORITY|Difference between placebo- and phentermine-treated participants in change in delay discounting area under the curve from randomization to week 24 was calculated using repeated measures ANCOVA, controlling for age.|F|0.17||||0.68|TWO_SIDED||||||ANCOVA|||||||.68
73962082|NCT03779048|147460667|OTHER|Regression using the three Eating Inventory subscales (Cognitive restraint, disinhibition, hunger) to predict 4-week weight loss|r2|0.01||||0.75|TWO_SIDED|||||For full model including all 3 predictors|Regression, Linear|||||||.75
73962083|NCT03779048|147460668|OTHER|Correlation between baseline past-week appetite and 4-week percent weight loss.|r|-0.09||||0.31|TWO_SIDED||||||Regression, Linear|||||||.31
74024536|NCT04194944|147601298|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0003|TWO_SIDED|95.0|1.6|5.2|||Cochran-Mantel-Haenszel|||||5.2|1.6|0.0003
74024537|NCT04194944|147601299|SUPERIORITY||Hazard Ratio (HR)|0.377||||0.0001|TWO_SIDED|95.0|0.224|0.633|||Log Rank|||||0.633|0.224|0.0001
74024538|NCT04194944|147601300|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.0004|TWO_SIDED|95.0|0.256|0.684|||Log Rank|||||0.684|0.256|0.0004
74024539|NCT04194944|147601303|SUPERIORITY||Odds Ratio (OR)|3.2||||0.1809|TWO_SIDED|95.0|0.8|12.8|||Cochran-Mantel-Haenszel|||||12.8|0.8|0.1809
74024540|NCT04194944|147601304|SUPERIORITY||Odds Ratio (OR)|5.2||||0.0167|TWO_SIDED|95.0|1.4|19.6|||Cochran-Mantel-Haenszel|||||19.6|1.4|0.0167
74024541|NCT01485614|147601342|SUPERIORITY||Least Squares Means Difference|-0.19|||=|0.448|TWO_SIDED|95.0|-0.68|0.3|||Mixed Models Analysis|"The Least Squares (LS) Mean for the arm Sitagliptin is compared against that of Placebo (pooled)."||||0.30|-0.68|= 0.448
74024542|NCT01485614|147601344|OTHER||Difference in Percentage|2.4|||||TWO_SIDED|95.0|-10.0|14.9||"Percentage of participants with ≥1 adverse event for the arm Sitagliptin was compared against that of Placebo/Metformin with Miettinen \& Nurminen."||||||14.9|-10.0|
74024543|NCT01485614|147601346|OTHER||Difference in percentage|4.2|||||TWO_SIDED|95.0|-1.3|10.8||"Percentage of participants with ≥1 adverse event for the arm Sitagliptin was compared against that of Placebo/Metformin with Miettinen \& Nurminen."||||||10.8|-1.3|
73852465|NCT02993822|147252920|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.034|TWO_SIDED|95.0|-17.2|-0.7|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.7|-17.2|0.034
73852466|NCT02993822|147252921|SUPERIORITY||Mean Difference (Final Values)|-11.2||||0.004|TWO_SIDED|95.0|-18.8|-3.6|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.6|-18.8|0.004
73852467|NCT02993822|147252921|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.282|TWO_SIDED|95.0|-11.5|3.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||3.4|-11.5|0.282
73852468|NCT02993822|147252921|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.398|TWO_SIDED|95.0|-10.7|4.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.3|-10.7|0.398
73852469|NCT02993822|147252922|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.019|TWO_SIDED|95.0|-18.3|-1.7|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.7|-18.3|0.019
73852470|NCT02993822|147252922|SUPERIORITY||Mean Difference (Final Values)|-5.6||||0.17|TWO_SIDED|95.0|-13.7|2.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.4|-13.7|0.170
73852471|NCT02993822|147252922|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.384|TWO_SIDED|95.0|-11.7|4.5|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.5|-11.7|0.384
73852472|NCT02993822|147252923|SUPERIORITY||Mean Difference (Final Values)|-11.7||||0.006|TWO_SIDED|95.0|-20.0|-3.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.3|-20.0|0.006
73852473|NCT02993822|147252923|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.222|TWO_SIDED|95.0|-13.0|3.0|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||3.0|-13.0|0.222
73852474|NCT02993822|147252923|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.058|TWO_SIDED|95.0|-16.0|0.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||0.3|-16.0|0.058
73852475|NCT02993822|147252924|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.027|TWO_SIDED|95.0|-18.9|-1.2|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.2|-18.9|0.027
73962084|NCT03779048|147460670|OTHER|Regression using baseline scores for Behavioral Inhibition (BIS) and Behavioral Activation fro Reward to predict 4-week weight loss during the behavioral treatment run-in.|r2|0.05||||0.03|TWO_SIDED||||||Regression, Linear|||||||.03
73852476|NCT02993822|147252924|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.147|TWO_SIDED|95.0|-14.9|2.2|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.2|-14.9|0.147
73852477|NCT02993822|147252924|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.046|TWO_SIDED|95.0|-17.6|-0.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.1|-17.6|0.046
73852478|NCT02993822|147252925|SUPERIORITY||Mean Difference (Final Values)|-12.5|||<|0.001|TWO_SIDED|95.0|-19.5|-5.5|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-5.5|-19.5|<0.001
73962085|NCT03779048|147460671|OTHER|Correlation between baseline BIS-15 total score and 4-week percent weight loss.|r|0.03||||0.76|TWO_SIDED||||||Regression, Linear|||||||.76
74084868|NCT04284553|147723127|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.97|1.49|||||"The Odds Ratio compares having open encounter as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having an open encounter alert in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the trial and adjusting for provider-level clustering.||1.49|0.97|
74084869|NCT04284553|147723127|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.59|||||"The OR compares between having boostering as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having boostering in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.59|0.83|
74084870|NCT04284553|147723127|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.61|1.16|||||"The OR compares between having cold-state priming as an intervention factor in the arm the patient's primary care providers were assigned to vs. all others not having cold-state priming in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.16|0.61|
74084871|NCT04284553|147723127|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.88|1.64|||||"The OR compares between having simplification as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having simplification in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.64|0.88|
74084872|NCT04284553|147723127|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.52|0.98|||||"The OR compares between having sign-off approval as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having sign-off approval in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||0.98|0.52|
74084873|NCT04284553|147723127|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||"The OR compares between having pre-commitment as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having pre-commitment in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.64|0.89|
74084874|NCT04284553|147723127|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.55|1.19|||||"The OR compares patients having risk framing as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having risk framing in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.19|0.55|
73962086|NCT05777785|147460698|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|0.9789||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
73962087|NCT05777785|147460700|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|2.09||||0.027|TWO_SIDED||||||t-test, 2 sided|||||||0.027
74024544|NCT01485614|147601349|SUPERIORITY||Difference in percentage|6.7|||=|0.374|TWO_SIDED|95.0|-8.1|21.2||"Percentage of participants with an A1C goal (7.0%) in the arm Sitagliptin was compared against the arm Placebo (pooled)."|Miettinen and Nurminen||||For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method based on the Linear Discriminant Analysis (LDA) model was used to impute whether the participant had met the goal.|21.2|-8.1|= 0.374
74024545|NCT01485614|147601351|SUPERIORITY||Difference in percentage|3.6|||=|0.639|TWO_SIDED|95.0|-11.6|18.3|||Miettinen and Nurminen|"The percentage of participants with an A1C at the A1C goal (6.5%) in the arm Sitagliptin was compared against the arm Placebo (pooled)."|||For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method based on the LDA model was used to impute whether the participant had met the goal.|18.3|-11.6|= 0.639
74024546|NCT01485614|147601356|SUPERIORITY||Least Squares Means Difference|1.5|||=|0.849|TWO_SIDED|95.0|-14.4|17.5|||Mixed Models Analysis|"The Least Squares (LS) Mean for the arm Sitagliptin was compared against that of Placebo (pooled)."||||17.5|-14.4|= 0.849
74024547|NCT02210780|147601435|SUPERIORITY||Percentage Difference|34.0|||<|0.0001|TWO_SIDED|90.0|24.29|43.75|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||43.75|24.29|<0.0001
74024548|NCT02210780|147601436|SUPERIORITY||Percentage Difference|40.2|||<|0.0001|TWO_SIDED|90.0|29.4|51.01|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||51.01|29.40|<0.0001
73852479|NCT02993822|147252925|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.114|TWO_SIDED|95.0|-12.4|1.3|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||1.3|-12.4|0.114
74024549|NCT02210780|147601437|SUPERIORITY||Percentage Difference|34.0|||<|0.0001|TWO_SIDED|90.0|23.38|44.66|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||44.66|23.38|<0.0001
74024550|NCT02210780|147601438|SUPERIORITY||LS Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.354|<|0.0001|TWO_SIDED|90.0|-2.72|-1.55|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model which includes treatment, randomization strata, and baseline value as covariates.||-1.55|-2.72|<0.0001
73852480|NCT02993822|147252925|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.056|TWO_SIDED|95.0|-13.7|0.2|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||0.2|-13.7|0.056
73852481|NCT02993822|147252926|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.027|TWO_SIDED|95.0|-16.8|-1.0|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-1.0|-16.8|0.027
74024551|NCT02210780|147601439|SUPERIORITY||LS Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|TWO_SIDED|90.0|-22.5|-13.1|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model that includes treatment, randomization strata and baseline value as covariates.||-13.1|-22.5|<0.0001
74024552|NCT02210780|147601441|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|90.0|-3.0|-1.7|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which includes treatment, randomization strata, and baseline values as covariates.||-1.7|-3.0|<0.0001
73852482|NCT02993822|147252926|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.357|TWO_SIDED|95.0|-11.3|4.1|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||4.1|-11.3|0.357
73852483|NCT02993822|147252926|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.031|TWO_SIDED|95.0|-16.2|-0.8|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-0.8|-16.2|0.031
73852484|NCT02993822|147252927|SUPERIORITY||Mean Difference (Final Values)|-11.1||||0.008|TWO_SIDED|95.0|-19.2|-2.9|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-2.9|-19.2|0.008
73852485|NCT02993822|147252927|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.321|TWO_SIDED|95.0|-11.8|3.9|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||3.9|-11.8|0.321
73852486|NCT02993822|147252927|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.047|TWO_SIDED|95.0|-16.0|-0.1|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-0.1|-16.0|0.047
73962088|NCT05777785|147460701|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|2.09||||0.029|TWO_SIDED||||||t-test, 2 sided|||||||0.029
73962089|NCT04588259|147460708|NON_INFERIORITY|The upper limit of the 95% confidence interval (CI) for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.|Treatment difference|-0.05||||0.5102|TWO_SIDED|95.0|-0.19|0.09||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|Mixed Models Analysis|||The outcome measure was analysed using mixed-effect model for repeated measurement (MMRM) where all calculated changes in HbA1c from baseline at visits were included in analysis. Model included treatment and stratification of type 1 diabetes mellitus/ type 2 diabetes mellitus (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix described the variability for the repeated measurements for a participant.||0.09|-0.19|0.5102
74024553|NCT02210780|147601442|SUPERIORITY||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|90.0|-9.9|-6.6|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which included treatment, randomization strata, and baseline value as covariates.||-6.6|-9.9|<0.0001
74024554|NCT01486264|147601448|NON_INFERIORITY|Analysis of covariance (ANCOVA) model adjusted for the baseline TWSTRS Severity subscale score, was used to test the non-inferiority of Short Flex versus Long Flex treatment. Non-inferiority margin delta equal to (=) 2 points.|Least Square (LS) Mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.9|0.1||||||||0.1|-2.9|
74024555|NCT00768560|147601490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.69||||||90.0|-12.62|-6.77|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the analysis of variance (ANOVA) model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||-6.77|-12.62|
74024556|NCT00768560|147601490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||||90.0|-2.87|2.98|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||2.98|-2.87|
74088269|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|3.8||0.0079|TWO_SIDED|95.0|-17.85|-2.77|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.77|-17.85|0.0079
74024557|NCT00768560|147601490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.75||||||90.0|6.83|12.67|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||12.67|6.83|
73962090|NCT04588259|147460709|NON_INFERIORITY|The upper limit of the 95% CI for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.|Treatment Difference|-0.52||||0.5102|TWO_SIDED|95.0|-2.08|1.03||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|Mixed Models Analysis|||The outcome measure was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits are included in the analysis. The model includes treatment and stratification (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix is used to describe the variability for the repeated measurements for a participant.||1.03|-2.08|0.5102
74024558|NCT00768560|147601490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.97||||||90.0|-5.5|-2.44|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||-2.44|-5.50|
73962091|NCT02763319|147460738|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.468|TWO_SIDED|95.0|0.837|1.351|||Inverse normal test|The Inverse Normal method combines information (p-value) from the interim analysis and information from the final analysis.|The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per the Interactive Web Response System (IWRS). Rituximab + bendamustine was the reference treatment group.|||1.351|0.837|0.468
73962092|NCT02763319|147460739|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.568|TWO_SIDED|95.0|0.586|1.33|||Inverse normal test|The Inverse Normal method combines information (p-value) from the interim analysis and information from the final analysis.|The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per the Interactive Web Response System. Rituximab + bendamustine is the reference treatment group.|||1.330|0.586|0.568
73962093|NCT02763319|147460740|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.812|1.779|||||||A Cochran-Mantel-Haenszel (CMH) test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|1.779|0.812|
74024559|NCT00768560|147601490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||||90.0|-2.21|0.85|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||0.85|-2.21|
74024560|NCT00768560|147601490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.29||||||90.0|1.76|4.82|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||4.82|1.76|
74024561|NCT01128387|147601497|OTHER||Maximum Tolerated Dose|1.5|||||TWO_SIDED|||||||||Dose of Pantiumumab (in combination with Cisplatin \& Fluorouracil - see below)||||
74024562|NCT01128387|147601497|OTHER||Maximum Tolerated Dose|60.0|||||TWO_SIDED|||||||||Dose of Cisplatin||||
74088270|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-10.56|STANDARD_ERROR_OF_MEAN|4.0||0.0096|TWO_SIDED|95.0|-18.49|-2.63|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.63|-18.49|0.0096
73962094|NCT02763319|147460741|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.778|3.041|||||||A Cochran-Mantel-Haenszel (CMH) test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|3.041|0.778|
73962095|NCT02763319|147460742|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.938|1.745|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.745|0.938|
74024563|NCT01128387|147601497|OTHER||Maximum Tolerated Dose|750.0|||||TWO_SIDED|||||||||Dose of Fluorourcil||||
73962096|NCT02763319|147460743|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.673|2.035|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|2.035|0.673|
73962097|NCT02763319|147460744|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.875|1.452|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.452|0.875|
74024564|NCT01535235|147601502|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
74024565|NCT01535235|147601503|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
74024566|NCT01021111|147601505|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||The values from the three jumps were averaged in order to have one mean value per subject per session. Paired Student t-tests (baseline vs. follow-up) were used to evaluate the effects of the training.||||<0.01
73962098|NCT02763319|147460745|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.682|1.626|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.626|0.682|
73962099|NCT02763319|147460746|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.829|1.985|||||||A CMH test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|1.985|0.829|
73962100|NCT02763319|147460747|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|0.755|3.457|||||||A CMH test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|3.457|0.755|
73962101|NCT02763319|147460748|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.831|1.416|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.416|0.831|
73962102|NCT02763319|147460749|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.633|1.595|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.595|0.633|
73962103|NCT02763319|147460750|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.794|1.244|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.244|0.794|
73852487|NCT02993822|147252928|SUPERIORITY||Mean Difference (Final Values)|-10.1||||0.018|TWO_SIDED|95.0|-18.4|-1.8|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-1.8|-18.4|0.018
73962104|NCT02763319|147460751|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.57|1.22|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.220|0.570|
73962105|NCT00232180|147460770|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.535|0.741||Using an adaptation of Haybittle-Peto stopping criterion adjusting for two interim analyses, p-value for final primary analysis will be compared to alpha=0.049. No adjustment in alpha will be made on parameters/endpoints other than primary endpoint.|Cox proportional hazard model|||Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, time from electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) and atrial fibrillation as covariates.||0.741|0.535|<0.0001
73962106|NCT00232180|147460772|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.647|||<|0.0001|TWO_SIDED|95.0|0.552|0.757||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.757|0.552|<0.0001
73962107|NCT00232180|147460773|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.761||||0.0081|TWO_SIDED|95.0|0.622|0.932||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.932|0.622|0.0081
73852488|NCT02993822|147252928|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.682|TWO_SIDED|95.0|-9.8|6.4|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||6.4|-9.8|0.682
73852489|NCT02993822|147252928|SUPERIORITY||Mean Difference (Final Values)|-11.8||||0.005|TWO_SIDED|95.0|-20.0|-3.6|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-3.6|-20.0|0.005
73852490|NCT02993822|147252929|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.004
73852491|NCT02993822|147252929|SUPERIORITY|||||||0.134|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.134
73852492|NCT02993822|147252929|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.003
73852493|NCT02993822|147252930|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.401
73852494|NCT02993822|147252930|SUPERIORITY|||||||0.175|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.175
73852495|NCT02993822|147252930|SUPERIORITY|||||||0.126|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.126
73852496|NCT02993822|147252931|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.002
73852497|NCT02993822|147252931|SUPERIORITY|||||||0.144|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.144
73852498|NCT02993822|147252931|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.025
73852499|NCT02993822|147252932|SUPERIORITY|||||||0.158|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.158
73852500|NCT02993822|147252932|SUPERIORITY|||||||0.597|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.597
73852501|NCT02993822|147252932|SUPERIORITY|||||||0.124|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.124
73852502|NCT02993822|147252933|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.01
73852503|NCT02993822|147252933|SUPERIORITY|||||||0.049|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.049
73852504|NCT02993822|147252933|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.001
73852505|NCT02993822|147252934|SUPERIORITY|||||||0.309|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.309
73852506|NCT02993822|147252934|SUPERIORITY|||||||0.387|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.387
73852507|NCT02993822|147252934|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.025
73852508|NCT02993822|147252935|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.003
73852509|NCT02993822|147252935|SUPERIORITY|||||||0.152|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.152
73852510|NCT02993822|147252935|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.004
73852511|NCT02993822|147252936|SUPERIORITY|||||||0.1|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.100
73852512|NCT02993822|147252936|SUPERIORITY|||||||0.557|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.557
73852513|NCT02993822|147252936|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.054
73852514|NCT01939977|147252950|SUPERIORITY|||||||0.0083|||||||Chi-squared|||"Taking per protocol population, the percentage of patients with iPTH\> 110 pg / ml at 6 months post-transplant treated with Paricalcitol was statistically lower than in patients treated with Calcifediol"||||0.0083
73962108|NCT00232180|147460774|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.757||||0.012|TWO_SIDED|95.0|0.609|0.941||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.941|0.609|0.0120
73962109|NCT00232180|147460775|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.768|||<|0.0001|TWO_SIDED|95.0|0.673|0.876||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.876|0.673|<0.0001
73852515|NCT05285644|147252976|OTHER|Difference (2-sided)|Difference in Percentages|34.4|||<|0.0001|TWO_SIDED|95.0|26.9|42.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|42.0|26.9|<0.0001
73852516|NCT05285644|147252977|OTHER|Difference (2-sided)|Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|2.06||0.0138|TWO_SIDED|95.0|-9.1|-1.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||-1.0|-9.1|0.0138
73852517|NCT05285644|147252978|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.2|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|5.8|8.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|8.6|5.8|<0.0001
73852518|NCT05285644|147252979|OTHER|Difference (2-sided)|Difference in Percentages|26.7|||<|0.0001|TWO_SIDED|95.0|19.5|34.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|34.0|19.5|<0.0001
73852519|NCT05285644|147252980|OTHER|Difference (2-sided)|Least Squares Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|4.9|7.5||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||7.5|4.9|<0.0001
73852520|NCT05285644|147252981|OTHER|Difference (2 sided)|Difference in Percentages|33.1|||<|0.0001|TWO_SIDED|95.0|24.8|41.4||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|41.4|24.8|<0.0001
73962110|NCT00232180|147460776|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.576|||<|0.0001|TWO_SIDED|95.0|0.473|0.702||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.702|0.473|<0.0001
73962111|NCT00232180|147460777|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.751|||<|0.0001|TWO_SIDED|95.0|0.664|0.849||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.849|0.664|<0.0001
73852521|NCT05285644|147252982|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.5|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|95.0|6.0|9.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.0|6.0|<0.0001
73852522|NCT05285644|147252983|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.28||0.2184|TWO_SIDED|95.0|-7.3|1.7||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.7|-7.3|0.2184
73852523|NCT05285644|147252984|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|2.43||0.266|TWO_SIDED|94.0|-7.5|2.1||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||2.1|-7.5|0.2660
73852524|NCT05285644|147252985|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|2.37||0.2741|TWO_SIDED|95.0|-7.2|2.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||2.0|-7.2|0.2741
73852525|NCT05285644|147252986|OTHER|Difference (2-sided)|Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.43||0.159|TWO_SIDED|95.0|-8.2|1.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.3|-8.2|0.1590
73852526|NCT05285644|147252987|OTHER|Difference (2-sided)|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.67||0.1369|TWO_SIDED|95.0|-9.2|1.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.3|-9.2|0.1369
73852527|NCT01696981|147253014|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.95|1.0|||Poisson regression|||||1.00|0.95|
73852528|NCT01696981|147253016|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.85|||Poisson regression|||||0.85|0.72|
73852529|NCT01696981|147253018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.63|0.87|||Poisson regression|||||0.87|0.63|
73852530|NCT03335150|147253037|OTHER|Equality|Mean Difference (Final Values)|0.4856||||0.6662|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = Standard Error (SE) of the interaction term.|||||0.6662
73852531|NCT03335150|147253037|OTHER|Equality|Mean Difference (Final Values)|0.2415||||0.1617|TWO_SIDED||||||Mixed Models Analysis|Mean Matrix Reasoning Total (MRT) difference between two visits while controlling for intervention.|estimated value = SE|||||0.1617
73852532|NCT03335150|147253037|OTHER|Equality|Mean Difference (Final Values)|0.5087||||0.6236|TWO_SIDED||||||Mixed Models Analysis|Mean MRT difference between two interventions while controlling for visit.|estimated value = SE|||||0.6236
73852533|NCT03335150|147253038|OTHER|Equality|Mean Difference (Final Values)|0.58||||0.0496|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated value = SE of interaction term|||||0.0496
73852534|NCT03335150|147253039|OTHER|Equality|Mean Difference (Final Values)|1.62||||0.047|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.047
73852535|NCT03335150|147253040|OTHER|Equality|Mean Difference (Final Values)|2.97||||0.001|TWO_SIDED|||||Interaction Term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.001
73852536|NCT03335150|147253041|OTHER|Equality|Mean Difference (Final Values)|2.25||||0.02|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.020
73852537|NCT03335150|147253042|OTHER|Equality|Mean Difference (Final Values)|1.26||||0.444|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.444
73852538|NCT03335150|147253042|OTHER|Equality|Mean Difference (Final Values)|1.145||||0.0233|TWO_SIDED||||||Mixed Models Analysis|There is significant difference in MIST between intervention groups controlling for visit and other significant covariates.|estimated value = SE|||||0.0233
73852539|NCT03335150|147253042|OTHER|Equality|Mean Difference (Final Values)|0.6281|||<|0|TWO_SIDED||||||Mixed Models Analysis|There is significant difference in MIST between baseline and week 10 controlling for intervention group and other significant covariates|estimated value = SE|||||<0.000
73852540|NCT03335150|147253043|OTHER|Equality|Mean Difference (Final Values)|2.205||||0.073|TWO_SIDED|||||Interaction term|Mixed Models Analysis||estimated value = SE of interaction term|||||0.073
73852541|NCT03335150|147253044|OTHER|Equality|Mean Difference (Final Values)|2.25||||0.82|TWO_SIDED|||||Interaction Term|Mixed Models Analysis|||||||0.82
73852542|NCT03335150|147253044|OTHER|Equality|Mean Difference (Final Values)|1.1172||||0.0257|TWO_SIDED||||||Mixed Models Analysis|Mean PDQ-39 difference between baseline and week 10 controlling for intervention and covariates.|estimated value = SE|||||0.0257
73852543|NCT03335150|147253044|OTHER|Equality|Mean Difference (Final Values)|3.8649||||0.1101|TWO_SIDED||||||Mixed Models Analysis|Difference in PDQ-39 between two interventions controlling for visit and covariates.|estimated value = SE|||||0.1101
73852544|NCT03335150|147253045|OTHER|Equality|Median Difference (Final Values)|1.784||||0.0263|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of the interaction term.|||||0.0263
73852545|NCT03823287|147253053|NON_INFERIORITY|If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.1|2.5|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.||2.5|-1.1|
73852546|NCT03823287|147253054|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-1.2|2.7|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||2.7|-1.2|
73852547|NCT03823287|147253056|OTHER||Difference in CMH Weighted Percentage|4.3|||||TWO_SIDED|95.0|-1.6|10.1|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥15 Letters: Treatment Difference at Weeks 40-48||10.1|-1.6|
73852548|NCT03823287|147253056|OTHER||Difference in CMH Weighted Percentage|5.4|||||TWO_SIDED|95.0|-2.0|12.7|||||The treatment difference in CMH weighted percentage of participants gaining ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥10 Letters: Treatment Difference at Weeks 40-48||12.7|-2.0|
74024567|NCT01021111|147601506|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Pearson|||The association between the change in the thigh coronal angular velocity from baseline to follow-up and the change in the knee abduction moment from baseline to follow-up was assessed with the Pearson correlation coefficient (R), alpha =0.05||||<0.05
74024568|NCT00389207|147601507|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.016||||0.684||95.0|-0.062|0.095||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Controlling for screening VL and CD4+ categories (only 373 NVP patients due to empty cells)||||0.095|-0.062|0.684
73852549|NCT03823287|147253056|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-6.6|8.9|||||The treatment difference in CMH weighted percentage of participants gaining ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥5 Letters: Treatment Difference at Weeks 40-48||8.9|-6.6|
73852550|NCT03823287|147253056|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-7.9|5.4|||||The treatment difference in CMH weighted percentage of participants gaining ≥0 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥0 Letters: Treatment Difference at Weeks 40-48||5.4|-7.9|
73852551|NCT03823287|147253057|OTHER||Difference in CMH Weighted Percentage|2.7|||||TWO_SIDED|95.0|-3.2|8.5|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||8.5|-3.2|
73852552|NCT03823287|147253062|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-2.2|4.8|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥15 Letters: Treatment Difference at Weeks 40-48||4.8|-2.2|
73852553|NCT03823287|147253062|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-4.6|3.9|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥10 Letters: Treatment Difference at Weeks 40-48||3.9|-4.6|
73852554|NCT03823287|147253062|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-4.0|6.4|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥5 Letters: Treatment Difference at Weeks 40-48||6.4|-4.0|
73852555|NCT03823287|147253063|OTHER||Difference in CMH Weighted Percentage|-0.2|||||TWO_SIDED|95.0|-3.9|3.6|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||3.6|-3.9|
73852556|NCT03823287|147253067|OTHER||Difference in CMH Weighted Percentage|3.0|||||TWO_SIDED|95.0|-3.6|9.5|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters or achieving BCVA ≥84 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||9.5|-3.6|
73852557|NCT03823287|147253069|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-7.7|6.6|||||The treatment difference in CMH weighted percentage of participants achieving BCVA ≥69 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||6.6|-7.7|
73852558|NCT03823287|147253071|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-4.2|3.3|||||The treatment difference in CMH weighted percentage of participants with BCVA ≤38 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||3.3|-4.2|
73852559|NCT03823287|147253079|OTHER||Adjusted mean difference|-7.4|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-15.7|0.8|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 40-48||0.8|-15.7|
73852560|NCT03823287|147253080|OTHER||Adjusted mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.26|||TWO_SIDED|95.0|-7.4|9.4|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||9.4|-7.4|
73852561|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-3.62|-1.22||||||Day 8 Cohort A: TIP, Pooled PBO||-1.22|-3.62|
73852562|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-3.3|-0.98||||||Day 8 Cohort A: TIP/PBO, Pooled PBO||-0.98|-3.30|
73852563|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-3.2|-0.68||||||Day 8 Cohort B: TIP, Pooled PBO||-0.68|-3.20|
73852564|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.3|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-4.38|-2.15||||||Day 8 Cohort B: TIP/PBO, Pooled PBO|LS Mean Diff (SE) vs pooled placebo|-2.15|-4.38|
73852565|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-4.0|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-5.06|-2.88||||||Day 8 Cohort C: TIP, Pooled PBO||-2.88|-5.06|
73852566|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.4|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.57|-2.14||||||Day 8 Cohort C: TIP/PBO, Pooled PBO||-2.14|-4.57|
73852567|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-3.66|-1.89||||||Day 8: Pooled TIP, Pooled PBO||-1.89|-3.66|
73852568|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.9|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-3.79|-2.05||||||Day 8: Pooled TIP/PBO, Pooled PBO||-2.05|-3.79|
73852569|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-4.28|-1.31||||||Day 29 Cohort A: TIP, Pooled PBO||-1.31|-4.28|
73852570|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-4.03|-0.67||||||Day 29 Cohort A: TIP/PBO, Pooled PBO||-0.67|-4.03|
73852571|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.3|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-4.04|-0.52||||||Day 29 Cohort B: TIP, Pooled PBO||-0.52|-4.04|
74024569|NCT00389207|147601507|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.025||||0.584||95.0|-0.065|0.115||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||0.115|-0.065|0.584
73852572|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.5|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-5.16|-1.85||||||Day 29 Cohort B: TIP/PBO, Pooled PBO||-1.85|-5.16|
73852573|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-4.6|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-6.13|-3.09||||||Day 29 Cohort C: TIP, Pooled PBO||-3.09|-6.13|
73852574|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.1|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|95.0|-4.68|-1.52||||||Day 29 Cohort C: TIP/PBO, Pooled PBO||-1.52|-4.68|
73852575|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.2|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.43|-2.02||||||Day 29: Pooled TIP, Pooled PBO||-2.02|-4.43|
73852576|NCT02712983|147253102|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.0|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.19|-1.78||||||Day 29: Pooled TIP/PBO, Pooled PBO||-1.78|-4.19|
73852577|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-3.82|-0.36||||||Day 57 Cohort A: TIP, Pooled PBO||-0.36|-3.82|
73852578|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-2.21|1.29||||||Day 57 Cohort A: TIP/PBO, Pooled PBO||1.29|-2.21|
73852579|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.87|0.08||||||Day 57 Cohort B: TIP, Pooled PBO||0.08|-3.87|
73852580|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-3.34|0.16||||||Day 57 Cohort B: TIP/PBO, Pooled PBO||0.16|-3.34|
73852581|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.9|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-5.5|-2.22||||||Day 57 Cohort C: TIP, Pooled PBO||-2.22|-5.50|
73852582|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-3.26|0.41||||||Day 57 Cohort C: TIP/PBO, Pooled PBO||0.41|-3.26|
73852583|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-3.98|-1.25||||||Day 57: Pooled TIP, Pooled PBO||-1.25|-3.98|
73852584|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.2|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.5|0.19||||||Day 57: Pooled TIP/PBO, Pooled PBO||0.19|-2.50|
73852585|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.2|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-4.0|-0.38||||||Day 85 Cohort A: TIP, Pooled PBO||-0.38|-4.00|
73852586|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.81|0.13||||||Day 85 Cohort A: TIP/PBO, Pooled PBO||0.13|-3.81|
73852587|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.7|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-4.96|-0.53||||||Day 85 Cohort B: TIP, Pooled PBO||-0.53|-4.96|
73852588|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.6|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-5.44|-1.73||||||Day 85 Cohort B: TIP/PBO, Pooled PBO||-1.73|-5.44|
73852589|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-4.9|-1.07||||||Day 85 Cohort C: TIP, Pooled PBO||-1.07|-4.90|
73852590|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.66|-0.53||||||Day 85 Cohort C: TIP/PBO, Pooled PBO||-0.53|-4.66|
73852591|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-4.11|-1.17||||||Day 85: Pooled TIP, Pooled PBO||-1.17|-4.11|
73852592|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.7|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|-4.12|-1.23||||||Day 85: Pooled TIP/PBO, Pooled PBO||-1.23|-4.12|
73852593|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-4.55|-1.08||||||Day 113 Cohort A: TIP, Pooled PBO||-1.08|-4.55|
73852594|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|0.1|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-1.61|1.71||||||Day 113 Cohort A: TIP/PBO, Pooled PBO||1.71|-1.61|
73852595|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-4.93|-0.29||||||Day 113 Cohort B: TIP, Pooled PBO||-0.29|-4.93|
73852596|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-3.62|-0.25||||||Day 113 Cohort B: TIP/PBO, Pooled PBO||-0.25|-3.62|
73852597|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.1|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-4.94|-1.3||||||Day 113 Cohort C: TIP, Pooled PBO||-1.30|-4.94|
73852598|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-4.37|-0.43||||||Day 113 Cohort C: TIP/PBO, Pooled PBO||-0.43|-4.37|
73852599|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-4.24|-1.45||||||Day 113: Pooled TIP, Pooled PBO||-1.45|-4.24|
73852600|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-2.73|-0.13||||||Day 113: Pooled TIP/PBO, Pooled PBO||-0.13|-2.73|
73852601|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.2|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.64|-0.73||||||EoT Cohort A: TIP, Pooled PBO||-0.73|-3.64|
73852602|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.1|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.61|1.43||||||EoT Cohort A: TIP/PBO, Pooled PBO||1.43|-1.61|
73852603|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.3|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.81|0.25||||||EoT Cohort B: TIP, Pooled PBO||0.25|-2.81|
73852604|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.14|-0.22||||||EoT Cohort B: TIP/PBO, Pooled PBO||-0.22|-3.14|
73852605|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.89|-0.98||||||EoT Cohort C: TIP, Pooled PBO||-0.98|-3.89|
73852606|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.12|-0.22||||||EoT Cohort C: TIP/PBO, Pooled PBO||-0.22|-3.12|
73852607|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.0|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-3.08|-0.85||||||EoT: Pooled TIP, Pooled PBO||-0.85|-3.08|
74084875|NCT04284553|147723129|SUPERIORITY||Mean Difference (Final Values)|1.78|||||TWO_SIDED|95.0|-17.6|21.2|||||"The estimate compares having open encounter as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having open encounter in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||21.2|-17.6|
74024570|NCT00389207|147601507|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.009||||0.855||95.0|-0.084|0.101||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||0.101|-0.084|0.855
74024571|NCT00389207|147601508|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.038||||0.321||95.0|-0.112|0.037||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD patients and N=193 ATZ/r patients.||||0.037|-0.112|0.321
74084876|NCT04284553|147723129|SUPERIORITY||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-41.8|17.5|||||"The estimate compares having boostering as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having boostering in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||17.5|-41.8|
73852608|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.25|-0.04||||||EoT: Pooled TIP/PBO, Pooled PBO||-0.04|-2.25|
73852609|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.8|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-2.63|0.99||||||Day 141 Cohort A: TIP, Pooled PBO||0.99|-2.63|
73852610|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|0.1|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-1.83|1.98||||||Day 141 Cohort A: TIP/PBO, Pooled PBO||1.98|-1.83|
73852611|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|0.2|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-2.03|2.41||||||Day 141 Cohort B: TIP, Pooled PBO||2.41|-2.03|
73852612|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-3.68|-0.01||||||Day 141 Cohort B: TIP/PBO, Pooled PBO||-0.01|-3.68|
73902796|NCT05803603|147335847|SUPERIORITY||Odds Ratio (OR)|2.0||||0.125|TWO_SIDED|95.0|0.37|10.92|||McNemar|||We recruited 8 homeless individuals and followed them for 12 months. 4 individuals (50%) were housed at 6 months and 3 (37.5) were housed at 12 months.|See results above|10.92|.37|.125
74024572|NCT00389207|147601519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.461||||0.0403||95.0|0.22|0.966|||Regression, Cox|||||0.966|0.220|0.0403
73852613|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.9|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-2.78|1.07||||||Day 141 Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||1.07|-2.78|
73852614|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.2|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-3.36|0.89||||||Day 141 Cohort C: TIP/PBO, Pooled PBO||0.89|-3.36|
73852615|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-1.97|0.98||||||Day 141: Pooled TIP, Pooled PBO||0.98|-1.97|
73852616|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-2.45|0.45||||||Day 141: Pooled TIP/PBO, Pooled PBO||0.45|-2.45|
73852617|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.3|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-3.24|0.61||||||Day 169 Cohort A: TIP, Pooled PBO||0.61|-3.24|
73852618|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.05|0.91||||||Day 169 Cohort A: TIP/PBO, Pooled PBO||0.91|-3.05|
73852619|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.6|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-2.73|1.62||||||Day 169 Cohort B: TIP, Pooled PBO||1.62|-2.73|
73852620|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.22|-0.08||||||Day 169 Cohort B: TIP/PBO, Pooled PBO||-0.08|-4.22|
73852621|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.2|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-2.48|2.1||||||Day 169 Cohort C: TIP, Pooled PBO||2.10|-2.48|
73852622|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.1|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-2.33|2.13||||||Day 169 Cohort C: TIP/PBO, Pooled PBO||2.13|-2.33|
73852623|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.7|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.24|0.86||||||Day 169: Pooled TIP, Pooled PBO||0.86|-2.24|
73902797|NCT05128929|147335848|SUPERIORITY||Mean Difference (Final Values)|0.614||||0.541|TWO_SIDED|95.0|-1.47|2.79|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||"Null: There is no significant difference in the mean primary endpoint (PVR) at 24 weeks between the treatment (H01) and placebo group.~The following analysis utilizes PVR determined by TD."||2.79|-1.47|0.541
73902798|NCT05128929|147335850|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.599|TWO_SIDED|95.0|-4.34|7.27|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (mPAP) at 24 weeks between the treatment (H01) and placebo group.||7.27|-4.34|0.599
73902799|NCT05128929|147335851|SUPERIORITY||Mean Difference (Final Values)|47.26||||0.166|TWO_SIDED|95.0|-21.43|115.95|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (6MWT distance) at 24 weeks between the treatment (H01) and placebo group.||115.95|-21.43|0.166
73902800|NCT05128929|147335852|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.975|TWO_SIDED|95.0|-8.22|7.98|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (emPHasis-10 score) at 24 weeks between the treatment (H01) and placebo group.||7.98|-8.22|0.975
73902801|NCT05128929|147335853|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.086|TWO_SIDED|95.0|-19.4|1.4|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (SGRQ Score) at 24 weeks between the treatment (H01) and placebo group.||1.4|-19.40|0.086
73902802|NCT05128929|147335854|SUPERIORITY||Mean Difference (Final Values)|73.92||||0.215|TWO_SIDED|95.0|-45.61|193.46|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (serum HA) at 24 weeks between the treatment (H01) and placebo group.||193.46|-45.61|0.215
73902803|NCT05128929|147335855|SUPERIORITY||Mean Difference (Final Values)|231.47||||0.442|TWO_SIDED|95.0|-377.26|840.2|||Mixed Models Analysis|||There is no significant difference in the mean secondary endpoint (NT-proBNP) at 24 weeks between the treatment (H01) and placebo group.||840.20|-377.26|0.442
73902804|NCT02742246|147335865|SUPERIORITY|||||||0.11||||||Group by Time interaction.|Regression, Linear|||||||0.11
73902805|NCT02742246|147335866|SUPERIORITY|||||||0.14||||||Group by time interaction.|Regression, Linear|||||||0.14
73902806|NCT03553836|147335872|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.00046|TWO_SIDED|95.0|0.45|0.82||One-sided p-value based on log-rank test stratified by melanoma T Stage (T3b, T4a, T4b).|Log Rank||Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma T Stage (T3b, T4a, T4b).|||0.82|0.45|0.00046
73902807|NCT03553836|147335875|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|4.1|||||TWO_SIDED|95.0|1.0|7.3||||||||7.3|1.0|
73902808|NCT03553836|147335876|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|12.9|||||TWO_SIDED|95.0|9.1|16.9||||||||16.9|9.1|
73902809|NCT01850602|147335909|NON_INFERIORITY|"Non-Inferiority margin: 1.0 mg/dL~Non-Inferiority was considerd to be confirmed if the upper limit of two-sided confidence interval became 1.0 mg/dL or less."|Mean Difference (Final Values)|-0.34||||0.02|TWO_SIDED|95.0|-0.63|-0.05|||ANCOVA|||||-0.05|-0.63|0.020
73852624|NCT02712983|147253103|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.61|0.4||||||Day 169: Pooled TIP/PBO, Pooled PBO||0.40|-2.61|
73852625|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.14|3.18|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP, Pooled PBO||3.18|0.14|
73852626|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.18|1.85|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP/PBO, Pooled PBO||1.85|0.18|
73852627|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.42|3.77|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP, Pooled PBO||3.77|0.42|
73902810|NCT01155479|147335916|SUPERIORITY_OR_OTHER||Difference in Estimated Means|2.6||||0.0033|TWO_SIDED|95.0|0.86|4.3|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||4.30|0.86|0.0033
74024573|NCT00389207|147601523|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.097||||0.0109||95.0|-0.171|-0.022||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients||||-0.022|-0.171|0.0109
74024574|NCT00389207|147601523|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.072||||0.1033||95.0|-0.158|0.015||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||0.015|-0.158|0.1033
73902811|NCT01155479|147335916|SUPERIORITY_OR_OTHER||Difference in Estimated Means|1.3||||0.1382|TWO_SIDED|95.0|-0.41|2.94|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||2.94|-0.41|0.1382
74088271|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-4.28|STANDARD_ERROR_OF_MEAN|4.37||0.3302|TWO_SIDED|95.0|-12.97|4.41|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.41|-12.97|0.3302
73852628|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.2|1.83|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP/PBO, Pooled PBO||1.83|0.20|
73852629|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.21|2.17|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP, Pooled PBO||2.17|0.21|
73852630|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.44|3.62|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP/PBO, Pooled PBO||3.62|0.44|
73852631|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.44|2.23|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP, Pooled PBO||2.23|0.44|
73852632|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.34|1.71|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP/PBO, Pooled PBO||1.71|0.34|
73852633|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.08|1.83|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP, Pooled PBO||1.83|0.08|
73852634|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.25|2.89|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP/PBO, Pooled PBO||2.89|0.25|
73852635|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.25|3.93|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP, Pooled PBO||3.93|0.25|
73852636|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.19|2.36|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP/PBO, Pooled PBO||2.36|0.19|
73852637|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.19|||||TWO_SIDED|95.0|0.02|1.57|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP, Pooled PBO||1.57|0.02|
73852638|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.16|2.41|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP/PBO, Pooled PBO||2.41|0.16|
73852639|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.13|1.31|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP, Pooled PBO||1.31|0.13|
73852640|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.28|1.8|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP/PBO, Pooled PBO||1.80|0.28|
73852641|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|10.71|||||TWO_SIDED|95.0|1.1|104.19|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort A: TIP, Pooled PBO||104.19|1.10|
73852642|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|4.62|||||TWO_SIDED|95.0|0.41|52.29|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP, Pooled PBO||52.29|0.41|
73852643|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|3.23|||||TWO_SIDED|95.0|0.28|37.06|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP/PBO, Pooled PBO||37.06|0.28|
73852644|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|1.61|||||TWO_SIDED|95.0|0.1|25.94|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP, Pooled PBO||25.94|0.10|
73902812|NCT01155479|147335916|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.4||||0.6378|TWO_SIDED|95.0|-1.29|2.11|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||2.11|-1.29|0.6378
73902813|NCT01155479|147335916|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.3||||0.6923|TWO_SIDED|95.0|-1.35|2.03|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)||2.03|-1.35|0.6923
73902814|NCT01155479|147335917|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-9.7||||0.0785|TWO_SIDED|95.0|-21.0|1.82||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||1.82|-21.0|0.0785
73902815|NCT01155479|147335917|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-6.3||||0.2735|TWO_SIDED|95.0|-17.6|5.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||5.05|-17.6|0.2735
73902816|NCT01155479|147335917|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-3.7||||0.4823|TWO_SIDED|95.0|-15.2|7.99||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||7.99|-15.2|0.4823
73902817|NCT01155479|147335917|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-2.3||||0.6827|TWO_SIDED|95.0|-13.9|9.24||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Rasagiline (Part 1) vs Placebo (Part 1)||9.24|-13.9|0.6827
73902818|NCT01155479|147335918|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.7||||0.0235|TWO_SIDED|95.0|0.09|1.27|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||1.27|0.09|0.0235
73902819|NCT01155479|147335918|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.5||||0.1093|TWO_SIDED|95.0|-0.11|1.04|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||1.04|-0.11|0.1093
74024575|NCT00389207|147601523|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.122||||0.0073||95.0|-0.212|-0.033||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||-0.033|-0.212|0.0073
73902820|NCT01155479|147335918|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.2||||0.5756|TWO_SIDED|95.0|-0.42|0.75|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||0.75|-0.42|0.5756
73902821|NCT01155479|147335918|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.6657|TWO_SIDED|95.0|-0.45|0.7|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)||0.70|-0.45|0.6657
73902822|NCT01101191|147335962|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|103.0|||||TWO_SIDED|90.0|98.67|106.66|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||106.66|98.67|
74024576|NCT00389207|147601524|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.117||||0.0031||95.0|-0.194|-0.04||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients.||||-0.040|-0.194|0.0031
73902823|NCT01101191|147335963|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.0|||||TWO_SIDED|90.0|94.2|99.81|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||99.81|94.20|
73902824|NCT01101191|147335964|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.1|||||TWO_SIDED|90.0|94.41|99.94|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||99.94|94.41|
73902825|NCT03687970|147335983|OTHER|Multivariable logistic regression was applied to predict binary outcome while controlling for other potential confounding factors (age, cumulative chemotherapy dose, chemotherapy group).|Slope|-0.13||||0.05|TWO_SIDED|||||threshold for p value is 0.05.|Regression, Logistic|||||||0.05
73902826|NCT03687970|147335984|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|0.22||||0.7525|TWO_SIDED|||||The thrshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.7525
73902827|NCT03687970|147335984|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for Control group patients without painful CIPN was calculated.|rho coefficient|0.32||||0.1876|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficien|||||||0.1876
73902828|NCT03687970|147335984|OTHER|Spearman correlation coefficient between the Aδ:C fiber pain threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|0.13||||0.61|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.61
73902829|NCT03687970|147335984|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|-0.2812205||||0.2914|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.2914
73902830|NCT04030026|147336007|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.208|0.431||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.431|0.208|< 0.0001
73962112|NCT00232180|147460778|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.577|||<|0.0001|TWO_SIDED|95.0|0.475|0.701||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.701|0.475|<0.0001
73902831|NCT04030026|147336009|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.208|0.431||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.431|0.208|<0.0001
73902832|NCT04030026|147336010|SUPERIORITY||Geometric Mean Ratio|0.47||||0.0087|TWO_SIDED|95.0|0.23|0.717||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.717|0.230|0.0087
73902833|NCT04030026|147336011|SUPERIORITY|||||||0.0014||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0014
73902834|NCT04030026|147336011|SUPERIORITY|||||||0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 16||||0.0001
73902835|NCT04030026|147336011|SUPERIORITY|||||||0.001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.001
73902836|NCT04030026|147336012|SUPERIORITY|||||||0.0198||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0198
73902837|NCT04030026|147336012|SUPERIORITY|||||||0.0374||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 16||||0.0374
73902838|NCT04030026|147336012|SUPERIORITY|||||||0.2982||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.2982
73902839|NCT04030026|147336013|SUPERIORITY|||||||0.0054||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo)|Student's T-test|||Change from baseline at Day 8||||0.0054
73902840|NCT04030026|147336013|SUPERIORITY||||||<|0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 15||||<0.0001
73902841|NCT04030026|147336013|SUPERIORITY|||||||0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 21||||0.0001
74024577|NCT00389207|147601524|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.096||||0.0365||95.0|-0.186|-0.006||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||-0.006|-0.186|0.0365
73902842|NCT04030026|147336014|SUPERIORITY|||||||0.0107||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0107
73902843|NCT04030026|147336014|SUPERIORITY|||||||0.0051||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change for baseline at Day 16||||0.0051
73902844|NCT04030026|147336014|SUPERIORITY|||||||0.1513||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.1513
73902845|NCT04030026|147336015|SUPERIORITY|||||||0.3601||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||||||0.3601
73902846|NCT04480424|147336019|SUPERIORITY||Risk Difference|-4.0||||0.8275|TWO_SIDED|95.0|-22.3|14.5||p-value was calculated using Fisher's exact method with 5% level of significance to test the null hypothesis of no difference in mortality rate between the two treatment groups.|Fisher Exact|||||14.5|-22.3|0.8275
73902847|NCT04480424|147336020|SUPERIORITY|||||||0.8599||||||p-value was calculated using Gray's test for equality of the Cumulative Incidence Function (CIF) between treatment groups.|Gray's test|||||||0.8599
73902848|NCT04480424|147336021|SUPERIORITY||Least Square Mean (LSM) Difference|2.58||||0.2626|TWO_SIDED|95.0|-1.96|7.12||p-value was calculated using an Analysis of Variance (ANOVA) model, including the number of days on mechanical ventilation as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.12|-1.96|0.2626
73902849|NCT04480424|147336022|SUPERIORITY|||||||0.6854||||||p-value was calculated using Gray's test for equality of the CIF between treatment groups.|Gray's test|||||||0.6854
73902850|NCT04480424|147336023|SUPERIORITY||LSM Difference|-0.02||||0.9917|TWO_SIDED|95.0|-3.82|3.78||95% CI for difference in least square mean (LSM) between treatment groups and the associated p-value were calculated using an ANOVA model, including the number of days on oxygen as a dependent variable and treatment group as a fixed effect.|ANOVA|||||3.78|-3.82|0.9917
74024578|NCT00389207|147601524|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.139||||0.0033||95.0|-0.231|-0.046||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||-0.046|-0.231|0.0033
74024579|NCT00389207|147601527|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.001||||0.9784|TWO_SIDED|95.0|-0.065|0.066|||Cochran Chi-Squared|||week 48||0.066|-0.065|0.9784
73902851|NCT04480424|147336024|SUPERIORITY||LSM Difference|0.05||||0.7557|TWO_SIDED|95.0|-0.29|0.4|||Kenward-Roger|p-value were calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.||||0.40|-0.29|0.7557
73902852|NCT04480424|147336025|SUPERIORITY||LSM Difference|0.4||||0.0922|TWO_SIDED|95.0|-0.07|0.86||p-value were calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||||0.86|-0.07|0.0922
73902853|NCT04480424|147336029|SUPERIORITY||Kenward-Roger|0.4||||0.3611|TWO_SIDED|95.0|-0.47|1.28||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.28|-0.47|0.3611
73902854|NCT04480424|147336029|SUPERIORITY||Kenward-Roger|-0.1||||0.9238|TWO_SIDED|95.0|-2.13|1.94||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.94|-2.13|0.9238
73902855|NCT04480424|147336029|SUPERIORITY||Kenward-Roger|0.08||||0.9541|TWO_SIDED|95.0|-2.58|2.73||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||2.73|-2.58|0.9541
74024580|NCT00389207|147601527|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.064||||0.0331|TWO_SIDED|95.0|0.005|0.123|||Cochran Chi-Squared|||week 96||0.123|0.005|0.0331
73852645|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|11.3|||||TWO_SIDED|95.0|1.09|117.34|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP/PBO, Pooled PBO||117.34|1.09|
73852646|NCT02712983|147253104|OTHER||Hazard Ratio (HR)|4.3|||||TWO_SIDED|95.0|0.5|37.32|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Pooled TIP, Pooled PBO||37.32|0.50|
73852647|NCT02712983|147253105|OTHER||LS Mean Diff (SE) vs pooled placebo|9.8|STANDARD_ERROR_OF_MEAN|18.15|||TWO_SIDED|95.0|-27.15|46.81|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort A: TIP, Pooled PBO||46.81|-27.15|
73852648|NCT02712983|147253105|OTHER||LS Mean Diff (SE) vs pooled placebo|19.8|STANDARD_ERROR_OF_MEAN|20.81|||TWO_SIDED|95.0|-22.63|62.14|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort A: TIP/PBO, Pooled PBO||62.14|-22.63|
73852649|NCT02712983|147253105|OTHER||LS Mean Diff (SE) vs pooled placebo|8.0|STANDARD_ERROR_OF_MEAN|19.29|||TWO_SIDED|95.0|-31.32|47.26|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort B: TIP, Pooled PBO||47.26|-31.32|
73852650|NCT02712983|147253105|OTHER||LS Mean Diff (SE) vs pooled placebo|12.7|STANDARD_ERROR_OF_MEAN|19.24|||TWO_SIDED|95.0|-26.49|51.89|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort B: TIP/PBO, Pooled PBO||51.89|-26.49|
73852651|NCT02712983|147253105|OTHER||LS Mean Diff (SE) vs pooled placebo|46.5|STANDARD_ERROR_OF_MEAN|21.17|||TWO_SIDED|95.0|3.37|89.61|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort C: TIP, Pooled PBO||89.61|3.37|
73902856|NCT04480424|147336030|SUPERIORITY||LSM Difference|0.06||||0.9366|TWO_SIDED|95.0|-1.42|1.53||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.53|-1.42|0.9366
73902857|NCT00403403|147336051|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528||||0.0097||95.0|0.323|0.862|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||0.862|0.323|0.0097
73902858|NCT00403403|147336052|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.6054|TWO_SIDED|95.0|0.66|2.039|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||2.039|0.660|0.6054
73902859|NCT00403403|147336053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.3269||95.0|-9.6|29.0|||Chi-squared|||||29.0|-9.6|0.3269
73902860|NCT00403403|147336055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.305||||0.0011|TWO_SIDED|95.0|0.144|0.644|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||0.644|0.144|0.0011
74024581|NCT00389207|147601527|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.058||||0.0691|TWO_SIDED|95.0|-0.005|0.121|||Cochran Chi-Squared|||week 144||0.121|-0.005|0.0691
73852652|NCT02712983|147253105|OTHER||LS Mean Diff (SE) vs pooled placebo|3.2|STANDARD_ERROR_OF_MEAN|18.37|||TWO_SIDED|95.0|-34.21|40.64|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort C: TIP/PBO, Pooled PBO||40.64|-34.21|
73852653|NCT02712983|147253105|OTHER||LS Mean Diff (SE) vs pooled placebo|21.4|STANDARD_ERROR_OF_MEAN|14.46|||TWO_SIDED|95.0|-8.03|50.89|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Pooled TIP, Pooled PBO||50.89|-8.03|
73852654|NCT02712983|147253105|OTHER||LS Mean Diff (SE) vs pooled placebo|11.9|STANDARD_ERROR_OF_MEAN|14.44|||TWO_SIDED|95.0|-17.52|41.29|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Pooled TIP/PBO, Pooled PBO||41.29|-17.52|
73852655|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.51|3.13|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP, Pooled PBO||3.13|0.51|
73852656|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.15|1.46|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP/PBO, Pooled PBO||1.46|0.15|
73962113|NCT00232180|147460779|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.694|||<|0.0001|TWO_SIDED|95.0|0.598|0.806||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.806|0.598|<0.0001
73962114|NCT00232180|147460780|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.316||||0.2321|TWO_SIDED|95.0|0.839|2.064||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||2.064|0.839|0.2321
73962115|NCT00232180|147460781|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.789||||0.4213|TWO_SIDED|95.0|0.443|1.406||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.406|0.443|0.4213
73962116|NCT00232180|147460782|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.994||||0.9754|TWO_SIDED|95.0|0.694|1.424||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.424|0.694|0.9754
73962117|NCT00232180|147460783|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.2652|TWO_SIDED|95.0|0.485|1.22||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.220|0.485|0.2652
73962118|NCT00232180|147460784|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.971||||0.9537|TWO_SIDED|95.0|0.366|2.578||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||2.578|0.366|0.9537
73962119|NCT00232180|147460785|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.154||||0.8539|TWO_SIDED|95.0|0.251|5.312||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||5.312|0.251|0.8539
73962120|NCT00232180|147460786|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.585||||0.0175|TWO_SIDED|95.0|0.376|0.91||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.910|0.376|0.0175
73962121|NCT00232180|147460787|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.885||||0.6009|TWO_SIDED|95.0|0.559|1.4||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.400|0.559|0.6009
73962122|NCT03538717|147460793|SUPERIORITY|||||||0.113|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.113
73962123|NCT03538717|147460794|SUPERIORITY|||||||0.228|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.228
73962124|NCT03538717|147460795|SUPERIORITY|||||||0.02|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.020
73962125|NCT03538717|147460796|SUPERIORITY|||||||0.138|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.138
73962126|NCT03538717|147460797|SUPERIORITY|||||||0.524|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.524
73962127|NCT03538717|147460798|SUPERIORITY|||||||0.265|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.265
73962128|NCT03538717|147460799|SUPERIORITY|||||||0.035|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.035
73962129|NCT03538717|147460800|SUPERIORITY|||||||0.123|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.123
73962130|NCT03538717|147460801|SUPERIORITY|||||||0.327|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.327
73962131|NCT03538717|147460802|SUPERIORITY|||||||0.419|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.419
73962132|NCT03538717|147460803|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.010
73962133|NCT03538717|147460804|SUPERIORITY|||||||0.446|||||||Chi-squared|||100% clear cells||||0.446
73962134|NCT03538717|147460804|SUPERIORITY|||||||0.596|||||||Chi-squared|||100% non-clear cells||||0.596
73962135|NCT03538717|147460804|SUPERIORITY|||||||0.578|||||||Chi-squared|||Majority component of clear cells||||0.578
73962136|NCT03538717|147460804|SUPERIORITY|||||||0.706|||||||Fisher Exact|||Majority component of non-clear cells||||0.706
73962137|NCT03538717|147460805|SUPERIORITY|||||||0.074|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.074
73962138|NCT03538717|147460806|SUPERIORITY|||||||0.07|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.070
73962139|NCT03538717|147460807|SUPERIORITY|||||||0.091|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.091
73962140|NCT03538717|147460808|SUPERIORITY|||||||0.046|||||||Chi-squared|||Lymph nodes||||0.046
74024582|NCT00389207|147601527|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|-0.023||||0.4585|TWO_SIDED|95.0|-0.084|0.038|||Cochran Chi-Squared|||week 48||0.038|-0.084|0.4585
73852657|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.44|3.21|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP, Pooled PBO||3.21|0.44|
73962141|NCT03538717|147460808|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||CNS||||>0.999
73962142|NCT03538717|147460808|SUPERIORITY|||||||0.026|||||||Chi-squared|||Hepatic||||0.026
73962143|NCT03538717|147460808|SUPERIORITY|||||||0.327|||||||Chi-squared|||Pulmonary||||0.327
73962144|NCT03538717|147460808|SUPERIORITY|||||||0.024|||||||Chi-squared|||Bone||||0.024
73962145|NCT03538717|147460808|SUPERIORITY|||||||0.045|||||||Chi-squared|||Another site of metastasis||||0.045
73962146|NCT03538717|147460809|SUPERIORITY|||||||0.555|||||||Chi-squared|||LDH level \>1.5\*ULN||||0.555
73962147|NCT03538717|147460809|SUPERIORITY||||||<|0.001|||||||Chi-squared|||Hgb levels \<=LLN||||<0.001
73962148|NCT03538717|147460809|SUPERIORITY|||||||0.344|||||||Chi-squared|||Corrected Ca levels \>10 mg/dL||||0.344
73962149|NCT03538717|147460809|SUPERIORITY||||||>|0.999|||||||Chi-squared|||Neutrophil levels \>ULN||||>0.999
73962150|NCT03538717|147460809|SUPERIORITY|||||||0.795|||||||Chi-squared|||Platelet levels \>ULN||||0.795
73962151|NCT03538717|147460809|SUPERIORITY|||||||0.184|||||||Chi-squared|||Neutrophil-to-lymphocyte ratio \<=3||||0.184
74024583|NCT00389207|147601527|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.015||||0.5438|TWO_SIDED|95.0|-0.034|0.064|||Cochran Chi-Squared|||week 96||0.064|-0.034|0.5438
73852658|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.32|2.18|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP/PBO, Pooled PBO||2.18|0.32|
73852659|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.1|1.27|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP, Pooled PBO||1.27|0.10|
73852660|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.43|2.99|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP/PBO, Pooled PBO||2.99|0.43|
73852661|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.37|1.76|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP, Pooled PBO||1.76|0.37|
73852662|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.36|1.61|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP/PBO, Pooled PBO||1.61|0.36|
73852663|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.3|2.55|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP, Pooled PBO||2.55|0.30|
73852664|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.2|2.03|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP/PBO, Pooled PBO||2.03|0.20|
73852665|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.4|3.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP, Pooled PBO||3.60|0.40|
73852666|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.31|2.55|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP/PBO, Pooled PBO||2.55|0.31|
73852667|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.06|1.27|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP, Pooled PBO||1.27|0.06|
73852668|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.45|3.73|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP/PBO, Pooled PBO||3.73|0.45|
73902861|NCT00472459|147336078|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.514||||0.012|TWO_SIDED|95.0|0.116|0.911|||t-test, 2 sided||The 95 % confidence intervals for the lesion complete response rates and lesion recurrence rates were estimated using the method of Clopper and Pearson.|||0.911|0.116|0.0120
73902862|NCT00472459|147336079|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.413||||0.1761|TWO_SIDED|95.0|-0.19|1.016|||t-test, 2 sided|||||1.016|-0.190|0.1761
73902863|NCT00472459|147336080|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.6||||0.1183|TWO_SIDED|95.0|-0.156|1.357|||t-test, 2 sided|||||1.357|-0.156|0.1183
73902864|NCT00472459|147336081|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.493||||0.2322|TWO_SIDED|95.0|-0.323|1.309|||t-test, 2 sided|||||1.309|-0.323|0.2322
73902865|NCT00472459|147336082|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.68||||0.1286|TWO_SIDED|95.0|-0.202|1.562|||t-test, 2 sided|||||1.562|-0.202|0.1286
73902866|NCT02284178|147336207|SUPERIORITY|||||||0.432|||||||GEE analysis|||||||0.432
73902867|NCT02284178|147336208|SUPERIORITY|||||||0.684|||||||GEE|||||||0.684
73902868|NCT02284178|147336209|SUPERIORITY|||||||0.858|||||||Chi-squared|||||||0.858
73902869|NCT02284178|147336211|SUPERIORITY|||||||0.46|||||||GEE analysis|||||||0.460
73902870|NCT02284178|147336212|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||||||0.214
73902871|NCT02284178|147336213|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
73902872|NCT02284178|147336214|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.050
73902873|NCT00478881|147336237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.045||||0.5293||95.0|-33.194|17.104||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P\<0.05.|ANCOVA||Placebo-Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.||17.104|-33.194|0.5293
73902874|NCT00478881|147336238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.668||||0.0575||95.0|-0.021|1.358||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P \<0.05.|ANCOVA||Placebo - Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.||1.358|-0.021|0.0575
73902875|NCT00478881|147336239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.657||||0.8533||95.0|-6.335|7.65||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||7.650|-6.335|0.8533
73902876|NCT00478881|147336240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.59||||0.1539||95.0|-37.057|5.876||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||5.876|-37.057|0.1539
73902877|NCT00478881|147336241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.374||||0.2348||95.0|-32.834|8.087||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||8.087|-32.834|0.2348
73902878|NCT00478881|147336242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.195||||0.3289||95.0|-24.692|8.303||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||8.303|-24.692|0.3289
73902879|NCT00478881|147336243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.721||||0.0609||95.0|-0.033|1.476||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||1.476|-0.033|0.0609
73902880|NCT00478881|147336244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118||||0.4928||95.0|-0.22|0.456||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||0.456|-0.220|0.4928
73902881|NCT00478881|147336245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.823||||0.3248||95.0|-2.476|0.829||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||0.829|-2.476|0.3248
73902882|NCT00478881|147336246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.095||||0.5312||95.0|-4.533|2.342||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA|||ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||2.342|-4.533|0.5312
73902883|NCT00737464|147336248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|||||TWO_SIDED|||||||||||||
73902884|NCT02397564|147336272|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||0.019
73852669|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.27|1.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP, Pooled PBO||1.60|0.27|
73852670|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.4|2.02|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP/PBO, Pooled PBO||2.02|0.40|
73852671|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|3.72|||||TWO_SIDED|95.0|0.84|16.52|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort A: TIP, Pooled PBO||16.52|0.84|
73852672|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.22|8.16|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP, Pooled PBO||8.16|0.22|
73852673|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|2.15|||||TWO_SIDED|95.0|0.46|10.05|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP/PBO, Pooled PBO||10.05|0.46|
73902885|NCT01041495|147336274|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.869||||0.869|TWO_SIDED|95.0||||P values below 0.05 were considered statistically significant|t-test, 2 sided|||||||.869
73902886|NCT01041495|147336275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0||||0.486|TWO_SIDED||||||t-test, 2 sided|||Visual Analogue Pain Scale (VAPS). The final visit VAPS at 8th week will be compared against baseline VAPS scores for both treatment groups||||.486
73852674|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.05|4.87|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP, Pooled PBO||4.87|0.05|
73852675|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|2.56|||||TWO_SIDED|95.0|0.53|12.49|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP/PBO, Pooled PBO||12.49|0.53|
73852676|NCT02712983|147253110|OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.33|5.68|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Paremteral Pooled TIP, Pooled PBO||5.68|0.33|
73852677|NCT02712983|147253115|OTHER||Odds Ratio, log|5.62|||||TWO_SIDED|95.0|0.83|38.18|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort A (3 capsules o.d.): TIP, Pooled PBO||38.18|0.83|
73852678|NCT02712983|147253115|OTHER||Odds Ratio, log|2.0|||||TWO_SIDED|95.0|0.21|19.16|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort B (5 capsules o.d.): TIP, Pooled PBO||19.16|0.21|
73852679|NCT02712983|147253115|OTHER||Odds Ratio, log|3.05|||||TWO_SIDED|95.0|0.43|21.8|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO||21.80|0.43|
73902887|NCT01041495|147336275|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.486|TWO_SIDED||||||t-test, 1 sided|||||||.486
73852680|NCT02712983|147253115|OTHER||Odds Ratio, log|1.84|||||TWO_SIDED|95.0|0.19|17.42|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||17.42|0.19|
73852681|NCT02712983|147253115|OTHER||Odds Ratio, log|3.41|||||TWO_SIDED|95.0|0.47|25.03|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO||25.03|0.47|
73852682|NCT02712983|147253115|OTHER||Odds Ratio, log|2.74|||||TWO_SIDED|95.0|0.47|16.07|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|||16.07|0.47|
73852683|NCT02712983|147253116|OTHER||Hazard Ratio (HR)|4.5|||||TWO_SIDED|95.0|0.77|26.42|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort A (3 capsules o.d.): TIP, Pooled PBO||26.42|0.77|
73852684|NCT02712983|147253116|OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|95.0|0.28|14.47|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort B (5 capsules o.d.): TIP, Pooled PBO||14.47|0.28|
73852685|NCT02712983|147253116|OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.2|11.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO||11.60|0.20|
73902888|NCT01041495|147336276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.0||||0.869|TWO_SIDED||||||t-test, 2 sided||As above- this was the difference between the groups on mean avg, it was used here|||||.869
73902889|NCT01041495|147336276|SUPERIORITY||Mean Difference (Final Values)|17.0||||0.275|TWO_SIDED||||||t-test, 1 sided|||||||.275
73902890|NCT03584373|147336277|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.14||||0.7|TWO_SIDED|95.0|-0.89|0.6|||t-test, 2 sided|||||0.60|-0.89|0.70
73902891|NCT03584373|147336278|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.23||||0.58|TWO_SIDED|95.0|-1.08|0.61|||t-test, 2 sided|||||0.61|-1.08|0.58
73902892|NCT03584373|147336279|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-1.91||||0.006|TWO_SIDED|95.0|-3.25|-0.56|||t-test, 2 sided|||||-0.56|-3.25|0.006
73852686|NCT02712983|147253116|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.06|7.49|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||7.49|0.06|
73852687|NCT02712983|147253116|OTHER||Hazard Ratio (HR)|3.81|||||TWO_SIDED|95.0|0.62|23.29|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO||23.29|0.62|
73852688|NCT02712983|147253116|OTHER||Hazard Ratio (HR)|1.82|||||TWO_SIDED|95.0|0.35|9.45|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Pooled TIP, Pooled PBO||9.45|0.35|
73852689|NCT05360966|147253131|OTHER|Difference (2-sided)|Difference in Percentages|38.8|||<|0.0001|TWO_SIDED|95.0|30.8|46.8||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|46.8|30.8|<0.0001
73852690|NCT05360966|147253132|OTHER|Difference (2-sided)|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.08||0.1321|TWO_SIDED|95.0|-7.2|0.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||0.9|-7.2|0.1321
73852691|NCT05360966|147253133|OTHER|Difference (2-sided)|Least Squares Mean Difference|8.3|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|6.9|9.8||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.8|6.9|<0.0001
73852692|NCT05360966|147253134|OTHER|Difference (2-sided)|Difference in Percentages|40.1|||<|0.0001|TWO_SIDED|95.0|32.3|47.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|47.9|32.3|<0.0001
73852693|NCT05360966|147253135|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|6.3|8.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||8.9|6.3|<0.0001
73902893|NCT03584373|147336280|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-1.16||||0.04|TWO_SIDED|95.0|-2.26|-0.06|||t-test, 2 sided|||||-0.06|-2.26|0.04
73902894|NCT03584373|147336281|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.55||||0.33|TWO_SIDED|95.0|-1.67|0.56|||t-test, 2 sided|||||0.56|-1.67|0.33
73902895|NCT03584373|147336282|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|0.06||||0.47|TWO_SIDED|95.0|-0.1|0.21|||t-test, 2 sided|||||0.21|-0.10|0.47
73902896|NCT03780400|147336298|OTHER|test for within group change from baseline to 4 month follow-up||||||0.5145|||||||t-test, 2 sided|||||||0.5145
73902897|NCT03780400|147336299|OTHER|test for within group change from baseline to 4 month follow-up||||||0.3683|||||||t-test, 2 sided|||||||0.3683
73902898|NCT03780400|147336300|OTHER|test for within group change from baseline to 4 month follow-up||||||0.9858|||||||t-test, 2 sided|||||||0.9858
73902899|NCT03780400|147336301|OTHER|test for within group change from baseline to 4 month follow-up|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73902900|NCT03780400|147336302|OTHER|test for within group change from baseline to 4 month follow-up|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73902901|NCT03977454|147336359|SUPERIORITY||Mean Difference (Net)|1.2||||0.69|TWO_SIDED||||||t-test, 2 sided|||The primary endpoint was a comparison between groups at 24 hours.||||0.69
73852694|NCT05360966|147253136|OTHER|Difference (2 sided)|Difference in Percentages|37.3|||<|0.0001|TWO_SIDED|95.0|28.7|45.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|45.9|28.7|<0.0001
73852695|NCT05360966|147253137|OTHER|Difference (2-sided)|Least Squares Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|6.5|9.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.6|6.5|<0.0001
73852696|NCT05360966|147253138|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|2.4||0.5626|TWO_SIDED|95.0|-6.1|3.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.3|-6.1|0.5626
73852697|NCT05360966|147253139|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.53||0.5981|TWO_SIDED|95.0|-6.3|3.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.6|-6.3|0.5981
73852698|NCT05360966|147253140|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.44||0.5161|TWO_SIDED|95.0|-6.4|3.2||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.2|-6.4|0.5161
73852699|NCT05360966|147253141|OTHER|Difference (2-sided)|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.51||0.8574|TWO_SIDED|95.0|-4.5|5.4||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||5.4|-4.5|0.8574
73852700|NCT05360966|147253142|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|2.69||0.698|TWO_SIDED|95.0|-6.3|4.2||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||4.2|-6.3|0.6980
73902902|NCT03977454|147336360|SUPERIORITY||Mean Difference (Net)|0.1||||0.92|TWO_SIDED||||||t-test, 2 sided|||Scores were compared at 2 days post operation.||||0.92
73902903|NCT03977454|147336361|SUPERIORITY||Mean Difference (Net)|0.5||||0.91|TWO_SIDED||||||t-test, 2 sided|||||||0.91
73902904|NCT03977454|147336363|SUPERIORITY||Mean Difference (Net)|0.0||||0.85|TWO_SIDED||||||t-test, 2 sided|||Scores were compared at 2 weeks.||||0.85
73962152|NCT03538717|147460810|SUPERIORITY|||||||0.235|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.235
73902905|NCT02129777|147336376|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.008||||0.925|TWO_SIDED|95.0|-0.162|0.179|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Cochran-Mantel-Haenszel (CMH) P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.179|-0.162|0.925
73902906|NCT02129777|147336376|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.087||||0.162|TWO_SIDED|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.028|-0.202|0.162
73902907|NCT02129777|147336376|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.034||||0.671|TWO_SIDED|95.0|-0.187|0.118|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.118|-0.187|0.671
73902908|NCT02129777|147336376|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.087||||0.182|TWO_SIDED|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.028|-0.202|0.182
73902909|NCT02129777|147336378|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.75||0.435|TWO_SIDED|95.0|-2.1|4.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||4.9|-2.1|0.435
73902910|NCT02129777|147336378|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|1.74||0.279|TWO_SIDED|95.0|-1.6|5.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||5.4|-1.6|0.279
73902911|NCT02129777|147336378|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.74||0.085|TWO_SIDED|95.0|-0.4|6.5|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||6.5|-0.4|0.085
73962153|NCT04512482|147460831|SUPERIORITY|||||||0.044|||||||ANOVA|||A power analysis determined that a sample size of forty-five (45) subjects would possess 90% power to detect an effect size of 0.5 between the intervention and control legs of the crossover design. With 43 total subjects the study had between 85 and 90% power.||||.044
73962154|NCT03926039|147460898|EQUIVALENCE|Equivalence Analysis||||||0.05|||||||ANOVA|||Both group of average difference (95% CI) in intervention group and control group||||0.05
73962155|NCT02528188|147460932|SUPERIORITY||Risk Difference (RD)|2.39||||0.0123|TWO_SIDED|95.0|0.58|4.68|||Exact methods for risk difference|||||4.68|0.58|0.0123
73962156|NCT02528188|147460932|SUPERIORITY||Risk Difference (RD)|5.61|||<|0.0001|TWO_SIDED|95.0|3.55|8.14|||Exact methods for risk difference|||||8.14|3.55|<0.0001
73962157|NCT02528188|147460933|SUPERIORITY||Rate Difference|23.5||||0.0012|TWO_SIDED|95.0|9.3|37.7|||Poisson model for rate difference|||||37.7|9.3|0.0012
73962158|NCT02528188|147460933|SUPERIORITY||Rate Difference|56.7|||<|0.0001|TWO_SIDED|95.0|38.4|74.9|||Poisson model for rate difference|||||74.9|38.4|<0.0001
73962159|NCT02528188|147460934|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.11||0.0148|TWO_SIDED|95.0|-0.46|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.46|0.0148
73902912|NCT02129777|147336378|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|1.76||0.11|TWO_SIDED|95.0|-0.7|6.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||6.3|-0.7|0.110
73962160|NCT02528188|147460934|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1597|TWO_SIDED|95.0|-0.36|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.36|0.1597
74024584|NCT00389207|147601527|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.016||||0.5659|TWO_SIDED|95.0|-0.039|0.071|||Cochran Chi-Squared|||week 144||0.071|-0.039|0.5659
73902913|NCT02129777|147336379|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.027||||0.827|TWO_SIDED|95.0|-0.265|0.211|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.211|-0.265|0.827
74024585|NCT00389207|147601528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.0002||95.0|0.57|0.839|||Regression, Cox|||||0.839|0.570|0.0002
74024586|NCT00389207|147601528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001||95.0|0.519|0.764|||Regression, Cox|||Cox regression on responders only (N=289 in Nevirapine QD+BID and N=175 in Atazanvir/ritonavir)||0.764|0.519|<0.0001
74024587|NCT00389207|147601529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.762||||0.1329||95.0|0.535|1.086|||Regression, Cox|||||1.086|0.535|0.1329
74024588|NCT00389207|147601530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.731||||0.0444||95.0|0.539|0.992|||Regression, Cox|||||0.992|0.539|0.0444
73902914|NCT02129777|147336379|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.036||||0.768|TWO_SIDED|95.0|-0.269|0.198|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.198|-0.269|0.768
73902915|NCT02129777|147336379|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.112||||0.338|TWO_SIDED|95.0|-0.33|0.106|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.106|-0.330|0.338
73902916|NCT02129777|147336379|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.017||||0.89|TWO_SIDED|95.0|-0.261|0.226|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.226|-0.261|0.890
73902917|NCT02129777|147336380|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.048||||0.295|TWO_SIDED|95.0|-0.043|0.139|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12:CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.139|-0.043|0.295
73902918|NCT02129777|147336381|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.012||||0.906|TWO_SIDED|95.0|-0.191|0.216|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.216|-0.191|0.906
73902919|NCT02129777|147336381|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.04||||0.677|TWO_SIDED|95.0|-0.222|0.143|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.143|-0.222|0.677
73902920|NCT02129777|147336381|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13||||0.107|TWO_SIDED|95.0|-0.268|0.007|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.007|-0.268|0.107
73902921|NCT02129777|147336381|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.371|TWO_SIDED|95.0|-0.248|0.087|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.087|-0.248|0.371
73902922|NCT02129777|147336382|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.095||||0.134|TWO_SIDED|95.0|-0.03|0.221|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.221|-0.030|0.134
73902923|NCT02129777|147336383|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.258|TWO_SIDED|95.0|-0.6|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an analysis of variance (ANOVA) model with terms for treatment and study site.||0.2|-0.6|0.258
73902924|NCT02129777|147336383|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.365|TWO_SIDED|95.0|-0.5|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.2|-0.5|0.365
73902925|NCT02129777|147336383|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.757|TWO_SIDED|95.0|-0.3|0.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.4|-0.3|0.757
74024589|NCT02120417|147601555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.932||||0.762|TWO_SIDED|80.0|0.694|1.252|||Log Rank|The P-value was analyzed by Log-Rank Test stratified by Hormone Receptor Status.||||1.252|0.694|0.762
74024590|NCT02469246|147601565|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% confidence interval (CI) approach, with a non-inferiority margin of 10%.|Difference in Percentages|-3.8||||0.15|TWO_SIDED|95.002|-8.9|1.1|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of the primary efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||1.1|-8.9|0.15
74088272|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-2.74|STANDARD_ERROR_OF_MEAN|4.54||0.5483|TWO_SIDED|95.0|-11.78|6.3|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||6.30|-11.78|0.5483
73852701|NCT00301262|147253281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.13|STANDARD_ERROR_OF_MEAN|3.405|<|0.0001||95.0|11.4|24.86||Since there was only one primary endpoint no multiple comparison adjustments were made for primary analysis. Final stat. model included centre, treatment, smoking status and history of ED as factors, and age, duration of ED (baseline) as covariates.|ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|The primary analysis population was the FAS. The sample size was estimated based on an expected difference of 16.5 with a standard deviation of 28.4, based on previously observed data.||24.86|11.40|<0.0001
73902926|NCT02129777|147336383|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.825|TWO_SIDED|95.0|-0.4|0.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.3|-0.4|0.825
73902927|NCT02129777|147336384|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|2.163||0.931|TWO_SIDED|95.0|-4.48|4.1|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.10|-4.48|0.931
73902928|NCT02129777|147336384|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|STANDARD_ERROR_OF_MEAN|2.143||0.459|TWO_SIDED|95.0|-2.65|5.84|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.84|-2.65|0.459
73852702|NCT00301262|147253282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.09|STANDARD_DEVIATION|14.761||0.0028||95.0|1.8|8.37|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||8.370|1.800|0.0028
73852703|NCT00301262|147253282|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|26.02|STANDARD_DEVIATION|22.294|<|0.0001||95.0|20.58|31.455|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||31.455|20.580|<0.0001
73902929|NCT02129777|147336384|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.161||0.094|TWO_SIDED|95.0|-0.63|7.93|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.93|-0.63|0.094
73902930|NCT02129777|147336384|SUPERIORITY_OR_OTHER||LS Mean Difference|2.78|STANDARD_ERROR_OF_MEAN|2.173||0.203|TWO_SIDED|95.0|-1.52|7.09|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.09|-1.52|0.203
73902931|NCT02129777|147336385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.7||0.448|TWO_SIDED|95.0|-1.92|0.86|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.86|-1.92|0.448
73902932|NCT02129777|147336385|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.692||0.099|TWO_SIDED|95.0|-2.53|0.22|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.22|-2.53|0.099
73971029|NCT04119843|147482211|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.95|STANDARD_DEVIATION|0.852|<|0.001|TWO_SIDED|95.0|0.726|1.166|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 1||1.166|0.726|<0.001
73852704|NCT00301262|147253283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|0.656||0.008||95.0|0.47|3.06|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||3.06|0.47|0.0080
73852705|NCT00301262|147253284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.94|STANDARD_DEVIATION|2.909||0.0051||95.0|0.29|1.585|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.585|0.290|0.0051
73902933|NCT02129777|147336385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.69||0.396|TWO_SIDED|95.0|-1.96|0.78|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.78|-1.96|0.396
73902934|NCT02129777|147336385|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.697||0.102|TWO_SIDED|95.0|-2.54|0.23|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.23|-2.54|0.102
73902935|NCT02129777|147336386|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.626||0.099|TWO_SIDED|95.0|-2.29|-0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||-0.20|-2.29|0.099
73902936|NCT02129777|147336386|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.619||0.045|TWO_SIDED|95.0|-2.49|-0.03|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||-0.03|-2.49|0.045
73852706|NCT00301262|147253284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.79|STANDARD_DEVIATION|4.013|<|0.0001||95.0|1.812|3.77|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.770|1.812|<0.0001
73852707|NCT00301262|147253285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.61|STANDARD_ERROR_OF_MEAN|0.922||0.0054||95.0|0.78|4.43|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||4.43|0.78|0.0054
73852708|NCT00301262|147253286|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.368||0.4232||95.0|-0.43|1.02|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.02|-0.43|0.4232
73852709|NCT00301262|147253287|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.277||0.0156||95.0|0.13|1.22|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.22|0.13|0.0156
73852710|NCT00301262|147253288|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.458||0.0096||95.0|0.3|2.11|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||2.11|0.30|0.0096
73852711|NCT00301262|147253289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.359||0.0135||95.0|0.19|1.61|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.61|0.19|0.0135
73852712|NCT00301262|147253290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.49|STANDARD_DEVIATION|4.392||0.0033||95.0|0.051|2.465|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.465|0.0510|0.0033
73852713|NCT00301262|147253290|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.22|STANDARD_DEVIATION|6.346|<|0.0001||95.0|3.676|6.772|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||6.772|3.676|<0.0001
73852714|NCT00301262|147253291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.57||0.2581||95.0|-0.149|0.549|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.549|-0.149|0.2581
73852715|NCT00301262|147253291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.39|STANDARD_DEVIATION|2.582|<|0.0001||95.0|0.758|2.018|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.018|0.758|<0.0001
73852716|NCT00301262|147253292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.18|STANDARD_DEVIATION|1.456||0.2857||95.0|-0.149|0.499|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.499|-0.149|0.2857
73852717|NCT00301262|147253292|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.76|STANDARD_DEVIATION|1.706||0.0005||95.0|0.345|1.177|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.177|0.345|0.0005
73852718|NCT00301262|147253293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.75|STANDARD_DEVIATION|2.548||0.0102||95.0|0.183|1.317|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.317|0.183|0.0102
73852719|NCT00301262|147253293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.28|STANDARD_DEVIATION|2.979|<|0.0001||95.0|1.557|3.01|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.010|1.557|<0.0001
73852720|NCT00301262|147253294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.68|STANDARD_DEVIATION|1.847||0.0016||95.0|0.264|1.086|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.086|0.264|0.0016
73852721|NCT00301262|147253294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.9|STANDARD_DEVIATION|2.297|<|0.0001||95.0|1.335|2.456|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.456|1.335|<0.0001
73852722|NCT00301262|147253295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.78|STANDARD_ERROR_OF_MEAN|1.038||0.0083||95.0|0.73|4.83|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||4.83|0.73|0.0083
73852723|NCT00301262|147253296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|5.193||0.9146||95.0|-1.218|1.093|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.093|-1.218|0.9146
73852724|NCT00301262|147253296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.54|STANDARD_DEVIATION|6.463|<|0.0001||95.0|3.961|7.114|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||7.114|3.961|<0.0001
73852725|NCT00301262|147253297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.42|STANDARD_ERROR_OF_MEAN|4.826||0.0002||95.0|8.88|27.96|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||27.96|8.88|0.0002
73852726|NCT00301262|147253298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.41|STANDARD_DEVIATION|20.444||0.0064||95.0|1.857|10.956|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||10.956|1.857|0.0064
73902937|NCT02129777|147336386|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.62||0.118|TWO_SIDED|95.0|-2.21|0.25|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.25|-2.21|0.118
73902938|NCT02129777|147336386|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.616||0.05|TWO_SIDED|95.0|-2.44|0.0|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.00|-2.44|0.050
73971030|NCT04119843|147482211|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.73|STANDARD_DEVIATION|1.261|<|0.001|TWO_SIDED|95.0|0.38|1.082|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 2||1.082|0.380|<0.001
73852727|NCT00301262|147253298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|26.8|STANDARD_DEVIATION|29.384|<|0.0001|TWO_SIDED|95.0|19.636|33.971|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||33.971|19.636|<0.0001
73852728|NCT00301262|147253299|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.491||||0.0001||95.0|3.042|13.851|||Regression, Logistic|||||13.851|3.042|0.0001
73852729|NCT00301262|147253300|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.915|||<|0.0001||95.0|2.396|10.08|||Regression, Logistic|||||10.080|2.396|<0.0001
73852730|NCT00301262|147253301|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.676||||0.0187||95.0|1.242|10.875|||Regression, Logistic|||||10.875|1.242|0.0187
73852731|NCT00301262|147253302|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.9|STANDARD_ERROR_OF_MEAN|4.716||0.0037||95.0|4.59|23.22|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||23.22|4.59|0.0037
73852732|NCT00301262|147253303|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.72|STANDARD_ERROR_OF_MEAN|4.496||0.0321||95.0|0.84|18.6|||independent-samples t-test||Mean Difference = Week 8 - Baseline|||18.60|0.84|0.0321
73852733|NCT00301262|147253304|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.97|STANDARD_ERROR_OF_MEAN|3.901||0.0427||95.0|-15.68|-0.27|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||-0.27|-15.68|0.0427
73852734|NCT00301262|147253305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.6|STANDARD_ERROR_OF_MEAN|3.903||0.0533||95.0|-15.32|0.11|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.11|-15.32|0.0533
73852735|NCT00301262|147253306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.167|STANDARD_ERROR_OF_MEAN|0.3041||0.0002||95.0|0.566|1.768|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.768|0.566|0.0002
73852736|NCT00301262|147253307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4454|STANDARD_ERROR_OF_MEAN|0.3638||0.0001||95.0|0.727|2.164|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||2.164|0.727|0.0001
73852737|NCT00301262|147253308|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.1821|STANDARD_ERROR_OF_MEAN|0.3946||0.0032||95.0|0.403|1.961|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.961|0.403|0.0032
73852738|NCT00301262|147253309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2123|STANDARD_ERROR_OF_MEAN|0.3549||0.0008||95.0|0.511|1.913|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.913|0.511|0.0008
73852739|NCT00301262|147253310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.454||0.0195||95.0|0.064|0.711|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.711|0.064|0.0195
73852740|NCT00301262|147253310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.09|STANDARD_DEVIATION|2.207|<|0.0001||95.0|1.551|2.628|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.628|1.551|<0.0001
73852741|NCT00301262|147253311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|1.489||0.0186||95.0|0.069|0.731|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.731|0.069|0.0186
73852742|NCT00301262|147253311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.67|STANDARD_DEVIATION|2.573|<|0.0001||95.0|2.044|3.299|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.299|2.044|<0.0001
73852743|NCT00301262|147253312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|STANDARD_DEVIATION|1.917||0.0033||95.0|0.223|1.077|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.077|0.223|0.0033
73852744|NCT00301262|147253312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.61|STANDARD_DEVIATION|2.335|<|0.0001||95.0|2.042|3.182|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.182|2.042|<0.0001
73852745|NCT00301262|147253313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.45|STANDARD_DEVIATION|1.606||0.0143||95.0|0.093|0.807|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.807|0.093|0.0143
73852746|NCT00301262|147253313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.99|STANDARD_DEVIATION|2.178|<|0.0001||95.0|1.454|2.516|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.516|1.454|<0.0001
73852747|NCT00301262|147253314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0325||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0325
73852748|NCT00301262|147253314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||<0.0001
73852749|NCT00301262|147253315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0196
73852750|NCT00301262|147253315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||<0.0001
73852751|NCT00301262|147253316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.3173
73852752|NCT00301262|147253316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0016
73902939|NCT02129777|147336387|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.503||0.211|TWO_SIDED|95.0|-1.63|0.36|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.36|-1.63|0.211
73852753|NCT00301262|147253317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.55|STANDARD_ERROR_OF_MEAN|2.958||0.0624||95.0|-11.39|0.29|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.29|-11.39|0.0624
73852754|NCT00301262|147253317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.38|STANDARD_ERROR_OF_MEAN|1.835||0.4523||95.0|-2.24|5.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.01|-2.24|0.4523
73852755|NCT00301262|147253318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.48|STANDARD_ERROR_OF_MEAN|1.962||0.2081||95.0|-6.35|1.4|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||1.40|-6.35|0.2081
73852756|NCT00301262|147253318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.61|STANDARD_ERROR_OF_MEAN|1.958||0.4131||95.0|-2.26|5.48|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.48|-2.26|0.4131
73852757|NCT00301262|147253319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.77|STANDARD_ERROR_OF_MEAN|2.126||0.4069||95.0|-5.97|2.43|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||2.43|-5.97|0.4069
73852758|NCT00301262|147253319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|1.489||0.1137||95.0|-0.57|5.31|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.31|-0.57|0.1137
73852759|NCT00301262|147253320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.23|STANDARD_ERROR_OF_MEAN|4.829||0.0123||95.0|-21.77|-2.7|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||-2.70|-21.77|0.0123
73852760|NCT00301262|147253320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|4.883||0.8993||95.0|-10.27|9.03|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||9.03|-10.27|0.8993
73930717|NCT03238911|147391297|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.0257|TWO_SIDED|95.0|0.05|0.74|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.74|0.05|0.0257
74088273|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-6.75|STANDARD_ERROR_OF_MEAN|3.79||0.0774|TWO_SIDED|95.0|-14.26|0.76|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.76|-14.26|0.0774
73852761|NCT00301262|147253321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|22.03|STANDARD_ERROR_OF_MEAN|5.458|<|0.0001||95.0|11.25|32.81|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||32.81|11.25|<0.0001
73852762|NCT00301262|147253321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.74|STANDARD_ERROR_OF_MEAN|5.818||0.4165||95.0|-16.24|6.76|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||6.76|-16.24|0.4165
73852763|NCT00301262|147253322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.8|STANDARD_ERROR_OF_MEAN|4.351||0.0257||95.0|1.21|18.39|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||18.39|1.21|0.0257
73852764|NCT00301262|147253322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.36|STANDARD_ERROR_OF_MEAN|3.209||0.0971||95.0|-11.7|0.98|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.98|-11.70|0.0971
73852765|NCT00301262|147253323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.18|STANDARD_ERROR_OF_MEAN|1.754||0.0726||95.0|-6.66|0.3|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.30|-6.66|0.0726
73852766|NCT00301262|147253323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|1.798||0.2581||95.0|-5.61|1.52|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||1.52|-5.61|0.2581
73971031|NCT04119843|147482211|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.786|<|0.001|TWO_SIDED|95.0|0.517|0.927|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 3||0.927|0.517|<0.001
73852767|NCT00301262|147253324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|4.45||0.8158||95.0|-9.86|7.78|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||7.78|-9.86|0.8158
73852768|NCT00301262|147253324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.692||0.8464||95.0|-3.68|3.02|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||3.02|-3.68|0.8464
73852769|NCT00301262|147253325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|5.789||0.9529||95.0|-11.82|11.13|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||11.13|-11.82|0.9529
73852770|NCT00301262|147253325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|4.994||0.8899||95.0|-10.59|9.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||9.20|-10.59|0.8899
73852771|NCT00301262|147253326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.18|STANDARD_ERROR_OF_MEAN|7.897||0.2001||95.0|-25.83|5.47|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.47|-25.83|0.2001
73852772|NCT00301262|147253326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.68|STANDARD_ERROR_OF_MEAN|6.724||0.1527||95.0|-3.64|23.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||23.01|-3.64|0.1527
73852773|NCT00301262|147253327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.74|STANDARD_ERROR_OF_MEAN|7.774||0.0606||95.0|-0.67|30.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||30.15|-0.67|0.0606
73852774|NCT00301262|147253327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.62|STANDARD_ERROR_OF_MEAN|7.318||0.3678||95.0|-21.12|7.88|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||7.88|-21.12|0.3678
73852775|NCT00301262|147253328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|7.474||0.5429||95.0|-10.25|19.37|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||19.37|-10.25|0.5429
73852776|NCT00301262|147253328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.07|STANDARD_ERROR_OF_MEAN|5.595||0.5849||95.0|-8.02|14.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||14.15|-8.02|0.5849
73852777|NCT00301262|147253329|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.86|STANDARD_ERROR_OF_MEAN|4.952||0.0002||95.0|9.08|28.64|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||28.64|9.08|0.0002
73852778|NCT00301262|147253329|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.93|STANDARD_ERROR_OF_MEAN|6.212||0.429||95.0|-7.35|17.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||17.20|-7.35|0.4290
73971032|NCT05034328|147482252|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73902940|NCT02129777|147336387|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.497||0.087|TWO_SIDED|95.0|-1.85|0.13|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.13|-1.85|0.087
73902941|NCT02129777|147336387|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.494||0.58|TWO_SIDED|95.0|-1.26|0.71|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.71|-1.26|0.580
73902942|NCT02129777|147336387|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.496||0.873|TWO_SIDED|95.0|-1.06|0.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.90|-1.06|0.873
73902943|NCT02129777|147336388|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|6.7||0.803|TWO_SIDED|95.0|-15.2|11.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||11.8|-15.2|0.803
73902944|NCT02129777|147336388|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|6.73||0.248|TWO_SIDED|95.0|-5.7|21.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||21.4|-5.7|0.248
73902945|NCT02129777|147336388|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|6.67||0.914|TWO_SIDED|95.0|-12.7|14.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||14.2|-12.7|0.914
73902946|NCT02129777|147336388|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|6.74||0.523|TWO_SIDED|95.0|-9.2|17.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||17.9|-9.2|0.523
73902947|NCT02129777|147336389|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.37||0.978|TWO_SIDED|95.0|-2.7|2.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an Analysis of covariance (ANCOVA) model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||2.8|-2.7|0.978
73902948|NCT02129777|147336389|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.36||0.389|TWO_SIDED|95.0|-3.9|1.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.5|-3.9|0.389
73902949|NCT02129777|147336389|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.39||0.316|TWO_SIDED|95.0|-4.2|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.4|-4.2|0.316
73962161|NCT02528188|147460935|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.1||0.003|TWO_SIDED|95.0|-0.52|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.11|-0.52|0.0030
73971033|NCT05034328|147482253|SUPERIORITY||Hazard Ratio (HR)|1.063||||0.7026|TWO_SIDED|95.0|0.778|1.451|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treament chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.451|0.778|0.7026
73902950|NCT02129777|147336389|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.41||0.142|TWO_SIDED|95.0|-4.9|0.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.7|-4.9|0.142
73902951|NCT02129777|147336390|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.73||0.229|TWO_SIDED|95.0|-5.6|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.4|-5.6|0.229
73902952|NCT02129777|147336390|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.65||0.863|TWO_SIDED|95.0|-3.6|3.0|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||3.0|-3.6|0.863
73902953|NCT02129777|147336390|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.403|TWO_SIDED|95.0|-1.9|4.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.7|-1.9|0.403
73902954|NCT02129777|147336390|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.74||0.597|TWO_SIDED|95.0|-2.5|4.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.4|-2.5|0.597
73902955|NCT02129777|147336390|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|2.32||0.416|TWO_SIDED|95.0|-2.7|6.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||6.5|-2.7|0.416
73902956|NCT02129777|147336390|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.24||0.77|TWO_SIDED|95.0|-3.8|5.1|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.1|-3.8|0.770
73902957|NCT02129777|147336390|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.31||0.798|TWO_SIDED|95.0|-4.0|5.2|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.2|-4.0|0.798
74084877|NCT04284553|147723129|SUPERIORITY||Mean Difference (Final Values)|39.5|||||TWO_SIDED|95.0|11.6|67.4|||||"The estimate compares having cold-state priming as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having cold-state priming in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||67.4|11.6|
73902958|NCT02129777|147336390|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.767|TWO_SIDED|95.0|-4.1|5.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.5|-4.1|0.767
73902959|NCT02129777|147336391|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.043||0.57|TWO_SIDED|95.0|-0.11|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.06|-0.11|0.570
73971034|NCT05034328|147482254|SUPERIORITY||Hazard Ratio (HR)|1.078||||0.6322|TWO_SIDED|95.0|0.792|1.469|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.469|0.792|0.6322
73971035|NCT05034328|147482255|SUPERIORITY||Hazard Ratio (HR)|0.992||||0.9598|TWO_SIDED|95.0|0.726|1.356|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.356|0.726|0.9598
73971036|NCT05034328|147482256|SUPERIORITY||Hazard Ratio (HR)|1.333||||0.1016|TWO_SIDED|95.0|0.945|1.88|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.880|0.945|0.1016
73852779|NCT00368745|147253330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2838||95.0||||significance determined using 2-tailed significance level of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with country as a covariate||Primary objective: evaluate the efficacy of pregabalin in maintaining the benzodiazepine free state in subjects with prior stable alprazolam use.||||0.2838
73852780|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.81||0.0709||95.0|-3.1|0.13||contrasts performed using Dunnett's Test|ANCOVA|Least squares (LS) Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1||0.13|-3.10|0.0709
73852781|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.89|STANDARD_ERROR_OF_MEAN|1.08||0.0006||95.0|-6.04|-1.74||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2||-1.74|-6.04|0.0006
73852782|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|1.3||0.0718||95.0|-4.98|0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3||0.22|-4.98|0.0718
73852783|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.38|STANDARD_ERROR_OF_MEAN|1.92||0.092||95.0|-7.37|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4||0.60|-7.37|0.0920
73852784|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|3.04||0.1371||95.0|-12.67|2.23||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT week 5||2.23|-12.67|0.1371
73852785|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|2.04||0.0882||95.0|-7.96|0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6||0.61|-7.96|0.0882
73852786|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.83|STANDARD_ERROR_OF_MEAN|1.11||0.0135||95.0|-5.05|-0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1||-0.61|-5.05|0.0135
73852787|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.18||0.3924||95.0|-3.38|1.35||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2||1.35|-3.38|0.3924
73852788|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.14||0.3868||95.0|-3.29|1.3||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3||1.30|-3.29|0.3868
73852789|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.15||0.9966||95.0|-2.31|2.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4||2.32|-2.31|0.9966
73852790|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|1.26||0.6873||95.0|-3.07|2.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5||2.05|-3.07|0.6873
73852791|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.35||0.5337||95.0|-3.62|1.91||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6||1.91|-3.62|0.5337
73852792|NCT00368745|147253331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.79|STANDARD_ERROR_OF_MEAN|1.37||0.0008||95.0|-7.51|-2.07||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint \[LOCF\]||-2.07|-7.51|0.0008
73852793|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|1.4||0.122||95.0|-4.97|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||0.60|-4.97|0.1220
73852794|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.63|STANDARD_ERROR_OF_MEAN|1.26||0.0053||95.0|-6.15|-1.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-1.11|-6.15|0.0053
73852795|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85|STANDARD_ERROR_OF_MEAN|1.73||0.1048||95.0|-6.32|0.62||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.62|-6.32|0.1048
73852796|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.41|STANDARD_ERROR_OF_MEAN|1.52||0.0357||95.0|-6.57|-0.25||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||-0.25|-6.57|0.0357
73852797|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|2.67||0.4263||95.0|-8.82|4.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||4.26|-8.82|0.4263
73852798|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.73|STANDARD_ERROR_OF_MEAN|2.02||0.0104||95.0|-9.96|-1.51||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||-1.51|-9.96|0.0104
73852799|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|1.4||0.0069||95.0|-6.73|-1.12||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||-1.12|-6.73|0.0069
73852800|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|1.37||0.2185||95.0|-4.47|1.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||1.05|-4.47|0.2185
73852801|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.06||0.7832||95.0|-2.41|1.83||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||1.83|-2.41|0.7832
73852802|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.16||0.7062||95.0|-1.9|2.79||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||2.79|-1.90|0.7062
73852803|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|1.04||0.7161||95.0|-2.49|1.73||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||1.73|-2.49|0.7161
73852804|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.11|STANDARD_ERROR_OF_MEAN|1.43||0.0376||95.0|-6.03|-0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||-0.19|-6.03|0.0376
73852805|NCT00368745|147253334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|1.48||0.0122||95.0|-6.74|-0.85||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.85|-6.74|0.0122
73852806|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0052||95.0|-0.76|-0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1||-0.14|-0.76|0.0052
73852807|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.18||0.0001||95.0|-1.11|-0.38||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2||-0.38|-1.11|0.0001
73852808|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0528||95.0|-1.0|0.01||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3||0.01|-1.00|0.0528
73852809|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.35||0.3085||95.0|-1.11|0.37||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4||0.37|-1.11|0.3085
73852810|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.47||0.1807||95.0|-1.92|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 5||0.47|-1.92|0.1807
73962162|NCT02528188|147460935|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.11||0.0691|TWO_SIDED|95.0|-0.4|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.40|0.0691
73962163|NCT02528188|147460936|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3431|TWO_SIDED|95.0|-0.11|0.04||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.11|0.3431
73962164|NCT02528188|147460936|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6332|TWO_SIDED|95.0|-0.09|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.09|0.6332
73962165|NCT02528188|147460937|SUPERIORITY||Risk Difference (RD)|0.5||||0.4082|TWO_SIDED|95.0|-0.75|2.28|||Exact methods for risk difference|||||2.28|-0.75|0.4082
73962166|NCT02528188|147460937|SUPERIORITY||Risk Difference (RD)|1.7||||0.0238|TWO_SIDED|95.0|0.31|3.63|||Exact methods for risk difference|||||3.63|0.31|0.0238
73962167|NCT02528188|147460938|SUPERIORITY||Rate Difference|4.8||||0.2035|TWO_SIDED|95.0|-2.6|12.2|||Poisson model for rate difference|||||12.2|-2.6|0.2035
73962168|NCT02528188|147460938|SUPERIORITY||Rate Difference|16.9||||0.001|TWO_SIDED|95.0|6.8|27.0|||Poisson model for rate difference|||||27.0|6.8|0.0010
73962169|NCT02528188|147460939|SUPERIORITY||Risk Difference|1.99||||0.0248|TWO_SIDED|95.0|0.31|4.17|||Exact methods for risk difference|||Rapidly progressive OA Type 1 or 2||4.17|0.31|0.0248
73962170|NCT02528188|147460939|SUPERIORITY||Risk difference|5.11|||<|0.0001|TWO_SIDED|95.0|3.16|7.54|||Exact methods for risk difference|||Rapidly Progressive OA Type 1 or 2||7.54|3.16|<0.0001
73962171|NCT02528188|147460939|SUPERIORITY||Risk difference|1.79||||0.0366|TWO_SIDED|95.0|0.16|3.92|||Exact methods for risk difference|||Rapidly Progressive OA Type 1||3.92|0.16|0.0366
74024591|NCT02469246|147601566|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|-6.3||||0.042|TWO_SIDED|95.0|-12.3|-0.3|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||-0.3|-12.3|0.042
73852811|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.42||0.1074||95.0|-1.58|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6||0.17|-1.58|0.1074
73852812|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.2||0.0013||95.0|-1.1|-0.28||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1||-0.28|-1.10|0.0013
73852813|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0503||95.0|-0.99|0.0||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2||0.00|-0.99|0.0503
73852814|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.26||0.0364||95.0|-1.09|-0.04||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3||-0.04|-1.09|0.0364
73852815|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.24||0.914||95.0|-0.51|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4||0.46|-0.51|0.9140
73852816|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.27||0.7789||95.0|-0.62|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5||0.47|-0.62|0.7789
73962172|NCT02528188|147460939|SUPERIORITY||Risk difference|3.81||||0.0001|TWO_SIDED|95.0|1.99|6.12|||Exact methods for risk difference|||Rapidly Progressive OA Type 1||6.12|1.99|0.0001
74024592|NCT02469246|147601567|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.1||||0.45|TWO_SIDED|95.002|-1.0|3.5|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||3.5|-1.0|0.45
74024593|NCT02469246|147601568|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.4||||0.34|TWO_SIDED|95.0|-1.0|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||4.2|-1.0|0.34
73852817|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.31||0.3189||95.0|-0.95|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6||0.32|-0.95|0.3189
73852818|NCT00368745|147253336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.0031||95.0|-1.26|-0.27||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint \[LOCF\]||-0.27|-1.26|0.0031
73852819|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.24||0.126||95.0|-0.86|0.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||0.11|-0.86|0.1260
73852820|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.29||0.0074||95.0|-1.4|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-0.22|-1.40|0.0074
73852821|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.125||95.0|-1.35|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.17|-1.35|0.1250
73852822|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.6||0.8991||95.0|-1.17|1.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||1.32|-1.17|0.8991
73852823|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.53||0.1747||95.0|-2.07|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||0.46|-2.07|0.1747
73852824|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.45||0.0744||95.0|-1.79|0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||0.09|-1.79|0.0744
73852825|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.35||0.0063||95.0|-1.67|-0.29||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||-0.29|-1.67|0.0063
73852826|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.34||0.014||95.0|-1.56|-0.18||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||-0.18|-1.56|0.0140
73852827|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.34||0.0267||95.0|-1.46|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||-0.09|-1.46|0.0267
74024594|NCT02469246|147601569|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-1.6||||0.62|TWO_SIDED|95.0|-7.4|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||4.2|-7.4|0.62
74024595|NCT02469246|147601570|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-5.9||||0.069|TWO_SIDED|95.0|-12.2|0.4|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||0.4|-12.2|0.069
74024596|NCT02469246|147601571|SUPERIORITY||Difference in LSM|-32.0||||0.026|TWO_SIDED|95.0|-61.0|-4.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||-4|-61|0.026
74024597|NCT02469246|147601572|SUPERIORITY||Difference in LSM|-39.0||||0.013|TWO_SIDED|95.0|-70.0|-8.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||-8|-70|0.013
74024598|NCT02469246|147601573|SUPERIORITY||Difference in LSM|0.179||||0.4|TWO_SIDED|95.0|-0.24|0.598||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.598|-0.240|0.40
73902960|NCT02129777|147336391|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.042||0.619|TWO_SIDED|95.0|-0.1|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.06|-0.10|0.619
74024599|NCT02469246|147601574|SUPERIORITY||Difference in LSM|0.165||||0.53|TWO_SIDED|95.0|-0.348|0.678||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.678|-0.348|0.53
74024600|NCT02469246|147601575|SUPERIORITY||Difference in LSM|0.151||||0.63|TWO_SIDED|95.0|-0.465|0.767||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.767|-0.465|0.63
74024601|NCT02469246|147601576|SUPERIORITY||Difference in LSM|-0.056||||0.89|TWO_SIDED|95.0|-0.825|0.713||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.713|-0.825|0.89
73852828|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.38||0.5104||95.0|-1.03|0.52||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||0.52|-1.03|0.5104
73852829|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.43||0.2702||95.0|-1.35|0.39||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||0.39|-1.35|0.2702
74024602|NCT03352245|147601586|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.2||0.889|TWO_SIDED||||||Mixed Models Analysis|||||||0.889
74088274|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-12.48|STANDARD_ERROR_OF_MEAN|3.87||0.0017|TWO_SIDED|95.0|-20.15|-4.81|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-4.81|-20.15|0.0017
73852830|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.42||0.1241||95.0|-1.52|0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||0.19|-1.52|0.1241
73902961|NCT02129777|147336391|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.043||0.597|TWO_SIDED|95.0|-0.06|0.11|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.11|-0.06|0.597
74024603|NCT03352245|147601587|SUPERIORITY||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.88||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.20
74024604|NCT03352245|147601588|SUPERIORITY||Mean Difference (Net)|7.79|STANDARD_ERROR_OF_MEAN|5.51||0.166|TWO_SIDED||||||Mixed Models Analysis|||||||0.166
73852831|NCT00368745|147253337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.36||0.0109||95.0|-1.67|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.22|-1.67|0.0109
73852832|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.28||0.0226||95.0|-1.22|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||-0.09|-1.22|0.0226
73852833|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.34||0.0099||95.0|-1.58|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-0.22|-1.58|0.0099
74024605|NCT03352245|147601589|SUPERIORITY||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|3.41||0.853|TWO_SIDED||||||Mixed Models Analysis|||||||0.853
74024606|NCT03352245|147601590|SUPERIORITY||Mean Difference (Net)|17.04|STANDARD_ERROR_OF_MEAN|7.16||0.022|TWO_SIDED||||||Mixed Models Analysis|||||||0.022
73852834|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.35||0.2827||95.0|-1.07|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.32|-1.07|0.2827
73852835|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.58||0.8232||95.0|-1.07|1.34||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||1.34|-1.07|0.8232
73852836|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.66||0.2409||95.0|-2.41|0.72||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||0.72|-2.41|0.2409
73852837|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.61||0.476||95.0|-1.73|0.84||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||0.84|-1.73|0.4760
73852838|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.32||0.1252||95.0|-1.14|0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||0.14|-1.14|0.1252
73852839|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.33||0.0717||95.0|-1.26|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||0.06|-1.26|0.0717
73852840|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.35||0.0707||95.0|-1.33|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||0.06|-1.33|0.0707
73852841|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.39||0.4341||95.0|-1.08|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||0.47|-1.08|0.4341
73852842|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.42||0.37||95.0|-1.23|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||0.47|-1.23|0.3700
73852843|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.43||0.0328||95.0|-1.83|-0.08||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||-0.08|-1.83|0.0328
73852844|NCT00368745|147253338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.39||0.0096||95.0|-1.8|-0.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.26|-1.80|0.0096
73852845|NCT00368745|147253339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|2.68||0.8897||95.0|-5.74|4.99||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as the covariate||||4.99|-5.74|0.8897
73852846|NCT00368745|147253340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0626||95.0||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank|||||||0.0626
73852847|NCT00368745|147253341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank|||||||0.0148
73852848|NCT00368745|147253342|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1159||95.0||||p-value is obtained using Cochran-Mantel-Haenszel option|Cochran-Mantel-Haenszel|||||||0.1159
73852849|NCT00241176|147253373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)||YGTSS Global Severity score (M=61.8 SD=13.49) declined significantly to end point (M=33.7 SD=15.18; p=0.003).|Group 1 Baseline vs. Endpoint||||<.05
73852850|NCT00241176|147253374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)||Mean (SD) CGI-Tic severity scores reduced significantly from (M=4.45 SD=0.52) (moderate-marked) at baseline to (M=3.18 SD =0.60) (mild) at end point ( p=0.004).|Mean scores baseline to endpoint||||<.05
73852851|NCT03206970|147253392|OTHER||Clopper-Pearson|83.7|||<|0.0001|TWO_SIDED|95.0|74.2|90.8|||Binomial Exact Test|||A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)||90.8|74.2|<.0001
73852852|NCT03206970|147253396|SUPERIORITY||Clopper-Pearson|83.7|||<|0.0001|TWO_SIDED|95.0|74.2|90.8|||Binomial Exact Test|||A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)||90.8|74.2|<0.0001
73852853|NCT02516982|147253399|SUPERIORITY|||||||0.994|||||||Chi-squared, Corrected|||||||0.994
73852854|NCT02516982|147253400|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.7
73852855|NCT02516982|147253401|SUPERIORITY|||||||0.008|||||||Chi-squared, Corrected|||||||0.008
73852856|NCT02516982|147253402|SUPERIORITY|||||||0.919|||||||Chi-squared, Corrected|||||||0.919
73852857|NCT02516982|147253403|SUPERIORITY|||||||0.0001467|||||||Chi-squared, Corrected|||||||0.0001467
73852858|NCT02516982|147253404|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
73852859|NCT02516982|147253405|SUPERIORITY|||||||0.869|||||||Chi-squared, Corrected|||||||0.869
73852860|NCT01804049|147253411|SUPERIORITY|Hypothesis: metformin will reduce loss of total lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.45||||||For lean total body mass, t(118)=0.744, p=0.45.|t-test, 2 sided|T-test calculation for total lean mass: 0.74.||||||0.45
73852861|NCT01804049|147253411|SUPERIORITY|Hypothesis: metformin will reduce loss of total appendicular lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.79||||||For lean appendicular body mass, t(118) = 0.264, p=0.79.|t-test, 2 sided|T-test calculation appendicular lean mass: 0.26.||||||0.79
73852862|NCT01804049|147253412|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|t(118)=0.703, p=0.48||||||0.48
74024607|NCT03352245|147601591|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|3.83||0.911|TWO_SIDED||||||Mixed Models Analysis|||||||0.911
74024608|NCT03352245|147601592|SUPERIORITY||Mean Difference (Net)|-5.18|STANDARD_ERROR_OF_MEAN|6.88||0.456|TWO_SIDED||||||Mixed Models Analysis|||||||0.456
74024609|NCT03352245|147601593|SUPERIORITY||Mean Difference (Net)|-2.05|STANDARD_ERROR_OF_MEAN|3.13||0.515|TWO_SIDED||||||Mixed Models Analysis|||||||0.515
74024610|NCT03352245|147601594|SUPERIORITY||Mean Difference (Net)|-8.65|STANDARD_ERROR_OF_MEAN|5.8||0.144|TWO_SIDED||||||Mixed Models Analysis|||||||0.144
74024611|NCT03352245|147601595|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|6.28||0.948|TWO_SIDED||||||Mixed Models Analysis|||||||0.948
73852863|NCT03588806|147253414|SUPERIORITY|||||||0.218|||||||ANOVA|Univariate repeated measures ANOVA||||||0.218
73852864|NCT03588806|147253415|SUPERIORITY|||||||0.268|||||||ANOVA|Univariate repeated measures||||||0.268
73852865|NCT03588806|147253416|SUPERIORITY||||||<|0.001|||||||ANOVA|Univariate repeated measures ANOVA||||||<0.001
73852866|NCT03588806|147253417|SUPERIORITY|||||||0.228|||||||ANOVA|Univariate repeated measures ANOVA||||||0.228
73852867|NCT03588806|147253418|SUPERIORITY|||||||0.043|||||||ANOVA|Univariate repeated measures ANOVA||||||0.043
73852868|NCT03588806|147253419|SUPERIORITY|||||||0.486|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Social Roles score||||0.486
74024612|NCT03352245|147601596|SUPERIORITY||Mean Difference (Net)|-8.62|STANDARD_ERROR_OF_MEAN|7.45||0.254|TWO_SIDED||||||Mixed Models Analysis|||||||0.254
74024613|NCT03352245|147601597|SUPERIORITY||Mean Difference (Net)|-13.31|STANDARD_ERROR_OF_MEAN|6.62||0.051|TWO_SIDED||||||Mixed Models Analysis|||||||0.051
73852869|NCT03588806|147253419|SUPERIORITY|||||||0.078|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Sleep Disturbance T-Scores||||0.078
73852870|NCT03588806|147253419|SUPERIORITY|||||||0.874|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Depression T-Scores||||0.874
73852871|NCT03588806|147253419|SUPERIORITY|||||||0.389|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Anxiety T-Score||||0.389
73852872|NCT03588806|147253420|SUPERIORITY|||||||0.676|||||||ANOVA|Univariate repeated measures ANOVA||||||0.676
73852873|NCT03249909|147253422|NON_INFERIORITY|Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups with the two-sided Sign test on the Intent To Treat (ITT) population at 95% confidence interval.||||||0.0019|||||||Sign test|||||||0.0019
73852874|NCT01092780|147253436|SUPERIORITY_OR_OTHER||Difference in LS means|8.16|||||TWO_SIDED|95.0|6.11|10.2||||||Difference in least squares (LS) means||10.20|6.11|
73852875|NCT01092780|147253436|SUPERIORITY_OR_OTHER||Difference in LS means|8.11|||||TWO_SIDED|95.0|6.07|10.15||||||Difference in LS means||10.15|6.07|
73852876|NCT01092780|147253437|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.1|-0.05||||||Difference in LS means||-0.05|-0.10|
73852877|NCT01092780|147253437|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.09|-0.05||||||Difference in LS means||-0.05|-0.09|
73852878|NCT01092780|147253439|SUPERIORITY_OR_OTHER||Difference in LS means|-2.05|||||TWO_SIDED|90.0|-3.76|-0.35||||||Difference in LS means||-0.35|-3.76|
73852879|NCT01092780|147253439|SUPERIORITY_OR_OTHER||Difference in LS means|-2.1|||||TWO_SIDED|90.0|-3.79|-0.4||||||Difference in LS means||-0.40|-3.79|
73852880|NCT01092780|147253440|SUPERIORITY_OR_OTHER||Difference in LS means|10.21|||||TWO_SIDED|90.0|8.49|11.92||||||||11.92|8.49|
73852881|NCT01092780|147253441|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|90.0|-0.08|-0.05||||||Difference in LS means||-0.05|-0.08|
73852882|NCT00182078|147253463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_DEVIATION|3.4|=|0.017|TWO_SIDED|95.0|||||t-test, 2 sided|||||||=0.017
73852883|NCT00182078|147253464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|3.9|<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
73852884|NCT00182078|147253465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|4.4|=|0.65|TWO_SIDED|95.0|||||t-test, 2 sided|||||||=0.65
73852885|NCT01606176|147253466|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.39||||0.332|TWO_SIDED|95.0|-1.18|0.4|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"||0.40|-1.18|0.332
73852886|NCT01606176|147253467|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-29.55||||0.002|TWO_SIDED|95.0|-48.08|-11.02|||ANOVA|||The proportions were compared between treatment groups using analysis of variance (ANOVA) with treatment as a factor.||-11.02|-48.08|0.002
73962173|NCT02528188|147460939|SUPERIORITY||Risk difference|0.2||||0.6168|TWO_SIDED|95.0|-0.76|1.71|||Exact methods for risk difference|||Rapidly Progressive OA Type 2||1.71|-0.76|0.6168
74024614|NCT03352245|147601598|SUPERIORITY||Mean Difference (Net)|4.07|STANDARD_ERROR_OF_MEAN|8.71||0.643|TWO_SIDED||||||Mixed Models Analysis|||||||0.643
74024615|NCT03352245|147601599|SUPERIORITY||Mean Difference (Net)|-9.11|STANDARD_ERROR_OF_MEAN|8.5||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.290
74024616|NCT03352245|147601600|SUPERIORITY||Mean Difference (Net)|9.99|STANDARD_ERROR_OF_MEAN|5.49||0.077|TWO_SIDED||||||Mixed Models Analysis|||||||0.077
74024617|NCT03352245|147601601|SUPERIORITY||Mean Difference (Net)|5.27|STANDARD_ERROR_OF_MEAN|4.38||0.237|TWO_SIDED||||||Mixed Models Analysis|||||||0.237
74024618|NCT03352245|147601602|SUPERIORITY||Mean Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|6.49||0.861|TWO_SIDED||||||Mixed Models Analysis|||||||0.861
74024619|NCT02690701|147601610|SUPERIORITY|This superiority trial compares secukinumab with placebo with a view of demonstrating the superiority of secukinumab over placebo with regards to a specific outcome measure.|Least Square Mean|-0.053|STANDARD_ERROR_OF_MEAN|0.059||0.3712|TWO_SIDED|95.0|-0.169|0.064|||ANCOVA|||Statistical analysis (Analysis of Covariance) of change from baseline in target to background ratio for regions of the aorta at Week 12 (Full Analysis Set)||0.064|-0.169|0.3712
74024620|NCT01642212|147601640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
74024621|NCT01642212|147601641|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.75||||0.0096|TWO_SIDED|95.0|-11.808|-1.687||LS mean estimates were determined using an ANCOVA model including treatment group as a factor and the baseline score as a covariate.|ANCOVA|||||-1.687|-11.808|0.0096
73852887|NCT01606176|147253468|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.34||||0.052|TWO_SIDED|95.0|-0.68|0.0|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"||0.00|-0.68|0.052
73852888|NCT01606176|147253469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.79||||0.3|TWO_SIDED|95.0|-8.14|2.56|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"||2.56|-8.14|0.300
73852889|NCT01606176|147253470|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.66||||0.233|TWO_SIDED|95.0|-4.42|1.1|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"||1.10|-4.42|0.233
73852890|NCT01606176|147253471|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.28||||0.387|TWO_SIDED|95.0|-0.36|0.91|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"||0.91|-0.36|0.387
73852891|NCT01606176|147253472|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.47||||1|TWO_SIDED|95.0|-21.56|18.51|||Fisher Exact|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test."||18.51|-21.56|1.000
73852892|NCT01606176|147253473|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.86||||0.128|TWO_SIDED|95.0|-1.97|0.26|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"||0.26|-1.97|0.128
73852893|NCT01606176|147253474|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-31.77||||0.009|TWO_SIDED|95.0|-55.07|-8.47|||ANOVA|||The proportions were compared between treatment groups using ANOVA with treatment as a factor.||-8.47|-55.07|0.009
73852894|NCT01606176|147253475|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.32||||0.184|TWO_SIDED|95.0|-0.8|0.16|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"||0.16|-0.80|0.184
73852895|NCT01606176|147253476|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.18||||0.134|TWO_SIDED|95.0|-12.05|1.68|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"||1.68|-12.05|0.134
73852896|NCT01606176|147253477|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-3.77||||0.031|TWO_SIDED|95.0|-7.17|-0.36|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"||-0.36|-7.17|0.031
73852897|NCT01606176|147253478|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.04||||0.915|TWO_SIDED|95.0|-0.79|0.88|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"||0.88|-0.79|0.915
73852898|NCT01606176|147253479|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.95||||1|TWO_SIDED|95.0|-21.85|27.47|||Fisher Exact|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test."||27.47|-21.85|1.00
73852899|NCT01153711|147253505|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|168.4|STANDARD_DEVIATION|16.4||1|TWO_SIDED|90.0|155.5|182.4||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol||182.4|155.5|1.0000
73852900|NCT01153711|147253506|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|166.1|STANDARD_DEVIATION|16.8||1|TWO_SIDED|90.0|153.6|179.6||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol||179.6|153.6|1.0000
73852901|NCT01153711|147253506|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|106.63|STANDARD_DEVIATION|14.7||0.0001|TWO_SIDED|90.0|100.211|113.463||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide||113.463|100.211|0.0001
73852902|NCT01153711|147253509|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|144.23|STANDARD_DEVIATION|17.8||0.9986|TWO_SIDED|90.0|133.853|155.417||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol||155.417|133.853|0.9986
73962174|NCT02528188|147460939|SUPERIORITY||Risk difference|1.3||||0.0388|TWO_SIDED|95.0|0.17|2.97|||Exact methods for risk difference|||Rapidly Progressive OA Type 2||2.97|0.17|0.0388
73962175|NCT02528188|147460939|SUPERIORITY||Risk difference|0.1||||0.7245|TWO_SIDED|95.0|-0.74|1.51|||Exact methods for risk difference|||Primary osteonecrosis||1.51|-0.74|0.7245
74024622|NCT01642212|147601642|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.49||||0.2649|TWO_SIDED|95.0|-6.895|1.92||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||1.920|-6.895|0.2649
74024623|NCT01642212|147601642|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.91||||0.2878|TWO_SIDED|95.0|-8.322|2.501||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||2.501|-8.322|0.2878
73902962|NCT02129777|147336391|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.044||0.509|TWO_SIDED|95.0|-0.06|0.12|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.12|-0.06|0.509
73902963|NCT02129777|147336392|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|5.32||0.845|TWO_SIDED|95.0|-11.7|9.6|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||9.6|-11.7|0.845
73902964|NCT02129777|147336392|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|4.8||0.323|TWO_SIDED|95.0|-4.8|14.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||14.4|-4.8|0.323
73902965|NCT02129777|147336392|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|4.89||0.697|TWO_SIDED|95.0|-11.7|7.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.8|-11.7|0.697
73902966|NCT02129777|147336392|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.1||0.633|TWO_SIDED|95.0|-12.6|7.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.7|-12.6|0.633
73902967|NCT02129777|147336393|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.64||0.537|TWO_SIDED|95.0|-2.2|4.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.3|-2.2|0.537
73902968|NCT02129777|147336393|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|1.62||0.142|TWO_SIDED|95.0|-0.8|5.6|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.6|-0.8|0.142
73902969|NCT02129777|147336393|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.63||0.015|TWO_SIDED|95.0|0.8|7.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.3|0.8|0.015
73902970|NCT02129777|147336393|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.64||0.121|TWO_SIDED|95.0|-0.7|5.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.8|-0.7|0.121
73902971|NCT01255787|147336467|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|1.123||0.907|TWO_SIDED|95.0|-3.258|2.035||Adjustment for multiplicity for the comparisons was based on the Dunnett-Hsu procedure.|ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance.||2.035|-3.258|0.9070
74024624|NCT01642212|147601644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Fisher Exact|||Analysis of \</= 15 Eosinophils/HPF||||0.0001
74024625|NCT01642212|147601644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||Analysis of \</= 1 Eosinophils/HPF||||<0.0001
73852903|NCT01153711|147253509|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|132.87|STANDARD_DEVIATION|18.9||0.8991|TWO_SIDED|90.0|122.732|143.843||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide||143.843|122.732|0.8991
73852904|NCT01153711|147253510|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|100.75|STANDARD_DEVIATION|17.9||0.0001|TWO_SIDED|90.0|92.534|109.692||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol||109.692|92.534|0.0001
73902972|NCT01255787|147336467|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|1.114||0.3006|TWO_SIDED|95.0|-4.31|0.938|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||||0.938|-4.310|0.3006
73902973|NCT01255787|147336467|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|1.11||0.2399|TWO_SIDED|95.0|-4.436|0.794|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||||0.794|-4.436|0.2399
73902974|NCT03170232|147336476|OTHER||Mean Difference (Final Values)|-67.2|STANDARD_ERROR_OF_MEAN|159.7||0.679|TWO_SIDED|95.0|-400.6|266.2|||Repeated measures random coefficient|||||266.2|-400.6|0.679
73902975|NCT00718237|147336509|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|80.2|||<|0.001|TWO_SIDED|95.0|47.4|94.1||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||94.1|47.4|<0.001
73902976|NCT00718237|147336510|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|74.5|||<|0.001|TWO_SIDED|95.0|39.9|90.6||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||90.6|39.9|<0.001
73902977|NCT00718237|147336511|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|100.0|||<|0.001|TWO_SIDED|95.0|55.4|100.0||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||100.0|55.4|<0.001
73902978|NCT00251004|147336522|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|2.2||||0.001|TWO_SIDED|95.0|-2.9|7.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \<10%.||7.3|-2.9|0.001
73902979|NCT00251004|147336522|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in Percentage|0.3|||<|0.001|TWO_SIDED|95.0|-4.6|5.2||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \<10%.||5.2|-4.6|<0.001
73902980|NCT00251004|147336523|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|1.8||||0.014|TWO_SIDED|95.0|-5.5|9.1||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z - test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in percentage of participants composite efficacy failure is \<10%.||9.1|-5.5|0.014
73902981|NCT00251004|147336523|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|-3.8|||<|0.001|TWO_SIDED|95.0|-10.8|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in composite efficacy failure rates is \<10%.||3.3|-10.8|<0.001
73902982|NCT00251004|147336524|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at -8 mL/min/1.73m\^2.|Mean Difference (Net)|2.42|||<|0.001|TWO_SIDED|95.0|-1.6|6.5||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\^2 or more.||6.5|-1.6|<0.001
73902983|NCT00251004|147336524|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at -8 mL/min/1.73m\^2.|Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-4.9|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\^2 or more.||3.3|-4.9|<0.001
73902984|NCT00322153|147336525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.001|TWO_SIDED|95.0|1.0|4.2|||ANCOVA|Least-squares mean (-0.4 in placebo and 2.2 in memantine ER) are controlled for center and adjusted for SIB baseline value.||The co-primary efficacy parameter was change from Baseline to Week 24 in SIB total score. Missing SIB total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||4.2|1.0|0.001
73962176|NCT02528188|147460939|SUPERIORITY||Risk difference|0.1||||0.7182|TWO_SIDED|95.0|-0.74|1.52|||Exact methods for risk difference|||Primary osteonecrosis||1.52|-0.74|0.7182
73902985|NCT00322153|147336526|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|||The co-primary efficacy parameter was CIBIC-Plus total score at week 24. Missing CIBIC-Plus total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||||0.008
73962177|NCT02528188|147460939|SUPERIORITY||Risk difference|0.2||||0.6824|TWO_SIDED|95.0|-0.96|1.9|||Exact methods for risk difference|||Subchondral insufficiency fracture||1.90|-0.96|0.6824
73902986|NCT00322153|147336527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.177|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|Least-squares mean (-1.7 in placebo and -1.0 in memantine ER) are controlled for center and adjusted for ADCS-ADL19 baseline value.||The secondary efficacy parameter was change from Baseline at Week 24 in the total score of the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL19). Missing scores at week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||1.8|-0.3|0.177
73962178|NCT02528188|147460939|SUPERIORITY||Risk difference|0.3||||0.5632|TWO_SIDED|95.0|-0.86|2.03|||Exact methods for risk difference|||Subchondral insufficiency fracture||2.03|-0.86|0.5632
73962179|NCT02528188|147460940|SUPERIORITY||Rate Difference|19.56||||0.0027|TWO_SIDED|95.0|6.78|32.35|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2||32.35|6.78|0.0027
73852905|NCT01732510|147253519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.82||||0.015|TWO_SIDED|95.0|-16.87|-2.77|||Constrained longitudinal data analysis|||The reduction from baseline in EASI at week 12 for participants receiving MK-8226 3 mg/kg was compared to placebo (MK-8226 3 mg - Placebo). The constrained longitudinal data analysis model used variance component covariance matrix to model correlation among repeated visits, without adjustment for interaction of treatment group by visit.||-2.77|-16.87|0.015
73852906|NCT01178944|147253542|OTHER||Mean Difference (Final Values)|1.08||||0.585|TWO_SIDED|95.0|0.78|1.38|||t-test, 2 sided|||Comparison is CR+PR vs stable disease/progression||1.38|0.78|0.585
73852907|NCT00893152|147253543|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73852908|NCT01262560|147253544|SUPERIORITY_OR_OTHER|||||||0.92||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%).||Null hypothesis: Manuka honey in liquid form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect \>= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).||||0.92
73852909|NCT01262560|147253544|SUPERIORITY_OR_OTHER|||||||0.93||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%)||Null hypothesis: Manuka honey in lozenge form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect \>= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).||||0.93
73852910|NCT01262560|147253545|SUPERIORITY_OR_OTHER|||||||0.87|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.87
73852911|NCT01262560|147253545|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.46
73852912|NCT01262560|147253545|SUPERIORITY|||||||0.0023|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.0023
73852913|NCT01262560|147253545|SUPERIORITY|||||||0.0025|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0025
73852914|NCT01262560|147253545|SUPERIORITY||||||<|0.0001||||||Each explanatory variable is reported separately.|Mixed Models Analysis|||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||<0.0001
73962180|NCT02528188|147460940|SUPERIORITY||Rate Difference|51.48|||<|0.0001|TWO_SIDED|95.0|34.47|68.5|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2||68.50|34.47|<0.0001
73962181|NCT02528188|147460940|SUPERIORITY||Rate Difference|17.58||||0.0047|TWO_SIDED|95.0|5.39|29.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 1||29.76|5.39|0.0047
73962182|NCT02528188|147460940|SUPERIORITY||Rate Difference|38.22|||<|0.0001|TWO_SIDED|95.0|23.05|53.4|||Poisson model for rate difference|||Rapidly Progressive OA Type 1||53.40|23.05|<0.0001
73962183|NCT02528188|147460940|SUPERIORITY||Rate Difference|1.94||||0.3214|TWO_SIDED|95.0|-1.89|5.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 2||5.76|-1.89|0.3214
73962184|NCT02528188|147460940|SUPERIORITY||Rate Difference|12.88||||0.0008|TWO_SIDED|95.0|5.36|20.39|||Poisson model for rate difference|||Rapidly Progressive OA Type 2||20.39|5.36|0.0008
73962185|NCT02528188|147460940|SUPERIORITY||Rate Difference|1.9||||0.5394|TWO_SIDED|95.0|-4.17|7.96|||Poisson model for rate difference|||Subchondral Insufficiency Fracture||7.96|-4.17|0.5394
73962186|NCT02528188|147460940|SUPERIORITY||Rate Difference|2.98||||0.3636|TWO_SIDED|95.0|-3.44|9.39|||Poisson model for rate difference|||Subchondral Insufficiency Fracture||9.39|-3.44|0.3636
73962187|NCT02528188|147460940|SUPERIORITY||Poisson model for rate difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis||||
73962188|NCT02528188|147460940|SUPERIORITY||Rate Difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis||||
74024626|NCT01642212|147601645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 30% DSQ score reduction||||0.0206
74024627|NCT01642212|147601645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0275|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 50% DSQ score reduction||||0.0275
73852915|NCT01262560|147253546|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.70
73852916|NCT01262560|147253546|SUPERIORITY_OR_OTHER|||||||0.71|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.71
73852917|NCT01262560|147253546|SUPERIORITY|||||||0.0002|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.0002
73852918|NCT01262560|147253546|SUPERIORITY|||||||0.0051|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0051
73852919|NCT01262560|147253546|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||<0.0001
73852920|NCT01262560|147253547|SUPERIORITY_OR_OTHER|||||||0.086|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.086
73852921|NCT01262560|147253547|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.20
73852922|NCT01262560|147253547|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.44
73852923|NCT01262560|147253547|SUPERIORITY|||||||0.0066|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0066
73852924|NCT01262560|147253547|SUPERIORITY|||||||0.36|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||0.36
73852925|NCT01262560|147253547|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.94
73852926|NCT01262560|147253547|SUPERIORITY_OR_OTHER|||||||0.58|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.58
73902987|NCT00591578|147336528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.64|||<|0.001|TWO_SIDED|95.0|-5.59|-1.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-1.69|-5.59|<0.001
73962189|NCT02528188|147460941|SUPERIORITY||Risk Difference (RD)|4.87||||0.0002|TWO_SIDED|95.0|2.43|7.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Exact methods for risk difference|||||7.74|2.43|0.0002
73852927|NCT01262560|147253547|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.28
73852928|NCT01262560|147253547|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each exploratory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||<0.0001
73852929|NCT01262560|147253547|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||0.28
73852930|NCT01262560|147253548|SUPERIORITY_OR_OTHER|||||||0.06||||||Significance level = 0.05|Fisher Exact|||||||0.06
73852931|NCT01262560|147253548|SUPERIORITY_OR_OTHER|||||||0.31||||||Significance level = 0.05|Fisher Exact|||||||0.31
73852932|NCT01262560|147253549|SUPERIORITY_OR_OTHER|||||||0.53||||||significance level = 0.05|t-test, 2 sided|||||||0.53
73852933|NCT01262560|147253549|SUPERIORITY_OR_OTHER|||||||0.88||||||significance level = 0.05|t-test, 2 sided|||||||0.88
73852934|NCT01262560|147253550|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
73852935|NCT01262560|147253550|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
73852936|NCT01262560|147253553|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.||||0.39
73852937|NCT01262560|147253553|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.||||0.69
73852938|NCT00673231|147253572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.0726|<|0.0001|TWO_SIDED|95.0|-0.59|-0.31||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.31|-0.59|<0.0001
73852939|NCT00673231|147253572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.0718|<|0.0001|TWO_SIDED|95.0|-0.66|-0.38||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.38|-0.66|<0.0001
73852940|NCT00673231|147253572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.0733|<|0.0001|TWO_SIDED|95.0|-0.74|-0.45||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.45|-0.74|<0.0001
73852941|NCT00673231|147253573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.256||0.0001|TWO_SIDED|95.0|-1.5|-0.49||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.49|-1.50|0.0001
73852942|NCT00673231|147253573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2523|<|0.0001|TWO_SIDED|95.0|-1.5|-0.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.50|-1.50|<0.0001
73962190|NCT02528188|147460941|SUPERIORITY||Risk Difference (RD)|9.41|||<|0.0001|TWO_SIDED|95.0|6.73|12.52|||Exact methods for risk difference|||||12.52|6.73|<0.0001
74024628|NCT01642212|147601646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|TWO_SIDED||||||Fisher Exact|||Analysis of response and \>/= 30% DSQ score reduction||||0.0026
74024629|NCT01642212|147601646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0199|TWO_SIDED||||||Fisher Exact|||Analysis of response and \>/= 50% DSQ score reduction||||0.0199
74024630|NCT01642212|147601647|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-22.34|||<|0.0001|TWO_SIDED|95.0|-30.345|-14.334|||ANCOVA|LS mean based on the ANCOVA model including treatment group as a factor and baseline as a covariate.||||-14.334|-30.345|<0.0001
74024631|NCT01642212|147601648|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.76|||<|0.0001|TWO_SIDED|95.0|-5.172|-2.358||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||||-2.358|-5.172|<0.0001
74024632|NCT01642212|147601649|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-35.5||||0.0002|TWO_SIDED|95.0|-53.438|-17.57||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of proximal eosinophil count||-17.570|-53.438|0.0002
74024633|NCT01642212|147601649|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-59.56|||<|0.0001|TWO_SIDED|95.0|-84.173|-34.948||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of mid- eosinophil count||-34.948|-84.173|<0.0001
74024634|NCT01642212|147601649|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-67.38|||<|0.0001|TWO_SIDED|95.0|-93.573|-41.18||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of distal eosinophil count||-41.180|-93.573|<0.0001
74024635|NCT01642212|147601650|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-18.44||||0.0015|TWO_SIDED|95.0|-29.593|-7.293||LS mean estimates were based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||||-7.293|-29.593|0.0015
74024636|NCT01642212|147601651|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117|TWO_SIDED|||||P-value for comparison of the treatment difference was determined by Cochran-Mantel-Haenszel row mean score test.|Cochran-Mantel-Haenszel|||Analysis of distribution of scores across all responses||||0.1170
74024637|NCT01642212|147601652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1947|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of heartburn||||0.1947
73852943|NCT00673231|147253573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.2578|<|0.0001|TWO_SIDED|95.0|-2.19|-1.18||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-1.18|-2.19|<0.0001
73852944|NCT00673231|147253574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.87|STANDARD_ERROR_OF_MEAN|1.3195|<|0.0001|TWO_SIDED|95.0|-9.46|-4.28||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-4.28|-9.46|<0.0001
73852945|NCT00673231|147253574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69|STANDARD_ERROR_OF_MEAN|1.3045|<|0.0001|TWO_SIDED|95.0|-8.25|-3.13||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-3.13|-8.25|<0.0001
74024638|NCT01642212|147601652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8029|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of chest pain||||0.8029
74024639|NCT01642212|147601652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4963|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of regurgitation||||0.4963
74024640|NCT01642212|147601652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5257|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of abdominal pain||||0.5257
74024641|NCT01642212|147601652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5219|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of nausea||||0.5219
74024642|NCT01642212|147601652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2886|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of vomiting||||0.2886
74024643|NCT01642212|147601655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. Both responses (no change, worsened) were analyzed collectively.|Cochran-Mantel-Haenszel|||Analysis of symptoms of participants with no symptoms at baseline||||0.1600
74024644|NCT01642212|147601657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 30% DSQ+pain score reduction||||0.0606
74024645|NCT01642212|147601657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 50% DSQ+pain score reduction||||0.0165
74024646|NCT01642212|147601658|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7817|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7817
73852946|NCT00673231|147253574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.3286|<|0.0001|TWO_SIDED|95.0|-8.84|-3.63||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-3.63|-8.84|<0.0001
73852947|NCT00673231|147253575|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.2|STANDARD_ERROR_OF_MEAN|3.536||0.0427|TWO_SIDED|95.0|0.2|14.1||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||14.1|0.2|0.0427
73852948|NCT00673231|147253575|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|3.434||0.0903|TWO_SIDED|95.0|-0.9|12.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||12.5|-0.9|0.0903
73852949|NCT00673231|147253575|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.7|STANDARD_ERROR_OF_MEAN|3.634||0.0166|TWO_SIDED|95.0|1.6|15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||15.8|1.6|0.0166
73852950|NCT00673231|147253576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.8|STANDARD_ERROR_OF_MEAN|4.684||0.0008|TWO_SIDED|95.0|-25.0|-6.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-6.6|-25.0|0.0008
73852951|NCT00673231|147253576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|4.616|||TWO_SIDED|95.0|-31.2|-13.1||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-13.1|-31.2|
73852952|NCT00673231|147253576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|STANDARD_ERROR_OF_MEAN|4.718|<|0.0001|TWO_SIDED|95.0|-34.3|-15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-15.8|-34.3|<0.0001
73852953|NCT03594747|147253584|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.0001|TWO_SIDED|95.0|0.37|0.74|||One-sided stratified log-rank test|||||0.74|0.37|0.0001
73852954|NCT03594747|147253584|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.67|||One-sided stratified log-rank test|||||0.67|0.33|<0.0001
73852955|NCT03594747|147253585|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.32|0.61||||||||0.61|0.32|
73852956|NCT03594747|147253585|SUPERIORITY||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.3|0.59||||||||0.59|0.30|
73852957|NCT05926544|147253694|SUPERIORITY||Risk Ratio (RR)|0.46|||||TWO_SIDED|95.0|0.18|1.16|||||The Standard implementation arm was the reference group.|||1.16|0.18|
73852958|NCT03522246|147253695|SUPERIORITY|Rucaparib vs Placebo|Hazard Ratio (HR)|0.47||||0.0004|TWO_SIDED|95.0|0.31|0.72|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification and timing of surgery.|||0.72|0.31|0.0004
73852959|NCT03522246|147253696|SUPERIORITY|Rucaparib vs Placebo|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification, disease status post-chemotherapy, and timing of surgery.|||0.68|0.40|<0.0001
73852960|NCT03522246|147253697|SUPERIORITY|Rucaparib + Nivolumab vs Rucaparib + Placebo|Hazard Ratio (HR)|1.29||||0.0038|TWO_SIDED|95.0|1.08|1.53|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification, disease status post-chemotherapy, and timing of surgery.|||1.53|1.08|0.0038
73852961|NCT04683029|147253710|SUPERIORITY||LS Mean Difference|-12.6|||<|0.001|TWO_SIDED|80.0|-13.8|-11.4|||MMRM model|||||-11.4|-13.8|< 0.001
73852962|NCT04683029|147253711|SUPERIORITY||LS Mean Difference|-12.0|||||TWO_SIDED|80.0|-13.3|-10.7||||||||-10.7|-13.3|
73852963|NCT04683029|147253712|SUPERIORITY||Odds Ratio (OR)|0.1|||||TWO_SIDED|80.0|0.0|0.3||||||Week 24||0.3|0.0|
73852964|NCT04683029|147253712|SUPERIORITY||Odds Ratio (OR)|0.1|||||TWO_SIDED|80.0|0.0|0.2||||||Week 52||0.2|0.0|
73852965|NCT04683029|147253713|SUPERIORITY||Odds Ratio (OR)|203.2|||||TWO_SIDED|80.0|42.1|980.6||||||Week 24||980.6|42.1|
73852966|NCT04683029|147253713|SUPERIORITY||Odds Ratio (OR)|130.3|||||TWO_SIDED|80.0|28.2|601.9||||||Week 52||601.9|28.2|
73852967|NCT04683029|147253714|SUPERIORITY||LS Mean Difference|-47.2|||||TWO_SIDED|80.0|-96.8|2.4||||||Week 24||2.4|-96.8|
73852968|NCT04683029|147253714|SUPERIORITY||LS Mean difference|-14.2|||||TWO_SIDED|80.0|-57.2|28.8||||||Week 52||28.8|-57.2|
73852969|NCT04683029|147253715|SUPERIORITY||LS Mean Difference|0.0|||||TWO_SIDED|80.0|-1.7|1.6||||||Week 24||1.6|-1.7|
73852970|NCT04683029|147253715|SUPERIORITY||LS Mean Difference|0.1|||||TWO_SIDED|80.0|-1.4|1.7||||||Week 52||1.7|-1.4|
73852971|NCT04683029|147253716|SUPERIORITY||LS Mean Difference|-0.08|||||TWO_SIDED|80.0|-0.44|0.27||||||Week 24||0.27|-0.44|
73852972|NCT04683029|147253716|SUPERIORITY||LS Mean Difference|0.21|||||TWO_SIDED|80.0|-0.29|0.71||||||Week 52||0.71|-0.29|
73962191|NCT02528188|147460942|SUPERIORITY||Rate Difference|48.25|||<|0.0001|TWO_SIDED|95.0|26.76|69.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Poisson model for rate difference|||||69.74|26.76|<0.0001
73962192|NCT02528188|147460942|SUPERIORITY||Rate Difference|95.83|||<|0.0001|TWO_SIDED|95.0|70.25|121.42|||Poisson model for rate difference|||||121.42|70.25|<0.0001
73962193|NCT02528188|147460943|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0979|TWO_SIDED|95.0|-0.15|0.01|||ANCOVA|||Change in medial JSW width at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.01|-0.15|0.0979
73962194|NCT02528188|147460943|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||ANCOVA|||Change in medial JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.08|-0.24|<0.0001
73962195|NCT02528188|147460943|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1162|TWO_SIDED|95.0|-0.17|0.02|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.02|-0.17|0.1162
73852973|NCT04683029|147253717|SUPERIORITY||LS Mean Difference|-2.08|||||TWO_SIDED|80.0|-3.81|-0.34||||||Week 24||-0.34|-3.81|
73852974|NCT04683029|147253717|SUPERIORITY||LS Mean Difference|0.14|||||TWO_SIDED|80.0|-2.13|2.42||||||Week 52||2.42|-2.13|
73852975|NCT04683029|147253718|SUPERIORITY||LS Mean Difference|-4.9|||||TWO_SIDED|80.0|-5.7|-4.0||||||Week 24||-4.0|-5.7|
73852976|NCT04683029|147253718|SUPERIORITY||LS Mean Difference|-4.3|||||TWO_SIDED|80.0|-5.1|-3.5||||||Week 52||-3.5|-5.1|
73962196|NCT02528188|147460943|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0128|TWO_SIDED|95.0|-0.22|-0.03|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.03|-0.22|0.0128
73962197|NCT02528188|147460943|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.8885|TWO_SIDED|95.0|-0.17|0.2|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.20|-0.17|0.8885
73962198|NCT02528188|147460943|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6345|TWO_SIDED|95.0|-0.24|0.15|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.15|-0.24|0.6345
73962199|NCT02528188|147460943|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4406|TWO_SIDED|95.0|-0.32|0.14|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.14|-0.32|0.4406
73962200|NCT02528188|147460943|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.12||0.7109|TWO_SIDED|95.0|-0.19|0.28|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.28|-0.19|0.7109
73852977|NCT04683029|147253719|SUPERIORITY||LS Mean Difference|-0.4006|||||TWO_SIDED|80.0|-0.5344|-0.2668||||||Week 24||-0.2668|-0.5344|
73852978|NCT04683029|147253719|SUPERIORITY||LS Mean Difference|-0.2355|||||TWO_SIDED|80.0|-0.373|-0.098||||||Week 52||-0.0980|-0.3730|
73852979|NCT00814580|147253730|NON_INFERIORITY_OR_EQUIVALENCE|Primary hypothesis test for non-inferiority of tapentadol IR over oxycodone IR required that upper limit of 95% CI for LS mean difference (oxycodone IR minus tapentadol IR) was less than the inferiority margin (\< 72). If the upper limit was less than 0 then tapentadol IR was superior to oxycodone IR for SPID over 3 days at a 5% level of significance.|Least square mean difference|9.0|STANDARD_ERROR_OF_MEAN|14.2||0.5265|TWO_SIDED|95.0|-18.9|36.9||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||Tapentadol IR versus Oxycodone IR||36.9|-18.9|0.5265
73852980|NCT00814580|147253731|SUPERIORITY_OR_OTHER|||||||0.7306||95.0|||||Log Rank|||||||0.7306
73852981|NCT00814580|147253732|SUPERIORITY_OR_OTHER|||||||0.8524||95.0|||||Log Rank|||||||0.8524
73852982|NCT00814580|147253733|SUPERIORITY_OR_OTHER|||||||0.9078||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.9078
73852983|NCT00814580|147253734|SUPERIORITY_OR_OTHER|||||||0.2633||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.2633
73852984|NCT00814580|147253735|SUPERIORITY_OR_OTHER|||||||0.4498||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.4498
73852985|NCT00814580|147253736|SUPERIORITY_OR_OTHER|||||||0.2158||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.2158
73962201|NCT02528188|147460944|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.102|TWO_SIDED|95.0|-0.3|0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.03|-0.30|0.1020
73852986|NCT00814580|147253737|SUPERIORITY_OR_OTHER||Least square mean difference|6.6|STANDARD_ERROR_OF_MEAN|9.34||0.4811|TWO_SIDED|95.0|-11.8|25.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||25.0|-11.8|0.4811
73852987|NCT00814580|147253738|SUPERIORITY_OR_OTHER||Least square mean difference|-9.3|STANDARD_ERROR_OF_MEAN|28.13||0.7405|TWO_SIDED|95.0|-64.7|46.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||46.0|-64.7|0.7405
73852988|NCT00814580|147253739|SUPERIORITY_OR_OTHER||Least square mean difference|-5.6|STANDARD_ERROR_OF_MEAN|5.53||0.3097|TWO_SIDED|95.0|-16.5|5.3||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||5.3|-16.5|0.3097
73962202|NCT02528188|147460944|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.023|TWO_SIDED|95.0|-0.35|-0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.03|-0.35|0.0230
73962203|NCT02528188|147460944|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0645|TWO_SIDED|95.0|-0.37|0.01|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.01|-0.37|0.0645
73852989|NCT00814580|147253740|SUPERIORITY_OR_OTHER||Least square mean difference|-10.3|STANDARD_ERROR_OF_MEAN|8.34||0.2179|TWO_SIDED|95.0|-26.7|6.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||6.1|-26.7|0.2179
73852990|NCT00814580|147253741|SUPERIORITY_OR_OTHER||Least square mean difference|-26.3|STANDARD_ERROR_OF_MEAN|16.16||0.1051|TWO_SIDED|95.0|-58.1|5.5||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||5.5|-58.1|0.1051
73852991|NCT00814580|147253742|SUPERIORITY_OR_OTHER||Least square mean difference|1.0|STANDARD_ERROR_OF_MEAN|12.09||0.9367|TWO_SIDED|95.0|-22.8|24.8||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||24.8|-22.8|0.9367
73852992|NCT00814580|147253743|SUPERIORITY_OR_OTHER||Least square mean difference|-1.3|STANDARD_ERROR_OF_MEAN|18.53||0.9441|TWO_SIDED|95.0|-37.8|35.2||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||35.2|-37.8|0.9441
73962204|NCT02528188|147460944|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.5005|TWO_SIDED|95.0|-0.26|0.13|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.13|-0.26|0.5005
73962205|NCT02528188|147460945|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0358|TWO_SIDED|95.0|1.04|3.29|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||3.29|1.04|0.0358
73962206|NCT02528188|147460945|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0021|TWO_SIDED|95.0|1.37|4.12|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||4.12|1.37|0.0021
73962207|NCT02528188|147460945|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0301|TWO_SIDED|95.0|1.07|3.77|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||3.77|1.07|0.0301
73962208|NCT02528188|147460945|SUPERIORITY||Odds Ratio (OR)|2.65||||0.0016|TWO_SIDED|95.0|1.45|4.85|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||4.85|1.45|0.0016
73962209|NCT02528188|147460945|SUPERIORITY||Odds Ratio (OR)|0.55||||0.3002|TWO_SIDED|95.0|0.18|1.7|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||1.70|0.18|0.3002
73962210|NCT02528188|147460945|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8997|TWO_SIDED|95.0|0.39|2.89|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||2.89|0.39|0.8997
73962211|NCT02528188|147460945|SUPERIORITY||Odds Ratio (OR)|1.48||||0.4559|TWO_SIDED|95.0|0.53|4.18|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||4.18|0.53|0.4559
73962212|NCT02528188|147460945|SUPERIORITY||Odds Ratio (OR)|0.71||||0.5996|TWO_SIDED|95.0|0.2|2.54|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||2.54|0.20|0.5996
73962213|NCT02528188|147460946|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0714|TWO_SIDED|95.0|0.9|12.65|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate||12.65|0.90|0.0714
73962214|NCT02528188|147460946|SUPERIORITY||Odds Ratio (OR)|3.42||||0.0681|TWO_SIDED|95.0|0.91|12.84|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate||12.84|0.91|0.0681
73962215|NCT02528188|147460946|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0967|TWO_SIDED|95.0|0.81|11.95|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate||11.95|0.81|0.0967
73962216|NCT02528188|147460946|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0976|TWO_SIDED|95.0|0.81|11.9|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate||11.90|0.81|0.0976
73962217|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.2212|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.27|0.2212
73962218|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.08||0.4557|TWO_SIDED|95.0|-0.1|0.23|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.10|0.4557
73962219|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.09||0.0029|TWO_SIDED|95.0|-0.45|-0.09|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.09|-0.45|0.0029
73962220|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.5|-0.14|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.50|0.0005
73962221|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.09||0.1273|TWO_SIDED|95.0|-0.33|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.33|0.1273
73852993|NCT00814580|147253744|SUPERIORITY_OR_OTHER||Least square mean difference|-35.6|STANDARD_ERROR_OF_MEAN|37.45||0.3427|TWO_SIDED|95.0|-109.3|38.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||38.1|-109.3|0.3427
73902988|NCT00591578|147336528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03|||<|0.001|TWO_SIDED|95.0|-6.01|-2.06||Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-2.06|-6.01|<0.001
73902989|NCT00591578|147336529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27||||0.015|TWO_SIDED|95.0|-5.9|-0.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.63|-5.90|0.015
73962222|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.57|-0.2|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-0.57|<0.0001
73962223|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.6349|TWO_SIDED|95.0|-0.31|0.19|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.31|0.6349
73852994|NCT00814580|147253745|SUPERIORITY_OR_OTHER|||||||0.1618||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.1618
73852995|NCT00814580|147253746|SUPERIORITY_OR_OTHER|||||||0.0481||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.0481
73852996|NCT00814580|147253747|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers|Cochran-Mantel-Haenszel|||||||0.0109
73852997|NCT02482428|147253764|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.07||0.862|TWO_SIDED|90.0|-0.03|0.2|||Posterior mean|||||0.20|-0.03|0.862
73852998|NCT02482428|147253764|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.07||0.541|TWO_SIDED|90.0|-0.07|0.19|||posterior mean|||||0.19|-0.07|0.541
73852999|NCT00335283|147253772|SUPERIORITY_OR_OTHER||Odds Ratio, log|3.12||||0.01|TWO_SIDED|95.0|1.28|7.59|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||7.59|1.28|.01
73853000|NCT00335283|147253772|SUPERIORITY_OR_OTHER||Odds Ratio, log|3.5||||0.006|TWO_SIDED|95.0|1.41|8.67|||Regression, Logistic|||This applies to the 16 week treatment affect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||8.67|1.41|.006
73853001|NCT00335283|147253773|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.01||||0.97|TWO_SIDED|95.0|0.38|2.7|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||2.70|0.38|.97
73853002|NCT00335283|147253773|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.11||||0.84|TWO_SIDED|95.0|0.4|3.06|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||3.06|0.40|.84
73853003|NCT00335283|147253774|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.44||||0.06|TWO_SIDED|95.0|0.95|6.31|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||6.31|.95|.06
73853004|NCT00335283|147253774|SUPERIORITY_OR_OTHER||Odds Ratio, log|4.51||||0.007|TWO_SIDED|95.0|1.5|13.6|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||13.6|1.5|.007
73853005|NCT00335283|147253775|SUPERIORITY_OR_OTHER||Odds Ratio, log|5.17||||0.006|TWO_SIDED|95.0|2.02|13.2|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||13.2|2.02|.006
73902990|NCT00591578|147336529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.34|||<|0.001|TWO_SIDED|95.0|-8.0|-2.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-2.68|-8.00|<0.001
73902991|NCT00591578|147336530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|||<|0.001|TWO_SIDED|95.0|-3.44|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.88|-3.44|<0.001
73902992|NCT00591578|147336530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||<|0.001|TWO_SIDED|95.0|-3.99|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.40|-3.99|<0.001
73902993|NCT00591578|147336531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52||||0.001|TWO_SIDED|95.0|-4.06|-0.98||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.98|-4.06|0.001
73902994|NCT00591578|147336531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76|||<|0.001|TWO_SIDED|95.0|-4.32|-1.21||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.21|-4.32|<0.001
73962224|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.13||0.1339|TWO_SIDED|95.0|-0.44|0.06|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.44|0.1339
73962225|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.6237|TWO_SIDED|95.0|-0.33|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.33|0.6237
73962226|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4224|TWO_SIDED|95.0|-0.37|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.37|0.4224
73962227|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7526|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7526
73962228|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.13||0.7328|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7328
73962229|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.5888|TWO_SIDED|95.0|-0.33|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.33|0.5888
73962230|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.9345|TWO_SIDED|95.0|-0.28|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.26|-0.28|0.9345
73962231|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8782|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.29|0.8782
73971037|NCT05034328|147482257|SUPERIORITY||Hazard Ratio (HR)|1.153||||0.3954|TWO_SIDED|95.0|0.83|1.601|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.601|0.830|0.3954
73971038|NCT05034328|147482258|SUPERIORITY||Hazard Ratio (HR)|1.218||||1.218|TWO_SIDED|95.0|0.871|1.703|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.703|0.871|1.218
73902995|NCT00591578|147336532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49|||<|0.001|TWO_SIDED|95.0|-5.53|-1.44||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.44|-5.53|<0.001
73902996|NCT00591578|147336532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.96|-1.83||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.83|-5.96|<0.001
73902997|NCT00591578|147336533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17||||0.002|TWO_SIDED|95.0|-3.54|-0.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.79|-3.54|0.002
73902998|NCT00591578|147336533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67|||<|0.001|TWO_SIDED|95.0|-4.06|-1.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.28|-4.06|<0.001
73962232|NCT02528188|147460947|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7076|TWO_SIDED|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.32|-0.22|0.7076
73853006|NCT00335283|147253775|SUPERIORITY_OR_OTHER||Odds Ratio, log|5.31||||0.001|TWO_SIDED|95.0|1.97|14.3|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||14.3|1.97|.001
73853007|NCT01951586|147253825|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5157|TWO_SIDED|95.0|0.81|1.53|||Log Rank|Log rank test stratified by the randomization stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio \< 1 favors denosumab."|||1.53|0.81|0.5157
73853008|NCT01951586|147253826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3759|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3759
73853009|NCT01951586|147253826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3666|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3666
73853010|NCT01951586|147253826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1917|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.1917
73853011|NCT01951586|147253826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3353|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3353
73853012|NCT01951586|147253826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3179|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3179
73853013|NCT01951586|147253826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1583|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.1583
73853014|NCT01951586|147253827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3946|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.3946
73853015|NCT01951586|147253827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3735|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.3735
73962233|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.015|TWO_SIDED|95.0|-0.37|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.04|-0.37|0.0150
73962234|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3286|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.25|0.3286
73962235|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|-0.5|-0.15|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.50|0.0004
73962236|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09||0.0001|TWO_SIDED|95.0|-0.53|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.53|0.0001
73971039|NCT05034328|147482259|SUPERIORITY||||||>|0.05|||||||Regression, Logistic|||The impact of the treatment chosen on the risk to develop respiratory complication requiring antibiotic prescription during a 20-day follow-up was analyzed by a multivariate logistic model||||>0.05
73971040|NCT05034328|147482260|SUPERIORITY||Odds Ratio (OR)|0.335||||0.001|TWO_SIDED|95.0|0.174|0.644|||Regression, Logistic|||||0.644|0.174|0.0010
74024647|NCT01642212|147601659|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.1686|TWO_SIDED|95.0|-0.222|0.04||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||0.040|-0.222|0.1686
74024648|NCT01642212|147601659|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03||||0.8046|TWO_SIDED|95.0|-0.269|0.21||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||0.210|-0.269|0.8046
74024649|NCT01642212|147601659|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01||||0.9239|TWO_SIDED|95.0|-0.199|0.219||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16||0.219|-0.199|0.9239
74024650|NCT01642212|147601660|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73||||0.4835|TWO_SIDED|95.0|-2.806|1.339||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||1.339|-2.806|0.4835
74024651|NCT01642212|147601660|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.92||||0.0662|TWO_SIDED|95.0|-3.974|0.132||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||0.132|-3.974|0.0662
74024652|NCT01642212|147601660|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.8||||0.1091|TWO_SIDED|95.0|-4.006|0.41||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16||0.410|-4.006|0.1091
74024653|NCT01696461|147601705|OTHER||||||||||||||||||Percentage of donors mobilized with plerixafor. No comparison group was analyzed.|||
74024654|NCT01696461|147601706|OTHER||||||||||||||||||This is a descriptive analysis. Percentage of donor experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3. Grade of maximum toxicity across all time points is reported.|||
73853016|NCT01951586|147253828|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.3491|TWO_SIDED|95.0|0.43|1.35|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.|||1.35|0.43|0.3491
73853017|NCT01951586|147253829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.476|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.4760
73853018|NCT01951586|147253829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2582|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2582
73853019|NCT01951586|147253829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2230
73853020|NCT01951586|147253829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4329|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.4329
73853021|NCT01951586|147253829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2620
73853022|NCT01951586|147253829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2081|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2081
73853023|NCT01951586|147253830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4671|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.4671
73853024|NCT01951586|147253830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4236|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.4236
73853025|NCT01951586|147253831|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81||||0.4654|TWO_SIDED|95.0|0.46|1.43|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.|||1.43|0.46|0.4654
73853026|NCT01951586|147253832|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.7363|TWO_SIDED|95.0|0.78|1.43|||Log Rank|Log rank test stratified by the randomized stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio \< 1 favors denosumab."|||1.43|0.78|0.7363
73853027|NCT02277691|147253865|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 12 (LOCF).||||<0.0001
73853028|NCT02277691|147253865|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 52 (LOCF).||||<0.0001
74024655|NCT01696461|147601707|OTHER||||||||||||||||||This is a descriptive analysis. The number of donors experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and one, six, and 12 months post-donation. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3.|||
73853029|NCT02277691|147253865|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 12 (LOCF).||||<0.0001
73853030|NCT02277691|147253865|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 52 (LOCF).||||<0.0001
73853031|NCT02277691|147253866|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at End of Week 12.||||<0.0001
73853032|NCT02277691|147253866|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at EOT (Up to Week 52).||||<0.0001
73853033|NCT02277691|147253866|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at End of Week 12.||||<0.0001
73853034|NCT02277691|147253866|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at EOT (Up to Week 52).||||<0.0001
73853035|NCT01864148|147253963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9584|TWO_SIDED|95.0|0.46|2.07|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.07|0.46|0.9584
73853036|NCT01864148|147253963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0636|TWO_SIDED|95.0|0.97|3.31|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||3.31|0.97|0.0636
73853037|NCT01864148|147253963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.022|TWO_SIDED|95.0|1.11|3.84|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||3.84|1.11|0.0220
73853038|NCT01864148|147253963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1771|TWO_SIDED|95.0|0.36|1.21|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.21|0.36|0.1771
73853039|NCT01864148|147253963|SUPERIORITY_OR_OTHER|||||||0.8931|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.||||||0.8931
73853040|NCT01864148|147253964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.3058|TWO_SIDED|95.0|0.28|1.49|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.49|0.28|0.3058
73853041|NCT01864148|147253964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.1873|TWO_SIDED|95.0|0.81|2.89|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.89|0.81|0.1873
73853042|NCT01864148|147253964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.2766|TWO_SIDED|95.0|0.76|2.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.65|0.76|0.2766
73853043|NCT01864148|147253964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6578|TWO_SIDED|95.0|0.45|1.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.65|0.45|0.6578
73853044|NCT01864148|147253964|SUPERIORITY_OR_OTHER|||||||0.5255|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.||||||0.5255
73853045|NCT02027311|147253967|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0||||For two-sided tests, p \< 0.05 was considered statistically significant.|Regression, Logistic|Logistic regression model used to identify the factors related to the presence of intervention (frequency of intervention = 0, vs. ≥ 1).||If the true difference in the experimental and control means is 4, total 26 experimental subjects and 26 control subjects was required to reject the null hypothesis that the means of the primary outcome values of experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.||||0.05
73853046|NCT02027311|147253968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.09||||0.002|TWO_SIDED|95.0|2.41|50.94||Logistic regression model were used in univariate and corrected multivariate analyses to identify the factors related to the primary outcome variables, such as, presence of intervention (frequency of intervention = 0, vs. ≥ 1).|Regression, Logistic|||All the continuous variables were compared using the Mann-Whitney U test and dichotomous categorical variables was used and the Pearson chi-square with Fisher exact test. We used the linear mixed model to compare the differences of paired data, such as mean values of RR, SpO2, MAP, HR, and RSS at different time points of the two different sedation groups. For two-sided tests, p \< 0.05 was considered statistically significant.||50.94|2.41|0.002
73853047|NCT01825512|147253969|NON_INFERIORITY|Deferiprone was declared non inferior to Deferasirox if the lower limit of the 95% confidence interval for the difference in the proportion of successful chelation in the two groups is above -12.5%.|Treatment success rate|-12.5|||||ONE_SIDED|95.0|-12.5||||||||||-12.5|
73853048|NCT01825512|147253970|OTHER|GLM model|Mean Difference (Final Values)|2.128|STANDARD_ERROR_OF_MEAN|1.18||0.074|TWO_SIDED|95.0|-0.213|4.468|||ANCOVA|||||4.468|-0.213|0.074
73853049|NCT01825512|147253971|OTHER|GLM Analysis|Mean Difference (Final Values)|-0.633|STANDARD_ERROR_OF_MEAN|1.741||0.717|TWO_SIDED|95.0|-4.085|2.819|||ANCOVA|||||2.819|-4.085|0.717
73853050|NCT01825512|147253972|NON_INFERIORITY|Non inferiority of Deferiprone to Deferasirox is tested considering a non-inferiority margin of 400 ng/mL.|Mean Difference (Final Values)|0.601|STANDARD_ERROR_OF_MEAN|164.734||0.997|TWO_SIDED|95.0|-323.58|324.781|||GLM|||||324.781|-323.580|0.997
73853051|NCT02466425|147253973|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-9.9|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|-13.0|-6.8|||Mixed-effects model for repeated measure||Between treatment groups|||-6.8|-13.0|<0.001
73853052|NCT03231917|147253999|OTHER|||||||0.48|||||||Chi-squared|||||||0.48
73853053|NCT01901289|147254012|OTHER||Cumulative Probability|0.927|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.881|0.956|||||The estimate of the variance of the Kaplan-Meier estimate used the methods described by Peto et al.|||0.956|0.881|
73853054|NCT01813058|147254013|SUPERIORITY||Mean Difference (Final Values)|195.0|||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73853055|NCT00361231|147254028|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kaplan-Meier|||||||<0.05
73853056|NCT00361231|147254029|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
73853057|NCT00313144|147254042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Paired t-test|||||||0.044
73853058|NCT00313144|147254044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Paired t-test|||||||0.009
73853059|NCT00313144|147254045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Paired t-test|||||||0.005
73853060|NCT00313144|147254047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||Paired t-test|||||||0.006
73853061|NCT00313144|147254048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Paired t-test|||||||0.044
73853062|NCT00313144|147254049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0|||||Paired t-test|||||||0.046
73853063|NCT00744380|147254076|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
73853064|NCT00744380|147254077|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||For open label midazolam||||0.25
73853065|NCT00744380|147254077|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||For all midazolam||||0.048
73853066|NCT00744380|147254077|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||For fentanyl||||0.88
73853067|NCT00744380|147254078|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared, Corrected|||For Riker scores||||0.75
73853068|NCT00744380|147254078|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||For pain scores||||0.17
73853069|NCT00744380|147254079|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Chi-squared, Corrected|||For hypotension||||>0.1
73853070|NCT00744380|147254079|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Chi-squared, Corrected|||For bradycardia||||>0.1
73853071|NCT00744380|147254079|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Fisher Exact|||For tachycardia||||>0.1
73853072|NCT00744380|147254079|SUPERIORITY_OR_OTHER|||||||0.07|||||||Fisher Exact|||For delirium, new onset||||0.07
73853073|NCT00744380|147254080|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Median number of experiences remembered||||0.015
73853074|NCT00744380|147254081|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
73853075|NCT00744380|147254082|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
73853076|NCT00744380|147254083|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 2 sided|||For anxiety||||>0.1
73853077|NCT00744380|147254083|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 2 sided|||For depression||||>0.1
73853078|NCT01932372|147254085|OTHER||Incidence rate ratio (unadjusted)|4.85|||||TWO_SIDED|95.0|3.34|7.03||||||||7.03|3.34|
73853079|NCT01932372|147254085|OTHER||Hazard ratio (unadjusted)|4.8|||||TWO_SIDED|95.0|3.31|6.96||||||||6.96|3.31|
73853080|NCT01932372|147254085|OTHER||Hazard ratio (adjusted 1)|2.07|||||TWO_SIDED|95.0|0.95|4.51||||||||4.51|0.95|
73853081|NCT01932372|147254085|OTHER||Hazard ratio (adjusted 2)|3.81|||||TWO_SIDED|95.0|2.24|6.47||||||||6.47|2.24|
73853082|NCT01932372|147254085|OTHER||Hazard ratio (adjusted 3)|3.55|||||TWO_SIDED|95.0|2.08|6.09||||||||6.09|2.08|
73853083|NCT01932372|147254085|OTHER||Hazard ratio (adjusted 4)|3.8|||||TWO_SIDED|95.0|2.31|6.25||||||||6.25|2.31|
73853084|NCT01932372|147254086|OTHER||Incidence rate ratio (unadjusted)|1.6|||||TWO_SIDED|95.0|1.16|2.19||||||||2.19|1.16|
73853085|NCT01932372|147254086|OTHER||Hazard ratio (unadjusted)|1.55|||||TWO_SIDED|95.0|1.12|2.13||||||||2.13|1.12|
73853086|NCT01932372|147254086|OTHER||Hazard ratio (adjusted 1)|1.86|||||TWO_SIDED|95.0|1.16|2.99||||||||2.99|1.16|
73853087|NCT01932372|147254086|OTHER||Hazard ratio (adjusted 2)|1.61|||||TWO_SIDED|95.0|1.06|2.43||||||||2.43|1.06|
73853088|NCT01932372|147254086|OTHER||Hazard ratio (adjusted 3)|1.53|||||TWO_SIDED|95.0|1.0|2.35||||||||2.35|1.00|
73853089|NCT01932372|147254086|OTHER||Hazard ratio (adjusted 4)|1.51|||||TWO_SIDED|95.0|1.03|2.22||||||||2.22|1.03|
73853090|NCT01932372|147254087|OTHER||Mortality rate ratio (unadjusted)|3.39|||||TWO_SIDED|95.0|1.99|5.78||||||||5.78|1.99|
73853091|NCT01932372|147254087|OTHER||Hazard ratio (unadjusted)|3.29|||||TWO_SIDED|95.0|1.93|5.61||||||||5.61|1.93|
73853092|NCT02907216|147254113|NON_INFERIORITY|Criteria for non-inferiority: The Lower Limit (LL) of the standardised asymptotic 95% Confidence Interval (CI) on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-D antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||TWO_SIDED|95.0|-2.66|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-D antibody concentration ≥ 0.1 IU/mL.||2.74|-2.66|
73902999|NCT00591578|147336534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.79|||<|0.001|TWO_SIDED|95.0|-5.96|-1.62||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.62|-5.96|<0.001
73903000|NCT00591578|147336534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||<|0.001|TWO_SIDED|95.0|-6.63|-2.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-2.24|-6.63|<0.001
73903001|NCT00591578|147336535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.008|TWO_SIDED|95.0|-3.48|-0.53||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.53|-3.48|0.008
73903002|NCT00591578|147336535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.84|||<|0.001|TWO_SIDED|95.0|-4.33|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.35|-4.33|<0.001
73903003|NCT00591578|147336536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44||||0.002|TWO_SIDED|95.0|-5.57|-1.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.30|-5.57|0.002
73903004|NCT00591578|147336536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.01|||<|0.001|TWO_SIDED|95.0|-6.16|-1.85||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.85|-6.16|<0.001
73853093|NCT02907216|147254113|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-T antibodies should be ≥ -10%.|Difference-Seroprotective concentration|-0.69|||||TWO_SIDED|95.0|-4.39|2.71|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-T antibody concentration ≥ 0.1 IU/mL.||2.71|-4.39|
73853094|NCT02907216|147254114|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-PT antibodies should be ≥ -10%.|Difference-Seroprotective concentration|2.99|||||TWO_SIDED|95.0|-2.7|9.12|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-PT antibody concentration ≥ 10 IU/mL.||9.12|-2.7|
73853095|NCT02907216|147254114|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-FHA antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||TWO_SIDED|95.0|-2.66|2.72|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-FHA antibody concentration ≥ 10 IU/mL.||2.72|-2.66|
73853096|NCT02907216|147254115|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 1 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||TWO_SIDED|95.0|-2.68|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 1 seroprotective titres ≥ 8 ED50.||2.74|-2.68|
73853097|NCT02907216|147254115|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 2 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||TWO_SIDED|95.0|-2.92|2.95|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 2 seroprotective titres ≥ 8 ED50.||2.95|-2.92|
73853098|NCT02907216|147254115|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 3 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.81|||||TWO_SIDED|95.0|-2.04|4.47|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 3 seroprotective titres ≥ 8 ED50.||4.47|-2.04|
73853099|NCT02241733|147254142|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||An independent t-test was completed.||||0.94
73853100|NCT02241733|147254143|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||||||0.078
73853101|NCT02241733|147254144|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
73853102|NCT02241733|147254145|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
73903005|NCT00591578|147336537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18||||0.003|TWO_SIDED|95.0|-3.63|-0.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.72|-3.63|0.003
73903006|NCT00591578|147336537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|||<|0.001|TWO_SIDED|95.0|-4.2|-1.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.25|-4.20|<0.001
73903007|NCT00591578|147336538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.38||||0.005|TWO_SIDED|95.0|-5.76|-1.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.00|-5.76|0.005
73903008|NCT00591578|147336538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.005|TWO_SIDED|95.0|-5.87|-1.06||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.06|-5.87|0.005
73903009|NCT00591578|147336539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.009|TWO_SIDED|95.0|-4.04|-0.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.59|-4.04|0.009
73903010|NCT00591578|147336539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.004|TWO_SIDED|95.0|-4.34|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.84|-4.34|0.004
73903011|NCT00591578|147336540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.016|TWO_SIDED|95.0|1.07|2.0||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.00|1.07|0.016
73903012|NCT00591578|147336540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.002|TWO_SIDED|95.0|1.19|2.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.23|1.19|0.002
73962237|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0517|TWO_SIDED|95.0|-0.37|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.00|-0.37|0.0517
73962238|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.61|-0.23|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-0.61|<0.0001
73962239|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.3621|TWO_SIDED|95.0|-0.37|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.13|-0.37|0.3621
73962240|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.0832|TWO_SIDED|95.0|-0.47|0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.47|0.0832
73962241|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4072|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4072
73962242|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.13||0.3404|TWO_SIDED|95.0|-0.39|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.13|-0.39|0.3404
73962243|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6344|TWO_SIDED|95.0|-0.34|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.34|0.6344
73853103|NCT00943098|147254187|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.71||||0.813|TWO_SIDED|95.0|-6.62|5.2|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.||5.20|-6.62|0.813
73853104|NCT00943098|147254200|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.51||||0.862|TWO_SIDED|95.0|-6.23|5.22|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.||5.22|-6.23|0.862
73853105|NCT04621240|147254203|SUPERIORITY|Mean level change from pre- to post-testing|Mean Difference (Net)|10.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73853106|NCT04621240|147254203|OTHER|Regression of the change in BrainHealth Index on age|Slope|0.03||||0.55|TWO_SIDED||||||Regression, Linear|||||||0.55
73853107|NCT03206918|147254204|SUPERIORITY||2-side Clopper-Pearson|87.9|||<|0.0001|TWO_SIDED|95.0|79.4|93.81|||Exact Binomial Test|The null hypothesis is ORR = 32%||||93.81|79.40|<0.0001
73853108|NCT03304054|147254210|OTHER|||||||0.2196||||||P-value for Wilcoxon-Mann-Whitney Test of Equality of change from baseline distributions between the amifampridine phosphate and placebo treatment groups.|Wilcoxon (Mann-Whitney)|||A Wilcoxon-Mann-Whitney Rank Sum Test of equality of change from baseline distributions between subjects diagnosed with MuSK-MG treated with amifampridine and placebo was conducted.||||0.2196
73853109|NCT03304054|147254211|OTHER|||||||0.3736||||||P-value for Wilcoxon-Mann-Whitney Test of Equality of change from baseline distributions between the amifampridine phosphate and placebo treatment groups.|Wilcoxon (Mann-Whitney)|||A Wilcoxon-Mann-Whitney Rank Sum Test of equality of change from baseline distributions between subjects diagnosed with MuSK-MG treated with amifampridine and placebo was conducted.||||0.3736
73853110|NCT04075292|147254249|SUPERIORITY||Hazard Ratio (HR)|0.08|||<|0.0001|TWO_SIDED|95.0|0.03|0.18|||Log Rank|The analysis was performed using the unstratified log-rank test.|HR was calculated using an unstratified Cox model with treatment as the only covariate. The CI for HR was calculated using the profile likelihood method.|||0.18|0.03|<0.0001
73853111|NCT03086408|147254399|OTHER||Mean Difference (Final Values)|-4.0||||0.09|TWO_SIDED|95.0|-9.0|1.0|||t-test, 2 sided|||||1.00|-9.00|0.09
73853112|NCT03086408|147254400|OTHER||Mean Difference (Final Values)|0.9||||0.61|TWO_SIDED|95.0|-2.89|4.69|||t-test, 2 sided|||||4.69|-2.89|0.61
73962244|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5756|TWO_SIDED|95.0|-0.35|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.35|0.5756
74024656|NCT01696461|147601708|OTHER||||||||||||||||||At 100 days after HCT, all patients in both the MAC and the RIC cohorts had achieved neutrophil engraftment. All patients in the MAC arm and 97% of patients in the RIC arm had achieved platelet engraftment. The median time to neutrophil engraftment was 13 and 15 days for MAC and RIC, respectively. The median time to platelet engraftment was 19 and 18 days for MAC and RIC, respectively.|||
73962245|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4394|TWO_SIDED|95.0|-0.38|0.16|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.38|0.4394
73853113|NCT03086408|147254401|OTHER||Mean Difference (Final Values)|-0.07||||0.78|TWO_SIDED|95.0|-0.61|0.47|||t-test, 2 sided|||||0.47|-0.61|0.78
73853114|NCT03086408|147254402|OTHER||Mean Difference (Final Values)|-0.4||||0.3|TWO_SIDED|95.0|-1.3|0.5|||t-test, 2 sided|||||0.50|-1.30|0.30
73853115|NCT03086408|147254403|OTHER||Mean Difference (Final Values)|0.1||||0.98|TWO_SIDED|95.0|-8.62|8.82|||t-test, 2 sided|||||8.82|-8.62|0.98
73853116|NCT03086408|147254404|OTHER||Mean Difference (Final Values)|0.6||||0.61|TWO_SIDED|95.0|-1.64|2.84|||t-test, 2 sided|||||2.84|-1.64|0.61
73853117|NCT03086408|147254405|OTHER||Mean Difference (Final Values)|13.7||||0.04|TWO_SIDED|95.0|0.63|26.77|||t-test, 2 sided|||||26.77|0.63|0.04
73853118|NCT03086408|147254406|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-2.8|2.8|||t-test, 2 sided|||||2.80|-2.80|1
73853119|NCT03086408|147254407|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-2.38|1.98|||t-test, 2 sided|||||1.98|-2.38|0.82
73853120|NCT03086408|147254408|OTHER||Mean Difference (Final Values)|-1.5||||0.37|TWO_SIDED|95.0|-5.29|2.29|||t-test, 2 sided|||||2.29|-5.29|0.37
73853121|NCT03367403|147254409|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.56||0.042|TWO_SIDED|95.0|0.12|6.27|||Mixed Models Analysis|||||6.27|0.12|0.042
73853122|NCT03367403|147254410|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|0.898||0.04|TWO_SIDED|95.0|-3.63|-0.09|||Mixed Models Analysis|||||-0.09|-3.63|0.040
73853123|NCT03367403|147254411|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.239||0.139|TWO_SIDED|95.0|-0.83|0.12|||Mixed Models Analysis|||||0.12|-0.83|0.139
73853124|NCT03367403|147254412|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.525||0.227|TWO_SIDED|95.0|-0.4|1.67|||Mixed Models Analysis|||||1.67|-0.40|0.227
73853125|NCT03367403|147254413|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|1.009||0.23|TWO_SIDED|95.0|-0.77|3.2|||Mixed Models Analysis|||||3.20|-0.77|0.230
73853126|NCT03367403|147254414|SUPERIORITY||Mean Difference (Final Values)|-85.06|STANDARD_ERROR_OF_MEAN|3.867|<|0.001|TWO_SIDED|95.0|-92.68|-77.43|||Mixed Models Analysis|||||-77.43|-92.68|<0.001
73853127|NCT03367403|147254415|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.56|TWO_SIDED|95.0|-0.01|0.03|||ANCOVA|||Tau-IQ||0.03|-0.01|0.560
73853128|NCT03367403|147254415|SUPERIORITY||Mean Difference (Final Values)|0.035||||0.012|TWO_SIDED|95.0|0.007|0.062|||ANCOVA|||MUBADA-Cerebellum||0.062|0.007|0.012
73853129|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|-2.67|STANDARD_ERROR_OF_MEAN|0.631|<|0.001|TWO_SIDED|95.0|-3.92|-1.43|||Mixed Models Analysis|||Bilateral Cortical||-1.43|-3.92|< 0.001
73962246|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7747|TWO_SIDED|95.0|-0.31|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.31|0.7747
74024657|NCT01696461|147601709|OTHER||||||||||||||||||"Full donor myeloid chimerism was achieved relatively quickly in both RIC and MAC groups (median 100% at day +28 in both RIC and MAC), but conversion to full donor T-cell chimerism appeared to be slower in the RIC patients.~T-cell chimerism for MAC patients: median donor cell % (range):~Day +28: 92(59-100)%, Day +100: 97(76-100)%, Day +180: 100(91-100)%, Day +365: 100(100-100)%~T-cell chimerism for RIC patients: median donor cell % (range):~Day +28: 80(50-100)%, Day +100: 84(64-100)%, Day +180: 95(74-100)%, Day +365: 100(87-100)%"|||
74024658|NCT01696461|147601710|OTHER||||||||||||||||||This is a descriptive outcome.There were no cases of primary graft failure.|||
73853130|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.011||0.916|TWO_SIDED|95.0|-0.02|0.02|||Mixed Models Analysis|||Bilateral Entorhinal Cortex||0.02|-0.02|0.916
73853131|NCT03367403|147254416|SUPERIORITY|Bilateral Hippocampus|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.019||0.771|TWO_SIDED|95.0|-0.03|0.04|||Mixed Models Analysis|||||0.04|-0.03|0.771
73853132|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.047||0.094|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|||Bilateral Inferior Parietal Lobe||0.01|-0.17|0.094
73853133|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.052|TWO_SIDED|95.0|-0.04|0.0|||Mixed Models Analysis|||Bilateral Isthmuscingulate||0.00|-0.04|0.052
73853134|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.118||0.005|TWO_SIDED|95.0|-0.57|-0.11|||Mixed Models Analysis|||Bilateral Lateral Parietal Lobe||-0.11|-0.57|0.005
73853135|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.036||0.731|TWO_SIDED|95.0|-0.08|0.06|||Mixed Models Analysis|||Bilateral Medial Temporal Lobe||0.06|-0.08|0.731
73853136|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.046|<|0.001|TWO_SIDED|95.0|-0.25|-0.07|||Mixed Models Analysis|||Bilateral Precuneus||-0.07|-0.25|<0.001
73853137|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.114|<|0.001|TWO_SIDED|95.0|-0.62|-0.17|||Mixed Models Analysis|||Bilateral Prefrontal Lobe||-0.17|-0.62|<0.001
73853138|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|-0.3|-0.12|||Mixed Models Analysis|||Bilateral Superior Temporal Lobe||-0.12|-0.30|<0.001
73853139|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|2.28|STANDARD_ERROR_OF_MEAN|0.581|<|0.001|TWO_SIDED|95.0|1.14|3.43|||Mixed Models Analysis|||Bilateral Ventricles||3.43|1.14|< 0.001
73853140|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|-4.58|STANDARD_ERROR_OF_MEAN|1.519||0.003|TWO_SIDED|95.0|-7.58|-1.59|||Mixed Models Analysis|||Bilateral Whole Brain||-1.59|-7.58|0.003
73853141|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.03|-0.33|||Mixed Models Analysis|||Bilateral Whole Temporal Lobe||-0.33|-1.03|<0.001
73853142|NCT03367403|147254416|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|0.987||0.022|TWO_SIDED|95.0|-4.23|-0.33|||Mixed Models Analysis|||Bilateral White Matter||-0.33|-4.23|0.022
73853143|NCT03470194|147254425|OTHER||||||=|0.002|||||||Wilcoxon (Mann-Whitney)|||||||=0.002
73853144|NCT01822899|147254446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|95.0|0.046|0.113|||ANCOVA|||||0.113|0.046|<0.001
73853145|NCT03636893|147254481|OTHER|Two-sided log-rank test comparing disease-free survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \<0.05.|Hazard Ratio (HR)|1.06||||0.842|TWO_SIDED|95.0|0.597|1.884||P-value from two-sided log-rank test. Alpha level set at 0.05.|Log Rank|Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.|Hazard ratio from Cox proportional hazards regression with FLOT as reference group.|Disease-free survival analysis in intention-to-treat population. DFS defined as time from randomization to first occurrence of local recurrence, regional recurrence, distant metastases, or death from any cause.|Kaplan-Meier method used to estimate DFS curves. Cox regression performed to calculate hazard ratios.|1.884|0.597|0.842
73853146|NCT03636893|147254482|OTHER|Two-sided log-rank test comparing overall survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \<0.05.|Hazard Ratio (HR)|1.101||||0.759|TWO_SIDED|95.0|0.595|2.036||P-value from two-sided log-rank test. No adjustment for multiple comparisons as overall survival was a pre-specified secondary endpoint. Alpha level set at 0.05.|Log Rank|Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.|Hazard ratio from Cox proportional hazards regression with FLOT as reference group.|Primary survival analysis comparing overall survival between neoadjuvant FLOT and SOX regimens in intention-to-treat population.|Kaplan-Meier method used to estimate survival curves. Cox regression performed to calculate hazard ratios. Multivariable analysis performed to identify independent predictors.|2.036|0.595|0.759
73853147|NCT00758069|147254483|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-25.9|||<|0.001||95.0|-34.2|-17.5||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-17.5|-34.2|<0.001
73853148|NCT00758069|147254483|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-19.5|||<|0.001||95.0|-28.0|-11.1||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-11.1|-28.0|<0.001
73853149|NCT00758069|147254484|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-19.3|||<|0.001||95.0|-26.6|-11.9||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-11.9|-26.6|<0.001
73853150|NCT00758069|147254484|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-12.9|||<|0.001||95.0|-20.4|-5.4||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-5.4|-20.4|<0.001
73853151|NCT03818607|147254496|NON_INFERIORITY|The clinical similarity of the Week 27 LDH between treatments was assessed by comparing the 1-sided 97.5% upper confidence interval (CI) limit for the geometric mean ratio of LDH at Week 27 between ABP 959 treatment and eculizumab treatment with a non-inferiority margin of 2.873.|Geometric LS mean ratio (GMR)|1.0628|||||ONE_SIDED|97.5||1.1576||||||||1.1576||
73853152|NCT03818607|147254497|OTHER|The clinical similarity of the AUEC between treatments was assessed by comparing 2-sided 90% CI for the GMR of the time-adjusted AUEC of LDH (Week 13 to Week 27, Week 39 to Week 53, and Week 65 to Week 79) between ABP 959 treatment and eculizumab treatment with a similarity margin of (0.77, 1.30).|GMR|0.9812|||||TWO_SIDED|90.0|0.9403|1.0239||||||||1.0239|0.9403|
73853153|NCT03818607|147254505|OTHER||GMR|1.0314|||||ONE_SIDED|97.5||1.1201||||||||1.1201||
73853154|NCT03818607|147254508|OTHER||GMR|0.9122|||||TWO_SIDED|90.0|0.7586|1.0968||||||Total PK AUC GMR (ABP 959/Eculizumab)||1.0968|0.7586|
73853155|NCT03818607|147254508|OTHER||GMR|0.9508|||||TWO_SIDED|90.0|0.7454|1.213||||||Unbound PK AUC GMR (ABP 959/Eculizumab)||1.2130|0.7454|
73971041|NCT05651308|147482272|SUPERIORITY||Risk Difference (RD)|0.026||||0.37|TWO_SIDED|95.0|-0.03|0.08|||Chi-squared||Risk difference = Intervention proportion minus control proportion.|||0.08|-0.03|0.37
73971042|NCT02969707|147482281|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|2-sample t-test||Examining the Change in sum of positive z-transformed CC.||||0.035
73971043|NCT02969707|147482281|SUPERIORITY|||||||0.7||||||2-sample t-test|t-test, 2 sided|||Examining the change in sum of all z-transformed CC.||||0.7
73971044|NCT02969707|147482281|SUPERIORITY|2-sample t-test||||||0.11|||||||t-test, 2 sided|||Examining the change in sum of negative z-transformed CC.||||0.11
73903013|NCT00591578|147336541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.041|TWO_SIDED|95.0|1.02|2.1||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.10|1.02|0.041
73903014|NCT00591578|147336541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.015|TWO_SIDED|95.0|1.09|2.28||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.28|1.09|0.015
73903015|NCT00591578|147336542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.018|TWO_SIDED|95.0|1.07|1.99||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||1.99|1.07|0.018
73903016|NCT00591578|147336542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.24|2.33||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.33|1.24|<0.001
73903017|NCT04533685|147336558|SUPERIORITY||Adjusted Risk Ratio|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Adjusted risk ratio. These results compare arms which received reminder letters to the arm receiving no reminder letter (control)|Comparing the risk of receiving an influenza vaccination||1.02|1.00|
73903018|NCT04533685|147336558|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||||These results compare arms which received direct appointment scheduling to the arms not receiving direct appointment scheduling.|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
73903019|NCT04533685|147336558|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|1.0|1.01|||||These results compare arms which received pre-commitment reminders to the arms not receiving pre-commitment reminders.|Comparing the risk of receiving an influenza vaccination||1.01|1.00|
73903020|NCT04533685|147336558|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||These results compare arms which received pre-appointment reminder to the arms not receiving pre-appointment reminder.|Comparing the risk of receiving an influenza vaccination||1.01|0.99|
73962247|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7305|TWO_SIDED|95.0|-0.32|0.22|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.32|0.7305
74024659|NCT01696461|147601711|OTHER|||||||||||||||||The cumulative incidence of acute graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.|The incidence of acute GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing risk.|||
74024660|NCT01696461|147601712|OTHER||||||||||||||||||Immune reconstitution was measured by CD3+CD4+ and CD3+CD8+ T cells in the peripheral blood of patients at days 28, 100, 180, and 365 after HCT. Notably, median CD3+CD4+ cell counts were \>200/µL at all times analyzed, including day 28 in both MAC and RIC groups.|||
73903021|NCT04221230|147336559|OTHER||Least square mean difference|-1.7|STANDARD_ERROR_OF_MEAN|1.08||0.121|TWO_SIDED|95.0|-3.8|0.4|||Mixed Model Repeated Measures|||||0.4|-3.8|0.121
73903022|NCT02021656|147336578|SUPERIORITY||||||<|0.001|||||||Binomial Exact Test|||A sample size of 100 Chinese participants in the treatment naive group provided at least 90% power to detect a 17% improvement in SVR12 rate from the historical control rate of 57% using 2-sided exact one-sample binomial test at significant level of 0.05.||||<0.001
73903023|NCT02043379|147336585|NON_INFERIORITY_OR_EQUIVALENCE|We used alpha level of 0.05 and power of 0.8 to calculate the sample size necessary to detect a meaningful clinical difference for our primary endpoint.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
73903024|NCT02043379|147336586|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
73903025|NCT02043379|147336587|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||0.38
73903026|NCT02043379|147336588|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.26||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||0.26
73903027|NCT02043379|147336589|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42|TWO_SIDED|95.0||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||24 hour post-CPB albumin||||0.42
73903028|NCT02043379|147336589|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||a p-value of \<0.05 represents the threshold for test signficance|t-test, 2 sided|||48 hour post CPB albumin||||0.06
73962248|NCT02528188|147460949|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.733|TWO_SIDED|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.32|-0.22|0.7330
74024661|NCT01696461|147601713|OTHER|||||||||||||||||Groups were not directly compared using a statistical test.|Percentage of recipients at-risk for CMV reactivation who experienced a reactivation.|||
73903029|NCT02043379|147336590|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.52
73903030|NCT02043379|147336591|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.81||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||Admit Inotrope Score||||0.81
73903031|NCT02043379|147336591|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.82||||||a p value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative inotrope score||||0.82
73903032|NCT02043379|147336591|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.9||||||a p value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative inotrope score||||0.9
73903033|NCT02043379|147336591|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.23||||||a p-value of \<0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||48 hours post-operative inotrope score||||0.23
73903034|NCT02043379|147336592|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.49||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.49
73962249|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2159|TWO_SIDED|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.10|0.2159
73962250|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2049|TWO_SIDED|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.10|0.2049
73903035|NCT02043379|147336593|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.79
73903036|NCT02043379|147336594|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.32||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative IgG level||||0.32
73903037|NCT02043379|147336594|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.36||||||a p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative IgG level||||0.36
73903038|NCT02043379|147336594|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of \<0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||post-operative day 3 (72 hours) IgG level||||<0.01
73903039|NCT02043379|147336594|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||post-operative day 5 (120 hours) IgG level||||<0.01
73903040|NCT02043379|147336595|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.6||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.60
73903041|NCT02043379|147336595|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.06
73962251|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.03||0.0002|TWO_SIDED|95.0|-0.19|-0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.19|0.0002
73971045|NCT02969707|147482281|SUPERIORITY||Mean Difference (Net)|61.98||||0.008|TWO_SIDED||||||t-test, 2 sided|One sample(paired) t-test||Examining the change in positive functional connectivity between the L-DLPFC and the dACC within the active group from pre to post TMS.||||0.008
73971046|NCT02969707|147482283|OTHER||Mann-Whitney U statistic|601.0||||0.046|TWO_SIDED||||||Mann-Whitney U-test 2-tailed|||Non-parametric analysis, comparison of change (post-treatment minus pre-treatment)||||0.046
73971047|NCT02969707|147482283|OTHER||Cohen's R|0.25|||||TWO_SIDED||||||||Estimate of effect size|Non-parametric analysis, comparison of change (post-treatment minus pre-treatment)||||
73903042|NCT02043379|147336595|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.06
73971048|NCT02969707|147482284|SUPERIORITY|We assessed the superiority of active over sham.|Mann-Whitney U statistic|702.5|||=|0.412|TWO_SIDED||||||Mann-Whitney U-test 2-tailed|||Pre- to post-rTMS change in HIS scores were calculated for both Active and Sham conditions. Two-tailed t-tests were used to evaluate the difference between the two conditions' change scores.||||=.412
73971049|NCT02969707|147482287|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|2-sample t-test||||||0.037
73971050|NCT02969707|147482287|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||0.063
73971051|NCT02969707|147482287|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
73971052|NCT02969707|147482292|SUPERIORITY|We assessed the superiority of active over sham.|Cohen's d|-0.234||||0.49|TWO_SIDED||||||Mixed-effects model|||We used standard mixed-effects modeling to estimate the change (slope) in pain in our 2\*2 pre- and post-assessment design. Pain ratings were calculated by averaging pain ratings across 5 assessments under four conditions (TMS with hypnosis, TMS without hypnosis, Sham with hypnosis, Sham without hypnosis). Based on these change estimates, we derived the two main effects (TMS, Hypnosis) and their interaction effect on the change in pain from the pre- to post-treatment assessment.||||0.49
74024662|NCT01696461|147601714|OTHER|||||||||||||||||The probability of treatment-related mortality and disease relapse/progression were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.|The incidence of treatment-related mortality and relapse was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. When computing the cumulative incidence probability of treatment-related mortality and relapse, relapse and treatment-related mortality, respectively, were considered as a competing risk.|||
73903043|NCT02043379|147336595|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.33||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative||||0.33
73903044|NCT02043379|147336595|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.05||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative||||0.05
73903045|NCT02043379|147336595|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.83||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hours post-operative||||0.83
73903046|NCT02043379|147336596|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour levels||||0.27
73903047|NCT02043379|147336596|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level||||0.34
73903048|NCT02043379|147336596|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level||||0.14
73903049|NCT02043379|147336596|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.13||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level||||0.13
73903050|NCT02043379|147336596|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level||||0.02
73903051|NCT02043379|147336597|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
74024663|NCT01696461|147601715|OTHER|||||||||||||||||The probability of progression free survival and overall survival were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.|Kaplan-Meier curves were used to estimate the probability of progression-free survival and overall survival. Progression-free survival at 1 year was 53% (95% CI, 36% to 71%) after MAC and 64% (95% CI, 47% to 79%) after RIC. Overall survival at 1 year was 63% (95% CI, 46% to 79%) after MAC and 70% (95% CI, 53% to 84%) after RIC.|||
74088275|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-9.41|STANDARD_ERROR_OF_MEAN|3.74||0.0135|TWO_SIDED|95.0|-16.83|-1.99|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-1.99|-16.83|0.0135
73903052|NCT02043379|147336598|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.4||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.4
73903053|NCT02043379|147336599|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.09||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-48 hours post-CPB||||0.09
73903054|NCT02043379|147336599|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-24 hours post CPB||||0.52
73903055|NCT02043379|147336600|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.72||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.72
73903056|NCT02043379|147336601|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.63||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.63
73903057|NCT02043379|147336602|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.41||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.41
73903058|NCT02043379|147336602|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.34
73903059|NCT02043379|147336602|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.47
73903060|NCT02043379|147336602|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.42
73903061|NCT02043379|147336602|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.82
73903062|NCT02043379|147336602|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.44||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.44
73903063|NCT02043379|147336603|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.28||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.28
74024664|NCT01696461|147601716|OTHER|||||||||||||||||This outcome measure is descriptive.|This outcome measure is descriptive. The median cell dose and range are reported.|||
73853156|NCT05059301|147254513|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% confidence interval (CI) of the GMC ratios (RSV OA\_Lot 1 divided by RSV OA\_Lot 2) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|1.06|||||TWO_SIDED|95.0|0.94|1.21||||||To demonstrate the clinical equivalence of RSV OA\_Lot 1 versus RSV OA\_Lot 2 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||1.21|0.94|
73853157|NCT05059301|147254513|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% CI of the GMC ratios (RSV OA\_Lot 1 divided by RSV OA\_Lot 3) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|0.92|||||TWO_SIDED|95.0|0.81|1.04||||||To demonstrate the clinical equivalence of RSV OA\_Lot 1 versus RSV OA\_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||1.04|0.81|
73853158|NCT05059301|147254513|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% CI of the GMC ratios (RSV OA\_Lot 2 divided by RSV OA\_Lot 3) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|0.87|||||TWO_SIDED|95.0|0.77|0.99||||||To demonstrate the clinical equivalence of RSV OA\_Lot 2 versus RSV OA\_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||0.99|0.77|
73853159|NCT01988662|147254593|NON_INFERIORITY_OR_EQUIVALENCE|"H0: There is no difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept.~HA: There is a difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept."|Mean Difference (Net)|62.57|STANDARD_ERROR_OF_MEAN|24.639||0.012|TWO_SIDED|95.0|13.96|111.17|||Mixed Models Analysis|||H0: μR = μA versus HA: μR ≠ μA||111.17|13.96|0.012
73853160|NCT00842153|147254600|SUPERIORITY_OR_OTHER|||||||0.1269||95.0||||P-value for Week 1|Fisher Exact|||||||0.1269
73853161|NCT00842153|147254600|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 2|Chi-squared|||||||<0.0001
73853162|NCT00842153|147254600|SUPERIORITY_OR_OTHER|||||||0.0015||95.0||||P-value for Week 4|Chi-squared|||||||0.0015
73853163|NCT00002540|147254617|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36||Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.|Poisson regression|||||1.36|0.87|
73853164|NCT00002540|147254619|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.93|1.0|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.00|0.93|
73853165|NCT00002540|147254621|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|1.07|1.17|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.17|1.07|
73853166|NCT00002540|147254631|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36|||Poisson regression|||||1.36|0.87|
73853167|NCT04445519|147254637|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the 95.1% CIs around the difference (NCX 470 minus latanoprost 0.005%) in mean IOP reduction from time-matched baseline in the study eye was greater than or equal to -1.5 mmHg at all time points and was greater than or equal to -1.0 mmHg at a majority of the time points.|Mean Difference (Net)|1.0|STANDARD_DEVIATION|3.25|||TWO_SIDED|95.1||||The primary efficacy assessment was the non-inferiority analysis of the difference in the treatment effect between NCX 470 and latanoprost 0.005% for mean IOP reduction from time-matched baseline at the 8AM and 4PM time-points.|||The analysis assumed a true difference of 1.0 mmHg at the Week 2 time points and 1.25 mmHg at the Week 6 and Month 3 time points; a common standard deviation (SD) at each time-point of 3.25 mmHg; and a two-sided significance level of 4.9%.|||||
73853168|NCT01345929|147254641|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.5|||||TWO_SIDED|95.0|2.31|14.57||||||||14.57|2.31|
73853169|NCT01345929|147254642|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.0|||||TWO_SIDED|95.0|1.95|13.97||||||||13.97|1.95|
73853170|NCT00177294|147254686|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Regression, Logistic|||We conducted Cox regreassion analyses of time to remission and logistic modeling for rates of remission. We tested group difference in Hamilton depession ratings over time via mixed-effects modeling.||||0.14
73903064|NCT02043379|147336603|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.37||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.37
73903065|NCT02043379|147336603|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.42
73903066|NCT02043379|147336603|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.31||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.31
73903067|NCT02043379|147336603|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.38
73903068|NCT02043379|147336603|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.4||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.4
73903069|NCT02043379|147336604|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.1
73903070|NCT02043379|147336604|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.12||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.12
73903071|NCT02043379|147336604|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.51||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.51
73903072|NCT02043379|147336604|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.27
73903073|NCT02043379|147336604|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.88||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.88
73903074|NCT02043379|147336604|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.38
73903075|NCT02043379|147336605|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.35||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.35
73903076|NCT02043379|147336605|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.39||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.39
73903077|NCT02043379|147336605|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.58||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.58
73962252|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.21|-0.08|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.21|<0.0001
73962253|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7799|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.08|0.7799
74088276|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-10.04|STANDARD_ERROR_OF_MEAN|3.97||0.0129|TWO_SIDED|95.0|-17.91|-2.17|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.17|-17.91|0.0129
73903078|NCT02043379|147336605|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.36||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.36
73903079|NCT02043379|147336605|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.61||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.61
73903080|NCT02043379|147336605|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.38
73903081|NCT02043379|147336606|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.1
73903082|NCT02043379|147336606|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.02
73903083|NCT02043379|147336606|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.34
73903084|NCT02043379|147336606|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.35||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.35
73903085|NCT02043379|147336606|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.67||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.67
73903086|NCT02043379|147336606|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.47
73903087|NCT02043379|147336607|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.46||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.46
73903088|NCT02043379|147336607|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.04
73962254|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0061|TWO_SIDED|95.0|-0.16|-0.03|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.03|-0.16|0.0061
73903089|NCT02043379|147336607|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.14
73903090|NCT02043379|147336607|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.82
73903091|NCT02043379|147336607|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.9||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.9
73903092|NCT02043379|147336607|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.78||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.78
73903093|NCT02043379|147336608|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.37||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour level||||0.37
73903094|NCT02043379|147336608|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level||||0.47
73962255|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9718|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9718
73962256|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3292|TWO_SIDED|95.0|-0.14|0.05|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.05|-0.14|0.3292
73962257|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.983|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9830
73962258|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.9137|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.09|0.9137
73962259|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8784|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.09|-0.11|0.8784
73962260|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9995|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9995
73903095|NCT02043379|147336608|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level||||0.47
73903096|NCT02043379|147336608|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level||||0.79
73903097|NCT02043379|147336608|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level||||0.04
73903098|NCT02043379|147336609|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.43||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative||||0.43
73903099|NCT02043379|147336609|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.68||||||A p-value of \<0.05 represents the threshold for statistical significance|t-test, 2 sided|||max||||0.68
73903100|NCT02043379|147336610|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.87||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative||||0.87
73903101|NCT02043379|147336610|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance|t-test, 2 sided|||24 hour post-operative max||||0.79
73903102|NCT00282347|147336611|SUPERIORITY_OR_OTHER|||||||0.5538|TWO_SIDED||||||Stratified Wilcoxon-Rank Sum Test|||||||0.5538
73903103|NCT00491556|147336625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.08|STANDARD_DEVIATION|5.13|<|0.0001|TWO_SIDED|95.0|-12.2|-7.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||-7.97|-12.20|<0.0001
73962261|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.6648|TWO_SIDED|95.0|-0.13|0.08|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.13|0.6648
73903104|NCT00491556|147336626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_DEVIATION|5.0||0.0834|TWO_SIDED|95.0|-3.87|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||0.26|-3.87|0.0834
73903105|NCT00491556|147336627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-317.36|STANDARD_DEVIATION|176.07|<|0.0001|TWO_SIDED|95.0|-390.04|-244.68|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||-244.68|-390.04|<0.0001
73903106|NCT00491556|147336628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2|STANDARD_DEVIATION|242.38||0.6222|TWO_SIDED|95.0|-124.25|75.85|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||75.85|-124.25|0.6222
73903107|NCT00491556|147336629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.79|STANDARD_DEVIATION|152.57||0.0781|TWO_SIDED|95.0|-124.77|7.18|||t-test, 2 sided|||Null hypothesis is no changes between Baseline and Week 48.||7.18|-124.77|0.0781
73903108|NCT00491556|147336630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-103.53|STANDARD_DEVIATION|176.61||0.0102|TWO_SIDED|95.0|-179.9|-27.16|||t-test, 2 sided|||Null hypothesis is no changes between Week 48 and Week 152||-27.16|-179.90|0.0102
73903109|NCT00491556|147336631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.13|STANDARD_DEVIATION|56.72||0.1616|TWO_SIDED|95.0|-41.66|7.4|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||7.40|-41.66|0.1616
73903110|NCT00491556|147336632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.08|STANDARD_DEVIATION|75.17||0.0117|TWO_SIDED|95.0|-75.59|-10.58|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||-10.58|-75.59|0.0117
73903111|NCT00491556|147336633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-76.92|STANDARD_DEVIATION|56.31|<|0.0001|TWO_SIDED|95.0|-101.27|-52.57|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Week 48 and Week 152||-52.57|-101.27|< 0.0001
73903112|NCT00491556|147336634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.87|STANDARD_DEVIATION|68.75||0.2519|TWO_SIDED|95.0|-12.86|46.6|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||46.60|-12.86|0.2519
73962262|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.728|TWO_SIDED|95.0|-0.09|0.12|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.09|0.7280
73962263|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8856|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.09|0.8856
73903113|NCT00491556|147336635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-126.79|STANDARD_DEVIATION|105.61|<|0.0001|TWO_SIDED|95.0|-172.46|-81.12|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-81.12|-172.46|< 0.0001
73903114|NCT00491556|147336636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.64|STANDARD_DEVIATION|97.71||0.0003|TWO_SIDED|95.0|45.39|129.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||129.90|45.39|0.0003
73903115|NCT00491556|147336637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.46|STANDARD_DEVIATION|213.77||0.3739|TWO_SIDED|95.0|-51.98|132.9|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||132.90|-51.98|0.3739
73903116|NCT00491556|147336638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-91.86|STANDARD_DEVIATION|166.4||0.0147|TWO_SIDED|95.0|-163.82|-19.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-19.90|-163.82|0.0147
73903117|NCT00491556|147336639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.81|STANDARD_DEVIATION|76.07|<|0.0001|TWO_SIDED|95.0|46.92|112.71|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||112.71|46.92|< 0.0001
73903118|NCT00491556|147336640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|STANDARD_DEVIATION|58.18||0.1067|TWO_SIDED|95.0|-45.56|4.76|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||4.76|-45.56|0.1067
73903119|NCT00491556|147336641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.82|STANDARD_DEVIATION|107.8||0.0005|TWO_SIDED|95.0|44.2|137.43|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||137.43|44.20|0.0005
73903120|NCT00491556|147336642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.49|STANDARD_DEVIATION|64.41||0.0207|TWO_SIDED|95.0|5.64|61.34|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||61.34|5.64|0.0207
73903121|NCT00491556|147336643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.37|STANDARD_DEVIATION|145.62||0.2082|TWO_SIDED|95.0|-102.34|23.6|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Week 48 and Week 152.||23.60|-102.34|0.2082
73903122|NCT00491556|147336644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.98|STANDARD_DEVIATION|139.33||0.0067|TWO_SIDED|95.0|26.73|147.23|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||147.23|26.73|0.0067
73853171|NCT02443116|147254687|SUPERIORITY||Difference in least squares means|-8.84|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|96.0|-12.09|-5.59||p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.|t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-5.59|-12.09|<0.001
73962264|NCT02528188|147460951|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.05||0.2814|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.05|0.2814
73853172|NCT02443116|147254687|SUPERIORITY||Difference in least squares means|-11.06|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|96.0|-14.39|-7.74||p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.|t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-7.74|-14.39|<0.001
73853173|NCT02443116|147254687|SUPERIORITY||Difference in least squares means|-2.22|STANDARD_ERROR_OF_MEAN|1.38||0.112|TWO_SIDED|96.0|-5.11|0.67|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||0.67|-5.11|0.112
73853174|NCT02443116|147254688|SUPERIORITY||Difference in least squares means|-5.73|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-8.48|-2.99|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-2.99|-8.48|<0.0001
73853175|NCT02443116|147254688|SUPERIORITY||Difference in least squares means|-6.6|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-9.41|-3.79|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-3.79|-9.41|<0.0001
73853176|NCT02443116|147254688|SUPERIORITY||Difference in least squares means|-0.87|STANDARD_ERROR_OF_MEAN|1.43||0.5467|TWO_SIDED|95.0|-3.71|1.98|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||1.98|-3.71|0.5467
73853177|NCT02443116|147254688|SUPERIORITY||Difference in least squares means|-5.9|STANDARD_ERROR_OF_MEAN|1.33|<|0.0001|TWO_SIDED|95.0|-8.55|-3.25|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-3.25|-8.55|<0.0001
73853178|NCT02443116|147254688|SUPERIORITY||Difference in least squares means|-0.17|STANDARD_ERROR_OF_MEAN|1.37||0.9037|TWO_SIDED|95.0|-2.89|2.55|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||2.55|-2.89|0.9037
73853179|NCT02443116|147254688|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|1.38||0.6134|TWO_SIDED|95.0|-2.05|3.45|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||3.45|-2.05|0.6134
73853180|NCT02443116|147254689|SUPERIORITY||Difference in least squares means|-4.97|STANDARD_ERROR_OF_MEAN|1.53||0.0018|TWO_SIDED|95.0|-8.03|-1.91|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-1.91|-8.03|0.0018
73853181|NCT02285023|147254695|NON_INFERIORITY_OR_EQUIVALENCE|Principal component analysis with varimax rotation was employed. An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5.|||||<|0.01||||||An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5|exploratory factor analysis|An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5||Exploratory factor analysis||||<0.01
73853182|NCT02285023|147254696|SUPERIORITY_OR_OTHER||Cronbach's alpha|0.94|||<|0.05|TWO_SIDED||||||Crohbach's alpha|||||||<0.05
73853183|NCT01751906|147254813|SUPERIORITY|||||||0.9256|||||||Chi-squared|||||||0.9256
73853184|NCT01751906|147254814|SUPERIORITY|||||||0.504|||||||Fisher Exact|||||||0.5040
73853185|NCT01751906|147254815|SUPERIORITY|||||||0.2126|||||||Fisher Exact|||||||0.2126
73853186|NCT01751906|147254842|SUPERIORITY|||||||0.0665|||||||Chi-squared|||||||0.0665
73853187|NCT01460875|147254873|NON_INFERIORITY|The method to be developed will allow us to declare that a response at a lower dose is not inferior to that at the standard dose for a particular patient, using a patient specific inferiority test.||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||.22
73853188|NCT04644276|147254883|SUPERIORITY||Median Difference (Final Values)|-37.0|STANDARD_DEVIATION|102.0||0.8125|TWO_SIDED|95.0|-112.6|140.7|||Wilcoxon Signed-Ranks test||Unit is percent change.|Percent change in leak 100% x (\[Mask with mask adhesive\] - \[Mask without mask adhesive\])/ \[Mask without mask adhesive\]. The comparison between the two arms is captured in the reported percentage change.||140.7|-112.6|0.8125
73962265|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4691|TWO_SIDED|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2||1.28|0.89|0.4691
73962266|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|0.95||||0.5451|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2||1.13|0.79|0.5451
74024665|NCT01696461|147601717|OTHER|||||||||||||||||The cumulative incidence of chronic graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.|The incidence of chronic GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing event.|||
74024666|NCT01696461|147601718|OTHER||||||||||||||||||This is a descriptive analysis. There were no cases of secondary graft failure.|||
74024667|NCT01696461|147601719|OTHER||||||||||||||||||This outcome measure is descriptive. The median cell dose and range are reported.|||
73903123|NCT00491556|147336645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.07|STANDARD_DEVIATION|13.2|<|0.0001|TWO_SIDED|95.0|-23.78|-12.36|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-12.36|-23.78|< 0.0001
73903124|NCT00491556|147336646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_DEVIATION|14.2||0.5815|TWO_SIDED|95.0|-4.48|7.8|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||7.80|-4.48|0.5815
73903125|NCT00491556|147336647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.24|STANDARD_DEVIATION|7.82|<|0.0001|TWO_SIDED|95.0|7.85|14.62|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||14.62|7.85|< 0.0001
73903126|NCT00491556|147336648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87|STANDARD_DEVIATION|6.93||0.0594|TWO_SIDED|95.0|-5.87|0.12|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.12|-5.87|0.0594
73903127|NCT00491556|147336649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.58|STANDARD_DEVIATION|10.24||0.0001|TWO_SIDED|95.0|8.15|17.01|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.01|8.15|0.0001
73903128|NCT00491556|147336650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93|STANDARD_DEVIATION|10.95||0.0995|TWO_SIDED|95.0|-0.81|8.66|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||8.66|-0.81|0.0995
73962267|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0059|TWO_SIDED|95.0|1.08|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4||1.54|1.08|0.0059
74024668|NCT01245647|147601762|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
73962268|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0057|TWO_SIDED|95.0|1.08|1.55|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4||1.55|1.08|0.0057
74024669|NCT01245647|147601763|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
74024670|NCT01245647|147601764|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.46
74024671|NCT01245647|147601765|SUPERIORITY_OR_OTHER|||||||0.12||||||no significant difference by Fisher exact test|Fisher Exact|||||||0.12
74024672|NCT01245647|147601766|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.67
73903129|NCT00491556|147336651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_DEVIATION|2.07||0.0002|TWO_SIDED|95.0|1.05|2.84|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||2.84|1.05|0.0002
73903130|NCT00491556|147336652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|1.49||0.915|TWO_SIDED|95.0|-0.61|0.68|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.68|-0.61|0.9150
73903131|NCT00491556|147336653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.52|STANDARD_DEVIATION|13.79|<|0.0001|TWO_SIDED|95.0|-29.48|-17.55|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-17.55|-29.48|< 0.0001
73903132|NCT00491556|147336654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_DEVIATION|16.96||0.5864|TWO_SIDED|95.0|-5.38|9.28|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||9.28|-5.38|0.5864
73903133|NCT00491556|147336655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.98|STANDARD_DEVIATION|8.48|<|0.0001|TWO_SIDED|95.0|18.31|25.65|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||25.65|18.31|< 0.0001
73903134|NCT00491556|147336656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|7.25||0.1592|TWO_SIDED|95.0|-5.34|0.93|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.93|-5.34|0.1592
73903135|NCT00491556|147336657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.97|STANDARD_DEVIATION|11.04||0.042|TWO_SIDED|95.0|0.2|9.74|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||9.74|0.20|0.0420
74024673|NCT01392183|147601785|SUPERIORITY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.84|2.22|||||Adjusted Hazard Ratio comparing Median PFS of pazopanib (treatment group) to Temsirolimus (control group) as first line of treatment. HR \>1 treatment group performed better, \< 1 the control group performed better =1 groups performed equally.|||2.22|0.84|
74024674|NCT01392183|147601786|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.7|1.93|||||Adjusted HR comparing Median OS of pazopanib (treatment group) to Temsirolimus (control group) as first line of treatment. HR \>1 treatment group performed better, \< 1 the control group performed better =1 groups performed equally.|||1.93|0.7|
74024675|NCT04321343|147601787|SUPERIORITY||Mean Difference (Final Values)|-25.313|STANDARD_ERROR_OF_MEAN|9.587||0.0083|TWO_SIDED|95.0|-44.1036|-6.5227|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-6.5227|-44.1036|0.0083
73853189|NCT01667224|147254887|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
73853190|NCT01667224|147254888|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
73853191|NCT01667224|147254889|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
73853192|NCT01667224|147254890|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
73853193|NCT02752633|147254948|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Data are presented as the urinary DHA excretion (mg/24 hr) and as the DHA-to-creatinine ratio (mg/mmol) in first morning void urine samples. Data are presented as a median (range). Differences in the median urinary DHA excretion and the urinary DHA-to-creatinine ratio between periods off pharmacotherapy and on the two study drugs, febuxostat and allopurinol, were assessed using the Wilcoxon signed rank test.||||<.05
73903136|NCT00491556|147336658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|12.39||0.4029|TWO_SIDED|95.0|-7.56|3.16|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||3.16|-7.56|0.4029
73903137|NCT00491556|147336659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|STANDARD_DEVIATION|6.03|<|0.0001|TWO_SIDED|95.0|11.99|17.21|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.21|11.99|< 0.0001
73903138|NCT00491556|147336660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.14|STANDARD_DEVIATION|6.2||0.0239|TWO_SIDED|95.0|-5.81|-0.46|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.46|-5.81|0.0239
73853194|NCT00853242|147254967|SUPERIORITY_OR_OTHER|||||||0.0249|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.0249
73853195|NCT00853242|147254967|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.0001
73853196|NCT00853242|147254967|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||<0.0001
73853197|NCT00853242|147254968|SUPERIORITY_OR_OTHER|||||||0.2647|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.2647
73853198|NCT00853242|147254968|SUPERIORITY_OR_OTHER|||||||0.7944|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.7944
73853199|NCT00853242|147254968|SUPERIORITY_OR_OTHER|||||||0.3724|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.3724
73853200|NCT03497975|147254972|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0309|TWO_SIDED|95.0|1.07|4.13||Logistic regression model includes WI-NRS baseline score as a covariate, treatment and the study site (with pooling) as a fixed effect.|Regression, Logistic|||||4.13|1.07|0.0309
73853201|NCT03497975|147254973|SUPERIORITY||Difference in LS Mean|-7.06|STANDARD_ERROR_OF_MEAN|1.91||0.0002|TWO_SIDED|95.0|-10.82|-3.3||Repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline ItchyQoL value. An unstructured covariance matrix is used.|Mixed Model for Repeated Measurements|||||-3.30|-10.82|0.0002
73853202|NCT03497975|147254974|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0179|TWO_SIDED|95.0|1.11|3.07||Logistic regression model includes PAS (Item 5a) baseline score as a covariate, treatment as a fixed effect and the study site (with pooling) as a fixed effect.|Regression, Logistic|||||3.07|1.11|0.0179
73853203|NCT03497975|147254975|SUPERIORITY||Difference in LS Mean|-4.43|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|-6.55|-2.31||Repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline PROMIS value. An unstructured covariance matrix is used.|Mixed Model for Repeated Measurements|||||-2.31|-6.55|<0.0001
73853204|NCT01500252|147255004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||95.0|||||t-test, 2 sided|||||||0.59
73853205|NCT01500252|147255005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83||95.0|||||t-test, 2 sided|||||||0.83
73853206|NCT01500252|147255007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
73962269|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1584|TWO_SIDED|95.0|0.95|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8||1.38|0.95|0.1584
73971053|NCT02969707|147482293|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.454|||||||t-test, 2 sided|||Pre- to post-rTMS change in SOARS scores were calculated for both Active and Sham conditions. Two-tailed t-tests were used to evaluate the difference between the two conditions' change scores.||||=.454
73903139|NCT00491556|147336661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.35|STANDARD_DEVIATION|10.26|<|0.0001|TWO_SIDED|95.0|-23.79|-14.91|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-14.91|-23.79|< 0.0001
73903140|NCT00491556|147336662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.45|STANDARD_DEVIATION|13.6||0.2363|TWO_SIDED|95.0|-9.33|2.43|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||2.43|-9.33|0.2363
73903141|NCT00491556|147336663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.69|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.0|15.93|23.45|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||23.45|15.93|< 0.0001
73903142|NCT00491556|147336664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|5.55||0.0929|TWO_SIDED|95.0|-4.43|0.37|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.37|-4.43|0.0929
73903143|NCT00491556|147336665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|STANDARD_DEVIATION|8.94||0.1886|TWO_SIDED|95.0|-6.4|1.34|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||1.34|-6.40|0.1886
73962270|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.3||||0.006||95.0|1.08|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8||1.58|1.08|0.0060
73853207|NCT01500252|147255008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||95.0|||||t-test, 2 sided|||||||0.39
73853208|NCT01500252|147255009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
73853209|NCT01500252|147255010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||95.0|||||t-test, 2 sided|||||||0.71
73853210|NCT01500252|147255011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||95.0|||||t-test, 2 sided|||||||0.98
73853211|NCT01500252|147255012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0|||||t-test, 2 sided|||||||0.35
73962271|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1117|TWO_SIDED|95.0|0.96|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16||1.46|0.96|0.1117
73853212|NCT01500252|147255013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Chi-squared|||||||0.31
73853213|NCT03115827|147255018|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
73853214|NCT05319600|147255019|SUPERIORITY|treatment group as predictor baseline-residualized week 12 scores in linear regression|Slope|129.2|STANDARD_ERROR_OF_MEAN|73.96|<|0.05|TWO_SIDED|95.0|-22.52|280.98|||Regression, Linear||Control coded as 0 and treatment as 1|||280.98|-22.52|<0.05
73853215|NCT00323960|147255020|SUPERIORITY|||||||0.0228||||||For multiple hypothesis testing, we used Bonferroni's correction (with n=3 posterior comparisons).|Chi-squared|To assess proportions we used the χ² test or Fisher's exact test||We calculated that a sample size of 40 patients would be needed in each study group (total 120 patients) to have 80% power for comparison of combination treatments (prednisone plus methotrexate or prednisone plus ciclosporin) with the reference treatment (prednisone alone).||||0.0228
73853216|NCT00323960|147255021|SUPERIORITY||Relative risk|2.45||||0.012|TWO_SIDED|95.0|1.2|5.0|||Log Rank||RR related to prednisone plus methotrexate arm (group 3) versus prednisone alone (group 1) and prednisone plus ciclosporin (group 2).|We used the Kaplan-Meier method to produce survival curves (groups 1 and 2 versus group 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||5.0|1.2|0.012
73853217|NCT00323960|147255022|SUPERIORITY||Relative risk|1.95||||0.009|TWO_SIDED|95.0|1.2|3.15|||Log Rank||RR related to prednisone alone (group 1) versus prednisone plus ciclosporin (group 2) and prednisone plus methotrexate arm (group 3).|We used the Kaplan-Meier method to produce survival curves (group 1 versus groups 2 and 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||3.15|1.2|0.009
73853218|NCT00323960|147255023|SUPERIORITY||Relative risk|1.65||||0.002|TWO_SIDED|95.0|1.24|2.14|||Log Rank||RR related to prednisone+methotrexate arm or prednisone+ciclosporin versus prednisone alone.|We used the Kaplan-Meier method to produce survival curves (groups 2 and 3 versus group 1) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||2.14|1.24|0.002
73853219|NCT00323960|147255023|SUPERIORITY||Relative risk|1.65||||0.002|TWO_SIDED|95.0|1.24|2.14|||Log Rank||RR related to prednisone alone (group 1) versus prednisone plus ciclosporin (group 2) and prednisone plus methotrexate arm (group 3).|We used the Kaplan-Meier method to produce survival curves (groups 1 versus groups 2 and 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||2.14|1.24|0.002
73853220|NCT00810771|147255036|SUPERIORITY_OR_OTHER|||||||0.873|TWO_SIDED||||||Chi-squared|||||||0.873
73853221|NCT00810771|147255037|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||Chi-squared|||||||0.671
73853222|NCT00810771|147255038|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
73853223|NCT00810771|147255039|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||Chi-squared|||||||0.186
73853224|NCT00810771|147255040|SUPERIORITY_OR_OTHER|||||||0.576|TWO_SIDED||||||Chi-squared|||||||0.576
73853225|NCT00810771|147255041|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Chi-squared|||||||0.35
73853226|NCT02059499|147255058|SUPERIORITY|||||||0.1877||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.1877
73853227|NCT02059499|147255059|SUPERIORITY|||||||0.1068||||||A priori threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.1068
73853228|NCT02059499|147255060|SUPERIORITY|||||||0.8071||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.8071
73853229|NCT02059499|147255061|SUPERIORITY|||||||0.6562||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.6562
73853230|NCT02059499|147255062|SUPERIORITY|||||||0.0141||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.0141
73903144|NCT00491556|147336666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87|STANDARD_DEVIATION|8.13||0.2831|TWO_SIDED|95.0|-1.65|5.38|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||5.38|-1.65|0.2831
73903145|NCT00491556|147336667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.52|STANDARD_DEVIATION|5.59|<|0.0001|TWO_SIDED|95.0|9.1|13.94|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||13.94|9.10|< 0.0001
73903146|NCT00491556|147336668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.21|STANDARD_DEVIATION|5.88||0.0157|TWO_SIDED|95.0|-5.75|-0.67|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.67|-5.75|0.0157
73903147|NCT00491556|147336669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.65|STANDARD_DEVIATION|12.93|<|0.0001|TWO_SIDED|95.0|-28.24|-17.06|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-17.06|-28.24|< 0.0001
73903148|NCT00491556|147336670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|STANDARD_DEVIATION|15.37||0.1999|TWO_SIDED|95.0|-2.41|10.88|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||10.88|-2.41|0.1999
73903149|NCT00491556|147336671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.47|STANDARD_DEVIATION|6.81|<|0.0001|TWO_SIDED|95.0|9.52|15.41|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||15.41|9.52|< 0.0001
73903150|NCT00491556|147336672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_DEVIATION|5.12||0.0808|TWO_SIDED|95.0|-4.17|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.26|-4.17|0.0808
73903151|NCT00491556|147336673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_DEVIATION|13.83||0.0005|TWO_SIDED|95.0|5.72|17.69|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.69|5.72|0.0005
73903152|NCT00491556|147336674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|14.12||0.9198|TWO_SIDED|95.0|-6.41|5.81|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||5.81|-6.41|0.9198
73903153|NCT00491556|147336675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69|STANDARD_DEVIATION|2.97|<|0.0001|TWO_SIDED|95.0|2.4|4.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||4.97|2.40|< 0.0001
73903154|NCT00491556|147336676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_DEVIATION|2.54||0.0215|TWO_SIDED|95.0|-2.41|-0.21|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.21|-2.41|0.0215
73903155|NCT00734747|147336697|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.001
73903156|NCT00396032|147336701|SUPERIORITY_OR_OTHER|||||||0.0044||95.0||||Stratified by baseline BFR: 0-199 mL/min, 200-274 mL/min, and 275-299 mL/min.|Cochran-Mantel-Haenszel|||||||0.0044
73962272|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1004|TWO_SIDED|95.0|0.97|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16||1.47|0.97|0.1004
73903157|NCT00396032|147336701|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||Chi-squared|||||||0.0035
73903158|NCT00396032|147336703|SUPERIORITY_OR_OTHER|||||||0.0396||95.0||||Stratified by baseline BFR: 0-199 mL/min, 200-274 mL/min, and 275-299 mL/min.|Cochran-Mantel-Haenszel|||||||0.0396
73903159|NCT01373489|147336743|SUPERIORITY||Mean Difference (Final Values)|10.0|||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
73903160|NCT00076024|147336747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.237||||0.156|TWO_SIDED|95.0|0.819|1.867|||Log Rank|One-sided log-rank test at alpha = 0.1 significance level was used.||P-value was calculated using one-sided Log rank test, stratified for estrogen receptor (ER) status (ER-positive or ER-negative/unknown), prior adjuvant chemotherapy (yes or no), and Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to \[=\<1\] or 2). The stratified Cox proportional hazards model was fitted, using the same stratification variables as above.||1.867|0.819|0.156
73903161|NCT00076024|147336748|SUPERIORITY_OR_OTHER||Difference in response rates|17.4||||0.038|TWO_SIDED|95.0|3.0|31.9|||Fisher Exact|||||31.9|3.0|0.038
73903162|NCT01155219|147336753|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
73962273|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.05||||0.6258|TWO_SIDED|95.0|0.87|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24||1.25|0.87|0.6258
73962274|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.16||||0.1154|TWO_SIDED|95.0|0.96|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24||1.39|0.96|0.1154
73962275|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8018|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32||1.22|0.86|0.8018
73962276|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5697|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32||1.26|0.88|0.5697
73962277|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9557|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40||1.20|0.84|0.9557
73962278|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8553|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40||1.22|0.85|0.8553
73962279|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9901|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48||1.20|0.84|0.9901
73903163|NCT03981822|147336775|SUPERIORITY|||||||0.0048||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Part B summary is pooled with its respective treatments from Part A.||||0.0048
74024676|NCT04321343|147601787|SUPERIORITY||Mean Difference (Final Values)|-21.003|STANDARD_ERROR_OF_MEAN|9.287||0.0237|TWO_SIDED|95.0|-39.2074|-2.7991|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-2.7991|-39.2074|0.0237
74024677|NCT04321343|147601787|SUPERIORITY||Mean Difference (Final Values)|-23.748|STANDARD_ERROR_OF_MEAN|9.053||0.0087|TWO_SIDED|95.0|-41.4923|-6.0035|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-6.0035|-41.4923|0.0087
74024678|NCT04321343|147601788|SUPERIORITY||Hodges-Lehmann midpoint estimate|-26.226|STANDARD_ERROR_OF_MEAN|10.252||0.0105|TWO_SIDED|95.0|-46.3208|-6.1313|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-6.1313|-46.3208|0.0105
74024679|NCT04321343|147601788|SUPERIORITY||Hodges-Lehmann midpoint estimate|-21.496|STANDARD_ERROR_OF_MEAN|9.873||0.0295|TWO_SIDED|95.0|-40.8475|-2.1451|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-2.1451|-40.8475|0.0295
73853231|NCT02059499|147255063|SUPERIORITY|||||||0.0141||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.0141
73853232|NCT02059499|147255067|SUPERIORITY|||||||0.1409||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.1409
73853233|NCT02059499|147255068|SUPERIORITY|||||||0.0805||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.0805
73853234|NCT02059499|147255070|SUPERIORITY|||||||0.5726|||||||Cochran-Mantel-Haenszel|||||||0.5726
73853235|NCT02059499|147255071|SUPERIORITY|||||||0.6184||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.6184
73853236|NCT02059499|147255073|EQUIVALENCE|Comparison of mean between count of hrHPV genotypes observed at baseline vs at week 20 in imiquimod arm||||||0.3||||||A priori threshold for interpreting significance : 0.05|Wilcoxon (Mann-Whitney)|||Comparison of number of hrHPV genotypes in each arm observed at baseline vs at week 20 in imiquimod arm||||0.3
73853237|NCT02059499|147255073|EQUIVALENCE|Comparison of mean number of hrHPV genotypes observed at baseline vs at week 20 in 5FU arm||||||0.3||||||A priori threshold to interpret significance: 0.05|Wilcoxon (Mann-Whitney)|||Comparison of the count of hrHPV genotypes observed at baseline vs at week 20 in 5FU arm||||0.3
73853238|NCT02059499|147255073|EQUIVALENCE|Comparison of mean number of hrHPV genotypes observed at baseline vs at week 20 in observation arm||||||0.26||||||A priori cutoff of significance: 0.05|Wilcoxon (Mann-Whitney)|||Comparison of the count of hrHPV genotypes observed at baseline vs at week 20 in observation arm||||0.26
73853239|NCT03989349|147255075|OTHER||Strata-adjusted percentage difference|12.2||||0.0006|TWO_SIDED|97.5|4.6|19.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||19.8|4.6|0.0006
73853240|NCT03989349|147255076|OTHER||Strata-adjusted percentage difference|14.9||||0.0008|TWO_SIDED|97.5|5.6|24.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.3|5.6|0.0008
73853241|NCT03989349|147255077|OTHER||Strata-adjusted percentage difference|12.5||||0.0006|TWO_SIDED|97.5|4.6|20.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||20.3|4.6|0.0006
73853242|NCT03989349|147255078|OTHER||Strata-adjusted percentage difference|16.3||||0.0004|TWO_SIDED|97.5|6.6|26.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.0|6.6|0.0004
73853243|NCT03989349|147255079|OTHER||Strata-adjusted percentage difference|23.2|||<|0.0001|TWO_SIDED|97.5|16.1|30.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||30.3|16.1|<0.0001
73903164|NCT03981822|147336775|SUPERIORITY|||||||0.0075||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Part B summary is pooled with its respective treatments from Part A.||||0.0075
73903165|NCT03981822|147336776|SUPERIORITY|||||||0.3642||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2 - Part B summary is pooled with its respective treatments from Part A.||||0.3642
74024680|NCT04321343|147601788|SUPERIORITY||Hodges-Lehmann midpoint estimate|-24.29|STANDARD_ERROR_OF_MEAN|9.746||0.0127|TWO_SIDED|95.0|-43.392|-5.1884|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-5.1884|-43.3920|0.0127
74024681|NCT04321343|147601789|SUPERIORITY||Mean Difference (Final Values)|-4.671|STANDARD_ERROR_OF_MEAN|1.824||0.0105|TWO_SIDED|95.0|-8.2463|-1.0957|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-1.0957|-8.2463|0.0105
74024682|NCT04321343|147601789|SUPERIORITY||Mean Difference (Final Values)|-4.097|STANDARD_ERROR_OF_MEAN|1.743||0.0188|TWO_SIDED|95.0|-7.514|-0.6799|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-0.6799|-7.5140|0.0188
73853244|NCT03989349|147255079|OTHER||Strata-adjusted percentage difference|27.8|||<|0.0001|TWO_SIDED|97.5|21.2|34.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption.||34.5|21.2|<0.0001
73853245|NCT03989349|147255080|OTHER||Strata-adjusted percentage difference|27.1|||<|0.0001|TWO_SIDED|97.5|17.5|36.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||36.6|17.5|<0.0001
73853246|NCT03989349|147255080|OTHER||Strata-adjusted percentage difference|33.4|||<|0.0001|TWO_SIDED|97.5|24.5|42.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using MI-MAR assumption.||42.3|24.5|<0.0001
73853247|NCT03989349|147255081|OTHER||Strata-adjusted percentage difference|17.1|||<|0.0001|TWO_SIDED|97.5|10.9|23.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||23.3|10.9|<0.0001
73853248|NCT03989349|147255082|OTHER||Strata-adjusted percentage difference|18.4|||<|0.0001|TWO_SIDED|97.5|11.0|25.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||25.8|11.0|<0.0001
73853249|NCT03989349|147255083|OTHER||Strata-adjusted percentage difference|17.5|||<|0.0001|TWO_SIDED|97.5|10.8|24.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.3|10.8|< 0.0001
73853250|NCT03989349|147255084|OTHER||Strata-adjusted percentage difference|21.9|||<|0.0001|TWO_SIDED|97.5|12.5|31.4||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||31.4|12.5|<0.0001
73853251|NCT03989349|147255085|OTHER||Strata-adjusted percentage difference|20.9|||<|0.0001|TWO_SIDED|97.5|15.6|26.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting the randomized stratification variables (IGA severity and PP NRS).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.1|15.6|< 0.0001
73853252|NCT03989349|147255086|OTHER||Strata-adjusted percentage difference|22.5|||<|0.0001|TWO_SIDED|97.5|15.0|29.9||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||29.9|15.0|<0.0001
73903166|NCT03981822|147336776|SUPERIORITY|||||||0.0967||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0967
73903167|NCT03981822|147336776|SUPERIORITY|||||||0.0648||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0648
74024683|NCT04321343|147601789|SUPERIORITY||Mean Difference (Final Values)|-4.321|STANDARD_ERROR_OF_MEAN|1.689||0.0105|TWO_SIDED|95.0|-7.6307|-1.0104|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-1.0104|-7.6307|0.0105
74024684|NCT04321343|147601790|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1634|TWO_SIDED|95.0|0.677|10.087|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||10.087|0.677|0.1634
74024685|NCT04321343|147601790|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0722|TWO_SIDED|95.0|0.899|11.831|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||11.831|0.899|0.0722
74024686|NCT04321343|147601790|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0703|TWO_SIDED|95.0|0.909|11.052|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||11.052|0.909|0.0703
74024687|NCT04321343|147601791|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|8.2||0.4318|TWO_SIDED|95.0|-22.66|9.72|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||9.72|-22.66|0.4318
73903168|NCT03981822|147336776|SUPERIORITY|||||||0.1357||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.1357
73853253|NCT03989349|147255087|OTHER||Strata-adjusted percentage difference|13.2|||<|0.0001|TWO_SIDED|97.5|9.0|17.4||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||17.4|9|< 0.0001
73853254|NCT03989349|147255088|OTHER||Strata-adjusted percentage difference|9.9||||0.0001|TWO_SIDED|97.5|5.5|14.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||14.3|5.5|0.0001
73853255|NCT03989349|147255089|OTHER||Strata-adjusted percentage difference|15.1|||<|0.0001|TWO_SIDED|97.5|11.0|19.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level||19.2|11|< 0.0001
73853256|NCT03989349|147255090|OTHER||Strata-adjusted percentage difference|16.3|||<|0.0001|TWO_SIDED|97.5|10.5|22.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.1|10.5|<0.0001
73853257|NCT03989349|147255091|OTHER||Strata-adjusted percentage difference|6.4|||<|0.0001|TWO_SIDED|97.5|3.8|9.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||9.1|3.8|<0.0001
73903169|NCT03981822|147336776|SUPERIORITY|||||||0.019||||||P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from|Cochran-Mantel-Haenszel|||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0190
73903170|NCT03981822|147336776|SUPERIORITY|||||||0.0184||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0184
73853258|NCT03989349|147255092|OTHER||Strata-adjusted percentage difference|8.0||||0.0004|TWO_SIDED|97.5|4.2|11.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for preceding outcome measure was statistically significant at two-sided 2.5% significance level.||11.8|4.2|0.0004
73853259|NCT01352221|147255093|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|ONE_SIDED|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|||1.81|< 0.0001
73853260|NCT01352221|147255097|SUPERIORITY||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|ONE_SIDED|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|||0.82|< 0.0001
73853261|NCT01352221|147255098|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|ONE_SIDED|97.5|1.43|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|ANCOVA||||||1.43|< 0.0001
73853262|NCT01352221|147255109|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|ONE_SIDED|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|||1.87|< 0.0001
73853263|NCT01352221|147255110|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|ONE_SIDED|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF Change in Haemoglobin Concentration from Baseline to Week 12|||1.82|< 0.0001
73853264|NCT02016716|147255119|NON_INFERIORITY|Non-inferiority was claimed if the lower bound of the 1-sided 97.5% CI (or the lower bound of 2-sided 95% CI) of the mean difference between the 2 romosozumab groups was \> -2.0%.|Least Squares Mean Difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.7|||||Based on ANCOVA model adjusting for treatment, and baseline lumbar spine BMD T-score.|The primary hypothesis was that the mean percent change from baseline in lumbar spine BMD at month 6 in participants receiving romosozumab 210 mg QM using the 90 mg/mL concentration would not be inferior to that in participants receiving romosozumab 210 mg QM using the 70 mg/mL concentration.||0.7|-1.5|
73853265|NCT02248649|147255124|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|covariates: baseline age and years of education||||||0.2
73853266|NCT02248649|147255125|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
73853267|NCT02248649|147255126|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
73903171|NCT03981822|147336776|SUPERIORITY|||||||0.0048||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.||||0.0048
73903172|NCT03981822|147336776|SUPERIORITY|||||||0.0075||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.||||0.0075
73903173|NCT03981822|147336776|SUPERIORITY|||||||0.0539||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.||||0.0539
73903174|NCT03981822|147336776|SUPERIORITY|||||||0.1638||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.||||0.1638
73903175|NCT03981822|147336776|SUPERIORITY|||||||0.4766||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.||||0.4766
73903176|NCT03981822|147336776|SUPERIORITY|||||||0.1588||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.||||0.1588
74024688|NCT04321343|147601791|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|8.0||0.8382|TWO_SIDED|95.0|-17.37|14.1|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||14.10|-17.37|0.8382
74024689|NCT04321343|147601791|SUPERIORITY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|7.7||0.4982|TWO_SIDED|95.0|-9.92|20.33|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||20.33|-9.92|0.4982
74024690|NCT04321343|147601792|SUPERIORITY||Odds Ratio (OR)|0.72||||0.7137|TWO_SIDED|95.0|0.131|3.935|||Cochran-Mantel-Haenszel|||||3.935|0.131|0.7137
74024691|NCT04321343|147601792|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0597|TWO_SIDED|95.0|0.937|14.58|||Cochran-Mantel-Haenszel|||||14.580|0.937|0.0597
74024692|NCT04321343|147601792|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1749|TWO_SIDED|95.0|0.655|10.43|||Cochran-Mantel-Haenszel|||||10.430|0.655|0.1749
73903177|NCT03981822|147336777|SUPERIORITY|||||||0.3642||||||P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from Part A.|Cochran-Mantel-Haenszel|||Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.||||0.3642
73903178|NCT03981822|147336777|SUPERIORITY|||||||0.0356|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.||||0.0356
73903179|NCT03981822|147336777|SUPERIORITY|||||||0.0118|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0118
74024693|NCT04321343|147601793|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|8.8||0.7449|TWO_SIDED|95.0|-20.15|14.43|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||14.43|-20.15|0.7449
74084878|NCT04284553|147723129|SUPERIORITY||Mean Difference (Final Values)|-1.74|||||TWO_SIDED|95.0|-30.4|26.9|||||"The estimate compares having simplification as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having simplification in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||26.9|-30.4|
73853268|NCT00147017|147255161|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
73853269|NCT00147017|147255162|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
73853270|NCT00147017|147255163|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
73853271|NCT01221623|147255164|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||ANOVA|||||||.0059
73853272|NCT01221623|147255165|SUPERIORITY_OR_OTHER|||||||0.0496|TWO_SIDED||||||ANOVA|||||||.0496
73853273|NCT01221623|147255166|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
73853274|NCT01221623|147255167|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||ANOVA|||||||.0340
73853275|NCT01221623|147255168|SUPERIORITY_OR_OTHER|||||||0.1168|TWO_SIDED||||||ANOVA|||||||.1168
73853276|NCT01221623|147255169|SUPERIORITY_OR_OTHER|||||||0.0144|TWO_SIDED||||||ANOVA|||||||.0144
73853277|NCT01221623|147255170|SUPERIORITY_OR_OTHER|||||||0.0248|TWO_SIDED||||||ANOVA|||||||.0248
73853278|NCT01221623|147255171|SUPERIORITY_OR_OTHER|||||||0.6949|TWO_SIDED||||||ANOVA|||||||.6949
73853279|NCT01221623|147255172|SUPERIORITY_OR_OTHER|||||||0.0249|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||.0249
73853280|NCT03479541|147255173|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.097||||0.013|TWO_SIDED|95.0|-0.173|-0.02||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.020|-0.173|0.013
73853281|NCT03479541|147255174|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.073||||0.013|TWO_SIDED|95.0|-0.13|-0.016||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.016|-0.130|0.013
73853282|NCT03479541|147255175|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.098||||0.01|TWO_SIDED|95.0|0.024|0.173||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.173|0.024|0.010
73853283|NCT03479541|147255176|OTHER|||||||0.5158|||||||Wilcoxon (Mann-Whitney)|||||||0.5158
73903180|NCT03981822|147336777|SUPERIORITY|||||||0.0026||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day84 EOT Part B summary is pooled with its respective treatments from Part A.||||0.0026
73903181|NCT03981822|147336777|SUPERIORITY|||||||0.0174|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.||||0.0174
73903182|NCT03981822|147336777|SUPERIORITY|||||||0.1311|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.||||0.1311
73903183|NCT03981822|147336777|SUPERIORITY|||||||0.0967|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.||||0.0967
73903184|NCT03981822|147336777|SUPERIORITY|||||||0.1357|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.||||0.1357
73903185|NCT03981822|147336777|SUPERIORITY|||||||0.0184|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0184
73903186|NCT03981822|147336777|SUPERIORITY|||||||0.0024|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 EOT Visit Part B summary is pooled with its respective treatments from Part A.||||0.0024
73903187|NCT03981822|147336777|SUPERIORITY|||||||0.1034|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.||||0.1034
73903188|NCT03981822|147336777|SUPERIORITY|||||||0.1029|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.||||0.1029
73962280|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|0.95||||0.587|TWO_SIDED|95.0|0.8|1.14|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48||1.14|0.80|0.5870
73962281|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8302|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56||1.22|0.85|0.8302
73962282|NCT02528188|147460953|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4823|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56||1.12|0.79|0.4823
73962283|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.11||||0.2938|TWO_SIDED|95.0|0.92|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=30% reduction||1.33|0.92|0.2938
73903189|NCT03981822|147336778|SUPERIORITY|||||||0.0356|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0356
73903190|NCT03981822|147336778|SUPERIORITY|||||||0.1477|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.1477
73903191|NCT03981822|147336778|SUPERIORITY|||||||0.0062|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0062
73903192|NCT03981822|147336778|SUPERIORITY|||||||0.0046|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0046
73903193|NCT03981822|147336778|SUPERIORITY|||||||0.0177|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0177
73903194|NCT03981822|147336778|SUPERIORITY|||||||0.0054|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0054
73903195|NCT03981822|147336778|SUPERIORITY|||||||0.0013|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 (EOT) visit: Part B summary is pooled with its respective treatments from Part A.||||0.0013
73903196|NCT03981822|147336778|SUPERIORITY|||||||0.0034|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 (EOT) Visit: Part B summary is pooled with its respective treatments from Part A.||||0.0034
73903197|NCT03981822|147336778|SUPERIORITY|||||||0.0156|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0156
73903198|NCT03981822|147336778|SUPERIORITY|||||||0.0367|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0367
73903199|NCT03981822|147336778|SUPERIORITY|||||||0.1746|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||||0.1746
73903200|NCT03981822|147336778|SUPERIORITY|||||||0.0123|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||||0.0123
73962284|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.91||||0.3146|TWO_SIDED|95.0|0.75|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=30% reduction||1.10|0.75|0.3146
74024694|NCT04321343|147601793|SUPERIORITY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|8.6||0.7255|TWO_SIDED|95.0|-19.93|13.9|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||13.90|-19.93|0.7255
73962285|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0748|TWO_SIDED|95.0|0.98|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=50% reduction||1.58|0.98|0.0748
73962286|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3|TWO_SIDED|95.0|0.89|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=50% reduction||1.45|0.89|0.3000
74024695|NCT04321343|147601793|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|8.2||0.7755|TWO_SIDED|95.0|-13.89|18.59|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||18.59|-13.89|0.7755
73853284|NCT03479541|147255177|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0404||||0.45|TWO_SIDED|95.0|-0.0648|0.146||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.146|-0.0648|0.450
74024696|NCT04321343|147601794|SUPERIORITY||Odds Ratio (OR)|3.12||||0.1325|TWO_SIDED|95.0|0.703|13.806|||Cochran-Mantel-Haenszel|||||13.806|0.703|0.1325
74024697|NCT04321343|147601794|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9918|TWO_SIDED|95.0|0.201|4.898|||Cochran-Mantel-Haenszel|||||4.898|0.201|0.9918
74024698|NCT04321343|147601794|SUPERIORITY||Odds Ratio (OR)|4.78||||0.041|TWO_SIDED|95.0|1.053|21.714|||Cochran-Mantel-Haenszel|||||21.714|1.053|0.0410
73853285|NCT03479541|147255178|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time point (pre-physical therapy and post-physical therapy), and group x time point injury interaction with random intercepts, covariates (age, gender, Initial SCAT symptom severity total score, and days since injury before physical therapy), and inverse probability weights. Later Physical Therapy Group and pre-physical therapy time point served as the reference. Values were log-transformed for model assumptions.|Slope|0.05353||||0.6039|TWO_SIDED|95.0|-0.1503|0.2574||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change from pre-physical therapy to post-physical therapy time points (the interaction effect of the mixed model analysis).|Analysis for Horizontal DVA Lines Lost||0.2574|-0.1503|0.6039
73853286|NCT03479541|147255178|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time point (pre-physical therapy and post-physical therapy), and group x time point injury interaction with random intercepts, covariates (age, gender, Initial SCAT symptom severity total score, and days since injury before physical therapy), and inverse probability weights. Later Physical Therapy Group and pre-physical therapy time point served as the references. Values were log-transformed for model assumptions.|Slope|-0.235||||0.0414|TWO_SIDED|95.0|-0.461|-0.0093||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change from pre-physical therapy to post-physical therapy time points (the interaction effect of the mixed model analysis).|Analysis for Vertical DVA Lines Lost||-0.0093|-0.461|0.0414
73853287|NCT03479541|147255179|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.028||||0.387|TWO_SIDED|95.0|-0.09|0.035||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.035|-0.090|0.387
73853288|NCT03479541|147255180|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.008||||0.135|TWO_SIDED|95.0|-0.003|0.019||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.019|-0.003|0.135
73853289|NCT03479541|147255181|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0107||||0.406|TWO_SIDED|95.0|-0.036|0.0146||a priori threshold p \< 0.05|Mixed Models Analysis||||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|0.0146|-0.0360|0.406
73853290|NCT03479541|147255182|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00391||||0.083|TWO_SIDED|95.0|-0.00052|0.00835||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.00835|-0.00052|0.083
73853291|NCT03479541|147255183|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.003||||0.24|TWO_SIDED|95.0|-0.007|0.002||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for EcFi condition||0.002|-0.007|0.240
73903201|NCT03981822|147336779|SUPERIORITY||LS mean difference|-3.96||||0.0021|TWO_SIDED|95.0|-5.41|-1.24||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, Tx by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-1.24|-5.41|0.0021
73903202|NCT03981822|147336779|SUPERIORITY||LS mean difference|-4.72||||0.015|TWO_SIDED|95.0|-5.95|-0.66|||Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-0.66|-5.95|0.0150
73903203|NCT03981822|147336779|SUPERIORITY||LS mean difference|-5.31||||0.0011|TWO_SIDED|95.0|-6.54|-1.69||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-1.69|-6.54|0.0011
73903204|NCT03981822|147336779|SUPERIORITY||LS mean difference|-6.5||||0.0007|TWO_SIDED|95.0|-8.25|-2.32||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.||-2.32|-8.25|0.0007
73903205|NCT03981822|147336779|SUPERIORITY||LS mean difference|-6.15||||0.0012|TWO_SIDED|95.0|-7.5|-1.91||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.||-1.91|-7.50|0.0012
73903206|NCT03981822|147336779|SUPERIORITY||LS mean difference|-5.02||||0.0349|TWO_SIDED|95.0|-6.78|-0.26||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-0.26|-6.78|0.0349
73903207|NCT03981822|147336779|SUPERIORITY||LS mean difference|-4.76|||<|0.0001|TWO_SIDED|95.0|-7.47|-2.85||P-value is based on MMRM mode|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment visit 2: Part B summary is pooled with its respective treatments from Part A.||-2.85|-7.47|<0.0001
73903208|NCT03981822|147336779|SUPERIORITY||LS mean difference|-6.0||||0.0005|TWO_SIDED|95.0|-8.37|-2.43||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Degrees of freedom associated with the error term were computed using Kenward-Rogers method.||-2.43|-8.37|0.0005
73903209|NCT03981822|147336779|SUPERIORITY||LS mean difference|-6.64|||<|0.0001|TWO_SIDED|95.0|-9.65|-4.12||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment visit 4: Part B summary is pooled with its respective treatments from Part A.||-4.12|-9.65|<0.0001
73903210|NCT03981822|147336779|SUPERIORITY||LS mean difference|-6.49||||0.0004|TWO_SIDED|95.0|-9.67|-2.92||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||-2.92|-9.67|0.0004
73903211|NCT03981822|147336779|SUPERIORITY||LS mean difference|-6.96|||<|0.0001|TWO_SIDED|95.0|-9.89|-3.57||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.||-3.57|-9.89|<0.0001
73903212|NCT03981822|147336779|SUPERIORITY||LS mean difference|-6.99||||0.0005|TWO_SIDED|95.0|-10.2|-2.94||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-2.94|-10.20|0.0005
73903213|NCT03981822|147336780|SUPERIORITY||LS mean difference|-41.47|||<|0.0001|TWO_SIDED|95.0|-51.31|-20.87||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-20.87|-51.31|<0.0001
73903214|NCT03981822|147336780|SUPERIORITY||LS mean difference|-50.95||||0.0004|TWO_SIDED|95.0|-66.18|-19.56||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-19.56|-66.18|0.0004
73903215|NCT03981822|147336780|SUPERIORITY||LS mean difference|-66.21|||<|0.0001|TWO_SIDED|95.0|-88.15|-35.87||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-35.87|-88.15|<0.0001
73903216|NCT03981822|147336780|SUPERIORITY||LS mean difference|-79.37|||<|0.0001|TWO_SIDED|95.0|-111.44|-49.77||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.||-49.77|-111.44|<0.0001
73903217|NCT03981822|147336780|SUPERIORITY||LS mean difference|-69.79||||0.0001|TWO_SIDED|95.0|-103.17|-35.25||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up Day 112: Part B summary is pooled with its respective treatments from Part A.||-35.25|-103.17|0.0001
73903218|NCT03981822|147336780|SUPERIORITY||LS mean difference|-41.22||||0.1033|TWO_SIDED|95.0|-90.61|8.56||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||8.56|-90.61|0.1033
73903219|NCT03981822|147336780|SUPERIORITY||LS mean difference|-58.43|||<|0.0001|TWO_SIDED|95.0|-73.26|-39.39||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-39.39|-73.26|<0.0001
73903220|NCT03981822|147336780|SUPERIORITY||LS mean difference|-69.86|||<|0.0001|TWO_SIDED|95.0|-81.61|-28.8||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-28.80|-81.61|<0.0001
73903221|NCT03981822|147336780|SUPERIORITY||LS mean difference|-76.55|||<|0.0001|TWO_SIDED|95.0|-107.19|-45.61||P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-45.61|-107.19|<0.0001
73903222|NCT03981822|147336780|SUPERIORITY||LS mean difference|-74.29||||0.0003|TWO_SIDED|95.0|-102.96|-31.55||P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.||-31.55|-102.96|0.0003
73903223|NCT03981822|147336780|SUPERIORITY||LS mean difference|-77.1||||0.0004|TWO_SIDED|95.0|-110.32|-32.78||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||-32.78|-110.32|0.0004
73903224|NCT03981822|147336780|SUPERIORITY||LS mean difference|-77.52||||0.0178|TWO_SIDED|95.0|-120.82|-11.88||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||-11.88|-120.82|0.0178
73903225|NCT03981822|147336781|SUPERIORITY|||||||0.0004||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0004
73903226|NCT03981822|147336781|SUPERIORITY|||||||0.0005||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0005
73903227|NCT03981822|147336781|SUPERIORITY|||||||0.0698||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0698
73903228|NCT03981822|147336781|SUPERIORITY|||||||0.01||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0100
73903229|NCT03981822|147336781|SUPERIORITY|||||||0.0101||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0101
73903230|NCT03981822|147336781|SUPERIORITY|||||||0.0077||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0077
73903231|NCT03981822|147336781|SUPERIORITY|||||||0.064||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.||||0.0640
73903232|NCT03981822|147336781|SUPERIORITY|||||||0.0045||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT: Part B summary is pooled with its respective treatments from Part A.||||0.0045
73903233|NCT03981822|147336781|SUPERIORITY|||||||0.284||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||||0.2840
73903234|NCT03981822|147336781|SUPERIORITY|||||||0.0132||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0132
73903235|NCT03981822|147336781|SUPERIORITY|||||||0.4668||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.||||0.4668
73903236|NCT03981822|147336781|SUPERIORITY|||||||0.0064||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.||||0.0064
73903237|NCT03981822|147336782|SUPERIORITY|||||||0.0364|||||||Mantel Haenszel|Stratified by gender||Part B summary is pooled with its respective treatments from Part A.||||0.0364
74084879|NCT04284553|147723129|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-37.6|17.4|||||"The estimate compares having sign-off approval as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having sign-off approval in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||17.4|-37.6|
73903238|NCT03981822|147336782|SUPERIORITY|||||||0.0215|||||||Cochran-Mantel-Haenszel|Stratified by gender||Part B summary is pooled with its respective treatments from Part A.||||0.0215
73903239|NCT03981822|147336783|SUPERIORITY||LS mean difference|-59.63||||0.1222|TWO_SIDED|95.0|-76.1|9.23||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT: Part B summary is pooled with its respective treatments from Part A.||9.23|-76.10|0.1222
73903240|NCT03981822|147336783|SUPERIORITY||LS mean difference|-69.51||||0.0403|TWO_SIDED|95.0|-81.3|-1.9||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 112 (EOT: Part B summary is pooled with its respective treatments from Part A.||-1.90|-81.30|0.0403
73903241|NCT03981822|147336783|SUPERIORITY||LS mean difference|-58.88||||0.0863|TWO_SIDED|95.0|-77.79|5.33||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||5.33|-77.79|0.0863
73962287|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.23||||0.255|TWO_SIDED|95.0|0.86|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=70% reduction||1.74|0.86|0.2550
73962288|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.14||||0.478|TWO_SIDED|95.0|0.8|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=70% reduction||1.62|0.80|0.4780
73962289|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4006|TWO_SIDED|95.0|0.7|2.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=90% reduction||2.42|0.70|0.4006
73962290|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3089|TWO_SIDED|95.0|0.74|2.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=90% reduction||2.54|0.74|0.3089
73962291|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0114|TWO_SIDED|95.0|1.05|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=30% reduction||1.50|1.05|0.0114
73962292|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.23||||0.0239|TWO_SIDED|95.0|1.03|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=30% reduction||1.47|1.03|0.0239
73903242|NCT03981822|147336783|SUPERIORITY||LS mean difference|-62.13||||0.0428|TWO_SIDED|95.0|-100.76|-1.73||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||-1.73|-100.76|0.0428
73903243|NCT03981822|147336783|SUPERIORITY||LS mean difference|-71.93||||0.0084|TWO_SIDED|95.0|-110.46|-17.0||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||-17.00|-110.46|0.0084
73903244|NCT03981822|147336783|SUPERIORITY||LS mean difference|-63.11||||0.0273|TWO_SIDED|95.0|-103.08|-6.35||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-6.35|-103.08|0.0273
73903245|NCT03981822|147336784|SUPERIORITY|Analysis is based on MMRM model|LS mean difference|-44.65||||0.3083|TWO_SIDED|95.0|-69.96|22.47|||Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||22.47|-69.96|0.3083
73962293|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0079|TWO_SIDED|95.0|1.07|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=50% reduction||1.60|1.07|0.0079
73903246|NCT03981822|147336784|SUPERIORITY||LS mean difference|-55.8||||0.1686|TWO_SIDED|95.0|-86.93|15.56||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||15.56|-86.93|0.1686
73903247|NCT03981822|147336784|SUPERIORITY||LS mean difference|-38.06||||0.2384|TWO_SIDED|95.0|-87.04|22.1||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||22.10|-87.04|0.2384
73903248|NCT03981822|147336784|SUPERIORITY||LS mean difference|-61.96||||0.0603|TWO_SIDED|95.0|-103.37|2.27||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||2.27|-103.37|0.0603
73903249|NCT03981822|147336784|SUPERIORITY||LS mean difference|-74.87||||0.0109|TWO_SIDED|95.0|-138.71|-18.83||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||-18.83|-138.71|0.0109
73903250|NCT03981822|147336784|SUPERIORITY||LS mean difference|-66.62||||0.0467|TWO_SIDED|95.0|-127.64|-0.99||Analysis is base on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||-0.99|-127.64|0.0467
73903251|NCT06460493|147336785|OTHER|The proportion of subjects classified as responders at week 12, standard errors, and corresponding 95% CI was estimated by negative binomial regression with background therapy (LABA/LAMA or LABA/LAMA/ICS) included as a fixed effect, and with baseline CAT score included as a covariate. The scale parameter in the negative binomial model was held fixed by specifying a noscale option.|Negative binomial regression|67.0|||||TWO_SIDED|95.0|38.0|100.0|||||A two-sided unadjusted 95% confidence interval for the proportion was used to determine study success with the lower bound of the CI \> 0 indicating success.|||100.0|38.0|
73903252|NCT06460493|147336786|OTHER|The proportion of subjects classified as responders at week 6, standard errors, and corresponding 95% CI was estimated by negative binomial regression with background therapy (LABA/LAMA or LABA/LAMA/ICS) included as a fixed effect, and with baseline CAT score included as a covariate. The scale parameter in the negative binomial model was held fixed by specifying a noscale option.|Negative binomial regression|44.4|||||TWO_SIDED|95.0|22.0|89.5|||||A two-sided unadjusted 95% confidence interval for the proportion was used to determine study success with the lower bound of the CI \> 0 indicating success.|||89.5|22.0|
73903253|NCT02882074|147336813|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.158|TWO_SIDED|95.0|-0.11|0.64|||Regression, Linear|||||0.64|-0.11|0.158
73903254|NCT02882074|147336814|SUPERIORITY||Ratio of geometric means|0.86||||0.388|TWO_SIDED|97.5|0.57|1.28||The significance criterion is p-value \< 0.025 (i.e. 0.05/2), corrected for multiple comparisons.|Mixed Models Analysis||Syndecan values were all log-transformed to meet the linearity requirement. Thus the treatment effect was presented as the ratio of geometric means.|||1.28|0.57|0.388
73903255|NCT02882074|147336815|SUPERIORITY||Ratio of geometric means|1.19||||0.257|TWO_SIDED|97.5|0.84|1.68||The significance criterion is p-value \< 0.025 (i.e. 0.05/2), corrected for multiple comparisons.|Mixed Models Analysis||Endocan values were all log-transformed to meet the linearity requirement. Thus the treatment effect was presented as the ratio of geometric means.|||1.68|0.84|0.257
73903256|NCT02882074|147336816|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.003|TWO_SIDED|95.0|0.23|1.01|||Regression, Linear|||||1.01|0.23|0.003
73903257|NCT04543409|147336845|SUPERIORITY||Odds Ratio (OR)|117.49|||<|0.0001|TWO_SIDED|95.0|38.17|361.64|||Cochran-Mantel-Haenszel||The OR estimate and p-value was obtained from the CMH test controlling for region (North America and Rest of the world), baseline steroid use, and presence of strictures at baseline. Odds ratio values \>1 favor Benra 30 mg treatment group.|Analysis completed at Week 24.||361.64|38.17|<0.0001
73903258|NCT04543409|147336846|SUPERIORITY|For any patients with intercurrent events, the DSQ scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.|Difference in Least Squares Means|2.999||||0.177|TWO_SIDED|95.0|-1.36|7.35|||ANCOVA|Model: Change from baseline in DSQ = Treatment + baseline DSQ + Region + Baseline steroid use + Presence of strictures at baseline.||Analysis completed at Week 24.||7.35|-1.36|0.1770
74024699|NCT04321343|147601795|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|10.3||0.4413|TWO_SIDED|95.0|-28.25|12.36|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||12.36|-28.25|0.4413
73903259|NCT04543409|147336847|SUPERIORITY|For any patients with intercurrent events, the Peak Esophageal intraepithelial eosinophil (eos) counts after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-96.2|||<|0.0001|TWO_SIDED|95.0|-114.53|-77.85|||ANCOVA|Model: Percent change from baseline in Peak Esophageal intraepithelial eos counts = Treatment + baseline Peak Esophageal intraepithelial eos counts.||Analysis completed at Week 24.||-77.85|-114.53|<0.0001
73903260|NCT04543409|147336848|SUPERIORITY|For any patients with intercurrent events, the EoE-HSS total grade score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.175|||<|0.0001|TWO_SIDED|95.0|-0.21|-0.14|||ANCOVA|Change from baseline in EoE-HSS TGS = Treatment + baseline EoE-HSS grade score + Region + Baseline steroid use + Presence of strictures at baseline||||-0.14|-0.21|<0.0001
73903261|NCT04543409|147336849|SUPERIORITY|For any patients with intercurrent events, the EoE-HSS total stage score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.122|||<|0.0001|TWO_SIDED|95.0|-0.16|-0.09|||ANCOVA|Change from baseline in EoE-HSS TSS = Treatment + baseline EoE-HSS stage score + Region + Baseline steroid use + Presence of strictures at baseline||||-0.09|-0.16|<0.0001
73962294|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0068|TWO_SIDED|95.0|1.08|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=50% reduction||1.60|1.08|0.0068
73962295|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1037|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=70% reduction||1.62|0.96|0.1037
73962296|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0046|TWO_SIDED|95.0|1.12|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=70% reduction||1.88|1.12|0.0046
74024700|NCT04321343|147601795|SUPERIORITY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|10.2||0.0859|TWO_SIDED|95.0|-37.63|2.5|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.50|-37.63|0.0859
73903262|NCT04543409|147336850|SUPERIORITY|For any patients with intercurrent events, the centrally-read EREFS total score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.1||||0.7322|TWO_SIDED|95.0|-0.52|0.32|||ANCOVA|Model: Change from baseline in EREFS TS = Treatment + baseline EREFS TS + Region + Baseline steroid use + Presence of strictures at baseline||Analysis completed at Week 24.||0.32|-0.52|0.7322
73903263|NCT04543409|147336851|SUPERIORITY||Odds Ratio (OR)|15.86|||<|0.0001|TWO_SIDED|95.0|5.79|43.47|||Cochran-Mantel-Haenszel||Controlling for region (North America and Rest of the world), baseline steroid use, and presence of strictures at baseline. OR values \>1 would favor Benra 30 mg treatment group.|||43.47|5.79|<0.0001
73903264|NCT04543409|147336855|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.04||||0.8656|TWO_SIDED|95.0|-0.5|0.42|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Dysphagia-related pain.||0.42|-0.50|0.8656
73903265|NCT04543409|147336855|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.181||||0.3926|TWO_SIDED|95.0|-0.6|0.23|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Dysphagia-related discomfort.||0.23|-0.60|0.3926
73903266|NCT04543409|147336855|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.344||||0.0867|TWO_SIDED|95.0|-0.74|0.05|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Overall episode severity.||0.05|-0.74|0.0867
73903267|NCT04543409|147336857|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.267||||0.2248|TWO_SIDED|95.0|-0.16|0.7|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Abdominal pain severity||0.70|-0.16|0.2248
73962297|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1971|TWO_SIDED|95.0|0.85|2.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=90% reduction||2.19|0.85|0.1971
73962298|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.59||||0.048|TWO_SIDED|95.0|1.0|2.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=90% reduction||2.52|1.00|0.0480
73962299|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4744|TWO_SIDED|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=30% reduction||1.28|0.89|0.4744
73962300|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0336|TWO_SIDED|95.0|1.02|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=30% reduction||1.45|1.02|0.0336
73962301|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.2||||0.0559|TWO_SIDED|95.0|1.0|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=50% reduction||1.44|1.00|0.0559
73903268|NCT04543409|147336857|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.296||||0.1575|TWO_SIDED|95.0|-0.11|0.71|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Nausea severity.||0.71|-0.11|0.1575
73903269|NCT04543409|147336860|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.202||||0.8239|TWO_SIDED|95.0|-1.57|1.98|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Eating/Diet Impact||1.98|-1.57|0.8239
73903270|NCT04543409|147336860|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.147||||0.7623|TWO_SIDED|95.0|-0.8|1.1|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Social Impact||1.10|-0.80|0.7623
73903271|NCT04543409|147336860|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference of Least Squares Means|0.01||||0.9898|TWO_SIDED|95.0|-1.47|1.49|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Emotional Impact||1.49|-1.47|0.9898
73903272|NCT04543409|147336860|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.386||||0.4603|TWO_SIDED|95.0|-0.64|1.41|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Disease Anxiety||1.41|-0.64|0.4603
73903273|NCT04543409|147336860|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.162||||0.6613|TWO_SIDED|95.0|-0.89|0.56|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Swallowing Anxiety||0.56|-0.89|0.6613
73903274|NCT04543409|147336860|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|1.017||||0.6965|TWO_SIDED|95.0|-4.09|6.13|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Total Score||6.13|-4.09|0.6965
73903275|NCT04543409|147336862|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.3||||0.6852|TWO_SIDED|95.0|-1.93|1.27|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Physical functioning (PF)||1.27|-1.93|0.6852
73903276|NCT04543409|147336862|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.9||||0.2685|TWO_SIDED|95.0|-2.57|0.72|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Role limitations due to physical health (RP)||0.72|-2.57|0.2685
73903277|NCT04543409|147336862|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.8||||0.538|TWO_SIDED|95.0|-3.27|1.71|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Bodily pain (BP)||1.71|-3.27|0.5380
73903278|NCT04543409|147336862|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.0||||0.9734|TWO_SIDED|95.0|-1.81|1.75|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||General health perceptions (GH)||1.75|-1.81|0.9734
73903279|NCT04543409|147336862|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.0||||0.9653|TWO_SIDED|95.0|-2.09|2.19|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Vitality (VT)||2.19|-2.09|0.9653
73903280|NCT04543409|147336862|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-1.5||||0.2326|TWO_SIDED|95.0|-4.04|0.98|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Social functioning (SF)||0.98|-4.04|0.2326
73962302|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0021|TWO_SIDED|95.0|1.11|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=50% reduction||1.61|1.11|0.0021
73903281|NCT04543409|147336862|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.7||||0.6274|TWO_SIDED|95.0|-3.44|2.08|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Role limitations due to emotional problems (RE)||2.08|-3.44|0.6274
73903282|NCT04543409|147336862|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.9||||0.4599|TWO_SIDED|95.0|-3.14|1.42|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Mental health (MH)||1.42|-3.14|0.4599
73903283|NCT04543409|147336862|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.4||||0.6456|TWO_SIDED|95.0|-2.07|1.28|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Psychometrically-based physical summary score (PCS)||1.28|-2.07|0.6456
73903284|NCT04543409|147336862|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.6||||0.6206|TWO_SIDED|95.0|-3.08|1.84|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Mental health component summary scores (MCS)||1.84|-3.08|0.6206
73903285|NCT00518973|147336889|SUPERIORITY|||||||0.15||||||t = 2.8|t-test, 2 sided|Hours occupied by preoccupations.||||||.15
73903286|NCT00518973|147336889|SUPERIORITY|||||||0.4||||||t = .56|t-test, 2 sided|Hours of rituals||||||.40
73903287|NCT00518973|147336890|SUPERIORITY|||||||0.72||||||t = .13|t-test, 2 sided|||||||.72
73903288|NCT00518973|147336891|SUPERIORITY|||||||0.48||||||t = .52|t-test, 2 sided|Reporting for Trait||||||.48
73903289|NCT00518973|147336891|SUPERIORITY|||||||0.77||||||t = .09|t-test, 2 sided|Reporting for State||||||.77
73903290|NCT00518973|147336892|SUPERIORITY|||||||0.83||||||t = .05|t-test, 2 sided|||||||.83
73903291|NCT00518973|147336893|SUPERIORITY|||||||0.4||||||t = .78|t-test, 2 sided|Positive Scale||||||.40
73903292|NCT00518973|147336893|SUPERIORITY|||||||0.11||||||t=3.0|t-test, 2 sided|Negative Scale||||||.11
73962303|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0535|TWO_SIDED|95.0|1.0|1.59|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=70% reduction||1.59|1.00|0.0535
73903293|NCT00518973|147336893|SUPERIORITY|||||||0.9||||||t = .02|t-test, 2 sided|General Scale||||||.90
73903294|NCT01754909|147336900|SUPERIORITY|Occurrence rates, comparison by t test||||||0.05|||||||t-test, 2 sided|||||||0.05
73903295|NCT01923168|147336953|OTHER|Bayesian double criteria|Mean Difference (Final Values)|-1.3||||0.282|TWO_SIDED|80.0|-4.5|1.7|||Posterior mean diff. & credible interval|||||1.7|-4.5|0.282
73903296|NCT01923168|147336954|OTHER|Bayesian double criteria|Mean Difference (Final Values)|1.1||||0.697|TWO_SIDED|80.0|-1.9|4.2|||Posterior mean difference|Posterior mean difference||||4.2|-1.9|0.697
73903297|NCT01923168|147336955|OTHER|Bayesian double criteria|Mean Difference (Final Values)|-1.4||||0.435|TWO_SIDED|80.0|-12.5|9.7|||Posterior mean diff. & credible interval|||||9.7|-12.5|0.435
73903298|NCT01923168|147336956|OTHER|Bayesian double criteria|Mean Difference (Final Values)|2.4||||0.611|TWO_SIDED|80.0|-8.4|13.2|||Posterior mean diff. & credible interval|||||13.2|-8.4|0.611
73903299|NCT02313454|147336985|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|0.8||0.008|TWO_SIDED|95.0|-1.0|-0.19|||Paired t-test||Intranasal Application relative to the Extranasal Application|||-0.19|-1.0|0.008
73903300|NCT02313454|147336986|SUPERIORITY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|15.7||0.004|TWO_SIDED|95.0|-19.0|-3.4|||Paired t-test||Intranasal application relative to Extranasal application|||-3.4|-19.0|0.004
73903301|NCT02398227|147336997|SUPERIORITY|||||||0.968|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms||||||.968
73903302|NCT02398227|147336998|SUPERIORITY|||||||0.56|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms||||||.560
73903303|NCT02925793|147337009|SUPERIORITY||Mean Difference|-2.9||||0.0106|TWO_SIDED||||||SAS Proc Mixed||For each subject, change in NRS score from baseline to week 8 was calculated as Week 8 NRS value minus Baseline NRS value. Mean change in NRS score from baseline to week 8 for each group was then calculated using a Generalized Linear Mixed Model.|Both 1% and 5% groups (statistical analysis 2) produced the same estimated value (-2.9)||||0.0106
73903304|NCT02925793|147337009|SUPERIORITY||Mean Difference|-2.9||||0.0483|TWO_SIDED||||||SAS Proc Mixed||For each subject, change in NRS score from baseline to week 8 was calculated as Week 8 NRS value minus Baseline NRS value. Mean change in NRS score from baseline to week 8 for each group was then calculated using a Generalized Linear Mixed Model.|Both 1%(statistical analysis 1) and 5% groups produced the same estimated value (-2.9)||||0.0483
73962304|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0003|TWO_SIDED|95.0|1.22|1.92|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=70% reduction||1.92|1.22|0.0003
73903305|NCT01723696|147337141|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.19|TWO_SIDED|95.0|-6.1|30.3||P-value adjusted for design factors of site, gestational age at randomization and covariates of length, race, and sex of infant.|ANCOVA|||Our targeted sample size of 218 infants with successful FEFs at 3 months of age was determined to detect with 90% power, at a significance level of 0.05, increases of 15% in mean FEF75 in the vitamin C group compared to the placebo group.||30.3|-6.1|0.19
73962305|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.11||||0.6421|TWO_SIDED|95.0|0.72|1.7|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=90% reduction||1.70|0.72|0.6421
73962306|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0207|TWO_SIDED|95.0|1.07|2.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=90% reduction||2.38|1.07|0.0207
73962307|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.15||||0.1635|TWO_SIDED|95.0|0.95|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=30% reduction||1.39|0.95|0.1635
73962308|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0529|TWO_SIDED|95.0|1.0|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=30% reduction||1.47|1.00|0.0529
73962309|NCT02528188|147460954|SUPERIORITY|The two key secondary comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.15||||0.1322|TWO_SIDED|95.0|0.96|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=50% reduction||1.37|0.96|0.1322
73962310|NCT02528188|147460954|SUPERIORITY|The two key secondary comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.22||||0.0262|TWO_SIDED|95.0|1.02|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=50% reduction||1.46|1.02|0.0262
73962311|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9805|TWO_SIDED|95.0|0.83|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=70% reduction||1.22|0.83|0.9805
73962312|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0033|TWO_SIDED|95.0|1.1|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=70% reduction||1.61|1.10|0.0033
73962313|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.24||||0.159|TWO_SIDED|95.0|0.92|1.69|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=90% reduction||1.69|0.92|0.1590
73962314|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.57||||0.0024|TWO_SIDED|95.0|1.17|2.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=90% reduction||2.11|1.17|0.0024
73962315|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|95.0|0.83|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=30% reduction||1.20|0.83|0.9932
73962316|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4374|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=30% reduction||1.29|0.90|0.4374
73903306|NCT00829985|147337155|SUPERIORITY_OR_OTHER||Risk Ratio, log|1.92|||<|0.0001|TWO_SIDED|95.0|1.51|2.45|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 1.12) vs. the extract group (numerator = 2.16).|||2.45|1.51|<0.0001
73962317|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4406|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=50% reduction||1.28|0.90|0.4406
73962318|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4078|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=50% reduction||1.29|0.90|0.4078
74024701|NCT04321343|147601795|SUPERIORITY||Median Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|10.0||0.7887|TWO_SIDED|95.0|-22.31|16.97|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||16.97|-22.31|0.7887
73903307|NCT00829985|147337156|SUPERIORITY_OR_OTHER||Risk Ratio, log|1.13||||0.088|TWO_SIDED|95.0|0.98|1.32|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 0.93) vs. the extract group (numerator = 1.06).|||1.32|0.98|0.088
73903308|NCT00829985|147337157|SUPERIORITY_OR_OTHER||Treatment Effect|0.37||||0.37|TWO_SIDED|95.0|-4.89|12.99|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.7) minus change in the placebo group (0.7).|||12.99|-4.89|0.37
73903309|NCT00829985|147337158|SUPERIORITY_OR_OTHER||Treatment Effect|5.4||||0.09|TWO_SIDED|95.0|-0.77|11.51|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.0) minus change in the placebo group (-1.3).|||11.51|-0.77|0.09
73903310|NCT03324581|147337166|SUPERIORITY||Difference|0.81|||=|0.7554|TWO_SIDED|95.0|-4.3|5.92||The change from baseline in CAARS-O:SV was analyzed using a Mixed-effect Model Repeated Measures (MMRM) methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||5.92|-4.30|=0.7554
73903311|NCT03324581|147337166|SUPERIORITY||Difference|-6.61|||=|0.0101|TWO_SIDED|95.0|-11.6|-1.6||The change from baseline in CAARS-O:SV was analyzed using a MMRM methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||-1.60|-11.6|=0.0101
73903312|NCT03324581|147337166|SUPERIORITY||Difference|-7.42|||=|0.0033|TWO_SIDED|95.0|-12.3|-2.5||The change from baseline in CAARS-O:SV was analyzed using a MMRM methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||-2.50|-12.3|=0.0033
73903313|NCT04473482|147337207|SUPERIORITY|Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios|Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|||||||Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios||Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals|||
73903314|NCT04473482|147337208|SUPERIORITY||Odds Ratio (OR)|2.31|||||TWO_SIDED|95.0|||||||GEEs with robust sandwich estimators and Wald 95% CIs with conversion to Odds Ratios|||||
73903315|NCT01306877|147337209|NON_INFERIORITY_OR_EQUIVALENCE|The objective is to reject H0 at the 0.05 significance level. A one-sided 95% confidence upper limit for PC - PE will be constructed by Newcombe's generalized Wilson score method (Newcombe 1998). H0 will be rejected at the 0.05 significance level if this upper limit is \<7%.|Risk Difference (RD)|-0.314||||0.0001|ONE_SIDED|95.0||-0.18||P-value calculated from per protocol analysis set|Chi-squared|||||-0.18||0.0001
73903316|NCT01306877|147337213|SUPERIORITY_OR_OTHER|||||||0.1844|||||||Wilcoxon (Mann-Whitney)|||||||0.1844
73903317|NCT01306877|147337214|SUPERIORITY_OR_OTHER|||||||0.5647|||||||Wilcoxon (Mann-Whitney)|||||||0.5647
73903318|NCT01306877|147337215|SUPERIORITY_OR_OTHER|||||||0.9062|||||||Wilcoxon (Mann-Whitney)|||||||0.9062
73903319|NCT02376283|147337226|OTHER|A p value \< 0.05 was considered to be statistically significant.Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||Continuous variables expressed as mean ± SD (standard deviation) and categorical variables as frequencies (%).Continuous variables analysed individually using student's independent sample t-tests. Categorical variables assessed using separate Fisher's exact (Chi-square) test.||||<0.05
73903320|NCT02376283|147337226|OTHER|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001|||||||ANOVA|ANOVA F(3,36) = 12.282||STEMI- clop vs prasl vs tic||||< 0.0001
73962319|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4071|TWO_SIDED|95.0|0.89|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=70% reduction||1.31|0.89|0.4071
73962320|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0248|TWO_SIDED|95.0|1.03|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=70% reduction||1.50|1.03|0.0248
73962321|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.88||||0.3641|TWO_SIDED|95.0|0.66|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=90% reduction||1.16|0.66|0.3641
73962322|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2497|TWO_SIDED|95.0|0.89|1.53|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=90% reduction||1.53|0.89|0.2497
73962323|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8682|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=30% reduction||1.21|0.85|0.8682
74024702|NCT04321343|147601796|SUPERIORITY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|3.7||0.1166|TWO_SIDED|95.0|-13.19|1.47|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.47|-13.19|0.1166
74024703|NCT04321343|147601796|SUPERIORITY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|3.7||0.003|TWO_SIDED|95.0|-18.26|-3.8|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-3.80|-18.26|0.0030
74024704|NCT04321343|147601796|SUPERIORITY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|3.5||0.0131|TWO_SIDED|95.0|-15.79|-1.87|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-1.87|-15.79|0.0131
74024705|NCT04321343|147601797|SUPERIORITY||Mean Difference (Final Values)|-1.013|STANDARD_ERROR_OF_MEAN|1.481||0.4963|TWO_SIDED|95.0|-3.9701|1.9436|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||1.9436|-3.9701|0.4963
74024706|NCT04321343|147601797|SUPERIORITY||Mean Difference (Final Values)|-0.712|STANDARD_ERROR_OF_MEAN|1.402||0.6131|TWO_SIDED|95.0|-3.5109|2.0866|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||2.0866|-3.5109|0.6131
73853292|NCT03479541|147255183|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.005||||0.003|TWO_SIDED|95.0|-0.009|-0.002||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for EcFo condition||-0.002|-0.009|0.003
73853293|NCT03479541|147255184|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0112||||0.042|TWO_SIDED|95.0|-0.0219|-0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Average Lap Time||-0.0004|-0.0219|0.042
73853294|NCT03479541|147255184|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0111||||0.0311|TWO_SIDED|95.0|-0.0211|-0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop Average Lap Time||-0.0010|-0.0211|0.0311
73853295|NCT03479541|147255185|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00029||||0.3226|TWO_SIDED|95.0|-0.0003|0.00087||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Gait Speed||0.00087|-0.0003|0.3226
73853296|NCT03479541|147255185|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00035||||0.2218|TWO_SIDED|95.0|-0.0002|0.0009||a priori threshold p \< 0.05|Mixed Models Analysis|||Analysis for Auditory Stroop Gait Speed|The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|0.00090|-0.0002|0.2218
73853297|NCT03479541|147255186|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.161||||0.0742|TWO_SIDED|95.0|-0.0159|0.338||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task 180 Degree Turn Velocity||0.338|-0.0159|0.0742
73853298|NCT03479541|147255186|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.217||||0.0121|TWO_SIDED|95.0|0.048|0.385||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop 180 Degree Turn Velocity||0.385|0.0480|0.0121
74024707|NCT04321343|147601797|SUPERIORITY||Mean Difference (Final Values)|-1.441|STANDARD_ERROR_OF_MEAN|1.362||0.2939|TWO_SIDED|95.0|-4.1593|1.2779|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||1.2779|-4.1593|0.2939
74024708|NCT04321343|147601798|SUPERIORITY||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.211||0.7672|TWO_SIDED|95.0|-0.4845|0.3589|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.3589|-0.4845|0.7672
74024709|NCT04321343|147601798|SUPERIORITY||Mean Difference (Final Values)|-0.127|STANDARD_ERROR_OF_MEAN|0.198||0.5233|TWO_SIDED|95.0|-0.5216|0.2678|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2678|-0.5216|0.5233
74024710|NCT04321343|147601798|SUPERIORITY||Mean Difference (Final Values)|-0.279|STANDARD_ERROR_OF_MEAN|0.18||0.1263|TWO_SIDED|95.0|-0.6376|0.0805|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.0805|-0.6376|0.1263
73853299|NCT03479541|147255187|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00063||||0.8906|TWO_SIDED|95.0|-0.0084|0.00961||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Percentage of Double Support Time of Gait Cycle||0.00961|-0.0084|0.8906
73853300|NCT03479541|147255187|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.001||||0.8447|TWO_SIDED|95.0|-0.0107|0.00874||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop Percentage of Double Support Time of Gait Cycle||0.00874|-0.0107|0.8447
73853301|NCT03479541|147255188|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0003||||0.013|TWO_SIDED|95.0|-0.0005|-0.0001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Visual Weight (VS/EO)||-0.0001|-0.0005|0.013
73853302|NCT03479541|147255188|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0001||||0.78|TWO_SIDED|95.0|-0.0003|0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Vestibular Weight (SS+VS/EO)||0.0004|-0.0003|0.780
73853303|NCT03479541|147255189|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.235|||<|0.001|TWO_SIDED|95.0|-0.361|-0.11||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Time Delay (VS/EO)||-0.110|-0.361|<0.001
73853304|NCT03479541|147255189|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.142||||0.002|TWO_SIDED|95.0|-0.233|-0.052||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Time Delay (SS+VS/EO)||-0.052|-0.233|0.002
73962324|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7317|TWO_SIDED|95.0|0.81|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=30% reduction||1.16|0.81|0.7317
73962325|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6493|TWO_SIDED|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=50% reduction||1.24|0.87|0.6493
73962326|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.98||||0.7973|TWO_SIDED|95.0|0.82|1.17|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=50% reduction||1.17|0.82|0.7973
73962327|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0757|TWO_SIDED|95.0|0.98|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=70% reduction||1.45|0.98|0.0757
73962328|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0578|TWO_SIDED|95.0|0.99|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=70% reduction||1.47|0.99|0.0578
73962329|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.02||||0.901|TWO_SIDED|95.0|0.76|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=90% reduction||1.37|0.76|0.9010
73962330|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0548|TWO_SIDED|95.0|0.99|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=90% reduction||1.74|0.99|0.0548
74084880|NCT04284553|147723129|SUPERIORITY||Mean Difference (Final Values)|4.2|||||TWO_SIDED|95.0|-24.1|32.5|||||"The estimate compares having pre-commitment as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having pre-commitment in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||32.5|-24.1|
74084881|NCT04284553|147723129|SUPERIORITY||Mean Difference (Final Values)|-12.0|||||TWO_SIDED|95.0|-45.5|21.5|||||"The estimate compares having risk framing as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having risk framing in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||21.5|-45.5|
74084882|NCT00003404|147723136|OTHER||rate of occurance|0.35|||||TWO_SIDED|95.0|0.0|8.0|||||The local recurrence rate was estimated by dividing the number of recurrences by the total sample size. An exact 95% confidence interval (95% CI) for this rate was determined by binomial distribution.|||8|0|
73962331|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7331|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=30% reduction||1.23|0.86|0.7331
74084883|NCT02459418|147723146|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|164.96|||||TWO_SIDED|90.0|137.82|197.45||||||A mixed-effects analysis of variance (ANOVA) model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. Least squares (LS) means and 90% confidence intervals (CIs) for treatment differences on log-scale were obtained and back transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||197.45|137.82|
73853305|NCT03479541|147255190|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0003||||0.237|TWO_SIDED|95.0|-0.0002|0.0007||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Stiffness (VS/EO)||0.0007|-0.0002|0.237
73853306|NCT03479541|147255190|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0008||||0.002|TWO_SIDED|95.0|0.0003|0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Stiffness (SS+VS/EO)||0.001|0.0003|0.002
73853307|NCT03479541|147255191|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0001||||0.247|TWO_SIDED|95.0|-0.0001|0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Damping (VS/EO)||0.0004|-0.0001|0.247
73853308|NCT03479541|147255191|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0004||||0.008|TWO_SIDED|95.0|0.0001|0.0007||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Damping (SS+VSEO)||0.0007|0.0001|0.008
73853309|NCT03479541|147255192|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.004||||0.003|TWO_SIDED|95.0|-0.006|-0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Evoked Center of Mass (CoM) Sway (VS/EO)||-0.001|-0.006|0.003
73853310|NCT03479541|147255192|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.001||||0.004|TWO_SIDED|95.0|-0.003|-0.0005||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Evoked CoM Sway (SS+VS/EO)||-0.0005|-0.003|0.004
73903321|NCT02376283|147337226|OTHER|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(2,40) = 29.097||NSTEMI- clopidogrel vs prasugrel vs ticagrelor||||< 0.0001
73903322|NCT02376283|147337227|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SEM (Standard Error of Measurement) and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||<0.05
73903323|NCT02376283|147337227|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||=|0.123|||||||ANOVA|ANOVA F(6,56)=1.707||STEMI- different drugs (as stated above)||||=0.123
73903324|NCT02376283|147337227|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(4,62)=18.932||NSTEMI- different drugs (as stated above)||||<0.0001
73903325|NCT02376283|147337228|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||<0.05
73903326|NCT02376283|147337228|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||=|0.81||||||STEMI- clopidogrel vs prasugrel vs ticagrelor|ANOVA|ANOVA F(3,17) = 0.321||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||=0.810
73903327|NCT02376283|147337228|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.0001||||||NSTEMI- clopi vs pras vs tic|ANOVA|ANOVA F(2,25) = 14.103||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||< 0.0001
73903328|NCT01076075|147337233|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.68|||<|0.001|TWO_SIDED|95.0|-0.87|-0.5|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.||-0.50|-0.87|<0.001
73903329|NCT01076075|147337234|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-33.5|||<|0.001|TWO_SIDED|95.0|-45.3|-21.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, difference in the Least Squares Means.||-21.7|-45.3|<0.001
73962332|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.98||||0.8632|TWO_SIDED|95.0|0.82|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=30% reduction||1.18|0.82|0.8632
73962333|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6262|TWO_SIDED|95.0|0.88|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=50% reduction||1.25|0.88|0.6262
73962334|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6817|TWO_SIDED|95.0|0.81|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=50% reduction||1.15|0.81|0.6817
73853311|NCT03479541|147255193|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.004||||0.031|TWO_SIDED|95.0|-0.007|-0.0003||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Internal Sensory Noise (VS/EO)||-0.0003|-0.007|0.031
73853312|NCT03479541|147255193|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.003||||0.003|TWO_SIDED|95.0|-0.005|-0.0003||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Internal Sensory Noise (SS+VS/EO)||-0.0003|-0.005|0.003
73853313|NCT03479541|147255194|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age and gender), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0321||||0.3221|TWO_SIDED|95.0|-0.0957|0.0315||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.0315|-0.0957|0.3221
73853314|NCT03479541|147255195|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0136||||0.336|TWO_SIDED|95.0|-0.0413|0.0142||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.0142|-0.0413|0.336
73903330|NCT01076075|147337235|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-18.6|||<|0.001|TWO_SIDED|95.0|-26.4|-10.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.||-10.7|-26.4|<0.001
73903331|NCT05038904|147337249|SUPERIORITY|We estimated that 10 subjects allowed for 80% power to detect a 3-fold increase (1.1 natural log units; i.e. 1 food dose escalation) in the threshold food dose using a paired t test with p\<0.05. For this sample size determination, the primary endpoint was assumed to be normally distributed with a standard deviation of 1.1 natural log units.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73962335|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.03||||0.799|TWO_SIDED|95.0|0.85|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=70% reduction||1.24|0.85|0.7990
73853315|NCT03479541|147255196|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0406||||0.033|TWO_SIDED|95.0|-0.0779|-0.0032||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.0032|-0.0779|0.033
73853316|NCT00661726|147255197|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
73853317|NCT00661726|147255199|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.045
73853318|NCT00661726|147255200|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.083
73853319|NCT00661726|147255201|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.039
73853320|NCT00661726|147255202|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.18
73853321|NCT00661726|147255203|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
73853322|NCT00661726|147255204|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.069
73903332|NCT05038904|147337250|SUPERIORITY|||||||0.0014|||||||t-test, 2 sided|||||||0.0014
73903333|NCT05038904|147337251|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73903334|NCT05038904|147337252|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Participants' ex vivo basophil activation during acalabrutinib treatment was compared to their own baseline level.||||0.002
73903335|NCT05080660|147337267|SUPERIORITY||Posterior Mean Difference|0.23|||||TWO_SIDED|95.0|-0.26|0.73|||||Posterior mean difference with 95% credible interval is reported.|||0.73|-0.26|
74024711|NCT04321343|147601799|SUPERIORITY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.165||0.8662|TWO_SIDED|95.0|-0.3559|0.3002|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.3002|-0.3559|0.8662
74024712|NCT04321343|147601799|SUPERIORITY||Mean Difference (Final Values)|-0.094|STANDARD_ERROR_OF_MEAN|0.166||0.5726|TWO_SIDED|95.0|-0.4253|0.2369|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2369|-0.4253|0.5726
74024713|NCT04321343|147601799|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.153||0.2289|TWO_SIDED|95.0|-0.4907|0.1192|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.1192|-0.4907|0.2289
74024714|NCT04321343|147601800|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.254||0.8595|TWO_SIDED|95.0|-0.5509|0.4607|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.4607|-0.5509|0.8595
74024715|NCT04321343|147601800|SUPERIORITY||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.25||0.3776|TWO_SIDED|95.0|-0.7194|0.2759|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2759|-0.7194|0.3776
74024716|NCT04321343|147601800|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.232||0.0424|TWO_SIDED|95.0|-0.9426|0.017|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.0170|-0.9426|0.0424
74024717|NCT04321343|147601801|SUPERIORITY||Odds Ratio (OR)|3.31||||0.1084|TWO_SIDED|95.0|0.775|14.152|||Cochran-Mantel-Haenszel|||||14.152|0.775|0.1084
73903336|NCT05080660|147337268|SUPERIORITY||Posterior Mean Difference|0.19|||||TWO_SIDED|95.0|-0.39|0.76|||||Posterior mean difference with 95% credible interval is reported.|||0.76|-0.39|
74024718|NCT04321343|147601801|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0562|TWO_SIDED|95.0|0.959|17.594|||Cochran-Mantel-Haenszel|||||17.594|0.959|0.0562
74024719|NCT04321343|147601801|SUPERIORITY||Odds Ratio (OR)|1.87||||0.3333|TWO_SIDED|95.0|0.501|6.948|||Cochran-Mantel-Haenszel|||||6.948|0.501|0.3333
73903337|NCT05080660|147337269|SUPERIORITY||Posterior Mean Difference|0.62|||||TWO_SIDED|95.0|-0.23|1.47|||||Posterior mean difference with 95% credible interval is reported.|||1.47|-0.23|
73903338|NCT05080660|147337270|SUPERIORITY||Posterior Mean Difference|0.34|||||TWO_SIDED|95.0|-0.67|1.34|||||Posterior mean difference with 95% credible interval is reported.|||1.34|-0.67|
73903339|NCT05080660|147337271|SUPERIORITY||Posterior Mean Difference|0.08|||||TWO_SIDED|95.0|-0.35|0.5|||||Posterior mean difference with 95% credible interval is reported.|||0.50|-0.35|
73903340|NCT05080660|147337272|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.35|0.55|||||Posterior mean difference with 95% credible interval is reported.|||0.55|-0.35|
73903341|NCT05080660|147337273|SUPERIORITY||Posterior Mean Difference|1.98|||||TWO_SIDED|95.0|-0.88|4.88|||||Posterior mean difference with 95% credible interval is reported.|||4.88|-0.88|
73903342|NCT05080660|147337274|SUPERIORITY||Posterior Mean Difference|3.05|||||TWO_SIDED|95.0|-0.29|6.38|||||Posterior mean difference with 95% credible interval is reported.|||6.38|-0.29|
73903343|NCT05080660|147337275|SUPERIORITY||Posterior Mean Difference|0.13|||||TWO_SIDED|95.0|-0.23|0.5|||||Posterior mean difference with 95% credible interval is reported.|||0.50|-0.23|
74024720|NCT04321343|147601802|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7677|TWO_SIDED|95.0|0.345|4.23|||Cochran-Mantel-Haenszel|||||4.230|0.345|0.7677
74024721|NCT04321343|147601802|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4828|TWO_SIDED|95.0|0.434|6.012|||Cochran-Mantel-Haenszel|||||6.012|0.434|0.4828
74024722|NCT04321343|147601802|SUPERIORITY||Odds Ratio (OR)|1.97||||0.2711|TWO_SIDED|95.0|0.598|6.486|||Cochran-Mantel-Haenszel|||||6.486|0.598|0.2711
74024723|NCT04321343|147601803|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5981|TWO_SIDED|95.0|0.376|5.547|||Cochran-Mantel-Haenszel|||||5.547|0.376|0.5981
74024724|NCT04321343|147601803|SUPERIORITY||Odds Ratio (OR)|1.42||||0.6228|TWO_SIDED|95.0|0.363|5.572|||Cochran-Mantel-Haenszel|||||5.572|0.363|0.6228
74024725|NCT04321343|147601803|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8799|TWO_SIDED|95.0|0.245|3.323|||Cochran-Mantel-Haenszel|||||3.323|0.245|0.8799
74024726|NCT04321343|147601804|SUPERIORITY||Odds Ratio (OR)|3.28||||0.1474|TWO_SIDED|95.0|0.625|17.208|||Cochran-Mantel-Haenszel|||||17.208|0.625|0.1474
74024727|NCT04321343|147601804|SUPERIORITY||Odds Ratio (OR)|2.65||||0.262|TWO_SIDED|95.0|0.481|14.631|||Cochran-Mantel-Haenszel|||||14.631|0.481|0.2620
74024728|NCT04321343|147601804|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6935|TWO_SIDED|95.0|0.117|4.133|||Cochran-Mantel-Haenszel|||||4.133|0.117|0.6935
74024729|NCT04321343|147601805|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6384|TWO_SIDED|95.0|-0.35|0.215|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.215|-0.350|0.6384
74024730|NCT04321343|147601805|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.0549|TWO_SIDED|95.0|-0.547|0.006|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.006|-0.547|0.0549
74024731|NCT04321343|147601805|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.14||0.003|TWO_SIDED|95.0|-0.683|-0.142|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.142|-0.683|0.0030
74024732|NCT04321343|147601806|SUPERIORITY||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.389||0.8961|TWO_SIDED|95.0|-0.8165|0.7149|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7149|-0.8165|0.8961
73903344|NCT05080660|147337276|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.39|0.37|||||Posterior mean difference with 95% credible interval is reported.|||0.37|-0.39|
73903345|NCT05080660|147337277|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.21|0.81|||||Posterior mean difference with 95% credible interval is reported.|||0.81|-0.21|
73962336|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6786|TWO_SIDED|95.0|0.86|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=70% reduction||1.26|0.86|0.6786
73962337|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8069|TWO_SIDED|95.0|0.78|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=90% reduction||1.38|0.78|0.8069
73962338|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2951|TWO_SIDED|95.0|0.88|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=90% reduction||1.54|0.88|0.2951
73962339|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9093|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=30% reduction||1.21|0.85|0.9093
73962340|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5032|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=30% reduction||1.12|0.79|0.5032
73962341|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4382|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=50% reduction||1.28|0.90|0.4382
73962342|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.95||||0.5638|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=50% reduction||1.13|0.79|0.5638
73962343|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.05||||0.6436|TWO_SIDED|95.0|0.86|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=70% reduction||1.27|0.86|0.6436
73962344|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.04||||0.706|TWO_SIDED|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=70% reduction||1.26|0.85|0.7060
73962345|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.96||||0.7729|TWO_SIDED|95.0|0.72|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=90% reduction||1.28|0.72|0.7729
73962346|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.07||||0.6405|TWO_SIDED|95.0|0.81|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=90% reduction||1.42|0.81|0.6405
73962347|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9046|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=30% reduction||1.21|0.85|0.9046
73903346|NCT05080660|147337278|SUPERIORITY||Posterior Mean Difference|0.29|||||TWO_SIDED|95.0|-0.31|0.9|||||Posterior mean difference with 95% credible interval is reported.|||0.90|-0.31|
73962348|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.93||||0.4491|TWO_SIDED|95.0|0.78|1.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=30% reduction||1.11|0.78|0.4491
73962349|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7429|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=50% reduction||1.23|0.86|0.7429
73903347|NCT05080660|147337279|SUPERIORITY||Posterior Mean Difference|6.14|||||TWO_SIDED|95.0|-0.24|12.52|||||Posterior mean difference with 95% credible interval is reported.|||12.52|-0.24|
73903348|NCT05080660|147337280|SUPERIORITY||Posterior Mean Difference|5.15|||||TWO_SIDED|95.0|-1.9|12.18|||||Posterior mean difference with 95% credible interval is reported.|||12.18|-1.90|
73903349|NCT05080660|147337281|SUPERIORITY||Posterior Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.32|0.27|||||Posterior mean difference with 95% credible interval is reported.|||0.27|-0.32|
73903350|NCT05080660|147337282|SUPERIORITY||Posterior Mean Difference|-0.2|||||TWO_SIDED|95.0|-0.52|0.13|||||Posterior mean difference with 95% credible interval is reported.|||0.13|-0.52|
73903351|NCT05080660|147337283|SUPERIORITY||Posterior Mean Difference|98.35|||||TWO_SIDED|95.0|-51.95|250.88|||||Posterior mean difference with 95% credible interval is reported.|||250.88|-51.95|
73962350|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.92||||0.3467|TWO_SIDED|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=50% reduction||1.10|0.77|0.3467
73962351|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7624|TWO_SIDED|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=70% reduction||1.26|0.85|0.7624
73962352|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7686|TWO_SIDED|95.0|0.8|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=70% reduction||1.18|0.80|0.7686
73962353|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9384|TWO_SIDED|95.0|0.74|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=90% reduction||1.33|0.74|0.9384
73962354|NCT02528188|147460954|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8495|TWO_SIDED|95.0|0.77|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=90% reduction||1.38|0.77|0.8495
73962355|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0651|TWO_SIDED|95.0|0.99|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=30% reduction||1.44|0.99|0.0651
74024733|NCT04321343|147601806|SUPERIORITY||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.384||0.671|TWO_SIDED|95.0|-0.5935|0.9204|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.9204|-0.5935|0.6710
74024734|NCT04321343|147601806|SUPERIORITY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.364||0.9846|TWO_SIDED|95.0|-0.7092|0.7233|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7233|-0.7092|0.9846
74024735|NCT04321343|147601807|SUPERIORITY||Mean Difference (Final Values)|-84.93|STANDARD_ERROR_OF_MEAN|36.75||0.0216|TWO_SIDED|95.0|-157.306|-12.558|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-12.558|-157.306|0.0216
74024736|NCT04321343|147601807|SUPERIORITY||Mean Difference (Final Values)|-46.61|STANDARD_ERROR_OF_MEAN|35.72||0.1931|TWO_SIDED|95.0|-116.957|23.738|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||23.738|-116.957|0.1931
74024737|NCT04321343|147601807|SUPERIORITY||Mean Difference (Final Values)|-63.4|STANDARD_ERROR_OF_MEAN|33.31||0.0581|TWO_SIDED|95.0|-129.002|2.194|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.194|-129.002|0.0581
74024738|NCT04321343|147601808|SUPERIORITY||Mean Difference (Final Values)|-0.256|STANDARD_ERROR_OF_MEAN|0.153||0.0958|TWO_SIDED|95.0|-0.5577|0.0456|||Mixed Models Analysis|Mixed Models Analysis|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0456|-0.5577|0.0958
74024739|NCT04321343|147601808|SUPERIORITY||Mean Difference (Final Values)|-0.273|STANDARD_ERROR_OF_MEAN|0.148||0.0659|TWO_SIDED|95.0|-0.5648|0.0181|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0181|-0.5648|0.0659
74024740|NCT04321343|147601808|SUPERIORITY||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.138||0.0297|TWO_SIDED|95.0|-0.5728|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.0300|-0.5728|0.0297
74024741|NCT04321343|147601809|SUPERIORITY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.175||0.2606|TWO_SIDED|95.0|-0.5423|0.1476|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.1476|-0.5423|0.2606
73903352|NCT05080660|147337284|SUPERIORITY||Posterior Mean Difference|123.36|||||TWO_SIDED|95.0|-46.51|293.69|||||Posterior mean difference with 95% credible interval is reported.|||293.69|-46.51|
73903353|NCT05080660|147337285|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.06|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.06|
73903354|NCT05080660|147337286|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.07|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.07|
73903355|NCT02278341|147337301|NON_INFERIORITY|Non Inferiority, Margin = -0.75|LSM Difference|0.235|||<|0.001|TWO_SIDED|95.0|0.132|0.339||p-value for non-inferiority test based on 1-sided significance level.|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb and baseline Hb by visit as continuous variable.||0.339|0.132|<0.001
74024742|NCT04321343|147601809|SUPERIORITY||Mean Difference (Final Values)|-0.234|STANDARD_ERROR_OF_MEAN|0.17||0.1709|TWO_SIDED|95.0|-0.569|0.1016|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.1016|-0.5690|0.1709
73903356|NCT02278341|147337302|NON_INFERIORITY|Non-Inferiority, Margin = -0.75|LSM Difference|0.171|||<|0.001|TWO_SIDED|95.0|0.082|0.261||p-value for non-inferiority test based on 1-sided significance level.|ANCOVA|||The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable. Statistical analysis used was ANCOVA model with multiple imputations (MI). Missing hemoglobin data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model.||0.261|0.082|<0.001
73903357|NCT02278341|147337303|NON_INFERIORITY|Non-inferiority of roxadustat versus ESA (the non-inferiority margin for the difference between groups is -15%).|Difference of Percentages|2.3|||<|0.05|TWO_SIDED|95.0|-2.9|7.6||p-value for non-inferiority test based on 1-sided significance level.|Miettinen and Nurminen|||A generalized linear model was used to estimate the difference in response rates between the arms, as an approximation for the Miettinen and Nurminen method, adjusting for following covariates: region, previous ESA treatment, cardiovascular history and baseline Hb as categorical variables.||7.6|-2.9|<0.05
73903358|NCT02278341|147337304|SUPERIORITY||LSM Difference|-0.377|||<|0.001|TWO_SIDED|95.0|-0.451|-0.304||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline LDL, baseline Hb as continuous variables.||-0.304|-0.451|<0.001
73903359|NCT02278341|147337305|SUPERIORITY||LSM Difference|-31.9|||<|0.001|TWO_SIDED|95.0|-41.4|-22.4||p-value for superiority test based on 2-sided significance level|ANCOVA|||The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-22.4|-41.4|<0.001
73903360|NCT02278341|147337306|NON_INFERIORITY|The margin for non-inferiority was -3.|LSM Difference|0.205|||<|0.05|TWO_SIDED|95.0|-0.649|1.059||p-value for non-inferiority test based on 1-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits (week 8, week 12, week 28) and visit by treatment as categorical variables, and baseline SF-36 PF, baseline Hb as continuous variables.||1.059|-0.649|<0.05
73903361|NCT02278341|147337307|NON_INFERIORITY|The margin for non-inferiority was -3.|LSM Difference|0.856|||<|0.05|TWO_SIDED|95.0|-0.115|1.828|||Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits (week 8, week 12, week 28) and visit by treatment as categorical variables, and baseline SF-36 VT, baseline Hb as continuous variables.||1.828|-0.115|<0.05
73903362|NCT02278341|147337308|NON_INFERIORITY|The margin for non-inferiority was 1.|LSM Difference|-0.849|||<|0.05|TWO_SIDED|95.0|-1.971|0.273||p-value for non-inferiority test based on 1-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables, and baseline MAP, baseline Hb as continuous variables.||0.273|-1.971|<0.05
73903363|NCT02278341|147337309|NON_INFERIORITY|Non-inferiority (hazard ratio margin of 1.3).|Hazard Ratio (HR)|0.924|||<|0.05|TWO_SIDED|95.0|0.669|1.276||p-value for non-inferiority test based on 1-sided significance level.|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Non-inferiority was declared if the upper bound of the 95% CI is below 1.3.||1.276|0.669|<0.05
74024743|NCT04321343|147601809|SUPERIORITY||Mean Difference (Final Values)|-0.321|STANDARD_ERROR_OF_MEAN|0.155||0.04|TWO_SIDED|95.0|-0.6274|-0.0148|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.0148|-0.6274|0.0400
74024744|NCT04321343|147601810|SUPERIORITY||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.012||0.3955|TWO_SIDED|95.0|-0.0139|0.0351|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0351|-0.0139|0.3955
74024745|NCT04321343|147601810|SUPERIORITY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3081|TWO_SIDED|95.0|-0.0115|0.0362|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0362|-0.0115|0.3081
74084884|NCT02459418|147723147|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|123.15|||||TWO_SIDED|90.0|108.12|140.28||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||140.28|108.12|
73903364|NCT02278341|147337310|SUPERIORITY||LSM Difference|-0.579|||=|0.308|TWO_SIDED|95.0|-1.694|0.536||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables, and baseline MAP, baseline Hb as continuous variables.||0.536|-1.694|=0.308
73903365|NCT02278341|147337311|SUPERIORITY||Hazard Ratio (HR)|0.915|||=|0.582|TWO_SIDED|95.0|0.668|1.254||p-value for superiority test based on 2-sided significance level.|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI is lower than 1.||1.254|0.668|=0.582
74024746|NCT04321343|147601810|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.011||0.1374|TWO_SIDED|95.0|-0.0053|0.0383|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0383|-0.0053|0.1374
74024747|NCT04321343|147601811|SUPERIORITY||Mean Difference (Final Values)|-48.94|STANDARD_ERROR_OF_MEAN|20.86||0.0199|TWO_SIDED|95.0|-90.073|-7.817|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-7.817|-90.073|0.0199
74084885|NCT02459418|147723148|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-∞) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS mean ratio|133.68|||||TWO_SIDED|90.0|102.42|174.49||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||174.49|102.42|
73903366|NCT02278341|147337312|SUPERIORITY||Difference of Percentages|1.4|||=|0.609|TWO_SIDED|95.0|-3.8|6.5||p-value for superiority test based on 2-sided significance level|Miettinen and Nurminen method|||A generalized linear model was used to estimate the difference in response rates between the arms, as an approximation for the Miettinen and Nurminen method, adjusting for following covariates: region, previous ESA treatment, cardiovascular history and baseline Hb as categorical variables.||6.5|-3.8|=0.609
73903367|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.164|||<|0.001|TWO_SIDED|95.0|0.072|0.256||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 1- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.256|0.072|<0.001
73903368|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.443|||<|0.001|TWO_SIDED|95.0|0.339|0.546||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 2- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.546|0.339|<0.001
73903369|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.561|||<|0.001|TWO_SIDED|95.0|0.451|0.672||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 3 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.672|0.451|<0.001
73903370|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.708|||<|0.001||95.0|0.588|0.828||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 4 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.828|0.588|<0.001
73903371|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.768|||<|0.001|TWO_SIDED|95.0|0.645|0.89||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 5 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.890|0.645|<0.001
73903372|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.729|||<|0.001|TWO_SIDED|95.0|0.604|0.855||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 6 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.855|0.604|<0.001
73903373|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.729|||<|0.001|TWO_SIDED|95.0|0.603|0.856||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 7 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.856|0.603|<0.001
73903374|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.574|0.826||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 8 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.826|0.574|<0.001
73903375|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.659|||<|0.001|TWO_SIDED|95.0|0.53|0.788||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 10 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.788|0.530|<0.001
73903376|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.593|||<|0.001|TWO_SIDED|95.0|0.459|0.727||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 12 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.727|0.459|<0.001
73903377|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.503|||<|0.001|TWO_SIDED|95.0|0.366|0.64||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 14 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.640|0.366|<0.001
73903378|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.369|||<|0.001|TWO_SIDED|95.0|0.229|0.51||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 16 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.510|0.229|<0.001
73903379|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.363|||<|0.001|TWO_SIDED|95.0|0.23|0.496||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 18 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.496|0.230|<0.001
73962356|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9032|TWO_SIDED|95.0|0.84|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=30% reduction||1.22|0.84|0.9032
73962357|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.36||||0.01|TWO_SIDED|95.0|1.08|1.72|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=50% reduction||1.72|1.08|0.0100
73962358|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.12||||0.3728|TWO_SIDED|95.0|0.88|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=50% reduction||1.42|0.88|0.3728
73903380|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.284|||<|0.001|TWO_SIDED|95.0|0.154|0.414||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 20 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.414|0.154|<0.001
73903381|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.197|||=|0.003|TWO_SIDED|95.0|0.065|0.329||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 22 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.329|0.065|=0.003
73903382|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.187|||=|0.004|TWO_SIDED|95.0|0.059|0.316||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 24 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.316|0.059|=0.004
73903383|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.243|||<|0.001|TWO_SIDED|95.0|0.113|0.373||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 26 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.373|0.113|<0.001
73903384|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.207|||=|0.002|TWO_SIDED|95.0|0.074|0.34||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 28 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.340|0.074|=0.002
73903385|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.227|||<|0.001|TWO_SIDED|95.0|0.096|0.358||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 30 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.358|0.096|<0.001
73903386|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.199|||=|0.004|TWO_SIDED|95.0|0.064|0.334|||Mixed Models Analysis|p-value for superiority test based on 2-sided significance level.||Week 32 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.334|0.064|=0.004
73903387|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.279|||<|0.001||95.0|0.15|0.409||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 34 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.409|0.150|<0.001
73903388|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.256|||<|0.001|TWO_SIDED|95.0|0.121|0.391||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 36- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.391|0.121|<0.001
73903389|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.136|||=|0.06|TWO_SIDED|95.0|-0.006|0.277||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 40 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.277|-0.006|=0.060
73962359|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0434|TWO_SIDED|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=70% reduction||2.04|1.01|0.0434
73903390|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.082|||=|0.293|TWO_SIDED|95.0|-0.071|0.236||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 44 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.236|-0.071|=0.293
73903391|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.027|||=|0.723|TWO_SIDED|95.0|-0.123|0.177||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 48 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.177|-0.123|=0.723
73962360|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0425|TWO_SIDED|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=70% reduction||2.04|1.01|0.0425
73903392|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.199|||=|0.009|TWO_SIDED|95.0|0.049|0.348||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 52 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.348|0.049|=0.009
73903393|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.147|||=|0.056|TWO_SIDED|95.0|-0.004|0.298||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 56 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.298|-0.004|=0.056
73903394|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.196|||=|0.01|TWO_SIDED|95.0|0.047|0.346||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 60 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.346|0.047|=0.010
73903395|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.275|||<|0.001|TWO_SIDED|95.0|0.123|0.427||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 64 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.427|0.123|<0.001
73903396|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.206|||=|0.006|TWO_SIDED|95.0|0.059|0.353||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 68 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.353|0.059|=0.006
73903397|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.118|||=|0.127|TWO_SIDED|95.0|-0.033|0.269||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 72 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.269|-0.033|=0.127
73903398|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.211|||=|0.01|TWO_SIDED|95.0|0.051|0.371||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 76 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.371|0.051|=0.010
73903399|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.102|||=|0.191|TWO_SIDED|95.0|-0.051|0.255||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 80 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.255|-0.051|=0.191
73903400|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.192|||=|0.018|TWO_SIDED|95.0|0.033|0.351||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 84 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.351|0.033|=0.018
73903401|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.044|||=|0.576|TWO_SIDED|95.0|-0.111|0.2||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 88 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.200|-0.111|=0.576
73962361|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5442|TWO_SIDED|95.0|0.64|2.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=90% reduction||2.34|0.64|0.5442
73962362|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0349|TWO_SIDED|95.0|1.05|3.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=90% reduction||3.45|1.05|0.0349
73962363|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0108|TWO_SIDED|95.0|1.05|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=30% reduction||1.51|1.05|0.0108
73962364|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.27||||0.008|TWO_SIDED|95.0|1.07|1.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=30% reduction||1.52|1.07|0.0080
73903402|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.203|||=|0.017|TWO_SIDED|95.0|0.037|0.369||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 92 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.369|0.037|=0.017
73903403|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.184|||=|0.019|TWO_SIDED|95.0|0.031|0.338||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 96 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.338|0.031|=0.019
73962365|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.5|||<|0.0001|TWO_SIDED|95.0|1.22|1.83|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=50% reduction||1.83|1.22|<0.0001
73962366|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.51|||<|0.0001|TWO_SIDED|95.0|1.24|1.85|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=50% reduction||1.85|1.24|<0.0001
73962367|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.45||||0.006|TWO_SIDED|95.0|1.11|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=70% reduction||1.88|1.11|0.0060
74024748|NCT04321343|147601811|SUPERIORITY||Mean Difference (Final Values)|-29.77|STANDARD_ERROR_OF_MEAN|18.66||0.112|TWO_SIDED|95.0|-66.558|7.009|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.009|-66.558|0.1120
74024749|NCT04321343|147601811|SUPERIORITY||Mean Difference (Final Values)|-54.64|STANDARD_ERROR_OF_MEAN|17.9||0.0026|TWO_SIDED|95.0|-89.935|-19.34|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-19.340|-89.935|0.0026
73903404|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.164|||=|0.056||95.0|-0.004|0.333||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 100 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.333|-0.004|=0.056
73903405|NCT02278341|147337313|SUPERIORITY||LSM Difference|0.099|||=|0.267|TWO_SIDED|95.0|-0.076|0.273||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 104 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.273|-0.076|=0.267
73903406|NCT02278341|147337314|SUPERIORITY||LSM Difference|0.237|||<|0.001|TWO_SIDED|95.0|0.127|0.347||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Weeks 28-36 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.347|0.127|<0.001
73903407|NCT02278341|147337314|SUPERIORITY||LSM Difference|0.105|||=|0.086|TWO_SIDED|95.0|-0.015|0.225||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||Weeks 44-52 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.225|-0.015|=0.086
73903408|NCT02278341|147337314|SUPERIORITY||LSM Difference|0.149|||=|0.031|TWO_SIDED|95.0|0.014|0.284||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||Weeks 96-104 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.284|0.014|=0.031
73962368|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0031|TWO_SIDED|95.0|1.14|1.93|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=70% reduction||1.93|1.14|0.0031
73962369|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0235|TWO_SIDED|95.0|1.08|2.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=90% reduction||2.88|1.08|0.0235
73962370|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0021|TWO_SIDED|95.0|1.31|3.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=90% reduction||3.42|1.31|0.0021
73962371|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7613|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=30% reduction||1.23|0.86|0.7613
73962372|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0548|TWO_SIDED|95.0|1.0|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=30% reduction||1.43|1.00|0.0548
74024750|NCT04321343|147601812|SUPERIORITY||Mean Difference (Final Values)|1.674|STANDARD_ERROR_OF_MEAN|0.896||0.0639|TWO_SIDED|95.0|-0.098|3.447|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||3.4470|-0.0980|0.0639
73853323|NCT00661726|147255205|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.18
73853324|NCT00661726|147255206|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.022
73853325|NCT00661726|147255207|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.11
73903409|NCT02278341|147337315|SUPERIORITY||LSM Difference|0.235|||<|0.001|TWO_SIDED|95.0|0.125|0.346|||Mixed Models Analysis|||Weeks 28-36 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.346|0.125|<0.001
73903410|NCT02278341|147337315|SUPERIORITY||LSM Difference|0.104|||=|0.11|TWO_SIDED|95.0|-0.024|0.232|||Mixed Models Analysis|||Weeks 44-52 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.232|-0.024|=0.110
73903411|NCT02278341|147337315|SUPERIORITY||LSM Difference|0.149|||=|0.036|TWO_SIDED|95.0|0.01|0.288|||Mixed Models Analysis|||Weeks 96-104 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.288|0.010|=0.036
73903412|NCT02278341|147337320|SUPERIORITY||Hazard Ratio (HR)|1.154|||=|0.164|TWO_SIDED|95.0|0.943|1.411||p-value for superiority test based on 2-sided significance level|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.411|0.943|=0.164
73903413|NCT02278341|147337321|SUPERIORITY||Hazard Ratio (HR)|0.979|||=|0.917|TWO_SIDED|95.0|0.656|1.462|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.462|0.656|=0.917
74024751|NCT04321343|147601812|SUPERIORITY||Mean Difference (Final Values)|2.831|STANDARD_ERROR_OF_MEAN|0.867||0.0014|TWO_SIDED|95.0|1.1149|4.5464|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||4.5464|1.1149|0.0014
74024752|NCT04321343|147601812|SUPERIORITY||Mean Difference (Final Values)|4.876|STANDARD_ERROR_OF_MEAN|0.848|<|0.0001|TWO_SIDED|95.0|3.1982|6.5543|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||6.5543|3.1982|<0.0001
74024753|NCT04321343|147601813|SUPERIORITY||Mean Difference (Final Values)|1.183|STANDARD_ERROR_OF_MEAN|0.909||0.1944|TWO_SIDED|95.0|-0.608|2.9748|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.9748|-0.6080|0.1944
73903414|NCT02278341|147337322|SUPERIORITY||Hazard Ratio (HR)|0.867|||=|0.501|TWO_SIDED|95.0|0.573|1.313||p-value for superiority test based on 2-sided significance level|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.313|0.573|=0.501
73903415|NCT02278341|147337323|SUPERIORITY||LSM Difference|-0.006|||=|0.507|TWO_SIDED|95.0|-0.02|0.01||p-value for superiority test based on 2-sided significance level|ANCOVA|||The model included treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||0.01|-0.02|=0.507
73903416|NCT02278341|147337324|SUPERIORITY||LSM Difference|0.132|||=|0.949|TWO_SIDED|95.0|-3.9|4.16|||ANCOVA|||The model included treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||4.16|-3.90|=0.949
73903417|NCT02278341|147337325|SUPERIORITY||Hazard Ratio (HR)|0.368|||<|0.001|TWO_SIDED|95.0|0.291|0.465|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||0.465|0.291|<0.001
73903418|NCT02278341|147337326|SUPERIORITY||LSM Difference|-35.1|||<|0.001|TWO_SIDED|95.0|-51.8|-18.4|||ANCOVA|||Weeks 37-52 - Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-18.4|-51.8|<0.001
73903419|NCT02278341|147337326|SUPERIORITY||LSM Difference|-48.7|||<|0.001|TWO_SIDED|95.0|-70.3|-27.0|||ANCOVA|||Weeks 53-104 - Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-27.0|-70.3|<0.001
74024754|NCT04321343|147601813|SUPERIORITY||Mean Difference (Final Values)|2.459|STANDARD_ERROR_OF_MEAN|0.879||0.0056|TWO_SIDED|95.0|0.7268|4.1907|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||4.1907|0.7268|0.0056
74024755|NCT04321343|147601813|SUPERIORITY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.858||0.4288|TWO_SIDED|95.0|-1.0111|2.372|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.3720|-1.0111|0.4288
73903420|NCT02278341|147337336|SUPERIORITY||LSM Difference|0.521|||=|0.161|TWO_SIDED|95.0|-0.208|1.25||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline SF-36 PCS, baseline Hb, as continuous covariates.||1.250|-0.208|=0.161
74084886|NCT02459418|147723149|OTHER||Median Difference (Net)|7.5|||||TWO_SIDED|90.0|4.5|11.5||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median differences and corresponding 90% CIs were calculated using an exact Hodges-Lehmann estimate.||11.5|4.5|
73903421|NCT02278341|147337337|SUPERIORITY||LSM Difference|0.126|||=|0.845|TWO_SIDED|95.0|-1.135|1.387||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, as continuous covariates.||1.387|-1.135|=0.845
73903422|NCT02278341|147337338|SUPERIORITY||LSM Difference|-0.128|||=|0.922|TWO_SIDED|95.0|-2.703|2.447||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, as continuous covariates.||2.447|-2.703|=0.922
74024756|NCT04321343|147601814|SUPERIORITY||Mean Difference (Final Values)|-1.251|STANDARD_ERROR_OF_MEAN|1.093||0.2564|TWO_SIDED|95.0|-3.4307|0.9295|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.9295|-3.4307|0.2564
74024757|NCT04321343|147601814|SUPERIORITY||Mean Difference (Final Values)|-1.598|STANDARD_ERROR_OF_MEAN|1.021||0.1222|TWO_SIDED|95.0|-3.6348|0.4392|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.4392|-3.6348|0.1222
74024758|NCT04321343|147601814|SUPERIORITY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.936||0.0206|TWO_SIDED|95.0|-4.088|-0.351|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||-0.3510|-4.0880|0.0206
74024759|NCT04321343|147601815|SUPERIORITY||Odds Ratio (OR)|1.51||||0.5221|TWO_SIDED|95.0|0.436|5.201|||Cochran-Mantel-Haenszel|||||5.201|0.436|0.5221
74024760|NCT04321343|147601815|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4828|TWO_SIDED|95.0|0.434|6.012|||Cochran-Mantel-Haenszel|||||6.012|0.434|0.4828
74024761|NCT04321343|147601815|SUPERIORITY||Odds Ratio (OR)|2.87||||0.0914|TWO_SIDED|95.0|0.853|9.636|||Cochran-Mantel-Haenszel|||||9.636|0.853|0.0914
74084887|NCT02459418|147723151|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|163.0|||||TWO_SIDED|90.0|94.0|282.67||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||282.67|94|
73853326|NCT00661726|147255208|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
73903423|NCT04902326|147337346|SUPERIORITY|||||||0.78|||||||Regression, Linear|||Compare the mean decrease of HbA1c of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.78
73903424|NCT04902326|147337347|SUPERIORITY|||||||0.64|||||||Regression, Linear|||Compare the mean decrease of HbA1c of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.64
73903425|NCT04902326|147337348|SUPERIORITY|||||||0.87|||||||Regression, Linear|||Compare the mean decrease of weight of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.87
73903426|NCT04902326|147337349|SUPERIORITY|||||||0.87|||||||Regression, Linear|||Compare the mean decrease of weight of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.87
73903427|NCT04902326|147337350|SUPERIORITY||||||<|0.0001|||||||Regression, Linear|||Compare the mean months engaged (with DPP or metformin) of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||<0.0001
73903428|NCT02604017|147337351|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 12-week treatment group as compared with the historical rate was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 91% to achieve noninferiority.|Percentage of Participants|99.7|||||TWO_SIDED|95.0|99.1|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥97% in the 12-week arm, 270 participants provides \>90% power to demonstrate noninferiority of the 12-week arm to the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegIFN/RBV (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|99.1|
73962373|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0196|TWO_SIDED|95.0|1.04|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=50% reduction||1.51|1.04|0.0196
73962374|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.45|||<|0.0001|TWO_SIDED|95.0|1.2|1.75|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=50% reduction||1.75|1.20|<0.0001
73853327|NCT00107900|147255215|SUPERIORITY_OR_OTHER|||||||0.238|TWO_SIDED||||||Fisher Exact|||||||0.238
73853328|NCT02374060|147255219|SUPERIORITY||Ratio of the proportion of BL|0.79|||<|0.0001|TWO_SIDED|99.87|0.65|0.96||Two sided type I error threshold was 0.00132 since recruitment was halted after the single pre-planned interim analysis|mixed effects model||Ratio of intravitreal over periocular|||.96|.65|<0.0001
73853329|NCT02374060|147255219|SUPERIORITY||Ratio of the proportion of BL|0.69|||<|0.0001|TWO_SIDED|99.87|0.56|0.86||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular|||0.86|0.56|<0.0001
73853330|NCT02374060|147255219|NON_INFERIORITY|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.88|||||TWO_SIDED|99.87|0.71|1.08|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal|||1.08|.71|
73853331|NCT02374060|147255220|SUPERIORITY||Ratio of the proportion of BL|0.95||||0.35|TWO_SIDED|99.87|0.77|1.16||Two sided type I error threshold was 0.00132 since recruitment was halted after the single Two sided type I error threshold was 0.00132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||Ratio of intravitreal over periocular|||1.16|0.77|0.35
73853332|NCT02374060|147255220|SUPERIORITY||Ratio of the proportion of BL|0.89||||0.07|TWO_SIDED|99.87|0.72|1.1||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular|||1.10|0.72|0.07
73853333|NCT02374060|147255220|NON_INFERIORITY|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.94|||||TWO_SIDED|99.87|0.77|1.16|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal|||1.16|0.77|
73853334|NCT02374060|147255221|SUPERIORITY||Difference in proportion|0.39|||<|0.0001|TWO_SIDED|95.0|0.24|0.53|||mixed effects model||Intravitreal - periocular|||0.53|0.24|<0.0001
73853335|NCT02374060|147255221|SUPERIORITY||Difference in proportion|0.44|||<|0.0001|TWO_SIDED|95.0|0.29|0.59|||mixed effects model||Dexamethasone - periocular|||0.59|0.29|<0.0001
73853336|NCT02374060|147255221|SUPERIORITY||Difference in proportion|0.05||||0.45|TWO_SIDED|95.0|-0.09|0.19|||mixed effects model||Dexamethasone - intravitreal|||0.19|-0.09|0.45
73853337|NCT02374060|147255222|SUPERIORITY||Difference in proportion|0.12||||0.1|TWO_SIDED|95.0|-0.03|0.27|||mixed effects model||Intravitreal - Periocular|||0.27|-0.03|0.10
73853338|NCT02374060|147255222|SUPERIORITY||Difference in proportion|0.12||||0.11|TWO_SIDED|95.0|-0.03|0.28|||mixed effects model||Dexamethasone - Periocular|||0.28|-0.03|0.11
73853339|NCT02374060|147255222|SUPERIORITY||Difference in proportion|0.002||||0.98|TWO_SIDED|95.0|-0.16|0.16|||mixed effects model||Dexamethasone - Intravitreal|||0.16|-0.16|0.98
73853340|NCT02374060|147255223|SUPERIORITY||Difference in proportion|0.27||||0.0005|TWO_SIDED|95.0|0.11|0.43|||mixed effects model||Intravitreal - periocular|||0.43|0.11|0.0005
73853341|NCT02374060|147255223|SUPERIORITY||Difference in proportion|0.4|||<|0.0001|TWO_SIDED|95.0|0.25|0.56|||mixed effects model||Dexamethasone - periocular|||0.56|0.25|<0.0001
73853342|NCT02374060|147255223|SUPERIORITY||Difference in proportion|0.13||||0.12|TWO_SIDED|95.0|-0.04|0.3|||mixed effects model||Dexamethasone - intravitreal|||0.30|-0.04|0.12
73853343|NCT02374060|147255224|SUPERIORITY||Difference in proportion|0.004||||0.96|TWO_SIDED|95.0|-0.16|0.17|||mixed effects model||Intravitreal - periocular|||0.17|-0.16|0.96
73853344|NCT02374060|147255224|SUPERIORITY||Difference in proportion|0.06||||0.51|TWO_SIDED|95.0|-0.11|0.23|||mixed effects model||Dexamethasone - periocular|||0.23|-0.11|0.51
73903429|NCT02604017|147337352|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 (8-week group minus 12-week group) must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Based on a 2-sided significance level of 0.05 and an -5% noninferiority margin and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides \>90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.||1.1|-1.1|
73903430|NCT02604017|147337353|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|-0.6|||||TWO_SIDED|95.0|-1.8|0.6||||||Based on a 2-sided significance level of 0.05 and a -5% noninferiority margin, and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides \>90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.||0.6|-1.8|
73903431|NCT01117051|147337363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||95.0|||||Cochran-Mantel-Haenszel|||||||0.305
73903432|NCT00366340|147337366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.5|2.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.6|-2.5|
73903433|NCT00366340|147337366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-9.6|||||TWO_SIDED|95.0|-16.0|-3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-3.3|-16.0|
73903434|NCT00366340|147337366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|2.2|||||TWO_SIDED|95.0|-0.4|5.2||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||5.2|-0.4|
73903435|NCT00366340|147337366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|1.5|||||TWO_SIDED|95.0|-0.9|4.1||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.1|-0.9|
73903436|NCT00366340|147337366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.4|||||TWO_SIDED|95.0|-4.2|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-4.2|
73903437|NCT00366340|147337366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.3|||||TWO_SIDED|95.0|-3.8|3.3||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.3|-3.8|
73903438|NCT00366340|147337366|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8|||||TWO_SIDED|95.0|-6.0|4.5||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.5|-6.0|
73903439|NCT00366340|147337367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.84||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.84|0.63|
73903440|NCT00366340|147337367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.65|||||TWO_SIDED|95.0|0.52|0.82||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||0.82|0.52|
73903441|NCT00366340|147337367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.74|
73903442|NCT00366340|147337367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.9|||||TWO_SIDED|95.0|0.76|1.07||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.76|
73903443|NCT00366340|147337367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|2.25|||||TWO_SIDED|95.0|2.04|2.49||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||2.49|2.04|
73903444|NCT00366340|147337367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.71||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||0.71|0.51|
73903445|NCT00366340|147337367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||1.06|0.73|
73903446|NCT00366340|147337370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.6|||||TWO_SIDED|95.0|-3.0|8.3||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||8.3|-3.0|
74024762|NCT04321343|147601816|SUPERIORITY||Odds Ratio (OR)|2.71||||0.1854|TWO_SIDED|95.0|0.628|11.679|||Cochran-Mantel-Haenszel|||||11.679|0.628|0.1854
73903447|NCT00366340|147337370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|4.5|||||TWO_SIDED|95.0|-4.1|13.0||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||13.0|-4.1|
73903448|NCT00366340|147337370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.5||||||For diphtheria toxoid the difference in percentages between the two groups(13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.5|-1.4|
73903449|NCT00366340|147337370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.5||||||95.0|-9.3|0.3||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||0.3|-9.3|
73962375|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0077||95.0|1.09|1.77|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=70% reduction||1.77|1.09|0.0077
73962376|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.0001|TWO_SIDED|95.0|1.3|2.09|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=70% reduction||2.09|1.30|<0.0001
73962377|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.31||||0.1942|TWO_SIDED|95.0|0.87|1.96|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=90% reduction||1.96|0.87|0.1942
73962378|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0122|TWO_SIDED|95.0|1.11|2.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=90% reduction||2.43|1.11|0.0122
73962379|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.18||||0.0977|TWO_SIDED|95.0|0.97|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=30% reduction||1.43|0.97|0.0977
73903450|NCT00366340|147337370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Haemophilus Influenzae Type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||1.5|-1.5|
74088277|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|4.43||0.3869|TWO_SIDED|95.0|-12.66|4.96|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.96|-12.66|0.3869
73903451|NCT00366340|147337370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.3||||||95.0|-5.0|2.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated||2.3|-5.0|
73903452|NCT00366340|147337370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.7|||||TWO_SIDED|95.0|-0.4|4.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||4.4|-0.4|
73903453|NCT00366340|147337370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.4|-1.4|
73903454|NCT00366340|147337370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||1.4|-1.4|
73903455|NCT00366340|147337370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.8||||||95.0|-1.3|3.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated||3.3|-1.3|
73962380|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0806|TWO_SIDED|95.0|0.98|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=30% reduction||1.44|0.98|0.0806
73962381|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.12||||0.2097|TWO_SIDED|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=50% reduction||1.34|0.94|0.2097
74088278|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-2.11|STANDARD_ERROR_OF_MEAN|4.62||0.6485|TWO_SIDED|95.0|-11.31|7.08|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||7.08|-11.31|0.6485
73903456|NCT00366340|147337371|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.23|||||TWO_SIDED|95.0|0.96|1.58||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.58|0.96|
73903457|NCT00366340|147337371|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.15|||||TWO_SIDED|95.0|0.95|1.39||||||For Haemophilus influenzae type b µg/mL the GMC ratio (13vPnC/7vPnC) was calculated||1.39|0.95|
73903458|NCT00366340|147337372|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.80|0.57|
73903459|NCT00366340|147337372|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87|||||TWO_SIDED|95.0|0.75|1.01||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.01|0.75|
73903460|NCT00366340|147337373|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.11||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated.||1.11|0.69|
73903461|NCT00366340|147337373|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.93|||||TWO_SIDED|95.0|0.71|1.22||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated||1.22|0.71|
73903462|NCT01315236|147337381|SUPERIORITY|||||||0.072||||||Conducted in the mITT population using a stratified Wilcoxon rank sum test, to compare the treatment arms at a 2-sided significance level of 0.05, adjusting for the randomization strata (presence/absence of CF and MAC versus Mycobacterium abscessus).|Wilcoxon rank sum test|||"The primary efficacy analysis tested the following hypotheses:~* H0: There is no difference at Day 84 between the LAI arm and the placebo arm~* Ha: There is a difference at Day 84 between the LAI arm and the placebo arm~Statistical analysis applies to all day 84 rows."||||0.072
73903463|NCT01315236|147337382|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||stratified Cochran-Mantel-Haenszel test||||0.003
73903464|NCT01315236|147337383|SUPERIORITY||Cox Proportional Hazard|5.68||||0.0129|TWO_SIDED|95.0|1.25|25.79|||Regression, Cox|||Cox proportional hazard model||25.79|1.25|0.0129
73903465|NCT01315236|147337384|SUPERIORITY|||||||0.077|||||||Regression, Logistic|||Ordinal Logistic Regressions Model||||0.077
73903466|NCT01315236|147337385|SUPERIORITY|||||||0.4545|||||||Wilcoxon (Mann-Whitney)|||Stratified Wilcoxon-rank sum||||0.4545
73903467|NCT01315236|147337387|SUPERIORITY||Cox Proportional Hazard|2.69||||0.0076|TWO_SIDED|95.0|1.28|5.64|||Regression, Cox|||Cox Proportional Hazard Model||5.64|1.28|0.0076
73903468|NCT02821910|147337426|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.7|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|92.89|100.66|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.66|92.89|
73903469|NCT02821910|147337426|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.8|STANDARD_DEVIATION|4.8|||TWO_SIDED|90.0|97.99|103.7|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.70|97.99|
73903470|NCT02821910|147337426|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|99.83|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|95.96|103.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.85|95.96|
73903471|NCT02821910|147337427|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.82|STANDARD_DEVIATION|9.7|||TWO_SIDED|90.0|90.65|103.42|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.42|90.65|
73903472|NCT02821910|147337427|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.67|STANDARD_DEVIATION|15.5|||TWO_SIDED|90.0|87.44|104.68|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.68|87.44|
74024763|NCT04321343|147601816|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0562|TWO_SIDED|95.0|0.959|17.594|||Cochran-Mantel-Haenszel|||||17.594|0.959|0.0562
74024764|NCT04321343|147601816|SUPERIORITY||Odds Ratio (OR)|1.53||||0.5223|TWO_SIDED|95.0|0.398|5.88|||Cochran-Mantel-Haenszel|||||5.880|0.398|0.5223
74024765|NCT04321343|147601817|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.891||0.7532|TWO_SIDED|95.0|-1.4749|2.0356|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.0356|-1.4749|0.7532
74024766|NCT04321343|147601817|SUPERIORITY||Mean Difference (Final Values)|1.985|STANDARD_ERROR_OF_MEAN|0.858||0.0216|TWO_SIDED|95.0|0.2946|3.6763|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||3.6763|0.2946|0.0216
74024767|NCT04321343|147601817|SUPERIORITY||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.838||0.7893|TWO_SIDED|95.0|-1.4283|1.8771|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.8771|-1.4283|0.7893
73962382|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0135|TWO_SIDED|95.0|1.05|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=50% reduction||1.49|1.05|0.0135
73962383|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.1||||0.3571|TWO_SIDED|95.0|0.9|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=70% reduction||1.33|0.90|0.3571
73962384|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0025|TWO_SIDED|95.0|1.11|1.63|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=70% reduction||1.63|1.11|0.0025
73962385|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4658|TWO_SIDED|95.0|0.83|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=90% reduction||1.49|0.83|0.4658
73962386|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0108|TWO_SIDED|95.0|1.09|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=90% reduction||1.90|1.09|0.0108
73962387|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8393|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=30% reduction||1.22|0.85|0.8393
73962388|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.1||||0.2977|TWO_SIDED|95.0|0.92|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=30% reduction||1.32|0.92|0.2977
73962389|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.12||||0.1944|TWO_SIDED|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=50% reduction||1.34|0.94|0.1944
73962390|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5714|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=50% reduction||1.26|0.88|0.5714
73962391|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.12||||0.2472|TWO_SIDED|95.0|0.92|1.36|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=70% reduction||1.36|0.92|0.2472
74024768|NCT03430310|147601818|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
74024769|NCT02770807|147601847|SUPERIORITY||Least squares mean difference|-1.37||||0.0847|TWO_SIDED|95.0|-2.932|0.19|||Mixed model for repeated measures|||Least squares means, and p-values are derived from a mixed model repeated measures analysis with baseline modified ICARS value as covariate and the fixed effects of treatment, age, sex, region and visit and the interaction term treatment-by-visit.||0.190|-2.932|0.0847
74024770|NCT02770807|147601847|SUPERIORITY||Least squares mean difference|-1.4||||0.0765|TWO_SIDED|95.0|-2.957|0.152|||Mixed model for repeated measures|||Least squares means, and p-values are derived from a mixed model repeated measures analysis with baseline modified ICARS value as covariate and the fixed effects of treatment, age, sex, region and visit and the interaction term treatment-by-visit.||0.152|-2.957|0.0765
74084888|NCT02459418|147723152|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|177.17|||||TWO_SIDED|90.0|125.65|249.81||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||249.81|125.65|
74024771|NCT02770807|147601848|SUPERIORITY||Odds Ratio (OR)|0.946||||0.8919|TWO_SIDED|95.0|0.426|2.099|||Regression, Logistic|||Logistic regression modeling (0/1), where 0 = No change or worsening and 1= improvement, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region as fixed effects.||2.099|0.426|0.8919
74024772|NCT02770807|147601848|SUPERIORITY||Odds Ratio (OR)|1.848||||0.1255|TWO_SIDED|95.0|0.842|4.053|||Regression, Logistic|||"Logistic regression modeling (0/1), where 0 = No change or worsening and 1= improvement, with age (at 2 levels:~\<10 years, ≥10 years), sex, treatment, region as fixed effects."||4.053|0.842|0.1255
73903473|NCT02821910|147337427|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|98.47|STANDARD_DEVIATION|9.9|||TWO_SIDED|90.0|92.12|105.25|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.25|92.12|
73903474|NCT02821910|147337428|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|94.94|STANDARD_DEVIATION|13.8|||TWO_SIDED|90.0|86.6|104.08|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.08|86.60|
73903475|NCT02821910|147337428|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|106.63|STANDARD_DEVIATION|9.9|||TWO_SIDED|90.0|100.65|112.96|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.96|100.65|
73903476|NCT02821910|147337428|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.41|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|94.54|106.64|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.64|94.54|
73903477|NCT02821910|147337429|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|97.97|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|91.46|104.94|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.94|91.46|
73903478|NCT02821910|147337429|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.04|STANDARD_DEVIATION|17.9|||TWO_SIDED|90.0|90.23|110.91|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.91|90.23|
73903479|NCT02821910|147337429|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|101.24|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|94.58|108.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||108.38|94.58|
73903480|NCT02821910|147337430|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|97.5|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|89.94|105.71|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.71|89.94|
73903481|NCT02821910|147337430|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|117.31|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|103.41|133.07|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||133.07|103.41|
73903482|NCT02821910|147337430|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|102.74|STANDARD_DEVIATION|6.2|||TWO_SIDED|90.0|98.56|107.1|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||107.10|98.56|
73962392|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0235|TWO_SIDED|95.0|1.03|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=70% reduction||1.51|1.03|0.0235
73903483|NCT02821910|147337431|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.34|STANDARD_DEVIATION|6.6|||TWO_SIDED|90.0|92.13|100.75|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.75|92.13|
73903484|NCT02821910|147337431|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|105.07|STANDARD_DEVIATION|8.6|||TWO_SIDED|90.0|99.95|110.45|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.45|99.95|
73903485|NCT02821910|147337431|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.31|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|96.41|104.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.38|96.41|
73903486|NCT02821910|147337432|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.63|STANDARD_DEVIATION|5.8|||TWO_SIDED|90.0|92.86|100.54|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.54|92.86|
73903487|NCT02821910|147337432|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.87|STANDARD_DEVIATION|5.0|||TWO_SIDED|90.0|97.96|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.86|97.96|
73903488|NCT02821910|147337432|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|99.75|STANDARD_DEVIATION|6.0|||TWO_SIDED|90.0|95.81|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.86|95.81|
73903489|NCT02821910|147337433|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.57|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|90.94|102.56|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.56|90.94|
73903490|NCT02821910|147337433|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.4|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|87.5|104.01|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.01|87.50|
73903491|NCT02821910|147337433|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|98.45|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|92.44|104.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.85|92.44|
73903492|NCT02821910|147337434|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.08|STANDARD_DEVIATION|12.6|||TWO_SIDED|90.0|87.36|103.48|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.48|87.36|
73903493|NCT02821910|147337434|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|105.72|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|98.78|113.15|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||113.15|98.78|
73903494|NCT02821910|147337434|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|101.61|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|92.0|112.22|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.22|92.00|
73903495|NCT01289782|147337435|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|29.3|||<|0.001|TWO_SIDED|95.0|20.1|38.6|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.||38.6|20.1|<0.001
73903496|NCT01289782|147337436|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|28.9|||<|0.001|TWO_SIDED|95.0|19.6|38.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVRW72 between the treatment groups.||38.2|19.6|<0.001
73903497|NCT01289782|147337437|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|30.1|||<|0.001|TWO_SIDED|95.0|20.8|39.3|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||39.3|20.8|<0.001
73903498|NCT01289782|147337438|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|25.8|||<|0.001|TWO_SIDED|95.0|16.8|34.8|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR4 between the treatment groups.||34.8|16.8|<0.001
73903499|NCT01289782|147337465|SUPERIORITY_OR_OTHER||Mean differences|-20.679|STANDARD_ERROR_OF_MEAN|6.0979|<|0.001|TWO_SIDED|95.0|-32.6399|-8.7181|||Piecewise-Linear Model Approach|||Fatigue Severity Score AUC60||-8.7181|-32.6399|<0.001
73903500|NCT01289782|147337465|SUPERIORITY_OR_OTHER||Mean differences|-23.8|STANDARD_ERROR_OF_MEAN|7.2358|<|0.001|TWO_SIDED|95.0|-37.9931|-9.6064|||Piecewise Linear Model|||Fatigue Severity Score AUC72||-9.6064|-37.9931|<0.001
73903501|NCT01289782|147337466|SUPERIORITY_OR_OTHER||Mean differences|-230.464|STANDARD_ERROR_OF_MEAN|105.9203||0.03|TWO_SIDED|95.0|-438.2662|-22.6626|||Piecewise Linear Model|||Impairment in Work Productivity AUC60||-22.6626|-438.2662|0.030
73903502|NCT01289782|147337466|SUPERIORITY_OR_OTHER||Mean differences|-248.208|STANDARD_ERROR_OF_MEAN|124.6753||0.047|TWO_SIDED|95.0|-492.8253|-3.5916|||Piecewise Linear Model|||Impairment in Work Productivity AUC72||-3.5916|-492.8253|0.047
73903503|NCT01289782|147337467|SUPERIORITY_OR_OTHER||Mean Differences|-278.06|STANDARD_ERROR_OF_MEAN|105.6088||0.009|TWO_SIDED|95.0|-485.2529|-70.8668|||Piecewise linear model|||Impairment in Daily Activities AUC60||-70.8668|-485.2529|0.009
73903504|NCT01289782|147337467|SUPERIORITY_OR_OTHER||Mean differences|-307.722|STANDARD_ERROR_OF_MEAN|124.1956||0.013|TWO_SIDED|95.0|-551.4006|-64.0429|||Piecewise Linear Model|||Impairment in Daily Activities AUC72||-64.0429|-551.4006|0.013
73962393|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.13||||0.4074|TWO_SIDED|95.0|0.85|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=90% reduction||1.51|0.85|0.4074
73962394|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0296|TWO_SIDED|95.0|1.03|1.81|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=90% reduction||1.81|1.03|0.0296
73962395|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7607|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=30% reduction||1.23|0.86|0.7607
73903505|NCT01289782|147337468|SUPERIORITY_OR_OTHER||Mean differences|46.399|STANDARD_ERROR_OF_MEAN|99.7966||0.642|TWO_SIDED|95.0|-149.6374|242.436|||Piecewise linear model|||Time Missed from Work AUC60||242.4360|-149.6374|0.642
73903506|NCT01289782|147337468|SUPERIORITY_OR_OTHER||Mean differences|57.164|STANDARD_ERROR_OF_MEAN|115.1548||0.62|TWO_SIDED|95.0|-169.1143|283.4414|||Piecewise Linear Model|||Time Missed from Work AUC72||283.4414|-169.1143|0.620
73903507|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0081||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from baseline to post intervention||||0.0081
73903508|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0243||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from baseline to post intervention||||0.0243
73903509|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.071||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from baseline to post intervention||||0.0710
73903510|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0008||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from baseline to post intervention||||0.0008
73903511|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1094||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from baseline to one-month follow-up||||0.1094
73903512|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2029||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from baseline to one-month follow-up||||0.2029
73962396|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.02||||0.7979|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=30% reduction||1.22|0.86|0.7979
73962397|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.1||||0.2964|TWO_SIDED|95.0|0.92|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=50% reduction||1.31|0.92|0.2964
73853345|NCT02374060|147255224|SUPERIORITY||Difference in proportion|0.05||||0.54|TWO_SIDED|95.0|-0.12|0.22|||mixed effects model||Dexamethasone - intravitreal|||0.22|-0.12|0.54
73853346|NCT02374060|147255225|SUPERIORITY||Difference in mean change from BL|5.32||||0.003|TWO_SIDED|95.0|1.82|8.82|||mixed effects model||Intravitreal - periocular|||8.82|1.82|0.003
73853347|NCT02374060|147255225|SUPERIORITY||Difference in mean change from BL|5.16||||0.004|TWO_SIDED|95.0|1.6|8.72|||mixed effects model||Dexamethasone - periocular|||8.72|1.60|0.004
73853348|NCT02374060|147255225|SUPERIORITY||Difference in mean change from BL|-0.16||||0.93|TWO_SIDED|95.0|-3.67|3.34|||mixed effects model||Dexamethasone - intravitreal|||3.34|-3.67|0.93
73853349|NCT02374060|147255226|SUPERIORITY||Difference in mean change from BL|5.53||||0.013|TWO_SIDED|95.0|1.14|9.92|||mixed effects model||Intravitreal - periocular|||9.92|1.14|0.013
73853350|NCT02374060|147255226|SUPERIORITY||Difference in mean change from BL|5.14||||0.019|TWO_SIDED|95.0|0.84|9.44|||mixed effects model||Dexamethasone - periocular|||9.44|0.84|0.019
73853351|NCT02374060|147255226|SUPERIORITY||Difference in mean change from BL|-0.4||||0.84|TWO_SIDED|95.0|-4.16|3.37|||mixed effects model||Dexamethasone-intravitreal|||3.37|-4.16|0.84
73853352|NCT02374060|147255230|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.1|TWO_SIDED|95.0|0.09|1.24|||Regression, Cox||Intravitreal/Periocular|||1.24|0.09|0.10
73853353|NCT02374060|147255230|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.2|TWO_SIDED|95.0|0.14|1.5|||Regression, Cox||Dexamethasone/Periocular|||1.50|0.14|0.20
73853354|NCT02374060|147255230|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.62|TWO_SIDED|95.0|0.34|6.26|||Regression, Cox||Dexamethasone/Intravitreal|||6.26|0.34|0.62
73853355|NCT02374060|147255231|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.11|TWO_SIDED|95.0|0.86|4.29|||Regression, Cox||Intravitreal/Periocular|||4.29|0.86|0.11
73853356|NCT02374060|147255231|SUPERIORITY||Hazard Ratio (HR)|2.85||||0.009|TWO_SIDED|95.0|1.3|6.28|||Regression, Cox||Dexamethasone/Intravitreal|||6.28|1.30|0.009
73853357|NCT02374060|147255231|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.3|TWO_SIDED|95.0|0.72|2.81|||Regression, Cox||Dexamethasone/intravitreal|||2.81|0.72|0.30
73853358|NCT02374060|147255232|SUPERIORITY||Hazard Ratio (HR)|1.83||||0.09|TWO_SIDED|95.0|0.91|3.65|||Regression, Cox||Intravitreal/periocular|||3.65|0.91|0.09
73853359|NCT02374060|147255232|SUPERIORITY||Hazard Ratio (HR)|2.52||||0.007|TWO_SIDED|95.0|1.29|4.91|||Regression, Cox||Dexamethasone/periocular|||4.91|1.29|0.007
73853360|NCT02374060|147255232|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.37|TWO_SIDED|95.0|0.72|2.43|||Regression, Cox||Dexamethasone/intravitreal|||2.43|0.72|0.37
73853361|NCT02374060|147255233|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.92|TWO_SIDED|95.0|0.28|4.01|||Regression, Cox||Intravitreal/Periocular|||4.01|0.28|0.92
73853362|NCT02374060|147255233|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.65|TWO_SIDED|95.0|0.16|3.11|||Regression, Cox||Dexamethasone/Periocular|||3.11|0.16|0.65
73853363|NCT02374060|147255233|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.53|TWO_SIDED|95.0|0.16|2.59|||Regression, Cox||Dexamthasone/Intravitreal|||2.59|0.16|0.53
73853364|NCT03088930|147255239|OTHER||Summary statistics|0.0|||||TWO_SIDED|||||||||Three subjects enrolled. No statistical analysis completed due to low accrual.|Three subjects enrolled. No statistical analysis completed due to low accrual.|||
73853365|NCT01631747|147255271|SUPERIORITY|||||||0.01||||||p-value is not adjusted for multiple comparisons, and tested at an a priori type I error rate of 0.05.|t-test, 2 sided|||Sample size was based on an independent 2-sample t-test using a two-sided type 1 error rate of 0.05, and 80% power. Assuming a standard deviation (SD) of 15lbs (6.8kg), a clinically meaningful difference of 5lbs (2.4kg) between groups, and 10% attrition, a sample size of 150/group was required.||||0.01
73853366|NCT01631747|147255271|SUPERIORITY|||||||0.02|||||||Regression, Linear|adjusted for actual gestational age of 36 week weight, gestational age, bmi, and maternal age at randomization, maternal race and paternal race.||||||0.02
73853367|NCT01631747|147255272|SUPERIORITY|||||||0.54|||||||Chi-squared|||||||0.54
73853368|NCT01631747|147255273|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|T-test performed on change in glucose (log scale), but presented as Median and inter-quartile range for interpretability||||||0.89
73853369|NCT01631747|147255274|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|t-test performed on changes in HDL, but presented as median and IQR for ease of interpretation||||||0.30
73853370|NCT01631747|147255275|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|t-test run on changes between groups. Data presented as median and IQR for ease of interpretation||||||0.69
73853371|NCT01631747|147255276|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.19
73853372|NCT01631747|147255277|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|t-test used to compare changes between groups (log scale). Median and IQR are presented for ease of interpretation.||||||0.27
73853373|NCT01631747|147255278|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|t-test performed on changes between groups (log scale). Median and IQR are presented for ease of interpretation||||||0.003
73853374|NCT01631747|147255279|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.24
73853375|NCT01631747|147255280|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.32
73903513|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.8599||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from baseline to one-month follow-up||||0.8599
73903514|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0007||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from baseline to one-month follow-up||||0.0007
73903515|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0246||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from post-intervention to one-month follow-up||||0.0246
74024773|NCT02770807|147601849|SUPERIORITY||Odds Ratio (OR)|1.369||||0.4583|TWO_SIDED|95.0|0.597|3.144|||Ordinal Logistic Regression Analysis|||Odds ratio, confidence limits, and p-value derived using a proportional odds ordinal logistic regression analysis, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region, visit, baseline CGI-S score, and treatment-by- visit interaction as fixed effects.||3.144|0.597|0.4583
73903516|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.078||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from post-intervention to one-month follow-up||||0.0780
73962398|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.04||||0.695|TWO_SIDED|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=50% reduction||1.24|0.87|0.6950
73962399|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1985|TWO_SIDED|95.0|0.93|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=70% reduction||1.38|0.93|0.1985
73962400|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.17||||0.1239|TWO_SIDED|95.0|0.96|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=70% reduction||1.42|0.96|0.1239
73962401|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2762|TWO_SIDED|95.0|0.88|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=90% reduction||1.58|0.88|0.2762
73903517|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0167||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from post-intervention to one-month follow-up||||0.0167
73903518|NCT03239665|147337473|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.9417||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from post-intervention to one-month follow-up||||0.9417
73962402|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0121|TWO_SIDED|95.0|1.08|1.91|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=90% reduction||1.91|1.08|0.0121
73962403|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8443|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=30% reduction||1.22|0.85|0.8443
74024774|NCT02770807|147601849|SUPERIORITY||Odds Ratio (OR)|1.371||||0.4585|TWO_SIDED|95.0|0.595|3.16|||Ordinal Logistic Regression Analysis|||Odds ratio, confidence limits, and p-value derived using a proportional odds ordinal logistic regression analysis, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region, visit, baseline CGI-S score, and treatment-by- visit interaction as fixed effects.||3.160|0.595|0.4585
73903519|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0011||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to post-intervention"||||0.0011
73903520|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to post-intervention"||||<0.0001
74024775|NCT02770807|147601850|SUPERIORITY||Least squares means difference|-13.33||||0.7029|TWO_SIDED|95.0|-82.261|55.601|||ANCOVA|||Least squares means difference, associated statistics, and p-values derived using ANCOVA, with age (at 2 levels: \<10 years, \>=10 years), sex, treatment, region, and baseline VABS score as fixed effects.||55.601|-82.261|0.7029
74084889|NCT02459418|147723153|OTHER||Median Difference (Net)|2.14|||||TWO_SIDED|90.0|-9.91|12.29||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median difference and corresponding 90% CIs were was calculated using an Exact Hodges-Lehmann estimate with an exact confidence interval.||12.29|-9.91|
73903521|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0028||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to one-month follow-up"||||0.0028
73903522|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to one-month follow-up"||||<0.0001
73903523|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||1||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from post-intervention to one-month follow-up"||||1.0
73903524|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.643||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from post-intervention to one-month follow-up"||||0.6430
73903525|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1193||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to post-intervention"||||0.1193
73903526|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to post-intervention"||||<0.0001
73903527|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4861||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to one-month follow-up"||||0.4861
73903528|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0002||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to one-month follow-up"||||0.0002
73903529|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.3247||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from post-intervention to one-month follow-up"||||0.3247
73903530|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4627||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from post-intervention to one-month follow-up"||||0.4627
73903531|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1244||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.1244
73962404|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8472|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=30% reduction||1.22|0.85|0.8472
73962405|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.01||||0.898|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=50% reduction||1.21|0.85|0.8980
73962406|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9385|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=50% reduction||1.19|0.83|0.9385
73962407|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4261|TWO_SIDED|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=70% reduction||1.32|0.89|0.4261
73962408|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.07||||0.525|TWO_SIDED|95.0|0.88|1.3|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=70% reduction||1.30|0.88|0.5250
73903532|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0575||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.0575
73903533|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7489||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.7489
73903534|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0098||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0098
73903535|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1797||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.1797
73903536|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.3613||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.3613
73903537|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.5972||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.5972
73903538|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.024||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.0240
73903539|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2437||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.2437
73903540|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0631||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0631
73903541|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.054||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.0540
73903542|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7298||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.7298
73903543|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4218||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.4218
73903544|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2282||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.2282
73962409|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6273|TWO_SIDED|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=90% reduction||1.45|0.80|0.6273
73962410|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0132|TWO_SIDED|95.0|1.08|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=90% reduction||1.90|1.08|0.0132
74024776|NCT02770807|147601850|SUPERIORITY||Least squares means difference|-77.31||||0.0328|TWO_SIDED|95.0|-148.201|-6.421|||ANCOVA|||Least squares means difference, associated statistics, and p-values derived using ANCOVA, with age (at 2 levels: \<10 years, \>=10 years), sex, treatment, region, and baseline VABS score as fixed effects.||-6.421|-148.201|0.0328
73903545|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.8711||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.8711
73903546|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0027||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0027
73903547|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7579||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.7579
73903548|NCT03239665|147337474|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1299||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.1299
73903549|NCT03239665|147337476|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||1||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous engagement in the program immediately post-intervention via Fisher's Exact test||||1.0
73962411|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9095|TWO_SIDED|95.0|0.83|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=30% reduction||1.18|0.83|0.9095
73962412|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5098|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=30% reduction||1.12|0.79|0.5098
73962413|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4488|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=50% reduction||1.28|0.90|0.4488
73903550|NCT03239665|147337476|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||0.6806||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous engagement in the program at the one-month follow-up via Fisher's Exact test||||0.6806
73962414|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9757|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=50% reduction||1.19|0.83|0.9757
73962415|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1843|TWO_SIDED|95.0|0.94|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=70% reduction||1.39|0.94|0.1843
73962416|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4356|TWO_SIDED|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=70% reduction||1.32|0.89|0.4356
73962417|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6342|TWO_SIDED|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=90% reduction||1.45|0.80|0.6342
73962418|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.29||||0.081|TWO_SIDED|95.0|0.97|1.73|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=90% reduction||1.73|0.97|0.0810
74024777|NCT01056107|147601858|SUPERIORITY_OR_OTHER|||||||0.0075||95.0|||||Dunnett's test|||||||0.0075
74024778|NCT01056107|147601858|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's test|||||||<0.001
73903551|NCT03239665|147337476|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||1||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous satisfaction with the program's content immediately post-intervention via Fisher's Exact test||||1.0
73903552|NCT03239665|147337476|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||0.4908||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous satisfaction with the program's content at the one-month follow-up via Fisher's Exact test||||0.4908
73903553|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7728|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine at baseline via Chi-squared test||||0.7728
73903554|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6871|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine post-intervention via Chi-squared test||||0.6871
73903555|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8259|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine at one-month follow-up via Chi-squared test||||0.8259
73903556|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8868|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine at baseline via Chi-squared test||||0.8868
73903557|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8069|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine post-intervention via Chi-squared test||||0.8069
73903558|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8489|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine at one-month follow-up via Chi-squared test||||0.8489
73903559|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3985|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine at baseline via Chi-squared test||||0.3985
73962419|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6527|TWO_SIDED|95.0|0.8|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=30% reduction||1.15|0.80|0.6527
73962420|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|0.92||||0.3857|TWO_SIDED|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=30% reduction||1.10|0.77|0.3857
73903560|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.1722|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine post-intervention via Chi-squared test||||0.1722
73903561|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7318|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine at one-month follow-up via Chi-squared test||||0.7318
73903562|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6309|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive zoster vaccine post-intervention via Chi-squared test||||0.6309
73903563|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7881|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive zoster vaccine at one-month follow-up via Chi-squared test||||0.7881
73962421|NCT02528188|147460956|SUPERIORITY||Odds Ratio, log|1.06||||0.528|TWO_SIDED|95.0|0.89|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=50% reduction||1.27|0.89|0.5280
73962422|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5355|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=50% reduction||1.13|0.79|0.5355
74084890|NCT00835796|147723209|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|94.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109|94.2|
73903564|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6798|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive influenza vaccine post-intervention via Chi-squared test||||0.6798
73903565|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8548|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive influenza vaccine at one-month follow-up via Chi-squared test||||0.8548
73903566|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3182|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive pneumonia vaccine post-intervention via Chi-squared test||||0.3182
73903567|NCT03239665|147337477|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7986|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive pneumonia vaccine at one-month follow-up via Chi-squared test||||0.7986
73903568|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0163|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine at baseline via Chi-squared test||||0.0163
73903569|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0028|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine post-intervention via Chi-squared test||||0.0028
73903570|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0433|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine at one-month follow-up via Chi-squared test||||0.0433
73903571|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0592|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine at baseline via Chi-squared test||||0.0592
73903572|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.1843|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine post-intervention via Chi-squared test||||0.1843
73903573|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.5933|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine at one-month follow-up via Chi-squared test||||0.5933
73903574|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3942|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine at baseline via Chi-squared test||||0.3942
73903575|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9062|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine post-intervention via Chi-squared test||||0.9062
73903576|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9618|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine at one-month follow-up via Chi-squared test||||0.9618
73903577|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.114|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of zoster vaccine at one-month follow-up via Chi-squared test||||0.1140
73903578|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0141|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of influenza vaccine at one-month follow-up via Chi-squared test||||0.0141
73903579|NCT03239665|147337478|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0457|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of pneumonia vaccine at one-month follow-up via Chi-squared test||||0.0457
73962423|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7732|TWO_SIDED|95.0|0.84|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=70% reduction||1.26|0.84|0.7732
73962424|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9397|TWO_SIDED|95.0|0.82|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=70% reduction||1.23|0.82|0.9397
73903580|NCT03239665|147337479|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6153|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor at baseline via Chi-squared test||||0.6153
73962425|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9044|TWO_SIDED|95.0|0.75|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=90% reduction||1.39|0.75|0.9044
73962426|NCT02528188|147460956|SUPERIORITY||Odds Ratio (OR)|1.16||||0.3193|TWO_SIDED|95.0|0.86|1.57|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=90% reduction||1.57|0.86|0.3193
73962427|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1772|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.62|0.91|0.1772
73962428|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0154|TWO_SIDED|95.0|1.07|1.89|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.89|1.07|0.0154
73903581|NCT03239665|147337479|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8299|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor post-intervention via Chi-squared test||||0.8299
73903582|NCT03239665|147337479|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0405|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor at one-month follow-up via Chi-squared test||||0.0405
73903583|NCT03239665|147337479|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3776|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist at baseline via Chi-squared test||||0.3776
73903584|NCT03239665|147337479|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.2856|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist post-intervention via Chi-squared test||||0.2856
73903585|NCT03239665|147337479|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0016|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist at one-month follow-up via Chi-squared test||||0.0016
73903586|NCT03239665|147337479|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9449|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends at baseline via Chi-squared test||||0.9449
73903587|NCT03239665|147337479|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6143|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends post-intervention via Chi-squared test||||0.6143
73903588|NCT03239665|147337479|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0036|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends at one-month follow-up via Chi-squared test||||0.0036
73903589|NCT03239665|147337480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.|||||<|0.0001|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their doctor at one-month follow-up via Chi-squared test||||<0.0001
73903590|NCT03239665|147337480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0012|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their pharmacist at one-month follow-up via Chi-squared test||||0.0012
73903591|NCT03239665|147337480|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0034|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their family/friends at one-month follow-up via Chi-squared test||||0.0034
73903592|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs. Timolol|Mean Difference (Final Values)|-0.79|||||TWO_SIDED|95.0|-1.45|-0.13||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 8AM Difference between Implant Group 2 and timolol||-0.13|-1.45|
73903593|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.24|||||TWO_SIDED|95.0|-1.92|-0.56||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 10AM Difference between Implant Group 2 and timolol||-0.56|-1.92|
73962429|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0105|TWO_SIDED|95.0|1.08|1.81|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.81|1.08|0.0105
73903594|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.86|0.51||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 8AM Difference between Implant Group 2 and timolol||0.51|-0.86|
73903595|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-1.43|-0.11||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 10AM Difference between Implant Group 2 and timolol||-0.11|-1.43|
73962430|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0002|TWO_SIDED|95.0|1.26|2.1|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||2.10|1.26|0.0002
73962431|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4007|TWO_SIDED|95.0|0.87|1.43|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.43|0.87|0.4007
73962432|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0116|TWO_SIDED|95.0|1.07|1.75|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.75|1.07|0.0116
73962433|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|0.95||||0.6279|TWO_SIDED|95.0|0.76|1.18|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.18|0.76|0.6279
73962434|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|1.09||||0.4674|TWO_SIDED|95.0|0.87|1.35|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.35|0.87|0.4674
73962435|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3135|TWO_SIDED|95.0|0.71|1.12|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.12|0.71|0.3135
73962436|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7581|TWO_SIDED|95.0|0.83|1.3|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.30|0.83|0.7581
73962437|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|0.92||||0.4504|TWO_SIDED|95.0|0.73|1.15|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.15|0.73|0.4504
74084891|NCT00835796|147723210|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.7||||||90.0|94.0|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|94.0|
74084892|NCT00835796|147723211|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.8||||||90.0|94.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|94.5|
73853376|NCT01631747|147255281|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|T-test performed on change between groups (log scale). Median and IQR are presented for ease of interpretation||||||0.26
73853377|NCT01631747|147255282|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
73853378|NCT01631747|147255283|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
73853379|NCT01631747|147255284|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
73853380|NCT01631747|147255285|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
73853381|NCT01631747|147255286|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
73853382|NCT01631747|147255287|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
73853383|NCT01456195|147255288|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.72|-0.24||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.24|-0.72|<0.001
73853384|NCT01456195|147255288|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-1.0|-0.52||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.52|-1.00|<0.001
73853385|NCT01456195|147255289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.01|TWO_SIDED|95.0|1.2|3.79||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic|||||3.79|1.20|0.010
73853386|NCT01456195|147255289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.48|7.82||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic|||||7.82|2.48|<0.001
73853387|NCT01456195|147255290|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|4.59||0.003|TWO_SIDED|95.0|-22.7|-4.6||Mixed Model Repeated Measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-4.6|-22.7|0.003
73853388|NCT01456195|147255290|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-31.4|-13.2||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-13.2|-31.4|<0.001
73853389|NCT01456195|147255291|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.8|STANDARD_ERROR_OF_MEAN|17.17||0.1|TWO_SIDED|95.0|-63.2|5.7||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA|||||5.7|-63.2|0.100
73853390|NCT01456195|147255291|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.0|STANDARD_ERROR_OF_MEAN|17.7||0.096|TWO_SIDED|95.0|-65.5|5.5||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA|||||5.5|-65.5|0.096
73853391|NCT02150057|147255357|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73853392|NCT00394251|147255368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641|||||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity||||0.641
73853393|NCT00394251|147255374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.323||95.0|||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity||||0.323
73853394|NCT05791565|147255375|OTHER||Ratio of Geometric LS Means|1.1609|||||TWO_SIDED|90.0|1.0221|1.3185|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.3185|1.0221|
73853395|NCT05791565|147255376|OTHER||Ratio of the Geometric LS Means|1.4081|||||TWO_SIDED|90.0|1.2998|1.5255|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.5255|1.2998|
73853396|NCT05791565|147255377|OTHER||Ratio of the Geometric LS Means|1.3885|||||TWO_SIDED|90.0|1.2793|1.507|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.5070|1.2793|
73853397|NCT05791565|147255378|OTHER||Ratio of the Geometric LS Means|1.3141|||||TWO_SIDED|90.0|1.1816|1.4614|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.4614|1.1816|
73853398|NCT01696994|147255411|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.95|1.04|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.04|0.95|
73853399|NCT01696994|147255413|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.99|1.48|||Poisson regression|||||1.48|0.99|
73853400|NCT01696994|147255423|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.91|1.54||Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.|Poisson regression|||||1.54|.91|
73853401|NCT02388165|147255426|SUPERIORITY||Vaccine Efficacy (VE)|0.0|||||TWO_SIDED|95.0|-126.3|55.81|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The confidence interval (CI) was calculated using the Clopper-Pearson method.|||55.81|-126.30|
73853402|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|8.3|||<|0.001|TWO_SIDED|95.0|6.9|9.8|||Miettinen and Nurminen|||Redness: Any||9.8|6.9|<0.001
73853403|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|4.4|||||TWO_SIDED|95.0|3.3|5.6||||||Redness: Mild||5.6|3.3|
73853404|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|3.0|||||TWO_SIDED|95.0|2.3|4.0||||||Redness: Moderate||4.0|2.3|
73903596|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.63|0.82||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 8AM Difference between Implant Group 2 and timolol||0.82|-0.63|
73903597|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.89|0.57||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 10AM Difference between Implant Group 2 and timolol||0.57|-0.89|
73903598|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-0.72|||||TWO_SIDED|95.0|-1.38|-0.06||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 8AM Difference between Implant Group 1 vs. Timolol||-0.06|-1.38|
73903599|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-1.83|-0.48||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 10AM Difference between Implant Group 1 vs. Timolol||-0.48|-1.83|
73903600|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.93|0.43||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 8AM Difference between Implant Group 1 and timolol||0.43|-0.93|
73903601|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-0.74|||||TWO_SIDED|95.0|-1.4|-0.08||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 10AM Difference between Implant Group 1 and timolol||-0.08|-1.40|
73903602|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.62|0.83||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 8AM Difference between Implant Group 1 and timolol||0.83|-0.62|
73903603|NCT03519386|147337495|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.77|0.69||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 10AM Difference between Implant Group 1 and timolol||0.69|-0.77|
73903604|NCT01582854|147337532|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.82||0.005|TWO_SIDED|95.0|-3.9|-0.7|||ANCOVA|||||-0.7|-3.9|0.005
73903605|NCT01582854|147337533|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.74||0.122|TWO_SIDED|95.0|-2.6|0.3|||ANCOVA|||Month 3||0.3|-2.6|0.122
73903606|NCT01582854|147337533|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.93|<|0.001|TWO_SIDED|95.0|-5.5|-1.9|||ANCOVA|||Month 12||-1.9|-5.5|<0.001
73903607|NCT01582854|147337534|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.111|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||End of Infusion Period||0.7|-0.1|0.111
73962438|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|0.88||||0.2629|TWO_SIDED|95.0|0.7|1.1|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.10|0.70|0.2629
73962439|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|0.95||||0.6763|TWO_SIDED|95.0|0.75|1.2|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.75|0.6763
73962440|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9456|TWO_SIDED|95.0|0.8|1.27|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.27|0.80|0.9456
73903608|NCT01582854|147337534|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.27||0.016|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||Month 3||1.2|0.1|0.016
73903609|NCT01582854|147337534|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.29||0.013|TWO_SIDED|95.0|0.2|1.3|||ANCOVA|||Month 6||1.3|0.2|0.013
73903610|NCT01582854|147337534|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.34||0.003|TWO_SIDED|95.0|0.3|1.7|||ANCOVA|||Month 12||1.7|0.3|0.003
73903611|NCT01582854|147337535|SUPERIORITY_OR_OTHER||Percent Difference|10.2||||0.032|TWO_SIDED|95.0|0.9|19.5|||Chi-squared|||Month 3||19.5|0.9|0.032
73903612|NCT01582854|147337535|SUPERIORITY_OR_OTHER||Percent Difference|10.2||||0.034|TWO_SIDED|95.0|0.8|19.5|||Chi-squared|||Month 6||19.5|0.8|0.034
73903613|NCT01582854|147337535|SUPERIORITY_OR_OTHER||Percent Difference|10.1||||0.035|TWO_SIDED|95.0|0.8|19.3|||Chi-squared|||Month 12||19.3|0.8|0.035
73903614|NCT01582854|147337536|SUPERIORITY_OR_OTHER||Percent Difference|-3.2||||0.251|TWO_SIDED|95.0|-8.5|2.1|||Fisher Exact|||Month 6||2.1|-8.5|0.251
73903615|NCT01582854|147337536|SUPERIORITY_OR_OTHER||Percent Difference|-4.0||||0.221|TWO_SIDED|95.0|-9.7|1.7|||Fisher Exact|||Month 12||1.7|-9.7|0.221
73903616|NCT01582854|147337537|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||End of Infusion Period||0.1|-0.4|0.239
73903617|NCT01582854|147337537|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.136|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||Month 3||0.1|-0.5|0.136
73903618|NCT01582854|147337537|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.89|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|||Month 6||0.2|-0.3|0.890
73903619|NCT01582854|147337537|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.455|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Month 12||0.2|-0.4|0.455
73903620|NCT03101267|147337544|SUPERIORITY||Adjusted mean difference|0.09||||0.777|TWO_SIDED|95.0|-0.52|0.69|||Mixed model for repeated measures (MMRM)|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||3TNSS treatment comparison||0.69|-0.52|0.777
73903621|NCT03101267|147337544|SUPERIORITY||Adjusted mean difference|-0.01||||0.983||95.0|-0.61|0.59|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||3TNSS treatment comparison||0.59|-0.61|0.983
73903622|NCT03101267|147337545|SUPERIORITY||Adjusted mean difference|0.17||||0.71|TWO_SIDED|95.0|-0.75|1.1|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 127||1.10|-0.75|0.710
73903623|NCT03101267|147337545|SUPERIORITY||Adjusted mean difference|0.07||||0.872|TWO_SIDED|95.0|-0.84|0.99|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 127||0.99|-0.84|0.872
73903624|NCT03101267|147337545|SUPERIORITY||Adjusted mean difference|0.18||||0.701|TWO_SIDED|95.0|-0.73|1.08|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 155||1.08|-0.73|0.701
73903625|NCT03101267|147337545|SUPERIORITY||Adjusted mean difference|-0.04||||0.925||95.0|-0.95|0.86|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 155||0.86|-0.95|0.925
73903626|NCT03101267|147337545|SUPERIORITY||Adjusted mean difference|0.16||||0.69|TWO_SIDED|95.0|-0.64|0.97|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 183||0.97|-0.64|0.690
73903627|NCT03101267|147337545|SUPERIORITY||Adjusted mean difference|0.07||||0.868|TWO_SIDED|95.0|-0.73|0.87|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 183||0.87|-0.73|0.868
73903628|NCT03101267|147337546|SUPERIORITY||Adjusted mean difference|0.07||||0.502|TWO_SIDED|95.0|-0.14|0.29|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 127||0.29|-0.14|0.502
73903629|NCT03101267|147337546|SUPERIORITY||Adjusted mean difference|-0.02||||0.879|TWO_SIDED|95.0|-0.23|0.2|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 127||0.20|-0.23|0.879
73903630|NCT03101267|147337546|SUPERIORITY||Adjusted mean difference|0.06||||0.444|TWO_SIDED|95.0|-0.1|0.22|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 155||0.22|-0.10|0.444
73903631|NCT03101267|147337546|SUPERIORITY||Adjusted mean difference|0.0||||0.987|TWO_SIDED|95.0|-0.16|0.16|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 155||0.16|-0.16|0.987
73903632|NCT03101267|147337546|SUPERIORITY||Adjusted mean difference|0.03||||0.645|TWO_SIDED|95.0|-0.12|0.18|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 183||0.18|-0.12|0.645
73903633|NCT03101267|147337546|SUPERIORITY||Adjusted mean difference|-0.07||||0.357|TWO_SIDED|95.0|-0.22|0.08|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 183||0.08|-0.22|0.357
73903634|NCT03101267|147337547|SUPERIORITY||Adjusted mean difference|0.12||||0.472|TWO_SIDED|95.0|-0.2|0.44|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 127||0.44|-0.20|0.472
73903635|NCT03101267|147337547|SUPERIORITY||Adjusted mean difference|-0.11||||0.497|TWO_SIDED|95.0|-0.43|0.21|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 127||0.21|-0.43|0.497
73903636|NCT03101267|147337547|SUPERIORITY||Adjusted mean difference|0.04||||0.821|TWO_SIDED|95.0|-0.28|0.36|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 155||0.36|-0.28|0.821
73903637|NCT03101267|147337547|SUPERIORITY||Adjusted mean difference|-0.13||||0.414|TWO_SIDED|95.0|-0.45|0.19|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 155||0.19|-0.45|0.414
73903638|NCT03101267|147337547|SUPERIORITY||Adjusted mean difference|0.12||||0.414|TWO_SIDED|95.0|-0.17|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 183||0.41|-0.17|0.414
73903639|NCT03101267|147337547|SUPERIORITY||Adjusted mean difference|0.08||||0.566|TWO_SIDED|95.0|-0.2|0.37|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 183||0.37|-0.20|0.566
73903640|NCT03101267|147337548|SUPERIORITY||Adjusted mean difference|-0.04||||0.822||95.0|-0.37|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 127||0.30|-0.37|0.822
73903641|NCT03101267|147337548|SUPERIORITY||Adjusted mean difference|0.09||||0.587|TWO_SIDED|95.0|-0.24|0.42|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 127||0.42|-0.24|0.587
73903642|NCT03101267|147337548|SUPERIORITY||Adjusted mean difference|0.0||||0.975|TWO_SIDED|95.0|-0.3|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 155||0.31|-0.30|0.975
74084893|NCT00979212|147723288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||||||One-sided test at significance level of 0.05|Fisher Exact|||Null hypothesis (H0) was that the experimental treatment was not effective vs the alternative hypothesis (HA) that it was. H0: OR ≤ 1 vs. HA: OR \> 1, where odds ratio (OR)= \[p2\*(1- p1)\]/ \[p1\*(1- p2)\], p1 denotes the mediastinal clearance rate (MCR) on Induction chemoradiation; p2 denotes the MCR on Induction chemoradiation + panitumumab. Fisher's exact test was used to compare the MCRs; the 95% confidence interval was calculated using Clopper-Pearson method. 97 patients were required.||||0.96
73903643|NCT03101267|147337548|SUPERIORITY||Adjusted mean difference|0.0||||0.98|TWO_SIDED|95.0|-0.31|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 155||0.31|-0.31|0.980
73903644|NCT03101267|147337548|SUPERIORITY||Adjusted mean difference|-0.07||||0.621|TWO_SIDED|95.0|-0.35|0.21|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 183||0.21|-0.35|0.621
73903645|NCT03101267|147337548|SUPERIORITY||Adjusted mean difference|-0.03||||0.831|TWO_SIDED|95.0|-0.31|0.25|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 183||0.25|-0.31|0.831
73903646|NCT03101267|147337549|SUPERIORITY||Adjusted mean difference|0.03||||0.864|TWO_SIDED|95.0|-0.29|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 127||0.35|-0.29|0.864
73903647|NCT03101267|147337549|SUPERIORITY||Adjusted mean difference|0.11||||0.502|TWO_SIDED|95.0|-0.21|0.43|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 127||0.43|-0.21|0.502
73903648|NCT03101267|147337549|SUPERIORITY||Adjusted mean difference|0.07||||0.652|TWO_SIDED|95.0|-0.25|0.4|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 155||0.40|-0.25|0.652
74084894|NCT04269993|147723295|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.04|TWO_SIDED||||||t-test, 1 sided|||||||0.04
73903649|NCT03101267|147337549|SUPERIORITY||Adjusted mean difference|0.08||||0.633|TWO_SIDED|95.0|-0.25|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 155||0.41|-0.25|0.633
73903650|NCT03101267|147337549|SUPERIORITY||Adjusted mean difference|0.07||||0.596|TWO_SIDED|95.0|-0.2|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 183||0.35|-0.20|0.596
73903651|NCT03101267|147337549|SUPERIORITY||Adjusted mean difference|0.07||||0.621|TWO_SIDED|95.0|-0.21|0.34|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 183||0.34|-0.21|0.621
73903652|NCT03101267|147337550|SUPERIORITY||Adjusted mean difference|0.21||||0.336|TWO_SIDED|95.0|-0.22|0.65|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 127||0.65|-0.22|0.336
73903653|NCT03101267|147337550|SUPERIORITY||Adjusted mean difference|0.36||||0.102|TWO_SIDED|95.0|-0.07|0.8|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 127||0.80|-0.07|0.102
73903654|NCT03101267|147337550|SUPERIORITY||Adjusted mean difference|0.11||||0.625|TWO_SIDED|95.0|-0.34|0.56|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 155||0.56|-0.34|0.625
73903655|NCT03101267|147337550|SUPERIORITY||Adjusted mean difference|0.33||||0.145|TWO_SIDED|95.0|-0.12|0.78|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 155||0.78|-0.12|0.145
74088279|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-6.18|STANDARD_ERROR_OF_MEAN|1.61||0.0001|TWO_SIDED|95.0|-9.34|-3.03|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-3.03|-9.34|0.0001
74088280|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-9.13|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-12.26|-6.0|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-6.00|-12.26|<.0001
73853405|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|0.5|1.4||||||Redness: Severe||1.4|0.5|
73853406|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|7.0|||<|0.001|TWO_SIDED|95.0|5.7|8.4|||Miettinen and Nurminen|||Swelling: Any||8.4|5.7|<0.001
73853407|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|3.9|||||TWO_SIDED|95.0|2.8|5.0||||||Swelling: Mild||5.0|2.8|
73853408|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|2.4|||||TWO_SIDED|95.0|1.7|3.3||||||Swelling: Moderate||3.3|1.7|
73853409|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|0.7|||||TWO_SIDED|95.0|0.4|1.2||||||Swelling: Severe||1.2|0.4|
73853410|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|15.7|||<|0.001|TWO_SIDED|95.0|13.3|18.1|||Miettinen and Nurminen|||Pain at the injection site: Any||18.1|13.3|<0.001
73853411|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|12.2|||||TWO_SIDED|95.0|10.0|14.5||||||Pain at the injection site: Mild||14.5|10.0|
73853412|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|3.0|||||TWO_SIDED|95.0|1.9|4.2||||||Pain at the injection site: Moderate||4.2|1.9|
73853413|NCT02388165|147255427|SUPERIORITY||Difference in percentage of participants|0.5|||||TWO_SIDED|95.0|0.1|1.0||||||Pain at the injection site: Severe||1.0|0.1|
73853414|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.6||||0.146|TWO_SIDED|95.0|-0.2|1.6|||Miettinen and Nurminen|||Fever: Any||1.6|-0.2|0.146
73853415|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.4|||||TWO_SIDED|95.0|-0.3|1.2||||||Fever: 38.0 degree C to 38.4 degree C||1.2|-0.3|
73853416|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.4|0.6||||||Fever: 38.5 degree C to 38.9 degree C||0.6|-0.4|
73853417|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.2|0.5||||||Fever: 39.0 degree C to 40.0 degree C||0.5|-0.2|
73853418|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.2|0.3||||||Fever: \>40.0 degree C||0.3|-0.2|
73853419|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|2.9||||0.093||95.0|-0.5|6.2|||Miettinen and Nurminen|||Fatigue: Any||6.2|-0.5|0.093
73853420|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-0.9|3.7||||||Fatigue: Mild||3.7|-0.9|
73853421|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|1.3|||||TWO_SIDED|95.0|-1.6|4.2||||||Fatigue: Moderate||4.2|-1.6|
73853422|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.2|||||TWO_SIDED|95.0|-1.2|1.6||||||Fatigue: Severe||1.6|-1.2|
73853423|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|1.2||||0.443|TWO_SIDED|95.0|-1.9|4.4|||Miettinen and Nurminen|||Headache: Any||4.4|-1.9|0.443
73853424|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|-0.3|||||TWO_SIDED|95.0|-2.9|2.3||||||Headache: Mild||2.3|-2.9|
73853425|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|1.5|||||TWO_SIDED|95.0|-0.7|3.8||||||Headache: Moderate||3.8|-0.7|
73853426|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.0|||||TWO_SIDED|95.0|-0.8|0.8||||||Headache: Severe||0.8|-0.8|
73853427|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|1.0||||0.462|TWO_SIDED|95.0|-1.6|3.4|||Miettinen and Nurminen|||Diarrhea: Any||3.4|-1.6|0.462
73853428|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|-1.5|3.0||||||Diarrhea: Mild||3.0|-1.5|
73853429|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.5||||||95.0|-0.7|1.7||||||Diarrhea: Moderate||1.7|-0.7|
73853430|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||Diarrhea: Severe||0.2|-1.0|
73853431|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|-0.6||||0.3||95.0|-1.8|0.5|||Miettinen and Nurminen|||Vomiting: Any||0.5|-1.8|0.300
73853432|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|-0.2|||||TWO_SIDED|95.0|-1.3|0.8||||||Vomiting: Mild||0.8|-1.3|
73853433|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|-0.4||||||95.0|-0.9|0.1||||||Vomiting: Moderate||0.1|-0.9|
73853434|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|1.7||||0.276||95.0|-1.3|4.7|||Miettinen and Nurminen|||Muscle pain: Any||4.7|-1.3|0.276
73853435|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|-1.2|2.8||||||Muscle pain: Mild||2.8|-1.2|
73853436|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-1.4|3.5||||||Muscle pain: Moderate||3.5|-1.4|
73853437|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|-0.2||||||95.0|-1.2|0.8||||||Muscle pain: Severe||0.8|-1.2|
73853438|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|1.7||||0.273|TWO_SIDED|95.0|-1.3|4.6|||Miettinen and Nurminen|||Joint pain: Any||4.6|-1.3|0.273
73853439|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|1.6|||||TWO_SIDED|95.0|-0.2|3.6||||||Joint pain: Mild||3.6|-0.2|
73853440|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.0|||||TWO_SIDED|95.0|-2.6|2.4||||||Joint pain: Moderate||2.4|-2.6|
73853441|NCT02388165|147255428|SUPERIORITY||Difference in percentage of participants|0.1||||||95.0|-0.9|1.0||||||Joint pain: Severe||1.0|-0.9|
73853442|NCT02388165|147255436|SUPERIORITY||VE|0.0|||||TWO_SIDED|95.0|-126.3|55.81|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||55.81|-126.30|
74088281|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.79||0.0008|TWO_SIDED|95.0|-9.51|-2.5|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.50|-9.51|0.0008
73903656|NCT03101267|147337550|SUPERIORITY||Adjusted mean difference|0.19||||0.364|TWO_SIDED|95.0|-0.22|0.59|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 183||0.59|-0.22|0.364
73903657|NCT03101267|147337550|SUPERIORITY||Adjusted mean difference|0.35||||0.082|TWO_SIDED|95.0|-0.05|0.76|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 183||0.76|-0.05|0.082
73903658|NCT03101267|147337551|SUPERIORITY||Adjusted mean difference|0.07||||0.623|TWO_SIDED|95.0|-0.21|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 127||0.35|-0.21|0.623
73903659|NCT03101267|147337551|SUPERIORITY||Adjusted mean difference|0.15||||0.288|TWO_SIDED|95.0|-0.13|0.43|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 127||0.43|-0.13|0.288
73903660|NCT03101267|147337551|SUPERIORITY||Adjusted mean difference|0.03||||0.83|TWO_SIDED|95.0|-0.24|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 155||0.30|-0.24|0.830
73903661|NCT03101267|147337551|SUPERIORITY||Adjusted mean difference|0.17||||0.208|TWO_SIDED|95.0|-0.1|0.44|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 155||0.44|-0.10|0.208
73903662|NCT03101267|147337551|SUPERIORITY||Adjusted mean difference|0.06||||0.616|TWO_SIDED|95.0|-0.19|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 183||0.31|-0.19|0.616
73903663|NCT03101267|147337551|SUPERIORITY||Adjusted mean difference|0.16||||0.207|TWO_SIDED|95.0|-0.09|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 183||0.41|-0.09|0.207
73903664|NCT03101267|147337552|SUPERIORITY||Adjusted mean difference|0.15||||0.157|TWO_SIDED|95.0|-0.06|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 127||0.35|-0.06|0.157
73903665|NCT03101267|147337552|SUPERIORITY||Adjusted mean difference|0.21||||0.039|TWO_SIDED|95.0|0.01|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 127||0.41|0.01|0.039
73903666|NCT03101267|147337552|SUPERIORITY||Adjusted mean difference|0.08||||0.459|TWO_SIDED|95.0|-0.14|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 155||0.30|-0.14|0.459
73903667|NCT03101267|147337552|SUPERIORITY||Adjusted mean difference|0.16||||0.153|TWO_SIDED|95.0|-0.06|0.38|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 155||0.38|-0.06|0.153
73903668|NCT03101267|147337552|SUPERIORITY||Adjusted mean difference|0.12||||0.195|TWO_SIDED|95.0|-0.06|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 183||0.31|-0.06|0.195
73962441|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|0.96||||0.752|TWO_SIDED|95.0|0.76|1.22|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.76|0.7520
73962442|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9981|TWO_SIDED|95.0|0.79|1.26|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.26|0.79|0.9981
73903669|NCT03101267|147337552|SUPERIORITY||Adjusted mean difference|0.2||||0.038|TWO_SIDED|95.0|0.01|0.38|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 183||0.38|0.01|0.038
73903670|NCT03101267|147337553|SUPERIORITY||Adjusted mean difference|0.37||||0.433|TWO_SIDED|95.0|-0.56|1.29|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 127||1.29|-0.56|0.433
73903671|NCT03101267|147337553|SUPERIORITY||Adjusted mean difference|0.33||||0.479|TWO_SIDED|95.0|-0.59|1.24|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 127||1.24|-0.59|0.479
73962443|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|0.93||||0.5284|TWO_SIDED|95.0|0.74|1.17|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.17|0.74|0.5284
73962444|NCT02528188|147460958|SUPERIORITY||Odds Ratio (OR)|0.89||||0.322|TWO_SIDED|95.0|0.7|1.12|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.12|0.70|0.3220
73903672|NCT03101267|147337553|SUPERIORITY||Adjusted mean difference|0.22||||0.648|TWO_SIDED|95.0|-0.71|1.14|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 155||1.14|-0.71|0.648
73903673|NCT03101267|147337553|SUPERIORITY||Adjusted mean difference|0.21||||0.654|TWO_SIDED|95.0|-0.72|1.14|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 155||1.14|-0.72|0.654
73962445|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.112|TWO_SIDED|95.0|-0.02|0.2|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.20|-0.02|0.1120
73962446|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9686|TWO_SIDED|95.0|-0.11|0.11|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.11|-0.11|0.9686
73962447|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.1589|TWO_SIDED|95.0|-0.25|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.04|-0.25|0.1589
73962448|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.472|TWO_SIDED|95.0|-0.2|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.09|-0.20|0.4720
73962449|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.33|-0.01|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.01|-0.33|0.0320
73962450|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3336|TWO_SIDED|95.0|-0.24|0.08|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.24|0.3336
73962451|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.47|-0.13|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.13|-0.47|0.0005
73962452|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09||0.0001|TWO_SIDED|95.0|-0.5|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.16|-0.50|0.0001
73962453|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.55|-0.18|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.18|-0.55|<0.0001
73962454|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.66|-0.3|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.30|-0.66|<0.0001
73962455|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0115|TWO_SIDED|95.0|-0.42|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.05|-0.42|0.0115
73962456|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.63|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.26|-0.63|<0.0001
73962457|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.56|-0.17|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.17|-0.56|0.0002
73962458|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.28|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.28|-0.67|<0.0001
74024779|NCT01896232|147601950|NON_INFERIORITY_OR_EQUIVALENCE|Etelcalcetide was considered non-inferior to cinacalcet if the upper bound of the 2-sided 95% confidence interval (CI) of the treatment difference (cinacalcet - etelcalcetide) was \< 12%, the prespecified margin for non-inferiority.|Stratified Treatment Difference|-10.48|||||TWO_SIDED|95.0|-17.45|-3.51||||||"The analysis was conducted on the Full Analysis Set (683 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment difference between the proportions (Cinacalcet - Etelcalcetide) stratified by screening PTH level and region."||-3.51|-17.45|
74024780|NCT01896232|147601951|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.001|TWO_SIDED|95.0|1.21|2.23|||Cochran-Mantel-Haenszel||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of \> 50% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||2.23|1.21|0.001
74024781|NCT01896232|147601952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.004|TWO_SIDED|95.0|1.16|2.17|||Cochran-Mantel-Haenszel||The CMH stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of \> 30% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||2.17|1.16|0.004
74024782|NCT01896232|147601953|SUPERIORITY_OR_OTHER||Treatment Rate Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.15||0.27|TWO_SIDED|95.0|0.89|1.49|||Generalized Linear Mixed Model||The treatment rate ratio is Etelcalcetide : Cinacalcet.|"Analyzed using a generalized linear mixed model with Poisson regression, including screening value of the number of days of nausea and vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||1.49|0.89|0.27
74024783|NCT01896232|147601954|SUPERIORITY_OR_OTHER||Treatment difference|-3.48|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-4.76|-2.21|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using a repeated measures mixed effects model, including treatment group, randomization stratification factors (screening PTH level and region), study week, and study week by treatment as fixed effects.||-2.21|-4.76|
74024784|NCT01896232|147601955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.59|||||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|Analyzed using the Cochran-Mantel-Haenszel method stratified by screening PTH level and region.||1.59|0.83|
74024785|NCT01896232|147601956|SUPERIORITY_OR_OTHER||Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.18|0.12|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using an analysis of covariance (ANCOVA) model adjusted for screening PTH level and region.||0.12|-0.18|
73903674|NCT03101267|147337553|SUPERIORITY||Adjusted mean difference|0.27||||0.514|TWO_SIDED|95.0|-0.55|1.09|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 183||1.09|-0.55|0.514
73903675|NCT03101267|147337553|SUPERIORITY||Adjusted mean difference|0.35||||0.4|TWO_SIDED|95.0|-0.47|1.17|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 183||1.17|-0.47|0.400
73903676|NCT03101267|147337554|SUPERIORITY||Adjusted mean difference,|0.39||||0.505|TWO_SIDED|95.0|-0.76|1.54||The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.|MMRM|||6TSS treatment comparison at day 127||1.54|-0.76|0.505
74024786|NCT01896232|147601957|SUPERIORITY_OR_OTHER||Treatment Rate Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|0.86|1.72|||||The treatment rate ratio is Etelcalcetide : Cinacalcet.|This analysis was conducted using a generalized linear mixed model with Poisson regression including screening value of the number of episodes of vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.||1.72|0.86|
73903677|NCT03101267|147337554|SUPERIORITY||Adjusted mean difference,|0.44||||0.451|TWO_SIDED|95.0|-0.71|1.58|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 127||1.58|-0.71|0.451
74024787|NCT00686205|147601958|SUPERIORITY_OR_OTHER||Clinical Specificity|99.94||||||95.0|99.88|99.97|||Binomial Exact|Sample size is based on power of 80%, alpha level of 0.05, using the binomial distribution when comparing to a lower bound of specificity at 99.84.||||99.97|99.88|
74024788|NCT00686205|147601959|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0||||||95.0|99.76|100.0|||Binomial Exact|||||100.00|99.76|
74024789|NCT00265941|147601960|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.76|TWO_SIDED|95.0|0.88|1.32|||Log Rank||Reference arm = RT + cisplatin|A total of 945 patients were required (900 analyzable) to test for a 25% reduction in the hazard associated with progression-free survival with 84% statistical power using a one-sided log-rank test at the 0.025 significance level (0.0238 after 3 interim analyses).||1.32|0.88|0.76
74024790|NCT00265941|147601961|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.32|TWO_SIDED|95.0|0.74|1.21|||Log Rank|One-sided log-rank significance level of 0.025|Reference level = RT + cisplatin|Arms were compared using a one-sided log-rank test at the 0.025 significance level.||1.21|0.74|0.32
74024791|NCT00265941|147601962|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.97|TWO_SIDED|95.0|0.99|1.7|||Log Rank|One-sided significance level of 0.025|Reference level = RT + cisplatin|||1.70|0.99|0.97
74024792|NCT00265941|147601967|SUPERIORITY|||||||0.74|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||3 months||||0.74
74024793|NCT00265941|147601967|SUPERIORITY|||||||0.99|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||12 months||||0.99
74024794|NCT00265941|147601968|SUPERIORITY|||||||0.13|||||||Chi-squared|2-sided significance level of 0.05||Diet 3-month||||0.13
74024795|NCT00265941|147601968|SUPERIORITY|||||||0.87|||||||Chi-squared|2-sided significance level 0.05||Diet 12-month||||0.87
74024796|NCT00265941|147601968|SUPERIORITY|||||||0.39|||||||Chi-squared|2-sided significance level of 0.05||Eating 3-month||||0.39
73903678|NCT03101267|147337554|SUPERIORITY||Adjusted mean difference,|0.29||||0.623|TWO_SIDED|95.0|-0.88|1.46|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 155||1.46|-0.88|0.623
73903679|NCT03101267|147337554|SUPERIORITY||Adjusted mean difference,|0.29||||0.62|TWO_SIDED|95.0|-0.87|1.46|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 155||1.46|-0.87|0.620
73903680|NCT03101267|147337554|SUPERIORITY||Adjusted mean difference,|0.35||||0.504|TWO_SIDED|95.0|-0.68|1.37|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 183||1.37|-0.68|0.504
73903681|NCT03101267|147337554|SUPERIORITY||Adjusted mean difference,|0.42||||0.414|TWO_SIDED|95.0|-0.6|1.45|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 183||1.45|-0.60|0.414
73903682|NCT01262352|147337572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.069||||0.0004|TWO_SIDED|95.0|-2.98|-1.15|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a mixed effect model. The model included the absolute change from the baseline in each period as the dependent variable, sequence, treatment, and period as fixed effects, study baseline LCI as the covariate, and subject nested within sequence as the random effect.||-1.15|-2.98|0.0004
73903683|NCT01262352|147337573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.007||||0.0117|TWO_SIDED|95.0|1.8|12.21||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for this efficacy variable was performed in a similar way as the analysis for the primary efficacy variable.||12.21|1.80|0.0117
73903684|NCT01262352|147337574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.848|||<|0.0001|TWO_SIDED|95.0|-53.54|-38.16||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for change from baseline in average sweat chloride was similar to the analysis of the primary efficacy variable.||-38.16|-53.54|<0.0001
73903685|NCT01262352|147337575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.991||||0.3796|TWO_SIDED|95.0|-5.4|13.39||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||The raw scores in CFQ-R were summarized into different domains of health (12 domains for adolescents and adults 14 years of age and older, 8 domains for children ages 12 and 13 years, 8 domains for children ages 6 to 11 years, and 11 domains for parents/caregivers). Each domain was analyzed in a similar way as for the primary efficacy variable. The primary analytical focus was the respiratory health domain which was analyzed by combining all self-response questionnaire versions.||13.39|-5.40|0.3796
73903686|NCT00107952|147337590|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|-1.6||||||95.0|-8.6|5.5||p-values were not calculated in deference to confidence intervals.|||"Statistical analysis applies to cure"|||5.5|-8.6|
73903687|NCT01390220|147337635|SUPERIORITY|||||||0.0109|||||||Fisher Exact|2-sided||||||0.0109
73903688|NCT01390220|147337636|SUPERIORITY|||||||0.0043|||||||Fisher Exact|2-sided||||||0.0043
73903689|NCT01390220|147337637|SUPERIORITY|||||||0.0124|||||||Log Rank|||||||0.0124
73962459|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.57|-0.18|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.18|-0.57|0.0002
73903690|NCT01390220|147337638|SUPERIORITY|||||||0.0124|||||||Log Rank|||Kaplan-Meier estimates.||||0.0124
73903691|NCT01856023|147337656|SUPERIORITY|one -sample binomial test - 1-year estimated OS for these 28 patients was 75% (95%CI: 51%, 88%)||||||0.001||||||compared to the historical control rate of 46% one year survival|Log Rank|||OS rates of the Evaluable population in entire cohort was compared with the historical control rate of 46% (Hodi, et al NEJM 2010) using a one-sample binomial test due to early termination of enrollment without reaching target accrual; planned analysis to be the difference between treatment arms using log-rank test. One year OS along with 95% CI estimated for entire population and each treatment arm separately.||||.001
73903692|NCT04718103|147337662|SUPERIORITY|Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted Forced Expiratory Volume in one second (FEV1) and offset of log (total time in the study in years).|Rate Ratio|0.52|||<|0.001|TWO_SIDED|95.0|0.36|0.73|||Negative Binomial Distribution|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.||0.73|0.36|<0.001
73903693|NCT04718103|147337663|SUPERIORITY||Least-square (LS) means|-2.31||||0.2|TWO_SIDED|95.0|-5.84|1.23|||Mixed Models Repeated Measures (MMRM)|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by SGRQ Total Score measured over the study intervention period of 52 weeks.||1.23|-5.84|0.200
73903694|NCT04718103|147337664|SUPERIORITY||Difference in Least-Square Mean|-0.11||||0.333|TWO_SIDED|95.0|-0.33|0.11|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.||0.11|-0.33|0.333
73903695|NCT04718103|147337665|SUPERIORITY||Difference in Least-Square Means|0.056||||0.267|TWO_SIDED|95.0|-0.043|0.154|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.||0.154|-0.043|0.267
73903696|NCT04718103|147337666|SUPERIORITY||Difference in Least square means|-0.21||||0.173|TWO_SIDED|95.0|-0.52|0.09|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.||0.09|-0.52|0.173
73853443|NCT02388165|147255437|SUPERIORITY||VE|-9.09|||||TWO_SIDED|95.0|-104.06|41.41|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||41.41|-104.06|
73853444|NCT02388165|147255438|SUPERIORITY||VE|-8.7|||||TWO_SIDED|95.0|-100.42|40.8|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||40.80|-100.42|
73853445|NCT03215758|147255481|SUPERIORITY||Mean Difference (Net)|0.0238||||0.088|TWO_SIDED|95.0|-0.006|0.088|||ANCOVA|||||0.088|-0.006|0.088
73903697|NCT04718103|147337667|SUPERIORITY||Difference in Least square means|-0.21||||0.138|TWO_SIDED|95.0|-0.48|0.07|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.||0.07|-0.48|0.138
73903698|NCT04718103|147337668|SUPERIORITY|Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted FEV1.|Rate Ratio|0.42||||0.087|TWO_SIDED|95.0|0.16|1.13|||Negative binomial distribution|||||1.13|0.16|0.087
73903699|NCT00136604|147337669|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) on the difference in the percentage of subjects with SBA-MenC titre ≥ 1:128 between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the TRITANRIX-HEPB+Mencevax + Meningitec control group was above -10%.|Difference in percentage of subjects|0.0|||||TWO_SIDED|95.0|-1.53|3.05||||||Demonstration of non-inferiority of a fourth dose of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus a fourth dose of the Tritanrix-HepB/Hiberix and Meningitec vaccine given concomitantly in terms of the percentage of subjects with an SBA-MenC titre ≥ 1:128.||3.05|-1.53|
73903700|NCT00136604|147337671|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% CI on the difference in seroprotection (anti-PRP concentration ≥ 1.0 µg/mL) between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix Group was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.53|3.05||||||Demonstration of non-inferiority of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus the Tritanrix-HepB/Hiberix vaccine when used as a booster vaccine in Tritanrix-HepB/Hib-MenAC-TT primed subjects in terms of the percentage of subjects with an anti-PRP concentration ≥ 1.0 µg/mL.||3.05|-1.53|
73853446|NCT03215758|147255482|SUPERIORITY||Mean Difference (Net)|-0.06||||0.278|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||||0.05|-0.16|0.278
73853447|NCT03215758|147255483|SUPERIORITY||Mean Difference (Net)|-0.08||||0.429|TWO_SIDED|95.0|-0.3|0.13|||ANCOVA|||||0.13|-0.30|0.429
73853448|NCT03215758|147255484|SUPERIORITY||Mean Difference (Net)|0.069||||0.777|TWO_SIDED|95.0|-0.12|0.15|||ANCOVA|||||0.15|-0.12|0.777
73903701|NCT00495131|147337763|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Null hypothesis: no difference between 2 groups SVR estimation: 24 weeks (60%), 48 weeks (75%) alfa erros: 0.05, power: 0.80||||< 0.001
73903702|NCT00744471|147337815|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.87|-0.69||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.69|-1.87|<0.001
73903703|NCT00744471|147337815|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.28|-1.1||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.10|-2.28|<0.001
73903704|NCT00744471|147337815|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.34|-1.16||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.16|-2.34|<0.001
74024797|NCT00265941|147601968|SUPERIORITY|||||||0.16|||||||Chi-squared|2-sided significance level of 0.05||Eating 12-month||||0.16
73853449|NCT01942668|147255486|SUPERIORITY||Mean Difference (Final Values)|-12.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-6.32|-19.29|<0.001
73853450|NCT01942668|147255486|SUPERIORITY||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|3.25||0.013|TWO_SIDED|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-1.68|-14.46|0.013
73853451|NCT01942668|147255486|SUPERIORITY||Mean Difference (Final Values)|-4.81|STANDARD_ERROR_OF_MEAN|3.26||0.141|TWO_SIDED|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||1.59|-11.21|0.141
73853452|NCT01942668|147255486|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.22||0.001|TWO_SIDED|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-4.08|-16.73|0.001
73853453|NCT01942668|147255487|SUPERIORITY||Mean Difference (Final Values)|-16.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-9.82|-23.33|<0.001
73853454|NCT01942668|147255487|SUPERIORITY||Mean Difference (Final Values)|-15.07|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-8.42|-21.72|<0.001
73853455|NCT01942668|147255487|SUPERIORITY||Mean Difference (Final Values)|-10.79|STANDARD_ERROR_OF_MEAN|3.41||0.002|TWO_SIDED|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-4.10|-17.48|0.002
73853456|NCT01942668|147255487|SUPERIORITY||Mean Difference (Final Values)|-11.71|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-5.11|-18.31|<0.001
73853457|NCT01942668|147255488|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.061||0.031|TWO_SIDED|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.01|-0.25|0.031
73853458|NCT01942668|147255488|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.005|TWO_SIDED|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.05|-0.28|0.005
73853459|NCT01942668|147255488|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.401|TWO_SIDED|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.07|-0.17|0.401
73853460|NCT01942668|147255488|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.059||0.1|TWO_SIDED|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.02|-0.21|0.100
73853461|NCT01942668|147255489|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.38|-0.77|<0.001
73853462|NCT01942668|147255489|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.20|-0.59|<0.001
74024798|NCT00265941|147601968|SUPERIORITY|||||||0.81|||||||Chi-squared|2-sided significance level of 0.05||Speech 3-month||||0.81
74024799|NCT00265941|147601968|SUPERIORITY|||||||0.67|||||||Chi-squared|2-sided significance level of 0.05||Speech 12-month||||0.67
74024800|NCT00265941|147601969|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|2-sided significance level of 0.05||||||0.016
74024801|NCT00265941|147601970|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6|TWO_SIDED|95.0|0.79|1.51|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Progression-free survival is compared between favorable risk and unfavorable risk groups.||1.51|0.79|0.60
74024802|NCT00265941|147601970|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.37|TWO_SIDED|95.0|0.81|1.76|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Overall survival is compared between favorable risk and unfavorable risk groups.||1.76|0.81|0.37
74024803|NCT00265941|147601970|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.76|TWO_SIDED|95.0|0.6|1.46|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Local-regional failure||1.46|0.60|0.76
74024804|NCT00265941|147601971|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|0.12|0.75|||Log Rank|2-sided significance level = 0.05|Reference level = low|Progression-free survival is compared between low and high SUVmax groups.||0.75|0.12|0.01
74024805|NCT00265941|147601971|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.1|TWO_SIDED|95.0|0.12|1.2|||Log Rank|2-sided significance level = 0.05|Reference level = low|Overall survival (OS) is compared between low and high SUVmax groups.||1.20|0.12|0.10
74024806|NCT00265941|147601971|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.04|TWO_SIDED|95.0|0.1|0.97|||Log Rank|2-sided significance level = 0.05|Reference level = low|Loco-regional control (LRC) is compared between low and high SUVmax groups.||0.97|0.10|0.04
73903705|NCT00744471|147337816|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.74|-0.61||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value, as a covariate, and study site as a random effect.||-0.61|-1.74|<0.001
73903706|NCT00744471|147337816|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.06|-0.92||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.92|-2.06|<0.001
73903707|NCT00744471|147337816|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.17|-1.04||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.04|-2.17|<0.001
73903708|NCT00744471|147337817|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.51|-0.13||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.13|-0.51|0.001
73903709|NCT00744471|147337817|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.64|-0.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.25|-0.64|<0.001
73903710|NCT00744471|147337817|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.28||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.28|-0.66|<0.001
73903711|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.93|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-1.93|<0.001
73903712|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.2||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.20|-2.26|<0.001
73903713|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.85|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.80|-1.85|<0.001
73903714|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.11|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.11|<0.001
73903715|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.57|-1.48||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.48|-2.57|<0.001
73903716|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.5|-1.41||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.41|-2.50|<0.001
73962460|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.64|-0.25|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.25|-0.64|<0.0001
73903717|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.65|-0.53||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.53|-1.65|<0.001
73903718|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.2|-1.08||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.08|-2.20|<0.001
73903719|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.56|-1.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.45|-2.56|<0.001
73903720|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.1|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-2.10|<0.001
73903721|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.46|-1.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.25|-2.46|<0.001
73903722|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.57|-1.37||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.37|-2.57|<0.001
73903723|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.75|-0.56||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.56|-1.75|<0.001
73903724|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.12|-0.92||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.92|-2.12|<0.001
73903725|NCT00744471|147337818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.2|-1.01||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.01|-2.20|<0.001
73903726|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.93|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-1.93|<0.001
73903727|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.2||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.20|-2.26|<0.001
73903728|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.85|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.80|-1.85|<0.001
73903729|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.08|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.08|<0.001
73903730|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.52|-1.46||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.46|-2.52|<0.001
73903731|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.54|-1.48||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.48|-2.54|<0.001
73903732|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.71|-0.63||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.63|-1.71|<0.001
73903733|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.21|-1.12||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.12|-2.21|<0.001
73962461|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.0238|TWO_SIDED|95.0|-0.44|-0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.03|-0.44|0.0238
73962462|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.0011|TWO_SIDED|95.0|-0.55|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.14|-0.55|0.0011
73903734|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.06|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.6|-1.52||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.52|-2.60|<0.001
73903735|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.11|-0.99||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.99|-2.11|<0.001
73903736|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.45|-1.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.32|-2.45|<0.001
73903737|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.82|-1.7||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.70|-2.82|<0.001
73903738|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.82|-0.71||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.71|-1.82|<0.001
74024807|NCT02513940|147601981|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
73903739|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.15|-1.03||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.03|-2.15|<0.001
73903740|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.51|-1.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.40|-2.51|<0.001
73903741|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.85|-0.72||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.72|-1.85|<0.001
73903742|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.58|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.15|-1.01||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.01|-2.15|<0.001
73903743|NCT00744471|147337819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.4|-1.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.27|-2.40|<0.001
73903744|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
73962463|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0064|TWO_SIDED|95.0|-0.51|-0.08|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.08|-0.51|0.0064
73962464|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.11||0.0025|TWO_SIDED|95.0|-0.54|-0.12|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.12|-0.54|0.0025
73903745|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.23|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.23|<0.001
73903746|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
73903747|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.12|-1.08||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.08|-2.12|<0.001
73903748|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.12|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.64|-1.6||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.60|-2.64|<0.001
73903749|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.46|-1.43||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.43|-2.46|<0.001
73903750|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.72|-0.64||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.64|-1.72|<0.001
73903751|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.18|-1.09||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.09|-2.18|<0.001
73903752|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.43|-1.35||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.35|-2.43|<0.001
73903753|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.93|-0.77||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.77|-1.93|<0.001
73962465|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0589|TWO_SIDED|95.0|-0.48|0.01|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.01|-0.48|0.0589
74024808|NCT02513940|147601982|SUPERIORITY|||||||0.001||||||"Pairwise comparisons:~Testosterone vs placebo: p=0.008 Progesterone vs placebo: p=0.73 Testosterone vs progesterone: p=0.0008"|Mixed Models Analysis|||||||0.001
73853463|NCT01942668|147255489|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.018|TWO_SIDED|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.04|-0.43|0.018
73853464|NCT01942668|147255489|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.098||0.096|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.03|-0.36|0.096
73853465|NCT01942668|147255490|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.06||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.||1.06||
73853466|NCT01942668|147255490|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.98||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.||0.98||
73853467|NCT01942668|147255490|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.97||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.||0.97||
73853468|NCT01942668|147255490|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.09||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.||1.09||
73853469|NCT01942668|147255490|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||3.2||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.||3.20||
73853470|NCT01942668|147255491|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.06||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.||1.06||
73853471|NCT01942668|147255491|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.98||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.||0.98||
73903754|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.73|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.31|-1.15||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.15|-2.31|<0.001
73903755|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.47|-1.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.32|-2.47|<0.001
73903756|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.52|-0.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 : ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.40|-1.52|<0.001
73903757|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.91|-0.78||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.78|-1.91|<0.001
73903758|NCT00744471|147337820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.09|-0.97||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.97|-2.09|<0.001
73903759|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
74024809|NCT02513940|147601983|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|Repeated measures ANOVA||||||0.60
74024810|NCT02513940|147601984|SUPERIORITY|||||||0.0003||||||"Pairwise comparisons:~Testosterone vs placebo: p = 0.0001 Progesterone vs placebo: p = 0.25 Testosterone vs progesterone: p = 0.002"|Mixed Models Analysis|Repeated measures ANOVA||||||0.0003
73903760|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.23|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.23|<0.001
73903761|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
73903762|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.1|-1.08|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.08|-2.10|<0.001
73903763|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.61|-1.59||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.59|-2.61|<0.001
73903764|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.51|-1.49||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.49|-2.51|<0.001
73903765|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.83|-0.76||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.76|-1.83|<0.001
73903766|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.26|<0.001
73903767|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.53|-1.46||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.46|-2.53|<0.001
73903768|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.11|-1.0||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.00|-2.11|<0.001
73903769|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.93|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.49|-1.37||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.37|-2.49|<0.001
73903770|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.83|-1.72||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.72|-2.83|<0.001
73903771|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.87|-0.75||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.75|-1.87|<0.001
73903772|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.58|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.14|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.02|-2.14|<0.001
73903773|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.47|-1.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.36|-2.47|<0.001
73903774|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.86|-0.74||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.74|-1.86|<0.001
73903775|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.17|-1.05||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.05|-2.17|<0.001
73903776|NCT00744471|147337821|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.91|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.47|-1.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.36|-2.47|<0.001
73903777|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.18||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
73903778|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.83|-0.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.45|-0.83|<0.001
73903779|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
74024811|NCT02513940|147601985|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Fatigue||||>0.99
73903780|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.65|<0.001
73903781|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.88|-0.5||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.50|-0.88|<0.001
73903782|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.73|-0.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.36|-0.73|<0.001
74024812|NCT02513940|147601985|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Rash at gel application site||||>0.99
73853472|NCT01942668|147255491|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.97||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.||0.97||
73853473|NCT01942668|147255491|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.09||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.||1.09||
73853474|NCT01942668|147255491|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||3.2||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.||3.20||
73853475|NCT01942668|147255492|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|2.51||0.588|TWO_SIDED|95.0|-3.57|6.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.30|-3.57|0.588
73853476|NCT01942668|147255492|SUPERIORITY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|2.47||0.601|TWO_SIDED|95.0|-3.56|6.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.15|-3.56|0.601
73853477|NCT01942668|147255492|SUPERIORITY||Mean Difference (Final Values)|3.17|STANDARD_ERROR_OF_MEAN|2.49||0.202|TWO_SIDED|95.0|-1.71|8.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||8.06|-1.71|0.202
73853478|NCT01942668|147255492|SUPERIORITY||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.46||0.431|TWO_SIDED|95.0|-6.76|2.89||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.89|-6.76|0.431
73853479|NCT01942668|147255493|SUPERIORITY||Mean Difference (Final Values)|-4.35|STANDARD_ERROR_OF_MEAN|3.05||0.154|TWO_SIDED|95.0|-10.34|1.64||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.64|-10.34|0.154
73853480|NCT01942668|147255493|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|3.0||0.956|TWO_SIDED|95.0|-6.06|5.73||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||5.73|-6.06|0.956
73853481|NCT01942668|147255493|SUPERIORITY||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|3.01||0.24|TWO_SIDED|95.0|-2.37|9.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||9.46|-2.37|0.240
73903783|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.054|TWO_SIDED|95.0|-0.39|0.0||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||0.00|-0.39|0.054
73903784|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.68|-0.29||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.29|-0.68|<0.001
73903785|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.26||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.26|-0.65|<0.001
73903786|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.15||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.15|-0.55|<0.001
73903787|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.81|-0.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.40|-0.81|<0.001
74088282|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-6.97|STANDARD_ERROR_OF_MEAN|1.77|<|0.0001|TWO_SIDED|95.0|-10.44|-3.51|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-3.51|-10.44|<.0001
74024813|NCT03617926|147601996|SUPERIORITY|In case superiority is not proven, non-inferiority is tested. As non-inferiority margin (δ), a 7.5% worse cure rate is regarded as clinically not relevant. The following null hypothesis will be used: H0, NI: pT-pR \< δ, whereby δ = -7.5%. The lower, 95% confidence interval of the difference pT-pR will be used for the test. If H0, NI will be rejected, non-inferiority cannot be shown.||||||0.023||||||A priori treshold p value of 0.05 for statistical significance was set prior to study start.|Chi-squared|||"Efficacy analyses is performed on the ITT population (all subjects who were included and randomized in the study, with available baseline value of the primary endpoint and at least one follow-up visit). All statistical tests are performed at a 5% level of significance. The aim of this analysis is to show superiority for the cure rate of the test product versus a predefined limit of 70%. The following null hypothesis will be tested: H0, prim: pT - pR = 0 and Ha: pT - pR \> 15%~I"||||0.023
74084895|NCT02174276|147723317|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.017||||0.805|TWO_SIDED|95.0|-0.155|0.12|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.120|-0.155|0.805
73903788|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.73|-0.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.32|-0.73|<0.001
73903789|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|-0.45|-0.07||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.07|-0.45|0.008
73903790|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
73903791|NCT00744471|147337822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|95.0|-0.43|-0.05||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.05|-0.43|0.012
73903792|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.18||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
73903793|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.83|-0.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.45|-0.83|<0.001
74024814|NCT03584009|147602082|SUPERIORITY||Risk Difference (RD)|-1.96||||0.7286|TWO_SIDED|95.0|-16.86|12.94||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Cochran-Mantel-Haenszel|||||12.94|-16.86|0.7286
74024815|NCT03584009|147602083|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.7853|TWO_SIDED|95.0|0.61|1.45||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Regression, Cox|||||1.45|0.61|0.7853
73903794|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
73903795|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.65|<0.001
73903796|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.87|-0.5||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.50|-0.87|<0.001
73903797|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.76|-0.39||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.39|-0.76|<0.001
73903798|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.43|-0.03||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.03|-0.43|0.022
73903799|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.67|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.67|<0.001
73903800|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.26||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.26|-0.65|<0.001
74024816|NCT03584009|147602084|SUPERIORITY||Risk Difference (RD)|-1.96||||0.5978|TWO_SIDED|95.0|-12.29|8.37||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Cochran-Mantel-Haenszel|||||8.37|-12.29|0.5978
74024817|NCT03584009|147602086|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.0403|TWO_SIDED|95.0|1.02|3.43||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Log Rank||Hazard ratios were estimated by Cox regression.|||3.43|1.02|0.0403
73853482|NCT01942668|147255493|SUPERIORITY||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|2.98||0.353|TWO_SIDED|95.0|-8.62|3.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.08|-8.62|0.353
73853483|NCT01942668|147255494|SUPERIORITY||Mean Difference (Final Values)|-8.56|STANDARD_ERROR_OF_MEAN|3.16||0.007|TWO_SIDED|95.0|-14.75|-2.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-2.36|-14.75|0.007
73853484|NCT01942668|147255494|SUPERIORITY||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|3.11||0.227|TWO_SIDED|95.0|-9.86|2.35||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.35|-9.86|0.227
73853485|NCT01942668|147255494|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|3.12||0.597|TWO_SIDED|95.0|-7.77|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||4.47|-7.77|0.597
73853486|NCT01942668|147255494|SUPERIORITY||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|3.08||0.019|TWO_SIDED|95.0|-13.28|-1.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.19|-13.28|0.019
73853487|NCT01942668|147255495|SUPERIORITY||Mean Difference (Final Values)|-12.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.32|-19.29|<0.001
73853488|NCT01942668|147255495|SUPERIORITY||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|3.25||0.013|TWO_SIDED|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.68|-14.46|0.013
73853489|NCT01942668|147255495|SUPERIORITY||Mean Difference (Final Values)|-4.81|STANDARD_ERROR_OF_MEAN|3.26||0.141|TWO_SIDED|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.59|-11.21|0.141
73853490|NCT01942668|147255495|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.22||0.001|TWO_SIDED|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.08|-16.73|0.001
73853491|NCT01942668|147255496|SUPERIORITY||Mean Difference (Final Values)|-15.59|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|-22.16|-9.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.02|-22.16|<0.001
73853492|NCT01942668|147255496|SUPERIORITY||Mean Difference (Final Values)|-9.88|STANDARD_ERROR_OF_MEAN|3.29||0.003|TWO_SIDED|95.0|-16.34|-3.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.41|-16.34|0.003
73853493|NCT01942668|147255496|SUPERIORITY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|3.31||0.075|TWO_SIDED|95.0|-12.4|0.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.59|-12.40|0.075
73853494|NCT01942668|147255496|SUPERIORITY||Mean Difference (Final Values)|-12.05|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|-18.47|-5.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.64|-18.47|<0.001
73853495|NCT01942668|147255497|SUPERIORITY||Mean Difference (Final Values)|-17.87|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-24.57|-11.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.05|-24.57|<0.001
73853496|NCT01942668|147255497|SUPERIORITY||Mean Difference (Final Values)|-11.35|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-18.0|-4.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.70|-18.00|<0.001
73853497|NCT01942668|147255497|SUPERIORITY||Mean Difference (Final Values)|-7.82|STANDARD_ERROR_OF_MEAN|3.4||0.022|TWO_SIDED|95.0|-14.5|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.14|-14.50|0.022
73853498|NCT01942668|147255497|SUPERIORITY||Mean Difference (Final Values)|-12.51|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-19.11|-5.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.91|-19.11|<0.001
73903801|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.19|-0.60|<0.001
73903802|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.88|-0.47||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.47|-0.88|<0.001
73903803|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.79|-0.39||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.39|-0.79|<0.001
74024818|NCT02886715|147602093|EQUIVALENCE|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.75|||||TWO_SIDED|90.0|94.39|103.31||p-value was no calculated|ANOVA|with treatment and site as fixed effects in the model||||103.31|94.39|
73853499|NCT01942668|147255498|SUPERIORITY||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-24.45|-11.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.06|-24.45|<0.001
73853500|NCT01942668|147255498|SUPERIORITY||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-19.88|-6.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.70|-19.88|<0.001
73853501|NCT01942668|147255498|SUPERIORITY||Mean Difference (Final Values)|-10.22|STANDARD_ERROR_OF_MEAN|3.37||0.003|TWO_SIDED|95.0|-16.83|-3.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.60|-16.83|0.003
73853502|NCT01942668|147255498|SUPERIORITY||Mean Difference (Final Values)|-13.61|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-20.15|-7.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.07|-20.15|<0.001
73853503|NCT01942668|147255499|SUPERIORITY||Mean Difference (Final Values)|-16.63|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-23.35|-9.91||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.91|-23.35|<0.001
73853504|NCT01942668|147255499|SUPERIORITY||Mean Difference (Final Values)|-12.97|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-19.58|-6.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.36|-19.58|<0.001
73853505|NCT01942668|147255499|SUPERIORITY||Mean Difference (Final Values)|-9.63|STANDARD_ERROR_OF_MEAN|3.38||0.005|TWO_SIDED|95.0|-16.27|-2.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-2.99|-16.27|0.005
73853506|NCT01942668|147255499|SUPERIORITY||Mean Difference (Final Values)|-11.97|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-18.53|-5.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.41|-18.53|<0.001
73903804|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.14||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.14|-0.53|<0.001
73903805|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.68|-0.28||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.28|-0.68|<0.001
73903806|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.71|-0.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.32|-0.71|<0.001
74088283|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-3.08|STANDARD_ERROR_OF_MEAN|1.87||0.1004|TWO_SIDED|95.0|-6.76|0.6|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.60|-6.76|0.1004
73853507|NCT01942668|147255500|SUPERIORITY||Mean Difference (Final Values)|-17.12|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-23.79|-10.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.44|-23.79|<0.001
73853508|NCT01942668|147255500|SUPERIORITY||Mean Difference (Final Values)|-15.58|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-22.15|-9.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.01|-22.15|<0.001
73853509|NCT01942668|147255500|SUPERIORITY||Mean Difference (Final Values)|-11.05|STANDARD_ERROR_OF_MEAN|3.36||0.001|TWO_SIDED|95.0|-17.65|-4.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.44|-17.65|0.001
73853510|NCT01942668|147255500|SUPERIORITY||Mean Difference (Final Values)|-13.02|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-19.54|-6.5||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.50|-19.54|<0.001
73903807|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.01|TWO_SIDED|95.0|-0.47|-0.06||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.06|-0.47|0.010
73903808|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.25|-0.66|<0.001
73903809|NCT00744471|147337823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.53|-0.13||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.13|-0.53|0.001
73903810|NCT03070444|147337866|OTHER|GEE analysis|GEE analysis|0.99||||0.0002|TWO_SIDED|95.0|0.48|1.51|||GEE analysis|||||1.51|0.48|0.0002
73903811|NCT03070444|147337867|OTHER|Mann-Whitney U test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
73903812|NCT02582255|147337877|OTHER|||||||0.05|||||||Clopper-Pearson|||||||0.05
73903813|NCT02582255|147337878|OTHER|||||||0.025|||||||Clopper-Pearson|||||||0.025
73903814|NCT02582255|147337879|OTHER|||||||0.025|||||||Clopper-Pearson|||||||0.025
73903815|NCT02582255|147337880|OTHER|||||||0.05|||||||Clopper-Pearson|||||||0.05
74024819|NCT02886715|147602093|SUPERIORITY||Mean Difference (Final Values)|-5.17||||0.0185|TWO_SIDED|95.0|-9.46|-0.87|||ANOVA|with treatment and site as fixed effects in the model||||-0.87|-9.46|0.0185
73853511|NCT01942668|147255501|SUPERIORITY||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|3.45|<|0.001|TWO_SIDED|95.0|-23.58|-10.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.03|-23.58|<0.001
73853512|NCT01942668|147255501|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-22.32|-8.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.99|-22.32|<0.001
73853513|NCT01942668|147255501|SUPERIORITY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|3.41||0.001|TWO_SIDED|95.0|-17.9|-4.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.49|-17.90|0.001
73853514|NCT01942668|147255501|SUPERIORITY||Mean Difference (Final Values)|-12.16|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-18.78|-5.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.55|-18.78|<0.001
73853515|NCT01942668|147255502|SUPERIORITY||Mean Difference (Final Values)|-18.11|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|-24.92|-11.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.29|-24.92|<0.001
73853516|NCT01942668|147255502|SUPERIORITY||Mean Difference (Final Values)|-16.45|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-23.17|-9.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.74|-23.17|<0.001
73853517|NCT01942668|147255502|SUPERIORITY||Mean Difference (Final Values)|-12.41|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-19.15|-5.66||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.66|-19.15|<0.001
73853518|NCT01942668|147255502|SUPERIORITY||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-20.26|-6.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.93|-20.26|<0.001
73903816|NCT02417844|147337884|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.66|STANDARD_DEVIATION|19.15|||TWO_SIDED|90.0|92.19|107.74|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||107.74|92.19|
73903817|NCT02417844|147337885|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.58|STANDARD_DEVIATION|13.51|||TWO_SIDED|90.0|94.23|105.24|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||105.24|94.23|
73903818|NCT02417844|147337886|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.48|STANDARD_DEVIATION|14.12|||TWO_SIDED|90.0|93.9|105.39|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||105.39|93.90|
73853519|NCT01942668|147255503|SUPERIORITY||Mean Difference (Final Values)|-16.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.82|-23.33|<0.001
73853520|NCT01942668|147255503|SUPERIORITY||Mean Difference (Final Values)|-15.07|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.42|-21.72|<0.001
73853521|NCT01942668|147255503|SUPERIORITY||Mean Difference (Final Values)|-10.79|STANDARD_ERROR_OF_MEAN|3.41||0.002|TWO_SIDED|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.10|-17.48|0.002
73903819|NCT00749580|147337912|SUPERIORITY_OR_OTHER|||||||0.935|||||||Fisher Exact|||||||0.935
73903820|NCT00054717|147337918|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903821|NCT00054717|147337919|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
73903822|NCT00054717|147337920|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903823|NCT00054717|147337921|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903824|NCT00054717|147337922|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903825|NCT00054717|147337923|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903826|NCT00054717|147337924|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903827|NCT00054717|147337925|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903828|NCT00054717|147337926|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
74024820|NCT02886715|147602095|EQUIVALENCE|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.39|||||TWO_SIDED|90.0|93.42|103.61||p-value was no calculated|ANOVA|with treatment and site as fixed effects in the model||||103.61|93.42|
73853522|NCT01942668|147255503|SUPERIORITY||Mean Difference (Final Values)|-11.71|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.11|-18.31|<0.001
73853523|NCT01942668|147255504|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.034||0.801|TWO_SIDED|95.0|-0.06|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.06|0.801
73853524|NCT01942668|147255504|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.034||0.991|TWO_SIDED|95.0|-0.07|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.07|0.991
73853525|NCT01942668|147255504|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.034||0.642|TWO_SIDED|95.0|-0.05|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.05|0.642
73853526|NCT01942668|147255504|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.034||0.928|TWO_SIDED|95.0|-0.07|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.06|-0.07|0.928
73853527|NCT01942668|147255505|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.043||0.231|TWO_SIDED|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.14|0.231
73853528|NCT01942668|147255505|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.042||0.173|TWO_SIDED|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.14|0.173
73853529|NCT01942668|147255505|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.042||0.717|TWO_SIDED|95.0|-0.07|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.07|0.717
73853530|NCT01942668|147255505|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.042||0.849|TWO_SIDED|95.0|-0.09|0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.09|0.849
73853531|NCT01942668|147255506|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.039|TWO_SIDED|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.21|0.039
73853532|NCT01942668|147255506|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.03|TWO_SIDED|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.21|0.030
73853533|NCT01942668|147255506|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.052||0.946|TWO_SIDED|95.0|-0.1|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.10|0.946
73853534|NCT01942668|147255506|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.051||0.309|TWO_SIDED|95.0|-0.15|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.05|-0.15|0.309
73853535|NCT01942668|147255507|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.061||0.031|TWO_SIDED|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.25|0.031
73853536|NCT01942668|147255507|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.005|TWO_SIDED|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.05|-0.28|0.005
73853537|NCT01942668|147255507|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.401|TWO_SIDED|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.17|0.401
73853538|NCT01942668|147255507|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.059||0.1|TWO_SIDED|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.21|0.100
73853539|NCT01942668|147255508|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.071||0.001|TWO_SIDED|95.0|-0.37|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.37|0.001
73853540|NCT01942668|147255508|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.034|TWO_SIDED|95.0|-0.28|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.28|0.034
73853541|NCT01942668|147255508|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.79|TWO_SIDED|95.0|-0.16|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.12|-0.16|0.790
73853542|NCT01942668|147255508|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.069||0.086|TWO_SIDED|95.0|-0.25|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.25|0.086
73903829|NCT00054717|147337927|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73853543|NCT01942668|147255509|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.53|<0.001
73853544|NCT01942668|147255509|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.083||0.03|TWO_SIDED|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.34|0.030
73853545|NCT01942668|147255509|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.083||0.247|TWO_SIDED|95.0|-0.26|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.26|0.247
73853546|NCT01942668|147255509|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.082||0.022|TWO_SIDED|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.35|0.022
73853547|NCT01942668|147255510|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.54|<0.001
73853548|NCT01942668|147255510|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.083||0.002|TWO_SIDED|95.0|-0.42|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.42|0.002
73853549|NCT01942668|147255510|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.084||0.031|TWO_SIDED|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.34|0.031
73853550|NCT01942668|147255510|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.083||0.016|TWO_SIDED|95.0|-0.36|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.36|0.016
73853551|NCT01942668|147255511|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.21|-0.55|<0.001
73853552|NCT01942668|147255511|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.086||0.008|TWO_SIDED|95.0|-0.4|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.40|0.008
73853553|NCT01942668|147255511|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.086||0.087|TWO_SIDED|95.0|-0.32|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.32|0.087
73853554|NCT01942668|147255511|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.085||0.092|TWO_SIDED|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.31|0.092
73853555|NCT01942668|147255512|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.092|<|0.001|TWO_SIDED|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.30|-0.66|<0.001
73853556|NCT01942668|147255512|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.09||0.001|TWO_SIDED|95.0|-0.47|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.12|-0.47|0.001
73853557|NCT01942668|147255512|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.091||0.009|TWO_SIDED|95.0|-0.42|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.42|0.009
73853558|NCT01942668|147255512|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.007|TWO_SIDED|95.0|-0.42|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.42|0.007
73853559|NCT01942668|147255513|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.33|-0.71|<0.001
73853560|NCT01942668|147255513|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.094||0.003|TWO_SIDED|95.0|-0.46|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.46|0.003
73853561|NCT01942668|147255513|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.095||0.016|TWO_SIDED|95.0|-0.41|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.41|0.016
73853562|NCT01942668|147255513|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.094||0.31|TWO_SIDED|95.0|-0.28|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.28|0.310
73853563|NCT01942668|147255514|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.34|-0.72|<0.001
73853564|NCT01942668|147255514|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.56|-0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.19|-0.56|<0.001
73962466|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.018|TWO_SIDED|95.0|-0.53|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.05|-0.53|0.0180
73853565|NCT01942668|147255514|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.097||0.011|TWO_SIDED|95.0|-0.44|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.44|0.011
74024821|NCT02886715|147602095|SUPERIORITY||Mean Difference (Final Values)|-4.39||||0.0354|TWO_SIDED|95.0|-8.48|-0.3|||ANOVA|with treatment and site as fixed effects in the model||||-0.30|-8.48|0.0354
74024822|NCT01073943|147602138|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was \>-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was \>0%.|Mean Difference (Net)|3.3|||||ONE_SIDED|97.5|-2.9||||||||||-2.9|
73853566|NCT01942668|147255514|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.076|TWO_SIDED|95.0|-0.36|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.36|0.076
73853567|NCT01942668|147255515|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.38|-0.77|<0.001
73853568|NCT01942668|147255515|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.59|<0.001
73853569|NCT01942668|147255515|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.018|TWO_SIDED|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.43|0.018
73853570|NCT01942668|147255515|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.098||0.096|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.36|0.096
73853571|NCT01942668|147255516|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|2.88||0.865|TWO_SIDED|95.0|-5.16|6.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.14|-5.16|0.865
73853572|NCT01942668|147255516|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|2.83||0.847|TWO_SIDED|95.0|-5.01|6.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.10|-5.01|0.847
73853573|NCT01942668|147255516|SUPERIORITY||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|2.85||0.463|TWO_SIDED|95.0|-3.5|7.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||7.68|-3.50|0.463
73853574|NCT01942668|147255516|SUPERIORITY||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|2.81||0.207|TWO_SIDED|95.0|-9.07|1.97||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.97|-9.07|0.207
74024823|NCT01073943|147602139|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|-2.7|||||ONE_SIDED|97.5|-8.8||||||||||-8.8|
73853575|NCT01942668|147255517|SUPERIORITY||Mean Difference (Final Values)|-5.07|STANDARD_ERROR_OF_MEAN|3.43||0.14|TWO_SIDED|95.0|-11.8|1.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.67|-11.80|0.140
73853576|NCT01942668|147255517|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|3.38||0.982|TWO_SIDED|95.0|-6.7|6.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.55|-6.70|0.982
73853577|NCT01942668|147255517|SUPERIORITY||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|3.39||0.492|TWO_SIDED|95.0|-4.32|8.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||8.98|-4.32|0.492
73853578|NCT01942668|147255517|SUPERIORITY||Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|3.35||0.216|TWO_SIDED|95.0|-10.72|2.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.43|-10.72|0.216
73853579|NCT01942668|147255518|SUPERIORITY||Mean Difference (Final Values)|-10.38|STANDARD_ERROR_OF_MEAN|3.5||0.003|TWO_SIDED|95.0|-17.26|-3.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.50|-17.26|0.003
74024824|NCT01073943|147602140|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74024825|NCT01073943|147602141|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
74024826|NCT01073943|147602142|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74024827|NCT01073943|147602143|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74024828|NCT01073943|147602144|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
74024829|NCT01073943|147602145|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
74024830|NCT01073943|147602147|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|4.5|||||ONE_SIDED|97.5|-0.1|||||||Mid colon comparison|||-0.1|
74024831|NCT01073943|147602147|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|3.2|||||ONE_SIDED|97.5|-1.5|||||||Recto-sigmoid colon comparison|||-1.5|
74024832|NCT01073943|147602147|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|0.9|||||ONE_SIDED|97.5|-5.7|||||||Overall comparison: ascending colon, mid colon and recto-sigmoid colon|||-5.7|
74024833|NCT04871815|147602169|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Body Aches||||0.200
73853580|NCT01942668|147255518|SUPERIORITY||Mean Difference (Final Values)|-3.75|STANDARD_ERROR_OF_MEAN|3.45||0.277|TWO_SIDED|95.0|-10.53|3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.02|-10.53|0.277
73853581|NCT01942668|147255518|SUPERIORITY||Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|3.46||0.394|TWO_SIDED|95.0|-9.75|3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.84|-9.75|0.394
74024834|NCT04871815|147602169|SUPERIORITY|||||||0.0326|||||||Wilcoxon (Mann-Whitney)|||Headaches||||0.0326
73853582|NCT01942668|147255518|SUPERIORITY||Mean Difference (Final Values)|-7.86|STANDARD_ERROR_OF_MEAN|3.42||0.022|TWO_SIDED|95.0|-14.58|-1.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.15|-14.58|0.022
73853583|NCT01942668|147255519|SUPERIORITY||Mean Difference (Final Values)|-15.32|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-22.75|-7.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.89|-22.75|<0.001
74024835|NCT04871815|147602169|SUPERIORITY|||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||Coughing/Sneezing||||0.0043
74084896|NCT02174276|147723317|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|0.063||||0.37|TWO_SIDED|95.0|-0.075|0.202|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.202|-0.075|0.370
73853584|NCT01942668|147255519|SUPERIORITY||Mean Difference (Final Values)|-8.92|STANDARD_ERROR_OF_MEAN|3.73||0.017|TWO_SIDED|95.0|-16.24|-1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.60|-16.24|0.017
73903830|NCT00054717|147337928|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903831|NCT00054717|147337929|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
74024836|NCT04871815|147602169|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Trouble Breathing||||0.0003
73853585|NCT01942668|147255519|SUPERIORITY||Mean Difference (Final Values)|-4.56|STANDARD_ERROR_OF_MEAN|3.74||0.223|TWO_SIDED|95.0|-11.9|2.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.78|-11.90|0.223
73903832|NCT00054717|147337930|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903833|NCT00054717|147337931|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903834|NCT00054717|147337932|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903835|NCT00054717|147337933|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903836|NCT00054717|147337934|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
73903837|NCT00054717|147337935|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
73903838|NCT00054717|147337936|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
73903839|NCT00054717|147337937|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
74024837|NCT04871815|147602169|SUPERIORITY|||||||0.3714|||||||Wilcoxon (Mann-Whitney)|||Congestion||||0.3714
74024838|NCT04871815|147602169|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Fatigue||||0.300
74024839|NCT04871815|147602169|SUPERIORITY|||||||0.2286|||||||Wilcoxon (Mann-Whitney)|||Loss of Smell/Taste||||0.2286
74024840|NCT04871815|147602169|SUPERIORITY|||||||0.999|||||||Wilcoxon (Mann-Whitney)|||Anxiety||||0.999
74024841|NCT04871815|147602170|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74024842|NCT04871815|147602171|SUPERIORITY|||||||0.1963|||||||ANOVA|||||||0.1963
74024843|NCT04871815|147602172|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
74024844|NCT04871815|147602172|SUPERIORITY|||||||0.0008||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 1 baseline (day 1 of study) vs Day 1 treatment (day 7 of study).||||0.0008
73853586|NCT01942668|147255519|SUPERIORITY||Mean Difference (Final Values)|-11.32|STANDARD_ERROR_OF_MEAN|3.69||0.002|TWO_SIDED|95.0|-18.57|-4.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.07|-18.57|0.002
73853587|NCT01942668|147255520|SUPERIORITY||Mean Difference (Final Values)|-17.47|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-24.65|-10.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.28|-24.65|<0.001
73853588|NCT01942668|147255520|SUPERIORITY||Mean Difference (Final Values)|-10.26|STANDARD_ERROR_OF_MEAN|3.6||0.005|TWO_SIDED|95.0|-17.33|-3.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.18|-17.33|0.005
73853589|NCT01942668|147255520|SUPERIORITY||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|3.62||0.087|TWO_SIDED|95.0|-13.31|0.89||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.89|-13.31|0.087
73853590|NCT01942668|147255520|SUPERIORITY||Mean Difference (Final Values)|-12.66|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-19.68|-5.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.65|-19.68|<0.001
73853591|NCT01942668|147255521|SUPERIORITY||Mean Difference (Final Values)|-20.32|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-27.77|-12.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.87|-27.77|<0.001
73853592|NCT01942668|147255521|SUPERIORITY||Mean Difference (Final Values)|-12.61|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-19.95|-5.28||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.28|-19.95|<0.001
73853593|NCT01942668|147255521|SUPERIORITY||Mean Difference (Final Values)|-8.33|STANDARD_ERROR_OF_MEAN|3.75||0.027|TWO_SIDED|95.0|-15.7|-0.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.96|-15.70|0.027
73853594|NCT01942668|147255521|SUPERIORITY||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-21.13|-6.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.58|-21.13|<0.001
73853595|NCT01942668|147255522|SUPERIORITY||Mean Difference (Final Values)|-21.45|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-28.87|-14.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-14.04|-28.87|<0.001
73853596|NCT01942668|147255522|SUPERIORITY||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-23.39|-8.8||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.80|-23.39|<0.001
73853597|NCT01942668|147255522|SUPERIORITY||Mean Difference (Final Values)|-12.01|STANDARD_ERROR_OF_MEAN|3.73||0.001|TWO_SIDED|95.0|-19.34|-4.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.68|-19.34|0.001
73853598|NCT01942668|147255522|SUPERIORITY||Mean Difference (Final Values)|-15.73|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-22.97|-8.49||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.49|-22.97|<0.001
73853599|NCT01942668|147255523|SUPERIORITY||Mean Difference (Final Values)|-20.52|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-28.06|-12.97||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.97|-28.06|<0.001
73853600|NCT01942668|147255523|SUPERIORITY||Mean Difference (Final Values)|-15.37|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-22.8|-7.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.95|-22.80|<0.001
73853601|NCT01942668|147255523|SUPERIORITY||Mean Difference (Final Values)|-11.49|STANDARD_ERROR_OF_MEAN|3.8||0.003|TWO_SIDED|95.0|-18.95|-4.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.03|-18.95|0.003
73853602|NCT01942668|147255523|SUPERIORITY||Mean Difference (Final Values)|-13.82|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-21.19|-6.46||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.46|-21.19|<0.001
73853603|NCT01942668|147255524|SUPERIORITY||Mean Difference (Final Values)|-20.34|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-27.93|-12.74||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.74|-27.93|<0.001
73853604|NCT01942668|147255524|SUPERIORITY||Mean Difference (Final Values)|-17.92|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-25.39|-10.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.45|-25.39|<0.001
73853605|NCT01942668|147255524|SUPERIORITY||Mean Difference (Final Values)|-12.97|STANDARD_ERROR_OF_MEAN|3.82|<|0.001|TWO_SIDED|95.0|-20.49|-5.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.46|-20.49|<0.001
73853606|NCT01942668|147255524|SUPERIORITY||Mean Difference (Final Values)|-14.28|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-21.7|-6.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.87|-21.70|<0.001
73903840|NCT00054717|147337977|SUPERIORITY_OR_OTHER|||||||0.9894||95.0|||||Log Rank|||||||0.9894
73853607|NCT01942668|147255525|SUPERIORITY||Mean Difference (Final Values)|-21.01|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-28.72|-13.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-13.29|-28.72|<0.001
73903841|NCT04626310|147338075|SUPERIORITY||Linear slope difference DBT-ER-IP|0.096|STANDARD_ERROR_OF_MEAN|0.08||0.8|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.8
74024845|NCT04871815|147602172|SUPERIORITY||||||<|0.0001||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 1 baseline (day 1 of study) vs Day 7 treatment (day 14 of study).||||<0.0001
73853608|NCT01942668|147255525|SUPERIORITY||Mean Difference (Final Values)|-18.37|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-25.96|-10.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.78|-25.96|<0.001
73853609|NCT01942668|147255525|SUPERIORITY||Mean Difference (Final Values)|-13.03|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-20.66|-5.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.39|-20.66|<0.001
73853610|NCT01942668|147255525|SUPERIORITY||Mean Difference (Final Values)|-14.65|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-22.19|-7.12||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.12|-22.19|<0.001
73853611|NCT01942668|147255526|SUPERIORITY||Mean Difference (Final Values)|-21.83|STANDARD_ERROR_OF_MEAN|3.94|<|0.001|TWO_SIDED|95.0|-29.57|-14.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-14.08|-29.57|<0.001
73853612|NCT01942668|147255526|SUPERIORITY||Mean Difference (Final Values)|-19.4|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-27.02|-11.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.77|-27.02|<0.001
73853613|NCT01942668|147255526|SUPERIORITY||Mean Difference (Final Values)|-13.98|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-21.65|-6.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.32|-21.65|<0.001
73853614|NCT01942668|147255526|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|3.85|<|0.001|TWO_SIDED|95.0|-23.23|-8.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.10|-23.23|<0.001
73853615|NCT01942668|147255527|SUPERIORITY||Mean Difference (Final Values)|-20.61|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-28.32|-12.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.89|-28.32|<0.001
73853616|NCT01942668|147255527|SUPERIORITY||Mean Difference (Final Values)|-18.24|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-25.84|-10.65||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.65|-25.84|<0.001
73853617|NCT01942668|147255527|SUPERIORITY||Mean Difference (Final Values)|-12.62|STANDARD_ERROR_OF_MEAN|3.89||0.001|TWO_SIDED|95.0|-20.26|-4.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.98|-20.26|0.001
73853618|NCT01942668|147255527|SUPERIORITY||Mean Difference (Final Values)|-13.97|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-21.51|-6.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.43|-21.51|<0.001
73853619|NCT01942668|147255528|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.027||0.676|TWO_SIDED|95.0|-0.04|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.04|0.676
73853620|NCT01942668|147255528|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.027||0.436|TWO_SIDED|95.0|-0.03|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.03|0.436
73853621|NCT01942668|147255528|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.027||0.106|TWO_SIDED|95.0|-0.01|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.01|0.106
73853622|NCT01942668|147255528|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.027||0.752|TWO_SIDED|95.0|-0.06|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.06|0.752
73853623|NCT01942668|147255529|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.038||0.193|TWO_SIDED|95.0|-0.12|0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.12|0.193
73903842|NCT04626310|147338075|SUPERIORITY||Linear Slope difference DBT-IE-IP|-0.234|STANDARD_ERROR_OF_MEAN|0.385||0.544|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.544
73903843|NCT04626310|147338075|SUPERIORITY||Linear Slope difference DBT-ER-DBT-IE|0.329|STANDARD_ERROR_OF_MEAN|0.429||0.442|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.442
74024846|NCT04871815|147602172|SUPERIORITY|||||||0.0114||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 7 baseline (day 7 of study) vs Day 1 treatment (day 7 of study).||||0.0114
73853624|NCT01942668|147255529|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.037||0.319|TWO_SIDED|95.0|-0.11|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.11|0.319
74024847|NCT04871815|147602172|SUPERIORITY||||||<|0.0001||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day7 baseline (day 7 of study) vs Day 7 treatment (day 14 of study)||||<0.0001
73853625|NCT01942668|147255529|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.037||0.239|TWO_SIDED|95.0|-0.03|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.12|-0.03|0.239
73853626|NCT01942668|147255529|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.72|TWO_SIDED|95.0|-0.09|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.06|-0.09|0.720
73853627|NCT01942668|147255530|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.049||0.03|TWO_SIDED|95.0|-0.2|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.20|0.030
73853628|NCT01942668|147255530|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.048||0.06|TWO_SIDED|95.0|-0.19|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.00|-0.19|0.060
73853629|NCT01942668|147255530|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.048||0.506|TWO_SIDED|95.0|-0.06|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.13|-0.06|0.506
73853630|NCT01942668|147255530|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.048||0.232|TWO_SIDED|95.0|-0.15|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.15|0.232
73853631|NCT01942668|147255531|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.058||0.027|TWO_SIDED|95.0|-0.24|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.24|0.027
73853632|NCT01942668|147255531|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.057||0.011|TWO_SIDED|95.0|-0.26|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.26|0.011
73853633|NCT01942668|147255531|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.057||0.71|TWO_SIDED|95.0|-0.13|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.13|0.710
73853634|NCT01942668|147255531|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.057||0.072|TWO_SIDED|95.0|-0.21|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.21|0.072
73853635|NCT01942668|147255532|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.36|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.36|<0.001
73853636|NCT01942668|147255532|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.068||0.062|TWO_SIDED|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.26|0.062
73903844|NCT04626310|147338076|SUPERIORITY||Linear slope difference DBT-ER-IP|1.951|STANDARD_ERROR_OF_MEAN|1.15||0.09|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.09
73903845|NCT04626310|147338076|SUPERIORITY||Linear slope difference DBT-IE-IP|0.1|STANDARD_ERROR_OF_MEAN|1.228||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
73903846|NCT04626310|147338076|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|1.851|STANDARD_ERROR_OF_MEAN|1.103||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
73903847|NCT04626310|147338076|SUPERIORITY||Quad slope difference DBT-ER-IP|-0.028|STANDARD_ERROR_OF_MEAN|0.15||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
74024848|NCT03830281|147602173|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|Mean Difference (Final Values)|0.02||||0.565|TWO_SIDED|95.0|-0.06|0.11|||Mixed Models Analysis|||||0.11|-0.06|0.565
74024849|NCT03830281|147602174|SUPERIORITY||LS Mean Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-36.0|-12.2|||ANCOVA|||||-12.2|-36.0|<0.001
74024850|NCT03830281|147602175|SUPERIORITY||LS Mean Difference|-27.8|||<|0.001|TWO_SIDED|95.0|-42.6|-13.0|||ANCOVA|||||-13.0|-42.6|< 0.001
73853637|NCT01942668|147255532|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.068||0.886|TWO_SIDED|95.0|-0.12|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.14|-0.12|0.886
73853638|NCT01942668|147255532|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.067||0.067|TWO_SIDED|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.26|0.067
74024851|NCT03830281|147602176|SUPERIORITY||LS Mean Difference|0.7||||0.532|TWO_SIDED|95.0|-1.4|2.8|||Mixed Models Analysis|||Statistical analysis during daytime is reported.||2.8|-1.4|0.532
74024852|NCT03830281|147602176|SUPERIORITY||LS Mean Difference|0.4||||0.738|TWO_SIDED|95.0|-1.8|2.5|||Mixed Models Analysis|||Statistical analysis during 24-hour period is reported.||2.5|-1.8|0.738
74024853|NCT00594399|147602188|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of insulin|Mixed Models Analysis|||||||0.43
73853639|NCT01942668|147255533|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.53|<0.001
73853640|NCT01942668|147255533|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.082||0.053|TWO_SIDED|95.0|-0.32|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.00|-0.32|0.053
73853641|NCT01942668|147255533|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.083||0.413|TWO_SIDED|95.0|-0.23|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.23|0.413
73853642|NCT01942668|147255533|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.082||0.018|TWO_SIDED|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.35|0.018
73853643|NCT01942668|147255534|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.54|<0.001
73853644|NCT01942668|147255534|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.083||0.006|TWO_SIDED|95.0|-0.4|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.40|0.006
73853645|NCT01942668|147255534|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.084||0.072|TWO_SIDED|95.0|-0.32|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.32|0.072
73853646|NCT01942668|147255534|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.083||0.014|TWO_SIDED|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.37|0.014
73853647|NCT01942668|147255535|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.21|-0.55|<0.001
73853648|NCT01942668|147255535|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.085||0.016|TWO_SIDED|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.37|0.016
73853649|NCT01942668|147255535|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.086||0.169|TWO_SIDED|95.0|-0.29|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.05|-0.29|0.169
73853650|NCT01942668|147255535|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.085||0.081|TWO_SIDED|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.31|0.081
73853651|NCT01942668|147255536|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.092|<|0.001|TWO_SIDED|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.30|-0.66|<0.001
73853652|NCT01942668|147255536|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.091||0.003|TWO_SIDED|95.0|-0.45|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.10|-0.45|0.003
73853653|NCT01942668|147255536|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.091||0.022|TWO_SIDED|95.0|-0.39|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.39|0.022
73903848|NCT04626310|147338076|SUPERIORITY||Quad slope difference DBT-IE-IP|-0.029|STANDARD_ERROR_OF_MEAN|0.145||0.836|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.836
73903849|NCT04626310|147338076|SUPERIORITY||Quad slope difference DBT-ER-DBT-IE|0.001|STANDARD_ERROR_OF_MEAN|0.145||0.994|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.994
74024854|NCT00594399|147602191|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of glucose|Mixed Models Analysis|||||||0.91
73853654|NCT01942668|147255536|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.006|TWO_SIDED|95.0|-0.43|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.43|0.006
74024855|NCT00594399|147602194|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Omnibus test of difference between groups over time with adjustment for baseline value of physical activity|Mixed Models Analysis|||||||<0.001
74024856|NCT03192904|147602209|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
73853655|NCT01942668|147255537|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.33|-0.71|<0.001
74024857|NCT01309737|147602224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.2|||<|0.0001|TWO_SIDED|95.0|5.33|17.68||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||17.68|5.33|<0.0001
74024858|NCT01309737|147602224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.43|||<|0.0001|TWO_SIDED|95.0|8.99|30.59||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||30.59|8.99|<0.0001
74024859|NCT01309737|147602224|SUPERIORITY_OR_OTHER||Percent difference|13.08|STANDARD_ERROR_OF_MEAN|3.62||0.0003|TWO_SIDED|95.0|5.99|20.17|||Normal approximation|||||20.17|5.99|0.0003
74024860|NCT01309737|147602225|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-45.73|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|-52.98|-38.49||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-38.49|-52.98|<0.0001
74084897|NCT02174276|147723317|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.056||||0.426|TWO_SIDED|95.0|-0.194|0.082|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.082|-0.194|0.426
74084898|NCT00434837|147723353|SUPERIORITY|||||||0.27|||||||ANOVA|||These results are from the 3-year analysis.||||.27
74084899|NCT00434837|147723354|SUPERIORITY|||||||0.08|||||||ANOVA|||These results are from the 7-year analysis.||||.08
74084900|NCT00434837|147723355|SUPERIORITY|||||||0.22|||||||ANOVA|||These results are from the 15-year analysis.||||.22
74084901|NCT00434837|147723356|SUPERIORITY|||||||0.0078|||||||ANOVA|||These results are from the 15-year analysis.||||.0078
74084902|NCT00434837|147723357|SUPERIORITY|||||||0.0018|||||||ANOVA|||These results are from the 15-year analysis.||||.0018
73903850|NCT04626310|147338077|SUPERIORITY||Linear slope difference DBT-ER-IP|0.059|STANDARD_ERROR_OF_MEAN|0.083||0.475|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.475
73903851|NCT04626310|147338077|SUPERIORITY||Linear slope difference DBT-IE-IP|0.037|STANDARD_ERROR_OF_MEAN|0.082||0.654|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.654
73903852|NCT04626310|147338077|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|0.022|STANDARD_ERROR_OF_MEAN|0.085||0.791|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.791
73903853|NCT04626310|147338078|SUPERIORITY||Linear slope difference DBT-ER-IP|-0.332|STANDARD_ERROR_OF_MEAN|0.095||0.001|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.001
74084903|NCT00434837|147723358|SUPERIORITY|||||||0.015|||||||ANOVA|||These results are from the 15-year analysis.||||.015
74084904|NCT00434837|147723359|SUPERIORITY|||||||0.003|||||||ANOVA|||These results are from the 15-year analysis.||||.003
74084905|NCT00434837|147723360|SUPERIORITY|||||||0.0006|||||||ANOVA|||These results are from the 15-year analysis.||||.0006
74084906|NCT00434837|147723361|SUPERIORITY|||||||0.15|||||||ANOVA|||These results are from the 15-year analysis.||||.15
74084907|NCT00434837|147723362|SUPERIORITY|||||||0.34|||||||Chi-squared|||These results are from the 15-year analysis.||||.34
74084908|NCT00434837|147723363|SUPERIORITY|||||||0.17|||||||ANOVA|||These results are from the 15-year analysis.||||.17
74084909|NCT00434837|147723364|SUPERIORITY|||||||0.25|||||||ANOVA|||These results are from the 15-year analysis.||||.25
74084910|NCT00434837|147723365|SUPERIORITY|||||||0.61|||||||ANOVA|||These results are from the 15-year analysis.||||.61
73962467|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.0944|TWO_SIDED|95.0|-0.47|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.04|-0.47|0.0944
73962468|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1198|TWO_SIDED|95.0|-0.45|0.05|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.05|-0.45|0.1198
73962469|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1837|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.43|0.1837
73962470|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.13||0.317|TWO_SIDED|95.0|-0.39|0.13|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.13|-0.39|0.3170
73962471|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1873|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.43|0.1873
73962472|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.5719|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.18|-0.33|0.5719
74084911|NCT00434837|147723366|SUPERIORITY|||||||0.15|||||||ANOVA|||These results are from the 15-year analysis.||||.15
73853656|NCT01942668|147255537|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.095||0.007|TWO_SIDED|95.0|-0.44|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.44|0.007
73853657|NCT01942668|147255537|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.095||0.038|TWO_SIDED|95.0|-0.39|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.39|0.038
73853658|NCT01942668|147255537|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.094||0.283|TWO_SIDED|95.0|-0.29|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.29|0.283
73853659|NCT01942668|147255538|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.34|-0.72|<0.001
73853660|NCT01942668|147255538|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-0.54|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.16|-0.54|<0.001
74084912|NCT00434837|147723367|SUPERIORITY|||||||0.53|||||||ANOVA|||These results are from the 15-year analysis.||||.53
74084913|NCT00434837|147723368|SUPERIORITY|||||||0.82|||||||ANOVA|||These results are from the 15-year analysis.||||.82
74084914|NCT00434837|147723369|SUPERIORITY|||||||0.03|||||||ANOVA|||These results are from the 15-year analysis.||||.03
73853661|NCT01942668|147255538|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.098||0.027|TWO_SIDED|95.0|-0.41|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.41|0.027
73853662|NCT01942668|147255538|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.071|TWO_SIDED|95.0|-0.36|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.36|0.071
73853663|NCT01942668|147255539|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.77|-0.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.37|-0.77|<0.001
73853664|NCT01942668|147255539|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.18|-0.57|<0.001
73853665|NCT01942668|147255539|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.039|TWO_SIDED|95.0|-0.4|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.40|0.039
73853666|NCT01942668|147255539|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.099||0.088|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.36|0.088
74084915|NCT00434837|147723370|SUPERIORITY|||||||0.67|||||||ANOVA|||These results are from the 15-year analysis.||||.67
73853667|NCT01942668|147255540|SUPERIORITY|||||||0.85||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.850
73853668|NCT01942668|147255540|SUPERIORITY|||||||0.622||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.622
73853669|NCT01942668|147255540|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||1.000
73853670|NCT01942668|147255540|SUPERIORITY|||||||0.374||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.374
73853671|NCT01942668|147255540|SUPERIORITY|||||||0.706||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.706
73853672|NCT01942668|147255540|SUPERIORITY|||||||0.372||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.372
73853673|NCT01942668|147255540|SUPERIORITY|||||||0.316||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.316
73853674|NCT01942668|147255540|SUPERIORITY|||||||0.221||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.221
74084916|NCT00434837|147723372|SUPERIORITY|||||||0.051|||||||ANOVA|||These results are from the 15-year analysis.||||.051
73853675|NCT01942668|147255541|SUPERIORITY|||||||0.283||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.283
73853676|NCT01942668|147255541|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.004
73853677|NCT01942668|147255541|SUPERIORITY|||||||0.68||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.680
73853678|NCT01942668|147255541|SUPERIORITY|||||||0.232||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.232
73853679|NCT01942668|147255541|SUPERIORITY|||||||0.677||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.677
73853680|NCT01942668|147255541|SUPERIORITY|||||||0.073||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.073
73853681|NCT01942668|147255541|SUPERIORITY|||||||0.301||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.301
73853682|NCT01942668|147255541|SUPERIORITY|||||||0.013||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.013
73853683|NCT01942668|147255542|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.003
73853684|NCT01942668|147255542|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||<0.001
73853685|NCT01942668|147255542|SUPERIORITY|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.135
73853686|NCT01942668|147255542|SUPERIORITY|||||||0.231||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.231
73853687|NCT01942668|147255542|SUPERIORITY|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.377
73903854|NCT04626310|147338078|SUPERIORITY||Linear slope difference DBT-IE-IP|-0.165|STANDARD_ERROR_OF_MEAN|0.094||0.078|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.078
73903855|NCT04626310|147338078|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.167|STANDARD_ERROR_OF_MEAN|0.095||0.08|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.080
73903856|NCT04626310|147338079|SUPERIORITY||Linear Slope Diff DBT-ER-IP|0.091|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.13
74084917|NCT00434837|147723373|SUPERIORITY|||||||0.14|||||||ANOVA|||These results were from the 15-year analysis.||||.14
74084918|NCT00434837|147723374|SUPERIORITY|||||||0.067|||||||ANOVA|||These results are from the 15-year analysis.||||.067
74084919|NCT00434837|147723375|SUPERIORITY|||||||0.54|||||||ANOVA|||These results were from the 7-year analysis.||||.54
74084920|NCT00434837|147723376|SUPERIORITY|||||||0.08|||||||ANOVA|||These results are from the 15-year analysis.||||.08
74084921|NCT02786927|147723404|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73853688|NCT01942668|147255542|SUPERIORITY|||||||0.478||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.478
73853689|NCT01942668|147255542|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.015
73853690|NCT01942668|147255542|SUPERIORITY|||||||0.1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.100
73903857|NCT04626310|147338079|SUPERIORITY||Linear slope difference DBT-IE-IP|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.046|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.046
73903858|NCT04626310|147338079|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.028|STANDARD_ERROR_OF_MEAN|0.057||0.617|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.617
73903859|NCT04626310|147338080|SUPERIORITY||Linear slope difference DBT-ER-IP|-0.29|STANDARD_ERROR_OF_MEAN|0.103||0.005|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.005
73903860|NCT04626310|147338080|SUPERIORITY||Linear slope difference DBT-IE-IP|-0.111|STANDARD_ERROR_OF_MEAN|0.103||0.281|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.281
73903861|NCT04626310|147338080|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.18|STANDARD_ERROR_OF_MEAN|0.098||0.066|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.066
73903862|NCT04626310|147338081|SUPERIORITY||Linear slope difference DBT-ER-IP|1.049|STANDARD_ERROR_OF_MEAN|0.653||0.108|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.108
73903863|NCT04626310|147338081|SUPERIORITY||Linear slope difference DBT-IE-IP|-1.21|STANDARD_ERROR_OF_MEAN|0.454||0.014|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.014
74024861|NCT01309737|147602225|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.1|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|-65.33|-50.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-50.86|-65.33|<0.0001
73903864|NCT04626310|147338081|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|2.17|STANDARD_ERROR_OF_MEAN|0.631||0.001|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.001
73903865|NCT04626310|147338082|OTHER||Linear Slope difference DBT-ER-IP|0.17|STANDARD_ERROR_OF_MEAN|0.136||0.211|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.211
73903866|NCT04626310|147338082|SUPERIORITY||Linear Slope difference DBT-IE-IP|-0.195|STANDARD_ERROR_OF_MEAN|0.135||0.148|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.148
74084922|NCT02786927|147723405|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73903867|NCT04626310|147338082|SUPERIORITY||Linear Slope difference DBT-ER-DBT-IE|-0.025|STANDARD_ERROR_OF_MEAN|0.137||0.857|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.857
73903868|NCT04626310|147338083|SUPERIORITY||Linear Slope Difference in DSS DBT-ER-IP|-0.313|STANDARD_ERROR_OF_MEAN|0.794||0.693|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.693
73903869|NCT04626310|147338083|SUPERIORITY||Linear Slope Difference in DSS DBT-IE-IP|0.002|STANDARD_ERROR_OF_MEAN|0.767||0.998|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.998
74084923|NCT02786927|147723406|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74024862|NCT01309737|147602225|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.36|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-18.24|-6.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-6.48|-18.24|<0.0001
73853691|NCT01942668|147255543|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
73853692|NCT01942668|147255543|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
73853693|NCT01942668|147255543|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.009
73853694|NCT01942668|147255543|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.017
73853695|NCT01942668|147255543|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.001
73853696|NCT01942668|147255543|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.025
73853697|NCT01942668|147255543|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
73853698|NCT01942668|147255543|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
73853699|NCT01942668|147255544|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||<0.001
73853700|NCT01942668|147255544|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||<0.001
73853701|NCT01942668|147255544|SUPERIORITY|||||||0.066||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.066
73853702|NCT01942668|147255544|SUPERIORITY|||||||0.055||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.055
73853703|NCT01942668|147255544|SUPERIORITY|||||||0.174||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.174
73853704|NCT01942668|147255544|SUPERIORITY|||||||0.319||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.319
73853705|NCT01942668|147255544|SUPERIORITY|||||||0.007||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.007
73853706|NCT01942668|147255544|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.008
73853707|NCT01942668|147255545|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
73903870|NCT04626310|147338083|SUPERIORITY||Linear Slope Diff in DSS DBT-ER-DBT-IE|-0.315|STANDARD_ERROR_OF_MEAN|0.765||0.68|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.680
73903871|NCT04626310|147338083|SUPERIORITY||Linear Slope Difference in DC1 DBT-ER-IP|0.098|STANDARD_ERROR_OF_MEAN|0.101||0.333|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.333
73903872|NCT04626310|147338083|SUPERIORITY||Linear Slope Diff in DC1 DBT-IE-IP|-0.046|STANDARD_ERROR_OF_MEAN|0.097||0.632|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.632
73903873|NCT04626310|147338083|SUPERIORITY||Linear Slope Diff in DC1 DBT-ER-DBT-IE|0.144|STANDARD_ERROR_OF_MEAN|0.107||0.178|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to DBT-ER.||||.178
73853708|NCT01942668|147255545|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||<0.001
73853709|NCT01942668|147255545|SUPERIORITY|||||||0.019||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.019
73853710|NCT01942668|147255545|SUPERIORITY|||||||0.061||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.061
73853711|NCT01942668|147255545|SUPERIORITY|||||||0.026||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.026
73853712|NCT01942668|147255545|SUPERIORITY|||||||0.104||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.104
73903874|NCT04626310|147338083|SUPERIORITY||Linear Slope Diff in DC2 DBT-ER-IP|0.045|STANDARD_ERROR_OF_MEAN|0.112||0.689|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-ER to IP.||||.689
73903875|NCT04626310|147338083|SUPERIORITY||Linear Slope Diff in DC2 DBT-IE-IP|-0.011|STANDARD_ERROR_OF_MEAN|0.109||0.917|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-IE to IP.||||.917
73903876|NCT04626310|147338083|SUPERIORITY||Linear Slope Diff in DC2 DBT-ER-DBT-IE|0.056|STANDARD_ERROR_OF_MEAN|0.108||0.603|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-ER to DBT-IE.||||.603
73903877|NCT04626310|147338084|SUPERIORITY||Other[Quad Slope difference DBT-ER-IP]|0.013|STANDARD_ERROR_OF_MEAN|0.044||0.762|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.762
73903878|NCT04626310|147338084|SUPERIORITY||Quad Slope difference DBT-IE-IP|0.034|STANDARD_ERROR_OF_MEAN|0.047||0.478|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.478
73903879|NCT04626310|147338084|SUPERIORITY||Quad Slope difference DBT-ER-DBT-IE|-0.089|STANDARD_ERROR_OF_MEAN|0.054||0.705|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.705
73903880|NCT04626310|147338085|SUPERIORITY||Quad slope difference DBT-ER-IP|-0.028|STANDARD_ERROR_OF_MEAN|0.15||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
73903881|NCT04626310|147338085|SUPERIORITY||Quad slope difference DBT-IE-IP|-0.029|STANDARD_ERROR_OF_MEAN|0.145||0.836|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.836
73903882|NCT04626310|147338085|SUPERIORITY||Quad slope difference DBT-ER-DBT-IE|0.001|STANDARD_ERROR_OF_MEAN|0.145||0.994|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.994
73903883|NCT04626310|147338086|SUPERIORITY||Quad slope diff in DC1 DBT-ER-IP|0.013|STANDARD_ERROR_OF_MEAN|0.013||0.313|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-ER to IP.||||.313
73962473|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.3571|TWO_SIDED|95.0|-0.39|0.14|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.14|-0.39|0.3571
73962474|NCT02528188|147460959|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.9072|TWO_SIDED|95.0|-0.25|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.28|-0.25|0.9072
74024863|NCT01309737|147602226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.5|||<|0.0001||95.0|3.48|17.31||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||17.31|3.48|<0.0001
73903884|NCT04626310|147338086|SUPERIORITY||Quad Slope in DC1 DBT-IE-IP|0.003|STANDARD_ERROR_OF_MEAN|0.01||0.747|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-IE to IP.||||.747
73903885|NCT04626310|147338086|SUPERIORITY||Quad slope diff in DC1 DBT-ER-DBT-IE|0.009|STANDARD_ERROR_OF_MEAN|0.012||0.444|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-ER to DBT-IE.||||.444
73903886|NCT01617148|147338087|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73903887|NCT01617148|147338088|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73903888|NCT01617148|147338089|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||||||0.038
73903889|NCT01617148|147338090|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||||||0.038
73903890|NCT04218123|147338098|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||<|0.001|||||||ANOVA|||||||<0.001
73903891|NCT04218123|147338098|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||<|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||<0.05
73853713|NCT01942668|147255545|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
73853714|NCT01942668|147255545|SUPERIORITY|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.018
73962475|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.49|0.0004
73853715|NCT01942668|147255546|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
73853716|NCT01942668|147255546|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
73853717|NCT01942668|147255546|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.006
73853718|NCT01942668|147255546|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.003
73853719|NCT01942668|147255546|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.017
73853720|NCT01942668|147255546|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.025
73853721|NCT01942668|147255546|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.001
73853722|NCT01942668|147255546|SUPERIORITY|||||||0.037||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.037
73853723|NCT01942668|147255547|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||<0.001
73853724|NCT01942668|147255547|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
73853725|NCT01942668|147255547|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.001
73853726|NCT01942668|147255547|SUPERIORITY|||||||0.016||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.016
73903892|NCT04218123|147338098|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||<|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||<0.05
73903893|NCT04218123|147338098|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||>|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||>0.05
73903894|NCT04218123|147338100|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.31|||||||ANOVA|||SF20 Physical Functioning||||=0.31
73903895|NCT04218123|147338100|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.633|||||||ANOVA|||SF20 Role Functioning||||0.633
73903896|NCT04218123|147338100|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.424|||||||ANOVA|||SF20 Mental Health||||0.424
73903897|NCT04218123|147338100|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.057|||||||ANOVA|||SF20 Social Functioning||||0.057
73853727|NCT01942668|147255547|SUPERIORITY|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.012
73853728|NCT01942668|147255547|SUPERIORITY|||||||0.053||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.053
73853729|NCT01942668|147255547|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.004
73853730|NCT01942668|147255547|SUPERIORITY|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.074
73853731|NCT01942668|147255548|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
73853732|NCT01942668|147255548|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
73853733|NCT01942668|147255548|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
73903898|NCT04218123|147338100|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.296|||||||ANOVA|||SF20 Health Perceptions||||0.296
73903899|NCT04218123|147338100|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.872|||||||ANOVA|||SF20 Pain||||0.872
73903900|NCT04218123|147338101|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.538|||||||ANOVA|||||||=0.538
73903901|NCT04218123|147338102|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.686|||||||ANOVA|||||||=0.686
73903902|NCT04218123|147338103|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.167|||||||ANOVA|||||||=0.167
73903903|NCT04218123|147338104|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.8|||||||ANOVA|||||||=0.8
73903904|NCT04218123|147338105|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.425|||||||ANOVA|||||||=0.425
73903905|NCT04218123|147338106|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent.|||||=|0.054|||||||ANOVA|||||||=0.054
73903906|NCT00423670|147338107|SUPERIORITY_OR_OTHER||Percent difference in SVR|16.7||||0.0126|TWO_SIDED|95.0|3.5|30.0|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||30|3.5|0.0126
73903907|NCT00423670|147338107|SUPERIORITY_OR_OTHER||Percent difference in SVR|18.8||||0.0048|TWO_SIDED|95.0|5.5|32.2|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||32.2|5.5|0.0048
73903908|NCT00423670|147338107|SUPERIORITY_OR_OTHER||Percent difference in SVR|29.5|||<|0.0001|TWO_SIDED|95.0|16.5|42.5|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||42.5|16.5|<0.0001
73903909|NCT00423670|147338107|SUPERIORITY_OR_OTHER||Percent difference in SVR|37.3|||<|0.0001|TWO_SIDED|95.0|24.7|49.8|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||49.8|24.7|<0.0001
73962476|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.0134|TWO_SIDED|95.0|-0.4|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.40|0.0134
73962477|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.56|-0.19|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.19|-0.56|<0.0001
74024864|NCT01309737|147602226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.53|||<|0.0001|TWO_SIDED|95.0|8.08|46.22||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||46.22|8.08|<0.0001
74024865|NCT01309737|147602226|SUPERIORITY_OR_OTHER||Percent Difference|14.3|STANDARD_ERROR_OF_MEAN|3.36|<|0.0001|TWO_SIDED|95.0|7.72|20.88|||Normal Approximation|||||20.88|7.72|<0.0001
73903910|NCT00423670|147338108|SUPERIORITY_OR_OTHER||Percent difference in SVR rates|5.1||||0.2864|TWO_SIDED|95.0|-4.2|14.3|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.||||14.3|-4.2|0.2864
73903911|NCT00423670|147338109|SUPERIORITY_OR_OTHER||Percent difference in SVR rates|15.6||||0.0009|TWO_SIDED|95.0|6.5|24.8|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for the baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.||||24.8|6.5|0.0009
73903912|NCT01082640|147338115|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.134||0.459|TWO_SIDED|95.0|-0.37|0.17||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.||0.17|-0.37|0.459
74024866|NCT01309737|147602228|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.97|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-3.8|-2.14||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-2.14|-3.80|<0.0001
73903913|NCT01082640|147338115|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.133||0.789|TWO_SIDED|95.0|-0.23|0.3||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.||0.30|-0.23|0.789
73903914|NCT01082640|147338116|SUPERIORITY_OR_OTHER||LS mean difference|2.38|STANDARD_ERROR_OF_MEAN|1.687||0.162|TWO_SIDED|95.0|-0.97|5.73||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||||5.73|-0.97|0.162
73903915|NCT01082640|147338116|SUPERIORITY_OR_OTHER||LS mean difference|1.19|STANDARD_ERROR_OF_MEAN|1.698||0.485|TWO_SIDED|95.0|-2.18|4.57||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||||4.57|-2.18|0.485
73903916|NCT01082640|147338117|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||<0.001
73903917|NCT01082640|147338117|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||<0.001
73903918|NCT01082640|147338117|SUPERIORITY_OR_OTHER|||||||0.062|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||0.062
73903919|NCT03577171|147338121|OTHER||LS Mean Difference|-1.154||||0.0077|TWO_SIDED|95.0|-1.986|-0.322|||Repeated measures analysis|||Least Squares (LS) Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 12||-0.322|-1.986|0.0077
73903920|NCT03577171|147338121|OTHER||LS Mean Difference|-1.141||||0.0084|TWO_SIDED|95.0|-1.973|-0.309|||Repeated measures analysis|||Least Squares Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 24||-0.309|-1.973|0.0084
73903921|NCT03190369|147338138|SUPERIORITY||LS Mean difference|0.125|STANDARD_ERROR_OF_MEAN|0.137||0.361|TWO_SIDED|95.0|-0.144|0.395||Threshold for significance at 0.05 level.|ANCOVA|Least-square (LS) means, standard errors (SE) were analyzed from repeated measures ANCOVA.||Least-square (LS) means, standard errors (SE) were analyzed from repeated measures analysis of covariance (ANCOVA). The model included treatment groups (Hylan G-F 20 and placebo), site, visit and visit by treatment interaction, as well as the baseline WOMAC A1 score as a covariate).||0.395|-0.144|0.3610
73903922|NCT02011893|147338145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 7.5 points, where the Visual Analog Scale (VAS) scores were measured on a scale of 0 to 100. Testing was carried out at a 5% significance level.|||||<|0.001|||||||t-distribution|95% UCB and p-value for non-inferiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.||||||<0.001
73903923|NCT02011893|147338146|SUPERIORITY_OR_OTHER|||||||0.083||||||Superiority analysis performed|McNemar|||||||0.083
73903924|NCT02011893|147338148|SUPERIORITY_OR_OTHER|||||||0.017||||||Superiority analysis performed|t-distribution|95% UCB and p-value for superiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.||||||0.017
73903925|NCT00450112|147338152|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Fisher Exact|||||||>0.1
73903926|NCT00450112|147338153|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
73903927|NCT00450112|147338153|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
73903928|NCT00450112|147338154|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
73903929|NCT00450112|147338154|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
73903930|NCT00450112|147338155|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
73962478|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.29|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-0.67|<0.0001
74084924|NCT01801917|147723407|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.586||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 2mg group vs. placebo||||
73903931|NCT00450112|147338155|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
73903932|NCT00450112|147338156|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed..||||<0.0001
73903933|NCT00450112|147338156|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
73903934|NCT00450112|147338158|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
73903935|NCT00450112|147338158|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
73903936|NCT00450112|147338159|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
73903937|NCT00450112|147338159|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
73903938|NCT06138145|147338171|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73903939|NCT06138145|147338171|OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mann-Whitney U test|||||||<0.05
73903940|NCT06138145|147338171|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73903941|NCT03614975|147338174|OTHER|||||||0.28||||||A/H1N1|Chi-squared|||||||0.28
73903942|NCT03614975|147338174|OTHER|||||||0.64||||||A/H3N2|Chi-squared|||||||0.64
73903943|NCT03614975|147338174|OTHER|||||||0.64||||||B/Colorado|Chi-squared|||||||0.64
73903944|NCT03614975|147338174|OTHER|||||||0.23||||||B/Phuket|Chi-squared|||||||0.23
73903945|NCT03614975|147338175|OTHER|||||||0.42||||||Vaccine Strain: A/H1N1:Day 0|Chi-squared|||||||0.42
73903946|NCT03614975|147338175|OTHER|||||||0.16||||||Vaccine Strain: A/H1N1: Day 21|Chi-squared|||||||0.16
73903947|NCT03614975|147338175|OTHER|||||||0.42||||||Vaccine Strain: A/H3N2: Day 0|Chi-squared|||||||0.42
73903948|NCT03614975|147338175|OTHER|||||||0.94||||||Vaccine Strain: A/H3N2: Day 21|Chi-squared|||||||0.94
73903949|NCT03614975|147338175|OTHER|||||||0.87||||||Vaccine Strain: B/Colorado :Day 0|Chi-squared|||||||0.87
73903950|NCT03614975|147338175|OTHER|||||||0.77||||||Vaccine Strain: B/Colorado : Day 21|Chi-squared|||||||0.77
73903951|NCT03614975|147338175|OTHER|||||||0.33||||||Vaccine Strain: B/Phuket: Day 0|Chi-squared|||||||0.33
73903952|NCT03614975|147338175|OTHER|||||||0.21||||||Vaccine Strain: B/Phuket: Day 21|Chi-squared|||||||0.21
73903953|NCT03614975|147338176|OTHER|||||||0.49||||||Vaccine Strain: A/H1N1: Day 0|Kruskal-Wallis|||||||0.49
73903954|NCT03614975|147338176|OTHER|||||||0.23||||||Vaccine Strain: A/H1N1: Day 21|Kruskal-Wallis|||||||0.23
73903955|NCT03614975|147338176|OTHER|||||||0.1||||||Vaccine Strain: A/H3N2: Day 0|Kruskal-Wallis|||||||0.10
73903956|NCT03614975|147338176|OTHER|||||||0.86||||||Vaccine Strain: A/H3N2: Day 21|Kruskal-Wallis|||||||0.86
73903957|NCT03614975|147338176|OTHER|||||||0.73||||||Vaccine Strain: B/Colorado: Day 0|Kruskal-Wallis|||||||0.73
73903958|NCT03614975|147338176|OTHER|||||||0.67||||||Vaccine Strain: B/Colorado: Day 21|Kruskal-Wallis|||||||0.67
73903959|NCT03614975|147338176|OTHER|||||||0.36||||||Vaccine Strain: B/Phuket: Day 0|Kruskal-Wallis|||||||0.36
73903960|NCT03614975|147338176|OTHER|||||||0.65||||||Vaccine Strain: B/Phuket: Day 21|Kruskal-Wallis|||||||0.65
73903961|NCT01569464|147338177|SUPERIORITY_OR_OTHER||LS Mean|-0.27|STANDARD_ERROR_OF_MEAN|1.36||0.8451|TWO_SIDED|95.0|-2.96|2.42||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.||2.42|-2.96|0.8451
73903962|NCT01569464|147338178|SUPERIORITY_OR_OTHER||LS Mean|0.07|STANDARD_ERROR_OF_MEAN|0.34||0.8336|TWO_SIDED|95.0|-0.61|0.75||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.||0.75|-0.61|0.8336
73903963|NCT02797054|147338235|OTHER|||||||0.069|||||||Chi-squared|||||||0.069
73903964|NCT02797054|147338236|OTHER|||||||0.303|||||||Chi-squared|||||||0.303
73962479|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0031|TWO_SIDED|95.0|-0.49|-0.1|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.10|-0.49|0.0031
73962480|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.82|-0.43|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-0.82|<0.0001
73962481|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0425|TWO_SIDED|95.0|-0.43|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.01|-0.43|0.0425
73903965|NCT02797054|147338237|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
73903966|NCT02797054|147338238|OTHER|||||||0.895|||||||Chi-squared|||||||0.895
73962482|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.65|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-0.65|<0.0001
73903967|NCT02797054|147338239|OTHER|||||||0.58|||||||Chi-squared|||||||0.58
73903968|NCT02797054|147338240|OTHER|||||||0.0015|||||||Chi-squared|||||||0.0015
73903969|NCT02797054|147338241|OTHER|||||||0.0056|||||||Chi-squared|||||||0.0056
73903970|NCT02797054|147338242|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
73903971|NCT04644783|147338243|SUPERIORITY||||||<|0.0001|||||||Regression, non-linear mixed effects|||||||<0.0001
73903972|NCT04644783|147338244|SUPERIORITY||||||<|0.0001|||||||Regression, non-linear mixed effects|||||||<0.0001
73903973|NCT01369485|147338245|SUPERIORITY_OR_OTHER|||||||0.3636|||||||Chi-squared|||The sample size calculation was determined using the 2-sided Chi-square test with a significance level of 5% and 80% power based upon the following assumptions: (1) proportion of responders at end of 12 weeks of treatment would be 50% in the active (test) group and 25% in the inactive (control) group; (2) a responder was defined as a subject who experienced decrease of ≥50% in mean urgency urinary incontinence episodes (leaks) between baseline and Week 12 of the study; (3) 20 % dropout rate.||||0.3636
73903974|NCT01369485|147338245|SUPERIORITY_OR_OTHER|||||||0.4849|||||||Chi-squared|||||||0.4849
73903975|NCT01369485|147338246|SUPERIORITY_OR_OTHER|||||||0.2893|||||||Wilcoxon (Mann-Whitney)|||||||0.2893
73903976|NCT01369485|147338246|SUPERIORITY_OR_OTHER|||||||0.3223|||||||Wilcoxon (Mann-Whitney)|||||||0.3223
73903977|NCT01369485|147338247|SUPERIORITY_OR_OTHER|||||||0.3387|||||||Wilcoxon (Mann-Whitney)|||||||0.3387
73903978|NCT01369485|147338248|SUPERIORITY_OR_OTHER|||||||0.6557|||||||Wilcoxon (Mann-Whitney)|||||||0.6557
73903979|NCT01369485|147338249|SUPERIORITY_OR_OTHER|||||||0.4354|||||||Wilcoxon (Mann-Whitney)|||||||0.4354
73903980|NCT01369485|147338250|SUPERIORITY_OR_OTHER|||||||0.9918|||||||Wilcoxon (Mann-Whitney)|||||||0.9918
73903981|NCT01369485|147338250|SUPERIORITY_OR_OTHER|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||||||0.3770
73903982|NCT01369485|147338251|SUPERIORITY_OR_OTHER|||||||0.4147|||||||Fisher Exact|||||||0.4147
73903983|NCT01369485|147338251|SUPERIORITY_OR_OTHER|||||||0.0877|||||||Fisher Exact|||||||0.0877
73903984|NCT01369485|147338252|SUPERIORITY_OR_OTHER|||||||0.2032|||||||Fisher Exact|||||||0.2032
73903985|NCT01369485|147338253|SUPERIORITY_OR_OTHER|||||||0.4151||||||Calculated for only those patients who had prior OAB treatment only.|Wilcoxon (Mann-Whitney)|||||||0.4151
73903986|NCT01369485|147338254|SUPERIORITY_OR_OTHER|||||||0.9814|||||||Fisher Exact|||"Endpoint defined as percentage of patients that much improved or very much improved following treatment."||||0.9814
73903987|NCT01369485|147338254|SUPERIORITY_OR_OTHER|||||||0.7305|||||||Fisher Exact|||||||0.7305
73903988|NCT01369485|147338255|SUPERIORITY_OR_OTHER|||||||0.2191|||||||Wilcoxon (Mann-Whitney)|||||||0.2191
73903989|NCT01369485|147338255|SUPERIORITY_OR_OTHER|||||||0.5357|||||||Wilcoxon (Mann-Whitney)|||||||0.5357
73903990|NCT04706416|147338258|SUPERIORITY||Odds Ratio (OR)|0.6||||0.297|TWO_SIDED|95.0|0.26|1.48|||Fisher Exact|||||1.48|0.26|0.297
73903991|NCT04706416|147338258|SUPERIORITY||Odds Ratio (OR)|0.68||||0.541|TWO_SIDED|95.0|0.19|2.3|||Regression, Logistic|||||2.30|0.19|0.541
73903992|NCT04706416|147338259|SUPERIORITY||Odds Ratio (OR)|0.37||||0.039|TWO_SIDED|95.0|0.15|0.91|||Fisher Exact|||||0.91|0.15|0.039
73903993|NCT04706416|147338259|SUPERIORITY||Odds Ratio (OR)|0.34||||0.081|TWO_SIDED|95.0|0.09|1.07|||Regression, Logistic|||||1.07|0.09|0.081
73903994|NCT04706416|147338260|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.643|TWO_SIDED|95.0|-1.0|3.0|||Wilcoxon (Mann-Whitney)|||||3.0|-1.0|0.643
73903995|NCT04706416|147338260|SUPERIORITY||β-coefficient|-4.27||||0.001|TWO_SIDED|95.0|-5.67|-2.87|||Regression, Linear|||||-2.87|-5.67|0.001
73903996|NCT04706416|147338261|SUPERIORITY||Odds Ratio (OR)|0.53||||0.133|TWO_SIDED|95.0|0.25|1.19|||Fisher Exact|||||1.19|0.25|0.133
73903997|NCT04706416|147338262|SUPERIORITY||Hodges-Lehmann estimator|4.0||||0.092|TWO_SIDED|95.0|-1.0|12.0|||Wilcoxon (Mann-Whitney)|||||12.0|-1.0|0.092
73903998|NCT04706416|147338263|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.834|TWO_SIDED|95.0|-2.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.0|-2.0|0.834
73903999|NCT04706416|147338264|SUPERIORITY||Odds Ratio (OR)|0.001||||0.149|TWO_SIDED|95.0|0.0|1.52|||Fisher Exact|||||1.52|0|0.149
73904000|NCT04706416|147338265|SUPERIORITY||Odds Ratio (OR)|0.3||||0.015|TWO_SIDED|95.0|0.12|0.8|||Fisher Exact|||||0.80|0.12|0.015
73904001|NCT01539317|147338271|SUPERIORITY_OR_OTHER|||||||0.0149|||||||Wilcoxon (Mann-Whitney)|||Phase II: During Blinded 4 weeks||||0.0149
73904002|NCT01539317|147338271|SUPERIORITY_OR_OTHER|||||||0.412|||||||Wilcoxon (Mann-Whitney)|||Phase III||||0.412
73904003|NCT01539317|147338272|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Desire||||0.66
73904004|NCT01539317|147338272|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Arousal (S)||||0.11
73904005|NCT01539317|147338272|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Arousal (L)||||0.15
73904006|NCT01539317|147338272|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Arousal (C)||||0.28
73904007|NCT01539317|147338272|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Orgasm||||0.07
73904008|NCT01539317|147338272|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Pain||||0.004
73904009|NCT01539317|147338272|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Enjoyment||||0.54
73904010|NCT01539317|147338272|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Partner||||0.92
73904011|NCT01539317|147338273|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Each of 8 site comparisons had its own P-value and a value of \<0.001 was the difference at the most tender sites|Wilcoxon (Mann-Whitney)|||||||<0.001
73904012|NCT02730208|147338280|OTHER|Treatment effect outcomes are estimates.|Least Squares (LS) Mean Difference|-1.48|||||TWO_SIDED|95.0|-7.47|4.52||||||||4.52|-7.47|
73904013|NCT00245219|147338282|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73904014|NCT00245219|147338282|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73904015|NCT00245219|147338282|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73904016|NCT00245219|147338282|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73904017|NCT00245219|147338282|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73904018|NCT00245219|147338282|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73904019|NCT00245219|147338282|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73904020|NCT00245219|147338282|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73904021|NCT00245219|147338283|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73904022|NCT00245219|147338283|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73904023|NCT00245219|147338283|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73962483|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.298|TWO_SIDED|95.0|-0.4|0.12|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.40|0.2980
73962484|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.13||0.0179|TWO_SIDED|95.0|-0.58|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.58|0.0179
73962485|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.13||0.2328|TWO_SIDED|95.0|-0.42|0.1|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.42|0.2328
73962486|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.1019|TWO_SIDED|95.0|-0.49|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.49|0.1019
73962487|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.4002|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4002
73962488|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2149|TWO_SIDED|95.0|-0.45|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.45|0.2149
74024867|NCT01309737|147602228|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-5.13|-3.47||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.47|-5.13|<0.0001
74088284|NCT02709486|147729993|SUPERIORITY||Least Square Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.86||0.0079|TWO_SIDED|95.0|-8.59|-1.3|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect||-1.30|-8.59|0.0079
73904024|NCT00245219|147338283|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73904025|NCT00245219|147338283|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73904026|NCT00245219|147338283|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73904027|NCT00245219|147338283|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73904028|NCT00245219|147338283|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73904029|NCT00245219|147338284|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73904030|NCT00245219|147338284|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73904031|NCT00245219|147338284|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73904032|NCT00245219|147338284|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
73962489|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2442|TWO_SIDED|95.0|-0.43|0.11|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.43|0.2442
73962490|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4609|TWO_SIDED|95.0|-0.37|0.17|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.37|0.4609
74024868|NCT01309737|147602228|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.35||0.0001|TWO_SIDED|95.0|-2.01|-0.65|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.65|-2.01|0.0001
74084925|NCT01801917|147723407|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.022||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 2mg group vs. placebo||||
73904033|NCT00245219|147338284|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73962491|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8129|TWO_SIDED|95.0|-0.31|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.31|0.8129
73962492|NCT02528188|147460961|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7883|TWO_SIDED|95.0|-0.32|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.32|0.7883
73962493|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.0119|TWO_SIDED|95.0|-0.37|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.37|0.0119
73962494|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3073|TWO_SIDED|95.0|-0.24|0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.24|0.3073
73962495|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09||0.0002|TWO_SIDED|95.0|-0.5|-0.15|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.50|0.0002
73962496|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.56|<0.0001
73962497|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.09||0.0251|TWO_SIDED|95.0|-0.39|-0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.03|-0.39|0.0251
73962498|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.66|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.30|-0.66|<0.0001
73962499|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0625|TWO_SIDED|95.0|-0.39|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.01|-0.39|0.0625
73962500|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.54|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.54|0.0010
73962501|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4005|TWO_SIDED|95.0|-0.36|0.14|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.14|-0.36|0.4005
74084926|NCT01801917|147723407|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.963||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 10mg group vs. placebo||||
74088285|NCT02709486|147730008|SUPERIORITY||Odds Ratio (OR)|0.1||||0.0027|TWO_SIDED|95.0|0.02|0.46|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.||0.46|0.02|0.0027
73904034|NCT00245219|147338284|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73904035|NCT00245219|147338284|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73904036|NCT00245219|147338284|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
73904037|NCT01827358|147338288|OTHER|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p\_((1)) (smaller p-value) and p\_((2)) (larger p-value). If p\_((1))=0.025 and p\_((2))=0.05, then the null hypotheses for both tests are rejected. If p\_((1))=0.025 and p\_((2))\>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|315.2|||<|0.001|TWO_SIDED|97.5|49.6|2698.8|||Fisher Exact|||||2698.8|49.6|<0.001
73904038|NCT01827358|147338289|OTHER|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p\_((1)) (smaller p-value) and p\_((2)) (larger p-value). If p\_((1))=0.025 and p\_((2))=0.05, then the null hypotheses for both tests are rejected. If p\_((1))=0.025 and p\_((2))\>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|39.5|||<|0.001|TWO_SIDED|95.0|5.5|1666.3|||Fisher Exact|||||1666.3|5.5|<0.001
73904039|NCT01827358|147338290|OTHER||Hazard Ratio (HR)|1.0||||0.997|TWO_SIDED|95.0|0.3|3.28|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.||3.28|0.30|0.997
73904040|NCT01827358|147338291|OTHER||Hazard Ratio (HR)|1.33||||0.656|TWO_SIDED|95.0|0.37|4.76|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.||4.76|0.37|0.656
73962502|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.13||0.053|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.00|-0.50|0.0530
73962503|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4074|TWO_SIDED|95.0|-0.37|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.37|0.4074
74084927|NCT01801917|147723407|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.837||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 10mg group vs. placebo||||
73962504|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2629|TWO_SIDED|95.0|-0.41|0.11|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.41|0.2629
73962505|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.5582|TWO_SIDED|95.0|-0.34|0.18|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.18|-0.34|0.5582
73904041|NCT01827358|147338293|OTHER||Hazard Ratio (HR)|0.23||||0.182|TWO_SIDED|95.0|0.03|2.01|||Cox proportional hazards models|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.||2.01|0.03|0.182
73904042|NCT01827358|147338294|OTHER||Hazard Ratio (HR)|0.24||||0.198|TWO_SIDED|95.0|0.03|2.12|||Cox proportional hazards model|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.||2.12|0.03|0.198
73904043|NCT00510952|147338299|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin was 0.4%.|Mean Difference (Net)|-0.05||||0.551||95.0|-0.21|0.11||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin glargine, injected once a day, with regard to glycemic control as measured by change in HbA1c from baseline to 24 week endpoint (last observation carried forward).||0.11|-0.21|0.551
73904044|NCT00510952|147338300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.09|-0.21|0.427
73904045|NCT00510952|147338300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.09|-0.21|0.427
73904046|NCT00510952|147338300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.07|-0.25|0.254
73904047|NCT00510952|147338300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.07|-0.25|0.254
73904048|NCT00510952|147338301|SUPERIORITY_OR_OTHER|||||||0.634||95.0||||P-value for HbA1c \<7.0%.|Fisher Exact|||||||0.634
73904049|NCT00510952|147338301|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||P-value for HbA1c ≤6.5%.|Fisher Exact|||||||0.504
73904050|NCT00510952|147338302|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.8 millimoles per liter (mmol/L).|Mean Difference (Net)|0.06||||0.323||95.0|-0.06|0.19|||ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatment groups (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Insulin lispro protamine suspension is noninferior to glargine at actual morning pre-meal at endpoint.||0.19|-0.06|0.323
73904051|NCT00510952|147338303|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value for Actual Morning Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.302
73904052|NCT00510952|147338303|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||P-value for Actual Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.144
73904053|NCT00510952|147338303|SUPERIORITY_OR_OTHER|||||||0.279||95.0||||P-value for Actual Midday Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.279
73904054|NCT00510952|147338303|SUPERIORITY_OR_OTHER|||||||0.928||95.0||||P-value for Actual Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.928
73904055|NCT00510952|147338303|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-value for Actual Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.918
73904056|NCT00510952|147338303|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-value for Actual Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.875
73904057|NCT00510952|147338303|SUPERIORITY_OR_OTHER|||||||0.316||95.0||||P-value for Actual 0300 Hours.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.316
73904058|NCT00510952|147338303|SUPERIORITY_OR_OTHER|||||||0.389||95.0||||P-value for Daily Mean 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.389
73904059|NCT00510952|147338303|SUPERIORITY_OR_OTHER|||||||0.836||95.0||||P-value for Daily Mean Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.836
73904060|NCT00510952|147338303|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value for Daily Mean Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.394
73904061|NCT00510952|147338303|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for Daily Mean Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.609
73904062|NCT00510952|147338304|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||P-value for All Hypoglycemic Episodes.|Fisher Exact|||||||0.468
73904063|NCT00510952|147338304|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.011
73904064|NCT00510952|147338304|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value for Severe Hypoglycemic Episodes.|Fisher Exact|||||||0.036
73904065|NCT00510952|147338305|SUPERIORITY_OR_OTHER|||||||0.316||95.0||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||0.316
73904066|NCT00510952|147338305|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||<0.001
73962506|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4907|TWO_SIDED|95.0|-0.35|0.17|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.35|0.4907
73962507|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4043|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4043
74088286|NCT02709486|147730008|SUPERIORITY||Odds Ratio (OR)|0.16||||0.0033|TWO_SIDED|95.0|0.05|0.54|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.||0.54|0.05|0.0033
73853734|NCT01942668|147255548|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
73853735|NCT01942668|147255548|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.009
73853736|NCT01942668|147255548|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||0.004
73853737|NCT01942668|147255548|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.002
73853738|NCT01942668|147255548|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||0.015
73853739|NCT01942668|147255549|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.004
73853740|NCT01942668|147255549|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
73853741|NCT01942668|147255549|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.002
73853742|NCT01942668|147255549|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.001
73853743|NCT01942668|147255549|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.001
73853744|NCT01942668|147255549|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.009
73853745|NCT01942668|147255549|SUPERIORITY|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.018
73853746|NCT01942668|147255549|SUPERIORITY|||||||0.021||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.021
73853747|NCT01942668|147255550|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
73853748|NCT01942668|147255550|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
73853749|NCT01942668|147255550|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
73853750|NCT01942668|147255550|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
73853751|NCT01942668|147255550|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
73853752|NCT01942668|147255550|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
73853753|NCT01942668|147255550|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
73853754|NCT01942668|147255550|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
73853755|NCT01942668|147255551|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
73853756|NCT01942668|147255551|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
73853757|NCT01942668|147255551|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
73853758|NCT01942668|147255551|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
73853759|NCT01942668|147255551|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||0.006
73904067|NCT00510952|147338305|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||0.102
73904068|NCT00510952|147338307|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|-0.01||||0.975||95.0|-0.61|0.59||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: insulin lispro protamine suspension is noninferior to glargine with regard to change in absolute body weight from baseline to endpoint.||0.59|-0.61|0.975
73904069|NCT00510952|147338308|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.031
73904070|NCT00510952|147338309|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.015
73904071|NCT02101112|147338377|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.054|||||TWO_SIDED|90.0|0.994|1.118||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.118|0.994|
73904072|NCT02101112|147338377|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.788|||||TWO_SIDED|90.0|0.741|0.839||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.839|0.741|
73962508|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7663|TWO_SIDED|95.0|-0.31|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.31|0.7663
73962509|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7415|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7415
73962510|NCT02528188|147460963|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8688|TWO_SIDED|95.0|-0.24|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.24|0.8688
73904073|NCT02101112|147338378|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.027|||||TWO_SIDED|90.0|0.981|1.076||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.076|0.981|
73904074|NCT02101112|147338378|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.835|||||TWO_SIDED|90.0|0.797|0.875||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.875|0.797|
73904075|NCT02101112|147338379|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.027|||||TWO_SIDED|90.0|0.981|1.075||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.075|0.981|
73962511|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.3622|TWO_SIDED|95.0|-0.25|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.09|-0.25|0.3622
73962512|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.3894|TWO_SIDED|95.0|-0.09|0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.09|0.3894
74024869|NCT01309737|147602228|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.46|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-5.51|-3.42||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.42|-5.51|<0.0001
73904076|NCT02101112|147338379|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.832|||||TWO_SIDED|90.0|0.794|0.871||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.871|0.794|
73904077|NCT04340063|147338395|OTHER||Odds Ratio, log|0.4|||<|0.001|TWO_SIDED|95.0|0.25|0.55||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant was used and fixed effects were time (assessment order) and a time by group interaction (Treadmill or Movement Amplification). A binomial distribution was used for this model.||0.55|0.25|<0.001
73904078|NCT04340063|147338395|OTHER||Odds Ratio, log|-0.03||||0.8|TWO_SIDED|95.0|-0.22|0.16||Interaction effect for time (pre-, mid-, and post- assessments) by group (Movement Amplification)|Mixed Models Analysis|||||0.16|-0.22|0.8
74088287|NCT02709486|147730009|SUPERIORITY|||||||0.0002||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0002
73904079|NCT04340063|147338395|OTHER||Odds Ratio, log|0.09||||0.5|TWO_SIDED|95.0|-0.18|0.36||Effect of time (post-training and follow-up assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.||0.36|-0.18|0.5
73904080|NCT04340063|147338395|OTHER||Odds Ratio, log|-0.07||||0.6|TWO_SIDED|95.0|-0.31|0.17||Interaction effect of time (post-training and follow-up assessments) by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.||0.17|-0.31|0.6
73904081|NCT04340063|147338396|OTHER||Slope|0.06||||0.8|TWO_SIDED|95.0|-0.5|0.62||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and time by group (Treadmill or Movement Amplification) interaction were used||0.62|-0.50|0.8
73904082|NCT04340063|147338396|OTHER||Slope|-0.7||||0.012|TWO_SIDED|95.0|-1.2|-0.16||Interaction effect of time by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||-0.16|-1.2|0.012
73904083|NCT04340063|147338396|OTHER||Slope|0.26||||0.3|TWO_SIDED|95.0|-0.22|0.75||Effect of time (post-training to follow-up)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||0.75|-0.22|0.3
73904084|NCT04340063|147338396|OTHER||Slope|-0.2||||0.4|TWO_SIDED|95.0|-0.69|0.29||Interaction effect of time (post-training to follow-up) by group|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||0.29|-0.69|0.4
73904085|NCT04340063|147338397|OTHER||Slope|-52.0||||0.9|TWO_SIDED|95.0|-651.0|456.0||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||456|-651|0.9
73904086|NCT04340063|147338397|OTHER||Slope|79.0||||0.8|TWO_SIDED|95.0|-622.0|780.0||Interaction effect of time by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||780|-622|0.8
73904087|NCT01876810|147338415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1|TWO_SIDED|95.0||||For all analyses, results are considered significant at p\<.05.|t-test, 2 sided|||||||0.1
73904088|NCT01876810|147338415|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.1|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.1
74088288|NCT02709486|147730009|SUPERIORITY|||||||0.0007||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0007
73904089|NCT01876810|147338416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.034||0.9|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.9
73904090|NCT01876810|147338416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.05||0.9|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.9
73904091|NCT01876810|147338417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.3|STANDARD_ERROR_OF_MEAN|31.7||0.4|TWO_SIDED|95.0|||||ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used|participants self-reportd VAS craving at the time of neutral cue presentation|||||0.4
73904092|NCT01876810|147338417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.7|STANDARD_ERROR_OF_MEAN|26.5||0.4|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used||||||0.4
73904093|NCT03332771|147338452|NON_INFERIORITY|The non-inferiority hypothesis was declared significant if the upper bound of the 2-sided 95% confidence interval (CI) for the adjusted mean difference is \<0.3.|Difference in Least Squares (LS) Mean|0.12|STANDARD_ERROR_OF_MEAN|0.122||0.3306|TWO_SIDED|95.0|-0.12|0.357|||ANCOVA|||The change from baseline to Week 52 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.357|-0.120|0.3306
73971054|NCT02969707|147482294|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable.||||||0.023|||||||Regression, Linear|(R² = .104, F(2,48) = 2.794, β = .320, p = .023)||In people with FMS, the linear relationship between Thermal Pain Tolerance and E/I ratio as it relates to water was assessed.||||0.023
73971055|NCT02969707|147482294|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable.||||||0.043|||||||Regression, Linear|(R² = .081, F(1,49) = 4.315, β = .284, p = .043)||In people with FMS, the linear relationship between Thermal Pain Threshold and E/I ratio as it relates to water was assessed.||||0.043
73904094|NCT03332771|147338452|NON_INFERIORITY|The non-inferiority hypothesis was declared significant if the upper bound of the 2-sided 95% CI for the adjusted mean difference is \<0.3.|Difference in LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.114||0.7112|TWO_SIDED|95.0|-0.265|0.181|||ANCOVA|||The change from baseline to Week 52 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.181|-0.265|0.7112
73904095|NCT03332771|147338453|SUPERIORITY||Difference in LS Mean|-0.21|STANDARD_ERROR_OF_MEAN|0.119||0.0827|TWO_SIDED|95.0|-0.44|0.027|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.027|-0.440|0.0827
73904096|NCT03332771|147338453|SUPERIORITY||Difference in LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.103||0.0003|TWO_SIDED|95.0|-0.571|-0.167|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.167|-0.571|0.0003
73904097|NCT03332771|147338454|SUPERIORITY||Difference in LS Mean|-1.49|STANDARD_ERROR_OF_MEAN|0.349|<|0.0001|TWO_SIDED|95.0|-2.173|-0.803|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups (placebo, sotagliflozin 200 mg, sotagliflozin 400 mg, glimepiride), randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of SBP (\<130,≥ 130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||-0.803|-2.173|<0.0001
73904098|NCT03332771|147338454|SUPERIORITY||Difference in LS Mean|-3.58|STANDARD_ERROR_OF_MEAN|0.544|<|0.0001|TWO_SIDED|95.0|-4.651|-2.517|||ANCOVA|||The change from baseline to Week 52 is analyzed using analysis of ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects and baseline body weight as a covariate.||-2.517|-4.651|< 0.0001
73904099|NCT03332771|147338455|SUPERIORITY||Difference in LS Mean|-4.18|STANDARD_ERROR_OF_MEAN|1.288||0.0012|TWO_SIDED|95.0|-6.701|-1.65|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.650|-6.701|0.0012
73904100|NCT03332771|147338455|SUPERIORITY||Difference in LS Mean|-2.7|STANDARD_ERROR_OF_MEAN|0.0973||0.0973|TWO_SIDED|95.0|-5.89|0.491|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.491|-5.890|0.0973
73904101|NCT03332771|147338456|SUPERIORITY||Difference in LS Mean|-4.02|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|-5.73|-2.319|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-2.319|-5.730|<0.0001
73904102|NCT03332771|147338457|SUPERIORITY||Percentage difference|-15.4|||<|0.0001|TWO_SIDED|95.0|-19.67|-11.12|||Cochran-Mantel-Haenszel|||Weighted average of percentage difference between treatment groups from each stratum \[randomization strata of HbA1c \[≤8.5%, \>8.5%\] at screening, randomization strata of mean SBP \[\<130, ≥130 mmHg\] at screening using Cochran-Mantel-Haenszel weights.||-11.12|-19.67|<0.0001
73904103|NCT05523323|147338516|OTHER||Estimate difference|29.5||||0.0002014|TWO_SIDED|95.0|14.0|43.9|||Unstratified Miettinen & Nurminen method|One-sided p-value was calculated using the unstratified Miettinen \& Nurminen method.|The exact binomial method by Clopper and Pearson was used to generate the estimate difference and the associated 95% confidence intervals (CIs).|||43.9|14.0|0.0002014
74088289|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.59|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.59|0.29|<.0001
73904104|NCT05523323|147338517|OTHER||Hazard Ratio (HR)|0.34||||3.7e-06|TWO_SIDED|95.0|0.21|0.55|||unstratified Log-rank test.|One-sided p-value was calculated using unstratified Log-rank test.|The unstratified Cox-Regression model with Efron's method of tie handling with treatment as covariate was used to generate Hazard Ratio (HR) and the associated 95%CI.|||0.55|0.21|0.0000037
73904105|NCT05523323|147338518|OTHER||Hazard Ratio (HR)|0.86||||0.30933|TWO_SIDED|95.0|0.49|1.54|||Unstratified Log-rank test|One-sided p-value was calculated using unstratified Log-rank test.|The unstratified Cox-Regression model with Efron's method of tie handling with treatment as covariate was used to generate Hazard Ratio (HR) and the associated 95%CI.|||1.54|0.49|0.30933
73904106|NCT01948310|147338537|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
73904107|NCT01948310|147338537|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||0-14 weeks||||0.03
73904108|NCT01948310|147338537|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
73904109|NCT01948310|147338537|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||14-0 weeks||||0.005
73904110|NCT01948310|147338538|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
73904111|NCT01948310|147338538|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks||||>0.05
73904112|NCT01948310|147338538|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||2-0 weeks||||0.03
73904113|NCT01948310|147338538|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks||||>0.05
73904114|NCT01948310|147338539|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
73904115|NCT01948310|147338539|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||0-14 weeks||||0.13
73904116|NCT01948310|147338539|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
73904117|NCT01948310|147338539|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||14-0 weeks||||0.013
73904118|NCT00920829|147338548|SUPERIORITY|||||||0.724|||||||Mixed Models Analysis|||A linear mixed model with unstructured variance/covariance matrices was used to evaluate the primary outcome measure.||||0.724
74088290|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|0.55||||0.001|TWO_SIDED|95.0|0.38|0.78|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.78|0.38|0.0010
73904119|NCT00920829|147338548|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||This is a test of the main effect of medication, with a null hypothesis of no difference between Naltrexone and Placebo groups.||||0.023
73904120|NCT05654441|147338552|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73904121|NCT05654441|147338553|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73904122|NCT05654441|147338554|OTHER|||||||0.007|||||||ANOVA|||||||0.007
73904123|NCT05654441|147338555|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73904124|NCT05654441|147338556|OTHER|||||||0.886|||||||t-test, 2 sided|||||||0.886
73904125|NCT05654441|147338557|OTHER|||||||0.666|||||||t-test, 2 sided|||||||.666
73904126|NCT05654441|147338558|OTHER|||||||0.522|||||||t-test, 2 sided|||||||.522
73904127|NCT05654441|147338559|OTHER|||||||0.438|||||||t-test, 2 sided|||||||.438
73904128|NCT05654441|147338560|OTHER|||||||0.181|||||||t-test, 2 sided|||||||.181
73904129|NCT05654441|147338561|OTHER|||||||0.833|||||||t-test, 2 sided|||||||.833
73904130|NCT05654441|147338562|OTHER|||||||0.455|||||||t-test, 2 sided|||||||.455
73904131|NCT03718871|147338607|SUPERIORITY||intracluster correlation coefficient|0.086|||<|0.001|TWO_SIDED|95.0|0.015|0.363||The threshold for significance was set at p \< 0.05.|Fisher Exact|||Given that the intervention arm showed 100% uptake, a multi-level regression model could not be created with a zero in the denominator in the intervention group. We therefore used Fisher's exact test to assess for significant differences in proportion of HIV testing between study arms.||0.363|0.015|<0.001
73904132|NCT03718871|147338608|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
73904133|NCT03718871|147338609|SUPERIORITY|||||||0.015|||||||Fisher Exact|||||||0.015
73904134|NCT03718871|147338610|OTHER|No comparison between study arm groups was made in this analysis, as it was limited to control arm only.|Odds Ratio (OR)|1.04|STANDARD_DEVIATION|0.039|<|0.01|TWO_SIDED|95.0|1.02|1.06||Significance threshold two-sided alpha = 0.05|Regression, Linear|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.06|1.02|<0.01
73904135|NCT03718871|147338611|OTHER|No comparison was made with the intervention arm|Odds Ratio (OR)|0.56||||0.07|TWO_SIDED|95.0|0.3|1.04||Univariate analysis|Fisher Exact|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.04|0.30|0.07
73904136|NCT03718871|147338612|OTHER|Comparison between study arms was not performed|Odds Ratio (OR)|0.43||||0.09|TWO_SIDED|95.0|0.16|1.18|||Fisher Exact|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.18|0.16|0.09
73904137|NCT00905827|147338640|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores||||<0.01
73904138|NCT00905827|147338640|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores||||0.01
73904139|NCT00509392|147338642|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73904140|NCT00509392|147338643|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73904141|NCT00509392|147338644|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73904142|NCT00509392|147338645|SUPERIORITY_OR_OTHER|||||||0.2962||95.0|||||t-test, 2 sided|||||||0.2962
73904143|NCT00509392|147338646|SUPERIORITY_OR_OTHER|||||||0.0048||95.0|||||t-test, 2 sided|||||||0.0048
73904144|NCT00509392|147338647|SUPERIORITY_OR_OTHER|||||||0.0036||95.0|||||t-test, 2 sided|||||||0.0036
73904145|NCT00509392|147338648|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||t-test, 2 sided|||||||0.0005
73904146|NCT00509392|147338649|SUPERIORITY_OR_OTHER|||||||0.5761||95.0|||||t-test, 2 sided|||||||0.5761
73904147|NCT00509392|147338650|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73904148|NCT00509392|147338651|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73904149|NCT00509392|147338652|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73904150|NCT00509392|147338653|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Fisher Exact|||||||0.0050
73904151|NCT00509392|147338655|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||t-test, 2 sided|||||||0.0009
73904152|NCT00509392|147338656|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
73904153|NCT00509392|147338657|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||t-test, 2 sided|||||||0.0035
73904154|NCT00509392|147338658|SUPERIORITY_OR_OTHER|||||||0.2825||95.0|||||t-test, 2 sided|||||||0.2825
73904155|NCT00509392|147338659|SUPERIORITY_OR_OTHER|||||||0.0854||95.0|||||t-test, 2 sided|||||||0.0854
73904156|NCT00509392|147338660|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||t-test, 2 sided|||||||0.0044
73904157|NCT00509392|147338661|SUPERIORITY_OR_OTHER|||||||0.0457||95.0|||||t-test, 2 sided|||||||0.0457
73904158|NCT00509392|147338662|SUPERIORITY_OR_OTHER|||||||0.9463||95.0|||||t-test, 2 sided|||||||0.9463
73904159|NCT03954041|147338664|SUPERIORITY||LS mean difference|4.62|||=|0.3752|TWO_SIDED|95.0|-5.74|14.98||P-value was analyzed by ANCOVA model with covariates: treatment, interactive response technology (IRT) stratification factors at randomization, baseline total contusion volume based on central read, imaging modality at Hour 96 (MRI vs NCCT).|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||14.98|-5.74|= 0.3752
73904160|NCT03954041|147338665|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.4|3.36||||||Statistical analysis of combined BIIB093 vs placebo||3.36|0.40|
73904161|NCT03954041|147338666|SUPERIORITY||Odds Ratio (OR)|1.47|||=|0.4306|TWO_SIDED|95.0|0.56|3.86||P-value was analyzed by ordinal logistic regression on mRS adjusting for covariates: treatment, IRT stratification factors at randomization, baseline mRS score, and baseline total contusion volume based on central read.|Regression, Logistic|||Statistical analysis of combined BIIB093 vs placebo||3.86|0.56|=0.4306
73904162|NCT03954041|147338668|SUPERIORITY||LS Mean difference|-1.53|||=|0.6478|TWO_SIDED|95.0|-8.19|5.13||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline total contusion volume based on central read.|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||5.13|-8.19|= 0.6478
73904163|NCT03954041|147338669|SUPERIORITY||LS Mean Difference|-0.09|||=|0.9314|TWO_SIDED|95.0|-2.2|2.02||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline Glasgow Coma Scale (GCS) based on eCRF, and baseline absolute hematoma volume based on central read.|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||2.02|-2.20|=0.9314
73904164|NCT03954041|147338670|SUPERIORITY||LS Mean difference|2.18|||=|0.6569|TWO_SIDED|95.0|-7.61|11.98||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline absolute edema volume based on central read, baseline GCS based on eCRF, and imaging modality at Hour 96 (MRI vs NCCT).|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||11.98|-7.61|= 0.6569
73904165|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.25|||||TWO_SIDED|95.0|-1.99|-0.5||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.50|-1.99|
73904166|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.88|-0.52||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.52|-1.88|
73930718|NCT03238911|147391297|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.0016|TWO_SIDED|95.0|0.19|0.77|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.77|0.19|0.0016
74024870|NCT01309737|147602228|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-7.14|-5.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-5.05|-7.14|<0.0001
74024871|NCT01309737|147602228|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.43||0.0002|TWO_SIDED|95.0|-2.48|-0.79|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.79|-2.48|0.0002
74084928|NCT02212457|147723501|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.53|1.02|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain M14459 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||1.02|0.53|
73930719|NCT03238911|147391297|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.0185|TWO_SIDED|95.0|0.07|0.76|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.76|0.07|0.0185
73930720|NCT03238911|147391298|SUPERIORITY||Mean Difference (Final Values)|-14.84||||0.1922|TWO_SIDED|95.0|-37.26|7.57|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||7.57|-37.26|0.1922
73930721|NCT03238911|147391298|SUPERIORITY||Mean Difference (Final Values)|-18.28||||0.5601|TWO_SIDED|95.0|-80.24|43.68|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||43.68|-80.24|0.5601
73904167|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.76|0.69||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.69|-0.76|
73904168|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|-0.37|1.01||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 10AM Difference between Implant Group 2 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.01|-0.37|
73904169|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.59|0.91||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.91|-0.59|
73904170|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.77|0.71||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.71|-0.77|
73904171|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.84|-0.36||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 8AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.36|-1.84|
73904172|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-1.13|||||TWO_SIDED|95.0|-1.81|-0.45||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 10AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.45|-1.81|
73904173|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.33|||||TWO_SIDED|95.0|-0.39|1.06||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 8AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.06|-0.39|
73904174|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|-0.46|0.93||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 10AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.93|-0.46|
73962513|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.09||0.0137|TWO_SIDED|95.0|-0.42|-0.05|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.42|0.0137
74084929|NCT02212457|147723501|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.54|0.94|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain M07-0241084 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.94|0.54|
73853760|NCT01942668|147255551|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.001
73853761|NCT01942668|147255551|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||0.015
73853762|NCT01942668|147255551|SUPERIORITY|||||||0.005||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.005
73853763|NCT01942668|147255552|SUPERIORITY|||||||0.523||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.523
73853764|NCT01942668|147255552|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
73853765|NCT01942668|147255552|SUPERIORITY|||||||0.821||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.821
73853766|NCT01942668|147255552|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
73853767|NCT01942668|147255552|SUPERIORITY|||||||0.828||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.828
73853768|NCT01942668|147255552|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
73853769|NCT01942668|147255552|SUPERIORITY|||||||0.239||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.239
73853770|NCT01942668|147255552|SUPERIORITY|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.377
73853771|NCT01942668|147255553|SUPERIORITY|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.036
73853772|NCT01942668|147255553|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.015
73853773|NCT01942668|147255553|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||1.000
73904175|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.53|||||TWO_SIDED|95.0|-0.23|1.28||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 8AM Difference between Implant Group 1 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.28|-0.23|
73904176|NCT03868124|147338672|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-0.19|1.29||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 1 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.29|-0.19|
73904177|NCT00433511|147338681|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.17|TWO_SIDED|95.0|0.71|1.06||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A|The primary objective of this trial was to determine whether the addition of bevacizumab improved IDFS. A two-step hierarchical approach was used. In the 1st step, Arm C was to be compared to Arm A. If Arm C significantly improved IDFS relative to Arm A, then in the 2nd step, a comparison of Arm B to Arm A was to be performed. If the treatment in both Arm C and Arm B significantly improved IDFS relative to Arm A, then a comparison of Arm C to Arm B was to be performed with respect to IDFS.||1.06|0.71|0.17
73904178|NCT00433511|147338682|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.41|TWO_SIDED|95.0|0.68|1.17||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A|||1.17|0.68|0.41
73904179|NCT00433511|147338682|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.92|TWO_SIDED|95.0|0.77|1.33||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm B/Arm A|||1.33|0.77|0.92
73904180|NCT00433511|147338682|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.36|TWO_SIDED|95.0|0.72|1.13||Two-sided; based on stratified test using stratification factors at randomization|Regression, Cox||Hazard ratio: Arm C/Arm B|||1.13|0.72|0.36
73904181|NCT02840240|147338693|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Mean Difference (Final Values)|-0.19||||0.003|TWO_SIDED|95.0|-1.07|0.69|||Regression, Linear|||||0.69|-1.07|0.003
73904182|NCT02840240|147338694|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Ratio of geometric means|2.12||||0.77|TWO_SIDED|95.0|0.21|18.54|||Regression, Linear|||Comparisons of opioid consumption were conducted independently for each study site. This analysis is for patients at the Cleveland Clinic main campus.||18.54|0.21|0.77
74088291|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.7|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.70|0.36|<.0001
74088292|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|0.62||||0.0067|TWO_SIDED|95.0|0.44|0.88|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.88|0.44|0.0067
73853774|NCT01942668|147255553|SUPERIORITY|||||||0.546||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.546
73904183|NCT02840240|147338694|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Ratio of geometric means|0.32||||0.09|TWO_SIDED|95.0|0.03|3.16|||Regression, Linear|||Comparisons of opioid consumption were conducted independently for each study site. This analysis is for patients at the Cleveland Clinic Fairview hospital.||3.16|0.03|0.09
73904184|NCT02840240|147338695|SUPERIORITY||Odds Ratio (OR)|3.5||||0.11|TWO_SIDED|98.75|0.5|24.3|||Regression, Logistic|||||24.3|0.5|0.11
73904185|NCT02840240|147338696|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6|TWO_SIDED|98.75|0.2|3.1|||Regression, Logistic|||||3.1|0.2|0.60
73904186|NCT03355664|147338758|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.38|TWO_SIDED|95.0|0.2|1.9|||Regression, Cox|||||1.9|0.2|0.38
73904187|NCT01858636|147338795|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||Fisher Exact|A one-sided Fisher's exact test was performed with a 95% upper confidence bound of 5.5%||Ho: Pt ≥ 8% Ha: Pt \< 8%, where Pt is the proportion of deployed subjects with a protocol-defined vascular complication.||||0.0029
73904188|NCT01858636|147338796|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|A one-sided Fisher's exact test was performed with a 95% lower confidence bound of 96.4%||Ho: St ≤ 90% Ha: St \> 90%, where St is the proportion of deployed subjects achieving hemostasis within 5 minutes.||||<0.0001
73853775|NCT01942668|147255553|SUPERIORITY|||||||0.352||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.352
73853776|NCT01942668|147255553|SUPERIORITY|||||||0.261||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.261
73853777|NCT01942668|147255553|SUPERIORITY|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.058
73853778|NCT01942668|147255553|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.011
73853779|NCT01942668|147255554|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||<0.001
73853780|NCT01942668|147255554|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||<0.001
73853781|NCT01942668|147255554|SUPERIORITY|||||||0.115||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.115
73853782|NCT01942668|147255554|SUPERIORITY|||||||0.11||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.110
73853783|NCT01942668|147255554|SUPERIORITY|||||||0.089||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.089
73853784|NCT01942668|147255554|SUPERIORITY|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.074
73853785|NCT01942668|147255554|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.011
73853786|NCT01942668|147255554|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.008
73853787|NCT01942668|147255555|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
73853788|NCT01942668|147255555|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
73853789|NCT01942668|147255555|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.011
73853790|NCT01942668|147255555|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
73853791|NCT01942668|147255555|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.002
73853792|NCT01942668|147255555|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.002
73853793|NCT01942668|147255555|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
73853794|NCT01942668|147255555|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
73853795|NCT01942668|147255556|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||<0.001
73853796|NCT01942668|147255556|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||<0.001
73853797|NCT01942668|147255556|SUPERIORITY|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.048
73962514|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0106|TWO_SIDED|95.0|-0.43|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.43|0.0106
73904189|NCT01227564|147338822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.9538|TWO_SIDED|95.0|-0.075|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.071|-0.075|0.9538
73904190|NCT01227564|147338822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.8787|TWO_SIDED|95.0|-0.07|0.081||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.081|-0.070|0.8787
73904191|NCT01227564|147338822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002||||0.9544|TWO_SIDED|95.0|-0.062|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.066|-0.062|0.9544
73904192|NCT01227564|147338822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.955|TWO_SIDED|95.0|-0.106|0.112||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.112|-0.106|0.9550
73904193|NCT01227564|147338822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.8874|TWO_SIDED|95.0|-0.121|0.105||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.105|-0.121|0.8874
73904194|NCT01227564|147338822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.9595|TWO_SIDED|95.0|-0.099|0.095||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.095|-0.099|0.9595
73904195|NCT01227564|147338822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.3826|TWO_SIDED|95.0|-0.164|0.064||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.064|-0.164|0.3826
73930722|NCT03238911|147391298|SUPERIORITY||Mean Difference (Final Values)|-71.02||||0.0459|TWO_SIDED|95.0|-140.74|-1.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-1.30|-140.74|0.0459
73962515|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7179|TWO_SIDED|95.0|-0.23|0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.23|0.7179
73962516|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|95.0|-0.44|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.44|0.0120
73962517|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.11||0.5372|TWO_SIDED|95.0|-0.28|0.15|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.28|0.5372
74088293|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|0.64||||0.0087|TWO_SIDED|95.0|0.45|0.89|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.89|0.45|0.0087
73853798|NCT01942668|147255556|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.006
73853799|NCT01942668|147255556|SUPERIORITY|||||||0.063||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.063
73853800|NCT01942668|147255556|SUPERIORITY|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.058
73853801|NCT01942668|147255556|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.004
73853802|NCT01942668|147255556|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.003
73853803|NCT01942668|147255557|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
73853804|NCT01942668|147255557|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||<0.001
73853805|NCT01942668|147255557|SUPERIORITY|||||||0.05||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.050
73853806|NCT01942668|147255557|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.006
73853807|NCT01942668|147255557|SUPERIORITY|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.048
73853808|NCT01942668|147255557|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.004
73853809|NCT01942668|147255557|SUPERIORITY|||||||0.02||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.020
73853810|NCT01942668|147255557|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.001
73853811|NCT01942668|147255558|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
73853812|NCT01942668|147255558|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
73853813|NCT01942668|147255558|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.001
73853814|NCT01942668|147255558|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
73853815|NCT01942668|147255558|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.006
73853816|NCT01942668|147255558|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
73853817|NCT01942668|147255558|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
73853818|NCT01942668|147255558|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
73853819|NCT01942668|147255559|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||<0.001
73853820|NCT01942668|147255559|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
73853821|NCT01942668|147255559|SUPERIORITY|||||||0.013||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.013
73904196|NCT01227564|147338822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049||||0.3912|TWO_SIDED|95.0|-0.164|0.065||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.065|-0.164|0.3912
73904197|NCT01227564|147338822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.3221|TWO_SIDED|95.0|-0.149|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.050|-0.149|0.3221
73904198|NCT01227564|147338823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.18||||0.9384|TWO_SIDED|95.0|-1197.07|1293.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||Analysis of Covariance (ANCOVA) was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1293.42|-1197.07|0.9384
73904199|NCT01227564|147338823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|581.98||||0.3945|TWO_SIDED|95.0|-778.17|1942.13||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1942.13|-778.17|0.3945
73904200|NCT01227564|147338823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|315.08||||0.5773|TWO_SIDED|95.0|-812.15|1442.3||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1442.30|-812.15|0.5773
73904201|NCT01227564|147338824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.16||||0.5818|TWO_SIDED|95.0|-63.31|111.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||111.62|-63.31|0.5818
73904202|NCT01227564|147338824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|84.42||||0.0648|TWO_SIDED|95.0|-5.37|174.21||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||174.21|-5.37|0.0648
73904203|NCT01227564|147338824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.29||||0.1672|TWO_SIDED|95.0|-23.47|132.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||132.05|-23.47|0.1672
73904204|NCT01227564|147338825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36||||0.3106|TWO_SIDED|95.0|-9.94|3.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||3.22|-9.94|0.3106
73904205|NCT01227564|147338825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51||||0.1876|TWO_SIDED|95.0|-11.28|2.27||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||2.27|-11.28|0.1876
73904206|NCT01227564|147338825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.93||||0.1742|TWO_SIDED|95.0|-9.66|1.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1.79|-9.66|0.1742
73904207|NCT01227564|147338826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.36||||0.4089|TWO_SIDED|95.0|-103.52|42.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||42.81|-103.52|0.4089
73904208|NCT01227564|147338826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.4||||0.0327|TWO_SIDED|95.0|-159.69|-7.11||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||-7.11|-159.69|0.0327
73853822|NCT01942668|147255559|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
73853823|NCT01942668|147255559|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.001
73853824|NCT01942668|147255559|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.004
73853825|NCT01942668|147255559|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.003
73853826|NCT01942668|147255559|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.001
73853827|NCT01942668|147255560|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
73853828|NCT01942668|147255560|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
73904209|NCT01227564|147338826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.88||||0.0801|TWO_SIDED|95.0|-120.82|7.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||7.06|-120.82|0.0801
73853829|NCT01942668|147255560|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
73853830|NCT01942668|147255560|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
73853831|NCT01942668|147255560|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.001
73853832|NCT01942668|147255560|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
73853833|NCT01942668|147255560|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.004
73853834|NCT01942668|147255560|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
73853835|NCT01942668|147255561|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
73853836|NCT01942668|147255561|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
73853837|NCT01942668|147255561|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
73853838|NCT01942668|147255561|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
73853839|NCT01942668|147255561|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
73853840|NCT01942668|147255561|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
73853841|NCT01942668|147255561|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.001
73853842|NCT01942668|147255561|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
73853843|NCT01942668|147255562|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
73853844|NCT01942668|147255562|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
73853845|NCT01942668|147255562|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
73853846|NCT01942668|147255562|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
73853847|NCT01942668|147255562|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
73853848|NCT01942668|147255562|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||0.003
73853849|NCT01942668|147255562|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
73853850|NCT01942668|147255562|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
73853851|NCT01942668|147255563|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
73904210|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.78||||0.4892|TWO_SIDED|95.0|-37.15|76.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||76.71|-37.15|0.4892
73904211|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.06||||0.0915|TWO_SIDED|95.0|-8.51|110.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||110.63|-8.51|0.0915
73904212|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.42||||0.1638|TWO_SIDED|95.0|-14.88|85.72||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||85.72|-14.88|0.1638
73904213|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.29||||0.2006|TWO_SIDED|95.0|-54.28|252.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||252.86|-54.28|0.2006
73904214|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|225.63||||0.0067|TWO_SIDED|95.0|65.18|386.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||386.09|65.18|0.0067
73904215|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|162.46||||0.0204|TWO_SIDED|95.0|26.05|298.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||298.87|26.05|0.0204
73904216|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|114.13||||0.0766|TWO_SIDED|95.0|-12.63|240.89||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||240.89|-12.63|0.0766
73904217|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.82||||0.0181|TWO_SIDED|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||413.41|40.23|0.0181
73904218|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|167.33||||0.0387|TWO_SIDED|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||325.63|9.03|0.0387
73904219|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|107.84||||0.2277|TWO_SIDED|95.0|-69.29|284.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||284.97|-69.29|0.2277
74084930|NCT02212457|147723501|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.51|0.85|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain 96217 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.85|0.51|
73853852|NCT01942668|147255563|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
73853853|NCT01942668|147255563|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
73853854|NCT01942668|147255563|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
73853855|NCT01942668|147255563|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
73904220|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.82||||0.0181|TWO_SIDED|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||413.41|40.23|0.0181
73904221|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|167.33||||0.0387|TWO_SIDED|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||325.63|9.03|0.0387
73904222|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|141.92||||0.0747|TWO_SIDED|95.0|-14.62|298.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||298.45|-14.62|0.0747
73904223|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|204.4||||0.0151|TWO_SIDED|95.0|41.02|367.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||367.79|41.02|0.0151
73930723|NCT03238911|147391298|SUPERIORITY||Mean Difference (Final Values)|-207.33|||<|0.0001|TWO_SIDED|95.0|-268.82|-145.84|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-145.84|-268.82|<0.0001
73853856|NCT01942668|147255563|SUPERIORITY|||||||0.056||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.056
73853857|NCT01942668|147255563|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
73853858|NCT01942668|147255563|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.017
73853859|NCT01942668|147255564|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||||||<0.001
73853860|NCT01942668|147255564|SUPERIORITY|||||||0.005||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||||||0.005
73853861|NCT01942668|147255564|SUPERIORITY|||||||0.007||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.007
73853862|NCT01942668|147255564|SUPERIORITY|||||||0.004||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.004
73853863|NCT01942668|147255566|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||||||<0.001
73853864|NCT01942668|147255566|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||||||<0.001
73904224|NCT01227564|147338827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|173.16||||0.0161|TWO_SIDED|95.0|33.25|313.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||313.07|33.25|0.0161
73904225|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.652||||0.1807|TWO_SIDED|95.0|-6.57|1.267||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||1.267|-6.570|0.1807
73904226|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.497||||0.8051|TWO_SIDED|95.0|-3.515|4.508||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||4.508|-3.515|0.8051
73904227|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.078||||0.5331|TWO_SIDED|95.0|-4.519|2.364||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||2.364|-4.519|0.5331
73904228|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.9274|TWO_SIDED|95.0|-3.99|3.641||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||3.641|-3.990|0.9274
73904229|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.549||||0.0743|TWO_SIDED|95.0|-0.36|7.458||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||7.458|-0.360|0.0743
74084931|NCT02212457|147723501|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.49|||||TWO_SIDED|95.0|0.37|0.66|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain NZ98/254 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.66|0.37|
73904230|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.687||||0.3163|TWO_SIDED|95.0|-1.656|5.031||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||5.031|-1.656|0.3163
73904231|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.645||||0.519|TWO_SIDED|95.0|-6.721|3.43||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||3.430|-6.721|0.5190
73904232|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.758||||0.074|TWO_SIDED|95.0|-0.476|9.991||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||9.991|-0.476|0.0740
74024872|NCT01309737|147602229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.0001|TWO_SIDED|95.0|1.89|8.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||8.95|1.89|<.0001
74024873|NCT01309737|147602229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.25|||<|0.0001|TWO_SIDED|95.0|4.08|19.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||19.95|4.08|<.0001
73962518|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.0899|TWO_SIDED|95.0|-0.4|0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.40|0.0899
73962519|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7646|TWO_SIDED|95.0|-0.3|0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.30|0.7646
73853865|NCT01942668|147255566|SUPERIORITY|||||||0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||||||0.001
73853866|NCT01942668|147255566|SUPERIORITY|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||||||0.002
73853867|NCT01942668|147255568|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
73853868|NCT01942668|147255568|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
73853869|NCT01942668|147255568|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
73853870|NCT01942668|147255568|SUPERIORITY|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||||||0.002
73853871|NCT01942668|147255570|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
73853872|NCT01942668|147255570|SUPERIORITY|||||||0.122|||||||Fisher Exact|||||||0.122
73853873|NCT01942668|147255570|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.280
73853874|NCT01942668|147255570|SUPERIORITY|||||||0.692|||||||Fisher Exact|||||||0.692
73853875|NCT01942668|147255571|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
73853876|NCT01942668|147255571|SUPERIORITY|||||||0.069|||||||Fisher Exact|||||||0.069
73853877|NCT01942668|147255571|SUPERIORITY|||||||0.131|||||||Fisher Exact|||||||0.131
73853878|NCT01942668|147255571|SUPERIORITY|||||||0.661|||||||Fisher Exact|||||||0.661
73853879|NCT01942668|147255572|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
73853880|NCT01942668|147255572|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.040
73853881|NCT01942668|147255572|SUPERIORITY|||||||0.082|||||||Fisher Exact|||||||0.082
73853882|NCT01942668|147255572|SUPERIORITY|||||||0.495|||||||Fisher Exact|||||||0.495
73853883|NCT01942668|147255573|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
73853884|NCT01942668|147255573|SUPERIORITY|||||||0.032|||||||Fisher Exact|||||||0.032
73853885|NCT01942668|147255573|SUPERIORITY|||||||0.137|||||||Fisher Exact|||||||0.137
73853886|NCT01942668|147255573|SUPERIORITY|||||||0.792|||||||Fisher Exact|||||||0.792
73853887|NCT01942668|147255574|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
73853888|NCT01942668|147255574|SUPERIORITY|||||||0.067|||||||Fisher Exact|||||||0.067
73853889|NCT01942668|147255574|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.260
73853890|NCT01942668|147255574|SUPERIORITY|||||||0.792|||||||Fisher Exact|||||||0.792
73853891|NCT01942668|147255575|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
73853892|NCT01942668|147255575|SUPERIORITY|||||||0.095|||||||Fisher Exact|||||||0.095
73853893|NCT01942668|147255575|SUPERIORITY|||||||0.352|||||||Fisher Exact|||||||0.352
73853894|NCT01942668|147255575|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73853895|NCT01942668|147255576|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
73853896|NCT01942668|147255576|SUPERIORITY|||||||0.075|||||||Fisher Exact|||||||0.075
73853897|NCT01942668|147255576|SUPERIORITY|||||||0.225|||||||Fisher Exact|||||||0.225
73853898|NCT01942668|147255576|SUPERIORITY|||||||0.769|||||||Fisher Exact|||||||0.769
73962520|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2547|TWO_SIDED|95.0|-0.41|0.11|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.41|0.2547
73962521|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8806|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.29|0.8806
74024874|NCT01309737|147602229|SUPERIORITY_OR_OTHER||Percent difference|10.79|STANDARD_ERROR_OF_MEAN|3.02||0.0004|TWO_SIDED|95.0|4.87|16.71|||Normal Approximation|||||16.71|4.87|0.0004
74084932|NCT00420095|147723525|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority hypothesis testing where paired t-test for equivalence of means was used to estimate the sample size.~Pre-defined non-inferiority margin of 0.3%."|Mean Difference (Net)|-0.05||||0.497||95.0|-0.2|0.1|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom. Adjusted means were presented.||Mixed model where period, sequence, treatment are fixed effects and patient within sequence are random effects.||0.10|-0.20|0.497
73853899|NCT01942668|147255577|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
73853900|NCT01942668|147255577|SUPERIORITY|||||||0.084|||||||Fisher Exact|||||||0.084
73853901|NCT01942668|147255577|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
73853902|NCT01942668|147255577|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
73853903|NCT01942668|147255578|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
73853904|NCT01942668|147255578|SUPERIORITY|||||||0.125|||||||Fisher Exact|||||||0.125
73853905|NCT01942668|147255578|SUPERIORITY|||||||0.386|||||||Fisher Exact|||||||0.386
73853906|NCT01942668|147255578|SUPERIORITY|||||||0.737|||||||Fisher Exact|||||||0.737
73853907|NCT01942668|147255579|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
73853908|NCT01942668|147255579|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
73853909|NCT01942668|147255579|SUPERIORITY|||||||0.745|||||||Fisher Exact|||||||0.745
73853910|NCT01942668|147255579|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73853911|NCT01942668|147255580|SUPERIORITY|||||||0.035|||||||Fisher Exact|||||||0.035
73853912|NCT01942668|147255580|SUPERIORITY|||||||0.536|||||||Fisher Exact|||||||0.536
73853913|NCT01942668|147255580|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73853914|NCT01942668|147255580|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73853915|NCT01942668|147255581|SUPERIORITY|||||||0.261|||||||Fisher Exact|||||||0.261
73853916|NCT01942668|147255581|SUPERIORITY|||||||0.536|||||||Fisher Exact|||||||0.536
73853917|NCT01942668|147255581|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73853918|NCT01942668|147255581|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73853919|NCT01942668|147255582|SUPERIORITY|||||||0.463|||||||Fisher Exact|||||||0.463
73853920|NCT01942668|147255582|SUPERIORITY|||||||0.687|||||||Fisher Exact|||||||0.687
73853921|NCT01942668|147255582|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73853922|NCT01942668|147255582|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73853923|NCT01942668|147255583|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73853924|NCT01942668|147255583|SUPERIORITY|||||||0.048|||||||Fisher Exact|||||||0.048
73853925|NCT01942668|147255583|SUPERIORITY|||||||0.049|||||||Fisher Exact|||||||0.049
73853926|NCT01942668|147255583|SUPERIORITY|||||||0.328|||||||Fisher Exact|||||||0.328
73853927|NCT01942668|147255584|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73853928|NCT01942668|147255584|SUPERIORITY|||||||0.123|||||||Fisher Exact|||||||0.123
73853929|NCT01942668|147255584|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.030
73853930|NCT01942668|147255584|SUPERIORITY|||||||0.649|||||||Fisher Exact|||||||0.649
73853931|NCT01942668|147255585|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73853932|NCT01942668|147255585|SUPERIORITY|||||||0.059|||||||Fisher Exact|||||||0.059
73853933|NCT01942668|147255585|SUPERIORITY|||||||0.023|||||||Fisher Exact|||||||0.023
73853934|NCT01942668|147255585|SUPERIORITY|||||||0.426|||||||Fisher Exact|||||||0.426
73853935|NCT01942668|147255586|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73853936|NCT01942668|147255586|SUPERIORITY|||||||0.044|||||||Fisher Exact|||||||0.044
73853937|NCT01942668|147255586|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
73853938|NCT01942668|147255586|SUPERIORITY|||||||0.481|||||||Fisher Exact|||||||0.481
73853939|NCT01942668|147255587|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73853940|NCT01942668|147255587|SUPERIORITY|||||||0.11|||||||Fisher Exact|||||||0.110
73853941|NCT01942668|147255587|SUPERIORITY|||||||0.045|||||||Fisher Exact|||||||0.045
73853942|NCT01942668|147255587|SUPERIORITY|||||||0.853|||||||Fisher Exact|||||||0.853
73853943|NCT01942668|147255588|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73853944|NCT01942668|147255588|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
73853945|NCT01942668|147255588|SUPERIORITY|||||||0.145|||||||Fisher Exact|||||||0.145
73853946|NCT01942668|147255588|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73853947|NCT01942668|147255589|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73853948|NCT01942668|147255589|SUPERIORITY|||||||0.163|||||||Fisher Exact|||||||0.163
73853949|NCT01942668|147255589|SUPERIORITY|||||||0.091|||||||Fisher Exact|||||||0.091
73853950|NCT01942668|147255589|SUPERIORITY|||||||0.693|||||||Fisher Exact|||||||0.693
73853951|NCT01942668|147255590|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73853952|NCT01942668|147255590|SUPERIORITY|||||||0.178|||||||Fisher Exact|||||||0.178
73853953|NCT01942668|147255590|SUPERIORITY|||||||0.097|||||||Fisher Exact|||||||0.097
73853954|NCT01942668|147255590|SUPERIORITY|||||||0.522|||||||Fisher Exact|||||||0.522
73853955|NCT01942668|147255591|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73853956|NCT01942668|147255591|SUPERIORITY|||||||0.315|||||||Fisher Exact|||||||0.315
73853957|NCT01942668|147255591|SUPERIORITY|||||||0.181|||||||Fisher Exact|||||||0.181
73853958|NCT01942668|147255591|SUPERIORITY|||||||0.821|||||||Fisher Exact|||||||0.821
73853959|NCT01942668|147255592|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73853960|NCT01942668|147255592|SUPERIORITY|||||||0.387|||||||Fisher Exact|||||||0.387
73853961|NCT01942668|147255592|SUPERIORITY|||||||0.215|||||||Fisher Exact|||||||0.215
73853962|NCT01942668|147255592|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.639
73853963|NCT01942668|147255593|SUPERIORITY|||||||0.008|||||||Fisher Exact|||||||0.008
73962522|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8416|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.30|0.8416
73853964|NCT01942668|147255593|SUPERIORITY|||||||0.643|||||||Fisher Exact|||||||0.643
73853965|NCT01942668|147255593|SUPERIORITY|||||||0.501|||||||Fisher Exact|||||||0.501
73853966|NCT01942668|147255593|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73853967|NCT01942668|147255594|SUPERIORITY|||||||0.013|||||||Fisher Exact|||||||0.013
74084933|NCT00420095|147723526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.497||95.0|-0.1|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.20|-0.10|0.497
73853968|NCT01942668|147255594|SUPERIORITY|||||||0.616|||||||Fisher Exact|||||||0.616
73853969|NCT01942668|147255594|SUPERIORITY|||||||0.352|||||||Fisher Exact|||||||0.352
73853970|NCT01942668|147255594|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73853971|NCT01942668|147255595|SUPERIORITY|||||||0.023|||||||Fisher Exact|||||||0.023
73853972|NCT01942668|147255595|SUPERIORITY|||||||0.535|||||||Fisher Exact|||||||0.535
73853973|NCT01942668|147255595|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
73853974|NCT01942668|147255595|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
73853975|NCT01942668|147255596|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||<0.001
73853976|NCT01942668|147255596|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.004
73853977|NCT01942668|147255596|SUPERIORITY|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.012
73853978|NCT01942668|147255596|SUPERIORITY|||||||0.032||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.032
73853979|NCT01942668|147255597|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||<0.001
73853980|NCT01942668|147255597|SUPERIORITY|||||||0.022||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||0.022
73853981|NCT01942668|147255597|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.004
73853982|NCT01942668|147255597|SUPERIORITY|||||||0.256||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.256
73853983|NCT01942668|147255598|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||<0.001
73853984|NCT01942668|147255598|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.006
73853985|NCT01942668|147255598|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.025
73853986|NCT01942668|147255598|SUPERIORITY|||||||0.182||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.182
73853987|NCT01942668|147255599|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.002
73853988|NCT01942668|147255599|SUPERIORITY|||||||0.469||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.469
73853989|NCT01942668|147255599|SUPERIORITY|||||||0.188||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||0.188
73853990|NCT01942668|147255599|SUPERIORITY|||||||0.613||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||0.613
73853991|NCT01942668|147255604|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.002
73853992|NCT01942668|147255604|SUPERIORITY|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.135
73853993|NCT01942668|147255604|SUPERIORITY|||||||0.26||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.260
73853994|NCT01942668|147255604|SUPERIORITY|||||||0.257||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.257
73853995|NCT01942668|147255605|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||<0.001
73962523|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.9981|TWO_SIDED|95.0|-0.28|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.28|-0.28|0.9981
73962524|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6485|TWO_SIDED|95.0|-0.21|0.34|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.34|-0.21|0.6485
73962525|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8317|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.30|0.8317
73962526|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5819|TWO_SIDED|95.0|-0.19|0.35|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.35|-0.19|0.5819
73962527|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8538|TWO_SIDED|95.0|-0.26|0.31|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.31|-0.26|0.8538
74084934|NCT00420095|147723527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.419||95.0|-0.48|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.20|-0.48|0.419
74084935|NCT00420095|147723528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.741||95.0|-1.09|0.78||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.78|-1.09|0.741
73853996|NCT01942668|147255605|SUPERIORITY|||||||0.085||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||0.085
73853997|NCT01942668|147255605|SUPERIORITY|||||||0.184||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.184
73853998|NCT01942668|147255605|SUPERIORITY|||||||0.681||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.681
73853999|NCT01942668|147255606|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.008
73854000|NCT01942668|147255606|SUPERIORITY|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.036
74084936|NCT00420095|147723529|SUPERIORITY_OR_OTHER|||||||0.644||95.0||||P-value for the HbA1c Percentage Criteria (7%)|Fisher Exact|||||||0.644
74084937|NCT00420095|147723529|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||P-value for the HbA1c Percentage Criteria (6.5%)|Fisher Exact|||||||0.672
74084938|NCT00420095|147723531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.67||95.0|-0.16|0.11||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.11|-0.16|0.670
74084939|NCT00393705|147723532|SUPERIORITY_OR_OTHER|||||||0.2519||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.2519
73854001|NCT01942668|147255606|SUPERIORITY|||||||0.138||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.138
73854002|NCT01942668|147255606|SUPERIORITY|||||||0.685||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.685
73854003|NCT01942668|147255607|SUPERIORITY|||||||0.023||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.023
73854004|NCT01942668|147255607|SUPERIORITY|||||||0.265||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.265
73854005|NCT01942668|147255607|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||1.000
73854006|NCT01942668|147255607|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||1.000
73854007|NCT01942668|147255612|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.246|<|0.001|TWO_SIDED|95.0|-2.13|-1.17||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.17|-2.13|<0.001
73854008|NCT01942668|147255612|SUPERIORITY||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|0.242|<|0.001|TWO_SIDED|95.0|-1.79|-0.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.84|-1.79|<0.001
73854009|NCT01942668|147255612|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.242|<|0.001|TWO_SIDED|95.0|-1.64|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.69|-1.64|<0.001
74024875|NCT01309737|147602230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.1786|TWO_SIDED|95.0|0.74|4.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||4.62|0.74|0.1786
73962528|NCT02528188|147460965|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.15||0.1981|TWO_SIDED|95.0|-0.1|0.47|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.47|-0.10|0.1981
73962529|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.0846|TWO_SIDED|95.0|-0.33|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.33|0.0846
73962530|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9749|TWO_SIDED|95.0|-0.18|0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.18|0.9749
74084940|NCT00393705|147723533|SUPERIORITY_OR_OTHER|||||||0.0287||95.0||||P-value for HbA1c \<7%. Additional statistically significant terms from the model below were baseline HbA1c and treatment by lead-in interaction.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).||||||0.0287
73854010|NCT01942668|147255612|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-1.51|-0.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.58|-1.51|<0.001
73854011|NCT01942668|147255613|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.258|<|0.001|TWO_SIDED|95.0|-1.91|-0.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.89|-1.91|<0.001
73854012|NCT01942668|147255613|SUPERIORITY||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.253|<|0.001|TWO_SIDED|95.0|-1.81|-0.82||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.82|-1.81|<0.001
73854013|NCT01942668|147255613|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.257|<|0.001|TWO_SIDED|95.0|-1.63|-0.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.62|-1.63|<0.001
73854014|NCT01942668|147255613|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.254||0.007|TWO_SIDED|95.0|-1.19|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.19|-1.19|0.007
73854015|NCT01942668|147255614|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-1.75|-0.66||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.66|-1.75|<0.001
73854016|NCT01942668|147255614|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|0.265|<|0.001|TWO_SIDED|95.0|-1.98|-0.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.94|-1.98|<0.001
73854017|NCT01942668|147255614|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.272|<|0.001|TWO_SIDED|95.0|-1.76|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.69|-1.76|<0.001
73854018|NCT01942668|147255614|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.272||0.008|TWO_SIDED|95.0|-1.26|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.19|-1.26|0.008
73854019|NCT01942668|147255615|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.161||0.284|TWO_SIDED|95.0|-0.49|0.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.49|0.284
73854020|NCT01942668|147255615|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.732|TWO_SIDED|95.0|-0.36|0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.26|-0.36|0.732
73854021|NCT01942668|147255615|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.159||0.437|TWO_SIDED|95.0|-0.44|0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.19|-0.44|0.437
73854022|NCT01942668|147255615|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.156||0.439|TWO_SIDED|95.0|-0.43|0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.19|-0.43|0.439
73854023|NCT01942668|147255616|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.169||0.04|TWO_SIDED|95.0|-0.68|-0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.02|-0.68|0.040
73854024|NCT01942668|147255616|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.165||0.066|TWO_SIDED|95.0|-0.63|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.02|-0.63|0.066
73854025|NCT01942668|147255616|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.168||0.469|TWO_SIDED|95.0|-0.45|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.21|-0.45|0.469
73854026|NCT01942668|147255616|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.166||0.616|TWO_SIDED|95.0|-0.41|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.41|0.616
73854027|NCT01942668|147255617|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.183||0.25|TWO_SIDED|95.0|-0.57|0.15||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.57|0.250
73854028|NCT01942668|147255617|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.175||0.002|TWO_SIDED|95.0|-0.88|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.20|-0.88|0.002
73854029|NCT01942668|147255617|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.179||0.796|TWO_SIDED|95.0|-0.4|0.31||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.31|-0.40|0.796
73854030|NCT01942668|147255617|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.179||0.955|TWO_SIDED|95.0|-0.36|0.34||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.34|-0.36|0.955
73854031|NCT01942668|147255618|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.143||0.474|TWO_SIDED|95.0|-0.38|0.18||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.18|-0.38|0.474
73854032|NCT01942668|147255618|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.378|TWO_SIDED|95.0|-0.4|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.15|-0.40|0.378
73854033|NCT01942668|147255618|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.141||0.018|TWO_SIDED|95.0|-0.61|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.61|0.018
73854034|NCT01942668|147255618|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.73|TWO_SIDED|95.0|-0.32|0.22||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.22|-0.32|0.730
73854035|NCT01942668|147255619|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.152||0.197|TWO_SIDED|95.0|-0.49|0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.10|-0.49|0.197
73854036|NCT01942668|147255619|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.148||0.308|TWO_SIDED|95.0|-0.44|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.14|-0.44|0.308
73854037|NCT01942668|147255619|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.152||0.117|TWO_SIDED|95.0|-0.54|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.06|-0.54|0.117
73854038|NCT01942668|147255619|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.149||0.739|TWO_SIDED|95.0|-0.34|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.34|0.739
73854039|NCT01942668|147255620|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.171||0.635|TWO_SIDED|95.0|-0.42|0.26||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.26|-0.42|0.635
73854040|NCT01942668|147255620|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.164||0.01|TWO_SIDED|95.0|-0.75|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.75|0.010
73854041|NCT01942668|147255620|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.169||0.092|TWO_SIDED|95.0|-0.62|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.05|-0.62|0.092
73854042|NCT01942668|147255620|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.168||0.243|TWO_SIDED|95.0|-0.53|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.13|-0.53|0.243
73854043|NCT01942668|147255621|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.21||0.049|TWO_SIDED|95.0|-0.83|0.0||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.00|-0.83|0.049
73854044|NCT01942668|147255621|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.206||0.773|TWO_SIDED|95.0|-0.34|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.46|-0.34|0.773
73854045|NCT01942668|147255621|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.208||0.081|TWO_SIDED|95.0|-0.77|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.05|-0.77|0.081
73854046|NCT01942668|147255621|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.204||0.625|TWO_SIDED|95.0|-0.5|0.3||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.30|-0.50|0.625
74084941|NCT00393705|147723533|SUPERIORITY_OR_OTHER|||||||0.0471||95.0||||P-value for HbA1c ≤6.5%. Additional statistically significant term from the model below was baseline HbA1c.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).||||||0.0471
74084942|NCT00393705|147723535|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0077
74084943|NCT00393705|147723536|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0002
74084944|NCT00393705|147723537|SUPERIORITY_OR_OTHER|||||||0.0129||95.0||||P-value for Fasting.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0129
73854047|NCT01942668|147255622|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.221||0.221|TWO_SIDED|95.0|-0.7|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.16|-0.70|0.221
73854048|NCT01942668|147255622|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.214||0.992|TWO_SIDED|95.0|-0.42|0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.42|-0.42|0.992
73854049|NCT01942668|147255622|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.219||0.181|TWO_SIDED|95.0|-0.72|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.14|-0.72|0.181
73854050|NCT01942668|147255622|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.216||0.846|TWO_SIDED|95.0|-0.47|0.38||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.38|-0.47|0.846
73854051|NCT01942668|147255623|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.257||0.421|TWO_SIDED|95.0|-0.71|0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.30|-0.71|0.421
73854052|NCT01942668|147255623|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.244||0.044|TWO_SIDED|95.0|-0.97|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.01|-0.97|0.044
73854053|NCT01942668|147255623|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.252||0.093|TWO_SIDED|95.0|-0.92|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.07|-0.92|0.093
73854054|NCT01942668|147255623|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.252||0.247|TWO_SIDED|95.0|-0.79|0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.20|-0.79|0.247
73854055|NCT01942668|147255624|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.145|<|0.001|TWO_SIDED|95.0|-0.87|-0.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.29|-0.87|<0.001
73854056|NCT01942668|147255624|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.143||0.016|TWO_SIDED|95.0|-0.62|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.62|0.016
73854057|NCT01942668|147255624|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|TWO_SIDED|95.0|-0.76|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.20|-0.76|<0.001
73854058|NCT01942668|147255624|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.141||0.023|TWO_SIDED|95.0|-0.6|-0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.05|-0.60|0.023
73854059|NCT01942668|147255625|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.84|-0.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.25|-0.84|<0.001
73854060|NCT01942668|147255625|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.146||0.004|TWO_SIDED|95.0|-0.71|-0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.13|-0.71|0.004
73854061|NCT01942668|147255625|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.149||0.003|TWO_SIDED|95.0|-0.73|-0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.14|-0.73|0.003
73854062|NCT01942668|147255625|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.147||0.179|TWO_SIDED|95.0|-0.49|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.09|-0.49|0.179
73854063|NCT01942668|147255626|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.169||0.012|TWO_SIDED|95.0|-0.76|-0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.76|0.012
73854064|NCT01942668|147255626|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.162|<|0.001|TWO_SIDED|95.0|-1.05|-0.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.41|-1.05|<0.001
73854065|NCT01942668|147255626|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.166||0.004|TWO_SIDED|95.0|-0.81|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.16|-0.81|0.004
73854066|NCT01942668|147255626|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.166||0.07|TWO_SIDED|95.0|-0.63|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.03|-0.63|0.070
73854067|NCT01942668|147255627|SUPERIORITY||Mean Difference (Final Values)|-4.39|STANDARD_ERROR_OF_MEAN|2.059||0.033|TWO_SIDED|95.0|-8.44|-0.35||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.35|-8.44|0.033
73854068|NCT01942668|147255627|SUPERIORITY||Mean Difference (Final Values)|-2.54|STANDARD_ERROR_OF_MEAN|2.015||0.207|TWO_SIDED|95.0|-6.5|1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.41|-6.50|0.207
73904233|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.394||||0.4909|TWO_SIDED|95.0|-2.937|6.049||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||6.049|-2.937|0.4909
73904234|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.383||||0.9151|TWO_SIDED|95.0|-7.549|6.783||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||6.783|-7.549|0.9151
73904235|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.394||||0.1533|TWO_SIDED|95.0|-2.069|12.857||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||12.857|-2.069|0.1533
73904236|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.506||||0.4371|TWO_SIDED|95.0|-3.904|8.915||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||8.915|-3.904|0.4371
73904237|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.6167|TWO_SIDED|95.0|-10.999|6.579||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||6.579|-10.999|0.6167
73904238|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.11||||0.1844|TWO_SIDED|95.0|-2.993|15.212||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||15.212|-2.993|0.1844
73904239|NCT01227564|147338828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95||||0.6205|TWO_SIDED|95.0|-5.888|9.878||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||9.878|-5.888|0.6205
73904240|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.418||||0.1695|TWO_SIDED|95.0|-0.183|1.018||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||1.018|-0.183|0.1695
73962531|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.1||0.0076|TWO_SIDED|95.0|-0.45|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.07|-0.45|0.0076
74084945|NCT00393705|147723537|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value for 2-Hours After Breakfast.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0027
74084946|NCT00393705|147723537|SUPERIORITY_OR_OTHER|||||||0.1947||95.0||||P-value for Pre-Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.1947
74084947|NCT00393705|147723537|SUPERIORITY_OR_OTHER|||||||0.0077||95.0||||P-value for 2-Hours After Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0077
74084948|NCT00393705|147723537|SUPERIORITY_OR_OTHER|||||||0.1885||95.0||||P-value for Pre-Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.1885
73904241|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147||||0.6331|TWO_SIDED|95.0|-0.465|0.759||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.759|-0.465|0.6331
73904242|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.2907|TWO_SIDED|95.0|-0.247|0.812||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.812|-0.247|0.2907
73904243|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007||||0.9846|TWO_SIDED|95.0|-0.675|0.688||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.688|-0.675|0.9846
73904244|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.304||||0.3845|TWO_SIDED|95.0|-1.0|0.392||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.392|-1.000|0.3845
73904245|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149||||0.6204|TWO_SIDED|95.0|-0.748|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.450|-0.748|0.6204
73904246|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014||||0.981|TWO_SIDED|95.0|-1.221|1.192||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||1.192|-1.221|0.9810
73904247|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.796||||0.2034|TWO_SIDED|95.0|-2.034|0.443||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.443|-2.034|0.2034
73962532|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.1||0.0003|TWO_SIDED|95.0|-0.54|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-0.54|0.0003
73962533|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.4402|TWO_SIDED|95.0|-0.27|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.27|0.4402
74084949|NCT00393705|147723537|SUPERIORITY_OR_OTHER|||||||0.5525||95.0||||P-value for 2-Hours After Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.5525
74084950|NCT00393705|147723537|SUPERIORITY_OR_OTHER|||||||0.4994||95.0||||P-value for 3:00 A.M.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.4994
74084951|NCT00393705|147723539|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||P-value for Total Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.7230
74084952|NCT00393705|147723539|SUPERIORITY_OR_OTHER|||||||0.0063||95.0||||P-value for Nocturnal Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0063
74024876|NCT01309737|147602230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.18||||0.0003|TWO_SIDED|95.0|1.77|10.25||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||10.25|1.77|0.0003
73904248|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.405||||0.4491|TWO_SIDED|95.0|-1.469|0.659||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.659|-1.469|0.4491
73904249|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.255||||0.8074|TWO_SIDED|95.0|-1.827|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||2.337|-1.827|0.8074
73904250|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.029||||0.3444|TWO_SIDED|95.0|-3.189|1.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||1.131|-3.189|0.3444
73904251|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387||||0.6772|TWO_SIDED|95.0|-2.239|1.464||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||1.464|-2.239|0.6772
73904252|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.652||||0.6325|TWO_SIDED|95.0|-2.063|3.367||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.367|-2.063|0.6325
73904253|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.5706|TWO_SIDED|95.0|-3.606|2.007||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.007|-3.606|0.5706
73904254|NCT01227564|147338829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.074||||0.9513|TWO_SIDED|95.0|-2.485|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.337|-2.485|0.9513
73904255|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.6054|TWO_SIDED|95.0|-0.074|0.043||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.043|-0.074|0.6054
74024877|NCT01309737|147602230|SUPERIORITY_OR_OTHER||Percent Difference|6.72|STANDARD_ERROR_OF_MEAN|2.26||0.0029|TWO_SIDED|95.0|2.3|11.14|||Normal Approximation|||||11.14|2.30|0.0029
74084953|NCT00393705|147723539|SUPERIORITY_OR_OTHER|||||||0.8876||95.0||||P-value for Severe Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.8876
74084954|NCT00393705|147723540|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0009
73962534|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.61|<0.0001
74084955|NCT00393705|147723541|SUPERIORITY_OR_OTHER|||||||0.0056||95.0||||P-value for Week 4|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0056
74084956|NCT00393705|147723541|SUPERIORITY_OR_OTHER|||||||0.0421||95.0||||P-value for Week 12|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0421
74084957|NCT00948792|147723546|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (30-minutes post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.8
73854069|NCT01942668|147255627|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|2.03||0.024|TWO_SIDED|95.0|-8.58|-0.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.61|-8.58|0.024
73854070|NCT01942668|147255627|SUPERIORITY||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|2.007||0.207|TWO_SIDED|95.0|-6.47|1.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.41|-6.47|0.207
73854071|NCT01942668|147255628|SUPERIORITY||Mean Difference (Final Values)|-5.48|STANDARD_ERROR_OF_MEAN|2.138||0.011|TWO_SIDED|95.0|-9.68|-1.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.28|-9.68|0.011
73854072|NCT01942668|147255628|SUPERIORITY||Mean Difference (Final Values)|-5.25|STANDARD_ERROR_OF_MEAN|2.093||0.012|TWO_SIDED|95.0|-9.36|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.14|-9.36|0.012
73854073|NCT01942668|147255628|SUPERIORITY||Mean Difference (Final Values)|-5.58|STANDARD_ERROR_OF_MEAN|2.122||0.009|TWO_SIDED|95.0|-9.75|-1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.41|-9.75|0.009
73854074|NCT01942668|147255628|SUPERIORITY||Mean Difference (Final Values)|-4.99|STANDARD_ERROR_OF_MEAN|2.096||0.018|TWO_SIDED|95.0|-9.11|-0.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.87|-9.11|0.018
73854075|NCT01942668|147255629|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|2.427||0.058|TWO_SIDED|95.0|-9.38|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.16|-9.38|0.058
73854076|NCT01942668|147255629|SUPERIORITY||Mean Difference (Final Values)|-7.48|STANDARD_ERROR_OF_MEAN|2.322||0.001|TWO_SIDED|95.0|-12.04|-2.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.92|-12.04|0.001
73854077|NCT01942668|147255629|SUPERIORITY||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|2.397|<|0.001|TWO_SIDED|95.0|-12.67|-3.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.25|-12.67|<0.001
73854078|NCT01942668|147255629|SUPERIORITY||Mean Difference (Final Values)|-6.78|STANDARD_ERROR_OF_MEAN|2.404||0.005|TWO_SIDED|95.0|-11.5|-2.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.06|-11.50|0.005
73854079|NCT01942668|147255630|SUPERIORITY||Mean Difference (Final Values)|-6.48|STANDARD_ERROR_OF_MEAN|2.77||0.02|TWO_SIDED|95.0|-11.92|-1.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.04|-11.92|0.020
73854080|NCT01942668|147255630|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|2.715||0.216|TWO_SIDED|95.0|-8.69|1.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.97|-8.69|0.216
73854081|NCT01942668|147255630|SUPERIORITY||Mean Difference (Final Values)|-5.85|STANDARD_ERROR_OF_MEAN|2.734||0.033|TWO_SIDED|95.0|-11.22|-0.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.48|-11.22|0.033
73854082|NCT01942668|147255630|SUPERIORITY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|2.685||0.265|TWO_SIDED|95.0|-8.27|2.28||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.28|-8.27|0.265
73854083|NCT01942668|147255631|SUPERIORITY||Mean Difference (Final Values)|-7.54|STANDARD_ERROR_OF_MEAN|2.854||0.008|TWO_SIDED|95.0|-13.14|-1.93||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.93|-13.14|0.008
73854084|NCT01942668|147255631|SUPERIORITY||Mean Difference (Final Values)|-6.72|STANDARD_ERROR_OF_MEAN|2.781||0.016|TWO_SIDED|95.0|-12.18|-1.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.26|-12.18|0.016
73854085|NCT01942668|147255631|SUPERIORITY||Mean Difference (Final Values)|-8.69|STANDARD_ERROR_OF_MEAN|2.847||0.002|TWO_SIDED|95.0|-14.28|-3.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.10|-14.28|0.002
73854086|NCT01942668|147255631|SUPERIORITY||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|2.8||0.028|TWO_SIDED|95.0|-11.68|-0.68||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.68|-11.68|0.028
73854087|NCT01942668|147255632|SUPERIORITY||Mean Difference (Final Values)|-6.56|STANDARD_ERROR_OF_MEAN|3.18||0.04|TWO_SIDED|95.0|-12.8|-0.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.31|-12.80|0.040
73962535|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.1543|TWO_SIDED|95.0|-0.38|0.06|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.38|0.1543
73854088|NCT01942668|147255632|SUPERIORITY||Mean Difference (Final Values)|-10.02|STANDARD_ERROR_OF_MEAN|3.04||0.001|TWO_SIDED|95.0|-15.99|-4.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.04|-15.99|0.001
73854089|NCT01942668|147255632|SUPERIORITY||Mean Difference (Final Values)|-9.96|STANDARD_ERROR_OF_MEAN|3.129||0.002|TWO_SIDED|95.0|-16.11|-3.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.81|-16.11|0.002
73854090|NCT01942668|147255632|SUPERIORITY||Mean Difference (Final Values)|-6.85|STANDARD_ERROR_OF_MEAN|3.127||0.029|TWO_SIDED|95.0|-12.99|-0.7||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.70|-12.99|0.029
73854091|NCT01942668|147255633|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|3.003||0.294|TWO_SIDED|95.0|-2.75|9.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.05|-2.75|0.294
73854092|NCT01942668|147255633|SUPERIORITY||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|2.922||0.327|TWO_SIDED|95.0|-2.87|8.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||8.60|-2.87|0.327
73854093|NCT01942668|147255633|SUPERIORITY||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|2.947||0.637|TWO_SIDED|95.0|-7.18|4.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.39|-7.18|0.637
73854094|NCT01942668|147255633|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|2.893||0.952|TWO_SIDED|95.0|-5.51|5.86||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||5.86|-5.51|0.952
73854095|NCT01942668|147255634|SUPERIORITY||Mean Difference (Final Values)|1.82|STANDARD_ERROR_OF_MEAN|3.219||0.573|TWO_SIDED|95.0|-4.51|8.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||8.14|-4.51|0.573
73854096|NCT01942668|147255634|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|3.107||0.769|TWO_SIDED|95.0|-7.01|5.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||5.19|-7.01|0.769
73854097|NCT01942668|147255634|SUPERIORITY||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|3.176||0.047|TWO_SIDED|95.0|-12.56|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.09|-12.56|0.047
73854098|NCT01942668|147255634|SUPERIORITY||Mean Difference (Final Values)|-2.59|STANDARD_ERROR_OF_MEAN|3.133||0.409|TWO_SIDED|95.0|-8.74|3.56||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.56|-8.74|0.409
73854099|NCT01942668|147255635|SUPERIORITY||Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|3.443||0.579|TWO_SIDED|95.0|-4.85|8.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||8.67|-4.85|0.579
73854100|NCT01942668|147255635|SUPERIORITY||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|3.275||0.223|TWO_SIDED|95.0|-10.43|2.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.44|-10.43|0.223
73854101|NCT01942668|147255635|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|3.367||0.542|TWO_SIDED|95.0|-8.67|4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||4.56|-8.67|0.542
73854102|NCT01942668|147255635|SUPERIORITY||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|3.376||0.476|TWO_SIDED|95.0|-9.04|4.23||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||4.23|-9.04|0.476
73854103|NCT01942668|147255636|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|2.593||0.631|TWO_SIDED|95.0|-6.34|3.84||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.84|-6.34|0.631
73854104|NCT01942668|147255636|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|2.54||0.651|TWO_SIDED|95.0|-3.84|6.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||6.14|-3.84|0.651
73854105|NCT01942668|147255636|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|2.578||0.813|TWO_SIDED|95.0|-5.67|4.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.45|-5.67|0.813
73854106|NCT01942668|147255636|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.515||0.869|TWO_SIDED|95.0|-5.35|4.52||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.52|-5.35|0.869
73854107|NCT01942668|147255637|SUPERIORITY||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|2.79||0.074|TWO_SIDED|95.0|-10.48|0.48||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.48|-10.48|0.074
73854108|NCT01942668|147255637|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|2.722||0.748|TWO_SIDED|95.0|-6.22|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||4.47|-6.22|0.748
74084958|NCT00948792|147723547|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (6-hour post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.26
73854109|NCT01942668|147255637|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|2.805||0.987|TWO_SIDED|95.0|-5.46|5.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||5.56|-5.46|0.987
73854110|NCT01942668|147255637|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|2.741||0.709|TWO_SIDED|95.0|-6.41|4.36||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||4.36|-6.41|0.709
73854111|NCT01942668|147255638|SUPERIORITY||Mean Difference (Final Values)|-2.61|STANDARD_ERROR_OF_MEAN|2.968||0.379|TWO_SIDED|95.0|-8.44|3.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||3.22|-8.44|0.379
73854112|NCT01942668|147255638|SUPERIORITY||Mean Difference (Final Values)|-3.07|STANDARD_ERROR_OF_MEAN|2.832||0.279|TWO_SIDED|95.0|-8.64|2.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.49|-8.64|0.279
73854113|NCT01942668|147255638|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|2.949||0.894|TWO_SIDED|95.0|-6.19|5.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.40|-6.19|0.894
73854114|NCT01942668|147255638|SUPERIORITY||Mean Difference (Final Values)|-2.98|STANDARD_ERROR_OF_MEAN|2.923||0.308|TWO_SIDED|95.0|-8.72|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.76|-8.72|0.308
73854115|NCT01942668|147255639|SUPERIORITY||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|3.081||0.558|TWO_SIDED|95.0|-4.24|7.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.86|-4.24|0.558
73854116|NCT01942668|147255639|SUPERIORITY||Mean Difference (Final Values)|3.61|STANDARD_ERROR_OF_MEAN|3.031||0.233|TWO_SIDED|95.0|-2.34|9.57||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.57|-2.34|0.233
73854117|NCT01942668|147255639|SUPERIORITY||Mean Difference (Final Values)|6.16|STANDARD_ERROR_OF_MEAN|3.036||0.043|TWO_SIDED|95.0|0.2|12.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||12.13|0.20|0.043
73854118|NCT01942668|147255639|SUPERIORITY||Mean Difference (Final Values)|2.07|STANDARD_ERROR_OF_MEAN|2.99||0.488|TWO_SIDED|95.0|-3.8|7.95||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||7.95|-3.80|0.488
73854119|NCT01942668|147255640|SUPERIORITY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|3.206||0.205|TWO_SIDED|95.0|-2.23|10.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||10.37|-2.23|0.205
73854120|NCT01942668|147255640|SUPERIORITY||Mean Difference (Final Values)|9.58|STANDARD_ERROR_OF_MEAN|3.133||0.002|TWO_SIDED|95.0|3.43|15.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||15.74|3.43|0.002
73854121|NCT01942668|147255640|SUPERIORITY||Mean Difference (Final Values)|5.04|STANDARD_ERROR_OF_MEAN|3.193||0.115|TWO_SIDED|95.0|-1.23|11.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||11.32|-1.23|0.115
73854122|NCT01942668|147255640|SUPERIORITY||Mean Difference (Final Values)|8.94|STANDARD_ERROR_OF_MEAN|3.152||0.005|TWO_SIDED|95.0|2.75|15.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||15.13|2.75|0.005
73854123|NCT01942668|147255641|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|3.719||0.796|TWO_SIDED|95.0|-6.34|8.27||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||8.27|-6.34|0.796
73854124|NCT01942668|147255641|SUPERIORITY||Mean Difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|3.568||0.15|TWO_SIDED|95.0|-1.87|12.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||12.15|-1.87|0.150
73854125|NCT01942668|147255641|SUPERIORITY||Mean Difference (Final Values)|8.58|STANDARD_ERROR_OF_MEAN|3.657||0.019|TWO_SIDED|95.0|1.39|15.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||15.77|1.39|0.019
73854126|NCT01942668|147255641|SUPERIORITY||Mean Difference (Final Values)|7.51|STANDARD_ERROR_OF_MEAN|3.667||0.041|TWO_SIDED|95.0|0.3|14.71||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||14.71|0.30|0.041
73854127|NCT01942668|147255642|SUPERIORITY||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|2.197||0.221|TWO_SIDED|95.0|-7.0|1.62||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.62|-7.00|0.221
73854128|NCT01942668|147255642|SUPERIORITY||Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|2.154||0.511|TWO_SIDED|95.0|-5.65|2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||2.81|-5.65|0.511
73854129|NCT01942668|147255642|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|2.168||0.761|TWO_SIDED|95.0|-3.6|4.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.92|-3.60|0.761
73854130|NCT01942668|147255642|SUPERIORITY||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|2.128||0.332|TWO_SIDED|95.0|-6.25|2.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.11|-6.25|0.332
73854131|NCT01942668|147255643|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.474||0.687|TWO_SIDED|95.0|-5.86|3.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||3.86|-5.86|0.687
73854132|NCT01942668|147255643|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|2.411||0.373|TWO_SIDED|95.0|-6.88|2.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.58|-6.88|0.373
73854133|NCT01942668|147255643|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|2.466||0.714|TWO_SIDED|95.0|-5.75|3.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.94|-5.75|0.714
73854134|NCT01942668|147255643|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.427||0.711|TWO_SIDED|95.0|-5.67|3.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.87|-5.67|0.711
73854135|NCT01942668|147255644|SUPERIORITY||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|2.682||0.415|TWO_SIDED|95.0|-7.46|3.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||3.08|-7.46|0.415
73854136|NCT01942668|147255644|SUPERIORITY||Mean Difference (Final Values)|-6.01|STANDARD_ERROR_OF_MEAN|2.564||0.019|TWO_SIDED|95.0|-11.04|-0.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.97|-11.04|0.019
73854137|NCT01942668|147255644|SUPERIORITY||Mean Difference (Final Values)|-4.72|STANDARD_ERROR_OF_MEAN|2.639||0.074|TWO_SIDED|95.0|-9.9|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.46|-9.90|0.074
73854138|NCT01942668|147255644|SUPERIORITY||Mean Difference (Final Values)|-5.75|STANDARD_ERROR_OF_MEAN|2.637||0.03|TWO_SIDED|95.0|-10.94|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.57|-10.94|0.030
73854139|NCT01942668|147255645|SUPERIORITY||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.109||0.059|TWO_SIDED|95.0|-8.13|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-8.13|0.059
73904256|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.4087|TWO_SIDED|95.0|-0.035|0.084||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.084|-0.035|0.4087
73904257|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.8518|TWO_SIDED|95.0|-0.046|0.056||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.056|-0.046|0.8518
73854140|NCT01942668|147255645|SUPERIORITY||Mean Difference (Final Values)|-2.57|STANDARD_ERROR_OF_MEAN|2.067||0.215|TWO_SIDED|95.0|-6.63|1.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.49|-6.63|0.215
73854141|NCT01942668|147255645|SUPERIORITY||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|2.084||0.015|TWO_SIDED|95.0|-9.19|-1.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.00|-9.19|0.015
73854142|NCT01942668|147255645|SUPERIORITY||Mean Difference (Final Values)|-3.16|STANDARD_ERROR_OF_MEAN|2.042||0.122|TWO_SIDED|95.0|-7.17|0.85||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.85|-7.17|0.122
74088294|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|0.74||||0.0787|TWO_SIDED|95.0|0.53|1.04|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.04|0.53|0.0787
73854143|NCT01942668|147255646|SUPERIORITY||Mean Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|2.135||0.013|TWO_SIDED|95.0|-9.52|-1.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.13|-9.52|0.013
73854144|NCT01942668|147255646|SUPERIORITY||Mean Difference (Final Values)|-5.76|STANDARD_ERROR_OF_MEAN|2.08||0.006|TWO_SIDED|95.0|-9.85|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.68|-9.85|0.006
73854145|NCT01942668|147255646|SUPERIORITY||Mean Difference (Final Values)|-5.59|STANDARD_ERROR_OF_MEAN|2.132||0.009|TWO_SIDED|95.0|-9.77|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.40|-9.77|0.009
73854146|NCT01942668|147255646|SUPERIORITY||Mean Difference (Final Values)|-5.68|STANDARD_ERROR_OF_MEAN|2.093||0.007|TWO_SIDED|95.0|-9.79|-1.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.57|-9.79|0.007
73854147|NCT01942668|147255647|SUPERIORITY||Mean Difference (Final Values)|-3.39|STANDARD_ERROR_OF_MEAN|2.47||0.171|TWO_SIDED|95.0|-8.24|1.47||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||1.47|-8.24|0.171
74024878|NCT01309737|147602231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.06|||<|0.0001|TWO_SIDED|95.0|5.02|16.45||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||16.45|5.02|<0.0001
74084959|NCT00948792|147723548|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in the change in post-transfusion platelet counts (30 minutes and 6 hours post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.09
73854148|NCT01942668|147255647|SUPERIORITY||Mean Difference (Final Values)|-6.49|STANDARD_ERROR_OF_MEAN|2.364||0.006|TWO_SIDED|95.0|-11.14|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.85|-11.14|0.006
73854149|NCT01942668|147255647|SUPERIORITY||Mean Difference (Final Values)|-7.39|STANDARD_ERROR_OF_MEAN|2.434||0.003|TWO_SIDED|95.0|-12.17|-2.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.61|-12.17|0.003
73854150|NCT01942668|147255647|SUPERIORITY||Mean Difference (Final Values)|-6.69|STANDARD_ERROR_OF_MEAN|2.429||0.006|TWO_SIDED|95.0|-11.46|-1.92||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.92|-11.46|0.006
74088295|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0129|TWO_SIDED|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.47|0.0129
73854151|NCT01942668|147255648|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|2.037||0.039|TWO_SIDED|95.0|-8.21|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.21|-8.21|0.039
73854152|NCT01942668|147255648|SUPERIORITY||Mean Difference (Final Values)|-2.39|STANDARD_ERROR_OF_MEAN|1.997||0.232|TWO_SIDED|95.0|-6.31|1.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.53|-6.31|0.232
73854153|NCT01942668|147255648|SUPERIORITY||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|2.012||0.03|TWO_SIDED|95.0|-8.32|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.42|-8.32|0.030
73904258|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.4216|TWO_SIDED|95.0|-0.085|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.036|-0.085|0.4216
73904259|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.273|TWO_SIDED|95.0|-0.028|0.097||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.097|-0.028|0.2730
73904260|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.8549|TWO_SIDED|95.0|-0.048|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.058|-0.048|0.8549
73854154|NCT01942668|147255648|SUPERIORITY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|1.973||0.262|TWO_SIDED|95.0|-6.09|1.66||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.66|-6.09|0.262
73854155|NCT01942668|147255649|SUPERIORITY||Mean Difference (Final Values)|-5.41|STANDARD_ERROR_OF_MEAN|2.119||0.011|TWO_SIDED|95.0|-9.57|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.25|-9.57|0.011
73854156|NCT01942668|147255649|SUPERIORITY||Mean Difference (Final Values)|-5.54|STANDARD_ERROR_OF_MEAN|2.065||0.008|TWO_SIDED|95.0|-9.6|-1.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.48|-9.60|0.008
73854157|NCT01942668|147255649|SUPERIORITY||Mean Difference (Final Values)|-5.74|STANDARD_ERROR_OF_MEAN|2.115||0.007|TWO_SIDED|95.0|-9.9|-1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.59|-9.90|0.007
73854158|NCT01942668|147255649|SUPERIORITY||Mean Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|2.078||0.011|TWO_SIDED|95.0|-9.4|-1.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.24|-9.40|0.011
73904261|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.5847|TWO_SIDED|95.0|-0.12|0.068||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.068|-0.120|0.5847
74088296|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0124|TWO_SIDED|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.47|0.0124
73904262|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067||||0.174|TWO_SIDED|95.0|-0.03|0.163||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.163|-0.030|0.1740
73904263|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.6255|TWO_SIDED|95.0|-0.063|0.103||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.103|-0.063|0.6255
73904264|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023||||0.7658|TWO_SIDED|95.0|-0.177|0.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.131|-0.177|0.7658
73904265|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.3309|TWO_SIDED|95.0|-0.082|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.240|-0.082|0.3309
73904266|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.6872|TWO_SIDED|95.0|-0.11|0.166||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.166|-0.110|0.6872
73854159|NCT01942668|147255650|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|2.421||0.083|TWO_SIDED|95.0|-8.96|0.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.55|-8.96|0.083
73854160|NCT01942668|147255650|SUPERIORITY||Mean Difference (Final Values)|-7.36|STANDARD_ERROR_OF_MEAN|2.317||0.002|TWO_SIDED|95.0|-11.91|-2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.81|-11.91|0.002
73854161|NCT01942668|147255650|SUPERIORITY||Mean Difference (Final Values)|-7.92|STANDARD_ERROR_OF_MEAN|2.384|<|0.001|TWO_SIDED|95.0|-12.6|-3.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.23|-12.60|<0.001
73854162|NCT01942668|147255650|SUPERIORITY||Mean Difference (Final Values)|-6.78|STANDARD_ERROR_OF_MEAN|2.381||0.005|TWO_SIDED|95.0|-11.46|-2.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.10|-11.46|0.005
73971056|NCT02969707|147482294|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable.||||||0.022|||||||Regression, Linear|(R² = .103, F(1,49) = 5.632, β = .321, p = .022)||In people with FMS, the linear relationship between Thermal Pain Tolerance and E/I ratio as it relates to creatine was assessed.||||0.022
73854163|NCT01942668|147255651|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.938|TWO_SIDED|95.0|-0.12|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.12|0.938
73854164|NCT01942668|147255651|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.059||0.779|TWO_SIDED|95.0|-0.1|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.13|-0.10|0.779
73904267|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.9752|TWO_SIDED|95.0|-0.196|0.202||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.202|-0.196|0.9752
73904268|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143||||0.1715|TWO_SIDED|95.0|-0.064|0.349||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.349|-0.064|0.1715
73904269|NCT01227564|147338830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.4145|TWO_SIDED|95.0|-0.105|0.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.250|-0.105|0.4145
73904270|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011||||0.5134|TWO_SIDED|95.0|-0.043|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.022|-0.043|0.5134
73904271|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.6083|TWO_SIDED|95.0|-0.024|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.041|-0.024|0.6083
73904272|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001||||0.9401|TWO_SIDED|95.0|-0.029|0.027||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.027|-0.029|0.9401
73904273|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018||||0.295|TWO_SIDED|95.0|-0.051|0.016||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.016|-0.051|0.2950
73962536|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.11||0.0053|TWO_SIDED|95.0|-0.53|-0.09|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.09|-0.53|0.0053
73962537|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6445|TWO_SIDED|95.0|-0.33|0.2|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.33|0.6445
73962538|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1439|TWO_SIDED|95.0|-0.47|0.07|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.07|-0.47|0.1439
73962539|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8402|TWO_SIDED|95.0|-0.3|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.30|0.8402
74084960|NCT01923311|147723572|EQUIVALENCE|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG AUCtau in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG AUCtau is 0.36 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|135.73|||||TWO_SIDED|90.0|116.24|158.49||||||To determine whether the proposed EVG dose in children achieved similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).||158.49|116.24|
73854165|NCT01942668|147255651|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.059||0.646|TWO_SIDED|95.0|-0.14|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.14|0.646
73854166|NCT01942668|147255651|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.058||0.421|TWO_SIDED|95.0|-0.07|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.07|0.421
73854167|NCT01942668|147255652|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.063||0.075|TWO_SIDED|95.0|-0.01|0.24||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.01|0.075
73854168|NCT01942668|147255652|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.062||0.074|TWO_SIDED|95.0|-0.01|0.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.23|-0.01|0.074
73854169|NCT01942668|147255652|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.063||0.37|TWO_SIDED|95.0|-0.07|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.07|0.370
73854170|NCT01942668|147255652|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.062||0.851|TWO_SIDED|95.0|-0.11|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.13|-0.11|0.851
73854171|NCT01942668|147255653|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.067||0.452|TWO_SIDED|95.0|-0.18|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.18|0.452
73854172|NCT01942668|147255653|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.064||0.244|TWO_SIDED|95.0|-0.05|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.20|-0.05|0.244
73854173|NCT01942668|147255653|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.065||0.354|TWO_SIDED|95.0|-0.19|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.07|-0.19|0.354
73854174|NCT01942668|147255653|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.065||0.527|TWO_SIDED|95.0|-0.17|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.09|-0.17|0.527
73904274|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.8817|TWO_SIDED|95.0|-0.031|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.037|-0.031|0.8817
73962540|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4439|TWO_SIDED|95.0|-0.38|0.17|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.38|0.4439
73962541|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.9376|TWO_SIDED|95.0|-0.27|0.29|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.27|0.9376
73854175|NCT01942668|147255654|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-2.29|-1.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.55|-2.29|<0.001
73854176|NCT01942668|147255654|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.07|-1.81|<0.001
73854177|NCT01942668|147255654|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.07|-1.81|<0.001
73962542|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7614|TWO_SIDED|95.0|-0.33|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.33|0.7614
73854178|NCT01942668|147255654|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.188|<|0.001|TWO_SIDED|95.0|-1.62|-0.88||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.88|-1.62|<0.001
73854179|NCT01942668|147255655|SUPERIORITY||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.199|<|0.001|TWO_SIDED|95.0|-2.12|-1.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.34|-2.12|<0.001
73854180|NCT01942668|147255655|SUPERIORITY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.197|<|0.001|TWO_SIDED|95.0|-1.68|-0.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.91|-1.68|<0.001
73854181|NCT01942668|147255655|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.197|<|0.001|TWO_SIDED|95.0|-1.58|-0.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.81|-1.58|<0.001
73854182|NCT01942668|147255655|SUPERIORITY||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.198|<|0.001|TWO_SIDED|95.0|-1.34|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.57|-1.34|<0.001
73854183|NCT01942668|147255656|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.207|<|0.001|TWO_SIDED|95.0|-2.06|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.25|-2.06|<0.001
73854184|NCT01942668|147255656|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.204|<|0.001|TWO_SIDED|95.0|-1.87|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.07|-1.87|<0.001
73854185|NCT01942668|147255656|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.205|<|0.001|TWO_SIDED|95.0|-1.7|-0.9||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.90|-1.70|<0.001
73854186|NCT01942668|147255656|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.207|<|0.001|TWO_SIDED|95.0|-1.48|-0.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.67|-1.48|<0.001
73854187|NCT01942668|147255657|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.131||0.126|TWO_SIDED|95.0|-0.46|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.46|0.126
73854188|NCT01942668|147255657|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.2|TWO_SIDED|95.0|-0.42|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.42|0.200
73854189|NCT01942668|147255657|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.13||0.222|TWO_SIDED|95.0|-0.41|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.10|-0.41|0.222
73854190|NCT01942668|147255657|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.358|TWO_SIDED|95.0|-0.37|0.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.37|0.358
73854191|NCT01942668|147255658|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.138||0.023|TWO_SIDED|95.0|-0.59|-0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.04|-0.59|0.023
73854192|NCT01942668|147255658|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.138||0.045|TWO_SIDED|95.0|-0.55|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.01|-0.55|0.045
73854193|NCT01942668|147255658|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.137||0.384|TWO_SIDED|95.0|-0.39|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.15|-0.39|0.384
73854194|NCT01942668|147255658|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.138||0.424|TWO_SIDED|95.0|-0.38|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.16|-0.38|0.424
73854195|NCT01942668|147255659|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.152||0.153|TWO_SIDED|95.0|-0.52|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.52|0.153
73962543|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.8081|TWO_SIDED|95.0|-0.32|0.25|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.32|0.8081
73854196|NCT01942668|147255659|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.151||0.058|TWO_SIDED|95.0|-0.58|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.01|-0.58|0.058
73854197|NCT01942668|147255659|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.151||0.55|TWO_SIDED|95.0|-0.39|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.21|-0.39|0.550
73854198|NCT01942668|147255659|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.153||0.854|TWO_SIDED|95.0|-0.33|0.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.27|-0.33|0.854
73854199|NCT01942668|147255660|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.116||0.181|TWO_SIDED|95.0|-0.38|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.07|-0.38|0.181
73854200|NCT01942668|147255660|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.116||0.108|TWO_SIDED|95.0|-0.41|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.04|-0.41|0.108
73854201|NCT01942668|147255660|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.115||0.014|TWO_SIDED|95.0|-0.51|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.51|0.014
73854202|NCT01942668|147255660|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.115||0.323|TWO_SIDED|95.0|-0.34|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.34|0.323
73854203|NCT01942668|147255661|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.124||0.056|TWO_SIDED|95.0|-0.48|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.01|-0.48|0.056
73854204|NCT01942668|147255661|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.124||0.279|TWO_SIDED|95.0|-0.38|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.11|-0.38|0.279
73854205|NCT01942668|147255661|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.123||0.435|TWO_SIDED|95.0|-0.34|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.15|-0.34|0.435
73854206|NCT01942668|147255661|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.124||0.607|TWO_SIDED|95.0|-0.31|0.18||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.31|0.607
73854207|NCT01942668|147255662|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.138||0.06|TWO_SIDED|95.0|-0.53|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.01|-0.53|0.060
73854208|NCT01942668|147255662|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.137||0.026|TWO_SIDED|95.0|-0.57|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.04|-0.57|0.026
73854209|NCT01942668|147255662|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.136||0.097|TWO_SIDED|95.0|-0.49|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.04|-0.49|0.097
73854210|NCT01942668|147255662|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.138||0.23|TWO_SIDED|95.0|-0.44|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.10|-0.44|0.230
73854211|NCT01942668|147255663|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.107|TWO_SIDED|95.0|-0.61|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.61|0.107
73854212|NCT01942668|147255663|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.169||0.302|TWO_SIDED|95.0|-0.51|0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.51|0.302
73854213|NCT01942668|147255663|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.169||0.106|TWO_SIDED|95.0|-0.6|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.60|0.106
73854214|NCT01942668|147255663|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.169||0.156|TWO_SIDED|95.0|-0.57|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.57|0.156
73854215|NCT01942668|147255664|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.177||0.081|TWO_SIDED|95.0|-0.65|0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.04|-0.65|0.081
73854216|NCT01942668|147255664|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.175||0.212|TWO_SIDED|95.0|-0.56|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.12|-0.56|0.212
73854217|NCT01942668|147255664|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.175||0.345|TWO_SIDED|95.0|-0.51|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.51|0.345
73854218|NCT01942668|147255664|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.176||0.829|TWO_SIDED|95.0|-0.38|0.31||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.31|-0.38|0.829
73904275|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.6072|TWO_SIDED|95.0|-0.037|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.022|-0.037|0.6072
73854219|NCT01942668|147255665|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.201||0.029|TWO_SIDED|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.05|-0.84|0.029
73854220|NCT01942668|147255665|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.199||0.026|TWO_SIDED|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.05|-0.84|0.026
74024879|NCT01309737|147602231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.97|||<|0.0001||95.0|9.0|30.73||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||30.73|9.00|<0.0001
73854221|NCT01942668|147255665|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.199||0.093|TWO_SIDED|95.0|-0.72|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.06|-0.72|0.093
73854222|NCT01942668|147255665|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.202||0.223|TWO_SIDED|95.0|-0.64|0.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.64|0.223
73854223|NCT01942668|147255666|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.85|-0.4||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.40|-0.85|<0.001
73854224|NCT01942668|147255666|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.71|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.26|-0.71|<0.001
73854225|NCT01942668|147255666|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.75|-0.3||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.30|-0.75|<0.001
73854226|NCT01942668|147255666|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.64|-0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.20|-0.64|<0.001
73854227|NCT01942668|147255667|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.85|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.38|-0.85|<0.001
73854228|NCT01942668|147255667|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.69|-0.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.22|-0.69|<0.001
73854229|NCT01942668|147255667|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.003|TWO_SIDED|95.0|-0.59|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.12|-0.59|0.003
73854230|NCT01942668|147255667|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.03|TWO_SIDED|95.0|-0.5|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.03|-0.50|0.030
73854231|NCT01942668|147255668|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.89|-0.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.36|-0.89|<0.001
73854232|NCT01942668|147255668|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.88|-0.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.36|-0.88|<0.001
73854233|NCT01942668|147255668|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.73|-0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.21|-0.73|<0.001
73854234|NCT01942668|147255668|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.006|TWO_SIDED|95.0|-0.63|-0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.63|0.006
73854235|NCT01942668|147255669|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|1.629||0.003|TWO_SIDED|95.0|-8.08|-1.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.69|-8.08|0.003
73854236|NCT01942668|147255669|SUPERIORITY||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|1.626||0.027|TWO_SIDED|95.0|-6.8|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.42|-6.80|0.027
73854237|NCT01942668|147255669|SUPERIORITY||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|1.618||0.034|TWO_SIDED|95.0|-6.61|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.26|-6.61|0.034
73904276|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.6259|TWO_SIDED|95.0|-0.06|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.036|-0.060|0.6259
73930724|NCT03238911|147391298|SUPERIORITY||Mean Difference (Final Values)|-78.6||||0.001|TWO_SIDED|95.0|-124.81|-32.39|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-32.39|-124.81|0.0010
73904277|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.2807|TWO_SIDED|95.0|-0.023|0.076||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.076|-0.023|0.2807
73904278|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.008||||0.7224|TWO_SIDED|95.0|-0.035|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.050|-0.035|0.7224
73904279|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.8532|TWO_SIDED|95.0|-0.08|0.067||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.067|-0.080|0.8532
73904280|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.3116|TWO_SIDED|95.0|-0.038|0.116||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.116|-0.038|0.3116
73904281|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.6246|TWO_SIDED|95.0|-0.049|0.082||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.082|-0.049|0.6246
73904282|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.8697|TWO_SIDED|95.0|-0.092|0.108||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.108|-0.092|0.8697
73904283|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072||||0.1707|TWO_SIDED|95.0|-0.032|0.176||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.176|-0.032|0.1707
73904284|NCT01227564|147338831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.3732|TWO_SIDED|95.0|-0.049|0.129||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.129|-0.049|0.3732
73962544|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.8078|TWO_SIDED|95.0|-0.25|0.33|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.33|-0.25|0.8078
73962545|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.15||0.9705|TWO_SIDED|95.0|-0.28|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.28|0.9705
74024880|NCT01309737|147602231|SUPERIORITY_OR_OTHER||Percent difference|13.62||||0.0002|TWO_SIDED|95.0|6.54|20.69|||Normal Approximation|||||20.69|6.54|0.0002
73904285|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.7259|TWO_SIDED|95.0|-0.04|0.028||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.028|-0.040|0.7259
73904286|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.3517|TWO_SIDED|95.0|-0.018|0.051||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.051|-0.018|0.3517
73904287|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.7311|TWO_SIDED|95.0|-0.024|0.035||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.035|-0.024|0.7311
73904288|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.6446|TWO_SIDED|95.0|-0.041|0.026||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.026|-0.041|0.6446
73904289|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.064|TWO_SIDED|95.0|-0.002|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.066|-0.002|0.0640
73904290|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012||||0.4057|TWO_SIDED|95.0|-0.017|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.041|-0.017|0.4057
73904291|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.5742|TWO_SIDED|95.0|-0.066|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.037|-0.066|0.5742
73904292|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1336|TWO_SIDED|95.0|-0.013|0.093||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.093|-0.013|0.1336
73904293|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.013||||0.5734|TWO_SIDED|95.0|-0.033|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.058|-0.033|0.5734
74088297|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|0.7||||0.0399|TWO_SIDED|95.0|0.5|0.98|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.98|0.50|0.0399
73854238|NCT01942668|147255669|SUPERIORITY||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|1.621||0.119|TWO_SIDED|95.0|-5.71|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.65|-5.71|0.119
73854239|NCT01942668|147255670|SUPERIORITY||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|1.7||0.002|TWO_SIDED|95.0|-8.73|-2.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.05|-8.73|0.002
73854240|NCT01942668|147255670|SUPERIORITY||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|1.696||0.002|TWO_SIDED|95.0|-8.72|-2.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.06|-8.72|0.002
73854241|NCT01942668|147255670|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|1.685||0.004|TWO_SIDED|95.0|-8.19|-1.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.58|-8.19|0.004
73854242|NCT01942668|147255670|SUPERIORITY||Mean Difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|1.698||0.009|TWO_SIDED|95.0|-7.75|-1.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.09|-7.75|0.009
73854243|NCT01942668|147255671|SUPERIORITY||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|1.855|<|0.001|TWO_SIDED|95.0|-10.18|-2.9||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.90|-10.18|<0.001
73854244|NCT01942668|147255671|SUPERIORITY||Mean Difference (Final Values)|-7.61|STANDARD_ERROR_OF_MEAN|1.843|<|0.001|TWO_SIDED|95.0|-11.23|-4.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.00|-11.23|<0.001
73854245|NCT01942668|147255671|SUPERIORITY||Mean Difference (Final Values)|-7.44|STANDARD_ERROR_OF_MEAN|1.835|<|0.001|TWO_SIDED|95.0|-11.04|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.84|-11.04|<0.001
73854246|NCT01942668|147255671|SUPERIORITY||Mean Difference (Final Values)|-6.76|STANDARD_ERROR_OF_MEAN|1.863|<|0.001|TWO_SIDED|95.0|-10.41|-3.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.10|-10.41|<0.001
73854247|NCT01942668|147255672|SUPERIORITY||Mean Difference (Final Values)|-7.34|STANDARD_ERROR_OF_MEAN|2.146|<|0.001|TWO_SIDED|95.0|-11.55|-3.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-3.13|-11.55|<0.001
73854248|NCT01942668|147255672|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.139||0.009|TWO_SIDED|95.0|-9.8|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.40|-9.80|0.009
73854249|NCT01942668|147255672|SUPERIORITY||Mean Difference (Final Values)|-5.13|STANDARD_ERROR_OF_MEAN|2.132||0.016|TWO_SIDED|95.0|-9.31|-0.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.95|-9.31|0.016
73854250|NCT01942668|147255672|SUPERIORITY||Mean Difference (Final Values)|-3.04|STANDARD_ERROR_OF_MEAN|2.13||0.154|TWO_SIDED|95.0|-7.22|1.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.14|-7.22|0.154
73854251|NCT01942668|147255673|SUPERIORITY||Mean Difference (Final Values)|-8.38|STANDARD_ERROR_OF_MEAN|2.213|<|0.001|TWO_SIDED|95.0|-12.72|-4.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-4.04|-12.72|<0.001
73904294|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.016||||0.7067|TWO_SIDED|95.0|-0.104|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.071|-0.104|0.7067
73904295|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.36|TWO_SIDED|95.0|-0.049|0.132||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.132|-0.049|0.3600
73904296|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013||||0.7454|TWO_SIDED|95.0|-0.065|0.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.090|-0.065|0.7454
73854252|NCT01942668|147255673|SUPERIORITY||Mean Difference (Final Values)|-7.52|STANDARD_ERROR_OF_MEAN|2.201|<|0.001|TWO_SIDED|95.0|-11.83|-3.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.20|-11.83|<0.001
73854253|NCT01942668|147255673|SUPERIORITY||Mean Difference (Final Values)|-7.32|STANDARD_ERROR_OF_MEAN|2.193|<|0.001|TWO_SIDED|95.0|-11.63|-3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.02|-11.63|<0.001
73930725|NCT03238911|147391298|SUPERIORITY||Mean Difference (Final Values)|-58.79||||0.0002|TWO_SIDED|95.0|-88.75|-28.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-28.82|-88.75|0.0002
73854254|NCT01942668|147255673|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.207||0.011|TWO_SIDED|95.0|-9.93|-1.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.27|-9.93|0.011
73854255|NCT01942668|147255674|SUPERIORITY||Mean Difference (Final Values)|-8.97|STANDARD_ERROR_OF_MEAN|2.439|<|0.001|TWO_SIDED|95.0|-13.76|-4.19||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.19|-13.76|<0.001
73854256|NCT01942668|147255674|SUPERIORITY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-14.34|-4.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.85|-14.34|<0.001
73854257|NCT01942668|147255674|SUPERIORITY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|2.412|<|0.001|TWO_SIDED|95.0|-14.03|-4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.56|-14.03|<0.001
73854258|NCT01942668|147255674|SUPERIORITY||Mean Difference (Final Values)|-7.72|STANDARD_ERROR_OF_MEAN|2.442||0.002|TWO_SIDED|95.0|-12.51|-2.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.93|-12.51|0.002
73854259|NCT01942668|147255675|SUPERIORITY||Mean Difference (Final Values)|2.02|STANDARD_ERROR_OF_MEAN|2.576||0.434|TWO_SIDED|95.0|-3.03|7.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.07|-3.03|0.434
73854260|NCT01942668|147255675|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|2.564||0.442|TWO_SIDED|95.0|-3.06|7.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.00|-3.06|0.442
73854261|NCT01942668|147255675|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|2.558||0.558|TWO_SIDED|95.0|-3.52|6.51||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||6.51|-3.52|0.558
73854262|NCT01942668|147255675|SUPERIORITY||Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|2.555||0.534|TWO_SIDED|95.0|-3.42|6.6||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||6.60|-3.42|0.534
73854263|NCT01942668|147255676|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|2.719||0.927|TWO_SIDED|95.0|-5.08|5.58||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||5.58|-5.08|0.927
73854264|NCT01942668|147255676|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|2.699||0.541|TWO_SIDED|95.0|-6.95|3.64||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||3.64|-6.95|0.541
73854265|NCT01942668|147255676|SUPERIORITY||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|2.691||0.171|TWO_SIDED|95.0|-8.96|1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||1.60|-8.96|0.171
73854266|NCT01942668|147255676|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|2.708||0.667|TWO_SIDED|95.0|-6.48|4.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||4.15|-6.48|0.667
73854267|NCT01942668|147255677|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.863||0.662|TWO_SIDED|95.0|-4.36|6.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||6.87|-4.36|0.662
73854268|NCT01942668|147255677|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|2.834||0.635|TWO_SIDED|95.0|-6.91|4.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||4.21|-6.91|0.635
73854269|NCT01942668|147255677|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.827||0.877|TWO_SIDED|95.0|-5.98|5.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.11|-5.98|0.877
73854270|NCT01942668|147255677|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|2.867||0.893|TWO_SIDED|95.0|-6.01|5.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.24|-6.01|0.893
73854271|NCT01942668|147255678|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.058||0.83|TWO_SIDED|95.0|-4.48|3.59||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.59|-4.48|0.830
73854272|NCT01942668|147255678|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|2.05||0.755|TWO_SIDED|95.0|-4.66|3.38||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.38|-4.66|0.755
73854273|NCT01942668|147255678|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.046||0.802|TWO_SIDED|95.0|-3.5|4.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.53|-3.50|0.802
73854274|NCT01942668|147255678|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|2.043||0.823|TWO_SIDED|95.0|-4.46|3.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||3.55|-4.46|0.823
73854275|NCT01942668|147255679|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|2.166||0.255|TWO_SIDED|95.0|-6.71|1.78||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||1.78|-6.71|0.255
73854276|NCT01942668|147255679|SUPERIORITY||Mean Difference (Final Values)|-2.27|STANDARD_ERROR_OF_MEAN|2.154||0.293|TWO_SIDED|95.0|-6.49|1.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||1.96|-6.49|0.293
73854277|NCT01942668|147255679|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|2.148||0.502|TWO_SIDED|95.0|-5.66|2.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.77|-5.66|0.502
73854278|NCT01942668|147255679|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|2.161||0.495|TWO_SIDED|95.0|-5.71|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.76|-5.71|0.495
73854279|NCT01942668|147255680|SUPERIORITY||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|2.274||0.389|TWO_SIDED|95.0|-6.42|2.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.50|-6.42|0.389
73854280|NCT01942668|147255680|SUPERIORITY||Mean Difference (Final Values)|-2.43|STANDARD_ERROR_OF_MEAN|2.253||0.281|TWO_SIDED|95.0|-6.85|1.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||1.99|-6.85|0.281
73854281|NCT01942668|147255680|SUPERIORITY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|2.25||0.504|TWO_SIDED|95.0|-5.92|2.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.91|-5.92|0.504
73854282|NCT01942668|147255680|SUPERIORITY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|2.277||0.46|TWO_SIDED|95.0|-6.15|2.78||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.78|-6.15|0.460
73854283|NCT01942668|147255681|SUPERIORITY||Mean Difference (Final Values)|4.35|STANDARD_ERROR_OF_MEAN|2.513||0.084|TWO_SIDED|95.0|-0.58|9.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.28|-0.58|0.084
73854284|NCT01942668|147255681|SUPERIORITY||Mean Difference (Final Values)|2.61|STANDARD_ERROR_OF_MEAN|2.506||0.298|TWO_SIDED|95.0|-2.3|7.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.53|-2.30|0.298
73854285|NCT01942668|147255681|SUPERIORITY||Mean Difference (Final Values)|3.72|STANDARD_ERROR_OF_MEAN|2.496||0.136|TWO_SIDED|95.0|-1.17|8.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||8.62|-1.17|0.136
73854286|NCT01942668|147255681|SUPERIORITY||Mean Difference (Final Values)|3.48|STANDARD_ERROR_OF_MEAN|2.492||0.163|TWO_SIDED|95.0|-1.41|8.37||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||8.37|-1.41|0.163
73854287|NCT01942668|147255682|SUPERIORITY||Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|2.647||0.054|TWO_SIDED|95.0|-0.08|10.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||10.31|-0.08|0.054
73854288|NCT01942668|147255682|SUPERIORITY||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|2.634||0.007|TWO_SIDED|95.0|1.93|12.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||12.26|1.93|0.007
73854289|NCT01942668|147255682|SUPERIORITY||Mean Difference (Final Values)|5.9|STANDARD_ERROR_OF_MEAN|2.623||0.025|TWO_SIDED|95.0|0.75|11.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||11.04|0.75|0.025
73854290|NCT01942668|147255682|SUPERIORITY||Mean Difference (Final Values)|8.38|STANDARD_ERROR_OF_MEAN|2.638||0.002|TWO_SIDED|95.0|3.2|13.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||13.55|3.20|0.002
73854291|NCT01942668|147255683|SUPERIORITY||Mean Difference (Final Values)|5.02|STANDARD_ERROR_OF_MEAN|2.945||0.089|TWO_SIDED|95.0|-0.76|10.8||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||10.80|-0.76|0.089
73854292|NCT01942668|147255683|SUPERIORITY||Mean Difference (Final Values)|7.56|STANDARD_ERROR_OF_MEAN|2.92||0.01|TWO_SIDED|95.0|1.83|13.29||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||13.29|1.83|0.010
73854293|NCT01942668|147255683|SUPERIORITY||Mean Difference (Final Values)|7.65|STANDARD_ERROR_OF_MEAN|2.911||0.009|TWO_SIDED|95.0|1.94|13.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||13.36|1.94|0.009
73854294|NCT01942668|147255683|SUPERIORITY||Mean Difference (Final Values)|7.89|STANDARD_ERROR_OF_MEAN|2.944||0.007|TWO_SIDED|95.0|2.11|13.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||13.67|2.11|0.007
73854295|NCT01942668|147255684|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|1.749||0.349|TWO_SIDED|95.0|-5.07|1.79||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.79|-5.07|0.349
73854296|NCT01942668|147255684|SUPERIORITY||Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|1.743||0.499|TWO_SIDED|95.0|-4.6|2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||2.24|-4.60|0.499
73854297|NCT01942668|147255684|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.737||0.936|TWO_SIDED|95.0|-3.27|3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||3.55|-3.27|0.936
73854298|NCT01942668|147255684|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.736||0.696|TWO_SIDED|95.0|-4.08|2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.72|-4.08|0.696
73854299|NCT01942668|147255685|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.924||0.572|TWO_SIDED|95.0|-4.86|2.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.69|-4.86|0.572
74088298|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|0.62||||0.006|TWO_SIDED|95.0|0.45|0.87|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.87|0.45|0.0060
73854300|NCT01942668|147255685|SUPERIORITY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|1.914||0.553|TWO_SIDED|95.0|-4.89|2.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.62|-4.89|0.553
73854301|NCT01942668|147255685|SUPERIORITY||Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|1.907||0.456|TWO_SIDED|95.0|-5.16|2.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.32|-5.16|0.456
73854302|NCT01942668|147255685|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|1.919||0.949|TWO_SIDED|95.0|-3.89|3.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.64|-3.89|0.949
73854303|NCT01942668|147255686|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|2.026||0.097|TWO_SIDED|95.0|-7.34|0.61||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.61|-7.34|0.097
73854304|NCT01942668|147255686|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.01||0.008|TWO_SIDED|95.0|-9.28|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.40|-9.28|0.008
73854305|NCT01942668|147255686|SUPERIORITY||Mean Difference (Final Values)|-4.94|STANDARD_ERROR_OF_MEAN|2.003||0.014|TWO_SIDED|95.0|-8.87|-1.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.01|-8.87|0.014
73854306|NCT01942668|147255686|SUPERIORITY||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|2.029||0.056|TWO_SIDED|95.0|-7.86|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.10|-7.86|0.056
73854307|NCT01942668|147255687|SUPERIORITY||Mean Difference (Final Values)|-4.92|STANDARD_ERROR_OF_MEAN|1.665||0.003|TWO_SIDED|95.0|-8.18|-1.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.65|-8.18|0.003
73854308|NCT01942668|147255687|SUPERIORITY||Mean Difference (Final Values)|-3.79|STANDARD_ERROR_OF_MEAN|1.66||0.023|TWO_SIDED|95.0|-7.05|-0.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.53|-7.05|0.023
73854309|NCT01942668|147255687|SUPERIORITY||Mean Difference (Final Values)|-3.28|STANDARD_ERROR_OF_MEAN|1.653||0.047|TWO_SIDED|95.0|-6.52|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.04|-6.52|0.047
73854310|NCT01942668|147255687|SUPERIORITY||Mean Difference (Final Values)|-3.41|STANDARD_ERROR_OF_MEAN|1.652||0.039|TWO_SIDED|95.0|-6.65|-0.17||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.17|-6.65|0.039
73854311|NCT01942668|147255688|SUPERIORITY||Mean Difference (Final Values)|-5.69|STANDARD_ERROR_OF_MEAN|1.713|<|0.001|TWO_SIDED|95.0|-9.05|-2.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.33|-9.05|<0.001
73854312|NCT01942668|147255688|SUPERIORITY||Mean Difference (Final Values)|-5.58|STANDARD_ERROR_OF_MEAN|1.704||0.001|TWO_SIDED|95.0|-8.93|-2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.24|-8.93|0.001
73854313|NCT01942668|147255688|SUPERIORITY||Mean Difference (Final Values)|-5.12|STANDARD_ERROR_OF_MEAN|1.697||0.003|TWO_SIDED|95.0|-8.45|-1.79||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.79|-8.45|0.003
73854314|NCT01942668|147255688|SUPERIORITY||Mean Difference (Final Values)|-5.11|STANDARD_ERROR_OF_MEAN|1.708||0.003|TWO_SIDED|95.0|-8.46|-1.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.76|-8.46|0.003
73854315|NCT01942668|147255689|SUPERIORITY||Mean Difference (Final Values)|-6.01|STANDARD_ERROR_OF_MEAN|1.885||0.001|TWO_SIDED|95.0|-9.71|-2.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.32|-9.71|0.001
73854316|NCT01942668|147255689|SUPERIORITY||Mean Difference (Final Values)|-7.22|STANDARD_ERROR_OF_MEAN|1.871|<|0.001|TWO_SIDED|95.0|-10.89|-3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.55|-10.89|<0.001
73904297|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.9037|TWO_SIDED|95.0|-0.113|0.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.100|-0.113|0.9037
73904298|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.2082|TWO_SIDED|95.0|-0.04|0.181||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.181|-0.040|0.2082
73854317|NCT01942668|147255689|SUPERIORITY||Mean Difference (Final Values)|-6.92|STANDARD_ERROR_OF_MEAN|1.863|<|0.001|TWO_SIDED|95.0|-10.58|-3.27||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.27|-10.58|<0.001
73854318|NCT01942668|147255689|SUPERIORITY||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.886|<|0.001|TWO_SIDED|95.0|-10.12|-2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.72|-10.12|<0.001
73854319|NCT01942668|147255690|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.609||0.004|TWO_SIDED|95.0|-7.75|-1.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.44|-7.75|0.004
73854320|NCT01942668|147255690|SUPERIORITY||Mean Difference (Final Values)|-3.49|STANDARD_ERROR_OF_MEAN|1.605||0.03|TWO_SIDED|95.0|-6.64|-0.34||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.34|-6.64|0.030
73854321|NCT01942668|147255690|SUPERIORITY||Mean Difference (Final Values)|-3.15|STANDARD_ERROR_OF_MEAN|1.598||0.049|TWO_SIDED|95.0|-6.29|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.02|-6.29|0.049
73854322|NCT01942668|147255690|SUPERIORITY||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|1.597||0.121|TWO_SIDED|95.0|-5.61|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.65|-5.61|0.121
73854323|NCT01942668|147255691|SUPERIORITY||Mean Difference (Final Values)|-5.44|STANDARD_ERROR_OF_MEAN|1.682||0.001|TWO_SIDED|95.0|-8.74|-2.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.14|-8.74|0.001
73854324|NCT01942668|147255691|SUPERIORITY||Mean Difference (Final Values)|-5.53|STANDARD_ERROR_OF_MEAN|1.674|<|0.001|TWO_SIDED|95.0|-8.81|-2.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.25|-8.81|<0.001
73904299|NCT01227564|147338832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.5044|TWO_SIDED|95.0|-0.063|0.127||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.127|-0.063|0.5044
73904300|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.7687|TWO_SIDED|95.0|-0.23|0.17||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.17|-0.23|0.7687
73904301|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.6804|TWO_SIDED|95.0|-0.16|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.24|-0.16|0.6804
73904302|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9452|TWO_SIDED|95.0|-0.17|0.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.18|-0.17|0.9452
73904303|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8825|TWO_SIDED|95.0|-0.27|0.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.23|-0.27|0.8825
73962546|NCT02528188|147460967|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15||0.5785|TWO_SIDED|95.0|-0.21|0.38|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.38|-0.21|0.5785
73854325|NCT01942668|147255691|SUPERIORITY||Mean Difference (Final Values)|-5.12|STANDARD_ERROR_OF_MEAN|1.667||0.002|TWO_SIDED|95.0|-8.39|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.85|-8.39|0.002
73854326|NCT01942668|147255691|SUPERIORITY||Mean Difference (Final Values)|-4.64|STANDARD_ERROR_OF_MEAN|1.677||0.006|TWO_SIDED|95.0|-7.93|-1.35||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.35|-7.93|0.006
73854327|NCT01942668|147255692|SUPERIORITY||Mean Difference (Final Values)|-6.28|STANDARD_ERROR_OF_MEAN|1.849|<|0.001|TWO_SIDED|95.0|-9.91|-2.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.65|-9.91|<0.001
73854328|NCT01942668|147255692|SUPERIORITY||Mean Difference (Final Values)|-7.58|STANDARD_ERROR_OF_MEAN|1.835|<|0.001|TWO_SIDED|95.0|-11.18|-3.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.98|-11.18|<0.001
73854329|NCT01942668|147255692|SUPERIORITY||Mean Difference (Final Values)|-7.43|STANDARD_ERROR_OF_MEAN|1.828|<|0.001|TWO_SIDED|95.0|-11.02|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.84|-11.02|<0.001
73854330|NCT01942668|147255692|SUPERIORITY||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|1.851|<|0.001|TWO_SIDED|95.0|-10.17|-2.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.91|-10.17|<0.001
73854331|NCT01942668|147255693|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.049||0.225|TWO_SIDED|95.0|-0.04|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.04|0.225
73854332|NCT01942668|147255693|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.049||0.741|TWO_SIDED|95.0|-0.08|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.08|0.741
73854333|NCT01942668|147255693|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.049||0.414|TWO_SIDED|95.0|-0.06|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.06|0.414
73854334|NCT01942668|147255693|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.049||0.69|TWO_SIDED|95.0|-0.11|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.08|-0.11|0.690
73854335|NCT01942668|147255694|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.052||0.045|TWO_SIDED|95.0|0.0|0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.21|0.00|0.045
73854336|NCT01942668|147255694|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.052||0.069|TWO_SIDED|95.0|-0.01|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.20|-0.01|0.069
73854337|NCT01942668|147255694|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.052||0.126|TWO_SIDED|95.0|-0.02|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.02|0.126
73854338|NCT01942668|147255694|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.052||0.907|TWO_SIDED|95.0|-0.1|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.11|-0.10|0.907
73854339|NCT01942668|147255695|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.055||0.992|TWO_SIDED|95.0|-0.11|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.11|-0.11|0.992
73904304|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8791|TWO_SIDED|95.0|-0.28|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.24|-0.28|0.8791
73904305|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.8628|TWO_SIDED|95.0|-0.24|0.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.20|-0.24|0.8628
73854340|NCT01942668|147255695|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.054||0.45|TWO_SIDED|95.0|-0.07|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.07|0.450
73854341|NCT01942668|147255695|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.054||0.663|TWO_SIDED|95.0|-0.13|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.13|0.663
73854342|NCT01942668|147255695|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.055||0.309|TWO_SIDED|95.0|-0.16|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.05|-0.16|0.309
73854343|NCT04115748|147255696|SUPERIORITY||Difference in response rates|32.1||||0.048|TWO_SIDED|95.0|2.6|61.6||The stratification factors (Geographic Region, Concurrent Use of conventional synthetic (cs) DMARD(s) and/or Apremilast at Randomization, Prior Use of biologic (bio) DMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||61.6|2.6|0.048
73854344|NCT04115748|147255696|SUPERIORITY||Difference in response rates|18.4||||0.23|TWO_SIDED|95.0|-12.4|49.2||The stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||49.2|-12.4|0.23
73854345|NCT04115748|147255698|SUPERIORITY||Difference in response rates|16.1||||0.17|TWO_SIDED|95.0|-9.7|41.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||41.9|-9.7|0.17
73854346|NCT04115748|147255698|SUPERIORITY||Difference in response rates|11.7||||0.27|TWO_SIDED|95.0|-13.3|36.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||36.6|-13.3|0.27
73854347|NCT04115748|147255698|SUPERIORITY||Difference in response rates|10.5||||0.42|TWO_SIDED|95.0|-20.4|41.5||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||41.5|-20.4|0.42
73854348|NCT04115748|147255698|SUPERIORITY||Difference in response rates|15.8||||0.26|TWO_SIDED|95.0|-16.0|47.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.6|-16.0|0.26
73854349|NCT04115748|147255698|SUPERIORITY||Difference in response rates|28.7||||0.062|TWO_SIDED|95.0|-5.0|62.3||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||62.3|-5.0|0.062
73854350|NCT04115748|147255698|SUPERIORITY||Difference in response rates|31.6||||0.047|TWO_SIDED|95.0|-1.5|64.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||64.6|-1.5|0.047
73854351|NCT04115748|147255698|SUPERIORITY||Difference in response rates|7.8||||0.58|TWO_SIDED|95.0|-24.6|40.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.2|-24.6|0.58
73854352|NCT04115748|147255698|SUPERIORITY||Difference in response rates|16.8||||0.27|TWO_SIDED|95.0|-16.2|49.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||49.9|-16.2|0.27
73854353|NCT04115748|147255699|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-9.9|20.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.4|-9.9|
73854354|NCT04115748|147255699|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
73854355|NCT04115748|147255699|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-27.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||17.1|-27.6|
73854356|NCT04115748|147255699|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-29.6|8.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||8.5|-29.6|
73854357|NCT04115748|147255699|SUPERIORITY||Difference in response rates|5.8|||||TWO_SIDED|95.0|-17.2|28.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||28.9|-17.2|
73854358|NCT04115748|147255699|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-19.5|19.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||19.5|-19.5|
73854359|NCT04115748|147255699|SUPERIORITY||Difference in response rates|5.6|||||TWO_SIDED|95.0|-10.3|21.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.4|-10.3|
73854360|NCT04115748|147255699|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-8.4|29.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||29.5|-8.4|
73854361|NCT04115748|147255705|SUPERIORITY||Difference in response rates|16.1|||||TWO_SIDED|95.0|-9.7|41.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||41.9|-9.7|
73854362|NCT04115748|147255705|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-16.5|28.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||28.8|-16.5|
73854363|NCT04115748|147255705|SUPERIORITY||Difference in response rates|23.9|||||TWO_SIDED|95.0|-8.8|56.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||56.6|-8.8|
73854364|NCT04115748|147255705|SUPERIORITY||Difference in response rates|27.1|||||TWO_SIDED|95.0|-5.2|59.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||59.4|-5.2|
73854365|NCT04115748|147255706|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.1|5.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.1|-5.1|
73854366|NCT04115748|147255706|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
73854367|NCT04115748|147255706|SUPERIORITY||Difference in response rates|11.7|||||TWO_SIDED|95.0|-13.3|36.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||36.6|-13.3|
73904306|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7843|TWO_SIDED|95.0|-0.35|0.26||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.26|-0.35|0.7843
73904307|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.0857|TWO_SIDED|95.0|-0.04|0.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.60|-0.04|0.0857
73904308|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.3878|TWO_SIDED|95.0|-0.15|0.39||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.39|-0.15|0.3878
74024881|NCT01309737|147602232|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.44|STANDARD_ERROR_OF_MEAN|13.62||0.0062|TWO_SIDED|95.0|-64.19|-10.68||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-10.68|-64.19|0.0062
74088299|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9449|TWO_SIDED|95.0|0.72|1.42|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.42|0.72|0.9449
73854368|NCT04115748|147255706|SUPERIORITY||Difference in response rates|5.5|||||TWO_SIDED|95.0|-16.4|27.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.4|-16.4|
73854369|NCT04115748|147255707|SUPERIORITY||Difference in response rates|15.8||||0.2|TWO_SIDED|95.0|-13.6|45.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||45.2|-13.6|0.20
73962547|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.74||0.4303|TWO_SIDED|95.0|-0.87|2.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.04|-0.87|0.4303
73854370|NCT04115748|147255707|SUPERIORITY||Difference in response rates|-5.0||||0.6|TWO_SIDED|95.0|-27.8|17.8||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||17.8|-27.8|0.60
73854371|NCT04115748|147255707|SUPERIORITY||Difference in response rates|42.6||||0.008|TWO_SIDED|95.0|11.5|73.8||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||73.8|11.5|0.008
73854372|NCT04115748|147255707|SUPERIORITY||Difference in response rates|17.8||||0.17|TWO_SIDED|95.0|-12.0|47.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||47.6|-12.0|0.17
73854373|NCT04115748|147255707|SUPERIORITY||Difference in response rates|42.1||||0.011|TWO_SIDED|95.0|8.1|76.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||76.2|8.1|0.011
73854374|NCT04115748|147255707|SUPERIORITY||Difference in response rates|5.3||||0.69|TWO_SIDED|95.0|-30.1|40.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||40.6|-30.1|0.69
73854375|NCT04115748|147255707|SUPERIORITY||Difference in response rates|35.7||||0.033|TWO_SIDED|95.0|0.9|70.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||70.4|0.9|0.033
74024882|NCT01309737|147602232|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.79|STANDARD_ERROR_OF_MEAN|13.75||0.0025|TWO_SIDED|95.0|-68.8|-14.78||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-14.78|-68.80|0.0025
74024883|NCT01309737|147602232|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.35|STANDARD_ERROR_OF_MEAN|10.98||0.692|TWO_SIDED|95.0|-25.91|17.21|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||17.21|-25.91|0.6920
74024884|NCT01309737|147602236|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73854376|NCT04115748|147255707|SUPERIORITY||Difference in response rates|21.1||||0.19|TWO_SIDED|95.0|-15.2|57.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.4|-15.2|0.19
73854377|NCT04115748|147255707|SUPERIORITY||Difference in response rates|43.9||||0.007|TWO_SIDED|95.0|12.4|75.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||75.4|12.4|0.007
73854378|NCT04115748|147255707|SUPERIORITY||Difference in response rates|7.6||||0.63|TWO_SIDED|95.0|-28.8|44.1||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||44.1|-28.8|0.63
73854379|NCT04115748|147255708|SUPERIORITY||Difference in response rates|0.0||||0.98|TWO_SIDED|95.0|-19.5|19.5||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.5|-19.5|0.98
73854380|NCT04115748|147255708|SUPERIORITY||Difference in response rates|-5.3||||0.5|TWO_SIDED|95.0|-20.7|10.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.2|-20.7|0.50
73854381|NCT04115748|147255708|SUPERIORITY||Difference in response rates|5.5||||0.54|TWO_SIDED|95.0|-16.4|27.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||27.4|-16.4|0.54
73854382|NCT04115748|147255708|SUPERIORITY||Difference in response rates|0.6||||0.92|TWO_SIDED|95.0|-19.0|20.1||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.1|-19.0|0.92
73854383|NCT04115748|147255708|SUPERIORITY||Difference in response rates|21.1||||0.13|TWO_SIDED|95.0|-9.3|51.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||51.4|-9.3|0.13
73854384|NCT04115748|147255708|SUPERIORITY||Difference in response rates|15.8||||0.22|TWO_SIDED|95.0|-13.6|45.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||45.2|-13.6|0.22
73854385|NCT04115748|147255708|SUPERIORITY||Difference in response rates|45.0||||0.007|TWO_SIDED|95.0|12.8|77.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.2|12.8|0.007
73854386|NCT04115748|147255708|SUPERIORITY||Difference in response rates|31.6||||0.039|TWO_SIDED|95.0|0.2|63.0||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||63.0|0.2|0.039
73854387|NCT04115748|147255708|SUPERIORITY||Difference in response rates|12.8||||0.34|TWO_SIDED|95.0|-18.4|44.0||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||44.0|-18.4|0.34
74024885|NCT01309737|147602236|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74024886|NCT01309737|147602236|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74024887|NCT01309737|147602237|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74024888|NCT01309737|147602237|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74024889|NCT01309737|147602237|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73904309|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8918|TWO_SIDED|95.0|-0.39|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.45|-0.39|0.8918
73904310|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.1233|TWO_SIDED|95.0|-0.09|0.76||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.76|-0.09|0.1233
73904311|NCT01227564|147338833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.3302|TWO_SIDED|95.0|-0.19|0.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.55|-0.19|0.3302
74024890|NCT01309737|147602238|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74024891|NCT01309737|147602238|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74024892|NCT01309737|147602238|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74024893|NCT01442181|147602277|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month in minimally invasive group||||0.03
74024894|NCT01442181|147602277|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of the fatigue and energy was done in baseline-3 month, and 6 month in each group. Minimally Invasive: baseline vs 3 month||||0.01
74024895|NCT01442181|147602277|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue in medical therapy group; baseline vs 3 month||||0.49
73904312|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.65||||0.1597|TWO_SIDED|95.0|-0.67|3.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||3.97|-0.67|0.1597
73904313|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.213|TWO_SIDED|95.0|-4.01|0.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.91|-4.01|0.2130
73930726|NCT03238911|147391299|SUPERIORITY||Mean Difference (Final Values)|40.82|||<|0.0001|TWO_SIDED|95.0|26.3|55.33|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||55.33|26.30|<0.0001
74024896|NCT01442181|147602277|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month||||0.06
74024897|NCT01697345|147602317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.092|STANDARD_DEVIATION|6.0378|<|0.0005|TWO_SIDED|95.0|-13.928|-6.256|||t-test, 2 sided|||||-6.256|-13.928|<0.0005
74024898|NCT01697345|147602318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|0.88|<|0.0005|TWO_SIDED|95.0|-1.859|-0.741|||t-test, 2 sided|||||-0.741|-1.859|<0.0005
74024899|NCT01697345|147602319|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.625|STANDARD_DEVIATION|1.369||0.002|TWO_SIDED|95.0|-2.495|-0.755|||t-test, 2 sided|||||-0.755|-2.495|0.002
74024900|NCT01697345|147602320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_DEVIATION|1.876||0.018|TWO_SIDED|95.0|-2.692|-0.308|||t-test, 2 sided|||||-0.308|-2.692|0.018
74024901|NCT01697345|147602321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|1.18168||0.005|TWO_SIDED|95.0|-1.9508|-0.4492|||t-test, 2 sided|||||-.44920|-1.95080|0.005
74024902|NCT01697345|147602322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|1.355||0.001|TWO_SIDED|95.0|-2.761|-1.039|||t-test, 2 sided|||||-1.039|-2.761|0.001
74024903|NCT01697345|147602323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.567|STANDARD_DEVIATION|1.793|<|0.0005|TWO_SIDED|95.0|-3.706|-1.428|||t-test, 2 sided|||||-1.428|-3.706|<0.0005
74024904|NCT01446809|147602343|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
74024905|NCT01446809|147602344|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
74024906|NCT03972488|147602385|SUPERIORITY||Hazard Ratio (HR)|0.276|||<|0.0001|TWO_SIDED|95.0|0.182|0.418|||Log Rank|Stratified one-sided P-value||||0.418|0.182|<0.0001
74024907|NCT03972488|147602386|SUPERIORITY||Stratified Odds Ratio|7.81|||<|0.0001|TWO_SIDED|95.0|3.32|18.4|||Stratified One-sided p-value|||||18.40|3.32|<0.0001
73854388|NCT04115748|147255708|SUPERIORITY||Difference in response rates|32.4||||0.04|TWO_SIDED|95.0|-0.1|64.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||64.9|-0.1|0.040
73854389|NCT04115748|147255709|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-10.0|20.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||20.6|-10.0|
73854390|NCT04115748|147255709|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.4|5.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||5.4|-5.4|
73854391|NCT04115748|147255709|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-9.9|20.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.4|-9.9|
73854392|NCT04115748|147255709|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
73854393|NCT04115748|147255709|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-14.0|35.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||35.0|-14.0|
73854394|NCT04115748|147255709|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-17.1|27.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||27.6|-17.1|
73854395|NCT04115748|147255709|SUPERIORITY||Difference in response rates|27.8|||||TWO_SIDED|95.0|1.7|53.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||53.9|1.7|
73854396|NCT04115748|147255709|SUPERIORITY||Difference in response rates|26.3|||||TWO_SIDED|95.0|1.3|51.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||51.4|1.3|
73854397|NCT04115748|147255709|SUPERIORITY||Difference in response rates|12.2|||||TWO_SIDED|95.0|-16.3|40.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.8|-16.3|
73854398|NCT04115748|147255709|SUPERIORITY||Difference in response rates|21.6|||||TWO_SIDED|95.0|-8.2|51.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||51.4|-8.2|
73854399|NCT04115748|147255717|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-46.3|25.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||25.2|-46.3|
73854400|NCT04115748|147255717|SUPERIORITY||Difference in response rates|-8.8|||||TWO_SIDED|95.0|-45.3|27.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||27.7|-45.3|
73904314|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9616|TWO_SIDED|95.0|-2.06|2.16||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||2.16|-2.06|0.9616
73930727|NCT03238911|147391299|SUPERIORITY||Mean Difference (Final Values)|6.61||||0.0089|TWO_SIDED|95.0|1.69|11.53|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||11.53|1.69|0.0089
73854401|NCT04115748|147255717|SUPERIORITY||Difference in response rates|11.8|||||TWO_SIDED|95.0|-22.1|45.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||45.8|-22.1|
73854402|NCT04115748|147255717|SUPERIORITY||Difference in response rates|19.4|||||TWO_SIDED|95.0|-15.6|54.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||54.5|-15.6|
73854403|NCT04115748|147255717|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-26.0|47.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.0|-26.0|
73854404|NCT04115748|147255717|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-26.0|47.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.0|-26.0|
73854405|NCT04115748|147255717|SUPERIORITY||Difference in response rates|29.8|||||TWO_SIDED|95.0|-6.3|66.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||66.0|-6.3|
73854406|NCT04115748|147255717|SUPERIORITY||Difference in response rates|31.6|||||TWO_SIDED|95.0|-3.8|67.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||67.0|-3.8|
73854407|NCT04115748|147255717|SUPERIORITY||Difference in response rates|5.0|||||TWO_SIDED|95.0|-32.0|42.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||42.0|-32.0|
73854408|NCT04115748|147255717|SUPERIORITY||Difference in response rates|39.2|||||TWO_SIDED|95.0|6.8|71.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||71.6|6.8|
73854409|NCT04115748|147255718|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.8|24.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||24.8|-24.8|
73854410|NCT04115748|147255718|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-24.9|26.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||26.0|-24.9|
73854411|NCT04115748|147255718|SUPERIORITY||Difference in response rates|-4.5|||||TWO_SIDED|95.0|-30.5|21.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||21.5|-30.5|
74024908|NCT03972488|147602387|SUPERIORITY||Hazard Ratio (HR)|0.856||||0.2222|TWO_SIDED|95.0|0.57|1.283|||Log Rank|Stratified one-sided P-value||Global Health Status||1.283|0.570|0.2222
74024909|NCT01614457|147602402|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|2.1114||||0.1979|TWO_SIDED|95.0|-1.1305|5.3532|||Mixed Model Repeated Measures|||Analysis was based on mixed effects model for repeated measures (MMRM) with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, using compound symmetry covariance matrix.||5.3532|-1.1305|0.1979
74024910|NCT01614457|147602403|SUPERIORITY_OR_OTHER||LS Mean difference|0.2626||||0.778|TWO_SIDED|95.0|-1.5698|2.095||p-value for the treatment effect is from the slope of BMI (kg/m2) versus time (days).|Linear Mixed model|||Analysis was based on linear mixed model with dependent variable BMI and treatment as a fixed effect, adjustment for baseline percent predicted FEV1, age and visit by treatment interaction was included as covariates and intercept, visit were included as random effects.||2.0950|-1.5698|0.7780
74024911|NCT01614457|147602404|SUPERIORITY_OR_OTHER||LS Mean difference|-23.9693|||<|0.0001|TWO_SIDED|95.0|-28.0094|-19.9293|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and sweat chloride, using a compound symmetry covariance matrix.||-19.9293|-28.0094|<0.0001
74024912|NCT01614457|147602405|SUPERIORITY_OR_OTHER||LS Mean difference|8.3874||||0.0091|TWO_SIDED|95.0|2.1658|14.609|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and CFQ-R respiratory domain score, using compound symmetry covariance matrix.||14.6090|2.1658|0.0091
74024913|NCT01614457|147602406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.8556|TWO_SIDED||||||Cox Proportional Hazard Regression|||||||0.8556
74024914|NCT01380899|147602433|SUPERIORITY|IHC analyses revealed intense α-synuclein positive immunostaining in PD patients, showing small nodular deposits from 1 to 2 μm in diameter in the SCL of the epidermis including the epidermal component adjacent to hair follicles, and in cells from PSUs, while control subjects presented null immunoreaction. The α-synuclein inclusions in the two groups of patients were morphologically similar but quantitatively different. These inclusions appeared to be juxtanuclear.|Median Difference (Net)|57.9|STANDARD_DEVIATION|8.85|<|0.01|TWO_SIDED|95.0|44.9|62.6||The presence of alpha-synuclein aggregates expressed as % of cells with inclusions was tested for normality (Shapiro-Wilk test). Then, with the nonparametric Kruskal-Wallis followed by Mann-Whitney U tests (software Statistica 7.0 at 95% confidence).|Kruskal-Wallis|The groups were analyzed with Kruskal-Wallis followed by Mann-Whitney U tests.|The expression of the abnormal protein (alpha-synuclein) must be different between the three groups (PD, AP, and control)|The patients were stratified according to the clinical diagnosis made on the basis of the clinical findings, the MRI, and the progression of the disease. Both the clinical diagnosis and the semiquantitative histological analysis were carried out independently and blind to each other. The presence of aggregates of abnormal a-synuclein, expressed as the percentage of cells with positive inclusions in each experimental group, was tested for normality with the Shapiro-Wilk test.|The patients were stratified according to the clinical diagnosis based on the clinical findings, the MRI, and the progression of the disease. Both the clinical diagnosis and the semiquantitative histological analysis were carried out independently and blind to each other. The presence of aggregates of abnormal α-synuclein, expressed as the percentage of cells with positive inclusions in each experimental group, was tested for normality with the Shapiro-Wilk test. Next, the groups were analyzed with the nonparametric Kruskal-Wallis followed by Mann-Whitney U tests. One independent analysis was performed for each structure, namely the epidermis, PSU, and EG. Assessments were performed using the software Statistica 7.0 (Tulsa, OK) at 95% confidence.|62.6|44.9|< 0.01
73904315|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.2143|TWO_SIDED|95.0|-1.06|4.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||4.62|-1.06|0.2143
74024915|NCT01756157|147602442|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.61||||0.0523|TWO_SIDED|95.0|-1.23|0.01|||Paired t-test, 2 sided|||||0.01|-1.23|0.0523
74024916|NCT02799381|147602452|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-15.05|||<|0.0001|TWO_SIDED|95.0|-21.47|-8.63||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|||-8.63|-21.47|<0.0001
74024917|NCT02799381|147602453|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|3.27|||<|0.0001|TWO_SIDED|95.0|1.71|4.83||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||4.83|1.71|<0.0001
74088300|NCT02709486|147730010|SUPERIORITY||Odds Ratio (OR)|0.84||||0.3238|TWO_SIDED|95.0|0.6|1.18|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.18|0.60|0.3238
74088301|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.07||0.0001|TWO_SIDED|95.0|0.54|0.82|||Negative binomial model|||Week 2: Least square (LS) Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.82|0.54|0.0001
73904316|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.2151|TWO_SIDED|95.0|-4.87|1.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.12|-4.87|0.2151
73904317|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.9704|TWO_SIDED|95.0|-2.61|2.51||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.51|-2.61|0.9704
73904318|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.7857|TWO_SIDED|95.0|-3.0|3.95||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||3.95|-3.00|0.7857
73904319|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.79||||0.1323|TWO_SIDED|95.0|-6.45|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.87|-6.45|0.1323
73904320|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.4618|TWO_SIDED|95.0|-4.29|1.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.97|-4.29|0.4618
74024918|NCT02799381|147602454|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-16.66|||<|0.0001|TWO_SIDED|95.0|-24.48|-8.85||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-8.85|-24.48|<0.0001
74088302|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.08||0.0067|TWO_SIDED|95.0|0.61|0.92|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.92|0.61|0.0067
73904321|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.2622|TWO_SIDED|95.0|-1.74|6.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||6.22|-1.74|0.2622
73904322|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.4499|TWO_SIDED|95.0|-5.64|2.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.55|-5.64|0.4499
73904323|NCT01227564|147338834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.8454|TWO_SIDED|95.0|-3.21|3.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.91|-3.21|0.8454
74024919|NCT02799381|147602455|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-2.11|||<|0.0001|TWO_SIDED|95.0|-2.78|-1.44||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-1.44|-2.78|<0.0001
73854412|NCT04115748|147255718|SUPERIORITY||Difference in response rates|12.8|||||TWO_SIDED|95.0|-18.4|44.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||44.0|-18.4|
73854413|NCT04115748|147255718|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-14.1|56.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||56.3|-14.1|
73854414|NCT04115748|147255718|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-33.3|33.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||33.3|-33.3|
73854415|NCT04115748|147255718|SUPERIORITY||Difference in response rates|34.5|||||TWO_SIDED|95.0|-0.3|69.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||69.3|-0.3|
73854416|NCT04115748|147255718|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-13.0|55.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||55.1|-13.0|
73854417|NCT04115748|147255718|SUPERIORITY||Difference in response rates|24.4|||||TWO_SIDED|95.0|-9.7|58.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||58.6|-9.7|
73854418|NCT04115748|147255718|SUPERIORITY||Difference in response rates|32.6|||||TWO_SIDED|95.0|-1.0|66.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||66.2|-1.0|
73854419|NCT04115748|147255720|SUPERIORITY||Difference in response rates|-15.8|||||TWO_SIDED|95.0|-47.6|16.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||16.0|-47.6|
73854420|NCT04115748|147255720|SUPERIORITY||Difference in response rates|-20.5|||||TWO_SIDED|95.0|-51.3|10.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.4|-51.3|
73854421|NCT04115748|147255720|SUPERIORITY||Difference in response rates|6.6|||||TWO_SIDED|95.0|-26.8|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||39.9|-26.8|
73854422|NCT04115748|147255720|SUPERIORITY||Difference in response rates|13.9|||||TWO_SIDED|95.0|-20.8|48.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||48.6|-20.8|
73854423|NCT04115748|147255720|SUPERIORITY||Difference in response rates|15.8|||||TWO_SIDED|95.0|-20.7|52.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||52.3|-20.7|
73854424|NCT04115748|147255720|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-31.0|41.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||41.6|-31.0|
73854425|NCT04115748|147255720|SUPERIORITY||Difference in response rates|24.3|||||TWO_SIDED|95.0|-12.4|60.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||60.9|-12.4|
73854426|NCT04115748|147255720|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-15.2|57.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.4|-15.2|
73854427|NCT04115748|147255720|SUPERIORITY||Difference in response rates|4.4|||||TWO_SIDED|95.0|-32.3|41.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||41.2|-32.3|
73854428|NCT04115748|147255720|SUPERIORITY||Difference in response rates|23.2|||||TWO_SIDED|95.0|-12.5|58.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||58.8|-12.5|
73854429|NCT04115748|147255721|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-19.5|19.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.5|-19.5|
73854430|NCT04115748|147255721|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-20.7|10.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.2|-20.7|
73854431|NCT04115748|147255721|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-18.7|19.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||19.3|-18.7|
73854432|NCT04115748|147255721|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-19.0|20.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.1|-19.0|
73854433|NCT04115748|147255721|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.8|24.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||24.8|-24.8|
73854434|NCT04115748|147255721|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-27.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||17.1|-27.6|
73854435|NCT04115748|147255721|SUPERIORITY||Difference in response rates|17.0|||||TWO_SIDED|95.0|-10.1|44.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||44.0|-10.1|
73854436|NCT04115748|147255721|SUPERIORITY||Difference in response rates|26.3|||||TWO_SIDED|95.0|-2.1|54.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||54.8|-2.1|
73854437|NCT04115748|147255721|SUPERIORITY||Difference in response rates|6.7|||||TWO_SIDED|95.0|-20.3|33.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.6|-20.3|
74024920|NCT02799381|147602456|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-5.54|||=|0.0006|TWO_SIDED|95.0|-8.59|-2.49||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-2.49|-8.59|=0.0006
74024921|NCT02799381|147602457|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-2.35|||=|0.0002|TWO_SIDED|95.0|-3.51|-1.19||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-1.19|-3.51|=0.0002
74024922|NCT02799381|147602458|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-4.05|||=|0.0762|TWO_SIDED|95.0|-8.55|0.44||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||0.44|-8.55|=0.0762
74024923|NCT03952130|147602462|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.07|||||TWO_SIDED|95.0|-0.11|0.24||||||||0.24|-0.11|
74024924|NCT03952130|147602463|SUPERIORITY||LS Mean Difference|-17.8||||0.003|TWO_SIDED|95.0|-29.4|-6.1|||ANCOVA|||||-6.1|-29.4|0.003
74024925|NCT03952130|147602464|SUPERIORITY||LS Mean Difference|-25.5||||0.001|TWO_SIDED|95.0|-41.1|-10.0|||ANCOVA|||||-10.0|-41.1|0.001
74024926|NCT03952130|147602465|OTHER||Relative rate|0.85||||0.834|TWO_SIDED|95.0|0.19|3.77|||Empirical method|||||3.77|0.19|0.834
74024927|NCT03952130|147602466|OTHER||Relative rate|1.0||||0.983|TWO_SIDED|95.0|0.72|1.38|||Negative binomial regression|||\<=30 minutes post meal||1.38|0.72|0.983
74024928|NCT03952130|147602466|OTHER||Relative rate|1.61||||0.076|TWO_SIDED|95.0|0.95|2.74|||Negative binomial regression|||\<=1 hour post meal||2.74|0.95|0.076
73962548|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.75||0.5656|TWO_SIDED|95.0|-1.9|1.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.04|-1.90|0.5656
74024929|NCT03952130|147602466|OTHER||Relative rate|1.19||||0.409|TWO_SIDED|95.0|0.79|1.79|||Negative binomial regression|||\<=2 hours post meal||1.79|0.79|0.409
74024930|NCT03952130|147602466|OTHER||Relative rate|1.22||||0.217|TWO_SIDED|95.0|0.89|1.68|||Negative binomial regression|||\<=4 hours post meal||1.68|0.89|0.217
74024931|NCT03952130|147602466|OTHER||Relative rate|1.09||||0.703|TWO_SIDED|95.0|0.71|1.65|||Negative binomial regression|||\>1 to \<=2 hours post meal||1.65|0.71|0.703
74024932|NCT03952130|147602466|OTHER||Relative rate|1.24||||0.206|TWO_SIDED|95.0|0.89|1.73|||Negative binomial regression|||\>2 to \<=4 hours post meal||1.73|0.89|0.206
74024933|NCT03952130|147602466|OTHER||Relative rate|0.75||||0.082|TWO_SIDED|95.0|0.55|1.04|||Negative binomial regression|||\>4 hours post meal||1.04|0.55|0.082
74024934|NCT03952130|147602467|OTHER||LS Mean Difference|-0.29||||0.309|TWO_SIDED|95.0|-0.86|0.27|||Mixed Models Analysis|||||0.27|-0.86|0.309
74024935|NCT03952130|147602468|OTHER||LS Mean Difference|-15.7|||<|0.001|TWO_SIDED|95.0|-23.8|-7.7|||Mixed Models Analysis|||Morning premeal-fasting||-7.7|-23.8|<.001
74024936|NCT03952130|147602468|OTHER||LS Mean Difference|-14.0||||0.005|TWO_SIDED|95.0|-23.8|-4.2|||Mixed Models Analysis|||Morning 1-hour post meal||-4.2|-23.8|0.005
73854438|NCT04115748|147255721|SUPERIORITY||Difference in response rates|11.1|||||TWO_SIDED|95.0|-16.6|38.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||38.7|-16.6|
74024937|NCT03952130|147602468|OTHER||LS Mean Difference|-14.9||||0.004|TWO_SIDED|95.0|-25.0|-4.8|||Mixed Models Analysis|||Morning 2-hour post meal||-4.8|-25.0|0.004
74024938|NCT03952130|147602468|OTHER||LS Mean Difference|-2.3||||0.616|TWO_SIDED|95.0|-11.4|6.8|||Mixed Models Analysis|||Midday premeal||6.8|-11.4|0.616
73962549|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.92||0.976|TWO_SIDED|95.0|-1.78|1.83|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.83|-1.78|0.9760
74024939|NCT03952130|147602468|OTHER||LS Mean Difference|-9.1||||0.054|TWO_SIDED|95.0|-18.4|0.1|||Mixed Models Analysis|||Midday 1-hour post meal||0.1|-18.4|0.054
74024940|NCT03952130|147602468|OTHER||LS Mean Difference|-3.3||||0.483|TWO_SIDED|95.0|-12.6|6.0|||Mixed Models Analysis|||Midday 2-hour post meal||6.0|-12.6|0.483
74024941|NCT03952130|147602468|OTHER||LS Mean Difference|10.5||||0.064|TWO_SIDED|95.0|-0.6|21.7|||Mixed Models Analysis|||Evening premeal||21.7|-0.6|0.064
74024942|NCT03952130|147602468|OTHER||LS Mean Difference|-5.6||||0.262|TWO_SIDED|95.0|-15.5|4.2|||Mixed Models Analysis|||Evening 1-hour post meal||4.2|-15.5|0.262
74024943|NCT03952130|147602468|OTHER||LS Mean Difference|-7.8||||0.117|TWO_SIDED|95.0|-17.5|2.0|||Mixed Models Analysis|||Evening 2-hour post meal||2.0|-17.5|0.117
73904324|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.1796|TWO_SIDED|95.0|-0.18|0.96||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.96|-0.18|0.1796
73904325|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.7281|TWO_SIDED|95.0|-0.49|0.69||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.69|-0.49|0.7281
73904326|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.3347|TWO_SIDED|95.0|-0.26|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.75|-0.26|0.3347
73904327|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.3425|TWO_SIDED|95.0|-0.43|1.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.20|-0.43|0.3425
73904328|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.4501|TWO_SIDED|95.0|-1.16|0.52||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.52|-1.16|0.4501
73904329|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.9227|TWO_SIDED|95.0|-0.68|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.75|-0.68|0.9227
73904330|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.345|TWO_SIDED|95.0|-0.51|1.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.45|-0.51|0.3450
73904331|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.274|TWO_SIDED|95.0|-1.58|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.45|-1.58|0.2740
73962550|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.93||0.5678|TWO_SIDED|95.0|-1.3|2.36|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.36|-1.30|0.5678
73962551|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|1.76||0.6974|TWO_SIDED|95.0|-2.77|4.14|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.14|-2.77|0.6974
74024944|NCT03952130|147602468|OTHER||LS Mean Difference|-4.4||||0.414|TWO_SIDED|95.0|-15.1|6.2|||Mixed Models Analysis|||Bedtime||6.2|-15.1|0.414
74024945|NCT03952130|147602469|OTHER||LS Mean Difference|0.0||||0.947|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||Basal insulin dose||0.6|-0.7|0.947
74024946|NCT03952130|147602469|OTHER||LS Mean Difference|0.7||||0.5|TWO_SIDED|95.0|-1.3|2.6|||Mixed Models Analysis|||Bolus insulin dose||2.6|-1.3|0.500
74024947|NCT03952130|147602469|OTHER||LS Mean Difference|0.6||||0.543|TWO_SIDED|95.0|-1.4|2.7|||Mixed Models Analysis|||Total insulin dose||2.7|-1.4|0.543
74024948|NCT03952130|147602470|OTHER||Odds Ratio (OR)|0.81||||0.462|TWO_SIDED|95.0|0.47|1.42|||Regression, Logistic|||For HbA1c \< 7%||1.42|0.47|0.462
74024949|NCT03952130|147602470|OTHER||Odds Ratio (OR)|0.54||||0.089|TWO_SIDED|95.0|0.26|1.1|||Regression, Logistic|||For HbA1c ≤6.5%||1.10|0.26|0.089
74024950|NCT01713348|147602471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|3.3||0.9345|TWO_SIDED|95.0|-1.29|1.19|||t-test, 2 sided|||||1.19|-1.29|0.9345
74024951|NCT01713348|147602471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|3.5||0.0427|TWO_SIDED|95.0|0.05|2.73|||t-test, 2 sided|||Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.||2.73|0.05|0.0427
74024952|NCT01713348|147602472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|1.18||0.8367|TWO_SIDED|95.0|-2.65|2.16|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.||||2.16|-2.65|0.8367
74024953|NCT01713348|147602472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_DEVIATION|1.05||0.7969|TWO_SIDED|95.0|-1.86|2.4|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.||||2.40|-1.86|0.7969
74024954|NCT01713348|147602473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.6||0.0352|TWO_SIDED|95.0|-0.51|-0.02|||t-test, 2 sided|||||-0.02|-0.51|0.0352
74088303|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.64|STANDARD_ERROR_OF_MEAN|0.08||0.0003|TWO_SIDED|95.0|0.51|0.82|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.82|0.51|0.0003
73854439|NCT04115748|147255723|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-34.8|34.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||34.8|-34.8|
73854440|NCT04115748|147255723|SUPERIORITY||Difference in response rates|-14.9|||||TWO_SIDED|95.0|-47.4|17.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||17.6|-47.4|
73854441|NCT04115748|147255723|SUPERIORITY||Difference in response rates|27.9|||||TWO_SIDED|95.0|-7.2|63.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||63.0|-7.2|
73854442|NCT04115748|147255723|SUPERIORITY||Difference in response rates|8.9|||||TWO_SIDED|95.0|-26.6|44.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||44.3|-26.6|
73854443|NCT04115748|147255723|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-13.0|55.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||55.1|-13.0|
73854444|NCT04115748|147255723|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-47.4|26.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||26.3|-47.4|
73854445|NCT04115748|147255723|SUPERIORITY||Difference in response rates|24.9|||||TWO_SIDED|95.0|-11.1|60.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||60.8|-11.1|
73854446|NCT04115748|147255723|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-14.9|57.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.0|-14.9|
73854447|NCT04115748|147255723|SUPERIORITY||Difference in response rates|43.9|||||TWO_SIDED|95.0|12.4|75.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||75.4|12.4|
73854448|NCT04115748|147255723|SUPERIORITY||Difference in response rates|12.9|||||TWO_SIDED|95.0|-23.4|49.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||49.1|-23.4|
73854449|NCT04115748|147255725|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-14.8|89.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||89.8|-14.8|
73854450|NCT04115748|147255725|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||100.0|-25.4|
73854451|NCT04115748|147255725|SUPERIORITY||Difference in response rates|-25.0|||||TWO_SIDED|95.0|-100.0|51.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||51.2|-100.0|
73854452|NCT04115748|147255725|SUPERIORITY||Difference in response rates|-10.0|||||TWO_SIDED|95.0|-97.7|77.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||77.7|-97.7|
73854453|NCT04115748|147255725|SUPERIORITY||Difference in response rates|7.1|||||TWO_SIDED|95.0|-73.7|88.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||88.0|-73.7|
73854454|NCT04115748|147255725|SUPERIORITY||Difference in response rates|-10.0|||||TWO_SIDED|95.0|-97.7|77.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.7|-97.7|
73854455|NCT04115748|147255725|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-35.3|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||100.0|-35.3|
74024955|NCT01713348|147602473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.7||0.0506|TWO_SIDED|95.0|-0.54|0.0|||t-test, 2 sided|||||0.00|-0.54|0.0506
74024956|NCT01713348|147602474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|8.0||0.058|TWO_SIDED|95.0|-6.4|0.1|||t-test, 2 sided|||||0.1|-6.4|0.0580
74024957|NCT01713348|147602474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_DEVIATION|12.0||0.0002|TWO_SIDED|95.0|-13.6|-4.9|||t-test, 2 sided|||||-4.9|-13.6|0.0002
74024958|NCT01713348|147602475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.8||0.058|TWO_SIDED|95.0|-0.59|0.01|||t-test, 2 sided|||||0.01|-0.59|0.0580
74024959|NCT01713348|147602475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|1.1||0.0002|TWO_SIDED|95.0|-1.24|-0.45|||t-test, 2 sided|||||-0.45|-1.24|0.0002
74024960|NCT04425850|147602476|OTHER||||||<|0.0001|||||||Chi-squared|||Chi-squared test on the percentage of subjects who contracted COVID-19 in each arm||||< 0.0001
74024961|NCT01584024|147602492|SUPERIORITY||||||=|0.003|||||||McNemar|||||||=0.003
74024962|NCT01584024|147602493|SUPERIORITY||||||=|0.17|||||||McNemar|||||||=0.17
73854456|NCT04115748|147255725|SUPERIORITY||Difference in response rates|15.0|||||TWO_SIDED|95.0|-67.9|97.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||97.9|-67.9|
73854457|NCT04115748|147255726|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||54.2|-29.2|
73854458|NCT04115748|147255726|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||77.6|-37.6|
73854459|NCT04115748|147255726|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-23.8|73.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||73.8|-23.8|
73854460|NCT04115748|147255726|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||100.0|-25.4|
73854461|NCT04115748|147255726|SUPERIORITY||Difference in response rates|42.9|||||TWO_SIDED|95.0|-13.4|99.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||99.2|-13.4|
73854462|NCT04115748|147255726|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||100.0|-25.4|
73904332|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.914|TWO_SIDED|95.0|-0.92|0.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.82|-0.92|0.9140
73854463|NCT04115748|147255726|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-35.3|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||100.0|-35.3|
73854464|NCT04115748|147255726|SUPERIORITY||Difference in response rates|-5.0|||||TWO_SIDED|95.0|-82.5|72.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||72.5|-82.5|
73854465|NCT04115748|147255727|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||18.8|-18.8|
73854466|NCT04115748|147255727|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.5|-22.5|
73854467|NCT04115748|147255727|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||54.2|-29.2|
73854468|NCT04115748|147255727|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.5|-22.5|
73854469|NCT04115748|147255727|SUPERIORITY||Difference in response rates|14.3|||||TWO_SIDED|95.0|-31.3|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-31.3|
73854470|NCT04115748|147255727|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.6|-37.6|
73854471|NCT04115748|147255727|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-23.8|73.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||73.8|-23.8|
73854472|NCT04115748|147255727|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||77.6|-37.6|
73854473|NCT04115748|147255728|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||18.8|-18.8|
73854474|NCT04115748|147255728|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.5|-22.5|
73854475|NCT04115748|147255728|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||18.8|-18.8|
73854476|NCT04115748|147255728|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.5|-22.5|
73854477|NCT04115748|147255728|SUPERIORITY||Difference in response rates|14.3|||||TWO_SIDED|95.0|-31.3|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-31.3|
73854478|NCT04115748|147255728|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||22.5|-22.5|
73854479|NCT04115748|147255728|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||54.2|-29.2|
73854480|NCT04115748|147255728|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||77.6|-37.6|
73854481|NCT04115748|147255732|SUPERIORITY||LS Mean Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.104||0.94|TWO_SIDED|95.0|-0.22|0.2||P-value was calculated from mixed-effects model for repeated measures (MMRM) including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 2||0.20|-0.22|0.94
74024963|NCT04419506|147602502|OTHER||Posterior difference|88.4|||||TWO_SIDED|95.0|29.5|154.2|||||Difference calculated as BI 1015550 - Placebo|Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.||154.2|29.5|
74024964|NCT04419506|147602502|OTHER||Posterior difference|62.4|||||TWO_SIDED|95.0|6.3|125.5|||||Difference calculated as BI 1015550 - Placebo|Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.||125.5|6.3|
74024965|NCT02966314|147602518|SUPERIORITY||Odds Ratio (OR)|18.7||||0.003|TWO_SIDED|95.0|2.77|126.47|||Regression, Logistic|Accounting for repeated measures||||126.47|2.77|0.003
74024966|NCT02966314|147602520|SUPERIORITY||Mean Difference (Final Values)|9.43||||0.03|TWO_SIDED|95.0|1.24|17.63|||Regression, Linear|||||17.63|1.24|0.03
74024967|NCT02966314|147602522|SUPERIORITY||Odds Ratio (OR)|32.8||||0.03|TWO_SIDED|95.0|1.49|720.54|||Regression, Logistic|Accounting for repeated measures||||720.54|1.49|0.03
74024968|NCT02966314|147602524|SUPERIORITY||Risk Ratio (RR)|6.9||||0.005|TWO_SIDED|95.0|1.9|25.3|||Regression, Linear|Accounting for multiple measures, using poisson distribution with natural log link||||25.3|1.9|0.005
74024969|NCT02015819|147602535|OTHER||||||||||||||||||MFD was determined to be 1.5x10\^8 in combination with oral 5-FC 37.5 mg/kg and leucovorin 25 mg every 6 hours for 7 days.|||
74088304|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.09||0.0112|TWO_SIDED|95.0|0.58|0.93|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.93|0.58|0.0112
73854482|NCT04115748|147255732|SUPERIORITY||LS Mean Treatment Difference|0.03|STANDARD_ERROR_OF_MEAN|0.105||0.81|TWO_SIDED|95.0|-0.18|0.24||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 2||0.24|-0.18|0.81
73854483|NCT04115748|147255732|SUPERIORITY||LS Mean Treatment Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.112||0.13|TWO_SIDED|95.0|-0.39|0.05||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||0.05|-0.39|0.13
73854484|NCT04115748|147255732|SUPERIORITY||LS Mean Treatment Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.113||0.073|TWO_SIDED|95.0|-0.43|0.02||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||0.02|-0.43|0.073
73854485|NCT04115748|147255732|SUPERIORITY||LS Mean Treatment Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.124||0.083|TWO_SIDED|95.0|-0.46|0.03||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 8||0.03|-0.46|0.083
73854486|NCT04115748|147255732|SUPERIORITY||LS Mean Treatment Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124||0.28|TWO_SIDED|95.0|-0.38|0.11||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 8||0.11|-0.38|0.28
73854487|NCT04115748|147255732|SUPERIORITY||LS Mean Treatment Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.13||0.038|TWO_SIDED|95.0|-0.54|-0.02||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 12||-0.02|-0.54|0.038
73854488|NCT04115748|147255732|SUPERIORITY||LS Mean Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.129||0.25|TWO_SIDED|95.0|-0.41|0.11||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 12||0.11|-0.41|0.25
73854489|NCT04115748|147255732|SUPERIORITY||LS Mean Treatment Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.139||0.41|TWO_SIDED|95.0|-0.39|0.16||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||0.16|-0.39|0.41
73854490|NCT04115748|147255732|SUPERIORITY||LS Mean Treatment Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.138||0.26|TWO_SIDED|95.0|-0.43|0.12||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||0.12|-0.43|0.26
73854491|NCT04115748|147255733|SUPERIORITY||LS Mean Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|2.26||0.14|TWO_SIDED|95.0|-1.1|7.9||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||7.9|-1.1|0.14
73854492|NCT04115748|147255733|SUPERIORITY||LS Mean Treatment Difference|3.1|STANDARD_ERROR_OF_MEAN|2.3||0.18|TWO_SIDED|95.0|-1.5|7.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||7.7|-1.5|0.18
74024970|NCT01075087|147602549|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.5||||0.05|TWO_SIDED|90.0|-26.0|3.0|||Wilcoxon (Mann-Whitney)|||||3|-26|.05
74024971|NCT00283387|147602571|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
74024972|NCT00728416|147602582|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.31|||<|0.001|TWO_SIDED|95.0|-0.43|-0.19|||ANCOVA|||The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM PRIOR Nasal Congestion Score as covariates.||-0.19|-0.43|<0.001
74024973|NCT00728416|147602583|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.27|||<|0.001|TWO_SIDED|95.0|-1.72|-0.83|||ANCOVA|||The change from Baseline in average AM/PM PRIOR TNSS over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM TNSS as covariates.||-0.83|-1.72|<0.001
74024974|NCT00356915|147602591|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||P-Value from a Cochran-Mantel-Haenszel test, . The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.||||<0.001
74024975|NCT00356915|147602592|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. No p-value was calculated for this endpoint.|Wald's CI|0.56|||||ONE_SIDED|97.5|-4.3||||Wald's CI|The statistical analysis used Wald's CI with Yates' continuity correction.||Comparison between the 2 itraconazole groups was based on lower bound of the 97.5% confidence interval for the difference. The non-inferiority analysis was restricted to the active dosing groups.|||-4.3|
74024976|NCT00356915|147602593|NON_INFERIORITY_OR_EQUIVALENCE|The assumption was that the Complete Cure rate at week 52 was 35% for the active dosing groups, a sample size of 552 ITT subjects per active group would have had a 93% power for testing the proportion of subjects with Complete Cure. These computations assumed a non inferiority margin of 10% and a one-sided significance level of 0.025. Power computations were performed using nQuery Advisor, Version 5.0.|Mean Difference (Final Values)|10.0|||<|0.001|ONE_SIDED|97.5|-1.1||||Wald's CI|The statistical analysis used Wald's CI with Yates' continuity correction.||The test for demonstrating non-inferiority was based on a margin of 10%. Thus, non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. The non-inferiority analysis was restricted to the active dosing groups.|||-1.1|< 0.001
74024977|NCT00356915|147602594|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.||||<0.001
74024978|NCT00509106|147602595|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on the MITTE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for the MITTE populations.|Risk Difference (RD)|5.9|||||TWO_SIDED|95.0|-1.0|12.7|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared with that for ceftriaxone at TOC in the MITTE Population in adult subjects with CABP.||12.7|-1.0|
74024979|NCT00488631|147602608|SUPERIORITY_OR_OTHER|||||||0.01||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.010
74024980|NCT00488631|147602608|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.||||<0.001
73854493|NCT04115748|147255733|SUPERIORITY||LS Mean Treatment Difference|3.7|STANDARD_ERROR_OF_MEAN|2.53||0.15|TWO_SIDED|95.0|-1.4|8.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||8.7|-1.4|0.15
73854494|NCT04115748|147255733|SUPERIORITY||LS Mean Treatment Difference|4.8|STANDARD_ERROR_OF_MEAN|2.54||0.062|TWO_SIDED|95.0|-0.3|9.9||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||9.9|-0.3|0.062
73854495|NCT04115748|147255735|SUPERIORITY||LS Mean Treatment Difference|5.3|STANDARD_ERROR_OF_MEAN|1.68||0.003|TWO_SIDED|95.0|1.9|8.6||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||8.6|1.9|0.003
73854496|NCT04115748|147255735|SUPERIORITY||LS Mean Treatment Difference|4.9|STANDARD_ERROR_OF_MEAN|1.71||0.006|TWO_SIDED|95.0|1.5|8.3||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||8.3|1.5|0.006
73854497|NCT04115748|147255735|SUPERIORITY||LS Mean Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|2.09||0.076|TWO_SIDED|95.0|-0.4|8.0||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||8.0|-0.4|0.076
73854498|NCT04115748|147255735|SUPERIORITY||LS Mean Treatment Difference|3.5|STANDARD_ERROR_OF_MEAN|2.1||0.1|TWO_SIDED|95.0|-0.7|7.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||7.7|-0.7|0.10
73904333|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.0923|TWO_SIDED|95.0|-0.18|2.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.24|-0.18|0.0923
73904334|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.8482|TWO_SIDED|95.0|-1.11|1.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.35|-1.11|0.8482
73904335|NCT01227564|147338835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.284|TWO_SIDED|95.0|-0.49|1.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.64|-0.49|0.2840
73904336|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.1767|TWO_SIDED|95.0|-4.9|0.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.92|-4.90|0.1767
73904337|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26||||0.0057|TWO_SIDED|95.0|-7.23|-1.29||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||-1.29|-7.23|0.0057
73904338|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.13||||0.0176|TWO_SIDED|95.0|-5.69|-0.57||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||-0.57|-5.69|0.0176
73904339|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.679|TWO_SIDED|95.0|-3.98|2.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.61|-3.98|0.6790
73904340|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.9028|TWO_SIDED|95.0|-3.62|3.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||3.20|-3.62|0.9028
73930728|NCT03238911|147391299|SUPERIORITY||Mean Difference (Final Values)|-43.48|||<|0.0001|TWO_SIDED|95.0|-54.92|-32.03|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-32.03|-54.92|<0.0001
74024981|NCT00488631|147602609|SUPERIORITY_OR_OTHER|||||||0.122||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.122
74024982|NCT00488631|147602609|SUPERIORITY_OR_OTHER|||||||0.004||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.004
74024983|NCT00488631|147602610|SUPERIORITY_OR_OTHER|||||||0.011||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.011
74024984|NCT00488631|147602610|SUPERIORITY_OR_OTHER|||||||0.002||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.002
74024985|NCT00488631|147602611|SUPERIORITY_OR_OTHER|||||||0.365||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.||||0.365
74024986|NCT00488631|147602611|SUPERIORITY_OR_OTHER|||||||0.098||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.||||0.098
74024987|NCT00488631|147602612|SUPERIORITY_OR_OTHER|||||||0.279||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.279
74024988|NCT00488631|147602612|SUPERIORITY_OR_OTHER|||||||0.423||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.423
74024989|NCT02201940|147602621|SUPERIORITY_OR_OTHER||||||<|0.001||||||Participants in the SOF/VEL group were compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|Binomial test|||||||< 0.001
74024990|NCT03133767|147602781|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||||||0.608
74024991|NCT03133767|147602782|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
73854499|NCT01200407|147255746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-35.8||||0|TWO_SIDED|95.0|-37.2|-34.4|||t-test, 2 sided|||SBP with LOCF (Week 12)||-34.4|-37.2|0.000
73854500|NCT01200407|147255746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-19.4||||0|TWO_SIDED|95.0|-20.3|-18.6|||t-test, 2 sided|||DBP with LOCF (Week 12)||-18.6|-20.3|0.000
73854501|NCT01200407|147255747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-24.7||||0|TWO_SIDED|95.0|-26.1|-23.4|||t-test, 2 sided|||SBP w/o LOCF (Week 4)||-23.4|-26.1|0.000
73854502|NCT01200407|147255747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-33.0||||0|TWO_SIDED|95.0|-34.4|-31.6|||t-test, 2 sided|||SBP w/o LOCF (Week 8)||-31.6|-34.4|0.000
73854503|NCT01200407|147255747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-36.3||||0|TWO_SIDED|95.0|-37.9|-34.7|||t-test, 2 sided|||SBP w/o LOCF (Week 12)||-34.7|-37.9|0.000
74024992|NCT03133767|147602783|SUPERIORITY|||||||0.202|||||||Chi-squared|||||||0.202
74024993|NCT03133767|147602784|SUPERIORITY|||||||0.361|||||||Chi-squared|||||||0.361
73854504|NCT01200407|147255747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.2||||0|TWO_SIDED|95.0|-14.0|-12.4|||t-test, 2 sided|||DBP w/o LOCF (Week 4)||-12.4|-14.0|0.000
74024994|NCT03133767|147602785|SUPERIORITY|||||||0.509|||||||Chi-squared|||||||0.509
74024995|NCT00613626|147602794|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|22.718||0.1|ONE_SIDED|90.0|||||Log Rank|||A one-sided log rank test with an overall sample size of 68 subjects (of which 34 are in arm A and 34 are in arm B) achieves 80% power at a 0.10 significance level to detect a difference of 3 months in PFS between 4 month median PFS and 7 month median PFS.||||0.10
74024996|NCT00613626|147602794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9518|TWO_SIDED|||||P-Value (2-tailed) is calculated based on the unstratified log-rank test.|Log Rank|Degrees of freedom=1||||||0.9518
73854505|NCT01200407|147255747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-17.6||||0|TWO_SIDED|95.0|-18.4|-16.7|||t-test, 2 sided|||DBP w/o LOCF (Week 8)||-16.7|-18.4|0.000
73854506|NCT01200407|147255747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-19.9||||0|TWO_SIDED|95.0|-20.8|-18.9|||t-test, 2 sided|||DBP w/o LOCF (Week 12)||-18.9|-20.8|0.000
74024997|NCT00613626|147602796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2533|TWO_SIDED||||||Difference in Rates|P-value (two-tailed) is calculated based on an unadjusted, normal-distribution approximation for the difference in rates.||||||0.2533
74024998|NCT00613626|147602797|SUPERIORITY_OR_OTHER_LEGACY|||||||0.872|TWO_SIDED||||||Difference in Rates|||||||0.8720
74024999|NCT00613626|147602798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4577|TWO_SIDED||||||Log Rank|||||||0.4577
74025000|NCT00613626|147602799|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.05|||||TWO_SIDED|95.0|||||||Survival analysis of VEGF variants using cox proportional hazard analysis in arm A and arm B.|Data was not collected for safety lead-in participants and these participants were not included in the analysis.||||
73904341|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.45||||0.76|TWO_SIDED|95.0|-3.36|2.47||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.47|-3.36|0.7600
73904342|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.4089|TWO_SIDED|95.0|-4.51|1.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.86|-4.51|0.4089
73904343|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17||||0.1964|TWO_SIDED|95.0|-5.49|1.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.15|-5.49|0.1964
73904344|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.2234|TWO_SIDED|95.0|-4.58|1.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.09|-4.58|0.2234
73904345|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.6186|TWO_SIDED|95.0|-3.52|2.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.12|-3.52|0.6186
73904346|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.5853|TWO_SIDED|95.0|-3.6|2.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.06|-3.60|0.5853
73930729|NCT03238911|147391299|SUPERIORITY||Mean Difference (Final Values)|-1.68||||0.373|TWO_SIDED|95.0|-5.41|2.04|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.04|-5.41|0.3730
74025001|NCT00613626|147602799|SUPERIORITY_OR_OTHER_LEGACY||Logistic Regression Analysis|0.05|||||TWO_SIDED|95.0|||||||Objective Response Analysis of VEGF variants using Logistic Regression Analysis in arm A and arm B|||||
74025002|NCT02333227|147602800|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis||||We employed generalized linear mixed methods (GLMM) with binomial distribution to examine the association between study primary outcomes of baby's birth weight (\<2500) and gestational age at delivery (\<37 weeks including up to 36 and 6/7 weeks) and assignment to the study intervention group. To account for clustering of outcomes by cluster (sites), we used random slope/random intercept GLMM models with a cluster as a random effect (level 2) and treatment as a fixed effect (level 1), since random effect modeling is an individual-level analyses that accounts for within-cluster dependence by maximum likelihood estimation. A separate model was fit to each study outcome and corresponding relative risk with 95% confidence intervals (CI) estimated. Full information maximum likelihood estimation (FIML) allows for analyses to be performed with the full sample, under conditions of Missing Completely at Random (MCAR) and Missing at Random (MAR), and with missing data rates up to 50%.|||<0.05
74088305|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.09||0.0093|TWO_SIDED|95.0|0.56|0.92|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.92|0.56|0.0093
73904347|NCT01227564|147338836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.5541|TWO_SIDED|95.0|-3.23|1.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.75|-3.23|0.5541
73904348|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.937|TWO_SIDED|95.0|-2.09|1.93||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.93|-2.09|0.9370
73904349|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.2597|TWO_SIDED|95.0|-3.19|0.88||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.88|-3.19|0.2597
73904350|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.4852|TWO_SIDED|95.0|-2.38|1.14||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.14|-2.38|0.4852
73904351|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.4542|TWO_SIDED|95.0|-2.69|1.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.22|-2.69|0.4542
73904352|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.3061|TWO_SIDED|95.0|-3.04|0.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.97|-3.04|0.3061
73930730|NCT03238911|147391299|SUPERIORITY||Mean Difference (Final Values)|-1.63||||0.4778|TWO_SIDED|95.0|-6.15|2.9|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.90|-6.15|0.4778
73930731|NCT03238911|147391299|SUPERIORITY||Mean Difference (Final Values)|-1.73||||0.3575|TWO_SIDED|95.0|-5.44|1.98|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.98|-5.44|0.3575
74025003|NCT02333227|147602801|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Co-primary outcomes|We employed generalized linear mixed methods (GLMM) with binomial distribution to examine the association between study primary outcomes of baby's birth weight (\<2500) and gestational age at delivery (\<37 weeks including up to 36 and 6/7 weeks) and assignment to the study intervention group. To account for clustering of outcomes by cluster (sites), we used random slope/random intercept GLMM models with a cluster as a random effect (level 2) and treatment as a fixed effect (level 1), since random effect modeling is an individual-level analyses that accounts for within-cluster dependence by maximum likelihood estimation. A separate model was fit to each study outcome and corresponding relative risk with 95% confidence intervals (CI) estimated. Full information maximum likelihood estimation (FIML) allows for analyses to be performed with the full sample, under conditions of Missing Completely at Random (MCAR) and Missing at Random (MAR), and with missing data rates up to 50%.|||<0.05
74025004|NCT02333227|147602802|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73930732|NCT03238911|147391300|SUPERIORITY||Risk Difference (RD)|-11.9||||0.005|TWO_SIDED|95.0|-20.1|-3.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.||-3.6|-20.1|0.0050
73930733|NCT02239536|147391301|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
73854507|NCT01450696|147255751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.2401|TWO_SIDED|95.0|0.86|1.78|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 milliliters per minute \[mL/min\] and greater than or equal to \[≥\] 60 mL/min). Hazard ratio was estimated by Cox regression.||1.78|0.86|0.2401
73904353|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.88||||0.3082|TWO_SIDED|95.0|-2.61|0.84||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.84|-2.61|0.3082
73854508|NCT01450696|147255751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.1285|TWO_SIDED|95.0|0.92|1.88|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||1.88|0.92|0.1285
73854509|NCT01450696|147255753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9931|TWO_SIDED|95.0|0.49|2.04|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.||2.04|0.49|0.9931
73854510|NCT01450696|147255753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9458|TWO_SIDED|95.0|0.52|2.02|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||2.02|0.52|0.9458
73854511|NCT01450696|147255755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.6759|TWO_SIDED|95.0|0.63|2.02|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.||2.02|0.63|0.6759
73854512|NCT01450696|147255755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.5764|TWO_SIDED|95.0|0.67|2.05|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||2.05|0.67|0.5764
73854513|NCT01450696|147255756|SUPERIORITY_OR_OTHER||Difference in response rates|-7.58||||0.5402|TWO_SIDED|95.0|-31.75|16.6|||Chi-squared|||The 95% CI for difference in response rates was constructed using the normal approximation to the binomial distribution.||16.60|-31.75|0.5402
73854514|NCT01450696|147255756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.28|1.96||||||||1.96|0.28|
73854515|NCT01843673|147255759|NON_INFERIORITY_OR_EQUIVALENCE|Statistical significance testing at 5% level of significance, p-value being larger than 0.05 . The p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and CBCT was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.||||1.00
73904354|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.2672|TWO_SIDED|95.0|-3.09|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.87|-3.09|0.2672
73904355|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.11||||0.0427|TWO_SIDED|95.0|-4.15|-0.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||-0.07|-4.15|0.0427
73854516|NCT01843673|147255759|NON_INFERIORITY_OR_EQUIVALENCE|Statistical significance testing at 5% level of significance, p-value being larger than 0.05. Those are the p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and ExacTrac was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.||||1.00
73854517|NCT01257230|147255772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.051||0.0085|TWO_SIDED|95.0|0.034|0.234|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.234|0.034|0.0085
73854518|NCT01257230|147255772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.05||0.0005|TWO_SIDED|95.0|0.076|0.272|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.272|0.076|0.0005
73930734|NCT02239536|147391302|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
73930735|NCT02239536|147391302|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
73930736|NCT02665481|147391338|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.5|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.07|-0.15|0.50
73930737|NCT02665481|147391338|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.18|TWO_SIDED|95.0|-0.04|0.19|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||0.19|-0.04|0.18
73930738|NCT02665481|147391338|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.23|TWO_SIDED|95.0|-0.04|0.17|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||0.17|-0.04|0.23
73930739|NCT02665481|147391338|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.47|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x Exercise (Month 0 and Month 18)||0.07|-0.15|0.47
73930740|NCT02665481|147391339|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.12|TWO_SIDED|95.0|-0.02|0.19|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.19|-0.02|0.12
74025005|NCT02333227|147602803|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis||||Specifically, the composite of periodontal disease was also created; this composite was positive if any of the following were detected: gingival bleeding, pockets of 4 mm or greater, or loss of attachment of 4 mm or greater. A scaled periodontal disease score was also created which was the sum of scores for gingival bleeding (+1 if bleeding was present, per tooth), gingival pockets (+1 for pockets of 4-5 mm and +2 for 6 mm or deeper, per tooth), and loss of attachment (+1 for 4-5 mm loss, +2 for 6-8 mm, +3 for 9-11 mm, and +4 for 12 mm or more, per tooth with values recorded for index teeth) divided by the number of teeth present.|||<0.05
74025006|NCT02333227|147602804|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74025007|NCT01299025|147602805|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74088306|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.09||0.0237|TWO_SIDED|95.0|0.59|0.96|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.96|0.59|0.0237
73854519|NCT01257230|147255773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.056||0.1307|TWO_SIDED|95.0|-0.025|0.194|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.194|-0.025|0.1307
73854520|NCT01257230|147255773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.054||0.032|TWO_SIDED|95.0|0.01|0.223|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.223|0.010|0.0320
73854521|NCT01257230|147255774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.057||0.1231|TWO_SIDED|95.0|-0.024|0.2|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.200|-0.024|0.1231
73854522|NCT01257230|147255774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.056||0.195|TWO_SIDED|95.0|-0.037|0.182|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.182|-0.037|0.1950
73854523|NCT01257230|147255775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.06||0.2921|TWO_SIDED|95.0|-0.055|0.181|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.181|-0.055|0.2921
73854524|NCT01257230|147255775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.059||0.5495|TWO_SIDED|95.0|-0.08|0.15|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.150|-0.080|0.5495
73854525|NCT01257230|147255776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.049||0.0079|TWO_SIDED|95.0|0.034|0.225|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.225|0.034|0.0079
73854526|NCT01257230|147255776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.048||0.0002|TWO_SIDED|95.0|0.088|0.275|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.275|0.088|0.0002
73854527|NCT01257230|147255777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.054||0.0945|TWO_SIDED|95.0|-0.016|0.196|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.196|-0.016|0.0945
73854528|NCT01257230|147255777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.053||0.1755|TWO_SIDED|95.0|-0.032|0.175|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.175|-0.032|0.1755
73854529|NCT01257230|147255779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.092||0.976|TWO_SIDED|95.0|-0.184|0.178|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.178|-0.184|0.9760
73854530|NCT01257230|147255779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.09||0.9224|TWO_SIDED|95.0|-0.186|0.168|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.168|-0.186|0.9224
74025008|NCT01624194|147602809|OTHER|||||||0.0275|||||||General Linear Model (GLM)|||||||0.0275
74088307|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.11||0.0374|TWO_SIDED|95.0|0.56|0.98|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.98|0.56|0.0374
73854531|NCT01257230|147255780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.083||0.7852|TWO_SIDED|95.0|-0.14|0.185|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.185|-0.140|0.7852
73854532|NCT01257230|147255780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.081||0.1649|TWO_SIDED|95.0|-0.046|0.271|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.271|-0.046|0.1649
73854533|NCT01257230|147255781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.143||0.8253|TWO_SIDED|95.0|-0.312|0.249|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.249|-0.312|0.8253
73854534|NCT01257230|147255781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.14||0.7559|TWO_SIDED|95.0|-0.232|0.319|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.319|-0.232|0.7559
73854535|NCT01257230|147255782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.087||0.0653|TWO_SIDED|95.0|-0.33|0.01|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.010|-0.330|0.0653
73854536|NCT01257230|147255782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.084||0.2516|TWO_SIDED|95.0|-0.263|0.069|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.069|-0.263|0.2516
73854537|NCT01257230|147255784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.095||0.12|TWO_SIDED|95.0|-0.333|0.038|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.038|-0.333|0.1200
73854538|NCT01257230|147255784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.092||0.5589|TWO_SIDED|95.0|-0.235|0.127|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.127|-0.235|0.5589
74025009|NCT01624194|147602810|OTHER||||||>|0.05||||||Fisher's Exact Test was used to test for differences in adverse events between oxytocin-treated and placebo-treated individuals. A p-value of ≤0.05 would have been statistically significant.|Fisher Exact|||||||>0.05
74025010|NCT01624194|147602811|OTHER||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.||||||>0.05
74025011|NCT01624194|147602814|OTHER|||||||0.3395|||||||General Linear Model (GLM)|||||||0.3395
74025012|NCT01624194|147602822|OTHER|||||||0.9757|||||||General Linear Model (GLM)|||||||0.9757
74025013|NCT01624194|147602823|OTHER||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.||||||>0.05
74025014|NCT01624194|147602824|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
74025015|NCT01624194|147602825|OTHER||||||>|0.05||||||For all blood pressure analyses.|Mixed Models Analysis|||||||>0.05
74025016|NCT05480514|147602846|SUPERIORITY|A superiority margin of 0.90 was used. Superiority was concluded if the lower bound of the 95% central posterior credible interval was above 0.90.|Mean Posterior Proportion|0.9741|STANDARD_DEVIATION|0.01244|||TWO_SIDED|95.0|0.9445|0.9926|||Bayesian beta-binomial model|||||0.9926|0.9445|
74025017|NCT05662332|147602853|NON_INFERIORITY|Noninferiority margin (NIM) was 0.4%|LS Mean Change difference|-0.03|||||TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|
74025018|NCT05662332|147602854|SUPERIORITY||LS Mean Change difference|-0.03||||0.684|TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|0.684
74025019|NCT05662332|147602855|SUPERIORITY||LS Mean Change difference|4.16||||0.155|TWO_SIDED|95.0|-1.58|9.9|||ANCOVA|||Week 52||9.90|-1.58|0.155
74025020|NCT05662332|147602856|SUPERIORITY||LS Mean Change difference|-43.7|||<|0.001|TWO_SIDED|95.0|-62.4|-25.0|||Mixed Models Analysis|||Week 52||-25.0|-62.4|<0.001
74025021|NCT05662332|147602857|SUPERIORITY||Relative Rate|0.57||||0.005|TWO_SIDED|95.0|0.39|0.84|||Negative binomial model|||||0.84|0.39|0.005
73854539|NCT01257230|147255786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.4023|TWO_SIDED|95.0|0.21|1.87|||Regression, Cox|||||1.87|0.21|0.4023
73854540|NCT01257230|147255786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.23||||0.062|TWO_SIDED|95.0|0.05|1.08|||Regression, Cox|||||1.08|0.05|0.0620
73854541|NCT01257230|147255787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.87|TWO_SIDED|95.0|0.65|1.66|||Regression, Cox|||||1.66|0.65|0.8700
73854542|NCT01257230|147255787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.4198|TWO_SIDED|95.0|0.51|1.33|||Regression, Cox|||||1.33|0.51|0.4198
74025022|NCT05662332|147602859|SUPERIORITY||Relative Rate|0.58||||0.155|TWO_SIDED|95.0|0.28|1.23|||Negative binomial model|||||1.23|0.28|0.155
74088308|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.11||0.0468|TWO_SIDED|95.0|0.57|1.0|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.00|0.57|0.0468
74025023|NCT05662332|147602861|SUPERIORITY||LS Mean difference (Final Values)|0.57||||0.033|TWO_SIDED|95.0|0.047|1.1|||Mixed Models Analysis|||||1.10|0.047|0.033
74025024|NCT05662332|147602862|SUPERIORITY||LS Mean difference (Final Values)|1.56||||0.071|TWO_SIDED|95.0|-0.13|3.25|||Mixed Models Analysis|||Week 52||3.25|-0.13|0.071
74088309|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.11||0.0751|TWO_SIDED|95.0|0.59|1.03|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.03|0.59|0.0751
73854543|NCT03070171|147255809|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-tz of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.46909|||||TWO_SIDED|90.0|101.44605|115.97833|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.97833|101.44605|
73930741|NCT02665481|147391339|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.44|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||0.07|-0.15|0.44
74025025|NCT05662332|147602865|SUPERIORITY||LS Mean difference (Final Values)|1.8||||0.072|TWO_SIDED|95.0|-0.2|3.8|||Mixed Models Analysis|||Week 52||3.8|-0.2|0.072
74025026|NCT04885257|147602867|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
74025027|NCT00803114|147602877|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22||||0.05||95.0|0.12|0.41|||Fisher Exact||Relative risk describes the risk of requiring additional analgesics in the first 24 hours postpartum with the denominator being the arm which received placebo.|Relative risk ratio estimation with 95% CI using exact methods||0.41|0.12|0.05
74025028|NCT00803114|147602878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|0.8||0.05||95.0|-5.7|-2.3|||t-test, 2 sided|degrees of freedom 226|The epidural morphine group represents the baseline of comparison for difference in means, with the placebo group requiring additional analgesics earlier.|||-2.3|-5.7|0.05
74025029|NCT00803114|147602879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.3||0.05||95.0|0.7|1.8|||t-test, 2 sided|degrees of freedom 212|Difference in VAS score when compared to the baseline group, subjects receiving epidural morphine|||1.8|0.7|0.05
74025030|NCT00803114|147602880|SUPERIORITY_OR_OTHER|||||||0.8||||||Fisher's exact test result did not reveal statistically significant differences between expected and real frequencies in any of the categories.|Fisher Exact|||||||0.80
74025031|NCT01672892|147602898|SUPERIORITY|||||||0.0476|||||||t-test, 1 sided|||Since there is no prior data using this tool in this patient population, an effect size of 0.4 was chosen to calculate sample size. Based on a two-sample t-test with one interim look and a two-sided alpha=0.05, a sample size of 225 is needed to achieve 85% statistical power. Assuming an attrition rate of 10% and noncompliance of 10%, 281 patients were required in order to ensure 225 evaluable patients for the primary endpoint analysis.||||0.0476
74025032|NCT01672892|147602899|SUPERIORITY|||||||0.4338|||||||Binomial test of proportions|2-sided significance level = 0.05||||||0.4338
74025033|NCT01672892|147602900|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 3 of RT||||0.04
74025034|NCT01672892|147602900|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 5 of RT||||0.03
74025035|NCT01672892|147602900|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|2-sided significance level of 0.05||4-6 weeks post-RT||||0.41
74025036|NCT01672892|147602901|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-G total score - 5 weeks||||0.54
74025037|NCT01672892|147602901|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|FACT-G total score - 4-6 weeks post RT||FACT-G total score - 4-6 weeks post RT||||0.72
73854544|NCT03070171|147255810|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.9587|||||TWO_SIDED|90.0|101.78627|116.63654|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||116.63654|101.78627|
73904356|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.0716|TWO_SIDED|95.0|-3.37|0.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.15|-3.37|0.0716
73904357|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.7184|TWO_SIDED|95.0|-2.09|3.0||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.00|-2.09|0.7184
73904358|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.7004|TWO_SIDED|95.0|-2.06|3.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.03|-2.06|0.7004
74088310|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.81|STANDARD_ERROR_OF_MEAN|0.11||0.1305|TWO_SIDED|95.0|0.61|1.06|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.06|0.61|0.1305
73854545|NCT03070171|147255811|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.61507|||||TWO_SIDED|90.0|100.61938|115.09714|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.09714|100.61938|
73854546|NCT03070171|147255812|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|106.69566|||||TWO_SIDED|90.0|99.50139|114.4101|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||114.41010|99.50139|
73854547|NCT03070171|147255813|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.83324|||||TWO_SIDED|90.0|101.25584|114.8379|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||114.83790|101.25584|
73930742|NCT02665481|147391339|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.17|TWO_SIDED|95.0|-0.03|0.18|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||0.18|-0.03|0.17
73930743|NCT02665481|147391339|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.93|TWO_SIDED|95.0|-0.12|0.11|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.11|-0.12|0.93
73930744|NCT02665481|147391340|SUPERIORITY||Mean Difference (Final Values)|-3.46||||0.53|TWO_SIDED|95.0|-14.27|7.34|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||7.34|-14.27|0.53
73930745|NCT02665481|147391340|SUPERIORITY||Mean Difference (Final Values)|-20.16||||0.004|TWO_SIDED|95.0|-33.88|-6.44|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||-6.44|-33.88|0.004
73930746|NCT02665481|147391340|SUPERIORITY||Mean Difference (Final Values)|3.04||||0.58|TWO_SIDED|95.0|-7.76|13.85|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||13.85|-7.76|0.58
73930747|NCT02665481|147391340|SUPERIORITY||Mean Difference (Final Values)|-6.26||||0.37|TWO_SIDED|95.0|-19.98|7.46|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||7.46|-19.98|0.37
73930748|NCT02665481|147391341|SUPERIORITY||Mean Difference (Final Values)|22.71||||0.33|TWO_SIDED|95.0|-22.95|68.36|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||68.36|-22.95|0.33
73930749|NCT02665481|147391341|SUPERIORITY||Mean Difference (Final Values)|25.35||||0.31|TWO_SIDED|95.0|-23.18|73.88|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||73.88|-23.18|0.31
73930750|NCT02665481|147391341|SUPERIORITY||Mean Difference (Final Values)|-17.18||||0.46|TWO_SIDED|95.0|-62.83|28.48|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||28.48|-62.83|0.46
73930751|NCT02665481|147391341|SUPERIORITY||Mean Difference (Final Values)|21.11||||0.39|TWO_SIDED|95.0|-27.41|69.64|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||69.64|-27.41|0.39
73930752|NCT02665481|147391342|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.37|TWO_SIDED|95.0|-0.02|0.01|||Marginal Model|||Time x MBSR (Month 0 and Month 6).||0.01|-0.02|0.37
73930753|NCT02665481|147391342|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.1|TWO_SIDED|95.0|-0.02|0.0|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||0.00|-0.02|0.10
73904359|NCT01227564|147338837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.6723|TWO_SIDED|95.0|-1.77|2.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.71|-1.77|0.6723
74025038|NCT01672892|147602901|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 5 weeks||||0.01
74025039|NCT01672892|147602901|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 4-6 weeks post RT||||0.45
74025040|NCT01672892|147602901|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 5 weeks||||0.03
74025041|NCT01672892|147602901|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 4-6 weeks post RT||||0.9
74025042|NCT01672892|147602901|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 5 weeks||||0.55
74025043|NCT01672892|147602901|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 4-6 weeks post RT||||0.35
74025044|NCT01672892|147602901|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 5 weeks||||0.66
74025045|NCT01672892|147602901|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 4-6 weeks post RT||||0.09
73930754|NCT02665481|147391342|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.21|TWO_SIDED|95.0|-0.004|0.02|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.02|-0.004|0.21
73930755|NCT02665481|147391342|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.09|TWO_SIDED|95.0|-0.02|0.0|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.00|-0.02|0.09
73930756|NCT02665481|147391343|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.57|TWO_SIDED|95.0|-0.38|0.69|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.69|-0.38|0.57
73930757|NCT02665481|147391343|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.96|TWO_SIDED|95.0|-0.58|0.55|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||0.55|-0.58|0.96
73930758|NCT02665481|147391343|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.37|TWO_SIDED|95.0|-0.78|0.29|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.29|-0.78|0.37
73930759|NCT02665481|147391343|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.99|TWO_SIDED|95.0|-0.57|0.57|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.57|-0.57|0.99
73930760|NCT02665481|147391344|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.19|TWO_SIDED|95.0|-0.47|2.33|||Marginal Model|||Time x MBSR (Month 0 and Month 6).||2.33|-0.47|0.19
73930761|NCT02665481|147391344|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.09|TWO_SIDED|95.0|-0.19|2.77|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||2.77|-0.19|0.09
73930762|NCT02665481|147391344|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.42|TWO_SIDED|95.0|-1.97|0.83|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.83|-1.97|0.42
73930763|NCT02665481|147391344|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.54|TWO_SIDED|95.0|-1.01|1.94|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||1.94|-1.01|0.54
73930764|NCT00436280|147391391|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.512|||||TWO_SIDED|95.0|0.217|1.206|||||Comparing GCB versus non-GCB|Comparing GCB versus non-GCB||1.206|0.217|
73930765|NCT00436280|147391392|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878|||||TWO_SIDED|95.0|0.388|1.989|||||Comparing High Expression versus Low Expression|Comparing High Expression versus Low Expression||1.989|0.388|
73930766|NCT01663259|147391405|OTHER||||||||||||||||||Estimates of proportion event-free at 1 and 2 years calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals were calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
73930767|NCT01663259|147391406|OTHER||||||||||||||||||Survival proportion estimates at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
73930768|NCT01663259|147391407|OTHER||||||||||||||||||Estimates of proportion LRP event-free at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
73930769|NCT01049919|147391408|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.224|TWO_SIDED|95.0|0.31|1.31|||Proportional Hazards Regression|||||1.31|0.31|0.224
73930770|NCT01049919|147391409|SUPERIORITY|||||||0.671||||||Treatment-by-week p-value is reported.|Repeated measures model|The statistical analysis model includes treatment group, week, treatment-by-week, and baseline pain measurement.||||||0.671
73930771|NCT01049919|147391410|SUPERIORITY|||||||0.714||||||Treatment-by-week p-value is reported.|Repeated measures model|The statistical analysis model includes treatment group, week, treatment-by-week, and baseline pain measurement.||||||0.714
73930772|NCT01049919|147391412|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.018|TWO_SIDED|95.0|0.16|0.85|||Proportional Hazards Regression|||||0.85|0.16|0.018
73930773|NCT02566759|147391425|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.6662|||||TWO_SIDED|90.0|0.5969|0.7355||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) is equal to (=) a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 percent (%) confidence interval (CI) of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.7355|0.5969|
73930774|NCT02566759|147391425|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.7795|||||TWO_SIDED|90.0|0.6597|0.8993|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||0.8993|0.6597|
73930775|NCT02566759|147391425|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Ratio|0.362|||||TWO_SIDED|90.0|0.3043|0.4301||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed lease square (LS) Means.||0.4301|0.3043|
74025046|NCT01672892|147602901|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 5 weeks||||0.66
74025047|NCT01672892|147602901|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 4-6 weeks post RT||||0.35
74025048|NCT01672892|147602902|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|2-sided significance level = 0.05||5 weeks||||0.61
74025049|NCT01672892|147602902|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|2-sided significance level = 0.05||4-6 weeks post-RT||||0.67
74025050|NCT01672892|147602903|SUPERIORITY|||||||0.81|||||||Gray's test|Two-sided significance level = 0.05||||||0.81
74025051|NCT01672892|147602904|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.21|TWO_SIDED|95.0|0.82|2.35|||Log Rank|Two-side significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy|||2.35|0.82|0.21
74025052|NCT01672892|147602905|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.53|TWO_SIDED|95.0|0.32|1.79|||Log Rank|Two-sided significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy|||1.79|0.32|0.53
73854548|NCT03070171|147255814|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.43158|||||TWO_SIDED|90.0|101.87254|115.41292|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.41292|101.87254|
73854549|NCT01471028|147255817|SUPERIORITY||Hazard Ratio (HR)|1.027||||0.904|TWO_SIDED|95.0|0.689|1.53|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.||1.53|0.689|0.904
73854550|NCT01471028|147255818|SUPERIORITY|||||||0.737|||||||Chi-squared|||||||0.737
74025053|NCT01672892|147602908|OTHER||||||<|0.0001|||||||nonparametric one-sample t-test|||Baseline||||<0.0001
74025054|NCT01672892|147602908|OTHER||||||<|0.0001|||||||nonparametric one-sample t-test|||Week 5||||<0.0001
74025055|NCT01672892|147602909|OTHER||||||<|0.0001|||||||One-sample t-test|||Bowel domain at baseline||||<0.0001
74025056|NCT01672892|147602909|OTHER||||||<|0.0001|||||||One-sample t-test|||Bowel domain at week 5||||<0.0001
74025057|NCT01672892|147602909|OTHER||||||<|0.0001|||||||One-sample t-test|||Urinary domain at baseline||||<0.0001
74025058|NCT01672892|147602909|OTHER||||||<|0.0001|||||||One-sample t-test|||Urinary domain at week 5||||<0.0001
73854551|NCT01471028|147255819|SUPERIORITY||Hazard Ratio (HR)|1.315||||0.168|TWO_SIDED|95.0|0.886|1.952|||Log Rank|||||1.952|0.886|0.168
73854552|NCT01471028|147255820|SUPERIORITY||Hazard Ratio (HR)|0.283||||0.007|TWO_SIDED|95.0|0.109|0.732|||Log Rank|||||0.732|0.109|0.007
73854553|NCT01626118|147255835|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|317.612|STANDARD_ERROR_OF_MEAN|149.6694||0.034|TWO_SIDED|95.0|23.297|611.926|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||611.926|23.297|0.034
74025059|NCT01672892|147602910|OTHER||||||<|0.0001|||||||Paired t-test|||Bowel domain||||<0.0001
74025060|NCT01672892|147602910|OTHER||||||<|0.0001|||||||Paired t-test|||Urinary domain||||<0.0001
74025061|NCT02424539|147602979|OTHER||Mean Difference (Final Values)|-1.23|||<|0.001|TWO_SIDED|95.0|-1.68|-0.78|||ANCOVA||Least square (LS) mean difference between placebo and FF 55 µg QD has been presented using analysis of co-variance (ANCOVA) model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.78|-1.68|<0.001
74025062|NCT02424539|147602979|OTHER||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-1.77|-0.87|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.87|-1.77|<0.001
74025063|NCT02424539|147602980|OTHER||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.14|0.39|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.39|0.14|<0.001
74025064|NCT02424539|147602980|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.33|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.33|0.12|<0.001
74025065|NCT02424539|147602981|OTHER||Mean Difference (Final Values)|-2.15|||<|0.001|TWO_SIDED|95.0|-2.84|-1.46|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.46|-2.84|<0.001
74025066|NCT02424539|147602981|OTHER||Mean Difference (Final Values)|-1.98|||<|0.001|TWO_SIDED|95.0|-2.66|-1.29|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.29|-2.66|<0.001
74025067|NCT02424539|147602982|OTHER||Mean Difference (Final Values)|-0.1||||0.503|TWO_SIDED|95.0|-0.38|0.18|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.18|-0.38|0.503
74025068|NCT02424539|147602982|OTHER||Mean Difference (Final Values)|-0.25||||0.078|TWO_SIDED|95.0|-0.53|0.03|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.03|-0.53|0.078
74025069|NCT02424539|147602983|OTHER||Mean Difference (Final Values)|0.51||||0.048|TWO_SIDED|95.0|0.01|1.02|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||1.02|0.01|0.048
74025070|NCT02424539|147602983|OTHER||Mean Difference (Final Values)|0.66||||0.011|TWO_SIDED|95.0|0.16|1.17|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||1.17|0.16|0.011
73854554|NCT01626118|147255835|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|342.132|STANDARD_ERROR_OF_MEAN|150.0397||0.023|TWO_SIDED|95.0|47.09|637.175|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||637.175|47.090|0.023
73854555|NCT01626118|147255835|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|61.972|STANDARD_ERROR_OF_MEAN|150.2717||0.68|TWO_SIDED|95.0|-233.527|357.471|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||357.471|-233.527|0.680
73854556|NCT01626118|147255835|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|503.008|STANDARD_ERROR_OF_MEAN|102.3149|<|0.001|TWO_SIDED|95.0|301.93|704.086|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||704.086|301.930|<0.001
73854557|NCT01626118|147255835|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|511.357|STANDARD_ERROR_OF_MEAN|102.5851|<|0.001|TWO_SIDED|95.0|309.749|712.965|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||712.965|309.749|<0.001
73854558|NCT01626118|147255835|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|341.232|STANDARD_ERROR_OF_MEAN|102.7761|<|0.001|TWO_SIDED|95.0|139.249|543.215|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||543.215|139.249|<0.001
73854559|NCT01626118|147255836|SUPERIORITY_OR_OTHER|||||||0.191|||||||t-test, 2 sided|||||||0.191
73854560|NCT01626118|147255836|SUPERIORITY_OR_OTHER|||||||0.108|||||||t-test, 2 sided|||||||0.108
73854561|NCT01626118|147255836|SUPERIORITY_OR_OTHER|||||||0.461|||||||t-test, 2 sided|||||||0.461
73854562|NCT01626118|147255837|SUPERIORITY_OR_OTHER|||||||0.079|||||||t-test, 2 sided|||||||0.079
73904360|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9535|TWO_SIDED|95.0|-1.58|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.68|-1.58|0.9535
73930776|NCT02566759|147391425|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|1.799|||||TWO_SIDED|90.0|1.4625|2.2116||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||2.2116|1.4625|
73854563|NCT01626118|147255837|SUPERIORITY_OR_OTHER|||||||0.041|||||||t-test, 2 sided|||||||0.041
73854564|NCT01626118|147255837|SUPERIORITY_OR_OTHER|||||||0.458|||||||t-test, 2 sided|||||||0.458
73854565|NCT01626118|147255838|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.020
73854566|NCT01626118|147255838|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||||||0.021
73854567|NCT01626118|147255838|SUPERIORITY_OR_OTHER|||||||0.441|||||||t-test, 2 sided|||||||0.441
73854568|NCT01626118|147255839|SUPERIORITY_OR_OTHER|||||||0.141|||||||t-test, 2 sided|||||||0.141
73854569|NCT01626118|147255839|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
73854570|NCT01626118|147255839|SUPERIORITY_OR_OTHER|||||||0.716|||||||t-test, 2 sided|||||||0.716
73854571|NCT01626118|147255840|SUPERIORITY_OR_OTHER|||||||0.049|||||||t-test, 2 sided|||||||0.049
73854572|NCT01626118|147255840|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.020
73854573|NCT01626118|147255840|SUPERIORITY_OR_OTHER|||||||0.593|||||||t-test, 2 sided|||||||0.593
73854574|NCT01626118|147255841|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||||||0.021
73854575|NCT01626118|147255841|SUPERIORITY_OR_OTHER|||||||0.012|||||||t-test, 2 sided|||||||0.012
73854576|NCT01626118|147255841|SUPERIORITY_OR_OTHER|||||||0.447|||||||t-test, 2 sided|||||||0.447
73854577|NCT01626118|147255842|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
73854578|NCT01626118|147255842|SUPERIORITY_OR_OTHER|||||||0.017|||||||t-test, 2 sided|||||||0.017
73854579|NCT01626118|147255842|SUPERIORITY_OR_OTHER|||||||0.577|||||||t-test, 2 sided|||||||0.577
73854580|NCT00683930|147255876|SUPERIORITY_OR_OTHER||Treatment difference in response rate|5.1||||0.6558||97.5|-17.4|27.6|||Fisher Exact|Alpha = 0.025||||27.6|-17.4|0.6558
73854581|NCT01208961|147255947|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|400.36|||<|0.001|TWO_SIDED|90.0|326.87|490.36|||ANOVA|ANOVA on log-trans baseline-adj PK values using sequence, period, and treatments as fixed effects and subject nested within sequence as random effect||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||490.36|326.87|<0.001
73854582|NCT01208961|147255948|SUPERIORITY_OR_OTHER||Ratio of Geometric Mans|649.66|||<|0.01|TWO_SIDED|90.0|511.75|824.75||ANOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors. LSM estimate performed on log-scale|ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||824.75|511.75|<0.01
73962552|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|2.64|STANDARD_ERROR_OF_MEAN|1.72||0.1261|TWO_SIDED|95.0|-0.75|6.04|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||6.04|-0.75|0.1261
73854583|NCT01208961|147255949|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|369.66|||<|0.001|TWO_SIDED|90.0|301.74|452.86|||ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||452.86|301.74|<0.001
73854584|NCT02152371|147255953|SUPERIORITY_OR_OTHER_LEGACY||LS Means Diff|-0.77|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.97|-0.56|||Mixed Model for Repeated Measures (MMRM)|||||-0.56|-0.97|<.001
73854585|NCT02152371|147255954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-16.73|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-26.02|-7.44|||Mixed Models Analysis|||||-7.44|-26.02|<.001
73854586|NCT02152371|147255955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-8.06|STANDARD_ERROR_OF_MEAN|2.95||0.007|TWO_SIDED|95.0|-13.87|-2.25|||Mixed Models Analysis|||Pre-Morning Meal||-2.25|-13.87|.007
73854587|NCT02152371|147255955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-17.18|STANDARD_ERROR_OF_MEAN|4.45|<|0.001|TWO_SIDED|95.0|-25.96|-8.4|||Mixed Models Analysis|||Morning Meal 2-Hour Postprandial||-8.40|-25.96|<.001
73854588|NCT02152371|147255955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-15.55|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-23.58|-7.52|||Mixed Models Analysis|||Pre-Midday Meal||-7.52|-23.58|<.001
73854589|NCT02152371|147255955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-18.15|STANDARD_ERROR_OF_MEAN|4.58|<|0.001|TWO_SIDED|95.0|-27.18|-9.12|||Mixed Models Analysis|||Midday Meal 2-Hour Postprandial||-9.12|-27.18|<.001
73854590|NCT02152371|147255955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-14.96|STANDARD_ERROR_OF_MEAN|4.55||0.001|TWO_SIDED|95.0|-23.93|-5.99|||Mixed Models Analysis|||Pre-Evening Meal||-5.99|-23.93|.001
73854591|NCT02152371|147255955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-21.28|STANDARD_ERROR_OF_MEAN|5.68|<|0.001|TWO_SIDED|95.0|-32.46|-10.1|||Mixed Models Analysis|||Evening Meal 2-Hour Postprandial||-10.10|-32.46|<.001
73854592|NCT02152371|147255955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-19.48|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-28.77|-10.18|||Mixed Models Analysis|||3:00AM (Morning)||-10.18|-28.77|<.001
73854593|NCT02152371|147255956|SUPERIORITY_OR_OTHER_LEGACY||LS Means Difference|-2.41|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-3.19|-1.64|||Mixed Models Analysis|||||-1.64|-3.19|<.001
73854594|NCT02152371|147255957|SUPERIORITY_OR_OTHER_LEGACY||LS Means Diff|-13.19|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-19.55|-6.84|||MMRM|||||-6.84|-19.55|<.001
73854595|NCT02152371|147255964|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.66|||<|0.001|TWO_SIDED|95.0|3.7|12.0|||Regression, Logistic|||||12.00|3.70|<.001
73962553|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|1.78||0.406|TWO_SIDED|95.0|-4.96|2.01|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.01|-4.96|0.4060
73854596|NCT02152371|147255964|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio, log|5.71|||<|0.001|TWO_SIDED|95.0|3.35|9.73|||Regression, Logistic|||||9.73|3.35|<.001
73854597|NCT02152371|147255965|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.17|||<|0.001|TWO_SIDED|95.0|2.32|7.47|||Regression, Logistic|||||7.47|2.32|<.001
73854598|NCT02152371|147255966|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|2.09|6.23|||Regression, Logistic|||||6.23|2.09|<.001
73854599|NCT02152371|147255967|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.6|||<|0.001|TWO_SIDED|95.0|3.26|9.62|||Regression, Logistic|||||9.62|3.26|<.001
74025071|NCT02424539|147602984|OTHER||Mean Difference (Final Values)|-1.36|||<|0.001|TWO_SIDED|95.0|-1.83|-0.9|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.90|-1.83|<0.001
73854600|NCT05352412|147255969|OTHER|Mann-Whitney U|Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.32
73854601|NCT05352412|147255969|OTHER|Mann-Whitney U|Mann-Whitney U|0.39||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline survey compared with immediate follow-up survey||||0.39
73854602|NCT05352412|147255969|OTHER|Mann-Whitney U|Mann-Whitney U|0.21||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared with baseline survey||||0.21
73854603|NCT05352412|147255969|OTHER||Mann-Whitney U|0.19||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90 days post-discharge compared with baseline survey||||0.19
73854604|NCT05352412|147255969|OTHER||Mann-Whitney U|0.38||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline survey versus immediate follow-up||||0.38
73854605|NCT05352412|147255969|OTHER||Mann-Whitney U|0.25||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared with baseline survey||||0.25
73854606|NCT05352412|147255969|OTHER||Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90 days post-discharge compared with baseline survey||||0.07
73854607|NCT05352412|147255969|OTHER||Mann-Whitney U|0.03||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up between the two arms||||0.03
73854608|NCT05352412|147255969|OTHER||Mann-Whitney U|0.65||||0.65|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge comparison between the 2 arms||||0.65
73854609|NCT05352412|147255969|OTHER||Mann-Whitney U|0.97||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-days post discharge compared between the 2 arms||||0.97
73854610|NCT05352412|147255970|OTHER||Mann-Whitney U|0.77||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline comparison between the 2 arms||||0.77
73854611|NCT05352412|147255970|OTHER||Mann-Whitney U|0.85||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared with baseline survey||||0.85
73854612|NCT05352412|147255970|OTHER||Mann-Whitney U|0.38||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2-week post-discharge compared with baseline survey||||0.38
73854613|NCT05352412|147255970|OTHER||Mann-Whitney U|0.21||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post discharge compared with baseline survey||||0.21
73854614|NCT05352412|147255970|OTHER||Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared with baseline survey||||0.32
73962554|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|1.78||0.848|TWO_SIDED|95.0|-3.84|3.15|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.15|-3.84|0.8480
73962555|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|1.94||0.923|TWO_SIDED|95.0|-4.0|3.63|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.63|-4.00|0.9230
73962556|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|1.96||0.4421|TWO_SIDED|95.0|-5.36|2.34|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.34|-5.36|0.4421
74025072|NCT02424539|147602984|OTHER||Mean Difference (Final Values)|-1.46|||<|0.001|TWO_SIDED|95.0|-1.92|-0.99|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.99|-1.92|<0.001
74025073|NCT02424539|147602985|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.34|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.34|0.12|<0.001
74025074|NCT02424539|147602985|OTHER||Odds Ratio (OR)|0.17|||<|0.001|TWO_SIDED|95.0|0.1|0.29|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.29|0.10|<0.001
74025075|NCT02424539|147602986|OTHER||Mean Difference (Final Values)|-2.48|||<|0.001|TWO_SIDED|95.0|-3.23|-1.73|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.73|-3.23|<0.001
73854615|NCT05352412|147255970|OTHER||Mann-Whitney U|0.09||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 week post-discharge compared with baseline survey||||0.09
73854616|NCT05352412|147255970|OTHER||Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post-discharge compared with baseline survey||||0.07
73854617|NCT05352412|147255970|OTHER||Mann-Whitney U|0.26||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared between the 2 arms||||0.26
73854618|NCT05352412|147255970|OTHER||Mann-Whitney U|0.69||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared between the 2 arms||||0.69
73854619|NCT05352412|147255970|OTHER||Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post-discharge compared between the 2 arms||||0.32
73854620|NCT05352412|147255974|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
73854621|NCT05352412|147255974|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
73962557|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.44||0.2049|TWO_SIDED|95.0|-1.7|7.91|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||7.91|-1.70|0.2049
73962558|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|4.68|STANDARD_ERROR_OF_MEAN|2.4||0.0527|TWO_SIDED|95.0|-0.05|9.41|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||9.41|-0.05|0.0527
73962559|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|1.82||0.3699|TWO_SIDED|95.0|-5.21|1.94|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.94|-5.21|0.3699
73962560|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.83||0.7945|TWO_SIDED|95.0|-4.06|3.11|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.11|-4.06|0.7945
73854622|NCT05352412|147255974|OTHER|Mann-Whitney U|Mann-Whitney U|0.12||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.12
73854623|NCT05352412|147255974|OTHER|Mann-Whitney U|Mann-Whitney U|0.12||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.12
73854624|NCT05352412|147255975|OTHER|Mann-Whitney U|Mann-Whitney U|0.48||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.48
73854625|NCT05352412|147255975|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
73854626|NCT05352412|147255975|OTHER|Mann-Whitney U|Mann-Whitney U|0.17||||0.17|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.17
73854627|NCT05352412|147255975|OTHER|Mann-Whitney U|Mann-Whitney U|0.42||||0.42|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.42
73962561|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|2.03||0.941|TWO_SIDED|95.0|-4.13|3.83|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.83|-4.13|0.9410
74025076|NCT02424539|147602986|OTHER||Mean Difference (Final Values)|-2.27|||<|0.001|TWO_SIDED|95.0|-3.03|-1.52|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.52|-3.03|<0.001
74025077|NCT02424539|147602987|OTHER||Mean Difference (Final Values)|-0.11||||0.442|TWO_SIDED|95.0|-0.38|0.17|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.17|-0.38|0.442
73854628|NCT05352412|147255976|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline||||1.00
73854629|NCT05352412|147255976|OTHER|Mann-Whitney U|Mann-Whitney U|0.11||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up||||0.11
73854630|NCT05352412|147255976|OTHER|Mann-Whitney U|Mann-Whitney U|0.89||||0.89|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up||||0.89
73854631|NCT05352412|147255976|OTHER|Mann-Whitney U|Mann-Whitney U|0.55||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.55
73854632|NCT05352412|147255977|OTHER|Mann-Whitney U|Mann-Whitney U|0.66||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.66
73854633|NCT05352412|147255977|OTHER|Mann-Whitney U|Mann-Whitney U|0.2||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up post randomization||||0.20
73962562|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|2.05||0.486|TWO_SIDED|95.0|-5.44|2.59|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.59|-5.44|0.4860
73962563|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|3.05|STANDARD_ERROR_OF_MEAN|2.62||0.2448|TWO_SIDED|95.0|-2.1|8.2|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||8.20|-2.10|0.2448
73962564|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|4.96|STANDARD_ERROR_OF_MEAN|2.58||0.0551|TWO_SIDED|95.0|-0.11|10.04|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||10.04|-0.11|0.0551
73962565|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|1.05||0.247|TWO_SIDED|95.0|-3.26|0.84|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.84|-3.26|0.2470
73962566|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-1.98|STANDARD_ERROR_OF_MEAN|1.04||0.057|TWO_SIDED|95.0|-4.01|0.06|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.06|-4.01|0.0570
73962567|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|1.14||0.917|TWO_SIDED|95.0|-2.36|2.12|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.12|-2.36|0.9170
73962568|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.14||0.4991|TWO_SIDED|95.0|-3.0|1.46|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.46|-3.00|0.4991
73962569|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.44||0.2377|TWO_SIDED|95.0|-1.12|4.52|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.52|-1.12|0.2377
73962570|NCT02528188|147460969|SUPERIORITY||LS Mean Difference|3.26|STANDARD_ERROR_OF_MEAN|1.44||0.0238|TWO_SIDED|95.0|0.43|6.08|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||6.08|0.43|0.0238
73962571|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|1.08||0.0142|TWO_SIDED|95.0|0.53|4.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.78|0.53|0.0142
73962572|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|2.56|6.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||6.78|2.56|<0.0001
73962573|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|1.45||0.1371|TWO_SIDED|95.0|-0.69|4.99|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.99|-0.69|0.1371
73962574|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.46||0.8524|TWO_SIDED|95.0|-2.6|3.14|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.14|-2.60|0.8524
73962575|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|3.8||0.5253|TWO_SIDED|95.0|-9.93|5.09|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.09|-9.93|0.5253
73962576|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|3.71||0.5381|TWO_SIDED|95.0|-5.04|9.62|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||9.62|-5.04|0.5381
74025078|NCT02424539|147602987|OTHER||Mean Difference (Final Values)|-0.3||||0.035|TWO_SIDED|95.0|-0.57|-0.02|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.02|-0.57|0.035
74025079|NCT02424539|147602988|OTHER||Mean Difference (Final Values)|1.88||||0.004|TWO_SIDED|95.0|0.6|3.16|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||3.16|0.60|0.004
74025080|NCT02424539|147602988|OTHER||Mean Difference (Final Values)|2.67|||<|0.001|TWO_SIDED|95.0|1.38|3.95|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||3.95|1.38|<0.001
74025081|NCT04893265|147602998|SUPERIORITY||Mean Difference (Net)|0.0854|STANDARD_ERROR_OF_MEAN|0.1122||0.4471|TWO_SIDED|95.0|-0.1352|0.306|||Mixed Models Analysis|||||0.3060|-0.1352|0.4471
74025082|NCT04893265|147602999|SUPERIORITY||Odds Ratio (OR)|0.8378|||<|0.05|TWO_SIDED|95.0|0.4284|1.6385|||Mixed Models Analysis|Adjusted for Demographics, COVID-19 Cases Per 100K , Test Access, Social Network, Knowledge, Test Value with random intercepts for participation mode|Adjusted odds ratio|||1.6385|0.4284|<0.05
74025083|NCT04893265|147603000|SUPERIORITY||Odds Ratio (OR)|1.4306|||<|0.05|TWO_SIDED|95.0|0.6166|3.3192|||Mixed Models Analysis|Adjusted for Demographics, COVID-19 Cases Per 100K , Test Access, Social Network, Knowledge, Test Value with random intercepts for participation mode|Adjusted odds ratio|||3.3192|0.6166|<0.05
74025084|NCT04893265|147603001|SUPERIORITY||Mean Difference (Final Values)|0.08661|STANDARD_ERROR_OF_MEAN|0.08125|||TWO_SIDED|95.0|-0.07311|0.2463|||||Adjusted for Demographics, COVID Cases Per 100,000 Population, Test Access, Social Network, Knowledge, and Test Value with random intercepts for Dyad and Individual|||0.2463|-0.07311|
74025085|NCT03090191|147603006|SUPERIORITY|Lower bound of confidence interval greater than 20% demonstrate vaccine efficacy.|Vaccine efficacy|31.0|||||TWO_SIDED|96.4|-38.7|66.6|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 96.4% CI was estimated using Clopper-Pearson-Method.|||66.6|-38.7|
74025086|NCT03090191|147603007|SUPERIORITY|Lower bound of confidence interval greater than 20% demonstrate vaccine efficacy.|Vaccine efficacy|28.6|||||TWO_SIDED|96.4|-28.4|61.0|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 96.4% CI was estimated using Clopper-Pearson-Method.|||61.0|-28.4|
74025087|NCT03090191|147603016|SUPERIORITY||Vaccine efficacy|11.1|||||TWO_SIDED|98.2|-110.7|62.5|||||VE = 100\*(1 - Hazard Ratio). 98.2% CI was estimated using Proportional Means Model.|||62.5|-110.7|
74025088|NCT03090191|147603017|SUPERIORITY|||||||0.0172|||||||Wilcoxon Rank Sum Test (2-sided)|||||||0.0172
74025089|NCT03090191|147603018|SUPERIORITY||Ratio of proportions|0.0|||||TWO_SIDED|98.2|0.0|0.81||||||||0.81|0.00|
74025090|NCT03090191|147603019|SUPERIORITY||Vaccine efficacy|-69.3|||||TWO_SIDED|98.2|-1533.1|75.6|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of recurrent CDI incidence between Clostridium difficile vaccine group and placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||75.6|-1533.1|
74025091|NCT03090191|147603020|SUPERIORITY||Vaccine efficacy|14.9|||||TWO_SIDED|98.2|-74.6|58.5|||||VE = 100\*(1 - Hazard Ratio). 98.2% CI was estimated using Proportional Means Model|||58.5|-74.6|
74025092|NCT03090191|147603021|SUPERIORITY||Vaccine efficacy|-102.4|||||TWO_SIDED|98.2|-1770.1|67.2|||||VE = 100\*(1 - IRR), where IRR= the calculated ratio of recurrent CDI incidence between the Clostridium difficile vaccine group and the placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||67.2|-1770.1|
74025093|NCT03090191|147603022|SUPERIORITY||Vaccine efficacy|12.0|||||TWO_SIDED|98.2|-246.7|78.5|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||78.5|-246.7|
73854634|NCT05352412|147255977|OTHER|Mann-Whitney U|Mann-Whitney U|0.85||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up post randomization||||0.85
73854635|NCT05352412|147255977|OTHER|Mann-Whitney U|Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up post randomization||||0.07
74025094|NCT02432807|147603037|SUPERIORITY|||||||0.2219|||||||Chi-squared|||||||0.2219
73854636|NCT04382586|147255978|SUPERIORITY||Odds Ratio (OR)|1.61||||0.4099|TWO_SIDED|95.0|0.349|7.391|||Unstratified 1-sided Fisher's exact test|||||7.391|0.349|0.4099
73854637|NCT04382586|147255979|SUPERIORITY||Hazard Ratio (HR)|0.918||||0.7619|TWO_SIDED|95.0|0.511|1.648|||Log Rank|||||1.648|0.511|0.7619
74025095|NCT02432807|147603038|SUPERIORITY|||||||0.1817|||||||Chi-squared|||||||0.1817
74025096|NCT01021007|147603057|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.005
74025097|NCT01021007|147603058|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.05
74025098|NCT01021007|147603059|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.05
74025099|NCT03047005|147603060|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.07|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.||||||.07
74025100|NCT03047005|147603061|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.01|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.||||||.01
74025101|NCT01929083|147603071|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.04
74025102|NCT01929083|147603072|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.003
74025103|NCT01929083|147603073|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||P value for incidence of fatigue/malaise|Fisher Exact|||||||0.04
74025104|NCT01929083|147603073|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||p values for incidence of headache|Fisher Exact|||||||0.60
74025105|NCT01929083|147603073|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||p value for incidence of mood changes|Fisher Exact|||||||0.23
73854638|NCT06099223|147256003|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73854639|NCT06099223|147256004|SUPERIORITY|||||||0.029|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.029
73854640|NCT06099223|147256006|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73854641|NCT06099223|147256007|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
73854642|NCT06099223|147256008|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
73854643|NCT06099223|147256009|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
73854644|NCT06099223|147256010|SUPERIORITY|||||||0.11|||||||Fisher Exact|||||||0.11
73854645|NCT06099223|147256011|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
73854646|NCT06099223|147256012|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
73904361|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9914|TWO_SIDED|95.0|-1.63|1.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.65|-1.63|0.9914
73962577|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|7.27|STANDARD_ERROR_OF_MEAN|6.44||0.2694|TWO_SIDED|95.0|-5.99|20.54|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||20.54|-5.99|0.2694
73962578|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|-9.34|STANDARD_ERROR_OF_MEAN|6.05||0.1349|TWO_SIDED|95.0|-21.8|3.11|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.11|-21.80|0.1349
74025106|NCT01929083|147603073|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||p value for incidence of breast tenderness|Fisher Exact|||||||0.23
74025107|NCT01929083|147603073|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||p value for incidence of hypotension|Fisher Exact|||||||0.48
73854647|NCT06099223|147256013|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
73854648|NCT06099223|147256014|SUPERIORITY|||||||0.147|||||||t-test, 2 sided|||||||0.147
73854649|NCT06099223|147256015|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
73854650|NCT06099223|147256016|SUPERIORITY|||||||0.41|||||||Chi-squared|||||||0.41
74025108|NCT01929083|147603073|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||p value for incidence of vertigo requiring discontinuation of therapy|Fisher Exact|||||||0.48
74025109|NCT01929083|147603074|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.02
73854651|NCT06099223|147256017|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
73854652|NCT06099223|147256018|SUPERIORITY|||||||0.58|||||||Chi-squared|||||||0.58
73854653|NCT06099223|147256020|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
73854654|NCT06099223|147256021|SUPERIORITY|||||||0.919|||||||ANCOVA|||||||0.919
73854655|NCT02644096|147256033|SUPERIORITY_OR_OTHER||||||<|0.05||||||Changes in physical function after 3 months|unpaired t-test|||"Power calculation in this study was based on findings in a previous cross-sectional study.~The physical dimensions in health status was the primary outcome variable. The mean physical score was 49.4, SD was 26.1; alpha in this study was set to 5% and β to 20%. We considered that the intervention could lead to an improvement of 50% in the physical health score and were willing to overlook a difference in score of 12. When the sample size was calculated, 68 patients were needed in both groups."||||<0.05
73854656|NCT03224403|147256047|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
73854657|NCT03224403|147256047|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
73854658|NCT03224403|147256047|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
73854659|NCT03224403|147256047|SUPERIORITY|||||||0.035||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.035
73854660|NCT03224403|147256047|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||<0.001
73854661|NCT03224403|147256048|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
73854662|NCT03224403|147256048|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
73854663|NCT03224403|147256048|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
73854664|NCT03224403|147256048|SUPERIORITY|||||||0.671||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.671
73854665|NCT03224403|147256048|SUPERIORITY|||||||0.487||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.487
74025110|NCT01929083|147603075|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.002
74025111|NCT01929083|147603076|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||p value for bradycardia|Fisher Exact|||||||0.65
74025112|NCT01929083|147603076|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED|||||p value for burning at infusion site|Fisher Exact|||||||>0.99
73904362|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9682|TWO_SIDED|95.0|-1.39|1.44||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.44|-1.39|0.9682
73904363|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.2008|TWO_SIDED|95.0|-2.96|0.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.64|-2.96|0.2008
73904364|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.7988|TWO_SIDED|95.0|-2.07|1.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.60|-2.07|0.7988
73904365|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.7||||0.3764|TWO_SIDED|95.0|-2.27|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.87|-2.27|0.3764
73904366|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.4177|TWO_SIDED|95.0|-2.98|1.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.25|-2.98|0.4177
73904367|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.6494|TWO_SIDED|95.0|-2.67|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.68|-2.67|0.6494
73904368|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.4674|TWO_SIDED|95.0|-2.54|1.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.18|-2.54|0.4674
73962579|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.81||0.0264|TWO_SIDED|95.0|0.21|3.38|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.38|0.21|0.0264
73962580|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.8||0.0098|TWO_SIDED|95.0|0.5|3.65|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.65|0.50|0.0098
74025113|NCT01929083|147603076|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED|||||p value for transient QTc interval \> 500 ms|Fisher Exact|||||||> 0.99
74025114|NCT01929083|147603077|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.43
74025115|NCT01929083|147603078|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.36
74025116|NCT01929083|147603079|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.0001
74025117|NCT01929083|147603080|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.0001
74088311|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.13||0.3057|TWO_SIDED|95.0|0.63|1.16|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.16|0.63|0.3057
73962581|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|1.1||0.0937|TWO_SIDED|95.0|-0.31|4.01|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.01|-0.31|0.0937
73962582|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|1.48|STANDARD_ERROR_OF_MEAN|1.11||0.1838|TWO_SIDED|95.0|-0.7|3.67|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.67|-0.70|0.1838
73854666|NCT03224403|147256049|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854667|NCT03224403|147256050|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854668|NCT03224403|147256051|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854669|NCT03224403|147256052|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854670|NCT03224403|147256053|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854671|NCT03224403|147256054|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854672|NCT03224403|147256055|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854673|NCT03224403|147256056|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854674|NCT03224403|147256057|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854675|NCT03224403|147256058|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854676|NCT03224403|147256059|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854677|NCT03224403|147256060|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854678|NCT03224403|147256061|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854679|NCT03224403|147256062|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854680|NCT03224403|147256063|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854681|NCT03224403|147256064|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854682|NCT03224403|147256065|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73854683|NCT03224403|147256066|SUPERIORITY|||||||0.007|||||||Regression, Logistic|||||||0.007
73854684|NCT03224403|147256067|SUPERIORITY|||||||0.026|||||||Regression, Logistic|||||||0.026
73854685|NCT03224403|147256068|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.080
73854686|NCT02908685|147256072|SUPERIORITY|This is the first end point and first family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.55||||0.0156|TWO_SIDED|95.0|0.3|2.81|||Mixed Model Repeated Measure Analysis|||||2.81|0.30|0.0156
73854687|NCT02908685|147256073|SUPERIORITY|This is the second end point and second family tested in the hierarchical testing. Logistic Regression Model.The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|2.35||||0.0469|TWO_SIDED|95.0|1.01|5.44||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Wald test|||||5.44|1.01|0.0469
73930777|NCT02566759|147391428|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.872|||||TWO_SIDED|90.0|0.8145|0.9296||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.9296|0.8145|
73930778|NCT02566759|147391428|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.9135|||||TWO_SIDED|90.0|0.8062|1.0209|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||1.0209|0.8062|
73930779|NCT02566759|147391428|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|0.5|||||TWO_SIDED|90.0|0.4324|0.5777||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||0.5777|0.4324|
73930780|NCT02566759|147391428|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|2.563|||||TWO_SIDED|90.0|2.1|3.1275||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||3.1275|2.1000|
73930781|NCT02566759|147391429|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.8505|||<|0.001|TWO_SIDED|90.0|0.7925|0.9084|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.9084|0.7925|<0.001
73930782|NCT02566759|147391429|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.8415|||<|0.001|TWO_SIDED|90.0|0.7618|0.9212|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||0.9212|0.7618|<0.001
73930783|NCT02566759|147391429|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|0.543|||||TWO_SIDED|90.0|0.4797|0.6149||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||0.6149|0.4797|
73930784|NCT02566759|147391429|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|2.336|||||TWO_SIDED|90.0|1.9592|2.7854||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||2.7854|1.9592|
73930785|NCT01126541|147391432|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided).||||||0.465|||||||Wilcoxon (Mann-Whitney)|||Change from Day 1 to Week 24 (initial treatment)||||0.465
73854688|NCT02908685|147256074|SUPERIORITY|This is the third end point and third family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.59||||0.0469|TWO_SIDED|95.0|0.55|2.62||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||2.62|0.55|0.0469
73854689|NCT02908685|147256075|SUPERIORITY|This is one of the two end points in family four in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|0.58||||0.3902|TWO_SIDED|95.0|-0.53|1.69||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||1.69|-0.53|0.3902
73854690|NCT02908685|147256076|SUPERIORITY|This is one of the two end points in family four in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-2.05||||0.3902|TWO_SIDED|95.0|-6.67|2.56||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||2.56|-6.67|0.3902
73854691|NCT02908685|147256077|SUPERIORITY|This is the sixth endpoint and the fifth family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.55||||0.3902|TWO_SIDED|95.0|0.93|4.17||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||4.17|0.93|0.3902
73854692|NCT02908685|147256078|SUPERIORITY|This is the seventh endpoint and the sixth family tested in the hierarchical testing. Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|1.38||||0.3902|TWO_SIDED|95.0|0.7|2.74||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Wald-test|||CGI Improved||2.74|0.70|0.3902
73854693|NCT02908685|147256079|SUPERIORITY|Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|2.0||||0.043|TWO_SIDED|95.0|1.02|3.93|||Wald test|||||3.93|1.02|0.0430
73854694|NCT02908685|147256081|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|0.64||||0.1328|TWO_SIDED|95.0|-0.2|1.47|||Mixed Model Repeated Measure Analysis|||||1.47|-0.20|0.1328
73854695|NCT02908685|147256082|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.97||||0.103|TWO_SIDED|95.0|-0.4|4.34|||Mixed Model Repeated Measure Analysis|||||4.34|-0.40|0.1030
73854696|NCT02908685|147256083|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.34||||0.0451|TWO_SIDED|95.0|0.05|4.62|||Mixed Model Repeated Measure Analysis|||||4.62|0.05|0.0451
73854697|NCT02908685|147256084|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.28||||0.0489|TWO_SIDED|95.0|0.01|2.56|||Mixed Model Repeated Measure Analysis|||||2.56|0.01|0.0489
73854698|NCT02908685|147256085|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.16||||0.0326|TWO_SIDED|95.0|0.18|4.14|||Mixed Model Repeated Measure Analysis|||||4.14|0.18|0.0326
73854699|NCT02908685|147256086|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-2.87||||0.3029|TWO_SIDED|95.0|-8.36|2.62|||Mixed Model Repeated Measure Analysis|||||2.62|-8.36|0.3029
73854700|NCT02908685|147256087|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.28||||0.4937|TWO_SIDED|95.0|-2.42|4.99|||Mixed Model Repeated Measure Analysis|||||4.99|-2.42|0.4937
73854701|NCT02908685|147256088|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.35||||0.3967|TWO_SIDED|95.0|-3.11|7.8|||Mixed Model Repeated Measure Analysis|||||7.80|-3.11|0.3967
73854702|NCT02908685|147256089|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.96||||0.6704|TWO_SIDED|95.0|-10.78|16.7|||Mixed Model Repeated Measure Analysis|||||16.70|-10.78|0.6704
73854703|NCT02908685|147256090|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-0.43||||0.8856|TWO_SIDED|95.0|-6.3|5.45|||Mixed Model Repeated Measure Analysis|||||5.45|-6.30|0.8856
73854704|NCT02908685|147256091|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.45||||0.1778|TWO_SIDED|95.0|-0.68|3.57|||Mixed Model Repeated Measure Analysis|||||3.57|-0.68|0.1778
73962583|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|1.05||0.0025|TWO_SIDED|95.0|1.12|5.25|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.25|1.12|0.0025
73854705|NCT02908685|147256092|SUPERIORITY|Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|1.21||||0.6636|TWO_SIDED|95.0|0.52|2.83|||Wald-test|||CGI No Change or Improved||2.83|0.52|0.6636
73962584|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|3.55|STANDARD_ERROR_OF_MEAN|1.04||0.0007|TWO_SIDED|95.0|1.51|5.6|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.60|1.51|0.0007
73962585|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|1.94|STANDARD_ERROR_OF_MEAN|1.31||0.1373|TWO_SIDED|95.0|-0.62|4.51|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.51|-0.62|0.1373
73854706|NCT01691014|147256115|SUPERIORITY_OR_OTHER|||||||0.99|||||||Fisher Exact|||DAS28: Month 3: Continuous variables were compared between treatment groups using one way analysis of variance (ANOVA).||||0.990
73854707|NCT01691014|147256115|SUPERIORITY_OR_OTHER|||||||0.586|||||||Fisher Exact|||DAS28: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.||||0.586
73854708|NCT01691014|147256115|SUPERIORITY_OR_OTHER|||||||0.98|||||||Fisher Exact|||DAS28: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.||||0.980
73854709|NCT01691014|147256116|SUPERIORITY_OR_OTHER|||||||0.945|||||||Fisher Exact|||HAQ: Baseline: Continuous variables were compared between treatment groups using one way ANOVA.||||0.945
73854710|NCT01691014|147256116|SUPERIORITY_OR_OTHER|||||||0.458|||||||Fisher Exact|||HAQ: Month 3: Continuous variables were compared between treatment groups using one way ANOVA.||||0.458
73854711|NCT01691014|147256116|SUPERIORITY_OR_OTHER|||||||0.896|||||||Fisher Exact|||HAQ: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.||||0.896
73854712|NCT01691014|147256116|SUPERIORITY_OR_OTHER|||||||0.39|||||||Fisher Exact|||HAQ: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.||||0.390
73854713|NCT02370537|147256118|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-square means (LSmeans) for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% Confidence Intervals (CIs) by degree of pancreatic exocrine function using level of FEC were exponentiated.|Geometric least-squares (GLS) Mean Ratio|0.75|||||TWO_SIDED|90.0|0.52|1.1|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.10|0.52|
73854714|NCT02370537|147256118|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean ratio|0.48|||||TWO_SIDED|90.0|0.32|0.72|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.72|0.32|
73854715|NCT02370537|147256118|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||TWO_SIDED|90.0|0.44|0.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.82|0.44|
73854716|NCT02370537|147256119|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.28|||||TWO_SIDED|90.0|0.84|1.93|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.93|0.84|
73854717|NCT02370537|147256119|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.8|||||TWO_SIDED|90.0|0.51|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.25|0.51|
73854718|NCT02370537|147256119|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.29|||||TWO_SIDED|90.0|0.92|1.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.82|0.92|
74025118|NCT00087438|147603082|SUPERIORITY_OR_OTHER|||||||0.013||||||Test statistic = \[ln(estimated hazard rate) - ln(hypothesized hazard rates)\] / \[1/square root (number of patients with local progression by two years\]. Reject null hypothesis at an alpha level of 0.05 if test statistics is less than -1.645.|z-test, one-sided|||Null hypothesis = 60% two-year local control (0.02128/mo. hazard rate); alternative = 80% (0.0093/mo.) assuming at least approximately exponential distribution of time to local progression. Using the asymptotic properties of the ratio of the logarithms of hazard rates, less than 18 cases of local progression were required for a Type I error rate of 0.05 with 80% power to detect a difference in local control rates at least this large. Hazard rate estimated using life table two-year estimates.||||0.013
74025119|NCT00811252|147603098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32|STANDARD_ERROR_OF_MEAN|1.01||0.0011|TWO_SIDED|95.0|-5.31|-1.34||Since p-value \<0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.||-1.34|-5.31|0.0011
74025120|NCT00811252|147603098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.48|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|-7.5|-3.46||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-3.46|-7.50|<0.0001
74025121|NCT00811252|147603099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13|STANDARD_ERROR_OF_MEAN|0.94||0.024|TWO_SIDED|95.0|-3.98|-0.28||Since p-value \<0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.28|-3.98|0.0240
74025122|NCT00811252|147603099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.22|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-6.1|-2.34||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-2.34|-6.10|<0.0001
74025123|NCT00811252|147603100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.85||0.2134|TWO_SIDED|95.0|-2.72|0.61||Since p-value \>0.05, hierarchically testing stopped here.|ANCOVA|||||0.61|-2.72|0.2134
74025124|NCT00811252|147603100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.86||0.0002|TWO_SIDED|95.0|-4.99|-1.6||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-1.60|-4.99|0.0002
74025125|NCT00811252|147603101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.7||0.6879|TWO_SIDED|95.0|-1.67|1.1||A nominal p-value is provided.|ANCOVA|||||1.10|-1.67|0.6879
74025126|NCT00811252|147603101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.72||0.0827|TWO_SIDED|95.0|-2.65|0.16||A nominal p-value is provided.|ANCOVA|||||0.16|-2.65|0.0827
74025127|NCT00811252|147603102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.55||0.4482|TWO_SIDED|95.0|-1.49|0.66||A nominal p-value is provided.|ANCOVA|||||0.66|-1.49|0.4482
74025128|NCT00811252|147603102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.56||0.7971|TWO_SIDED|95.0|-0.95|1.24||A nominal p-value is provided.|ANCOVA|||||1.24|-0.95|0.7971
74025129|NCT00811252|147603103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.29|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|-6.32|-2.26||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-2.26|-6.32|<0.0001
74025130|NCT00811252|147603104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|STANDARD_ERROR_OF_MEAN|0.74||0.0015|TWO_SIDED|95.0|-3.8|-0.91||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.91|-3.80|0.0015
74025131|NCT00811252|147603105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.88|-0.32||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.32|-0.88|<0.0001
74025132|NCT00811252|147603106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.31||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.31|-0.82|<0.0001
74025133|NCT00811252|147603107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.23||0.0552|TWO_SIDED|95.0|-0.88|0.01||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||0.01|-0.88|0.0552
74025134|NCT00811252|147603108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.0008|TWO_SIDED|95.0|0.26|0.7||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic|||||0.70|0.26|0.0008
74025135|NCT00811252|147603109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.009|TWO_SIDED|95.0|0.27|0.83||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic|||||0.83|0.27|0.0090
74025136|NCT01244737|147603133|OTHER||Pearson correlation co-efficient|0.8|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||This is a diagnostic test of FLT uptake (SUV max) as a predictor of cellular proliferation (MIB) and is performed as an analysis of correlation using each evaluable participant enrolled in either Arm 1 (New Diagnosis) or Arm 2 (Possible recurrent tumor). The groups (Arm 1 and Arm 2) provide pathways for enrollment. Correlation between the two measures of outcome (SUV max and MIB) is evaluated.||||< 0.001
74025137|NCT01244737|147603136|OTHER|Paired T-test to assess change in FLT uptake (SUV max) with chemotherapy.||||||0.04||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.04
74025138|NCT03664726|147603175|SUPERIORITY|||||||0.0034||||||Comparison of differences by group|ANOVA|||||||0.0034
74025139|NCT03664726|147603176|SUPERIORITY|||||||0.76|||||||ANOVA|||||||0.76
74025140|NCT03664726|147603177|SUPERIORITY|||||||0.77|||||||ANOVA|||||||0.77
74088312|NCT02709486|147730012|SUPERIORITY||LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.13||0.2056|TWO_SIDED|95.0|0.61|1.11|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.11|0.61|0.2056
73962586|NCT02528188|147460977|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|1.32||0.996|TWO_SIDED|95.0|-2.59|2.6|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||2.60|-2.59|0.9960
73962587|NCT02528188|147460979|SUPERIORITY|||||||0.0823|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0823
74084961|NCT01923311|147723573|EQUIVALENCE|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG Cmax in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG Cmax is 0.28 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|146.68|||||TWO_SIDED|90.0|127.35|168.94||||||To determine whether the proposed EVG dose in children achieves similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).||168.94|127.35|
73962588|NCT02528188|147460979|SUPERIORITY|||||||0.0049|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0049
73962589|NCT02528188|147460979|SUPERIORITY|||||||0.0718|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0718
73854719|NCT02370537|147256120|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.63|1.28|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.28|0.63|
73854720|NCT02370537|147256120|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.58|||||TWO_SIDED|90.0|0.39|0.85|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.85|0.39|
73854721|NCT02370537|147256120|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.75|||||TWO_SIDED|90.0|0.55|1.0|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.00|0.55|
73930786|NCT01126541|147391432|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.161|||||||Wilcoxon (Mann-Whitney)|||Arm A vs. Arm B: Change from 1st retreatment to 24 weeks after||||0.161
73930787|NCT01126541|147391432|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.524|||||||Student t-test|||Arm A vs. Arm B: Change from 2nd retreatment to 24 weeks after||||0.524
73930788|NCT01126541|147391433|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean plus or minus (±)SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)|Adjusted difference|51.38|STANDARD_DEVIATION|92.0|||TWO_SIDED|95.0|-131.22|233.98|||||Covariate analysis with baseline DAS28-CRP value as covariate|||233.98|-131.22|
73930789|NCT01126541|147391453|SUPERIORITY_OR_OTHER|||||||0.389|||||||Wilcoxon (Mann-Whitney)|||Day 1 to Week 104||||0.389
73930790|NCT01126541|147391453|SUPERIORITY_OR_OTHER|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||1st retreatment to Week 104||||0.374
73930791|NCT01126541|147391453|SUPERIORITY_OR_OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||Weel 24 to Week 104||||0.277
73930792|NCT01126541|147391454|SUPERIORITY_OR_OTHER|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||Total cortisone: Week 24 to Week 104||||0.278
73962590|NCT02528188|147460979|SUPERIORITY|||||||0.1947|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1947
73962591|NCT02528188|147460980|SUPERIORITY|||||||0.0229|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0229
73962592|NCT02528188|147460980|SUPERIORITY|||||||0.0029|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0029
73904369|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.4709|TWO_SIDED|95.0|-3.85|1.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.81|-3.85|0.4709
73904370|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.4128|TWO_SIDED|95.0|-1.7|4.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||4.07|-1.70|0.4128
73904371|NCT01227564|147338838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.9478|TWO_SIDED|95.0|-2.41|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.58|-2.41|0.9478
73904372|NCT01227564|147338839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.7146|TWO_SIDED|95.0|-3.4|2.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||2.35|-3.40|0.7146
73904373|NCT01227564|147338839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||0.2733|TWO_SIDED|95.0|-4.6|1.33||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||1.33|-4.60|0.2733
73904374|NCT01227564|147338839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.3969|TWO_SIDED|95.0|-3.62|1.46||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||1.46|-3.62|0.3969
73904375|NCT01227564|147338839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.8566|TWO_SIDED|95.0|-2.43|2.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||2.92|-2.43|0.8566
73930793|NCT01126541|147391454|SUPERIORITY_OR_OTHER|||||||0.887|||||||Wilcoxon (Mann-Whitney)|||Oral cortisone: Week 24 to Week 104||||0.887
73930794|NCT01126541|147391454|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||IV cortisone: Week 24 to Week 104||||<0.001
73930795|NCT01532687|147391471|SUPERIORITY|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.017|||||||Gehan-Wilcoxon|||Statistical results are for the full randomized population (n = 54). The study was originally designed with overall one-sided alpha of 5%, where a total of 73 patients (36 in the gemcitabine + placebo arm, and 37 in the gemcitabine + pazopanib arm) were required to achieve 80% power to detect a 2.5 month increase in median PFS (a hazard ratio of 0.55) between the two treatment arms. Study was closed early by the sponsor due to slow accrual and funds and thus was under powered.||||0.017
73930796|NCT01532687|147391471|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.195|||||||Gehan-Wilcoxon|||Comparison between the two arms for the liposarcoma subgroup||||0.195
74025141|NCT03119649|147603199|SUPERIORITY||Difference in LS Means|-3.3|STANDARD_ERROR_OF_MEAN|4.15||0.4291|TWO_SIDED|95.0|-11.6|5.0||P-value obtained from the Mixed Effects Model for Repeated Measures (MMRM) analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||5.0|-11.6|0.4291
73854722|NCT02370537|147256121|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.52|||||TWO_SIDED|90.0|0.37|0.73|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.73|0.37|
73854723|NCT02370537|147256121|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.46|||||TWO_SIDED|90.0|0.32|0.67|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.67|0.32|
73854724|NCT02370537|147256121|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.53|||||TWO_SIDED|90.0|0.4|0.7|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.70|0.40|
73854725|NCT02370537|147256122|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-squares LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.77|1.36|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.36|0.77|
73854726|NCT02370537|147256122|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS mean Ratio|0.92|||||TWO_SIDED|90.0|0.67|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.25|0.67|
73854727|NCT02370537|147256122|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.11|||||TWO_SIDED|90.0|0.88|1.4|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.40|0.88|
73854728|NCT02370537|147256123|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean|0.68|||||TWO_SIDED|90.0|0.49|0.92|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.92|0.49|
73854729|NCT02370537|147256123|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||TWO_SIDED|90.0|0.42|0.84|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.84|0.42|
73854730|NCT02370537|147256123|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.7|||||TWO_SIDED|90.0|0.54|0.9|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.90|0.54|
73962593|NCT02528188|147460980|SUPERIORITY|||||||0.0266|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0266
73962594|NCT02528188|147460980|SUPERIORITY|||||||0.1835|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1835
73904376|NCT01227564|147338839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.346|TWO_SIDED|95.0|-3.98|1.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||1.42|-3.98|0.3460
73904377|NCT01227564|147338839|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.52||||0.6582|TWO_SIDED|95.0|-2.86|1.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||1.82|-2.86|0.6582
73904378|NCT01227564|147338841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.7537|TWO_SIDED|95.0|-18.36|13.36||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||13.36|-18.36|0.7537
73904379|NCT01227564|147338841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.51||||0.1266|TWO_SIDED|95.0|-28.86|3.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||3.65|-28.86|0.1266
73904380|NCT01227564|147338841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.96||||0.6724|TWO_SIDED|95.0|-28.34|18.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||18.41|-28.34|0.6724
73904381|NCT01227564|147338841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7||||0.017|TWO_SIDED|95.0|-53.89|-5.5||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||-5.50|-53.89|0.0170
73904382|NCT01227564|147338841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.94||||0.3196|TWO_SIDED|95.0|-92.67|30.78||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||30.78|-92.67|0.3196
73962595|NCT02528188|147460981|SUPERIORITY||Odds Ratio (OR)|0.63||||0.0076|TWO_SIDED|95.0|0.45|0.88|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||0.88|0.45|0.0076
73962596|NCT02528188|147460981|SUPERIORITY||Odds Ratio (OR)|0.67||||0.0187|TWO_SIDED|95.0|0.48|0.94|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||0.94|0.48|0.0187
73962597|NCT02528188|147460982|SUPERIORITY|||||||0.0074|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0074
73962598|NCT02528188|147460982|SUPERIORITY|||||||0.0162|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0162
73962599|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|1.15||||0.1136|TWO_SIDED|95.0|0.97|1.38|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.38|0.97|0.1136
74025142|NCT03119649|147603199|SUPERIORITY||Difference in LS Means|-4.1|STANDARD_ERROR_OF_MEAN|4.32||0.3477|TWO_SIDED|95.0|-12.8|4.6||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||4.6|-12.8|0.3477
73904383|NCT01227564|147338841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-64.97||||0.049|TWO_SIDED|95.0|-129.64|-0.31||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||-0.31|-129.64|0.0490
73904384|NCT01227564|147338841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.04||||0.2969|TWO_SIDED|95.0|-14.7|46.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||46.79|-14.70|0.2969
73904385|NCT01227564|147338841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.2||||0.0973|TWO_SIDED|95.0|-57.42|5.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||5.03|-57.42|0.0973
73904386|NCT01227564|147338842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.6653|TWO_SIDED|95.0|-7.94|5.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||5.10|-7.94|0.6653
73904387|NCT01227564|147338842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48||||0.4613|TWO_SIDED|95.0|-4.2|9.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||9.15|-4.20|0.4613
73904388|NCT01227564|147338842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.771|TWO_SIDED|95.0|-4.18|5.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||5.61|-4.18|0.7710
73904389|NCT01227564|147338842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.02||||0.2328|TWO_SIDED|95.0|-1.99|8.04||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||8.04|-1.99|0.2328
73962600|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|1.08||||0.391|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.29|0.90|0.3910
74025143|NCT03119649|147603199|SUPERIORITY||Difference in LS Means|-15.8|STANDARD_ERROR_OF_MEAN|3.72|<|0.0001|TWO_SIDED|95.0|-23.2|-8.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||-8.3|-23.2|<0.0001
73962601|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7691|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.86|0.7691
73962602|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|0.88||||0.143|TWO_SIDED|95.0|0.73|1.05|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.05|0.73|0.1430
73904390|NCT01227564|147338842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3693|TWO_SIDED|95.0|-0.97|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||2.58|-0.97|0.3693
73854731|NCT01340625|147256173|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.84|||||TWO_SIDED|90.0|100.91|115.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||115.24|100.91|
73854732|NCT01340625|147256174|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.03|||||TWO_SIDED|90.0|96.74|111.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.88|96.74|
73854733|NCT01340625|147256175|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.97|||||TWO_SIDED|90.0|95.73|108.62|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.62|95.73|
73854734|NCT01340625|147256176|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.24|||||TWO_SIDED|90.0|90.04|102.86|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.86|90.04|
73854735|NCT01340625|147256177|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.8|||||TWO_SIDED|90.0|93.89|103.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.97|93.89|
73854736|NCT01340625|147256178|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.59|||||TWO_SIDED|90.0|94.91|104.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.50|94.91|
73854737|NCT00066703|147256179|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.717||||0.0002|TWO_SIDED|95.0|0.602|0.855|||Log Rank||T+OFS is the reference group in the estimation of the hazard ratio.|||0.855|0.602|.0002
73854738|NCT00066703|147256180|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.664|||<|0.0001|TWO_SIDED|95.0|0.548|0.804|||Log Rank||T+OFS is the reference group for the estimation of the hazard ratio.|||.804|.548|<.0001
73854739|NCT00066703|147256181|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.777||||0.02|TWO_SIDED|95.0|0.624|0.967|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio|||0.967|0.624|0.02
73854740|NCT00066703|147256182|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.84|TWO_SIDED|95.0|0.79|1.22|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio|||1.22|0.79|0.84
73854741|NCT01696968|147256183|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.91|1.07|||Poisson regression|||||1.07|0.91|
73854742|NCT01696968|147256185|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.95|1.0|||Poisson regression|||||1.00|0.95|
73854743|NCT01696968|147256187|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.98|1.12|||Poisson regression|||||1.12|0.98|
73854744|NCT01696968|147256191|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.91|1.07|||Poisson regression|||||1.07|0.91|
73854745|NCT01716039|147256198|OTHER|Comparing the change in the modified Baron score from baseline to week 18 between the treatment groups||||||0.758|||||||Wilcoxon (Mann-Whitney)|||||||0.758
73854746|NCT01716039|147256198|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
73904391|NCT01227564|147338842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.422|TWO_SIDED|95.0|-1.09|2.56||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||2.56|-1.09|0.4220
73904392|NCT01227564|147338842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51||||0.3728|TWO_SIDED|95.0|-24.25|9.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||9.23|-24.25|0.3728
73904393|NCT01227564|147338842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.07||||0.3452|TWO_SIDED|95.0|-25.05|8.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||8.91|-25.05|0.3452
73904394|NCT02378025|147338887|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||.25
73904395|NCT02378025|147338888|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||.08
73904396|NCT02378025|147338889|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
73904397|NCT02378025|147338890|SUPERIORITY|||||||0.25|||||||Regression, Logistic|||||||.25
73904398|NCT02378025|147338891|SUPERIORITY|||||||0.22|||||||Regression, Logistic|||||||.22
73962603|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6454|TWO_SIDED|95.0|0.87|1.25|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.25|0.87|0.6454
74088313|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.0441|TWO_SIDED|95.0|0.39|0.99|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.99|0.39|0.0441
74088314|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.17||0.1895|TWO_SIDED|95.0|0.46|1.17|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.17|0.46|0.1895
73904399|NCT02378025|147338892|SUPERIORITY|||||||0.41|||||||Regression, Logistic|||||||.41
73904400|NCT00633867|147338906|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Log Rank|||||||<0.01
73904401|NCT01857583|147338941|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|12.6|||||TWO_SIDED|95.0|-10.0|33.6|||ANCOVA|||||33.6|-10.0|
73904402|NCT01857583|147338941|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|17.3|||||TWO_SIDED|95.0|-10.2|42.1|||ANCOVA|||||42.1|-10.2|
73904403|NCT04894916|147338957|OTHER|single group|mean|81.9|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||"One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is equal to 71."||||<0.001
73904404|NCT04894916|147338960|SUPERIORITY||Mean Difference (Net)|0.73|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
73904405|NCT04894916|147338961|OTHER||Mean Difference (Net)|1.17||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
73904406|NCT04894916|147338962|OTHER|||||||0.68|||||||McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||0.68
73904407|NCT04894916|147338962|OTHER|||||||0.18|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||0.18
73904408|NCT04894916|147338962|OTHER|||||||0.18|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.18
73904409|NCT04894916|147338962|OTHER|||||||0.17|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.17
73904410|NCT04894916|147338962|OTHER|||||||0.33|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.33
73904411|NCT04894916|147338962|OTHER|||||||0.4|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.40
73904412|NCT04894916|147338962|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of flu vaccine||||1.00
73904413|NCT04894916|147338962|OTHER|||||||0.37|||||||McNemar|||Analysis of pre-post change in knowledge of recommended frequency of flu vaccination||||0.37
73904414|NCT04894916|147338963|OTHER||Mean Difference (Net)|-0.71||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
73904415|NCT04894916|147338964|OTHER|||||||0.03|||||||McNemar|||Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)||||0.03
73962604|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|0.84||||0.0561|TWO_SIDED|95.0|0.7|1.0|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.00|0.70|0.0561
73962605|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9056|TWO_SIDED|95.0|0.82|1.19|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.82|0.9056
74084977|NCT01435824|147723605|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.1|||||TWO_SIDED|90.0|97.5|115.4||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||115.4|97.5|
73854747|NCT01716039|147256199|OTHER|||||||0.908||||||p-value for the overall treatment difference is based on an analysis of covariance adjusting for baseline UCEIS|ANCOVA|||||||0.908
73854748|NCT01668628|147256201|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t-test: Comparison of baseline physical health score between Normohydration group and Overhydration group.||||0.008
73854749|NCT01668628|147256201|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline mental health score between Normohydration group and Overhydration group.||||0.008
73854750|NCT01668628|147256201|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline kidney disease component score between Normohydration group and Overhydration group||||0.008
73854751|NCT01668628|147256201|SUPERIORITY_OR_OTHER|||||||0.157|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline BDI score between Normohydration group and Overhydration group.||||0.157
73854752|NCT01519791|147256203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.283|||<|0.001|TWO_SIDED|95.0|1.503|3.468|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||3.468|1.503|<0.001
73854753|NCT01519791|147256204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.957|||<|0.001|TWO_SIDED|95.0|1.384|2.767|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||2.767|1.384|<0.001
73854754|NCT01519791|147256205|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate of shift|-0.978|||<|0.001|TWO_SIDED|95.0|-1.005|-0.5|||ANCOVA on ranks||"ANCOVA model on the ranks with the terms for treatment, region, and time since RA diagnosis at Baseline (≤4 months or \>4 months) as factors and rank Baseline value as a covariate.~Confidence Interval is an asymptotic Moses CI."|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||-0.500|-1.005|<0.001
73854755|NCT01519791|147256210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.446|||=|0.023|TWO_SIDED|95.0|1.052|1.989|||Regression, Logistic||The Odds ratio was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||1.989|1.052|=0.023
73854756|NCT01519791|147256222|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-0.177|STANDARD_ERROR_OF_MEAN|0.049|<|0.001|TWO_SIDED|95.0|-0.273|-0.082|||ANCOVA||The CfB in HAQ-DI at Week 52 was analyzed using an ANCOVA model with terms for treatment, region, and time since Rheumatoid Arthritis (RA) diagnosis at Baseline (≤4 months or \>4 months) as factors and Baseline value as a covariate.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||-0.082|-0.273|<0.001
73854757|NCT04925076|147256240|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,108)=.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X family history X sex interaction.||||.92
73904416|NCT04894916|147338964|OTHER|||||||0.45|||||||McNemar|||Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)||||0.45
73962606|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|0.9||||0.2919|TWO_SIDED|95.0|0.75|1.09|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.09|0.75|0.2919
73962607|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4976|TWO_SIDED|95.0|0.78|1.13|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.13|0.78|0.4976
73904417|NCT04894916|147338964|OTHER|||||||0.17|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me \[social comparison information\] is useful.||||0.17
73904418|NCT04894916|147338964|OTHER|||||||0.62|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range \[goal-based comparison information\] is useful.||||0.62
73904419|NCT04894916|147338966|OTHER||Mean Difference (Net)|0.09||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||0.53
73904420|NCT04894916|147338967|OTHER||Mean Difference (Net)|0.03||||0.86|TWO_SIDED||||||t-test, 2 sided|||||||0.86
73904421|NCT04894916|147338968|OTHER||Mean Difference (Net)|0.28||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
73904422|NCT04894916|147338969|OTHER||Mean Difference (Net)|0.25||||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.21
73904423|NCT04894916|147338970|OTHER||Mean Difference (Net)|-0.39||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
73962608|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|0.9||||0.2425|TWO_SIDED|95.0|0.75|1.08|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.08|0.75|0.2425
73962609|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9242|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.83|0.9242
73962610|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6621|TWO_SIDED|95.0|0.8|1.15|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.15|0.80|0.6621
73962611|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9977|TWO_SIDED|95.0|0.83|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.83|0.9977
73904424|NCT03052764|147338993|SUPERIORITY||Least Squares Mean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.561|<|0.0001|TWO_SIDED|95.0|-3.68|-1.46|||ANCOVA|||||-1.46|-3.68|<.0001
73904425|NCT03052764|147338994|SUPERIORITY||Odds Ratio (OR)|6.15|||||TWO_SIDED|95.0|0.75|50.37|||||Values obtained were from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes)at each scheduled visit.|||50.37|0.75|
73904426|NCT03052764|147338995|SUPERIORITY||Least Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|0.534|<|0.0001|TWO_SIDED|95.0|-3.3|-1.18|||ANCOVA|||||-1.18|-3.30|<.0001
73904427|NCT03052764|147338996|SUPERIORITY||Least Squares Mean Difference|-2.56|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-3.73|-1.39|||ANCOVA|||||-1.39|-3.73|<.0001
73904428|NCT03052764|147338997|SUPERIORITY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.192||0.0004|TWO_SIDED|95.0|-1.09|-0.32|||ANCOVA|||||-0.32|-1.09|0.0004
74025144|NCT03119649|147603199|SUPERIORITY||Difference in LS Means|-6.3|STANDARD_ERROR_OF_MEAN|3.76||0.0995|TWO_SIDED|95.0|-13.9|1.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||1.2|-13.9|0.0995
73904429|NCT03052764|147338998|SUPERIORITY||Odds Ratio (OR)|13.03|||||TWO_SIDED|95.0|3.23|52.57|||||Values were obtained from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) at each scheduled visit.|||52.57|3.23|
73904430|NCT04123665|147339008|SUPERIORITY||Mean Difference (Net)|-0.07|||<|0.0001|TWO_SIDED|95.0|-0.11|-0.04|||ANCOVA|Analysis of Covariance (ANCOVA) with factors for treatment group and gender, and the baseline whole mouth mean BI and whole mouth MGI as covariates.|Difference is first named treatment (experimental) minus second named treatment (control).|||-0.04|-0.11|<0.0001
73904431|NCT03880461|147339111|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
73904432|NCT03880461|147339112|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
73904433|NCT03880461|147339113|SUPERIORITY|||||||0.108|||||||ANOVA|||||||0.108
73904434|NCT02652767|147339122|SUPERIORITY||Mean Difference (Net)|-0.012||||0.889|TWO_SIDED|95.0|-0.182|0.158|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.||0.158|-0.182|0.8890
73904435|NCT03475875|147339144|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-7.7|-0.9|||Linear Mixed Model|Kenward and Roger Method was used for the Degrees of Freedom|Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||-0.9|-7.7|
73904436|NCT03475875|147339145|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|-4.7|1.0|||Linear Mixed Model|Kenward and Roger Method was used for the Degrees of Freedom|Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||1.0|-4.7|
73904437|NCT04025710|147339188|OTHER|single arm design|SADE-free rate|0.97||||0.05|TWO_SIDED|95.0|0.9|1.0|||t-test, 2 sided|||The primary hypothesis evaluates the SADE free rate (pSADE\_free) at 3 months. Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%||1|0.9|0.05
73904438|NCT02431247|147339193|NON_INFERIORITY|One-sided p-value for non-inferiority of Test versus Control arm. The non-|Difference in percentage|2.7|||<|0.001|TWO_SIDED|95.0|-1.6|7.1||inferiority margin is 10%.|Mantel Haenszel|||||7.1|-1.6|< 0.001
73904439|NCT02431247|147339196|OTHER||Least square mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.063|=|0.437|TWO_SIDED|95.0|-0.171|0.074|||ANCOVA|||||0.074|-0.171|= 0.437
73904440|NCT02431247|147339197|OTHER||LS mean difference|18.48|STANDARD_ERROR_OF_MEAN|14.808|=|0.213|TWO_SIDED|95.0|-10.595|47.55|||ANCOVA|||||47.550|-10.595|= 0.213
73904441|NCT02431247|147339198|OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.008|<|0.001|TWO_SIDED|95.0|-0.05|-0.02|||ANCOVA|||||-0.02|-0.05|< 0.001
73904442|NCT02431247|147339199|OTHER||LS mean difference|3.12|STANDARD_ERROR_OF_MEAN|0.786|<|0.001|TWO_SIDED|95.0|1.57|4.66|||ANCOVA|||||4.66|1.57|< 0.001
73962612|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9762|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.84|0.9762
73962613|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9718|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.83|0.9718
73904443|NCT02431247|147339200|OTHER||LS mean difference|6.04|STANDARD_ERROR_OF_MEAN|1.126|<|0.001|TWO_SIDED|95.0|3.83|8.25|||ANCOVA|||||8.25|3.83|< 0.001
73904444|NCT02431247|147339201|OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.747|=|0.001|TWO_SIDED|95.0|0.93|3.87|||ANCOVA|||||3.87|0.93|= 0.001
73904445|NCT02431247|147339203|OTHER||||||=|0.033|||||||Wilcoxon rank sum test|||||||= 0.033
73904446|NCT02431247|147339204|OTHER||||||=|0.033|||||||Wilcoxon rank sum test|||||||= 0.033
73904447|NCT02431247|147339205|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||< 0.001
73962614|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8219|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.85|0.8219
73904448|NCT02431247|147339206|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||< 0.001
73962615|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6936|TWO_SIDED|95.0|0.8|1.16|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.16|0.80|0.6936
73962616|NCT02528188|147460983|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5769|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.26|0.88|0.5769
73962617|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.07||0.7746|TWO_SIDED|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.89|0.7746
73962618|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.07||0.8441|TWO_SIDED|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.89|0.8441
73904449|NCT02431247|147339207|OTHER||||||=|0.147|||||||Wilcoxon rank sum test|||||||= 0.147
73904450|NCT02431247|147339212|OTHER||LS mean difference|1.95|STANDARD_ERROR_OF_MEAN|0.368|<|0.001|TWO_SIDED|95.0|1.227|2.678|||ANCOVA|||Hip region BMD (Week 24)||2.678|1.227|< 0.001
73904451|NCT02431247|147339212|OTHER||LS mean difference|2.86|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|1.934|3.791|||ANCOVA|||Hip region BMD (Week 48)||3.791|1.934|< 0.001
73904452|NCT02431247|147339212|OTHER||LS mean difference|2.09|STANDARD_ERROR_OF_MEAN|0.421|<|0.001|TWO_SIDED|95.0|1.259|2.919|||ANCOVA|||Spine region BMD (Week 24)||2.919|1.259|< 0.001
73904453|NCT02431247|147339212|OTHER||LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.588|=|0.004|TWO_SIDED|95.0|0.539|2.858|||ANCOVA|||Spine region BMD (Week 48)||2.858|0.539|= 0.004
73904454|NCT00586196|147339306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.3|||GEE|||||2.3|0.4|
73904455|NCT00586196|147339307|SUPERIORITY_OR_OTHER||Effect Size|-0.2|||||TWO_SIDED|95.0|-1.5|1.2|||GEE|||||1.2|-1.5|
73904456|NCT01476644|147339309|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Regression, Linear|||||||<0.01
73904457|NCT01484054|147339324|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|1.0|STANDARD_ERROR_OF_MEAN|2.117|||TWO_SIDED|95.0|-3.2|5.2|||Mixed Models Analysis|||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Quality of Lens Vision at 7-9 days of follow-up.||5.20|-3.20|
73962619|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.08||0.658|TWO_SIDED|95.0|0.83|1.13|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.83|0.6580
73962620|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.07||0.2279|TWO_SIDED|95.0|0.78|1.06|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.06|0.78|0.2279
73962621|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.09||0.9986|TWO_SIDED|95.0|0.84|1.18|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.18|0.84|0.9986
73854758|NCT04925076|147256240|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,108) = .01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X sex interaction.||||.92
73854759|NCT04925076|147256240|SUPERIORITY|||||||0.61|||||||Chi-squared|F(1,108) = 0.27||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X family history interaction.||||.61
73854760|NCT04925076|147256240|SUPERIORITY|||||||0.01|||||||ANOVA|F(1,108) = 6.75||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the family history X sex interaction.||||.01
73854761|NCT04925076|147256240|SUPERIORITY|||||||0.05|||||||ANOVA|F(1,108) = 3.83||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of condition.||||.05
73854762|NCT04925076|147256240|SUPERIORITY|||||||0.003|||||||ANOVA|F(1,108) = 9.53||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of family history.||||.003
73854763|NCT04925076|147256240|SUPERIORITY|||||||0.12|||||||ANOVA|F(1,108) = 2.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of sex.||||.12
73854764|NCT04925076|147256241|SUPERIORITY|||||||0.38|||||||ANOVA|F(1,107) = 0.78||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X family history X sex interaction.||||.38
73854765|NCT04925076|147256241|SUPERIORITY|||||||0.27|||||||ANOVA|F(1,107) = 0.27||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X sex interaction.||||.27
73854766|NCT04925076|147256241|SUPERIORITY|||||||0.7|||||||ANOVA|F(1,107) = 0.15||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X family history interaction.||||.70
74088315|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0567|TWO_SIDED|95.0|0.35|1.01|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.01|0.35|0.0567
73854767|NCT04925076|147256241|SUPERIORITY|||||||0.05|||||||ANOVA|F(1,107) = 3.87||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the family history X sex interaction.||||.05
73854768|NCT04925076|147256241|SUPERIORITY|||||||0.03|||||||ANOVA|F(1,107) = 5.18||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of condition.||||.03
73854769|NCT04925076|147256241|SUPERIORITY|||||||0.14|||||||ANOVA|F(1,107) = 2.24||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of family history.||||.14
73854770|NCT04925076|147256241|SUPERIORITY||||||<|0.001|||||||ANOVA|F(1,107) = 17.25||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of sex.||||<.001
73854771|NCT04925076|147256242|SUPERIORITY|||||||0.83|||||||ANOVA|F(1,107) = 0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X family history X sex interaction.||||.83
73854772|NCT04925076|147256242|SUPERIORITY|||||||0.12|||||||ANOVA|F(1,107) = 2.43||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X sex interaction.||||.12
73854773|NCT04925076|147256242|SUPERIORITY|||||||0.25|||||||ANOVA|F(1,107) = 1.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X family history interaction.||||.25
73854774|NCT04925076|147256242|SUPERIORITY|||||||0.58|||||||ANOVA|F(1,107) = 0.31||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the family history X sex interaction.||||.58
73854775|NCT04925076|147256242|SUPERIORITY|||||||0.9|||||||ANOVA|F(1,107) = 0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of condition.||||.90
73854776|NCT04925076|147256242|SUPERIORITY|||||||0.95|||||||ANOVA|F(1,107) = .004||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of family history.||||.95
73854777|NCT04925076|147256242|SUPERIORITY|||||||0.68|||||||ANOVA|F(1,107) = 0.17||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of sex.||||.68
73854778|NCT04925076|147256243|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,107) = 0.83||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X family history X sex interaction.||||.36
73962622|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.07||0.0771|TWO_SIDED|95.0|0.72|1.02|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.02|0.72|0.0771
73904458|NCT01484054|147339325|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|4.7|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-0.79|10.19|||Mixed Models Analysis|||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Lens Comfort at 7-9 days of follow-up.||10.19|-0.79|
73904459|NCT01484054|147339326|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|9.44|STANDARD_ERROR_OF_MEAN|1.829|||TWO_SIDED|95.0|5.81|13.07|||Mixed Models Analysis|||Ho: The test lens is non-inferior to the active comparator lens for Handling at 7-9 days follow-up.||13.07|5.81|
73904460|NCT04616027|147339327|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|99.67|||||TWO_SIDED|90.0|70.15|141.6||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||141.60|70.15|
73962623|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.09||0.4485|TWO_SIDED|95.0|0.77|1.13|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.77|0.4485
73962624|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.09||0.2817|TWO_SIDED|95.0|0.74|1.09|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.09|0.74|0.2817
73962625|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5426|TWO_SIDED|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.79|0.5426
73962626|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5385|TWO_SIDED|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.79|0.5385
73962627|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5041|TWO_SIDED|95.0|0.79|1.12|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.12|0.79|0.5041
73962628|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.08||0.441|TWO_SIDED|95.0|0.78|1.11|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.11|0.78|0.4410
74025145|NCT03119649|147603200|SUPERIORITY||Difference in LS Means|1.1|STANDARD_ERROR_OF_MEAN|2.11||0.594|TWO_SIDED|95.0|-3.1|5.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||5.4|-3.1|0.5940
74025146|NCT03119649|147603200|SUPERIORITY||Difference in LS Means|0.6|STANDARD_ERROR_OF_MEAN|2.06||0.7553|TWO_SIDED|95.0|-3.5|4.8||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||4.8|-3.5|0.7553
74088316|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.2||0.296|TWO_SIDED|95.0|0.44|1.28|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.28|0.44|0.2960
73904461|NCT04616027|147339327|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.34|||||TWO_SIDED|90.0|70.51|145.63||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||145.63|70.51|
73904462|NCT04616027|147339327|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|146.56|||||TWO_SIDED|90.0|103.16|208.22||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||208.22|103.16|
73904463|NCT04616027|147339327|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.31|||||TWO_SIDED|90.0|71.31|143.92||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||143.92|71.31|
73904464|NCT04616027|147339328|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|111.71|||||TWO_SIDED|90.0|79.52|156.93||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||156.93|79.52|
73904465|NCT04616027|147339328|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|120.31|||||TWO_SIDED|90.0|83.49|173.38||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||173.38|83.49|
73904466|NCT04616027|147339328|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|134.18|||||TWO_SIDED|90.0|94.46|190.62||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||190.62|94.46|
73962629|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.09||0.7426|TWO_SIDED|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.81|0.7426
73962630|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.09||0.7469|TWO_SIDED|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.81|0.7469
74025147|NCT03119649|147603200|SUPERIORITY||Difference in LS Means|1.0|STANDARD_ERROR_OF_MEAN|1.94||0.5958|TWO_SIDED|95.0|-2.9|4.9||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||4.9|-2.9|0.5958
73854779|NCT04925076|147256243|SUPERIORITY|||||||0.24|||||||ANOVA|F(1,108) = 1.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X sex interaction.||||.24
73854780|NCT04925076|147256243|SUPERIORITY|||||||0.6|||||||ANOVA|F(1,108) = 0.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X family history interaction.||||.60
73962631|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.09||0.6784|TWO_SIDED|95.0|0.81|1.15|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.15|0.81|0.6784
73962632|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.09||0.8822|TWO_SIDED|95.0|0.85|1.21|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.21|0.85|0.8822
73962633|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.09||0.9119|TWO_SIDED|95.0|0.83|1.18|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.18|0.83|0.9119
73854781|NCT04925076|147256243|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,108) = 0.00||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the family history X sex interaction.||||.99
73854782|NCT04925076|147256243|SUPERIORITY||||||<|0.001|||||||ANOVA|F(1,108) = 139.63||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of condition.||||<.001
73854783|NCT04925076|147256243|SUPERIORITY|||||||0.84|||||||ANOVA|F(1,108) = 0.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of family history.||||.84
73854784|NCT04925076|147256243|SUPERIORITY|||||||0.59|||||||ANOVA|F(1,108) = 0.30||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of sex.||||.59
73854785|NCT04925076|147256244|SUPERIORITY|||||||0.66|||||||ANOVA|F(1,93)=0.19||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.66
73854786|NCT04925076|147256244|SUPERIORITY|||||||0.41|||||||ANOVA|F(1,93)=0.69||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.41
73854787|NCT04925076|147256244|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.74||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.39
73904467|NCT04616027|147339328|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|100.99|||||TWO_SIDED|90.0|71.89|141.87||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||141.87|71.89|
73904468|NCT04616027|147339329|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|111.02|||||TWO_SIDED|90.0|79.6|154.86||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||154.86|79.60|
73904469|NCT04616027|147339329|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|116.7|||||TWO_SIDED|90.0|82.76|164.56||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||164.56|82.76|
73904470|NCT04616027|147339329|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|134.68|||||TWO_SIDED|90.0|96.56|187.85||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||187.85|96.56|
73904471|NCT04616027|147339329|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.31|||||TWO_SIDED|90.0|72.63|141.3||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||141.30|72.63|
73904472|NCT04616027|147339330|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.52|||||TWO_SIDED|90.0|88.89|115.94||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||115.94|88.89|
73904473|NCT04616027|147339330|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|110.17|||||TWO_SIDED|90.0|96.05|126.37||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||126.37|96.05|
73904474|NCT04616027|147339330|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|120.63|||||TWO_SIDED|90.0|105.63|137.77||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||137.77|105.63|
73904475|NCT04616027|147339330|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|127.06|||||TWO_SIDED|90.0|111.26|145.12||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||145.12|111.26|
73904476|NCT03737851|147339345|OTHER|a statistical test was not performed|Odds Ratio (OR)|1.202|||||TWO_SIDED|95.0|0.559|2.584||||||Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||2.584|0.559|
73904477|NCT03737851|147339345|OTHER|a statistical test was not performed|Odds Ratio (OR)|0.615|||||TWO_SIDED|95.0|0.266|1.421||||||Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||1.421|0.266|
73904478|NCT00410202|147339349|SUPERIORITY_OR_OTHER||Difference Estimate|8.9||||0.1336|TWO_SIDED|95.0|-2.0|19.9|||Hochberg procedure|||||19.9|-2.0|0.1336
74025148|NCT03119649|147603200|SUPERIORITY||Difference in LS Means|2.3|STANDARD_ERROR_OF_MEAN|1.94||0.2403|TWO_SIDED|95.0|-1.6|6.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||6.2|-1.6|0.2403
74025149|NCT03119649|147603201|SUPERIORITY||Difference in LS Means|2.7|STANDARD_ERROR_OF_MEAN|4.81||0.5749|TWO_SIDED|95.0|-6.9|12.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||12.4|-6.9|0.5749
74025150|NCT03119649|147603201|SUPERIORITY||Difference in LS Means|1.6|STANDARD_ERROR_OF_MEAN|4.83||0.7381|TWO_SIDED|95.0|-8.1|11.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||11.3|-8.1|0.7381
74025151|NCT03119649|147603201|SUPERIORITY||Difference in LS Means|6.8|STANDARD_ERROR_OF_MEAN|4.43||0.1282|TWO_SIDED|95.0|-2.0|15.7||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||15.7|-2.0|0.1282
74025152|NCT03119649|147603201|SUPERIORITY||Difference in LS Means|1.6|STANDARD_ERROR_OF_MEAN|4.43||0.7212|TWO_SIDED|95.0|-7.3|10.5||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||10.5|-7.3|0.7212
74025153|NCT03040154|147603216|SUPERIORITY||Odds Ratio (OR)|2.67||||0.006|TWO_SIDED|95.0|1.33|5.35|||Regression, Logistic|||||5.35|1.33|0.006
74025154|NCT03542682|147603219|SUPERIORITY||Mean Difference (Final Values)|-55.67|||||TWO_SIDED|95.0|-124.63|13.3|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||13.30|-124.63|
74025155|NCT03542682|147603221|SUPERIORITY||Mean Difference (Final Values)|0.96|||||TWO_SIDED|95.0|-1.1|3.02|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||3.02|-1.10|
74025156|NCT03542682|147603222|SUPERIORITY||Mean Difference (Final Values)|131.85|||||TWO_SIDED|95.0|-246.7|510.41|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||510.41|-246.70|
73854788|NCT04925076|147256244|SUPERIORITY|||||||0.22|||||||ANOVA|F(1,93)=1.54||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.22
73854789|NCT04925076|147256244|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.64||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of condition.||||.06
73854790|NCT04925076|147256244|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of family history.||||.99
73854791|NCT04925076|147256244|SUPERIORITY|||||||0.09|||||||ANOVA|F(1,93)=2.88||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of sex.||||.09
73854792|NCT04925076|147256245|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.55
73854793|NCT04925076|147256245|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,93)=0.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X sex interaction.||||.36
73854794|NCT04925076|147256245|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,93)=0.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X family history interaction.||||.36
73854795|NCT04925076|147256245|SUPERIORITY|||||||0.17|||||||ANOVA|F(1,93)=1.93||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the family history X sex interaction.||||.17
73854796|NCT04925076|147256245|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the main effect of condition.||||.55
73854797|NCT04925076|147256245|SUPERIORITY|||||||0.43|||||||ANOVA|F(1,93)=0.63||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the main effect of family history.||||.43
74025157|NCT01212445|147603223|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.192||||0.179|TWO_SIDED|95.0|0.096|0.325|||Fisher Exact|||The treatment success rate was defined as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.325|0.096|0.1790
74088317|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.65|STANDARD_ERROR_OF_MEAN|0.18||0.1215|TWO_SIDED|95.0|0.37|1.12|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.12|0.37|0.1215
73904479|NCT00410202|147339349|SUPERIORITY_OR_OTHER||Difference Estimate|5.7||||0.2619|TWO_SIDED|95.0|-4.2|15.5|||Hochberg procedure|||||15.5|-4.2|0.2619
73904480|NCT00410202|147339350|SUPERIORITY_OR_OTHER||Difference estimate|15.0||||0.0095|TWO_SIDED|95.0|3.7|26.4|||Hochberg procedure|||||26.4|3.7|0.0095
73904481|NCT00410202|147339351|SUPERIORITY_OR_OTHER||Difference Estimate|11.8|||||TWO_SIDED|95.0|2.5|21.1||||||||21.1|2.5|
73904482|NCT00410202|147339351|SUPERIORITY_OR_OTHER||Difference Estimate|8.6|||||TWO_SIDED|95.0|-1.1|18.2||||||||18.2|-1.1|
73904483|NCT00410202|147339352|SUPERIORITY_OR_OTHER||Difference estimate|12.9|||||TWO_SIDED|95.0|1.8|23.9||||||||23.9|1.8|
73904484|NCT00410202|147339353|SUPERIORITY_OR_OTHER||Difference Estimate|8.9|||||TWO_SIDED|95.0|0.3|17.4||||||||17.4|0.3|
73904485|NCT00410202|147339353|SUPERIORITY_OR_OTHER||Difference Estimate|8.6|||||TWO_SIDED|95.0|-0.1|17.3||||||||17.3|-0.1|
73904486|NCT00410202|147339354|SUPERIORITY_OR_OTHER||Difference estimate|12.9|||||TWO_SIDED|95.0|2.4|23.4||||||||23.4|2.4|
73904487|NCT00410202|147339357|SUPERIORITY_OR_OTHER||Difference Estimate|-1.26|||||TWO_SIDED|95.0|-1.534|-0.994|||Regression, Linear|||||-0.994|-1.534|
73904488|NCT00410202|147339357|SUPERIORITY_OR_OTHER||Difference Estimate|-0.55|||||TWO_SIDED|95.0|-0.824|-0.281|||Regression, Linear|||||-0.281|-0.824|
73904489|NCT00410202|147339359|SUPERIORITY_OR_OTHER||Difference Estimate|-2.4|||||TWO_SIDED|95.0|-15.5|10.7||||||||10.7|-15.5|
73904490|NCT00410202|147339359|SUPERIORITY_OR_OTHER||Difference Estimate|-1.2|||||TWO_SIDED|95.0|-15.0|12.6||||||||12.6|-15.0|
74025158|NCT01212445|147603223|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.314||||1|TWO_SIDED|95.0|0.191|0.459|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.459|0.191|1.0000
74025159|NCT01212445|147603223|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.196||||0.2558|TWO_SIDED|95.0|0.098|0.331|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.331|0.098|0.2558
73904491|NCT00410202|147339360|SUPERIORITY_OR_OTHER||Difference Estimate|-2.8|||||TWO_SIDED|95.0|-16.2|10.6||||||||10.6|-16.2|
73904492|NCT00410202|147339361|SUPERIORITY_OR_OTHER||Difference Estimate|0.8|||||TWO_SIDED|95.0|-5.2|6.7||||||||6.7|-5.2|
73904493|NCT00410202|147339361|SUPERIORITY_OR_OTHER||Difference Estimate|1.3|||||TWO_SIDED|95.0|-4.6|7.2||||||||7.2|-4.6|
73904494|NCT00410202|147339362|SUPERIORITY_OR_OTHER||Difference Estimate|-1.5|||||TWO_SIDED|95.0|-9.5|6.4||||||||6.4|-9.5|
73904495|NCT00410202|147339363|SUPERIORITY_OR_OTHER||Difference Estimate|2.2|||||TWO_SIDED|95.0|-2.4|6.8||||||||6.8|-2.4|
73904496|NCT00410202|147339363|SUPERIORITY_OR_OTHER||Difference Estimate|1.4|||||TWO_SIDED|95.0|-3.5|6.2||||||||6.2|-3.5|
73904497|NCT00410202|147339364|SUPERIORITY_OR_OTHER||Difference Estimate|2.1|||||TWO_SIDED|95.0|-3.6|7.8||||||||7.8|-3.6|
73904498|NCT00410202|147339365|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
73904499|NCT00410202|147339365|SUPERIORITY_OR_OTHER||Difference Estimate|0.0|||||TWO_SIDED|95.0|-2.0|2.0||||||||2.0|-2.0|
73904500|NCT00410202|147339367|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
73904501|NCT00410202|147339367|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
73904502|NCT01436162|147339451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.92||0.583|TWO_SIDED|95.0|-2.3|1.3|||Mixed-effects Model for Repeat Measures|||||1.3|-2.3|0.583
73904503|NCT01436162|147339452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.354|TWO_SIDED|95.0|-1.9|0.7|||Mixed-effects Model for Repeat Measures|||||0.7|-1.9|0.354
73904504|NCT05032859|147339465|SUPERIORITY||Risk Ratio, log|2.27|||<|0.0001|TWO_SIDED|95.0|1.54|3.32|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|H0: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is equal between tapinarof cream, 1% and vehicle cream; H1: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is different between the tapinarof cream, 1% and vehicle cream.||3.32|1.54|<0.0001
73904505|NCT05032859|147339466|SUPERIORITY||Risk Ratio, log|2.14|||<|0.0001|TWO_SIDED|95.0|1.53|3.0|||Cochran-Mantel-Haenszel|Stratified by vIGA-AD score at Baseline (vIGA-AD scores of 3 or 4) and age group (2-6 yrs, 7-11 yrs, 12-17 yrs, 18+ yrs)|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.00|1.53|<0.0001
73904506|NCT05032859|147339467|SUPERIORITY||Least squares mean difference|-6.6|STANDARD_ERROR_OF_MEAN|0.803|<|0.0001|TWO_SIDED|95.0|-8.17|-5.02|||ANCOVA|age\*vIGA cohort and treatment as categorical covariates, and baseline %BSA as a continuous covariate||||-5.02|-8.17|<0.0001
73904507|NCT05032859|147339468|SUPERIORITY||Risk Ratio, log|2.34||||0.0013|TWO_SIDED|95.0|1.39|3.94|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.||Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|3.94|1.39|0.0013
73904508|NCT05032859|147339469|SUPERIORITY||Risk Ratio, log|2.17||||0.0015|TWO_SIDED|95.0|1.34|3.5|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.50|1.34|0.0015
74088318|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.22||0.3569|TWO_SIDED|95.0|0.44|1.34|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.34|0.44|0.3569
73854798|NCT04925076|147256245|SUPERIORITY|||||||0.33|||||||ANOVA|F(1,93)=0.96||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of sex.||||.33
73854799|NCT04925076|147256246|SUPERIORITY|||||||0.34|||||||ANOVA|F(1,93)=0.34||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.34
73854800|NCT04925076|147256246|SUPERIORITY|||||||0.88|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.88
73854801|NCT04925076|147256246|SUPERIORITY|||||||0.56|||||||ANOVA|F(1,93)=0.34||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.56
73854802|NCT04925076|147256246|SUPERIORITY|||||||0.9|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.90
73854803|NCT04925076|147256246|SUPERIORITY|||||||0.45|||||||ANOVA|F(1,93)=0.59||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the main effect of condition.||||.45
73854804|NCT04925076|147256246|SUPERIORITY|||||||0.85|||||||ANOVA|F(1,93)=0.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the main effect of family history.||||.85
73854805|NCT04925076|147256246|SUPERIORITY|||||||0.64|||||||ANOVA|F(1,93)=0.22||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex. Here we report the results of the analysis of the main effect of sex.||||.64
73854806|NCT04925076|147256247|SUPERIORITY|||||||0.3|||||||ANOVA|F(1,93)=1.07||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.30
73854807|NCT04925076|147256247|SUPERIORITY|||||||0.11|||||||ANOVA|F(1,93)=2.62||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X sex interaction.||||.11
73854808|NCT04925076|147256247|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.76||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X family history interaction.||||.39
73854809|NCT04925076|147256247|SUPERIORITY|||||||0.89|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the family history X sex interaction.||||.89
73854810|NCT04925076|147256247|SUPERIORITY|||||||0.01|||||||ANOVA|F(1,93)=6.72||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of condition.||||.01
73854811|NCT04925076|147256247|SUPERIORITY|||||||0.08|||||||ANOVA|F(1,93)=3.15||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of family history.||||.08
73854812|NCT04925076|147256247|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.71||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of sex.||||.06
73930797|NCT01532687|147391471|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.079|||||||Gehan-Wilcoxon|||Statistical results are for the 'other' sarcoma subgroup (n = 38)||||0.079
73854813|NCT04925076|147256248|SUPERIORITY|||||||0.29|||||||ANOVA|F(1,93)=1.14||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.29
73854814|NCT04925076|147256248|SUPERIORITY|||||||0.1|||||||ANOVA|F(1,93)=2.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X sex interaction.||||.10
73854815|NCT04925076|147256248|SUPERIORITY|||||||0.49|||||||ANOVA|F(1,93)=0.47||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the condition X family history interaction.||||.49
73854816|NCT04925076|147256248|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the family history X sex interaction.||||.99
73962634|NCT02528188|147460985|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.09||0.5148|TWO_SIDED|95.0|0.89|1.26|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.26|0.89|0.5148
73904509|NCT01535664|147339470|SUPERIORITY_OR_OTHER||Difference in least square means|4.04|STANDARD_ERROR_OF_MEAN|1.51||0.015|TWO_SIDED|95.0|0.87|7.2||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment.||The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall gait was the average of WA, TW, and SQT; a higher score is indicative of better performance.||7.20|0.87|0.015
73904510|NCT01535664|147339471|SUPERIORITY_OR_OTHER||Difference in least square means|1.7|STANDARD_ERROR_OF_MEAN|0.5||0.003|TWO_SIDED|95.0|0.7|2.8|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||2.8|0.7|0.003
73904511|NCT01535664|147339472|SUPERIORITY_OR_OTHER||Difference in least square means|7.729|STANDARD_ERROR_OF_MEAN|2.495||0.006|TWO_SIDED|95.0|2.507|12.95|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||12.950|2.507|0.006
73904512|NCT01535664|147339473|SUPERIORITY_OR_OTHER||Difference in least square means|0.36|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.19|0.54|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||0.54|0.19|<.001
73904513|NCT01535664|147339474|SUPERIORITY_OR_OTHER||Difference in least square means|-2.38|STANDARD_ERROR_OF_MEAN|2.97||0.434|TWO_SIDED|95.0|-8.6|3.84||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall balance was a weighted average of SOT, LOS, and ADT.||3.84|-8.60|0.434
73904514|NCT02775903|147339499|SUPERIORITY|||||||0.1838|||||||Wald asymptotic two-sided test|||||||0.1838
73904515|NCT02775903|147339500|SUPERIORITY|||||||0.618|||||||Wald asymptotic two-sided test|||||||0.6180
73904516|NCT02775903|147339501|OTHER|P-values were not part of the formal testing.||||||0.7016|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor)||||||0.7016
73904517|NCT02775903|147339502|OTHER|P-values were not part of the formal testing.||||||0.6076|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.6076
73904518|NCT02775903|147339503|OTHER|P-values were not part of the formal testing.||||||0.384|||||||Wald asymptotic two-sided test|||||||0.3840
73904519|NCT02775903|147339504|OTHER|P-values were not part of the formal testing.||||||0.8961|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.8961
73904520|NCT02775903|147339505|OTHER|P-values were not part of the formal testing.||||||0.3591|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.3591
73904521|NCT02775903|147339506|OTHER|P-values were not part of the formal testing.||||||0.9031|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.9031
73962635|NCT02528188|147460987|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.3348|TWO_SIDED|95.0|0.66|1.15|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.15|0.66|0.3348
73904522|NCT02775903|147339508|OTHER|P-values were not part of the formal testing.||||||0.2409|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very intermediate vs poor).||||||0.2409
73904523|NCT02775903|147339509|OTHER|P-values were not part of the formal testing.||||||0.0688|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0688
73904524|NCT02775903|147339510|OTHER|P-values were not part of the formal testing.||||||0.4894|||||||Wald asymptotic two-sided test|||||||0.4894
73904525|NCT02775903|147339512|OTHER|P-values were not part of the formal testing.||||||0.0381|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0381
73904526|NCT02775903|147339514|OTHER|P-values were not part of the formal testing.||||||0.8973|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.8973
73904527|NCT02775903|147339514|OTHER|P-values were not part of the formal testing.||||||0.0691|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0691
73904528|NCT04571515|147339564|SUPERIORITY||Mean Difference (Final Values)|28.3|STANDARD_ERROR_OF_MEAN|9.25||0.003|TWO_SIDED|95.0|9.9|46.6|||Emax|||||46.6|9.9|0.003
73904529|NCT04571515|147339564|SUPERIORITY||Mean Difference (Final Values)|29.6|STANDARD_ERROR_OF_MEAN|7.94|<|0.001|TWO_SIDED|95.0|13.8|45.3|||Emax|||||45.3|13.8|<0.001
73904530|NCT04571515|147339564|SUPERIORITY||Mean Difference (Final Values)|30.3|STANDARD_ERROR_OF_MEAN|8.04|<|0.001|TWO_SIDED|95.0|14.4|46.2|||Emax|||||46.2|14.4|<0.001
73904531|NCT04571515|147339564|SUPERIORITY||Mean Difference (Final Values)|31.1|STANDARD_ERROR_OF_MEAN|8.87|<|0.001|TWO_SIDED|95.0|13.5|48.6|||Emax|||||48.6|13.5|<0.001
73962636|NCT02528188|147460987|SUPERIORITY||LS Mean Ratio|0.88|STANDARD_ERROR_OF_MEAN|0.13||0.3595|TWO_SIDED|95.0|0.66|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.66|0.3595
74025160|NCT01212445|147603223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|0.774|4.763|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence interval. There were no multiplicity adjustments."||4.763|0.774|
73854817|NCT04925076|147256248|SUPERIORITY|||||||0.13|||||||ANOVA|F(1,93)=2.29||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of condition.||||.13
73854818|NCT04925076|147256248|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of family history.||||.82
73854819|NCT04925076|147256248|SUPERIORITY|||||||0.02|||||||ANOVA|F(1,93)=6.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of sex.||||0.02
73854820|NCT04925076|147256249|SUPERIORITY|||||||0.32|||||||ANOVA|F(1,93)=1.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.32
73854821|NCT04925076|147256249|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.99
73854822|NCT04925076|147256249|SUPERIORITY|||||||0.83|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.83
73854823|NCT04925076|147256249|SUPERIORITY|||||||0.75|||||||ANOVA|F(1,93)=0.10||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.75
73854824|NCT04925076|147256249|SUPERIORITY|||||||0.62|||||||ANOVA|F(1,93)=0.25||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of condition.||||.62
73854825|NCT04925076|147256249|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,93)=0.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of family history.||||.92
73854826|NCT04925076|147256249|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.76||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of sex.||||.39
73854827|NCT04925076|147256250|SUPERIORITY|||||||0.5|||||||ANOVA|F(1,93)=0.45||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.50
73854828|NCT04925076|147256250|SUPERIORITY|||||||0.28|||||||ANOVA|F(1,93)=1.20||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X sex interaction.||||.28
73854829|NCT04925076|147256250|SUPERIORITY|||||||0.6|||||||ANOVA|F(1,93)=0.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X family history interaction.||||.60
73854830|NCT04925076|147256250|SUPERIORITY|||||||0.04|||||||ANOVA|F(1,93)=4.48||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the family history X sex interaction.||||.04
73854831|NCT04925076|147256250|SUPERIORITY|||||||0.25|||||||ANOVA|F(1,93)=1.37||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of condition.||||.25
73854832|NCT04925076|147256250|SUPERIORITY|||||||0.89|||||||ANOVA|F(1,93)=0.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of family history.||||.89
73854833|NCT04925076|147256250|SUPERIORITY|||||||0.26|||||||ANOVA|F(1,93)=1.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of sex.||||.26
73854834|NCT04925076|147256251|SUPERIORITY|||||||0.76|||||||ANOVA|F(1,93)=0.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.76
73854835|NCT04925076|147256251|SUPERIORITY|||||||0.09|||||||ANOVA|F(1,93)=3.00||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X sex interaction.||||.09
73854836|NCT04925076|147256251|SUPERIORITY|||||||0.76|||||||ANOVA|F(1,93)=0.10||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X family history interaction.||||.76
73904532|NCT04571515|147339565|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.4|1.1||||||||1.1|-1.4|
73962637|NCT02528188|147460987|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.13||0.0854|TWO_SIDED|95.0|0.54|1.04|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.04|0.54|0.0854
73962638|NCT02528188|147460987|SUPERIORITY||LS Mean Ratio|0.69|STANDARD_ERROR_OF_MEAN|0.12||0.0281|TWO_SIDED|95.0|0.5|0.96|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||0.96|0.50|0.0281
73962639|NCT02528188|147460987|SUPERIORITY||LS Mean Ratio|0.7|STANDARD_ERROR_OF_MEAN|0.13||0.0595|TWO_SIDED|95.0|0.49|1.01|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.01|0.49|0.0595
73904533|NCT04571515|147339565|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.5|0.9||||||||0.9|-1.5|
73904534|NCT04571515|147339565|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.8|0.6||||||||0.6|-1.8|
73904535|NCT04571515|147339565|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.1|1.3||||||||1.3|-1.1|
73904536|NCT04571515|147339566|SUPERIORITY||Mean Difference (Final Values)|15.2|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|7.3|23.1|||Emax|||||23.1|7.3|<0.001
73904537|NCT04571515|147339566|SUPERIORITY||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|9.3|22.9|||Emax|||||22.9|9.3|<0.001
73904538|NCT04571515|147339566|SUPERIORITY||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|9.7|23.4|||Emax|||||23.4|9.7|<0.001
73904539|NCT04571515|147339566|SUPERIORITY||Mean Difference (Final Values)|17.1|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|9.4|24.7|||Emax|||||24.7|9.4|<0.001
73904540|NCT04571515|147339567|SUPERIORITY|||||||0.208|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.208
73962640|NCT02528188|147460987|SUPERIORITY||LS Mean Ratio|0.57|STANDARD_ERROR_OF_MEAN|0.11||0.003|TWO_SIDED|95.0|0.4|0.83|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||0.83|0.40|0.0030
73962641|NCT02528188|147460987|SUPERIORITY||LS Mean Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.15||0.1389|TWO_SIDED|95.0|0.48|1.11|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.11|0.48|0.1389
74088319|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.21||0.2096|TWO_SIDED|95.0|0.36|1.25|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.25|0.36|0.2096
73962642|NCT02528188|147460987|SUPERIORITY||LS Mean Ratio|0.68|STANDARD_ERROR_OF_MEAN|0.14||0.0709|TWO_SIDED|95.0|0.45|1.03|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.03|0.45|0.0709
73962643|NCT02528188|147460996|SUPERIORITY|||||||0.6037|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.6037
73904541|NCT04571515|147339567|SUPERIORITY|||||||0.005|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.005
73904542|NCT04571515|147339567|SUPERIORITY|||||||0.192|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.192
73904543|NCT04571515|147339567|SUPERIORITY|||||||0.067|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.067
73904544|NCT04571515|147339567|SUPERIORITY|||||||0.059|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.059
73904545|NCT04571515|147339567|SUPERIORITY||||||<|0.001|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||<0.001
73904546|NCT04571515|147339567|SUPERIORITY|||||||0.017|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.017
73904547|NCT04571515|147339567|SUPERIORITY|||||||0.002|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.002
73904548|NCT04571515|147339568|SUPERIORITY|||||||0.051|||||||Regression, Logistic|||||||0.051
73904549|NCT04571515|147339568|SUPERIORITY|||||||0.035|||||||Regression, Logistic|||||||0.035
73904550|NCT04571515|147339568|SUPERIORITY|||||||0.016|||||||Regression, Logistic|||||||0.016
73904551|NCT04571515|147339568|SUPERIORITY|||||||0.18|||||||Regression, Logistic|||||||0.180
73904552|NCT04571515|147339569|SUPERIORITY|||||||0.022|||||||Wilcoxon Rank Sum|||||||0.022
73904553|NCT04571515|147339569|SUPERIORITY|||||||0.028|||||||Wilcoxon Rank Sum|||||||0.028
73904554|NCT04571515|147339569|SUPERIORITY|||||||0.007|||||||Wilcoxon Rank Sum|||||||0.007
73962644|NCT02528188|147460996|SUPERIORITY|||||||0.1928|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1928
73962645|NCT02528188|147460996|SUPERIORITY|||||||0.7204|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7204
73962646|NCT02528188|147460996|SUPERIORITY|||||||0.7969|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7969
73904555|NCT04571515|147339569|SUPERIORITY|||||||0.005|||||||Wilcoxon Rank Sum|||||||0.005
73904556|NCT01711372|147339612|OTHER||||||||||||||Chi-squared|||AUC or ROC for Groundskeeper Game|AUC of ROC is 0.78|||
73904557|NCT01711372|147339613|OTHER||||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnoses is 0.76|||
73904558|NCT01711372|147339614|OTHER|AUC of ROC|||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnosis is 0.62|||
73904559|NCT02237911|147339616|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.071|TWO_SIDED|98.3|-4.9|0.7|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.7|-4.9|0.071
73904560|NCT02237911|147339616|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.074|TWO_SIDED|98.3|-5.0|0.7|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 6 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.||0.7|-5.0|0.074
73904561|NCT02237911|147339616|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.93|TWO_SIDED|98.3|-2.7|2.9|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 3 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.||2.9|-2.7|0.930
73904562|NCT02237911|147339616|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.491|TWO_SIDED|98.3|-3.7|2.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||2.0|-3.7|0.491
73904563|NCT02237911|147339616|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.021|TWO_SIDED|98.3|-4.5|0.1|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.1|-4.5|0.021
73904564|NCT02237911|147339616|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.179|TWO_SIDED|98.3|-3.6|1.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||1.0|-3.6|0.179
73904565|NCT02237911|147339617|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.0001|TWO_SIDED|98.3|0.1|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.4|0.1|<0.0001
73904566|NCT02237911|147339617|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.012|TWO_SIDED|98.3|0.01|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.4|0.01|0.012
73962647|NCT02528188|147460996|SUPERIORITY|||||||0.7857|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7857
73904567|NCT02237911|147339617|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.005|TWO_SIDED|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|0.02|0.005
73962648|NCT02528188|147460996|SUPERIORITY|||||||0.6627|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.6627
73904568|NCT02237911|147339617|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.052|TWO_SIDED|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|-0.003|0.052
73904569|NCT02237911|147339617|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.015|TWO_SIDED|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|0.02|0.015
73904570|NCT02237911|147339617|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.489|TWO_SIDED|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|-0.003|0.489
73904571|NCT02237911|147339618|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.943|TWO_SIDED|95.0|-106.0|114.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||114|-106|0.943
73904572|NCT02237911|147339618|SUPERIORITY||Mean Difference (Final Values)|15.0||||0.814|TWO_SIDED|95.0|-112.0|142.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||142|-112|0.814
73904573|NCT02237911|147339618|SUPERIORITY||Mean Difference (Final Values)|-15.0||||0.787|TWO_SIDED|95.0|-125.0|95.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||95|-125|0.787
73904574|NCT02237911|147339618|SUPERIORITY||Mean Difference (Final Values)|-36.0||||0.581|TWO_SIDED|95.0|-164.0|92.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||92|-164|0.581
73904575|NCT02237911|147339618|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.676|TWO_SIDED|95.0|-71.0|109.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||109|-71|0.676
73904576|NCT02237911|147339618|SUPERIORITY||Mean Difference (Final Values)|51.0||||0.33|TWO_SIDED|95.0|-52.0|154.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||154|-52|0.330
73962649|NCT02528188|147460996|SUPERIORITY|||||||0.9867|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.9867
73962650|NCT02528188|147460996|SUPERIORITY|||||||0.819|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.8190
73962651|NCT02528188|147460996|SUPERIORITY|||||||0.7284|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7284
73962652|NCT02528188|147460996|SUPERIORITY|||||||0.1545|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1545
74088320|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.69|STANDARD_ERROR_OF_MEAN|0.22||0.2387|TWO_SIDED|95.0|0.37|1.28|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.28|0.37|0.2387
73904577|NCT00958789|147339634|NON_INFERIORITY|"For the primary efficacy hypothesis, H0, the total KSS change from preoperative to 2 years postoperative will be less than or equal to delta. The alternative hypothesis, Ha, will be that the total KSS change from preop to 2 years postoperative is greater than delta. When delta=63, the hypothesis will test for non-inferiority. When delta=70, the hypothesis will test for superiority.~H0: mean 2-year - mean preop less than or equal to delta. Ha: mean 2-year - mean preop greater than delta."|Mean Difference (Final Values)|70.7|||||ONE_SIDED|95.0|64.43||||||||||64.43|
73904578|NCT05007717|147339649|SUPERIORITY||Risk Ratio (RR)|1.04||||0.631|TWO_SIDED|95.0|0.89|1.2|||Mixed Models Analysis|Adjusted for ever missing a visit during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.20|0.89|0.631
73904579|NCT05007717|147339650|SUPERIORITY||Risk Ratio (RR)|0.79||||0.237|TWO_SIDED|95.0|0.54|1.16|||Mixed Models Analysis|Adjusted for ever being virally unsuppressed during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.16|0.54|0.237
73904580|NCT05007717|147339651|SUPERIORITY||Risk Ratio (RR)|0.98||||0.386|TWO_SIDED|95.0|0.94|1.02|||Mixed Models Analysis|Adjusted for always having \>80% coverage during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.02|0.94|0.386
73904581|NCT05007717|147339652|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.991|TWO_SIDED|95.0|0.71|1.41|||Regression, Cox|Adjusted for always coming to clinic by yourself.||||1.41|0.71|0.991
73904582|NCT05007717|147339653|SUPERIORITY||Risk Ratio (RR)|1.21||||0.037|TWO_SIDED|95.0|1.01|1.46|||Mixed Models Analysis|Adjusted for having been given fast track visits during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.46|1.01|0.037
73904583|NCT05007717|147339654|SUPERIORITY||Risk Ratio (RR)|1.04||||0.276|TWO_SIDED|95.0|0.97|1.12|||Mixed Models Analysis|Adjusted for having been given long intervals during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.12|0.97|0.276
73904584|NCT04824365|147339715|SUPERIORITY||Mean Difference (Final Values)|-0.3379|STANDARD_ERROR_OF_MEAN|0.1438||0.0197|TWO_SIDED|95.0|-0.6213|-0.0545|||ANOVA|two-way ANOVA||||-0.0545|-0.6213|0.0197
73904585|NCT04824365|147339716|SUPERIORITY||Mean Difference (Final Values)|0.0381|STANDARD_ERROR_OF_MEAN|0.1129||0.736|TWO_SIDED|95.0|-0.1843|0.2605|||ANOVA|Two-way ANOVA||||0.2605|-0.1843|0.736
73904586|NCT04824365|147339717|SUPERIORITY||Mean Difference (Final Values)|0.3131|STANDARD_ERROR_OF_MEAN|0.1049||0.003|TWO_SIDED|95.0|0.1069|0.5193|||ANOVA|Two-way ANOVA||||0.5193|0.1069|0.0030
73904587|NCT04824365|147339718|SUPERIORITY||Mean Difference (Final Values)|1.704|STANDARD_ERROR_OF_MEAN|0.3035|<|0.0001|TWO_SIDED|95.0|1.105|2.302|||ANOVA|Two-way ANOVA||||2.302|1.105|<0.0001
73904588|NCT04824365|147339719|SUPERIORITY||Mean Difference (Final Values)|1.633|STANDARD_ERROR_OF_MEAN|0.3362|<|0.0001|TWO_SIDED|95.0|0.9672|2.298|||ANOVA|Two-way ANOVA||||2.298|0.9672|<0.0001
73904589|NCT04824365|147339720|SUPERIORITY||Mean Difference (Final Values)|1.964|STANDARD_ERROR_OF_MEAN|0.2473|<|0.0001|TWO_SIDED|95.0|1.477|2.452|||ANOVA|Two-way ANOVA||||2.452|1.477|<0.0001
73904590|NCT04824365|147339721|SUPERIORITY||Mean Difference (Final Values)|-0.4831|STANDARD_ERROR_OF_MEAN|0.2382||0.0435|TWO_SIDED|95.0|-0.9521|-0.01413|||ANOVA|Two-way ANOVA||||-0.01413|-0.9521|0.0435
73904591|NCT04824365|147339722|SUPERIORITY||Mean Difference (Final Values)|-0.05102|STANDARD_ERROR_OF_MEAN|0.2711||0.8509|TWO_SIDED|95.0|-0.5862|0.4841|||ANOVA|Two-way ANOVA||||0.4841|-0.5862|0.8509
73904592|NCT04824365|147339723|SUPERIORITY||Mean Difference (Final Values)|0.1339|STANDARD_ERROR_OF_MEAN|0.3177||0.6738|TWO_SIDED|95.0|-0.4921|0.76|||ANOVA|Two-way ANOVA||||0.7600|-0.4921|0.6738
73904593|NCT04824365|147339724|SUPERIORITY||Mean Difference (Final Values)|0.3095|STANDARD_ERROR_OF_MEAN|0.2832||0.2753|TWO_SIDED|95.0|-0.2478|0.8669|||ANOVA|Two-way ANOVA||||0.8669|-0.2478|0.2753
73904594|NCT04824365|147339725|SUPERIORITY||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.2636|<|0.0001|TWO_SIDED|95.0|-1.948|-0.9043|||ANOVA|Two-way ANOVA||||-0.9043|-1.948|<0.0001
73904595|NCT03463031|147339733|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.001|TWO_SIDED|95.0|-0.9|-0.2|||Mixed Models Analysis|||||-0.2|-0.9|0.001
73904596|NCT03463031|147339734|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||Mixed Models Analysis|||||-0.3|-1.0|<0.001
73904597|NCT03463031|147339735|SUPERIORITY||Least Square Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|< 0.001
73904598|NCT03463031|147339736|SUPERIORITY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.233|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||||0.1|-0.6|0.233
73904599|NCT02131532|147339737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.25|STANDARD_ERROR_OF_MEAN|3.321||0.03|TWO_SIDED|95.0|1.398|17.102|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in fatigue scores between baseline and three-month assessments||17.102|1.398|0.03
73904600|NCT02131532|147339738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.625|STANDARD_ERROR_OF_MEAN|1.401||0.1|TWO_SIDED|95.0|-0.687|5.937|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in depression scores between baseline and three-month assessments||5.937|-0.687|0.10
73962653|NCT02918071|147461069|OTHER||percentage|97.4|||||TWO_SIDED|95.0|92.63|99.46|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients successfully administered benralizumab with an AI at home (Week 12)|||99.46|92.63|
73962654|NCT02918071|147461069|OTHER||Percentage|96.6|||||TWO_SIDED|95.0|91.41|99.05|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of patients who successfully administered benralizumab with an AI at home (Week 16)|||99.05|91.41|
74088321|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.71|STANDARD_ERROR_OF_MEAN|0.22||0.2627|TWO_SIDED|95.0|0.39|1.29|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.29|0.39|0.2627
73854837|NCT04925076|147256251|SUPERIORITY|||||||0.77|||||||ANOVA|F(1,93)=0.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the family history X sex interaction.||||.77
73854838|NCT04925076|147256251|SUPERIORITY|||||||0.52|||||||ANOVA|F(1,93)=0.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the main effect of condition.||||.52
73854839|NCT04925076|147256251|SUPERIORITY|||||||0.93|||||||ANOVA|F(1,93)=0.007||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain hippocampus activation. Here we report the results of the analysis of the main effect of family history.||||.93
73904601|NCT02131532|147339739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.313||0.45|TWO_SIDED|95.0|-0.991|0.491|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in independence scores between baseline and three-month assessments||0.491|-0.991|0.45
73904602|NCT02131532|147339740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.875|STANDARD_ERROR_OF_MEAN|5.03||0.03|TWO_SIDED|95.0|-25.769|-1.981|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in scores of general rating of recovery between baseline and three-month assessments||-1.981|-25.769|0.03
73904603|NCT02131532|147339741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.781|STANDARD_ERROR_OF_MEAN|5.594||0.89|TWO_SIDED|95.0|-14.01|12.448|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in physical strength scores between baseline and three-month assessments||12.448|-14.010|0.89
73904604|NCT02131532|147339742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.105|STANDARD_ERROR_OF_MEAN|2.378||0.009|TWO_SIDED|95.0|-7.729|3.519|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in memory and thinking scores between baseline and three-month assessments||3.519|-7.729|0.009
73904605|NCT02131532|147339743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.403|STANDARD_ERROR_OF_MEAN|5.168||0.009|TWO_SIDED|95.0|-30.624|-6.183|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in emotion scores between baseline and three-month assessments||-6.183|-30.624|0.009
73904606|NCT02131532|147339744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.142|STANDARD_ERROR_OF_MEAN|3.696||0.1|TWO_SIDED|95.0|-15.883|1.598|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in communication scores between baseline and three-month assessments||1.598|-15.883|0.10
73904607|NCT02131532|147339745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|1.25||0.09|TWO_SIDED|95.0|-5.455|0.455|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in daily activities scores between baseline and three-month assessments||0.455|-5.455|0.09
73904608|NCT02131532|147339746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.821|STANDARD_ERROR_OF_MEAN|1.382||0.03|TWO_SIDED|95.0|-7.091|-0.551|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in mobility scores between baseline and three-month assessments||-0.551|-7.091|0.03
73904609|NCT02131532|147339747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.875|STANDARD_ERROR_OF_MEAN|3.264||0.58|TWO_SIDED|95.0|-9.594|5.844||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in hand function scores between baseline and three-month assessments||5.844|-9.594|0.58
73904610|NCT02131532|147339748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.576|STANDARD_ERROR_OF_MEAN|3.691||0.006|TWO_SIDED|95.0|-23.304|-5.847||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in social activity scores between baseline and three-month assessments||-5.847|-23.304|0.006
73904611|NCT01466595|147339795|SUPERIORITY_OR_OTHER|||||||0.028||||||not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|no other adjustments||"Null hypothesis:~There is no difference between the two arms in the change in T-cell activation from baseline to week 4"||||0.028
73904612|NCT02117414|147339851|SUPERIORITY_OR_OTHER||Percentage|100.0|||<|0.0001|ONE_SIDED|95.0|97.75|||A priori threshold for statistical significance was 0.025.|one-proportion binomial exact test|||The alternative hypothesis is that the MRI-related event-free rate between the MRI procedure and one month post-MRI is greater than 90%. The null hypothesis will be rejected if the one-sided 97.5% lower confidence bound is greater than 90% or, equivalently, if the p-value is less than 0.025. Assuming type I error rate 0.025, even-free rate under null hypothesis 90% and true even-free rate 0.995, the minimum required sample size is 54 MRI scanned subjects in order to obtain 90% power.|||97.75|<0.0001
73904613|NCT02117414|147339852|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|1.2|||<|0.0001|ONE_SIDED|95.0|-3.8|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who experience a VPCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-3.8|<0.0001
73904614|NCT02117414|147339853|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 8%.|Difference in percentages|0.6||||0.0001|ONE_SIDED|95.0|-4.1|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a significant decrease in ventricular sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 8%.~H0: % successes MRI group ≤ % successes Control group - 8% HA: % successes MRI group \> % successes Control group - 8%"|||-4.1|0.0001
73962655|NCT02918071|147461069|OTHER||Percentage|93.1|||||TWO_SIDED|95.0|86.86|96.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 and 16)|Percentage of patients who successfully administered benralizumab with an AI at home (Week 12 and 16)|||96.98|86.86|
73962656|NCT02918071|147461070|OTHER||Percentage|97.4|||||TWO_SIDED|95.0|92.69|99.47|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients returned functional AI administered at home (Week 12)|||99.47|92.69|
73962657|NCT02918071|147461070|OTHER||Percentage|96.6|||||TWO_SIDED|95.0|91.48|99.06|||Clopper Pearson Exact CI|One sample confidence interval (Week 16)|Percentage of patients returned functional AI administered at home (Week 16)|||99.06|91.48|
73962658|NCT02918071|147461071|OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.0|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0)|Percentage of mulfunctioning AI used to administer benralizumab at home or clinic (Week 0)|||3.00|0.00|
73962659|NCT02918071|147461071|OTHER||Percentage|0.8|||||TWO_SIDED|95.0|0.02|4.52|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 4)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 4)|||4.52|0.02|
74025161|NCT01212445|147603223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.024|||||TWO_SIDED|95.0|0.386|2.72|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||2.720|0.386|
73854840|NCT04925076|147256251|SUPERIORITY|||||||0.42|||||||ANOVA|F(1,93)=0.64||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the main effect of sex.||||.42
73854841|NCT04925076|147256252|SUPERIORITY|||||||0.44|||||||ANOVA|F(1,93)=0.62||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.44
73854842|NCT04925076|147256252|SUPERIORITY|||||||0.27|||||||ANOVA|F(1,93)=1.23||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X sex interaction.||||.27
73854843|NCT04925076|147256252|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.66||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X family history interaction.||||.06
73854844|NCT04925076|147256252|SUPERIORITY|||||||0.73|||||||ANOVA|F(1,93)=0.13||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the family history X sex interaction.||||.73
73854845|NCT04925076|147256252|SUPERIORITY|||||||0.047|||||||ANOVA|F(1,93)=4.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of condition.||||.047
73854846|NCT04925076|147256252|SUPERIORITY|||||||0.97|||||||ANOVA|F(1,93)=0.001||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of family history.||||.97
73854847|NCT04925076|147256252|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of sex.||||.82
73854848|NCT04925076|147256253|SUPERIORITY|||||||0.45|||||||ANOVA|F(1,93)=0.57||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||0.45
73854849|NCT04925076|147256253|SUPERIORITY|||||||0.59|||||||ANOVA|F(1,93)=0.29||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X sex interaction.||||.59
73854850|NCT04925076|147256253|SUPERIORITY|||||||0.07|||||||ANOVA|F(1,93)=3.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X family history interaction.||||.07
73854851|NCT04925076|147256253|SUPERIORITY|||||||0.61|||||||ANOVA|F(1,93)=0.26||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the family history X sex interaction.||||.61
73854852|NCT04925076|147256253|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of condition.||||.82
73854853|NCT04925076|147256253|SUPERIORITY|||||||0.63|||||||ANOVA|F(1,93)=0.23||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of family history.||||.63
73962660|NCT02918071|147461071|OTHER||Percentage|0.8|||||TWO_SIDED|95.0|0.02|4.59|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 8)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 8)|||4.59|0.02|
73962661|NCT02918071|147461071|OTHER||Percentage|2.6|||||TWO_SIDED|95.0|0.53|7.31|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12)|||7.31|0.53|
73962662|NCT02918071|147461071|OTHER||Percentage|3.4|||||TWO_SIDED|95.0|0.94|8.52|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 16)|||8.52|0.94|
73904615|NCT02117414|147339854|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis will be rejected if the one-sided 95% log-log transformed lower confidence bound at 120 days post-implant calculated using Kaplan-Meier (K-M) method is greater than 80%.|Complication-free rate|95.9|||<|0.0001|ONE_SIDED|95.0|93.0|||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||"The system-related complication-free rate between the implant procedure and the one month post-MRI/waiting period is greater than 80%.~H0: p ≤ 0.80 HA: p \> 0.80 where p is the system-related complication-free rate between the implant procedure and 120 days (the approximate time of the one month post-MRI/waiting period visit)."|||93.0|<0.0001
73904616|NCT02117414|147339855|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|1.2|||<|1e-05|ONE_SIDED|90.0|-3.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning non-inferiority test|||"The percentage of subjects who have a defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."|||-3.1|<0.00001
73904617|NCT02117414|147339856|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%|Difference in percentages|0.0|||||TWO_SIDED|||||A priori threshold for statistical significance was 0.05. Because the success rate was 100% in each group, a p-value could not be calculated.|Farrington-Manning non-inferiority test|||"The percentage of subjects who have a SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose SVC defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."||||
73904618|NCT02117414|147339857|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|-1.3||||0.006|ONE_SIDED|90.0|-7.0||||Farrington-Manning non-inferiority test|||"The percentage of subjects who experience an APCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-7.0|0.006
73904619|NCT02117414|147339858|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|0.3||||0.005|ONE_SIDED|90.0|-6.2|||A priori threshold for statistical significance was 0.05|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a 50% decrease in atrial sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-6.2|0.005
73904620|NCT00417482|147339859|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.94||||0.02|TWO_SIDED|95.0|1.09|3.45|||Stratified Cox analysis|||The primary hypothesis of a difference in survival functions between the initial Phase B placebo (Arm 3) and risperidone continuation (Arms 1+2) conditions was tested in the primary analysis using the stratified Cox analysis. For descriptive purposes, the overall rate of relapse was assessed as the number of follow-up or for secondary interpretative support, as a simple proportion of patients entering a 16-week period.||3.45|1.09|0.02
73904621|NCT00417482|147339860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.88||||0.02|TWO_SIDED|95.0|1.08|21.98|||stratified cox analyses|||Similar analyses were used to test the secondary hypothesis in the relapse risk in weeks 17 to 32 of Phase B between the patients who continued to receive risperidone (Arm 1) \& the patients who discontinued risperidone at week 16 \& were switched to placebo (Arm 2). Patients who died \& those in whom a relapse was considered to be imminent before they were dropped out in Phase B were classified as having relapse.||21.98|1.08|0.02
73904622|NCT00417482|147339861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.36||0.08|TWO_SIDED|95.0|-0.08|1.35|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in MMSE.||1.35|-0.08|0.08
73904623|NCT00417482|147339862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.49||0.94||95.0|-1.01|0.93|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in TESS.||0.93|-1.01|0.94
73904624|NCT00417482|147339863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.48||0.26|TWO_SIDED|95.0|-1.5|0.41|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in EPS, between randomization and week 16, is zero.||0.41|-1.50|0.26
73904625|NCT00417482|147339864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.13|TWO_SIDED|95.0|-0.5|0.07|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in AIMS, between randomization and week 16, is zero.||0.07|-0.50|0.13
73904626|NCT00417482|147339865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.43||0.149|TWO_SIDED|95.0|-1.47|0.23|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in PSMS, between randomization and week 16, is zero.||0.23|-1.47|0.149
73904627|NCT00417482|147339866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.69||0.81|TWO_SIDED|95.0|-3.77|2.95|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in weight, between randomization and week 16, is zero.||2.95|-3.77|0.81
73904628|NCT05402020|147339867|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.87|1.15|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (first moderate or severe COPD exacerbations) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||1.15|0.87|
73904629|NCT05402020|147339868|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.53|0.85|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (triple therapy escalation) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||0.85|0.53|
73904630|NCT05402020|147339869|OTHER||Incidence difference|-37.9|||||TWO_SIDED|95.0|-60.1|-15.8|||||Incidence difference calculated as \[incidence rate of Tio/Olo\]-\[incidence rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||-15.8|-60.1|
73904631|NCT05402020|147339869|OTHER||Incidence Rate Ratio|0.66|||||TWO_SIDED|95.0|0.51|0.85|||||Ratio calculated as \[incidence rate of Tio/Olo\]/\[incidence rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||0.85|0.51|
73854854|NCT04925076|147256253|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of sex.||||.55
73854855|NCT04925076|147256254|SUPERIORITY|||||||0.57|||||||ANOVA|F(1,93)=0.32||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.57
73904632|NCT05402020|147339870|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.36|1.93|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (first hospitalization for community-acquired pneumonia after initiation of study drug) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||1.93|0.36|
73904633|NCT05402020|147339871|OTHER||Annualized rate ratio|0.92|||||TWO_SIDED|95.0|0.81|1.03|||||Annualized rate ratio calculated as \[annualized rate of Tio/Olo\]/\[annualized rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||1.03|0.81|
73904634|NCT05402020|147339872|OTHER||Annualized rate ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||Annualized rate ratio calculated as \[annualized rate of Tio/Olo\]/\[annualized rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||1.18|0.87|
73904635|NCT06400979|147339873|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
73904636|NCT06400979|147339874|SUPERIORITY|To assess the reduction of nausea following aromatherapy, pre- and post- aromatherapy scores were compared using paired t-tests||||||0.13|||||||ANCOVA|||||||0.13
73904637|NCT06400979|147339875|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73904638|NCT06400979|147339876|OTHER|Perceived effectiveness of aromatherapy for patient satisfaction were compared with respect to post-aromatherapy scores and pre-post changes in scores using two-sample t-tests||||||0.02|TWO_SIDED|73.4|||||t-test, 2 sided|||||||0.02
73904639|NCT06400979|147339877|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
73904640|NCT06400979|147339878|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
73904641|NCT03739840|147339879|SUPERIORITY||Percent reduction|-5.6|||=|0.687|TWO_SIDED|95.0|-38.1|19.2||Adjusted p-values are from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||19.2|-38.1|=0.687
73904642|NCT03739840|147339879|SUPERIORITY||Percent reduction|6.5|||=|0.687|TWO_SIDED|95.0|-22.7|28.7||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||28.7|-22.7|=0.687
73854856|NCT04925076|147256254|SUPERIORITY|||||||0.14|||||||ANOVA|F(1,93)=2.17||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X sex interaction.||||.14
73854857|NCT04925076|147256254|SUPERIORITY|||||||0.69|||||||ANOVA|F(1,93)=0.32||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X family history interaction.||||.69
73854858|NCT04925076|147256254|SUPERIORITY|||||||0.34|||||||ANOVA|F(1,93)=0.92||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the family history X sex interaction.||||.34
74025162|NCT01212445|147603225|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.077||||0.235|TWO_SIDED|95.0|0.021|0.185|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.185|0.021|0.2350
74025163|NCT01212445|147603225|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.157||||0.5256|TWO_SIDED|95.0|0.07|0.286|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.286|0.070|0.5256
74088322|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.22||0.2863|TWO_SIDED|95.0|0.4|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group||1.31|0.40|0.2863
73904643|NCT03739840|147339879|SUPERIORITY||Percent reduction|6.3|||=|0.687|TWO_SIDED|95.0|-22.9|28.6||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||28.6|-22.9|=0.687
73904644|NCT03739840|147339883|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.803|TWO_SIDED|95.0|0.39|3.38||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.38|0.39|=0.803
73904645|NCT03739840|147339883|SUPERIORITY||Odds Ratio (OR)|0.84|||=|0.772|TWO_SIDED|95.0|0.27|2.65||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||2.65|0.27|=0.772
73904646|NCT03739840|147339883|SUPERIORITY||Odds Ratio (OR)|1.01|||=|0.989|TWO_SIDED|95.0|0.33|3.08||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.08|0.33|=0.989
73904647|NCT03739840|147339884|SUPERIORITY||Odds Ratio (OR)|1.4|||=|0.425|TWO_SIDED|95.0|0.61|3.18||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.18|0.61|=0.425
74088323|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.27||0.556|TWO_SIDED|95.0|0.43|1.58|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.58|0.43|0.5560
73854859|NCT04925076|147256254|SUPERIORITY|||||||0.29|||||||ANOVA|F(1,93)=1.16||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of condition.||||0.29
73854860|NCT04925076|147256254|SUPERIORITY|||||||0.95|||||||ANOVA|F(1,93)=0.004||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of family history.||||.95
73854861|NCT04925076|147256254|SUPERIORITY|||||||0.11|||||||ANOVA|F(1,93)=2.65||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of sex.||||.11
73854862|NCT00967694|147256313|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Mixed Models Analysis|||A linear mixed effects model was used to assess change in IOP over time using time-points as the primary independent variable with significance set at p \< 0.05. Power calculations showed that 20 subjects would allow detection of a 2.8-mmHg difference in IOP between any two time-points with 80% power assuming a standard deviation of 3.5 mmHg for IOP and a correlation between two time- points of 0.25||||>0.05
73854863|NCT01467037|147256344|SUPERIORITY_OR_OTHER||Adjusted OR|0.088|||||TWO_SIDED|95.0|0.02|0.384|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) \*100|||0.384|0.020|
73854864|NCT01467037|147256344|SUPERIORITY_OR_OTHER||Adjusted OR|0.075|||||TWO_SIDED|95.0|0.018|0.307|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) \*100|||0.307|0.018|
73854865|NCT00939029|147256368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.05|TWO_SIDED|90.0|1.0|7.5||1 tailed p-value|Regression, Logistic|||||7.5|1.0|0.05
73854866|NCT00939029|147256369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.014|TWO_SIDED|90.0|1.4|11.6||1 tailed|Regression, Logistic|||||11.6|1.4|0.014
73854867|NCT00939029|147256370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.087|TWO_SIDED|90.0|0.8|6.0||1 tailed|Regression, Logistic|||||6.0|0.8|0.087
73854868|NCT00344318|147256448|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 1 was computed.|Difference in percentage|2.17|||||TWO_SIDED|95.0|-1.51|4.88||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||4.88|-1.51|
74025164|NCT01212445|147603225|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.118||||0.7746|TWO_SIDED|95.0|0.044|0.239|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.239|0.044|0.7746
74025165|NCT01212445|147603225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.233|||||TWO_SIDED|95.0|0.628|7.94|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||7.940|0.628|
74025166|NCT01212445|147603225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.424|6.043|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||6.043|0.424|
74025167|NCT01212445|147603226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.752||||0.1876|TWO_SIDED|95.0|-3.834|19.338|||ANCOVA|||||19.338|-3.834|0.1876
74025168|NCT01212445|147603226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.706||||0.768|TWO_SIDED|95.0|-9.729|13.141|||ANCOVA|||||13.141|-9.729|0.7680
74088324|NCT02709486|147730014|SUPERIORITY||LS Mean Ratio|0.8|STANDARD_ERROR_OF_MEAN|0.26||0.5076|TWO_SIDED|95.0|0.42|1.53|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.53|0.42|0.5076
73854869|NCT00344318|147256448|NON_INFERIORITY_OR_EQUIVALENCE|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 2 was computed|Difference in percentage|-1.48||||||95.0|-6.05|1.92||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||1.92|-6.05|
73854870|NCT00344318|147256448|NON_INFERIORITY_OR_EQUIVALENCE|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 3 was computed.|Difference in percentage|3.05|||||TWO_SIDED|95.0|-1.02|6.19||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||6.19|-1.02|
73854871|NCT00344318|147256448|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C across doses was computed.|Difference in percentage|3.13|||||TWO_SIDED|95.0|-2.65|8.01||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||8.01|-2.65|
73854872|NCT06359028|147256495|SUPERIORITY||Adjusted Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-2.16|-1.72|||Mixed Model with Repeated Measures|||||-1.72|-2.16|<0.0001
73854873|NCT06359028|147256496|SUPERIORITY||Adjusted Mean Difference|57.37|STANDARD_ERROR_OF_MEAN|3.599|<|0.0001|TWO_SIDED|95.0|50.23|64.51|||Mixed Model with Repeated Measures|||||64.51|50.23|<0.0001
73854874|NCT06359028|147256497|SUPERIORITY||Adjusted Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.121|<|0.0001|TWO_SIDED|95.0|-1.89|-1.41|||Mixed Model with Repeated Measures|||||-1.41|-1.89|<0.0001
73854875|NCT06359028|147256498|SUPERIORITY||Adjusted Mean Difference|35.37|STANDARD_ERROR_OF_MEAN|4.28|<|0.0001|TWO_SIDED|95.0|26.88|43.86|||Mixed Model with Repeated Measures|||||43.86|26.88|<0.0001
74025169|NCT01212445|147603226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.046||||0.2941|TWO_SIDED|95.0|-17.412|5.32|||ANCOVA|||||5.320|-17.412|0.2941
73854876|NCT06359028|147256499|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.296||0.1268|TWO_SIDED|95.0|-1.04|0.13|||Mixed Model with Repeated Measures|||Q7, Day 28||0.13|-1.04|0.1268
73854877|NCT06359028|147256499|SUPERIORITY||Adjusted Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.316|<|0.0001|TWO_SIDED|95.0|-2.38|-1.13|||Mixed Model with Repeated Measures|||Q7, Day 56||-1.13|-2.38|<0.0001
73854878|NCT06359028|147256499|SUPERIORITY||Adjusted Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.315||0.0245|TWO_SIDED|95.0|-1.35|-0.09|||Mixed Model with Repeated Measures|||Q8, Day 28||-0.09|-1.35|0.0245
73854879|NCT06359028|147256499|SUPERIORITY||Adjusted Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.318|<|0.0001|TWO_SIDED|95.0|-2.44|-1.18|||Mixed Model with Repeated Measures|||Q8, Day 56||-1.18|-2.44|<0.0001
73854880|NCT06359028|147256499|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.337||0.3851|TWO_SIDED|95.0|-0.96|0.37|||Mixed Model with Repeated Measures|||Q9, Day 28||0.37|-0.96|0.3851
73904648|NCT03739840|147339884|SUPERIORITY||Odds Ratio (OR)|1.23|||=|0.625|TWO_SIDED|95.0|0.53|2.85||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate||2.85|0.53|=0.625
73962663|NCT02918071|147461071|OTHER||Percentage|0.6|||||TWO_SIDED|95.0|0.07|1.99|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 8)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 8)|||1.99|0.07|
73904649|NCT03739840|147339884|SUPERIORITY||Odds Ratio (OR)|1.9|||=|0.125|TWO_SIDED|95.0|0.84|4.34||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate||4.34|0.84|=0.125
73904650|NCT03739840|147339885|SUPERIORITY||Median Difference (Final Values)|3.25|||=|0.737|TWO_SIDED|95.0|-17.08|20.36||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||20.36|-17.08|=0.737
73904651|NCT03739840|147339885|SUPERIORITY||Median Difference (Net)|6.17|||=|0.458|TWO_SIDED|95.0|-10.0|21.91||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||21.91|-10.00|=0.458
73904652|NCT03739840|147339885|SUPERIORITY||Median Difference (Net)|9.31|||=|0.341|TWO_SIDED|95.0|-10.92|28.21||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||28.21|-10.92|=0.341
73904653|NCT01058265|147339887|SUPERIORITY_OR_OTHER|||||||0.487||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in PCS between two groups.||||0.487
73904654|NCT01058265|147339888|SUPERIORITY_OR_OTHER|||||||0.817||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in MCS between two groups.||||0.817
73904655|NCT02869438|147339889|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.0707|TWO_SIDED|95.0|-0.007|0.161|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28|||0.161|-0.007|0.0707
73904656|NCT02869438|147339889|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.7747|TWO_SIDED|95.0|-0.077|0.104|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56|||0.104|-0.077|0.7747
73904657|NCT02869438|147339889|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.0969|TWO_SIDED|95.0|-0.014|0.173|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84|||0.173|-0.014|0.0969
73904658|NCT02869438|147339889|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.1558|TWO_SIDED|95.0|-0.022|0.135|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For average over Day 28, 56, and 84|||0.135|-0.022|0.1558
73904659|NCT02869438|147339890|SUPERIORITY||Mean Difference (Final Values)|-0.176||||0.2847|TWO_SIDED|95.0|-0.505|0.153|||Mixed Models Analysis|Model includes covariates of treatment, baseline RV, region, visit, treatment by visit interaction.||||0.153|-0.505|0.2847
73904660|NCT02869438|147339891|SUPERIORITY||Mean Difference (Final Values)|-101.0|||<|0.0001|TWO_SIDED|95.0|-118.9|-83.06|||Mixed Models Analysis|Model includes covariates of treatment, baseline eosinophils counts, region, visit, treatment by visit interaction.||||-83.06|-118.9|<0.0001
73904661|NCT02869438|147339892|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.6384|TWO_SIDED|95.0|-0.049|0.08|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3|||0.08|-0.049|0.6384
73904662|NCT02869438|147339892|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.148|TWO_SIDED|95.0|-0.016|0.109|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7|||0.109|-0.016|0.148
73904663|NCT02869438|147339892|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.4959|TWO_SIDED|95.0|-0.049|0.101|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14|||0.101|-0.049|0.4959
73904664|NCT02869438|147339893|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.8667|TWO_SIDED|95.0|-0.062|0.073|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 3|||0.073|-0.062|0.8667
73904665|NCT02869438|147339893|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.2734|TWO_SIDED|95.0|-0.033|0.115|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 7|||0.115|-0.033|0.2734
73904666|NCT02869438|147339893|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.7252|TWO_SIDED|95.0|-0.068|0.098|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 14|||0.098|-0.068|0.7252
73904667|NCT02869438|147339893|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.0976|TWO_SIDED|95.0|-0.014|0.164|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 28|||0.164|-0.014|0.0976
73904668|NCT02869438|147339893|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.6536|TWO_SIDED|95.0|-0.077|0.122|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 56|||0.122|-0.077|0.6536
73904669|NCT02869438|147339893|SUPERIORITY||Mean Difference (Final Values)|0.092||||0.0595|TWO_SIDED|95.0|-0.004|0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 84|||0.188|-0.004|0.0595
73904670|NCT02869438|147339893|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.1377|TWO_SIDED|95.0|-0.02|0.147|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||0.147|-0.02|0.1377
73904671|NCT02869438|147339894|SUPERIORITY||Odds Ratio (OR)|1.49||||0.1604|TWO_SIDED|95.0|0.85|2.58|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3|||2.58|0.85|0.1604
73904672|NCT02869438|147339894|SUPERIORITY||Odds Ratio (OR)|1.29||||0.34|TWO_SIDED|95.0|0.76|2.19|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7|||2.19|0.76|0.3400
73904673|NCT02869438|147339894|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0924|TWO_SIDED|95.0|0.93|2.7|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14|||2.70|0.93|0.0924
73904674|NCT02869438|147339894|SUPERIORITY||Odds Ratio (OR)|1.57||||0.1052|TWO_SIDED|95.0|0.91|2.71|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28|||2.71|0.91|0.1052
73904675|NCT02869438|147339894|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3271|TWO_SIDED|95.0|0.77|2.21|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56|||2.21|0.77|0.3271
73904676|NCT02869438|147339894|SUPERIORITY||Odds Ratio (OR)|1.33||||0.3017|TWO_SIDED|95.0|0.77|2.29|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84|||2.29|0.77|0.3017
73904677|NCT02869438|147339895|SUPERIORITY||Mean Difference (Final Values)|-0.293||||0.0024|TWO_SIDED|95.0|-0.481|-0.105|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 14|||-0.105|-0.481|0.0024
73904678|NCT02869438|147339895|SUPERIORITY||Mean Difference (Final Values)|-0.402||||0.0002|TWO_SIDED|95.0|-0.609|-0.195|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 28|||-0.195|-0.609|0.0002
73904679|NCT02869438|147339895|SUPERIORITY||Mean Difference (Final Values)|-0.312||||0.0117|TWO_SIDED|95.0|-0.554|-0.07|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 56|||-0.07|-0.554|0.0117
73904680|NCT02869438|147339895|SUPERIORITY||Mean Difference (Final Values)|-0.472||||0.0004|TWO_SIDED|95.0|-0.731|-0.213|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 84|||-0.213|-0.731|0.0004
73904681|NCT02869438|147339895|SUPERIORITY||Mean Difference (Final Values)|-0.395||||0.0002|TWO_SIDED|95.0|-0.603|-0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||-0.188|-0.603|0.0002
73904682|NCT02869438|147339896|SUPERIORITY||Mean Difference (Final Values)|-7.229||||0.0001|TWO_SIDED|95.0|-10.832|-3.626|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 28|||-3.626|-10.832|0.0001
73904683|NCT02869438|147339896|SUPERIORITY||Mean Difference (Final Values)|-5.942||||0.0115|TWO_SIDED|95.0|-10.538|-1.346|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 56|||-1.346|-10.538|0.0115
73904684|NCT02869438|147339896|SUPERIORITY||Mean Difference (Final Values)|-8.599||||0.0004|TWO_SIDED|95.0|-13.3|-3.898|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 84|||-3.898|-13.3|0.0004
73904685|NCT02869438|147339896|SUPERIORITY||Mean Difference (Final Values)|-7.257||||0.0003|TWO_SIDED|95.0|-11.133|-3.38|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||-3.38|-11.133|0.0003
73904686|NCT02869438|147339897|SUPERIORITY||Mean Difference (Final Values)|5.414||||0.2825|TWO_SIDED|95.0|-4.492|15.321|||Mixed Models Analysis|Model includes covariates of treatment, baseline FeNO value, region, visit, treatment by visit interaction.||||15.321|-4.492|0.2825
73904687|NCT02869438|147339907|SUPERIORITY||Mean Difference (Final Values)|-0.365||||0.012|TWO_SIDED|95.0|-0.649|-0.081|||Mixed Models Analysis|Model includes covariates of treatment, baseline PGI-S score, region, visit, treatment by visit interaction.|For Day 84|||-0.081|-0.649|0.0120
73904688|NCT02869438|147339908|SUPERIORITY||Odds Ratio (OR)|2.97||||0.0018|TWO_SIDED|95.0|1.5|5.88|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.||5.88|1.50|0.0018
73904689|NCT02869438|147339909|SUPERIORITY||Odds Ratio (OR)|2.51||||0.0107|TWO_SIDED|95.0|1.24|5.09|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.||5.09|1.24|0.0107
73904690|NCT02343081|147339912|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the ratio of the mean for Cmax for Temozolomide reference and test to fall within the 80-125% confidence range.|Cmax|94.37|||<|0.05|TWO_SIDED|90.0|82.69|107.69|||ANOVA|Primary parameters were analyzed using ANOVA. A linear, mixed model for crossover designs (two-period, two-sequence, two-treatment) was used.|Cmax Test/Reference Ratio|Bioequivalence assessment was made for the 90% CI for the ratio of log transformed pharmacokinetic parameters μT / μR and with the two one-sided Schuirmann T-test procedure under the null hypothesis||107.69|82.69|<0.05
73904691|NCT02343081|147339916|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-t for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-t|100.99|||<|0.05|TWO_SIDED|90.0|97.81|104.28|||ANOVA||AUC0-t Test/Reference Ratio|||104.28|97.81|<0.05
73904692|NCT02343081|147339917|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-inf for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-inf|101.53|||<|0.05|TWO_SIDED|90.0|98.6|104.54|||ANOVA||AUC0-inf Test/Reference Ratio|||104.54|98.60|<0.05
73904693|NCT02169284|147339918|OTHER|||||||0.208|||||||Wilcoxon rank-sum test|||Nucleus P-EGFR in benign tissue between erlotinib and placebo||||0.208
73904694|NCT02169284|147339918|OTHER|||||||0.208|||||||Wilcoxon rank-sum test|||Cytoplasm P-EGFR in benign tissue between erlotinib and placebo||||0.208
73904695|NCT02169284|147339918|OTHER|||||||0.272|||||||Wilcoxon rank-sum test|||Membrane P-EGFR in benign tissue between erlotinib and placebo||||0.272
73904696|NCT02169284|147339918|OTHER|||||||0.22|||||||Wilcoxon rank-sum test|||Entire Cell P-EGFR in benign tissue between erlotinib and placebo||||0.220
73854881|NCT06359028|147256499|SUPERIORITY||Adjusted Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.375||0.0002|TWO_SIDED|95.0|-2.22|-0.73|||Mixed Model with Repeated Measures|||Q9, Day 56||-0.73|-2.22|0.0002
73904697|NCT02169284|147339919|OTHER|||||||0.361|||||||Wilcoxon rank-sum test|||Nucleus P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.361
73904698|NCT02169284|147339919|OTHER|||||||0.383|||||||Wilcoxon rank-sum test|||Cytoplasm P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.383
73904699|NCT02169284|147339919|OTHER|||||||0.427|||||||Wilcoxon rank-sum test|||Membrane P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.427
73904700|NCT02169284|147339919|OTHER|||||||0.416|||||||Wilcoxon rank-sum test|||Entire Cell P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.416
73854882|NCT06359028|147256500|SUPERIORITY||Adjusted Mean Difference|-6.19|STANDARD_ERROR_OF_MEAN|4.674||0.1884|TWO_SIDED|95.0|-15.46|3.08|||Mixed Model with Repeated Measures|||Day 28||3.08|-15.46|0.1884
73854883|NCT06359028|147256500|SUPERIORITY||Adjusted Mean Difference|-24.49|STANDARD_ERROR_OF_MEAN|6.308||0.0002|TWO_SIDED|95.0|-37.0|-11.97|||Mixed Model with Repeated Measures|||Day 56||-11.97|-37.00|0.0002
73854884|NCT06359028|147256501|SUPERIORITY||Adjusted Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.774||0.3003|TWO_SIDED|95.0|-2.34|0.73|||Mixed Model with Repeated Measures|||Day 28||0.73|-2.34|0.3003
73854885|NCT06359028|147256501|SUPERIORITY||Adjusted Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|0.903||0.0028|TWO_SIDED|95.0|-4.56|-0.97|||Mixed Model with Repeated Measures|||Day 56||-0.97|-4.56|0.0028
73854886|NCT06359028|147256502|SUPERIORITY||Adjusted Mean Difference|-3.78|STANDARD_ERROR_OF_MEAN|2.127||0.0784|TWO_SIDED|95.0|-8.0|0.44|||Mixed Model with Repeated Measures|||Day 28||0.44|-8.00|0.0784
73854887|NCT06359028|147256502|SUPERIORITY||Adjusted Mean Difference|-8.17|STANDARD_ERROR_OF_MEAN|3.074||0.0092|TWO_SIDED|95.0|-14.27|-2.07|||Mixed Model with Repeated Measures|||Day 56||-2.07|-14.27|0.0092
73854888|NCT06359028|147256503|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.846||0.8686|TWO_SIDED|95.0|-1.82|1.54|||Mixed Model with Repeated Measures|||Day 28||1.54|-1.82|0.8686
73854889|NCT06359028|147256503|SUPERIORITY||Adjusted Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|0.976||0.0012|TWO_SIDED|95.0|-5.18|-1.31|||Mixed Model with Repeated Measures|||Day 56||-1.31|-5.18|0.0012
73854890|NCT06359028|147256504|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|1.444||0.9047|TWO_SIDED|95.0|-3.04|2.69|||Mixed Model with Repeated Measures|||Day 28||2.69|-3.04|0.9047
73854891|NCT06359028|147256504|SUPERIORITY||Adjusted Mean Difference|-6.66|STANDARD_ERROR_OF_MEAN|1.656||0.0001|TWO_SIDED|95.0|-9.95|-3.38|||Mixed Model with Repeated Measures|||Day 56||-3.38|-9.95|0.0001
73854892|NCT06359028|147256505|SUPERIORITY||Adjusted Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.84||0.5733|TWO_SIDED|95.0|-2.14|1.19|||Mixed Model with Repeated Measures|||Day 28||1.19|-2.14|0.5733
73854893|NCT06359028|147256505|SUPERIORITY||Adjusted Mean Difference|-2.88|STANDARD_ERROR_OF_MEAN|1.026||0.006|TWO_SIDED|95.0|-4.92|-0.84|||Mixed Model with Repeated Measures|||Day 56||-0.84|-4.92|0.0060
73854894|NCT06359028|147256506|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.127||0.2768|TWO_SIDED|95.0|-0.39|0.11|||Mixed Model with Repeated Measures|||Day 28||0.11|-0.39|0.2768
73854895|NCT06359028|147256506|SUPERIORITY||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.113||0.0232|TWO_SIDED|95.0|-0.48|-0.04|||Mixed Model with Repeated Measures|||Day 56||-0.04|-0.48|0.0232
73854896|NCT06359028|147256507|SUPERIORITY||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.403||0.8996|TWO_SIDED|95.0|-0.75|0.85|||Mixed Model with Repeated Measures|||Day 28||0.85|-0.75|0.8996
73854897|NCT06359028|147256507|SUPERIORITY||Adjusted Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.383||0.0204|TWO_SIDED|95.0|-1.66|-0.14|||Mixed Model with Repeated Measures|||Day 56||-0.14|-1.66|0.0204
73854898|NCT01866111|147256529|SUPERIORITY||||||<|0.001|||||||ANCOVA|||A step down procedure was used for the primary efficacy analyses to ensure the type one error rate for multiple comparisons was controlled at the 5% level using the following hierarchy: 200 mg vs placebo, 400 mg vs placebo, 100 mg vs placebo, in which a statistically significant difference had to be detected in this order for each subsequent comparison to occur.||||<0.001
73854899|NCT01866111|147256529|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73854900|NCT01866111|147256529|SUPERIORITY|||||||0.007|||||||ANCOVA|||||||0.007
73854901|NCT01866111|147256530|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73854902|NCT01866111|147256530|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73854903|NCT01866111|147256530|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
73854904|NCT04113018|147256580|SUPERIORITY||Response rate|0.5385||||0.375|TWO_SIDED|95.0|0.3718|0.6991|||Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|A minimax 2-stage design was used to test the hypothesis that the CR+ rate less than or equal to 50%. Twenty-three evaluable subjects were enrolled in the first stage, followed by an additional 16 subjects for a total of 39 subjects. This design provided 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. If at least 24 of 39 participants had achieved CR or better to induction, the null hypothesis would have been rejected.||0.6991|0.3718|0.375
73854905|NCT04113018|147256587|OTHER|Estimation only|Rate|0.0513|||||TWO_SIDED|95.0|0.0063|0.1732|||||Confidence interval estimated using the Clopper Pearson method.|||0.1732|0.0063|
73854906|NCT04113018|147256588|OTHER|Estimation only.|Rate|0.0256|||||TWO_SIDED|95.0|0.0006|0.1348|||||Confidence interval estimated using the Clopper Pearson method.|||0.1348|0.0006|
73854907|NCT02791516|147256613|SUPERIORITY||LS Mean Difference|9.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|7.6|11.5|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||11.5|7.6|<0.001
73854908|NCT02791516|147256614|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|1.4|3.7|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||3.7|1.4|<0.001
73854909|NCT02791516|147256615|SUPERIORITY||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.7||0.004|TWO_SIDED|95.0|0.7|3.6|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||3.6|0.7|0.004
73854910|NCT04091581|147256646|OTHER|||||||0.002|||||||ANOVA|||||||0.002
73854911|NCT04091581|147256646|OTHER|||||||0.022|||||||t-test, 2 sided|||Comparison of the baseline tear evaporation rate of the non-dry eye and dry eye group.||||0.022
74025170|NCT01212445|147603227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.302||||0.8109|TWO_SIDED|95.0|-12.059|9.454|||ANCOVA|||||9.454|-12.059|0.8109
74025171|NCT01212445|147603227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.075||||0.6995|TWO_SIDED|95.0|-12.693|8.544|||ANCOVA|||||8.544|-12.693|0.6995
73904701|NCT02169284|147339920|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Baseline visit - p-value between erlotinib and placebo arms||||1.000
73904702|NCT02169284|147339920|OTHER|||||||0.199|||||||Wilcoxon rank-sum test|||Day 8 - p-value between erlotinib and placebo arms||||0.199
73904703|NCT02169284|147339920|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Surgery visit - p-value between erlotinib and placebo arms||||<0.001
73904704|NCT02169284|147339921|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Baseline visit - p-value between erlotinib and placebo arms||||1.000
73904705|NCT02169284|147339921|OTHER|||||||0.288|||||||Wilcoxon rank-sum test|||Day 8 - p-value between erlotinib and placebo arms||||0.288
73904706|NCT02169284|147339921|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Surgery visit - p-value between erlotinib and placebo arms||||<0.001
73904707|NCT02169284|147339922|OTHER|||||||0.792|||||||Wilcoxon rank-sum test|||P-value between groups at Baseline||||0.792
74088325|NCT02377921|147730033|SUPERIORITY||Least Squares (LS) Mean Difference|0.74||||0.5387|TWO_SIDED|95.0|-1.61|3.09||Generalized estimating equation (GEE) model includes change from Baseline (BL) as dependent variable, visit, treatment and visit by treatment as fixed factors, and BL values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||3.09|-1.61|0.5387
73904708|NCT02169284|147339922|OTHER|||||||0.261|||||||Wilcoxon rank-sum test|||P-value between groups at surgery visit||||0.261
73904709|NCT02169284|147339923|OTHER|||||||0.721|||||||Wilcoxon rank-sum test|||Expression of e-cadherin in Benign Tissue, P-Value between arms||||0.721
73904710|NCT02169284|147339923|OTHER|||||||0.108|||||||Wilcoxon rank-sum test|||Expression of e-cadherin in Tumor Tissue, P-Value between arms||||0.108
73904711|NCT02169284|147339924|OTHER|||||||0.444|||||||Wilcoxon rank-sum test|||Expression of KI-67 in Benign Tissue, P-Value between arms||||0.444
73904712|NCT02169284|147339924|OTHER|||||||0.663|||||||Wilcoxon rank-sum test|||Expression of KI-67 in Tumor Tissue, P-Value between arms||||0.663
73904713|NCT02169284|147339925|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Difference in p-ERK between Normal and Tumor Tissue, P-Value between arms||||1.000
73904714|NCT02169284|147339925|OTHER|||||||0.792|||||||Wilcoxon rank-sum test|||Difference in Cytoplasm p-ERK between Normal and Tumor Tissue, P-Value between arms||||0.792
74025172|NCT01212445|147603227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.772||||0.885|TWO_SIDED|95.0|-11.329|9.784|||ANCOVA|||||9.784|-11.329|0.8850
73904715|NCT02169284|147339925|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Difference in Entire Cell p-ERK between Normal and Tumor Tissue, p-value between arms||||1.000
73904716|NCT02169284|147339926|OTHER|||||||0.772|||||||Wilcoxon rank-sum test|||||||0.772
73904717|NCT03583073|147339930|SUPERIORITY|||||||0.053|||||||Chi-squared, Corrected|DF = 1||||||.053
73904718|NCT03583073|147339931|SUPERIORITY||Mean Difference (Final Values)|1.94||||0.072|TWO_SIDED|95.0|-0.18|4.06|||Chi-squared, Corrected|||||4.06|-0.18|.072
73904719|NCT01367119|147339932|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.||||0.171
73904720|NCT01367119|147339933|SUPERIORITY_OR_OTHER|||||||0.258||95.0|||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.||||0.258
73904721|NCT01367119|147339934|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||t-test, 2 sided|||Comparison between groups for nausea||||0.091
73904722|NCT01367119|147339934|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||t-test, 2 sided|||Comparison between groups for headache||||0.763
73904723|NCT01367119|147339934|SUPERIORITY_OR_OTHER|||||||0.356||95.0|||||t-test, 2 sided|||Comparison between groups for myalgia||||0.356
73904724|NCT01367119|147339934|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||t-test, 2 sided|||Comparison between groups for visual disturbance||||0.093
73904725|NCT01367119|147339934|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||Comparison between groups for confusion||||0.003
73904726|NCT01367119|147339934|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||Comparison between groups for recovery room agitation||||0.860
73904727|NCT03180684|147339935|SUPERIORITY|||||||0.0071|||||||Clopper Pearson|A 1-sided p-value was calculated to prove superiority over historical control of 2%. Superiority of VGX-3100 alone was declared if p-value is \<0.025.||||||0.0071
73904728|NCT03180684|147339935|SUPERIORITY|||||||0.0004|||||||Clopper Pearson|1-sided p-value was calculated to prove superiority over historical control of 2%.Superiority of VGX-3100+imiquimod was declared if p-value is \<0.025.||||||0.0004
73904729|NCT02675231|147339947|SUPERIORITY|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.0506|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) \>3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.||||0.0506
73904730|NCT02675231|147339947|SUPERIORITY|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.7695|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) \>3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.||||0.7695
74025173|NCT01212445|147603228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.886||||0.0486|TWO_SIDED|95.0|0.078|25.695|||ANCOVA|||||25.695|0.078|0.0486
74025174|NCT01212445|147603228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.245||||0.8465|TWO_SIDED|95.0|-11.471|13.962|||ANCOVA|||||13.962|-11.471|0.8465
74025175|NCT01212445|147603228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.641||||0.0744|TWO_SIDED|95.0|-24.449|1.167|||ANCOVA|||||1.167|-24.449|0.0744
73904731|NCT02675231|147339948|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.241|TWO_SIDED|95.0|0.36|1.3|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.30|0.36|0.241
73904732|NCT02675231|147339948|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.313|TWO_SIDED|95.0|0.38|1.36|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.36|0.38|0.313
73904733|NCT02675231|147339949|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104|TWO_SIDED|95.0|0.42|1.08|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.08|0.42|0.104
73904734|NCT02675231|147339949|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.12|TWO_SIDED|95.0|0.43|1.1|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.10|0.43|0.120
73904735|NCT02675231|147339950|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.049|TWO_SIDED|95.0|0.42|1.0|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.00|0.42|0.049
73904736|NCT02675231|147339950|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.153|TWO_SIDED|95.0|0.48|1.12|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.12|0.48|0.153
73904737|NCT02675231|147339955|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.232|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.232
73904738|NCT02675231|147339956|SUPERIORITY||Least Square (LS) Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|2.4||0.689|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Global health status||||0.689
73904739|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.3||0.141|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scales: Physical functioning||||0.141
73904740|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.3||0.095|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Role functioning||||0.095
73904741|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.5||0.591|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Emotional functioning||||0.591
73904742|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|2.1||0.935|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Cognitive functioning||||0.935
73904743|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|2.7||0.578|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Social functioning||||0.578
73904744|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.8||0.308|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Fatigue||||0.308
74025176|NCT01212445|147603229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.4591|TWO_SIDED|95.0|-6.153|13.534|||ANCOVA|||||13.534|-6.153|0.4591
74025177|NCT01212445|147603229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.887||||0.5546|TWO_SIDED|95.0|-6.765|12.539|||ANCOVA|||||12.539|-6.765|0.5546
73904745|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|2.0||0.043|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Nausea and vomiting||||0.043
73904746|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|3.0||0.026|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Pain||||0.026
73904747|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.8||0.276|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Dyspnoea||||0.276
73904748|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|3.1||0.041|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Insomnia||||0.041
73904749|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|3.4||0.262|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Appetite loss||||0.262
73904750|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.7||0.285|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Constipation||||0.285
74025178|NCT01212445|147603229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.803||||0.8685|TWO_SIDED|95.0|-10.397|8.79|||ANCOVA|||||8.790|-10.397|0.8685
74025179|NCT01212445|147603230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.311||||0.1865|TWO_SIDED|95.0|-0.774|0.152|||ANCOVA|||||0.152|-0.774|0.1865
74025180|NCT01212445|147603230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.139||||0.553|TWO_SIDED|95.0|-0.602|0.323|||ANCOVA|||||0.323|-0.602|0.5530
73904751|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.2|<|0.001|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Diarrhoea||||< 0.001
73962664|NCT02918071|147461071|OTHER||Percentage|3.0|||||TWO_SIDED|95.0|1.21|6.07|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 to 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12 to 16)|||6.07|1.21|
73962665|NCT02918071|147461071|OTHER||Percentage|1.5|||||TWO_SIDED|95.0|0.69|2.85|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 16)|||2.85|0.69|
73904752|NCT02675231|147339956|SUPERIORITY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|3.0||0.18|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Financial difficulties||||0.180
73904753|NCT02675231|147339957|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.033|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.033
73904754|NCT02675231|147339957|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.275|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.275
73904755|NCT02675231|147339958|SUPERIORITY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|2.02||0.546|TWO_SIDED||||||MMRM Model|||||||0.546
73904756|NCT02675231|147339958|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|2.1||0.62|TWO_SIDED||||||MMRM Model|||||||0.620
73904757|NCT05014490|147339960|EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. The level of significance was set to the standard value of 5% (0.05) for all statistical tests.|Ratio of the T/R geometric mean x 100|102.15|||||TWO_SIDED|90.0|94.54|110.37|||||The ratio of geometric LSmeans with corresponding 90% CI calculated from the exponential of the difference between the test and reference products for the ln-transformed parameters should be within the acceptance interval of 80.00 - 125.00%.|||110.37|94.54|
73904758|NCT05014490|147339961|EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. The level of significance was set to the standard value of 5% (0.05) for all statistical tests.|Ratio of the T/R geometric mean x 100|99.23|||||TWO_SIDED|90.0|96.97|101.54|||||The ratio of geometric LSmeans with corresponding 90% CI calculated from the exponential of the difference between the test and reference products for the ln-transformed parameters should be within the acceptance interval of 80.00 - 125.00%.|||101.54|96.97|
73904759|NCT02220998|147339995|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 120 per treatment group provided 90% power to establish non-inferiority in the SVR12 rates between the SOF/VEL group and the SOF+RBV group. It was based on the assumptions that the non-inferiority margin is 10%, both groups have a SVR12 rate of 94%, and the significance level is 0.025 one-sided.|Difference in proportions|5.2|||||TWO_SIDED|95.0|0.2|10.3|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||10.3|0.2|
73904760|NCT02220998|147339995|SUPERIORITY_OR_OTHER|||||||0.018||||||P-value was stratified by cirrhosis status and prior treatment experience.|Cochran-Mantel-Haenszel|||The superiority of SOF/VEL for 12 weeks over SOF+RBV for 12 weeks was to be tested if the efficacy of SOF/VEL for 12 weeks was demonstrated to be statistically noninferior to SOF+RBV for 12 weeks (ie, if the lower bound of the 95% CI for the strata-adjusted difference in the proportions between groups was greater than the prespecified noninferiority margin of -10%).||||0.018
73904761|NCT00873860|147340001|SUPERIORITY_OR_OTHER|||||||0.573||||||Change at Day 92: p-value was based on analysis of variance (ANOVA).|ANOVA|||||||0.573
73904762|NCT00873860|147340001|SUPERIORITY_OR_OTHER|||||||0.64||||||Change at Day 92: p-value was based on ANOVA.|ANOVA|||||||0.640
73904763|NCT00873860|147340001|SUPERIORITY_OR_OTHER|||||||0.224||||||Change at Day 92: p-value was based on ANOVA.|ANOVA|||||||0.224
73962666|NCT01212991|147461087|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.706|||<|0.0001|TWO_SIDED|95.0|0.596|0.837||A 2-stage group sequential method (Lan DeMets OBF) assigned the level of significance for the pre-specified interim overall survival analysis (p\<0.015) based on overall 2-sided type I error rate of 0.049. Final results based upon interim analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \<1 favoring enzalutamide.|||0.837|0.596|<0.0001
73904764|NCT00873860|147340002|SUPERIORITY_OR_OTHER|||||||0.4686||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.4686
73904765|NCT00873860|147340002|SUPERIORITY_OR_OTHER|||||||0.317||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3170
74025181|NCT01212445|147603230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172||||0.467|TWO_SIDED|95.0|-0.293|0.637|||ANCOVA|||||0.637|-0.293|0.4670
74025182|NCT03232073|147603231|SUPERIORITY||Treatment Effect (Rate Ratio)|0.779||||||95.0|0.629|0.965||||||||0.965|0.629|
74025183|NCT00914628|147603320|SUPERIORITY|||||||0.8974|||||||Log Rank|||||||0.8974
74025184|NCT00914628|147603320|SUPERIORITY|||||||0.7612|||||||Wilcoxon (Mann-Whitney)|||DFS- Intention-To-Treat population- from baseline to day 21||||0.7612
73904766|NCT00873860|147340002|SUPERIORITY_OR_OTHER|||||||0.1664||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.1664
73904767|NCT00873860|147340002|SUPERIORITY_OR_OTHER|||||||0.3234||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3234
73904768|NCT00873860|147340002|SUPERIORITY_OR_OTHER|||||||0.3133||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3133
74084978|NCT01435824|147723606|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.2|||||TWO_SIDED|90.0|97.5|115.7||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||115.7|97.5|
73854912|NCT00473668|147256693|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\<) 10%.|Difference in anti-PRP SPR rate|-1.18|||||TWO_SIDED|95.0|-6.39|2.84||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.||2.84|-6.39|
73854913|NCT00473668|147256693|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\<) 10%.|Difference in anti-PRP SPR rate|0.0|||||TWO_SIDED|95.0|-4.16|3.99||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.||3.99|-4.16|
73854914|NCT02226562|147256708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.0001|TWO_SIDED|95.0|-1.28|-0.92||The P-value was less than 0.0001|ANCOVA|ANCOVA with a factor for treatment and baseline as covariate||||-0.92|-1.28|0.0001
73854915|NCT01474772|147256715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.0659|TWO_SIDED|95.0|-0.46|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints had p-values that were less than 0.05, hence there was no need for multiplicity adjustment.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. Last observation carried forward (LOCF) approach was applied.||0.01|-0.46|0.0659
74025185|NCT00914628|147603320|SUPERIORITY|||||||0.5995|||||||Log Rank|||||||0.5995
74025186|NCT00914628|147603320|SUPERIORITY|||||||0.4078|||||||Wilcoxon (Mann-Whitney)|||DFS- Intention-To-Treat population - day 21 after transplant||||0.4078
74025187|NCT00914628|147603320|SUPERIORITY|||||||0.3351|||||||Log Rank|||DFS- Per-Protocol Set||||0.3351
74025188|NCT00914628|147603320|SUPERIORITY|||||||0.1233|||||||Wilcoxon (Mann-Whitney)|||DFS- Per-Protocol Set||||0.1233
74025189|NCT00914628|147603320|EQUIVALENCE|||||||0.5995|||||||Log Rank|||DFS- Per-Protocol Set DFS-day 21 after transplant||||0.5995
74025190|NCT00914628|147603320|SUPERIORITY|||||||0.4078|||||||Wilcoxon (Mann-Whitney)|||DFS- Per-Protocol Set DFS-day 21 after transplant||||0.4078
74025191|NCT00914628|147603321|SUPERIORITY|||||||0.766|||||||Log Rank|Statistical analysis was performed on Intention-To-Treat population.||||||0.7660
74025192|NCT00914628|147603321|SUPERIORITY|||||||0.6706|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis has been performed for Intention-To-Treat population.||||0.6706
74025193|NCT00914628|147603321|SUPERIORITY|||||||0.7332|||||||Log Rank|||Statistical analysis has been performed for Per-Protocol Set)||||0.7332
74025194|NCT00914628|147603321|SUPERIORITY|||||||0.6439|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis has been performed for Per-Protocol Set)||||0.6439
74025195|NCT00914628|147603322|SUPERIORITY|||||||0.1735|||||||Chi-squared|||This Statistical analysis refers to Immune reconstitution and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.1735
74025196|NCT00914628|147603322|SUPERIORITY|||||||0.5958|||||||Chi-squared|||This Statistical analysis refers to deaths without previous immune reconstitution, relapse or progression and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.5958
74025197|NCT00914628|147603322|SUPERIORITY|||||||0.2889|||||||Chi-squared|||This Statistical Analysis refers to patients with relapse or progression without previous immune reconstitution and was performed Gray's Test for Equality of Cumulative Incidence Functions||||0.2889
73904769|NCT00873860|147340002|SUPERIORITY_OR_OTHER|||||||0.2108||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.2108
74025198|NCT00914628|147603322|SUPERIORITY|||||||0.1642|||||||Chi-squared|||This Statistical analysis refers to Immune reconstitution and was performed by Gray's Test for Equality of Cumulative Incidence Functions for Per-Protocol Set.||||0.1642
74025199|NCT00914628|147603322|SUPERIORITY|||||||0.8739|||||||Log Rank|||This Statistical analysis refers to deaths without previous immune reconstitution, relapse or progression and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.8739
74025200|NCT00914628|147603322|SUPERIORITY|||||||0.2304|||||||Chi-squared|||This Statistical Analysis refers to patients with relapse or progression without previous immune reconstitution and was performed Gray's Test for Equality of Cumulative Incidence Functions||||0.2304
74025201|NCT00914628|147603327|SUPERIORITY|||||||0.3526|||||||Chi-squared|||This Statistical Analysis refers to ITT Patients with relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.3526
74025202|NCT00914628|147603327|SUPERIORITY|||||||0.4035|||||||Chi-squared|||this Gray's Statistical Analysis refers to ITT Deaths patients without previous relapse or progression and was performed with Test for Equality of Cumulative Incidence Functions||||0.4035
74025203|NCT00914628|147603327|SUPERIORITY|||||||0.2607|||||||Chi-squared|||this Gray's Statistical Analysis refers to PPS patients with relapse or progression and was performed with Test for Equality of Cumulative Incidence Functions||||0.2607
73854916|NCT01474772|147256716|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.128||0.0242|TWO_SIDED|95.0|-0.543|-0.038||Primary analysis was two-sided and performed at the 0.05 significance level. Unstructured covariance structure was used to estimate the within-participant errors.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||This longitudinal analysis was a sensitivity analysis of the primary endpoint. P-value was based on a repeated measure mixed effects model including pooled center, time point, treatment, an indicator variable for Week 6 as well as interaction terms as fixed effect factors. For analysis purpose, it is assumed that participants were on placebo at Baseline, took the same treatment as in Period 1 during Week 1 of washout, and were on placebo in Week 2 of washout.||-0.038|-0.543|0.0242
73904770|NCT00873860|147340009|SUPERIORITY_OR_OTHER|||||||0.934||||||ACQ score \<=0.75, Day 92: Fisher exact test was used to compare all arms.|Fisher Exact|||||||0.934
73904771|NCT00873860|147340009|SUPERIORITY_OR_OTHER|||||||0.592||||||ACQ score \<=0.75, Day 169: Fisher exact test was used to compare all arms.|Fisher Exact|||||||0.592
73904772|NCT00873860|147340014|SUPERIORITY_OR_OTHER|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
74025204|NCT00914628|147603327|SUPERIORITY|||||||0.5929|||||||Chi-squared|||this Gray's Statistical Analysis refers to PPS Deaths patients without previous relapse or progression and was performed with Test for Equality of Cumulative Incidence Function||||0.5929
73904773|NCT00873860|147340014|SUPERIORITY_OR_OTHER|||||||0.6022||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||0.6022
73904774|NCT00873860|147340014|SUPERIORITY_OR_OTHER|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
73904775|NCT00873860|147340014|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
74025205|NCT00914628|147603331|SUPERIORITY|||||||0.4035|||||||Chi-squared|||This Statistical Analysis refers to ITT Deaths without previous relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.4035
74025206|NCT00914628|147603331|SUPERIORITY|||||||0.3526|||||||Chi-squared|||This statistical test refers to Patients with relapse or progression and was performed to Gray's Test for Equality of Cumulative Incidence Functions.||||0.3526
73904776|NCT00873860|147340014|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
73904777|NCT00873860|147340014|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
73904778|NCT00873860|147340015|SUPERIORITY_OR_OTHER|||||||0.551||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.551
73904779|NCT00873860|147340015|SUPERIORITY_OR_OTHER|||||||0.492||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.492
73904780|NCT00873860|147340015|SUPERIORITY_OR_OTHER|||||||0.983||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.983
73904781|NCT00873860|147340015|SUPERIORITY_OR_OTHER|||||||0.991||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.991
74025207|NCT00914628|147603331|SUPERIORITY|||||||0.5929|||||||Chi-squared|||This Statistical Analysis refers to PPS Deaths without previous relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.5929
74025208|NCT00914628|147603331|SUPERIORITY|||||||0.2607|||||||Chi-squared|||This statistical test refers to Patients with relapse or progression and was performed to Gray's Test for Equality of Cumulative Incidence Functions.||||0.2607
74025209|NCT00469079|147603342|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.002
73904782|NCT00873860|147340015|SUPERIORITY_OR_OTHER|||||||0.9||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.900
73904783|NCT00873860|147340015|SUPERIORITY_OR_OTHER|||||||0.673||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.673
73904784|NCT00873860|147340016|SUPERIORITY_OR_OTHER|||||||0.546||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.546
73904785|NCT00873860|147340016|SUPERIORITY_OR_OTHER|||||||0.534||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.534
73904786|NCT00873860|147340016|SUPERIORITY_OR_OTHER|||||||0.847||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.847
73904787|NCT00873860|147340016|SUPERIORITY_OR_OTHER|||||||0.987||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.987
73904788|NCT00873860|147340016|SUPERIORITY_OR_OTHER|||||||0.992||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.992
73904789|NCT00873860|147340016|SUPERIORITY_OR_OTHER|||||||0.688||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.688
73904790|NCT00945854|147340018|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
73904791|NCT01610271|147340024|SUPERIORITY|ABS was expected to be superior to Control.|Odds Ratio (OR)|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.067|TWO_SIDED|95.0|0.01|2.05||a priori threshold was 0.05|Regression, Logistic|penalized maximum likelihood (Firth) logistic regression, because infection rate was very low (\<3%), as expected|The dispersion is the SE of the OR. ABS was the numerator group, Control was the denominator.|A sample size of 150 per group provided a power of 80% to detect a statistically significant (α≤0.05) 3% difference in SSI rate based on a historical infection rate of 6% in the facility where operations were performed.||2.05|0.01|0.067
73904792|NCT00364130|147340028|SUPERIORITY_OR_OTHER|||||||0.38||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.38
73904793|NCT00364130|147340029|SUPERIORITY_OR_OTHER|||||||0.8||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.80
73904794|NCT00364130|147340030|SUPERIORITY_OR_OTHER|||||||0.02||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.02
73904795|NCT00364130|147340031|SUPERIORITY_OR_OTHER|||||||0.27||||||The outcome was not adjusted for multiple comparisons|Regression, Linear|||||||0.27
73962667|NCT01212991|147461088|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.186|||<|0.0001|TWO_SIDED|95.0|0.149|0.231||The assigned 2-sided type I error rate was 0.001 for the analysis of radiographic progression-free survival.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.231|0.149|<0.0001
73904796|NCT00364130|147340032|SUPERIORITY_OR_OTHER|||||||0.84||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.84
73904797|NCT00364130|147340033|SUPERIORITY_OR_OTHER|||||||0.66||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.66
73904798|NCT00364130|147340034|SUPERIORITY_OR_OTHER|||||||0.7||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.70
73904799|NCT00364130|147340035|SUPERIORITY_OR_OTHER|||||||0.98||||||Outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.98
73904800|NCT00144027|147340066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.57||||0.03|TWO_SIDED|95.0|1.21|47.53|||Regression, Logistic|logistic regression predicting 6-month adherence, controling for baseline depression, extrapyramidal side effects, and baseline adherence.||||47.53|1.21|0.03
73904801|NCT00395538|147340073|OTHER|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the year 1 biopsy.||||||0.015||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, 2 \& 4 combined as the dependent variable; biopsy year as the independent variable, covariate for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate was included because it would over-parameterize the model.||||0.015
73904802|NCT00395538|147340073|OTHER|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate included because it would over-parameterize the model.||||0.002
73904803|NCT00395538|147340073|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.649||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Cn.BV/TV change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Cn.BV/TV, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.649
74025210|NCT00469079|147603343|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Mixed Models Analysis|||Product use is by self-report and daily diaries.||||0.05
73904804|NCT00395538|147340074|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.N values for both their baseline and year 1 biopsies.||||||0.371||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.371
73904805|NCT00395538|147340074|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.129||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Po.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Po.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.129
73904806|NCT00395538|147340074|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.538||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.538
73904807|NCT00395538|147340075|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the year 1 biopsy.||||||0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|A baseline covariate not added to model since it would over-parameterize the model.||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.009
73904808|NCT00395538|147340075|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
73904809|NCT00395538|147340075|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.374||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.374
73904810|NCT00395538|147340076|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
73930798|NCT01532687|147391473|SUPERIORITY|Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups||||||0.5||||||Yate's continuity correction was applied because of the number of subjects and successes (n = 4)|One-sided Proportions Test|||Statistical results are for the full randomized population (n = 54). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction)||||0.5
74088326|NCT02377921|147730034|SUPERIORITY||LS Mean Difference|-0.4||||0.6938|TWO_SIDED|95.0|-2.38|1.58||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||1.58|-2.38|0.6938
73904811|NCT00395538|147340076|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
73904812|NCT00395538|147340076|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.168||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.168
73904813|NCT00395538|147340077|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.BFR/BS values for both their baseline and year 1 biopsies.||||||0.083||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.083
73904814|NCT00395538|147340077|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
73904815|NCT00395538|147340077|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.164||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.164
73904816|NCT00395538|147340078|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MS/BS values for both their baseline and year 1 biopsies.||||||0.031||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.031
73904817|NCT00395538|147340078|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
73930799|NCT01532687|147391473|SUPERIORITY|||||||0.3||||||Yate's continuity correction was applied because of small number of participants (n = 16) and successes (n = 2).|One-sided Proportion Test|||Statistical results are for the Liposarcoma group (n = 16). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for the secondary endpoints. Given the study closed early due to slow enrollment we do not anticipate detecting a statistical difference between the groups.||||0.3
74088327|NCT02377921|147730035|SUPERIORITY||LS Mean Difference|-1.49||||0.5023|TWO_SIDED|95.0|-5.83|2.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||2.86|-5.83|0.5023
73904818|NCT00395538|147340078|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.178||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.178
73904819|NCT00395538|147340079|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.BFR/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
73904820|NCT00395538|147340079|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.022
73904821|NCT00395538|147340079|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.172||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.172
73904822|NCT00395538|147340080|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
73904823|NCT00395538|147340080|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.018||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.018
73904824|NCT00395538|147340080|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.155||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.155
73930800|NCT01532687|147391473|SUPERIORITY|||||||0.8||||||Yate's continuity correction was applied because of the small number of participants and successes (n = 2).|One-sided Proportion Test|||Statistical results are for the Other Sarcoma group (n = 38). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups.||||0.8
73930801|NCT01532687|147391474|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.481|||||||Gehan-Wilcoxon|||Overall survival estimated among all randomized participants (n = 54)||||0.481
74084979|NCT01435824|147723607|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|101.3|||||TWO_SIDED|90.0|89.4|114.9||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||114.9|89.4|
74088328|NCT02377921|147730036|SUPERIORITY||LS Mean Difference|-0.72||||0.2739|TWO_SIDED|95.0|-2.01|0.57||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||0.57|-2.01|0.2739
73904825|NCT00395538|147340081|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the year 1 biopsy.||||||0.72||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.720
73904826|NCT00395538|147340081|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.944||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.944
73904827|NCT00395538|147340081|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.73||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.730
73904828|NCT00395538|147340082|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the year 1 biopsy.||||||0.019||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.019
73904829|NCT00395538|147340082|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.017||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.017
73962668|NCT01212991|147461089|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.718|||<|0.0001||95.0|0.61|0.844||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.01 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.844|0.610|<0.0001
73962669|NCT01212991|147461090|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.349|||<|0.0001||95.0|0.303|0.403||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0125 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.403|0.303|<0.0001
73962670|NCT01212991|147461091|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.169|||<|0.0001||95.0|0.147|0.195||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0167 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.195|0.147|<0.0001
73962671|NCT01212991|147461092|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rates|74.51|||<|0.0001||95.0|71.45|77.57||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.025 for this analysis.|Cochran-Mantel-Haenszel|||||77.57|71.45|<0.0001
73904830|NCT00395538|147340082|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.843||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.843
73904831|NCT00395538|147340083|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the year 1 biopsy.||||||0.013||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.013
73904832|NCT00395538|147340083|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the years 2 and 4 (combined) biopsy.||||||0.025||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.025
73904833|NCT00395538|147340083|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.608||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.608
73962672|NCT01212991|147461093|SUPERIORITY_OR_OTHER_LEGACY||Difference in objective response rate|53.85|||<|0.0001||95.0|48.53|59.17||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.05 for this analysis.|Cochran-Mantel-Haenszel|||||59.17|48.53|<0.0001
73962673|NCT03546608|147461097|OTHER||Ratio of Geometric Least Square Mean (%)|94.99|||||TWO_SIDED|90.0|64.75|139.35||||||||139.35|64.75|
73962674|NCT03546608|147461097|OTHER||Ratio of Geometric Least Square Mean (%)|87.92|||||TWO_SIDED|90.0|59.93|128.98||||||||128.98|59.93|
73962675|NCT03546608|147461098|OTHER||Ratio of Geometric Least Square Mean (%)|94.81|||||TWO_SIDED|90.0|64.09|140.26||||||||140.26|64.09|
73962676|NCT03546608|147461098|OTHER||Ratio of Geometric Least Square Mean (%)|87.2|||||TWO_SIDED|90.0|58.94|129.0||||||||129.00|58.94|
73962677|NCT03546608|147461099|OTHER||Ratio of Geometric Least Square Mean (%)|102.45|||||TWO_SIDED|90.0|80.9|129.73||||||||129.73|80.90|
73962678|NCT03546608|147461099|OTHER||Ratio of Geometric Least Square Mean (%)|71.02|||||TWO_SIDED|90.0|56.08|89.93||||||||89.93|56.08|
73962679|NCT03546608|147461110|OTHER||Ratio of Geometric Least Square Mean (%)|82.62|||||TWO_SIDED|90.0|45.67|149.47|||||For MSC2571109|||149.47|45.67|
73962680|NCT03546608|147461110|OTHER||Ratio of Geometric Least Square Mean (%)|136.59|||||TWO_SIDED|90.0|75.5|247.12|||||For MSC2571109|||247.12|75.50|
73962681|NCT03546608|147461110|OTHER||Ratio of Geometric Least Square Mean (%)|100.47|||||TWO_SIDED|90.0|54.53|185.1|||||For MSC2571107|||185.10|54.53|
73962682|NCT03546608|147461110|OTHER||Ratio of Geometric Least Square Mean (%)|94.48|||||TWO_SIDED|90.0|51.28|174.07|||||For MSC2571107|||174.07|51.28|
73962683|NCT03546608|147461111|OTHER||Ratio of Geometric Least Square Mean (%)|82.35|||||TWO_SIDED|90.0|45.56|148.84|||||For MSC2571109|||148.84|45.56|
73962684|NCT03546608|147461111|OTHER||Ratio of Geometric Least Square Mean (%)|137.51|||||TWO_SIDED|90.0|76.08|248.54|||||For MSC2571109|||248.54|76.08|
73962685|NCT03546608|147461111|OTHER||Ratio of Geometric Least Square Mean (%)|100.81|||||TWO_SIDED|90.0|55.16|184.23|||||For MSC2571107|||184.23|55.16|
73962686|NCT03546608|147461111|OTHER||Ratio of Geometric Least Square Mean (%)|96.18|||||TWO_SIDED|90.0|52.63|175.78|||||For MSC2571107|||175.78|52.63|
73962687|NCT03546608|147461112|OTHER||Ratio of Geometric Least Square Mean (%)|92.3|||||TWO_SIDED|90.0|62.52|136.26|||||For MSC2571109|||136.26|62.52|
73962688|NCT03546608|147461112|OTHER||Ratio of Geometric Least Square Mean (%)|114.8|||||TWO_SIDED|90.0|77.76|169.48|||||For MSC2571109|||169.48|77.76|
73962689|NCT03546608|147461112|OTHER||Ratio of Geometric Least Square Mean (%)|106.51|||||TWO_SIDED|90.0|70.25|161.49|||||For MSC2571107|||161.49|70.25|
73962690|NCT03546608|147461112|OTHER||Ratio of Geometric Least Square Mean (%)|72.58|||||TWO_SIDED|90.0|47.87|110.04|||||For MSC2571107|||110.04|47.87|
73962691|NCT01622868|147461124|SUPERIORITY|||||||0.97||||||One-sided significance level = 0.10|Z-test|||The study was designed to see if there is a signal in the 12-week CR rate with the addition of lapatinib to warrant a future phase III trial. Null hypothesis: the 12-week post-WBRT/SRS CR rate is ≤ 5%; alternative hypothesis: the addition of lapatinib will increase that CR rate to at least 20%. 114 eligible participants provide 86% power to detect a 15% absolute increase in CR rate at a significance level of 0.10, using a 1-sided Z-test for the difference of 2 proportions.||||0.97
73962692|NCT01622868|147461125|SUPERIORITY|||||||0.78||||||One-sided significance level = 0.10|Z-test|||||||0.78
73962693|NCT01622868|147461126|SUPERIORITY|||||||0.78||||||One-sided significance level = 0.10|Z-test|||4 weeks post-RT||||0.78
74025211|NCT00469079|147603344|SUPERIORITY_OR_OTHER_LEGACY||Other|0.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period.||This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the week-4 visit and at each of the 2 follow-up visits. Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report and confirmed by CO.||||<0.05
74025212|NCT00469079|147603345|SUPERIORITY_OR_OTHER_LEGACY||Mean difference between 3 groups|0.0|||>|0.1|TWO_SIDED|95.0|||||Mixed Models Analysis|||A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period. Each repeated-measures model included the treatment effect, a visit effect, the interaction between treatment and visit, the interaction between subject error and within-subject error terms.||||> 0.10
74088329|NCT02377921|147730037|SUPERIORITY||LS Mean Difference|-2.76||||0.1235|TWO_SIDED|95.0|-6.27|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.75|-6.27|0.1235
73904834|NCT00395538|147340084|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Th values for both their baseline and year 1 biopsies.||||||0.043||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.043
73904835|NCT00395538|147340084|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.334||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.334
73904836|NCT00395538|147340084|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.269||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Th change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Th, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.269
73904837|NCT00395538|147340085|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Ar values for both their baseline and year 1 biopsies.||||||0.358||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.358
73904838|NCT00395538|147340085|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.76||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.760
73930802|NCT01532687|147391474|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.353|||||||Gehan-Wilcoxon|||Overall survival compared between the two arms for the liposarcoma subgroup (n = 16)||||0.353
73962694|NCT01622868|147461126|SUPERIORITY|||||||0.97||||||One-sided significance level = 0.10|Z-test|||12 weeks post-RT||||0.97
73962695|NCT01622868|147461132|SUPERIORITY|||||||1||||||One-sided significance level = 0.10|z-test|||||||1.00
73962696|NCT01622868|147461134|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.67|TWO_SIDED|95.0|0.62|1.36||Two-sided significance level = 0.05|Log Rank|||||1.36|0.62|0.67
74088330|NCT02377921|147730038|SUPERIORITY||LS Mean Difference|-0.43||||0.3907|TWO_SIDED|95.0|-1.4|0.55||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.55|-1.40|0.3907
74088331|NCT02377921|147730039|OTHER||LS Mean Difference|-10.98||||0.1964|TWO_SIDED|95.0|-27.64|5.68||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||5.68|-27.64|0.1964
73904839|NCT00395538|147340085|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.57||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.570
73904840|NCT00395538|147340086|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.Ar values for both their baseline and year 1 biopsies.||||||0.166||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.166
73904841|NCT00395538|147340086|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.895||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.895
73904842|NCT00395538|147340086|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.282||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.282
73904843|NCT00395538|147340087|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the year 1 biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
73904844|NCT00395538|147340087|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
73904845|NCT00395538|147340087|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.68||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.680
73904846|NCT00395538|147340088|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the year 1 biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.006
73904847|NCT00395538|147340088|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
73962697|NCT01164098|147461135|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|Using Natural Log Transformed Data||T-test of the natural logarithmic transformed data||||0.18
73962698|NCT01164098|147461136|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||T-test of Natural Log Transformed Data.||||0.49
73962699|NCT01164098|147461137|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||T-test||||0.37
73962700|NCT01951170|147461144|SUPERIORITY_OR_OTHER|||||||0.83||||||Change in mTSS scores from baseline to Week 24.|Wilcoxon signed rank test|||||||0.83
73962701|NCT01305252|147461166|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
73962702|NCT01305252|147461166|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
73962703|NCT01305252|147461169|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
73962704|NCT01305252|147461169|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
73962705|NCT00077675|147461182|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 91% power to test telavancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 20%||||||0.5318|||||||2-sided 95% confidence interval calculat|||95% Confidence Interval: -0.0527 to 0.1102 No estimated value Parameter that was estimated: Risk Difference||||0.5318
73962706|NCT02706717|147461185|SUPERIORITY||Mean Difference (Net)|-51.3||||0.6|TWO_SIDED|95.0|-246.0|143.9|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||143.9|-246|0.60
73962707|NCT02706717|147461191|SUPERIORITY||Mean Difference (Net)|0.042||||0.51|TWO_SIDED|95.0|-0.09|0.17|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||0.17|-0.09|0.51
73962708|NCT02706717|147461192|SUPERIORITY||Mean Difference (Net)|28.4||||0.09|TWO_SIDED|95.0|-3.6|71.0|||t-test, 2 sided|2-sample t-test with equal variance|"The estimation parameter is the percent difference between the geometric mean fold changes.~With d-dimer data log10 transformed, this is (exp(Visbiome ES mean minus placebo mean) - 1)\*100."|||71.0|-3.6|0.09
73962709|NCT02706717|147461195|SUPERIORITY||Mean Difference (Net)|-32.7||||0.29|TWO_SIDED|95.0|-93.5|28.2|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||28.2|-93.5|0.29
73962710|NCT02706717|147461196|SUPERIORITY||Mean Difference (Net)|-0.02||||0.41|TWO_SIDED|95.0|-0.08|0.04|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||0.04|-0.08|0.41
73962711|NCT02706717|147461213|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
73962712|NCT01911169|147461215|OTHER||Cohen's d|0.68|||||TWO_SIDED|||||||||Effect size of primary outcome was calculated||||
73962713|NCT01911169|147461215|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||This study was conducted to determine the effect size for in change in FMD at 16 weeks with 25(OH) therapy. For change in FMD at 16 weeks with 25(OH)D repletion, based on this effect size, to detect significant differences between 2 groups, assuming 1) normally distributed data, 2) the same effect size, 3) alpha= 0.05, and 4) a power of 0.8, 35 patients in each group would be required. Therefore, this was designed as a pilot to determine effect size.||||> 0.05
73962714|NCT03873337|147461244|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 25||One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at one-month post target quit date (2-months after baseline assessment.||||<0.001
73962715|NCT03873337|147461244|SUPERIORITY|||||||0.002||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at 3-months post target quit date (4 months after baseline assessment.||||0.002
73962716|NCT03873337|147461245|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at one-month post target quit date (2-months after baseline assessment.||||<0.001
73962717|NCT03873337|147461245|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at 3-months post target quit date (4-months after baseline assessment.||||<0.001
73962718|NCT02512965|147461246|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0002|TWO_SIDED|95.0|1.79|6.69||2-sided, adjusted for stratification factors at randomization.|Cochran-Mantel-Haenszel||Mantel-Haenszel estimate stratified by stratification factor at randomization.|||6.69|1.79|0.0002
73962719|NCT02512965|147461247|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0036|TWO_SIDED|95.0|1.35|4.85|||Cochran-Mantel-Haenszel||Mantel-Haenszel estimate stratified by stratification factors at randomization.|||4.85|1.35|0.0036
73962720|NCT02512965|147461248|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.26|TWO_SIDED|95.0|0.46|1.24|||Log Rank|2-sided p-value adjusted for stratification factors at randomization.|Estimate adjusted for stratification factors at randopmization.|||1.24|0.46|0.26
73962721|NCT02512965|147461249|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.47|TWO_SIDED|95.0|0.48|1.4||2-sided p-value adjusted for stratification factors at randomization.|Log Rank|||||1.40|0.48|0.47
73962722|NCT01185782|147461266|NON_INFERIORITY_OR_EQUIVALENCE|"The primary endpoint was to determine whether or not SJ-0021 is inferior to u-hFSH in inducing ovulation. The criterion for non-inferiority was that the lower limit of the two-sided 95% CI (= one-sided 97.5% CI) had to be greater than -15% for SJ-0021 to be considered not inferior to u-hFSH.)"|Delta|-3.51|||||TWO_SIDED|95.0|-13.05|6.04|||Chi-squared|||||6.04|-13.05|
73962723|NCT01185782|147461267|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||Chi-squared|||||||0.214
73962724|NCT01185782|147461268|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||t-test, 2 sided|||||||0.087
73962725|NCT01185782|147461269|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||t-test, 2 sided|||||||0.069
74088332|NCT02377921|147730040|SUPERIORITY||LS Mean Difference|-1.4||||0.2241|TWO_SIDED|95.0|-3.66|0.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER - placebo|||0.86|-3.66|0.2241
73904848|NCT00395538|147340088|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.904||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.904
73904849|NCT00395538|147340089|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
73904850|NCT00395538|147340089|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
73904851|NCT00395538|147340089|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.01||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.010
73904852|NCT00395538|147340090|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the year 1 biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
73904853|NCT00395538|147340090|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
73904854|NCT00395538|147340090|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.020
73930803|NCT01532687|147391474|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.408|||||||Gehan-Wilcoxon|||Overall survival comparison between the two treatment arms for the other sarcoma group (n = 38)||||0.408
73962726|NCT01185782|147461270|SUPERIORITY_OR_OTHER|||||||0.852||95.0|||||Chi-squared|||||||0.852
73962727|NCT01185782|147461271|SUPERIORITY_OR_OTHER|||||||0.102||95.0|||||Chi-squared|||||||0.102
74025213|NCT02698410|147603346|OTHER|||||||0.2968||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Comparison of DCR to 30% clinically relevant threshold.||||0.2968
74025214|NCT02698410|147603346|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
74025215|NCT02698410|147603346|OTHER|||||||0.0534||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Sensitivity Analyisis-1: Comparison of DCR to 30% clinically relevant threshold.||||0.0534
73854917|NCT01474772|147256717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.412|TWO_SIDED|95.0|-0.44|0.18||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints have p-values that are less than 0.05, hence there was no need for multiplicity adjustment.|Mixed-Effect Model Repeated Measures|Satterthwaite's approximation was used to estimate denominator degrees of freedom.||Analysis was done using a repeated measure linear mixed effects model including baseline pain, sequence, period, center, time, treatment, and treatment by time interaction as fixed effect factors and participant within sequence and within-participant error as random factors. The model term 'time' may take 2 values corresponding to Week 3 and Week 6 in each period.||0.18|-0.44|0.4120
73854918|NCT01474772|147256718|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0847|TWO_SIDED|95.0|0.94|2.55||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.||2.55|0.94|0.0847
73854919|NCT01474772|147256719|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.2459|TWO_SIDED|95.0|0.8|2.39||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.||2.39|0.80|0.2459
73854920|NCT01474772|147256720|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.46||0.0889|TWO_SIDED|95.0|-1.71|0.12||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.12|-1.71|0.0889
73854921|NCT01474772|147256721|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.86||0.1781|TWO_SIDED|95.0|-2.86|0.53||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.53|-2.86|0.1781
73854922|NCT01474772|147256722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.2719|TWO_SIDED|95.0|-0.53|0.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.15|-0.53|0.2719
73854923|NCT01474772|147256723|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|563.39|STANDARD_ERROR_OF_MEAN|4098.74||0.8909|TWO_SIDED|95.0|-7549.82|8676.6||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||8676.60|-7549.82|0.8909
73904855|NCT00395538|147340091|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
73962728|NCT01185782|147461272|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Chi-squared|||||||0.560
74025216|NCT02698410|147603346|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Sensitivity Analyisis-1: Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
74025217|NCT02698410|147603346|OTHER|||||||0.032||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Sensitivity Analyisis-2: Comparison of DCR to 30% clinically relevant threshold.||||0.032
74025218|NCT02698410|147603346|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Sensitivity Analyisis-2: Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
74025219|NCT04331899|147603375|OTHER||Cox Proportional Hazard|0.81||||0.29|TWO_SIDED|95.0|0.56|1.19||Tests were conducted at the 0.05 level of significance.|Regression, Cox||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.19|0.56|0.29
74025220|NCT04331899|147603376|OTHER||Cox Proportional Hazard|-0.06||||0.91|TWO_SIDED|95.0|-1.23|1.11||Tests were conducted at the 0.05 level of significance.|Regression, Linear||Log change at Day 14. Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.11|-1.23|0.91
74025221|NCT04331899|147603377|OTHER||Cox Proportional Hazard|1.01||||0.95|TWO_SIDED|95.0|0.85|1.16||Tests were conducted at the 0.05 level of significance.|Regression, Linear||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.16|0.85|0.95
73854924|NCT01474772|147256724|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|206.37||0.9899|TWO_SIDED|95.0|-411.26|406.01||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||406.01|-411.26|0.9899
73854925|NCT01474772|147256725|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.27||0.2854|TWO_SIDED|95.0|-3.88|1.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||1.15|-3.88|0.2854
73854926|NCT01474772|147256726|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|1.09||0.1805|TWO_SIDED|95.0|-3.6|0.68||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.68|-3.60|0.1805
73854927|NCT01474772|147256727|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.33||0.3028|TWO_SIDED|95.0|-0.99|0.31||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.31|-0.99|0.3028
73854928|NCT01474772|147256728|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.7542|TWO_SIDED|95.0|-0.41|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.30|-0.41|0.7542
73854929|NCT01474772|147256729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.68||0.0634|TWO_SIDED|95.0|-2.62|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.07|-2.62|0.0634
73854930|NCT01474772|147256730|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.19||0.1985|TWO_SIDED|95.0|-0.13|0.62||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.62|-0.13|0.1985
73854931|NCT01474772|147256731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9686|TWO_SIDED|95.0|-0.21|0.2||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.20|-0.21|0.9686
73854932|NCT01474772|147256732|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.54||||0.002|TWO_SIDED|95.0|1.3|4.95|||Cochran-Mantel-Haenszel|||Odds ratio is based on the binary response for any improvement while p-value is from the comparison of the original scale of 7 possible outcomes. P-value was calculated by using Cochran Mantel-Haenszel (CMH) test. PGIC values at the end of Period 1 data was compared between treatment groups.||4.95|1.30|0.0020
73962729|NCT01185782|147461273|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||Chi-squared|||||||0.555
73962730|NCT01185782|147461274|SUPERIORITY_OR_OTHER|||||||0.416||95.0|||||Chi-squared|||||||0.416
74025222|NCT04331899|147603378|OTHER||Cox Proportional Hazard|0.94||||0.76|TWO_SIDED|95.0|0.6|1.41||Tests were conducted at the 0.05 level of significance.|Regression, Cox||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.41|0.60|0.76
74088333|NCT02377921|147730041|OTHER||LS Mean Difference|-0.32||||0.5608|TWO_SIDED|95.0|-1.39|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.75|-1.39|0.5608
73962731|NCT03292913|147461332|SUPERIORITY||Risk Ratio (RR)|1.07||||0.22|TWO_SIDED|95.0|0.96|1.21|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, viral load suppression at baseline, and new to care.||Outcome measure for this analysis is viral load suppression. A priori threshold for statistical significance is p-value less than 0.05.||1.21|0.96|0.220
73962732|NCT03292913|147461333|SUPERIORITY||Risk Ratio (RR)|1.04||||0.481|TWO_SIDED|95.0|0.94|1.15|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, and new to care.||Outcome measure for this analysis is retention in care. A priori threshold for statistical significance is p-value less than 0.05.||1.15|0.94|0.481
73962733|NCT03292913|147461334|SUPERIORITY||Risk Ratio (RR)|0.86||||0.093|TWO_SIDED|95.0|0.72|1.03|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, and new to care.||Outcome measure for this analysis is a 6-month visit gap defined ashaving at least 189 days between two sequentially kept visits, post-randomization. A priori threshold for statistical significance is p-value less than 0.05.||1.03|0.72|0.093
73854933|NCT01474772|147256733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.0105|TWO_SIDED|95.0|-0.68|-0.09||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||-0.09|-0.68|0.0105
74025223|NCT00101361|147603380|NON_INFERIORITY_OR_EQUIVALENCE|the required sample size of 400 participants provided 85% power to detect an increase in healing from 25% in the placebo group to 40% in the oxandrolone group, as assuming a 0.05 (2-sided) type I error, 13% rate of loss to follow up, and a test of proportions by using an arcsine transformation.|Mean Difference (Final Values)|-5.7|||<|0.05|TWO_SIDED|95.0|-17.5|6.8|||Cochran-Mantel-Haenszel|||For spinal cord injury patients with a Stage III or IV pressure ulcer of the pelvic region who receive 24 weeks or less of optimized clinical care (i.e., guideline-driven care with nutritional support) compared with optimized clinical care and an oral anabolic steroid agent (oxandrolone) there will be no difference in the percent of healed pressure ulcers.||6.8|-17.5|<0.05
74025224|NCT00893789|147603388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8336||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.8336
74025225|NCT00893789|147603388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0514||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.0514
73854934|NCT01474772|147256734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1178|TWO_SIDED|95.0|-0.63|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.07|-0.63|0.1178
73854935|NCT01474772|147256735|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.18||0.199|TWO_SIDED|95.0|-0.6|0.13||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.13|-0.60|0.1990
73854936|NCT01474772|147256736|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.02||0.71107|TWO_SIDED|95.0|-0.025|0.037||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 1997. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.037|-0.025|0.71107
73854937|NCT01474772|147256736|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.02||0.53965|TWO_SIDED|95.0|-0.021|0.039||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 2001. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.039|-0.021|0.53965
73962734|NCT03950622|147461335|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-2.4||||0.175|TWO_SIDED|95.0|-5.8|1.1|||Miettinen & Nurminen|||Injection site redness/erythema||1.1|-5.8|0.175
73962735|NCT03950622|147461335|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|11.7|||<|0.001|TWO_SIDED|95.0|6.0|17.2|||Miettinen & Nurminen|||Injection site tenderness/pain||17.2|6.0|<0.001
73962736|NCT03950622|147461335|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.3||||0.488|TWO_SIDED|95.0|-2.4|5.0|||Miettinen & Nurminen|||Injection site swelling||5.0|-2.4|0.488
74088334|NCT00595335|147730088|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||Comparison of the change between the two groups' CAS score at 6 months.||||0.73
74088335|NCT00595335|147730089|SUPERIORITY_OR_OTHER|||||||0.75|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 6 months.||||0.75
74025226|NCT00893789|147603388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.0010
73854938|NCT03458910|147256752|SUPERIORITY|||||||0.782|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.782
73854939|NCT03458910|147256753|SUPERIORITY|||||||0.48|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.480
73854940|NCT03458910|147256754|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.410
73854941|NCT03458910|147256755|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.480
73854942|NCT03458910|147256756|SUPERIORITY|||||||0.17|||||||ANOVA|||time x condition x regulation goal interaction in behavioral emotional intensity rating for younger adults||||0.170
73854943|NCT03458910|147256757|SUPERIORITY|||||||0.478|||||||ANOVA|||time x condition x regulation goal interaction in behavioral emotional intensity rating for older adults||||0.478
73854944|NCT03458910|147256758|SUPERIORITY|||||||0.441|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the left amygdala for younger adults||||0.441
73854945|NCT03458910|147256759|SUPERIORITY|||||||0.621|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the left amygdala for older adults||||0.621
73854946|NCT03458910|147256760|SUPERIORITY|||||||0.19|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the right amygdala activity for younger adults||||0.190
73854947|NCT03458910|147256761|SUPERIORITY|||||||0.864|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the right amygdala activity for older adults||||0.864
73854948|NCT03458910|147256762|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparing acceptance rate of fair offers||||1.000
73930804|NCT03160703|147391475|SUPERIORITY||Mean Difference (Net)|-0.02||||0.2681|TWO_SIDED|95.0|-0.05|0.01||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.01|-0.05|0.2681
74025227|NCT00893789|147603389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7884||95.0|||||Pearson's chi-squared|||||||0.7884
74088336|NCT00595335|147730089|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.||||0.85
74088337|NCT00595335|147730091|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||Comparison of the change between the two groups in proptosis in the right eye at 12 months.||||0.97
73854949|NCT03458910|147256762|SUPERIORITY|||||||0.716|||||||Wilcoxon (Mann-Whitney)|||Comparing acceptance rate of unfair offers||||0.716
73854950|NCT03458910|147256763|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups for dorsal anterior cingulate cortex activation.||||0.014
73854951|NCT03458910|147256763|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups for anterior insula activation.||||0.059
73854952|NCT03458910|147256764|SUPERIORITY|||||||0.144|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||.144
73854953|NCT03458910|147256764|SUPERIORITY|||||||0.653||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|||||||0.653
73854954|NCT03458910|147256765|SUPERIORITY|||||||0.288|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||.288
73854955|NCT03458910|147256765|SUPERIORITY|||||||0.191||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.191
73854956|NCT03458910|147256766|SUPERIORITY|||||||0.894|||||||ANOVA|||||||0.894
73854957|NCT03458910|147256766|SUPERIORITY|||||||0.425||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.425
73854958|NCT03458910|147256767|SUPERIORITY|||||||0.916|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.916
73854959|NCT03458910|147256767|SUPERIORITY|||||||0.235||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.235
73854960|NCT03458910|147256768|SUPERIORITY|||||||0.462|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.462
73854961|NCT03458910|147256768|SUPERIORITY|||||||0.468||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.468
73854962|NCT03458910|147256769|SUPERIORITY|||||||0.481|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.481
73854963|NCT03458910|147256769|SUPERIORITY|||||||0.159||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.159
73854964|NCT03458910|147256770|SUPERIORITY|||||||0.602|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.602
73854965|NCT03458910|147256770|SUPERIORITY|||||||0.562||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.562
74025228|NCT00893789|147603389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2359||95.0|||||Pearson's chi-squared|||||||0.2359
74025229|NCT00893789|147603389|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4401||95.0|||||Pearson's chi-squared|||||||0.4401
74088338|NCT00595335|147730091|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||Comparison of the change between the two groups in change in proptosis in left eye at 12 months.||||0.86
73904856|NCT00395538|147340091|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.022
74025230|NCT03818815|147603415|SUPERIORITY|||||||0.62||||||The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.|Regression, Logistic|||The summary statistics are based on subjects with non-missing data only.||||0.62
74025231|NCT03818815|147603416|SUPERIORITY|||||||0.07||||||The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.|Regression, Logistic|||The summary statistics are based on subjects with non-missing data only.||||0.07
74088339|NCT00595335|147730092|SUPERIORITY_OR_OTHER|||||||0.98|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the right eye between the two groups.||||0.98
73904857|NCT00395538|147340091|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.228||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.228
73904858|NCT00395538|147340092|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
73904859|NCT00395538|147340092|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.006
73904860|NCT00395538|147340092|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.67||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.670
73904861|NCT00395538|147340093|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MAR values for both their baseline and year 1 biopsies.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
73904862|NCT00395538|147340093|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
74025232|NCT01475955|147603457|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Chi-squared|||Pearson chi-square||||0.0041
74088340|NCT00595335|147730092|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the left eye between the two groups.||||0.49
73904863|NCT00395538|147340093|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.712||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.712
73904864|NCT00395538|147340094|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.OS/BS values for both their baseline and year 1 biopsies.||||||0.029||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.029
73904865|NCT00395538|147340094|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
73904866|NCT00395538|147340094|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.104||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.104
73904867|NCT00395538|147340095|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.ES/BS values for both their baseline and year 1 biopsies.||||||0.088||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.088
73930805|NCT03160703|147391475|SUPERIORITY||Mean Difference (Net)|-0.05||||0.0043|TWO_SIDED|95.0|-0.08|-0.02||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.02|-0.08|0.0043
74025233|NCT02039947|147603619|SUPERIORITY||Response rate|59.0|||<|0.0001|TWO_SIDED|95.0|47.3|70.4|||percent||Percent|||70.4|47.3|<.0001
73930806|NCT03160703|147391475|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.12|-0.05||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.05|-0.12|<.0001
74025234|NCT01772134|147603627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|||<|0.001|TWO_SIDED|95.0|0.107|0.187|||Mixed Models Analysis|||||0.187|0.107|<0.001
74025235|NCT01772134|147603627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138|||<|0.001|TWO_SIDED|95.0|0.097|0.178|||Mixed Models Analysis|||||0.178|0.097|<0.001
74088341|NCT00595335|147730093|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 6 months.||||0.21
73930807|NCT03160703|147391475|SUPERIORITY||Mean Difference (Final Values)|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.08||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.08|-0.15|<.0001
73930808|NCT03160703|147391475|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.0779|TWO_SIDED|95.0|0.0|0.06||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.06|-0.00|0.0779
73930809|NCT03160703|147391475|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.0001|TWO_SIDED|95.0|0.03|0.1||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.10|0.03|0.0001
73962737|NCT03950622|147461336|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.2||||0.888|TWO_SIDED|95.0|-2.8|2.4|||Miettinen & Nurminen|||Joint pain/arthralgia||2.4|-2.8|0.888
73962738|NCT03950622|147461336|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.1||||0.96|TWO_SIDED|95.0|-4.2|4.4|||Miettinen & Nurminen|||Tiredness/fatigue||4.4|-4.2|0.960
73962739|NCT03950622|147461336|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-1.4||||0.469|TWO_SIDED|95.0|-5.1|2.4|||Miettinen & Nurminen|||Headache||2.4|-5.1|0.469
73962740|NCT03950622|147461336|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|3.4||||0.082|TWO_SIDED|95.0|-0.4|7.4|||Miettinen & Nurminen|||Muscle pain/myalgia||7.4|-0.4|0.082
73962741|NCT03950622|147461337|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||Miettinen & Nurminen|||Vaccine-related SAEs||0.6|-0.6|
74025236|NCT01740362|147603631|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|137.26|||||TWO_SIDED|90.0|96.77|194.69||||||1 way Analysis of Variance (ANOVA) on natural log-transformed AUC(0-∞) analyzed using linear model with degrees of renal impairment(creatinine clearance\[CLcr, discrete\]) evaluated using blood samples collected at screening as fixed effect. Statistical Analysis System (SAS) mixed procedure (PROC MIXED) was used. Anti-log of adjusted mean difference (CP-690,550\[mild renal insufficiency\] - CP-690,550\[normal renal function\]), 90% confidence interval (CI) were taken to estimate mean ratio and 90% CI.||194.69|96.77|
74088342|NCT00595335|147730093|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 12 months.||||0.64
74088343|NCT00595335|147730094|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 6 months.||||0.36
74088344|NCT00595335|147730094|SUPERIORITY_OR_OTHER|||||||0.91|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 6 months.||||0.91
73854966|NCT03458910|147256771|SUPERIORITY|||||||0.697|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.697
73854967|NCT03458910|147256771|SUPERIORITY|||||||0.901||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.901
73854968|NCT03458910|147256772|SUPERIORITY|||||||0.516|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.516
73854969|NCT03458910|147256773|SUPERIORITY|||||||0.944|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.944
73854970|NCT03458910|147256774|SUPERIORITY|||||||0.285|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.285
73854971|NCT03458910|147256775|SUPERIORITY|||||||0.807|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.807
73854972|NCT03458910|147256776|SUPERIORITY||||||<|0.001|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||<0.001
73854973|NCT03458910|147256777|SUPERIORITY|||||||0.74|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.740
73854974|NCT03458910|147256778|SUPERIORITY|||||||0.083|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.083
73854975|NCT03458910|147256779|SUPERIORITY|||||||0.176|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.176
73854976|NCT03458910|147256780|SUPERIORITY|||||||0.325|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.325
73854977|NCT03458910|147256781|SUPERIORITY|||||||0.751|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.751
73854978|NCT03458910|147256782|SUPERIORITY|||||||0.011|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.011
73854979|NCT03458910|147256783|SUPERIORITY|||||||0.885|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.885
73854980|NCT03458910|147256784|SUPERIORITY|||||||0.259||||||p-value reflects time x condition interaction|ANOVA|||2 (time) x 2 (condition) ANOVA to test effects of time, condition, and time x condition interaction||||0.259
73854981|NCT03458910|147256785|SUPERIORITY|||||||0.000146||||||p-value reflects time x condition interaction|ANOVA|||2 (time) x 2 (condition) ANOVA to test effects of time, condition, and time x condition interaction||||0.000146
73854982|NCT03458910|147256786|SUPERIORITY|||||||0.463||||||time point x group (2 way) interaction|ANOVA|||||||0.463
73854983|NCT03458910|147256787|SUPERIORITY|||||||0.99||||||time point x group (2 way) interaction|ANOVA|||||||0.990
73854984|NCT03458910|147256788|SUPERIORITY|||||||0.034||||||time point x group (2 way) interaction|ANOVA|||||||0.034
73854985|NCT03458910|147256789|SUPERIORITY|||||||0.398||||||time point x group (2 way) interaction|ANOVA|||||||0.398
73854986|NCT03458910|147256790|SUPERIORITY|||||||0.113||||||time point x group (2 way) interaction|ANOVA|||||||0.113
73854987|NCT03458910|147256791|SUPERIORITY|||||||0.637||||||time point x group (2 way) interaction|ANOVA|||||||0.637
73854988|NCT03458910|147256792|SUPERIORITY|time x condition interaction in CRP for younger adults||||||0.133|||||||ANOVA|||||||0.133
73854989|NCT03458910|147256793|SUPERIORITY|time x condition interaction in CRP for older adults||||||0.402|||||||ANOVA|||||||0.402
73854990|NCT03458910|147256794|SUPERIORITY|time x condition interaction in cytokine IL-1b for younger adults||||||0.236||||||p value for time x condition interaction effect|ANOVA|||||||0.236
73854991|NCT03458910|147256795|SUPERIORITY|time x condition interaction in cytokine IL-1b for older adults||||||0.6||||||p value for time x condition interaction effect|ANOVA|||||||0.600
73854992|NCT03458910|147256796|SUPERIORITY|time x condition interaction in cytokine IL-6 for younger adults||||||0.788||||||p value for time x condition interaction effect|ANOVA|||||||0.788
73854993|NCT03458910|147256797|SUPERIORITY|time x condition interaction in cytokine IL-6 for older adults||||||0.917||||||p value for time x condition interaction effect|ANOVA|||||||0.917
73904868|NCT00395538|147340095|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.009
73904869|NCT00395538|147340095|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.325||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.325
73930810|NCT01513291|147391483|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.33153|TWO_SIDED|95.0|-1.3|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, \>8) as covariates|||0.4|-1.3|0.33153
73962742|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.96|||Constrained longitudinal data analysis|GMT ratio, 95% CI, and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||Serotype 1 (Shared)||0.96|0.66|<0.001
73962743|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.38|1.85|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 3 (Shared)||1.85|1.38|<0.001
73962744|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.57|0.8|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 4 (Shared)||0.80|0.57|<0.001
73962745|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.64|0.98|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 5 (Shared)||0.98|0.64|<0.001
74025237|NCT01740362|147603631|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|142.59|||||TWO_SIDED|90.0|100.53|202.24||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[moderate renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||202.24|100.53|
74025238|NCT01740362|147603631|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|222.71|||||TWO_SIDED|90.0|157.02|315.89||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[severe renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||315.89|157.02|
74084980|NCT01435824|147723608|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|107.9|||||TWO_SIDED|90.0|84.5|137.8||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||137.8|84.5|
73962746|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.84|1.19|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 6A (Shared)||1.19|0.84|<0.001
73930811|NCT01513291|147391484|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.3|||||TWO_SIDED|95.0|-3.4|21.6|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen \& Nurminen method|||21.6|-3.4|
73930812|NCT01513291|147391485|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.3|||||TWO_SIDED|95.0|-4.0|8.9|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen \& Nurminen method|||8.9|-4.0|
73962747|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.23|||<|0.001|TWO_SIDED|95.0|1.02|1.48|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 6B (Shared)||1.48|1.02|<0.001
73962748|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.68|0.9|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 7F (Shared)||0.90|0.68|<0.001
73962749|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.7|0.94|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 9V (Shared)||0.94|0.70|<0.001
73962750|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.64|0.89|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 14 (Shared)||0.89|0.64|<0.001
73962751|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.07|||<|0.001|TWO_SIDED|95.0|0.91|1.26|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 18C (Shared)||1.26|0.91|<0.001
74088345|NCT00595335|147730094|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 12 months.||||0.29
73854994|NCT03458910|147256798|SUPERIORITY|time x condition interaction in cytokine IL-8 for younger adults||||||0.844||||||p value for time x condition interaction effect|ANOVA|||||||0.844
73854995|NCT03458910|147256799|SUPERIORITY|time x condition interaction in cytokine IL-8 for older adults||||||0.75||||||p value for time x condition interaction effect|ANOVA|||||||0.750
73854996|NCT03458910|147256800|SUPERIORITY|time x condition interaction in cytokine TNF-a for younger adults||||||0.074||||||p value for time x condition interaction effect|ANOVA|||||||0.074
73854997|NCT03458910|147256801|SUPERIORITY|time x condition interaction in cytokine TNF-a for older adults||||||0.0505||||||p value for time x condition interaction effect|ANOVA|||||||0.0505
73854998|NCT03458910|147256816|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.022
73854999|NCT03458910|147256817|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.455
73855000|NCT03458910|147256818|SUPERIORITY|||||||0.022|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.022
73855001|NCT03458910|147256819|SUPERIORITY|||||||0.455|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.455
73855002|NCT03458910|147256820|SUPERIORITY|||||||0.462||||||time point x group (2 way) interaction|ANOVA|||||||0.462
73855003|NCT03458910|147256821|SUPERIORITY|||||||0.305||||||time point x group (2 way) interaction|ANOVA|||||||0.305
73855004|NCT03458910|147256822|SUPERIORITY|||||||0.804||||||time point x group (2 way) interaction|ANOVA|||||||0.804
73855005|NCT03458910|147256823|SUPERIORITY|||||||0.141||||||time point x group (2 way) interaction|ANOVA|||||||0.141
73855006|NCT03458910|147256824|SUPERIORITY|||||||0.292||||||time point x group(2 way) interaction|ANOVA|||||||0.292
73855007|NCT03458910|147256825|SUPERIORITY|||||||0.905||||||time point x group (2 way) interaction|ANOVA|||||||0.905
73855008|NCT03458910|147256826|SUPERIORITY|||||||0.641||||||p value for time x condition x error type interaction effect|ANOVA|||time x condition x error type interaction in Sustained Attention to Response Task (SART) for younger adults||||0.641
73855009|NCT03458910|147256827|SUPERIORITY|||||||0.813||||||p value for time x condition x error type interaction effect|ANOVA|||time x condition x error type interaction in Sustained Attention to Response Task (SART) for older adults||||0.813
73855010|NCT03458910|147256828|SUPERIORITY|||||||0.695|||||||ANOVA|||Hits during recognition task for younger adults||||.695
73855011|NCT03458910|147256829|SUPERIORITY|||||||0.27|||||||ANOVA|||Hits during recognition task for older adults||||.270
73855012|NCT03458910|147256830|SUPERIORITY|||||||0.102|||||||ANOVA|||False alarms during recognition task for younger adults||||.102
73855013|NCT03458910|147256831|SUPERIORITY|||||||0.257|||||||ANOVA|||False alarms during recognition task for older adults||||.257
73855014|NCT03458910|147256832|SUPERIORITY|||||||0.067|||||||ANOVA|||Group difference for recall for younger adults||||.067
73855015|NCT03458910|147256833|SUPERIORITY|||||||0.117|||||||ANOVA|||Group difference for recall for older adults||||.117
73855016|NCT03458910|147256834|SUPERIORITY|||||||0.558||||||p value for time x condition interaction effect|ANOVA|||time x condition x collection interaction in cortisol levels for younger adults||||0.558
73855017|NCT02731820|147256862|OTHER|||||||0.172|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.172
73855018|NCT02731820|147256862|OTHER|||||||0.027|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.027
73855019|NCT02731820|147256862|OTHER|||||||0.053|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.053
73855020|NCT02731820|147256862|OTHER|||||||0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.002
73855021|NCT02731820|147256862|OTHER|||||||0.006|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.006
73855022|NCT02731820|147256862|OTHER|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.139
73855023|NCT02731820|147256862|OTHER|||||||0.967|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.967
73855024|NCT02731820|147256862|OTHER|||||||0.446|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.446
73855025|NCT02731820|147256862|OTHER|||||||0.869|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.869
73855026|NCT02731820|147256863|OTHER|||||||0.954|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.954
73855027|NCT02731820|147256863|OTHER|||||||0.798|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.798
73855028|NCT02731820|147256863|OTHER|||||||0.377|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.377
73855029|NCT02731820|147256863|OTHER|||||||0.886|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.886
73962752|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.7|0.93|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 19A (Shared)||0.93|0.70|<0.001
73962753|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.76|1.02|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 19F (Shared)||1.02|0.76|<0.001
74025239|NCT01740362|147603632|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|93.15|||||TWO_SIDED|90.0|67.22|129.06||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[mild renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||129.06|67.22|
73904870|NCT00395538|147340096|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 3 participants with non-missing Ec.AjAR values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
73904871|NCT00395538|147340096|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
73930813|NCT01513291|147391486|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.5||||0.24008|TWO_SIDED|95.0|-1.4|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, \>8) as covariates|||0.4|-1.4|0.24008
73930814|NCT01513291|147391487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.43093|TWO_SIDED|95.0|0.7|2.0|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period 1 (≤8, \>8) as covariates.|||2.0|0.7|0.43093
73962754|NCT03950622|147461338|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.96|1.44|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 23F (Shared)||1.44|0.96|<0.001
74025240|NCT01740362|147603632|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|104.17|||||TWO_SIDED|90.0|75.18|144.34||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[moderate renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||144.34|75.18|
73962755|NCT03950622|147461338|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 2.0.|GMT Ratio|31.83|||<|0.001|TWO_SIDED|95.0|25.35|39.97|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 22F (Unique to V114)||39.97|25.35|<0.001
73962756|NCT03950622|147461338|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 2.0.|GMT Ratio|7.11|||<|0.001|TWO_SIDED|95.0|6.07|8.32|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 33F (Unique to V114)||8.32|6.07|<0.001
73962757|NCT03950622|147461339|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the differences \[V114 - Prevnar 13™\] between the proportions of participants with a ≥4-fold rise from prevaccination \[Day 1\] to 30 days postvaccination \[Day 30\] to be greater than 0.1.|Percentage Point Difference|57.1|||<|0.001|TWO_SIDED|95.0|52.0|61.8|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 22F (Unique to V114)||61.8|52.0|<0.001
73962758|NCT03950622|147461339|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the differences \[V114 - Prevnar 13™\] between the proportions of participants with a ≥4-fold rise from prevaccination \[Day 1\] to 30 days postvaccination \[Day 30\] to be greater than 0.1)|Percentage Point Difference|50.5|||<|0.001|TWO_SIDED|95.0|45.9|54.9|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 33F (Unique to V114)||54.9|45.9|<0.001
74025241|NCT01740362|147603632|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|117.65|||||TWO_SIDED|95.0|84.91|163.02||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[severe renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||163.02|84.91|
73904872|NCT00395538|147340096|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.974||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.974
73962759|NCT03950622|147461340|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 1.2.|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.38|1.85|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 3 (Shared)||1.85|1.38|<0.001
73904873|NCT00395538|147340097|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
73904874|NCT00395538|147340097|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.023||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.023
73904875|NCT00395538|147340097|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.288||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.288
73904876|NCT00395538|147340098|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MAR values for both their baseline and year 1 biopsies.||||||0.202||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.202
73904877|NCT00395538|147340098|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.486||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.486
73962760|NCT03950622|147461341|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the difference(V114 - Prevnar 13™) between the proportions of participants with a ≥4-fold rise from prevaccination (Day 1) to 30 days postvaccination (Day 30) to be greater than 0.|Percentage Point Difference|11.5|||<|0.001|TWO_SIDED|95.0|6.0|16.9|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 3 (Shared) ≥4-Fold Rise in OPA||16.9|6.0|<0.001
73962761|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 1 (Shared)||0.83|0.62|
73962762|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.51|||||TWO_SIDED|95.0|1.33|1.71||||||Serotype 3 (Shared)||1.71|1.33|
73962763|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 4 (Shared)||0.83|0.62|
74025242|NCT01273818|147603696|SUPERIORITY_OR_OTHER||Fscher exact test|||||0.198|TWO_SIDED||||||Fisher Exact||we did not need an estimation parameter such as odds or relative risk because of our experimental design and hypothesis of this study.|"Comparison Group Selection: our primary outcome is infection positive or negativeso, we compared the frequencies of being positive infections for these three groups. Our null hypothesis is  positive infection frequencies are same for three groups. We calculated post-hoc power for this design and found 0.99 for the percentages which shows positive infections respectively for Topical Gentamicin, cefazoline iv and topical gentamicin and iv cefazolin; 2.3%, 3.1% and 0%."||||0.198
74025243|NCT03815175|147603697|NON_INFERIORITY|"H0: Death/(MI\[1m-DAPT\]) - Death/(MI \[XIENCE V USA\]) ≥ δ HA: Death/MI(\[1m-DAPT\]) - Death/(MI \[XIENCE V USA: NCT00676520\]) \< δ~Where δ is the non-inferiority margin. The test will be carried out with a one-sided significance level of 0.025 and a non-inferiority margin (δ) of 2.5%."||||||0.0005|||||||Farrington-Manning method|||||||0.0005
74025244|NCT03815175|147603700|SUPERIORITY|"H0: B (1m-DAPT) - B (XIENCE V USA) ≥ 0 HA: B (1m-DAPT) - B (XIENCE V USA: NCT00676520) \< 0~B 1m-DAPT and B XIENCE V USA are bleeding rates (BARC type 2-5) between 1-month and 6-month follow-up for the pooled 1-month DAPT arm and XIENCE V USA historical control, respectively."||||||0.1888|||||||Farrington and Manning method|||||||0.1888
74084981|NCT03239496|147723612|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 1 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
73855030|NCT02731820|147256863|OTHER|||||||0.04|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.040
73855031|NCT02731820|147256863|OTHER|||||||0.017|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.017
73855032|NCT02731820|147256863|OTHER|||||||0.343|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.343
73855033|NCT02731820|147256863|OTHER|||||||0.859|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.859
73855034|NCT02731820|147256863|OTHER|||||||0.172|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.172
73855035|NCT02731820|147256864|OTHER|||||||0.213|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.213
73855036|NCT02731820|147256864|OTHER|||||||0.191|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.191
73855037|NCT02731820|147256864|OTHER|||||||0.234|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.234
73930815|NCT01513291|147391488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9737|TWO_SIDED|95.0|0.7|1.5|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Treatment Period 1 (≤8, \>8) as covariates.|||1.5|0.7|0.97370
73855038|NCT02731820|147256864|OTHER|||||||0.37|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.370
73855039|NCT02731820|147256864|OTHER|||||||0.176|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.176
73855040|NCT02731820|147256864|OTHER|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.139
73855041|NCT02731820|147256864|OTHER|||||||0.551|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.551
73855042|NCT02731820|147256864|OTHER|||||||0.371|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.371
73855043|NCT02731820|147256864|OTHER|||||||0.466|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.466
73855044|NCT02731820|147256865|OTHER|||||||0.094|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.094
73855045|NCT02731820|147256865|OTHER|||||||0.0004|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.0004
73855046|NCT02731820|147256865|OTHER|||||||0.008|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.008
73855047|NCT02731820|147256865|OTHER|||||||0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.002
73855048|NCT02731820|147256865|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||<0.0001
73855049|NCT02731820|147256865|OTHER|||||||0.0007|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.0007
73930816|NCT03732638|147391489|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0099|TWO_SIDED|95.0|-1.46|-0.2|||Mixed Models Analysis|||||-0.20|-1.46|0.0099
73855050|NCT02731820|147256865|OTHER|||||||0.458|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.458
73855051|NCT02731820|147256865|OTHER|||||||0.434|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.434
73855052|NCT02731820|147256865|OTHER|||||||0.555|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.555
73855053|NCT00152477|147256882|SUPERIORITY||Difference of response rate|6.4|||=|0.384|TWO_SIDED|95.0|-7.7|20.5||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \<5.|Cochran-Mantel-Haenszel|||||20.5|-7.7|=0.384
73855054|NCT00152477|147256882|SUPERIORITY||Difference of response rate|6.4|||=|0.409||95.0|-7.7|20.5||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||20.5|-7.7|=0.409
73962764|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.96||||||Serotype 5 (Shared)||0.96|0.70|
73962765|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.87|1.21||||||Serotype 6A (Shared)||1.21|0.87|
73962766|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.39|||||TWO_SIDED|95.0|1.17|1.64||||||Serotype 6B (Shared)||1.64|1.17|
73962767|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.66|0.89||||||Serotype 7F (Shared)||0.89|0.66|
73962768|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|1.0||||||Serotype 9V (Shared)||1.00|0.75|
73962769|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 14 (Shared)||0.89|0.65|
73962770|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.05||||||Serotype 18C (Shared)||1.05|0.77|
73962771|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.97||||||Serotype 19A (Shared)||0.97|0.73|
73962772|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.05||||||Serotype 19F (Shared)||1.05|0.78|
73962773|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 23F (Shared)||1.28|0.92|
74084982|NCT03239496|147723613|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
73855055|NCT00152477|147256882|SUPERIORITY||Difference of response rate|2.6|||=|0.744|TWO_SIDED|95.0|-13.5|18.8||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \< 5.|Chi-squared|||||18.8|-13.5|=0.744
73962774|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|10.62|||||TWO_SIDED|95.0|9.37|12.03||||||Serotype 22F (Unique to V114)||12.03|9.37|
73962775|NCT03950622|147461342|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.98|||||TWO_SIDED|95.0|8.0|10.07||||||Serotype 33F (Unique to V114)||10.07|8.00|
73962776|NCT01546753|147461348|SUPERIORITY|The change from baseline OFC to week 38 OFC (primary outcome measure) was compared between the two groups using a Mann-Whitney U test.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73962777|NCT01546753|147461349|SUPERIORITY|Differences in dichotomous outcomes for the percentage of participants who reach the 5000 mg cumulative dose to the walnut at the week 38 desensitization OFC was analyzed using Fisher's exact test||||||0.01|||||||Fisher Exact|||||||0.01
73962778|NCT01546753|147461350|SUPERIORITY|Differences in dichotomous outcomes including the percentage of subjects who reach the 2000 mg cumulative dose to the walnut at the week 38 desensitization OFC was analyzed using Fisher's exact test|||||<|0.01|||||||Fisher Exact|||||||<0.01
73962779|NCT01546753|147461351|SUPERIORITY|Differences in dichotomous outcomes such as the percentage of subjects who reach the 2000 mg cumulative dose to the tree nut at the week 38 desensitization OFC was analyzed using Fisher's exact test|||||<|0.01|||||||Fisher Exact|||||||<0.01
73962780|NCT01546753|147461353|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73962781|NCT04247074|147461366|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73962782|NCT04247074|147461367|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73962783|NCT04247074|147461368|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73962784|NCT04247074|147461369|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73962785|NCT03337399|147461412|NON_INFERIORITY|Non-inferiority of stepped PC was established if the lower one-sided 95% confidence limit for the estimated difference in means was greater than the pre-specified margin of -4.5 points, which corresponds to the one-sided 5% significance level test against this margin.|Mean Difference (Final Values)|2.9|||<|0.05|ONE_SIDED|95.0|-0.01||||Regression, Linear|||The difference in week 24 means between groups was estimated using a linear regression model adjusted for baseline FACT-L score.|||-.01|<0.05
73962786|NCT03337399|147461413|NON_INFERIORITY|Pre-specified margin of -10%.|Estimated Proportions|-2.6|||<|0.15|ONE_SIDED|95.0|-10.4|||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15.|Regression, Linear|||Non-inferiority of stepped PC in the proportion reporting patient-clinician communication about end-of-life care at each patient's final follow-up assessment was evaluated using a binomial generalized linear model with identity link and a one-sided test against the pre-specified margin of -10%.|||-10.4|<0.15
73962787|NCT03337399|147461414|NON_INFERIORITY|Pre-specified margin of -7 days|Median Difference (Final Values)|-15.2||||0.15|ONE_SIDED|95.0|-25.1|||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15.|Regression, Linear|||Among patients who died, non-inferiority of stepped PC in the mean length of stay in hospice was assessed using linear regression and a one-sided test against the pre-specified margin of -7 days, based upon published quality metrics.|||-25.1|0.15
73962788|NCT03337399|147461415|SUPERIORITY||Median Difference (Final Values)|-2.3||||0.15|TWO_SIDED|95.0|-2.7|-1.8||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15|Regression, Linear|||The difference between groups in the mean number of outpatient PC visits per patient by week 24 was assessed using linear regression and a two-sided superiority test.||-1.8|-2.7|0.15
73962789|NCT00311363|147461419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.353||||0.0158||95.0|0.2|0.8||Model included terms for treatment group, randomization IRLS score (Week 24), and pooled study site|Regression, Logistic|||||0.8|0.2|0.0158
73962790|NCT03830866|147461452|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.174|TWO_SIDED|95.0|0.65|1.08|||Log Rank|||||1.08|0.65|0.174
73962791|NCT03830866|147461453|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.203|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||||1.10|0.64|0.203
73904878|NCT00395538|147340098|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.535||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.535
74084983|NCT03239496|147723614|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
73904879|NCT00395538|147340099|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.OS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
73930817|NCT03732638|147391490|SUPERIORITY||Risk Difference (RD)|7.6||||0.0438|TWO_SIDED|95.0|0.2|14.9|||Cochran-Mantel-Haenszel|||||14.9|0.2|0.0438
73930818|NCT03732638|147391491|SUPERIORITY||Mean Difference (Net)|-0.8||||0.0017|TWO_SIDED|95.0|-1.34|-0.31|||Mixed Models Analysis|||||-0.31|-1.34|0.0017
73930819|NCT03732638|147391492|SUPERIORITY||Mean Difference (Net)|-0.2||||0.3868|TWO_SIDED|95.0|-0.8|0.31||P-value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.|Mixed Models Analysis|||||0.31|-0.80|0.3868
73930820|NCT01034397|147391510|SUPERIORITY_OR_OTHER|||||||1||||||Wrist region: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
73930821|NCT01034397|147391510|SUPERIORITY_OR_OTHER|||||||0.026||||||2nd and 5th MCP joints: Tocilizumab versus placebo|t-test, 1 sided|||||||0.026
73930822|NCT01034397|147391510|SUPERIORITY_OR_OTHER|||||||1||||||Total synovitis score: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
73930823|NCT01034397|147391511|SUPERIORITY_OR_OTHER|||||||0.421||||||Percentage Change in OMERACT RAMRIS global score; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.421
73930824|NCT01034397|147391512|SUPERIORITY_OR_OTHER|||||||0.434||||||Absolute change in OMERACT RAMRIS global score; Placebo versus Tocilizumab|t-test, 1 sided|||||||0.434
73930825|NCT01034397|147391515|SUPERIORITY_OR_OTHER|||||||1||||||Change in Wrist region; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
73930826|NCT01034397|147391515|SUPERIORITY_OR_OTHER|||||||0.065||||||Change in 2nd to 5th MCP; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.065
73930827|NCT01034397|147391515|SUPERIORITY_OR_OTHER|||||||1||||||Change in Total synovitis; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
73930828|NCT01034397|147391517|SUPERIORITY_OR_OTHER|||||||1||||||Absolute Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
73930829|NCT01034397|147391518|SUPERIORITY_OR_OTHER|||||||1||||||Percentage Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
73930830|NCT01034397|147391521|SUPERIORITY_OR_OTHER|||||||0.266||||||Percentage Change in Bone oedema; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.266
73930831|NCT01034397|147391522|SUPERIORITY_OR_OTHER|||||||0.337||||||Absolute Change in Bone edema; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.337
73930832|NCT01034397|147391525|SUPERIORITY_OR_OTHER|||||||0.114||||||Percentage change in DCE-MRI EER (global); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.114
73930833|NCT01034397|147391526|SUPERIORITY_OR_OTHER|||||||0.239||||||Absolute Change in DCE-MRI EER; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.239
73930834|NCT01034397|147391529|SUPERIORITY_OR_OTHER|||||||0.271||||||Percentage change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.271
73930835|NCT01034397|147391530|SUPERIORITY_OR_OTHER|||||||0.37||||||Absolute change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.370
73930836|NCT01034397|147391533|SUPERIORITY_OR_OTHER|||||||1||||||Percentage and absolute change in DCE-MRI EER (wrist); Placebo versus Tocilizumab|t-test, 1 sided|||||||1.00
73930837|NCT01034397|147391538|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73930838|NCT01034397|147391541|SUPERIORITY_OR_OTHER|||||||0.067|||||||t-test, 1 sided|||||||0.067
73930839|NCT01034397|147391543|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
73962792|NCT03830866|147461455|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.091|TWO_SIDED|95.0|0.6|1.04|||Log Rank|||||1.04|0.60|0.091
73904880|NCT00395538|147340099|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
73904881|NCT00395538|147340099|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.328||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.328
73904882|NCT00395538|147340100|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.ES/BS values for both their baseline and year 1 biopsies.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
73904883|NCT00395538|147340100|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
73904884|NCT00395538|147340100|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.789||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.789
73930840|NCT01034397|147391545|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 1 sided|||||||0.002
74025245|NCT00457639|147603736|SUPERIORITY||Mean Difference (Net)|13.8||||0.42|TWO_SIDED|95.0|-19.7|61.1|||Mixed Models Analysis|||||61.1|-19.7|0.42
73930841|NCT01034397|147391547|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Baseline to Week 12|Friedman's T test|||||||<0.001
73930842|NCT01034397|147391547|SUPERIORITY_OR_OTHER|||||||0.5||||||Change from Baseline to Week 12|Friedman's T test|||||||0.500
73930843|NCT01034397|147391548|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 1 sided|||||||0.007
73930844|NCT01034397|147391551|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
73930845|NCT01034397|147391553|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 1 sided|||||||0.002
73930846|NCT01034397|147391555|SUPERIORITY_OR_OTHER|||||||0.118|||||||t-test, 1 sided|||||||0.118
73962793|NCT03830866|147461456|SUPERIORITY||Odds Ratio (OR)|1.15||||0.465|TWO_SIDED|95.0|0.794|1.657|||Regression, Logistic|||||1.657|0.794|0.465
74025246|NCT00457639|147603737|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.45|TWO_SIDED|95.0|-17.7|50.8|||Mixed Models Analysis|||||50.8|-17.7|0.45
74025247|NCT03528681|147603765|OTHER||Back-transformed mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.902|0.959|||Mixed Models Analysis|||Results are derived from a longitudinal model applied to log-transformed S-K measurements adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates. The back-transformation is to the original scale of the S-K measurement||0.959|0.902|<0.001
73930847|NCT01034397|147391557|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 1 sided|||||||1.00
73962794|NCT03830866|147461457|SUPERIORITY||Odds Ratio (OR)|1.11||||0.469|TWO_SIDED|95.0|0.833|1.487|||Regression, Logistic|||||1.487|0.833|0.469
73962795|NCT05113771|147461526|SUPERIORITY||LS Mean Difference|-4.4||||0.0056|TWO_SIDED|95.0|-7.6|-1.3|||MMRM|mixed model for repeated measures (MMRM) with imputation based on the missing at random (MAR) assumption was used.||||-1.3|-7.6|0.0056
73962796|NCT05113771|147461527|SUPERIORITY|||||||0.0189|||||||MMRM|||||||0.0189
73962797|NCT05113771|147461528|SUPERIORITY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||||||0.0026
73962798|NCT00130117|147461593|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||||||0.024
73962799|NCT00130117|147461593|SUPERIORITY|||||||0.049|||||||ANOVA|||||||0.049
74088346|NCT00595335|147730094|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 12 months.||||0.18
73904885|NCT00395538|147340101|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.AjAR values for both their baseline and year 1 biopsies.||||||0.651||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.651
73904886|NCT00395538|147340101|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.58||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.580
73930848|NCT01034397|147391559|SUPERIORITY_OR_OTHER|||||||0.437|||||||t-test, 1 sided|||||||0.437
73962800|NCT00130117|147461594|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.02|TWO_SIDED|||||"p value reflects treatment of leptin for on-treatment, n=4"|ANOVA|||||||0.02
73962801|NCT03122886|147461633|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.9|TWO_SIDED|95.0|0.12|6.37|||Log Rank|||||6.37|0.12|0.90
73962802|NCT03422276|147461634|SUPERIORITY||Mean Difference (Net)|-0.78||||0.44|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|t-test, 2 sided|t-test for independent samples, two-tailed, allocation ratio=1|Intervention mean minus control mean|It was calculated that 500 to 900 participants randomized in a 1:1 fashion between the two arms would have practically 100% power to detect an effect size of 0.5, and even a small sample size of 300 would have 80% power to detect a small effect size of 0.3 (800 to 900 would be 100% power).||||0.44
73962803|NCT03422276|147461635|SUPERIORITY||Mean Difference (Net)|1.63||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
74025248|NCT03528681|147603765|OTHER||Back-transformed mean difference|0.85|||<|0.001|TWO_SIDED|95.0|0.825|0.876|||Mixed Models Analysis|||Results are derived from a longitudinal model applied to log-transformed S-K measurements adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates. The back-transformation is to the original scale of the S-K measurement||0.876|0.825|<0.001
74025249|NCT03528681|147603770|OTHER|The analysis uses a generalized mixed model which includes a random intercept and logit link. The model includes all S-K data values collected at the scheduled visits between Days 8-29, dichotomized as normal and abnormal, as response variables, and baseline covariates. Placebo is the reference group.|Odds Ratio (OR)|3.8|||<|0.001|TWO_SIDED|95.0|2.17|6.67|||Mixed Models Analysis|||||6.67|2.17|<0.001
74084984|NCT03239496|147723615|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.0001
73930849|NCT01034397|147391560|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 1 sided|||||||1.00
73930850|NCT01034397|147391563|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 1 sided|||||||0.190
73930851|NCT01034397|147391565|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 1 sided|||||||0.051
73930852|NCT01018264|147391567|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.2||||0.53|TWO_SIDED||||||ANCOVA|Adjusted for baseline value|This represents the effect size between solifenacin and placebo.|||||0.53
73930853|NCT01018264|147391568|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.53||||0.01|TWO_SIDED||||||ANCOVA|||||||0.01
73962804|NCT05938413|147461699|NON_INFERIORITY|Non-inferiority test to compare viral suppression rate between month 3 and baseline.|Odds Ratio (OR)|3.01|||||TWO_SIDED|||||||||||||
73962805|NCT02576574|147461704|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.007|TWO_SIDED|95.0|0.54|0.93|||Log Rank|||||0.93|0.54|0.0070
73962806|NCT02576574|147461705|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0196|TWO_SIDED|95.0|0.52|0.98|||Log Rank|||||0.98|0.52|0.0196
74084985|NCT03239496|147723616|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.0001
73962807|NCT02576574|147461706|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1032|TWO_SIDED|95.0|0.67|1.09|||Log Rank|||||1.09|0.67|0.1032
73962808|NCT02576574|147461707|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.063|TWO_SIDED|95.0|0.59|1.07|||Log Rank|||||1.07|0.59|0.0630
73962809|NCT02576574|147461708|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0147|TWO_SIDED|95.0|0.62|0.98|||Log Rank|||||0.98|0.62|0.0147
73962810|NCT02576574|147461709|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1753|TWO_SIDED|95.0|0.67|1.15|||Log Rank|||||1.15|0.67|0.1753
73962811|NCT02576574|147461710|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0257|TWO_SIDED|95.0|0.66|1.0|||Log Rank|||||1.00|0.66|0.0257
73962812|NCT02576574|147461711|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0809|TWO_SIDED|95.0|0.66|1.07|||Log Rank|||||1.07|0.66|0.0809
73962813|NCT02576574|147461712|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1294|TWO_SIDED|95.0|0.78|1.07|||Log Rank|||||1.07|0.78|0.1294
73962814|NCT02576574|147461713|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2618|TWO_SIDED|95.0|0.79|1.13|||Log Rank|||||1.13|0.79|0.2618
73962815|NCT02576574|147461714|SUPERIORITY||Odds Ratio (OR)|1.41||||0.064|TWO_SIDED|95.0|0.91|2.18|||Cochran-Mantel-Haenszel|||||2.18|0.91|0.0640
73962816|NCT02576574|147461715|SUPERIORITY||Odds Ratio (OR)|1.23||||0.2217|TWO_SIDED|95.0|0.73|2.07|||Cochran-Mantel-Haenszel|||||2.07|0.73|0.2217
73962817|NCT02576574|147461716|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1912|TWO_SIDED|95.0|0.81|1.72|||Cochran-Mantel-Haenszel|||||1.72|0.81|0.1912
73962818|NCT02576574|147461717|SUPERIORITY||Odds Ratio (OR)|1.0||||0.4951|TWO_SIDED|95.0|0.64|1.57|||Cochran-Mantel-Haenszel|||||1.57|0.64|0.4951
73962819|NCT00253890|147461748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|35.7||||0.05||95.0|||||t-test, 2 sided|||Change in sleep quality was assessed by calculating gain scores. We used a 2-sided t-test to report mean change.||||.05
73962820|NCT01839331|147461772|SUPERIORITY|||||||0.004||||||Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.|ANOVA|||||||0.004
73962821|NCT01839331|147461772|SUPERIORITY|||||||0.017||||||Adjusted for injection volume and baseline WOMAC score.|ANOVA|||||||0.017
73962822|NCT01839331|147461772|SUPERIORITY|||||||0.093||||||Adjusted for injection volume and baseline WOMAC score.|ANOVA|||||||0.093
73962823|NCT01839331|147461773|SUPERIORITY|Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.||||||0.0442|||||||ANOVA|||||||0.0442
73962824|NCT01839331|147461774|SUPERIORITY|||||||0.4133||||||Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.|ANOVA|||||||0.4133
73855056|NCT00152477|147256882|SUPERIORITY||Difference of response rate|2.6|||=|0.783|TWO_SIDED|95.0|-13.5|18.8||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||18.8|-13.5|=0.783
73962825|NCT01839331|147461775|SUPERIORITY|||||||0.0122||||||Adjusted for injection volume (4 mL or 10 mL) and baseline PGA|ANOVA|||||||0.0122
73855057|NCT00152477|147256882|SUPERIORITY||Difference of response rate|10.2|||=|0.234|TWO_SIDED|95.0|-6.8|27.2||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \< 5.|Chi-squared|||||27.2|-6.8|=0.234
73855058|NCT00152477|147256882|SUPERIORITY||Difference of response rate|10.2|||=|0.228|TWO_SIDED|95.0|-6.8|27.2||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||27.2|-6.8|=0.228
73855059|NCT01005316|147256912|SUPERIORITY_OR_OTHER|||||||0.258|||||||Fisher Exact|||The p-value compares Cohort A: Non-Sensitized with Cohort B: Sensitized, Crossmatch Positive.||||0.2580
73855060|NCT01074463|147256948|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|109.18|||||TWO_SIDED|90.0|99.25|120.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||120.12|99.25|
73855061|NCT01074463|147256949|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.06|||||TWO_SIDED|90.0|98.73|109.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.68|98.73|
73855062|NCT01074463|147256950|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.34|||||TWO_SIDED|90.0|97.78|107.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.11|97.78|
73855063|NCT01734395|147256951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|4.56|<|0.0001|TWO_SIDED|95.0|-1.4262|-0.9467|||t-test, 2 sided|||||-0.9467|-1.4262|<.0001
73855064|NCT01734395|147256952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|STANDARD_DEVIATION|10.69|<|0.0001|TWO_SIDED|95.0|0.9188|2.0438|||t-test, 2 sided|||||2.0438|0.9188|<.0001
73855065|NCT01734395|147256953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_DEVIATION|2.43|<|0.0001|TWO_SIDED|95.0|-0.814|-0.5586|||t-test, 2 sided|||||-0.5586|-0.814|<.0001
73855066|NCT00758264|147256966|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.87|||||TWO_SIDED|95.0|0.72|1.05||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 1 antibody concentrations.||1.05|0.72|
73855067|NCT00758264|147256966|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.03|||||TWO_SIDED|95.0|0.84|1.26||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 4 antibody concentrations.||1.26|0.84|
73855068|NCT00758264|147256966|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.9|||||TWO_SIDED|95.0|0.74|1.1||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 5 antibody concentrations.||1.10|0.74|
73855069|NCT00758264|147256966|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.84|||||TWO_SIDED|95.0|0.66|1.07||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 6B antibody concentrations.||1.07|0.66|
73904887|NCT00395538|147340101|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.338||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.338
74025250|NCT03528681|147603770|OTHER||Odds Ratio (OR)|11.63|||<|0.001|TWO_SIDED|95.0|6.45|21.0|||Mixed Models Analysis|||The analysis uses a generalized mixed model which includes a random intercept and logit link. The model includes all S-K data values collected at the scheduled visits between Days 8-29, dichotomized as normal and abnormal, as response variables, and baseline covariates. Placebo is the reference group.||21.00|6.45|<0.001
74025251|NCT03528681|147603771|OTHER|The model included normokalaemia status (yes, no) on Day 29 as binary response variables, and baseline covariates. Placebo is the reference group.|Odds Ratio (OR)|2.54||||0.035|TWO_SIDED|95.0|1.07|6.05|||Regression, Logistic|||||6.05|1.07|0.035
74025252|NCT03528681|147603771|OTHER||Odds Ratio (OR)|6.25|||<|0.001|TWO_SIDED|95.0|2.56|15.27|||Regression, Logistic|||The model included normokalaemia status (yes, no) on Day 29 as binary response variables, and baseline covariates. Placebo is the reference group.||15.27|2.56|<0.001
74025253|NCT03528681|147603772|OTHER||Median Difference (Final Values)|5.72|||<|0.001|TWO_SIDED|95.0|3.13|8.31|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||8.31|3.13|<0.001
73904888|NCT00395538|147340102|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the year 1 biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.020
73930854|NCT01018264|147391569|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.35||||0.22|TWO_SIDED||||||ANCOVA|||||||0.22
73930855|NCT01018264|147391570|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.27||||0.47|TWO_SIDED||||||ANCOVA|||||||0.47
73930856|NCT01018264|147391571|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.11||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
73930857|NCT03915548|147391592|OTHER|Group by time interaction (difference in trajectory)||||||0.54||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,747)=0.88|||.54
73930858|NCT03915548|147391593|OTHER|Group by time interaction (difference in trajectory)||||||0.09||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,746.4)=2.64|||.09
73930859|NCT03915548|147391594|OTHER|Group by time interaction (difference in trajectory)||||||0.55||||||Adjusted|Mixed Models Analysis|Poisson model with log link; multiple-degree-of-freedom test|||F(3,717)=0.7|||.55
73930860|NCT03915548|147391595|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,394.7)=0.18|||.99
73930861|NCT03915548|147391596|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Overall score adjusted P = 0.99 Physical subscale adjusted P = 0.99 Social subscale adjusted P = 0.99 Emotional subscale adjusted P = 0.99 Functional subscale adjusted P = 0.99|Mixed Models Analysis|multiple-degree-of-freedom test|||"Group by time interaction:~Overall score: F(3,731.3)=0.03 Physical subscale: F(3,744.5)=0.23 Social subscale: F(3,740.6)=0.32 Emotional subscale: F(3,743)=0.46 Functional subscale: F(3,746.1)=0.3"|||0.99
73930862|NCT03915548|147391597|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Active coping adjusted P = 0.99 Planning adjusted P = 0.21 Positive reframing adjusted P = 0.99|Mixed Models Analysis|multiple-degrees-of-freedom test|||Active planning: F(3,746)=0.8 Planning: F(3,744.8)=2.93 Positive reframing = F(3,742)=0.21|||0.99
73930863|NCT03915548|147391598|OTHER|Group by time interaction (difference in trajectory)||||||0.02|||||||Mixed Models Analysis|multiple-degrees-of-freedom test|||Disengagement: F(3,741.2)=5.09 Reengagement: F(3,745.7)=0.81|||0.02
73930864|NCT03915548|147391599|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Anxiety adjusted P = 0.99 Depression adjusted P = 0.99|Mixed Models Analysis|multiple-degrees-of-freedom test|||Anxiety: F(3,737.5)=0.17 Depression: F(3,733.6)=0.85|||0.99
73930865|NCT03915548|147391600|SUPERIORITY||Cohen's d|0.26||||0.09|TWO_SIDED|95.0|-0.01|0.54||Importance subscale: Adjusted P = .09 Performance subscale: Adjusted P = \<.001 Satisfaction subscale: Adjusted P = \<.001|Mixed Models Analysis|multiple-degrees-of-freedom test|Importance subscale: Cohen's d = 0.26 (-.01, 0.54) Performance subscale: Cohen's d = 0.60 (0.32, 0.87) Satisfaction subscale: Cohen's d = 0.76 (0.48, 1.02)|||0.54|-.01|.09
73930866|NCT03217136|147391601|OTHER|The Miettinen \& Nurminen method was used.|Difference in Percentage|18.1|||||TWO_SIDED|95.0|-2.6|41.1||||||Difference in Percentage (C/T+MTZ minus MERO)||41.1|-2.6|
73930867|NCT03217136|147391602|OTHER|The Miettinen \& Nurminen method was used.|Difference in Percentage|2.9|||||TWO_SIDED|95.0|-12.9|9.9||||||Difference in Percentage (C/T+MTZ minus MERO)||9.9|-12.9|
73930868|NCT03217136|147391603|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-14.3|||||TWO_SIDED|95.0|-26.67|4.93||||||Difference in Percentage (C/T+MTZ minus MERO)||4.93|-26.67|
73930869|NCT03217136|147391604|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-19.1|||||TWO_SIDED|95.0|-30.18|-2.89||||||Difference in Percentage (C/T+MTZ minus MERO)||-2.89|-30.18|
74025254|NCT03528681|147603772|OTHER||Mean Difference (Final Values)|11.14|||<|0.001|TWO_SIDED|95.0|8.57|13.71|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||13.71|8.57|<0.001
73904889|NCT00395538|147340102|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the years 2 and 4 (combined) biopsy.||||||0.11||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.110
73904890|NCT00395538|147340102|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.764||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.764
73904891|NCT00395538|147340103|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the year 1 biopsy.||||||0.227||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.227
73904892|NCT00395538|147340103|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the years 2 and 4 (combined) biopsy.||||||0.194||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.194
73904893|NCT00395538|147340103|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.434||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.434
73962826|NCT03752151|147461776|SUPERIORITY||||||<|0.001|||||||McNemar|||The null hypothesis was that the probability of meeting the endpoint (Atrioventricular synchrony \>70%) was the same in MARVEL 2 Monitor Mode and MARVEL 2 Adaptive Mode. A sample size of 35 participants with a predominant rhythm of 3rd degree atrioventricular block and normal sinus function provided \>90% power at a type I error rate of 0.05 assuming the proportion of patients meeting the endpoint in one mode, but not the other exceeded 50% and 90% of these pairs favored the Adaptive mode.||||<0.001
74025255|NCT03528681|147603775|OTHER||Mean Difference (Final Values)|-105.248|||<|0.001|TWO_SIDED|95.0|-161.293|-49.203|||Mixed Models Analysis|||S-Aldo Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||-49.203|-161.293|<0.001
74025256|NCT03528681|147603775|OTHER||Median Difference (Final Values)|-137.267|||<|0.001|TWO_SIDED|95.0|-192.596|-81.937|||Mixed Models Analysis|||S-Aldo Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||-81.937|-192.596|<0.001
74025257|NCT03528681|147603775|OTHER||Mean Difference (Final Values)|0.014||||0.839|TWO_SIDED|95.0|-0.12|0.147|||Mixed Models Analysis|||P-Renin Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||0.147|-0.120|0.839
73904894|NCT00395538|147340104|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the year 1 biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
74025258|NCT03528681|147603775|OTHER||Mean Difference (Final Values)|-0.062||||0.355|TWO_SIDED|95.0|-0.195|0.07|||Mixed Models Analysis|||P-Renin Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||0.070|-0.195|0.355
74025259|NCT03528681|147603777|OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.27|0.57|||Regression, Cox|||The model included time to reoccurrence of hyperkalaemia as response variable (event: hyperkalaemia or discontinue treatment in RTP due to high S-K levels), baseline eGFR, OLP and RTP baseline S-K values as well as age (\< 55, 55-64, \> 64 years) and baseline binary indicators for RAASi, chronic kidney disease, heart failure, and diabetes mellitus as covariates. Placebo is the reference group||0.57|0.27|<0.001
74088347|NCT00595335|147730095|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.||||0.85
73904895|NCT00395538|147340104|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
73904896|NCT00395538|147340104|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.787||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.787
73904897|NCT00395538|147340105|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the year 1 biopsy.||||||0.082||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.082
73904898|NCT00395538|147340105|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the years 2 and 4 (combined) biopsy.||||||0.057||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.057
73904899|NCT00395538|147340105|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.547||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.547
73904900|NCT00395538|147340106|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the baseline and the year 1 biopsy.||||||0.922||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.922
73904901|NCT00395538|147340106|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 and the years 2 and 4 (combined) biopsy.||||||0.342||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.342
73962827|NCT03752151|147461777|SUPERIORITY||proportion expressed as a percentage|100.0|||<|0.001|TWO_SIDED|95.0|95.2|100.0|||Exact binomial test|||The null hypothesis is that 87% or fewer participants will achieve the endpoint. The alternative hypothesis is that more than 87% of participants will achieve the endpoint. A sample size of 70 participants provides at least 90% power to test the null hypothesis assuming the true rate of meeting the endpoint in the population is 98% at a type I error rate of 2.5%.||100|95.2|<0.001
74088348|NCT01131299|147730140|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||The minimum sample size to detect an 8 mg/dl change in total plasma cholesterol between the placebo and alpha cyclodextrin periods is 62 subjects. The power is 80% by using the normal approximation to a one-sample (paired) two-tail t-test at an alpha of 0.05.||||0.82
73904902|NCT00395538|147340106|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.449||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.449
73904903|NCT00859027|147340139|OTHER|||||||0.004|||||||One way ANOVA|||Percent change in femoral neck BMD from baseline||||0.004
73904904|NCT00859027|147340139|OTHER|||||||0.001|||||||One way ANOVA|||Percent change in total hip BMD from baseline||||0.001
73904905|NCT00859027|147340139|OTHER|||||||0.04|||||||One way ANOVA|||Percent change in lumbar spine BMD from baseline||||0.04
74088349|NCT01131299|147730141|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
73904906|NCT00859027|147340139|OTHER||||||<|0.01|||||||ANOVA|||Between group difference of percent change for the femoral neck BMD||||<0.01
73904907|NCT00859027|147340139|OTHER||||||<|0.01|||||||ANOVA|||Between group difference of percent change for total hip BMD||||<0.01
73904908|NCT00859027|147340140|OTHER|||||||0.015|||||||ANOVA|||Between group difference of percent change for NTX||||0.015
73904909|NCT00859027|147340140|OTHER|||||||0.01|||||||ANOVA|||Between group difference of percent change for CTX||||0.01
73904910|NCT05063318|147340145|SUPERIORITY||Least-squares geometric mean ratio|272.73|||||TWO_SIDED|90.0|213.22|348.86|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||348.86|213.22|
73904911|NCT05063318|147340146|SUPERIORITY||Least-squares geometric mean ratio|236.73|||||TWO_SIDED|90.0|177.35|316.0|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||316.00|177.35|
73904912|NCT05063318|147340147|SUPERIORITY||least-squares geometric mean ratio.|115.51|||||TWO_SIDED|90.0|100.07|133.33|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||133.33|100.07|
73962828|NCT03752151|147461778|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.002|TWO_SIDED|95.0|0.7|2.7|||t-test, 2 sided|Paired t-test since each participant had LVOT VTI measurements in MARVEL 2 Adaptive and Monitor modes||The null hypothesis is that the mean LVOT VTI during MARVEL 2 Adaptive mode equals the mean LVOT VTI during MARVEL 2 Monitor mode. A sample size of 35 participants with paired LVOT VTI measurements provides 89% power at a type I error rate of 5% to reject the null hypothesis assuming the true difference in LVOT VTI is 2.1 cm with a standard deviation of 3.8 cm.||2.7|0.7|0.002
73962829|NCT03074331|147461867|SUPERIORITY|||||||0.009|||||||2-sided exact 1-sample binomial test|||The SVR12 rate was compared to the pre-specified performance goal of 85% by using a two-sided exact one-sample binomial test at the 0.05 significance level.||||0.009
73962830|NCT01985334|147461883|SUPERIORITY_OR_OTHER|||||||0.018|||||||linear mixed model|||||||0.0180
73904913|NCT05063318|147340148|SUPERIORITY||Least-squares geometric mean ratio.|217.57|||||TWO_SIDED|90.0|151.81|311.82|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence (TR or RT) as fixed effects, and patient (sequence) as a random effect.||||311.82|151.81|
73904914|NCT05063318|147340149|SUPERIORITY||Least-squares geometric mean ratio|36.67|||||TWO_SIDED|90.0|28.66|46.9|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||46.9|28.66|
73904915|NCT05063318|147340150|SUPERIORITY||Least-squares geometric mean ratio|99.89|||||TWO_SIDED|90.0|65.76|151.74|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||151.74|65.76|
73904916|NCT01659658|147340151|SUPERIORITY||Odds Ratio (OR)|1.1|||=|0.7623|TWO_SIDED|95.0|0.6|2.01||P-value was calculated from the unstratified Cochran-Mantel-Haenszel (CMH) test to compare hematologic response rate between the treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was derived from a logistic regression model with treatment and 95% confidence interval (CI) for the odds ratio was based on the Wald approximation.|Statistical analysis was planned to be collected and analyzed in a combined manner for the non-ixazomib arm groups versus ixazomib group in this outcome measure.||2.01|0.60|=0.7623
73904917|NCT01659658|147340152|SUPERIORITY||Odds Ratio (OR)|0.75|||=|0.351|TWO_SIDED|95.0|0.41|1.38||P-value was calculated from the unstratified CMH test to make comparisons between the 2 treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was derived from a logistic regression model with treatment and 95% CI for the odds ratio was based on the Wald approximation.|||1.38|0.41|=0.3510
73962831|NCT01985334|147461884|NON_INFERIORITY_OR_EQUIVALENCE|"H0: Glycopyrronium (50 μg o.d.) \[randomized group B2\] was inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~H0: μFEV1, NVA237 - μFEV1, LABA and/or LAMA \< -40 mL Ha: Glycopyrronium (50 μg o.d.) \[randomized group B2\] is non-inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~Ha: μFEV1, NVA237 - μFEV1, LABA and/or LAMA ≥ -40 mL"|||||<|0.0001|||||||linear mixed model|||||||<0.0001
73904918|NCT01659658|147340154|SUPERIORITY||Hazard Ratio (HR)|0.82|||=|0.389|TWO_SIDED|95.0|0.52|1.29||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.29|0.52|=0.389
73904919|NCT01659658|147340155|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.135|TWO_SIDED|95.0|0.52|1.09||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.09|0.52|=0.135
73904920|NCT01659658|147340156|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2421|TWO_SIDED|95.0|0.48|1.21||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.21|0.48|0.2421
73904921|NCT01659658|147340157|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.036|TWO_SIDED|95.0|0.39|0.97||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.97|0.39|=0.036
73904922|NCT01659658|147340158|SUPERIORITY||Odds Ratio (OR)|1.69|||=|0.226|TWO_SIDED|95.0|0.72|3.99||P-value was calculated from the unstratified CMH test to compare vital organ response rate between the 2 treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was calculated from a logistic regression model with treatment and 95% CI for the odds ratio was based on the Wald approximation.|||3.99|0.72|=0.2260
73904923|NCT01659658|147340159|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.163|TWO_SIDED|95.0|0.52|1.12||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|||1.12|0.52|=0.163
73962832|NCT01985334|147461885|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
73962833|NCT01985334|147461886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
73962834|NCT01985334|147461887|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
73962835|NCT01985334|147461888|NON_INFERIORITY_OR_EQUIVALENCE|A difference of 0.6 points in TDI was adopted as boundary for non-inferiority|||||<|0.0001|||||||linear mixed model|||||||<0.0001
73962836|NCT01985334|147461889|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
73904924|NCT01659658|147340162|SUPERIORITY||Hazard Ratio (HR)|0.68|||=|0.025|TWO_SIDED|95.0|0.49|0.96||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.96|0.49|=0.025
73904925|NCT01659658|147340163|SUPERIORITY||Hazard Ratio (HR)|0.58|||=|0.01|TWO_SIDED|95.0|0.38|0.88||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.88|0.38|=0.010
73904926|NCT01083485|147340172|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||A P value was not part of the analysis plan. A within SD 1.7, and expected treatment difference of 0 and a non-inferiority margin was -1.0 meaning that OXN PR can be one unit inferior to OXY PR and still be considered non-inferior.|ANCOVA|The primary efficacy endpoint was analysed on the PP data using a mixed-model repeat measure analysis of covariance RMANCOVA.||The sample size was calculated for a significance level of 2.5% (1 sided) with 90% power. A within SD 1.7, and expected treatment difference of 0 and a non-inferiority margin of 1.0 were assumed.||0.3|-0.5|
73904927|NCT03607422|147340199|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|59.6|||<|0.001|TWO_SIDED|95.0|53.1|66.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||66.2|53.1|<0.001
73904928|NCT03607422|147340199|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|46.9|||<|0.001|TWO_SIDED|95.0|39.9|53.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.9|39.9|<0.001
73904929|NCT03607422|147340200|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.4|||<|0.001|TWO_SIDED|95.0|41.0|53.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.7|41.0|<0.001
73904930|NCT03607422|147340200|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|34.0|||<|0.001|TWO_SIDED|95.0|27.8|40.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||40.2|27.8|<0.001
73904931|NCT03607422|147340201|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.4|||<|0.001|TWO_SIDED|95.0|43.8|57.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.1|43.8|<0.001
73904932|NCT03607422|147340201|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|32.6|||<|0.001|TWO_SIDED|95.0|25.8|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||39.4|25.8|<0.001
73904933|NCT03607422|147340202|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|46.7|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.4|46.7|<0.001
73904934|NCT03607422|147340202|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|36.9|||<|0.001|TWO_SIDED|95.0|30.6|43.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.3|30.6|<0.001
73962837|NCT01985334|147461890|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
73962838|NCT03903822|147461904|SUPERIORITY||Least square (LS) mean difference|-13.9|STANDARD_ERROR_OF_MEAN|11.04||0.104|TWO_SIDED|90.0|-32.1|4.3|||ANCOVA|||Analysis of covariance (ANCOVA) contained fixed factors of treatment and baseline value.||4.3|-32.1|0.1040
73962839|NCT03903822|147461904|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|11.0||0.0334|TWO_SIDED|90.0|-38.3|-2.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-2.1|-38.3|0.0334
74088350|NCT01131299|147730142|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
73904935|NCT03607422|147340203|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.0|||<|0.001|TWO_SIDED|95.0|50.9|63.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||63.0|50.9|<0.001
73904936|NCT03607422|147340203|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|38.9|51.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||51.4|38.9|<0.001
73904937|NCT03607422|147340204|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.4|||<|0.001|TWO_SIDED|95.0|34.2|46.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.5|34.2|<0.001
73904938|NCT03607422|147340204|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|29.4|||<|0.001|TWO_SIDED|95.0|23.5|35.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||35.3|23.5|<0.001
73904939|NCT03607422|147340205|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|14.9|||<|0.001|TWO_SIDED|95.0|10.6|19.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||19.3|10.6|<0.001
73930870|NCT03217136|147391605|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-11.2|||||TWO_SIDED|95.0|-23.66|9.61||||||Difference in Percentage (C/T+MTZ minus MERO)||9.61|-23.66|
73930871|NCT03217136|147391606|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-16.3|||||TWO_SIDED|95.0|-27.59|1.39||||||Difference in Percentage (C/T+MTZ minus MERO)||1.39|-27.59|
73930872|NCT03192150|147391607|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was two-sided and performed using a significance (alpha) level of 0.05.|||||<|0.0001||||||P-values were from a Chi-Square test (with continuity correction) of differences between treatments in the proportion of participants with ACC Grade 0 who did not receive rescue medication versus all other grades combined.|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||||||< 0.0001
73930873|NCT03192150|147391608|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.311||||0.0054|TWO_SIDED|95.0|1.311|4.074||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 1||4.074|1.311|0.0054
73930874|NCT03192150|147391608|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.581|||<|0.0001|TWO_SIDED|95.0|1.967|6.519||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 8||6.519|1.967|< 0.0001
73930875|NCT03192150|147391608|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.503|||<|0.0001|TWO_SIDED|95.0|1.909|6.426||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 15||6.426|1.909|< 0.0001
73930876|NCT03192150|147391608|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.659|||<|0.0001|TWO_SIDED|95.0|1.987|6.736||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 18||6.736|1.987|< 0.0001
73930877|NCT03192150|147391608|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.952||||0.0008|TWO_SIDED|95.0|1.596|5.462||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 29||5.462|1.596|0.0008
73930878|NCT05446909|147391625|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
73930879|NCT05446909|147391626|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
73904940|NCT03607422|147340205|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|6.7|||<|0.001|TWO_SIDED|95.0|3.4|10.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||10.0|3.4|<0.001
73904941|NCT03607422|147340206|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|7.2|||<|0.001|TWO_SIDED|95.0|3.8|10.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||10.5|3.8|<0.001
73904942|NCT03607422|147340207|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|8.6|||<|0.001|TWO_SIDED|95.0|4.3|12.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||12.9|4.3|<0.001
73904943|NCT03607422|147340208|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-23.1|||<|0.001|TWO_SIDED|95.0|-28.4|-17.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-17.8|-28.4|<0.001
73904944|NCT03607422|147340208|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-22.4|||<|0.001|TWO_SIDED|95.0|-27.8|-16.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-16.9|-27.8|<0.001
73904945|NCT03607422|147340209|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|49.8|||<|0.001|TWO_SIDED|95.0|42.2|57.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.3|42.2|<0.001
73904946|NCT03607422|147340209|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|30.1|45.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.8|30.1|<0.001
73904947|NCT03607422|147340210|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|51.8|||<|0.001|TWO_SIDED|95.0|44.4|59.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.1|44.4|<0.001
73904948|NCT03607422|147340210|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|35.9|||<|0.001|TWO_SIDED|95.0|28.2|43.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.5|28.2|<0.001
73904949|NCT03607422|147340211|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.3|||<|0.001|TWO_SIDED|95.0|46.0|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.6|46.0|<0.001
73904950|NCT03607422|147340211|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.3|||<|0.001|TWO_SIDED|95.0|32.7|48.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||48.0|32.7|<0.001
73930880|NCT05446909|147391627|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
73930881|NCT05446909|147391628|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73930882|NCT05446909|147391629|SUPERIORITY|||||||0.754|||||||ANOVA|||||||0.754
73930883|NCT05446909|147391630|SUPERIORITY|||||||0.985|||||||ANOVA|||||||0.985
74088351|NCT01131299|147730143|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
73855070|NCT00758264|147256966|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.84|1.2||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 7F antibody concentrations.||1.20|0.84|
73855071|NCT00758264|147256966|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.78|1.14||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 9V antibody concentrations.||1.14|0.78|
73855072|NCT00758264|147256966|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.78|1.23||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 14 antibody concentrations.||1.23|0.78|
73855073|NCT00758264|147256966|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.52|||||TWO_SIDED|95.0|0.41|0.67||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 18C antibody concentrations.||0.67|0.41|
73855074|NCT00758264|147256966|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.86|||||TWO_SIDED|95.0|0.68|1.08||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 19F antibody concentrations.||1.08|0.68|
73855075|NCT00758264|147256966|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.07|||||TWO_SIDED|95.0|0.83|1.38||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 23F antibody concentrations.||1.38|0.83|
73855076|NCT00758264|147256967|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.93|||||TWO_SIDED|95.0|-1.09|8.15||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA).||8.15|-1.09|
73855077|NCT00758264|147256967|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.68|||||TWO_SIDED|95.0|-2.11|6.22||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC).||6.22|-2.11|
73855078|NCT00758264|147256967|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.25|||||TWO_SIDED|95.0|-0.94|6.76||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135).||6.76|-0.94|
73904951|NCT03607422|147340212|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|54.8|||<|0.001|TWO_SIDED|95.0|47.2|62.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||62.3|47.2|<0.001
73930884|NCT05446909|147391631|SUPERIORITY|||||||0.877|||||||ANOVA|||||||0.877
73930885|NCT00261716|147391646|SUPERIORITY_OR_OTHER|||||||0.33|||||||Chi-squared|1 degree of freedom||Intent to treat analysis||||.33
73904952|NCT03607422|147340212|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.3|||<|0.001|TWO_SIDED|95.0|32.3|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||48.3|32.3|<0.001
73904953|NCT03607422|147340213|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|42.8|58.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||58.5|42.8|<0.001
73904954|NCT03607422|147340213|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|29.5|46.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.3|29.5|<0.001
73904955|NCT03607422|147340214|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|18.1|||<|0.0001|TWO_SIDED|95.0|13.5|22.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||22.7|13.5|<0.0001
73962840|NCT03903822|147461904|SUPERIORITY||LS Mean Difference|-25.6|STANDARD_ERROR_OF_MEAN|10.75||0.0086|TWO_SIDED|90.0|-43.3|-8.0|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-8.0|-43.3|0.0086
73904956|NCT03607422|147340214|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|13.4|||<|0.001|TWO_SIDED|95.0|9.2|17.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||17.6|9.2|<0.001
73904957|NCT03607422|147340215|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-49.45|STANDARD_ERROR_OF_MEAN|3.364|<|0.001|TWO_SIDED|95.0|-56.05|-42.84|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-42.84|-56.05|<0.001
73904958|NCT03607422|147340215|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-34.16|STANDARD_ERROR_OF_MEAN|3.386|<|0.001|TWO_SIDED|95.0|-40.81|-27.51|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-27.51|-40.81|<0.001
73962841|NCT03903822|147461904|SUPERIORITY||LS Mean Difference|-23.5|STANDARD_ERROR_OF_MEAN|10.93||0.0158|TWO_SIDED|90.0|-41.5|-5.5|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-5.5|-41.5|0.0158
73904959|NCT03607422|147340216|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-50.14|STANDARD_ERROR_OF_MEAN|3.127|<|0.001|TWO_SIDED|95.0|-56.28|-44.0|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-44.00|-56.28|<0.001
73962842|NCT03903822|147461904|SUPERIORITY||LS Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|8.11||0.0879|TWO_SIDED|90.0|-24.3|2.4|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||2.4|-24.3|0.0879
73962843|NCT03903822|147461904|SUPERIORITY||LS Mean Difference|-27.4|STANDARD_ERROR_OF_MEAN|8.11||0.0004|TWO_SIDED|90.0|-40.7|-14.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-14.1|-40.7|0.0004
73962844|NCT03903822|147461905|SUPERIORITY||Risk Difference (RD)|18.9||||0.0244|TWO_SIDED|90.0|2.4|34.7|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||34.7|2.4|0.0244
73962845|NCT03903822|147461905|SUPERIORITY||Risk Difference (RD)|22.5||||0.0113|TWO_SIDED|90.0|4.8|38.6|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||38.6|4.8|0.0113
73962846|NCT03903822|147461905|SUPERIORITY||Risk Difference (RD)|29.7||||0.0018|TWO_SIDED|90.0|11.0|45.7|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||45.7|11.0|0.0018
74025260|NCT03528681|147603777|OTHER||Hazard Ratio (HR)|0.16|||<|0.001|TWO_SIDED|95.0|0.1|0.25|||Regression, Cox|||The model included time to reoccurrence of hyperkalaemia as response variable (event: hyperkalaemia or discontinue treatment in RTP due to high S-K levels), baseline eGFR, OLP and RTP baseline S-K values as well as age (\< 55, 55-64, \> 64 years) and baseline binary indicators for RAASi, chronic kidney disease, heart failure, and diabetes mellitus as covariates. Placebo is the reference group||0.25|0.10|<0.001
73904960|NCT03607422|147340216|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-39.62|STANDARD_ERROR_OF_MEAN|3.139|<|0.001|TWO_SIDED|95.0|-45.79|-33.46|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.46|-45.79|<0.001
73904961|NCT03607422|147340217|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|54.7|||<|0.001|TWO_SIDED|95.0|47.7|61.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||61.7|47.7|<0.001
73904962|NCT03607422|147340217|SUPERIORITY||Adjusted Response Rate Difference|42.1|||<|0.001|TWO_SIDED|95.0|34.5|49.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.||49.8|34.5|<0.001
73904963|NCT03607422|147340218|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|49.0|||<|0.001|TWO_SIDED|95.0|41.4|56.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.5|41.4|<0.001
73904964|NCT03607422|147340218|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|42.8||||0.002|TWO_SIDED|95.0|35.0|50.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.6|35.0|0.002
73904965|NCT03607422|147340219|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-40.01|STANDARD_ERROR_OF_MEAN|2.949|<|0.001|TWO_SIDED|95.0|-45.8|-34.22|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-34.22|-45.80|<0.001
73904966|NCT03607422|147340219|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-29.47|STANDARD_ERROR_OF_MEAN|2.941|<|0.001|TWO_SIDED|95.0|-35.24|-23.69|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.||||-23.69|-35.24|<0.001
73930886|NCT00261716|147391647|SUPERIORITY_OR_OTHER|||||||0.75|||||||t-test, 2 sided|degrees of freedom=36||intent to treat analysis||||.75
73930887|NCT00261716|147391648|SUPERIORITY_OR_OTHER|||||||0.41|||||||t-test, 2 sided|degrees of freedom=17||||||.41
73930888|NCT00261716|147391649|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|Fishers exact= 1.0; one degree of freedom||intent to treat --all participants who obtained at least one job||||>.05
73930889|NCT00261716|147391649|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>.05
74025261|NCT01416181|147603785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.2866|TWO_SIDED|95.0|0.66|1.13|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 2 years||1.13|0.66|0.2866
74025262|NCT01416181|147603785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.753|TWO_SIDED|95.0|0.74|1.53|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS||1.53|0.74|0.7530
74025263|NCT01416181|147603785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9137|TWO_SIDED|95.0|0.74|1.3|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW||1.30|0.74|0.9137
73855079|NCT00758264|147256967|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.18|4.6||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY).||4.6|-2.18|
73855080|NCT01194089|147256990|SUPERIORITY_OR_OTHER|||||||0.828|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for the postoperative opioid use during the postanesthesia care unit (PACU) stay, using a one tailed P value.||||0.828
73855081|NCT01194089|147256990|SUPERIORITY_OR_OTHER|||||||0.752|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for the first 24 hours postoperatively, using a one tailed P value.||||0.752
73855082|NCT01194089|147256991|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Chi-squared|||Comparison between the arms for antiemetic medication use in the PACU.||||0.002
73855083|NCT01194089|147256992|SUPERIORITY_OR_OTHER|||||||0.354|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score on admission.||||0.354
73855084|NCT01194089|147256992|SUPERIORITY_OR_OTHER|||||||0.492|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 30 minutes.||||0.492
73855085|NCT01194089|147256992|SUPERIORITY_OR_OTHER|||||||0.809|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 60 minutes.||||0.809
73855086|NCT01194089|147256992|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at discharge.||||0.381
73930890|NCT00261716|147391650|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mixed Models Analysis|employment status effect- F(1,12)=..85||Intent to treat analysis||||.37
73855087|NCT01106651|147256999|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.708|-0.436|||ANCOVA|||||-0.436|-0.708|<0.001
73855088|NCT01106651|147256999|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.841|-0.566|||ANCOVA|||||-0.566|-0.841|<0.001
73855089|NCT01106651|147257000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001||95.0|1.93|4.56|||Regression, Logistic|||||4.56|1.93|<0.001
73855090|NCT01106651|147257000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48|||<|0.001||95.0|2.89|6.95|||Regression, Logistic|||||6.95|2.89|<0.001
73855091|NCT01106651|147257001|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-25.5|STANDARD_ERROR_OF_MEAN|3.147|<|0.001|TWO_SIDED|95.0|-31.68|-19.32|||ANCOVA|||||-19.32|-31.68|<0.001
73855092|NCT01106651|147257001|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-27.7|STANDARD_ERROR_OF_MEAN|3.179|<|0.001|TWO_SIDED|95.0|-33.97|-21.49|||ANCOVA|||||-21.49|-33.97|<0.001
73855093|NCT01106651|147257002|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.8|-1.7|||ANCOVA|||||-1.7|-2.8|<0.001
73855094|NCT01106651|147257002|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.5|-2.4|||ANCOVA|||||-2.4|-3.5|<0.001
73855095|NCT01106651|147257003|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.379|<|0.001|TWO_SIDED|95.0|-2.339|-0.842|||ANCOVA|||||-0.842|-2.339|<0.001
73855096|NCT01106651|147257003|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.371|<|0.001|TWO_SIDED|95.0|-2.833|-1.368|||ANCOVA|||||-1.368|-2.833|<0.001
73855097|NCT01106651|147257004|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.305|<|0.001|TWO_SIDED|95.0|-1.633|-0.428|||ANCOVA|||Region percent total fat||-0.428|-1.633|<0.001
73855098|NCT01106651|147257004|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.772|-0.587|||ANCOVA|||Region percent total fat||-0.587|-1.772|<0.001
73855099|NCT01106651|147257005|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.316||0.001|TWO_SIDED|95.0|-1.677|-0.43|||ANCOVA|||||-0.430|-1.677|0.001
73855100|NCT01106651|147257005|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.311|<|0.001|TWO_SIDED|95.0|-1.812|-0.584|||ANCOVA|||||-0.584|-1.812|<0.001
73855101|NCT01106651|147257006|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.63|STANDARD_ERROR_OF_MEAN|1.134|<|0.001|TWO_SIDED|95.0|-6.854|-2.401|||ANCOVA|||||-2.401|-6.854|<0.001
73855102|NCT01106651|147257006|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|1.147|<|0.001|TWO_SIDED|95.0|-10.14|-5.641|||ANCOVA|||||-5.641|-10.14|<0.001
73855103|NCT01106651|147257007|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|3.7||0.194|TWO_SIDED|95.0|-12.1|2.5|||ANCOVA|||||2.5|-12.1|0.194
73855104|NCT01106651|147257007|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|3.7||0.846|TWO_SIDED|95.0|-6.6|8.1|||ANCOVA|||||8.1|-6.6|0.846
73855105|NCT01106651|147257008|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.6|7.9|||ANCOVA|||||7.9|2.6|<0.001
73855106|NCT01106651|147257008|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.0|7.4|||ANCOVA|||||7.4|2.0|<0.001
73855107|NCT01106651|147257009|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.4|0.8|||ANCOVA|||||0.8|-0.4|
73855108|NCT01106651|147257009|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||||0.3|-0.9|
73930891|NCT00261716|147391650|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|time effect F(1,54)=.2.05||||||.16
73930892|NCT00261716|147391650|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mixed Models Analysis|employment status X time effect F (1,54)=.. 24||||||.63
73930893|NCT00261716|147391651|SUPERIORITY_OR_OTHER|||||||0.62|||||||Mixed Models Analysis|employment status effect F(1,12)=.26||intent to treat analysis||||.62
73904967|NCT03607422|147340220|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|44.5|||<|0.001|TWO_SIDED|95.0|35.0|54.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||54.1|35.0|<0.001
73855109|NCT01106651|147257010|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.9|0.4|||ANCOVA|||||0.4|-0.9|
73855110|NCT01106651|147257010|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-1.0|0.3|||ANCOVA|||||0.3|-1.0|
73855111|NCT01106651|147257011|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.3|1.0|||ANCOVA|||||1.0|-0.3|
73855112|NCT01106651|147257011|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|
73855113|NCT01106651|147257012|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||||-0.0|-0.8|
73855114|NCT01106651|147257012|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||||-0.1|-0.9|
73855115|NCT04590404|147257013|SUPERIORITY||Odds Ratio (OR)|1.18||||0.461|TWO_SIDED|95.0|0.76|1.82|||Regression, Logistic|Adjusted for arm, randomization strata (cigarettes/day (CPD), insurance category, cardiac admission, NMR category), \& plan to quit after discharge||The primary outcome was biochemically-verified self-reported 7-day point prevalence abstinence (7dPPA) at 6 months. We modeled outcomes using logistic regression adjusted for randomization stratification factors and plan to quit (stay quit vs. try).||1.82|0.76|0.461
73904968|NCT03607422|147340220|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|34.4|||<|0.001|TWO_SIDED|95.0|24.7|44.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.2|24.7|<0.001
73904969|NCT03607422|147340221|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|33.3|||<|0.001|TWO_SIDED|95.0|26.9|39.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||39.8|26.9|<0.001
73904970|NCT03607422|147340221|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|19.1|||<|0.001|TWO_SIDED|95.0|13.3|24.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||24.9|13.3|<0.001
73930894|NCT00261716|147391651|SUPERIORITY_OR_OTHER|||||||0.65|||||||Mixed Models Analysis|time effect F (1,58)=.21 ,.||||||.65
73930895|NCT00261716|147391651|SUPERIORITY_OR_OTHER|||||||0.81|||||||Mixed Models Analysis|employment status X time effect F(1,58)=.06||||||.81
73930896|NCT00261716|147391652|SUPERIORITY_OR_OTHER|||||||0.19|||||||Mixed Models Analysis|employment status effect F(1,12)=1.95,||Intent to treat analysis||||.19
73930897|NCT00261716|147391652|SUPERIORITY_OR_OTHER|||||||0.09|||||||Mixed Models Analysis|time effect (1.54)=2.99,||||||.09
73855116|NCT03641716|147257053|OTHER||Mean Difference (Net)|3.67|STANDARD_DEVIATION|2.08|||TWO_SIDED|||||||||||||
73855117|NCT03641716|147257054|OTHER||Effect Size - Cohen's d|-0.01|||||TWO_SIDED|95.0|-0.66|0.65||||||Due to limited size of sub-sample, we calculated a Cohen's d effect size for raw total score on the PSI from baseline to the 3-month follow-up, with a 95% confidence interval.||.65|-.66|
73855118|NCT03641716|147257055|OTHER||||||<|0.01||||||a prior threshold for statistical significance set at p\<.05|t-test, 2 sided|We ran a paired samples t-test with pre/post intervention data (from baseline and 3-month assessments).||After examining the data to ensure it met the statistical assumptions (e.g. normality, no outliers), we ran a paired-sample pre-post t-test to examine the difference in scores from baseline to 3 months on the NutriSTEP (Screening Tool for Every Preschooler) assessment.||||<.01
73855119|NCT02487654|147257056|SUPERIORITY||||||<|0.05|||||||Log Rank|||||||<0.05
73855120|NCT00349921|147257078|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Null hypothesis is that there is no difference between the groups in proportion of patients meeting the success criterion of \>30% reduction in visual analog scale pain 120 min after intrathecal injection||||>0.05
73855121|NCT02602275|147257115|SUPERIORITY|||||||0.004||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||0.004
73855122|NCT02602275|147257116|SUPERIORITY||||||>|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||>0.05
73855123|NCT02602275|147257117|SUPERIORITY||||||<|0.001||||||Significance level was 0.05.|Paired t-test|The outcome was deemed exploratory, as multiplicity was controlled using a priori ordered hypotheses, but the preceding endpoint was not met.||||||<0.001
73855124|NCT02602275|147257118|SUPERIORITY||||||>|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||>0.05
73904971|NCT03607422|147340222|SUPERIORITY||Adjusted Response Rate Difference|59.9|||<|0.001|TWO_SIDED|95.0|45.9|73.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||73.8|45.9|<0.001
73904972|NCT03607422|147340222|SUPERIORITY||Adjusted Response Rate Difference|55.8|||<|0.001|TWO_SIDED|95.0|41.1|70.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.4|41.1|<0.001
73904973|NCT03607422|147340223|SUPERIORITY||Adjusted Response Rate Difference|53.9|||<|0.001|TWO_SIDED|95.0|40.6|67.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.3|40.6|<0.001
73904974|NCT03607422|147340223|SUPERIORITY||Adjusted Response Rate Difference|39.4|||<|0.001|TWO_SIDED|95.0|25.7|53.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.1|25.7|<0.001
73904975|NCT03607422|147340224|SUPERIORITY||Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|40.0|66.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.1|40.0|<0.001
73904976|NCT03607422|147340224|SUPERIORITY||Adjusted Response Rate Difference|35.0|||<|0.001|TWO_SIDED|95.0|21.8|48.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.2|21.8|<0.001
73904977|NCT03607422|147340225|SUPERIORITY||Adjusted Response Rate Difference|60.2|||<|0.001|TWO_SIDED|95.0|47.5|72.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.9|47.5|<0.001
73904978|NCT03607422|147340225|SUPERIORITY||Adjusted Response Rate Difference|46.7|||<|0.001|TWO_SIDED|95.0|33.4|59.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.9|33.4|<0.001
73904979|NCT03607422|147340226|SUPERIORITY||Adjusted Response Rate Difference|46.4|||<|0.001|TWO_SIDED|95.0|33.2|59.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.6|33.2|<0.001
73904980|NCT03607422|147340226|SUPERIORITY||Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|21.4|48.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.4|21.4|<0.001
73904981|NCT03607422|147340227|SUPERIORITY||Adjusted Response Rate Difference|46.2|||<|0.001|TWO_SIDED|95.0|32.4|60.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.0|32.4|<0.001
73904982|NCT03607422|147340227|SUPERIORITY||Adjusted Response Rate Difference|31.3|||<|0.001|TWO_SIDED|95.0|17.3|45.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||45.3|17.3|<0.001
73904983|NCT03607422|147340228|SUPERIORITY||Adjusted Response Rate Difference|5.0||||0.075|TWO_SIDED|95.0|-0.5|10.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||10.6|-0.5|0.075
73904984|NCT03607422|147340228|SUPERIORITY||Adjusted Response Rate Difference|12.7||||0.005|TWO_SIDED|95.0|3.9|21.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.5|3.9|0.005
73904985|NCT03607422|147340229|SUPERIORITY||Adjusted Response Rate Difference|3.2||||0.151|TWO_SIDED|95.0|-1.2|7.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||7.6|-1.2|0.151
73904986|NCT03607422|147340230|SUPERIORITY||Adjusted Response Rate Difference|12.9||||0.008|TWO_SIDED|95.0|3.4|22.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||22.3|3.4|0.008
73904987|NCT03607422|147340231|SUPERIORITY||Adjusted Response Rate Difference|-18.0|||<|0.001|TWO_SIDED|95.0|-28.0|-8.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-8.0|-28.0|<0.001
73904988|NCT03607422|147340231|SUPERIORITY||Adjusted Response Rate Difference|-17.9||||0.001|TWO_SIDED|95.0|-28.1|-7.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-7.7|-28.1|0.001
73904989|NCT03607422|147340232|SUPERIORITY||Adjusted Response Rate Difference|51.5|||<|0.001|TWO_SIDED|95.0|34.8|68.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.3|34.8|<0.001
73904990|NCT03607422|147340232|SUPERIORITY||Adjusted Response Rate Difference|29.2||||0.001|TWO_SIDED|95.0|11.8|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||46.6|11.8|0.001
73904991|NCT03607422|147340233|SUPERIORITY||Adjusted Response Rate Difference|53.2|||<|0.001|TWO_SIDED|95.0|38.4|68.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.0|38.4|<0.001
73904992|NCT03607422|147340233|SUPERIORITY||Adjusted Response Rate Difference|31.8|||<|0.001|TWO_SIDED|95.0|16.5|47.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||47.1|16.5|<0.001
73904993|NCT03607422|147340234|SUPERIORITY||Adjusted Response Rate Difference|48.9|||<|0.001|TWO_SIDED|95.0|33.8|64.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||64.1|33.8|<0.001
73930898|NCT00261716|147391652|SUPERIORITY_OR_OTHER|||||||0.39|||||||Mixed Models Analysis|employment status X time effect (F(1,54)=.74||||||.39
74025264|NCT01416181|147603785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.0012|TWO_SIDED|95.0|0.4|0.8|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (either hand)||0.80|0.40|0.0012
74025265|NCT01416181|147603785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.1251|TWO_SIDED|95.0|0.48|1.09|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (dominant hand)||1.09|0.48|0.1251
74025266|NCT01416181|147603785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.0091|TWO_SIDED|95.0|0.39|0.87|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (non-dominant hand)||0.87|0.39|0.0091
74025267|NCT01416181|147603787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.4369|TWO_SIDED|95.0|0.8|1.7|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (\<=5.5 or \>=6) and T25FW.|active/placebo|||1.70|0.80|0.4369
74025268|NCT01416181|147603788|SUPERIORITY_OR_OTHER|||||||0.5409|||||||ANCOVA|p-value for comparison between the active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL MSWS-12.||||||0.5409
74025269|NCT01416181|147603789|SUPERIORITY_OR_OTHER|||||||0.2586|||||||ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL ABILHAND.||||||0.2586
74025270|NCT01416181|147603790|SUPERIORITY_OR_OTHER|||||||0.1529|||||||ANCOVA|p-value for comparison between active \& placebo groups at Wk 96 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL MSIS-29 physical score.||||||0.1529
74025271|NCT01416181|147603791|SUPERIORITY_OR_OTHER|||||||0.2424||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL brain volume.||Only participants with BL brain volume are included in the p-value calculation.||||0.2424
74025272|NCT01416181|147603792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.1052|TWO_SIDED|95.0|0.58|1.05|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (\<=5.5 or \>=6).||||1.05|0.58|0.1052
73904994|NCT03607422|147340234|SUPERIORITY||Adjusted Response Rate Difference|37.3|||<|0.001|TWO_SIDED|95.0|21.1|53.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.6|21.1|<0.001
73904995|NCT03607422|147340235|SUPERIORITY||Adjusted Response Rate Difference|53.8|||<|0.001|TWO_SIDED|95.0|37.4|70.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.2|37.4|<0.001
73904996|NCT03607422|147340235|SUPERIORITY||Adjusted Response Rate Difference|42.0|||<|0.001|TWO_SIDED|95.0|24.3|59.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.7|24.3|<0.001
73904997|NCT03607422|147340236|SUPERIORITY||Adjusted Response Rate Difference|45.3|||<|0.001|TWO_SIDED|95.0|28.0|62.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||62.7|28.0|<0.001
73904998|NCT03607422|147340236|SUPERIORITY||Adjusted Response Rate Difference|29.8||||0.002|TWO_SIDED|95.0|10.7|48.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.8|10.7|0.002
73904999|NCT03607422|147340237|SUPERIORITY||Adjusted Response Rate Difference|17.1|||<|0.001|TWO_SIDED|95.0|7.5|26.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||26.7|7.5|<0.001
73905000|NCT03607422|147340237|SUPERIORITY||Adjusted Response Rate Difference|13.7||||0.006|TWO_SIDED|95.0|3.9|23.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||23.5|3.9|0.006
73905001|NCT03607422|147340238|SUPERIORITY||LS Mean Difference|-55.93|STANDARD_ERROR_OF_MEAN|7.284|<|0.001|TWO_SIDED|95.0|-70.32|-41.55|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-41.55|-70.32|<0.001
73905002|NCT03607422|147340238|SUPERIORITY||LS Mean Difference|-36.54|STANDARD_ERROR_OF_MEAN|7.384|<|0.001|TWO_SIDED|95.0|-51.12|-21.96|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-21.96|-51.12|<0.001
73905003|NCT03607422|147340239|SUPERIORITY||LS Mean Difference|-42.62|STANDARD_ERROR_OF_MEAN|6.432|<|0.001|TWO_SIDED|95.0|-55.34|-29.9|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-29.90|-55.34|<0.001
73905004|NCT03607422|147340239|SUPERIORITY||LS Mean Difference|-35.66|STANDARD_ERROR_OF_MEAN|6.447|<|0.001|TWO_SIDED|95.0|-48.41|-22.9|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-22.90|-48.41|<0.001
73905005|NCT03607422|147340240|SUPERIORITY||Adjusted Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|36.9|68.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.1|36.9|<0.001
73905006|NCT03607422|147340240|SUPERIORITY||Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|21.2|54.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||54.9|21.2|<0.001
73905007|NCT03607422|147340241|SUPERIORITY||Adjusted Response Rate Difference|55.9|||<|0.001|TWO_SIDED|95.0|35.5|76.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||76.3|35.5|<0.001
73905008|NCT03607422|147340241|SUPERIORITY||Adjusted Response Rate Difference|49.6|||<|0.001|TWO_SIDED|95.0|26.3|72.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.9|26.3|<0.001
73905009|NCT03607422|147340242|SUPERIORITY||LS Mean Difference|-44.9|STANDARD_ERROR_OF_MEAN|6.492|<|0.001|TWO_SIDED|95.0|-57.74|-32.06|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-32.06|-57.74|<0.001
73905010|NCT03607422|147340242|SUPERIORITY||LS Mean Difference|-29.98|STANDARD_ERROR_OF_MEAN|6.383|<|0.001|TWO_SIDED|95.0|-42.6|-17.36|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-17.36|-42.60|<0.001
73905011|NCT03607422|147340243|SUPERIORITY||Adjusted Response Rate Difference|27.8||||0.016|TWO_SIDED|95.0|5.2|50.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||50.4|5.2|0.016
73905012|NCT03607422|147340243|SUPERIORITY||Adjusted Response Rate Difference|22.3||||0.062|TWO_SIDED|95.0|-1.1|45.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||45.7|-1.1|0.062
73905013|NCT03607422|147340244|SUPERIORITY||Adjusted Response Rate Difference|38.9|||<|0.001|TWO_SIDED|95.0|18.4|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.4|18.4|<0.001
73905014|NCT03607422|147340244|SUPERIORITY||Adjusted Response Rate Difference|5.9||||0.51|TWO_SIDED|95.0|-11.7|23.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||23.6|-11.7|0.510
73905015|NCT01557894|147340245|SUPERIORITY_OR_OTHER||||||<|0.01|ONE_SIDED|95.0||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor||||||<0.01
73905016|NCT01557894|147340246|SUPERIORITY_OR_OTHER||||||<|0.01|ONE_SIDED|95.0||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor||||||<0.01
73905017|NCT01557894|147340247|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor.||||||<0.01
73905018|NCT01557894|147340248|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
73905019|NCT01557894|147340249|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
73905020|NCT01885871|147340250|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73962847|NCT03903822|147461905|SUPERIORITY||Risk Difference (RD)|33.6||||0.0007|TWO_SIDED|90.0|13.7|49.9|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||49.9|13.7|0.0007
73962848|NCT03903822|147461905|SUPERIORITY||Risk Difference (RD)|19.4||||0.0289|TWO_SIDED|90.0|1.8|36.5|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||36.5|1.8|0.0289
73962849|NCT03903822|147461905|SUPERIORITY||Risk Difference (RD)|13.1||||0.1145|TWO_SIDED|90.0|-2.9|29.6|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||29.6|-2.9|0.1145
73962850|NCT03903822|147461906|SUPERIORITY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|0.79||0.0488|TWO_SIDED|90.0|-2.61|-0.01|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.01|-2.61|0.0488
74025273|NCT01416181|147603793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.0205|TWO_SIDED|95.0|0.47|0.94|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 156 weeks||0.94|0.47|0.0205
73905021|NCT02128828|147340255|SUPERIORITY|||||||0.0079|||||||Wilcoxon (Mann-Whitney)|||||||0.0079
73905022|NCT00090051|147340256|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0218|TWO_SIDED|95.0|0.6|0.96|||Log Rank|non-stratified|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the fludarabine+cyclophosphamide(FC) group.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the fludarabine+cyclophosphamide+rituximab (FCR) group.||0.96|0.60|0.0218
73905023|NCT00090051|147340257|SUPERIORITY_OR_OTHER|||||||0.2874||95.0|||||Log Rank|non-stratified||||||0.2874
73905024|NCT00090051|147340259|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Log Rank|non-stratified||||||0.0002
73905025|NCT00090051|147340262|SUPERIORITY_OR_OTHER|||||||0.8842||95.0|||||Log Rank|non-stratified||||||0.8842
73905026|NCT00090051|147340264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.8|||Log Rank|||||0.80|0.54|<.0001
73905027|NCT00090051|147340265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5976|TWO_SIDED|95.0|0.74|1.19|||Log Rank|||||1.19|0.74|0.5976
73905028|NCT00090051|147340266|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.54|0.79|||Log Rank|||||0.79|0.54|<.0001
73905029|NCT00090051|147340267|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.0005|TWO_SIDED|95.0|1.39|3.35|||Chi-squared|||||3.35|1.39|0.0005
73905030|NCT00090051|147340268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.3085|TWO_SIDED|95.0|0.46|1.28|||Log Rank|||||1.28|0.46|0.3085
73905031|NCT00090051|147340269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0007|TWO_SIDED|95.0|0.51|0.84|||Log Rank|||||0.84|0.51|0.0007
73905032|NCT00090051|147340270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0002|TWO_SIDED|95.0|0.55|0.84|||Log Rank|||||0.84|0.55|0.0002
73905033|NCT03228420|147340271|SUPERIORITY||||||<|0.001||||||2-sided alpha level of 0.05|Fisher Exact|||||||<0.001
73905034|NCT00085709|147340292|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Cox|The interim analysis only reported a p-value for testing whether the hazard ratio was not equal to 1.5.||Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.||||<0.001
73962851|NCT03903822|147461906|SUPERIORITY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.788||0.0413|TWO_SIDED|90.0|-2.66|-0.07|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.07|-2.66|0.0413
74025274|NCT01416181|147603793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.1305|TWO_SIDED|95.0|0.48|1.1|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS at 156 weeks||1.10|0.48|0.1305
74025275|NCT01416181|147603793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.1988|TWO_SIDED|95.0|0.57|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW at 156 weeks||1.12|0.57|0.1988
74025276|NCT01416181|147603793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0093|TWO_SIDED|95.0|0.39|0.88|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (either hand) at 156 weeks||0.88|0.39|0.0093
74025277|NCT01416181|147603793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.054|TWO_SIDED|95.0|0.39|1.01|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors onm 9HPT (dominant hand) at 156 weeks||1.01|0.39|0.0540
74025278|NCT01416181|147603793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.141|TWO_SIDED|95.0|0.44|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (non-dominant hand) at 156 weeks||1.12|0.44|0.1410
73855125|NCT02602275|147257119|SUPERIORITY||||||<|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the AAL (Automated Anatomical Labelling Atlas) coordinates.|Paired t-test|The outcome was deemed exploratory, as multiplicity was controlled using a priori ordered hypotheses, but a preceding endpoint was not met.||||||<0.05
74025279|NCT01416181|147603794|SUPERIORITY_OR_OTHER|||||||0.0273|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||Week 156||||0.0273
74025280|NCT01416181|147603794|SUPERIORITY_OR_OTHER|||||||0.1974|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||CP Group: Week 156||||0.1974
74025281|NCT01416181|147603794|SUPERIORITY_OR_OTHER|||||||0.2506|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||NP Group: Week 156||||0.2506
74025282|NCT01416181|147603795|SUPERIORITY_OR_OTHER|||||||0.096|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||Overall: Week 156||||0.0960
73855126|NCT02333396|147257120|SUPERIORITY||Beta Estimate|3.57|STANDARD_ERROR_OF_MEAN|4.53||0.44|TWO_SIDED|95.0|-5.77|12.9|||Mixed Models Analysis|||||12.9|-5.77|0.44
73855127|NCT02333396|147257121|SUPERIORITY||Beta Estimate|3.62|STANDARD_ERROR_OF_MEAN|2.05||0.09|TWO_SIDED|95.0|-0.61|7.84|||Mixed Models Analysis|||||7.84|-0.61|0.09
73855128|NCT02333396|147257122|SUPERIORITY||Beta Estimate|4.13|STANDARD_ERROR_OF_MEAN|2.05||0.05|TWO_SIDED|95.0|-0.09|8.36|||Mixed Models Analysis|||||8.36|-0.09|0.05
73855129|NCT02333396|147257123|SUPERIORITY||Beta Estimare|3.02|STANDARD_ERROR_OF_MEAN|2.26||0.19|TWO_SIDED|95.0|-1.63|7.67|||Mixed Models Analysis|||||7.67|-1.63|0.19
74025283|NCT01416181|147603795|SUPERIORITY_OR_OTHER|||||||0.4957|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||CP Group: Week 156||||0.4957
74025284|NCT01416181|147603795|SUPERIORITY_OR_OTHER|||||||0.2916|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||NP Group: Week 156||||0.2916
74025285|NCT01416181|147603796|SUPERIORITY_OR_OTHER|||||||0.1119|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||Overall, Week 156||||0.1119
73855130|NCT02333396|147257124|SUPERIORITY||Beta Estimate|-0.22|STANDARD_ERROR_OF_MEAN|2.47||0.93|TWO_SIDED|95.0|-5.33|4.88|||Mixed Models Analysis|||||4.88|-5.33|0.93
73855131|NCT02333396|147257125|SUPERIORITY||Beta Estimate|-0.35|STANDARD_ERROR_OF_MEAN|1.29||0.79|TWO_SIDED|95.0|-3.02|2.31|||Mixed Models Analysis|||||2.31|-3.02|0.79
73855132|NCT02333396|147257128|SUPERIORITY||Beta Estimate|0.49|STANDARD_ERROR_OF_MEAN|1.03||0.64|TWO_SIDED|95.0|-2.62|1.64|||Mixed Models Analysis|||||1.64|-2.62|0.64
73855133|NCT02333396|147257129|SUPERIORITY||Beta Estimate|-0.9|STANDARD_ERROR_OF_MEAN|1.03||0.39|TWO_SIDED|95.0|-3.02|1.22|||Mixed Models Analysis|||||1.22|-3.02|0.39
73855134|NCT02333396|147257131|SUPERIORITY||Beta Estiamte|1.72|STANDARD_ERROR_OF_MEAN|1.1||0.13|TWO_SIDED|95.0|-0.55|3.98|||Mixed Models Analysis|||||3.98|-0.55|0.13
73855135|NCT02333396|147257132|SUPERIORITY||Beta Estimate|1.72|STANDARD_ERROR_OF_MEAN|1.1||0.13|TWO_SIDED|95.0|-0.55|3.98|||Mixed Models Analysis|||||3.98|-0.55|0.13
73855136|NCT03802630|147257134|NON_INFERIORITY|Non-inferiority was considered established if the lower limit of the corresponding 95% CI for the estimated between group difference (brolucizumab vs. aflibercept) on change from baseline in BCVA at Week 24 is greater than -4 letters.|Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.01||0.018|TWO_SIDED|95.0|-3.9|0.1|||ANOVA|||||0.1|-3.9|0.018
74025286|NCT01416181|147603796|SUPERIORITY_OR_OTHER|||||||0.1129|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||CP Group: Week 156||||0.1129
73855137|NCT01108731|147257150|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||General Linear Model (GLM)|||||||<0.05
73855138|NCT01108731|147257151|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||General Linear Model (GLM)|||||||<0.05
73855139|NCT01108731|147257152|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73905035|NCT00085709|147340293|SUPERIORITY_OR_OTHER||||||<|0.0025||95.0|||||Test of difference of proportions|||Interim futility analysis alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.||||<0.0025
74025287|NCT01416181|147603796|SUPERIORITY_OR_OTHER|||||||0.2351|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||NP Group: Week 156||||0.2351
74025288|NCT01416181|147603797|SUPERIORITY_OR_OTHER|||||||0.0261|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||Overall: Week 156||||0.0261
74025289|NCT01416181|147603797|SUPERIORITY_OR_OTHER|||||||0.0585|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||CP Group: Week 156||||0.0585
74025290|NCT01416181|147603797|SUPERIORITY_OR_OTHER|||||||0.6095|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||NP Group: Week 156||||0.6095
74025291|NCT01416181|147603798|SUPERIORITY_OR_OTHER|||||||0.723|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||Overall: Week 156||||0.7230
74025292|NCT01416181|147603798|SUPERIORITY_OR_OTHER|||||||0.8781|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||CP Group: Week 156||||0.8781
73855141|NCT02488135|147257164|NON_INFERIORITY|An a priori sample size was calculated using a non-inferiority limit (d) set at 25%, significance level (α) of 5% and power of 80%. We assumed that success in each group would be 93% based on the literature examining anterior nasal packing in ideal conditions and considering our selection criteria in the Floseal® (Baxter, USA) population. Attrition was assumed to be 0% due to the short duration of treatment. This yielded 26 participants with 13 patients in each study arm.||||||1|||||||Fisher Exact|||||||1.000
73855142|NCT02488135|147257165|SUPERIORITY|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups for pain during placement.||||0.0022
73855143|NCT02488135|147257165|SUPERIORITY|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups for pain during treatment.||||0.0007
73855144|NCT02488135|147257165|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||Comparison between scores for pain during removal.||||0.0021
73855145|NCT01252186|147257166|NON_INFERIORITY_OR_EQUIVALENCE|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|-11.54||||0.958|TWO_SIDED|95.0|-440.1|417.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||417.0|-440.1|0.958
73855146|NCT01252186|147257166|NON_INFERIORITY_OR_EQUIVALENCE|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|422.76||||0.06|TWO_SIDED|95.0|-18.3|863.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||863.8|-18.3|0.060
73855147|NCT01252186|147257167|SUPERIORITY_OR_OTHER||Treatment Difference|-14.31||||0.745|TWO_SIDED|95.0|-100.8|72.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||72.2|-100.8|0.745
73855148|NCT01252186|147257167|SUPERIORITY_OR_OTHER||Treatment Difference|71.31||||0.115|TWO_SIDED|95.0|-17.5|160.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||160.1|-17.5|0.115
73855149|NCT01252186|147257168|SUPERIORITY_OR_OTHER||Treatment Difference|-17.14||||0.782|TWO_SIDED|95.0|-139.4|105.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||105.1|-139.4|0.782
73855150|NCT01252186|147257168|SUPERIORITY_OR_OTHER||Treatment Difference|97.09||||0.131|TWO_SIDED|95.0|-29.2|223.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||223.4|-29.2|0.131
73930899|NCT03969212|147391685|SUPERIORITY||Adjusted OR (BMX vs Placebo)|0.68|||=|0.013|TWO_SIDED|95.38|0.5|0.93|||GEE|||The odds ratio (OR) shown represents the odds of Baloxavir Marboxil (BMX) versus the odds of Placebo.||0.93|0.50|= 0.013
73930900|NCT03969212|147391686|SUPERIORITY||Adjusted OR (BMX vs Placebo)|0.75|||=|0.155|TWO_SIDED|95.38|0.5|1.12|||GEE model|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.12|0.50|= 0.1550
73930901|NCT03969212|147391687|OTHER||Odds Ratio (BMX vs Placebo}]|0.76|||||TWO_SIDED|95.38|0.55|1.06||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.06|0.55|
73930902|NCT03969212|147391688|OTHER||Odds Ratio (BMX vs Placebo)|0.69|||||TWO_SIDED|95.38|0.46|1.04||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.04|0.46|
73930903|NCT03969212|147391689|OTHER||Adjusted OR (BMX vs Placebo)|0.66|||||TWO_SIDED|95.38|0.48|0.91|||GEE model|||The OR shown represents the odds of BMX versus the odds of Placebo.||0.91|0.48|
73930904|NCT03969212|147391690|OTHER||Adjusted OR (BMX vs Placebo)|0.73|||||TWO_SIDED|95.38|0.48|1.09|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.09|0.48|
73930905|NCT03969212|147391691|OTHER||Adjusted OR (BMX vs Placebo)|0.71|||||TWO_SIDED|95.38|0.53|0.94|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||0.94|0.53|
73930906|NCT03969212|147391692|OTHER||Odds Ratio (BMX vs Placebo)|0.79|||||TWO_SIDED|95.38|0.59|1.06||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.06|0.59|
73905036|NCT01896479|147340334|NON_INFERIORITY|The non-inferiority margin used was 1.58.|Cox Proportional Hazard|1.24||||0.1916|TWO_SIDED|95.0|0.9|1.7||Stratification factors comprised RET M918T mutational status (positive, negative, and unknown).|Log Rank|||||1.70|0.90|0.1916
74025293|NCT01416181|147603798|SUPERIORITY_OR_OTHER|||||||0.2751|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||NP Group: Week 156||||0.2751
74025294|NCT01416181|147603799|SUPERIORITY_OR_OTHER|||||||0.5051|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||Overall: Week 156||||0.5051
74025295|NCT01416181|147603799|SUPERIORITY_OR_OTHER|||||||0.7283|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||CP Group: Week 156||||0.7283
74025296|NCT01416181|147603799|SUPERIORITY_OR_OTHER|||||||0.1666|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||NP Group: Week 156||||0.1666
74025297|NCT01416181|147603800|SUPERIORITY_OR_OTHER|||||||0.433|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156||||0.4330
74025298|NCT01416181|147603800|SUPERIORITY_OR_OTHER|||||||0.7122|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156||||0.7122
74025299|NCT01416181|147603800|SUPERIORITY_OR_OTHER|||||||0.3861|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156||||0.3861
73905037|NCT01896479|147340335|OTHER|Descriptive statistical analysis.|Odds Ratio (OR)|1.0195||||0.9437|TWO_SIDED|95.0|0.6|1.7|||Cochran-Mantel-Haenszel|Stratification factors comprised RET M918T mutational status (positive, negative, and unknown).||||1.7|0.6|0.9437
73905038|NCT03139604|147340336|OTHER||Odds Ratio (OR)|1.45||||0.0782|TWO_SIDED|95.0|0.959|2.204||Not adjusted for multiplicity with interim and final analyses|Cochran-Mantel-Haenszel|||binomial distribution||2.204|0.959|0.0782
73905039|NCT02007512|147340371|OTHER||Hazard Ratio (HR)|0.82||||0.3631|TWO_SIDED|95.0|0.535|1.257|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.257|0.535|0.3631
74025300|NCT01416181|147603801|SUPERIORITY_OR_OTHER|||||||0.7225|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156||||0.7225
74025301|NCT01416181|147603801|SUPERIORITY_OR_OTHER|||||||0.9121|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156||||0.9121
74025302|NCT01416181|147603801|SUPERIORITY_OR_OTHER|||||||0.2594|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156||||0.2594
73905040|NCT02007512|147340371|OTHER||Hazard Ratio (HR)|1.022||||0.9212|TWO_SIDED|95.0|0.659|1.586|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.586|0.659|0.9212
73905041|NCT02007512|147340372|OTHER||Hazard Ratio (HR)|0.442||||0.0335|TWO_SIDED|95.0|0.205|0.955|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||0.955|0.205|0.0335
73905042|NCT02007512|147340372|OTHER||Hazard Ratio (HR)|0.554||||0.1936|TWO_SIDED|95.0|0.225|1.363|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.363|0.225|0.1936
73905043|NCT02007512|147340389|OTHER||Hazard Ratio (HR)|0.928||||0.7378|TWO_SIDED|95.0|0.599|1.438|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.438|0.599|0.7378
73905044|NCT02007512|147340389|OTHER||Hazard Ratio (HR)|0.968||||0.8817|TWO_SIDED|95.0|0.632|1.483|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.483|0.632|0.8817
73905045|NCT02007512|147340390|OTHER||Hazard Ratio (HR)|0.522||||0.127|TWO_SIDED|95.0|0.224|1.217|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.217|0.224|0.1270
73905046|NCT02007512|147340390|OTHER||Hazard Ratio (HR)|0.37||||0.0359|TWO_SIDED|95.0|0.143|0.961|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||0.961|0.143|0.0359
73930907|NCT03969212|147391693|OTHER||Adjusted OR (BMX vs Placebo)|0.72|||||TWO_SIDED|95.38|0.49|1.07|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.07|0.49|
73930908|NCT03969212|147391694|OTHER||Odds Ratio (BMX vs Placebo)|0.71|||||TWO_SIDED|95.38|0.48|1.04||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.04|0.48|
73930909|NCT00280566|147391704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|||||||Log Rank|alpha = 0.05 level of significance||Equality of Survival Curves across the treatment groups.||||0.0104
73930910|NCT00280566|147391705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047|||||||Log Rank|No adjustment made for multiple comparisons||alpha = 0.05 level of significance||||0.0047
73930911|NCT00280566|147391706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0205||||||No adjustment made for multiple comparisons|Log Rank|||alpha = 0.05 level of significance||||0.0205
73930912|NCT00280566|147391707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.55||0.1247|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1: Difference in Change during Period 2 MMRM ANCOVA: center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1247
73930913|NCT00280566|147391707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7515|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7515
73930914|NCT00280566|147391707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.62||0.3074|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3074
73905047|NCT01052844|147340457|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||Complete protection from nausea and vomiting (CP) was defined as the absence of any episode of nausea or vomiting and no use of rescue medication. CP was further defined as either acute (ACP), when occurring during the first 24 hours after chemotherapy; delayed (DCP), when occurring during the period from days 2 through 5 after chemotherapy; or overall, when occurring over the entire period of the study (first 120 hours).||||0.04
73905048|NCT01052844|147340458|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||We evaluated associations between categorical variables using the Chi-Square test||||0.06
73962852|NCT03903822|147461906|SUPERIORITY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.773||0.02|TWO_SIDED|90.0|-2.86|-0.32|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.32|-2.86|0.0200
73962853|NCT03903822|147461906|SUPERIORITY||LS Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.758||0.0011|TWO_SIDED|90.0|-3.58|-1.08|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-1.08|-3.58|0.0011
73962854|NCT03903822|147461906|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.535||0.0727|TWO_SIDED|90.0|-1.66|0.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||0.10|-1.66|0.0727
73962855|NCT03903822|147461906|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.534||0.001|TWO_SIDED|90.0|-2.52|-0.77|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.77|-2.52|0.0010
73962856|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|0.5||||0.5246|TWO_SIDED|90.0|-14.7|16.4|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||16.4|-14.7|0.5246
73962857|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|3.8||||0.3906|TWO_SIDED|90.0|-12.5|19.9|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||19.9|-12.5|0.3906
73962858|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|13.5||||0.1193|TWO_SIDED|90.0|-3.2|30.6|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||30.6|-3.2|0.1193
73962859|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|28.2||||0.0048|TWO_SIDED|90.0|8.8|45.5|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||45.5|8.8|0.0048
73962860|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|14.7||||0.0777|TWO_SIDED|90.0|-2.0|31.1|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||31.1|-2.0|0.0777
73962861|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|11.8||||0.1245|TWO_SIDED|90.0|-4.3|28.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||28.0|-4.3|0.1245
73962862|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|6.2||||0.3322|TWO_SIDED|90.0|-12.2|24.4|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||24.4|-12.2|0.3322
73962863|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|18.5||||0.0535|TWO_SIDED|90.0|-0.3|36.5|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||36.5|-0.3|0.0535
73962864|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|24.3||||0.0159|TWO_SIDED|90.0|4.5|41.9|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||41.9|4.5|0.0159
73962865|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|36.8||||0.0008|TWO_SIDED|90.0|15.4|54.0|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||54.0|15.4|0.0008
73905049|NCT00559754|147340485|SUPERIORITY_OR_OTHER|||||||0.4915|||||||Fisher Exact|||||||0.4915
73905050|NCT00559754|147340486|SUPERIORITY_OR_OTHER|||||||0.4864|||||||Chi-squared|||||||0.4864
73905051|NCT00559754|147340487|SUPERIORITY_OR_OTHER|||||||0.3613|||||||Fisher Exact|||||||0.3613
73905052|NCT00559754|147340488|SUPERIORITY_OR_OTHER|||||||0.6605|||||||Fisher Exact|||||||0.6605
73962866|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|20.7||||0.0386|TWO_SIDED|90.0|1.5|38.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||38.8|1.5|0.0386
73962867|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|12.1||||0.1485|TWO_SIDED|90.0|-6.4|30.3|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||30.3|-6.4|0.1485
73962868|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|17.3||||0.062|TWO_SIDED|90.0|-0.8|34.8|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||34.8|-0.8|0.0620
73962869|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|26.9||||0.0089|TWO_SIDED|90.0|6.5|44.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||44.4|6.5|0.0089
73962870|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|37.8||||0.0005|TWO_SIDED|90.0|17.5|54.7|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||54.7|17.5|0.0005
73962871|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|36.7||||0.0007|TWO_SIDED|90.0|15.4|54.0|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||54.0|15.4|0.0007
73962872|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|18.1||||0.0711|TWO_SIDED|90.0|-2.0|37.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||37.5|-2.0|0.0711
73962873|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|23.8||||0.0266|TWO_SIDED|90.0|2.7|42.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||42.5|2.7|0.0266
73962874|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|3.8||||0.4173|TWO_SIDED|90.0|-15.3|23.1|||Chan and Zhang Exact Method|||At week 4: Risk difference = difference in percentage of participants.||23.1|-15.3|0.4173
73962875|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|16.3||||0.1096|TWO_SIDED|90.0|-4.3|35.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||35.6|-4.3|0.1096
73962876|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|27.0||||0.0133|TWO_SIDED|90.0|6.1|45.7|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||45.7|6.1|0.0133
73855151|NCT01252186|147257169|SUPERIORITY_OR_OTHER||Treatment Difference|-0.04||||0.428|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.1|-0.1|0.428
74025303|NCT01416181|147603802|SUPERIORITY_OR_OTHER|||||||0.8066|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 6MWT.||Week 156||||0.8066
74025304|NCT01416181|147603804|SUPERIORITY_OR_OTHER|||||||0.7084|||||||ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL MSIS-29 physical score.||||||0.7084
73855152|NCT01252186|147257169|SUPERIORITY_OR_OTHER||Treatment Difference|-0.16||||0.002|TWO_SIDED|95.0|-0.3|-0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-0.1|-0.3|0.002
73855153|NCT01252186|147257170|SUPERIORITY_OR_OTHER||Treatment Difference|-0.01||||0.868|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.1|-0.2|0.868
73855154|NCT01252186|147257170|SUPERIORITY_OR_OTHER||Treatment Difference|0.2||||0.012|TWO_SIDED|95.0|0.0|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|0.0|0.012
73855155|NCT01252186|147257171|SUPERIORITY_OR_OTHER||Treatment Difference|0.09||||0.317|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|-0.1|0.317
73855156|NCT01252186|147257171|SUPERIORITY_OR_OTHER||Treatment Difference|-0.16||||0.081|TWO_SIDED|95.0|-0.4|0.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.0|-0.4|0.081
73855157|NCT01252186|147257172|SUPERIORITY_OR_OTHER||Treatment Difference|-0.004||||0.331|TWO_SIDED|95.0|-0.013|0.004|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.004|-0.013|0.331
73855158|NCT01252186|147257172|SUPERIORITY_OR_OTHER||Treatment Difference|-0.006||||0.173|TWO_SIDED|95.0|-0.015|0.003|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.003|-0.015|0.173
73855159|NCT01252186|147257173|SUPERIORITY_OR_OTHER||Treatment Difference|-0.57||||0.194|TWO_SIDED|95.0|-1.4|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|-1.4|0.194
73855160|NCT01252186|147257173|SUPERIORITY_OR_OTHER||Treatment Difference|-0.02||||0.967|TWO_SIDED|95.0|-0.9|0.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.9|-0.9|0.967
73855161|NCT01252186|147257174|SUPERIORITY_OR_OTHER||Treatment Difference|1.09||||0.648|TWO_SIDED|95.0|-3.6|5.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||5.8|-3.6|0.648
73855162|NCT01252186|147257174|SUPERIORITY_OR_OTHER||Treatment Difference|1.68||||0.496|TWO_SIDED|95.0|-3.2|6.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||6.6|-3.2|0.496
73855163|NCT01252186|147257175|SUPERIORITY_OR_OTHER||Treatment Difference|8.71||||0.405|TWO_SIDED|95.0|-11.9|29.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||29.3|-11.9|0.405
73855164|NCT01252186|147257175|SUPERIORITY_OR_OTHER||Treatment Difference|28.95||||0.008|TWO_SIDED|95.0|7.7|50.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||50.2|7.7|0.008
73905053|NCT00559754|147340489|SUPERIORITY_OR_OTHER|||||||0.8311|||||||Fisher Exact|||||||0.8311
74025305|NCT01416181|147603806|SUPERIORITY_OR_OTHER|||||||0.3465|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL SDMT.||Week 156||||0.3465
73855165|NCT01252186|147257176|SUPERIORITY_OR_OTHER||Treatment Difference|3.3||||0.425|TWO_SIDED|195.0|-4.9|11.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||11.5|-4.9|0.425
73855166|NCT01252186|147257176|SUPERIORITY_OR_OTHER||Treatment Difference|8.76||||0.041|TWO_SIDED|95.0|0.3|17.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||17.2|0.3|0.041
73855167|NCT01252186|147257177|SUPERIORITY_OR_OTHER||Treatment Difference|-2.4||||0.088|TWO_SIDED|95.0|-5.2|0.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.4|-5.2|0.088
73855168|NCT01252186|147257177|SUPERIORITY_OR_OTHER||Treatment Difference|-3.19||||0.028|TWO_SIDED|95.0|-6.0|-0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-0.3|-6.0|0.028
73855169|NCT01252186|147257178|SUPERIORITY_OR_OTHER||Treatment Difference|1.75||||0.631|TWO_SIDED|95.0|-5.4|8.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||8.9|-5.4|0.631
73855170|NCT01252186|147257178|SUPERIORITY_OR_OTHER||Treatment Difference|3.73||||0.323|TWO_SIDED|95.0|-3.7|11.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||11.2|-3.7|0.323
73855171|NCT01252186|147257179|SUPERIORITY_OR_OTHER||Treatment Difference|-0.86||||0.783|TWO_SIDED|595.0|-7.0|5.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||5.3|-7.0|0.783
73855172|NCT01252186|147257179|SUPERIORITY_OR_OTHER||Treatment Difference|-2.83||||0.384|TWO_SIDED|95.0|-9.2|3.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||3.6|-9.2|0.384
73905054|NCT00559754|147340490|SUPERIORITY_OR_OTHER|||||||0.223|||||||Fisher Exact|||||||0.2230
73905055|NCT00559754|147340491|SUPERIORITY_OR_OTHER|||||||0.8696|||||||Fisher Exact|||||||0.8696
73905056|NCT00559754|147340492|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Fisher Exact|||||||0.0074
73905057|NCT00559754|147340493|SUPERIORITY_OR_OTHER|||||||0.3235|||||||Fisher Exact|||||||0.3235
73905058|NCT00559754|147340494|SUPERIORITY_OR_OTHER|||||||0.0693|||||||Fisher Exact|||||||0.0693
73855173|NCT01252186|147257180|SUPERIORITY_OR_OTHER||Treatment Difference|1.66||||0.572|TWO_SIDED|95.0|-4.1|7.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||7.5|-4.1|0.572
73855174|NCT01252186|147257180|SUPERIORITY_OR_OTHER||Treatment Difference|-20.98|||<|0.001|TWO_SIDED|95.0|-27.0|-15.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-15.0|-27.0|<0.001
73855175|NCT01252186|147257181|SUPERIORITY_OR_OTHER||Treatment Difference|-0.42||||0.841|TWO_SIDED|95.0|-4.6|3.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||3.7|-4.6|0.841
73905059|NCT00559754|147340496|SUPERIORITY_OR_OTHER|||||||0.4254|||||||Fisher Exact|||||||0.4254
73905060|NCT00559754|147340498|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73905061|NCT00559754|147340499|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73905062|NCT00559754|147340501|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73905063|NCT00701376|147340508|SUPERIORITY||Mean Difference (Net)|-6.32||||0.03|TWO_SIDED|99.8|-15.6|2.94|||paired t-test|||||2.94|-15.6|0.03
73905064|NCT00701376|147340509|SUPERIORITY||Mean Difference (Net)|-7.56||||0.08|TWO_SIDED|99.8|-22.0|6.83|||Wilcoxon (Mann-Whitney)|||||6.83|-22.0|0.08
73905065|NCT00701376|147340510|SUPERIORITY||Mean Difference (Net)|5.84||||0.14|TWO_SIDED|99.8|-7.55|19.2|||paired t-test|||||19.2|-7.55|0.14
73905066|NCT00701376|147340512|SUPERIORITY||Mean Difference (Net)|-0.2|||<|0.001|TWO_SIDED|99.8|-0.38|-0.02|||paired t-test|||||-0.02|-0.38|<0.001
73905067|NCT00701376|147340513|SUPERIORITY||Mean Difference (Net)|-0.23||||0.1|TWO_SIDED|99.8|-0.68|0.23|||paired t-test|||||0.23|-0.68|0.10
73905068|NCT00701376|147340514|SUPERIORITY||Mean Difference (Net)|-1.72||||0.21|TWO_SIDED|99.8|-8.68|5.25|||paired t-test|||||5.25|-8.68|0.21
73905069|NCT00701376|147340516|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test|||||||0.002
73905070|NCT00701376|147340517|SUPERIORITY|||||||0.04|||||||Wilcoxon signed-rank test|||||||0.04
73905071|NCT00701376|147340518|SUPERIORITY|||||||0.005|||||||Wilcoxon signed-rank test|||||||0.005
73905072|NCT00701376|147340519|SUPERIORITY|||||||0.001|||||||Wilcoxon signed-rank test|||||||0.001
73905073|NCT02537574|147340529|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.264||0.94|TWO_SIDED|95.0|0.61|1.7|||Regression, Logistic|||||1.70|0.61|0.940
73905074|NCT02537574|147340529|SUPERIORITY||Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.207||0.383|TWO_SIDED|95.0|0.48|1.33|||Regression, Logistic|||||1.33|0.48|0.383
73905075|NCT03595774|147340547|SUPERIORITY|||||||0.0833||||||a priori threshold for statistical significance of P\<0.05|ANOVA|One-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.0833
73905076|NCT03595774|147340548|SUPERIORITY|||||||0.0131||||||a priori threshold for statistical significance of P\<0.05|ANOVA|One-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.0131
73905077|NCT03595774|147340549|SUPERIORITY|||||||0.012728||||||a prior threshold for significant of P\<0.05|ANOVA|Two-way ANOVA for repeated measured followed by Holm-Šídák's multiple comparisons test||||||0.012728
73905078|NCT03595774|147340550|SUPERIORITY|||||||2e-08||||||a priori threshold for statistical significance of P\<0.05|ANOVA|Two-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.00000002
73905079|NCT03595774|147340551|SUPERIORITY|||||||0.017215||||||a priori threshold for statistical significance of P\<0.05|ANOVA|Two-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.017215
73905080|NCT01272284|147340554|SUPERIORITY_OR_OTHER_LEGACY||Proportion successful|85.4|||<|0.0001|ONE_SIDED|95.81|78.1||||Fisher Exact|||The final significance level is 0.04191 accounting for one interim analysis conducted at 80% of final information, thus a 95.81% Confidence Limit (CL) was used.|||78.1|<0.0001
73905081|NCT00048061|147340565|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 50/50 mg monthly) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|0.615||||0.045|TWO_SIDED|95.0|0.013|1.216|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 50/50) and the active-control.|||1.216|0.013|0.045
73905082|NCT00048061|147340565|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 100 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|0.297||||0.338|TWO_SIDED|95.0|-0.312|0.906|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 100 mg) and the active-control|||0.906|-0.312|0.338
73905083|NCT00048061|147340565|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 150 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.0||||0.001|TWO_SIDED|95.0|0.395|1.605|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 150 mg) and the active-control.|||1.605|0.395|0.001
73962877|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|23.2||||0.0304|TWO_SIDED|90.0|2.6|41.7|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||41.7|2.6|0.0304
74025306|NCT01416181|147603810|SUPERIORITY_OR_OTHER|||||||0.007||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL normalized brain volume.||Percentage change from Week 24 to Week 156||||0.0070
73905084|NCT00573248|147340658|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
73905085|NCT00573248|147340659|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED||||||ANOVA|||2 (nicotine versus placebo) x 2 (smoker versus nonsmoker) ANOVA||||<0.025
73905086|NCT00573248|147340660|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
73905087|NCT00573248|147340661|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
73905088|NCT02017171|147340662|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.999|TWO_SIDED|95.0|-1.9|1.9||p value is not adjusted for multiple comparisons, a priori threshold for statistical significance: p\<0.05|linear model for correlated errors||Treatment difference = Allopurinol-Placebo|||1.9|-1.9|0.999
73905089|NCT02017171|147340663|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.6|2.2||For secondary outcomes, 95% confidence intervals are reported, without P values. The confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||Treatment difference = Allopurinol - Placebo|||2.2|-1.6|
73905090|NCT02017171|147340664|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.7|2.3||For secondary outcomes, 95% confidence intervals are reported, without P values. The confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||Treatment difference = Allopurinol - Placebo|||2.3|-1.7|
73905091|NCT02017171|147340665|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.5|0.4||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Treatment difference = Allopurinol - Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||0.4|-1.5|
74025307|NCT01416181|147603811|SUPERIORITY_OR_OTHER|||||||0.5034||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL WGM brain volume||Percentage hange from Baseline to Week 156||||0.5034
73962878|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
73962879|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
73905092|NCT02017171|147340666|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.0|0.5||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Treatment difference = Allopurinol - Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||0.5|-1.0|
73855176|NCT01252186|147257181|SUPERIORITY_OR_OTHER||Treatment Difference|-10.53|||<|0.001|TWO_SIDED|95.0|-14.8|-6.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-6.3|-14.8|<0.001
73855177|NCT01252186|147257182|SUPERIORITY_OR_OTHER||Treatment Difference|-2.11||||0.227|TWO_SIDED|95.0|-5.6|1.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||1.3|-5.6|0.227
73855178|NCT01252186|147257182|SUPERIORITY_OR_OTHER||Treatment Difference|-5.99||||0.001|TWO_SIDED|95.0|-9.6|-2.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-2.4|-9.6|0.001
73855179|NCT01252186|147257183|SUPERIORITY_OR_OTHER||Treatment Difference|0.33||||0.076|TWO_SIDED|95.0|0.0|0.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.7|-0.0|0.076
73855180|NCT01252186|147257183|SUPERIORITY_OR_OTHER||Treatment Difference|0.44||||0.021|TWO_SIDED|95.0|0.1|0.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.8|0.1|0.021
73855181|NCT01252186|147257184|SUPERIORITY_OR_OTHER||Treatment Difference|44.46||||0.19|TWO_SIDED|95.0|-22.3|111.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||111.2|-22.3|0.190
73855182|NCT01252186|147257184|SUPERIORITY_OR_OTHER||Treatment Difference|9.74||||0.781|TWO_SIDED|95.0|-59.4|78.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||78.9|-59.4|0.781
73855183|NCT01252186|147257185|SUPERIORITY_OR_OTHER||Treatment Difference|-12.49||||0.843|TWO_SIDED|95.0|-136.4|111.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||111.4|-136.4|0.843
73855184|NCT01252186|147257185|SUPERIORITY_OR_OTHER||Treatment Difference|58.3||||0.376|TWO_SIDED|95.0|-71.3|187.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||187.9|-71.3|0.376
73855185|NCT01252186|147257186|SUPERIORITY_OR_OTHER||Treatment Difference|-4.01||||0.731|TWO_SIDED|95.0|-27.0|19.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||19.0|-27.0|0.731
73855186|NCT01252186|147257186|SUPERIORITY_OR_OTHER||Treatment Difference|130.15|||<|0.001|TWO_SIDED|95.0|106.2|154.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||154.1|106.2|<0.001
74025308|NCT01416181|147603812|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the active and placebo groups at Week 156 compared to Week 108 is based on negative binomial regression model, adjusted for baseline EDSS (\<=5.5 or \>=6) and baseline volume of T2 lesions.|negative binomial regression model|natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment||Week 156||||< 0.0001
74025309|NCT02907944|147603861|SUPERIORITY||Odds Ratio (OR)|1.09||||0.55|TWO_SIDED|95.0|0.82|1.45|||Generalized Estimating Equation|||||1.45|0.82|0.55
73855187|NCT04283994|147257190|SUPERIORITY||Risk Difference (RD)|0.114||||0.023|TWO_SIDED|95.0|0.03|0.197||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.197|0.030|0.023
73905093|NCT02017171|147340667|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.5|2.9||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Hazard ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||2.9|0.5|
74025310|NCT02907944|147603861|SUPERIORITY||Odds Ratio (OR)|1.76||||0.09|TWO_SIDED|95.0|0.92|3.37|||Generalized Estimating Equation|||||3.37|0.92|0.09
74025311|NCT02907944|147603861|SUPERIORITY||Odds Ratio (OR)|1.4||||0.001|TWO_SIDED|95.0|1.14|1.71|||Generalized Estimating Equation|||||1.71|1.14|0.001
74025312|NCT02907944|147603862|SUPERIORITY||Odds Ratio (OR)|1.08||||0.59|TWO_SIDED|95.0|0.81|1.45|||Generalized Estimating Equation|||||1.45|0.81|0.59
74025313|NCT02907944|147603862|SUPERIORITY||Odds Ratio (OR)|1.77||||0.11|TWO_SIDED|95.0|0.88|3.55|||Generalized Estimating Equation|||||3.55|0.88|0.11
73962880|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|1.1||||0.4966|TWO_SIDED|90.0|-18.4|20.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||20.4|-18.4|0.4966
73962881|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|10.9||||0.2753|TWO_SIDED|90.0|-9.3|30.1|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||30.1|-9.3|0.2753
74025314|NCT02907944|147603862|SUPERIORITY||Odds Ratio (OR)|1.35||||0.005|TWO_SIDED|95.0|1.09|1.66|||Generalized Estimating Equation|||||1.66|1.09|0.005
74025315|NCT02559505|147603875|OTHER|||||||0.005||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.005
74025316|NCT02559505|147603875|OTHER|||||||0.024||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.024
74025317|NCT02559505|147603876|OTHER|||||||0.408||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.408
74025318|NCT02559505|147603876|OTHER|||||||0.004||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.004
74025319|NCT02559505|147603877|OTHER|||||||0.991||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.991
74025320|NCT02559505|147603877|OTHER|||||||0.334||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.334
74025321|NCT02559505|147603878|OTHER|||||||0.226||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.226
73855188|NCT04283994|147257190|SUPERIORITY||Risk Difference (RD)|0.068||||0.294|TWO_SIDED|95.0|-0.013|0.15||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bidirectional intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.150|-0.013|0.294
73855189|NCT04283994|147257190|SUPERIORITY||Risk Difference (RD)|-0.045||||0.952|TWO_SIDED|95.0|-0.134|0.044||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bidirectional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.044|-0.134|0.952
73855190|NCT04283994|147257197|SUPERIORITY||Mean Difference (Final Values)|-0.3||||1.65|TWO_SIDED|95.0|-1.3|0.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.7|-1.3|1.650
73855191|NCT04283994|147257197|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.985|TWO_SIDED|95.0|-1.6|0.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.5|-1.6|0.985
73962882|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|16.2||||0.1036|TWO_SIDED|90.0|-4.2|35.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||35.7|-4.2|0.1036
73962883|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|20.6||||0.0457|TWO_SIDED|90.0|0.4|39.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||39.6|0.4|0.0457
74025322|NCT02559505|147603878|OTHER|||||||0.036||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.036
74025323|NCT02559505|147603879|OTHER|||||||0.68||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.680
74025324|NCT02559505|147603879|OTHER|||||||0.002||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.002
74025325|NCT00698516|147603883|SUPERIORITY_OR_OTHER||Greenwood variance|65.0|STANDARD_ERROR_OF_MEAN|7.07||0.017|TWO_SIDED|95.0|49.3|76.9||Historical data in target population showed 3-month PFS rates of \<=50%. Oral topotecan with IV bevacizumab would provide clinically meaningful improvement in 3-month PFS if it could demonstrate a 40% improvement relative to the historical data.|Z statistic|Z statistic was used to reject the null hypothesis provided Z\>=1.65, where Z = (KM estimate at 3 months - null hypothesis value \[50%\])/Greenwood SE.||||76.9|49.3|0.017
74025326|NCT02586805|147603897|OTHER||% change in mean rate (vs placebo)|-75.609|||<|0.001|TWO_SIDED|95.0|-84.65|-61.243||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-61.243|-84.650|<0.001
73962884|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
73962885|NCT03903822|147461907|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
73962886|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|3.3||||0.245|TWO_SIDED|90.0|-5.4|14.9|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||14.9|-5.4|0.2450
73962887|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|3.1||||0.2575|TWO_SIDED|90.0|-5.3|14.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||14.0|-5.3|0.2575
73962888|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|16.1||||0.0087|TWO_SIDED|90.0|5.7|31.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||31.0|5.7|0.0087
73962889|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|10.7||||0.0392|TWO_SIDED|90.0|0.8|25.4|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||25.4|0.8|0.0392
73962890|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-11.2|11.2|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||11.2|-11.2|1.0000
73962891|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|7.8||||0.1528|TWO_SIDED|90.0|-4.9|22.5|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||22.5|-4.9|0.1528
73962892|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|0.9||||0.4989|TWO_SIDED|90.0|-12.7|15.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||15.2|-12.7|0.4989
73962893|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|0.3||||0.5419|TWO_SIDED|90.0|-13.6|14.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||14.2|-13.6|0.5419
73855192|NCT04283994|147257197|SUPERIORITY||Mean Difference (Final Values)|0.2||||2.155|TWO_SIDED|95.0|-1.0|1.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.4|-1.0|2.155
73855193|NCT04283994|147257198|SUPERIORITY||Mean Difference (Final Values)|0.7||||2.169|TWO_SIDED|95.0|-3.1|4.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis,|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||4.4|-3.1|2.169
73962894|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|10.3||||0.1362|TWO_SIDED|90.0|-5.0|26.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||26.2|-5.0|0.1362
73855194|NCT04283994|147257198|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.391|TWO_SIDED|95.0|-7.5|1.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.0|-7.5|0.391
73855195|NCT04283994|147257198|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.21|TWO_SIDED|95.0|-0.3|8.2||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||8.2|-0.3|0.210
73855196|NCT04283994|147257199|SUPERIORITY||Mean Difference (Final Values)|0.8||||1.01|TWO_SIDED|95.0|-0.8|2.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||2.4|-0.8|1.010
73855197|NCT04283994|147257199|SUPERIORITY||Mean Difference (Final Values)|0.0||||2.923|TWO_SIDED|95.0|-1.7|1.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.7|-1.7|2.923
73855198|NCT04283994|147257199|SUPERIORITY||Mean Difference (Final Values)|0.8||||1.034|TWO_SIDED|95.0|-0.9|2.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||2.5|-0.9|1.034
73962895|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|15.9||||0.0541|TWO_SIDED|90.0|-0.4|33.9|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||33.9|-0.4|0.0541
73962896|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|3.3||||0.3945|TWO_SIDED|90.0|-12.0|19.5|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||19.5|-12.0|0.3945
73962897|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|23.3||||0.0201|TWO_SIDED|90.0|3.9|41.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||41.8|3.9|0.0201
73962898|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|11.2||||0.1372|TWO_SIDED|90.0|-5.4|28.2|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||28.2|-5.4|0.1372
73855199|NCT04283994|147257200|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.384|TWO_SIDED|95.0|-1.0|7.9||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||7.9|-1.0|0.384
73855200|NCT04283994|147257200|SUPERIORITY||Mean Difference (Final Values)|-1.2||||1.923|TWO_SIDED|95.0|-6.1|3.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.7|-6.1|1.923
73855201|NCT04283994|147257200|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.166|TWO_SIDED|95.0|-0.1|9.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||9.4|-0.1|0.166
73855202|NCT04283994|147257201|SUPERIORITY||Risk Difference (RD)|-0.11||||0.16|TWO_SIDED|95.0|-0.23|0.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.00|-0.23|0.160
73855203|NCT04283994|147257201|SUPERIORITY||Risk Difference (RD)|-0.07||||0.652|TWO_SIDED|95.0|-0.18|0.04||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.04|-0.18|0.652
73855204|NCT04283994|147257201|SUPERIORITY||Risk Difference (RD)|-0.04||||1.39|TWO_SIDED|95.0|-0.16|0.07||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.07|-0.16|1.390
73855205|NCT04283994|147257202|SUPERIORITY||Risk Difference (RD)|0.05||||1.192|TWO_SIDED|95.0|-0.06|0.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.16|-0.06|1.192
73855206|NCT04283994|147257202|SUPERIORITY||Risk Difference (RD)|0.01||||2.698|TWO_SIDED|95.0|-0.11|0.12||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.12|-0.11|2.698
73855207|NCT04283994|147257202|SUPERIORITY||Risk Difference (RD)|0.04||||1.477|TWO_SIDED|95.0|-0.08|0.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.16|-0.08|1.477
73905094|NCT02017171|147340668|SUPERIORITY||Ratio (Final Values)|1.4|||||TWO_SIDED|95.0|1.0|1.8||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||1.8|1.0|
73905095|NCT02017171|147340669|SUPERIORITY||Ratio (Final Values)|1.3|||||TWO_SIDED|95.0|1.0|1.6||For secondary outcomes, 95% confidence intervals are reported, without P values.|||||Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|1.6|1.0|
73905096|NCT02017171|147340670|SUPERIORITY||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|0.8|4.5||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Hazard Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||4.5|0.8|
73905097|NCT03091777|147340671|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
73905098|NCT03091777|147340671|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
73905099|NCT02314143|147340674|OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.224|4.459|||Cochran-Mantel-Haenszel||The odds ratio for dabrafenib followed by combination therapy versus combination therapy has been presented.|||4.459|0.224|1.0000
73905100|NCT02314143|147340674|OTHER||Odds Ratio (OR)|1.97||||0.4216|TWO_SIDED|95.0|0.382|10.166|||Cochran-Mantel-Haenszel||The odds ratio for trametinib followed by combination therapy versus combination therapy has been presented.|||10.166|0.382|0.4216
73905101|NCT00708071|147340686|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25||||0.143||95.0|-0.04|0.49|||McNemar||Difference in Proportions = SoC - FS VH S/D 4|||0.49|-0.04|0.143
73905102|NCT00708071|147340687|SUPERIORITY_OR_OTHER||Difference in proportions|0.31|||||TWO_SIDED|90.0|0.12|0.48|||||Difference in proportions = SoC - FS VH S/D 4|||0.48|0.12|
73905103|NCT00708071|147340688|SUPERIORITY_OR_OTHER||Difference in proportions|0.111|||||TWO_SIDED|90.0|-0.11|0.32|||||Difference in proportions = SoC - FS VH S/D 4|||0.32|-0.11|
74025327|NCT02586805|147603897|OTHER||% change in mean rate (vs placebo)|-73.271|||<|0.001|TWO_SIDED|95.0|-82.379|-59.456||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-59.456|-82.379|<0.001
73905104|NCT00708071|147340689|SUPERIORITY_OR_OTHER||Difference in proportions|-0.032|||||TWO_SIDED|90.0|-0.24|0.18|||||Difference in proportions = SoC - FS VH S/D 4|||0.18|-0.24|
73905105|NCT00708071|147340690|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|90.0|-0.21|0.21|||||Difference in proportions = SoC - FS VH S/D 4|||0.21|-0.21|
73905106|NCT00708071|147340691|SUPERIORITY_OR_OTHER||Difference in proportions|0.038|||||TWO_SIDED|90.0|-0.17|0.24|||||Difference in proportions = SoC - FS VH S/D 4|||0.24|-0.17|
73905107|NCT00708071|147340692|SUPERIORITY_OR_OTHER|||||||0.645|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.645
73905108|NCT00708071|147340693|SUPERIORITY_OR_OTHER|||||||0.103||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.103
73905109|NCT00708071|147340694|SUPERIORITY_OR_OTHER|||||||0.833||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.833
73905110|NCT00708071|147340695|SUPERIORITY_OR_OTHER|||||||0.501||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.501
73905111|NCT00708071|147340696|SUPERIORITY_OR_OTHER|||||||0.247||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.247
73905112|NCT00708071|147340697|SUPERIORITY_OR_OTHER|||||||0.715||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.715
73905113|NCT00708071|147340699|SUPERIORITY_OR_OTHER|||||||0.754||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.754
73905114|NCT00708071|147340700|SUPERIORITY_OR_OTHER|||||||0.388||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.388
73905115|NCT00708071|147340701|SUPERIORITY_OR_OTHER|||||||0.234||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.234
73905116|NCT00708071|147340702|SUPERIORITY_OR_OTHER|||||||0.688||90.0||||Two-sided Wilcoxon paired sample tests|Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.688
73905117|NCT00708071|147340703|SUPERIORITY_OR_OTHER|||||||0.625||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.625
73905118|NCT00708071|147340704|SUPERIORITY_OR_OTHER|||||||0.688||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.688
73905119|NCT00708071|147340705|SUPERIORITY_OR_OTHER|||||||1||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||1.000
73905120|NCT00708071|147340706|SUPERIORITY_OR_OTHER|||||||0.521||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.521
73905121|NCT00708071|147340707|SUPERIORITY_OR_OTHER|||||||0.324||90.0||||alpha = 10%|Two-sided Wilcoxon paired sample tests|||||||0.324
73905122|NCT00708071|147340708|SUPERIORITY_OR_OTHER|||||||0.661||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.661
73905123|NCT00708071|147340709|SUPERIORITY_OR_OTHER|||||||1||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||1.000
73905124|NCT00708071|147340710|SUPERIORITY_OR_OTHER|||||||0.699||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.699
73905125|NCT00708071|147340713|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||two-sided paired t-test|alpha = 5%||||||0.0010
73905126|NCT00708071|147340715|SUPERIORITY_OR_OTHER||Difference in proportions|0.182||||0.014|TWO_SIDED|95.0|0.04|0.34|||McNemar's test of paired proportions|Alpha = 5%|Difference in Proportions = (Number of SoC Participants with Hematoma/Seroma) - (Number of FS VH S/D 4 Participants with Hematoma/Seroma)|||0.34|0.04|0.014
73905127|NCT00729924|147340723|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The hypothesis was that the ratio of the 4-hour CSF concentration value to the partial plasma area-under-the-curve 0-4h value would differ between participants with ABCB1 C/C and T/T genotypes.||||0.43
73905128|NCT00729924|147340724|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||We explored post-hoc whether the ratio of the 4-hour CSF concentration value to the 2-hour plasma concentration differs between participants with ABCB1 C/C and T/T genotypes.||||0.43
73905129|NCT04233034|147340759|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.89|TWO_SIDED|95.0|-0.11|0.1|||Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.10|-0.11|0.89
73905130|NCT04233034|147340759|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.04|TWO_SIDED|95.0|0.01|0.27|||Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.27|0.01|0.04
73905131|NCT04233034|147340760|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.8|TWO_SIDED|95.0|-0.1|0.08||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.08|-0.10|0.80
73905132|NCT04233034|147340760|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.8|TWO_SIDED|95.0|-0.08|0.13||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.13|-0.08|0.80
73905133|NCT04233034|147340760|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8|TWO_SIDED|95.0|-0.13|0.09||P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.09|-0.13|0.80
73855208|NCT04283994|147257203|SUPERIORITY||Mean Difference (Final Values)|-0.57||||2.293|TWO_SIDED|95.0|-4.3|3.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||3.16|-4.30|2.293
73855209|NCT04283994|147257203|SUPERIORITY||Mean Difference (Final Values)|-0.48||||2.381|TWO_SIDED|95.0|-4.11|3.14||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.14|-4.11|2.381
73855210|NCT04283994|147257203|SUPERIORITY||Mean Difference (Final Values)|-0.09||||2.893|TWO_SIDED|95.0|-3.86|3.69||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.69|-3.86|2.893
73855211|NCT04283994|147257204|SUPERIORITY||Risk Difference (RD)|0.0||||2.829|TWO_SIDED|95.0|-0.13|0.12||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.12|-0.13|2.829
73855212|NCT04283994|147257204|SUPERIORITY||Risk Difference (RD)|0.11||||0.188|TWO_SIDED|95.0|-0.01|0.24||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.24|-0.01|0.188
73855213|NCT04283994|147257204|SUPERIORITY||Risk Difference (RD)|-0.12||||0.19|TWO_SIDED|95.0|-0.24|0.01||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.01|-0.24|0.190
73855214|NCT04283994|147257205|SUPERIORITY||Risk Difference (RD)|0.03||||1.994|TWO_SIDED|95.0|-0.09|0.14||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.14|-0.09|1.994
73855215|NCT04283994|147257205|SUPERIORITY||Risk Difference (RD)|0.07||||0.771|TWO_SIDED|95.0|-0.05|0.19||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.19|-0.05|0.771
73855216|NCT04283994|147257205|SUPERIORITY||Risk Difference (RD)|-0.04||||1.447|TWO_SIDED|95.0|-0.17|0.08||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.08|-0.17|1.447
73905134|NCT04233034|147340760|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.69|TWO_SIDED|95.0|-0.09|0.13||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.13|-0.09|0.69
73905135|NCT04233034|147340760|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.08|TWO_SIDED|95.0|-0.02|0.25||P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.25|-0.02|0.08
73962899|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|3.5||||0.3924|TWO_SIDED|90.0|-11.6|19.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||19.1|-11.6|0.3924
73905136|NCT04233034|147340760|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.08|TWO_SIDED|95.0|-0.01|0.28||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.28|-0.01|0.08
73905137|NCT04233034|147340763|SUPERIORITY||Mean Difference (Final Values)|-25.0|||<|0.001|TWO_SIDED|95.0|-37.0|-14.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-14|-37|<0.001
73905138|NCT04233034|147340763|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.74|TWO_SIDED|95.0|-25.0|16.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||16|-25|0.74
73905139|NCT04233034|147340764|SUPERIORITY||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|10.0|22.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||22|10|<0.001
73905140|NCT04233034|147340764|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.74|TWO_SIDED|95.0|-9.0|13.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||13|-9|0.74
73905141|NCT04233034|147340765|SUPERIORITY||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|10.0|22.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||22|10|<0.001
73905142|NCT04233034|147340765|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.95|TWO_SIDED|95.0|-8.0|14.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||14|-8|0.95
73962900|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|20.1||||0.0311|TWO_SIDED|90.0|2.4|38.3|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||38.3|2.4|0.0311
73962901|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|20.0||||0.0392|TWO_SIDED|90.0|0.8|38.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||38.1|0.8|0.0392
73905143|NCT04233034|147340766|SUPERIORITY||Risk Difference (RD)|0.38|||<|0.001|TWO_SIDED|95.0|0.21|0.53|||Regression, Logistic|||||0.53|0.21|<0.001
73905144|NCT04233034|147340766|SUPERIORITY||Risk Difference (RD)|0.03||||0.79|TWO_SIDED|95.0|-0.26|0.32|||Regression, Logistic|||||0.32|-0.26|0.79
73905145|NCT04233034|147340768|SUPERIORITY||Mean Difference (Final Values)|-16.0|||<|0.001|TWO_SIDED|95.0|-22.0|-9.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-9|-22|<0.001
73905146|NCT04233034|147340768|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.74|TWO_SIDED|95.0|-13.0|9.0|||Mixed Models Analysis||Mean difference at 52 weeks (verapamil - placebo) adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||9|-13|0.74
73905147|NCT04233034|147340769|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.003|TWO_SIDED|95.0|-7.0|-1.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-1|-7|0.003
73905148|NCT04233034|147340769|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.74|TWO_SIDED|95.0|-6.0|4.0|||Mixed Models Analysis||Mean difference (verapamil - placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||4|-6|0.74
73905149|NCT04233034|147340770|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.23|TWO_SIDED|95.0|-0.04|0.17|||Regression, Linear||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.17|-0.04|0.23
73905150|NCT04233034|147340770|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.79|TWO_SIDED|95.0|-1.0|0.6|||Regression, Linear||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.6|-1.0|0.79
73962902|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|10.0||||0.1541|TWO_SIDED|90.0|-6.2|26.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||26.4|-6.2|0.1541
73962903|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|27.0||||0.0091|TWO_SIDED|90.0|6.8|45.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||45.4|6.8|0.0091
73962904|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|8.5||||0.2835|TWO_SIDED|90.0|-9.5|27.0|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||27.0|-9.5|0.2835
73962905|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|9.9||||0.27|TWO_SIDED|90.0|-8.7|27.8|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||27.8|-8.7|0.2700
73962906|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|17.3||||0.0662|TWO_SIDED|90.0|-1.4|36.2|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||36.2|-1.4|0.0662
73962907|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|31.8||||0.005|TWO_SIDED|90.0|9.2|50.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||50.4|9.2|0.0050
73962908|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|20.0||||0.0302|TWO_SIDED|90.0|2.2|38.3|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||38.3|2.2|0.0302
73962909|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|27.0||||0.0091|TWO_SIDED|90.0|6.8|45.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||45.4|6.8|0.0091
73962910|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|11.8||||0.1561|TWO_SIDED|90.0|-6.5|30.2|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||30.2|-6.5|0.1561
73962911|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|16.2||||0.0753|TWO_SIDED|90.0|-2.7|34.8|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||34.8|-2.7|0.0753
73962912|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|27.0||||0.0108|TWO_SIDED|90.0|5.7|46.0|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||46.0|5.7|0.0108
73962913|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|31.8||||0.005|TWO_SIDED|90.0|9.2|50.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||50.4|9.2|0.0050
73962914|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|16.7||||0.0775|TWO_SIDED|90.0|-2.9|35.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||35.7|-2.9|0.0775
73962915|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|24.1||||0.0243|TWO_SIDED|90.0|3.4|43.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||43.4|3.4|0.0243
73962916|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|20.9||||0.0234|TWO_SIDED|90.0|3.5|38.8|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||38.8|3.5|0.0234
73962917|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|12.8||||0.1134|TWO_SIDED|90.0|-2.8|29.3|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||29.3|-2.8|0.1134
73962918|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|10.3||||0.1362|TWO_SIDED|90.0|-5.0|26.2|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||26.2|-5.0|0.1362
73962919|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|12.3||||0.1029|TWO_SIDED|90.0|-3.4|29.8|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||29.8|-3.4|0.1029
73962920|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-17.9|17.9|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||17.9|-17.9|1.0000
73962921|NCT03903822|147461908|SUPERIORITY||Risk Difference (RD)|-12.6||||0.8972|TWO_SIDED|90.0|-28.8|3.5|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||3.5|-28.8|0.8972
73962922|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-0.5|STANDARD_ERROR_OF_MEAN|8.33||0.4781|TWO_SIDED|90.0|-14.2|13.3|||Mixed Model Repeated Measure|||At Week 1: Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||13.3|-14.2|0.4781
73962923|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-13.8|STANDARD_ERROR_OF_MEAN|8.47||0.0522|TWO_SIDED|90.0|-27.8|0.2|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||0.2|-27.8|0.0522
73962924|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-17.5|STANDARD_ERROR_OF_MEAN|8.37||0.0187|TWO_SIDED|90.0|-31.4|-3.7|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-3.7|-31.4|0.0187
73962925|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-20.6|STANDARD_ERROR_OF_MEAN|8.45||0.008|TWO_SIDED|90.0|-34.5|-6.6|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-6.6|-34.5|0.0080
73962926|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-25.0|STANDARD_ERROR_OF_MEAN|14.17||0.0401|TWO_SIDED|90.0|-48.6|-1.5|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-1.5|-48.6|0.0401
73962927|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-25.5|STANDARD_ERROR_OF_MEAN|14.25||0.0379|TWO_SIDED|90.0|-49.2|-1.9|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-1.9|-49.2|0.0379
73962928|NCT03903822|147461909|SUPERIORITY||LS Mean difference|8.1|STANDARD_ERROR_OF_MEAN|11.01||0.7678|TWO_SIDED|90.0|-10.1|26.3|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.||26.3|-10.1|0.7678
73962929|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-22.8|STANDARD_ERROR_OF_MEAN|10.94||0.0193|TWO_SIDED|90.0|-40.9|-4.7|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-4.7|-40.9|0.0193
73962930|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-28.3|STANDARD_ERROR_OF_MEAN|10.95||0.0052|TWO_SIDED|90.0|-46.5|-10.2|||Mixed Model Repeated Measure|||At Week 2:MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-10.2|-46.5|0.0052
73962931|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-23.7|STANDARD_ERROR_OF_MEAN|11.03||0.0164|TWO_SIDED|90.0|-42.0|-5.5|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-5.5|-42.0|0.0164
73962932|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-31.7|STANDARD_ERROR_OF_MEAN|9.72||0.0008|TWO_SIDED|90.0|-47.8|-15.6|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.6|-47.8|0.0008
73962933|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-40.6|STANDARD_ERROR_OF_MEAN|9.86|<|0.0001|TWO_SIDED|90.0|-57.0|-24.3|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-24.3|-57.0|<0.0001
73962934|NCT03903822|147461909|SUPERIORITY||LS Mean difference|3.9|STANDARD_ERROR_OF_MEAN|12.09||0.6269|TWO_SIDED|90.0|-16.1|23.9|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||23.9|-16.1|0.6269
73962935|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-33.5|STANDARD_ERROR_OF_MEAN|11.87||0.0027|TWO_SIDED|90.0|-53.1|-13.8|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-13.8|-53.1|0.0027
73962936|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-38.8|STANDARD_ERROR_OF_MEAN|11.89||0.0007|TWO_SIDED|90.0|-58.5|-19.2|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-19.2|-58.5|0.0007
74025328|NCT02586805|147603897|OTHER||% change in mean rate (vs placebo)|-86.921|||<|0.001|TWO_SIDED|95.0|-92.828|-76.15||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-76.150|-92.828|<0.001
74025329|NCT02586805|147603898|OTHER||% change in mean rate (vs placebo)|-80.842|||<|0.001|TWO_SIDED|95.0|-89.169|-66.114||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-66.114|-89.169|<0.001
74025330|NCT02586805|147603898|OTHER||% change in mean rate (vs placebo)|-74.169|||<|0.001|TWO_SIDED|95.0|-83.733|-58.983||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-58.983|-83.733|<0.001
74025331|NCT02586805|147603898|OTHER||% change in mean rate (vs placebo)|-87.299|||<|0.001|TWO_SIDED|95.0|-93.494|-75.204||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-75.204|-93.494|<0.001
74025332|NCT02586805|147603899|OTHER||% change in mean rate (vs placebo)|-70.497|||<|0.001|TWO_SIDED|95.0|-82.696|-49.699||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-49.699|-82.696|<0.001
74025333|NCT02586805|147603899|OTHER||% change in mean rate (vs placebo)|-73.285|||<|0.001|TWO_SIDED|95.0|-84.316|-54.496||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-54.496|-84.316|<0.001
74025334|NCT02586805|147603899|OTHER||% change in mean rate (vs placebo)|-83.394|||<|0.001|TWO_SIDED|95.0|-91.618|-67.099||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-67.099|-91.618|<0.001
74025335|NCT02586805|147603900|OTHER||% change in mean rate (vs placebo)|-77.622|||<|0.001|TWO_SIDED|95.0|-86.253|-63.572||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-63.572|-86.253|<0.001
73855217|NCT04283994|147257208|SUPERIORITY||Risk Difference (RD)|-0.012||||1.836|TWO_SIDED|95.0|-0.058|0.034||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.034|-0.058|1.836
73855218|NCT04283994|147257208|SUPERIORITY||Risk Difference (RD)|0.021||||1.25|TWO_SIDED|95.0|-0.03|0.073||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.073|-0.030|1.250
73855219|NCT04283994|147257208|SUPERIORITY||Risk Difference (RD)|-0.033||||0.581|TWO_SIDED|95.0|-0.084|0.017||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.017|-0.084|0.581
74025336|NCT02586805|147603900|OTHER||% change in mean rate (vs placebo)|-75.377|||<|0.001|TWO_SIDED|95.0|-84.115|-61.833||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-61.833|-84.115|<0.001
74025337|NCT02586805|147603900|OTHER||% change in mean rate (vs placebo)|-89.008|||<|0.001|TWO_SIDED|95.0|-94.325|-78.707||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-78.707|-94.325|<0.001
74025338|NCT01121406|147603915|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier DC rates|-12.5|||||TWO_SIDED|95.0|-31.1|6.0|||||"95% CI using Greenwood´s variance estimate.~Volasertib (BI 6727) minus Cytotoxic."|Kaplan Meier estimates and confidence intervals (CI) were calculated using Greenwood's variance estimate within each treatment arm and the asymptotic CI for the difference in the rates found. The time was censored in those cases where there was no death or progression until the last trial visit||6.0|-31.1|
73905151|NCT04233034|147340771|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.39|TWO_SIDED|95.0|-0.3|0.7|||Regression, Linear||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.7|-0.3|0.39
73905152|NCT04233034|147340771|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.74|TWO_SIDED|95.0|-1.0|0.6|||Regression, Linear||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.6|-1.0|0.74
73905153|NCT04233034|147340773|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-0.3|-1.1|<0.001
73905154|NCT04233034|147340773|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.65|TWO_SIDED|95.0|-1.0|0.4|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.4|-1.0|0.65
73905155|NCT04233034|147340776|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.07|TWO_SIDED|95.0|-0.01|0.2|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.20|-0.01|0.07
73905156|NCT04233034|147340776|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.52|TWO_SIDED|95.0|-0.3|0.05|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.05|-0.30|0.52
73905157|NCT02791399|147340787|EQUIVALENCE|Our analysis examined the estimated averages for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-1.12|||<|0.05|TWO_SIDED|95.0|-2.45|0.2|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||0.20|-2.45|<0.05
73905158|NCT02791399|147340788|EQUIVALENCE|Our analysis examined the estimated probabilities for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-0.04|||<|0.05|TWO_SIDED|95.0|-0.15|0.06|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||0.06|-0.15|<0.05
73905159|NCT02791399|147340789|NON_INFERIORITY|Pain intensity and pain-related function were tested in non-inferiority analyses, as we hypothesized that the ISOT intervention would not negatively impact pain or function. One-half SD difference in change was considered the appropriate non-inferiority limit.|Non-inferiority analysis|1.6|||||TWO_SIDED|||||||||||||
73905160|NCT02791399|147340790|EQUIVALENCE|This analysis is comparing estimated averages and probabilities for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-1.99|||<|0.05|TWO_SIDED|95.0|-5.83|1.85|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||1.85|-5.83|<0.05
73905161|NCT02791399|147340791|EQUIVALENCE|Our analysis examined the estimated averages for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|1.03|||<|0.05|TWO_SIDED|95.0|-6.73|8.8|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||8.80|-6.73|<0.05
73905162|NCT01865084|147340807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.307||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis|||||||0.307
73905163|NCT01865084|147340807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.538||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis|||||||0.538
73905164|NCT03693170|147340814|OTHER|||||||||||||||||"The null hypothesis that the true response rate is 30% will be tested against a one-sided alternative.~The cORR will be provided with a corresponding Clopper-Pearson (exact) binomial 95% CI for the Efficacy Set.~This design yields a 1-sided type I error rate equal to 1.6% and power of 80% when the true response rate is 45%."|If 37 or more confirmed responses were observed in the 90 treated subjects with a centrally confirmed BRAFV600E mutation, corresponding to a lower limit of Clopper-Pearson (exact) binomial 95% CI exceeding 30%, the study was considered to have met its primary endpoint. If more than 90 subjects were enrolled, the lower limit of Clopper-Pearson was to be used for decision.|||
73905165|NCT03402659|147340831|OTHER||Mean Difference (Final Values)|-0.06098|STANDARD_ERROR_OF_MEAN|0.105548||0.564|TWO_SIDED|95.0|-0.26973|0.14777|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||0.14777|-0.26973|0.564
74025339|NCT01121406|147603916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.66|1.53|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"|||1.53|0.66|
74025340|NCT01121406|147603917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.63|1.42|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"|||1.42|0.63|
74025341|NCT01121406|147603920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.73|1.7|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.70|0.73|
74025342|NCT01121406|147603921|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.4|1.61|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.61|0.40|
74084986|NCT03239496|147723617|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
73905166|NCT03402659|147340832|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.72||0.823|TWO_SIDED|95.0|-6.0|4.8|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||4.8|-6.0|0.823
73905167|NCT03402659|147340833|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.806|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||0.6|-0.4|0.806
73905168|NCT03402659|147340834|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.39||0.489|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||0.5|-1.0|0.489
73905169|NCT03402659|147340835|OTHER||Mean Difference (Final Values)|-18.8|STANDARD_ERROR_OF_MEAN|8.6||0.031|TWO_SIDED|95.0|-35.8|-1.8|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||-1.8|-35.8|0.031
73905170|NCT03402659|147340836|OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.79||0.012|TWO_SIDED|95.0|-3.6|-0.5|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||-0.5|-3.6|0.012
73905171|NCT03402659|147340837|OTHER||Mean Difference (Final Values)|-117.4|STANDARD_ERROR_OF_MEAN|314.0||0.709|TWO_SIDED|95.0|-738.9|504.2|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||504.2|-738.9|0.709
73905172|NCT03402659|147340838|OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|16.03||0.192|TWO_SIDED|95.0|-52.7|10.7|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||10.7|-52.7|0.192
73905173|NCT03402659|147340839|OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|11.43||0.068|TWO_SIDED|95.0|-43.6|1.6|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||1.6|-43.6|0.068
73905174|NCT03402659|147340840|OTHER||Mean Difference (Final Values)|-110.1|STANDARD_ERROR_OF_MEAN|77.11||0.156|TWO_SIDED|95.0|-262.7|42.4|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||42.4|-262.7|0.156
73905175|NCT03402659|147340841|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.59|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||0.0|-0.0|0.590
73905176|NCT01442038|147340842|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.948||||0.48|TWO_SIDED|95.0|0.818|1.099||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying percutaneous coronary intervention (PCI): acute coronary syndrome (ACS) versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.099|0.818|0.48
73905177|NCT01442038|147340843|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.4|TWO_SIDED|95.0|0.244|1.691||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.691|0.244|0.40
73905178|NCT01442038|147340844|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.82|TWO_SIDED|95.0|0.579|1.994||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.994|0.579|0.82
73905179|NCT01442038|147340845|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.968||||0.81|TWO_SIDED|95.0|0.745|1.256||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.256|0.745|0.81
73905180|NCT03646643|147340863|SUPERIORITY||Hazard Ratio (HR)|0.12||||0.047|TWO_SIDED|95.0|0.02|0.97||A priori threshold \<0.05. Multiple comparisons adjustments: not needed.|Log Rank||The distal CS to LA connection elimination group had fewer recurrences (6.7%) compared with the standard group (46.7%), which translated to an 88% lower hazard of recurrence compared with the standard group.|Power calculation: assuming alpha 0.05, power 0.8, 1:1 randomization, and estimated relative risk of 14.4 for AF susceptibility with rate-dependent CS-LA conduction block, we anticipated a minimum sample size of 6 patients per group would be necessary to detect a difference using the log-rank test. Additional patients were recruited to account for potential losses to follow-up and a smaller detectable difference.||0.97|0.02|0.047
73905181|NCT04131556|147340864|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least square means|67.76|||||TWO_SIDED|90.0|59.5|77.16|||ANOVA|||||77.16|59.50|
74025343|NCT01121406|147603922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.37|1.65|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.65|0.37|
74025344|NCT01121406|147603923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.39|1.93|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.93|0.39|
74025345|NCT01121406|147603924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.33|1.47|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.47|0.33|
74025346|NCT01121406|147603925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27|||||TWO_SIDED|95.0|0.09|0.77|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||0.77|0.09|
74025347|NCT02750410|147603979|SUPERIORITY||LS mean percent difference|-1.5|||<|0.001|TWO_SIDED|95.0|-1.73|-1.28|||Mixed Models Analysis|||||-1.28|-1.73|<0.001
74025348|NCT02750410|147603980|SUPERIORITY||Odds Ratio (OR)|0.117||||0.003|TWO_SIDED|95.0|0.028|0.479|||Regression, Logistic|||analysis was based on repeated measures logistic regression||0.479|0.028|0.003
74025349|NCT02750410|147603981|SUPERIORITY||LS mean difference|-30.14|||<|0.001|TWO_SIDED|95.0|-41.37|-18.91|||Mixed Models Analysis|||||-18.91|-41.37|<0.001
74025350|NCT02750410|147603982|SUPERIORITY||LS mean difference|-26.59|||<|0.001|TWO_SIDED|95.0|-36.39|-16.78|||t-test, 2 sided|||Prebreakfast BG||-16.78|-36.39|<0.001
74025351|NCT02750410|147603982|SUPERIORITY||LS mean difference|-45.38|||<|0.001|TWO_SIDED|95.0|-61.77|-29.0|||t-test, 2 sided|||Breakfast 2-hour PPBG||-29.00|-61.77|<0.001
74025352|NCT02750410|147603982|SUPERIORITY||LS mean difference|-36.82|||<|0.001|TWO_SIDED|95.0|-49.2|-24.45|||t-test, 2 sided|||Prelunch BG||-24.45|-49.20|<0.001
74025353|NCT02750410|147603982|SUPERIORITY||LS mean difference|-50.16|||<|0.001|TWO_SIDED|95.0|-67.85|-32.46|||t-test, 2 sided|||Lunch 2-hour PPBG||-32.46|-67.85|<0.001
74025354|NCT02750410|147603982|SUPERIORITY||LS mean difference|-31.27|||<|0.001|TWO_SIDED|95.0|-44.05|-18.48|||t-test, 2 sided|||Predinner BG||-18.48|-44.05|<0.001
74025355|NCT02750410|147603982|SUPERIORITY||LS mean difference|-34.97|||<|0.001|TWO_SIDED|95.0|-52.55|-17.38|||t-test, 2 sided|||Dinner 2-hour PPBG||-17.38|-52.55|<0.001
74025356|NCT02750410|147603982|SUPERIORITY||LS mean difference|-41.45|||<|0.001|TWO_SIDED|95.0|-58.81|-24.09|||t-test, 2 sided|||Bedtime BG||-24.09|-58.81|<0.001
74025357|NCT02750410|147603983|SUPERIORITY||LS mean difference|0.1||||0.776|TWO_SIDED|95.0|-0.59|0.78|||Mixed Models Analysis|||||0.78|-0.59|0.776
74025358|NCT00500071|147604000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 1||||< 0.0001
74025359|NCT00500071|147604000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 2||||< 0.0001
74025360|NCT00500071|147604000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 3||||< 0.0001
74025361|NCT00500071|147604000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 4||||< 0.0001
74025362|NCT00500071|147604000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 5||||< 0.0001
74025363|NCT00500071|147604000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 6||||< 0.0001
74025364|NCT00500071|147604000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 7||||< 0.0001
74025365|NCT00500071|147604001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||||||< 0.0001
74025366|NCT00500071|147604004|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||||||< 0.0001
74025367|NCT00500071|147604005|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Global Executive Composite||||< 0.0001
74025368|NCT00500071|147604005|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Behavioral Recognition Index||||< 0.0001
74025369|NCT00500071|147604005|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Metacognition Index||||< 0.0001
74025370|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 2 between the two arms."|Difference in Change|-0.32||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 2 between the two arms"||||0.02
74025371|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean problems maintaining an erection score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in problems maintaining an erection score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean problems maintaining an erection score from period 1 to period 2 between the two arms"||||0.11
74025372|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 2 between the two arms"||||0.02
74025373|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 2 between the two arms"||||0.01
74025374|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean vomit score from period 1 to period 2 between the two arms."|Difference in Change|-0.28||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 2 between the two arms"||||0.01
74025375|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 2 between the two arms."|Difference in Change|-0.24||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 2 between the two arms"||||0.02
74025376|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean heartburn score from period 1 to period 2 between the two arms."|Difference in Change|-0.19||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 2 between the two arms"||||0.11
74025377|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 2 between the two arms."|Difference in Change|-0.16||||0.21|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 2 between the two arms"||||0.21
73905182|NCT04131556|147340864|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|62.29|||||TWO_SIDED|90.0|54.73|70.9|||ANOVA|||||70.90|54.73|
73905183|NCT04131556|147340865|OTHER||Median Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|90.0|0.75|1.75|||Wilcoxon signed rank test|||Statistical analysis of tmax was performed using a nonparametric test. The median difference of tmax between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||1.75|0.75|<.001
73905184|NCT04131556|147340865|OTHER||Median Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|90.0|0.75|1.25|||Wilcoxon signed rank test|||Statistical analysis of tmax was performed using a nonparametric test. The median difference of tmax between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||1.25|0.75|<.001
73905185|NCT04131556|147340866|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|81.27|||||TWO_SIDED|90.0|73.88|89.4|||ANOVA|||||89.40|73.88|
74025378|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean constipation score from period 1 to period 2 between the two arms."|Difference in Change|-0.14||||0.33|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 2 between the two arms"||||0.33
74025379|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean appetite change score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 2 between the two arms"||||0.46
74084987|NCT03239496|147723618|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
74084988|NCT03239496|147723619|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
73905186|NCT04131556|147340866|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|78.0|||||TWO_SIDED|90.0|70.92|85.79|||ANOVA|||||85.79|70.92|
73905187|NCT04131556|147340867|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|83.52|||||TWO_SIDED|90.0|76.12|91.64|||ANOVA|||||91.64|76.12|
73905188|NCT04131556|147340867|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|80.36|||||TWO_SIDED|90.0|73.26|88.16|||ANOVA|||||88.16|73.26|
73905189|NCT04131556|147340870|OTHER||Median Difference (Final Values)|0.13||||0.006|TWO_SIDED|90.0|0.13|0.25|||Wilcoxon signed rank test|||Statistical analysis of Tlag was performed using a nonparametric test. The median difference of Tlag between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||0.25|0.13|0.006
73905190|NCT04131556|147340870|OTHER||Median Difference (Final Values)|0.13||||0.011|TWO_SIDED|90.0|0.13|0.25|||Wilcoxon signed rank test|||Statistical analysis of Tlag was performed using a nonparametric test. The median difference of Tlag between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||0.25|0.13|0.011
73905191|NCT02545075|147340894|SUPERIORITY|||||||0.5059|||||||Chi-squared|One-sided p-value based on unstratified chi-square test||||||0.5059
73905192|NCT02545075|147340895|SUPERIORITY|||||||0.6202|||||||Chi-squared|One-sided unstratified chi-square||||||0.6202
73905193|NCT02545075|147340896|SUPERIORITY||Stratified cox proportional hazard model|1.13||||0.7267|TWO_SIDED|80.0|0.87|1.45|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c)||||1.45|0.87|0.7267
73905194|NCT02545075|147340897|SUPERIORITY||Stratified Cox proportional hazard|0.9||||0.2503|TWO_SIDED|80.0|0.71|1.15|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c) and BRAF mutation status as entered into the IVRS||||1.15|0.71|0.2503
73905195|NCT02545075|147340898|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|80.0|0.64|1.55|||Cochran-Mantel-Haenszel|||||1.55|0.64|0.9932
73905196|NCT02545075|147340899|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9738|TWO_SIDED|80.0|0.48|2.03|||Cochran-Mantel-Haenszel|||||2.03|0.48|0.9738
73905197|NCT00736879|147340905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.1672|<|0.0001|TWO_SIDED|95.0|-1.02|-0.37||Tested at alpha=0.019 applying Dunnett's adjustment|ANCOVA|||||-0.37|-1.02|<0.0001
73905198|NCT00736879|147340905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.1679|<|0.0001|TWO_SIDED|95.0|-1.07|-0.41|||ANCOVA|Tested at alpha=0.019 applying Dunnett's adjustment.||||-0.41|-1.07|<0.0001
73962937|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-32.1|STANDARD_ERROR_OF_MEAN|12.0||0.0041|TWO_SIDED|90.0|-51.9|-12.3|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-12.3|-51.9|0.0041
74084989|NCT00117806|147723625|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Chi-squared|||||||0.008
73962938|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-14.6|STANDARD_ERROR_OF_MEAN|11.61||0.1054|TWO_SIDED|90.0|-33.9|4.6|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||4.6|-33.9|0.1054
73962939|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-18.8|STANDARD_ERROR_OF_MEAN|11.62||0.0542|TWO_SIDED|90.0|-38.1|0.5|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||0.5|-38.1|0.0542
73905199|NCT00736879|147340905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.17|-0.5|||ANCOVA|Tested at alpha=0.019 applying Dunnett's adjustment.||||-0.50|-1.17|<0.0001
73905200|NCT00736879|147340906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.5481||0.0018|TWO_SIDED|95.0|-2.81|-0.65||Test was performed at alpha=0.05.|ANCOVA|||By applying sequential testing procedure, the testing was performed since the primary endpoint was significant.||-0.65|-2.81|0.0018
73905201|NCT00736879|147340906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.5474||0.0024|TWO_SIDED|95.0|-2.76|-0.6||Test was performed at alpha=0.05.|ANCOVA|||||-0.60|-2.76|0.0024
73905202|NCT00736879|147340906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.5598||0.0022|TWO_SIDED|95.0|-2.83|-0.63||Test was performed at alpha=0.05.|ANCOVA|||||-0.63|-2.83|0.0022
73905203|NCT00736879|147340907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.1|STANDARD_ERROR_OF_MEAN|5.859||0.0103|TWO_SIDED|95.0|-26.7|-3.6||Test was performed at alpha=0.05.|ANCOVA|||||-3.6|-26.7|0.0103
73905204|NCT00736879|147340907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|5.816|<|0.0001|TWO_SIDED|95.0|-37.2|-14.3||Test was performed at alpha=0.05.|ANCOVA|||||-14.3|-37.2|<0.0001
73905205|NCT00736879|147340907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.6|STANDARD_ERROR_OF_MEAN|5.962|<|0.0001|TWO_SIDED|95.0|-44.3|-20.8||Test was performed at alpha=0.05.|ANCOVA|||||-20.8|-44.3|<0.0001
73905206|NCT00736879|147340908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.1|STANDARD_ERROR_OF_MEAN|8.8681|<|0.0001|TWO_SIDED|95.0|-59.56|-24.61||Test was performed at alpha=0.05.|ANCOVA|||||-24.61|-59.56|<0.0001
73905207|NCT00736879|147340908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.1|STANDARD_ERROR_OF_MEAN|9.1963|<|0.0001|TWO_SIDED|95.0|-66.27|-30.03||Test was performed at alpha=0.05.|ANCOVA|||||-30.03|-66.27|<0.0001
73905208|NCT00736879|147340908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.6|STANDARD_ERROR_OF_MEAN|9.1796|<|0.0001|TWO_SIDED|95.0|-78.67|-42.5||Test was performed at alpha=0.05.|ANCOVA|||||-42.50|-78.67|<0.0001
73905209|NCT00736879|147340909|SUPERIORITY_OR_OTHER||percent difference|18.9|STANDARD_ERROR_OF_MEAN|7.38||0.0157|TWO_SIDED|95.0|3.6|34.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||34.3|3.6|0.0157
73905210|NCT00736879|147340909|SUPERIORITY_OR_OTHER||Percent Difference|8.8|STANDARD_ERROR_OF_MEAN|7.65||0.2512|TWO_SIDED|95.0|-6.2|23.8||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||23.8|-6.2|0.2512
73905211|NCT00736879|147340909|SUPERIORITY_OR_OTHER||Percent Difference|14.5|STANDARD_ERROR_OF_MEAN|8.069||0.0726|TWO_SIDED|95.0|-1.3|30.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||30.3|-1.3|0.0726
73905212|NCT00736879|147340910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.7954||0.3163|TWO_SIDED|95.0|-2.37|0.77||Test was performed at alpha=0.05.|ANCOVA|||||0.77|-2.37|0.3163
73905213|NCT00736879|147340910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.8154|||TWO_SIDED|95.0|-2.22|0.99|||ANCOVA|||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.||0.99|-2.22|
73905214|NCT00736879|147340910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.8238|||TWO_SIDED|95.0|-3.09|0.16|||ANCOVA|||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.||0.16|-3.09|
73905215|NCT01593722|147340968|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.68
73905216|NCT02788474|147341027|OTHER||Adjusted mean difference|-0.00066|STANDARD_ERROR_OF_MEAN|0.00282||0.8146|TWO_SIDED|95.0|-0.00621|0.00488||random coefficient regression (random slopes and intercepts) model including sex, age and height as covariates (Due to the low number of measurements per patient, baseline CRPM was included as a response rather than as a covariate in the analysis)|random coefficient regression|The Kenward-Roger approximation was used to estimate denominators degrees of freedom.|Difference calculated as Nintedanib minus Placebo|"The rate of change (slope) in blood CRPM was assumed to be linear in each subject over the 12 weeks of treatment. The intercepts and slopes were assumed to be normally distributed with arbitrary covariance matrix.~Since the distribution of the data was not normal, a log10 transformation was performed before conducting the statistical analyses.~Significance tests were based on least-square means using 2-sided 95% confidence intervals (2-sided α=0.05)."||0.00488|-0.00621|0.8146
73905217|NCT02788474|147341028|OTHER||slope estimate|22.001||||0.2084|TWO_SIDED|95.0|-11.83|57.58|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess the association between disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death) and the change in the Extracellular matrix (ECM) biomarker CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM and the monthly rate of change (slope) in blood CRPM in the first 12 weeks as covariates was applied for placebo-treated patients only to evaluate the potential of CRPM as a prognostic biomarker.||57.58|-11.83|0.2084
73905218|NCT02788474|147341028|OTHER||slope estimate|-45.566||||0.1537|TWO_SIDED|95.0|-109.55|16.37|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess how nintedanib treatment affected the association between disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death) and the change in CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM, the monthly rate of change (slope) in blood CRPM up to Week 12, treatment and treatment-CRPM slope interaction as covariates was applied.||16.37|-109.55|0.1537
74084990|NCT02339415|147723632|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.26|TWO_SIDED|95.0|-0.06|0.21|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.|||0.21|-0.06|0.26
73905219|NCT02788474|147341028|OTHER||Odds Ratio (OR)|0.769||||0.3116|TWO_SIDED|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the overall treatment regimen affected disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death), a logistic regression analysis including baseline blood CRPM and randomised treatment as covariates was applied.||1.27|0.46|0.3116
73962940|NCT03903822|147461909|SUPERIORITY||LS Mean difference|5.8|STANDARD_ERROR_OF_MEAN|12.12||0.6847|TWO_SIDED|90.0|-14.2|25.9|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||25.9|-14.2|0.6847
73962941|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-29.9|STANDARD_ERROR_OF_MEAN|11.82||0.0062|TWO_SIDED|90.0|-49.4|-10.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-10.3|-49.4|0.0062
73962942|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-32.0|STANDARD_ERROR_OF_MEAN|11.89||0.004|TWO_SIDED|90.0|-51.6|-12.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-12.3|-51.6|0.0040
73962943|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-30.8|STANDARD_ERROR_OF_MEAN|11.97||0.0054|TWO_SIDED|90.0|-50.6|-11.0|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-11.0|-50.6|0.0054
73962944|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-11.7|STANDARD_ERROR_OF_MEAN|9.35||0.1076|TWO_SIDED|90.0|-27.2|3.9|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||3.9|-27.2|0.1076
73962945|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-23.0|STANDARD_ERROR_OF_MEAN|9.42||0.0082|TWO_SIDED|90.0|-38.6|-7.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-7.3|-38.6|0.0082
73855220|NCT04283994|147257209|SUPERIORITY||Risk Difference (RD)|-0.039||||0.692|TWO_SIDED|95.0|-0.102|0.025||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.025|-0.102|0.692
73855221|NCT04283994|147257209|SUPERIORITY||Risk Difference (RD)|0.038||||0.887|TWO_SIDED|95.0|-0.033|0.109||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.109|-0.033|0.887
73855222|NCT04283994|147257209|SUPERIORITY||Risk Difference (RD)|-0.077||||0.08|TWO_SIDED|95.0|-0.145|-0.009||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||-0.009|-0.145|0.080
73855223|NCT04283994|147257210|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.293|TWO_SIDED|95.0|0.9|2.1||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis.|Hazard ratio = bi-directional intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||2.1|0.9|0.293
73855224|NCT04283994|147257210|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.027|TWO_SIDED|95.0|1.1|2.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis|Hazard ratio = clinician-facing intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||2.5|1.1|0.027
73855225|NCT04283994|147257210|SUPERIORITY||Hazard Ratio (HR)|0.8||||1.009|TWO_SIDED|95.0|0.6|1.2||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis.|Hazard ratio = bi-directional intervention / clinician-facing intervention. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||1.2|0.6|1.009
73855226|NCT04283994|147257211|SUPERIORITY||Mean Difference (Final Values)|-0.43||||1.366|TWO_SIDED|95.0|-1.55|0.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.70|-1.55|1.366
73855227|NCT04283994|147257211|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.978|TWO_SIDED|95.0|-1.73|0.58||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.58|-1.73|0.978
73855228|NCT04283994|147257211|SUPERIORITY||Mean Difference (Final Values)|0.15||||2.39|TWO_SIDED|95.0|-0.99|1.3||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.30|-0.99|2.390
73855229|NCT04283994|147257212|SUPERIORITY||Mean Difference (Final Values)|0.47||||1.125|TWO_SIDED|95.0|-0.57|1.51||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.51|-0.57|1.125
73855230|NCT04283994|147257212|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.258|TWO_SIDED|95.0|-0.13|1.94||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.94|-0.13|0.258
73855231|NCT04283994|147257212|SUPERIORITY||Mean Difference (Final Values)|-0.44||||1.267|TWO_SIDED|95.0|-1.5|0.63||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.63|-1.5|1.267
73855232|NCT04283994|147257213|SUPERIORITY||Mean Difference (Final Values)|0.32||||1.594|TWO_SIDED|95.0|-0.68|1.32||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.32|-0.68|1.594
73855233|NCT04283994|147257213|SUPERIORITY||Mean Difference (Final Values)|0.29||||1.803|TWO_SIDED|95.0|-0.79|1.36||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.36|-0.79|1.803
73855234|NCT04283994|147257213|SUPERIORITY||Mean Difference (Final Values)|0.03||||2.851|TWO_SIDED|95.0|-1.01|1.07||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.07|-1.01|2.851
73855235|NCT04283994|147257214|SUPERIORITY||Mean Difference (Final Values)|-0.28||||1.243|TWO_SIDED|95.0|-0.97|0.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.40|-0.97|1.243
73855236|NCT04283994|147257214|SUPERIORITY||Mean Difference (Final Values)|-0.33||||1.032|TWO_SIDED|95.0|-1.0|0.35||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.35|-1.00|1.032
73855237|NCT04283994|147257214|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.742|TWO_SIDED|95.0|-0.7|0.78||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.78|-0.70|2.742
73855238|NCT04283994|147257215|SUPERIORITY||Mean Difference (Final Values)|-0.02||||2.658|TWO_SIDED|95.0|-0.26|0.22||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.22|-0.26|2.658
73855239|NCT04283994|147257215|SUPERIORITY||Mean Difference (Final Values)|0.07||||1.523|TWO_SIDED|95.0|-0.14|0.29||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.29|-0.14|1.523
73855240|NCT04283994|147257215|SUPERIORITY||Mean Difference (Final Values)|-0.09||||1.381|TWO_SIDED|95.0|-0.33|0.15||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.15|-0.33|1.381
73962946|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-17.8|STANDARD_ERROR_OF_MEAN|14.14||0.1051|TWO_SIDED|90.0|-41.2|5.6|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||5.6|-41.2|0.1051
73962947|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-37.8|STANDARD_ERROR_OF_MEAN|13.8||0.0034|TWO_SIDED|90.0|-60.6|-15.0|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.0|-60.6|0.0034
73962948|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-41.9|STANDARD_ERROR_OF_MEAN|13.83||0.0014|TWO_SIDED|90.0|-64.8|-19.0|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-19.0|-64.8|0.0014
73855241|NCT04283994|147257216|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.191|TWO_SIDED|95.0|-0.18|0.25||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.25|-0.18|2.191
73855242|NCT04283994|147257216|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.138|TWO_SIDED|95.0|-0.19|0.27||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.27|-0.19|2.138
73855243|NCT04283994|147257216|SUPERIORITY||Mean Difference (Final Values)|-0.01||||2.879|TWO_SIDED|95.0|-0.23|22.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||022|-0.23|2.879
73855244|NCT01331837|147257253|NON_INFERIORITY_OR_EQUIVALENCE|In order to reject the null hypothesis and claim non-inferiority of TCZ compared to ETA, a HR point estimate of ≤ 1.278 and upper limit of 95% CI \<1.8 was required.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.77|1.43||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.43|0.77|
73855245|NCT01331837|147257255|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.76|1.62||||||"The analysis assessed in the OT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.62|0.76|
73855246|NCT01331837|147257257|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.73|1.4||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.40|0.73|
73855247|NCT01331837|147257259|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.7|1.56||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.56|0.70|
73855248|NCT01331837|147257261|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.73|1.34||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.34|0.73|
73855249|NCT01331837|147257263|NON_INFERIORITY_OR_EQUIVALENCE|'The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.49||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.49|0.54|
73855250|NCT01331837|147257265|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.64|1.63||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.63|0.64|
73905220|NCT02788474|147341028|OTHER||Odds Ratio (OR)|0.772||||0.3175|TWO_SIDED|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the monthly rate of change (slope) in blood CRPM in the first 12 weeks could explain the effect of treatment on disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death), a logistic regression analysis including baseline blood CRPM, the rate of change (slope) in blood CRPM in the first 12 weeks and randomised treatment as covariates was applied.||1.27|0.46|0.3175
73930915|NCT00280566|147391707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.71||0.0758|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0758
74084991|NCT02339415|147723633|SUPERIORITY||Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|0.17||0.002|TWO_SIDED|95.0|-0.88|-0.2|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.|||-0.20|-0.88|0.002
73905221|NCT02788474|147341029|OTHER||Adjusted mean difference|0.00121|STANDARD_ERROR_OF_MEAN|0.002||0.5469|TWO_SIDED|95.0|-0.00273|0.00515||random coefficient regression model (C1M (negative reciprocal root-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.|"The rate of change (slope) in blood C1M was assumed to be linear in each subject over the 12 weeks of treatment.~Within-patient errors are modelled by an Unstructured variance-covariance matrix."||0.00515|-0.00273|0.5469
73905222|NCT02788474|147341030|OTHER||Adjusted mean difference|-0.00307|STANDARD_ERROR_OF_MEAN|0.00262||0.2429|TWO_SIDED|95.0|-0.00823|0.00209||random coefficient regression model (C3M (log10-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.|"The rate of change (slope) in blood C3M was assumed to be linear in each subject over the 12 weeks of treatment.~Within-patient errors are modelled by an Unstructured variance-covariance matrix."||0.00209|-0.00823|0.2429
73905223|NCT02536833|147341080|SUPERIORITY||Mean Difference (Final Values)|-1.46||||0.575|TWO_SIDED|95.0|-6.57|3.65|||ANCOVA|||||3.65|-6.57|0.575
73905224|NCT02536833|147341080|SUPERIORITY||Mean Difference (Final Values)|-1.27||||0.643|TWO_SIDED|95.0|-6.63|4.09|||ANCOVA|||||4.09|-6.63|0.643
73905225|NCT02536833|147341080|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.901|TWO_SIDED|95.0|-5.07|5.75|||ANCOVA|||||5.75|-5.07|0.901
73905226|NCT02536833|147341081|SUPERIORITY||Mean Difference (Final Values)|-2.99||||0.271|TWO_SIDED|95.0|-8.31|2.33|||ANCOVA|||||2.33|-8.31|0.271
73905227|NCT02536833|147341081|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.898|TWO_SIDED|95.0|-6.06|5.32|||ANCOVA|||||5.32|-6.06|0.898
73905228|NCT02536833|147341081|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.795|TWO_SIDED|95.0|-4.74|6.18|||ANCOVA|||||6.18|-4.74|0.795
73905229|NCT02536833|147341082|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.283|TWO_SIDED|95.0|-7.74|2.26|||ANCOVA|||||2.26|-7.74|0.283
73905230|NCT02536833|147341082|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.588|TWO_SIDED|95.0|-6.82|3.86|||ANCOVA|||||3.86|-6.82|0.588
73905231|NCT02536833|147341082|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.853|TWO_SIDED|95.0|-5.76|4.76|||ANCOVA|||||4.76|-5.76|0.853
73962949|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-38.6|STANDARD_ERROR_OF_MEAN|13.9||0.003|TWO_SIDED|90.0|-61.6|-15.6|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.6|-61.6|0.0030
74084992|NCT01765751|147723636|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|-0.1|5.6|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||5.6|-0.1|
73905232|NCT02536833|147341083|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.292|TWO_SIDED|95.0|-8.26|2.49|||ANCOVA|||||2.49|-8.26|0.292
73905233|NCT02536833|147341083|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.931|TWO_SIDED|95.0|-5.34|5.83|||ANCOVA|||||5.83|-5.34|0.931
73905234|NCT02536833|147341083|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.878|TWO_SIDED|95.0|-4.92|5.76|||ANCOVA|||||5.76|-4.92|0.878
73905235|NCT02536833|147341084|SUPERIORITY||Mean Difference (Final Values)|1.16||||0.648|TWO_SIDED|95.0|-3.83|6.16|||ANCOVA|||||6.16|-3.83|0.648
73905236|NCT02536833|147341084|SUPERIORITY||Mean Difference (Final Values)|-3.14||||0.209|TWO_SIDED|95.0|-8.02|1.75|||ANCOVA|||||1.75|-8.02|0.209
73905237|NCT02536833|147341084|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.915|TWO_SIDED|95.0|-4.78|5.33|||ANCOVA|||||5.33|-4.78|0.915
73962950|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-17.7|STANDARD_ERROR_OF_MEAN|9.22||0.0289|TWO_SIDED|90.0|-33.0|-2.4|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.||-2.4|-33.0|0.0289
74084993|NCT01765751|147723636|SUPERIORITY||Mean Difference (Final Values)|3.0|||||TWO_SIDED|95.0|0.1|5.9|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||5.9|0.1|
73905238|NCT02536833|147341085|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.969|TWO_SIDED|95.0|-5.16|5.36|||ANCOVA|||||5.36|-5.16|0.969
73905239|NCT02536833|147341085|SUPERIORITY||Mean Difference (Final Values)|-3.64||||0.174|TWO_SIDED|95.0|-8.89|1.61|||ANCOVA|||||1.61|-8.89|0.174
73905240|NCT02536833|147341085|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.908|TWO_SIDED|95.0|-4.97|5.59|||ANCOVA|||||5.59|-4.97|0.908
73905241|NCT02536833|147341086|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.334|TWO_SIDED|95.0|-0.1|0.29|||ANCOVA|||||0.29|-0.10|0.334
73905242|NCT02536833|147341086|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.124|TWO_SIDED|95.0|-0.04|0.3|||ANCOVA|||||0.30|-0.04|0.124
73905243|NCT02536833|147341086|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.032|TWO_SIDED|95.0|0.02|0.36|||ANCOVA|||||0.36|0.02|0.032
73905244|NCT02536833|147341087|SUPERIORITY||Mean Difference (Final Values)|-2.38||||0.405|TWO_SIDED|95.0|-8.0|3.24|||ANCOVA|||||3.24|-8.00|0.405
73905245|NCT02536833|147341087|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.552|TWO_SIDED|95.0|-4.37|8.16|||ANCOVA|||||8.16|-4.37|0.552
73905246|NCT02536833|147341087|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.763|TWO_SIDED|95.0|-4.91|6.68|||ANCOVA|||||6.68|-4.91|0.763
73905247|NCT02536833|147341088|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.173|TWO_SIDED|95.0|-9.5|1.71|||ANCOVA|||||1.71|-9.50|0.173
73905248|NCT02536833|147341088|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.724|TWO_SIDED|95.0|-5.12|7.36|||ANCOVA|||||7.36|-5.12|0.724
73905249|NCT02536833|147341088|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.914|TWO_SIDED|95.0|-6.17|5.53|||ANCOVA|||||5.53|-6.17|0.914
74025380|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 2 between the two arms"||||0.46
74025381|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean fatigue score from period 1 to period 2 between the two arms."|Difference in Change|-0.07||||0.58|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 2 between the two arms"||||0.58
74025382|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean cough score from period 1 to period 2 between the two arms."|Difference in Change|0.01||||0.92|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 2 between the two arms"||||0.92
74084994|NCT01765751|147723636|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-3.2|2.7|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||2.7|-3.2|
73855251|NCT01331837|147257267|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.53|||||TWO_SIDED|95.0|0.8|2.92||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||2.92|0.80|
73855252|NCT01331837|147257269|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.7|1.41||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.41|0.70|
73855253|NCT03724981|147257290|SUPERIORITY||||||<|0.0001|||||||Prescott test|||||||<0.0001
73855254|NCT03724981|147257291|SUPERIORITY||||||<|0.0001|||||||Prescott test|||||||<0.0001
73855255|NCT00678535|147257320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.3158||95.0|0.92|1.292|||Stratified log rank||Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|Primary efficacy analysis: To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, α=5%).||1.292|0.920|0.3158
73855256|NCT00678535|147257321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.004||||0.9547||95.0|0.866|1.165|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior (neo-) adjuvant(radio) chemotherapy, α=5%)||1.165|0.866|0.9547
73855257|NCT00678535|147257322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0435||||0.7696||95.0|0.7844|1.3882|||Cochran-Mantel-Haenszel|||The best overall response rate was compared with the Cochran-Mantel-Haenszel test (strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, two-sided with α=5%).||1.3882|0.7844|0.7696
73855258|NCT02578680|147257326|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|1e-05|TWO_SIDED|95.0|0.43|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.64|0.43|<0.00001
73855259|NCT02578680|147257327|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|1e-05|TWO_SIDED|95.0|0.38|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.64|0.38|<0.00001
73855260|NCT02578680|147257328|SUPERIORITY||Difference in Percentage vs. Control|28.5|||<|0.0001|TWO_SIDED|95.0|21.1|35.4||H0:Difference in percentages=0 vs H1:Difference in percentages\>0|Stratified Miettinen and Nurminen||Miettinen and Nurminen method with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||35.4|21.1|<0.0001
73855261|NCT02578680|147257332|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|1e-05|TWO_SIDED|95.0|0.41|0.59|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.59|0.41|<0.00001
73855262|NCT00734604|147257351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.04||0.001|TWO_SIDED|95.0|0.04|0.19||p-value is for difference in LS Means change from baseline between tadalafil OaD and Sildenafil PRN.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.19|0.04|0.001
74084995|NCT01765751|147723637|SUPERIORITY||Mean Difference (Final Values)|15.6|||||TWO_SIDED|95.0|1.6|29.7|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||29.7|1.6|
73855263|NCT00734604|147257352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.872|TWO_SIDED|95.0|-0.06|0.08||p-value is for difference in Pairs Sexual Self-Confidence Domain Score LS Mean and Change from Baseline between Tadalafil OaD and Tadalafil PRN Population|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|LS Mean difference = Tadalafil OaD-Tadalafil PRN|||0.08|-0.06|0.872
73855264|NCT00734604|147257353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.1|0.2||p-value is for difference between Tadalafil OaD and Sildenafil PRN change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.20|0.10|<0.001
73855265|NCT00734604|147257353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.395|TWO_SIDED|95.0|-0.03|0.07||p-value is for difference between Tadalafil OaD and Tadalafil PRN in change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.07|-0.03|0.395
73855266|NCT00734604|147257354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.36|-0.25||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.25|-0.36|<0.001
73855267|NCT00734604|147257354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.2|-0.08||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.08|-0.20|<0.001
73855268|NCT00734604|147257355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.3||0.004|TWO_SIDED|95.0|-1.43|-0.27||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.27|-1.43|0.004
73855269|NCT00734604|147257355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.29||0.007|TWO_SIDED|95.0|-1.37|-0.22||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.22|-1.37|0.007
73855270|NCT00734604|147257356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.03|0.09||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.09|0.03|<0.001
73855271|NCT00734604|147257356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.06|0.12||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.12|0.06|<0.001
73855272|NCT00734604|147257357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.91|-0.36||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.36|-0.91|<0.001
73855273|NCT00734604|147257357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.78|-0.23||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|||||-0.23|-0.78|<0.001
73855274|NCT00734604|147257358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.055|TWO_SIDED|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.00|-0.44|0.055
73855275|NCT00734604|147257358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.046|TWO_SIDED|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.00|-0.44|0.046
73855276|NCT00734604|147257359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.27||0.004|TWO_SIDED|95.0|1.16|6.17||p-value is for the difference between Tadalafil PRN and Sildenafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||6.17|1.16|0.004
73905250|NCT02536833|147341089|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.529|TWO_SIDED|95.0|-0.12|0.24|||ANCOVA|||||0.24|-0.12|0.529
73905251|NCT02536833|147341089|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.259|TWO_SIDED|95.0|-0.08|0.28|||ANCOVA|||||0.28|-0.08|0.259
73905252|NCT02536833|147341089|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.807|TWO_SIDED|95.0|-0.21|0.16|||ANCOVA|||||0.16|-0.21|0.807
73905253|NCT02536833|147341090|SUPERIORITY||Mean Difference (Final Values)|-8.73||||0.049|TWO_SIDED|95.0|-17.44|-0.03|||ANCOVA|||||-0.03|-17.44|0.049
73905254|NCT02536833|147341090|SUPERIORITY||Mean Difference (Final Values)|-6.03||||0.211|TWO_SIDED|95.0|-15.49|3.43|||ANCOVA|||||3.43|-15.49|0.211
73905255|NCT02536833|147341090|SUPERIORITY||Mean Difference (Final Values)|-5.23||||0.254|TWO_SIDED|95.0|-14.24|3.78|||ANCOVA|||||3.78|-14.24|0.254
73905256|NCT02536833|147341091|SUPERIORITY||Mean Difference (Final Values)|-10.26||||0.036|TWO_SIDED|95.0|-19.82|-0.69|||ANCOVA|||||-0.69|-19.82|0.036
73905257|NCT02536833|147341091|SUPERIORITY||Mean Difference (Final Values)|-7.07||||0.17|TWO_SIDED|95.0|-17.18|3.05|||ANCOVA|||||3.05|-17.18|0.170
73905258|NCT02536833|147341091|SUPERIORITY||Mean Difference (Final Values)|-6.29||||0.171|TWO_SIDED|95.0|-15.33|2.74|||ANCOVA|||||2.74|-15.33|0.171
73905259|NCT02536833|147341092|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.021|TWO_SIDED|95.0|0.06|0.72|||ANCOVA|||||0.72|0.06|0.021
73905260|NCT02536833|147341092|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.131|TWO_SIDED|95.0|-0.07|0.55|||ANCOVA|||||0.55|-0.07|0.131
73905261|NCT02536833|147341092|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.789|TWO_SIDED|95.0|-0.35|0.26|||ANCOVA|||||0.26|-0.35|0.789
73905262|NCT02140775|147341148|SUPERIORITY|||||||0.602|||||||Chi-squared|degrees of freedom = 1||A Chi-Square test was conducted between the treatment groups and the dichotomous outcome of successful achievement of employment goal.||||.602
73905263|NCT02140775|147341149|SUPERIORITY||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|2.0||0.066|TWO_SIDED|95.0|-7.75|0.26|||t-test, 2 sided|||||0.26|-7.75|.066
74025383|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean urination score from period 1 to period 2 between the two arms."|Difference in Change|0.02||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 2 between the two arms"||||0.84
73905264|NCT02140775|147341150|SUPERIORITY||Mean Difference (Final Values)|-3.25|STANDARD_ERROR_OF_MEAN|7.68||0.674|TWO_SIDED|95.0|-18.59|12.09|||t-test, 2 sided|||||12.09|-18.59|.674
73905265|NCT05308290|147341168|OTHER|||||||0.6||||||the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.60
74025384|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean clumsy score from period 1 to period 2 between the two arms."|Difference in Change|0.03||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 2 between the two arms"||||0.83
74025385|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean fever score from period 1 to period 2 between the two arms."|Difference in Change|0.04||||0.72|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 2 between the two arms"||||0.72
74025386|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 2 between the two arms."|Difference in Change|0.06||||0.48|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 2 between the two arms"||||0.48
73855277|NCT00734604|147257359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|1.27||0.006|TWO_SIDED|95.0|-6.05|-1.04||p-value is for the difference between Tadalafil OaD and Tadalafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-1.04|-6.05|0.006
73855278|NCT00734604|147257361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|1.05||0.915|TWO_SIDED|95.0|-1.95|2.17||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||2.17|-1.95|0.915
73855279|NCT00734604|147257361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.04||0.212|TWO_SIDED|95.0|-3.35|0.74||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.74|-3.35|0.212
73855280|NCT00734604|147257362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.403|TWO_SIDED|95.0|-0.09|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.22|-0.09|0.403
73855281|NCT00734604|147257362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.367|TWO_SIDED|95.0|-0.08|0.23||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.23|-0.08|0.367
73855282|NCT00734604|147257363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.06||0.002|TWO_SIDED|95.0|0.07|0.32||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.32|0.07|0.002
73905266|NCT05308290|147341169|OTHER|||||||0.6||||||the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.60
73905267|NCT05308290|147341170|OTHER|||||||1||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||1.0
73905268|NCT05308290|147341171|OTHER|||||||1||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||1.0
73855283|NCT00734604|147257363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.722|TWO_SIDED|95.0|-0.15|0.1||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.10|-0.15|0.722
73855284|NCT00734604|147257364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.65|-0.37||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||-0.37|-0.65|<0.001
73855285|NCT00734604|147257364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.16||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||-0.16|-0.43|<0.001
73855286|NCT00734604|147257365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.07|TWO_SIDED|95.0|-0.01|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.22|-0.01|0.070
73905269|NCT05308290|147341172|OTHER|||||||0.28||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||0.28
73905270|NCT04437368|147341179|SUPERIORITY||LS Mean Difference|0.291|STANDARD_ERROR_OF_MEAN|0.2838|||TWO_SIDED|90.0|-0.195|0.777|||mixed model repeated measures|||Week 12||0.777|-0.195|
73905271|NCT04437368|147341179|SUPERIORITY||LS Mean Difference|0.282|STANDARD_ERROR_OF_MEAN|0.2843|||TWO_SIDED|90.0|-0.206|0.769|||mixed model repeated measures|||Week 12||0.769|-0.206|
73905272|NCT04437368|147341179|SUPERIORITY||LS Mean Difference|0.658|STANDARD_ERROR_OF_MEAN|0.373|||TWO_SIDED|90.0|0.017|1.299|||mixed model repeated measures|||Week 24||1.299|0.017|
73905273|NCT04437368|147341179|SUPERIORITY||LS Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.3791|||TWO_SIDED|90.0|0.189|1.49|||mixed model repeated measures|||Week 24||1.490|0.189|
73905274|NCT04437368|147341179|SUPERIORITY||LS Mean Difference|0.668|STANDARD_ERROR_OF_MEAN|0.4954|||TWO_SIDED|90.0|-0.177|1.512|||mixed model repeated measures|||Week 36||1.512|-0.177|
73905275|NCT04437368|147341179|SUPERIORITY||LS Mean Difference|0.912|STANDARD_ERROR_OF_MEAN|0.4887|||TWO_SIDED|90.0|0.078|1.746|||mixed model repeated measures|||Week 36||1.746|0.078|
73962951|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-33.8|STANDARD_ERROR_OF_MEAN|9.27||0.0002|TWO_SIDED|90.0|-49.2|-18.4|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-18.4|-49.2|0.0002
73962952|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-0.9|STANDARD_ERROR_OF_MEAN|13.88||0.4739|TWO_SIDED|90.0|-23.9|22.0|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||22.0|-23.9|0.4739
73962953|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-19.1|STANDARD_ERROR_OF_MEAN|13.43||0.0789|TWO_SIDED|90.0|-41.3|3.2|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||3.2|-41.3|0.0789
73962954|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-13.4|STANDARD_ERROR_OF_MEAN|13.5||0.1611|TWO_SIDED|90.0|-35.7|8.9|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||8.9|-35.7|0.1611
73962955|NCT03903822|147461909|SUPERIORITY||LS Mean Difference|-31.6|STANDARD_ERROR_OF_MEAN|13.94||0.0124|TWO_SIDED|90.0|-54.7|-8.5|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-8.5|-54.7|0.0124
73962956|NCT03903822|147461909|SUPERIORITY||LS Mean difference|-5.3|STANDARD_ERROR_OF_MEAN|17.68||0.3828|TWO_SIDED|90.0|-34.7|24.1|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||24.1|-34.7|0.3828
73905276|NCT04437368|147341179|SUPERIORITY||LS Mean Difference|0.976|STANDARD_ERROR_OF_MEAN|0.4813|||TWO_SIDED|90.0|0.15|1.803|||mixed model repeated measures|||Week 48||1.803|0.150|
73962957|NCT03903822|147461909|SUPERIORITY||LS Mean difference|1.7|STANDARD_ERROR_OF_MEAN|17.8||0.5383|TWO_SIDED|90.0|-27.9|31.3|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||31.3|-27.9|0.5383
73962958|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|-5.4||||0.8964|TWO_SIDED|90.0|-16.1|2.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||2.0|-16.1|0.8964
73962959|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|14.0||||0.0391|TWO_SIDED|90.0|1.0|28.2|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||28.2|1.0|0.0391
73962960|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-10.8|10.8|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||10.8|-10.8|1.0000
73962961|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|11.3||||0.0708|TWO_SIDED|90.0|-1.4|25.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||25.0|-1.4|0.0708
73962962|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|13.9||||0.0122|TWO_SIDED|90.0|4.7|27.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||27.0|4.7|0.0122
73962963|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|21.6||||0.0016|TWO_SIDED|90.0|11.0|35.6|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||35.6|11.0|0.0016
73962964|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|2.7||||0.395|TWO_SIDED|90.0|-9.8|16.1|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||16.1|-9.8|0.3950
73962965|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|19.7||||0.0173|TWO_SIDED|90.0|4.2|35.6|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||35.6|4.2|0.0173
73962966|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|16.2||||0.0327|TWO_SIDED|90.0|1.4|31.0|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||31.0|1.4|0.0327
73962967|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|30.8||||0.0011|TWO_SIDED|90.0|13.2|46.6|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||46.6|13.2|0.0011
73962968|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|11.1||||0.1348|TWO_SIDED|90.0|-5.0|27.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||27.2|-5.0|0.1348
73962969|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|18.5||||0.0328|TWO_SIDED|90.0|1.5|34.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||34.8|1.5|0.0328
73962970|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|10.8||||0.0769|TWO_SIDED|90.0|-1.8|24.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||24.4|-1.8|0.0769
73962971|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|30.7||||0.0005|TWO_SIDED|90.0|13.2|46.0|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||46.0|13.2|0.0005
73962972|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|37.8|||<|0.0001|TWO_SIDED|90.0|22.1|53.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||53.1|22.1|<0.0001
73962973|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|36.3||||0.0001|TWO_SIDED|90.0|19.7|51.8|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||51.8|19.7|0.0001
73962974|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-16.5|16.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||16.5|-16.5|1.0000
73962975|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|23.8||||0.0173|TWO_SIDED|90.0|4.5|41.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||41.5|4.5|0.0173
73905277|NCT04437368|147341179|SUPERIORITY||LS Mean Difference|1.233|STANDARD_ERROR_OF_MEAN|0.4573|||TWO_SIDED|90.0|0.445|2.022|||mixed model repeated measures|||Week 48||2.022|0.445|
73905278|NCT04437368|147341180|SUPERIORITY||LS Mean Difference|1.769|STANDARD_ERROR_OF_MEAN|1.2808|||TWO_SIDED|90.0|-0.441|3.979|||mixed model repeated measures|||Week 72||3.979|-0.441|
73905279|NCT04437368|147341180|SUPERIORITY||LS Mean Difference|1.274|STANDARD_ERROR_OF_MEAN|1.2349|||TWO_SIDED|90.0|-0.863|3.412|||mixed model repeated measures|||Week 72||3.412|-0.863|
73962976|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5663|TWO_SIDED|90.0|-19.9|14.2|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||14.2|-19.9|0.5663
73962977|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|14.6||||0.1243|TWO_SIDED|90.0|-3.8|32.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||32.6|-3.8|0.1243
73962978|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|18.9||||0.046|TWO_SIDED|90.0|-0.5|36.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||36.6|-0.5|0.0460
73962979|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|25.7||||0.013|TWO_SIDED|90.0|4.8|43.3|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||43.3|4.8|0.0130
73962980|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|13.9||||0.1194|TWO_SIDED|90.0|-4.2|31.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||31.4|-4.2|0.1194
73962981|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|26.4||||0.0097|TWO_SIDED|90.0|6.5|44.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||44.4|6.5|0.0097
74025387|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean dizziness score from period 1 to period 2 between the two arms."|Difference in Change|0.08||||0.54|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 2 between the two arms"||||0.54
74025388|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 2 between the two arms."|Difference in Change|0.09||||0.56|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 2 between the two arms"||||0.56
74084996|NCT01765751|147723637|SUPERIORITY||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|-3.7|23.3|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||23.3|-3.7|
73905280|NCT04437368|147341180|SUPERIORITY||LS Mean Difference|2.041|STANDARD_ERROR_OF_MEAN|1.4177|||TWO_SIDED|90.0|-0.386|4.468|||mixed model repeated measures|||Week 96||4.468|-0.386|
73905281|NCT04437368|147341180|SUPERIORITY||LS Mean|1.278|STANDARD_ERROR_OF_MEAN|1.3857|||TWO_SIDED|90.0|-1.099|3.655|||mixed model repeated measures|||Week 96||3.655|-1.099|
73905282|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.49|||TWO_SIDED|90.0|-10.3|8.1|||mixed model repeated measures|||Week 12||8.1|-10.3|
73905283|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|5.96|||TWO_SIDED|90.0|-16.3|3.7|||mixed model repeated measures|||Week 12||3.7|-16.3|
73962982|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5556|TWO_SIDED|90.0|-21.0|16.1|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||16.1|-21.0|0.5556
73962983|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|17.6||||0.0761|TWO_SIDED|90.0|-2.5|36.5|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||36.5|-2.5|0.0761
73962984|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|18.9||||0.0583|TWO_SIDED|90.0|-0.8|37.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||37.6|-0.8|0.0583
73962985|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|14.9||||0.1245|TWO_SIDED|90.0|-5.0|33.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||33.7|-5.0|0.1245
73962986|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|19.4||||0.0382|TWO_SIDED|90.0|1.5|36.5|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||36.5|1.5|0.0382
73962987|NCT03903822|147461910|SUPERIORITY||Risk Difference (RD)|34.7||||0.0011|TWO_SIDED|90.0|13.2|51.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||51.4|13.2|0.0011
73905284|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|5.54|||TWO_SIDED|90.0|-14.5|4.1|||mixed model repeated measures|||Week 24||4.1|-14.5|
73905285|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|-11.7|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|90.0|-21.7|-1.6|||mixed model repeated measures|||Week 24||-1.6|-21.7|
73962988|NCT01796236|147461931|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mantel Haenszel|||||||0.12
73962989|NCT01796236|147461932|SUPERIORITY_OR_OTHER|||||||0.45|||||||Mantel Haenszel|||"Combined Endpoint is calculated as the sum of the following four events from 3 weeks to 3 years:~Holgers Index \>=2. Any Overgrowth \>=2. Pain (scar/neuropathic) \>=3. Any numbness \>=2.~Each event is counted only once"||||0.45
73962990|NCT01796236|147461933|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mann-Whitney U test|||||||<0.0001
73962991|NCT01796236|147461934|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||Day 10||||0.020
73962992|NCT01796236|147461934|SUPERIORITY_OR_OTHER|||||||0.4|||||||Fisher Exact|||Week 3||||0.4
73962993|NCT01796236|147461934|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Week 6||||1.00
73962994|NCT01796236|147461934|SUPERIORITY_OR_OTHER|||||||0.97|||||||Fisher Exact|||Week 12||||0.97
73962995|NCT01796236|147461934|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Week 24||||1.00
73962996|NCT01796236|147461935|SUPERIORITY_OR_OTHER|||||||0.4|||||||Mantel Haenszel|||Maximum of Holgers at 12 Months||||0.40
73962997|NCT01796236|147461935|SUPERIORITY_OR_OTHER|||||||0.14|||||||Mantel Haenszel|||Maximum of Holgers at 36 Months||||0.14
73962998|NCT01796236|147461936|SUPERIORITY_OR_OTHER|||||||0.38|||||||Mantel Haenszel|||Holgers Index Day 10||||0.38
73962999|NCT01796236|147461936|SUPERIORITY_OR_OTHER|||||||0.17|||||||Mantel Haenszel|||Holgers Index Week 3||||0.17
74025389|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 2 between the two arms."|Difference in Change|0.1||||0.22|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 2 between the two arms"||||0.22
74025390|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 2 between the two arms."|Difference in Change|0.11||||0.4|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 2 between the two arms"||||0.40
73905286|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|5.63|||TWO_SIDED|90.0|-18.4|0.5|||mixed model repeated measures|||Week 36||0.5|-18.4|
73905287|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|90.0|-22.1|-1.7|||mixed model repeated measures|||Week 36||-1.7|-22.1|
73905288|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|90.0|-12.7|6.9|||mixed model repeated measures|||Week 48||6.9|-12.7|
73905289|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|6.14|||TWO_SIDED|90.0|-17.9|2.7|||mixed model repeated measures|||Week 48||2.7|-17.9|
73963000|NCT01796236|147461936|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mantel Haenszel|||Holgers Index Week 6||||0.37
73963001|NCT01796236|147461936|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mantel Haenszel|||Holgers Index Week 12||||0.73
73963002|NCT01796236|147461936|SUPERIORITY_OR_OTHER|||||||0.47|||||||Mantel Haenszel|||Holgers Index Week 24||||0.47
73963003|NCT01796236|147461936|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mantel Haenszel|||Holgers Index Month 12||||0.73
74025391|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean anxiety score from period 1 to period 2 between the two arms."|Difference in Change|0.13||||0.35|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 2 between the two arms"||||0.35
74025392|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 2 between the two arms."|Difference in Change|0.17||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 2 between the two arms"||||0.11
73905290|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|5.96|||TWO_SIDED|90.0|-7.4|12.5|||mixed model repeated measures|||Week 72||12.5|-7.4|
73963004|NCT01796236|147461936|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mantel Haenszel|||Holgers Index Month 24||||0.37
73963005|NCT01796236|147461936|SUPERIORITY_OR_OTHER|||||||0.75|||||||Mantel Haenszel|||Holgers Index Month 36||||0.75
73963006|NCT01796236|147461937|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 12 months||||<0.0001
73963007|NCT01796236|147461937|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 36 months||||<0.0001
73963008|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Day 10, Neuropathic pain||||0.74
73905291|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|6.18|||TWO_SIDED|90.0|-11.1|9.6|||mixed model repeated measures|||Week 72||9.6|-11.1|
73905292|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|90.0|-8.7|11.5|||mixed model repeated measures|||Week 96||11.5|-8.7|
73905293|NCT04437368|147341186|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|6.47|||TWO_SIDED|90.0|-13.8|7.8|||mixed model repeated measures|||Week 96||7.8|-13.8|
73963009|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Day 10, Scar pain||||0.36
73963010|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Week 3, Neuropathic pain||||0.030
73963011|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Week 3, Scar pain||||0.92
73963012|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Week 6, Neuropathic pain||||0.15
73963013|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Week 6, Scar pain||||0.38
73963014|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Week 12, Neuropathic pain||||0.015
73963015|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12, Scar pain||||0.72
73963016|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Week 24, Neuropathic pain||||0.44
73963017|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24, Scar pain||||0.43
73963018|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12, Neuropathic pain||||0.21
73963019|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12, Scar pain||||0.97
73963020|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36, Neuropathic pain||||0.19
73963021|NCT01796236|147461938|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Month 36, Scar pain||||0.77
73963022|NCT01796236|147461939|SUPERIORITY_OR_OTHER|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain||||0.076
73963023|NCT01796236|147461939|SUPERIORITY_OR_OTHER|||||||0.49|||||||Mantel Haenszel|||Scar Categorical Max Pain||||0.49
73963024|NCT01796236|147461940|SUPERIORITY_OR_OTHER|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain 36 months||||0.076
74084997|NCT01765751|147723637|SUPERIORITY||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-8.6|20.3|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||20.3|-8.6|
73855287|NCT00734604|147257365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.637|TWO_SIDED|95.0|-0.14|0.09||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.09|-0.14|0.637
73855288|NCT02589665|147257366|SUPERIORITY||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|0.7|12.27||||||||12.27|0.70|
73855289|NCT02589665|147257366|SUPERIORITY||Odds Ratio (OR)|7.22|||||TWO_SIDED|95.0|1.88|27.65||||||||27.65|1.88|
73855290|NCT02589665|147257366|SUPERIORITY||Odds Ratio (OR)|3.61|||||TWO_SIDED|95.0|0.92|14.17||||||||14.17|0.92|
73855291|NCT02589665|147257367|SUPERIORITY||Odds Ratio (OR)|3.95|||||TWO_SIDED|95.0|1.73|8.98||||||||8.98|1.73|
73855292|NCT02589665|147257367|SUPERIORITY||Odds Ratio (OR)|6.78|||||TWO_SIDED|95.0|2.94|15.63||||||||15.63|2.94|
73905294|NCT04105543|147341255|OTHER|nonparametric rank test|Median Difference (Final Values)|-4.22||||0.173|TWO_SIDED|95.0|-12.64|4.24|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for MDADI Composite Baseline to 3 months (n=9)||4.24|-12.64|0.173
73905295|NCT04105543|147341255|OTHER|nonparametric rank test|Median Difference (Final Values)|-9.998||||0.225|TWO_SIDED|95.0|-28.43|7.39|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for MDADI Composite Baseline to 6 months (n=5)||7.39|-28.43|0.225
73905296|NCT04105543|147341256|OTHER|nonparametric rank test|Median Difference (Final Values)|-0.037||||0.779|TWO_SIDED|95.0|-0.246|0.09|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for Stimulated Saliva Flow Baseline to 3 months (n=8)||0.09|-0.246|0.779
73905297|NCT04105543|147341256|OTHER|nonparametric rank test|Median Difference (Final Values)|-0.049||||0.465|TWO_SIDED|95.0|-0.218|0.12|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for Stimulated Saliva Flow Baseline to 6 months (n=4)||0.12|-0.218|0.465
73905298|NCT04105543|147341257|OTHER|nonparametric rank test|Median Difference (Final Values)|-4.444||||0.213|TWO_SIDED|95.0|-14.4|4.4|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Functional Score Baseline to 3 months (n=9)||4.4|-14.4|0.213
73905299|NCT04105543|147341257|OTHER|nonparametric rank test|Median Difference (Final Values)|-6.667||||0.686|TWO_SIDED|95.0|-17.8|20.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Functional Scores Baseline to 6 months (n=5)||20|-17.8|0.686
73905300|NCT04105543|147341257|OTHER|nonparametric rank test|Median Difference (Final Values)|3.846||||0.498|TWO_SIDED|95.0|-0.769|12.82|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Symptom Score Baseline to 3 months (n=9)||12.82|-0.769|0.498
73963025|NCT01796236|147461940|SUPERIORITY_OR_OTHER|||||||0.71|||||||Mantel Haenszel|||Scar Categorical Max Pain 36 months||||0.71
73855293|NCT02589665|147257367|SUPERIORITY||Odds Ratio (OR)|2.78|||||TWO_SIDED|95.0|1.23|6.29||||||||6.29|1.23|
73855294|NCT02589665|147257368|SUPERIORITY|||||||0.986|||||||Mantel Haenszel|||||||0.986
73855295|NCT02589665|147257368|SUPERIORITY|||||||0.553|||||||Mantel Haenszel|||||||0.553
73855296|NCT02589665|147257368|SUPERIORITY|||||||0.56|||||||Mantel Haenszel|||||||0.560
73855297|NCT02589665|147257369|SUPERIORITY||Odds Ratio (OR)|2.29|||||TWO_SIDED|95.0|0.8|6.55||||||||6.55|0.80|
73855298|NCT02589665|147257370|SUPERIORITY||Mean Difference (Final Values)|22.9|||||TWO_SIDED|95.0|11.0|34.9||||||||34.9|11.0|
73855299|NCT02589665|147257370|SUPERIORITY||Mean Difference (Final Values)|20.5|||||TWO_SIDED|95.0|8.7|32.3||||||||32.3|8.7|
73855300|NCT02589665|147257370|SUPERIORITY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-1.0|22.5||||||||22.5|-1.0|
73855301|NCT02589665|147257372|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.39|-0.41||||||||-0.41|-1.39|
73855302|NCT02589665|147257372|SUPERIORITY||Mean Difference (Final Values)|-1.06|||||TWO_SIDED|95.0|-1.54|-0.59||||||||-0.59|-1.54|
73855303|NCT02589665|147257372|SUPERIORITY||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-1.07|-0.11||||||||-0.11|-1.07|
73855304|NCT02589665|147257375|SUPERIORITY||Odds Ratio (OR)|3.61||||0.003|TWO_SIDED|95.0|1.57|8.31|||Regression, Logistic|||||8.31|1.57|0.003
73855305|NCT02589665|147257375|SUPERIORITY||Odds Ratio (OR)|6.54|||<|0.001|TWO_SIDED|95.0|2.81|15.2|||Regression, Logistic|||||15.20|2.81|<0.001
73855306|NCT02589665|147257375|SUPERIORITY||Odds Ratio (OR)|2.27||||0.054|TWO_SIDED|95.0|0.98|5.22|||Regression, Logistic|||||5.22|0.98|0.054
73855307|NCT02589665|147257376|SUPERIORITY||Odds Ratio (OR)|0.48||||0.131|TWO_SIDED|95.0|0.19|1.24|||Regression, Logistic|||||1.24|0.19|0.131
73855308|NCT02589665|147257377|SUPERIORITY||Odds Ratio (OR)|2.25||||0.215|TWO_SIDED|95.0|0.63|8.07|||Regression, Logistic|||||8.07|0.63|0.215
73855309|NCT02589665|147257377|SUPERIORITY||Odds Ratio (OR)|7.7|||<|0.001|TWO_SIDED|95.0|2.37|25.0|||Regression, Logistic|||||25.00|2.37|<0.001
73855310|NCT02589665|147257377|SUPERIORITY||Odds Ratio (OR)|4.62||||0.012|TWO_SIDED|95.0|1.41|15.14|||Regression, Logistic|||||15.14|1.41|0.012
73855311|NCT02589665|147257378|SUPERIORITY||Odds Ratio (OR)|0.71||||0.428|TWO_SIDED|95.0|0.31|1.65|||Regression, Logistic|||||1.65|0.31|0.428
73855312|NCT04478071|147257407|SUPERIORITY||Risk Difference (RD)|-0.036|||||TWO_SIDED|95.0|-0.084|0.009|||||"Risk difference of Vadadustat relative to Placebo. Values under confidence interval reflect Bayesian 95% credible interval rather than frequentist confidence interval."|Trial used Bayesian analysis for superiority. Hypothesis Testing for Primary Outcome: Among adult hospital admissions with lab-confirmed diagnosis of COVID-19, vadadustat 900 mg will demonstrate superiority to placebo as defined by a lower probability, at treatment day 14, of death (8) or hospitalization, on invasive mechanical ventilation or ECMO (7) or hospitalization, on non-invasive ventilation or high flow oxygen devices (6) on the NIAID-OS. See Statistical Analysis Plan for more details.||0.009|-0.084|
73855313|NCT04478071|147257407|SUPERIORITY||Posterior Probability|0.94|||||TWO_SIDED||||||||Posterior probability of the risk difference of Vadadustat relative to Placebo.|||||
73905301|NCT04105543|147341257|OTHER|nonparametric rank test|Median Difference (Final Values)|10.256||||0.416|TWO_SIDED|95.0|-15.39|35.89|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Symptom Scores Baseline to 6 months (n=5)||35.89|-15.39|0.416
73963026|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.52|||||||Cochran-Mantel-Haenszel|||Day 10: Neuropathic pain||||0.52
73963027|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|||Day 10: Scar pain||||0.44
73963028|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.14|||||||Cochran-Mantel-Haenszel|||Week 3: Neuropathic pain||||0.14
73855314|NCT04478071|147257408|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.92|1.1|||||"Risk ratio of Vadadustat relative to Placebo. Values under confidence interval reflect Bayesian 95% credible interval rather than frequentist confidence interval."|Trial used Bayesian analysis for superiority. Hypothesis Testing for Secondary Outcome: Among adult hospital admissions with lab-confirmed diagnosis of COVID-19, vadadustat 900 mg will demonstrate superiority to placebo as defined by a higher probability, at treatment day 14, of recovery on the MSOFA scale (MSOFA = 0).||1.1|0.92|
73855315|NCT04478071|147257408|SUPERIORITY||Posterior probability|0.57|||||TWO_SIDED||||||||Posterior probability of the risk ratio of Vadadustat relative to Placebo.|||||
73855316|NCT06053541|147257420|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.24
73855317|NCT06053541|147257421|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.37
73855318|NCT06053541|147257422|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.03
73905302|NCT04105543|147341257|OTHER|nonparametric rank test|Median Difference (Final Values)|-8.33||||0.778|TWO_SIDED|95.0|-20.84|16.67|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Global Health Status Score Baseline to 3 months (n=9)||16.67|-20.84|0.778
73905303|NCT04105543|147341257|OTHER|nonparametric rank test|Median Difference (Final Values)|0.0||||0.89|TWO_SIDED|95.0|-25.0|25.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Global Health Status Scores Baseline to 6 months (n=5)||25|-25|0.89
73905304|NCT04105543|147341258|OTHER|nonparametric rank test|Median Difference (Final Values)|3.5||||0.138|TWO_SIDED|95.0|-2.0|9.5|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for XeQOL Baseline to 3 months (n=9)||9.5|-2|0.138
73905305|NCT04105543|147341258|OTHER|nonparametric rank test|Median Difference (Final Values)|6.0||||0.225|TWO_SIDED|95.0|-10.0|16.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for XeQOL Baseline to 6 months (n=5)||16|-10|0.225
73905306|NCT04105543|147341259|OTHER|nonparametric rank test|Median Difference (Final Values)|0.5||||0.674|TWO_SIDED|95.0|-3.0|5.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for Xerostomia Inventory Baseline to 3 months (n=9)||5|-3|0.674
73905307|NCT04105543|147341259|OTHER|nonparametric rank test|Median Difference (Final Values)|0.0||||0.892|TWO_SIDED|95.0|-6.0|6.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for Xerostomia Inventory Baseline to 6 months (n=5)||6|-6|0.892
73905308|NCT02393690|147341286|SUPERIORITY|||||||0.0787|||||||Fisher Exact|||||||0.0787
73905309|NCT02393690|147341287|SUPERIORITY|||||||0.0787|||||||Fisher Exact|||||||0.0787
73905310|NCT02393690|147341288|SUPERIORITY|||||||0.1764|||||||Log Rank|||||||0.1764
73905311|NCT02393690|147341289|SUPERIORITY|||||||0.0756|||||||Wilcoxon (Mann-Whitney)|||||||0.0756
73905312|NCT02567552|147341309|OTHER|||||||0.3395|||||||Chi-squared|||||||0.3395
73905313|NCT02567552|147341310|OTHER|||||||0.1523|||||||Chi-squared|||||||0.1523
73855319|NCT06053541|147257423|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Beds in the general practice and Pulmonology: For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.11
73855320|NCT06053541|147257423|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Beds in Adults ICU: For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||<0.01
73855321|NCT06053541|147257424|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.01
73855322|NCT06053541|147257425|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.07
73855323|NCT00245050|147257426|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||<|0.05|TWO_SIDED|95.0|0.536|2.16|||Chi-squared|||Based on published literature, it is estimated that the incidence of HFS for all grades is 49%. A decrease of 50% or more in the incidence of HFS in patients receiving pyridoxine would be of clinical significance. A sample size of 27 patients per group was chosen as this would allow us to detect a difference between HFS incidence of 49% and 11.5% (alpha=0.05, two-sided, power=0.80). Interim analysis was conducted after 30 patients were enrolled and had evaluable HFS assessment data.||2.16|0.536|<0.05
73905314|NCT02567552|147341311|OTHER|||||||0.1189|||||||t-test, 2 sided|||comparison between groups||||0.1189
73905315|NCT02567552|147341313|OTHER|||||||0.2042|||||||t-test, 2 sided|||||||0.2042
73905316|NCT02567552|147341314|OTHER|||||||0.6262|||||||t-test, 2 sided|||||||0.6262
73905317|NCT02567552|147341315|OTHER|||||||0.2301|||||||t-test, 2 sided|||||||0.2301
73905318|NCT02567552|147341316|OTHER|||||||0.5118|||||||t-test, 2 sided|||||||0.5118
73905319|NCT02567552|147341317|OTHER|||||||0.8371|||||||t-test, 2 sided|||||||0.8371
73905320|NCT02567552|147341318|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73905321|NCT02567552|147341319|OTHER|||||||0.3107|||||||t-test, 2 sided|||||||0.3107
73905322|NCT02567552|147341320|OTHER|||||||0.5|||||||Fisher Exact|||||||0.5
73905323|NCT01074047|147341322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0829|TWO_SIDED|95.0|0.69|1.02|||Log Rank|The p-value is two-sided from an unstratified log-rank test|The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.|||1.02|0.69|0.0829
73905324|NCT01074047|147341322|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1009|TWO_SIDED|95.0|0.69|1.03|||Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.|||1.03|0.69|0.1009
74084998|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-8.1|0.4|||||Pain Interference - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||0.4|-8.1|
73963029|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.59|||||||Cochran-Mantel-Haenszel|||Week 3: Scar pain||||0.59
73963030|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.17|||||||Cochran-Mantel-Haenszel|||Week 6: Neuropathic pain||||0.17
73963031|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|||Week 6: Scar pain||||0.44
73963032|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.0087|||||||Cochran-Mantel-Haenszel|||Week 12: Neuropathic pain||||0.0087
73963033|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.84|||||||Cochran-Mantel-Haenszel|||Week 12: Scar pain||||0.84
73963034|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.43|||||||Cochran-Mantel-Haenszel|||Week 24: Neuropathic pain||||0.43
73963035|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.33|||||||Cochran-Mantel-Haenszel|||Week 24: Scar pain||||0.33
73963036|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.21|||||||Cochran-Mantel-Haenszel|||Month 12 Neuropathic pain||||0.21
73963037|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.82|||||||Cochran-Mantel-Haenszel|||Month 12 Scar pain||||0.82
73963038|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.19|||||||Cochran-Mantel-Haenszel|||Month 36 Neuropathic pain||||0.19
73963039|NCT01796236|147461941|SUPERIORITY_OR_OTHER|||||||0.77|||||||Cochran-Mantel-Haenszel|||Month 36 Scar pain||||0.77
73963040|NCT01796236|147461942|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mantel Haenszel|||Day 10 Soft tissue thickening/overgrowth||||0.12
73963041|NCT01796236|147461942|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mantel Haenszel|||Week 3 Soft tissue thickening/overgrowth||||0.016
73855324|NCT00245050|147257427|SUPERIORITY_OR_OTHER|||||||0.916||95.0|||||t-test, 2 sided|||||||0.916
73963042|NCT01796236|147461942|SUPERIORITY_OR_OTHER|||||||0.84|||||||Mantel Haenszel|||Week 6 Soft tissue thickening/overgrowth||||0.84
73963043|NCT01796236|147461942|SUPERIORITY_OR_OTHER|||||||0.53|||||||Mantel Haenszel|||Week 12 Soft tissue thickening/overgrowth||||0.53
73963044|NCT01796236|147461942|SUPERIORITY_OR_OTHER|||||||0.18|||||||Mantel Haenszel|||Week 24 Soft tissue thickening/overgrowth||||0.18
73963045|NCT01796236|147461942|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mantel Haenszel|||Month 12 Soft tissue thickening/overgrowth||||0.63
73963046|NCT01796236|147461942|SUPERIORITY_OR_OTHER|||||||0.81|||||||Mantel Haenszel|||Month 24 Soft tissue thickening/overgrowth||||0.81
73963047|NCT01796236|147461942|SUPERIORITY_OR_OTHER|||||||1|||||||Mantel Haenszel|||Month 36 Soft tissue thickening/overgrowth||||1.00
73963048|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Day 10||||0.0009
73963049|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 3||||0.0080
73963050|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 6||||0.46
73963051|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 12||||0.45
73963052|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 24||||0.18
73963053|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 12||||0.017
73963054|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 24||||0.15
73963055|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 36||||0.32
73963056|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.74|||||||Sign test|||Change in Visible Test Abutment - Week 3 change from day 10||||0.74
73963057|NCT01796236|147461943|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Visible Test Abutment - Week 6 change from day 10||||<0.0001
73963058|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.041|||||||Sign test|||Change in Visible Test Abutment - Week 12 change from day 10||||0.041
73963059|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.0065|||||||Sign test|||Change in Visible Test Abutment - Week 24 change from day 10||||0.0065
73963060|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Sign test|||Change in Visible Test Abutment - Month 12 change from day 10||||0.0003
73963061|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.028|||||||Sign test|||Change in Visible Test Abutment - Month 24 change from day 10||||0.028
73963062|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.037|||||||Sign test|||Change in Visible Test Abutment - Month 36 change from day 10||||0.037
73963063|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.072|||||||Sign test|||Change in Visible Control Abutment - Week 3 change from day 10||||0.072
73963064|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.034|||||||Sign test|||Change in Visible Control Abutment - Week 6 change from day 10||||0.034
73963065|NCT01796236|147461943|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Visible Control Abutment - Week 12 change from day 10||||<0.0001
73963066|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.01|||||||Sign test|||Change in Visible Control Abutment - Week 24 change from day 10||||0.010
73963067|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.0086|||||||Sign test|||Change in Visible Control Abutment - Month 12 change from day 10||||0.0086
73963068|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.0021|||||||Sign test|||Change in Visible Control Abutment - Month 24 change from day 10||||0.0021
73963069|NCT01796236|147461943|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Sign test|||Change in Visible Control Abutment - Month 36 change from day 10||||0.0005
73963070|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||Week 12: Vascularity (observer)||||0.026
73963071|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vascularity (observer)||||0.33
73963072|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vascularity (observer)||||0.094
73963073|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pigmentation (observer)||||0.30
73963074|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pigmentation (observer)||||0.23
73963075|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pigmentation (observer)||||0.48
73963076|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (observer)||||0.0003
74025393|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 2 between the two arms"||||0.11
74025394|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.15|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 2 between the two arms"||||0.15
73855325|NCT00425698|147257428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: Erythopoietin significantly improves kidney graft function. Power calculation: with a difference of at least 4 mL/min in mean eGFR between groups the number of patients enrolled per group (at least 41) would allowed the detection of a significant difference between groups at a 5% level (p\<0.05)||||<0.05
73855326|NCT01709422|147257458|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2||||0.05||95.0|||||Chi-squared|||||||0.05
73855327|NCT01709422|147257459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.05
73855328|NCT02516098|147257462|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the test and reference product (for Stage 1) was assessed on the basis of the point estimate of the geometric mean ratio for Cmax in relation to the bioequivalence range of 80.00% to 125.00%.|Geometric mean ratio (%): T/REF|87.52|||||TWO_SIDED|92.46|77.18|99.24|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).||99.24|77.18|
73855329|NCT02516098|147257463|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the test and reference products for Stage 1 was assessed on the basis of the 92.46% confidence intervals for the geometric mean (test/reference) ratio for the AUC0-t in relation to the bioequivalence range of 80.00% to 125.00%, with a one-sided alpha of 0.0377.|Geometric mean ratio (%): T/REF|91.74|||||TWO_SIDED|92.46|83.51|100.78|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).||100.78|83.51|
73855330|NCT02516098|147257464|SUPERIORITY_OR_OTHER||Geometric mean ratio (%): T/REF|91.66|||||TWO_SIDED|92.46|83.59|100.51|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.||100.51|83.59|
73855331|NCT02516098|147257465|SUPERIORITY_OR_OTHER||Geometric mean ratio (%): T/REF|92.96|||||TWO_SIDED|92.46|81.94|105.47|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.||105.47|81.94|
73855332|NCT03831191|147257486|SUPERIORITY||Odds Ratio (OR)|0.55||||0.638|TWO_SIDED|95.0|0.04|6.81|||Regression, Logistic|||||6.81|0.04|0.638
74084999|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|1.5|||||TWO_SIDED|95.0|-2.6|5.6|||||Pain Interference - Medium vs Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||5.6|-2.6|
73855333|NCT03831191|147257486|SUPERIORITY||Odds Ratio (OR)|0.69||||0.773|TWO_SIDED|95.0|0.05|8.76|||Regression, Logistic|||||8.76|0.05|0.773
73855334|NCT03831191|147257486|SUPERIORITY||Odds Ratio (OR)|0.58||||0.671|TWO_SIDED|95.0|0.05|7.26|||Regression, Logistic|||||7.26|0.05|0.671
73855335|NCT03831191|147257487|SUPERIORITY||Risk Difference (RD)|-4.0|||>|0.999|TWO_SIDED|95.0|-27.2|19.9|||Fisher Exact|||||19.9|-27.2|>0.999
73855336|NCT03831191|147257487|SUPERIORITY||Risk Difference (RD)|4.5|||>|0.999|TWO_SIDED|95.0|-20.7|30.8|||Fisher Exact|||||30.8|-20.7|>0.999
73855337|NCT03831191|147257487|SUPERIORITY||Risk Difference (RD)|-19.0||||0.107|TWO_SIDED|95.0|-40.0|0.2|||Fisher Exact|||||0.2|-40.0|0.107
73855338|NCT03831191|147257488|SUPERIORITY||Risk Difference (RD)|0.2|||>|0.999|TWO_SIDED|95.0|-18.1|19.3|||Fisher Exact|||||19.3|-18.1|>0.999
73855339|NCT03831191|147257488|SUPERIORITY||Risk Difference (RD)|-4.8|||>|0.999|TWO_SIDED|95.0|-22.7|14.1|||Fisher Exact|||||14.1|-22.7|>0.999
73855340|NCT03831191|147257488|SUPERIORITY||Risk Difference (RD)|-4.8|||>|0.999|TWO_SIDED|95.0|-22.7|11.2|||Fisher Exact|||||11.2|-22.7|>0.999
73855341|NCT03831191|147257489|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
73855342|NCT03831191|147257489|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
73855343|NCT03831191|147257489|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
73855344|NCT03831191|147257490|SUPERIORITY||Median Difference (Net)|6.55||||0.31|TWO_SIDED|95.0|-6.36|19.45|||Mixed Models Analysis|||||19.45|-6.36|0.310
73855345|NCT03831191|147257490|SUPERIORITY||Mean Difference (Net)|5.56||||0.393|TWO_SIDED|95.0|-7.5|18.63|||Mixed Models Analysis|||||18.63|-7.50|0.393
73855346|NCT03831191|147257490|SUPERIORITY||Mean Difference (Net)|3.59||||0.564|TWO_SIDED|95.0|-8.91|16.08|||Mixed Models Analysis|||||16.08|-8.91|0.564
73855347|NCT03831191|147257491|SUPERIORITY||Mean Difference (Net)|7.61||||0.356|TWO_SIDED|95.0|-8.82|24.05|||Mixed Models Analysis|||||24.05|-8.82|0.356
73855348|NCT03831191|147257491|SUPERIORITY||Mean Difference (Net)|2.33||||0.783|TWO_SIDED|95.0|-14.64|19.3|||Mixed Models Analysis|||||19.30|-14.64|0.783
73855349|NCT03831191|147257491|SUPERIORITY||Mean Difference (Net)|6.52||||0.414|TWO_SIDED|95.0|-9.4|22.43|||Mixed Models Analysis|||||22.43|-9.40|0.414
73963077|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (observer)||||0.062
73905325|NCT01074047|147341323|SUPERIORITY_OR_OTHER||Difference|12.26|||||TWO_SIDED|95.0|3.5|21.0|||||Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.|||21.0|3.5|
73905326|NCT01074047|147341324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1495|TWO_SIDED|95.0|0.72|1.05|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of EFS||1.05|0.72|0.1495
74085000|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|-5.4|||||TWO_SIDED|95.0|-9.8|1.0|||||Pain Interference - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||1.0|-9.8|
73905327|NCT01074047|147341325|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5832|TWO_SIDED|95.0|0.75|1.66|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of RFS||1.66|0.75|0.5832
73905328|NCT01074047|147341326|SUPERIORITY_OR_OTHER|||||||0.5384|||||||Fisher Exact|P-value is from Fishers exact test||||||0.5384
73905329|NCT01074047|147341328|SUPERIORITY_OR_OTHER|||||||0.0376|||||||Fisher Exact|P-value is from Fishers exact test||||||0.0376
73905330|NCT01074047|147341352|SUPERIORITY_OR_OTHER||Relative Ratio|0.79||||0.0721|TWO_SIDED|95.0|0.62|1.02|||negative binomial regression analysis|||||1.02|0.62|0.0721
73905331|NCT02247531|147341357|SUPERIORITY||Difference in Adjusted Means|0.157||||0.0479|TWO_SIDED|95.0|0.001|0.313|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.313|0.001|0.0479
73905332|NCT02247531|147341357|SUPERIORITY||Difference in Adjusted Means|0.087||||0.2739|TWO_SIDED|95.0|-0.069|0.243|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.243|-0.069|0.2739
73963078|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (observer)||||0.11
73905333|NCT02247531|147341358|SUPERIORITY||Difference in Adjusted Means|-0.4||||0.84|TWO_SIDED|95.0|-4.8|3.9|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||3.9|-4.8|0.8400
73905334|NCT02247531|147341358|SUPERIORITY||Difference in Adjusted Means|1.3||||0.5587|TWO_SIDED|95.0|-3.1|5.7|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||5.7|-3.1|0.5587
73905335|NCT02247531|147341359|SUPERIORITY||Difference in Adjusted Means|0.1||||0.8358|TWO_SIDED|95.0|-0.88|1.09|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||1.09|-0.88|0.8358
73905336|NCT02247531|147341359|SUPERIORITY||Difference in Adjusted Means|-0.26||||0.6117|TWO_SIDED|95.0|-1.25|0.74|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.74|-1.25|0.6117
73905337|NCT02247531|147341360|SUPERIORITY||Difference in Adjusted Means|0.7||||0.4651|TWO_SIDED|95.0|-1.2|2.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.5|-1.2|0.4651
73905338|NCT02247531|147341360|SUPERIORITY||Difference in Adjusted Means|0.3||||0.7885|TWO_SIDED|95.0|-1.6|2.1|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.1|-1.6|0.7885
73905339|NCT02247531|147341361|SUPERIORITY||Odds Ratio (OR)|1.1||||0.6892|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||||1.8|0.7|0.6892
73905340|NCT02247531|147341361|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9104|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.9104
73905341|NCT02247531|147341362|SUPERIORITY||Difference in Adjusted Means|-0.1||||0.8931|TWO_SIDED|95.0|-1.8|1.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.5|-1.8|0.8931
73963079|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Relief (observer)||||0.0003
73963080|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 12: Relief (observer)||||0.079
73963081|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||Month 36: Relief (observer)||||0.025
73963082|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pliability (observer)||||0.0020
73963083|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pliability (observer)||||0.14
73963084|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pliability (observer)||||0.0014
73963085|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 12: Surface Area (observer)||||0.0001
73963086|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Month 12: Surface Area (observer)||||0.023
73963087|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||Month 36: Surface Area (observer)||||0.045
73963088|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (observer)||||0.0005
73963089|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (observer)||||0.085
73963090|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (observer)||||0.030
73963091|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (observer)||||0.0015
73963092|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.076|||||||Wilcoxon (Mann-Whitney)|||Month 12: Overall Opinion (observer)||||0.076
73905342|NCT02247531|147341362|SUPERIORITY||Difference in Adjusted Means|-1.1||||0.1754|TWO_SIDED|95.0|-2.8|0.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||0.5|-2.8|0.1754
73905343|NCT02247531|147341363|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3707|TWO_SIDED|95.0|0.7|2.2|||Regression, Logistic|||||2.2|0.7|0.3707
73905344|NCT02247531|147341363|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8382|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.8382
73905345|NCT02247531|147341364|SUPERIORITY||Difference in Adjusted Means|1.35||||0.6841|TWO_SIDED|95.0|-5.16|7.85|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||7.85|-5.16|0.6841
73905346|NCT02247531|147341364|SUPERIORITY||Difference in Adjusted Means|1.07||||0.7443|TWO_SIDED|95.0|-5.37|7.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||7.52|-5.37|0.7443
73905347|NCT02247531|147341365|SUPERIORITY||Difference in Adjusted Means|0.12||||0.9713|TWO_SIDED|95.0|-6.28|6.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.||6.52|-6.28|0.9713
73963093|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (observer)||||0.15
73963094|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12: Painful (patient)||||0.72
73963095|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12: Painful (patient)||||0.97
73905348|NCT02247531|147341365|SUPERIORITY||Difference in Adjusted Means|-1.72||||0.5945|TWO_SIDED|95.0|-8.08|4.63|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.||4.63|-8.08|0.5945
73905349|NCT02247531|147341366|SUPERIORITY||Difference in Adjusted Means|1.22||||0.2438|TWO_SIDED|95.0|-0.83|3.27|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.27|-0.83|0.2438
73905350|NCT02247531|147341366|SUPERIORITY||Difference in Adjusted Means|1.03||||0.3202|TWO_SIDED|95.0|-1.01|3.07|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.07|-1.01|0.3202
74025395|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 2 between the two arms."|Difference in Change|0.22||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 2 between the two arms"||||0.08
73905351|NCT02247531|147341367|SUPERIORITY||Difference in Adjusted Means|2.64||||0.0388|TWO_SIDED|95.0|0.14|5.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||5.14|0.14|0.0388
73905352|NCT02247531|147341367|SUPERIORITY||Difference in Adjusted Means|2.2||||0.0833|TWO_SIDED|95.0|-0.29|4.68|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||4.68|-0.29|0.0833
73963096|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Month 36: Painful (patient)||||0.82
73963097|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Week 12: Itching (patient)||||0.86
73963098|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 12: Itching (patient)||||0.84
73963099|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Itching (patient)||||0.76
73963100|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 12: Color (patient)||||0.41
73963101|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Month 12: Color (patient)||||0.98
73963102|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Color (patient)||||0.76
73963103|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 12: Stiffness (patient)||||0.43
73963104|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 12: Stiffness (patient)||||0.25
73963105|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||Month 36: Stiffness (patient)||||0.017
73963106|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (patient)||||0.13
73963107|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (patient)||||0.33
73963108|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (patient)||||0.65
73963109|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Week 12: Irregularity (patient)||||0.18
73963110|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Irregularity (patient)||||0.38
73963111|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Month 36: Irregularity (patient)||||0.080
73963112|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (patient)||||0.28
73963113|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (patient)||||0.44
73905353|NCT02247531|147341368|SUPERIORITY||Difference in Adjusted Means|1.04||||0.4795|TWO_SIDED|95.0|-1.84|3.91|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.91|-1.84|0.4795
73905354|NCT02247531|147341368|SUPERIORITY||Difference in Adjusted Means|0.6||||0.6822|TWO_SIDED|95.0|-2.26|3.45|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.45|-2.26|0.6822
73905355|NCT02247531|147341369|SUPERIORITY||Difference in Adjusted Means|0.04||||0.5227|TWO_SIDED|95.0|-0.07|0.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.14|-0.07|0.5227
73905356|NCT02247531|147341369|SUPERIORITY||Difference in Adjusted Means|0.02||||0.7475|TWO_SIDED|95.0|-0.09|0.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.13|-0.09|0.7475
73905357|NCT02247531|147341370|SUPERIORITY||Difference in Adjusted Means|0.049||||0.6333|TWO_SIDED|95.0|-0.153|0.252|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.252|-0.153|0.6333
73905358|NCT02247531|147341370|SUPERIORITY||Difference in Adjusted Means|0.025||||0.8105|TWO_SIDED|95.0|-0.18|0.23|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.230|-0.180|0.8105
73963114|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (patient)||||0.19
73963115|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)||||0.16
74025396|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean depression score from period 1 to period 2 between the two arms."|Difference in Change|0.34||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 2 between the two arms"||||0.02
73905359|NCT02247531|147341370|SUPERIORITY||Difference in Adjusted Means|0.34||||0.0063|TWO_SIDED|95.0|0.097|0.584|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.584|0.097|0.0063
73905360|NCT02247531|147341370|SUPERIORITY||Difference in Adjusted Means|0.182||||0.1359|TWO_SIDED|95.0|-0.058|0.422|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.422|-0.058|0.1359
73905361|NCT01068652|147341420|NON_INFERIORITY_OR_EQUIVALENCE|The treatment comparison was based on a non-inferiority criterion and the following hypotheses were tested: H0: μDetemir - μBIAsp 30 ≥0.4% against the alternative hypothesis (Detemir non-inferior to BIAsp 30) HA: μDetemir - μBIAsp 30 \<0.4% where μBIAsp 30 and μDetemir are the mean HbA1c after 50 weeks of treatment with the two treatment regimens.|Mean Difference (Final Values)|0.11||||0.3406||95.0|-0.12|0.34|||ANCOVA|||To investigate the effect of different treatments, an analysis of covariance (ANCOVA) model was used to analyse HbA1c at week 50 with treatment group (2 categories: insulin detemir and aspart; BIAsp 30), country and pre-trial OAD(s) treatment (one OAD vs. more OADs) as factors and HbA1c at baseline (week 0) as a covariate. The treatment difference was estimated and a 95% confidence interval (CI) for the difference was calculated.||0.34|-0.12|0.3406
73905362|NCT02694523|147341437|OTHER||difference in percentage of participants|24.9|||<|0.001|TWO_SIDED|95.0|17.5|32.4|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to tumor necrosis factor (TNF) antagonists (0 vs ≥1).||32.4|17.5|<0.001
73905363|NCT02694523|147341438|OTHER||difference in percentage of participants|23.3|||<|0.001|TWO_SIDED|95.0|16.6|30.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||30.1|16.6|<0.001
73905364|NCT02694523|147341439|OTHER||difference in percentage of participants|45.0|||<|0.001|TWO_SIDED|95.0|28.9|61.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||61.1|28.9|<0.001
73905365|NCT02694523|147341440|OTHER||difference in percentage of participants|18.9|||<|0.001|TWO_SIDED|95.0|13.0|24.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||24.9|13.0|<0.001
73963116|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)||||0.23
73963117|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (patient)||||0.079
73963118|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pain not within Scar (patient)||||0.0018
73963119|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain not within Scar (patient)||||0.053
73963120|NCT01796236|147461944|SUPERIORITY_OR_OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain not within Scar (patient)||||0.068
73963121|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI3)||||0.90
73963122|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI3)||||0.43
73963123|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI3)||||0.23
73905366|NCT02694523|147341441|OTHER||difference in percentage of participants|16.7|||<|0.001|TWO_SIDED|95.0|9.5|23.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||23.9|9.5|<0.001
73905367|NCT02694523|147341442|OTHER||difference in percentage of participants|32.8|||<|0.001|TWO_SIDED|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||46.9|18.8|<0.001
73905368|NCT02694523|147341443|OTHER||difference in percentage of participants|32.8|||<|0.001|TWO_SIDED|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||46.9|18.8|<0.001
73905369|NCT02694523|147341444|OTHER||difference in percentage of participants|38.9|||<|0.001|TWO_SIDED|95.0|22.0|55.8|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||55.8|22.0|<0.001
73905370|NCT05323656|147341508|SUPERIORITY||LS Mean Difference|5.05|STANDARD_ERROR_OF_MEAN|13.077||0.7008|TWO_SIDED|80.0|-11.98|22.0|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group|Null hypothesis: the mean best percentage change in the tumour size between the treatment groups are the same. With 25 patients per treatment group, using a 2-sided t-test, there will be 85% power to detect a 20% mean difference between the treatment groups in best percentage change in tumour size, with an estimated standard deviation of 30% and a 2 sided alpha of 20%.||22.0|-11.98|0.7008
73905371|NCT05323656|147341509|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.1023|TWO_SIDED|80.0|0.38|0.89|||Regression, Cox|||Null hypothesis: The risk for progression, as defined by RECIST v1.1, is the same between treatment groups. If the true hazard ratio is 0.5, approximately 38 progression events as defined by RECIST v1.1 will be required to have \> 80% power to demonstrate a statistically significant difference in PFS with 2-sided p\<0.2||0.89|0.38|.1023
73905372|NCT05323656|147341510|SUPERIORITY||LS Mean Difference|9.5|STANDARD_ERROR_OF_MEAN|8.89||0.2986|TWO_SIDED|80.0|-2.3|21.3||a priori threshold for significance (0.2) not met.|ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline CAF levels does not differ between treatment groups. ANCOVA model is on postbaseline CAFs level with a fixed factor for treatment and a covariate for baseline.||21.3|-2.3|0.2986
73905373|NCT05323656|147341511|SUPERIORITY||LS Mean Difference|6.83|STANDARD_ERROR_OF_MEAN|12.48||0.5918|TWO_SIDED|80.0|-9.86|23.52|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline CD8+ TILs does not differ between treatment groups. ANCOVA model is on postbaseline CD8+ TILs level with a fixed factor for treatment and a covariate for baseline.||23.52|-9.86|0.5918
73905374|NCT05323656|147341512|SUPERIORITY||LS Mean Difference|10.84|STANDARD_ERROR_OF_MEAN|8.37||0.2135|TWO_SIDED|80.0|-0.34|22.02|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline number of regulatory T-cells in tumour tissue does not differ between treatment groups. ANCOVA model is on postbaseline number of regulatory T-cells in tumour tissue level with a fixed factor for treatment and a covariate for baseline.||22.02|-0.34|0.2135
73963124|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI3)||||0.019
73905375|NCT05323656|147341516|SUPERIORITY||Hazard Ratio (HR)|0.448|||||TWO_SIDED|80.0|0.24|0.85||||||No formal test of significance undertaken.||0.85|0.24|
73905376|NCT05323656|147341519|SUPERIORITY||Mean Difference (Final Values)|17.76|STANDARD_ERROR_OF_MEAN|9.4||0.0782|TWO_SIDED|80.0|5.17|30.36|||ANCOVA|The LS Mean difference is for the Setanaxib Group minus the Placebo Group.||Null Hypothesis: Mean difference in postbaseline PD-L1 combined positive score (CPS) does not differ between treatment groups. ANCOVA model is on postbaseline PD-L1 CPS with a fixed factor for treatment and a covariate for baseline. Threshold for statistical significance = 0.2.||30.36|5.17|0.0782
73905377|NCT05323656|147341520|OTHER||Mean Difference (Net)|0.11|STANDARD_DEVIATION|0.578||0.22|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.22
73905378|NCT05323656|147341520|OTHER||Mean Difference (Net)|-0.18|STANDARD_DEVIATION|0.395||0.2|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.20
73905379|NCT05323656|147341521|OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.069||0.037|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.037
73905380|NCT05323656|147341521|OTHER||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.039||0.123|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.123
73905381|NCT05323656|147341522|OTHER||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.017||0.41|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.41
74025397|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.36||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 2 between the two arms"||||0.01
73905382|NCT05323656|147341522|OTHER||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.023||0.11|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.11
73963125|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Baseline: Vision (HUI3)||||0.079
73963126|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Vision (HUI3)||||0.96
73963127|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vision (HUI3)||||0.55
73963128|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vision (HUI3)||||0.64
73905383|NCT04010539|147341561|NON_INFERIORITY|The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Non-inferiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above -10.0%.|Adjusted Difference in Percent|-0.1|||||TWO_SIDED|95.0|-5.6|5.5||||||||5.5|-5.6|
73905384|NCT04010539|147341561|SUPERIORITY|The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Superiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above 0.0%.|Adjusted Difference in Percent|-0.1||||0.5072|TWO_SIDED|95.0|-5.6|5.5|||1-sided p-value for Test of Superiority|||||5.5|-5.6|0.5072
73905385|NCT04795622|147341596|SUPERIORITY||Odds Ratio (OR)|1.3545|||||TWO_SIDED|95.0|0.753|2.4365||||||||2.4365|0.7530|
74025398|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 3 between the two arms."|Difference in Change|-0.27||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 3 between the two arms"||||0.08
73855350|NCT02300558|147257494|OTHER|||||||0.0087|||||||paired t- test|||Based on a 2-sided, paired t-test ( α = 0.05), and a standard deviation (SD) of 30 msec, a sample size of 40 participants provided greater than 95% power assuming a difference in mean daytime QTcF interval (AUC0-6/6) as measured by standard 12-lead ECG between baseline and Week 24 of 20 msec. The null hypothesis was that the mean difference between the baseline and Week 24 mean daytime QTcF interval was zero.||||0.0087
73855351|NCT02135029|147257516|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-54.5|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-60.1|-49.0|||MMRM|Mixed Model Repeated Measures (MMRM)|LS-mean differences,associated 95% confidence interval (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit,treatment group\*visit interaction,baseline value, baseline value\*visit\*group interaction, country.|||-49.0|-60.1|<0.001
73855352|NCT02135029|147257517|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-42.6|-34.2|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-34.2|-42.6|<0.001
73855353|NCT02135029|147257517|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-35.9|-26.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-26.2|-35.9|
73905386|NCT04795622|147341597|SUPERIORITY||Point Estimate|-0.0856|||||TWO_SIDED|95.0|-0.2395|0.0683||||||X-axis||0.0683|-0.2395|
73905387|NCT04795622|147341597|SUPERIORITY||Point Estimate|-0.033|||||TWO_SIDED|95.0|-0.2268|0.1608||||||Y-axis||0.1608|-0.2268|
73905388|NCT04795622|147341597|SUPERIORITY||Point Estimate|0.1791|||||TWO_SIDED|95.0|-0.1551|0.5133||||||Z-axis||0.5133|-0.1551|
73905389|NCT02398409|147341602|SUPERIORITY||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.117||0.8407|TWO_SIDED|||||Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.|Mixed Models Analysis|||12 weeks compared to Baseline (BL)||||.8407
73905390|NCT02398409|147341602|SUPERIORITY||Median Difference (Net)|0.201|STANDARD_ERROR_OF_MEAN|0.12||0.015|TWO_SIDED|||||Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.|Mixed Models Analysis|||At 6 months compared to BL||||.0150
74085001|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|-2.2|3.8|||||Physical Function - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Function||3.8|-2.2|
73855354|NCT02135029|147257518|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.5|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|-51.9|-41.1|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-41.1|-51.9|<0.001
73855355|NCT02135029|147257518|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-45.4|-33.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-33.2|-45.4|
73855356|NCT02135029|147257519|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.2|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-56.3|-46.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-46.0|-56.3|<0.001
73855357|NCT02135029|147257519|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-47.7|-35.8|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-35.8|-47.7|
73905391|NCT02398409|147341602|SUPERIORITY||Median Difference (Net)|0.114|STANDARD_ERROR_OF_MEAN|0.188||0.8373|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared BL||||.8373
73905392|NCT02398409|147341603|SUPERIORITY||Median Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.173||0.6445|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||12 weeks compared to BL||||.6445
73905393|NCT02398409|147341603|SUPERIORITY||Median Difference (Net)|0.033|STANDARD_ERROR_OF_MEAN|0.158||0.5247|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||6 months compared to BL||||.5247
73963129|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Baseline: Hearing (HUI3)||||0.76
73905394|NCT02398409|147341603|SUPERIORITY||Median Difference (Net)|0.1224|STANDARD_ERROR_OF_MEAN|0.187||0.9974|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.9974
73905395|NCT02398409|147341604|SUPERIORITY||Median Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.087||0.1918|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||12 weeks compared to BL||||.1918
73905396|NCT02398409|147341604|SUPERIORITY||Median Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.078||0.9212|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||6 months compared to BL||||.9212
73905397|NCT02398409|147341604|SUPERIORITY||Median Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.083||0.2358|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.2358
73905398|NCT02398409|147341605|SUPERIORITY|adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Median Difference (Net)|0.008|STANDARD_ERROR_OF_MEAN|0.168||0.1107|TWO_SIDED||||||Mixed Models Analysis|||12 weeks compared to BL||||.1107
73905399|NCT02398409|147341605|SUPERIORITY|adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Median Difference (Net)|0.251|STANDARD_ERROR_OF_MEAN|0.211||0.0562|TWO_SIDED||||||Mixed Models Analysis|||6 months compared to BL||||.0562
73905400|NCT02398409|147341605|SUPERIORITY||Median Difference (Net)|0.226|STANDARD_ERROR_OF_MEAN|0.218||0.8579|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.8579
73905401|NCT00089674|147341611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||<|0.0001||95.0|6.2|7.1|||ANCOVA|||||7.1|6.2|<0.0001
73905402|NCT00089674|147341612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||<|0.0001||95.0|3.5|4.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||4.4|3.5|<0.0001
73905403|NCT00089674|147341613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|||<|0.0001||95.0|4.4|5.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||5.1|4.4|<0.0001
73905404|NCT00089674|147341614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|7.4|8.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||8.4|7.4|<0.0001
73905405|NCT00089674|147341615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|||<|0.0001||95.0|4.4|5.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||5.4|4.4|<0.0001
73905406|NCT00089674|147341616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|||<|0.0001||95.0|5.4|6.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||6.1|5.4|<0.0001
73905407|NCT00089674|147341617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.1048||95.0|0.46|1.08||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||1.08|0.46|0.1048
73905408|NCT00089674|147341618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.0125||95.0|0.18|0.78||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||0.78|0.18|0.0125
73905409|NCT00089674|147341619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.7961||95.0|0.57|1.55||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Cox|||||1.55|0.57|0.7961
73905410|NCT00089674|147341620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.7961||95.0|0.44|1.11||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||1.11|0.44|0.7961
73905411|NCT03963401|147341621|SUPERIORITY||Mean Difference (Final Values)|21.23|STANDARD_ERROR_OF_MEAN|10.51||0.1172|TWO_SIDED|90.0|3.94|38.52|||Normal approximation, Dunnett's method|||||38.52|3.94|0.1172
74085002|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-2.9|3.2|||||Physical Function - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Funtion||3.2|-2.9|
73905412|NCT03963401|147341621|SUPERIORITY||Median Difference (Final Values)|23.38|STANDARD_ERROR_OF_MEAN|8.58||0.0197|TWO_SIDED|90.0|9.26|37.5|||Normal approximation, Dunnett's Method|||||37.50|9.26|0.0197
73905413|NCT03963401|147341621|SUPERIORITY||Median Difference (Final Values)|31.29|STANDARD_ERROR_OF_MEAN|8.29||0.0006|TWO_SIDED|90.0|17.65|44.93|||Normal approximation, Dunnett's Method|||||44.93|17.65|0.0006
73905414|NCT03963401|147341622|SUPERIORITY||Mean Difference (Final Values)|20.95|STANDARD_ERROR_OF_MEAN|11.09||0.0588|TWO_SIDED|90.0|2.72|39.19|||Normal approximation method|||||39.19|2.72|0.0588
73905415|NCT03963401|147341622|SUPERIORITY||Median Difference (Final Values)|26.31|STANDARD_ERROR_OF_MEAN|8.87||0.003|TWO_SIDED|90.0|11.72|40.9|||Normal approximation method|||||40.90|11.72|0.0030
73905416|NCT03963401|147341622|SUPERIORITY||Median Difference (Final Values)|31.21|STANDARD_ERROR_OF_MEAN|8.68||0.0003|TWO_SIDED|90.0|16.93|45.5|||Normal approximation method|||||45.50|16.93|0.0003
73905417|NCT02961218|147341657|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_DEVIATION|0.57||0.55|TWO_SIDED|90.0|-1.03|0.85||probability reduction of average pain score in ACZ885 \> Placebo|Bayesian model for repeated measures||Lower limit and upper limit represents the credibility interval from the Bayesian analysis.|||0.85|-1.03|0.55
73905418|NCT02961218|147341659|SUPERIORITY||Ratio|0.408||||0.002|TWO_SIDED|90.0|0.253|0.658|||Mixed-effect Model for Repeated Measures|||||0.658|0.253|0.002
73905419|NCT02961218|147341660|SUPERIORITY||Ratio|0.752|||<|0.001|TWO_SIDED|90.0|0.657|0.862|||Mixed-effect Model for Repeated Measures|||||0.862|0.657|<.001
73905420|NCT02961218|147341661|SUPERIORITY||Ratio|0.682||||0.004|TWO_SIDED|90.0|0.547|0.849|||Mixed-effect Model for Repeated Measures|||||0.849|0.547|0.004
73905421|NCT02961218|147341662|SUPERIORITY||Ratio|0.718||||0.032|TWO_SIDED|90.0|0.556|0.925|||Mixed-effect Model for Repeated Measures|||||0.925|0.556|0.032
73905422|NCT02961218|147341669|SUPERIORITY||Ratio|1.4|STANDARD_ERROR_OF_MEAN|0.45||0.455|TWO_SIDED|90.0|0.58|3.4|||Generalized Linear Model (GLM)|||||3.40|0.58|0.455
73963130|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||Week 24: Hearing (HUI3)||||0.059
73963131|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Hearing (HUI3)||||0.38
73905423|NCT00591266|147341678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.19|||<|0.001|TWO_SIDED|95.0|-13.29|-9.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-9.09|-13.29|<0.001
73905424|NCT00591266|147341678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.91|||<|0.001|TWO_SIDED|95.0|-13.0|-8.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-8.81|-13.00|<0.001
73905425|NCT00591266|147341679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02|||<|0.001|TWO_SIDED|95.0|-13.93|-8.1||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-8.10|-13.93|<0.001
73963132|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Hearing (HUI3)||||0.14
73963133|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Baseline: Speech (HUI3)||||0.73
73963134|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Week 24: Speech (HUI3)||||0.65
73963135|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Month 12: Speech (HUI3)||||1.00
73905426|NCT00591266|147341679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.56|||<|0.001|TWO_SIDED|95.0|-12.48|-6.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-6.63|-12.48|<0.001
73905427|NCT00591266|147341680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.48|||<|0.001|TWO_SIDED|95.0|-8.84|-6.11||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.11|-8.84|<0.001
73905428|NCT00591266|147341680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.65|||<|0.001|TWO_SIDED|95.0|-9.01|-6.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.28|-9.01|<0.001
73905429|NCT00591266|147341681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.93|||<|0.001|TWO_SIDED|95.0|-6.62|-3.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.23|-6.62|<0.001
73905430|NCT00591266|147341681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.58|||<|0.001|TWO_SIDED|95.0|-7.28|-3.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.88|-7.28|<0.001
73905431|NCT00591266|147341682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.64|||<|0.001|TWO_SIDED|95.0|-13.86|-9.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.41|-13.86|<0.001
73905432|NCT00591266|147341682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.17|||<|0.001|TWO_SIDED|95.0|-13.39|-8.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.95|-13.39|<0.001
73905433|NCT00591266|147341683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.99|||<|0.001|TWO_SIDED|95.0|-9.47|-6.5||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.50|-9.47|<0.001
73905434|NCT00591266|147341683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.04|||<|0.001|TWO_SIDED|95.0|-9.52|-6.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.55|-9.52|<0.001
73905435|NCT00591266|147341684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||<|0.001|TWO_SIDED|95.0|-12.07|-7.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.34|-12.07|<0.001
73963136|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||Month 36: Speech (HUI3)||||0.35
73963137|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ambulation (HUI3)||||0.50
73963138|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ambulation (HUI3)||||0.40
73963139|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ambulation (HUI3)||||0.21
73963140|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ambulation (HUI3)||||0.0010
73963141|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI3)||||0.13
73963142|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI3)||||0.96
73963143|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI3)||||0.75
73963144|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI3)||||0.20
73963145|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI3)||||0.95
73963146|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI3)||||0.31
73963147|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI3)||||0.15
73963148|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI3)||||0.19
73963149|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI3)||||0.41
73963150|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI3)||||0.30
73963151|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI3)||||0.42
74025399|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 3 between the two arms"||||0.08
73855358|NCT02135029|147257520|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.3|STANDARD_ERROR_OF_MEAN|6.32|<|0.001|TWO_SIDED|95.0|-35.7|-10.8|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-10.8|-35.7|<0.001
73855359|NCT02135029|147257520|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|6.21|||TWO_SIDED|95.0|-29.6|-5.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-5.1|-29.6|
73855360|NCT02135029|147257521|SUPERIORITY_OR_OTHER||LS Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|7.8|17.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||17.0|7.8|<0.001
73855361|NCT02135029|147257521|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|6.7|16.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||16.4|6.7|
73855362|NCT02135029|147257522|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.8|STANDARD_ERROR_OF_MEAN|3.33|||TWO_SIDED|95.0|-51.3|-38.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-38.2|-51.3|
73855363|NCT02135029|147257523|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-5.2|-23.5|
73855364|NCT02135029|147257523|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|5.14|||TWO_SIDED|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||0.4|-19.8|
73855365|NCT02135029|147257524|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|2.2|10.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||10.1|2.2|
73905436|NCT00591266|147341684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.67|||<|0.001|TWO_SIDED|95.0|-12.03|-7.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.31|-12.03|<0.001
73905437|NCT00591266|147341685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.26|||<|0.001|TWO_SIDED|95.0|-7.94|-4.57||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.57|-7.94|<0.001
74085003|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-2.4|3.7|||||Physical Function- High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population|Physical Function||3.7|-2.4|
74085004|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|5.8|||||TWO_SIDED|95.0|1.1|10.5|||||Fatigue - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||10.5|1.1|
73855366|NCT02135029|147257524|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|2.09|||TWO_SIDED|95.0|1.5|9.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||9.7|1.5|
73855367|NCT02135029|147257525|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|0.8|8.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||8.7|0.8|
73855368|NCT02135029|147257525|SUPERIORITY_OR_OTHER||LS Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|95.0|2.4|10.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||10.5|2.4|
73855369|NCT02135029|147257526|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-5.2|-23.5|
73855370|NCT02135029|147257526|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|5.14|||TWO_SIDED|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||0.4|-19.8|
73855371|NCT02135029|147257527|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.8|STANDARD_ERROR_OF_MEAN|4.93|||TWO_SIDED|95.0|-103.5|-84.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-84.1|-103.5|
73855372|NCT02135029|147257528|SUPERIORITY_OR_OTHER||LS Mean Difference|-98.7|STANDARD_ERROR_OF_MEAN|5.67|||TWO_SIDED|95.0|-109.9|-87.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-87.5|-109.9|
73855373|NCT02135029|147257529|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|3.7|8.0|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||8.0|3.7|
73855374|NCT02135029|147257530|SUPERIORITY_OR_OTHER||LS Mean Difference|-103.6|STANDARD_ERROR_OF_MEAN|5.56|||TWO_SIDED|95.0|-114.6|-92.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-92.7|-114.6|
74025400|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 3 between the two arms"||||0.08
73855375|NCT02135029|147257532|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|3.46|||TWO_SIDED|95.0|-66.0|-52.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-52.4|-66.0|
73855376|NCT02135029|147257533|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-8.7|-4.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-4.5|-8.7|
73855377|NCT02135029|147257534|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-2.7|-2.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-2.1|-2.7|
73855378|NCT02135029|147257534|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-2.4|-1.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-1.7|-2.4|
73855379|NCT02135029|147257535|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.5|-0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-0.4|-0.5|
74085005|NCT01765751|147723638|SUPERIORITY||Median Difference (Net)|3.3|||||TWO_SIDED|95.0|-1.5|8.2|||||Fatigue - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||8.2|-1.5|
74085006|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|2.5|||||TWO_SIDED|95.0|-2.3|7.3|||||Fatigue - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||7.3|-2.3|
73855380|NCT02135029|147257535|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.4|-0.3|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-0.3|-0.4|
73855381|NCT00712725|147257543|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with PF at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
73855382|NCT00712725|147257544|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response PR at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
73855383|NCT00712725|147257545|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Photophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
73855384|NCT00712725|147257546|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Phonophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
73855385|NCT00712725|147257547|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Nausea at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||0.007
73855386|NCT00712725|147257548|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response SPF 2-24 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
73855387|NCT03709277|147257552|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73855388|NCT03709277|147257553|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73855389|NCT03709277|147257555|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73855390|NCT01453205|147257586|SUPERIORITY_OR_OTHER|||||||0.5543|||||||Cochran-Mantel-Haenszel|||||||0.5543
73855391|NCT01453205|147257587|SUPERIORITY_OR_OTHER|||||||0.8567|||||||Log Rank|||||||0.8567
73855392|NCT01453205|147257588|SUPERIORITY_OR_OTHER|||||||0.7412|||||||Log Rank|||||||0.7412
73855393|NCT01453205|147257589|SUPERIORITY_OR_OTHER|||||||0.9996|||||||Log Rank|||||||0.9996
73905438|NCT00591266|147341685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.28|||<|0.001|TWO_SIDED|95.0|-7.96|-4.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.60|-7.96|<0.001
73905439|NCT00591266|147341686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.27|||<|0.001|TWO_SIDED|95.0|-14.63|-9.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.92|-14.63|<0.001
73905440|NCT00591266|147341686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|||<|0.001|TWO_SIDED|95.0|-13.93|-9.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.23|-13.93|<0.001
73905441|NCT00591266|147341687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.39|||<|0.001|TWO_SIDED|95.0|-9.98|-6.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.79|-9.98|<0.001
73905442|NCT00591266|147341687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.23|||<|0.001|TWO_SIDED|95.0|-9.82|-6.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.64|-9.82|<0.001
73963152|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI3)||||0.040
73963153|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI2)||||0.99
73963154|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI2)||||0.88
73963155|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI2)||||0.32
73963156|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.0084|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI2)||||0.0084
73963157|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Baseline: Sensation (HUI2)||||0.77
73905443|NCT00591266|147341688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83|||<|0.001|TWO_SIDED|95.0|-11.45|-6.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.22|-11.45|<0.001
73905444|NCT00591266|147341688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.91|||<|0.001|TWO_SIDED|95.0|-11.51|-6.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.30|-11.51|<0.001
73905445|NCT00591266|147341689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94|||<|0.001|TWO_SIDED|95.0|-7.88|-4.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.00|-7.88|<0.001
73905446|NCT00591266|147341689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|||<|0.001|TWO_SIDED|95.0|-8.47|-4.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.61|-8.47|<0.001
73905447|NCT00591266|147341690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.15|5.26||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.26|2.15|<0.001
73905448|NCT00591266|147341690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|2.05|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.03|2.05|<0.001
73963158|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Week 24: Sensation (HUI2)||||0.95
73963159|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Month 12: Sensation (HUI2)||||0.60
73963160|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Sensation (HUI2)||||0.48
73963161|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Baseline: Mobility (HUI2)||||0.51
73963162|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Week 24: Mobility (HUI2)||||0.42
73963163|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Month 12: Mobility (HUI2)||||0.22
73963164|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Month 36: Mobility (HUI2)||||0.0018
73963165|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI2)||||0.30
73963166|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI2)||||0.52
73963167|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI2)||||0.47
73963168|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI2)||||0.18
73963169|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI2)||||0.82
73963170|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI2)||||0.41
73963171|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI2)||||0.14
73963172|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI2)||||0.25
73963173|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Baseline: Self Care (HUI2)||||0.59
73963174|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Week 24: Self Care (HUI2)||||1.00
73963175|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Self Care (HUI2)||||0.55
73963176|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Self Care (HUI2)||||0.14
73963177|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI2)||||0.75
73963178|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI2)||||0.63
73963179|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI2)||||0.57
74025401|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean maintaining an erection score from period 1 to period 3 between the two arms."|Difference in Change|-0.13||||0.71|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in maintaining an erection score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean maintaining an erection score from period 1 to period 3 between the two arms"||||0.71
74025402|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean vomit score from period 1 to period 3 between the two arms."|Difference in Change|-0.11||||0.41|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 3 between the two arms"||||0.41
74085007|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|-0.9|3.5|||||Sleep Disturbance - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||3.5|-0.9|
74085008|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-3.6|0.9|||||Sleep Disturbance - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||0.9|-3.6|
73905449|NCT00591266|147341691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.54|||<|0.001|TWO_SIDED|95.0|2.08|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.02|2.08|<0.001
74085009|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|2.7|||||TWO_SIDED|95.0|0.4|5.0|||||Sleep Disturbance - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||5.0|0.4|
73855394|NCT01453205|147257590|SUPERIORITY_OR_OTHER|||||||0.1686|||||||Log Rank|||||||0.1686
73855395|NCT00487942|147257616|SUPERIORITY_OR_OTHER||Effect size|-0.04|||||TWO_SIDED|95.0|-0.81|0.73||Inferential statistics were not performed.|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.81|
73855396|NCT00487942|147257616|SUPERIORITY_OR_OTHER||Effect size|0.09|||||TWO_SIDED|95.0|-0.68|0.86||Inferential statistics were not performed|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.86|-0.68|
73855397|NCT00487942|147257616|SUPERIORITY_OR_OTHER||Effect size|0.15|||||TWO_SIDED|95.0|-0.66|0.95||Inferential statistics were not performed.|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.95|-0.66|
73855398|NCT00487942|147257617|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.8|0.83||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.80|
73855399|NCT00487942|147257617|SUPERIORITY_OR_OTHER||Effect size|0.31|||||TWO_SIDED|95.0|-0.51|1.14||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.14|-0.51|
73855400|NCT00487942|147257617|SUPERIORITY_OR_OTHER||Effect size|0.16|||||TWO_SIDED|95.0|-0.66|0.98||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.98|-0.66|
73855401|NCT00487942|147257618|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.51|1.01||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.51|
74025403|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 3 between the two arms."|Difference in Change|-0.08||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 3 between the two arms"||||0.84
74085010|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-4.5|3.9|||||Anxiety - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||3.9|-4.5|
73855402|NCT00487942|147257618|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.86|0.66||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.66|-0.86|
73855403|NCT00487942|147257618|SUPERIORITY_OR_OTHER||Effect size|0.49|||||TWO_SIDED|95.0|-0.31|1.28||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.28|-0.31|
73855404|NCT00487942|147257619|SUPERIORITY_OR_OTHER||Effect Size|-0.27|||||TWO_SIDED|95.0|-1.03|0.48||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.48|-1.03|
73855405|NCT00487942|147257619|SUPERIORITY_OR_OTHER||Effect Size|0.11|||||TWO_SIDED|95.0|-0.65|0.88||Inferential Statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.88|-0.65|
73855406|NCT00487942|147257619|SUPERIORITY_OR_OTHER||Effect Size|-0.18|||||TWO_SIDED|95.0|-0.97|0.6||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.60|-0.97|
73855407|NCT00487942|147257620|SUPERIORITY_OR_OTHER||Effect Size|-0.32|||||TWO_SIDED|95.0|-1.08|0.44||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.44|-1.08|
73855408|NCT00487942|147257620|SUPERIORITY_OR_OTHER||Effect Size|-0.02|||||TWO_SIDED|95.0|-0.77|0.74||Inferential Statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.74|-0.77|
73855409|NCT00487942|147257620|SUPERIORITY_OR_OTHER||Effect Size|-0.1|||||TWO_SIDED|95.0|-0.89|0.68||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.68|-0.89|
73905450|NCT00591266|147341691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.25|6.75||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.75|2.25|<0.001
73905451|NCT00591266|147341692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.001|TWO_SIDED|95.0|1.71|4.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.02|1.71|<0.001
73905452|NCT00591266|147341692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12|||<|0.001|TWO_SIDED|95.0|2.01|4.82||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.82|2.01|<0.001
74085011|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-2.9|5.1|||||Anxiety - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||5.1|-2.9|
73963180|NCT01796236|147461945|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI2)||||0.019
73963181|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Aided)||||0.047
73963182|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Aided)||||0.23
73963183|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Aided)||||0.015
73963184|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Aided)||||0.13
73963185|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Aided)||||0.041
74025404|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean urination score from period 1 to period 3 between the two arms."|Difference in Change|-0.07||||0.71|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 3 between the two arms"||||0.71
73963186|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Unaided)||||0.071
73963187|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Unaided)||||0.75
73963188|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Unaided)||||0.32
73963189|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Unaided)||||0.24
73963190|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Unaided)||||0.24
73963191|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Benefit)||||0.12
73963192|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Benefit)||||0.19
73963193|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Benefit)||||0.055
73963194|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Benefit)||||0.24
73963195|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Benefit)||||0.042
73963196|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Aided)||||0.19
73963197|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Aided)||||0.99
73963198|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Aided)||||0.24
73963199|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Aided)||||0.73
73963200|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Aided)||||0.39
73963201|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Unaided)||||0.24
73963202|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Unaided)||||0.81
73963203|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Unaided)||||0.34
73963204|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Unaided)||||0.038
73963205|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Unaided)||||0.53
73963206|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Benefit)||||0.63
73963207|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Benefit)||||0.83
73963208|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Benefit)||||0.71
73963209|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Benefit)||||0.16
73963210|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Benefit)||||0.81
73963211|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Aided)||||0.51
73963212|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Aided)||||0.47
73963213|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Aided)||||0.93
73963214|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Aided)||||0.62
73963215|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Aided)||||0.63
73963216|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Unaided)||||0.18
73963217|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Unaided)||||0.76
73963218|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Unaided)||||0.17
73963219|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Unaided)||||0.29
73963220|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Unaided)||||0.40
73963221|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Benefit)||||0.29
73963222|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Benefit)||||0.90
73963223|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Benefit)||||0.24
73963224|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Benefit)||||0.45
73930916|NCT00280566|147391707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.82||0.0162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0162
73930917|NCT00280566|147391707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|0.83||0.0003|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0003
73930918|NCT00280566|147391707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|0.98||0.0242|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0242
73930919|NCT00280566|147391707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.71||0.0161|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0161
73930920|NCT00280566|147391708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0088|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0088
73963225|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Benefit)||||0.37
73855410|NCT00487942|147257621|SUPERIORITY_OR_OTHER||Effect Size|0.15|||||TWO_SIDED|95.0|-0.61|0.9||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.90|-0.61|
74085012|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-5.7|2.9|||||Anxiety - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||2.9|-5.7|
73855411|NCT00487942|147257621|SUPERIORITY_OR_OTHER||Effect Size|0.25|||||TWO_SIDED|95.0|-0.5|1.01||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.50|
73855412|NCT00487942|147257621|SUPERIORITY_OR_OTHER||Effect Size|0.46|||||TWO_SIDED|95.0|-0.34|1.25||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.25|-0.34|
73855413|NCT00487942|147257622|SUPERIORITY_OR_OTHER||Effect Size|0.45|||||TWO_SIDED|95.0|-0.33|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.33|
73855414|NCT00487942|147257622|SUPERIORITY_OR_OTHER||Effect Size|0.34|||||TWO_SIDED|95.0|-0.42|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.42|
73855415|NCT00487942|147257622|SUPERIORITY_OR_OTHER||Effect Size|0.13|||||TWO_SIDED|95.0|-0.68|0.93||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.93|-0.68|
73855416|NCT00487942|147257623|SUPERIORITY_OR_OTHER||Effect Size|0.39|||||TWO_SIDED|95.0|-0.37|1.15||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.15|-0.37|
73963226|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Aided)||||0.84
73963227|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Aided)||||0.57
73963228|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Aided)||||0.71
73963229|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Aided)||||0.99
73963230|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Aided)||||0.78
73855417|NCT00487942|147257623|SUPERIORITY_OR_OTHER||Effect Size|-0.05|||||TWO_SIDED|95.0|-0.81|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.81|
73855418|NCT00487942|147257623|SUPERIORITY_OR_OTHER||Effect Size|-0.01|||||TWO_SIDED|95.0|-0.8|0.77||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.77|-0.80|
73855419|NCT00487942|147257624|SUPERIORITY_OR_OTHER||Effect Size|-0.99|||||TWO_SIDED|95.0|-1.79|-0.19||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||-0.19|-1.79|
73855420|NCT00487942|147257624|SUPERIORITY_OR_OTHER||Effect Size|-0.66|||||TWO_SIDED|95.0|-1.44|0.11||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.11|-1.44|
73855421|NCT00487942|147257624|SUPERIORITY_OR_OTHER||Effect Size|-0.03|||||TWO_SIDED|95.0|-0.82|0.75||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.75|-0.82|
73963231|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Unaided)||||0.50
73963232|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Unaided)||||0.48
73963233|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Unaided)||||0.64
73963234|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Unaided)||||0.041
73963235|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Unaided)||||0.89
73963236|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Benefit)||||0.14
73963237|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Benefit)||||0.48
73963238|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Benefit)||||0.23
73963239|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Benefit)||||0.57
73963240|NCT01796236|147461946|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Benefit)||||0.21
73963241|NCT01796236|147461947|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Sound Processor Usage: Week 6||||0.46
73963242|NCT01796236|147461947|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 12||||0.75
73963243|NCT01796236|147461947|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 24||||0.83
73963244|NCT01796236|147461947|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 12||||0.52
73963245|NCT01796236|147461947|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 24||||0.67
73963246|NCT01796236|147461947|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 36||||0.71
73963247|NCT01796236|147461949|SUPERIORITY_OR_OTHER|||||||0.91|||||||Mantel Haenszel|||Baseline: Smoking and Wet Snuff habits||||0.91
73963248|NCT01796236|147461949|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mantel Haenszel|||Week 3: Smoking and Wet Snuff habits||||0.70
73963249|NCT01796236|147461949|SUPERIORITY_OR_OTHER|||||||0.95|||||||Mantel Haenszel|||Week 12: Smoking and Wet Snuff habits||||0.95
73963250|NCT01796236|147461949|SUPERIORITY_OR_OTHER|||||||0.22|||||||Mantel Haenszel|||Month 12: Smoking and Wet Snuff habits||||0.22
73963251|NCT01796236|147461949|SUPERIORITY_OR_OTHER|||||||0.19|||||||Mantel Haenszel|||Month 24: Smoking and Wet Snuff habits||||0.19
73963252|NCT01796236|147461949|SUPERIORITY_OR_OTHER|||||||0.45|||||||Mantel Haenszel|||Month 36: Smoking and Wet Snuff habits||||0.45
73963253|NCT01796236|147461950|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.989|TWO_SIDED|95.0|||||Log Rank|||Loss of Implant (safety population)||||0.989
73963254|NCT00546754|147461952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0|||||ANOVA|||||||0.153
73963255|NCT00546754|147461953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343||95.0|||||ANOVA|||||||0.343
73963256|NCT00546754|147461954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0|||||Fisher Exact|||||||0.118
73963257|NCT00546754|147461955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.395||95.0|||||ANOVA|||||||0.395
73963258|NCT00546754|147461956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.662||95.0|||||Fisher Exact|||||||0.662
73963259|NCT00546754|147461957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Log Rank|||||||0.020
73963260|NCT00546754|147461958|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74025405|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean appetite change score from period 1 to period 3 between the two arms."|Difference in Change|-0.05||||0.88|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 3 between the two arms"||||0.88
74025406|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 3 between the two arms"||||0.93
74025407|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 3 between the two arms"||||0.93
74085013|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|-2.8|||||TWO_SIDED|95.0|-6.7|0.6|||||Depression - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||0.6|-6.7|
73963261|NCT00546754|147461959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.935||95.0|||||ANOVA|||||||0.935
73963262|NCT00546754|147461960|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
73963263|NCT00546754|147461961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.899||95.0|||||ANOVA|||||||0.899
73963264|NCT00546754|147461962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||95.0|||||ANOVA|||||||0.218
73963265|NCT00546754|147461963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||95.0|||||ANOVA|||||||0.386
73963266|NCT00546754|147461964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.725||95.0|||||ANOVA|||||||0.725
73963267|NCT02253537|147461973|EQUIVALENCE|2 x 2 contingency table with 95% CI.|2 x 2 contingency table|86.7|||||TWO_SIDED|95.0|62.1|96.3||||||||96.3|62.1|
73963268|NCT00390299|147461983|OTHER||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||TWO_SIDED|||||||||||||
73963269|NCT00390299|147461983|OTHER||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||TWO_SIDED|||||||||||||
73963270|NCT00390299|147461987|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.28|TWO_SIDED|95.0|0.67|4.11|||Log Rank|||||4.11|0.67|0.28
73963271|NCT01061671|147462007|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||negative binomial regression|Adjustments of confidence intervals for between-participant variation (overdispersion).||||||0.54
73963272|NCT01061671|147462008|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Log Rank|||||||0.34
73963273|NCT01061671|147462009|SUPERIORITY_OR_OTHER|||||||0.1461|TWO_SIDED||||||t-test, 2 sided|||||||.1461
73963274|NCT01849055|147462050|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|90.0|-4.98|2.54||||||SBP||2.54|-4.98|
73963275|NCT01849055|147462050|SUPERIORITY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|90.0|-4.7|2.53||||||SBP||2.53|-4.70|
73963276|NCT01849055|147462050|SUPERIORITY||Mean Difference (Final Values)|-1.54|||||TWO_SIDED|90.0|-5.3|2.22||||||SBP||2.22|-5.30|
73963277|NCT01849055|147462050|SUPERIORITY||Mean Difference (Final Values)|-1.53|||||TWO_SIDED|90.0|-5.16|2.1||||||SBP||2.10|-5.16|
73963278|NCT01849055|147462050|SUPERIORITY||Mean Difference (Final Values)|-3.84|||||TWO_SIDED|90.0|-7.74|0.07||||||SBP||0.07|-7.74|
73963279|NCT01849055|147462050|SUPERIORITY||Mean Difference (Final Values)|-0.38|||||TWO_SIDED|90.0|-2.95|2.18||||||DBP||2.18|-2.95|
73963280|NCT01849055|147462050|SUPERIORITY||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-3.69|1.48||||||DBP||1.48|-3.69|
73963281|NCT01849055|147462050|SUPERIORITY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|90.0|-3.75|1.85||||||DBP||1.85|-3.75|
73963282|NCT01849055|147462050|SUPERIORITY||Mean Difference (Final Values)|-1.49|||||TWO_SIDED|90.0|-4.09|1.1||||||DBP||1.10|-4.09|
73963283|NCT01849055|147462050|SUPERIORITY||Mean Difference (Final Values)|-2.51|||||TWO_SIDED|90.0|-5.23|0.2||||||DBP||0.20|-5.23|
73963284|NCT00475501|147462057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.9|STANDARD_DEVIATION|2.57|<|0.001|TWO_SIDED|95.0|7.86|18.0||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis||mean difference is for subjects reveiving testosterone (groups T and T/F) vs. subjects not receiving testosterone (F and Placebo)|The studies was powered for 1-RM strength based on a 1.18-alpha increase reported in the literature||18.0|7.86|<0.001
73963285|NCT00475501|147462058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|STANDARD_DEVIATION|0.311||0.015|TWO_SIDED|95.0|0.16|1.31||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered on grip strength. We employed 2x2 analysis to determine effects of testosterone, finasteride and interaction.||1.31|0.16|0.015
73855422|NCT00487942|147257625|SUPERIORITY_OR_OTHER||Effect Size|0.46|||||TWO_SIDED|95.0|-0.3|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.30|
73855423|NCT00487942|147257625|SUPERIORITY_OR_OTHER||Effect Size|0.08|||||TWO_SIDED|95.0|-0.68|0.83||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.68|
73855424|NCT00487942|147257625|SUPERIORITY_OR_OTHER||Effect Size|0.81|||||TWO_SIDED|95.0|0.0|1.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.63|-0.00|
73855425|NCT00487942|147257626|SUPERIORITY_OR_OTHER||Effect Size|-0.39|||||TWO_SIDED|95.0|-1.16|0.37||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.37|-1.16|
73855426|NCT00487942|147257626|SUPERIORITY_OR_OTHER||Effect Size|-0.45|||||TWO_SIDED|95.0|-1.21|0.31||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.31|-1.21|
73855427|NCT00487942|147257626|SUPERIORITY_OR_OTHER||Effect Size|-0.2|||||TWO_SIDED|95.0|-0.99|0.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.58|-0.99|
73855428|NCT00487942|147257627|SUPERIORITY_OR_OTHER||Effect Size|0.47|||||TWO_SIDED|95.0|-0.3|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.30|
73855429|NCT00487942|147257627|SUPERIORITY_OR_OTHER||Effect Size|0.28|||||TWO_SIDED|95.0|-0.48|1.04||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.04|-0.48|
73905453|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.25||||0.5196|TWO_SIDED|95.0|-1.02|0.52||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 0.25 hours||0.52|-1.02|0.5196
73905454|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.32||||0.3983|TWO_SIDED|95.0|-1.09|0.44||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change in VAS score from baseline at 0.5 hours||0.44|-1.09|0.3983
73930921|NCT00280566|147391708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.3677|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3677
73930922|NCT00280566|147391708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0734|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0734
74085014|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-4.1|2.6|||||Depression - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||2.6|-4.1|
73855430|NCT00487942|147257627|SUPERIORITY_OR_OTHER||Effect size|0.14|||||TWO_SIDED|95.0|-0.64|0.93||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.93|-0.64|
73855431|NCT00487942|147257628|SUPERIORITY_OR_OTHER||Effect size|-0.23|||||TWO_SIDED|95.0|-0.99|0.52||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.52|-0.99|
73855432|NCT00487942|147257628|SUPERIORITY_OR_OTHER||Effect size|0.34|||||TWO_SIDED|95.0|-0.42|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.42|
73855433|NCT00487942|147257628|SUPERIORITY_OR_OTHER||Effect size|0.06|||||TWO_SIDED|95.0|-0.72|0.85||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.85|-0.72|
73855434|NCT00487942|147257629|SUPERIORITY_OR_OTHER||Effect size|-0.2|||||TWO_SIDED|95.0|-0.95|0.56||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.56|-0.95|
73855435|NCT00487942|147257629|SUPERIORITY_OR_OTHER||Effect size|-0.35|||||TWO_SIDED|95.0|-1.11|0.41||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.41|-1.11|
73855436|NCT00487942|147257629|SUPERIORITY_OR_OTHER||Effect size|-0.16|||||TWO_SIDED|95.0|-0.95|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.95|
73855437|NCT00487942|147257630|SUPERIORITY_OR_OTHER||Effect size|-0.51|||||TWO_SIDED|95.0|-1.3|0.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.27|-1.30|
73905455|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.26||||0.489|TWO_SIDED|95.0|-1.03|0.5||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 0.75 hours||0.5|-1.03|0.4890
73905456|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.21||||0.5903|TWO_SIDED|95.0|-0.97|0.56||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 1 hour||0.56|-0.97|0.5903
73905457|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.13||||0.7352|TWO_SIDED|95.0|-0.9|0.64||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 1.5 hours||0.64|-0.90|0.7352
73905458|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.6892|TWO_SIDED|95.0|-0.92|0.61||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 2 hours||0.61|-0.92|0.6892
73905459|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.01||||0.9767|TWO_SIDED|95.0|-0.78|0.76||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 2.5 hours||0.76|-0.78|0.9767
73905460|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Median Difference (Net)|0.32||||0.3964|TWO_SIDED|95.0|-0.44|1.09||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 3 hours||1.09|-0.44|0.3964
73905461|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|0.22||||0.5669|TWO_SIDED|95.0|-0.55|0.98||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 3.5 hours||0.98|-0.55|0.5669
73905462|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.7006|TWO_SIDED|95.0|-0.91|0.62||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 4 hours||0.62|-0.91|0.7006
73905463|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.1||||0.794|TWO_SIDED|95.0|-0.87|0.67||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 5 hours||0.67|-0.87|0.7940
74085015|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-5.4|1.4|||||Depression - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||1.4|-5.4|
74085016|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-4.5|4.9|||||Satisfaction with Social Role - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||4.9|-4.5|
73930923|NCT00280566|147391708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9166|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9166
74085017|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-1.8|7.7|||||Satisfaction with Social Role - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||7.7|-1.8|
73930924|NCT00280566|147391708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2791|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2791
73930925|NCT00280566|147391708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.146|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1460
73930926|NCT00280566|147391708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.7301|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7301
73930927|NCT00280566|147391708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8162
73905464|NCT05298306|147341721|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.6892|TWO_SIDED|95.0|-0.92|0.61|||Mixed Models Analysis|No adjustment for multiple comparisons was made due to the exploratory nature of the study.||Change from baseline VAS score at 6 hours|Difference is LAT8881 minus placebo.|0.61|-0.92|0.6892
73905465|NCT01178073|147341742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.502||||0.0002|TWO_SIDED|95.0|0.348|0.724|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.724|0.348|0.0002
73905466|NCT01178073|147341742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.477||||0.0004|TWO_SIDED|95.0|0.314|0.723|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.|||0.723|0.314|0.0004
73905467|NCT01178073|147341742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528||||0.0045|TWO_SIDED|95.0|0.338|0.827|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.|||0.827|0.338|0.0045
73905468|NCT01178073|147341743|SUPERIORITY_OR_OTHER||Mean Percent Difference|-33.81|||<|0.0001|TWO_SIDED|95.0|-44.78|-20.66|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||-20.66|-44.78|<0.0001
73905469|NCT01178073|147341743|SUPERIORITY_OR_OTHER||Mean Percent Difference|-25.09||||0.0111|TWO_SIDED|95.0|-40.04|-6.4|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||-6.40|-40.04|0.0111
73905470|NCT01178073|147341743|SUPERIORITY_OR_OTHER||Mean Percent Difference|-41.51|||<|0.0001|TWO_SIDED|95.0|-53.16|-26.97|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||-26.97|-53.16|<0.0001
73905471|NCT01178073|147341744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.563||||0.0264|TWO_SIDED|95.0|1.054|2.319|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.|||2.319|1.054|0.0264
73905472|NCT01178073|147341744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.424||||0.1518|TWO_SIDED|95.0|0.878|2.308|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.|||2.308|0.878|0.1518
73905473|NCT01178073|147341744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.723||||0.0321|TWO_SIDED|95.0|1.047|2.833|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.|||2.833|1.047|0.0321
73905474|NCT01178073|147341745|SUPERIORITY_OR_OTHER||Median Difference|22.75|||<|0.0001|TWO_SIDED|95.0|12.0|33.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||33.50|12.00|<0.0001
73905475|NCT01178073|147341745|SUPERIORITY_OR_OTHER||Median Difference|24.75||||0.0005|TWO_SIDED|95.0|11.0|38.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||38.50|11.00|0.0005
73905476|NCT01178073|147341745|SUPERIORITY_OR_OTHER||Median Difference|20.85||||0.003|TWO_SIDED|95.0|8.0|33.7|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||33.70|8.00|0.0030
73905477|NCT01178073|147341746|SUPERIORITY_OR_OTHER||Median Difference|0.0||||0.2287|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.0|0.0|0.2287
73905478|NCT01178073|147341746|SUPERIORITY_OR_OTHER||Median Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test|This comparison was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||0.0|0.0|
73905479|NCT01178073|147341746|SUPERIORITY_OR_OTHER||Median Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test|This comparison was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||0.0|0.0|
73963286|NCT00475501|147462059|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.19|STANDARD_DEVIATION|1.142|<|0.001|TWO_SIDED|95.0|1.95|6.43||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered on lumbar spine bone mineral density. We employed a 2x2 analysis for effects ot testosterone, finasteride and interaction||6.43|1.95|<0.001
73905480|NCT01178073|147341747|SUPERIORITY_OR_OTHER||Median Difference|-0.38|||||TWO_SIDED|95.0|-0.75|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.00|-0.75|
73905481|NCT01178073|147341747|SUPERIORITY_OR_OTHER||Median Difference|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||0.00|-1.00|
73905482|NCT01178073|147341747|SUPERIORITY_OR_OTHER||Median Difference|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||0.00|-1.00|
73905483|NCT01352468|147341748|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|Controlling for baseline scores||||||.35
73905484|NCT01352468|147341749|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|Controlling for baseline scores||||||.68
73905485|NCT01352468|147341750|SUPERIORITY_OR_OTHER|||||||0.57|||||||ANCOVA|Controlling for baseline scores||||||.57
73905486|NCT03496571|147341798|SUPERIORITY||LSM Difference from Placebo|-95.0|||<|0.001|TWO_SIDED|95.0|-122.0|-68.0|||ANCOVA|||||-68|-122|<0.001
73905487|NCT03496571|147341798|SUPERIORITY||LSM Difference from Placebo|-102.0|||<|0.001|TWO_SIDED|95.0|-128.0|-76.0|||ANCOVA|||||-76|-128|<0.001
74025408|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.94|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 3 between the two arms"||||0.94
73855438|NCT00487942|147257630|SUPERIORITY_OR_OTHER||Effect size|0.55|||||TWO_SIDED|95.0|-0.25|1.35||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.35|-0.25|
73855439|NCT00487942|147257630|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.78|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.78|
73855440|NCT00487942|147257631|SUPERIORITY_OR_OTHER||Effect size|-0.64|||||TWO_SIDED|95.0|-1.43|0.15||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.15|-1.43|
73855441|NCT00487942|147257631|SUPERIORITY_OR_OTHER||Effect Size|-0.26|||||TWO_SIDED|95.0|-1.05|0.53||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.53|-1.05|
73855442|NCT00487942|147257631|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.9|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.90|
73855443|NCT00487942|147257632|SUPERIORITY_OR_OTHER||Effect size|-0.15|||||TWO_SIDED|95.0|-0.92|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.92|
73855444|NCT00487942|147257632|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.54|1.04||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.04|-0.54|
73905488|NCT03496571|147341798|SUPERIORITY||LSM Difference from Placebo|-98.0|||<|0.001|TWO_SIDED|95.0|-121.0|-76.0|||ANCOVA|||||-76|-121|<0.001
73905489|NCT03496571|147341799|SUPERIORITY||Percent Difference from Placebo|55.0|||<|0.001|TWO_SIDED|95.0|27.0|76.0|||Fisher Exact|||||76|27|<0.001
74025409|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 3 between the two arms."|Difference in Change|0.004||||0.97|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 3 between the two arms"||||0.97
73855445|NCT00487942|147257632|SUPERIORITY_OR_OTHER||Effect size|-0.31|||||TWO_SIDED|95.0|-1.12|0.49||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.49|-1.12|
73905490|NCT03496571|147341799|SUPERIORITY||Percent Difference from Placebo|62.0|||<|0.001|TWO_SIDED|95.0|34.0|82.0|||Fisher Exact|||||82|34|<0.001
73905491|NCT03496571|147341799|SUPERIORITY||Percent Difference from Placebo|58.0|||<|0.001|TWO_SIDED|95.0|36.0|74.0|||Fisher Exact|||||74|36|<0.001
73905492|NCT03496571|147341800|SUPERIORITY||LSM Difference from Placebo|-20.0||||0.05|TWO_SIDED|95.0|-40.0|0.0|||ANCOVA|||||0|-40|0.05
73905493|NCT03496571|147341800|SUPERIORITY||LSM Difference from Placebo|-33.0||||0.002|TWO_SIDED|95.0|-53.0|-13.0|||ANCOVA|||||-13|-53|0.002
73905494|NCT03496571|147341800|SUPERIORITY||LSM Difference from Placebo|-26.0||||0.004|TWO_SIDED|95.0|-44.0|-9.0|||ANCOVA|||||-9|-44|0.004
73963287|NCT00475501|147462060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.737|STANDARD_ERROR_OF_MEAN|0.343||0.037|TWO_SIDED|95.0|-1.41|-0.064||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study is was not powered for score on Geriatric Depression Scale||-0.064|-1.41|0.037
73963288|NCT00475501|147462061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.871|STANDARD_ERROR_OF_MEAN|1.108||0.012|TWO_SIDED|95.0|0.699|5.04||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for 30-minute recall on Rey figure test||5.04|0.699|0.012
73963289|NCT00475501|147462062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.642|STANDARD_ERROR_OF_MEAN|2.272||0.779|TWO_SIDED|95.0|-5.095|3.811||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Trials A test||3.811|-5.095|0.779
73963290|NCT00475501|147462063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.587|STANDARD_ERROR_OF_MEAN|0.743||0.433|TWO_SIDED|95.0|-0.869|2.043||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Benton test||2.043|-0.869|0.433
73963291|NCT00475501|147462064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.13|STANDARD_DEVIATION|0.54|<|0.001|TWO_SIDED|95.0|3.07|5.18||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||This study was powered for hematocrit based on literature report that testosterone \> 2 alpha increase in hematocrit||5.18|3.07|<0.001
73963292|NCT00475501|147462065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1419|STANDARD_ERROR_OF_MEAN|0.2529||0.6219|TWO_SIDED|95.0|-0.353|6.37||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for dietary protein intake||6.37|-0.353|0.6219
73855446|NCT00487942|147257633|SUPERIORITY_OR_OTHER||Effect size|-0.44|||||TWO_SIDED|95.0|-1.22|0.33||Inferential statistics not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.33|-1.22|
73855447|NCT00487942|147257633|SUPERIORITY_OR_OTHER||Effect size|-0.89|||||TWO_SIDED|95.0|-1.69|-0.08||Inferential statistics not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||-0.08|-1.69|
73855448|NCT00487942|147257633|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.95|0.7||Inferential statistics not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.95|
73855449|NCT00487942|147257679|SUPERIORITY_OR_OTHER||Effect size|0.12|||||TWO_SIDED|95.0|-0.76|1.0||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.0|-0.76|
73855450|NCT00487942|147257679|SUPERIORITY_OR_OTHER||Effect size|-0.33|||||TWO_SIDED|95.0|-1.15|0.48||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.48|-1.15|
73855451|NCT00487942|147257679|SUPERIORITY_OR_OTHER||Effect size|0.27|||||TWO_SIDED|95.0|-0.61|1.15||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.15|-0.61|
73855452|NCT00487942|147257680|SUPERIORITY_OR_OTHER||Effect size|0.33|||||TWO_SIDED|95.0|-0.58|1.24||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.24|-0.58|
73963293|NCT00475501|147462066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.33|STANDARD_DEVIATION|1.83||0.0051|TWO_SIDED|95.0|1.73|8.94||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was powered for prostate volume based on a literature report that testosterone increases prostate volume 1.85 alpha per year. We employed a 2x2 analysis for effects of testosterone, finasteride and interaction.||8.94|1.73|0.0051
73855453|NCT00487942|147257680|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.91|0.81||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.81|-0.91|
73855454|NCT00487942|147257680|SUPERIORITY_OR_OTHER||Effect size|-0.44|||||TWO_SIDED|95.0|-1.33|0.45||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.45|-1.33|
73855455|NCT00487942|147257681|SUPERIORITY_OR_OTHER||Effect size|0.18|||||TWO_SIDED|95.0|-0.75|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.75|
73855456|NCT00487942|147257681|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.98|0.78||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.78|-0.98|
73855457|NCT00487942|147257681|SUPERIORITY_OR_OTHER||Effect size|0.37|||||TWO_SIDED|95.0|-0.54|1.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.27|-0.54|
73855458|NCT00487942|147257682|SUPERIORITY_OR_OTHER||Effect size|-0.38|||||TWO_SIDED|95.0|-1.14|0.38||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.38|-1.14|
73855459|NCT00487942|147257682|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.89|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.89|
73855460|NCT00487942|147257682|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.84|0.73||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.84|
73855461|NCT00487942|147257683|SUPERIORITY_OR_OTHER||Effect size|-0.41|||||TWO_SIDED|95.0|-1.21|0.4||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.40|-1.21|
73855462|NCT00487942|147257683|SUPERIORITY_OR_OTHER||Effect size|-0.29|||||TWO_SIDED|95.0|-1.09|0.52||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.52|-1.09|
73855463|NCT00487942|147257683|SUPERIORITY_OR_OTHER||Effect size|-0.69|||||TWO_SIDED|95.0|-1.51|0.14||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.14|-1.51|
73905495|NCT01226043|147341815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|2.15|2.44|||ANOVA|The last observation carried forward (LOCF) method was applied to impute missing Week 4 overall patient preference values for ANOVA analysis.||The hypothesis was to determine whether patients have higher preference score for Lantus® SoloSTAR® pen compared to Lantus® vial/syringe. Differences of patient preference score greater than 0.5 were considered clinically meaningful. The power for detecting a true difference of 0.5 considering a standard deviation from 1.6 to 2.5, assuming 130 evaluable patients per arm and a two-sided test at 0.05 significance level ranged from 89% to more than 99%.||2.44|2.15|<0.0001
73905496|NCT00910988|147341829|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||This p-value corresponds to the two way interaction between time and order and is not adjusted for multiple comparisons. The a priori threshold for statistical significance is alpha equal to 0.05. There was no 3 way interaction.|ANCOVA|Repeated measures ANCOVA with time as the repeated measure, drug assignment as a fixed factor, and order as a fixed factor.||The hypothesis being tested is whether there is a significant effect of one or both antipsychotics on whole body insulin sensitivity. Sample size was calculated using power calculations to detect significant effects of treatment on insulin sensitivity. Drug assignment is a 2-level fixed factor (olanzapine vs ziprasidone) as is order (drug first vs placebo first). Baseline of the dependent variable as well as baseline DEXA total fat were entered into the model as covariates.||||0.001
73905497|NCT00910988|147341832|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0||||This p-value corresponds to the 3 way interaction between time, drug (olanzapine vs ziprasidone), and order (drug first vs placebo first) and is not adjusted for multiple comparisons.|ANCOVA|||The null hypothesis is that olanzapine and ziprasidone would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue, which was measured by evaluating the rate of appearance of labeled glycerol. The alternative hypothesis is that olanzapine, but not ziprasidone, would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue.||||0.57
73905498|NCT00191646|147341890|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||Log Rank|||Using a two-sided log-rank test with a Type I error of 0.05, 636 events for PFS out of the 919 patients would give an 80% statistical power under the alternative hypothesis that the hazard ratio of the G/C arm versus the P/C arm was 0.08.||||0.199
73905499|NCT00191646|147341891|SUPERIORITY_OR_OTHER|||||||0.771||95.0|||||Fisher Exact|||||||0.771
73905500|NCT00191646|147341891|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||Fisher Exact|||||||0.784
73905501|NCT00191646|147341892|SUPERIORITY_OR_OTHER|||||||0.621||95.0|||||Log Rank|||||||0.621
73905502|NCT00191646|147341893|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Log Rank|||||||0.013
73905503|NCT03911843|147341926|SUPERIORITY||Mean Difference (Net)|-0.14|||<|0.05|TWO_SIDED|95.0||||the p-value of significance was calculated using the analysis system|Wilcoxon (Mann-Whitney)|||||||<0.05
73905504|NCT03911843|147341926|SUPERIORITY||Mean Difference (Net)|-0.14|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
73905505|NCT03911843|147341927|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73905506|NCT03911843|147341928|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
73905507|NCT01907100|147341929|OTHER||Hazard Ratio (HR)|0.555||||0.0174|TWO_SIDED|95.0|0.34|0.907|||Proportional hazards mode||Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II Part||0.907|0.340|0.0174
73905508|NCT01907100|147341929|OTHER||Hazard Ratio (HR)|1.01||||0.543|TWO_SIDED|95.0|0.79|1.3||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.|"Phase III part:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."||1.30|0.79|0.5430
73905509|NCT01907100|147341930|OTHER||Hazard Ratio (HR)|0.782||||0.4132|TWO_SIDED|95.0|0.433|1.412|||Proportional hazards mode||Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II||1.412|0.433|0.4132
73905510|NCT01907100|147341930|OTHER||Hazard Ratio (HR)|1.12||||0.7306|TWO_SIDED|95.0|0.79|1.58||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.|"Phase III:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."||1.58|0.79|0.7306
73963294|NCT00475501|147462067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.868|STANDARD_ERROR_OF_MEAN|0.668||0.196|TWO_SIDED|95.0|-3.434|1.698||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Lif Satisfaction A test||1.698|-3.434|0.196
73963295|NCT03312907|147462144|OTHER||Odds Ratio (OR)|1.27||||0.5342|TWO_SIDED|95.0|0.6|2.71|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose. Belimumab + Standard therapy arm was excluded from model.|||2.71|0.60|0.5342
73963296|NCT03312907|147462144|OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.32|1.54|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, and Baseline prednisone equivalent dose. Belimumab + Placebo arm excluded from model.|||1.54|0.32|
73905511|NCT01907100|147341931|OTHER||Odds Ratio (OR)|1.09||||0.3189|TWO_SIDED|95.0|0.76|1.58||one-sided p-value|Regression, Logistic|Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.||Exact 95% CI by Clopper and Pearson.|1.58|0.76|0.3189
73905512|NCT01907100|147341932|OTHER||Odds Ratio (OR)|0.79||||0.7512|TWO_SIDED|95.0|0.4|1.55||one-sided p-value|Regression, Logistic|Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.|||1.55|0.40|0.7512
73963297|NCT03312907|147462145|OTHER||Odds Ratio (OR)|1.12||||0.8582|TWO_SIDED|95.0|0.33|3.78|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||3.78|0.33|0.8582
74025410|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean fatigue score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 3 between the two arms"||||0.95
73855464|NCT00487942|147257684|SUPERIORITY_OR_OTHER||Effect size|-0.24|||||TWO_SIDED|95.0|-1.06|0.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.58|-1.06|
73855465|NCT00487942|147257684|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.85|0.75||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.75|-0.85|
73855466|NCT00487942|147257684|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.9|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.90|
73855467|NCT00487942|147257687|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.8|0.71||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.71|-0.80|
73855468|NCT00487942|147257687|SUPERIORITY_OR_OTHER||Effect size|-0.31|||||TWO_SIDED|95.0|-1.06|0.45||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.45|-1.06|
73855469|NCT00487942|147257687|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.68|0.89||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.89|-0.68|
73855470|NCT00487942|147257688|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.88|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.88|
73855471|NCT00487942|147257688|SUPERIORITY_OR_OTHER||Effect size|0.05|||||TWO_SIDED|95.0|-0.72|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.72|
73855472|NCT00487942|147257688|SUPERIORITY_OR_OTHER||Effect size|0.0|||||TWO_SIDED|95.0|-0.8|0.81||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.81|-0.80|
73855473|NCT00487942|147257689|SUPERIORITY_OR_OTHER||Effect size|-0.62|||||TWO_SIDED|95.0|-1.44|0.2||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.20|-1.44|
73855474|NCT00487942|147257689|SUPERIORITY_OR_OTHER||Effect size|-0.18|||||TWO_SIDED|95.0|-0.98|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.98|
73905513|NCT02103218|147341939|SUPERIORITY|||||||0.62|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.62
73905514|NCT02103218|147341940|SUPERIORITY|||||||0.15|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.15
73905515|NCT02103218|147341941|SUPERIORITY|||||||0.47|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.47
73905516|NCT02103218|147341942|SUPERIORITY|||||||0.29|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.29
73905517|NCT02103218|147341943|SUPERIORITY||||||<|0.001|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||<0.001
73905518|NCT02103218|147341944|SUPERIORITY|||||||0.02||||||Omnibus overall test for any group x time interaction was p = 0.77.|linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.02
73905519|NCT02103218|147341945|SUPERIORITY|||||||0.67|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.67
73905520|NCT02103218|147341946|SUPERIORITY|||||||0.45|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.45
73905521|NCT02103218|147341947|SUPERIORITY|||||||0.7|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.70
73905522|NCT02103218|147341948|SUPERIORITY|||||||0.42|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.42
73905523|NCT02103218|147341949|SUPERIORITY|||||||0.63|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.63
73905524|NCT02103218|147341950|SUPERIORITY|||||||0.05||||||Omnibus overall test for any group x time interaction was p = 0.78.|count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.05
73905525|NCT02103218|147341951|SUPERIORITY|||||||0.5|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.50
73905526|NCT02103218|147341953|SUPERIORITY|||||||0.86|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.86
73963298|NCT03312907|147462145|OTHER||Odds Ratio (OR)|0.53|||||TWO_SIDED|95.0|0.17|1.7|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from model.|||1.70|0.17|
73963299|NCT03312907|147462146|OTHER||Odds Ratio (OR)|1.64||||0.3613|TWO_SIDED|95.0|0.57|4.72|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||4.72|0.57|0.3613
73963300|NCT03312907|147462146|OTHER||Odds Ratio (OR)|0.45|||||TWO_SIDED|95.0|0.19|1.09|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||1.09|0.19|
73963301|NCT03312907|147462152|OTHER||Hazard Ratio (HR)|0.81||||0.215|TWO_SIDED|95.0|0.57|1.13|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||1.13|0.57|0.2150
73963302|NCT03312907|147462152|OTHER||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|1.03|2.63|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||2.63|1.03|
73963303|NCT03312907|147462153|OTHER||Hazard Ratio (HR)|0.87||||0.3757|TWO_SIDED|95.0|0.64|1.19|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||1.19|0.64|0.3757
73963304|NCT03312907|147462153|OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.71|1.49|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||1.49|0.71|
73963305|NCT03312907|147462154|OTHER||Hazard Ratio (HR)|1.55||||0.5127|TWO_SIDED|95.0|0.42|5.78|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||5.78|0.42|0.5127
73963306|NCT03312907|147462154|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.23|2.1|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||2.10|0.23|
73963307|NCT03312907|147462155|OTHER||Hazard Ratio (HR)|0.83||||0.8436|TWO_SIDED|95.0|0.14|5.05|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||5.05|0.14|0.8436
74025411|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean anxiety score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 3 between the two arms"||||0.95
73963308|NCT03312907|147462155|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.09|3.14|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||3.14|0.09|
73963309|NCT03312907|147462162|OTHER||Odds Ratio (OR)|1.55||||0.7102|TWO_SIDED|95.0|0.15|15.7|||Regression, Logistic|Week 52|Odds ratio at Week 52 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab+ Standard therapy arm was excluded from the model.|||15.70|0.15|0.7102
73963310|NCT03312907|147462162|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.1|10.71|||||Odds ratio at Week 52 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from the model.|||10.71|0.10|
73963311|NCT03312907|147462162|OTHER||Odds Ratio (OR)|0.9||||0.8641|TWO_SIDED|95.0|0.26|3.15|||Regression, Logistic|Week 104|Odds ratio at Week 104 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from the model.|||3.15|0.26|0.8641
73963312|NCT03312907|147462162|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.26|5.64|||||Odds ratio at Week 104 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from the model.|||5.64|0.26|
73963313|NCT03112174|147462191|SUPERIORITY||Hazard Ratio (HR)|0.629||||0.0024|TWO_SIDED|95.0|0.465|0.85||P value is from stratified log-rank test.|Log Rank|||||0.850|0.465|0.0024
73963314|NCT03112174|147462197|SUPERIORITY||Rate Ratio|1.658||||0.0004|TWO_SIDED|95.0|1.24|2.218||Estimate and p-value for rate ratio are based on Cochran-Mantel-Haenszel (CMH) test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.|Cochran-Mantel-Haenszel||For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.|||2.218|1.240|0.0004
74025412|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean constipation score from period 1 to period 3 between the two arms."|Difference in Change|0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 3 between the two arms"||||0.93
73855475|NCT00487942|147257689|SUPERIORITY_OR_OTHER||Effect size|-0.17|||||TWO_SIDED|95.0|-0.97|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.97|
73855476|NCT00487942|147257690|SUPERIORITY_OR_OTHER||Effect size|-0.08|||||TWO_SIDED|95.0|-0.88|0.72||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.72|-0.88|
73855477|NCT00487942|147257690|SUPERIORITY_OR_OTHER||Effect size|-0.08|||||TWO_SIDED|95.0|-0.88|0.72||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.72|-0.88|
73855478|NCT00487942|147257690|SUPERIORITY_OR_OTHER||Effect size|0.08|||||TWO_SIDED|95.0|-0.72|0.89||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.89|-0.72|
73855479|NCT00487942|147257691|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.65|0.87||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.65|
73855480|NCT00487942|147257691|SUPERIORITY_OR_OTHER||Effect size|0.13|||||TWO_SIDED|95.0|-0.63|0.88||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.88|-0.63|
73905527|NCT02103218|147341954|SUPERIORITY|||||||0.46|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.46
73905528|NCT02103218|147341955|SUPERIORITY|||||||0.7|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.70
73905529|NCT02103218|147341956|SUPERIORITY|||||||0.29|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.29
73905530|NCT02103218|147341957|SUPERIORITY|||||||0.43|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.43
73905531|NCT00644228|147341963|SUPERIORITY||Hazard Ratio (HR)|0.712||||0.0018|TWO_SIDED|96.0|0.56|0.906||The p-value is from a one-sided, stratified log-rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|With four years of patient accrual and two and a half years of follow-up, 220 patients per arm yields 87% power to detect an increase of PFS of 50%, from a median of 3 years to 4.5 years, which corresponds to a hazard ratio of 1.5. These calculations are based on a one-sided stratified log-rank test at level 0.025 with two interim analyses. The final analysis will be carried out at the 0.02 significance level to allow for two interim analyses at the 0.0025 significance level.||0.906|0.560|0.0018
73905532|NCT00644228|147341964|SUPERIORITY||Hazard Ratio (HR)|0.709||||0.025|TWO_SIDED|95.0|0.524|0.959||The p-value is based on a two-sided, stratified log rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|Overall survival will be compared between the two treatment arms using a stratified log-rank test.||0.959|0.524|0.0250
73963315|NCT03112174|147462198|SUPERIORITY||Rate Ratio|1.101||||0.1279|TWO_SIDED|95.0|0.973|1.247||Estimate and p-value for rate ratio are based on CMH test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.|Cochran-Mantel-Haenszel||For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.|||1.247|0.973|0.1279
73963316|NCT03112174|147462199|SUPERIORITY|||||||0.2028|||||||Fisher Exact|||Bone marrow aspirate||||0.2028
73963317|NCT03112174|147462199|SUPERIORITY|||||||0.0014|||||||Fisher Exact|||Peripheral blood||||0.0014
73963318|NCT03112174|147462200|SUPERIORITY||Hazard Ratio (HR)|0.832||||0.2669|TWO_SIDED|95.0|0.602|1.151||P value is from stratified log-rank test.|Log Rank||Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.|||1.151|0.602|0.2669
73963319|NCT03112174|147462202|SUPERIORITY||Hazard Ratio (HR)|0.541||||0.0013|TWO_SIDED|95.0|0.369|0.792||P value is from stratified log-rank test.|Log Rank||Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.|||0.792|0.369|0.0013
73963320|NCT03112174|147462217|SUPERIORITY||Hazard Ratio (HR)|1.169||||0.2861|TWO_SIDED|95.0|0.879|1.554||P value is from stratified log-rank test.|Log Rank|||||1.554|0.879|0.2861
73963321|NCT01534494|147462245|OTHER|Paired t-test||||||0.008|||||||t-test, 2 sided|Paired t-test for significance of change. t(8) = 3.477. P(2-sided) = 0.008||Single-group pre-post contrast||||0.008
73963322|NCT02374463|147462309|SUPERIORITY||||||<|0.05||||||P value not adjusted for multiple comparisons|t-test, 2 sided|||within group change was assessed||||<0.05
73963323|NCT02374463|147462310|SUPERIORITY||||||=|0.08||||||p value not adjusted for multiple comparisons|ANOVA|||||||=0.08
73855481|NCT00487942|147257691|SUPERIORITY_OR_OTHER||Effect size|1.69|||||TWO_SIDED|95.0|0.78|2.6||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||2.60|0.78|
73855482|NCT00487942|147257692|SUPERIORITY_OR_OTHER||Effect size|-0.3|||||TWO_SIDED|95.0|-1.06|0.46||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.46|-1.06|
73855483|NCT00487942|147257692|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.87|0.67||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.67|-0.87|
73855484|NCT00487942|147257692|SUPERIORITY_OR_OTHER||Effect size|0.89|||||TWO_SIDED|95.0|0.05|1.74||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.74|0.05|
73855485|NCT00487942|147257693|SUPERIORITY_OR_OTHER||Effect size|-0.25|||||TWO_SIDED|95.0|-1.05|0.55||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.55|-1.05|
73855486|NCT00487942|147257693|SUPERIORITY_OR_OTHER||Effect size|0.29|||||TWO_SIDED|95.0|-0.52|1.09||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.09|-0.52|
73855487|NCT00487942|147257693|SUPERIORITY_OR_OTHER||Effect size|0.75|||||TWO_SIDED|95.0|-0.08|1.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.58|-0.08|
73963324|NCT02374463|147462311|SUPERIORITY||||||=|0.6|||||||ANOVA|not adjusted for multiple comparisons||||||=0.6
73963325|NCT02374463|147462312|SUPERIORITY|||||||0.84||||||Not adjusted for multiple comparisons|Chi-squared|exploratory aim prespecified.||||||0.84
73963326|NCT02374463|147462312|SUPERIORITY||||||=|0.4|||||||Chi-squared|||||||=0.4
73963327|NCT02374463|147462313|SUPERIORITY||||||=|0.3||||||not adjusted for multiple comparisons|ANOVA|||||||=0.3
73963328|NCT02374463|147462314|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73963329|NCT04723394|147462340|SUPERIORITY||Relative Risk Reduction (100*[1-RR])|50.38||||0.01|TWO_SIDED|95.0|14.38|71.25|||Cochran-Mantel-Haenszel|CMH was stratified by randomization factors||AZD7442 vs Placebo||71.25|14.38|0.010
73963330|NCT04723394|147462341|SUPERIORITY||Relative Risk Reduction (100*[1-RR])|49.24||||0.009|TWO_SIDED|95.0|14.72|69.79|||Cochran-Mantel-Haenszel|CMH was stratified by randomization factors||AZD7442 vs Placebo||69.79|14.72|0.009
73855488|NCT00487942|147257694|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.78|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.78|
73855489|NCT00487942|147257694|SUPERIORITY_OR_OTHER||Effect size|0.55|||||TWO_SIDED|95.0|-0.27|1.36||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.36|-0.27|
73855490|NCT00487942|147257694|SUPERIORITY_OR_OTHER||Effect size|1.62|||||TWO_SIDED|95.0|0.7|2.55||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||2.55|0.70|
73855491|NCT00487942|147257695|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.64|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.64|
73855492|NCT00487942|147257695|SUPERIORITY_OR_OTHER||Effect size|-0.11|||||TWO_SIDED|95.0|-0.87|0.64||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.64|-0.87|
73855493|NCT00487942|147257695|SUPERIORITY_OR_OTHER||Effect size|0.73|||||TWO_SIDED|95.0|-0.08|1.54||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.54|-0.08|
73855494|NCT00487942|147257696|SUPERIORITY_OR_OTHER||Effect size|-0.5|||||TWO_SIDED|95.0|-1.27|0.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.27|-1.27|
73855495|NCT00487942|147257696|SUPERIORITY_OR_OTHER||Effect size|-0.28|||||TWO_SIDED|95.0|-1.05|0.5||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.50|-1.05|
73855496|NCT00487942|147257696|SUPERIORITY_OR_OTHER||Effect size|0.3|||||TWO_SIDED|95.0|-0.51|1.11||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.11|-0.51|
73905533|NCT00644228|147341965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||The p-value is based on a stratified Cochran-Mantel-Haenszel test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Cochran-Mantel-Haenszel|||||||0.20
73905534|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.68|||||TWO_SIDED|95.0|0.48|0.94|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 4||0.94|0.48|
73905535|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.81|||||TWO_SIDED|95.0|0.64|1.04|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 6B||1.04|0.64|
73905536|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.74|1.23|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 9V||1.23|0.74|
73905537|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.67|||||TWO_SIDED|95.0|0.45|1.01|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 14||1.01|0.45|
73963331|NCT00774397|147462343|SUPERIORITY_OR_OTHER|||||||0.0537||95.0||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||0.0537
73855497|NCT00487942|147257697|SUPERIORITY_OR_OTHER||Effect size|-0.12|||||TWO_SIDED|95.0|-0.92|0.68||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.68|-0.92|
73855498|NCT00487942|147257697|SUPERIORITY_OR_OTHER||Effect size|0.07|||||TWO_SIDED|95.0|-0.73|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.73|
73855499|NCT00487942|147257697|SUPERIORITY_OR_OTHER||Effect size|0.03|||||TWO_SIDED|95.0|-0.77|0.83||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.77|
73855500|NCT00487942|147257698|SUPERIORITY_OR_OTHER||Effect size|0.0|||||TWO_SIDED|95.0|-0.8|0.8||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.80|-0.80|
73855501|NCT00487942|147257698|SUPERIORITY_OR_OTHER||Effect size|0.18|||||TWO_SIDED|95.0|-0.62|0.98||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.98|-0.62|
73855502|NCT00487942|147257698|SUPERIORITY_OR_OTHER||Effect size|0.66|||||TWO_SIDED|95.0|-0.16|1.49||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.49|-0.16|
73905538|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.96|||||TWO_SIDED|95.0|0.7|1.31|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 18C||1.31|0.70|
73905539|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.56|||||TWO_SIDED|95.0|0.4|0.77|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 19F||0.77|0.40|
73905540|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.64|1.05|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 23F||1.05|0.64|
73905541|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|1.97|||||TWO_SIDED|95.0|1.39|2.8|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 4||2.80|1.39|
73905542|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|3.04|||||TWO_SIDED|95.0|2.41|3.84|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 6B||3.84|2.41|
73905543|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|1.26|||||TWO_SIDED|95.0|0.98|1.62|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 9V||1.62|0.98|
73905544|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|6.66|||||TWO_SIDED|95.0|4.53|9.79|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 14||9.79|4.53|
73905545|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|2.34|||||TWO_SIDED|95.0|1.68|3.24|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 18C||3.24|1.68|
73905546|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|4.47|||||TWO_SIDED|95.0|3.29|6.07|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 19F||6.07|3.29|
73905547|NCT01298544|147341980|SUPERIORITY_OR_OTHER||Ratio of GMCs|2.08|||||TWO_SIDED|95.0|1.65|2.63|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 23F||2.63|1.65|
73855503|NCT00487942|147257699|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.51|1.01||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.51|
73855504|NCT00487942|147257699|SUPERIORITY_OR_OTHER||Effect size|0.03|||||TWO_SIDED|95.0|-0.73|0.78||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.78|-0.73|
73855505|NCT00487942|147257699|SUPERIORITY_OR_OTHER||Effect size|-0.23|||||TWO_SIDED|95.0|-1.01|0.56||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.56|-1.01|
73963332|NCT00774397|147462343|SUPERIORITY_OR_OTHER|||||||0.0213||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||0.0213
73855506|NCT00487942|147257700|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.64|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.64|
73855507|NCT00487942|147257700|SUPERIORITY_OR_OTHER||Effect size|-0.02|||||TWO_SIDED|95.0|-0.79|0.74||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.74|-0.79|
73855508|NCT00487942|147257700|SUPERIORITY_OR_OTHER||Effect size|-0.3|||||TWO_SIDED|95.0|-1.11|0.5||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.50|-1.11|
73963333|NCT00774397|147462343|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
73963334|NCT00774397|147462343|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
73963335|NCT00774397|147462343|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
73963336|NCT00774397|147462343|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
73963337|NCT02765100|147462383|EQUIVALENCE|Unless specified otherwise, each of the statistical tests above will use a two-tailed alpha-level of 0.05.|Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|3.4|<|0.05|TWO_SIDED||||||t-test, 2 sided|||This is a pilot proof of concept study and does not require formal sample size calculations. High and low CRP groups will be compared on demographic, clinical and biological variables using two-sample t-tests or analysis of variance (ANOVA) tests for continuous variables (for nonparametric continuous variables, either Mann-Whitney tests or Kruskal-Wallis tests will be used) and chi-square tests or Fisher's exact tests for categorical variables.||||<0.05
73963338|NCT02652442|147462384|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the off-axis distance of 3.5 cm and 7.0 cm.||||0.97
73963339|NCT02652442|147462384|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the centrifugation duration of 1 minute and 3 minutes.||||0.51
73963340|NCT02652442|147462384|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the centrifugation schedule of daily OAR and biweekly OAR for a total of 5 sessions.||||0.44
73963341|NCT00106080|147462393|SUPERIORITY_OR_OTHER_LEGACY||Difference between groups after adjust|5.7||||0.03||||||No multiple comparisons, a priori threshold \< 0.05|GEE regression|Generalized estimating equations (GEE) regression, clustering for provider.||Power calculation: With 60 providers in each group, maintaining the probability of a type I error of 0.05, power of 0.90, provider level mean QOC score of 54.5 and provider level standard deviation in QOC score of 12.0, the minimal detectable difference in QOC score would be 7.5.||||0.03
74025413|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean fever score from period 1 to period 3 between the two arms."|Difference in Change|0.06||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 3 between the two arms"||||0.84
73905548|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|-18.5|||||TWO_SIDED|95.0|-29.4|-7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 4||-7.3|-29.4|
73905549|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-3.1|3.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 6B||3.0|-3.1|
73905550|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-5.9|7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 9V||7.3|-5.9|
73905551|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-10.3|3.1|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 14||3.1|-10.3|
73905552|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|-11.9|||||TWO_SIDED|95.0|-22.7|-1.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 18C||-1.0|-22.7|
73905553|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-7.1|0.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 19F||0.6|-7.1|
73905554|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-4.5|2.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 23F||2.3|-4.5|
73905555|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|25.0|||||TWO_SIDED|95.0|12.7|37.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 4||37.0|12.7|
73905556|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-0.011|7.715|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 6B||7.715|-0.011|
73905557|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|10.3|||||TWO_SIDED|95.0|1.9|19.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 9V||19.6|1.9|
73905558|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|29.7|||||TWO_SIDED|95.0|19.4|40.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 14||40.5|19.4|
73905559|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|30.0|||||TWO_SIDED|95.0|17.9|41.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 18C||41.5|17.9|
73905560|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|6.5|||||TWO_SIDED|95.0|1.2|13.9|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 19F||13.9|1.2|
73963342|NCT03740009|147462395|NON_INFERIORITY|For analyses the researchers used a paired T-test to compare baseline and post-treatment mean activation values across 3 regions of interest (ROIs): the caudate, putamen and nucleus accumbens.||||||0.53|||||||t-test, 2 sided|||\[Ho\]: TSEC has no meaningful effect on activity within key nodes of the frontostriate in response to reward.||||0.53
73905561|NCT01298544|147341981|SUPERIORITY_OR_OTHER||Difference in proportions|6.2|||||TWO_SIDED|95.0|1.8|13.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 23F||13.0|1.8|
73905562|NCT02718300|147341988|SUPERIORITY|||||||0.4046|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.4046
73905563|NCT02718300|147341990|SUPERIORITY|||||||0.7802|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.7802
73905564|NCT02718300|147341992|SUPERIORITY|||||||0.6856|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.6856
73905565|NCT02718300|147341994|SUPERIORITY|||||||0.3385|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.3385
73905566|NCT02718300|147341996|SUPERIORITY|||||||0.4005|||||||Van Elteren test|stratified by Easter Cooperative Oncology Group (ECOG) Performance Status at Screening (0 or 1 versus 2)||||||0.4005
73905567|NCT02718300|147341998|SUPERIORITY|||||||0.3138|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.3138
73905568|NCT02718300|147342004|SUPERIORITY|||||||0.3577|||||||ANOVA|||Week 2||||0.3577
73905569|NCT02718300|147342004|SUPERIORITY||Geometric Mean Ratio (GMR)|1.048|||||TWO_SIDED|95.0|0.791|1.388|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.388|0.791|
73905570|NCT02718300|147342004|SUPERIORITY||GMR|1.159|||||TWO_SIDED|95.0|0.936|1.435|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.435|0.936|
73905571|NCT02718300|147342004|SUPERIORITY|||||||0.1709|||||||ANOVA|||Week 4||||0.1709
73905572|NCT02718300|147342004|SUPERIORITY||GMR|1.0|||||TWO_SIDED|95.0|0.78|1.281|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.281|0.780|
73905573|NCT02718300|147342004|SUPERIORITY||GMR|1.176|||||TWO_SIDED|95.0|0.955|1.448|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.448|0.955|
73905574|NCT02718300|147342005|SUPERIORITY|||||||0.6693|||||||Kruskal-Wallis|||Week 2||||0.6693
73905575|NCT02718300|147342005|SUPERIORITY|||||||0.1521|||||||Kruskal-Wallis|||Week 4||||0.1521
73905576|NCT02718300|147342006|SUPERIORITY|||||||0.0809|||||||ANOVA|||Week 2||||0.0809
73905577|NCT02718300|147342006|SUPERIORITY||GMR|0.583|||||TWO_SIDED|95.0|0.342|0.994|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||0.994|0.342|
74025414|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean cough score from period 1 to period 3 between the two arms."|Difference in Change|0.07||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 3 between the two arms"||||0.84
74025415|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean heartburn score from period 1 to period 3 between the two arms."|Difference in Change|0.11||||0.54|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 3 between the two arms"||||0.54
74025416|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 3 between the two arms."|Difference in Change|0.14||||0.13|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 3 between the two arms"||||0.13
74025417|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean clumsy score from period 1 to period 3 between the two arms."|Difference in Change|0.18||||0.18|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 3 between the two arms"||||0.18
74025418|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.19||||0.29|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 3 between the two arms"||||0.29
74025419|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 3 between the two arms."|Difference in Change|0.2||||0.12|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 3 between the two arms"||||0.12
73855509|NCT00487942|147257701|SUPERIORITY_OR_OTHER||Effect size|-0.15|||||TWO_SIDED|95.0|-0.95|0.65||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.65|-0.95|
73855510|NCT00487942|147257701|SUPERIORITY_OR_OTHER||Effect size|-0.07|||||TWO_SIDED|95.0|-0.87|0.73||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.87|
73855511|NCT00487942|147257701|SUPERIORITY_OR_OTHER||Effect size|-0.43|||||TWO_SIDED|95.0|-1.24|0.38||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.38|-1.24|
73855512|NCT00487942|147257702|SUPERIORITY_OR_OTHER||Effect size|0.06|||||TWO_SIDED|95.0|-0.75|0.86||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.86|-0.75|
73855513|NCT00487942|147257702|SUPERIORITY_OR_OTHER||Effect size|-0.19|||||TWO_SIDED|95.0|-0.99|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.99|
73905578|NCT02718300|147342006|SUPERIORITY||GMR|0.986|||||TWO_SIDED|95.0|0.658|1.477|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.477|0.658|
73905579|NCT02718300|147342006|SUPERIORITY|||||||0.1525|||||||ANOVA|||Week 4||||0.1525
73905580|NCT02718300|147342006|SUPERIORITY||GMR|1.062|||||TWO_SIDED|95.0|0.604|1.867|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.867|0.604|
73855514|NCT00487942|147257702|SUPERIORITY_OR_OTHER||Effect size|-0.47|||||TWO_SIDED|95.0|-1.28|0.34||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.34|-1.28|
73855515|NCT03319953|147257717|SUPERIORITY|||||||0.2079||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>2.0.|Bayesian Normal Linear Model|||||||0.2079
73855516|NCT03319953|147257717|SUPERIORITY|||||||0.0633||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>2.0.|Bayesian Normal Linear Model|||||||0.0633
73855517|NCT03319953|147257718|SUPERIORITY|||||||0.1706||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>0.09.|Bayesian Normal Linear Model|||||||0.1706
73855518|NCT03319953|147257718|SUPERIORITY|||||||0.0373||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>0.09.|Bayesian Normal Linear Model|||||||0.0373
73855519|NCT01380535|147257735|OTHER|||||||0.373|||||||Fisher Exact|||||||0.373
73855520|NCT00306293|147257799|SUPERIORITY_OR_OTHER||Percent change from Placebo|-78.0|||<|0.001||95.0|||||Wilcoxon Rank Sum Test||Percent change in days with Subclinical HSV-2 Viral Shedding after VALTREX 1g treatment from the placebo|||||<0.001
73855521|NCT00306293|147257800|SUPERIORITY_OR_OTHER||Percent change from Baseline|-77.0||||0.014||95.0|||||Wilcoxon Rank Sum||Percent change in 'percentage of days with clinical HSV-2 viral shedding', after VALTREX 1g treatment from the placebo|||||0.014
73855522|NCT00218634|147257805|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||HLM|||We used HLM with weekly visit data for the acute outcome. There were, therefore, 11 time points used.||||<.05
73855523|NCT00218634|147257806|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||GLM - CBT-AD would be superior to ETAU at post. HLM - CBT-AD would be superior to CBT-AD at follow ups.|GLM and HLM|||||||<.05
73855524|NCT00218634|147257808|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||CD4 would be more improved in the treatment condition|HLM|||follow up analysis revealed that CD4, over time, significantly improved over control when covarying out baseline levels.||||<.05
73855525|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.136||0.499|TWO_SIDED|95.0|-0.36|0.18|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 3||0.18|-0.36|0.4990
73855526|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.135|<|0.0001|TWO_SIDED|95.0|-0.83|-0.29|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 3||-0.29|-0.83|<0.0001
73855527|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|-1.1|-0.56|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference is calculated as Test value minus Negative Control value.|Change from Baseline at Day 3||-0.56|-1.10|<0.0001
73855528|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.112||0.009|TWO_SIDED|95.0|-0.52|-0.08|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 14||-0.08|-0.52|0.0090
73855529|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.111|<|0.0001|TWO_SIDED|95.0|-0.89|-0.45|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 14||-0.45|-0.89|<0.0001
73855530|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.112|<|0.0001|TWO_SIDED|95.0|-1.66|-1.22|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 14||-1.22|-1.66|<0.0001
73855531|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.116||0.0007|TWO_SIDED|95.0|-0.63|-0.17|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 28||-0.17|-0.63|0.0007
73855532|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.116|<|0.0001|TWO_SIDED|95.0|-0.85|-0.39|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 28||-0.39|-0.85|<0.0001
73855533|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.85|-1.38|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 28||-1.38|-1.85|<0.0001
73855534|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.112||0.0015|TWO_SIDED|95.0|-0.59|-0.14|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 56||-0.14|-0.59|0.0015
73855535|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-1.05|-0.61|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 56||-0.61|-1.05|<0.0001
73905581|NCT02718300|147342006|SUPERIORITY||GMR|1.504|||||TWO_SIDED|95.0|0.937|2.414|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||2.414|0.937|
74025420|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 3 between the two arms."|Difference in Change|0.24||||0.1|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 3 between the two arms"||||0.10
74085018|NCT01765751|147723638|SUPERIORITY||Mean Difference (Net)|-2.8|||||TWO_SIDED|95.0|-7.6|2.0|||||Satisfaction with Social Role - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||2.0|-7.6|
73855536|NCT05243745|147257828|SUPERIORITY||Adjusted Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001|TWO_SIDED|95.0|-1.95|-1.49|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 56||-1.49|-1.95|<0.0001
73855537|NCT05243745|147257829|SUPERIORITY||Adjusted Mean Difference|5.93|STANDARD_ERROR_OF_MEAN|2.572||0.0231|TWO_SIDED|95.0|0.83|11.02|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 3||11.02|0.83|0.0231
73855538|NCT05243745|147257829|SUPERIORITY||Adjusted Mean Difference|18.42|STANDARD_ERROR_OF_MEAN|2.549|<|0.0001|TWO_SIDED|95.0|13.37|23.47|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 3||23.47|13.37|<0.0001
73855539|NCT05243745|147257829|SUPERIORITY||Adjusted Mean Difference|23.93|STANDARD_ERROR_OF_MEAN|2.571|<|0.0001|TWO_SIDED|95.0|18.83|29.02|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 3||29.02|18.83|<0.0001
73855540|NCT05243745|147257829|SUPERIORITY||Adjusted Mean Difference|8.97|STANDARD_ERROR_OF_MEAN|2.293||0.0002|TWO_SIDED|95.0|4.43|13.51|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 14||13.51|4.43|0.0002
73855541|NCT05243745|147257829|SUPERIORITY||Slope|17.71|STANDARD_ERROR_OF_MEAN|2.265|<|0.0001|TWO_SIDED|95.0|13.22|22.2|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 14||22.20|13.22|<0.0001
73855542|NCT05243745|147257829|SUPERIORITY||Adjusted Mean Difference|32.81|STANDARD_ERROR_OF_MEAN|2.288|<|0.0001|TWO_SIDED|95.0|28.27|37.34|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 14||37.34|28.27|<0.0001
73855543|NCT05243745|147257829|SUPERIORITY||Adjusted Mean Difference|10.2|STANDARD_ERROR_OF_MEAN|2.485|<|0.0001|TWO_SIDED|95.0|5.28|15.13|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 28||15.13|5.28|<0.0001
73855544|NCT05243745|147257829|SUPERIORITY||Adjusted Mean Difference|13.92|STANDARD_ERROR_OF_MEAN|2.46|<|0.0001|TWO_SIDED|95.0|9.05|18.8|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 28||18.80|9.05|<0.0001
73855545|NCT05243745|147257829|SUPERIORITY||Adjusted Mean Difference|36.51|STANDARD_ERROR_OF_MEAN|2.568|<|0.0001|TWO_SIDED|95.0|31.42|41.6|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 28||41.60|31.42|<0.0001
73855546|NCT05243745|147257829|SUPERIORITY||Adjusted Mean Difference|9.73|STANDARD_ERROR_OF_MEAN|2.761||0.0006|TWO_SIDED|95.0|4.26|15.2|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 56||15.20|4.26|0.0006
73855547|NCT05243745|147257829|SUPERIORITY||Adjusted Mean Difference|19.06|STANDARD_ERROR_OF_MEAN|2.772|<|0.0001|TWO_SIDED|95.0|13.57|24.55|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 56||24.55|13.57|<0.0001
73855548|NCT05243745|147257829|SUPERIORITY||Adjusted Mean Difference|39.33|STANDARD_ERROR_OF_MEAN|2.829|<|0.0001|TWO_SIDED|95.0|33.73|44.94|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 56||44.94|33.73|<0.0001
73905582|NCT02718300|147342007|SUPERIORITY|||||||0.2873|||||||ANOVA|||Week 2||||0.2873
73905583|NCT02718300|147342007|SUPERIORITY||GMR|1.016|||||TWO_SIDED|95.0|0.773|1.336|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.336|0.773|
73905584|NCT02718300|147342007|SUPERIORITY||GMR|1.161|||||TWO_SIDED|95.0|0.943|1.429|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.429|0.943|
73905585|NCT02718300|147342007|SUPERIORITY|||||||0.1601|||||||ANOVA|||Week 4||||0.1601
73905586|NCT02718300|147342007|SUPERIORITY||GMR|0.992|||||TWO_SIDED|95.0|0.773|1.274|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.274|0.773|
73963343|NCT03740009|147462396|NON_INFERIORITY|Analysis included MASQ-AD scores from all visits to characterize the change in scores from baseline to post-treatment.|GLM|-5.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|||||Mixed models of 3 week TSEC administration for MASQ-AD scores assessed at each study visit from baseline to post-treatment.|GLM||F value=13.26|\[Ho\] No change in depressive symptoms from baseline throughout 3 weeks of TSEC administration||||<0.001
73963344|NCT01061151|147462397|SUPERIORITY||Risk Difference (RD)|-1.3|||||TWO_SIDED|96.5|-2.1|-0.4|||||The combination of Arm B and Arm C minus Arm A, based on a repeated confidence interval (Lan-DeMets approach with an O'Brien-Fleming type I error spending function to preserve an experiment-wise type I error rate of 5%).|Arm B and Arm C were combined and compared to Arm A. This comparison was an a priori planned comparison.||-0.4|-2.1|
73963345|NCT01061151|147462398|SUPERIORITY|||||||0.008|||||||Fisher Exact|||Periods 1 and 2||||0.008
73963346|NCT01061151|147462398|SUPERIORITY|||||||0.77|||||||Fisher Exact|||Period 2||||0.77
73963347|NCT01061151|147462398|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Period 2||||>0.99
73963348|NCT01061151|147462399|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Periods 1 and 2||||0.30
73963349|NCT01061151|147462399|SUPERIORITY|||||||0.64|||||||Fisher Exact|||Period 2||||0.64
73963350|NCT01061151|147462399|SUPERIORITY|||||||0.06|||||||Fisher Exact|||Period 2||||0.06
73963351|NCT01061151|147462400|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Periods 1 and 2||||<0.001
73963352|NCT01061151|147462400|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Period 2||||0.04
73963353|NCT01061151|147462400|SUPERIORITY|||||||0.46|||||||Fisher Exact|||Period 2||||0.46
73855549|NCT01120236|147257839|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.24||||0.16|TWO_SIDED||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|An intention-to-treat approach was used in analysis of the primary endpoint. A 45% undetectable PSA \<= 0.2 ng/mL rate at 28 weeks was assumed for (control) arm II , based on data from SWOG 9346. Using a one-sided type I error rate of 0.10, we had 90% statistical power to detect an absolute difference of 20% in the undetectable PSA rate with the addition of cixutumumab using Fisher's exact test.||||0.16
73855550|NCT01120236|147257841|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82||||0.11|TWO_SIDED||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|Proportion of patients in each arm with PSA \> 4 ng/mL after seven cycles of protocol treatment were compared.||||0.11
73855551|NCT01971463|147257852|SUPERIORITY||||||<|0.05|||||||Wilcoxon signed rank|||Change in oCBF from baseline to post-bolus, ipsilesional hemisphere||||<0.05
73855552|NCT01971463|147257852|SUPERIORITY|Mixed effects regression, modeling the interaction term for time x normal saline bolus in the ipsilesional hemisphere|Slope|0.05|||<|0.001|TWO_SIDED|95.0|0.03|0.07|||Mixed Models Analysis|||||0.07|0.03|<0.001
73855553|NCT00420004|147257860|SUPERIORITY_OR_OTHER|||||||0.494|||||||Mixed Models Analysis|||||||0.494
73855554|NCT00664560|147257887|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-4.76|4.32|||ANCOVA|||||4.32|-4.76|
73855555|NCT00664560|147257888|NON_INFERIORITY_OR_EQUIVALENCE|10 mm Non-Inferiority (NI) margin between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-4.57|4.38|||ANCOVA|||||4.38|-4.57|
73855556|NCT00664560|147257889|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin 10 mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-5.08|4.14|||ANCOVA|||||4.14|-5.08|
73855557|NCT02456636|147257899|SUPERIORITY||Mean Difference (Net)|-1.87||||0.025|TWO_SIDED|97.5|-3.51|-0.23|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus FFS (in clinic individual counseling)||-0.23|-3.51|.025
73855558|NCT02456636|147257899|SUPERIORITY||Mean Difference (Net)|-1.36||||0.25|TWO_SIDED|97.5|-3.0|0.29|||Mixed Models Analysis|||DM (phone group counseling) versus FFS (in clinic individual counseling)||0.29|-3.00|0.25
73963354|NCT01061151|147462401|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|96.0|0.3|3.1|||||The confidence interval was based on a repeated confidence interval.|||3.1|0.3|
73963355|NCT01061151|147462402|SUPERIORITY|||||||0.98|||||||Log Rank|||||||0.98
73963356|NCT01061151|147462403|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.37|TWO_SIDED|95.0|0.14|2.08|||Log Rank||The hazard ratio compares Arm A relative to Arm B.|||2.08|0.14|0.37
73963357|NCT01061151|147462405|SUPERIORITY|||||||0.16|||||||Two-sided Z test|||Overall survival||||0.16
73963358|NCT01061151|147462405|SUPERIORITY|||||||0.0156|||||||Two-sided Z test|||Overall survival, period 2 group||||0.0156
73963359|NCT01061151|147462405|SUPERIORITY|||||||0.31|||||||Two-sided Z test|||Overall survival, period 2 group||||0.31
73963360|NCT01061151|147462405|SUPERIORITY|||||||0.0022|||||||Two-sided Z test|||Overall survival, period 2 group||||0.0022
73963361|NCT01061151|147462405|SUPERIORITY|||||||0.13|||||||Two-sided Z test|||HIV-free survival||||0.13
73963362|NCT01061151|147462405|SUPERIORITY|||||||0.44|||||||Two-sided Z test|||HIV-free survival, period 2 group||||0.44
73963363|NCT01061151|147462405|SUPERIORITY|||||||0.24|||||||Two-sided Z test|||HIV-free survival, period 2 group||||0.24
73963364|NCT01061151|147462405|SUPERIORITY|||||||0.26|||||||Two-sided Z test|||HIV-free survival, group 2||||0.26
73963365|NCT01852071|147462434|SUPERIORITY||Difference in percentages|14.29|||||TWO_SIDED|95.0|-5.4|42.81||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||42.81|-5.40|
73963366|NCT01852071|147462434|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||||
73963367|NCT01852071|147462434|SUPERIORITY||Difference in percentages|7.69|||||TWO_SIDED|95.0|-10.08|25.13||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||25.13|-10.08|
74025421|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 3 between the two arms."|Difference in Change|0.25||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 3 between the two arms"||||0.01
73963368|NCT01852071|147462435|SUPERIORITY||Difference in percentages|35.71|||||TWO_SIDED|95.0|11.21|64.86||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||64.86|11.21|
74025422|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 3 between the two arms."|Difference in Change|0.26||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 3 between the two arms"||||0.08
73855559|NCT02456636|147257899|SUPERIORITY||Mean Difference (Net)|-0.51||||0.025|TWO_SIDED|97.5|-2.15|1.13|||Mixed Models Analysis|||PCMH (in clinic group visits) versus DM (phone group visits)||1.13|-2.15|.025
73855560|NCT02456636|147257900|SUPERIORITY||Median Difference (Net)|-1.84||||0.025|TWO_SIDED|97.5|-3.5|-0.18|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus FFS (in clinic individual counseling).||-0.18|-3.50|.025
73855561|NCT02456636|147257900|SUPERIORITY||Median Difference (Net)|-1.34||||0.025|TWO_SIDED|97.5|-2.99|0.32|||Mixed Models Analysis|||DM (phone group counseling) versus FFS (in clinic individual counseling)||0.32|-2.99|.025
73855562|NCT02456636|147257900|SUPERIORITY||Mean Difference (Net)|-0.5||||0.025|TWO_SIDED|97.5|-2.15|1.15|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus DM (phone group counseling)||1.15|-2.15|.025
73855563|NCT01610557|147257919|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.039|TWO_SIDED|95.0|0.07|2.5|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.|||2.5|0.07|0.039
73855564|NCT01610557|147257920|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-48.0|||<|0.001|TWO_SIDED|95.0|-65.0|-31.0|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.|||-31|-65|<0.001
73855565|NCT02039219|147257921|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.4||0.1758|TWO_SIDED|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at baseline OCA arms had a mean (SD) of 14.9(2.4), Placebo arms had a mean (SD) of 16.4 (2.2).|Baseline||||0.1758
73855566|NCT02039219|147257921|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Net)|2.4|STANDARD_DEVIATION|6.8||0.3839|TWO_SIDED|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at day 42 OCA arms had a mean (SD) of 11.5 (6.8), Placebo arms had a mean (SD) of 13.9(4.6).|Day 42||||0.3839
73855567|NCT02039219|147257929|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|ONE_SIDED||||||Log Rank|||Day 42||||.3938
73855568|NCT02039219|147257929|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|TWO_SIDED||||||Log Rank|||Day 90||||.3938
73855569|NCT02039219|147257929|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|TWO_SIDED||||||Log Rank|||Day 180||||.3938
73855570|NCT02039219|147257929|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 42||||.3938
73855571|NCT02039219|147257929|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 90||||.3938
73855572|NCT02039219|147257929|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 180||||.3938
73855573|NCT02039219|147257933|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Final Values)|0.4|STANDARD_DEVIATION|2.5||0.8094|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.8094
73855574|NCT02974855|147257953|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.15||||0.0002|TWO_SIDED|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.29|0.08|0.0002
73855575|NCT02974855|147257953|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.05||||0.0001|TWO_SIDED|80.0|0.02|0.14|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.14|0.02|0.0001
73855576|NCT02974855|147257953|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.15||||0.0002|TWO_SIDED|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.29|0.08|0.0002
73905587|NCT02718300|147342007|SUPERIORITY||GMR|1.177|||||TWO_SIDED|95.0|0.955|1.452|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.452|0.955|
73905588|NCT02718300|147342011|SUPERIORITY|||||||0.083|||||||ANOVA|||Day 1||||0.0830
73905589|NCT02718300|147342011|SUPERIORITY||GMR|1.218|||||TWO_SIDED|95.0|0.846|1.753|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.753|0.846|
73905590|NCT02718300|147342011|SUPERIORITY||GMR|0.957|||||TWO_SIDED|95.0|0.654|1.399|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.399|0.654|
73905591|NCT02718300|147342011|SUPERIORITY||GMR|0.943|||||TWO_SIDED|95.0|0.656|1.354|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.354|0.656|
73905592|NCT02718300|147342011|SUPERIORITY||GMR|0.867|||||TWO_SIDED|95.0|0.579|1.298|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.298|0.579|
73855577|NCT02974855|147257953|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.03||||0.0005|TWO_SIDED|80.0|0.01|0.1|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.10|0.01|0.0005
73855578|NCT02974855|147257953|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.09|||<|0.0001|TWO_SIDED|80.0|0.05|0.16|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.16|0.05|<0.0001
73905593|NCT02718300|147342011|SUPERIORITY|||||||0.2402|||||||ANOVA|||Week 4||||0.2402
73905594|NCT02718300|147342011|SUPERIORITY||GMR|0.702|||||TWO_SIDED|95.0|0.461|1.069|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.069|0.461|
73905595|NCT02718300|147342011|SUPERIORITY||GMR|0.7|||||TWO_SIDED|95.0|0.456|1.073|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.073|0.456|
73855579|NCT02974855|147257953|SUPERIORITY||ratio|0.18|||<|0.0001|TWO_SIDED|80.0|0.11|0.31|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.31|0.11|<0.0001
73855580|NCT02974855|147257953|SUPERIORITY||ratio|0.1||||0.0002|TWO_SIDED|80.0|0.04|0.22|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.22|0.04|0.0002
73855581|NCT02974855|147257953|SUPERIORITY||ratio|0.2||||0.0154|TWO_SIDED|80.0|0.09|0.47|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.47|0.09|0.0154
73855582|NCT02974855|147257953|SUPERIORITY||ratio|0.04||||0.0005|TWO_SIDED|80.0|0.01|0.14|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.14|0.01|0.0005
73855583|NCT02974855|147257953|SUPERIORITY||ratio|0.12|||<|0.0001|TWO_SIDED|80.0|0.08|0.2|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.20|0.08|<0.0001
73855584|NCT00129701|147257970|SUPERIORITY|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||||||0.064
73905596|NCT02718300|147342011|SUPERIORITY||GMR|0.638|||||TWO_SIDED|95.0|0.428|0.951|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||0.951|0.428|
73905597|NCT02718300|147342011|SUPERIORITY||GMR|0.627|||||TWO_SIDED|95.0|0.397|0.99|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||0.990|0.397|
73905598|NCT02718300|147342012|SUPERIORITY|||||||0.0756|||||||Kruskal-Wallis|||Day 1||||0.0756
73905599|NCT02718300|147342012|SUPERIORITY|||||||0.0866|||||||Kruskal-Wallis|||Week 4||||0.0866
73905600|NCT02718300|147342013|SUPERIORITY|||||||0.4287|||||||ANOVA|||Day 1||||0.4287
73905601|NCT02718300|147342013|SUPERIORITY||GMR|1.272|||||TWO_SIDED|95.0|0.329|4.914|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||4.914|0.329|
73905602|NCT02718300|147342013|SUPERIORITY||GMR|1.036|||||TWO_SIDED|95.0|0.252|4.251|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||4.251|0.252|
73905603|NCT02718300|147342013|SUPERIORITY||GMR|0.702|||||TWO_SIDED|95.0|0.18|2.731|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||2.731|0.180|
73905604|NCT02718300|147342013|SUPERIORITY||GMR|0.525|||||TWO_SIDED|95.0|0.118|2.348|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||2.348|0.118|
73905605|NCT02718300|147342013|SUPERIORITY|||||||0.9788|||||||ANOVA|||Week 4||||0.9788
73905606|NCT02718300|147342013|SUPERIORITY||GMR|0.879|||||TWO_SIDED|95.0|0.198|3.896|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||3.896|0.198|
73905607|NCT02718300|147342013|SUPERIORITY||GMR|1.225|||||TWO_SIDED|95.0|0.27|5.56|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||5.560|0.270|
73905608|NCT02718300|147342013|SUPERIORITY||GMR|0.918|||||TWO_SIDED|95.0|0.221|3.821|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||3.821|0.221|
73905609|NCT02718300|147342013|SUPERIORITY||GMR|0.853|||||TWO_SIDED|95.0|0.169|4.299|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||4.299|0.169|
73905610|NCT02718300|147342014|SUPERIORITY|||||||0.1208|||||||ANOVA|||Day 1||||0.1208
73905611|NCT02718300|147342014|SUPERIORITY||GMR|1.251|||||TWO_SIDED|95.0|0.832|1.879|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.879|0.832|
73905612|NCT02718300|147342014|SUPERIORITY||GMR|0.992|||||TWO_SIDED|95.0|0.649|1.518|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.518|0.649|
74025423|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean dizziness score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 3 between the two arms"||||0.08
74025424|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.09|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 3 between the two arms"||||0.09
73855585|NCT03576066|147257973|OTHER|||||||0.6855|||||||Repeated measures analysis|||Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.6855
73855586|NCT03576066|147257973|OTHER|||||||0.175|||||||Repeated measures analysis|||LS mean difference in HBeAg-negative participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.1750
73855587|NCT03576066|147257974|OTHER|||||||0.2916|||||||Repeated measures analysis|||Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.2916
73855588|NCT02642393|147258009|OTHER||Slope|1.256|STANDARD_ERROR_OF_MEAN|0.943||0.183|TWO_SIDED|95.0|-0.594|3.106|||Mixed Models Analysis|||||3.106|-0.594|0.183
73855589|NCT02642393|147258010|OTHER||Rate Ratio|1.08||||0.124|TWO_SIDED|95.0|0.979|1.192|||Poisson Regression|||||1.192|0.979|0.124
73855590|NCT02642393|147258011|OTHER||Rate Ratio|1.154||||0.004|TWO_SIDED|95.0|1.046|1.273|||Poisson Regression|||||1.273|1.046|0.004
73855591|NCT02642393|147258012|OTHER|||||||0.002|||||||Log Rank|||||||0.002
73855592|NCT02642393|147258013|OTHER|||||||0.497|||||||Log Rank|||||||0.497
73855593|NCT02642393|147258014|OTHER||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.385||0.856|TWO_SIDED|95.0|-0.825|0.685|||Mixed Models Analysis|||||0.685|-0.825|0.856
73855594|NCT02642393|147258015|OTHER||Slope|0.076|STANDARD_ERROR_OF_MEAN|0.226||0.736|TWO_SIDED|95.0|-0.368|0.521|||Mixed Models Analysis|||Anxiety||0.521|-0.368|0.736
73855595|NCT02642393|147258015|OTHER||Slope|0.295|STANDARD_ERROR_OF_MEAN|0.213||0.167|TWO_SIDED|95.0|-0.124|0.714|||Mixed Models Analysis|||Cognitive Function||0.714|-0.124|0.167
73855596|NCT02642393|147258015|OTHER||Slope|0.256|STANDARD_ERROR_OF_MEAN|0.111||0.022|TWO_SIDED|95.0|0.038|0.474|||Mixed Models Analysis|||Communication||0.474|0.038|0.022
73855597|NCT02642393|147258015|OTHER||Slope|0.095|STANDARD_ERROR_OF_MEAN|0.173||0.584|TWO_SIDED|95.0|-0.245|0.435|||Mixed Models Analysis|||Emotional and Behavioral Dyscontrol||0.435|-0.245|0.584
73855598|NCT02642393|147258015|OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.28||0.973|TWO_SIDED|95.0|-0.56|0.541|||Mixed Models Analysis|||Fatigue||0.541|-0.560|0.973
73855599|NCT02642393|147258015|OTHER||Slope|0.169|STANDARD_ERROR_OF_MEAN|0.136||0.214|TWO_SIDED|95.0|-0.098|0.437|||Mixed Models Analysis|||Lower Extremity Function||0.437|-0.098|0.214
73855600|NCT02642393|147258015|OTHER||Slope|-0.334|STANDARD_ERROR_OF_MEAN|0.304||0.271|TWO_SIDED|95.0|-0.931|0.262|||Mixed Models Analysis|||Positive Affect and Well-Being||0.262|-0.931|0.271
73855601|NCT02642393|147258015|OTHER||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.566|TWO_SIDED|95.0|-0.355|0.194|||Mixed Models Analysis|||Stigma||0.194|-0.355|0.566
73855602|NCT02642393|147258015|OTHER||Slope|0.212|STANDARD_ERROR_OF_MEAN|0.14||0.13|TWO_SIDED|95.0|-0.063|0.487|||Mixed Models Analysis|||Upper Extremity Function||0.487|-0.063|0.130
73855603|NCT02642393|147258015|OTHER||Slope|0.072|STANDARD_ERROR_OF_MEAN|0.202||0.723|TWO_SIDED|95.0|-0.325|0.468|||Mixed Models Analysis|||Sleep Disturbance||0.468|-0.325|0.723
73855604|NCT02642393|147258015|OTHER||Slope|-0.006|STANDARD_ERROR_OF_MEAN|0.298||0.984|TWO_SIDED|95.0|-0.592|0.579|||Mixed Models Analysis|||Satisfaction with Social Roles and Activities||0.579|-0.592|0.984
73855605|NCT02642393|147258015|OTHER||Slope|-0.253|STANDARD_ERROR_OF_MEAN|0.317||0.426|TWO_SIDED|95.0|-0.877|0.371|||Mixed Models Analysis|||Participation in Social Roles and Activities||0.371|-0.877|0.426
73855606|NCT02642393|147258016|OTHER||Slope|-0.106|STANDARD_ERROR_OF_MEAN|0.141||0.454|TWO_SIDED|95.0|-0.382|0.171|||Mixed Models Analysis|||||0.171|-0.382|0.454
73855607|NCT02642393|147258017|OTHER||Slope|0.047|STANDARD_ERROR_OF_MEAN|0.413||0.91|TWO_SIDED|95.0|-0.764|0.858|||Mixed Models Analysis|||||0.858|-0.764|0.910
73855608|NCT02642393|147258018|OTHER||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.758|TWO_SIDED|95.0|-0.295|0.215|||Mixed Models Analysis|||||0.215|-0.295|0.758
73855609|NCT02642393|147258019|OTHER||Slope|-0.208|STANDARD_ERROR_OF_MEAN|0.803||0.796|TWO_SIDED|95.0|-1.783|1.367|||Mixed Models Analysis|||BL to V01||1.367|-1.783|0.796
73855610|NCT02642393|147258019|OTHER||Slope|-2.4|STANDARD_ERROR_OF_MEAN|3.443||0.486|TWO_SIDED|95.0|-9.156|4.355|||Mixed Models Analysis|||V10 to SV||4.355|-9.156|0.486
73855611|NCT00365105|147258032|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.844|TWO_SIDED|95.0|0.7|1.54|||Log Rank|||Assuming an exponential distribution, the weighted yearly SRE hazard rate for patients treated with bisphosphonates only is 0.7991 which translates to a median time to SRE of 10.4 months. The study was designed to show a 33% relative reduction in the yearly SRE hazard rate, i.e. 15.6 months median time to SRE. Using a two-sided log-rank test assuming a type I error of 0.05, one planned interim analysis with 90% statistical power, 257 SREs are required with a total of 316 patients.||1.54|0.70|0.844
73855612|NCT00365105|147258033|SUPERIORITY|The power of detecting an improvement from 55% in the control arm to 41% in the experimental arm with a two-sided Fisher's exact test at alpha 0.05 is 66%.||||||0.26|||||||Fisher Exact|||||||0.26
73905613|NCT02718300|147342014|SUPERIORITY||GMR|0.967|||||TWO_SIDED|95.0|0.645|1.45|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.450|0.645|
73905614|NCT02718300|147342014|SUPERIORITY||GMR|0.86|||||TWO_SIDED|95.0|0.548|1.35|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.350|0.548|
73905615|NCT02718300|147342014|SUPERIORITY|||||||0.3218|||||||ANOVA|||Week 4||||0.3218
74025425|NCT03182738|147604029|SUPERIORITY|"Linear mixed models to test difference in mean depression score from period 1 to period 3 between the two arms."|Difference in Change|0.38||||0.05|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 3 between the two arms"||||0.05
74025426|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-2.09||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms||||0.83
74025427|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.94||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms||||0.83
74025428|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.79||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 3 months between two arms||||0.83
74025429|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.78||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms||||0.83
74025430|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.04||||0.98|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm"|The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms||||0.98
73855613|NCT00365105|147258034|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.37|TWO_SIDED|95.0|0.86|1.52|||Log Rank|||Assuming the disease site distribution is 40%, 40%, and 20% from prostate, breast, and lung cancer populations, respectively, the weighted yearly death rate for patients treated with bisphosphonates only is 0.4390, translating to a median overall survival time of 18.9 months assuming an exponential distribution. Statistical power to detect a relative difference of 33% in the yearly death rate is 70% using a two-sided log-rank test at a 0.05 significance level and 87% to detect 50% difference.||1.52|0.86|0.37
73855614|NCT00365105|147258035|SUPERIORITY|||||||0.96||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||FACT-G Total||||0.96
73855615|NCT00365105|147258035|SUPERIORITY|||||||0.97||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Physical Well-Being||||0.97
73855616|NCT00365105|147258035|SUPERIORITY|||||||0.57||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Social/Family Well-Being||||0.57
73855617|NCT00365105|147258035|SUPERIORITY|||||||0.7||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Emotional Well-Being||||0.70
73855618|NCT00365105|147258035|SUPERIORITY|||||||0.46||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Functional Well-Being||||0.46
73855619|NCT00365105|147258036|SUPERIORITY|||||||0.99||||||2-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
73855620|NCT00365105|147258037|SUPERIORITY|||||||0.43||||||Significance level of 0.05|t-test, 2 sided|||Index Score||||0.43
73855621|NCT00365105|147258037|SUPERIORITY|||||||0.15||||||Significance level of 0.05|t-test, 2 sided|||VAS Score||||0.15
73855622|NCT00608023|147258038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
73855623|NCT00608023|147258039|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
73855624|NCT00608023|147258040|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
73855625|NCT00608023|147258041|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
73855626|NCT00608023|147258042|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
73855627|NCT03130439|147258057|OTHER||Objective Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.247||||||||0.247|0.000|
73855628|NCT03130439|147258060|OTHER||Disease Control Rate|0.222|||||TWO_SIDED|95.0|0.086|0.423||||||||0.423|0.086|
73855629|NCT03130439|147258061|OTHER||Clinical Benefit Rate|0.148|||||TWO_SIDED|95.0|0.042|0.337||||||||0.337|0.042|
73905616|NCT02718300|147342014|SUPERIORITY||GMR|0.761|||||TWO_SIDED|95.0|0.482|1.2|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.200|0.482|
73905617|NCT02718300|147342014|SUPERIORITY||GMR|0.803|||||TWO_SIDED|95.0|0.506|1.277|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.277|0.506|
73905618|NCT02718300|147342014|SUPERIORITY||GMR|0.667|||||TWO_SIDED|95.0|0.432|1.028|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.028|0.432|
73905619|NCT02718300|147342014|SUPERIORITY||GMR|0.64|||||TWO_SIDED|95.0|0.39|1.051|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.051|0.390|
73905620|NCT02452697|147342018|SUPERIORITY|||||||0.4|||||||Log Rank|||||||0.40
73905621|NCT05419908|147342032|SUPERIORITY||LSMean Difference|-12.34|||<|0.001|TWO_SIDED|95.0|-16.89|-7.79||Least square (LS) mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|Analysis of Covariance (ANCOVA)||||-7.79|-16.89|<0.001
73905622|NCT05419908|147342033|SUPERIORITY||LSMean Difference|-1.134|||<|0.001|TWO_SIDED|95.0|-1.466|-0.802||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-0.802|-1.466|<0.001
73905623|NCT05419908|147342033|SUPERIORITY||LSMean Difference|-0.948|||<|0.001||95.0|-1.362|-0.535||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-0.535|-1.362|<0.001
73905624|NCT05419908|147342033|SUPERIORITY||LSMean Difference|-1.122|||<|0.001|TWO_SIDED|95.0|-1.504|-0.741||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-0.741|-1.504|<0.001
74085019|NCT03429049|147723645|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.256||0.1904|TWO_SIDED|95.0|-0.84|0.17|||Mixed Models Analysis|||The NRS least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.17|-0.84|0.1904
73905625|NCT05419908|147342034|SUPERIORITY||LSMean Difference|-13.28|||<|0.001||95.0|-17.02|-9.54||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-9.54|-17.02|<0.001
73905626|NCT05419908|147342034|SUPERIORITY||LSMean Difference|-11.78|||<|0.001|TWO_SIDED|95.0|-16.3|-7.27||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-7.27|-16.30|<0.001
73905627|NCT05419908|147342034|SUPERIORITY||LSMean Difference|-12.42|||<|0.001||95.0|-17.0|-7.83||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-7.83|-17.00|<0.001
73905628|NCT05419908|147342035|SUPERIORITY||LSMean Difference|-39.8|||<|0.001|TWO_SIDED|95.0|-50.5|-29.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-29.1|-50.5|<0.001
73905629|NCT05419908|147342035|SUPERIORITY||LSMean Difference|-35.5|||<|0.001|TWO_SIDED|95.0|-47.9|-23.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-23.0|-47.9|<0.001
73905630|NCT05419908|147342035|SUPERIORITY||LSMean Difference|-35.0|||<|0.001||95.0|-47.9|-22.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-22.1|-47.9|<0.001
73905631|NCT05419908|147342036|SUPERIORITY||Percentage Difference|65.1|||<|0.001|TWO_SIDED|95.0|49.15|81.0||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||81.00|49.15|<0.001
73905632|NCT05419908|147342036|SUPERIORITY||Percentage Difference|48.5|||<|0.001||95.0|30.37|66.59||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||66.59|30.37|<0.001
73905633|NCT05419908|147342036|SUPERIORITY||Percentage Difference|52.5|||<|0.001|TWO_SIDED|95.0|35.76|69.24||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||69.24|35.76|<0.001
73905634|NCT05419908|147342037|SUPERIORITY||Percentage Difference|69.0|||<|0.001|TWO_SIDED|95.0|53.7|84.21||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||84.21|53.70|<0.001
73905635|NCT05419908|147342037|SUPERIORITY||Percentage Difference|50.7|||<|0.001||95.0|31.93|69.42||Likelihood-ratio test based 95% confidence interval of the percentage difference|Likelihood-Ratio Chi-Square Test|||Week 8||69.42|31.93|<0.001
73905636|NCT05419908|147342037|SUPERIORITY||Percentage Difference|57.5|||<|0.001|TWO_SIDED|95.0|39.99|75.01||Likelihood-ratio test based 95% confidence interval of the percentage difference|Likelihood-Ratio Chi-Square Test|||Week 12||75.01|39.99|<0.001
73905637|NCT05419908|147342038|SUPERIORITY||Percentage Difference|54.2|||<|0.001|TWO_SIDED|95.0|37.47|70.84||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||70.84|37.47|<0.001
73963369|NCT01852071|147462435|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||||
73963370|NCT01852071|147462435|SUPERIORITY||Difference in percentages|19.23|||||TWO_SIDED|95.0|0.71|39.35||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||39.35|0.71|
73855630|NCT00729677|147258067|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||.05
73855631|NCT01973387|147258091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.178|||<|0.0001|TWO_SIDED|95.0|0.109|0.291|||Log Rank|||||0.291|0.109|<0.0001
73855632|NCT02512874|147258108|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
73855633|NCT03888235|147258114|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||The null hypothesis assumes that after one month, there is no difference in Oswestry low back pain and disability score improvement between the three treatment groups.||||0.003
73855634|NCT03888235|147258114|SUPERIORITY|||||||0.001||||||SI Exercise versus usual care. Bonferroni alpha correction p\< 0.0167|Wilcoxon (Mann-Whitney)|||||||0.001
73855635|NCT03888235|147258114|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in Oswestry low back pain and disability score between those using a pelvic support belt and those using usual treatment||||0.314
73855636|NCT03888235|147258115|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||Oswestry low back pain and disability (ODI) score change over two months for all participants. This compares the score at initial visit and the score 2 months later after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. =(ODI time 0 - ODI 2 months). The greater the difference, the better the recovery of back function.||||< 0.001
73855637|NCT03888235|147258116|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||The null hypothesis assumes that after one month, there is no difference in brief pain inventory score improvement between the three treatment groups.||||0.17
73855638|NCT03888235|147258116|SUPERIORITY|||||||0.089||||||Bonferroni alpha correction of p\<0.0167.|Wilcoxon (Mann-Whitney)|||The brief pain inventory score at the one month visit, is used to compare the pain levels of those having done one month of corrective exercises to those who continued with conventional treatments for their low back pain.||||0.089
73855639|NCT03888235|147258116|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||The brief pain inventory score is used to compare those using a pelvic support belt for one month and those with delayed treatment||||0.092
73855640|NCT03888235|147258117|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||All participants are assessed as a single group as they receive the same two treatments for one month. Brief pain inventory (BPI) score change over two months for all participants. This compares BPI score at baseline visit and BPI score 2 months later, after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. The score is between 0 and 10. The higher the change in score the greater the pain relief.||||< 0.001
73855641|NCT03888235|147258118|SUPERIORITY|||||||0.016||||||The Bonferroni alpha correction is used p\<0.0167|Kruskal-Wallis|||The null hypothesis assumes there is no improvement after one month in posterior superior iliac spine levels (PSISL) measured using the sacroiliac forward flexion test (SIFFT) between the three treatment groups.||||0.016
73855642|NCT03888235|147258118|SUPERIORITY|||||||0.009||||||The Bonferroni alpha correction is used p\<0.0167|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the distance between the posterior sacroiliac spine levels (PSISL) between those who use their usual low back pain treatments and those who are given the corrective exercises (SIFFTE) and use them as needed for one month.||||0.009
73855643|NCT03888235|147258118|SUPERIORITY|||||||0.034||||||Bonferroni correction p\< 0.0167|Wilcoxon (Mann-Whitney)|||The null hypothesis is that that using a pelvic support belt will not help correct sacroiliac joint asymmetry as measured using the distance between the posterior superior iliac spine levels (PSISL), baseline and one month later better than conventional treatment for low back pain.||||0.034
73855644|NCT03888235|147258119|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Since all participants have received the same 2 treatment for one month, we will treat them as a single group. We will measure the distance between their posterior superior iliac spine levels (PSISL) when they enter the study and two months later after they have used the corrective exercise and the sacroiliac belt for one month. Corona prevented some participants from returning for examination, which this test requires. Only 11 participants were present in each group: 33 participants tested.||||< 0.0001
73855645|NCT03888235|147258119|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||< 0.001
73855646|NCT03888235|147258120|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the physiotherapy as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
73905638|NCT05419908|147342038|SUPERIORITY||Percentage Difference|47.8|||<|0.001||95.0|29.62|65.99||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||65.99|29.62|<0.001
73905639|NCT05419908|147342038|SUPERIORITY||Percentage Difference|47.5|||<|0.001||95.0|28.86|66.14||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||66.14|28.86|<0.001
73963371|NCT01852071|147462436|SUPERIORITY||Difference in percentages|14.29|||||TWO_SIDED|95.0|-5.4|42.81||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||42.81|-5.40|
73963372|NCT01852071|147462436|SUPERIORITY||Difference in percentages|9.09|||||TWO_SIDED|95.0|-9.55|41.28||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||41.28|-9.55|
73963373|NCT01852071|147462436|SUPERIORITY||Difference in percentages|12.0|||||TWO_SIDED|95.0|-5.62|31.22||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||31.22|-5.62|
73963374|NCT01852071|147462437|SUPERIORITY||Difference in percentages|50.0|||||TWO_SIDED|95.0|22.71|76.96||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||76.96|22.71|
73963375|NCT01852071|147462437|SUPERIORITY||Difference in percentages|36.36|||||TWO_SIDED|95.0|9.8|69.21||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||69.21|9.80|
73963376|NCT01852071|147462437|SUPERIORITY||Difference in percentages|44.0|||||TWO_SIDED|95.0|22.78|65.23||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||65.23|22.78|
73963377|NCT01290341|147462450|SUPERIORITY_OR_OTHER||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification by site was used to compare subjects with complete cure between NAFT-600 and Placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the Placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1\<=p0 versus Ha (alternate): p1\>p0, where p0 and p1 are the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."||||<0.025
73963378|NCT01102231|147462456|OTHER||Proportion difference|0.905|||||TWO_SIDED|95.0|0.846|0.964||||||||0.964|0.846|
73963379|NCT02214550|147462466|SUPERIORITY||Slope|-1.96|STANDARD_ERROR_OF_MEAN|0.69||0.02|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (OCP vs. No OCP). PBS participants are included in the OCP group|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.02
73963380|NCT02214550|147462466|SUPERIORITY||Slope|-1.4597|STANDARD_ERROR_OF_MEAN|0.8245||0.08|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.08
73905640|NCT05419908|147342039|SUPERIORITY||Percentage Difference|49.7|||<|0.001||95.0|33.54|65.79||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||65.79|33.54|<0.001
73963381|NCT02214550|147462466|SUPERIORITY||Slope|1.9186|STANDARD_ERROR_OF_MEAN|0.8121||0.023|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates a time x group interaction (D+COS-continuous microgestin vs. PBS-continuous microgestin).|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.023
73971057|NCT02969707|147482294|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable.||||||0.041|||||||Regression, Linear|(R² = .083, F(1,49) = 4.425, β = .288, p = .041)||In people with FMS, the linear relationship between Thermal Pain Threshold and E/I ratio as it relates to creatine was assessed.||||0.041
74025431|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.55||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.||||0.83
73855647|NCT03888235|147258121|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the acupuncture as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
73855648|NCT03888235|147258122|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||The null hypothesis is that all participants were as satisfied with the yoga exercises as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
73855649|NCT03888235|147258123|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the core exercises as they were with using the corrective exercise and the pelvic stabilization belt||||<0.00001
73855650|NCT03888235|147258124|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with treatments by a chiropractor as they were with using the corrective exercise and the pelvic stabilization belt||||<0.00001
73855651|NCT03888235|147258125|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||The null hypothesis is that all participants were as satisfied with massage therapy as they were with using the corrective exercise and the pelvic stabilization belt.||||<0.00001
73855652|NCT02357472|147258126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample Size to Achieve 0.80 Power to Test Equivalency at the α = 0.05 Significance Level for True Proportions|Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|1.31||0.0003|TWO_SIDED|95.0|0.6216|2.002|||t-test, 2 sided|||It was caculated that 60 paticipants randomized in a 1:1between 2 arms would would have at least 85% power to detect a difference of 1.32 oocytes between the high dose group and standard dose group after 12 weeks.Sample size was determined using 2 sided 2 sample t-test (α = 0.05).Assumptions included a common standard deviation of 1.72.||2.002|0.6216|0.0003
73855653|NCT00803400|147258140|OTHER||Mean Difference (Final Values)|1.0|||<|0.001|ONE_SIDED||||||t-test, 1 sided|||A p-value less than 0.05 (≤ 0.05) is statistically significant. It indicates strong evidence against the null hypothesis, as there is less than a 5% probability the null is correct (and the results are random)||||<0.001
73855654|NCT03525600|147258143|SUPERIORITY||LS Mean Difference|-0.2296||||0.0615|TWO_SIDED|95.0|-0.4703|0.0111|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||0.0111|-0.4703|0.0615
73855655|NCT03525600|147258143|SUPERIORITY||LS Mean Difference|-0.2077||||0.0854|TWO_SIDED|95.0|-0.4444|0.029|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||0.0290|-0.4444|0.0854
73855656|NCT03525600|147258144|SUPERIORITY||LS Mean Difference|-0.7451||||0.0004|TWO_SIDED|95.0|-1.1539|-0.3362|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.3362|-1.1539|0.0004
73855657|NCT03525600|147258144|SUPERIORITY||LS Mean Difference|-0.6331||||0.003|TWO_SIDED|95.0|-1.0508|-0.2153|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.2153|-1.0508|0.0030
73855658|NCT03525600|147258145|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.0547||||0.4282|TWO_SIDED|95.0|-0.1899|0.0806|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0806|-0.1899|0.4282
73855659|NCT03525600|147258145|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.0793||||0.2457|TWO_SIDED|95.0|-0.2131|0.0546|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0546|-0.2131|0.2457
73905641|NCT05419908|147342039|SUPERIORITY||Percentage Difference|43.8|||<|0.001|TWO_SIDED|95.0|27.83|59.85||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||59.85|27.83|<0.001
73905642|NCT05419908|147342039|SUPERIORITY||Percentage Difference|42.5|||<|0.001||95.0|26.34|58.66||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||58.66|26.34|<0.001
73905643|NCT05419908|147342040|SUPERIORITY||Percentage Difference|62.8|||<|0.001|TWO_SIDED|95.0|46.56|79.05||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||79.05|46.56|<0.001
73855660|NCT03525600|147258145|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1722||||0.0292|TWO_SIDED|95.0|-0.327|-0.0174|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0174|-0.3270|0.0292
73855661|NCT03525600|147258145|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1659||||0.0352|TWO_SIDED|95.0|-0.3202|-0.0115|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0115|-0.3202|0.0352
73855662|NCT03525600|147258145|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.145||||0.0514|TWO_SIDED|95.0|-0.2909|0.0009|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0009|-0.2909|0.0514
73855663|NCT03525600|147258145|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.168||||0.0265|TWO_SIDED|95.0|-0.3164|-0.0196|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0196|-0.3164|0.0265
73855664|NCT03525600|147258145|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.3532|||<|0.0001|TWO_SIDED|95.0|-0.5245|-0.1819|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1819|-0.5245|<0.0001
73855665|NCT03525600|147258145|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2848||||0.0002|TWO_SIDED|95.0|-0.4336|-0.1361|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1361|-0.4336|0.0002
73855666|NCT03525600|147258145|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.7251||||0.0006|TWO_SIDED|95.0|-1.1373|-0.3129|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.3129|-1.1373|0.0006
73905644|NCT05419908|147342040|SUPERIORITY||Percentage Difference|46.2|||<|0.001|TWO_SIDED|95.0|28.85|63.47||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||63.47|28.85|<0.001
73905645|NCT05419908|147342040|SUPERIORITY||Percentage Difference|57.5|||<|0.001|TWO_SIDED|95.0|41.57|73.43||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||73.43|41.57|<0.001
73963382|NCT02214550|147462467|SUPERIORITY||Slope|0.3716|STANDARD_ERROR_OF_MEAN|0.3056||0.2315|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time\*group interaction (OCP vs. No OCP). PBS participants are included in the OCP group|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.2315
73963383|NCT02214550|147462467|SUPERIORITY||Slope|0.2703|STANDARD_ERROR_OF_MEAN|0.3244||0.4097|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.4097
73963384|NCT02214550|147462467|SUPERIORITY||Slope|-0.1574|STANDARD_ERROR_OF_MEAN|0.3283||0.6341|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (continuous microgestin: D+COS-vs. PBS) interaction.|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.6341
73963385|NCT02214550|147462468|SUPERIORITY||Slope|0.086|STANDARD_ERROR_OF_MEAN|0.1||0.393|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (OCP vs. No OCP). PBS participants are included in the OCP group.|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The OCP vs No OCP contrast was estimated here:||||.393
73963386|NCT02214550|147462468|SUPERIORITY||Slope|0.007|STANDARD_ERROR_OF_MEAN|0.09||0.941|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameters reported indicates time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The cyclic vs. continuous microgestin contrast was run here||||0.941
73963387|NCT02214550|147462468|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.1||0.005|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (D+COS-continuous microgestin vs. PBS-continuous microgestin).|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The PBS-continuous microgestin vs. D+COS-continuous microgestin contrast was evaluated here||||0.005
73963388|NCT02409667|147462483|NON_INFERIORITY|The statistical null-hypothesis to be rejected in the primary analysis was that the odds ratio of maintaining a PASI 90 response for patients with secukinumab 4-weekly dosing versus patients on secukinumab 6-weekly dosing exceeds the non-inferiority margin of 1+δ.|Odds Ratio (OR)|1.91||||0.1499|TWO_SIDED|95.0|1.44|2.55|||Regression, Logistic|||||2.55|1.44|0.1499
73963389|NCT02409667|147462484|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1013|TWO_SIDED|95.0|0.35|1.1|||Regression, Logistic|||||1.10|0.35|0.1013
73963390|NCT02409667|147462487|SUPERIORITY||Least square mean (LSM) estimate|-0.09||||0.0489|TWO_SIDED|95.0|-0.18|0.0|||ANCOVA|||Week 28||-0.00|-0.18|0.0489
74085020|NCT03429049|147723646|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.206||0.0257|TWO_SIDED|95.0|-5.07|-0.33|||Mixed Models Analysis|||The WOMAC A least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||-0.33|-5.07|0.0257
73855667|NCT03525600|147258145|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.698||||0.001|TWO_SIDED|95.0|-1.1142|-0.2817|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.2817|-1.1142|0.0010
73855668|NCT01191736|147258149|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|Null hypothesis: the medians for all seven arms are equal.||Kruskal-Wallis test for multiple comparisons||||.05
74085021|NCT03429049|147723647|SUPERIORITY||Least Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.545||0.0855|TWO_SIDED|95.0|-2.01|0.13|||Mixed Models Analysis|||The WOMAC B least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.13|-2.01|0.0855
74085022|NCT03429049|147723648|SUPERIORITY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|4.096||0.055|TWO_SIDED|95.0|-15.86|0.26|||Mixed Models Analysis|||The WOMAC C least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.26|-15.86|0.0550
74085023|NCT00653159|147723669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4003|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject completed the final study visit at 6 months. Under the null hypothesis, study completion rates are similar for both IUD types.||||0.4003
73963391|NCT02409667|147462487|SUPERIORITY||LSM estimate|-0.09||||0.1073|TWO_SIDED|95.0|-0.19|0.02|||ANCOVA|||Week 32||0.02|-0.19|0.1073
73963392|NCT02409667|147462487|SUPERIORITY||LSM estimate|-0.24||||0.0001|TWO_SIDED|95.0|-0.37|-0.12|||ANCOVA|||Week 36||-0.12|-0.37|0.0001
73963393|NCT02409667|147462487|SUPERIORITY||LSM estimate|-0.25||||0.0005|TWO_SIDED|95.0|-0.38|-0.11|||ANCOVA|||Week 40||-0.11|-0.38|0.0005
73963394|NCT02409667|147462487|SUPERIORITY||LSM estimate|-0.3||||0.0001|TWO_SIDED|95.0|-0.45|-0.15|||ANCOVA|||Week 44||-0.15|-0.45|0.0001
73963395|NCT02409667|147462487|SUPERIORITY||LSM estimate|-0.49||||0|TWO_SIDED|95.0|-0.7|-0.27|||ANCOVA|||Week 48||-0.27|-0.70|0.0000
73963396|NCT02409667|147462487|SUPERIORITY||LSM mean|-0.59||||0|TWO_SIDED|95.0|-0.81|-0.36|||ANCOVA|||||-0.36|-0.81|0.0000
73963397|NCT02409667|147462488|SUPERIORITY||LSM estimate|0.4||||0.174|TWO_SIDED|95.0|-0.18|0.99|||ANCOVA|||Week 28||0.99|-0.18|0.1740
73963398|NCT02409667|147462488|SUPERIORITY||LSM estimate|0.79||||0.0287|TWO_SIDED|95.0|0.08|1.5|||ANCOVA|||Week 32||1.50|0.08|0.0287
73963399|NCT02409667|147462488|SUPERIORITY||LSM estimate|0.62||||0.1202|TWO_SIDED|95.0|-0.16|1.41|||ANCOVA|||Week 36||1.41|-0.16|0.1202
73963400|NCT02409667|147462488|SUPERIORITY||LSM estimate|0.75||||0.1157|TWO_SIDED|95.0|-0.19|1.68|||ANCOVA|||Week 40||1.68|-0.19|0.1157
73963401|NCT02409667|147462488|SUPERIORITY||LSM estimate|0.54||||0.3189|TWO_SIDED|95.0|-0.52|1.59|||ANCOVA|||Week 44||1.59|-0.52|0.3189
73963402|NCT02409667|147462488|SUPERIORITY||LSM estimate|1.17||||0.024|TWO_SIDED|95.0|0.16|2.18|||ANCOVA|||Week 48||2.18|0.16|0.0240
73963403|NCT02409667|147462488|SUPERIORITY||LSM estimate|1.47||||0.009|TWO_SIDED|95.0|0.37|2.57|||ANCOVA|||Week 52||2.57|0.37|0.0090
73963404|NCT02409667|147462489|SUPERIORITY||LSM estimate|-0.62||||0.0001|TWO_SIDED|95.0|-0.93|-0.31|||ANCOVA|||||-0.31|-0.93|0.0001
73963405|NCT02409667|147462490|SUPERIORITY||LSM estimate|1.17||||0.0675|TWO_SIDED|95.0|-0.09|2.42|||ANCOVA|||||2.42|-0.09|0.0675
73963406|NCT02409667|147462491|SUPERIORITY||LSM estimate|-0.97||||0.2101|TWO_SIDED|95.0|-2.48|0.55|||ANCOVA|||Absenteeism||0.55|-2.48|0.2101
73963407|NCT02409667|147462491|SUPERIORITY||LSM estimate|-0.67||||0.2971|TWO_SIDED|95.0|-1.93|0.59|||ANCOVA|||Presenteeism||0.59|-1.93|0.2971
73963408|NCT02409667|147462491|SUPERIORITY||LSM estimate|-0.61||||0.5499|TWO_SIDED|95.0|-2.59|1.38|||ANCOVA|||Total activity impairment||1.38|-2.59|0.5499
73963409|NCT02409667|147462491|SUPERIORITY||LSM estimate|-1.08||||0.0758|TWO_SIDED|95.0|-2.28|0.11|||ANCOVA|||||0.11|-2.28|0.0758
73963410|NCT02409667|147462492|SUPERIORITY||LSM estimate|1.2||||0.4156|TWO_SIDED|95.0|-1.71|4.11|||ANCOVA|||Absenteeism||4.11|-1.71|0.4156
73963411|NCT02409667|147462492|SUPERIORITY||LSM estimate|0.63||||0.8619|TWO_SIDED|95.0|-6.59|7.85|||ANCOVA|||Presenteeism||7.85|-6.59|0.8619
73963412|NCT02409667|147462492|SUPERIORITY||LSM estimate|-0.61||||0.6139|TWO_SIDED|95.0|-6.31|10.61|||ANCOVA|||Total activity impairment||10.61|-6.31|0.6139
73963413|NCT02409667|147462492|SUPERIORITY||LSM estimate|1.7||||0.5674|TWO_SIDED|95.0|-4.16|7.56|||ANCOVA|||Work productivity loss||7.56|-4.16|0.5674
73963414|NCT02409667|147462493|SUPERIORITY||LSM estimate|-0.13||||0.1219|TWO_SIDED|95.0|-0.3|0.04|||ANCOVA|||Pain||0.04|-0.30|0.1219
73963415|NCT02409667|147462493|SUPERIORITY||LSM estimate|-0.38||||0.0001|TWO_SIDED|95.0|-0.57|-0.18|||ANCOVA|||Itching||-0.18|-0.57|0.0001
73963416|NCT02409667|147462493|SUPERIORITY||LSM estimate|-0.31||||0.0003|TWO_SIDED|95.0|-0.48|-0.14|||ANCOVA|||Scaling||-0.14|-0.48|0.0003
73963417|NCT02409667|147462494|SUPERIORITY||LSM estimate|0.17||||0.6457|TWO_SIDED|95.0|-0.57|0.92|||ANCOVA|||Pain||0.92|-0.57|0.6457
73963418|NCT02409667|147462494|SUPERIORITY||LSM estimate|0.19||||0.6136|TWO_SIDED|95.0|-0.56|0.94|||ANCOVA|||Itching||0.94|-0.56|0.6136
73963419|NCT02409667|147462494|SUPERIORITY||LSM estimate|0.75||||0.0203|TWO_SIDED|95.0|0.12|1.39|||ANCOVA|||Scaling||1.39|0.12|0.0203
73963420|NCT02409667|147462495|SUPERIORITY||LSM estimate|2.22||||0.0027|TWO_SIDED|95.0|0.77|3.68|||ANCOVA|||||3.68|0.77|0.0027
73963421|NCT02409667|147462496|SUPERIORITY||LSM estimate|-2.31||||0.2823|TWO_SIDED|95.0|-6.55|1.92|||ANCOVA|||||1.92|-6.55|0.2823
73963422|NCT02409667|147462497|SUPERIORITY||LSM estimate|0.01||||0.0861|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|||Germany||0.02|-0.00|0.0861
73963423|NCT02409667|147462497|SUPERIORITY||LSM estimate|0.02||||0.0117|TWO_SIDED|95.0|0.0|0.04|||ANCOVA|||UK||0.04|0.00|0.0117
73963424|NCT02409667|147462498|SUPERIORITY||LSM estimate|-0.02||||0.1852|TWO_SIDED|95.0|-0.05|0.01|||ANCOVA|||Germany||0.01|-0.05|0.1852
73963425|NCT02409667|147462498|SUPERIORITY||LSM estimate|-0.03||||0.2203|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||UK||0.02|-0.07|0.2203
74025432|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.84||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.||||0.83
74025433|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|-0.43||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.||||0.96
74085024|NCT00653159|147723670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4136|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced heavy bleeding. Under the null hypothesis, heavy bleeding rates are similar for both IUD types.||||0.4136
74085025|NCT00653159|147723671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4783|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject became pregnant within 6 months of IUD insertion. Under the null hypothesis, pregnancy rates are similar for both IUD types.||||0.4783
73855669|NCT01191736|147258150|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|Null hypothesis: the proportions within the seven arms are equal.||Comparison of proportions of subjects who assessed responsiveness||||.05
73855670|NCT03703817|147258153|SUPERIORITY|Effectiveness: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.3648|||||||Linear mixed model|||||||0.3648
73855671|NCT03703817|147258153|SUPERIORITY|Side effect: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1395|||||||Conditional logistic regression|||||||0.1395
73855672|NCT03703817|147258153|SUPERIORITY|Convenience: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.0349|||||||Linear mixed model|||||||0.0349
73855673|NCT03703817|147258153|SUPERIORITY|Global satisfaction: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1546|||||||Linear mixed model|||||||0.1546
73855674|NCT03703817|147258154|SUPERIORITY|Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1602|||||||Conditional logistic regression model|||||||0.1602
73855675|NCT03703817|147258155|SUPERIORITY|Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.9921|||||||Linear mixed model|||||||0.9921
73855676|NCT05248997|147258163|SUPERIORITY||Difference in least square mean|-0.09||||0.7782|TWO_SIDED|95.0|-0.71|0.53||LM included baseline value as covariate,\& fixed effects for treatment group,stratification factor,scheduled time point(TP),TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.53|-0.71|0.7782
73855677|NCT05248997|147258164|SUPERIORITY||Difference in least square mean|-0.29||||0.7079|TWO_SIDED|95.0|-1.83|1.24||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||1.24|-1.83|0.7079
73855678|NCT05248997|147258165|SUPERIORITY||Difference in least square mean|-0.23||||0.4398|TWO_SIDED|95.0|-0.81|0.36||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.36|-0.81|0.4398
73855679|NCT05248997|147258166|SUPERIORITY||Difference in least square mean|0.04||||0.889|TWO_SIDED|95.0|-0.51|0.59||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.59|-0.51|0.8890
73855680|NCT05248997|147258167|SUPERIORITY||Percentage difference|3.8||||0.6412|TWO_SIDED|95.0|-12.1|19.7|||Mantel-Haenszel|Stratified by presence of nasal polyps at randomization with Mantel-Haenszel risk estimation.||||19.7|-12.1|0.6412
73855681|NCT05248997|147258168|SUPERIORITY||Percentage difference|-2.7||||0.5001|TWO_SIDED|95.0|-10.6|5.2|||Mantel-Haenszel|Stratified by presence of nasal polyps at randomization with Mantel-Haenszel risk estimation.||||5.2|-10.6|0.5001
73855682|NCT04262882|147258181|SUPERIORITY||Odds Ratio (OR)|1.67||||0.2|TWO_SIDED|95.0|0.77|3.64|||Regression, Logistic|Adjusted for age and religion. Analysis in GEE to account for dependence in repeated, dyadic data.|Reference group is the comparator arm|||3.64|0.77|0.20
73855683|NCT04262882|147258184|SUPERIORITY||Wald Chi-Square|35.2|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints.|||||<0.001
73855684|NCT04262882|147258184|SUPERIORITY||unstandardized beta|0.41|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73905646|NCT05419908|147342041|SUPERIORITY||Percentage Difference|61.5|||<|0.001||95.0|45.4|77.55||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||77.55|45.40|<0.001
73855685|NCT04262882|147258184|SUPERIORITY||unstandardized beta|0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73855686|NCT04262882|147258185|SUPERIORITY||Wald Chi-Square|64.53|||<|0.001|TWO_SIDED|||||Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints.||"Tests of significance for each follow-up time point:~7-months: unstandardized beta=1.08, standard error=0.14, p \< 0.001; 10-months: unstandardized beta=0.79, standard error=0.14, p \< 0.001"|||<0.001
73855687|NCT04262882|147258185|SUPERIORITY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73855688|NCT04262882|147258185|SUPERIORITY||unstandardized beta|0.79|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73855689|NCT04262882|147258186|SUPERIORITY||Wald Chi-Square|23.89|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73855690|NCT04262882|147258186|SUPERIORITY||unstandardized beta|0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||P value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73855691|NCT04262882|147258186|SUPERIORITY||unstandardized beta|0.19|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73855692|NCT04262882|147258187|SUPERIORITY||Wald Chi-Square|48.26|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models were run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73855693|NCT04262882|147258187|SUPERIORITY||unstandardized beta|0.68|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Cox|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73855694|NCT04262882|147258187|SUPERIORITY||unstandardized beta|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.04
73855695|NCT04262882|147258188|SUPERIORITY||Wald Chi-Square|9.87||||0.007|TWO_SIDED|||||Arm\*Time p value for 10-months follow up overall.|Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.007
73855696|NCT04262882|147258188|SUPERIORITY|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|unstandardized beta|-0.16|STANDARD_ERROR_OF_MEAN|0.32||0.6|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|||||||0.60
73855697|NCT04262882|147258188|SUPERIORITY||Slope|-0.53|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.07
73855698|NCT04262882|147258189|SUPERIORITY||Wald Chi-Square|10.42||||0.005|TWO_SIDED||||||Regression, Logistic|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.005
73855699|NCT04262882|147258189|SUPERIORITY||Odds Ratio (OR)|1.36||||0.05|TWO_SIDED|95.0|0.99|1.85||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Logistic|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||1.85|0.99|0.05
73855700|NCT04262882|147258189|SUPERIORITY||Odds Ratio (OR)|0.96||||0.71|TWO_SIDED|95.0|0.75|1.22||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Logistic|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||1.22|0.75|0.71
73963426|NCT00774852|147462513|SUPERIORITY_OR_OTHER|||||||0.85|||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.85
73963427|NCT00774852|147462514|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.99
73963428|NCT00774852|147462515|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.54
73963429|NCT00774852|147462515|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.72
73963430|NCT00774852|147462516|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.54
73963431|NCT00774852|147462521|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.||||>0.99
73963432|NCT00774852|147462522|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.||||>0.99
73963433|NCT00774852|147462524|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with renal flare||||0.23
73963434|NCT00774852|147462524|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with renal flare||||0.61
73963435|NCT00774852|147462524|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with at least one non-renal flare||||>0.99
73963436|NCT00774852|147462524|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with at least one non-renal flare||||>0.99
73963437|NCT00774852|147462529|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA|||||||0.79
73963438|NCT00774852|147462529|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA|||||||0.74
73963439|NCT00774852|147462530|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups for Pneumococcal vaccines||||0.43
73963440|NCT00774852|147462530|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups for Tetanus Toxoid vaccines||||0.99
74025434|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.07||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.||||0.96
74085026|NCT00653159|147723672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2174|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced expulsion of the IUD. Under the null hypothesis, expulsion rates are similar for both IUD types.||||0.2174
74085027|NCT00653159|147723673|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|Two-sided test||"Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject reported being satisfied (happy or very happy) at the 6 month study visit. Under the null hypothesis, satisfaction rates are similar for both IUD types."||||1.0000
73855701|NCT04262882|147258190|SUPERIORITY||Wald Chi-Square|13.4||||0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
73855702|NCT04262882|147258190|SUPERIORITY||unstandardized beta|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.07
73855703|NCT04262882|147258190|SUPERIORITY||unstandardized beta|0.21|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73855704|NCT04262882|147258191|SUPERIORITY||Wald Chi-Square|78.81||||0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
73855705|NCT04262882|147258191|SUPERIORITY||unstandardized beta|1.19|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73855706|NCT04262882|147258191|SUPERIORITY||unstandardized beta|1.65|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
73855707|NCT04262882|147258192|SUPERIORITY||Wald Chi-Square|19.46|||<|0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73855708|NCT04262882|147258192|SUPERIORITY||unstandardized beta|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.008|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.008
73963441|NCT01827787|147462543|SUPERIORITY|||||||0.42|||||||Fisher Exact|||"Using a one sample binomial design, with 45 patients there was 90% power to detect a null hypothesis 30% overall response rate (historical control) versus an alternative hypothesis of 53% overall response rate assuming a two-sided 10% alpha.~Of note, cohort 2: TNBC did not fully accrue 45 patients so a testing was not done."||||0.42
73963442|NCT03482635|147462552|OTHER||Risk Difference (RD)|0.042|||||TWO_SIDED|95.0|-0.105|0.202|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.202|-0.105|
73963443|NCT03482635|147462552|OTHER||Risk Difference (RD)|0.087|||||TWO_SIDED|95.0|-0.069|0.268|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.268|-0.069|
73963444|NCT03482635|147462552|OTHER||Risk Difference (RD)|0.071|||||TWO_SIDED|95.0|-0.081|0.226|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.226|-0.081|
73963445|NCT03482635|147462553|OTHER||Risk Difference (RD)|-0.051|||||TWO_SIDED|95.0|-0.276|0.176|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.176|-0.276|
73963446|NCT03482635|147462553|OTHER||Risk Difference (RD)|0.043|||||TWO_SIDED|95.0|-0.199|0.28|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.280|-0.199|
73905647|NCT05419908|147342041|SUPERIORITY||Percentage Difference|43.1|||<|0.001|TWO_SIDED|95.0|23.53|62.69||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||62.69|23.53|<0.001
73905648|NCT05419908|147342041|SUPERIORITY||Percentage Difference|52.5|||<|0.001||95.0|33.92|71.08||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||71.08|33.92|<0.001
73905649|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.53|||<|0.001|TWO_SIDED|95.0|-3.45|-1.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Work||-1.60|-3.45|<0.001
73905650|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.29|||<|0.001|TWO_SIDED|95.0|-3.15|-1.42||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Work||-1.42|-3.15|<0.001
73905651|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.11|||<|0.001|TWO_SIDED|95.0|-3.03|-1.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Work||-1.20|-3.03|<0.001
73905652|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-3.19|-1.46||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Social Activities||-1.46|-3.19|<0.001
73905653|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.34|||<|0.001|TWO_SIDED|95.0|-3.21|-1.47||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Social Activties||-1.47|-3.21|<0.001
73905654|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.19|||<|0.001|TWO_SIDED|95.0|-3.09|-1.29||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Social Activties||-1.29|-3.09|<0.001
73905655|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.15|||<|0.001|TWO_SIDED|95.0|-2.99|-1.31||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Leisure Activities||-1.31|-2.99|<0.001
73905656|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.37|||<|0.001|TWO_SIDED|95.0|-3.19|-1.55||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Leisure Activties||-1.55|-3.19|<0.001
73905657|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.64||||0.002|TWO_SIDED|95.0|-2.66|-0.62||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Leisure Activties||-0.62|-2.66|0.002
73905658|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.93|||<|0.001|TWO_SIDED|95.0|-4.08|-1.78||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Sleep||-1.78|-4.08|<0.001
73963447|NCT03482635|147462553|OTHER||Risk Difference (RD)|0.033|||||TWO_SIDED|95.0|-0.204|0.252|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.252|-0.204|
73855709|NCT04262882|147258192|SUPERIORITY||unstandardized beta|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
73905659|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.71|||<|0.001|TWO_SIDED|95.0|-3.86|-1.57||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Sleep||-1.57|-3.86|<0.001
73905660|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.61|||<|0.001|TWO_SIDED|95.0|-3.67|-1.54||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Sleep||-1.54|-3.67|<0.001
73905661|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.74|||<|0.001|TWO_SIDED|95.0|-2.67|-0.81||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Mood||-0.81|-2.67|<0.001
73905662|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.12|||<|0.001|TWO_SIDED|95.0|-3.09|-1.16||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Mood||-1.16|-3.09|<0.001
73905663|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.79|||<|0.001|TWO_SIDED|95.0|-2.69|-0.88||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Mood||-0.88|-2.69|<0.001
73905664|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.86|-0.97||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Concentration||-0.97|-2.86|<0.001
73963448|NCT03482635|147462554|OTHER||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.072|0.258|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.258|-0.072|
73855710|NCT03268954|147258202|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.557|TWO_SIDED|95.0|0.757|1.238|||Log Rank|P-value comparing EFS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.|HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|||1.238|0.757|=0.557
73855711|NCT03268954|147258203|SUPERIORITY|P-value comparing OS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.|Hazard Ratio (HR)|0.881|||=|0.181|TWO_SIDED|95.0|0.697|1.115|||Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1: longer survival time in combination arm than azacitidine arm.|Overall Survival (OS)||1.115|0.697|=0.181
74085028|NCT00109837|147723679|SUPERIORITY_OR_OTHER||Proportion in 1-year CCR|0.36|STANDARD_DEVIATION|0.06|||ONE_SIDED|95.0|0.25|||||||The regimen would be of no further interest if the true 1-year continuous complete remission (CCR) rate was less than 45% (null). Sample size was chosen for an alternative of 65%, power of 92% and type-1 error of 4.6%.|||0.25|
74085029|NCT01848210|147723681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.65||||0.531|TWO_SIDED|95.0|-19.81|10.51|||Regression, Linear|||||10.51|-19.81|0.531
73905665|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.23|||<|0.001|TWO_SIDED|94.0|-3.21|-1.25||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Concentration||-1.25|-3.21|<0.001
73905666|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.91|-0.88||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Concentration||-0.88|-2.91|<0.001
73905667|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.33||||0.003|TWO_SIDED|95.0|-2.2|-0.46||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Relations With Others||-0.46|-2.20|0.003
73905668|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.8|-0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Relations With others||-0.90|-2.80|<0.001
73905669|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.72|||<|0.001|TWO_SIDED|95.0|-2.66|-0.77||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Relations With Others||-0.77|-2.66|<0.001
73905670|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.06||||0.081|TWO_SIDED|95.0|-2.25|0.13||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Sexuality||0.13|-2.25|0.081
73905671|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.4||||0.05|TWO_SIDED|95.0|-2.8|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Sexuality||0.00|-2.80|0.050
73905672|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.51||||0.026|TWO_SIDED|95.0|-2.84|-0.19||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Sexuality||-0.19|-2.84|0.026
73905673|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.51|-0.79||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Enjoyment of Life||-0.79|-2.51|<0.001
73905674|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.07|||<|0.001|TWO_SIDED|95.0|-2.97|-1.18||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Enjoyment of Life||-1.18|-2.97|<0.001
73905675|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.88|-0.78||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Enjoyment of Life||-0.78|-2.88|<0.001
73905676|NCT05419908|147342042|SUPERIORITY||LSMean difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.86|-0.97||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week4: Overall Quality of Life||-0.97|-2.86|<0.001
74085030|NCT00381849|147723685|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on placebo.||||0.32
73905677|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.51|||<|0.001|TWO_SIDED|95.0|-3.41|-1.61||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Overall Quality of Life||-1.61|-3.41|<0.001
73905678|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.36|||<|0.001|TWO_SIDED|95.0|-3.31|-1.41||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Overall Quality of Life||-1.41|-3.31|<0.001
73905679|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.98|||<|0.001|TWO_SIDED|95.0|-2.73|-1.23||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Overall Mean Score||-1.23|-2.73|<0.001
73905680|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-2.21|||<|0.001|TWO_SIDED|95.0|-3.02|-1.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Overall Mean Score||-1.40|-3.02|<0.001
73905681|NCT05419908|147342042|SUPERIORITY||LSMean Difference|-1.98|||<|0.001|TWO_SIDED|95.0|-2.83|-1.13||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Overall Mean Score||-1.13|-2.83|<0.001
73963449|NCT03482635|147462554|OTHER||Risk Difference (RD)|0.087|||||TWO_SIDED|95.0|-0.069|0.268|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.268|-0.069|
73963450|NCT03482635|147462554|OTHER||Risk Difference (RD)|0.071|||||TWO_SIDED|95.0|-0.081|0.226|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.226|-0.081|
73963451|NCT03482635|147462555|OTHER||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.072|0.258|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.258|-0.072|
73963452|NCT03482635|147462555|OTHER||Risk Difference (RD)|0.043|||||TWO_SIDED|95.0|-0.104|0.21|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.210|-0.104|
73963453|NCT03482635|147462555|OTHER||Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|-0.11|0.177|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.177|-0.110|
74085031|NCT00381849|147723685|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on cystone.||||0.23
74025435|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.23||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model|||The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|||0.96
74025436|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.77||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.||||0.96
74085032|NCT00381849|147723685|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.41
74085033|NCT00381849|147723685|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 46 weeks' treatment on cystone.||||0.32
73905682|NCT05419908|147342043|SUPERIORITY||LSMean Difference|1.375|||<|0.001|TWO_SIDED|95.0|0.651|2.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Getting to Sleep||2.100|0.651|<0.001
73905683|NCT05419908|147342043|SUPERIORITY||LSMean Difference|1.166|||<|0.001|TWO_SIDED|95.0|0.505|1.827||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Getting to Sleep||1.827|0.505|<0.001
73905684|NCT05419908|147342043|SUPERIORITY||LSMean Difference|0.895||||0.014|TWO_SIDED|95.0|0.19|1.599||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Getting to Sleep||1.599|0.190|0.014
73905685|NCT05419908|147342043|SUPERIORITY||LSMean Difference|2.423|||<|0.001|TWO_SIDED|95.0|1.308|3.539||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Quality of Sleep||3.539|1.308|<0.001
73905686|NCT05419908|147342043|SUPERIORITY||LSMean Difference|2.291|||<|0.001|TWO_SIDED|95.0|1.31|3.251||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Quality of Sleep||3.251|1.31|<0.001
73905687|NCT05419908|147342043|SUPERIORITY||LSMean Difference|2.433|||<|0.001|TWO_SIDED|95.0|1.334|3.532||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Quality of Sleep||3.532|1.334|<0.001
73905688|NCT05419908|147342043|SUPERIORITY||LSMean Difference|0.877||||0.059|TWO_SIDED|95.0|-0.034|1.789||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Awake Following Sleep||1.789|-0.034|0.059
73905689|NCT05419908|147342043|SUPERIORITY||LSMean Difference|1.457||||0.001|TWO_SIDED|95.0|0.579|2.335||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Awake Following Sleep||2.335|0.579|0.001
73905690|NCT05419908|147342043|SUPERIORITY||LSMean Difference|1.113||||0.031|TWO_SIDED|95.0|0.107|2.12||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Awake Following Sleep||2.120|0.107|0.031
73905691|NCT05419908|147342043|SUPERIORITY||LSMean Difference|1.203||||0.008|TWO_SIDED|95.0|0.317|2.088||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Behaviour Following Wakening||2.088|0.317|0.008
73905692|NCT05419908|147342043|SUPERIORITY||LSMean Difference|1.597||||0.001|TWO_SIDED|95.0|0.639|2.556||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Behaviour Following Wakening||2.556|0.639|0.001
73905693|NCT05419908|147342043|SUPERIORITY||LSMean Difference|0.842||||0.084|TWO_SIDED|95.0|-0.116|1.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Behaviour Following Sleep||1.800|-0.116|0.084
73905694|NCT05419908|147342044|SUPERIORITY||LSMean Difference|0.0||||0.881|TWO_SIDED|95.0|-0.3|0.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Loss of Interest in Sex||0.3|-0.3|0.881
73905695|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-0.2||||0.383|TWO_SIDED|95.0|-0.6|0.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Loss of Interest in Sex||0.2|-0.6|0.383
73905696|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-0.2||||0.301|TWO_SIDED|95.0|-0.6|0.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Loss of Interest in Sex||0.2|-0.6|0.301
73905697|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-2.5||||0.02|TWO_SIDED|95.0|-4.5|-0.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Psychological||-0.4|-4.5|0.020
73905698|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-3.3||||0.003|TWO_SIDED|95.0|-5.4|-1.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Psychological||-1.2|-5.4|0.003
74085034|NCT00381849|147723686|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on placebo.||||0.49
73855712|NCT03268954|147258208|SUPERIORITY||Hazard Ratio (HR)|1.037|||=|0.562|TWO_SIDED|95.0|0.66|1.63||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR MDS Participants||1.630|0.660|=0.562
73855713|NCT03268954|147258208|SUPERIORITY||Hazard Ratio (HR)|1.512|||=|0.603|TWO_SIDED|95.0|0.068|33.773||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR CMML Participants||33.773|0.068|=0.603
73855714|NCT03268954|147258208|SUPERIORITY||Hazard Ratio (HR)|1.034|||=|0.558|TWO_SIDED|95.0|0.663|1.61||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML/MDS.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR MDS/CMML Participants||1.610|0.663|=0.558
73855715|NCT03268954|147258209|SUPERIORITY||Absolute Rate Difference|-4.18|||=|0.374|TWO_SIDED|95.0|-13.18|4.83||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants With Complete Remission (CR) and CR+Complete Remission with Incomplete Blood Count Recovery (CRi)||4.83|-13.18|=0.374
73855716|NCT03268954|147258214|SUPERIORITY||Absolute Rate Difference|-4.67|||=|0.329|TWO_SIDED|95.0|-13.72|4.39||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, Revised International Prognostic Scoring System (IPSS-R) risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants with OR||4.39|-13.72|=0.329
73855717|NCT03268954|147258215|SUPERIORITY||Absolute Rate Difference|-0.44|||=|0.891|TWO_SIDED|95.0|-10.03|9.15||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants with OR2||9.15|-10.03|=0.891
73855718|NCT03268954|147258216|SUPERIORITY||Hazard Ratio (HR)|0.679|||=|0.072|TWO_SIDED|95.0|0.402|1.146|||Log Rank|P-value was based on 1-sided log-rank test stratified by low-blast AML,IPSS-R risk groups of very high,high,or intermediate for HR MDS/CMML.|Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of CR||1.146|0.402|=0.072
73855719|NCT03268954|147258217|SUPERIORITY||Hazard Ratio (HR)|0.846|||=|0.373|TWO_SIDED|95.0|0.306|2.339||P-value comparing duration of CR+CRi between treatment groups was based on 1-sided unstratified log-rank.|Log Rank||Hazard ratio was based on an unadjusted unstratified Cox proportional hazard regression model with treatment as a factor in the model.|Duration of Complete Remission + Complete Remission with Incomplete Blood Count Recovery (CRi)||2.339|0.306|=0.373
73855720|NCT03268954|147258218|SUPERIORITY||Hazard Ratio (HR)|0.889|||=|0.32|TWO_SIDED|95.0|0.542|1.458||P-value comparing duration of PR or better response between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of Overall Response (OR)||1.458|0.542|=0.320
73855721|NCT03268954|147258219|SUPERIORITY||Hazard Ratio (HR)|0.796|||=|0.151|TWO_SIDED|95.0|0.514|1.231||P-value comparing duration of overall response 2 between treatment groups was based on 1-sided log-rank test stratified by low blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of Overall Response 2 (OR2)||1.231|0.514|=0.151
73855722|NCT03268954|147258220|SUPERIORITY||Absolute Rate Difference|3.27|||=|0.573|TWO_SIDED|95.0|-9.02|15.55||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With RBC-transfusion Independence||15.55|-9.02|=0.573
73855723|NCT03268954|147258220|SUPERIORITY||Absolute Rate Difference|-3.43|||=|0.477|TWO_SIDED|95.0|-25.84|18.97||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With Platelet-transfusion Independence||18.97|-25.84|=0.477
73905699|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-3.1||||0.005|TWO_SIDED|95.0|-5.2|-1.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Psychological||-1.0|-5.2|0.005
73905700|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-0.2||||0.732|TWO_SIDED|95.0|-1.2|0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Physical||0.9|-1.2|0.732
73905701|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-0.7||||0.282|TWO_SIDED|95.0|-1.9|0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Physical||0.6|-1.9|0.282
73905702|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-0.6||||0.254|TWO_SIDED|95.0|-1.7|0.5||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Physical||0.5|-1.7|0.254
73971058|NCT02969707|147482300|SUPERIORITY|||||||0.728|||||||ANCOVA|||Standard ANCOVA testing whether the Post-TMS E/I relative to creatine is predicted for each subject by the intervention (Active / Sham) while covarying for the Pre-TMS E/I ratio relative to creatine.||||0.728
73905703|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.7|-1.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Vasomotor||-1.4|-2.7|<0.001
73905704|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-1.8|||<|0.001|TWO_SIDED|95.0|-2.4|-1.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Vasomotor||-1.1|-2.4|<0.001
73905705|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.6|-1.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Vasomotor||-1.3|-2.6|<0.001
73905706|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-4.6||||0.013|TWO_SIDED|95.0|-8.2|-1.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Total Symptom Score||-1.0|-8.2|0.013
73905707|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-6.9|||<|0.001|TWO_SIDED|95.0|-10.7|-3.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Total Symptom Score||-3.1|-10.7|<0.001
73905708|NCT05419908|147342044|SUPERIORITY||LSMean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-9.9|-2.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Total Symptom Score||-2.8|-9.9|<0.001
73905709|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.7|-0.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Work/School||-0.8|-2.7|<0.001
73905710|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.8|-1.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Work/School||-1.3|-2.8|<0.001
73905711|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.5|-0.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Work/School||-0.8|-2.5|<0.001
73905712|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-2.2|-0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Social Life||-0.6|-2.2|<0.001
73905713|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Social Life||-1.1|-2.7|<0.001
73905714|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.4|-0.7||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Social Life||-0.7|-2.4|<0.001
73905715|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-1.3||||0.005|TWO_SIDED|95.0|-2.2|-0.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Family Life/Home Responsibilities||-0.4|-2.2|0.005
73905716|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.5|-0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Family Life/Home Responsibilities||-0.9|-2.5|<0.001
73905717|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.4|-0.7||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Family Life/Home Responsibilities||-0.7|-2.4|<0.001
73905718|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-4.4|||<|0.001|TWO_SIDED|95.0|-6.9|-2.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Global Functional Impairment||-2.0|-6.9|<0.001
73905719|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-5.8|||<|0.001|TWO_SIDED|95.0|-8.0|-3.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Global Functional Impairment||-3.6|-8.0|<0.001
73905720|NCT05419908|147342045|SUPERIORITY||LSMean Difference|-5.3|||<|0.001|TWO_SIDED|95.0|-7.8|-2.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Global Functional Impairment||-2.8|-7.8|<0.001
73905721|NCT05419908|147342046|SUPERIORITY||LSMean difference|0.0||||0.936|TWO_SIDED|95.0|-0.5|0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Days Lost||0.6|-0.5|0.936
73905722|NCT05419908|147342046|SUPERIORITY||LSMean difference|0.0||||0.884|TWO_SIDED|95.0|-0.1|0.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Days Lost||0.1|-0.1|0.884
73905723|NCT05419908|147342046|SUPERIORITY||LSMean difference|-0.2||||0.124|TWO_SIDED|95.0|-0.4|0.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Days Lost||0.1|-0.4|0.124
73905724|NCT05419908|147342046|SUPERIORITY||LSMean difference|-0.9||||0.052|TWO_SIDED|95.0|-1.8|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Days Unproductive||0.0|-1.8|0.052
73905725|NCT05419908|147342046|SUPERIORITY||LSMean difference|-0.9||||0.06||95.0|-1.7|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Days Unproductive||0.0|-1.7|0.060
73905726|NCT05419908|147342046|SUPERIORITY||LSMean difference|-0.8||||0.049|TWO_SIDED|95.0|-1.7|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Days Unproductive||0.0|-1.7|0.049
73930928|NCT00280566|147391709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0013|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0013
73930929|NCT00280566|147391709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.1167|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1167
73930930|NCT00280566|147391709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0188|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0188
73963454|NCT03482635|147462556|OTHER||Difference of adjusted means|-0.3|STANDARD_ERROR_OF_MEAN|10.7||0.9776|TWO_SIDED|95.0|-21.6|21.0|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.||21.0|-21.6|0.9776
73971059|NCT02969707|147482300|SUPERIORITY|||||||0.72|||||||ANCOVA|||Standard ANCOVA testing whether the Post-TMS E/I relative to water is predicted for each subject by the intervention (Active / Sham) while covarying for the Pre-TMS E/I ratio relative to water.||||0.720
73930931|NCT00280566|147391709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.3413|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3413
73930932|NCT00280566|147391709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.276|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2760
73971060|NCT05670587|147482331|OTHER||gMean ratio at Week 4|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric Coefficient of variation (gCV) = 84.59%"|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 4.||1.18|0.76|
73971061|NCT05670587|147482331|OTHER||gMean ratio at Week 8|0.84|||||TWO_SIDED|95.0|0.64|1.11|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric coefficient of variation (gCV) = 115.62%"|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 8.||1.11|0.64|
73971062|NCT05670587|147482331|OTHER||gMean ratio at Day 82|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric coefficient of variation (gCV) = 100.02%."|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Day 82.||1.29|0.75|
73971063|NCT03084536|147482382|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
73971064|NCT03084536|147482383|SUPERIORITY|||||||0.67|||||||Kruskal-Wallis|||||||0.67
73971065|NCT03084536|147482384|SUPERIORITY|||||||0.53|||||||Kruskal-Wallis|||||||0.53
73971066|NCT03084536|147482385|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.44
73971067|NCT03084536|147482386|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||0.88
73971068|NCT04285515|147482433|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-7.6|-3.84|||Mixed Effects Model for Repeated Measure|||||-3.84|-7.60|<0.0001
73971069|NCT04285515|147482434|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.33|<|0.0001|TWO_SIDED|95.0|-8.29|-3.05|||Mixed Effects Model for Repeated Measure|||||-3.05|-8.29|<0.0001
73971070|NCT04285515|147482435|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|1.35|<|0.0001|TWO_SIDED|95.0|-8.61|-3.29|||Mixed Effects Model for Repeated Measure|||||-3.29|-8.61|<0.0001
73971071|NCT04285515|147482436|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-7.25|-3.88|||Mixed Effects Model for Repeated Measure|||||-3.88|-7.25|<0.0001
73971072|NCT04285515|147482437|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.81|-0.39|||Mixed Effects Model of Repeated Measure|||||-0.39|-0.81|<0.0001
73905727|NCT04622735|147342093|SUPERIORITY|||||||0.0031|||||||Mixed Models Analysis|||||||0.0031
73905728|NCT04622735|147342093|SUPERIORITY|||||||0.6787|||||||Mixed Models Analysis|||||||0.6787
73905729|NCT00994318|147342120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.026|TWO_SIDED|95.0|0.44|0.95|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~1. FCM (high ferritin target) compared with oral iron.~2. FCM (high ferritin target) compared with FCM (low ferritin target).~3. FCM (low ferritin target) compared with oral iron."||0.95|0.44|0.026
73905730|NCT00994318|147342120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.082|TWO_SIDED|95.0|0.45|1.05|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400-600mcg/L) compared with FCM targeting low ferritin level (100 - 200 mcg/L).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~1. FCM (high ferritin target) compared with oral iron.~2. FCM (high ferritin target) compared with FCM (low ferritin target).~3. FCM (low ferritin target) compared with oral iron."||1.05|0.45|0.082
73905731|NCT00994318|147342120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.02|TWO_SIDED|95.0|0.39|0.93|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management without taking into account the Hb trigger.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."||0.93|0.39|0.020
73905732|NCT00994318|147342120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.008|TWO_SIDED|95.0|0.43|0.88|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."||0.88|0.43|0.008
73963455|NCT03482635|147462556|OTHER||Difference of adjusted means|1.4|STANDARD_ERROR_OF_MEAN|10.6||0.894|TWO_SIDED|95.0|-19.6|22.4|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.||22.4|-19.6|0.8940
73963456|NCT03482635|147462556|OTHER||Difference of adjusted means|1.0|STANDARD_ERROR_OF_MEAN|10.6||0.9241|TWO_SIDED|95.0|-20.0|22.1|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements||22.1|-20.0|0.9241
73963457|NCT04870645|147462578|OTHER||||||<|0.05|||||||Statistical Significance|||||||< 0.05
73905733|NCT00994318|147342120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.12|TWO_SIDED|95.0|0.45|1.1|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on subjects with a complete set of Hb values from central laboratory.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)"||1.10|0.45|0.12
73963458|NCT05165485|147462584|SUPERIORITY||Mean Difference (Net)|-23.0||||0.22|TWO_SIDED|95.0|-61.0|14.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence, stopping after the first failure to reject the null hypothesis.|Mixed Models Analysis|Denominator degrees of freedom were approximated by the Kenward and Roger (1997) method.|Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|14|-61|0.22
73971073|NCT04285515|147482438|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.91|-0.31|||Mixed Effects Model for Repeated Measure|||||-0.31|-0.91|<0.0001
73971074|NCT04285515|147482439|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.89|-0.27|||Mixed Effects Model for Repeated Measure|||||-0.27|-0.89|0.0003
73971075|NCT04285515|147482440|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.82|-0.44|||Mixed Effects Model for Repeated Measure|||||-0.44|-0.82|<0.0001
74085035|NCT00381849|147723686|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on cystone.||||0.64
73905734|NCT05896748|147342180|OTHER||Ratio of geometric least square mean|0.948|||||TWO_SIDED|90.0|0.901|0.998|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||0.998|0.901|
73905735|NCT05896748|147342180|OTHER||Ratio of geometric least square mean|0.935|||||TWO_SIDED|90.0|0.877|0.995|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||0.995|0.877|
73905736|NCT05896748|147342180|OTHER||Ratio of geometric least square mean|0.934|||||TWO_SIDED|90.0|0.872|1.0|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||1.000|0.872|
73905737|NCT05896748|147342180|OTHER||Ratio of geometric least square mean|0.999|||||TWO_SIDED|90.0|0.943|1.059|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Ctau within CAB||1.059|0.943|
73971076|NCT04753697|147482466|SUPERIORITY||Difference in Least Square Mean|-1.91|STANDARD_ERROR_OF_MEAN|0.544||0.0005|TWO_SIDED|95.0|-2.97|-0.84|||ANCOVA|||||-0.84|-2.97|0.0005
73963459|NCT05165485|147462585|SUPERIORITY||Mean Difference (Net)|-9.0|||||TWO_SIDED|95.0|-38.0|20.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The OTE is defined as the average of the Day 30, Day 60, and Day 85 Revefenacin - Tiotropium Least Squares Mean differences. The null hypothesis was that the OTE Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|20|-38|
73963460|NCT05165485|147462586|SUPERIORITY||Mean Difference (Net)|2.0|||||TWO_SIDED|95.0|-29.0|32.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|32|-29|
73963461|NCT05165485|147462587|SUPERIORITY||Mean Difference (Net)|-6.0|||||TWO_SIDED|95.0|-40.0|29.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|29|-40|
73963462|NCT05165485|147462588|SUPERIORITY||Mean Difference (Net)|-41.0|||||TWO_SIDED|95.0|-118.0|35.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference.|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FVC, screening FVC, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|35|-118|
73963463|NCT05165485|147462589|SUPERIORITY||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.39|0.92||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Regression, Logistic||The profile likelihood method was used to estimate the Revefenacin / Tiotropium responder OR.|The null hypothesis was that the Revefenacin / Tiotropium responder Odds Ratio was equal to 1 and the alternative hypothesis was that it was not equal to 1.|The Revefenacin / Tiotropium responder OR was estimated by fitting a logistic regression model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|0.92|0.39|
73971077|NCT04753697|147482467|SUPERIORITY||Difference in percentage|26.4|||<|0.0001|TWO_SIDED|95.0|20.6|32.2|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||32.2|20.6|<0.0001
73971078|NCT04753697|147482468|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI(%)|18.4|||<|0.0001|TWO_SIDED|95.0|11.3|25.5|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||25.5|11.3|<0.0001
73971079|NCT04753697|147482468|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI(%)|17.0|||<|0.0001|TWO_SIDED|95.0|10.1|24.0||Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.|Cochran-Mantel-Haenszel|||||24.0|10.1|<0.0001
73971080|NCT04753697|147482469|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|40.0|||<|0.0001|TWO_SIDED|95.0|33.3|46.7|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status||||46.7|33.3|<0.0001
73971081|NCT04753697|147482470|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|25.7|||<|0.0001|TWO_SIDED|95.0|17.8|33.6|||Cochran-Mantel-Haenszel|Imputed data is used for all in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||33.6|17.8|<0.0001
73971082|NCT04753697|147482470|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|27.7|||<|0.0001|TWO_SIDED|95.0|19.7|35.7|||Cochran-Mantel-Haenszel|Imputed data is used for all in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||35.7|19.7|<0.0001
73971083|NCT04753697|147482471|SUPERIORITY||DIFFERENCE IN LSM|-2.26|STANDARD_ERROR_OF_MEAN|0.655||0.0006|TWO_SIDED|95.0|-3.55|-0.98|||ANCOVA|||||-0.98|-3.55|0.0006
74025437|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.05||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.||||0.96
74025438|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.5||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.||||0.96
74025439|NCT03182738|147604030|SUPERIORITY|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|2.04||||0.64|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.||||0.64
73963464|NCT05165485|147462590|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.69|1.45||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Regression, Cox||The profile likelihood method was used to estimate the Revefenacin / Tiotropium HR.|The null hypothesis was that the Revefenacin / Tiotropium CompEx Event Hazard Ratio was equal to 1 and the alternative hypothesis was that it was not equal to 1.|The Revefenacin / Tiotropium HR was estimated by fitting a Cox proportional hazards model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|1.45|0.69|
73963465|NCT03237481|147462592|SUPERIORITY||Least Squares Mean Difference (LSMD)|-81.43|STANDARD_ERROR_OF_MEAN|22.592|=|0.0004|TWO_SIDED|95.0|-125.83|-37.02|||ANOVA|||||-37.02|-125.83|= 0.0004
73963466|NCT03237481|147462593|SUPERIORITY||Least Squares Mean Difference (LSMD)|-72.49|STANDARD_ERROR_OF_MEAN|18.23|<|0.0001|TWO_SIDED|95.0|-108.32|-36.65|||ANOVA|||||-36.65|-108.32|< 0.0001
73963467|NCT03237481|147462594|SUPERIORITY||||||=|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||= 0.0001
73963468|NCT03237481|147462595|SUPERIORITY||Risk Difference (RD)|0.111|||=|0.0486|TWO_SIDED|95.0|0.003|0.218|||Fisher Exact|||||0.218|0.003|= 0.0486
73963469|NCT03237481|147462596|SUPERIORITY||||||=|0.024|||||||Wilcoxon (Mann-Whitney)|||||||= 0.024
74025440|NCT04112914|147604063|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.021|TWO_SIDED||||||Regression, Linear|||||||0.021
73855724|NCT03268954|147258221|SUPERIORITY||Hazard Ratio (HR)|1.231|||=|0.774|TWO_SIDED|95.0|0.715|2.119||P-value comparing duration of RBC or platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of RBC Transfusion Independence||2.119|0.715|=0.774
73855725|NCT03268954|147258221|SUPERIORITY||Hazard Ratio (HR)|1.533|||=|0.801|TWO_SIDED|95.0|0.567|4.147||P-value comparing duration of platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of Platelet Transfusion Independence||4.147|0.567|=0.801
74025441|NCT04112914|147604064|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.638|TWO_SIDED||||||Regression, Linear|||||||0.638
73963470|NCT01780298|147462597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.278|||<|0.0001|TWO_SIDED|95.0|-42.203|-30.352|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||-30.352|-42.203|<0.0001
73963471|NCT01780298|147462597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.739|||<|0.0001|TWO_SIDED|95.0|-38.418|-27.06|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||-27.060|-38.418|<0.0001
73963472|NCT01780298|147462597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.265|||<|0.0001|TWO_SIDED|95.0|-31.081|-19.449|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||-19.449|-31.081|<0.0001
73963473|NCT01780298|147462597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.538||||0.1504|TWO_SIDED|95.0|-8.398|1.321|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||1.321|-8.398|0.1504
73963474|NCT01780298|147462597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.474||||0.0002|TWO_SIDED|95.0|-11.207|-3.741|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||-3.741|-11.207|0.0002
73855726|NCT03268954|147258221|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.45|TWO_SIDED|95.0|0.58|1.614||P-value comparing duration of RBC or platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of Transfusion Independence||1.614|0.580|=0.450
74085036|NCT00381849|147723686|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.72
74085037|NCT00381849|147723686|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 46 weeks' treatment on cystone.||||0.84
74085038|NCT00381849|147723689|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on placebo.||||0.69
74085039|NCT00381849|147723689|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on cystone.||||0.25
73905738|NCT05896748|147342181|OTHER||Ratio of geometric least square mean|1.002|||||TWO_SIDED|90.0|0.952|1.056|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||1.056|0.952|
73905739|NCT05896748|147342181|OTHER||Ratio of geometric least square mean|0.961|||||TWO_SIDED|90.0|0.921|1.002|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||1.002|0.921|
73905740|NCT05896748|147342181|OTHER||Ratio of geometric least square mean|0.928|||||TWO_SIDED|90.0|0.885|0.973|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||0.973|0.885|
73905741|NCT05896748|147342181|OTHER||Ratio of geometric least square mean|1.003|||||TWO_SIDED|90.0|0.955|1.053|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Ctau within RPV||1.053|0.955|
73905742|NCT05896748|147342182|OTHER||Ratio of geometric least square mean|0.942|||||TWO_SIDED|90.0|0.897|0.99|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.990|0.897|
73905743|NCT05896748|147342182|OTHER||Ratio of geometric least square mean|0.911|||||TWO_SIDED|90.0|0.86|0.965|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.965|0.860|
73905744|NCT05896748|147342182|OTHER||Ratio of geometric least square mean|0.91|||||TWO_SIDED|90.0|0.857|0.966|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.966|0.857|
73905745|NCT05896748|147342182|OTHER||Ratio of geometric least square mean|1.003|||||TWO_SIDED|90.0|0.938|1.074|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Cmax within CAB||1.074|0.938|
73971084|NCT04753697|147482471|SUPERIORITY||DIFFERENCE IN LSM|-2.49|STANDARD_ERROR_OF_MEAN|0.657||0.0002||95.0|-3.78|-1.2|||ANCOVA|||||-1.20|-3.78|0.0002
73971085|NCT04753697|147482472|SUPERIORITY||DIFFERENCE IN LSM|-4.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-4.8|-3.2|||ANCOVA|||||-3.2|-4.8|<0.0001
73971086|NCT04753697|147482473|SUPERIORITY||DIFFERENCE IN LSM|-3.5|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.5|-2.4|||ANCOVA|||||-2.4|-4.5|<0.0001
73971087|NCT04753697|147482473|SUPERIORITY||DIFFERENCE IN LSM|-3.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.1|-2.1|||ANCOVA|||||-2.1|-4.1|<0.0001
73971088|NCT04753697|147482474|SUPERIORITY||DIFFERENCE IN LSM|-22.51|STANDARD_ERROR_OF_MEAN|1.528|<|0.0001|TWO_SIDED|95.0|-25.5|-19.51|||ANCOVA|||||-19.51|-25.50|<0.0001
73971089|NCT04753697|147482475|SUPERIORITY||DIFFERENCE IN LSM|-18.13|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-21.85|-14.4|||ANCOVA|||||-14.40|-21.85|<0.0001
73971090|NCT04753697|147482475|SUPERIORITY||DIFFERENCE IN LSM|-19.22|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-22.9|-15.53|||ANCOVA|||||-15.53|-22.90|<0.0001
73971091|NCT04753697|147482476|SUPERIORITY||DIFFERENCE IN LSM|-25.4|STANDARD_ERROR_OF_MEAN|1.793|<|0.0001|TWO_SIDED|95.0|-28.92|-21.89|||ANCOVA|||||-21.89|-28.92|<0.0001
73971092|NCT04753697|147482477|SUPERIORITY||DIFFERENCE IN LSM|-20.82|STANDARD_ERROR_OF_MEAN|2.229|<|0.0001|TWO_SIDED|95.0|-25.17|-18.91|||Cochran-Mantel-Haenszel|||||-18.91|-25.17|<0.0001
73971093|NCT04753697|147482477|SUPERIORITY||DIFFERENCE IN LSM|-23.43|STANDARD_ERROR_OF_MEAN|2.222|<|0.0001|TWO_SIDED|95.0|-27.73|-21.56|||ANCOVA|||||-21.56|-27.73|<0.0001
73971094|NCT04753697|147482478|SUPERIORITY||DIFFERENCE IN LSM|-4.1|STANDARD_ERROR_OF_MEAN|1.174||0.0005|TWO_SIDED|95.0|-6.4|-1.8|||ANCOVA|||||-1.80|-6.40|0.0005
73971095|NCT04753697|147482479|SUPERIORITY||DIFFERENCE IN LSM|-4.35|STANDARD_ERROR_OF_MEAN|1.42||0.0022|TWO_SIDED|95.0|-7.14|-1.57|||ANCOVA|||||-1.57|-7.14|0.0022
73971096|NCT04753697|147482479|SUPERIORITY||Difference in LSM|-5.2|STANDARD_ERROR_OF_MEAN|1.425||0.0003|TWO_SIDED|95.0|-8.0|-2.41|||ANCOVA|||||-2.41|-8.00|0.0003
73971097|NCT04753697|147482480|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|16.9||||0.0016|TWO_SIDED|95.0|6.7|27.2|||ANCOVA|||||27.2|6.7|0.0016
73971098|NCT01658930|147482499|NON_INFERIORITY|Margin of inferiority in the difference of 3 year pelvic recurrence rates between simple and radical hysterectomy group was 4%.|Mean Difference (Final Values)|0.0035|||||TWO_SIDED|90.0|-0.0162|0.0232|||||Difference between simple and radical hysterectomy groups.|||0.0232|-0.0162|
73971099|NCT01658930|147482500|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.47|2.67|||||Hazard ratio of simple to radical hysterectomy.|||2.67|0.47|
73971100|NCT01658930|147482501|SUPERIORITY||Hazard Ratio (HR)|3.82|||||TWO_SIDED|95.0|0.79|18.4|||||Hazard ratio is simple hysterectomy group of radical hysterectomy group.|||18.4|0.79|
73971101|NCT01658930|147482502|SUPERIORITY||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.69|3.45|||||Hazard ratio is simple hysterectomy group to radical hysterectomy group.|||3.45|0.69|
73971102|NCT01658930|147482503|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.38|3.14|||||Hazard ratio of simple to radical hysterectomy.|||3.14|0.38|
73971103|NCT03701763|147482523|SUPERIORITY||Percentage Adjusted Difference|21.7|||<|0.0001|TWO_SIDED|95.0|11.2|32.1|||Cochran-Mantel-Haenszel|||||32.1|11.2|<0.0001
73971104|NCT03701763|147482524|SUPERIORITY||Percentage Adjusted Difference|29.4|||<|0.0001|TWO_SIDED|95.0|17.8|40.9|||Cochran-Mantel-Haenszel|||||40.9|17.8|<0.0001
73971105|NCT03701763|147482525|SUPERIORITY||Percentage Adjusted Difference|38.4|||<|0.0001|TWO_SIDED|95.0|25.6|51.2|||Cochran-Mantel-Haenszel|||||51.2|25.6|<0.0001
73905746|NCT05896748|147342183|OTHER||Ratio of geometric least square mean|0.938|||||TWO_SIDED|90.0|0.895|0.982|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.982|0.895|
73905747|NCT05896748|147342183|OTHER||Ratio of geometric least square mean|0.918|||||TWO_SIDED|90.0|0.876|0.963|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.963|0.876|
73905748|NCT05896748|147342183|OTHER||Ratio of geometric least square mean|0.905|||||TWO_SIDED|90.0|0.861|0.952|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.952|0.861|
73905749|NCT05896748|147342183|OTHER||Ratio of geometric least square mean|0.937|||||TWO_SIDED|90.0|0.891|0.986|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Cmax within RPV||0.986|0.891|
73905750|NCT05896748|147342184|OTHER||Ratio of geometric least square mean|0.944|||||TWO_SIDED|90.0|0.906|0.983|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.983|0.906|
73905751|NCT05896748|147342184|OTHER||Ratio of geometric least square mean|0.944|||||TWO_SIDED|90.0|0.895|0.995|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.995|0.895|
73905752|NCT05896748|147342184|OTHER||Ratio of geometric least square mean|0.933|||||TWO_SIDED|90.0|0.876|0.994|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.994|0.876|
73905753|NCT05896748|147342184|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.979|1.105|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for AUC\[0-tau\] within CAB||1.105|0.979|
73905754|NCT05896748|147342185|OTHER||Ratio of geometric least square mean|0.966|||||TWO_SIDED|90.0|0.932|1.002|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||1.002|0.932|
73905755|NCT05896748|147342185|OTHER||Ratio of geometric least square mean|0.955|||||TWO_SIDED|90.0|0.922|0.989|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||0.989|0.922|
73905756|NCT05896748|147342185|OTHER||Ratio of geometric least square mean|0.948|||||TWO_SIDED|90.0|0.907|0.991|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||0.991|0.907|
73905757|NCT05896748|147342185|OTHER||Ratio of geometric least square mean|1.014|||||TWO_SIDED|90.0|0.972|1.058|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for AUC\[0-tau\] within RPV||1.058|0.972|
73905758|NCT02325791|147342236|SUPERIORITY||percentage treatment difference|1.15||||0.5773|TWO_SIDED|95.0|-2.898|5.201|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||5.201|-2.898|0.5773
73905759|NCT02325791|147342236|SUPERIORITY||percentage treatment difference|-0.44|||||TWO_SIDED|95.0|-4.318|3.438||Analysis performed using CMH statistics with randomization stratum adjusted using Mantel-Haenzel (MH) method to assess pairwise treatment difference (i.e. absolute risk reduction of each suptavumab arm compared to placebo.|Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each Suptavumab dose regimen to placebo. Missing values were imputed to Kaplan-Meier (KM) estimate from the placebo group. Randomization strata adjusted in Cochran-Mantel-Haenszel (CMH) test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||3.438|-4.318|
73905760|NCT02325791|147342240|SUPERIORITY||percentage treatment difference|-0.67|||||TWO_SIDED|95.0|-5.291|3.959|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||3.959|-5.291|
73905761|NCT02325791|147342240|SUPERIORITY||percentage treatment difference|2.02|||||TWO_SIDED|95.0|-2.836|6.867|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||6.867|-2.836|
73905762|NCT01231230|147342284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|||<|0.001|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||< 0.001
73905763|NCT01231230|147342284|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||<0.001
73905764|NCT01231230|147342284|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||>0.05
73905765|NCT00252629|147342297|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||The change of fatigue complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.0002
73905766|NCT00252629|147342298|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||t-test, 2 sided|||The change of pain symptom from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.0008
73905767|NCT00252629|147342299|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||The change of cognitive dysfunction complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.004
73905768|NCT00252629|147342300|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||t-test, 2 sided|||The p value was based on t-test||||0.0001
73971106|NCT03701763|147482526|SUPERIORITY||Difference in Least Squares Mean|-26.97|STANDARD_ERROR_OF_MEAN|4.572|<|0.0001|TWO_SIDED|95.0|-35.93|-18.0|||ANCOVA|||||-18.00|-35.93|<0.0001
73971107|NCT03701763|147482527|SUPERIORITY||Difference in Least Squares Mean|-34.77|STANDARD_ERROR_OF_MEAN|6.229|<|0.0001|TWO_SIDED|95.0|-46.99|-22.55|||ANCOVA|||||-22.55|-46.99|< 0.0001
73905769|NCT01505647|147342307|NON_INFERIORITY_OR_EQUIVALENCE|The GMT induced by ZOSTAVAX™ (AMP) vaccine is statistically non-inferior to that induced by the current process vaccine if the lower bound of the 95% confidence interval of the GMT ratio is \>0.67.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.98|1.2||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||The hypothesis tested is that the GMT at Week 6 postvaccination with ZOSTAVAX™ (AMP) vaccine is non-inferior to that with the current process vaccine||1.20|0.98|<0.001
73905770|NCT01505647|147342308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|t-test, 1 sided|||The hypothesis tested was that ZOSTAVAX™ (AMP) induces an acceptable GMFR in VZV antibody titer from prevaccination to 6 weeks postvaccination||||<0.001
73905771|NCT02750943|147342312|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-25.34|||<|0.0001|TWO_SIDED|95.0|-30.682|-19.998||From ANCOVA analysis with treatment group, gender and baseline MGI stratification as factors baseline as covariates.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-19.998|-30.682|<0.0001
73905772|NCT03635788|147342341|SUPERIORITY|The study had approximately 80% power to show superiority of the LA ART compared to daily SOC with respect to the Step 2, week 48, cumulative probability of regimen failure|Cumulative probability difference|-18.4|||||TWO_SIDED|98.4|-32.4|-4.3|||||Treatment difference was calculated as LA-ART minus SOC. 98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of regimen failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||-4.3|-32.4|
73905773|NCT03635788|147342342|SUPERIORITY|The study had at least 80% power to show superiority of the LA ART compared to daily SOC with respect to the Step 2, week 48, cumulative probability of virologic failure|cumulative probability difference|-21.4|||||TWO_SIDED|98.4|-33.5|-9.3|||||Treatment difference was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of virologic failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||-9.3|-33.5|
73905774|NCT03635788|147342343|SUPERIORITY||cumulative probability diffeence|-19.2|||||TWO_SIDED|98.4|-31.6|-6.9||||||Treatment comparison was conducted by cumulative probability of treatment-related failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.|Treatment difference was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|-6.9|-31.6|
73905775|NCT03635788|147342344|SUPERIORITY|The proportions of participants with HIV-1 RNA ≥ 50 copies/ml was compared by Fisher's Exact Test.|Mean Difference (Final Values)|-21.8|||<|0.001|TWO_SIDED|95.0|-35.6|-8.1|||Fisher Exact||||Treatment difference in the proportions of participants with HIV-1 RNA ≥ 50 copies/ml was calculated as LA-ART minus SOC.|-8.1|-35.6|<0.001
73905776|NCT03635788|147342345|SUPERIORITY||Mean Difference (Final Values)|-24.5|||<|0.001|TWO_SIDED|95.0|-36.1|-12.8|||Fisher Exact||Difference in the proportions of participants with HIV-1 RNA ≥ 200 copies was calculated as LA-ART minus SOC.|The proportions of participants with HIV-1 RNA ≥ 200 copies/ml was compared by Fisher's Exact Test.||-12.8|-36.1|<0.001
73905777|NCT03635788|147342350|SUPERIORITY||Cumulative probability difference|-8.4|||||TWO_SIDED|98.4|-21.3|4.5|||||Treatment difference in cumulative of permanent treatment discontinuation was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of permanent treatment discontinuation in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||4.5|-21.3|
73905778|NCT03811002|147342397|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.5819|TWO_SIDED|95.0|0.82|1.34|||Log Rank|Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). 1-sided significance level 0.025.|Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|Assuming exponentially distributed survival times, 480 eligible patients accrued uniformly over 48 months months) with 26 months additional follow-up after the last accrued patient would provide at least 85% power to detect a hazard ratio of 0.71 (median survival times of 38 months \[Arm I\] vs. 27 months \[Arm II\]) at a one-sided significance level of 0.025, after adjusting for type 1 error using group sequential methods for two interim analyses.||1.34|0.82|0.5819
73905779|NCT03811002|147342398|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||Log Rank||Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|||1.21|0.80|
73905780|NCT03811002|147342401|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.52|1.41|||||Cause-specific hazard ratio stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|||1.41|0.52|
73905781|NCT03811002|147342402|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||||Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm I.|||1.20|0.76|
73905782|NCT04191187|147342412|SUPERIORITY||PFS at 18 Months|70.8||||0.002|ONE_SIDED|90.0|59.2|||One sided log rank test|Log Rank||||||59.2|0.002
73905783|NCT03552965|147342418|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=1.14, SD=0.378, Range=1, 25th percentile=1, Median=1, 75th percentile=1, n=7 Robust: Mean=1.17, SD=0.577, Range=2, 25th percentile=1, Median=1, 75th percentile=1, n=12"|||
73963475|NCT01780298|147462597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.013|||<|0.0001|TWO_SIDED|95.0|-15.979|-6.046|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||-6.046|-15.979|<0.0001
73971108|NCT03701763|147482528|SUPERIORITY||Percentage Adjusted Difference|4.1||||0.5616|TWO_SIDED|95.0|-9.8|18.0|||Cochran-Mantel-Haenszel|||||18.0|-9.8|0.5616
74025442|NCT04112914|147604065|SUPERIORITY||Odds Ratio (OR)|1.77||||0.338|TWO_SIDED|95.0|0.55|5.72|||Regression, Logistic|||||5.72|0.55|0.338
73905784|NCT03552965|147342419|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2, SD=0.894, Range=2, 25th percentile=1, Median=2, 75th percentile=3, n=6 Robust: Mean=2.91, SD=1.136, Range=3, 25th percentile=2, Median=3, 75th percentile=4, n=11"|||
73905785|NCT03552965|147342420|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2.5, SD=0.577, Range=1, 25th percentile=2, Median=2.5, 75th percentile=3, n=4 Robust: Mean=2.33, SD=1.225, Range=3, 25th percentile=1, Median=2, 75th percentile=3.5, n=9"|||
73905786|NCT03552965|147342421|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=1.83, SD=0.753, Range=2, 25th percentile=1, Median=2, 75th percentile=2.25, n=6 Robust: Mean=2.33, SD=1, Range=3, 25th percentile=1.5, Median=2, 75th percentile=3, n=9"|||
73905787|NCT03552965|147342422|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2, SD=0.707, Range=2, 25th percentile=1.5, Median=2, 75th percentile=2.5, n=5 Robust: Mean=2.38, SD=1.188, Range=3, 25th percentile=1.25, Median=2, 75th percentile=3.75, n=8"|||
73905788|NCT03552965|147342423|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=15.5, SD=23.76242, Range=75, 25th percentile=0, Median=5, 75th percentile=21.25, n=10 Robust: Mean=14.1346, SD=17.87095, Range=52.5, 25th percentile=0, Median=6.25, 75th percentile=27.5, n=13"|||
73905789|NCT03552965|147342424|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=45.625, SD=30.68744, Range=71.25, 25th percentile=11.25, Median=58.125, 75th percentile=71.25, n=6 Robust: Mean=64.3182, SD=15.0142, Range=48.75, 25th percentile=66.25, Median=70, 75th percentile=71.25, n=11"|||
73905790|NCT03552965|147342425|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=60, SD=23.68412, Range=60, 25th percentile=38.125, Median=68.75, 75th percentile=77.5, n=5 Robust: Mean=54.8611, SD=29.91815, Range=80, 25th percentile=24.375, Median=66.25, 75th percentile=80, n=9"|||
73905791|NCT03552965|147342426|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=31.67, SD=31.38139, Range=85, 25th percentile=5.625, Median=25, 75th percentile=56.875, n=6 Robust: Mean=54.0278, SD=24.57274, Range=67.5, 25th percentile=33.75, Median=62.5, 75th percentile=72.5, n=9"|||
73905792|NCT03552965|147342427|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=50.75, SD=30.29284, Range=72.5, 25th percentile=21.875, Median=48.75, 75th percentile=80.625, n=5 Robust: Mean=38.4375, SD=26.69897, Range=66.25, 25th percentile=15, Median=29.375, 75th percentile=68.75, n=8"|||
73905793|NCT02477696|147342435|NON_INFERIORITY|Non-inferiority of acalabrutinib was demonstrated if the upper bound of the 2-sided 95% confidence interval (CI) of the hazard ratio was below 1.429.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.79|1.27|||||Cox Proportional Hazards model stratified by 17p deletion status (yes versus no) and number of prior therapies (1-3 versus \>=4).|||1.27|0.79|
73905794|NCT02160782|147342447|EQUIVALENCE|The P-value for testing if the treatment group least squares (LS) means were equal was calculated to determine if the change in sBA levels between the treatment groups was statistically significant.|Mean Difference (Net)|-117.28|STANDARD_ERROR_OF_MEAN|52.828||0.0464|TWO_SIDED|95.0|-232.38|-2.18|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in fasting sBA levels was evaluated using an analysis of covariance (ANCOVA) model with treatment group as a factor, and Week 18 sBA as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the MITT population, which included all participants who were enrolled, received study drug through Week 18, and had a reduction from baseline in sBA of ≥50% at the Week 12 or Week 18 measurement.||-2.18|-232.38|0.0464
73905795|NCT02160782|147342448|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-87.73|STANDARD_DEVIATION|119.979||0.0005|TWO_SIDED|95.0|-133.37|-42.09||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||-42.09|-133.37|0.0005
73905796|NCT02160782|147342449|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Obs) scores between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-1.704|STANDARD_DEVIATION|0.9114|<|0.0001|TWO_SIDED|95.0|-2.051|-1.357|||Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) score was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity.||-1.357|-2.051|< 0.0001
73971109|NCT03701763|147482529|SUPERIORITY||Difference in Least Squares Mean|-1.8||||0.0009|TWO_SIDED|95.0|-2.9|-0.8|||ANCOVA|||||-0.8|-2.9|0.0009
73971110|NCT03511664|147482566|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.001|TWO_SIDED|99.2|0.29|0.57|||Log Rank|one-sided stratified log-rank test||||0.57|0.29|< 0.001
73971111|NCT03511664|147482567|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.52|0.74|||Log Rank|one-sided stratified log-rank test||Primary OS Analysis||0.74|0.52|<0.001
73971112|NCT03511664|147482567|SUPERIORITY||Cox Proportional Hazard|0.68|||||TWO_SIDED|95.0|0.58|0.81|||||Cox PH model stratified by LDH (≤260 vs. \>260 IU/L), liver metastases (yes/no), ECOG score (0-1 vs. 2), and NAAD inclusion in best supportive care at randomization (yes/no). IRT data used for stratification|Final OS analysis||0.81|0.58|
73971113|NCT03511664|147482569|SUPERIORITY||Odds Ratio (OR)|24.99|||<|0.001|TWO_SIDED|95.0|6.05|103.24|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||103.24|6.05|< 0.001
73971114|NCT03511664|147482570|SUPERIORITY||Odds Ratio (OR)|5.79|||<|0.001|TWO_SIDED|95.0|3.18|10.55|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||10.55|3.18|< 0.001
73971115|NCT03511664|147482572|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.62|||Log Rank|Two-sided stratified log-rank test||||0.62|0.40|< 0.001
73971116|NCT03511664|147482573|SUPERIORITY||Cox Proportional Hazard|0.3|||<|0.001|TWO_SIDED|95.0|0.24|0.38|||Log Rank|Two-sided stratified log-rank test||||0.38|0.24|< 0.001
74025443|NCT04112914|147604066|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.606|TWO_SIDED||||||Regression, Linear|||||||0.606
74025444|NCT04112914|147604067|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.508|TWO_SIDED||||||Regression, Linear|||||||0.508
74025445|NCT04112914|147604068|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.042|TWO_SIDED||||||Regression, Linear|||||||0.042
74025446|NCT04112914|147604069|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.128|TWO_SIDED||||||Regression, Linear|||||||0.128
74025447|NCT01873950|147604134|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
74025448|NCT01873950|147604135|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
74085040|NCT00381849|147723689|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.15
74085041|NCT00381849|147723689|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 46 weeks' treatment on cystone.||||0.20
74085042|NCT00381849|147723690|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline||||0.85
74085043|NCT00381849|147723690|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline||||0.63
74085044|NCT00381849|147723690|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline||||0.97
74085045|NCT00381849|147723690|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline||||0.15
74085046|NCT00381849|147723691|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline||||0.81
74085047|NCT00381849|147723691|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline||||0.78
73905797|NCT02160782|147342450|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Pt) scores between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-2.072|STANDARD_DEVIATION|0.9931|<|0.0001|TWO_SIDED|95.0|-2.645|-1.498|||Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Pt) score was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity.||-1.498|-2.645|< 0.0001
73905798|NCT02160782|147342451|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ItchRO(Obs) between the treatment groups was statistically significant.|Mean Difference (Net)|-1.483|STANDARD_ERROR_OF_MEAN|0.3103|<|0.0001|TWO_SIDED|95.0|-2.122|-0.844|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ItchRO(Obs) was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ItchRO(Obs) as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||-0.844|-2.122|< 0.0001
73905799|NCT02160782|147342452|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ItchRO(Pt) between the treatment groups was statistically significant. While the number of participants included in analysis for the end point indicates 28, there were only 14; n = 5 for ItchRO(Pt): MRX and n = 9 for ItchRO(Pt): placebo.|Mean Difference (Net)|-1.988|STANDARD_ERROR_OF_MEAN|0.4641||0.0013|TWO_SIDED|95.0|-3.009|-0.967|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ItchRO (Pt) was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ItchRO(Pt) as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||-0.967|-3.009|0.0013
73905800|NCT02160782|147342453|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-27.8|STANDARD_DEVIATION|118.33||0.2163|TWO_SIDED|95.0|-72.8|17.2||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||17.2|-72.8|0.2163
73905801|NCT02160782|147342454|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ALP levels between the treatment groups was statistically significant.|Mean Difference (Net)|10.0|STANDARD_ERROR_OF_MEAN|30.44||0.7455|TWO_SIDED|95.0|-52.6|72.6|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ALP levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALP as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||72.6|-52.6|0.7455
73905802|NCT02160782|147342455|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-1.3|STANDARD_DEVIATION|84.54||0.9358|TWO_SIDED|95.0|-33.4|30.9||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||30.9|-33.4|0.9358
74085048|NCT00381849|147723691|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline||||0.96
73905803|NCT02160782|147342456|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ALT levels between the treatment groups was statistically significant.|Mean Difference (Net)|15.1|STANDARD_ERROR_OF_MEAN|19.53||0.4472|TWO_SIDED|95.0|-25.1|55.2|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ALT levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALT as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||55.2|-25.1|0.4472
73905804|NCT02160782|147342457|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-0.47|STANDARD_DEVIATION|1.424||0.0893|TWO_SIDED|95.0|-1.01|0.08|||Student's t-test|||||0.08|-1.01|0.0893
73905805|NCT02160782|147342458|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in total bilirubin between the treatment groups was statistically significant.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.361||0.7|TWO_SIDED|95.0|-0.88|0.6|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in total bilirubin was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 total bilirubin as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||0.6|-0.88|0.7
73905806|NCT02160782|147342459|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.012||0.0139|TWO_SIDED|95.0|-0.9|-0.11|||Student's t-test|||||-0.11|-0.9|0.0139
73905807|NCT02160782|147342460|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in direct bilirubin between the treatment groups was statistically significant.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.265||0.9517|TWO_SIDED|95.0|-0.56|0.53|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in direct bilirubin levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 direct bilirubin as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||0.53|-0.56|0.9517
73905808|NCT03437512|147342475|SUPERIORITY||||||<|0.001||||||familywise error rate (FWE) corrected to .05 with cluster threshold of 80 voxels.|t-test, 2 sided|||||||<.001
73905809|NCT03437512|147342476|SUPERIORITY|||||||0.936||||||Interaction between visit and group.|ANOVA|||Analyses conduced with a mixed ANOVA, with between-subjects factor of group (active, sham) and two within-subjects factors: time (post, follow up) and speech task (reading, conversation).||||.936
73905810|NCT03437512|147342477|SUPERIORITY|||||||0.619||||||Interaction between visit and group.|ANOVA|||||||.619
73963476|NCT01780298|147462598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.611|||<|0.0001|TWO_SIDED|95.0|-32.249|-22.973|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||-22.973|-32.249|<0.0001
73963477|NCT01780298|147462598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.553|||<|0.0001|TWO_SIDED|95.0|-29.501|-19.604|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||-19.604|-29.501|<0.0001
74085049|NCT00381849|147723691|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline||||0.13
74085050|NCT00745134|147723697|OTHER|||||||0.33|||||||ANOVA|||||||0.33
73905811|NCT00674973|147342481|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1909|TWO_SIDED|95.0|0.63|1.1|||Log Rank|||Cox proportional hazards model was used to estimate the Hazard Ratio (erlotinib compared with placebo), including 95 percent (%) confidence intervals (CIs).||1.10|0.63|0.1909
73905812|NCT00763048|147342486|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
73905813|NCT00763048|147342487|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
73905814|NCT00763048|147342488|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
73905815|NCT00763048|147342489|SUPERIORITY_OR_OTHER|||||||0.05|ONE_SIDED|95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
73905816|NCT00763048|147342490|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
73905817|NCT00763048|147342491|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
73905818|NCT00763048|147342492|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
73905819|NCT00763048|147342493|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
73905820|NCT00763048|147342494|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
73963478|NCT01780298|147462598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.107|||<|0.0001|TWO_SIDED|95.0|-19.043|-9.17|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||-9.170|-19.043|<0.0001
73963479|NCT01780298|147462598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.058||||0.0983|TWO_SIDED|95.0|-6.702|0.585|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.585|-6.702|0.0983
73963480|NCT01780298|147462598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.446|||<|0.0001|TWO_SIDED|95.0|-13.845|-7.047|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||-7.047|-13.845|<0.0001
74085051|NCT00996437|147723722|SUPERIORITY_OR_OTHER||Treatment Difference in Cumulative Prob|4.0||||0.37|TWO_SIDED|95.0|-4.0|13.0|||Log Rank|After adjusting for potential confounding factors, time to vitrectomy remained similar between treatment groups.||The cumulative probabilities of vitrectomy by 16 weeks in each group were computed using the life-table method. Treatment group comparisons were performed using the log-rank test. The treatment difference in cumulative probabilities and 95% confidence interval were reported.||13|-4|0.37
74085052|NCT00996437|147723723|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value corresponds with recurrent vitreous hemorrhage evaluated on clinical exam between the two treatment arms.|Fisher Exact|||||||0.01
74085053|NCT00996437|147723724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54||||0.05|TWO_SIDED|95.0|1.03|2.3|||Log Rank|||||2.30|1.03|0.05
73855727|NCT03268954|147258222|SUPERIORITY||Hazard Ratio (HR)|0.88|||=|0.228|TWO_SIDED|95.0|0.628|1.234||P-value comparing time to first CR or PR or CRi (low-blast AML) between treatment groups was based on 1-sided stratified log-rank test stratified by low-blast AML,IPSS-R risk groups of very high,high,or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission with Incomplete Blood Count Recovery (CRi)||1.234|0.628|=0.228
73855728|NCT03268954|147258223|SUPERIORITY||Absolute Rate Difference|-5.46|||=|0.32|TWO_SIDED|95.0|-16.36|5.44||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Number of Participants With HI||5.44|-16.36|=0.320
73855729|NCT03268954|147258224|SUPERIORITY||Rate Difference|2.64|||||TWO_SIDED|95.0|-0.3|5.58||||||Number of Participants With at Least 1 Inpatient Hospital Admissions Related to HR MDS, CMML or Low-blast AML||5.58|-0.30|
73855730|NCT03268954|147258225|SUPERIORITY||Hazard Ratio (HR)|0.858|||=|0.084|TWO_SIDED|95.0|0.689|1.067||P-value was obtained from a stratified 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on a stratified Cox proportional hazard regression model stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML, with treatment as a factor in the model.|Time to Progressive Disease (PD), Relapse after CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death||1.067|0.689|=0.084
73855731|NCT03268954|147258226|SUPERIORITY||Hazard Ratio (HR)|0.75|||=|0.002|TWO_SIDED|95.0|0.615|0.913|||Log Rank|||||0.913|0.615|=0.002
73855732|NCT03268954|147258228|SUPERIORITY||Absolute Rate Difference|-2.85|||=|0.683|TWO_SIDED|95.0|-19.44|13.75||P-value for HR MDS/CMML was obtained from a stratified Cochran-Mantel-Haenszel chi-square test|Cochran-Mantel-Haenszel|||OR: HR MDS/CMML Participants||13.75|-19.44|=0.683
73855733|NCT03268954|147258228|SUPERIORITY||Absolute Rate Difference|2.36|||=|0.84|TWO_SIDED|95.0|-20.39|25.12||P-value for Low-blast AML was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||ORR: Low-blast AML Participants||25.12|-20.39|=0.840
73855734|NCT03268954|147258229|SUPERIORITY||Hazard Ratio (HR)|0.877|||=|0.24|TWO_SIDED|95.0|0.608|1.263||P-value comparing EFS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification factors (IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|Event-Free Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group||1.263|0.608|=0.240
73855735|NCT03268954|147258230|SUPERIORITY||Hazard Ratio (HR)|0.826|||=|0.145|TWO_SIDED|95.0|0.58|1.178||P-value comparing OS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification factors(IPSS-R risk groups of very high,high,intermediate) and treatment as factor in model.HR\<1: longer survival time in combination arm than azacitidine arm.|Overall Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group||1.178|0.580|=0.145
73855736|NCT03268954|147258231|SUPERIORITY||Absolute Rate Difference|-5.14|||=|0.261|TWO_SIDED|95.0|-13.95|3.68||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Overall Response for HR MDS/CMML||3.68|-13.95|=0.261
73855737|NCT03268954|147258231|SUPERIORITY||Absolute Rate Difference|22.36|||=|0.026|TWO_SIDED|95.0|3.22|41.49||P-value was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Overall Response for Low-blast AML||41.49|3.22|=0.026
73855738|NCT00778258|147258255|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.77||||0.58|TWO_SIDED|95.0|0.31|1.93|||Regression, Logistic|||||1.93|0.31|0.58
73855739|NCT00778258|147258256|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.13||||0.78|TWO_SIDED|95.0|0.48|2.68|||Chi-squared|||Progression comparison at 12 Months||2.68|0.48|0.78
73855740|NCT00778258|147258256|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.81||||0.62|TWO_SIDED|95.0|0.34|1.91|||Chi-squared|||Progression comparison at 24 Months||1.91|0.34|0.62
73855741|NCT00778258|147258257|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||Comparison at 12 Months||||0.14
73855742|NCT00778258|147258257|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Chi-squared|||Comparison at 24 Months||||0.17
73855743|NCT00778258|147258257|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Chi-squared|||Comparison at 36 Months||||0.33
73855744|NCT00778258|147258258|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Chi-squared|||||||0.41
73971117|NCT03511664|147482575|SUPERIORITY||Odds Ratio (OR)|11.19|||<|0.001|TWO_SIDED|95.0|6.3|20.0|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||20.0|6.3|< 0.001
73963481|NCT01780298|147462598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.504|||<|0.0001|TWO_SIDED|95.0|-17.302|-9.707|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||-9.707|-17.302|<0.0001
73963482|NCT01780298|147462599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.448|||<|0.0001|TWO_SIDED|95.0|28.374|52.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||52.521|28.374|<0.0001
73905821|NCT01298531|147342538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.27||||0.0019|TWO_SIDED|95.0|-44.17|-10.38|||ANCOVA|Not specifed.||The primary analysis of the primary endpoint was an Analysis of covariance (ANCOVA)with Baseline NSAID score and treatment as explanatory variables. The hypothesis tested for the primary endpoint was as follows: H0: ΔETN = ΔPlacebo; H1: ΔETN ≠ ΔPlacebo.||-10.38|-44.17|0.0019
73905822|NCT01298531|147342539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.78||||0.0115|TWO_SIDED|95.0|-34.99|-4.57|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model and using the repeated measures for the changes from Baseline in each outcome at Week 8.||-4.57|-34.99|0.0115
73905823|NCT01298531|147342540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.0153|TWO_SIDED|95.0|-1.68|-0.18|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 4.||-0.18|-1.68|0.0153
73905824|NCT01298531|147342541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.051|TWO_SIDED|95.0|-1.76|0.0|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 8.||0.00|-1.76|0.0510
73905825|NCT01298531|147342543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.209||||0.0066|TWO_SIDED|95.0|0.07|0.65|||Regression, Logistic|||Logistic regression with baseline score and treatment group included as covariates.||0.65|0.07|0.0066
73905826|NCT01298531|147342544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.7||||0.0053|TWO_SIDED|95.0|-91.01|-16.38|||ANCOVA|||The changes from baseline in the continuous endpoints of mini BASDAI was analyzed using ANCOVA. The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule.||-16.38|-91.01|0.0053
73905827|NCT01298531|147342545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.963||||0.0324|TWO_SIDED|95.0|1.1|8.01|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates.||8.01|1.10|0.0324
74085054|NCT00996437|147723725|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||P-value corresponds to the 12 week visit treatment comparison.|GLM with GEE method|Number of subjects with baseline OCT ss=0 and OCT ss\>0 and no vitrectomy at follow up. A generalized GLM with GEE was used for treatment comparisons.||Signal strength was analyzed as a composite outcome defined as OCT signal strength \> = and no vitrectomy vs. OCT signal strength = 0.||||0.87
73905828|NCT01298531|147342548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.696||||0.0501|TWO_SIDED|95.0|1.0|7.27|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||7.27|1.00|0.0501
73905829|NCT01298531|147342550|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.103||||0.0284|TWO_SIDED|95.0|1.13|8.54|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||8.54|1.13|0.0284
73905830|NCT01298531|147342552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.3291|TWO_SIDED|95.0|0.47|9.72|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||9.72|0.47|0.3291
73905831|NCT01298531|147342553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.44|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.||-0.44|-1.11|<0.0001
73905832|NCT01298531|147342554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0011|TWO_SIDED|95.0|-1.09|-0.28|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.||-0.28|-1.09|0.0011
73963483|NCT01780298|147462599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.538|||<|0.0001|TWO_SIDED|95.0|14.89|38.185|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||38.185|14.890|<0.0001
73971118|NCT03511664|147482576|SUPERIORITY||Odds Ratio (OR)|23.6|||<|0.001|TWO_SIDED|95.0|8.6|65.1|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||65.1|8.6|< 0.001
73971119|NCT06473662|147482597|OTHER||Mean Difference (Final Values)|-0.53||||0.0039|TWO_SIDED||||||t-test, 2 sided|||||||0.0039
73971120|NCT06473662|147482598|OTHER||Mean Difference (Final Values)|-18.8||||0.0166|TWO_SIDED||||||t-test, 2 sided|||||||0.0166
73971121|NCT06473662|147482600|OTHER||Mean Difference (Final Values)|-22.13||||0.0474|TWO_SIDED||||||ANCOVA|||||||0.0474
73971122|NCT03221426|147482724|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.01501|TWO_SIDED|95.0|0.67|0.98||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||0.98|0.67|0.01501
73971123|NCT03221426|147482725|SUPERIORITY||Difference in Percentage|11.4|||<|1e-05|TWO_SIDED|95.0|8.0|15.3|||Stratified Miettinen and Nurminen|Based on Miettinen \& Nurminen method stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)||||15.3|8.0|<0.00001
73971124|NCT03221426|147482726|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07503|TWO_SIDED|95.0|0.71|1.06||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||1.06|0.71|0.07503
73905833|NCT01298531|147342556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0011|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.||-0.24|-0.90|0.0011
73905834|NCT01298531|147342557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0037|TWO_SIDED|95.0|-1.11|-0.22|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.||-0.22|-1.11|0.0037
73905835|NCT01298531|147342561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.005|TWO_SIDED|95.0|-2.2|-0.4|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.||-0.40|-2.20|0.0050
73905836|NCT01298531|147342562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0256|TWO_SIDED|95.0|-2.33|-0.16|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.||-0.16|-2.33|0.0256
73905837|NCT01298531|147342564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.0474|TWO_SIDED|95.0|-2.0|-0.01|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor.||-0.01|-2.00|0.0474
74025449|NCT01873950|147604136|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
74025450|NCT02580058|147604145|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.8253|TWO_SIDED|95.0|0.867|1.497|||Log Rank|1-sided||||1.497|0.867|0.8253
74025451|NCT02580058|147604145|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.2082|TWO_SIDED|95.0|0.672|1.179|||Log Rank|1-sided||||1.179|0.672|0.2082
74025452|NCT02580058|147604146|SUPERIORITY||Hazard Ratio (HR)|1.68|||>|0.9999|TWO_SIDED|95.0|1.31|2.16|||Log Rank|1-sided||||2.160|1.310|>0.9999
74085055|NCT00996437|147723726|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value corresponds to the 12 week visit treatment comparison.|Mixed Models Analysis|Treatment comparisons were performed using a longitudinal mixed model adjusting for baseline visual acuity.||||||.04
73905838|NCT01298531|147342565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0212|TWO_SIDED|95.0|-2.36|-0.2|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor||-0.20|-2.36|0.0212
74025453|NCT02580058|147604146|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0301|TWO_SIDED|95.0|0.607|1.011|||Log Rank|1-sided||||1.011|0.607|0.0301
74025454|NCT02580058|147604165|OTHER||Geometric Mean Ratio (Test/Reference, %)|110.0|||||TWO_SIDED|90.0|95.4|126.7||||||Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment||126.7|95.4|
74025455|NCT02580058|147604166|OTHER||Geometric Mean Ratio (Test/Reference, %)|90.0|||||TWO_SIDED|90.0|79.5|101.5||||||Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment||101.5|79.5|
74025456|NCT02580058|147604167|OTHER||Geometric Mean Ratio (Test/Reference, %)|96.0|||||TWO_SIDED|90.0|87.0|106.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||106|87|
74085056|NCT00996437|147723728|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value corresponds with the 12 week visit treatment comparison|Fisher Exact|At the each time point, treatment comparison analysis was performed using a Fisher Exact test.||||||.023
74085057|NCT00996437|147723729|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Fisher Exact|At each time point, treatment comparison analysis was performed using a Fisher Exact Test.||||||0.27
74085058|NCT04443569|147723730|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Post-Op Day 1||||0.3
74025457|NCT02580058|147604168|OTHER||Geometric Mean Ratio (Test/Reference, %)|95.0|||||TWO_SIDED|90.0|88.0|104.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||104|88|
74025458|NCT02580058|147604169|OTHER||Geometric Mean Ratio (Test/Reference, %)|90.0|||||TWO_SIDED|90.0|76.0|107.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||107|76|
74025459|NCT02580058|147604170|OTHER||Geometric Mean Ratio (Test/Reference, %)|100.0|||||TWO_SIDED|90.0|60.0|168.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||168|60|
74025460|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|-2.0|||||TWO_SIDED|95.0|-7.65|2.88||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||2.88|-7.65|
74025461|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|-14.9|||||TWO_SIDED|95.0|-26.4|-3.21||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-3.21|-26.40|
74085059|NCT04443569|147723730|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Post-Op Day 2||||0.9
73905839|NCT01298531|147342567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0198|TWO_SIDED|95.0|-2.4|-0.21|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor||-0.21|-2.40|0.0198
74025462|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|0.06|||||TWO_SIDED|95.0|-5.84|6.05||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||6.05|-5.84|
74025463|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|2.06|||||TWO_SIDED|95.0|-1.71|7.25||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||7.25|-1.71|
74025464|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|2.12|||||TWO_SIDED|95.0|-4.09|8.89||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||8.89|-4.09|
74025465|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
73905840|NCT01298531|147342568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.0132|TWO_SIDED|95.0|-2.69|-0.32|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor||-0.32|-2.69|0.0132
73905841|NCT01298531|147342570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0237|TWO_SIDED|95.0|-1.5|-0.11|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.||-0.11|-1.50|0.0237
73905842|NCT01298531|147342571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.0297|TWO_SIDED|95.0|-1.74|-0.09|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.||-0.09|-1.74|0.0297
73905843|NCT01298531|147342572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.0152|TWO_SIDED|95.0|-2.09|-0.23|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.||-0.23|-2.09|0.0152
73905844|NCT01298531|147342573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.0344|TWO_SIDED|95.0|-2.22|-0.09|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.||-0.09|-2.22|0.0344
73905845|NCT01298531|147342575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0017|TWO_SIDED|95.0|-2.16|-0.52|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor||-0.52|-2.16|0.0017
73905846|NCT01298531|147342576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.0233|TWO_SIDED|95.0|-2.07|-0.16|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor.||-0.16|-2.07|0.0233
73905847|NCT01298531|147342585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.126|TWO_SIDED|95.0|0.822|4.901|||Regression, Logistic|||Week 8 was analyzed using logistic regression with baseline score and treatment group included as covariates.||4.901|0.822|0.1260
73905848|NCT01298531|147342588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.0498|TWO_SIDED|95.0|1.0|6.08|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates. Week 8 was analyzed using a logistic regression to assess treatment effect.||6.08|1.00|0.0498
73905849|NCT01298531|147342590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.1601|TWO_SIDED|95.0|-0.87|0.15|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor||0.15|-0.87|0.1601
73905850|NCT01298531|147342591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.2967|TWO_SIDED|95.0|-0.86|0.27|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor||0.27|-0.86|0.2967
73905851|NCT01298531|147342597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41||||0.2735|TWO_SIDED|95.0|-1.94|6.75|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.||6.75|-1.94|0.2735
73905852|NCT01298531|147342598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.0422|TWO_SIDED|95.0|0.02|1.34|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.||1.34|0.02|0.0422
73905853|NCT02360995|147342600|SUPERIORITY_OR_OTHER|||||||0.652|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.652
73905854|NCT02360995|147342601|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
73905855|NCT02360995|147342602|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
73905856|NCT02360995|147342603|SUPERIORITY_OR_OTHER|||||||0.533|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.533
73905857|NCT02360995|147342604|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
74025466|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|-6.92|||||TWO_SIDED|95.0|-16.19|1.89||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||1.89|-16.19|
74025467|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|-1.94|||||TWO_SIDED|95.0|-9.07|4.86||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.86|-9.07|
73905858|NCT02360995|147342605|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
73905859|NCT02611960|147342606|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.2262|TWO_SIDED|95.0|0.67|1.19||One-sided p-value based on log-rank test stratified by presence of liver metastasis.|Stratified Log-Rank Test|||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis.||1.19|0.67|0.2262
73905860|NCT02611960|147342607|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.9419|TWO_SIDED|95.0|0.94|1.75||One-sided p-value based on log-rank test stratified by presence of liver metastasis.|Stratified Log-Rank Test|||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis.||1.75|0.94|0.9419
73905861|NCT02611960|147342608|SUPERIORITY||Difference in Percentage|-1.9||||0.63479|TWO_SIDED|95.0|-12.7|8.9||One-sided p-value for testing. H0: difference in percentage = 0 versus H1: difference in percentage \> 0.|Stratified Miettinen and Nurminen Method|||Comparison based on Miettinen \& Nurminen method stratified by presence of liver metastasis.||8.9|-12.7|0.63479
73905862|NCT02476422|147342651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2||||0.211|TWO_SIDED|95.0|-1.8|8.3|||ANCOVA|||||8.3|-1.8|0.211
73905863|NCT01288027|147342664|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||one sample t-test|||Statistical significance for change from Baseline was measured using one sample t-test||||0.1860
73905864|NCT00760214|147342671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||<|0.001|TWO_SIDED|95.0|-11.04|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-5.78|-11.04|<.001
73905865|NCT00760214|147342671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.03|||<|0.001|TWO_SIDED|95.0|-11.66|-6.39||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-6.39|-11.66|<.001
73905866|NCT00760214|147342672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.31|||<|0.001|TWO_SIDED|95.0|-6.85|-3.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-3.78|-6.85|<.001
74085060|NCT04443569|147723730|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Post-Op Day 3||||0.07
73855745|NCT00778258|147258259|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Kruskal-Wallis|||||||0.09
73855746|NCT00778258|147258259|SUPERIORITY_OR_OTHER|||||||0.01||||||Null hypothesis is that correlation = 0|Spearman's Correlation|||||||0.01
73855747|NCT00778258|147258260|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Analysis on Betalactoglobulin||||<0.01
73855748|NCT00778258|147258260|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Betalactoglobulin IgE||||<0.01
73855749|NCT00778258|147258260|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Analysis on Casein IgE||||<0.01
73855750|NCT00778258|147258260|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Casein IgE||||<0.01
73855751|NCT00778258|147258260|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Analysis on Cow's Milk IgE||||<0.01
73855752|NCT00778258|147258260|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Cow's Milk IgE||||<0.01
73855753|NCT00778258|147258261|SUPERIORITY_OR_OTHER|||||||0.01|||||||Kruskal-Wallis|||Analysis on Max Basophil Assessment||||0.01
73855754|NCT00778258|147258261|SUPERIORITY_OR_OTHER|||||||0.22||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Max Basophil Assessment||||0.22
73855755|NCT00778258|147258261|SUPERIORITY_OR_OTHER|||||||0.59|||||||Kruskal-Wallis|||Analysis on Tregs||||0.59
73855756|NCT00778258|147258261|SUPERIORITY_OR_OTHER|||||||0.32||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Tregs||||0.32
73855757|NCT00778258|147258262|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Kruskal-Wallis|||||||0.50
73855758|NCT00778258|147258263|SUPERIORITY_OR_OTHER|||||||0.033||||||Correlation = -0.18|Spearman Correlation|||Baseline Comparison||||0.033
74085061|NCT04443569|147723730|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Post-Op Day 4||||0.09
74085062|NCT04443569|147723731|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
73855759|NCT00778258|147258263|SUPERIORITY_OR_OTHER|||||||0.002||||||Correlation = -0.34|Spearman Correlation|||Month 12 Comparison||||0.002
74085063|NCT02051595|147723812|SUPERIORITY_OR_OTHER||estimate (beta) from mixed model|-0.068|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|-0.098|-0.039||A priori threshold was set to p \< 0.05.|Mixed Models Analysis|Analyses modeled change in vancomycin concentrations (independent variable defined by time). Analyses were adjusted for covariates.|Negative beta value indicates that vancomycin concentration decreased following cardiopulmonary bypass (CPB).|||-0.039|-0.098|<0.0001
73855760|NCT00778258|147258263|SUPERIORITY_OR_OTHER|||||||0.156||||||Correlation = -0.20|Spearman Correlation|||Month 24 Comparison||||0.156
73855761|NCT00778258|147258263|SUPERIORITY_OR_OTHER|||||||0.077||||||Correlation = -0.27|Spearman Correlation|||Month 36 Comparison||||0.077
73855762|NCT00778258|147258264|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||36 Month Comparison||||<0.01
73855763|NCT01926041|147258271|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.008|TWO_SIDED|95.0|0.48|0.84||Statistical significance levels were determined by two-tailed tests (P \< 0.05).|Regression, Cox|||||0.84|0.48|0.008
73855764|NCT01926041|147258272|SUPERIORITY||Cox Proportional Hazard|1.85||||0.023|TWO_SIDED|95.0|1.13|3.04||Statistical significance levels were determined by two-tailed tests (P \< 0.05).|Regression, Cox|||||3.04|1.13|0.023
73855765|NCT01926041|147258278|OTHER||Beta Coefficient|-0.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
73855766|NCT03111550|147258313|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for corneal edema)||||||0.02041|ONE_SIDED||||||Exact test on binomial distribution|||||||0.02041
73855767|NCT03111550|147258314|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for retinal detachment)||||||0.1969|ONE_SIDED|||||For ZQR00 retinal detachment|Exact test on binomial distribution|||||||0.1969
73855768|NCT03111550|147258314|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.4655|ONE_SIDED|||||For ZHR00 secondary surgical intervention|Exact test of binomial distribution|||||||0.4655
73855769|NCT03111550|147258314|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.021|ONE_SIDED|||||For ZQR00 secondary surgical intention|Exact test on binomial distribution|||||||0.0210
73855770|NCT03111550|147258314|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.4698|ONE_SIDED|||||For ZXR00 secondary surgical intervention|Exact test on binomial distribution|||||||0.4698
73855771|NCT02438384|147258330|SUPERIORITY||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|1.2|2.1||||||||2.1|1.2|
73855772|NCT02438384|147258330|SUPERIORITY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.6|1.6||||||||1.6|0.6|
73855773|NCT01579565|147258371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.049||0.0001||95.0|0.494|0.686||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 - Placebo) is adjusted for the randomization strata.||||0.686|0.494|0.0001
73855774|NCT01579565|147258372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.58|STANDARD_ERROR_OF_MEAN|1.192||0.0002||95.0|-6.917|-2.244||p-value is based on the generalized CMH test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 - Placebo) is adjusted for the randomization strata.||||-2.244|-6.917|0.0002
73855775|NCT01579565|147258373|SUPERIORITY_OR_OTHER|||||||0.0001||||||Chi-square test.|Chi-squared|||||||0.0001
73855776|NCT01579565|147258374|SUPERIORITY_OR_OTHER|||||||0.0001||||||Chi-square test|Chi-squared|||||||0.0001
73855777|NCT01579565|147258375|SUPERIORITY_OR_OTHER|||||||0.076||||||Chi-square test|Chi-squared|||||||0.0760
73855778|NCT01579565|147258376|SUPERIORITY_OR_OTHER|||||||0.0806||||||Chi-square test|Chi-squared|||||||0.0806
73855779|NCT01579565|147258377|SUPERIORITY_OR_OTHER|||||||0.0002||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.0002
73855780|NCT01579565|147258378|SUPERIORITY_OR_OTHER|||||||0.3923||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.3923
73855781|NCT01579565|147258379|SUPERIORITY_OR_OTHER|||||||0.006||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.0060
73905867|NCT00760214|147342672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.66|||<|0.001|TWO_SIDED|95.0|-7.21|-4.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-4.12|-7.21|<.001
73855782|NCT01579565|147258380|SUPERIORITY_OR_OTHER|||||||0.3286||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.3286
73855783|NCT01579565|147258381|SUPERIORITY_OR_OTHER|||||||0.2361||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata.|Wilcoxon rank-sum test|||||||0.2361
73855784|NCT03040011|147258383|SUPERIORITY|||||||0.39|||||||Kruskal-Wallis|||||||0.39
73855785|NCT03040011|147258384|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||||||0.25
73855786|NCT03040011|147258385|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||||||0.17
73855787|NCT03040011|147258386|SUPERIORITY|||||||0.45|||||||Kruskal-Wallis|||||||0.45
73855788|NCT03040011|147258387|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||||||0.54
73855789|NCT03040011|147258388|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.80
73855790|NCT03040011|147258389|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
73855791|NCT03040011|147258390|SUPERIORITY|||||||0.64|||||||Chi-squared|||||||0.64
73855792|NCT03040011|147258391|SUPERIORITY|||||||0.41|||||||Kruskal-Wallis|||||||0.41
73855793|NCT03040011|147258393|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
73855794|NCT03040011|147258394|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
73855795|NCT03040011|147258395|SUPERIORITY|||||||0.49|||||||Chi-squared|||||||0.49
73855796|NCT03040011|147258396|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
73855797|NCT03040011|147258397|SUPERIORITY|||||||0.35|||||||Kruskal-Wallis|||||||0.35
73855798|NCT03040011|147258398|SUPERIORITY|||||||0.32|||||||Kruskal-Wallis|||||||0.32
73855799|NCT03040011|147258399|SUPERIORITY|||||||0.18|||||||Kruskal-Wallis|||||||0.18
73855800|NCT03040011|147258400|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
73855801|NCT03040011|147258401|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||||||0.40
73855802|NCT03040011|147258402|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.44
73855803|NCT03817463|147258422|OTHER||Adjusted Hazard Ratio|0.7|||<|0.005|TWO_SIDED|95.0|0.6|0.83|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-(broad+specific)||0.83|0.60|<0.005
73855804|NCT03817463|147258422|OTHER||Adjusted Hazard Ratio|0.66|||<|0.005|TWO_SIDED|95.0|0.57|0.78|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline||HHF-(broad + specific).||0.78|0.57|<0.005
73855805|NCT03817463|147258423|OTHER||Ajusted hazard ratio|0.75|||<|0.005|TWO_SIDED|95.0|0.69|0.81|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-broad.||0.81|0.69|<0.005
73855806|NCT03817463|147258423|OTHER||Ajusted hazard ratio|0.78|||<|0.005|TWO_SIDED|95.0|0.69|0.88|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-broad.||0.88|0.69|<0.005
73855807|NCT03817463|147258424|OTHER||Adjusted Hazard Ratio|0.68|||<|0.005|TWO_SIDED|95.0|0.56|0.83|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-specific. Hazards ratios reported include data from all countries with non-missing values.||0.83|0.56|<0.005
73855808|NCT03817463|147258424|OTHER||Adjusted Hazard Ratio|0.64|||<|0.005|TWO_SIDED|95.0|0.51|0.81|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-specific. Hazards ratios reported include data from all countries with non-missing values.||0.81|0.51|<0.005
73855809|NCT03817463|147258425|OTHER||Adjusted Hazard Ratio|0.55|||<|0.005|TWO_SIDED|95.0|0.48|0.63|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.63|0.48|<0.005
73855810|NCT03817463|147258425|OTHER||Adjusted Hazard Ratio|0.59|||<|0.005|TWO_SIDED|95.0|0.54|0.65|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.65|0.54|<0.005
73855811|NCT03817463|147258426|OTHER||Adjusted Hazard Ratio|0.65|||<|0.05|TWO_SIDED|95.0|0.56|0.76|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.76|0.56|<0.05
73855812|NCT03817463|147258426|OTHER||Adjusted Hazard Ratio|0.66|||<|0.005|TWO_SIDED|95.0|0.61|0.72|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.72|0.61|<0.005
73855813|NCT03817463|147258427|OTHER||Adjusted Hazard Ratio|0.72|||<|0.005|TWO_SIDED|95.0|0.64|0.82|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.82|0.64|<0.005
73855814|NCT03817463|147258427|OTHER||Adjusted Hazard Ratio|0.72|||<|0.005|TWO_SIDED|95.0|0.66|0.78|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.78|0.66|<0.005
73855815|NCT03817463|147258428|OTHER||Adjusted Hazard Ratio|1.02||||0.816|TWO_SIDED|95.0|0.88|1.18|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.18|0.88|0.816
73855816|NCT03817463|147258428|OTHER||Adjusted Hazard Ratio|0.87||||0.013|TWO_SIDED|95.0|0.78|0.97|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.97|0.78|0.013
73855817|NCT03817463|147258429|OTHER||Adjusted Hazard Ratio|0.82|||<|0.011|TWO_SIDED|95.0|0.71|0.96|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.96|0.71|<0.011
73905868|NCT00760214|147342673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.82|||<|0.001|TWO_SIDED|95.0|-7.64|-2.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.01|-7.64|<.001
74025468|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|-4.86|||||TWO_SIDED|95.0|-14.4|4.39||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.39|-14.40|
74025469|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|-19.0|||||TWO_SIDED|95.0|-30.1|-7.16||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-7.16|-30.10|
73855818|NCT03817463|147258429|OTHER||Adjusted Hazard Ratio|0.84||||0.064|TWO_SIDED|95.0|0.69|1.01|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.01|0.69|0.064
73855819|NCT03817463|147258430|OTHER||Adjusted Hazard Ratio|0.59|||<|0.005|TWO_SIDED|95.0|0.42|0.84|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.84|0.42|<0.005
73855820|NCT03817463|147258430|OTHER||Adjusted Hazard Ratio|0.6|||<|0.005|TWO_SIDED|95.0|0.49|0.72|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.72|0.49|<0.005
73855821|NCT03817463|147258431|OTHER||Adjusted Hazard Ratio|0.54|||<|0.005|TWO_SIDED|95.0|0.46|0.64|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.64|0.46|<0.005
73855822|NCT03817463|147258431|OTHER||Adjusted Hazard Ratio|0.56|||<|0.005|TWO_SIDED|95.0|0.47|0.66|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.66|0.47|<0.005
73855823|NCT03817463|147258432|OTHER||Adjusted Hazard Ratio|0.95||||0.545|TWO_SIDED|95.0|0.81|1.11|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.11|0.81|0.545
73855824|NCT03817463|147258432|OTHER||Adjusted Hazard Ratio|0.91||||0.036|TWO_SIDED|95.0|0.83|0.99|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.99|0.83|0.036
73855825|NCT03817463|147258433|OTHER||Adjusted Hazard Ratio|0.93||||0.353|TWO_SIDED|95.0|0.79|1.09|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.09|0.79|0.353
73855826|NCT03817463|147258433|OTHER||Adjusted Hazard Ratio|0.9||||0.197|TWO_SIDED|95.0|0.78|1.05|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.05|0.78|0.197
73855827|NCT03817463|147258434|OTHER||Adjusted Hazard Ratio|0.43|||<|0.005|TWO_SIDED|95.0|0.3|0.63|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.63|0.30|<0.005
73855828|NCT03817463|147258434|OTHER||Adjusted Hazard Ratio|0.27|||<|0.005|TWO_SIDED|95.0|0.16|0.44|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.44|0.16|<0.005
73855829|NCT03817463|147258435|OTHER||Adjusted Hazard Ratio|1.05||||0.535|TWO_SIDED|95.0|0.89|1.25|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.25|0.89|0.535
73855830|NCT03817463|147258435|OTHER||Adjusted Hazard Ratio|0.98||||0.85|TWO_SIDED|95.0|0.84|1.15|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.15|0.84|0.850
73855831|NCT03817463|147258436|OTHER||Adjusted Hazard Ratio|1.03||||0.828|TWO_SIDED|95.0|0.81|1.31|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.31|0.81|0.828
73855832|NCT03817463|147258436|OTHER||Adjusted Hazard Ratio|1.01||||0.944|TWO_SIDED|95.0|0.72|1.42|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.42|0.72|0.944
73855833|NCT03817463|147258437|OTHER||Adjusted Hazard Ratio|0.94||||0.642|TWO_SIDED|95.0|0.73|1.22|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.22|0.73|0.642
73855834|NCT03817463|147258437|OTHER||Adjusted Hazard Ratio|0.89||||0.417|TWO_SIDED|95.0|0.66|1.19|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.19|0.66|0.417
73855835|NCT03817463|147258438|OTHER||Adjusted Hazard Ratio|0.89||||0.091|TWO_SIDED|95.0|0.77|1.02|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.02|0.77|0.091
73855836|NCT03817463|147258439|OTHER||Adjusted Hazard Ratio|1.97|||<|0.005|TWO_SIDED|95.0|1.28|3.03|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||3.03|1.28|<0.005
73855837|NCT03817463|147258440|OTHER||Adjusted Hazard Ratio|0.95||||0.654|TWO_SIDED|95.0|0.75|1.2|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.20|0.75|0.654
73855838|NCT03817463|147258441|OTHER||Adjusted Hazard Ratio|0.78||||0.233|TWO_SIDED|95.0|0.52|1.17|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.17|0.52|0.233
73855839|NCT03817463|147258442|OTHER||Adjusted Hazard Ratio|0.56|||<|0.005|TWO_SIDED|95.0|0.38|0.82|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.82|0.38|<0.005
74025470|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|-12.19|||||TWO_SIDED|95.0|-21.66|-3.26||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-3.26|-21.66|
73963484|NCT01780298|147462599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.661||||0.0018|TWO_SIDED|95.0|7.997|33.324|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||33.324|7.997|0.0018
73963485|NCT01780298|147462599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.91||||0.0015|TWO_SIDED|95.0|5.534|22.286|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||22.286|5.534|0.0015
73963486|NCT01780298|147462599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.877||||0.1847|TWO_SIDED|95.0|-2.886|14.639|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||14.639|-2.886|0.1847
73963487|NCT01780298|147462599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.787||||0.0003|TWO_SIDED|95.0|9.536|30.038|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||30.038|9.536|0.0003
73963488|NCT01780298|147462600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2979.725||||0.1981|TWO_SIDED|95.0|-7560.258|1600.808|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1600.808|-7560.258|0.1981
73963489|NCT01780298|147462600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2317.131||||0.1956|TWO_SIDED|95.0|-1224.786|5859.048|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||5859.048|-1224.786|0.1956
73963490|NCT01780298|147462600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2396.589||||0.2077|TWO_SIDED|95.0|-1367.692|6160.87|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||6160.870|-1367.692|0.2077
73963491|NCT01780298|147462600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5296.856||||0.1154|TWO_SIDED|95.0|-11930.19|1336.478|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||1336.478|-11930.190|0.1154
73963492|NCT01780298|147462600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-79.458||||0.8095|TWO_SIDED|95.0|-736.151|577.234|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||577.234|-736.151|0.8095
74085064|NCT00407745|147723813|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.198||0.0032|TWO_SIDED|95.0|-0.98|-0.2||Significance was declared if the 2-tailed test for the difference between treatment groups was significant at the 0.05 level.|ANCOVA|||"Null hypothesis - the mean DAAC for the pregabalin group is equal to the mean DAAC for the placebo group; Alternative hypothesis - the mean DAAC for the placebo group differs from the mean DAAC for the pregabalin group.~ANCOVA model included baseline severity of pain and Baseline Pain Catastrophizing Scale (PCS) Total Score as covariates and pooled center and treatment as fixed (class) cofactors."||-0.20|-0.98|0.0032
73855840|NCT03817463|147258443|OTHER||Rate Ratio|0.74|||||TWO_SIDED|95.0|0.69|0.8|||||Poisson regression model was used.|Emergency room visits - Finland||0.80|0.69|
73963493|NCT01780298|147462600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5376.314||||0.1113|TWO_SIDED|95.0|-12030.714|1278.085|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||1278.085|-12030.714|0.1113
73855841|NCT03817463|147258443|OTHER||Rate Ratio|0.9|||||TWO_SIDED|95.0|0.59|1.38|||||Poisson regression model was used.|Emergency room visits - Japan||1.38|0.59|
73855842|NCT03817463|147258443|OTHER||Rate Ratio|0.91|||||TWO_SIDED|95.0|0.82|1.0|||||Poisson regression model was used.|Emergency room visits - South Korea||1.00|0.82|
73963494|NCT01780298|147462601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.015|||<|0.0001|TWO_SIDED|95.0|4.51|7.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||7.521|4.510|<0.0001
73963495|NCT01780298|147462601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.845|||<|0.0001|TWO_SIDED|95.0|3.379|6.31|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||6.310|3.379|<0.0001
73963496|NCT01780298|147462601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.454|||<|0.0001|TWO_SIDED|95.0|1.923|4.984|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||4.984|1.923|<0.0001
73963497|NCT01780298|147462601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.171||||0.0418|TWO_SIDED|95.0|0.045|2.296|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||2.296|0.045|0.0418
73963498|NCT01780298|147462601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.391||||0.0357|TWO_SIDED|95.0|0.096|2.686|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||2.686|0.096|0.0357
73963499|NCT01780298|147462601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.562||||0.0001|TWO_SIDED|95.0|1.303|3.82|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||3.820|1.303|0.0001
74025471|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
74025472|NCT01193335|147604177|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
74025473|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.62|1.02||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.02|0.62|
74025474|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|0.56|||||TWO_SIDED|95.0|0.38|0.82||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.38|
74025475|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|0.74|||||TWO_SIDED|95.0|0.59|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.93|0.59|
74025476|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|1.23|||||TWO_SIDED|95.0|0.92|1.65||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.65|0.92|
74025477|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.8|1.25||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.25|0.80|
73855843|NCT03817463|147258443|OTHER||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||||Poisson regression model was used.|Emergency room visit - Spain||0.87|0.59|
73855844|NCT03817463|147258443|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.87|1.01|||||Poisson regression model was used.|Emergency room visit - Sweden||1.01|0.87|
73855845|NCT03817463|147258443|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.8|0.93|||||Poisson regression model was used.|Emergency room visit - Taiwan||0.93|0.80|
73855846|NCT03817463|147258443|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.75|0.85|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Finland||0.85|0.75|
73855847|NCT03817463|147258443|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.84|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Japan||0.84|0.68|
73855848|NCT03817463|147258443|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.69|0.82|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - South Korea||0.82|0.69|
73855849|NCT03817463|147258443|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.78|0.94|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Norway||0.94|0.78|
73855850|NCT03817463|147258443|OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.66|0.89|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Spain||0.89|0.66|
73855851|NCT03817463|147258443|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.81|0.93|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Sweden||0.93|0.81|
73855852|NCT03817463|147258443|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.74|0.86|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Taiwan||0.86|0.74|
73855853|NCT03817463|147258443|OTHER||Rate Ratio|0.68|||||TWO_SIDED|95.0|0.64|0.71|||||Poisson regression model was used.|All-cause hospital admissions||0.71|0.64|
73855854|NCT03817463|147258443|OTHER||Rate Ratio|0.69|||||TWO_SIDED|95.0|0.63|0.76|||||Poisson regression model was used.|For all-cause hospital admissions - Japan||0.76|0.63|
73855855|NCT03817463|147258443|OTHER||Rate Ratio|0.7|||||TWO_SIDED|95.0|0.66|0.75|||||Poisson regression model was used.|All-cause hospital admissions - South Korea||0.75|0.66|
73855856|NCT03817463|147258443|OTHER||Rate Ratio|0.81|||||TWO_SIDED|95.0|0.77|0.85|||||Poisson regression model was used.|All-cause hospital admissions - Norway||0.85|0.77|
73855857|NCT03817463|147258443|OTHER||Rate Ratio|0.68|||||TWO_SIDED|95.0|0.6|0.77|||||Poisson regression model was used.|All-cause hospital admissions - Spain||0.77|0.60|
73855858|NCT03817463|147258443|OTHER||Rate Ratio|0.85|||||TWO_SIDED|95.0|0.8|0.89|||||Poisson regression model was used.|All-cause hospital admissions - Sweden||0.89|0.80|
73855859|NCT03817463|147258443|OTHER||Rate Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.87||||||All-cause hospital admissions - Taiwan||0.87|0.72|
73855860|NCT03817463|147258443|OTHER||Rate Ratio|0.78|||||TWO_SIDED|95.0|0.77|0.79|||||Poisson regression model was used.|Outpatient healthcare visits - Finland||0.79|0.77|
73855861|NCT03817463|147258443|OTHER||Rate Ratio|0.95|||||TWO_SIDED|95.0|0.94|0.97|||||Poisson regression model was used.|Outpatient healthcare visits - Japan||0.97|0.94|
73855862|NCT03817463|147258443|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.96|0.97|||||Poisson regression model was used.|Outpatient healthcare visits - South Korea||0.97|0.96|
73855863|NCT03817463|147258443|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.94|0.97||||||Outpatient healthcare visits - Norway||0.97|0.94|
73855864|NCT03817463|147258443|OTHER||Rate Ratio|0.88|||||TWO_SIDED|95.0|0.85|0.91|||||Poisson regression model was used.|Outpatient healthcare visit - Spain||0.91|0.85|
73855865|NCT03817463|147258443|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.94|0.98|||||Poisson regression model was used.|Outpatient healthcare visits - Sweden||0.98|0.94|
73905869|NCT00760214|147342673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.47||||0.002|TWO_SIDED|95.0|-7.27|-1.66||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.66|-7.27|0.002
73905870|NCT00760214|147342674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.77||||0.003|TWO_SIDED|95.0|-4.61|-0.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.94|-4.61|0.003
73905871|NCT00760214|147342674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.06||||0.001|TWO_SIDED|95.0|-4.89|-1.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.24|-4.89|0.001
73905872|NCT00760214|147342675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77||||0.017|TWO_SIDED|95.0|-6.87|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.68|-6.87|0.017
73905873|NCT00760214|147342675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.43||||0.029|TWO_SIDED|95.0|-6.5|-0.36||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.36|-6.50|0.029
73905874|NCT00760214|147342676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06||||0.052|TWO_SIDED|95.0|-4.15|0.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||0.02|-4.15|0.052
73905875|NCT00760214|147342676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42||||0.022|TWO_SIDED|95.0|-4.49|-0.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.35|-4.49|0.022
73905876|NCT00760214|147342677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53||||0.003|TWO_SIDED|95.0|-7.46|-1.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.59|-7.46|0.003
73905877|NCT00760214|147342677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26||||0.004|TWO_SIDED|95.0|-7.18|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.35|-7.18|0.004
73905878|NCT00760214|147342678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64||||0.008|TWO_SIDED|95.0|-4.6|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.68|-4.60|0.008
74025478|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|0.72|||||TWO_SIDED|95.0|0.58|0.9||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.58|
73905879|NCT00760214|147342678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.98||||0.003|TWO_SIDED|95.0|-4.93|-1.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.04|-4.93|0.003
73905880|NCT00760214|147342679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-9.12|-2.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.77|-9.12|<.001
73905881|NCT00760214|147342679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||<|0.001|TWO_SIDED|95.0|-8.96|-2.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.67|-8.96|<.001
73855866|NCT03817463|147258443|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.94|1.0|||||Poisson regression model was used.|Outpatient healthcare visits - Taiwan||1.00|0.94|
73855867|NCT03817463|147258444|OTHER||Rate Ratio|0.91|||||TWO_SIDED|95.0|0.89|0.94|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - Japan||0.94|0.89|
73855868|NCT03817463|147258444|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.81|0.93|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - South Korea||0.93|0.81|
73855869|NCT03817463|147258444|OTHER||Rate Ratio|1.09|||||TWO_SIDED|95.0|1.08|1.11|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - Taiwan||1.11|1.08|
73855870|NCT03817463|147258444|OTHER||Rate Ratio|1.11|||||TWO_SIDED|95.0|1.1|1.12|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Finland||1.12|1.10|
73905882|NCT00760214|147342680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.01||||0.006|TWO_SIDED|95.0|-5.15|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.88|-5.15|0.006
73905883|NCT00760214|147342680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77|||<|0.001|TWO_SIDED|95.0|-5.89|-1.65||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.65|-5.89|<.001
73905884|NCT00760214|147342681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.87|||<|0.001|TWO_SIDED|95.0|-12.15|-5.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-5.60|-12.15|<.001
73855871|NCT03817463|147258444|OTHER||Rate Ratio|0.82|||||TWO_SIDED|95.0|0.81|0.83|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Japan||0.83|0.81|
73855872|NCT03817463|147258444|OTHER||Rate Ratio|0.99|||||TWO_SIDED|95.0|0.99|1.0|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - South Korea||1.00|0.99|
73855873|NCT03817463|147258444|OTHER||Rate Ratio|1.12|||||TWO_SIDED|95.0|1.11|1.14|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Norway||1.14|1.11|
73855874|NCT03817463|147258444|OTHER||Rate Ratio|1.26|||||TWO_SIDED|95.0|1.25|1.27|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Sweden||1.27|1.25|
73855875|NCT03817463|147258444|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.02|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Taiwan||1.02|0.98|
73905885|NCT00760214|147342681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2|||<|0.001|TWO_SIDED|95.0|-11.46|-4.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-4.95|-11.46|<.001
73905886|NCT00760214|147342682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.68|||<|0.001|TWO_SIDED|95.0|-8.19|-3.17||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-3.17|-8.19|<.001
73905887|NCT00760214|147342682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.32|||<|0.001|TWO_SIDED|95.0|-7.81|-2.82||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.82|-7.81|<.001
73905888|NCT01086423|147342697|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.68|||||TWO_SIDED|95.0|-1.88|3.76||||||To demonstrate that the immunogenicity of Infanrix™ -IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-D, one month after the third vaccine dose.||3.76|-1.88|
73905889|NCT01086423|147342697|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.56|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-T, one month after the third vaccine dose.||2.56|-2.56|
73905890|NCT01086423|147342698|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-7.93|||||TWO_SIDED|95.0|-14.44|-2.13||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRP antibodies, one month after the third vaccine dose.||-2.13|-14.44|
73905891|NCT01086423|147342699|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 1 antibodies, one month after the third vaccine dose.||2.56|-2.51|
73905892|NCT01086423|147342699|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 2 antibodies, one month after the third vaccine dose.||2.56|-2.51|
73905893|NCT01086423|147342699|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 3 antibodies, one month after the third vaccine dose.||2.56|-2.51|
73905894|NCT01086423|147342700|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.68|||||TWO_SIDED|95.0|-3.74|1.89||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PT antigens, one month after the third vaccine dose.||1.89|-3.74|
73905895|NCT01086423|147342700|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-2.7|||||TWO_SIDED|95.0|-6.75|-0.11||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-FHA antigens, one month after the third vaccine dose.||-0.11|-6.75|
73905896|NCT01086423|147342700|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.67|||||TWO_SIDED|95.0|-4.6|3.04||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRN antigens, one month after the third vaccine dose.||3.04|-4.6|
73905897|NCT00749515|147342709|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<.001
73905898|NCT00749515|147342710|OTHER|||||||0.275|||||||t-test, 2 sided|||||||.275
73905899|NCT00749515|147342711|OTHER|||||||0.178|||||||t-test, 2 sided|||||||.178
73905900|NCT00749515|147342712|OTHER|||||||0.062|||||||t-test, 2 sided|||||||.062
73905901|NCT00749515|147342713|OTHER|||||||0.104|||||||t-test, 2 sided|||||||.104
73905902|NCT01130103|147342718|SUPERIORITY_OR_OTHER||incident rate ratio|0.5||||0.01|TWO_SIDED|95.0|0.3|0.85|||Mixed Models Analysis|||caps total score at weeks 5 and 10||.85|.30|.01
73905903|NCT01130103|147342718|SUPERIORITY_OR_OTHER||incident rate ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.43|0.74|||Mixed Models Analysis|||rate of change in CAPS total from week 5 to week 10||.74|.43|<.001
73905904|NCT01130103|147342722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.6||||0.03|TWO_SIDED|95.0|1.23|129.0|||Mixed Models Analysis|||treatment group effect: remission rate at weeks 5 and 10||129|1.23|.03
73855876|NCT03817463|147258444|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|1.01|1.02|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Finland||1.02|1.01|
73855877|NCT03817463|147258444|OTHER||Rate Ratio|0.83|||||TWO_SIDED|95.0|0.82|0.84|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Japan||0.84|0.82|
73855878|NCT03817463|147258444|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - South Korea||1.01|0.99|
73855879|NCT03817463|147258444|OTHER||Rate Ratio|0.93|||||TWO_SIDED|95.0|0.92|0.93|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Norway||0.93|0.92|
73855880|NCT03817463|147258444|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.84|0.87|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Spain||0.87|0.84|
73855881|NCT03817463|147258444|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Sweden||1.00|1.00|
73855882|NCT03817463|147258445|OTHER||Rate Ratio|0.89|||||TWO_SIDED|95.0|0.83|0.94|||||Poisson regression model was used.|Total cost - Finland||0.94|0.83|
73855883|NCT03817463|147258445|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.12|||||Poisson regression model was used.|Total costs - Norway||1.12|0.86|
73855884|NCT03817463|147258445|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.92|1.05|||||Poisson regression model was used.|Total costs - Sweden||1.05|0.92|
73855885|NCT03817463|147258446|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.8|0.88|||||Poisson regression model was used.|||0.88|0.80|
73855886|NCT03817463|147258447|OTHER||Rate Ratio|0.76|||||TWO_SIDED|95.0|0.34|1.68|||||Poisson regression model was used.|Total costs - South Korea||1.68|0.34|
73855887|NCT03817463|147258448|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.92|1.03|||||Poisson regression model was used.|Total costs - Taiwan||1.03|0.92|
73855888|NCT01159171|147258517|SUPERIORITY_OR_OTHER|||||||0.0047||0.0||||One-sided p-value|One sample exact binomial test|||||||0.0047
73905905|NCT01130103|147342722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.8||||0.007|TWO_SIDED|95.0|2.44|176.0|||Mixed Models Analysis|||rate of change over time in remission rate from week 5 to 10||176|2.44|0.007
73855889|NCT01461928|147258529|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.41|TWO_SIDED|95.0|0.37|1.53||Power at time of final analysis was less than 40%. Final analysis was not able to address its primary objective.|Stratified Long-rank|||The stratified log rank test p-value was derived using the following randomization stratification strata : Follicular Lymphoma International Prognostic Index (FLIPI) risk category (low, intermediate, high) and indolent NHL subtype (follicular lymphoma, non-follicular lymphoma). Power at time of final analysis was less than 40%. Final analysis was not able to address it's primary objective.||1.53|0.37|= 0.410
73855890|NCT01018134|147258538|SUPERIORITY_OR_OTHER|||||||0.4261|||||||t-test, 1 sided|||||||0.4261
73855891|NCT01018134|147258538|SUPERIORITY_OR_OTHER|||||||0.4219|||||||t-test, 1 sided|||||||0.4219
73855892|NCT01018134|147258538|SUPERIORITY_OR_OTHER|||||||0.1826|||||||t-test, 1 sided|||||||0.1826
73855893|NCT01018134|147258538|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0090
73855894|NCT01018134|147258538|SUPERIORITY_OR_OTHER|||||||0.3421|||||||t-test, 1 sided|||||||0.3421
73855895|NCT01018134|147258538|SUPERIORITY_OR_OTHER|||||||0.01||||||Statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0100
73855896|NCT01018134|147258538|SUPERIORITY_OR_OTHER|||||||0.2103|||||||t-test, 1 sided|||||||0.2103
73855897|NCT01018134|147258538|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 1 sided|||||||0.1200
73855898|NCT01018134|147258539|SUPERIORITY_OR_OTHER|||||||0.2631|||||||t-test, 1 sided|||||||0.2631
73855899|NCT01018134|147258539|SUPERIORITY_OR_OTHER|||||||0.2968|||||||t-test, 1 sided|||||||0.2968
73855900|NCT01018134|147258539|SUPERIORITY_OR_OTHER|||||||0.0186||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0186
73855901|NCT01018134|147258539|SUPERIORITY_OR_OTHER|||||||0.0361||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0361
73855902|NCT01018134|147258539|SUPERIORITY_OR_OTHER|||||||0.007||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0070
73855903|NCT01018134|147258539|SUPERIORITY_OR_OTHER|||||||0.1583|||||||t-test, 1 sided|||||||0.1583
73855904|NCT01018134|147258539|SUPERIORITY_OR_OTHER|||||||0.2078|||||||t-test, 1 sided|||||||0.2078
73855905|NCT01018134|147258539|SUPERIORITY_OR_OTHER|||||||0.2878|||||||t-test, 1 sided|||||||0.2878
73855906|NCT01018134|147258540|SUPERIORITY_OR_OTHER|||||||0.2713|||||||Wilcoxon (Mann-Whitney)|||||||0.2713
73855907|NCT01018134|147258540|SUPERIORITY_OR_OTHER|||||||0.2689|||||||Wilcoxon (Mann-Whitney)|||||||0.2689
73855908|NCT01018134|147258540|SUPERIORITY_OR_OTHER|||||||0.0419|||||||Wilcoxon (Mann-Whitney)|||||||0.0419
73855909|NCT01018134|147258540|SUPERIORITY_OR_OTHER|||||||0.0309|||||||Wilcoxon (Mann-Whitney)|||||||0.0309
73855910|NCT01018134|147258540|SUPERIORITY_OR_OTHER|||||||0.1126|||||||Wilcoxon (Mann-Whitney)|||||||0.1126
73855911|NCT01018134|147258540|SUPERIORITY_OR_OTHER|||||||0.0033|||||||Wilcoxon (Mann-Whitney)|||||||0.0033
73855912|NCT01018134|147258540|SUPERIORITY_OR_OTHER|||||||0.4967|||||||Wilcoxon (Mann-Whitney)|||||||0.4967
73855913|NCT01018134|147258540|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Wilcoxon (Mann-Whitney)|||||||0.0749
73905906|NCT02992132|147342738|SUPERIORITY||Difference in LSM|5.1|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-4.8|15.0||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.||15.0|-4.8|
73905907|NCT02992132|147342738|SUPERIORITY||Difference in LSM|1.0|STANDARD_ERROR_OF_MEAN|4.8|||TWO_SIDED|95.0|-8.5|10.5||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.||10.5|-8.5|
73905908|NCT00620464|147342740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||90.0||||Applies to all parameters.|Bioequivalence Testing|||||||0.05
74025479|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|0.64|||||TWO_SIDED|95.0|0.47|0.86||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.86|0.47|
74025480|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|0.7|||||TWO_SIDED|95.0|0.55|0.89||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.89|0.55|
73855914|NCT01018134|147258541|SUPERIORITY_OR_OTHER|||||||0.2442|||||||Wilcoxon (Mann-Whitney)|||||||0.2442
73855915|NCT01018134|147258541|SUPERIORITY_OR_OTHER|||||||0.2664|||||||Wilcoxon (Mann-Whitney)|||||||0.2664
73855916|NCT01018134|147258541|SUPERIORITY_OR_OTHER|||||||0.1328|||||||Wilcoxon (Mann-Whitney)|||||||0.1328
73855917|NCT01018134|147258541|SUPERIORITY_OR_OTHER|||||||0.0528|||||||Wilcoxon (Mann-Whitney)|||||||0.0528
73855918|NCT01018134|147258541|SUPERIORITY_OR_OTHER|||||||0.0297|||||||Wilcoxon (Mann-Whitney)|||||||0.0297
73855919|NCT01018134|147258541|SUPERIORITY_OR_OTHER|||||||0.0093|||||||Wilcoxon (Mann-Whitney)|||||||0.0093
73855920|NCT01018134|147258541|SUPERIORITY_OR_OTHER|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||||||0.2230
73855921|NCT01018134|147258541|SUPERIORITY_OR_OTHER|||||||0.1924|||||||Wilcoxon (Mann-Whitney)|||||||0.1924
73855922|NCT01018134|147258542|SUPERIORITY_OR_OTHER|||||||0.2397|||||||Wilcoxon (Mann-Whitney)|||||||0.2397
73855923|NCT01018134|147258542|SUPERIORITY_OR_OTHER|||||||0.3794|||||||Wilcoxon (Mann-Whitney)|||||||0.3794
73855924|NCT01018134|147258542|SUPERIORITY_OR_OTHER|||||||0.0383|||||||Wilcoxon (Mann-Whitney)|||||||0.0383
73855925|NCT01018134|147258542|SUPERIORITY_OR_OTHER|||||||0.0154|||||||Wilcoxon (Mann-Whitney)|||||||0.0154
73855926|NCT01018134|147258542|SUPERIORITY_OR_OTHER|||||||0.1892|||||||Wilcoxon (Mann-Whitney)|||||||0.1892
73855927|NCT01018134|147258542|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.0010
73855928|NCT01018134|147258542|SUPERIORITY_OR_OTHER|||||||0.0363|||||||Wilcoxon (Mann-Whitney)|||||||0.0363
73855929|NCT01018134|147258542|SUPERIORITY_OR_OTHER|||||||0.2162|||||||Wilcoxon (Mann-Whitney)|||||||0.2162
73855930|NCT02222909|147258543|OTHER|The significance of the difference-in-differences statistic was assessed using randomization inference, a non-parametric permutation test. Confidence intervals were determined by inversion of the test statistic.|Difference in differences|0.0182||||0.63|TWO_SIDED|95.0|-0.12|0.11||We calculated the proportion of permuted statistics with values higher in magnitude than that of the observed adjusted difference in differences (the p-value). We inverted the test statistic to determine confidence intervals.|Randomization inference||The estimation parameter is the difference between the average adjusted change in the monthly ED visits and hospital days from the pre- to post- intervention periods for the patients assigned to the iCBOs as compared to the cCBOs.|The difference between the average sum of the number of days spent in the hospital and ED visits in the past month, pre- and post-intervention, adjusted for pre- intervention variables, was calculated for each patients. The average change scores among patients assigned to each CBO defined the CBO-level outcomes. We calculated a weighted average of the CBO outcomes separately for the iCBOs and cCBOs, defining the difference-in-differences statistic as the difference between the two averages.||0.11|-0.12|0.63
73855931|NCT02242435|147258544|SUPERIORITY|||||||0.26||||||Adjusted for baseline WOMAC score.|ANCOVA|||||||0.26
73855932|NCT02242435|147258545|SUPERIORITY|||||||0.3||||||Adjustment for baseline WOMAC score.|ANCOVA|||||||0.30
73855933|NCT01981863|147258548|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
73905909|NCT00620464|147342741|SUPERIORITY_OR_OTHER_LEGACY||||||<=|0.05||95.0|||||Bioequivalence Testing|||||||<=0.05
73905910|NCT02035475|147342775|SUPERIORITY_OR_OTHER|||||||0.412|||||||McNemar|||The null hypothesis is that there is no difference in the incidence of detected lymphoceles whether the EndoWrist 1 Vessel Sealer or the Fenestrated Maryland BiPolar Instrument were used.||||0.412
73855934|NCT00117715|147258550|OTHER|||||||0.035||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(DM/DX) over time||||0.035
73855935|NCT00117715|147258551|OTHER|||||||0.194||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(3HM/DX) over time||||0.194
73855936|NCT00117715|147258552|OTHER|||||||0.831||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log ((AAMU+1MX+1MU)/1,7,U) over time||||0.831
73855937|NCT01089413|147258554|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8579|TWO_SIDED|95.0|0.7|1.54|||Regression, Cox|||||1.54|0.70|0.8579
73855938|NCT01089413|147258555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1555|TWO_SIDED|95.0|0.3|1.21|||Regression, Cox|||||1.21|0.30|0.1555
73855939|NCT02383420|147258558|SUPERIORITY_OR_OTHER|||||||0.415|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.415
73855940|NCT02383420|147258559|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.0000
73855941|NCT02526524|147258580|SUPERIORITY||LS Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.184||0.1449|TWO_SIDED|95.0|-0.63|0.09|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||0.09|-0.63|0.1449
73855942|NCT02526524|147258580|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.0643|TWO_SIDED|95.0|-0.69|0.02|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||0.02|-0.69|0.0643
73855943|NCT02526524|147258580|SUPERIORITY||LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.184||0.0214|TWO_SIDED|95.0|-0.79|-0.06|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.06|-0.79|0.0214
73855944|NCT02526524|147258580|SUPERIORITY||LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.18||0.0022|TWO_SIDED|95.0|-0.91|-0.2|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.20|-0.91|0.0022
73855945|NCT02526524|147258580|SUPERIORITY||LS Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.184|<|0.0001|TWO_SIDED|95.0|-1.39|-0.67|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.67|-1.39|<0.0001
73905911|NCT02047227|147342809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.235||||0.054|TWO_SIDED|95.0|-0.4741|0.003|||Poisson Regression Model|||||0.003|-0.4741|0.054
73905912|NCT01977937|147342817|OTHER|Differences in average pre-operative \& total post-operative average VAS scores were compared between groups using an unpaired Mann-Whitney rank sum test. Hospitalization outcomes including number of days to transition off PCA, number of days with Foley catheter, \& episodes of nausea, emesis, or POSS \> 3 were compared between groups using an unpaired two-tailed Student's t-test. Statistical significance was defined as p\<0.05 for all unpaired parametric and non-parametric comparisons.||||||0.07|||||||t-test, 2 sided|||D'Agostino \& Pearson normality test was used to assess for normal distribution. Experimental \& control groups were assessed for significant differences in age, hospital days, \& spinal levels fused using unpaired two-tailed Student's t-test. Differences in weight \& BMI were assessed using unpaired Mann-Whitney rank sum test. Differences in average VAS scores on the operative day, each post-operative day, and average total daily opioid were compared using an unpaired two-tailed Student's t-test.||||0.07
73905913|NCT01977937|147342818|OTHER|||||||0.02|||||||t-test, 2 sided|||Differences in the average total daily opioid were compared between groups using an unpaired two-tailed Student's t-test||||0.02
73905914|NCT01302379|147342835|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.05|TWO_SIDED|95.0|-97.5|97.5||No adjustment for multiple comparisons|Mixed Models Analysis|||||97.5|-97.5|<0.05
73905915|NCT02819518|147342841|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.012|TWO_SIDED|95.0|0.7|0.98||One-sided p-value based on log-rank test stratified by chemotherapy (taxane versus \[vs\] gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs. no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.98|0.70|0.0120
73963500|NCT01780298|147462602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|39.633|||<|0.0001|TWO_SIDED|95.0|33.964|45.302|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||45.302|33.964|<0.0001
73963501|NCT01780298|147462602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.792|||<|0.0001|TWO_SIDED|95.0|29.761|41.822|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||41.822|29.761|<0.0001
73963502|NCT01780298|147462602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.167|||<|0.0001|TWO_SIDED|95.0|23.445|34.888|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||34.888|23.445|<0.0001
73963503|NCT01780298|147462602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.842||||0.0418|TWO_SIDED|95.0|0.147|7.536|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||7.536|0.147|0.0418
73905916|NCT02819518|147342842|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0016|TWO_SIDED|95.0|0.62|0.91||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.91|0.62|0.0016
74025481|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|0.96|||||TWO_SIDED|95.0|0.77|1.19||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.19|0.77|
74025482|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|0.54|||||TWO_SIDED|95.0|0.4|0.72||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.40|
73905917|NCT02819518|147342843|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0018|TWO_SIDED|95.0|0.5|0.88||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.88|0.50|0.0018
73905918|NCT02819518|147342844|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0797|TWO_SIDED|95.0|0.76|1.05||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||1.05|0.76|0.0797
73963504|NCT01780298|147462602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.625||||0.0084|TWO_SIDED|95.0|1.763|11.487|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||11.487|1.763|0.0084
73963505|NCT01780298|147462602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.467|||<|0.0001|TWO_SIDED|95.0|5.888|15.045|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||15.045|5.888|<0.0001
73963506|NCT01780298|147462603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.929|||<|0.0001|TWO_SIDED|95.0|0.654|1.203|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1.203|0.654|<0.0001
74025483|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|0.61|||||TWO_SIDED|95.0|0.45|0.82||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.45|
74085065|NCT00407745|147723814|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.255||0.0066|TWO_SIDED|95.0|-1.2|-0.2||Serial gate-keeping multiple testing procedure was used. If primary comparison for DAAC was significant, then variables were assessed in a hierarchical manner. Significance was declared if unadjusted p-value was significant at 0.05 level (\<=0.05).|ANCOVA|ANCOVA model included baseline severity (pain) and baseline PCS as covariates and effects for treatment and pooled center as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.20|-1.20|0.0066
74085066|NCT00407745|147723815|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85||||0.039|TWO_SIDED|95.0|1.032|3.328||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Regression, Logistic|Logistic regression model used terms for baseline pain score and baseline PCS total score as covariate, and pooled center and treatment as cofactor.||Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group||3.328|1.032|0.0390
74085067|NCT00407745|147723816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0||||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Cochran-Mantel-Haenszel|Modified ridit transformation with the Cochran-Mantel- Haenszel test was used with adjusting for pooled center.||Null hypothesis - The raw mean score for the pregabain group was equal to the raw mean score for the placebo group; Alternative hypothesis - The raw mean score for the pregabain group was not equal to the raw mean score for the placebo group.||||0.0006
74085068|NCT00407745|147723817|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.265|<|0.0001|TWO_SIDED|95.0|-1.6|-0.56||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|ANCOVA|ANCOVA model included baseline sleep interference score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.56|-1.60|<0.0001
74085069|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.0295|TWO_SIDED|95.0|-0.94|-0.05||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 1~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.05|-0.94|0.0295
73855946|NCT05312632|147258587|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
73855947|NCT05312632|147258588|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
73855948|NCT05312632|147258589|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
73855949|NCT05312632|147258590|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
73855950|NCT05312632|147258591|OTHER|||||||0.013|||||||Wilcoxon signed rank test|||||||0.013
73855951|NCT05312632|147258592|OTHER|||||||0.053|||||||Wilcoxon signed rank test|||||||0.053
73855952|NCT05312632|147258593|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
73855953|NCT00123162|147258648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|2.9|7.6|||ANCOVA|adjusted for baseline pain intensity (Visual Analog Scale (VAS) score).||With 26 subjects per treatment group and an assumed within-group standard deviation of 7 units, the study was designed to have 90% statistical power for a two-sided, 0.05 significance level test to detect a difference of 6.5 units in TOPAR4 between a single dose of 100 mg of sildenafil and placebo. However, we anticipated subject drop-out as high as 15%; therefore, we planned to recruit 31 subjects per treatment group.||7.6|2.9|<0.001
73855954|NCT00123162|147258649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.6|||<|0.001|TWO_SIDED|95.0|-58.3|-26.8|||Mixed Models Analysis||Comparison of the VAS score at hour 4 (Sildenafil Citrate - Placebo)|||-26.8|-58.3|<.001
73855955|NCT01885208|147258679|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.62|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-0.44|-0.8|< 0.0001
73855956|NCT01885208|147258679|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified superiority margin (0 %).|Treatment difference|-0.62|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-0.44|-0.8|< 0.0001
73855957|NCT01126437|147258692|NON_INFERIORITY_OR_EQUIVALENCE|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.957|||||TWO_SIDED|95.0|0.837|1.094|||Regression, Cox|||H0: Hazard Ratio for Respimat/HandiHaler \>= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler \< 1.25||1.094|0.837|
74085070|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.0033|TWO_SIDED|95.0|-1.11|-0.22||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.22|-1.11|0.0033
74085071|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.23||0.0185|TWO_SIDED|95.0|-0.98|-0.09||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 3~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.09|-0.98|0.0185
73905919|NCT02819518|147342845|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0563|TWO_SIDED|95.0|0.72|1.04||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||1.04|0.72|0.0563
73905920|NCT02819518|147342846|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0093|TWO_SIDED|95.0|0.55|0.95||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.95|0.55|0.0093
73905921|NCT02819518|147342847|SUPERIORITY||Difference in ORR (%) vs. Control|3.8||||0.1413|TWO_SIDED|95.0|-3.2|10.6|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||10.6|-3.2|0.1413
73905922|NCT02819518|147342848|SUPERIORITY||Difference in ORR (%) vs. Control|6.1||||0.0725|TWO_SIDED|95.0|-2.1|14.0|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||14.0|-2.1|0.0725
73905923|NCT02819518|147342849|SUPERIORITY||Difference in ORR(%) vs. Control|12.1||||0.0213|TWO_SIDED|95.0|0.4|23.4|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||23.4|0.4|0.0213
73905924|NCT02819518|147342853|SUPERIORITY||Difference in DCR (%) vs. control|4.7||||0.0966|TWO_SIDED|95.0|-2.4|11.8|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||11.8|-2.4|0.0966
73905925|NCT02819518|147342854|SUPERIORITY||Difference in DCR (%) vs. Control|5.0||||0.1164|TWO_SIDED|95.0|-3.2|13.1|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||13.1|-3.2|0.1164
73905926|NCT02819518|147342855|SUPERIORITY||Difference in DCR (%) vs. Control|10.8||||0.0327|TWO_SIDED|95.0|-0.7|22.3|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||22.3|-0.7|0.0327
73905927|NCT00667602|147342867|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage Difference|-8.0|||||TWO_SIDED|95.0|-15.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥1:8 for serogroup C at 1 month following the 12 months vaccination was greater than -10% .||-1|-15|
73905928|NCT00667602|147342868|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage difference|-7.0|||||TWO_SIDED|95.0|-13.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥ 1:4 for serogroup C at 1 month following the 12 months vaccination was greater than -10%.||-2|-13|
73905929|NCT00667602|147342869|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|72.0|||||TWO_SIDED|95.0|64.0|79.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||79|64|
73905930|NCT00667602|147342869|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Net)|7.0|||||TWO_SIDED|95.0|3.0|13.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||13|3|
73963507|NCT01780298|147462603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.875|||<|0.0001|TWO_SIDED|95.0|0.609|1.141|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||1.141|0.609|<0.0001
73905931|NCT00667602|147342869|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|80.0|||||TWO_SIDED|95.0|73.0|86.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||86|73|
73963508|NCT01780298|147462603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.649|||<|0.0001|TWO_SIDED|95.0|0.386|0.912|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||0.912|0.386|<0.0001
73905932|NCT00667602|147342869|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.0|5.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||5|-2|
73905933|NCT00667602|147342871|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenC \> 0.5).|Ratio|0.92|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA|||For comparison of the Geometric Mean Titers, prevaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||1.12|0.76|
73905934|NCT00667602|147342871|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenC \> 0.5).|Ratio|0.73|||||TWO_SIDED|95.0|0.57|0.93|||ANOVA|||For comparison of the Geometric Mean Titers, one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||0.93|0.57|
73905935|NCT00667602|147342873|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenjugate \> 0.5).|Ratio|10.0|||||TWO_SIDED|95.0|8.43|13.0|||ANOVA|||For comparison of the GMTs (prevaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5 .||13|8.43|
73905936|NCT00667602|147342873|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenjugate \> 0.5).|Ratio|8.1|||||TWO_SIDED|95.0|6.35|10.0|||ANOVA|||For comparison of the GMTs (one month postvaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5.||10|6.35|
73905937|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
73963509|NCT01780298|147462603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.069||||0.3985|TWO_SIDED|95.0|-0.093|0.231|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.231|-0.093|0.3985
73905938|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
73905939|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-3.0|5.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||5|-3|
73905940|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-3|
73963510|NCT01780298|147462603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22||||0.0267|TWO_SIDED|95.0|0.026|0.414|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.414|0.026|0.0267
73963511|NCT01780298|147462603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.305||||0.0036|TWO_SIDED|95.0|0.104|0.506|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.506|0.104|0.0036
74085072|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.1|-0.21||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 4~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.21|-1.10|0.0040
74085073|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.23||0.0004|TWO_SIDED|95.0|-1.26|-0.36||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 5~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.36|-1.26|0.0004
73905941|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
73905942|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, for any of the antigens, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
73905943|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-2.0|||||TWO_SIDED|95.0|-6.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-6|
73905944|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-6|
73905945|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination), given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
73905946|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
73963512|NCT01780298|147462604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.564|||<|0.0001|TWO_SIDED|95.0|1.179|1.949|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1.949|1.179|<0.0001
73963513|NCT01780298|147462604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.291|||<|0.0001|TWO_SIDED|95.0|0.924|1.658|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||1.658|0.924|<0.0001
73963514|NCT01780298|147462604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.073|||<|0.0001|TWO_SIDED|95.0|0.724|1.421|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||1.421|0.724|<0.0001
73963515|NCT01780298|147462604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.276||||0.0282|TWO_SIDED|95.0|0.031|0.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.521|0.031|0.0282
73905947|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-2|
73905948|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-3|
73905949|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 3, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
73905950|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|3.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Polio 3, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-2|
73905951|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
73905952|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
73905953|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
73905954|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-4|
73905955|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
73905956|NCT00667602|147342874|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC)|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-4|
73905957|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-13.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC4, one month postvaccination)given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-13|
73905958|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||TWO_SIDED|95.0|-12.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7(PNC 6B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-1|-12|
74085074|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.23||0.0018|TWO_SIDED|95.0|-1.17|-0.27||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 6~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.27|-1.17|0.0018
73905959|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7(PnC 9V, one month postvaccination) given concomitantly with MenACWY-CRM197 or MenC was considered non-inferior, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than -10%.||2|-11|
73905960|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 14, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
73905961|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||TWO_SIDED|95.0|-19.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7( PNC 18C, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-2|-19|
73905962|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||TWO_SIDED|95.0|-17.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 19F, one month postvaccination), given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-2|-17|
73930933|NCT00280566|147391709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.19||0.0085|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0085
74025484|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|0.71|||||TWO_SIDED|95.0|0.57|0.88||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.57|
74025485|NCT01193335|147604178|SUPERIORITY_OR_OTHER||GMC ratio|0.85|||||TWO_SIDED|95.0|0.68|1.07||||||Serotype 19: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.68|
74025486|NCT01193335|147604187|SUPERIORITY_OR_OTHER|||||||0.668|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.668
74025487|NCT01193335|147604187|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.051
74085075|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0027|TWO_SIDED|95.0|-1.14|-0.24||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 7~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.24|-1.14|0.0027
74025488|NCT01193335|147604188|SUPERIORITY_OR_OTHER|||||||0.704|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.704
74025489|NCT01193335|147604188|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||>0.99
74025490|NCT01193335|147604189|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.531
74085076|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0041|TWO_SIDED|95.0|-1.11|-0.21||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 8~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.21|-1.11|0.0041
74085077|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.23||0.0058|TWO_SIDED|95.0|-1.09|-0.18||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 9~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.18|-1.09|0.0058
73855958|NCT01126437|147258692|NON_INFERIORITY_OR_EQUIVALENCE|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.996|||||TWO_SIDED|95.0|0.872|1.136|||Regression, Cox|||H0: Hazard Ratio for Respimat/HandiHaler \>= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler \< 1.25||1.136|0.872|
73855959|NCT01126437|147258693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.978||||0.4194|TWO_SIDED|95.0|0.928|1.032|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.032|0.928|0.4194
73855960|NCT01126437|147258693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.016||||0.5593|TWO_SIDED|95.0|0.964|1.07|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.070|0.964|0.5593
73855961|NCT01126437|147258693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.038||||0.1639|TWO_SIDED|95.0|0.985|1.094|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.094|0.985|0.1639
73855962|NCT01126437|147258694|NON_INFERIORITY_OR_EQUIVALENCE|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.014|||TWO_SIDED|95.0|-0.038|0.018||An autoregression-1 covariance structure modeled the within-subject errors because visits were equally spaced. The Kenward-Roger approximation estimated denominator degrees of freedom.|Mixed Model Repeated Measures||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler \< 50 ml"||0.018|-.038|
73855963|NCT01126437|147258694|NON_INFERIORITY_OR_EQUIVALENCE|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.037|STANDARD_ERROR_OF_MEAN|0.014|||TWO_SIDED|95.0|-0.065|-0.009||An autoregression-1 covariance structure modeled the within-subject errors because visits were equally spaced. The Kenward-Roger approximation estimated denominator degrees of freedom.|Mixed Model Repeated Measures||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler \< 50 ml"||-.009|-.065|
73855964|NCT01126437|147258695|SUPERIORITY_OR_OTHER||Rate ratio of events|1.01|STANDARD_ERROR_OF_MEAN|0.03||0.833|TWO_SIDED|95.0|0.95|1.06|||Negative binomial regression|||||1.06|0.95|0.8330
73855965|NCT01126437|147258695|SUPERIORITY_OR_OTHER||Rate ratio of events|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.8047|TWO_SIDED|95.0|0.94|1.05|||Negative binomial regression|||||1.05|0.94|0.8047
73930934|NCT00280566|147391709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.18||0.1317|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1317
74025491|NCT01193335|147604189|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||>0.99
74025492|NCT01193335|147604190|SUPERIORITY_OR_OTHER|||||||0.183|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.183
74025493|NCT01193335|147604190|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.357
74025494|NCT01193335|147604191|SUPERIORITY_OR_OTHER|||||||0.794|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.794
74085078|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0031|TWO_SIDED|95.0|-1.14|-0.23||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 10~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.23|-1.14|0.0031
73855966|NCT01126437|147258695|SUPERIORITY_OR_OTHER||Rate ratio of events|1.01|STANDARD_ERROR_OF_MEAN|0.03||0.6468|TWO_SIDED|95.0|0.96|1.07|||Negative binomial regression|||||1.07|0.96|0.6468
73855967|NCT01126437|147258696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.068||||0.1762|TWO_SIDED|95.0|0.971|1.176|||Regression, Cox|||||1.176|0.971|0.1762
73855968|NCT01126437|147258696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024||||0.6384|TWO_SIDED|95.0|0.929|1.128|||Regression, Cox|||||1.128|0.929|0.6384
73855969|NCT01126437|147258696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.044||||0.3784|TWO_SIDED|95.0|0.949|1.148|||Regression, Cox|||||1.148|0.949|0.3784
73855970|NCT01126437|147258697|SUPERIORITY_OR_OTHER||Rate ratio of events|1.09|STANDARD_ERROR_OF_MEAN|0.06||0.1255|TWO_SIDED|95.0|0.98|1.22||p-value from negative binomial regression.|Negative binomial regression|||||1.22|0.98|0.1255
73855971|NCT01126437|147258697|SUPERIORITY_OR_OTHER||Rate ratio of events|1.06|STANDARD_ERROR_OF_MEAN|0.06||0.3441|TWO_SIDED|95.0|0.94|1.18||p-value from negative binomial regression.|Negative binomial regression|||||1.18|0.94|0.3441
73855972|NCT01126437|147258697|SUPERIORITY_OR_OTHER||Rate ratio of events|1.03|STANDARD_ERROR_OF_MEAN|0.06||0.5573|TWO_SIDED|95.0|0.92|1.16||p-value from negative binomial regression.|Negative binomial regression|||||1.16|0.92|0.5573
73855973|NCT01126437|147258698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.011||||0.6823|TWO_SIDED|95.0|0.959|1.066|||Regression, Cox|||||1.066|0.959|0.6823
73855974|NCT01126437|147258698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.983||||0.5377|TWO_SIDED|95.0|0.932|1.037|||Regression, Cox|||||1.037|0.932|0.5377
73855975|NCT01126437|147258698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.028||||0.3048|TWO_SIDED|95.0|0.975|1.084|||Regression, Cox|||||1.084|0.975|0.3048
73855976|NCT01126437|147258699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.105||||0.3043|TWO_SIDED|95.0|0.913|1.336|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.336|0.913|0.3043
73855977|NCT01126437|147258699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.3263|TWO_SIDED|95.0|0.909|1.331|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.331|0.909|0.3263
73855978|NCT01126437|147258699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.004||||0.9644|TWO_SIDED|95.0|0.834|1.209|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.209|0.834|0.9644
73855979|NCT01126437|147258700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.2439|TWO_SIDED|95.0|0.898|1.526|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.526|0.898|0.2439
73855980|NCT01126437|147258700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.4413|TWO_SIDED|95.0|0.85|1.453|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.453|0.850|0.4413
73855981|NCT01126437|147258700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.054||||0.691|TWO_SIDED|95.0|0.814|1.363|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.363|0.814|0.6910
73855982|NCT01220973|147258709|OTHER||Slope|0.74|||||TWO_SIDED|||||||||||||
73855983|NCT01972308|147258710|SUPERIORITY||Group differences in expected 12 month c|-0.31|||||TWO_SIDED|95.0|-0.64|0.04||||||||0.04|-0.64|
73855984|NCT01972308|147258711|SUPERIORITY||Group differences in expected 12 month c|-0.66|||||TWO_SIDED|95.0|-1.38|-0.01||||||||-0.01|-1.38|
73855985|NCT01972308|147258712|SUPERIORITY||Group differences in expected 12 month c|0.06|||||TWO_SIDED|95.0|-0.33|0.43||||||||0.43|-0.33|
73855986|NCT01972308|147258713|SUPERIORITY||Group differences in expected 12 month c|0.02|||||TWO_SIDED|95.0|-0.42|0.48||||||||0.48|-0.42|
73855987|NCT01972308|147258714|SUPERIORITY||Group differences in expected 12 month c|0.04|||||TWO_SIDED|95.0|-0.1|0.19||||||||0.19|-0.10|
73855988|NCT01972308|147258715|SUPERIORITY||Group differences in expected 12 month c|0.12|||||TWO_SIDED|95.0|-0.24|0.6||||||||0.60|-0.24|
73855989|NCT01562314|147258738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.821||||0.7532|TWO_SIDED|90.0|0.292|2.309|||Regression, Logistic|||||2.309|0.292|0.7532
73855990|NCT01562314|147258739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.7032|TWO_SIDED|90.0|0.419|4.04|||Regression, Logistic|||||4.040|0.419|0.7032
73855991|NCT02851797|147258758|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in 4SC at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|generalised least square mean ratio|0.86|||=|0.0345|TWO_SIDED|95.0|0.745|0.989||LS Means, CIs, and p-values are obtained from ANCOVA model on change from baseline in 4SC at Month 18 with baseline values for: the above mentioned parameters as covariates, with steroid use and treatment group as independent classificat factors.|ANCOVA||LS Means, CIs, and p-values are obtained from ANCOVA model on change from baseline in 4SC at Month 18 with baseline values for: the above mentioned parameters as covariates, with steroid use and treatment group as independent classificat factors.|Log transformation applied||0.989|0.745|=0.0345
74025495|NCT01193335|147604191|SUPERIORITY_OR_OTHER|||||||0.782|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.782
74025496|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR Ratio|0.85|||||TWO_SIDED|95.0|0.63|1.14||||||Serotype 4: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.14|0.63|
73905963|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 23F, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||1|-12|
73905964|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-12.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC4, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-12|
74025497|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|1.24|||||TWO_SIDED|95.0|0.95|1.62||||||Serotype 6B: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.62|0.95|
74025498|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|1.19|||||TWO_SIDED|95.0|0.96|1.47||||||Serotype 9V: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.47|0.96|
74025499|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|0.97|||||TWO_SIDED|95.0|0.74|1.26||||||Serotype 14: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.26|0.74|
74025500|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|0.8|||||TWO_SIDED|95.0|0.63|1.02||||||Serotype 18C: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.02|0.63|
74025501|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|0.88|||||TWO_SIDED|95.0|0.65|1.19||||||Serotype 19F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.19|0.65|
74025502|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|1.0|||||TWO_SIDED|95.0|0.74|1.33||||||Serotype 23F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.||1.33|0.74|
74025503|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|0.84|||||TWO_SIDED|95.0|0.64|1.11||||||Serotype 1: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.||1.11|0.64|
74025504|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|1.46|||||TWO_SIDED|95.0|1.03|2.05||||||Serotype 3: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||2.05|1.03|
74025505|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|1.0|||||TWO_SIDED|95.0|0.81|1.24||||||Serotype 5: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.24|0.81|
74085079|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.23||0.0076|TWO_SIDED|95.0|-1.08|-0.17||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 11~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.17|-1.08|0.0076
74025506|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|1.36|||||TWO_SIDED|95.0|1.02|1.82||||||Serotype 6A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.82|1.02|
74025507|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|0.96|||||TWO_SIDED|95.0|0.78|1.18||||||Serotype 7F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.18|0.78|
74025508|NCT01193335|147604192|SUPERIORITY_OR_OTHER||GMFR ratio|1.15|||||TWO_SIDED|95.0|0.88|1.52||||||Serotype 19A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.52|0.88|
74025509|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
74025510|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|-2.33|||||TWO_SIDED|95.0|-8.15|1.96||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||1.96|-8.15|
74025511|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
74025512|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
73855992|NCT02851797|147258759|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in time to rise from the Floor at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 m, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|difference in least square means|-3.28|||=|0.3044|TWO_SIDED|95.0|-9.573|3.018||See comment above|ANCOVA||See comment above|||3.018|-9.573|=0.3044
73855993|NCT02851797|147258760|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in distance walked at the end of the 6-minute walking test (6MWT) at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|9.96|||=|0.3723|TWO_SIDED|95.0|-12.071|31.983||See comment above|ANCOVA|LS means, CIs, p-values were obtained from analysis of covariance model on change from baseline in distance walked at the end of the 6MWT at Month18.|See comment above|||31.983|-12.071|=0.3723
73855994|NCT02851797|147258761|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in total NSAA score at Month 18 with baseline values for: total NSAA score, 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|1.91|||=|0.0209|TWO_SIDED|95.0|0.295|3.533||Same comment as above|ANCOVA||Same comment as above.|||3.533|0.295|=0.0209
73855995|NCT02851797|147258762|SUPERIORITY|Estimated cumulative failures, ratio of cumulative failures, CIs, and p-values are obtained from a negative binomial regression on the subject cumulative number of failures across all post-baseline visits. Total failed items at baseline, baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose were included as independent covariates, with treatment group and steroid use included as indep classification factors.|Ratio of cumulative failures|0.61|||=|0.0202|TWO_SIDED|95.0|0.408|0.927||same comment as above|negative binomial regression model|Estimated cumulative failures, their ratio were obtained from a negative binomial regression on the cumulative N of failures across all visits.|"A lower ratio indicates a greater reduction in cumulative loss of function across 18 months for givinostat compared with placebo.~See also comment above."|||0.927|0.408|=0.0202
73855996|NCT02851797|147258763|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in normalised muscle strength at Month 18 with baseline normalised muscle strength and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|0.19|||=|0.0902|TWO_SIDED|95.0|-0.03|0.401||same comment as above|ANCOVA||same comment as above|Overall knee extension||0.401|-0.030|=0.0902
73855997|NCT02851797|147258763|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in normalised muscle strength at Month 18 with baseline normalised muscle strength and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|0.09|||=|0.1818|TWO_SIDED|95.0|-0.041|0.213||same comment as above|ANCOVA||same comment as above|Overall elbow flexion||0.213|-0.041|=0.1818
73855998|NCT02851797|147258764|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in VL MFF at Month 18 with baseline VL MFF and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|-2.92|||=|0.0354|TWO_SIDED|95.0|-5.641|-0.204||Same comment as above|ANCOVA||Same comment as above|||-0.204|-5.641|=0.0354
73855999|NCT04295681|147258810|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.0006|TWO_SIDED|95.0|0.47|1.7|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of MoCA scores (90th day of treatment minus baseline) were compared.||1.70|0.47|0.0006
73856000|NCT04295681|147258811|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.58|0.37|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of NIHSS scores (baseline minus 12th day of treatment) were compared.||0.37|-0.58|0.67
73856001|NCT04295681|147258811|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.94|TWO_SIDED|95.0|-0.47|0.5|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of NIHSS scores (baseline minus 90th day of treatment) were compared.||0.50|-0.47|0.94
73856002|NCT04295681|147258812|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Test for comparison percentage of patients with no significant disabilities after 90 days of treatment .||||0.89
73856003|NCT04295681|147258813|SUPERIORITY|||||||0.067|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect score comparison on 90th day of treatment.||||0.067
73856004|NCT04295681|147258813|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Side effects score comparison on 90th day of treatment.||||0.81
73856005|NCT04295681|147258813|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Efficacy index score comparison on 90th day of treatment.||||0.17
73856006|NCT04295681|147258814|SUPERIORITY|||||||0.656|||||||Fisher Exact|||The percentage of participants having at least one adverse event were compared.||||0.656
73856007|NCT04295681|147258815|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73963516|NCT01780298|147462604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.207||||0.1223|TWO_SIDED|95.0|-0.057|0.471|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.471|-0.057|0.1223
74025513|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|1.15|||||TWO_SIDED|95.0|-3.13|6.24||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||6.24|-3.13|
73905965|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|0.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC6B, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||0|-11|
73905966|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 9V, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-10|
73905967|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC14, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-4|
73963517|NCT01780298|147462604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.492|||<|0.0001|TWO_SIDED|95.0|0.273|0.71|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.710|0.273|<0.0001
74025514|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
73856008|NCT04295681|147258817|SUPERIORITY|||||||0.96|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.96
73856009|NCT04295681|147258818|SUPERIORITY|||||||0.96|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.96
73856010|NCT04295681|147258819|SUPERIORITY|||||||0.438|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Systolic blood pressure. Analysis of varience (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.438
73856011|NCT04295681|147258819|SUPERIORITY|||||||0.56|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Diastolic blood pressure. Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.56
73856012|NCT04295681|147258820|SUPERIORITY|||||||0.72|||||||Fisher Exact|||Comparison at the baseline.||||0.72
73856013|NCT04295681|147258820|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison on 90th day of treatment.||||1
73856014|NCT04295681|147258821|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73856015|NCT03070223|147258861|SUPERIORITY||Mean Difference (Net)|-0.1||||0.31|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.10|-0.30|0.31
73856016|NCT03070223|147258863|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.62|TWO_SIDED|95.0|-1.72|2.88|||Regression, Linear||Treatment group difference was estimated using baseline-adjusted linear regression model.|Comparison of Month 24 values||2.88|-1.72|0.62
73856017|NCT03070223|147258864|SUPERIORITY||Mean Difference (Net)|-0.001||||0.61|TWO_SIDED|95.0|-0.007|0.004|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.004|-0.007|0.61
73856018|NCT03070223|147258865|SUPERIORITY||Mean Difference (Net)|-0.028||||0.8|TWO_SIDED|95.0|-0.25|0.19|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.19|-0.25|0.80
73856019|NCT03070223|147258866|SUPERIORITY||Risk Ratio (RR)|1.02||||0.33|TWO_SIDED|95.0|0.98|1.06|||Log-binomial regression using GEE|P-value is from the time and treatment group interaction.|Treatment effect is shown as relative annualized risk of impairment in the pitavastatin group compared to placebo (1 reflects no difference between treatment groups).|||1.06|0.98|0.33
73963518|NCT01780298|147462605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.372|||<|0.0001|TWO_SIDED|95.0|0.269|0.478|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||0.478|0.269|<0.0001
73856020|NCT03070223|147258867|SUPERIORITY||Mean Difference (Net)|-0.005||||0.18|TWO_SIDED|95.0|-0.013|0.002|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.002|-0.013|0.18
73856021|NCT03070223|147258868|SUPERIORITY||Risk Ratio (RR)|1.06||||0.47|TWO_SIDED|95.0|0.91|1.24|||Log-binomial regression using GEE|P-value is from the time (before vs. after study treatment initiation) and treatment group interaction.|Treatment effect is shown as relative average risk of impairment over follow-up time in the pitavastatin group compared to placebo (1 reflects no difference between treatment groups).|||1.24|0.91|0.47
73856022|NCT03070223|147258873|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.55|TWO_SIDED|95.0|-2.7|1.4|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||1.4|-2.7|0.55
73856023|NCT03070223|147258874|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.67|TWO_SIDED|95.0|-2.8|1.8|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||1.8|-2.8|0.67
73856024|NCT03070223|147258875|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-0.5|0.52|||Regression, Linear||Treatment group difference (pitavastatin minus placebo) at Month 24 was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.52|-0.50|0.98
73856025|NCT03070223|147258876|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.31|TWO_SIDED|95.0|-0.8|0.3|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.3|-0.8|0.31
73856026|NCT03070223|147258877|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.21|TWO_SIDED|95.0|-0.2|0.9|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.9|-0.2|0.21
73856027|NCT03219034|147258879|SUPERIORITY||Median Difference (Final Values)|3.8||||0.152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Cross-over design: Median differences between oral appliances at the end of the first 4-week leg of the study (T2). The hypothesis tested was that REI would be lowered more with Appliance A than B.||||0.152
73856028|NCT02438683|147258881|OTHER||Slope|0.0029|||||TWO_SIDED|95.0|0.0012|0.0046||||The covariance structure is No diagonal Factor Analytic FA0(2).||The regression model with response variable placebo-corrected HR change from baseline (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject. (Primary analysis).||0.0046|0.0012|
73856029|NCT02438683|147258882|OTHER||Mean Difference (Net)|3.85|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|90.0|0.73|6.97||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||6.97|0.73|
73856030|NCT02438683|147258883|OTHER||Mean Difference (Net)|4.93|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|1.69|8.16||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 200 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||8.16|1.69|
73856031|NCT02438683|147258884|OTHER||Slope|0.0011|||||TWO_SIDED|95.0|-0.0009|0.003||||The covariance structure is No diagonal Factor Analytic FA0(2).||The regression model with response variable placebo-corrected QTcF change from baseline (ddQTcF) and independent variable. Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject (Primary analysis). The covariance structure is No diagonal Factor Analytic FA0(2).||0.0030|-0.0009|
73856032|NCT02438683|147258885|OTHER||Mean Difference (Net)|4.54|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|3.39|5.7||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||5.70|3.39|
73856033|NCT02438683|147258886|OTHER||Mean Difference (Net)|4.73|STANDARD_ERROR_OF_MEAN|1.99|||TWO_SIDED|90.0|1.34|8.13||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 200 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||8.13|1.34|
73856034|NCT02438683|147258887|OTHER||Slope|0.0054|||||TWO_SIDED|95.0|0.0032|0.0076||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected max HR (dHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject. (Primary analysis)||0.0076|0.0032|
73963519|NCT01780298|147462605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.256|||<|0.0001|TWO_SIDED|95.0|0.158|0.354|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||0.354|0.158|<0.0001
73905968|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-15.0|||||TWO_SIDED|95.0|-24.0|-6.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC18C, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-6|-24|
73905969|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-9.0|||||TWO_SIDED|95.0|-17.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC19F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-1|-17|
73905970|NCT00667602|147342875|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||TWO_SIDED|95.0|-13.0|0.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC23F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||0|-13|
73905971|NCT00667602|147342880|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|71.0|||||TWO_SIDED|95.0|63.0|78.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||78|63|
73905972|NCT00667602|147342880|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||TWO_SIDED|95.0|-3.0|6.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||6|-3|
73905973|NCT00667602|147342880|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||TWO_SIDED|95.0|-2.0|7.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||7|-2|
73905974|NCT00667602|147342880|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||1|-11|
73963520|NCT01780298|147462605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.136||||0.0199|TWO_SIDED|95.0|0.022|0.249|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||0.249|0.022|0.0199
73963521|NCT01780298|147462605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.117||||0.0247|TWO_SIDED|95.0|0.015|0.218|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.218|0.015|0.0247
73963522|NCT01780298|147462605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.0204|TWO_SIDED|95.0|0.019|0.221|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.221|0.019|0.0204
73963523|NCT01780298|147462605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.237|||<|0.0001|TWO_SIDED|95.0|0.127|0.347|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.347|0.127|<0.0001
73963524|NCT04425863|147462633|OTHER|||||||0.0246|||||||Chi-squared|||A chi-squared test is used to find out whether there is a statistically significant decrease in mortality rate when the IDEA treatment protocol is used in hospitalized patients in comparison with other treatments in the same hospital in the same period of time (3 out of 12 inpatients died)||||0.0246
73971125|NCT03221426|147482731|OTHER||Hazard Ratio (HR)|0.82||||0.04125|TWO_SIDED|95.0|0.65|1.03||One-sided p-value based on log-rank test with stratification|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification|||1.03|0.65|0.04125
73971126|NCT03221426|147482732|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.04493|TWO_SIDED|95.0|0.71|1.03||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)|||1.03|0.71|0.04493
73905975|NCT00667602|147342880|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|31.0|||||TWO_SIDED|95.0|24.0|39.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||39|24|
73905976|NCT00667602|147342880|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||4|-2|
73905977|NCT00667602|147342880|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|4.0|||||TWO_SIDED|95.0|-3.0|11.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||11|-3|
73905978|NCT00667602|147342880|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-13.0|||||TWO_SIDED|95.0|-22.0|-5.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||-5|-22|
73905979|NCT00667602|147342880|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-10.0|||||TWO_SIDED|95.0|-17.0|-4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||-4|-17|
73905980|NCT00667602|147342880|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||1|-11|
73905981|NCT00667602|147342882|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Ratio|1.33|||||TWO_SIDED|95.0|0.96|1.83|||ANOVA|||For comparison of the Geometric Mean Titers at one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||1.83|0.96|
73905982|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.265|||||TWO_SIDED|95.0|0.998|1.603|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.603|0.998|
73905983|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.999|||||TWO_SIDED|95.0|0.791|1.262|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.262|0.791|
73905984|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||TWO_SIDED|95.0|0.558|0.897|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.897|0.558|
73905985|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.861|||||TWO_SIDED|95.0|0.681|1.089|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.089|0.681|
73905986|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||TWO_SIDED|95.0|0.596|0.956|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.956|0.596|
74025515|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|-1.16|||||TWO_SIDED|95.0|-6.32|3.1||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||3.10|-6.32|
74025516|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
73905987|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.548|||||TWO_SIDED|95.0|0.434|0.693|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.693|0.434|
73905988|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||TWO_SIDED|95.0|0.51|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.817|0.510|
73905989|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.79|||||TWO_SIDED|95.0|0.625|1.0|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.000|0.625|
73905990|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.56|||||TWO_SIDED|95.0|0.441|0.71|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.710|0.441|
73905991|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.681|||||TWO_SIDED|95.0|0.538|0.862|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.862|0.538|
73963525|NCT04425863|147462633|OTHER|||||||0.0475|||||||Chi-squared|||Overall mortality rate of patients treated according to IDEA protocol is compared by a chi-squared test against overall mortality rate in Argentina (the same region where the hospital is located). Data used for overall mortality in Argentina correspond to June 30th according to the website of the Ministry of Health of Argentina||||0.0475
73963526|NCT04425863|147462633|OTHER|||||||0.0025|||||||Chi-squared|||A chi-square test was applied to compare the mortality rate of patients treated with IDEA protocol as compared with data published (26.84 %) in Bertsimas D, Lukin G, Mingardi L, Nohadani O, Orfanoudaki A, Stellato B et al. (2020), COVID-19 Mortality Risk Assessment: An International Multi-Center Study doi: 10.1101/2020.07.07.20148304||||0.0025
73963527|NCT02597920|147462668|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 2.||||<0.0001
73963528|NCT02597920|147462668|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 3.||||<0.0001
73963529|NCT02597920|147462668|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 2.||||<0.0001
73963530|NCT02597920|147462668|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 3.||||<0.0001
73963531|NCT02597920|147462669|OTHER|||||||0.0005|||||||Propensity score matching method|||Between group comparison of Visit 2 CDS||||0.0005
74025517|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|-8.72|||||TWO_SIDED|95.0|-21.93|4.42||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.42|-21.93|
73905992|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.597|||||TWO_SIDED|95.0|0.47|0.757|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.757|0.470|
73963532|NCT02597920|147462669|OTHER|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 3 CDS||||0.0002
73963533|NCT02597920|147462669|OTHER|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 2 SDS||||0.0002
73963534|NCT02597920|147462669|OTHER|||||||0.0004|||||||Propensity score matching method|||Between group comparison of Visit 3 SDS||||0.0004
73963535|NCT02597920|147462674|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 CDS with that of Visit 3.||||<0.0001
73963536|NCT02597920|147462674|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 SDS with that of Visit 3.||||<0.0001
73963537|NCT04040296|147462684|SUPERIORITY||Difference in percentage|1.4||||0.28|TWO_SIDED|95.0|-1.1|3.8|||Cochran-Mantel-Haenszel||Difference between arms in the percentage of subjects with the primary outcome within 14 days of randomization.|||3.8|-1.1|0.28
73963538|NCT04040296|147462685|SUPERIORITY||Difference in percentage|9.5|||<|0.001|TWO_SIDED|95.0|8.1|11.0|||Van Elteren test||Difference between arms in the percentage of implemented recommendations with 24 hours of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||11|8.1|<.001
73963539|NCT04040296|147462686|SUPERIORITY||Difference in percentage|0.5||||0.65|TWO_SIDED|95.0|-1.6|2.6|||Van Elteren test||Difference between arms in the percentage of subjects with AKI progression within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||2.6|-1.6|.65
73963540|NCT04040296|147462687|SUPERIORITY||Difference in percentage|0.1||||0.89|TWO_SIDED|95.0|-0.7|0.8|||Van Elteren test||Difference between arms in the percentage of subjects who received inpatient dialysis within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||.8|-.7|.89
73963541|NCT04040296|147462688|SUPERIORITY||Difference in percentage|0.4||||0.72|TWO_SIDED|95.0|-1.5|2.1|||Van Elteren test||Difference between arms in the percentage of subjects with inpatient mortality within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||2.1|-1.5|.72
73905993|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.434|||||TWO_SIDED|95.0|0.342|0.549|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.549|0.342|
73905994|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.511|||||TWO_SIDED|95.0|0.403|0.647|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.647|0.403|
73905995|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||TWO_SIDED|95.0|0.56|0.896|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.896|0.560|
73963542|NCT04040296|147462689|SUPERIORITY||Difference in percentage|1.9||||0.31|TWO_SIDED|95.0|-0.3|4.1|||Van Elteren test||Difference between arms in the percentage of subjects who received a kidney consult within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||4.1|-.3|.31
73963543|NCT04040296|147462690|SUPERIORITY||Difference in percentage|-0.9||||0.17|TWO_SIDED|95.0|-2.3|0.4|||Van Elteren test||Difference between arms in the percentage of subjects discharged to hospice care within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||.4|-2.3|.17
73963544|NCT05489484|147462691|OTHER|Paired-sample t-test was used to assess the change in Constant-Murley Score from baseline to 3 months.|Mean Difference (Net)|10.03|STANDARD_ERROR_OF_MEAN|2.124||0.001|TWO_SIDED|95.0|3.63|16.0|||t-test, 2 sided||Mean change from baseline in CMS at 3 months. Higher scores represent better shoulder function. Positive difference indicates clinical improvement.|Statistical analysis was performed on 23 participants with valid Constant-Murley Score (CMS) data at both baseline and 3-month follow-up.||16.00|3.63|0.001
73963545|NCT00444600|147462703|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-55.0|||<|0.001|TWO_SIDED|95.0|-78.0|-32.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in central subfield thickness mean change from sham+prompt laser||-32|-78|<0.001
73963546|NCT00444600|147462703|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-49.0|||<|0.001|TWO_SIDED|95.0|-72.0|-26.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser||-26|-72|<0.001
73963547|NCT00444600|147462703|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-52.0|||<|0.001|TWO_SIDED|95.0|-75.0|-29.0||Confidence interval is adjusted for multiple comparisons|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser||-29|-75|<0.001
73963548|NCT00444600|147462705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.2|8.5||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||8.5|3.2|<0.001
73963549|NCT00444600|147462705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0|||<|0.001|TWO_SIDED|95.0|3.4|8.6||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||8.6|3.4|<0.001
73963550|NCT00444600|147462705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.31|TWO_SIDED|95.0|-1.5|3.7||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||3.7|-1.5|0.31
73905996|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.862|||||TWO_SIDED|95.0|0.683|1.088|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.088|0.683|
73905997|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.755|||||TWO_SIDED|95.0|0.597|0.954|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.954|0.597|
73905998|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.549|||||TWO_SIDED|95.0|0.435|0.692|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.692|0.435|
74025518|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
73905999|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||TWO_SIDED|95.0|0.511|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.817|0.511|
73963551|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|23.0|||||TWO_SIDED|95.0|13.0|34.0||Confidence intervals are adjusted for multiple comparisons.|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement for sham+prompt laser at 1 year||34|13|
73963552|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|19.0|||||TWO_SIDED|95.0|9.0|29.0||Confidence intervals adjusted for multiple comparisons|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year||29|9|
73963553|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|6.0|||||TWO_SIDED|95.0|-4.0|16.0||Confidence intervals adjusted for multiple comparisons|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year||16|-4|
73906000|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.217|||||TWO_SIDED|95.0|0.961|1.541|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.541|0.961|
73906001|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.066|||||TWO_SIDED|95.0|0.841|1.352|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.352|0.841|
73856035|NCT02438683|147258888|OTHER||Slope|-0.0014|||||TWO_SIDED|95.0|-0.0036|0.0008||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected change from max HR to recovery HR (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept estimates for each subject (Primary analysis).||0.0008|-0.0036|
73856036|NCT02438683|147258888|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.0029|||||TWO_SIDED|95.0|-0.0052|-0.0007||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected change from max HR to recovery HR (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept estimates for each subject (Primary analysis).||-0.0007|-0.0052|
73856037|NCT03315793|147258889|SUPERIORITY||Least squares mean difference|1.39||||0.5587|TWO_SIDED|98.0|-3.3|6.08|||mixed-effects model repeated measures|||||6.08|-3.30|0.5587
73856038|NCT03315793|147258890|SUPERIORITY||Risk Difference (RD)|5.4||||0.5111|TWO_SIDED|95.0|-10.7|21.5|||Cochran-Mantel-Haenszel|Stratified by age||||21.5|-10.7|0.5111
73856039|NCT03315793|147258891|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-13.5|13.5|||Cochran-Mantel-Haenszel|Stratified by age||||13.5|-13.5|1.0000
73856040|NCT03315793|147258892|SUPERIORITY||Risk Difference (RD)|-4.1||||0.4423|TWO_SIDED|95.0|-14.4|6.3|||Cochran-Mantel-Haenszel|Stratified by age||||6.3|-14.4|0.4423
73856041|NCT03315793|147258893|SUPERIORITY||Least squares mean difference|0.14||||0.3836|TWO_SIDED|95.0|-0.18|0.46|||mixed-effects model repeated measures|||||0.46|-0.18|0.3836
73856042|NCT01559259|147258978|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean difference|26.28|||<|0.001|TWO_SIDED|95.0|20.33|32.22|||ANOVA|||Treatment difference and 95 percent (%) Confidence interval (CI) were based on Least square mean (LSM) from analysis of variance (ANOVA) with treatment, baseline categorical pain severity rating (PSR), gender and treatment-by-baseline categorical PSR terms used as covariates.||32.22|20.33|<0.001
73856043|NCT01559259|147258978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|24.37|||<|0.001|TWO_SIDED|95.0|18.44|30.29|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||30.29|18.44|<0.001
73856044|NCT01559259|147258978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.48|||<|0.001|TWO_SIDED|95.0|21.53|33.42|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||33.42|21.53|<0.001
73856045|NCT01559259|147258978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|24.85|||<|0.001|TWO_SIDED|95.0|18.93|30.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||30.78|18.93|<0.001
73856046|NCT01559259|147258978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.42||||0.501|TWO_SIDED|95.0|-2.73|5.58|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.58|-2.73|0.501
74025519|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
74025520|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
74025521|NCT01193335|147604194|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
74025522|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||0.97|0.60|
74025523|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.51|||||TWO_SIDED|95.0|0.39|0.66||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.66|0.39|
74025524|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.64|||||TWO_SIDED|95.0|0.51|0.8||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.80|0.51|
74025525|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||1.12|0.66|
74025526|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||1.32|0.85|
73906002|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.775|||||TWO_SIDED|95.0|0.612|0.981|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.981|0.612|
73906003|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.912|||||TWO_SIDED|95.0|0.719|1.157|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.157|0.719|
73906004|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.876|||||TWO_SIDED|95.0|0.692|1.109|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.109|0.692|
73906005|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.637|||||TWO_SIDED|95.0|0.504|0.804|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.804|0.504|
73906006|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.75|||||TWO_SIDED|95.0|0.593|0.949|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.949|0.593|
73906007|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.727|||||TWO_SIDED|95.0|0.574|0.919|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.919|0.574|
73906008|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.856|||||TWO_SIDED|95.0|0.675|1.084|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.084|0.675|
73906009|NCT00973349|147342908|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.178|||||TWO_SIDED|95.0|0.931|1.489|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.489|0.931|
73906010|NCT02301988|147342917|SUPERIORITY||Difference in Response Rates|3.77||||0.519||95.0|-8.99|16.54|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis||16.54|-8.99|0.519
73906011|NCT02301988|147342918|SUPERIORITY||Difference in response rates|3.29||||0.7817|TWO_SIDED|95.0|-25.52|32.1|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||32.10|-25.52|0.7817
73906012|NCT02301988|147342919|SUPERIORITY||Difference in Response Rates|7.7||||0.2234|TWO_SIDED|95.0|-5.95|21.35|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||21.35|-5.95|0.2234
73906013|NCT02301988|147342920|SUPERIORITY||Difference in response rates|-2.96||||0.8169|TWO_SIDED|95.0|-33.91|27.99|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||27.99|-33.91|0.8169
74025527|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.58|0.92||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||0.92|0.58|
73906014|NCT02301988|147342921|SUPERIORITY||Difference in response rate|11.11||||0.1607||95.0|-5.64|27.85|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||27.85|-5.64|0.1607
73906015|NCT02301988|147342922|SUPERIORITY||Difference in Response Rates|23.68||||0.1486|TWO_SIDED|95.0|-13.57|60.94|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis||60.94|-13.57|0.1486
73906016|NCT02301988|147342923|SUPERIORITY||Difference in Response Rates|6.09||||0.498|TWO_SIDED|95.0|-15.01|27.2|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||27.20|-15.01|0.4980
73906017|NCT02301988|147342924|SUPERIORITY||Difference in Response Rates|9.66||||0.3032||95.0|-12.25|31.58|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||31.58|-12.25|0.3032
73906018|NCT02301988|147342926|SUPERIORITY||Difference in Response Rates|4.2||||0.628|TWO_SIDED|95.0|-14.37|22.76|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||22.76|-14.37|0.6280
74025528|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.43|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.43|
74025529|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.77|1.2||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.20|0.77|
74025530|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.41|0.87||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.41|
73906019|NCT02301988|147342927|SUPERIORITY||Difference in Response Rates|8.33||||0.6291|TWO_SIDED|95.0|-33.04|49.71|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||49.71|-33.04|0.6291
73906020|NCT05169567|147342931|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.57|0.95|||Log Rank|||||0.95|0.57|0.02
73906021|NCT01015131|147342935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1521|||<|0.01|TWO_SIDED|90.0|0.0932|0.2111|||paired t-test|||||0.2111|0.0932|<0.01
73906022|NCT05098938|147343017|SUPERIORITY|||||||0.716|||||||Log Rank|||||||0.716
73906023|NCT05098938|147343018|SUPERIORITY|||||||0.102|||||||Chi-squared|||||||0.102
73906024|NCT05098938|147343019|SUPERIORITY|||||||0.712|||||||Chi-squared|||||||0.712
73906025|NCT05098938|147343020|SUPERIORITY|||||||0.575|||||||Log Rank|||||||0.575
73906026|NCT01828320|147343023|SUPERIORITY||d (effect size)|-0.08||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.34
73906027|NCT01828320|147343024|SUPERIORITY||d (effect size)|-0.06||||0.93|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.93
73906028|NCT01828320|147343025|SUPERIORITY||d (effect size)|-0.5||||0.01|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.01
73906029|NCT01828320|147343026|SUPERIORITY||d (effect size)|0.18||||0.17|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.17
73906030|NCT01828320|147343027|SUPERIORITY||d (effect size)|0.07||||0.31|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.31
73906031|NCT01828320|147343028|SUPERIORITY||d (effect size)|0.001||||0.8|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.80
73906032|NCT01828320|147343029|SUPERIORITY||d (effect size)|0.04||||0.96|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.96
73906033|NCT01828320|147343030|SUPERIORITY||d (effect size)|-0.05||||0.83|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.83
73906034|NCT01828320|147343031|SUPERIORITY||d (effect size)|0.35||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
73906035|NCT01828320|147343032|SUPERIORITY||d (effect size)|0.28||||0.04|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.04
73906036|NCT01828320|147343033|SUPERIORITY||d (effect size)|0.29||||0.04|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.04
73906037|NCT01828320|147343034|SUPERIORITY||d (effect size)|-0.44||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.03
73906038|NCT01828320|147343035|SUPERIORITY||d (effect size)|0.07||||0.71|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.71
73906039|NCT01828320|147343036|SUPERIORITY||d (effect size)|0.02||||0.83|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.83
73906040|NCT01828320|147343037|SUPERIORITY||d (effect size)|-0.11||||0.85|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.85
73906041|NCT01828320|147343038|SUPERIORITY||d (effect size)|-0.55||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
73906042|NCT01828320|147343039|SUPERIORITY||d (effect size)|-0.33||||0.05|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.05
73906043|NCT01828320|147343040|SUPERIORITY||d (effect size)|0.04||||0.88|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.88
73906044|NCT01828320|147343041|SUPERIORITY||d (effect size)|0.04||||0.97|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.97
73906045|NCT01828320|147343042|SUPERIORITY||d (effect size)|0.01||||0.88|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: Alone"||||0.88
73906046|NCT01828320|147343042|SUPERIORITY||d (effect size)|-0.18||||0.43|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a family member"||||0.43
73906047|NCT01828320|147343042|SUPERIORITY||d (effect size)|0.21||||0.37|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a peer"||||0.37
73906048|NCT01828320|147343043|SUPERIORITY||d (effect size)|0.29||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
73906049|NCT01828320|147343044|SUPERIORITY||d (effect size)|0.07||||0.49|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.49
73906050|NCT01828320|147343045|SUPERIORITY||d (effect size)|0.11||||0.6|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.60
73906051|NCT01828320|147343046|SUPERIORITY||d (effect size)|0.08||||0.42|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.42
73906052|NCT01828320|147343047|SUPERIORITY||d (effect size)|0.4||||0.01|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.01
73906053|NCT01859143|147343107|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence criterion for fever within 7 days of vaccination mentioned that the upper limit of 95 percent (%) confidence interval (CI) for difference in percentage of participants with fever \>=101 degrees F should be less than 5 percentage points.|Percent difference|0.4|||||TWO_SIDED|95.0|-5.3|2.6|||||A two-sided 95% CI was constructed using the exact method based on the score statistic proposed by Chan and Zhang.|||2.6|-5.3|
73906054|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|11.9|||||TWO_SIDED|95.0|-1.9|23.9|||||Any symptom within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||23.9|-1.9|
73906055|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|0.8|||||TWO_SIDED|95.0|-4.9|3.3|||||Fever \>100 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.3|-4.9|
73906056|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>102 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
73906057|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>103 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
73906058|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|8.9|||||TWO_SIDED|95.0|-2.6|17.7|||||Runny nose within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||17.7|-2.6|
73906059|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|6.2|||||TWO_SIDED|95.0|-2.2|11.6|||||Sore throat within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.6|-2.2|
74025531|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.7|||||TWO_SIDED|95.0|0.56|0.88||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.56|
73906060|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|-0.5|||||TWO_SIDED|95.0|-9.3|4.7|||||Cough within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.7|-9.3|
73906061|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Vomiting within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
74025532|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.41|0.7||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.70|0.41|
73906062|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|-0.1|||||TWO_SIDED|95.0|-8.0|4.3|||||Muscle aches within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.3|-8.0|
73906063|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|1.7|||||TWO_SIDED|95.0|-4.1|4.4|||||Chills within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.4|-4.1|
73906064|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|3.2|||||TWO_SIDED|95.0|-6.5|9.8|||||Decreased activity (tiredness) within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||9.8|-6.5|
73906065|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|3.5|||||TWO_SIDED|95.0|-7.8|11.9|||||Headache within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.9|-7.8|
74025533|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.71|1.03||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.71|
74025534|NCT01193335|147604196|SUPERIORITY_OR_OTHER||GMC Ratio|0.55|||||TWO_SIDED|95.0|0.42|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.42|
74025535|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.65|||||TWO_SIDED|95.0|0.51|0.82||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.51|
74025536|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.47|0.79||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.79|0.47|
74085080|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0328|TWO_SIDED|95.0|-0.95|-0.04||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 12~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.04|-0.95|0.0328
73906066|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|12.3|||||TWO_SIDED|95.0|-1.6|24.4|||||Any symptom within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||24.4|-1.6|
73906067|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|1.2|||||TWO_SIDED|95.0|-4.5|3.9|||||Fever \>100 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.9|-4.5|
73906068|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|0.8|||||TWO_SIDED|95.0|-4.9|3.3|||||Fever \>=101 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.3|-4.9|
73906069|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>102 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
73906070|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>103 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
73906071|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|9.7|||||TWO_SIDED|95.0|-1.8|18.6|||||Runny nose within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||18.6|-1.8|
74025537|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.61|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.93|0.61|
74025538|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.07||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.66|
74025539|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.08||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.08|0.66|
73906072|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|4.4|||||TWO_SIDED|95.0|-5.3|11.2|||||Sore throat within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.2|-5.3|
73906073|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|0.3|||||TWO_SIDED|95.0|-8.6|5.7|||||Cough within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||5.7|-8.6|
74025540|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.48|0.83||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.48|
74025541|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.46|0.79||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.79|0.46|
73906074|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|0.4|||||TWO_SIDED|95.0|-5.3|2.6|||||Vomiting within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||2.6|-5.3|
73906075|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|0.3|||||TWO_SIDED|95.0|-7.8|4.8|||||Muscle aches within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.8|-7.8|
73906076|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|2.5|||||TWO_SIDED|95.0|-3.3|5.5|||||Chills within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||5.5|-3.3|
73906077|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|4.4|||||TWO_SIDED|95.0|-5.3|11.2|||||Decreased activity (tiredness) within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.2|-5.3|
73856047|NCT01559259|147258978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.49||||0.817|TWO_SIDED|95.0|-4.61|3.64|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.64|-4.61|0.817
73856048|NCT01559259|147258978|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.62||||0.216|TWO_SIDED|95.0|-1.53|6.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.78|-1.53|0.216
73856049|NCT01559259|147258979|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|12.69|||<|0.001|TWO_SIDED|95.0|5.52|29.19|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||29.19|5.52|<0.001
73856050|NCT01559259|147258979|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|10.02|||<|0.001|TWO_SIDED|95.0|4.36|23.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||23.02|4.36|<0.001
73856051|NCT01559259|147258979|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|11.66|||<|0.001|TWO_SIDED|95.0|5.07|26.83|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||26.83|5.07|<0.001
73856052|NCT01559259|147258979|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.6|||<|0.001|TWO_SIDED|95.0|3.74|19.77|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||19.77|3.74|<0.001
73856053|NCT01559259|147258979|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.48||||0.014|TWO_SIDED|95.0|1.08|2.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||2.02|1.08|0.014
73856054|NCT01559259|147258979|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.332|TWO_SIDED|95.0|0.86|1.59|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||1.59|0.86|0.332
73856055|NCT01559259|147258979|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.36||||0.056|TWO_SIDED|95.0|0.99|1.85|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||1.85|0.99|0.056
73856056|NCT01559259|147258980|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|12.1|||<|0.001|TWO_SIDED|95.0|5.24|27.91|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||27.91|5.24|<0.001
73856057|NCT01559259|147258980|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.88|||<|0.001|TWO_SIDED|95.0|3.86|20.44|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||20.44|3.86|<0.001
73856058|NCT01559259|147258980|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|11.47|||<|0.001|TWO_SIDED|95.0|4.98|26.42|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||26.42|4.98|<0.001
73856059|NCT01559259|147258980|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.11|||<|0.001|TWO_SIDED|95.0|3.52|18.68|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||18.68|3.52|<0.001
73856060|NCT01559259|147258980|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.49||||0.012|TWO_SIDED|95.0|1.09|2.04|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||2.04|1.09|0.012
73856061|NCT01559259|147258980|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.57|TWO_SIDED|95.0|0.8|1.49|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||1.49|0.80|0.570
74085081|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.015|TWO_SIDED|95.0|-1.02|-0.11||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 13~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.11|-1.02|0.0150
73856062|NCT01559259|147258980|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.41||||0.03|TWO_SIDED|95.0|1.03|1.93|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||1.93|1.03|0.030
73856063|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.014|TWO_SIDED|95.0|0.08|0.71|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.71|0.08|0.014
73856064|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.038|TWO_SIDED|95.0|0.02|0.64|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.64|0.02|0.038
73856065|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.48||||0.003|TWO_SIDED|95.0|0.17|0.79|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.17|0.003
73906078|NCT01859143|147343108|SUPERIORITY_OR_OTHER||Percent difference|3.0|||||TWO_SIDED|95.0|-8.7|12.0|||||Headache within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||12.0|-8.7|
73906079|NCT00277446|147343183|SUPERIORITY_OR_OTHER||||||<|0.03||95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||<0.03
73906080|NCT00277446|147343184|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||0.02
73906081|NCT00277446|147343185|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||0.88
73906082|NCT00857415|147343205|SUPERIORITY_OR_OTHER||Correlation coefficient|0.78|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|0.58|0.89||A one-sided test (rho \> 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Correlation test||Asymptotic standard error and 95 percent CI used Fisher z-transformation.|Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.||0.89|0.58|<0.0001
73906083|NCT00857415|147343206|SUPERIORITY_OR_OTHER||Specificity|100.0|||||TWO_SIDED|95.0|91.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 3 blinded readers||100|91|
73906084|NCT04231318|147343224|SUPERIORITY|||||||0.0406|||||||ANOVA|||||||0.0406
73906085|NCT04231318|147343224|SUPERIORITY|||||||0.0795|||||||ANOVA|||||||0.0795
73906086|NCT04231318|147343224|SUPERIORITY|||||||0.7601|||||||ANOVA|||||||0.7601
73906087|NCT04231318|147343225|SUPERIORITY|||||||0.1942|||||||ANOVA|||||||0.1942
73906088|NCT04231318|147343225|SUPERIORITY|||||||0.0957|||||||ANOVA|||||||0.0957
73906089|NCT04231318|147343225|SUPERIORITY|||||||0.4526|||||||ANOVA|||||||0.4526
73963554|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.84|||<|0.001|TWO_SIDED|95.0|1.4|2.42||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||2.42|1.40|<0.001
73906090|NCT04231318|147343226|SUPERIORITY|||||||0.1309|||||||ANOVA|||||||0.1309
73906091|NCT04231318|147343226|SUPERIORITY|||||||0.17|||||||ANOVA|||||||0.1700
73906092|NCT04231318|147343226|SUPERIORITY|||||||0.7609|||||||ANOVA|||||||0.7609
73906093|NCT04231318|147343227|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.1000
73906094|NCT04231318|147343227|SUPERIORITY|||||||0.0423|||||||ANOVA|||||||0.0423
73906095|NCT04231318|147343227|SUPERIORITY|||||||0.383|||||||ANOVA|||||||0.3830
73906096|NCT04231318|147343228|SUPERIORITY|||||||0.0298|||||||ANOVA|||||||0.0298
73906097|NCT04231318|147343228|SUPERIORITY|||||||0.0217|||||||ANOVA|||||||0.0217
73906098|NCT04231318|147343228|SUPERIORITY|||||||0.4451|||||||ANOVA|||||||0.4451
73906099|NCT04231318|147343229|SUPERIORITY|||||||0.1197|||||||ANOVA|||||||0.1197
73906100|NCT04231318|147343229|SUPERIORITY|||||||0.0008|||||||ANOVA|||||||0.0008
73906101|NCT04231318|147343229|SUPERIORITY|||||||0.0223|||||||ANOVA|||||||0.0223
73906102|NCT04231318|147343230|SUPERIORITY|||||||0.1067|||||||ANOVA|||||||0.1067
73906103|NCT04231318|147343231|SUPERIORITY|||||||0.1715|||||||ANOVA|||||||0.1715
73906104|NCT04231318|147343231|SUPERIORITY|||||||0.0736|||||||ANOVA|||||||0.0736
73906105|NCT04231318|147343231|SUPERIORITY|||||||0.4098|||||||ANOVA|||||||0.4098
73906106|NCT04231318|147343232|SUPERIORITY|||||||0.2718|||||||ANOVA|||||||0.2718
73906107|NCT04231318|147343232|SUPERIORITY|||||||0.0182|||||||ANOVA|||||||0.0182
73906108|NCT04231318|147343232|SUPERIORITY|||||||0.1131|||||||ANOVA|||||||0.1131
73906109|NCT04231318|147343233|SUPERIORITY|||||||0.2143|||||||ANOVA|||||||0.2143
73906110|NCT04231318|147343233|SUPERIORITY|||||||0.1628|||||||ANOVA|||||||0.1628
73906111|NCT04231318|147343233|SUPERIORITY|||||||0.6036|||||||ANOVA|||||||0.6036
73906112|NCT04231318|147343234|SUPERIORITY|||||||0.222|||||||ANOVA|||||||0.2220
73906113|NCT04231318|147343234|SUPERIORITY|||||||0.141|||||||ANOVA|||||||0.1410
73906114|NCT04231318|147343234|SUPERIORITY|||||||0.5418|||||||ANOVA|||||||0.5418
73906115|NCT04231318|147343235|SUPERIORITY|||||||0.1619|||||||ANOVA|||||||0.1619
73906116|NCT04231318|147343235|SUPERIORITY|||||||0.1683|||||||ANOVA|||||||0.1683
73906117|NCT04231318|147343235|SUPERIORITY|||||||0.6969|||||||ANOVA|||||||0.6969
73906118|NCT04231318|147343236|SUPERIORITY|||||||0.0701|||||||ANOVA|||||||0.0701
73906119|NCT04231318|147343236|SUPERIORITY|||||||0.0925|||||||ANOVA|||||||0.0925
73906120|NCT04231318|147343236|SUPERIORITY|||||||0.6981|||||||ANOVA|||||||0.6981
73906121|NCT04231318|147343237|SUPERIORITY|||||||0.0275|||||||ANOVA|||||||0.0275
73906122|NCT04231318|147343237|SUPERIORITY|||||||0.1738|||||||ANOVA|||||||0.1738
73906123|NCT04231318|147343237|SUPERIORITY|||||||0.8364|||||||ANOVA|||||||0.8364
73906124|NCT04231318|147343238|SUPERIORITY|||||||0.2227|||||||ANOVA|||||||0.2227
73906125|NCT04231318|147343238|SUPERIORITY|||||||0.1114|||||||ANOVA|||||||0.1114
73906126|NCT04231318|147343238|SUPERIORITY|||||||0.4635|||||||ANOVA|||||||0.4635
73906127|NCT00337350|147343239|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANCOVA|||||||0.08
73906128|NCT00337350|147343240|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||||||.05
73906129|NCT00337350|147343241|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|||||||0.21
73906130|NCT03911154|147343249|OTHER|We used linear mixed effect models (in SAS version 9.4, SAS Institute, Cary, NC) with random subject intercept to account for the clustered nature of the data. The model included factors for stimulus modality (4 levels), sleep restriction night (4 levels), and their interaction.|Mean Difference (Net)|0.329|STANDARD_ERROR_OF_MEAN|0.353||0.36|TWO_SIDED|95.0|-0.403|1.06|||Mixed Models Analysis|||Number of lapses of attention were averaged across assessments within each day and the statistical analysis adjusted for baseline.||1.060|-0.403|0.36
73906131|NCT03911154|147343249|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.307|STANDARD_ERROR_OF_MEAN|0.441||0.49|TWO_SIDED|95.0|-1.222|0.608|||Mixed Models Analysis|||Number of lapses of attention upon emergent awakening||0.608|-1.222|0.49
73856066|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.155|TWO_SIDED|95.0|-0.09|0.54|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.09|0.155
73856067|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.135|TWO_SIDED|95.0|-0.05|0.39|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.05|0.135
73856068|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.35|TWO_SIDED|95.0|-0.11|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-0.11|0.350
73856069|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.024|TWO_SIDED|95.0|0.03|0.47|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|0.03|0.024
73856070|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.33|||<|0.001|TWO_SIDED|95.0|0.9|1.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.77|0.90|<0.001
73856071|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.26|||<|0.001|TWO_SIDED|95.0|0.83|1.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|0.83|<0.001
73856072|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35||||0.001|TWO_SIDED|95.0|0.91|1.78|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|0.91|0.001
73856073|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.87|||<|0.001|TWO_SIDED|95.0|0.43|1.3|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|0.43|<0.001
73856074|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.003|TWO_SIDED|95.0|0.16|0.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.77|0.16|0.003
73856075|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.4||||0.01|TWO_SIDED|95.0|0.1|0.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.70|0.10|0.010
73856076|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.48||||0.002|TWO_SIDED|95.0|0.18|0.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.18|0.002
73856077|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.12|||<|0.001|TWO_SIDED|95.0|1.66|2.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.66|<0.001
73856078|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.96|||<|0.001|TWO_SIDED|95.0|1.5|2.42|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.42|1.50|<0.001
73856079|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.14|||<|0.001|TWO_SIDED|95.0|1.67|2.6|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.60|1.67|<0.001
73856080|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.74|||<|0.001|TWO_SIDED|95.0|1.28|2.2|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.20|1.28|<0.001
73856081|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.022|TWO_SIDED|95.0|0.05|0.7|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.70|0.05|0.022
73856082|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.181|TWO_SIDED|95.0|-0.1|0.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.10|0.181
73856083|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.4||||0.016|TWO_SIDED|95.0|0.07|0.72|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|0.07|0.016
73856084|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.43|||<|0.001|TWO_SIDED|95.0|1.98|2.88|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.88|1.98|<0.001
73906132|NCT03911154|147343250|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|0.455|STANDARD_ERROR_OF_MEAN|2.797||0.87|TWO_SIDED|95.0|-5.4|6.31|||Mixed Models Analysis|||||6.310|-5.400|0.87
73906133|NCT03911154|147343251|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.112|STANDARD_ERROR_OF_MEAN|0.798||0.89|TWO_SIDED|95.0|-1.767|1.543|||Mixed Models Analysis|||Number correct on the DSST was averaged across DSST administrations within each day and was adjusted for baseline performance.||1.543|-1.767|0.89
73906134|NCT03911154|147343252|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.381||0.76|TWO_SIDED|95.0|-0.919|0.678|||Mixed Models Analysis|||Number correct on the DST was averaged across DST administrations within each day and adjusted for baseline.||0.678|-0.919|0.76
73906135|NCT03911154|147343253|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|0.085|STANDARD_ERROR_OF_MEAN|0.179||0.64|TWO_SIDED|95.0|-0.286|0.456|||Mixed Models Analysis|||The mean weighted score on the ROBoT was adjusted for baseline.||0.456|-0.286|0.64
73963555|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.68|||<|0.001|TWO_SIDED|95.0|1.27|2.21||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||2.21|1.27|<0.001
73856085|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.72|2.62|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.62|1.72|<0.001
73856086|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.46|||<|0.001|TWO_SIDED|95.0|2.01|2.91|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.91|2.01|<0.001
73856087|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.13|||<|0.001|TWO_SIDED|95.0|1.68|2.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.68|<0.001
73856088|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.3||||0.065|TWO_SIDED|95.0|-0.02|0.61|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.61|-0.02|0.065
73856089|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.817|TWO_SIDED|95.0|-0.28|0.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.28|0.817
73856090|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.043|TWO_SIDED|95.0|0.01|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.64|0.01|0.043
73856091|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.53|||<|0.001|TWO_SIDED|95.0|2.06|3.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.01|2.06|<0.001
73856092|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.34|||<|0.001|TWO_SIDED|95.0|1.87|2.82|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.82|1.87|<0.001
73856093|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.63|||<|0.001|TWO_SIDED|95.0|2.15|3.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.11|2.15|<0.001
73856094|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.36|||<|0.001|TWO_SIDED|95.0|1.89|2.84|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.84|1.89|<0.001
73856095|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.312|TWO_SIDED|95.0|-0.16|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.51|-0.16|0.312
73906136|NCT01209923|147343254|OTHER|||||||0.001|||||||t-test, 2 sided|Independent t-test||Children BIA was compared to hydrostatic weighing; adults were compared to DEXA.||||0.001
73856096|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.02||||0.91|TWO_SIDED|95.0|-0.35|0.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.35|0.910
73856097|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.113|TWO_SIDED|95.0|-0.06|0.6|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.60|-0.06|0.113
73856098|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.48|||<|0.001|TWO_SIDED|95.0|1.98|2.97|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.97|1.98|<0.001
73856099|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.25|||<|0.001|TWO_SIDED|95.0|1.76|2.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.75|1.76|<0.001
73856100|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.51|||<|0.001|TWO_SIDED|95.0|2.02|3.01|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.01|2.02|<0.001
74025542|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.64|1.03||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.64|
74025543|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.73|1.15||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.73|
74025544|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.58|
74025545|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.9||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.57|
74025546|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.0||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.00|0.69|
74025547|NCT01193335|147604197|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.49|0.81||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.81|0.49|
74085082|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0048|TWO_SIDED|95.0|-1.11|-0.2||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 14~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.20|-1.11|0.0048
74025548|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.63|1.04||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.04|0.63|
74085083|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.003|TWO_SIDED|95.0|-1.15|-0.24||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 15~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.24|-1.15|0.0030
73856101|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.35|||<|0.001|TWO_SIDED|95.0|1.86|2.85|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.85|1.86|<0.001
73856102|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.12||||0.482|TWO_SIDED|95.0|-0.22|0.47|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|-0.22|0.482
73856103|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.573|TWO_SIDED|95.0|-0.44|0.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.24|-0.44|0.573
73856104|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.368|TWO_SIDED|95.0|-0.19|0.5|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.19|0.368
74025549|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.48|0.83||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.48|
74025550|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.84||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.84|0.46|
73856105|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.4|||<|0.001|TWO_SIDED|95.0|1.88|2.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.91|1.88|<0.001
73856106|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.66|2.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.68|1.66|<0.001
73906137|NCT01278160|147343261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.12||||95.0|-0.24|0.22|||ANCOVA|The estimates were from a normal linear regression model with treatment and previous insulin as factors, and baseline value as a covariate.||The null hypothesis is H0: μBIAsp 30 (2:1) - μBIAsp 30 (1:1) = 0 against the alternative hypothesis HA: μBIAsp 30 (2:1) - μBIAsp 30 (1:1) ≠ 0. This trial is an extension to BIAsp-3756 (NCT01123980), hence no particular sample size calculation was made.||0.22|-0.24|
73906138|NCT01278160|147343262|SUPERIORITY_OR_OTHER||Mixed models analysis|0.2||||0.2569||95.0|-0.15|0.56||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.56|-0.15|0.2569
73906139|NCT01278160|147343262|SUPERIORITY_OR_OTHER||Mixed models analysis|0.09||||0.812||95.0|-0.63|0.8||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.80|-0.63|0.8120
73906140|NCT01278160|147343262|SUPERIORITY_OR_OTHER||Mixed model analysis|0.35||||0.2843||95.0|-0.29|0.99||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.99|-0.29|0.2843
73906141|NCT01278160|147343262|SUPERIORITY_OR_OTHER||Mixed model analysis|0.3||||0.4614||95.0|-0.5|1.11||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||1.11|-0.50|0.4614
73906142|NCT01278160|147343262|SUPERIORITY_OR_OTHER||Mixed model analysis|0.44||||0.1591||95.0|-0.17|1.04||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||1.04|-0.17|0.1591
73906143|NCT01278160|147343262|SUPERIORITY_OR_OTHER||Mixed model analysis|0.03||||0.9327||95.0|-0.63|0.69||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.69|-0.63|0.9327
73906144|NCT01278160|147343262|SUPERIORITY_OR_OTHER||Mixed model analysis|-0.25||||0.4063||95.0|-0.84|0.34||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is bedtime profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.34|-0.84|0.4063
73906145|NCT01278160|147343262|SUPERIORITY_OR_OTHER||Mixed model analysis|0.3||||0.2198||95.0|-0.18|0.79||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is 2.00 - 4.00 a.m. profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.79|-0.18|0.2198
74025551|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.61|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.12|0.61|
74025552|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.5|||||TWO_SIDED|95.0|0.37|0.67||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.67|0.37|
74025553|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.4|0.72||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.40|
73906146|NCT01278160|147343262|SUPERIORITY_OR_OTHER||Mixed model analysis|-0.04||||0.8424||95.0|-0.47|0.38|||Mixed Models Analysis||Confidence interval is before breakfast the following day profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.38|-0.47|0.8424
73856107|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.44|||<|0.001|TWO_SIDED|95.0|1.93|2.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.96|1.93|<0.001
73856108|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.23|||<|0.001|TWO_SIDED|95.0|1.72|2.74|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.74|1.72|<0.001
73856109|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.352|TWO_SIDED|95.0|-0.19|0.53|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-0.19|0.352
73856110|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.771|TWO_SIDED|95.0|-0.41|0.3|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.41|0.771
73856111|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.235|TWO_SIDED|95.0|-0.14|0.58|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.58|-0.14|0.235
73856112|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.32|||<|0.001|TWO_SIDED|95.0|1.79|2.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.86|1.79|<0.001
73856113|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.05|||<|0.001|TWO_SIDED|95.0|1.52|2.58|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.52|<0.001
73856114|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.37|||<|0.001|TWO_SIDED|95.0|1.83|2.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.90|1.83|<0.001
73856115|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.2|||<|0.001|TWO_SIDED|95.0|1.66|2.73|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.73|1.66|<0.001
73856116|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.51|TWO_SIDED|95.0|-0.25|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.25|0.510
73856117|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.442|TWO_SIDED|95.0|-0.52|0.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.52|0.442
73856118|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.372|TWO_SIDED|95.0|-0.2|0.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.20|0.372
73856119|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.97|||<|0.001|TWO_SIDED|95.0|1.39|2.55|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.55|1.39|<0.001
73856120|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.82|||<|0.001|TWO_SIDED|95.0|1.25|2.4|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.40|1.25|<0.001
73856121|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.15|||<|0.001|TWO_SIDED|95.0|1.57|2.72|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.72|1.57|<0.001
73856122|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.87|||<|0.001|TWO_SIDED|95.0|1.3|2.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.45|1.30|<0.001
73856123|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.639|TWO_SIDED|95.0|-0.31|0.5|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.31|0.639
73856124|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.803|TWO_SIDED|95.0|-0.45|0.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.45|0.803
73906147|NCT01278160|147343263|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7312||95.0|0.36|2.06|||Regression, Logistic||The odds ratio and 95% confidence interval for the HbA1c below 7% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.||2.06|0.36|0.7312
73906148|NCT01278160|147343264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.1257||95.0|0.05|1.44|||Regression, Logistic|The estimates were from a normal linear regression model with treatment and previous insulin as factors, and baseline value as a covariate|The odds ratio and 95% confidence interval for the HbA1c below or equal to 6.5% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.||1.44|0.05|0.1257
73906149|NCT01278160|147343265|SUPERIORITY_OR_OTHER||Rate ratio|0.72||||0.1911||95.0|0.43|1.18|||Negative binomial regression model||For all episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.18|0.43|0.1911
73906150|NCT01278160|147343265|SUPERIORITY_OR_OTHER||Rate ratio|1.61||||0.2949||95.0|0.66|3.92|||Negative binomial regression model||For nocturnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||3.92|0.66|0.2949
73906151|NCT01278160|147343265|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.077||95.0|0.38|1.05|||Negative binomial regression model||For diurnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.05|0.38|0.0770
73906152|NCT01278160|147343265|SUPERIORITY_OR_OTHER||Rate ratio|0.56||||0.1687||95.0|0.25|1.27|||Negative binomial regression model||For minor episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.27|0.25|0.1687
73906153|NCT01483807|147343268|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.254|ONE_SIDED||||||t-test, 1 sided|||Comparison of performance (change in articulation accuracy) with SPT-R versus SPT-B items. Based on the existing literature, it was predicted that the mean effect size associated with SPT-R would be greater than that for SPT-B.||||.254
73906154|NCT01483807|147343269|SUPERIORITY||Mean Difference (Final Values)|8.25||||0.043|ONE_SIDED||||||t-test, 1 sided|||On the basis of existing literature. SPT-R was predicted to be associated with greater increase in articulatory accuracy over baseline levels than SPT-B.||||.043
73906155|NCT01483807|147343270|SUPERIORITY|||||||0.396|||||||t-test, 1 sided|||Comparison of change in accuracy of articulation of untreated items: SPT-R versus SPT-B items. It was predicted that there would be a greater increase in accuracy for SPT-R items.||||.396
73906156|NCT01483807|147343271|SUPERIORITY|||||||0.212|||||||t-test, 1 sided|||Comparison of effect sizes obtained for untreated SPT-R versus untreated SPT-B items. It was predicted that effect sizes would be greater for SPT-R untreated items.||||.212
73906157|NCT04755283|147343288|SUPERIORITY||Hazard Ratio (HR)|0.314|||<|0.001|TWO_SIDED|95.0|0.192|0.513|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.513|0.192|<0.001
73906158|NCT04755283|147343288|SUPERIORITY||Hazard Ratio (HR)|0.382|||<|0.001|TWO_SIDED|95.0|0.243|0.602|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.602|0.243|<0.001
73906159|NCT04755283|147343289|SUPERIORITY||Hazard Ratio (HR)|0.263|||<|0.001|TWO_SIDED|95.0|0.121|0.572|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.572|0.121|<0.001
73906160|NCT04755283|147343289|SUPERIORITY||Hazard Ratio (HR)|0.325||||0.001|TWO_SIDED|95.0|0.159|0.663|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.663|0.159|0.001
74025554|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.47|||||TWO_SIDED|95.0|0.35|0.64||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.64|0.35|
74025555|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.61|0.94||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.94|0.61|
74085084|NCT00407745|147723818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23||0.0011|TWO_SIDED|95.0|-1.22|-0.3||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 16~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.30|-1.22|0.0011
73906161|NCT04755283|147343290|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.332|0.638|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.638|0.332|<0.001
74025556|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.59|||||TWO_SIDED|95.0|0.39|0.9||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.39|
73906162|NCT04755283|147343290|SUPERIORITY||Hazard Ratio (HR)|0.683||||0.01|TWO_SIDED|95.0|0.512|0.912|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.912|0.512|0.010
73906163|NCT05597020|147343293|SUPERIORITY||Least Square mean difference vs placebo|20.9||||0.002|TWO_SIDED|95.0|8.0|33.7|||Mixed Models Analysis|Treatment, period, week within period, and interaction of treatment and week were factors; baseline sTST assessment was covariate.||||33.7|8.0|0.002
73906164|NCT03029702|147343295|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
73906165|NCT03029702|147343296|SUPERIORITY|||||||0.8|||||||Fisher Exact|||||||0.8
73906166|NCT03029702|147343297|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
73906167|NCT03029702|147343298|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
73906168|NCT03029702|147343299|SUPERIORITY|||||||0.8|||||||Fisher Exact|||||||0.8
73906169|NCT03029702|147343300|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
73906170|NCT03029702|147343301|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
73906171|NCT03029702|147343302|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
73906172|NCT05595382|147343330|SUPERIORITY|Repeated measures of likelihood to enroll (on a 1 to 7 scale with higher numbers indicating a greater likelihood) pre/post intervention||||||0.001|||||||ANOVA|Degrees of freedom (1, 359)||||||.001
73906173|NCT05595382|147343331|SUPERIORITY|||||||0.357|||||||ANOVA|Degrees of freedom (1, 358)||Repeated measures ANOVA comparing mood (rated on a 1-10 scale with higher scores indicating better mood) given to participants before and after the study manipulation by group||||.357
73906174|NCT05595382|147343332|SUPERIORITY|||||||0.102|||||||ANOVA|||||||.102
73906175|NCT02445391|147343341|NON_INFERIORITY|The null hypothesis for testing non-inferiority of platinum was defined as that the hazard ratio (HR) for platinum/capecitabine ≥ 1.154 (ie, HR of 1.154 was used as the non-inferiority margin). The alternative hypothesis was HR=0.754 for platinum/ capecitabine. The 4-year IDFS rate was expected to be 67% on capecitabine arm.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.62|1.81|||||The 95% confidence interval provided above was the Jennison and Turnbull repeated confidence interval.|||1.81|0.62|
74025557|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.52|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.52|
74025558|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.52|0.88||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.52|
73906176|NCT03722173|147343351|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|141.62|STANDARD_ERROR_OF_MEAN|13.3|||TWO_SIDED|90.0|129.64|154.71|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the geometric means (gMeans) (T/R) for AUC0-tz and their 2-sided 90% confidence intervals (CIs) were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||154.71|129.64|
73906177|NCT03722173|147343352|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|113.32|STANDARD_ERROR_OF_MEAN|15.1|||TWO_SIDED|90.0|102.47|125.32|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the gMeans (T/R) for Cmax and their 2-sided 90% CIs were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||125.32|102.47|
73906178|NCT03722173|147343353|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|142.54|STANDARD_ERROR_OF_MEAN|13.5|||TWO_SIDED|90.0|130.3|155.93|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the gMeans (T/R) for AUC0-∞ and their 2-sided 90% CIs were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||155.93|130.30|
73906179|NCT06624449|147343354|SUPERIORITY||Mean Difference (Final Values)|0.09|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
73906180|NCT00518687|147343374|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|18.5||||0.584|TWO_SIDED|95.0|-48.6|55.8||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significantly greater than 20%|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||55.8|-48.6|0.584
73906181|NCT00518687|147343375|SUPERIORITY_OR_OTHER||Estimated rate difference|0.0||||0.997|TWO_SIDED|95.0|-0.1|0.1|||Miettinen and Nurminen|||||0.1|-0.1|0.997
74025559|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.67|1.02||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.02|0.67|
74025560|NCT01193335|147604198|SUPERIORITY_OR_OTHER||GMC Ratio|0.51|||||TWO_SIDED|95.0|0.36|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.36|
73906182|NCT00518687|147343376|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|12.9||||0.347|TWO_SIDED|95.0|-50.8|50.0||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||50.0|-50.8|0.347
73906183|NCT00518687|147343377|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|29.3||||0.032|TWO_SIDED|95.0|-1.8|51.2||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||51.2|-1.8|0.032
73906184|NCT05108922|147343378|SUPERIORITY||Odds Ratio (OR)|29.26|||<|0.001|TWO_SIDED|95.0|5.3|100.0|||Regression, Logistic|||Analysis was based on logistic regression model with treatment, Apolipoprotein (ApoE) ε4 Carrier Status, baseline amyloid Level, baseline age as factors.||100.0|5.30|<0.001
73906185|NCT05108922|147343379|SUPERIORITY||Odds Ratio (OR)|15.18||||0.008|TWO_SIDED|95.0|2.04|100.0|||Regression, Logistic|||Analysis was based on logistic regression model with treatment, ApoE ε4 Carrier Status, baseline amyloid Level, baseline age as factors.||100.0|2.04|0.008
73906186|NCT05108922|147343380|SUPERIORITY||LS Mean difference (Final Values)|-45.691|STANDARD_ERROR_OF_MEAN|4.6132|<|0.001|TWO_SIDED|95.0|-54.84|-36.54||Analysis between treatment group comparison p-value using analysis of covariance (ANCOVA) model for endpoint measures: Change (CHG) = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-36.54|-54.84|<0.001
73906187|NCT05108922|147343381|SUPERIORITY||LS Mean difference (Final Values)|-48.213|STANDARD_ERROR_OF_MEAN|4.9276|<|0.001|TWO_SIDED|95.0|-57.99|-38.44||Analysis between treatment group comparison p-value using ANCOVA model for endpoint measures: Percent change (PCHG) = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-38.44|-57.99|<0.001
73906188|NCT05108922|147343382|SUPERIORITY||LS Mean difference (Final Values)|-40.252|STANDARD_ERROR_OF_MEAN|10.551|<|0.001|TWO_SIDED|95.0|-61.87|-18.64||Analysis between treatment group comparison p-value using ANCOVA model for endpoint measures: CHG = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-18.64|-61.87|<0.001
73906189|NCT05108922|147343383|SUPERIORITY||LS Mean difference (Final Values)|-23.97|STANDARD_ERROR_OF_MEAN|4.231|<|0.001|TWO_SIDED|95.0|-32.35|-15.6||Analysis between treatment group comparison p-value using mixed model for repeated measures (MMRM) model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-15.60|-32.35|<0.001
73906190|NCT05108922|147343384|SUPERIORITY||LS Mean difference (Final Values)|-25.82|STANDARD_ERROR_OF_MEAN|4.381|<|0.001|TWO_SIDED|95.0|-34.49|-17.15||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-17.15|-34.49|<0.001
73906191|NCT05108922|147343385|SUPERIORITY||Odds Ratio (OR)|8.38|||<|0.001|TWO_SIDED|95.0|3.37|20.81||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured|Regression, Logistic|||||20.81|3.37|<0.001
73906192|NCT05108922|147343386|SUPERIORITY||Odds Ratio (OR)|37.73|||<|0.001|TWO_SIDED|95.0|5.71|99.99||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Regression, Logistic|||||99.99|5.71|<.001
74025561|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.61|1.03||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.61|
74085085|NCT00407745|147723819|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.0256|TWO_SIDED|95.0|1.103|4.546||Significance was declared if p-value \<=0.05|Regression, Logistic|Logistic regression used terms for treatment, baseline pain score as covariate, baseline PCS total score, and pooled center as cofactor.||Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group.||4.546|1.103|0.0256
74085086|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.22||0.0004|TWO_SIDED|95.0|-1.23|-0.35||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 1.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.35|-1.23|0.0004
74085087|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.31|-0.43||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.43|-1.31|<0.0001
74025562|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.38|0.76||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.76|0.38|
73906193|NCT05108922|147343387|SUPERIORITY||LS Mean difference (Final Values)|-26.75|STANDARD_ERROR_OF_MEAN|6.479|<|0.001|TWO_SIDED|95.0|-39.78|-13.73||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-13.73|-39.78|<0.001
73906194|NCT05108922|147343388|SUPERIORITY||LS Mean difference (Final Values)|-7.931|STANDARD_ERROR_OF_MEAN|4.1187||0.0558|TWO_SIDED|95.0|-16.06|0.199||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||0.199|-16.060|0.0558
74025563|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.54|1.03||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.54|
74025564|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.51|1.17||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.51|
73856125|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.184|TWO_SIDED|95.0|-0.13|0.67|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.67|-0.13|0.184
73856126|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.67|||<|0.001|TWO_SIDED|95.0|1.07|2.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.26|1.07|<0.001
73856127|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.58|||<|0.001|TWO_SIDED|95.0|0.99|2.17|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.17|0.99|<0.001
73856128|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.84|||<|0.001|TWO_SIDED|95.0|1.25|2.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.43|1.25|<0.001
73856129|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.1|2.28|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.28|1.10|<0.001
73856130|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.02||||0.91|TWO_SIDED|95.0|-0.44|0.39|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.44|0.910
73856131|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.607|TWO_SIDED|95.0|-0.52|0.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.52|0.607
73856132|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.484|TWO_SIDED|95.0|-0.27|0.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.56|-0.27|0.484
73856133|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.64|1.86|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|0.64|<0.001
73856134|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.36|||<|0.001|TWO_SIDED|95.0|0.75|1.97|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.97|0.75|<0.001
73856135|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.38|||<|0.001|TWO_SIDED|95.0|0.77|1.99|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.99|0.77|<0.001
73856136|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5|||<|0.001|TWO_SIDED|95.0|0.89|2.1|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.10|0.89|<0.001
73856137|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.256|TWO_SIDED|95.0|-0.67|0.18|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.18|-0.67|0.256
73856138|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.526|TWO_SIDED|95.0|-0.56|0.29|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.29|-0.56|0.526
73856139|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.602|TWO_SIDED|95.0|-0.54|0.31|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.54|0.602
73856140|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.95||||0.002|TWO_SIDED|95.0|0.34|1.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.34|0.002
73856141|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.98||||0.001|TWO_SIDED|95.0|0.38|1.59|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.59|0.38|0.001
73856142|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.65|1.86|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|0.65|<0.001
73856143|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.22|||<|0.001|TWO_SIDED|95.0|0.61|1.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|0.61|<0.001
73856144|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.26||||0.224|TWO_SIDED|95.0|-0.69|0.16|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.16|-0.69|0.224
73856145|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.283|TWO_SIDED|95.0|-0.65|0.19|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.19|-0.65|0.283
73856146|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.86|TWO_SIDED|95.0|-0.39|0.46|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.46|-0.39|0.860
73906195|NCT05108922|147343389|NON_INFERIORITY|Non-inferiority margin of interest: 5 Centiloids|LS Mean difference (Final Values)|-7.931|STANDARD_ERROR_OF_MEAN|4.1187|||TWO_SIDED|95.0|-16.06|0.199||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||0.199|-16.060|
73906196|NCT05108922|147343390|SUPERIORITY||LS Mean difference (Final Values)|-12.04|STANDARD_ERROR_OF_MEAN|4.12||0.004|TWO_SIDED|95.0|-20.19|-3.88||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-3.88|-20.19|0.004
73906197|NCT05108922|147343391|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
73906198|NCT05108922|147343392|SUPERIORITY||LS Mean difference (Final Values)|-13.45|STANDARD_ERROR_OF_MEAN|4.3||0.002|TWO_SIDED|95.0|-21.96|-4.93||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-4.93|-21.96|0.002
73906199|NCT05108922|147343393|SUPERIORITY||Odds Ratio (OR)|4.68|||<|0.001|TWO_SIDED|95.0|1.93|11.34||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured.|Regression, Logistic|||||11.34|1.93|<0.001
73906200|NCT05108922|147343394|SUPERIORITY||Odds Ratio (OR)|6.34||||0.022|TWO_SIDED|95.0|1.32|30.54||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured.|Regression, Logistic|||||30.54|1.32|0.022
74025565|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.56|||||TWO_SIDED|95.0|0.4|0.78||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.78|0.40|
73856147|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.63||||0.038|TWO_SIDED|95.0|0.03|1.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.22|0.03|0.038
73856148|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.65||||0.031|TWO_SIDED|95.0|0.06|1.24|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|0.06|0.031
73856149|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03|||<|0.001|TWO_SIDED|95.0|0.43|1.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.62|0.43|<0.001
73906201|NCT05108922|147343395|SUPERIORITY||LS Mean difference (Final Values)|-14.33|STANDARD_ERROR_OF_MEAN|6.333||0.028|TWO_SIDED|95.0|-27.07|-1.59||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-1.59|-27.07|0.028
73906202|NCT05108922|147343396|NON_INFERIORITY|Non-inferiority margin of interest: 5 Centiloids.|LS Mean difference (Final Values)|7.831|STANDARD_ERROR_OF_MEAN|4.087|||TWO_SIDED|95.0|-0.226|15.889||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||15.889|-0.226|
74025566|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.45|||||TWO_SIDED|95.0|0.29|0.71||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.71|0.29|
74025567|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.56|||||TWO_SIDED|95.0|0.38|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.38|
73856150|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.95||||0.002|TWO_SIDED|95.0|0.36|1.54|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.54|0.36|0.002
73856151|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.32||||0.129|TWO_SIDED|95.0|-0.74|0.09|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.09|-0.74|0.129
73856152|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.3||||0.154|TWO_SIDED|95.0|-0.71|0.11|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.11|-0.71|0.154
73906203|NCT02339285|147343399|OTHER|F-test; Treatment effect|||||>|0.1|||||||ANOVA|F(2, 29)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."||||>0.10
73906204|NCT02339285|147343399|OTHER|F-test; Session effect|||||<|0.001|||||||ANOVA|F(1, 31)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."||||<0.001
73906205|NCT02339285|147343399|OTHER|F-test; Interaction effect (session x treatment)|||||>|0.1|||||||ANOVA|F(2,29)||||||>0.10
73906206|NCT02339285|147343400|OTHER|F-test; Condition effect|||||<|0.05|||||||ANOVA|F(2,21.595)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||<0.05
73906207|NCT02339285|147343400|OTHER|F-test; Region effect (region defined as region of brain - frontal, parietal, occipital temporal)|||||<|0.001|||||||ANOVA|F(3, 79.358)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||<0.001
73906208|NCT02339285|147343400|OTHER|F-test; Interaction effect (region x condition)|||||>|0.1|||||||ANOVA|F(6, 68.284)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||>0.10
73906209|NCT02339285|147343401|OTHER||||||>|0.1|||||||ANOVA|||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups."||||>0.10
73906210|NCT00537238|147343409|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the difference in proportion (Pregabalin - Levetiracetam) was greater than -0.12.|Difference in Proportion|0.0|||||TWO_SIDED|90.0|-0.08|0.09||||||||0.09|-0.08|
73906211|NCT00537238|147343410|SUPERIORITY_OR_OTHER_LEGACY||Median difference|4.1||||0.3571|TWO_SIDED|95.0|-2.6|10.9|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.||10.9|-2.6|0.3571
73906212|NCT00537238|147343412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0822|TWO_SIDED||||||Fisher Exact|||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.0822
73906213|NCT00537238|147343412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9175|TWO_SIDED||||||Fisher Exact|||Simple partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.9175
73906214|NCT00537238|147343412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0483|TWO_SIDED||||||Fisher Exact|||Complex partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.0483
73906215|NCT00537238|147343412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7139|TWO_SIDED||||||Fisher Exact|||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.7139
73906216|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|1.17|STANDARD_ERROR_OF_MEAN|0.78||0.1334|TWO_SIDED|95.0|-0.36|2.69|||ANCOVA|||Baseline, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||2.69|-0.36|0.1334
73906217|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.17|STANDARD_ERROR_OF_MEAN|0.18||0.3551|TWO_SIDED|95.0|-0.19|0.52|||ANCOVA|||Baseline, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.52|-0.19|0.3551
73906218|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.46|STANDARD_ERROR_OF_MEAN|0.5||0.3638|TWO_SIDED|95.0|-1.45|0.53|||ANCOVA|||Change at Week 7, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.53|-1.45|0.3638
73906219|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.2457|TWO_SIDED|95.0|-0.34|0.09|||ANCOVA|||Change at Week 7, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.09|-0.34|0.2457
73906220|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.23|STANDARD_ERROR_OF_MEAN|0.53||0.664|TWO_SIDED|95.0|-1.26|0.81|||ANCOVA|||Change at Week 10, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.81|-1.26|0.6640
73906221|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.595|TWO_SIDED|95.0|-0.3|0.17|||ANCOVA|||Change at Week 10, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.17|-0.30|0.5950
74025568|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.63|1.07||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.63|
74025569|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.39|1.11||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.11|0.39|
73906222|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.31|STANDARD_ERROR_OF_MEAN|0.55||0.5701|TWO_SIDED|95.0|-1.38|0.76|||ANCOVA|||Change at Week 13, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.76|-1.38|0.5701
73906223|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2452|TWO_SIDED|95.0|-0.33|0.08|||ANCOVA|||Change at Week 13, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.08|-0.33|0.2452
73906224|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.77|STANDARD_ERROR_OF_MEAN|0.56||0.1697|TWO_SIDED|95.0|-1.88|0.33|||ANCOVA|||Change at Week 16, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.33|-1.88|0.1697
73906225|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.2283|TWO_SIDED|95.0|-0.36|0.09|||ANCOVA|||Change at Week 16, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.09|-0.36|0.2283
73906226|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.35|STANDARD_ERROR_OF_MEAN|0.61||0.0262|TWO_SIDED|95.0|-2.54|-0.16|||ANCOVA|||Change at Follow-up, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||-0.16|-2.54|0.0262
73906227|NCT00537238|147343413|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.26|STANDARD_ERROR_OF_MEAN|0.13||0.0495|TWO_SIDED|95.0|-0.52|0.0|||ANCOVA|||Change at Follow-up, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.00|-0.52|0.0495
73906228|NCT00537238|147343414|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.09|STANDARD_ERROR_OF_MEAN|0.37||0.8084|TWO_SIDED|95.0|-0.82|0.64|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.64|-0.82|0.8084
73906229|NCT00537238|147343414|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.22|STANDARD_ERROR_OF_MEAN|0.35||0.5263|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.91|-0.47|0.5263
73906230|NCT00537238|147343414|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.25|STANDARD_ERROR_OF_MEAN|0.3||0.4008|TWO_SIDED|95.0|-0.34|0.85|||ANCOVA|||Week 16, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.85|-0.34|0.4008
73906231|NCT00537238|147343414|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.01|STANDARD_ERROR_OF_MEAN|0.3||0.9749|TWO_SIDED|95.0|-0.61|0.59|||ANCOVA|||Week 16, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.59|-0.61|0.9749
73906232|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.03|STANDARD_ERROR_OF_MEAN|2.06||0.6161|TWO_SIDED|95.0|-5.08|3.01|||ANCOVA|||Baseline sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.01|-5.08|0.6161
73906233|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.63|STANDARD_ERROR_OF_MEAN|1.62||0.3154|TWO_SIDED|95.0|-4.83|1.56|||ANCOVA|||Week 16 sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||1.56|-4.83|0.3154
74025570|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.5|0.92||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.92|0.50|
74025571|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.47|0.95||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.95|0.47|
74025572|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.7|1.13||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.13|0.70|
74025573|NCT01193335|147604199|SUPERIORITY_OR_OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.37|0.78||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.78|0.37|
74025574|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.81||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.81|0.99|
74025575|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.59|2.2||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.20|0.59|
74085088|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0004|TWO_SIDED|95.0|-1.24|-0.36||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 3.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.36|-1.24|0.0004
74085089|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23||0.0008|TWO_SIDED|95.0|-1.2|-0.32||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 4.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.32|-1.20|0.0008
73906234|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.7|STANDARD_ERROR_OF_MEAN|3.18||0.593|TWO_SIDED|95.0|-7.94|4.54|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||4.54|-7.94|0.5930
73906235|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|10.02|STANDARD_ERROR_OF_MEAN|2.42|<|0.0001|TWO_SIDED|95.0|5.27|14.76|||ANCOVA|||Week 16 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||14.76|5.27|<0.0001
73906236|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.54|STANDARD_ERROR_OF_MEAN|2.18||0.4807|TWO_SIDED|95.0|-5.83|2.75|||ANCOVA|||Baseline awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||2.75|-5.83|0.4807
73906237|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.88|STANDARD_ERROR_OF_MEAN|2.07||0.6708|TWO_SIDED|95.0|-3.18|4.94|||ANCOVA|||Week 16 awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||4.94|-3.18|0.6708
73906238|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7574|TWO_SIDED|95.0|-0.32|0.24|||ANCOVA|||Baseline quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||0.24|-0.32|0.7574
73906239|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.2615|TWO_SIDED|95.0|-0.1|0.38|||ANCOVA|||Week 16 quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||0.38|-0.10|0.2615
73906240|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.44|STANDARD_ERROR_OF_MEAN|2.53||0.5703|TWO_SIDED|95.0|-6.42|3.54|||ANCOVA|||Baseline adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.54|-6.42|0.5703
73906241|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-2.99|STANDARD_ERROR_OF_MEAN|2.41||0.216|TWO_SIDED|95.0|-7.74|1.75|||ANCOVA|||Week 16 adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||1.75|-7.74|0.2160
73906242|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|1.07|STANDARD_ERROR_OF_MEAN|2.02||0.5952|TWO_SIDED|95.0|-2.89|5.03|||ANCOVA|||Baseline somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||5.03|-2.89|0.5952
73906243|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.72|STANDARD_ERROR_OF_MEAN|1.87||0.6984|TWO_SIDED|95.0|-4.4|2.95|||ANCOVA|||Week 16 somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||2.95|-4.40|0.6984
73963556|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.21||||0.16|TWO_SIDED|95.0|0.88|1.66||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.|Eyes were analyzed.|Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||1.66|0.88|0.16
73906244|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.13|STANDARD_ERROR_OF_MEAN|1.64||0.9389|TWO_SIDED|95.0|-3.09|3.34|||ANCOVA|||Baseline sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.34|-3.09|0.9389
73906245|NCT00537238|147343415|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.64|STANDARD_ERROR_OF_MEAN|1.34||0.6344|TWO_SIDED|95.0|-2.0|3.27|||ANCOVA|||Week 16 sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.27|-2.00|0.6344
73906246|NCT00537238|147343416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.016||||0.9285|TWO_SIDED|95.0|0.715|1.444|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||1.444|0.715|0.9285
73906247|NCT00537238|147343416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.432||||0.0696|TWO_SIDED|95.0|0.972|2.11|||Regression, Logistic|||Week 16: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||2.110|0.972|0.0696
73906248|NCT05015530|147343483|SUPERIORITY|||||||0.908|||||||Kruskal-Wallis|||α-diversity assessed using the Kruskal-Wallis test||||0.908
73906249|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.375
73906250|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||0.156
73906251|NCT01325623|147343509|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months||||>0.999
73906252|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.906
73906253|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.188
73906254|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.906
73906255|NCT01325623|147343509|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||<0.001
73906256|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||0.106
73906257|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||0.012
73906258|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.008
73906259|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.009
73906260|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.029
74025576|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.26|1.93||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.93|0.26|
73906261|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.500
73906262|NCT01325623|147343509|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||>0.999
73906263|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||0.500
73906264|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.500
73906265|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.188
73906266|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.500
73906267|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.500
73906268|NCT01325623|147343509|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||>0.999
73906269|NCT01325623|147343509|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||>0.999
73906270|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.125
74025577|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.8|1.98||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.98|0.80|
73906271|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.500
73906272|NCT01325623|147343509|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.500
73906273|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.1529|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.1529
73906274|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.0942|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0942
73906275|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.2831|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.2831
73906276|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.3639|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.3639
73906277|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.447|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.4470
73906278|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.1311|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.1311
73906279|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.3898|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.3898
73963557|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-10.0|||||TWO_SIDED|95.0|-16.0|-5.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||-5|-16|
73963558|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-10.0|||||TWO_SIDED|95.0|-16.0|-4.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||-4|-16|
73963559|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|1.0|||||TWO_SIDED|95.0|-7.0|9.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||9|-7|
73963560|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.24|||<|0.001|TWO_SIDED|95.0|0.09|0.65||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||0.65|0.09|<0.001
73906280|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0511
73906281|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0019
73906282|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.1106|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.1106
73906283|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.1273|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.1273
73906284|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.1305|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.1305
73906285|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.1123|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.1123
73906286|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.2309|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.2309
73906287|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.3191|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.3191
73963561|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.24||||0.001|TWO_SIDED|95.0|0.08|0.68||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||0.68|0.08|0.001
73963562|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.08||||0.75|TWO_SIDED|95.0|0.62|1.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||1.87|0.62|0.75
73963563|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|16.0|||||TWO_SIDED|95.0|6.0|26.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between to study eyes.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||26|6|
74025578|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.01|2.0||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.00|1.01|
73906288|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.0679|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0679
73906289|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.2082|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.2082
73906290|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.1790
73906291|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.6869|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.6869
73906292|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.6094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.6094
73906293|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.1530
73906294|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.3339|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.3339
73906295|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.1473|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.1473
73906296|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.5035|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.5035
73906297|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.6653|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.6653
73906298|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.8622
73963564|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|13.0|||||TWO_SIDED|95.0|4.0|22.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||22|4|
74025579|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.82|1.89||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.89|0.82|
73906299|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.4456|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.4456
73906300|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.6876|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.6876
73906301|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.0328|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0328
73906302|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0067
73906303|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.5928|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.5928
73906304|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.7179|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.7179
73906305|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.5014|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.5014
73906306|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.964|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.9640
73963565|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|6.0|||||TWO_SIDED|95.0|-2.0|15.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||15|-2|
73963566|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.09|||<|0.001|TWO_SIDED|95.0|1.35|3.22|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||3.22|1.35|<0.001
73906307|NCT01325623|147343510|SUPERIORITY_OR_OTHER|||||||0.8537|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.8537
73906308|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.2079|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.2079
73906309|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.6562|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.6562
73906310|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.9376|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.9376
73906311|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0100
73906312|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.8532|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.8532
73906313|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.4954|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.4954
73906314|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.1877|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.1877
73906315|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.4189|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.4189
73906316|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.2365|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.2365
73906317|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.4138|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.4138
73906318|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.8701|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.8701
73906319|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0527|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0527
73906320|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.1353|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.1353
73906321|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.6927|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.6927
73906322|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.4964|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.4964
73963567|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.89|||<|0.001|TWO_SIDED|95.0|1.25|2.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||2.87|1.25|<0.001
73963568|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.43||||0.07|TWO_SIDED|95.0|0.9|2.29||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||2.29|0.90|0.07
73906323|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0238|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0238
73906324|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0139|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0139
73906325|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.2822|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.2822
73906326|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.1363|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.1363
73906327|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0019
73906328|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.1293|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.1293
73906329|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.5252|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.5252
73906330|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0642|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0642
73906331|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0025
73906332|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0024
73906333|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.4464|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.4464
73906334|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.0511
73906335|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0002
73906336|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0296|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score||||0.0296
73906337|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.3115|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.3115
73906338|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0270
73963569|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-6.0|||||TWO_SIDED|95.0|-11.0|-2.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||-2|-11|
73963570|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-6.0|||||TWO_SIDED|95.0|-10.0|-1.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||-1|-10|
73963571|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Proportion|0.0|||||TWO_SIDED|95.0|-6.0|6.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||6|-6|
73963572|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.21||||0.009|TWO_SIDED|95.0|0.05|0.87|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||0.87|0.05|0.009
73963573|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.28||||0.01|TWO_SIDED|95.0|0.08|0.97|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||0.97|0.08|0.01
73963574|NCT00444600|147462706|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.02||||0.95|TWO_SIDED|95.0|0.47|2.2|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||2.20|0.47|0.95
73963575|NCT00444600|147462707|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.0|||<|0.001|TWO_SIDED|95.0|1.52|2.64||Confidence intervals are adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.64|1.52|<0.001
73963576|NCT00444600|147462707|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.55||||0.001|TWO_SIDED|95.0|1.13|2.13||Confidence intervals adjusted for multiple comparisons|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.13|1.13|0.001
73963577|NCT00444600|147462707|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.76|||<|0.001||95.0|1.31|2.36||Confidence intervals adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.36|1.31|<0.001
73963578|NCT00444600|147462717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.08
73963579|NCT00444600|147462717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.17
73963580|NCT00444600|147462718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.03
73963581|NCT00444600|147462718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.17
73963582|NCT00444600|147462722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.01|-0.44||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.44|-1.01|<0.001
73906339|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0008
73906340|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0683|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0683
73906341|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.2226|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.2226
73906342|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0823|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.0823
73906343|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.1459|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.1459
73906344|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score||||0.2610
73906345|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.9119|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||||||0.9119
73906346|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0826|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0826
73906347|NCT01325623|147343514|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0036
73963583|NCT00444600|147462722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.68|||<|0.001|TWO_SIDED|95.0|-0.96|-0.41||Confidence intervals adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.41|-0.96|<0.001
73906348|NCT00145600|147343517|SUPERIORITY_OR_OTHER_LEGACY||KM Event-free survival estimate|0.886|||||TWO_SIDED|95.0|0.82|0.953||||||||0.953|0.820|
73906349|NCT00145600|147343517|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.844|||||TWO_SIDED|95.0|0.739|0.95||||||||0.950|0.739|
73906350|NCT00145600|147343517|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.667|||||TWO_SIDED|95.0|0.4|0.933||||||||0.933|0.400|
73963584|NCT00444600|147462722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.91|-0.34||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.34|-0.91|<0.001
73963585|NCT05132478|147462724|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||||||0.720
73963586|NCT05132478|147462725|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
73963587|NCT05132478|147462726|SUPERIORITY|||||||0.228|||||||t-test, 2 sided|||baseline||||0.228
73963588|NCT05132478|147462726|SUPERIORITY|||||||0.176|||||||t-test, 2 sided|||Post-Intervention||||0.176
73963589|NCT05132478|147462727|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||baseline||||0.410
73906351|NCT00145600|147343517|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.793|||||TWO_SIDED|95.0|0.726|0.86||||||||0.860|0.726|
73906352|NCT00145600|147343518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3097||95.0|||||Wilcoxon signed rank test|||||||0.3097
73963590|NCT05132478|147462727|SUPERIORITY|||||||0.351|||||||ANOVA|||Post-Intervention||||0.351
73963591|NCT05132478|147462728|SUPERIORITY||||||<|0.001||||||calculated p-value|t-test, 2 sided|||||||<0.001
73906353|NCT00145600|147343518|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906354|NCT00145600|147343518|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
73906355|NCT00145600|147343518|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906356|NCT00145600|147343518|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
73906357|NCT00145600|147343518|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906358|NCT00145600|147343518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0197||95.0|||||Wilcoxon signed rank test|||||||0.0197
73906359|NCT00145600|147343518|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906360|NCT00145600|147343519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
73906361|NCT00145600|147343519|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906362|NCT00145600|147343519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
73963592|NCT05132478|147462729|SUPERIORITY||||||<|0.001||||||calculated p-value|t-test, 2 sided|||||||<0.001
73963593|NCT02549170|147462730|SUPERIORITY||Newcombe confidence interval|-21.8|||=|0.0045|TWO_SIDED|95.0|-34.45|-7.94|||Chi-squared|||||-7.94|-34.45|=0.0045
73963594|NCT02549170|147462732|SUPERIORITY||Newcombe confidence interval|-16.9|||=|0.0896|TWO_SIDED|95.0|-33.02|0.69||The treatment groups were compared using a continuity-corrected chi-square test.|Chi-squared, Corrected|||||0.69|-33.02|=0.0896
73963595|NCT02549170|147462733|SUPERIORITY||||||=|0.002|||||||Wilcoxon Survival Test|||||||=0.002
73963596|NCT02549170|147462734|SUPERIORITY||Least Square Mean|5.2|||=|0.03|TWO_SIDED|95.0|0.5|9.9|||ANCOVA|||||9.9|0.5|=0.030
73963597|NCT03224390|147462800|SUPERIORITY||Instrumental variables estimate|0.41|||||TWO_SIDED|95.0|-0.03|0.85||||||||.85|-.03|
73906363|NCT00145600|147343519|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
74025580|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.8|1.99||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.99|0.80|
74025581|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.56|1.15||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.56|
74025582|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.83|1.41||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.41|0.83|
74025583|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.36|0.94||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.94|0.36|
74025584|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.88|1.68||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.68|0.88|
74025585|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.78|1.39||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.39|0.78|
74025586|NCT01193335|147604205|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.89|1.51||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.51|0.89|
74025587|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.37|1.44||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.44|0.37|
73906364|NCT00145600|147343519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
74025588|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.37|1.71||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.71|0.37|
73906365|NCT00145600|147343519|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
74025589|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|0.76|3.12||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||3.12|0.76|
74025590|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.33|1.17||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.33|
74025591|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.24|1.55||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.55|0.24|
73906366|NCT00145600|147343519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3624||95.0|||||Wilcoxon signed rank test|||||||0.3624
74025592|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.97|1.77||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.77|0.97|
74025593|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.35|1.46||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.46|0.35|
74025594|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|1.0|1.6||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.60|1.00|
73906367|NCT00145600|147343519|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906368|NCT00145600|147343520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0254||95.0|||||Wilcoxon signed rank test|||||||0.0254
73906369|NCT00145600|147343520|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.44|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906370|NCT00145600|147343520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0|||||Wilcoxon signed rank test|||||||0.0004
73906371|NCT00145600|147343520|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.32||||0.0001||95.0|||||Spearman Correlation Coefficients|||||||0.0001
73906372|NCT00145600|147343520|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon Correlation Coefficients|||||||<0.0001
73906373|NCT00145600|147343520|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906374|NCT00145600|147343520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
73906375|NCT00145600|147343520|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.26||||0.0061||95.0|||||Spearman Correlation Coefficients|||||||0.0061
73906376|NCT00145600|147343521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0687||95.0|||||Wilcoxon signed rank test|||||||0.0687
73906377|NCT00145600|147343521|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.65|||<|0.0001||95.0|||||Spearman Correlation Coefficient|||||||<0.0001
73906378|NCT00145600|147343521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9478||95.0|||||Wilcoxon signed rank test|||||||0.9478
73906379|NCT00145600|147343521|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906380|NCT00145600|147343521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2999||95.0|||||Wilcoxon signed rank test|||||||0.2999
73906381|NCT00145600|147343521|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906382|NCT00145600|147343521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3121||95.0|||||Wilcoxon signed rank test|||||||0.3121
73906383|NCT00145600|147343521|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906384|NCT00145600|147343522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
73906385|NCT00145600|147343522|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.57|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906386|NCT00145600|147343522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0282||95.0|||||Wilcoxon signed rank test|||||||0.0282
73906387|NCT00145600|147343522|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.35||||0.0002||95.0|||||Spearman Correlation Coefficients|||||||0.0002
73906388|NCT00145600|147343522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0038||95.0|||||Wilcoxon signed rank test|||||||0.0038
73906389|NCT00145600|147343522|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906390|NCT00145600|147343522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1474||95.0|||||Wilcoxon signed rank test|||||||0.1474
73906391|NCT00145600|147343522|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906392|NCT00145600|147343523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0281||95.0|||||Wilcoxon signed rank test|||||||0.0281
73906393|NCT00145600|147343523|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.63|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906394|NCT00145600|147343523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Wilcoxon signed rank test|||||||0.0050
73906395|NCT00145600|147343523|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.45|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906396|NCT00145600|147343523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Wilcoxon signed rank test|||||||0.0005
73906397|NCT00145600|147343523|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37||||0.0001||95.0|||||Spearman Correlation Coefficients|||||||0.0001
73906398|NCT00145600|147343523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552||95.0|||||Wilcoxon signed rank test|||||||0.0552
73906399|NCT00145600|147343523|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906400|NCT00145600|147343524|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
73906401|NCT00145600|147343524|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.53|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906402|NCT00145600|147343524|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxan signed rank test|||||||<0.0001
73906403|NCT00145600|147343524|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.68|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906404|NCT00145600|147343524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Wilcoxon signed rank test|||||||0.0017
73906405|NCT00145600|147343524|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906406|NCT00145600|147343525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2758||95.0|||||Wilcoxon signed rank test|||||||0.2758
73906407|NCT00145600|147343525|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906408|NCT00145600|147343525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1731||95.0|||||Wilcoxon signed rank test|||||||0.1731
73906409|NCT00145600|147343525|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906410|NCT00145600|147343525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846||95.0|||||Wilcoxon signed rank test|||||||0.0846
73906411|NCT00145600|147343525|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906412|NCT00145600|147343526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4263||95.0|||||Wilcoxon signed rank test|||||||0.4263
73906413|NCT00145600|147343526|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906414|NCT00145600|147343526|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
73906415|NCT00145600|147343526|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906416|NCT00145600|147343526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0468||95.0|||||Wilcoxon signed rank test|||||||0.0468
73906417|NCT00145600|147343526|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906418|NCT00145600|147343527|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
73906419|NCT00145600|147343527|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.26||||0.0019||95.0|||||Spearman Correlation Coefficients|||||||0.0019
73906420|NCT00145600|147343527|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
73906421|NCT00145600|147343527|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.16||||0.0704||95.0|||||Spearman Correlation Coefficients|||||||0.0704
74085090|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.38|-0.49||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 5.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.49|-1.38|<0.0001
74085091|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.37|-0.48||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 6.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.48|-1.37|<0.0001
73906422|NCT00145600|147343527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon signed rank test|||||||0.0200
73906423|NCT00145600|147343527|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906424|NCT00145600|147343528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7192||95.0|||||Wilcoxon signed rank test|||||||0.7192
73906425|NCT00145600|147343528|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906426|NCT00145600|147343528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8663||95.0|||||Wilcoxon signed rank test|||||||0.8663
73906427|NCT00145600|147343528|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906428|NCT00145600|147343528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7626||95.0|||||Wilcoxon signed rank test|||||||0.7626
73906429|NCT00145600|147343528|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.58|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906430|NCT00145600|147343529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4807||95.0|||||Wilcoxon signed rank test|||||||0.4807
73906431|NCT00145600|147343529|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.36|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906432|NCT00145600|147343529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0824||95.0|||||Wilcoxon signed rank test|||||||0.0824
73906433|NCT00145600|147343529|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906434|NCT00145600|147343529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0496||95.0|||||Wilcoxon signed rank test|||||||0.0496
73963598|NCT00703820|147462802|SUPERIORITY||Odds Ratio (OR)|1.87||||0.035|TWO_SIDED|95.0|1.03|3.41||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.0429 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using an exact, risk-group stratified, two-sided test.|The odds ratio is defined as the ratio of the odds that a Clofarabine+Cytarabine patient is MRD positive to the odds that a Cytarabine+Daunorubicin+Etoposide patient is MRD positive.|The study was designed to test the null hypothesis that Cytarabine+Daunorubicin+Etoposide and Clofarabine+Cytarabine result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 240 MRD-evaluable patients in a 5-stage Haybittle-Peto group sequential design gives 80% power at the 5% level to detect an odds ratio of 2.5. The design was developed using East statistical software.||3.41|1.03|0.035
73963599|NCT00914589|147462811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0482||||0.8648||95.0|0.6095|1.8029||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.8029|0.6095|0.8648
73963600|NCT00914589|147462811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9871||||0.9634||95.0|0.5673|1.7176||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.7176|0.5673|0.9634
73963601|NCT03988023|147462816|SUPERIORITY|||||||0.32|||||||MMRM|||||||0.32
73963602|NCT03988023|147462817|SUPERIORITY|||||||0.3|||||||MMRM|||||||0.30
73963603|NCT01195883|147462829|SUPERIORITY||Risk Ratio (RR)|0.9||||0.51|TWO_SIDED|95.0|0.65|1.23|||GEE model|||||1.23|0.65|0.51
73963604|NCT01195883|147462830|SUPERIORITY||Risk Ratio (RR)|0.95||||0.42|TWO_SIDED|95.0|0.81|1.11|||Chi-squared|||||1.11|0.81|0.42
73963605|NCT01195883|147462831|SUPERIORITY||Risk Ratio (RR)|0.89||||0.26|TWO_SIDED|95.0|0.72|1.09|||Chi-squared|||||1.09|0.72|0.26
73963606|NCT01195883|147462832|SUPERIORITY||Odds Ratio (OR)|1.33||||0.4|TWO_SIDED|95.0|0.69|2.58|||Chi-squared|||||2.58|0.69|0.40
73963607|NCT04470375|147462842|OTHER|Paired samples pre-post t-test||||||0.137|||||||t-test, 2 sided|||||||.137
73963608|NCT04470375|147462843|OTHER|Paired samples t-test (pre - post measure of group)||||||0.01|||||||t-test, 2 sided|||||||.010
73906435|NCT00145600|147343529|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906436|NCT00145600|147343530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0157||95.0|||||Wilcoxon signed rank test|||||||0.0157
73906437|NCT00145600|147343530|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906438|NCT00145600|147343530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
73906439|NCT00145600|147343530|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906440|NCT00145600|147343530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1478||95.0|||||Wilcoxon signed rank test|||||||0.1478
73906441|NCT00145600|147343530|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.56|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73963609|NCT04470375|147462844|OTHER|Paired samples t-test (pre post measure of group)||||||0.591|||||||t-test, 2 sided|||||||.591
73963610|NCT04629950|147462850|SUPERIORITY|||||||0.395||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||||||0.395
73963611|NCT04629950|147462850|SUPERIORITY|||||||0.41||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.410
73963612|NCT04629950|147462851|SUPERIORITY|||||||0.691|||||||Fisher Exact|||||||0.691
74025595|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.68|1.33||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.33|0.68|
74025596|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.31||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.82|
74085092|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.35|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 7.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.35|<0.0001
73906442|NCT00145600|147343531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0831||95.0|||||Wilcoxon signed rank test|||||||0.0831
73906443|NCT00145600|147343531|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.25||||0.0027||95.0|||||Spearman Correlation Coefficients|||||||0.0027
73906444|NCT00145600|147343531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0135||95.0|||||Wilcoxon signed rank test|||||||0.0135
73906445|NCT00145600|147343531|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.27||||0.0024||95.0|||||Spearman Correlation Coefficients|||||||0.0024
73906446|NCT00145600|147343531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9848||95.0|||||Wilcoxon signed rank test|||||||0.9848
73906447|NCT00145600|147343531|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.16||||0.0974||95.0|||||Spearman Correlation Coefficients|||||||0.0974
73906448|NCT00145600|147343532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||Wilcoxon signed rank test|||||||0.0040
73906449|NCT00145600|147343532|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906450|NCT00145600|147343532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Wilcoxon signed rank test|||||||0.0012
73906451|NCT00145600|147343532|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906452|NCT00145600|147343532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8108||95.0|||||Wilcoxon signed rank test|||||||0.8108
73906453|NCT00145600|147343532|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
73906454|NCT00145600|147343533|SUPERIORITY_OR_OTHER_LEGACY||KM Event-free survival estimate|0.874|||||TWO_SIDED|95.0|0.805|0.944||||||||0.944|0.805|
73906455|NCT00145600|147343533|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.844|||||TWO_SIDED|95.0|0.739|0.95||||||||0.950|0.739|
73906456|NCT00145600|147343533|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.667|||||TWO_SIDED|95.0|0.4|0.933||||||||0.933|0.400|
73906457|NCT00145600|147343533|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.785|||||TWO_SIDED|95.0|0.716|0.853||||||||0.853|0.716|
73906458|NCT01539642|147343538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.02|STANDARD_ERROR_OF_MEAN|15.25||0.001|TWO_SIDED|95.0|19.89|80.14|||ANCOVA|||||80.14|19.89|0.001
73906459|NCT02600351|147343561|NON_INFERIORITY|With a 10% non-inferiority margin, a sample size of 90 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 98% for both groups.|Difference in percentages|-18.8||||0.065|TWO_SIDED|95.0|-40.7|3.2|||Cochran-Mantel-Haenszel|||||3.2|-40.7|0.065
73906460|NCT02600351|147343561|NON_INFERIORITY|With a 10% non-inferiority margin, a sample size of 125 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 95% for both groups.|Difference in percentages|-11.7||||0.25|TWO_SIDED|95.0|-32.1|8.8|||Cochran-Mantel-Haenszel|||||8.8|-32.1|0.25
73906461|NCT00567593|147343570|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test||||||.01
73906462|NCT00438451|147343580|SUPERIORITY_OR_OTHER|||||||0.0201||95.0|||||Fisher Exact|||||||0.0201
73906463|NCT00438451|147343580|SUPERIORITY_OR_OTHER|||||||0.1536||95.0|||||Fisher Exact|||||||0.1536
73906464|NCT00438451|147343580|SUPERIORITY_OR_OTHER|||||||0.3615||95.0|||||Fisher Exact|||||||0.3615
73906465|NCT00438451|147343580|SUPERIORITY_OR_OTHER|||||||0.0478||95.0|||||Fisher Exact|||||||0.0478
73906466|NCT00438451|147343580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.838||||0.0578|TWO_SIDED|95.0|1.092|3.093|||Regression, Logistic|adjusted for treatment (p=0.0578), country (p=0.4649), pooled sites (p=0.4420) and number of concurrent diseases (p=0.0192)|"Odds ratio given here is for comparison LEV vs CBZ: OR=1.838 KI=(1.092-3.093) LEV vs LTG: OR=1.169 KI=(0.689-1.984) CBZ vs LTG: OR=0.636 KI=(0.377-1.073) Number of concurrent diseases: OR=0.921 KI=(0.859-0.987)"|||3.093|1.092|0.0578
73906467|NCT00438451|147343581|SUPERIORITY_OR_OTHER|||||||0.0596||95.0|||||Log Rank|||||||0.0596
73906468|NCT00438451|147343582|SUPERIORITY_OR_OTHER|||||||0.2517||95.0|||||Fisher Exact|||||||0.2517
73906469|NCT00438451|147343583|SUPERIORITY_OR_OTHER|||||||0.3303||95.0|||||Fisher Exact|||||||0.3303
73906470|NCT00438451|147343584|SUPERIORITY_OR_OTHER|||||||0.5022||95.0|||||Log Rank|||||||0.5022
73906471|NCT02413372|147343592|SUPERIORITY||Mean Difference (Final Values)|-7.17|||||TWO_SIDED|90.0|-9.09|-5.26|||||mean difference in adjusted change from baseline vs placebo|Day 57||-5.26|-9.09|
73906472|NCT02413372|147343592|SUPERIORITY||Mean Difference (Final Values)|-5.19|||||TWO_SIDED|90.0|-7.14|-3.25|||||mean difference in adjusted change from baseline vs placebo|Day 57||-3.25|-7.14|
73906473|NCT02413372|147343592|SUPERIORITY||Mean Difference (Final Values)|-5.43||||0.0004|TWO_SIDED|90.0|-8.01|-2.84|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112||-2.84|-8.01|0.0004
73906474|NCT02413372|147343592|SUPERIORITY||Mean Difference (Final Values)|-3.85||||0.0084|TWO_SIDED|90.0|-6.47|-1.23|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112||-1.23|-6.47|0.0084
73906475|NCT02556203|147343608|NON_INFERIORITY|1-sided Confidence interval|Hazard Ratio (HR)|1.2089302|||||ONE_SIDED|97.5||1.7040824||||||"H0: HR(t)\>=1.20 for all time points t\>=0, (i.e. the hazard for the primary efficacy endpoint in the rivaroxaban-based treatment group is more than 20% larger than that in the antiplatelet-based control group)"||1.7040824||
73906476|NCT02556203|147343609|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.35|||=|0.04223|TWO_SIDED|95.0|1.01|1.81|||Log Rank|||||1.81|1.01|= 0.04223
73906477|NCT02556203|147343610|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.5|||=|0.07745|TWO_SIDED|95.0|0.95|2.37|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.37|0.95|= 0.07745
73906478|NCT02556203|147343611|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.39|||=|0.01156|TWO_SIDED|95.0|1.08|1.8|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||1.80|1.08|= 0.01156
73906479|NCT02556203|147343612|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.22|||=|0.21595|TWO_SIDED|95.0|0.89|1.69|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||1.69|0.89|= 0.21595
73906480|NCT02556203|147343613|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.78|||=|0.02216|TWO_SIDED|95.0|1.08|2.94|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.94|1.08|= 0.02216
73906481|NCT02556203|147343614|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.66|||=|0.02702|TWO_SIDED|95.0|1.05|2.62|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.62|1.05|= 0.02702
73906482|NCT02556203|147343615|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.84|||=|1e-05|TWO_SIDED|95.0|1.41|2.41|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.41|1.41|= 0.00001
73906483|NCT00739999|147343628|SUPERIORITY_OR_OTHER_LEGACY||Atorvastatin CL/F based on 70 kg BW|699.0|||||TWO_SIDED|95.0|570.0|881.0|||non-linear mixed-effects model|Measures of parameter estimation uncertainty (95% CI) were determined by non-parametric bootstrap analysis.||Atorvastatin apparent clearance (CL/F) was described as a function of body weight using an allometric equation. The estimated parameter given is an extrapolation of the model for participants who weigh 70 kg.||881|570|
73906484|NCT03875768|147343687|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|1.72||0.89|TWO_SIDED|95.0|-0.44|0.5||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size is 0.5. The investigators hypothesize that the intervention will lead to an increase in average DASH score of 2 units. The investigators used a standard deviation for 2 units for both intervention and attention control groups since higher variability may be observed with a bigger sample size than the pilot study.||0.50|-0.44|0.89
73906485|NCT03875768|147343688|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|13.0||0.26|TWO_SIDED|95.0|-5.3|1.4||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size for change in systolic blood pressure (SBP) between intervention and control group is 0.6 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.||1.4|-5.3|0.26
73906486|NCT03875768|147343689|SUPERIORITY||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|8.3||0.39|TWO_SIDED|95.0|-3.1|1.2||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size for change in diastolic blood pressure (DBP) between intervention and control group is 0.75 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.||1.2|-3.1|0.39
73963613|NCT04629950|147462851|SUPERIORITY|||||||1||||||P values not adjusted for multiple comparisons.|Fisher Exact|||||||1
73963614|NCT04629950|147462852|SUPERIORITY|||||||0.758|||||||t-test, 2 sided|P value not adjusted for multiple comparisons,||||||0.758
73963615|NCT04629950|147462852|SUPERIORITY|||||||0.247||||||P values not adjusted for multiple comparisons.|Fisher Exact|||Data represent change values.||||0.247
73963616|NCT04629950|147462853|SUPERIORITY|||||||0.316||||||P values were not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.316
73963617|NCT04629950|147462853|SUPERIORITY|||||||0.605||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||Data represent change values.||||0.605
74025597|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.24|1.04||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.04|0.24|
74025598|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.58|2.53||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.53|0.58|
74025599|NCT01193335|147604206|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.52|1.37||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.37|0.52|
74025600|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.45|0.97||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.97|0.45|
74025601|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.54|1.4||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.40|0.54|
74025602|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.41|1.31||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.41|
74025603|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.14||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.14|0.54|
74025604|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.34|0.87||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.34|
74025605|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.31|1.1||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.10|0.31|
74085093|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.35|-0.46||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 8.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.46|-1.35|<0.0001
74025606|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.4|1.01||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.01|0.40|
74025607|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.38|0.81||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.81|0.38|
74025608|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.76|1.17||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.76|
74025609|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.45|0.91||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.91|0.45|
74085094|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.39|-0.5||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 9.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.50|-1.39|<0.0001
74085095|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.53|-0.63||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 10.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.63|-1.53|<0.0001
74025610|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.47|0.85||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.85|0.47|
74025611|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.15||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.74|
74025612|NCT01193335|147604207|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.52|0.88||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.52|
73906487|NCT01925274|147343699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.71||||0.164|TWO_SIDED|95.0|-83.4|12.0|||Chi-squared|||||12.0|-83.4|0.164
73906488|NCT00777205|147343739|SUPERIORITY_OR_OTHER||Slope|0.22|||<|0.05|TWO_SIDED|95.0|-1.57|2.01|||Mixed Models Analysis|||||2.01|-1.57|<0.05
73906489|NCT00777205|147343740|SUPERIORITY_OR_OTHER||Slope|-0.39|||<|0.05|TWO_SIDED|95.0|-2.03|1.24|||Mixed Models Analysis|||||1.24|-2.03|<0.05
73906490|NCT00777205|147343741|SUPERIORITY_OR_OTHER||Slope|0.81|||<|0.05|TWO_SIDED|95.0|-0.93|2.55|||Mixed Models Analysis|||||2.55|-0.93|<0.05
73906491|NCT00777205|147343742|SUPERIORITY_OR_OTHER||Slope|-0.039|||<|0.05|TWO_SIDED|95.0|-2.66|1.89|||Mixed Models Analysis|||||1.89|-2.66|<0.05
73906492|NCT00777205|147343743|SUPERIORITY_OR_OTHER||Slope|-0.08|||||TWO_SIDED|95.0|-3.31|3.16||||||||3.16|-3.31|
73963618|NCT04629950|147462854|SUPERIORITY|||||||0.192||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Average Itch||||0.192
74025613|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.35|2.05||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.05|0.35|
73906493|NCT00100178|147343744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.47
73906494|NCT02477839|147343747|OTHER||Mean Difference (Final Values)|0.97|||||TWO_SIDED|95.0|0.83|1.14|||ANCOVA|||Difference ratio in LS Mean was calculated as the exp \[LSMLCM-LSMplacebo\].||1.14|0.83|
74085096|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.39|-0.49||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 11.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.49|-1.39|<0.0001
73963619|NCT04629950|147462854|SUPERIORITY|||||||0.392||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Average Itch. Data represent change values.||||0.392
73963620|NCT04629950|147462854|SUPERIORITY|||||||0.347||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||Mean Reduction in Maximum Itch||||0.347
74025614|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.41|2.63||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.63|0.41|
73906495|NCT02477839|147343747|OTHER||Percent reduction|3.19|||=|0.6895|TWO_SIDED|95.0|-13.59|17.5|||ANCOVA|||Percent reduction over placebo was estimated as 100 x (1-exp \[LSMLCM-LSMPBO\]).||17.50|-13.59|=0.6895
73906496|NCT01439568|147343759|SUPERIORITY||Hazard Ratio (HR)|1.0608||||0.8072|TWO_SIDED|95.0|0.6598|1.7055|||Logrank Test|||||1.7055|0.6598|0.8072
73906497|NCT03053271|147343765|OTHER|No statistical test was done as only 4 subjects could be enrolled, none met criteria for randomization, and the study was discontinued by the Sponsor.|||||||||||||||||No statistical test was done as only 4 subjects could be enrolled, none met criteria for randomization, and the study was discontinued by the Sponsor.|||
73906498|NCT00580970|147343770|SUPERIORITY_OR_OTHER|||||||0.9138||||||Considering all late rectal toxicities, 38% (20/53) of participants developed physician reported Grade 2 or higher GI toxicity during 2 year follow up. The threshold for significance was p \< 0.05.|t-test, 1 sided|A one sided t-test, with 5% level of significance, and 83% power was used which required 53 subjects.||||||0.9138
73906499|NCT02439879|147343814|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t test|||All data were analyzed using the SPSS v16 statistical package software. To compare categorical variables, the chi2 test was used, and, for continuous variables,the T-test for independent or paired samples was applied.Data are expressed as percent values with 95% confidence intervals (CI) or mean ± SD or mean ± SEM||||< 0.05
73963621|NCT04629950|147462854|SUPERIORITY|||||||0.572||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Maximum Itch. Data represent change values.||||0.572
73963622|NCT04629950|147462855|OTHER|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||||||0.359
73963623|NCT04629950|147462856|OTHER|||||||0.141|||||||Wilcoxon (Mann-Whitney)|||||||0.141
73963624|NCT04629950|147462857|OTHER|||||||0.582|||||||Wilcoxon (Mann-Whitney)|||||||0.582
73963625|NCT04629950|147462858|OTHER|||||||0.713|||||||Wilcoxon (Mann-Whitney)|||||||0.713
73963626|NCT04629950|147462859|OTHER|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||||||0.346
73906500|NCT02787551|147343926|SUPERIORITY||Least square (LS) mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.77|-0.508||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), GLP-1 RA subtype at screening, visits, treatment-by-visit interaction, world region as fixed effects, baseline HbA1c value-by-visit interaction as a covariate. Analysis included all scheduled measurements obtained during 26-week randomized treatment period, including those obtained after IMP discontinuation/introduction of rescue medication.||-0.508|-0.770|<0.0001
74025615|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.22|1.53||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.53|0.22|
74025616|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.38|1.44||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.44|0.38|
74025617|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|0.3|||||TWO_SIDED|95.0|0.1|0.76||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.76|0.10|
74025618|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.25|1.3||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.30|0.25|
74025619|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|0.3|||||TWO_SIDED|95.0|0.11|0.65||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.65|0.11|
74025620|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.81|1.32||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.32|0.81|
74025621|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.56|1.37||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.37|0.56|
74025622|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.51|1.23||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.23|0.51|
74025623|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.17|0.86||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.86|0.17|
74025624|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.64|1.97||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.97|0.64|
74025625|NCT01193335|147604208|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.27|0.97||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.97|0.27|
73963627|NCT04629950|147462860|OTHER|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
73963628|NCT04629950|147462861|OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||Analysis for Average Itch Over the Preceding 3 Days||||0.221
74025626|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.33|2.37||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.37|0.33|
74025627|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.37|3.07||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||3.07|0.37|
74025628|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|0.57|5.36||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||5.36|0.57|
73963629|NCT04629950|147462861|OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Analysis is for the Maximum Itch of the Preceding 7 Days||||0.286
73963630|NCT04629950|147462862|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Analysis for Average Itch Over the Preceding 3 Days||||1
73963631|NCT04629950|147462862|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Analysis is for the Maximum Itch of the Preceding 7 Days||||1
73963632|NCT02088853|147462863|SUPERIORITY|Wilcoxon test|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73963633|NCT02088853|147462864|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73963634|NCT02088853|147462865|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73963635|NCT00396084|147462866|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 4 treatment groups over the 7 days of study drug administration||||<0.001
74025629|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.38|2.07||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.07|0.38|
74025630|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.18|1.21||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.21|0.18|
74025631|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.27|1.53||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.53|0.27|
74025632|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.17|1.15||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.17|
74025633|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.31||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.96|
74025634|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.41|1.14||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.14|0.41|
74025635|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.49|0.92||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.92|0.49|
74025636|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.16|1.03||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.16|
74085097|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.37|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 12.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.37|<0.0001
73963636|NCT00396084|147462866|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.041
73963637|NCT00396084|147462866|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.008
73963638|NCT00396084|147462866|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.012
74025637|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.27|1.48||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.48|0.27|
74025638|NCT01193335|147604209|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.22|0.91||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.91|0.22|
73963639|NCT00396084|147462866|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.01
73963640|NCT00396084|147462866|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.03
73963641|NCT00396084|147462866|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.091
73963642|NCT00396084|147462866|SUPERIORITY_OR_OTHER|||||||0.354||95.0|||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.354
73906501|NCT02787551|147343928|SUPERIORITY||Difference in percentage|36.05|||<|0.0001|TWO_SIDED|95.0|28.11|43.99||Threshold for significance \<=0.05|Cochran-Mantel-Haenszel|||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs GLP-1 Receptor Agonist. Analysis was performed using Cochran-Mantel-Haenszel method method stratified on randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), and randomization strata of GLP-1 receptor agonist subtype at screening. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order (only HbA1c \< 7% was part of testing).||43.99|28.11|<.0001
73906502|NCT02787551|147343930|SUPERIORITY||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.168|<|0.0001|TWO_SIDED|95.0|-2.001|-1.341||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and and baseline FPG value-by visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).||-1.341|-2.001|<0.0001
73906503|NCT02787551|147343932|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.157|<|0.0001|TWO_SIDED|95.0|-1.325|-0.708||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and baseline average SMPG value-by-visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).||-0.708|-1.325|<0.0001
73906504|NCT02787551|147343934|SUPERIORITY||LS Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-3.42|-2.279||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour PPG value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).||-2.279|-3.420|<0.0001
73906505|NCT02787551|147343936|SUPERIORITY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-1.468|-0.508||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 receptor agonist subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).||-0.508|-1.468|<0.0001
73906506|NCT02001181|147343945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.8|STANDARD_ERROR_OF_MEAN|8.48|<|0.0001|TWO_SIDED|80.0|-62.8|-40.8|||Mixed Models Analysis|The mixed model for repeated measures analysis included all the participants in FAS.||||-40.8|-62.8|<0.0001
73906507|NCT01842815|147343950|SUPERIORITY|||||||0.0077||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.0077
73906508|NCT01842815|147343951|SUPERIORITY|||||||0.00012||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.00012
73906509|NCT01842815|147343952|SUPERIORITY|||||||0.0034||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.0034
73906510|NCT00704912|147343990|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.5||||0.06|TWO_SIDED|95.0|1.0|6.6|||Log-binomial model|||||6.6|1.0|0.06
73906511|NCT00704912|147343990|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3||||0.08|TWO_SIDED|95.0|0.9|6.1|||Log-binomial model|||||6.1|0.9|0.08
73906512|NCT00704912|147343990|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.82|TWO_SIDED|95.0|0.5|2.1|||Log-binomial model|||||2.1|0.5|0.82
73906513|NCT00704912|147343991|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.06|TWO_SIDED|95.0|1.0|1.7|||Log-binomial model|||||1.7|1.0|0.06
73963643|NCT00396084|147462870|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 4 treatment groups were compared.||||0.05
73906514|NCT00704912|147343991|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.002|TWO_SIDED|95.0|1.1|1.9|||Log-binomial model|||||1.9|1.1|0.002
73906515|NCT00704912|147343991|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.28|TWO_SIDED|95.0|0.7|1.1|||Log-binomial model|||||1.1|0.7|0.28
73906516|NCT00704912|147343992|SUPERIORITY_OR_OTHER||Difference in Mean Change|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.3|-3.8|||Mixed Models Analysis||Lifestyle vs. OCP|||-3.8|-6.3|<.0001
73906517|NCT00704912|147343992|SUPERIORITY_OR_OTHER||Difference in Mean Change|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.2|-3.7|||Mixed Models Analysis||Combined vs. OCP|||-3.7|-6.2|<.0001
73906518|NCT00704912|147343992|SUPERIORITY_OR_OTHER||Difference in Mean Change|-0.1||||0.92|TWO_SIDED|95.0|-1.3|1.2|||Mixed Models Analysis||Lifestyle vs. Combined|||1.2|-1.3|0.92
73906519|NCT00704912|147343993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.6|TWO_SIDED|95.0|0.6|2.2|||GEE||End of intervention compared to baseline.|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||2.2|0.6|0.60
73906520|NCT00704912|147343993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.001|TWO_SIDED|95.0|1.4|4.3|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||4.3|1.4|0.001
73963644|NCT00396084|147462870|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against gatifloxacin using a simultaneous non-parametric procedure.||||0.01
74085098|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.38|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 13.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.38|<0.0001
73856153|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.08||||0.714|TWO_SIDED|95.0|-0.34|0.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.49|-0.34|0.714
73856154|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.217|TWO_SIDED|95.0|-0.22|0.96|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.96|-0.22|0.217
73856155|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.136|TWO_SIDED|95.0|-0.14|1.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.03|-0.14|0.136
73856156|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.78||||0.01|TWO_SIDED|95.0|0.19|1.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.37|0.19|0.010
73856157|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.006|TWO_SIDED|95.0|0.24|1.41|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.24|0.006
73856158|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.45||||0.031|TWO_SIDED|95.0|-0.87|-0.04|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-0.87|0.031
73906521|NCT00704912|147343993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.18|TWO_SIDED|95.0|0.4|1.2|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||1.2|0.4|0.18
73906522|NCT00704912|147343993|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||GEE|||||||0.08
73856159|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.38||||0.07|TWO_SIDED|95.0|-0.79|0.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.03|-0.79|0.070
73856160|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.822|TWO_SIDED|95.0|-0.46|0.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.37|-0.46|0.822
73856161|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.28||||0.327|TWO_SIDED|95.0|-0.28|0.83|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.83|-0.28|0.327
73856162|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.34||||0.224|TWO_SIDED|95.0|-0.21|0.89|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.89|-0.21|0.224
73906523|NCT00704912|147343993|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||GEE|||||||0.001
73963645|NCT00396084|147462870|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against moxifloxacin using a simultaneous non-parametric procedure.||||0.02
73963646|NCT00396084|147462870|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against levofloxacin using a simultaneous non-parametric procedure.||||0.14
73963647|NCT00396084|147462871|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||Mean values of EBA Days 2 to 7 for the 4 treatment groups were compared.||||0.51
73963648|NCT00396084|147462871|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||The rate of fall in sputum cfu for the 4 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.||||0.16
73963649|NCT00396084|147462871|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for patients in the 3 fluoroquinolone groups were pooled and compared to bactericidal activity of patients in the INH arm.||||0.036
73963650|NCT00396084|147462872|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 3 treatment groups over the 7 days of study drug administration||||<0.001
73856163|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.63||||0.025|TWO_SIDED|95.0|0.08|1.19|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.19|0.08|0.025
73856164|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.7||||0.012|TWO_SIDED|95.0|0.15|1.25|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.25|0.15|0.012
73906524|NCT00704912|147343993|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||GEE|||||||0.22
73906525|NCT02349061|147344005|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0057|TWO_SIDED|95.0|1.41|7.63|||Regression, Logistic|||||7.63|1.41|0.0057
73906526|NCT02349061|147344006|SUPERIORITY||Least Squares (LS) Mean Difference|-1.36||||0.0929|TWO_SIDED|95.0|-2.94|0.23|||Mixed model repeated measures model|||||0.23|-2.94|0.0929
73963651|NCT00396084|147462872|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.023
74025639|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.33|5.99||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.99|-6.33|
73906527|NCT02349061|147344007|SUPERIORITY||LS Means Difference|-0.383||||0.3944|TWO_SIDED|95.0|-1.271|0.506|||Mixed model repeated measures model|||||0.506|-1.271|0.3944
73906528|NCT02349061|147344008|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9939|TWO_SIDED|95.0|0.43|2.34|||Regression, Logistic|||||2.34|0.43|0.9939
73906529|NCT02349061|147344009|SUPERIORITY||LS Means Difference|-2.17||||0.1032|TWO_SIDED|95.0|-4.78|0.45|||Mixed model repeated measures model|||||0.45|-4.78|0.1032
73906530|NCT03347188|147344026|SUPERIORITY||LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.11||0.1876|TWO_SIDED|95.0|-0.73|3.67||Threshold for significance at 0.05 level.|ANCOVA|||||3.67|-0.73|0.1876
73906531|NCT02186873|147344061|SUPERIORITY_OR_OTHER||Difference in Percentage|47.1|||<|0.001|TWO_SIDED|95.0|35.18|58.99|||Cochran-Mantel-Haenszel|||||58.99|35.18|<0.001
73963652|NCT00396084|147462872|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.018
73963653|NCT00396084|147462872|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.03
74025640|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|-4.89|||||TWO_SIDED|95.0|-16.87|5.39||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.39|-16.87|
74025641|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|-6.85|||||TWO_SIDED|95.0|-24.28|10.67||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.67|-24.28|
73906532|NCT01051466|147344079|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||The significance level was 0.05 for a 2-sided test.|Mixed Models Analysis|||||||0.457
73906533|NCT01051466|147344080|SUPERIORITY_OR_OTHER|||||||0.627||||||The p-value is for change from baseline activation (BOLD response) in the anterior cingulate.|Mixed Models Analysis|||||||0.627
73906534|NCT01051466|147344080|SUPERIORITY_OR_OTHER|||||||0.338||||||The p-value is for change from baseline activation (BOLD response) in the left amygdala.|Mixed Models Analysis|||||||0.338
73906535|NCT01051466|147344080|SUPERIORITY_OR_OTHER|||||||0.518||||||The p-value is for change from baseline activation (BOLD response) in the right amygdala.|Mixed Models Analysis|||||||0.518
73906536|NCT01051466|147344081|SUPERIORITY_OR_OTHER|||||||0.03||||||The p-value is for change from baseline volume in the subgenual anterior cingulate.|Mixed Models Analysis|||||||0.030
73906537|NCT01051466|147344081|SUPERIORITY_OR_OTHER|||||||0.208||||||The p-value is for change from baseline volume in the left amygdalae.|Mixed Models Analysis|||||||0.208
73906538|NCT01051466|147344081|SUPERIORITY_OR_OTHER|||||||0.031||||||The p-value is for change from baseline volume in the right amygdalae.|Mixed Models Analysis|||||||0.031
73906539|NCT01051466|147344081|SUPERIORITY_OR_OTHER|||||||0.35||||||The p-value is for change from baseline volume in the left hippocampus.|Mixed Models Analysis|||||||0.350
73906540|NCT01051466|147344081|SUPERIORITY_OR_OTHER|||||||0.191||||||The p-value is for change from baseline volume in the right hippocampus.|Mixed Models Analysis|||||||0.191
74025642|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|3.03|||||TWO_SIDED|95.0|-3.68|10.57||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.57|-3.68|
73906541|NCT01051466|147344082|SUPERIORITY_OR_OTHER|||||||0.174||||||The p-value is for Gsα translocation in RBCs at Week 1.|Mixed Models Analysis|||||||0.174
73906542|NCT01051466|147344082|SUPERIORITY_OR_OTHER|||||||0.488||||||The p-value is for Gsα translocation in RBCs at Week 8.|Mixed Models Analysis|||||||0.488
73906543|NCT01051466|147344082|SUPERIORITY_OR_OTHER|||||||0.48||||||The p-value is for Gsα translocation in RBCs at Week 12.|Mixed Models Analysis|||||||0.480
73906544|NCT01051466|147344082|SUPERIORITY_OR_OTHER|||||||0.925||||||The p-value is for Gsα translocation in platelets at Week 1.|Mixed Models Analysis|||||||0.925
73906545|NCT01051466|147344082|SUPERIORITY_OR_OTHER|||||||0.697||||||The p-value is for Gsα translocation in platelets at Week 8.|Mixed Models Analysis|||||||0.697
73906546|NCT01051466|147344082|SUPERIORITY_OR_OTHER|||||||0.276||||||The p-value is for Gsα translocation in platelets at Week 12.|Mixed Models Analysis|||||||0.276
73906547|NCT01051466|147344084|SUPERIORITY_OR_OTHER|||||||0.904||||||The p-value is for change from baseline BDNF.|Mixed Models Analysis|||||||0.904
73906548|NCT01051466|147344084|SUPERIORITY_OR_OTHER|||||||0.819||||||The p-value is for change from baseline proBDNF.|Mixed Models Analysis|||||||0.819
73906549|NCT01051466|147344085|SUPERIORITY_OR_OTHER|||||||0.273||||||The p-value is for change from baseline trkB.|Mixed Models Analysis|||||||0.273
73906550|NCT01051466|147344086|SUPERIORITY_OR_OTHER|||||||0.797||||||The p-value is for change from baseline cytokine TNFα.|Mixed Models Analysis|||||||0.797
73906551|NCT01051466|147344086|SUPERIORITY_OR_OTHER|||||||0.269||||||The p-value is for change from baseline cytokine IL-1.|Mixed Models Analysis|||||||0.269
73906552|NCT01051466|147344086|SUPERIORITY_OR_OTHER|||||||0.925||||||The p-value is for change from baseline cytokine IL-6.|Mixed Models Analysis|||||||0.925
73963654|NCT00396084|147462872|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.012
73963655|NCT00396084|147462872|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.003
73906553|NCT00137631|147344114|SUPERIORITY_OR_OTHER||Rate Ratio|0.58|||<|0.05||95.0|0.33|1.01|||negative binomial regression|||||1.01|0.33|< 0.05
73906554|NCT00137631|147344115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|||<|0.05||95.0|1.05|1.68|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||1.68|1.05|< 0.05
73906555|NCT00137631|147344116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17|||<|0.05||95.0|0.69|1.98|||Mixed Models Analysis|||||1.98|0.69|< 0.05
73906556|NCT00137631|147344117|SUPERIORITY_OR_OTHER||Rate Ratio|0.49|||<|0.05||95.0|0.28|0.87|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||0.87|0.28|< 0.05
73906557|NCT00137631|147344118|SUPERIORITY_OR_OTHER||Rate Ratio|0.8|||<|0.05||95.0|0.42|1.53|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||1.53|0.42|< 0.05
73906558|NCT00351000|147344122|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||t-test, 2 sided|||||||0.956
73906559|NCT00351000|147344123|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||t-test, 2 sided|||||||0.988
73906560|NCT01675427|147344195|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.0018
73906561|NCT01675427|147344195|SUPERIORITY_OR_OTHER|||||||0.2289|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.2289
73906562|NCT01675427|147344195|SUPERIORITY_OR_OTHER|||||||0.1112|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.1112
73963656|NCT00396084|147462872|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.003
73963657|NCT00396084|147462872|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.004
73963658|NCT00396084|147462873|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 3 treatments groups were compared.||||<0.01
73963659|NCT00396084|147462873|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against Linezolid once daily using a simultaneous non-parametric procedure.||||<0.01
74025643|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.57|5.88||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.88|-6.57|
73906563|NCT01675427|147344195|SUPERIORITY_OR_OTHER|||||||0.4681|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.4681
73906564|NCT01675427|147344195|SUPERIORITY_OR_OTHER|||||||0.4828|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.4828
73906565|NCT01675427|147344195|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.2702
73906566|NCT01675427|147344196|SUPERIORITY_OR_OTHER|||||||0.4133|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.4133
73906567|NCT01675427|147344196|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.4400
73906568|NCT01675427|147344196|SUPERIORITY_OR_OTHER|||||||0.8597|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.8597
73906569|NCT01675427|147344196|SUPERIORITY_OR_OTHER|||||||0.3975|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.3975
73906570|NCT01675427|147344196|SUPERIORITY_OR_OTHER|||||||0.1781|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.1781
73906571|NCT01675427|147344196|SUPERIORITY_OR_OTHER|||||||0.3159|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.3159
73906572|NCT01675427|147344197|SUPERIORITY_OR_OTHER|||||||0.0126|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.0126
73906573|NCT01675427|147344197|SUPERIORITY_OR_OTHER|||||||0.7174|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.7174
73906574|NCT01675427|147344197|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.1380
74025644|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|3.45|||||TWO_SIDED|95.0|-3.32|11.91||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.91|-3.32|
74025645|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|1.52|||||TWO_SIDED|95.0|-6.73|9.94||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.94|-6.73|
74025646|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Perecent Difference|-10.82|||||TWO_SIDED|95.0|-25.51|4.34||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.34|-25.51|
73906575|NCT01675427|147344197|SUPERIORITY_OR_OTHER|||||||0.6258|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.6258
73906576|NCT01675427|147344197|SUPERIORITY_OR_OTHER|||||||0.5751|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.5751
73963660|NCT00396084|147462873|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Mean EBA 0-2 of INH was compared to pooled Linezolid once daily and Linezolid twice daily results.||||<0.01
74085099|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.41|-0.51||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 14.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.51|-1.41|<0.0001
74085100|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.53|-0.63||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 15.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.63|-1.53|<0.0001
73906577|NCT01675427|147344197|SUPERIORITY_OR_OTHER|||||||0.1681|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.1681
73906578|NCT01675427|147344198|SUPERIORITY_OR_OTHER|||||||0.2693|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.2693
73906579|NCT01675427|147344198|SUPERIORITY_OR_OTHER|||||||0.324|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.3240
73906580|NCT01675427|147344198|SUPERIORITY_OR_OTHER|||||||0.7006|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7006
73906581|NCT01675427|147344198|SUPERIORITY_OR_OTHER|||||||0.0403|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.0403
73906582|NCT01675427|147344198|SUPERIORITY_OR_OTHER|||||||0.1075|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.1075
73906583|NCT01675427|147344198|SUPERIORITY_OR_OTHER|||||||0.3295|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.3295
73906584|NCT01675427|147344199|SUPERIORITY_OR_OTHER|||||||0.9859|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.9859
73906585|NCT01675427|147344199|SUPERIORITY_OR_OTHER|||||||0.7055|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.7055
73906586|NCT01675427|147344199|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0920
73963661|NCT00396084|147462876|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|||Mean values EBA Days 2-7 for the 3 treatment groups were compared.||||0.25
73963662|NCT00396084|147462876|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||The rate of fall in sputum cfu for the 3 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.||||0.42
73906587|NCT01675427|147344199|SUPERIORITY_OR_OTHER|||||||0.0781|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0781
73963663|NCT00396084|147462876|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for INH was compared to that of the pooled linezolid arms.||||0.14
73906588|NCT01675427|147344199|SUPERIORITY_OR_OTHER|||||||0.4795|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4795
73906589|NCT01675427|147344199|SUPERIORITY_OR_OTHER|||||||0.3069|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.3069
73906590|NCT01675427|147344200|SUPERIORITY_OR_OTHER|||||||0.5216|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.5216
73906591|NCT01675427|147344200|SUPERIORITY_OR_OTHER|||||||0.3419|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.3419
73906592|NCT01675427|147344200|SUPERIORITY_OR_OTHER|||||||0.7586|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.7586
73906593|NCT01675427|147344200|SUPERIORITY_OR_OTHER|||||||0.1351|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1351
73906594|NCT01675427|147344200|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2386
73906595|NCT01675427|147344200|SUPERIORITY_OR_OTHER|||||||0.3921|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.3921
73906596|NCT01675427|147344201|SUPERIORITY_OR_OTHER|||||||0.8537|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8537
73963664|NCT02708108|147462888|OTHER|Multivariable analysis|Odds Ratio (OR)|0.3||||0.02|TWO_SIDED|95.0|0.09|0.92||Reported as 1-sided p-value.|Regression, Logistic||Multivariable model includes age, BMI category, cytogenetic risk, ethnicity, sex|||0.92|0.09|0.02
73963665|NCT00891436|147462892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|>|0.1||95.0|||||t-test, 2 sided|||paired t-test was used for the data analysis||||>0.1
73963666|NCT00891436|147462892|NON_INFERIORITY_OR_EQUIVALENCE|t-test showed no different between the 2 groups.|Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|>|0.1||95.0|||||t-test, 2 sided|||||||>0.1
73963667|NCT01381406|147462906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.772||||0.007|TWO_SIDED|95.0|0.641|0.93||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Any COPD Exacerbation|Regression, Logistic|||||0.930|0.641|0.007
73963668|NCT01381406|147462906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.622||||0.146|TWO_SIDED|95.0|0.328|1.18||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Severe COPD Exacerbations|Regression, Logistic|||||1.180|0.328|0.146
73963669|NCT01381406|147462906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.763||||0.013|TWO_SIDED|95.0|0.646|0.949||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Moderate COPD Exacerbations|Regression, Logistic|||||0.949|0.646|0.013
73963670|NCT03447249|147462909|SUPERIORITY||Least Squares (LS) Mean Difference|14.0|||<|0.0001|TWO_SIDED|95.0|12.4|15.7|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.||15.7|12.4|<0.0001
73906597|NCT01675427|147344201|SUPERIORITY_OR_OTHER|||||||0.0763|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0763
73906598|NCT01675427|147344201|SUPERIORITY_OR_OTHER|||||||0.2432|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2432
73906599|NCT01675427|147344201|SUPERIORITY_OR_OTHER|||||||0.4247|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4247
73963671|NCT03447249|147462910|SUPERIORITY||LS Mean Difference|14.2|||<|0.0001|TWO_SIDED|95.0|12.6|15.7|||Mixed-effects model for repeated measure|||||15.7|12.6|<0.0001
73906600|NCT01675427|147344201|SUPERIORITY_OR_OTHER|||||||0.4884|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4884
73906601|NCT01675427|147344201|SUPERIORITY_OR_OTHER|||||||0.6119|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.6119
73963672|NCT03447249|147462911|SUPERIORITY||Rate ratio|0.14|||<|0.0001|TWO_SIDED|95.0|0.09|0.24|||Negative binomial regression model|||||0.24|0.09|<0.0001
73963673|NCT03447249|147462912|SUPERIORITY||LS Mean Difference|-44.6|||<|0.0001|TWO_SIDED|95.0|-47.2|-41.9|||Mixed-effects model for repeated measure|||||-41.9|-47.2|<0.0001
73906602|NCT01675427|147344202|SUPERIORITY_OR_OTHER|||||||0.2416|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.2416
73963674|NCT03447249|147462913|SUPERIORITY||LS Mean Difference|20.1|||<|0.0001|TWO_SIDED|95.0|17.2|23.0|||Mixed-effects model for repeated measure|||||23.0|17.2|<0.0001
73963675|NCT03447249|147462914|SUPERIORITY||LS Mean Difference|1.11|||<|0.0001|TWO_SIDED|95.0|0.91|1.31|||Mixed-effects model for repeated measure|||||1.31|0.91|<0.0001
73963676|NCT03447249|147462915|SUPERIORITY||LS Mean Difference|-43.4|||<|0.0001|TWO_SIDED|95.0|-46.3|-40.5|||Mixed-effects model for repeated measure|||||-40.5|-46.3|<0.0001
73963677|NCT03447249|147462916|SUPERIORITY||LS Mean Difference|17.9|||<|0.0001|TWO_SIDED|95.0|14.5|21.3|||Mixed-effects model for repeated measure|||||21.3|14.5|<0.0001
73963678|NCT03447249|147462918|SUPERIORITY||LS Mean Difference|0.39|||||TWO_SIDED|95.0|0.24|0.54||||||||0.54|0.24|
73963679|NCT03447249|147462919|SUPERIORITY||LS Mean Difference|3.2|||||TWO_SIDED|95.0|2.7|3.8||||||||3.8|2.7|
73963680|NCT00440011|147462950|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|||||||0.024
73963681|NCT01803555|147462954|NON_INFERIORITY|The noninferiority of BF Spiromax to Symbicort Turbohaler was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -15 L/min.|Least Square (LS) mean difference|-2.957||||0.3387|TWO_SIDED|95.0|-9.02|3.11|||Mixed Models Analysis|Analysis included effects due to baseline weekly average of daily trough AM PEF, gender, age, treatment, time, and treatment-by-time interaction.||||3.11|-9.02|0.3387
73963682|NCT01551355|147462959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED|95.0|1.64|6.16|||t-test, 2 sided|The intervention was evaluated using generalized estimating equation models, controlling for cluster effect, sex, age, weight, and education level.||||6.16|1.64|<.001
73963683|NCT01551355|147462960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||<|0.001|TWO_SIDED|95.0|2.03|6.12|||t-test, 2 sided|||||6.12|2.03|<.001
74025647|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|4.65|||||TWO_SIDED|95.0|0.04|11.48||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.48|0.04|
73906603|NCT01675427|147344202|SUPERIORITY_OR_OTHER|||||||0.2671|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2671
73906604|NCT01675427|147344202|SUPERIORITY_OR_OTHER|||||||0.4619|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.4619
73906605|NCT01675427|147344202|SUPERIORITY_OR_OTHER|||||||0.8364|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.8364
73963684|NCT01551355|147462961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.36|||=|0.06|TWO_SIDED|95.0|-0.29|11.01|||t-test, 2 sided|||||11.01|-0.29|=.06
73971127|NCT03221426|147482733|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.00589|TWO_SIDED|95.0|0.67|0.95||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||0.95|0.67|0.00589
73971128|NCT03257410|147482766|SUPERIORITY||Mean Difference (Final Values)|14.828|||||TWO_SIDED|95.0|10.501|19.156|||||Method=ANCOVA|If the lower bound of the two-sided 95% confidence interval around the difference between Theranova 400 and Elisio-17H is \> 0 then superiority will be demonstrated.||19.156|10.501|
73906606|NCT01675427|147344202|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2386
73906607|NCT01675427|147344202|SUPERIORITY_OR_OTHER|||||||0.2887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2887
73906608|NCT01675427|147344203|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.0049
73906609|NCT01675427|147344204|SUPERIORITY_OR_OTHER|||||||0.5651|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.5651
73906610|NCT01675427|147344205|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.0420
73906611|NCT01675427|147344206|SUPERIORITY_OR_OTHER|||||||0.4545|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.4545
73906612|NCT01675427|147344207|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
73906613|NCT01675427|147344208|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
73906614|NCT01675427|147344209|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
73906615|NCT01675427|147344210|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
73906616|NCT01675427|147344211|SUPERIORITY_OR_OTHER|||||||0.5468|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.5468
73906617|NCT01675427|147344212|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0020
73906618|NCT01675427|147344213|SUPERIORITY_OR_OTHER|||||||0.1623|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.1623
73906619|NCT01675427|147344214|SUPERIORITY_OR_OTHER|||||||0.0663|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0663
73906620|NCT01675427|147344215|SUPERIORITY_OR_OTHER|||||||0.2617|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.2617
73906621|NCT01675427|147344216|SUPERIORITY_OR_OTHER|||||||0.0526|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0526
73906622|NCT01675427|147344217|SUPERIORITY_OR_OTHER|||||||0.7918|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.7918
73963685|NCT04922021|147462970|SUPERIORITY|Two-sided hypotheses were tested based on the pre-specified primary analysis for the primary estimand. The primary estimand used a hypothetical strategy evaluating the treatment difference as if all subjects adhered to the treatment regimen, i.e. they did not discontinue IMP permanently, did not initiate rescue treatment, or did not have more than one missed treatment dose related to COVID-19.|Mean Difference (Net)|-11.8||||0.003|TWO_SIDED|95.0|-19.6|-4.1||The type I error rate of the two-sided hypothesis test was controlled at the 5% significance level.|ANCOVA|ANCOVA model: Change in EASI = Treatment + Region + Baseline EASI. Missing values and data 'treated as missing' were imputed using MI assuming MAR.|Estimates of difference in LS-means and associated standard errors from the analyses were combined using Rubin's rule to provide the overall pooled estimate and associated standard error. LS-means was estimated using the observed margins for the FAS.|||-4.1|-19.6|0.003
74025648|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|-16.06|||||TWO_SIDED|95.0|-29.15|-2.6||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.60|-29.15|
73906623|NCT01675427|147344218|SUPERIORITY_OR_OTHER|||||||0.0842|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0842
73906624|NCT01675427|147344219|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
73906625|NCT01675427|147344220|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
73906626|NCT01675427|147344221|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
73906627|NCT01675427|147344222|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
73906628|NCT01675427|147344223|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
73906629|NCT01675427|147344223|SUPERIORITY_OR_OTHER|||||||0.2887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2887
73906630|NCT01675427|147344223|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
73906631|NCT01675427|147344223|SUPERIORITY_OR_OTHER|||||||0.1634|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1634
73906632|NCT01675427|147344223|SUPERIORITY_OR_OTHER|||||||0.8956|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.8956
73906633|NCT01675427|147344223|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
73906634|NCT01675427|147344224|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
73906635|NCT01675427|147344224|SUPERIORITY_OR_OTHER|||||||0.0145|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0145
73906636|NCT01675427|147344224|SUPERIORITY_OR_OTHER|||||||0.1027|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1027
73906637|NCT01675427|147344224|SUPERIORITY_OR_OTHER|||||||0.5998|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5998
73906638|NCT01675427|147344224|SUPERIORITY_OR_OTHER|||||||0.2935|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2935
73906639|NCT01675427|147344224|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0039
73906640|NCT01675427|147344225|SUPERIORITY_OR_OTHER|||||||0.1981|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.1981
73906641|NCT01675427|147344225|SUPERIORITY_OR_OTHER|||||||0.1616|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1616
73906642|NCT01675427|147344225|SUPERIORITY_OR_OTHER|||||||0.1192|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1192
73906643|NCT01675427|147344225|SUPERIORITY_OR_OTHER|||||||0.4485|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4485
73906644|NCT01675427|147344225|SUPERIORITY_OR_OTHER|||||||0.1525|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1525
73906645|NCT01675427|147344225|SUPERIORITY_OR_OTHER|||||||0.7262|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.7262
73963686|NCT01285999|147462993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.05|TWO_SIDED|95.0|-0.37|-0.21||p-value has not been adjusted.|t-test, 2 sided|No adjustment.||H0: μt - μc = 0 H1: μt - μc ≠ 0 where μt and μc are the mean 9-month in-stent late loss values for the subjects in the PROMUS Element test and TAXUS Liberté control treatment groups, respectively.||-0.21|-0.37|0.05
73963687|NCT04188379|147463056|SUPERIORITY||Odds Ratio (OR)|4.884||||0.0316|TWO_SIDED|95.0|1.007|43.591|||Cochran-Mantel-Haenszel|||||43.591|1.007|0.0316
73963688|NCT04188379|147463057|SUPERIORITY||Median Difference (Net)|1.0||||0.0009|TWO_SIDED|95.0|0.0|4.0|||Wilcoxon (Mann-Whitney)|||||4.000|0.000|0.0009
73963689|NCT04188379|147463058|SUPERIORITY||Odds Ratio (OR)|5.224||||0.0108|TWO_SIDED|95.0|1.268|26.268|||Cochran-Mantel-Haenszel|||||26.268|1.268|0.0108
73906646|NCT01675427|147344226|SUPERIORITY_OR_OTHER|||||||0.0911|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0911
73906647|NCT01675427|147344226|SUPERIORITY_OR_OTHER|||||||0.4674|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.4674
73906648|NCT01675427|147344226|SUPERIORITY_OR_OTHER|||||||0.1604|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1604
73906649|NCT01675427|147344226|SUPERIORITY_OR_OTHER|||||||0.5937|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5937
73906650|NCT01675427|147344226|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3830
73963690|NCT04188379|147463059|SUPERIORITY||Rate Ratio|0.958||||0.8287|TWO_SIDED|95.0|0.651|1.41|||Wald Test|||||1.41|0.651|0.8287
73963691|NCT04188379|147463060|SUPERIORITY||Odds Ratio (OR)|4.354||||0.0265|TWO_SIDED|95.0|1.048|22.865|||Cochran-Mantel-Haenszel|||||22.865|1.0480|0.0265
73906651|NCT01675427|147344226|SUPERIORITY_OR_OTHER|||||||0.0507|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0507
73906652|NCT01675427|147344227|SUPERIORITY_OR_OTHER|||||||0.8686|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8686
73906653|NCT01675427|147344227|SUPERIORITY_OR_OTHER|||||||0.3135|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.3135
73906654|NCT01675427|147344227|SUPERIORITY_OR_OTHER|||||||0.0578|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0578
73906655|NCT01675427|147344227|SUPERIORITY_OR_OTHER|||||||0.5833|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5833
73906656|NCT01675427|147344227|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1610
73906657|NCT01675427|147344227|SUPERIORITY_OR_OTHER|||||||0.2925|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2925
73906658|NCT01675427|147344228|SUPERIORITY_OR_OTHER|||||||0.3709|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.3709
73963692|NCT02566902|147463074|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
73963693|NCT02566902|147463075|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
73963694|NCT02566902|147463076|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
73963695|NCT02566902|147463077|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
73963696|NCT02566902|147463078|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||||||0.99
73963697|NCT02566902|147463079|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73963698|NCT05773313|147463092|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Food Insecurity||||>0.999
73963699|NCT05773313|147463092|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Financial Insecurity||||0.250
73963700|NCT05773313|147463092|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Social Isolation||||>0.999
73963701|NCT05773313|147463092|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Physical Inactivity||||>0.999
73963702|NCT05773313|147463092|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Disability||||>0.999
73963703|NCT05773313|147463093|SUPERIORITY|||||||0.461|||||||Wilcoxon (Mann-Whitney)|||||||0.461
73963704|NCT05773313|147463094|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
73963705|NCT05773313|147463095|SUPERIORITY|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
73963706|NCT05773313|147463096|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.080
73963707|NCT02748317|147463097|OTHER|1 group t-test no comparison group|||||=|0.219||||||P-value is not adjusted|t-test, 2 sided|||||||=0.219
73856165|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.43||||0.03|TWO_SIDED|95.0|-0.81|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-0.81|0.030
73856166|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.36||||0.064|TWO_SIDED|95.0|-0.75|0.02|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.02|-0.75|0.064
73856167|NCT01559259|147258981|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.721|TWO_SIDED|95.0|-0.46|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-0.46|0.721
74025649|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|2.27|||||TWO_SIDED|95.0|-1.96|7.97||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.97|-1.96|
73856168|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22||||0.033|TWO_SIDED|95.0|0.02|0.42|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|0.02|0.033
73856169|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.224|TWO_SIDED|95.0|-0.08|0.33|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.33|-0.08|0.224
73856170|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.024|TWO_SIDED|95.0|0.03|0.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.44|0.03|0.024
73856171|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.501|TWO_SIDED|95.0|-0.13|0.27|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.27|-0.13|0.501
73856172|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.036|TWO_SIDED|95.0|0.01|0.29|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.29|0.01|0.036
73856173|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.06||||0.435|TWO_SIDED|95.0|-0.08|0.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-0.08|0.435
73856174|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.023|TWO_SIDED|95.0|0.02|0.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|0.02|0.023
73856175|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.52|1.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.12|0.52|<0.001
73856176|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.67|||<|0.001|TWO_SIDED|95.0|0.37|0.97|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.97|0.37|<0.001
73856177|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74|||<|0.001|TWO_SIDED|95.0|0.45|1.04|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.04|0.45|<0.001
73856178|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.003|TWO_SIDED|95.0|0.16|0.75|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|0.16|0.003
73856179|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37|||<|0.001|TWO_SIDED|95.0|0.16|0.58|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.58|0.16|<0.001
73856180|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.039|TWO_SIDED|95.0|0.01|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|0.01|0.039
73856181|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.006|TWO_SIDED|95.0|0.08|0.5|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|0.08|0.006
73856182|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.33|||<|0.001|TWO_SIDED|95.0|1.01|1.65|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.65|1.01|<0.001
73856183|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.85|1.49|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.49|0.85|<0.001
73856184|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35|||<|0.001|TWO_SIDED|95.0|1.03|1.67|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.67|1.03|<0.001
73856185|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.04|||<|0.001|TWO_SIDED|95.0|0.72|1.36|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.36|0.72|<0.001
73856186|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.011|TWO_SIDED|95.0|0.07|0.52|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|0.07|0.011
73856187|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.267|TWO_SIDED|95.0|-0.1|0.35|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.10|0.267
73856188|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.007|TWO_SIDED|95.0|0.09|0.53|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|0.09|0.007
73856189|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57|||<|0.001|TWO_SIDED|95.0|1.24|1.89|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.89|1.24|<0.001
73856190|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.38|||<|0.001|TWO_SIDED|95.0|1.06|1.7|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|1.06|<0.001
73856191|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57|||<|0.001|TWO_SIDED|95.0|1.25|1.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.90|1.25|<0.001
73963708|NCT00802464|147463110|OTHER||Fold increase|5.21|||||TWO_SIDED|95.0|3.89|6.98||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.||6.98|3.89|
73963709|NCT00802464|147463110|OTHER||Fold increase|4.02|||||TWO_SIDED|95.0|3.0|5.4||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.||5.4|3|
73856192|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35|||<|0.001|TWO_SIDED|95.0|1.02|1.67|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.67|1.02|<0.001
73856193|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.056|TWO_SIDED|95.0|-0.01|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.01|0.056
73856194|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.759|TWO_SIDED|95.0|-0.19|0.26|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.26|-0.19|0.759
73856195|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.051|TWO_SIDED|95.0|0.0|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.00|0.051
73856196|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.3|1.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|1.30|<0.001
73856197|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.52|||<|0.001|TWO_SIDED|95.0|1.18|1.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.85|1.18|<0.001
73856198|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.71|||<|0.001|TWO_SIDED|95.0|1.37|2.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.05|1.37|<0.001
73856199|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.52|||<|0.001|TWO_SIDED|95.0|1.19|1.86|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|1.19|<0.001
73856200|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.11||||0.342|TWO_SIDED|95.0|-0.12|0.35|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.12|0.342
73856201|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.01||||0.943|TWO_SIDED|95.0|-0.24|0.23|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.24|0.943
73856202|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.18||||0.126|TWO_SIDED|95.0|-0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|-0.05|0.126
73906659|NCT01675427|147344228|SUPERIORITY_OR_OTHER|||||||0.2054|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2054
74025650|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|-2.15|||||TWO_SIDED|95.0|-7.55|2.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||2.10|-7.55|
73906660|NCT01675427|147344228|SUPERIORITY_OR_OTHER|||||||0.8457|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.8457
73906661|NCT01675427|147344228|SUPERIORITY_OR_OTHER|||||||0.3492|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3492
73906662|NCT01675427|147344228|SUPERIORITY_OR_OTHER|||||||0.2846|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2846
73906663|NCT01675427|147344228|SUPERIORITY_OR_OTHER|||||||0.2646|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2646
73906664|NCT01675427|147344229|SUPERIORITY_OR_OTHER|||||||0.5348|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.5348
73906665|NCT01675427|147344229|SUPERIORITY_OR_OTHER|||||||0.5469|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.5469
73906666|NCT01675427|147344229|SUPERIORITY_OR_OTHER|||||||0.0463|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0463
74025651|NCT01193335|147604210|SUPERIORITY_OR_OTHER||Percent Difference|-1.09|||||TWO_SIDED|95.0|-5.96|3.18||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.18|-5.96|
73906667|NCT01675427|147344229|SUPERIORITY_OR_OTHER|||||||0.9393|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.9393
73906668|NCT01675427|147344229|SUPERIORITY_OR_OTHER|||||||0.3404|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3404
73906669|NCT01675427|147344229|SUPERIORITY_OR_OTHER|||||||0.4237|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.4237
73906670|NCT01675427|147344230|SUPERIORITY_OR_OTHER|||||||0.251|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.2510
73906671|NCT01675427|147344230|SUPERIORITY_OR_OTHER|||||||0.2943|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2943
73906672|NCT01675427|147344230|SUPERIORITY_OR_OTHER|||||||0.0478|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0478
73906673|NCT01675427|147344230|SUPERIORITY_OR_OTHER|||||||0.5387|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5387
73906674|NCT01675427|147344230|SUPERIORITY_OR_OTHER|||||||0.3878|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3878
73906675|NCT01675427|147344230|SUPERIORITY_OR_OTHER|||||||0.0748|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0748
73906676|NCT01675427|147344231|SUPERIORITY_OR_OTHER|||||||0.9887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.9887
74025652|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|-9.08|||||TWO_SIDED|95.0|-25.11|7.49||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.49|-25.11|
74025653|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|-5.39|||||TWO_SIDED|95.0|-21.03|10.4||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.40|-21.03|
73906677|NCT01675427|147344231|SUPERIORITY_OR_OTHER|||||||0.5507|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.5507
73906678|NCT01675427|147344231|SUPERIORITY_OR_OTHER|||||||0.0175|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0175
73906679|NCT01675427|147344231|SUPERIORITY_OR_OTHER|||||||0.2246|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.2246
73906680|NCT01675427|147344231|SUPERIORITY_OR_OTHER|||||||0.3519|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3519
73906681|NCT01675427|147344231|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.7140
73906682|NCT01675427|147344232|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8622
73906683|NCT01675427|147344232|SUPERIORITY_OR_OTHER|||||||0.1622|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1622
73906684|NCT01675427|147344232|SUPERIORITY_OR_OTHER|||||||0.2566|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2566
73906685|NCT01675427|147344232|SUPERIORITY_OR_OTHER|||||||0.1574|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1574
73856203|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.27|1.98|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|1.27|<0.001
73856204|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5|||<|0.001|TWO_SIDED|95.0|1.15|1.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|1.15|<0.001
73856205|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.29|2.0|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.00|1.29|<0.001
73856206|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53|||<|0.001|TWO_SIDED|95.0|1.18|1.89|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.89|1.18|<0.001
73856207|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.453|TWO_SIDED|95.0|-0.15|0.34|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-0.15|0.453
73856208|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.816|TWO_SIDED|95.0|-0.28|0.22|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-0.28|0.816
73856209|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.11||||0.384|TWO_SIDED|95.0|-0.14|0.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.36|-0.14|0.384
73856210|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.55|||<|0.001|TWO_SIDED|95.0|1.19|1.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.91|1.19|<0.001
73856211|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|1.10|<0.001
73963710|NCT00802464|147463110|OTHER||Fold increase|1.3|||||TWO_SIDED|95.0|1.07|1.58||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.||1.58|1.07|
73963711|NCT00802464|147463111|OTHER||Fold increase|2.12|||||TWO_SIDED|95.0|1.67|2.69||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.||2.69|1.67|
73963712|NCT00802464|147463111|OTHER||Fold increase|1.63|||||TWO_SIDED|95.0|1.28|2.07||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.||2.07|1.28|
73963713|NCT00802464|147463111|OTHER||Fold increase|1.3|||||TWO_SIDED|95.0|1.09|1.56||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.||1.56|1.09|
73856212|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.61|||<|0.001|TWO_SIDED|95.0|1.25|1.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.97|1.25|<0.001
73856213|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|1.10|<0.001
73856214|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.09||||0.483|TWO_SIDED|95.0|-0.16|0.34|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-0.16|0.483
73856215|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.991|TWO_SIDED|95.0|-0.25|0.25|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.25|-0.25|0.991
73856216|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.228|TWO_SIDED|95.0|-0.1|0.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.41|-0.10|0.228
73856217|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.48|||<|0.001|TWO_SIDED|95.0|1.1|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.85|1.10|<0.001
73856218|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32|||<|0.001|TWO_SIDED|95.0|0.94|1.69|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.69|0.94|<0.001
73856219|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53|||<|0.001|TWO_SIDED|95.0|1.15|1.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.90|1.15|<0.001
73856220|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.4|||<|0.001|TWO_SIDED|95.0|1.03|1.78|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|1.03|<0.001
73856221|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.587|TWO_SIDED|95.0|-0.19|0.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.33|-0.19|0.587
73856222|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.09||||0.517|TWO_SIDED|95.0|-0.35|0.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.17|-0.35|0.517
73856223|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.12||||0.36|TWO_SIDED|95.0|-0.14|0.38|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-0.14|0.360
73856224|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.81|1.6|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.60|0.81|<0.001
73856225|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.78|1.57|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.57|0.78|<0.001
73856226|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.36|||<|0.001|TWO_SIDED|95.0|0.97|1.76|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.76|0.97|<0.001
73856227|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.77|1.56|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.77|<0.001
73856228|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03||||0.811|TWO_SIDED|95.0|-0.24|0.31|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.24|0.811
73856229|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.977|TWO_SIDED|95.0|-0.27|0.28|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.28|-0.27|0.977
73963714|NCT00802464|147463112|OTHER||Fold increase|4.72|||||TWO_SIDED|95.0|3.81|5.85||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.||5.85|3.81|
73963715|NCT00802464|147463112|OTHER||Fold increase|3.36|||||TWO_SIDED|95.0|2.72|4.17||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.||4.17|2.72|
73856230|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.164|TWO_SIDED|95.0|-0.08|0.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|-0.08|0.164
73856231|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03|||<|0.001|TWO_SIDED|95.0|0.63|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.43|0.63|<0.001
73856232|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.4|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.40|0.60|<0.001
73856233|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.15|||<|0.001|TWO_SIDED|95.0|0.75|1.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.75|<0.001
73856234|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.06|||<|0.001|TWO_SIDED|95.0|0.66|1.46|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.46|0.66|<0.001
73856235|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.846|TWO_SIDED|95.0|-0.31|0.25|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.25|-0.31|0.846
73856236|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.702|TWO_SIDED|95.0|-0.33|0.23|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.33|0.702
73856237|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.496|TWO_SIDED|95.0|-0.18|0.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-0.18|0.496
73856238|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.41|1.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.22|0.41|<0.001
73856239|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.4|1.21|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.21|0.40|<0.001
73856240|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.86|||<|0.001|TWO_SIDED|95.0|0.46|1.26|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.26|0.46|<0.001
73963716|NCT00802464|147463112|OTHER||Fold increase|1.4|||||TWO_SIDED|95.0|1.17|1.68||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.||1.68|1.17|
73906686|NCT01675427|147344232|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5784
73906687|NCT01675427|147344232|SUPERIORITY_OR_OTHER|||||||0.6603|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.6603
73906688|NCT01675427|147344233|SUPERIORITY_OR_OTHER|||||||0.0605|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0605
73906689|NCT01675427|147344233|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0899
73906690|NCT01675427|147344233|SUPERIORITY_OR_OTHER|||||||0.0634|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0634
73906691|NCT01675427|147344233|SUPERIORITY_OR_OTHER|||||||0.6165|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.6165
73906692|NCT01675427|147344233|SUPERIORITY_OR_OTHER|||||||0.1649|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1649
73906693|NCT01675427|147344233|SUPERIORITY_OR_OTHER|||||||0.9159|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.9159
73963717|NCT00802464|147463113|OTHER||Fold increase|3.21|||||TWO_SIDED|36.0|2.64|3.9||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.||3.9|2.64|
73963718|NCT00802464|147463113|OTHER||Fold increase|2.44|||||TWO_SIDED|95.0|2.02|2.97||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.||2.97|2.02|
73963719|NCT00802464|147463113|OTHER||Fold increase|1.31|||||TWO_SIDED|95.0|1.12|1.54||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.||1.54|1.12|
73856241|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.92|||<|0.001|TWO_SIDED|95.0|0.52|1.33|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.33|0.52|<0.001
73856242|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.441|TWO_SIDED|95.0|-0.39|0.17|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.17|-0.39|0.441
73906694|NCT01675427|147344234|SUPERIORITY_OR_OTHER|||||||0.7454|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.7454
73906695|NCT01675427|147344234|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0016
73906696|NCT01675427|147344234|SUPERIORITY_OR_OTHER|||||||0.5261|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5261
73906697|NCT01675427|147344234|SUPERIORITY_OR_OTHER|||||||0.3422|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3422
73906698|NCT01675427|147344234|SUPERIORITY_OR_OTHER|||||||0.9026|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.9026
73906699|NCT01675427|147344235|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0017
73906700|NCT01675427|147344235|SUPERIORITY_OR_OTHER|||||||0.8864|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.8864
73906701|NCT01675427|147344235|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0291
73963720|NCT00402246|147463130|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|17.4|||<|0.001||95.0||||The a priori threshold for significance was an alpha level of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that the time from a clinical event to a clinical decision for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||||<0.001
73906702|NCT01675427|147344235|SUPERIORITY_OR_OTHER|||||||0.5472|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5472
73906703|NCT01675427|147344235|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||1.000
73906704|NCT01675427|147344235|SUPERIORITY_OR_OTHER|||||||0.1148|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.1148
73906705|NCT01675427|147344236|SUPERIORITY_OR_OTHER|||||||0.4207|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.4207
73906706|NCT01675427|147344236|SUPERIORITY_OR_OTHER|||||||0.0566|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0566
73906707|NCT01675427|147344236|SUPERIORITY_OR_OTHER|||||||0.1211|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1211
73906708|NCT01675427|147344236|SUPERIORITY_OR_OTHER|||||||0.3772|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3772
73906709|NCT01675427|147344236|SUPERIORITY_OR_OTHER|||||||0.4023|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.4023
74025654|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|6.53|||||TWO_SIDED|95.0|-7.16|21.16||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||21.16|-7.16|
73856243|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.12||||0.408|TWO_SIDED|95.0|-0.4|0.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.16|-0.40|0.408
73856244|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.06||||0.652|TWO_SIDED|95.0|-0.35|0.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-0.35|0.652
73856245|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.61||||0.003|TWO_SIDED|95.0|0.21|1.02|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|0.21|0.003
73856246|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.007|TWO_SIDED|95.0|0.15|0.95|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|0.15|0.007
73856247|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.69|||<|0.001|TWO_SIDED|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.29|<0.001
73856248|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.7|||<|0.001|TWO_SIDED|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.29|<0.001
73856249|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.08||||0.567|TWO_SIDED|95.0|-0.36|0.2|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-0.36|0.567
73856250|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.315|TWO_SIDED|95.0|-0.42|0.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.14|-0.42|0.315
73906710|NCT01675427|147344237|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
73906711|NCT01675427|147344237|SUPERIORITY_OR_OTHER|||||||0.2132|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2132
73856251|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.997|TWO_SIDED|95.0|-0.28|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.28|-0.28|0.997
73856252|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.056|TWO_SIDED|95.0|-0.01|0.77|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.77|-0.01|0.056
73856253|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.047|TWO_SIDED|95.0|0.01|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|0.01|0.047
73856254|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.56||||0.005|TWO_SIDED|95.0|0.17|0.95|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|0.17|0.005
73856255|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.53||||0.007|TWO_SIDED|95.0|0.14|0.92|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.92|0.14|0.007
73906712|NCT01675427|147344237|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
73906713|NCT01675427|147344237|SUPERIORITY_OR_OTHER|||||||0.3031|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3031
73906714|NCT01675427|147344237|SUPERIORITY_OR_OTHER|||||||0.955|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9550
73906715|NCT01675427|147344237|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
73906716|NCT01675427|147344238|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
73906717|NCT01675427|147344238|SUPERIORITY_OR_OTHER|||||||0.189|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1890
74025655|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|-7.88|||||TWO_SIDED|95.0|-20.28|3.35||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.35|-20.28|
74025656|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|-10.73|||||TWO_SIDED|95.0|-29.01|8.11||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.11|-29.01|
74025657|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|7.11|||||TWO_SIDED|95.0|-1.52|17.65||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||17.65|-1.52|
73963721|NCT00402246|147463131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.524|ONE_SIDED|95.0||1.21||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple hospitalization events per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the CV hospitalization hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.21||0.524
73963722|NCT00402246|147463131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.325|ONE_SIDED|95.0||1.43||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple ED visits per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the ED hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.43||0.325
73856256|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.276|TWO_SIDED|95.0|-0.42|0.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.12|-0.42|0.276
73856257|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.318|TWO_SIDED|95.0|-0.41|0.13|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-0.41|0.318
73856258|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03||||0.849|TWO_SIDED|95.0|-0.25|0.3|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.25|0.849
73856259|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.138|TWO_SIDED|95.0|-0.09|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.66|-0.09|0.138
73856260|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.111|TWO_SIDED|95.0|-0.07|0.68|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.68|-0.07|0.111
73856261|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.031|TWO_SIDED|95.0|0.04|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.04|0.031
73856262|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.49||||0.011|TWO_SIDED|95.0|0.11|0.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.87|0.11|0.011
73856263|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.2||||0.135|TWO_SIDED|95.0|-0.47|0.06|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.06|-0.47|0.135
74025658|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|-13.37|||||TWO_SIDED|95.0|-29.57|3.31||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.31|-29.57|
73856264|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.175|TWO_SIDED|95.0|-0.44|0.08|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.08|-0.44|0.175
73856265|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.59|TWO_SIDED|95.0|-0.34|0.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.19|-0.34|0.590
73856266|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.402|TWO_SIDED|95.0|-0.2|0.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.49|-0.20|0.402
73856267|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.261|TWO_SIDED|95.0|-0.15|0.54|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.15|0.261
73856268|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.26||||0.134|TWO_SIDED|95.0|-0.08|0.61|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.61|-0.08|0.134
73856269|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.031|TWO_SIDED|95.0|0.03|0.72|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|0.03|0.031
73856270|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.061|TWO_SIDED|95.0|-0.47|0.01|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.01|-0.47|0.061
73856271|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.138|TWO_SIDED|95.0|-0.42|0.06|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.06|-0.42|0.138
73856272|NCT01559259|147258982|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.353|TWO_SIDED|95.0|-0.35|0.13|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-0.35|0.353
73856273|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.88||||0.006|TWO_SIDED|95.0|0.25|1.51|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.51|0.25|0.006
74025659|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|8.09|||||TWO_SIDED|95.0|-0.52|17.81||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||17.81|-0.52|
74025660|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|-7.38|||||TWO_SIDED|95.0|-22.86|8.29||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.29|-22.86|
73906718|NCT01675427|147344238|SUPERIORITY_OR_OTHER|||||||0.5793|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5793
73906719|NCT01675427|147344238|SUPERIORITY_OR_OTHER|||||||0.0847|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0847
73906720|NCT01675427|147344238|SUPERIORITY_OR_OTHER|||||||0.5506|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5506
73906721|NCT01675427|147344238|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0020
73906722|NCT01675427|147344239|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0007
73906723|NCT01675427|147344239|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0061
73906724|NCT01675427|147344239|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
73906725|NCT01675427|147344239|SUPERIORITY_OR_OTHER|||||||0.3885|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3885
73906726|NCT01675427|147344239|SUPERIORITY_OR_OTHER|||||||0.3597|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3597
73906727|NCT01675427|147344239|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
73963723|NCT00402246|147463131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.099|ONE_SIDED|95.0||1.31||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple unscheduled clinic visits per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the hazard rates of the CV unscheduled clinic or urgent care visits for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.31||0.099
73906728|NCT01675427|147344240|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
73906729|NCT01675427|147344240|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0005
73906730|NCT01675427|147344240|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0110
73906731|NCT01675427|147344240|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0980
73963724|NCT00402246|147463132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.29|ONE_SIDED|95.0||2.56||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the hazard rate of transesophageal echocardiography (TEE) taken for patients in the remote arm is equal to that of similar patients in the in-office arm.||2.56||0.29
73906732|NCT01675427|147344240|SUPERIORITY_OR_OTHER|||||||0.2264|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2264
73906733|NCT01675427|147344240|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
73906734|NCT01675427|147344241|SUPERIORITY_OR_OTHER|||||||0.0098|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0098
73906735|NCT01675427|147344241|SUPERIORITY_OR_OTHER|||||||0.6291|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.6291
73963725|NCT00402246|147463135|SUPERIORITY_OR_OTHER||probability|0.23||||||95.0|||||Regression, Logistic|A GEE model was utilized to account for multiple events within same patient in estimating the probability of an AT/AF alert event being symptomatic.||||||
73963726|NCT00402246|147463137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|4.3||0.779|TWO_SIDED|95.0|-0.8|1.0||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is that the time from event onset to clinical decision for symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||1.0|-0.8|0.779
74025661|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|0.51|||||TWO_SIDED|95.0|-8.82|10.08||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.08|-8.82|
74025662|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|-20.19|||||TWO_SIDED|95.0|-35.45|-3.95||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.95|-35.45|
74025663|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|5.25|||||TWO_SIDED|95.0|-8.5|19.06||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||19.06|-8.50|
73906736|NCT01675427|147344241|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0013
73906737|NCT01675427|147344241|SUPERIORITY_OR_OTHER|||||||0.5588|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5588
73906738|NCT01675427|147344241|SUPERIORITY_OR_OTHER|||||||0.9932|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9932
73906739|NCT01675427|147344241|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
74085101|NCT00407745|147723820|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.51|-0.61||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 16.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.61|-1.51|<0.0001
74085102|NCT00407745|147723821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.269||0.0438|TWO_SIDED|95.0|-1.08|-0.02||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline mBPI-10 Total Score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.02|-1.08|0.0438
73906740|NCT01675427|147344242|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0007
73906741|NCT01675427|147344242|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0020
73906742|NCT01675427|147344242|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0013
73906743|NCT01675427|147344242|SUPERIORITY_OR_OTHER|||||||0.7166|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7166
73906744|NCT01675427|147344242|SUPERIORITY_OR_OTHER|||||||0.3217|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3217
73963727|NCT00402246|147463138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_DEVIATION|19.1|<|0.001|TWO_SIDED|95.0|-13.1|-6.9||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is the time from event onset to clinical decision for both device events and symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||-6.9|-13.1|<0.001
73963728|NCT00402246|147463139|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82||||0.002|TWO_SIDED|95.0|0.7|0.9||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis was rejected.|negative binomial model|||The null hypothesis was that the mean LOS per hospitalization visit for patients in the remote arm was equal to that for similar patients in the in-office arm.||0.9|0.7|0.002
73963729|NCT00402246|147463140|SUPERIORITY_OR_OTHER||compliance rate|0.761|||||ONE_SIDED|95.0|0.737||||Binomial Exact Test|||3-month compliance rate|||0.737|
73963730|NCT00402246|147463140|SUPERIORITY_OR_OTHER||compliance rate|0.815|||||ONE_SIDED|95.0|0.793||||Binomial Exact Test|||6-month compliance rate|||0.793|
73963731|NCT00402246|147463140|SUPERIORITY_OR_OTHER||compliance rate|0.815|||||ONE_SIDED|95.0|0.792||||Binomial Exact Test|||9-month compliance rate|||0.792|
73963732|NCT00402246|147463140|SUPERIORITY_OR_OTHER||compliance rate|0.814|||||ONE_SIDED|95.0|0.79||||Binomial Exact Test|||12-month compliance rate|||0.79|
73963733|NCT00402246|147463142|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.||||0.217
73963734|NCT00402246|147463143|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||The a priori threshold for statistical significance for was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.||||0.154
73963735|NCT01808339|147463162|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.077|||||TWO_SIDED|90.0|0.001|0.152|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and Placebo (FF 100 µg AM minus Placebo).|||0.152|0.001|
73963736|NCT01808339|147463162|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.105|||||TWO_SIDED|90.0|0.029|0.18|||||The estimated value represents the difference in Least Squares Means between FF 100 µg PM and Placebo (FF 100 µg PM minus Placebo).|||0.180|0.029|
73906745|NCT01675427|147344242|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
73906746|NCT01675427|147344243|SUPERIORITY_OR_OTHER|||||||0.1894|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.1894
73906747|NCT01675427|147344243|SUPERIORITY_OR_OTHER|||||||0.0054|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0054
73906748|NCT01675427|147344243|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
73963737|NCT01808339|147463162|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.028|||||TWO_SIDED|90.0|-0.102|0.045|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and FF 100 µg PM (FF 100 µg AM minus FF 100 µg PM).|||0.045|-0.102|
73963738|NCT02622568|147463166|NON_INFERIORITY|Veregen alone has efficacy compared to Veregen + cryotherapy|Mean Difference (Final Values)|1.556||||0.383|TWO_SIDED|||||Comparison at week 12|t-test, 2 sided|||||||0.383
73963739|NCT02622568|147463166|NON_INFERIORITY|Comparison at week 0|Mean Difference (Final Values)|-0.222||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
73856274|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.69||||0.03|TWO_SIDED|95.0|0.07|1.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.31|0.07|0.030
73856275|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81||||0.012|TWO_SIDED|95.0|0.17|1.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.44|0.17|0.012
73856276|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.237|TWO_SIDED|95.0|-0.25|1.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.01|-0.25|0.237
73963740|NCT01643616|147463167|SUPERIORITY_OR_OTHER||Percentage Difference|33.0|||<|0.05|||||||Fisher Exact||For success rate without supplementation the difference between group US (94.9%) and group NS (61.9%) is 33%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.||||< 0.05
73963741|NCT01643616|147463168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.9|||<|0.05|TWO_SIDED|95.0|13.6|31.1|||Log Rank|||We used the log-rank test to compare the onset times. The significance level was defined with p\<0.05.||31.1|13.6|< 0.05
73856277|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.5||||0.024|TWO_SIDED|95.0|0.07|0.93|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.93|0.07|0.024
73856278|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.15|TWO_SIDED|95.0|-0.11|0.73|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.73|-0.11|0.150
73856279|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.43||||0.054|TWO_SIDED|95.0|-0.01|0.86|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.01|0.054
73856280|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.89|||<|0.001|TWO_SIDED|95.0|1.92|3.85|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.85|1.92|<0.001
73856281|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.52|||<|0.001|TWO_SIDED|95.0|1.56|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.47|1.56|<0.001
73856282|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.51|||<|0.001|TWO_SIDED|95.0|1.54|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.47|1.54|<0.001
73963742|NCT01643616|147463169|SUPERIORITY_OR_OTHER||Percentage Difference|26.2||||0.05|||||||Fisher Exact||For success rate with supplementation the difference between group US (98.2%) and group NS (72%) is 26.2%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.||||0.05
73963743|NCT01854385|147463174|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|||||||.079
73963744|NCT01266122|147463178|SUPERIORITY_OR_OTHER||log(Incident Risk Ratio)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.47|-0.44|||Mixed Models Analysis|Mixed effects Poisson regression||Intent to treat analysis||-.44|-1.47|<.001
73963745|NCT01266122|147463179|SUPERIORITY_OR_OTHER||Chi-square statistic|1.39|||=|0.239|TWO_SIDED||||||Chi-squared|||Intent to treat analysis.||||=.239
73963746|NCT03756571|147463181|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
73963747|NCT03756571|147463182|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
73963748|NCT03756571|147463183|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
73963749|NCT03756571|147463184|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
73963750|NCT03756571|147463185|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
73856283|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.76|||<|0.001|TWO_SIDED|95.0|0.79|2.72|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.72|0.79|<0.001
73963751|NCT03756571|147463186|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
73856284|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.13|||<|0.001|TWO_SIDED|95.0|0.47|1.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.79|0.47|<0.001
73963752|NCT03756571|147463187|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
73963753|NCT03756571|147463188|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
73963754|NCT03756571|147463189|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
73963755|NCT03756571|147463190|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
73906749|NCT01675427|147344243|SUPERIORITY_OR_OTHER|||||||0.536|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5360
73906750|NCT01675427|147344243|SUPERIORITY_OR_OTHER|||||||0.2185|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2185
73906751|NCT01675427|147344243|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
73906752|NCT01675427|147344244|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0002
73906753|NCT01675427|147344244|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0003
73906754|NCT01675427|147344244|SUPERIORITY_OR_OTHER|||||||0.0106|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0106
73906755|NCT01675427|147344244|SUPERIORITY_OR_OTHER|||||||0.7821|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7821
73906756|NCT01675427|147344244|SUPERIORITY_OR_OTHER|||||||0.2372|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2372
73963756|NCT03756571|147463191|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
73963757|NCT03756571|147463192|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
73963758|NCT00520546|147463207|SUPERIORITY_OR_OTHER||sensitivity|97.0||||0.0526|TWO_SIDED|95.0|86.0|100.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||100|86|0.0526
73963759|NCT00520546|147463207|SUPERIORITY_OR_OTHER||specificity|0.0||||0.0526|TWO_SIDED|95.0|0.0|98.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||98|0|0.0526
73906757|NCT01675427|147344244|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
73906758|NCT01675427|147344245|SUPERIORITY_OR_OTHER|||||||0.0688|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0688
73906759|NCT01675427|147344245|SUPERIORITY_OR_OTHER|||||||0.4367|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.4367
73906760|NCT01675427|147344245|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
73906761|NCT01675427|147344245|SUPERIORITY_OR_OTHER|||||||0.1951|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1951
73906762|NCT01675427|147344245|SUPERIORITY_OR_OTHER|||||||0.2927|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2927
73906763|NCT01675427|147344245|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0013
73963760|NCT00520546|147463207|SUPERIORITY_OR_OTHER||accuracy|95.0||||0.0526|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0526
73963761|NCT00520546|147463207|SUPERIORITY_OR_OTHER||sensitivity|70.0|||<|0.0001|TWO_SIDED|95.0|53.0|84.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||84|53|<0.0001
73963762|NCT00520546|147463207|SUPERIORITY_OR_OTHER||specificity|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|98.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||98|0|<0.0001
73963763|NCT00520546|147463207|SUPERIORITY_OR_OTHER||accuracy|68.0|||<|0.0001|TWO_SIDED|95.0|51.0|83.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||83|51|<0.0001
73906764|NCT01675427|147344246|SUPERIORITY_OR_OTHER|||||||0.0247|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0247
73906765|NCT01675427|147344246|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0034
73906766|NCT01675427|147344246|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0017
73906767|NCT01675427|147344246|SUPERIORITY_OR_OTHER|||||||0.3346|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3346
73906768|NCT01675427|147344246|SUPERIORITY_OR_OTHER|||||||0.3215|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3215
73906769|NCT01675427|147344246|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0003
73906770|NCT01675427|147344247|SUPERIORITY_OR_OTHER|||||||0.3609|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.3609
73963764|NCT00520546|147463207|SUPERIORITY_OR_OTHER||sensitivity|95.0||||0.0043|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0043
74085103|NCT00407745|147723822|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.448||0.7103|TWO_SIDED|95.0|-1.06|0.72||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/above level: within 2 dermatomes above or below the neurological level of injury (NLI).~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.72|-1.06|0.7103
73856285|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.76||||0.021|TWO_SIDED|95.0|0.11|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.11|0.021
73856286|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.75||||0.027|TWO_SIDED|95.0|0.09|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.09|0.027
73856287|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.75|||<|0.001|TWO_SIDED|95.0|3.65|5.84|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.84|3.65|<0.001
73856288|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.21|||<|0.001|TWO_SIDED|95.0|3.13|5.29|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.29|3.13|<0.001
73856289|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.47|||<|0.001|TWO_SIDED|95.0|3.37|5.56|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.56|3.37|<0.001
73856290|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.92|||<|0.001|TWO_SIDED|95.0|2.83|5.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.02|2.83|<0.001
73856291|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.031|TWO_SIDED|95.0|0.08|1.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.58|0.08|0.031
73856292|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.442|TWO_SIDED|95.0|-0.44|1.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|-0.44|0.442
73963765|NCT00520546|147463207|SUPERIORITY_OR_OTHER||specificity|100.0||||0.0043|TWO_SIDED|95.0|3.0|100.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||100|3|0.0043
73963766|NCT00520546|147463207|SUPERIORITY_OR_OTHER||accuracy|95.0||||0.0043|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0043
73963767|NCT00520546|147463208|SUPERIORITY_OR_OTHER||positive prediction|69.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
73963768|NCT00520546|147463208|SUPERIORITY_OR_OTHER||negative prediction|44.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
73963769|NCT00520546|147463208|SUPERIORITY_OR_OTHER||sensitivity|71.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
73856293|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.152|TWO_SIDED|95.0|-0.2|1.3|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|-0.20|0.152
73856294|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.62|||<|0.001|TWO_SIDED|95.0|4.52|6.72|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.72|4.52|<0.001
73856295|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.04|||<|0.001|TWO_SIDED|95.0|3.96|6.13|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.13|3.96|<0.001
73856296|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.4|||<|0.001|TWO_SIDED|95.0|4.3|6.5|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.50|4.30|<0.001
73856297|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.88|||<|0.001|TWO_SIDED|95.0|3.78|5.98|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.98|3.78|<0.001
74025664|NCT01193335|147604211|SUPERIORITY_OR_OTHER||Percent Difference|-3.14|||||TWO_SIDED|95.0|-17.51|11.13||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.13|-17.51|
74025665|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-5.59|5.89||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.89|-5.59|
74085104|NCT00407745|147723822|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.34||0.0747|TWO_SIDED|95.0|-1.28|0.06||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level: more than 2 dermatomes below the NLI.~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.06|-1.28|0.0747
74085105|NCT00407745|147723823|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.379||0.5689|TWO_SIDED|95.0|-0.97|0.54||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.54|-0.97|0.5689
74085106|NCT00407745|147723823|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.322||0.4764|TWO_SIDED|95.0|-0.87|0.41||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.41|-0.87|0.4764
74085107|NCT00407745|147723824|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.474||0.3362|TWO_SIDED|95.0|-1.4|0.48||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.48|-1.40|0.3362
73906771|NCT01675427|147344247|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0018
73906772|NCT01675427|147344247|SUPERIORITY_OR_OTHER|||||||0.0356|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0356
73906773|NCT01675427|147344247|SUPERIORITY_OR_OTHER|||||||0.7044|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7044
73906774|NCT01675427|147344247|SUPERIORITY_OR_OTHER|||||||0.8578|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.8578
73906775|NCT01675427|147344247|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0076
73906776|NCT01675427|147344248|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0002
73906777|NCT01675427|147344248|SUPERIORITY_OR_OTHER|||||||0.2017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2017
73906778|NCT01675427|147344248|SUPERIORITY_OR_OTHER|||||||0.5878|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5878
73906779|NCT01675427|147344248|SUPERIORITY_OR_OTHER|||||||0.4144|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4144
73906780|NCT01675427|147344248|SUPERIORITY_OR_OTHER|||||||0.4492|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4492
73906781|NCT01675427|147344248|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
74025666|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|0.08|||||TWO_SIDED|95.0|-6.81|7.37||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.37|-6.81|
74025667|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|-1.55|||||TWO_SIDED|95.0|-10.87|7.44||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.44|-10.87|
74025668|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-5.94|5.94||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.94|-5.94|
74025669|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|-1.61|||||TWO_SIDED|95.0|-8.66|4.25||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.25|-8.66|
74025670|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|-6.64|||||TWO_SIDED|95.0|-17.93|3.56||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.56|-17.93|
74025671|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|0.05|||||TWO_SIDED|95.0|-6.74|7.04||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.04|-6.74|
73906782|NCT01675427|147344249|SUPERIORITY_OR_OTHER|||||||0.0671|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0671
73906783|NCT01675427|147344249|SUPERIORITY_OR_OTHER|||||||0.1009|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1009
73906784|NCT01675427|147344249|SUPERIORITY_OR_OTHER|||||||0.0635|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0635
73906785|NCT01675427|147344249|SUPERIORITY_OR_OTHER|||||||0.4162|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4162
73906786|NCT01675427|147344249|SUPERIORITY_OR_OTHER|||||||0.9305|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9305
73906787|NCT01675427|147344249|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0041
73963770|NCT00520546|147463208|SUPERIORITY_OR_OTHER||specificity|42.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
73963771|NCT00520546|147463208|SUPERIORITY_OR_OTHER||accuracy|61.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
73963772|NCT00520546|147463208|SUPERIORITY_OR_OTHER||positive prediction|60.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
73963773|NCT00520546|147463208|SUPERIORITY_OR_OTHER||negative prediction|30.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
73906788|NCT01675427|147344250|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0059
73906789|NCT01675427|147344250|SUPERIORITY_OR_OTHER|||||||0.2808|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2808
73906790|NCT01675427|147344250|SUPERIORITY_OR_OTHER|||||||0.2401|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2401
73963774|NCT00520546|147463208|SUPERIORITY_OR_OTHER||sensitivity|48.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
73906791|NCT01675427|147344250|SUPERIORITY_OR_OTHER|||||||0.2993|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.2993
73906792|NCT01675427|147344250|SUPERIORITY_OR_OTHER|||||||0.5529|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5529
73906793|NCT01675427|147344250|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0005
73906794|NCT01675427|147344251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
73963775|NCT00520546|147463208|SUPERIORITY_OR_OTHER||specificity|40.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
74025672|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|-6.48|||||TWO_SIDED|95.0|-16.37|2.75||||||Serotype 1: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||2.75|-16.37|
74025673|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|1.27|||||TWO_SIDED|95.0|-3.37|6.85||||||Serotype 3: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||6.85|-3.37|
74025674|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|-1.34|||||TWO_SIDED|95.0|-8.36|5.14||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.14|-8.36|
73906795|NCT01675427|147344251|SUPERIORITY_OR_OTHER|||||||0.3572|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.3572
73906796|NCT01675427|147344251|SUPERIORITY_OR_OTHER|||||||0.2041|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.2041
73906797|NCT01675427|147344251|SUPERIORITY_OR_OTHER|||||||0.0467|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.0467
73906798|NCT01675427|147344251|SUPERIORITY_OR_OTHER|||||||0.0525|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0525
73906799|NCT01675427|147344251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
74085108|NCT00407745|147723824|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.321||0.3113|TWO_SIDED|95.0|-0.96|0.31||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.31|-0.96|0.3113
73906800|NCT01675427|147344252|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
73906801|NCT01675427|147344252|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
73906802|NCT01675427|147344252|SUPERIORITY_OR_OTHER|||||||0.5275|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5275
73906803|NCT01675427|147344252|SUPERIORITY_OR_OTHER|||||||0.6593|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.6593
73906804|NCT01675427|147344252|SUPERIORITY_OR_OTHER|||||||0.0372|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0372
73906805|NCT01675427|147344252|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
73906806|NCT01675427|147344253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
73906807|NCT01675427|147344253|SUPERIORITY_OR_OTHER|||||||0.3857|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.3857
73963776|NCT00520546|147463208|SUPERIORITY_OR_OTHER||accuracy|45.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
73963777|NCT00520546|147463208|SUPERIORITY_OR_OTHER||positive prediction|87.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963778|NCT00520546|147463208|SUPERIORITY_OR_OTHER||negative prediction|57.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963779|NCT00520546|147463208|SUPERIORITY_OR_OTHER||sensitivity|66.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963780|NCT00520546|147463208|SUPERIORITY_OR_OTHER||specificity|82.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73906808|NCT01675427|147344253|SUPERIORITY_OR_OTHER|||||||0.2356|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.2356
73906809|NCT01675427|147344253|SUPERIORITY_OR_OTHER|||||||0.7993|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.7993
73906810|NCT01675427|147344253|SUPERIORITY_OR_OTHER|||||||0.2164|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.2164
73906811|NCT01675427|147344253|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
73906812|NCT01675427|147344254|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
73906813|NCT01675427|147344254|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.0001
73906814|NCT01675427|147344254|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.4820
73906815|NCT01675427|147344254|SUPERIORITY_OR_OTHER|||||||0.8668|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.8668
73906816|NCT01675427|147344254|SUPERIORITY_OR_OTHER|||||||0.2032|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.2032
73906817|NCT01675427|147344254|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
73906818|NCT01675427|147344255|SUPERIORITY_OR_OTHER|||||||0.0103|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||0.0103
73906819|NCT01675427|147344255|SUPERIORITY_OR_OTHER|||||||0.8373|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.8373
73906820|NCT01675427|147344255|SUPERIORITY_OR_OTHER|||||||0.3672|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.3672
73906821|NCT01675427|147344256|SUPERIORITY_OR_OTHER|||||||0.0637|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.0637
73906822|NCT01675427|147344256|SUPERIORITY_OR_OTHER|||||||0.0474|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0474
74085109|NCT00407745|147723825|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.539||0.2721|TWO_SIDED|95.0|-1.67|0.48||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.48|-1.67|0.2721
73906823|NCT01675427|147344256|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
73906824|NCT01675427|147344257|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
73906825|NCT01675427|147344257|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
73906826|NCT01675427|147344257|SUPERIORITY_OR_OTHER|||||||0.5522|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5522
73906827|NCT01675427|147344258|SUPERIORITY_OR_OTHER|||||||0.5117|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.5117
73906828|NCT01675427|147344258|SUPERIORITY_OR_OTHER|||||||0.3437|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.3437
73906829|NCT01675427|147344258|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
73906830|NCT01675427|147344259|SUPERIORITY_OR_OTHER|||||||0.0381|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||0.0381
73906831|NCT01675427|147344259|SUPERIORITY_OR_OTHER|||||||0.6852|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.6852
73963781|NCT00520546|147463208|SUPERIORITY_OR_OTHER||accuracy|72.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963782|NCT00520546|147463209|SUPERIORITY_OR_OTHER||positive prediction|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963783|NCT00520546|147463209|SUPERIORITY_OR_OTHER||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73906832|NCT01675427|147344259|SUPERIORITY_OR_OTHER|||||||0.1185|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.1185
73906833|NCT01675427|147344260|SUPERIORITY_OR_OTHER|||||||0.2611|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.2611
73906834|NCT01675427|147344260|SUPERIORITY_OR_OTHER|||||||0.6059|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.6059
73906835|NCT01675427|147344260|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0001
73906836|NCT01675427|147344261|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
73906837|NCT01675427|147344261|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.0048
73906838|NCT01675427|147344261|SUPERIORITY_OR_OTHER|||||||0.5127|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5127
73906839|NCT01675427|147344262|SUPERIORITY_OR_OTHER|||||||0.3465|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.3465
73906840|NCT01675427|147344262|SUPERIORITY_OR_OTHER|||||||0.7358|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7358
73906841|NCT01675427|147344262|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
73906842|NCT01675427|147344263|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
73906843|NCT01675427|147344264|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
73906844|NCT01675427|147344265|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
73906845|NCT01675427|147344266|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||0.0066
73906846|NCT01675427|147344267|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0018
73906847|NCT01675427|147344267|SUPERIORITY_OR_OTHER|||||||0.0425|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.0425
73906848|NCT01675427|147344267|SUPERIORITY_OR_OTHER|||||||0.9829|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.9829
73906849|NCT01675427|147344267|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.6700
73906850|NCT01675427|147344267|SUPERIORITY_OR_OTHER|||||||0.7672|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7672
73906851|NCT01675427|147344267|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0067
73906852|NCT01675427|147344268|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0003
73856298|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.055|TWO_SIDED|95.0|-0.01|1.49|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.49|-0.01|0.055
73856299|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.666|TWO_SIDED|95.0|-0.57|0.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.90|-0.57|0.666
73856300|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.51||||0.181|TWO_SIDED|95.0|-0.24|1.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.27|-0.24|0.181
73856301|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.86|||<|0.001|TWO_SIDED|95.0|4.71|7.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||7.01|4.71|<0.001
73856302|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.43|||<|0.001|TWO_SIDED|95.0|4.29|6.57|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.57|4.29|<0.001
73856303|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.79|||<|0.001|TWO_SIDED|95.0|4.64|6.94|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.94|4.64|<0.001
73856304|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.34|||<|0.001|TWO_SIDED|95.0|4.19|6.5|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.50|4.19|<0.001
73856305|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.52||||0.2|TWO_SIDED|95.0|-0.27|1.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.31|-0.27|0.200
73856306|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.08||||0.831|TWO_SIDED|95.0|-0.69|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.85|-0.69|0.831
73856307|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.268|TWO_SIDED|95.0|-0.34|1.24|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|-0.34|0.268
73856308|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.73|||<|0.001|TWO_SIDED|95.0|4.54|6.91|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.91|4.54|<0.001
73856309|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.31|||<|0.001|TWO_SIDED|95.0|4.13|6.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.48|4.13|<0.001
73856310|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.6|||<|0.001|TWO_SIDED|95.0|4.41|6.78|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.78|4.41|<0.001
73856311|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.35|||<|0.001|TWO_SIDED|95.0|4.17|6.54|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.54|4.17|<0.001
73856312|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.367|TWO_SIDED|95.0|-0.44|1.19|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.19|-0.44|0.367
73906853|NCT01675427|147344268|SUPERIORITY_OR_OTHER|||||||0.1637|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.1637
73906854|NCT01675427|147344268|SUPERIORITY_OR_OTHER|||||||0.8579|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.8579
74025675|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.73|5.04||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.04|-4.73|
74025676|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.48|4.55||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.55|-4.48|
73906855|NCT01675427|147344268|SUPERIORITY_OR_OTHER|||||||0.6935|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.6935
73906856|NCT01675427|147344268|SUPERIORITY_OR_OTHER|||||||0.8124|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.8124
73906857|NCT01675427|147344268|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
73906858|NCT01675427|147344269|SUPERIORITY_OR_OTHER|||||||0.1834|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.1834
73906859|NCT01675427|147344269|SUPERIORITY_OR_OTHER|||||||0.8543|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.8543
73906860|NCT01675427|147344269|SUPERIORITY_OR_OTHER|||||||0.1485|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.1485
73906861|NCT01675427|147344269|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.0260
73906862|NCT01675427|147344269|SUPERIORITY_OR_OTHER|||||||0.5317|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.5317
73906863|NCT01675427|147344269|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0005
73906864|NCT01675427|147344270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
73906865|NCT01675427|147344270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
73906866|NCT01675427|147344270|SUPERIORITY_OR_OTHER|||||||0.4423|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.4423
73906867|NCT01675427|147344270|SUPERIORITY_OR_OTHER|||||||0.3824|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.3824
73906868|NCT01675427|147344270|SUPERIORITY_OR_OTHER|||||||0.5246|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.5246
73906869|NCT01675427|147344270|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
73906870|NCT01675427|147344271|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
73906871|NCT01675427|147344271|SUPERIORITY_OR_OTHER|||||||0.1947|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.1947
73906872|NCT01675427|147344271|SUPERIORITY_OR_OTHER|||||||0.0226|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.0226
73906873|NCT01675427|147344272|SUPERIORITY_OR_OTHER|||||||0.1158|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.1158
73906874|NCT01675427|147344272|SUPERIORITY_OR_OTHER|||||||0.3675|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.3675
73906875|NCT01675427|147344272|SUPERIORITY_OR_OTHER|||||||0.0948|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0948
73906876|NCT01675427|147344273|SUPERIORITY_OR_OTHER|||||||0.1236|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.1236
73906877|NCT01675427|147344273|SUPERIORITY_OR_OTHER|||||||0.0119|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.0119
73906878|NCT01675427|147344273|SUPERIORITY_OR_OTHER|||||||0.7472|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.7472
73906879|NCT01675427|147344274|SUPERIORITY_OR_OTHER|||||||0.9734|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.9734
73906880|NCT01675427|147344274|SUPERIORITY_OR_OTHER|||||||0.8303|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.8303
74025677|NCT01193335|147604212|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.48|4.55||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.55|-4.48|
74025678|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-7.5|||||TWO_SIDED|95.0|-24.5|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.9|-24.5|
74025679|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-5.9|||||TWO_SIDED|95.0|-23.6|11.8||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.8|-23.6|
74025680|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-10.7|||||TWO_SIDED|95.0|-27.6|6.0||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||6.0|-27.6|
73906881|NCT01675427|147344274|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0006
73906882|NCT01675427|147344275|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0065
73906883|NCT01675427|147344275|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.9999
73906884|NCT01675427|147344275|SUPERIORITY_OR_OTHER|||||||0.3472|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.3472
73906885|NCT01675427|147344276|SUPERIORITY_OR_OTHER|||||||0.2564|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.2564
73856313|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.908|TWO_SIDED|95.0|-0.84|0.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|-0.84|0.908
73856314|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.553|TWO_SIDED|95.0|-0.57|1.06|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.06|-0.57|0.553
73856315|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.45|||<|0.001|TWO_SIDED|95.0|4.22|6.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.68|4.22|<0.001
73856316|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.1|||<|0.001|TWO_SIDED|95.0|3.88|6.31|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.31|3.88|<0.001
73856317|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.42|||<|0.001|TWO_SIDED|95.0|4.19|6.66|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.66|4.19|<0.001
73856318|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.17|||<|0.001|TWO_SIDED|95.0|3.94|6.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.40|3.94|<0.001
73856319|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.28||||0.518|TWO_SIDED|95.0|-0.57|1.12|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.12|-0.57|0.518
73906886|NCT01675427|147344276|SUPERIORITY_OR_OTHER|||||||0.7361|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7361
73906887|NCT01675427|147344276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
73906888|NCT01675427|147344277|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0097
73906889|NCT01675427|147344277|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
73856320|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.86|TWO_SIDED|95.0|-0.9|0.75|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|-0.90|0.860
73856321|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.556|TWO_SIDED|95.0|-0.59|1.1|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|-0.59|0.556
73856322|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.44|||<|0.001|TWO_SIDED|95.0|4.17|6.71|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.71|4.17|<0.001
73856323|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.93|||<|0.001|TWO_SIDED|95.0|3.68|6.19|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.19|3.68|<0.001
73906890|NCT01675427|147344277|SUPERIORITY_OR_OTHER|||||||0.9778|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.9778
73906891|NCT01675427|147344278|SUPERIORITY_OR_OTHER|||||||0.0151|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.0151
73906892|NCT01675427|147344278|SUPERIORITY_OR_OTHER|||||||0.1052|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.1052
73906893|NCT01675427|147344278|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0007
74025681|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-4.3|||||TWO_SIDED|95.0|-17.0|8.4||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.4|-17.0|
74025682|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-23.0|||||TWO_SIDED|95.0|-40.0|-4.9||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-4.9|-40.0|
73856324|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.27|||<|0.001|TWO_SIDED|95.0|4.0|6.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.54|4.00|<0.001
73856325|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.06|||<|0.001|TWO_SIDED|95.0|3.79|6.34|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.34|3.79|<0.001
73856326|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.392|TWO_SIDED|95.0|-0.49|1.25|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.25|-0.49|0.392
73856327|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.13||||0.762|TWO_SIDED|95.0|-0.98|0.72|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|-0.98|0.762
73856328|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.21||||0.638|TWO_SIDED|95.0|-0.66|1.08|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|-0.66|0.638
73856329|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.55|||<|0.001|TWO_SIDED|95.0|3.2|5.9|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.90|3.20|<0.001
73856330|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.45|||<|0.001|TWO_SIDED|95.0|3.11|5.78|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.78|3.11|<0.001
73906894|NCT01675427|147344279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
73856331|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.91|||<|0.001|TWO_SIDED|95.0|3.56|6.26|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.26|3.56|<0.001
73856332|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.39|||<|0.001|TWO_SIDED|95.0|3.04|5.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.74|3.04|<0.001
73856333|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.741|TWO_SIDED|95.0|-0.77|1.08|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|-0.77|0.741
73856334|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.05||||0.907|TWO_SIDED|95.0|-0.85|0.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|-0.85|0.907
73856335|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.51||||0.274|TWO_SIDED|95.0|-0.41|1.44|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.44|-0.41|0.274
73906895|NCT01675427|147344279|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0012
74025683|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-11.9|||||TWO_SIDED|95.0|-27.4|3.4||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.4|-27.4|
74025684|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-28.2|||||TWO_SIDED|95.0|-43.9|-11.0||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-11.0|-43.9|
74025685|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-0.3|||||TWO_SIDED|95.0|-10.9|10.3||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.3|-10.9|
74025686|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-1.2|||||TWO_SIDED|95.0|-17.5|15.1||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||15.1|-17.5|
74025687|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-10.6|||||TWO_SIDED|95.0|-25.3|4.5||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.5|-25.3|
74025688|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-18.6|||||TWO_SIDED|95.0|-33.3|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.0|-33.3|
74025689|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|2.8|||||TWO_SIDED|95.0|-7.1|13.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||13.1|-7.1|
74025690|NCT01193335|147604213|SUPERIORITY_OR_OTHER||Percent Difference|-18.5|||||TWO_SIDED|95.0|-33.7|-2.8||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.8|-33.7|
74025691|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|-7.9|||||TWO_SIDED|95.0|-25.2|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.9|-25.2|
74025692|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|0.3|||||TWO_SIDED|95.0|-18.5|19.0||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||19.0|-18.5|
73856336|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.77|||<|0.001|TWO_SIDED|95.0|2.4|5.13|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.13|2.40|<0.001
73856337|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.91|||<|0.001|TWO_SIDED|95.0|2.56|5.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.26|2.56|<0.001
73856338|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.12|||<|0.001|TWO_SIDED|95.0|2.75|5.48|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.48|2.75|<0.001
73856339|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.01|||<|0.001|TWO_SIDED|95.0|2.64|5.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.38|2.64|<0.001
73856340|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.607|TWO_SIDED|95.0|-1.18|0.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.69|-1.18|0.607
73856341|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.824|TWO_SIDED|95.0|-1.02|0.81|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-1.02|0.824
73856342|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.827|TWO_SIDED|95.0|-0.83|1.04|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.04|-0.83|0.827
73856343|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.98|||<|0.001|TWO_SIDED|95.0|1.58|4.39|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.39|1.58|<0.001
73906896|NCT01675427|147344279|SUPERIORITY_OR_OTHER|||||||0.1717|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1717
73906897|NCT01675427|147344279|SUPERIORITY_OR_OTHER|||||||0.0253|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0253
73906898|NCT01675427|147344280|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
73906899|NCT01675427|147344280|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0330
73906900|NCT01675427|147344280|SUPERIORITY_OR_OTHER|||||||0.1595|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1595
73906901|NCT01675427|147344280|SUPERIORITY_OR_OTHER|||||||0.0412|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0412
73906902|NCT01675427|147344281|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||< 0.0001
73906903|NCT01675427|147344281|SUPERIORITY_OR_OTHER|||||||0.0421|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.0421
73906904|NCT01675427|147344281|SUPERIORITY_OR_OTHER|||||||0.7658|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7658
74025693|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|7.3|||||TWO_SIDED|95.0|-12.0|26.2||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||26.2|-12.0|
74025694|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|-2.8|||||TWO_SIDED|95.0|-19.1|13.3||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||13.3|-19.1|
74025695|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|-17.9|||||TWO_SIDED|95.0|-34.6|-0.3||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-0.3|-34.6|
74025696|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|-4.3|||||TWO_SIDED|95.0|-20.6|12.1||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||12.1|-20.6|
74025697|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|-21.1|||||TWO_SIDED|95.0|-37.8|-3.2||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.2|-37.8|
74025698|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|5.6|||||TWO_SIDED|95.0|-2.7|15.2||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||15.2|-2.7|
74025699|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|-5.1|||||TWO_SIDED|95.0|-22.0|12.0||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||12.0|-22.0|
74025700|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|-14.4|||||TWO_SIDED|95.0|-26.7|-2.4||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.4|-26.7|
74025701|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|-20.4|||||TWO_SIDED|95.0|-36.8|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.0|-36.8|
74025702|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent Difference|-11.3|||||TWO_SIDED|95.0|-26.4|4.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.1|-26.4|
74025703|NCT01193335|147604214|SUPERIORITY_OR_OTHER||Percent difference|-21.6|||||TWO_SIDED|95.0|-37.7|-4.6||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-4.6|-37.7|
74025704|NCT01733329|147604215|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
74025705|NCT01733329|147604216|SUPERIORITY_OR_OTHER|||||||0.026|||||||Fisher Exact|||||||0.026
74025706|NCT01733329|147604217|SUPERIORITY_OR_OTHER|||||||0.058|||||||Fisher Exact|||||||0.058
74025707|NCT01733329|147604218|SUPERIORITY_OR_OTHER|||||||0.007|||||||Kruskal-Wallis|||||||0.007
74025708|NCT04207710|147604219|SUPERIORITY|||||||0.317||||||A priori threshold for significance was p\<0.05.|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.||||0.317
74025709|NCT04207710|147604219|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.||||0.317
73856344|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.27|||<|0.001|TWO_SIDED|95.0|1.88|4.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.65|1.88|<0.001
74025710|NCT04207710|147604219|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.||||0.317
74025711|NCT04207710|147604219|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.||||0.317
73856345|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.12|||<|0.001|TWO_SIDED|95.0|1.71|4.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.52|1.71|<0.001
73856346|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.57|||<|0.001|TWO_SIDED|95.0|2.16|4.98|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.98|2.16|<0.001
73856347|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.59||||0.232|TWO_SIDED|95.0|-1.55|0.38|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.55|0.232
73856348|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.31||||0.522|TWO_SIDED|95.0|-1.24|0.63|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.63|-1.24|0.522
73856349|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.45||||0.356|TWO_SIDED|95.0|-1.41|0.51|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.51|-1.41|0.356
73856350|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.31||||0.001|TWO_SIDED|95.0|0.92|3.69|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.69|0.92|0.001
73856351|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.45|||<|0.001|TWO_SIDED|95.0|1.08|3.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.82|1.08|<0.001
73856352|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.7|||<|0.001|TWO_SIDED|95.0|1.31|4.08|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.08|1.31|<0.001
73856353|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.85|||<|0.001|TWO_SIDED|95.0|1.46|4.23|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.23|1.46|<0.001
73856354|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54||||0.264|TWO_SIDED|95.0|-1.49|0.41|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.41|-1.49|0.264
73856355|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.4||||0.4|TWO_SIDED|95.0|-1.32|0.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-1.32|0.400
73906905|NCT01675427|147344281|SUPERIORITY_OR_OTHER|||||||0.295|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.2950
73906906|NCT01675427|147344282|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||< 0.0001
73906907|NCT01675427|147344282|SUPERIORITY_OR_OTHER|||||||0.0827|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.0827
74025712|NCT03826914|147604222|SUPERIORITY||Median Difference (Net)|-0.43||||0.042|TWO_SIDED|95.0|-0.846|-0.015||The threshold of significance was P=0.05|Anaylsis of Covariance||Placebo - Cardioflex|The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.||-0.015|-0.846|0.042
74025713|NCT03826914|147604223|SUPERIORITY||Mean Difference (Final Values)|-6.772||||0.04|TWO_SIDED|95.0|-11.2|-2.24||The threshold of significance was P=0.05|Anaylsis of Covariance|||The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.||-2.24|-11.2|0.04
74025714|NCT04233424|147604227|SUPERIORITY||Risk Ratio (RR)|-2.8||||0.152|TWO_SIDED|95.0|-6.7|1.0|||Cochran-Mantel-Haenszel|||||1.0|-6.7|0.152
74025715|NCT04233424|147604228|SUPERIORITY||Risk Ratio (RR)|-0.8||||0.6219|TWO_SIDED|95.0|-3.9|2.3|||Cochran-Mantel-Haenszel|||||2.3|-3.9|0.6219
74025716|NCT04233424|147604229|SUPERIORITY||Risk Ratio (RR)|-0.8||||0.4373|TWO_SIDED|95.0|-2.8|1.2|||Kaplan-Meier Analysis|||||1.2|-2.8|0.4373
74025717|NCT02698189|147604230|OTHER|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.000; upper = 0.415|||
74025718|NCT02698189|147604230|OTHER|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.040; upper = 0.391|||
74085110|NCT00407745|147723825|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.337||0.4906|TWO_SIDED|95.0|-0.43|0.9||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.90|-0.43|0.4906
73856356|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.758|TWO_SIDED|95.0|-1.1|0.8|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.80|-1.10|0.758
73856357|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.62||||0.018|TWO_SIDED|95.0|0.27|2.97|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.97|0.27|0.018
73906908|NCT01675427|147344282|SUPERIORITY_OR_OTHER|||||||0.7817|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7817
73906909|NCT01675427|147344282|SUPERIORITY_OR_OTHER|||||||0.1986|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.1986
73906910|NCT01675427|147344283|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
73906911|NCT01675427|147344283|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0002
73906912|NCT01675427|147344283|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0394
74025719|NCT01254344|147604251|NON_INFERIORITY_OR_EQUIVALENCE|"Assuming a 70% rate (i.e., proportion of participants with success of prophylaxis) for both groups and a significance level of 0.025, at least 200 evaluable participants per group were needed to have 90% probability that the lower limit of the 95% (two-sided) confidence interval for the difference in the response rates between the 2 groups was greater than -15 percentage points."|Difference in percentage of prophylaxis|0.1|||||TWO_SIDED|95.0|-5.2|5.5|||Miettinen and Nurminen|||||5.5|-5.2|
74025720|NCT01254344|147604252|SUPERIORITY_OR_OTHER||Difference in percentage of prophylaxis|1.3|||||TWO_SIDED|95.0|-2.2|5.1|||Miettinen and Nurminen|||||5.1|-2.2|
74025721|NCT01982630|147604257|OTHER||Difference of Least Squares Means|-0.23|||||TWO_SIDED|90.0|-4.59|4.13|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.13|-4.59|
74025722|NCT01982630|147604257|OTHER||Difference of Least Squares Means|-6.25|||||TWO_SIDED|90.0|-10.48|-2.01|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-2.01|-10.48|
73906913|NCT01675427|147344283|SUPERIORITY_OR_OTHER|||||||0.0493|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0493
73906914|NCT01675427|147344284|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
73906915|NCT01675427|147344284|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0196
73906916|NCT01675427|147344284|SUPERIORITY_OR_OTHER|||||||0.3268|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.3268
73906917|NCT01675427|147344284|SUPERIORITY_OR_OTHER|||||||0.1667|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1667
73906918|NCT01675427|147344285|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0021
73906919|NCT01675427|147344285|SUPERIORITY_OR_OTHER|||||||0.5319|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.5319
73906920|NCT01675427|147344285|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.0114
73906921|NCT01675427|147344285|SUPERIORITY_OR_OTHER|||||||0.2293|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.2293
73963784|NCT00520546|147463209|SUPERIORITY_OR_OTHER||sensitivity|90.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73906922|NCT01675427|147344285|SUPERIORITY_OR_OTHER|||||||0.2857|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.2857
73906923|NCT01675427|147344285|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.0001
73906924|NCT01675427|147344286|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0081
73906925|NCT01675427|147344286|SUPERIORITY_OR_OTHER|||||||0.0563|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.0563
73963785|NCT00520546|147463209|SUPERIORITY_OR_OTHER||specificity|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963786|NCT00520546|147463209|SUPERIORITY_OR_OTHER||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73906926|NCT01675427|147344286|SUPERIORITY_OR_OTHER|||||||0.3516|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.3516
73906927|NCT01675427|147344286|SUPERIORITY_OR_OTHER|||||||0.0064|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.0064
73906928|NCT01675427|147344286|SUPERIORITY_OR_OTHER|||||||0.2707|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.2707
73906929|NCT01675427|147344286|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||< 0.0001
73906930|NCT01675427|147344287|SUPERIORITY_OR_OTHER|||||||0.0634|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0634
73906931|NCT01675427|147344287|SUPERIORITY_OR_OTHER|||||||0.7176|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.7176
73963787|NCT00520546|147463209|SUPERIORITY_OR_OTHER||positive prediction|71.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
73906932|NCT01675427|147344287|SUPERIORITY_OR_OTHER|||||||0.3944|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.3944
73906933|NCT01675427|147344287|SUPERIORITY_OR_OTHER|||||||0.861|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.8610
73906934|NCT01675427|147344287|SUPERIORITY_OR_OTHER|||||||0.4543|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.4543
73906935|NCT01675427|147344287|SUPERIORITY_OR_OTHER|||||||0.0406|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.0406
73906936|NCT01675427|147344288|SUPERIORITY_OR_OTHER|||||||0.8234|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.8234
73906937|NCT01675427|147344288|SUPERIORITY_OR_OTHER|||||||0.2427|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.2427
73856358|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.88||||0.006|TWO_SIDED|95.0|0.55|3.21|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.21|0.55|0.006
74025723|NCT01982630|147604257|OTHER||Difference of Least Squares Means|6.02|||||TWO_SIDED|90.0|1.81|10.22|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||10.22|1.81|
74025724|NCT01982630|147604257|OTHER||Difference of Least Squares Means|1.5|||||TWO_SIDED|90.0|-2.65|5.64|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.64|-2.65|
74025725|NCT01982630|147604257|OTHER||Difference of Least Squares Means|-4.52|||||TWO_SIDED|90.0|-8.52|-0.52|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-0.52|-8.52|
74025726|NCT01982630|147604257|OTHER||Difference of Least Squares Means|1.73|||||TWO_SIDED|90.0|-2.38|5.83|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.83|-2.38|
73856359|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.29|||<|0.001|TWO_SIDED|95.0|0.94|3.63|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.63|0.94|<0.001
73856360|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.4|||<|0.001|TWO_SIDED|95.0|1.05|3.75|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.75|1.05|<0.001
73856361|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.78||||0.097|TWO_SIDED|95.0|-1.7|0.14|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.14|-1.70|0.097
73856362|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.52||||0.254|TWO_SIDED|95.0|-1.42|0.38|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.42|0.254
73856363|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.812|TWO_SIDED|95.0|-1.03|0.81|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-1.03|0.812
73856364|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32||||0.045|TWO_SIDED|95.0|0.03|2.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.61|0.03|0.045
73856365|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.59||||0.015|TWO_SIDED|95.0|0.31|2.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.87|0.31|0.015
73856366|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.73||||0.009|TWO_SIDED|95.0|0.43|3.02|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.02|0.43|0.009
73856367|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.08||||0.002|TWO_SIDED|95.0|0.78|3.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.37|0.78|0.002
73856368|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.76||||0.094|TWO_SIDED|95.0|-1.64|0.13|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-1.64|0.094
73856369|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.49||||0.269|TWO_SIDED|95.0|-1.35|0.38|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.35|0.269
73856370|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.35||||0.437|TWO_SIDED|95.0|-1.23|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-1.23|0.437
73856371|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.218|TWO_SIDED|95.0|-0.44|1.92|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.92|-0.44|0.218
73856372|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.19||||0.046|TWO_SIDED|95.0|0.02|2.35|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.35|0.02|0.046
74025727|NCT01982630|147604258|OTHER||Difference of Least Squares Means|-2.11|||||TWO_SIDED|90.0|-4.55|0.32|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||0.32|-4.55|
74025728|NCT01982630|147604258|OTHER||Difference of Least Squares Means|2.53|||||TWO_SIDED|90.0|-0.61|5.66|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.66|-0.61|
73906938|NCT01675427|147344288|SUPERIORITY_OR_OTHER|||||||0.4805|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.4805
73906939|NCT01675427|147344288|SUPERIORITY_OR_OTHER|||||||0.2901|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.2901
73906940|NCT01675427|147344288|SUPERIORITY_OR_OTHER|||||||0.3927|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.3927
73906941|NCT01675427|147344288|SUPERIORITY_OR_OTHER|||||||0.5769|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.5769
73906942|NCT00700570|147344291|SUPERIORITY_OR_OTHER|||||||0.1341|TWO_SIDED||||||Log Rank|||||||0.1341
73963788|NCT00520546|147463209|SUPERIORITY_OR_OTHER||negative prediction|33.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
73963789|NCT00520546|147463209|SUPERIORITY_OR_OTHER||sensitivity|73.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
73963790|NCT00520546|147463209|SUPERIORITY_OR_OTHER||specificity|31.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
73963791|NCT00520546|147463209|SUPERIORITY_OR_OTHER||accuracy|60.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
74025729|NCT01982630|147604258|OTHER||Difference of Least Squares Means|4.64|||||TWO_SIDED|90.0|1.35|7.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||7.93|1.35|
73906943|NCT00700570|147344293|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.0010
73906944|NCT01461980|147344323|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03||||||Diphtheria: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Diphtheria antigens).||1.03|0.86|
73906945|NCT01461980|147344323|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.85|0.99||||||Tetanus: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Tetanus antigens).||0.99|0.85|
73963792|NCT00520546|147463209|SUPERIORITY_OR_OTHER||positive prediction|96.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963793|NCT00520546|147463209|SUPERIORITY_OR_OTHER||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963794|NCT00520546|147463209|SUPERIORITY_OR_OTHER||sensitivity|87.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73906946|NCT01461980|147344324|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.85|1.02||||||Pertussis toxoid: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Pertussis toxoid).||1.02|0.85|
73906947|NCT01461980|147344324|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.84|0.98||||||Pertussis filamentous hemagglutinin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis filamentous hemagglutinin antigens).||0.98|0.84|
73906948|NCT01461980|147344324|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.98||||||Pertussis pertactin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis pertactin antigens).||0.98|0.80|
74025730|NCT01982630|147604259|OTHER||Difference of Least Squares Means|-0.65|||||TWO_SIDED|90.0|-5.01|3.71|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||3.71|-5.01|
73906949|NCT01461980|147344324|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.08||||||Pertussis fimbriae agglutinogens types 2 + 3: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis fimbriae agglutinogens types 2 + 3 antigens).||1.08|0.74|
74025731|NCT01982630|147604259|OTHER||Difference of Least Squares Means|-6.42|||||TWO_SIDED|90.0|-10.66|-2.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-2.19|-10.66|
73906950|NCT01461980|147344325|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.82|1.01||||||Serogroup A: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup A antigens).||1.01|0.82|
73906951|NCT01461980|147344325|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.9|1.15||||||Serogroup C: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup C antigens).||1.15|0.90|
73906952|NCT01461980|147344325|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.89|1.09||||||Serogroup Y: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup Y antigens).||1.09|0.89|
74025732|NCT01982630|147604259|OTHER||Difference of Least Squares Means|5.77|||||TWO_SIDED|90.0|1.57|9.97|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||9.97|1.57|
74025733|NCT01982630|147604259|OTHER||Difference of Least Squares Means|-0.15|||||TWO_SIDED|90.0|-4.29|4.0|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.00|-4.29|
74085111|NCT00407745|147723826|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.472||0.3123|TWO_SIDED|95.0|-1.42|0.46||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.46|-1.42|0.3123
73906953|NCT01461980|147344325|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04||||||Serogroup W-135: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup W-135 antigens).||1.04|0.83|
74085112|NCT00407745|147723826|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.368||0.136|TWO_SIDED|95.0|-1.28|0.18||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.18|-1.28|0.1360
73906954|NCT01461980|147344326|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.84|1.02||||||PMB80 \[A22\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).||1.02|0.84|
73906955|NCT01461980|147344326|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.82|1.0||||||PMB2948 \[B24\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).||1.00|0.82|
73930935|NCT00280566|147391709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.18||0.1666|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1666
74025734|NCT01982630|147604259|OTHER||Difference of Least Squares Means|-5.91|||||TWO_SIDED|90.0|-9.91|-1.92|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-1.92|-9.91|
74025735|NCT01982630|147604259|OTHER||Difference of Least Squares Means|0.51|||||TWO_SIDED|90.0|-3.6|4.62|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.62|-3.60|
73906956|NCT00631696|147344350|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A non-inferiority margin of 20% was used to test the hypothesis. The null hypothesis is that the difference (PGB - PBO) in the proportion of participants with ≥50% reduction in sperm concentration is ≥20% and the alternative hypothesis is that the difference in proportion of participant with ≥50% reduction in sperm concentration is \<20%.|percentage difference|6.0|||||TWO_SIDED|95.0|-2.29|14.3|||Confidence Interval Approach||The confidence interval was based on asymptotic normal distribution.|Study powered to show non-inferiority (NI) of pregabalin (PGB) to placebo (PBO) on the percentage of participants (N) with a ≥50% reduction in MSC from Bsl to end of washout (Week (Wk) 26, or last assessment on or after Wk 12 if Wk 26 not done). NI to be declared if upper bound of 95% CI for difference between PGB and PBO not \>20%. Assuming proportion of N with 50% reduction to be 6% for both groups, sample size N=65 per group would provide \>90% power to show NI of PGB to PBO.||14.30|-2.29|
73906957|NCT00631696|147344351|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12||||0.3462|TWO_SIDED|95.0|-0.385|0.136||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.136|-0.385|0.3462
73906958|NCT00631696|147344352|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13||||0.3652|TWO_SIDED|95.0|-0.42|0.156||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.156|-0.420|0.3652
73906959|NCT00631696|147344353|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.1204|TWO_SIDED|95.0|-0.464|0.054||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.054|-0.464|0.1204
73906960|NCT00631696|147344354|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|24.65||||0.2875|TWO_SIDED|95.0|-20.999|70.302||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||70.302|-20.999|0.2875
73906961|NCT00631696|147344355|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.93||||0.1699|TWO_SIDED|95.0|-14.292|80.158||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||80.158|-14.292|0.1699
73906962|NCT00631696|147344356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.12||||0.7958|TWO_SIDED|95.0|-52.804|40.558||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||40.558|-52.804|0.7958
73906963|NCT00631696|147344357|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08||||0.4094|TWO_SIDED|95.0|-3.645|1.494||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||1.494|-3.645|0.4094
73906964|NCT00631696|147344358|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15||||0.9064|TWO_SIDED|95.0|-2.649|2.352||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||2.352|-2.649|0.9064
73906965|NCT00631696|147344359|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.86||||0.4666|TWO_SIDED|95.0|-3.207|1.477||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||1.477|-3.207|0.4666
74025736|NCT01982630|147604260|OTHER||Difference of Least Squares Means|-0.89|||||TWO_SIDED|90.0|-3.8|2.02|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||2.02|-3.80|
73906966|NCT00943124|147344389|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.14||||||90.0|1.09|1.2||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.20|1.09|
73906967|NCT00943124|147344390|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.11||||||90.0|1.05|1.16||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.16|1.05|
73906968|NCT00943124|147344391|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.97||||||90.0|0.93|1.0||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.00|0.93|
73963795|NCT00520546|147463209|SUPERIORITY_OR_OTHER||specificity|92.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963796|NCT00520546|147463209|SUPERIORITY_OR_OTHER||accuracy|88.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963797|NCT00520546|147463210|SUPERIORITY_OR_OTHER||positive prediction|67.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
73856373|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.31||||0.03|TWO_SIDED|95.0|0.13|2.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.49|0.13|0.030
73856374|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.75||||0.004|TWO_SIDED|95.0|0.57|2.93|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.93|0.57|0.004
73856375|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.01||||0.014|TWO_SIDED|95.0|-1.82|-0.2|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.20|-1.82|0.014
73856376|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.56||||0.16|TWO_SIDED|95.0|-1.35|0.22|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-1.35|0.160
73856377|NCT01559259|147258983|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.44||||0.284|TWO_SIDED|95.0|-1.25|0.37|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.37|-1.25|0.284
73856378|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.62||||0.014|TWO_SIDED|95.0|0.13|1.1|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.13|0.014
73856379|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.46||||0.066|TWO_SIDED|95.0|-0.03|0.94|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.94|-0.03|0.066
73856380|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.71||||0.004|TWO_SIDED|95.0|0.22|1.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.20|0.22|0.004
73856381|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.3||||0.232|TWO_SIDED|95.0|-0.19|0.78|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|-0.19|0.232
73856382|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.32||||0.067|TWO_SIDED|95.0|-0.02|0.66|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.66|-0.02|0.067
73856383|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.354|TWO_SIDED|95.0|-0.18|0.5|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.18|0.354
73856384|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.017|TWO_SIDED|95.0|0.08|0.76|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.76|0.08|0.017
73856385|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.15|||<|0.001|TWO_SIDED|95.0|1.45|2.86|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.86|1.45|<0.001
73856386|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.93|||<|0.001|TWO_SIDED|95.0|1.23|2.64|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.64|1.23|<0.001
73856387|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.39|2.8|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.80|1.39|<0.001
73856388|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32|||<|0.001|TWO_SIDED|95.0|0.61|2.02|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.02|0.61|<0.001
74025737|NCT01982630|147604260|OTHER||Difference of Least Squares Means|5.24|||||TWO_SIDED|90.0|1.34|9.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||9.15|1.34|
74025738|NCT01982630|147604260|OTHER||Difference of Least Squares Means|6.13|||||TWO_SIDED|90.0|2.05|10.22|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||10.22|2.05|
73906969|NCT00943124|147344392|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.87|0.97||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.97|0.87|
73906970|NCT00943124|147344393|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.02||||||90.0|0.99|1.04||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.04|0.99|
73906971|NCT00943124|147344394|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.08||||||90.0|1.02|1.14||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.14|1.02|
73906972|NCT00943124|147344395|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.77||||||90.0|0.72|0.82||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.82|0.72|
73906973|NCT00943124|147344396|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.89|0.94||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.94|0.89|
73963798|NCT00520546|147463210|SUPERIORITY_OR_OTHER||negative prediction|69.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
73963799|NCT00520546|147463210|SUPERIORITY_OR_OTHER||sensitivity|86.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
73963800|NCT00520546|147463210|SUPERIORITY_OR_OTHER||specificity|43.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
73963801|NCT00520546|147463210|SUPERIORITY_OR_OTHER||accuracy|67.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
73963802|NCT00520546|147463210|SUPERIORITY_OR_OTHER||positive prediction|59.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
73963803|NCT00520546|147463210|SUPERIORITY_OR_OTHER||negative prediction|46.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
73963804|NCT00520546|147463210|SUPERIORITY_OR_OTHER||sensitivity|66.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
73963805|NCT00520546|147463210|SUPERIORITY_OR_OTHER||specificity|38.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
73963806|NCT00520546|147463210|SUPERIORITY_OR_OTHER||accuracy|54.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
73963807|NCT00520546|147463210|SUPERIORITY_OR_OTHER||positive prediction|86.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73906974|NCT02448810|147344398|OTHER||Hazard Ratio (HR)|0.8||||0.246|TWO_SIDED|70.0|0.5|1.1||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).|1.1|0.5|0.246
73906975|NCT02448810|147344398|OTHER||Hazard Ratio (HR)|0.8||||0.354|TWO_SIDED|70.0|0.5|1.4||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).|1.4|0.5|0.354
73963808|NCT00520546|147463210|SUPERIORITY_OR_OTHER||negative prediction|76.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963809|NCT00520546|147463210|SUPERIORITY_OR_OTHER||sensitivity|83.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963810|NCT00520546|147463210|SUPERIORITY_OR_OTHER||specificity|80.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73856389|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83|||<|0.001|TWO_SIDED|95.0|0.34|1.33|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.33|0.34|<0.001
73856390|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.62||||0.014|TWO_SIDED|95.0|0.12|1.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.11|0.12|0.014
73856391|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.77||||0.002|TWO_SIDED|95.0|0.28|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.27|0.28|0.002
73856392|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.45|||<|0.001|TWO_SIDED|95.0|2.69|4.22|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.22|2.69|<0.001
73856393|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.13|||<|0.001|TWO_SIDED|95.0|2.36|3.89|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.89|2.36|<0.001
73856394|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.49|||<|0.001|TWO_SIDED|95.0|2.72|4.26|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.26|2.72|<0.001
73856395|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.78|||<|0.001|TWO_SIDED|95.0|2.02|3.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.54|2.02|<0.001
73856396|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.67||||0.014|TWO_SIDED|95.0|0.14|1.21|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.21|0.14|0.014
73856397|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.35||||0.202|TWO_SIDED|95.0|-0.19|0.88|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.88|-0.19|0.202
73856398|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.71||||0.01|TWO_SIDED|95.0|0.17|1.24|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|0.17|0.010
73856399|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.0|||<|0.001|TWO_SIDED|95.0|3.24|4.76|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.76|3.24|<0.001
73856400|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.55|||<|0.001|TWO_SIDED|95.0|2.79|4.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.31|2.79|<0.001
73856401|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.03|||<|0.001|TWO_SIDED|95.0|3.27|4.79|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.79|3.27|<0.001
73906976|NCT03194503|147344416|SUPERIORITY||Odds Ratio (OR)|0.65||||0.015|TWO_SIDED|95.0|0.47|0.92|||t-test, 2 sided|||This statistical analysis applies to all three rows in the post-intervention column. ITT analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)||0.92|0.47|0.015
73906977|NCT03194503|147344417|SUPERIORITY||Odds Ratio (OR)|0.77||||0.25|TWO_SIDED|95.0|0.5|1.2|||t-test, 2 sided|||This statistical analysis applies to all three rows and is a per-protocol analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)||1.20|0.50|0.250
73906978|NCT04856891|147344437|SUPERIORITY||Percent Difference from Placebo|78.4|||<|0.0001|TWO_SIDED|95.0|62.2|89.1|||Fisher Exact|||||89.1|62.2|<0.0001
73906979|NCT04856891|147344438|SUPERIORITY||LSM Difference from Placebo|0.3||||0.8822|TWO_SIDED|95.0|-4.0|4.7|||Mixed Models Analysis|||||4.7|-4.0|0.8822
73906980|NCT04856891|147344439|SUPERIORITY||LSM Difference from Placebo|-74.9|||<|0.0001|TWO_SIDED|95.0|-85.2|-64.7|||ANCOVA|||||-64.7|-85.2|<0.0001
73856402|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.48|||<|0.001|TWO_SIDED|95.0|2.72|4.24|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.24|2.72|<0.001
73906981|NCT04856891|147344440|SUPERIORITY||Percent Difference from Placebo|80.4|||<|0.0001|TWO_SIDED|95.0|64.8|90.6|||Fisher Exact|||||90.6|64.8|<0.0001
73906982|NCT04856891|147344441|SUPERIORITY||Percent Difference from Placebo|43.5|||<|0.0001|TWO_SIDED|95.0|23.5|59.9|||Fisher Exact|||||59.9|23.5|<0.0001
73906983|NCT04856891|147344442|SUPERIORITY||Percent Difference from Placebo|-1.5||||1|TWO_SIDED|95.0|-22.2|18.0|||Fisher Exact|||||18.0|-22.2|1.0000
73906984|NCT04856891|147344443|SUPERIORITY||Percent Difference from Placebo|6.9||||0.4502|TWO_SIDED|95.0|-13.8|26.3|||Fisher Exact|||||26.3|-13.8|0.4502
73906985|NCT04856891|147344444|SUPERIORITY||LSM Difference from Placebo|-3.1||||0.6805|TWO_SIDED|95.0|-18.1|11.8|||Mixed Models Analysis|||Weeks 24 Percent Change from Baseline||11.8|-18.1|0.6805
73963811|NCT00520546|147463210|SUPERIORITY_OR_OTHER||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
73963812|NCT00595790|147463211|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of non-inferiority of IC51 1x12 mcg vs. IC51 2x6 mcg at Day 56 based on the difference (IC51 1x12 mcg - IC51 2x6 mcg) in SCRs in the PP population. Non-inferiority of IC51 1 x 12 mcg compared to IC51 2 x 6 mcg was accepted if the lower limit of the 95% CI of the adjusted for center SCR difference (IC51 1 x 12 mcg - IC51 2 x 6 mcg) was higher than the noninferiority margin at -10%.|||||>|0.99|||||||Mantel Haenszel|||||||>0.99
73963813|NCT00296036|147463233|SUPERIORITY_OR_OTHER|||||||0.768|||||||Fisher Exact|||||||0.768
73963814|NCT00895531|147463238|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
73963815|NCT04452318|147463243|SUPERIORITY||Odds Ratio (OR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.09|0.332|||Regression, Logistic|||||0.332|0.090|< 0.0001
73963816|NCT04452318|147463244|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.038|TWO_SIDED|95.0|0.298|0.966|||Regression, Logistic|||||0.966|0.298|= 0.0380
73963817|NCT04452318|147463246|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.069|0.236|||Regression, Logistic|||||0.236|0.069|< 0.0001
74085113|NCT00407745|147723827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.549||0.4257|TWO_SIDED|95.0|-1.53|0.65||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.65|-1.53|0.4257
73963818|NCT04452318|147463246|SUPERIORITY||Odds Ratio (OR)|0.41|||=|0.0024|TWO_SIDED|95.0|0.228|0.728|||Regression, Logistic|||||0.728|0.228|= 0.0024
73963819|NCT04452318|147463247|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
73963820|NCT04452318|147463248|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
73906986|NCT00413400|147344532|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||ANCOVA|||treatment effect (etanercept vs. placebo) using ANCOVA including baseline CRP, age, and race||||0.20
73963821|NCT04452318|147463248|SUPERIORITY||||||=|0.001|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0010
73906987|NCT00413400|147344533|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Repeated Measures ANCOVA|||within subject percent changes calculated for each timepoint and repeated measures ANCOVA controlling for age and race performed||||0.92
73906988|NCT00413400|147344534|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Repeated Measures ANCOVA|||within subject percent changes were calculated for each time point, then repeated measures ANCOVA controlling for age and race performed||||0.02
73906989|NCT00413400|147344535|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||repeated measures ANCOVA|||percent change calculated then repeated measures ANCOVA performed controlling for age and race||||0.02
73906990|NCT00413400|147344536|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, race||||0.46
73963822|NCT04452318|147463249|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
73906991|NCT00413400|147344537|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||||||0.78
73906992|NCT00413400|147344538|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
73963823|NCT04452318|147463250|SUPERIORITY||Odds Ratio (OR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.208|0.456|||Multiple Imputation, Logistic Regression|||||0.456|0.208|< 0.0001
73963824|NCT04452318|147463252|SUPERIORITY||Odds Ratio (OR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.051|0.286|||Regression, Logistic|||||0.286|0.051|< 0.0001
73963825|NCT04452318|147463253|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
73963826|NCT04452318|147463254|SUPERIORITY||Odds Ratio (OR)|0.09|||=|0.001|TWO_SIDED|95.0|0.02|0.37|||Regression, Logistic|||||0.370|0.020|= 0.0010
73963827|NCT04452318|147463255|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
73963828|NCT04452318|147463258|SUPERIORITY||Difference of LS Means|-2.123|STANDARD_ERROR_OF_MEAN|0.295|<|0.0001|TWO_SIDED|95.0|-2.707|-1.539|||ANOVA|||||-1.539|-2.707|< 0.0001
73963829|NCT04452318|147463259|SUPERIORITY||Difference of LS Means|-2.483|STANDARD_ERROR_OF_MEAN|0.342|<|0.0001|TWO_SIDED|95.0|-3.161|-1.806|||ANOVA|||||-1.806|-3.161|< 0.0001
73963830|NCT04452318|147463260|SUPERIORITY||Difference of LS Mean|-2.428|STANDARD_ERROR_OF_MEAN|0.389|<|0.0001|TWO_SIDED|95.0|-3.196|-1.659|||ANOVA|||||-1.659|-3.196|< 0.0001
73963831|NCT04452318|147463261|SUPERIORITY||Difference of LS Mean|-2.441|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.194|-1.688|||ANOVA|||||-1.688|-3.194|< 0.0001
73963832|NCT04452318|147463264|OTHER||||||=|0.0621|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.0621
73963833|NCT04452318|147463265|OTHER||||||=|0.0038|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received'||||= 0.0038
73963834|NCT04452318|147463268|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
73963835|NCT04452318|147463276|SUPERIORITY||||||=|0.0273|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0273
73963836|NCT04452318|147463277|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.046|TWO_SIDED|95.0|0.299|0.989|||Regression, Logistic|||||0.989|0.299|= 0.0460
73963837|NCT04452318|147463278|SUPERIORITY||Odds Ratio (OR)|0.47|||=|0.0721|TWO_SIDED|95.0|0.207|1.07|||Regression, Logistic|||||1.070|0.207|= 0.0721
73856403|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.52||||0.056|TWO_SIDED|95.0|-0.01|1.05|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.05|-0.01|0.056
73856404|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.789|TWO_SIDED|95.0|-0.46|0.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.60|-0.46|0.789
73856405|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.042|TWO_SIDED|95.0|0.02|1.08|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|0.02|0.042
73856406|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.17|||<|0.001|TWO_SIDED|95.0|3.37|4.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.98|3.37|<0.001
73856407|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.86|||<|0.001|TWO_SIDED|95.0|3.06|4.66|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.66|3.06|<0.001
73856408|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.34|||<|0.001|TWO_SIDED|95.0|3.54|5.14|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.14|3.54|<0.001
73856409|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|3.09|4.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.69|3.09|<0.001
73856410|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.317|TWO_SIDED|95.0|-0.28|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.85|-0.28|0.317
73856411|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.922|TWO_SIDED|95.0|-0.59|0.53|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-0.59|0.922
73856412|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.112|TWO_SIDED|95.0|-0.11|1.02|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|-0.11|0.112
73906993|NCT00413400|147344539|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, race||||0.59
73856413|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.1|||<|0.001|TWO_SIDED|95.0|3.27|4.94|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.94|3.27|<0.001
73856414|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.76|||<|0.001|TWO_SIDED|95.0|2.92|4.59|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.59|2.92|<0.001
73856415|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.15|||<|0.001|TWO_SIDED|95.0|3.32|4.99|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.99|3.32|<0.001
73856416|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|3.05|4.72|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.72|3.05|<0.001
73856417|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.464|TWO_SIDED|95.0|-0.37|0.81|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-0.37|0.464
73856418|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.13||||0.667|TWO_SIDED|95.0|-0.71|0.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.71|0.667
73856419|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.368|TWO_SIDED|95.0|-0.32|0.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.32|0.368
73856420|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.94|||<|0.001|TWO_SIDED|95.0|3.08|4.81|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.81|3.08|<0.001
73856421|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.63|||<|0.001|TWO_SIDED|95.0|2.77|4.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.49|2.77|<0.001
73856422|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.06|||<|0.001|TWO_SIDED|95.0|3.19|4.92|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.92|3.19|<0.001
73856423|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.68|||<|0.001|TWO_SIDED|95.0|2.82|4.54|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.54|2.82|<0.001
73906994|NCT00413400|147344540|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Repeated measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA controlling for age and race performed||||<0.0001
73906995|NCT00413400|147344541|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Repeated Measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA performed controlling for age and race||||0.08
73906996|NCT00413400|147344542|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, and race||||0.55
73906997|NCT00891462|147344544|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.086|||<|0.0001|TWO_SIDED|95.0|0.05|0.13|||ANCOVA|||||0.13|0.05|<0.0001
73906998|NCT00891462|147344544|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.124|||<|0.0001|TWO_SIDED|95.0|0.08|0.16|||ANCOVA|||||0.16|0.08|<0.0001
73906999|NCT00257608|147344562|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.708||||0.0006|TWO_SIDED|95.0|0.58|0.864|||Log Rank|||||0.864|0.580|0.0006
73907000|NCT00257608|147344568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917||||0.5341|TWO_SIDED|95.0|0.698|1.205|||Log Rank|||||1.205|0.698|0.5341
73907001|NCT01193660|147344604|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|2.59|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
73907002|NCT01193660|147344605|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|3.94|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MENTAL Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
73907003|NCT01193660|147344606|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|2.7|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MOTOR Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
73907004|NCT01193660|147344608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||The baseline and post-therapy data of each group were compared using paired t-test statistics.|t-test, 2 sided|Voxels with an uncorrected p-value of \<0.05 were considered significant, and an extent threshold Ke of 100 voxels was set by SPM implanted in Matlab.||In our analysis, the null hypothesis is that the effects of three experimental groups are same each other, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) has much higher than that of either Erythropoietin + Rehabilitation Group or Rehabilitation Group. This study is a pilot study and therefore, power calculation was not applicable in our study. The sample size of each group is more than 30.||||0.05
73907005|NCT01193660|147344610|SUPERIORITY_OR_OTHER_LEGACY||interaction of group and visit|0.9|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
73907006|NCT01193660|147344611|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|1.279|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
73907007|NCT01193660|147344612|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|0.996|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
73907008|NCT01193660|147344613|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|0.56|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
73907009|NCT01193660|147344614|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Fisher Exact|We compared the ratio of participants with a certain adverse event (AE) and without the AE between three groups using Fisher Exact test.||||||<0.05
73907010|NCT00195273|147344615|SUPERIORITY_OR_OTHER|||||||0.6081||||||Calculated for 12 month analysis|ANOVA|Analysis of variance with treatment group and center as factors||||||0.6081
73907011|NCT00195273|147344618|SUPERIORITY_OR_OTHER|||||||0.4662|||||||ANOVA|Calculated for 3 month analysis||||||0.4662
73907012|NCT02595970|147344622|SUPERIORITY|adjusted for multiplicity using the Hochberg procedure.|Mean Difference (Net)|-22.6|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-24.52|20.59|||t-test, 2 sided|||||20.59|-24.52|<0.0001
73907013|NCT02595970|147344632|SUPERIORITY|adjusted|Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-23.52|19.58|||t-test, 2 sided|||||19.58|-23.52|<0.0001
73907014|NCT01973569|147344655|SUPERIORITY|||||||0.0235||||||The hierarchical testing procedure was applied for multiple comparisons of the primary endpoint. First, comparison between AMG 162 60mg Q3M vs placebo is tested. Only if it is rejected, comparison of AMG 162 60mg Q6M vs placebo is formally tested.|van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0235
73907015|NCT01973569|147344656|SUPERIORITY|||||||0.036|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0360
73907016|NCT01973569|147344657|SUPERIORITY|||||||0.1323|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.1323
73907017|NCT01973569|147344658|SUPERIORITY|||||||0.0448|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0448
73907018|NCT01973569|147344659|SUPERIORITY|||||||0.0104|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0104
73907019|NCT01973569|147344660|SUPERIORITY|||||||0.257|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.2570
73907020|NCT01973569|147344661|SUPERIORITY||Mean Difference (Net)|5.02|||<|0.0001|TWO_SIDED|95.0|4.41|5.63|||Regression, Cox|ANCOVA model adjusting for treatment, baseline (BL) value, machine type, BL value-by-machine type interaction, and BL use of glucocorticoid was used.||||5.63|4.41|<0.0001
73907021|NCT00810108|147344666|NON_INFERIORITY_OR_EQUIVALENCE|The geometric mean and 90% confidence interval assessed whether the crushed and whole tablet administration AUCs were equivalent.|Ratio of Crushed/Whole Tablet AUC|0.55|||<|0.05|TWO_SIDED|90.0|0.45|0.69|||t-test, 2 sided|||Lopinavir AUC was compared between whole tablet and crushed tablet administration by using a ratio of crushed/whole AUC.||0.69|0.45|<0.05
73907022|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.28|-0.57|||ANCOVA|||Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.28|<0.001
73907023|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
74025739|NCT01982630|147604261|OTHER||Difference of Least Squares Means|-0.57|||||TWO_SIDED|90.0|-3.71|2.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||2.57|-3.71|
73907024|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|-0.94|-0.23|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.94|0.001
73856424|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.26||||0.397|TWO_SIDED|95.0|-0.34|0.86|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.34|0.397
74025740|NCT01982630|147604261|OTHER||Difference of Least Squares Means|7.77|||||TWO_SIDED|90.0|3.5|12.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.03|3.50|
74025741|NCT01982630|147604261|OTHER||Difference of Least Squares Means|8.34|||||TWO_SIDED|90.0|3.89|12.79|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.79|3.89|
73856425|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.866|TWO_SIDED|95.0|-0.65|0.55|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.55|-0.65|0.866
73907025|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.015|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.81|0.015
73907026|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.453|TWO_SIDED|95.0|-0.49|0.22|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.49|0.453
73907027|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.18||0.177|TWO_SIDED|95.0|-0.61|0.11|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.61|0.177
73907028|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.062|TWO_SIDED|95.0|-0.7|0.02|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.70|0.062
73907029|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.212|TWO_SIDED|95.0|-0.59|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.59|0.212
73907030|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.34|-0.54|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.54|-1.34|<0.001
73907031|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.15|-0.35|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.35|-1.15|<0.001
73907032|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.2||0.004|TWO_SIDED|95.0|-0.98|-0.18|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.98|0.004
74025742|NCT01982630|147604262|OTHER||Difference of Least Squares Means|1.35|||||TWO_SIDED|90.0|-2.4|5.09|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.09|-2.40|
74025743|NCT01982630|147604262|OTHER||Difference of Least Squares Means|8.29|||||TWO_SIDED|90.0|3.29|13.3|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||13.30|3.29|
73907033|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.95|-0.15|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.95|0.007
73907034|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.2||0.879|TWO_SIDED|95.0|-0.43|0.37|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.37|-0.43|0.879
73856426|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.226|TWO_SIDED|95.0|-0.23|0.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.97|-0.23|0.226
73856427|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.8|||<|0.001|TWO_SIDED|95.0|2.9|4.7|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.70|2.90|<0.001
73856428|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.37|||<|0.001|TWO_SIDED|95.0|2.47|4.26|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.26|2.47|<0.001
73856429|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|2.99|4.79|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.79|2.99|<0.001
73856430|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.6|||<|0.001|TWO_SIDED|95.0|2.7|4.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.50|2.70|<0.001
73856431|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.536|TWO_SIDED|95.0|-0.43|0.83|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.83|-0.43|0.536
73907035|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.60|0.330
73907036|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.083|TWO_SIDED|95.0|-0.75|0.05|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.75|0.083
73907037|NCT00809354|147344738|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.36|TWO_SIDED|95.0|-0.59|0.21|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.59|0.360
73907038|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.23|-0.53|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.23|<0.001
73907039|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.13|-0.43|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.13|<0.001
73907040|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.003|TWO_SIDED|95.0|-0.87|-0.17|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.87|0.003
73907041|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.007|TWO_SIDED|95.0|-0.83|-0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.83|0.007
73907042|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.18||0.824|TWO_SIDED|95.0|-0.39|0.31|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.39|0.824
73907043|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.18||0.1|TWO_SIDED|95.0|-0.64|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.64|0.100
73907044|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.044|TWO_SIDED|95.0|-0.7|-0.01|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.70|0.044
73907045|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.565|TWO_SIDED|95.0|-0.45|0.25|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.45|0.565
73907046|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.4|-0.62|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.62|-1.40|<0.001
73907047|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.2|-0.42|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.20|<0.001
73856432|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.467|TWO_SIDED|95.0|-0.86|0.39|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.86|0.467
73907048|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.02|-0.24|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-1.02|0.002
73963838|NCT04452318|147463279|SUPERIORITY||||||=|0.026|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0260
73856433|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.361|TWO_SIDED|95.0|-0.34|0.92|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.92|-0.34|0.361
73963839|NCT04452318|147463280|SUPERIORITY||||||=|0.0614|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0614
73963840|NCT04452318|147463281|SUPERIORITY||LS mean difference|-1.461|STANDARD_ERROR_OF_MEAN|0.337|<|0.0001|TWO_SIDED|95.0|-2.127|-0.795|||ANCOVA|||||-0.795|-2.127|< 0.0001
73963841|NCT04452318|147463282|SUPERIORITY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.279|=|0.0026|TWO_SIDED|95.0|-1.4|-0.3|||ANCOVA|||||-0.300|-1.400|= 0.0026
73963842|NCT04452318|147463283|SUPERIORITY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|-1.321|-0.559|||ANCOVA|||||-0.559|-1.321|< 0.0001
73963843|NCT04452318|147463284|SUPERIORITY||Difference of LS Mean|-26.045|STANDARD_ERROR_OF_MEAN|6.041|<|0.0001|TWO_SIDED|95.0|-37.973|-14.117|||ANCOVA|||||-14.117|-37.973|< 0.0001
73963844|NCT04452318|147463285|SUPERIORITY||Difference of LS Mean|-1.395|STANDARD_ERROR_OF_MEAN|0.338|<|0.0001|TWO_SIDED|95.0|-2.063|-0.727|||ANCOVA|||||-0.727|-2.063|< 0.0001
73963845|NCT04452318|147463286|SUPERIORITY||||||=|0.0138|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0138
73963846|NCT04452318|147463287|OTHER||||||=|0.0292|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.0292
73963847|NCT04452318|147463288|OTHER||||||=|0.2466|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.2466
73856434|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.17|||<|0.001|TWO_SIDED|95.0|2.21|4.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.13|2.21|<0.001
73963848|NCT04452318|147463289|SUPERIORITY||||||=|0.7861|||||||Stratified Wilcoxon Rank Sum test|||||||= 0.7861
73963849|NCT04452318|147463290|SUPERIORITY||||||=|0.0842|||||||Stratified Wilcoxon Rank Sum test|||||||= 0.0842
73963850|NCT04583423|147463325|OTHER||Difference in Percentages|10.4||||0.3504|TWO_SIDED|95.0|-13.4|35.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50-mg MK-3655 minus % placebo|||35.1|-13.4|0.3504
73963851|NCT04583423|147463325|OTHER||Difference in Percentages|9.2||||0.373|TWO_SIDED|95.0|-15.6|32.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100-mg MK-3655 minus % placebo|||32.1|-15.6|0.3730
73963852|NCT04583423|147463325|OTHER||Difference in Percentages|15.4||||0.1428|TWO_SIDED|95.0|-8.5|42.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 300-mg MK-3655 minus % placebo|||42.3|-8.5|0.1428
73856435|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.04|3.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.95|2.04|<0.001
73856436|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.51|||<|0.001|TWO_SIDED|95.0|2.55|4.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.47|2.55|<0.001
73963853|NCT04583423|147463328|OTHER||Difference in Least Square (LS) Means|19.1|||||TWO_SIDED|95.0|1.7|36.4|||||Difference=LS Mean 50 mg minus LS Mean Placebo|||36.4|1.7|
73963854|NCT04583423|147463328|OTHER||Difference in LS Means|19.0|||||TWO_SIDED|95.0|2.2|35.8|||||Difference=LS Mean 100 mg minus LS Mean Placebo|||35.8|2.2|
73963855|NCT04583423|147463328|OTHER||Difference in LS Means|26.1|||||TWO_SIDED|95.0|9.5|42.8|||||Difference=LS Mean 300 mg minus LS Mean Placebo|||42.8|9.5|
73963856|NCT04583423|147463329|OTHER||Difference in Percentages|1.6||||0.8978|TWO_SIDED|95.0|-26.5|30.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50 mg minus % Placebo|||30.3|-26.5|0.8978
73963857|NCT04583423|147463329|OTHER||Difference in Parentages|20.0||||0.1869|TWO_SIDED|95.0|-10.6|46.4|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100 mg minus % Placebo|||46.4|-10.6|0.1869
73963858|NCT04583423|147463329|OTHER||Difference in Percentages|8.5||||0.5636|TWO_SIDED|95.0|-22.1|38.5|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 300 mg minus % Placebo|||38.5|-22.1|0.5636
73963859|NCT04583423|147463330|OTHER||Difference in Percentages|1.6||||0.9174|TWO_SIDED|95.0|-28.6|32.6|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50 mg minus % Placebo|||32.6|-28.6|0.9174
73963860|NCT04583423|147463330|OTHER||Difference in Percentages|18.5||||0.272|TWO_SIDED|95.0|-14.5|47.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100 mg minus % Placebo|||47.1|-14.5|0.2720
73963861|NCT04583423|147463330|OTHER||Difference in Percentages|5.3||||0.7586|TWO_SIDED|95.0|-26.7|37.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference= % 300 mg minus % Placebo|||37.3|-26.7|0.7586
73963862|NCT01198145|147463331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
73963863|NCT01198145|147463332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Chi-squared|||Comparing Tenesmus During RT||||0.23
73963864|NCT01198145|147463332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||Chi-squared|||Comparing Tenesmus after RT||||0.64
73963865|NCT01198145|147463332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Chi-squared|||Comparing abdominal pain during RT.||||0.30
73963866|NCT01198145|147463332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||Comparing abdominal pain after RT||||0.02
73963867|NCT01198145|147463332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Chi-squared|||Comparing constipation during RT||||0.70
73963868|NCT01198145|147463332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|||||||Chi-squared|||Comparing constipation after RT||||0.63
73963869|NCT01198145|147463332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Chi-squared|||Comparing diarrhea during RT||||0.44
74085114|NCT00407745|147723827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.412||0.2005|TWO_SIDED|95.0|-1.34|0.28||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.28|-1.34|0.2005
73856437|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.04|||<|0.001|TWO_SIDED|95.0|2.09|4.0|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.00|2.09|<0.001
73856438|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.704|TWO_SIDED|95.0|-0.54|0.8|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.80|-0.54|0.704
73856439|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.89|TWO_SIDED|95.0|-0.71|0.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.62|-0.71|0.890
73856440|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.17|TWO_SIDED|95.0|-0.2|1.14|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.14|-0.20|0.170
73856441|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.69|||<|0.001|TWO_SIDED|95.0|1.72|3.67|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.67|1.72|<0.001
73856442|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.58|||<|0.001|TWO_SIDED|95.0|1.61|3.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.56|1.61|<0.001
73856443|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.01|3.97|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.97|2.01|<0.001
73856444|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.75|||<|0.001|TWO_SIDED|95.0|1.77|3.72|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.72|1.77|<0.001
73856445|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.882|TWO_SIDED|95.0|-0.74|0.63|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.63|-0.74|0.882
73856446|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.16||||0.64|TWO_SIDED|95.0|-0.84|0.52|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|-0.84|0.640
73856447|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.24||||0.482|TWO_SIDED|95.0|-0.44|0.93|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.93|-0.44|0.482
73856448|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.06|||<|0.001|TWO_SIDED|95.0|1.07|3.06|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.06|1.07|<0.001
73856449|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.17|3.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.16|1.17|<0.001
73856450|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.24|||<|0.001|TWO_SIDED|95.0|1.25|3.24|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.24|1.25|<0.001
73907049|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.02|-0.24|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-1.02|0.002
73963870|NCT01198145|147463332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|||||||Chi-squared|||Comparing diarrhea after RT||||0.48
73856451|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.42|||<|0.001|TWO_SIDED|95.0|1.43|3.41|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.41|1.43|<0.001
73856452|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.36||||0.314|TWO_SIDED|95.0|-1.05|0.34|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-1.05|0.314
73856453|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.469|TWO_SIDED|95.0|-0.95|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.44|-0.95|0.469
73856454|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.616|TWO_SIDED|95.0|-0.87|0.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|-0.87|0.616
73963871|NCT01198145|147463332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|||||||Chi-squared|||Comparing rectal bleeding during RT||||0.38
73963872|NCT01198145|147463332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Chi-squared|||||||0.15
73963873|NCT01198145|147463333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II during RT.||||0.56
73963874|NCT01198145|147463333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II after RT.||||0.74
73963875|NCT00603954|147463359|SUPERIORITY|||||||0.508|||||||Multivariate Cox models|||||||0.508
73963876|NCT00603954|147463359|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||At day 180||||0.02
73963877|NCT00603954|147463359|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||At Day 365||||0.002
74025744|NCT01982630|147604262|OTHER||Difference of Least Squares Means|6.95|||||TWO_SIDED|90.0|1.69|12.2|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.20|1.69|
74085115|NCT00407745|147723828|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.025||0.1377|TWO_SIDED|95.0|-0.09|0.01||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - 12 Items Total Intensity Score as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.01|-0.09|0.1377
73963878|NCT00603954|147463360|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||At day 100||||0.09
73963879|NCT00603954|147463360|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||At Day 40||||0.03
74025745|NCT01982630|147604263|OTHER||Difference of Least Squares Means|2.46|||||TWO_SIDED|90.0|-1.42|6.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||6.34|-1.42|
74025746|NCT01982630|147604263|OTHER||Difference of Least Squares Means|9.61|||||TWO_SIDED|90.0|4.42|14.81|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||14.81|4.42|
74025747|NCT01982630|147604263|OTHER||Difference of Least Squares Means|7.15|||||TWO_SIDED|90.0|1.7|12.6|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.60|1.70|
73963880|NCT00603954|147463360|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||At Day 180||||0.01
73963881|NCT00603954|147463361|SUPERIORITY|||||||0.0165|||||||Multivariate Cox models|||||||0.0165
73963882|NCT00603954|147463361|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|||||Mutivariate|||||||0.010
73963883|NCT00603954|147463361|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0495|TWO_SIDED|95.0|||||Multivariate|||||||0.0495
73963884|NCT00603954|147463361|SUPERIORITY||Hazard Ratio (HR)|3.8||||0.001|TWO_SIDED|95.0|||||Multivariate|||||||0.001
73963885|NCT00603954|147463362|SUPERIORITY|||||||0.15|||||||Fisher Exact|||19 of 49 Flu-TBI patients (39%) versus 25 of 45 TLI ATG patients (56%) had a least one episode of bacterial infection the first 100 days after transplantation (P = 0.15).||||0.15
73963886|NCT00603954|147463362|SUPERIORITY|||||||0.19|||||||Fisher Exact|||For fungal infections, the figures were 3 of 45 (6%) and 7 of 45 (16%), respectively (P = 0.19)||||0.19
73963887|NCT00603954|147463362|SUPERIORITY|||||||0.12|||||||Fisher Exact|||Among CMV-seropositive patients and/or donors, the 100-day cumulative incidence of CMV reactivation was 31% in Flu-TBI patients versus 47% in TLI-ATG patient||||0.12
73963888|NCT00603954|147463363|SUPERIORITY||Multivariate Cox models|2.3|STANDARD_DEVIATION|0.02||0.017|TWO_SIDED|95.0|1.1|4.7|||Cumulative incidence curves|||Four-year cumulative incidences of relapse/progression were 22% and 50% in Flu-TBI and TLI-ATG patients, respectively||4.7|1.1|0.017
73963889|NCT00603954|147463364|SUPERIORITY||Median Difference (Final Values)|4.0|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 0||||
73963890|NCT00603954|147463364|SUPERIORITY||Mean Difference (Final Values)|2.2|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 3||||
73963891|NCT00603954|147463364|SUPERIORITY||Mean Difference (Final Values)|0.95|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 10||||
73963892|NCT00603954|147463365|SUPERIORITY|||||||0.5|||||||Cumulative incidence curve|||||||0.5
73963893|NCT00603954|147463366|SUPERIORITY||multivariate analyses|2.0|STANDARD_DEVIATION|0.07||0.14|TWO_SIDED|95.0|1.0|4.1|||Kaplan-Meier method|||||4.1|1|0.14
73963894|NCT00603954|147463368|SUPERIORITY||multivariate analyses|1.2|STANDARD_DEVIATION|0.02||0.9|TWO_SIDED|95.0|1.0|1.4|||Kaplan-Meier method|||||1.4|1|0.9
73963895|NCT00603954|147463369|SUPERIORITY||multivariate analyses|1.2|STANDARD_DEVIATION|0.02||0.96|TWO_SIDED|95.0|1.0|1.4|||Kaplan-Meier method|||||1.4|1|0.96
73963896|NCT01736215|147463371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.343||||0.266|TWO_SIDED|95.0|0.052|2.261||The binary logistic regression analysis was performed using a crude model between predictor variable endogenous EPO (EPO less than or equal to 45.2 and EPO greater than 45.3)|Regression, Logistic|||||2.261|0.052|0.266
73963897|NCT01736215|147463372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.125||||0.05|TWO_SIDED|95.0|0.016|0.999||The binary logistic regression analysis was performed using a crude model between predictor variable CRP (CRP less than or equal to 10.3 and CRP greater than 10.4)|Regression, Logistic|||||0.999|0.016|0.05
73856455|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57||||0.002|TWO_SIDED|95.0|0.57|2.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.56|0.57|0.002
73856456|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.54||||0.002|TWO_SIDED|95.0|0.55|2.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.53|0.55|0.002
73856457|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.95|||<|0.001|TWO_SIDED|95.0|0.95|2.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.94|0.95|<0.001
73856458|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.91|||<|0.001|TWO_SIDED|95.0|0.92|2.9|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.90|0.92|<0.001
73856459|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.34||||0.33|TWO_SIDED|95.0|-1.04|0.35|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-1.04|0.330
73856460|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.37||||0.288|TWO_SIDED|95.0|-1.06|0.32|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-1.06|0.288
73856461|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.916|TWO_SIDED|95.0|-0.66|0.73|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.73|-0.66|0.916
73856462|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.01||||0.041|TWO_SIDED|95.0|0.04|1.98|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|0.04|0.041
73856463|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.05||||0.034|TWO_SIDED|95.0|0.08|2.01|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.01|0.08|0.034
73856464|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.59||||0.001|TWO_SIDED|95.0|0.62|2.56|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.56|0.62|0.001
73907050|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.2||0.98|TWO_SIDED|95.0|-0.39|0.4|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.40|-0.39|0.980
73907051|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.383|TWO_SIDED|95.0|-0.56|0.22|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.56|0.383
73907052|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.2||0.057|TWO_SIDED|95.0|-0.77|0.01|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.77|0.057
73907053|NCT00809354|147344739|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.312|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.59|0.312
73907054|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.008|TWO_SIDED|95.0|-0.32|-0.05|||ANCOVA|||Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.32|0.008
73907055|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.251|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.22|0.251
73907056|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.251|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.22|0.251
73907057|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.961|TWO_SIDED|95.0|-0.14|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.14|0.961
73907058|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.272|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.272
73856465|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.48||||0.003|TWO_SIDED|95.0|0.52|2.45|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.45|0.52|0.003
73856466|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.47||||0.171|TWO_SIDED|95.0|-1.15|0.2|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-1.15|0.171
73856467|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.44||||0.201|TWO_SIDED|95.0|-1.11|0.23|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-1.11|0.201
73856468|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.763|TWO_SIDED|95.0|-0.57|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|-0.57|0.763
73907059|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.271|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.271
73907060|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.128
73907061|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.133|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.133
73907062|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.35|0.002
73907063|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.34|-0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.34|0.004
73907064|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.414|TWO_SIDED|95.0|-0.2|0.08|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.20|0.414
73907065|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.057|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.057
73907066|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.277|TWO_SIDED|95.0|-0.06|0.21|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.06|0.277
73907067|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.328|TWO_SIDED|95.0|-0.21|0.07|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.21|0.328
73907068|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.026|TWO_SIDED|95.0|-0.3|-0.02|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.30|0.026
73963898|NCT00419341|147463397|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of SCIG:IVIG treatment was concluded if the lower GMR confidence limit was 0.8 or more. With 18 evaluable subjects, the power to show this non-inferiority was calculated to be 85% based on the assumptions of an intra-individual variability with a coefficient of variation (CV) = 25% and a GMR equal to or greater than 1.|Geometric mean ratio (GMR)|1.002|||||TWO_SIDED|90.0|0.951|1.055||No P-value is provided as non-inferiority was assessed by the CI of the GMR.|t-test, 2 sided|Based on log-transformed individual differences.|Geometric mean ratio SCIG:IVIG non-inferiority was concluded if the lower GMR confidence limit was 0.8 or more|Individual sAUC values (standardized to a 7-day period) of the IV and adjusted SC sampling periods in each individual subject were log transformed and a parametric 2-sided 90% confidence interval (CI) for the mean of the individual differences was obtained. Back-transformation of the mean and its CI produced the geometric mean ratio (GMR) and its respective 90% CI.||1.055|0.951|
73963899|NCT02020252|147463442|SUPERIORITY|||||||0.307||||||This is for the receptivity sub-scale, and the comparison between pre and post-test scores.|t-test, 2 sided|This was a paired t-test.||||||.307
73963900|NCT02020252|147463442|SUPERIORITY|||||||0.009||||||This is for the willingness sub-scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||.009
73963901|NCT02020252|147463442|SUPERIORITY||||||<|0.001||||||This is for knowledge sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|A paired t-test.||||||<.001
73907069|NCT00809354|147344740|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.864|TWO_SIDED|95.0|-0.15|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.15|0.864
73907070|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.16||0.927|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.31|0.927
73907071|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.057|TWO_SIDED|95.0|-0.64|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.64|0.057
73907072|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.779|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.37|0.779
73907073|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.16||0.798|TWO_SIDED|95.0|-0.36|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.36|0.798
73907074|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.98|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.980
73907075|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.16||0.098|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.60|0.098
73907076|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.26|0.709
73963902|NCT02020252|147463442|SUPERIORITY|||||||0.004||||||This is for the positive attitudes sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||.004
73963903|NCT02020252|147463442|SUPERIORITY||||||<|0.001||||||This was for the self-efficacy sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||<.001
73963904|NCT02539225|147463508|SUPERIORITY|||||||0.698|||||||Stratified Log Rank|||||||0.698
73963905|NCT02539225|147463509|SUPERIORITY|||||||0.549|||||||Log Rank Stratified|||||||0.549
73856469|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.66||||0.175|TWO_SIDED|95.0|-0.3|1.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.61|-0.30|0.175
73856470|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.75||||0.12|TWO_SIDED|95.0|-0.2|1.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|-0.20|0.120
73856471|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.19||||0.014|TWO_SIDED|95.0|0.24|2.15|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.15|0.24|0.014
73856472|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.31||||0.007|TWO_SIDED|95.0|0.36|2.26|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.26|0.36|0.007
73856473|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.66||||0.054|TWO_SIDED|95.0|-1.32|0.01|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.01|-1.32|0.054
73856474|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.56||||0.096|TWO_SIDED|95.0|-1.22|0.1|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.10|-1.22|0.096
73856475|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.12||||0.724|TWO_SIDED|95.0|-0.79|0.55|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.55|-0.79|0.724
73856476|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.345|TWO_SIDED|95.0|-0.46|1.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|-0.46|0.345
73856477|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.54||||0.228|TWO_SIDED|95.0|-0.34|1.41|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|-0.34|0.228
73856478|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.9||||0.045|TWO_SIDED|95.0|0.02|1.78|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|0.02|0.045
73907077|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.045|TWO_SIDED|95.0|0.01|0.65|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.65|0.01|0.045
73856479|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.08||||0.016|TWO_SIDED|95.0|0.21|1.96|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.96|0.21|0.016
73856480|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.66||||0.036|TWO_SIDED|95.0|-1.27|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-1.27|0.036
73856481|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54||||0.081|TWO_SIDED|95.0|-1.15|0.07|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.07|-1.15|0.081
73856482|NCT01559259|147258984|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.556|TWO_SIDED|95.0|-0.8|0.43|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.43|-0.80|0.556
73856483|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.53|||<|0.001|TWO_SIDED|95.0|2.01|3.05||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.05|2.01|<0.001
73856484|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.23|||<|0.001|TWO_SIDED|95.0|1.72|2.75||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.75|1.72|<0.001
73963906|NCT02539225|147463510|SUPERIORITY|||||||0.548|||||||Log Rank Stratified|||||||0.548
73963907|NCT02539225|147463511|SUPERIORITY||Odds Ratio (OR)|1.374||||0.402|TWO_SIDED|80.0|0.844|2.236|||Cochran-Mantel-Haenszel|||||2.236|0.844|0.402
73963908|NCT02539225|147463512|SUPERIORITY||Odds Ratio (OR)|1.527||||0.501|TWO_SIDED|80.0|0.68|3.433|||Cochran-Mantel-Haenszel|||||3.433|0.680|0.501
73963909|NCT00212134|147463516|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
73907078|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.71|TWO_SIDED|95.0|-0.28|0.41|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.41|-0.28|0.710
73907079|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.504|TWO_SIDED|95.0|-0.46|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.46|0.504
73907080|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.183|TWO_SIDED|95.0|-0.11|0.58|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.58|-0.11|0.183
73907081|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.919|TWO_SIDED|95.0|-0.36|0.33|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.36|0.919
73907082|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|95.0|-0.09|0.59|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.59|-0.09|0.152
73907083|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.572|TWO_SIDED|95.0|-0.44|0.24|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.24|-0.44|0.572
73963910|NCT00212134|147463517|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
73907084|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.337|TWO_SIDED|95.0|-0.51|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.51|0.337
73907085|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.17||0.299|TWO_SIDED|95.0|-0.16|0.52|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.52|-0.16|0.299
73907086|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.17|-0.5|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.50|-1.17|<0.001
73907087|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.22|-0.55|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.22|<0.001
73907088|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.01|-0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.01|<0.001
73907089|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.85|-0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.85|0.003
73907090|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.341|TWO_SIDED|95.0|-0.5|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.50|0.341
73907091|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.031|TWO_SIDED|95.0|-0.71|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.71|0.031
73907092|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.349|TWO_SIDED|95.0|-0.49|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.49|0.349
73907093|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.17||0.78|TWO_SIDED|95.0|-0.29|0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.29|0.780
73907094|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.31|-0.58|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.31|<0.001
73907095|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.29|<0.001
73907096|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-0.99|-0.26|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-0.99|<0.001
73907097|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.88|0.005
73907098|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.562|TWO_SIDED|95.0|-0.47|0.26|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.26|-0.47|0.562
73907099|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.028|TWO_SIDED|95.0|-0.77|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.77|0.028
73963911|NCT00212134|147463518|OTHER|||||||0.82|||||||Chi-squared|||||||0.82
73963912|NCT00212134|147463519|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
73963913|NCT00212134|147463520|SUPERIORITY|||||||0.008|||||||Fisher Exact|||||||0.008
73963914|NCT00212134|147463521|SUPERIORITY||Mean Difference (Final Values)|15.7|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||ITT analyses comparing parents of children randomized to receive an IOL to those left aphakic.||||<0.05
73963915|NCT00212134|147463523|SUPERIORITY||Mean Difference (Final Values)|7.295|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||ITT comparison of mean PSI scores||||>0.05
73963916|NCT06336629|147463589|SUPERIORITY||two-sided|100.0|||||TWO_SIDED|95.0||||||||||||
73856485|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.56|||<|0.001|TWO_SIDED|95.0|2.04|3.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.08|2.04|<0.001
73856486|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.57|2.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.60|1.57|<0.001
73856487|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.44||||0.016|TWO_SIDED|95.0|0.08|0.81||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.81|0.08|0.016
73856488|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.14||||0.428|TWO_SIDED|95.0|-0.21|0.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.50|-0.21|0.428
73856489|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.01|TWO_SIDED|95.0|0.11|0.84||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.84|0.11|0.010
73856490|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.38|||<|0.001|TWO_SIDED|95.0|6.59|10.18||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.18|6.59|<0.001
73856491|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.68|||<|0.001|TWO_SIDED|95.0|5.89|9.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.47|5.89|<0.001
73856492|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.7|||<|0.001|TWO_SIDED|95.0|6.91|10.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.50|6.91|<0.001
73856493|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.65|||<|0.001|TWO_SIDED|95.0|5.86|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.44|5.86|<0.001
73856494|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.25|TWO_SIDED|95.0|-0.52|1.99||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.99|-0.52|0.250
73856495|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.956|TWO_SIDED|95.0|-1.21|1.28||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.28|-1.21|0.956
73856496|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.06||||0.099|TWO_SIDED|95.0|-0.2|2.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.31|-0.20|0.099
73856497|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.22|||<|0.001|TWO_SIDED|95.0|7.78|12.66||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||12.66|7.78|<0.001
73856498|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|9.49|||<|0.001|TWO_SIDED|95.0|7.06|11.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||11.92|7.06|<0.001
73963917|NCT06336629|147463590|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
73963918|NCT06336629|147463591|SUPERIORITY|||||||0.007|||||||Wilcoxon rank-sum test|||||||0.007
73907100|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.19||0.084|TWO_SIDED|95.0|-0.68|0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.68|0.084
73907101|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.19||0.91|TWO_SIDED|95.0|-0.38|0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.38|0.910
73907102|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.69|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.40|<0.001
73907103|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.27|-0.56|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.27|<0.001
73907104|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.25|-0.55|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.25|<0.001
73907105|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.18||0.003|TWO_SIDED|95.0|-0.88|-0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.88|0.003
73907106|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.18||0.039|TWO_SIDED|95.0|-0.72|-0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.72|0.039
73907107|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.18||0.032|TWO_SIDED|95.0|-0.74|-0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.74|0.032
73907108|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.409|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.50|0.409
73907109|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.18||0.461|TWO_SIDED|95.0|-0.49|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.49|0.461
73907110|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.59|-0.84|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.84|-1.59|<0.001
73907111|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.4|-0.65|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.40|<0.001
73907112|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.17|-0.43|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.17|<0.001
73907113|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.97|-0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.22|-0.97|0.002
73907114|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.19||0.281|TWO_SIDED|95.0|-0.58|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.58|0.281
73907115|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.023|TWO_SIDED|95.0|-0.81|-0.06|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.81|0.023
73907116|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.031|TWO_SIDED|95.0|-0.79|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.79|0.031
73907117|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.19||0.331|TWO_SIDED|95.0|-0.56|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.56|0.331
73963919|NCT06336629|147463592|SUPERIORITY|||||||0.009|||||||Wilcoxon rank sum test|||||||0.009
73907118|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.47|-0.75|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.75|-1.47|<0.001
73907119|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.33|-0.6|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.60|-1.33|<0.001
73907120|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.03|-0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.31|-1.03|<0.001
73907121|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.98|-0.26|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-0.98|<0.001
73963920|NCT06336629|147463593|SUPERIORITY|||||||0.037||||||P-value from Baseline at Week 16|Wilcoxon signed rank|P-value from Baseline at Week 16||||||0.037
73963921|NCT06336629|147463595|SUPERIORITY|||||||1||||||P-value from Baseline at Week 16|Wilcoxon signed rank|||||||1
73963922|NCT06336629|147463596|SUPERIORITY|||||||1||||||P-value from Baseline at Week 16|Wilcoxon signed rank|||||||1
73963923|NCT04043455|147463605|SUPERIORITY||Least square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.407|=|0.65|TWO_SIDED|95.0|-0.99|0.62|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% confidence interval (CI) has been presented.||0.62|-0.99|=0.650
74025748|NCT01982630|147604264|OTHER||Difference of Least Squares Means|-3.97|||||TWO_SIDED|90.0|-6.8|-1.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||-1.14|-6.80|
74025749|NCT01982630|147604264|OTHER||Difference of Least Squares Means|-0.7|||||TWO_SIDED|90.0|-4.33|2.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||2.93|-4.33|
74025750|NCT01982630|147604264|OTHER||Difference of Least Squares Means|3.26|||||TWO_SIDED|90.0|-0.54|7.06|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.06|-0.54|
74025751|NCT01982630|147604265|OTHER||Difference of Least Squares Means|-1.58|||||TWO_SIDED|90.0|-5.31|2.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||2.15|-5.31|
74025752|NCT01982630|147604265|OTHER||Difference of Least Squares Means|2.52|||||TWO_SIDED|90.0|-2.32|7.35|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.35|-2.32|
74025753|NCT01982630|147604265|OTHER||Difference of Least Squares Means|4.1|||||TWO_SIDED|90.0|-0.96|9.16|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||9.16|-0.96|
74025754|NCT01982630|147604266|OTHER||Difference of Least Squares Means|-3.48|||||TWO_SIDED|90.0|-7.31|0.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||0.34|-7.31|
73856499|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.72|||<|0.001|TWO_SIDED|95.0|8.28|13.15||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||13.15|8.28|<0.001
73856500|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|9.63|||<|0.001|TWO_SIDED|95.0|7.19|12.06||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||12.06|7.19|<0.001
73856501|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.6||||0.492|TWO_SIDED|95.0|-1.11|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.30|-1.11|0.492
73856502|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.873|TWO_SIDED|95.0|-1.83|1.56||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.56|-1.83|0.873
73856503|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.09||||0.21|TWO_SIDED|95.0|-0.62|2.79||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.79|-0.62|0.210
73856504|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.65|||<|0.001|TWO_SIDED|95.0|8.1|15.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.20|8.10|<0.001
73856505|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.94|||<|0.001|TWO_SIDED|95.0|7.4|14.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.48|7.40|<0.001
73856506|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|12.65|||<|0.001|TWO_SIDED|95.0|9.1|16.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||16.20|9.10|<0.001
73907122|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.18||0.781|TWO_SIDED|95.0|-0.41|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.41|0.781
74025755|NCT01982630|147604266|OTHER||Difference of Least Squares Means|3.96|||||TWO_SIDED|90.0|-1.11|9.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||9.03|-1.11|
74025756|NCT01982630|147604266|OTHER||Difference of Least Squares Means|7.44|||||TWO_SIDED|90.0|2.16|12.73|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||12.73|2.16|
73963924|NCT04043455|147463605|SUPERIORITY||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.409|=|0.439|TWO_SIDED|95.0|-1.12|0.49|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||0.49|-1.12|=0.439
74025757|NCT01982630|147604267|OTHER||Difference of Least Squares Means|0.03|||||TWO_SIDED|90.0|-4.51|4.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||4.57|-4.51|
74025758|NCT01982630|147604267|OTHER||Difference of Least Squares Means|4.7|||||TWO_SIDED|90.0|-1.33|10.73|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||10.73|-1.33|
73963925|NCT04043455|147463605|SUPERIORITY||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.401|=|0.172|TWO_SIDED|95.0|-1.34|0.24|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||0.24|-1.34|=0.172
74025759|NCT01982630|147604267|OTHER||Difference of Least Squares Means|4.66|||||TWO_SIDED|90.0|-1.67|11.0|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||11.00|-1.67|
73856507|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.72|||<|0.001|TWO_SIDED|95.0|8.18|15.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.26|8.18|<0.001
73856508|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.957|TWO_SIDED|95.0|-2.55|2.42||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.42|-2.55|0.957
73856509|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.78||||0.534|TWO_SIDED|95.0|-3.25|1.69||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.69|-3.25|0.534
73856510|NCT01559259|147258985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.93||||0.462|TWO_SIDED|95.0|-1.55|3.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.41|-1.55|0.462
73856511|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.06|||<|0.001|TWO_SIDED|95.0|7.23|10.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.89|7.23|<0.001
73856512|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.14|||<|0.001|TWO_SIDED|95.0|6.33|9.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.95|6.33|<0.001
73856513|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.66|||<|0.001|TWO_SIDED|95.0|6.83|10.49||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.49|6.83|<0.001
73856514|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.61|||<|0.001|TWO_SIDED|95.0|5.78|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.44|5.78|<0.001
73856515|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.45||||0.024|TWO_SIDED|95.0|0.19|2.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.70|0.19|0.024
73856516|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.53||||0.392|TWO_SIDED|95.0|-0.69|1.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.76|-0.69|0.392
73963926|NCT04043455|147463612|SUPERIORITY||Odds Ratio (OR)|1.156||||0.659|TWO_SIDED|95.0|-0.019|2.331|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 10 mg and placebo using Odds ratio and 95% CI has been presented.||2.331|-0.019|0.659
73963927|NCT04043455|147463612|SUPERIORITY||Odds Ratio (OR)|1.248||||0.557|TWO_SIDED|95.0|-0.04|2.535|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 25 mg and placebo using Odds ratio and 95% CI has been presented.||2.535|-0.040|0.557
73907123|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.057|TWO_SIDED|95.0|-0.71|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.71|0.057
73907124|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.016|TWO_SIDED|95.0|-0.8|-0.08|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.80|0.016
73907125|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.45|TWO_SIDED|95.0|-0.5|0.22|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.50|0.450
73907126|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.47|-0.69|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.47|<0.001
73907127|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.2|-0.42|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.20|<0.001
73907128|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.12|-0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.12|<0.001
73907129|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.04|-0.26|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-1.04|0.001
73907130|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.2||0.699|TWO_SIDED|95.0|-0.47|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.47|0.699
73907131|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2||0.408|TWO_SIDED|95.0|-0.55|0.22|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.55|0.408
73907132|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.077|TWO_SIDED|95.0|-0.74|0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.74|0.077
73907133|NCT00809354|147344741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.2||0.182|TWO_SIDED|95.0|-0.65|0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.65|0.182
73907134|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.16||0.798|TWO_SIDED|95.0|-0.36|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.36|0.798
73907135|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.779|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.37|0.779
73907136|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.057|TWO_SIDED|95.0|-0.64|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.64|0.057
73907137|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.16||0.927|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.31|0.927
73907138|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.98|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.980
73907139|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.16||0.098|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.60|0.098
73907140|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.26|0.709
73907141|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.045|TWO_SIDED|95.0|0.01|0.65|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.65|0.01|0.045
73963928|NCT04043455|147463612|SUPERIORITY||Odds Ratio (OR)|1.245||||0.541|TWO_SIDED|95.0|0.027|2.462|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 50 mg and placebo using Odds ratio and 95% CI has been presented.||2.462|0.027|0.541
73963929|NCT04043455|147463613|SUPERIORITY||Odds Ratio (OR)|1.234||||0.529|TWO_SIDED|95.0|-0.001|2.468|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 10 mg and placebo using Odd's ratio and 95% CI has been presented.||2.468|-0.001|0.529
73907142|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.919|TWO_SIDED|95.0|-0.36|0.33|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.36|0.919
73907143|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.183|TWO_SIDED|95.0|-0.11|0.58|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.58|-0.11|0.183
73963930|NCT04043455|147463613|SUPERIORITY||Odds Ratio (OR)|1.123||||0.73|TWO_SIDED|95.0|0.015|2.232|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 25 mg and placebo using Odd's ratio and 95% CI has been presented.||2.232|0.015|0.730
73963931|NCT04043455|147463613|SUPERIORITY||Odds Ratio (OR)|1.226||||0.548|TWO_SIDED|95.0|0.025|2.428|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 50 mg and placebo using Odd's ratio and 95% CI has been presented.||2.428|0.025|0.548
73963932|NCT04043455|147463614|SUPERIORITY||Least square mean difference|-2.42|STANDARD_ERROR_OF_MEAN|6.189||0.696|TWO_SIDED|95.0|-14.61|9.76|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% CI has been presented.||9.76|-14.61|0.696
73963933|NCT04043455|147463614|SUPERIORITY||Least square mean difference|-3.25|STANDARD_ERROR_OF_MEAN|6.222||0.602|TWO_SIDED|95.0|-15.51|9.0|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||9.00|-15.51|0.602
73963934|NCT04043455|147463614|SUPERIORITY||Least square mean difference|-3.96|STANDARD_ERROR_OF_MEAN|6.088||0.516|TWO_SIDED|95.0|-15.95|8.03|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||8.03|-15.95|0.516
73907144|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.504|TWO_SIDED|95.0|-0.46|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.46|0.504
73963935|NCT04043455|147463615|SUPERIORITY||Least square mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.305||0.804|TWO_SIDED|95.0|-0.53|0.68|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% CI has been presented.||0.68|-0.53|0.804
73963936|NCT04043455|147463615|SUPERIORITY||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.308||0.618|TWO_SIDED|95.0|-0.76|0.45|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||0.45|-0.76|0.618
73963937|NCT04043455|147463615|SUPERIORITY||Least square mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.301||0.687|TWO_SIDED|95.0|-0.47|0.71|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||0.71|-0.47|0.687
73963938|NCT02980276|147463728|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-6.9||||0.13|TWO_SIDED|95.0|-15.1|1.4||The primary analysis, as per sample size calculation, was a two-sample comparison of reduction in the proportion of women needing insulin between treatment and control arms using an exact test for a binomial response.|Risk difference||Units are %|The primary analysis, as per sample size calculation, was a two-sample comparison of reduction in the proportion of women needing insulin between treatment and control arms using an exact test for a binomial response.||1.4|-15.1|0.13
73963939|NCT02980276|147463729|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-12.7||||0.004|TWO_SIDED|95.0|-21.2|-4.3|||Risk difference||Units are %|||-4.3|-21.2|0.004
73963940|NCT02980276|147463730|SUPERIORITY|||||||0.001|||||||Log Rank|Median survival times could not be calculated; time to insulin initiation would be censored at delivery in \>50% of participants in treatment group.||||||0.001
73963941|NCT02980276|147463731|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio, log|0.61||||0.005|TWO_SIDED|95.0|0.43|0.86|||Regression, Logistic|Unadjusted|Unadjusted|||0.86|0.43|0.005
73963942|NCT02980276|147463731|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.56||||0.003|TWO_SIDED|95.0|0.38|0.82|||Regression, Logistic|Adjusted|Adjusted|||0.82|0.38|0.003
73963943|NCT02980276|147463732|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.78||||0.178|TWO_SIDED|95.0|0.55|1.12|||Regression, Logistic||Unadjusted|||1.12|0.55|0.178
73963944|NCT02980276|147463732|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.72||||0.105|TWO_SIDED|95.0|0.48|1.07||Two-sided test comparing observed odds ratio to 1.|Regression, Logistic||Adjusted|||1.07|0.48|0.105
73963945|NCT02980276|147463733|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|-3.7||||0.17|TWO_SIDED|95.0|-9.3|1.7|||t-test, 2 sided|||||1.7|-9.3|0.17
73907145|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.71|TWO_SIDED|95.0|-0.28|0.41|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.41|-0.28|0.710
73907146|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|95.0|-0.09|0.59|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.59|-0.09|0.152
73907147|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.572|TWO_SIDED|95.0|-0.44|0.24|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.24|-0.44|0.572
73963946|NCT02980276|147463734|EQUIVALENCE|Two-sided test comparing observed mean difference ratio to zero.|Mean Difference (Final Values)|-1.2||||0.003|TWO_SIDED|95.0|-1.99|-0.42|||t-test, 2 sided|||||-0.42|-1.99|0.003
73963947|NCT02980276|147463735|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.21||||0.99|TWO_SIDED|95.0|0.65|1.55|||Regression, Logistic|||||1.55|0.65|0.99
73963948|NCT02980276|147463736|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.96||||0.911|TWO_SIDED|95.0|0.46|2.0|||Regression, Logistic|||||2|0.46|0.911
73963949|NCT02980276|147463737|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.82||||0.519|TWO_SIDED|95.0|0.44|1.51|||Regression, Logistic|||||1.51|0.44|0.519
73963950|NCT02980276|147463738|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.66|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||||0.2|-0.3|0.66
73963951|NCT02980276|147463739|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.21||||0.367|TWO_SIDED|95.0|0.8|1.85|||Regression, Logistic|Unadjusted|Unadjusted|||1.85|0.8|0.367
73963952|NCT02980276|147463739|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.22||||0.359|TWO_SIDED|95.0|0.8|1.87|||Regression, Logistic|Adjusted|Adjusted|||1.87|0.8|0.359
73963953|NCT02980276|147463740|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-6.5||||1|TWO_SIDED|95.0|-13.9|12.9|||Risk difference||Units are %|||12.9|-13.9|1.0
73963954|NCT02980276|147463741|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.603|TWO_SIDED|95.0|0.56|1.39|||Regression, Logistic|Unadjusted|Unadjusted|||1.39|0.56|0.603
73963955|NCT02980276|147463741|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.621|TWO_SIDED|95.0|0.57|1.4|||Regression, Logistic|Adjusted|Adjusted|||1.4|0.57|0.621
73963956|NCT02980276|147463742|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.739|TWO_SIDED|95.0|0.45|1.76|||Regression, Logistic|Unadjusted|Unadjusted|||1.76|0.45|0.739
73963957|NCT02980276|147463742|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.92||||0.812|TWO_SIDED|95.0|0.46|1.84|||Regression, Logistic|Adjusted|Adjusted|||1.84|0.46|0.812
73963958|NCT02980276|147463743|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.84||||0.282|TWO_SIDED|95.0|0.63|6.04|||Regression, Logistic|Unadjusted|Unadjusted|Unadjusted||6.04|0.63|0.282
73963959|NCT02980276|147463743|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|2.14||||0.196|TWO_SIDED|95.0|0.7|7.38|||Regression, Logistic||Adjusted|||7.38|0.7|0.196
73963960|NCT02980276|147463744|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.53||||0.058|TWO_SIDED|95.0|0.27|1.01|||Regression, Logistic|Unadjusted||||1.01|0.27|0.058
73963961|NCT02980276|147463744|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.53||||0.061|TWO_SIDED|95.0|0.27|1.02|||Regression, Logistic|Adjusted||||1.02|0.27|0.061
73963962|NCT02980276|147463745|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-4.5||||0.24|TWO_SIDED|95.0|-11.6|2.5|||Risk difference||Units are %|||2.5|-11.6|0.24
73907148|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.337|TWO_SIDED|95.0|-0.51|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.51|0.337
73907149|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.17||0.299|TWO_SIDED|95.0|-0.16|0.52|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.52|-0.16|0.299
73907150|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.17||0.005|TWO_SIDED|95.0|-0.82|-0.14|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.82|0.005
73963963|NCT02980276|147463745|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.81||||0.24|TWO_SIDED|95.0|0.59|1.12|||Regression, Logistic||Units are %|||1.12|0.59|0.24
73907151|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.05|-0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.38|-1.05|<0.001
73907152|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.25|-0.57|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.25|<0.001
73907153|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.23|-0.56|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.23|<0.001
73963964|NCT02980276|147463746|EQUIVALENCE|Regression model that adjusts for the infant's sex and maternal height and weight at randomization.|Median Difference (Final Values)|-113.0||||0.005|TWO_SIDED|95.0|-201.0|-24.0|||Regression, Linear|P value was derived from a statistical model that adjusts for the infant's sex and maternal height and weight at randomization.||||-24|-201|0.005
74085116|NCT00407745|147723829|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.038||0.3312|TWO_SIDED|95.0|-0.11|0.04||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Burning Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.04|-0.11|0.3312
73907154|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.177|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.177
73963965|NCT02980276|147463747|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.82|TWO_SIDED|95.0|-0.3|0.3|||t-test, 2 sided|||||0.3|-0.3|0.82
73963966|NCT02980276|147463748|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|-0.7||||0.02|TWO_SIDED|95.0|-1.3|-0.2|||t-test, 2 sided|||||-0.2|-1.3|0.02
74085117|NCT00407745|147723830|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.044|TWO_SIDED|95.0|-0.13|0.0||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Pressing Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.00|-0.13|0.0440
73907155|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.17||0.014|TWO_SIDED|95.0|-0.76|-0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.76|0.014
73963967|NCT02980276|147463749|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.1||||0.72|TWO_SIDED|95.0|-0.5|0.7|||t-test, 2 sided|||||0.7|-0.5|0.72
73963968|NCT02980276|147463750|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.68|TWO_SIDED|95.0|-0.1|0.1|||t-test, 2 sided|||||0.1|-0.1|0.68
73963969|NCT02980276|147463751|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-7.2||||0.02|TWO_SIDED|95.0|-12.6|-1.8|||Regression, Logistic|P value derived from a statistical model that adjusts for the infant's sex, gestational age at birth, and maternal height and weight at randomization.|P value derived from a statistical model that adjusts for the infant's sex, gestational age at birth, and maternal height and weight at randomization.|||-1.8|-12.6|0.02
73963970|NCT02980276|147463752|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-8.4||||0.003|TWO_SIDED|95.0|-13.7|-3.2|||Risk difference|P value derived from a statistical model that adjusts for the infant's sex and maternal height and weight at randomization|Units are %|||-3.2|-13.7|0.003
74085118|NCT00407745|147723831|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.033||0.137|TWO_SIDED|95.0|-0.12|0.02||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paroxysmal Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.02|-0.12|0.1370
73856517|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.05||||0.101|TWO_SIDED|95.0|-0.21|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.30|-0.21|0.101
73856518|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|30.23|||<|0.001|TWO_SIDED|95.0|23.97|36.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||36.48|23.97|<0.001
73856519|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.93|||<|0.001|TWO_SIDED|95.0|21.74|34.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||34.11|21.74|<0.001
73856520|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|29.86|||<|0.001|TWO_SIDED|95.0|23.6|36.12||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||36.12|23.60|<0.001
73856521|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.59|||<|0.001|TWO_SIDED|95.0|21.33|33.86||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||33.86|21.33|<0.001
73856522|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.63||||0.228|TWO_SIDED|95.0|-1.65|6.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.92|-1.65|0.228
73856523|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.875|TWO_SIDED|95.0|-3.84|4.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.51|-3.84|0.875
73856524|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.27||||0.299|TWO_SIDED|95.0|-2.02|6.55||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.55|-2.02|0.299
73856525|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|36.98|||<|0.001|TWO_SIDED|95.0|28.48|45.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||45.47|28.48|<0.001
73856526|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|35.1|||<|0.001|TWO_SIDED|95.0|26.7|43.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||43.50|26.70|<0.001
73856527|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|37.09|||<|0.001|TWO_SIDED|95.0|28.6|45.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||45.59|28.60|<0.001
73856528|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|35.17|||<|0.001|TWO_SIDED|95.0|26.67|43.68||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||43.68|26.67|<0.001
73856529|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.8||||0.543|TWO_SIDED|95.0|-4.02|7.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.63|-4.02|0.543
73856530|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.979|TWO_SIDED|95.0|-5.75|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.60|-5.75|0.979
73856531|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.92||||0.517|TWO_SIDED|95.0|-3.9|7.74||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.74|-3.90|0.517
73856532|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|42.96|||<|0.001|TWO_SIDED|95.0|30.51|55.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||55.41|30.51|<0.001
73856533|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|42.2|||<|0.001|TWO_SIDED|95.0|29.9|54.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||54.51|29.90|<0.001
73856534|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|45.12|||<|0.001|TWO_SIDED|95.0|32.67|57.57||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||57.57|32.67|<0.001
73856535|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|44.25|||<|0.001|TWO_SIDED|95.0|31.79|56.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||56.71|31.79|<0.001
73856536|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.29||||0.767|TWO_SIDED|95.0|-9.82|7.25||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.25|-9.82|0.767
73856537|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.04||||0.629|TWO_SIDED|95.0|-10.36|6.27||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.27|-10.36|0.629
73856538|NCT01559259|147258986|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.87||||0.841|TWO_SIDED|95.0|-7.66|9.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.39|-7.66|0.841
73856539|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.97|||<|0.001|TWO_SIDED|95.0|3.22|4.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.73|3.22|<0.001
73963971|NCT02980276|147463753|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.7||||0.012|TWO_SIDED|95.0|-1.0|6.3|||Risk difference|Units are %. P value derived from model adjusting for the gestational age at birth, sex and maternal height and weight at randomization.|Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|||6.3|-1|.012
73856540|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.64|||<|0.001|TWO_SIDED|95.0|2.88|4.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.39|2.88|<0.001
73856541|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.07|||<|0.001|TWO_SIDED|95.0|3.32|4.83||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.83|3.32|<0.001
73907156|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.286|TWO_SIDED|95.0|-0.52|0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.52|0.286
73907157|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.952|TWO_SIDED|95.0|-0.33|0.35|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.33|0.952
73907158|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.95|-0.21|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.21|-0.95|0.002
73907159|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|-0.94|-0.2|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.20|-0.94|0.003
73907160|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.26|-0.52|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.52|-1.26|<0.001
73907161|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.29|-0.55|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.29|<0.001
73907162|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.972|TWO_SIDED|95.0|-0.36|0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.36|0.972
73907163|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.096|TWO_SIDED|95.0|-0.69|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.69|0.096
73907164|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.19||0.069|TWO_SIDED|95.0|-0.72|0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.72|0.069
73907165|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.19||0.902|TWO_SIDED|95.0|-0.39|0.35|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.39|0.902
73907166|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.93|-0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.22|-0.93|0.002
73907167|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.33|-0.61|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.61|-1.33|<0.001
73907168|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.38|-0.66|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.66|-1.38|<0.001
73907169|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.55|-0.84|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.84|-1.55|<0.001
73907170|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.028|TWO_SIDED|95.0|-0.75|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.75|0.028
73907171|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.013|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.81|0.013
73907172|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.18||0.217|TWO_SIDED|95.0|-0.58|0.13|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.58|0.217
73907173|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.18||0.351|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.53|0.351
73907174|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.28|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.28|-1.05|<0.001
73907175|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.22|-0.45|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.45|-1.22|<0.001
73907176|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.38|-0.62|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.62|-1.38|<0.001
73907177|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.57|-0.8|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.80|-1.57|<0.001
73907178|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.389|TWO_SIDED|95.0|-0.55|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.55|0.389
73907179|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.087|TWO_SIDED|95.0|-0.72|0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.72|0.087
74085119|NCT00407745|147723832|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.028||0.8911|TWO_SIDED|95.0|-0.06|0.05||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Evoked pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.05|-0.06|0.8911
73856542|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.39|||<|0.001|TWO_SIDED|95.0|2.64|4.14||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.14|2.64|<0.001
74025760|NCT01982630|147604268|OTHER||Difference of Least Squares Means|3.34|||||TWO_SIDED|90.0|-0.7|7.39|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.39|-0.70|
74025761|NCT01982630|147604268|OTHER||Difference of Least Squares Means|8.88|||||TWO_SIDED|90.0|3.53|14.23|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||14.23|3.53|
74025762|NCT01982630|147604268|OTHER||Difference of Least Squares Means|5.54|||||TWO_SIDED|90.0|-0.08|11.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||11.15|-0.08|
74025763|NCT01982630|147604269|OTHER||Difference of Least Squares Means|-3.55|||||TWO_SIDED|90.0|-6.98|-0.12|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||-0.12|-6.98|
74025764|NCT01982630|147604269|OTHER||Difference of Least Squares Means|1.05|||||TWO_SIDED|90.0|-3.38|5.49|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||5.49|-3.38|
74025765|NCT01982630|147604269|OTHER||Difference of Least Squares Means|4.61|||||TWO_SIDED|90.0|-0.02|9.23|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||9.23|-0.02|
74025766|NCT01982630|147604270|OTHER||Difference of Least Squares Means|-1.16|||||TWO_SIDED|90.0|-4.59|2.28|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||2.28|-4.59|
73856543|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.58||||0.031|TWO_SIDED|95.0|0.05|1.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.11|0.05|0.031
73907180|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.072|TWO_SIDED|95.0|-0.74|0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.74|0.072
73907181|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.34|TWO_SIDED|95.0|-0.57|0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.57|0.340
73907182|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
73907183|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.11|-0.39|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.39|-1.11|<0.001
74025767|NCT01982630|147604270|OTHER||Difference of Least Squares Means|8.65|||||TWO_SIDED|90.0|3.99|13.31|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||13.31|3.99|
73856544|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.24||||0.36|TWO_SIDED|95.0|-0.28|0.77||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.77|-0.28|0.360
73907184|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.42|-0.69|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.42|<0.001
74025768|NCT01982630|147604270|OTHER||Difference of Least Squares Means|9.8|||||TWO_SIDED|90.0|4.96|14.65|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||14.65|4.96|
74025769|NCT01982630|147604271|OTHER||Difference of Least Squares Means|-4.04|||||TWO_SIDED|90.0|-7.52|-0.56|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||-0.56|-7.52|
74025770|NCT01982630|147604271|OTHER||Difference of Least Squares Means|10.23|||||TWO_SIDED|90.0|5.57|14.89|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||14.89|5.57|
74025771|NCT01982630|147604271|OTHER||Difference of Least Squares Means|14.27|||||TWO_SIDED|90.0|9.38|19.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||19.15|9.38|
73907185|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.59|-0.87|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.87|-1.59|<0.001
73907186|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.762|TWO_SIDED|95.0|-0.42|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.42|0.762
73963972|NCT02980276|147463754|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|3.0||||0.13|TWO_SIDED|95.0|-0.4|6.5||Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|Regression, Logistic||Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|||6.5|-0.4|0.13
73963973|NCT02980276|147463755|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|3.0||||0.38|TWO_SIDED|95.0|-2.9|9.0|||Risk difference||Units are %.|||9|-2.9|0.38
73963974|NCT02980276|147463756|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.8||||0.33|TWO_SIDED|95.0|-2.0|7.3|||Risk difference||Units are %|||7.3|-2.0|0.33
73963975|NCT02980276|147463757|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.3||||0.42|TWO_SIDED|95.0|-2.4|6.9|||Risk difference||Units are %|||6.9|-2.4|0.42
73963976|NCT02980276|147463758|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.4|||>|0.99|TWO_SIDED|95.0|-0.4|1.1|||Risk difference||Units are %.|||1.1|-0.4|>0.99
74085120|NCT00407745|147723833|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.034||0.3731|TWO_SIDED|95.0|-0.1|0.04||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paresthesia/Dysesthesia as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.04|-0.10|0.3731
73907187|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.19||0.056|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.72|0.056
73907188|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.01|TWO_SIDED|95.0|-0.84|-0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.84|0.010
73907189|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.19||0.335|TWO_SIDED|95.0|-0.54|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.54|0.335
73907190|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.18|-0.38|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.38|-1.18|<0.001
73907191|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.24|-0.44|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.44|-1.24|<0.001
73907192|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.25|-0.46|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.46|-1.25|<0.001
73907193|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.52|-0.73|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.73|-1.52|<0.001
73907194|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.782|TWO_SIDED|95.0|-0.46|0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.46|0.782
73963977|NCT02980276|147463759|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|1.1||||0.62|TWO_SIDED|95.0|-1.9|4.2|||Risk difference||Units are %|||4.2|-1.9|0.62
73963978|NCT02980276|147463760|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.0|||>|0.99|TWO_SIDED|95.0|-1.0|1.0|||Risk difference||Units are %|||1|-1|>0.99
73907195|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.719|TWO_SIDED|95.0|-0.47|0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.47|0.719
73907196|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.2||0.158|TWO_SIDED|95.0|-0.69|0.11|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.69|0.158
73907197|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.183|TWO_SIDED|95.0|-0.67|0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.67|0.183
73907198|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.004|TWO_SIDED|95.0|-0.9|-0.18|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.90|0.004
73963979|NCT02980276|147463761|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.7||||0.9|TWO_SIDED|95.0|-5.1|6.6|||Risk difference||Units are %|||6.6|-5.1|0.9
73963980|NCT05286385|147463781|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|4.59|||TWO_SIDED|95.0|-6.29|0.29||||||||0.29|-6.29|
73963981|NCT05286385|147463782|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|8.03|||TWO_SIDED|95.0|-8.04|3.44||||||||3.44|-8.04|
73963982|NCT05286385|147463783|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|4.55|||TWO_SIDED|95.0|-2.95|3.55||||||||3.55|-2.95|
73907199|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.05|-0.33|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.05|<0.001
73907200|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.2|0.48|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.48|-1.20|<0.001
73907201|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.48|-0.76|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.76|-1.48|<0.001
73907202|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.408|TWO_SIDED|95.0|-0.51|0.21|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.51|0.408
73907203|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.097|TWO_SIDED|95.0|-0.67|0.06|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.67|0.097
73907204|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.018|TWO_SIDED|95.0|-0.79|-0.07|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.79|0.018
73907205|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.132|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.64|0.132
73907206|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.21||0.001|TWO_SIDED|95.0|-1.08|-0.26|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.26|-1.08|0.001
73907207|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.21||0.002|TWO_SIDED|95.0|-1.07|-0.25|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.25|-1.07|0.002
73907208|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.19|-0.37|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.37|-1.19|<0.001
73907209|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.37|-0.55|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.55|-1.37|<0.001
73907210|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.21||0.959|TWO_SIDED|95.0|-0.4|0.42|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.42|-0.40|0.959
73907211|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.618|TWO_SIDED|95.0|-0.51|0.31|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.31|-0.51|0.618
73907212|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.149|TWO_SIDED|95.0|-0.71|0.11|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.11|-0.71|0.149
73907213|NCT00809354|147344742|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.21||0.37|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.22|-0.60|0.370
73907214|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.887|TWO_SIDED|95.0|-0.33|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.33|0.887
73963983|NCT04524390|147463936|SUPERIORITY||Least-Square mean|-0.39|STANDARD_ERROR_OF_MEAN|1.182||0.7419|TWO_SIDED|95.0|-2.76|1.97|||MMRM|||||1.97|-2.76|0.7419
73907215|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.046|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.62|0.046
73907216|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.16||0.771|TWO_SIDED|95.0|-0.26|0.35|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.26|0.771
73907217|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.16||0.032|TWO_SIDED|95.0|0.03|0.64|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.64|0.03|0.032
73907218|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.13|0.54|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.54|-0.13|0.223
73963984|NCT04524390|147463937|SUPERIORITY||Least-Square mean|-45.9|STANDARD_ERROR_OF_MEAN|35.398||0.2002|TWO_SIDED|95.0|-116.86|25.05|||MMRM|||||25.05|-116.86|0.2002
73963985|NCT04524390|147463938|SUPERIORITY|||||||0.8412|||||||Barnard's exact test|||||||0.8412
73963986|NCT04524390|147463939|SUPERIORITY||||||>|0.9999|||||||Barnard's exact test|||||||> 0.9999
73907219|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.718|TWO_SIDED|95.0|-0.39|0.27|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.39|0.718
73907220|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.495|TWO_SIDED|95.0|-0.45|0.22|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.45|0.495
73907221|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.17||0.371|TWO_SIDED|95.0|-0.18|0.49|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.49|-0.18|0.371
73963987|NCT04524390|147463940|SUPERIORITY|||||||0.6658|||||||Barnard's exact test|||||||0.6658
73963988|NCT04524390|147463941|SUPERIORITY|||||||0.6236|||||||Barnard's exact test|||||||0.6236
73963989|NCT04524390|147463942|SUPERIORITY|||||||0.6658|||||||Barnard's exact test|||||||0.6658
73963990|NCT04524390|147463943|SUPERIORITY|||||||0.6659|||||||Barnard's exact test|||||||0.6659
73963991|NCT05930782|147463948|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of Cmax falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|73.9|||||TWO_SIDED|90.0|48.32|113.02||||||||113.02|48.32|
73963992|NCT05930782|147463949|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratio (GMR)|75.41|||||TWO_SIDED|90.0|56.46|100.71||||||||100.71|56.46|
73963993|NCT05930782|147463950|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|86.45|||||TWO_SIDED|90.0|68.16|109.63||||||||109.63|68.16|
73963994|NCT05930782|147463951|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|77.67|||||TWO_SIDED|90.0|59.49|101.39||||||||101.39|59.49|
73963995|NCT05930782|147463952|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|55.24|||||TWO_SIDED|90.0|6.03|113.02|||||For AUC0-inf, the GMR and 90% CI values were unreliable as there was only 1 calculable value for the Test (Group 2) and 2 values for the Reference (Group 1) products.|||113.02|6.03|
73963996|NCT00174382|147463953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.33||0.182||95.0|-0.21|1.09||Baseline value, center, and week as fixed effects; subject was included as a random effect.|Mixed Models Analysis|||Week 12 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||1.09|-0.21|0.182
73963997|NCT00174382|147463953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|STANDARD_ERROR_OF_MEAN|0.36||0.067||95.0|-0.05|1.36|||Mixed Models Analysis|||Week 24 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||1.36|-0.05|0.067
73963998|NCT00174382|147463953|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Mixed Models Analysis|||Week 24 LOCF Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||||0.085
73963999|NCT00174382|147463954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.16||0.218||95.0|-1.2|5.19|||Mixed Models Analysis|||||5.19|-1.20|0.218
73964000|NCT00174382|147463954|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|2.12||0.385||95.0|-6.03|2.34|||Mixed Models Analysis|||||2.34|-6.03|0.385
73964001|NCT00174382|147463954|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||Mixed Models Analysis|||||||0.228
73964002|NCT00174382|147463955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.84|STANDARD_ERROR_OF_MEAN|2.19||0.404||95.0|-2.51|6.18|||Mixed Models Analysis|||||6.18|-2.51|0.404
73964003|NCT00174382|147463955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|2.56||0.826||95.0|-4.51|5.64|||Mixed Models Analysis|||||5.64|-4.51|0.826
73964004|NCT00174382|147463955|SUPERIORITY_OR_OTHER|||||||0.494||95.0|||||Mixed Models Analysis|||||||0.494
73964005|NCT00174382|147463956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.78|STANDARD_ERROR_OF_MEAN|1.61||0.272||95.0|-1.42|4.99|||Mixed Models Analysis|||||4.99|-1.42|0.272
73964006|NCT00174382|147463956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|2.0||0.894||95.0|-4.21|3.68|||Mixed Models Analysis|||||3.68|-4.21|0.894
73964007|NCT00174382|147463956|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Mixed Models Analysis|||||||0.906
73964008|NCT00174382|147463957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.35||0.719||95.0|-0.56|0.82|||Mixed Models Analysis|||||0.82|-0.56|0.719
73964009|NCT00174382|147463957|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.36||0.006||95.0|0.29|1.71|||Mixed Models Analysis|||||1.71|0.29|0.006
73964010|NCT00174382|147463957|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Mixed Models Analysis|||||||0.007
73964011|NCT00174382|147463958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.35||0.368||95.0|-0.38|1.01|||Mixed Models Analysis|||||1.01|-0.38|0.368
74025772|NCT01982630|147604272|OTHER||Difference of Least Squares Means|-2.12|||||TWO_SIDED|90.0|-5.7|1.47|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||1.47|-5.70|
73856545|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.68||||0.011|TWO_SIDED|95.0|0.15|1.21||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.21|0.15|0.011
74025773|NCT01982630|147604272|OTHER||Difference of Least Squares Means|13.34|||||TWO_SIDED|90.0|8.64|18.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||18.03|8.64|
73856546|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|13.14|||<|0.001|TWO_SIDED|95.0|10.54|15.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.73|10.54|<0.001
73856547|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.94|||<|0.001|TWO_SIDED|95.0|9.35|14.52||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.52|9.35|<0.001
73856548|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|13.54|||<|0.001|TWO_SIDED|95.0|10.95|16.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||16.13|10.95|<0.001
73856549|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|12.04|||<|0.001|TWO_SIDED|95.0|9.45|14.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.63|9.45|<0.001
73856550|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.1||||0.235|TWO_SIDED|95.0|-0.72|2.91||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.91|-0.72|0.235
73856551|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.91|TWO_SIDED|95.0|-1.91|1.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.70|-1.91|0.910
73856552|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5||||0.105|TWO_SIDED|95.0|-0.32|3.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.31|-0.32|0.105
73856553|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|16.05|||<|0.001|TWO_SIDED|95.0|12.49|19.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||19.61|12.49|<0.001
73856554|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|14.88|||<|0.001|TWO_SIDED|95.0|11.33|18.43||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||18.43|11.33|<0.001
73856555|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|16.76|||<|0.001|TWO_SIDED|95.0|13.2|20.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||20.32|13.20|<0.001
73856556|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|15.23|||<|0.001|TWO_SIDED|95.0|11.68|18.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||18.78|11.68|<0.001
74025774|NCT01982630|147604272|OTHER||Difference of Least Squares Means|15.45|||||TWO_SIDED|90.0|10.53|20.38|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||20.38|10.53|
74025775|NCT01982630|147604273|OTHER||Difference of Least Squares Means|2.11|||||TWO_SIDED|90.0|-1.47|5.7|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||5.70|-1.47|
73964012|NCT00174382|147463958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|0.33||0.03||95.0|0.07|1.37|||Mixed Models Analysis|||||1.37|0.07|0.030
73964013|NCT00174382|147463958|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Mixed Models Analysis|||||||0.060
73856557|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.514|TWO_SIDED|95.0|-1.66|3.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.32|-1.66|0.514
73856558|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.35||||0.783|TWO_SIDED|95.0|-2.82|2.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.13|-2.82|0.783
74025776|NCT01982630|147604273|OTHER||Difference of Least Squares Means|10.43|||||TWO_SIDED|90.0|5.73|15.13|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||15.13|5.73|
74025777|NCT01982630|147604273|OTHER||Difference of Least Squares Means|8.32|||||TWO_SIDED|90.0|3.4|13.24|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||13.24|3.40|
73856559|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53||||0.227|TWO_SIDED|95.0|-0.96|4.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.02|-0.96|0.227
73856560|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|18.28|||<|0.001|TWO_SIDED|95.0|12.95|23.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||23.61|12.95|<0.001
73856561|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|17.3|||<|0.001|TWO_SIDED|95.0|11.99|22.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||22.61|11.99|<0.001
73856562|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|20.45|||<|0.001|TWO_SIDED|95.0|15.13|25.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||25.78|15.13|<0.001
73856563|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|18.92|||<|0.001|TWO_SIDED|95.0|13.61|24.24||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||24.24|13.61|<0.001
73856564|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.64||||0.736|TWO_SIDED|95.0|-4.37|3.09||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.09|-4.37|0.736
74025778|NCT01982630|147604289|OTHER||Difference of Least Squares Means|29.56|||||TWO_SIDED|90.0|4.34|54.77|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||54.77|4.34|
73856565|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.62||||0.39|TWO_SIDED|95.0|-5.32|2.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.08|-5.32|0.390
73856566|NCT01559259|147258987|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53||||0.42|TWO_SIDED|95.0|-2.19|5.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.26|-2.19|0.420
73964014|NCT00174382|147463959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.33||0.516||95.0|-0.44|0.86|||Mixed Models Analysis|||||0.86|-0.44|0.516
73964015|NCT00174382|147463959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.32||0.297||95.0|-0.97|0.3|||Mixed Models Analysis|||||0.30|-0.97|0.297
73964016|NCT00174382|147463959|SUPERIORITY_OR_OTHER|||||||0.133||95.0|||||Mixed Models Analysis|||||||0.133
73964017|NCT00174382|147463960|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.79|STANDARD_ERROR_OF_MEAN|0.33||0.02||95.0|0.13|1.45|||Mixed Models Analysis|||||1.45|0.13|0.020
73964018|NCT00174382|147463960|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|0.36||0.018||95.0|0.16|1.59|||Mixed Models Analysis|||||1.59|0.16|0.018
73964019|NCT00174382|147463960|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Mixed Models Analysis|||||||0.004
73964020|NCT00174382|147463961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.42||0.01||95.0|-1.93|-0.27|||Mixed Models Analysis|||||-0.27|-1.93|0.010
73907222|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.647|TWO_SIDED|95.0|-0.4|0.25|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.40|0.647
73907223|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.073|TWO_SIDED|95.0|-0.62|0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.62|0.073
73907224|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.161|TWO_SIDED|95.0|-0.55|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.55|0.161
73907225|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.16||0.961|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.961
73907226|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.18||0.697|TWO_SIDED|95.0|-0.42|0.28|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.42|0.697
73907227|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.18||0.139|TWO_SIDED|95.0|-0.62|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.62|0.139
73907228|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.12|TWO_SIDED|95.0|-0.64|0.07|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.64|0.120
73907229|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.637|TWO_SIDED|95.0|-0.44|0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.44|0.637
73907230|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.028|TWO_SIDED|95.0|-0.72|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.72|0.028
73907231|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.17||0.024|TWO_SIDED|95.0|-0.74|-0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.74|0.024
73907232|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.339|TWO_SIDED|95.0|-0.51|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.51|0.339
73907233|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.381|TWO_SIDED|95.0|-0.5|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.50|0.381
73907234|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.19||0.438|TWO_SIDED|95.0|-0.51|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.51|0.438
73907235|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.111|TWO_SIDED|95.0|-0.66|0.07|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.66|0.111
73907236|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.059|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.72|0.059
73907237|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.282|TWO_SIDED|95.0|-0.57|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.57|0.282
73907238|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.18||0.927|TWO_SIDED|95.0|-0.37|0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.37|0.927
73907239|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.094|TWO_SIDED|95.0|-0.65|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.65|0.094
73907240|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.012|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.80|0.012
73907241|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.363|TWO_SIDED|95.0|-0.51|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.51|0.363
73964021|NCT00174382|147463961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.47||0.018||95.0|-2.05|-0.19|||Mixed Models Analysis|||||-0.19|-2.05|0.018
73964022|NCT00174382|147463961|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Mixed Models Analysis|||||||0.018
73907242|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.742|TWO_SIDED|95.0|-0.32|0.45|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.45|-0.32|0.742
73964023|NCT00174382|147463962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.62||0.182||95.0|-2.06|0.39|||Mixed Models Analysis|||||0.39|-2.06|0.182
73964024|NCT00174382|147463962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.68||0.114||95.0|-2.44|0.26|||Mixed Models Analysis|||||0.26|-2.44|0.114
73964025|NCT00174382|147463962|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Mixed Models Analysis|||||||0.038
73907243|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.19||0.436|TWO_SIDED|95.0|-0.53|0.23|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.53|0.436
73907244|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.038|TWO_SIDED|95.0|-0.79|-0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.79|0.038
73907245|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.332|TWO_SIDED|95.0|-0.57|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.57|0.332
73907246|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.284|TWO_SIDED|95.0|-0.47|0.14|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.47|0.284
73907247|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.224|TWO_SIDED|95.0|-0.5|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.50|0.224
73907248|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.79|-0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.79|0.002
73964026|NCT01828554|147463972|OTHER|||||||0.4882||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided|||The null hypothesis that the AUC from cycle 1 day 1 (based on ideal body weight) is equal to the AUC from cycle 1 day 9 (based on actual body weight) was tested against the alternative hypothesis that the AUCs are not equal. A linear mixed effect model with patient specific random effects was conducted||||0.4882
74025779|NCT01982630|147604289|OTHER||Difference of Least Squares Means|26.1|||||TWO_SIDED|90.0|2.02|50.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||50.19|2.02|
73907249|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.355|TWO_SIDED|95.0|-0.45|0.16|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.16|-0.45|0.355
73907250|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.172|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.172
73907251|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.882|TWO_SIDED|95.0|-0.36|0.31|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.36|0.882
73907252|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.63|0.04|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.63|0.084
73907253|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.405|TWO_SIDED|95.0|-0.47|0.19|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.47|0.405
73907254|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-0.99|-0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-0.99|<0.001
73907255|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.06|-0.42|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.06|<0.001
73907256|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.29|-0.64|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.64|-1.29|<0.001
73907257|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.29|-0.65|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.29|<0.001
73907258|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.95|-0.25|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.25|-0.95|<0.001
73907259|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.32|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.32|-1.02|<0.001
73964027|NCT01828554|147463973|OTHER|||||||0.7497||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided|||||||0.7497
73964028|NCT03951805|147463976|OTHER||Treatment difference|0.76||||0.7675|TWO_SIDED|95.0|-4.28|5.8|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||5.80|-4.28|0.7675
73964029|NCT03951805|147463976|OTHER||Treatment difference|7.08||||0.0051|TWO_SIDED|95.0|2.12|12.04|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||12.04|2.12|0.0051
74025780|NCT01982630|147604289|OTHER||Difference of Least Squares Means|3.45|||||TWO_SIDED|90.0|-20.23|27.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||27.14|-20.23|
73907260|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.22|-0.51|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.22|<0.001
73907261|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.31|-0.6|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.60|-1.31|<0.001
73907262|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.86|-0.18|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.86|0.003
73907263|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.24|-0.56|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.24|<0.001
73907264|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.26|-0.57|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.26|<0.001
73907265|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.41|-0.73|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.73|-1.41|<0.001
73907266|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
73907267|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.21|-0.47|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.47|-1.21|<0.001
73907268|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.36|-0.63|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.63|-1.36|<0.001
73907269|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.56|-0.83|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.83|-1.56|<0.001
73907270|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|-0.93|-0.23|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.93|0.001
73907271|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.24|-0.53|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.24|<0.001
73907272|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.24|-0.53|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.24|<0.001
73907273|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.70|-1.40|<0.001
73907274|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.17|-0.4|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.40|-1.17|<0.001
73907275|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.11|-0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.11|<0.001
73907276|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.32|-0.56|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.32|<0.001
73907277|NCT00809354|147344743|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.51|-0.75|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.75|-1.51|<0.001
73907278|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.887|TWO_SIDED|95.0|-0.33|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.33|0.887
73907279|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.046|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.62|0.046
73907280|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.16||0.771|TWO_SIDED|95.0|-0.26|0.35|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.26|0.771
73907281|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.16||0.032|TWO_SIDED|95.0|0.03|0.64|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.64|0.03|0.032
73907282|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.13|0.54|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.54|-0.13|0.223
73856567|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.5|||<|0.001|TWO_SIDED|95.0|5.25|7.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.76|5.25|<0.001
74025781|NCT01982630|147604289|OTHER||Difference of Least Squares Means|-26.45|||||TWO_SIDED|90.0|-49.96|-2.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-2.93|-49.96|
73856568|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.87|||<|0.001|TWO_SIDED|95.0|4.62|7.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.11|4.62|<0.001
73856569|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|6.63|||<|0.001|TWO_SIDED|95.0|5.38|7.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.88|5.38|<0.001
73856570|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.48|||<|0.001|TWO_SIDED|95.0|4.23|6.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.73|4.23|<0.001
73856571|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03||||0.022|TWO_SIDED|95.0|0.15|1.9||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.90|0.15|0.022
73856572|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.38|TWO_SIDED|95.0|-0.48|1.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.26|-0.48|0.380
73856573|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.15||||0.01|TWO_SIDED|95.0|0.28|2.03||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.03|0.28|0.010
73856574|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|21.52|||<|0.001|TWO_SIDED|95.0|17.17|25.87||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||25.87|17.17|<0.001
73856575|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|19.62|||<|0.001|TWO_SIDED|95.0|15.29|23.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||23.95|15.29|<0.001
73856576|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|22.24|||<|0.001|TWO_SIDED|95.0|17.89|26.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||26.59|17.89|<0.001
73856577|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|19.69|||<|0.001|TWO_SIDED|95.0|15.35|24.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||24.02|15.35|<0.001
73856578|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.83||||0.237|TWO_SIDED|95.0|-1.21|4.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.88|-1.21|0.237
73856579|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.965|TWO_SIDED|95.0|-3.09|2.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.95|-3.09|0.965
73907283|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.718|TWO_SIDED|95.0|-0.39|0.27|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.39|0.718
73964030|NCT03951805|147463976|OTHER||Treatment difference|5.01||||0.0519|TWO_SIDED|95.0|-0.04|10.05|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||10.05|-0.04|0.0519
74025782|NCT01982630|147604289|OTHER||Difference of Least Squares Means|-29.9|||||TWO_SIDED|90.0|-52.04|-7.77|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-7.77|-52.04|
73856580|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.56||||0.099|TWO_SIDED|95.0|-0.48|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.60|-0.48|0.099
73856581|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|29.93|||<|0.001|TWO_SIDED|95.0|21.14|38.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||38.73|21.14|<0.001
73856582|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|28.24|||<|0.001|TWO_SIDED|95.0|19.48|37.0||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||37.00|19.48|<0.001
73856583|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|33.1|||<|0.001|TWO_SIDED|95.0|24.31|41.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||41.89|24.31|<0.001
73856584|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|30.64|||<|0.001|TWO_SIDED|95.0|21.87|39.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||39.41|21.87|<0.001
73856585|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.71||||0.821|TWO_SIDED|95.0|-6.86|5.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.44|-6.86|0.821
73856586|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.4||||0.44|TWO_SIDED|95.0|-8.51|3.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.71|-8.51|0.440
73856587|NCT01559259|147258988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.46||||0.432|TWO_SIDED|95.0|-3.69|8.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||8.61|-3.69|0.432
73856588|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.08||||0.571|TWO_SIDED|95.0|-1.04|3.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||3.20|-1.04|0.571
73856589|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.98||||0.593|TWO_SIDED|95.0|-0.94|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.90|-0.94|0.593
73856590|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.65||||0.282|TWO_SIDED|95.0|-0.39|7.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.68|-0.39|0.282
73964031|NCT03684044|147464096|SUPERIORITY||Median Difference (Net)|-2.7||||0.4666|TWO_SIDED|95.0|-53.4|25.9|||Gehan Wilcoxon|The Gehan Wilcoxon test was used to analyze the TTCI data because the proportional hazards assumption was violated||||25.9|-53.4|0.4666
73964032|NCT03684044|147464097|SUPERIORITY|||||||0.6326|||||||Cochran-Mantel-Haenszel|Statistic was stratified by region, NEWS2 at baseline (≤7, \>7), and time from symptom onset to study treatment (≤48 hours, \>48 hours)||||||0.6326
73964033|NCT03684044|147464098|SUPERIORITY||Mean Difference (Net)|-6.8||||0.3272|TWO_SIDED|95.0|-50.9|17.7|||Gehan Wilcoxon|The Gehan Wilcoxon test was used to analyze the TTCI data because the proportional hazards assumption was violated||||17.7|-50.9|0.3272
73856591|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.16||||0.552|TWO_SIDED|95.0|-1.11|3.42||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.42|-1.11|0.552
73856592|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.01||||0.994|TWO_SIDED|95.0|-3.13|3.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.11|-3.13|0.994
73856593|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.23||||0.879|TWO_SIDED|95.0|-3.26|2.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.80|-3.26|0.879
73856594|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.33||||0.28|TWO_SIDED|95.0|-1.98|6.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||6.64|-1.98|0.280
73856595|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|33.67|||<|0.001|TWO_SIDED|95.0|24.54|42.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||42.81|24.54|<0.001
73856596|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|23.34||||0.003|TWO_SIDED|95.0|14.93|31.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.75|14.93|0.003
73856597|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|22.28||||0.005|TWO_SIDED|95.0|13.55|31.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.00|13.55|0.005
73856598|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|13.39||||0.035|TWO_SIDED|95.0|6.28|20.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.50|6.28|0.035
73856599|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|20.14||||0.001|TWO_SIDED|95.0|8.67|31.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.62|8.67|0.001
73856600|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.56||||0.088|TWO_SIDED|95.0|-1.39|20.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.51|-1.39|0.088
73856601|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.36||||0.1|TWO_SIDED|95.0|-1.73|20.45||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.45|-1.73|0.100
73907284|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.495|TWO_SIDED|95.0|-0.45|0.22|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.45|0.495
74025783|NCT01982630|147604289|OTHER||Difference of Least Squares Means|-56.0|||||TWO_SIDED|90.0|-79.53|-32.48|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-32.48|-79.53|
74025784|NCT01982630|147604290|OTHER||Difference of Least Squares Means|14.96|||||TWO_SIDED|90.0|-10.25|40.18|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||40.18|-10.25|
74025785|NCT01982630|147604290|OTHER||Difference of Least Squares Means|6.57|||||TWO_SIDED|90.0|-17.52|30.65|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||30.65|-17.52|
74025786|NCT01982630|147604290|OTHER||Difference of Least Squares Means|8.4|||||TWO_SIDED|90.0|-15.29|32.08|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||32.08|-15.29|
74025787|NCT01982630|147604290|OTHER||Difference of Least Squares Means|-35.23|||||TWO_SIDED|90.0|-58.75|-11.72|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.72|-58.75|
73907285|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.389|TWO_SIDED|95.0|-0.47|0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.47|0.389
73907286|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.035|TWO_SIDED|95.0|-0.68|-0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.68|0.035
73907287|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.155|TWO_SIDED|95.0|-0.56|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.56|0.155
73907288|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.876|TWO_SIDED|95.0|-0.35|0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.30|-0.35|0.876
73907289|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.864|TWO_SIDED|95.0|-0.33|0.39|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.39|-0.33|0.864
73907290|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.338|TWO_SIDED|95.0|-0.54|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.54|0.338
73907291|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.101|TWO_SIDED|95.0|-0.66|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.66|0.101
73907292|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.605|TWO_SIDED|95.0|-0.46|0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.46|0.605
73907293|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.013|TWO_SIDED|95.0|-0.78|-0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.78|0.013
73907294|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.84|0.005
73907295|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.199|TWO_SIDED|95.0|-0.57|0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.57|0.199
73907296|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.363|TWO_SIDED|95.0|-0.5|0.18|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.50|0.363
73907297|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.613|TWO_SIDED|95.0|-0.47|0.28|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.47|0.613
73964034|NCT03703336|147464125|NON_INFERIORITY|If the lower limit of the 95% confidence interval (CI) of the ratio of GMCs between the ROTAVIN and ROTAVIN-M1 groups were to be larger than 1/2, ROTAVIN was considered to be non-inferior to the licensed frozen formulation of the vaccine (ROTAVIN-M1).|GMC Ratio|1.38|||||TWO_SIDED|95.0|1.02|1.86|||||Log10-transformed IgA concentrations were used to construct a 2-sided 95% CI for the mean difference between the arms using t-distribution. The mean difference and 95% CI were exponentiated to obtain the GMC ratio and corresponding 95% CI.|||1.86|1.02|
73907298|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.19||0.416|TWO_SIDED|95.0|-0.53|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.53|0.416
73907299|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.143|TWO_SIDED|95.0|-0.66|0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.66|0.143
73907300|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.19||0.245|TWO_SIDED|95.0|-0.6|0.15|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.60|0.245
73907301|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.745|TWO_SIDED|95.0|-0.41|0.29|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|-0.41|0.745
73907302|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.062|TWO_SIDED|95.0|-0.69|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.69|0.062
73907303|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.014|TWO_SIDED|95.0|-0.8|-0.09|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.80|0.014
73907304|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.367|TWO_SIDED|95.0|-0.52|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.52|0.367
73907305|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.995|TWO_SIDED|95.0|-0.39|0.39|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.39|-0.39|0.995
73907306|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.735|TWO_SIDED|95.0|-0.46|0.32|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.46|0.735
73964035|NCT03703336|147464127|OTHER||Percentage Difference|6.0|||||TWO_SIDED|95.0|-3.57|15.87||||||||15.87|-3.57|
73907307|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.2||0.169|TWO_SIDED|95.0|-0.67|0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.67|0.169
73907308|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.295|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.60|0.295
73907309|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.284|TWO_SIDED|95.0|-0.47|0.14|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.47|0.284
73907310|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.224|TWO_SIDED|95.0|-0.5|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.50|0.224
73907311|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.79|-0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.79|0.002
73907312|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.355|TWO_SIDED|95.0|-0.45|0.16|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.16|-0.45|0.355
74025788|NCT01982630|147604290|OTHER||Difference of Least Squares Means|-43.63|||||TWO_SIDED|90.0|-65.77|-21.5|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-21.50|-65.77|
74025789|NCT01982630|147604290|OTHER||Difference of Least Squares Means|-50.2|||||TWO_SIDED|90.0|-73.72|-26.68|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-26.68|-73.72|
74025790|NCT01982630|147604291|OTHER||Difference of Least Squares Means|-31.2|||||TWO_SIDED|90.0|-56.59|-5.81|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-5.81|-56.59|
74025791|NCT01982630|147604291|OTHER||Difference of Least Squares Means|-25.12|||||TWO_SIDED|90.0|-50.25|0.01|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||0.01|-50.25|
74025792|NCT01982630|147604291|OTHER||Difference of Least Squares Means|-6.08|||||TWO_SIDED|90.0|-17.31|5.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||5.14|-17.31|
73907313|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.172|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.172
73907314|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.882|TWO_SIDED|95.0|-0.36|0.31|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.36|0.882
73907315|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.63|0.04|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.63|0.084
73907316|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.405|TWO_SIDED|95.0|-0.47|0.19|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.47|0.405
74025793|NCT01982630|147604292|OTHER||Difference of Least Squares Means|-27.48|||||TWO_SIDED|90.0|-52.87|-2.09|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-2.09|-52.87|
74025794|NCT01982630|147604292|OTHER||Difference of Least Squares Means|-30.59|||||TWO_SIDED|90.0|-55.72|-5.46|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-5.46|-55.72|
73907317|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.94|-0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.30|-0.94|<0.001
73907318|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.09|-0.44|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.44|-1.09|<0.001
73907319|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.3|-0.64|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.64|-1.30|<0.001
73907320|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.32|-0.67|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.67|-1.32|<0.001
73907321|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.30|-1.02|<0.001
73907322|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.99|-0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.27|-0.99|<0.001
73907323|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.19|-0.48|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.48|-1.19|<0.001
73907324|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.29|-0.57|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.29|<0.001
73964036|NCT03703336|147464128|OTHER||Percentage Difference|0.4|||||TWO_SIDED|95.0|-2.4|2.09||||||Percentage Difference on Day 1||2.09|-2.40|
74025795|NCT01982630|147604292|OTHER||Difference of Least Squares Means|3.11|||||TWO_SIDED|90.0|-8.11|14.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||14.34|-8.11|
74025796|NCT01982630|147604293|OTHER||Difference of Least Squares Means|4.59|||||TWO_SIDED|90.0|-20.88|30.06|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||30.06|-20.88|
74025797|NCT01982630|147604293|OTHER||Difference of Least Squares Means|-5.42|||||TWO_SIDED|90.0|-30.68|19.85|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||19.85|-30.68|
73856602|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|62.54|||<|0.001|TWO_SIDED|95.0|50.93|74.15||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.15|50.93|<0.001
73856603|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|51.66|||<|0.001|TWO_SIDED|95.0|39.5|63.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.82|39.50|<0.001
73856604|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.68|||<|0.001|TWO_SIDED|95.0|52.92|76.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||76.43|52.92|<0.001
73856605|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|52.03|||<|0.001|TWO_SIDED|95.0|40.43|63.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.63|40.43|<0.001
73856606|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.66||||0.138|TWO_SIDED|95.0|-3.04|24.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.35|-3.04|0.138
73856607|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.59||||0.935|TWO_SIDED|95.0|-14.71|13.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.52|-14.71|0.935
73856608|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|13.3||||0.063|TWO_SIDED|95.0|-0.57|27.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.17|-0.57|0.063
73856609|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.68|||<|0.001|TWO_SIDED|95.0|62.82|86.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.53|62.82|<0.001
73856610|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|63.18|||<|0.001|TWO_SIDED|95.0|50.42|75.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.95|50.42|<0.001
73856611|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.39|||<|0.001|TWO_SIDED|95.0|59.21|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.57|59.21|<0.001
73856612|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|60.5|||<|0.001|TWO_SIDED|95.0|47.89|73.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.11|47.89|<0.001
73964037|NCT03703336|147464128|OTHER||Percentage Difference|6.3|||||TWO_SIDED|95.0|-3.19|16.23||||||Percentage Difference on Day 85||16.23|-3.19|
73964038|NCT01066026|147464132|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|pilot study.|descritive variables|50.0|||<|0.0001|TWO_SIDED|95.0|5.0|95.0|||McNemar||50 was the percentage of hematomas expected for standard needle group.|||95|5|<0.0001
73964039|NCT02238483|147464149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.2371|TWO_SIDED|95.0|0.81|2.4|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|H0: Hazard Ratio (AZD7624/placebo) equals 1 vs. H1: Hazard Ratio does not equal 1.||2.40|0.81|0.2371
73964040|NCT02238483|147464150|SUPERIORITY_OR_OTHER||Rate Ratio|1.33|STANDARD_ERROR_OF_MEAN|0.33||0.249|TWO_SIDED|95.0|0.82|2.16|||regression, negative binomial||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.16|0.82|0.249
73907325|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.89|-0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.20|-0.89|0.002
73907326|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.32|-0.63|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.63|-1.32|<0.001
73907327|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.39|-0.7|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.70|-1.39|<0.001
73907328|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.55|-0.86|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.86|-1.55|<0.001
73907329|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.18|-0.43|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.18|<0.001
73964041|NCT02238483|147464151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.1261|TWO_SIDED|95.0|0.89|2.5|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.50|0.89|0.1261
74025798|NCT01982630|147604293|OTHER||Difference of Least Squares Means|10.01|||||TWO_SIDED|90.0|-1.77|21.78|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||21.78|-1.77|
73907330|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.28|-0.53|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.28|<0.001
73907331|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.33|-0.58|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.33|<0.001
73907332|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.56|-0.81|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.81|-1.56|<0.001
73907333|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.31|-1.02|<0.001
74025799|NCT01982630|147604294|OTHER||Difference of Least Squares Means|-14.98|||||TWO_SIDED|90.0|-40.53|10.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||10.57|-40.53|
74025800|NCT01982630|147604294|OTHER||Difference of Least Squares Means|-14.5|||||TWO_SIDED|90.0|-39.77|10.76|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||10.76|-39.77|
74025801|NCT01982630|147604294|OTHER||Difference of Least Squares Means|-0.48|||||TWO_SIDED|90.0|-12.47|11.52|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||11.52|-12.47|
73907334|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.08|-0.37|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.37|-1.08|<0.001
73907335|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.36|-0.65|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.36|<0.001
73907336|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.52|-0.81|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.81|-1.52|<0.001
73907337|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.29|-0.51|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.29|<0.001
73907338|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.3|-0.51|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.30|<0.001
73907339|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.36|-0.58|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.36|<0.001
73907340|NCT00809354|147344744|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.2|<|0.01|TWO_SIDED|95.0|-1.57|-0.79|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.79|-1.57|<0.01
73964042|NCT02238483|147464152|SUPERIORITY_OR_OTHER||Rate ratio|1.4|STANDARD_ERROR_OF_MEAN|0.33||0.157|TWO_SIDED|95.0|0.88|2.21|||regression, negative binomial|||||2.21|0.88|0.157
73964043|NCT02238483|147464153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.1529|TWO_SIDED|95.0|0.85|2.76|||Regression, Cox|||||2.76|0.85|0.1529
73964044|NCT02238483|147464154|SUPERIORITY_OR_OTHER||rate ratio|1.5|STANDARD_ERROR_OF_MEAN|0.4||0.129|TWO_SIDED|95.0|0.89|2.52|||regression, negative binomial|||||2.52|0.89|0.129
73964045|NCT02238483|147464155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.8543|TWO_SIDED|95.0|0.43|2.01|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.01|0.43|0.8543
73907341|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.469|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.469
73907342|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.387|TWO_SIDED|95.0|-0.18|0.07|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.18|0.387
73907343|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.887|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.11|0.887
73907344|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.01|0.084
73907345|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.018
73964046|NCT02238483|147464156|SUPERIORITY_OR_OTHER||rate ratio|1.12|STANDARD_ERROR_OF_MEAN|0.41||0.751|TWO_SIDED|95.0|0.55|2.29|||regression, negative binomial|||||2.29|0.55|0.751
73964047|NCT02238483|147464157|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.5381|TWO_SIDED|95.0|0.54|1.38|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||1.38|0.54|0.5381
73964048|NCT02238483|147464158|SUPERIORITY_OR_OTHER||rate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.19||0.44|TWO_SIDED|95.0|0.55|1.3|||regression, negative binomial|||||1.30|0.55|0.440
74025802|NCT01982630|147604295|OTHER||Difference of Least Squares Means|-43.68|||||TWO_SIDED|90.0|-65.81|-21.55|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-21.55|-65.81|
73907346|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.783
73907347|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.762|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.762
73907348|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.017
73907349|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.207|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.20|0.207
73907350|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.02|TWO_SIDED|95.0|-0.27|-0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.27|0.020
74025803|NCT01982630|147604295|OTHER||Difference of Least Squares Means|-47.4|||||TWO_SIDED|90.0|-69.35|-25.45|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-25.45|-69.35|
74025804|NCT01982630|147604295|OTHER||Difference of Least Squares Means|3.72|||||TWO_SIDED|90.0|-5.76|13.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||13.19|-5.76|
73907351|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.941|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.13|0.941
73907352|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.494|TWO_SIDED|95.0|-0.18|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.18|0.494
73907353|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.089|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.089
73907354|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.467|TWO_SIDED|95.0|-0.18|0.08|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.18|0.467
73907355|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.774|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.774
73964049|NCT02238483|147464159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.5474|TWO_SIDED|95.0|-1.6|0.85|||Mixed Models Analysis||LSMean difference for overall treatment effect. Negative values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.85|-1.60|0.5474
73964050|NCT02238483|147464160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.83||||0.6352|TWO_SIDED|95.0|-2.62|4.29|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||4.29|-2.62|0.6352
73964051|NCT02238483|147464161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.2694|TWO_SIDED|95.0|-0.34|0.1|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.10|-0.34|0.2694
73964052|NCT02238483|147464162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.5144|TWO_SIDED|95.0|-0.03|0.07|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.07|-0.03|0.5144
73964053|NCT02238483|147464163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.5416|TWO_SIDED|95.0|-0.1|0.05|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.05|-0.10|0.5416
73907356|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.315|TWO_SIDED|95.0|-0.06|0.19|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.06|0.315
73907357|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.088|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.088
73907358|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.084|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.084
73907359|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.066|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.066
73907360|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.073|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.073
73907361|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.682|TWO_SIDED|95.0|-0.16|0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.16|0.682
73907362|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.014|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.014
73907363|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.027|TWO_SIDED|95.0|-0.28|-0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.28|0.027
73907364|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.871|TWO_SIDED|95.0|-0.14|0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.14|0.871
73907365|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.301|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.301
73907366|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.181|TWO_SIDED|95.0|-0.23|0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.23|0.181
73907367|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.3|-0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.30|0.013
73907368|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.031|TWO_SIDED|95.0|-0.28|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.28|0.031
73907369|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.874|TWO_SIDED|95.0|-0.15|0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.15|0.874
73907370|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.447|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.447
73907371|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.059|TWO_SIDED|95.0|-0.27|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.27|0.059
74025805|NCT01982630|147604296|OTHER||Difference of Least Squares Means|-34.01|||||TWO_SIDED|90.0|-56.14|-11.88|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.88|-56.14|
73907372|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.196|TWO_SIDED|95.0|-0.23|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.23|0.196
73907373|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.36|TWO_SIDED|95.0|-0.18|0.06|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.18|0.360
73907374|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.845|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.845
73907375|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.076|TWO_SIDED|95.0|-0.23|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.23|0.076
73907376|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.957|TWO_SIDED|95.0|-0.12|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.12|0.957
73907377|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.404|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.404
73907378|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.03|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.03|0.128
74025806|NCT01982630|147604296|OTHER||Difference of Least Squares Means|-39.2|||||TWO_SIDED|90.0|-61.15|-17.26|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-17.26|-61.15|
73907379|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.577|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.577
73907380|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED|95.0|-0.01|0.25|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.01|0.068
73907381|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.011|TWO_SIDED|95.0|-0.28|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.28|0.011
73907382|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.36|<0.001
73907383|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.43|-0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.43|<0.001
73907384|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.36|-0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.36|<0.001
73907385|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.043|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.27|0.043
73907386|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.31|-0.05|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.31|0.007
73907387|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.38|-0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.38|<0.001
73907388|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.36|-0.1|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.36|<0.001
73907389|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.074|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.074
74025807|NCT01982630|147604296|OTHER||Difference of Least Squares Means|5.2|||||TWO_SIDED|90.0|-4.28|14.67|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||14.67|-4.28|
73907390|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.37|<0.001
73907391|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.37|<0.001
73907392|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.49|-0.23|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.49|<0.001
73907393|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.236|TWO_SIDED|95.0|-0.21|0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.21|0.236
73907394|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.112|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.24|0.112
73907395|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.38|-0.11|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.38|<0.001
73907396|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.39|-0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.39|<0.001
73907397|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.059|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.26|0.059
73907398|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.33|-0.07|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.33|0.003
73907399|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.001|TWO_SIDED|95.0|-0.36|-0.09|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.36|0.001
73907400|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.51|-0.24|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-0.51|<0.001
73907401|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.055|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.055
73907402|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.038|TWO_SIDED|95.0|-0.28|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.28|0.038
73907403|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.33|-0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.33|0.007
73907404|NCT00809354|147344745|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.42|<0.001
73907405|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.469|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.469
73907406|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.387|TWO_SIDED|95.0|-0.18|0.07|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.18|0.387
73907407|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.887|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.11|0.887
73907408|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.01|0.084
73907409|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.018
73907410|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.783
73964054|NCT02238483|147464164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.1965|TWO_SIDED|95.0|0.0|0.02|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.02|0.00|0.1965
73907411|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.762|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.762
73907412|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.017
73907413|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.091|TWO_SIDED|95.0|-0.23|0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.23|0.091
73907414|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.009|TWO_SIDED|95.0|-0.29|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.29|0.009
73907415|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.835|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.835
73907416|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.463|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.463
73907417|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.713|TWO_SIDED|95.0|-0.16|0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.16|0.713
73907418|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.267|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.267
73907419|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.552|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.552
73907420|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.885|TWO_SIDED|95.0|-0.12|0.14|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.12|0.885
73907421|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.47|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.26|0.47
73907422|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.056|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.26|0.056
73907423|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.117|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.117
73964055|NCT02574455|147464168|OTHER||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.305|0.492||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.|Log Rank|||||0.492|0.305|<0.0001
74025808|NCT01982630|147604297|OTHER||Difference of Least Squares Means|-23.73|||||TWO_SIDED|90.0|-45.89|-1.56|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-1.56|-45.89|
73964056|NCT02574455|147464169|OTHER||Hazard Ratio (HR)|0.413|||<|0.0001|TWO_SIDED|95.0|0.33|0.517||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.|Log Rank|||||0.517|0.330|<0.0001
73907424|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.106|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.24|0.106
73907425|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.673|TWO_SIDED|95.0|-0.16|0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.16|0.673
73907426|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.089|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.089
73907427|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.065|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.26|0.065
73907428|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.567|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.567
73907429|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.135|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.135
73907430|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.094|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.094
73907431|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.055|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.055
73964057|NCT02574455|147464170|OTHER||Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.39|0.592||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||||0.592|0.390|<0.0001
74025809|NCT01982630|147604297|OTHER||Difference of Least Squares Means|-33.95|||||TWO_SIDED|90.0|-55.93|-11.98|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.98|-55.93|
74025810|NCT01982630|147604297|OTHER||Difference of Least Squares Means|10.23|||||TWO_SIDED|90.0|0.56|19.89|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||19.89|0.56|
73907432|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.087|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.087
73907433|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.542|TWO_SIDED|95.0|-0.18|0.1|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.18|0.542
73907434|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.643|TWO_SIDED|95.0|-0.17|0.11|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.17|0.643
73907435|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.301|TWO_SIDED|95.0|-0.21|0.07|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.21|0.301
73907436|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.237|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.22|0.237
73907437|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.36|TWO_SIDED|95.0|-0.18|0.06|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.18|0.360
73907438|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.854|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.854
73907439|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.076|TWO_SIDED|95.0|-0.23|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.23|0.076
73907440|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.957|TWO_SIDED|95.0|-0.12|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.12|0.957
73907441|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.404|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.404
73964058|NCT02574455|147464171|OTHER||Hazard Ratio (HR)|0.514|||<|0.0001|TWO_SIDED|95.0|0.422|0.625||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||||0.625|0.422|<0.0001
73964059|NCT02574455|147464172|OTHER||Odds Ratio (OR)|10.859|||<|0.0001|TWO_SIDED|95.0|5.59|21.095|||Cochran-Mantel-Haenszel|||ORR by IRC Assessment||21.095|5.590|<0.0001
73964060|NCT02574455|147464172|OTHER||Odds Ratio (OR)|7.363|||<|0.0001|TWO_SIDED|95.0|4.063|13.341|||Cochran-Mantel-Haenszel|||ORR by Investigator Assessment||13.341|4.063|<0.0001
73964061|NCT02574455|147464175|OTHER||Hazard Ratio (HR)|0.407||||0.0683|TWO_SIDED|95.0|0.15|1.107||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.|Log Rank|||DOR by IRC Assessment||1.107|0.150|0.0683
74085121|NCT00407745|147723834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.383||0.3312|TWO_SIDED|95.0|-1.13|0.38||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 1 - Burning pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.38|-1.13|0.3312
74085122|NCT00407745|147723834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.377||0.0976|TWO_SIDED|95.0|-1.37|0.12||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 2 - Squeezing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.12|-1.37|0.0976
74085123|NCT00407745|147723834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.393||0.0538|TWO_SIDED|95.0|-1.54|0.01||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 3 - Pain like pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.01|-1.54|0.0538
74085124|NCT00407745|147723834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.389||0.3239|TWO_SIDED|95.0|-1.15|0.38||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 5 - Electric shocks~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.38|-1.15|0.3239
74085125|NCT00407745|147723834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.376||0.1912|TWO_SIDED|95.0|-1.23|0.25||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 6 - Stabbing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.25|-1.23|0.1912
74085126|NCT00407745|147723834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.353||0.672|TWO_SIDED|95.0|-0.55|0.85||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 8 - By light touching~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.85|-0.55|0.6720
74025811|NCT01982630|147604298|OTHER||Difference of Least Squares Means|-23.49|||||TWO_SIDED|90.0|-45.65|-1.32|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-1.32|-45.65|
74025812|NCT01982630|147604298|OTHER||Difference of Least Squares Means|-29.76|||||TWO_SIDED|90.0|-51.74|-7.79|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-7.79|-51.74|
74025813|NCT01982630|147604298|OTHER||Difference of Least Squares Means|6.27|||||TWO_SIDED|90.0|-3.39|15.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||15.93|-3.39|
74025814|NCT03959189|147604312|SUPERIORITY||mixed effects model|-0.0796|STANDARD_ERROR_OF_MEAN|0.2768||0.7746|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following ERX-963 versus placebo. In the primary analysis of SSS, the cohort 1 and cohort 2 data were combined for ERX-963 and placebo treatments.||0.5|-0.6|0.7746
74025815|NCT03959189|147604312|SUPERIORITY||mixed effects model|-0.2608|STANDARD_ERROR_OF_MEAN|0.3589||0.47|TWO_SIDED|95.0|-1.0|0.5|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following 1 mg ERX-963 versus placebo. In this analysis of SSS, the effect of 1 mg ERX-963 treatment was compared to the effect of placebo treatment.||0.5|-1.0|0.4700
74025816|NCT03959189|147604312|SUPERIORITY||mixed effects model|0.1016|STANDARD_ERROR_OF_MEAN|0.4272||0.8127|TWO_SIDED|95.0|-0.8|1.0|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following 2 mg ERX-963 versus placebo. In this analysis of SSS, the effect of 2 mg ERX-963 treatment was compared to the effect of placebo treatment.||1.0|-0.8|0.8127
74025817|NCT03248128|147604337|SUPERIORITY||Least Square Mean Difference|0.083|||<|0.001|TWO_SIDED|95.0|0.037|0.129|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||0.129|0.037|<0.001
73856613|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.43||||0.027|TWO_SIDED|95.0|1.97|26.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.89|1.97|0.027
74025818|NCT03248128|147604338|SUPERIORITY||Least Square Mean Difference|3.2||||0.228|TWO_SIDED|95.0|-2.0|8.4|||ANCOVA|Analysis was performed using analysis of covariance (ANCOVA) with covariates of baseline, region, sex, age and treatment.||||8.4|-2.0|0.228
74025819|NCT03248128|147604339|SUPERIORITY||Least Square Mean Difference|6.2||||0.011|TWO_SIDED|95.0|1.4|10.9|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||10.9|1.4|0.011
73907442|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.03|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.03|0.128
73907443|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.577|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.577
73907444|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED|95.0|-0.01|0.25|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.01|0.068
73907445|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.016|TWO_SIDED|95.0|-0.27|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.27|0.016
73907446|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.38|<0.001
73907447|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.44|-0.19|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.19|-0.44|<0.001
73907448|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.39|-0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.39|<0.001
73907449|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.037|TWO_SIDED|95.0|-0.27|-0.01|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.27|0.037
74025820|NCT03248128|147604340|SUPERIORITY||Least Square Mean Difference|0.073||||0.002|TWO_SIDED|95.0|0.028|0.118|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||0.118|0.028|0.002
74025821|NCT03248128|147604341|SUPERIORITY||Least Square Mean Difference|-0.3||||0.87|TWO_SIDED|95.0|-4.5|3.8|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||3.8|-4.5|0.870
74025822|NCT03248128|147604342|SUPERIORITY||Least Square Mean Difference|0.0||||0.988|TWO_SIDED|95.0|-4.2|4.1|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||4.1|-4.2|0.988
74025823|NCT03248128|147604343|SUPERIORITY||Least Square Mean Difference|0.035||||0.124|TWO_SIDED|0.95|-0.01|0.08|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.080|-0.010|0.124
74025824|NCT03248128|147604344|SUPERIORITY||Least Square Mean Difference|-0.01||||0.91|TWO_SIDED|95.0|-0.1|0.09|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.09|-0.10|0.910
74025825|NCT03248128|147604345|SUPERIORITY||Least Square Mean Difference|1.3||||0.614|TWO_SIDED|95.0|-3.6|6.2|||ANCOVA|Analysis performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||6.2|-3.6|0.614
74025826|NCT03248128|147604346|SUPERIORITY||Least Square Mean Difference|1.3||||0.594|TWO_SIDED|95.0|-3.6|6.3|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||6.3|-3.6|0.594
73907450|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.015|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.015
73907451|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||0.07|-0.22||||0.001|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.35|0.001
73907452|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.34|-0.07|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.34|0.002
74025827|NCT03248128|147604347|SUPERIORITY||Least Square Mean Difference|0.028||||0.226|TWO_SIDED|95.0|-0.017|0.073|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.073|-0.017|0.226
74025828|NCT03248128|147604348|SUPERIORITY||Least Square Mean Difference|-0.02||||0.663|TWO_SIDED|95.0|-0.13|0.09|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.09|-0.13|0.663
73907453|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.042|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.27|0.042
73907454|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.14|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.40|<0.001
73907455|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.40|<0.001
73907456|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-0.50|<0.001
73907457|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.182|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.22|0.182
73907458|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.08|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.080
73907459|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.34|-0.07|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.34|0.002
73907460|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.37|<0.001
73907461|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.016|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.016
73907462|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.40|<0.001
73907463|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.42|-0.15|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.42|<0.001
73907464|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.53|-0.27|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.27|-0.53|<0.001
73907465|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.032|TWO_SIDED|95.0|-0.29|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.29|0.032
73907466|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.006|TWO_SIDED|95.0|-0.33|-0.06|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.33|0.006
73907467|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.009|TWO_SIDED|95.0|-0.32|-0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.32|0.009
73907468|NCT00809354|147344746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.41|<0.001
73907469|NCT01480089|147344810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.308|STANDARD_ERROR_OF_MEAN|0.777||0.098|TWO_SIDED|95.0|-2.83|0.214|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 2 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).||0.214|-2.830|.098
73907470|NCT01480089|147344811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.53||0.9|TWO_SIDED|95.0|-1.103|0.973|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 12 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).||0.973|-1.103|.90
73907471|NCT03198078|147344823|SUPERIORITY||LS mean difference|-5.33||||0.0136|TWO_SIDED|95.0|-9.55|-1.1||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||-1.10|-9.55|0.0136
73907472|NCT03198078|147344823|SUPERIORITY||LS mean difference|-6.53||||0.0032|TWO_SIDED|95.0|-10.8|-2.21||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||-2.21|-10.8|0.0032
73907473|NCT03198078|147344824|SUPERIORITY||LS mean difference|-1.44||||0.0205|TWO_SIDED|95.0|-2.65|-0.22||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Positive Sub-scale Score||-0.22|-2.65|0.0205
73907474|NCT03198078|147344824|SUPERIORITY||LS mean difference|-2.15||||0.0008|TWO_SIDED|95.0|-3.4|-0.91||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Positive Sub-scale Score||-0.91|-3.40|0.0008
73907475|NCT03198078|147344824|SUPERIORITY||LS mean difference|-0.88||||0.136|TWO_SIDED|95.0|-2.04|0.28||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Negative Sub-scale Score||0.28|-2.04|0.1360
73964062|NCT02574455|147464175|OTHER||Hazard Ratio (HR)|0.212|||<|0.0001|TWO_SIDED|95.0|0.103|0.435||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.|Log Rank|||DOR by Investigator Assessment||0.435|0.103|<0.0001
73964063|NCT02574455|147464176|OTHER||Hazard Ratio (HR)|0.317|||<|0.0001|TWO_SIDED|95.0|0.248|0.404||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||TTP by Investigator Assessment||0.404|0.248|<0.0001
73964064|NCT02574455|147464177|OTHER||Hazard Ratio (HR)|0.406|||<|0.0001|TWO_SIDED|95.0|0.315|0.525||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||TTP by IRC Assessment||0.525|0.315|<0.0001
73964065|NCT02574455|147464178|OTHER||Odds Ratio (OR)|8.543|||<|0.0001|TWO_SIDED|95.0|5.055|14.437|||Cochran-Mantel-Haenszel|||CBR by IRC Assessment||14.437|5.055|<0.0001
73907476|NCT03198078|147344824|SUPERIORITY||LS mean difference|-0.95||||0.1158|TWO_SIDED|95.0|-2.14|0.24||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Negative Sub-scale Score||0.24|-2.14|0.1158
73907477|NCT03198078|147344825|SUPERIORITY||Ratio of Response Rate|1.55||||0.0111|TWO_SIDED|95.0|1.09|2.2|||Cochran-Mantel-Haenszel|P-value was analyzed by Cochran-Mantel-Haenszel (CMH) general association test controlling for (pooled) centers.||||2.20|1.09|0.0111
73907478|NCT03198078|147344825|SUPERIORITY||Ratio of Response Rate|1.51||||0.0224|TWO_SIDED|95.0|1.06|2.16|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||2.16|1.06|0.0224
73907479|NCT03198078|147344826|SUPERIORITY||Ratio of Remission Rate|1.18||||0.4415|TWO_SIDED|95.0|0.77|1.81|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||1.81|0.77|0.4415
73907480|NCT03198078|147344826|SUPERIORITY||Ratio of Remission Rate|1.48||||0.0472|TWO_SIDED|95.0|1.01|2.16|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||2.16|1.01|0.0472
73907481|NCT03198078|147344827|SUPERIORITY||LS mean difference|2.48||||0.0854|TWO_SIDED|95.0|-0.35|5.31||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||5.31|-0.35|0.0854
73907482|NCT03198078|147344827|SUPERIORITY||LS mean difference|3.99||||0.0072|TWO_SIDED|95.0|1.09|6.88||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||6.88|1.09|0.0072
73907483|NCT03198078|147344828|SUPERIORITY||LS mean difference|-0.11||||0.3589|TWO_SIDED|95.0|-0.36|0.13||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||0.13|-0.36|0.3589
73907484|NCT03198078|147344828|SUPERIORITY||LS mean difference|-0.2||||0.1118|TWO_SIDED|95.0|-0.45|0.05||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||0.05|-0.45|0.1118
73964066|NCT02574455|147464178|OTHER||Odds Ratio (OR)|7.492|||<|0.0001|TWO_SIDED|95.0|4.54|12.364|||Cochran-Mantel-Haenszel|||CBR by Investigator Assessment||12.364|4.540|<0.0001
73964067|NCT02677896|147464182|SUPERIORITY||Cox hazard ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.3|0.5||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|rPFS Treatment Comparison||0.50|0.30|<0.0001
73907485|NCT03198078|147344829|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.0287|TWO_SIDED|95.0|-0.56|-0.03|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH row mean scores differ test controlling for study center.||||-0.03|-0.56|0.0287
73907486|NCT03198078|147344829|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0184|TWO_SIDED|95.0|-0.62|-0.06|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH row mean scores differ test controlling for study center.||||-0.06|-0.62|0.0184
73964068|NCT02677896|147464183|SUPERIORITY||Cox proportional hazards model|0.39|||<|0.0001|TWO_SIDED|95.0|0.3|0.5|||Log Rank|||rPFS Treatment Comparision||0.50|0.30|<0.0001
73964069|NCT02677896|147464184|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.53|0.81|||Log Rank|P-value from stratified log-rank test.|Significance level is 0.04. Hazard ratio and 95 % CI are estimated by cox proportional hazards model.|||0.81|0.53|<0.0001
73907487|NCT03198078|147344840|SUPERIORITY||LS mean difference|0.07|||||TWO_SIDED|95.0|-0.24|0.39|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.39|-0.24|
73907488|NCT03198078|147344840|SUPERIORITY||LS mean difference|0.18|||||TWO_SIDED|95.0|-0.14|0.51|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.51|-0.14|
73907489|NCT03198078|147344841|SUPERIORITY||LS mean difference|-0.06|||||TWO_SIDED|95.0|-0.3|0.18|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.18|-0.30|
73907490|NCT03198078|147344841|SUPERIORITY||LS mean difference|0.11|||||TWO_SIDED|95.0|-0.13|0.36|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.36|-0.13|
73907491|NCT03198078|147344842|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.08|0.09|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.09|-0.08|
73964070|NCT02677896|147464185|SUPERIORITY||Cox hazard ratio|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.26||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to PSA Progression Treatment Comparison||0.26|0.13|<0.0001
73964071|NCT02677896|147464186|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.31|0.48|||||Hazard ratio and 95 % CI are estimated by cox proportional hazards model.|||0.48|0.31|
73964072|NCT02677896|147464187|SUPERIORITY||Difference in rate|50.5|||<|0.0001|TWO_SIDED|95.0|45.3|55.7||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||PSA Undetectable Rate Treatment Comparison||55.7|45.3|<0.0001
73964073|NCT02677896|147464188|SUPERIORITY||Difference in rate|19.3|||<|0.0001|TWO_SIDED|95.0|10.4|28.2||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||ORR Treatment Comparison||28.2|10.4|<0.0001
73907492|NCT03198078|147344842|SUPERIORITY||LS mean difference|0.05|||||TWO_SIDED|95.0|-0.04|0.14|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.14|-0.04|
73907493|NCT02607930|147344864|NON_INFERIORITY|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-0.6|||||TWO_SIDED|95.002|-4.8|3.6|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.6|-4.8|
73907494|NCT02607930|147344864|SUPERIORITY|||||||0.78|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.78
73907495|NCT02607930|147344865|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-6.9|3.1|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.1|-6.9|
73907496|NCT02607930|147344865|OTHER|||||||0.45|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.45
73907497|NCT02607930|147344866|OTHER||Difference in Percentages|-2.6|||||TWO_SIDED|95.0|-8.5|3.4|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.4|-8.5|
73907498|NCT02607930|147344866|OTHER|||||||0.39|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.39
73907499|NCT02607930|147344867|OTHER||Difference in Percentages|0.4|||||TWO_SIDED|95.0|-4.8|5.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||5.6|-4.8|
74085127|NCT00407745|147723834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.33||0.7821|TWO_SIDED|95.0|-0.74|0.56||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 9 - By pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.56|-0.74|0.7821
73907500|NCT02607930|147344867|OTHER|||||||0.87|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.87
73907501|NCT02607930|147344868|OTHER||Difference in Percentages|-1.2|||||TWO_SIDED|95.0|-6.9|4.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||4.6|-6.9|
73907502|NCT02607930|147344868|OTHER|||||||0.69|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.69
73907503|NCT02607930|147344869|OTHER||Difference in Percentages|-4.2|||||TWO_SIDED|95.0|-10.5|2.1|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||2.1|-10.5|
73907504|NCT02607930|147344869|OTHER|||||||0.19|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.19
73907505|NCT02607930|147344870|OTHER||Difference in LSM|-0.03||||0.48|TWO_SIDED|95.0|-0.12|0.06|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.06|-0.12|0.48
73907506|NCT02607930|147344871|OTHER||Difference in LSM|0.0||||0.99|TWO_SIDED|95.0|-0.09|0.09|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.09|-0.09|0.99
73964074|NCT02677896|147464189|SUPERIORITY||Cox hazard ratio|0.88||||0.2162|TWO_SIDED|95.0|0.72|1.08||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to Deterioration of Urinary Symptoms Treatment Comparison||1.08|0.72|0.2162
74085128|NCT00407745|147723834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.352||0.6851|TWO_SIDED|95.0|-0.84|0.55||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 10 - By something cold~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.55|-0.84|0.6851
73907507|NCT02607930|147344872|OTHER||Difference in LSM|0.01||||0.88|TWO_SIDED|95.0|-0.08|0.1|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.10|-0.08|0.88
73907508|NCT02607930|147344873|OTHER||Difference in LSM|6.0||||0.69|TWO_SIDED|95.0|-24.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||36|-24|0.69
73907509|NCT02607930|147344874|OTHER||Difference in LSM|-1.0||||0.94|TWO_SIDED|95.0|-39.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||36|-39|0.94
73964075|NCT02677896|147464190|SUPERIORITY||Cox hazard ratio|0.52||||0.0026|TWO_SIDED|95.0|0.33|0.8|||Log Rank|||Time to SSE Treatment Comparison||0.80|0.33|0.0026
73964076|NCT02677896|147464191|SUPERIORITY||Cox hazard ratio|0.28|||<|0.0001|TWO_SIDED|95.0|0.22|0.36|||Log Rank|||Time to Castration Resistance Treatment Comparison||0.36|0.22|<0.0001
73907510|NCT02607930|147344875|OTHER||Difference in LSM|-20.0||||0.3|TWO_SIDED|95.0|-59.0|18.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||18|-59|0.30
73907511|NCT02607930|147344876|OTHER||Difference in LSM|0.346||||0.092|TWO_SIDED|95.0|-0.057|0.748|||ANOVA|||||0.748|-0.057|0.092
73907512|NCT02607930|147344877|OTHER||Difference in LSM|0.135||||0.59|TWO_SIDED|95.0|-0.356|0.625|||ANOVA|||||0.625|-0.356|0.59
73907513|NCT02607930|147344878|OTHER||Difference in LSM|0.271||||0.39|TWO_SIDED|95.0|-0.351|0.893|||ANOVA|||||0.893|-0.351|0.39
73907514|NCT02607930|147344879|OTHER||Difference in LSM|-0.221||||0.41|TWO_SIDED|95.0|-0.741|0.3|||ANOVA|||||0.300|-0.741|0.41
73907515|NCT02607930|147344880|OTHER||Difference in LSM|-0.485||||0.14|TWO_SIDED|95.0|-1.126|0.155|||ANOVA|||||0.155|-1.126|0.14
73907516|NCT02607930|147344881|OTHER||Difference in LSM|-0.406||||0.26|TWO_SIDED|95.0|-1.119|0.307|||ANOVA|||||0.307|-1.119|0.26
73907517|NCT01050543|147344888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|||<|0.0001|TWO_SIDED|95.0|6.8|9.6|||ANOVA|||To evaluate the efficacy of sugammadex compared to the efficacy of neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a 2-way ANOVA model adjusted for trial site.||9.6|6.8|<0.0001
73907518|NCT00570765|147344889|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment arms compared using 2-sided Wilcoxon-Mann-Whitney test at 5% significance level. Treatment groups were pairwise compared versus placebo.||Hierarchical testing strategy was proposed to account for multiple comparisons. Statistical significance was evaluated as follows: if statistical significance at alpha=0.05 is shown for the 10 mg OCA versus placebo, then the statistical significance at alpha=0.05 for the 50 mg OCA versus placebo was evaluated. If no statistical significance was shown at alpha=0.05 at the first step, then the subsequent comparison was not considered statistically significant.||||<0.0001
73907519|NCT00570765|147344890|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment arms compared using 2-sided Wilcoxon-Mann-Whitney test at 5% significance level. Treatment groups were pairwise compared versus placebo.||||||<0.0001
73907520|NCT00570765|147344891|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Tx arms will be compared using the 2-sided Wilcoxon-Mann-Whitney test, at 5% significance level. Tx groups will be pairwise compared vs. placebo.||||||<0.01
73907521|NCT03711266|147344904|OTHER||Mean Difference (Final Values)|31.4|||<|0.001|TWO_SIDED|95.0|18.5|44.3|||t-test, 2 sided|||Thirty patients were included in the final analysis. The analysis strategy was intent-to-treat, and multiple imputation was used to impute missing follow-up data. We included auxiliary variables that were correlated with the missing variables at r \> 0.4 (Enders, 2010).||44.3|18.5|<.001
73907522|NCT00057876|147344908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|ONE_SIDED|95.0|||||Log Rank|||Log rank test is conducted for OS to see whether the two treatment arms are different in their overall survival probabilities.||||0.017
73907523|NCT00057876|147344909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|ONE_SIDED|95.0|||||Log Rank|||||||0.25
73964077|NCT02677896|147464192|SUPERIORITY||Cox hazard ratio|0.96||||0.6548|TWO_SIDED|95.0|0.81|1.14|||Log Rank|||Time to Deterioration of QoL in FACT-P Treatment Comparison||1.14|0.81|0.6548
73964078|NCT02677896|147464193|SUPERIORITY||Cox hazard ratio|0.92||||0.2715|TWO_SIDED|95.0|0.78|1.07|||Log Rank|||Time to Pain Progression Based on BPI-SF Treatment Comparison||1.07|0.78|0.2715
73964079|NCT00567489|147464194|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
73964080|NCT00567489|147464194|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
73964081|NCT00567489|147464195|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
73964082|NCT00567489|147464195|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
74025829|NCT00002850|147604394|SUPERIORITY_OR_OTHER|||||||0.218|||||||Fisher Exact|Target accrual=70 patients per arm to provide 92% power to detect a difference of 0.31 vs. 0.08 in the proportion of patients with serious infection.||"H0: There is no significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.~Ha: There is a significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level."||||0.218
74025830|NCT00955110|147604397|SUPERIORITY_OR_OTHER||Least Square Means Difference|-28.8|||<|0.001|TWO_SIDED|95.0|-41.6|-16.0||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||-16.0|-41.6|<0.001
73964083|NCT00567489|147464197|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
74025831|NCT00955110|147604397|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-50.5|||<|0.001|TWO_SIDED|95.0|-63.4|-37.5||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||-37.5|-63.4|<0.001
73907524|NCT00057876|147344910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Fisher Exact|||Compare objective response rate (CR+PR) between two treatment groups||||0.99
73907525|NCT02617888|147344930|SUPERIORITY||Slope|0.08|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
73907526|NCT02907268|147344958|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73907527|NCT02907268|147344959|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73907528|NCT02907268|147344960|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73907529|NCT00457366|147344970|OTHER|We used an analysis of covariance (ANCOVA) with baseline as the covariate to analyze the PANSS-EC at hour 2.|||||>|0.05|||||||ANCOVA|||||||>0.05
73907530|NCT01916967|147344971|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-1.17|||<|0.001|TWO_SIDED|95.0|-1.69|-0.65|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in least squares (LS) means of Desloratadine 5 mg and Placebo||-0.65|-1.69|<0.001
73907531|NCT01916967|147344971|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-1.13|||<|0.001|TWO_SIDED|95.0|-1.66|-0.61|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in LS means of Desloratadine 10 mg and Placebo||-0.61|-1.66|<0.001
73907532|NCT00568685|147344982|SUPERIORITY_OR_OTHER|||||||0.0048||95.0||||This is the p value for CGI-ADHD-S score change at endpoint|Mixed Models Analysis|||||||0.0048
73907533|NCT00568685|147344983|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||This is the p value for CGI-ADHD-I score change at endpoint|Mixed Models Analysis|||||||0.0153
73907534|NCT00568685|147344984|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P-value relates to the sum of adverse events leading to discontinuation.|Fisher Exact|||||||.4500
73907535|NCT00568685|147344985|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|||||||0.0240
73907536|NCT00568685|147344987|SUPERIORITY_OR_OTHER|||||||0.8005||95.0||||This is the p value for heart rate change at endpoint|ANOVA|||||||0.8005
73907537|NCT00568685|147344988|SUPERIORITY_OR_OTHER|||||||0.4128||95.0||||This is the p value for temperature change at endpoint|ANOVA|||||||0.4128
73907538|NCT00568685|147344989|SUPERIORITY_OR_OTHER|||||||0.9761||95.0||||This is the p value for systolic change at endpoint|ANOVA|||||||0.9761
73907539|NCT00568685|147344989|SUPERIORITY_OR_OTHER|||||||0.6419||95.0||||This is the p value for diastolic change at endpoint|ANOVA|||||||0.6419
73907540|NCT00568685|147344990|SUPERIORITY_OR_OTHER|||||||0.2213||95.0||||This is the p value for weight change at endpoint|ANOVA|||||||0.2213
73907541|NCT02038452|147344991|SUPERIORITY||Mean Difference (Final Values)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.48|-0.16|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.16|-0.48|<0.001
73907542|NCT02038452|147344992|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.001|TWO_SIDED|95.0|-0.53|-0.17|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.17|-0.53|<0.001
73907543|NCT02038452|147344993|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.003|TWO_SIDED|95.0|-0.43|-0.09|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.09|-0.43|0.003
73907544|NCT02038452|147344994|SUPERIORITY||Mean Difference (Final Values)|-0.97||||0.005|TWO_SIDED|95.0|-1.64|-0.3|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.30|-1.64|0.005
73907545|NCT02038452|147344995|SUPERIORITY||Odds Ratio (OR)|0.44||||0.018|TWO_SIDED|95.0|0.22|0.87|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.87|0.22|0.018
73907546|NCT02038452|147344998|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.5|TWO_SIDED|95.0|-0.11|0.23|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.23|-0.11|0.500
73907547|NCT02038452|147344999|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.21|TWO_SIDED|95.0|-0.07|0.33|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms||The main treatment analyses were based on intention to treat approach||0.33|-0.07|0.21
73907548|NCT02038452|147345000|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.96|TWO_SIDED|95.0|-0.175|0.166|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.166|-0.175|0.96
73907549|NCT02038452|147345001|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.055|TWO_SIDED|95.0|-0.02|1.59|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||1.59|-0.02|0.055
73907550|NCT02038452|147345002|SUPERIORITY||Odds Ratio (OR)|1.12||||0.76|TWO_SIDED|95.0|0.55|2.2|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||2.20|0.55|0.76
73907551|NCT02038452|147345003|SUPERIORITY||Odds Ratio (OR)|1.66||||0.23|TWO_SIDED|95.0|0.73|3.77|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.77|0.73|0.23
73907552|NCT02038452|147345004|SUPERIORITY||Odds Ratio (OR)|1.28||||0.66|TWO_SIDED|95.0|0.41|3.98|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.98|0.41|0.66
73907553|NCT02038452|147345005|SUPERIORITY||Odds Ratio (OR)|1.43||||0.66|TWO_SIDED|95.0|0.28|7.34|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||7.34|0.28|0.66
73907554|NCT02038452|147345006|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4|TWO_SIDED|95.0|0.63|3.18|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.18|0.63|0.40
73964084|NCT00567489|147464197|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
74025832|NCT00955110|147604397|SUPERIORITY_OR_OTHER||Least Square Mean Difference|5.5||||0.395|TWO_SIDED|95.0|-7.3|18.3||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||18.3|-7.3|0.395
74025833|NCT00955110|147604397|SUPERIORITY_OR_OTHER||Least Square Mean Difference|38.0|||<|0.001|TWO_SIDED|95.0|25.2|50.8||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||50.8|25.2|<0.001
74025834|NCT00955110|147604397|SUPERIORITY_OR_OTHER||Least Square Mean Difference|56.0|||<|0.001|TWO_SIDED|95.0|43.1|68.9||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||68.9|43.1|<0.001
74025835|NCT00955110|147604397|SUPERIORITY_OR_OTHER||Least Square Mean Difference|66.8|||<|0.001|TWO_SIDED|95.0|53.9|79.7||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||79.7|53.9|<0.001
74025836|NCT04902885|147604410|SUPERIORITY|||||||0.0003|||||||non-parametric ANCOVA|||70 subjects (35 per group) provided approximately 95% power at the test level of α = 0.05 (2-sided) .Assuming a dropout rate of approximately 12%, the sample size for Part II was 80 subjects (40 per group)||||0.0003
74025837|NCT00756002|147604428|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.||||<0.001
73907555|NCT02038452|147345007|SUPERIORITY||Odds Ratio (OR)|1.99||||0.2|TWO_SIDED|95.0|0.7|5.66|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||5.66|0.70|0.20
73907556|NCT02038452|147345008|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.001|TWO_SIDED|95.0|-0.53|-0.14||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||-0.14|-0.53|0.001
73907557|NCT02038452|147345009|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.74|TWO_SIDED|95.0|-0.17|0.24||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.24|-0.17|0.74
73907558|NCT02038452|147345010|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.41|TWO_SIDED|95.0|-0.3|0.12||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.12|-0.30|0.41
73907559|NCT02038452|147345011|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.58|TWO_SIDED|95.0|-0.16|0.28||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.28|-0.16|0.58
73907560|NCT02038452|147345012|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.009|TWO_SIDED|95.0|-1.72|-0.24||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||-0.24|-1.72|0.009
73907561|NCT02038452|147345013|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.058|TWO_SIDED|95.0|-0.02|1.54||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||1.54|-0.02|0.058
73907562|NCT02038452|147345014|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.95|TWO_SIDED|95.0|-0.79|0.85||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.85|-0.79|0.95
73907563|NCT02038452|147345015|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.35|TWO_SIDED|95.0|-0.45|1.26||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||1.26|-0.45|0.35
73907564|NCT02038452|147345016|SUPERIORITY||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.19|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.19|-0.54|<0.001
73907565|NCT02038452|147345017|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.59|-0.21|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.21|-0.59|<0.001
73907566|NCT02038452|147345018|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.005|TWO_SIDED|95.0|-0.44|-0.08|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.08|-0.44|0.005
73907567|NCT02038452|147345019|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.002|TWO_SIDED|95.0|-1.72|-0.38|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.38|-1.72|0.002
74025838|NCT00756002|147604429|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
73907568|NCT02038452|147345020|SUPERIORITY||Odds Ratio (OR)|0.35||||0.006|TWO_SIDED|95.0|0.17|0.74|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.74|0.17|0.006
73907569|NCT02038452|147345021|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.58|TWO_SIDED|95.0|-0.13|0.24|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.24|-0.13|0.58
73907570|NCT02038452|147345022|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.25|TWO_SIDED|95.0|-0.09|0.35|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.35|-0.09|0.25
73907571|NCT02038452|147345023|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.93|TWO_SIDED|95.0|-0.17|0.18|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.18|-0.17|0.93
73907572|NCT02038452|147345024|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.052|TWO_SIDED|95.0|-0.01|1.61|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||1.61|-0.01|0.052
73907573|NCT02038452|147345025|SUPERIORITY||Odds Ratio (OR)|1.29||||0.53|TWO_SIDED|95.0|0.58|2.88|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||2.88|0.58|0.53
73907574|NCT02038452|147345026|SUPERIORITY||Odds Ratio (OR)|1.43||||0.41|TWO_SIDED|95.0|0.61|3.34|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.34|0.61|0.41
73907575|NCT02038452|147345028|SUPERIORITY||Odds Ratio (OR)|1.32||||0.52|TWO_SIDED|95.0|0.57|3.06|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.06|0.57|0.52
74025839|NCT00756002|147604430|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025840|NCT00756002|147604431|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.||||0.003
74025841|NCT00756002|147604432|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025842|NCT00756002|147604433|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025843|NCT00756002|147604434|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025844|NCT00756002|147604435|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
73907576|NCT02038452|147345029|SUPERIORITY||Odds Ratio (OR)|2.05||||0.18|TWO_SIDED|95.0|0.72|5.78|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||5.78|0.72|0.18
73907577|NCT02038452|147345030|SUPERIORITY||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.55|-0.18|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.18|-0.55|<0.001
73907578|NCT02038452|147345031|SUPERIORITY||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.19|-0.59|<0.001
73907579|NCT02038452|147345032|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.003|TWO_SIDED|95.0|-0.46|-0.09|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.09|-0.46|0.003
73907580|NCT02038452|147345033|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.001|TWO_SIDED|95.0|-1.85|-0.48|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.48|-1.85|0.001
73964085|NCT00567489|147464197|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
73964086|NCT00567489|147464197|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
73964087|NCT00567489|147464197|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
73964088|NCT00567489|147464197|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
73907581|NCT02038452|147345034|SUPERIORITY||Odds Ratio (OR)|0.34||||0.007|TWO_SIDED|95.0|0.16|0.74|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.74|0.16|0.007
73907582|NCT02038452|147345035|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.63|TWO_SIDED|95.0|-0.15|0.25|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.25|-0.15|0.63
73907583|NCT02038452|147345036|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.28|TWO_SIDED|95.0|-0.1|0.35|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.35|-0.10|0.28
73907584|NCT02038452|147345037|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9|TWO_SIDED|95.0|-0.18|0.2|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.20|-0.18|0.900
73907585|NCT02038452|147345038|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.09|TWO_SIDED|95.0|-0.11|1.59|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||1.59|-0.11|0.09
73907586|NCT02038452|147345039|SUPERIORITY||Odds Ratio (OR)|1.26||||0.58|TWO_SIDED|95.0|0.56|2.85|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||2.85|0.56|0.58
73907587|NCT02038452|147345040|SUPERIORITY||Odds Ratio (OR)|1.31||||0.52|TWO_SIDED|95.0|0.57|3.01|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.01|0.57|0.52
73907588|NCT02038452|147345042|SUPERIORITY||Odds Ratio (OR)|1.25||||0.61|TWO_SIDED|95.0|0.53|2.95|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||2.95|0.53|0.61
73907589|NCT02038452|147345043|SUPERIORITY||Odds Ratio (OR)|2.24||||0.14|TWO_SIDED|95.0|0.77|6.58|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||6.58|0.77|0.14
73907590|NCT02038452|147345044|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.014|TWO_SIDED|95.0|-0.93|-0.12|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.12|-0.93|0.014
73907591|NCT02038452|147345045|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.53|TWO_SIDED|95.0|-0.5|0.26|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.26|-0.50|0.53
73907592|NCT02038452|147345046|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.015|TWO_SIDED|95.0|-0.44|-0.05|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.05|-0.44|0.015
73907593|NCT02038452|147345047|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.002|TWO_SIDED|95.0|-0.97|-0.23|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.23|-0.97|0.002
73907594|NCT02038452|147345048|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.25|TWO_SIDED|95.0|-0.6|0.16|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.16|-0.60|0.25
73907595|NCT02038452|147345049|SUPERIORITY||Mean Difference (Final Values)|33.54|||||TWO_SIDED|95.0|-94.57|145.59|||Regression, Linear|Comparison of outcome between treatment groups performed on multiply imputed data||||145.59|-94.57|
73907596|NCT02038452|147345050|SUPERIORITY||Mean Difference (Final Values)|47.06|||||TWO_SIDED|95.0|-104.84|187.31|||Regression, Linear|Comparison of outcome between treatment groups on complete data.||||187.31|-104.84|
73907597|NCT02038452|147345051|SUPERIORITY||Mean Difference (Final Values)|113.15|||||TWO_SIDED|95.0|-37.09|279.21|||Regression, Linear|Comparison of outcome between treatment groups||||279.21|-37.09|
73907598|NCT02038452|147345052|SUPERIORITY||Mean Difference (Final Values)|71.1|||||TWO_SIDED|95.0|-120.84|291.24|||Regression, Linear|Comparison of outcome between treatment groups||||291.24|-120.84|
73907599|NCT02038452|147345053|SUPERIORITY||Mean Difference (Final Values)|0.008|||||TWO_SIDED|95.0|-0.01|0.02|||Regression, Linear|||||0.02|-0.01|
73907600|NCT02038452|147345054|SUPERIORITY||Mean Difference (Final Values)|-0.003|||||TWO_SIDED|95.0|-0.034|0.027|||Regression, Linear|||||0.027|-0.034|
73907601|NCT02038452|147345055|SUPERIORITY||Mean Difference (Final Values)|-0.022|||||TWO_SIDED|95.0|-0.093|0.045|||Regression, Linear|||||0.045|-0.093|
73907602|NCT02080637|147345100|OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|0.5||0.01|TWO_SIDED||||||Paired t-test|||Baseline versus 2 hours post-ambrisentan||||0.01
73907603|NCT02080637|147345101|OTHER||Slope|-27.0||||0.94|TWO_SIDED|95.0|-775.0|723.0|||Regression, Linear|||||723|-775|0.94
73964089|NCT00567489|147464197|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
73907604|NCT02080637|147345102|OTHER||Slope|1.2||||0.61|TWO_SIDED|95.0|-3.9|6.3|||Regression, Linear|||||6.3|-3.9|0.61
73907605|NCT02520661|147345118|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.62|1.22||||||treatment relevant change in number of ED visits by 14 days||1.22|0.62|
73907606|NCT02520661|147345118|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.72|1.3||||||treatment relevant change in number of ED visits by 30 days||1.30|0.72|
73907607|NCT02053051|147345171|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
73907608|NCT01920555|147345174|SUPERIORITY||Mean Difference (Final Values)|-3.18||||0.14|TWO_SIDED|95.0|-5.93|-0.43||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.43|-5.93|0.14
73930936|NCT00280566|147391710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.75||0.0023|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0023
73856614|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.35||||0.729|TWO_SIDED|95.0|-10.91|15.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.61|-10.91|0.729
73856615|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|11.33||||0.087|TWO_SIDED|95.0|-1.55|24.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.21|-1.55|0.087
73856616|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|75.6|||<|0.001|TWO_SIDED|95.0|62.5|88.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.70|62.50|<0.001
73856617|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.45|||<|0.001|TWO_SIDED|95.0|53.65|81.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.24|53.65|<0.001
73856618|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.46|||<|0.001|TWO_SIDED|95.0|61.21|87.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||87.70|61.21|<0.001
73856619|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.23|||<|0.001|TWO_SIDED|95.0|50.3|78.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.17|50.30|<0.001
73856620|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|11.59||||0.052|TWO_SIDED|95.0|0.12|23.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.06|0.12|0.052
73856621|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.84||||0.652|TWO_SIDED|95.0|-9.49|15.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.16|-9.49|0.652
73856622|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.28||||0.09|TWO_SIDED|95.0|-1.47|22.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.03|-1.47|0.090
73856623|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|79.93|||<|0.001|TWO_SIDED|95.0|67.41|92.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||92.46|67.41|<0.001
73856624|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.65|||<|0.001|TWO_SIDED|95.0|58.25|85.05||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.05|58.25|<0.001
73856625|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|78.92|||<|0.001|TWO_SIDED|95.0|66.29|91.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||91.56|66.29|<0.001
73856626|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.56|||<|0.001|TWO_SIDED|95.0|57.04|84.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.07|57.04|<0.001
73856627|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.61||||0.069|TWO_SIDED|95.0|-0.59|19.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.80|-0.59|0.069
74085129|NCT00407745|147723834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.387||0.361|TWO_SIDED|95.0|-1.12|0.41||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 11 - Pins and needles~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.41|-1.12|0.3610
73907609|NCT01920555|147345174|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.79|TWO_SIDED|95.0|-3.75|1.49||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.49|-3.75|0.79
73856628|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.65||||0.911|TWO_SIDED|95.0|-10.73|12.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.03|-10.73|0.911
73856629|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.27||||0.127|TWO_SIDED|95.0|-2.23|18.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.77|-2.23|0.127
73856630|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.55|||<|0.001|TWO_SIDED|95.0|62.37|90.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.72|62.37|<0.001
73856631|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.6|||<|0.001|TWO_SIDED|95.0|55.93|85.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.28|55.93|<0.001
73964090|NCT00567489|147464197|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
73964091|NCT00567489|147464197|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
73964092|NCT00567489|147464197|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
73964093|NCT00567489|147464198|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
73964094|NCT00567489|147464198|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
73964095|NCT00567489|147464198|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
73964096|NCT00567489|147464198|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
73964097|NCT00567489|147464198|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
73964098|NCT00567489|147464198|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
73964099|NCT00567489|147464199|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
73964100|NCT00567489|147464199|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
73964101|NCT00567489|147464199|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
73964102|NCT00567489|147464199|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
73964103|NCT00567489|147464200|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
73964104|NCT00567489|147464200|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
73964105|NCT00567489|147464201|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
73964106|NCT00567489|147464202|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
73964107|NCT00567489|147464202|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
73856632|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.5|||<|0.001|TWO_SIDED|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.79|62.22|<0.001
73856633|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.05|||<|0.001|TWO_SIDED|95.0|53.02|83.09||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.09|53.02|<0.001
73856634|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.57||||0.098|TWO_SIDED|95.0|-1.47|18.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.61|-1.47|0.098
73856635|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.01||||0.721|TWO_SIDED|95.0|-9.02|13.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.04|-9.02|0.721
73856636|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.28||||0.115|TWO_SIDED|95.0|-1.85|18.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.41|-1.85|0.115
73856637|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|77.66|||<|0.001|TWO_SIDED|95.0|63.63|91.69||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||91.69|63.63|<0.001
73856638|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.65|||<|0.001|TWO_SIDED|95.0|57.07|86.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.22|57.07|<0.001
73856639|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.5|||<|0.001|TWO_SIDED|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.79|62.22|<0.001
73856640|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.1|||<|0.001|TWO_SIDED|95.0|54.14|84.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.06|54.14|<0.001
73856641|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.56||||0.086|TWO_SIDED|95.0|-1.15|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.27|-1.15|0.086
73856642|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.01||||0.714|TWO_SIDED|95.0|-8.76|12.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.77|-8.76|0.714
73856643|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|7.21||||0.164|TWO_SIDED|95.0|-2.8|17.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.22|-2.80|0.164
73856644|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
73856645|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.5|||<|0.001|TWO_SIDED|95.0|54.29|84.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.70|54.29|<0.001
73964108|NCT00567489|147464202|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
74025845|NCT00756002|147604436|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025846|NCT00756002|147604437|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025847|NCT00756002|147604438|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025848|NCT00756002|147604439|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025849|NCT00756002|147604440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||LS means from ANCOVA model with effects for treatment \& pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|||||||<0.001
74025850|NCT00756002|147604441|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||LS means from ANCOVA model with effects for treatment \& pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|||||||0.043
74025851|NCT00756002|147604442|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.005
74025852|NCT00756002|147604443|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.010
74025853|NCT00756002|147604444|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.002
74085130|NCT00407745|147723834|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.402||0.4915|TWO_SIDED|95.0|-1.07|0.52||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 12 - Tingling~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.52|-1.07|0.4915
73856646|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
73856647|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.0|||<|0.001|TWO_SIDED|95.0|51.4|82.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||82.61|51.40|<0.001
73856648|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|7.46||||0.129|TWO_SIDED|95.0|-2.12|17.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.04|-2.12|0.129
73856649|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.97||||0.712|TWO_SIDED|95.0|-8.5|12.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.43|-8.50|0.712
73856650|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.12||||0.229|TWO_SIDED|95.0|-3.76|16.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.00|-3.76|0.229
73856651|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
73856652|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.54|||<|0.001|TWO_SIDED|95.0|55.45|85.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.64|55.45|<0.001
74025854|NCT00756002|147604445|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.006
74025855|NCT00756002|147604446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
74085131|NCT00407745|147723835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0536||95.0||||p-values are adjusted for baseline score. Significance was declared if p-value \<=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.||||0.0536
73856653|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
73856654|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.05|||<|0.001|TWO_SIDED|95.0|52.53|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.57|52.53|<0.001
73856655|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.38||||0.186|TWO_SIDED|95.0|-3.05|15.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.81|-3.05|0.186
73856656|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.97||||0.703|TWO_SIDED|95.0|-8.18|12.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.12|-8.18|0.703
73856657|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.06||||0.312|TWO_SIDED|95.0|-4.68|14.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.79|-4.68|0.312
73856658|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
73856659|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.59|||<|0.001|TWO_SIDED|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.57|56.61|<0.001
73856660|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
73856661|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.21|||<|0.001|TWO_SIDED|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.56|53.86|<0.001
73856662|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856663|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73930937|NCT00280566|147391710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.91||0.1412|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate||||0.1412
73907610|NCT01920555|147345174|SUPERIORITY||Mean Difference (Final Values)|-4.79|||<|0.01|TWO_SIDED|95.0|-7.35|-2.24||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-2.24|-7.35|<0.01
73907611|NCT01920555|147345174|SUPERIORITY||Mean Difference (Final Values)|-3.76||||0.04|TWO_SIDED|95.0|-6.37|-1.15|||Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-1.15|-6.37|0.04
73907612|NCT01920555|147345174|SUPERIORITY||Mean Difference (Final Values)|-2.04||||0.72|TWO_SIDED|95.0|-5.04|0.95||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.95|-5.04|0.72
73907613|NCT01920555|147345174|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.8|TWO_SIDED|95.0|-3.18|2.46||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.46|-3.18|0.80
73907614|NCT01920555|147345174|SUPERIORITY||Mean Difference (Final Values)|-3.12||||0.14|TWO_SIDED|95.0|-5.97|-0.44||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.44|-5.97|0.14
73907615|NCT01920555|147345174|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.72|TWO_SIDED|95.0|-4.65|0.96||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.96|-4.65|0.72
73907616|NCT01920555|147345175|SUPERIORITY||Mean Difference (Final Values)|-5.15||||0.33|TWO_SIDED|95.0|-12.44|2.14||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.14|-12.44|0.33
73907617|NCT01920555|147345175|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.53|TWO_SIDED|95.0|-9.03|4.72||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||4.72|-9.03|0.53
73907618|NCT01920555|147345175|SUPERIORITY||Mean Difference (Final Values)|-9.85||||0.02|TWO_SIDED|95.0|-16.56|-3.15||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-3.15|-16.56|0.02
73930938|NCT00280566|147391710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.87||0.0861|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0861
74085132|NCT00407745|147723836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3107||95.0||||p-values are adjusted for baseline score. Significance was declared if p-value \<=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.||||0.3107
74085133|NCT00407745|147723837|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.89|STANDARD_ERROR_OF_MEAN|2.182||0.0262|TWO_SIDED|95.0|-9.19|-0.59||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS 9-item Sleep Problems Index as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.59|-9.19|0.0262
74085134|NCT00407745|147723838|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.67|STANDARD_ERROR_OF_MEAN|2.985||0.0041|TWO_SIDED|95.0|-14.55|-2.78||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep disturbance as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-2.78|-14.55|0.0041
74025856|NCT00756002|147604447|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
74025857|NCT00756002|147604448|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
74085135|NCT00407745|147723839|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.78|STANDARD_ERROR_OF_MEAN|3.492||0.0998|TWO_SIDED|95.0|-1.11|12.66||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Adequacy as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||12.66|-1.11|0.0998
73856664|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856665|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
73856666|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.59|||<|0.001|TWO_SIDED|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.57|56.61|<0.001
73856667|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
73856668|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.21|||<|0.001|TWO_SIDED|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.56|53.86|<0.001
73856669|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856670|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856671|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856672|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
74025858|NCT00756002|147604449|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025859|NCT00756002|147604450|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025860|NCT00756002|147604451|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025861|NCT00756002|147604452|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025862|NCT00756002|147604453|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025863|NCT00756002|147604454|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
74025864|NCT00756002|147604455|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.785
74025865|NCT00756002|147604456|SUPERIORITY_OR_OTHER|||||||0.422||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.422
74025866|NCT00756002|147604457|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.665
74025867|NCT00756002|147604458|SUPERIORITY_OR_OTHER|||||||0.228||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.228
73856673|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73856674|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73856675|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73856676|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856677|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856678|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856679|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73907619|NCT01920555|147345175|SUPERIORITY||Mean Difference (Final Values)|-7.72||||0.08|TWO_SIDED|95.0|-14.52|-0.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.93|-14.52|0.08
73907620|NCT01920555|147345176|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.08|TWO_SIDED|95.0|-1.83|-0.22|||Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.22|-1.83|0.08
73907621|NCT01920555|147345176|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.82|TWO_SIDED|95.0|-1.02|0.51||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.51|-1.02|0.82
73907622|NCT01920555|147345176|SUPERIORITY||Mean Difference (Final Values)|-1.28||||0.0072|TWO_SIDED|95.0|-2.02|-0.54||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.54|-2.02|0.00720
73907623|NCT01920555|147345176|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.04884|TWO_SIDED|95.0|-1.81|-0.29||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.29|-1.81|0.04884
73907624|NCT01920555|147345176|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.48|TWO_SIDED|95.0|-1.7|0.28||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.28|-1.70|0.48
74085136|NCT00407745|147723840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.7|STANDARD_ERROR_OF_MEAN|3.501||0.1048|TWO_SIDED|95.0|-1.2|12.61||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Snoring as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||12.61|-1.20|0.1048
74085137|NCT00407745|147723841|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.14|STANDARD_ERROR_OF_MEAN|2.417||0.0347|TWO_SIDED|95.0|-9.91|-0.37||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included baseline MOS - Awaken Short of Breath or with headache as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.37|-9.91|0.0347
73964109|NCT00567489|147464202|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
73964110|NCT00567489|147464203|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
73964111|NCT00567489|147464203|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
73964112|NCT00567489|147464203|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
73964113|NCT00567489|147464203|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
73964114|NCT00567489|147464204|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
73964115|NCT00567489|147464204|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
73964116|NCT00567489|147464205|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
73964117|NCT00567489|147464205|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
73907625|NCT01920555|147345176|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.82|TWO_SIDED|95.0|-1.32|0.55||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.55|-1.32|0.82
73907626|NCT01920555|147345176|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.16|TWO_SIDED|95.0|-1.91|-0.09||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.09|-1.91|0.16
73907627|NCT01920555|147345176|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.27|TWO_SIDED|95.0|-1.78|0.07||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.07|-1.78|0.27
73930939|NCT00280566|147391710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.82||0.5992|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5992
74085138|NCT00407745|147723842|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.189||0.0436|TWO_SIDED|95.0|0.01|0.76||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Quantity as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.76|0.01|0.0436
73856680|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73856681|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73856682|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73856683|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856684|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856685|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856686|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856687|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73964118|NCT00567489|147464206|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
73964119|NCT00567489|147464206|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
73964120|NCT00567489|147464207|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
73964121|NCT00567489|147464208|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
73964122|NCT00567489|147464208|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
73964123|NCT00567489|147464208|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
73964124|NCT00567489|147464208|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
73964125|NCT00567489|147464209|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
73964126|NCT00567489|147464209|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
73964127|NCT00567489|147464210|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
73964128|NCT00567489|147464210|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
73964129|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
73964130|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
73964131|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
73964132|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
73964133|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
73964134|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
73964135|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
73964136|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
73964137|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
73964138|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
73964139|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
73964140|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
73964141|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
73964142|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
73964143|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
73964144|NCT00567489|147464211|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
73964145|NCT00567489|147464212|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
73964146|NCT00567489|147464212|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
73964147|NCT00567489|147464213|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
73964148|NCT00567489|147464213|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
74025868|NCT00756002|147604459|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.099
73907628|NCT01920555|147345177|SUPERIORITY||Mean Difference (Net)|-0.54||||0.54|TWO_SIDED|95.0|-1.25|0.17||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.17|-1.25|0.54
73907629|NCT01920555|147345177|SUPERIORITY||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.78|0.58||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.58|-0.78|1.00
73907630|NCT01920555|147345177|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.03|TWO_SIDED|95.0|-1.64|-0.31||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.31|-1.64|0.03
73907631|NCT01920555|147345177|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.54|TWO_SIDED|95.0|-1.24|0.11||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.11|-1.24|0.54
73907632|NCT01920555|147345177|SUPERIORITY||Mean Difference (Final Values)|-0.19||||1|TWO_SIDED|95.0|-0.96|0.57||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.57|-0.96|1.00
73907633|NCT01920555|147345177|SUPERIORITY||Mean Difference (Final Values)|-0.21||||1|TWO_SIDED|95.0|-0.93|0.51||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.51|-0.93|1.00
73907634|NCT01920555|147345177|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.52|TWO_SIDED|95.0|-1.35|0.06||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.06|-1.35|0.52
73907635|NCT01920555|147345177|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.54|TWO_SIDED|95.0|-1.33|0.1||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.10|-1.33|0.54
73930940|NCT00280566|147391710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.76||0.5873|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5873
74025869|NCT00756002|147604460|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.005
74025870|NCT00756002|147604461|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.004
73907636|NCT01920555|147345178|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.74|TWO_SIDED|95.0|-0.79|0.08||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.08|-0.79|0.74
73907637|NCT01920555|147345178|SUPERIORITY||Mean Difference (Final Values)|0.04||||1|TWO_SIDED|95.0|-0.37|0.45||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.45|-0.37|1.00
73907638|NCT01920555|147345178|SUPERIORITY||Mean Difference (Final Values)|-0.61||||0.02|TWO_SIDED|95.0|-1.01|-0.21||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.21|-1.01|0.02
73907639|NCT01920555|147345178|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.8|TWO_SIDED|95.0|-0.72|0.1||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.10|-0.72|0.80
73907640|NCT01920555|147345178|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.88|TWO_SIDED|95.0|-0.83|0.18||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.18|-0.83|0.88
73907641|NCT01920555|147345178|SUPERIORITY||Mean Difference (Final Values)|-0.05||||1|TWO_SIDED|95.0|-0.53|0.44||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.44|-0.53|1.00
73907642|NCT01920555|147345178|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.88|TWO_SIDED|95.0|-0.79|0.15||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.15|-0.79|0.88
73964149|NCT00567489|147464214|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
73964150|NCT00567489|147464214|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
73964151|NCT00567489|147464215|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
73964152|NCT03631550|147464218|SUPERIORITY|||||||0.018|||||||Chi-squared|||||||0.018
73964153|NCT03631550|147464219|SUPERIORITY|||||||0.0466|||||||Chi-squared|||||||0.0466
73964154|NCT03631550|147464220|SUPERIORITY|||||||0.0677|||||||Chi-squared|||||||0.0677
73964155|NCT03631550|147464221|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
73964156|NCT03631550|147464222|OTHER|||||||0.0968|||||||Fisher Exact|||||||0.0968
73964157|NCT03631550|147464223|SUPERIORITY|||||||0.0121|||||||ANCOVA|||||||0.0121
73964158|NCT00879060|147464254|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable PINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||1.0
73964159|NCT00879060|147464254|OTHER||Mean Difference (Final Values)|0.2||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable PIIINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||0.8
73964160|NCT00879060|147464254|OTHER||Mean Difference (Final Values)|0.3||||0.3|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.aseline.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable ICTP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||0.3
73907643|NCT01920555|147345178|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.88|TWO_SIDED|95.0|-0.76|0.19||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.19|-0.76|0.88
73907644|NCT01920555|147345179|SUPERIORITY||Mean Difference (Final Values)|11.18||||0.49|TWO_SIDED|95.0|-0.94|23.29||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||23.29|-0.94|0.49
73907645|NCT01920555|147345179|SUPERIORITY||Mean Difference (Final Values)|1.37||||1|TWO_SIDED|95.0|-10.19|12.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||12.93|-10.19|1.00
73907646|NCT01920555|147345179|SUPERIORITY||Mean Difference (Final Values)|16.54||||0.03|TWO_SIDED|95.0|5.31|27.77||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||27.77|5.31|0.03
73907647|NCT01920555|147345179|SUPERIORITY||Mean Difference (Final Values)|8.68||||0.82|TWO_SIDED|95.0|-2.81|20.16||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||20.16|-2.81|0.82
73907648|NCT01920555|147345179|SUPERIORITY||Mean Difference (Final Values)|5.11||||1|TWO_SIDED|95.0|-8.83|19.05||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||19.05|-8.83|1.00
73907649|NCT01920555|147345179|SUPERIORITY||Mean Difference (Final Values)|-6.64||||1|TWO_SIDED|95.0|-19.87|6.59||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||6.59|-19.87|1.00
73907650|NCT01920555|147345179|SUPERIORITY||Mean Difference (Final Values)|7.64||||1|TWO_SIDED|95.0|-5.26|20.53||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||20.53|-5.26|1.00
73907651|NCT01920555|147345179|SUPERIORITY||Mean Difference (Final Values)|4.8||||1|TWO_SIDED|95.0|-8.31|17.91||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||17.91|-8.31|1.00
73907652|NCT01920555|147345180|SUPERIORITY||Mean Difference (Final Values)|-1.21||||1|TWO_SIDED|95.0|-3.99|1.56||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.56|-3.99|1.00
73907653|NCT01920555|147345180|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.17|TWO_SIDED|95.0|-1.9|3.43||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||3.43|-1.90|0.17
73907654|NCT01920555|147345180|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.3|TWO_SIDED|95.0|-5.32|-0.16||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.16|-5.32|0.30
73907655|NCT01920555|147345180|SUPERIORITY||Mean Difference (Final Values)|-0.71||||1|TWO_SIDED|95.0|-3.35|1.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.93|-3.35|1.00
73907656|NCT01920555|147345180|SUPERIORITY||Mean Difference (Final Values)|-0.29||||1|TWO_SIDED|95.0|-3.25|2.66||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.66|-3.25|1.00
73907657|NCT01920555|147345180|SUPERIORITY||Mean Difference (Final Values)|2.76||||0.39|TWO_SIDED|95.0|-0.06|5.59||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||5.59|-0.06|0.39
73907658|NCT01920555|147345180|SUPERIORITY||Mean Difference (Final Values)|-1.17||||1|TWO_SIDED|95.0|-3.91|1.58||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.58|-3.91|1.00
73907659|NCT01920555|147345180|SUPERIORITY||Mean Difference (Final Values)|-0.43||||1|TWO_SIDED|95.0|-3.22|2.35||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.35|-3.22|1.00
73907660|NCT01886716|147345194|SUPERIORITY_OR_OTHER||Slope|-0.8|STANDARD_ERROR_OF_MEAN|0.95|=|0.4|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .71|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training."||||=.40
73907661|NCT01886716|147345194|SUPERIORITY_OR_OTHER||Slope|0.27|STANDARD_ERROR_OF_MEAN|0.95|=|0.78|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .08|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training."||||=.78
74025871|NCT00756002|147604462|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.001
74025872|NCT00756002|147604463|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.004
74085139|NCT00407745|147723843|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.02|STANDARD_ERROR_OF_MEAN|2.77||0.2761|TWO_SIDED|95.0|-2.44|8.49||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Somnolence as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||8.49|-2.44|0.2761
73907662|NCT01886716|147345195|SUPERIORITY_OR_OTHER||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.07|=|0.67|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .18|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training"||||=.67
73907663|NCT01886716|147345195|SUPERIORITY_OR_OTHER||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.07|=|0.32|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = 1.01|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training"||||=.32
73907664|NCT00785928|147345198|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||This is p-value for the fitted ACR50 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose\^2) from the likelihood ratio test.|Linear-quadratic regression model|||||||0.059
73964161|NCT00879060|147464254|OTHER||Absolute difference|0.0||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable PINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups.||||1.0
73964162|NCT00879060|147464255|OTHER||Absolute difference|1.2||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable peak oxygen consumption with exercise (peak VO2) between spironolactone treated and placebo groups.||||0.7
74025873|NCT00756002|147604464|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.040
74025874|NCT00756002|147604465|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.814
74025875|NCT00756002|147604466|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.929
74025876|NCT00756002|147604467|SUPERIORITY_OR_OTHER|||||||0.591||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.591
73907665|NCT00785928|147345198|SUPERIORITY_OR_OTHER||ED95|119.0||||0.042||95.0||||This is the p-value for the estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is ED95 in mg.||||||0.042
73907666|NCT00785928|147345199|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||This is the p-value for the fitted ACR20 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose\^2) from the likelihood ratio test.|Linear-quadratic regression model|||||||0.044
73907667|NCT00785928|147345199|SUPERIORITY_OR_OTHER||ED95|118.5||||0.005||95.0||||This p-value is for estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) of the ACR20 and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is the ED95 in mg.||||||0.005
73907668|NCT00785928|147345200|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.623
73907669|NCT00785928|147345200|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.160
73964163|NCT00879060|147464256|OTHER||Absolute difference|0.0||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable New York Heart Association (NYHA) Functional Class between spironolactone treated and placebo groups.||||0.8
74025877|NCT00756002|147604468|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.015
73907670|NCT00785928|147345200|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.568
73907671|NCT00785928|147345200|SUPERIORITY_OR_OTHER|||||||0.633||95.0||||Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.633
73907672|NCT00785928|147345200|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.754
73907673|NCT00785928|147345200|SUPERIORITY_OR_OTHER|||||||0.289||95.0||||Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.289
73907674|NCT00785928|147345201|SUPERIORITY_OR_OTHER|||||||0.671||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.671
73907675|NCT00785928|147345201|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.696
73907676|NCT00785928|147345201|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.367
73907677|NCT00785928|147345201|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.645
73907678|NCT00785928|147345201|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.944
73907679|NCT00785928|147345201|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.133
73907680|NCT00785928|147345202|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||Pairwise comparison (1-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.457
73964164|NCT00879060|147464257|OTHER||Absolute difference|1.4||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable Septal E/e' between spironolactone treated and placebo groups.||||1.0
73964165|NCT00879060|147464258|OTHER||Absolute difference|0.2||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable percentage of left ventricular mass (%LV) between spironolactone treated and placebo groups.||||0.7
73964166|NCT00879060|147464259|OTHER||Absolute difference|0.9||||0.4|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable maximum left ventricular wall thickness (Max LV) between spironolactone treated and placebo groups.||||0.4
73964167|NCT00879060|147464260|OTHER||Absolute difference|5.7||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable left ventricular end-diastolic (LVED) cavity size between spironolactone treated and placebo groups.||||0.7
73964168|NCT00879060|147464261|OTHER||Absolute difference|0.1||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable left atrial dimension between spironolactone treated and placebo groups.||||0.8
73964169|NCT01976312|147464270|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73964170|NCT03010631|147464277|SUPERIORITY||Ratio of Geometric LS Means|1.441|||||TWO_SIDED|90.0|1.166|1.782||||||||1.782|1.166|
73907681|NCT00785928|147345202|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Pairwise comparison (1-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.874
73907682|NCT00785928|147345202|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||Pairwise comparison (1-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.278
73907683|NCT00785928|147345202|SUPERIORITY_OR_OTHER|||||||0.357||95.0||||Pairwise comparison (1-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.357
73907684|NCT00785928|147345202|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||Pairwise comparison (1-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.271
73907685|NCT00785928|147345202|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||Pairwise comparison (1-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.048
73907686|NCT00785928|147345203|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||This p-value is from 2-sided comparison of 1 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||0.875
73964171|NCT03010631|147464278|SUPERIORITY||Ratio of Geometric LS Means|2.045|||||TWO_SIDED|90.0|1.615|2.589||||||||2.589|1.615|
73964172|NCT03010631|147464279|OTHER||Ratio of Geometric LS Means|0.888|||||TWO_SIDED|90.0|0.675|1.168||||||||1.168|0.675|
73964173|NCT03010631|147464280|OTHER||Ratio of Geometric LS Means|0.413|||||TWO_SIDED|90.0|0.339|0.502||||||||0.502|0.339|
73907687|NCT00785928|147345203|SUPERIORITY_OR_OTHER|||||||1||95.0||||This p-value is from 2-sided comparison of 3 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||1.000
73907688|NCT00785928|147345203|SUPERIORITY_OR_OTHER|||||||1||95.0||||This p-value is from 2-sided comparison of 10 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||1.000
73907689|NCT00785928|147345203|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||This p-value is from a 2-sided comparison of 30 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.304
73907690|NCT00785928|147345203|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||This p-value is from a 2-sided comparison of 60 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.489
73907691|NCT00785928|147345203|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||This p-value is from a 2-sided comparison of 120 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.091
73907692|NCT00785928|147345204|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.746
73907693|NCT00785928|147345204|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.393
73964174|NCT01996605|147464288|SUPERIORITY||||||<|0.05||||||T|ANOVA|A one-way ANOVA was performed on the single primary outcome datapoint comparing the three groups.||The null hypothesis was that there would be no difference in area of hyperalgesia 105 minutes after study drug injection among the three groups.||||<0.05
73964175|NCT02769858|147464314|OTHER|||||||0.001|||||||t-test, 2 sided|||||||.001
73964176|NCT02769858|147464315|OTHER|||||||0.019|||||||t-test, 2 sided|||||||.019
73964177|NCT02769858|147464316|OTHER|||||||0.502|||||||t-test, 2 sided|||||||.502
73964178|NCT03088813|147464332|OTHER||Hazard Ratio (HR)|1.11||||0.3094|TWO_SIDED|95.0|0.9|1.37|||Stratified log-rank test|From stratified log-rank test, stratified by corrected region and corrected platinum sensitivity.|The associated HR and two-sided 95% Confidence Interval (CI) were estimated using stratified Cox proportional hazards model, stratified by corrected region and corrected platinum sensitivity.|||1.37|0.90|0.3094
73964179|NCT03088813|147464336|OTHER||Hazard Ratio (HR)|0.96||||0.7053|TWO_SIDED|95.0|0.77|1.2||From stratified log-rank test, stratified by corrected region and corrected platinum sensitivity|Stratified log-rank test||The associated HR and two-sided 95% CI were estimated using stratified Cox proportional hazards model, stratified by corrected region and corrected platinum sensitivity.|||1.20|0.77|0.7053
73907694|NCT00785928|147345204|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.549
73907695|NCT00785928|147345204|SUPERIORITY_OR_OTHER|||||||0.619||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.619
73907696|NCT00785928|147345204|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.893
73907697|NCT00785928|147345204|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.066
73907698|NCT00785928|147345205|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.583
73964180|NCT03088813|147464337|OTHER||Difference in ORR|22.29|||<|0.0001|TWO_SIDED|95.0|13.97|30.61||ORR difference, 95% CI and P-value are obtained from the Cochran-Mantel-Haenszel test stratified by corrected region and corrected platinum sensitivity.|Cochran-Mantel-Haenszel|||||30.61|13.97|<0.0001
73964181|NCT01903811|147464342|SUPERIORITY||Hazard Ratio (HR)|1.061||||0.384|TWO_SIDED|80.0|0.821|1.37||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test||||1.370|0.821|0.384
73907699|NCT00785928|147345205|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.311
73907700|NCT00785928|147345205|SUPERIORITY_OR_OTHER|||||||0.752||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.752
73964182|NCT01903811|147464343|SUPERIORITY||Hazard Ratio (HR)|1.149||||0.284|TWO_SIDED|80.0|0.841|1.571||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test||||1.571|0.841|0.284
73964183|NCT01903811|147464344|SUPERIORITY|||||||0.113|||||||Cochran-Mantel-Haenszel|||Compare the rate of confirmed PR or better between treatment arms.||||0.1130
73964184|NCT04928001|147464374|SUPERIORITY||Mean Difference (Final Values)|31.0||||0.01|TWO_SIDED|95.0|0.0|60.0|||t-test, 1 sided|||||60|0|.01
73964185|NCT01693120|147464375|SUPERIORITY||rate|1.6||||0.175|ONE_SIDED|95.0||4.9|||exact binomial test|||The null hypothesis was that the procedure or device related stroke rate within 30-days of a Phased RF ablation procedure was 3.5% or greater. The alternative hypothesis was that this rate was less than 3.5%. A sample size of 300 subjects provided 90% power to test the null hypothesis assuming the true stroke rate was 1.0% with a one-sided type I error rate of 0.05||4.9||0.175
73907701|NCT00785928|147345205|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.737
73907702|NCT00785928|147345205|SUPERIORITY_OR_OTHER|||||||0.522||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.522
73907703|NCT00785928|147345205|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.073
73907704|NCT00785928|147345206|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.969
73907705|NCT00785928|147345206|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.352
73907706|NCT00785928|147345206|SUPERIORITY_OR_OTHER|||||||0.406||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.406
73907707|NCT00785928|147345206|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.266
73907708|NCT00785928|147345206|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.708
73907709|NCT00785928|147345206|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.012
73907710|NCT00785928|147345207|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.880
73907711|NCT00785928|147345207|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.575
73907712|NCT00785928|147345207|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.992
73907713|NCT00785928|147345207|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.646
73964186|NCT01693120|147464376|OTHER|The goal of the analysis was to compute a two-sided 95% confidence interval around the 6-month effectiveness rate. There was no pre-specified hypothesis.|rate|52.6|||||TWO_SIDED|95.0|43.1|62.1||||||||62.1|43.1|
73907714|NCT00785928|147345207|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.054
73907715|NCT00785928|147345207|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.472
73907716|NCT00785928|147345208|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.952
73907717|NCT00785928|147345208|SUPERIORITY_OR_OTHER|||||||0.085||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.085
73907718|NCT00785928|147345208|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.143
73964187|NCT01693120|147464377|OTHER|There was no prespecified hypothesis tested.|rate|90.7|||||TWO_SIDED|95.0|84.3|95.1||||||There was no prespecified hypothesis tested.||95.1|84.3|
73907719|NCT00785928|147345208|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.242
73907720|NCT00785928|147345208|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.317
73907721|NCT00785928|147345208|SUPERIORITY_OR_OTHER|||||||0.456||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.456
73964188|NCT01693120|147464378|OTHER|There was no pre-specified hypothesis to test|rate|0.0|||||TWO_SIDED|95.0|0.0|6.1||||||There was no pre-specified hypothesis to test||6.1|0|
73856688|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73856689|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73856690|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856691|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856692|NCT01559259|147258989|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856693|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|23.99||||0.003|TWO_SIDED|95.0|13.32|34.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||34.67|13.32|0.003
73856694|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.83||||0.048|TWO_SIDED|95.0|4.59|25.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||25.07|4.59|0.048
73856695|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|24.98||||0.005|TWO_SIDED|95.0|13.43|36.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.53|13.43|0.005
73856696|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|16.57||||0.03|TWO_SIDED|95.0|6.25|26.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.88|6.25|0.030
73856697|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.86||||0.269|TWO_SIDED|95.0|-4.8|18.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.53|-4.80|0.269
73907722|NCT00785928|147345209|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.833
73964189|NCT01443845|147464394|SUPERIORITY_OR_OTHER||Rate Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.063||0.1634|TWO_SIDED|95.0|0.81|1.04|||negative binomial regression||p-values are based on a negative binomial regression with factors Treatment and LAMA use.|Rate ratio (Roflumilast/Placebo). A rate ratio \< 1 represents a favorable outcome for the test treatment.||1.04|0.81|0.1634
73856698|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-1.95||||0.735|TWO_SIDED|95.0|-13.34|9.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.43|-13.34|0.735
73856699|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.58||||0.176|TWO_SIDED|95.0|-3.88|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.04|-3.88|0.176
73907723|NCT00785928|147345209|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.826
73964190|NCT01443845|147464394|SUPERIORITY_OR_OTHER||Rate Ratio|0.83|STANDARD_ERROR_OF_MEAN|0.08||0.0195|TWO_SIDED|95.0|0.71|0.97|||negative binomial regression|||Subgroup Analysis - By Sex - Male||0.97|0.71|0.0195
73964191|NCT01443845|147464394|SUPERIORITY_OR_OTHER||Rate Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.101||0.3164|TWO_SIDED|95.0|0.91|1.35|||negative binomial regression|||Subgroup Analysis - By Sex - Female||1.35|0.91|0.3164
73964192|NCT01443845|147464394|SUPERIORITY_OR_OTHER||Rate Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.076||0.0385|TWO_SIDED|95.0|0.74|0.99|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.||0.99|0.74|0.0385
73907724|NCT00785928|147345209|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.091
73907725|NCT00785928|147345209|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.127
73907726|NCT00785928|147345209|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.243
73907727|NCT00785928|147345209|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.037
73907728|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.562||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.562
73964193|NCT01443845|147464394|SUPERIORITY_OR_OTHER||Rate Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.114||0.6475|TWO_SIDED|95.0|0.84|1.32|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.||1.32|0.84|0.6475
73964194|NCT01443845|147464395|SUPERIORITY_OR_OTHER||Rate Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.118||0.6354|TWO_SIDED|95.0|0.75|1.19|||negative binomial regression|||||1.19|0.75|0.6354
73964195|NCT01443845|147464396|SUPERIORITY_OR_OTHER||Rate Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.06||0.0884|TWO_SIDED|95.0|0.8|1.02|||negative binomial regression|||||1.02|0.8|0.0884
73964196|NCT01443845|147464397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0532|STANDARD_ERROR_OF_MEAN|0.0067|<|0.0001|TWO_SIDED|95.0|0.04|0.0664||The MMRM analysis is based on all postbaseline observed data using a mixed model with terms for treatment, baseline, visit, LAMA use, treatment-by-visit and baseline-by-visit interactions.|Mixed Model for Repeated Measures (MMRM)|||||0.0664|0.04|< 0.0001
73964197|NCT03283371|147464408|SUPERIORITY||LS Mean logarithmic difference|-0.16||||0.5053|TWO_SIDED|95.0|-0.62|0.31|||Mixed Model for Repeated Measures (MMRM)|||Analysis is based on MMRM and adjusted for natural log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures), structural etiology category (yes and no), visit, treatment and treatment by visit interaction. An unstructured variance-covariance matrix is used in the model.||0.31|-0.62|0.5053
73907729|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.539||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.539
73907730|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.304
73907731|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.832
73907732|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.010
73907733|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.980
73907734|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.569
73964198|NCT03283371|147464409|SUPERIORITY||Odds Ratio (OR)|2.09||||0.2231|TWO_SIDED|95.0|0.64|6.85|||Regression, Logistic|||Based on logistic regression with a term for treatment group and with adjustment for natural log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures) and structural etiology category (yes and no).||6.85|0.64|0.2231
73964199|NCT03283371|147464412|SUPERIORITY||Odds Ratio (OR)|0.67||||0.6854|TWO_SIDED|95.0|0.1|4.57|||Regression, Logistic|||Based on the logistic regression model with a term for treatment group and with adjustment for log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures) and structural etiology category (yes and no) are considered as covariates.||4.57|0.10|0.6854
73964200|NCT02554786|147464421|SUPERIORITY||Least Square mean (LS Mean)|0.132|STANDARD_ERROR_OF_MEAN|0.0223|<|0.001|TWO_SIDED|95.0|0.088|0.176|||Mixed Model for Repeated Measures (MMRM)|||||0.176|0.088|<0.001
73964201|NCT02554786|147464421|SUPERIORITY||LS Mean|0.211|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.167|0.255|||MMRM|||||0.255|0.167|<0.001
73964202|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.172|STANDARD_ERROR_OF_MEAN|0.0415|<|0.001|TWO_SIDED|95.0|-0.254|-0.091|||MMRM|||Week 4||-0.091|-0.254|<0.001
73964203|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.196|STANDARD_ERROR_OF_MEAN|0.0416|<|0.001|TWO_SIDED|95.0|-0.278|-0.115|||MMRM|||Week 4||-0.115|-0.278|<0.001
73964204|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.055|STANDARD_ERROR_OF_MEAN|0.0414||0.186|TWO_SIDED|95.0|-0.136|0.026|||MMRM|||Week 4||0.026|-0.136|0.186
73907735|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.953
73907736|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.647||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.647
73907737|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.507
73907738|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.821||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.821
73907739|NCT00785928|147345210|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.045
73907740|NCT00785928|147345213|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||Pairwise (2-sided) comparisons of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.236
73907741|NCT00785928|147345213|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Pairwise (2-sided) comparisons of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.038
73907742|NCT00785928|147345213|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Pairwise (2-sided) comparisons of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.025
73907743|NCT00785928|147345213|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Pairwise (2-sided) comparisons of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.005
73907744|NCT00785928|147345213|SUPERIORITY_OR_OTHER|||||||0.734||95.0||||Pairwise (2-sided) comparisons of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.734
73907745|NCT00785928|147345213|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||Pairwise (2-sided) comparisons of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.035
73964205|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.184|STANDARD_ERROR_OF_MEAN|0.0294|<|0.001|TWO_SIDED|95.0|-0.242|-0.127|||MMRM|||Week 4: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.127|-0.242|<0.001
73964206|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.129|STANDARD_ERROR_OF_MEAN|0.0431||0.003|TWO_SIDED|95.0|-0.214|-0.044|||MMRM|||Week 12||-0.044|-0.214|0.003
73907746|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.901||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.901
73964207|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.248|STANDARD_ERROR_OF_MEAN|0.0435|<|0.001|TWO_SIDED|95.0|-0.333|-0.162|||MMRM|||Week 12||-0.162|-0.333|<0.001
73907747|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.840
73964208|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.052|STANDARD_ERROR_OF_MEAN|0.0431||0.232|TWO_SIDED|95.0|-0.136|0.033|||MMRM|||Week 12||0.033|-0.136|0.232
73907748|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.882
73907749|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.225
73907750|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.340
73907751|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.850
73964209|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.188|STANDARD_ERROR_OF_MEAN|0.0307|<|0.001|TWO_SIDED|95.0|-0.248|-0.128|||MMRM|||Week 12: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.128|-0.248|<0.001
73964210|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.171|STANDARD_ERROR_OF_MEAN|0.0437|<|0.001|TWO_SIDED|95.0|-0.257|-0.086|||MMRM|||Week 26||-0.086|-0.257|<0.001
73964211|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.248|STANDARD_ERROR_OF_MEAN|0.0439|<|0.001|TWO_SIDED|95.0|-0.334|-0.162|||MMRM|||Week 26||-0.162|-0.334|<0.001
73964212|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.054|STANDARD_ERROR_OF_MEAN|0.0437||0.214|TWO_SIDED|95.0|-0.14|0.031|||MMRM|||Week 26||0.031|-0.140|0.214
74025878|NCT00756002|147604469|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.097
73856700|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|63.3|||<|0.001|TWO_SIDED|95.0|49.07|77.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||77.52|49.07|<0.001
73856701|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|56.81|||<|0.001|TWO_SIDED|95.0|42.28|71.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||71.34|42.28|<0.001
73856702|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.57|||<|0.001|TWO_SIDED|95.0|53.58|81.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.55|53.58|<0.001
73856703|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|53.31|||<|0.001|TWO_SIDED|95.0|38.62|67.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||67.99|38.62|<0.001
73856704|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.28||||0.14|TWO_SIDED|95.0|-3.26|23.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.82|-3.26|0.140
73856705|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.98||||0.674|TWO_SIDED|95.0|-10.94|16.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.89|-10.94|0.674
73856706|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.58||||0.034|TWO_SIDED|95.0|1.22|27.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.93|1.22|0.034
73856707|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|72.32|||<|0.001|TWO_SIDED|95.0|58.25|86.39||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.39|58.25|<0.001
73856708|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.2|||<|0.001|TWO_SIDED|95.0|52.63|81.78||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.78|52.63|<0.001
73856709|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|72.4|||<|0.001|TWO_SIDED|95.0|58.4|86.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.40|58.40|<0.001
73856710|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.12|||<|0.001|TWO_SIDED|95.0|49.32|78.91||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.91|49.32|<0.001
73907752|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.447||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.447
73856711|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.4||||0.119|TWO_SIDED|95.0|-2.06|18.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.85|-2.06|0.119
73907753|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.909||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.909
73964213|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.209|STANDARD_ERROR_OF_MEAN|0.031|<|0.001|TWO_SIDED|95.0|-0.27|-0.149|||MMRM|||Week 26: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.149|-0.270|<0.001
73964214|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.141|STANDARD_ERROR_OF_MEAN|0.0449||0.002|TWO_SIDED|95.0|-0.229|-0.053|||MMRM|||Week 52||-0.053|-0.229|0.002
73964215|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.266|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|95.0|-0.354|-0.177|||MMRM|||Week 52||-0.177|-0.354|<0.001
73964216|NCT02554786|147464422|SUPERIORITY||LS Mean|0.01|STANDARD_ERROR_OF_MEAN|0.0447||0.824|TWO_SIDED|95.0|-0.078|0.098|||MMRM|||Week 52||0.098|-0.078|0.824
73964217|NCT02554786|147464422|SUPERIORITY||LS Mean|-0.203|STANDARD_ERROR_OF_MEAN|0.0318|<|0.001|TWO_SIDED|95.0|-0.266|-0.141|||MMRM|||Week 52: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.141|-0.266|<0.001
73964218|NCT02554786|147464423|SUPERIORITY||LS Mean|0.136|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.09|0.183|||MMRM|||||0.183|0.090|<0.001
73964219|NCT02554786|147464423|SUPERIORITY||LS Mean|0.209|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.163|0.255|||MMRM|||||0.255|0.163|<0.001
73964220|NCT02554786|147464423|SUPERIORITY||LS Mean|0.048|STANDARD_ERROR_OF_MEAN|0.0234||0.04|TWO_SIDED|95.0|0.002|0.094|||MMRM|||||0.094|0.002|0.04
74025879|NCT00756002|147604470|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.028
73964221|NCT02554786|147464424|SUPERIORITY||LS Mean|0.132|STANDARD_ERROR_OF_MEAN|0.0193|<|0.001|TWO_SIDED|95.0|0.094|0.17|||MMRM|||Day 30||0.170|0.094|<0.001
73964222|NCT02554786|147464424|SUPERIORITY||LS Mean|0.196|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.158|0.234|||MMRM|||Day 30||0.234|0.158|<0.001
73964223|NCT02554786|147464424|SUPERIORITY||LS Mean|0.035|STANDARD_ERROR_OF_MEAN|0.0192||0.064|TWO_SIDED|95.0|-0.002|0.073|||MMRM|||Day 30||0.073|-0.002|0.064
73964224|NCT02554786|147464424|SUPERIORITY||LS Mean|0.122|STANDARD_ERROR_OF_MEAN|0.0201|<|0.001|TWO_SIDED|95.0|0.083|0.162|||MMRM|||Day 86||0.162|0.083|<0.001
73964225|NCT02554786|147464424|SUPERIORITY||LS Mean|0.184|STANDARD_ERROR_OF_MEAN|0.0202|<|0.001|TWO_SIDED|95.0|0.144|0.224|||MMRM|||Day 86||0.224|0.144|<0.001
73964226|NCT02554786|147464424|SUPERIORITY||LS Mean|0.037|STANDARD_ERROR_OF_MEAN|0.02||0.063|TWO_SIDED|95.0|-0.002|0.076|||MMRM|||Day 86||0.076|-0.002|0.063
73964227|NCT02554786|147464425|SUPERIORITY||LS Mean|0.142|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.119|0.164|||MMRM|||Day 1: 5 minutes||0.164|0.119|<0.001
73964228|NCT02554786|147464425|SUPERIORITY||LS Mean|0.152|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.129|0.175|||MMRM|||Day 1: 5 minutes||0.175|0.129|<0.001
73964229|NCT02554786|147464425|SUPERIORITY||LS Mean|0.055|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.032|0.078|||MMRM|||Day 1: 5 minutes||0.078|0.032|<0.001
73964230|NCT02554786|147464425|SUPERIORITY||LS Mean|0.162|STANDARD_ERROR_OF_MEAN|0.0122|<|0.001|TWO_SIDED|95.0|0.138|0.186|||MMRM|||Day 1: 15 minutes||0.186|0.138|<0.001
73964231|NCT02554786|147464425|SUPERIORITY||LS mean|0.174|STANDARD_ERROR_OF_MEAN|0.0123|<|0.001|TWO_SIDED|95.0|0.15|0.198|||MMRM|||Day 1: 15 minutes||0.198|0.150|<.001
73964232|NCT02554786|147464425|SUPERIORITY||LS Mean|0.044|STANDARD_ERROR_OF_MEAN|0.0122|<|0.001|TWO_SIDED|95.0|0.02|0.068|||MMRM|||Day1: 15 minutes||0.068|0.02|<0.001
73964233|NCT02554786|147464425|SUPERIORITY||LS Mean|0.175|STANDARD_ERROR_OF_MEAN|0.0132|<|0.001|TWO_SIDED|95.0|0.149|0.201|||MMRM|||Day 1: 30 minutes||0.201|0.149|<0.001
73964234|NCT02554786|147464425|SUPERIORITY||LS Mean|0.185|STANDARD_ERROR_OF_MEAN|0.0132|<|0.001|TWO_SIDED|95.0|0.159|0.211|||MMRM|||Day 1: 30 minutes||0.211|0.159|<0.001
73964235|NCT02554786|147464425|SUPERIORITY||LS Mean|0.027|STANDARD_ERROR_OF_MEAN|0.0132||0.038|TWO_SIDED|95.0|0.001|0.053|||MMRM|||Day 1: 30 minutes||0.053|0.001|0.038
73964236|NCT02554786|147464425|SUPERIORITY||LS Mean|0.178|STANDARD_ERROR_OF_MEAN|0.0139|<|0.001|TWO_SIDED|95.0|0.15|0.205|||MMRM|||Day 1: 1 hour||0.205|0.150|<0.001
73964237|NCT02554786|147464425|SUPERIORITY||LS Mean|0.205|STANDARD_ERROR_OF_MEAN|0.0139|<|0.001|TWO_SIDED|95.0|0.177|0.232|||MMRM|||Day 1: 1hour||0.232|0.177|<0.001
73964238|NCT02554786|147464425|SUPERIORITY||LS Mean|0.007|STANDARD_ERROR_OF_MEAN|0.0139||0.632|TWO_SIDED|95.0|-0.021|0.034|||MMRM|||Day 1: 1hour||0.034|-0.021|0.632
73964239|NCT02554786|147464425|SUPERIORITY||LS Mean|0.189|STANDARD_ERROR_OF_MEAN|0.0192|<|0.001|TWO_SIDED|95.0|0.151|0.226|||MMRM|||Day 30: 5 minutes||0.226|0.151|<0.001
73964240|NCT02554786|147464425|SUPERIORITY||LS Mean|0.232|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.194|0.27|||MMRM|||Day 30: 5 minutes||0.270|0.194|<0.001
73964241|NCT02554786|147464425|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0191||0.005|TWO_SIDED|95.0|0.016|0.091|||MMRM|||Day 30: 5 minutes||0.091|0.016|0.005
73964242|NCT02554786|147464425|SUPERIORITY||LS Mean|0.194|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.156|0.232|||MMRM|||Day 30: 30 minutes||0.232|0.156|<0.001
73964243|NCT02554786|147464425|SUPERIORITY||LS Mean|0.253|STANDARD_ERROR_OF_MEAN|0.0196|<|0.001|TWO_SIDED|95.0|0.214|0.291|||MMRM|||Day 30: 30 minutes||0.291|0.214|<0.001
73964244|NCT02554786|147464425|SUPERIORITY||LS Mean|0.043|STANDARD_ERROR_OF_MEAN|0.0192||0.026|TWO_SIDED|95.0|0.005|0.08|||MMRM|||Day 30: 30 minutes||0.08|0.005|0.026
73964245|NCT02554786|147464425|SUPERIORITY||LS Mean|0.19|STANDARD_ERROR_OF_MEAN|0.0196|<|0.001|TWO_SIDED|95.0|0.152|0.229|||MMRM|||Day 30: 1 hour||0.229|0.152|<0.001
73964246|NCT02554786|147464425|SUPERIORITY||LS Mean|0.258|STANDARD_ERROR_OF_MEAN|0.0198|<|0.001|TWO_SIDED|95.0|0.219|0.296|||MMRM|||Day 30: 1 hour||0.296|0.219|<0.001
73964247|NCT02554786|147464425|SUPERIORITY||LS Mean|0.037|STANDARD_ERROR_OF_MEAN|0.0194||0.059|TWO_SIDED|95.0|-0.001|0.075|||MMRM|||Day 30: 1 hour||0.075|-0.001|0.059
73964248|NCT02554786|147464425|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0204|<|0.001|TWO_SIDED|95.0|0.123|0.203|||MMRM|||Day 86: 5 minutes||0.203|0.123|<0.001
73964249|NCT02554786|147464425|SUPERIORITY||LS Mean|0.231|STANDARD_ERROR_OF_MEAN|0.0206|<|0.001|TWO_SIDED|95.0|0.191|0.271|||MMRM|||Day 86: 5 minutes||0.271|0.191|<0.001
73964250|NCT02554786|147464425|SUPERIORITY||LS Mean|0.055|STANDARD_ERROR_OF_MEAN|0.0203||0.007|TWO_SIDED|95.0|0.015|0.095|||MMRM|||Day 86: 5minutes||0.095|0.015|0.007
73964251|NCT02554786|147464425|SUPERIORITY||LS Mean|0.18|STANDARD_ERROR_OF_MEAN|0.0203|<|0.001|TWO_SIDED|95.0|0.14|0.219|||MMRM|||Day 86: 30 minutes||0.219|0.140|<0.001
73964252|NCT02554786|147464425|SUPERIORITY||LS Mean|0.252|STANDARD_ERROR_OF_MEAN|0.0205|<|0.001|TWO_SIDED|95.0|0.211|0.292|||MMRM|||Day 86: 30 minutes||0.292|0.211|<0.001
73964253|NCT02554786|147464425|SUPERIORITY||LS Mean|0.038|STANDARD_ERROR_OF_MEAN|0.0202||0.057|TWO_SIDED|95.0|-0.001|0.078|||MMRM|||Day 86: 30 minutes||0.078|-0.001|0.057
73964254|NCT02554786|147464425|SUPERIORITY||LS Mean|0.187|STANDARD_ERROR_OF_MEAN|0.0205|<|0.001|TWO_SIDED|95.0|0.147|0.227|||MMRM|||Day 86: 1 hour||0.227|0.147|<0.001
73964255|NCT02554786|147464425|SUPERIORITY||LS Mean|0.249|STANDARD_ERROR_OF_MEAN|0.0208|<|0.001|TWO_SIDED|95.0|0.208|0.289|||MMRM|||Day 86: 1 hour||0.289|0.208|<0.001
73964256|NCT02554786|147464425|SUPERIORITY||LS Mean|0.043|STANDARD_ERROR_OF_MEAN|0.0205||0.037|TWO_SIDED|95.0|0.003|0.083|||MMRM|||Day 86: 1hour||0.083|0.003|0.037
73964257|NCT02554786|147464425|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|95.0|0.121|0.206|||MMRM|||Day 183: 5 minutes||0.206|0.121|<0.001
73907754|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.152
73907755|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.023
73907756|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.004
73907757|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.017
73964258|NCT02554786|147464425|SUPERIORITY||LS Mean|0.243|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.2|0.286|||MMRM|||Day 183: 5 minutes||0.286|0.200|<0.001
73907758|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.944
73907759|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.677
73964259|NCT02554786|147464425|SUPERIORITY||LS Mean|0.044|STANDARD_ERROR_OF_MEAN|0.0216||0.041|TWO_SIDED|95.0|0.002|0.087|||MMRM|||Day 183: 5 minutes||0.087|0.002|0.041
73964260|NCT02554786|147464425|SUPERIORITY||LS Mean|0.176|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.133|0.22|||MMRM|||Day 183: 30 minutes||0.220|0.133|<0.001
73964261|NCT02554786|147464425|SUPERIORITY||LS Mean|0.259|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.215|0.303|||MMRM|||Day 183: 30 minutes||0.303|0.215|<0.001
74025880|NCT00756002|147604471|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.003
74025881|NCT00756002|147604472|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.111
74025882|NCT00644592|147604481|SUPERIORITY_OR_OTHER||Ratio of mean effects|1.27|STANDARD_ERROR_OF_MEAN|0.16||0.015|TWO_SIDED|95.0|1.06|1.52|||t-test, 2 sided||The estimated mean log difference (SE) between the period 2 and period 1 effects and SE was estimated. This estimates twice the effect size\[since (B-A)-(A-B)=2B-2A\] so the actual estimate was based upon the antilog of half of this difference.|This is a crossover analysis. To convert to a ratio effect, the mean difference must be divided by two and antilogs take. The outcome represents a relative effect.||1.52|1.06|0.015
74025883|NCT00749606|147604492|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Mixed linear models analyzed within-subject variation in repeated measures over time. Intention to treat analysis used 5 imputations for missing data.||||||<0.01
73964262|NCT02554786|147464425|SUPERIORITY||LS Mean|0.04|STANDARD_ERROR_OF_MEAN|0.0221||0.071|TWO_SIDED|95.0|-0.003|0.083|||MMRM|||Day 183: 30 minutes||0.083|-0.003|0.071
73964263|NCT02554786|147464425|SUPERIORITY||LS Mean|0.18|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.137|0.223|||MMRM|||Day 183: 1 hour||0.223|0.137|<0.001
73964264|NCT02554786|147464425|SUPERIORITY||LS Mean|0.259|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.215|0.302|||MMRM|||Day 183: 1 hour||0.302|0.215|<0.001
73964265|NCT02554786|147464425|SUPERIORITY||LS Mean|0.039|STANDARD_ERROR_OF_MEAN|0.0218||0.071|TWO_SIDED|95.0|-0.003|0.082|||MMRM|||Day 183: 1 hour||0.082|-0.003|0.071
73964266|NCT02554786|147464425|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0229|<|0.001|TWO_SIDED|95.0|0.094|0.184|||MMRM|||Day 364: 5 minutes||0.184|0.094|<0.001
73964267|NCT02554786|147464425|SUPERIORITY||LS Mean|0.249|STANDARD_ERROR_OF_MEAN|0.0228|<|0.001|TWO_SIDED|95.0|0.205|0.294|||MMRM|||Day 364: 5 minutes||0.294|0.205|<0.001
73964268|NCT02554786|147464425|SUPERIORITY||LS Mean|0.026|STANDARD_ERROR_OF_MEAN|0.0227||0.244|TWO_SIDED|95.0|-0.018|0.071|||MMRM|||Day 364: 5 minutes||0.071|-0.018|0.244
73964269|NCT02554786|147464425|SUPERIORITY||LS Mean|0.155|STANDARD_ERROR_OF_MEAN|0.0228|<|0.001|TWO_SIDED|95.0|0.11|0.2|||MMRM|||Day 364: 30 minutes||0.200|0.110|<0.001
73964270|NCT02554786|147464425|SUPERIORITY||LS Mean|0.264|STANDARD_ERROR_OF_MEAN|0.0227|<|0.001|TWO_SIDED|95.0|0.219|0.308|||MMRM|||Day 364: 30 minutes||0.308|0.219|<0.001
73964271|NCT02554786|147464425|SUPERIORITY||LS Mean|0.032|STANDARD_ERROR_OF_MEAN|0.0226||0.162|TWO_SIDED|95.0|-0.013|0.076|||MMRM|||Day 364: 30 minutes||0.076|-0.013|0.162
73964272|NCT02554786|147464425|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0234|<|0.001|TWO_SIDED|95.0|0.117|0.209|||MMRM|||Day 364: 1 hour||0.209|0.117|<0.001
73907760|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.053
73907761|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.061
73907762|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.025
73907763|NCT00785928|147345214|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.030
73907764|NCT03387683|147345216|OTHER||Difference in LSM|0.31121|STANDARD_ERROR_OF_MEAN|0.46184||0.504|TWO_SIDED|95.0|-0.619|1.24141||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo-Dapagliflozin 10 mg)||1.24141|-0.61900|0.504
73907765|NCT03387683|147345217|OTHER||Difference in LSM|1.74969|STANDARD_ERROR_OF_MEAN|2.18363||0.427|TWO_SIDED|95.0|-2.64837|6.14775||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo - Dapagliflozin 10 mg)||6.14775|-2.64837|0.427
73907766|NCT02437383|147345246|SUPERIORITY||LSM Difference (Final Values)|-1.8||||0.414|TWO_SIDED|95.0|-6.2|2.6||P-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|Covariates for site, baseline value, sex, race, treatment, visit, a treatment\*visit interaction, and an unstructured covariance structure.||||2.6|-6.2|0.414
73907767|NCT02083081|147345336|SUPERIORITY|||||||0.38|||||||generalized estimating equations (GEE)|||||||0.38
73907768|NCT02083081|147345337|SUPERIORITY|||||||0.45|||||||generalized estimating equations (GEE)|||||||0.45
73907769|NCT02083081|147345338|SUPERIORITY|||||||0.96|||||||generalized estimating equations (GEE)|||||||0.96
73907770|NCT01104155|147345339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204|||||||1-sided exact binomial|Based on a one-sided exact binomial test compared to 9%.||||||0.204
74085140|NCT00407745|147723844|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.81||||0.0024|TWO_SIDED|95.0|1.443|5.491||Significance was declared if p-value \<=0.05|Regression, Logistic|Logistic Regression Model included Pooled Center and Treatment as the categorical factors, and Optimal Sleep Score at Baseline as the covariate.||Null hypothesis - The rate of subjects with optimal sleep for the pregabain group was equal to the rate of subjects with optimal sleep for the placebo group; Alternative hypothesis - The rate of subjects with optimal sleep for the pregabain group was not equal to the rate of subjects with optimal sleep for the placebo group.||5.491|1.443|0.0024
73856712|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.84||||0.616|TWO_SIDED|95.0|-8.3|13.98||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.98|-8.30|0.616
73856713|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.34||||0.125|TWO_SIDED|95.0|-2.2|18.87||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.87|-2.20|0.125
73907771|NCT01104155|147345339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|||||||1-sided exact binomial|||||||0.041
73907772|NCT01484132|147345346|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline to 6 months was different from 0.||||0.58
73907773|NCT01484132|147345346|SUPERIORITY_OR_OTHER||Slope|-0.061||||0.406|TWO_SIDED|95.0|-0.206|0.084||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.084|-0.206|0.406
73907774|NCT01484132|147345346|SUPERIORITY_OR_OTHER||Slope|-0.017||||0.693|TWO_SIDED|95.0|-0.101|0.067||P-value is to test the longitudinal association between composite exposure on all surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on all surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.067|-0.101|0.693
73907775|NCT01484132|147345346|SUPERIORITY_OR_OTHER||Slope|-0.123||||0.16|TWO_SIDED|95.0|-0.296|0.05||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.050|-0.296|0.160
73964273|NCT02554786|147464425|SUPERIORITY||LS Mean|0.262|STANDARD_ERROR_OF_MEAN|0.0232|<|0.001|TWO_SIDED|95.0|0.216|0.308|||MMRM|||Day 364: 1 hour||0.308|0.216|<0.001
73856714|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.49|||<|0.001|TWO_SIDED|95.0|60.73|88.25||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.25|60.73|<0.001
73964274|NCT02554786|147464425|SUPERIORITY||LS Mean|0.031|STANDARD_ERROR_OF_MEAN|0.0231||0.182|TWO_SIDED|95.0|-0.014|0.076|||MMRM|||Day 364: 1 hour||0.076|-0.014|0.182
73964275|NCT02554786|147464426|SUPERIORITY||LS Mean|0.086|STANDARD_ERROR_OF_MEAN|0.0237|<|0.001|TWO_SIDED|95.0|0.04|0.133|||MMRM|||Day 2||0.133|0.040|<0.001
73964276|NCT02554786|147464426|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.093|0.185|||MMRM|||Day 2||0.185|0.093|<0.001
73964277|NCT02554786|147464426|SUPERIORITY||LS Mean|-0.002|STANDARD_ERROR_OF_MEAN|0.0237||0.927|TWO_SIDED|95.0|-0.049|0.044|||MMRM|||Day 2||0.044|-0.049|0.927
73964278|NCT02554786|147464426|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0246||0.044|TWO_SIDED|95.0|0.001|0.098|||MMRM|||Day 184||0.098|0.001|0.044
73964279|NCT02554786|147464426|SUPERIORITY||LS Mean|0.141|STANDARD_ERROR_OF_MEAN|0.0246|<|0.001|TWO_SIDED|95.0|0.093|0.19|||MMRM|||Day 184||0.190|0.093|<0.001
73964280|NCT02554786|147464426|SUPERIORITY||LS Mean|0.017|STANDARD_ERROR_OF_MEAN|0.0244||0.49|TWO_SIDED|95.0|-0.031|0.065|||MMRM|||Day 184||0.065|-0.031|0.490
73856715|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.38|||<|0.001|TWO_SIDED|95.0|55.05|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.71|55.05|<0.001
73856716|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.52|||<|0.001|TWO_SIDED|95.0|59.65|87.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||87.38|59.65|<0.001
73856717|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.36|||<|0.001|TWO_SIDED|95.0|54.01|82.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||82.71|54.01|<0.001
73856718|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.33||||0.187|TWO_SIDED|95.0|-2.99|15.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.65|-2.99|0.187
73856719|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.79||||0.881|TWO_SIDED|95.0|-9.42|10.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.99|-9.42|0.881
73964281|NCT02554786|147464426|SUPERIORITY||LS Mean|0.076|STANDARD_ERROR_OF_MEAN|0.0249||0.002|TWO_SIDED|95.0|0.027|0.125|||MMRM|||Day 365||0.125|0.027|0.002
73964282|NCT02554786|147464426|SUPERIORITY||LS Mean|0.146|STANDARD_ERROR_OF_MEAN|0.0248|<|0.001|TWO_SIDED|95.0|0.098|0.195|||MMRM|||Day 365||0.195|0.098|<0.001
73964283|NCT02554786|147464426|SUPERIORITY||LS Mean|0.036|STANDARD_ERROR_OF_MEAN|0.0248||0.143|TWO_SIDED|95.0|-0.012|0.085|||MMRM|||Day 365||0.085|-0.012|0.143
73964284|NCT02554786|147464427|SUPERIORITY||LS Mean|0.189|STANDARD_ERROR_OF_MEAN|0.0253|<|0.001|TWO_SIDED|95.0|0.139|0.238|||MMRM|||Day 2||0.238|0.139|<0.001
73856720|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.05||||0.311|TWO_SIDED|95.0|-4.6|14.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.71|-4.60|0.311
73964285|NCT02554786|147464427|SUPERIORITY||LS Mean|0.21|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.161|0.259|||MMRM|||Day 2||0.259|0.161|<0.001
73964286|NCT02554786|147464427|SUPERIORITY||LS Mean|-0.018|STANDARD_ERROR_OF_MEAN|0.0252||0.475|TWO_SIDED|95.0|-0.067|0.031|||MMRM|||Day 2||0.031|-0.067|0.475
73964287|NCT02554786|147464427|SUPERIORITY||LS Mean|0.228|STANDARD_ERROR_OF_MEAN|0.0345|<|0.001|TWO_SIDED|95.0|0.161|0.296|||MMRM|||Day 184||0.296|0.161|<0.001
73964288|NCT02554786|147464427|SUPERIORITY||LS Mean|0.265|STANDARD_ERROR_OF_MEAN|0.0346|<|0.001|TWO_SIDED|95.0|0.197|0.333|||MMRM|||Day 184||0.333|0.197|<0.001
73964289|NCT02554786|147464427|SUPERIORITY||LS Mean|0.083|STANDARD_ERROR_OF_MEAN|0.0343||0.015|TWO_SIDED|95.0|0.016|0.151|||MMRM|||Day 184||0.151|0.016|0.015
73964290|NCT02554786|147464427|SUPERIORITY||LS Mean|0.215|STANDARD_ERROR_OF_MEAN|0.0358|<|0.001|TWO_SIDED|95.0|0.145|0.285|||MMRM|||Day 365||0.285|0.145|<0.001
73964291|NCT02554786|147464427|SUPERIORITY||LS Mean|0.246|STANDARD_ERROR_OF_MEAN|0.0357|<|0.001|TWO_SIDED|95.0|0.176|0.316|||MMRM|||Day 365||0.316|0.176|<0.001
73964292|NCT02554786|147464427|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0356||0.139|TWO_SIDED|95.0|-0.017|0.122|||MMRM|||Day 365||0.122|-0.017|0.139
73964293|NCT02554786|147464428|SUPERIORITY||LS Mean|29.6|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|23.8|35.4|||Linear Mixed Model (LMM)|||Week 26: Mean morning PEF||35.4|23.8|<0.001
73964294|NCT02554786|147464428|SUPERIORITY||LS Mean|32.2|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|26.4|38.1|||LMM|||Week 26: Mean morning PEF||38.1|26.4|<0.001
73964295|NCT02554786|147464428|SUPERIORITY||LS Mean|13.3|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|7.5|19.1|||LMM|||Week 26: Mean morning PEF||19.1|7.5|<0.001
74085141|NCT00407745|147723845|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.433||0.1164|TWO_SIDED|95.0|-1.54|0.17||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Anxiety as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.17|-1.54|0.1164
73907776|NCT01484132|147345346|SUPERIORITY_OR_OTHER||Slope|-0.029||||0.574|TWO_SIDED|95.0|-0.131|0.073||P-value is to test the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.073|-0.131|0.574
73907777|NCT01484132|147345347|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.11
73907778|NCT01484132|147345347|SUPERIORITY_OR_OTHER||Slope|0.299||||0.003|TWO_SIDED|95.0|0.105|0.494||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.494|0.105|0.003
73907779|NCT01484132|147345347|SUPERIORITY_OR_OTHER||Slope|0.365||||0.002|TWO_SIDED|95.0|0.145|0.585||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.585|0.145|0.002
73907780|NCT01484132|147345348|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.27
73907781|NCT01484132|147345348|SUPERIORITY_OR_OTHER||Slope|-0.068||||0.48|TWO_SIDED|95.0|-0.258|0.123||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.123|-0.258|0.480
73907782|NCT01484132|147345348|SUPERIORITY_OR_OTHER||Slope|-0.074||||0.501|TWO_SIDED|95.0|-0.293|0.145||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.145|-0.293|0.501
73907783|NCT01484132|147345349|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.41
73964296|NCT02554786|147464428|SUPERIORITY||LS Mean|24.8|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|19.3|30.3|||LMM|||Week 26: Mean evening PEF||30.3|19.3|<0.001
73907784|NCT01484132|147345349|SUPERIORITY_OR_OTHER||Slope|-0.082||||0.612|TWO_SIDED|95.0|-0.418|0.254||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.254|-0.418|0.612
73907785|NCT01484132|147345349|SUPERIORITY_OR_OTHER||Slope|0.078||||0.696|TWO_SIDED|95.0|-0.339|0.495||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.495|-0.339|0.696
73964297|NCT02554786|147464428|SUPERIORITY||LS Mean|30.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|24.8|35.9|||LMM|||Week 26: Mean evening PEF||35.9|24.8|<0.001
73964298|NCT02554786|147464428|SUPERIORITY||LS Mean|8.6|STANDARD_ERROR_OF_MEAN|2.83||0.002|TWO_SIDED|95.0|3.1|14.2|||LMM|||Week 26: Mean evening PEF||14.2|3.1|0.002
73964299|NCT02554786|147464428|SUPERIORITY||LS Mean|28.7|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|22.7|34.8|||LMM|||Week 52: Mean morning PEF||34.8|22.7|<0.001
73964300|NCT02554786|147464428|SUPERIORITY||LS Mean|30.2|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|24.2|36.3|||LMM|||Week 52: Mean morning PEF||36.3|24.2|<0.001
73964301|NCT02554786|147464428|SUPERIORITY||LS Mean|13.8|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|7.7|19.8|||LMM|||Week 52: Mean morning PEF||19.8|7.7|<0.001
73907786|NCT01484132|147345350|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.76
73907787|NCT01484132|147345350|SUPERIORITY_OR_OTHER||Slope|-0.018||||0.968|TWO_SIDED|95.0|-1.061|1.025||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||1.025|-1.061|0.968
73907788|NCT01484132|147345350|SUPERIORITY_OR_OTHER||Slope|-0.083||||0.822|TWO_SIDED|95.0|-0.941|0.775||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.775|-0.941|0.822
73907789|NCT02770170|147345379|OTHER|||||||0.7271||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod quadratic model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.7271
73907790|NCT02770170|147345379|OTHER|||||||0.6415||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod sigmoidal Emax model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.6415
73907791|NCT02770170|147345379|OTHER|||||||0.7367||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Emax model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.7367
73964302|NCT02554786|147464428|SUPERIORITY||LS Mean|23.7|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|18.0|29.5|||LMM|||Week 52: Mean evening PEF||29.5|18.0|<0.001
73964303|NCT02554786|147464428|SUPERIORITY||LS Mean|29.1|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|23.3|34.8|||LMM|||Week 52: Mean evening PEF||34.8|23.3|<0.001
73964304|NCT02554786|147464428|SUPERIORITY||LS Mean|9.1|STANDARD_ERROR_OF_MEAN|2.95||0.002|TWO_SIDED|95.0|3.3|14.9|||LMM|||Week 52: Mean evening PEF||14.9|3.3|0.002
73964305|NCT02554786|147464429|SUPERIORITY||Odds Ratio (OR)|1.31||||0.094|TWO_SIDED|95.0|0.95|1.81|||Logistic regression model|||Day 183||1.81|0.95|0.094
73964306|NCT02554786|147464429|SUPERIORITY||Odds Ratio (OR)|1.73|||<|0.001|TWO_SIDED|95.0|1.26|2.37|||Logistic regression model|||Day 183||2.37|1.26|<0.001
73964307|NCT02554786|147464429|SUPERIORITY||Odds Ratio (OR)|1.06||||0.746|TWO_SIDED|95.0|0.76|1.46|||Logistic regression model|||Day 183||1.46|0.76|0.746
73907792|NCT02770170|147345379|OTHER|||||||0.6624||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod exponential model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.6624
73907793|NCT02770170|147345379|OTHER||Risk Difference (RD)|-10.0||||0.4645|TWO_SIDED|80.0|-27.292|7.288|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||7.288|-27.292|0.4645
73907794|NCT02770170|147345379|OTHER||Risk Difference (RD)|-3.38||||0.8084|TWO_SIDED|80.0|-21.204|14.451|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||14.451|-21.204|0.8084
73964308|NCT02554786|147464429|SUPERIORITY||Odds Ratio (OR)|1.34||||0.088|TWO_SIDED|95.0|0.96|1.87|||Logistic regression model|||Day 364||1.87|0.96|0.088
73907795|NCT02770170|147345379|OTHER||Risk Difference (RD)|-3.77||||0.7398|TWO_SIDED|80.0|-18.364|10.832|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||10.832|-18.364|0.7398
73907796|NCT02770170|147345380|OTHER||Risk Difference (RD)|-8.93||||0.5773|TWO_SIDED|80.0|-23.66|7.64|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||7.64|-23.66|0.5773
73907797|NCT02770170|147345380|OTHER||Risk Difference (RD)|12.5||||0.4013|TWO_SIDED|80.0|-4.59|29.03|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||29.03|-4.59|0.4013
73907798|NCT02770170|147345380|OTHER||Risk Difference (RD)|-2.5||||0.8965|TWO_SIDED|80.0|-15.98|11.1|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||11.10|-15.98|0.8965
73964309|NCT02554786|147464429|SUPERIORITY||Odds Ratio (OR)|2.24|||<|0.001|TWO_SIDED|95.0|1.58|3.17|||Logistic regression model|||Day 364||3.17|1.58|<0.001
73964310|NCT02554786|147464429|SUPERIORITY||Odds Ratio (OR)|1.05||||0.771|TWO_SIDED|95.0|0.75|1.49|||Logistic regression model|||Day 364||1.49|0.75|0.771
73964311|NCT02554786|147464430|SUPERIORITY||LS Mean|5.8|STANDARD_ERROR_OF_MEAN|2.29||0.012|TWO_SIDED|95.0|1.3|10.2|||Linear Mixed Model (LMM)|||||10.2|1.3|0.012
73964312|NCT02554786|147464430|SUPERIORITY||LS Mean|9.1|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|4.6|13.6|||LMM|||||13.6|4.6|<0.001
73964313|NCT02554786|147464430|SUPERIORITY||LS Mean|3.4|STANDARD_ERROR_OF_MEAN|2.29||0.135|TWO_SIDED|95.0|-1.1|7.9|||LMM|||||7.9|-1.1|0.135
73964314|NCT02554786|147464431|SUPERIORITY||LS Mean|5.0|STANDARD_ERROR_OF_MEAN|2.25||0.026|TWO_SIDED|95.0|0.6|9.4|||LMM|||||9.4|0.6|0.026
73964315|NCT02554786|147464431|SUPERIORITY||LS Mean|8.1|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|3.7|12.5|||LMM|||||12.5|3.7|<0.001
73964316|NCT02554786|147464431|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|2.25||0.151|TWO_SIDED|95.0|-1.2|7.7|||LMM|||||7.7|-1.2|0.151
73907799|NCT02770170|147345381|OTHER||Risk Difference (RD)|-19.64||||0.1476|TWO_SIDED|80.0|-35.38|-2.48|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-2.48|-35.38|0.1476
73907800|NCT02770170|147345381|OTHER||Risk Difference (RD)|12.5||||0.4013|TWO_SIDED|80.0|-4.2|26.86|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||26.86|-4.20|0.4013
73907801|NCT02770170|147345381|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|80.0|-13.63|13.63|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||13.63|-13.63|
73907802|NCT02770170|147345382|OTHER||Risk Difference (RD)|-26.67||||0.0512|TWO_SIDED|80.0|-41.52|-9.42|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-9.42|-41.52|0.0512
73907803|NCT02770170|147345382|OTHER||Risk Difference (RD)|5.0||||0.7597|TWO_SIDED|80.0|-12.1|20.74|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||20.74|-12.10|0.7597
73907804|NCT02770170|147345382|OTHER||Risk Difference (RD)|-5.0||||0.7505|TWO_SIDED|80.0|-18.74|9.02|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||9.02|-18.74|0.7505
73907805|NCT02770170|147345383|OTHER||Risk Difference (RD)|-21.43||||0.1269|TWO_SIDED|80.0|-36.03|-4.41|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-4.41|-36.03|0.1269
73907806|NCT02770170|147345383|OTHER||Risk Difference (RD)|5.0||||0.7889|TWO_SIDED|80.0|-12.24|21.62|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||21.62|-12.24|0.7889
73907807|NCT02770170|147345383|OTHER||Risk Difference (RD)|-12.5||||0.2906|TWO_SIDED|80.0|-25.99|1.68|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||1.68|-25.99|0.2906
73907808|NCT02770170|147345384|OTHER||Risk Difference (RD)|-9.64||||0.5687|TWO_SIDED|80.0|-25.79|7.45|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||7.45|-25.79|0.5687
73907809|NCT02770170|147345384|OTHER||Risk Difference (RD)|2.5||||0.9217|TWO_SIDED|80.0|-14.67|19.17|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||19.17|-14.67|0.9217
73907810|NCT02770170|147345384|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|80.0|-14.03|14.03|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||14.03|-14.03|
74085142|NCT00407745|147723846|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.447||0.0279|TWO_SIDED|95.0|-1.87|-0.11||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Depression as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.11|-1.87|0.0279
73907811|NCT02979197|147345405|NON_INFERIORITY|A two-sample t-test was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib (arm 1) was non-inferior to half of the effect achieved with Amlodipine+Placebo (arm 2). The primary efficacy endpoint was considered met if the lower limits of the 97.5% one-side confidence interval (CI) for the difference in SBPday change in arm 1 and 50% of the mean change in arm 2 was less than 0.||||||0.024|||||||t-test, 2 sided|||LOCF method was used. Primary efficacy analysis was based on the difference between the Amlodipine+Celecoxib and Amlodipine+Placebo (arms 1 and 2, respectively) in the mean change in SBPday from Baseline to final (Day 13), where a subject completed the 14-day treatment plan, or to Day 6, where a subject was withdrawn from treatment before the Day 13 dose but after the Day 6 dose, or to baseline, where a subject was withdrawn before the Day 6 dose.||||0.024
73907812|NCT02979197|147345406|OTHER|ANOVA F-test was used to compare the mean changes in body weight from baseline to end of treatment among the three treatment arms. The omni-bus test was to conclude if any differences existed.||||||0.006|||||||ANOVA|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in body weight was the 1st of the four secondary efficacy endpoints.||||0.006
73907813|NCT02979197|147345407|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered SBP24h to a greater degree than Amlodipine+Placebo.||||||0.826|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in SBP24h was the 2nd of the four secondary efficacy endpoints.||||0.826
73907814|NCT02979197|147345408|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered DBP24h to a greater degree than Amlodipine+Placebo.||||||0.5|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in DBP24h was the 3rd of the 4 secondary efficacy endpoints.||||0.500
73907815|NCT02979197|147345409|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib improved creatinine clearance to a greater degree than Amlodipine+Placebo.||||||0.668|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in creatinine clearance was the 4th of 4 secondary efficacy endpoints.||||0.668
73856721|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856722|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
74085143|NCT01186016|147723851|OTHER||||||<|0.01||||||A priori threshold for the P-Value was.05 or less.|ANOVA|||The scores on the Genetic Knowledge Test for both groups between baseline and the end of the educational sessions were analyzed with repeated measures ANOVA.||||<0.01
74085144|NCT01186016|147723852|OTHER|||||||0.44||||||The a priori threshold for statistical significance was a P-Value of .05 or less.|ANOVA|||Data for Self-Efficacy for Quitting/Resisting Smoking were analyzed with repeated measures ANOVA using three time points: baseline, end of the educational sessions, and end of the smoking cessation sessions.||||0.44
73856723|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73856724|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73856725|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856726|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856727|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856728|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856729|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73856730|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73856731|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73907816|NCT02979197|147345410|SUPERIORITY|Differences in the occurrence of TEAEs between treatment arms were evaluated using Chi-square test.||||||0.675|||||||Chi-squared|Computed on the number of subjects who had at least one TEAE.||||||0.675
73907817|NCT02979197|147345410|SUPERIORITY|||||||0.555|||||||Regression, Logistic|TEAE (1=at least one TEAE occurred for the subject; 0=otherwise) as dependent variable and treatment as fixed effect.||||||0.555
73907818|NCT02979197|147345411|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification were treated as 0.||||0.226
73907819|NCT02979197|147345412|SUPERIORITY|||||||0.215|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification (BLQ) were treated as 0.04 ng/mL. Assignment of BLQ values to a nonzero number allowed computation of the log transformation. The selection of 0.04 ng/mL was based on the lower limit of quantification of the validated bioanalytical method (0.05 ng/mL) and selecting the next lowest number at the hundredth decimal place.||||0.215
73907820|NCT02979197|147345413|SUPERIORITY|||||||0.0005|||||||ANCOVA|Adjusted mean = -3.48 μmol/L; 95% confidence interval = -5.4 to -1.6||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Celecoxib arm from baseline to Day 14.||||0.0005
73907821|NCT02979197|147345413|SUPERIORITY|||||||0.075|||||||ANCOVA|Adjusted mean = -1.72 μmol/L; 95% confidence interval = -3.6 to 0.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Placebo arm from baseline to Day 14.||||0.0750
73907822|NCT02979197|147345413|SUPERIORITY|||||||0.4184|||||||ANCOVA|Adjusted mean = -1.92 μmol/L; 95% confidence interval = -6.6 to 2.8||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Placebo+Placebo arm from baseline to Day 14.||||0.4184
73907823|NCT02979197|147345413|SUPERIORITY|||||||0.2022|||||||ANCOVA|Adjusted mean = -1.76 μmol/L; 95% confidence interval = -4.5 to 1.0||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Amlodipine+Placebo arms.||||0.2022
73907824|NCT02979197|147345413|SUPERIORITY|||||||0.541|||||||ANCOVA|Adjusted mean = -1.56 μmol/L; 95% confidence interval = -6.6 to 3.5||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Placebo+Placebo arms.||||0.5410
73907825|NCT02979197|147345413|SUPERIORITY|||||||0.9397|||||||ANCOVA|Adjusted mean = 0.19 μmol/L; 95% confidence interval = -4.9 to 5.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Placebo and Placebo+Placebo arms.||||0.9397
73907826|NCT03438383|147345414|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.88||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.88
73907827|NCT03438383|147345414|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.23||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.23
73907828|NCT03438383|147345414|SUPERIORITY|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 hours post-operatively||||0.008
73907829|NCT03438383|147345414|SUPERIORITY|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.001||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.001
73964317|NCT02554786|147464432|SUPERIORITY||LS Mean|2.8|STANDARD_ERROR_OF_MEAN|1.72||0.104|TWO_SIDED|95.0|-0.6|6.2|||LMM|||||6.2|-0.6|0.104
73907830|NCT03438383|147345415|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.75||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.75
73964318|NCT02554786|147464432|SUPERIORITY||LS Mean|3.9|STANDARD_ERROR_OF_MEAN|1.72||0.024|TWO_SIDED|95.0|0.5|7.3|||LMM|||||7.3|0.5|0.024
73964319|NCT02554786|147464432|SUPERIORITY||LS Mean|0.9|STANDARD_ERROR_OF_MEAN|1.73||0.588|TWO_SIDED|95.0|-2.5|4.3|||LMM|||||4.3|-2.5|0.588
73964320|NCT02554786|147464433|SUPERIORITY||LS Mean|6.4|STANDARD_ERROR_OF_MEAN|2.19||0.003|TWO_SIDED|95.0|2.1|10.7|||LMM|||||10.7|2.1|0.003
73964321|NCT02554786|147464433|SUPERIORITY||LS Mean|8.9|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|4.6|13.2|||LMM|||||13.2|4.6|<0.001
73964322|NCT02554786|147464433|SUPERIORITY||LS Mean|4.8|STANDARD_ERROR_OF_MEAN|2.2||0.029|TWO_SIDED|95.0|0.5|9.1|||LMM|||||9.1|0.5|0.029
73964323|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.039||0.001|TWO_SIDED|95.0|-0.2|-0.05|||LMM|||Week1-26 Mean night-time number of puffs||-0.05|-0.2|0.001
73964324|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.08|STANDARD_ERROR_OF_MEAN|0.039||0.035|TWO_SIDED|95.0|-0.16|-0.01|||LMM|||Week 1-26 Mean night-time number of puffs||-0.01|-0.16|0.035
73964325|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.039||0.261|TWO_SIDED|95.0|-0.12|0.03|||LMM|||Week 1-26 Mean night-time number of puffs||0.03|-0.12|0.261
73964326|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|95.0|-0.28|-0.09|||LMM|||Week 1-26 Mean daytime number of puffs||-0.09|-0.28|<0.001
73964327|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.12|STANDARD_ERROR_OF_MEAN|0.047||0.011|TWO_SIDED|95.0|-0.21|-0.03|||LMM|||Week 1-26 Mean daytime number of puffs||-0.03|-0.21|0.011
73964328|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.04|STANDARD_DEVIATION|0.047||0.425|TWO_SIDED|95.0|-0.13|0.06|||LMM|||Week 1-26 Mean daytime number of puffs||0.06|-0.13|0.425
73856732|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73907831|NCT03438383|147345415|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.09||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.09
73907832|NCT03438383|147345415|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 h post-operatively||||0.008
73907833|NCT03438383|147345415|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.013||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.013
73907834|NCT03438383|147345416|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.05||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.05
73856733|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856734|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856735|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856736|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73856737|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73907835|NCT03438383|147345416|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.55||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.55
73907836|NCT03438383|147345416|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.13||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48h post-operatively||||0.13
73964329|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.31|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|-0.46|-0.15|||LMM|||Week 1-26 Mean daily number of puffs||-0.15|-0.46|<0.001
73964330|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.081||0.017|TWO_SIDED|95.0|-0.35|-0.03|||LMM|||Week 1-26 Mean daily number of puffs||-0.03|-0.35|0.017
73964331|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.081||0.29|TWO_SIDED|95.0|-0.24|-0.07|||LMM|||Week 1-26 Mean daily number of puffs||-0.07|-0.24|0.29
73964332|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|0.039||0.004|TWO_SIDED|95.0|-0.19|-0.04|||LMM|||Week 1-52 Mean night-time number of puffs||-0.04|-0.19|0.004
73964333|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.039||0.019|TWO_SIDED|95.0|-0.17|-0.02|||LMM|||Week 1-52 Mean night-time number of puffs||-0.02|-0.17|0.019
73964334|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.039||0.226|TWO_SIDED|95.0|-0.12|0.03|||LMM|||Week 1-52 Mean night-time number of puffs||0.03|-0.12|0.226
73964335|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.17|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.26|-0.07|||LMM|||Week 1-52 Mean daytime number of puffs||-0.07|-0.26|<0.001
73964336|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.048||0.002|TWO_SIDED|95.0|-0.24|-0.05|||LMM|||Week 1-52 Mean daytime number of puffs||-0.05|-0.24|0.002
73964337|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.048||0.384|TWO_SIDED|95.0|-0.14|0.05|||LMM|||Week 1-52 Mean daytime number of puffs||0.05|-0.14|0.384
73964338|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.28|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|-0.44|-0.12|||LMM|||Week 1-52 Mean daily number of puffs||-0.12|-0.44|< 0.001
73964339|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.23|STANDARD_ERROR_OF_MEAN|0.081||0.004|TWO_SIDED|95.0|-0.39|-0.07|||LMM|||Week 1-52 Mean daily number of puffs||-0.07|-0.39|0.004
73964340|NCT02554786|147464434|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.081||0.245|TWO_SIDED|95.0|-0.25|0.06|||LMM|||Week 1-52 Mean daily number of puffs||0.06|-0.25|0.245
73964341|NCT02554786|147464435|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.72|||Regression, Cox|||Moderate or severe asthma exacerbation||0.72|0.39|<0.001
73964342|NCT02554786|147464435|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6|||Regression, Cox|||Moderate or severe asthma exacerbation||0.6|0.34|<0.001
73964343|NCT02554786|147464435|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.209|TWO_SIDED|95.0|0.59|1.12|||Regression, Cox|||Moderate or severe asthma exacerbation||1.12|0.59|0.209
74025884|NCT00892437|147604499|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than in the ATV+RTV+FTC/TDF group; alternative hypothesis: the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95% confidence interval (CI) of the baseline HIV-1 RNA stratum-weighted difference (COBI group - RTV group) in the response rate at Week 24 was greater than -12%.|Difference in percentages|-7.4|||||TWO_SIDED|95.0|-24.6|9.9|||||Difference in percentages of success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|A total planned sample size of 75 subjects had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 84% for both arms and a noninferiority margin of 0.12 were assumed.||9.9|-24.6|
73856738|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73964344|NCT02554786|147464435|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.003|TWO_SIDED|95.0|0.36|0.81|||Regression, Cox|||Severe asthma exacerbation||0.81|0.36|0.003
73856739|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856740|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73964345|NCT02554786|147464435|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.3|0.63|||Regression, Cox|||Severe asthma exacerbation||0.63|0.3|<0.001
73964346|NCT02554786|147464435|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.115|TWO_SIDED|95.0|0.47|1.09|||Regression, Cox|||Severe asthma exacerbation||1.09|0.47|0.115
73964347|NCT02554786|147464435|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.51|0.82|||Regression, Cox|||All asthma exacerbation||0.82|0.51|<0.001
73964348|NCT02554786|147464435|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.38|0.6|||Regression, Cox|||All asthma exacerbation||0.6|0.38|<0.001
73964349|NCT02554786|147464435|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.185|TWO_SIDED|95.0|0.66|1.08|||Regression, Cox|||All asthma exacerbation||1.08|0.66|0.185
73964350|NCT02554786|147464436|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.337|TWO_SIDED|95.0|0.13|2.03|||Regression, Cox|||||2.03|0.13|0.337
73964351|NCT02554786|147464436|SUPERIORITY||Hazard Ratio (HR)|0.14||||0.063|TWO_SIDED|95.0|0.02|1.11|||Regression, Cox|||||1.11|0.02|0.063
73964352|NCT02554786|147464436|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.599|TWO_SIDED|95.0|0.27|9.7|||Regression, Cox|||||9.7|0.27|0.599
73964353|NCT02554786|147464437|SUPERIORITY||Rate Ratio|0.65||||0.008|TWO_SIDED|95.0|0.48|0.89|||Generalized linear model|||Moderate or severe asthma exacerbation||0.89|0.48|0.008
73964354|NCT02554786|147464437|SUPERIORITY||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.35|0.64|||Generalized linear model|||Moderate or severe asthma exacerbation||0.64|0.35|<0.001
73964355|NCT02554786|147464437|SUPERIORITY||Rate Ratio|0.93||||0.669|TWO_SIDED|95.0|0.67|1.29|||Generalized linear model|||Moderate or severe asthma exacerbation||1.29|0.67|0.669
73964356|NCT02554786|147464437|SUPERIORITY||Rate Ratio|0.71||||0.108|TWO_SIDED|95.0|0.47|1.08|||Generalized linear model|||Severe asthma exacerbation||1.08|0.47|0.108
73964357|NCT02554786|147464437|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.31|0.67|||Generalized linear model|||Severe asthma exacerbation||0.67|0.31|<0.001
73964358|NCT02554786|147464437|SUPERIORITY||Rate Ratio|0.89||||0.597|TWO_SIDED|95.0|0.58|1.37|||Generalized linear model|||Severe asthma exacerbation||1.37|0.58|0.597
73964359|NCT02554786|147464437|SUPERIORITY||Rate Ratio|0.67||||0.002|TWO_SIDED|95.0|0.52|0.87|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.87|0.52|0.002
74085145|NCT01186016|147723853|OTHER|Nominal data were analyzed with Chi Square.||||||0.88||||||The a priori threshold P-Value for statistical significance was .05 or less.|Chi-squared|||||||.88
73964360|NCT02554786|147464437|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.36|0.59|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.59|0.36|<0.001
74085146|NCT01098539|147723854|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was from a 1-sided t test to test whether the difference of LS means (albiglutide - sitagliptin) was less than or equal to the prespecified noninferiority margin of 0.4%.|Median Difference (Final Values)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.49|-0.15|||t-test, 1 sided|||||-0.15|-0.49|<0.0001
73856741|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856742|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856743|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73856744|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73856745|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73856746|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856747|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856748|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856749|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856750|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73856751|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73856752|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73856753|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73907837|NCT03438383|147345416|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.011||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.011
73907838|NCT03438383|147345417|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.83||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.83
73907839|NCT03438383|147345417|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.37||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.37
73907840|NCT03438383|147345417|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.0035||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 h post-operatively||||0.0035
73907841|NCT03438383|147345417|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||1.5e-05||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.000015
74085147|NCT00721955|147723870|SUPERIORITY|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
74085148|NCT00721955|147723870|SUPERIORITY|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
74085149|NCT00721955|147723871|SUPERIORITY|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
74085150|NCT00721955|147723871|SUPERIORITY||||||<|0.0001||||||-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
74085151|NCT01589601|147723882|SUPERIORITY||Mean Difference (Net)|4.8719||||0.1641|TWO_SIDED|95.0|-2.0289|11.7728|||Mixed Models Analysis|Baseline||||11.7728|-2.0289|0.1641
73964361|NCT02554786|147464437|SUPERIORITY||Rate Ratio|0.95||||0.681|TWO_SIDED|95.0|0.72|1.23|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||1.23|0.72|0.681
74085152|NCT01589601|147723882|SUPERIORITY|6 Months|Mean Difference (Net)|9.4938||||0.0299|TWO_SIDED|95.0|0.9406|18.047|||Mixed Models Analysis|||||18.0470|0.9406|0.0299
74085153|NCT01589601|147723883|SUPERIORITY||Mean Difference (Net)|2.7157||||0.5531|TWO_SIDED|95.0|-6.3054|11.7368|||Mixed Models Analysis|Baseline||||11.7368|-6.3054|0.5531
74085154|NCT01589601|147723883|SUPERIORITY||Mean Difference (Net)|11.773||||0.035|TWO_SIDED|95.0|0.8409|22.7052|||Mixed Models Analysis|6 Months||||22.7052|0.8409|0.0350
74085155|NCT01589601|147723884|SUPERIORITY|HADS Anxiety 2 weeks|Mean Difference (Net)|-1.2436||||0.1592|TWO_SIDED|95.0|-2.9817|0.4945|||Mixed Models Analysis|||||0.4945|-2.9817|0.1592
74085156|NCT01589601|147723884|SUPERIORITY|HADS Anxiety 3 months|Mean Difference (Net)|-0.7946||||0.3657|TWO_SIDED|95.0|-2.5285|0.9393|||Mixed Models Analysis|||||0.9393|-2.5285|0.3657
74085157|NCT01589601|147723884|SUPERIORITY|HADS Anxiety 6 months|Mean Difference (Net)|-1.8269||||0.048|TWO_SIDED|95.0|-3.6375|-0.0164|||Mixed Models Analysis|||||-0.0164|-3.6375|0.0480
74085158|NCT01589601|147723884|SUPERIORITY|HADS Depression at 2 weeks|Mean Difference (Net)|-0.9097||||0.2372|TWO_SIDED|95.0|-2.4253|0.6058|||Mixed Models Analysis|||||0.6058|-2.4253|0.2372
74085159|NCT01589601|147723884|SUPERIORITY|HADS Depression 3 months|Mean Difference (Net)|-0.6592||||0.4237|TWO_SIDED|95.0|-2.2862|0.9678|||Mixed Models Analysis|||||0.9678|-2.2862|0.4237
74085160|NCT01589601|147723884|SUPERIORITY|HADS Depression at 6 months|Mean Difference (Net)|-1.9379||||0.0202|TWO_SIDED|95.0|-3.5672|-0.3085|||Mixed Models Analysis|||||-0.3085|-3.5672|0.0202
74085161|NCT01589601|147723886|SUPERIORITY|FACIT-Sp at 2 weeks|Mean Difference (Net)|0.9413||||0.5857|TWO_SIDED|95.0|-2.4666|4.3493|||Mixed Models Analysis|||||4.3493|-2.4666|0.5857
74085162|NCT01589601|147723886|SUPERIORITY|FACIT-Sp at 3 months|Mean Difference (Net)|1.1174||||0.5655|TWO_SIDED|95.0|-2.7246|4.9594|||Mixed Models Analysis|||||4.9594|-2.7246|0.5655
74085163|NCT01589601|147723886|SUPERIORITY|FACIT-Sp at 6 months|Mean Difference (Net)|3.9809||||0.0271|TWO_SIDED|95.0|0.4581|7.5036|||Mixed Models Analysis|||||7.5036|0.4581|0.0271
74085164|NCT01589601|147723888|SUPERIORITY|All-cause readmissions, Poisson regression with log link and Pearson scale||||||0.56|||||||Poisson regression|||||||0.56
74085165|NCT01589601|147723888|SUPERIORITY|Cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.8|||||||Poisson regression|||||||0.80
73907842|NCT02766465|147345423|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing severe vaso-occlusive pain (VOC) with hospitalization or parenteral opioid drugs in outpatient setting between two biologically assigned arms during the first year after biologic assignment. The null hypothesis is that there is no difference in biologically assigned arms during the first year after assignment.||||<0.001
73907843|NCT02766465|147345423|SUPERIORITY|||||||0.027||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing significant cerebrovascular event between two biologically assigned arms during the first year after biologic assignment. Significant cerebrovascular event includes stroke, transient ischemic attack, and seizure. The null hypothesis is that there is no difference in biologically assigned arms during the first year after assignment.||||0.027
73907844|NCT02766465|147345423|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing severe Vaso-occlusive pain (VOC) with hospitalization or parenteral opioid drugs in outpatient setting between two biologically assigned arms during the second year after biologic assignment. The null hypothesis is that there is no difference in biologically assigned arms during the second year after assignment.||||< 0.001
73907845|NCT02766465|147345424|SUPERIORITY|||||||0.869||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing 6MWD from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.869
73907846|NCT02766465|147345425|SUPERIORITY|||||||0.636||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing TRJV from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.636
73907847|NCT02766465|147345427|SUPERIORITY|||||||0.242||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Physical Function changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.242
73907848|NCT02766465|147345428|SUPERIORITY|||||||0.343||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Anxiety changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.343
73907849|NCT02766465|147345429|SUPERIORITY|||||||0.491||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Depression changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.491
73907850|NCT02766465|147345430|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing fatigue score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.003
73907851|NCT02766465|147345431|SUPERIORITY|||||||0.594||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Sleep Disturbance changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.594
73907852|NCT02766465|147345432|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing social roles score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.003
73907853|NCT02766465|147345433|SUPERIORITY|||||||0.071||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing pain interference score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.071
73907854|NCT02766465|147345434|SUPERIORITY|||||||0.146||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Pain Intensity changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.146
73907855|NCT02766465|147345435|SUPERIORITY|||||||0.649||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing 28-Day Pain Diary Average Pain Intensity changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.649
73907856|NCT02766465|147345436|SUPERIORITY|||||||0.207||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing ASCQ-Me Stiffness changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.207
73907857|NCT02766465|147345437|SUPERIORITY|||||||0.596||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FEV1 changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.596
74085166|NCT01589601|147723888|SUPERIORITY|Heart failure readmissions, Poisson regression with log link and Pearson scale||||||0.92|||||||Poisson regression|||||||0.92
73907858|NCT02766465|147345438|SUPERIORITY|||||||0.684||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FVC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.684
74085167|NCT01589601|147723888|SUPERIORITY|Non-cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.12|||||||Poisson regression|||||||0.12
73964362|NCT02554786|147464438|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
73964363|NCT02554786|147464438|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
73964364|NCT02554786|147464438|SUPERIORITY|||||||0.059|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.059
74025885|NCT00892437|147604500|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.3|||||TWO_SIDED|95.0|-25.9|9.4|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||9.4|-25.9|
74025886|NCT00892437|147604501|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|-0.02||||0.87|TWO_SIDED|95.0|-0.25|0.22||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in least squares mean (LSM) and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||0.22|-0.25|0.87
73907859|NCT02766465|147345439|SUPERIORITY|||||||0.863||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FEV1/FVC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.863
74025887|NCT00892437|147604502|SUPERIORITY_OR_OTHER||Difference in LSM|-0.03||||0.82|TWO_SIDED|95.0|-0.3|0.23||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||0.23|-0.30|0.82
73907860|NCT02766465|147345440|SUPERIORITY|||||||0.455||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing VC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.455
73907861|NCT02766465|147345441|SUPERIORITY|||||||0.767||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing TLC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.767
74025888|NCT00892437|147604503|SUPERIORITY_OR_OTHER||Difference in LSM|10.0||||0.78|TWO_SIDED|95.0|-63.0|84.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||84|-63|0.78
73907862|NCT02766465|147345442|SUPERIORITY|||||||0.241||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing RV changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.241
74025889|NCT00892437|147604504|SUPERIORITY_OR_OTHER||Difference in LSM|47.0||||0.29|TWO_SIDED|95.0|-41.0|134.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||134|-41|0.29
74025890|NCT01882725|147604518|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
74025891|NCT01882725|147604519|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
73907863|NCT02766465|147345443|SUPERIORITY|||||||0.268||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing ERV changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.268
73907864|NCT02766465|147345444|SUPERIORITY||||||>|0.999||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing IC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||>0.999
73907865|NCT02766465|147345445|SUPERIORITY|||||||0.832||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FRC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.832
73964365|NCT02554786|147464438|SUPERIORITY|||||||0.004|||||||Van Elteren Test|||Severe Asthma Exacerbation||||0.004
73964366|NCT02554786|147464438|SUPERIORITY||||||<|0.001|||||||Van Elteren Test|||Severe Asthma Exacerbation||||<0.001
73964367|NCT02554786|147464438|SUPERIORITY|||||||0.025|||||||van Elteren test|||Severe asthma exacerbation||||0.025
73964368|NCT02554786|147464438|SUPERIORITY|||||||0.002|||||||Van Elteren Test|||All(mild, moderate, severe) Asthma Exacerbation||||0.002
73964369|NCT02554786|147464438|SUPERIORITY||||||<|0.001|||||||Van Elteren Test|||All (mild, moderate, severe) Asthma Exacerbation||||<0.001
73964370|NCT02554786|147464438|SUPERIORITY|||||||0.074|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.074
73964371|NCT02554786|147464440|SUPERIORITY||Hazard Ratio (HR)|0.26||||0.222|TWO_SIDED|95.0|0.03|2.29|||Regression, Cox|||||2.29|0.03|0.222
73964372|NCT02554786|147464440|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.992|TWO_SIDED|95.0|0.0||The upper limit of CI could not be calculated due to low number of participants with asthma exacerbation.||Regression, Cox||||||0|0.992
73964373|NCT02554786|147464440|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.618|TWO_SIDED|95.0|0.05|6.01|||Regression, Cox|||||6.01|0.05|0.618
73964374|NCT02554786|147464443|SUPERIORITY||LS Mean|10.1|STANDARD_ERROR_OF_MEAN|2.02|<|0.001|TWO_SIDED|95.0|6.2|14.1|||LMM|||Weeks 1-26||14.1|6.2|< 0.001
74025892|NCT01238120|147604522|SUPERIORITY|||||||0.9168|||||||ANCOVA|||||||0.9168
74025893|NCT01238120|147604523|SUPERIORITY|||||||0.6536|||||||ANCOVA|||||||0.6536
74025894|NCT02498652|147604557|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||TWO_SIDED|90.0|90.7|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects.||||117|90.7|
73856754|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856755|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856756|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856757|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73856758|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73856759|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73907866|NCT02766465|147345446|SUPERIORITY|||||||0.37||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing DLCO changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.370
73907867|NCT02766465|147345447|SUPERIORITY|||||||0.094||||||Statistical significance was determined using a pre-specified threshold of 0.05;|Wilcoxon (Mann-Whitney)|||This is the result comparing oxygen saturation changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.094
73907868|NCT02766465|147345449|SUPERIORITY|||||||0.313||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade II-IV acute GVHD in patients who received different donor type at transplant||||0.313
73907869|NCT02766465|147345450|SUPERIORITY|||||||0.233||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of chronic GVHD in patients who received different donor type at transplant||||0.233
73907870|NCT02435069|147345458|SUPERIORITY|||||||0.069751||||||significance level set at \<0.05 a priori|two-sample pooled variance t-test|Two-tailed||"Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.~Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%)."||||0.069751
73907871|NCT02435069|147345459|SUPERIORITY|||||||0.172|||||||two-sample pooled variance t-test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.||||0.172
73907872|NCT02435069|147345462|SUPERIORITY|||||||0.8028|||||||two-sample pooled variance t-test|two-sided||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush in the dosing phase of the study.||||0.8028
73907873|NCT02435069|147345463|SUPERIORITY|||||||0.346594|||||||two-sample pooled variance t test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.||||0.346594
73907874|NCT02436681|147345471|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
73907875|NCT02436681|147345473|SUPERIORITY||||||=|0.0468|||||||t-test, 1 sided|||||||= 0.0468
74025895|NCT02498652|147604557|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.6|||||TWO_SIDED|90.0|78.1|110.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects.||||110|78.1|
74025896|NCT02498652|147604557|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||TWO_SIDED|90.0|85.7|120.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||120|85.7|
74085168|NCT03222037|147723918|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|97.5|-0.09|-0.02|||Linear Mixed Model|Linear mixed model with Kenward and Roger method for degrees of freedom|Mean difference was calculated as Test- SCR. This comparison is for high lumniance low contrast|Comparison between the Test and the SCR treatments was carried out using 97.5% confidence intervals for the least-square mean differences.||-0.02|-0.09|
73856760|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856761|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856762|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856763|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856764|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73856765|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73907876|NCT02436681|147345475|SUPERIORITY||||||=|0.014|||||||t-test, 1 sided|||||||=0.014
73907877|NCT02436681|147345476|SUPERIORITY||||||=|0.018|||||||t-test, 1 sided|||||||= 0.018
73907878|NCT01599832|147345488|OTHER|||||||0.083||||||P-value was from test of significance of log-transformed baseline K\^trans.|Regression, Cox|Multivariate model with adjustment for prior treatment, and clinical prognostic index (good/intermediate/poor) (n=16 had complete data)||||||0.083
73907879|NCT01739361|147345509|SUPERIORITY_OR_OTHER|||||||0.353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.353
73907880|NCT04502979|147345512|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.21||0.07|TWO_SIDED|95.0|-0.11|0.73||One-sided p-value for directional hypothesis. The threshold for statistical significance is p \< 0.05.|Mixed Models Analysis|||||0.73|-0.11|0.07
73907881|NCT04502979|147345513|SUPERIORITY||Mean Difference (Net)|-121.16|STANDARD_ERROR_OF_MEAN|65.73||0.04|TWO_SIDED|95.0|-252.73|10.41||One-sided p-value for directional hypothesis. The threshold for statistical significance is p \< 0.05.|Mixed Models Analysis|||||10.41|-252.73|0.04
73907882|NCT02443519|147345519|SUPERIORITY||Slope|1.6||||0.027|TWO_SIDED|95.0|-0.7|3.9||Significance threshold set a priori at .025 to adjust for two co-primary outcomes.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates greater reduction in the proportino of people with Severe MIDAS scores (Score \>=21) in the MBCT-M group vs. the WL/TAU group.|||3.9|-0.7|.027
73907883|NCT02443519|147345520|SUPERIORITY||Slope|14.1|||<|0.004|TWO_SIDED|95.0|0.8|21.8||Significance threshold set a priori at .025 to account for two co-primary outcomes.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|Positive slope indicated larger reductions in HDI in the MBCT-M group compared to the WL/TAU group.|||21.8|0.8|<.004
73907884|NCT02443519|147345521|SUPERIORITY||Slope|-0.05||||0.773|TWO_SIDED|95.0|-3.7|2.8||Threshold for statistical significance set a priori at .05.|Mixed Models Analysis|Key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with Treatment and Time in the model|A positive slope indicates greater reduction in headache days in the MBCT-M group vs. the WL/TAU group.|||2.8|-3.7|.773
73907885|NCT02443519|147345522|SUPERIORITY||Slope|0.01||||0.888|TWO_SIDED|95.0|-0.14|0.16||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in headache attack pain intensity in the MBCT-M group vs. WL/TAU.|||0.16|-0.14|.888
74025897|NCT02498652|147604557|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|88.9|||||TWO_SIDED|90.0|78.4|101.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||101|78.4|
74025898|NCT02498652|147604557|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||TWO_SIDED|90.0|87.7|114.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale||||114|87.7|
74025899|NCT02498652|147604557|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||TWO_SIDED|90.0|85.5|119.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||119|85.5|
74025900|NCT02498652|147604560|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||TWO_SIDED|90.0|94.3|107.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||107|94.3|
74025901|NCT02498652|147604560|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.0|||||TWO_SIDED|90.0|90.4|106.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||106|90.4|
74025902|NCT02498652|147604560|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|104.0|||||TWO_SIDED|90.0|94.5|114.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||114|94.5|
74025903|NCT02498652|147604560|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.0|||||TWO_SIDED|90.0|86.7|97.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||97.7|86.7|
74025904|NCT02498652|147604560|NON_INFERIORITY|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.9|||||TWO_SIDED|90.0|91.0|107.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||107|91.0|
74025905|NCT02498652|147604560|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%|Geometric Least Squares Mean Ratio (%)|97.5|||||TWO_SIDED|90.0|92.8|102.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||102|92.8|
73964375|NCT02554786|147464443|SUPERIORITY||LS Mean|8.3|STANDARD_ERROR_OF_MEAN|2.02|<|0.001|TWO_SIDED|95.0|4.3|12.3|||LMM|||Weeks 1-26||12.3|4.3|<0.001
74025906|NCT01078753|147604568|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.813||||0.009|TWO_SIDED|95.0|0.462|3.163||Desmopressin was considered to be superior to Placebo if the p-value for the comparison was \< 0.05 and the reduction from Baseline in number of wet nights was larger in the FE992026 group than in the Placebo group.|ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||3.163|0.462|0.009
74025907|NCT01078753|147604569|SUPERIORITY_OR_OTHER||Least Squares mean Difference|1.629||||0.018|TWO_SIDED|95.0|0.287|2.972|||ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||2.972|0.287|0.018
74025908|NCT01078753|147604570|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.183||||0.752|TWO_SIDED|95.0|-0.968|1.335|||ANCOVA|Factors in the analysis included Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||1.335|-0.968|0.752
74025909|NCT04334148|147604586|OTHER|||||||0.2|||||||Fisher Exact|||||||0.200
74025910|NCT04334148|147604587|OTHER|||||||1|||||||Regression, Linear|||||||1.0
74025911|NCT04334148|147604588|SUPERIORITY|||||||0.802|||||||Chi-squared|||||||0.802
74025912|NCT01499576|147604607|SUPERIORITY_OR_OTHER||percent agreement|89.2|||||TWO_SIDED|||||||||||||
74025913|NCT01499576|147604608|SUPERIORITY_OR_OTHER||Kappa index of agreement|0.808|||<|0.01|TWO_SIDED||||||Kappa index of agreement|||||||<0.01
73964376|NCT02554786|147464443|SUPERIORITY||LS Mean|4.1|STANDARD_ERROR_OF_MEAN|2.02||0.045|TWO_SIDED|95.0|0.1|8.0|||LMM|||Weeks 1-26||8|0.1|0.045
73964377|NCT02554786|147464443|SUPERIORITY||LS Mean|9.6|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|5.7|13.6|||LMM|||Weeks 1-52||13.6|5.7|<0.001
73964378|NCT02554786|147464443|SUPERIORITY||LS Mean|8.6|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|4.7|12.6|||LMM|||Weeks 1-52||12.6|4.7|<0.001
73964379|NCT02554786|147464443|SUPERIORITY||LS Mean|4.3|STANDARD_ERROR_OF_MEAN|2.04||0.034|TWO_SIDED|95.0|0.3|8.3|||LMM|||Weeks 1-52||8.3|0.3|0.034
74025914|NCT01499576|147604609|SUPERIORITY_OR_OTHER||persent of adverse event|10.48|||||TWO_SIDED|||||||||||||
74025915|NCT04246047|147604628|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|1e-05||95.0|0.31|0.53|||one-sided stratified log-rank||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||0.53|0.31|<0.00001
74025916|NCT05139030|147604675|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL admix and bupivacaine HCI|Mean Difference (Final Values)|-65.8|STANDARD_ERROR_OF_MEAN|26.97||0.0074|TWO_SIDED|95.0|-118.7|-12.9|||ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||The superiority of EXPAREL admixed to bupivacaine HCI was evaluated using the Efficacy Analysis Set.||-12.9|-118.7|0.0074
74025917|NCT05139030|147604676|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL admix and bupivacaine HCI|Mean Ratio|0.77||||0.0018|TWO_SIDED|95.0|0.64|0.92|||ANCOVA|Total opioid consumption was transformed to log scale. Main effect of treatment, covariates: pooled Investigator site (categorical); age (continuous)||The superiority of EXPAREL admixed to bupivacaine HCI was evaluated using the Efficacy Analysis Set.||0.92|0.64|0.0018
74025918|NCT05139030|147604677|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0127|TWO_SIDED|95.0|0.51|0.96|||Cox proportional hazards model|Cox proportional hazard model: treatment as main effect, pooled Investigator site as categorical, and age and height as continuous covariates||||0.96|0.51|0.0127
73856766|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73856767|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856768|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856769|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856770|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856771|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73856772|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73856773|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73856774|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856775|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856776|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856777|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856778|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73856779|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73964380|NCT02554786|147464444|SUPERIORITY||LS Mean|0.147|STANDARD_ERROR_OF_MEAN|0.0462||0.002|TWO_SIDED|95.0|0.056|0.237|||MMRM|||Day 30||0.237|0.056|0.002
73856780|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73856781|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856782|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
74025919|NCT05139030|147604678|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.3674|TWO_SIDED|95.0|-0.6|0.4||Worst pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.4|-0.6|0.3674
74025920|NCT05139030|147604678|SUPERIORITY||Least square mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.1016|TWO_SIDED|95.0|-0.9|0.2||Worst pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.2|-0.9|0.1016
74025921|NCT05139030|147604678|SUPERIORITY||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.34||0.0215|TWO_SIDED|95.0|-1.4|0.0||Worst pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.0|-1.4|0.0215
73856783|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856784|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856785|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73907886|NCT02443519|147345523|SUPERIORITY||Slope|7.45||||0.035|TWO_SIDED|95.0|2.48|12.42|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in Pain Catastrophizing Scale in the MBCT-M group vs. WL/TAU.|||12.42|2.48|.035
73907887|NCT02443519|147345524|SUPERIORITY||Slope|-3.05||||0.572|TWO_SIDED|95.0|-10.83|4.74|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a greater improvement in Chronic Pain Acceptance in the MBCT-M group vs. WL/TAU.|||4.74|-10.83|.572
73907888|NCT02443519|147345525|SUPERIORITY||Slope|-2.65||||0.609|TWO_SIDED|95.0|-11.76|6.46||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a smaller decrease in the Five Factor Mindfulness Questionnaire in the MBCT-M group vs. WL/TAU.|||6.46|-11.76|.609
73907889|NCT02443519|147345526|SUPERIORITY||Slope|8.45||||0.022|TWO_SIDED|95.0|2.99|13.91||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in Headache Specific Locus of Control Scale score in the MBCT-M group vs. WL/TAU.|||13.91|2.99|.022
73907890|NCT02443519|147345527|SUPERIORITY||Slope|-2.01||||0.124|TWO_SIDED|95.0|-7.56|3.53||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a greater improvement in Headache Management Self-Efficacy Scale score in the MBCT-M group vs. WL/TAU.|||3.53|-7.56|.124
73964381|NCT02554786|147464444|SUPERIORITY||LS Mean|0.123|STANDARD_ERROR_OF_MEAN|0.0464||0.008|TWO_SIDED|95.0|0.032|0.214|||MMRM|||Day 30||0.214|0.032|0.008
73964382|NCT02554786|147464444|SUPERIORITY||LS Mean|0.045|STANDARD_ERROR_OF_MEAN|0.046||0.33|TWO_SIDED|95.0|-0.045|0.135|||MMRM|||Day 30||0.135|-0.045|0.33
73964383|NCT02554786|147464444|SUPERIORITY||LS Mean|0.054|STANDARD_ERROR_OF_MEAN|0.0503||0.28|TWO_SIDED|95.0|-0.044|0.153|||MMRM|||Day 86||0.153|-0.044|0.28
73964384|NCT02554786|147464444|SUPERIORITY||LS Mean|0.118|STANDARD_ERROR_OF_MEAN|0.0507||0.02|TWO_SIDED|95.0|0.019|0.217|||MMRM|||Day 86||0.217|0.019|0.02
73964385|NCT02554786|147464444|SUPERIORITY||LS Mean|0.026|STANDARD_ERROR_OF_MEAN|0.0501||0.598|TWO_SIDED|95.0|-0.072|0.125|||MMRM|||Day 86||0.125|-0.072|0.598
73964386|NCT02554786|147464444|SUPERIORITY||LS Mean|0.127|STANDARD_ERROR_OF_MEAN|0.0526||0.016|TWO_SIDED|95.0|0.023|0.23|||MMRM|||Day 183||0.23|0.023|0.016
73964387|NCT02554786|147464444|SUPERIORITY||LS Mean|0.156|STANDARD_ERROR_OF_MEAN|0.0529||0.003|TWO_SIDED|95.0|0.053|0.26|||MMRM|||Day 183||0.26|0.053|0.003
73907891|NCT02443519|147345528|SUPERIORITY||Slope|3.48||||0.017|TWO_SIDED|95.0|0.63|6.33||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in PROMIS-Depression score in the MBCT-M group vs. WL/TAU.|||6.33|0.63|.017
73907892|NCT02443519|147345529|SUPERIORITY||Slope|2.82||||0.259|TWO_SIDED|95.0|-0.03|5.68||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in PROMIS-Anxiety score in the MBCT-M group vs. WL/TAU.|||5.68|-0.03|.259
73907893|NCT02443519|147345530|SUPERIORITY||Slope|-1.0||||0.007|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with both Treatment and Time in the model.|A negative slope indicated a larger decrease in MIDI scores in the MBCT-M group vs. WL/TAU|||-0.3|-1.6|.007
73907894|NCT00932737|147345531|OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0156|TWO_SIDED|95.0|-1.3|-0.1|||Mixed effect model||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.||-0.1|-1.3|0.0156
73907895|NCT00932737|147345532|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0512|TWO_SIDED|95.0|-1.2|0.0|||Mixed effect model||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.||0.0|-1.2|0.0512
73907896|NCT00932737|147345533|OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0351|TWO_SIDED|95.0|-1.3|0.0|||ANCOVA||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.||0.0|-1.3|0.0351
73907897|NCT00932737|147345534|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3557|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA||The adjusted mean difference between Hyoscine butylbromide and Placebo was calculated.|The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.||0.4|-1.0|0.3557
73907898|NCT00932737|147345535|OTHER||Odds Ratio (OR)|1.071||||0.831|TWO_SIDED|95.0|0.572|2.004|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.004|0.572|0.831
73907899|NCT00932737|147345536|OTHER||Odds Ratio (OR)|1.222||||0.557|TWO_SIDED|95.0|0.626|2.387|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.387|0.626|0.557
73907900|NCT00932737|147345537|OTHER||Odds Ratio (OR)|0.737||||0.396|TWO_SIDED|95.0|0.365|1.49|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||1.490|0.365|0.396
73907901|NCT00932737|147345538|OTHER||Odds Ratio (OR)|1.336||||0.448|TWO_SIDED|95.0|0.632|2.827|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.827|0.632|0.448
73907902|NCT00932737|147345539|OTHER||Odds Ratio (OR)|2.474||||0.03|TWO_SIDED|95.0|1.093|5.604|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||5.604|1.093|0.030
73907903|NCT00932737|147345540|OTHER||Odds Ratio (OR)|1.654||||0.167|TWO_SIDED|95.0|0.81|3.378|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||3.378|0.810|0.167
73907904|NCT00932737|147345541|OTHER|||||||0.256|||||||Log Rank|Log rank test was used for comparison of Hyoscine butylbromide (Buscopan®) 20 mg group versus Placebo group.||||||0.2560
73907905|NCT00932737|147345542|OTHER|||||||0.5179|||||||Log Rank|Log rank test was used for comparison of Hyoscine butylbromide (Buscopan®) 20 mg group versus Placebo group.||||||0.5179
73907906|NCT01881373|147345552|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-3.88||||0.02|TWO_SIDED|95.0|-7.29|-0.47|||Regression, Logistic|Hierarchical model.|Intervention vs control communities comparing 24 months to baseline|||-0.47|-7.29|0.02
73907907|NCT01881373|147345552|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-2.63||||0.28|TWO_SIDED|95.0|-8.58|3.32||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||3.32|-8.58|0.28
73907908|NCT01881373|147345553|SUPERIORITY|Hierarchical model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.64||||0.009|TWO_SIDED|95.0|-2.87|-0.41||Intervention vs control communities comparing 78 months to baseline.|Regression, Linear|Hierarchical model.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-0.41|-2.87|0.009
73964388|NCT02554786|147464444|SUPERIORITY||LS Mean|0.085|STANDARD_ERROR_OF_MEAN|0.0525||0.103|TWO_SIDED|95.0|-0.017|0.188|||MMRM|||Day 183||0.188|-0.017|0.103
74025922|NCT05139030|147604678|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.34||0.0794|TWO_SIDED|95.0|-1.2|0.2||Worst pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.2|-1.2|0.0794
74025923|NCT05139030|147604678|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.29||0.3606|TWO_SIDED|95.0|-0.7|0.5||Average pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.5|-0.7|0.3606
74025924|NCT05139030|147604678|SUPERIORITY||Least square mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0184|TWO_SIDED|95.0|-1.1|0.0||Average pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.0|-1.1|0.0184
73856786|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73856787|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73856788|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73907909|NCT01881373|147345553|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|4.35||||0.49|TWO_SIDED|95.0|-8.5|17.24|||Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs temporal comparing 78 months to baseline.||17.24|-8.5|0.49
73907910|NCT01881373|147345554|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Difference in prevalence|-3.6|||<|0.01|TWO_SIDED||||||Regression, Logistic|Hierarchical model||Intervention vs control comparing 24 months to baseline.||||<0.01
73907911|NCT01881373|147345555|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|change in prevalence between communities|-12.6||||0.003|TWO_SIDED|95.0|-20.92|-4.28||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-4.28|-20.92|0.003
73930941|NCT00280566|147391710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.78||0.2116|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2116
74025925|NCT05139030|147604678|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0476|TWO_SIDED|95.0|-1.1|0.1||Average pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.1|-1.1|0.0476
74025926|NCT05139030|147604678|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0529|TWO_SIDED|95.0|-1.1|0.1||Average pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.1|-1.1|0.0529
74025927|NCT03772327|147604700|SUPERIORITY||Mean Difference (Net)|0.333||||0.07|TWO_SIDED|95.0|-0.028|0.694|||t-test, 2 sided|A ratio of Week 12 to baseline TFV-DP levels was used rather than a raw difference as a ratio was normally distributed.|The mean difference is mean ratio (Week 12 TFV-DP level over the Week 0 TFV-DP level) in the Routine counseling + AdhereTech bottle arm less the mean ratio in the Routine counseling arm.|The power calculation was based on a null hypothesis of no difference in mean tenofovir-diphosphate (TFV-DP) concentrations between baseline versus week 12. Expected baseline mean (SD): 900 (404) fmol/punch. 12 week mean (SD): 1332 (597) fmol/punch in the AdhereTech bottle arm vs. 900 (404) fmol/punch in control arm. Type 1 error = 0.05, power = 80%, a sample size of 32 per arm (64 total) based on a two-sided t-test with equal variance.||0.694|-0.028|0.070
74025928|NCT03772327|147604701|EQUIVALENCE|Equivalence defined if a two-sided 2 sample proportion test accepts the null hypothesis with p \> 0.05.|Difference in proportions|0.045||||0.89|TWO_SIDED|95.0|-0.179|0.27|||Chi-squared, Corrected|degrees of freedom = 1|This is the proportion of those completing a week 12 visit less those completing a week 0 visit.|The null hypothesis is that the proportion of randomized participants that complete a week 12 visit is not lower in the AdhereTech bottle arm.||0.270|-0.179|0.89
74025929|NCT03772327|147604702|SUPERIORITY||Median Difference (Net)|-0.07||||0.328|TWO_SIDED||||||Kruskal-Wallis|Log transformation of viral load|Difference of log viral load at Week 12 less the log viral load at baseline|Null hypothesis: Mean HIV viral load is not significantly different in the AdhereTech bottle group compared to the routine counseling only group.||||0.328
74025930|NCT03772327|147604703|SUPERIORITY||Odds Ratio (OR)|0.395||||0.294|TWO_SIDED|95.0|0.058|2.044|||Fisher Exact||Odds ratio for change from HIV RNA ≥ 20 copies/mL at baseline to HIV RNA \< 20 copies/mL at week 12 due to the intervention (AdhereTech bottle).|Null hypothesis: There is no difference in proportion of participants that go from HIV RNA ≥ 20 copies/mL to HIV RNA \< 20 copies/mL between baseline to Week 12 in the AdhereTech bottle group compared the routine counseling group.||2.044|0.058|0.294
73856789|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856790|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856791|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
73856792|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
73856793|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
73856794|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
73856795|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
73856796|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
73856797|NCT01559259|147258990|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
73856798|NCT01559259|147258991|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||<|0.001|TWO_SIDED|95.0|0.17|0.45||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.45|0.17|<0.001
73856799|NCT01559259|147258991|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.39||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.39|0.15|<0.001
73856800|NCT01559259|147258991|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.35||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.35|0.13|<0.001
73930942|NCT00280566|147391710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.68||0.1847|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1847
73856801|NCT01559259|147258991|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.25|||<|0.001|TWO_SIDED|95.0|0.15|0.41||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 400 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.41|0.15|<0.001
73856802|NCT01559259|147258991|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.12||||0.549|TWO_SIDED|95.0|0.77|1.63||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.63|0.77|0.549
73856803|NCT01559259|147258991|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.863|TWO_SIDED|95.0|0.66|1.42||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.42|0.66|0.863
73856804|NCT01559259|147258991|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.86||||0.454|TWO_SIDED|95.0|0.57|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.28|0.57|0.454
73856805|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-41.07|||<|0.001|TWO_SIDED|95.0|-59.56|-22.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.58|-59.56|<0.001
73856806|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-40.98|||<|0.001|TWO_SIDED|95.0|-59.41|-22.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.56|-59.41|<0.001
73856807|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-38.64|||<|0.001|TWO_SIDED|95.0|-57.49|-19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-19.79|-57.49|<0.001
73856808|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-38.11|||<|0.001|TWO_SIDED|95.0|-56.94|-19.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-19.28|-56.94|<0.001
73856809|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.13||||0.274|TWO_SIDED|95.0|-8.67|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.40|-8.67|0.274
73856810|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.89||||0.304|TWO_SIDED|95.0|-8.4|2.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.62|-8.40|0.304
73964389|NCT02554786|147464444|SUPERIORITY||LS Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0542||0.188|TWO_SIDED|95.0|-0.035|0.178|||MMRM|||Day 254||0.178|-0.035|0.188
73964390|NCT02554786|147464444|SUPERIORITY||LS Mean|0.168|STANDARD_ERROR_OF_MEAN|0.0543||0.002|TWO_SIDED|95.0|0.061|0.274|||MMRM|||Day 254||0.274|0.061|0.002
73964391|NCT02554786|147464444|SUPERIORITY||LS Mean|0.061|STANDARD_ERROR_OF_MEAN|0.0538||0.258|TWO_SIDED|95.0|-0.045|0.166|||MMRM|||Day 254||0.166|-0.045|0.258
73964392|NCT02554786|147464444|SUPERIORITY||LS Mean|0.079|STANDARD_ERROR_OF_MEAN|0.0552||0.154|TWO_SIDED|95.0|-0.03|0.187|||MMRM|||Day 364||0.187|-0.030|0.154
73964393|NCT02554786|147464444|SUPERIORITY||LS Mean|0.191|STANDARD_ERROR_OF_MEAN|0.0553|<|0.001|TWO_SIDED|95.0|0.082|0.299|||MMRM|||Day 364||0.299|0.082|<0.001
73964394|NCT02554786|147464444|SUPERIORITY||LS Mean|0.041|STANDARD_ERROR_OF_MEAN|0.0548||0.455|TWO_SIDED|95.0|-0.067|0.148|||MMRM|||Day 364||0.148|-0.067|0.455
73964395|NCT02554786|147464445|NON_INFERIORITY|QMF 150/320 was considered non-inferior to S/F 50/500 if the lower bound of the 95% CI was above the non-inferiority margin of -90 mL and was considered superior if the lower bound of the 95% CI was \> 0. The p-value is for null-hypothesis testing.|LS Mean|0.036|STANDARD_ERROR_OF_MEAN|0.0222||0.101|TWO_SIDED|95.0|-0.007|0.08|||MMRM|||||0.080|-0.007|0.101
73964396|NCT00539734|147464451|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Comparing pre-operative data with postoperative data in terms of changes in amplitude height and implicit time.||||<0.05
73964397|NCT04515641|147464454|OTHER||GMR|0.75|||||TWO_SIDED|90.0|0.58|0.96|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.96|0.58|
73856811|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.96||||0.769|TWO_SIDED|95.0|-7.41|5.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.49|-7.41|0.769
73856812|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.19|||<|0.001|TWO_SIDED|95.0|-88.0|-54.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-54.38|-88.00|<0.001
73856813|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-66.99|||<|0.001|TWO_SIDED|95.0|-84.26|-49.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.72|-84.26|<0.001
73856814|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-67.47|||<|0.001|TWO_SIDED|95.0|-84.75|-50.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-50.19|-84.75|<0.001
73856815|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.76|||<|0.001|TWO_SIDED|95.0|-80.45|-45.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-45.07|-80.45|<0.001
73856816|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-8.53||||0.021|TWO_SIDED|95.0|-15.55|-1.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-1.50|-15.55|0.021
73856817|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.99||||0.337|TWO_SIDED|95.0|-12.05|4.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.07|-12.05|0.337
73856818|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.26||||0.204|TWO_SIDED|95.0|-13.28|2.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.76|-13.28|0.204
73856819|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-77.89|||<|0.001|TWO_SIDED|95.0|-92.29|-63.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-63.49|-92.29|<0.001
73856820|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.65|||<|0.001|TWO_SIDED|95.0|-86.71|-56.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.58|-86.71|<0.001
73856821|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-72.87|||<|0.001|TWO_SIDED|95.0|-88.06|-57.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-57.68|-88.06|<0.001
73856822|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-67.2|||<|0.001|TWO_SIDED|95.0|-82.87|-51.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-51.52|-82.87|<0.001
74025931|NCT03772327|147604705|SUPERIORITY||Difference in proportions|0.019||||1|TWO_SIDED|95.0|-0.237|0.276|||Chi-squared, Corrected|||Null hypothesis: Adherence in the AdhereTech bottle arm is not better than the control arm at Week 12.||0.276|-0.237|1
74025932|NCT00397150|147604749|SUPERIORITY_OR_OTHER||Prevalence ratio|2.29|||||TWO_SIDED|95.0|1.33|3.92||||||||3.92|1.33|
74025933|NCT00397150|147604754|SUPERIORITY_OR_OTHER||Prevalence ratio|1.89|||||TWO_SIDED|95.0|1.7|2.11||||||||2.11|1.70|
73856823|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-10.71||||0.007|TWO_SIDED|95.0|-18.2|-3.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-3.21|-18.20|0.007
74025934|NCT00397150|147604755|SUPERIORITY_OR_OTHER||Prevalence ratio|1.72|||||TWO_SIDED|95.0|1.12|2.63||||||||2.63|1.12|
73907912|NCT01881373|147345555|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-3.43||||0.33|TWO_SIDED|95.0|-10.36|3.5||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs. Temporal communities. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||3.50|-10.36|0.33
73907913|NCT01881373|147345556|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-0.71||||0.02|TWO_SIDED|95.0|-1.37|-0.05||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-0.05|-1.37|0.02
73907914|NCT01881373|147345556|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-0.65||||0.13|TWO_SIDED|95.0|-1.79|0.49||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||0.49|-1.79|0.13
73907915|NCT01881373|147345557|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.01||||0.86|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.86
73907916|NCT01881373|147345558|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.17||||0.68|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.68
73907917|NCT01881373|147345559|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|3.42||||0.55|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.55
73907918|NCT01881373|147345560|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.5||||0.11|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.11
73907919|NCT01881373|147345561|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.7||||0.08|TWO_SIDED||||||Regression, Linear|||mixed model adjusting for age and sex and cluster of community and strata of jurisdiction; intervention vs control comparing 24 months to baseline||||0.08
73964398|NCT04515641|147464455|OTHER||GMR|0.75|||||TWO_SIDED|90.0|0.58|0.98|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.98|0.58|
74025935|NCT05300087|147604787|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for Cmax between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.014|||<|0.0001|TWO_SIDED|90.0|0.947|1.085|||ANOVA|||||1.085|0.947|<0.0001
73907920|NCT01881373|147345562|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.04||||0.71|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.71
73907921|NCT01881373|147345563|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.02||||0.54|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.54
73907922|NCT01881373|147345564|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.01||||0.9|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.90
73964399|NCT04515641|147464456|OTHER||GMR|0.65|||||TWO_SIDED|90.0|0.38|1.14|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.14|0.38|
74025936|NCT05300087|147604788|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for AUC(0-t) between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.022|||<|0.0001|TWO_SIDED|90.0|0.993|1.051|||ANOVA|||||1.051|0.993|<0.0001
73907923|NCT01881373|147345565|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.05||||0.71|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.71
73907924|NCT01881373|147345566|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.18||||0.48|TWO_SIDED|||||intervention vs control communities|Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.48
73907925|NCT01881373|147345567|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|differences in prevalence|-3.6|||<|0.01|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|Hierarchical model||intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||<0.01
73907926|NCT01881373|147345568|SUPERIORITY|Hierarchical|Mean Difference (Final Values)|0.09||||0.44|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.44
73907927|NCT01881373|147345569|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.16||||0.81|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs. Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.81
73907928|NCT01881373|147345570|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.37||||0.68|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.68
74025937|NCT05300087|147604789|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for AUC(0-inf) between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.021|||<|0.0001|TWO_SIDED|90.0|0.994|1.048|||ANOVA|||||1.048|0.994|<0.0001
74025938|NCT01450137|147604813|SUPERIORITY||Risk Difference (RD)|0.45||||0.0301|TWO_SIDED|95.0|0.11|0.79|||Fisher Exact|||||0.79|0.11|0.0301
73930943|NCT00280566|147391710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.82||0.9972|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9972
73930944|NCT00280566|147391711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.93||0.5954|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5954
73930945|NCT00280566|147391711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.93||0.3414|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3414
73930946|NCT00280566|147391711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|1.23||0.9745|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate||||0.9745
73930947|NCT00280566|147391711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.47||0.5627|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5627
73930948|NCT00280566|147391711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|1.1||0.741|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7410
73907929|NCT01881373|147345571|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.02||||0.69|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.69
73907930|NCT01881373|147345572|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.21||||0.11|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.11
73907931|NCT01881373|147345573|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.06||||0.4|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|||Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.40
73907932|NCT01881373|147345574|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.2||||0.37|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.37
73907933|NCT01881373|147345574|SUPERIORITY|Hierarchical model.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.18||||0.51|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs temporal.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.51
73907934|NCT04399837|147345593|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.041||||0.002|||||||MCP-Mod linear model fit|Model assumption: Dose effect is linear with the increase of dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
73907935|NCT04399837|147345593|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.033||||0.002|||||||MCP-Mod Emax2 model fit|Model assumption: 95% of the maximum effect is achieved at low dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
74025939|NCT01450137|147604814|SUPERIORITY||Risk Difference (RD)|0.65||||0.001|TWO_SIDED|95.0|0.36|0.94|||Fisher Exact|||||0.94|0.36|0.0010
74085169|NCT03222037|147723918|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05|Median Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|97.5|-0.06|-0.01|||Linear Mixed Model|Linear mixed model with Kenward and Roger method for denominator degrees of freedom|Mean difference was calculated as Test- SCR. This comparison is for Low luminance high contrast|||-0.01|-0.06|
73907936|NCT04399837|147345593|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.088||||0.002|||||||MCP-Mod Emax1 model fit|Model assumption: 70% of the maximum effect is achieved at low dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
74025940|NCT01450137|147604815|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
74025941|NCT01450137|147604816|SUPERIORITY||Mean Difference (Final Values)|25.0||||0.0005|TWO_SIDED|95.0|11.0|39.0|||z-test||Difference between restricted mean survival time at 12 months|||39|11|0.0005
74025942|NCT01477450|147604826|SUPERIORITY_OR_OTHER|||||||0.3|||||||Chi-squared|||||||0.3
74025943|NCT01477450|147604826|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||||||0.47
74025944|NCT01477450|147604826|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
74025945|NCT03478683|147604891|NON_INFERIORITY|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.015|STANDARD_ERROR_OF_MEAN|0.0143|||TWO_SIDED|95.0|-0.013|0.043|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.|||0.043|-0.013|
73907937|NCT04399837|147345593|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|2.977||||0.003|||||||MCP-Mod exponential model fit|Model assumption: 35% of the maximum effect is achieved at medium dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.003
73907938|NCT04399837|147345593|SUPERIORITY|Null hypothesis: Effect of spesolimab 300 mg every 12 weeks on prolonging the time to the first GPP flare up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.468||||0.0269|TWO_SIDED|95.0|0.206|1.064||"One-sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~Threshold for statistical significance: one-sided p-value ≤ 0.01875."|Log Rank||Hazard ratio and its 95% Confidence Interval are from Cox regression model stratified by use of systemic GPP medication at randomisation.|||1.064|0.206|0.0269
73907939|NCT04399837|147345593|SUPERIORITY|Null hypothesis: Effect of spesolimab 300 mg every 4 weeks on prolonging the time to the first GPP flare up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.157||||0.0005|TWO_SIDED|95.0|0.046|0.541||"One-sided p-value is computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~Threshold for statistical significance: One-sided p-value ≤0.0125."|Log Rank||Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.|||0.541|0.046|0.0005
73907940|NCT04399837|147345594|SUPERIORITY|Null hypothesis: The proportion of patients who do not experience a GPP flare up to week 48 on BI 655130 300 mg every 4 weeks ≤ Placebo.|Risk Difference (RD)|-0.39||||0.0013|TWO_SIDED|95.0|-0.621|-0.159||"One-sided p-value was computed from the Cochran-Mantel-Haenszel test stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"|Cochran-Mantel-Haenszel||Risk difference=Spesolimab high dose-Placebo.|||-0.159|-0.621|0.0013
73907941|NCT04399837|147345595|SUPERIORITY|Null hypothesis: Effect of BI 655130 300 mg every 4 weeks on prolonging the time to first worsening of PSS up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.424||||0.0134|TWO_SIDED|95.0|0.197|0.914||"One-sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"|Log Rank||spesolimab high dose vs. Placebo|Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.||0.914|0.197|0.0134
73964400|NCT04515641|147464463|OTHER||GMR|0.76|||||TWO_SIDED|90.0|0.57|1.0|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.00|0.57|
74085170|NCT03222037|147723919|EQUIVALENCE|Statistical significance is declared if the lower limit of the 95% confidence interval is above 0 or if the upper limit of the 95% confidence interval is below 0.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0066|TWO_SIDED|95.0|0.01|0.08|||Linear Mixed Model|Linear Mixed Model with Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - SCR.|Comparison between the Test and SCR treatments was carried out using least-square mean differences||0.08|0.01|0.0066
74085171|NCT00496262|147723920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.9|STANDARD_DEVIATION|4.4|<|0.0001||90.0|||||2-sided, 1-sample t-test||The entire ITT population was used for a conservative analysis of the mean change in MCF. The mean change was set to 0 for any subject with missing MCF data.|This is an open-label study with statistical comparison between MCF pre-infusion and 1 hour post-infusion.||||<0.0001
73907942|NCT04399837|147345596|SUPERIORITY|Null hypothesis: Effect of BI 655130 300 mg every 4 weeks on prolonging the time to the first worsening of DLQI up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.259||||0.001|TWO_SIDED|95.0|0.109|0.62||One sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.|Log Rank||spesolimab high dose vs. Placebo|"Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"||0.620|0.109|0.0010
73907943|NCT01532973|147345599|SUPERIORITY_OR_OTHER||Difference in LS Means|4.26|||||TWO_SIDED|90.0|3.77|4.74||||||||4.74|3.77|
73907944|NCT01532973|147345599|SUPERIORITY_OR_OTHER||Difference in LS Means|4.41|||||TWO_SIDED|90.0|3.92|4.9||||||||4.90|3.92|
73907945|NCT01532973|147345599|SUPERIORITY_OR_OTHER||Difference in LS Means|3.56|||||TWO_SIDED|90.0|3.08|4.05||||||||4.05|3.08|
73907946|NCT01532973|147345600|SUPERIORITY_OR_OTHER||Difference in LS Means|1.02|||||TWO_SIDED|90.0|0.34|1.69||||||||1.69|0.34|
73907947|NCT01532973|147345600|SUPERIORITY_OR_OTHER||Difference in LS Means|2.07|||||TWO_SIDED|90.0|1.39|2.74||||||||2.74|1.39|
73907948|NCT01532973|147345600|SUPERIORITY_OR_OTHER||Difference in LS Means|2.72|||||TWO_SIDED|90.0|2.05|3.39||||||||3.39|2.05|
73907949|NCT01532973|147345601|SUPERIORITY_OR_OTHER||Difference in LS Means|3.2|||||TWO_SIDED|90.0|2.68|3.72||||||||3.72|2.68|
73907950|NCT01532973|147345601|SUPERIORITY_OR_OTHER||Difference in LS Means|3.95|||||TWO_SIDED|90.0|3.44|4.47||||||||4.47|3.44|
73907951|NCT01532973|147345602|SUPERIORITY_OR_OTHER||Difference in LS Means|3.89|||||TWO_SIDED|90.0|3.2|4.58||||||||4.58|3.20|
73907952|NCT01532973|147345602|SUPERIORITY_OR_OTHER||Difference in LS Means|4.67|||||TWO_SIDED|90.0|3.98|5.36||||||||5.36|3.98|
73907953|NCT01532973|147345602|SUPERIORITY_OR_OTHER||Difference in LS Means|3.61|||||TWO_SIDED|90.0|2.92|4.3||||||||4.30|2.92|
73907954|NCT01532973|147345603|SUPERIORITY_OR_OTHER||Difference in LS Means|0.72|||||TWO_SIDED|90.0|-0.09|1.54||||||||1.54|-0.09|
73907955|NCT01532973|147345603|SUPERIORITY_OR_OTHER||Difference in LS Means|2.57|||||TWO_SIDED|90.0|1.75|3.39||||||||3.39|1.75|
73907956|NCT01532973|147345603|SUPERIORITY_OR_OTHER||Difference in LS Means|2.84|||||TWO_SIDED|90.0|2.02|3.66||||||||3.66|2.02|
73907957|NCT01532973|147345604|SUPERIORITY_OR_OTHER||Difference in LS Means|3.17|||||TWO_SIDED|90.0|2.55|3.8||||||||3.80|2.55|
73907958|NCT01532973|147345604|SUPERIORITY_OR_OTHER||Difference in LS Means|3.63|||||TWO_SIDED|90.0|3.0|4.26||||||||4.26|3.00|
74085172|NCT04511208|147723963|SUPERIORITY||Difference in means|-2.2|||<|0.001|TWO_SIDED|95.0|-2.7|-1.7|||Repeated measures linear model|||||-1.7|-2.7|<0.001
74085173|NCT04511208|147723964|SUPERIORITY||Difference in means|-0.26||||0.006|TWO_SIDED|95.0|-0.44|-0.08|||Repeated measures linear model|||||-0.08|-0.44|0.006
73907959|NCT03950791|147345643|SUPERIORITY||Mann-Whitney U|3864.0|STANDARD_ERROR_OF_MEAN|302.0||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons, p \< .05 used as threshold for statistical significance|Independent-samples Mann-Whitney U|No adjustments for multiple comparisons|Standardized Test Statistic = .139|Morphine equivalent dosage outcome variables were not normally distributed (skewness values between 4.5 and 4.8, kurtosis values between 25.7 and 30.0), which necessitated non-parametric analysis using independent-samples Mann-Whitney U Test||||.89
73907960|NCT02719327|147345644|SUPERIORITY||Slope|-2.18||||0.17|TWO_SIDED|95.0|-5.36|0.99||ASL values at 18 months were regressed on treatment group (IPE vs placebo) statistically controlling for age at baseline visit and ASL measured at baseline visit.|Regression, Linear|||The proposed study aims to investigate the effects of 18 months of IPE vs. placebo on regional cerebral blood flow in the bilateral posterior cingulate gyrus as measured by arterial spin-labeling MRI . IPE was hypothesized to improve regional cerebral blood flow over placebo after 18 months.||0.99|-5.36|0.17
73907961|NCT02719327|147345645|SUPERIORITY||Slope|0.11||||0.12|TWO_SIDED|95.0|-0.04|0.25|||Regression, Linear|18 month Beta-amyloid(1-42) was regressed on group (IPE vs placebo) and covariates age at baseline visit and Beta-amyloid(1-42) at baseline visit.|Placebo group is the reference group.|Beta-amyloid(1-42) concentration in CSF was log-transformed prior to analysis to approximate a normal distribution.||0.25|-0.04|.12
73907962|NCT02719327|147345645|SUPERIORITY||Slope|0.045||||0.05|TWO_SIDED|95.0|0.004|0.061|||Regression, Linear|log-transformed 18 month pTau181 was regressed on group (IPE vs placebo) and covariates age at baseline and log-transformed ptau181at baseline visit.|Placebo group is the reference group.|Phosphorylated tau (pTau181) measured in CSF was log-transformed prior to analysis to approximate a normal distribution.||0.061|0.004|0.05
73907963|NCT02719327|147345645|SUPERIORITY||Slope|0.046||||0.07|TWO_SIDED|95.0|-0.0008|0.106||18 months total Tau was regressed on Group (IPE vs placebo) and covariates age at baseline and total Tau at baseline.|Regression, Linear||Placebo group was the reference group.|Total tau was log-transformed prior to analysis to better approximate a normal distribution.||0.106|-0.0008|.07
73907964|NCT02719327|147345646|SUPERIORITY||Slope|0.006||||0.48|TWO_SIDED|95.0|-0.009|0.023|||Linear Mixed Effects model|Covariates included education level, gender, and age at baseline visit.|Placebo group was the reference group.|Four cognitive tests were standardized (baseline mean and standard deviation) prior to averaging to create the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) score. The final composite score was standardized again using baseline mean and standard deviation (range -3.15 to 3.10). Higher scores indicate better cognitive performance. A linear mixed effects model was used to determine if change in ADCS-PACC composite scores was modified by treatment group.||0.023|-0.009|.48
73907965|NCT01470859|147345649|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed on the changes of PDRP Z score between levodopa and pramipexole groups.||||||0.84
73907966|NCT01470859|147345649|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V1||||||0.93
73907967|NCT01470859|147345649|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V5||||||0.31
73907968|NCT01470859|147345650|SUPERIORITY_OR_OTHER|||||||0.691|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V1 scores between the levodopa and pramipexole groups||||||0.691
73907969|NCT01470859|147345650|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V2 scores between the levodopa and pramipexole groups||||||0.706
73907970|NCT01470859|147345650|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V5 scores between the levodopa and pramipexole groups||||||0.635
73907971|NCT01470859|147345650|SUPERIORITY_OR_OTHER|||||||0.341|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V1 scores between the levodopa and pramipexole groups||||||0.341
73907972|NCT01470859|147345650|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V2 scores between the levodopa and pramipexole groups||||||0.049
73907973|NCT01470859|147345650|SUPERIORITY_OR_OTHER|||||||0.874|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V5 scores between the levodopa and pramipexole groups||||||0.874
73907974|NCT01470859|147345651|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V1||||||0.720
73907975|NCT01470859|147345651|SUPERIORITY_OR_OTHER|||||||0.867|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V5||||||0.867
73907976|NCT01470859|147345652|SUPERIORITY_OR_OTHER|||||||0.793|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|indenpendent U test|independent U test The statistical analysis was performed to compare the H\&Y stages between levodopa and pramipexole group at V1||||||0.793
73907977|NCT01470859|147345652|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the H\&Y stages between levodopa and pramipexole groups at V5||||||0.430
74085174|NCT04511208|147723965|SUPERIORITY||Difference in means|-0.23||||0.046|TWO_SIDED|95.0|-0.45|-0.005|||Repeated measures linear model|||||-0.005|-0.45|0.046
73907978|NCT01470859|147345653|SUPERIORITY_OR_OTHER|||||||0.345|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V2||||||0.345
73907979|NCT01470859|147345653|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V5||||||0.410
73907980|NCT05268055|147345662|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||Group comparison of all participants.||||0.525
74025946|NCT03478683|147604892|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.0139||0.481|TWO_SIDED|95.0|-0.037|0.018||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2|||0.018|-0.037|0.481
74025947|NCT03478683|147604892|SUPERIORITY||Mean Difference (Net)|0.061|STANDARD_ERROR_OF_MEAN|0.0124|<|0.001|TWO_SIDED|95.0|0.037|0.086||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28|||0.086|0.037|<0.001
73907981|NCT05268055|147345662|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.045
73907982|NCT05268055|147345662|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.046
73907983|NCT05268055|147345663|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Group comparison of all participants.||||0.200
73907984|NCT05268055|147345663|SUPERIORITY|||||||0.075|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.075
73907985|NCT05268055|147345663|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.015
73907986|NCT05268055|147345664|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||Group comparison of all participants.||||0.246
73907987|NCT05268055|147345664|SUPERIORITY|||||||0.151|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.151
73907988|NCT05268055|147345664|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.033
73907989|NCT05268055|147345665|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||Group comparison of all participants.||||0.212
74025948|NCT03478683|147604892|SUPERIORITY||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.0133|<|0.001|TWO_SIDED|95.0|0.032|0.084||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84|||0.084|0.032|<0.001
74085175|NCT04511208|147723966|SUPERIORITY||Difference in means|-0.07||||0.955|TWO_SIDED|95.0|-2.51|2.38|||Repeated measures linear model|||C3B PST Score||2.38|-2.51|0.955
73907990|NCT05268055|147345665|SUPERIORITY|||||||0.893|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.893
73907991|NCT05268055|147345665|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.160
73907992|NCT05268055|147345666|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Healthcare Provider Cultural Competence measure.||||0.752
73907993|NCT05268055|147345666|SUPERIORITY|||||||0.493|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Ask, Understand, Remember Assessment.||||0.493
73907994|NCT05268055|147345666|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Wake Forest Physician Trust Scale.||||0.085
73907995|NCT01854658|147345679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
73907996|NCT01854658|147345679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
73907997|NCT01854658|147345679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
73907998|NCT01854658|147345679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
73907999|NCT01854658|147345679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
73908000|NCT01854658|147345679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
73908001|NCT02203071|147345684|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
73908002|NCT02203071|147345685|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
73908003|NCT02203071|147345686|SUPERIORITY||||||>|0.11|||||||t-test, 2 sided|||||||>0.11
73908004|NCT02203071|147345687|SUPERIORITY||||||<|0.007|||||||ANOVA|||||||<0.007
73908005|NCT02203071|147345688|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73908006|NCT02203071|147345689|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73908007|NCT03894046|147345690|NON_INFERIORITY|"Non-inferiority was concluded if the upper limit of the 2-sided 95% CI was less than +20%.~Superiority was concluded if the upper limit of the 2-sided 95% CI was less than 0."|Mean Difference (Final Values)|-13.2|||||TWO_SIDED|95.0|-30.0|3.5||||||The non-inferiority assessment was based on the 2-sided 95% CIs computed using a continuity-corrected Z-statistic for the difference (\[sulbactam-durlobactam + imipenem/cilastatin\] - \[colistin + imipenem/cilastatin\]) in 28-day all-cause mortality rates between the treatment groups.||3.5|-30|
73908008|NCT03894046|147345691|OTHER|||||||0.0002||||||p-value was obtained based on a Chi-Square test for treatment group differences.|Chi-squared|||Analysis of patients with nephrotoxicity as measured by RIFLE criteria at any post-baseline visit based on the Investigator's opinion for the Safety Population for Part A, excluding patients with chronic hemodialysis at baseline baseline.||||0.0002
73908009|NCT03089320|147345781|SUPERIORITY||posterior mean proportion of abstinence|9.12|||||TWO_SIDED|95.0|0.08|31.68|||||The lower and upper limits are credible intervals.|Bayesian analysis was performed, therefore p value is not reported. Bayes factor has been reported instead.||31.68|0.08|
74085176|NCT04511208|147723966|SUPERIORITY||Difference in means|0.62||||0.686|TWO_SIDED|95.0|-2.48|3.71|||Repeated measures linear model|||C3B VMT Score||3.71|-2.48|0.686
74085177|NCT04511208|147723967|SUPERIORITY||Odds Ratio (OR)|2.5||||0.007|TWO_SIDED|95.0|1.28|4.68|||Generalized linear mixed effects model|||||4.68|1.28|0.007
74085178|NCT04511208|147723967|SUPERIORITY||Difference in means|-1.1||||0.009|TWO_SIDED|95.0|-1.82|-0.28|||Repeated measures linear model|||Sensitivity analysis||-0.28|-1.82|0.009
74085179|NCT04511208|147723968|SUPERIORITY||Difference in means|-1.06||||0.004|TWO_SIDED|95.0|-1.75|-0.38|||Repeated measures linear model|||||-0.38|-1.75|0.004
73856824|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.99||||0.385|TWO_SIDED|95.0|-12.86|4.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.88|-12.86|0.385
73964401|NCT04515641|147464464|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.58|1.03|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.03|0.58|
74085180|NCT04511208|147723969|SUPERIORITY||Difference in means|-2.97|||<|0.001|TWO_SIDED|95.0|-3.8|-2.13|||Repeated measures linear model|||||-2.13|-3.80|<0.001
73856825|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.29||||0.162|TWO_SIDED|95.0|-14.97|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.40|-14.97|0.162
73856826|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-76.81|||<|0.001|TWO_SIDED|95.0|-91.35|-62.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-62.27|-91.35|<0.001
73856827|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-70.6|||<|0.001|TWO_SIDED|95.0|-85.79|-55.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-55.41|-85.79|<0.001
73856828|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.66|||<|0.001|TWO_SIDED|95.0|-87.0|-56.31||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.31|-87.00|<0.001
73856829|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-65.19|||<|0.001|TWO_SIDED|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.34|-81.03|<0.001
73856830|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.7||||0.007|TWO_SIDED|95.0|-19.86|-3.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-3.55|-19.86|0.007
73856831|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.94||||0.31|TWO_SIDED|95.0|-14.34|4.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.46|-14.34|0.310
73856832|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-7.36||||0.126|TWO_SIDED|95.0|-16.63|1.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.90|-16.63|0.126
73856833|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-75.64|||<|0.001|TWO_SIDED|95.0|-90.35|-60.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-60.93|-90.35|<0.001
73964402|NCT04515641|147464465|OTHER||GMR|0.96|||||TWO_SIDED|90.0|0.63|1.46|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.46|0.63|
73964403|NCT04515641|147464466|OTHER||GMR|1.05|||||TWO_SIDED|90.0|0.65|1.71|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.71|0.65|
73964404|NCT04515641|147464467|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.59|1.26|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.26|0.59|
74085181|NCT01634854|147723971|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
74085182|NCT01488448|147723979|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
74085183|NCT01488448|147723980|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Fisher Exact|||||||0.77
74085184|NCT01488448|147723981|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Fisher Exact|||||||0.97
74085185|NCT01488448|147723982|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
74085186|NCT01488448|147723983|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.39
74085187|NCT01488448|147723984|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.18
74085188|NCT01488448|147723987|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.96
73856834|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-66.43|||<|0.001|TWO_SIDED|95.0|-81.99|-50.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-50.88|-81.99|<0.001
73908010|NCT03089320|147345782|SUPERIORITY||posterior mean proportion of abstinence|5.5|||||TWO_SIDED|95.0|0.17|18.23|||||The lower and upper limits are credible intervals.|Bayesian analysis was performed, therefore p value is not reported. Bayes factor has been reported instead.||18.23|0.17|
73908011|NCT03089320|147345783|SUPERIORITY||Mean Difference (Final Values)|-4.32|STANDARD_ERROR_OF_MEAN|2.84||0.05|TWO_SIDED|95.0|-9.97|1.34|||Mixed Models Analysis|||mixed effects model||1.34|-9.97|.05
73856835|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-69.33|||<|0.001|TWO_SIDED|95.0|-84.96|-53.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-53.71|-84.96|<0.001
73856836|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-65.19|||<|0.001|TWO_SIDED|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.34|-81.03|<0.001
73856837|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-10.61||||0.016|TWO_SIDED|95.0|-19.02|-2.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-2.19|-19.02|0.016
73856838|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.69||||0.895|TWO_SIDED|95.0|-10.69|9.32||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.32|-10.69|0.895
73908012|NCT03793556|147345793|OTHER||Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|9.27||0.276|TWO_SIDED|95.0|-7.03|2.04|||Unpaired t test|||||2.04|-7.03|0.276
73908013|NCT03793556|147345794|OTHER|||||||0.0157|||||||ANOVA|The ANOVA model examined the entire curve profile.||||||0.0157
73908014|NCT03793556|147345804|OTHER|||||||0.0496|||||||Chi-squared|||||||0.0496
73908015|NCT03793556|147345806|OTHER|||||||0.0065|||||||ANOVA|||||||0.0065
73908016|NCT04612790|147345814|OTHER||Difference in percentage of responders|6.7||||0.509|TWO_SIDED|95.0|-10.9|24.29|||Logistic regression model with Firth adj|||Estimates were from a logistic regression model using the Firth adjustment (adj) that included treatment group, baseline disease severity (moderate, severe) and time of BP diagnosis (participants with newly diagnosed BP, participants with a previous diagnosis of BP who have relapsed) as categorical covariates.||24.29|-10.90|0.509
73964405|NCT04515641|147464468|OTHER||GMR|0.65|||||TWO_SIDED|90.0|0.42|1.01|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.01|0.42|
73964406|NCT02692417|147464471|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
73964407|NCT02692417|147464471|OTHER|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.225
73964408|NCT02692417|147464472|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
73964409|NCT02692417|147464472|OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.046
73964410|NCT02692417|147464473|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
73964411|NCT02692417|147464473|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
73964412|NCT00780234|147464497|OTHER||Regression model parameter (α1)|-0.4|STANDARD_ERROR_OF_MEAN|0.63||0.53|TWO_SIDED|95.0|-1.68|0.89|||Regression, Linear|The estimates of treatment effect were adjusted for baseline histology values.||"The hypotheses tested were:~H0: α1 = 0 vs H1: α1 \~= 0"|The hypothesis test was a 2-sided t-test of the effect of group (i.e. the difference between the pioglitazone and placebo groups). The general form of the model is Y = α0 + α1GROUP + α2BASELINE. Y represents the 6-month value of the dependent variable (summary of the histology), GROUP represents a classification variable for the treatment group (1=pioglitazone, 2=placebo), BASELINE represents the value of the outcome measure at baseline, and α0, α1 and α2 represent the parameter estimates from the general linear model. The test of the difference between groups will be the formal test of significance of the α1 parameter.|0.89|-1.68|0.53
73964413|NCT02178098|147464498|SUPERIORITY||Least squares mean difference|-24.24|STANDARD_ERROR_OF_MEAN|3.08|<|0.0001|TWO_SIDED|95.0|-30.33|-18.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-18.15|-30.33|<0.0001
73964414|NCT02178098|147464499|SUPERIORITY||Least squares mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.511||0.2808|TWO_SIDED|95.0|-4.62|1.35|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.35|-4.62|0.2808
73964415|NCT02178098|147464500|SUPERIORITY||Least squares mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.111||0.3461|TWO_SIDED|95.0|-3.25|1.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.15|-3.25|0.3461
73964416|NCT02178098|147464501|SUPERIORITY||Least squares mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.734||0.1852|TWO_SIDED|95.0|-5.74|1.12|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.12|-5.74|0.1852
73964417|NCT02178098|147464502|SUPERIORITY||Least squares mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.253||0.2481|TWO_SIDED|95.0|-3.93|1.03|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.03|-3.93|0.2481
73964418|NCT02178098|147464503|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.684||0.8181|TWO_SIDED|95.0|-3.72|2.94|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||2.94|-3.72|0.8181
73964419|NCT02178098|147464504|SUPERIORITY||Least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|1.274||0.8817|TWO_SIDED|95.0|-2.33|2.71|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||2.71|-2.33|0.8817
73964420|NCT02178098|147464505|SUPERIORITY||Least squares mean difference|1.53|STANDARD_ERROR_OF_MEAN|1.829||0.404|TWO_SIDED|95.0|-2.09|5.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||5.15|-2.09|0.4040
73964421|NCT02178098|147464506|SUPERIORITY||Least squares mean difference|0.79|STANDARD_ERROR_OF_MEAN|1.178||0.5061|TWO_SIDED|95.0|-1.54|3.11|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||3.11|-1.54|0.5061
73964422|NCT02178098|147464507|SUPERIORITY||Median Difference (Final Values)|-43.64|||<|0.0001|TWO_SIDED|95.0|-62.8|-25.21|||Wilcoxon Rank-Sum Test||The 95% confidence interval (CI) was calculated using Hodges-Lehmann analysis.|||-25.21|-62.80|<0.0001
74025949|NCT03478683|147604892|SUPERIORITY||Mean Difference (Net)|0.038|STANDARD_ERROR_OF_MEAN|0.014||0.007|TWO_SIDED|95.0|0.01|0.066||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85|||0.066|0.010|0.007
73964423|NCT02178098|147464508|SUPERIORITY||Least squares mean difference|-16.67|STANDARD_ERROR_OF_MEAN|2.006|<|0.0001|TWO_SIDED|95.0|-20.63|-12.7|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-12.70|-20.63|<0.0001
73856839|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.09||||0.308|TWO_SIDED|95.0|-14.8|4.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.62|-14.80|0.308
73856840|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.36|||<|0.001|TWO_SIDED|95.0|-86.58|-56.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.13|-86.58|<0.001
73856841|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.11|||<|0.001|TWO_SIDED|95.0|-78.04|-46.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.19|-78.04|<0.001
73856842|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-64.57|||<|0.001|TWO_SIDED|95.0|-80.64|-48.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-48.50|-80.64|<0.001
73856843|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-59.84|||<|0.001|TWO_SIDED|95.0|-76.12|-43.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-43.55|-76.12|<0.001
73856844|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.49||||0.028|TWO_SIDED|95.0|-21.63|-1.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-1.35|-21.63|0.028
73856845|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-1.88||||0.747|TWO_SIDED|95.0|-13.15|9.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.38|-13.15|0.747
73856846|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.88||||0.303|TWO_SIDED|95.0|-16.88|5.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.12|-16.88|0.303
73856847|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.49|||<|0.001|TWO_SIDED|95.0|-78.64|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.34|-78.64|<0.001
73908017|NCT05021081|147345826|OTHER|The least-square means (i.e., adjusted means) of photopic contrast sensitivity at 6 cpd was estimated separately under conditions with glare source and without glare source. This endpoint was not statistically tested, and consequentially statistical interferences was not made.|Least-square Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED|95.0|-0.7|-0.21|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as With glare minus Without glare|The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean photopic contrast sensitivity with and without the glare source.||-0.21|-0.70|
73908018|NCT05021081|147345827|OTHER|The least-square means (i.e., adjusted means) of mesopic contrast sensitivity at 6 cpd was estimated separately under conditions with glare source and without glare source. This endpoint was not statistically tested, and consequentially statistical interferences was not made.|Least-square Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|95.0|-0.81|-0.36|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as With glare minus Without glare|The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean mesopic contrast sensitivity with and without the glare source.||-0.36|-0.81|
73908019|NCT05021081|147345828|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% confidence interval of the mean difference was below 0.|Least-square Mean Difference|0.019|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|-0.029|0.068|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Given no historical data is available, the sample size was not determined based on any empirical sample size calculation. A power analysis was conducted using a paired sample t-test (exact method) with a 2-sided type I error rate 0.05 to estimate statistical power based on different assumptions. The power analysis showed that the statistical power for testing superiority would be approximately 80% or higher with the effect size of -0.05 (mean difference: Test minus Control).||0.068|-0.029|
73908020|NCT00369122|147345831|OTHER||||||||||||||||||Based on a report by Laciano, et al. an SAE rate of 5% and AE rate of 35% were considered tolerable and an SAE rate \>=20% and AE rate \>=55% excessive. If there were \>=6 pts with SAES or \>=22 pts with AEs then the treatment would be rejected. This study design provides alpha of 0.05 and power of 90%.|||
73908021|NCT00408629|147345835|SUPERIORITY_OR_OTHER|||||||0.019||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.||||0.019
73908022|NCT00408629|147345836|SUPERIORITY_OR_OTHER|||||||0.004||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.||||0.004
73908023|NCT00408629|147345837|SUPERIORITY_OR_OTHER|||||||0.047||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.047
73908024|NCT00408629|147345838|SUPERIORITY_OR_OTHER||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||<0.001
73908025|NCT00408629|147345839|SUPERIORITY_OR_OTHER|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.002
73964424|NCT02178098|147464509|SUPERIORITY||Least squares mean difference|-18.9|STANDARD_ERROR_OF_MEAN|2.624|<|0.0001|TWO_SIDED|95.0|-24.09|-13.71|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.71|-24.09|<0.0001
73964425|NCT02178098|147464510|SUPERIORITY||Least squares mean difference|-18.69|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001|TWO_SIDED|95.0|-23.62|-13.77|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.77|-23.62|<0.0001
73964426|NCT02178098|147464511|SUPERIORITY||Median Difference (Final Values)|5.25||||0.3689|TWO_SIDED|95.0|-6.78|16.42|||Wilcoxon Rank-Sum Test||The 95% CI was calculated using Hodges-Lehmann analysis.|||16.42|-6.78|0.3689
73964427|NCT02178098|147464512|SUPERIORITY||Least squares mean difference|-8.18|STANDARD_ERROR_OF_MEAN|2.319||0.0006|TWO_SIDED|95.0|-12.76|-3.59|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-3.59|-12.76|0.0006
73964428|NCT02178098|147464513|SUPERIORITY||Median Difference (Final Values)|7.6||||0.3093|TWO_SIDED|95.0|-8.21|24.02|||Wilcoxon Rank-Sum Test||The 95% CI was calculated using Hodges-Lehmann analysis.|||24.02|-8.21|0.3093
73964429|NCT00957242|147464516|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.32||||0.27|TWO_SIDED|95.0|0.7|2.47|||Regression, Cox|Prespecified covariates in the model included an indicator variable for the treatment group and the DLCO measurement from the baseline assessment.|Warfarin vs. Placebo|The study was designed to have 90% power to detect a difference in 48-week event free rates of 70% for the warfarin group versus 50% for the placebo group. A total of at least 95 adjudicated primary endpoints were required to achieve 90% power with 2-sided, type I error rate of 0.05 and a 1:1 randomization ratio. These calculations yielded a requisite total sample size of 256.||2.47|0.70|0.27
73964430|NCT00957242|147464517|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|5.03||||0.005|TWO_SIDED|95.0|1.44|17.54|||Cox Proportional|||||17.54|1.44|0.005
73964431|NCT00957242|147464518|SUPERIORITY_OR_OTHER||t-value|0.08||||0.083||95.0|-0.01|0.17|||Mixed Models Analysis|||||0.17|-0.01|0.083
73964432|NCT00957242|147464519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.054|TWO_SIDED|95.0|0.99|4.31|||Cox Proportional|||||4.31|0.99|0.054
73964433|NCT00957242|147464520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.47||||0.19|TWO_SIDED|95.0|0.64|9.56|||Cox Proportional|||||9.56|0.64|0.19
73964434|NCT00957242|147464521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.25||||0.35|TWO_SIDED|95.0|0.41|12.34|||Cox Proportional|||||12.34|0.41|0.35
74025950|NCT03478683|147604893|SUPERIORITY||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.011||0.415|TWO_SIDED|95.0|-0.03|0.013||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.013|-0.030|0.415
73964435|NCT00957242|147464522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.24||||0.15|TWO_SIDED|95.0|0.65|16.1|||Cox Proportional|||||16.10|0.65|0.15
74025951|NCT03478683|147604894|SUPERIORITY||Mean Difference (Net)|0.013|STANDARD_ERROR_OF_MEAN|0.0138||0.335|TWO_SIDED|95.0|-0.014|0.04||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.040|-0.014|0.335
74025952|NCT05175170|147604895|OTHER||Mean Difference (Final Values)|-33.902|||<|0.001|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.||||<.001
73964436|NCT00957242|147464523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.88|TWO_SIDED|95.0|0.24|3.39|||Cox Proportional|||||3.39|0.24|0.88
73964437|NCT00957242|147464524|SUPERIORITY_OR_OTHER||t-value|10.88||||0.7222|TWO_SIDED|95.0|-49.57|71.34|||Mixed Models Analysis|||||71.34|-49.57|0.7222
73964438|NCT00957242|147464525|SUPERIORITY_OR_OTHER||t-value|-1.78||||0.27|TWO_SIDED|95.0|-7.04|3048.0|||Mixed Models Analysis|||||3048|-7.04|0.27
73964439|NCT00957242|147464526|SUPERIORITY_OR_OTHER||t-value|0.05||||0.957|TWO_SIDED|95.0|-1.67|1076.0|||Mixed Models Analysis|||||1076|-1.67|0.957
73964440|NCT00957242|147464527|SUPERIORITY_OR_OTHER||t-value|-0.48||||0.009|TWO_SIDED|95.0|-0.84|-0.12|||Mixed Models Analysis|||||-0.12|-0.84|0.009
73964441|NCT01553058|147464562|OTHER|Difference of Differences||||||0.795|||||||Regression, Linear|||||||0.795
73964442|NCT01553058|147464562|OTHER|Difference of differences||||||0.647|||||||Regression, Linear|||||||0.647
73964443|NCT01553058|147464563|OTHER|Difference of differences||||||0.386|||||||Regression, Linear|||||||0.386
73964444|NCT01553058|147464563|OTHER|Difference of Differences||||||0.28|||||||Regression, Linear|||||||0.280
73964445|NCT01553058|147464570|OTHER|Difference of Differences||||||0.357|||||||Regression, Linear|||||||0.357
73964446|NCT01553058|147464570|OTHER|Difference of Differences||||||0.496|||||||Regression, Linear|||||||0.496
73964447|NCT01553058|147464571|OTHER|Difference of Differences||||||0.897|||||||Regression, Linear|||||||0.897
73964448|NCT01553058|147464571|OTHER|Difference of differences||||||0.467|||||||Regression, Linear|||||||0.467
73964449|NCT01553058|147464572|OTHER|Difference of differences||||||0.089|||||||Regression, Linear|||||||0.089
73964450|NCT01553058|147464572|OTHER|Difference of differences||||||0.03|||||||Regression, Linear|||||||0.030
73964451|NCT01553058|147464573|OTHER|Difference of differences||||||0.934|||||||Regression, Linear|||||||0.934
73964452|NCT01553058|147464573|OTHER|Difference of differences||||||0.679|||||||Regression, Linear|||||||0.679
73964453|NCT01553058|147464574|OTHER|Difference of differences||||||0.672|||||||Regression, Linear|||||||0.672
73964454|NCT01553058|147464574|OTHER|Difference of differences||||||0.655|||||||Regression, Linear|||||||0.655
73964455|NCT01553058|147464575|OTHER|Difference of differences||||||0.504|||||||Regression, Linear|||||||0.504
73964456|NCT01553058|147464575|OTHER|Difference of differences||||||0.695|||||||Regression, Linear|||||||0.695
73964457|NCT01553058|147464576|OTHER|Difference of differences||||||0.002|||||||Regression, Linear|||||||0.002
73964458|NCT01553058|147464576|OTHER|Difference of differences||||||0.009|||||||Regression, Linear|||||||0.009
73964459|NCT01553058|147464577|OTHER|Difference of Differences|||||<|0.001|||||||Regression, Linear|||||||<0.001
73964460|NCT01553058|147464577|OTHER|Difference of differences||||||0.065|||||||Regression, Linear|||||||0.065
73964461|NCT01553058|147464578|OTHER|Difference of differences||||||0.007|||||||Regression, Linear|||||||0.007
73964462|NCT01553058|147464578|OTHER|Difference of differences||||||0.019|||||||Regression, Linear|||||||0.019
73964463|NCT01553058|147464579|OTHER|Difference of differences||||||0.006|||||||Regression, Linear|||||||0.006
73964464|NCT01553058|147464579|OTHER|Difference of differences||||||0.628|||||||Regression, Linear|||||||0.628
73908026|NCT00408629|147345840|SUPERIORITY_OR_OTHER||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||<0.001
73964465|NCT04048382|147464588|SUPERIORITY||Odds Ratio (OR)|1.1||||0.88|TWO_SIDED||||||Regression, Logistic|||||||.88
73856848|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-60.09|||<|0.001|TWO_SIDED|95.0|-76.15|-44.02||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-44.02|-76.15|<0.001
73856849|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-63.45|||<|0.001|TWO_SIDED|95.0|-79.64|-47.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-47.27|-79.64|<0.001
73856850|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-53.41|||<|0.001|TWO_SIDED|95.0|-70.1|-36.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-36.72|-70.10|<0.001
73856851|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-9.14||||0.137|TWO_SIDED|95.0|-21.18|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.90|-21.18|0.137
73856852|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.34||||0.311|TWO_SIDED|95.0|-18.39|5.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.71|-18.39|0.311
73856853|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.23||||0.067|TWO_SIDED|95.0|-22.97|0.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||0.52|-22.97|0.067
73856854|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-51.54|||<|0.001|TWO_SIDED|95.0|-68.42|-34.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-34.66|-68.42|<0.001
73856855|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-57.01|||<|0.001|TWO_SIDED|95.0|-73.27|-40.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-40.76|-73.27|<0.001
73856856|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-53.21|||<|0.001|TWO_SIDED|95.0|-70.16|-36.26||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-36.26|-70.16|<0.001
73856857|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-47.82|||<|0.001|TWO_SIDED|95.0|-64.81|-30.83||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-30.83|-64.81|<0.001
73856858|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.52||||0.604|TWO_SIDED|95.0|-16.89|9.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.85|-16.89|0.604
73856859|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-8.78||||0.184|TWO_SIDED|95.0|-21.5|3.94||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.94|-21.50|0.184
73856860|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.43||||0.34|TWO_SIDED|95.0|-19.56|6.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||6.70|-19.56|0.340
73908027|NCT00408629|147345841|SUPERIORITY_OR_OTHER|||||||0.032||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure were needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.032
73908028|NCT00408629|147345842|SUPERIORITY_OR_OTHER|||||||0.009||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.009
73908029|NCT00408629|147345843|SUPERIORITY_OR_OTHER|||||||0.013||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.013
73908030|NCT00408629|147345844|SUPERIORITY_OR_OTHER|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.035
73908031|NCT00408629|147345845|SUPERIORITY_OR_OTHER|||||||0.058||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.058
73908032|NCT00408629|147345846|SUPERIORITY_OR_OTHER|||||||0.028||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.028
73908033|NCT00408629|147345847|SUPERIORITY_OR_OTHER|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.006
73908034|NCT00408629|147345848|SUPERIORITY_OR_OTHER|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.035
73908035|NCT00408629|147345849|SUPERIORITY_OR_OTHER|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.002
73964466|NCT04048382|147464589|SUPERIORITY||Odds Ratio (OR)|1.7||||0.49|TWO_SIDED||||||Regression, Logistic|||||||.49
73964467|NCT04048382|147464590|SUPERIORITY||Odds Ratio (OR)|1.1||||0.91|TWO_SIDED||||||Regression, Logistic|||||||.91
73964468|NCT04048382|147464591|SUPERIORITY||Odds Ratio (OR)|1.4||||0.65|TWO_SIDED||||||Regression, Logistic|||||||.65
73964469|NCT04048382|147464592|SUPERIORITY||Odds Ratio (OR)|0.29||||0.17|TWO_SIDED||||||Regression, Logistic|||||||.17
73964470|NCT04048382|147464593|SUPERIORITY||Odds Ratio (OR)|0.29||||0.19|TWO_SIDED||||||Regression, Logistic|||||||.19
73964471|NCT01255670|147464606|OTHER|Mann-Whitney U-test and Fisher's exact test||||||0.05|||||||Fisher Exact|||||||0.05
73964472|NCT01255670|147464607|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U-test and Fisher's exact test||||0.05
73964473|NCT01037985|147464608|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.168|TWO_SIDED|95.0|-10.4|1.9|||t-test, 2 sided|||Within participant treatment difference was assessed between the treatment regimens each participant received (EXC 001 minus placebo).||1.9|-10.4|0.168
73964474|NCT01037985|147464609|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.858|TWO_SIDED|95.0|-3.5|4.2|||t-test, 2 sided|||Within participant treatment difference was assessed between the treatment regimens each participant received (EXC 001 minus placebo).||4.2|-3.5|0.858
73964475|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.003|TWO_SIDED|95.0|-1.6|-0.4|||t-test, 2 sided|||Week 12, Vascularity: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.6|0.003
73908036|NCT00408629|147345850|SUPERIORITY_OR_OTHER|||||||0.007||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.007
73908037|NCT00408629|147345851|SUPERIORITY_OR_OTHER|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.006
73908038|NCT00191906|147345852|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||P-value for Overall. No adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.504
73908039|NCT00191906|147345853|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus Normal controls.||||0.970
73908040|NCT00191906|147345854|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.||||0.579
73908041|NCT00191906|147345854|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests are performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for RD versus RD controls.||||0.144
73908042|NCT00191906|147345855|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment by study-arm-interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.005
73908043|NCT00191906|147345856|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.097
73908044|NCT00191906|147345857|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.003
74025953|NCT05175170|147604895|OTHER||Mean Difference (Final Values)|-26.098|||<|0.001|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.||||<.001
74025954|NCT05175170|147604896|OTHER||Mean Difference (Final Values)|-20.202||||0.002|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.||||0.002
73908045|NCT00191906|147345858|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
73908046|NCT00191906|147345859|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
73908047|NCT00191906|147345860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
73908048|NCT00191906|147345861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
74025955|NCT05175170|147604896|OTHER||Mean Difference (Final Values)|-8.081||||0.051|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.||||0.051
73908049|NCT00191906|147345862|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||||||0.094
73908050|NCT00191906|147345863|SUPERIORITY_OR_OTHER|||||||0.312||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction||||||0.312
73908051|NCT00191906|147345864|SUPERIORITY_OR_OTHER|||||||0.508||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus normal controls.||||0.508
73908052|NCT00191906|147345865|SUPERIORITY_OR_OTHER|||||||0.769||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C versus normal controls||||0.769
73908053|NCT00191906|147345866|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.||||0.302
73908054|NCT00191906|147345866|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.||||0.663
73908055|NCT00191906|147345867|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C+RD versus RD controls.||||0.070
73908056|NCT00191906|147345867|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.||||0.179
73908057|NCT00333801|147345870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73908058|NCT00333801|147345871|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73908059|NCT00333801|147345872|SUPERIORITY_OR_OTHER_LEGACY||Cohen's d|0.93|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73908060|NCT01950169|147345894|SUPERIORITY|||||||0.05|||||||ANCOVA|Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.||||||0.05
73908061|NCT01950169|147345895|SUPERIORITY|||||||0.05|||||||ANCOVA|Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.||||||0.05
73908062|NCT01950169|147345896|SUPERIORITY|||||||0.05|||||||ANCOVA|The analyses included exposure measures treatment groups and sex as fixed factors. Age and baseline values for FFMI, FMI were included as covariates.||||||0.05
73908063|NCT01680887|147345901|SUPERIORITY|||||||0.403|||||||Chi-squared|||||||.403
73908064|NCT01254292|147345907|SUPERIORITY_OR_OTHER||single proportion|82.1|||||TWO_SIDED|95.0|77.1|86.5|||||Clopper Pearson Confidence Interval|||86.5|77.1|
73908065|NCT01254292|147345907|SUPERIORITY_OR_OTHER||single proportion|81.9|||||TWO_SIDED|95.0|76.7|86.4|||||Clopper Pearson Confidence Interval|||86.4|76.7|
73908066|NCT02337738|147345965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84||||0.0006|TWO_SIDED|95.0|-1.32|-0.364|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).|||-0.364|-1.320|0.0006
73908067|NCT02337738|147345965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.014|TWO_SIDED|95.0|-1.07|-0.122|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 0.5mg and Placebo (TVP-1012 0.5mg - Placebo).|||-0.122|-1.070|0.0140
74025956|NCT02625402|147604900|EQUIVALENCE|Knowledge scores within 10% points|Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|7.6|<|0.05|TWO_SIDED|95.0|-8.8|21.5|||t-test, 2 sided|||||21.5|-8.8|<0.05
73908068|NCT00406354|147345976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-1.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-1.5|-5.0|<.001
73908069|NCT00406354|147345977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-3.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-3.8|-11.0|<.001
73908070|NCT00406354|147345978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-1.8|-5.3|<.001
73908071|NCT00406354|147345979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-5.8|-2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-2.0|-5.8|<.001
73908072|NCT00406354|147345980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.2|-0.6|<.001
74025957|NCT02332915|147604903|SUPERIORITY|||||||0.0128|||||||t-test, 2 sided|dependent t-test||Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for treated items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).||||.0128
73908073|NCT00406354|147345981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.4|-0.1||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.1|-0.4|0.006
73856861|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-40.27|||<|0.001|TWO_SIDED|95.0|-57.67|-22.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.88|-57.67|<0.001
73856862|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-47.24|||<|0.001|TWO_SIDED|95.0|-64.21|-30.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-30.27|-64.21|<0.001
73856863|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-43.15|||<|0.001|TWO_SIDED|95.0|-60.57|-25.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-25.72|-60.57|<0.001
73856864|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-44.45|||<|0.001|TWO_SIDED|95.0|-61.55|-27.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-27.34|-61.55|<0.001
73856865|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|4.29||||0.548|TWO_SIDED|95.0|-9.8|18.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.38|-9.80|0.548
73856866|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.51||||0.721|TWO_SIDED|95.0|-16.2|11.18||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.18|-16.20|0.721
73856867|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.44||||0.951|TWO_SIDED|95.0|-13.47|14.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.35|-13.47|0.951
73856868|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-29.13||||0.005|TWO_SIDED|95.0|-46.66|-11.59||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-11.59|-46.66|0.005
73856869|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-34.3||||0.001|TWO_SIDED|95.0|-51.62|-16.97||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-16.97|-51.62|0.001
73856870|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-36.26|||<|0.001|TWO_SIDED|95.0|-53.8|-18.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-18.73|-53.80|<0.001
73856871|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-34.56|||<|0.001|TWO_SIDED|95.0|-51.77|-17.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-17.35|-51.77|<0.001
73856872|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.45||||0.455|TWO_SIDED|95.0|-8.89|19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.79|-8.89|0.455
73964476|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.067|TWO_SIDED|95.0|-1.1|0.0|||t-test, 2 sided|||Week 12, Pigmentation: Comparison within the participant between EXC 001 and placebo.||0.0|-1.1|0.067
73964477|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.001|TWO_SIDED|95.0|-2.1|-0.7|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.7|-2.1|<0.001
73964478|NCT01037985|147464610|SUPERIORITY||Median Difference (Final Values)|-0.9||||0.002|TWO_SIDED|95.0|-1.4|-0.4|||t-test, 2 sided|||Week 12, Relief: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.4|0.002
73908074|NCT00406354|147345982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|95.0|-6.2|-0.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.9|-6.2|0.010
73908075|NCT00406354|147345983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.7||0.01|TWO_SIDED|95.0|-3.2|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-3.2|0.010
73908076|NCT00406354|147345984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.7||0.406|TWO_SIDED|95.0|-4.9|2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Negative values are in favor of the atomoxetine arms.|||2.0|-4.9|0.406
73908077|NCT00406354|147345985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
73908078|NCT00406354|147345986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
73908079|NCT00406354|147345987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
73908080|NCT00406354|147345988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.2||0.021|TWO_SIDED|95.0|0.8|9.3||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||9.3|0.8|0.021
73908081|NCT00406354|147345989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|3.1||0.017|TWO_SIDED|95.0|-13.8|-1.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||-1.4|-13.8|0.017
73908082|NCT00406354|147345990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|2.8||0.05|TWO_SIDED|95.0|0.0|10.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||10.9|-0.0|0.050
74025958|NCT02332915|147604904|SUPERIORITY|||||||0.942|||||||t-test, 2 sided|dependent t-test||Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for untreated (generalization) items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).||||.942
73908083|NCT00406354|147345991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|4.9|16.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||16.4|4.9|<.001
73908084|NCT00406354|147345992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|3.3||0.015|TWO_SIDED|95.0|1.6|14.6||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||14.6|1.6|0.015
73908085|NCT00406354|147345993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.4||0.018|TWO_SIDED|95.0|1.4|14.7||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive results are in favor of the atomoxetine arms.|||14.7|1.4|0.018
73908086|NCT00406354|147345994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|3.3||0.138|TWO_SIDED|95.0|-1.6|11.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||11.5|-1.6|0.138
73908087|NCT00406354|147345995|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.193||||0.016||95.0|1.16|4.146||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Log Rank|||||4.146|1.160|0.016
73908088|NCT00406354|147345996|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the initial three weeks of study treatment|Fisher Exact|||||||0.102
73908089|NCT00406354|147345997|SUPERIORITY_OR_OTHER|||||||0.101||95.0||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the nine-week study treatment period.|Fisher Exact|||||||0.101
73908090|NCT01460368|147345998|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|||||TWO_SIDED|90.0|-1.38|2.63|||||Treatment comparison at 2 hours.|||2.63|-1.38|
73908091|NCT01460368|147345998|SUPERIORITY_OR_OTHER||Least Squares Means Difference|3.69|||||TWO_SIDED|90.0|1.67|5.71|||||Treatment comparison at 4 hours.|||5.71|1.67|
73908092|NCT01460368|147345998|SUPERIORITY_OR_OTHER||Least Squares Means Difference|9.14|||||TWO_SIDED|90.0|7.12|11.16|||||Treatment comparison at 6 hours.|||11.16|7.12|
73908093|NCT01460368|147345998|SUPERIORITY_OR_OTHER||Least Squares Means Difference|9.08|||||TWO_SIDED|90.0|7.1|11.07|||||Treatment comparison at 8 hours.|||11.07|7.10|
73908094|NCT01460368|147345998|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-0.15|||||TWO_SIDED|90.0|-2.14|1.85|||||Treatment comparison at 12 hours.|||1.85|-2.14|
73908095|NCT01460368|147345998|SUPERIORITY_OR_OTHER||Least Squares Means Difference|3.63|||||TWO_SIDED|90.0|1.63|5.63|||||Treatment comparison at 24 hours.|||5.63|1.63|
73908096|NCT01460368|147345999|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|8.07|||||TWO_SIDED|90.0|5.21|10.94|||||Treatment comparison at 2 hours.|||10.94|5.21|
73908097|NCT01460368|147345999|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.56|||||TWO_SIDED|90.0|7.69|13.43|||||Treatment comparison at 4 hours.|||13.43|7.69|
74025959|NCT02332915|147604905|OTHER||||||<|0.001|||||||t-test, 2 sided|||Null Hypothesis: No difference in pre-treatment and post-treatment intelligibility scores||||<.001
74025960|NCT02128490|147604982|SUPERIORITY_OR_OTHER||Difference in Proportions|35.9|||<|0.001|TWO_SIDED|95.0|20.8|51.0|||Fisher Exact|||||51.0|20.8|<0.001
74025961|NCT02128490|147604982|SUPERIORITY_OR_OTHER||Difference in Proportions|44.7|||<|0.001|TWO_SIDED|95.0|28.9|60.5|||Fisher Exact|||||60.5|28.9|<0.001
74025962|NCT02128490|147604982|SUPERIORITY_OR_OTHER||Difference in Proportions|22.4||||0.034|TWO_SIDED|95.0|3.7|41.0|||Fisher Exact|||||41.0|3.7|0.034
74025963|NCT02128490|147604982|SUPERIORITY_OR_OTHER||Difference in Proportions|4.2||||0.817|TWO_SIDED|95.0|-18.2|26.6|||Fisher Exact|||||26.6|-18.2|0.817
74025964|NCT02128490|147604983|SUPERIORITY_OR_OTHER||Difference in Proportions|12.6||||0.224|TWO_SIDED|95.0|-3.9|29.0|||Fisher Exact|||||29.0|-3.9|0.224
74025965|NCT02128490|147604983|SUPERIORITY_OR_OTHER||Difference in Proportions|31.6||||0.004|TWO_SIDED|95.0|13.1|50.1|||Fisher Exact|||||50.1|13.1|0.004
74025966|NCT02128490|147604983|SUPERIORITY_OR_OTHER||Difference in Proportions|-17.5||||0.139|TWO_SIDED|95.0|-38.1|3.2|||Fisher Exact|||||3.2|-38.1|0.139
74025967|NCT02128490|147604983|SUPERIORITY_OR_OTHER||Difference in Proportions|4.3||||0.815|TWO_SIDED|95.0|-17.9|26.4|||Fisher Exact|||||26.4|-17.9|0.815
73908098|NCT05055453|147346009|OTHER|A Shapiro Wilks test was used to test for normal distribution of the data.|||||<|0.001||||||"Result for comparison between automatic only and preferred app settings."|Durbin-Conover Pairwise Comparison|||||||<0.001
73908099|NCT05055453|147346009|OTHER||||||<|0.001||||||"Result of comparison between preferred app setting and extreme app setting"|Durbin-Conover Pairwise Comparison|||A Shapiro Wilks test was used to test for normal distribution of the data.||||< 0.001
73908100|NCT05055453|147346009|OTHER|"Result of comparison between automatic only and extreme app setting."||||||0.002|||||||Durbin-Conover Pairwise Comparison|||A Shapiro Wilks test was used to test for normal distribution of the data.||||0.002
73908101|NCT05055453|147346010|OTHER|Analysis of first home trial|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73908102|NCT05055453|147346010|OTHER||||||<|0.001|||||||t-test, 2 sided|||Analysis of second home trial||||<.001
73908103|NCT01224665|147346011|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.45|TWO_SIDED|95.0|0.86|1.4||Using an intention-to-treat analysis, we specified a stratified log-rank test with a one-sided alpha of 0.025.|Log Rank|Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|3-year DFS estimates of 55% among participants undergoing SLND and 65% undergoing ELND were used to estimate the target HR. Assuming exponential DFS distribution, 5 years of enrollment, 3 years of follow-up, and 564 eligible participants, the trial would have 85% power to detect a 28% lower risk of recurrence or death with ELND than SLND.||1.40|0.86|0.45
74025968|NCT02128490|147604984|SUPERIORITY_OR_OTHER||Difference in Proportions|53.8|||<|0.001|TWO_SIDED|95.0|38.2|69.5|||Fisher Exact|||||69.5|38.2|<0.001
73908104|NCT01224665|147346012|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.88|1.45|||||Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|We assumed that the standard lymphadenectomy arm has 5-year survival of 55%, so we had 83% statistical power to detect a hazard ratio of 0.72 (55% vs. 65% survival at 5 years).||1.45|0.88|
73908105|NCT03467048|147346054|NON_INFERIORITY|Null hypothesis: McGrath Video Laryngoscopy is non-inferior to Macintosh direct laryngoscopy.|Odds Ratio (OR)|4.65|||<|0.01|TWO_SIDED|95.0|2.22|9.75|||t-test, 1 sided|||||9.75|2.22|<0.01
73908106|NCT03467048|147346055|NON_INFERIORITY|Null hypothesis: McGrath videolaryngoscopy is non-inferior to Direct laryngoscopy|Odds Ratio (OR)|0.3||||0.08|TWO_SIDED|0.975|0.04|2.28|||t-test, 1 sided|||||2.28|0.04|0.08
74025969|NCT02128490|147604984|SUPERIORITY_OR_OTHER||Difference in Proportions|55.3|||<|0.001|TWO_SIDED|95.0|39.5|71.1|||Fisher Exact|||||71.1|39.5|<0.001
74025970|NCT02128490|147604984|SUPERIORITY_OR_OTHER||Difference in Proportions|21.4||||0.069|TWO_SIDED|95.0|-0.3|43.1|||Fisher Exact|||||43.1|-0.3|0.069
74025971|NCT02128490|147604984|SUPERIORITY_OR_OTHER||Difference in Proportions|-4.2||||0.817|TWO_SIDED|95.0|-26.6|18.2|||Fisher Exact|||||18.2|-26.6|0.817
74025972|NCT02243176|147604985|NON_INFERIORITY_OR_EQUIVALENCE|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6236|TWO_SIDED|95.0|-0.22|0.13||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA\< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA\< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."||0.13|-0.22|0.6236
74085189|NCT01475487|147723994|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 21 participants per group was required to detect a 40% absolute difference in the complication rate between DP and US guided techniques assuming a 45% complication rate in the DP (control) group and using the Fisher's exact test for the comparison of independent proportions. A total of 23 and 24 participants were recruited in the DP and US group, respectively.|||||<|0.01|TWO_SIDED||||||Fisher Exact|||||||<0.01
74085190|NCT01475487|147723995|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.88||||0.001|TWO_SIDED|95.0|1.39|5.94|||Fisher Exact||Risk of injury ( none-mild vs moderate -severe) for all participants|||5.94|1.39|0.001
73908107|NCT03467048|147346056|NON_INFERIORITY|Null hypothesis: McGrath videolaryngoscopy is non-inferior to Direct laryngoscopy|Odds Ratio (OR)|0.87||||0.41|TWO_SIDED|97.5|0.1|7.77|||t-test, 1 sided|||||7.77|0.1|0.41
73908108|NCT01898208|147346057|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Kruskal-Wallis|||For Vancomycin, all patients||||0.92
73908109|NCT01898208|147346057|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin, organisms not requiring vancomycin.||||0.032
73908110|NCT01898208|147346057|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin-susceptible enterococci||||0.037
73908111|NCT01898208|147346057|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin, methicillin-susceptible Staphylococcus aureus.||||0.2
73908112|NCT01898208|147346057|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Kruskal-Wallis|||For nafcillin, oxacillin, or cefazolin.||||0.035
73908113|NCT01898208|147346057|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Kruskal-Wallis|||For piperacillin-tazobactam.||||0.012
73908114|NCT01898208|147346057|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Kruskal-Wallis|||For cefepime.||||0.56
73908115|NCT01898208|147346058|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the 3 groups.||||0.55
73908116|NCT01898208|147346059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||For time to first appropriate de-escalation comparing the 3 groups.||||<0.0001
73908117|NCT01898208|147346059|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Kruskal-Wallis|||For time to first appropriate escalation comparing the 3 groups.||||0.04
73908118|NCT01898208|147346060|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||Chi-squared|||This analysis compares the 3 groups.||||0.015
73908119|NCT01898208|147346061|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the FilmArray test to control arm.||||<0.0001
73908120|NCT01898208|147346061|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares FilmArray plus antimicrobial stewardship to the control arm.||||<0.0001
73908121|NCT01898208|147346062|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Kruskal-Wallis|||This analysis is to compare the three groups.||||0.79
73908122|NCT01898208|147346063|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Kruskal-Wallis|||||||0.90
73908123|NCT01898208|147346064|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Chi-squared|||This analysis is a comparison of the 3 groups.||||0.62
73908124|NCT01898208|147346065|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the three groups.||||0.60
73908125|NCT01898208|147346066|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Fisher Exact|||Comparison of the 3 groups for all-cause mortality.||||0.74
73908126|NCT01898208|147346066|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Fisher Exact|||Comparison of the 3 groups for attributable mortality.||||0.42
73908127|NCT01898208|147346067|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Fisher Exact|||This analysis is a comparison across all three groups.||||0.82
73908128|NCT01898208|147346069|SUPERIORITY_OR_OTHER|||||||0.7789|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for total hospitalization costs.||||0.7789
73908129|NCT01898208|147346069|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for laboratory test cost.||||0.0006
73908130|NCT01898208|147346069|SUPERIORITY_OR_OTHER|||||||0.654|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for antimicrobials costs.||||0.6540
74085191|NCT01475487|147723995|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Grade 3-4 comparison of None-mild and moderate-severe||||<0.001
73908131|NCT06350474|147346129|NON_INFERIORITY|The non-inferiority margin is -3.|Mean Difference (Final Values)|0.346|||<|0.0001|TWO_SIDED|95.0|-0.5|1.1||One-sided test for non-inferiority.|ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population.||1.1|-0.5|<0.0001
73908132|NCT06350474|147346130|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.414|TWO_SIDED|95.0|-0.4|0.2|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.2|-0.4|0.414
73908133|NCT06350474|147346131|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.241|TWO_SIDED|95.0|-1.0|2.9|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||2.9|-1.0|0.241
73908134|NCT06350474|147346132|SUPERIORITY||Mean Difference (Final Values)|-0.92||||0.233|TWO_SIDED|95.0|-2.5|0.6|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.6|-2.5|0.233
73908135|NCT06350474|147346133|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.42|TWO_SIDED|95.0|-0.4|0.97|||t-test, 2 sided||Direction of difference is Discontinue - Continue.|||0.97|-0.4|0.42
73908136|NCT06350474|147346134|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.69|TWO_SIDED|95.0|-0.92|0.61|||t-test, 2 sided||Direction of difference is Discontinue - Continue.|||0.61|-0.92|0.69
73908137|NCT06350474|147346135|SUPERIORITY||Difference in % Participants|2.5||||0.275|TWO_SIDED|95.0|-1.5|6.5|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|||6.5|-1.5|0.275
73908138|NCT06350474|147346137|SUPERIORITY||Difference in % Participants|0.8||||0.686|TWO_SIDED|95.0|-1.6|3.4|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|||3.4|-1.6|0.686
73908139|NCT06350474|147346138|SUPERIORITY||Difference in % Participants|13.9||||0.001|TWO_SIDED|95.0|5.6|21.8|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one AE is the same in Discontinue and Continue arms.||21.8|5.6|0.0010
73908140|NCT06350474|147346139|SUPERIORITY||Rate Ratio|1.95|||<|0.0001|TWO_SIDED|95.0|1.51|2.53|||Poisson Regression|||Rate ratio, confidence interval, and p-value calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the DA-discontinue and DA-continue arms are 1486.3 and 1471.4 weeks, respectively. Ratio is Discontinue / Continue.||2.53|1.51|<0.0001
73908141|NCT06350474|147346140|SUPERIORITY||Difference in % Participants|2.03||||0.1758|TWO_SIDED|95.0|-0.6|5.0|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.0|-0.6|0.1758
73908142|NCT03633617|147346170|SUPERIORITY||Difference in proportion|55.3|||<|0.0001|TWO_SIDED|95.0|39.58|71.04|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||71.04|39.58|<0.0001
73908143|NCT03633617|147346170|SUPERIORITY||Difference in proportion|56.0|||<|0.0001|TWO_SIDED|95.0|43.44|68.54|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||68.54|43.44|<0.0001
73908144|NCT03633617|147346170|SUPERIORITY||Difference in proportion|53.5|||<|0.0001|TWO_SIDED|95.0|41.2|65.79|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||65.79|41.20|<0.0001
73908145|NCT03633617|147346171|SUPERIORITY||LS Mean Difference|-12.32||||0.0004|TWO_SIDED|95.0|-19.107|-5.537|||ANCOVA||Dupilumab group vs. Placebo|||-5.537|-19.107|0.0004
73908146|NCT03633617|147346171|SUPERIORITY||LS Mean Difference|-0.51||||0.8393|TWO_SIDED|95.0|-5.423|4.406|||ANCOVA||Dupilumab group vs. Placebo|||4.406|-5.423|0.8393
73908147|NCT03633617|147346171|SUPERIORITY||LS Mean Difference|-9.92|||<|0.0001|TWO_SIDED|95.0|-14.811|-5.022|||ANCOVA||Dupilumab group vs. Placebo|||-5.022|-14.811|<0.0001
73908148|NCT03633617|147346172|SUPERIORITY||LS Mean Difference|-68.26|||<|0.0001|TWO_SIDED|95.0|-86.896|-49.615|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-49.615|-86.896|<0.0001
73908149|NCT03633617|147346172|SUPERIORITY||LS Mean Difference|-79.22|||<|0.0001|TWO_SIDED|95.0|-103.098|-55.338|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-55.338|-103.098|<0.0001
73908150|NCT03633617|147346172|SUPERIORITY||LS Mean Difference|-88.62|||<|0.0001|TWO_SIDED|95.0|-112.194|-65.046|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-65.046|-112.194|<0.0001
73908151|NCT03633617|147346173|SUPERIORITY||LS Mean Difference|-37.48||||0.0002|TWO_SIDED|95.0|-57.222|-17.745|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-17.745|-57.222|0.0002
73908152|NCT03633617|147346173|SUPERIORITY||LS Mean Difference|-4.35||||0.5243|TWO_SIDED|95.0|-17.734|9.038|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||9.038|-17.734|0.5243
73908153|NCT03633617|147346173|SUPERIORITY||LS Mean Difference|-22.89||||0.0008|TWO_SIDED|95.0|-36.272|-9.513|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-9.513|-36.272|0.0008
73908154|NCT03633617|147346174|SUPERIORITY||LS Mean Difference|-0.759|||<|0.0001|TWO_SIDED|95.0|-0.9061|-0.6127|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.6127|-0.9061|<0.0001
73908155|NCT03633617|147346174|SUPERIORITY||LS Mean Difference|-0.666|||<|0.0001|TWO_SIDED|95.0|-0.7773|-0.5538|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-0.5538|-0.7773|<0.0001
73908156|NCT03633617|147346174|SUPERIORITY||LS Mean Difference|-0.682|||<|0.0001|TWO_SIDED|95.0|-0.7929|-0.5707|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5707|-0.7929|<0.0001
73908157|NCT03633617|147346175|SUPERIORITY||LS Mean Difference|-0.741|||<|0.0001|TWO_SIDED|95.0|-0.8842|-0.5978|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5978|-0.8842|<0.0001
73908158|NCT03633617|147346175|SUPERIORITY||LS Mean Difference|-0.661|||<|0.0001|TWO_SIDED|95.0|-0.7674|-0.554|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-0.5540|-0.7674|<0.0001
73908159|NCT03633617|147346175|SUPERIORITY||LS Mean Difference|-0.672|||<|0.0001|TWO_SIDED|95.0|-0.7778|-0.5655|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5655|-0.7778|<0.0001
73908160|NCT03633617|147346176|SUPERIORITY||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.91|-1.84|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-1.84|-3.91|<0.0001
73908161|NCT03633617|147346176|SUPERIORITY||LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-4.86|-3.02|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-3.02|-4.86|<0.0001
73908162|NCT03633617|147346176|SUPERIORITY||LS Mean Difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.77|-2.93|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-2.93|-4.77|<0.0001
73908163|NCT03633617|147346177|SUPERIORITY||Difference in proportion|57.5|||<|0.0001|TWO_SIDED|95.0|41.69|73.33|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||73.33|41.69|<0.0001
73908164|NCT03633617|147346177|SUPERIORITY||Difference in proportion|72.4|||<|0.0001|TWO_SIDED|95.0|61.05|83.7|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||83.70|61.05|<0.0001
73908165|NCT03633617|147346177|SUPERIORITY||Difference in proportion|74.9|||<|0.0001|TWO_SIDED|95.0|64.25|85.5|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||85.50|64.25|<0.0001
73908166|NCT03633617|147346178|SUPERIORITY||Hodges-Lehmann estimator|-2.25|||<|0.0001|TWO_SIDED|95.0|-2.72|-1.73|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.7300|-2.7200|<0.0001
73908167|NCT03633617|147346178|SUPERIORITY||Hodges-Lehmann estimator|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.42|-1.11|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.1100|-2.4200|<0.0001
73908168|NCT03633617|147346178|SUPERIORITY||Hodges-Lehmann estimator|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.44|-1.15|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.1500|-2.4400|<0.0001
73908169|NCT03633617|147346179|SUPERIORITY||Hodges-Lehmann estimator|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.27|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.2700|-1.7400|<0.0001
73908170|NCT03633617|147346179|SUPERIORITY||Hodges-Lehmann estimator|-1.255|||<|0.0001|TWO_SIDED|95.0|-1.73|-1.05|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.0500|-1.7300|<0.0001
74085192|NCT01475487|147723996|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91||||0.701|TWO_SIDED|95.0|0.12|2.72|||Fisher Exact||This is the risk ratio for 1 vs 2 attempts|||2.72|0.12|0.701
73908171|NCT03633617|147346179|SUPERIORITY||Hodges-Lehmann estimator|-1.275|||<|0.0001|TWO_SIDED|95.0|-1.82|-1.07|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.0700|-1.8200|<0.0001
73908172|NCT03633617|147346180|SUPERIORITY||Difference in proportion|21.9||||0.0017|TWO_SIDED|95.0|9.42|34.38|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||34.38|9.42|0.0017
73908173|NCT03633617|147346180|SUPERIORITY||Difference in proportion|27.6|||<|0.0001|TWO_SIDED|95.0|17.2|38.09|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||38.09|17.20|<0.0001
73908174|NCT03633617|147346180|SUPERIORITY||Difference in proportion|28.9|||<|0.0001|TWO_SIDED|95.0|18.36|39.46|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||39.46|18.36|<0.0001
73908175|NCT03633617|147346181|SUPERIORITY||LS Mean Difference|-0.368||||0.0077|TWO_SIDED|95.0|-0.6388|-0.0975|||ANCOVA||Dupilumab group vs Placebo|||-0.0975|-0.6388|0.0077
73908176|NCT03633617|147346181|SUPERIORITY||LS Mean Difference|-0.015||||0.8586|TWO_SIDED|95.0|-0.1782|0.1485|||ANCOVA||Dupilumab group vs. Placebo|||0.1485|-0.1782|0.8586
73908177|NCT03633617|147346181|SUPERIORITY||LS Mean Difference|-0.309||||0.0002|TWO_SIDED|95.0|-0.4703|-0.1471|||ANCOVA||Dupilumab group vs. Placebo|||-0.1471|-0.4703|0.0002
73908178|NCT03633617|147346182|SUPERIORITY||LS Mean Difference|-2.0||||0.0467|TWO_SIDED|95.0|-3.87|-0.03|||ANCOVA||Dupilumab group vs. Placebo|||-0.03|-3.87|0.0467
73908179|NCT03633617|147346182|SUPERIORITY||LS Mean Difference|-0.5||||0.5469||95.0|-2.03|1.08|||ANCOVA||Dupilumab group vs. Placebo|||1.08|-2.03|0.5469
73908180|NCT03633617|147346182|SUPERIORITY||LS Mean Difference|-1.5||||0.0718|TWO_SIDED|95.0|-3.0|0.13|||ANCOVA||Dupilumab group vs. Placebo|||0.13|-3.0|0.0718
73908181|NCT03633617|147346183|SUPERIORITY||LS Mean Difference|-1.7||||0.0051|TWO_SIDED|95.0|-2.93|-0.52|||ANCOVA||Dupilumab group vs. Placebo|||-0.52|-2.93|0.0051
73908182|NCT03633617|147346183|SUPERIORITY||LS Mean Difference|-0.5||||0.3152|TWO_SIDED|95.0|-1.38|0.44|||ANCOVA||Dupilumab group vs. Placebo|||0.44|-1.38|0.3152
74085193|NCT01475487|147723997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.6||||0.043|TWO_SIDED|95.0|0.79|39.48|||Fisher Exact|||Comparison for Grade 3-4||39.48|0.79|0.043
73856873|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.43||||0.953|TWO_SIDED|95.0|-13.8|14.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.65|-13.80|0.953
73856874|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.48||||0.731|TWO_SIDED|95.0|-16.63|11.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.66|-16.63|0.731
73856875|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-22.63||||0.024|TWO_SIDED|95.0|-39.97|-5.29||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-5.29|-39.97|0.024
73856876|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-26.87||||0.009|TWO_SIDED|95.0|-44.12|-9.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-9.62|-44.12|0.009
73856877|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-30.76||||0.003|TWO_SIDED|95.0|-48.36|-13.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-13.16|-48.36|0.003
73856878|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-27.26||||0.007|TWO_SIDED|95.0|-44.51|-10.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-10.00|-44.51|0.007
73856879|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|4.66||||0.516|TWO_SIDED|95.0|-9.5|18.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.82|-9.50|0.516
73908183|NCT03633617|147346183|SUPERIORITY||LS Mean Difference|-1.4||||0.0037|TWO_SIDED|95.0|-2.3|0.45|||ANCOVA||Dupilumab group vs. Placebo|||0.45|-2.30|0.0037
73856880|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.55||||0.939|TWO_SIDED|95.0|-13.63|14.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.72|-13.63|0.939
73856881|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.53||||0.536|TWO_SIDED|95.0|-18.86|9.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.80|-18.86|0.536
73856882|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-15.81||||0.107|TWO_SIDED|95.0|-33.02|1.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.41|-33.02|0.107
73856883|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-23.71||||0.019|TWO_SIDED|95.0|-40.91|-6.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-6.51|-40.91|0.019
73856884|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-28.44||||0.006|TWO_SIDED|95.0|-45.99|-10.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-10.88|-45.99|0.006
73856885|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-25.04||||0.012|TWO_SIDED|95.0|-42.23|-7.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-7.85|-42.23|0.012
73908184|NCT03633617|147346184|SUPERIORITY||Difference in proportion|-12.7||||0.017|TWO_SIDED|95.0|-23.21|-2.26|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||-2.26|-23.21|0.0170
73908185|NCT03633617|147346184|SUPERIORITY||Difference in proportion|-1.3||||0.5493|TWO_SIDED|95.0|-5.51|2.93|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||2.93|-5.51|0.5493
73908186|NCT03633617|147346184|SUPERIORITY||Difference in proportion|0.0||||0.9887|TWO_SIDED|95.0|-4.9|5.02|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||5.02|-4.9|0.9887
73964479|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.007|TWO_SIDED|95.0|-1.3|-0.2|||t-test, 2 sided|||Week 12, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.2|-1.3|0.007
73964480|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.214|TWO_SIDED|95.0|-1.1|0.3|||t-test, 2 sided|||Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo.||0.3|-1.1|0.214
73964481|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.003|TWO_SIDED|95.0|-1.5|-0.3|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.3|-1.5|0.003
74025973|NCT02243176|147604986|NON_INFERIORITY_OR_EQUIVALENCE|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.7809|TWO_SIDED|95.0|-0.21|0.15||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA\< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA\< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."||0.15|-0.21|0.7809
74025974|NCT02243176|147604987|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.12|0.39|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c \< 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose|||0.39|0.12|<0.0001
74025975|NCT02243176|147604988|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.5044|TWO_SIDED|95.0|0.74|1.15|||Cochran-Mantel-Haenszel|stratefied by baseline disease severity (HbA1c\<8%, \>=8%)||||1.15|0.74|0.5044
74025976|NCT02243176|147604989|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.28||||0.0518|TWO_SIDED|95.0|0.98|1.67|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c \< 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose|||1.67|0.98|0.0518
73856886|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.16||||0.195|TWO_SIDED|95.0|-4.75|23.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.08|-4.75|0.195
73964482|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-7.8|-2.2|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||-2.2|-7.8|<0.001
74025977|NCT02243176|147604990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.18||0.8915|TWO_SIDED|95.0|-0.33|0.38|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|||0.38|-0.33|0.8915
73856887|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.48||||0.835|TWO_SIDED|95.0|-12.54|15.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.50|-12.54|0.835
73856888|NCT01559259|147258992|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.41||||0.542|TWO_SIDED|95.0|-18.61|9.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.79|-18.61|0.542
73856889|NCT01559259|147258993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||1.01|0.79|<0.001
73856890|NCT01559259|147258993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.83|||<|0.001|TWO_SIDED|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||1.01|0.79|< 0.001
73856891|NCT01559259|147258993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.86|||<|0.001|TWO_SIDED|95.0|0.73|0.99||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.99|0.73|< 0.001
73964483|NCT01037985|147464610|SUPERIORITY||Mean Difference (Net)|0.1||||0.673|TWO_SIDED|95.0|-0.5|0.7|||t-test, 2 sided|||Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo.||0.7|-0.5|0.673
73964484|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.276|TWO_SIDED|95.0|-0.3|1.1|||t-test, 2 sided|||Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo.||1.1|-0.3|0.276
73964485|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||0.5|-0.7|0.670
73964486|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.5|0.5|||t-test, 2 sided|||Week 24, Relief: Comparison within the participant between EXC 001 and placebo.||0.5|-0.5|1.000
73964487|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.909|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||Week 24, Pliability: Comparison within the participant between EXC 001 and placebo.||0.6|-0.5|0.909
73964488|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.852|TWO_SIDED|95.0|-0.6|0.8|||t-test, 2 sided|||Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo.||0.8|-0.6|0.852
73908187|NCT02758171|147346224|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|101.71|STANDARD_DEVIATION|5.8|<|0.0001|TWO_SIDED|90.0|99.818|103.644|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.644|99.818|<0.0001
73908188|NCT02758171|147346225|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|99.39|STANDARD_DEVIATION|13.1|<|0.0001|TWO_SIDED|90.0|95.29|103.672|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.672|95.290|<0.0001
73908189|NCT02758171|147346226|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|102.33|STANDARD_DEVIATION|13.6|<|0.0001|TWO_SIDED|90.0|97.945|106.91|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||106.910|97.945|<0.0001
73908190|NCT02758171|147346227|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|107.51|STANDARD_DEVIATION|27.4||0.0027|TWO_SIDED|90.0|98.561|117.282|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||117.282|98.561|0.0027
73908191|NCT02758171|147346228|SUPERIORITY_OR_OTHER||Adjusted geometric mean (gMean) ratio|101.44|STANDARD_DEVIATION|5.7|||TWO_SIDED|90.0|99.574|103.336|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.336|99.574|
73964489|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.906|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||0.6|-0.5|0.906
73964490|NCT01037985|147464610|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.768|TWO_SIDED|95.0|-2.8|3.8|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||3.8|-2.8|0.768
73964491|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.773|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided|||Week 12 Pain: Comparison within the participant between EXC 001 and placebo.||0.5|-0.4|0.773
73964492|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|||Week 12, Itching: Comparison within the participant between EXC 001 and placebo.||0.4|-0.4|1.000
73964493|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.072|TWO_SIDED|95.0|-1.4|0.1|||t-test, 2 sided|||Week 12, Color: Comparison within the participant between EXC 001 and placebo.||0.1|-1.4|0.072
73964494|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.851|TWO_SIDED|95.0|-0.7|0.6|||t-test, 2 sided|||Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.6|-0.7|0.851
73964495|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.184|TWO_SIDED|95.0|-1.2|0.2|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||0.2|-1.2|0.184
73964496|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.059|TWO_SIDED|95.0|-1.3|0.0|||t-test, 2 sided|||Week 12, Irregular: Comparison within the participant between EXC 001 and placebo.||0.0|-1.3|0.059
73964497|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.04|TWO_SIDED|95.0|-1.5|0.0|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.0|-1.5|0.040
73964498|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.12|TWO_SIDED|95.0|-4.1|0.5|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||0.5|-4.1|0.120
73964499|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.094|TWO_SIDED|95.0|-4.0|0.3|||t-test, 2 sided|||Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||0.3|-4.0|0.094
73964500|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.243|TWO_SIDED|95.0|-0.2|0.6|||t-test, 1 sided|||Week 24, Pain: Comparison within the participant between EXC 001 and placebo.||0.6|-0.2|0.243
73964501|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.339|TWO_SIDED|95.0|-0.2|0.6|||t-test, 2 sided|||Week 24, Itching: Comparison within the participant between EXC 001 and placebo.||0.6|-0.2|0.339
73964502|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.25|TWO_SIDED|95.0|-0.3|1.2|||t-test, 2 sided|||Week 24, Color: Comparison within the participant between EXC 001 and placebo.||1.2|-0.3|0.250
73908192|NCT02758171|147346229|SUPERIORITY_OR_OTHER||Adjusted geometric mean (gMean) ratio|98.15|STANDARD_DEVIATION|15.2|||TWO_SIDED|90.0|93.456|103.082|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.082|93.456|
73908193|NCT02038881|147346262|OTHER||GMT Ratio (Group 1 / Group 2) at Week 4|0.851|||||TWO_SIDED|95.0|0.258|2.8||||||||2.800|0.258|
73856892|NCT01559259|147258993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.65|0.95||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.95|0.65|< 0.001
73856893|NCT01559259|147258993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15||||0.174|TWO_SIDED|95.0|-0.07|0.37||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.37|-0.07|0.174
73856894|NCT01559259|147258993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.722|TWO_SIDED|95.0|-0.18|0.26||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.26|-0.18|0.722
73856895|NCT01559259|147258993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.365|TWO_SIDED|95.0|-0.32|0.11||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.11|-0.32|0.365
73856896|NCT02019108|147259031|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.495|TWO_SIDED|95.0|-1.1|0.5||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.5|-1.1|0.495
73856897|NCT02019108|147259031|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.079|TWO_SIDED|95.0|-1.6|0.1||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.1|-1.6|0.079
73856898|NCT02019108|147259032|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.117|TWO_SIDED|95.0|-2.6|0.3||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.3|-2.6|0.117
73856899|NCT02019108|147259032|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.133|TWO_SIDED|95.0|-2.5|0.3||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.3|-2.5|0.133
73856900|NCT02019108|147259033|SUPERIORITY||Median Difference (Final Values)|-0.14||||0.125|TWO_SIDED|95.0|-0.31|0.04||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks||0.04|-0.31|0.125
73856901|NCT02019108|147259033|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.103|TWO_SIDED|95.0|-0.37|0.03||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks||0.03|-0.37|0.103
73856902|NCT02019108|147259034|SUPERIORITY||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.12||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-0.12|-0.39|<0.001
73856903|NCT02019108|147259034|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.056|TWO_SIDED|95.0|-0.4|0.01||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.01|-0.40|0.056
73856904|NCT02019108|147259035|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.031|TWO_SIDED|95.0|-0.11|-0.01||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-0.01|-0.11|0.031
73856905|NCT02019108|147259035|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.058|TWO_SIDED|95.0|-0.12|0.0||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.00|-0.12|0.058
73856906|NCT02019108|147259036|SUPERIORITY||Mean Difference (Final Values)|-9.04|||<|0.001|TWO_SIDED|95.0|-11.22|-6.86||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-6.86|-11.22|<0.001
73856907|NCT02019108|147259036|SUPERIORITY||Mean Difference (Final Values)|-6.78|||<|0.001|TWO_SIDED|95.0|-8.82|-4.75||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||-4.75|-8.82|<0.001
73856908|NCT02019108|147259037|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.111|TWO_SIDED|95.0|-8.3|0.9||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.9|-8.3|0.111
73856909|NCT02019108|147259037|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.232|TWO_SIDED|95.0|-7.3|1.8||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||1.8|-7.3|0.232
73908194|NCT02038881|147346262|OTHER||GMT Ratio (Group 1 / Group 2) at Week 6|0.653|||||TWO_SIDED|95.0|0.319|1.333||||||||1.333|0.319|
73908195|NCT02038881|147346262|OTHER||GMT Ratio (Group 1 / Group 2) at Week 30|1.126|||||TWO_SIDED|95.0|0.291|4.352||||||||4.352|0.291|
73908196|NCT02038881|147346262|OTHER||GMT Ratio (Group 1 / Group 2) at Week 56|0.916|||||TWO_SIDED|95.0|0.22|3.819||||||||3.819|0.220|
73908197|NCT02038881|147346262|OTHER||GMT Ratio (Group 3 / Group 1) at Week 4|1.045|||||TWO_SIDED|95.0|0.292|3.741||||||||3.741|0.292|
73908198|NCT02038881|147346262|OTHER||GMT Ratio (Group 3 / Group 1) at Week 6|1.315|||||TWO_SIDED|95.0|0.598|2.892||||||||2.892|0.598|
73908199|NCT02038881|147346263|OTHER||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.762|||||TWO_SIDED|95.0|0.385|1.507||||||||1.507|0.385|
73908200|NCT02038881|147346264|OTHER||GMT Ratio (Group 1 [W6]/ Group 3 [W14)|0.347|||||TWO_SIDED|95.0|0.2|0.603||||||||0.603|0.200|
73908201|NCT02038881|147346264|OTHER||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.532|||||TWO_SIDED|95.0|0.285|0.992||||||||0.992|0.285|
73908202|NCT02038881|147346265|OTHER||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|4.138|||||TWO_SIDED|95.0|1.241|13.793||||||||13.793|1.241|
73908203|NCT02038881|147346265|OTHER||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|4.608|||||TWO_SIDED|95.0|1.365|15.558||||||||15.558|1.365|
73908204|NCT02038881|147346265|OTHER||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.215|||||TWO_SIDED|95.0|0.066|0.699||||||||0.699|0.066|
73908205|NCT02038881|147346265|OTHER||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.237|||||TWO_SIDED|95.0|0.072|0.782||||||||0.782|0.072|
73908206|NCT02038881|147346266|OTHER||GMT Ratio (Group 1 / Group 2) at Week 4|0.823|||||TWO_SIDED|95.0|0.333|2.038||||||||2.038|0.333|
73908207|NCT02038881|147346266|OTHER||GMT Ratio (Group 1 / Group 2) at Week 6|0.787|||||TWO_SIDED|95.0|0.41|1.508||||||||1.508|0.410|
73908208|NCT02038881|147346266|OTHER||GMT Ratio (Group 1 / Group 2) at Week 30|0.535|||||TWO_SIDED|95.0|0.187|1.536||||||||1.536|0.187|
73908209|NCT02038881|147346266|OTHER||GMT Ratio (Group 1 / Group 2) at Week 56|0.59|||||TWO_SIDED|95.0|0.203|1.716||||||||1.716|0.203|
73908210|NCT02038881|147346266|OTHER||GMT Ratio (Group 3 / Group 1) at Week 4|2.557|||||TWO_SIDED|95.0|0.972|6.731||||||||6.731|0.972|
73908211|NCT02038881|147346266|OTHER||GMT Ratio (Group 3 / Group 1) at Week 6|1.215|||||TWO_SIDED|95.0|0.612|2.412||||||||2.412|0.612|
73908212|NCT02038881|147346267|OTHER||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.878|||||TWO_SIDED|95.0|0.48|1.606||||||||1.606|0.480|
73908213|NCT02038881|147346268|OTHER||GMT ratio (Group 1 [W6]/ Group 3 [W14)|0.281|||||TWO_SIDED|95.0|0.146|0.542||||||||0.542|0.146|
73908214|NCT02038881|147346268|OTHER||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.357|||||TWO_SIDED|95.0|0.178|0.718||||||||0.718|0.178|
73908215|NCT02038881|147346269|OTHER||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|6.727|||||TWO_SIDED|95.0|2.493|18.15||||||||18.150|2.493|
73908216|NCT02038881|147346269|OTHER||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|7.275|||||TWO_SIDED|95.0|2.693|19.649||||||||19.649|2.693|
73908217|NCT02038881|147346269|OTHER||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.278|||||TWO_SIDED|95.0|0.115|0.672||||||||0.672|0.115|
73908218|NCT02038881|147346269|OTHER||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.233|||||TWO_SIDED|95.0|0.1|0.541||||||||0.541|0.100|
73908219|NCT02038881|147346270|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-7.6|||||TWO_SIDED|95.0|-34.1|17.9||||||||17.9|-34.1|
73908220|NCT02038881|147346270|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||TWO_SIDED|95.0|-16.8|16.3||||||||16.3|-16.8|
73908221|NCT02038881|147346270|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 30|5.1|||||TWO_SIDED|95.0|-24.5|32.6||||||||32.6|-24.5|
73908222|NCT02038881|147346270|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-1.5|||||TWO_SIDED|95.0|-31.5|29.2||||||||29.2|-31.5|
73908223|NCT02038881|147346270|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 4|-5.8|||||TWO_SIDED|95.0|-32.8|22.2||||||||22.2|-32.8|
73908224|NCT02038881|147346270|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-7.7|||||TWO_SIDED|95.0|-25.1|10.1||||||||10.1|-25.1|
73908225|NCT02038881|147346271|OTHER||Difference in seroconversion rates (%)|-4.3|||||TWO_SIDED|95.0|-15.2|11.6||||||||11.6|-15.2|
73908226|NCT02038881|147346272|OTHER||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-17.1|13.4||||||||13.4|-17.1|
73908227|NCT02038881|147346272|OTHER||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-16.2|13.4||||||||13.4|-16.2|
73908228|NCT02038881|147346273|OTHER||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|5.6|||||TWO_SIDED|95.0|-19.6|33.0||||||||33.0|-19.6|
73908229|NCT02038881|147346273|OTHER||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|16.7|||||TWO_SIDED|95.0|-11.0|44.4||||||||44.4|-11.0|
73908230|NCT02038881|147346273|OTHER||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-10.6|||||TWO_SIDED|95.0|-35.6|14.3||||||||14.3|-35.6|
73908231|NCT02038881|147346273|OTHER||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-15.2|||||TWO_SIDED|95.0|-40.5|10.5||||||||10.5|-40.5|
73908232|NCT02038881|147346274|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-9.6|||||TWO_SIDED|95.0|-38.4|20.3||||||||20.3|-38.4|
73908233|NCT02038881|147346274|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||TWO_SIDED|95.0|-16.8|16.3||||||||16.3|-16.8|
73908234|NCT02038881|147346274|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 30|-9.6|||||TWO_SIDED|95.0|-38.4|17.6||||||||17.6|-38.4|
73908235|NCT02038881|147346274|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-6.1|||||TWO_SIDED|95.0|-35.6|23.7||||||||23.7|-35.6|
73908236|NCT02038881|147346274|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 4|20.8|||||TWO_SIDED|95.0|-7.7|47.8||||||||47.8|-7.7|
73908237|NCT02038881|147346274|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-3.8|||||TWO_SIDED|95.0|-20.5|13.4||||||||13.4|-20.5|
73908238|NCT02038881|147346275|OTHER||Difference in seroconversion rates (%)|-2.2|||||TWO_SIDED|95.0|-12.0|13.2||||||||13.2|-12.0|
73908239|NCT02038881|147346276|OTHER||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-17.1|13.4||||||||13.4|-17.1|
73908240|NCT02038881|147346276|OTHER||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-16.2|13.4||||||||13.4|-16.2|
73908241|NCT02038881|147346277|OTHER||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|19.4|||||TWO_SIDED|95.0|-4.5|45.8||||||||45.8|-4.5|
73908242|NCT02038881|147346277|OTHER||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|29.2|||||TWO_SIDED|95.0|5.8|55.4||||||||55.4|5.8|
74025978|NCT02243176|147604991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.249||0.2248|TWO_SIDED|95.0|-0.186|0.791|||ANCOVA||Mean difference=Saxagliptin - Acarbose|||0.791|-0.186|0.2248
73856910|NCT02019108|147259038|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.462|TWO_SIDED|95.0|-0.36|0.78||a priori threshold for significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.78|-0.36|0.462
74025979|NCT02243176|147604992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.48|STANDARD_ERROR_OF_MEAN|8.407||0.3739|TWO_SIDED|95.0|-9.039|24.005|||ANCOVA||Mean difference=Saxagliptin - Acarbose|||24.005|-9.039|0.3739
74025980|NCT02243176|147604993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.26||0.0078|TWO_SIDED|95.0|0.18|1.19|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|||1.19|0.18|0.0078
74085194|NCT02426541|147724004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68||||0.3794|TWO_SIDED|95.0|-2.18|5.54|||ANCOVA|Adjusted for sex and baseline||||5.54|-2.18|0.3794
74085195|NCT02426541|147724005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.5317|TWO_SIDED|95.0|-5.6|2.96|||ANCOVA|Adjusted for sex and baseline||||2.96|-5.60|0.5317
74085196|NCT02426541|147724006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003||||0.9984|TWO_SIDED|95.0|-3.07|3.07|||ANCOVA|Adjusted for sex and baseline||||3.07|-3.07|0.9984
73856911|NCT02019108|147259038|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.737|TWO_SIDED|95.0|-0.76|0.54||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.54|-0.76|0.737
73856912|NCT02019108|147259039|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.876|TWO_SIDED|95.0|-0.5|0.43||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.43|-0.50|0.876
73856913|NCT02019108|147259039|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.897|TWO_SIDED|95.0|-0.43|0.49||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.49|-0.43|0.897
73856914|NCT01466660|147259070|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.822||||0.0891|TWO_SIDED|95.0|0.655|1.032||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by Epidermal Growth Factor Receptor (EGFR) mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.||1.032|0.655|0.0891
73856915|NCT01466660|147259071|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.0136|TWO_SIDED|95.0|0.595|0.944||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||0.944|0.595|0.0136
73856916|NCT01466660|147259072|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.862||||0.2343|TWO_SIDED|95.0|0.674|1.101||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.||1.101|0.674|0.2343
73856917|NCT01466660|147259073|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.307||||0.3235|TWO_SIDED|95.0|0.768|2.223||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||2.223|0.768|0.3235
73856918|NCT01466660|147259076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.138||||0.7856|TWO_SIDED|95.0|0.447|2.896||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||2.896|0.447|0.7856
73856919|NCT01466660|147259078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.45|STANDARD_ERROR_OF_MEAN|1.87||0.0657|TWO_SIDED|95.0|-7.13|0.23||p-value was not adjusted for multiple comparisons|ANCOVA|Adjusted for baseline sum of diameters, EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|Exploratory trial, no formal hypotheses were tested.||0.23|-7.13|0.0657
73856920|NCT01466660|147259079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.017||0.1422|TWO_SIDED|95.0|-0.06|0.01||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|"EQ-5D UK utility score.~Exploratory trial, no formal hypotheses were tested."||0.01|-0.06|0.1422
73856921|NCT01466660|147259079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.054|TWO_SIDED|95.0|-0.06|0.0||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-5D Belgium utility score.~Exploratory trial, no formal hypotheses were tested."||0.00|-0.06|0.0540
73856922|NCT01466660|147259079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.21||0.2032|TWO_SIDED|95.0|-3.9|0.8||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-VAS utility score.~Exploratory trial, no formal hypotheses were tested."||0.8|-3.9|0.2032
73856923|NCT00191724|147259081|SUPERIORITY_OR_OTHER|||||||0.528||95.0||||P-value for effect of drotrecogin alfa (activated) dose in right ventricular function at Day 6|Regression, Linear|||||||0.528
73856924|NCT00191724|147259081|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||P-value for effect of drotrecogin alfa (activated) dose on right ventricular function at Day 90|Regression, Linear|||||||0.230
73856925|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Dyspnea 90-Day Follow-Up.|Regression, Linear|||||||0.018
73856926|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value for Emotional 90 Day Follow-up.|Regression, Linear|||||||0.720
74085197|NCT04412057|147724007|SUPERIORITY||Odds Ratio (OR)|2.86||||0.044|TWO_SIDED|90.0|1.04|7.88|||Regression, Logistic|||The sample size provided greater than 80% power to detect a difference of 0.25 in the proportion of subjects alive and free of respiratory failure using a Chi-square exact test at a one-sided significance level of 0.05. This calculation assumed that the proportion alive and free of respiratory failure will be 0.60 in the placebo group and 0.85 in the CERC-002 group.||7.88|1.04|0.0440
74085198|NCT04412057|147724008|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1762|TWO_SIDED|90.0|0.59|6.82|||Regression, Logistic|||The proportion of subjects alive at Day 28/ET in the CERC-002 group was compared to that in the placebo group using logistic regression methods. The logistic regression model included terms for treatment group. Model based point estimate (i.e., odds ratio \[OR\]), 90% confidence interval \[CI\], and one-sided p-value were reported.||6.82|0.59|0.1762
74085199|NCT02156154|147724009|SUPERIORITY||Median Difference (Final Values)|-0.04||||0.29|TWO_SIDED|95.0|-0.18|0.11||significance criterion of P \< .044.|Wilcoxon (Mann-Whitney)||Difference = IV Acetaminophen - Placebo group|A total of 28 patients (5%) were missing monitoring data (14 patients in each group). Values for these patients were obtained using multivariable imputation with 5 imputation data sets. The imputation regression model included all of the baseline, intraoperative, surgical, and postanesthesia care unit variables and all of the secondary outcomes||0.11|-0.18|0.29
73908243|NCT02038881|147346277|OTHER||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-9.8|||||TWO_SIDED|95.0|-33.0|11.7||||||||11.7|-33.0|
73908244|NCT02038881|147346277|OTHER||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-23.1|||||TWO_SIDED|95.0|-46.7|-1.0||||||||-1.0|-46.7|
73908245|NCT01453725|147346288|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|31.2|||<|0.0001|TWO_SIDED|95.0|17.5|43.6||Stratification factors: Baseline evidence of sacroiliitis on magnetic resonance imaging (MRI) and Screening C-reactive protein (CRP) level|Stratified Miettinen and Nurminen Method|||||43.6|17.5|<0.0001
73908246|NCT01453725|147346289|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|33.8|||<|0.0001|TWO_SIDED|95.0|20.4|46.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||46.1|20.4|<0.0001
73908247|NCT01453725|147346290|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|28.0|||<|0.0001|TWO_SIDED|95.0|14.4|40.6||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||40.6|14.4|<0.0001
73908248|NCT01453725|147346291|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|15.2||||0.0136|TWO_SIDED|95.0|3.2|27.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||27.1|3.2|0.0136
73964503|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.164|TWO_SIDED|95.0|-1.3|0.2|||t-test, 2 sided|||Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.2|-1.3|0.164
73964504|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.8|0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||0.8|-0.8|1.000
73964505|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.928|TWO_SIDED|95.0|-0.8|0.7|||t-test, 2 sided|||Week 24, Irregular: Comparison within the participant between EXC 001 and placebo.||0.7|-0.8|0.928
73964506|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.865|TWO_SIDED|95.0|-0.8|0.7|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||0.7|-0.8|0.865
73964507|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.804|TWO_SIDED|95.0|-2.3|3.0|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||3.0|-2.3|0.804
73964508|NCT01037985|147464611|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.937|TWO_SIDED|95.0|-2.6|2.4|||t-test, 2 sided|||Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||2.4|-2.6|0.937
73964509|NCT02269475|147464618|SUPERIORITY_OR_OTHER||Vaccine efficacy (%)|100.0|||||TWO_SIDED|95.0|-1875.3|100.0||"No statistical tests were used, instead the confidence interval was used for showing superiority.~If lower bound of the 95% CI is greater than 0%, the efficacy of MEDI3250 is demonstrated."|Exact conditional method|Estimated by an exact conditional method in total number of cases which follows a Poisson assumption.|Vaccine efficacy (%) = (1-RR)\*100 where RR = Risk Reduction.|||100.0|-1875.3|
73964510|NCT02269475|147464619|SUPERIORITY_OR_OTHER||Vaccine efficacy (%)|27.5|||||TWO_SIDED|95.0|7.4|43.0||"No statistical tests were used, instead the confidence interval was used for showing superiority.~If lower bound of the 95% CI is greater than 0%, the efficacy of MEDI3250 is demonstrated."|Exact conditional method|Estimated by an exact conditional method in total number of cases which follows a Poisson assumption.|Vaccine efficacy (%) = (1-RR)\*100 where RR = Risk Reduction.|||43.0|7.4|
73964511|NCT02730871|147464621|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.342|<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||ANCOVA|||||-1.5|-2.8|<0.001
73964512|NCT02730871|147464622|OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.342|<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||ANCOVA|||||-1.5|-2.8|<0.001
73964513|NCT02730871|147464623|OTHER||Mean Difference (Final Values)|-9.98|STANDARD_ERROR_OF_MEAN|1.572|<|0.001|TWO_SIDED|95.0|-13.1|-6.9|||ANCOVA|||||-6.9|-13.1|<0.001
73964514|NCT02730871|147464624|OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.576||0.022|TWO_SIDED|95.0|-2.5|-0.2|||Repeated measures model|||Change from Baseline in IOP at 9:00||-0.2|-2.5|0.022
73964515|NCT02730871|147464624|OTHER||Mean Difference (Final Values)|-2.85|STANDARD_ERROR_OF_MEAN|0.506|<|0.001|TWO_SIDED|95.0|-3.9|-1.9|||Repeated measures model|||Change from Baseline in IOP at 11:00||-1.9|-3.9|<0.001
73964516|NCT02730871|147464625|OTHER||Mean Difference (Final Values)|-6.15|STANDARD_ERROR_OF_MEAN|2.567||0.018|TWO_SIDED|95.0|-11.2|-1.1|||Repeated measures model|||Percentage Change from Baseline in IOP at 09:00||-1.1|-11.2|0.018
73964517|NCT02730871|147464625|OTHER||Mean Difference (Final Values)|-13.21|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|-17.8|-8.6|||Repeated measures model|||Percentage Change from Baseline in IOP at 11:00||-8.6|-17.8|<0.001
74085200|NCT02156154|147724010|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.07|TWO_SIDED|99.4|-0.71|0.15||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|||0.15|-0.71|0.07
73908249|NCT01453725|147346292|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mann-Whitney Test|||||||<0.0001
73908250|NCT00178633|147346306|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
73908251|NCT02664610|147346319|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
73908252|NCT02664610|147346320|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
73908253|NCT01967342|147346338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.268|STANDARD_ERROR_OF_MEAN|-0.193||0.165|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between pre-treatment and 10-week post-treatment.||||.165
73908254|NCT01967342|147346338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245|STANDARD_ERROR_OF_MEAN|0.198||0.216|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between post-treatment and 6-month follow-up.||||.216
73908255|NCT01967342|147346338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.052|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the pre-treatment and 10-week post-treatment.||||< .001
74025981|NCT03063385|147604996|OTHER|\[Not specified\]|Slope|0.0153|STANDARD_ERROR_OF_MEAN|0.0067||0.0229|TWO_SIDED|95.0|0.0022|0.0285||Statistical significance taken at the 0.05 level|GEE modeling|P-value \& estimate rely on group x time interaction effect on primary outcome when controlling for self-efficacy. Used modified Baron \& Kenny method|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for self-efficacy as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0285|0.0022|.0229
74085201|NCT02156154|147724011|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.46|TWO_SIDED|99.4|-0.51|0.29||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|||0.29|-0.51|0.46
73856927|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.481||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.481
73856928|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.161
73856929|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.068
73908256|NCT01967342|147346338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.361|STANDARD_ERROR_OF_MEAN|0.199||0.07|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the post-treatment and 6-month follow-up.||||.070
73908257|NCT01967342|147346338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.823|STANDARD_ERROR_OF_MEAN|0.191|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
73908258|NCT01967342|147346338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.203||0.519|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the post-treatment and 6-month follow-up.||||.519
73908259|NCT01967342|147346339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.247||0.196|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the pre-treatment and 10-week post-treatment.||||.196
73908260|NCT01967342|147346339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.182|STANDARD_ERROR_OF_MEAN|0.239||0.447|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the post-treatment and 6-month follow-up.||||.447
73856930|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.985
73856931|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value for Fatigue 90 Day Follow-Up|Regression, Linear|||||||0.281
73856932|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value for Mastery 90 Day Follow-Up|Regression, Linear|||||||0.273
73908261|NCT01967342|147346339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.643|STANDARD_ERROR_OF_MEAN|0.241|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the pre-treatment and 10-week post-treatment.||||<.001
73908262|NCT01967342|147346339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.548|STANDARD_ERROR_OF_MEAN|0.237||0.021|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the post-treatment and 6-month follow-up.||||.021
73908263|NCT01967342|147346339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.999|STANDARD_ERROR_OF_MEAN|0.244|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
73908264|NCT01967342|147346339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.243||0.305|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the post-treatment and 6-month follow-up.||||.305
73908265|NCT01967342|147346340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.086|STANDARD_ERROR_OF_MEAN|0.623||0.082|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the pre-treatment and 10-week post-treatment.||||.082
73908266|NCT01967342|147346340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.532||0.652|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the post-treatment and 6-month follow-up.||||.652
73908267|NCT01967342|147346340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.416|STANDARD_ERROR_OF_MEAN|0.612|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the pre-treatment and 10-week post-treatment.||||< .001
74025982|NCT03063385|147604996|OTHER|\[Not specified\]|Slope|0.0151|STANDARD_ERROR_OF_MEAN|0.0067||0.0249|TWO_SIDED|95.0|0.0019|0.0282||Statistical significance taken at the 0.05 level|GEE modeling|P-value and estimate rely on group x time interaction effect on primary outcome when controlling for sexual communication attitudes. Same method B\&K|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for sexual communication attitudes as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0282|0.0019|0.0249
74025983|NCT03063385|147604996|OTHER|\[Not specified\]|Slope|0.0158|STANDARD_ERROR_OF_MEAN|0.0068||0.0204|TWO_SIDED|95.0|0.0025|0.0292||Statistical significance taken at the 0.05 level|GEE modeling|Reported P-value and estimate rely on the group x time interaction effect on primary outcome when controlling for subjective norms. Same method B\&K|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for subjective norms as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0292|0.0025|0.0204
74025984|NCT03518840|147605017|SUPERIORITY||Mean Difference (Final Values)|-1.9615|STANDARD_ERROR_OF_MEAN|0.3329|<|0.001|TWO_SIDED|95.0|-2.6299|-1.2932|||paired t-test, 2 sided|||The null hypothesis is that there is no change in the baseline ASLR score following four weeks of SIJ belt therapy.||-1.2932|-2.6299|<.001
74025985|NCT03518840|147605018|SUPERIORITY||Median Difference (Final Values)|-1.9474|STANDARD_ERROR_OF_MEAN|0.3353|<|0.001|TWO_SIDED|95.0|-2.619|-1.2757|||paired t-test, 2 sided|||The null hypothesis is that there is no change in the baseline NRS score following four weeks of SIJ belt therapy.||-1.2757|-2.6190|<.001
74025986|NCT03704051|147605019|EQUIVALENCE|A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.||||||0.634|||||||Mixed Models Analysis|All models adjusted for order of conditions, time since last feeding and infant age.||||||0.634
73856933|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.848
73856934|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.841||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.841
73856935|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.797
73856936|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.963
73856937|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.149
73856938|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.141||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.141
73856939|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.774
73856940|NCT00191724|147259082|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.394
73908268|NCT01967342|147346340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.619|STANDARD_ERROR_OF_MEAN|0.528||0.241|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the post-treatment and 6-month follow-up.||||.241
73856941|NCT02301546|147259087|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
73856942|NCT04838054|147259088|SUPERIORITY||Mean Difference (Net)|0.27||||0.28|TWO_SIDED|||||p-values \<0.05 means statistically significant|ANCOVA|||||||0.28
73856943|NCT04838054|147259089|SUPERIORITY||Mean Difference (Net)|0.41||||0.011|TWO_SIDED|||||p\<0.05 means statistically significant|ANCOVA|||||||0.011
73856944|NCT04838054|147259090|SUPERIORITY||Mean Difference (Net)|2.99|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
73856945|NCT02447250|147259098|OTHER|||||||0.14|||||||Chi-squared|||comparison of mean birth weights between responders and non-responders||||0.14
73856946|NCT02447250|147259099|OTHER|||||||0.16|||||||Chi-squared|||||||0.16
73856947|NCT02447250|147259100|OTHER|||||||1|||||||Fisher Exact|||||||1.0
73856948|NCT02447250|147259102|OTHER|||||||1|||||||Chi-squared|||||||1.0
73856949|NCT02447250|147259103|OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
73856950|NCT00396006|147259119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0195|||||||Wilcoxon signed rank test|||||||0.0195
73856951|NCT00396006|147259123|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||paired t-tests|||||||<0.0001
73856952|NCT00396006|147259124|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||paired t-tests|||||||<0.0001
73856953|NCT00396006|147259126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1875|||||||Wilcoxon signed rank test|||||||0.1875
73856954|NCT00396006|147259127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4375|||||||Wilcoxon signed rank|||||||0.4375
74025987|NCT03704051|147605020|EQUIVALENCE|A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.||||||0.115|||||||Mixed Models Analysis|All models adjusted for order of conditions, time since last feeding and infant age.||||||0.115
73908269|NCT01967342|147346340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.251|STANDARD_ERROR_OF_MEAN|0.617|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
73856955|NCT00075946|147259138|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3||||0.33|TWO_SIDED|95.0|0.9|1.88|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.|The primary analysis is to compare the time to rituximab failure (TTRF) between the retreatment arm and the scheduled arm in follicular patients.||1.88|0.90|0.33
73856956|NCT00075946|147259138|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.75||||0.012|TWO_SIDED|95.0|1.22|6.19|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in non-follicular patients.|||6.19|1.22|0.012
73856957|NCT00075946|147259139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.21||||0.002|TWO_SIDED|95.0|1.45|7.13|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.|||7.13|1.45|0.002
73856958|NCT00075946|147259139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||Log Rank|||||||0.0002
73856959|NCT00075946|147259140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.270
73856960|NCT05898672|147259146|OTHER||Ratio of adjusted geometric means|131.18|||||TWO_SIDED|90.0|115.89|148.48||||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant within sequence as a random effect. Ratio of adjusted geometric means of test to reference was reported; where test treatment is Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg and reference treatment is Rosuvastatin 10 mg. Ratio and associated 90% CIs were reported in percentage.||148.48|115.89|
73856961|NCT05898672|147259147|OTHER||Ratio of adjusted geometric means|212.44|||||TWO_SIDED|90.0|174.31|258.9||||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant within sequence as a random effect. Ratio of adjusted geometric means of test to reference was reported; where test treatment is Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg and reference treatment is Rosuvastatin 10 mg. Ratio and associated 90% CIs were reported in percentage.||258.90|174.31|
73856962|NCT01229254|147259156|EQUIVALENCE|If the 90% confidence interval was within the pre-specified bounds of \[0.66, 1.50\], the hypothesis of similarity between lower weight and higher weight groups was supported.|Ratio of geometric least-squares means|0.748|||||TWO_SIDED|90.0|0.591|0.948||||||Compared to Betrixaban 90 mg (≥80 kg)||0.948|0.591|
73856963|NCT00744978|147259180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.3873|TWO_SIDED|95.0|-1.37|0.53||ANCOVA model using unstructured covariance structure; Type I error rate for primary hypothesis was 5%; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.53|-1.37|0.3873
73856964|NCT00744978|147259181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.2465|TWO_SIDED|95.0|-0.39|1.49||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.49|-0.39|0.2465
73908270|NCT01967342|147346340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.434|STANDARD_ERROR_OF_MEAN|0.541||0.422|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the post-treatment and 6-month follow-up.||||.422
73856965|NCT00744978|147259182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.2092|TWO_SIDED|95.0|-0.33|1.5||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.50|-0.33|0.2092
73856966|NCT00744978|147259183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.4339|TWO_SIDED|95.0|-1.3|0.56||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.56|-1.30|0.4339
73856967|NCT00744978|147259184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9745|TWO_SIDED|95.0|-0.26|0.27|||ANCOVA|||Difference from placebo analyzed using a mixed effects linear model with subject (nested within sequence) as a random effect, and stratum, site, period, sequence, and treatment as fixed effects.||0.27|-0.26|0.9745
73908271|NCT01967342|147346341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.45|||<|0.001|TWO_SIDED||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (6-months).||||<.001
73908272|NCT01967342|147346341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53||||0.001|TWO_SIDED||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (10-weeks).||||.001
74025988|NCT03715465|147605021|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.510
74025989|NCT03715465|147605022|SUPERIORITY|||||||0.411|||||||t-test, 2 sided|||Per diary||||0.411
74025990|NCT03715465|147605022|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Per wrist actigraphy||||0.920
74025991|NCT03715465|147605023|SUPERIORITY|||||||0.787|||||||t-test, 2 sided|||Per diary||||0.787
73908273|NCT01967342|147346341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.217|TWO_SIDED||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at pre-treatment (10-weeks).||||.217
73908274|NCT01967342|147346341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.009|TWO_SIDED||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.009
73908275|NCT01967342|147346341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.32||||0.001|TWO_SIDED||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.001
73908276|NCT01967342|147346341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.389|TWO_SIDED||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.389
73908277|NCT03789214|147346357|OTHER|One-way ANOVA||||||0.95|||||||ANOVA|||||||.950
73908278|NCT03789214|147346358|OTHER|One-way ANOVA||||||0.048|||||||ANOVA|||||||.048
73908279|NCT03789214|147346359|OTHER|One-way ANOVA||||||0.691|||||||ANOVA|||||||.691
73908280|NCT03789214|147346360|OTHER|One-way ANOVA||||||0.62|||||||ANOVA|||||||.620
73908281|NCT03789214|147346361|OTHER|One-way ANOVA||||||0.067|||||||ANOVA|||||||.067
74025992|NCT03715465|147605023|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|||Per wrist actigraphy||||0.916
73908282|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|-10.59|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
73908283|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|2.18|STANDARD_ERROR_OF_MEAN|2.42||0.1858|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.1858
73908284|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|8.66|STANDARD_ERROR_OF_MEAN|2.55||0.0007|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.0007
73908285|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|14.45|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
73908286|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|-14.14|STANDARD_ERROR_OF_MEAN|4.55|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
73908287|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|1.91|STANDARD_ERROR_OF_MEAN|4.56||0.3384|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.3384
73908288|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|19.38|STANDARD_ERROR_OF_MEAN|3.94|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
73908289|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|38.37|STANDARD_ERROR_OF_MEAN|9.76||0.0002|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.0002
73908290|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|-23.96|STANDARD_ERROR_OF_MEAN|4.88|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
73908291|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|2.47|STANDARD_ERROR_OF_MEAN|5.4||0.3249|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.3249
73908292|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|29.23|STANDARD_ERROR_OF_MEAN|6.53|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
73908293|NCT02633501|147346458|SUPERIORITY||Least Squares Mean|51.96|STANDARD_ERROR_OF_MEAN|10.68|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
73908294|NCT02927262|147346572|SUPERIORITY||Hazard Ratio (HR)|0.738||||0.163|TWO_SIDED|95.0|0.407|1.336|||Log Rank||HR \& 95% CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors:age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||1.336|0.407|0.163
73908295|NCT02927262|147346573|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.627||95.0|0.54|2.364|||Log Rank||HR \& 95%CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors: age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||2.364|0.540|0.627
73908296|NCT02927262|147346574|SUPERIORITY||Hazard Ratio (HR)|0.862||||0.296|TWO_SIDED|95.0|0.51|1.455|||Log Rank||HR \& 95%CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors: age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||1.455|0.510|0.296
73908297|NCT02927262|147346575|SUPERIORITY|||||||0.97||||||2-sided P-value from analysis of covariance (ANCOVA) including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 3||||0.970
73908298|NCT02927262|147346575|SUPERIORITY|||||||0.415||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 6||||0.415
73908299|NCT02927262|147346575|SUPERIORITY|||||||0.271||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 12||||0.271
73908300|NCT02927262|147346575|SUPERIORITY|||||||0.179||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 24/EoT||||0.179
73908301|NCT01697358|147346583|SUPERIORITY|||||||0.036|||||||Z-test using unpooled standard deviation|||||||0.036
73908302|NCT01697358|147346584|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.||||||< 0.001
74025993|NCT03715465|147605024|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Per diary||||0.270
74025994|NCT03715465|147605024|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||Per wrist actigraphy||||0.406
74025995|NCT03715465|147605025|SUPERIORITY|||||||0.635|||||||t-test, 2 sided|||Per diary||||0.635
73964518|NCT04992390|147464628|SUPERIORITY|Poisson regression was performed with baseline measure and binary arm status included as fixed effect covariates. Various regression models for count data were compared to find the best fitting model. Visual exploratory data and model evaluation showed that the Zero Inflated Negative Binomial (ZINB) regression model provided the best fit and was used as the model for the ITT analysis of the primary outcome.|Incidence Rate Ratio|0.31|||<=|0.001|TWO_SIDED|95.0|0.2|0.48||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|||For more information on analysis models see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|See also Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|0.48|0.20|<= 0.001
73964519|NCT04992390|147464629|SUPERIORITY|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the delayed intervention arm, comparing pre-intervention (week 4) to post-intervention (week 8).|Incidence Rate Ratio|0.31|||<=|0.001|TWO_SIDED|95.0|0.21|0.45||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories pre- to post-intervention.||Within the comparator arm, where participants had delayed access to the intervention (i.e., delayed arm crossover), the number of intrusive memories in week 8 was compared to week 4. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|For full results see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|0.45|0.21|<= 0.001
73856968|NCT00744978|147259185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.2852|TWO_SIDED|95.0|-0.57|1.92||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.92|-0.57|0.2852
73971129|NCT03257410|147482767|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the mean estimated treatment difference between Theranova 400 and Elisio 17H is \> -0.1765 g/dL then non-inferiority can be claimed. If the lower bound of the two-sided 95% confidence interval is \> 0, then superiority may be concluded.|Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.098|0.069|||ANCOVA|||||0.069|-0.098|
73971130|NCT03257410|147482768|OTHER||Mean Difference (Final Values)|19.42|STANDARD_ERROR_OF_MEAN|2.103|<|0.0001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||<0.0001
73971131|NCT03257410|147482768|OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|2.115|<|0.0001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||<0.0001
73856969|NCT00744978|147259186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.0468|TWO_SIDED|95.0|0.02|2.53||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||2.53|0.02|0.0468
73856970|NCT00744978|147259187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8811|TWO_SIDED|95.0|-0.02|0.03||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.03|-0.02|0.8811
73856971|NCT00744978|147259188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.083|TWO_SIDED|95.0|0.0|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.00|0.0830
73856972|NCT00744978|147259189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.7226|TWO_SIDED|95.0|-0.03|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.03|0.7226
73971132|NCT03257410|147482769|OTHER||Mean Difference (Final Values)|25.07|STANDARD_ERROR_OF_MEAN|4.3|<|0.0001|TWO_SIDED||||||MMRM|||Week 4||||<0.0001
73971133|NCT03257410|147482769|OTHER||Mean Difference (Final Values)|23.54|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||MMRM|||Week 24||||<0.0001
73971134|NCT03257410|147482770|OTHER||Mean Difference (Final Values)|15.89|STANDARD_ERROR_OF_MEAN|2.73|<|0.0001|TWO_SIDED||||||MMRM|||Week 4||||<0.0001
73971135|NCT03257410|147482770|OTHER||Mean Difference (Final Values)|15.36|STANDARD_ERROR_OF_MEAN|2.479|<|0.0001|TWO_SIDED||||||MMRM|||Week 24||||<0.0001
73971136|NCT03257410|147482771|OTHER||Mean Difference (Final Values)|17.59|STANDARD_ERROR_OF_MEAN|9.583||0.0684|TWO_SIDED||||||MMRM|||Week 4||||0.0684
73971137|NCT03257410|147482771|OTHER||Mean Difference (Final Values)|13.98|STANDARD_ERROR_OF_MEAN|7.937||0.0806|TWO_SIDED||||||MMRM|||Week 24||||0.0806
73971138|NCT03257410|147482776|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.0347|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.0347
73971139|NCT03257410|147482776|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.033||0.0036|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 8||||0.0036
73971140|NCT03257410|147482776|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.129|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.129
73971141|NCT03257410|147482776|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.052||0.1149|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 16||||0.1149
73971142|NCT03257410|147482776|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.044||0.0688|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 20||||0.0688
73971143|NCT03257410|147482776|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.042||0.6097|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.6097
73908303|NCT01697358|147346585|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.||||||< 0.001
74025996|NCT03715465|147605025|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||Per wrist actigraphy||||0.383
73856973|NCT00744978|147259190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.5588|TWO_SIDED|95.0|-6.68|3.62||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Week 1: difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||3.62|-6.68|0.5588
73856974|NCT00744978|147259191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.15||||0.1173|TWO_SIDED|95.0|-9.34|1.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.05|-9.34|0.1173
73856975|NCT00744978|147259192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.6251|TWO_SIDED|95.0|-6.58|3.96||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||3.96|-6.58|0.6251
73856976|NCT00744978|147259193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9109|TWO_SIDED|95.0|-0.05|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.05|0.9109
73856977|NCT00744978|147259194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.6632|TWO_SIDED|95.0|-0.06|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.06|0.6632
73908304|NCT01697358|147346586|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline ODI, treatment group, and virtual center.||||||< 0.001
73856978|NCT00744978|147259195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.545|TWO_SIDED|95.0|-0.07|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.07|0.5450
73856979|NCT00744978|147259196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.2799|TWO_SIDED|95.0|-0.02|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.02|0.2799
73908305|NCT01697358|147346587|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline PCS, treatment group, and virtual center.||||||< 0.001
73908306|NCT01697358|147346588|SUPERIORITY||||||<|0.001|||||||Z-test using unpooled standard deviation|||||||< 0.001
73971144|NCT03257410|147482777|OTHER||Mean Difference (Final Values)|-6.32|STANDARD_ERROR_OF_MEAN|4.336||0.1472|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.1472
73971145|NCT03257410|147482777|OTHER||Mean Difference (Final Values)|-11.18|STANDARD_ERROR_OF_MEAN|7.154||0.1207|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.1207
73971146|NCT03257410|147482778|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.488||0.9775|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.9775
73971147|NCT03257410|147482778|OTHER||Mean Difference (Final Values)|1.72|STANDARD_ERROR_OF_MEAN|2.905||0.5538|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.5538
73971148|NCT03257410|147482779|OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.146||0.11|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.1100
73971149|NCT03257410|147482779|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4607|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.4607
73971150|NCT03257410|147482780|OTHER||Mean Difference (Final Values)|-0.0787|STANDARD_ERROR_OF_MEAN|0.04454||0.0791|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.0791
73971151|NCT03257410|147482780|OTHER||Mean Difference (Final Values)|-0.0027|STANDARD_ERROR_OF_MEAN|0.04302||0.9505|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 8||||0.9505
73971152|NCT03257410|147482780|OTHER||Mean Difference (Final Values)|-0.0615|STANDARD_ERROR_OF_MEAN|0.04271||0.1521|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.1521
73971153|NCT03257410|147482780|OTHER||Mean Difference (Final Values)|0.0538|STANDARD_ERROR_OF_MEAN|0.04652||0.2489|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 16||||0.2489
73971154|NCT03257410|147482780|OTHER||Mean Difference (Final Values)|-0.0345|STANDARD_ERROR_OF_MEAN|0.05025||0.4936|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 20||||0.4936
73971155|NCT03257410|147482780|OTHER||Mean Difference (Final Values)|-0.0663|STANDARD_ERROR_OF_MEAN|0.0458||0.1497|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.1497
73971156|NCT03257410|147482781|OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|2.012||0.9001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.9001
73971157|NCT03257410|147482781|OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|2.372||0.3279|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.3279
73971158|NCT03257410|147482782|OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.452||0.6576|TWO_SIDED||||||ANCOVA|||||||0.6576
73971159|NCT03257410|147482783|OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.104||0.0058|TWO_SIDED||||||ANCOVA|||||||0.0058
74025997|NCT03715465|147605026|SUPERIORITY|||||||0.456|||||||t-test, 2 sided|||||||0.456
74025998|NCT03715465|147605027|SUPERIORITY|||||||0.402|||||||t-test, 2 sided|||||||0.402
74025999|NCT03715465|147605028|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
74026000|NCT03715465|147605029|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||||||0.525
74026001|NCT03715465|147605030|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||||||0.106
74026002|NCT03715465|147605031|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||||||0.059
74026003|NCT03715465|147605032|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
74026004|NCT03715465|147605033|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||||||0.246
74026005|NCT03715465|147605034|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||||||0.333
74026006|NCT03815292|147605035|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
74026007|NCT03815292|147605036|SUPERIORITY|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.0445
73856980|NCT00744978|147259197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9675|TWO_SIDED|95.0|-0.03|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo aAnalyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.03|0.9675
74026008|NCT03815292|147605037|SUPERIORITY|||||||0.0345|||||||Fisher Exact|||||||0.0345
73856981|NCT00744978|147259198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5008|TWO_SIDED|95.0|-0.05|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.05|0.5008
73908307|NCT00471146|147346589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014||||0.5436|TWO_SIDED|95.0|0.786|1.309||One-sided log-rank test at alpha = 0.025 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||1.309|0.786|0.5436
73908308|NCT00471146|147346590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.006||||0.5203|TWO_SIDED|95.0|0.779|1.298||One-sided log-rank test at alpha = 0.025 significance level was used.The p-value was not adjusted for multiple testing.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||1.298|0.779|0.5203
73908309|NCT00471146|147346591|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.2||||0.038|TWO_SIDED|95.0|1.0|10.1|||Cochran-Mantel-Haenszel|||Differences in OR between treatment arms was analyzed by 1-sided Cochran-Mantel-Haenszel (CMH) test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||10.1|1.0|0.038
73908310|NCT02963935|147346607|SUPERIORITY|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised subjects regardless of premature discontinuation of trial product.|Treatment difference|-3.45||||0.0003|TWO_SIDED|95.0|-5.31|-1.59|||ANCOVA|Missing observations were imputed from the placebo arm based on a jump to reference (x100) multiple imputation approach.|Liraglutide 3.0 mg - placebo|Treatrment policy estimand. The hypothesis and the alternative are: H: μliraglutide ≥ μplacebo against the alternative HA: μliraglutide \< μplacebo. μliraglutide and μplacebo denote the true mean of % weight change for liraglutide 3.0 mg and placebo group, respectively. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.||-1.59|-5.31|0.0003
73908311|NCT02963935|147346607|OTHER|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised subjects assuming that all subjects remained on trial product (on-treatment principle)|Treatment difference|-4.59||||0|TWO_SIDED|95.0|-6.54|-2.64|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug data before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit.||-2.64|-6.54|0.0000
73908312|NCT02963935|147346608|SUPERIORITY||Odds Ratio (OR)|2.51||||0.0003|TWO_SIDED|95.0|1.53|4.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.||4.14|1.53|0.0003
73908313|NCT02963935|147346608|OTHER||Odds Ratio (OR)|2.84||||0|TWO_SIDED|95.0|1.75|4.61|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||4.61|1.75|0.0000
73908314|NCT02963935|147346609|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0469|TWO_SIDED|95.0|1.01|3.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x10000) imputation approach.||3.14|1.01|0.0469
73908315|NCT02963935|147346609|OTHER||Odds Ratio (OR)|2.14||||0.0063|TWO_SIDED|95.0|1.24|3.69|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||3.69|1.24|0.0063
73908316|NCT02963935|147346610|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0311|TWO_SIDED|95.0|1.08|4.74|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.||4.74|1.08|0.0311
74026009|NCT03815292|147605038|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.04
73856982|NCT00744978|147259199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.2245|TWO_SIDED|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.01|-0.03|0.2245
73856983|NCT00744978|147259200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.4974|TWO_SIDED|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.01|-0.03|0.4974
73856984|NCT00744978|147259201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8525|TWO_SIDED|95.0|-0.02|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.02|0.8525
73856985|NCT01218958|147259202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0245|TWO_SIDED|95.0|0.6|0.94||The Hochberg method was used to adjust P-value for multiple comparisons (ie, 380 mg dose vs. placebo and 190 mg dose vs. placebo).|Andersen-Gill recurrent-event Cox|||"The event rate (percentage) is represented by the number of heavy drinking days divided by number of days at risk. For each day, the active groups' results were contrasted with placebo to form the event rate ratio. Thus, a hazard ratio of 0.75 for the 380 mg group indicates a 25% reduction in heavy drinking compared with that of placebo.~The method of analysis estimates the average ratio over time and accounts for discontinuation. Point/interval estimates for pairwise ratios were derived."||0.940|0.600|0.0245
73856986|NCT01218958|147259202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0744|TWO_SIDED|95.0|0.677|1.018|||Andersen-Gill recurrent-event Cox model|||||1.018|0.677|0.0744
73856987|NCT01179217|147259206|SUPERIORITY_OR_OTHER_LEGACY||Wilcoxon rank-sum test|0.5||||0.0052|TWO_SIDED|||||"1. The primary analysis was analyzed using a CMH analysis of the number of SCCs using modified ridit scores.~2. P-value (controlling for region and HU use)~3. The null hypothesis of the final analysis was performed at the 0.045 significance level."|Cochran-Mantel-Haenszel|||||||0.0052
73856988|NCT01179217|147259207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||||||0.0045
73856989|NCT01179217|147259208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0888|||||||Cochran-Mantel-Haenszel|||||||0.0888
73856990|NCT01849575|147259221|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
73856991|NCT03359785|147259241|SUPERIORITY||LS Mean Difference|0.278|STANDARD_ERROR_OF_MEAN|0.376||0.2401|ONE_SIDED|90.0|-0.246||||ANOVA||||||-0.246|0.2401
73856992|NCT03359785|147259241|SUPERIORITY||LS Mean Difference|-0.766|STANDARD_ERROR_OF_MEAN|0.547||0.9053|ONE_SIDED|90.0|-1.513||||ANOVA||||||-1.513|0.9053
73856993|NCT04077996|147259249|NON_INFERIORITY|The margin of non inferiority analysis was established at 30%.|Risk Ratio (RR)|1.11|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|95.0|0.91|1.3|||Chi-squared, Corrected|||Summary statistics were computed, and a significance level (α) of 5% has been established.||1.3|0.91|<0.05
74026010|NCT03815292|147605039|SUPERIORITY|||||||0.0016|||||||t-test, 2 sided|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.0016
73856994|NCT04077996|147259249|NON_INFERIORITY|margin 30%|Risk Ratio (RR)|1.0|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
73856995|NCT04077996|147259250|NON_INFERIORITY|The margin was established at 30%.|Risk Ratio (RR)|1.0|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|1.0|0.14|6.6|||Fisher Exact|||||6.6|0.14|<0.05
73856996|NCT04730635|147259283|OTHER||Posterior Probability|46.3||||||||||||||There was a threshold of ≥2 percentage points. A posterior probability value \>55% was required to satisfy the primary hypothesis.||||
73856997|NCT04730635|147259284|OTHER||Posterior Probability|80.67||||||||||||||There was a threshold of ≤ 0.1 for this standard deviation change. A posterior probability value \>70% was required to satisfy this secondary hypothesis.||||
73908317|NCT02963935|147346610|OTHER||Odds Ratio (OR)|2.74||||0.006|TWO_SIDED|95.0|1.33|5.62|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||5.62|1.33|0.0060
73908318|NCT02963935|147346611|SUPERIORITY||Odds Ratio (OR)|3.32|||<|0.0001|TWO_SIDED|95.0|1.93|5.72|||Regression, Logistic||Liraglutide 3.0 mg/placebo|"Treatment policy estimand. Week 16 responders were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.~Missing values are considered as non-responders."||5.72|1.93|<0.0001
74026011|NCT03815292|147605040|SUPERIORITY|||||||0.0054|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Therapeutic effect row.||||0.0054
73856998|NCT04730635|147259285|OTHER||Posterior Probability|98.8||||||||||||||||||
73856999|NCT01096368|147259286|SUPERIORITY||Hazard Ratio (HR)|0.866||||0.229|TWO_SIDED|90.46|0.627|1.197||P-value is one-sided. After adjusting for interim analyses, the a priori threshold for significance for the final analysis is one-sided alpha=0.031.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III. Confidence interval is stage-wise adjusted for multiple interim analyses.|The study was designed to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 1-sided log-rank test. The planned sample size was 160 subjects per arm. 85 EFS events were needed, which were expected after 8 years of accrual and 2 years of follow-up. At 5% type 1 error, the study had 93% power to detect an increase in 2-year EFS from 75% (RT alone) to 87% (RT+maintenance). The design also incorporated interim analyses for futility and efficacy.||1.197|0.627|0.229
74026012|NCT03815292|147605040|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Side effects row.||||0.78
74026013|NCT03815292|147605040|SUPERIORITY|||||||0.0042|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Efficiency index row.||||0.0042
74026014|NCT03815292|147605041|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.77
74026015|NCT03815292|147605042|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.0118
74026016|NCT03815292|147605043|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.058
73857000|NCT01096368|147259287|SUPERIORITY||Hazard Ratio (HR)|0.757||||0.172|TWO_SIDED|90.46|0.463|1.238||P-value is one-sided. After adjusting for interim analyses, the a priori threshold for significance for the final analysis is one-sided alpha=0.031.|Log Rank||Hazard ratio is based on hazard of death for Arm II over hazard of death for Arm III. Confidence interval is stage-wise adjusted for multiple interim analyses.|It was planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 1-sided log-rank test using the planned sample size of 160 subjects per arm which was optimized for the EFS outcome. A one-sided significance threshold of 5% was planned for this comparison as well.||1.238|0.463|0.172
73857001|NCT01096368|147259288|SUPERIORITY||Hazard Ratio (HR)|0.701||||0.096|TWO_SIDED|95.0|0.461|1.068||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.|In stratum 1, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||1.068|0.461|0.096
73857002|NCT01096368|147259289|SUPERIORITY||Hazard Ratio (HR)|2.684||||0.041|TWO_SIDED|95.0|1.004|7.175||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.|In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||7.175|1.004|0.041
73857003|NCT01096368|147259290|SUPERIORITY||Hazard Ratio (HR)|0.547||||0.067|TWO_SIDED|95.0|0.284|1.053||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of death for Arm II over death of events for Arm III.|In stratum 1, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||1.053|0.284|0.067
73857004|NCT01096368|147259291|SUPERIORITY||Hazard Ratio (HR)|3.601||||0.094|TWO_SIDED|95.0|0.724|17.902||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of death for Arm II over hazard of death for Arm III.|In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||17.902|0.724|0.094
73857005|NCT01974206|147259313|OTHER||Common Odds Ratio|0.79||||0.307|TWO_SIDED|90.0|0.43|1.47||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization strata, and the 90% CIs of the CMH odds ratio stratified by randomization group.||1.47|0.43|0.307
73857006|NCT01974206|147259314|OTHER||Common Odds Ratio|0.99||||0.576|TWO_SIDED|90.0|0.46|2.15||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||2.15|0.46|0.576
73857007|NCT01974206|147259315|OTHER||Common Odds Ratio|0.88||||0.408|TWO_SIDED|90.0|0.48|1.59||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||1.59|0.48|0.408
73857008|NCT01974206|147259316|OTHER||Common Odds Ratio|0.88||||0.419|TWO_SIDED|90.0|0.48|1.61||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||1.61|0.48|0.419
73857009|NCT01974206|147259317|OTHER|||||||0.5||||||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||Exact Cochran-Mantel-Haenszel estimate of the common odds ratio could not be calculated as 100% of ASP0113 group showed graft survival, and this leads to having a value of 0 for the denominator for the ratio thus odds ratio is not estimable. The 90% CI (2-sided) values for the odds ratio are 0.11 to NA, where NA is an infinity value.||||0.5
73857010|NCT02118766|147259323|SUPERIORITY_OR_OTHER|||||||0.038|||||||Regression, Logistic|||||||0.038
73857011|NCT01846299|147259455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78|STANDARD_ERROR_OF_MEAN|1.203||0.0111|TWO_SIDED|95.0|0.4|5.16|||Mixed Models Analysis|||||5.16|0.40|0.0111
73857012|NCT01357161|147259491|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.08|TWO_SIDED|80.0|0.45|0.89|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||0.89|0.45|0.080
74026017|NCT01142323|147605086|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0|||||Matched pairs|||||||0.008
74026018|NCT01142323|147605087|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
74026019|NCT00430781|147605091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.535||90.0|0.65|1.7||Stratified log-rank test with one-sided p-value. p\<=0.0037 required for significance, and p\>0.4956 indicated futility.|Log Rank||The estimated value is the hazard ratio comparing combination to lapatinib monotherapy|||1.7|0.65|0.535
74026020|NCT00430781|147605094|SUPERIORITY_OR_OTHER|||||||0.237||95.0||||One-sided p-value.|Fisher Exact|||||||0.237
74085202|NCT02156154|147724012|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.56|TWO_SIDED|99.4|-0.49|0.76||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as differences in means between the study groups, assessed using a 2-sample t test.|||0.76|-0.49|0.56
73857013|NCT01357161|147259493|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55||||0.03|TWO_SIDED|80.0|0.39|0.79|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||0.79|0.39|0.030
73908319|NCT02963935|147346612|SUPERIORITY||treatment difference|-2.72||||0.0063|TWO_SIDED|95.0|-4.68|-0.77|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||-0.77|-4.68|0.0063
73857014|NCT01357161|147259495|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|3.3|||||TWO_SIDED|95.0|-2.9|11.4||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.||11.4|-2.9|
73857015|NCT01357161|147259496|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|-1.3|||||TWO_SIDED|95.0|-16.2|13.6||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.||13.6|-16.2|
73857016|NCT01357161|147259497|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rat|5.2||||0.5247|TWO_SIDED|95.0|-10.9|21.1|||Miettinen and Nurminen's Method|||Stratified Miettinen and Nurminen's method with a two-sided p-Value for testing was used for comparison of the ORRs between the treatment groups in Part 2 portion of the study. A 95% confidence interval (CI) for the difference in response rates was provided.||21.1|-10.9|0.5247
73857017|NCT01357161|147259498|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.15||||0.8|TWO_SIDED|95.0|0.4|3.34|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||3.34|0.40|0.800
73857018|NCT02791191|147259510|SUPERIORITY|||||||0.418|||||||ANCOVA|||||||0.418
73857019|NCT02791191|147259510|SUPERIORITY|||||||0.231|||||||ANCOVA|||||||0.231
73857020|NCT02791191|147259511|SUPERIORITY|||||||1|||||||Fisher Exact|||White Matter Disease||||1.000
73857021|NCT02791191|147259511|SUPERIORITY|||||||1|||||||Fisher Exact|||White Matter Disease||||1.000
73857022|NCT02791191|147259511|SUPERIORITY|||||||0.404|||||||Fisher Exact|||||||0.404
73857023|NCT02791191|147259511|SUPERIORITY|||||||1|||||||Fisher Exact|||Cortical Superficial Siderous||||1.000
73971160|NCT03257410|147482784|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.023||0.034|TWO_SIDED||||||ANCOVA|||||||0.034
73971161|NCT03257410|147482785|OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.071||0.0285|TWO_SIDED||||||ANCOVA|||||||0.0285
73857024|NCT02791191|147259511|SUPERIORITY|Lacunar Infarct||||||1|||||||Fisher Exact|||||||1.000
73857025|NCT02791191|147259511|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Lacunar Infarct||||0.457
73857026|NCT02791191|147259511|SUPERIORITY|||||||1|||||||Fisher Exact|||Other Infarct||||1.000
73857027|NCT02791191|147259511|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Other Infarct||||0.457
73857028|NCT02791191|147259512|SUPERIORITY|||||||1|||||||Fisher Exact|||Vasogenic Edema||||1.000
73857029|NCT02791191|147259512|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Vasogenic Edema||||0.457
73857030|NCT02791191|147259512|SUPERIORITY|||||||0.703|||||||Fisher Exact|||Increase in Microhemorrhage||||0.703
73857031|NCT02791191|147259512|SUPERIORITY|||||||1|||||||Fisher Exact|||Increase in Microhemorrhage||||1.000
73857032|NCT02791191|147259513|SUPERIORITY|||||||0.452|||||||Fisher Exact|||Treatment Emergent Suicidal Ideation||||0.452
73857033|NCT02791191|147259513|SUPERIORITY|||||||0.279||||||TE Suicidal Ideation|Fisher Exact|||||||0.279
73857034|NCT02791191|147259513|SUPERIORITY|||||||0.293|||||||Fisher Exact|||Emergence of Suicidal Behavior||||0.293
73857035|NCT02791191|147259513|SUPERIORITY|||||||0.486|||||||Fisher Exact|||Emergence of Suicidal Behavior||||0.486
73857036|NCT02791191|147259515|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta||||<.001
73857037|NCT02791191|147259515|SUPERIORITY|Amyloid Beta|||||<|0.001|||||||ANCOVA|||||||<.001
73971162|NCT03257410|147482786|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.513||0.9069|TWO_SIDED||||||ANCOVA|||||||0.9069
73971163|NCT03257410|147482787|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.443||0.8413|TWO_SIDED||||||ANCOVA|||||||0.8413
73971164|NCT03257410|147482788|OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.382||0.0125|TWO_SIDED||||||ANCOVA|||||||0.0125
73971165|NCT03257410|147482789|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.561||0.6891|TWO_SIDED||||||ANCOVA|||||||0.6891
73971166|NCT03257410|147482790|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.047||0.6043|TWO_SIDED||||||ANCOVA|||||||0.6043
73971167|NCT03257410|147482791|OTHER||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|2.08||0.5067|TWO_SIDED||||||ANCOVA|||||||0.5067
73971168|NCT03257410|147482792|OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.0297|TWO_SIDED||||||ANCOVA|||||||0.0297
73971169|NCT03257410|147482793|OTHER||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|2.14||0.1325|TWO_SIDED||||||ANCOVA|||||||0.1325
73971170|NCT03257410|147482794|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.186||0.2304|TWO_SIDED||||||ANCOVA|||||||0.2304
73971171|NCT03257410|147482795|OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|2.846||0.5785|TWO_SIDED||||||ANCOVA|||||||0.5785
73971172|NCT03257410|147482796|OTHER||Mean Difference (Final Values)|2.55|STANDARD_ERROR_OF_MEAN|0.918||0.0067|TWO_SIDED||||||ANCOVA|||||||0.0067
73971173|NCT03257410|147482797|OTHER||Mean Difference (Final Values)|-14.93|STANDARD_ERROR_OF_MEAN|7.314||0.0434|TWO_SIDED||||||ANCOVA|||||||0.0434
73971174|NCT03257410|147482798|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.3281|TWO_SIDED||||||ANCOVA|||||||0.3281
73971175|NCT03257410|147482799|OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.334||0.0463|TWO_SIDED||||||ANCOVA|||||||0.0463
73971176|NCT03257410|147482800|OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.1925|TWO_SIDED||||||ANCOVA|||||||0.1925
73971177|NCT03257410|147482801|OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.389||0.2569|TWO_SIDED||||||ANCOVA|||||||0.2569
73857038|NCT02791191|147259515|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-40||||<.001
73857039|NCT02791191|147259515|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-40||||<.001
73857040|NCT02791191|147259515|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-42||||<.001
73857041|NCT02791191|147259515|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-42||||<.001
73857042|NCT02791191|147259516|SUPERIORITY|||||||0.97|||||||Mixed Model Repeated Measures|||||||0.970
73857043|NCT02791191|147259516|SUPERIORITY|||||||0.586|||||||Mixed Model Repeated Meausres|||||||0.586
73857044|NCT02791191|147259517|SUPERIORITY|||||||0.088|||||||ANCOVA|||||||0.088
73857045|NCT02791191|147259517|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.150
73857046|NCT02791191|147259518|SUPERIORITY|||||||0.153|||||||ANCOVA|||||||0.153
73857047|NCT02791191|147259518|SUPERIORITY|||||||0.176|||||||ANCOVA|||||||0.176
73971178|NCT03257410|147482802|OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|1.104||0.5709|TWO_SIDED||||||ANCOVA|||||||0.5709
73971179|NCT03257410|147482803|OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.412||0.217|TWO_SIDED||||||ANCOVA|||||||0.217
73971180|NCT03257410|147482804|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|1.292||0.2386|TWO_SIDED||||||ANCOVA|||||||0.2386
73971181|NCT03257410|147482805|OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.84||0.1769|TWO_SIDED||||||ANCOVA|||||||0.1769
73971182|NCT03257410|147482806|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.36||0.8102|TWO_SIDED||||||ANCOVA|||||||0.8102
73971183|NCT03257410|147482807|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|1.501||0.9672|TWO_SIDED||||||ANCOVA|||||||0.9672
73971184|NCT03257410|147482808|OTHER||Mean Difference (Final Values)|27.34|STANDARD_ERROR_OF_MEAN|24.623||0.2697|TWO_SIDED||||||ANCOVA|||||||0.2697
73971185|NCT03257410|147482811|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.115||0.7189|TWO_SIDED||||||ANCOVA|||||||0.7189
73971186|NCT03257410|147482812|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.044||0.097|TWO_SIDED||||||ANCOVA|||||||0.097
73971187|NCT03257410|147482813|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.113||0.4513|TWO_SIDED||||||ANCOVA|||||||0.4513
73971188|NCT03257410|147482814|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0733|TWO_SIDED||||||ANCOVA|||||||0.0733
73971189|NCT03257410|147482815|OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|5.467||0.5326|TWO_SIDED||||||ANCOVA|||||||0.5326
73971190|NCT03257410|147482816|OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|1.076||0.3042|TWO_SIDED||||||ANCOVA|||||||0.3042
73971191|NCT03257410|147482817|OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.976||0.5534|TWO_SIDED||||||ANCOVA|||||||0.5534
73971192|NCT03257410|147482818|OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|1.181||0.2958|TWO_SIDED||||||ANCOVA|||||||0.2958
73971193|NCT03257410|147482819|OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.377||0.0998|TWO_SIDED||||||ANCOVA|||||||0.0998
73971194|NCT03257410|147482820|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|3.176||0.9952|TWO_SIDED||||||ANCOVA|||||||0.9952
73971195|NCT03257410|147482821|OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.693||0.3063|TWO_SIDED||||||ANCOVA|||||||0.3063
73971196|NCT03257410|147482822|OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.529||0.1098|TWO_SIDED||||||ANCOVA|||||||0.1098
73971197|NCT03257410|147482823|OTHER||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.797||0.0766|TWO_SIDED||||||ANCOVA|||||||0.0766
73971198|NCT03257410|147482824|OTHER||Mean Difference (Final Values)|-2.58|STANDARD_ERROR_OF_MEAN|2.41||0.2886|TWO_SIDED||||||ANCOVA|||||||0.2886
73971199|NCT03257410|147482825|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.042||0.4513|TWO_SIDED||||||ANCOVA|||||||0.4513
73971200|NCT03257410|147482826|OTHER||Mean Difference (Final Values)|1.56|STANDARD_ERROR_OF_MEAN|2.96||0.5992|TWO_SIDED||||||ANCOVA|||||||0.5992
73971201|NCT03257410|147482827|OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.29||0.3836|TWO_SIDED||||||ANCOVA|||||||0.3836
73971202|NCT03257410|147482828|OTHER||Mean Difference (Final Values)|-13.07|STANDARD_ERROR_OF_MEAN|7.284||0.0769|TWO_SIDED||||||ANCOVA|||||||0.0769
73971203|NCT03257410|147482829|OTHER||Mean Difference (Final Values)|-19.56|STANDARD_ERROR_OF_MEAN|5.17||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
73971204|NCT03257410|147482830|OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|1.039||0.1825|TWO_SIDED||||||ANCOVA|||||||0.1825
73971205|NCT03257410|147482831|OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.737||0.0957|TWO_SIDED||||||ANCOVA|||||||0.0957
73971206|NCT03257410|147482832|OTHER||Mean Difference (Final Values)|-34.02|STANDARD_ERROR_OF_MEAN|10.23||0.0012|TWO_SIDED||||||ANCOVA|||||||0.0012
73971207|NCT03257410|147482833|OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.859||0.1824|TWO_SIDED||||||ANCOVA|||||||0.1824
73971208|NCT03435614|147482845|OTHER||||||||||||||||||We selected the individual signs and symptoms associated with the presence of OIWS based on a difference of greater than 15 % in the assessments between the group with OIWS and the group not displaying OIWS. This 15 % difference was judged to be of clinical significance. The signs and symptoms which did not meet this difference were not considered (data not available).|||
73971209|NCT03526887|147482867|SUPERIORITY||Median Difference (Net)|9.7||||0.016|TWO_SIDED|95.0|9.4|19.1|||Log Rank|||||19.1|9.4|0.016
73971210|NCT06044090|147482980|SUPERIORITY|||||||0.856|||||||t-test, 2 sided|||||||0.856
73971211|NCT06044090|147482980|SUPERIORITY|||||||0.613|||||||t-test, 2 sided|||||||0.613
74026021|NCT00430781|147605098|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.66||||0.013||90.0|0.48|0.91||Stratified log-rank test with one-sided p-value.|Log Rank|||||0.91|0.48|0.013
73857048|NCT01448824|147259520|NON_INFERIORITY_OR_EQUIVALENCE|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of \~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS Means|1.94|||||TWO_SIDED|90.0|1.39|2.72||||||||2.72|1.39|
73857049|NCT01448824|147259521|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon signed rank|||||0.50|-0.50|1.0000
73857050|NCT01448824|147259522|NON_INFERIORITY_OR_EQUIVALENCE|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of \~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS means|2.37|||||TWO_SIDED|90.0|1.77|3.18||||||||3.18|1.77|
73857051|NCT05425732|147259532|OTHER|Miettinen \& Nurminen method|Difference in Percent|-0.9|||||TWO_SIDED|96.0|-2.8|1.1|||||V116 minus PCV20|Injection site erythema: estimated difference in percent||1.1|-2.8|
73857052|NCT05425732|147259532|OTHER|Miettinen \& Nurminen method|Difference in Percent|-12.2|||||TWO_SIDED|95.0|-16.2|-8.2|||||V116 minus PCV20|Injection site pain: estimated difference in percent||-8.2|-16.2|
73857053|NCT05425732|147259532|OTHER|Miettinen \& Nurminen method|Difference in Percent|-2.3|||||TWO_SIDED|95.0|-4.4|-0.2|||||V116 minus PCV20|Injection site swelling: estimated difference in percent||-0.2|-4.4|
73857054|NCT05425732|147259532|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-6.6|10.3|||||V116 minus PCV20|Injection site erythema: estimated difference in percent||10.3|-6.6|
73857055|NCT05425732|147259532|OTHER|Miettinen \& Nurminen method|Difference in Percent|-2.5|||||TWO_SIDED|95.0|-12.7|8.6|||||V116 minus PCV20|Injection site pain: estimated difference in percent||8.6|-12.7|
73857056|NCT05425732|147259532|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.0|||||TWO_SIDED|95.0|-9.2|7.9|||||V116 minus PCV20|Injection site swelling: estimated difference in percent||7.9|-9.2|
73857057|NCT05425732|147259533|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.6|||||TWO_SIDED|95.0|-2.7|3.8|||||V116 minus PCV20|Fatigue: estimated difference in percent||3.8|-2.7|
73857058|NCT05425732|147259533|OTHER|Miettinen \& Nurminen method|Difference in Percent|-1.5|||||TWO_SIDED|95.0|-4.1|1.2|||||V116 minus PCV20|Headache: estimated difference in percent||1.2|-4.1|
73857059|NCT05425732|147259533|OTHER|Miettinen \& Nurminen method|Difference in Percent|-0.8|||||TWO_SIDED|96.0|-2.8|1.2|||||V116 minus PCV20|Myalgia: estimated difference in percent||1.2|-2.8|
73857060|NCT05425732|147259533|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||||V116 minus PCV20|Pyrexia: estimated difference in percent||1.0|-1.0|
73857061|NCT05425732|147259533|OTHER|Miettinen \& Nurminen method|Difference in Percent|6.5|||||TWO_SIDED|95.0|-5.3|17.6|||||V116 minus PCV20|Fatigue: estimated difference in percent||17.6|-5.3|
73857062|NCT05425732|147259533|OTHER|Miettinen \& Nurminen method|Difference in Percent|5.5|||||TWO_SIDED|5.0|-5.5|15.5|||||V116 minus PCV20|Headache: estimated difference in percent||15.5|-5.5|
73857063|NCT05425732|147259533|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-6.8|10.6|||||V116 minus PCV20|Myalgia: estimated difference in percent||10.6|-6.8|
74026022|NCT02158533|147605099|SUPERIORITY||Least squares mean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.14||0.109|TWO_SIDED|95.0|-4.1|0.4||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5mg/0.5mg compared to placebo.||0.4|-4.1|0.109
73857064|NCT05425732|147259533|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-2.2|6.2|||||V116 minus PCV20|Pyrexia: estimated difference in percent||6.2|-2.2|
73857065|NCT05425732|147259535|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.4|1.72||1-sided|cLDA model||V116/PCV20|Serotype 3: V116/PCV20 GMT Ratio||1.72|1.40|<0.001
73857066|NCT05425732|147259535|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.68|0.88|||cLDA model||V116/PCV20|Serotype 6A: V116/PCV20 GMT Ratio||0.88|0.68|<0.001
73857067|NCT05425732|147259535|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.95|1.18|||cLDA model||V116/PCV20|Serotype 7F: V116/PCV20 GMT Ratio||1.18|0.95|<0.001
73857068|NCT05425732|147259535|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.38|||<|0.001|TWO_SIDED|95.0|1.25|1.53|||cLDA model||V116/PCV20|Serotype 8: V116/PCV20 GMT Ratio||1.53|1.25|<0.001
73857069|NCT05425732|147259535|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93|||cLDA model||V116/PCV20|Serotype 10A: V116/PCV20 GMT Ratio||0.93|0.75|<0.001
73857070|NCT05425732|147259535|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.39|1.72|||cLDA model||V116/PCV20|Serotype 11A: V116/PCV20 GMT Ratio||1.72|1.39|<0.001
73908320|NCT02963935|147346612|OTHER||Treatment difference|-3.45||||0.002|TWO_SIDED|95.0|-5.62|-1.28|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||-1.28|-5.62|0.0020
73908321|NCT02963935|147346613|SUPERIORITY||Treatment difference|0.16||||0.8137|TWO_SIDED|95.0|-1.19|1.52|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||1.52|-1.19|0.8137
73908322|NCT02963935|147346613|OTHER||Treatment difference|0.16||||0.8053|TWO_SIDED|95.0|-1.12|1.43|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg- placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||1.43|-1.12|0.8053
73908323|NCT02963935|147346614|SUPERIORITY|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|0.87||||0.6916|TWO_SIDED|95.0|-3.41|5.14|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||5.14|-3.41|0.6916
73908324|NCT02963935|147346614|OTHER||treatment difference|1.25||||0.5572|TWO_SIDED|95.0|-2.95|5.45|||Mixed models repeated measurements (MMRM||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||5.45|-2.95|0.5572
73908325|NCT02963935|147346615|SUPERIORITY|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|3.12||||0.6986|TWO_SIDED|95.0|-12.68|18.92|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||18.92|-12.68|0.6986
73908326|NCT02963935|147346615|OTHER||Treatment difference|7.66||||0.37|TWO_SIDED|95.0|-9.15|24.48|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||24.48|-9.15|0.3700
73908327|NCT00464269|147346658|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|12.8|||=|0.025|TWO_SIDED|95.0|1.7|22.6|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to a 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam (BRV) dose and Placebo (PBO) is reported as a percent reduction over Placebo. The treatment effect was estimated using the 95 % confidence intervals.||22.6|1.7|=0.025
73908328|NCT00464269|147346658|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|4.1|||=|0.492|TWO_SIDED|95.0|-8.1|15.0|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam dose an Placebo is reported as a percent reduction over Placebo. The treatment effect was estimated using 95 % confidence intervals.||15.0|-8.1|=0.492
73908329|NCT01385371|147346689|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.98|||<|0.001||95.0|-1.2|-0.4|||Wilcoxon Rank Sum Test|||||-0.4|-1.2|<0.001
73908330|NCT01385371|147346690|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64||||0.001|TWO_SIDED|95.0|-0.7|-0.2|||Wilcoxon Rank Sum Test|||||-0.2|-0.7|0.001
73908331|NCT01385371|147346691|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.33|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5|||Wilcoxon Rank Sum Test|||||-0.5|-1.4|<0.001
73908332|NCT01385371|147346692|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.13||||0.027||95.0|-0.2|0.0|||Wilcoxon Rank Sum Test|||||0.0|-0.2|0.027
73908333|NCT01385371|147346693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0003|TWO_SIDED|95.0|-0.73|-0.22||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (\<18 or \>=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model|||||-0.22|-0.73|0.0003
73964520|NCT04992390|147464629|SUPERIORITY|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the immediate intervention arm, comparing pre-intervention (run-in/screening week) to post-intervention (week 4).|Incidence Rate Ratio|0.22|||<|0.001|TWO_SIDED|95.0|0.1|0.45||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories pre- to post-intervention.||Within the immediate intervention arm, where participants had immediate access to the intervention, the number of intrusive memories in Week 4 was compared to the run-in/screening week. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0||0.45|0.10|<0.001
73857071|NCT05425732|147259535|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.92|1.21|||cLDA model||V116/PCV20|Serotype 12F: V116/PCV20 GMT Ratio||1.21|0.92|<0.001
73857072|NCT05425732|147259535|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.69|0.84|||cLDA model||V116/PCV20|Serotype 19A: V116/PCV20 GMT Ratio||0.84|0.69|<0.001
73857073|NCT05425732|147259535|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.72|0.92|||cLDA model||V116/PCV20|Serotype 22F: V116/PCV20 GMT Ratio||0.92|0.72|<0.001
73857074|NCT05425732|147259535|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.01|1.32|||cLDA model||V116/PCV20|Serotype 33F: V116/PCV20 GMT Ratio||1.32|1.01|<0.001
73857075|NCT05425732|147259535|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|4.55|||<|0.001|TWO_SIDED|95.0|4.12|5.04|||cLDA model||V116/PCV20|Serotype 9N: V116/PCV20 GMT Ratio||5.04|4.12|<0.001
73857076|NCT05425732|147259535|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|3.3|||<|0.001|TWO_SIDED|95.0|2.91|3.74|||cLDA model||V116/PCV20|Serotype 15A: V116/PCV20 GMT Ratio||3.74|2.91|<0.001
73857077|NCT05425732|147259535|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|2.03|||<|0.001|TWO_SIDED|95.0|1.77|2.34|||cLDA model||V116/PCV20|Serotype 15C: V116/PCV20 GMT Ratio||2.34|1.77|<0.001
73857078|NCT05425732|147259535|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|5.75|||<|0.001|TWO_SIDED|95.0|5.16|6.41|||cLDA model||V116/PCV20|Serotype 16F: V116/PCV20 GMT Ratio||6.41|5.16|<0.001
73857079|NCT05425732|147259535|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|16.86|||<|0.001|TWO_SIDED|95.0|14.9|19.09|||cLDA model||V116/PCV20|Serotype 17F: V116/PCV20 GMT Ratio||19.09|14.90|<0.001
73908334|NCT01385371|147346694|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||Wilcoxon Rank Sum Test|||||-0.2|-0.9|<0.001
73908335|NCT01385371|147346695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0001|TWO_SIDED|95.0|-0.94|-0.31||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (\<18 or \>=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model|||||-0.31|-0.94|0.0001
73908336|NCT01385371|147346696|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.15||||0.644|TWO_SIDED|95.0|-0.4|0.6|||Wilcoxon Rank Sum Test|||||0.6|-0.4|0.644
73908337|NCT02478372|147346697|SUPERIORITY_OR_OTHER|||||||0.332|TWO_SIDED|||||Significance was set at \<0.01|Chi-squared|||||||0.332
73908338|NCT02955797|147346706|NON_INFERIORITY|95% confidence interval (CI) was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was greater than (\>) -10%.|Percentage difference|-2.03|||||TWO_SIDED|95.0|-5.84|1.78||||||Serogroup A||1.78|-5.84|
73908339|NCT02955797|147346706|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|12.1|||||TWO_SIDED|95.0|8.16|16.1||||||Serogroup C||16.1|8.16|
73908340|NCT02955797|147346706|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|2.42|||||TWO_SIDED|95.0|-1.34|6.19||||||Serogroup Y||6.19|-1.34|
73908341|NCT02955797|147346706|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|0.458|||||TWO_SIDED|95.0|-4.37|5.28||||||Serogroup W||5.28|-4.37|
73971212|NCT06044090|147482981|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
73971213|NCT06044090|147482981|SUPERIORITY|||||||0.691|||||||t-test, 2 sided|||||||0.691
73971214|NCT06044090|147482982|SUPERIORITY|||||||0.225|||||||t-test, 2 sided|||||||0.225
73971215|NCT06044090|147482982|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
73971216|NCT05698875|147483000|OTHER||Fixed effects parameter|1.0||||0.12|TWO_SIDED|95.0|0.1|1.9||P=0.04 however was adjusted using the Bonferroni correction The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs control meals||1.9|0.1|0.12
73971217|NCT05698875|147483000|OTHER||Fixed effects parameter|-0.58||||0.23|TWO_SIDED|95.0|-1.5|0.4||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP vs control meal||0.4|-1.5|0.23
73971218|NCT05698875|147483000|OTHER||Fixed effects parameter|0.24||||0.62|TWO_SIDED|95.0|-0.7|1.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL vs control meal||1.2|-0.7|0.62
73971219|NCT05698875|147483000|OTHER||Fixed effects parameter|1.6||||0.003|TWO_SIDED|95.0|0.7|2.5||Above is adjusted p value using Bonferroni correction. The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs HGLP||2.5|0.7|0.003
73971220|NCT05698875|147483000|OTHER||Fixed effects parameter|0.82||||0.08|TWO_SIDED|95.0|-0.1|1.7||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs MGL meals||1.7|-0.1|0.08
74085203|NCT02156154|147724013|SUPERIORITY||Mean Difference (Net)|-0.08||||0.3|TWO_SIDED|99.4|-0.29|0.13||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as differences in means between the study groups, assessed using a 2-sample t test.|||0.13|-0.29|0.30
73857080|NCT05425732|147259535|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|9.66|||<|0.001|TWO_SIDED|95.0|8.66|10.79|||cLDA model||V116/PCV20|Serotype 20A: V116/PCV20 GMT Ratio||10.79|8.66|<0.001
73857081|NCT05425732|147259535|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|8.1|||<|0.001|TWO_SIDED|95.0|6.86|9.55|||cLDA model||V116/PCV20|Serotype 23A: V116/PCV20 GMT Ratio||9.55|6.86|<0.001
73857082|NCT05425732|147259535|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|10.09|||<|0.001|TWO_SIDED|95.0|8.48|12.0|||cLDA model||V116/PCV20|Serotype 23B: V116/PCV20 GMT Ratio||12.00|8.48|<0.001
73857083|NCT05425732|147259535|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|38.71|||<|0.001|TWO_SIDED|95.0|33.87|44.25|||cLDA model||V116/PCV20|Serotype 24F: V116/PCV20 GMT Ratio||44.25|33.87|<0.001
73857084|NCT05425732|147259535|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|21.69|||<|0.001|TWO_SIDED|95.0|18.68|25.18|||cLDA model||V116/PCV20|Serotype 31: V116/PCV20 GMT Ratio||25.18|18.68|<0.001
73857085|NCT05425732|147259535|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|6.17|||<|0.001|TWO_SIDED|95.0|5.59|6.8|||cLDA model||V116/PCV20|Serotype 35B: V116/PCV20 GMT Ratio||6.80|5.59|<0.001
73857086|NCT05425732|147259536|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|44.7|||<|0.001|TWO_SIDED|95.0|40.7|48.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 9N: V116-PCV20 Percentage Difference||48.6|40.7|<0.001
73857087|NCT05425732|147259536|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|30.9|||<|0.001|TWO_SIDED|95.0|25.8|35.8||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 15A: V116-PCV20 Percentage Difference||35.8|25.8|<0.001
73857088|NCT05425732|147259536|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|9.2|||<|0.001|TWO_SIDED|95.0|5.6|12.9||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 15C: V116-PCV20 Percentage Difference||12.9|5.6|<0.001
73857089|NCT05425732|147259536|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|51.1|||<|0.001|TWO_SIDED|95.0|47.1|54.9||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 16F: V116-PCV20 Percentage Difference||54.9|47.1|<0.001
73857090|NCT05425732|147259536|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|66.3|||<|0.001|TWO_SIDED|95.0|62.8|69.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 17F: V116-PCV20 Percentage Difference||69.6|62.8|<0.001
73857091|NCT05425732|147259536|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|57.7|||<|0.001|TWO_SIDED|95.0|54.2|61.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 20A: V116-PCV20 Percentage Difference||61.1|54.2|<0.001
73857092|NCT05425732|147259536|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|42.2|||<|0.001|TWO_SIDED|95.0|37.6|46.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 23A: V116-PCV20 Percentage Difference||46.6|37.6|<0.001
73857093|NCT05425732|147259536|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|35.9|||<|0.001|TWO_SIDED|95.0|32.1|39.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 23B: V116-PCV20 Percentage Difference||39.6|32.1|<0.001
73857094|NCT05425732|147259536|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|74.2|||<|0.001|TWO_SIDED|95.0|71.1|77.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype24F: V116-PCV20 Percentage Difference||77.1|71.1|<0.001
73971221|NCT05698875|147483000|OTHER||Fixed effects parameter|-0.8||||0.12|TWO_SIDED|95.0|-1.7|0.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.2|-1.7|0.12
73971222|NCT05698875|147483001|OTHER||Mean Difference (Final Values)|0.835||||0.08|TWO_SIDED|95.0|-0.1|1.8||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs control meals||1.8|-0.1|0.08
73971223|NCT05698875|147483001|OTHER||Mean Difference (Final Values)|-0.7||||0.13|TWO_SIDED|95.0|-1.7|0.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meal vs control meal||0.2|-1.7|0.13
73971224|NCT05698875|147483001|OTHER||Mean Difference (Final Values)|-0.2||||0.68|TWO_SIDED|95.0|-1.2|0.8||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||0.8|-1.2|0.68
73971225|NCT05698875|147483001|OTHER||Mean Difference (Final Values)|1.6|||<|0.01|TWO_SIDED|95.0|0.7|2.5||The a priori threshold for statistical significance p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||2.5|0.7|<0.01
73971226|NCT05698875|147483001|OTHER||Mean Difference (Final Values)|1.1||||0.06|TWO_SIDED|95.0|0.2|2.0||The a priori threshold for statistical significance p\<0.05 p value adjusted with the Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||2.0|0.2|0.06
73857095|NCT05425732|147259536|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|58.6|||<|0.001|TWO_SIDED|95.0|54.8|62.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 31: V116-PCV20 Percentage Difference||62.1|54.8|<0.001
73971227|NCT05698875|147483001|OTHER||Mean Difference (Final Values)|-0.5||||0.29|TWO_SIDED|95.0|-1.4|0.4||a priori threshold for statistical significance - P\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.4|-1.4|0.29
73971228|NCT05698875|147483002|OTHER||Mean Difference (Final Values)|1.9|||<|0.01|TWO_SIDED|95.0|0.8|3.0||The a priori threshold for statistical significance p\<0.05 Adjusted p value with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||3.0|0.8|<0.01
73971229|NCT05698875|147483002|OTHER||Mean Difference (Final Values)|-0.3||||0.59|TWO_SIDED|95.0|-1.4|0.8||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.8|-1.4|0.59
73971230|NCT05698875|147483002|OTHER||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.2|1.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.0|-1.2|0.86
73857096|NCT05425732|147259536|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|53.2|||<|0.001|TWO_SIDED|95.0|49.6|56.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype35B: V116-PCV20 Percentage Difference||56.6|49.6|<0.001
73857097|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.9|1.33||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 3: V116 18-49 years/V116 50-64 years GMT Ratio||1.33|0.90|<0.001
73857098|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.06|||<|0.001|TWO_SIDED|95.0|1.61|2.62||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 6A: V116 18-49 years/V116 50-64 years GMT Ratio||2.62|1.61|<0.001
73857099|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.51|||<|0.001|TWO_SIDED|5.0|1.23|1.84||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 7F: V116 18-49 years/V116 50-64 years GMT Ratio||1.84|1.23|<0.001
73857100|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.5|||<|0.001|TWO_SIDED|95.0|1.26|1.79||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 8: V116 18-49 years/V116 50-64 years GMT Ratio||1.79|1.26|<0.001
73857101|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.97|||<|0.001|TWO_SIDED|95.0|1.59|2.43||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 9N: V116 18-49 years/V116 50-64 years GMT Ratio||2.43|1.59|<0.001
73971231|NCT05698875|147483002|OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.2|3.3||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs HGLP meals||3.3|1.2|<0.001
73971232|NCT05698875|147483002|OTHER||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.1|3.1||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction did not alter p value|Linear Mixed Model|||HGL vs MGL meals||3.1|1.1|<0.001
73971233|NCT05698875|147483002|OTHER||Mean Difference (Final Values)|-0.1||||0.79|TWO_SIDED|95.0|-1.2|0.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.9|-1.2|0.79
73971234|NCT05698875|147483003|OTHER||Mean Difference (Final Values)|-8.5||||0.31|TWO_SIDED|95.0|-25.0|8.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGL meals vs control meals||8|-25|0.31
73971235|NCT05698875|147483003|OTHER||Mean Difference (Final Values)|-24.4||||0.03|TWO_SIDED|95.0|-41.0|-8.0||A priori threshold for statistical significance is p\<0.05 P adjusted using Bonferroni correction|Linear Mixed Model|||HGLP meals vs control meals||-8|-41|0.03
73971236|NCT05698875|147483003|OTHER||Mean Difference (Final Values)|12.7||||0.14|TWO_SIDED|95.0|-4.1|29.5||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||29.5|-4.1|0.14
73971237|NCT05698875|147483003|OTHER||Mean Difference (Final Values)|17.0||||0.34|TWO_SIDED|95.0|3.1|31.7||A priori threshold P \<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||31.7|3.1|0.34
73971238|NCT05698875|147483003|OTHER||Mean Difference (Final Values)|-19.0||||0.07|TWO_SIDED|95.0|-33.3|-4.7||A priori threshold for statistical significance is p\<0.05 Adjusted P value with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||-4.7|-33.3|0.07
73971239|NCT05698875|147483003|OTHER||Mean Difference (Final Values)|-36.4|||<|0.001|TWO_SIDED|95.0|-51.0|-21.8||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGLP vs MGL meals||-21.8|-51.0|<0.001
73971240|NCT05698875|147483004|OTHER||Mean Difference (Final Values)|151.0||||0.25|TWO_SIDED|95.0|7.0|294.0||A priori threshold for statistical significance is p\<0.05 Adjusted p value with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||294|7|0.25
73857102|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.92||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 10A: V116 18-49 years/V116 50-64 years GMT Ratio||1.92|1.26|<0.001
73857103|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.91||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 11A: V116 18-49 years/V116 50-64 years GMT Ratio||1.91|1.26|<0.001
73857104|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.73|||<|0.001|TWO_SIDED|95.0|1.37|2.17||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 12F: V116 18-49 years/V116 50-64 years GMT Ratio||2.17|1.37|<0.001
73857105|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.92|||<|0.001|TWO_SIDED|95.0|1.55|2.37||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15A: V116 18-49 years/V116 50-64 years GMT Ratio||2.37|1.55|<0.001
73857106|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.36|2.35||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15C: V116 18-49 years/V116 50-64 years GMT Ratio||2.35|1.36|<0.001
73857107|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.91||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 16F: V116 18-49 years/V116 50-64 years GMT Ratio||1.91|1.26|<0.001
73857108|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.26|2.02||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 17F: V116 18-49 years/V116 50-64 years GMT Ratio||2.02|1.26|<0.001
73857109|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.17|||<|0.001|TWO_SIDED|95.0|0.97|1.4||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 19A: V116 18-49 years/V116 50-64 years GMT Ratio||1.40|0.97|<0.001
73857110|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.74|||<|0.001|TWO_SIDED|95.0|1.39|2.18||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 20A: V116 18-49 years/V116 50-64 years GMT Ratio||2.18|1.39|<0.001
73857111|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.99|||<|0.001|TWO_SIDED|95.0|1.58|2.49||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 22F: V116 18-49 years/V116 50-64 years GMT Ratio||2.49|1.58|<0.001
73857112|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.87|||<|0.001|TWO_SIDED|95.0|1.43|2.44||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 23A: V116 18-49 years/V116 50-64 years GMT Ratio||2.44|1.43|<0.001
73857113|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.51|||<|0.001|TWO_SIDED|95.0|1.11|2.04||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 23B: V116 18-49 years/V116 50-64 years GMT Ratio||2.04|1.11|<0.001
73857114|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.36|||<|0.001|TWO_SIDED|95.0|1.1|1.67||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 24F: V116 18-49 years/V116 50-64 years GMT Ratio||1.67|1.10|<0.001
73857115|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.63|2.69||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 31: V116 18-49 years/V116 50-64 years GMT Ratio||2.69|1.63|<0.001
73857116|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.98|||<|0.001|TWO_SIDED|95.0|1.52|2.57||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 33F: V116 18-49 years/V116 50-64 years GMT Ratio||2.57|1.52|<0.001
73857117|NCT05425732|147259537|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.26|1.87||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 35B: V116 18-49 years/V116 50-64 years GMT Ratio||1.87|1.26|<0.001
73971241|NCT05698875|147483004|OTHER||Mean Difference (Final Values)|-109.0||||0.15|TWO_SIDED|95.0|-256.0|38.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||38|-256|0.15
73971242|NCT05698875|147483004|OTHER||Mean Difference (Final Values)|-30.0||||0.69|TWO_SIDED|95.0|-177.0|117.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||117|-177|0.69
73971243|NCT05698875|147483004|OTHER||Mean Difference (Final Values)|264.0|||<|0.001|TWO_SIDED|95.0|126.0|401.0||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs HGLP meals||401|126|<0.001
73908342|NCT02955797|147346707|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|1.3|||||TWO_SIDED|95.0|-3.6|6.2||||||Serogroup A||6.2|-3.6|
73908343|NCT02955797|147346707|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|18.0|||||TWO_SIDED|95.0|13.6|22.8||||||Serogroup C||22.8|13.6|
73908344|NCT02955797|147346707|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|1.6|||||TWO_SIDED|95.0|-2.76|6.03||||||Serogroup Y||6.03|-2.76|
73908345|NCT02955797|147346707|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|0.2|||||TWO_SIDED|95.0|-5.85|6.18||||||Serogroup W||6.18|-5.85|
73908346|NCT02955797|147346708|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an analysis of variance (ANOVA) model of log10-transformed titers.|GMT Ratio|0.819|||||TWO_SIDED|95.0|0.697|0.963||||||Serogroup A||0.963|0.697|
73971244|NCT05698875|147483004|OTHER||Mean Difference (Final Values)|192.0||||0.02|TWO_SIDED|95.0|56.0|329.0||A priori threshold for statistical significance is p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||329|56|0.02
73908347|NCT02955797|147346708|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|7.59|||||TWO_SIDED|95.0|6.05|9.52||||||Serogroup C||9.52|6.05|
73908348|NCT02955797|147346708|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.09|1.51||||||Serogroup Y||1.51|1.09|
73908349|NCT02955797|147346708|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|1.32|||||TWO_SIDED|95.0|1.12|1.56||||||Serogroup W||1.56|1.12|
73908350|NCT02955797|147346709|OTHER||GMT Ratio|1.03|||||TWO_SIDED|95.0|0.85|1.24||||||Serogroup A||1.24|0.85|
73908351|NCT02955797|147346709|OTHER||GMT Ratio|16.5|||||TWO_SIDED|95.0|13.4|20.4||||||Serogroup C||20.4|13.4|
73908352|NCT02955797|147346709|OTHER||GMT Ratio|1.18|||||TWO_SIDED|95.0|0.97|1.44||||||Serogroup Y||1.44|0.97|
73908353|NCT02955797|147346709|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.1|1.63||||||Serogroup W||1.63|1.1|
73908354|NCT02955797|147346710|OTHER||GMT Ratio|0.496|||||TWO_SIDED|95.0|0.367|0.672||||||Serogroup A||0.672|0.367|
73908355|NCT02955797|147346710|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|0.814|2.19||||||Serogroup C||2.19|0.814|
73908356|NCT02955797|147346710|OTHER||GMT Ratio|1.53|||||TWO_SIDED|95.0|1.15|2.04||||||Serogroup Y||2.04|1.15|
73908357|NCT02955797|147346710|OTHER||GMT Ratio|1.29|||||TWO_SIDED|95.0|0.944|1.75||||||Serogroup W||1.75|0.944|
73908358|NCT01498978|147346715|OTHER|Exact binomial test (two-sided).||||||0.754|||||||Exact Binomial Test|||Exact binomial test (two-sided). Null hypothesis: the proportion is equal to 0.5||||0.754
73908359|NCT01498978|147346716|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.19|||||||Fisher Exact|||||||0.190
73971245|NCT05698875|147483004|OTHER||Mean Difference (Final Values)|-71.0||||0.32|TWO_SIDED|95.0|-211.0|69.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||69|-211|0.32
73971246|NCT05698875|147483005|OTHER||Mean Difference (Final Values)|6.9|||<|0.01|TWO_SIDED|95.0|3.3|10.4||A priori threshold for statistical significance is p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||10.4|3.3|<0.01
73971247|NCT05698875|147483005|OTHER||Mean Difference (Final Values)|3.5||||0.06|TWO_SIDED|95.0|-0.2|7.2||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||7.2|-0.2|0.06
73971248|NCT05698875|147483005|OTHER||Mean Difference (Final Values)|0.32||||0.86|TWO_SIDED|95.0|-3.3|3.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||3.9|-3.3|0.86
73971249|NCT05698875|147483005|OTHER||Mean Difference (Final Values)|3.4||||0.11|TWO_SIDED|95.0|0.24|6.48||A priori threshold for statistical significance is p\<0.05 P value adjusted with the Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||6.48|0.24|0.11
73971250|NCT05698875|147483005|OTHER||Mean Difference (Final Values)|6.7|||<|0.001|TWO_SIDED|95.0|3.6|9.8||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs MGL meals||9.8|3.6|<0.001
73971251|NCT05698875|147483005|OTHER||Mean Difference (Final Values)|3.3||||0.13|TWO_SIDED|95.0|0.2|6.5||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGLP vs MGL meals||6.5|0.2|0.13
73971252|NCT05698875|147483006|OTHER||Mean Difference (Final Values)|-34.8||||0.01|TWO_SIDED|95.0|-55.9|-13.6||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meal||-13.6|-55.9|0.01
73971253|NCT05698875|147483006|OTHER||Mean Difference (Final Values)|-1.8||||0.87|TWO_SIDED|95.0|-23.6|19.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||19.9|-23.6|0.87
73971254|NCT05698875|147483006|OTHER||Mean Difference (Final Values)|-4.7||||0.67|TWO_SIDED|95.0|-26.4|17.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||17.0|-26.4|0.67
73971255|NCT05698875|147483006|OTHER||Mean Difference (Final Values)|-33.3||||0.01|TWO_SIDED|95.0|-54.4|-12.2||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||-12.2|-54.4|0.01
73971256|NCT05698875|147483006|OTHER||Mean Difference (Final Values)|-31.4||||0.01|TWO_SIDED|95.0|-52.4|-10.4||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||-10.4|-52.4|0.01
74085204|NCT02156154|147724014|SUPERIORITY||Ratios of geometric means|0.94||||0.65|TWO_SIDED|99.4|0.63|1.39||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as ratios of geometric means, assessed using a 2-sample t test after logarithmic transformation of outcomes.|||1.39|0.63|0.65
73857118|NCT05425732|147259538|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4-fold rise from baseline to 30 days postvaccination being \> 50 percentage points (one-sided p-value \< 0.025)."||||||0.667||||||1-sided|Clopper-Pearson method.|||Serotype 6C||||0.667
73857119|NCT05425732|147259538|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4-fold rise from baseline to 30 days postvaccination being \> 50 percentage points (one-sided p-value \< 0.025)."|||||<|0.001||||||1-sided|Clopper-Pearson method.|||Serotype 15B||||<0.001
73857120|NCT05425732|147259539|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.05|||||TWO_SIDED|95.0|1.52|2.77|||||V116 18-49 years/V116 50-64 years|Serotype 6C: V116 18-49 years/V116 50-64 years GMT Ratio||2.77|1.52|
73857121|NCT05425732|147259539|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT|2.02|||<|0.001|TWO_SIDED|95.0|1.57|2.6||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15B: V116 18-49 years/V116 50-64 years GMT ratio||2.60|1.57|<0.001
73857122|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|1.47|||||TWO_SIDED|95.0|1.35|1.6|||||V116/PCV20|Serotype 3: V116/PCV20 GMC Ratio||1.60|1.35|
73857123|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.7|0.89|||||V116/PCV20|Serotype 6A: V116/PCV20 GMC Ratio||0.89|0.70|
73857124|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.95|1.18|||||V116/PCV20|Serotype 7F: V116/PCV20 GMC Ratio||1.18|0.95|
73857125|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.29|1.59|||||V116/PCV20|Serotype 8: V116/PCV20 GMC Ratio||1.59|1.29|
73857126|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.92|||||V116/PCV20|Serotype 10A: V116/PCV20 GMC Ratio||0.92|0.72|
73857127|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|1.23|||||TWO_SIDED|95.0|1.11|1.36|||||V116/PCV20|Serotype 11A: V116/PCV20 GMC Ratio||1.36|1.11|
73857128|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26|||||V116/PCV20|Serotype 12F: V116/PCV20 GMC Ratio||1.26|0.96|
73857129|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|0.7|||||TWO_SIDED|95.0|0.63|0.77|||||V116/PCV20|Serotype 19A: V116/PCV20 GMC Ratio||0.77|0.63|
73857130|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9|||||V116/PCV20|Serotype 22F: V116/PCV20 GMC Ratio||0.90|0.72|
73857131|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.95|1.18|||||V116/PCV20|Serotype 33F: V116/PCV20 GMC Ratio||1.18|0.95|
73857132|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|5.41|||||TWO_SIDED|95.0|4.82|6.06|||||V116/PCV20|Serotype 9N: V116/PCV20 GMC Ratio||6.06|4.82|
73857133|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|6.79|||||TWO_SIDED|95.0|6.03|7.64|||||V116/PCV20|Serotype 15A: V116/PCV20 GMC Ratio||7.64|6.03|
73857134|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|2.46|||||TWO_SIDED|95.0|2.17|2.79|||||V116/PCV20|Serotype 15C: V116/PCV20 GMC Ratio||2.79|2.17|
73857135|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|8.75|||||TWO_SIDED|95.0|7.95|9.64|||||V116/PCV20|Serotype 16F: V116/PCV20 GMC Ratio||9.64|7.95|
73857136|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|16.75|||||TWO_SIDED|95.0|15.25|18.41|||||V116/PCV20|Serotype 17F: V116/PCV20 GMC Ratio||18.41|15.25|
73857137|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|12.92|||||TWO_SIDED|5.0|11.81|14.13|||||V116/PCV20|Serotype 20A: V116/PCV20 GMC Ratio||14.13|11.81|
73857138|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|6.42|||||TWO_SIDED|95.0|5.69|7.24|||||V116/PCV20|Serotype 23A: V116/PCV20 GMC Ratio||7.24|5.69|
73857139|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|3.25|||||TWO_SIDED|95.0|2.91|3.64|||||V116/PCV20|Serotype 23B: V116/PCV20 GMC Ratio||3.64|2.91|
73857140|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|21.08|||||TWO_SIDED|85.0|18.97|23.43|||||V116/PCV20|Serotype 24F: V116/PCV20 GMC Ratio||23.43|18.97|
73857141|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|11.31|||||TWO_SIDED|95.0|10.36|12.34|||||V116/PCV20|Serotype 31: V116/PCV20 GMC Ratio||12.34|10.36|
73857142|NCT05425732|147259540|OTHER|cLDA model|GMC Ratio|14.13|||||TWO_SIDED|95.0|12.97|15.4|||||V116/PCV20|Serotype 35B: V116/PCV20 GMC Ratio||15.40|12.97|
73857143|NCT02998203|147259545|OTHER|One-sample t-test|||||<|0.001|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||<0.001
73857144|NCT02998203|147259546|OTHER|non-parametric Wilcoxon rank sum test|||||<|0.001|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||<0.001
73857145|NCT02998203|147259547|OTHER|Linear mixed-effect regression model|||||<|0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||<0.001
73857146|NCT02998203|147259548|OTHER|Wilcoxon rank sum test||||||0.017|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.017
73857147|NCT02998203|147259549|OTHER|Logistic mixed-effect model||||||0.014||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||0.014
73971257|NCT05698875|147483006|OTHER||Mean Difference (Final Values)|1.86||||0.87|TWO_SIDED|95.0|-19.7|23.4||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||23.4|-19.7|0.87
74085205|NCT02156154|147724015|SUPERIORITY||Ratios of geometric means|0.86||||0.22|TWO_SIDED|99.4|0.61|1.21|||t-test, 2 sided||Treatment effect data are reported as ratios of geometric means, assessed using a 2-sample t test after logarithmic transformation of outcomes.|||1.21|0.61|0.22
74026023|NCT02158533|147605099|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.17||0.975|TWO_SIDED|95.0|-2.3|2.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 0.5mg/0.5mg was compared to placebo (i.e., ALKS 5461 0.5mg/0.5mg S1 vs Placebo S1; and ALKS 5461 0.5mg/0.5mg S2 vs Placebo S2). The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5/0.5 compared to placebo.||2.3|-2.3|0.975
74026024|NCT01335971|147605130|SUPERIORITY_OR_OTHER|||||||0.45|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in alveolar macrophages||||0.45
74026025|NCT01335971|147605130|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in alveolar macrophages||||0.40
74026026|NCT01335971|147605130|SUPERIORITY_OR_OTHER|||||||0.75|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in alveolar macrophages||||0.75
74026027|NCT01335971|147605130|SUPERIORITY_OR_OTHER|||||||0.49|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in alveolar macrophages||||0.49
74026028|NCT01335971|147605130|SUPERIORITY_OR_OTHER|||||||0.88|||||||Kruskal-Wallis|||Applies to gene expression of nuclear factor erythroid 2 like 2 (Nrf2) in alveolar macrophages||||0.88
74026029|NCT01335971|147605130|SUPERIORITY_OR_OTHER|||||||0.71|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in alveolar macrophages||||0.71
74026030|NCT01335971|147605131|SUPERIORITY_OR_OTHER|||||||0.68|||||||Kruskal-Wallis|||Applies to gene expression of Nrf2 in bronchial epithelial cells||||0.68
74026031|NCT01335971|147605132|SUPERIORITY_OR_OTHER|||||||0.69|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in bronchial epithelial cells||||0.69
74026032|NCT01335971|147605132|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in bronchial epithelial cells||||<0.01
74026033|NCT01335971|147605133|SUPERIORITY_OR_OTHER|||||||0.53|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells||||0.53
74026034|NCT01335971|147605134|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells.||||<0.01
74026035|NCT01335971|147605135|SUPERIORITY_OR_OTHER|||||||0.06|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells.||||0.06
74026036|NCT01335971|147605136|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.20
73857148|NCT02998203|147259550|OTHER|One-sample t-test||||||0.167|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.167
74085206|NCT02156154|147724016|SUPERIORITY||Risk Ratio (RR)|1.13||||0.18|TWO_SIDED|99.4|0.88|1.45||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Chi-squared||Risk ratio = Treatment/Placebo|||1.45|0.88|0.18
73857149|NCT02998203|147259551|OTHER|Wilcoxon rank sum test||||||0.07|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.07
73908360|NCT01498978|147346719|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.5|||||||Fisher Exact|||||||0.500
73908361|NCT01498978|147346720|OTHER|Test of association (contingency) between the two kinds of classification.||||||1|||||||Fisher Exact|||||||1.000
74026037|NCT01335971|147605137|SUPERIORITY_OR_OTHER|||||||0.41|||||||Kruskal-Wallis|||Applies to C-reactive protein concentration||||0.41
74026038|NCT01335971|147605137|SUPERIORITY_OR_OTHER|||||||0.07|||||||Kruskal-Wallis|||Applies to Interleukin-6 concentration||||0.07
74026039|NCT01335971|147605137|SUPERIORITY_OR_OTHER|||||||0.65|||||||Kruskal-Wallis|||Applies to Interleukin-8 concentration||||0.65
74026040|NCT01335971|147605138|SUPERIORITY_OR_OTHER|||||||0.71|||||||Kruskal-Wallis|||Applies to interleukin-8 results||||0.71
74026041|NCT01335971|147605138|SUPERIORITY_OR_OTHER|||||||0.33|||||||Kruskal-Wallis|||Applies to secretory leukoprotease inhibitor results||||0.33
74026042|NCT01335971|147605139|SUPERIORITY_OR_OTHER|||||||0.8|||||||Kruskal-Wallis|||Applies to isoprostane results.||||0.80
74026043|NCT01335971|147605139|SUPERIORITY_OR_OTHER|||||||0.35|||||||Kruskal-Wallis|||Applies to thiobarbituric acid reactive substances results.||||0.35
74026044|NCT01335971|147605139|SUPERIORITY_OR_OTHER|||||||0.53|||||||Kruskal-Wallis|||Applies to total antioxidants results.||||0.53
74026045|NCT00917384|147605149|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.776||||0.0473||95.0|0.603|0.998|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).||||0.998|0.603|0.0473
74026046|NCT00917384|147605150|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.483|||<|0.0001|TWO_SIDED|95.0|0.376|0.62|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).||||0.620|0.376|<0.0001
74026047|NCT00917384|147605151|SUPERIORITY_OR_OTHER_LEGACY||Difference Between Arms|24.2|||<|0.0001|TWO_SIDED|95.0|14.9|33.6|||Normal Approximation|||||33.6|14.9|<0.0001
74085207|NCT02156154|147724017|SUPERIORITY||Risk Ratio (RR)|0.9||||0.53|TWO_SIDED|99.4|0.57|1.43||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Chi-squared||RR = Treatment/Placebo|||1.43|0.57|0.53
74085208|NCT02156154|147724018|SUPERIORITY||Median Difference (Final Values)|0.0||||0.99|TWO_SIDED|99.4|-0.39|0.36||Adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Wilcoxon (Mann-Whitney)||Treatment effect is reported as median difference, estimated using the Hodges-Lehmann estimator of location shift.|||0.36|-0.39|0.99
73971258|NCT05698875|147483007|OTHER||Mean Difference (Final Values)|34.0||||0.04|TWO_SIDED|95.0|2.0|65.0|||t-test, 2 sided|||Control vs HGL meals||65|2|0.04
73971259|NCT05698875|147483007|OTHER||Mean Difference (Final Values)|6.0||||0.56|TWO_SIDED|95.0|-17.0|30.0|||t-test, 2 sided|||Control vs HGLP meals||30|-17|0.56
73857150|NCT02998203|147259552|OTHER|Linear mixed-effect regression model||||||0.014||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||0.014
73857151|NCT02998203|147259553|OTHER|One-sample t-test||||||0.023|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.023
73857152|NCT02998203|147259554|OTHER|Wilcoxon rank sum test||||||0.259|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.259
73857153|NCT02998203|147259555|OTHER|Linear mixed-effect regression model|||||<|0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||The interaction term for time and treatment was included in the models since it met the threshold of p-value\<0. 05. Specifically, for the interaction term of time and organic treatment b=-0.016, 95% CI=\[-0.023,-0.010\], p-value=\<0.001.||||<0.001
73857154|NCT02998203|147259556|OTHER|One-sample t-test||||||0.913|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.913
73857155|NCT02998203|147259557|OTHER|Wilcoxon rank sum test||||||0.338|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.338
73857156|NCT02998203|147259558|OTHER|Linear mixed-effect regression model||||||0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||The interaction term for time and treatment was included in the models since it met the threshold of p-value\<0. 05. Specifically, for the interaction term of time and organic treatment b=-0.016, 95% CI=\[-0.023,-0.010\], p-value=0.01.||||0.001
73857157|NCT04187144|147259559|NON_INFERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the 2.098 Z-statistic boundary.|Adjusted Difference in Percent|14.6|||||TWO_SIDED|95.0|6.4|22.8|||||||Observed Z statistic value for Noninferiority was 5.8838.|22.8|6.4|
73857158|NCT04187144|147259559|SUPERIORITY||Adjusted difference in Percent|14.6||||0.0003|TWO_SIDED|95.0|6.4|22.8|||1-sided p-value for Test of Superiority|||The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.018 p-value boundary||22.8|6.4|0.0003
73857159|NCT02743949|147259598|SUPERIORITY||Wilcoxon-Mann-Whitney odds estimator|1.0584||||0.748|TWO_SIDED|97.5|0.71|1.5778||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test|||||1.5778|0.7100|0.7480
73857160|NCT02743949|147259598|SUPERIORITY||Wilcoxon-Mann-Whitney odds estimator|1.0975||||0.5985|TWO_SIDED|97.5|0.7368|1.6349||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test|||||1.6349|0.7368|0.5985
73857161|NCT02743949|147259599|SUPERIORITY||Miettinen-Nurminen|0.91||||0.782|TWO_SIDED|97.5|0.44|1.91||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square|||||1.91|0.44|0.782
73857162|NCT02743949|147259599|SUPERIORITY||Miettinen-Nurminen|0.96||||0.912|TWO_SIDED|97.5|0.46|2.01||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square|||||2.01|0.46|0.912
73863241|NCT02636946|147272686|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0166|TWO_SIDED|95.0|-1.28|-0.13|||MMRM|||Change from Baseline at Week 4: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||-0.13|-1.28|0.0166
73908362|NCT01498978|147346721|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.524|||||||Fisher Exact|||||||0.524
73908363|NCT01892865|147346741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.6||||0.024|TWO_SIDED|95.0|3.15|44.0|||t-test, 2 sided|||The null hypothesis was that there would be no difference in predictive imprecision for the end of the operative day between the two arms||44|3.15|0.024
73908364|NCT01892865|147346741|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.04|TWO_SIDED|95.0|1.01|1.34|||Poisson regression|||Null hypothesis: There would be no difference in throughput between the two arms||1.34|1.01|0.04
73908365|NCT01892865|147346742|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.04|TWO_SIDED|95.0|1.01|1.34|||Poisson Regression|||Null hypothesis was that there was no difference in throughput between the two scheduling methods||1.34|1.01|0.04
73908366|NCT01892865|147346743|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Null hypothesis: There would be no difference in personnel satisfaction between the groups||||0.04
73908367|NCT01892865|147346744|SUPERIORITY_OR_OTHER|||||||0.44|||||||Chi-squared|||Null hypothesis was that there would be no difference in the adverse event rates between the two scheduling methodologies||||0.44
73908368|NCT02160990|147346761|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
73908369|NCT02160990|147346762|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
73908370|NCT02160990|147346763|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||ANCOVA|||||||0.23
74026048|NCT00149214|147605160|SUPERIORITY_OR_OTHER||Percentage of Participants|16.5||||||95.0|10.5|24.2||||||Confidence Interval for pathological complete response in the Pemetrexed treatment arm.||24.2|10.5|
74026049|NCT00149214|147605160|SUPERIORITY_OR_OTHER||Percentage of Participants|20.2||||||95.0|13.4|28.5||||||Confidence Interval for pathological complete response in the Cyclophosphamide treatment group.||28.5|13.4|
73857163|NCT03389555|147259600|EQUIVALENCE|Equivalence margin: if confidence interval for mean difference between SOFA scores at 72 hour time-point for two groups overlaps 0 (p-value \> 0.05) scores considered to be equivalent. Note: The model estimates the mean difference in SOFA score at 72 hours between treatment and control groups, for those patient for whom a SOFA score could be calculated at the 72 hour time point (i.e patients that were alive at the 72 hour time point, 90 patients in the treatment and 88 patients in the control).|Mean Difference (Net)|-0.8||||0.12|TWO_SIDED|95.0|-1.7|0.2||A priori threshold for significance, p-value \< 0.05|Mixed Models Analysis|||The primary outcome was analyzed using a linear mixed-effects model where the correlation of within-patient repeated SOFA score measures was accounted for via the use of an unstructured variance-covariance matrix and linear contrasts. Covariates included age, sex, treatment group, time, and the interaction between treatment group and time. Study site was included as a random intercept. The model estimates the mean difference in SOFA score at 72 hours between treatment and control groups.||0.2|-1.7|0.12
73857164|NCT03389555|147259601|EQUIVALENCE|For the key secondary outcome of kidney failure, 200 patients were estimated to provide 94% power, assuming that 30% of participants in the treatment group and 55% in the placebo group would develop kidney failure. If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|3.0||||0.58|TWO_SIDED|95.0|-10.0|20.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of kidney failure in treatment group (intervention versus placebo) controlling for treatment site.||20.0|-10.0|0.58
73857165|NCT03389555|147259602|EQUIVALENCE|If confidence interval for hazard ratio crosses 0, hazard of death assumed to be equivalent in the two groups.|Hazard Ratio (HR)|1.3||||0.05|TWO_SIDED|95.0|0.8|2.2|||Regression, Cox|||Cox Regression controlling for site used to identify hazard ratio for outcome of death for treatment versus intervention group. Null hypothesis is that hazard ratio is 1.||2.2|0.8|0.05
73857166|NCT03389555|147259603|EQUIVALENCE|If the confidence interval for the median difference in ventilator free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|0.0|||>|0.99|TWO_SIDED|95.0|-1.9|1.9|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's ventilator free days.||1.9|-1.9|>0.99
73857167|NCT03389555|147259604|EQUIVALENCE|If the confidence interval for the median difference in shock free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|1.0||||0.02|TWO_SIDED|95.0|0.2|1.8|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's shock free days.||1.8|0.2|0.02
73857168|NCT03389555|147259605|EQUIVALENCE|If the confidence interval for the median difference in ICU free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|1.0||||0.69|TWO_SIDED|95.0|-3.0|6.0|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's ICU free days.||6.0|-3.0|0.69
73857169|NCT03389555|147259606|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|3.0||||0.55|TWO_SIDED|95.0|-10.0|20.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of hospital mortality in treatment group (intervention versus placebo) controlling for treatment site..||20.0|-10.0|0.55
73857170|NCT03389555|147259607|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|2.0||||0.8|TWO_SIDED|95.0|-10.0|10.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of ICU mortality in treatment group (intervention versus placebo) controlling for treatment site.||10.0|-10.0|0.80
73857171|NCT03389555|147259608|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|-12.0||||0.16|TWO_SIDED|95.0|-25.0|4.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of occurrence of delirium in treatment group (intervention versus placebo) controlling for treatment site.||4|-25|0.16
73857172|NCT03389555|147259609|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|-1.8||||0.82|TWO_SIDED|95.0|-18.0|14.0|||Regression, Logistic|||Logistic regression analysis evaluating home hospital disposition in survivors to hospital discharge in intervention versus placebo group controlling for treatment site.||14|-18|0.82
73857173|NCT00920218|147259622|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of ceellular immune (CMI) response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 2.|Fold increase over Control|32.31|||<|0.0001|TWO_SIDED|76.16|20.65|50.54|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A F1 Group/Placebo Group below (\<) 1.||50.54|20.65|<0.0001
73857174|NCT00920218|147259622|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of CMI response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 2.|Fold increase over Control|9.51|||<|0.0001|TWO_SIDED|76.16|6.07|14.9|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A F1 Group/Placebo Group \< 2.||14.9|6.07|<0.0001
73857175|NCT00920218|147259623|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 3.|Fold increase over Control|74.41|||<|0.0001|TWO_SIDED|76.16|33.12|167.17|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A 1 Group/Placebo Group \< 1.||167.17|33.12|<0.0001
74026050|NCT03351244|147605220|OTHER||Hazard Ratio (HR)|1.097||||0.7735|TWO_SIDED|95.0|0.585|2.056|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||2.056|0.585|0.7735
74026051|NCT03351244|147605220|OTHER||Hazard Ratio (HR)|0.91||||0.7809|TWO_SIDED|95.0|0.468|1.77|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.770|0.468|0.7809
74026052|NCT03351244|147605220|OTHER||Hazard Ratio (HR)|1.005||||0.9862|TWO_SIDED|95.0|0.576|1.753|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.753|0.576|0.9862
74026053|NCT03351244|147605221|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.38||||0.5289|TWO_SIDED|95.0|-0.809|1.57|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.570|-0.809|0.5289
73971260|NCT05698875|147483007|OTHER||Mean Difference (Final Values)|12.0||||0.22|TWO_SIDED|95.0|8.0|32.0|||t-test, 2 sided|||Control vs MGL meals||32|8|0.22
73971261|NCT05698875|147483007|OTHER||Mean Difference (Final Values)|38.0||||0.01|TWO_SIDED|95.0|10.0|67.0|||t-test, 2 sided|||HGL vs HGLP meals||67|10|0.01
74026054|NCT03351244|147605221|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.21||||0.744|TWO_SIDED|95.0|-1.055|1.475|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.475|-1.055|0.7440
74026055|NCT03351244|147605221|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.31||||0.5659|TWO_SIDED|95.0|-0.745|1.358|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.358|-0.745|0.5659
73857176|NCT00920218|147259623|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 3.|Fold increase over Control|42.2|||<|0.0001|TWO_SIDED|76.16|20.2|88.13|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A 1 Group/Placebo Group \< 1.||88.13|20.20|<0.0001
73857177|NCT01007435|147259632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.77|||<|0.0001|TWO_SIDED|95.0|3.19|7.14||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + methotrexate treatment groups.||7.14|3.19|<0.0001
73857178|NCT01007435|147259632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.0001|TWO_SIDED|95.0|2.47|5.55||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + placebo to methotrexate treatment groups.||5.55|2.47|<0.0001
73857179|NCT01007435|147259632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.72|||<|0.0001|TWO_SIDED|95.0|1.8|4.11||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons. This comparison came after the break in statistical hierarchy.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 4 mg/kg + methotrexate treatment groups.||4.11|1.80|<0.0001
73857180|NCT02163967|147259646|OTHER||||||<|0.02||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.Increase in HRV at 2Amp compared to sham.||The null hypothesis is that there is no difference in High frequency HRV after 20 minutes of stimulation or 15 minutes after cessation of stimulation at the low (1mAmp) or high (2mAmp) dose compared to sham stimulation||||<.02
73857181|NCT02163967|147259647|OTHER||||||<|0.001|||||||Chi-squared|||The null hypothesis is that there will be no difference in the number of side effects reported during either dose of stimulation compared to sham stimulation. Statistical differences were examined for light flickering in peripheral vision . Other side effects were reported by too few subjects to be analyzed statistically.||||<.001
73857182|NCT02163967|147259648|OTHER|||||||0.81||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.||||||0.81
73971262|NCT05698875|147483007|OTHER||Mean Difference (Final Values)|33.0||||0.03|TWO_SIDED|95.0|4.0|62.0|||t-test, 2 sided|||HGL vs MGL meals||62|4|0.03
73971263|NCT05698875|147483007|OTHER||Mean Difference (Final Values)|-5.0||||0.63|TWO_SIDED|95.0|-29.0|18.0|||t-test, 2 sided|||HGLP vs MGL meals||18|-29|0.63
73971264|NCT05698875|147483008|OTHER||Mean Difference (Final Values)|22.0||||0.16|TWO_SIDED|95.0|10.0|53.0|||t-test, 2 sided|||Control vs HGL meals||53|10|0.16
73971265|NCT05698875|147483008|OTHER||Mean Difference (Final Values)|21.0||||0.11|TWO_SIDED|95.0|5.0|46.0|||t-test, 2 sided|||Control vs HGLP meals||46|5|0.11
74026056|NCT03351244|147605224|OTHER||Hazard Ratio (HR)|1.006||||0.9938|TWO_SIDED|95.0|0.203|4.989|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||4.989|0.203|0.9938
74026057|NCT03351244|147605224|OTHER||Hazard Ratio (HR)|1.116||||0.893|TWO_SIDED|95.0|0.225|5.531|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||5.531|0.225|0.8930
74026058|NCT03351244|147605224|OTHER||Hazard Ratio (HR)|1.058||||0.936|TWO_SIDED|95.0|0.265|4.233|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||4.233|0.265|0.9360
74026059|NCT03351244|147605226|OTHER||Hazard Ratio (HR)|0.788||||0.6362|TWO_SIDED|95.0|0.293|2.118|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||2.118|0.293|0.6362
74026060|NCT03351244|147605226|OTHER||Hazard Ratio (HR)|0.612||||0.3782|TWO_SIDED|95.0|0.205|1.826|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.826|0.205|0.3782
74026061|NCT03351244|147605226|OTHER||Hazard Ratio (HR)|0.703||||0.4253|TWO_SIDED|95.0|0.296|1.671|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.671|0.296|0.4253
74026062|NCT04899271|147605227|SUPERIORITY|||||||0.807|||||||Chi-squared|||||||0.807
74026063|NCT04899271|147605228|SUPERIORITY|||||||0.746|||||||Chi-squared|||Comparison at month 6||||0.746
74026064|NCT04899271|147605228|SUPERIORITY|||||||0.201|||||||Chi-squared|||Comparison at month 18||||0.201
74026065|NCT04899271|147605229|SUPERIORITY|||||||0.867|||||||Chi-squared|||Comparison at month 6||||0.867
73857183|NCT02163967|147259649|OTHER|||||||0.47||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.||||||0.47
73857184|NCT03077438|147259661|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|7.6|||||TWO_SIDED|95.0|1.1|14.0||||||Serogroup A||14|1.1|
73857185|NCT03077438|147259661|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|47.4|||||TWO_SIDED|95.0|42.2|52.2||||||Serogroup C||52.2|42.2|
73857186|NCT03077438|147259661|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|12.2|||||TWO_SIDED|95.0|7.7|16.7||||||Serogroup Y||16.7|7.7|
73857187|NCT03077438|147259661|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|14.8|||||TWO_SIDED|95.0|8.9|20.5||||||Serogroup W||20.5|8.9|
73857188|NCT03077438|147259662|OTHER||GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.32||||||Serogroup A||1.32|0.91|
73857189|NCT03077438|147259662|OTHER||GMT Ratio|14.0|||||TWO_SIDED|95.0|11.3|17.3||||||Serogroup C||17.3|11.3|
73857190|NCT03077438|147259662|OTHER||GMT Ratio|1.58|||||TWO_SIDED|95.0|1.31|1.9||||||Serogroup Y||1.9|1.31|
73857191|NCT03077438|147259662|OTHER||GMT Ratio|1.43|||||TWO_SIDED|95.0|1.21|1.69||||||Serogroup W||1.69|1.21|
73857192|NCT03077438|147259663|OTHER||GMT Ratio|1.14|||||TWO_SIDED|95.0|0.883|1.47||||||Serogroup A||1.47|0.883|
73857193|NCT03077438|147259663|OTHER||GMT Ratio|17.4|||||TWO_SIDED|95.0|13.4|22.6||||||Serogroup C||22.6|13.4|
73857194|NCT03077438|147259663|OTHER||GMT Ratio|1.38|||||TWO_SIDED|95.0|1.07|1.78||||||Serogroup Y||1.78|1.07|
73857195|NCT03077438|147259663|OTHER||GMT Ratio|1.43|||||TWO_SIDED|95.0|1.12|1.83||||||Serogroup W||1.83|1.12|
73857196|NCT03077438|147259664|OTHER||GMT Ratio|1.06|||||TWO_SIDED|95.0|0.816|1.38||||||Serogroup A||1.38|0.816|
73857197|NCT03077438|147259664|OTHER||GMT Ratio|11.5|||||TWO_SIDED|95.0|8.24|16.0||||||Serogroup C||16|8.24|
73857198|NCT03077438|147259664|OTHER||GMT Ratio|1.84|||||TWO_SIDED|95.0|1.41|2.38||||||Serogroup Y||2.38|1.41|
73857199|NCT03077438|147259664|OTHER||GMT Ratio|1.45|||||TWO_SIDED|95.0|1.16|1.82||||||Serogroup W||1.82|1.16|
73857200|NCT03077438|147259665|OTHER||Percentage Difference|7.6|||||TWO_SIDED|95.0|-1.6|16.7||||||Serogroup A||16.7|-1.6|
73857201|NCT03077438|147259665|OTHER||Percentage Difference|51.1|||||TWO_SIDED|95.0|43.5|57.8||||||Serogroup C||57.8|43.5|
73857202|NCT03077438|147259665|OTHER||Percentage Difference|11.2|||||TWO_SIDED|95.0|4.2|18.1||||||Serogroup Y||18.1|4.2|
73857203|NCT03077438|147259665|OTHER||Percentage Difference|12.5|||||TWO_SIDED|95.0|3.9|20.9||||||Serogroup W||20.9|3.9|
73857204|NCT03077438|147259666|OTHER||Percentage Difference|7.7|||||TWO_SIDED|95.0|-1.3|16.6||||||Serogroup A||16.6|-1.3|
73857205|NCT03077438|147259666|OTHER||Percentage Difference|44.0|||||TWO_SIDED|95.0|36.8|50.6||||||Serogroup C||50.6|36.8|
73857206|NCT03077438|147259666|OTHER||Percentage Difference|13.3|||||TWO_SIDED|95.0|7.6|19.2||||||Serogroup Y||19.2|7.6|
73857207|NCT03077438|147259666|OTHER||Percentage Difference|17.2|||||TWO_SIDED|95.0|9.4|24.7||||||Serogroup W||24.7|9.4|
73857208|NCT04392141|147259675|EQUIVALENCE|equivalence of odds of death between both groups|Odds Ratio (OR)|9.87||||0.0318|TWO_SIDED|95.0|1.16|83.89|||Fisher Exact|||||83.89|1.16|0.0318
73857209|NCT04392141|147259676|EQUIVALENCE|equivalence of SpO2 percentage between admission and discharge phases|Mean Difference (Final Values)|-5.5||||0.0001|TWO_SIDED|95.0|-7.03|-3.96|||t-test, 2 sided|Paired T-test||Statistical comparison of SpO2 (%) between admission and discharge times in standard treatment group||-3.96|-7.03|0.0001
73857210|NCT04392141|147259676|EQUIVALENCE|equivalence of SpO2 percentage between admission and discharge phases|Mean Difference (Final Values)|-2.55||||0.0001|TWO_SIDED|95.0|-3.28|-1.81|||t-test, 2 sided|Paired T-test||Statistical comparison of SpO2 % between admission and discharge times in the Colchicine and Herbal Phenolic Monoterpene Fractions treatment||-1.81|-3.28|0.0001
73857211|NCT04392141|147259677|EQUIVALENCE|equivalence of means of the length of hospitalization between both groups|Mean Difference (Final Values)|2.22||||0.0001|TWO_SIDED|95.0|1.63|2.8|||Wilcoxon (Mann-Whitney)|||||2.80|1.63|0.0001
73857212|NCT04392141|147259678|EQUIVALENCE|equivalence of mean of lymphocytes count between admission and discharge phases|Mean Difference (Final Values)|0.02||||0.8|TWO_SIDED|95.0|-0.136|0.176|||t-test, 2 sided|Paired T-test||Statistical comparison of lymphocytes count between admission and discharge times in standard treatment||0.176|-0.136|0.80
74026066|NCT04899271|147605229|SUPERIORITY|||||||0.769|||||||Chi-squared|||Comparison at month 12||||0.769
74026067|NCT04899271|147605229|SUPERIORITY|||||||0.776|||||||Chi-squared|||Comparison at month 18||||0.776
74026068|NCT04899271|147605230|SUPERIORITY|||||||0.521||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 6 for change from baseline||||0.521
74026069|NCT04899271|147605230|SUPERIORITY|||||||0.959||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.959
74026070|NCT04899271|147605230|SUPERIORITY|||||||0.773||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 18 for change from baseline||||0.773
73857213|NCT04392141|147259678|EQUIVALENCE|equivalence of mean of lymphocytes count between admission and discharge phases|Mean Difference (Final Values)|-0.43||||0.0001|TWO_SIDED|95.0|-0.63|-0.23|||t-test, 2 sided|Paired T-test||Statistical comparison of lymphocytes count between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment||-0.23|-0.63|0.0001
73857214|NCT04392141|147259679|EQUIVALENCE|equivalence of mean of LDH between admission and discharge phases|Mean Difference (Final Values)|-26.06||||0.602|TWO_SIDED|95.0|-124.76|72.64|||t-test, 2 sided|Paired T-test||Statistical comparison of LDH between admission and discharge times in standard treatment||72.64|-124.76|0.602
73857215|NCT04392141|147259679|EQUIVALENCE|equivalence of mean of LDH between admission and discharge phases|Mean Difference (Final Values)|137.33||||0.006|TWO_SIDED|95.0|38.19|236.46|||t-test, 2 sided|Paired T-test||Statistical comparison of LDH between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment||236.46|38.19|0.006
73857216|NCT01425359|147259725|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Angina frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model|||||||0.008
73857217|NCT01425359|147259726|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Sublingual nitroglycerin use frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model|||||||0.003
73857218|NCT03520348|147259739|NON_INFERIORITY|It is considered less than 20% of differences between groups to consider non-inferiority||||||0.285|||||||Wilcoxon (Mann-Whitney)|||||||0.285
73857219|NCT03520348|147259740|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.680
73857220|NCT03520348|147259741|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.839|||||||Wilcoxon (Mann-Whitney)|||||||0.839
73857221|NCT03520348|147259742|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.137|||||||Wilcoxon (Mann-Whitney)|||||||0.137
73857222|NCT03520348|147259744|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.667|||||||Chi-squared, Corrected|||||||0.667
73857223|NCT03520348|147259745|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.561|||||||Chi-squared, Corrected|||||||0.561
73857224|NCT03520348|147259746|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||1|||||||Chi-squared|||||||1.000
73857225|NCT03520348|147259747|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.317|||||||Chi-squared, Corrected|||||||0.317
73857226|NCT03520348|147259748|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.414|||||||Chi-squared, Corrected|||||||0.414
73857227|NCT02292758|147259749|SUPERIORITY||Hazard Ratio (HR)|0.912||||0.7609|TWO_SIDED|95.0|0.431|1.93|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.930|0.431|0.7609
73857228|NCT02292758|147259749|SUPERIORITY||Hazard Ratio (HR)|0.642|||||TWO_SIDED|95.0|0.249|1.656|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)|||1.656|0.249|
73857229|NCT02292758|147259752|SUPERIORITY||Hazard Ratio (HR)|0.471||||0.0446|TWO_SIDED|95.0|0.209|1.062|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.062|0.209|0.0446
73857230|NCT02292758|147259752|SUPERIORITY||Hazard Ratio (HR)|0.406|||||TWO_SIDED|95.0|0.151|1.089|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)|||1.089|0.151|
73857231|NCT02292758|147259754|SUPERIORITY|||||||0.3415|||||||Chi-squared|||||||0.3415
73857232|NCT02292758|147259755|SUPERIORITY|||||||0.1279|||||||Fisher Exact|||||||0.1279
73857233|NCT02292758|147259756|SUPERIORITY|||||||0.447|||||||Log Rank|||||||0.447
73857234|NCT02292758|147259757|SUPERIORITY||Hazard Ratio (HR)|0.755||||0.3738|TWO_SIDED|95.0|0.345|1.655|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.655|0.345|0.3738
73857235|NCT02292758|147259758|SUPERIORITY|||||||0.4283|||||||Wilcoxon (Mann-Whitney)|||Cetuximab comparison||||0.4283
73857236|NCT02292758|147259758|SUPERIORITY|||||||0.5262|||||||Wilcoxon (Mann-Whitney)|||Irinotecan comparison||||0.5262
73857237|NCT03639623|147259815|OTHER|||||||0.053|||||||paired t-test|||||||0.053
73857238|NCT03639623|147259816|OTHER|||||||0.958|||||||paired t-test|||||||0.958
73857239|NCT03639623|147259817|OTHER|||||||0.011|||||||paired t-test|||||||0.011
73857240|NCT03639623|147259818|OTHER|||||||0.454|||||||paired t-test|||||||0.454
73857241|NCT03639623|147259819|OTHER|||||||0.154|||||||paired t-test|||||||0.154
73857242|NCT03639623|147259820|OTHER|||||||0.125|||||||paired t-test|||Outcome Variable: ALT||||0.125
73857243|NCT03639623|147259820|OTHER|||||||0.375|||||||paired t-test|||Outcome Variable: AST||||0.375
73857244|NCT03639623|147259820|OTHER||||||<|0.001|||||||paired t-test|||Outcome Variable: ALP||||<0.001
73857245|NCT03639623|147259821|OTHER|||||||0.054|||||||paired t-test|||||||0.054
73857246|NCT03639623|147259822|OTHER|||||||0.378|||||||paired t-test|||Outcome variable: Total Cholesterol||||0.378
73857247|NCT03639623|147259822|OTHER|||||||0.01|||||||paired t-test|||Outcome Variable: Triglyceride||||0.010
73908371|NCT00734474|147346768|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategies.|LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||"Power was estimated at approximately 89% based on a simulation study using the most likely pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used."||-0.55|-0.87|<0.001
73908372|NCT00734474|147346768|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||"Power was estimated at approximately 89% based on a simulation study using the most likely pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used."||-0.31|-0.63|<0.001
73908373|NCT00734474|147346768|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.55|-0.87|<0.001
73908374|NCT00734474|147346768|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.31|-0.63|<0.001
73908375|NCT00734474|147346770|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26|||<|0.001|TWO_SIDED|95.0|-1.42|-1.09||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-1.09|-1.42|<0.001
73908376|NCT00734474|147346770|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.21|-0.88||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.88|-1.21|<0.001
73908377|NCT00734474|147346770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.64|||<|0.001|TWO_SIDED|95.0|-0.81|-0.48||Comparison at 26 weeks. One-sided raw p-value with no adjustment for multiplicity.|ANCOVA|||||-0.48|-0.81|<0.001
74026071|NCT04899271|147605231|SUPERIORITY|||||||0.691|||||||t-test, 2 sided|Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.||Comparison at month 6 for change from baseline||||0.691
73908378|NCT00734474|147346770|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.50|-0.84|<0.001
73908379|NCT00734474|147346770|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate controlled by applying gatekeeping strategy.|LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.22|-0.56|<0.001
73908380|NCT00734474|147346770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.50|-0.84|<0.001
73908381|NCT00734474|147346770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.22|-0.56|<0.001
73908382|NCT00734474|147346772|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.27|-1.51|||Mixed Models Analysis|Comparison at 26 weeks.||||-1.51|-2.27|<0.001
73908383|NCT00734474|147346772|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.48|||<|0.001|TWO_SIDED|95.0|-1.85|-1.1||Comparison at 26 weeks.|Mixed Models Analysis|||||-1.10|-1.85|<0.001
73908384|NCT00734474|147346772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.012|TWO_SIDED|95.0|-0.86|-0.11||Comparison at 26 weeks.|Mixed Models Analysis|||||-0.11|-0.86|0.012
73908385|NCT00734474|147346772|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.47|||<|0.001|TWO_SIDED|95.0|-1.82|-1.13||Comparison at 52 weeks.|Mixed Models Analysis|||||-1.13|-1.82|<0.001
73908386|NCT00734474|147346772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-1.07|-0.39||Comparison at 52 weeks.|Mixed Models Analysis|||||-0.39|-1.07|<0.001
74026072|NCT04899271|147605231|SUPERIORITY|||||||0.685||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.685
74026073|NCT04899271|147605231|SUPERIORITY|||||||0.64||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||0.640
74026074|NCT04899271|147605232|SUPERIORITY|||||||0.867||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|||Comparison at month 6||||0.867
73964521|NCT04992390|147464630|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.63|||<=|0.001|TWO_SIDED|95.0|-3.72|-1.54||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How distressing were your intrusive memories?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.54|-3.72|<= 0.001
73964522|NCT04992390|147464630|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-3.21|||<=|0.001|TWO_SIDED|95.0|-4.28|-2.15||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did they disrupt your concentration?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-2.15|-4.28|<= 0.001
73964523|NCT04992390|147464630|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.92|||<=|0.001|TWO_SIDED|95.0|-3.9|-1.95||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did they interfere with what you were doing?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.95|-3.90|<= 0.001
73964524|NCT04992390|147464630|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.15|||<=|0.001|TWO_SIDED|95.0|-3.22|-1.08||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your work functioning?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.08|-3.22|<= 0.001
73971266|NCT05698875|147483008|OTHER||Mean Difference (Final Values)|19.0||||0.15|TWO_SIDED|95.0|8.0|45.0|||t-test, 2 sided|||Control vs MGL meals||45|8|0.15
73971267|NCT05698875|147483008|OTHER||Mean Difference (Final Values)|44.0|||<|0.01|TWO_SIDED|95.0|16.0|71.0|||t-test, 2 sided|||HGL vs HGLP meals||71|16|<0.01
73971268|NCT05698875|147483008|OTHER||Mean Difference (Final Values)|-7.0||||0.6|TWO_SIDED|95.0|-36.0|21.0|||t-test, 2 sided|||HGL vs MGL meals||21|-36|0.60
74026075|NCT04899271|147605232|SUPERIORITY|||||||0.769||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared and Fisher's Exact test separated with a /.||Comparison at month 12||||0.769
74026076|NCT04899271|147605232|SUPERIORITY|||||||0.577|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||Comparison at month 18||||0.577
74026077|NCT04899271|147605233|SUPERIORITY|The effect of treatment on the cumulative number of severe hypoglycemic events was evaluated by means of a Cox proportional hazards model. The Andersen-Gill intensity model with model-based variance was utilized.|Hazard Ratio (HR)|1.271||||0.554|TWO_SIDED|95.0|0.573|2.819|||Cox proportional hazards model|Analysis is based on Cox proportional hazards model.||||2.819|0.573|0.554
74026078|NCT04899271|147605235|SUPERIORITY|||||||0.32||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 6 for change from baseline||||0.320
73971269|NCT05698875|147483008|OTHER||Mean Difference (Final Values)|29.0||||0.02|TWO_SIDED|95.0|6.0|51.0|||t-test, 2 sided|||HGLP vs MGL meals||51|6|0.02
74026079|NCT04899271|147605235|SUPERIORITY|||||||0.398||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 12 for change from baseline||||0.398
74026080|NCT04899271|147605235|SUPERIORITY|||||||1||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||1.000
74026081|NCT04899271|147605236|SUPERIORITY|||||||0.892||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 6 for change from baseline||||0.892
73908387|NCT00734474|147346772|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.51|||<|0.001|TWO_SIDED|95.0|-1.93|-1.1||Comparison at 104 weeks.|Mixed Models Analysis|||||-1.10|-1.93|<0.001
74026082|NCT04899271|147605236|SUPERIORITY|||||||0.412||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.412
73857248|NCT03639623|147259822|OTHER|||||||0.264|||||||paired t-test|||Outcome Variable: Non-HDL-C||||0.264
73857249|NCT03639623|147259822|OTHER|||||||0.954|||||||paired t-test|||Outcome Variable: HDL-C||||0.954
73857250|NCT03639623|147259822|OTHER|||||||0.127|||||||paired t-test|||Outcome Variable: HDL-C Subclass 2||||0.127
73857251|NCT03639623|147259822|OTHER|||||||0.029|||||||paired t-test|||Outcome Variable: HDL-C Subclass 3||||0.029
73857252|NCT03639623|147259822|OTHER|||||||0.63|||||||paired t-test|||Outcome variable: LDL-C||||0.630
73857253|NCT03639623|147259822|OTHER|||||||0.01|||||||paired t-test|||Outcome Variable: VLDL-C||||0.010
73857254|NCT03639623|147259822|OTHER|||||||0.16|||||||paired t-test|||Outcome Variable: VLDL concentration||||0.160
73857255|NCT03639623|147259822|OTHER|||||||0.02|||||||paired t-test|||Small dense LDL-C||||0.020
73857256|NCT03639623|147259823|OTHER|||||||0.529|||||||paired t-test|||||||0.529
73857257|NCT03639623|147259824|OTHER|||||||0.403|||||||paired t-test|||Outcome Variable: LDL Size||||0.403
73857258|NCT03639623|147259825|OTHER|||||||0.669|||||||paired t-test|||||||0.669
73857259|NCT03639623|147259826|OTHER|||||||0.021|||||||paired t-test|||Outcome Variable: VLDL chylomicron particles||||0.021
73857260|NCT03639623|147259826|OTHER|||||||0.011|||||||paired t-test|||Outcome Variable: Large VLDL chylomicron particles||||0.011
73857261|NCT03639623|147259826|OTHER|||||||0.06|||||||paired t-test|||Outcome Variable: Medium VLDL particles||||0.060
73857262|NCT03639623|147259826|OTHER|||||||0.324|||||||paired t-test|||Outcome Variable: Small VLDL particles||||0.324
73857263|NCT03639623|147259827|OTHER|||||||0.01|||||||paired t-test|||||||0.010
73857264|NCT03639623|147259828|OTHER|||||||0.249|||||||paired t-test|||||||0.249
73857265|NCT03639623|147259829|OTHER|||||||0.0193|||||||paired t-test|||Time to peak RQ||||0.0193
73857266|NCT03639623|147259830|OTHER|||||||0.96|||||||paired t-test|||Outcome Variable: Physical component score||||0.960
73857267|NCT03639623|147259830|OTHER|||||||0.249|||||||paired t-test|||Outcome Variable: Mental component score||||0.249
73857268|NCT00889603|147259843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.92|||||TWO_SIDED|95.0|1.65|2.2|||||Change from baseline in MMSE at LOCF analyzed using single-sample t-test; a 95% confidence interval (CI) was calculated for mean change at LOCF.|||2.20|1.65|
73857269|NCT00889603|147259844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|0.75|1.08|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 8 from repeated-measures mixed model including terms for baseline MMSE and Week.|||1.08|0.75|
73857270|NCT00889603|147259844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||||TWO_SIDED|95.0|1.32|1.8|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 16 from a repeated-measures mixed model including terms for baseline MMSE and Week.|||1.80|1.32|
73857271|NCT00889603|147259844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.69|2.25|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 24 from a repeated-measures mixed model including terms for baseline MMSE and Week.|||2.25|1.69|
73857272|NCT03650803|147259884|OTHER|Significance (alpha) set to 0.05||||||0.046|||||||t-test, 1 sided|||MRF T1 Changes||||0.046
73857273|NCT03650803|147259884|OTHER|Significance (alpha) set to 0.05||||||0.064|||||||t-test, 2 sided|||MRF T2 Changes||||0.064
73857274|NCT03650803|147259885|OTHER|Significance (alpha) set to 0.05||||||0.82|||||||t-test, 2 sided|||MRF T1 relaxation time||||0.820
73857275|NCT03650803|147259885|OTHER|Significance (alpha) set to 0.05||||||0.605|||||||t-test, 2 sided|||MRF T2 relaxation time||||0.605
73857276|NCT01818258|147259892|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Comparison for number who experienced at least one grade 3 or higher adverse event. Null hypothesis of no difference between cohorts.||||0.40
73857277|NCT01818258|147259893|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||Comparison for number who experienced at least one grade 3 or higher adverse event related to study treatment. Null hypothesis of no difference between cohorts.||||>0.999
73857278|NCT01818258|147259894|SUPERIORITY||Geometric Mean Ratio|0.77||||0.49|TWO_SIDED|95.0|0.4|1.6|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.6|0.4|0.49
73857279|NCT01818258|147259894|SUPERIORITY||Geometric Mean Ratio|0.64||||0.23|TWO_SIDED|95.0|0.3|1.4|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.3|0.23
73857280|NCT01818258|147259894|SUPERIORITY||Geometric Mean Ratio|0.81||||0.63|TWO_SIDED|95.0|0.3|2.0|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.0|0.3|0.63
73857281|NCT01818258|147259895|SUPERIORITY||Geometric Mean Ratio|1.06||||0.89|TWO_SIDED|95.0|0.5|2.3|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of LPV Clearance between cohorts. Null hypothesis of no difference between cohorts.||2.3|0.5|0.89
73857282|NCT01818258|147259895|SUPERIORITY||Geometric Mean Ratio|1.42||||0.37|TWO_SIDED|95.0|0.7|3.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 Comparison of LPV clearance between cohorts. Null hypothesis of no difference between cohorts.||3.1|0.7|0.37
73857283|NCT01818258|147259895|SUPERIORITY||Geometric Mean Ratio|1.23||||0.63|TWO_SIDED|95.0|0.5|2.9|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 Comparison of LPV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.9|0.5|0.63
73908388|NCT00734474|147346772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|||<|0.001|TWO_SIDED|95.0|-1.33|-0.51||Comparison at 104 weeks.|Mixed Models Analysis|||||-0.51|-1.33|<0.001
73908389|NCT00734474|147346773|SUPERIORITY_OR_OTHER||LS Mean Difference|18.51||||0.095|TWO_SIDED|95.0|-3.25|40.28||Comparison at 26 weeks.|Mixed Models Analysis|||||40.28|-3.25|0.095
73908390|NCT00734474|147346773|SUPERIORITY_OR_OTHER||LS Mean Difference|17.08||||0.121|TWO_SIDED|95.0|-4.54|38.69||Comparison at 26 weeks.|Mixed Models Analysis|||||38.69|-4.54|0.121
73964525|NCT04992390|147464630|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.59|||<=|0.001|TWO_SIDED|95.0|-3.67|-1.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your functioning in other areas of your life?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.51|-3.67|<= 0.001
73964526|NCT04992390|147464633|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.8|||<=|0.001|TWO_SIDED|95.0|-1.08|-0.53||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Total Score (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.53|-1.08|<= 0.001
73971270|NCT05698875|147483009|OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|0.8|2.4||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meal excursion vs Control meal at 30 minutes||2.4|0.8|<0.001
73971271|NCT05698875|147483009|OTHER||Mean Difference (Final Values)|0.4||||0.38|TWO_SIDED|95.0|-0.5|1.2|||Linear Mixed Model|||HGLP meal vs Control meal glucose excursion at 30 minutes||1.2|-0.5|0.38
73971272|NCT05698875|147483009|OTHER||Mean Difference (Final Values)|-0.3||||0.47|TWO_SIDED|95.0|-1.1|0.5||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meal excursion vs Control meal at 30 minutes||0.5|-1.1|0.47
73971273|NCT05698875|147483009|OTHER||Mean Difference (Final Values)|1.2||||0.01|TWO_SIDED|95.0|0.5|2.0||a priori threshold for statistical significance p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL meal vs HGLP meal||2.0|0.5|0.01
73908391|NCT00734474|147346773|SUPERIORITY_OR_OTHER||LS Mean Difference|15.41||||0.167|TWO_SIDED|95.0|-6.47|37.29||Comparison at 26 weeks.|Mixed Models Analysis|||||37.29|-6.47|0.167
73908392|NCT00734474|147346773|SUPERIORITY_OR_OTHER||LS Mean Difference|6.38||||0.43|TWO_SIDED|95.0|-9.49|22.26||Comparison at 52 weeks.|Mixed Models Analysis|||||22.26|-9.49|0.430
73908393|NCT00734474|147346773|SUPERIORITY_OR_OTHER||LS Mean Difference|8.77||||0.273|TWO_SIDED|95.0|-6.94|24.47||Comparison at 52 weeks.|Mixed Models Analysis|||||24.47|-6.94|0.273
73908394|NCT00734474|147346773|SUPERIORITY_OR_OTHER||LS Mean Difference|11.07||||0.291|TWO_SIDED|95.0|-9.49|31.64||Comparison at 104 weeks.|Mixed Models Analysis|||||31.64|-9.49|0.291
73908395|NCT00734474|147346773|SUPERIORITY_OR_OTHER||LS Mean Difference|21.28||||0.039|TWO_SIDED|95.0|1.03|41.53||Comparison at 104 weeks.|Mixed Models Analysis|||||41.53|1.03|0.039
73908396|NCT00734474|147346775|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.27|-1.14||Comparison at 26 weeks.|ANCOVA|||||-1.14|-2.27|<0.001
73908397|NCT00734474|147346775|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.16|||<|0.001|TWO_SIDED|95.0|-1.73|-0.6||Comparison at 26 weeks.|ANCOVA|||||-0.60|-1.73|<0.001
73971274|NCT05698875|147483009|OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.1|2.6||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meal vs MGL meals||2.6|1.1|<0.001
73971275|NCT05698875|147483009|OTHER||Mean Difference (Final Values)|0.7||||0.09|TWO_SIDED|95.0|0.1|1.4||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs MGL meals||1.4|0.1|0.09
73908398|NCT00734474|147346775|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.953|TWO_SIDED|95.0|-0.54|0.58||Comparison at 26 weeks.|ANCOVA|||||0.58|-0.54|0.953
73908399|NCT00734474|147346775|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|||<|0.001|TWO_SIDED|95.0|-2.08|-0.92||Comparison at 52 weeks.|ANCOVA|||||-0.92|-2.08|<0.001
73908400|NCT00734474|147346775|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.65|-0.48||Comparison at 52 weeks.|ANCOVA|||||-0.48|-1.65|<0.001
73908401|NCT00734474|147346775|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.14|||<|0.001|TWO_SIDED|95.0|-1.78|-0.49||Comparison at 104 weeks.|ANCOVA|||||-0.49|-1.78|<0.001
73908402|NCT00734474|147346775|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.64||||0.054|TWO_SIDED|95.0|-1.29|0.01||Comparison at 104 weeks.|ANCOVA|||||0.01|-1.29|0.054
73908403|NCT00734474|147346777|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|||<|0.001|TWO_SIDED|95.0|-2.45|-0.93||Comparison at 26 weeks.|Mixed Models Analysis|||||-0.93|-2.45|<0.001
73971276|NCT05698875|147483010|OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|0.7|3.0||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||3.0|0.7|<0.001
73971277|NCT05698875|147483010|OTHER||Mean Difference (Final Values)|-0.1||||0.87|TWO_SIDED|95.0|-1.2|1.0||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||1.0|-1.2|0.87
73971278|NCT05698875|147483010|OTHER||Mean Difference (Final Values)|-0.4||||0.48|TWO_SIDED|95.0|-1.5|0.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||0.7|-1.5|0.48
73971279|NCT05698875|147483010|OTHER||Mean Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|95.0|1.0|3.1||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs HGLP meals||3.1|1.0|<0.001
73971280|NCT05698875|147483010|OTHER||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED|95.0|1.3|3.4||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs MGL meals||3.4|1.3|<0.001
74026083|NCT04899271|147605236|SUPERIORITY|||||||0.371||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||0.371
74026084|NCT03215277|147605241|SUPERIORITY||Mean Posterior Difference|0.23|||||TWO_SIDED|95.0|-0.14|0.6|||Regression, Linear|||Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. The mean posterior difference and 95% credible interval were presented for the BKZ vs CZP comparison.||0.60|-0.14|
74026085|NCT03215277|147605241|SUPERIORITY||PR[Diff > 0%](%)|88.4|||||TWO_SIDED||||||Regression, Linear|||Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. Pr\[Diff\>0%\](%) refers to the probability that the mean change from Baseline in ASDAS in the BKZ group was greater than the mean change from Baseline in ASDAS in the CZP group.||||
73857284|NCT01818258|147259896|SUPERIORITY||Geometric Mean Ratio|0.76||||0.42|TWO_SIDED|95.0|0.4|1.5|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.5|0.4|0.42
74026086|NCT00195351|147605256|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.009||95.0|-13.1|5.1|||t-test, 2 sided|||||5.1|-13.1|0.009
74026087|NCT00195351|147605257|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.4||||0.02||95.0|-14.5|7.8|||t-test, 2 sided|||||7.8|-14.5|0.020
74026088|NCT00195351|147605258|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.9||||0.015||95.0|-13.9|8.1|||Method of Mehrotra and Railkar|||||8.1|-13.9|0.015
74026089|NCT03322657|147605282|SUPERIORITY||Hazard Ratio (HR)|3.8|||<|0.001|TWO_SIDED|95.0|2.2|6.5|||Cox proportional hazard model|||||6.5|2.2|<0.001
74026090|NCT03322657|147605283|SUPERIORITY||Median Difference (Final Values)|6.3||||0.13|TWO_SIDED|95.0|-2.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-2.0|0.13
74026091|NCT03322657|147605284|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.3|TWO_SIDED|95.0|0.43|1.34|||Cox proportional hazard model|||||1.34|0.43|0.30
74026092|NCT03322657|147605285|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.21|TWO_SIDED|95.0|-0.35|1.0|||t-test, 2 sided|||||1.00|-0.35|0.21
74026093|NCT03322657|147605286|SUPERIORITY||Mean Difference (Final Values)|0.82||||0.04|TWO_SIDED|95.0|-0.18|1.81|||t-test, 2 sided|||||1.81|-0.18|0.04
74026094|NCT02513446|147605306|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|176.1|||||TWO_SIDED|90.0|160.5|193.2|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||193.2|160.5|
73857285|NCT01818258|147259896|SUPERIORITY||Geometric Mean Ratio|0.58||||0.11|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.1|0.3|0.11
73857286|NCT01818258|147259896|SUPERIORITY||Geometric Mean Ratio|0.77||||0.44|TWO_SIDED|95.0|0.4|1.5|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.5|0.4|0.44
73857287|NCT01818258|147259897|SUPERIORITY||Geometric Mean Ratio|1.07||||0.84|TWO_SIDED|95.0|0.5|2.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.2|0.5|0.84
73857288|NCT01818258|147259897|SUPERIORITY||Geometric Mean Ratio|1.54||||0.21|TWO_SIDED|95.0|0.8|3.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||3.1|0.8|0.21
73857289|NCT01818258|147259897|SUPERIORITY||Geometric Mean Ratio|1.29||||0.44|TWO_SIDED|95.0|0.7|2.5|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.5|0.7|0.44
73857290|NCT01818258|147259898|SUPERIORITY||Geometric Mean Ratio|0.77||||0.27|TWO_SIDED|95.0|0.5|1.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.2|0.5|0.27
73857291|NCT01818258|147259898|SUPERIORITY||Geometric Mean Ratio|0.6||||0.047|TWO_SIDED|95.0|0.4|1.0|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.0|0.4|0.047
73857292|NCT01818258|147259898|SUPERIORITY||Geometric Mean Ratio|1.09||||0.76|TWO_SIDED|95.0|0.6|1.9|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.9|0.6|0.76
73857293|NCT01818258|147259899|SUPERIORITY||Geometric Mean Ratio|0.0||||0.89|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||0.5|-0.4|0.89
73857294|NCT01818258|147259899|SUPERIORITY||Geometric Mean Ratio|1.4||||0.18|TWO_SIDED|95.0|0.8|2.3|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||2.3|0.8|0.18
73857295|NCT01818258|147259899|SUPERIORITY||Geometric Mean Ratio|0.85||||0.53|TWO_SIDED|95.0|0.5|1.4|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.5|0.53
73857296|NCT01818258|147259900|SUPERIORITY||Geometric Mean Ratio|1.27||||0.39|TWO_SIDED|95.0|0.7|2.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.2|0.7|0.39
74026095|NCT02513446|147605307|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|136.5|||||TWO_SIDED|90.0|109.9|169.4|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||169.4|109.9|
74026096|NCT02513446|147605308|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|174.8|||||TWO_SIDED|90.0|159.1|192.0|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||192.0|159.1|
73857297|NCT01818258|147259900|SUPERIORITY||Geometric Mean Ratio|1.37||||0.43|TWO_SIDED|95.0|0.6|3.0|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||3.0|0.6|0.43
73857298|NCT01818258|147259900|SUPERIORITY||Geometric Mean Ratio|1.52||||0.003|TWO_SIDED|95.0|1.2|2.0|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.0|1.2|0.003
73857299|NCT01818258|147259901|SUPERIORITY||Geometric Mean Ratio|0.6||||0.09|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||1.1|0.3|0.090
73857300|NCT01818258|147259901|SUPERIORITY||Geometric Mean Ratio|0.6||||0.23|TWO_SIDED|95.0|0.3|1.4|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.3|0.23
73857301|NCT01818258|147259901|SUPERIORITY||Geometric Mean Ratio|0.64||||0.0003|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||0.8|0.5|0.0003
73857302|NCT01818258|147259902|SUPERIORITY||Odds Ratio (OR)|0.54||||0.17|TWO_SIDED|95.0|0.22|1.29|||Mixed Models Analysis||Odds Ratio (SAM/non-SAM) for Lopinavir Ctrough \>= 1 ug/mL through 48 weeks|Odds ratio (SAM/non-SAM) of Ctrough \>=1 ug/mL from entry through 48 weeks from repeated measures mixed model, with the null hypothesis that the odds ratio is equal to zero (no difference between cohorts in odds of Ctrough \>=1 ug/mL).||1.29|0.22|0.17
73857303|NCT01818258|147259903|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.003|TWO_SIDED|95.0|-3.9|-0.9|||t-test, 2 sided||Severe Malnutrition Cohort - Normal Nutrition/Mild Malnutrition for Week 1 Free Fraction (%) of LPV|Week 1 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||-0.9|-3.9|0.003
73857304|NCT01818258|147259903|SUPERIORITY||Mean Difference (Final Values)|-3.8||||0.011|TWO_SIDED|95.0|-6.6|-1.1|||t-test, 2 sided||Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 12 Free Fraction (%) of LPV|Week 12 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||-1.1|-6.6|0.011
73857305|NCT01818258|147259903|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.46|TWO_SIDED|95.0|-2.4|4.4|||t-test, 2 sided||Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 24 Free Fraction (%) of LPV|Week 24 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||4.4|-2.4|0.46
73857306|NCT01818258|147259904|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.15|TWO_SIDED|95.0|-0.3|1.7|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 12. Null hypothesis of no difference between cohorts.||1.7|-0.3|0.15
73857307|NCT01818258|147259904|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.2|TWO_SIDED|95.0|-0.4|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 24. Null hypothesis of no difference between cohorts.||1.8|-0.4|0.20
73857308|NCT01818258|147259904|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.13|TWO_SIDED|95.0|-0.2|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 36. Null hypothesis of no difference between cohorts.||1.8|-0.2|0.13
73857309|NCT01818258|147259904|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.089|TWO_SIDED|95.0|-0.1|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 48. Null hypothesis of no difference between cohorts.||1.8|-0.1|0.089
73857310|NCT01818258|147259905|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||Baseline Comparison, with null hypothesis of no difference between cohorts.||||>0.999
73857311|NCT01818258|147259905|SUPERIORITY|||||||0.15|||||||Fisher Exact|||Week 12 Comparison, with null hypothesis of no difference between cohorts.||||0.15
73857312|NCT01818258|147259905|SUPERIORITY|||||||0.065|||||||Fisher Exact|||Week 24 Comparison, with null hypothesis of no difference between cohorts.||||0.065
73857313|NCT01818258|147259905|SUPERIORITY|||||||0.065|||||||Fisher Exact|||Week 48 Comparison, with null hypothesis of no difference between cohorts.||||0.065
73857314|NCT01818258|147259906|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.89|TWO_SIDED|95.0|-3.9|4.4|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 12. Null hypothesis of no difference between cohorts.||4.4|-3.9|0.89
73857315|NCT01818258|147259906|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.31|TWO_SIDED|95.0|-2.5|7.6|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 24. Null hypothesis of no difference between cohorts.||7.6|-2.5|0.31
73857316|NCT01818258|147259906|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.18|TWO_SIDED|95.0|-1.5|7.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 36. Null hypothesis of no difference between cohorts.||7.8|-1.5|0.18
74026097|NCT00843180|147605314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|0.0||0.8|TWO_SIDED|95.0|-5.4|4.2||unadjusted|t-test, 2 sided||this was a feasibility pilot study CI is descriptor of dispersion|comparison between groups by t-test||4.2|-5.4|0.80
74026098|NCT00843180|147605315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|STANDARD_DEVIATION|0.0||0.29|TWO_SIDED|95.0|-6.9|2.1||unadjusted|t-test, 2 sided||CI serves as dispersion measure|||2.1|-6.9|0.29
73857317|NCT01818258|147259906|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.018|TWO_SIDED|95.0|1.1|11.0|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference between cohorts of change in CD4 percent from baseline to week 48. Null hypothesis of no difference between cohorts.||11.0|1.1|0.018
73857318|NCT01818258|147259907|SUPERIORITY||Mean|2.34|||<|0.0001|TWO_SIDED|95.0|1.77|2.91|||t-test, 2 sided|||Null hypothesis: change in WHO weight-for-height Z-score from entry to week 24 equal to 0||2.91|1.77|<0.0001
73857319|NCT01818258|147259907|SUPERIORITY||Mean|2.73|||<|0.0001|TWO_SIDED|95.0|2.09|3.37|||t-test, 2 sided|||Null hypothesis: change in WHO weight-for-height Z-score from entry to week 48 equal to 0||3.37|2.09|<0.0001
73857320|NCT01818258|147259908|SUPERIORITY||Mean|2.63|||<|0.0001|TWO_SIDED|95.0|1.96|3.28|||t-test, 2 sided|||Null hypothesis: change in MUAC from entry to week 24 equal to 0||3.28|1.96|<0.0001
73857321|NCT01818258|147259908|SUPERIORITY||Mean|3.53|||<|0.0001|TWO_SIDED|95.0|2.83|4.24|||t-test, 2 sided|||Null hypothesis: change in MUAC from entry to week 48 equal to 0||4.24|2.83|<0.0001
73857322|NCT01639339|147259917|OTHER||Odds Ratio (OR)|1.55||||0.0311|TWO_SIDED|95.0|1.04|2.32||P-value was calculated using logistic regression model. Test 1 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.32|1.04|0.0311
73857323|NCT01639339|147259918|OTHER||Odds Ratio (OR)|1.74||||0.0167|TWO_SIDED|95.0|1.11|2.74||P-value was calculated using logistic regression model. Test 2 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.74|1.11|0.0167
73857324|NCT01639339|147259919|OTHER||Odds Ratio (OR)|1.59||||0.0245|TWO_SIDED|95.0|1.06|2.38||P-value was calculated using logistic regression model. Test 3 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.38|1.06|0.0245
73857325|NCT01639339|147259920|OTHER||Cox Proportional Hazard|0.51||||0.0014|TWO_SIDED|95.0|0.34|0.77||P-value was calculated using Cox proportional hazards model. Test 4 of 5 in a step-down sequential testing procedure.|Cox proportional hazards model||Treatment comparison between Belimumab 10 mg/kg and placebo using Cox proportional hazards ratio and its corresponding 95% confidence interval has been presented.|||0.77|0.34|0.0014
73857326|NCT01639339|147259921|OTHER|||||||0.0096||||||P-value is rank analysis of covariance model comparing Belimumab and Placebo with covariates for treatment group, induction regimen(CYC vs MMF),race(Black vs Non-black), Baseline uPCR, and eGFR. Test 5 of 5 in step-down sequential testing procedure.|Rank ANCOVA|||||||0.0096
73857327|NCT03022097|147259953|SUPERIORITY||Least squares mean difference|0.092|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.06|0.124||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.124|0.060|<0.001
73857328|NCT03022097|147259954|SUPERIORITY||Least squares mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.053|0.117||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.117|0.053|<0.001
73857329|NCT03022097|147259955|SUPERIORITY||Least squares mean difference|0.134|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.103|0.166||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.166|0.103|<0.001
73857330|NCT03022097|147259956|SUPERIORITY||Least squares mean difference|0.217|STANDARD_ERROR_OF_MEAN|0.017|<|0.001|TWO_SIDED|95.0|0.184|0.25||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.250|0.184|<0.001
73857331|NCT03022097|147259957|SUPERIORITY||Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|0.2|1.3||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|BDI, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||1.3|0.2|0.005
73857332|NCT03022097|147259957|SUPERIORITY||Least squares mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.132|TWO_SIDED|95.0|-0.1|1.0||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|BDI, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||1.0|-0.1|0.132
73857333|NCT03022097|147259958|SUPERIORITY||Least squares mean difference|-4.0|STANDARD_ERROR_OF_MEAN|1.3||0.003|TWO_SIDED|95.0|-6.7|-1.4||Pre-specified hierarchical sequence of testing used to adjust for multiplicity. P-value is nominal.|Mixed Models Analysis|Baseline SGRQ, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||-1.4|-6.7|0.003
73857334|NCT03022097|147259958|SUPERIORITY||Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.3||0.031|TWO_SIDED|95.0|-5.5|-0.3||Pre-specified hierarchical sequence of testing used to adjust for multiplicity. P-value is nominal.|Mixed Models Analysis|Baseline SGRQ, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||-0.3|-5.5|0.031
73857335|NCT01349322|147259962|NON_INFERIORITY|Non-inferiority is defined as a hazard ratio upper limit of 2.12.|Hazard Ratio (HR)|1.32||||0.039|TWO_SIDED|90.0|0.84|2.05|||Regression, Cox||Cause-specific hazard ratio; reference level = Arm 1.|"Assuming Arm 1 5-year IBR of 1.59%, for hypothesized upper bound hazard ratio (HR) of 2.12 (Arm 2 5-year IBR of 3.33%), 46 IBR events provide \>80% power to conclude non-inferiority with one-sided significance level = 0.05. Null hypothesis: HR ≥ 2.12 (inferior). Alternative hypothesis: HR \< 2.12 (non-inferior). See Limitations and Caveats section."||2.05|0.84|0.039
73857336|NCT01349322|147259963|SUPERIORITY|||||||0.96||||||Two-sided significance level = 0.05|Log Rank|||||||0.96
73857337|NCT01349322|147259964|SUPERIORITY|||||||0.14||||||Two-sided significance level = 0.05.|Log Rank|||||||0.14
73857338|NCT01349322|147259965|SUPERIORITY|||||||0.34||||||Two-sided significance level = 0.05|Log Rank|||||||0.34
73908404|NCT00734474|147346777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.133|TWO_SIDED|95.0|-1.34|0.18||Comparison at 26 weeks.|Mixed Models Analysis|||||0.18|-1.34|0.133
74026099|NCT00843180|147605316|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.8|STANDARD_DEVIATION|0.0||0.78|TWO_SIDED|95.0|-31.9|24.3|||t-test, 2 sided||95% CI is dispersion parameter|||24.3|-31.9|0.78
74026100|NCT00843180|147605317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_DEVIATION|0.0||0.7|TWO_SIDED|95.0|-9.5|13.2|||t-test, 2 sided|unadjusted|95%CI is dispersion measure|||13.2|-9.5|0.70
74026101|NCT01476787|147605343|SUPERIORITY|||||||0.128|||||||Cochran-Mantel-Haenszel|||||||0.128
74026102|NCT01476787|147605344|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.406|TWO_SIDED|95.0|0.756|1.12|||Log Rank|||||1.120|0.756|0.406
74026103|NCT01476787|147605346|SUPERIORITY||Hazard Ratio (HR)|1.038|||||TWO_SIDED|95.0|0.854|1.261||||||||1.261|0.854|
74026104|NCT01476787|147605347|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.775|1.395||||||||1.395|0.775|
74026105|NCT01476787|147605348|SUPERIORITY||Hazard Ratio (HR)|0.809|||||TWO_SIDED|95.0|0.651|1.006|||Regression, Cox|||||1.006|0.651|
74026106|NCT01662999|147605370|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.943|||||TWO_SIDED|90.0|0.867|1.026|||Mixed Models Analysis|||The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.026|0.867|
74026107|NCT01662999|147605371|SUPERIORITY_OR_OTHER||Ration of adjusted geometric mean|0.984|||||TWO_SIDED|90.0|0.961|1.008|||Mixed Models Analysis|||Treatment B versus C in AUC(INF). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.008|0.961|
73908405|NCT00734474|147346777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.512|TWO_SIDED|95.0|-1.01|0.5||Comparison at 26 weeks.|Mixed Models Analysis|||||0.50|-1.01|0.512
73908406|NCT00734474|147346777|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.46|||<|0.001|TWO_SIDED|95.0|-2.23|-0.69||Comparison at 52 weeks.|Mixed Models Analysis|||||-0.69|-2.23|<0.001
73908407|NCT00734474|147346777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59||||0.128|TWO_SIDED|95.0|-1.36|0.17||Comparison at 52 weeks.|Mixed Models Analysis|||||0.17|-1.36|0.128
73908408|NCT00734474|147346777|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.005|TWO_SIDED|95.0|-2.3|-0.42||Comparison at 104 weeks.|Mixed Models Analysis|||||-0.42|-2.30|0.005
74026108|NCT01662999|147605373|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.99|||||TWO_SIDED|90.0|0.966|1.014|||Mixed Models Analysis|||Treatment B versus C in AUC(0-T). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.014|0.966|
74026109|NCT01662999|147605375|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.927|||||TWO_SIDED|90.0|0.883|0.972|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||0.972|0.883|
73908409|NCT00734474|147346777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.256|TWO_SIDED|95.0|-1.48|0.4||Comparison at 104 weeks.|Mixed Models Analysis|||||0.40|-1.48|0.256
73908410|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.3|||<|0.001|TWO_SIDED|95.0|6.8|18.8||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||18.8|6.8|<0.001
73908411|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.6|||<|0.001|TWO_SIDED|95.0|5.2|14.3||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||14.3|5.2|<0.001
73908412|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|1.8|4.8||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||4.8|1.8|<0.001
73908413|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|2.7|5.9||Comparison of HbA1c \<7.0% at 52 weeks.|Regression, Logistic|||||5.9|2.7|<0.001
73908414|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.8|3.9||Comparison of HbA1c \<7.0% at 52 weeks.|Regression, Logistic|||||3.9|1.8|<0.001
73908415|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|2.4|5.0||Comparison of HbA1c \<7.0% at 104 weeks.|Regression, Logistic|||||5.0|2.4|<0.001
73908416|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.6|3.3||Comparison of HbA1c \<7.0% at 104 weeks.|Regression, Logistic|||||3.3|1.6|<0.001
73908417|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.5|||<|0.001|TWO_SIDED|95.0|6.5|20.4||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic|||||20.4|6.5|<0.001
73908418|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.001|TWO_SIDED|95.0|2.8|8.8||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic|||||8.8|2.8|<0.001
73908419|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.005|TWO_SIDED|95.0|1.3|4.1||Comparison of HbA1c ≤6.5 at 26 weeks.|Regression, Logistic|||||4.1|1.3|0.005
73908420|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.9|6.8||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic|||||6.8|2.9|<0.001
73908421|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.5|3.5||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic|||||3.5|1.5|<0.001
73908422|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2|||<|0.001|TWO_SIDED|95.0|3.4|7.9||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic|||||7.9|3.4|<0.001
73908423|NCT00734474|147346778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.5|3.7||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic|||||3.7|1.5|<0.001
73908424|NCT00942448|147346814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.2|||<|0.001|||||||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||||< 0.001
74026110|NCT01662999|147605377|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.055|||||TWO_SIDED|90.0|1.004|1.109|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite of saxagliptin). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.109|1.004|
73908425|NCT00942448|147346814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1||||0.001|TWO_SIDED|95.0|18.4|31.7|||ANCOVA|||||31.7|18.4|0.001
73857339|NCT01349322|147259967|NON_INFERIORITY|Null hypothesis (H0) of inferiority: the mean change in cosmetic subscale score in Arm 2 will be at least 0.4 standard deviations worse than in Arm 1. If H0 is rejected, then non-inferiority can be concluded.|Mean Difference (Final Values)|0.026|STANDARD_DEVIATION|0.62|<|0.0001|TWO_SIDED|95.0|-0.08|0.13||One-side significance level = 0.025|t-test, 1 sided|||||0.13|-0.08|<0.0001
73857340|NCT02063867|147259972|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.17
73857341|NCT02063867|147259973|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.16
73857342|NCT02063867|147259974|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.43
73857343|NCT02063867|147259981|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||<0.001
73857344|NCT02063867|147259982|SUPERIORITY|||||||0.0126||||||Remains significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.0126
73857345|NCT02063867|147259983|SUPERIORITY|||||||0.002||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.002
73857346|NCT02063867|147259984|SUPERIORITY|||||||0.0032||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.0032
73857347|NCT04470908|147259993|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.566|||||TWO_SIDED|90.0|0.525|0.61||||||||0.610|0.525|
73857348|NCT04470908|147259994|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.56|||||TWO_SIDED|90.0|0.532|0.589||||||||0.589|0.532|
73857349|NCT04470908|147259995|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.518|||||TWO_SIDED|90.0|0.441|0.608||||||||0.608|0.441|
73857350|NCT04376684|147260002|OTHER||Odds Ratio (OR)|1.32||||0.0456|TWO_SIDED|95.0|0.96|1.82||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.82|0.96|0.0456
73857351|NCT04376684|147260003|OTHER||Odds Ratio (OR)|1.04||||0.8574|TWO_SIDED|95.0|0.67|1.61||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.61|0.67|0.8574
73857352|NCT04376684|147260004|OTHER||Odds Ratio (OR)|0.86||||0.2057|TWO_SIDED|95.0|0.61|1.22||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.22|0.61|0.2057
73857353|NCT04376684|147260005|OTHER||Odds Ratio (OR)|0.79||||0.3061|TWO_SIDED|95.0|0.5|1.24||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.24|0.50|0.3061
73857354|NCT04376684|147260006|OTHER||Odds Ratio (OR)|0.91||||0.6665|TWO_SIDED|95.0|0.59|1.41||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.41|0.59|0.6665
73857355|NCT04376684|147260007|OTHER||Hazard Ratio (HR)|0.88||||0.1942|TWO_SIDED|95.0|0.65|1.18||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.18|0.65|0.1942
73857356|NCT04376684|147260008|OTHER||Hazard Ratio (HR)|0.9||||0.5324|TWO_SIDED|95.0|0.65|1.24||p-value is generated from a two-sided test|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.24|0.65|0.5324
73857357|NCT04376684|147260009|OTHER||Odds Ratio (OR)|1.09||||0.2871|TWO_SIDED|95.0|0.8|1.49||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.49|0.80|0.2871
73857358|NCT04376684|147260010|OTHER||Odds Ratio (OR)|1.16||||0.1754|TWO_SIDED|95.0|0.85|1.58||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.58|0.85|0.1754
74026111|NCT01662999|147605378|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.991|||||TWO_SIDED|90.0|0.96|1.022|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.022|0.960|
74026112|NCT01662999|147605379|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.991|||||TWO_SIDED|90.0|0.961|1.022|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.022|0.961|
74026113|NCT01662999|147605380|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.085|||||TWO_SIDED|90.0|1.058|1.113|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.113|1.058|
74026114|NCT01662999|147605381|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|1.085|||||TWO_SIDED|90.0|1.058|1.113|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.113|1.058|
74026115|NCT01662999|147605382|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.994|||||TWO_SIDED|90.0|0.96|1.03|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.030|0.960|
74026116|NCT01662999|147605383|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.046|||||TWO_SIDED|90.0|1.029|1.064|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the AUC(0-T) of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.064|1.029|
74026117|NCT02234622|147605396|SUPERIORITY||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|1.6||0.002|TWO_SIDED|95.0|-8.2|-1.8|||Mixed Models Analysis|||||-1.8|-8.2|0.002
73908426|NCT00942448|147346827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.2|||<|0.001|TWO_SIDED|95.0|17.6|30.8|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||30.8|17.6|< 0.001
73908427|NCT00942448|147346827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1|||<|0.001|TWO_SIDED|95.0|18.4|31.7|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||31.7|18.4|<0.001
73908428|NCT05027464|147346828|SUPERIORITY||Odds Ratio (OR)|1.249||||0.202|TWO_SIDED|95.0|0.888|1.759||Not adjusted for multiple comparisons; a priori threshold was P \< 0.05.|Regression, Logistic|Patient demographics were fixed effects, and randomization units with clinics nested within randomization units were random effects.|An odds ratio above one indicates favoring the intervention arm over the usual care arm.|Generalized linear mixed model to account for patient demographics and hierarchical levels for clinics nested within VAHCS. Null hypothesis is that both arms perform equivalently in vaccine uptake after a year. Power was based on recruited VAHCSs and at least 1,000 Veterans per clinic. Using two-sided 0.05 type I error rate, 5-20% outcome rate in UC, we have 90% power to detect between a 9.6% and 14.6% difference with a total sample size of 90,000 to 100,000.||1.759|0.888|0.202
73908429|NCT05027464|147346828|SUPERIORITY||Odds Ratio (OR)|1.228||||0.247|TWO_SIDED|95.0|0.867|1.738|||Regression, Logistic|||Sensitivity analysis, same null hypothesis and model as primary analysis but different pool of patients: Not constrained to Veterans with at least one primary care visit||1.738|0.867|0.247
73908430|NCT05027464|147346828|SUPERIORITY||Odds Ratio (OR)|1.263||||0.455|TWO_SIDED|95.0|0.684|2.334|||Regression, Logistic|||Sensitivity analysis; same model and null hypothesis but reassigning small clinics to their parent VAHCS facility, small meaning \< 100 participants. This data set uses the primary analysis data set with the primary visit constraint.||2.334|0.684|0.455
73971281|NCT05698875|147483010|OTHER||Mean Difference (Final Values)|-0.34||||0.53|TWO_SIDED|95.0|-1.4|0.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||0.7|-1.4|0.53
73971282|NCT05698875|147483011|OTHER||Mean Difference (Final Values)|1.3||||0.06|TWO_SIDED|95.0|-0.03|2.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||2.7|-0.03|0.06
74026118|NCT02234622|147605397|SUPERIORITY||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.2||0.005|TWO_SIDED|95.0|-10.3|-1.8|||Mixed Models Analysis|||||-1.8|-10.3|0.005
74026119|NCT02234622|147605398|SUPERIORITY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|2.6||0.042|TWO_SIDED|95.0|-11.9|-1.6|||Mixed Models Analysis|||||-1.6|-11.9|0.042
73908431|NCT05027464|147346828|SUPERIORITY||Odds Ratio (OR)|1.26||||0.364|TWO_SIDED|95.0|0.765|2.075|||Regression, Logistic|||Sensitivity Analysis: same model and null hypothesis as primary outcome but the source of vaccination records omits Medicare claims data. The primary data source had included Medicare claims data on vaccination records as a supplement to the VA data.||2.075|0.765|0.364
73971283|NCT05698875|147483011|OTHER||Mean Difference (Final Values)|-1.1||||0.13|TWO_SIDED|95.0|-2.5|0.3||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.3|-2.5|0.13
74085209|NCT00108082|147724026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.7651||95.0|-1.83|2.49|||ANCOVA|||The null hypotheses (tested hierarchically) were that the effect of carvedilol CR + lisinopril on LV mass regression was no different than the effect of atenolol + lisinopril, and that the effect of carvedilol CR + lisinopril was no different than the effect of lisinopril + lisinopril. The primary analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for treatment, stratification by hypertension class, region, and baseline value, at a 0.05 level of significance.||2.49|-1.83|0.7651
74085210|NCT00108082|147724026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.1711||95.0|-0.7|3.9|||ANCOVA|||||3.90|-0.70|0.1711
73908432|NCT05027464|147346828|SUPERIORITY||Odds Ratio (OR)|1.268||||0.168|TWO_SIDED|95.0|0.904|1.778|||Regression, Logistic|||"Sensitivity Analysis: same model and null hypothesis as primary analysis model but the source of data is supplemented by state level registries, named IZ Gateway, which was deployed summer of 2023 where Veteran records of vaccination could be updated at the VA from external vaccination facilities if the Veteran entered the VA in the same state as that vaccination facility. The primary analysis data contains Medicare claims data in this analysis, too."||1.778|0.904|0.168
73908433|NCT05027464|147346829|SUPERIORITY||Odds Ratio (OR)|0.993||||0.976|TWO_SIDED|95.0|0.643|1.535||P \< 0.05 and no multiple comparison adjustment|Regression, Logistic|We adjusted for patient demographics as fixed effects and randomization units and associated clinics as a three-level random effect.|An odds ratio above one indicates favoring the intervention arm over the usual care arm.|Power calculation is similar to the calculation for the primary outcome. Null hypothesis is described in the outcome comparison related to this statistical analysis plan.||1.535|0.643|.976
73908434|NCT05027464|147346829|SUPERIORITY||Odds Ratio (OR)|0.978||||0.893|TWO_SIDED|95.0|0.702|1.361|||Regression, Logistic|GLMM||Sensitivity analysis, same null hypothesis and model as primary analysis but different pool of patients: Not constrained to Veterans with at least one primary care visit||1.361|0.702|0.893
73908435|NCT05027464|147346829|SUPERIORITY||Odds Ratio (OR)|0.961||||0.863|TWO_SIDED|95.0|0.613|1.507|||Regression, Logistic|GLMM||Sensitivity Analysis: same model and null hypothesis as primary outcome but the source of vaccination records omits Medicare claims data. The primary data source had included Medicare claims data on vaccination records as a supplement to the VA data.||1.507|0.613|0.863
73908436|NCT05027464|147346829|SUPERIORITY||Odds Ratio (OR)|1.011||||0.963|TWO_SIDED|95.0|0.636|1.607|||Regression, Logistic|GLMM||"Sensitivity Analysis: same model and null hypothesis as primary analysis model but the source of data is supplemented by state level registries, named IZ Gateway, which was deployed summer of 2023 where Veteran records of vaccination could be updated at the VA from external vaccination facilities if the Veteran entered the VA in the same state as that vaccination facility. The primary analysis data contains Medicare claims data in this analysis, too."||1.607|0.636|0.963
73964527|NCT04992390|147464633|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.95|||<=|0.001|TWO_SIDED|95.0|-1.27|-0.62||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Intrusion Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.62|-1.27|<= 0.001
73964528|NCT04992390|147464633|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.75|||<=|0.001|TWO_SIDED|95.0|-1.09|-0.42||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Avoidance Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.42|-1.09|<= 0.001
73964529|NCT04992390|147464633|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.7|||<=|0.001|TWO_SIDED|95.0|-0.97|-0.44||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Hyperarousal Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.44|-0.97|<= 0.001
73971284|NCT05698875|147483011|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-1.5|1.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.5|0.82
73971285|NCT05698875|147483011|OTHER||Mean Difference (Final Values)|2.4|||<|0.01|TWO_SIDED|95.0|1.1|3.7||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs MGL meals||3.7|1.1|<0.01
73971286|NCT05698875|147483011|OTHER||Mean Difference (Final Values)|1.5||||0.08|TWO_SIDED|95.0|0.2|2.9||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs MGL meals||2.9|0.2|0.08
74085211|NCT00955552|147724044|NON_INFERIORITY|Non-inferiority test of Ártico vs Cosamin DS® regarding the decrease of pain scale (VAS) in the PP population (N = 86).|||||<|0.05||||||For numeric variables Test -t student or ANOVA will be used. It will be considered statistically significant P-value less than 0,05.|t-test, 1 sided|||||||<0.05
73908437|NCT05027464|147346830|SUPERIORITY||Odds Ratio (OR)|1.191||||0.395|TWO_SIDED|95.0|0.796|1.781||Threshold: P \< 0.05; not adjusted for multiple comparisons|Regression, Logistic|Generalized linear mixed modeling adjusted for baseline covariates and hierarchical levels for randomization units and clinics within them.|Odds ratio in favor of intervention arm (MI) has values higher than 1.|No power calculation for this exploratory outcome. Null hypothesis is that both arms will have equal uptake rates of the COVID-19 Booster vaccination during the study period.||1.781|0.796|0.395
73908438|NCT05027464|147346831|SUPERIORITY||Odds Ratio (OR)|1.128||||0.119|TWO_SIDED|95.0|0.97|1.311||P-value was not adjusted for multiple comparisons and the p-value threshold was \< 0.05.|Regression, Logistic|Generalized linear mixed model adjusting for baseline covariates and flu vaccine in prior year, with hierarchical random effects for ran. unit/site|Odds ratio in favor of novel intervention arm has values higher than 1|Null hypothesis is that both study arms will have equal rates of flu vaccination uptake during the study period. No power calculation since this outcome is exploratory.||1.311|0.97|0.119
73908439|NCT02651467|147346862|SUPERIORITY_OR_OTHER||Difference of Least Square mean|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.181|-0.584||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the Placebo Control, Dunnett's multiplicity adjustment is applied.||-0.584|-1.181|<0.0001
73908440|NCT02651467|147346862|SUPERIORITY_OR_OTHER||Diference of Least Square mean|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.333|-0.738||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the control, Dunnett's multiplicity adjustment is applied.||-0.738|-1.333|<0.0001
73908441|NCT02651467|147346863|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.15||||0.2478||95.0|-0.107|0.413||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.413|-0.107|0.2478
73908442|NCT02024529|147346867|SUPERIORITY|||||||0.97||||||Adjusted for baseline WOMAC score|ANCOVA|||||||0.97
73908443|NCT02024529|147346868|SUPERIORITY|||||||0.75||||||Adjusted for baseline WOMAC score|ANCOVA|||||||0.75
73908444|NCT02024529|147346869|SUPERIORITY|||||||0.18|||||||ANCOVA|Adjusted for baseline WOMAC Score.||||||0.18
73971287|NCT05698875|147483011|OTHER||Mean Difference (Final Values)|0.9||||0.21|TWO_SIDED|95.0|-0.5|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.2|-0.5|0.21
73971288|NCT05698875|147483012|OTHER||Mean Difference (Final Values)|0.8||||0.31|TWO_SIDED|95.0|-0.7|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||2.2|-0.7|0.31
73908445|NCT02024529|147346870|SUPERIORITY|||||||0.81|||||||ANCOVA|Adjusted for baseline WOMAC Score.||||||0.81
73908446|NCT01890746|147346882|OTHER|Bioequivalence|Ratio of geometric means (%)|114.9|||||TWO_SIDED|90.0|99.5|132.7||||||||132.7|99.5|
73908447|NCT01890746|147346883|OTHER|Bioequivalence|Ratio of geometric means (%)|105.2|||||TWO_SIDED|90.0|97.1|114.0||||||||114.0|97.1|
73908448|NCT01890746|147346884|OTHER|Bioequivalence|Ratio of geometric means (%)|92.0|||||TWO_SIDED|90.0|76.8|110.2||||||||110.2|76.8|
73908449|NCT01890746|147346885|OTHER|Bioequivalence|Ratio of geometric means (%)|101.8|||||TWO_SIDED|90.0|92.9|111.7||||||||111.7|92.9|
73908450|NCT01890746|147346886|OTHER|Bioequivalence|Ratio of geometric means (%)|121.0|||||TWO_SIDED|90.0|102.5|142.8||||||||142.8|102.5|
73908451|NCT01890746|147346887|OTHER|Bioequivalence|Ratio of geometric means (%)|106.5|||||TWO_SIDED|90.0|95.0|119.4||||||||119.4|95.0|
73908452|NCT01890746|147346888|OTHER|Bioequivalence|Ratio of geometric means (%)|91.7|||||TWO_SIDED|90.0|76.5|110.0||||||||110.0|76.5|
73908453|NCT01890746|147346889|OTHER|Bioequivalence|Ratio of geometric means (%)|101.4|||||TWO_SIDED|90.0|92.4|111.2||||||||111.2|92.4|
73908454|NCT01890746|147346890|OTHER|Bioequivalence|Ratio of geometric means (%)|120.0|||||TWO_SIDED|90.0|100.7|142.6||||||||142.6|100.7|
73908455|NCT01890746|147346891|OTHER|Bioequivalence|Ratio of geometric means (%)|105.2|||||TWO_SIDED|90.0|93.6|118.3||||||||118.3|93.6|
73908456|NCT01890746|147346892|OTHER|Bioequivalence|Ratio of geometric means (%)|80.4|||||TWO_SIDED|90.0|57.2|113.0||||||||113.0|57.2|
73908457|NCT01890746|147346893|OTHER|Bioequivalence|Ratio of geometric means (%)|106.3|||||TWO_SIDED|90.0|87.6|129.0||||||||129.0|87.6|
73908458|NCT01890746|147346894|OTHER|Bioequivalence|Ratio of geometric means (%)|127.1|||||TWO_SIDED|90.0|84.2|191.9||||||||191.9|84.2|
73908459|NCT01890746|147346895|OTHER|Bioequivalence|Ratio of geometric means (%)|110.5|||||TWO_SIDED|90.0|83.9|145.7||||||||145.7|83.9|
73908460|NCT01890746|147346896|OTHER|Bioequivalence|Ratio of geometric means (%)|286.4|||||TWO_SIDED|90.0|90.1|910.7||||||||910.7|90.1|
73908461|NCT01890746|147346897|OTHER|Bioequivalence|Ratio of geometric means (%)|202.3|||||TWO_SIDED|90.0|131.3|311.8||||||||311.8|131.3|
73908462|NCT01890746|147346899|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.7461|TWO_SIDED|95.0|0.28|2.48|||Log Rank|||||2.48|0.28|0.7461
73971289|NCT05698875|147483012|OTHER||Mean Difference (Final Values)|-1.5||||0.05|TWO_SIDED|95.0|-3.0|-0.1||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||-0.1|-3.0|0.05
73971290|NCT05698875|147483012|OTHER||Mean Difference (Final Values)|0.03||||0.97|TWO_SIDED|95.0|-1.5|1.5||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.5|-1.5|0.97
73971291|NCT05698875|147483012|OTHER||Mean Difference (Final Values)|2.3|||<|0.01|TWO_SIDED|95.0|1.0|3.6||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||3.6|1.0|<0.01
73971292|NCT05698875|147483012|OTHER||Mean Difference (Final Values)|0.8||||0.27|TWO_SIDED|95.0|0.6|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs MGL meals||2.2|0.6|0.27
73971293|NCT05698875|147483012|OTHER||Mean Difference (Final Values)|1.5||||0.12|TWO_SIDED|95.0|0.1|3.0||a priori threshold for statistical significance \<0.05 Adjusted with p value|Linear Mixed Model|||MGL meals vs HGLP meals||3.0|0.1|0.12
73971294|NCT05698875|147483013|OTHER||Mean Difference (Final Values)|-0.2||||0.83|TWO_SIDED|95.0|-1.5|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs control meals||1.2|-1.5|0.83
74026120|NCT02234622|147605399|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.4||0.482|TWO_SIDED|95.0|-4.2|1.1|||Mixed Models Analysis|||||1.1|-4.2|0.482
74026121|NCT02234622|147605400|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.7||0.635|TWO_SIDED|95.0|-4.7|1.9|||Mixed Models Analysis|||||1.9|-4.7|0.635
74026122|NCT02234622|147605401|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.8||0.367|TWO_SIDED|95.0|-6.0|1.1|||Mixed Models Analysis|||||1.1|-6.0|0.367
73857359|NCT04376684|147260011|OTHER||Odds Ratio (OR)|1.29||||0.0616|TWO_SIDED|95.0|0.93|1.79||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.79|0.93|0.0616
73857360|NCT04376684|147260012|OTHER||Odds Ratio (OR)|1.17||||0.183|TWO_SIDED|95.0|0.84|1.63||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.63|0.84|0.1830
73857361|NCT04376684|147260013|OTHER||Odds Ratio (OR)|1.51||||0.0831|TWO_SIDED|95.0|0.95|2.39||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.39|0.95|0.0831
73857362|NCT04376684|147260014|OTHER||Odds Ratio (OR)|1.29||||0.2557|TWO_SIDED|95.0|0.83|2.0||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.00|0.83|0.2557
73908463|NCT01890746|147346900|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.6175|TWO_SIDED|95.0|0.74|1.63|||Log Rank|||||1.63|0.74|0.6175
73908464|NCT01890746|147346901|SUPERIORITY||Odds Ratio (OR)|0.5281||||0.3224|TWO_SIDED|95.0|0.1084|2.2086|||Cochran-Mantel-Haenszel|||||2.2086|0.1084|0.3224
73908465|NCT01890746|147346903|SUPERIORITY|||||||0.6942|||||||Wilcoxon rank-sum test|||||||0.6942
73908466|NCT01890746|147346904|SUPERIORITY||Odds Ratio (OR)|1.1151||||0.7397|TWO_SIDED|95.0|0.5585|2.229|||Cochran-Mantel-Haenszel|||||2.2290|0.5585|0.7397
73908467|NCT01890746|147346905|SUPERIORITY||Hazard Ratio (HR)|2.46||||0.0781|TWO_SIDED|95.0|0.95|6.38|||Log Rank|||||6.38|0.95|0.0781
73908468|NCT01890746|147346909|SUPERIORITY||Odds Ratio (OR)|0.8749||||0.7122|TWO_SIDED|95.0|0.4023|1.8943|||Cochran-Mantel-Haenszel|||||1.8943|0.4023|0.7122
73908469|NCT01890746|147346910|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.0688|TWO_SIDED|95.0|0.96|2.47|||Log Rank|||||2.47|0.96|0.0688
73908470|NCT02642029|147346912|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on IDT accuracy.|Beta coefficient for timexiTBS interact|-0.099|STANDARD_ERROR_OF_MEAN|0.051||0.51|TWO_SIDED|95.0|-0.1989|0.0002||Significance threshold of p \< 0.05, two-sided.|Mixed Models Analysis|Model included time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS).||Conducted a mixed effects analysis, with IDT accuracy as the dependent variable and time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) as the independent variables. P-value here is for the iTBS (vs. sham) x time interaction.||.0002|-.1989|0.51
73908471|NCT02642029|147346912|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on IDT accuracy.|Beta coefficient for timexcTBS interact|-0.0757|STANDARD_ERROR_OF_MEAN|0.052||0.143|TWO_SIDED|95.0|-0.177|0.0256||Significance threshold of p \< 0.05, two-sided.|Mixed Models Analysis|Model included time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS).||Conducted a mixed effects analysis, with IDT accuracy as the dependent variable and time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) as the independent variables. P-value here is for the cTBS (vs. sham) x time interaction.||.0256|-.1770|0.143
73908472|NCT02642029|147346913|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on N-back accuracy.|Beta coefficient for timexiTBS interact|-0.0446||||0.626|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with binomial (logit) distribution.~N-back accuracy was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the iTBS (vs. sham) x time interaction."||||.626
73908473|NCT02642029|147346913|EQUIVALENCE|Tested the null hypothesis of no difference between cTBS and sham TBS on N-back accuracy.|Beta coefficient for timexcTBS interact|-0.0903||||0.322|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with binomial (logit) distribution.~N-back accuracy was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the cTBS (vs. sham) x time interaction."||||0.322
73908474|NCT02642029|147346914|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on N-back accuracy.|Beta coefficient for timexiTBS interact|-9.797||||0.1118|TWO_SIDED|||||Significance threshold of p \< 0.05, two-sided|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with gamma distribution.~N-back reaction time (RT) was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the iTBS (vs. sham) x time interaction."||||0.1118
73908475|NCT02642029|147346914|EQUIVALENCE|Tested the null hypothesis of no difference between cTBS and sham TBS on N-back accuracy.|Beta coefficient for timexcTBS interact|-47.764||||9e-08|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with gamma distribution.~N-back reaction time (RT) was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the cTBS (vs. sham) x time interaction."||||0.00000009
73964530|NCT04992390|147464634|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.29|||<=|0.001|TWO_SIDED|95.0|-3.52|-1.07||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for PTSD Checklist for DSM-5 (PCL-5) 4-item version (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.07|-3.52|<= 0.001
74026123|NCT02234622|147605402|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.668|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||||1.0|-0.5|0.668
74026124|NCT04090164|147605403|OTHER||Odds Ratio (OR)|2.406||||0.0027|TWO_SIDED|95.0|1.341|4.316|||Fisher Exact|||Fisher exact test was used for testing of association of Breast Cancer diagnosis with anti-HCV test status.||4.316|1.341|0.0027
74026125|NCT04090164|147605403|OTHER||Odds Ratio (OR)|7.032||||0.0034|TWO_SIDED|95.0|1.582|31.25|||Fisher Exact|||Fisher exact test was used to test the association of Breast Cancer diagnosis with anti-HCV test result in women younger than 45 years.||31.25|1.582|0.0034
74085212|NCT00412737|147724074|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.283||||0.772|TWO_SIDED|95.0|-2.3|4.1|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|The null hypothesis tested was that there was no difference between the proportions of participants who met the primary endpoint in the two treatment groups.||4.1|-2.3|0.772
73964531|NCT04992390|147464635|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|5.38|||<=|0.001|TWO_SIDED|95.0|2.56|8.2||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Sleep Condition Indicator (SCI) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|8.20|2.56|<= 0.001
74026126|NCT01200433|147605405|NON_INFERIORITY_OR_EQUIVALENCE|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.94||||0.011|TWO_SIDED|90.0|0.84|1.05|||t-test, 1 sided||Dexmedetomidine vs. propofol|||1.05|0.84|0.011
74085213|NCT00412737|147724075|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.37||||0.534|TWO_SIDED|95.0|-2.1|4.5|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|||4.5|-2.1|0.534
74085214|NCT00412737|147724076|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.431||||0.381|TWO_SIDED|95.0|-1.7|4.6|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|||4.6|-1.7|0.381
74085215|NCT00412737|147724077|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.713|||||TWO_SIDED|95.0|-0.6|5.2|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.2|-0.6|
73857363|NCT04376684|147260015|OTHER||Odds Ratio (OR)|1.04||||0.856|TWO_SIDED|95.0|0.67|1.61||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.61|0.67|0.8560
73857364|NCT04376684|147260016|OTHER||Odds Ratio (OR)|1.07||||0.7533|TWO_SIDED|95.0|0.69|1.66||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.66|0.69|0.7533
73857365|NCT04376684|147260017|OTHER||Hazard Ratio (HR)|1.12||||0.0959|TWO_SIDED|95.0|0.95|1.32||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.32|0.95|0.0959
74085216|NCT00412737|147724078|SUPERIORITY_OR_OTHER||Slope|0.858|||||TWO_SIDED|95.0|0.1|5.7|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.7|0.1|
73857366|NCT04376684|147260018|OTHER||Hazard Ratio (HR)|1.12||||0.4421|TWO_SIDED|95.0|0.84|1.5||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.50|0.84|0.4421
73857367|NCT04376684|147260019|OTHER||Odds Ratio (OR)|1.14||||0.2814|TWO_SIDED|95.0|0.73|1.8||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.80|0.73|0.2814
73857368|NCT04376684|147260020|OTHER||Odds Ratio (OR)|1.04||||0.3901|TWO_SIDED|95.0|0.77|1.42||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.42|0.77|0.3901
74085217|NCT00412737|147724079|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.372|||||TWO_SIDED|95.0|-1.9|4.6|||||Relative Risk Reduction = (1.0 - Relative Risk).|||4.6|-1.9|
74085218|NCT00412737|147724080|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.502|||||TWO_SIDED|95.0|-1.4|5.1|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.1|-1.4|
73964532|NCT04992390|147464636|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.93|||<=|0.05|TWO_SIDED|95.0|-1.68|-0.17||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Generalised Anxiety Disorder 2-item scale (GAD-2) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.17|-1.68|<=0.05
73971295|NCT05698875|147483013|OTHER||Mean Difference (Final Values)|-1.5||||0.09|TWO_SIDED|95.0|-2.9|-0.2||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGLP meals vs control meals||-0.2|-2.9|0.09
73971296|NCT05698875|147483013|OTHER||Mean Difference (Final Values)|-0.2||||0.78|TWO_SIDED|95.0|-1.6|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.6|0.78
73857369|NCT04376684|147260021|OTHER||Odds Ratio (OR)|1.01||||0.4763|TWO_SIDED|95.0|0.75|1.36||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.36|0.75|0.4763
73857370|NCT04376684|147260022|OTHER||Odds Ratio (OR)|1.14||||0.1973|TWO_SIDED|95.0|0.84|1.56||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.56|0.84|0.1973
73857371|NCT04376684|147260023|OTHER||Odds Ratio (OR)|1.21||||0.1173|TWO_SIDED|95.0|0.88|1.67||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.67|0.88|0.1173
73857372|NCT04376684|147260024|OTHER||Odds Ratio (OR)|3.98||||0.0037|TWO_SIDED|95.0|1.57|10.13||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||10.13|1.57|0.0037
73857373|NCT04376684|147260025|OTHER||Odds Ratio (OR)|1.26||||0.3581|TWO_SIDED|95.0|0.77|2.06||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.06|0.77|0.3581
73857374|NCT04376684|147260026|OTHER||Odds Ratio (OR)|0.99||||0.9621|TWO_SIDED|95.0|0.63|1.54||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.54|0.63|0.9621
73857375|NCT04376684|147260027|OTHER||Odds Ratio (OR)|0.83||||0.4167|TWO_SIDED|95.0|0.54|1.29||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.29|0.54|0.4167
73857376|NCT04376684|147260028|OTHER||Odds Ratio (OR)|0.81||||0.3408|TWO_SIDED|95.0|0.53|1.25||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.25|0.53|0.3408
73857377|NCT04376684|147260029|OTHER||Hazard Ratio (HR)|1.02||||0.425|TWO_SIDED|95.0|0.85|1.23||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.23|0.85|0.4250
73857378|NCT04376684|147260030|OTHER||Hazard Ratio (HR)|1.13||||0.4774|TWO_SIDED|95.0|0.81|1.59||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.59|0.81|0.4774
73857379|NCT04376684|147260031|OTHER||Odds Ratio (OR)|0.4||||0.0119|TWO_SIDED|95.0|0.18|0.89||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||0.89|0.18|0.0119
73857380|NCT04376684|147260032|OTHER||Hazard Ratio (HR)|1.02||||0.4404|TWO_SIDED|95.0|0.83|1.24||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.24|0.83|0.4404
73857381|NCT04376684|147260033|OTHER||Hazard Ratio (HR)|1.11||||0.6253|TWO_SIDED|95.0|0.72|1.72||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.72|0.72|0.6253
73971297|NCT05698875|147483013|OTHER||Mean Difference (Final Values)|1.4||||0.11|TWO_SIDED|95.0|0.1|2.7||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||2.7|0.1|0.11
73971298|NCT05698875|147483013|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-1.5|1.1||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGL meals||1.1|-1.5|0.82
73908476|NCT02642029|147346915|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.91||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.910
73857382|NCT04376684|147260034|OTHER||Hazard Ratio (HR)|1.11||||0.1078|TWO_SIDED|95.0|0.94|1.3||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.30|0.94|0.1078
73857383|NCT04376684|147260035|OTHER||Hazard Ratio (HR)|1.11||||0.114|TWO_SIDED|95.0|0.94|1.31||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.31|0.94|0.1140
73857384|NCT04376684|147260036|OTHER||Hazard Ratio (HR)|1.06||||0.7084|TWO_SIDED|95.0|0.8|1.4||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.40|0.80|0.7084
73857385|NCT04376684|147260037|OTHER||Hazard Ratio (HR)|1.13||||0.4085|TWO_SIDED|95.0|0.84|1.52||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.52|0.84|0.4085
73857386|NCT02136680|147260073|SUPERIORITY||Regression Coefficient|0.046||||0.4|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.400
73857387|NCT02136680|147260073|SUPERIORITY||Regression Coefficient|0.119||||0.022|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.022
73857388|NCT02136680|147260073|SUPERIORITY||Regression Coefficient|-0.003||||0.347|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.347
73857389|NCT02136680|147260074|SUPERIORITY||Regression Coefficient|-0.003||||0.959|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.959
73857390|NCT02136680|147260074|SUPERIORITY||Regression Coefficient|0.143||||0.021|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.021
73857391|NCT02136680|147260074|SUPERIORITY||Regression Coefficient|0.048||||0.454|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.454
73857392|NCT02136680|147260074|SUPERIORITY||Regression Coefficient|-0.015||||0.774|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from Baseline to First Follow-up||||0.774
73857393|NCT02136680|147260074|SUPERIORITY||Regression Coefficient|0.137||||0.018|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.018
73857394|NCT02136680|147260074|SUPERIORITY||Regression Coefficient|0.051||||0.362|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.362
73857395|NCT02136680|147260075|SUPERIORITY||Regression Coefficient|-0.072||||0.213|TWO_SIDED||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.213
73857396|NCT02136680|147260075|SUPERIORITY||Regression Coefficient|0.037||||0.561|TWO_SIDED||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.561
73857397|NCT02136680|147260075|SUPERIORITY|Change in Palliative Outcomes from First Follow-up to Second Follow-up: Intervention Group vs. Control Group|Regression Coefficient|0.165||||0.008|TWO_SIDED||||||Regression, Linear|||||||0.008
73857398|NCT05151445|147260082|OTHER||95% CI|-3.56||||0.002|TWO_SIDED|95.0|-5.65|-1.46|||McNemar|||Week 4 vs. Baseline||-1.46|-5.65|0.002
73857399|NCT05151445|147260082|OTHER||95% CI|-3.11||||0.004|TWO_SIDED|95.0|-5.07|-1.15|||McNemar|||Week 8 vs. Baseline||-1.15|-5.07|0.004
73857400|NCT05151445|147260082|OTHER||95% CI|-2.53||||0.038|TWO_SIDED|95.0|-4.9|0.16|||McNemar|||Week 12 vs. Baseline||0.16|-4.90|0.038
73857401|NCT05151445|147260083|OTHER||95% CI|9.61||||0.062|TWO_SIDED|95.0|-0.55|19.77|||McNemar|||Week 4 vs. Baseline||19.77|-0.55|0.062
73857402|NCT05151445|147260083|OTHER||95% CI|9.78||||0.098|TWO_SIDED|95.0|-2.01|21.56|||McNemar|||Week 8 vs. Baseline||21.56|-2.01|0.098
73857403|NCT05151445|147260083|OTHER||95% CI|17.06||||0.003|TWO_SIDED|95.0|6.51|27.6|||McNemar|||Week 12 vs. Baseline||27.60|6.51|0.003
73857404|NCT05151445|147260084|OTHER|||||||0.37|||||||McNemar|||Week 4 vs. Baseline||||0.37
73857405|NCT05151445|147260084|OTHER|||||||0.724|||||||McNemar|||Week 8 vs. Baseline||||0.724
73857406|NCT05151445|147260084|OTHER|||||||0.289|||||||McNemar|||Week 12 vs. Baseline||||0.289
73857407|NCT05151445|147260085|OTHER|||||||1|||||||McNemar|||Week 4 vs. Baseline||||1.000
73857408|NCT05151445|147260085|OTHER|||||||1|||||||McNemar|||Week 8 vs. Baseline||||1.000
73857409|NCT05151445|147260085|OTHER|||||||1|||||||McNemar|||Weel 12 vs. Baseline||||1.000
73857410|NCT05151445|147260086|OTHER||95% CI|-1.1||||0.696|TWO_SIDED|95.0|-6.96|4.76|||McNemar|||Week 4 vs. Baseline||4.76|-6.96|0.696
73857411|NCT05151445|147260086|OTHER||95% CI|-1.08||||0.734|TWO_SIDED|95.0|-7.72|5.56|||McNemar|||Week 8 vs. Baseline||5.56|-7.72|0.734
73857412|NCT05151445|147260086|OTHER||95% CI|-4.15||||0.249|TWO_SIDED|95.0|-11.53|3.23|||McNemar|||Week 12 vs. Baseline||3.23|-11.53|0.249
73857413|NCT05151445|147260087|OTHER||95% CI|-0.04||||0.989|TWO_SIDED|95.0|-5.25|5.18|||McNemar|||Week 4 vs. Baseline||5.18|-5.25|0.989
73857414|NCT05151445|147260087|OTHER||95% CI|3.43||||0.263|TWO_SIDED|95.0|-2.83|9.69|||McNemar|||Week 8 vs. Baseline||9.69|-2.83|0.263
73971299|NCT05698875|147483013|OTHER||Mean Difference (Final Values)|1.3||||0.06|TWO_SIDED|95.0|-0.1|2.6||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.6|-0.1|0.06
73971300|NCT05698875|147483014|OTHER||Mean Difference (Final Values)|0.1||||0.85|TWO_SIDED|95.0|-1.1|1.3||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs control meals||1.3|-1.1|0.85
73971301|NCT05698875|147483014|OTHER||Mean Difference (Final Values)|-1.2||||0.06|TWO_SIDED|95.0|-2.4|0.04||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.04|-2.4|0.06
73964533|NCT04992390|147464637|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.52|||>|0.05|TWO_SIDED|95.0|-1.23|0.19||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Patient Health Questionnaire 2-item version (PHQ-2) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.19|-1.23|> .05
73964534|NCT04992390|147464638|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-6.49|||<=|0.001|TWO_SIDED|95.0|-8.48|-4.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Psychological Outcome Profiles (PSYCHLOPS) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-4.51|-8.48|<= 0.001
74026127|NCT01200433|147605406|NON_INFERIORITY_OR_EQUIVALENCE|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.99|||<|0.001|TWO_SIDED|90.0|0.96|1.02|||t-test, 1 sided||Dexmedetomidine vs. propofol|||1.02|0.96|< 0.001
74026128|NCT01200433|147605408|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|99.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
74026129|NCT01200433|147605409|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|1.0||||0.91|TWO_SIDED|99.0|0.86|1.18|||Wilcoxon (Mann-Whitney)|||||1.18|0.86|0.91
74026130|NCT01200433|147605411|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.9||||0.02|TWO_SIDED|99.0|-4.1|0.2|||Wilcoxon (Mann-Whitney)|||||0.2|-4.1|0.02
74026131|NCT01200433|147605412|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||>|0.99|TWO_SIDED|99.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|>0.99
73857415|NCT05151445|147260087|OTHER||Slope|0.44||||0.882|TWO_SIDED|95.0|-5.8|6.68|||McNemar|||Week 12 vs. Baseline||6.68|-5.80|0.882
73857416|NCT05151445|147260088|OTHER||95% CI|-0.62||||0.425|TWO_SIDED|95.0|-2.23|0.98|||McNemar|||Week 4 vs. Baseline||0.98|-2.23|0.425
73857417|NCT05151445|147260088|OTHER||95% CI|-4.98||||0.205|TWO_SIDED|95.0|-9.08|-0.88|||McNemar|||Week 8 vs. Baseline||-0.88|-9.08|0.205
73857418|NCT05151445|147260088|OTHER||95% CI|-4.98||||0.02|TWO_SIDED|95.0|-9.08|-0.8|||McNemar|||Week 12 vs. Baseline||-0.8|-9.08|0.020
73857419|NCT05151445|147260089|OTHER||95% CI|0.429||||0.429|TWO_SIDED|95.0|-4.9|11.01|||McNemar|||Week 4 vs. Baseline||11.01|-4.90|0.429
73857420|NCT05151445|147260089|OTHER||95% CI|-4.39||||0.255|TWO_SIDED|95.0|-12.24|3.46|||McNemar|||Week 8 vs. Baseline||3.46|-12.24|0.255
73857421|NCT05151445|147260089|OTHER||95% CI|-7.0||||0.102|TWO_SIDED|95.0|-15.55|1.55|||McNemar|||Week 12 vs. Baseline||1.55|-15.55|0.102
73857422|NCT05151445|147260090|OTHER||95% CI|-1.94||||0.568|TWO_SIDED|95.0|-8.99|5.1|||McNemar|||Week 4 vs. Baseline||5.10|-8.99|0.568
73857423|NCT05151445|147260090|OTHER||95% CI|-4.11||||0.198|TWO_SIDED|95.0|-10.59|2.37|||McNemar|||Week 8 vs. Baseline||2.37|-10.59|0.198
73857424|NCT05151445|147260090|OTHER||95% CI|-3.76||||0.225|TWO_SIDED|95.0|-10.08|2.55|||McNemar|||Week 12 vs. Baseline||2.55|-10.08|.225
73857425|NCT01457014|147260091|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|p values have undergone Bonferroni adjustment for Central Apnea Index (CAI), Obstructive Apnea Index (OAI) and Hypopnea Index (HI)||||||<0.001
73857426|NCT01457014|147260092|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED|||||p value has undergone Bonferroni adjustment. P-Value applies to Av. 02 saturation|Wilcoxon (Mann-Whitney)|p value has undergone Bonferroni adjustment||||||0.627
73857427|NCT01457014|147260093|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.161
73857428|NCT05463744|147260094|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|0.052|||||TWO_SIDED|95.0|-0.077|0.181|||ANCOVA|||||0.181|-0.077|
73857429|NCT05463744|147260095|SUPERIORITY||LS Mean Difference|0.052||||0.432|TWO_SIDED|95.0|-0.077|0.181|||ANCOVA|||||0.181|-0.077|0.432
73857430|NCT05463744|147260096|SUPERIORITY||LS Mean Difference|-0.31||||0.751|TWO_SIDED|95.0|-2.22|1.6|||ANCOVA|||||1.60|-2.22|0.751
73857431|NCT05463744|147260097|SUPERIORITY||Relative Rate|1.02||||0.9|TWO_SIDED|95.0|0.79|1.31|||Negative binomial model|||||1.31|0.79|0.900
73857432|NCT05463744|147260098|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0682|||TWO_SIDED|95.0|-0.11|0.157|||ANCOVA|||||0.157|-0.110|
73857433|NCT05463744|147260099|SUPERIORITY||LS Mean Difference|-1.22||||0.697|TWO_SIDED|95.0|-7.38|4.93|||ANCOVA|||Week 26||4.93|-7.38|0.697
73857434|NCT05463744|147260099|SUPERIORITY||LS Mean Difference|-4.84||||0.163|TWO_SIDED|95.0|-11.64|1.96|||ANCOVA|||Week 52||1.96|-11.64|0.163
73857435|NCT05463744|147260100|SUPERIORITY||LS Mean Difference|0.02||||0.939|TWO_SIDED|95.0|-0.61|0.66|||Mixed Models Analysis|||Week 23 to Week 26||0.66|-0.61|0.939
73857436|NCT05463744|147260100|SUPERIORITY||LS Mean Difference|0.52||||0.116|TWO_SIDED|95.0|-0.13|1.17|||Mixed Models Analysis|||Week 49 to Week 52||1.17|-0.13|0.116
73857437|NCT05463744|147260101|SUPERIORITY||LS Mean Difference|0.54||||0.61|TWO_SIDED|95.0|-1.54|2.62|||ANCOVA|||||2.62|-1.54|0.610
73908477|NCT02642029|147346915|OTHER|Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|beta coefficient for depressed mood|0.00071||||0.243|TWO_SIDED|95.0|-0.00048|0.0019|||Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, depressed mood). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00190|-0.00048|0.243
73908478|NCT02642029|147346916|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.83||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.830
73908479|NCT02642029|147346916|OTHER||beta coefficient for anxiety|-0.00063||||0.284|TWO_SIDED|95.0|-0.00179|0.00052||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, anxiety). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00052|-0.00179|0.284
73908480|NCT02642029|147346917|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.755||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.755
73908481|NCT02642029|147346917|OTHER||beta coefficient for elated mood|-0.0007||||0.317|TWO_SIDED|95.0|-0.00208|0.00067||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, elated mood). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00067|-0.00208|0.317
73908482|NCT02642029|147346918|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.035||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.035
73908483|NCT02642029|147346918|OTHER||beta coefficient for auditory hallucinat|0.00195||||0.028|TWO_SIDED|95.0|0.00021|0.00369||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, auditory hallucinations). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00369|0.00021|0.028
73857438|NCT05463744|147260102|SUPERIORITY||LS Mean Difference|-8.96||||0.155|TWO_SIDED|95.0|-21.3|3.38|||Mixed Models Analysis|||Week 26||3.38|-21.30|0.155
73857439|NCT05463744|147260102|SUPERIORITY||LS Mean Difference|-6.88||||0.278|TWO_SIDED|95.0|-19.31|5.55|||Mixed Models Analysis|||Week 52||5.55|-19.31|0.278
73857440|NCT05463744|147260103|SUPERIORITY||LS Mean Difference|-3.77|||<|0.001|TWO_SIDED|95.0|-5.52|-2.03|||Mixed Models Analysis|||Week 26||-2.03|-5.52|<0.001
73857441|NCT05463744|147260103|SUPERIORITY||LS Mean Difference|-3.49|||<|0.001|TWO_SIDED|95.0|-5.26|-1.71|||Mixed Models Analysis|||Week 52||-1.71|-5.26|<0.001
73857442|NCT05463744|147260104|SUPERIORITY||LS Mean Difference|-39.28|||<|0.001|TWO_SIDED|95.0|-57.59|-20.98|||Mixed Models Analysis|||Week 26||-20.98|-57.59|<0.001
73908484|NCT02642029|147346919|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.748||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.748
73971302|NCT05698875|147483014|OTHER||Mean Difference (Final Values)|-0.08||||0.9|TWO_SIDED|95.0|-1.3|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.3|0.90
73857443|NCT05463744|147260104|SUPERIORITY||LS Mean Difference|-35.94|||<|0.001|TWO_SIDED|95.0|-54.44|-17.43|||Mixed Models Analysis|||Week 52||-17.43|-54.44|<0.001
73857444|NCT05463744|147260105|SUPERIORITY||LS Mean Difference|3.19|||<|0.001|TWO_SIDED|95.0|1.32|5.06|||Mixed Models Analysis|||Week 26||5.06|1.32|<0.001
73857445|NCT05463744|147260105|SUPERIORITY||LS Mean Difference|2.8||||0.004|TWO_SIDED|95.0|0.91|4.7|||Mixed Models Analysis|||Week 52||4.70|0.91|0.004
73857446|NCT05463744|147260106|SUPERIORITY||Relative Rate|1.21||||0.016|TWO_SIDED|95.0|1.04|1.41|||Negative binomial model|||||1.41|1.04|0.016
73857447|NCT05463744|147260107|SUPERIORITY||LS Mean Difference|0.086||||0.702|TWO_SIDED|95.0|-0.35|0.53|||Mixed Models Analysis|||Week 26||0.53|-0.35|0.702
73857448|NCT05463744|147260107|SUPERIORITY||LS Mean Difference|0.12||||0.609|TWO_SIDED|95.0|-0.33|0.56|||Mixed Models Analysis|||Week 52||0.56|-0.33|0.609
73857449|NCT05463744|147260108|SUPERIORITY||LS Mean Difference|0.03||||0.681|TWO_SIDED|95.0|-0.13|0.19|||ANCOVA|||Week 23 to Week 26||0.19|-0.13|0.681
73857450|NCT05463744|147260108|SUPERIORITY||LS Mean Difference|0.1||||0.182|TWO_SIDED|95.0|-0.05|0.24|||ANCOVA|||Week 49 to Week 52||0.24|-0.05|0.182
73857451|NCT05463744|147260109|SUPERIORITY||LS Mean Difference|0.0||||0.999|TWO_SIDED|95.0|-2.06|2.05|||ANCOVA|||Week 23 to Week 26||2.05|-2.06|0.999
73857452|NCT05463744|147260110|SUPERIORITY||LS Mean Difference|-0.83||||0.468|TWO_SIDED|95.0|-3.06|1.41|||ANCOVA|||||1.41|-3.06|0.468
74085219|NCT00513617|147724089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1254|STANDARD_ERROR_OF_MEAN|0.0705||0.08||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from the Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.080
73857453|NCT05463744|147260111|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
73930949|NCT00280566|147391711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.88||0.9632|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9632
73857454|NCT05463744|147260112|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73857455|NCT05463744|147260113|SUPERIORITY||LS Mean Difference|0.43||||0.27|TWO_SIDED|95.0|-0.33|1.19|||Mixed Models Analysis|||Physical Component Score: Week 26||1.19|-0.33|0.270
73857456|NCT05463744|147260113|SUPERIORITY||LS Mean Difference|0.73||||0.05|TWO_SIDED|95.0|0.0|1.45|||Mixed Models Analysis|||Physical Component Score: Week 52||1.45|0.000|0.050
73857457|NCT05463744|147260113|SUPERIORITY||LS Mean Difference|0.22||||0.71|TWO_SIDED|95.0|-0.94|1.38|||Mixed Models Analysis|||Mental Component Score: Week 26||1.38|-0.94|0.710
73857458|NCT05463744|147260113|SUPERIORITY||LS Mean Difference|0.45||||0.447|TWO_SIDED|95.0|-0.71|1.61|||Mixed Models Analysis|||Mental Component Score: Week 52||1.61|-0.71|0.447
73857459|NCT02825420|147260119|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
73857460|NCT02825420|147260120|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
73857461|NCT02825420|147260121|SUPERIORITY|||||||0.62|||||||Log Rank|||||||0.62
73857462|NCT02825420|147260123|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
73857463|NCT02825420|147260125|SUPERIORITY|||||||0.048|||||||Log Rank|||||||0.048
73971303|NCT05698875|147483014|OTHER||Mean Difference (Final Values)|1.4||||0.05|TWO_SIDED|95.0|0.3|2.5||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||2.5|0.3|0.05
73857464|NCT02825420|147260126|SUPERIORITY|||||||0.51|||||||Log Rank|||||||0.51
73857465|NCT01468207|147260220|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|15.9|||=|0.003|TWO_SIDED|95.0|5.3|26.5||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel|||||26.5|5.3|=0.003
73857466|NCT01468207|147260220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.8|||=|0.048|TWO_SIDED|95.0|0.3|29.3|||Chi-squared|||||29.3|0.3|=0.048
73857467|NCT01468207|147260220|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.1|||=|0.027|TWO_SIDED|95.0|2.2|32.1|||Chi-squared|||||32.1|2.2|=0.027
73857468|NCT01468207|147260221|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|||=|0.961|TWO_SIDED|95.0|-13.4|14.1|||Chi-squared|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||14.1|-13.4|=0.961
73857469|NCT01468207|147260222|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|2.8|||=|0.628|TWO_SIDED|95.0|-8.6|14.2||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||14.2|-8.6|=0.628
73857470|NCT01468207|147260223|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.7|||=|0.124|TWO_SIDED|95.0|-19.7|2.4|||ANCOVA|P-value calculated from ANCOVA with stratum, baseline, and treatment as covariates.||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||2.4|-19.7|=0.124
73857471|NCT01328041|147260230|SUPERIORITY_OR_OTHER||T distribution|-1.432|||<|0.001|TWO_SIDED|95.0|-1.52|-1.343||The P value was derived by the null hypothesis testing of no change from Baseline in HIV-1 RNA at Day 8 at the two-sided 5% significance level using a single sample t-test.|t-test, 2 sided|||||-1.343|-1.520|<0.001
73857472|NCT01328041|147260231|SUPERIORITY_OR_OTHER||percentage of participants|69.0|||||TWO_SIDED|95.0|62.0|76.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 24.|||76|62|
73857473|NCT01328041|147260232|SUPERIORITY_OR_OTHER||percentage of participants|63.0|||||TWO_SIDED|95.0|56.0|70.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 48.|||70|56|
73857474|NCT02688088|147260252|SUPERIORITY||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.965|1.06||||||||1.06|0.965|
73857475|NCT02688088|147260253|SUPERIORITY||Ratio of Geometric LS Means|0.935|||||TWO_SIDED|90.0|0.871|1.0||||||||1.00|0.871|
73857476|NCT02688088|147260254|SUPERIORITY||Ratio of Geometric LS Means|1.05|||||TWO_SIDED|90.0|0.898|1.22||||||||1.22|0.898|
73857477|NCT02688088|147260255|SUPERIORITY||Ratio of Geometric LS Means|0.845|||||TWO_SIDED|90.0|0.76|0.94||||||||0.940|0.760|
73857478|NCT02688088|147260256|SUPERIORITY||Ratio of Geometric LS Means|1.56|||||TWO_SIDED|90.0|1.35|1.81||||||||1.81|1.35|
73857479|NCT02688088|147260257|SUPERIORITY||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.956|1.13||||||||1.13|0.956|
73857480|NCT02688088|147260258|SUPERIORITY||Mean Difference (Final Values)|0.976|||||TWO_SIDED|90.0|0.805|1.18||||||||1.18|0.805|
73857481|NCT02688088|147260259|SUPERIORITY||Ratio of Geometric LS Means|0.867|||||TWO_SIDED|90.0|0.775|0.972||||||||0.972|0.775|
73857482|NCT05275010|147260270|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the AUC0-62 values for pertuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.0|||||TWO_SIDED|90.0|0.93|1.08|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.08|0.93|
73857483|NCT05275010|147260271|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the AUC0-62 values for trastuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.0|||||TWO_SIDED|90.0|0.93|1.09|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.09|0.93|
73908485|NCT02642029|147346919|OTHER||beta coefficient for visual hallucinatio|-0.00039||||0.685|TWO_SIDED|95.0|-0.0023|0.00151||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, visual hallucinations). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00151|-0.00230|0.685
73908486|NCT02642029|147346920|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.02||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.020
73908487|NCT02642029|147346920|OTHER||beta coefficient for paranoid ideation|0.0004||||0.597|TWO_SIDED|95.0|-0.00108|0.00188||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, paranoid ideation). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00188|-0.00108|0.597
73908488|NCT02642029|147346921|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.237||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.237
73908489|NCT02642029|147346921|OTHER||beta coefficient for ideas/del of refere|-0.00142||||0.178|TWO_SIDED|95.0|-0.0035|0.00065||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, ideas/delusions of reference). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00065|-0.00350|0.178
73908490|NCT02642029|147346922|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.33||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.330
73908491|NCT02642029|147346922|OTHER||beta coefficient for delusions of contro|-0.00038||||0.777|TWO_SIDED|95.0|-0.00305|0.00228||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, delusions of control). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00228|-0.00305|0.777
73964535|NCT04992390|147464639|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-9.78|||<=|0.001|TWO_SIDED|95.0|-15.06|-4.5||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-4.50|-15.06|<= 0.001
73971304|NCT05698875|147483014|OTHER||Mean Difference (Final Values)|0.34||||0.55|TWO_SIDED|95.0|-0.8|1.5||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs MGL meals||1.5|-0.8|0.55
73971305|NCT05698875|147483014|OTHER||Mean Difference (Final Values)|1.1||||0.08|TWO_SIDED|95.0|-0.1|2.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.2|-0.1|0.08
73971306|NCT03621371|147483149|OTHER||F-test|9.88|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
74026132|NCT01877655|147605415|SUPERIORITY||Odds Ratio (OR)|1.27||||0.205|TWO_SIDED|95.0|0.87|1.85||P-value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI was based on CMH general association test stratified by donor-recipient relatedness \& donor CMV serostatus.|Analysis of all-cause mortality and adjudicated CMV EOD. Analysis was completed using the Cochran-Mantel-Haenszel (CMH) test at the 1-sided 5% level stratified by use of antithymocyte globulin (ATG) and by receipt of a kidney from a living or deceased donor.||1.85|0.87|0.205
74026133|NCT01877655|147605416|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.748|TWO_SIDED|95.0|0.76|1.22||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of CMV viremia through 1 year posttransplant. CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The 95% CI was based on cumulative incidence function CMV viremia rate at 1 year.||1.22|0.76|0.748
73908492|NCT00676338|147346933|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.62|TWO_SIDED|98.3|-0.26|0.17||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||0.17|-0.26|0.620
73908493|NCT00676338|147346933|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.328|TWO_SIDED|98.3|-0.15|0.35||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||0.35|-0.15|0.328
73908494|NCT00676338|147346933|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|98.3|-0.62|-0.13||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||-0.13|-0.62|<.001
73908495|NCT00676338|147346934|SUPERIORITY_OR_OTHER|||||||0.151|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||0.151
73908496|NCT00676338|147346934|SUPERIORITY_OR_OTHER|||||||0.913|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||0.913
73908497|NCT00676338|147346934|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||<.001
73908498|NCT00676338|147346935|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.155|TWO_SIDED|95.0|-0.66|0.1||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.10|-0.66|0.155
73908499|NCT00676338|147346935|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.22||0.153|TWO_SIDED|95.0|-0.12|0.75||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.75|-0.12|0.153
73908500|NCT00676338|147346935|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.56|-0.68||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.68|-1.56|<.001
73908501|NCT00676338|147346936|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.892|TWO_SIDED|95.0|-0.61|0.53||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.53|-0.61|0.892
73964536|NCT04992390|147464640|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|12.32|||<=|0.01|TWO_SIDED|95.0|4.61|20.04||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for 5-level European Quality of Life 5 Dimension (EQ-5D-5L) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 for EQ-5D-5L subscale comparisons and Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|20.04|4.61|<= 0.01
73908502|NCT00676338|147346936|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.56|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-4.21|-2.9||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-2.90|-4.21|<.001
73908503|NCT00676338|147346936|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.92|-0.63||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.63|-1.92|<.001
73908504|NCT00676338|147346937|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.08||0.873|TWO_SIDED|95.0|-0.18|0.15||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.15|-0.18|0.873
73964537|NCT04992390|147464641|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|0.46|||<=|0.001|TWO_SIDED|95.0|0.2|0.71||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.71|0.20|<= 0.001
73964538|NCT04992390|147464641|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.61|||<=|0.001|TWO_SIDED|95.0|-0.87|-0.34||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.34|-0.87|<= 0.001
73908505|NCT00676338|147346937|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.14||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.14|-0.52|<.001
73908506|NCT00676338|147346937|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.41|-0.03||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.03|-0.41|0.022
73908507|NCT00676338|147346938|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.004|TWO_SIDED|95.0|-0.09|-0.02||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.02|-0.09|0.004
73908508|NCT00676338|147346938|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.19|-0.11||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.11|-0.19|<.001
73908509|NCT00676338|147346938|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.142|TWO_SIDED|95.0|-0.07|0.01||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.01|-0.07|0.142
73908510|NCT00676338|147346939|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.04||0.657|TWO_SIDED|95.0|0.94|1.1||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.10|0.94|0.657
73908511|NCT00676338|147346939|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.16|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|1.06|1.27||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.27|1.06|0.002
73908512|NCT00676338|147346939|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.04|STANDARD_ERROR_OF_MEAN|0.05||0.398|TWO_SIDED|95.0|0.95|1.14||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.14|0.95|0.398
73908513|NCT00676338|147346942|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.09||0.201|TWO_SIDED|95.0|-3.52|0.74||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.74|-3.52|0.201
73908514|NCT00676338|147346942|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.24||0.693|TWO_SIDED|95.0|-1.94|2.93||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||2.93|-1.94|0.693
73908515|NCT00676338|147346942|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.22||0.646|TWO_SIDED|95.0|-1.84|2.96||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||2.96|-1.84|0.646
73908516|NCT00676338|147346943|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.7||0.61|TWO_SIDED|95.0|-1.02|1.73||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||1.73|-1.02|0.610
73908517|NCT00676338|147346943|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.8||0.013|TWO_SIDED|95.0|0.43|3.58||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||3.58|0.43|0.013
73908518|NCT00676338|147346943|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.79||0.946|TWO_SIDED|95.0|-1.6|1.49||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||1.49|-1.60|0.946
73908519|NCT02122458|147346944|SUPERIORITY||Mean Difference (Net)|0.448||||0.05|TWO_SIDED|95.0|-8.66|9.56||Given the preliminary nature of this treatment study and the small number of participants the p-value was not adjusted for multiple comparisons.|Mixed Models Analysis|An Adjusted Rank Transform was applied to the data prior to applying the mixed model analyses.||The null hypothesis evaluated by the HHIA was that self-perceived hearing handicap would not reduce from baseline to 6-months post-fitting.||9.56|-8.66|.05
73908520|NCT02122458|147346945|SUPERIORITY|||||||0.05||||||Given the small sample size and the preliminary nature of this study, the p-value was not adjusted for multiple comparisons.|ANOVA|||||||.05
74026134|NCT01877655|147605417|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.888|TWO_SIDED|95.0|0.8|1.29||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of CMV-specific antiviral therapy (AVT) through 1 year. Time to first adjudicated CMV-specific therapy was defined as time to the start of AVT for CMV viremia. CMV-specific AVT was determined by the adjudication committee. Rate was based on cumulative incidence function estimate at 1 year.||1.29|0.80|0.888
73908521|NCT03161093|147346950|SUPERIORITY||Least Squares Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.18||0.0002|TWO_SIDED|95.0|-1.028|-0.324|||Mixed Models Analysis|||||-0.324|-1.028|0.0002
73908522|NCT03161093|147346951|SUPERIORITY||Least Squares Mean|-0.7|STANDARD_ERROR_OF_MEAN|0.178|<|0.0001|TWO_SIDED|95.0|-1.046|-0.346|||Mixed Models Analysis|||||-0.346|-1.046|<0.0001
73908523|NCT03161093|147346952|SUPERIORITY||Least Squares Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.254||0.7036|TWO_SIDED|95.0|-0.594|0.401|||Mixed Models Analysis|||||0.401|-0.594|0.7036
73908524|NCT03161093|147346953|SUPERIORITY||Least Squares Mean|-0.18|STANDARD_ERROR_OF_MEAN|0.243||0.4605|TWO_SIDED|95.0|-0.657|0.297|||Mixed Models Analysis|||||0.297|-0.657|0.4605
73908525|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.12||||||Serotype 1: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.12|0.74|
73908526|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 3: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.98|0.70|
73908527|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.55|0.91||||||Serotype 4: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.91|0.55|
73908528|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.78|1.18||||||Serotype 5: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.18|0.78|
73908529|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.53|0.85||||||Serotype 6A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.85|0.53|
73908530|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.08||||||Serotype 6B: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.08|0.64|
73908531|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.83|1.14||||||Serotype 7F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.14|0.83|
73908532|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.69|1.0||||||Serotype 9V: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.0|0.69|
73908533|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.62|0.92||||||Serotype 14: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.92|0.62|
73908534|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.06||||||Serotype 18C: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.06|0.64|
73908535|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.72|1.04||||||Serotype 19A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.04|0.72|
73908536|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.71|1.14||||||Serotype 19F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.14|0.71|
73908537|NCT02124161|147347001|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.56|1.03||||||Serotype 23F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.03|0.56|
73908538|NCT02124161|147347002|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.18||||||Strain A/H1N1: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.18|0.88|
73908539|NCT02124161|147347002|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.2|||||TWO_SIDED|95.0|1.01|1.32||||||Strain A/H3N2: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.32|1.01|
73908540|NCT02124161|147347002|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.24||||||Strain B/Brisbane: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.24|0.95|
73971307|NCT01959607|147483153|OTHER||Geometric LS Mean Ratio|103.5|||||TWO_SIDED|95.0|84.94|126.11|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||126.11|84.94|
74026135|NCT01877655|147605418|SUPERIORITY||Odds Ratio (OR)|1.05||||0.802|TWO_SIDED|95.0|0.73|1.51||P value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor recipient relatedness and donor CMV serostatus.|Analysis of composite of CMV viremia and adjudicated CMV-AVT. The CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.||1.51|0.73|0.802
73908541|NCT02124161|147347002|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.21||||||Strain B/Massachusetts: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.21|0.90|
73908542|NCT02124161|147347005|SUPERIORITY_OR_OTHER||Percentage Difference|2.8|||||TWO_SIDED|95.0|-1.9|7.4||||||AE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.||7.4|-1.9|
73908543|NCT02124161|147347005|SUPERIORITY_OR_OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||SAE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.||1.7|-1.8|
73908544|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|-2.8||||0.333|TWO_SIDED|95.0|-8.3|2.8|||Chan and Zhang method|||Serotype 1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||2.8|-8.3|0.333
73908545|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|-4.3||||0.105|TWO_SIDED|95.0|-9.6|0.9|||Chan and Zhang method|||Serotype 3: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.9|-9.6|0.105
73908546|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|-3.5||||0.09|TWO_SIDED|95.0|-7.6|0.6|||Chan and Zhang method|||Serotype 4: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.6|-7.6|0.090
73908547|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|1.8||||0.59|TWO_SIDED|95.0|-4.2|7.8|||Chan and Zhang method|||Serotype 5: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||7.8|-4.2|0.590
73908548|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|-3.7||||0.044|TWO_SIDED|95.0|-7.5|-0.1|||Chan and Zhang method|||Serotype 6A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||-0.1|-7.5|0.044
73908549|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|-1.4||||0.574|TWO_SIDED|95.0|-6.2|3.4|||Chan and Zhang method|||Serotype 6B: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||3.4|-6.2|0.574
73908550|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|-1.2||||0.648|TWO_SIDED|95.0|-6.3|3.9|||Chan and Zhang method|||Serotype 7F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||3.9|-6.3|0.648
73908551|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|-6.2||||0.057|TWO_SIDED|95.0|-12.5|0.2|||Chan and Zhang method|||Serotype 9V: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.2|-12.5|0.057
73908552|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|-3.7||||0.03|TWO_SIDED|95.0|-7.3|-0.3|||Chan and Zhang method|||Serotype 14: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||-0.3|-7.3|0.030
73964539|NCT04992390|147464642|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|1.5|||>|0.05|TWO_SIDED|95.0|0.64|3.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for Sickness absence (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|3.51|0.64|> .05
73964540|NCT04992390|147464643|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.86|||>|0.05|TWO_SIDED|95.0|-2.2|0.49||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intention to leave job (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.49|-2.20|> .05
73908553|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|-2.5||||0.233|TWO_SIDED|95.0|-6.6|1.6|||Chan and Zhang method|||Serotype 18C: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||1.6|-6.6|0.233
73908554|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|-1.8||||0.152|TWO_SIDED|95.0|-4.5|0.7|||Chan and Zhang method|||Serotype 19A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.7|-4.5|0.152
73908555|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.926|TWO_SIDED|95.0|-5.1|5.8|||Chan and Zhang method|||Serotype 19F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||5.8|-5.1|0.926
73908556|NCT02124161|147347007|SUPERIORITY_OR_OTHER||Percentage Difference|-3.9||||0.143|TWO_SIDED|95.0|-9.1|1.3|||Chan and Zhang method|||Serotype 23F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||1.3|-9.1|0.143
73908557|NCT02124161|147347010|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|5.1||||0.094|TWO_SIDED|95.0|-0.9|11.0|||Chan and Zhang method|||Strain A/H1N1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||11.0|-0.9|0.094
73908558|NCT02124161|147347010|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-3.8||||0.232|TWO_SIDED|95.0|-9.9|2.4|||Chan and Zhang method|||Strain A/H3N2: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||2.4|-9.9|0.232
73908559|NCT02124161|147347010|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.0||||0.734|TWO_SIDED|95.0|-6.6|4.5|||Chan and Zhang method|||Strain B/Brisbane: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||4.5|-6.6|0.734
73964541|NCT04992390|147464644|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|0.8|||>|0.05|TWO_SIDED|95.0|0.6|1.07||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for number of days worked (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|1.07|0.60|>.05
73964542|NCT04992390|147464645|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|1.09|||<|0.05|TWO_SIDED|95.0|0.57|2.09||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for number of nights worked (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|2.09|0.57|<.05
73964543|NCT02807779|147464652|SUPERIORITY|||||||0.22||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||"Power calculations were performed based on an expected reproducibility variance of 8% and an effect size of 7% was assumed based on data from pilot studies. It was estimated that 22 subjects/treatment assignment were needed to detect a 7% difference in PWV at a power level of 80%. Assigning a 20% attrition rate due to loss to follow up or index lesion revascularization, the goal enrollment was 27 subjects per arm.~No subjects in the plain balloon angioplasty group had MRI data for analysis."||||0.22
73964544|NCT02807779|147464653|SUPERIORITY|||||||0.64||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||0.64
73964545|NCT02807779|147464654|SUPERIORITY|||||||0.95||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had complete MCP-1 data for analysis.||||0.95
73857484|NCT05275010|147260272|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the Cmax values for pertuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.96|1.12|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.12|0.96|
73964546|NCT02807779|147464655|SUPERIORITY|||||||0.88||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had complete CRP data for analysis.||||0.88
73964547|NCT02807779|147464657|SUPERIORITY|||||||0.055||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||.055
73857485|NCT05275010|147260273|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the Cmax values for trastuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.95|1.13|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.13|0.95|
73857486|NCT02449889|147260323|NON_INFERIORITY|Treatment comparisons were done in a sequential manner. First non-inferiority (NI) was tested for HP-hCG IM compared to rhCG SC (lower limit of the 95% confidence interval (CI) \> -3.0). If NI was demonstrated, NI was also to be tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.8|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC||1.8|-0.6|
73857487|NCT02449889|147260323|NON_INFERIORITY|As step 2 in the pre-specified sequential testing, NI was tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-0.5|2.0|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC||2.0|-0.5|
73857488|NCT02449889|147260324|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.6|1.5|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of MII oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC||1.5|-0.6|
73908560|NCT02124161|147347010|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.5||||0.627|TWO_SIDED|95.0|-7.2|4.3|||Chan and Zhang method|||Strain B/Massachusetts: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||4.3|-7.2|0.627
73908561|NCT01147640|147347034|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.4|||||TWO_SIDED|||||||||||||
73964548|NCT02807779|147464658|SUPERIORITY|||||||0.22||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||.22
73964549|NCT02807779|147464659|SUPERIORITY|||||||0.81||||||Threshold for statistical significance was p=0.05.|Fisher Exact|||||||0.81
73964550|NCT01853748|147464702|SUPERIORITY|||||||0.0012|||||||Mantel Haenszel|||||||0.0012
73908562|NCT01147640|147347035|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.2|||||TWO_SIDED|95.0||||||||||||
73908563|NCT00091442|147347045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5988||95.0|0.86|1.3||Not adjusted for multiple comparison.|Log Rank|||Null Hypothesis: Designed to detect an improvement in median survival from 15 months to 19.5 months with 80% power.||1.3|0.86|0.5988
73908564|NCT00091442|147347046|SUPERIORITY_OR_OTHER|||||||0.0085||95.0||||Not adjusted for multiple comparison|Cochran-Mantel-Haenszel|||Null hypothesis - no difference in response rate between the two treatment groups.||||0.0085
73908565|NCT00091442|147347047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001||95.0|0.55|0.77|||Log Rank|||"Null hypothersis - no difference in Time to Progression (TTP) between the two treatment groups.~Designed to detect an improvement in median TTP from 6 months to 7.8 months with 80% power, assuming exponential survival distribution."||0.77|0.55|<0.0001
73908566|NCT04041375|147347098|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.09||||0.42|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Total Score - Treatment Effect - Month 3||||0.42
73908567|NCT04041375|147347098|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.32|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Emotional Burden Subscale - Treatment Effect - Month 3||||0.32
73908568|NCT04041375|147347098|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.36|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physician-Related Distress Subscale - Treatment Effect - Month 3||||0.36
73908569|NCT04041375|147347098|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.17||||0.23|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Regimen-Related Distress Subscale - Treatment Effect - Month 3||||0.23
73908570|NCT04041375|147347098|SUPERIORITY|Treatment effect was modeled via multilevel linear regression model with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.18||||0.26|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Interpersonal Distress Subscale - Treatment Effect - Month 3||||0.26
73908571|NCT04041375|147347098|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Treatment Effect|0.007||||0.95|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Total Score - Treatment Effect - Month 6||||0.95
73908572|NCT04041375|147347098|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.01||||0.92|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Emotional Burden Subscale - Treatment Effect - Month 6||||0.92
73908573|NCT04041375|147347098|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.07||||0.59|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physician-Related Distress Subscale - Treatment Effect - Month 6||||0.59
73908574|NCT04041375|147347098|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.08||||0.54|TWO_SIDED|||||alpha = 0.05|Interaction Term|||Regimen-Related Distress Subscale - Treatment Effect - Month 6||||0.54
73964551|NCT01853748|147464707|SUPERIORITY|||||||0.0001|||||||Regression, Linear|||||||0.0001
73964552|NCT01853748|147464710|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
73964553|NCT02576509|147464719|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0752|TWO_SIDED|95.0|0.71|1.02||A priori threshold for statistical significance is 0.0419|Log Rank|Log-rank Test stratified by the stratification factors as entered into the IVRS|Nivolumab over Sorafenib; Stratified Cox proportional hazard model||95.81% CI ADJUSTED FOR MULTIPLICITY: (0.72 to 1.02)|1.02|0.71|0.0752
73964554|NCT02576509|147464720|OTHER|no test was performed due to OS p-value result above the prior threshold|Difference of ORRs|8.3|||||TWO_SIDED|95.0|3.9|12.7|||||Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors|||12.7|3.9|
73908575|NCT04041375|147347098|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.3||||0.05|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Interpersonal Distress Subscale - Treatment Effect - Month 6||||0.05
73908576|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.58||||0.03|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||General Diet - Treatment Effect - Month 3||||0.03
73908577|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.07||||0.83|TWO_SIDED||||||Mixed Models Analysis|||Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 3||||0.83
73908578|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.44||||0.12|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fat) - Treatment Effect - Month 3||||0.12
73908579|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.39||||0.17|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physical Activity - Treatment Effect - Month 3||||0.17
73908580|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.06||||0.85|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Blood Glucose Testing - Treatment Effect - Month 3||||0.85
73908581|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.02||||0.94|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Foot Care - Treatment Effect - Month 3||||0.94
73908582|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.19||||0.47|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||General Diet - Treatment Effect - Month 6||||0.47
73908583|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.08||||0.82|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 6||||0.82
73908584|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.66|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fat) - Treatment Effect - Month 6||||0.66
73964555|NCT02576509|147464720|OTHER|no test was performed due to OS p-value result above the prior threshold|Odds Ratio (OR)|2.41|||||TWO_SIDED|95.0|1.48|3.92|||||Nivolumab over Sorafenib; Mantel-Haenszel estimator|||3.92|1.48|
73964556|NCT02576509|147464721|OTHER|no test was performed due to OS p-value result above the prior threshold|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.1|||||Nivolumab over Sorafenib; Stratified Cox proportional hazard model|||1.10|0.79|
73964557|NCT02576509|147464722|OTHER|PD-L1 \>= 1%, OS; no test was performed|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.19|||||Nivolumab over Sorafenib|||1.19|0.54|
73964558|NCT02576509|147464722|OTHER|PD-L1 \>=1%, PFS; no test was performed|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.48|1.03|||||Nivolumab over Sorafenib|||1.03|0.48|
73964559|NCT02576509|147464722|OTHER|PD-L1 \<1%, OS; no test was performed|Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.69|1.02|||||Nivolumab over Sorafenib|||1.02|0.69|
73964560|NCT02576509|147464722|OTHER|PD-L1 \<1%, PFS; no test was performed|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.81|1.17|||||Nivolumab over Sorafenib|||1.17|0.81|
73964561|NCT02576509|147464722|OTHER|without PD-L1 quantifiable, OS; no test was performed|Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.34|4.74|||||Nivolumab over Sorafenib|||4.74|0.34|
73908585|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.25||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physical Activity - Treatment Effect - Month 6||||0.38
73964562|NCT02576509|147464722|OTHER|without PD-L1 quantifiable, PFS; no test was performed|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.27|3.52|||||Nivolumab over Sorafenib|||3.52|0.27|
73964563|NCT02576509|147464723|OTHER|PD-L1 \>=1%, ORR; no test was performed|Odds Ratio (OR)|3.79|||||TWO_SIDED|95.0|1.41|10.17|||||Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI.|||10.17|1.41|
73964564|NCT02576509|147464723|OTHER|PD-L1 \<1%, ORR; no test was performed|Odds Ratio (OR)|1.95|||||TWO_SIDED|95.0|1.1|3.45|||||Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI|||3.45|1.10|
73964565|NCT06546657|147464738|OTHER||Mean Difference (Final Values)|1.74||||0.14|TWO_SIDED|95.0|-0.6|4.0||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||Medium GI vs low GI breakfast meals||4.0|-0.6|0.14
73964566|NCT06546657|147464738|OTHER||Mean Difference (Final Values)|4.4||||0.01|TWO_SIDED|95.0|1.2|7.5|||Linear Mixed Model|||Medium vs high GI breakfast meals||7.5|1.2|0.01
73908586|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.12||||0.68|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Blood Glucose Testing - Treatment Effect - Month 6||||0.68
73908587|NCT04041375|147347099|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.26||||0.4|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Foot Care - Treatment Effect - Month 6||||0.40
73908588|NCT04041375|147347101|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.06||||0.93|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.93
73908589|NCT04041375|147347101|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.63||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.38
73908590|NCT04041375|147347102|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.32||||0.66|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.66
73908591|NCT04041375|147347102|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.99||||0.18|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.18
73908592|NCT04041375|147347105|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|1.45||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.38
73908593|NCT04041375|147347105|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|1.64||||0.68|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.68
73908594|NCT04041375|147347106|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.19||||0.74|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.74
73908595|NCT04041375|147347106|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.29||||0.62|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.62
73908596|NCT04041375|147347107|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.16||||0.72|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.72
73908597|NCT04041375|147347107|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.24||||0.58|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.58
73908598|NCT04041375|147347108|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.36||||0.5|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.50
73908599|NCT04041375|147347108|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.72||||0.18|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.18
73908600|NCT04981392|147347117|SUPERIORITY||Cox Proportional Hazard|0.49|STANDARD_ERROR_OF_MEAN|0.18||0.0066|TWO_SIDED||||||Difference in adjusted % vaccinated|||||||0.0066
73908601|NCT04981392|147347118|SUPERIORITY||Cox Proportional Hazard|0.83|STANDARD_ERROR_OF_MEAN|0.3||0.0058|TWO_SIDED||||||Difference in adjusted % vaccinated|||||||0.0058
73908602|NCT01033851|147347122|SUPERIORITY_OR_OTHER|||||||0.0366||95.0|||||ANOVA|||A repeated measure ANOVA, with time as the repeated measure, treatment arm as between-subjects factor and CGI-S score as the dependent variable, found a main effect of time (F(1,84)=62.19, p\<0.001) and a significant treatment arm X time interaction (F(1,84)=4.51, p=0.0366).||||0.0366
73908603|NCT00543543|147347129|SUPERIORITY_OR_OTHER||Vaccine efficacy|96.7|||<|0.0001|TWO_SIDED|95.0|80.9|99.8|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||99.8|80.9|<0.0001
73964567|NCT06546657|147464738|OTHER||Mean Difference (Final Values)|-2.63||||0.12|TWO_SIDED|95.0|-6.0|0.7||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||High GI vs low GI breakfast meals||0.7|-6.0|0.12
73908604|NCT00543543|147347130|SUPERIORITY_OR_OTHER||Vaccine efficacy|97.4|||||TWO_SIDED|95.0|85.0|99.9|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||99.9|85.0|
73908605|NCT00543543|147347131|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.99|1.06|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 6||1.06|0.99|<0.001
73908606|NCT00543543|147347131|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.77|0.83|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 11||0.83|0.77|<0.001
73964568|NCT06546657|147464739|OTHER||Mean Difference (Final Values)|0.1815||||0.65|TWO_SIDED||||||Linear Mixed Model|||High GI breakfast meals vs low and medium GI breakfast meals||||0.65
73908607|NCT00543543|147347131|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.96|1.03|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 16||1.03|0.96|<0.001
73908608|NCT00543543|147347131|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.14|1.23|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 18||1.23|1.14|<0.001
73908609|NCT00543543|147347138|SUPERIORITY_OR_OTHER||Vaccine efficacy|96.0|||||TWO_SIDED|95.0|94.6|97.1|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||97.1|94.6|
73908610|NCT04308304|147347160|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.69|||||TWO_SIDED|90.0|0.55|0.86||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.86|0.55|
73908611|NCT04308304|147347160|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.66|||||TWO_SIDED|95.0|0.53|0.82||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.82|0.53|
73908612|NCT04308304|147347160|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.00|0.55|
73908613|NCT04308304|147347160|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.77|||||TWO_SIDED|95.0|0.56|1.05||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.05|0.56|
73964569|NCT06546657|147464740|OTHER||Mean Difference (Final Values)|0.431||||0.25|TWO_SIDED|95.0|-0.3|1.2|||Linear Mixed Model|||High glycaemic load breakfast meals vs low and medium glycaemic load meals||1.2|-0.3|0.25
73964570|NCT06546657|147464741|OTHER||Mean Difference (Final Values)|22.0||||0.04|TWO_SIDED|95.0|0.6|44.0|||Linear Mixed Model|||High glycaemic load breakfast meals vs low and medium glycaemic load meals||44|0.6|0.04
73964571|NCT06546657|147464742|OTHER||Mean Difference (Final Values)|1.3||||0.01|TWO_SIDED|95.0|0.4|2.1|||Linear Mixed Model|||Breakfast cereals meals vs added protein meals||2.1|0.4|0.01
73964572|NCT06546657|147464744|OTHER|Comparison of diurnal and nocturnal glucose variability (CV%)|Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73964573|NCT03725722|147464752|SUPERIORITY||||||<|0.0001||||||"P-values were adjusted for multiple comparisons. Models with adjusted p-value of \<0.025 were stat. sign. diff. from a flat dose-response model.~Model selected: Sigmoid Emax model"|Multiple contrast test|||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 8 in EASI score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.||||<0.0001
73964574|NCT03725722|147464752|SUPERIORITY||Mean Difference (Net)|-3.1|||<|0.01|TWO_SIDED|95.0|-5.0|-1.3||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-1.3|-5.0|<0.01
73964575|NCT03725722|147464752|SUPERIORITY||Mean Difference (Net)|-3.0|||<|0.05|TWO_SIDED|95.0|-4.8|-1.2||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-1.2|-4.8|<0.05
73908614|NCT04308304|147347161|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.69|||||TWO_SIDED|90.0|0.55|0.86||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.86|0.55|
73908615|NCT04308304|147347161|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.66|||||TWO_SIDED|95.0|0.53|0.82||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.82|0.53|
73908616|NCT04308304|147347161|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.00|0.55|
73908617|NCT04308304|147347161|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.77|||||TWO_SIDED|95.0|0.56|1.05||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.05|0.56|
73971308|NCT01959607|147483154|OTHER||Geometric LS Mean Ratio|96.34|||||TWO_SIDED|95.0|85.1|109.07|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||109.07|85.10|
73908618|NCT04308304|147347162|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.67|||||TWO_SIDED|90.0|0.52|0.87||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.87|0.52|
73971309|NCT03785964|147483155|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.15|0.55|||Log Rank|p-value was from a one-sided stratified log-rank test with placebo as reference.||Hazard ratio was estimated from stratified Cox proportional hazards model using the exact method for ties, stratified by tumor location. Placebo was the reference treatment.||0.55|0.15|< 0.001
73908619|NCT04308304|147347162|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.68|||||TWO_SIDED|95.0|0.52|0.87||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.87|0.52|
73908620|NCT04308304|147347162|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.79|||||TWO_SIDED|95.0|0.59|1.06||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.06|0.59|
73908621|NCT04308304|147347162|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.74|||||TWO_SIDED|95.0|0.51|1.08||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.08|0.51|
73908622|NCT04308304|147347163|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.62|||||TWO_SIDED|90.0|0.48|0.8||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.80|0.48|
73908623|NCT04308304|147347163|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.67|||||TWO_SIDED|95.0|0.55|0.81||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.81|0.55|
73908624|NCT04308304|147347163|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.68|||||TWO_SIDED|95.0|0.49|0.93||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.93|0.49|
73908625|NCT04308304|147347163|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.72|||||TWO_SIDED|95.0|0.54|0.98||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.98|0.54|
73908626|NCT04308304|147347168|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.34|STANDARD_ERROR_OF_MEAN|52.4||||||||||||||||
73908627|NCT04308304|147347169|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.22|STANDARD_ERROR_OF_MEAN|52.4||||||||||||||||
73971310|NCT03785964|147483156|SUPERIORITY||||||<|0.001||||||Two-sided p-value|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test for general association stratified by tumor location. Placebo was reference treatment.||||< 0.001
73971311|NCT03785964|147483157|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline Brief Pain Inventory Short Form score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 31 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
73908628|NCT04308304|147347170|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.46|STANDARD_ERROR_OF_MEAN|60.8||||||||||||||||
73908629|NCT01686828|147347192|SUPERIORITY_OR_OTHER|||||||0.164||||||The a prior threshold for statistical significance was p\<0.05.|RM-ANOVA|||||||0.164
73908630|NCT01686828|147347193|SUPERIORITY_OR_OTHER|||||||0.003|||||||RM-ANOVA|||Time-by-group interaction for fat mass||||0.003
73908631|NCT01686828|147347193|SUPERIORITY_OR_OTHER|||||||0.03||||||Time-by-group interaction for lean mass|RM-ANOVA|||||||0.03
73908632|NCT01686828|147347194|OTHER||||||>|0.1|||||||ANOVA|||The null hypothesis was that short-term testosterone deprivation would not affect lipoprotein lipase expression in adipose tissue. Repeated measures ANOVA was used to determine if a time-by-group effect was apparent for lipoprotein lipase expression.||||>0.1
73908633|NCT02130024|147347245|OTHER||Treatment Effect|0.08||||0.236|TWO_SIDED|95.0|-0.05|0.21|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject||||0.21|-0.05|0.236
73908634|NCT02130024|147347246|OTHER||Treatment Effect|0.02||||0.769|TWO_SIDED|95.0|-0.11|0.15|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject||||0.15|-0.11|0.769
73908635|NCT02130024|147347247|OTHER||Odds Ratio (OR)|0.84||||0.586|TWO_SIDED|95.0|0.44|1.59|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Baseline to Month 12 Analysis||1.59|0.44|0.586
73908636|NCT02130024|147347247|OTHER||Odds Ratio (OR)|2.27||||0.11|TWO_SIDED|95.0|0.83|6.22|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Month 12 to Month 24 Analysis||6.22|0.83|0.110
73908637|NCT02130024|147347247|OTHER||Odds Ratio (OR)|1.19||||0.554|TWO_SIDED|95.0|0.67|2.09|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment||Baseline to Month 24 Analysis||2.09|0.67|0.554
73908638|NCT02130024|147347248|OTHER||Treatment Effect|0.99||||0.733|TWO_SIDED|95.0|0.95|1.04|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to \<Month 12 Analysis||1.04|0.95|0.733
73908639|NCT02130024|147347248|OTHER||Treatment Effect|1.01||||0.745|TWO_SIDED|95.0|0.95|1.08|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to Month 24 Analysis||1.08|0.95|0.745
73908640|NCT02130024|147347249|OTHER||Treatment Effect|2.32||||0.079|TWO_SIDED|95.0|-0.27|4.92|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis||4.92|-0.27|0.079
73908641|NCT02130024|147347249|OTHER||Treatment Effect|1.95||||0.151|TWO_SIDED|95.0|-0.71|4.61|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis||4.61|-0.71|0.151
73908642|NCT02130024|147347250|OTHER||Treatment Effect|10.12||||0.294|TWO_SIDED|95.0|-8.82|29.06|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis||29.06|-8.82|0.294
73908643|NCT02130024|147347250|OTHER||Treatment Effect|11.86||||0.225|TWO_SIDED|95.0|-7.35|31.07|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis||31.07|-7.35|0.225
73908644|NCT02130024|147347251|OTHER||Odds Ratio (OR)|0.83||||0.461|TWO_SIDED|95.0|0.51|1.35|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 2 Analysis||1.35|0.51|0.461
73908645|NCT02130024|147347251|OTHER||Odds Ratio (OR)|0.72||||0.215|TWO_SIDED|95.0|0.44|1.21|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 12 Analysis||1.21|0.44|0.215
73908646|NCT02130024|147347251|OTHER||Odds Ratio (OR)|0.87||||0.616|TWO_SIDED|95.0|0.51|1.48|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 24 Analysis||1.48|0.51|0.616
73908647|NCT02130024|147347252|OTHER||Odds Ratio (OR)|1.05||||0.891|TWO_SIDED|95.0|0.53|2.08|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis||2.08|0.53|0.891
73908648|NCT02130024|147347252|OTHER||Odds Ratio (OR)|1.61||||0.206|TWO_SIDED|95.0|0.77|3.35|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis||3.35|0.77|0.206
73908649|NCT02130024|147347253|OTHER||Odds Ratio (OR)|1.63||||0.46|TWO_SIDED|95.0|0.45|5.93|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis||5.93|0.45|0.460
73908650|NCT02130024|147347253|OTHER||Odds Ratio (OR)|0.94||||0.913|TWO_SIDED|95.0|0.3|2.9|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis||2.90|0.30|0.913
73908651|NCT02130024|147347255|OTHER||Treatment Effect|27.2|||<|0.001|TWO_SIDED|95.0|21.44|32.95|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 5 Analysis||32.95|21.44|<0.001
73908652|NCT02130024|147347255|OTHER||Treatment Effect|28.88|||<|0.001|TWO_SIDED|95.0|23.08|34.68|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 9 Analysis||34.68|23.08|<0.001
74026136|NCT01877655|147605419|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.8|1.28||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of rate of adjudicated CMV AVT or CMV EOD. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD and were determined by the adjudication committee. Rate based on cumulative incidence function estimate at 1 year.||1.28|0.80|0.928
73908653|NCT02484690|147347260|SUPERIORITY||Difference in Least Squares Means|1.57||||0.5244|TWO_SIDED|80.0|-1.6|4.74||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||4.74|-1.60|0.5244
73908654|NCT02484690|147347260|SUPERIORITY||Difference in Least Squares Means|-1.59||||0.5308|TWO_SIDED|80.0|-4.86|1.67||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||1.67|-4.86|0.5308
73908655|NCT02484690|147347260|SUPERIORITY||Difference in Least Squares Means|-1.51||||0.5309|TWO_SIDED|80.0|-4.62|1.59||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.59|-4.62|0.5309
73908656|NCT02484690|147347261|SUPERIORITY||Difference in Least Squares Means|-1.68||||0.3034|TWO_SIDED|80.0|-3.77|0.42||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that the Arm E mean was different from Arm A mean.||0.42|-3.77|0.3034
73908657|NCT02484690|147347262|SUPERIORITY||Difference in Least Squares Means|5.63||||0.5527|TWO_SIDED|80.0|-6.52|17.77||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||17.77|-6.52|0.5527
73908658|NCT02484690|147347262|SUPERIORITY||Difference in Least Squares Means|-3.09||||0.7382|TWO_SIDED|80.0|-14.95|8.76||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||8.76|-14.95|0.7382
73908659|NCT02484690|147347262|SUPERIORITY||Difference in Least Squares Means|-7.32||||0.3932|TWO_SIDED|80.0|-18.32|3.67||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||3.67|-18.32|0.3932
73908660|NCT02484690|147347263|SUPERIORITY||Difference in Percentage of Participants|-5.71||||0.2328|TWO_SIDED|80.0|-10.74|-0.69||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||-0.69|-10.74|0.2328
73964576|NCT03725722|147464752|SUPERIORITY||Mean Difference (Net)|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.8|-2.1||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-2.1|-5.8|<0.0001
73908661|NCT02484690|147347264|SUPERIORITY||Difference in Least Squares Means|-0.52||||0.9581|TWO_SIDED|80.0|-13.26|12.22||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||12.22|-13.26|0.9581
73908662|NCT02484690|147347264|SUPERIORITY||Difference in Least Squares Means|-10.08||||0.3166|TWO_SIDED|80.0|-22.99|2.82||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.82|-22.99|0.3166
73908663|NCT02484690|147347264|SUPERIORITY||Difference in Least Squares Means|-7.68||||0.4244|TWO_SIDED|80.0|-20.01|4.64||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||4.64|-20.01|0.4244
73964577|NCT03725722|147464752|SUPERIORITY||Median Difference (Net)|-5.7|||<|0.0001|TWO_SIDED|95.0|-7.5|-3.9||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-3.9|-7.5|<0.0001
73964578|NCT03725722|147464753|SUPERIORITY||||||<|0.0001||||||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Multiple contrast test|"P-values adj. for multiple comparisons. Models with adj. p-value \<0.025 were stat. sign. diff. from a flat dose-response model.~Model: Linear model"||This endpoint was evaluated by determining if there was a dose-response relationship between the vIGA-AD response rate at Week 8 and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response.||||<0.0001
73964579|NCT03725722|147464753|SUPERIORITY||Risk Difference (RD)|8.2|||>|0.05|TWO_SIDED|95.0|-5.6|21.9||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference.||21.9|-5.6|>0.05
73964580|NCT03725722|147464753|SUPERIORITY||Risk Difference (RD)|19.3|||<|0.05|TWO_SIDED|95.0|3.9|34.6||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference.||34.6|3.9|<0.05
73964581|NCT03725722|147464753|SUPERIORITY||Risk Difference (RD)|20.3|||<|0.05|TWO_SIDED|95.0|5.4|35.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||35.2|5.4|<0.05
73964582|NCT03725722|147464753|SUPERIORITY||Risk Difference (RD)|38.3|||<|0.0001|TWO_SIDED|95.0|22.3|54.3||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||54.3|22.3|<0.0001
73964583|NCT03725722|147464754|SUPERIORITY||||||<|0.0001||||||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Multiple contrast test|"P-values were adj. for multiple comparisons. Models with adj. p-value \<0.025 were stat. sign. diff. from a flat dose-response model.~Model:Emax model"||This endpoint was evaluated by determining if there was a dose-response relationship between EASI75 at Week 8 and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response||||<0.0001
73908664|NCT02484690|147347265|SUPERIORITY||Difference in Percentage of Participants|-6.64||||0.5586|TWO_SIDED|80.0|-18.6|5.32||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||5.32|-18.60|0.5586
73908665|NCT02484690|147347266|SUPERIORITY||Difference in Least Squares Means|1.0||||0.8536|TWO_SIDED|80.0|-5.93|7.93||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||7.93|-5.93|0.8536
73857489|NCT02449889|147260324|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.4|1.6|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of Mll oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC||1.6|-0.4|
73857490|NCT02449889|147260325|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.6|1.3|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG IM versus rhCG SC||1.3|-0.6|
73857491|NCT02449889|147260325|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.5|1.4|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG SC versus rhCG SC.||1.4|-0.5|
73857492|NCT03327220|147260330|SUPERIORITY||Difference in Means|1.3||||0.0841|TWO_SIDED|95.0|-0.6|3.2||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing null hypothesis that true iovera° mean was greater than or equal to the true standard of care mean versus the alternative hypothesis that true iovera° mean was less than true standard of care mean.||3.2|-0.6|0.0841
73857493|NCT03327220|147260331|NON_INFERIORITY|The objective met if the t-test for non-inferiority was statistically significant using a one-sided α = 0.025 level of statistical significance.|Difference in Means|1.9|||<|0.0001|TWO_SIDED|95.0|-2.3|6.1||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing null hypothesis that Standard of Care mean minus the iovera° mean was greater than or equal to non-inferiority margin of 14 versus alternative hypothesis that difference in means was less than 14.||6.1|-2.3|<0.0001
73857494|NCT03327220|147260332|SUPERIORITY||Difference in Means|0.5||||0.0946|TWO_SIDED|95.0|-0.2|1.2||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Pain in the Past 7 days - Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.||1.2|-0.2|0.0946
73857495|NCT03327220|147260332|SUPERIORITY|Pain Right Now - Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.|Difference in Means|0.4||||0.2204|TWO_SIDED|95.0|-0.6|1.3||p-value was calculated from a one-sided, two-sample t-test,|t-test, 1 sided|||||1.3|-0.6|0.2204
73857496|NCT03327220|147260333|SUPERIORITY||Difference in Means|-0.8||||0.3231|TWO_SIDED|95.0|-4.0|2.5||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.||2.5|-4.0|0.3231
73857497|NCT03622112|147260430|SUPERIORITY||Mean Difference (Final Values)|-0.036||||0.437|TWO_SIDED|95.0|-0.126|0.054|||Mixed Models Analysis|||||0.054|-0.126|0.437
73908666|NCT02484690|147347266|SUPERIORITY||Difference in Least Squares Means|8.14||||0.2303|TWO_SIDED|80.0|-0.56|16.83||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||16.83|-0.56|0.2303
73857498|NCT03622112|147260430|SUPERIORITY||Mean Difference (Final Values)|-0.054||||0.236|TWO_SIDED|95.0|-0.143|0.035|||Mixed Models Analysis|||||0.035|-0.143|0.236
73857499|NCT03622112|147260430|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.389|TWO_SIDED|95.0|-0.05|0.128|||Mixed Models Analysis|||||0.128|-0.050|0.389
73857500|NCT03622112|147260430|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.094|TWO_SIDED|95.0|-0.013|0.165|||Mixed Models Analysis|||||0.165|-0.013|0.094
73857501|NCT03622112|147260430|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.06|TWO_SIDED|95.0|-0.003|0.167|||Mixed Models Analysis|||||0.167|-0.003|0.060
73857502|NCT03622112|147260430|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.014|TWO_SIDED|95.0|0.023|0.199|||Mixed Models Analysis|||||0.199|0.023|0.014
73857503|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.463|TWO_SIDED|95.0|-0.048|0.105|||Mixed Models Analysis|||Week 2||0.105|-0.048|0.463
73857504|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.576|TWO_SIDED|95.0|-0.055|0.098|||Mixed Models Analysis|||Week 2||0.098|-0.055|0.576
73857505|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.047|TWO_SIDED|95.0|0.001|0.154|||Mixed Models Analysis|||Week 2||0.154|0.001|0.047
73857506|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.009|TWO_SIDED|95.0|0.025|0.179|||Mixed Models Analysis|||Week 2||0.179|0.025|0.009
73857507|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.104||||0.006|TWO_SIDED|95.0|0.031|0.178|||Mixed Models Analysis|||Week 2||0.178|0.031|0.006
73857508|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.003|TWO_SIDED|95.0|0.041|0.194|||Mixed Models Analysis|||Week 2||0.194|0.041|0.003
73964584|NCT03725722|147464754|SUPERIORITY||Risk Difference (RD)|19.7|||<|0.05|TWO_SIDED|95.0|1.8|37.6||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||37.6|1.8|<0.05
73964585|NCT03725722|147464754|SUPERIORITY||Risk Difference (RD)|23.5|||<|0.05|TWO_SIDED|95.0|5.8|41.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||41.2|5.8|<0.05
73964586|NCT03725722|147464754|SUPERIORITY||Risk Difference (RD)|35.3|||<|0.0005|TWO_SIDED|95.0|17.5|53.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||53.2|17.5|<0.0005
73964587|NCT03725722|147464754|SUPERIORITY||Risk Difference (RD)|45.4|||<|0.0001|TWO_SIDED|95.0|28.1|62.8||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||62.8|28.1|<0.0001
73964588|NCT03725722|147464755|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner.||||>0.05
73964589|NCT03725722|147464755|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||"vIGA-AD was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner.||||>0.05
73964590|NCT03725722|147464755|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||The statistical test was not controlled for multiplicity|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner||||>0.05
74026137|NCT01877655|147605420|SUPERIORITY||Odds Ratio (OR)|1.18||||0.393|TWO_SIDED|95.0|0.81|1.73||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Analysis of all-cause mortality at 1 year. Participants with unknown survival status at 1 year were considered dead for this analysis.||1.73|0.81|0.393
74026138|NCT03191786|147605447|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.025|TWO_SIDED|95.0|0.63|0.97|||Log Rank|||Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.||0.97|0.63|0.025
74026139|NCT03191786|147605448|SUPERIORITY||Difference in OS Rates|6.5|||||TWO_SIDED|95.0|-3.3|16.3||||||OS Rate at 6 Months||16.3|-3.3|
74026140|NCT03191786|147605448|SUPERIORITY||Difference in OS Rates|5.1|||||TWO_SIDED|95.0|-4.9|15.0||||||OS Rate at 12 Months||15.0|-4.9|
74085220|NCT00513617|147724089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.098|STANDARD_ERROR_OF_MEAN|0.0713||0.133||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.133
73964591|NCT03725722|147464755|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD|||||<|0.001||||||The statistical test was not controlled for multiplicity|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner||||<0.001
73964592|NCT05505045|147464760|OTHER||Cohen's d effect size|0.44|||||TWO_SIDED|95.0|-0.16|1.05||||||||1.05|-.16|
73964593|NCT05505045|147464761|OTHER||Cohen's d effect size|0.42|||||TWO_SIDED|95.0|-0.19|1.03||||||||1.03|-.19|
73964594|NCT05505045|147464762|OTHER||Cohen's d effect size|0.31|||||TWO_SIDED|95.0|-0.3|0.93||||||||0.93|-.30|
73964595|NCT05505045|147464763|OTHER||Cohen's d effect size|-0.42|||||TWO_SIDED|96.0|-1.04|0.21||||||||0.21|-1.04|
73964596|NCT05505045|147464768|OTHER||Cohen's d effect size|0.01|||||TWO_SIDED|95.0|-0.61|0.64||||||||.64|-.61|
73964597|NCT03397108|147464771|SUPERIORITY|||||||0.89||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk TNF levels at EARLY LACTATION PERIOD were compared between non-IBD control and women with IBD. Our hypothesis was that women with IBD have higher TNF in milk due to the underlying inflammatory condition (IBD).||||0.89
73964598|NCT03397108|147464771|SUPERIORITY|||||||0.024|||||||Kruskal-Wallis|||"Milk TNF at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.024
73964599|NCT03397108|147464771|SUPERIORITY|||||||0.7||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MCP1 levels (TNF dependent chemokine) at the EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.70
73964600|NCT03397108|147464771|SUPERIORITY|||||||0.93||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk levels of MIP-1 beta (TNF dependent chemokine) at the EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.93
73964601|NCT03397108|147464771|SUPERIORITY|||||||0.12||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk IP10 levels (one of the TNF dependent chemokines) at EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.12
74026141|NCT03191786|147605448|SUPERIORITY||Difference in OS Rates|7.4|||||TWO_SIDED|95.0|-1.6|16.5||||||OS Rate at 18 Months||16.5|-1.6|
74026142|NCT03191786|147605448|SUPERIORITY||Difference in OS Rates|11.9|||||TWO_SIDED|95.0|4.4|19.5||||||OS Rate at 24 Months||19.5|4.4|
74026143|NCT03191786|147605450|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.182|TWO_SIDED|95.0|0.7|1.07|||Log Rank|||Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.||1.07|0.70|0.182
74026144|NCT03191786|147605455|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|1.01||||0.975||95.0|0.57|1.78|||Log Rank|||Time to deterioration for Dyspnoea (single item QLQ-C30)||1.78|0.57|0.975
73857509|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.685|TWO_SIDED|95.0|-0.068|0.103|||Mixed Models Analysis|||Week 4||0.103|-0.068|0.685
73857510|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.176|TWO_SIDED|95.0|-0.026|0.144|||Mixed Models Analysis|||Week 4||0.144|-0.026|0.176
73857511|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.098||||0.024|TWO_SIDED|95.0|0.013|0.183|||Mixed Models Analysis|||Week 4||0.183|0.013|0.024
73857512|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.106||||0.014|TWO_SIDED|95.0|0.021|0.191|||Mixed Models Analysis|||Week 4||0.191|0.021|0.014
73857513|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.006|TWO_SIDED|95.0|0.032|0.196|||Mixed Models Analysis|||Week 4||0.196|0.032|0.006
73857514|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.165|||<|0.001|TWO_SIDED|95.0|0.081|0.249|||Mixed Models Analysis|||Week 4||0.249|0.081|< 0.001
73857515|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.707|TWO_SIDED|95.0|-0.072|0.106|||Mixed Models Analysis|||Week 8||0.106|-0.072|0.707
73857516|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.005||||0.904|TWO_SIDED|95.0|-0.083|0.094|||Mixed Models Analysis|||Week 8||0.094|-0.083|0.904
73857517|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.121|TWO_SIDED|95.0|-0.018|0.157|||Mixed Models Analysis|||Week 8||0.157|-0.018|0.121
73857518|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.026|TWO_SIDED|95.0|0.012|0.188|||Mixed Models Analysis|||Week 8||0.188|0.012|0.026
73857519|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.139||||0.001|TWO_SIDED|95.0|0.055|0.224|||Mixed Models Analysis|||Week 8||0.224|0.055|0.001
73857520|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.122||||0.006|TWO_SIDED|95.0|0.035|0.209|||Mixed Models Analysis|||Week 8||0.209|0.035|0.006
73857521|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.856|TWO_SIDED|95.0|-0.068|0.081|||Mixed Models Analysis|||Treatment period average||0.081|-0.068|0.856
73857522|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.832|TWO_SIDED|95.0|-0.066|0.082|||Mixed Models Analysis|||Treatment period average||0.082|-0.066|0.832
73857523|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.06|TWO_SIDED|95.0|-0.003|0.145|||Mixed Models Analysis|||Treatment period average||0.145|-0.003|0.060
73857524|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.096||||0.011|TWO_SIDED|95.0|0.022|0.17|||Mixed Models Analysis|||Treatment period average||0.170|0.022|0.011
73857525|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.003|TWO_SIDED|95.0|0.039|0.181|||Mixed Models Analysis|||Treatment period average||0.181|0.039|0.003
73857526|NCT03622112|147260431|SUPERIORITY||Mean Difference (Final Values)|0.129|||<|0.001|TWO_SIDED|95.0|0.055|0.202|||Mixed Models Analysis|||Treatment period average||0.202|0.055|<0.001
73964602|NCT03397108|147464771|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||Milk levels of TNF-dependent chemokine, MCP1, at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control and the 2 IBD subgroups. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including MCP1. Nonparametric comparison of the 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test.||||0.12
73964603|NCT03397108|147464771|SUPERIORITY|||||||0.051|||||||Kruskal-Wallis|||"Milk MIP-1beta at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including MIP-1beta. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.051
74026145|NCT03191786|147605455|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.89||||0.62|TWO_SIDED|95.0|0.55|1.42|||Log Rank|||Time to deterioration for Fatigue (multi items QLQ-C30)||1.42|0.55|0.620
74026146|NCT03191786|147605456|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|1.16||||0.653|TWO_SIDED|95.0|0.6|2.26|||Log Rank|||Time to deterioration for Cough (single item QLQ-LC13)||2.26|0.60|0.653
74026147|NCT03191786|147605456|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.51||||0.036|TWO_SIDED|95.0|0.27|0.97|||Log Rank|||Time to deterioration for Chest pain (single item QLQ-LC13)||0.97|0.27|0.036
74026148|NCT03191786|147605456|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.7||||0.125|TWO_SIDED|95.0|0.45|1.11|||Log Rank|||Time to deterioration for Dyspnoea (multiple items QLQ-LC13)||1.11|0.45|0.125
74026149|NCT03191786|147605456|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.75||||0.362|TWO_SIDED|95.0|0.41|1.39|||Log Rank|||Time to deterioration for Arm and/or shoulder pain (single item QLQ-LC13)||1.39|0.41|0.362
74026150|NCT03191786|147605456|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.68||||0.041|TWO_SIDED|95.0|0.46|0.99|||Log Rank|||Time to Confirmed Deterioration for the Composite of the 3 following symptoms: cough, dyspnoea (multi-items QLQ-LC13) and chest pain||0.99|0.46|0.041
74026151|NCT03191786|147605457|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.84||||0.272|TWO_SIDED|95.0|0.61|1.15|||Log Rank|||SP263 TC\>=1%||1.15|0.61|0.272
74026152|NCT03191786|147605458|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.87||||0.366|TWO_SIDED|95.0|0.64|1.18|||Log Rank|||SP263 TC\>=1%||1.18|0.64|0.366
73857527|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.936||||0.322|TWO_SIDED|95.0|0.822|1.067|||Mixed Models Analysis|||Week 2||1.067|0.822|0.322
73857528|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.876||||0.047|TWO_SIDED|95.0|0.768|0.999|||Mixed Models Analysis|||Week 2||0.999|0.768|0.047
73857529|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.842||||0.01|TWO_SIDED|95.0|0.739|0.959|||Mixed Models Analysis|||Week 2||0.959|0.739|0.010
73857530|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.825||||0.004|TWO_SIDED|95.0|0.724|0.941|||Mixed Models Analysis|||Week 2||0.941|0.724|0.004
73857531|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.687|||<|0.001|TWO_SIDED|95.0|0.606|0.779|||Mixed Models Analysis|||Week 2||0.779|0.606|<0.001
73857532|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.63|||<|0.001|TWO_SIDED|95.0|0.553|0.719|||Mixed Models Analysis|||Week 2||0.719|0.553|<0.001
73857533|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.931||||0.329|TWO_SIDED|95.0|0.805|1.076|||Mixed Models Analysis|||Week 4||1.076|0.805|0.329
73857534|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.911||||0.203|TWO_SIDED|95.0|0.789|1.052|||Mixed Models Analysis|||Week 4||1.052|0.789|0.203
73857535|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.923||||0.273|TWO_SIDED|95.0|0.8|1.065|||Mixed Models Analysis|||Week 4||1.065|0.800|0.273
73857536|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.846||||0.023|TWO_SIDED|95.0|0.734|0.977|||Mixed Models Analysis|||Week 4||0.977|0.734|0.023
73857537|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.742|||<|0.001|TWO_SIDED|95.0|0.646|0.852|||Mixed Models Analysis|||Week 4||0.852|0.646|<0.001
73857538|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.703|||<|0.001|TWO_SIDED|95.0|0.609|0.81|||Mixed Models Analysis|||Week 4||0.810|0.609|<0.001
73857539|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.917||||0.283|TWO_SIDED|95.0|0.783|1.074|||Mixed Models Analysis|||Week 8||1.074|0.783|0.283
73857540|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.933||||0.386|TWO_SIDED|95.0|0.797|1.092|||Mixed Models Analysis|||Week 8||1.092|0.797|0.386
73857541|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.886||||0.126|TWO_SIDED|95.0|0.758|1.035|||Mixed Models Analysis|||Week 8||1.035|0.758|0.126
73857542|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.855||||0.05|TWO_SIDED|95.0|0.731|1.0|||Mixed Models Analysis|||Week 8||1.000|0.731|0.050
73857543|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.723|||<|0.001|TWO_SIDED|95.0|0.623|0.84|||Mixed Models Analysis|||Week 8||0.840|0.623|<0.001
73857544|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.642|||<|0.001|TWO_SIDED|95.0|0.55|0.749|||Mixed Models Analysis|||Week 8||0.749|0.550|<0.001
73857545|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.927||||0.359|TWO_SIDED|95.0|0.789|1.09|||Mixed Models Analysis|||Week 12||1.090|0.789|0.359
73908667|NCT02484690|147347266|SUPERIORITY||Difference in Least Squares Means|1.08||||0.8406|TWO_SIDED|80.0|-5.79|7.95||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||7.95|-5.79|0.8406
73908668|NCT02484690|147347267|SUPERIORITY||Difference in Percentage of Participants|-0.77||||1|TWO_SIDED|80.0|-11.23|9.68||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||9.68|-11.23|1.0000
73908669|NCT02484690|147347268|SUPERIORITY||Difference in Least Squares Means|12.65||||0.3798|TWO_SIDED|80.0|-5.81|31.11||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||31.11|-5.81|0.3798
73908670|NCT02484690|147347268|SUPERIORITY||Difference in Least Squares Means|0.88||||0.9529|TWO_SIDED|80.0|-18.3|20.03||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||20.03|-18.3|0.9529
73908671|NCT02484690|147347268|SUPERIORITY||Difference in Least Squares Means|32.81||||0.0208|TWO_SIDED|80.0|14.65|50.96||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||50.96|14.65|0.0208
73964604|NCT03397108|147464771|SUPERIORITY|||||||0.0046|||||||Kruskal-Wallis|||"Milk IP10 at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including IP10. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.0046
73964605|NCT03397108|147464771|SUPERIORITY|||||||0.35||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Comparison of milk TNF level at the MID LACTATION POINT between non-IBD control and IBD group. The same analytical framework as the early lactation, but this is based on data at the mid-lactation point (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.35
73964606|NCT03397108|147464771|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||"Milk TNF at MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. Hypothesis is the same as for the early lactation point. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.11
73964607|NCT03397108|147464771|SUPERIORITY|||||||0.26||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MCP1 level comparison between non-IBD control and IBD group at the MID LACTATION POINT(13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.26
73964608|NCT03397108|147464771|SUPERIORITY|||||||0.15||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MIP-1beta level comparison between non-IBD control and IBD group at the MID LACTATION POINT (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.15
73964609|NCT03397108|147464771|SUPERIORITY|||||||0.31||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk IP10 level comparison between non-IBD control and IBD group at the MID LACTATION POINT (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.31
73964610|NCT03397108|147464771|SUPERIORITY|||||||0.21|||||||Kruskal-Wallis|||"Milk MCP-1 at the MID LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The hypothesis is the same as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.21
73964611|NCT03397108|147464771|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||"Milk MIP-1beta at the MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The hypothesis is the same as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.12
74029777|NCT03151148|147614041|SUPERIORITY||Geometric mean ratio (GMR)|0.615||||0.702|TWO_SIDED|95.0|0.0503|7.5106|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.5106|0.0503|0.702
74026153|NCT02517515|147605474|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment (SVR12) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||TWO_SIDED|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-naïve group, the sample size 180 treatment-naïve participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||99.9|97.0|
73857546|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.953||||0.556|TWO_SIDED|95.0|0.813|1.118|||Mixed Models Analysis|||Week 12||1.118|0.813|0.556
73857547|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.869||||0.084|TWO_SIDED|95.0|0.742|1.019|||Mixed Models Analysis|||Week 12||1.019|0.742|0.084
73857548|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.813||||0.011|TWO_SIDED|95.0|0.693|0.953|||Mixed Models Analysis|||Week 12||0.953|0.693|0.011
73857549|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.65|||<|0.001|TWO_SIDED|95.0|0.559|0.757|||Mixed Models Analysis|||Week 12||0.757|0.559|<0.001
73857550|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.623|||<|0.001|TWO_SIDED|95.0|0.533|0.729|||Mixed Models Analysis|||Week 12||0.729|0.533|<0.001
73857551|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.928||||0.231|TWO_SIDED|95.0|0.821|1.049|||Mixed Models Analysis|||Treatment period average||1.049|0.821|0.231
73857552|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.918||||0.17|TWO_SIDED|95.0|0.812|1.037|||Mixed Models Analysis|||Treatment period average||1.037|0.812|0.170
73857553|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.879||||0.039|TWO_SIDED|95.0|0.778|0.994|||Mixed Models Analysis|||Treatment period average||0.994|0.778|0.039
73857554|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.835||||0.004|TWO_SIDED|95.0|0.739|0.943|||Mixed Models Analysis|||Treatment period average||0.943|0.739|0.004
73857555|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.7|||<|0.001|TWO_SIDED|95.0|0.622|0.787|||Mixed Models Analysis|||Treatment period average||0.787|0.622|<0.001
73857556|NCT03622112|147260432|SUPERIORITY||Mean Difference (Final Values)|0.649|||<|0.001|TWO_SIDED|95.0|0.575|0.732|||Mixed Models Analysis|||Treatment period average||0.732|0.575|<0.001
73857557|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|-0.034||||0.519|TWO_SIDED|95.0|-0.139|0.07|||Mixed Models Analysis|||Week 12||0.070|-0.139|0.519
73857558|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|-0.078||||0.141|TWO_SIDED|95.0|-0.181|0.026|||Mixed Models Analysis|||Week 12||0.026|-0.181|0.141
73857559|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.772|TWO_SIDED|95.0|-0.088|0.119|||Mixed Models Analysis|||Week 12||0.119|-0.088|0.772
73857560|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.27|TWO_SIDED|95.0|-0.045|0.162|||Mixed Models Analysis|||Week 12||0.162|-0.045|0.270
73857561|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.592|TWO_SIDED|95.0|-0.072|0.126|||Mixed Models Analysis|||Week 12||0.126|-0.072|0.592
73857562|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.275|TWO_SIDED|95.0|-0.045|0.158|||Mixed Models Analysis|||Week 12||0.158|-0.045|0.275
73857563|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.963|TWO_SIDED|95.0|-0.087|0.083|||Mixed Models Analysis|||Treatment period average||0.083|-0.087|0.963
73857564|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|-0.027||||0.533|TWO_SIDED|95.0|-0.112|0.058|||Mixed Models Analysis|||Treatment period average||0.058|-0.112|0.533
73857565|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.342|TWO_SIDED|95.0|-0.044|0.126|||Mixed Models Analysis|||Treatment period average||0.126|-0.044|0.342
73857566|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|0.081||||0.061|TWO_SIDED|95.0|-0.004|0.165|||Mixed Models Analysis|||Treatment period average||0.165|-0.004|0.061
73857567|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.278|TWO_SIDED|95.0|-0.037|0.127|||Mixed Models Analysis|||Treatment period average||0.127|-0.037|0.278
73857568|NCT03622112|147260433|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.079|TWO_SIDED|95.0|-0.009|0.159|||Mixed Models Analysis|||Treatment period average||0.159|-0.009|0.079
73857569|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.153||||0.088|TWO_SIDED|95.0|-0.328|0.023|||Mixed Models Analysis|||Week 12||0.023|-0.328|0.088
73857570|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.257||||0.004|TWO_SIDED|95.0|-0.43|-0.084|||Mixed Models Analysis|||Week 12||-0.084|-0.430|0.004
73857571|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.221||||0.012|TWO_SIDED|95.0|-0.393|-0.049|||Mixed Models Analysis|||Week 12||-0.049|-0.393|0.012
73857572|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.193||||0.029|TWO_SIDED|95.0|-0.366|-0.02|||Mixed Models Analysis|||Week 12||-0.020|-0.366|0.029
73857573|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.269||||0.001|TWO_SIDED|95.0|-0.434|-0.104|||Mixed Models Analysis|||Week 12||-0.104|-0.434|0.001
73857574|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.223||||0.01|TWO_SIDED|95.0|-0.393|-0.054|||Mixed Models Analysis|||Week 12||-0.054|-0.393|0.010
73857575|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.125||||0.055|TWO_SIDED|95.0|-0.253|0.003|||Mixed Models Analysis|||Treatment period average||0.003|-0.253|0.055
73857576|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.141||||0.029|TWO_SIDED|95.0|-0.268|-0.014|||Mixed Models Analysis|||Treatment period average||-0.014|-0.268|0.029
73857577|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.044|TWO_SIDED|95.0|-0.257|-0.003|||Mixed Models Analysis|||Treatment period average||-0.003|-0.257|0.044
73964612|NCT03397108|147464771|SUPERIORITY|||||||0.29|||||||Kruskal-Wallis|||"Milk IP10 at the MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The same hypothesis as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.29
73964613|NCT03397108|147464771|OTHER|Correlation analysis|Spearman rank correlation|0.7232|||<|0.0001|TWO_SIDED|95.0|0.5647|0.8303||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine MCP1 to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine MCP1.||0.8303|0.5647|<0.0001
73964614|NCT03397108|147464771|OTHER|Correlation analysis|Spearman rank correlation|0.6835|||<|0.0001|TWO_SIDED|95.0|0.5088|0.8042||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine MIP-1beta to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine MIP-1beta.||0.8042|0.5088|<0.0001
73964615|NCT03397108|147464771|OTHER|Correlation analysis|Spearman rank correlation|0.6316|||<|0.0001|TWO_SIDED|95.0|0.4377|0.7693||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine IP10 to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine IP10.||0.7693|0.4377|<0.0001
73964616|NCT03397108|147464771|OTHER|Correlation analysis|Spearman rank correlation|0.572|||<|0.0001|TWO_SIDED|95.0|0.3445|0.736||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and MCP1 to see of they are positively correlated.||0.7360|0.3445|<0.0001
74026154|NCT02517515|147605474|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment for the treatment-experienced participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|percentage of participants|100.0|||||TWO_SIDED|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||100.0|97.4|
74085221|NCT00513617|147724091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1826|STANDARD_ERROR_OF_MEAN|0.0713||0.915||||||Alpha was set at 0.5|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.915
73857578|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.201||||0.002|TWO_SIDED|95.0|-0.328|-0.074|||Mixed Models Analysis|||Treatment period average||-0.074|-0.328|0.002
73857579|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.217|||<|0.001|TWO_SIDED|95.0|-0.339|-0.094|||Mixed Models Analysis|||Treatment period average||-0.094|-0.339|<0.001
73857580|NCT03622112|147260434|SUPERIORITY||Mean Difference (Final Values)|-0.179||||0.005|TWO_SIDED|95.0|-0.305|-0.053|||Mixed Models Analysis|||Treatment period average||-0.053|-0.305|0.005
73857581|NCT03622112|147260435|SUPERIORITY||Mean Difference (Final Values)|7.664||||0.097|TWO_SIDED|95.0|-1.403|16.73|||Mixed Models Analysis|||Treatment period average||16.730|-1.403|0.097
73857582|NCT03622112|147260435|SUPERIORITY||Mean Difference (Final Values)|5.981||||0.19|TWO_SIDED|95.0|-2.98|14.941|||Mixed Models Analysis|||Treatment period average||14.941|-2.980|0.190
73857583|NCT03622112|147260435|SUPERIORITY||Mean Difference (Final Values)|9.123||||0.045|TWO_SIDED|95.0|0.195|18.052|||Mixed Models Analysis|||Treatment period average||18.052|0.195|0.045
73857584|NCT03622112|147260435|SUPERIORITY||Mean Difference (Final Values)|15.444|||<|0.001|TWO_SIDED|95.0|6.443|24.445|||Mixed Models Analysis|||Treatment period average||24.445|6.443|<0.001
73857585|NCT03622112|147260435|SUPERIORITY||Mean Difference (Final Values)|16.599|||<|0.001|TWO_SIDED|95.0|8.031|25.167|||Mixed Models Analysis|||Treatment period average||25.167|8.031|<0.001
73857586|NCT03622112|147260435|SUPERIORITY||Mean Difference (Final Values)|10.491||||0.019|TWO_SIDED|95.0|1.726|19.256|||Mixed Models Analysis|||Treatment period average||19.256|1.726|0.019
73857587|NCT03622112|147260436|SUPERIORITY||Mean Difference (Final Values)|2.398||||0.597|TWO_SIDED|95.0|-6.494|11.29|||Mixed Models Analysis|||Treatment period average||11.290|-6.494|0.597
73857588|NCT03622112|147260436|SUPERIORITY||Mean Difference (Final Values)|2.162||||0.629|TWO_SIDED|95.0|-6.623|10.948|||Mixed Models Analysis|||Treatment period average||10.948|-6.623|0.629
73857589|NCT03622112|147260436|SUPERIORITY||Mean Difference (Final Values)|3.833||||0.389|TWO_SIDED|95.0|-4.907|12.573|||Mixed Models Analysis|||Treatment period average||12.573|-4.907|0.389
73857590|NCT03622112|147260436|SUPERIORITY||Mean Difference (Final Values)|10.258||||0.022|TWO_SIDED|95.0|1.456|19.059|||Mixed Models Analysis|||Treatment period average||19.059|1.456|0.022
73857591|NCT03622112|147260436|SUPERIORITY||Mean Difference (Final Values)|11.994||||0.005|TWO_SIDED|95.0|3.571|20.417|||Mixed Models Analysis|||Treatment period average||20.417|3.571|0.005
73857592|NCT03622112|147260436|SUPERIORITY||Mean Difference (Final Values)|6.129||||0.163|TWO_SIDED|95.0|-2.479|14.737|||Mixed Models Analysis|||Treatment period average||14.737|-2.479|0.163
73857593|NCT03622112|147260437|SUPERIORITY||Mean Difference (Final Values)|-0.243||||0.012|TWO_SIDED|95.0|-0.431|-0.054|||Mixed Models Analysis|||Treatment period average||-0.054|-0.431|0.012
73857594|NCT03622112|147260437|SUPERIORITY||Mean Difference (Final Values)|-0.155||||0.108|TWO_SIDED|95.0|-0.344|0.034|||Mixed Models Analysis|||Treatment period average||0.034|-0.344|0.108
73857595|NCT03622112|147260437|SUPERIORITY||Mean Difference (Final Values)|-0.099||||0.295|TWO_SIDED|95.0|-0.286|0.087|||Mixed Models Analysis|||Treatment period average||0.087|-0.286|0.295
73908672|NCT02484690|147347269|SUPERIORITY||Difference in Least Squares Means|-6.35||||0.5185|TWO_SIDED|80.0|-19.0|6.27||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||6.27|-19.0|0.5185
73908673|NCT02484690|147347270|SUPERIORITY||Difference in Least Squares Means|19.45||||0.1624|TWO_SIDED|80.0|1.61|37.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||37.29|1.61|0.1624
73908674|NCT02484690|147347270|SUPERIORITY||Difference in Least Squares Means|2.79||||0.8475|TWO_SIDED|80.0|-15.8|21.37||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||21.37|-15.8|0.8475
73908675|NCT02484690|147347270|SUPERIORITY||Difference in Least Squares Means|28.52||||0.0381|TWO_SIDED|80.0|10.93|46.11||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||46.11|10.93|0.0381
73964617|NCT03397108|147464771|OTHER|Correlation analysis|Spearman rank correlation|0.7564|||<|0.0001|TWO_SIDED|95.0|0.6022|0.8562||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and MIP-1beta to see of they are positively correlated.||0.8562|0.6022|<0.0001
73964618|NCT03397108|147464771|OTHER|Correlation analysis|Spearman rank correlation|0.32||||0.0227|TWO_SIDED|95.0|0.03869|0.552||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and IP10 to see of they are positively correlated.||0.5520|0.03869|0.0227
73964619|NCT03397108|147464771|OTHER|Correlation analysis|Spearman rank correlation|0.52||||0.0001|TWO_SIDED|95.0|0.2727|0.6975||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk TNF between early and mid-lactation points.||0.6975|0.2727|0.0001
73964620|NCT03397108|147464771|OTHER|Correlation analysis|Spearman rank correlation|0.4722||||0.0005|TWO_SIDED|95.0|0.2181|0.6664||Not adjusted for multiple comparison.|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk MCP1 between early and mid-lactation points.||0.6664|0.2181|0.0005
73857596|NCT03622112|147260437|SUPERIORITY||Mean Difference (Final Values)|-0.308||||0.002|TWO_SIDED|95.0|-0.5|-0.116|||Mixed Models Analysis|||Treatment period average||-0.116|-0.500|0.002
73857597|NCT03622112|147260437|SUPERIORITY||Mean Difference (Final Values)|-0.308|||<|0.001|TWO_SIDED|95.0|-0.489|-0.126|||Mixed Models Analysis|||Treatment period average||-0.126|-0.489|<0.001
73857598|NCT03622112|147260437|SUPERIORITY||Mean Difference (Final Values)|-0.177||||0.062|TWO_SIDED|95.0|-0.362|0.009|||Mixed Models Analysis|||Treatment period average||0.009|-0.362|0.062
73908676|NCT02484690|147347271|SUPERIORITY||Difference in Least Squares Means|-14.4||||0.2089|TWO_SIDED|80.0|-29.1|0.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||0.29|-29.1|0.2089
73964621|NCT03397108|147464771|OTHER|Correlation analysis|Spearman rank correlation|0.36||||0.01|TWO_SIDED|95.0|0.0802|0.5803||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk MIP-1beta between early and mid-lactation points.||0.5803|0.0802|0.01
73857599|NCT03622112|147260438|SUPERIORITY||Mean Difference (Final Values)|-9.993|||<|0.001|TWO_SIDED|95.0|-15.795|-4.191|||Mixed Models Analysis|||Treatment period average||-4.191|-15.795|<0.001
73857600|NCT03622112|147260438|SUPERIORITY||Mean Difference (Final Values)|-7.972||||0.006|TWO_SIDED|95.0|-13.694|-2.251|||Mixed Models Analysis|||Treatment period average||-2.251|-13.694|0.006
73857601|NCT03622112|147260438|SUPERIORITY||Mean Difference (Final Values)|-4.361||||0.133|TWO_SIDED|95.0|-10.051|1.329|||Mixed Models Analysis|||Treatment period average||1.329|-10.051|0.133
73857602|NCT03622112|147260438|SUPERIORITY||Mean Difference (Final Values)|-7.797||||0.008|TWO_SIDED|95.0|-13.555|-2.04|||Mixed Models Analysis|||Treatment period average||-2.040|-13.555|0.008
73857603|NCT03622112|147260438|SUPERIORITY||Mean Difference (Final Values)|-8.729||||0.002|TWO_SIDED|95.0|-14.195|-3.264|||Mixed Models Analysis|||Treatment period average||-3.264|-14.195|0.002
73857604|NCT03622112|147260438|SUPERIORITY||Mean Difference (Final Values)|-11.622|||<|0.001|TWO_SIDED|95.0|-17.211|-6.034|||Mixed Models Analysis|||Treatment period average||-6.034|-17.211|<0.001
73857605|NCT03622112|147260439|SUPERIORITY||Mean Difference (Final Values)|-0.212|||<|0.001|TWO_SIDED|95.0|-0.329|-0.094|||Mixed Models Analysis|||Treatment period average||-0.094|-0.329|<0.001
74026155|NCT02517515|147605475|SUPERIORITY|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR24 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||TWO_SIDED|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||99.9|97.0|
74026156|NCT02517515|147605475|SUPERIORITY|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-experienced participants in the double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with SVR24 must exceed 75% to achieve superiority.|percentage of participants|100.0|||||TWO_SIDED|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||100.0|97.4|
73857606|NCT03622112|147260439|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.066|TWO_SIDED|95.0|-0.228|0.007|||Mixed Models Analysis|||Treatment period average||0.007|-0.228|0.066
73857607|NCT03622112|147260439|SUPERIORITY||Mean Difference (Final Values)|-0.139||||0.02|TWO_SIDED|95.0|-0.255|-0.022|||Mixed Models Analysis|||Treatment period average||-0.022|-0.255|0.020
73857608|NCT03622112|147260439|SUPERIORITY||Mean Difference (Final Values)|-0.23|||<|0.001|TWO_SIDED|95.0|-0.35|-0.11|||Mixed Models Analysis|||Treatment period average||-0.110|-0.350|<0.001
73857609|NCT03622112|147260439|SUPERIORITY||Mean Difference (Final Values)|-0.185||||0.001|TWO_SIDED|95.0|-0.298|-0.071|||Mixed Models Analysis|||Treatment period average||-0.071|-0.298|0.001
73857610|NCT03622112|147260439|SUPERIORITY||Mean Difference (Final Values)|-0.206|||<|0.001|TWO_SIDED|95.0|-0.321|-0.09|||Mixed Models Analysis|||Treatment period average||-0.090|-0.321|<0.001
73857611|NCT03622112|147260440|SUPERIORITY||Mean Difference (Final Values)|9.611||||0.026|TWO_SIDED|95.0|1.18|18.042|||Mixed Models Analysis|||Treatment period average||18.042|1.180|0.026
73857612|NCT03622112|147260440|SUPERIORITY||Mean Difference (Final Values)|5.503||||0.2|TWO_SIDED|95.0|-2.927|13.933|||Mixed Models Analysis|||Treatment period average||13.933|-2.927|0.200
73908677|NCT02484690|147347274|SUPERIORITY||Difference in Least Squares Means|-0.4||||0.6717|TWO_SIDED|80.0|-1.61|0.81||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.81|-1.61|0.6717
73857613|NCT03622112|147260440|SUPERIORITY||Mean Difference (Final Values)|6.787||||0.11|TWO_SIDED|95.0|-1.546|15.119|||Mixed Models Analysis|||Treatment period average||15.119|-1.546|0.110
73857614|NCT03622112|147260440|SUPERIORITY||Mean Difference (Final Values)|10.066||||0.022|TWO_SIDED|95.0|1.461|18.672|||Mixed Models Analysis|||Treatment period average||18.672|1.461|0.022
73857615|NCT03622112|147260440|SUPERIORITY||Mean Difference (Final Values)|8.62||||0.038|TWO_SIDED|95.0|0.489|16.75|||Mixed Models Analysis|||Treatment period average||16.750|0.489|0.038
73857616|NCT03622112|147260440|SUPERIORITY||Mean Difference (Final Values)|7.178||||0.09|TWO_SIDED|95.0|-1.112|15.467|||Mixed Models Analysis|||Treatment period average||15.467|-1.112|0.090
73857617|NCT03622112|147260441|SUPERIORITY||Mean Difference (Final Values)|7.936||||0.123|TWO_SIDED|95.0|-2.16|18.031|||Mixed Models Analysis|||Treatment period average||18.031|-2.160|0.123
73857618|NCT03622112|147260441|SUPERIORITY||Mean Difference (Final Values)|0.977||||0.849|TWO_SIDED|95.0|-9.112|11.065|||Mixed Models Analysis|||Treatment period average||11.065|-9.112|0.849
73857619|NCT03622112|147260441|SUPERIORITY||Mean Difference (Final Values)|-1.242||||0.807|TWO_SIDED|95.0|-11.233|8.748|||Mixed Models Analysis|||Treatment period average||8.748|-11.233|0.807
73857620|NCT03622112|147260441|SUPERIORITY||Mean Difference (Final Values)|11.789||||0.025|TWO_SIDED|95.0|1.488|22.09|||Mixed Models Analysis|||Treatment period average||22.090|1.488|0.025
73857621|NCT03622112|147260441|SUPERIORITY||Mean Difference (Final Values)|7.574||||0.127|TWO_SIDED|95.0|-2.16|17.307|||Mixed Models Analysis|||Treatment period average||17.307|-2.160|0.127
73857622|NCT03622112|147260441|SUPERIORITY||Mean Difference (Final Values)|5.058||||0.318|TWO_SIDED|95.0|-4.874|14.99|||Mixed Models Analysis|||Treatment period average||14.990|-4.874|0.318
73857623|NCT03622112|147260442|SUPERIORITY||Mean Difference (Final Values)|10.45||||0.015|TWO_SIDED|95.0|2.046|18.855|||Mixed Models Analysis|||Treatment period average||18.855|2.046|0.015
73857624|NCT03622112|147260442|SUPERIORITY||Mean Difference (Final Values)|7.192||||0.093|TWO_SIDED|95.0|-1.208|15.592|||Mixed Models Analysis|||Treatment period average||15.592|-1.208|0.093
73857625|NCT03622112|147260442|SUPERIORITY||Mean Difference (Final Values)|8.606||||0.042|TWO_SIDED|95.0|0.298|16.913|||Mixed Models Analysis|||Treatment period average||16.913|0.298|0.042
73857626|NCT03622112|147260442|SUPERIORITY||Mean Difference (Final Values)|11.344||||0.01|TWO_SIDED|95.0|2.773|19.914|||Mixed Models Analysis|||Treatment period average||19.914|2.773|0.010
73857627|NCT03622112|147260442|SUPERIORITY||Mean Difference (Final Values)|10.122||||0.014|TWO_SIDED|95.0|2.021|18.222|||Mixed Models Analysis|||Treatment period average||18.222|2.021|0.014
73857628|NCT03622112|147260442|SUPERIORITY||Mean Difference (Final Values)|10.689||||0.011|TWO_SIDED|95.0|2.424|18.953|||Mixed Models Analysis|||Treatment period average||18.953|2.424|0.011
73857629|NCT03622112|147260453|SUPERIORITY||geometric LSMean ratio|1.01||||0.909|TWO_SIDED|95.0|0.851|1.199|||Mixed Models Analysis|||||1.199|0.851|0.909
73857630|NCT03622112|147260453|SUPERIORITY||geometric LSMean ratio|1.118||||0.218|TWO_SIDED|95.0|0.935|1.336|||Mixed Models Analysis|||||1.336|0.935|0.218
73908678|NCT02484690|147347274|SUPERIORITY||Difference in Least Squares Means|0.23||||0.8131|TWO_SIDED|80.0|-1.01|1.47||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||1.47|-1.01|0.8131
73908679|NCT02484690|147347274|SUPERIORITY||Difference in Least Squares Means|0.11||||0.9069|TWO_SIDED|80.0|-1.07|1.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between each of the treatment groups (Arms B, C, or D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arms B, C, or D means were different from Arm A mean.||1.29|-1.07|0.9069
73908680|NCT02484690|147347276|SUPERIORITY||Difference in Least Squares Means|-0.96||||0.3189|TWO_SIDED|80.0|-2.2|0.28||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.28|-2.20|0.3189
73908681|NCT02484690|147347276|SUPERIORITY||Difference in Least Squares Means|1.22||||0.2256|TWO_SIDED|80.0|-0.07|2.52||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.52|-0.07|0.2256
73908682|NCT02484690|147347276|SUPERIORITY||Difference in Least Squares Means|0.35||||0.7086|TWO_SIDED|80.0|-0.86|1.57||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.57|-0.86|0.7086
73908683|NCT02484690|147347278|SUPERIORITY||Difference in Least Squares Means|-0.78||||0.4353|TWO_SIDED|80.0|-2.07|0.51||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.51|-2.07|0.4353
74026157|NCT02786537|147605503|SUPERIORITY|Superiority test derived by comparing whether the 95% CI includes zero.|Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-3.6|0.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|PROD vs. SOF/LDV based regimens as reported in PRO (ALL PATIENTS WHO STARTED TREATMENT BY ARM AS TREATED), population limited to as randomization date of the last PrOD patient start date - RBV FREE REGIMENS||0.3|-3.6|
74026158|NCT02786537|147605503|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-0.4|3.1|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method. CI for median derived from PROC QUANTREG.|RBV free EBR/GZR regimen compared to PrOD in consideration that RBV usage was determined by provider and not study randomization.||3.1|-0.4|
74026159|NCT02786537|147605504|SUPERIORITY|Superiority test completed by comparing whether the 95% CI includes zero.|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.6|1.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|Analysis based on RBV free EBR/GZR regimen vs SOF/LDV (all patients who started treatment by arm as treated)||1.0|-0.6|
74026160|NCT02786537|147605506|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|0.0|1.0|||||The comparisons between regimens can be viewed as superiority test, by comparing whether the 95% CI includes zero|Analysis of EBR/GZR vs. SOF/LDV irrespective of RBV usage in consideration that RBV usage was determined by provider and not study randomization.||1.0|0.0|
73930950|NCT00280566|147391712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.22||0.9538|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9538
73930951|NCT00280566|147391712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.25||0.8541|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8541
74026161|NCT02786537|147605507|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-4.2|7.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis based on RBV free SOF/LDV vs. PrOD in consideration that RBV usage was determined by provider and not study randomization and limited RBV sample size.||7.0|-4.2|
73908684|NCT02484690|147347278|SUPERIORITY||Difference in Least Squares Means|1.45||||0.1652|TWO_SIDED|80.0|0.11|2.78||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.78|0.11|0.1652
73908685|NCT02484690|147347278|SUPERIORITY||Difference in Least Squares Means|0.5||||0.61111|TWO_SIDED|80.0|-0.76|1.75||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.75|-0.76|0.61111
73908686|NCT04916769|147347318|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of ajusted geometric means|106.27|||||TWO_SIDED|90.0|97.76|115.53||||||Natural logarithm-transformed bosutinib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% confidence intervals (CIs) were obtained from the model.||115.53|97.76|
73908687|NCT04916769|147347318|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|101.93|||||TWO_SIDED|90.0|93.97|110.56||||||Natural logarithm-transformed bosutinib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||110.56|93.97|
73908688|NCT04916769|147347319|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|96.82|||||TWO_SIDED|90.0|86.37|108.53||||||Natural logarithm-transformed bosutinib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||108.53|86.37|
73908689|NCT04916769|147347319|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|95.39|||||TWO_SIDED|90.0|85.34|106.61||||||Natural logarithm-transformed bosutinib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||106.61|85.34|
73908690|NCT04916769|147347320|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|106.23|||||TWO_SIDED|90.0|97.54|115.68||||||Natural logarithm-transformed bosutinib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||115.68|97.54|
73908691|NCT04916769|147347320|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|102.08|||||TWO_SIDED|90.0|93.95|110.91||||||Natural logarithm-transformed bosutinib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||110.91|93.95|
73908692|NCT03507400|147347357|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
73908693|NCT03507400|147347357|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||pooled comparison of the participants of the non-waiting list and the waiting list before and after Introvision||||0.003
73908694|NCT03507400|147347359|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73908695|NCT03507400|147347360|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.003
73908696|NCT03507400|147347361|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.001
73908697|NCT03507400|147347362|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.001
73908698|NCT03507400|147347366|SUPERIORITY|Wilcoxon paired test||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
73857631|NCT03622112|147260453|SUPERIORITY||geometric LSMean ratio|1.129||||0.181|TWO_SIDED|95.0|0.944|1.349|||Mixed Models Analysis|||||1.349|0.944|0.181
73857632|NCT03622112|147260453|SUPERIORITY||geometric LSMean ratio|0.984||||0.859|TWO_SIDED|95.0|0.825|1.174|||Mixed Models Analysis|||||1.174|0.825|0.859
73857633|NCT03622112|147260453|SUPERIORITY||geometric LSMean ratio|0.916||||0.285|TWO_SIDED|95.0|0.78|1.077|||Mixed Models Analysis|||||1.077|0.780|0.285
73857634|NCT03622112|147260453|SUPERIORITY||geometric LSMean ratio|0.991||||0.923|TWO_SIDED|95.0|0.831|1.182|||Mixed Models Analysis|||||1.182|0.831|0.923
73857635|NCT00521599|147260462|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|assume n=240 per group and standard deviation (STD) = 45 L/min for AM Peak Flow Rate at Week 8. If the two actives are the same, 95% CI of their mean difference has 90% probability to be completely within +/- 15 L/min.|Mean Difference (Net)|-1.62|STANDARD_DEVIATION|37.0||0.654|TWO_SIDED|95.0|-8.74|5.49|||ANOVA|||Week 8 End scores||5.49|-8.74|0.654
73857636|NCT00521599|147260462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||ANOVA|||Week 8 End scores||||0.003
73857637|NCT00521599|147260462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANOVA|||Week 8 End scores||||0.001
73857638|NCT03119181|147260505|SUPERIORITY|||||||0.0097|||||||one-sided permutation test|||one-sided permutation test at 2.5% significance||||0.0097
73857639|NCT02379988|147260528|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions|||||=|0.0063||||||P-value for Free breathing and Breath Holding Heart Mean|Wilcoxon (Mann-Whitney)|||||||=0.0063
73857640|NCT02379988|147260528|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.011||||||P-value for Free breathing and Breath Holding Lung Mean|Wilcoxon (Mann-Whitney)|||||||=0 .0110
73857641|NCT02379988|147260528|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.5098||||||P-value for Free breathing and Breath Holding LAD Mean|Wilcoxon (Mann-Whitney)|||||||=0.5098
73908699|NCT03507400|147347366|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
73908700|NCT03507400|147347366|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
73908701|NCT01555983|147347369|SUPERIORITY_OR_OTHER||Cochran-Armitage trend tes|0.0001|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The number needed to treat (NNT) to achieve 30% pain reduction during the 8-hour period was 4 (95% CI: 2.1-25.3) for the lower dose vs. placebo, and 3 (95% CI: 1.6-4.2) for the higher dose versus placebo.||||<.05
73908702|NCT04806503|147347392|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.006|STANDARD_ERROR_OF_MEAN|0.0258||0.817|TWO_SIDED|95.0|-0.045|0.056|||Mixed-effect Model for Repeated Measures|||||0.056|-0.045|0.817
73908703|NCT04806503|147347392|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.002|STANDARD_ERROR_OF_MEAN|0.0262||0.946|TWO_SIDED|95.0|-0.05|0.053|||Mixed-effect Model for Repeated Measures|||||0.053|-0.050|0.946
73857642|NCT02379988|147260529|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions|||||=|0.001||||||P-value for Heart Max Free breathing and Breath Hold|Wilcoxon (Mann-Whitney)|||||||=0.0010
73857643|NCT02379988|147260529|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.011||||||P-value for Lung Max Free breathing and Breath Hold|Wilcoxon (Mann-Whitney)|||||||=0.0110
73857644|NCT02379988|147260530|EQUIVALENCE|Paired T-test|||||=|0.01||||||P-value for Large breast volume group|Paired T-test|||||||=0.01
73857645|NCT02379988|147260530|EQUIVALENCE|Paired T-test|||||=|0.1||||||P-value for Small breast volume group|Paired T-test|||||||=0.10
73857646|NCT02379988|147260531|EQUIVALENCE|Wilcoxon test was used due to the non-normal distribution of the data|||||=|0.7776|||||||Wilcoxon (Mann-Whitney)|||||||=0.7776
73857647|NCT02089464|147260533|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
73857648|NCT02089464|147260534|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
73857649|NCT02089464|147260535|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
73857650|NCT02089464|147260536|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
73908704|NCT04806503|147347392|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|-0.024|STANDARD_ERROR_OF_MEAN|0.027||0.38|TWO_SIDED|95.0|-0.077|0.029|||Mixed-effect Model for Repeated Measures|||||0.029|-0.077|0.380
73857651|NCT02089464|147260537|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
73857652|NCT02089464|147260539|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
73857653|NCT02089464|147260540|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
73857654|NCT02089464|147260541|SUPERIORITY|||||||0.63|||||||Chi-squared|||||||0.63
73857655|NCT00934947|147260549|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||.36
73857656|NCT00934947|147260550|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||.32
73857657|NCT00934947|147260551|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||.48
73857658|NCT01907321|147260555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.78|STANDARD_DEVIATION|14.98||0.001|TWO_SIDED||||||repeated measures ANOVA|||||||.001
73857659|NCT01907321|147260556|SUPERIORITY_OR_OTHER|||||||0.519|||||||ANOVA|||||||.519
73908705|NCT04806503|147347392|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.011|STANDARD_ERROR_OF_MEAN|0.0258||0.667|TWO_SIDED|95.0|-0.039|0.062|||Mixed-effect Model for Repeated Measures|||||0.062|-0.039|0.667
73908706|NCT04806503|147347393|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.022|STANDARD_ERROR_OF_MEAN|0.0304||0.474|TWO_SIDED|95.0|-0.038|0.081|||Mixed-effect Model for Repeated Measures|||||0.081|-0.038|0.474
73908707|NCT04806503|147347393|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.025|STANDARD_ERROR_OF_MEAN|0.0309||0.419|TWO_SIDED|95.0|-0.036|0.086|||Mixed-effect Model for Repeated Measures|||||0.086|-0.036|0.419
73908708|NCT04806503|147347393|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.003|STANDARD_ERROR_OF_MEAN|0.0322||0.914||95.0|-0.06|0.067|||Mixed-effect Model for Repeated Measures|||||0.067|-0.060|0.914
73908709|NCT04806503|147347393|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.034|STANDARD_ERROR_OF_MEAN|0.0305||0.263|TWO_SIDED|95.0|-0.026|0.094|||Mixed-effect Model for Repeated Measures|||||0.094|-0.026|0.263
73908710|NCT04806503|147347394|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.029|STANDARD_ERROR_OF_MEAN|0.0273||0.284|TWO_SIDED|95.0|-0.024|0.083|||Mixed-effect Model for Repeated Measures|||||0.083|-0.024|0.284
73908711|NCT04806503|147347394|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.01|STANDARD_ERROR_OF_MEAN|0.0278||0.711|TWO_SIDED|95.0|-0.044|0.065|||Mixed-effect Model for Repeated Measures|||||0.065|-0.044|0.711
73908712|NCT04806503|147347394|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.005|STANDARD_ERROR_OF_MEAN|0.0284||0.871|TWO_SIDED|95.0|-0.051|0.06|||Mixed-effect Model for Repeated Measures|||||0.060|-0.051|0.871
73908713|NCT04806503|147347394|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.027|STANDARD_ERROR_OF_MEAN|0.0273||0.329|TWO_SIDED|95.0|-0.027|0.08|||Mixed-effect Model for Repeated Measures|||||0.080|-0.027|0.329
73908714|NCT04806503|147347395|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.95||||0.516|TWO_SIDED|95.0|0.083|10.847|||Multiple Imputation, Logistic Regression|||||10.847|0.083|0.516
73908715|NCT04806503|147347395|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|2.45||||0.177|TWO_SIDED|95.0|0.367|16.398|||Multiple Imputation, Logistic Regression|||||16.398|0.367|0.177
73908716|NCT04806503|147347395|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|3.65||||0.079|TWO_SIDED|95.0|0.604|22.094|||Multiple Imputation, Logistic Regression|||||22.094|0.604|0.079
73964622|NCT03397108|147464771|OTHER|Correlation analysis|Spearman rank correlation|0.66|||<|0.0001|TWO_SIDED|95.0|0.467|0.7964||Not adjusted for multiple comparison|Spearman rank correlation|Spearman r = 0.66 (95%CI: 0.4670 - 0.7964). Number of XY pairs: 51||Using the pooled data of all participants, we assessed temporal tracking of milk IP10 between early and mid-lactation points.||0.7964|0.4670|<0.0001
73908717|NCT04806503|147347395|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|1.07||||0.476|TWO_SIDED|95.0|0.136|8.381|||Multiple Imputation, Logistic Regression|||||8.381|0.136|0.476
73908718|NCT04806503|147347396|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.87||||0.577|TWO_SIDED|95.0|0.201|3.726|||Multiple Imputation, Logistic Regression|||||3.726|0.201|0.577
73908719|NCT04806503|147347396|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.52||||0.804|TWO_SIDED|95.0|0.113|2.353|||Multiple Imputation, Logistic Regression|||||2.353|0.113|0.804
73908720|NCT04806503|147347396|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.34||||0.85|TWO_SIDED|95.0|0.045|2.602|||Multiple Imputation, Logistic Regression|||||2.602|0.045|0.850
73908721|NCT04806503|147347396|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.69||||0.684|TWO_SIDED|95.0|0.157|3.08|||Multiple Imputation, Logistic Regression|||||3.080|0.157|0.684
73908722|NCT04806503|147347397|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.56||||0.728|TWO_SIDED|95.0|0.089|3.593|||Multiple Imputation, Logistic Regression|||||3.593|0.089|0.728
73908723|NCT04806503|147347397|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|1.16||||0.428|TWO_SIDED|95.0|0.242|5.529|||Multiple Imputation, Logistic Regression|||||5.529|0.242|0.428
73908724|NCT04806503|147347397|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.0||||0.5|TWO_SIDED|95.0|0.0||NA when n = 1.||Multiple Imputation, Logistic Regression||||||0.000|0.500
73908725|NCT04806503|147347397|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.28||||0.851|TWO_SIDED|95.0|0.026|3.07|||Multiple Imputation, Logistic Regression|||||3.070|0.026|0.851
73908726|NCT00546104|147347436|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|9.0||0.3|TWO_SIDED|95.0|-30.0|9.0||The p-value is from a paired t-test to test the null hypothesis the mean relative change in Src from baseline to 4 weeks is equal to zero.|t-test, 2 sided|||The median change in SRC from baseline to 4 weeks was estimated.||9|-30|0.3
73908727|NCT00546104|147347437|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.3|TWO_SIDED|95.0|-0.3|0.1|||t-test, 1 sided|||||.10|-.30|0.3
73908728|NCT00573183|147347492|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3404|STANDARD_ERROR_OF_MEAN|0.4134|<|0.05|TWO_SIDED|95.0|1.2019|9.2842||95% confidence interval|Mixed Models Analysis|A covariate adjustment was used: average number of days of stimulant use within a 30-day window of assessment from 90 days pre-baseline to baseline.|The STAGE-12 group represented the numerator and TAU represented the reference group/denominator|Mixture model with a logistic part for assessing zero-inflation and a negative binomial part for the over-dispersed count data, with corresponding 95% confidence intervals (CIs) of the odds ratios for logistic part and incidence rate ratios for negative binomial part.||9.2842|1.2019|<0.05
73908729|NCT00573183|147347492|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4373|STANDARD_ERROR_OF_MEAN|0.4134|<|0.01|TWO_SIDED|95.0|1.0131|5.8637|||Mixed Models Analysis|||||5.8637|1.0131|<0.01
73908730|NCT00573183|147347493|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical Model - zero-inflated negative binomial random-effects regression|Zero-inflated negative binomial random-e|Statistical Model - zero-inflated negative binomial random-effects regression adjusted for average number of days of pre-baseline attendance||Outcome measure: Number of days of self-reported Self-Help meeting attendance by the Substance Use Calendar (SUC) within a 30-day window of assessment at mid-treatment, end-of-treatment, first, second, third and last follow-ups||||<0.05
73908731|NCT03423641|147347502|SUPERIORITY||Odds Ratio (OR)|0.81||||0.68|TWO_SIDED|95.0|0.3|2.2|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||2.20|0.30|.68
73908732|NCT03423641|147347503|SUPERIORITY||Odds Ratio (OR)|0.71||||0.01|TWO_SIDED|95.0|0.56|0.91|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.91|0.56|0.01
73908733|NCT03423641|147347504|SUPERIORITY||Odds Ratio (OR)|0.92||||0.39|TWO_SIDED|95.0|0.75|1.12|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.12|0.75|0.39
73908734|NCT03423641|147347505|SUPERIORITY||Odds Ratio (OR)|0.67||||0.01|TWO_SIDED|95.0|0.49|0.9|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.90|0.49|0.01
73908735|NCT03423641|147347506|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.01|TWO_SIDED|95.0|0.3|0.59|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.59|0.30|<0.01
73908736|NCT03423641|147347507|SUPERIORITY||Odds Ratio (OR)|0.68||||0.12|TWO_SIDED|95.0|0.42|1.1|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.10|0.42|0.12
74026162|NCT02786537|147605507|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero.|Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-4.2|7.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free PrOD vs. SOF/LDV regimens (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date)||7.0|-4.2|
73857660|NCT02950155|147260566|SUPERIORITY||probability ratio|2.48||||0.007|TWO_SIDED|95.0|1.2|5.11|||Fisher Exact|||The primary end-point was analyzed as an intention-to-treat analysis, with Fisher's exact test of the difference in proportion, with α=0·05 to indicate statistically significant difference||5.11|1.20|0.007
73857661|NCT02950155|147260567|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.79|TWO_SIDED|95.0|-4.4|2.1|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||2.1|-4.4|0.79
73857662|NCT02950155|147260568|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.34|TWO_SIDED|95.0|-3.3|0.8|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||0.8|-3.3|0.34
73857663|NCT02950155|147260569|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.47|TWO_SIDED|95.0|-8.2|3.8|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||3.8|-8.2|0.47
73857664|NCT02950155|147260570|SUPERIORITY||probability ratio|1.89||||0.036|TWO_SIDED|95.0|1.04|3.44|||Fisher Exact|||||3.44|1.04|0.036
73857665|NCT02979093|147260577|SUPERIORITY||Mean Difference (Final Values)|0.1697|STANDARD_ERROR_OF_MEAN|0.1025||0.106|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Striatum: Happy Own vs. Happy Unknown||||0.106
73857666|NCT02979093|147260577|SUPERIORITY||Mean Difference (Final Values)|0.20458|STANDARD_ERROR_OF_MEAN|0.1101||0.0709|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for the Amygdala: Happy Own vs. Happy Unknown infant faces.||||0.0709
73857667|NCT02979093|147260577|SUPERIORITY||Mean Difference (Final Values)|-0.14559|STANDARD_ERROR_OF_MEAN|0.08546||0.0964|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Striatum: Sad Own vs. Sad Unknown infant faces.||||0.0964
73857668|NCT02979093|147260577|SUPERIORITY||Mean Difference (Final Values)|-0.15755|STANDARD_ERROR_OF_MEAN|0.07914||0.0538|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Amygdala: Sad Own vs. Sad Unknown infant faces.||||0.0538
73857669|NCT02979093|147260578|SUPERIORITY||Mean Difference (Final Values)|0.09778|STANDARD_ERROR_OF_MEAN|0.09687||0.319|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (Addiction vs. Control) and condition (Oxytocin \[OT\] vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on OT vs. placebo for Ventromedial prefrontal cortex (vmPFC) for happy own vs. happy unknown infant faces."||||0.319
74026163|NCT02786537|147605508|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-1.6|1.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free EBR/GZR vs. SOF/LDV (all patients who started treatment by arm as treated)||1.3|-1.6|
74026164|NCT02786537|147605511|SUPERIORITY|Superiority test based on whether the 95% CI includes zero|Mean Difference (Net)|1.8|||||TWO_SIDED|95.0|-1.9|5.5|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free EBR/GZR vs. PrOD regimens as reported in PRO (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date). Analysis limited to RBV free regimen in consideration RBV usage determined by provider and not study randomization.||5.5|-1.9|
73857670|NCT02979093|147260578|SUPERIORITY||Mean Difference (Final Values)|-0.15289|STANDARD_ERROR_OF_MEAN|0.10968||0.171|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on addiction vs. control for vmPFC for Happy Own vs. Happy Unknown infant faces."||||0.171
73857671|NCT02979093|147260578|SUPERIORITY||Mean Difference (Final Values)|-0.20839|STANDARD_ERROR_OF_MEAN|0.08405||0.0179|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on OT vs placebo for Dorsolateral Prefrontal Cortex (dlPFC) for Sad Own vs. Sad Unknown infant faces."||||0.0179
73857672|NCT02979093|147260578|SUPERIORITY||Mean Difference (Final Values)|0.04315|STANDARD_ERROR_OF_MEAN|0.11827||0.7171|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on addiction vs. control for dlPFC for Sad Own vs. Sad Unknown infant faces."||||0.7171
73857673|NCT02308163|147260602|SUPERIORITY||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.76|5.58||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.58|1.76|<0.001
73857674|NCT02308163|147260602|SUPERIORITY||Odds Ratio (OR)|6.59|||<|0.001|TWO_SIDED|95.0|3.56|12.2||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.20|3.56|<0.001
73857675|NCT02308163|147260604|SUPERIORITY||Odds Ratio (OR)|4.79|||<|0.001|TWO_SIDED|95.0|2.14|10.75||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||10.75|2.14|<0.001
73908737|NCT03423641|147347508|SUPERIORITY||Odds Ratio (OR)|0.61||||0.34|TWO_SIDED|95.0|0.22|1.7|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.70|0.22|0.34
73908738|NCT03423641|147347509|SUPERIORITY||Marginal Structural Model|0.61|||<|0.01|TWO_SIDED|95.0|0.49|0.76|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.76|0.49|<0.01
73908739|NCT03423641|147347510|SUPERIORITY||Rate Ratio|0.71|||<|0.01|TWO_SIDED|95.0|0.6|0.84|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.|||0.84|0.60|<0.01
73908740|NCT03423641|147347511|SUPERIORITY||Rate Ratio|0.82|||<|0.01|TWO_SIDED|95.0|0.77|0.87|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.|||0.87|0.77|<0.01
73908741|NCT03423641|147347512|SUPERIORITY||Odds Ratio (OR)|0.47||||0.02|TWO_SIDED|95.0|0.25|0.88|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.88|0.25|0.02
73908742|NCT03423641|147347513|SUPERIORITY||Odds Ratio (OR)|0.62||||0.07|TWO_SIDED|95.0|0.37|1.03|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.03|0.37|0.07
73908743|NCT03423641|147347514|SUPERIORITY||Odds Ratio (OR)|0.81||||0.11|TWO_SIDED|95.0|0.63|1.05|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.05|0.63|0.11
73908744|NCT03270644|147347533|OTHER||Difference of LSMeans|-5.45|||||TWO_SIDED|90.0|-7.27|-3.64||||||Mean hourly HR was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||-3.64|-7.27|
74026165|NCT02786537|147605511|SUPERIORITY|Superiority test based on whether the 95% CI includes zero|Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-4.6|2.7|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free SOF/LDV vs. PrOD regimens as reported in PRO (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date)||2.7|-4.6|
73908745|NCT03270644|147347534|OTHER||Ratio of Geometric LSMeans|0.884|||||TWO_SIDED|90.0|0.832|0.939||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||0.939|0.832|
73908746|NCT03270644|147347535|OTHER||Ratio of Geometric LSMeans|0.958|||||TWO_SIDED|90.0|0.917|1.0||||||Ratio of geometric LSMeans of Cmax used a mixed-effects repeated measures model adjusted for fixed effects for treatment, time point, time point by treatment, and random effect for subjects.||1.00|0.917|
73908747|NCT03270644|147347536|OTHER||Ratio of Geometric LSMeans|1.01|||||TWO_SIDED|90.0|0.967|1.04||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||1.04|0.967|
73908748|NCT03270644|147347537|OTHER||Ratio of Geometric LSMeans|0.999|||||TWO_SIDED|90.0|0.967|1.03||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||1.03|0.967|
73908749|NCT03270644|147347538|OTHER||Difference of LSMeans|-3.51|||||TWO_SIDED|90.0|-6.39|-0.64||||||PR interval was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||-0.64|-6.39|
73908750|NCT03270644|147347539|OTHER||Difference of LSMeans|5.57|||||TWO_SIDED|90.0|3.57|7.57||||||Systolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||7.57|3.57|
73908751|NCT03270644|147347540|OTHER||Difference of LSMeans|3.47|||||TWO_SIDED|90.0|1.99|4.95||||||Diastolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||4.95|1.99|
73908752|NCT00986830|147347570|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value of \<0.05 was considered statistically significant.|t-test, 2 sided||||A reduction in SNOT-20 score of 0.8 or more is considered clinically meaningful.|||<0.0001
73908753|NCT00986830|147347571|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
73908754|NCT00986830|147347572|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
73908755|NCT00986830|147347573|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
73908756|NCT00986830|147347574|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
74026166|NCT02786537|147605512|SUPERIORITY|Superiority test comparison based on presence of zero in 95% CI.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-1.4|1.6|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis limited to RBV free regimens in consideration that RBV usage determined by provider and not study randomization. All patients who started treatment by arm as treated.||1.6|-1.4|
73908757|NCT00986830|147347575|SUPERIORITY|||||||0.009||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||0.009
73908758|NCT00986830|147347576|SUPERIORITY|||||||0.292||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||0.292
73908759|NCT00986830|147347577|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||<0.0001
73908760|NCT03800173|147347671|OTHER||Slope|0.982|||||TWO_SIDED|90.0|0.868|1.096||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed Cmax. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.||1.096|0.868|
73908761|NCT03800173|147347672|OTHER||Slope|1.0|||||TWO_SIDED|90.0|0.872|1.128||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed AUC0-inf Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1||1.128|0.872|
73908762|NCT03800173|147347672|OTHER||Slope|1.086|||||TWO_SIDED|90.0|0.952|1.219||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed AUC0-t. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.||1.219|0.952|
73908763|NCT00910273|147347694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.608|TWO_SIDED|95.0|-5.14|8.58|||Mixed Models Analysis|||"Null Hypothesis: No difference in Change in FMD at 12 weeks for Etanercept and placebo.~Alternative Hypothesis: Difference in Change in FMD at 12 weeks for Etanercept and placebo.~Sample size of 36 subjects per treatment arm was planned based on an expected difference of 0.9 in FMD (Standard Deviation \[SD\] 1.5), with 80% power and 5% significance level."||8.58|-5.14|0.608
73964623|NCT03397108|147464772|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Cognitive development at 12 months of age. Animal data suggested that pups receiving milk with lower TNF and TNF-dependent chemokines showed enhanced cognitive development. Because there was no guiding information in humans regarding milk TNF level differences between women with and without IBD, our main goal was to measure milk TNF levels. The infant cognitive/language assessment, therefore, had to be designed as a pilot and exploratory in nature.||||0.12
73964624|NCT03397108|147464772|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Language development at 12 months of age.||||0.56
73964625|NCT03397108|147464772|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Cognitive development at 18 months of age.||||0.16
74026167|NCT02786537|147605515|SUPERIORITY|Superiority test determined by comparing presence of zero in CI.|Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-9.9|1.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis based on RBV free regimens -all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date.||1.3|-9.9|
73908764|NCT00910273|147347695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.82||||0.476|TWO_SIDED|95.0|-3.35|7.0|||Mixed Models Analysis||Analyses available for Week 4 only, due to limited number of participants for Week 24 to Week 52.|Week 4||7.00|-3.35|0.476
73908765|NCT00910273|147347696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.65|TWO_SIDED|95.0|-0.08|0.13|||ANCOVA|||Week 12; Common Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.13|-0.08|0.650
73964626|NCT03397108|147464772|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Language development at 18 months of age||||0.75
73908766|NCT00910273|147347696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.513|TWO_SIDED|95.0|-0.13|0.07|||ANCOVA|||Week 12; Common Bulb; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.07|-0.13|0.513
73908767|NCT00910273|147347696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.592|TWO_SIDED|95.0|-0.14|0.08|||ANCOVA|||Week 12; Internal Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.08|-0.14|0.592
73908768|NCT00910273|147347701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0.008|TWO_SIDED|95.0|-3.05|-0.5|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.50|-3.05|0.008
73908769|NCT00910273|147347701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.021|TWO_SIDED|95.0|-3.7|-0.33|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.33|-3.70|0.021
73908770|NCT00910273|147347709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.003|TWO_SIDED|95.0|-1.74|-0.4|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.40|-1.74|0.003
73908771|NCT00910273|147347709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.029|TWO_SIDED|95.0|-1.72|-0.1|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.10|-1.72|0.029
73964627|NCT03397108|147464772|OTHER|Correlation analysis|Spearman rank correlation|0.2655||||0.0853|TWO_SIDED|95.0|-0.047|0.5307|||Spearman rank correlation|||Using pooled data of all participants at the early-lactation sample point, correlation between milk TNF levels and 12 month cognitive development was examined to investigate if they were inversely correlated.||0.5307|-0.047|0.0853
73964628|NCT03397108|147464772|OTHER|Correlation analysis|Spearman rank correlation|0.3705||||0.09|TWO_SIDED|95.0|-0.07385|0.6921|||Spearman rank correlation|||Using the pooled data of all participants, correlation analysis between milk TNF at early lactation and 12 month language score was done to see if they were inversely correlated.||0.6921|-0.07385|0.090
73964629|NCT03397108|147464774|SUPERIORITY|||||||0.97||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||This is to confirm that the 2 groups are not different for their sampling time points in the early lactation period.||||0.97
73964630|NCT03397108|147464774|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||||||0.96
73964631|NCT03397108|147464775|SUPERIORITY|||||||0.56||||||No adjustment for multiple comparison.|Wilcoxon (Mann-Whitney)|||This is to confirm that there is no difference in the second sampling time points in the mid-lactation period between the groups.||||0.56
74026168|NCT02786537|147605515|SUPERIORITY|Superiority comparison by viewing presence of zero in CI.|Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-3.4|9.4||||||RBV free regimens as reported in PRO (all patients who started treatment by arm as treated, population limited to as randomization date of the last PrOD patient start date)||9.4|-3.4|
73908772|NCT00910273|147347715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.041|TWO_SIDED|95.0|-2.13|-0.05|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.05|-2.13|0.041
73908773|NCT00910273|147347715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.048|TWO_SIDED|95.0|-2.55|-0.01|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.01|-2.55|0.048
73908774|NCT00910273|147347716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.575|TWO_SIDED|95.0|-0.89|1.57|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||1.57|-0.89|0.575
73908775|NCT00910273|147347716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.204|TWO_SIDED|95.0|-0.52|2.3|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||2.30|-0.52|0.204
73908776|NCT01011738|147347719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.349||||0.0022|TWO_SIDED|95.0|1.542|7.271||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||7.271|1.542|0.0022
73964632|NCT03397108|147464775|SUPERIORITY|||||||0.51|||||||Kruskal-Wallis|||||||0.51
73964633|NCT02217904|147464845|SUPERIORITY||Posterior mean difference|-1.64|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
74026169|NCT02786537|147605517|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-3.6|2.1|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|Analysis based on RBV free regimens in consideration that RBV usage was determined by provider and not study randomization. Population includes patients who started treatment by arm as treated.||2.1|-3.6|
74026170|NCT02786537|147605526|EQUIVALENCE|Pre-specified equivalence range +/-5%|Mean Difference (Net)|-2.3|||||TWO_SIDED|95.0|-15.3|11.3||||||||11.3|-15.3|
74026171|NCT03440112|147605546|SUPERIORITY||Chi-Squared|3.0039||||0.391|TWO_SIDED||||||Mixed Models Analysis|||A pair of random-intercept mixed linear models was fitted, a visit model and an interaction model. Visit model included fixed effect of visit and a random intercept by participant. Interaction model adds an interaction by treatment term on top of the visit model. Null hypothesis is that visit by treatment interaction does not explain significant additional variance in clinical outcome scores. Likelihood ratio test comparing the interaction model to the visit model was used to derive a p-value.||||0.391
74026172|NCT03440112|147605547|SUPERIORITY||Chi-Squared|9.4836||||0.02351|TWO_SIDED||||||Mixed Models Analysis|||A pair of random-intercept mixed linear models was fitted, a visit model and an interaction model. Visit model included fixed effect of visit and a random intercept by participant. Interaction model adds an interaction by treatment term on top of the visit model. Null hypothesis is that visit by treatment interaction does not explain significant additional variance in clinical outcome scores. Likelihood ratio test comparing the interaction model to the visit model was used to derive a p-value.||||0.02351
74026173|NCT00443560|147605548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.01||95.0|2.3|4.5|||Chi-squared, Corrected|||||4.5|2.3|<0.01
73908777|NCT01011738|147347719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.595||||0.0019|TWO_SIDED|95.0|1.603|8.063||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.||8.063|1.603|0.0019
73908778|NCT01011738|147347719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.851||||0.0369|TWO_SIDED|95.0|0.732|0.99||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Weight in kg was analyzed as independent predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||0.990|0.732|0.0369
73908779|NCT01011738|147347723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0033|TWO_SIDED|95.0|0.045|0.539||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||0.539|0.045|0.0033
73908780|NCT01011738|147347723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.191||||0.0042|TWO_SIDED|95.0|0.062|0.594|||Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.||0.594|0.062|0.0042
73908781|NCT01011738|147347723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.528||||0.0149|TWO_SIDED|95.0|1.086|2.15||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, ALT ratio was analysed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||2.150|1.086|0.0149
74026174|NCT00443560|147605549|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.2|||<|0.01||95.0|9.9|15.0|||Chi-squared, Corrected|||||15.0|9.9|<0.01
74026175|NCT00443560|147605550|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
73908782|NCT03841448|147347734|SUPERIORITY||Placebo-adjusted GM Percent Change|-37.367||||0.1032|TWO_SIDED|90.0|-60.951|0.46|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS mean difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||0.460|-60.951|0.1032
73908783|NCT03841448|147347735|SUPERIORITY||Placebo-adjusted GM Percent Change|-36.167||||0.1432|TWO_SIDED|90.0|-61.552|5.978|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS mean difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||5.978|-61.552|0.1432
73908784|NCT03841448|147347736|SUPERIORITY||Odds Ratio (OR)|3.01||||0.1177|TWO_SIDED|90.0|0.43|21.27|||Cochran-Mantel-Haenszel|p-value was based on Cochran-Mantel-Haenszel test stratified by baseline 24-hour UP (≥1.0 g and \<2 g/day versus ≥2.0 g/day).|Odds ratio was estimated with logit method using a correction of 0.5 in every cell of the 2x2 table that contains a zero.|||21.27|0.43|0.1177
73964634|NCT02217904|147464845|SUPERIORITY||Posterior mean difference|-1.32|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
73908785|NCT03841448|147347736|SUPERIORITY||Difference in Proportions|0.23|||||TWO_SIDED|90.0|-0.13|0.42|||||Difference in proportions (cemdisiran - placebo) (90% CI) was based on the Wilson score method with continuity correction.|||0.42|-0.13|
73964635|NCT02217904|147464845|SUPERIORITY||Posterior mean difference|-1.57|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
73964636|NCT02217904|147464845|SUPERIORITY||Posterior mean difference|-1.28|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
73964637|NCT02217904|147464845|SUPERIORITY||Posterior mean difference|-1.18|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
73964638|NCT04500301|147464895|OTHER|No statistical test was performed.|Proportion|0.136|||||TWO_SIDED|95.0|0.054|0.219|||||The Wald 95% confidence interval for the binomial proportion was estimated.|No hypothesis was tested with regard to the primary outcome. The study planned to enroll 80 eligible subjects such that at least 65 would be evaluable for the primary outcome and the width of the 95% Clopper-Pearson confidence interval for the proportion would be less than or equal to .25.||0.219|0.054|
73964639|NCT03456076|147464994|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0001|TWO_SIDED|95.0|0.13|0.45|||Log Rank|||||0.45|0.13|.0001
74085222|NCT00513617|147724091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3582|STANDARD_ERROR_OF_MEAN|4.1047||0.918||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.918
73964640|NCT03456076|147464994|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0001|TWO_SIDED|95.0|0.13|0.43|||Log Rank|||||0.43|0.13|.0001
73908786|NCT03841448|147347737|SUPERIORITY||Odds Ratio (OR)|3.02||||0.1533|TWO_SIDED|90.0|0.45|20.34|||Cochran-Mantel-Haenszel|p-value was based on Cochran-Mantel-Haenszel test stratified by baseline 24-hour UP (≥1.0 g and \<2 g/day versus ≥2.0 g/day).|Odds ratio was estimated with logit method using a correction of 0.5 in every cell of the 2x2 table that contains a zero.|||20.34|0.45|0.1533
73908787|NCT03841448|147347737|SUPERIORITY||Difference in Proportions|0.23|||||TWO_SIDED|90.0|-0.13|0.42|||||Difference in proportions (cemdisiran - placebo) (90% CI) was based on the Wilson score method with continuity correction.|||0.42|-0.13|
73908788|NCT03841448|147347738|SUPERIORITY||Placebo-adjusted GM Percent Change|-45.771||||0.0021|TWO_SIDED|90.0|-60.093|-26.309|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS means difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||-26.309|-60.093|0.0021
73908789|NCT01163266|147347741|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|1.151||0.058|TWO_SIDED|95.0|-4.45|0.08||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||0.08|-4.45|0.058
73964641|NCT03990649|147465011|SUPERIORITY|||||||0.54||||||The p-values were estimated using a two-sample t-test.|t-test, 2 sided|||||||0.540
74085223|NCT00513617|147724092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7867|STANDARD_ERROR_OF_MEAN|1.1101||0.015||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.015
74085224|NCT00513617|147724092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5213|STANDARD_ERROR_OF_MEAN|1.1553||0.557||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.557
73908790|NCT01163266|147347741|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|1.161||0.002|TWO_SIDED|95.0|-5.92|-1.35||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.025, hierarchical testing continues.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-1.35|-5.92|0.002
73908791|NCT01163266|147347742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.301|TWO_SIDED|95.0|0.796|2.093|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||2.093|0.796|0.301
73908792|NCT01163266|147347742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.639||||0.044|TWO_SIDED|95.0|1.013|2.652||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||2.652|1.013|0.044
73908793|NCT01163266|147347743|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.129||0.119|TWO_SIDED|95.0|-0.45|0.05|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.05|-0.45|0.119
73908794|NCT01163266|147347743|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.129||0.024|TWO_SIDED|95.0|-0.55|-0.04|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||-0.04|-0.55|0.024
73908795|NCT01163266|147347744|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.29|STANDARD_ERROR_OF_MEAN|1.891||0.025|TWO_SIDED|95.0|-8.03|-0.56|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS Total score-by-week as fixed effects.||||-0.56|-8.03|0.025
73908796|NCT01163266|147347744|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.26|STANDARD_ERROR_OF_MEAN|1.852|<|0.001|TWO_SIDED|95.0|-10.92|-3.6|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-3.60|-10.92|<0.001
73964642|NCT00431834|147465017|SUPERIORITY_OR_OTHER||binomial proportions|37.7|||<|0.0041|ONE_SIDED|97.5|25.6|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percenter of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%"|||25.6|<0.0041
73908797|NCT01163266|147347745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.665||||0.093|TWO_SIDED|95.0|0.918|3.018|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.018|0.918|0.093
73908798|NCT01163266|147347745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.779||||0.059|TWO_SIDED|95.0|0.979|3.233|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.233|0.979|0.059
73908799|NCT01163266|147347746|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.042||0.183|TWO_SIDED|95.0|-3.44|0.66|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||0.66|-3.44|0.183
73908800|NCT01163266|147347746|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.066||0.025|TWO_SIDED|95.0|-4.5|-0.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||-0.30|-4.50|0.025
73908801|NCT02586064|147347747|OTHER|||||||0.28|||||||t-test, 1 sided|||Baseline||||0.28
73908802|NCT02586064|147347747|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|1.52|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|||||||||||||
73908803|NCT02586064|147347747|OTHER|||||||0.87|||||||t-test, 1 sided|||End of Treatment||||0.87
73908804|NCT02586064|147347747|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|||||||||||||
73908805|NCT02586064|147347747|EQUIVALENCE|Equivalence hypothesis was assessed using the confidence intervals for the mean differences compared to margins of equivalence (-7,7). The equivalence hypothesis was examined based on the difference between the amount of change from the baseline to the end of treatment on the CAPS between the two conditions. Confidence interval is -7.0 to 1.9.||||||0.26|||||||t-test, 2 sided|||Change||||0.26
73908806|NCT02586064|147347747|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|2.25|||TWO_SIDED|||||||||||||
73908807|NCT02586064|147347747|OTHER|||||||0.68|||||||t-test, 1 sided|||3 Month Post Treatment||||0.68
73908808|NCT02586064|147347747|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|||||||||||||
73908809|NCT02586064|147347747|OTHER|||||||0.84|||||||t-test, 1 sided|||6 Month Follow Up||||0.84
73908810|NCT02586064|147347747|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|3.05|||TWO_SIDED|||||||||||||
73908811|NCT02586064|147347748|OTHER|||||||0.36|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||Baseline||||0.36
73908812|NCT02586064|147347748|OTHER|||||||0.34|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||4-Week||||0.34
73908813|NCT02586064|147347748|OTHER|||||||0.43|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||8-Week||||0.43
73857676|NCT02308163|147260604|SUPERIORITY||Odds Ratio (OR)|7.86|||<|0.001|TWO_SIDED|95.0|3.53|17.5||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||17.50|3.53|<0.001
73857677|NCT02308163|147260606|SUPERIORITY||Odds Ratio (OR)|39.93|||<|0.001|TWO_SIDED|95.0|5.29|301.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR70-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.||301.61|5.29|<0.001
73857678|NCT02308163|147260608|SUPERIORITY||LS mean|-1.06|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.41|-0.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.71|-1.41|<0.001
73857679|NCT02308163|147260608|SUPERIORITY||LS mean|-1.55|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.86|-1.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.24|-1.86|<0.001
73857680|NCT02308163|147260610|SUPERIORITY||LS mean|-1.03|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.38|-0.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.67|-1.38|<0.001
73857681|NCT02308163|147260610|SUPERIORITY||LS mean|-1.64|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.96|-1.31||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.31|-1.96|<0.001
74026176|NCT01943539|147605551|SUPERIORITY||Effect Size|0.62||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
74026177|NCT02413255|147605563|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0195||||0.465|TWO_SIDED|90.0|0.9752|1.0637|||Power Model|||||1.0637|0.9752|0.465
74026178|NCT02413255|147605564|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.1124||||0.126|TWO_SIDED|90.0|0.9913|1.2336|||Power Model|||Day 1||1.2336|0.9913|0.126
74026179|NCT02413255|147605564|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.09||||0.114|TWO_SIDED|90.0|0.9962|1.1838|||Power Model|||Day 9||1.1838|0.9962|0.114
74026180|NCT02413255|147605565|SUPERIORITY|||||||0.5402|||||||ANOVA|Statistical analysis results were obtained using Analysis of Variance (ANOVA) with dose level as a fixed effect.||||||0.5402
74026181|NCT02413255|147605566|SUPERIORITY|||||||0.7824|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 1||||0.7824
74026182|NCT02413255|147605566|SUPERIORITY|||||||0.4056|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 9||||0.4056
74026183|NCT02413255|147605567|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0606||||0.019|TWO_SIDED|90.0|1.0187|1.1026|||Power Model|||||1.1026|1.0187|0.019
74026184|NCT02413255|147605568|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0789||||0.258|TWO_SIDED|90.0|0.9628|1.195|||Power Model|||Day 1||1.1950|0.9628|0.258
74026185|NCT02413255|147605568|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0929||||0.144|TWO_SIDED|90.0|0.9878|1.198|||Power Model|||Day 9||1.1980|0.9878|0.144
74026186|NCT02413255|147605571|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0799||||0.003|TWO_SIDED|90.0|1.0371|1.1227|||Power Model|||||1.1227|1.0371|0.003
74026187|NCT02413255|147605572|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0897||||0.201|TWO_SIDED|90.0|0.9735|1.206|||Power Model|||||1.2060|0.9735|0.201
74026188|NCT02413255|147605573|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0188||||0.49|TWO_SIDED|90.0|0.9734|1.0642|||Power Model|||||1.0642|0.9734|0.490
74026189|NCT02413255|147605574|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0846||||0.224|TWO_SIDED|90.0|0.969|1.2002|||Power Model|||||1.2002|0.9690|0.224
74026190|NCT02413255|147605581|SUPERIORITY||||||<|0.0001|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||||||<.0001
74026191|NCT02413255|147605597|OTHER||Estimated Ratio|1.121|||||TWO_SIDED|90.0|0.772|1.628||||||||1.628|0.772|
74026192|NCT02413255|147605597|OTHER||Estimated Ratio|1.156|||||TWO_SIDED|90.0|0.796|1.678||||||||1.678|0.796|
74026193|NCT02413255|147605597|OTHER||Estimated Ratio|0.982|||||TWO_SIDED|90.0|0.676|1.425||||||||1.425|0.676|
73857682|NCT02308163|147260612|SUPERIORITY||LS mean|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-6.8|-2.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-2.4|-6.8|<0.001
73857683|NCT02308163|147260612|SUPERIORITY||LS mean|-6.1|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-8.1|-4.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-4.0|-8.1|<0.001
73857684|NCT02308163|147260614|SUPERIORITY||LS mean|-3.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-4.6|-1.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.4|-4.6|<0.001
73857685|NCT02308163|147260614|SUPERIORITY||LS mean|-5.3|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-6.8|-3.9||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-3.9|-6.8|<0.001
73857686|NCT02308163|147260616|SUPERIORITY||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.31|17.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||17.67|2.31|<0.001
73857687|NCT02308163|147260616|SUPERIORITY||Odds Ratio (OR)|10.13|||<|0.001|TWO_SIDED|95.0|3.76|27.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||27.27|3.76|<0.001
73857688|NCT02308163|147260618|SUPERIORITY||Odds Ratio (OR)|21.72||||0.003|TWO_SIDED|95.0|2.83|166.66||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.||166.66|2.83|0.003
73857689|NCT02308163|147260620|SUPERIORITY||Odds Ratio (OR)|5.8|||<|0.001|TWO_SIDED|95.0|2.74|12.29||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.29|2.74|<0.001
73857690|NCT02308163|147260620|SUPERIORITY||Odds Ratio (OR)|9.66|||<|0.001|TWO_SIDED|95.0|4.57|20.41||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||20.41|4.57|<0.001
73857691|NCT02308163|147260622|SUPERIORITY||Odds Ratio (OR)|3.24||||0.012|TWO_SIDED|95.0|1.29|8.12||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||8.12|1.29|0.012
73908814|NCT02586064|147347748|OTHER|||||||0.09|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||6 Month Post Treatment||||0.09
73908815|NCT02586064|147347748|OTHER|||||||0.41|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||End of Treatment||||0.41
73908816|NCT02586064|147347748|SUPERIORITY|Superiority hypotheses were assessed using the confidence interval for the mean differences (-0.33 to 0.20) compared to margin of superiority (-.05).||||||0.64|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||Change||||0.64
73908817|NCT02586064|147347748|OTHER|||||||0.22|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||3 Month Post Treatment||||0.22
73908818|NCT02586064|147347749|OTHER|||||||0.4|||||||t-test, 1 sided|||Baseline||||0.40
73908819|NCT02586064|147347749|OTHER|||||||0.65|||||||t-test, 1 sided|||End of Treatment||||0.65
73908820|NCT02586064|147347749|OTHER|||||||0.64|||||||t-test, 1 sided|||Change||||0.64
73908821|NCT02586064|147347749|OTHER|||||||0.64|||||||t-test, 1 sided|||3 Month Post Treatment||||0.64
73908822|NCT02586064|147347749|OTHER|||||||0.76|||||||t-test, 1 sided|||6 Month Post Treatment||||0.76
73908823|NCT02586064|147347750|OTHER|||||||0.11|||||||t-test, 1 sided|||Baseline||||0.11
73908824|NCT02586064|147347750|OTHER|||||||0.48|||||||t-test, 1 sided|||4-Week||||0.48
73908825|NCT02586064|147347750|OTHER|||||||0.74|||||||t-test, 1 sided|||8-Week||||0.74
73908826|NCT02586064|147347750|OTHER|||||||0.34|||||||t-test, 1 sided|||End of Treatment||||0.34
73908827|NCT02586064|147347750|OTHER|||||||0.65|||||||t-test, 1 sided|||Change||||0.65
73908828|NCT02586064|147347750|OTHER|||||||0.14|||||||t-test, 1 sided|||3 Month Post Treatment||||0.14
73908829|NCT02586064|147347750|OTHER|||||||0.18|||||||t-test, 1 sided|||6 Month Post Treatment||||0.18
73908830|NCT02586064|147347751|OTHER|||||||0.08|||||||t-test, 1 sided|||Baseline||||0.08
73908831|NCT02586064|147347751|OTHER|||||||0.07|||||||t-test, 1 sided|||End of Treatment||||0.07
73908832|NCT02586064|147347751|OTHER|||||||0.86|||||||t-test, 1 sided|||Change||||0.86
74026194|NCT02413255|147605597|OTHER||Estimated Ratio|1.055|||||TWO_SIDED|90.0|0.701|1.587||||||||1.587|0.701|
74026195|NCT02413255|147605597|OTHER||Estimated Ratio|1.105|||||TWO_SIDED|90.0|0.761|1.604||||||||1.604|0.761|
74026196|NCT02413255|147605597|OTHER||Estimated Ratio|1.225|||||TWO_SIDED|90.0|0.844|1.778||||||||1.778|0.844|
74026197|NCT03199911|147605598|SUPERIORITY||Risk Ratio (RR)|0.0||||0.025|TWO_SIDED||||||Fisher Exact|||||||0.025
74026198|NCT03199911|147605600|SUPERIORITY||Risk Ratio (RR)|1.3||||0.77|TWO_SIDED|95.0|0.42|4.03|||Fisher Exact|||||4.03|0.42|0.77
74026199|NCT03199911|147605601|SUPERIORITY||Risk Ratio (RR)|0.93||||1|TWO_SIDED|95.0|0.06|14.77|||Fisher Exact|||||14.77|0.06|1.00
74026200|NCT01009463|147605602|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.181|TWO_SIDED|95.0|0.72|1.06|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.06|0.72|0.181
74085225|NCT01091103|147724099|SUPERIORITY_OR_OTHER|||||||0.9427|TWO_SIDED|||||The p-value was not adjusted for multiplicity.|t-test, 2 sided|||||||0.9427
74085226|NCT01091103|147724100|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED|||||The p-value was not adjusted for multiplicity.|t-test, 2 sided|||||||0.3370
73857692|NCT02308163|147260622|SUPERIORITY||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|96.0|3.42|19.63||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||19.63|3.42|<0.001
73857693|NCT02308163|147260624|SUPERIORITY||LS Mean|-1.112|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.546|-0.679||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.679|-1.546|<0.001
73857694|NCT02308163|147260624|SUPERIORITY||LS mean|-1.677|STANDARD_ERROR_OF_MEAN|0.221|<|0.001|TWO_SIDED|95.0|-2.114|-1.241||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.241|-2.114|<0.001
73857695|NCT02308163|147260626|SUPERIORITY||LS mean|-10.9|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-15.95|-5.84||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-5.84|-15.95|<0.001
73857696|NCT02308163|147260626|SUPERIORITY||LS mean|-21.14|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-26.01|-16.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-16.27|-26.01|<0.001
73908833|NCT02586064|147347751|OTHER|||||||0.003|||||||t-test, 1 sided|||3 Month Post Treatment||||0.003
73908834|NCT02586064|147347751|OTHER|||||||0.03|||||||t-test, 1 sided|||6 Month Post Treatment||||0.03
73908835|NCT02586064|147347752|OTHER|||||||0.05|||||||t-test, 1 sided|||Baseline||||0.05
73908836|NCT02586064|147347752|OTHER|||||||0.04|||||||t-test, 1 sided|||End of Treatment||||0.04
73908837|NCT02586064|147347752|OTHER|||||||0.86|||||||t-test, 1 sided|||Change||||0.86
73908838|NCT02586064|147347752|OTHER||||||<|0.001|||||||t-test, 1 sided|||3 Month Post Treatment||||<0.001
73908839|NCT02586064|147347752|OTHER|||||||0.16|||||||t-test, 1 sided|||6 Month Post Treatment||||0.16
73908840|NCT02586064|147347753|OTHER|||||||0.45|||||||t-test, 1 sided|||Baseline||||0.45
73908841|NCT02586064|147347753|OTHER|||||||0.71|||||||t-test, 1 sided|||End of Treatment||||0.71
73908842|NCT02586064|147347753|OTHER|||||||0.6|||||||t-test, 1 sided|||Change||||0.60
73908843|NCT02586064|147347753|OTHER|||||||0.13|||||||t-test, 1 sided|||3 Month Post Treatment||||0.13
73908844|NCT02586064|147347753|OTHER|||||||0.8|||||||t-test, 1 sided|||6 Month Post Treatment||||0.80
73908845|NCT02586064|147347754|OTHER|||||||0.35|||||||t-test, 1 sided|||Baseline||||0.35
73908846|NCT02586064|147347754|OTHER|||||||0.11|||||||t-test, 1 sided|||End of Treatment||||0.11
73908847|NCT02586064|147347754|OTHER|||||||0.74|||||||t-test, 1 sided|||Change||||0.74
73908848|NCT02586064|147347754|OTHER|||||||0.03|||||||t-test, 1 sided|||3 Month Post Treatment||||0.03
73908849|NCT02586064|147347754|OTHER|||||||0.22|||||||t-test, 1 sided|||6 Month Post Treatment||||0.22
73908850|NCT02586064|147347755|OTHER|||||||0.39|||||||t-test, 1 sided|||Baseline||||0.39
73908851|NCT02586064|147347755|OTHER|||||||0.15|||||||t-test, 1 sided|||End of Treatment||||0.15
73908852|NCT02586064|147347755|OTHER|||||||0.72|||||||t-test, 1 sided|||Change||||0.72
73908853|NCT02586064|147347755|OTHER|||||||0.04|||||||t-test, 1 sided|||3 Month Post Treatment||||0.04
73908854|NCT02586064|147347755|OTHER|||||||0.19|||||||t-test, 1 sided|||6 Month Post Treatment||||0.19
73908855|NCT02586064|147347756|OTHER|||||||0.33|||||||t-test, 1 sided|||Baseline||||0.33
73908856|NCT02586064|147347756|OTHER|||||||0.11|||||||t-test, 1 sided|||End of Treatment||||0.11
73908857|NCT02586064|147347756|OTHER|||||||0.88|||||||t-test, 1 sided|||Change||||0.88
73908858|NCT02586064|147347756|OTHER|||||||0.06|||||||t-test, 1 sided|||3 Month Post Treatment||||0.06
73908859|NCT02586064|147347756|OTHER|||||||0.56|||||||t-test, 1 sided|||6 Month Post Treatment||||0.56
73908860|NCT02586064|147347757|OTHER|||||||0.16|||||||t-test, 1 sided|||Baseline||||0.16
73908861|NCT02586064|147347757|OTHER|||||||0.06|||||||t-test, 1 sided|||End of Treatment||||0.06
73908862|NCT02586064|147347757|OTHER|||||||0.46|||||||t-test, 1 sided|||Change||||0.46
73908863|NCT02586064|147347757|OTHER|||||||0.001|||||||t-test, 1 sided|||3 Month Post Treatment||||0.001
73908864|NCT02586064|147347757|OTHER|||||||0.002|||||||t-test, 1 sided|||6 Month Post Treatment||||0.002
73908865|NCT02586064|147347758|OTHER|||||||0.24|||||||t-test, 1 sided|||Baseline||||0.24
73908866|NCT02586064|147347758|OTHER|||||||0.81|||||||t-test, 1 sided|||End of Treatment||||0.81
73908867|NCT02586064|147347758|OTHER|||||||0.24|||||||t-test, 1 sided|||Change||||0.24
73908868|NCT02586064|147347759|OTHER|||||||0.41|||||||t-test, 1 sided|||Baseline||||0.41
73964643|NCT00431834|147465020|SUPERIORITY_OR_OTHER||binomial proportions|5.3|||<|0.0001|ONE_SIDED|97.5||13.1||The percent of subjects following treatment, p, who experience any of the MAEs during the first 30 days following surgery, or hospital discharge, whichever is longer will be less than 23.6%.|Fisher Exact|||"The specific test hypothesis is as follows:~H0: p ≥ 23.6% Ha: p \< 23.6%"||13.1||<0.0001
73964644|NCT03628885|147465025|SUPERIORITY||||||<|0.02||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||||||<.02
73964645|NCT03628885|147465025|SUPERIORITY||||||=|0.07||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||||||=.07
73964646|NCT03628885|147465025|SUPERIORITY||||||<|0.01||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05||||<.01
74026201|NCT01009463|147605602|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.81||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.81|0.54|<0.001
74026202|NCT01009463|147605602|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.109|TWO_SIDED|95.0|0.7|1.04|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.04|0.70|0.109
73908869|NCT02586064|147347759|OTHER|||||||0.21|||||||t-test, 1 sided|||End of Treatment||||0.21
73908870|NCT02586064|147347759|OTHER|||||||0.5|||||||t-test, 1 sided|||Change||||0.50
73908871|NCT02586064|147347760|OTHER|||||||0.7|||||||t-test, 1 sided|||Baseline||||0.70
73908872|NCT02586064|147347760|OTHER|||||||0.96|||||||t-test, 1 sided|||Week 4||||0.96
73964647|NCT00324350|147465031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.678|TWO_SIDED|95.0|0.86|1.27||Analyses were by intention to treat. All analyses adjusted for baseline cardiovascular disease, assignment to blood pressure (BP) trial or lipid trial, assignment to intensive BP intervention in BP trial, and assignment to fibrate in lipid trial.|Regression, Cox|||The BONE ancillary study was designed to have 80% power to detect a relative reduction in risk of non-spine clinical fractures of 22-29%. This was based on an estimated total number of fractures between 259-494, calculated with the following assumptions: rate of clinical non-spine fracture among women in the standard glycemia therapy group between 15 and 25/1000 person yrs, fracture rates for men between 35-40% of the rates for women of the same age, and an avg follow-up time of 4.6 yrs.||1.27|0.86|0.678
74026203|NCT01009463|147605603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.43|TWO_SIDED|95.0|0.76|1.13|||Regression, Cox|||||1.13|0.76|0.430
74026204|NCT01009463|147605603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.59|0.89||Nominal p-value|Regression, Cox|||||0.89|0.59|0.002
73908873|NCT02586064|147347760|OTHER|||||||0.59|||||||t-test, 1 sided|||Week 8||||0.59
73908874|NCT02586064|147347760|OTHER|||||||0.61|||||||t-test, 1 sided|||End of Treatment||||0.61
73908875|NCT02586064|147347760|OTHER|||||||0.84|||||||t-test, 1 sided|||Change||||0.84
73908876|NCT02586064|147347760|OTHER|||||||0.3|||||||t-test, 1 sided|||3 Month Follow Up||||0.30
73908877|NCT02586064|147347760|OTHER|||||||0.16|||||||t-test, 1 sided|||6 Month Post Treatment||||0.16
73908878|NCT03181893|147347761|OTHER||Mean Difference (Final Values)|-14.82|STANDARD_ERROR_OF_MEAN|3.183|<|0.0001|TWO_SIDED|90.0|-20.26|-9.37|||LANCOVA-P model|||||-9.37|-20.26|<0.0001
73908879|NCT03181893|147347778|OTHER||Least Squares Mean Difference|10.83|STANDARD_ERROR_OF_MEAN|10.274||0.1537|TWO_SIDED|90.0|-7.1|28.77|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 4||28.77|-7.10|0.1537
73908880|NCT03181893|147347778|OTHER||Least Squares Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|10.761||0.1312|TWO_SIDED|90.0|-6.29|31.29|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 8||31.29|-6.29|0.1312
73908881|NCT03181893|147347778|OTHER||Least Squares Mean Difference|19.44|STANDARD_ERROR_OF_MEAN|12.161||0.0647|TWO_SIDED|90.0|-1.79|40.68|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 12||40.68|-1.79|0.0647
73908882|NCT02728596|147347804|SUPERIORITY||Odds Ratio (OR)|0.44||||0.21|TWO_SIDED|95.0|0.12|1.57|||Regression, Logistic|Adjusted for age group, comorbidity, race, and Hispanic ethnicity.||PP-CSF use in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||1.57|0.12|0.21
73908883|NCT02728596|147347804|SUPERIORITY||Odds Ratio (OR)|1.18||||0.74|TWO_SIDED|95.0|0.44|3.2|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||3.20|0.44|0.74
73908884|NCT02728596|147347804|SUPERIORITY||Odds Ratio (OR)|2.23||||0.17|TWO_SIDED|95.0|0.7|7.08|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).||7.08|0.70|0.17
73908885|NCT02728596|147347804|SUPERIORITY||Odds Ratio (OR)|0.36||||0.094|TWO_SIDED|95.0|0.11|1.19|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).||1.19|0.11|0.094
73908886|NCT02728596|147347805|SUPERIORITY||Odds Ratio (OR)|1.49||||0.26|TWO_SIDED|95.0|0.75|2.95|||Regression, Logistic|Adjusted for age.||FN incidence rate in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||2.95|0.75|0.26
73908887|NCT02728596|147347805|SUPERIORITY||Odds Ratio (OR)|2.0||||0.51|TWO_SIDED|95.0|0.23|18.8|||Regression, Logistic|Adjusted for cancer type.||FN incidence rate in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||18.80|0.23|0.51
74026205|NCT01009463|147605603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.114|TWO_SIDED|95.0|0.69|1.04|||Regression, Cox|||||1.04|0.69|0.114
74026206|NCT01009463|147605604|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.125|TWO_SIDED|95.0|0.67|1.05|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.05|0.67|0.125
74026207|NCT01009463|147605604|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|||<|0.001|TWO_SIDED|95.0|0.49|0.78||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.78|0.49|<0.001
74026208|NCT01009463|147605604|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.064|TWO_SIDED|95.0|0.64|1.01|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||1.01|0.64|0.064
74026209|NCT01009463|147605605|SUPERIORITY_OR_OTHER||Least squares mean difference|0.041||||0.011|TWO_SIDED|95.0|0.009|0.072||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.072|0.009|0.011
73857697|NCT02308163|147260628|SUPERIORITY||Odds Ratio (OR)|6.64|||<|0.001|TWO_SIDED|95.0|2.98|14.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||14.83|2.98|<0.001
73857698|NCT02308163|147260628|SUPERIORITY||Odds Ratio (OR)|10.86|||<|0.001|TWO_SIDED|95.0|4.91|24.03||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||24.03|4.91|<0.001
73857699|NCT02308163|147260630|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.001|TWO_SIDED|95.0|2.38|8.04||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||8.04|2.38|<0.001
73857700|NCT02308163|147260630|SUPERIORITY||Odds Ratio (OR)|16.78|||<|0.001|TWO_SIDED|95.0|7.31|38.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||38.51|7.31|<0.001
73857701|NCT02308163|147260632|SUPERIORITY||Odds Ratio (OR)|4.29||||0.006|TWO_SIDED|95.0|1.52|12.08||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.08|1.52|0.006
73857702|NCT02308163|147260632|SUPERIORITY||Odds Ratio, log|11.01|||<|0.001|TWO_SIDED|95.0|4.07|29.74||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||29.74|4.07|<0.001
73857703|NCT02308163|147260634|SUPERIORITY||Odds Ratio (OR)|3.82|||<|0.001||95.0|2.11|6.93||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||6.93|2.11|<0.001
73857704|NCT02308163|147260634|SUPERIORITY||Odds Ratio (OR)|13.65|||<|0.001|TWO_SIDED|95.0|6.39|29.17||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||29.17|6.39|<0.001
73908888|NCT02728596|147347805|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.41|2.88|||Regression, Logistic|||FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).||2.88|0.41|0.87
73908889|NCT02728596|147347805|SUPERIORITY||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.44|3.57|||Regression, Logistic|||FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).||3.57|0.44|0.68
73908890|NCT02728596|147347806|SUPERIORITY||Odds Ratio (OR)|0.87||||0.74|TWO_SIDED|95.0|0.39|1.95|||Regression, Logistic|Adjusted for cancer type.||||1.95|0.39|0.74
73908891|NCT02728596|147347806|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.41|2.88|||Regression, Logistic|Adjusted for cancer type.||||2.88|0.41|0.87
73908892|NCT02728596|147347806|SUPERIORITY||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.44|3.57|||Regression, Logistic|Adjusted for cancer type.||This is comparing the FN incidence rate in the arm randomized to alert against PP-CSF vs usual care in intermediate risk participants.||3.57|0.44|0.68
73908893|NCT03221270|147347818|SUPERIORITY|alternative hypothesis: true difference in means is greater than 0|Median Difference (Final Values)|-0.43||||0.66|ONE_SIDED|95.0|-2.25||||t-test, 1 sided||||||-2.25|0.66
73908894|NCT00165984|147347830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.9||||0.003|TWO_SIDED|95.0|1.7|13.9|||Regression, Cox|||||13.9|1.7|0.003
73908895|NCT03693300|147347924|OTHER||Proportion (%)|6.1|||||TWO_SIDED|95.0|2.5|12.24|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||12.24|2.50|
73908896|NCT03693300|147347924|OTHER||Proportion (%)|0.0|||||TWO_SIDED|95.0|0.0|70.76|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||70.76|0.00|
73964648|NCT00324350|147465032|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.49|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|||Number of participants with falls reported at each annual visit were compared by treatment assignment using a repeated-measures negative binomial model, with robust standard errors to account for clustering of the repeated outcomes within participants; the log of the length of the reporting period varied slightly and was included as an offset||1.43|0.84|0.490
73964649|NCT00324350|147465033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.854|TWO_SIDED|95.0|0.88|1.11|||Mixed Models Analysis||The rate of height loss did not differ between groups (p = 0.573). Height loss of \>2 cm during ACCORD was experienced by 678 (19.5%) participants in the intensive and 686 (19.6%) in the standard glycemia group (OR 0.99; 95% CI 0.88, 1.11).|Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. The proportions losing \>2 cm of height during follow-up were compared using logistic models. Based on previous research by Siminoski et al., this degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity.(Siminoski K, Jiang G, Adachi JD, et al. Osteoporos Int 2005;16:403-410)||1.11|0.88|0.854
73964650|NCT02015520|147465038|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||||||0.38
73964651|NCT02015520|147465038|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73857705|NCT02308163|147260640|SUPERIORITY||LS Mean|-9.94|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-13.66|-6.22||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-6.22|-13.66|<0.001
73857706|NCT02308163|147260640|SUPERIORITY||Odds Ratio (OR)|-14.43|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-17.71|-11.15||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-11.15|-17.71|<0.001
73857707|NCT02308163|147260644|SUPERIORITY||LS mean|-8.69|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-12.19|-5.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-5.20|-12.19|<0.001
73857708|NCT02308163|147260644|SUPERIORITY||LS mean|-12.83|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-15.96|-9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.71|-15.96|<0.001
73857709|NCT02308163|147260646|SUPERIORITY||LS mean|-15.2|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|-21.4|-9.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.00|-21.40|<0.001
73857710|NCT02308163|147260646|SUPERIORITY||LS mean|-23.14|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-28.78|-17.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.51|-28.78|<0.001
73857711|NCT02308163|147260648|SUPERIORITY||LS mean|-16.88|STANDARD_ERROR_OF_MEAN|3.51|<|0.001|TWO_SIDED|95.0|-23.81|-9.95||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.95|-23.81|<0.001
73857712|NCT02308163|147260648|SUPERIORITY||LS mean|-23.56|STANDARD_ERROR_OF_MEAN|3.18|<|0.001|TWO_SIDED|95.0|-29.83|-17.28||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.28|-29.83|<0.001
73857713|NCT02308163|147260650|SUPERIORITY||LS mean|-17.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-24.36|-10.81||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.81|-24.36|<0.001
73964652|NCT02015520|147465038|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73964653|NCT05119855|147465047|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-concomitant Group. GMT Ratio is reported for Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.22|||||TWO_SIDED|95.0|0.92|1.61|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 6||1.61|0.92|
73964654|NCT05119855|147465047|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.33|||||TWO_SIDED|95.0|1.01|1.75|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 11||1.75|1.01|
74026210|NCT01009463|147605605|SUPERIORITY_OR_OTHER||Least squares mean difference|0.058|||<|0.001|TWO_SIDED|95.0|0.027|0.09||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.090|0.027|<0.001
73908897|NCT03693300|147347924|OTHER||Proportion (%)|6.0|||||TWO_SIDED|95.0|2.44|11.94|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||11.94|2.44|
73908898|NCT03693300|147347924|OTHER||Proportion (%)|4.4|||||TWO_SIDED|95.0|1.44|9.94|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||9.94|1.44|
73908899|NCT03693300|147347924|OTHER||Proportion (%)|0.0|||||TWO_SIDED|95.0|0.0|70.76|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||70.76|0.00|
73908900|NCT03693300|147347924|OTHER||Proportion (%)|4.3|||||TWO_SIDED|95.0|1.4|9.69|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||9.69|1.40|
73908901|NCT04195906|147347939|SUPERIORITY||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.328||0.877|TWO_SIDED|96.0|-2.46|3.0||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline BWAT-CUA score and visit by randomized treatment interaction.|MMRM|MMRM=Mixed model for repeated measures Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||3.00|-2.46|0.877
73908902|NCT04195906|147347940|SUPERIORITY||Least Squares Mean Difference|11.49|STANDARD_ERROR_OF_MEAN|7.93||0.146|TWO_SIDED|96.0|-4.8|27.78||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||27.78|-4.80|0.146
73908903|NCT04195906|147347941|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.237||0.706|TWO_SIDED|96.0|-0.38|0.56||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||0.56|-0.38|0.706
73908904|NCT04195906|147347942|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|2.63||0.995|TWO_SIDED|96.0|-5.27|5.24||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||5.24|-5.27|0.995
73908905|NCT04195906|147347943|SUPERIORITY||Odds Ratio, log|1.54|STANDARD_ERROR_OF_MEAN|0.498||0.384|TWO_SIDED|95.0|0.58|4.09||This model includes the stratification factor sodium thiosulfate use at baseline and the treatment as covariates|Regression, Logistic|As there is only a measure post-baseline, a logistic regression model was run instead of a generalized estimating equations model.|The odds ratio displayed is the odds ratio of having an improved result of SNF472 versus Placebo. The results 'Worsened', 'Equal', and 'Missing' are combined in one category and it is the reference for the odds ratio calculation.|||4.09|0.58|0.384
73908906|NCT04195906|147347944|SUPERIORITY||Difference in slopes between arms|0.57|STANDARD_ERROR_OF_MEAN|0.68||0.406|TWO_SIDED|95.0|-0.79|1.93||MMRM model includes fixed effect terms for randomized treatment, continuous variables maintenance opioid dose, Week (1 to 12) and Week by randomized treatment interaction. The random coefficients are the intercept and Week as a continuous variable.|MMRM|MMRM: mixed model repeated measures. An unstructured variance-covariance matrix is used||||1.93|-0.79|0.406
73908907|NCT01926015|147347955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Diphtheria Toxin \>=0.1 IU/mL||3.95|-3.99|<0.001
73908908|NCT01926015|147347955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Tetanus Toxin \>=0.01 IU/mL||3.95|-3.99|<0.001
73908909|NCT01926015|147347955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis Toxin \>=10 EU/mL||3.95|-3.99|<0.001
73908910|NCT01926015|147347955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis FHA \>=10 EU/mL||3.95|-3.99|<0.001
74026211|NCT01009463|147605605|SUPERIORITY_OR_OTHER||Least squares mean difference|0.064|||<|0.001|TWO_SIDED|95.0|0.033|0.096||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.096|0.033|<0.001
73908911|NCT01926015|147347955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 1 NA \>=8||3.95|-3.99|<0.001
73908912|NCT01926015|147347955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 2 NA \>=8||3.95|-3.99|<0.001
73908913|NCT01926015|147347955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 3 NA \>=8||3.95|-3.99|<0.001
73908914|NCT01364649|147347983|SUPERIORITY_OR_OTHER||LS mean difference|2.2|STANDARD_ERROR_OF_MEAN|0.9||0.013|TWO_SIDED|95.0|0.48|4.02|||Mixed Model Repeated Measurements|The primary analysis was performed by using observed case data only.||||4.02|0.48|0.013
73930952|NCT00280566|147391712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.32||0.1084|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1084
73964655|NCT05119855|147465047|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.36|||||TWO_SIDED|95.0|1.02|1.82|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 16||1.82|1.02|
73964656|NCT05119855|147465047|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.25|||||TWO_SIDED|95.0|0.92|1.7|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 18||1.70|0.92|
73964657|NCT05119855|147465047|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.21|||||TWO_SIDED|95.0|0.91|1.61|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 31||1.61|0.91|
73964658|NCT05119855|147465047|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.32|||||TWO_SIDED|95.0|0.98|1.77|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 33||1.77|0.98|
73964659|NCT05119855|147465047|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.4|||||TWO_SIDED|95.0|1.01|1.93|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 45||1.93|1.01|
73964660|NCT05119855|147465047|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.45|||||TWO_SIDED|95.0|1.13|1.87|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 52||1.87|1.13|
73964661|NCT05119855|147465047|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.2|||||TWO_SIDED|95.0|0.91|1.58|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 58||1.58|0.91|
73964662|NCT05119855|147465048|OTHER|Geometric Mean Concentration (GMC) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-SARS-CoV-2 concentrations and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMC Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Concentration (GMC) Ratio|1.17|||||TWO_SIDED|95.0|0.99|1.4|||||GMC Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Concentration (GMC) Ratio||1.40|0.99|
73964663|NCT02932579|147465055|SUPERIORITY||Mean Difference (Final Values)|13.0||||0.098|TWO_SIDED||||||t-test, 2 sided|||||||0.098
73964664|NCT02932579|147465056|SUPERIORITY||Risk Ratio (RR)|1.38||||0.74|TWO_SIDED|95.0|0.45|4.21|||Fisher Exact|||||4.21|0.45|0.740
73964665|NCT03201562|147465101|SUPERIORITY||Odds Ratio (OR)|38.436||||0.0009|TWO_SIDED|90.0|6.262|235.936|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect.||||235.936|6.262|0.0009
73964666|NCT03201562|147465101|SUPERIORITY||Odds Ratio (OR)|36.893||||0.0012|TWO_SIDED|90.0|5.936|229.31|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect.||||229.310|5.936|0.0012
74026212|NCT02333331|147605606|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.274|TWO_SIDED|95.0|-0.64|1.21|||Mixed Models Analysis|||||1.21|-0.64|0.274
73857714|NCT02308163|147260650|SUPERIORITY||LS mean|-23.9|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-30.24|-17.57||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.57|-30.24|<0.001
73857715|NCT02308163|147260652|SUPERIORITY|||||||0.033||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo||||0.033
73857716|NCT02308163|147260652|SUPERIORITY|||||||0.035||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo||||0.035
73857717|NCT02308163|147260653|SUPERIORITY||LS mean|-0.34|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.48|-0.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo||-0.20|-0.48|<0.001
73857718|NCT02308163|147260653|SUPERIORITY||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.53|-0.26||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo||-0.26|-0.53|<0.001
73857719|NCT02308163|147260655|SUPERIORITY||LS mean|6.87|STANDARD_ERROR_OF_MEAN|1.61|<|0.001|TWO_SIDED|95.0|3.69|10.05||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||10.05|3.69|<0.001
73908915|NCT05203289|147347992|OTHER||Ratio of geometric means (%)|101.88|||||TWO_SIDED|90.0|93.31|111.23|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 105.455."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||111.23|93.31|
73930953|NCT00280566|147391712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.27||0.038|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0380
73930954|NCT00280566|147391712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.35||0.2649|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2649
73964667|NCT03201562|147465101|SUPERIORITY||Odds Ratio (OR)|1.042||||0.9298|TWO_SIDED|90.0|0.485|2.239|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect||||2.239|0.485|0.9298
73857720|NCT02308163|147260655|SUPERIORITY||LS mean|6.98|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|4.11|9.85||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||9.85|4.11|<0.001
73857721|NCT02308163|147260657|SUPERIORITY||LS mean|2.89|STANDARD_ERROR_OF_MEAN|1.0||0.004|TWO_SIDED|95.0|0.91|4.87||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||4.87|0.91|0.004
73857722|NCT02308163|147260657|SUPERIORITY||LS mean|3.25|STANDARD_ERROR_OF_MEAN|0.98||0.001|TWO_SIDED|95.0|1.3|5.19||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.19|1.30|0.001
73857723|NCT02308163|147260659|SUPERIORITY||LS mean|2.27|STANDARD_ERROR_OF_MEAN|1.8||0.21|TWO_SIDED|95.0|-1.29|5.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.83|-1.29|0.210
73857724|NCT02308163|147260659|SUPERIORITY||LS mean|6.23|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|2.74|9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||9.71|2.74|<0.001
73857725|NCT02308163|147260661|SUPERIORITY||LS mean|-8.55|STANDARD_ERROR_OF_MEAN|3.81||0.027|TWO_SIDED|95.0|-16.11|-1.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.00|-16.11|0.027
73857726|NCT02308163|147260661|SUPERIORITY||LS mean|-10.17|STANDARD_ERROR_OF_MEAN|3.88||0.01|TWO_SIDED|95.0|-17.88|-2.47||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-2.47|-17.88|0.010
73857727|NCT02308163|147260663|SUPERIORITY||LS mean|-20.67|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|TWO_SIDED|95.0|-30.44|-10.89||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.89|-30.44|<0.001
73857728|NCT02308163|147260663|SUPERIORITY||LS mean|-22.01|STANDARD_ERROR_OF_MEAN|5.06|<|0.001|TWO_SIDED|95.0|-32.06|-11.97||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-11.97|-32.06|<0.001
73857729|NCT02308163|147260665|SUPERIORITY||LS mean|-20.22|STANDARD_ERROR_OF_MEAN|5.12|<|0.001|TWO_SIDED|95.0|-30.38|-10.06||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.06|-30.38|<0.001
73908916|NCT05203289|147347993|OTHER||Ratio of geometric means (%)|105.38|||||TWO_SIDED|90.0|95.06|116.81|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 106.431."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||116.81|95.06|
73908917|NCT05203289|147347994|OTHER||Ratio of geometric means (%)|91.29|||||TWO_SIDED|90.0|84.38|98.76|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 104.874."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||98.76|84.38|
73908918|NCT04066647|147348008|SUPERIORITY||Mean Difference (Final Values)|0.93928821||||0.9|TWO_SIDED||||||t-test, 2 sided|2 tailed, unpaired t test with Bonferroni correction||||||0.9
73908919|NCT01914757|147348011|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.002|TWO_SIDED|95.0|0.49|0.85|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.85|0.49|0.002
73908920|NCT01914757|147348011|SUPERIORITY_OR_OTHER||Rate Ratio|0.72||||0.019|TWO_SIDED|95.0|0.54|0.95|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.||||0.95|0.54|0.019
73908921|NCT01914757|147348012|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.015|TWO_SIDED|95.0|0.45|0.92|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.92|0.45|0.015
73908922|NCT01914757|147348012|SUPERIORITY_OR_OTHER||Rate Ratio|0.6||||0.005|TWO_SIDED|95.0|0.42|0.86|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.||||0.86|0.42|0.005
73908923|NCT01914757|147348013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.005|TWO_SIDED|95.0|0.037|0.213|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.213|0.037|0.005
73908924|NCT01914757|147348013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116||||0.01|TWO_SIDED|95.0|0.028|0.204|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.204|0.028|0.01
73964668|NCT00393484|147465102|NON_INFERIORITY_OR_EQUIVALENCE|The difference in proportion along with its standard error and 90% confidence interval was computed. If the lower limit of the confidence interval (CI) was great than -10%, noninferiority was established. Provided that noninferiority was established, a test for superiority was planned to check that the lower limit of the 90% CI was greater than zero.|Difference in proportion|25.67||||0.0006|TWO_SIDED|90.0|14.48|36.86||There was no adjustment for the prior test of noninferiority because the test for superiority could succeed only if noninferiority was first established.|Chi-squared|||A sample size of 60 per group provides 80% power for testing superiority of entecavir compared to lamivudine, assuming a response rate of 62% for lamivudine and 83% for entecavir.||36.86|14.48|0.0006
74026213|NCT02333331|147605606|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.32|TWO_SIDED|95.0|-0.83|1.35|||Mixed Models Analysis|||||1.35|-0.83|0.320
74026214|NCT02333331|147605606|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.134|TWO_SIDED|95.0|-0.24|0.87|||Mixed Models Analysis|||||0.87|-0.24|0.134
73908925|NCT01914757|147348014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.268|TWO_SIDED|95.0|-0.049|0.176|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.176|-0.049|0.268
73908926|NCT01914757|147348014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.786|TWO_SIDED|95.0|-0.127|0.096|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.096|-0.127|0.786
73908927|NCT01914757|147348015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.224|TWO_SIDED|95.0|-0.32|0.07|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.07|-0.32|0.224
73908928|NCT01914757|147348015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.019|TWO_SIDED|95.0|-0.43|-0.04|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||-0.04|-0.43|0.019
73908929|NCT01914757|147348016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.287|TWO_SIDED|95.0|-0.44|0.13|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.13|-0.44|0.287
73908930|NCT01914757|147348016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.966|TWO_SIDED|95.0|-0.28|0.29|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.29|-0.28|0.966
73908931|NCT01914757|147348017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.603|TWO_SIDED|95.0|-0.58|0.99|||Mixed Models Analysis|Model includes treatment, baseline Asthma rescue medication use, region, use of OCS, visit, and visit by treatment.||||0.99|-0.58|0.603
73908932|NCT01914757|147348017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.209|TWO_SIDED|95.0|-1.29|0.28|||Mixed Models Analysis|Model includes treatment, baseline Asthma medication use, region, use of OCS, visit, and visit by treatment.||||0.28|-1.29|0.209
73908933|NCT01914757|147348018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.86||||0.029|TWO_SIDED|95.0|1.59|30.12|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56||30.12|1.59|0.029
73908934|NCT01914757|147348018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.27||||0.037|TWO_SIDED|95.0|0.9|29.64|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56||29.64|0.9|0.037
74026215|NCT02333331|147605607|SUPERIORITY||Mean Difference (Final Values)|-3.32||||0.576|TWO_SIDED|95.0|-37.6|30.95|||Mixed Models Analysis|||||30.95|-37.6|0.576
73908935|NCT01914757|147348018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.54||||0.018|TWO_SIDED|95.0|3.07|32.0|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56||32|3.07|0.018
73908936|NCT01914757|147348018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.22||||0.004|TWO_SIDED|95.0|6.65|35.79|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56||35.79|6.65|0.004
73908937|NCT01914757|147348019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.4|TWO_SIDED|95.0|-0.06|0.03|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.||||0.03|-0.06|0.4
73908938|NCT01914757|147348019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.146|TWO_SIDED|95.0|-0.08|0.01|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.||||0.01|-0.08|0.146
73908939|NCT01914757|147348020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.043|TWO_SIDED|95.0|-0.38|-0.01|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||-0.01|-0.38|0.043
73908940|NCT01914757|147348020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.008|TWO_SIDED|95.0|-0.44|-0.07|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||-0.07|-0.44|0.008
73908941|NCT01914757|147348021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.078|TWO_SIDED|95.0|-0.51|0.03|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||0.03|-0.51|0.078
73908942|NCT01914757|147348021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.449|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||0.16|-0.37|0.449
73908943|NCT01914757|147348022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.31|0.69|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.69|0.31|<0.001
73908944|NCT01914757|147348022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.023|TWO_SIDED|95.0|0.45|0.95|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.95|0.45|0.023
73908945|NCT01914757|147348023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.46|0.8|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first Exacerbation||0.80|0.46|<0.001
73908946|NCT01914757|147348023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.018|TWO_SIDED|95.0|0.55|0.95|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first asthma exacerbation||0.95|0.55|0.018
73908947|NCT01914757|147348024|SUPERIORITY_OR_OTHER||Rate Ratio|0.93||||0.837|TWO_SIDED|95.0|0.48|1.82|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS||||1.82|0.48|0.837
73964669|NCT00393484|147465103|SUPERIORITY_OR_OTHER||Difference|24.55||||0.0003|TWO_SIDED|90.0|14.45|34.66||Treatment comparisons were assessed using the same method used in the primary endpoint.|Chi-squared|||HBV DNA \<10\^3 copies/mL at 24 Weeks||34.66|14.45|0.0003
73908948|NCT01914757|147348024|SUPERIORITY_OR_OTHER||Rate Ratio|1.23||||0.538|TWO_SIDED|95.0|0.64|2.35|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS||||2.35|0.64|0.538
73908949|NCT01914757|147348028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.119|TWO_SIDED|95.0|-0.04|0.37|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.||||0.37|-0.04|0.119
73908950|NCT01914757|147348028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.019|TWO_SIDED|95.0|0.04|0.45|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.||||0.45|0.04|0.019
73908951|NCT00333177|147348054|SUPERIORITY||||||<|0.03||||||P value is for CT-HBT X RLAI-Oral Ris interaction|ANCOVA|Covaried baseline value of dependent variable||A priori hypothesis was that CT would be superior to HBT and that RLAI would enhance this effect.||||<0.03
73908952|NCT00333177|147348055|SUPERIORITY||||||<|0.02||||||P-value is for each main effect. A priori threshold for statistical significance was p\<0.05 for each main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that LAI would be superior to oral risperidone and that CT would be superior to health behavior training (HBT) based on main effects.||||<.02
73908953|NCT00333177|147348056|SUPERIORITY||Mean Difference (Final Values)|0.84||||0.001|TWO_SIDED|95.0|0.57|1.1|||t-test, 2 sided|||A priori hypothesis was that RLAI would lead to less medication non-adherence than Oral Ris.||1.10|.57|.001
73908954|NCT00333177|147348057|SUPERIORITY||||||<|0.05||||||P-value is for CT vs. HBT main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.||||<.05
73908955|NCT00333177|147348058|SUPERIORITY|||||||0.55|||||||ANOVA|||||||0.55
73964670|NCT00393484|147465103|SUPERIORITY_OR_OTHER||Difference|13.62||||0.0167|TWO_SIDED|90.0|4.85|22.38||Treatment comparisons were assessed using the same method as the primary endpoint.|Chi-squared|||HBV DNA \<10\^4 copies/mL at 24 Weeks||22.38|4.85|0.0167
73964671|NCT00393484|147465103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.24||||0.4467|TWO_SIDED|90.0|-2.62|11.1|||Chi-squared|||HBV DNA \<10\^5 at 24 Weeks||11.10|-2.62|0.4467
73908956|NCT00333177|147348059|SUPERIORITY||||||<|0.02||||||A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.|ANOVA|2 X 2 ANOVA was computed.||||||<0.02
73908957|NCT00333177|147348060|SUPERIORITY||||||<|0.01|||||||Chi-squared|df = 1||Chi-square of frequencies of relapse vs. non-relapse were calculated, with a priori hypothesis that RLAI would be superior to Oral Ris.||||<0.01
73908958|NCT00333177|147348061|SUPERIORITY||||||<|0.05||||||2 X 2 ANOVA calculated. P-value is for main effect of RLAI vs. Oral Ris.|ANOVA|||||||<.05
73908959|NCT00333177|147348062|SUPERIORITY||||||<|0.02||||||2 X 2 ANOVA computed. P-value is for main effect of CT vs. HBT.|ANOVA|||||||<.02
73964672|NCT00393484|147465103|SUPERIORITY_OR_OTHER||Difference|26.12||||0.0002|TWO_SIDED|90.0|15.87|36.36|||Chi-squared|||HBV DNA \<10\^3 copies/mL at 48 Weeks||36.36|15.87|0.0002
73908960|NCT00333177|147348063|SUPERIORITY||||||=|0.053||||||2 X 2 ANOVA computed. P-value is for RLAI vs. Oral Ris main effect.|ANOVA|||||||=.053
73908961|NCT01426438|147348065|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.||||||0.28
73908962|NCT01426438|147348065|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.||||||0.19
73908963|NCT02833350|147348079|SUPERIORITY||Weighted difference|8.0||||0.2503|TWO_SIDED|95.0|-5.64|21.64|||Cochran-Mantel-Haenszel|||||21.64|-5.64|0.2503
73964673|NCT00393484|147465103|SUPERIORITY_OR_OTHER||Difference|20.09||||0.0009|TWO_SIDED|90.0|11.1|29.07|||Chi-squared|||HBV DNA \<10\^4 copies/mL at 48 Weeks||29.07|11.10|0.0009
74026216|NCT02333331|147605607|SUPERIORITY||Mean Difference (Final Values)|19.6||||0.178|TWO_SIDED|95.0|-22.2|61.41|||Mixed Models Analysis|||||61.41|-22.2|0.178
74026217|NCT02333331|147605607|SUPERIORITY||Mean Difference (Final Values)|10.31||||0.163|TWO_SIDED|95.0|-10.4|30.98|||Mixed Models Analysis|||||30.98|-10.4|0.163
74026218|NCT02333331|147605608|SUPERIORITY||Mean Difference (Net)|0.0||||0.488|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.10|-0.10|0.488
74026219|NCT02333331|147605608|SUPERIORITY||Mean Difference (Net)|0.1||||0.055|TWO_SIDED|95.0|-0.02|0.22|||Mixed Models Analysis|||||0.22|-0.02|0.055
74026220|NCT02333331|147605608|SUPERIORITY||Mean Difference (Net)|0.03||||0.161|TWO_SIDED|95.0|-0.03|0.09|||Mixed Models Analysis|||||0.09|-0.03|0.161
74026221|NCT02333331|147605609|SUPERIORITY||Mean Difference (Net)|1.01||||0.213|TWO_SIDED|95.0|0.99|1.03|||Mixed Models Analysis|||||1.03|0.99|0.213
74026222|NCT02333331|147605609|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.03|1.09|||Mixed Models Analysis|||||1.09|1.03|<0.001
74026223|NCT02333331|147605609|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.05|1.08|||Mixed Models Analysis|||||1.08|1.05|<0.001
73857730|NCT02308163|147260665|SUPERIORITY||LS mean|-23.67|STANDARD_ERROR_OF_MEAN|5.28|<|0.001|TWO_SIDED|95.0|-34.16|-13.17|||Covariance model|No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-13.17|-34.16|<0.001
73857731|NCT02308163|147260667|SUPERIORITY||LS mean|-17.3|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-24.0|-10.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.61|-24.00|<0.001
73908964|NCT02833350|147348079|SUPERIORITY||Weighted difference|12.93||||0.0164|TWO_SIDED|95.0|2.37|23.48|||Cochran-Mantel-Haenszel|||||23.48|2.37|0.0164
73908965|NCT02833350|147348079|SUPERIORITY||Weighted difference|20.0||||0.0003|TWO_SIDED|95.0|9.21|30.79|||Cochran-Mantel-Haenszel|||||30.79|9.21|0.0003
73964674|NCT00393484|147465103|SUPERIORITY_OR_OTHER||Difference|16.96||||0.0029|TWO_SIDED|90.0|8.43|25.5|||Chi-squared|||HBV DNA \<10\^5 at 48 Weeks||25.50|8.43|0.0029
74026224|NCT02333331|147605610|SUPERIORITY||Mean Difference (Net)|1.0||||0.458|TWO_SIDED|95.0|0.98|1.02|||Mixed Models Analysis|||||1.02|0.98|0.458
74026225|NCT02333331|147605610|SUPERIORITY||Mean Difference (Net)|1.05|||<|0.001|TWO_SIDED|95.0|1.03|1.08|||Mixed Models Analysis|||||1.08|1.03|<0.001
74026226|NCT02333331|147605610|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.04|1.07|||Mixed Models Analysis|||||1.07|1.04|<0.001
74026227|NCT01494038|147605611|NON_INFERIORITY|Calculate the difference between the immediate arm incidence rate and the deferred arm incidence rate; if the upper bound of the 95% confidence interval is lower than a 5% difference in incidence rates, non-inferiority will be considered to be proven.|Incidence rate difference|0.1|||||TWO_SIDED|95.0|-4.77|4.98||||||||4.98|-4.77|
74026228|NCT01494038|147605612|SUPERIORITY|||||||0.093|||||||Fisher Exact|mid-P adjustment||||||0.093
74026229|NCT01494038|147605614|SUPERIORITY|||||||0.288|||||||Fisher Exact|mid-P adjustment||||||0.288
74026230|NCT01494038|147605615|SUPERIORITY|||||||0.073|||||||Fisher Exact|mid-P adjustment||||||0.073
73908966|NCT02833350|147348081|SUPERIORITY||Weighted difference|-8.58||||0.1694|TWO_SIDED|95.0|-20.82|3.66|||Cochran-Mantel-Haenszel|||||3.66|-20.82|0.1694
73908967|NCT02833350|147348081|SUPERIORITY||Weighted difference|-1.5||||0.8132||95.0|-13.96|10.95|||Cochran-Mantel-Haenszel|||||10.95|-13.96|0.8132
73908968|NCT02833350|147348082|SUPERIORITY||Weighted difference|13.7||||0.0717|TWO_SIDED|95.0|-1.21|28.61|||Cochran-Mantel-Haenszel|||||28.61|-1.21|0.0717
73908969|NCT02833350|147348086|SUPERIORITY||adjusted difference|-0.11||||0.8504|TWO_SIDED|95.0|-0.45|0.23|||ANCOVA|||Week 1, Day 7||0.23|-0.45|0.8504
73908970|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.04||||0.9884|TWO_SIDED|95.0|-0.28|0.21|||ANCOVA|||At week 1, Day 7||0.21|-0.28|0.9884
73908971|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.06||||0.923|TWO_SIDED|95.0|-0.31|0.18|||ANCOVA|||Week 1 Day 7||0.18|-0.31|0.9230
73964675|NCT00393484|147465103|SUPERIORITY_OR_OTHER||Difference|35.27|||<|0.0001|TWO_SIDED|90.0|24.02|46.51|||Chi-squared|||HBV DNA \<10\^3 copies/mL at 96 Weeks||46.51|24.02|<0.0001
73964676|NCT00393484|147465103|SUPERIORITY_OR_OTHER||Difference|29.02|||<|0.0001|TWO_SIDED|90.0|18.07|39.97|||Chi-squared|||HBV DNA \<10\^4 copies/mL at 96 Weeks||39.97|18.07|<0.0001
74026231|NCT01494038|147605616|SUPERIORITY|||||||0.264|||||||Fisher Exact|mid-P adjustment||||||0.264
74026232|NCT01494038|147605617|SUPERIORITY|||||||0.012|||||||Fisher Exact|Mid-P adjustment||||||0.012
74026233|NCT01494038|147605620|SUPERIORITY|||||||0.279|||||||Fisher Exact|mid-P adjustment||||||0.279
74026234|NCT01494038|147605621|SUPERIORITY|||||||0.893|||||||Fisher Exact|mid-P adjustment||||||.893
74026235|NCT01494038|147605622|SUPERIORITY||Incidence rate difference|0.01|||||TWO_SIDED|95.0|-0.94|0.96||||||||0.96|-0.94|
74026236|NCT01494038|147605623|SUPERIORITY||Incidence rate difference|0.02|||||TWO_SIDED|95.0|-1.02|1.07||||||||1.07|-1.02|
74026237|NCT01494038|147605624|SUPERIORITY||Incidence rate difference|-1.43|||||TWO_SIDED|95.0|-4.17|1.32||||||||1.32|-4.17|
74026238|NCT01494038|147605625|SUPERIORITY||Incidence rate difference|-0.39|||||TWO_SIDED|95.0|-1.33|0.56||||||||0.56|-1.33|
74026239|NCT01494038|147605626|SUPERIORITY||Incidence rate difference|-0.38|||||TWO_SIDED|95.0|-1.72|0.97||||||||0.97|-1.72|
73908972|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.06||||0.9853|TWO_SIDED|95.0|-0.43|0.31|||ANCOVA|||Week 2, Day 14||0.31|-0.43|0.9853
74026240|NCT01494038|147605627|SUPERIORITY||Incidence rate difference|-1.69|||||TWO_SIDED|95.0|-4.48|1.1||||||||1.1|-4.48|
74026241|NCT01494038|147605628|SUPERIORITY||Incidence rate difference|-1.3|||||TWO_SIDED|95.0|-3.86|1.25||||||||1.25|-3.86|
74026242|NCT01494038|147605629|SUPERIORITY||Incidence rate difference|2.14|||||TWO_SIDED|95.0|-7.86|12.13||||||||12.13|-7.86|
74026243|NCT01494038|147605630|SUPERIORITY||Incidence rate difference|6.89|||||TWO_SIDED|95.0|-0.08|13.86||||||||13.86|-0.08|
74026244|NCT01494038|147605631|SUPERIORITY||Incidence rate difference|5.49|||||TWO_SIDED|95.0|-13.7|24.68||||||||24.68|-13.7|
74026245|NCT01494038|147605632|SUPERIORITY||Incidence rate difference|15.88|||||TWO_SIDED|95.0|2.11|29.65||||||||29.65|2.11|
74026246|NCT01494038|147605633|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
74026247|NCT01494038|147605634|SUPERIORITY||Incidence rate difference|3.38|||||TWO_SIDED|95.0|-1.31|8.07||||||||8.07|-1.31|
74026248|NCT01494038|147605635|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
74026249|NCT01494038|147605636|SUPERIORITY||Incidence rate difference|3.39|||||TWO_SIDED|95.0|-1.46|8.25||||||||8.25|-1.46|
74026250|NCT01494038|147605637|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
74026251|NCT01494038|147605638|SUPERIORITY||Incidence rate difference|3.38|||||TWO_SIDED|95.0|-1.31|8.07||||||||8.07|-1.31|
74026252|NCT01494038|147605639|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
74085227|NCT03008837|147724134|OTHER|Using seed-based analysis with a right posterior insula seed, cluster size was set at 40 voxels, and p-value was thresholded at p\<0.05 to compare the differences between the two groups in terms of connectivity between the right posterior insula and areas of the DMN identified based on a priori hypotheses.|Mean Difference (Final Values)|40.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided||Standard therapy control (post-pre) was subtracted from PENFS (post-pre).|PENFS (post-pre) - Standard Therapy (post-pre)||||<0.05
73857732|NCT02308163|147260667|SUPERIORITY||LS mean|-20.41|STANDARD_ERROR_OF_MEAN|3.13|<|0.001|TWO_SIDED|95.0|-26.59|-14.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-14.24|-26.59|<0.001
74026253|NCT01494038|147605640|SUPERIORITY||Incidence rate difference|3.39|||||TWO_SIDED|95.0|-1.46|8.25||||||||8.25|-1.46|
74026254|NCT01494038|147605645|OTHER|Measuring agreement between the tests|||||<|0.0001|||||||Chi-squared|McNemars test||||||< 0.0001
73857733|NCT02684058|147260671|SUPERIORITY|one-sided p-value at 2.5% level of significance|Odds Ratio (OR)|7.19|||<|0.001|TWO_SIDED|95.0|2.3|22.4|||Chi-squared|||||22.4|2.3|<0.001
73857734|NCT02684058|147260676|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.001|TWO_SIDED|95.0|0.17|0.55||Log-rank test at an overall one-sided 2.5% level of significance|Log Rank|||Up to approx. 3 years||0.55|0.17|<0.001
73857735|NCT01730339|147260726|SUPERIORITY_OR_OTHER||Least Square mean difference|0.68|STANDARD_ERROR_OF_MEAN|0.29||0.0219|TWO_SIDED|90.0|0.19|1.16|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||1.16|0.19|0.0219
73857736|NCT01730339|147260726|SUPERIORITY_OR_OTHER||Least Square mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.4038|TWO_SIDED|90.0|-0.24|0.72|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.72|-0.24|0.4038
73857737|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.43|0.2||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.20|-0.43|
73857738|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.43|0.11||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.11|-0.43|
73857739|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.15|0.52||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.15|
73857740|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.22|0.36||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.36|-0.22|
73857741|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|0.07|0.77||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.77|0.07|
73857742|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.05|0.65||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.65|0.05|
73857743|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.03|0.68||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.68|-0.03|
73857744|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.52||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.09|
73857745|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.18|0.42||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.18|
73908973|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.12||||0.6826|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 2, Day 14||0.15|-0.38|0.6826
73908974|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.18||||0.2634|TWO_SIDED|95.0|-0.45|0.08|||ANCOVA|||Week 2, Day 14||0.08|-0.45|0.2634
73908975|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.29||||0.2885|TWO_SIDED|95.0|-0.72|0.14|||ANCOVA|||Week 4, Day 28||0.14|-0.72|0.2885
73908976|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.3||||0.0598|TWO_SIDED|95.0|-0.61|0.01|||ANCOVA|||Week 4, Day 28||0.01|-0.61|0.0598
73908977|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.31||||0.044|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Week 4, Day 28||-0.01|-0.62|0.0440
73908978|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.28||||0.4271|TWO_SIDED|95.0|-0.76|0.2|||ANCOVA|||Week 8, Day 56||0.20|-0.76|0.4271
73908979|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.31||||0.0969|TWO_SIDED|95.0|-0.66|0.04|||ANCOVA|||Week 8, Day 56||0.04|-0.66|0.0969
73908980|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.33||||0.0612|TWO_SIDED|95.0|-0.68|0.01|||ANCOVA|||Week 8, Day 56||0.01|-0.68|0.0612
73908981|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.36||||0.2079|TWO_SIDED|95.0|-0.84|0.12|||ANCOVA|||Week 12, Day 84||0.12|-0.84|0.2079
73908982|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.57||||0.0003|TWO_SIDED|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84||-0.22|-0.92|0.0003
73908983|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.57||||0.0003|TWO_SIDED|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84||-0.22|-0.92|0.0003
73908984|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.34|0.82|||ANCOVA|||Week 1, Day 7||0.82|0.34|<.0001
73908985|NCT02833350|147348086|SUPERIORITY||Mean Difference (Net)|0.55|||<|0.0001|TWO_SIDED|95.0|0.31|0.8|||ANCOVA|||Week 1, Day 7||0.80|0.31|<0.0001
73908986|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.2|0.74|||ANCOVA|||Week 2, Day 14||0.74|0.20|<.0001
74026255|NCT01494038|147605645|OTHER|Agreement between tests|Kappa coefficient|0.42|||||TWO_SIDED|95.0|0.35|0.5||||||||0.50|0.35|
74026256|NCT01494038|147605646|OTHER|Agreement between tests||||||0.22|||||||Chi-squared|McNemar's test||||||0.22
74026257|NCT01494038|147605646|OTHER|Agreement between tests|Kappa coefficient|0.11|||||TWO_SIDED|95.0|0.001|0.21||||||||0.21|0.001|
74026258|NCT01494038|147605647|OTHER|Agreement between tests|||||<|0.0001|||||||Chi-squared|McNemar's test||||||< 0.0001
73908987|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|0.4||||0.0009|TWO_SIDED|95.0|0.13|0.66|||ANCOVA|||Week 2, Day 14||0.66|0.13|0.0009
73908988|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|0.56|||<|0.0001|TWO_SIDED|95.0|0.25|0.87|||ANCOVA|||Week 4, Day 28||0.87|0.25|<.0001
73908989|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|0.55|||<|0.0001|TWO_SIDED|95.0|0.24|0.85|||ANCOVA|||Week 4, Day 28||0.85|0.24|<.0001
74026259|NCT01494038|147605647|OTHER|Agreement between tests|Kappa coefficient|0.46|||||TWO_SIDED|95.0|0.39|0.53||||||||0.53|0.39|
74026260|NCT02874794|147605650|SUPERIORITY||Median Difference (Final Values)|-2.2||||0.7827|TWO_SIDED|95.0|-17.6|13.2|||ANCOVA|||||13.2|-17.6|0.7827
73908990|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|0.42||||0.0095|TWO_SIDED|95.0|0.08|0.76|||ANCOVA|||Week 8, Day 56||0.76|0.08|0.0095
73908991|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|0.4||||0.0153|TWO_SIDED|95.0|0.06|0.74|||ANCOVA|||Week 8, Day 56||0.74|0.06|0.0153
73908992|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|0.19||||0.4839|TWO_SIDED|95.0|-0.16|0.54|||ANCOVA|||Week 12, Day 84||0.54|-0.16|0.4839
73908993|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|0.19||||0.5035|TWO_SIDED|95.0|-0.16|0.53|||ANCOVA|||Week 12, Day 84||0.53|-0.16|0.5035
73908994|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.11||||0.4286|TWO_SIDED|95.0|-0.38|0.16|||ANCOVA|||Week 1, Day 7||0.16|-0.38|0.4286
73908995|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.2||||0.1831|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||Week 2, Day 14||0.10|-0.50|0.1831
73908996|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.31||||0.0667|TWO_SIDED|95.0|-0.65|0.02|||ANCOVA|||Week 4, Day 28||0.02|-0.65|0.0667
73908997|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.42|||ANCOVA|||Week 8, Day 56||-0.42|-1.11|<0.0001
73908998|NCT02833350|147348086|SUPERIORITY||Adjusted Difference|-0.76||||0.0002|TWO_SIDED|95.0|-1.15|-0.38|||ANCOVA|||Week 12, Day 84||-0.38|-1.15|0.0002
73908999|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.18||||0.5807|TWO_SIDED|95.0|-0.55|0.19|||ANCOVA|||Week 1, Day 7||0.19|-0.55|0.5807
73909000|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.12||||0.627|TWO_SIDED|95.0|-0.39|0.14|||ANCOVA|||Week 1, Day 7||0.14|-0.39|0.6270
73909001|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.15||||0.4475|TWO_SIDED|95.0|-0.42|0.12|||ANCOVA|||Week 1, Day 7||0.12|-0.42|0.4475
73909002|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.06||||0.9891|TWO_SIDED|95.0|-0.47|0.35|||ANCOVA|||Week 2, Day 14||0.35|-0.47|0.9891
73909003|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.21||||0.2244|TWO_SIDED|95.0|-0.51|0.08|||ANCOVA|||Week 2, Day 14||0.08|-0.51|0.2244
73909004|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.28||||0.0586|TWO_SIDED|95.0|-0.58|0.01|||ANCOVA|||Week 2, Day 14||0.01|-0.58|0.0586
73909005|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.39||||0.1338|TWO_SIDED|95.0|-0.85|0.08|||ANCOVA|||Week 4, Day 28||0.08|-0.85|0.1338
73909006|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.4||||0.0119|TWO_SIDED|95.0|-0.74|-0.07|||ANCOVA|||Week 4, Day 28||-0.07|-0.74|0.0119
73909007|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.44||||0.0046|TWO_SIDED|95.0|-0.77|-0.11|||ANCOVA|||Week 4, Day 28||-0.11|-0.77|0.0046
73909008|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.31||||0.3943|TWO_SIDED|95.0|-0.82|0.2|||ANCOVA|||Week 8, Day 56||0.20|-0.82|0.3943
74026261|NCT02874794|147605653|SUPERIORITY||Ratio of Geometric Means|0.6667|||<|0.0001|TWO_SIDED|95.0|0.5858|0.7589|||ANCOVA|||||0.7589|0.5858|<.0001
74026262|NCT02874794|147605654|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5792|TWO_SIDED|95.0|-0.58|0.33|||ANCOVA|||||0.33|-0.58|0.5792
74026263|NCT02874794|147605655|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.02|-1.59|||ANCOVA|||||-1.59|-4.02|<.0001
74026264|NCT02874794|147605656|SUPERIORITY||Median Difference (Final Values)|-0.03||||0.8617|TWO_SIDED|95.0|-0.33|0.27|||ANCOVA|||||0.27|-0.33|0.8617
74026265|NCT02874794|147605657|SUPERIORITY||Median Difference (Final Values)|-1.75||||0.0007|TWO_SIDED|95.0|-2.76|-0.75|||ANCOVA|||vs Enalapril||-0.75|-2.76|0.0007
74026266|NCT02874794|147605658|SUPERIORITY||Median Difference (Final Values)|0.63||||0.2354|TWO_SIDED|95.0|-0.41|1.68|||ANCOVA|||||1.68|-0.41|0.2354
74026267|NCT02874794|147605659|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8215|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||||0.04|-0.05|0.8215
74026268|NCT02874794|147605660|SUPERIORITY||Median Difference (Final Values)|-1.58||||0.0452|TWO_SIDED|95.0|-3.13|-0.03|||ANCOVA|||||-0.03|-3.13|0.0452
74026269|NCT02874794|147605661|SUPERIORITY||Mean Difference (Final Values)|-1.97||||0.0242|TWO_SIDED|95.0|-3.68|-0.26|||ANCOVA|||||-0.26|-3.68|0.0242
74026270|NCT00537940|147605662|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.8708|TWO_SIDED|95.0|-6.0|7.0|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between Baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.||7.0|-6.0|0.8708
74026271|NCT00537940|147605663|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.662|TWO_SIDED|95.0|0.635|1.335|||Regression, Logistic|||The odds ratio and its 95% CI are calculated by exponentiating the log odds ratio and 95% CI that correspond to the treatment contrast in the logistic regression model with treatment as fixed effect and Baseline term and country as covariate. All statistical tests for secondary efficacy parameters were two sided and performed at significance level of α = 0.05. The above statistical analysis applies to All Partial Seizures - FAS Population.||1.335|0.635|0.662
74026272|NCT00537940|147605664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9232|TWO_SIDED|||||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.9232
74085228|NCT01573533|147724161|SUPERIORITY|||||||0.49|||||||ANOVA|||Baseline vs 12 months||||0.49
74026273|NCT00537940|147605664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6361|TWO_SIDED|||||Simple Partial: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6361
74026274|NCT00537940|147605664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9075|TWO_SIDED|||||Complex partial: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.9075
74026275|NCT00537940|147605664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4203|TWO_SIDED|||||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.4203
74026276|NCT00537940|147605665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5069|TWO_SIDED|||||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.5069
74026277|NCT00537940|147605665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4721|TWO_SIDED|||||Simple partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.4721
74026278|NCT00537940|147605665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6054|TWO_SIDED|||||Complex partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6054
74026279|NCT00537940|147605665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6603|TWO_SIDED|||||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6603
74026280|NCT00537940|147605667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1881|TWO_SIDED|||||p-value is calculated using Fisher Exact Test.|Fisher Exact|||||||0.1881
74026281|NCT00537940|147605668|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.38||0.5643|TWO_SIDED|95.0|-0.53|0.97|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and and country as covariates.||0.97|-0.53|0.5643
74026282|NCT00537940|147605668|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.32||0.7712|TWO_SIDED|95.0|-0.73|0.54|||ANCOVA|||Change at Week 21 / ET , HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country as covariates.||0.54|-0.73|0.7712
74026283|NCT00537940|147605668|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.35||0.4236|TWO_SIDED|95.0|-0.41|0.97|||Ranked ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.97|-0.41|0.4236
74026284|NCT00537940|147605668|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.29||0.5492|TWO_SIDED|95.0|-0.75|0.4|||Ranked ANCOVA|||Change at Week 21/ET, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment1difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.40|-0.75|0.5492
74026285|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|2.07||0.116|TWO_SIDED|95.0|-0.81|7.31|||ANCOVA|||Baseline Sleep disturbance: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||7.31|-0.81|0.1160
74085229|NCT01573533|147724162|SUPERIORITY|||||||0.41|||||||ANOVA|||Baseline vs 12 months||||0.41
74085230|NCT01573533|147724163|SUPERIORITY|||||||0.06|||||||ANOVA|||Baseline vs 12 months||||0.06
74085231|NCT00809965|147724179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.72|0.97|||Log Rank||Based upon the Cox proportional hazards model|||0.97|0.72|0.020
74085232|NCT00809965|147724179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.028|TWO_SIDED|95.0|0.73|0.98|||Log Rank||Based upon the Cox proportional hazards model|||0.98|0.73|0.028
74026286|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.68||0.849|TWO_SIDED|95.0|-3.62|2.98|||ANCOVA|||Week 21 Sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.98|-3.62|0.8490
73909009|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.37||||0.0526|TWO_SIDED|95.0|-0.74|0.0|||ANCOVA|||Week 8, Day 56||0.00|-0.74|0.0526
73909010|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.39||||0.0365|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Week 8, Day 56||-0.02|-0.76|0.0365
73909011|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.41||||0.1696|TWO_SIDED|95.0|-0.93|0.11|||ANCOVA|||Week 12, Day 84||0.11|-0.93|0.1696
73909012|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.63||||0.0002|TWO_SIDED|95.0|-1.01|-0.25|||ANCOVA|||Week 12, Day 84||-0.25|-1.01|0.0002
73909013|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.62||||0.0003|TWO_SIDED|95.0|-1.0|-0.24|||ANCOVA|||Week 12, Day 84||-0.24|-1.00|0.0003
73909014|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|0.64|||<|0.0001|TWO_SIDED|95.0|0.37|0.9|||ANCOVA|||Week 1, Day 7||0.90|0.37|<0.0001
73909015|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|0.61|||<|0.0001|TWO_SIDED|95.0|0.34|0.88|||ANCOVA|||Week 1, Day 7||0.88|0.34|<0.0001
73909016|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|0.5||||0.0001|TWO_SIDED|95.0|0.21|0.79|||ANCOVA|||Week 2, Day 14||0.79|0.21|0.0001
73909017|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|0.43||||0.0012|TWO_SIDED|95.0|0.14|0.72|||ANCOVA|||Week 2, Day 14||0.72|0.14|0.0012
73909018|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.25|0.91|||ANCOVA|||Week 4, Day 28||0.91|0.25|<0.0001
73909019|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|0.54||||0.0002|TWO_SIDED|95.0|0.21|0.87|||ANCOVA|||Week 4, Day 28||0.87|0.21|0.0002
73964677|NCT00393484|147465103|SUPERIORITY_OR_OTHER||Difference|24.33||||0.0006|TWO_SIDED|90.0|13.71|34.95|||Chi-squared|||HBV DNA \<10\^5 copies/mL at 96 Weeks||34.95|13.71|0.0006
73909020|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|0.46||||0.0084|TWO_SIDED|95.0|0.09|0.82|||ANCOVA|||Week 8, Day 56||0.82|0.09|0.0084
73909021|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|0.44||||0.0124|TWO_SIDED|95.0|0.07|0.8|||ANCOVA|||Week 8, Day 56||0.80|0.07|0.0124
73909022|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|0.15||||0.7565|TWO_SIDED|95.0|-0.23|0.52|||ANCOVA|||Week 12, Day 84||0.52|-0.23|0.7565
73909023|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|0.16||||0.7158|TWO_SIDED|95.0|-0.22|0.53|||ANCOVA|||Week 12, Day 84||0.53|-0.22|0.7158
73909024|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.22||||0.1368|TWO_SIDED|95.0|-0.52|0.07|||ANCOVA|||Week 1, Day 7||0.07|-0.52|0.1368
73964678|NCT00393484|147465104|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariates of treatment and baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from baseline were based on patients with measurements at both Baseline and Week 24.||||<0.0001
73909025|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.28||||0.0974|TWO_SIDED|95.0|-0.62|0.05|||ANCOVA|||Week 2, Day 14||0.05|-0.62|0.0974
73909026|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.38||||0.0479|TWO_SIDED|95.0|-0.76|0.0|||ANCOVA|||Week 4, Day 28||-0.00|-0.76|0.0479
73909027|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.46|||ANCOVA|||Week 8, Day 56||-0.46|-1.22|<0.0001
73909028|NCT02833350|147348087|SUPERIORITY||Adjusted Difference|-0.83||||0.0001|TWO_SIDED|95.0|-1.24|-0.42|||ANCOVA|||Week 12, Day 84||-0.42|-1.24|0.0001
73909029|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.09||||0.9193|TWO_SIDED|95.0|-0.41|0.24|||ANCOVA|||Week 1, Day 7||0.24|-0.41|0.9193
73909030|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.1||||0.7062|TWO_SIDED|95.0|-0.33|0.14|||ANCOVA|||Week 1, Day 7||0.14|-0.33|0.7062
73909031|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.08||||0.8542|TWO_SIDED|95.0|-0.31|0.16|||ANCOVA|||Week 1, Day 7||0.16|-0.31|0.8542
73909032|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.13||||0.8095|TWO_SIDED|95.0|-0.51|0.24|||ANCOVA|||Week 2, Day 14||0.24|-0.51|0.8095
73909033|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.17||||0.3862|TWO_SIDED|95.0|-0.44|0.11|||ANCOVA|||Week 2, Day 14||0.11|-0.44|0.3862
73909034|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.16||||0.4328|TWO_SIDED|95.0|-0.43|0.12|||ANCOVA|||Week 2, Day 14||0.12|-0.43|0.4328
73909035|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.24||||0.4915|TWO_SIDED|95.0|-0.68|0.2|||ANCOVA|||Week 4, Day 28||0.20|-0.68|0.4915
73909036|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.26||||0.1441|TWO_SIDED|95.0|-0.58|0.06|||ANCOVA|||Week 4, Day 28||0.06|-0.58|0.1441
73909037|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.24||||0.189|TWO_SIDED|95.0|-0.56|0.07|||ANCOVA|||Week 4, Day 28||0.07|-0.56|0.1890
73909038|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.25||||0.5566|TWO_SIDED|95.0|-0.74|-0.24|||ANCOVA|||Week 8, Day 56||-0.24|-0.74|0.5566
73909039|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.32||||0.092|TWO_SIDED|95.0|-0.68|0.04|||ANCOVA|||Week 8, Day 56||0.04|-0.68|0.0920
73909040|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.29||||0.1391|TWO_SIDED|95.0|-0.65|0.06|||ANCOVA|||Week 8, Day 56||0.06|-0.65|0.1391
73909041|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.35||||0.2873|TWO_SIDED|95.0|-0.86|0.17|||ANCOVA|||Week 12, Day 84||0.17|-0.86|0.2873
73909042|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.54||||0.002|TWO_SIDED|95.0|-0.91|-0.16|||ANCOVA|||Week 12, Day 84||-0.16|-0.91|0.0020
74026287|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|1.19|STANDARD_ERROR_OF_MEAN|2.82||0.6728|TWO_SIDED|95.0|-4.34|6.73|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.73|-4.34|0.6728
74026288|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|2.3||0.3954|TWO_SIDED|95.0|-2.56|6.47|||ANCOVA|||Week 21 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.47|-2.56|0.3954
74026289|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|4.03|STANDARD_ERROR_OF_MEAN|2.52||0.1106|TWO_SIDED|95.0|-0.92|8.98|||ANCOVA|||Baseline Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||8.98|-0.92|0.1106
74026290|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.11||0.3603|TWO_SIDED|95.0|-6.09|2.22|||ANCOVA|||Week 21 Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.22|-6.09|0.3603
74085233|NCT00809965|147724180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.016|TWO_SIDED|95.0|0.72|0.97|||Log Rank||Based on the Cox proportional hazards model|||0.97|0.72|0.016
74085234|NCT00809965|147724180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.025|TWO_SIDED|95.0|0.73|0.98|||Log Rank||Based on the Cox proportional hazards model|||0.98|0.73|0.025
73857746|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.35|0.22||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.22|-0.35|
73857747|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.47|0.24||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.47|
73909043|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.54||||0.0016|TWO_SIDED|95.0|-0.92|-0.17|||ANCOVA|||Week 12, Day 84||-0.17|-0.92|0.0016
73857748|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.6|0.06||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.06|-0.60|
73857749|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.35|0.41||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.41|-0.35|
73909044|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|0.31||||0.005|TWO_SIDED|95.0|0.07|0.55|||ANCOVA|||Week 1, Day 7||0.55|0.07|0.0050
74026291|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8312|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Baseline Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||0.24|-0.30|0.8312
74026292|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9101|TWO_SIDED|95.0|-0.38|0.42|||ANCOVA|||Week 21 Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||0.42|-0.38|0.9101
74026293|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-2.37|STANDARD_ERROR_OF_MEAN|2.45||0.3346|TWO_SIDED|95.0|-7.19|2.45|||ANCOVA|||Baseline Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.45|-7.19|0.3346
74026294|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|2.05||0.7491|TWO_SIDED|95.0|-4.69|3.37|||ANCOVA|||Week 21 Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||3.37|-4.69|0.7491
74085235|NCT00809965|147724181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07|||Log Rank||Based upon the Cox proportional hazards model|||1.07|0.81|0.320
74085236|NCT00809965|147724181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.508|TWO_SIDED|95.0|0.83|1.1|||Log Rank||Based upon the Cox proportional hazards model|||1.10|0.83|0.508
74085237|NCT00809965|147724182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.185|TWO_SIDED|95.0|0.8|1.04|||Log Rank||Based upon the Cox proportional hazards model|||1.04|0.80|0.185
74085238|NCT00809965|147724182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.081|TWO_SIDED|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model|||1.01|0.78|0.081
74026295|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|1.9||0.1162|TWO_SIDED|95.0|-0.74|6.71|||ANCOVA|||Baseline Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.71|-0.74|0.1162
74026296|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|1.66||0.2163|TWO_SIDED|95.0|-1.21|5.32|||ANCOVA|||Week 21 Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||5.32|-1.21|0.2163
74026297|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|3.45|STANDARD_ERROR_OF_MEAN|1.61||0.0321|TWO_SIDED|95.0|0.3|6.61|||ANCOVA|||Baseline Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.61|0.30|0.0321
74026298|NCT00537940|147605669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|1.28||0.7889|TWO_SIDED|95.0|-2.17|2.85|||ANCOVA|||Week 21 Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.85|-2.17|0.7889
74026299|NCT00537940|147605670|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.653||||0.0252|TWO_SIDED|95.0|0.449|0.948|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||0.948|0.449|0.0252
73909045|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|0.33||||0.002|TWO_SIDED|95.0|0.1|0.57|||ANCOVA|||Week 1, Day 7||0.57|0.10|0.0020
73909046|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|0.35||||0.0082|TWO_SIDED|95.0|0.07|0.62|||ANCOVA|||Week 2, Day 14||0.62|0.07|0.0082
73909047|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|0.35||||0.0056|TWO_SIDED|95.0|0.08|0.63|||ANCOVA|||Week 2, Day 14||0.63|0.08|0.0056
73909048|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|0.5||||0.0004|TWO_SIDED|95.0|0.19|0.82|||ANCOVA|||Week 4, Day 28||0.82|0.19|0.0004
73909049|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|0.52||||0.0002|TWO_SIDED|95.0|0.21|0.84|||ANCOVA|||Week 4, Day 28||0.84|0.21|0.0002
73909050|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|0.34||||0.065|TWO_SIDED|95.0|-0.01|0.69|||ANCOVA|||Week 8, Day 56||0.69|-0.01|0.0650
73909051|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|0.37||||0.0365|TWO_SIDED|95.0|0.02|0.72|||ANCOVA|||Week 8, Day 56||0.72|0.02|0.0365
73909052|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|0.09||||0.9338|TWO_SIDED|95.0|-0.28|0.47|||ANCOVA|||Week 12, Day 84||0.47|-0.28|0.9338
73909053|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|0.09||||0.952|TWO_SIDED|95.0|-0.29|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.29|0.9520
73909054|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.19||||0.1496|TWO_SIDED|95.0|-0.45|0.07|||ANCOVA|||Week 1, Day 7||0.07|-0.45|0.1496
73909055|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.13||||0.3936|TWO_SIDED|95.0|-0.43|0.17|||ANCOVA|||Week 2, Day 14||0.17|-0.43|0.3936
74026300|NCT00537940|147605670|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.811||||0.3459|TWO_SIDED|95.0|0.524|1.254|||Regression, Logistic|||Week 21: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||1.254|0.524|0.3459
74026301|NCT05099991|147605700|NON_INFERIORITY|Non-inferiority would be demonstrated with a mean increase in procedure of 5 minutes.|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-7.8|8.2||||||||8.2|-7.8|
74026302|NCT05099991|147605701|OTHER|||||||0.07|||||||Fisher Exact|||||||0.07
74026303|NCT04243369|147605702|OTHER|Only descriptive statistics was provided. The rate and the exact 95% CI of the rate using the Clopper-Pearson Exact method is calculated.|Rate|100.0|||||TWO_SIDED|95.0|88.4|100.0||||||||100|88.4|
74026304|NCT00345605|147605710|SUPERIORITY_OR_OTHER||Slope|0.5|||||TWO_SIDED||||||||Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.|For sample size calculation, we used the means and standard deviation for PT, PTT. Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.||||
74026305|NCT01389128|147605732|OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
74026306|NCT01389128|147605735|OTHER|||||||0.68|||||||Chi-squared|||||||0.68
74026307|NCT01521845|147605738|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
74026308|NCT01521845|147605739|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
74026309|NCT01521845|147605740|SUPERIORITY_OR_OTHER|||||||1||95.0|||||not comparable|||||||1
74026310|NCT01532453|147605745|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED|||||Rank ANCOVA With treatment, center, gender, transplanted organ as factors and age of organ transplant as a covariable.|ANCOVA|||||||0.0278
74026311|NCT01532453|147605746|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579|||<|0.05|TWO_SIDED|95.0|0.2703|1.2405|||ANCOVA|||||1.2405|0.2703|<0.05
74026312|NCT01458340|147605747|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.69||0.6026|ONE_SIDED|95.0||3.2||α=0.05 significance level.|Mixed Model for Repeated Measures (MMRM)|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||3.2||0.6026
74026313|NCT01458340|147605747|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.69||0.4844|ONE_SIDED|95.0||2.7||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||2.7||0.4844
74085239|NCT00809965|147724183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.011|TWO_SIDED|95.0|0.73|0.96|||Log Rank||Based upon the Cox proportional hazards model|||0.96|0.73|0.011
74085240|NCT00809965|147724183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.07|TWO_SIDED|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model|||1.01|0.78|0.070
74085241|NCT02780167|147724184|OTHER||Estimate difference|1.8|STANDARD_ERROR_OF_MEAN|0.99||0.121|TWO_SIDED|95.0|-0.7|4.4|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.|||4.4|-0.7|0.1210
73857750|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.33|0.37||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.37|-0.33|
73857751|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.24|0.53||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.53|-0.24|
73857752|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.39|0.32||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.32|-0.39|
73857753|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.22|0.58||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.58|-0.22|
73857754|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.42|0.35||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.35|-0.42|
73857755|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.05|0.84||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.84|-0.05|
73909056|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.35||||0.0346|TWO_SIDED|95.0|-0.68|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.68|0.0346
73909057|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.68||||0.0004|TWO_SIDED|95.0|-1.04|-0.31|||ANCOVA|||Week 8, Day 56||-0.31|-1.04|0.0004
73909058|NCT02833350|147348088|SUPERIORITY||Adjusted Difference|-0.73||||0.0003|TWO_SIDED|95.0|-1.11|-0.34|||ANCOVA|||Week 12, Day 84||-0.34|-1.11|0.0003
73909059|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.17||||0.6083|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|||Week 1, Day 7||0.19|-0.53|0.6083
73909060|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.18||||0.2672|TWO_SIDED|95.0|-0.44|0.08|||ANCOVA|||Week 1, Day 7||0.08|-0.44|0.2672
73909061|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.17||||0.3158|TWO_SIDED|95.0|-0.43|0.09|||ANCOVA|||Week 1, Day 7||0.09|-0.43|0.3158
73909062|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.14||||0.8495|TWO_SIDED|95.0|-0.55|0.28|||ANCOVA|||Week 2, Day 14||0.28|-0.55|0.8495
73909063|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.28||||0.0856|TWO_SIDED|95.0|-0.58|0.03|||ANCOVA|||Week 2, Day 14||0.03|-0.58|0.0856
73909064|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.27||||0.1021|TWO_SIDED|95.0|-0.57|0.04|||ANCOVA|||Week 2, Day 14||0.04|-0.57|0.1021
73909065|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.33||||0.2762|TWO_SIDED|95.0|-0.82|0.15|||ANCOVA|||Week 4, Day 28||0.15|-0.82|0.2762
73857756|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.62|0.23||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.62|
73857757|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.94|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|0.4|1.49||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.49|0.40|
73857758|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.3|0.72||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.72|-0.30|
73857759|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.68|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.13|1.24||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.24|0.13|
73857760|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.38|0.67||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.38|
73909066|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.38||||0.0286|TWO_SIDED|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.73|0.0286
73909067|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.38||||0.0274|TWO_SIDED|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.73|0.0274
73909068|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.28||||0.4981|TWO_SIDED|95.0|-0.81|0.24|||ANCOVA|||Week 8, Day 56||0.24|-0.81|0.4981
73909069|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.39||||0.0472|TWO_SIDED|95.0|-0.78|0.0|||ANCOVA|||Week 8, Day 56||-0.00|-0.78|0.0472
73909070|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.36||||0.0753|TWO_SIDED|95.0|-0.75|0.03|||ANCOVA|||Week 8, Day 56||0.03|-0.75|0.0753
73909071|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.43||||0.1853|TWO_SIDED|95.0|-0.99|0.13|||ANCOVA|||Week 12, Day 84||0.13|-0.99|0.1853
73909072|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.62||||0.0009|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84||-0.21|-1.03|0.0009
73909073|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.62||||0.0008|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84||-0.21|-1.03|0.0008
73909074|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|0.41||||0.0005|TWO_SIDED|95.0|0.15|0.67|||ANCOVA|||Week 1, Day 7||0.67|0.15|0.0005
73909075|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|0.42||||0.0003|TWO_SIDED|95.0|0.16|0.68|||ANCOVA|||Week 1, Day 7||0.68|0.16|0.0003
73909076|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|0.39||||0.006|TWO_SIDED|95.0|0.09|0.69|||ANCOVA|||Week 2, Day 14||0.69|0.09|0.0060
73909077|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|0.4||||0.0039|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Week 2, Day 14||0.70|0.10|0.0039
73964679|NCT00393484|147465104|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 48.||||<0.0001
73964680|NCT00393484|147465104|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at 96 Weeks.||||<0.0001
73964681|NCT00393484|147465104|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 144.||||<0.0001
73964682|NCT00393484|147465104|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 192.||||<0.0001
73964683|NCT00393484|147465104|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 240.||||<0.0001
73964684|NCT00393484|147465106|SUPERIORITY_OR_OTHER||Difference|18.97||||0.0278|TWO_SIDED|90.0|5.22|32.73|||Chi-squared||At 24 Weeks|||32.73|5.22|0.0278
73964685|NCT00393484|147465106|SUPERIORITY_OR_OTHER||Difference|26.34||||0.0014|TWO_SIDED|90.0|13.65|39.03|||Chi-squared||At 48 Weeks|||39.03|13.65|0.0014
73964686|NCT00393484|147465106|SUPERIORITY_OR_OTHER||Difference|35.94|||<|0.0001|TWO_SIDED|90.0|23.35|48.52|||Chi-squared||At 96 Weeks|||48.52|23.35|<0.0001
73964687|NCT00393484|147465112|SUPERIORITY_OR_OTHER||Difference|33.71|||<|0.0001|TWO_SIDED|90.0|22.52|44.89|||Chi-squared||At 48 Weeks|||44.89|22.52|<0.0001
73857761|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.01|0.78||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.78|-0.01|
73857762|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.5|0.28||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.28|-0.50|
73857763|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.23|0.67||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.23|
73857764|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.63|0.24||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.63|
73857765|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.74|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|0.21|1.26||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.26|0.21|
73857766|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.41|0.59||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.59|-0.41|
73964688|NCT00393484|147465112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.21|||<|0.0001|TWO_SIDED|90.0|34.8|57.61|||Chi-squared||At 96 Weeks|||57.61|34.80|<0.0001
73964689|NCT00393484|147465112|SUPERIORITY_OR_OTHER||Difference|33.48||||0.0003|TWO_SIDED|90.0|19.31|47.65|||Chi-squared||At 144 Weeks|||47.65|19.31|0.0003
73964690|NCT00393484|147465112|SUPERIORITY_OR_OTHER||Difference|44.64|||<|0.0001|TWO_SIDED|90.0|31.17|58.11|||Chi-squared||At 192 Weeks|||58.11|31.17|<0.0001
73964691|NCT00393484|147465112|SUPERIORITY_OR_OTHER||Difference|52.23|||<|0.0001|TWO_SIDED|90.0|39.54|64.93|||Chi-squared||At 240 Weeks|||64.93|39.54|<0.0001
73964692|NCT00393484|147465113|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||Viral rebound at 96 weeks||||<0.0001
73964693|NCT04994509|147465142|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.042||p-value for rate ratio vs bHIV is from likelihood ratio test.|Likelihood ratio test||Confidence Interval (CI) for rate ratio vs bHIV is from a likelihood-based method.|Null Hypothesis 01: LEN/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than bHIV.||0.042|0.000|<0.0001
73964694|NCT04994509|147465142|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.042||p-value for rate ratio vs bHIV is from likelihood ratio test.|Likelihood ratio test||CI for rate ratio vs bHIV is based on a likelihood-based method.|Null Hypothesis 02: LEN/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly and at least 20% lower than bHIV.||0.042|0.000|<0.0001
73964695|NCT04994509|147465142|SUPERIORITY||Rate Ratio|0.839||||0.20697|TWO_SIDED|95.0|0.55|1.279||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 03: F/TAF/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in F/TAF was significantly lower than bHIV.||1.279|0.550|0.20697
73909078|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|0.53||||0.0007|TWO_SIDED|95.0|0.18|0.88|||ANCOVA|||Week 4, Day 28||0.88|0.18|0.0007
73909079|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|0.53||||0.0007|TWO_SIDED|95.0|0.19|0.88|||ANCOVA|||Week 4, Day 28||0.88|0.19|0.0007
73909080|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|0.39||||0.045|TWO_SIDED|95.0|0.01|0.77|||ANCOVA|||Week 8, Day 56||0.77|0.01|0.0450
74026314|NCT01458340|147605748|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|2.17||0.5269|ONE_SIDED|95.0||3.7||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||3.7||0.5269
73857767|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.02|1.02||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.02|0.02|
73857768|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.33|0.63||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.63|-0.33|
73857769|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.09|0.67||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.09|
73857770|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.39|0.34||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.34|-0.39|
73909081|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|0.42||||0.0259|TWO_SIDED|95.0|0.04|0.8|||ANCOVA|||Week 8, Day 56||0.80|0.04|0.0259
73909082|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|0.06||||0.9881|TWO_SIDED|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.34|0.9881
73909083|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|0.06||||0.9891|TWO_SIDED|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.34|0.9891
73909084|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.29||||0.0463|TWO_SIDED|95.0|-0.57|0.0|||ANCOVA|||Week 1, Day 7||-0.00|-0.57|0.0463
73909085|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.23||||0.1867|TWO_SIDED|95.0|-0.56|0.11|||ANCOVA|||Week 2, Day 14||0.11|-0.56|0.1867
73909086|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.44||||0.0213|TWO_SIDED|95.0|-0.81|-0.07|||ANCOVA|||Week 4, Day 28||-0.07|-0.81|0.0213
73909087|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.78||||0.0003|TWO_SIDED|95.0|-1.19|-0.37|||ANCOVA|||Week 8. Day 56||-0.37|-1.19|0.0003
73909088|NCT02833350|147348089|SUPERIORITY||Adjusted Difference|-0.82||||0.0002|TWO_SIDED|95.0|-1.24|-0.4|||ANCOVA|||Week 12, Day 84||-0.40|-1.24|0.0002
73909089|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
73909090|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
73909091|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|1.82||||0.3482|TWO_SIDED|95.0|-1.98|5.62|||Cochran-Mantel-Haenszel|||Week 1, Day 7||5.62|-1.98|0.3482
73909092|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 2, Day 14||5.71|-6.51|0.8979
73909093|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|-0.91||||0.5976|TWO_SIDED|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.48|-4.30|0.5976
73909094|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|0.91||||0.6546|TWO_SIDED|95.0|-3.07|4.89|||Cochran-Mantel-Haenszel|||Week 2, Day 14||4.89|-3.07|0.6546
73909095|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|-0.8||||0.7988|TWO_SIDED|95.0|-6.95|5.35|||Cochran-Mantel-Haenszel|||Week 4 Day 28||5.35|-6.95|0.7988
73909096|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|0.01||||0.9975|TWO_SIDED|95.0|-4.35|4.36|||Cochran-Mantel-Haenszel|||Week 4 Day 28||4.36|-4.35|0.9975
73909097|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|4.55||||0.1185|TWO_SIDED|95.0|-1.16|10.25|||Cochran-Mantel-Haenszel|||Week 4, Day 28||10.25|-1.16|0.1185
73909098|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|-2.4||||0.4765|TWO_SIDED|95.0|-9.01|4.21|||Cochran-Mantel-Haenszel|||Week 8, Day 56||4.21|-9.01|0.4765
73909099|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|4.61||||0.1655|TWO_SIDED|95.0|-1.9|11.12|||Cochran-Mantel-Haenszel|||Week 8, Day 56||11.12|-1.90|0.1655
73909100|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|8.18||||0.0234|TWO_SIDED|95.0|1.11|15.26|||Cochran-Mantel-Haenszel|||Week 8, Day 56||15.26|1.11|0.0234
73909101|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|3.2||||0.549|TWO_SIDED|95.0|-7.27|13.67|||Cochran-Mantel-Haenszel|||Week 12, Day 84||13.67|-7.27|0.5490
73909102|NCT02833350|147348090|SUPERIORITY||Mean Difference (Net)|15.62||||0.0003|TWO_SIDED|95.0|7.22|24.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84||24.03|7.22|0.0003
73909103|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|10.91||||0.0044|TWO_SIDED|95.0|3.39|18.43|||Cochran-Mantel-Haenszel|||Week 12, Day 84||18.43|3.39|0.0044
73909104|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|2.05||||0.6588|TWO_SIDED|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7||11.18|-7.07|0.6588
73909105|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|0.68||||0.8853|TWO_SIDED|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 2, Day 14||9.99|-8.62|0.8853
73909106|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
73909107|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|0.68||||0.8853|TWO_SIDED|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 8, Day 56||9.99|-8.62|0.8853
73909108|NCT02833350|147348090|SUPERIORITY||Adjusted Difference|11.64||||0.0584|TWO_SIDED|95.0|-0.41|23.7|||Cochran-Mantel-Haenszel|||Week 12, Day 84||23.70|-0.41|0.0584
74026315|NCT01458340|147605748|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.16||0.2092|ONE_SIDED|95.0||1.8||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||1.8||0.2092
74026316|NCT03230097|147605792|OTHER||Hazard Ratio (HR)|0.849||||0.7873|TWO_SIDED|95.0|0.258|2.795|||Regression, Cox|Stratified (by baseline use of antipsychotic medication) Cox proportional hazards model was used. Treatment effect and NAPLS risk score as covariates.|Ratio = BI 409306/placebo.|||2.795|0.258|0.7873
73909109|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
73909110|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.92|-2.92|1.0000
73909111|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.91|-2.91|1.0000
73909112|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
73909113|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
73909114|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 2, Day 14||4.28|-2.47|0.5976
73909115|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.71|-6.51|0.8979
73909116|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|-0.91||||0.5976|TWO_SIDED|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 4 Day 28||2.48|-4.30|0.5976
73909117|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|0.91||||0.6669|TWO_SIDED|95.0|-3.23|5.05|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.05|-3.23|0.6669
73909118|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|-1.6||||0.6309|TWO_SIDED|95.0|-8.13|4.93|||Cochran-Mantel-Haenszel|||Week 8, Day 56||4.93|-8.13|0.6309
73909119|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|1.83||||0.4473|TWO_SIDED|95.0|-2.9|6.56|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.56|-2.90|0.4473
73909120|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|2.73||||0.3021|TWO_SIDED|95.0|-2.45|7.91|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.91|-2.45|0.3021
73909121|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|-1.6||||0.7134|TWO_SIDED|95.0|-10.14|6.94|||Cochran-Mantel-Haenszel|||Week 12, Day 84||6.94|-10.14|0.7134
73909122|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|3.7||||0.2635|TWO_SIDED|95.0|-2.79|10.19|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.19|-2.79|0.2635
73909123|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|4.55||||0.1749|TWO_SIDED|95.0|-2.02|11.11|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.11|-2.02|0.1749
73909124|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|2.05||||0.6588|TWO_SIDED|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7||11.18|-7.07|0.6588
73909125|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2 Day 14||8.31|-8.31|1.0000
73909126|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.31|-8.31|1.0000
73909127|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.31|-8.31|1.0000
73964696|NCT04994509|147465142|SUPERIORITY||Rate Ratio|0.839||||0.58674|TWO_SIDED|95.0|0.55|1.279||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 04: F/TAF/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in F/TAF was significantly and at least 20% lower than bHIV.||1.279|0.550|0.58674
73964697|NCT04994509|147465143|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.101||p-value for rate ratio vs F/TDF is from an exact conditional Poisson model.|Poisson model||CI is from an exact conditional Poisson model.|||0.101|0.000|< 0.0001
73909128|NCT02833350|147348091|SUPERIORITY||Adjusted Difference|1.37||||0.7848|TWO_SIDED|95.0|-8.46|11.2|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.20|-8.46|0.7848
73909129|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.28|6.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.28|-6.28|1.0000
73909130|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.93||||0.5941|TWO_SIDED|95.0|-2.5|4.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.37|-2.50|0.5941
73909131|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.93|2.93|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.93|-2.93|1.0000
73909132|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.17|6.17|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.17|-6.17|1.0000
73909133|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.95|2.95|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.95|-2.95|1.0000
73909134|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
73909135|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|-0.43||||0.8929|TWO_SIDED|95.0|-6.62|5.77|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.77|-6.62|0.8929
73909136|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|-0.13||||0.9424|TWO_SIDED|95.0|-3.78|3.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28||3.51|-3.78|0.9424
73909137|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|-0.94||||0.5927|TWO_SIDED|95.0|-4.4|2.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28||2.51|-4.40|0.5927
73909138|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|-0.46||||0.8788|TWO_SIDED|95.0|-6.31|5.4|||Cochran-Mantel-Haenszel|||Week 8, Day 56||5.40|-6.31|0.8788
73909139|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.87||||0.6876|TWO_SIDED|95.0|-3.36|5.09|||Cochran-Mantel-Haenszel|||Week 8 Day 56||5.09|-3.36|0.6876
73909140|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.97||||0.6656|TWO_SIDED|95.0|-3.42|5.35|||Cochran-Mantel-Haenszel|||Week 8, Day 56||5.35|-3.42|0.6656
73909141|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|-0.46||||0.8787|TWO_SIDED|95.0|-6.34|5.42|||Cochran-Mantel-Haenszel|||Week 12 Day 84||5.42|-6.34|0.8787
73909142|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.74||||0.7101|TWO_SIDED|95.0|-3.17|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.66|-3.17|0.7101
73909143|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|3.2||||0.2425|TWO_SIDED|95.0|-2.16|8.55|||Cochran-Mantel-Haenszel|||Week 12, Day 84||8.55|-2.16|0.2425
73909144|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.68|8.68|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.68|-8.68|1.0000
73909145|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.39|8.39|||Cochran-Mantel-Haenszel|||Week 2 Day 14||8.39|-8.39|1.0000
73909146|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|2.03||||0.6658|TWO_SIDED|95.0|-7.17|11.22|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.22|-7.17|0.6658
74026317|NCT03230097|147605794|OTHER||Adjusted mean difference|1.77||||0.5212|TWO_SIDED|95.0|-3.773|7.315|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 24. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||7.315|-3.773|0.5212
74026318|NCT03230097|147605794|OTHER||Adjusted mean difference|3.18||||0.3127|TWO_SIDED|95.0|-3.071|9.425|||Mixed Models Analysis||Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM), see endpoint description for details.|BI 409306 vs. placebo of change from baseline at week 52. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||9.425|-3.071|0.3127
74026319|NCT03230097|147605795|OTHER||Adjusted mean difference|-4.99||||0.1602|TWO_SIDED|95.0|-12.033|2.057|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||2.057|-12.033|0.1602
74085242|NCT02780167|147724184|OTHER||Estimate difference|6.0|STANDARD_ERROR_OF_MEAN|3.05||0.1065|TWO_SIDED|95.0|-1.8|13.8|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 30 mg QD, Reference group: Placebo.|||13.8|-1.8|0.1065
74085243|NCT02780167|147724184|OTHER||Estimate difference|21.5|STANDARD_ERROR_OF_MEAN|6.25||0.0184|TWO_SIDED|95.0|5.5|37.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 100 mg QD, Reference group: Placebo.|||37.6|5.5|0.0184
73909147|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.77|8.77|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.77|-8.77|1.0000
73909148|NCT02833350|147348092|SUPERIORITY||Adjusted Difference|6.57||||0.2457|TWO_SIDED|95.0|-4.52|17.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||17.66|-4.52|0.2457
73909149|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-2.36||||0.496|TWO_SIDED|95.0|-6.73|2.02|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.02|-6.73|0.4960
73909150|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-2.18||||0.2736|TWO_SIDED|95.0|-5.34|0.98|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.98|-5.34|0.2736
73909151|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-3.08||||0.0608|TWO_SIDED|95.0|-6.26|0.1|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.10|-6.26|0.0608
73909152|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-1.25||||0.9237|TWO_SIDED|95.0|-6.02|3.52|||Cochran-Mantel-Haenszel|||Week 2, Day 14||3.52|-6.02|0.9237
73909153|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-3.14||||0.0893|TWO_SIDED|95.0|-6.6|0.33|||Cochran-Mantel-Haenszel|||Week 2, Day 14||0.33|-6.60|0.0893
73909154|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-4.07||||0.0138|TWO_SIDED|95.0|-7.51|-0.63|||Cochran-Mantel-Haenszel|||Week 2, Day 14||-0.63|-7.51|0.0138
73909155|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-3.22||||0.3358|TWO_SIDED|95.0|-8.24|1.8|||Cochran-Mantel-Haenszel|||Week 4, Day 28||1.80|-8.24|0.3358
73909156|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-4.57||||0.0078|TWO_SIDED|95.0|-8.2|-0.94|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-0.94|-8.20|0.0078
73909157|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-4.68||||0.0059|TWO_SIDED|95.0|-8.3|-1.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.06|-8.30|0.0059
73909158|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-2.29||||0.6503|TWO_SIDED|95.0|-7.39|2.8|||Cochran-Mantel-Haenszel|||Week 8, Day 56||2.80|-7.39|0.6503
73909159|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-3.12||||0.1282|TWO_SIDED|95.0|-6.84|0.59|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.59|-6.84|0.1282
73909160|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-2.94||||0.1675|TWO_SIDED|95.0|-6.65|0.78|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.78|-6.65|0.1675
73909161|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-2.94||||0.422|TWO_SIDED|95.0|-7.96|2.09|||Cochran-Mantel-Haenszel|||Week 12, Day 84||2.09|-7.96|0.4220
73909162|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-5.1||||0.0027|TWO_SIDED|95.0|-8.77|-1.42|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.42|-8.77|0.0027
73909163|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-5.47||||0.0011|TWO_SIDED|95.0|-9.15|-1.78|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.78|-9.15|0.0011
74026320|NCT03230097|147605796|OTHER||Adjusted mean difference|-0.8||||0.5858|TWO_SIDED|95.0|-3.749|2.153|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, positive items score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||2.153|-3.749|0.5858
74085244|NCT02780167|147724184|OTHER||Mean Difference (Final Values)|38.2|STANDARD_ERROR_OF_MEAN|7.18||0.0032|TWO_SIDED|95.0|19.7|56.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 200 mg QD, Reference group: Placebo.|||56.6|19.7|0.0032
74085245|NCT02780167|147724185|OTHER||LS mean difference|4.08|STANDARD_ERROR_OF_MEAN|9.667||0.6731|TWO_SIDED|90.0|-11.88|20.05|||Mixed Models Analysis|Mixed-effects model repeated measures (MMRM) with observed cases (OC)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.|||20.05|-11.88|0.6731
74085246|NCT02780167|147724185|OTHER||LS mean difference|-5.52|STANDARD_ERROR_OF_MEAN|9.474||0.561|TWO_SIDED|90.0|-21.16|10.13|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 30 mg QD, Reference group: Placebo.|||10.13|-21.16|0.5610
73909164|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|3.21||||0.0455|TWO_SIDED|95.0|0.05|6.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.37|0.05|0.0455
73909165|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|2.31||||0.2309|TWO_SIDED|95.0|-0.87|5.48|||Cochran-Mantel-Haenszel|||Week 1, Day 7||5.48|-0.87|0.2309
73909166|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|3.27||||0.0698|TWO_SIDED|95.0|-0.18|6.72|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.72|-0.18|0.0698
73909167|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|2.33||||0.2851|TWO_SIDED|95.0|-1.09|5.76|||Cochran-Mantel-Haenszel|||Week 2, Day 14||5.76|-1.09|0.2851
73909168|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|4.29||||0.0131|TWO_SIDED|95.0|0.69|7.9|||Cochran-Mantel-Haenszel|||Week 4, Day 28||7.90|0.69|0.0131
73909169|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|4.18||||0.0161|TWO_SIDED|95.0|0.59|7.78|||Cochran-Mantel-Haenszel|||Week 4, Day 28||7.78|0.59|0.0161
73964698|NCT04994509|147465143|SUPERIORITY||Rate Ratio|1.198||||0.7282|TWO_SIDED|95.0|0.669|2.143||p-value for rate ratio vs F/TDF is from a Poisson model.|Poisson model||CI is from a Poisson model.|||2.143|0.669|0.72820
74026321|NCT03230097|147605796|OTHER||Adjusted mean difference|1.43||||0.3445|TWO_SIDED|95.0|-1.604|4.462|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, negative items score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||4.462|-1.604|0.3445
74026322|NCT03230097|147605796|OTHER||Adjusted mean difference|1.71||||0.7154|TWO_SIDED|95.0|-7.772|11.196|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, total score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||11.196|-7.772|0.7154
74026323|NCT01165229|147605813|OTHER|The efficacy of Herpes Zoster subunit (HZ/su) vaccine against herpes zoster disease was demonstrated if the lower limit (LL) of the two-sided 95% Confidence Interval (CI) of VE was above 10%.|Vaccine efficacy|90.02|||<|0.0001|TWO_SIDED|95.0|83.54|94.32|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A 70-79 YOA group and Zoster-022 Placebo 70-79 YOA group.||94.32|83.54|<0.0001
73909170|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|3.85||||0.036|TWO_SIDED|95.0|0.18|7.51|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.51|0.18|0.0360
73909171|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|4.04||||0.0252|TWO_SIDED|95.0|0.37|7.7|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.70|0.37|0.0252
73909172|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|1.03||||0.9032|TWO_SIDED|95.0|-2.59|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.66|-2.59|0.9032
73909173|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|0.66||||0.9791|TWO_SIDED|95.0|-2.97|4.3|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.30|-2.97|0.9791
73909174|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-3.22||||0.0927|TWO_SIDED|95.0|-6.98|0.54|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.54|-6.98|0.0927
73909175|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-2.12||||0.3202|TWO_SIDED|95.0|-6.33|2.09|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.09|-6.33|0.3202
73909176|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-4.2||||0.0476|TWO_SIDED|95.0|-8.36|-0.04|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-0.04|-8.36|0.0476
73909177|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-9.93|||<|0.0001|TWO_SIDED|95.0|-14.31|-5.55|||Cochran-Mantel-Haenszel|||Week 8, Day 54||-5.55|-14.31|<0.0001
73909178|NCT02833350|147348093|SUPERIORITY||Adjusted Difference|-8.23||||0.0003|TWO_SIDED|95.0|-12.56|-3.9|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-3.90|-12.56|0.0003
73909179|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
73909180|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
73964699|NCT04994509|147465143|OTHER|Comparability to F/TDF is defined as the HIV-1 incidence in the LEN group at most 0.8/100 PY higher than in the F/TDF group.|Rate Difference|-1.685|||<|0.0001|TWO_SIDED|95.0|-2.737|-0.939||p-value for rate difference vs F/TDF is based on a hybrid approach.|Hybrid approach||Exact CI is based on a hybrid approach.|||-0.939|-2.737|<0.0001
73909181|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.28|-2.47|0.5976
73909182|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
73909183|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
74026324|NCT01165229|147605813|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.08|||<|0.0001|TWO_SIDED|95.0|74.65|96.16|||Poisson exact method|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo Zoster-022 Placebo \>=80YOA Group||96.16|74.65|<0.0001
74026325|NCT01165229|147605813|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.79|||<|0.0001|TWO_SIDED|95.0|84.29|93.66|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||93.66|84.29|<0.0001
74026326|NCT01165229|147605814|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|93.04|||<|0.0001|TWO_SIDED|95.0|72.47|99.19|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Post-Herpetic Neuralgia (PHN) between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group||99.19|72.47|<0.0001
74085247|NCT02780167|147724185|OTHER||LS mean difference|-23.82|STANDARD_ERROR_OF_MEAN|9.043||0.0091|TWO_SIDED|90.0|-38.76|-8.88|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 100 mg QD, Reference group: Placebo.|||-8.88|-38.76|0.0091
73909184|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.91|-2.91|1.0000
73909185|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||6.06|-6.06|1.0000
73909186|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.91||||0.5726|TWO_SIDED|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.09|-2.26|0.5726
73909187|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.28|-2.47|0.5976
73909188|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.06|-6.06|1.0000
73909189|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|2.74||||0.1446|TWO_SIDED|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.42|-0.94|0.1446
73964700|NCT04994509|147465143|OTHER|Comparability to F/TDF is defined as the HIV-1 incidence in the F/TAF group at most 0.8/100 PY higher than in the F/TDF group.|Rate Difference|0.333||||0.209|TWO_SIDED|95.0|-0.869|1.367||p-value for rate difference vs F/TDF is based on a hybrid approach.|Hybrid approach||Exact CI is based on a hybrid approach.|||1.367|-0.869|0.20900
73964701|NCT04994509|147465145|SUPERIORITY||Exact Odds Ratio|9.0||||0.0006|TWO_SIDED|95.0|2.06|83.36||p-value is from exact conditional logistic regression model.|ExactConditionalLogisticRegressionModel||Exact odds ratio and and CI are from exact conditional logistic regression model.|||83.36|2.06|0.0006
73909190|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|5.45||||0.0286|TWO_SIDED|95.0|0.57|10.34|||Cochran-Mantel-Haenszel|||Week 8, Day 56||10.34|0.57|0.0286
73909191|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.71|-6.51|0.8979
73909192|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|4.57||||0.0708|TWO_SIDED|95.0|-0.39|9.52|||Cochran-Mantel-Haenszel|||Week 12, Day 84||9.52|-0.39|0.0708
73909193|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|5.45||||0.0478|TWO_SIDED|95.0|0.05|10.86|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.86|0.05|0.0478
73909194|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.31|-8.31|1.0000
73964702|NCT01643070|147465160|SUPERIORITY||Odds Ratio (OR)|1.5||||0.719|TWO_SIDED|95.0|0.346|6.501|||t-test, 1 sided|||||6.501|0.346|0.719
73964703|NCT01600014|147465165|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.44||||0.001|TWO_SIDED|95.0|1.32|4.51||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included||4.51|1.32|0.001
73909195|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14||8.31|-8.31|1.0000
73909196|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
73909197|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|4.11||||0.3838|TWO_SIDED|95.0|-5.14|13.36|||Cochran-Mantel-Haenszel|||Week 8, Day 56||13.36|-5.14|0.3838
73964704|NCT01600014|147465165|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.37||||0.013|TWO_SIDED|95.0|1.07|5.25||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and week of randomisation||The analysis type was superiority between groups. In total 62 subjects were included||5.25|1.07|0.013
74026327|NCT01165229|147605814|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|71.16||||0.1844|TWO_SIDED|95.0|-51.51|97.08|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Group||97.08|-51.51|0.1844
73909198|NCT02833350|147348094|SUPERIORITY||Adjusted Difference|0.68||||0.9009|TWO_SIDED|95.0|-10.1|11.47|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.47|-10.10|0.9009
73909199|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-2.36||||0.5455|TWO_SIDED|95.0|-7.0|2.27|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.27|-7.00|0.5455
73909200|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-1.97||||0.4114|TWO_SIDED|95.0|-5.3|1.36|||Cochran-Mantel-Haenszel|||Week 1, Day 7||1.36|-5.30|0.4114
73909201|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-2.62||||0.1739|TWO_SIDED|95.0|-5.97|0.72|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.72|-5.97|0.1739
73909202|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-0.94||||0.9761|TWO_SIDED|95.0|-5.93|4.06|||Cochran-Mantel-Haenszel|||Week 2, Week 14||4.06|-5.93|0.9761
73909203|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-3.18||||0.0998|TWO_SIDED|95.0|-6.78|0.41|||Cochran-Mantel-Haenszel|||Week 2, Week 14||0.41|-6.78|0.0998
73909204|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-3.97||||0.0239|TWO_SIDED|95.0|-7.54|-0.39|||Cochran-Mantel-Haenszel|||Week 2, Week 14||-0.39|-7.54|0.0239
73909205|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-3.98||||0.2018|TWO_SIDED|95.0|-9.25|1.3|||Cochran-Mantel-Haenszel|||Week 4, Day 28||1.30|-9.25|0.2018
73909206|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-5.67||||0.0011|TWO_SIDED|95.0|-9.48|-1.87|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.87|-9.48|0.0011
73909207|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-5.27||||0.0026|TWO_SIDED|95.0|-9.06|-1.48|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.48|-9.06|0.0026
73909208|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-2.47||||0.6336|TWO_SIDED|95.0|-7.84|2.9|||Cochran-Mantel-Haenszel|||Week 8, Day 56||2.90|-7.84|0.6336
73909209|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-3.49||||0.095|TWO_SIDED|95.0|-7.38|0.41|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.41|-7.38|0.0950
73909210|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-3.18||||0.1451|TWO_SIDED|95.0|-7.06|0.71|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.71|-7.06|0.1451
73909211|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-3.28||||0.3434|TWO_SIDED|95.0|-8.43|1.87|||Cochran-Mantel-Haenszel|||Week 12, Day 84||1.87|-8.43|0.3434
73909212|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-5.45||||0.0016|TWO_SIDED|95.0|-9.23|-1.68|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.68|-9.23|0.0016
73909213|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-5.88||||0.0006|TWO_SIDED|95.0|-9.65|-2.1|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-2.10|-9.65|0.0006
73909214|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|4.64||||0.0025|TWO_SIDED|95.0|1.31|7.96|||Cochran-Mantel-Haenszel|||Week 1, Day 7||7.96|1.31|0.0025
74026328|NCT01165229|147605814|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|88.78|||<|0.0001|TWO_SIDED|95.0|68.7|97.1|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=70YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Group||97.10|68.70|<0.0001
74026329|NCT01165229|147605815|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.27|||<|0.0001|TWO_SIDED|95.0|86.04|94.85|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group||94.85|86.04|<0.0001
74026330|NCT01165229|147605815|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.37|||<|0.0001|TWO_SIDED|95.0|80.22|96.94|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Group||96.94|80.22|<0.0001
74026331|NCT01165229|147605815|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.3|||<|0.0001|TWO_SIDED|95.0|86.88|94.46|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Group||94.46|86.88|<0.0001
74026332|NCT01165229|147605816|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|90.8|||<|0.0001|TWO_SIDED|95.0|62.57|98.95|||Poisson exact test|||Comparison of of Vaccine Efficacy (VE) in prevention of PHN between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 placebo 70-79YOA Group||98.95|62.57|<0.0001
73909215|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|3.98||||0.0129|TWO_SIDED|95.0|0.64|7.32|||Cochran-Mantel-Haenszel|||Week 1, Day 7||7.32|0.64|0.0129
73909216|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|4.04||||0.0206|TWO_SIDED|95.0|0.46|7.62|||Cochran-Mantel-Haenszel|||Week 2, Day 14||7.62|0.46|0.0206
73909217|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|3.26||||0.0841|TWO_SIDED|95.0|-0.3|6.82|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.82|-0.30|0.0841
73909218|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|4.67||||0.0088|TWO_SIDED|95.0|0.91|8.42|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.42|0.91|0.0088
73909219|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|5.07||||0.0034|TWO_SIDED|95.0|1.34|8.81|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.81|1.34|0.0034
73909220|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|4.55||||0.0138|TWO_SIDED|95.0|0.71|8.39|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.39|0.71|0.0138
73909221|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|4.85||||0.0073|TWO_SIDED|95.0|1.02|8.69|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.69|1.02|0.0073
73909222|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|1.29||||0.8284|TWO_SIDED|95.0|-2.46|5.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.03|-2.46|0.8284
74026333|NCT01165229|147605816|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|65.76||||0.3072|TWO_SIDED|95.0|-91.58|96.62|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||96.62|-91.58|0.3072
74026334|NCT01165229|147605816|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|85.49|||<|0.0001|TWO_SIDED|95.0|58.52|96.3|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||96.30|58.52|<0.0001
74026335|NCT01165229|147605817|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|21.7||||0.3749|TWO_SIDED|95.0|-34.4|54.39|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||54.39|-34.40|0.3749
74026336|NCT01165229|147605817|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|51.76||||0.2466|TWO_SIDED|95.0|-65.55|85.95|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo\>=80YOA Group||85.95|-65.55|0.2466
74026337|NCT01165229|147605817|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|28.4||||0.1877|TWO_SIDED|95.0|-17.69|56.44|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo\>=70YOA Group||56.44|-17.69|0.1877
74026338|NCT01165229|147605820|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.2533|TWO_SIDED|95.0|-144.13|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||100.00|-144.13|0.2533
74085248|NCT02780167|147724185|OTHER||LS mean difference|-47.35|STANDARD_ERROR_OF_MEAN|9.008|<|0.0001|TWO_SIDED|90.0|-62.23|-32.47|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 200 mg QD, Reference group: Placebo.|||-32.47|-62.23|<0.0001
73909223|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|0.86||||0.9525|TWO_SIDED|95.0|-2.88|4.6|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.60|-2.88|0.9525
73909224|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-3.22||||0.0856|TWO_SIDED|95.0|-6.91|0.46|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.46|-6.91|0.0856
73909225|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-2.08||||0.3374|TWO_SIDED|95.0|-6.36|2.2|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.20|-6.36|0.3374
73909226|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-4.24||||0.0534|TWO_SIDED|95.0|-8.53|0.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||0.06|-8.53|0.0534
73964705|NCT01600014|147465166|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|4.41||||0.016|TWO_SIDED|95.0|1.1|17.62||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included||17.62|1.10|0.016
74085249|NCT03180801|147724260|OTHER|||||||0.03|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.||||0.03
73909227|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-10.8|||<|0.0001|TWO_SIDED|95.0|-15.33|-6.32|||Cochran-Mantel-Haenszel|||Week 8, Day 56||-6.32|-15.33|<0.0001
73909228|NCT02833350|147348095|SUPERIORITY||Adjusted Difference|-9.22|||<|0.0001|TWO_SIDED|95.0|-13.63|-4.81|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-4.81|-13.63|<0.0001
73909229|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
73909230|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
73909231|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.91|-2.91|1.0000
73909232|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
73909233|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
73964706|NCT01600014|147465166|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.24||||0.1|TWO_SIDED|95.0|0.78|6.47||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 62 subjects were included||6.47|0.78|0.10
73909234|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.91|-2.91|1.0000
73909235|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||6.06|-6.06|1.0000
73909236|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.91||||0.5726|TWO_SIDED|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.09|-2.26|0.5726
73909237|NCT02833350|147348096|SUPERIORITY||Mean Difference (Net)|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.28|-2.47|0.5976
73909238|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.06|-6.06|1.0000
73909239|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|2.74||||0.1446|TWO_SIDED|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.42|-0.94|0.1446
74085250|NCT03180801|147724260|OTHER|||||||0.07|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.||||0.07
73909240|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|3.64||||0.105|TWO_SIDED|95.0|-0.76|8.03|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.03|-0.76|0.1050
73909241|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.71|-6.51|0.8979
73909242|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|3.65||||0.127|TWO_SIDED|95.0|-1.04|8.35|||Cochran-Mantel-Haenszel|||Week 12, Day 84||8.35|-1.04|0.1270
73909243|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|5.45||||0.0501|TWO_SIDED|95.0|0.0|10.91|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.91|-0.00|0.0501
73909244|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.31|-8.31|1.0000
73909245|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14||8.31|-8.31|1.0000
73909246|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
73909247|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.31|-8.31|1.0000
73909248|NCT02833350|147348096|SUPERIORITY||Adjusted Difference|0.68||||0.9051|TWO_SIDED|95.0|-10.58|11.95|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.95|-10.58|0.9051
73909249|NCT01604408|147348122|SUPERIORITY_OR_OTHER||LS Mean Difference|0.426|||<|0.001|TWO_SIDED|95.0|0.192|0.66|||Mixed Model Repeated Measures|||||0.660|0.192|<0.001
73909250|NCT01604408|147348123|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.461||||0.073|TWO_SIDED|90.0|-0.883|-0.039|||Mixed Model Repeated Measures|||||-0.039|-0.883|0.073
73909251|NCT01604408|147348124|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.062||||0.191|TWO_SIDED|90.0|-2.4|0.276|||Mixed Model Repeated Measures|||||0.276|-2.400|0.191
74085251|NCT03180801|147724261|OTHER|One sided Fisher's exact test is used to test if TEAE rates of vaccine group is higher than the placebo group.||||||0.647|||||||Fisher Exact|||One sided Fisher's exact test is used to test if the TEAE rates pre-inoculation recorded for the treatment group are higher than for placebo.||||0.647
74085252|NCT03180801|147724261|OTHER|||||||1|||||||Fisher Exact|||One-sided Fisher's exact test is used to test if TEAE rate of vaccine group recorded pre-inoculation is higher than placebo.||||1.00
74085253|NCT03180801|147724261|OTHER|||||||0.024|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.||||0.0240
73909252|NCT01604408|147348125|SUPERIORITY_OR_OTHER||LS Mean Difference|0.017||||0.478|TWO_SIDED|90.0|-0.023|0.057|||Mixed Model Repeated Measures|||||0.057|-0.023|0.478
74085254|NCT03180801|147724261|OTHER|||||||0.186|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.||||0.186
73909253|NCT00074984|147348152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.1449|TWO_SIDED|95.0|0.269|1.222|||Log Rank|Comparison is based on a 2-sided log-rank test.||||1.222|0.269|0.1449
73909254|NCT00074984|147348152|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.465||||0.0577|TWO_SIDED|95.0|0.211|1.025|||Wald Test|||Time to First Primary Endpoint Adjusting for Baseline Proteinuria using Cox Proportional Hazards Model||1.025|0.211|0.0577
73909255|NCT00074984|147348153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732||||0.5261|TWO_SIDED|95.0|0.278|1.927|||Log Rank|2-sided log-rank test||Analysis of Time to First Renal Event for ITT population.||1.927|0.278|0.5261
73909256|NCT00694707|147348201|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.5||||0.0005|TWO_SIDED|95.0|-11.8|-3.3|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-3.3|-11.8|0.0005
73909257|NCT00694707|147348201|SUPERIORITY_OR_OTHER||Least squares mean difference|-8.8|||<|0.0001|TWO_SIDED|95.0|-13.1|-4.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-4.6|-13.1|<0.0001
73964707|NCT01600014|147465166|SUPERIORITY_OR_OTHER_LEGACY||Percent cleared subjects|50.0|||||TWO_SIDED|95.0|44.0|56.1|||||Estimation based on completers only.|Subjects randomised to vehicle were not included in the estimate of the overall clearance rate for the repeat-use regimen, from last treatment throught to Month 12. Instead, the subjects randomised to ingenol mebutate were given higher weights to reflect the hypothetical scenario where all randomised subjects were given active treatment during the repeat use cycle||56.1|44.0|
73909258|NCT00694707|147348201|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.4|||<|0.0001|TWO_SIDED|95.0|-14.6|-6.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-6.2|-14.6|<0.0001
74085255|NCT03180801|147724263|OTHER|||||||0.465|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom||||0.465
73909259|NCT00694707|147348201|SUPERIORITY_OR_OTHER||Least squares mean difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.4|-10.8|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-10.8|-19.4|<0.0001
73909260|NCT00694707|147348202|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.4||||0.004|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.1|-0.6|0.0040
73909261|NCT00694707|147348202|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.5||||0.0003|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.2|-0.7|0.0003
73909262|NCT00694707|147348202|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.4|-0.9|<0.0001
73909263|NCT00694707|147348202|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.6|-1.1|<0.0001
73909264|NCT01904058|147348207|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.28||||0.6603|TWO_SIDED|95.0|-12.59|8.03||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score evaluated by analysis of covariance (ANCOVA) using generalized linear model (GLM). The model included terms for treatment group, alkaline phosphatase (ALP) level (strata), treatment group by ALP level interaction and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95 percentage (%) confidence interval for mean were presented.||8.03|-12.59|0.6603
73909265|NCT01904058|147348207|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.99||||0.438|TWO_SIDED|95.0|-14.2|6.23||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score was evaluated by ANCOVA using a GLM. The model included terms for treatment group, ALP level (strata), treatment group by ALP level interaction, and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95% confidence interval for the mean, were presented.||6.23|-14.20|0.4380
73964708|NCT01600014|147465167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.38|-0.38||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using baseline observation carried forward (BOCF) as the imputation method.|The analysis type was superiority between groups. In total 141 subjects were included||-0.38|-1.38|<0.001
74085256|NCT03180801|147724263|OTHER|||||||0.074|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom||||0.074
74085257|NCT03180801|147724263|OTHER|||||||0.024|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms||||0.024
74085258|NCT03180801|147724263|OTHER|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms.||||0.230
74085259|NCT03180801|147724263|OTHER|||||||0.09|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding||||0.09
73909266|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.38||1|TWO_SIDED|95.0|-0.8|0.8|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.8|-0.8|1.000
73909267|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.37||1|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.7|-0.7|1.000
73909268|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.36||0.391|TWO_SIDED|95.0|-1.0|0.4|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.4|-1.0|0.391
73909269|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.696|TWO_SIDED|95.0|-0.6|0.9|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||0.9|-0.6|0.696
73909270|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.921|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis|||Relief: Intraparticipant analysis||0.8|-0.7|0.921
73909271|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.693|TWO_SIDED|95.0|-0.6|0.9|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.9|-0.6|0.693
73909272|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.39||0.77|TWO_SIDED|95.0|-0.7|0.9|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||0.9|-0.7|0.770
73909273|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.98||0.938|TWO_SIDED|95.0|-3.7|4.0|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||4.0|-3.7|0.938
73909274|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.52||0.34|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.5|-1.5|0.340
73909275|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.258|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.4|-1.6|0.258
73909276|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.49||0.381|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.5|-1.4|0.381
73909277|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.287|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||0.5|-1.6|0.287
73909278|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.42|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Relief: Intraparticipant analysis||0.6|-1.5|0.420
73964709|NCT01600014|147465167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.01|||<|0.001|TWO_SIDED|95.0|-1.52|-0.51||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Sensitivity analysis using complete cases|Sensitivity analysis using complete cases|The analysis type was superiority between groups. In total 141 subjects were included||-0.51|-1.52|<0.001
73964710|NCT01600014|147465167|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69||||0.008|TWO_SIDED|95.0|-1.19|-0.19||Formal statistical significance could not be established because of the closed test procedure where the first secondary endpoint tested (12 months clearance) did not reach statistical significance in the recurrent subgroup|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using BOCF as the imputation method, the difference in the adjusted mean AK count between the ingenol mebutate and vehicle groups|The analysis type was superiority between groups. In total 62 subjects were included||-0.19|-1.19|0.008
74085260|NCT03180801|147724263|OTHER|||||||0.22|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding||||0.22
74085261|NCT03180801|147724263|OTHER|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding||||0.23
74085262|NCT03180801|147724263|OTHER|||||||0.12|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding||||0.12
74026339|NCT01165229|147605820|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.5024|TWO_SIDED|95.0|-435.14|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||100.00|-435.14|0.5024
74026340|NCT01165229|147605820|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.0636|TWO_SIDED|95.0|-9.92|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||100.00|-9.92|0.0636
74026341|NCT01165229|147605821|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%.|Vaccine efficacy|-65.69||||0.4947|TWO_SIDED|95.0|-827.06|73.62|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||73.62|-827.06|0.4947
74026342|NCT01165229|147605821|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-558.05|100.0|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||100.00|-558.05|1.0000
73857771|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.12|0.74||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.74|-0.12|
73857772|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.76|0.05||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.05|-0.76|
73857773|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|0.25|1.2||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.20|0.25|
73857774|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.46|0.42||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.46|
73857775|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|0.01|1.05||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.05|0.01|
73857776|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.0|0.98||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.98|0.00|
73857777|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.29|0.62||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.62|-0.29|
73857778|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.28|0.43||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.43|-0.28|
73857779|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.02|1.0||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.00|0.02|
73857780|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.53|0.23||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.53|
73857781|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.08|1.2||||||Surface Area: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.20|0.08|
73857782|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.44|0.42||||||Surface Area : Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.44|
73857783|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.69|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|0.09|1.28||||||Surface Area: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.28|0.09|
73857784|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.23|0.69||||||Surface Area: week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.69|-0.23|
73857785|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.22||0.2778|TWO_SIDED|90.0|-0.12|0.6|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Week 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.60|-0.12|0.2778
73857786|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.22||0.6888|TWO_SIDED|90.0|-0.28|0.45|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.45|-0.28|0.6888
73909279|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53||0.227|TWO_SIDED|95.0|-1.7|0.4|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.4|-1.7|0.227
73909280|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.54||0.427|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||0.6|-1.5|0.427
73909281|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-3.1|STANDARD_ERROR_OF_MEAN|2.7||0.256|TWO_SIDED|95.0|-8.4|2.2|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||2.2|-8.4|0.256
73909282|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.62||0.198|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||2.0|-0.4|0.198
73909283|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|0.6||0.132|TWO_SIDED|95.0|-0.3|2.1|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||2.1|-0.3|0.132
73909284|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|0.58||0.227|TWO_SIDED|95.0|-0.4|1.8|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||1.8|-0.4|0.227
73909285|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.63||0.208|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||2.0|-0.4|0.208
73909286|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|0.63||0.265|TWO_SIDED|95.0|-0.5|1.9|||Mixed Models Analysis|||Relief: Intraparticipant analysis||1.9|-0.5|0.265
73909287|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.63||0.34|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||1.8|-0.6|0.340
74026343|NCT01165229|147605821|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|0.97||||1|TWO_SIDED|95.0|-433.32|83.16|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||83.16|-433.32|1.0000
73909288|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.64||0.347|TWO_SIDED|95.0|-0.7|1.9|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||1.9|-0.7|0.347
73909289|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|4.3|STANDARD_ERROR_OF_MEAN|3.19||0.179|TWO_SIDED|95.0|-2.0|10.6|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||10.6|-2.0|0.179
73909290|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|Least Square (LS) Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.57||0.556|TWO_SIDED|95.0|-1.4|0.8|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.8|-1.4|0.556
73909291|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.54||0.76|TWO_SIDED|95.0|-1.2|0.9|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.9|-1.2|0.760
73909292|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.53||0.636|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.8|-1.3|0.636
73909293|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.774|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||1.0|-1.3|0.774
74026344|NCT01165229|147605822|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|43.42||||0.0112|TWO_SIDED|95.0|10.77|70.53|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||70.53|10.77|0.0112
73909294|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.57||0.771|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||Relief: Intraparticipant analysis||1.0|-1.3|0.771
73909295|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.468|TWO_SIDED|95.0|-1.5|0.7|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.7|-1.5|0.468
73909296|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.58||0.886|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||1.1|-1.2|0.886
73964711|NCT03398148|147465168|SUPERIORITY||Adjusted Risk Difference|9.6||||0.0324|TWO_SIDED|90.0|2.2|17.0||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo)|||17.0|2.2|0.0324
73964712|NCT03398148|147465168|SUPERIORITY||Adjusted Risk Difference|8.4||||0.046|TWO_SIDED|90.0|1.5|15.3||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo)|||15.3|1.5|0.0460
73964713|NCT03398148|147465168|SUPERIORITY||Adjusted Risk Difference|8.7||||0.0397|TWO_SIDED|90.0|1.7|15.6||P-value ≤ 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo).|||15.6|1.7|0.0397
73964714|NCT03398148|147465169|SUPERIORITY||Adjusted Risk Difference|14.0|||<|0.0001|TWO_SIDED|95.0|10.0|18.0||Type I error rate control.|Cochran-Mantel-Haenszel|Stratified by Advanced Therapy-IR status (yes vs no), Baseline steroid use (yes vs. no) and Baseline Adapted Mayo Score (≤ 7, \> 7).||||18.0|10.0|<0.0001
73964715|NCT03398148|147465170|SUPERIORITY||Adjusted Risk Difference|18.7||||0.0028|TWO_SIDED|90.0|8.4|29.0||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||29.0|8.4|0.0028
73964716|NCT03398148|147465170|SUPERIORITY||Adjusted Risk Difference|8.4||||0.0968|TWO_SIDED|90.0|0.1|16.7||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||16.7|0.1|0.0968
73964717|NCT03398148|147465170|SUPERIORITY||Adjusted Risk Difference|10.5||||0.0512|TWO_SIDED|90.0|1.6|19.3||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||19.3|1.6|0.0512
74026345|NCT01165229|147605822|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of the VE was above 0%|Vaccine efficacy|27.03||||0.3903|TWO_SIDED|95.0|-26.43|73.2|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||73.20|-26.43|0.3903
74026346|NCT01165229|147605822|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|39.6||||0.0083|TWO_SIDED|95.0|10.79|64.75|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=70YOA group and Zoster-022 Placebo \>=70YOA Group||64.75|10.79|0.0083
74026347|NCT01165229|147605823|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|58.94||||0.0232|TWO_SIDED|95.0|11.45|80.96|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||80.96|11.45|0.0232
74026348|NCT01165229|147605823|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|-14.56||||0.8324|TWO_SIDED|95.0|-303.3|67.46|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||67.46|-303.30|0.8324
74026349|NCT01165229|147605823|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|49.25||||0.0404|TWO_SIDED|95.0|2.92|73.47|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||73.47|2.92|0.0404
74026350|NCT01165229|147605832|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.0081|TWO_SIDED|95.0|40.88|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 50-59YOA Group and Zoster-022/006 Pooled Placebo 50-59YOA Group.Comparison of vaccine efficacy for groups 70-79 and above 80 YOA are presented in outcome measure 2.||100.00|40.88|0.0081
74026351|NCT01165229|147605832|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.5097|TWO_SIDED|95.0|-442.83|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 60-69YOA Group and Zoster-022/006 Pooled Placebo 60-69YOA Group||100.00|-442.83|0.5097
74026352|NCT01165229|147605833|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-649.86|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group versus Zoster-022/006 Pooled Placebo 50-59 YOA Group||100.00|-649.86|1.0000
74026353|NCT01165229|147605833|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-3938.7|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group versus Zoster-022/006 Pooled Placebo 60-69 YOA Group||100.00|-3938.70|1.0000
74026354|NCT01165229|147605833|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|21.6||||1|TWO_SIDED|95.0|-149.41|78.91|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group versus Zoster-022/006 Pooled Placebo 70-79 YOA Group||78.91|-149.41|1.0000
73909297|NCT01346969|147348305|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|2.91||0.668|TWO_SIDED|95.0|-7.0|4.5|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||4.5|-7.0|0.668
73909298|NCT05736224|147348328|SUPERIORITY|||||||0.003||||||No sunscreen compared to test sunscreen|t-test, 2 sided|||||||0.003
73909299|NCT03319173|147348342|OTHER||Mean Difference (Final Values)|8.24|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|7.79|8.7|||Regression, Linear|||||8.7|7.79|<0.0001
73909300|NCT03319173|147348343|OTHER||Estimate|0.35|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.31|0.39|||Regression, Linear|||||0.39|0.31|<0.0001
73909301|NCT03319173|147348344|OTHER||Estimate|0.46|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.41|0.52|||Regression, Linear|||||0.52|0.41|<0.0001
73909302|NCT03319173|147348345|OTHER||Estimate|0.514|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.47|0.56|||Regression, Linear|||||0.56|0.47|<0.0001
73909303|NCT03319173|147348346|OTHER||Estimate|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.4|0.49|||Regression, Linear|||||0.49|0.40|<0.0001
73964718|NCT03398148|147465172|SUPERIORITY||Adjusted Risk Difference|23.9||||0.0022|TWO_SIDED|90.0|11.0|36.7||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||36.7|11.0|0.0022
73909304|NCT03319173|147348347|OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.4|0.49|||Estimate|||||0.49|0.40|<0.0001
74026355|NCT01165229|147605833|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|-223.81||||0.1528|TWO_SIDED|95.0|-883.05|18.84|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=80 YOA Group versus Zoster-022/006 Pooled Placebo\>=80 YOA Group||18.84|-883.05|0.1528
73964719|NCT03398148|147465172|SUPERIORITY||Adjusted Risk Difference|28.4||||0.0002|TWO_SIDED|90.0|15.7|41.1||P-value ≤ 0.001|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||41.1|15.7|0.0002
73964720|NCT03398148|147465172|SUPERIORITY||Adjusted Risk Difference|33.8|||<|0.0001|TWO_SIDED|90.0|20.7|46.9||P-value ≤ 0.001|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||46.9|20.7|<0.0001
73964721|NCT03398148|147465173|SUPERIORITY||Adjusted Risk Difference|10.2||||0.1842|TWO_SIDED|90.0|-2.4|22.9|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||22.9|-2.4|0.1842
73964722|NCT03398148|147465173|SUPERIORITY||Adjusted Risk Difference|23.2||||0.0041|TWO_SIDED|90.0|9.9|36.4||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||36.4|9.9|0.0041
74026356|NCT01165229|147605833|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|0.29||||0.5417|TWO_SIDED|95.0|-161.53|65.57|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=50 YOA Group versus Zoster-022/006 Pooled Placebo \>=50 YOA Group||65.57|-161.53|0.5417
74026357|NCT01165229|147605834|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|23.75||||0.2885|TWO_SIDED|95.0|-25.8|53.78|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A 70-79YOA Group and Zoster-022/006 pooled Placebo 70-79YOA Group||53.78|-25.80|0.2885
74026358|NCT01165229|147605834|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|54.93||||0.194|TWO_SIDED|95.0|-50.03|86.46|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=80 YOA Group and Zoster-022/006 pooled Placebo \>=80 YOA Group||86.46|-50.03|0.1940
73964723|NCT03398148|147465173|SUPERIORITY||Adjusted Risk Difference|13.1||||0.1117|TWO_SIDED|90.0|-0.4|26.6|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||26.6|-0.4|0.1117
74026359|NCT01165229|147605834|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|30.48||||0.1243|TWO_SIDED|95.0|-10.52|56.27|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 pooled Placebo\>=70 YOA Group||56.27|-10.52|0.1243
74026360|NCT00095303|147605857|SUPERIORITY_OR_OTHER||slope of linear trajectory of drug use|0.05||||0.27|TWO_SIDED|95.0|-0.04|0.14|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of the BSFT treatment assignment and the linear time trend.|Null Hypothesis: BSFT will be significantly more effective than TAU in reducing adolescent drug abuse, defined as the percentage of drug use days in 28-day periods. The outcome variable is the percentage of days of drug use within a 28-day period. This variable constructed from the Timeline-Follow-back instrument and measured as the sum of the number of days with positive use in 28-day increments. Hypothesis tested using hierarchical linear models.||.14|-.04|.27
73909305|NCT03319173|147348348|OTHER||Estimate|0.75|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.72|0.78|||Regression, Linear|||||0.78|0.72|<0.0001
73909306|NCT03319173|147348349|OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.3|0.37|||Estimate|||||0.37|0.30|<0.0001
73909307|NCT03319173|147348350|OTHER||Estimate|0.87|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.85|0.88|||Regression, Linear|||||0.88|0.85|<0.0001
73909308|NCT03319173|147348351|OTHER||Estimate|0.87|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.85|0.88|||Regression, Linear|||||0.88|0.85|<0.0001
73909309|NCT03319173|147348352|OTHER||Estimate|0.75|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.71|0.8|||Regression, Linear|||||0.80|0.71|<0.0001
73909310|NCT03319173|147348353|OTHER||Estimate|0.51|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.47|0.56|||Regression, Linear|||||0.56|0.47|<0.0001
73909311|NCT03319173|147348354|OTHER||Estimate|1.13|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|1.104|1.156|||Regression, Linear|||||1.156|1.104|<0.0001
73909312|NCT03319173|147348355|OTHER||Estimate|1.037|||<|0.0001|TWO_SIDED|95.0|1.025|1.049|||Regression, Linear|||||1.049|1.025|<0.0001
73909313|NCT03319173|147348356|OTHER||Estimate|0.93|STANDARD_ERROR_OF_MEAN|0.008|<|0.0001|TWO_SIDED|95.0|0.91|0.94|||Regression, Linear|||||0.94|0.91|<0.0001
73909314|NCT03319173|147348357|OTHER||Estimate|1.122|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|1.096|1.149|||Regression, Linear|||||1.149|1.096|<0.0001
74026361|NCT00095303|147605859|SUPERIORITY_OR_OTHER||Slope|-0.1||||0.26|TWO_SIDED|95.0|-0.28|0.08|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in decreasing adolescent externalizing problem behaviors||0.08|-0.28|.26
74085263|NCT03180801|147724264|OTHER|||||||0.0501|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.||||0.0501
73909315|NCT03673046|147348358|SUPERIORITY||Mean Difference (Final Values)|-10.1255|STANDARD_ERROR_OF_MEAN|1.5705|<|0.0001|TWO_SIDED|95.0|-13.2532|-6.9978||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-eeek waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in BDD-YBOCS total scores between the treatment groups at endpoint (week 12).||-6.9978|-13.2532|<.0001
73909316|NCT03673046|147348359|SUPERIORITY||Mean Difference (Final Values)|-3.2648|STANDARD_ERROR_OF_MEAN|1.0346||0.0023|TWO_SIDED|95.0|-5.3275|-1.2022||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an auto-correlation with heterogeneous variance (ARH(1)) covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in QIDS-SR total scores between the treatment groups at endpoint (week 12).||-1.2022|-5.3275|0.0023
74085264|NCT03180801|147724264|OTHER|||||||0.3139|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.||||0.3139
73909317|NCT03673046|147348360|SUPERIORITY||Mean Difference (Final Values)|-4.8412|STANDARD_ERROR_OF_MEAN|1.1195|<|0.0001|TWO_SIDED|95.0|-7.0698|-2.6126||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in BABS total scores between the treatment groups at endpoint (week 12).||-2.6126|-7.0698|<.0001
73909318|NCT03673046|147348361|SUPERIORITY||Mean Difference (Final Values)|-5.8847|STANDARD_ERROR_OF_MEAN|1.676||0.0008|TWO_SIDED|95.0|-9.2237|-2.5458||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an auto-correlation with heterogeneous variance (ARH(1)) covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in SDS total scores between the treatment groups at endpoint (week 12).||-2.5458|-9.2237|.0008
73909319|NCT03673046|147348362|SUPERIORITY||Mean Difference (Final Values)|11.7529|STANDARD_ERROR_OF_MEAN|3.4553||0.0011|TWO_SIDED|95.0|4.863|18.6428||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in Q-LESQ-SF total scores between the treatment groups at endpoint (week 12).||18.6428|4.8630|.0011
74085265|NCT03180801|147724265|OTHER|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has smaller shedding AUC than placebo.||||0.102
74085266|NCT03180801|147724265|OTHER|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has a smaller shedding AUC than placebo.||||0.481
74026362|NCT00095303|147605875|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.21|TWO_SIDED|95.0|0.82|1.09|||GEE|||Null Hypothesis: BSFT will be significantly more effective than TAU in the rates of drug use, defined as the percentage of drug use days in last 90 days. The primary hypothesis will be evaluated in terms of % of days of drug use in the last 90 days, assessed by the timeline follow-back. The general analytic approach will use generalized estimating equation (GEE) with negative binomial distribution comparing the BSFT and TAU participants||1.09|.82|.21
74026363|NCT00095303|147605877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.006|TWO_SIDED|95.0|-0.71|-0.12|||GEE|||Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in the level of externalizing problem behaviors||-.12|-.71|<.006
74026364|NCT00095303|147605878|SUPERIORITY_OR_OTHER||Slope|0.12||||0.015|TWO_SIDED|95.0|0.03|0.22|||Mixed Models Analysis|||Null hypothesis: BSFT will be significantly more effective than TAU in improving family functioning.The four components of the 'Parenting Practices Inventory' will be used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. Hypothesis will be analyzed as using hierarchical linear models.||.22|.03|.015
73909320|NCT01896050|147348371|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Compare difference in change in body mass index between baseline and 12 months between aromatase inhibitor- and tamoxifen-treated patients||||0.03
73909321|NCT01896050|147348371|SUPERIORITY_OR_OTHER||BMI squared|-0.01845|STANDARD_ERROR_OF_MEAN|0.02308||0.4262|TWO_SIDED||||||Regression, Linear|||Examine association between change in body mass index and change in grip strength with aromatase inhibitor therapy. For the primary outcome, linear regression was used for analysis with change of grip strength as response variable. In the original statistical analysis plan only aromatase inhibitor-treated patients were to be included in this analysis. This analysis was not performed on the tamoxifen group because it isn't clinically relevant.||||0.4262
73909322|NCT01896050|147348372|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in maximum grip strength between baseline and 12 months for aromatase inhibitor-treated versus tamoxifen-treated patients||||0.032
73909323|NCT01896050|147348373|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.92|1.04||||||Association between baseline body mass index and discontinuation of aromatase inhibitor therapy. The original statistical analysis plan only called for analyzing the aromatase inhibitor-treated patients, not the tamoxifen-treated patients.||1.04|0.92|
73909324|NCT00866788|147348398|SUPERIORITY_OR_OTHER|||||||0.1601||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1601
73909325|NCT00866788|147348398|SUPERIORITY_OR_OTHER|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0003
73909326|NCT00866788|147348398|SUPERIORITY_OR_OTHER|||||||0.0473||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0473
73909327|NCT00866788|147348399|SUPERIORITY_OR_OTHER|||||||0.164||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1640
73909328|NCT00866788|147348399|SUPERIORITY_OR_OTHER|||||||0.0005||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0005
73909329|NCT00866788|147348399|SUPERIORITY_OR_OTHER|||||||0.0558||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0558
74026365|NCT00095303|147605882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68||||0.12|TWO_SIDED|95.0|-0.18|1.54|||GEE|||||1.54|-.18|.12
74026366|NCT00095303|147605883|SUPERIORITY_OR_OTHER||Slope|0.33||||0.12|TWO_SIDED|95.0|-0.09|0.76|||GEE||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: BSFT will be significantly more effective than TAU in decreasing sexually risky behaviors. The total score of the 'HIV/Sex Risk Behaviors' measure will be used as the outcome.Hypothesis analyzed using the hierarchical linear model.||.76|-.09|.12
74026367|NCT00095303|147605887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.23|TWO_SIDED|95.0|-0.09|0.37|||GEE|||||.37|-.09|.23
74026368|NCT01364467|147605888|OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
73909330|NCT00866788|147348400|SUPERIORITY_OR_OTHER|||||||0.1411||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1411
73909331|NCT00866788|147348400|SUPERIORITY_OR_OTHER|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0003
73909332|NCT00866788|147348400|SUPERIORITY_OR_OTHER|||||||0.0248||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0248
73909333|NCT00866788|147348401|SUPERIORITY_OR_OTHER|||||||0.5507||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.5507
73909334|NCT00866788|147348401|SUPERIORITY_OR_OTHER|||||||0.1525||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1525
73909335|NCT00866788|147348401|SUPERIORITY_OR_OTHER|||||||0.0449||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0449
73909336|NCT00866788|147348402|SUPERIORITY_OR_OTHER|||||||0.7261||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.7261
73909337|NCT00866788|147348402|SUPERIORITY_OR_OTHER|||||||0.162||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.162
73909338|NCT00866788|147348402|SUPERIORITY_OR_OTHER|||||||0.6504||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.6504
74026369|NCT01364467|147605889|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||0.98
74026370|NCT01364467|147605889|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.65
74026371|NCT03842137|147605910|SUPERIORITY||Slope|-0.53|STANDARD_ERROR_OF_MEAN|0.19||0.008|TWO_SIDED|95.0|-0.91|-0.15|||Regression, Linear|Utilizing a regression model, baseline craving scores, group condition, and their interaction are regressed on 2-week craving scores.||||-.15|-.91|.008
74085267|NCT03180801|147724266|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.||||0.128
73909339|NCT02742441|147348409|SUPERIORITY||||||<|0.001||||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||||||<0.001
73909340|NCT02742441|147348410|SUPERIORITY||||||<|0.001||||||Statistical significance was achieved for each of the clinical signs of psoriasis.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (plaque elevation, scaling, and erythema).||||<0.001
73909341|NCT02742441|147348411|SUPERIORITY|||||||0.012|||||||Cochran-Mantel-Haenszel|||||||0.012
73909342|NCT02281773|147348437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1256|TWO_SIDED|95.0|-2.76|0.34||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||0.34|-2.76|0.1256
73909343|NCT02281773|147348437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.8||0.7337|TWO_SIDED|95.0|-1.3|1.84||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||1.84|-1.30|0.7337
73909344|NCT02281773|147348437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.83||0.6994|TWO_SIDED|95.0|-1.31|1.95||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||1.95|-1.31|0.6994
73909345|NCT02281773|147348437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.79||0.427|TWO_SIDED|95.0|-2.19|0.93||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||0.93|-2.19|0.4270
73909346|NCT02281773|147348442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.66||0.5972|TWO_SIDED|95.0|-0.9|1.6||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.6|-0.9|0.5972
73909347|NCT02281773|147348442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3817|TWO_SIDED|95.0|-1.9|0.7||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.7|-1.9|0.3817
73909348|NCT02281773|147348442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.68||0.48|TWO_SIDED|95.0|-0.9|1.8||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.8|-0.9|0.4800
73930955|NCT00280566|147391712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.27||0.2394|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2394
74085268|NCT03180801|147724266|OTHER|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.||||0.601
73909349|NCT02281773|147348442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.7507|TWO_SIDED|95.0|-1.1|1.5||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.5|-1.1|0.7507
73909350|NCT02281773|147348443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9399|TWO_SIDED|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.1|-0.1|0.9399
73964724|NCT03398148|147465174|SUPERIORITY||Adjusted Risk Difference|8.3||||0.0192|TWO_SIDED|90.0|2.5|14.1||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||14.1|2.5|0.0192
73964725|NCT03398148|147465174|SUPERIORITY||Adjusted Risk Difference|4.8||||0.0706|TWO_SIDED|90.0|0.4|9.1||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||9.1|0.4|0.0706
73964726|NCT03398148|147465174|SUPERIORITY||Adjusted Risk Difference|8.7||||0.017|TWO_SIDED|90.0|2.7|14.6||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||14.6|2.7|0.0170
73964727|NCT03398148|147465175|SUPERIORITY|||||||0.7737|||||||Chi-squared|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7737
73964728|NCT03398148|147465175|SUPERIORITY|||||||0.7432|||||||Fisher Exact|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7432
73964729|NCT03398148|147465175|SUPERIORITY|||||||0.7172|||||||Fisher Exact|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7172
73964730|NCT03398148|147465176|SUPERIORITY||Adjusted Risk Difference|4.7||||0.0722|TWO_SIDED|90.0|0.4|9.0||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||9.0|0.4|0.0722
73964731|NCT03398148|147465176|SUPERIORITY||Adjusted Risk Difference|3.1||||0.148|TWO_SIDED|90.0|-0.4|6.6|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||6.6|-0.4|0.1480
73964732|NCT03398148|147465176|SUPERIORITY||Adjusted Risk Difference|1.7||||0.3042|TWO_SIDED|90.0|-1.0|4.5|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||4.5|-1.0|0.3042
73964733|NCT03398148|147465177|SUPERIORITY||Least Squares (LS) Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|2.13||0.003|TWO_SIDED|90.0|-9.94|-2.89||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||-2.89|-9.94|0.0030
73964734|NCT03398148|147465177|SUPERIORITY||Least Squares (LS) Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|2.11||0.0001|TWO_SIDED|90.0|-11.67|-4.71||P-value ≤ 0.001|Mixed-effect model repeated measurement|||||-4.71|-11.67|0.0001
73964735|NCT03398148|147465177|SUPERIORITY||Least Squares (LS) Mean Difference|-7.7|STANDARD_ERROR_OF_MEAN|2.14||0.0004|TWO_SIDED|90.0|-11.27|-4.19||P-value ≤ 0.001|Mixed-effect model repeated measurement|||||-4.19|-11.27|0.0004
73964736|NCT03398148|147465178|SUPERIORITY||Least Squares (LS) Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|6.47||0.0081|TWO_SIDED|90.0|6.61|28.0||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||28|6.61|0.0081
73964737|NCT03398148|147465178|SUPERIORITY||Least Squares (LS) Mean Difference|20.3|STANDARD_ERROR_OF_MEAN|6.37||0.0017|TWO_SIDED|90.0|9.74|30.79||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||30.79|9.74|0.0017
73964738|NCT03398148|147465178|SUPERIORITY||Least Squares (LS) Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|6.49||0.0024|TWO_SIDED|90.0|9.22|30.67||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||30.67|9.22|0.0024
73964739|NCT03398148|147465179|SUPERIORITY||Least Squares (LS) Mean Difference|1.208||||0.3315|TWO_SIDED|90.0|-0.8429|3.2596|||Mixed-effect model repeated measurement|||||3.2596|-0.8429|0.3315
73964740|NCT03398148|147465179|SUPERIORITY||LS Mean of Difference|2.447||||0.0451|TWO_SIDED|90.0|0.4415|4.4519||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||4.4519|0.4415|0.0451
73964741|NCT03398148|147465179|SUPERIORITY||LS Mean of Difference|2.392||||0.0543|TWO_SIDED|90.0|0.3498|4.4352||P-value ≤ 0.1|Mixed-effect model repeated measurement|||||4.4352|0.3498|0.0543
73964742|NCT03398148|147465180|SUPERIORITY||LS Mean of Difference|3.662||||0.0367|TWO_SIDED|90.0|0.7841|6.5402||P-value \<= 0.1|Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||6.5402|0.7841|0.0367
73964743|NCT03398148|147465180|SUPERIORITY||LS Mean of Difference|4.19||||0.0151|TWO_SIDED|90.0|1.3656|7.0144||P-value \<= 0.05|Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||7.0144|1.3656|0.0151
74026372|NCT03842137|147605911|SUPERIORITY|An ancova model was conducted comparing differences between tDCS and sham on post-stimulation theta burst rate, while controlling for pre-stimulation theta burst rate||||||0.005|||||||ANCOVA|||||||.005
74026373|NCT00780403|147605925|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Statistical tests were performed at the significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.||||<0.0001
73909351|NCT02281773|147348443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9919|TWO_SIDED|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.1|-0.1|0.9919
73909352|NCT02281773|147348443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.3027|TWO_SIDED|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.2|-0.1|0.3027
73909353|NCT02281773|147348443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.3901|TWO_SIDED|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.2|-0.1|0.3901
73909354|NCT00313300|147348487|SUPERIORITY_OR_OTHER||Adjusted rate difference|2.2|||||TWO_SIDED|95.0|-1.0|5.4|||||adjusted difference of event rates takes into consideration stratification factors.|||5.4|-1.0|
73909355|NCT00313300|147348487|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|3.8|||||TWO_SIDED|95.0|0.4|7.3|||||adjusted difference of event rates takes into consideration stratification factors.|||7.3|0.4|
73909356|NCT00313300|147348488|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.44|1.19||||||||1.19|0.44|
73909357|NCT00313300|147348488|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.35|1.04||||||||1.04|0.35|
73909358|NCT00313300|147348489|SUPERIORITY_OR_OTHER||Adjusted rate difference|6.6|||||TWO_SIDED|95.0|1.8|11.3|||||adjusted difference of event rates takes into consideration stratification factors.|||11.3|1.8|
73909359|NCT00313300|147348489|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.0|||||TWO_SIDED|95.0|4.8|15.2|||||adjusted difference of event rates takes into consideration stratification factors.|||15.2|4.8|
73909360|NCT00313300|147348490|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.44|1.17||||||||1.17|0.44|
73909361|NCT00313300|147348490|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.37|1.07||||||||1.07|0.37|
73909362|NCT00313300|147348491|SUPERIORITY_OR_OTHER||Adjusted rate difference|0.3|||||TWO_SIDED|95.0|-1.3|2.0|||||adjusted difference of event rates takes into consideration stratification factors.|||2.0|-1.3|
73909363|NCT00313300|147348491|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|0.8|||||TWO_SIDED|95.0|-1.1|2.7|||||adjusted difference of event rates takes into consideration stratification factors.|||2.7|-1.1|
73909364|NCT00313300|147348492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.44|2.88||||||||2.88|0.44|
73909365|NCT00313300|147348492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.29|2.57||||||||2.57|0.29|
73909366|NCT00313300|147348492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.3|1.66||||||||1.66|0.30|
73909367|NCT00313300|147348492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.3|1.74||||||||1.74|0.30|
73909368|NCT00313300|147348493|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.0|||||TWO_SIDED|95.0|0.0|8.1||||||||8.1|0.0|
73909369|NCT00313300|147348493|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.7|||||TWO_SIDED|95.0|0.0|9.3||||||||9.3|0.0|
73909370|NCT00313300|147348493|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|7.0|||||TWO_SIDED|95.0|3.4|10.5||||||||10.5|3.4|
73909371|NCT00313300|147348493|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.7|||||TWO_SIDED|95.0|1.4|8.0||||||||8.0|1.4|
73909372|NCT00313300|147348494|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|8.3|||||TWO_SIDED|95.0|1.8|14.9||||||||14.9|1.8|
73909373|NCT00313300|147348494|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.9|||||TWO_SIDED|95.0|3.4|18.4||||||||18.4|3.4|
73909374|NCT00313300|147348494|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|17.4|||||TWO_SIDED|95.0|11.6|23.2||||||||23.2|11.6|
73909375|NCT00313300|147348494|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.4|||||TWO_SIDED|95.0|5.6|15.1||||||||15.1|5.6|
73909376|NCT00313300|147348495|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.44|2.88||||||||2.88|0.44|
73909377|NCT00313300|147348495|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.29|2.57||||||||2.57|0.29|
73909378|NCT00313300|147348495|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.71|||||TWO_SIDED|95.0|0.3|1.66||||||||1.66|0.30|
73909379|NCT00313300|147348495|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72|||||TWO_SIDED|95.0|0.3|1.74||||||||1.74|0.30|
73909380|NCT00313300|147348496|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|0.8|||||TWO_SIDED|95.0|-0.9|2.6||||||||2.6|-0.9|
74026374|NCT04322708|147605926|SUPERIORITY||Percent Difference from Placebo|81.6|||<|0.0001|TWO_SIDED|95.0|71.5|89.0|||Fisher Exact|||||89.0|71.5|<0.0001
74085269|NCT03180801|147724267|OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.||||0.142
74026375|NCT04322708|147605926|SUPERIORITY||Percent Difference from Placebo|77.0|||<|0.0001|TWO_SIDED|95.0|66.1|85.4|||Fisher Exact|||||85.4|66.1|<0.0001
74026376|NCT04322708|147605927|SUPERIORITY||LSM Difference from Placebo|2.7||||0.247|TWO_SIDED|95.0|-1.9|7.3|||ANCOVA|||||7.3|-1.9|0.2470
74085270|NCT03180801|147724267|OTHER|||||||0.147|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.||||0.147
74085271|NCT03180801|147724268|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.||||0.080
74085272|NCT03180801|147724268|OTHER|||||||0.271|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.||||0.271
73909381|NCT00313300|147348496|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|2.9|||||TWO_SIDED|95.0|0.6|5.1||||||||5.1|0.6|
73909382|NCT00313300|147348496|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.1|||||TWO_SIDED|95.0|1.3|6.9||||||||6.9|1.3|
73909383|NCT00398918|147348536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|3.4|<|0.05||95.0|||||Mixed Models Analysis|Results presented are for post-hoc comparisons of least squares means with Tukey-Kramer adjucted p values.|The estimated value is for the difference between the means obtained for the second hour of the self-administration sessions for the placebo and zonisamide conditions.|The analysis involved a within subjects comparison. The null hypothesis was that there would be no difference in the amount of ethanol consumed in either the first or second hour of self-administration sessions. Results presented here are for the second hour of the self-administration sessions.||||<0.05
73909384|NCT00398918|147348537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|5.7||0.61||95.0||||P value shown is for a post-hoc comparison of least squares means generated by the mixed model used.|Mixed Models Analysis||Analysis for difference between DSMT scores at 40 minutes post alcohol ingestion for zonisamide and placebo involved post-hoc comparisons of least squares means.|Null hypothesis: No difference in DSMT scores for zonisamide and placebo treatments 40 minutes after ingestion of ethanol.||||0.61
73909385|NCT01788046|147348538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|30.8|||<|0.001|TWO_SIDED|95.0|18.18|52.17|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (\< 600, ≥ 600 to ≤ 1000, and \> 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of percentage of participants with \> 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.||52.17|18.18|< 0.001
73909386|NCT01788046|147348539|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|33.92|||<|0.001|TWO_SIDED|95.0|16.35|70.37|||Cochran-Mantel-Haenszel|Stratified by screening PTH category, prior cinacalcet use within 8 weeks prior to randomization, and region.||||70.37|16.35|< 0.001
73909387|NCT01788046|147348540|SUPERIORITY_OR_OTHER||Mean Difference|-71.34|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-77.53|-65.14|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-65.14|-77.53|< 0.001
73909388|NCT01788046|147348541|SUPERIORITY_OR_OTHER||Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-8.38|-6.03|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-6.03|-8.38|< 0.001
73909389|NCT01788046|147348542|SUPERIORITY_OR_OTHER||Mean Difference|-14.58|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-18.65|-10.51|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-10.51|-18.65|< 0.001
73909390|NCT01788046|147348543|SUPERIORITY_OR_OTHER||Mean Difference|-8.04|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-12.15|-3.92|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-3.92|-12.15|< 0.001
73909391|NCT01856907|147348544|SUPERIORITY|||||||0.035|||||||McNemar|||Study change from dysglycemia to normal glucose state||||.035
73909392|NCT01856907|147348545|SUPERIORITY|||||||0.044|||||||ANOVA|||Subjects (SS)/ Treatment Group x repeated measures (visit) design||||0.044
74026377|NCT04322708|147605927|SUPERIORITY||LSM Difference from Placebo|-2.8||||0.2372|TWO_SIDED|95.0|-7.3|1.8|||ANCOVA|||||1.8|-7.3|0.2372
74026378|NCT04322708|147605928|SUPERIORITY||LSM Difference from Placebo|-95.7|||<|0.0001|TWO_SIDED|95.0|-109.0|-82.4|||ANCOVA|||||-82.4|-109|<0.0001
74026379|NCT04322708|147605928|SUPERIORITY||LSM Difference from Placebo|-96.2|||<|0.0001|TWO_SIDED|95.0|-110.0|-82.5|||ANCOVA|||||-82.5|-110|<0.0001
74026380|NCT04322708|147605929|SUPERIORITY||Percent Difference from Placebo|83.8|||<|0.0001|TWO_SIDED|95.0|74.4|90.8|||Fisher Exact|||||90.8|74.4|<0.0001
74085273|NCT03180801|147724269|OTHER|||||||0.099|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.||||0.099
74085274|NCT03180801|147724269|OTHER|||||||0.178|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.||||0.178
74085275|NCT03180801|147724270|OTHER|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.||||0.064
74085276|NCT03180801|147724270|OTHER|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.||||0.201
74085277|NCT03180801|147724271|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison on day -2||||<0.001
74085278|NCT03180801|147724271|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparion on day -2||||<0.001
74085279|NCT03180801|147724271|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 35||||<0.001
74085280|NCT03180801|147724271|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 35||||<0.001
74085281|NCT03180801|147724271|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 63||||<0.001
74085282|NCT03180801|147724271|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 63||||<0.001
73964744|NCT03398148|147465180|SUPERIORITY||LS Mean of Difference|2.348||||0.1795|TWO_SIDED|90.0|-0.5322|5.2281|||Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||5.2281|-0.5322|0.1795
73964745|NCT03398148|147465181|SUPERIORITY||Least Squares (LS) Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.91||0.0422|TWO_SIDED|90.0|0.75|7.06||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||7.06|0.75|0.0422
73964746|NCT03398148|147465181|SUPERIORITY||Least Squares (LS) Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.87||0.0049|TWO_SIDED|90.0|2.23|8.42||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||8.42|2.23|0.0049
73964747|NCT03398148|147465181|SUPERIORITY||Least Squares (LS) Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.91||0.0156|TWO_SIDED|90.0|1.5|7.8||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||7.80|1.50|0.0156
73964748|NCT03398148|147465182|SUPERIORITY|||||||1||||||P-Value for comparisons between treatment groups and placebo group using Fisher's exact test.|Fisher Exact|||Note: ITT1A includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 1.||||1
73964749|NCT03398148|147465183|SUPERIORITY||Adjusted Risk Difference|28.6|||<|0.0001|TWO_SIDED|95.0|22.3|34.8||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.|||34.8|22.3|<0.0001
73964750|NCT03398148|147465184|SUPERIORITY||Adjusted Risk Difference|24.3|||<|0.0001|TWO_SIDED|95.0|19.3|29.4||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||29.4|19.3|<0.0001
73964751|NCT03398148|147465185|SUPERIORITY||Adjusted Risk Difference|16.6|||<|0.0001|TWO_SIDED|95.0|12.3|21.0||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||21.0|12.3|<0.0001
73964752|NCT03398148|147465186|SUPERIORITY||Adjusted Risk Difference|7.2|||<|0.0001|TWO_SIDED|95.0|4.2|10.2||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||10.2|4.2|<0.0001
73964753|NCT03398148|147465187|SUPERIORITY||Adjusted Risk Difference|21.8|||<|0.0001|TWO_SIDED|95.0|15.6|28.1||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||28.1|15.6|<0.0001
73964754|NCT03398148|147465188|SUPERIORITY||Adjusted Risk Difference|16.3|||<|0.0001|TWO_SIDED|95.0|10.3|22.4||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||22.4|10.3|<0.0001
73964755|NCT03398148|147465189|SUPERIORITY||Adjusted Risk Difference|9.3||||0.0021|TWO_SIDED|95.0|3.4|15.3||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||15.3|3.4|0.0021
73964756|NCT03398148|147465190|SUPERIORITY||Adjusted Risk Difference|5.6|||<|0.0001|TWO_SIDED|95.0|3.5|7.7||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||7.7|3.5|<0.0001
73964757|NCT03398148|147465191|SUPERIORITY||Least Squares (LS) Mean Difference|4.5|||<|0.0001|TWO_SIDED|95.0|3.13|5.97||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|ANCOVA||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||5.97|3.13|<0.0001
73964758|NCT03398148|147465192|SUPERIORITY||Least Squares (LS) Mean Difference|18.3|||<|0.0001|TWO_SIDED|95.0|13.38|23.25||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|ANCOVA||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||23.25|13.38|<0.0001
73909393|NCT01856907|147348546|SUPERIORITY|||||||0.034|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.034
73909394|NCT01856907|147348547|SUPERIORITY|||||||0.047|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||.047
73909395|NCT01856907|147348548|SUPERIORITY|||||||0.017|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.017
73909396|NCT01856907|147348549|SUPERIORITY|||||||0.014|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.014
73909397|NCT01856907|147348550|SUPERIORITY|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.042
73909398|NCT01856907|147348551|SUPERIORITY|||||||0.002|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.002
73964759|NCT03398148|147465193|SUPERIORITY||Risk Difference (RD)|-4.8|||<|0.0001|TWO_SIDED|95.0|-7.3|-2.2||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Chi-squared||95% CI for treatment differences is based on normal approximation of the binomial proportions.|||-2.2|-7.3|<0.0001
73964760|NCT03398148|147465194|SUPERIORITY||Adjusted Risk Difference|24.2|||<|0.0001|TWO_SIDED|95.0|17.9|30.5||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||30.5|17.9|<0.0001
74026381|NCT04322708|147605929|SUPERIORITY||Percent Difference from Placebo|80.3|||<|0.0001|TWO_SIDED|95.0|69.8|87.9|||Fisher Exact|||||87.9|69.8|<0.0001
74026382|NCT04322708|147605930|SUPERIORITY||Percent Difference from Placebo|77.3|||<|0.0001|TWO_SIDED|95.0|66.4|85.5|||Fisher Exact|||||85.5|66.4|<0.0001
73964761|NCT03398148|147465195|SUPERIORITY||Adjusted Risk Difference|18.6|||<|0.0001|TWO_SIDED|95.0|12.4|24.8||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.|||24.8|12.4|<0.0001
74026383|NCT04322708|147605930|SUPERIORITY||Percent Difference from Placebo|72.7|||<|0.0001|TWO_SIDED|95.0|61.3|81.9|||Fisher Exact|||||81.9|61.3|<0.0001
74026384|NCT04322708|147605931|SUPERIORITY||Percent Difference from Placebo|36.5|||<|0.0001|TWO_SIDED|95.0|22.9|49.5|||Fisher Exact|||||49.5|22.9|<0.0001
74088491|NCT01272921|147730370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-17.0|-6.0||Post hoc comparison were made against the 30-mL volume group and corrected for 6 comparisons using the Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-6.00|-17.00|0.05
73909399|NCT01856907|147348552|SUPERIORITY|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.004
73909400|NCT01856907|147348553|SUPERIORITY|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.004
73909401|NCT01856907|147348554|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
73909402|NCT00850070|147348566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.35|||||||Chi-squared||Estimated value comparison was active treatment minus placebo.|Chi-square analyses were used to assess CGI-I scores. There were no transformations.||||<.35
73909403|NCT00850070|147348567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.06|||||||Chi-squared|||||||<0.06
73909404|NCT00850070|147348573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.05|||||||Mixed Models Analysis|||||||0.05
73909405|NCT05047770|147348576|NON_INFERIORITY|The non-inferiority was to be concluded if the upper limit (UL) of the 95% confidence interval (CI) of the adjusted GMC ratio between HZ/suSeq group and HZ/suCoAd group for anti-gE antibody concentration was below (\<) 1.5.|GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.13|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 2 doses of HZ/su vaccine when the first dose of HZ/su vaccine was co-administered with the mRNA-1273 booster dose compared to HZ/su vaccine administered alone, in terms of anti-gE GMCs, at 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group).||1.13|0.89|
73909406|NCT05047770|147348577|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMC ratio between HZ/suSeq group and HZ/suCoAd group for anti-S protein antibody concentration was \<1.5.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.9|1.32|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of mRNA-1273 booster when the first dose of HZ/su vaccine was co-administered with the mRNA-1273 booster dose compared to mRNA-1273 booster dose administered alone, in terms of anti-S protein GMCs, at 1 month post-mRNA-1273 booster dose administration (at Week 4 for both HZ/suSeq and HZ/suCoAd groups).||1.32|0.90|
73909407|NCT05047770|147348578|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the A/H1N1 influenza strain.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.18|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the A/H1N1 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.18|0.89|
74026385|NCT04322708|147605931|SUPERIORITY||Percent Difference from Placebo|49.5|||<|0.0001|TWO_SIDED|95.0|35.9|61.0|||Fisher Exact|||||61.0|35.9|<0.0001
74026386|NCT04322708|147605932|SUPERIORITY||Percent Difference from Placebo|-4.8||||0.5561|TWO_SIDED|95.0|-19.2|10.0|||Fisher Exact|||||10.0|-19.2|0.5561
74026387|NCT04322708|147605932|SUPERIORITY||Percent Difference from Placebo|4.9||||0.5554|TWO_SIDED|95.0|-9.9|19.6|||Fisher Exact|||||19.6|-9.9|0.5554
74026388|NCT04322708|147605933|SUPERIORITY||LSM Difference from Placebo|-0.6||||0.9506|TWO_SIDED|95.0|-18.1|17.0|||ANCOVA|||||17.0|-18.1|0.9506
74026389|NCT04322708|147605933|SUPERIORITY||LSM Difference from Placebo|-17.6||||0.0511|TWO_SIDED|95.0|-35.4|0.1|||ANCOVA|||||0.1|-35.4|0.0511
73909408|NCT05047770|147348578|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the A/H3N2 influenza strain.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.82|1.05|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the A/H3N2 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.05|0.82|
73909409|NCT05047770|147348578|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the B/Victoria lineage influenza strain.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.89|1.14|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the B/Victoria lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.14|0.89|
73930956|NCT00280566|147391713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.29||0.8117|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8117
74026390|NCT04322708|147605934|SUPERIORITY||LSM Difference from Placebo|2.6||||0.2007|TWO_SIDED|95.0|-1.4|6.7|||Mixed Models Analysis|||Weeks 23-24 Change from Baseline||6.7|-1.4|0.2007
74026391|NCT04322708|147605934|SUPERIORITY||LSM Difference from Placebo|-2.7||||0.1889|TWO_SIDED|95.0|-6.8|1.3|||Mixed Models Analysis|||Weeks 23-24 Change from Baseline||1.3|-6.8|0.1889
74026392|NCT04322708|147605935|SUPERIORITY||LSM Difference from Placebo|-0.3||||0.498|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|||||0.6|-1.3|0.4980
74026393|NCT04322708|147605935|SUPERIORITY||LSM Difference from Placebo|0.2||||0.639|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||||1.2|-0.7|0.6390
74026394|NCT03240081|147605964|NON_INFERIORITY|We set 2 points (20%) as the margin of difference when defining and evaluating non-inferiority in comparing the 2 arms at 4 weeks.|Median Difference (Final Values)|2.0||||0.08|TWO_SIDED|||||Threshold for significance \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.08
74026395|NCT03240081|147605965|NON_INFERIORITY|We set 2 points (20%) as the margin of difference when evaluating non-inferiority in comparing the 2 arms at 4 weeks.|Median Difference (Final Values)|2.0||||0.95|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.95
74026396|NCT01480180|147606003|OTHER||Poisson estimate|3.7|||<|0.001|TWO_SIDED|95.0|2.94|4.66||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||4.66|2.94|<0.001
74026397|NCT01480180|147606005|OTHER||Poisson estimate|3.27|||<|0.001|TWO_SIDED|95.0|2.59|4.11||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||4.11|2.59|<0.001
74026398|NCT01480180|147606007|OTHER||Poisson estimate|2.35|||<|0.001|TWO_SIDED|95.0|1.87|2.95||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||2.95|1.87|<0.001
74026399|NCT01480180|147606007|OTHER||Poisson estimate|4.39|||<|0.001|TWO_SIDED|95.0|3.09|6.24||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||6.24|3.09|<0.001
74026400|NCT03429075|147606081|EQUIVALENCE|ANCOVA||||||0.17|||||||ANCOVA|||||||0.17
74026401|NCT01650805|147606093|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||0.074
73930957|NCT00280566|147391713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.26||0.0443|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0443
73930958|NCT00280566|147391713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.28||0.3039|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3039
73930959|NCT00280566|147391713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.46||0.9953|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9953
73930960|NCT00280566|147391713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.32||0.1653|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1653
73909410|NCT05047770|147348578|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the B/Yamagata lineage influenza strain.|GMT Ratio|1.04|||||TWO_SIDED|95.0|0.93|1.17|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the B/Yamagata lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.17|0.93|
73909411|NCT05047770|147348579|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMC ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-S antibody concentration was \<1.5.|GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.13|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of mRNA-1273 booster when co-administered with Flu D-QIV vaccine compared to mRNA-1273 booster dose administered alone in terms of anti-S protein GMCs, at 1 month post-mRNA-1273 booster dose administration (at Week 4 for both FluD-QIVSeq and FluD-QIVCoAd groups).||1.13|0.84|
73909412|NCT05047770|147348580|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the A/H1N1 influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|0.6|||||TWO_SIDED|95.0|-5.1|6.4|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the A/H1N1 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||6.4|-5.1|
73909413|NCT05047770|147348580|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the A/H3N2 influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|-1.3|||||TWO_SIDED|95.0|-7.8|5.2|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the A/H3N2 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||5.2|-7.8|
74026402|NCT01650805|147606095|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||<0.001
73909414|NCT05047770|147348580|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the B/Victoria lineage influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|0.1|||||TWO_SIDED|95.0|-5.8|5.9|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the B/Victoria lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||5.9|-5.8|
73964762|NCT03398148|147465196|SUPERIORITY||Least Squares (LS) Mean Difference|-1.627|||<|0.0001|TWO_SIDED|95.0|-2.3846|-0.8689||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Mixed-Effect Model Repeated Measures||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||-0.8689|-2.3846|<0.0001
73964763|NCT03398148|147465197|SUPERIORITY||Least Squares (LS) Mean Difference|-0.981|||<|0.0001|TWO_SIDED|95.0|-1.3285|-0.6326||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Mixed-Effect Model Repeated Measures||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||-0.6326|-1.3285|<0.0001
73964764|NCT02791230|147465204|SUPERIORITY||Hazard Ratio (HR)|0.6202||||0.0001|TWO_SIDED|95.0|0.4865|0.7906|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, Transthyretin (TTR) genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.7906|0.4865|0.0001
73964765|NCT02791230|147465207|SUPERIORITY||Hazard ratio|0.6133||||0.0005|TWO_SIDED|95.0|0.4666|0.8062|||Cox Proportional Hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.8062|0.4666|0.0005
73964766|NCT04201834|147465236|SUPERIORITY|||||||0.27|||||||Paired T-Test|||||||0.27
73964767|NCT04201834|147465237|SUPERIORITY|||||||0.92|||||||Paired T-Test|||||||0.92
73964768|NCT04201834|147465238|SUPERIORITY|||||||0.36|||||||Paired T-Test|||||||0.36
73964769|NCT04201834|147465239|SUPERIORITY|||||||0.62|||||||Paired T-Test|||||||0.62
73964770|NCT04201834|147465242|SUPERIORITY|||||||0.11|||||||Paired T-Test|||||||0.11
73964771|NCT04201834|147465243|SUPERIORITY|||||||0.02|||||||Paired T-Test|||||||0.02
73964772|NCT04201834|147465245|SUPERIORITY|||||||0.86|||||||Paired T-Test|||||||0.86
73964773|NCT04201834|147465246|SUPERIORITY|||||||0.27|||||||Paired T-Test|||||||0.27
73964774|NCT04201834|147465247|SUPERIORITY|||||||0.61|||||||Paired T-Test|||||||0.61
73964775|NCT04201834|147465248|SUPERIORITY|||||||0.37|||||||Paired T-Test|||||||0.37
73964776|NCT04201834|147465249|SUPERIORITY|||||||0.3|||||||Paired T-Test|||||||0.30
73964777|NCT04201834|147465250|SUPERIORITY|||||||0.82|||||||Paired t-test|||||||0.82
73964778|NCT05540535|147465253|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|The Wilcoxon signed-rank test was used for a within-group comparison.||||||<0.05
73964779|NCT05540535|147465254|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73909415|NCT05047770|147348580|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the B/Yamagata influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|-1.6|||||TWO_SIDED|95.0|-7.0|3.9|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the B/Yamagata influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||3.9|-7.0|
73909416|NCT03569033|147348624|OTHER||Difference in Least Squares Means|-0.32||||0.748|TWO_SIDED|95.0|-2.29|1.66|||Longitudinal Data Analysis|||||1.66|-2.29|0.748
73909417|NCT03569033|147348625|OTHER||Difference in Least Squares Means|0.99||||0.754|TWO_SIDED|95.0|-5.33|7.3|||ANCOVA|||||7.30|-5.33|0.754
73909418|NCT03569033|147348626|OTHER||Difference in Least Squares Means|0.8||||0.627|TWO_SIDED|95.0|-2.5|4.1|||ANCOVA|||||4.10|-2.50|0.627
73909419|NCT03569033|147348627|OTHER||Difference in Least Squares Means|0.09||||0.631|TWO_SIDED|95.0|-0.28|0.45|||ANCOVA|||||0.45|-0.28|0.631
73964780|NCT05540535|147465255|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|The Wilcoxon signed-rank test was used for a within-group comparison.||||||<0.05
73909420|NCT00395733|147348635|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for investigators only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9736||||||90.0|0.9315|1.0168|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||1.0168|0.9315|
73909421|NCT00395733|147348635|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 1 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.954||||||90.0|0.9122|0.9965|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||0.9965|0.9122|
73964781|NCT05540535|147465256|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73964782|NCT05540535|147465257|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
73964783|NCT05540535|147465258|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
73964784|NCT05540535|147465259|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
73964785|NCT03089125|147465260|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.038|TWO_SIDED|95.0|-0.61|-0.05||Bonferroni-adjusted P-value|ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||-0.05|-0.61|0.038
74026403|NCT01650805|147606096|SUPERIORITY_OR_OTHER|||||||0.317|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||0.317
74026404|NCT00770861|147606112|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Between-treatment comparison of efficacy was performed by ANCOVA, with treatment, baseline BMI, center as factors \& baseline value as a covariate.||H0 - There was no difference in BP reduction between Neb and Placebo. The efficacy analyses were based on the ITT population for the double-blind treatment phase. The LOCF was used to impute missing postbaseline values. Sensitivity analyses were based on observed cases for all efficacy parameters. All statistical tests were two-sided hypothesis tests performed at the 5% level of significance for main effects. All confidence intervals were two-sided 95% confidence intervals.||||<0.0001
74026405|NCT00770861|147606113|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
73964786|NCT03089125|147465261|SUPERIORITY||Mean Difference (Final Values)|-0.55|||>|0.99|TWO_SIDED|95.0|-2.2|1.1||Bonferroni-adjusted P-value|ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||1.10|-2.20|>0.99
73964787|NCT03089125|147465262|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.38|TWO_SIDED|95.0|-1.98|5.18|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||5.18|-1.98|0.380
73964788|NCT03089125|147465263|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.99|TWO_SIDED|95.0|-0.83|0.82|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||0.82|-0.83|0.990
73964789|NCT03089125|147465264|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.251|TWO_SIDED|95.0|-1.34|0.35|||ANCOVA|||||0.35|-1.34|0.251
73964790|NCT03089125|147465265|SUPERIORITY||Mean Difference (Final Values)|-1.49||||0.647|TWO_SIDED|95.0|-7.9|4.92|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||4.92|-7.90|0.647
73964791|NCT03089125|147465266|SUPERIORITY||Mean Difference (Final Values)|1.63||||0.431|TWO_SIDED|95.0|-2.45|5.71||ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.|ANCOVA|||||5.71|-2.45|0.431
73964792|NCT03089125|147465267|SUPERIORITY||Between-group diff in change per 8 weeks|-0.06||||0.71|TWO_SIDED|95.0|-0.38|0.26|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||0.26|-0.38|0.710
73909422|NCT00395733|147348635|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 2 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9458||||||90.0|0.8776|1.024|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||1.0240|0.8776|
73909423|NCT00395733|147348635|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 3 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.8698||||||90.0|0.78|0.9657|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||0.9657|0.7800|
73909424|NCT03725852|147348644|SUPERIORITY||Least square (LS) mean difference|42.33|STANDARD_ERROR_OF_MEAN|61.483||0.495|TWO_SIDED|95.0|-81.84|166.49||P-value was based on an analysis of covariance (ANCOVA) model at each time point including treatment, sex, stratum (nintedanib, pirfenidone or neither), age, height, and baseline value as covariates.|ANCOVA|||Change at Week 26||166.49|-81.84|0.495
73909425|NCT03725852|147348645|SUPERIORITY||Difference in Percentage|1.7|||||TWO_SIDED|95.0|-17.3|24.5|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs||24.5|-17.3|
73909426|NCT03725852|147348645|SUPERIORITY||Difference in Percentage|15.7|||||TWO_SIDED|95.0|-3.0|30.7|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|Serious TEAEs||30.7|-3.0|
73909427|NCT03725852|147348645|SUPERIORITY||Difference in Percentage|31.4|||||TWO_SIDED|95.0|8.2|49.4|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs related to study drug||49.4|8.2|
73909428|NCT03725852|147348645|SUPERIORITY||Difference in Percentage|22.2|||||TWO_SIDED|95.0|6.7|36.4|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs leading to study drug discontinuation||36.4|6.7|
73909429|NCT03725852|147348646|SUPERIORITY|||||||0.397|||||||Log Rank|||All-cause deaths||||0.397
73909430|NCT03725852|147348646|SUPERIORITY|||||||0.397|||||||Log Rank|||Respiratory-related deaths||||0.397
73909431|NCT03725852|147348646|SUPERIORITY|||||||0.131|||||||Log Rank|||All-cause hospitalizations||||0.131
73909432|NCT03725852|147348646|SUPERIORITY|||||||0.762|||||||Log Rank|||Respiratory-related hospitalizations||||0.762
73909433|NCT03725852|147348647|SUPERIORITY||Weighted LS mean difference|-9.11|STANDARD_ERROR_OF_MEAN|15.713||0.565|TWO_SIDED|95.0|-40.87|22.64||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline 6MWT distance as covariates.|ANCOVA|||Change at Week 26||22.64|-40.87|0.565
73909434|NCT03725852|147348648|SUPERIORITY||Weighted LS mean difference.|-1.58|STANDARD_ERROR_OF_MEAN|3.71||0.673|TWO_SIDED|95.0|-9.06|5.91||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26||5.91|-9.06|0.673
73909435|NCT03725852|147348649|SUPERIORITY||Weighted LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|4.591||0.875|TWO_SIDED|95.0|-9.98|8.53||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Symptoms score||8.53|-9.98|0.875
73909436|NCT03725852|147348649|SUPERIORITY||Weighted LS mean difference|-4.14|STANDARD_ERROR_OF_MEAN|5.038||0.416|TWO_SIDED|95.0|-14.29|6.02||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Activity score||6.02|-14.29|0.416
73909437|NCT03725852|147348649|SUPERIORITY||Weighted LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|4.029||0.961|TWO_SIDED|95.0|-8.32|7.92||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Impacts score||7.92|-8.32|0.961
73909438|NCT03725852|147348650|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73909439|NCT03072732|147348673|NON_INFERIORITY|The µ-Cor System will be considered non-inferior with respect to clinical performance (i.e., trends in fluid change) of the ZOE device if the lower 95% confidence interval of the differences (Primary Measurement) is greater than the non-inferiority margin of -0.05.|Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|0.57|0.75|||||"Because the distribution was skewed, the average was calculated by 1) Fisher Transformation of values, 2) averaging the transformed values, 3) back calculating the mean.~The Taylor Series expansion and Delta method was used to determine variance."|"The null hypothesis was that the correlation coefficient of the ZOE device would be greater than the correlation coefficient of the uCor device by at least 0.05.~For each subject, a correlation coefficient was calculated between study arm 1 uCor readings and UFV, as well as ZOE readings and UFV.~The difference between uCor correlation coefficient and ZOE correlation coefficient for each subject was used as the Primary Measurement."||0.75|0.57|
74026406|NCT00630032|147606155|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.175|TWO_SIDED|95.0|0.59|1.1|||Log Rank|||||1.10|0.59|0.175
74026407|NCT00630032|147606156|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.1687|TWO_SIDED|95.0|0.53|1.11|||Log Rank|||||1.11|0.53|0.1687
73909440|NCT03072732|147348673|NON_INFERIORITY|The µ-Cor System will be considered non-inferior with respect to clinical performance (i.e., trends in fluid change) of the ZOE device if the lower 95% confidence interval of the differences (Primary Measurement) is greater than the non-inferiority margin of -0.05.|Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|0.12|0.35|||||"Because the distribution was skewed, the average was calculated by 1) Fisher Transformation of values, 2) averaging the transformed values, 3) back calculating the mean.~The Taylor Series expansion and Delta method was used to determine variance."|"The null hypothesis was that the correlation coefficient of the ZOE device would be greater than the correlation coefficient of the uCor device by at least 0.05.~For each subject, a correlation coefficient was calculated between study arm 2 uCor readings and UFV, as well as ZOE readings and UFV.~The difference between uCor correlation coefficient and ZOE correlation coefficient for each subject was used as the Primary Measurement."||0.35|0.12|
73909441|NCT03452228|147348674|SUPERIORITY||Median Difference (Final Values)|-43.5|||||TWO_SIDED|95.0|-89.4|1238.9||||||||1238.9|-89.4|
73909442|NCT03452228|147348674|SUPERIORITY||Median Difference (Final Values)|-75.5|||||TWO_SIDED|95.0|-82.2|121.2||||||||121.2|-82.2|
73909443|NCT00810693|147348692|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew/died before 12 weeks were imputed with worst value of 0m in case of death or clinical worsening without termination visit and with last observed value otherwise. Comparison was done using ANCOVA, with baseline 6MWD as a covariate and treatment group, region and treatment naive/add-on therapy as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant||||<0.0001
73909444|NCT00810693|147348692|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.78|||<|0.0001|TWO_SIDED|95.0|20.06|51.51||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||51.51|20.06|<0.0001
74026408|NCT00630032|147606157|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.6502|TWO_SIDED|95.0|0.45|1.63|||Log Rank|||||1.63|0.45|0.6502
74026409|NCT00630032|147606158|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0665|TWO_SIDED|95.0|0.49|1.02|||Log Rank|||||1.02|0.49|0.0665
73909445|NCT00810693|147348692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
73909446|NCT00810693|147348693|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
73909447|NCT00810693|147348693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-225.72|||<|0.0001|TWO_SIDED|95.0|-281.37|-170.08||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-170.08|-281.37|<0.0001
73909448|NCT00810693|147348693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
73909449|NCT00810693|147348694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
73909450|NCT00810693|147348694|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-431.81||||0.0157|TWO_SIDED|95.0|-781.52|-82.1||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-82.10|-781.52|0.0157
73909451|NCT00810693|147348694|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
74026410|NCT00630032|147606159|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.148|TWO_SIDED|95.0|0.59|1.08|||Log Rank|||||1.08|0.59|0.148
74026411|NCT00630032|147606160|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8968|TWO_SIDED|95.0|0.67|1.42|||Log Rank|||||1.42|0.67|0.8968
74026412|NCT03439345|147606163|SUPERIORITY|For the time-to-event analyses, survival analytic methods will be used to evaluate the time to the first event during the entire study period. Cox proportional hazards regression analyses, adjusted for baseline covariates used in minimised randomisation, will be used to estimate the hazard ratios, 95% confidence intervals and corresponding p-values, comparing all participants allocated active fenofibrate with all those allocated placebo.|Hazard Ratio (HR)|0.73||||0.006|TWO_SIDED|95.0|0.58|0.91|||Regression, Cox|Adjusted for baseline covariates used in minimised randomisation.||||0.91|0.58|0.006
74026413|NCT03439345|147606164|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.72||||0.005|TWO_SIDED|95.0|0.57|0.91|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.91|0.57|0.005
74026414|NCT03439345|147606165|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.58||||0.08|TWO_SIDED|95.0|0.31|1.06|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.06|0.31|0.08
74026415|NCT03439345|147606166|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.74||||0.003|TWO_SIDED|95.0|0.61|0.9|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.90|0.61|0.003
74026416|NCT03439345|147606167|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.66||||0.001|TWO_SIDED|95.0|0.52|0.85|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.85|0.52|0.001
74026417|NCT03439345|147606168|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.5||||0.008|TWO_SIDED|95.0|0.3|0.84|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.84|0.30|0.008
73909452|NCT00810693|147348695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0033||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.||||0.0033
73909453|NCT00810693|147348696|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.2||||0.0046|TWO_SIDED|95.0|-9.85|-0.55||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region and therapy naive/add-on therapy|Based on Mantel-Haenszel estimate stratified by region and therapy naive/add-on therapy.|"The test is for difference of occurence of Any event."||-0.55|-9.85|0.0046
73909454|NCT00810693|147348697|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0022
73909455|NCT00810693|147348698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0663||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0663
73909456|NCT00810693|147348698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.0197|TWO_SIDED|95.0|0.01|0.11||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||0.11|0.01|0.0197
73909457|NCT00810693|147348698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
73909458|NCT00810693|147348699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test. Nominally significant only due to hierarchical testing."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0019
73909459|NCT00810693|147348699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.17||||0.0009|TWO_SIDED|95.0|-9.79|-2.54||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-2.54|-9.79|0.0009
73909460|NCT00810693|147348699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
73909461|NCT02345226|147348745|NON_INFERIORITY|A sample size of 400 HIV-1 infected participants per treatment group would provide 95% power to detect a non-inferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and EFV/FTC/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-2.0|||||TWO_SIDED|95.001|-5.9|1.8|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the EFV/FTC/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the EFV/FTC/TDF group.||1.8|-5.9|
73909462|NCT02345226|147348745|SUPERIORITY|||||||0.35|||||||Fisher Exact|||||||0.35
73909463|NCT01848704|147348757|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.03|TWO_SIDED|95.0|0.07|1.35|||Mixed Models Analysis|||||1.35|0.07|0.03
73909464|NCT01848704|147348758|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.03|TWO_SIDED|95.0|-1.13|-0.05|||Mixed Models Analysis|||||-0.05|-1.13|0.03
73909465|NCT01848704|147348759|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0.18|TWO_SIDED|95.0|-0.95|0.19|||Mixed Models Analysis|||||0.19|-0.95|0.18
73909466|NCT01848704|147348760|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.029|TWO_SIDED|95.0|0.08|1.47|||Mixed Models Analysis|||||1.47|0.08|0.029
73909467|NCT01848704|147348761|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.061|TWO_SIDED|95.0|-0.03|1.31|||Mixed Models Analysis|||||1.31|-0.03|0.061
74026418|NCT03439345|147606169|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for the baseline visual acuity.|Mean Difference (Final Values)|0.0||||0.36|TWO_SIDED|95.0|-0.01|0.01|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||0.01|-0.01|0.36
73909468|NCT03488355|147348797|SUPERIORITY||Risk Ratio (RR)|1.15||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
73909469|NCT02128932|147348984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-0.96|-0.67|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated measurements with treatment , country and stratum as fixed factors and baseline value as covariate, all nested within visit.||-0.67|-0.96|<0.0001
74026419|NCT03439345|147606170|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline VFQ-25 composite score.|Mean Difference (Final Values)|0.0||||0.58|TWO_SIDED|95.0|-1.0|1.0|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||1|-1|0.58
74026420|NCT03439345|147606171|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline EQ-5D Index Score.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.02|0.02|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||0.02|-0.02|0.93
73909470|NCT02128932|147348984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95 % confidence interval for the estimated treatment difference between semaglutide 0.5 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3%).|Treatment difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.52|-0.24|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated meausrements with treatment, country and stratum value as covariate, all nested within visit.||-0.24|-0.52|<0.0001
73909471|NCT01361568|147348992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|3.64|<|0.05|TWO_SIDED|95.0|-15.14|-0.78|||t-test, 2 sided|||||-0.78|-15.14|<0.05
73909472|NCT01361568|147348993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-420.0|STANDARD_ERROR_OF_MEAN|139.16|<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
73909473|NCT01361568|147348993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-230.1|STANDARD_ERROR_OF_MEAN|92.26|<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73909474|NCT01361568|147348993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-260.4|STANDARD_ERROR_OF_MEAN|141.99||0.068||95.0|||||t-test, 2 sided|||||||0.068
73909475|NCT01361568|147348994|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|2.63|<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
73909476|NCT01361568|147348994|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.31|STANDARD_ERROR_OF_MEAN|1.74||0.059||95.0|||||Mixed Models Analysis|||||||0.059
73909477|NCT01361568|147348995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.41|<|0.05|TWO_SIDED|95.0|0.22|1.82|||t-test, 2 sided|||||1.82|0.22|<0.05
73909478|NCT01361568|147348995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.27|<|0.05|TWO_SIDED|95.0|0.11|1.17|||t-test, 2 sided|||||1.17|0.11|<0.05
73909479|NCT01361568|147348996|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|Degrees of freedom (df = 1)||||||0.001
73909480|NCT01361568|147348997|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
73909481|NCT01361568|147348998|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
73909482|NCT00657358|147349000|SUPERIORITY_OR_OTHER||R^2 (adj)|0.477|||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|DF=2 DFDEN=371.8, F-ratio=10.66||||||<0.001
73909483|NCT01254630|147349005|SUPERIORITY||Vaccine Efficacy|0.636|||||TWO_SIDED|97.5|0.364|0.791|||||Point estimate and 97.5% CI of vaccine efficacy (primary endpoint) were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 97.5% Confidence Interval (CI) be \>0.25.||0.791|0.364|
73909484|NCT01254630|147349006|OTHER||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-1.8|4.5||||||||4.5|-1.8|
73909485|NCT01254630|147349007|OTHER||Vaccine Efficacy|0.771|||||TWO_SIDED|95.0|0.48|0.899|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.899|0.480|
73909486|NCT01254630|147349008|OTHER||Vaccine Efficacy|0.874|||||TWO_SIDED|95.0|-0.005|0.984|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.984|-0.005|
73909487|NCT01254630|147349009|OTHER||Vaccine Efficacy|0.746|||||TWO_SIDED|95.0|-1.275|0.972|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.972|-1.275|
73909488|NCT01254630|147349010|OTHER||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-0.6|1.6||||||||1.6|-0.6|
73909489|NCT02959983|147349011|SUPERIORITY|||||||0.0022|||||||Chi-squared|||Overall Weeks 1-12||||0.0022
73909490|NCT02959983|147349012|SUPERIORITY|||||||0.0119|||||||Chi-squared|||Overall Weeks 1 to 12||||0.0119
73909491|NCT02959983|147349012|SUPERIORITY|||||||0.0048|||||||Chi-squared|||Weeks 1 to 4||||0.0048
73909492|NCT02959983|147349012|SUPERIORITY|||||||0.0207|||||||Chi-squared|||Weeks 5 to 8||||0.0207
73909493|NCT02959983|147349012|SUPERIORITY|||||||0.37|||||||Chi-squared|||Weeks 9 to 12||||0.3700
73909494|NCT02959983|147349013|SUPERIORITY|||||||0.0174|||||||Chi-squared|||Overall Weeks 1 to 12||||0.0174
73909495|NCT02959983|147349013|SUPERIORITY|||||||0.3832|||||||Chi-squared|||Weeks 1 to 4||||0.3832
73909496|NCT02959983|147349013|SUPERIORITY|||||||0.0052|||||||Chi-squared|||Weeks 5 to 8||||0.0052
73909497|NCT02959983|147349013|SUPERIORITY|||||||0.0619|||||||Chi-squared|||Weeks 9 to 12||||0.0619
73909498|NCT02959983|147349014|SUPERIORITY|||||||0.033|||||||Chi-squared|||Weeks 1-4||||0.0330
73909499|NCT02959983|147349014|SUPERIORITY|||||||0.0063|||||||Chi-squared|||Weeks 5 to 8||||0.0063
73909500|NCT02959983|147349014|SUPERIORITY|||||||0.0018|||||||Chi-squared|||Weeks 9 to 12||||0.0018
73909501|NCT02495831|147349063|SUPERIORITY_OR_OTHER||point estimate (ratio of geometric means|90.0||||0.1|TWO_SIDED|90.0|80.0|125.0||If the upper limit of the 90% confidence interval is \< 125.00%, no effect of safinamide on diclofenamic acid bioavailability is present (no interaction present).|ANOVA|||The PK parameters AUC0-t and Cmax were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.||125|80|0.1
73909502|NCT02495831|147349064|SUPERIORITY_OR_OTHER||geometric mean ratio|104.84|||||TWO_SIDED|90.0|96.4|114.02||||||||114.02|96.40|
73909503|NCT03789396|147349068|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.14||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Logistic|||Comparison of patient odds of being hyperoxic and not on room air pre- versus post-intervention||0.97|0.57|0.03
73909504|NCT01313858|147349083|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||0.0007
73909505|NCT01313858|147349083|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||0.0007
73909506|NCT01313858|147349083|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||0.0011
73909507|NCT01313858|147349083|SUPERIORITY_OR_OTHER|||||||0.0015|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||0.0015
73909508|NCT01313858|147349083|SUPERIORITY_OR_OTHER|||||||0.0029|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||0.0029
73909509|NCT01313858|147349083|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||0.0004
73909510|NCT01313858|147349083|SUPERIORITY_OR_OTHER|||||||0.0059|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||0.0059
73909511|NCT01313858|147349083|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||0.0002
73909512|NCT01313858|147349083|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||0.0002
73909513|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||<0.0001
73909514|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||<0.0001
73909515|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||<0.0001
74026421|NCT03439345|147606172|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline EQ-5D Visual Analogue Score.|Mean Difference (Final Values)|-1.0||||0.43|TWO_SIDED|95.0|-2.0|1.0|||Regression, Cox|||The estimates were derived from a linear mixed model repeated measures||1|-2|0.43
73909516|NCT01313858|147349083|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||0.0002
74088492|NCT01272921|147730370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-15.0|-6.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-6.00|-15.00|0.05
73909517|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||<0.0001
73909518|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||<0.0001
73909519|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||<0.0001
73909520|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||<0.0001
73909521|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||<0.0001
73909522|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||<0.0001
73909523|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||<0.0001
73909524|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||<0.0001
73909525|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||<0.0001
73909526|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||<0.0001
73909527|NCT01313858|147349083|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||<0.0001
73909528|NCT01313858|147349084|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||0.0003
73909529|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
73909530|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
73909531|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
73909532|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
73909533|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||<0.0001
73909534|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
73909535|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
73909536|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
74026422|NCT03439345|147606173|OTHER||Mean Difference (Final Values)|-254.0|||||TWO_SIDED|95.0|-1062.0|624.0||||||||624|-1062|
74026423|NCT03439345|147606174|OTHER||Incremental cost-effectiveness ratio|614.0|||||TWO_SIDED||||||||£614 cost per QALY gained based on probabilistic analysis|||||
73909537|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
73909538|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||<0.0001
73909539|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
73909540|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
73909541|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
73909542|NCT01313858|147349084|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
73909543|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
73909544|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
73909545|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
73909546|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
74026424|NCT03439345|147606175|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.58|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.58|
74026425|NCT03439345|147606176|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.4|1.0||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.00|0.40|
73909547|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
73909548|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
73909549|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
73909550|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
73909551|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
73909552|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
73909553|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
73909554|NCT01313858|147349085|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
73909555|NCT02899299|147349090|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.74||||0.002|TWO_SIDED|96.6|0.6|0.91||Boundary for statistical significance was a p-value \< 0.0345|Stratified Log Rank|This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT|Stratified Cox proportional hazard model|||0.91|0.60|0.0020
73909556|NCT02899299|147349093|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.77|1.13|||||Stratified Cox proportional hazard model|||1.13|0.77|
73909557|NCT02899299|147349094|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.64|1.32||||||\<1% PD-L1||1.32|0.64|
73909558|NCT02899299|147349094|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.59|0.88||||||≥1% PD-L1||0.88|0.59|
73909559|NCT02899299|147349095|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|1.79|||||TWO_SIDED|95.0|1.22|2.63||||||\< 1% PD-L1||2.63|1.22|
73909560|NCT02899299|147349095|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.61|0.96||||||≥1% PD-L1||0.96|0.61|
73909561|NCT02899299|147349097|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.74||||0.0008|TWO_SIDED|95.0|0.62|0.88|||Stratified Log Rank|This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT|Stratified Cox proportional hazard model|||0.88|0.62|0.0008
73909562|NCT01935791|147349098|OTHER||||||<|0.01||||||The p-values were adjusted for multiple comparisons. The a priori threshold for statistical significance is p\<0.05.|ANOVA|plus Tukey test||||||<0.01
73909563|NCT01935791|147349099|OTHER||||||<|0.001|||||||ANOVA|plus Tukey test||||||<0.001
73909564|NCT02468232|147349101|SUPERIORITY||Hazard Ratio (HR)|1.0881||||0.626|TWO_SIDED|95.0|0.6501|1.8212|||Regression, Cox|||For Primary Composite||1.8212|0.6501|0.6260
74026426|NCT03439345|147606177|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.52|0.97||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.97|0.52|
73909565|NCT02468232|147349101|SUPERIORITY||Hazard Ratio (HR)|1.1701||||0.6493|TWO_SIDED|95.0|0.5242|2.6122|||Regression, Cox|||For CV Death||2.6122|0.5242|0.6493
73909566|NCT02468232|147349101|SUPERIORITY||Hazard Ratio (HR)|1.2673||||0.7851|TWO_SIDED|95.0|0.7039|2.2818|||Regression, Cox|||For 1st HF Hospitalization||2.2818|0.7039|0.7851
73909567|NCT02468232|147349102|SUPERIORITY||LSM of ratio|0.8657||||0.0326|TWO_SIDED|95.0|0.7585|0.988||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure ANCOVA model||Week 4 analysis||0.9880|0.7585|0.0326
73909568|NCT02468232|147349102|SUPERIORITY||LSM of ratio|0.8538||||0.0161|TWO_SIDED|95.0|0.7509|0.9708||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure ANCOVA model||Week 8 analysis||0.9708|0.7509|0.0161
73909569|NCT02468232|147349102|SUPERIORITY||LSM of ratio|0.8112||||0.0104|TWO_SIDED|95.0|0.6916|0.9514||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure of ANCOVA model||Month 6 analysis||0.9514|0.6916|0.0104
73909570|NCT02468232|147349104|SUPERIORITY||Hazard Ratio (HR)|1.024||||0.5406|TWO_SIDED|95.0|0.6492|1.6152|||Regression, Cox|||First triple composite endpoint||1.6152|0.6492|0.5406
74088493|NCT01272921|147730370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-10.0|-4.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-4.00|-10.00|0.05
73909571|NCT02468232|147349104|SUPERIORITY||Hazard Ratio (HR)|1.1701||||0.6493|TWO_SIDED|95.0|0.5242|2.6122|||Regression, Cox|||CV health||2.6122|0.5242|0.6493
73909572|NCT02468232|147349104|SUPERIORITY||Hazard Ratio (HR)|0.8546||||0.3448|TWO_SIDED|95.0|0.3952|1.8479|||Regression, Cox|||First worsening of HF in outpatient||1.8479|0.3952|0.3448
73909573|NCT02468232|147349105|SUPERIORITY|||||||0.7115|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Week 4 analysis||||0.7115
73909574|NCT02468232|147349105|SUPERIORITY|||||||0.1752|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Week 8 analysis||||0.1752
73964793|NCT03089125|147465268|SUPERIORITY||Between-group diff in change per 8 weeks|0.38||||0.677|TWO_SIDED|95.0|-1.4|2.16|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||2.16|-1.40|0.677
73964794|NCT03089125|147465269|SUPERIORITY||Between-group diff in change per 8 weeks|-1.95||||0.33|TWO_SIDED|95.0|-5.87|1.97|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||1.97|-5.87|0.330
73909575|NCT02468232|147349105|SUPERIORITY|||||||0.2688|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Month 6 analysis||||0.2688
73909576|NCT02468232|147349106|SUPERIORITY||LSM of difference|2.5455||||0.1854|TWO_SIDED|95.0|-1.2306|6.3216|||ANCOVA|Repeated measure ANCOVA model||Week 8 analysis||6.3216|-1.2306|0.1854
73909577|NCT02468232|147349106|SUPERIORITY||LSM of difference|1.2695||||0.5737|TWO_SIDED|95.0|-3.1715|5.7104|||ANCOVA|Repeated measure ANCOVA model||Month 6 analysis||5.7104|-3.1715|0.5737
73909578|NCT02468232|147349107|SUPERIORITY||rate ratio|0.8699||||0.6501||95.0|0.4763|1.5887|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.5887|0.4763|0.6501
73909579|NCT02468232|147349108|SUPERIORITY|||||||0.6211|||||||Cochran-Mantel-Haenszel|||||||0.6211
73909580|NCT02468232|147349110|SUPERIORITY||Hazard Ratio (HR)|1.1895||||0.6955|TWO_SIDED|95.0|0.6116|2.3134|||Regression, Cox|||||2.3134|0.6116|0.6955
73909581|NCT02468232|147349112|SUPERIORITY||Rate ratio|1.0192||||0.9233|TWO_SIDED|95.0|0.6925|1.4999|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.4999|0.6925|0.9233
73909582|NCT02468232|147349113|SUPERIORITY||Rate ratio|1.0754||||0.9272|TWO_SIDED|95.0|0.2264|5.1067|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||5.1067|0.2264|0.9272
73964795|NCT03089125|147465270|SUPERIORITY||Between-group diff in change per 8 weeks|0.73||||0.098|TWO_SIDED|95.0|-0.13|1.59|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||1.59|-0.13|0.098
73909583|NCT02468232|147349115|SUPERIORITY||Rate ratio|0.4504||||0.0697|TWO_SIDED|95.0|0.1902|1.0665||Negative binomial (NB) regression model|Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.0665|0.1902|0.0697
73909584|NCT00617851|147349150|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.09|||||TWO_SIDED|95.0|0.92|1.29|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H01 LotA ≠ LotB versus H1 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% confidence interval (CI) on the geometric mean titer (GMT) ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.29|0.92|
73930961|NCT00280566|147391713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.32||0.5771|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5771
73930962|NCT01147653|147391714|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.72|TWO_SIDED|95.0|-2.6|3.7|||t-test, 2 sided|||H0: The true mean 1-year change in GMFM-66 is the same on Autologous Umbilical Cord Blood and Placebo||3.7|-2.6|0.72
73930963|NCT01147653|147391715|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
73909585|NCT00617851|147349150|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.1|||||TWO_SIDED|95.0|0.93|1.31|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H02 LotA ≠ LotC versus H12 LotA = Lotc H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.31|0.93|
73909586|NCT00617851|147349150|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.01|||||TWO_SIDED|95.0|0.85|1.2|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.2|0.85|
73930964|NCT01147653|147391716|SUPERIORITY|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.473
73930965|NCT01147653|147391716|SUPERIORITY|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Bodily Pain/Discomfort change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.377
73930966|NCT01147653|147391716|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Family Cohesion change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.844
73930967|NCT01147653|147391716|SUPERIORITY|||||||0.322|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.322
74026427|NCT03439345|147606178|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.55|1.07||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.07|0.55|
74026428|NCT03439345|147606179|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.51|1.21||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.21|0.51|
74026429|NCT03439345|147606180|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.54|0.93||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.93|0.54|
74026430|NCT03439345|147606181|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.28|0.93||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.93|0.28|
74026431|NCT03439345|147606182|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.6|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.60|
74026432|NCT03439345|147606183|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.49|0.95||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.95|0.49|
74026433|NCT03439345|147606184|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.53|1.06||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.06|0.53|
74026434|NCT03439345|147606185|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.55|3.57||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||3.57|0.55|
74026435|NCT03439345|147606186|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.03||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.03|0.48|
74026436|NCT03439345|147606187|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.56|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.56|
74026437|NCT03439345|147606188|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for the baseline UACR.|Hazard Ratio (HR)|-12.4|||||TWO_SIDED|95.0|-25.8|3.5|||||Estimates are in %.|Linear mixed model repeated measures analyses were conducted to estimate the trial-averaged percentage difference in geometric mean UACR between the randomised treatment groups. UACR data at baseline was available for 312 participants allocated fenofibrate and 310 participants allocated placebo.||3.5|-25.8|
74026438|NCT03439345|147606189|SUPERIORITY|"Adjusted for baseline covariates used in minimised randomisation.~."|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.69|1.6||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.60|0.69|
74026439|NCT03439345|147606190|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.11|1.12||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.12|0.11|
73909587|NCT00617851|147349150|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 Strain)|1.12|||||TWO_SIDED|95.0|0.97|1.3|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.3|0.97|
73909588|NCT00617851|147349150|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.98|||||TWO_SIDED|95.0|0.85|1.13|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.13|0.85|
73909589|NCT00617851|147349150|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.87|||||TWO_SIDED|95.0|0.76|1.01|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.01|0.76|
74026440|NCT05635838|147606192|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.506||0.0215|TWO_SIDED|95.0|-2.21|-0.18|||ANCOVA|||||-0.18|-2.21|0.0215
74026441|NCT05635838|147606194|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.485||0.1671|TWO_SIDED|95.0|-1.65|0.29|||ANCOVA|||||0.29|-1.65|0.1671
74026442|NCT05635838|147606195|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.728||0.7982|TWO_SIDED|95.0|-1.27|1.64|||ANCOVA|||||1.64|-1.27|0.7982
74026443|NCT05635838|147606196|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|0.94|STANDARD_ERROR_OF_MEAN|0.73||0.2031|TWO_SIDED|95.0|-0.52|2.4|||ANCOVA|||||2.40|-0.52|0.2031
74085283|NCT00112294|147724276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.2358|TWO_SIDED|95.0|0.761|1.069||Since only 1 primary comparison was conducted, no adjustment for multiple comparisons was needed.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model, with treatment as the single covariate.|Confidence intervals calculated using Brookmeyer and Crowley method. Primary analysis was comparison of PFS between arms performed by 2-sided alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that PFS was equal in both groups. Power calculations indicated that \>=510 events (IRRC progressions/deaths) would lead to \>=90% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.75.||1.069|0.761|0.2358
74026444|NCT05635838|147606198|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.683||0.2387|TWO_SIDED|95.0|-2.2|0.56|||ANCOVA|||||0.56|-2.20|0.2387
74026445|NCT05165394|147606204|SUPERIORITY||Least-Squares Mean Treatment Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.5||0.8663|ONE_SIDED|90.0|-8.4|||Significance level = 0.1|ANCOVA||Confidence interval and p-value are one-sided for test of null hypothesis that the LS mean difference between NBI-1065846 and placebo in DARS total score at Day 57 is greater than or equal to zero.||||-8.4|0.8663
74026446|NCT05165394|147606205|SUPERIORITY||Least-Squares Mean Treatment Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.0||0.7008|TWO_SIDED|95.0|-7.1|4.8|||ANCOVA||NBI-1065846 - Placebo|||4.8|-7.1|0.7008
74026447|NCT05165394|147606206|SUPERIORITY|||||||0.9051|||||||Cochran-Mantel-Haenszel Chi-square test|||CGI-S scores at Day 57 for NBI-1065846 compared to placebo.||||0.9051
74085284|NCT00112294|147724277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.675||||0.0066|TWO_SIDED|95.0|1.152|2.436|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a Cochran-Mantel-Haenszel (CMH) (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||2.436|1.152|0.0066
73909590|NCT00617851|147349150|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.06|||||TWO_SIDED|95.0|0.91|1.23|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.23|0.91|
73909591|NCT00617851|147349150|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.15|||||TWO_SIDED|95.0|0.99|1.33|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.33|0.99|
73909592|NCT00617851|147349150|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.09|||||TWO_SIDED|95.0|0.94|1.26|||ANOVA||"The control vaccine arm (n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.26|0.94|
73909593|NCT02476201|147349173|SUPERIORITY|Using a one-sided, one sample Exact Binomial Test and a significance level of 2.5%, the study required 74 patients to reach a power of 90%. With the MPP feature activated at baseline, it was assumed that the proportion of responders at 6 months was 75%. The MPP responder rate was compared to 57%, which is the responder rate obtained from literature for patients without the MPP feature activated.|Percentage|67.1||||0.0435|ONE_SIDED|97.5|55.6||||Exact binomial||||||55.6|0.0435
73909594|NCT04289623|147349212|SUPERIORITY||Odds Ratio (OR)|1.19||||0.007|TWO_SIDED|95.0|1.05|1.35||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the standard email as the reference group.||1.35|1.05|.007
73909595|NCT04289623|147349212|SUPERIORITY||Odds Ratio (OR)|0.82||||0.287|TWO_SIDED|95.0|0.56|1.19||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the standard email as the reference group.||1.19|0.56|.287
73909596|NCT04289623|147349212|SUPERIORITY||Odds Ratio (OR)|1.05||||0.59|TWO_SIDED|95.0|0.87|1.27||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the rank-and-file email as the reference group.||1.27|0.87|.590
73909597|NCT04289623|147349212|SUPERIORITY||Odds Ratio (OR)|1.86||||0.035|TWO_SIDED|95.0|1.05|3.32||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the rank-and-file email as the reference group.||3.32|1.05|.035
73909598|NCT04289623|147349213|SUPERIORITY||Odds Ratio (OR)|1.16||||0.085|TWO_SIDED|95.0|0.98|1.37||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the standard email as the reference group.||1.37|0.98|.085
73909599|NCT04289623|147349213|SUPERIORITY||Odds Ratio (OR)|0.89||||0.569|TWO_SIDED|95.0|0.6|1.33||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the standard email as the reference group.||1.33|0.60|.569
73909600|NCT04289623|147349213|SUPERIORITY||Odds Ratio (OR)|0.79||||0.24|TWO_SIDED|95.0|0.54|1.17||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the rank-and-file email as the reference group.||1.17|0.54|.240
73930968|NCT01147653|147391716|SUPERIORITY|||||||0.927|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Health Perceptions change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.927
74085285|NCT00112294|147724278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.265||||0.1501|TWO_SIDED|95.0|0.918|1.741|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||1.741|0.918|0.1501
73857787|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3515|TWO_SIDED|90.0|-0.18|0.65|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.65|-0.18|0.3515
73857788|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.3788|TWO_SIDED|90.0|-0.64|0.19|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.19|-0.64|0.3788
73857789|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.28||0.0044|TWO_SIDED|90.0|0.35|1.29|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||1.29|0.35|0.0044
73857790|NCT01730339|147260727|SUPERIORITY_OR_OTHER||Least Square mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.6848|TWO_SIDED|90.0|-0.35|0.58|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.58|-0.35|0.6848
73857791|NCT01730339|147260728|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.32||0.7552|TWO_SIDED|90.0|-0.44|0.64|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.64|-0.44|0.7552
73857792|NCT01730339|147260728|SUPERIORITY_OR_OTHER||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.25||0.6605|TWO_SIDED|90.0|-0.3|0.52|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.30|0.6605
73857793|NCT01730339|147260728|SUPERIORITY_OR_OTHER||Least Square mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.9842|TWO_SIDED|90.0|-0.55|0.56|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.56|-0.55|0.9842
73857794|NCT01730339|147260728|SUPERIORITY_OR_OTHER||Least Square mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.25||0.401|TWO_SIDED|90.0|-0.21|0.63|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.63|-0.21|0.4010
73857795|NCT01730339|147260728|SUPERIORITY_OR_OTHER||Least Square mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.38||0.2491|TWO_SIDED|90.0|-0.19|1.07|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.07|-0.19|0.2491
73857796|NCT01730339|147260728|SUPERIORITY_OR_OTHER||Least Square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.998|TWO_SIDED|90.0|-0.47|0.47|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.47|-0.47|0.9980
73857797|NCT01730339|147260728|SUPERIORITY_OR_OTHER||Least Square mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.39||0.473|TWO_SIDED|90.0|-0.37|0.93|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.93|-0.37|0.4730
73857798|NCT01730339|147260728|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.3||0.5413|TWO_SIDED|90.0|-0.67|0.31|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.31|-0.67|0.5413
73857799|NCT01730339|147260729|SUPERIORITY_OR_OTHER||Least Square mean difference|1.32|STANDARD_ERROR_OF_MEAN|2.76|||TWO_SIDED|90.0|-3.28|5.92||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||5.92|-3.28|
73857800|NCT01730339|147260729|SUPERIORITY_OR_OTHER||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-3.63|2.91||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||2.91|-3.63|
73857801|NCT01730339|147260729|SUPERIORITY_OR_OTHER||Least Square mean difference|3.82|STANDARD_ERROR_OF_MEAN|3.85|||TWO_SIDED|90.0|-2.6|10.24||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||10.24|-2.60|
73857802|NCT01730339|147260729|SUPERIORITY_OR_OTHER||Least Square mean difference|0.16|STANDARD_ERROR_OF_MEAN|2.72|||TWO_SIDED|90.0|-4.37|4.68||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||4.68|-4.37|
73857803|NCT01730339|147260729|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|2.19|||TWO_SIDED|90.0|-4.34|2.95||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||2.95|-4.34|
73857804|NCT01730339|147260729|SUPERIORITY_OR_OTHER||Least Square mean difference|-1.54|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|90.0|-4.53|1.45||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.45|-4.53|
73857805|NCT01730339|147260729|SUPERIORITY_OR_OTHER||Least Square mean difference|1.75|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|90.0|-2.07|5.58||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||5.58|-2.07|
73857806|NCT01730339|147260729|SUPERIORITY_OR_OTHER||Least Square mean difference|-1.13|STANDARD_ERROR_OF_MEAN|1.87|||TWO_SIDED|90.0|-4.24|1.99||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.99|-4.24|
73857807|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.15|0.35||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.35|-0.15|
73964796|NCT03089125|147465271|SUPERIORITY||Between-group diff in change per 8 weeks|0.08||||0.845|TWO_SIDED|95.0|-0.76|0.93|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||0.93|-0.76|0.845
73964797|NCT03089125|147465272|SUPERIORITY||Between-group diff in change per 8 weeks|0.74||||0.837|TWO_SIDED|95.0|-6.33|7.77|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||7.77|-6.33|0.837
73964798|NCT04310735|147465276|OTHER|Independent-samples t-tests were conducted to compare the mean contrast of parameter estimate (COPE) values, derived from the contrast of smoking-related versus neutral cue activation, between the Expect-Yes and Expect-No groups in the ventromedial prefrontal cortex region of interest.||||||0.13||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||0.13
73964799|NCT04310735|147465276|OTHER|Independent-samples t-tests were conducted to compare the mean contrast of parameter estimate (COPE) values, derived from the contrast of smoking-related versus neutral cue activation, between the Expect-Yes and Expect-No groups in the dorsal anterior cingulate cortex region of interest.||||||0.25||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||.25
73964800|NCT04310735|147465277|OTHER|Independent-samples t-tests were conducted to compare mean valence values during smoking-related cues between the Expect-Yes and Expect-No groups.||||||0.8|||||||t-test, 2 sided|Statistical significance was defined a priori as p\<0.05.||The null hypothesis was that there is no difference in the population means of the two groups.||||.80
73964801|NCT04310735|147465277|OTHER|Independent-samples t-tests were conducted to compare mean valence values during neutral cues between the Expect-Yes and Expect-No groups.||||||0.87||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||.87
73857808|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.22|0.29||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.29|-0.22|
73857809|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.04|0.54||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.54|0.04|
73964802|NCT04605198|147465332|SUPERIORITY|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.|Mean Difference (Net)|-0.58||||0.846|TWO_SIDED|95.0|-6.46|5.29|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|||5.29|-6.46|.846
73964803|NCT04605198|147465333|SUPERIORITY||Mean Difference (Net)|-1.88||||0.139|TWO_SIDED|95.0|-4.36|0.6|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||0.60|-4.36|.139
73964804|NCT04605198|147465334|SUPERIORITY||Mean Difference (Net)|-0.12||||0.222|TWO_SIDED|95.0|-1.21|0.97|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||0.97|-1.21|.222
73964805|NCT04605198|147465335|SUPERIORITY||Odds Ratio, log|-1.76||||0.166|TWO_SIDED|95.0|-4.26|0.73|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed using a logit distribution. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was included as a fixed-effect. An independent covariance pattern was specified. Final models were random-intercept only.||0.73|-4.26|0.166
73964806|NCT04605198|147465336|SUPERIORITY||Mean Difference (Net)|-0.52||||0.737|TWO_SIDED|95.0|-3.57|2.53|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||2.53|-3.57|.737
74088494|NCT01272921|147730370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-7.0|-2.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-2.00|-7.00|0.05
73909601|NCT04289623|147349213|SUPERIORITY||Odds Ratio (OR)|0.94||||0.871|TWO_SIDED|95.0|0.45|1.95||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the rank-and-file email as the reference group.||1.95|0.45|.871
73909602|NCT03758443|147349214|SUPERIORITY||Least Square Mean Difference|-0.27||||0.5809|TWO_SIDED|95.0|-1.22|0.69|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.69|-1.22|0.5809
73909603|NCT03758443|147349214|SUPERIORITY||Least Square Mean Difference|-0.37||||0.4501|TWO_SIDED|95.0|-1.33|0.59|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.59|-1.33|0.4501
73909604|NCT03758443|147349214|SUPERIORITY||Least Square Mean Difference|-0.65||||0.1809|TWO_SIDED|95.0|-1.6|0.3|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.30|-1.60|0.1809
73909605|NCT03758443|147349215|SUPERIORITY|||||||0.3762|||||||Fisher Exact|||||||0.3762
73909606|NCT03758443|147349215|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
73909607|NCT03758443|147349215|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
73909608|NCT03758443|147349216|SUPERIORITY||Difference in Proportion|0.0||||0.9542|TWO_SIDED|95.0|-0.104|0.11||P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.110|-0.104|0.9542
73909609|NCT03758443|147349216|SUPERIORITY||Difference in Proportion|-0.03||||0.5863|TWO_SIDED|95.0|-0.126|0.071||P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.071|-0.126|0.5863
73909610|NCT03758443|147349216|SUPERIORITY||Difference in Proportion|-0.03||||0.5408|TWO_SIDED|95.0|-0.131|0.069||P-value is shown for Conhran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.069|-0.131|0.5408
73909611|NCT03758443|147349217|SUPERIORITY|||||||0.6656|||||||Fisher Exact|||||||0.6656
73909612|NCT03758443|147349217|SUPERIORITY|||||||0.6424|||||||Fisher Exact|||||||0.6424
74088495|NCT02129647|147730387|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 122 (60 to 265)|||
73909613|NCT03758443|147349217|SUPERIORITY|||||||0.6199|||||||Fisher Exact|||||||0.6199
73909614|NCT03758443|147349218|SUPERIORITY|||||||0.2643|||||||Fisher Exact|||||||0.2643
73909615|NCT03758443|147349218|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
73909616|NCT03758443|147349218|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
73909617|NCT03758443|147349219|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
73909618|NCT03758443|147349219|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
73909619|NCT03758443|147349219|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
73909620|NCT03080454|147349220|EQUIVALENCE|Statistical analysis for mean percent change from baseline in area under the curve for the resistance torque measure across 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean percent change in area under the curve between anodal and sham Doublestim conditions. A significance level of 0.05 was used (two-sided).||||||0.004||||||A 2x2 repeated measures ANOVA was performed with condition (mean percent change in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.004
73909621|NCT03080454|147349221|EQUIVALENCE|Statistical analysis for mean Tardieu Scale Score summed across 11 joints of the upper extremity in 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean change between anodal and sham Doubleestim conditions. A significance level of 0.05 was used (two-sided).||||||0.003||||||A 2x2 repeated measures ANOVA was performed with condition (mean score in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.003
73909622|NCT01436396|147349222|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 95% Confidence Interval (CI) was greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|0.334|||||TWO_SIDED|95.0|-0.976|1.87||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).||1.87|-0.976|
73909623|NCT01436396|147349223|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 95% CI is greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|-1.06|||||TWO_SIDED|95.0|-2.81|0.383||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).||0.383|-2.81|
73909624|NCT00216476|147349236|SUPERIORITY_OR_OTHER||||||<|0.0001||||||threshold for significance: 0.05 (2-sided)|Log Rank|||Null hypothesis was that there is no difference in treatment effect between risperidone LAI and quetiapine by mean relapse free period; given a estimated relapse rate of 30% for risperidone LAI and 42% for quetiapine, with 80% power and 5% 2-tailed significance level, 251 subjects were needed per treatment arm. To adjust for an estimated 20% discontinuations for reasons other than relapse, 628 subjects in total were needed. Actual relapse rates were 17% (risperidone LAI) and 31% (quetiapine).||||<0.0001
73930969|NCT01147653|147391716|SUPERIORITY|||||||0.199|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Global Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.199
74088496|NCT02129647|147730388|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 135 (100 to 240)|||
74088497|NCT02129647|147730389|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 12 (0 to 100)|||
73909625|NCT00216476|147349238|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.0001
73909626|NCT00216476|147349238|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
73909627|NCT00216476|147349238|SUPERIORITY_OR_OTHER|||||||0.1026|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.||||0.1026
73909628|NCT00216476|147349239|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||<0.0001
73909629|NCT00216476|147349239|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||<0.0001
73909630|NCT00216476|147349239|SUPERIORITY_OR_OTHER|||||||0.0446|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||0.0446
73909631|NCT00216476|147349240|SUPERIORITY_OR_OTHER|||||||0.0941|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||0.0941
73909632|NCT00216476|147349240|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
73909633|NCT00216476|147349240|SUPERIORITY_OR_OTHER|||||||0.1146|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||0.1146
73909634|NCT00216476|147349240|SUPERIORITY_OR_OTHER|||||||0.5589|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||0.5589
73909635|NCT00216476|147349240|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
73909636|NCT00216476|147349240|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
73909637|NCT00696800|147349266|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Treatment groups were formally compared with a generalized linear model for the ongoing pregnancy rate which included factors for treatment group, age at randomization, and region. A pre-defined non-inferiority margin of 8% was applied.|Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-3.8|5.9||||||||5.9|-3.8|
73909638|NCT00696800|147349267|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margins of -3 and +5 were applied for the difference in number of oocytes. If the 95% confidence interval of the difference exceeded -3 or +5 oocytes, then Corifollitropin Alfa treatment was not considered equivalent to the reference treatment (recFSH).|Mean Difference (Final Values)|1.2||||0.001|TWO_SIDED|95.0|0.5|1.9||Treatment groups were formally compared including covariates treatment group, age and center.|ANOVA|||||1.9|0.5|0.001
73909639|NCT02387710|147349289|OTHER||||||>|0.5|||||||Wilcoxon (Mann-Whitney)|||||||>0.5
73909640|NCT01044706|147349292|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\<0.05).|ratio of T/R geometric mean x 100|108.46|STANDARD_ERROR_OF_MEAN|0.0321|<|0.05|TWO_SIDED|90.0|102.79|114.44||Differences were declared statistically significant at the 5% level (p\<0.05).|ANOVA|degrees of freedom 55|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed AUC0-144 at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for AUC0-144 hour.||114.44|102.79|<0.05
73930970|NCT01147653|147391716|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Growth and Development change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.294
73930971|NCT01147653|147391716|SUPERIORITY|||||||0.726|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Overall Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.726
73930972|NCT01147653|147391716|SUPERIORITY|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Emotional change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.315
73909641|NCT01044706|147349293|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\<0.05).|ratio of T/R geometric mean x 100|110.5|STANDARD_ERROR_OF_MEAN|0.0281|<|0.05|TWO_SIDED|95.0|105.43|115.82||Differences were declared statistically significant at the 5% level (p\<0.05).|ANOVA|degrees of freedom 56|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed Cmax at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for Cmax.||115.82|105.43|<0.05
73909642|NCT02913612|147349301|SUPERIORITY||Odds Ratio, log|2.65||||0.0205|TWO_SIDED|95.0|1.12|6.26|||Fisher Exact|||||6.26|1.12|0.0205
73909643|NCT02913612|147349301|SUPERIORITY||Odds Ratio, log|2.16||||0.0619|TWO_SIDED|95.0|0.91|5.14|||Fisher Exact|||||5.14|0.91|0.0619
73909644|NCT02913612|147349301|SUPERIORITY||Odds Ratio, log|1.23||||0.6281|TWO_SIDED|95.0|0.53|2.82|||Fisher Exact|||||2.82|0.53|0.6281
73909645|NCT00973674|147349322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Barnard's unconditional Exact Test|||||||0.99
73909646|NCT00973674|147349323|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.67||||0.033|TWO_SIDED|95.0|0.74|3.77|||Log Rank|||||3.77|0.74|.033
73909647|NCT00973674|147349324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|||||||t-test, 2 sided|||||||.35
73964807|NCT04605198|147465337|SUPERIORITY||Mean Difference (Net)|-2391.98||||0.024|TWO_SIDED|95.0|-4471.46|-312.49|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||-312.49|-4471.46|.024
73964808|NCT04038957|147465338|SUPERIORITY|||||||0.0072||||||A p-value of p\<0.05 will be considered as significant.|Repeated Measures ANOVA|||To examine the primary outcome, the effects of SEP-363856 on the striatum, a repeated measures ANOVA model will be build using the baseline and on-treatment kicer values of each striatal subregion.||||0.0072
73909648|NCT00116428|147349327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||The study null hypothesis is that the chronic success rates for the THERMOCOOL and AAD groups are equal.||||<0.001
73909649|NCT02713204|147349332|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|0.02||||0.9894|TWO_SIDED|95.0|-2.99|3.03||Threshold for significance at 0.05 level.|ANCOVA|||||3.03|-2.99|0.9894
73909650|NCT02713204|147349332|SUPERIORITY||Least square mean difference|0.25||||0.8346|TWO_SIDED|95.0|-2.09|2.59|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||2.59|-2.09|0.8346
73909651|NCT02713204|147349333|SUPERIORITY||Least square mean difference|-1.2||||0.4611|TWO_SIDED|95.0|-4.41|2.0||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.00|-4.41|0.4611
73909652|NCT02713204|147349333|SUPERIORITY|Threshold for significance at 0.05 level.|Least square mean difference|-2.0||||0.2225|TWO_SIDED|95.0|-5.22|1.22|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||1.22|-5.22|0.2225
73964809|NCT01998984|147465343|SUPERIORITY||Relative risk|2.97||||0.18|TWO_SIDED|95.0|0.6|14.74||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared participant in the vehicle group."||14.74|0.60|0.18
74026448|NCT05652660|147606207|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|120.5|||||TWO_SIDED|90.0|104.77|138.59|||||The ratios (and 90% CIs) are expressed as percentages.|Rosuvastatin administered alone as the Reference and ARV-471 coadministered with rosuvastatin as the Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||138.59|104.77|
74088498|NCT03923699|147730404|SUPERIORITY||Risk Ratio (RR)|0.96||||0.41|TWO_SIDED|95.0|0.85|1.08||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.08|0.85|0.41
73909653|NCT02713204|147349333|SUPERIORITY||Least square mean difference|-0.82||||0.6063|TWO_SIDED|95.0|-3.97|2.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.32|-3.97|0.6063
73909654|NCT02713204|147349333|SUPERIORITY||Least square mean difference|-3.25||||0.0426|TWO_SIDED|95.0|-6.39|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-0.11|-6.39|0.0426
73909655|NCT02713204|147349333|SUPERIORITY||Least square mean difference|-4.39||||0.0073|TWO_SIDED|95.0|-7.58|-1.19||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-1.19|-7.58|0.0073
74088499|NCT03923699|147730405|SUPERIORITY||Risk Ratio (RR)|1.0||||0.92|TWO_SIDED|95.0|0.92|1.1||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.10|0.92|0.92
74026449|NCT05652660|147606208|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|110.56|||||TWO_SIDED|90.0|103.53|118.06|||||The ratios (and 90% CIs) are expressed as percentages.|Rosuvastatin administered alone as the Reference and ARV-471 coadministered with rosuvastatin as the Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.06|103.53|
74026450|NCT00492622|147606224|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||<|0.01||||||\<0.01 is used for determining the level of significance.|paired t-tests|||||||< 0.01
74026451|NCT00492622|147606225|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||||||||||||||P\<0.05 was used as the level of significance with ANOVA for this endpoint.|||
74026452|NCT00492622|147606226|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.||||||0.95||||||An analysis of variance model was used to compare AUC between IR and DR omeprazole using the natural logarithmic transformation. The model included the following factors: treatment, period, sequence and patient nested within the sequence.|ANOVA|||||||0.95
74026453|NCT01332435|147606227|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74026454|NCT01332435|147606227|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Chi-squared|||||||0.0002
74085286|NCT00112294|147724281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1685|TWO_SIDED|95.0|0.754|1.051||An interim analysis on survival was performed. Final p-value was adjusted using an alpha spending function. At the interim analysis (data not reported here) the type 1 error was 0.0001, and the rest is for the final look.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model with treatment as the single covariate.|Confidence intervals were calculated using Brookmeyer and Crowley method. Analysis was a comparison of survival between groups by means of a 2-sided, alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that survival was equal in both treatment arms. Power calculations indicated that \>= 558 events would lead to at \>=75% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.8.||1.051|0.754|0.1685
74088500|NCT03923699|147730406|SUPERIORITY||Risk Ratio (RR)|0.98||||0.68|TWO_SIDED|95.0|0.89|1.09||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.09|0.89|0.68
73857810|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.36|0.15||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.15|-0.36|
73857811|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.57|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.32|0.82||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.82|0.32|
73857812|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.21|0.3||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.30|-0.21|
73857813|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.18|0.68||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.68|0.18|
73857814|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_DEVIATION|0.15|||TWO_SIDED|90.0|-0.18|0.32||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.32|-0.18|
74026455|NCT01332435|147606228|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74026456|NCT01332435|147606228|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Chi-squared|||||||0.0006
74026457|NCT01332435|147606229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74026458|NCT01332435|147606229|SUPERIORITY_OR_OTHER|||||||0.0699||95.0|||||Chi-squared|||||||0.0699
74026459|NCT01332435|147606230|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
74026460|NCT01332435|147606230|SUPERIORITY_OR_OTHER|||||||0.8645||95.0|||||Regression, Linear|||||||0.8645
74026461|NCT01332435|147606231|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
74026462|NCT01332435|147606231|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
73857815|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.2|0.39||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.39|-0.20|
73857816|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.28|0.23||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.28|
73857817|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.29|0.3||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.30|-0.29|
74026463|NCT01362322|147606245|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-diphtheria (anti-D) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted radio|0.96|||||TWO_SIDED|95.0|0.85|1.09|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to diphteria vaccine antigens, one month after booster vaccination.||1.09|0.85|
74026464|NCT01362322|147606245|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-tetanus (anti-T) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.1|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to tetanus vaccine antigens, one month after booster vaccination.||1.1|0.86|
74085287|NCT00112294|147724282|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Cochran-Mantel-Haenszel|||Improvement of symptoms was compared between groups by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||||0.26
73857818|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.18|0.33||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.33|-0.18|
73857819|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.12|0.72||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.72|0.12|
73857820|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.27|0.24||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.27|
73857821|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.5||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.50|-0.09|
73857822|NCT01730339|147260730|SUPERIORITY_OR_OTHER||Least Square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.11|0.4||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.40|-0.11|
73857823|NCT03095027|147260736|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.05. With a sample size of 10, there was approximately 80% power to reject the null hypothesis of inferiority in visual acuity with assumed standard deviation of 0.0474 (one-sided alpha=0.05)|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0||0.01||||||||0.01||
73857824|NCT00395291|147260771|SUPERIORITY_OR_OTHER||||||<|0.001||||||The IGF-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.|ANCOVA|||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IGF-1 is the same for both the MK-0677 and placebo interventions.~Power calculation: We assumed that the IGF-I data will be lognormally distributed and thus the parameter of interest will be the IGF-1 geometric mean. If n=22 individuals complete the study and the intervention effect is 48% greater for one intervention than the other we will have at least 0.80 power to reject the null hypothesis."||||<0.001
73857825|NCT00395291|147260772|SUPERIORITY_OR_OTHER|||||||0.169|||||||ANCOVA|The Acyl-Ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Acyl-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.169
73857826|NCT00395291|147260773|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANCOVA|The Leptin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in leptin is the same for both the MK-0677 and placebo interventions.~Because Leptin is considered a secondary outcome, no power analysis was conducted."||||0.063
73857827|NCT00395291|147260774|SUPERIORITY_OR_OTHER|||||||0.075|||||||ANCOVA|The insulin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in serum-insulin is the same for both the MK-0677 and placebo interventions.~Because serum-insulin is considered a secondary outcome, no power analysis was conducted."||||0.075
73857828|NCT00395291|147260775|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANCOVA|||||||.782
73857829|NCT00395291|147260776|SUPERIORITY_OR_OTHER|||||||0.385|||||||ANCOVA|The TNF-a data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in TNF-a is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.385
73909656|NCT02713204|147349333|SUPERIORITY||Least square mean difference|1.17||||0.469|TWO_SIDED|95.0|-2.01|4.36||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||4.36|-2.01|0.4690
73909657|NCT02713204|147349333|SUPERIORITY||Least square mean difference|2.42||||0.1267|TWO_SIDED|95.0|-0.69|5.54||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.54|-0.69|0.1267
73909658|NCT02713204|147349334|SUPERIORITY||Least square mean difference|-11.57||||0.413|TWO_SIDED|95.0|-39.5|16.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||16.20|-39.5|0.4130
73909659|NCT02713204|147349334|SUPERIORITY||Least square mean difference|-4.88||||0.6587|TWO_SIDED|95.0|-26.2|16.85|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||16.85|-26.2|0.6587
73909660|NCT02713204|147349335|SUPERIORITY||Least square mean difference|17.04||||0.3833|TWO_SIDED|95.0|-21.35|55.43||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||55.43|-21.35|0.3833
73909661|NCT02713204|147349335|SUPERIORITY||Least square mean difference|12.85||||0.5141|TWO_SIDED|95.0|-25.84|51.53||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||51.53|-25.84|0.5141
73909662|NCT02713204|147349335|SUPERIORITY||Least square mean difference|33.89||||0.0785|TWO_SIDED|95.0|-3.89|71.67|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||71.67|-3.89|0.0785
73909663|NCT02713204|147349335|SUPERIORITY||Least square mean difference|42.27||||0.0281|TWO_SIDED|95.0|4.56|79.98||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||79.98|4.56|0.0281
73857830|NCT00395291|147260777|SUPERIORITY_OR_OTHER|||||||0.929|||||||ANCOVA|The CRPs data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in CRPs is the same for both the MK-0677 and placebo interventions.~Because CRPs is considered as a secondary outcome, no power analysis was conducted."||||0.929
73857831|NCT00395291|147260778|SUPERIORITY_OR_OTHER|||||||0.905|||||||ANCOVA|The IL-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-1 is the same for both the MK-0677 and placebo interventions.~Because IL-1 is considered as a secondary outcome, no power analysis was conducted"||||0.905
73857832|NCT00395291|147260779|SUPERIORITY_OR_OTHER|||||||0.233||95.0|||||ANCOVA|||||||0.233
73857833|NCT00395291|147260780|SUPERIORITY_OR_OTHER|||||||0.277|||||||ANCOVA|The IL-10 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-10 is the same for both the MK-0677 and placebo interventions.~Because IL-10 is considered as a secondary outcome, no power analysis was conducted."||||0.277
73857834|NCT00395291|147260781|SUPERIORITY_OR_OTHER|||||||0.875|||||||ANCOVA|The esterase data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in esterase is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.875
73857835|NCT00395291|147260782|SUPERIORITY_OR_OTHER|||||||0.545|||||||ANCOVA|The adiponectin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in adiponectin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.545
73857836|NCT00395291|147260783|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANCOVA|Total ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Total-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.900
73857837|NCT01962987|147260784|EQUIVALENCE|90% confidence interval of the difference in the percentage of patients between Test and Reference to be contained within -20%, + 20%, using the Per-Protocol Population.|(Test-Ref) Difference|0.68|||||TWO_SIDED|90.0|-8.06|9.42|||||Applicable to Percentage of Subjects with Cure (100% complete AK clearance at day 90)|||9.42|-8.06|
73857838|NCT01962987|147260784|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.0010
73857839|NCT00322023|147260795|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|These are paired t test baseline vs final for the 30 mg/kg dose||||||<0.0001
73857840|NCT00322023|147260795|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|These are paired t test baseline vs final for the 60 mg/kg dose||||||<0.05
73857841|NCT00322023|147260795|SUPERIORITY|These are paired t test baseline vs final for the 120 mg/kg dose|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73857842|NCT00322023|147260796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|TWO_SIDED|95.0||||These are paired t test baseline vs final for 30mg/kg|t-test, 2 sided|||||||0.39
73857843|NCT00322023|147260796|SUPERIORITY||||||<|0.001||||||These are paired t test baseline vs final for 60mg/kg|t-test, 2 sided|||||||<0.001
73857844|NCT00322023|147260796|SUPERIORITY|||||||0.01||||||These are paired t test baseline vs final for 120mg/kg|t-test, 2 sided|||||||0.01
73857845|NCT00523705|147260797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|STANDARD_ERROR_OF_MEAN|4.86||0.467|TWO_SIDED||||||Regression, Linear||estimate of main effect of treatment in a linear mixed effects model.|Pilot data were examined at treatment endpoint for change from baseline. Statistical power was very low due to the small sample size.||||0.467
73857846|NCT01180036|147260807|SUPERIORITY||Risk Difference (RD)|40.0||||0.001|TWO_SIDED|95.0|24.6|55.4|||Chi-squared|||||55.4|24.6|0.001
73857847|NCT01180036|147260808|NON_INFERIORITY|With a non-inferiority margin of 15%. enrollment of 63 evaluable patients per study are is required to achieve 80% power to show that RTX is not inferior.||||||0.009|||||||Chi-squared|||||||0.009
73857848|NCT04243577|147260809|EQUIVALENCE|Margins for this test were calculated as plus or minus half a standard deviation using preliminary data acquired with the conventional electrodes, which were considered as the current gold standard and were ± 3.1.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|t-test, 2 sided|||For Iteration 1 testing, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
73909664|NCT02713204|147349335|SUPERIORITY||Least square mean difference|16.65||||0.3934|TWO_SIDED|95.0|-21.67|54.96||Threshold for significance at 0.05 level.|ANCOVA|||||54.96|-21.67|0.3934
73909665|NCT02713204|147349335|SUPERIORITY||Least square mean difference|21.05||||0.279|TWO_SIDED|95.0|-17.13|59.22||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||59.22|-17.13|0.2790
73909666|NCT02713204|147349335|SUPERIORITY||Least square mean difference|-8.38||||0.6586|TWO_SIDED|95.0|-45.64|28.88||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||28.88|-45.64|0.6586
73909667|NCT02713204|147349336|SUPERIORITY||Least square mean difference|0.55||||0.4889|TWO_SIDED|95.0|-1.01|2.1||Threshold for significance at 0.05 level.|ANCOVA|||||2.10|-1.01|0.4889
73909668|NCT02713204|147349336|SUPERIORITY||Least square mean difference|0.24||||0.7027|TWO_SIDED|95.0|-0.99|1.46||Threshold for significance at 0.05 level.|ANCOVA|||||1.46|-0.99|0.7027
73909669|NCT02713204|147349337|SUPERIORITY||Least square mean difference|-0.6||||0.4927|TWO_SIDED|95.0|-2.34|1.13||Threshold for significance at 0.05 level.|ANCOVA|||||1.13|-2.34|0.4927
73909670|NCT02713204|147349337|SUPERIORITY||Least square mean difference|0.38||||0.6645|TWO_SIDED|95.0|-1.36|2.13||Threshold for significance at 0.05 level.|ANCOVA|||||2.13|-1.36|0.6645
74026465|NCT01362322|147606246|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-pertussis toxoid (anti-PT) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||TWO_SIDED|95.0|0.82|1.04|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertussis toxoid vaccine antigens, one month after booster vaccination.||1.04|0.82|
74026466|NCT01362322|147606246|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-filamentous haemagglutinin (anti-FHA) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||TWO_SIDED|95.0|0.83|1.03||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to filamentous haemagglutinin vaccine antigens, one month after booster vaccination.||1.03|0.83|
74026467|NCT01362322|147606246|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-pertactin (anti-PRN) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted ratio|0.98|||||TWO_SIDED|95.0|0.85|1.13||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertactin vaccine antigens, one month after booster vaccination.||1.13|0.85|
74026468|NCT02413398|147606260|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.15|||Mixed Models Analysis|||Difference in adjusted mean change from baseline (MMRM model)||-0.15|-0.53|<0.001
74026469|NCT02413398|147606261|SUPERIORITY||Mean Difference (Final Values)|-1.43|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.15|-0.69|||Mixed Models Analysis|||Difference in adjusted mean percent change from baseline (MMRM)||-0.69|-2.15|<0.001
74026470|NCT02413398|147606262|SUPERIORITY||Mean Difference (Final Values)|-16.59|STANDARD_ERROR_OF_MEAN|5.15||0.001|TWO_SIDED|95.0|-26.73|-6.45|||Mixed Models Analysis|||Difference in adjusted mean change from baseline versus placebo (MMRM)||-6.45|-26.73|0.001
74026471|NCT02413398|147606263|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.05|TWO_SIDED|95.0|-6.3|0.0|||Mixed Models Analysis|||Difference in adjusted mean change from baseline vs. placebo (MMRM)||0.0|-6.3|<0.050
74026472|NCT05483127|147606330|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, sequence) and random (subject) effects. Difference=P1fA - MDT. Sign (negative or positive) is retained with the rounded value.|||-0.00||
74026473|NCT00315302|147606331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.24||0.21||95.0|-0.2|0.8|||ANCOVA||The difference was calculated as atropine plus plano group minus atropine group|"The primary analysis was a treatment group comparison of logMAR visual acuity scores in the amblyopic eye obtained 18 weeks after randomization, adjusted for baseline acuity scores in an analysis of covariance (ANCOVA) model.~The primary analysis included only patients with visual acuity of 20/40 to 20/100; sample size was based upon a two-sided alpha of 0.05, with 90% power to detect a difference if the true difference in change from baseline between groups was 0.075 logMAR at 18 weeks."||0.8|-0.2|0.21
74026474|NCT00315302|147606332|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 20/25 or better at 18wks in atropine group = proportion 20/25 or better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 20/25 or better at 18wks in atropine group NOT equal to proportion 20/25 or better at 18wks in atropine plus plano group"||||.03
74026475|NCT00315302|147606333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|3.1|||TWO_SIDED|95.0|3.2|5.8||||||95% confidence interval calculated within treatment group on the amount of change from baseline||5.8|3.2|
74085288|NCT01142908|147724295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.93|TWO_SIDED|95.0|-2.8|3.1|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||3.1|-2.8|0.93
74026476|NCT00315302|147606333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|3.7|||TWO_SIDED|95.0|3.7|6.4||||||95% confidence interval calculated within treatment group on the amount of change from baseline||6.4|3.7|
74026477|NCT00315302|147606334|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 3 or more lines better at 18wks in atropine group = proportion 3 or more lines better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 3 or more lines better at 18wks in atropine group NOT equal to proportion 3 or more lines better at 18wks in atropine plus plano group"||||0.39
74026478|NCT00315302|147606335|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||All patients without respect to cause of amblyopia.||||0.39
74026479|NCT00315302|147606336|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||Among anisometropic patients only||||0.90
74026480|NCT00315302|147606338|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||"Null hypothesis: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups;~Alternate: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups"||||0.003
74026481|NCT00440401|147606355|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals||||||<0.0001
74088501|NCT03923699|147730407|SUPERIORITY||Risk Ratio (RR)|0.98||||0.42|TWO_SIDED|95.0|0.92|1.05||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.05|0.92|0.42
73909671|NCT02713204|147349337|SUPERIORITY||Least square mean difference|-0.89||||0.3091|TWO_SIDED|95.0|-2.61|0.83||Threshold for significance at 0.05 level.|ANCOVA|||||0.83|-2.61|0.3091
73909672|NCT02713204|147349337|SUPERIORITY||Least square mean difference|-0.6||||0.4898|TWO_SIDED|95.0|-2.29|1.1||Threshold for significance at 0.05 level.|ANCOVA|||||1.10|-2.29|0.4898
73909673|NCT02713204|147349337|SUPERIORITY||Least square mean difference|-0.8||||0.3504|TWO_SIDED|95.0|-2.5|0.89||Threshold for significance at 0.05 level.|ANCOVA|||||0.89|-2.50|0.3504
73909674|NCT02713204|147349337|SUPERIORITY||Least square mean difference|-0.98||||0.2632|TWO_SIDED|95.0|-2.7|0.74||Threshold for significance at 0.05 level.|ANCOVA|||||0.74|-2.70|0.2632
73964810|NCT01998984|147465343|SUPERIORITY||Relative risk|3.51||||0.051|TWO_SIDED|95.0|1.0|12.41||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared subject in the vehicle group.~Type I error not controlled."||12.41|1.00|0.051
73964811|NCT01998984|147465343|SUPERIORITY||Relative risk|0.47||||0.25|TWO_SIDED|95.0|0.13|1.68||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Mantel Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Type I error not controlled. Mantel-Haenszel estimators were used."||1.68|0.13|0.25
73964812|NCT01998984|147465344|SUPERIORITY||Ratio of adjusted mean|0.4|||<|0.001|TWO_SIDED|95.0|0.32|0.51||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||0.51|0.32|<0.001
73964813|NCT01998984|147465344|SUPERIORITY||Ratio of adjusted mean|0.36|||<|0.001|TWO_SIDED|95.0|0.29|0.45||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||0.45|0.29|<0.001
73964814|NCT01998984|147465344|SUPERIORITY||Ratio of adjusted mean|0.89||||0.36|TWO_SIDED|95.0|0.7|1.14||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||1.14|0.70|0.36
74026482|NCT00440401|147606356|SUPERIORITY_OR_OTHER||||||<|0.0006||95.0|||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals||||||<0.0006
73909675|NCT02713204|147349337|SUPERIORITY||Least square mean difference|0.21||||0.8056|TWO_SIDED|95.0|-1.46|1.88||Threshold for significance at 0.05 level.|ANCOVA|||||1.88|-1.46|0.8056
73909676|NCT02713204|147349338|SUPERIORITY||Least square mean difference|0.57||||0.5065|TWO_SIDED|95.0|-1.11|2.25||Threshold for significance at 0.05 level.|ANCOVA|||||2.25|-1.11|0.5065
73909677|NCT02713204|147349338|SUPERIORITY||Least square mean difference|-0.22||||0.7418|TWO_SIDED|95.0|-1.55|1.1||Threshold for significance at 0.05 level.|ANCOVA|||||1.10|-1.55|0.7418
74026483|NCT00091793|147606357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|6.2|7.8|||ANCOVA|||||7.8|6.2|<0.0001
74026484|NCT02912364|147606388|OTHER||Mean Difference (Final Values)|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.34|||t-test, 2 sided|degrees of freedom = 22||||.34|.13|< .001
74026485|NCT02912364|147606389|OTHER||Mean Difference (Final Values)|0.54|||<|0.001|TWO_SIDED|95.0|0.3|0.79|||t-test, 2 sided|Degrees of freedom = 22.||||.79|.30|< .001
73909678|NCT02713204|147349339|SUPERIORITY||Least square mean difference|-0.19||||0.8383|TWO_SIDED|95.0|-1.99|1.62||Threshold for significance at 0.05 level.|ANCOVA|||||1.62|-1.99|0.8383
73909679|NCT02713204|147349339|SUPERIORITY||Least square mean difference|-0.1||||0.918|TWO_SIDED|95.0|-1.91|1.72||Threshold for significance at 0.05 level.|ANCOVA|||||1.72|-1.91|0.9180
73909680|NCT02713204|147349339|SUPERIORITY||Least square mean difference|-1.41||||0.1238|TWO_SIDED|95.0|-3.2|0.39||Threshold for significance at 0.05 level.|ANCOVA|||||0.39|-3.20|0.1238
73909681|NCT02713204|147349339|SUPERIORITY||Least square mean difference|-0.97||||0.2819|TWO_SIDED|95.0|-2.73|0.8||Threshold for significance at 0.05 level.|ANCOVA|||||0.80|-2.73|0.2819
73909682|NCT02713204|147349339|SUPERIORITY||Least square mean difference|-1.02||||0.2581|TWO_SIDED|95.0|-2.78|0.75||Threshold for significance at 0.05 level.|ANCOVA|||||0.75|-2.78|0.2581
73909683|NCT02713204|147349339|SUPERIORITY||Least square mean difference|-0.87||||0.339|TWO_SIDED|95.0|-2.66|0.92||Threshold for significance at 0.05 level.|ANCOVA|||||0.92|-2.66|0.3390
73909684|NCT02713204|147349339|SUPERIORITY||Least square mean difference|0.05||||0.9558|TWO_SIDED|95.0|-1.69|1.79||Threshold for significance at 0.05 level.|ANCOVA|||||1.79|-1.69|0.9558
74026486|NCT04800315|147606396|SUPERIORITY||Mean Difference (Final Values)|-21.76||||0.003|TWO_SIDED|95.0|-35.81|-7.7|||ANCOVA|||||-7.70|-35.81|0.003
74026487|NCT04800315|147606396|SUPERIORITY||Mean Difference (Final Values)|-13.38||||0.057|TWO_SIDED|95.0|-27.19|0.43|||ANCOVA|||||0.43|-27.19|0.057
74026488|NCT04800315|147606396|SUPERIORITY||Mean Difference (Final Values)|-16.28||||0.029|TWO_SIDED|95.0|-30.88|-1.68|||ANCOVA|||||-1.68|-30.88|0.029
74026489|NCT04800315|147606397|OTHER|Risk Difference|Risk Difference VS Placebo|24.0||||0.004|TWO_SIDED|95.0|8.8|39.2|||Cochran-Mantel-Haenszel|||||39.2|8.8|0.004
74026490|NCT04800315|147606397|OTHER|Risk Difference|Risk Difference VS Placebo|15.3||||0.061|TWO_SIDED|95.0|0.8|29.8|||Cochran-Mantel-Haenszel|||||29.8|0.8|0.061
74026491|NCT04800315|147606397|OTHER|Risk Difference|Risk Difference VS Placebo|28.9|||<|0.001|TWO_SIDED|95.0|13.6|44.2|||Cochran-Mantel-Haenszel|||||44.2|13.6|<0.001
73857849|NCT04243577|147260809|EQUIVALENCE|Margins for this test were based on the absolute value of the effect size (Cohen's d) being smaller than 0.5.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|Bootstrapping CIs|In this 2nd iteration testing, we are accounting for variance uncertainty, and thus bootstrapping a Confidence Interval for Cohen's d.||For Iteration 2 testing again, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
73857850|NCT04243577|147260810|NON_INFERIORITY|Margin for this test was calculated as minus half a standard deviation using preliminary data acquired with the conventional electrodes, which were considered as the current gold standard and was -.99.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|t-test, 1 sided|||For Iteration 1 testing, we hypothesized that Signal to Noise Ratio (SNR) obtained using the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
73857851|NCT04243577|147260810|NON_INFERIORITY|Margin for this test was based on the effect size (Cohen's d) being larger than -0.5.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|Bootstrapping CIs|In this 2nd iteration testing, we are accounting for variance uncertainty, and thus bootstrapping a one-sided confidence bound for Cohen's d.||For Iteration 2 testing, we again hypothesized that Signal to Noise Ratio (SNR) obtained using the newer version of the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
73857852|NCT04243577|147260811|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|Paired t-test||For Iteration 1 testing, we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.||||<0.05
73857853|NCT04243577|147260811|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|Paired t-test||For Iteration 2 testing, again we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.||||<0.05
73857854|NCT01679600|147260813|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||F1-LD-F1 model by Brunner and Langer|||||||0.53
73857855|NCT00385944|147260853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.91|||<|0.001|TWO_SIDED|95.0|-17.02|-8.81|||Mixed Models Analysis|||||-8.81|-17.02|<0.001
73857856|NCT00385944|147260854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.81|||<|0.001|TWO_SIDED|95.0|-10.96|-4.65|||Mixed Models Analysis|||||-4.65|-10.96|<0.001
73857857|NCT00385944|147260855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.98|||<|0.001|TWO_SIDED|95.0|-17.06|-6.9|||Mixed Models Analysis|||||-6.90|-17.06|<0.001
73857858|NCT00385944|147260856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.3||||0.001|TWO_SIDED|95.0|-6.84|-1.76|||Mixed Models Analysis|||||-1.76|-6.84|0.001
73857859|NCT00385944|147260857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.16|||<|0.001|TWO_SIDED|95.0|7.05|23.26|||Mixed Models Analysis|||||23.26|7.05|<0.001
73857860|NCT00385944|147260858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.69||||0.001|TWO_SIDED|95.0|5.56|19.81|||Mixed Models Analysis|||||19.81|5.56|0.001
73857861|NCT00385944|147260859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.26||||0.015|TWO_SIDED|95.0|2.17|18.34|||Mixed Models Analysis|||||18.34|2.17|0.015
73857862|NCT00385944|147260860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.85||||0.123|TWO_SIDED|95.0|-1.13|8.84|||Mixed Models Analysis|||||8.84|-1.13|0.123
73857863|NCT00385944|147260861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.83|||<|0.001|TWO_SIDED|95.0|-23.05|-10.62|||Mixed Models Analysis|||||-10.62|-23.05|<0.001
73857864|NCT00385944|147260862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.44|||<|0.001|TWO_SIDED|95.0|-70.87|-38.01|||Mixed Models Analysis|||||-38.01|-70.87|<0.001
73857865|NCT00385944|147260864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.5|||<|0.001||95.0|||||two-sided paired t-test|||||||<.001
73857866|NCT00385944|147260865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.011||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately||||0.011
73857867|NCT00385944|147260865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.847||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately||||0.847
73857868|NCT00385944|147260866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.24||||0.008|TWO_SIDED|95.0|-15.99|-2.49|||t-test, 2 sided|||||-2.49|-15.99|0.008
73857869|NCT00385944|147260867|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.52|||<|0.001|TWO_SIDED|95.0|9.22|25.83|||t-test, 2 sided|||||25.83|9.22|<0.001
73857870|NCT01155466|147260871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.87|TWO_SIDED|95.0|-0.62|0.53|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated mean change from baseline in mean off time for preladenant 10 mg - placebo."|||0.53|-0.62|0.8700
73857871|NCT01155466|147260873|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.6||||0.899|TWO_SIDED|95.0|-7.3|1.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 2 mg - placebo|||1.6|-7.3|0.899
74026492|NCT04800315|147606398|OTHER|Risk Difference|Difference VS Placebo|23.7||||0.018|TWO_SIDED|95.0|6.2|41.2|||Cochran-Mantel-Haenszel|||||41.2|6.2|0.018
74026493|NCT04800315|147606398|OTHER|Risk Difference|Difference VS Placebo|21.8||||0.033|TWO_SIDED|95.0|4.3|39.3|||Cochran-Mantel-Haenszel|||||39.3|4.3|0.033
74026494|NCT04800315|147606398|OTHER|Risk Difference|Difference VS Placebo|26.7||||0.006|TWO_SIDED|95.0|9.3|44.0|||Cochran-Mantel-Haenszel|||||44.0|9.3|0.006
74026495|NCT04800315|147606399|OTHER|Risk Difference|Risk Difference|18.1|||||TWO_SIDED|95.0|2.3|33.9|||Cochran-Mantel-Haenszel|||||33.9|2.3|
74026496|NCT04800315|147606399|OTHER|Risk Difference|Risk Difference|10.5|||||TWO_SIDED|95.0|-4.6|25.7|||Cochran-Mantel-Haenszel|||||25.7|-4.6|
74026497|NCT04800315|147606399|SUPERIORITY||Risk Difference|15.9|||||TWO_SIDED|95.0|0.4|31.4|||Cochran-Mantel-Haenszel|||||31.4|0.4|
74026498|NCT04800315|147606400|SUPERIORITY||Mean Difference (Final Values)|-28.16|||||TWO_SIDED|95.0|-41.89|-14.44|||ANCOVA|||||-14.44|-41.89|
74026499|NCT04800315|147606400|SUPERIORITY||Mean Difference (Final Values)|-14.36|||||TWO_SIDED|95.0|-27.26|-1.46|||ANCOVA|||||-1.46|-27.26|
73964815|NCT01998984|147465345|SUPERIORITY||Relative risk|32.26|||<|0.001|TWO_SIDED|95.0|4.39|236.8||P value adjusted for analysis site.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||236.8|4.39|<0.001
73964816|NCT01998984|147465345|SUPERIORITY||Relative risk|25.2||||0.002|TWO_SIDED|95.0|3.39|187.4||Adjusted for analysis site. Relative risk of partial clearance relative to vehicle group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||187.4|3.39|0.002
73857872|NCT01155466|147260873|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.9||||0.815|TWO_SIDED|95.0|-6.8|2.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 5 mg - placebo|||2.6|-6.8|0.815
73857873|NCT01155466|147260873|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.4||||0.295|TWO_SIDED|95.0|-3.9|6.9|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 10 mg - placebo|||6.9|-3.9|0.295
73857874|NCT01155466|147260876|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.629|TWO_SIDED|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 2 mg - placebo|||3.7|-5.1|0.629
73857875|NCT01155466|147260876|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.625|TWO_SIDED|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 5 mg - placebo|||3.7|-5.1|0.625
73857876|NCT01155466|147260876|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.6||||0.948|TWO_SIDED|95.0|-6.8|0.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 10 mg - placebo|||0.7|-6.8|0.948
73857877|NCT01155466|147260877|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1||||0.7044|TWO_SIDED|95.0|-0.61|0.9|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 2 mg - placebo|||0.90|-0.61|0.7044
73857878|NCT01155466|147260877|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.4||||0.3439|TWO_SIDED|95.0|-0.4|1.14|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 5 mg - placebo|||1.14|-0.4|0.3439
73857879|NCT01155466|147260877|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3||||0.3941|TWO_SIDED|95.0|-0.43|1.08|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 10 mg - placebo|||1.08|-0.43|0.3941
73857880|NCT01155466|147260878|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.994||||0.983|TWO_SIDED|95.0|0.597|1.657|||Mixed Models Analysis|Odds ratio was calculated for all randomized and treated participants with at least 1 post treatment value.|"Confidence intervals and P-values were based on a generalized linear mixed model with baseline average off time as a covariate and treatment-by-time interaction as fixed effect and participant as random effect."|||1.657|0.597|0.983
73857881|NCT01155466|147260879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.6405|TWO_SIDED|95.0|-0.49|0.8|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated change from baseline in on time without troublesome dyskinesias for preladenant 10 mg - placebo."|||0.80|-0.49|0.6405
73857882|NCT00834990|147260896|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.41||||||90.0|97.13|110.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110.08|97.13|
73857883|NCT00834990|147260897|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|101.68||||||90.0|96.79|106.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.83|96.79|
73857884|NCT00834990|147260898|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.17||||||90.0|98.5|108.05|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.05|98.5|
73964817|NCT01998984|147465345|SUPERIORITY||Relative risk|1.2||||0.28|TWO_SIDED|95.0|0.86|1.65||Adjusted for analysis site. Relative risk of partial clearance relative to 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||1.65|0.86|0.28
74026500|NCT04800315|147606400|SUPERIORITY||Mean Difference (Final Values)|-19.07|||||TWO_SIDED|95.0|-33.53|-4.62|||ANCOVA|||||-4.62|-33.53|
74026501|NCT04800315|147606401|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-22.5|||||TWO_SIDED|95.0|-41.46|-3.54|||ANCOVA|||||-3.54|-41.46|
73857885|NCT00791479|147260905|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
73857886|NCT00791479|147260905|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
73857887|NCT00791479|147260905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.069||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.069
74026502|NCT04800315|147606401|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-13.17|||||TWO_SIDED|95.0|-30.67|4.33|||ANCOVA|||||4.33|-30.67|
73909685|NCT04402060|147349348|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.82|TWO_SIDED|90.0|0.63|1.51|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% confidence interval (CI) was based on the Wald method.||1.51|0.63|0.82
73909686|NCT04402060|147349349|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.36|TWO_SIDED|90.0|0.77|3.4|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||3.40|0.77|0.36
74026503|NCT04800315|147606401|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-16.32|||||TWO_SIDED|95.0|-36.4|3.75|||ANCOVA|||||3.75|-36.40|
73857888|NCT00791479|147260905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
73857889|NCT00791479|147260905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
73857890|NCT00791479|147260905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
73857891|NCT00791479|147260906|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
73857892|NCT00791479|147260906|SUPERIORITY_OR_OTHER|||||||0.023||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.023
73857893|NCT00791479|147260906|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
73857894|NCT00791479|147260906|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
73857895|NCT00791479|147260907|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
73857896|NCT00791479|147260907|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
73857897|NCT00791479|147260907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.81||||0.456||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.456
73857898|NCT00791479|147260907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.53|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
73857899|NCT00791479|147260907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.96|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
73857900|NCT00791479|147260907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.71|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
73857901|NCT00791479|147260908|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels \<7.0%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.||||||<0.001
73857902|NCT00791479|147260908|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels ≤6.5%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.||||||<0.001
73857903|NCT00791479|147260909|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
73857904|NCT00791479|147260909|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
73857905|NCT00791479|147260909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.65||||0.378||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.378
73857906|NCT00791479|147260909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.09|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
73857907|NCT00791479|147260909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.34|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
73930973|NCT01147653|147391716|SUPERIORITY|||||||0.396|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Time change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.396
73930974|NCT01147653|147391716|SUPERIORITY|||||||0.381|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Physical Abilities change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.381
73930975|NCT01147653|147391716|SUPERIORITY|||||||0.869|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Temperament and Moods change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.869
74026504|NCT04800315|147606402|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|18.5||||0.042|TWO_SIDED|95.0|2.7|34.3|||Cochran-Mantel-Haenszel|||||34.3|2.7|0.042
74026505|NCT04800315|147606402|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|19.9||||0.029|TWO_SIDED|95.0|4.1|35.7|||Cochran-Mantel-Haenszel|||||35.7|4.1|0.029
74026506|NCT04800315|147606402|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|18.0||||0.052|TWO_SIDED|95.0|2.3|33.6|||Cochran-Mantel-Haenszel|||||33.6|2.3|0.052
74085289|NCT01142908|147724296|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4||||0.34|TWO_SIDED|95.0|-1.5|4.3|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||4.3|-1.5|0.34
74085290|NCT01142908|147724298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.91|TWO_SIDED|95.0|-2.0|1.8|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||1.8|-2.0|0.91
74085291|NCT01142908|147724299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4||||0.7|TWO_SIDED|95.0|-1.5|2.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||2.2|-1.5|0.70
74085292|NCT01142908|147724300|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.8||||0.1|TWO_SIDED|95.0|-3.9|0.3|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.3|-3.9|0.1
74085293|NCT01142908|147724301|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.3||||0.74|TWO_SIDED|95.0|-2.4|1.7|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months||1.7|-2.4|0.74
74085294|NCT01142908|147724303|SUPERIORITY_OR_OTHER_LEGACY||logit-difference (Net)|-0.03||||0.87|TWO_SIDED|95.0|-0.4|0.3|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.3|-0.4|0.87
73909687|NCT04402060|147349351|SUPERIORITY||Hazard Ratio (HR)|0.09||||0.03|TWO_SIDED|90.0|0.01|0.51|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||0.51|0.01|0.03
74085295|NCT01142908|147724304|SUPERIORITY_OR_OTHER_LEGACY||logit-difference (Net)|0.2||||0.36|TWO_SIDED|95.0|-0.2|0.5|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||0.5|-0.2|0.36
74085296|NCT01142908|147724306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.9||||0.08|TWO_SIDED|95.0|-10.3|0.6|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.6|-10.3|0.08
73909688|NCT04402060|147349352|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.93|TWO_SIDED|90.0|0.69|1.72|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||1.72|0.69|0.93
73909689|NCT02256072|147349365|SUPERIORITY_OR_OTHER||Slope|1.25|STANDARD_ERROR_OF_MEAN|0.45||0.0054|TWO_SIDED|95.0|0.37|2.12|||ANCOVA|||H1: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased planning with regard to planning behavior score (measured via the Planning Assessment tool) one (efficacy) month after intervention.||2.12|0.37|0.0054
73909690|NCT02256072|147349366|SUPERIORITY_OR_OTHER||Slope|0.244|STANDARD_ERROR_OF_MEAN|0.123||0.0471|TWO_SIDED|||||P-value controlled for significant baseline covariates (sex, importance of religion, stroke, and self efficacy score) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Secondary analyses will compare baseline variables (current utilization of services, physical function assessment, co-morbidities, social support, health literacy, self-efficacy, and sociodemographics) with outcome (one-at-a-time). Those found to have a significant association with outcome will be included in a linear mixed model, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for outcome.||||0.0471
73930976|NCT01147653|147391717|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||H0: The 12 month Access to Services change score is identically distributed in patients assigned Autologous Cord Blood Reinfusion First and Placebo First.||||0.055
73930977|NCT01147653|147391717|SUPERIORITY|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Emotional Well Being and Self Esteem change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.121
73930978|NCT01147653|147391717|SUPERIORITY|||||||0.647|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Family Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.647
73930979|NCT01147653|147391717|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Functioning change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.170
74085297|NCT01142908|147724307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.8||||0.79|TWO_SIDED|95.0|-6.6|5.0|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||5.0|-6.6|0.79
74085298|NCT01142908|147724309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.02||||0.83|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.2|-0.2|0.83
74085299|NCT01142908|147724310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.54|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||0.2|-0.4|0.54
74085300|NCT01142908|147724312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.29|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.2|-0.6|0.29
74085301|NCT01142908|147724313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.72|TWO_SIDED|95.0|-0.5|0.4|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months||0.4|-0.5|0.72
73857908|NCT00791479|147260909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.67|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
73857909|NCT00791479|147260910|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
73857910|NCT00791479|147260910|SUPERIORITY_OR_OTHER|||||||0.036||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.036
73857911|NCT00791479|147260911|SUPERIORITY_OR_OTHER|||||||0.45||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||0.450
73857912|NCT00791479|147260911|SUPERIORITY_OR_OTHER|||||||0.329||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.329
73857913|NCT00791479|147260919|SUPERIORITY_OR_OTHER|||||||0.969||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||0.969
73857914|NCT00791479|147260919|SUPERIORITY_OR_OTHER|||||||0.009||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.009
73857915|NCT00791479|147260919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.14||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.140
73857916|NCT00791479|147260919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.247||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.247
73930980|NCT01147653|147391717|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Pain and Impact of Disability change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.410
74085302|NCT04291508|147724375|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.65|TWO_SIDED|95.0|-1.6|2.5|||t-test, 2 sided|||||2.5|-1.6|0.65
73857917|NCT00791479|147260919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.975||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.975
73857918|NCT00791479|147260919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||1||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||1.00
73857919|NCT01778049|147260922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.0013||95.0|-0.52|-0.13|||Mixed Model Repeated Measure (MMRM)|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference calculated as lina5 (E10) minus Plc (E10) value.|Superiority of lina5 (E10) vs. Plc (E10): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates \& baseline estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.13|-0.52|0.0013
73857920|NCT01778049|147260922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.66|-0.28|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.28|-0.66|<0.0001
73857921|NCT01778049|147260923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.25||0.0103||95.0|-1.15|-0.16|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E10) minus Plc (E10).|Superiority of lina5 (E10) vs. Plc (E10): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c \& baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.16|-1.15|0.0103
73857922|NCT01778049|147260923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.22||0.0452||95.0|-0.87|-0.01|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c \& baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.01|-0.87|0.0452
73857923|NCT00557310|147260997|SUPERIORITY_OR_OTHER|||||||0.363||95.0|||||Mixed Model Repeated Measurements|||||||0.363
73857924|NCT00557310|147260998|SUPERIORITY_OR_OTHER|||||||0.837||95.0|||||Mixed Model Repeated Measurements|||||||0.837
73857925|NCT00557310|147260999|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measurements|||||||0.816
73857926|NCT00557310|147260999|SUPERIORITY_OR_OTHER|||||||0.934||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.934
73857927|NCT00557310|147261000|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measures|||||||0.324
74085303|NCT04291508|147724375|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.464|TWO_SIDED|95.0|-3.5|7.6|||t-test, 2 sided|||||7.6|-3.5|0.464
74085304|NCT04291508|147724376|SUPERIORITY||Risk Difference (RD)|-4.3||||0.26|TWO_SIDED|95.0|-12.0|3.3|||Chi-squared|||||3.3|-12.0|0.26
74085305|NCT04291508|147724376|SUPERIORITY||Risk Difference (RD)|-13.6||||0.31|TWO_SIDED|95.0|-35.8|8.7|||Fisher Exact|||||8.7|-35.8|0.31
74085306|NCT04291508|147724377|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.35|TWO_SIDED|95.0|-1.0|2.9|||t-test, 2 sided|||||2.9|-1.0|0.35
73909691|NCT02256072|147349367|SUPERIORITY_OR_OTHER||Slope|0.075|STANDARD_ERROR_OF_MEAN|0.094||0.423|TWO_SIDED|||||p-value controlled for significant baseline covariates (confidence in using the internet, self efficacy score, support score, and race/ethnicity.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.|The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, with a total possible range of 5-25. No subscores are calculated.|H2: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased confidence in accessing home services (measured via the Confidence in Accessing Home Services tool) one (efficacy) and three (effect retention) months after intervention.||||0.423
74026507|NCT04800315|147606404|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-23.12|||||TWO_SIDED|95.0|-41.48|-4.76|||ANCOVA|||||-4.76|-41.48|
73857928|NCT00557310|147261000|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measures|||||||0.089
73857929|NCT00557310|147261001|SUPERIORITY_OR_OTHER|||||||0.847||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.||||||0.847
73857930|NCT00557310|147261001|SUPERIORITY_OR_OTHER|||||||0.212||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.212
73857931|NCT00557310|147261002|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 3 months.||||||0.335
73857932|NCT00557310|147261002|SUPERIORITY_OR_OTHER|||||||0.916||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||0.916
73857933|NCT00557310|147261002|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||P-value is for the percent change from baseline at 12 months.|Mixed Model Repeated Measurements|||||||0.610
73930981|NCT01147653|147391717|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Participation and Physical Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.200
73930982|NCT01147653|147391717|SUPERIORITY|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Social wellbeing and acceptance change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.225
73930983|NCT01147653|147391720|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.290
73857934|NCT00557310|147261002|SUPERIORITY_OR_OTHER|||||||0.363||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.||||||0.363
73857935|NCT00557310|147261002|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.837
73930984|NCT01147653|147391723|SUPERIORITY|||||||0.697|||||||t-test, 2 sided|||||||0.697
73930985|NCT01147653|147391724|SUPERIORITY|||||||0.912|||||||t-test, 2 sided|||||||0.912
73930986|NCT01147653|147391725|SUPERIORITY|||||||0.544|||||||t-test, 2 sided|||||||0.544
73857936|NCT00557310|147261003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
73857937|NCT00557310|147261004|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||ANOVA|||||||0.021
73857938|NCT00557310|147261005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
73857939|NCT00557310|147261006|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
73857940|NCT00557310|147261007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||<0.001
73857941|NCT00557310|147261007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||<0.001
73857942|NCT00557310|147261008|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.011
73857943|NCT00557310|147261008|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.049
73857944|NCT00557310|147261009|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.700
73857945|NCT00557310|147261009|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.092
73857946|NCT00557310|147261010|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.013
73857947|NCT00557310|147261010|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.005
73857948|NCT00557310|147261011|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.106
73857949|NCT00557310|147261011|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.436
73857950|NCT00557310|147261012|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements|||||||<0.001
73857951|NCT00557310|147261012|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||<0.001
73857952|NCT00557310|147261012|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||<0.001
73930987|NCT01147653|147391726|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
73930988|NCT01147653|147391727|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
73930989|NCT01147653|147391728|SUPERIORITY|||||||0.176|||||||Wilcoxon (Mann-Whitney)|||||||0.176
73930990|NCT01147653|147391729|SUPERIORITY|||||||0.099|||||||t-test, 2 sided|||||||0.099
73930991|NCT01147653|147391730|SUPERIORITY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
73930992|NCT01147653|147391731|SUPERIORITY|||||||0.478|||||||t-test, 2 sided|||||||0.478
73930993|NCT01147653|147391732|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
73930994|NCT01147653|147391733|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.310
73930995|NCT01147653|147391735|SUPERIORITY|||||||0.233|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of Modified Ashworth Scale scores is the same at 1-year post-infusion with autologous cord blood and placebo.||||0.233
73930996|NCT01147653|147391739|SUPERIORITY|||||||0.762|||||||Wilcoxon (Mann-Whitney)|||||||0.762
73930997|NCT01147653|147391740|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low and High doses of autologous umbilical cord blood.||||0.05
73857953|NCT00557310|147261013|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements|||||||0.012
73857954|NCT00557310|147261013|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||0.012
73857955|NCT00557310|147261013|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.016
73857956|NCT04049266|147261028|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4 ETDRS letters, i.e. the non-inferiority margin (NI) is 4 letters.|Adjusted mean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.01|>|0.9999|TWO_SIDED|95.03|-8.0|-4.0|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, categories for baseline BCVA, BCVA-low luminance VA baseline, geographical location.||||-4|-8|> 0.9999
73857957|NCT01703208|147261036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.77|1.29|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.29|0.77|
73857958|NCT01703208|147261037|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.43|||||TWO_SIDED|95.0|-0.48|-0.37||||||||-0.37|-0.48|
73857959|NCT01703208|147261038|SUPERIORITY_OR_OTHER||Difference in the LS Means vs Placebo|-0.39|||<|0.001|TWO_SIDED|95.0|-0.5|-0.27|||Longitudinal data analysis|Longitudinal data analysis model including terms for treatment, time and the interaction of time by treatment.||||-0.27|-0.50|<0.001
73857960|NCT01703208|147261039|SUPERIORITY_OR_OTHER||Difference in Percent vs. Placebo|-1.1|||||TWO_SIDED|95.0|-7.2|4.9|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||4.9|-7.2|
73909692|NCT02256072|147349368|SUPERIORITY_OR_OTHER||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|||||p-value controlled for significant baseline covariates (sex, income, health literacy, education level, high blood pressure, and kidney disease) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Compared to participants in the attention control group, participants receiving PLAN YOUR LIFESPAN will show increased UHS 1 (efficacy) and 3 (effect retention) months post-intervention. Secondary analyses will compare baseline variables with outcome (one-at-a-time). Those with a significant association with outcome will be included in a LMM for UHS, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for UHS.||||<0.0001
73909693|NCT02572609|147349387|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|113.56|STANDARD_DEVIATION|16.24||0.0082|TWO_SIDED|90.0|106.48|121.1|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).|||121.10|106.48|0.0082
73909694|NCT02572609|147349388|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence in the AUC0-t will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|119.61|STANDARD_DEVIATION|10.65||0.0438|TWO_SIDED|90.0|114.65|124.79|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).|||124.79|114.65|0.0438
73930998|NCT01147653|147391740|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with High doses of autologous umbilical cord blood and Placebo.||||0.15
73930999|NCT01147653|147391740|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low doses of autologous umbilical cord blood and placebo.||||0.21
73931000|NCT01147653|147391741|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of differences between observed and expected GMFM-66 change scores at 1-year post-infusion is the same for patients receiving Low and High doses of autologous umbilical cord blood.||||<0.01
73857961|NCT01703208|147261040|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Placebo|0.3|||||TWO_SIDED|95.0|-1.0|1.7|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||1.7|-1.0|
73857962|NCT01703208|147261042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.66|1.68|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.68|0.66|
73857963|NCT01703208|147261044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.6|1.26|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.26|0.60|
73857964|NCT01703208|147261046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.58|1.52|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.52|0.58|
73857965|NCT01703208|147261048|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.88|1.85|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.85|0.88|
73857966|NCT01703208|147261049|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.3|||||TWO_SIDED|95.0|-0.46|-0.14|||||Longitudinal Data Analysis (LDA) model including terms for treatment, time, and the interaction of time by treatment.|||-0.14|-0.46|
73857967|NCT01703208|147261055|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.1||||0.421|TWO_SIDED|95.0|-10.8|4.5|||Longitudinal constrained data analysis||Based on a LDA model including terms for treatment, time and the interaction of time by treatment.|||4.5|-10.8|0.421
73857968|NCT01703208|147261056|SUPERIORITY_OR_OTHER||Between group rate difference|11.9|||<|0.001|TWO_SIDED|95.0|6.9|16.8||Estimated using standard multiple imputation techniques.|Miettinen & Nurminen method|||||16.8|6.9|<0.001
73857969|NCT01703208|147261058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.35|1.05|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.05|0.35|
73857970|NCT03655301|147261059|OTHER||Least squares mean|0.9405|||||TWO_SIDED|90.0|0.8093|1.0931||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of Cmax||1.0931|0.8093|
73857971|NCT03655301|147261060|OTHER||Least squares mean|1.1205|||||TWO_SIDED|90.0|1.0|1.2555||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC(0-24)||1.2555|1.0000|
73857972|NCT03655301|147261061|OTHER||Least squares mean|1.1147|||||TWO_SIDED|90.0|0.9772|1.2714||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC||1.2714|0.9772|
74026508|NCT04800315|147606404|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-8.28|||||TWO_SIDED|95.0|-25.16|8.59|||ANCOVA|||||8.59|-25.16|
74026509|NCT04800315|147606404|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-10.87|||||TWO_SIDED|95.0|-29.39|7.66|||ANCOVA|||||7.66|-29.39|
74026510|NCT03851510|147606425|OTHER|95% confidence of prevalence measure.|prevalence|46.3|||||TWO_SIDED|95.0|32.6|60.4||||||All participants that were consented, eligible, and completed the Vector EFL screening (supine).||60.4|32.6|
74026511|NCT00144300|147606447|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||||95.0|0.71|1.6||||||||1.60|0.71|
74026512|NCT01933672|147606470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.24|||||TWO_SIDED|80.0|-36.35|-26.12||||||Change from baseline||-26.12|-36.35|
74026513|NCT01933672|147606470|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-31.33|||||TWO_SIDED|80.0|-37.29|-25.37||||||Change from baseline||-25.37|-37.29|
73857973|NCT00367744|147261070|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment groups were compared for change in limb fat using a two-sided signed rank test||The primary outcome measure was the change in limb fat at 48 weeks between the rosiglitazone and placebo group.||||0.02
73857974|NCT04270682|147261085|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed urine 23S-pentol in the adult cohort.|Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|0.332|<|0.0001|TWO_SIDED|95.0|-3.794|-2.331|||paired t-test|||||-2.331|-3.794|<0.0001
73857975|NCT04270682|147261086|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed plasma cholestanol in the adult cohort.|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.241||0.0083|TWO_SIDED|95.0|-1.64|-0.399|||paired t-test|||||-0.399|-1.640|0.0083
73857976|NCT04270682|147261087|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed Plasma 7αC4 in the adult cohort.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.224|<|0.0001|TWO_SIDED|95.0|-4.193|-3.207|||paired t-test|||||-3.207|-4.193|<0.0001
73857977|NCT04270682|147261088|EQUIVALENCE|Exact 2 sided p-value for observing contingency tables of rescue data with equal or more extreme values is calculated using Prescott's method. Rejection of the null hypothesis for no association suggests there is a difference between two treatments.|proportion|0.077||||0.0006|TWO_SIDED|95.0|0.0|0.36|||Prescott's|||||0.36|0.00|0.0006
73857978|NCT04270682|147261088|EQUIVALENCE|Exact 2 sided p-value for observing contingency tables of rescue data with equal or more extreme values is calculated using Prescott's method. Rejection of the null hypothesis for no association suggests there is a difference between two treatments.|proportion|0.62||||0.0006|TWO_SIDED|95.0|0.32|0.86|||Prescott's|||||0.86|0.32|0.0006
73857979|NCT03569748|147261100|NON_INFERIORITY|Margin=0.04|Proportion Difference|0.1342||||0.0051|TWO_SIDED|95.0|0.0014|0.2671|||Chi-squared, Corrected|||H0: P1-P2 ≤ -Margin||0.2671|0.0014|0.0051
73857980|NCT03569748|147261101|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||||||0.0003
73857981|NCT03569748|147261102|SUPERIORITY||Percentage Difference|14.2||||0.0003|TWO_SIDED||||||Chi-squared, Corrected|||||||0.0003
73857982|NCT03955250|147261154|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73857983|NCT03955250|147261155|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|time||||||<0.05
73857984|NCT03955250|147261155|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
73857985|NCT03955250|147261156|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|time||||||>0.05
73857986|NCT03955250|147261156|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
73857987|NCT03955250|147261157|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|time||||||<0.05
73857988|NCT03955250|147261157|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
73857989|NCT00433160|147261168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement Point. No adjustments for multiplicity was performed.|t-test, 2 sided|||Null hypothesis: there is no difference in the percent change in bone mineral density at lumbar spine (L2-L4) after 52-week treatment between the two treatment groups.||||<0.001
73857990|NCT00433160|147261172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 4-week treatment between the two treatment groups.||||<0.001
73857991|NCT00433160|147261172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 12-week treatment between the two treatment groups.||||<0.001
73857992|NCT00433160|147261172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 24-week treatment between the two treatment groups.||||<0.001
73857993|NCT00433160|147261172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 52-week treatment between the two treatment groups.||||<0.001
73857994|NCT00433160|147261172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP from baseline to the last measurement point between the two treatment groups.||||<0.001
73857995|NCT00433160|147261173|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 4-week treatment between the two treatment groups.||||<0.001
73857996|NCT00433160|147261173|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 12-week treatment between the two treatment groups.||||<0.001
73909695|NCT02155881|147349415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.9716|TWO_SIDED|95.0|-0.98|1.01|||ANCOVA|||An analysis of covariance (ANCOVA) model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||1.01|-0.98|0.9716
73909696|NCT02155881|147349416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.8713|TWO_SIDED|95.0|-0.87|1.02|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||1.02|-0.87|0.8713
73909697|NCT02155881|147349417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.7789|TWO_SIDED|95.0|-0.61|0.81|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.81|-0.61|0.7789
73909698|NCT02155881|147349418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.663|TWO_SIDED|95.0|-0.55|0.86|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.86|-0.55|0.6630
73909699|NCT02155881|147349419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.5593|TWO_SIDED|95.0|-0.35|0.19|||ANCOVA|||Nasal congestion: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.19|-0.35|0.5593
73909700|NCT02155881|147349419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.7085|TWO_SIDED|95.0|-0.22|0.33|||ANCOVA|||Runny nose: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.33|-0.22|0.7085
73909701|NCT02155881|147349419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.7309|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|||Itching: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.31|-0.22|0.7309
73909702|NCT02155881|147349419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.9584|TWO_SIDED|95.0|-0.29|0.3|||ANCOVA|||Sneezing: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.30|-0.29|0.9584
73909703|NCT02155881|147349420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.2266|TWO_SIDED|95.0|-0.11|0.46|||ANCOVA|||Itching/Burning Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.46|-0.11|0.2266
73909704|NCT02155881|147349420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.4888|TWO_SIDED|95.0|-0.35|0.17|||ANCOVA|||Redness: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.17|-0.35|0.4888
73909705|NCT02155881|147349420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.8316|TWO_SIDED|95.0|-0.22|0.27|||ANCOVA|||Tearing/Watering Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.27|-0.22|0.8316
73909706|NCT02155881|147349421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.2968|TWO_SIDED|95.0|-0.8|0.25|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.25|-0.80|0.2968
73909707|NCT02155881|147349422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.3533|TWO_SIDED|95.0|-0.85|0.31|||ANCOVA|||Activities: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.31|-0.85|0.3533
73909708|NCT02155881|147349422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.3712|TWO_SIDED|95.0|-0.84|0.32|||ANCOVA|||Sleep: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.32|-0.84|0.3712
73909709|NCT02155881|147349422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.4098|TWO_SIDED|95.0|-0.69|0.29|||ANCOVA|||Non-nose/Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.29|-0.69|0.4098
73909710|NCT02155881|147349422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.2683|TWO_SIDED|95.0|-1.0|0.28|||ANCOVA|||Practical Problems: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.28|-1.00|0.2683
73909711|NCT02155881|147349422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4643|TWO_SIDED|95.0|-0.82|0.38|||ANCOVA|||Nasal Symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.38|-0.82|0.4643
73909712|NCT02155881|147349422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.4502|TWO_SIDED|95.0|-0.74|0.33|||ANCOVA|||Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.33|-0.74|0.4502
73909713|NCT02155881|147349422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.177|TWO_SIDED|95.0|-0.95|0.18|||ANCOVA|||Emotional: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.18|-0.95|0.1770
73909714|NCT02298023|147349467|OTHER|||||||0.35|||||||Kruskal-Wallis|||Null hypothesis: There is no difference between the three groups. Statistical power: 0.80||||0.35
73909715|NCT02298023|147349468|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.662|||||||Mixed Models Analysis|||||||0.662
73857997|NCT00433160|147261173|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 24-week treatment between the two treatment groups.||||<0.001
73857998|NCT00433160|147261173|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wicoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 52-week treatment between the two treatment groups.||||0.060
73857999|NCT00433160|147261173|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP from baseline to the last measurement point between the two treatment groups.||||0.130
73858000|NCT00433160|147261174|SUPERIORITY_OR_OTHER|||||||0.976||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 4-week treatment between the two treatment groups.||||0.976
73858001|NCT00433160|147261174|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 12-week treatment between the two treatment groups.||||<0.001
73858002|NCT00433160|147261174|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 24-week treatment between the two treatment groups.||||<0.001
73858003|NCT00433160|147261174|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 52-week treatment between the two treatment groups.||||<0.001
73858004|NCT00433160|147261174|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX from baseline to the last measurement point between the two treatment groups.||||<0.001
73858005|NCT02793817|147261193|SUPERIORITY||Difference in percentage of responders|8.3||||0.0105|TWO_SIDED|95.0|2.0|14.7||To account for multiplicity, a step-down testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared tests (unadjusted) wherein the a priori significance level was 0.05.||14.7|2.0|0.0105
73858006|NCT02793817|147261194|SUPERIORITY||Difference in percentage of responders|20.0|||<|0.0001|TWO_SIDED|95.0|11.6|28.4||To account for multiplicity, a step-down closed testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared test (unadjusted), wherein a priori significance level was 0.05||28.4|11.6|<0.0001
73858007|NCT02793817|147261195|SUPERIORITY||Difference in percentage of responders|17.1|||<|0.0001|TWO_SIDED|95.0|9.1|25.0||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|||25.0|9.1|<0.0001
73858008|NCT02793817|147261196|SUPERIORITY||Difference in percentage of responders|19.0|||<|0.0001|TWO_SIDED|95.0|11.0|26.9||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|||26.9|11.0|<0.0001
73858009|NCT02793817|147261197|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0078|TWO_SIDED|95.0|-0.31|-0.05|||Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for change from BL.|P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.||-0.05|-0.31|0.0078
73858010|NCT02793817|147261198|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.0005|TWO_SIDED|95.0|-0.38|-0.11||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without any adjustment for covariates|Estimated Value is the between-group difference in change from BL|||-0.11|-0.38|0.0005
73858011|NCT02793817|147261199|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.0169|TWO_SIDED|95.0|-0.28|-0.03||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without adjustments for any covariates.|Estimated Value is the between-group difference for change from BL|||-0.03|-0.28|0.0169
73858012|NCT02226198|147261200|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.3||||0.005|TWO_SIDED|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta||-9.1|-33.5|0.005
73909716|NCT02298023|147349469|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.882|||||||Mixed Models Analysis|||||||0.882
73858013|NCT02226198|147261201|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.3||||0.005|TWO_SIDED|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta||-9.1|-33.5|0.005
73858014|NCT02226198|147261202|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.1||||0.003|TWO_SIDED|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-9.1|-29.7|0.003
73858015|NCT02226198|147261203|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.1||||0.003|TWO_SIDED|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-9.1|-29.7|0.003
74085307|NCT04291508|147724377|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.45|TWO_SIDED|95.0|-3.4|7.6|||t-test, 2 sided|||||7.6|-3.4|0.45
73858016|NCT02226198|147261204|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.9||||0.003|TWO_SIDED|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.3|-33.7|0.003
73858017|NCT02226198|147261205|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.9||||0.003|TWO_SIDED|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.3|-33.7|0.003
73858018|NCT02226198|147261206|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-17.1||||0.024|TWO_SIDED|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-2.9|-29.2|0.024
73858019|NCT02226198|147261207|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-17.1||||0.024|TWO_SIDED|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-2.9|-29.2|0.024
73858020|NCT02226198|147261208|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|7.4||||0.314|TWO_SIDED|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||24.5|-7.4|0.314
73858021|NCT02226198|147261209|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|7.4||||0.314|TWO_SIDED|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||24.5|-7.4|0.314
73858022|NCT02226198|147261210|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-26.3||||0.08|TWO_SIDED|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||6.0|-48.7|0.080
73858023|NCT02226198|147261211|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-26.3||||0.08|TWO_SIDED|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||6.0|-48.7|0.080
73858024|NCT02226198|147261222|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-30.4||||0.004|TWO_SIDED|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-13.3|-44.2|0.004
73858025|NCT02226198|147261223|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-30.4||||0.004|TWO_SIDED|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-13.3|-44.2|0.004
73858026|NCT02226198|147261224|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-27.6||||0.006|TWO_SIDED|95.0|-41.2|-11.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-11.0|-41.2|0.006
73858027|NCT02226198|147261225|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-25.6||||0.005|TWO_SIDED|95.0|-38.1|-10.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.5|-38.1|0.005
73858028|NCT02226198|147261226|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-28.2||||0.005|TWO_SIDED|95.0|-41.7|-11.4||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-11.4|-41.7|0.005
73858029|NCT02226198|147261227|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.4||||0.013|TWO_SIDED|95.0|-32.8|-5.6||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-5.6|-32.8|0.013
73858030|NCT03895632|147261232|OTHER|A linear mixed-effects model was fit to assess the association between α (the slope of the Power Spectral Density (PSD) plot) and signal segment.|||||<|0.0001||||||p-value obtained form the Wald statistics of the linear mixed-effects model. The threshold for statistical signifiance was p=0.01.|Linear mixed-effects model|||The null hypothesis was that α (the slope of the Power Spectral Density (PSD) plot) is not related to signal segment (off-, approaching- and on-target).||||<0.0001
73858031|NCT01288612|147261244|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Chi-squared|||||||0.25
73909717|NCT02298023|147349470|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.835|||||||Mixed Models Analysis|||||||0.835
73858032|NCT01288612|147261244|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Chi-squared|||||||0.42
73858033|NCT01288612|147261244|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Chi-squared|||||||0.27
73858034|NCT01288612|147261244|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Chi-squared|||||||0.82
73858035|NCT01288612|147261245|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Kruskal-Wallis|||||||0.06
73858036|NCT01288612|147261246|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Fisher Exact|||||||0.08
73858037|NCT01288612|147261247|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||||||0.001
73858038|NCT01288612|147261248|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
73858039|NCT01288612|147261249|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
73909718|NCT02298023|147349471|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.977|||||||Mixed Models Analysis|||||||0.977
73858040|NCT01288612|147261250|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for pain scale||||<0.001
73858041|NCT01288612|147261250|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for choking scale||||<0.001
73858042|NCT01288612|147261250|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for gagging scale||||<0.001
73858043|NCT01288612|147261250|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for anxiety scale||||<0.001
73858044|NCT01288612|147261250|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between arms for overall tolerance scale||||<0.001
73858045|NCT01288612|147261251|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||||||0.001
74085308|NCT04291508|147724378|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.83|TWO_SIDED|95.0|-1.9|1.5|||t-test, 2 sided|||||1.5|-1.9|0.83
74085309|NCT04291508|147724378|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.1|TWO_SIDED|95.0|-0.8|8.9|||t-test, 2 sided|||||8.9|-0.8|0.10
74085310|NCT04291508|147724379|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.55|TWO_SIDED|95.0|-1.2|2.4|||t-test, 2 sided|||||2.4|-1.2|0.55
74085311|NCT04291508|147724379|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.18|TWO_SIDED|95.0|-1.6|8.7|||t-test, 2 sided|||||8.7|-1.6|0.18
74085312|NCT04291508|147724380|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.21|TWO_SIDED|95.0|-0.8|3.6|||t-test, 2 sided|||||3.6|-0.8|0.21
73858046|NCT05858450|147261278|OTHER||Weighted Hazard Ratio|1.108|||||TWO_SIDED|95.0|1.018|1.205||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an inverse probability of treatment weights (IPTW) was applied. Analysis performed using IPTW method.||1.205|1.018|
73858047|NCT05858450|147261278|OTHER||Weighted Hazard Ratio|0.634|||||TWO_SIDED|95.0|0.606|0.664||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.664|0.606|
73858048|NCT05858450|147261279|OTHER||Weighted Hazard Ratio|1.061|||||TWO_SIDED|95.0|1.016|1.107||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.107|1.016|
73858049|NCT05858450|147261279|OTHER||Weighted Hazard Ratio|0.897|||||TWO_SIDED|95.0|0.875|0.919||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.919|0.875|
73858050|NCT05858450|147261280|OTHER||Weighted Hazard Ratio|1.543|||||TWO_SIDED|95.0|1.133|2.1||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.1|1.133|
73858051|NCT05858450|147261280|OTHER||Weighted Hazard Ratio|1.106|||||TWO_SIDED|95.0|1.014|1.206||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.206|1.014|
73858052|NCT05858450|147261281|OTHER||Weighted Hazard Ratio|1.048|||||TWO_SIDED|95.0|0.903|1.217||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.217|0.903|
73858053|NCT05858450|147261281|OTHER||Weighted Hazard Ratio|0.908|||||TWO_SIDED|95.0|0.846|0.973||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.973|0.846|
73858054|NCT05858450|147261282|OTHER||Weighted Hazard Ratio|1.137|||||TWO_SIDED|95.0|1.068|1.211||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.211|1.068|
73858055|NCT05858450|147261282|OTHER||Weighted Hazard Ratio|1.057|||||TWO_SIDED|95.0|1.007|1.11||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.11|1.007|
73858056|NCT05858450|147261283|OTHER||Weighted Hazard Ratio|0.761|||||TWO_SIDED|95.0|0.718|0.807||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.807|0.718|
73858057|NCT05858450|147261283|OTHER||Weighted Hazard Ratio|0.858|||||TWO_SIDED|95.0|0.811|0.907||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.907|0.811|
73858058|NCT05858450|147261284|OTHER||Weighted Hazard Ratio|1.55|||||TWO_SIDED|95.0|0.88|2.731||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.731|0.88|
73858059|NCT05858450|147261284|OTHER||Weighted Hazard Ratio|1.035|||||TWO_SIDED|95.0|0.865|1.238||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.238|0.865|
73858060|NCT05858450|147261285|OTHER||Weighted Hazard Ratio|0.921|||||TWO_SIDED|95.0|0.687|1.233||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.233|0.687|
73858061|NCT05858450|147261285|OTHER||Weighted Hazard Ratio|0.826|||||TWO_SIDED|95.0|0.722|0.945||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.945|0.722|
73858062|NCT05858450|147261286|OTHER||Weighted Hazard Ratio|1.569|||||TWO_SIDED|95.0|1.088|2.264||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.264|1.088|
73858063|NCT05858450|147261286|OTHER||Weighted Hazard Ratio|1.118|||||TWO_SIDED|95.0|1.015|1.233||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.233|1.015|
73858064|NCT05858450|147261287|OTHER||Weighted Hazard Ratio|1.082|||||TWO_SIDED|95.0|0.911|1.286||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.286|0.911|
73858065|NCT05858450|147261287|OTHER||Weighted Hazard Ratio|0.932|||||TWO_SIDED|95.0|0.859|1.01||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.01|0.859|
73909719|NCT02298023|147349472|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.867|||||||Mixed Models Analysis|||||||0.867
73909720|NCT02298023|147349473|EQUIVALENCE|To test whether there were differences in the change of tear size among groups||||||0.916|||||||Chi-squared|||||||0.916
73909721|NCT02298023|147349474|EQUIVALENCE|To test whether there were differences in the change of tear size among groups||||||0.892|||||||Chi-squared|||||||0.892
73909722|NCT01967173|147349475|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250||||0.003
73909723|NCT01967173|147349475|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250||||0.9
73909724|NCT01967173|147349475|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 500 is equal to the inferiority of Advair 100/50 compared to Fluticasone 500||||<0.001
74085313|NCT04291508|147724380|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.4|TWO_SIDED|95.0|-3.4|8.5|||t-test, 2 sided|||||8.5|-3.4|0.40
74085314|NCT04291508|147724381|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.23|TWO_SIDED|95.0|-0.8|3.4|||t-test, 2 sided|||||3.4|-0.8|0.23
74085315|NCT04291508|147724381|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.22|TWO_SIDED|95.0|-2.2|9.4|||t-test, 2 sided|||||9.4|-2.2|0.22
73909725|NCT01967173|147349475|SUPERIORITY|||||||0.42|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50||||0.42
73909726|NCT01967173|147349475|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50||||0.84
73964818|NCT01843374|147465346|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.4081|TWO_SIDED|95.0|0.76|1.12||P-value was estimated using the method of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and Line of therapy.|Log Rank|The stratification factors included EORTC status and line of therapy as recorded in IVRS/IWRS.|Tremelimumab represents the numerator and Placebo the denominator|H0: No difference between tremelimumab and placebo H1: Difference between tremelimumab and placebo||1.12|0.76|0.4081
73909727|NCT01967173|147349475|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 500 is equal to the inferiority of Advair 250/50 compared to Fluticasone 500||||0.015
73909728|NCT01967173|147349475|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250||||0.085
73909729|NCT01967173|147349475|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250||||0.62
73909730|NCT01967173|147349475|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 500 compared to Fluticasone 250 is equal to the inferiority of Fluticasone 500 compared to Fluticasone 250||||0.48
73909731|NCT01967173|147349475|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 100 is equal to the inferiority of Advair 100/50 compared to Fluticasone 100||||0.14
73909732|NCT01967173|147349475|SUPERIORITY|||||||0.096|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 250 compared to Fluticasone 100 is equal to the inferiority of Fluticasone 250 compared to Fluticasone 100||||0.096
73964819|NCT01843374|147465347|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.011||||0.926|TWO_SIDED|95.0|0.793|1.289||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank||Tremelimumab is the numerator and Placebo the denominator|||1.289|0.793|0.926
73909733|NCT02663908|147349485|OTHER||Hazard Ratio (HR)|1.283||||0.5294|TWO_SIDED|95.0|0.589|2.794|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.794|0.589|0.5294
73909734|NCT02663908|147349486|OTHER||Hazard Ratio (HR)|1.204||||0.7126|TWO_SIDED|95.0|0.448|3.234|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||3.234|0.448|0.7126
73909735|NCT02663908|147349487|OTHER||Hazard Ratio (HR)|0.186||||0.0853|TWO_SIDED|95.0|0.022|1.595|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||1.595|0.022|0.0853
73909736|NCT02663908|147349488|OTHER||Hazard Ratio (HR)|1.594||||0.5196|TWO_SIDED|95.0|0.381|6.673|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||6.673|0.381|0.5196
73909737|NCT02663908|147349489|OTHER||Hazard Ratio (HR)|0.899||||0.8966|TWO_SIDED|95.0|0.181|4.457|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||4.457|0.181|0.8966
73909738|NCT02663908|147349490|OTHER||Hazard Ratio (HR)|0.48||||0.3857|TWO_SIDED|95.0|0.088|2.62|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.620|0.088|0.3857
73909739|NCT02663908|147349491|OTHER||Hazard Ratio (HR)|0.839||||0.718|TWO_SIDED|95.0|0.324|2.176|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.176|0.324|0.7180
73909740|NCT02663908|147349493|OTHER||Hazard Ratio (HR)|0.887||||0.6701|TWO_SIDED|95.0|0.512|1.539|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||1.539|0.512|0.6701
73909741|NCT02663908|147349494|OTHER||Treatment Difference|-0.907||||0.1193|TWO_SIDED|95.0|-2.048|0.235|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS Total at Day 168||0.235|-2.048|0.1193
73909742|NCT02663908|147349494|OTHER||Treatment Difference|-0.213||||0.108|TWO_SIDED|95.0|-0.473|0.047|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS, QoL at Day 168||0.047|-0.473|0.1080
74085316|NCT04291508|147724382|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.58|TWO_SIDED|95.0|-1.6|2.8|||t-test, 2 sided|||||2.8|-1.6|0.58
73964820|NCT01843374|147465348|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.0325|TWO_SIDED|95.0|0.68|0.98||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank|Stratification factors were EORTC status and Line of therapy|Tremelimumab is the numerator and placebo, the denominator|||0.98|0.68|0.0325
74026514|NCT01933672|147606470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.24|||||TWO_SIDED|80.0|-24.99|-13.5||||||Change from baseline||-13.50|-24.99|
74026515|NCT01933672|147606470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.99|||||TWO_SIDED|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.||-4.17|-19.81|
74026516|NCT01933672|147606470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||||TWO_SIDED|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.||-4.17|-19.81|
73858066|NCT03392883|147261354|OTHER|Paired version (T-test for paired sample, Friedman and McNemar tests) was used for contrasting the equality among the variables at different moments of time. In order to adjust our results by potential confounders, ANCOVA analyses was performed. Symmetric 95% confidence intervals will be provided for relevant parameters. All p-values were referred to two-sided hypotheses. P-values below 0.05 were considered statistically significant.|||||<|0.001|TWO_SIDED|95.0||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale. This Statistical Analysis describes the Adoption subscale results.||||<0.001
74085317|NCT04291508|147724382|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.13|TWO_SIDED|95.0|-1.4|10.5|||t-test, 2 sided|||||10.5|-1.4|0.13
73858067|NCT03392883|147261354|OTHER|||||||0.552||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Acceptability subscale results.||||0.552
73858068|NCT03392883|147261354|OTHER|||||||0.32||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Appropriateness subscale results.||||0.320
73858069|NCT03392883|147261354|OTHER|||||||0.879||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Feasibility subscale results.||||0.879
73858070|NCT03392883|147261354|OTHER|||||||0.242||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Reach/Access subscale results.||||0.242
73858071|NCT03392883|147261355|OTHER|||||||0.237||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.237
73858072|NCT03392883|147261355|OTHER|||||||0.492||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.||||0.492
73858073|NCT03392883|147261355|OTHER|||||||0.285||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.||||0.285
73858074|NCT03392883|147261355|OTHER|||||||0.964||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.||||0.964
73858075|NCT03392883|147261355|OTHER|||||||0.942||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Resources subscale results.||||0.942
73858076|NCT03392883|147261355|OTHER|||||||0.366||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Scope subscale results.||||0.366
73858077|NCT03392883|147261355|OTHER|||||||0.021||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.||||0.021
73858078|NCT03392883|147261355|OTHER|||||||0.832||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.||||0.832
73858079|NCT03392883|147261355|OTHER|||||||0.827||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.||||0.827
73858080|NCT03392883|147261356|OTHER|||||||0.118||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.118
73858081|NCT03392883|147261356|OTHER|||||||0.896||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.||||0.896
73858082|NCT03392883|147261356|OTHER|||||||0.739||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.||||0.739
73858083|NCT03392883|147261356|OTHER|||||||0.724||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.||||0.724
73858084|NCT03392883|147261356|OTHER|||||||0.301||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.301
73858085|NCT03392883|147261356|OTHER|||||||0.034||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.||||0.034
74026517|NCT01933672|147606471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.92|||||TWO_SIDED|80.0|-27.0|-16.85||||||Compared with Baseline||-16.85|-27.00|
74026518|NCT01933672|147606471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|||||TWO_SIDED|80.0|-26.3|-15.1||||||Compared with Baseline||-15.10|-26.30|
74026519|NCT01933672|147606471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.51|||||TWO_SIDED|80.0|-22.24|-10.78||||||Compared with Baseline||-10.78|-22.24|
74085318|NCT04291508|147724383|SUPERIORITY||Risk Difference (RD)|-4.3||||0.26|TWO_SIDED|95.0|-11.8|3.2|||Chi-squared|||||3.2|-11.8|0.26
74085319|NCT04291508|147724383|SUPERIORITY||Risk Difference (RD)|-13.6||||0.31|TWO_SIDED|95.0|-35.8|8.7|||Fisher Exact|||||8.7|-35.8|0.31
74085320|NCT04291508|147724384|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.76|TWO_SIDED|95.0|-1.6|2.2|||t-test, 2 sided|||||2.2|-1.6|0.76
73964821|NCT02605837|147465356|SUPERIORITY||Difference in proportion of responders|0.52|||<|0.001||95.0|0.433|0.591|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.||0.591|0.433|<0.001
73964822|NCT02605837|147465357|SUPERIORITY||Difference in proportion of responders|0.13||||0.024||95.0|0.016|0.243|||Cochran-Mantel-Haenszel|||The CMH adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.||0.243|0.016|0.024
73964823|NCT02605837|147465358|SUPERIORITY||Difference in Least square mean|-3.92||||0.015||95.0|-7.073|-0.774|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ combined score as a continuous covariate.||-0.774|-7.073|0.015
73964824|NCT02605837|147465359|SUPERIORITY||Difference in Least square mean|-1.8|||<|0.001||95.0|-2.6|-1.1|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline. Total EREFS (endoscopy score) as a continuous covariate.||-1.1|-2.6|<0.001
73964825|NCT02605837|147465360|SUPERIORITY||Odds Ratio (OR)|169.74|||<|0.001||95.0|23.235|1239.979|||Regression, Logistic|||Peak eosinophil count (\<15/HPF) was performed based on logistic regression model adjusted for age group and diet restriction.||1239.979|23.235|<0.001
73964826|NCT02605837|147465360|SUPERIORITY||Odds Ratio (OR)|100.69||||0.001|TWO_SIDED|95.0|6.294|1610.749|||Firth logistic regression|||Peak eosinophil count (\<=1/HPF) was performed based on firth logistic regression model adjusted for age group and diet restriction.||1610.749|6.294|0.001
73964827|NCT02605837|147465361|SUPERIORITY||Difference in Least square mean|-28.4|||<|0.001||95.0|-35.0|-21.8|||ANCOVA|||This analysis of proximal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-21.8|-35.0|<0.001
74026520|NCT01933672|147606471|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.41|||||TWO_SIDED|80.0|-11.74|0.92||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject's period-specific baseline response included, as fixed covariates.||0.92|-11.74|
74026521|NCT01933672|147606471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|80.0|-10.86|2.49||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject's period-specific baseline response included, as fixed covariates.||2.49|-10.86|
74085321|NCT04291508|147724384|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.78|TWO_SIDED|95.0|-4.9|6.5|||t-test, 2 sided|||||6.5|-4.9|0.78
73858086|NCT03392883|147261356|OTHER|||||||0.015||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.||||0.015
73858087|NCT03392883|147261356|OTHER|||||||0.081||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.||||0.081
73858088|NCT03392883|147261356|OTHER|||||||0.79||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Knowledge subscale results.||||0.790
73964828|NCT02605837|147465361|SUPERIORITY||Difference in Least square mean|-30.4|||<|0.001||95.0|-38.1|-22.7|||ANCOVA|||This analysis of mid eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-22.7|-38.1|<0.001
73858089|NCT03392883|147261357|OTHER|||||||0.023||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes in the overall scores over time.||||0.023
73964829|NCT02605837|147465361|SUPERIORITY||Difference in Least square mean|-33.1|||<|0.001||95.0|-40.7|-25.5|||ANCOVA|||This analysis of distal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate||-25.5|-40.7|<0.001
73858090|NCT03392883|147261358|OTHER|||||||0.589||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes in the overall scores over time in this data.||||0.589
73858091|NCT03392883|147261359|OTHER||Mean Difference (Net)|-6.65|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.||||
73964830|NCT02605837|147465361|SUPERIORITY||Difference in LS Mean|-47.6|||<|0.001|TWO_SIDED|95.0|-56.4|-38.8|||ANCOVA|||This analysis of maximum eosinophil count was from the ANCOVA model with treatment group and age group as factors and the baseline Peak eosinophil count as a continuous covariate.||-38.8|-56.4|<0.001
73964831|NCT02605837|147465362|SUPERIORITY||Difference in Least square mean|-0.19|||<|0.001||95.0|-0.22|-0.16|||ANCOVA|||This analysis of histopathologic epithelial features combined grade TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-0.16|-0.22|<0.001
74026522|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|80.0|-0.19|0.07||||||Compared with Baseline （Pre-breakfast）||0.07|-0.19|
74026523|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|80.0|-0.09|0.21||||||Compared with Baseline (Pre-breakfast)||0.21|-0.09|
74026524|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|80.0|0.16|0.45||||||Compared with Baseline (Pre-breakfast)||0.45|0.16|
74085322|NCT04291508|147724385|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.3|1.9|||t-test, 2 sided|||||1.9|-2.3|0.84
74085323|NCT04291508|147724385|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.1|TWO_SIDED|95.0|-0.9|10.0|||t-test, 2 sided|||||10.0|-0.9|0.10
74085324|NCT04291508|147724386|SUPERIORITY||Risk Difference (RD)|-1.3||||0.79|TWO_SIDED|95.0|-10.9|8.3|||Chi-squared|||||8.3|-10.9|0.79
74085325|NCT04291508|147724386|SUPERIORITY||Risk Difference (RD)|4.9||||1|TWO_SIDED|95.0|-17.5|27.3|||Fisher Exact|||||27.3|-17.5|1.00
73909743|NCT02663908|147349494|OTHER||Treatment Difference|-0.916||||0.1256|TWO_SIDED|95.0|-2.089|0.257|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS Total at Day 336||0.257|-2.089|0.1256
73909744|NCT02663908|147349494|OTHER||Treatment Difference|-0.047||||0.7261|TWO_SIDED|95.0|-0.312|0.218|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS, QoL at Day 336||0.218|-0.312|0.7261
74026525|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|80.0|-0.56|-0.36||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.36|-0.56|
74026526|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|||||TWO_SIDED|80.0|-0.45|-0.03||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.03|-0.45|
74026527|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|80.0|-0.08|0.48||||||Compared with Baseline (Pre-lunch)||0.48|-0.08|
74026528|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|80.0|0.38|1.03||||||Compared with Baseline (Pre-lunch)||1.03|0.38|
74026529|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|80.0|-0.26|0.37||||||Compared with Baseline (Pre-lunch)||0.37|-0.26|
74026530|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||||80.0|-0.28|0.57||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.57|-0.28|
73858092|NCT03392883|147261360|OTHER||Mean Difference (Net)|-4.48|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the total scores (sum of 12 items) at baseline assessment and at 12-month follow-up assessment.||||
73909745|NCT02663908|147349498|OTHER||Treatment difference|-0.002||||0.911|TWO_SIDED|95.0|-0.036|0.032|||ANCOVA|Compared using an ANCOVA model, where the QALY is the dependent variable and adjusted for treatment group, age group and region, respectively.||||0.032|-0.036|0.9110
73909746|NCT02663908|147349499|OTHER||Treatment Difference|-1.57||||0.0936|TWO_SIDED|95.0|-3.41|0.27|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||DASI at Day 168||0.27|-3.41|0.0936
73909747|NCT02663908|147349499|OTHER||Treatment Difference|0.84||||0.4|TWO_SIDED|95.0|-1.11|2.78|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||DASI at Day 336||2.78|-1.11|0.4000
73858093|NCT03392883|147261361|OTHER||Mean Difference (Net)|-5.77|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.||||
73858094|NCT03392883|147261362|OTHER||Mean Difference (Net)|-2.59|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the number of standard drinks per week at baseline assessment and at 12-month follow-up assessment.||||
73909748|NCT02663908|147349500|OTHER||Treatment Difference|0.045||||0.2535|TWO_SIDED|95.0|-0.032|0.122|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ Global Score at Day 168||0.122|-0.032|0.2535
73909749|NCT02663908|147349500|OTHER||Treatment Difference|0.036||||0.437|TWO_SIDED|95.0|-0.055|0.127|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Attention at Day 168||0.127|-0.055|0.4370
73909750|NCT02663908|147349500|OTHER||Treatment Difference|0.116||||0.0852|TWO_SIDED|95.0|-0.016|0.248|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Avoidance at Day 168||0.248|-0.016|0.0852
73909751|NCT02663908|147349500|OTHER||Treatment Difference|0.012||||0.8156|TWO_SIDED|95.0|-0.087|0.111|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Fear at Day 168||0.111|-0.087|0.8156
73909752|NCT02663908|147349500|OTHER||Treatment Difference|0.051||||0.2299|TWO_SIDED|95.0|-0.033|0.135|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ Global Score at Day 336||0.135|-0.033|0.2299
73909753|NCT02663908|147349500|OTHER||Treatment Difference|0.038||||0.444|TWO_SIDED|95.0|-0.06|0.136|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Attention at Day 336||0.136|-0.060|0.4440
73909754|NCT02663908|147349500|OTHER||Treatment Difference|0.007||||0.9172|TWO_SIDED|95.0|-0.131|0.146|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Avoidance at Day 336||0.146|-0.131|0.9172
73909755|NCT02663908|147349500|OTHER||Treatment Difference|0.093||||0.1028|TWO_SIDED|95.0|-0.019|0.204|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Fear at Day 336||0.204|-0.019|0.1028
73909756|NCT04508335|147349543|EQUIVALENCE|We use 2, one-sided t-tests, each with alpha set at 0.05 to test the composite null hypothesis that the mean difference score (μReia-μCurrent) between the Reia pessary and baseline (current pessary) on the PFDI-20, is greater than 18.3 (H01), the upper equivalence limit, or lower than -18.3 (H02), the lower equivalence limit.||||||0.0021|||||||t-test, 2 sided|||H01: μReia-μCurrent \> 18.3 and H02: μReia-μCurrent \< -18.3. The alternative hypothesis is thus: HA: -18.3 ≤ μReia-μCurrent ≤ 18.3.||||.0021
73909757|NCT04508335|147349545|OTHER|Mean difference of PFIQ scores. A negative difference (Reia pessary - current pessary) indicates that the PFIQ-7 score improved with the Reia pessary.|Mean Difference (Final Values)|-11.9||||0.0192|TWO_SIDED|||||p value adjusted for multiple variables|Wilcoxon (Mann-Whitney)|||PFIQ scores at baseline with subjects using current pessary then after treatment with Reia pessary||||0.0192
73909758|NCT03792191|147349572|SUPERIORITY||Median Difference (Final Values)|0.00007||||0.62|TWO_SIDED|95.0|-0.00005|1.0|||Wilcoxon (Mann-Whitney)|||||1|-0.00005|0.62
73909759|NCT03792191|147349573|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
73909760|NCT03792191|147349574|SUPERIORITY||Risk Difference (RD)|-0.036||||0.6|TWO_SIDED|95.0|-0.15|0.079|||Chi-squared, Corrected|||||0.079|-0.15|0.6
73909761|NCT03792191|147349575|SUPERIORITY||Risk Difference (RD)|-0.021||||0.77|TWO_SIDED|95.0|-0.125|0.082|||Chi-squared, Corrected|||||0.082|-0.125|0.77
73909762|NCT03792191|147349576|SUPERIORITY||Median Difference (Final Values)|8.0||||0.077|TWO_SIDED|95.0|-1.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|-1|0.077
73909763|NCT03792191|147349577|SUPERIORITY||Median Difference (Final Values)|0.00003||||0.1|TWO_SIDED|95.0|-0.00001|0.00003|||Wilcoxon (Mann-Whitney)|||||0.00003|-0.00001|0.1
73909764|NCT03792191|147349578|SUPERIORITY||||||>|0.99|||||||Chi-squared, Corrected|||||||>0.99
73909765|NCT03792191|147349579|SUPERIORITY||||||>|0.99|||||||Chi-squared, Corrected|||||||>0.99
74026531|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|||||TWO_SIDED|80.0|0.19|1.11||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||1.11|0.19|
74085326|NCT04291508|147724387|SUPERIORITY||Risk Difference (RD)|1.7||||0.53|TWO_SIDED|95.0|-3.7|7.2|||Chi-squared|||||7.2|-3.7|0.53
74085327|NCT04291508|147724387|SUPERIORITY||Risk Difference (RD)|-2.0||||1|TWO_SIDED|95.0|-17.0|13.0|||Fisher Exact|||||13.0|-17.0|1.00
73909766|NCT03792191|147349581|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
73909767|NCT03917459|147349613|OTHER||LS mean of treatment difference|2.9|STANDARD_ERROR_OF_MEAN|2.94||0.3432|TWO_SIDED|95.0|-3.29|9.01|||Mixed Model Repeated Measures (MMRM)|||||9.01|-3.29|0.3432
73909768|NCT00491764|147349616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9||||0.005||95.0|8.9|36.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||36.8|8.9|0.005
73909769|NCT00491764|147349616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|54.1|||<|0.001||95.0|38.0|70.1|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||70.1|38.0|<0.001
73909770|NCT00491764|147349616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.5|||<|0.001||95.0|28.5|62.4|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||62.4|28.5|<0.001
73909771|NCT00491764|147349616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.012||95.0|6.7|33.3|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||33.3|6.7|0.012
73909772|NCT00491764|147349616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.1|||<|0.001||95.0|21.1|53.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||53.2|21.1|<0.001
73909773|NCT00491764|147349617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.7||||0.002||95.0|11.2|40.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||40.2|11.2|0.002
73909774|NCT00491764|147349617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||80.2|49.5|<0.001
73909775|NCT00491764|147349617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|48.5|||<|0.001||95.0|31.4|65.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||65.5|31.4|<0.001
73909776|NCT00491764|147349617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
73909777|NCT00491764|147349617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|54.3|||<|0.001||95.0|37.8|70.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||70.8|37.8|<0.001
73909778|NCT00491764|147349618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
73909779|NCT00491764|147349618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||80.2|49.5|<0.001
73909780|NCT00491764|147349618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.7|||<|0.001||95.0|50.6|82.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||82.8|50.6|<0.001
73909781|NCT00491764|147349618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
73909782|NCT00491764|147349618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.1|||<|0.001||95.0|40.7|73.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||73.5|40.7|<0.001
74026532|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|80.0|0.03|0.68||||||Compared with Baseline (Pre-dinner)||0.68|0.03|
74026533|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|80.0|-0.08|0.67||||||Compared with Baseline (Pre-dinner)||0.67|-0.08|
74085328|NCT04291508|147724388|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.9|0.6|||t-test, 2 sided|||||0.6|-0.9|0.70
74085329|NCT04291508|147724388|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.96|TWO_SIDED|95.0|-2.7|2.5|||t-test, 2 sided|||||2.5|-2.7|0.96
74085330|NCT04291508|147724389|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-2.3|7.3|||Fisher Exact|||||7.3|-2.3|1.00
74085331|NCT04291508|147724390|SUPERIORITY||Risk Difference (RD)|-4.4||||0.31|TWO_SIDED|95.0|-13.1|4.2|||Chi-squared|||||4.2|-13.1|0.31
74085332|NCT04291508|147724390|SUPERIORITY||Risk Difference (RD)|-27.9||||0.02|TWO_SIDED|95.0|-51.7|-4.0|||Chi-squared|||||-4.0|-51.7|0.02
74085333|NCT04291508|147724391|SUPERIORITY||Risk Difference (RD)|-0.5||||0.9|TWO_SIDED|95.0|-8.5|7.5|||Chi-squared|||||7.5|-8.5|0.90
74085334|NCT04291508|147724391|SUPERIORITY||Risk Difference (RD)|-27.9||||0.02|TWO_SIDED|95.0|-51.7|-4.0|||Chi-squared|||||-4.0|-51.7|0.02
74085335|NCT04291508|147724392|SUPERIORITY||Risk Difference (RD)|-7.3||||0.003|TWO_SIDED|95.0|-12.2|-2.4|||Chi-squared|||||-2.4|-12.2|0.003
74085336|NCT04291508|147724392|SUPERIORITY||Risk Difference (RD)|6.7||||0.52|TWO_SIDED|95.0|-2.3|15.6|||Fisher Exact|||||15.6|-2.3|0.52
74085337|NCT04291508|147724393|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.68|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||||0.2|-0.2|0.68
73858095|NCT00132691|147261412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.03||0.16|TWO_SIDED|95.0|-1.16|6.68||unadjusted|Generalized estimating equations, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|"Null hypothesis: There will be no difference in change in visual acuity between treatment groups.~Assuming 67% bilateral disease, between eye correlation of 0.4, SD of 16 letters' change over 2 years and two-sided type 1 error rate of .05, a sample size of 250 provided 91% power (assuming 10% crossover) to detect a treatment difference of 7.5 standard ETDRS letters' change in visual acuity from baseline to 24 months."||6.68|-1.16|0.16
73858096|NCT00132691|147261413|SUPERIORITY_OR_OTHER||Ratio of odds ratios|0.61||||0.071|TWO_SIDED|95.0|0.34|1.03||unadjusted|GEE, logistic||For each treatment group the odds of macular edema at 2 yrs as compared to baseline was computed. The treatment effect is the ratio of these odds (implant divided by systemic).|||1.03|0.34|0.071
73858097|NCT00132691|147261414|SUPERIORITY_OR_OTHER||Ratio of odds ratios|0.29||||0.001|TWO_SIDED|95.0|0.13|0.6||unadjusted|GEE, logistic||For each treatment group the odds of uveitis activity at 2 years as compared to baseline was computed. The treatment effect represents the ratio of these odds (implant divided by systemic).|||.60|.13|0.001
73858098|NCT00132691|147261415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.08|||<|0.0001|TWO_SIDED|95.0|3.32|11.15||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 30 mmHg or greater. The systemic arm was the reference group.|||11.15|3.32|<.0001
73858099|NCT00132691|147261416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.34|5.5||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 24 mmHg or greater. The systemic arm was the reference group|||5.50|2.34|<.0001
73858100|NCT00132691|147261417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.78|6.58||unadjusted|Cox proportional hazards with RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP that was 10mmHg or greater than the baseline value. The systemic arm was the reference group.|||6.58|2.78|<.0001
73858101|NCT00132691|147261418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.19||||0.0008|TWO_SIDED|95.0|1.82|9.63||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing glaucoma. The systemic arm was the reference group.|||9.63|1.82|0.0008
73858102|NCT00132691|147261419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.16|||<|0.0001|TWO_SIDED|95.0|2.67|6.47||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of using an IOP-lowering therapy. The systemic arm was the reference group.|||6.47|2.67|<.0001
73858103|NCT00132691|147261420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|8.4|||<|0.0001|TWO_SIDED|95.0|3.39|20.82||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of having surgery to lower IOP. The systemic arm was the reference group.|||20.82|3.39|<0.0001
73858104|NCT00132691|147261421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.21|7.67||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing a cataract. The systemic arm was the reference group.|||7.67|2.21|<0.0001
73858105|NCT00132691|147261422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.64|STANDARD_ERROR_OF_MEAN|2.3||0.043|TWO_SIDED|95.0|0.14|9.15||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|||9.15|0.14|0.043
73858106|NCT00132691|147261423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.62|STANDARD_ERROR_OF_MEAN|1.6||0.023|TWO_SIDED|95.0|0.49|6.76||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic)|||6.76|0.49|0.023
74085338|NCT04291508|147724393|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.62|TWO_SIDED|95.0|-0.7|0.4|||Fisher Exact|||||0.4|-0.7|0.62
73858107|NCT00132691|147261424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.95|STANDARD_ERROR_OF_MEAN|1.23||0.016|TWO_SIDED|95.0|0.54|5.36||unadjusted|Generalized Estimating Equations||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|||5.36|0.54|0.016
73858108|NCT00132691|147261425|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.84|TWO_SIDED|95.0|0.39|2.15||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hyperlipidemia for the implant and systemic treatments. The systemic treatment is the reference group.|||2.15|0.39|0.84
73858109|NCT00132691|147261426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.13|TWO_SIDED|95.0|0.13|1.29||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hypertension for the implant and systemic treatments. The systemic treatment is the reference group.|||1.29|0.13|0.13
73909783|NCT01479478|147349619|SUPERIORITY|||||||0.87|||||||Cochran-Mantel-Haenszel|||||||0.87
73909784|NCT01188421|147349652|SUPERIORITY||F-value for main effect of Group|1.31||||0.275|TWO_SIDED|||||Main effect of Group (e.g., Buprenorphine, Tramadol, Clonidine) on COWS Total Score Ratings|ANOVA|||A power analysis determined 40 participants in each group would detect a moderate effect size, assuming an alpha of 0.05 and 80% power. Due to the expiration of buprenorphine tablets, recruitment was terminated after enrolling 103 participants. This study utilized an Intent-to-Treat (ITT) analysis. The ITT analysis includes all volunteers who signed informed consent, were randomized into the study's treatment conditions, and took at least 1 dose of study medication.||||.275
73909785|NCT01188421|147349652|SUPERIORITY||F-value for main effect of Phase|3.57||||0.03|TWO_SIDED|||||Main effect for Phase (e.g., Stabilization, Taper, Post-Taper) on COWS total score.|ANOVA|||||||0.03
73909786|NCT01188421|147349652|SUPERIORITY||F-value for the main effect of Group x P|2.03||||0.092|TWO_SIDED|||||Main effect for Group x Phase interaction on COWS Total Score|ANOVA|||||||0.092
73909787|NCT00075218|147349653|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.329|||<|0.001||95.0|0.233|0.466||The nominal levels of significance for the interim and final analyses were determined at the time of the analyses using the Lan-DeMets procedure with an O'Brien-Fleming stopping rule.|Log Rank|two-sided unstratified log-rank test||The study was designed to test the null hypothesis that the median TTP from placebo treatment is 4 months versus the alternative hypothesis that the median TTP from sunitinib treatment is at least 6 months with an overall 2-sided significance level of 0.05 and power of 90%.||0.466|0.233|<0.001
73909788|NCT00075218|147349654|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.347|||<|0.001||95.0|0.253|0.475||No p-value adjustment for multiple comparisons.|Log Rank|||||0.475|0.253|<0.001
73909789|NCT00075218|147349656|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.876||||0.306||95.0|0.679|1.129||No p-value adjustment for multiple comparisons.|Log Rank|||||1.129|0.679|0.306
73909790|NCT00075218|147349657|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.505||||0.306||95.0|0.262|1.134||No p-value adjustment for multiple comparisons.|Rank Preserving Structural Failure Time||95% CI for Hazard Ratio is from 2.5% and 97.5% Empirical Percentiles of 100,000 Bootstraps.|||1.134|0.262|0.306
73909791|NCT00075218|147349659|SUPERIORITY_OR_OTHER||rate (percentage)|6.6||||||95.0|3.8|10.5|||||Used exact method based on binomial distribution.|||10.5|3.8|
73964832|NCT02605837|147465362|SUPERIORITY||Difference in Least square mean|-0.2|||<|0.001||95.0|-0.2|-0.2|||ANCOVA|||This analysis of histopathologic epithelial features combined stage TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-0.2|-0.2|<0.001
73909792|NCT00075218|147349659|SUPERIORITY_OR_OTHER||Treatment Difference (%)|6.58||||0.004||95.0|3.47|9.7||No p-value adjustment for multiple comparisons.|Pearson chi-square test|||||9.70|3.47|0.004
73909793|NCT00075218|147349662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.339|||<|0.001||95.0|0.244|0.472||two-sided unstratified log-rank test|Log Rank|||||0.472|0.244|<0.001
73909794|NCT00075218|147349662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.327|||<|0.001||95.0|0.232|0.46|||Log Rank|log-rank test of treatment stratified by prior imatinib mesylate response and McGill Pain Questionnaire's Present Pain Intensity score||Stratified log-rank test||0.460|0.232|<0.001
73909795|NCT00075218|147349663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.972||||0.9322||95.0|0.508|1.86|||Log Rank|2-sided, unstratified log-rank test||||1.860|0.508|0.9322
73909796|NCT00075218|147349664|SUPERIORITY_OR_OTHER||Treatment Difference (percent)|17.3||||0.0046||95.0|6.7|28.0|||Pearson chi-square||95% CI of Difference based on normal distribution. Percent = (number of subjects with response per total subjects per treatment in defined analysis population)\*100.|||28.0|6.7|0.0046
73909797|NCT03840174|147349670|OTHER||GMT Ratio|77.7|||||TWO_SIDED|95.0|23.9|252.4|||||Geometric Mean Titer (GMT) ratio and 95% CI were estimated using an ANOVA model.|||252.4|23.9|
73909798|NCT00131508|147349674|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in REE ratio between the placebo and glutamine groups. The study was designed to provide 80% power at an alpha level of 0.05 for this objective. Due to slow accrual, the sample size of 46 participants required to obtain the designed power of the study was not realized.||||0.17
73909799|NCT00131508|147349675|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change of body mass index between the placebo and glutamine groups.||||0.53
73909800|NCT00131508|147349676|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in red blood cell glutamine between the placebo and glutamine groups.||||0.24
73909801|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported physical function in the placebo and glutamine groups.||||0.62
73909802|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported emotional function in the placebo and glutamine groups.||||0.14
73909803|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported social function in the placebo and glutamine groups.||||0.20
73909804|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported school function in the placebo and glutamine groups.||||0.62
73909805|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported physical function in the placebo and glutamine groups.||||0.61
73909806|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported emotional function in the placebo and glutamine groups.||||0.65
73909807|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported social function in the placebo and glutamine groups.||||0.55
73909808|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported school function in the placebo and glutamine groups.||||0.69
73964833|NCT02605837|147465363|SUPERIORITY||Odds Ratio (OR)|1.42||||0.164|TWO_SIDED|95.0|0.866|2.333|||Regression, Logistic|||Dysphagia symptom response (binary response) at the final treatment period was performed based on logistic regression model adjusted for age group and diet restriction.||2.333|0.866|0.164
73964834|NCT02605837|147465364|SUPERIORITY||Odds Ratio (OR)|91.86||||0.001|TWO_SIDED|95.0|5.687|1483.68|||Firth logistic regression|||Overall binary response I at the final treatment period was performed based on firth logistic regression model adjusted for age group and diet restriction.||1483.680|5.687|0.001
73964835|NCT02605837|147465365|SUPERIORITY||Odds Ratio (OR)|61.68||||0.004|TWO_SIDED|95.0|3.836|991.858|||Firth logistic regression|||Overall binary response II at the final treatment period was perfomed based on based on firth logistic regression model adjusted for age group and diet restriction.||991.858|3.836|0.004
74026534|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|80.0|-0.05|0.68||||||Compared with Baseline (Pre-dinner)||0.68|-0.05|
74085339|NCT04291508|147724394|SUPERIORITY||Risk Difference (RD)|0.5||||0.9|TWO_SIDED|95.0|-7.8|8.8|||Chi-squared|||||8.8|-7.8|0.90
73858110|NCT00132691|147261427|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.24|TWO_SIDED|95.0|0.03|2.44||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of diabetes mellitus for the implant and systemic treatments. The systemic treatment is the reference group.|||2.44|0.03|0.24
73858111|NCT04098367|147261433|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|30.6|||||TWO_SIDED|97.5|13.34|46.79|||Miettinen-Nurminen||VIVITY minus SYMFONY|||46.79|13.34|
73858112|NCT04098367|147261433|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|30.1|||||TWO_SIDED|97.5|12.54|46.68|||Miettinen-Nurminen||VIVITY minus AT LARA|||46.68|12.54|
73858113|NCT04098367|147261434|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|-2.3|||||TWO_SIDED|97.5|-21.91|17.42|||Miettinen-Nurminen||VIVITY minus SYMFONY|||17.42|-21.91|
73858114|NCT04098367|147261434|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|8.2|||||TWO_SIDED|97.5|-12.0|27.8|||Miettinen-Nurminen||VIVITY minus AT LARA|||27.80|-12.00|
73858115|NCT04098367|147261435|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|23.5|||||TWO_SIDED|97.5|4.66|40.86|||Miettinen-Nurminen||VIVITY minus SYMFONY|||40.86|4.66|
73858116|NCT04098367|147261435|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|40.7|||||TWO_SIDED|97.5|21.16|57.22|||Miettinen-Nurminen||VIVITY minus AT LARA|||57.22|21.16|
73858117|NCT01528891|147261522|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Heart rate values at each time point were compared between groups.||||<0.01
73858118|NCT01528891|147261522|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.||||<0.01
73858119|NCT01528891|147261522|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.||||<0.01
73858120|NCT01528891|147261523|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P\<0.0001 was calculated for both groups.|Fisher Exact|||The incidence of agitated patients in each group was compared.||||<0.0001
73858121|NCT01528891|147261524|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points: 1 minute, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Systolic blood pressure values were compared between groups at each time point.||||<0.01
73858122|NCT01528891|147261524|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 1 minute, 3 minutes, 4 minutes, and 5 minutes.~P-values are adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline value within each group over time.||||<0.01
73858123|NCT01528891|147261524|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 5 minutes and PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline within each group over time.||||<0.01
73858124|NCT01528891|147261525|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points: 1 minute and PACU.~P-values were adjusted for multiple comparisons."|t-test, 2 sided|||DBP values were compared between groups at each time point.||||<0.01
73858125|NCT01528891|147261525|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to baseline: 1 minute, 3 minutes, 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared within each group against the baseline value.||||<0.01
73858126|NCT01528891|147261525|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to baseline: 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared against the baseline value within each group over time.||||<0.01
73964836|NCT02605837|147465366|SUPERIORITY||Difference in Least square mean|-6.41||||0.004||95.0|-10.757|-2.063|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ + Pain score as a continuous covariate.||-2.063|-10.757|0.004
74026535|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|80.0|-0.45|0.53||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.53|-0.45|
74085340|NCT04291508|147724394|SUPERIORITY||Risk Difference (RD)|-15.6||||0.2|TWO_SIDED|95.0|-40.1|8.9|||Chi-squared|||||8.9|-40.1|0.2
74085341|NCT04291508|147724395|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.88|TWO_SIDED|95.0|-1.1|1.3|||t-test, 2 sided|||||1.3|-1.1|0.88
74085342|NCT04291508|147724395|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.1|TWO_SIDED|95.0|-0.6|6.6|||t-test, 2 sided|||||6.6|-0.6|0.10
74088502|NCT03923699|147730408|SUPERIORITY||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.98|1.02||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.02|0.98|0.99
73964837|NCT02605837|147465367|SUPERIORITY||Difference in Least square mean|-2.46||||0.002||95.0|-4.018|-0.909|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ Pain score as a continuous covariate.||-0.909|-4.018|0.002
73964838|NCT02652260|147465376|OTHER|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|4.65||||0.331|TWO_SIDED|95.0|-15.92|24.85|||Miettinen and Nurminen|||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% confidence interval (CI) was calculated by the method of Miettinen and Nurminen.|24.85|-15.92|0.331
73964839|NCT02652260|147465377|OTHER|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|-18.61|||||TWO_SIDED|95.0|-38.14|2.51||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.|2.51|-38.14|
73858127|NCT04452435|147261526|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.4891|||||||ANCOVA|||||||=0.4891
73858128|NCT04452435|147261526|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0881|||||||ANCOVA|||A subgroup analyses was performed in subjects with supplemental oxygen use at baseline. A total of 26 subjects in the C21 group and 27 in the placebo group were included in the analysis of change in CRP from baseline to the mean of the last 2 non-missing scheduled assessments during the treatment period by baseline supplemental oxygen use.||||=0.0881
73858129|NCT04452435|147261527|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0492|||||||ANCOVA|||||||=0.0492
73858130|NCT04452435|147261528|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9923|||||||ANCOVA|||||||=0.9923
73858131|NCT04452435|147261529|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.5355|||||||ANCOVA|||||||=0.5355
73858132|NCT04452435|147261530|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.4738|||||||ANCOVA|||||||=0.4738
73858133|NCT04452435|147261531|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9418|||||||ANCOVA|||||||=0.9418
73858134|NCT04452435|147261532|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9733|||||||ANCOVA|||||||=0.9733
73858135|NCT04452435|147261533|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0568|||||||Regression, Logistic|||||||=0.0568
73858136|NCT04452435|147261534|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.6088|||||||Regression, Logistic|||||||=0.6088
73858137|NCT04452435|147261535|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.5757|||||||Log Rank|||||||=0.5757
73858138|NCT04452435|147261536|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.8588|||||||Wilcoxon (Mann-Whitney)|||||||=0.8588
73858139|NCT04452435|147261538|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.003|||||||Chi-squared|||||||=0.003
73858140|NCT04699032|147261639|OTHER|Analysis of variance (ANOVA) was used to compare the natural log transformed Cmax for apraglutide between normal renal function group (Reference) and the severe impaired renal group (Test). Estimates of the mean differences and corresponding 90% confidence intervals (CIs) were obtained from the model. The mean differences and 90% CIs for the mean differences were exponentiated to provide estimates of the geometric least-square mean ratio (Test/Reference) and 90% CIs for the ratios.|Geometric least-square mean ratio|0.62|||||TWO_SIDED|90.0|0.423|0.909||||||||0.909|0.423|
73858141|NCT04699032|147261640|OTHER|ANOVA was used to compare the natural log transformed AUCinf for apraglutide between normal renal function group (Reference) and the severe impaired renal group (Test). Estimates of the mean differences and corresponding 90% CIs were obtained from the model. The mean differences and 90% CIs for the mean differences were exponentiated to provide estimates of the geometric least-square mean ratio (Test/Reference) and 90% CIs for the ratios.|Geometric least-square mean ratio|0.694|||||TWO_SIDED|90.0|0.458|1.05||||||||1.050|0.458|
73858142|NCT01271712|147261643|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-06|||||||Log Rank|stratified||The two treatment groups were compared using a stratified log rank test with a one-sided alpha of 0.01 stratified by (3rd vs 4th-line; and geographical region). The null hypothesis that both treatment arms have the same PFS distribution was tested against the alternative hypothesis that the distribution of PFS in the regorafenib arm is different from the control arm according to a proportional hazards relation between the treatment arms.||||<0.000001
73964840|NCT02652260|147465378|OTHER||Estimated Difference|-2.0|||||TWO_SIDED|95.0|-10.5|6.5||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was based on a t-distribution.|6.5|-10.5|
73909809|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported physical function in the placebo and glutamine groups.||||0.82
73909810|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported emotional function in the placebo and glutamine groups.||||0.99
73858143|NCT01271712|147261643|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.268|||||TWO_SIDED|95.0|0.185|0.388|||Regression, Cox|stratified|regorafenib over placebo|Hazard ratio and its 95% CI (Confidence Interval) was based on stratified Cox Regression Model||0.388|0.185|
73909811|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported social function in the placebo and glutamine groups.||||0.30
73909812|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported school function in the placebo and glutamine groups.||||0.24
73909813|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported physical function in the placebo and glutamine groups.||||0.50
73909814|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported emotional function in the placebo and glutamine groups.||||0.45
73909815|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported social function in the placebo and glutamine groups.||||0.46
73909816|NCT00131508|147349677|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported school function in the placebo and glutamine groups.||||0.84
73909817|NCT00131508|147349678|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.20
73909818|NCT00131508|147349678|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.81
73909819|NCT00131508|147349678|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months differs between the Glutamine and Placebo groups.||||0.70
73909820|NCT00131508|147349679|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.69
73909821|NCT00131508|147349679|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.75
73909822|NCT00131508|147349679|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in height percentile between baseline and 12 months differs between the Glutamine and Placebo groups.||||0.93
73909823|NCT00131508|147349680|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.56
73909824|NCT00131508|147349680|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||1.0
73909825|NCT00131508|147349680|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in weight percentile between baseline and 12 months differs between the Glutamine and Placebo groups.||||0.61
73909826|NCT00131508|147349681|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in pulse rate between the placebo and glutamine groups.||||0.83
73909827|NCT00131508|147349682|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in hand grip between the placebo and glutamine groups.||||0.40
73858144|NCT01271712|147261644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.285777|||||||Log Rank|stratified||||||0.285777
73858145|NCT01271712|147261644|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.909|||||TWO_SIDED|95.0|0.653|1.265|||Regression, Cox|stratified|regorafenib over control. 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015.|Hazard ratio and its 95% CI was based on stratified Cox Regression Model||1.265|0.653|
73858146|NCT01271712|147261645|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-06|||||||Log Rank|stratified||||||<0.000001
73858147|NCT01271712|147261645|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.248|||||TWO_SIDED|95.0|0.17|0.364|||Regression, Cox|stratified||||0.364|0.170|
73858148|NCT05479097|147261673|SUPERIORITY||Median Difference (Net)|-7.5||||0.03232|TWO_SIDED|95.0|-12.0|-1.0||A priori threshold for statistical significance was P \<0.05.|Wilcoxon signed rank test|Systolic blood pressure was not normally distributed in the study sample, so nonparametric analysis was used.||The null hypothesis was that there was no change in systolic blood pressure.||-1.0|-12.0|0.03232
73858149|NCT05479097|147261674|SUPERIORITY||Mean Difference (Net)|-3.1||||0.045|TWO_SIDED|95.0|-6.1|-0.1||The a priori threshold for statistical significance was P \<0.05.|t-test, 2 sided|As diastolic blood pressure was normally distributed in our sample, we used a paired t-test to evaluate the mean difference in measurements.||The null hypothesis was that there was no change in diastolic blood pressure.||-0.1|-6.1|0.045
73858150|NCT05479097|147261675|SUPERIORITY|||||||0.7237||||||The a priori threshold for statistical significance was P \<0.05|McNemar|||The null hypothesis was no change in the proportion of patients with systolic blood pressure well-controlled (\<=140 mmHg) from baseline to 6 months.||||0.7237
73909828|NCT04269707|147349683|NON_INFERIORITY|Change in hemoglobin from baseline to day 35 was assessed using paired t-tests (two-sided test, alpha = 0.05).|Mean Difference (Final Values)|0.7||||0.1711|TWO_SIDED|95.0|-0.4|1.8|||t-test, 2 sided|||||1.80|-0.40|0.1711
73858151|NCT05479097|147261676|SUPERIORITY|||||||0.7237||||||The a priori threshold for statistical significance was P \<0.05|McNemar|||The null hypothesis was that there was no difference in the proportion of patients with systolic blood pressure less than or equal to their personalized goal from baseline to 6 months.||||0.7237
73858152|NCT03894969|147261705|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PD is \> 0.667. The anti-PD GMC ratio is presented in this test with its 95% CI.|GMC ratio|0.942|||||TWO_SIDED|0.95|0.765|1.159|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.159|0.765|
73858153|NCT03894969|147261705|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PE is \> 0.667. The anti-PE GMC ratio is presented in this test with its 95% CI.|GMC ratio|0.887|||||TWO_SIDED|0.95|0.719|1.093|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.093|0.719|
73858154|NCT03894969|147261705|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PilA is \> 0.667. The anti-PilA GMC ratio is presented in this test with its 95% CI.|GMC ratio|1.142|||||TWO_SIDED|0.95|0.884|1.474|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.474|0.884|
73858155|NCT03894969|147261705|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-UspA2 is \> 0.667. The anti-UspA2 GMC ratio is presented in this test with its 95% CI.|GMC ratio|1.087|||||TWO_SIDED|0.95|0.948|1.245|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.245|0.948|
73858156|NCT00468676|147261719|SUPERIORITY_OR_OTHER||scaled marginal model parameter|-1.57|STANDARD_ERROR_OF_MEAN|0.28||0.001|TWO_SIDED|95.0|-2.12|-1.02||Significance of the four outcome composite|Scaled Marginal Model||Intervention group had significantly lower scaled marginal mean scores than usual care|||-1.02|-2.12|.001
73858157|NCT00468676|147261720|SUPERIORITY_OR_OTHER||Slope|0.01|||<|0.01||95.0|||||general estimating equations|||Disability outcomes were measured at six and 12 months after randomization using linear regression models adjusted for baseline values. The disability models combined information across time points and were estimated using general estimating equations to account for correlation. All analyses were based on intent to treat principles||||<0.01
73858158|NCT00468676|147261722|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.56|-0.26|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||-0.26|-0.56|<0.001
73858159|NCT00468676|147261723|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-3.4|||||TWO_SIDED|95.0|-6.9|0.1|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||0.1|-6.9|
73858160|NCT00468676|147261724|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-9.1|||||TWO_SIDED|95.0|-17.5|-0.8|||Regression, Linear||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a linear-regression model predicting a 12-month outcome.|||-0.8|-17.5|
73858161|NCT00468676|147261725|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-0.56|||||TWO_SIDED|95.0|-0.85|-0.27|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||-0.27|-0.85|
73858162|NCT00118846|147261732|SUPERIORITY||Slope|-0.91||||0.35|TWO_SIDED|95.0|-2.86|1.05|||Mixed Models Analysis||Slope = Mean difference in annualized rate of change|||1.05|-2.86|0.35
73858163|NCT00118846|147261733|OTHER||Mean Difference (Net)|0.11||||0.36|TWO_SIDED|95.0|-0.13|0.35|||ANCOVA|||||0.35|-0.13|0.36
73858164|NCT00443053|147261734|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Fisher Exact|||||0.26|0.08|<0.001
73858165|NCT00443053|147261735|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.32|||Fisher Exact|||||0.32|0.12|<0.001
73858166|NCT01574157|147261764|SUPERIORITY||Mean Difference (Final Values)|12.6|||||TWO_SIDED|95.0|-9.6|40.1||||||The primary analysis compared the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||40.1|-9.6|
73858167|NCT01574157|147261765|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-38.2|30.8||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||30.8|-38.2|
73858168|NCT01574157|147261766|SUPERIORITY||Mean Difference (Final Values)|-32.5|||||TWO_SIDED|95.0|-56.3|4.2||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||4.2|-56.3|
73931001|NCT01147653|147391742|SUPERIORITY|H0: The population distribution of the Peabody Gross Motor Quotient change score 1 year post-infusion with autologous umbilical cord blood is the same in patients receiving a Low infused dose and a High infused dose.||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73858169|NCT01574157|147261767|SUPERIORITY||Mean Difference (Final Values)|7.7|||||TWO_SIDED|95.0|-15.1|36.5||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||36.5|-15.1|
73858170|NCT01574157|147261768|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-24.6|35.9||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||35.9|-24.6|
73858171|NCT01574157|147261769|SUPERIORITY||Mean Difference (Final Values)|3.37|||||TWO_SIDED|95.0|-0.05|6.79||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||6.79|-0.05|
73858172|NCT05032690|147261783|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|99.17|||||TWO_SIDED|90.0|93.72|104.93|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||104.93|93.72|
73858173|NCT05032690|147261783|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|135.9|||||TWO_SIDED|90.0|109.28|169.01|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted."||169.01|109.28|
73858174|NCT05032690|147261784|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|93.77|||||TWO_SIDED|90.0|90.08|97.61|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||97.61|90.08|
73858175|NCT05032690|147261784|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|162.54|||||TWO_SIDED|90.0|130.25|202.84|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted"||202.84|130.25|
73858176|NCT05032690|147261785|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|98.21|||||TWO_SIDED|90.0|93.83|102.8|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||102.80|93.83|
73909829|NCT05224141|147349684|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.9762|TWO_SIDED|95.0|1.0|1.59|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, LDH, liver metastasis, and brain metastasis.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||1.59|1.00|0.9762
73909830|NCT05224141|147349685|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5316|TWO_SIDED|95.0|0.82|1.23|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, LDH, liver metastasis, and brain metastasis.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||1.23|0.82|0.5316
73909831|NCT05224141|147349686|SUPERIORITY||Percent Difference|-3.1|||||TWO_SIDED|95.0|-11.1|4.9|||||Based on Miettinen \& Nurminen method stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||4.9|-11.1|
73909832|NCT01479127|147349706|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||Paired t-test|||"TRS I OFF state"||||0.058
73909833|NCT01479127|147349706|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Paired t-test|||"TRS I Dyskinesia state"||||1.000
73909834|NCT01479127|147349706|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||Paired t-test|||"TRS II Normal state"||||0.153
73909835|NCT01479127|147349706|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Paired t-test|||"TRS II OFF state"||||0.140
73909836|NCT01479127|147349706|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Paired t-test|||"TRS II Dyskinesia state"||||0.374
73909837|NCT01479127|147349707|SUPERIORITY_OR_OTHER|||||||0.574|TWO_SIDED||||||Paired t-test|||||||0.574
73909838|NCT01479127|147349707|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED||||||Paired t-test|||ON time w/o D + time with NTD||||0.661
73909839|NCT01479127|147349707|SUPERIORITY_OR_OTHER|||||||0.574|TWO_SIDED||||||Paired t-test|||ON time w/o D + time with NTD + time w/ TD||||0.574
73909840|NCT01479127|147349708|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon one-sample test|||Rapid alternating movement of hands||||0.500
73909841|NCT01479127|147349708|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||Arising from chair||||1.000
73909842|NCT01479127|147349708|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon one-sample test|||Postural stability||||0.250
73909843|NCT01479127|147349708|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon one-sample test|||Body bradykinesia and hypokinesia||||0.500
73909844|NCT01479127|147349708|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon one-sample test|||Dyskinesia||||0.250
73909845|NCT01479127|147349709|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Paired t-test|||Total score||||0.870
73909846|NCT01479127|147349709|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Paired t-test|||Part I||||0.374
73909847|NCT01479127|147349709|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Paired t-test|||Part II||||0.799
73909848|NCT01479127|147349709|SUPERIORITY_OR_OTHER|||||||0.493|TWO_SIDED||||||Paired t-test|||Part II (Off-time)||||0.493
73909849|NCT01479127|147349709|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Paired t-test|||Part III||||0.530
73909850|NCT01479127|147349709|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||Paired t-test|||Part IV sub-score of dyskinesia||||0.108
73909851|NCT01479127|147349710|SUPERIORITY_OR_OTHER|||||||0.636|TWO_SIDED||||||Paired t-test|||Total score||||0.636
73909852|NCT01479127|147349710|SUPERIORITY_OR_OTHER|||||||0.329|TWO_SIDED||||||Paired t-test|||Domain: Mobility||||0.329
73909853|NCT01479127|147349710|SUPERIORITY_OR_OTHER|||||||0.902|TWO_SIDED||||||Paired t-test|||Domain: Activities of daily living||||0.902
73909854|NCT01479127|147349710|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Paired t-test|||Domain: Emotional well-being||||0.220
73909855|NCT01479127|147349710|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Paired t-test|||Domain: Stigma||||0.799
73909856|NCT01479127|147349710|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED||||||Paired t-test|||Domain: Social support||||0.178
73909857|NCT01479127|147349710|SUPERIORITY_OR_OTHER|||||||0.456|TWO_SIDED||||||Paired t-test|||Domain: Cognition||||0.456
73909858|NCT01479127|147349710|SUPERIORITY_OR_OTHER|||||||0.866|TWO_SIDED||||||Paired t-test|||Domain: Communication||||0.866
73909859|NCT01479127|147349710|SUPERIORITY_OR_OTHER|||||||0.576|TWO_SIDED||||||Paired t-test|||Domain: Bodily discomfort||||0.576
73909860|NCT01479127|147349711|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||"On state staging"||||1.000
73909861|NCT01479127|147349711|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||"Off state staging"||||1.000
73909862|NCT01479127|147349712|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||Wilcoxon one-sample test|||||||0.125
73909863|NCT01479127|147349717|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||Paired t-test|||||||0.074
73909864|NCT03469934|147349732|OTHER||Least Squares (LS) Mean Difference|-0.058||||0.5703|TWO_SIDED|95.0|-0.265|0.15|||Mixed-model repeated measures|||Mixed-model repeated measures (MMRM) analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.||0.150|-0.265|0.5703
73909865|NCT03469934|147349736|OTHER||LS Mean Difference|-0.05||||0.5901|TWO_SIDED|95.0|-0.239|0.139|||Mixed-model repeated measures|||MMRM analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.||0.139|-0.239|0.5901
73909866|NCT03469934|147349737|OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.164||0.596|TWO_SIDED|95.0|-0.25|0.43|||ANCOVA|||Change from baseline for FEV1 was compared between etokimab and placebo using an analysis of covariance (ANCOVA) with treatment as fixed effect and baseline result as covariate and participant as a random effect||0.43|-0.25|0.5960
73909867|NCT03469934|147349738|OTHER||LS Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|9.823||0.7993|TWO_SIDED|95.0|-17.9|22.96|||ANCOVA|||Change from baseline for FeNO was compared between etokimab and placebo using an ANCOVA with treatment as fixed effect and baseline result as covariate and participant as a random effect||22.96|-17.90|0.7993
73909868|NCT00914485|147349749|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 1 sided|||Increase in mean, post-intervention versus baseline, across 18 providers and 369 patients.||||.03
73909869|NCT04889222|147349751|EQUIVALENCE|A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the INVSENSOR00050 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.||||||0.00097||||||The a priori threshold for p-value was 0.05.|Two One Sided Tests (TOST)|||||||0.00097
73909870|NCT04889222|147349752|EQUIVALENCE|A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the RD SET SpO2 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.||||||0||||||The a priori threshold for p-value was 0.05.|Two One-Sided Tests (TOST)|||||||0.00000
73909871|NCT04873700|147349755|SUPERIORITY||||||=|0.0701|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Location of disease||||=0.0701
73909872|NCT04873700|147349755|SUPERIORITY||||||=|0.1383|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Disease behavior||||=0.1383
73909873|NCT04873700|147349755|SUPERIORITY||||||=|0.0478|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Perianal disease||||=0.0478
73909874|NCT04873700|147349755|SUPERIORITY||||||=|0.1454|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Ileal disease||||=0.1454
73909875|NCT04873700|147349755|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Peripheral arthritis||||=1.0000
73909876|NCT04873700|147349755|SUPERIORITY||||||=|0.4992|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Aphthous ulcers||||=0.4992
73909877|NCT04873700|147349755|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Episcleritis||||=1.0000
73909878|NCT04873700|147349755|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Uveitis||||=1.0000
74088503|NCT03923699|147730409|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.95|1.05||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.05|0.95|0.95
73909879|NCT04873700|147349755|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Osteoporosis||||=1.0000
73909880|NCT04873700|147349755|SUPERIORITY||||||=|0.2022|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Anemia||||=0.2022
73909881|NCT04873700|147349755|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Hematological alteration||||=1.0000
73909882|NCT04873700|147349755|SUPERIORITY||||||=|0|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Other||||=0.0000
73909883|NCT04873700|147349756|SUPERIORITY||||||=|0.2896|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Location of disease||||=0.2896
73909884|NCT04873700|147349756|SUPERIORITY||||||=|0.0006|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Disease behavior||||=0.0006
73909885|NCT04873700|147349756|SUPERIORITY||||||=|0.089|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Peripheral arthritis||||=0.0890
73909886|NCT04873700|147349756|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Pyoderma gangrenosum||||=1.0000
73909887|NCT04873700|147349756|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Aphthous ulcers||||=1.0000
73909888|NCT04873700|147349756|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Primary sclerosing cholangitis||||=1.0000
73909889|NCT04873700|147349756|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Osteoporosis||||=1.0000
73909890|NCT04873700|147349756|SUPERIORITY||||||=|0.0752|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Anemia||||=0.0752
73909891|NCT04873700|147349756|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Hematological alteration||||=1.0000
73909892|NCT04873700|147349756|SUPERIORITY||||||=|0.1032|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Other||||=0.1032
73909893|NCT00113087|147349796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.28|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.28
73909894|NCT00113087|147349797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.42||95.0|||||Mixed Models Analysis|||||||0.42
73909895|NCT00113087|147349798|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64||||0.008||95.0|||||Mixed Models Analysis|||||||0.008
73909896|NCT00113087|147349799|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
73909897|NCT00113087|147349800|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Fisher Exact|||||||0.71
73909898|NCT00113087|147349801|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.74
73909899|NCT00113087|147349802|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.22
73909900|NCT00113087|147349803|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||||||0.86
73909901|NCT00113087|147349804|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
73909902|NCT00113087|147349805|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
73909903|NCT00113087|147349806|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
73909904|NCT00113087|147349807|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
73909905|NCT00113087|147349808|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
73909906|NCT00113087|147349809|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
73909907|NCT00113087|147349810|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
73909908|NCT00113087|147349811|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||t-test, 2 sided|||||||0.37
73909909|NCT00113087|147349812|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
73909910|NCT00113087|147349813|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
73909911|NCT00113087|147349814|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
73909912|NCT00113087|147349815|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
73909913|NCT00113087|147349816|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.49
73909914|NCT00113087|147349817|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||t-test, 2 sided|||||||0.35
73909915|NCT00113087|147349818|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||||||0.62
73909916|NCT00113087|147349819|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
73909917|NCT00113087|147349820|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
73909918|NCT00113087|147349821|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||t-test, 2 sided|||||||0.34
73909919|NCT00113087|147349822|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||||||.81
73909920|NCT00113087|147349823|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Fisher Exact|||||||0.08
73909921|NCT00113087|147349824|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||||||0.06
73909922|NCT03685123|147349875|SUPERIORITY|||||||0.256|||||||Mixed Models Analysis|||||||0.256
73909923|NCT03685123|147349876|SUPERIORITY|||||||0.089|||||||Mixed Models Analysis|||||||0.089
73909924|NCT03685123|147349877|SUPERIORITY|||||||0.244|||||||Mixed Models Analysis|||||||0.244
73909925|NCT03685123|147349878|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||0.064
73909926|NCT03685123|147349879|SUPERIORITY|||||||0.983|||||||Mixed Models Analysis|||LDL levels||||0.983
73909927|NCT03685123|147349879|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||HDL levels||||0.56
73909928|NCT03685123|147349879|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Total Cholesterol||||0.71
74088504|NCT03923699|147730410|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.29|TWO_SIDED|95.0|0.0|0.0||Not adjusted for multiple comparisons.|Regression, Linear|||||0.00|-0.00|0.29
74088505|NCT03923699|147730411|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.37|TWO_SIDED|95.0|-0.01|0.0||Not adjusted for multiple comparisons.|Regression, Linear|||||0.00|-0.01|0.37
73909929|NCT03685123|147349879|SUPERIORITY|||||||0.313|||||||Mixed Models Analysis|||Triglycerides||||0.313
73909930|NCT03685123|147349880|SUPERIORITY|||||||0.72|||||||Mixed Models Analysis|||systolic Blood pressure||||0.72
73909931|NCT03685123|147349880|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||Diastolic Blood pressure||||0.61
73909932|NCT03685123|147349880|SUPERIORITY|||||||0.1609|||||||Mixed Models Analysis|||Change in aortic blood pressure between the PA-REC and the WM-REC Groups.||||0.1609
73909933|NCT03685123|147349880|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||Change in aortic diastolic blood pressure between the PA-REC and WM-REC Groups||||0.446
73909934|NCT03685123|147349881|SUPERIORITY|||||||0.965|||||||Mixed Models Analysis|||||||0.965
73909935|NCT03685123|147349882|SUPERIORITY|||||||0.857|||||||Mixed Models Analysis|||||||0.857
73909936|NCT03685123|147349883|SUPERIORITY|||||||0.825|||||||Mixed Models Analysis|||||||0.825
73909937|NCT03685123|147349884|SUPERIORITY|||||||0.061|||||||Mixed Models Analysis|||||||0.061
73909938|NCT03685123|147349886|SUPERIORITY|Change in particle size between the PA-REC and WM-REC groups||||||0.105|||||||Mixed Models Analysis|||Change in HDL particle size||||0.105
73964841|NCT02652260|147465379|OTHER||Estimated Difference|3.6|||||TWO_SIDED|95.0|-4.1|11.3||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.|11.3|-4.1|
73964842|NCT02652260|147465380|OTHER|The 95% CI was calculated by the method of Miettinen and Nurminen.|Difference in Percentage|-38.4|||||TWO_SIDED|95.0|-51.2|-23.8||||||Change from time of switch to 24 weeks post-switch: Treatment difference in percent response|Week 24 Post-switch minus Time of switch|-23.8|-51.2|
73964843|NCT02652260|147465381|OTHER|The 95% CI was based on a t-distribution.|Mean Difference (Final Values)|-13.4|||||TWO_SIDED|95.0|-16.8|-10.1||||||Change from time of switch to 24 weeks post-switch: Treatment difference in score|Week 24 Post-switch minus Time of switch|-10.1|-16.8|
73964844|NCT02652260|147465382|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-9.02|||||TWO_SIDED|95.0|-15.69|-2.35||||||Difference Estimate: LDL Cholesterol|ISG minus DSG|-2.35|-15.69|
73964845|NCT02652260|147465382|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-13.57|||||TWO_SIDED|95.0|-20.79|-6.35||||||Difference Estimate: Non-HDL Cholesterol|ISG minus DSG|-6.35|-20.79|
73964846|NCT02652260|147465382|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-21.42|||||TWO_SIDED|95.0|-29.63|-13.21||||||Difference Estimate: Cholesterol|ISG minus DSG|-13.21|-29.63|
73964847|NCT02652260|147465382|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-8.18|||||TWO_SIDED|95.0|-11.76|-4.6||||||Difference Estimate: HDL Cholesterol|ISG minus DSG|-4.60|-11.76|
73964848|NCT02652260|147465382|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-22.18|||||TWO_SIDED|95.0|-38.52|-5.84||||||Difference Estimate: Triglyceride|ISG minus DSG|-5.84|-38.52|
73909939|NCT03685123|147349886|SUPERIORITY|Change in particle size between the PA-REC and the WM-REC groups||||||0.849|||||||Mixed Models Analysis|||Change in LDL particles||||0.849
73909940|NCT03685123|147349888|SUPERIORITY|||||||0.278|||||||ANOVA|||Change in steps per day from week 10 to week 28||||0.278
73909941|NCT03685123|147349889|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||Change in SF-36 General Health (GH)||||0.238
73909942|NCT03685123|147349889|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.124|||||||Mixed Models Analysis|||Change in SF-36 Physical health (PH)||||0.124
73909943|NCT03685123|147349889|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.769|||||||Mixed Models Analysis|||Change in SF-36 role physical||||0.769
73909944|NCT03685123|147349889|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.352|||||||Mixed Models Analysis|||Change in SF-36 Bodily Pain||||0.352
73909945|NCT03685123|147349889|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.898|||||||Mixed Models Analysis|||Change in SF-36 Vitality||||0.898
73909946|NCT03685123|147349889|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.444|||||||Mixed Models Analysis|||Change in SF-36 social function||||0.444
73909947|NCT03685123|147349889|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.537|||||||Mixed Models Analysis|||Change in SF-36 Mental Health||||0.537
73909948|NCT03685123|147349889|SUPERIORITY|||||||0.448|||||||Mixed Models Analysis|||Change in SF-36 Role Emotional||||0.448
73909949|NCT03685123|147349889|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.537|||||||Mixed Models Analysis|||Change in SF-36 Mental Health (Sum)||||0.537
73909950|NCT03685123|147349889|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.482|||||||Mixed Models Analysis|||Change in SF-36 Physical Health (sum)||||0.482
73909951|NCT03685123|147349891|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73909952|NCT03685123|147349892|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.37
73909953|NCT03685123|147349893|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in body fat||||<0.001
73909954|NCT03685123|147349894|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73909955|NCT03685123|147349895|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||LDL||||0.004
73909956|NCT03685123|147349895|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Change in HDL||||0.04
73909957|NCT03685123|147349895|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in Total Cholesterol||||<0.001
73964849|NCT04714320|147465410|SUPERIORITY||||||=|0.135||||||The stratification factor (screening estimated glomerular filtration rate (eGFR) status \[\<60 vs. ≥60 mL/min/1.73 m\^2\]), treatment received, and baseline measure were included in the analysis of covariate (ANCOVA) model as independent variables.|ANCOVA|||Change From Baseline in Seated Automated Office SBP to Day 85||||=0.135
74088506|NCT03923699|147730412|SUPERIORITY||Risk Ratio (RR)|1.03||||0.3|TWO_SIDED|95.0|0.95|1.13||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.13|0.95|0.30
73909958|NCT03685123|147349895|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Triglycerides||||<0.001
73909959|NCT03685123|147349896|SUPERIORITY|||||||0.01||||||Systolic blood pressure|Mixed Models Analysis|||||||0.01
73909960|NCT03685123|147349896|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||Diastolic blood pressure||||0.001
73909961|NCT03685123|147349896|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Aortic blood pressure (mmHg)||||<0.001
73909962|NCT03685123|147349896|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in aortic diastolic pressure||||<0.001
73909963|NCT03685123|147349897|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73909964|NCT03685123|147349898|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73909965|NCT03685123|147349899|SUPERIORITY|||||||0.366|||||||Mixed Models Analysis|||||||0.366
73909966|NCT03685123|147349900|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73909967|NCT03685123|147349902|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
73909968|NCT03685123|147349903|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73909969|NCT03685123|147349904|SUPERIORITY||||||<|0.001||||||General Health|Mixed Models Analysis|||||||<0.001
73909970|NCT03685123|147349904|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Physical Health||||<0.001
73909971|NCT03685123|147349904|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||Role physical||||0.023
73909972|NCT03685123|147349904|SUPERIORITY||||||<|0.001||||||Bodily Pain|Mixed Models Analysis|||||||<0.001
73909973|NCT03685123|147349904|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Vitality||||<0.001
73909974|NCT03685123|147349904|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Social Functioning||||<0.001
73909975|NCT03685123|147349904|SUPERIORITY|||||||0.0105|||||||Mixed Models Analysis|||Mental Health||||0.0105
73909976|NCT03685123|147349904|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Role Emotional||||<0.001
73909977|NCT03685123|147349904|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||SF-36 mental health Components (sum)||||0.01
73909978|NCT03685123|147349904|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Physical Health Components Sum||||<0.001
73909979|NCT03685123|147349905|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in kilocalories consumed from baseline to week 10||||<0.001
73909980|NCT03685123|147349906|SUPERIORITY|||||||0.658|||||||Mixed Models Analysis|||Change in LDL Particle Size||||0.658
73909981|NCT03685123|147349906|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||HDL participle size||||0.07
73909982|NCT02628938|147349919|SUPERIORITY_OR_OTHER|||||||0.299|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak extract mouth wash||||0.299
73909983|NCT02628938|147349919|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak extract mouth wash||||0.007
73909984|NCT02628938|147349919|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak sticks||||0.019
73909985|NCT02628938|147349919|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak sticks||||0.000
73909986|NCT02628938|147349919|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash||||0.000
73909987|NCT02628938|147349919|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.001
73909988|NCT02628938|147349920|SUPERIORITY_OR_OTHER|||||||0.496|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak extract mouth wash||||0.496
73909989|NCT02628938|147349920|SUPERIORITY_OR_OTHER|||||||0.244|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Miswak extract mouth wash||||0.244
73909990|NCT02628938|147349920|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak sticks||||0.19
73909991|NCT02628938|147349920|SUPERIORITY_OR_OTHER|||||||0.829|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of of using Miswak sticks||||0.829
73909992|NCT02628938|147349920|SUPERIORITY_OR_OTHER|||||||0.341|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash||||0.341
73909993|NCT02628938|147349920|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.82
73909994|NCT02628938|147349921|SUPERIORITY_OR_OTHER|||||||0.008|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak extract mouth wash||||0.008
73909995|NCT02628938|147349921|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak sticks||||0.001
73909996|NCT02628938|147349921|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.02
73909997|NCT03113916|147349922|SUPERIORITY||Slope|2.63|||=|0.001|TWO_SIDED|95.0|1.05|4.2|||Mixed Models Analysis|||||4.20|1.05|=.001
73909998|NCT03113916|147349923|SUPERIORITY||Slope|-0.49||||0.23|TWO_SIDED|95.0|-1.29|0.31|||Mixed Models Analysis|||||0.31|-1.29|.23
73909999|NCT03113916|147349924|SUPERIORITY||Slope|0.000000676||||0.06|TWO_SIDED|95.0|-0.00000002|0.00000137|||Mixed Models Analysis|||||.00000137|-.00000002|.06
73910000|NCT03113916|147349925|SUPERIORITY||Slope|-5.64||||0.29|TWO_SIDED|95.0|-16.0|4.73|||Mixed Models Analysis||Values given need to be multiplied by 10 to the power of -10 (i.e., x 10\^-10).|||4.73|-16|.29
73910001|NCT03113916|147349926|SUPERIORITY||Slope|0.351||||0.27|TWO_SIDED|95.0|-0.277|0.978|||Mixed Models Analysis|||||.978|-.277|.27
73910002|NCT03113916|147349927|SUPERIORITY||Slope|-0.015||||0.1|TWO_SIDED|95.0|-0.032|0.003|||Mixed Models Analysis|||||.003|-.032|.10
73910003|NCT03113916|147349928|SUPERIORITY||Slope|-11.2||||0.07|TWO_SIDED|95.0|-23.0|0.7|||Mixed Models Analysis|||||0.7|-23.0|.07
73910004|NCT03113916|147349929|SUPERIORITY||Slope|-0.63||||0.12|TWO_SIDED|95.0|-1.41|0.16|||Mixed Models Analysis|||||0.16|-1.41|.12
73910005|NCT03113916|147349930|SUPERIORITY||Slope|0.174||||0.008|TWO_SIDED|95.0|0.05|0.302|||Mixed Models Analysis|||||.302|.050|.008
73910006|NCT03113916|147349931|SUPERIORITY||Slope|0.015||||0.5|TWO_SIDED|95.0|-0.029|0.059|||Mixed Models Analysis|||||.059|-.029|.50
73910007|NCT03113916|147349932|SUPERIORITY||Slope|-0.00003||||0.99|TWO_SIDED|95.0|-0.013|0.013|||Mixed Models Analysis|||||.013|-.013|.99
74026536|NCT01933672|147606472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|80.0|-0.55|0.51||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.51|-0.55|
74026537|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|||||TWO_SIDED|80.0|-0.75|1.07||||||Compared with Baseline （Pre-breakfast）||1.07|-0.75|
74026538|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46|||||TWO_SIDED|80.0|-0.58|1.51||||||Compared with Baseline (Pre-breakfast)||1.51|-0.58|
74026539|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|80.0|0.58|2.63||||||Compared with Baseline (Pre-breakfast)||2.63|0.58|
74026540|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|||||TWO_SIDED|80.0|-2.84|-0.05||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.05|-2.84|
74085343|NCT03566238|147724396|SUPERIORITY|"ANCOVA model including treatment, baseline pruritus score at AM and PM, PFIC type, and age category was used for treatment comparisons. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."|LS mean difference|28.23|STANDARD_ERROR_OF_MEAN|9.182||0.0019|TWO_SIDED|95.0|9.83|46.64|||ANCOVA|||Analysis of the Proportion of Positive Pruritus Assessments at Participant Level over the 24-Week Treatment Period - Albireo ObsRO Instrument (AM and PM Scores)||46.64|9.83|0.0019
74088507|NCT03923699|147730413|SUPERIORITY||Risk Ratio (RR)|1.0||||0.85|TWO_SIDED|95.0|0.98|1.02||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.02|0.98|0.85
73910008|NCT00370071|147349935|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||In this single arm study, the number of newly active lesions per 3 months during treatment was compared to the number of newly active lesions during 3-month pre-treatment (Alternative hypothesis: Number of lesions is reduced during treatment with Interferon beta-1b). The sample size was calculated for the use of the one-sided Wilcoxon-Signed-Rank test at level 2.5% (Power of 90% - anticipating P(X\&lt;Y)=0.15 and allowing for 25% exclusion from Per Protocol Set).||||<0.0001
73910009|NCT00370071|147349936|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||||||<0.0001
73910010|NCT00370071|147349937|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||||||0.0017
73910011|NCT00370071|147349938|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon-Signed-Rank test|One-sided p-value from Wilcoxon-Signed-Rank-Test for comparing the baseline visit to treatment visits||Lesion volume at Week 12. 38 subjects were evaluated.||||<0.0001
74088508|NCT03923699|147730414|SUPERIORITY||Risk Ratio (RR)|0.99||||0.51|TWO_SIDED|95.0|0.97|1.02||Not adjusted for multiple comparisons.|Regression, poisson|||||1.02|0.97|0.51
73910012|NCT00370071|147349938|SUPERIORITY_OR_OTHER||||||=|0.0019|||||||Wilcoxon-Signed-Rank test|||Lesion volume at Week 24. 37 subjects were evaluated.||||=0.0019
73910013|NCT01999868|147349959|SUPERIORITY|||||||0.41||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study. This analysis is the primary analysis of the primary endpoint.||||0.41
73910014|NCT01999868|147349959|SUPERIORITY|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.013
73931002|NCT01147653|147391743|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.04|TWO_SIDED|95.0|0.01|0.38|||Wilcoxon (Mann-Whitney)|||H0: The true mean 1-year change in normalized whole brain connectivity is the same in patients infused with Low and High doses of autologous umbilical cord blood.||0.38|0.01|0.04
73931003|NCT01302392|147391755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.4172|TWO_SIDED|95.0|0.76|1.249||Based on 1-sided test.|Log Rank|Analysis was stratified by the number of previous therapies (3 vs 4 vs ≥ 5) and geographical region (Europe vs. non-Europe)||||1.249|0.760|0.4172
73931004|NCT01702233|147391773|NON_INFERIORITY_OR_EQUIVALENCE|All statistical analyses were of exploratory nature. A one-sided test of non-inferiority of Traumeel®S with respect to dexamethasone at level 0.025 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the baseline value of the abduction rotation pain VAS for active external rotation as a covariate. The test decision was based on a one-sided 97.5% confidence interval . The non-inferiority margin was set to 13 mm on a 0-100 mm VAS scale.|Mean Difference (Final Values)|13.0|STANDARD_DEVIATION|13.0|<|0.05|ONE_SIDED|95.0||97.5|||ANCOVA|||||97.5||<0.05
73931005|NCT01813019|147391792|SUPERIORITY_OR_OTHER|||||||0.671|||||||Mixed Models Analysis|||||||0.671
73931006|NCT01559311|147391794|SUPERIORITY_OR_OTHER|||||||0.1734|||||||Wilcoxon (Mann-Whitney)|||"* H01: μ LVEF, 1= μ LVEF, 2a vs H1a: μ LVEF, 1 \< μ LVEF, 2a~* Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~* μ LVEF, 2a is the mean of LVEF at month 12 in CRT-P ON Gp,"||||0.1734
73931007|NCT01559311|147391794|SUPERIORITY_OR_OTHER|||||||0.1439|||||||Wilcoxon (Mann-Whitney)|||"* H03: μ LVEF, 1= μ LVEF, 2b vs H1a: μ LVEF, 1 \< μ LVEF, 2b~* Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~* μ LVEF, 2b is the mean of LVEF at month 12 in the CRT-P OFF Gp"||||0.1439
73910015|NCT01999868|147349959|SUPERIORITY|||||||0.5||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.50
73910016|NCT01999868|147349959|SUPERIORITY|||||||0.67||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.67
74088509|NCT01746264|147730415|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||P-value for change from baseline to 3 month follow-up.||||0.59
73910017|NCT01999868|147349960|SUPERIORITY|||||||0.019||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.019
73910018|NCT01999868|147349960|SUPERIORITY|||||||0.001||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.001
73910019|NCT01999868|147349960|SUPERIORITY|||||||0.018||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.018
73910020|NCT01999868|147349960|SUPERIORITY|||||||0.07||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.07
73910021|NCT01999868|147349961|SUPERIORITY|||||||0.16||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.16
73910022|NCT01999868|147349961|SUPERIORITY|||||||0.002||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.002
73910023|NCT01999868|147349961|SUPERIORITY|||||||0.23||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.23
73910024|NCT01999868|147349961|SUPERIORITY|||||||0.43||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.43
73910025|NCT01999868|147349962|SUPERIORITY|||||||0.06||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.06
73910026|NCT01999868|147349962|SUPERIORITY|||||||0.008||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.008
73910027|NCT01999868|147349963|SUPERIORITY|||||||0.005||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.005
73910028|NCT01999868|147349963|SUPERIORITY|||||||0.001||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.001
73910029|NCT01999868|147349964|SUPERIORITY|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40||||0.013
73910030|NCT01999868|147349964|SUPERIORITY|||||||0.95|||||||Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 88||||0.95
73910031|NCT01999868|147349965|SUPERIORITY|||||||0.18||||||Two-sided test.|ANCOVA|Randomization stratum (PASI score at week 0: 12-20 or \>20), baseline DLQI, and pre-screening disease duration, centered on the median, are covariates.||Week 12 to 40||||0.18
73910032|NCT01999868|147349965|SUPERIORITY|||||||0.045||||||Two-sided test.|ANCOVA|Randomization (PASI score week 0:12-20 or \>20), DLQI score at baseline, duration of disease prior to screening, centered about median, are covariates||Week 12 to 88||||0.045
73910033|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|1.24|1.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.80|1.24|
73910034|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.15||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.15|0.78|
74088510|NCT01746264|147730416|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow up visit.||||<0.001
74088511|NCT01746264|147730417|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||<0.01
73910035|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.8|1.12||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.12|0.80|
73910036|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.19|1.76||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.76|1.19|
73910037|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.86|0.59|
73910038|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|1.15|1.86||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.86|1.15|
73910039|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.97|1.42||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.42|0.97|
73910040|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|1.36|2.13||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||2.13|1.36|
73910041|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||TWO_SIDED|95.0|0.48|0.67||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.67|0.48|
73910042|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.53|0.89||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.89|0.53|
73910043|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|1.05|1.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.67|1.05|
73910044|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||TWO_SIDED|95.0|0.53|0.76||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.76|0.53|
73910045|NCT00761631|147349973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.91|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.28|0.91|
73910046|NCT00502944|147349978|SUPERIORITY_OR_OTHER||Rate Difference (%)|30.0|||<|0.001|TWO_SIDED|95.0|27.0|32.0|||Chi-squared|||HIV test completed among patients randomized||32|27|<0.001
73910047|NCT00502944|147349979|SUPERIORITY_OR_OTHER||Rate Difference (%)|44.0|||<|0.001|TWO_SIDED|95.0|42.0|47.0|||Chi-squared|||HIV test offered||47|42|<0.001
73910048|NCT00502944|147349980|SUPERIORITY_OR_OTHER||Rate Difference (%)|-4.0||||0.02|TWO_SIDED|95.0|-8.0|-1.0|||Chi-squared|||HIV test accepted among patients offered||-1|-8|0.02
73910049|NCT03572972|147349988|SUPERIORITY||Hazard Ratio (HR)|0.618|||||TWO_SIDED|95.0|0.541|0.707||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of hazard ratio (HR) at year 1 as an extended Cox model was used.||0.707|0.541|
73910050|NCT03572972|147349988|SUPERIORITY||Hazard Ratio (HR)|0.604|||||TWO_SIDED|95.0|0.53|0.687||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.687|0.530|
73910051|NCT03572972|147349988|SUPERIORITY||Hazard Ratio (HR)|0.705|||||TWO_SIDED|95.0|0.563|0.884|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.884|0.563|
74088512|NCT01746264|147730419|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.32
74088513|NCT01746264|147730420|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3-month follow-up.||||0.21
74026541|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.14|||||TWO_SIDED|80.0|-2.63|0.35||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.35|-2.63|
73910052|NCT03572972|147349989|SUPERIORITY||Hazard Ratio (HR)|0.993|||||TWO_SIDED|95.0|0.87|1.134||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.134|0.870|
73910053|NCT03572972|147349989|SUPERIORITY||Hazard Ratio (HR)|0.949|||||TWO_SIDED|95.0|0.839|1.073||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.073|0.839|
73910054|NCT03572972|147349989|SUPERIORITY||Hazard Ratio (HR)|0.961|||||TWO_SIDED|95.0|0.854|1.082||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.082|0.854|
73910055|NCT03572972|147349990|SUPERIORITY||Hazard Ratio (HR)|0.583|||||TWO_SIDED|95.0|0.512|0.664||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.664|0.512|
73910056|NCT03572972|147349990|SUPERIORITY||Hazard Ratio (HR)|0.754|||||TWO_SIDED|95.0|0.597|0.953|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.953|0.597|
73910057|NCT03572972|147349990|SUPERIORITY||Hazard Ratio (HR)|0.844|||||TWO_SIDED|95.0|0.685|1.04|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.040|0.685|
74088514|NCT01746264|147730421|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.02
73910058|NCT03572972|147349991|SUPERIORITY||Hazard Ratio (HR)|0.866|||||TWO_SIDED|95.0|0.761|0.985||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.985|0.761|
73910059|NCT03572972|147349991|SUPERIORITY||Hazard Ratio (HR)|0.768|||||TWO_SIDED|95.0|0.684|0.862||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.862|0.684|
73910060|NCT03572972|147349991|SUPERIORITY||Hazard Ratio (HR)|0.875|||||TWO_SIDED|95.0|0.786|0.975||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.975|0.786|
73910061|NCT03572972|147349992|SUPERIORITY||Hazard Ratio (HR)|0.673|||||TWO_SIDED|95.0|0.47|0.964||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.964|0.470|
73910062|NCT03572972|147349992|SUPERIORITY||Hazard Ratio (HR)|0.491|||||TWO_SIDED|95.0|0.337|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.715|0.337|
74026542|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|||||TWO_SIDED|80.0|-0.5|3.88||||||Compared with Baseline (Pre-lunch)||3.88|-0.50|
74026543|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.07|||||TWO_SIDED|80.0|1.56|6.58||||||Compared with Baseline (Pre-lunch)||6.58|1.56|
74088515|NCT01746264|147730422|SUPERIORITY_OR_OTHER|||||||0.0123|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.0123
74026544|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|80.0|-2.42|2.4||||||Compared with Baseline (Pre-lunch)||2.40|-2.42|
74088516|NCT01746264|147730423|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.09
73910063|NCT03572972|147349992|SUPERIORITY||Hazard Ratio (HR)|0.747|||||TWO_SIDED|95.0|0.548|1.018||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.018|0.548|
73910064|NCT03572972|147349993|SUPERIORITY||Hazard Ratio (HR)|1.463|||||TWO_SIDED|95.0|0.998|2.145||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||2.145|0.998|
73910065|NCT03572972|147349993|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.647|1.225||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.225|0.647|
73910066|NCT03572972|147349993|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.447|0.888||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.888|0.447|
73910067|NCT03572972|147349994|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.556|0.738||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.738|0.556|
73910068|NCT03572972|147349994|SUPERIORITY||Hazard Ratio (HR)|0.624|||||TWO_SIDED|95.0|0.544|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.715|0.544|
73910069|NCT03572972|147349994|SUPERIORITY||Hazard Ratio (HR)|0.749|||||TWO_SIDED|95.0|0.588|0.954|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.954|0.588|
73910070|NCT03572972|147349995|SUPERIORITY||Hazard Ratio (HR)|0.977|||||TWO_SIDED|95.0|0.85|1.122||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.122|0.850|
73910071|NCT03572972|147349995|SUPERIORITY||Hazard Ratio (HR)|0.966|||||TWO_SIDED|95.0|0.848|1.1||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.100|0.848|
73910072|NCT03572972|147349995|SUPERIORITY||Hazard Ratio (HR)|0.993|||||TWO_SIDED|95.0|0.877|1.125||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.125|0.877|
73910073|NCT03572972|147349996|SUPERIORITY||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.119|0.523||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.523|0.119|
74026545|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|80.0|-1.62|5.01||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||5.01|-1.62|
74088517|NCT01746264|147730424|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.27
74088518|NCT01746264|147730425|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.18
73910074|NCT03572972|147349996|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.203|0.711||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.711|0.203|
73910075|NCT03572972|147349996|SUPERIORITY||Hazard Ratio (HR)|0.422|||||TWO_SIDED|95.0|0.247|0.722||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.722|0.247|
73910076|NCT03572972|147349997|SUPERIORITY||Hazard Ratio (HR)|0.745|||||TWO_SIDED|95.0|0.343|1.615||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.615|0.343|
73910077|NCT03572972|147349997|SUPERIORITY||Hazard Ratio (HR)|0.692|||||TWO_SIDED|95.0|0.342|1.402||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.402|0.342|
73910078|NCT03572972|147349997|SUPERIORITY||Hazard Ratio (HR)|0.932|||||TWO_SIDED|95.0|0.498|1.747||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.747|0.498|
73910079|NCT03572972|147349998|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.492|0.731||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.731|0.492|
73910080|NCT03572972|147349998|SUPERIORITY||Hazard Ratio (HR)|1.046|||||TWO_SIDED|95.0|0.719|1.522|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.522|0.719|
73910081|NCT03572972|147349998|SUPERIORITY||Hazard Ratio (HR)|1.295|||||TWO_SIDED|95.0|0.92|1.824|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.824|0.920|
73910082|NCT03572972|147349999|SUPERIORITY||Hazard Ratio (HR)|0.751|||||TWO_SIDED|95.0|0.62|0.91||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.91|0.62|
73910083|NCT03572972|147349999|SUPERIORITY||Hazard Ratio (HR)|0.697|||||TWO_SIDED|95.0|0.586|0.83||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.830|0.586|
73910084|NCT03572972|147349999|SUPERIORITY||Hazard Ratio (HR)|0.936|||||TWO_SIDED|95.0|0.801|1.094||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.094|0.801|
73964850|NCT04714320|147465410|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in Seated Automated Office SBP to Day 85||||=0.867
73964851|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline at Day 15||||<0.001
74088519|NCT01746264|147730426|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.33
74088520|NCT01746264|147730427|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.05
74088521|NCT01746264|147730428|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.41
73910085|NCT03572972|147350000|SUPERIORITY||Hazard Ratio (HR)|0.373|||||TWO_SIDED|95.0|0.212|0.658|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.658|0.212|
73910086|NCT03572972|147350000|SUPERIORITY||Hazard Ratio (HR)|0.538|||||TWO_SIDED|95.0|0.392|0.737||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.737|0.392|
73910087|NCT03572972|147350000|SUPERIORITY||Hazard Ratio (HR)|0.664|||||TWO_SIDED|95.0|0.507|0.87||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.870|0.507|
73910088|NCT03572972|147350001|SUPERIORITY||Hazard Ratio (HR)|1.204|||||TWO_SIDED|95.0|0.871|1.666||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.666|0.871|
73910089|NCT03572972|147350001|SUPERIORITY||Hazard Ratio (HR)|0.918|||||TWO_SIDED|95.0|0.691|1.218||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.218|0.691|
73910090|NCT03572972|147350001|SUPERIORITY||Hazard Ratio (HR)|0.771|||||TWO_SIDED|95.0|0.578|1.027||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.027|0.578|
73910091|NCT03572972|147350002|SUPERIORITY||Hazard Ratio (HR)|0.581|||||TWO_SIDED|95.0|0.481|0.701||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.701|0.481|
73910092|NCT03572972|147350002|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.534|0.766||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.766|0.534|
73910093|NCT03572972|147350002|SUPERIORITY||Hazard Ratio (HR)|0.838|||||TWO_SIDED|95.0|0.622|1.13|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.130|0.622|
73910094|NCT03572972|147350003|SUPERIORITY||Hazard Ratio (HR)|0.881|||||TWO_SIDED|95.0|0.732|1.061||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.061|0.732|
73910095|NCT03572972|147350003|SUPERIORITY||Hazard Ratio (HR)|0.802|||||TWO_SIDED|95.0|0.678|0.947||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.947|0.678|
73910096|NCT03572972|147350003|SUPERIORITY||Hazard Ratio (HR)|0.882|||||TWO_SIDED|95.0|0.754|1.032||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.032|0.754|
73931008|NCT01559311|147391795|SUPERIORITY_OR_OTHER|||||||0.6276|||||||Wilcoxon (Mann-Whitney)|||"* H02: μ LVESV, 1 = μ LVESV, 2a vs H1b: μ LVESV, 1 \> μ LVESV, 2a~* Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~* μLVESV, 2a is the mean of LVESV at month 12 in the CRT-P ON group"||||0.6276
73931009|NCT01559311|147391795|SUPERIORITY_OR_OTHER|||||||0.5871|||||||Wilcoxon (Mann-Whitney)|||"* H04: μ LVESV, 1 = μ LVESV, 2b vs H1b: μ LVESV, 1 \> μ LVESV, 2b~* Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~* and μLVESV, 2b is the mean of LVESV at month 12 in CRT-P OFF group."||||0.5871
73910097|NCT02569671|147350030|NON_INFERIORITY|"is less than the non-inferiority margin (indicating non-inferior bone gain).~The hypotheses associated with the primary analysis are defined as:~H0: µc - µs ≥ δ H1: µc - µs \< δ where µc is the mean change in crestal bone levels from implant loading to 12 months post-implant loading for the treatment group, µs is the mean change for the control group, and δ is the 0.5 mm non-inferiority margin. The hypotheses will be tested using a one-sided t-test with a 5% significance level."|Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.5||0.95|ONE_SIDED|95.0||||SD for both test and control group is 0.5 mm, A difference between groups of ≥ 0.5 mm is considered clinically significant, The difference between the treatment groups is expected to be 0 mm, Statistical test will be one-sided 5% significance level.|t-test, 1 sided|The hypotheses will be tested using a one-sided t-test with a 5% significance level.|The hypotheses will be tested using a one-sided t-test with a 5% significance level.|The null hypothesis for the primary analysis is that the difference between the mean change in crestal bone levels for the treatment and control groups is at least the non-inferiority margin (indicating inferior bone gain). Rejection of the null hypothesis indicates the observed data supports the alternative hypothesis that the difference between the mean change in crestal bone levels for the treatment and control groups|The change in mean bone level from implant loading to 12-month follow-up was calculated. Change in crestal bone levels was calculated as the crestal bone level at 12-months post implant loading minus crestal bone level at implant loading.|||.950
73910098|NCT02569671|147350032|NON_INFERIORITY|Smaller bone dimensional thickness of the buccal plate measurements indicates less bone loss and better healing.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.3||0.022|ONE_SIDED|95.0|||||t-test, 1 sided|The hypotheses will be tested using a one-sided t-test with a 5% significance level.||All secondary effectiveness endpoints were planned to be summarized descriptively, and no hypothesis tests was planned.||||0.022
73910099|NCT02612129|147350039|SUPERIORITY||Least Square (LS) Mean Difference|-1.4||||0.0456|TWO_SIDED|95.0|-2.76|-0.03|||GLMM for Repeated Measures|||A general linear mixed model (GLMM) for repeated measurements was used for the analysis of NPC disease severity assessed based on the 5-domain NPCCSS scores at Month 12. The general linear mixed model analysis for repeated measures was fitted with treatment, miglustat level and visit as fixed effects including treatment-by-visit interaction and baseline score as a covariate.||-0.03|-2.76|0.0456
73910100|NCT02612129|147350040|SUPERIORITY|||||||1|||||||Chi-squared Test|||||||1.0000
73910101|NCT02612129|147350041|SUPERIORITY|||||||0.5456|||||||Chi-squared Test|||||||0.5456
73910102|NCT02612129|147350042|SUPERIORITY|||||||0.8021|||||||Log-Rank Test|||Log-rank test had been stratified by miglustat use.||||0.8021
73910103|NCT02612129|147350043|SUPERIORITY|||||||0.3662|||||||Fisher's Exact Test|||Percentage of participants worsening at Month 6||||0.3662
73910104|NCT02612129|147350043|SUPERIORITY|||||||1|||||||Fisher's Exact Test|||Percentage of participants worsening at Month 12||||1.0000
73910105|NCT02612129|147350044|SUPERIORITY||LS Mean Difference|-1.69||||0.1546|TWO_SIDED|95.0|-4.04|0.66|||ANCOVA|||Change From Baseline in 17-Domain NPCCSS Apart from Hearing Domains (i.e. Hearing and Auditory Brainstem Response) at Month 6 was analyzed using the Analysis of covariance (ANCOVA) model. ANCOVA model was fitted with treatment, baseline full-scale NPCCSS apart from hearing domains score, and use of miglustat as covariates.||0.66|-4.04|0.1546
73910106|NCT02612129|147350044|SUPERIORITY||LS Mean Difference|-1.61||||0.2199|TWO_SIDED|95.0|-4.24|1.01|||ANCOVA|||Change From Baseline in 17-Domain NPCCSS Apart from Hearing Domains (i.e. Hearing and Auditory Brainstem Response) at Month 12 was analyzed using the ANCOVA model. ANCOVA model is fitted with treatment, baseline full-scale NPCCSS apart from hearing domains score, and use of miglustat as covariates.||1.01|-4.24|0.2199
73964852|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline at Day 15||||<0.001
73910107|NCT02612129|147350045|SUPERIORITY||Least Square (LS) Mean Difference|-1.11||||0.0188|TWO_SIDED|95.0|-2.03|-0.19|||ANCOVA|||An ANCOVA model was fitted with treatment, baseline 5-domain NPCCSS score, and use of miglustat as covariates.||-0.19|-2.03|0.0188
73910108|NCT02612129|147350047|SUPERIORITY||LS Mean Difference|-5.09||||0.0536|TWO_SIDED|95.0|-10.26|0.08|||ANCOVA|||"Change from baseline in the NPC-CDB score (modified Stampfer Score) at Month 6 was analyzed using the ANCOVA model. ANCOVA model was fitted with treatment, baseline NPC-CDB total score and use of miglustat as covariates."||0.08|-10.26|0.0536
73964853|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||<0.001
73910109|NCT02612129|147350047|SUPERIORITY||LS Mean Difference|-3.03||||0.3785|TWO_SIDED|95.0|-9.9|3.85|||ANCOVA|||"Change from baseline in the NPC-CDB score (modified Stampfer Score) at Month 12 was analyzed using the ANCOVA model. ANCOVA model was fitted with treatment, baseline NPC-CDB total score and use of miglustat as covariates."||3.85|-9.90|0.3785
73910110|NCT02612129|147350048|SUPERIORITY|||||||0.6951|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 6 in Quality of Life (EQ-5D-Y) being 'Better'||||0.6951
73910111|NCT02612129|147350048|SUPERIORITY|||||||0.7542|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 6 in Quality of Life (EQ-5D-Y) being 'Worse'||||0.7542
73910112|NCT02612129|147350048|SUPERIORITY|||||||0.488|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 12 in Quality of Life (EQ-5D-Y) being 'Better'||||0.4880
73910113|NCT02612129|147350048|SUPERIORITY|||||||0.1804|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 12 in Quality of Life (EQ-5D-Y) being 'Worse'||||0.1804
73910114|NCT02612129|147350049|SUPERIORITY||LS Mean Difference|0.74||||0.371|TWO_SIDED|95.0|-0.92|2.4|||ANCOVA|||Change from baseline in the SARA score at Month 6 was measured using an ANCOVA model. ANCOVA model was fitted with treatment, baseline SARA score, and use of miglustat as covariates.||2.40|-0.92|0.3710
73910115|NCT02612129|147350049|SUPERIORITY||LS Mean Difference|0.28||||0.7899|TWO_SIDED|95.0|-1.82|2.37|||ANCOVA|||Change from baseline in the SARA score at Month 12 was measured using an ANCOVA model. ANCOVA model was fitted with treatment, baseline SARA score and use of miglustat as covariates.||2.37|-1.82|0.7899
73964854|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||<0.001
73910116|NCT02612129|147350050|SUPERIORITY||LS Mean Difference|-10.34||||0.6195|TWO_SIDED|95.0|-53.01|32.33|||ANCOVA|||Dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 6 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||32.33|-53.01|0.6195
73910117|NCT02612129|147350050|SUPERIORITY||LS Mean Difference|-15.87||||0.4693|TWO_SIDED|95.0|-60.73|29.0|||ANCOVA|||Non-dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 6 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||29.00|-60.73|0.4693
74088522|NCT01746264|147730429|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.32
73910118|NCT02612129|147350050|SUPERIORITY||LS Mean Difference|3.2||||0.7283|TWO_SIDED|95.0|-15.71|22.12|||ANCOVA|||Dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 12 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||22.12|-15.71|0.7283
73910119|NCT02612129|147350050|SUPERIORITY||LS Mean Difference|-5.91||||0.7708|TWO_SIDED|95.0|-47.54|35.72|||ANCOVA|||Non-dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 12 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||35.72|-47.54|0.7708
73910120|NCT00717093|147350084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001|TWO_SIDED|95.0|1.59|3.58||p-values obtained from logistic regression model including main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values imputed as negative|Odds ratio obtained from logistic regression model including main effects of treatment and center|||3.58|1.59|<0.0001
73910121|NCT00717093|147350085|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.0118|TWO_SIDED|95.0|1.12|2.58||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values were imputed as negative|Odds Ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26||2.58|1.12|0.0118
73910122|NCT00717093|147350086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0063|TWO_SIDED|95.0|1.17|2.67|||Regression, Logistic|Missing salivary cotinine values were imputed as negative.||||2.67|1.17|0.0063
73910123|NCT00717093|147350087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.52|3.41||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 12||3.41|1.52|<0.0001
73910124|NCT00717093|147350087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.0919|TWO_SIDED|95.0|0.94|2.13||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26||2.13|0.94|0.0919
73910125|NCT00531934|147350088|SUPERIORITY_OR_OTHER|||||||0.175|||||||Chi-squared|||||||0.175
73910126|NCT00531934|147350091|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3 intensity skin rash (folliculitis)||||<0.001
74088523|NCT01746264|147730430|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.47
73910127|NCT00531934|147350097|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.763||||0.143|TWO_SIDED|95.0|0.525|1.109|||Log Rank|||||1.109|0.525|0.143
73910128|NCT00531934|147350100|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.769||||0.153|TWO_SIDED|95.0|0.529|1.116|||Log Rank|||||1.116|0.529|0.153
73910129|NCT00531934|147350106|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3||||0.003
73910130|NCT02975336|147350239|SUPERIORITY||Odds Ratio (OR)|1.55||||0.5462|TWO_SIDED|95.0|0.91|2.64|||Regression, Logistic|||||2.64|0.91|0.5462
73910131|NCT02975336|147350239|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5462|TWO_SIDED|95.0|0.76|2.18|||Regression, Logistic|||||2.18|0.76|0.5462
73910132|NCT02975336|147350239|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5462|TWO_SIDED|95.0|0.67|1.93|||Regression, Logistic|||||1.93|0.67|0.5462
73910133|NCT02975336|147350240|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5462|TWO_SIDED|95.0|0.69|3.24|||Regression, Logistic|||||3.24|0.69|0.5462
73910134|NCT02975336|147350240|SUPERIORITY||Odds Ratio (OR)|1.42||||0.5462|TWO_SIDED|95.0|0.68|2.97|||Regression, Logistic|||||2.97|0.68|0.5462
73910135|NCT02975336|147350240|SUPERIORITY||Odds Ratio (OR)|1.27||||0.5462|TWO_SIDED|95.0|0.59|2.75|||Regression, Logistic|||||2.75|0.59|0.5462
73910136|NCT02975336|147350268|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.7034|TWO_SIDED|95.0|0.57|2.4|||Cox proportional hazards model|||||2.40|0.57|0.7034
73910137|NCT02975336|147350268|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.5462|TWO_SIDED|95.0|0.31|1.52|||Cox proportional hazards model|||||1.52|0.31|0.5462
73910138|NCT02975336|147350268|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5462|TWO_SIDED|95.0|0.42|1.97|||Cox proportional hazards model|||||1.97|0.42|0.5462
73910139|NCT02975336|147350269|SUPERIORITY||Odds Ratio (OR)|1.52||||0.5462|TWO_SIDED|95.0|0.74|3.15|||Regression, Logistic|||||3.15|0.74|0.5462
73910140|NCT02975336|147350269|SUPERIORITY||Odds Ratio (OR)|1.03||||0.5462|TWO_SIDED|95.0|0.49|2.13|||Regression, Logistic|||||2.13|0.49|0.5462
73910141|NCT02975336|147350269|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5462|TWO_SIDED|95.0|0.65|2.81|||Regression, Logistic|||||2.81|0.65|0.5462
73910142|NCT02975336|147350270|SUPERIORITY||Odds Ratio (OR)|1.6||||0.2434|TWO_SIDED|95.0|0.73|3.54|||Regression, Logistic|||||3.54|0.73|0.2434
73910143|NCT02975336|147350270|SUPERIORITY||Odds Ratio (OR)|1.62||||0.2389|TWO_SIDED|95.0|0.73|3.63|||Regression, Logistic|||||3.63|0.73|0.2389
73910144|NCT02975336|147350270|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1952|TWO_SIDED|95.0|0.76|3.85|||Regression, Logistic|||||3.85|0.76|0.1952
73910145|NCT02975336|147350271|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.0987|TWO_SIDED|95.0|0.87|2.89|||Cox proportional hazards model|||||2.89|0.87|0.0987
73910146|NCT02975336|147350271|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9201|TWO_SIDED|95.0|0.51|1.85|||Cox proportional hazards model|||||1.85|0.51|0.9201
73910147|NCT02975336|147350271|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.5645|TWO_SIDED|95.0|0.6|2.2|||Cox proportional hazards model|||||2.20|0.60|0.5645
73910148|NCT02975336|147350272|SUPERIORITY||Odds Ratio (OR)|0.77||||0.3743|TWO_SIDED|95.0|0.44|1.37|||Regression, Logistic|||||1.37|0.44|0.3743
73910149|NCT02975336|147350272|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6445|TWO_SIDED|95.0|0.5|1.54|||Regression, Logistic|||||1.54|0.50|0.6445
73910150|NCT02975336|147350272|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2634|TWO_SIDED|95.0|0.41|1.28|||Regression, Logistic|||||1.28|0.41|0.2634
73964855|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||<0.001
73964856|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||<0.001
73964857|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||<0.001
73964858|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||<0.001
73964859|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 71||||<0.001
73964860|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 71||||<0.001
74026546|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||||TWO_SIDED|80.0|0.54|7.62||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||7.62|0.54|
74026547|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|80.0|-3.66|2.27||||||Compared with Baseline (Pre-dinner)||2.27|-3.66|
73910151|NCT02975336|147350273|SUPERIORITY||Rate Ratio|1.59||||0.2989|TWO_SIDED|95.0|0.66|3.81||Nominal p-value|Negative binomial regression|||||3.81|0.66|0.2989
73910152|NCT02975336|147350273|SUPERIORITY||Rate Ratio|0.85||||0.7325|TWO_SIDED|95.0|0.33|2.19||Nominal p-value|Negative binomial regression|||||2.19|0.33|0.7325
73910153|NCT02975336|147350273|SUPERIORITY||Rate Ratio|1.29||||0.591|TWO_SIDED|95.0|0.51|3.22||Nominal p-value|Negative binomial regression|||||3.22|0.51|0.5910
73964861|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 85||||<0.001
73964862|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 85||||<0.001
73964863|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||<0.001
73964864|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||<0.001
73910154|NCT02975336|147350274|SUPERIORITY||Odds Ratio (OR)|1.33||||0.3635|TWO_SIDED|95.0|0.72|2.47|||Regression, Logistic|||||2.47|0.72|0.3635
73910155|NCT02975336|147350274|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0329|TWO_SIDED|95.0|1.06|3.56|||Regression, Logistic|||||3.56|1.06|0.0329
73910156|NCT02975336|147350274|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7619|TWO_SIDED|95.0|0.59|2.07|||Regression, Logistic|||||2.07|0.59|0.7619
73910157|NCT02975336|147350275|SUPERIORITY||Odds Ratio (OR)|1.36||||0.2642|TWO_SIDED|95.0|0.79|2.35|||Regression, Logistic|||||2.35|0.79|0.2642
74026548|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.06|||||TWO_SIDED|80.0|1.7|8.43||||||Compared with Baseline (Pre-dinner)||8.43|1.70|
74026549|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.42|||||TWO_SIDED|80.0|-0.1|6.94||||||Compared with Baseline (Pre-dinner)||6.94|-0.10|
74026550|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.12|||||TWO_SIDED|80.0|-8.42|0.18||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.18|-8.42|
73910158|NCT02975336|147350275|SUPERIORITY||Odds Ratio (OR)|1.49||||0.1489|TWO_SIDED|95.0|0.87|2.57|||Regression, Logistic|||||2.57|0.87|0.1489
73910159|NCT02975336|147350275|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9285|TWO_SIDED|95.0|0.56|1.7|||Regression, Logistic|||||1.70|0.56|0.9285
73910160|NCT02975336|147350278|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9061|TWO_SIDED|95.0|0.49|1.88|||Regression, Logistic|||||1.88|0.49|0.9061
73910161|NCT02975336|147350278|SUPERIORITY||Odds Ratio (OR)|1.19||||0.6053|TWO_SIDED|95.0|0.61|2.31|||Regression, Logistic|||||2.31|0.61|0.6053
73910162|NCT02975336|147350278|SUPERIORITY||Odds Ratio (OR)|0.8||||0.52|TWO_SIDED|95.0|0.4|1.59|||Regression, Logistic|||||1.59|0.40|0.5200
73910163|NCT02975336|147350287|SUPERIORITY||Rate difference|5.9|||||TWO_SIDED|95.0|-9.7|21.2||||||||21.2|-9.7|
73910164|NCT02975336|147350287|SUPERIORITY||Rate Difference|0.6|||||TWO_SIDED|95.0|-14.5|15.6||||||||15.6|-14.5|
73910165|NCT02975336|147350287|SUPERIORITY||Rate difference|1.6|||||TWO_SIDED|95.0|-13.5|16.6||||||||16.6|-13.5|
73910166|NCT02975336|147350291|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7728|TWO_SIDED|95.0|0.46|2.82|||Regression, Logistic|||||2.82|0.46|0.7728
73910167|NCT02975336|147350291|SUPERIORITY||Odds Ratio (OR)|0.66||||0.3314|TWO_SIDED|95.0|0.28|1.54|||Regression, Logistic|||||1.54|0.28|0.3314
73910168|NCT02975336|147350291|SUPERIORITY||Odds Ratio (OR)|0.85||||0.7205|TWO_SIDED|95.0|0.36|2.04|||Regression, Logistic|||||2.04|0.36|0.7205
73910169|NCT02975336|147350292|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8364|TWO_SIDED|95.0|0.35|3.71|||Regression, Logistic|||||3.71|0.35|0.8364
73910170|NCT02975336|147350292|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8287|TWO_SIDED|95.0|0.37|3.45|||Regression, Logistic|||||3.45|0.37|0.8287
73910171|NCT02975336|147350292|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7621|TWO_SIDED|95.0|0.35|4.16|||Regression, Logistic|||||4.16|0.35|0.7621
73910172|NCT02975336|147350293|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8464|TWO_SIDED|95.0|0.23|3.31|||Regression, Logistic|||||3.31|0.23|0.8464
73964865|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||<0.001
73910173|NCT02975336|147350293|SUPERIORITY||Odds Ratio (OR)|0.59||||0.417|TWO_SIDED|95.0|0.16|2.12|||Regression, Logistic|||||2.12|0.16|0.4170
73910174|NCT02975336|147350293|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9988|TWO_SIDED|95.0|0.27|3.74|||Regression, Logistic|||||3.74|0.27|0.9988
73910175|NCT02975336|147350294|SUPERIORITY||Odds Ratio (OR)|1.13||||0.697|TWO_SIDED|95.0|0.62|2.04|||Regression, Logistic|||||2.04|0.62|0.6970
73910176|NCT02975336|147350294|SUPERIORITY||Odds Ratio (OR)|1.34||||0.3234|TWO_SIDED|95.0|0.75|2.42|||Regression, Logistic|||||2.42|0.75|0.3234
73910177|NCT02975336|147350294|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9846|TWO_SIDED|95.0|0.54|1.82|||Regression, Logistic|||||1.82|0.54|0.9846
73910178|NCT03019575|147350299|OTHER|Linear Mixed Model|Geometric Mean Ratio|9.43|||||TWO_SIDED|95.0|7.44|11.97||||||||11.97|7.44|
73910179|NCT00533897|147350316|SUPERIORITY_OR_OTHER||estimate of difference|9.59||||0.119|TWO_SIDED|95.0|0.83|18.34||There was no adjustment made for multiple comparisons.|Chi-squared, Corrected|||A continuity corrected Chi-square test was used to compare percentage of positive antibody responses of SC placebo vs. SC abatacept (Period II treatment groups) on Day 169. P-value was evaluated at 0.05 significance level (2-sided). 95% confidence interval (CI) for difference (SC PLA - SC ABA) between ABA and PLA in the immunogenicity rates was also calculated. Point estimates of the immunogenicity rates within the two Period II treatment group and the corresponding 95% CIs were also provided.||18.34|0.83|0.119
73910180|NCT00533897|147350317|SUPERIORITY_OR_OTHER||Estimate of Difference|4.88|||||TWO_SIDED|95.0|-4.5|14.25||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.||14.25|-4.50|
73964866|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||<0.001
73964867|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 120||||<0.001
73910181|NCT00533897|147350321|SUPERIORITY_OR_OTHER||Estimate of Difference|0.11|||||TWO_SIDED|95.0|-8.21|8.43||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.||8.43|-8.21|
73910182|NCT03228433|147350400|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The least squares(LS) means and difference of least squares (LS) means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals (CIs).|Least Squares (LS) Mean Difference|0.951|||||TWO_SIDED|90.0|0.823|1.099||||||||1.099|0.823|
73910183|NCT03228433|147350400|EQUIVALENCE|A linear regression model (power model), log (ln) (parameter) equal to (=) intercept plus (+) slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln(0.8) per (/)l n(r) to 1 + ln(1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.14|||||TWO_SIDED|90.0|1.04|1.25||||||||1.25|1.04|
73910184|NCT03228433|147350401|EQUIVALENCE|Bioequivalence interval of 627.51 to 659.59|LS Mean Difference|0.951|||||TWO_SIDED|90.0|0.825|1.097||||||||1.097|0.825|
73910185|NCT03228433|147350401|EQUIVALENCE|A linear regression model (power model), ln (parameter) = intercept + slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.11|||||TWO_SIDED|90.0|1.0|1.22||||||||1.22|1.00|
73910186|NCT03228433|147350402|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The LS means and difference of LS means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals CIs.|LS Mean Difference|0.58|||||TWO_SIDED|90.0|0.431|0.781||||||||0.781|0.431|
73910187|NCT03228433|147350402|EQUIVALENCE|A linear regression model (power model), ln (parameter) = intercept + slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.06||||||90.0|0.96|1.17||||||||1.17|0.96|
73910188|NCT01419626|147350436|SUPERIORITY||Difference in LS mean|-0.461|||<|0.001|TWO_SIDED|95.0|-0.581|-0.341|||ANCOVA|||Statistical analysis at Week 4||-0.341|-0.581|<0.001
73910189|NCT01419626|147350436|SUPERIORITY||Difference in LS mean|-0.669|||<|0.001|TWO_SIDED|95.0|-0.789|-0.549|||ANCOVA|||Statistical analysis at Week 4||-0.549|-0.789|<0.001
73910190|NCT01419626|147350436|SUPERIORITY|Statistical analysis at Week 4|Difference in LS mean|-0.208|||<|0.001|TWO_SIDED|95.0|-0.326|-0.09|||ANCOVA|||||-0.090|-0.326|<0.001
73964868|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 120||||<0.001
73964869|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 148||||<0.001
73964870|NCT04714320|147465412|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 148||||=0.002
73964871|NCT04714320|147465412|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 169||||<0.001
73964872|NCT04714320|147465412|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 169||||=0.002
73910191|NCT01419626|147350437|SUPERIORITY||Difference in LS mean|-0.494|||<|0.001|TWO_SIDED|95.0|-0.625|-0.363|||ANCOVA|||Statistical analysis at Week 4||-0.363|-0.625|<0.001
73910192|NCT01419626|147350437|SUPERIORITY||Difference in LS mean|-0.697|||<|0.001|TWO_SIDED|95.0|-0.828|-0.567|||ANCOVA|||Statistical analysis at Week 4||-0.567|-0.828|<0.001
73910193|NCT01419626|147350437|SUPERIORITY||Difference in LS mean|-0.203||||0.002||95.0|-0.333|-0.074|||ANCOVA|||Statistical analysis at Week 4||-0.074|-0.333|0.002
73910194|NCT01419626|147350438|SUPERIORITY||Difference in LS mean|-0.04|||<|0.001|TWO_SIDED|95.0|-0.059|-0.021|||ANCOVA|||Statistical analysis at Week 2||-0.021|-0.059|<0.001
73964873|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 15||||<0.001
73964874|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 15||||<0.001
73964875|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day at 29||||<0.001
73910195|NCT01419626|147350438|SUPERIORITY||Difference in LS mean|-0.044|||<|0.001||95.0|-0.064|-0.025|||ANCOVA|||Statistical analysis at Week 2||-0.025|-0.064|<0.001
73910196|NCT01419626|147350438|SUPERIORITY||Difference in LS mean|-0.004||||0.671|TWO_SIDED|95.0|-0.023|0.015|||ANCOVA|||Statistical analysis at Week 2||0.015|-0.023|0.671
73910197|NCT01419626|147350438|SUPERIORITY||Difference in LS mean|-0.091|||<|0.001|TWO_SIDED|95.0|-0.121|-0.061|||ANCOVA|||Statistical analysis at Week 4||-0.061|-0.121|<0.001
73910198|NCT01419626|147350438|SUPERIORITY||Difference in LS mean|-0.144|||<|0.001|TWO_SIDED|95.0|-0.175|-0.114|||ANCOVA|||Statistical analysis at Week 4||-0.114|-0.175|<0.001
73910199|NCT01419626|147350438|SUPERIORITY||Difference in LS mean|-0.053|||<|0.001|TWO_SIDED|95.0|-0.083|-0.023|||ANCOVA|||Statistical analysis at Week 4||-0.023|-0.083|<0.001
73910200|NCT01419626|147350439|SUPERIORITY||Difference in LS mean|-0.09|||<|0.001|TWO_SIDED|95.0|-0.115|-0.065|||ANCOVA|||Statistical analysis at Week 2||-0.065|-0.115|<0.001
73910201|NCT01419626|147350439|SUPERIORITY||Difference in LS mean|-0.164|||<|0.001|TWO_SIDED|95.0|-0.189|-0.138|||ANCOVA|||Statistical analysis at Week 2||-0.138|-0.189|<0.001
73910202|NCT01419626|147350439|SUPERIORITY||Difference in LS mean|-0.073|||<|0.001|TWO_SIDED|95.0|-0.099|-0.048|||ANCOVA|||Statistical analysis at Week 2||-0.048|-0.099|<0.001
73910203|NCT01419626|147350439|SUPERIORITY||Difference in LS mean|-0.15|||<|0.001|TWO_SIDED|95.0|-0.18|-0.12|||ANCOVA|||Statistical analysis at Week 4||-0.120|-0.180|<0.001
73910204|NCT01419626|147350439|SUPERIORITY||Difference in LS mean|-0.257|||<|0.001|TWO_SIDED|95.0|-0.287|-0.226|||ANCOVA|||Statistical analysis at Week 4||-0.226|-0.287|<0.001
73964876|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day at 29||||<0.001
73964877|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 43||||<0.001
73964878|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 43||||<0.001
73964879|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 57||||<0.001
73910205|NCT01419626|147350439|SUPERIORITY||Difference in LS mean|-0.107|||<|0.001|TWO_SIDED|95.0|-0.137|-0.077|||ANCOVA|||Statistical analysis at Week 4||-0.077|-0.137|<0.001
73910206|NCT01419626|147350440|SUPERIORITY||Difference in LS mean|-0.362|||<|0.001|TWO_SIDED|95.0|-0.465|-0.259|||ANCOVA|||Statistical analysis at Week 2||-0.259|-0.465|<0.001
73910207|NCT01419626|147350440|SUPERIORITY||Difference in LS mean|-0.534|||<|0.001|TWO_SIDED|95.0|-0.637|-0.431|||ANCOVA|||Statistical analysis at Week 2||-0.431|-0.637|<0.001
73910208|NCT01419626|147350440|SUPERIORITY||Difference in LS mean|-0.171||||0.001|TWO_SIDED|95.0|-0.273|-0.069|||ANCOVA|||Statistical analysis at Week 2||-0.069|-0.273|0.001
73910209|NCT01419626|147350441|SUPERIORITY||Difference in LS mean|-0.401|||<|0.001|TWO_SIDED|95.0|-0.51|-0.292|||ANCOVA|||Statistical analysis at Week 2||-0.292|-0.510|<0.001
73910210|NCT01419626|147350441|SUPERIORITY||Difference in LS mean|-0.558|||<|0.001|TWO_SIDED|95.0|-0.667|-0.449|||ANCOVA|||Statistical analysis at Week 2||-0.449|-0.667|<0.001
73910211|NCT01419626|147350441|SUPERIORITY||Difference in LS mean|-0.157|||<|0.001|TWO_SIDED|95.0|-0.265|-0.049|||ANCOVA|||Statistical analysis at Week 2||-0.049|-0.265|<0.001
73910212|NCT01419626|147350442|SUPERIORITY||Difference in LS mean|-0.03|||<|0.001|TWO_SIDED|95.0|-0.046|-0.014|||ANCOVA|||Statistical analysis at Week 2||-0.014|-0.046|<0.001
73910213|NCT01419626|147350442|SUPERIORITY||Difference in LS mean|-0.039|||<|0.001|TWO_SIDED|95.0|-0.055|-0.023|||ANCOVA|||Statistical analysis at Week 2||-0.023|-0.055|<0.001
73910214|NCT01419626|147350442|SUPERIORITY||Difference in LS mean|-0.009||||0.294|TWO_SIDED|95.0|-0.025|0.007|||ANCOVA|||Statistical analysis at Week 2||0.007|-0.025|0.294
73910215|NCT01419626|147350442|SUPERIORITY||Difference in LS mean|-0.019||||0.02|TWO_SIDED|95.0|-0.035|-0.003|||ANCOVA|||Statistical analysis at Week 4||-0.003|-0.035|0.020
73964880|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 57||||<0.001
74085344|NCT03566238|147724396|SUPERIORITY|"ANCOVA model including treatment, baseline pruritus score at AM and PM, PFIC type, and age category was used for treatment comparisons. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."|LS mean difference|21.71|STANDARD_ERROR_OF_MEAN|9.892||0.0163|TWO_SIDED|95.0|1.87|41.54|||ANCOVA|||Analysis of the Proportion of Positive Pruritus Assessments at Participant Level over the 24-Week Treatment Period - Albireo ObsRO Instrument (AM and PM Scores)||41.54|1.87|0.0163
73910216|NCT01419626|147350442|SUPERIORITY||Difference in LS mean|-0.034|||<|0.001|TWO_SIDED|95.0|-0.05|-0.018|||ANCOVA|||Statistical analysis at Week 4||-0.018|-0.050|<0.001
73910217|NCT01419626|147350442|SUPERIORITY||Difference in LS mean|-0.015||||0.071|TWO_SIDED|95.0|-0.031|0.001|||ANCOVA|||Statistical analysis at Week 4||0.001|-0.031|0.071
73910218|NCT01419626|147350443|SUPERIORITY||Difference in LS mean|-0.067|||<|0.001||95.0|-0.083|-0.05|||ANCOVA|||Statistical analysis at Week 2||-0.050|-0.083|<0.001
73910219|NCT01419626|147350443|SUPERIORITY||Difference in LS mean|-0.083|||<|0.001|TWO_SIDED|95.0|-0.099|-0.066|||ANCOVA|||Statistical analysis at Week 2||-0.066|-0.099|<0.001
73910220|NCT01419626|147350443|SUPERIORITY||Difference in LS mean|-0.016||||0.057|TWO_SIDED|95.0|-0.032|0.0|||ANCOVA|||Statistical analysis at Week 2||0.000|-0.032|0.057
73910221|NCT01419626|147350443|SUPERIORITY||Difference in LS mean|-0.077|||<|0.001|TWO_SIDED|95.0|-0.095|-0.059|||ANCOVA|||Statistical analysis at Week 4||-0.059|-0.095|<0.001
73910222|NCT01419626|147350443|SUPERIORITY||Difference in LS mean|-0.101|||<|0.001|TWO_SIDED|95.0|-0.12|-0.083|||ANCOVA|||Statistical analysis at Week 4||-0.083|-0.120|<0.001
73910223|NCT01419626|147350443|SUPERIORITY||Difference in LS mean|-0.024||||0.009|TWO_SIDED|95.0|-0.042|-0.006|||ANCOVA|||Statistical analysis at Week 4||-0.006|-0.042|0.009
73910224|NCT01145625|147350459|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was claimed if the lower limit of the 95% Confidence Interval (CI) was greater than -6.565.|Mean Difference (Final Values)|-0.3||||0.917|TWO_SIDED|95.0|-6.0|5.4|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 24 data.||5.4|-6.0|0.9170
73910225|NCT01145625|147350460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||<|0.4158|TWO_SIDED|95.0|-3.4|8.2|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 12 data.||8.2|-3.4|<0.4158
73910226|NCT01145625|147350461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.598|TWO_SIDED|95.0|-7.1|4.1|||ANCOVA|P-value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 52 data.||4.1|-7.1|0.5980
73910227|NCT02130570|147350487|SUPERIORITY||Incidence rate ratio|0.52||||0.02|TWO_SIDED|95.0|0.3|0.91||This is the P-value for the adjusted IRR.|Regression poissant|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio|0.91|0.30|0.02
73910228|NCT02130570|147350488|SUPERIORITY||Incidence rate ratio|0.78||||0.01|TWO_SIDED|95.0|0.64|0.95||This is the p-value for the adjusted rate|Regression poissant|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio|0.95|0.64|0.01
73964881|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 71||||<0.001
73964882|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 71||||<0.001
73910229|NCT02130570|147350489|SUPERIORITY||Odds Ratio (OR)|1.08||||0.77|TWO_SIDED|95.0|0.64|1.85||This is the P-value for the adjusted Odds Ratio|Regression, Logistic|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect . OR: odds ratio|1.85|0.64|0.77
73910230|NCT02130570|147350490|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.91|TWO_SIDED|||||This is the P-value for the adjusted difference.|Regression, Linear|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect.|||0.91
73910231|NCT02130570|147350491|SUPERIORITY||Odds Ratio, log|0.85||||0.57|TWO_SIDED|95.0|0.47|1.51||"Please see the Other Statistical Analysis field for adjustments and the P-value computed for each survey question."|Regression, Logistic||"Please see the Other Statistical Analysis field for a list of the estimated value and 95% CI for each survey question."||"Please see the Other Statistical Analysis field for adjustments."|1.51|0.47|0.57
73910232|NCT04424888|147350494|SUPERIORITY|||||||0.21875|||||||Wilcoxon (Mann-Whitney)|||||||0.21875
73910233|NCT04424888|147350495|SUPERIORITY|||||||0.90625|||||||Wilcoxon (Mann-Whitney)|||||||0.90625
73910234|NCT04424888|147350496|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||Paired t-test for the species Akkermansia Munciphilae.||||0.020
73910235|NCT04424888|147350496|SUPERIORITY|||||||0.078|||||||t-test, 1 sided|||Paired t-test for the species Bifidobacterium infantis.||||0.078
73910236|NCT04424888|147350496|SUPERIORITY|||||||||||||||||Paired t-test for the species Clostridium beijerinckii.|No statistical test was conducted since Clostridium beijerinckii was not detected in any sample.|||
73910237|NCT04424888|147350496|SUPERIORITY|||||||0.2|||||||t-test, 1 sided|||Paired t-test for the species Clostridium butyricum.||||0.20
73910238|NCT04424888|147350496|SUPERIORITY|||||||0.12|||||||t-test, 1 sided|||Paired t-test for the species Anaerobutyricum hallii.||||0.12
73910239|NCT04424888|147350497|OTHER||||||||||||||||||All participants had the same number of sensors (3) throughout the study, so no statistical analysis is conducted.|||
73910240|NCT04424888|147350498|SUPERIORITY|||||||0.41|||||||t-test, 1 sided|||We test whether the average number of daily photos is greater in period 1 than in period 2.||||0.41
73910241|NCT04424888|147350499|SUPERIORITY|||||||0.13|||||||t-test, 1 sided|||We test whether the average time between consecutive scans is smaller in period 1 than in period 2.||||0.13
73910242|NCT03881670|147350509|OTHER|Friedman test||||||0.0023|||||||Friedman Test|||Change in ratings over time||||0.0023
73910243|NCT03881670|147350509|OTHER|Friedman test||||||0.4679|||||||Friedman Test|||change in ratings over time||||0.4679
73964883|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 85||||<0.001
73964884|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 85||||<0.001
73910244|NCT00467857|147350529|SUPERIORITY_OR_OTHER|||||||0.655||95.0|||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.||||0.655
73910245|NCT00467857|147350530|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||Wilcoxon-Rank Sum Test|||||||0.276
73910246|NCT00467857|147350531|SUPERIORITY_OR_OTHER|||||||0.375||95.0|||||Wilcoxon-Rank Sum Test|||||||0.375
73910247|NCT00467857|147350532|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Wilcoxon-Rank Sum Test|||||||0.039
73910248|NCT00467857|147350533|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||Wilcoxon-Rank Sum Test|||||||0.057
73910249|NCT00467857|147350534|SUPERIORITY_OR_OTHER|||||||0.646||95.0|||||Wilcoxon-Rank Sum Test|||||||0.646
73910250|NCT00467857|147350535|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Wilcoxon-Rank Sum Test|||||||0.788
73910251|NCT00467857|147350536|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Wilcoxon-Rank Sum Test|||||||0.960
73910252|NCT00467857|147350537|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.||||0.359
73910253|NCT00467857|147350538|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon-Rank Sum Test|||||||0.730
73910254|NCT00467857|147350539|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||Wilcoxon-Rank Sum Test|||||||0.348
73910255|NCT00467857|147350540|SUPERIORITY_OR_OTHER|||||||0.512||95.0|||||Wilcoxon-Rank Sum Test|||||||0.512
73910256|NCT00467857|147350541|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Chi-squared|||||||0.285
73910257|NCT00467857|147350542|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Fisher Exact|||||||0.024
73910258|NCT00579098|147350554|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||A p-value of \< 0.05 was considered statistically significant.|Log Rank|||||||0.75
73910259|NCT00579098|147350555|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||A p-value of \< 0.05 was considered statistically significant.|Log Rank|||||||0.37
73910260|NCT00579098|147350556|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.11
73964885|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 92||||<0.001
73964886|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables|Van Elteren|||Percent Change from Baseline at Day 92||||<0.001
73910261|NCT00579098|147350557|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||Comparison between treatment groups. A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.53
73910262|NCT00579098|147350558|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in total cholesterol was compared between treatment groups.||||<0.001
73910263|NCT00579098|147350558|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in LDL cholesterol was compared between treatment groups.||||<0.001
73910264|NCT00579098|147350558|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in HDL cholesterol was compared between treatment groups.||||0.92
73910265|NCT02002832|147350607|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|LS mean for the treatment difference(lurasidone-risperidone) at week 6 and its 95% confidence interval was presented based on the MMRM. Non-inferiority for lurasidone relative to risperidone was evaluated by comparing the upper bound of the 95% confidence interval to the non-inferiority margin of 7.0. Plots of estimates for change from baseline in PANSS total score based on MMRM over time (Week 1 to Week 6) with 95% confidence intervals was provided for each treatment group.|Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|1.0|6.3|||Mixed Models Analysis|||||6.3|1.0|
73910266|NCT03329508|147350612|SUPERIORITY||Differences of Least Square Means|-2.66|STANDARD_ERROR_OF_MEAN|0.85||0.0018|TWO_SIDED|95.0|-4.33|-1.0|||MMRM|||||-1.0|-4.33|0.0018
73910267|NCT03329508|147350612|SUPERIORITY||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|0.85||0.0001|TWO_SIDED|95.0|-4.96|-1.63|||MMRM|||||-1.63|-4.96|0.0001
73910268|NCT03329508|147350613|SUPERIORITY||Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.5|-1.81|||MMRM|||||-1.81|-3.50|<0.0001
73910269|NCT03329508|147350613|SUPERIORITY||Mean Difference (Final Values)|-2.66|STANDARD_ERROR_OF_MEAN|0.43|<|0.05|TWO_SIDED|95.0|-3.5|-1.81|||MMRM|||||-1.81|-3.50|<0.05
73910270|NCT03329508|147350614|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.67||0.0231|TWO_SIDED|95.0|-2.84|-0.21|||MMRM|||||-0.21|-2.84|0.0231
73910271|NCT03329508|147350614|SUPERIORITY||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|0.67||0.0092|TWO_SIDED|95.0|-3.06|-0.43|||MMRM|||||-0.43|-3.06|0.0092
73910272|NCT03329508|147350615|SUPERIORITY||Mean Difference (Net)|-1.17|STANDARD_ERROR_OF_MEAN|0.31||0.0001|TWO_SIDED|95.0|-1.77|-0.57|||MMRM|||||-0.57|-1.77|0.0001
73910273|NCT03329508|147350615|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.13|-0.92|||MMRM|||||-0.92|-2.13|<0.0001
73910274|NCT03329508|147350616|SUPERIORITY||Mean Difference (Net)|-2.18|STANDARD_ERROR_OF_MEAN|1.54||0.1589|TWO_SIDED|95.0|-5.21|0.85|||MMRM|||||0.85|-5.21|0.1589
73910275|NCT00569270|147350619|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||a priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak FEV1 of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.027
73910276|NCT00569270|147350620|SUPERIORITY_OR_OTHER||Spearman rho|0.19||||0.96||95.0||||A priori threshold for statistical significance: p=0.05|Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measure includes change in FEV1 post tiotropium||||0.96
73910277|NCT00569270|147350621|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak FRC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.318
73910278|NCT00569270|147350622|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||Statistical significance was p \< 0.05|Mixed Models Analysis|||Mean difference of Peak FVC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.078
73910279|NCT00569270|147350623|SUPERIORITY_OR_OTHER||Spearman rho|-0.26||||0.4||95.0|||||Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema (19 patients); measures include change in IC at trough tiotropium.||||0.4
73910280|NCT00569270|147350624|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak IC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.067
73910281|NCT00569270|147350625|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||A priori threshold for statistical significance: p\<0.05|Regression, Logistic|||Mean difference of Peak FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.615
73910282|NCT00569270|147350626|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||Statistical significance was p\<0.05|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.325
73910283|NCT00569270|147350627|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.345
73910284|NCT00569270|147350628|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough FRC(L) in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.068
73964887|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 106||||<0.001
73910285|NCT00569270|147350629|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of trough FVC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.589
73910286|NCT00569270|147350630|SUPERIORITY_OR_OTHER|||||||0.922||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough IC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.922
73910287|NCT00569270|147350631|SUPERIORITY_OR_OTHER|||||||-0.02||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||-0.02
73910288|NCT00569270|147350632|SUPERIORITY_OR_OTHER|||||||-0.13||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough TLC (L) of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||-0.13
73910289|NCT00569270|147350633|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Change in IC before and after dynamic hyperinflation. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.0001
73910290|NCT00569270|147350634|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Total lung capacity was similar in all groups and was not significant|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||>0.05
73910291|NCT00569270|147350635|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||A priori threshold for statistical significance: p= 0.05|Spearman rho|Spearman rho = -0.26||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema||||0.36
73910292|NCT00492531|147350641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.7|TWO_SIDED|95.0|-56.0|38.0|||ANCOVA|6 minute walk was based on ANCOVA model with treatment as a fixed effect and 6 minute walk distance, TRV stratum and study site as covariate.||||38|-56|0.70
73910293|NCT00843856|147350666|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.7
73910294|NCT01893203|147350668|SUPERIORITY_OR_OTHER|||||||0.375|||||||McNemar|||||||0.375
73910295|NCT00621959|147350672|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.546||95.0|-0.59|0.31||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA including treatment and center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.31|-0.59|0.546
73910296|NCT00621959|147350673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08||||0.442||95.0|-0.27|0.12||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.12|-0.27|0.442
73964888|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 106||||<0.001
73910297|NCT01758523|147350674|OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
73910298|NCT01758523|147350675|OTHER|||||||0.028|||||||Mixed Models Analysis|||||||0.028
73910299|NCT01758523|147350676|OTHER||Odds Ratio (OR)|2.49||||0.057|TWO_SIDED|95.0|0.96|6.45|||Chi-squared|||||6.45|0.96|0.057
73910300|NCT01758523|147350677|OTHER||Odds Ratio (OR)|5.5||||0.007|TWO_SIDED|95.0|1.5|20.7|||Fisher Exact|||||20.7|1.5|0.007
73910301|NCT01758523|147350678|OTHER|||||||0.87||||||significance for drug x AKR1C3\*2 G-carrier genotype|Mixed Models Analysis|||||||0.87
73910302|NCT01758523|147350679|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.030
73964889|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 120||||<0.001
73964890|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 120||||<0.001
73964891|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 148||||<0.001
73964892|NCT04714320|147465413|SUPERIORITY||||||=|0.005||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 148||||=0.005
73910303|NCT04729621|147350685|EQUIVALENCE|Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-1.45, +1.45).|Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.73|1.15||||||LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 52 in LS-BMD as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline LS-BMD and baseline weight as covariates. Missing outcomes imputed using multiple imputation methods under the MAR assumption.||1.15|-0.73|
73910304|NCT04729621|147350686|EQUIVALENCE|Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-20, +20).|Mean Difference (Net)|9.07|||||TWO_SIDED|95.0|-0.14|18.29||||||LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 26 in sCTX-1 as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline sCTX-1 and baseline weight as covariates. Missing outcomes are not imputed. Results below the limit of quantification (BLQ) are imputed as the low limit of quantification (LLOQ = 0.033 ng/mL).||18.29|-0.14|
73910305|NCT03439657|147350711|NON_INFERIORITY|Upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies Geometric Mean Concentration (GMC) ratio between the Control group and the Co-Ad group should be \<1.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.99|1.16|||ANCOVA|The 95% CI of the group GMCs ratio was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-gE GMCs (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean concentrations (GMCs) for anti-gE antibodies, one month after the administration of last vaccine dose.||1.16|0.99|
73910306|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.04|||||TWO_SIDED|95.0|0.82|1.33|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-1), one month after the administration of Prevnar 13 vaccine dose.||1.33|0.82|
73910307|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.02|||||TWO_SIDED|95.0|0.86|1.22|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-3), one month after the administration of Prevnar 13 vaccine dose.||1.22|0.86|
73910308|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.25|||||TWO_SIDED|95.0|1.02|1.52|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-4), one month after the administration of Prevnar 13 vaccine dose.||1.52|1.02|
73964893|NCT04714320|147465413|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 169||||<0.001
73964894|NCT04714320|147465413|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 169||||=0.002
73964895|NCT04714320|147465414|SUPERIORITY||||||=|0.094||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline in 24-hour Mean SBP at Day 85||||=0.094
73964896|NCT04714320|147465414|SUPERIORITY||||||=|0.842||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline in 24-hour Mean SBP at Day 85||||=0.842
73964897|NCT04714320|147465414|SUPERIORITY||||||=|0.066||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in 24-hour Mean DBP at Day 85||||=0.066
73964898|NCT04714320|147465414|SUPERIORITY||||||=|0.442||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in 24-hour Mean DBP at Day 85||||=0.442
73964899|NCT04714320|147465415|SUPERIORITY||||||=|0.834||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 8||||=0.834
73910309|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.04|||||TWO_SIDED|95.0|0.81|1.32|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-5), one month after the administration of Prevnar 13 vaccine dose.||1.32|0.81|
73910310|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.26|||||TWO_SIDED|95.0|1.02|1.56|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6A), one month after the administration of Prevnar 13 vaccine dose.||1.56|1.02|
73910311|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.07|1.73|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6B), one month after the administration of Prevnar 13 vaccine dose.||1.73|1.07|
73910312|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.21|||||TWO_SIDED|95.0|1.01|1.44|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-7F), one month after the administration of Prevnar 13 vaccine dose.||1.44|1.01|
73910313|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.16|||||TWO_SIDED|95.0|0.97|1.39|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-9V), one month after the administration of Prevnar 13 vaccine dose.||1.39|0.97|
73910314|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.15|||||TWO_SIDED|95.0|0.94|1.42|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-14), one month after the administration of Prevnar 13 vaccine dose.||1.42|0.94|
73910315|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.92|1.34|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-18C), one month after the administration of Prevnar 13 vaccine dose.||1.34|0.92|
73910316|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.87|1.22|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19A), one month after the administration of Prevnar 13 vaccine dose.||1.22|0.87|
73964900|NCT04714320|147465415|SUPERIORITY||||||=|0.945||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 8||||=0.945
73964901|NCT04714320|147465415|SUPERIORITY||||||=|0.208||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 15||||=0.208
73964902|NCT04714320|147465415|SUPERIORITY||||||=|0.74||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 15||||=0.740
73964903|NCT04714320|147465415|SUPERIORITY||||||=|0.019||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 22||||=0.019
73964904|NCT04714320|147465415|SUPERIORITY||||||=|0.56||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 22||||=0.560
73910317|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.09|||||TWO_SIDED|95.0|0.9|1.32|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19F), one month after the administration of Prevnar 13 vaccine dose.||1.32|0.90|
73910318|NCT03439657|147350712|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.2|||||TWO_SIDED|95.0|0.96|1.5|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-23F), one month after the administration of Prevnar 13 vaccine dose.||1.50|0.96|
73910319|NCT00310401|147350728|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Paired T Test|||Paired T Test was used to compare the change in PaO2/FiO2 ratio from enrollment to procurement between albuterol and saline treated donors||||0.98
73910320|NCT00319501|147350733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.012|TWO_SIDED|95.0|0.34|0.88||p-value is adjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Cox Proportional Hazard||Age adjusted|Null hypothesis||0.88|0.34|0.012
73910321|NCT00319501|147350735|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED|||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact|||||||0.066
73910322|NCT00319501|147350736|SUPERIORITY_OR_OTHER|||||||0.443|||||||Fisher Exact|||||||0.443
73910323|NCT00319501|147350737|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact|||||||0.245
73910324|NCT00319501|147350738|SUPERIORITY_OR_OTHER||Difference in least square means|0.75||||0.086|TWO_SIDED|95.0|-0.11|1.61||p-Value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|ANOVA|ANOVA=analysis of variance.|Model included treatment and age category.|||1.61|-0.11|0.086
73910325|NCT00319501|147350739|SUPERIORITY_OR_OTHER||Difference in least square means|0.79||||0.045|TWO_SIDED|95.0|0.02|1.56||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|ANOVA||Model included treatment and age category.|||1.56|0.02|0.045
73910326|NCT01757535|147350762|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0009|TWO_SIDED|95.0|0.55|0.86||The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.|Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.||The confidence interval (CI) for the difference was derived using Kosorok's method.|0.86|0.55|0.0009
73910327|NCT01757535|147350763|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.52|0.8||The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.|Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.|||0.80|0.52|< 0.0001
73910328|NCT01757535|147350769|SUPERIORITY||Hazard Ratio (HR)|0.9345||||0.7522|TWO_SIDED|95.0|0.6136|1.4231||Stratification factors: • Age (at induction therapy): 55 to 64 years and ≥ 65 years • Prior history of MDS: yes/no • Cytogenetic risk (at induction therapy): intermediate-risk/poor-risk • Received consolidation therapy following induction: yes/no|Regression, Cox|||||1.4231|0.6136|0.7522
73964905|NCT04714320|147465415|SUPERIORITY||||||=|0.903||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure are included in Logistic Regression model, firth correction will be applied if quasi-complete separation of data points is detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 29||||=0.903
73964906|NCT04714320|147465415|SUPERIORITY||||||=|0.268||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure are included in Logistic Regression model, firth correction will be applied if quasi-complete separation of data points is detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 29||||=0.268
73910329|NCT00418015|147350775|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Log Rank|||Log rank test||||0.54
73910330|NCT00418015|147350776|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Log Rank|||||||0.15
73910331|NCT00418015|147350777|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared, Corrected|||||||0.06
73910332|NCT00418015|147350778|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared, Corrected|||||||0.02
73910333|NCT00418015|147350779|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.23
73910334|NCT00418015|147350779|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
73910335|NCT02903355|147350795|SUPERIORITY|||||||0.4385|||||||Fisher Exact|||||||.4385
73910336|NCT02903355|147350796|SUPERIORITY|||||||0.5562|||||||Fisher Exact|||||||.5562
73910337|NCT02903355|147350797|SUPERIORITY|||||||0.5441|||||||Fisher Exact|||||||.5441
73910338|NCT02903355|147350798|SUPERIORITY|||||||0.3666|||||||Fisher Exact|||||||.3666
73910339|NCT02903355|147350799|SUPERIORITY|||||||0.4446|||||||Fisher Exact|||||||.4446
73910340|NCT02903355|147350800|SUPERIORITY|||||||0.5431|||||||Fisher Exact|||||||.5431
73910341|NCT02903355|147350801|SUPERIORITY|||||||0.7409|||||||Fisher Exact|||||||.7409
73910342|NCT02903355|147350802|SUPERIORITY|||||||0.1597|||||||Fisher Exact|||||||.1597
73910343|NCT02903355|147350803|SUPERIORITY|||||||0.2784|||||||t-test, 1 sided|||||||.2784
73964907|NCT04714320|147465415|SUPERIORITY||||||=|0.702||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 36||||=0.702
74026551|NCT01933672|147606473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|||||TWO_SIDED|80.0|-2.6|5.89||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||5.89|-2.60|
74026552|NCT01933672|147606476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||||TWO_SIDED|80.0|0.21|1.39||||||Compared with baseline||1.39|0.21|
74026553|NCT01933672|147606476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|80.0|-0.43|0.93||||||Compared with baseline||0.93|-0.43|
74026554|NCT01933672|147606476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||||TWO_SIDED|80.0|-0.92|0.4||||||Compared with baseline||0.40|-0.92|
74026555|NCT01933672|147606476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|||||TWO_SIDED|80.0|0.17|1.95||||||||1.95|0.17|
74026556|NCT01933672|147606476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|||||TWO_SIDED|80.0|-0.45|1.47||||||||1.47|-0.45|
74026557|NCT00524303|147606515|SUPERIORITY_OR_OTHER||Percent difference|-9.0|||||TWO_SIDED|95.0|-38.1|17.9|||||Approximate 95% confidence interval for the difference in response rates between the trastuzumab arm and the lapatinib arm was calculated.|||17.9|-38.1|
73910344|NCT02903355|147350804|SUPERIORITY|||||||0.2303|||||||Fisher Exact|||||||.2303
73910345|NCT00094172|147350834|SUPERIORITY_OR_OTHER|||||||0.929|||||||Log Rank|||This is the primary analysis of the primary endpoint||||0.929
73910346|NCT00094172|147350834|SUPERIORITY_OR_OTHER|||||||0.823|||||||Fisher Exact|||This is the secondary analysis of the primary endpoint||||0.823
73910347|NCT00094172|147350835|SUPERIORITY_OR_OTHER|||||||0.208|||||||Log Rank|||||||.208
74026558|NCT00524303|147606515|SUPERIORITY_OR_OTHER||Percent difference|20.0|||||TWO_SIDED|95.0|-8.0|49.4|||||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.|||49.4|-8.0|
74026559|NCT00524303|147606516|SUPERIORITY_OR_OTHER||Percent Difference|7.0||||0.627|TWO_SIDED|95.0|-17.8|32.5|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the lapatinib arm was calculated.|||32.5|-17.8|0.627
74026560|NCT00524303|147606516|SUPERIORITY_OR_OTHER||Percent Difference|0.0||||1|TWO_SIDED|95.0|-25.1|25.1|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.|||25.1|-25.1|1.000
74026561|NCT00095121|147606550|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||End of double-blind treatment|Fisher Exact|||After unblinding the results, due to the small number of responders in the placebo group, it was determined that a statistical exact test would be more appropriate in the evaluation of treatment group differences than the originally planned 95% confidence intervals of the difference between the groups. Therefore, the results were analyzed by study visit, and a Fisher exact test was used to evaluate treatment differences between the adefovir dipivoxil and placebo groups.||||<0.001
73910348|NCT00094172|147350836|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||Log Rank|||||||0.526
73910349|NCT01392443|147350848|OTHER|||||||0.0007|||||||single-sample biniminal test|||||||0.0007
73910350|NCT01977794|147350853|SUPERIORITY_OR_OTHER||||||<|0.001||||||P value in both groups (Amlodipine failed and Bisoprolol failed) for comparison of SBP after 18 weeks versus baseline|Paired t test|||For each group (Amlodipine failed and Bisoprolol failed) SBP after 18 weeks compared to baseline (under monotherapy). Superiority was assessed between FDC and monotherapies.||||<0.001
73910351|NCT01895062|147350858|SUPERIORITY_OR_OTHER||||||<|0.022|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.022
73910352|NCT02478632|147350865|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.014|TWO_SIDED|95.0|0.27|2.31|||ANCOVA|||||2.31|0.27|0.014
73910353|NCT02478632|147350866|SUPERIORITY||Mean Difference (Final Values)|1.32||||0.039|TWO_SIDED|95.0|0.07|2.57|||ANCOVA|||||2.57|0.07|0.039
73910354|NCT02478632|147350869|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.016|TWO_SIDED|95.0|0.02|0.16||p value for the difference in adjusted change from Baseline at Week 48 in total hip T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated the difference between DTG+RPV and CAR in total hip T-scores|||0.16|0.02|0.016
73910355|NCT02478632|147350869|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.026|TWO_SIDED|95.0|0.01|0.15||p value for the difference in adjusted change from Baseline at Week 48 in total hip Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in total hip Z-score.|||0.15|0.01|0.026
74026562|NCT00095121|147606566|SUPERIORITY_OR_OTHER|||||||0.051||||||Comparison of HBeAg Loss|Fisher Exact|||||||0.051
74026563|NCT00095121|147606566|SUPERIORITY_OR_OTHER|||||||0.051||||||Comparison of HBeAg Seroconversion|Fisher Exact|||||||0.051
74026564|NCT00538642|147606578|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
74026565|NCT03167619|147606597|SUPERIORITY||MLE assuming exponential distribution|0.18||||0.0023|TWO_SIDED|95.0|0.11|0.27|||Chi-squared|Comparison to mean of historical control|Presence of patients with long PFS may have violated exponential assumption.|Assumed median PFS = 2.0 months as historical control, transformed to rate of 0.35/month||0.27|0.11|0.0023
74026566|NCT03167619|147606598|SUPERIORITY||MLE assuming exponential distribution|0.11|||<|0.0001|TWO_SIDED|95.0|0.07|0.19|||Chi-squared|Comparison to mean of historical control|Presence of patients with long PFS may have violated exponential assumption.|Assumed median PFS = 2.0 months as historical control, transformed to rate of 0.35/month||0.19|0.07|<0.0001
74026567|NCT02082184|147606605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.114||0.8222|TWO_SIDED||||||ANCOVA|||||||0.8222
74026568|NCT02082184|147606606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.58||0.7925|TWO_SIDED||||||ANCOVA|||||||0.7925
74026569|NCT02082184|147606607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.134|<|0.001|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \<70 mg/dL||||<0.001
74026570|NCT02082184|147606607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.068||0.0014|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \<55 mg/dL||||0.0014
74026571|NCT02082184|147606608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.065||0.0164|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<70 mg/dL||||0.0164
74026572|NCT02082184|147606608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.037||0.0017|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<55 mg/dL||||0.0017
73910356|NCT02478632|147350869|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.049|TWO_SIDED|95.0|0.0|0.23||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR for lumbar spine T-score.|||0.23|0.00|0.049
73910357|NCT02478632|147350869|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.013|TWO_SIDED|95.0|0.03|0.27||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in lumbar spine Z-score.|||0.27|0.03|0.013
73910358|NCT02478632|147350872|OTHER||Mean Difference (Final Values)|0.65|||||TWO_SIDED|95.0|-3.51|4.81|||||The analysis refers to INSTI and total hip.|||4.81|-3.51|
73910359|NCT02478632|147350872|OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|0.39|2.81|||||The analysis refers to NNRTI and total hip.|||2.81|0.39|
73910360|NCT02478632|147350872|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-1.39|3.38|||||this analysis refers to PI and total hip|||3.38|-1.39|
73910361|NCT02478632|147350872|OTHER||Mean Difference (Final Values)|3.85|||||TWO_SIDED|95.0|0.67|7.03|||||this analysis refers to INSTI and lumbar spine.|||7.03|0.67|
73910362|NCT02478632|147350872|OTHER||Mean Difference (Final Values)|1.25|||||TWO_SIDED|95.0|-0.26|2.76|||||this analysis refers to NNRTI and lumbar spine|||2.76|-0.26|
73910363|NCT02478632|147350872|OTHER||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-3.0|3.77|||||this analysis refers to PI and lumbar spine|||3.77|-3.00|
73910364|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.26|0.3|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent INSTI.|||0.30|-0.26|
73910365|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|0.03|0.19|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent NNRTI.|||0.19|0.03|
74026573|NCT02082184|147606609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.63||0.597|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>180 mg/dL||||0.5970
73910366|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.09|0.24|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent PI.|||0.24|-0.09|
73910367|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.25|0.37|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent INSTI.|||0.37|-0.25|
73910368|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|0.02|0.18|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent NNRTI.|||0.18|0.02|
73910369|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.14|0.21|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent PI.|||0.21|-0.14|
73910370|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|95.0|0.01|0.71|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent INSTI.|||0.71|0.01|
73910371|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.03|0.25|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent NNRTI.|||0.25|-0.03|
73910372|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.3|0.33|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent PI.|||0.33|-0.30|
73910373|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|0.03|0.74|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent INSTI.|||0.74|0.03|
73910374|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.02|0.26|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent NNRTI.|||0.26|-0.02|
73910375|NCT02478632|147350873|OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent PI.|||0.34|-0.26|
73910376|NCT03019185|147350878|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|13.37|STANDARD_ERROR_OF_MEAN|1.4111|<|0.0001|TWO_SIDED|95.0|10.48|16.27|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||16.27|10.48|<0.0001
73910377|NCT03019185|147350879|SUPERIORITY||LS Mean difference (Net)|9.49|STANDARD_ERROR_OF_MEAN|1.813|<|0.0001|TWO_SIDED|97.5|5.38|13.6|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 48 were included. Missing data were not imputed.|Difference is bardoxolone methyl - placebo|||13.60|5.38|<0.0001
73910378|NCT03019185|147350880|SUPERIORITY||LS Mean difference (Net)|7.65|STANDARD_ERROR_OF_MEAN|2.144||0.0005|TWO_SIDED|95.0|3.41|11.89|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 100 (excluding Week 52) were included. Missing data were not imputed.|Difference is bardoxolone methyl - placebo|||11.89|3.41|0.0005
73910379|NCT03019185|147350881|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 48.|LS Mean change from baseline|7.4|STANDARD_ERROR_OF_MEAN|1.9451||0.0008|TWO_SIDED|95.0|3.4|11.39|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 48 were included. Missing data were not imputed.||||11.39|3.40|0.0008
74026574|NCT02082184|147606609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8729|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>240 mg/dL||||0.8729
74026575|NCT02082184|147606612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.6075|TWO_SIDED||||||ANCOVA|||Perceived frequency of hyperglycaemia||||0.6075
73910380|NCT03019185|147350882|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 100.|LS Mean change from baseline|4.28|STANDARD_ERROR_OF_MEAN|1.7484||0.015|TWO_SIDED|95.0|0.84|7.72|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 100 (excluding Week 52) were included. Missing data were not imputed.||||7.72|0.84|0.0150
73910381|NCT03019185|147350883|SUPERIORITY||LS Mean difference (Net)|5.09|STANDARD_ERROR_OF_MEAN|1.656||0.0021|TWO_SIDED|97.5|1.37|8.8|||ANCOVA|Missing eGFR data were imputed using multiple imputation based on the treatment group to which the patient was assigned.|Difference is bardoxolone methyl - placebo|||8.80|1.37|0.0021
73910382|NCT03019185|147350884|SUPERIORITY||LS Mean difference (Net)|4.26|STANDARD_ERROR_OF_MEAN|1.876||0.0232|TWO_SIDED|95.0|0.58|7.94|||ANCOVA|Missing eGFR data were imputed using multiple imputation based on the treatment group to which the patient was assigned.|Difference is bardoxolone methyl - placebo|||7.94|0.58|0.0232
73910383|NCT03355365|147350885|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73910384|NCT03355365|147350886|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
73910385|NCT03355365|147350887|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
74026576|NCT02082184|147606612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2295|TWO_SIDED||||||ANCOVA|||Perceived frequency of hypoglycaemia||||0.2295
73910386|NCT03355365|147350888|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
73910387|NCT03355365|147350889|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||.43
73910388|NCT03355365|147350890|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
73910389|NCT03355365|147350891|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
73910390|NCT03355365|147350892|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||.71
73910391|NCT03355365|147350893|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
73910392|NCT02110238|147350894|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A VAS (0-100 mm) WOMAC Pain subscale score CFB; an equal n t-test for non-inferiority of means; a non-inferiority margin of -8 mm; change standard deviation of 26 mm; two-sided alpha=0.05; 80% power; an expected mean difference of 0, and a drop-out plus important deviation percentage of approximately 20% were used to establish study sample size.|Least square mean difference|-3.3|||||TWO_SIDED|95.0|-6.77|0.17|||||"A MERM regression model was fit to the change from baseline at weeks 3, 6, and 12. The over weeks 3, 6, and 12 single point estimate least square mean change was calculated for both arms, the difference and its 95% confidence interval calculated."|||0.17|-6.77|
73910393|NCT00142935|147350897|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||Outcome: engage in treatment post release, yes or no||||<0.001
73910394|NCT00142935|147350898|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared, Corrected|||||||.02
73910395|NCT00142935|147350899|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Chi-squared, Corrected|||||||.09
73910396|NCT00142935|147350900|SUPERIORITY_OR_OTHER|||||||0.09|||||||Chi-squared, Corrected|||||||.09
73910397|NCT00142935|147350902|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared, Corrected|||||||0.8
73910398|NCT03055156|147350924|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
73910399|NCT03055156|147350925|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
73910400|NCT03055156|147350926|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
73910401|NCT03055156|147350927|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
73910402|NCT03055156|147350928|OTHER|||||||0.02|||||||t-test, 2 sided|||Analysis of Wake values||||0.02
73910403|NCT03055156|147350928|OTHER|||||||0.06|||||||t-test, 2 sided|||Analysis of REM values||||0.06
73910404|NCT03055156|147350928|OTHER|||||||0.83|||||||t-test, 2 sided|||Analysis of Non REM stage 1 values||||0.83
73910405|NCT03055156|147350928|OTHER|||||||0.87|||||||t-test, 2 sided|||Analysis of Non REM stage 2 values||||0.87
73910406|NCT03055156|147350928|OTHER|||||||0.97|||||||t-test, 2 sided|||Analysis of Non REM stage 3 values||||0.97
73910407|NCT03055156|147350929|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
73910408|NCT03055156|147350930|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
73910409|NCT03055156|147350932|OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
73910410|NCT03055156|147350933|OTHER|||||||0.86|||||||t-test, 2 sided|||analysis of 0-90 minutes||||0.86
73910411|NCT03055156|147350933|OTHER|||||||0.29|||||||t-test, 2 sided|||analysis of 90-180 minutes||||0.29
73910412|NCT03055156|147350933|OTHER|||||||0.58|||||||t-test, 2 sided|||analysis of 180-270 minutes||||0.58
73910413|NCT03055156|147350933|OTHER|||||||0.62|||||||t-test, 2 sided|||analysis of 270-360 min||||0.62
73910414|NCT03055156|147350934|OTHER|||||||0.389|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to compare the difference in core body temperature trend over time between the two study arms. Interaction between time and topper type on CBT was calculated.||||0.389
73910415|NCT03055156|147350934|OTHER|||||||0.01|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect over time from both study arms on CBT. Main effect of time on CBT.||||0.01
73910416|NCT03055156|147350934|OTHER|||||||0.642|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect of the intervention on CBT including all time points. Main effect of topper type on CBT.||||0.642
73910417|NCT03055156|147350935|OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
73910418|NCT03055156|147350936|OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
73910419|NCT03055156|147350937|OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
73910420|NCT03779711|147350952|SUPERIORITY|||||||0.8095|||||||ANCOVA|adjusted for baseline FAC||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to 3-months post-surgery.||||0.8095
73910421|NCT03779711|147350953|SUPERIORITY|||||||0.3029|||||||ANCOVA|Adjusted for baseline circumferential strain||Analysis of covariance (ANCOVA), adjusted for baseline circumferential strain, is used to assess change in circumferential strain from baseline to 3-months post-surgery.||||0.3029
74026577|NCT02082184|147606612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED||||||ANCOVA|||Total treatment satisfaction score||||<0.001
73910422|NCT03779711|147350954|SUPERIORITY|||||||0.0323|||||||ANCOVA|Adjusted for baseline longitudinal strain||Analysis of covariance (ANCOVA), adjusted for baseline longitudinal strain, is used to assess change in longitudinal strain from baseline to 3-months post-surgery.||||0.0323
73910423|NCT03779711|147350955|SUPERIORITY|||||||0.6765|||||||ANCOVA|Adjusted for baseline FAC.||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to 12-months post-surgery.||||0.6765
73910424|NCT03779711|147350956|SUPERIORITY|||||||0.3456|||||||ANCOVA|Adjusted for baseline FAC||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to discharge.||||0.3456
73910425|NCT03779711|147350957|SUPERIORITY|||||||0.776|||||||Kruskal-Wallis|||Kruskal-Wallis test comparing number of days in hospital post stage-II surgery.||||0.7760
73910426|NCT03779711|147350958|SUPERIORITY|||||||0.9563|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in weight from baseline to 3-months post-surgery.||||0.9563
73910427|NCT03779711|147350959|SUPERIORITY|||||||0.9095|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in heart rate from baseline to 3-months post-surgery.||||0.9095
73910428|NCT03779711|147350960|SUPERIORITY|||||||0.6391|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in oxygen saturation from baseline to 3-months post-surgery.||||0.6391
73910429|NCT03779711|147350967|SUPERIORITY|||||||0.8782|||||||Kruskal-Wallis|||Kruskal-Wallis test comparing number of days in hospital post stage-II surgery||||0.8782
73910430|NCT05981391|147350968|SUPERIORITY|||||||0.01||||||Adjusted for multiple comparisons.|t-test, 2 sided|||||||0.01
73910431|NCT02390908|147350976|SUPERIORITY||Beta|0.22||||0.39|TWO_SIDED|95.0|-0.28|0.72||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.72|-0.28|0.39
73964908|NCT04714320|147465415|SUPERIORITY||||||=|0.885||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 36||||=0.885
73910432|NCT02390908|147350976|SUPERIORITY||Beta|-0.03||||0.94|TWO_SIDED|95.0|-0.84|0.79||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.79|-0.84|0.94
73910433|NCT02390908|147350976|SUPERIORITY||Beta|0.02||||0.95|TWO_SIDED|95.0|-0.69|0.74||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 3 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.74|-0.69|0.95
73910434|NCT02390908|147350976|SUPERIORITY||Beta|-0.32||||0.09|TWO_SIDED|95.0|-0.69|0.05||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3 (the Waitlist condition) and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of being in the Waitlist condition (i.e., not receiving the PLUS intervention at Site 3) on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.05|-0.69|0.09
73910435|NCT02390908|147350976|SUPERIORITY||Slope|-0.03||||0.79|TWO_SIDED|95.0|-0.24|0.18||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.18|-0.24|0.79
73910436|NCT02390908|147350976|SUPERIORITY||Slope|-0.12||||0.57|TWO_SIDED|95.0|-0.53|0.36||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.36|-0.53|0.57
73964909|NCT04714320|147465415|SUPERIORITY||||||=|0.066||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 43||||=0.066
73964910|NCT04714320|147465415|SUPERIORITY||||||=|0.783||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 43||||=0.783
73910437|NCT02390908|147350976|SUPERIORITY||Slope|0.01||||0.97|TWO_SIDED|95.0|-0.35|0.36||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 3 (Immediate) relative to the No-Treatment EMR Control.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.36|-0.35|0.97
73964911|NCT04714320|147465415|SUPERIORITY||||||=|0.456||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 50||||=0.456
73964912|NCT04714320|147465415|SUPERIORITY||||||=|0.102||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 50||||=0.102
73910438|NCT02390908|147350976|SUPERIORITY||Slope|0.07||||0.41|TWO_SIDED|95.0|-0.1|0.24||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.24|-0.10|0.41
73910439|NCT02390908|147350976|SUPERIORITY||Slope|0.06||||0.82|TWO_SIDED|95.0|-0.41|0.52||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.52|-0.41|0.82
73910440|NCT02390908|147350976|SUPERIORITY||Slope|0.14||||0.49|TWO_SIDED|95.0|-0.26|0.53||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.53|-0.26|0.49
73910441|NCT02390908|147350976|SUPERIORITY||Slope|-0.33||||0.18|TWO_SIDED|95.0|-0.8|0.15||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.15|-0.80|0.18
73910442|NCT02390908|147350976|SUPERIORITY||Slope|0.02||||0.89|TWO_SIDED|95.0|-0.28|0.32||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.32|-0.28|0.89
73910443|NCT02390908|147350977|SUPERIORITY||Beta|1.92||||0.95|TWO_SIDED|95.0|-54.68|58.53||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||58.53|-54.68|0.95
73910444|NCT02390908|147350977|SUPERIORITY||Beta|23.99||||0.61|TWO_SIDED|95.0|-67.54|115.51||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||115.51|-67.54|0.61
73910445|NCT02390908|147350977|SUPERIORITY||Beta|-23.71||||0.48|TWO_SIDED|95.0|-88.82|41.4||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 3 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||41.40|-88.82|0.48
73910446|NCT02390908|147350977|SUPERIORITY||Beta|4.19||||0.88|TWO_SIDED|95.0|-49.76|58.14||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3 (the Waitlist condition) and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of being in the Waitlist condition (i.e., not receiving the PLUS intervention at Site 3) on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||58.14|-49.76|0.88
73910447|NCT02390908|147350977|SUPERIORITY||Slope|7.67||||0.59|TWO_SIDED|95.0|-19.88|35.21||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||35.21|-19.88|0.59
73910448|NCT02390908|147350977|SUPERIORITY||Slope|-24.95||||0.24|TWO_SIDED|95.0|-66.78|16.88||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||16.88|-66.78|0.24
73910449|NCT02390908|147350977|SUPERIORITY||Slope|18.32||||0.15|TWO_SIDED|95.0|-6.63|43.27||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||43.27|-6.63|0.15
73910450|NCT02390908|147350977|SUPERIORITY||Slope|10.27||||0.33|TWO_SIDED|95.0|-10.2|30.74||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Waitlist relative to No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||30.74|-10.20|0.33
73910451|NCT02390908|147350977|SUPERIORITY||Slope|6.42||||0.8|TWO_SIDED|95.0|-44.24|57.09||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in CD4 count across the 12-,15-, and 18-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||57.09|-44.24|0.80
73910452|NCT02390908|147350977|SUPERIORITY||Slope|-5.43||||0.89|TWO_SIDED|95.0|-85.47|74.61||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in CD4 count across the 12-,15-, and 18-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||74.61|-85.47|0.89
73910453|NCT02390908|147350977|SUPERIORITY||Slope|1.16||||0.97|TWO_SIDED|95.0|-60.61|62.94||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||62.94|-60.61|0.97
73910454|NCT02390908|147350977|SUPERIORITY||Slope|-38.4||||0.07|TWO_SIDED|95.0|-79.51|2.72||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||2.72|-79.51|0.07
73910455|NCT02390908|147350978|SUPERIORITY||Beta|-7.87||||0.22|TWO_SIDED|95.0|-20.52|4.78||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||4.78|-20.52|0.22
73910456|NCT02390908|147350978|SUPERIORITY||Beta|10.29||||0.22|TWO_SIDED|95.0|-6.25|26.82||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||26.82|-6.25|0.22
73910457|NCT02390908|147350978|SUPERIORITY||Beta|-0.27||||0.96|TWO_SIDED|95.0|-11.63|11.08||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention immediately at Site 3 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||11.08|-11.63|0.96
73910458|NCT02390908|147350978|SUPERIORITY||Slope|6.34||||0.03|TWO_SIDED|95.0|0.72|11.97||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across the 3-, 6-, 9- and 12-month follow-ups for Site 1 relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||11.97|0.72|0.03
73910459|NCT02390908|147350978|SUPERIORITY||Slope|3.35||||0.42|TWO_SIDED|95.0|-4.78|11.47||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across the 3-, 6-, 9- and 12-month follow-ups for Site 2 relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||11.47|-4.78|0.42
73964913|NCT04714320|147465415|SUPERIORITY||||||=|0.668||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 57||||=0.668
73910460|NCT02390908|147350978|SUPERIORITY||Slope|0.34||||0.91|TWO_SIDED|95.0|-5.85|6.54||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across 3-,6-,9- and 12-month follow-ups for Site 3 (Immediate) relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||6.54|-5.85|0.91
73910461|NCT02390908|147350979|SUPERIORITY||Beta|3.19||||0.02|TWO_SIDED|95.0|0.61|5.78||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||5.78|0.61|0.02
73910462|NCT02390908|147350979|SUPERIORITY||Beta|-0.86||||0.63|TWO_SIDED|95.0|-4.33|2.61||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||2.61|-4.33|0.63
73910463|NCT02390908|147350979|SUPERIORITY||Beta|4.17||||0.02|TWO_SIDED|95.0|0.8|7.54||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention immediately at Site 3 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||7.54|0.80|0.02
73964914|NCT04714320|147465415|SUPERIORITY||||||=|0.454||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 57||||=0.454
74026578|NCT01062399|147606615|OTHER||||||||||||||||||A dose level for RAD001 will be considered acceptable if no patient of the first 3patients or no more than 2 patients of the first 6 patients experience a DLT. If the current level is considered acceptable, then dose escalation will occur and the protocol will be reopened. Otherwise, the preceding acceptable dose level will be declared the MTD.|||
74026579|NCT01062399|147606616|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.79|TWO_SIDED|95.0|0.82|1.6|||Log Rank||Reference arm = RT + TMZ|Assuming exponential distribution with median PFS (mPFS) time for control of 6.7 mos. for the control arm, tt was hypothesized that there would be a 43% improvement in mPFS time, corresponding to a mPFS time of 9.6. This is equivalent to a hazard ratio of 0.7 for the experimental arm vs. control arm. With a 1-sided significance level = 0.15 and 85% power, a total of 134 PFS events out of 180 eligible patients were required to detect the projected effect size.||1.60|0.82|0.79
74026580|NCT01062399|147606617|SUPERIORITY||Hazard Ratio (HR)|1.67||||0.008|TWO_SIDED|95.0|1.14|2.45|||Log Rank|2-sided significance level = 0.05|Reference level = RT + TMZ|||2.45|1.14|0.008
73910464|NCT02390908|147350979|SUPERIORITY||Slope|-0.4||||0.46|TWO_SIDED|95.0|-1.47|0.67||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 1 relative to that for the Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.67|-1.47|0.46
73910465|NCT02390908|147350979|SUPERIORITY||Slope|-0.29||||0.5|TWO_SIDED|95.0|-1.12|0.55||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 2 relative to that for the Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.55|-1.12|0.50
73910466|NCT02390908|147350979|SUPERIORITY||Slope|-0.35||||0.43|TWO_SIDED|95.0|-1.23|0.52||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 3 (Immediate) relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.52|-1.23|0.43
73910467|NCT01781975|147350980|SUPERIORITY||ANCOVA|0.0616|STANDARD_ERROR_OF_MEAN|0.0364||0.048|TWO_SIDED|90.0|0.00176|0.121|||ANCOVA|||||0.121|0.00176|0.048
73910468|NCT02905149|147351018|SUPERIORITY||Median Difference (Final Values)|9.0|||<|0.05|TWO_SIDED|95.0|4.0|14.5||Not adjusted for multiple comparison|Wilcoxon (Mann-Whitney)||Generalized Hodges-Lehmann median difference is used. These are robust to the possibility that the population distributions in the two groups are different in ways other than location. It may not represent the raw median difference.|||14.5|4|< 0.05
73910469|NCT00516074|147351070|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 25 subjects were intended to be randomized to both the exenatide and placebo arms. Assuming an approximate 24% dropout rate, 19 patients per treatment arm would complete the study. A sample of 19 patients per treatment group would provide 90% power to detect a 10 bpm difference between treatment groups in change in daily mean heart rate from baseline.||||||0.1585||95.0|||||ANCOVA|||||||0.1585
73964915|NCT04714320|147465415|SUPERIORITY||||||=|0.044||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 64||||=0.044
73964916|NCT04714320|147465415|SUPERIORITY||||||=|0.704||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 64||||=0.704
73910470|NCT00516074|147351071|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.1624||95.0|||||ANCOVA|||||||0.1624
73910471|NCT00516074|147351072|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.5077||95.0|||||ANCOVA|||||||0.5077
73910472|NCT00516074|147351073|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.9034||95.0|||||ANCOVA|||||||0.9034
73910473|NCT00516074|147351074|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.427||95.0|||||ANCOVA|||||||0.4270
73910474|NCT00516074|147351075|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.26||95.0|||||ANCOVA|||||||0.2600
73964917|NCT04714320|147465415|SUPERIORITY||||||=|0.878||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 71||||=0.878
73910475|NCT03540030|147351076|OTHER|||||||0.297|||||||Wilcoxon (Mann-Whitney)|||||||.297
73964918|NCT04714320|147465415|SUPERIORITY||||||=|0.681||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 71||||=0.681
73964919|NCT04714320|147465415|SUPERIORITY||||||=|0.199||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 78||||=0.199
73910476|NCT03540030|147351077|OTHER|||||||0.005||||||At the 6 hour time point|Wilcoxon (Mann-Whitney)|||||||0.005
73910477|NCT03540030|147351077|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||At the 12 hour time point||||0.005
73910478|NCT03540030|147351078|OTHER|||||||0.0801|||||||Fisher Exact|||||||0.0801
73910479|NCT03540030|147351079|OTHER|||||||0.0154|||||||Chi-squared|||||||0.0154
73910480|NCT03540030|147351080|OTHER|||||||0.2139|||||||Fisher Exact|||||||0.2139
73964920|NCT04714320|147465415|SUPERIORITY||||||=|0.602||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 78||||=0.602
73964921|NCT04714320|147465415|SUPERIORITY||||||=|0.135||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 85||||=0.135
73964922|NCT04714320|147465415|SUPERIORITY||||||=|0.407||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 85||||=0.407
73964923|NCT04714320|147465415|SUPERIORITY||||||=|0.795||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 92||||=0.795
73910481|NCT03540030|147351082|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
73910482|NCT03540030|147351083|OTHER|||||||0.9669|||||||Wilcoxon (Mann-Whitney)|||||||0.9669
73910483|NCT03540030|147351084|OTHER|||||||0.9208|||||||Wilcoxon (Mann-Whitney)|||||||.9208
73910484|NCT03540030|147351085|OTHER|||||||0.6481|||||||Wilcoxon (Mann-Whitney)|||For PCS only||||0.6481
73910485|NCT03540030|147351085|OTHER|||||||0.3911|||||||Wilcoxon (Mann-Whitney)|||For MCS only||||0.3911
73910486|NCT03540030|147351086|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
73964924|NCT04714320|147465415|SUPERIORITY||||||=|0.036||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 92||||=0.036
73910487|NCT03540030|147351087|OTHER|||||||0.3177|||||||Fisher Exact|||||||0.3177
73910488|NCT03540030|147351088|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
73910489|NCT03540030|147351089|OTHER|||||||0.2349|||||||Fisher Exact|||||||0.2349
73910490|NCT03540030|147351090|OTHER|||||||0.7892|||||||Wilcoxon (Mann-Whitney)|||||||0.7892
73964925|NCT04714320|147465415|SUPERIORITY||||||=|0.915||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 106||||=0.915
73964926|NCT04714320|147465415|SUPERIORITY||||||=|0.957||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 106||||=0.957
73964927|NCT04714320|147465415|SUPERIORITY||||||=|0.804||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 120||||=0.804
73910491|NCT03540030|147351091|OTHER|||||||0.2023|||||||Wilcoxon (Mann-Whitney)|||For PCS only||||0.2023
73910492|NCT03540030|147351091|OTHER|||||||0.2486|||||||Wilcoxon (Mann-Whitney)|||For MCS only||||0.2486
73910493|NCT03855228|147351102|SUPERIORITY|||||||0.36|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.36
73910494|NCT03855228|147351102|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910495|NCT03855228|147351102|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910496|NCT03855228|147351102|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910497|NCT03855228|147351102|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910498|NCT03855228|147351102|SUPERIORITY|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.02
73910499|NCT03855228|147351103|SUPERIORITY|||||||0.35|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.35
73910500|NCT03855228|147351103|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910501|NCT03855228|147351103|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910502|NCT03855228|147351103|SUPERIORITY|||||||0.03|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.03
73910503|NCT03855228|147351103|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910504|NCT03855228|147351103|SUPERIORITY|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.02
73910505|NCT03855228|147351104|SUPERIORITY|||||||0.77|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.77
73910506|NCT03855228|147351104|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910507|NCT03855228|147351104|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910508|NCT03855228|147351104|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910509|NCT03855228|147351104|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910510|NCT03855228|147351104|SUPERIORITY|||||||0.45|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.45
73910511|NCT03855228|147351105|SUPERIORITY|||||||0.99|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.99
73910512|NCT03855228|147351105|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910513|NCT03855228|147351105|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910514|NCT03855228|147351105|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910515|NCT03855228|147351105|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910516|NCT03855228|147351105|SUPERIORITY|||||||0.08|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.08
73910517|NCT03855228|147351106|SUPERIORITY|||||||0.85|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.85
73910518|NCT03855228|147351106|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910519|NCT03855228|147351106|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910520|NCT03855228|147351106|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910521|NCT03855228|147351106|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910522|NCT03855228|147351106|SUPERIORITY|||||||0.17|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.17
73910523|NCT03855228|147351107|SUPERIORITY|||||||0.88|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.88
73964928|NCT04714320|147465415|SUPERIORITY||||||=|0.775||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 120||||=0.775
73910524|NCT03855228|147351107|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910525|NCT03855228|147351107|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910526|NCT03855228|147351107|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910527|NCT03855228|147351107|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910528|NCT03855228|147351107|SUPERIORITY|||||||0.22|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.22
73910529|NCT03855228|147351108|SUPERIORITY|||||||0.65|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.65
73910530|NCT03855228|147351108|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910531|NCT03855228|147351108|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910532|NCT03855228|147351108|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910533|NCT03855228|147351108|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910534|NCT03855228|147351108|SUPERIORITY|||||||0.92|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.92
73910535|NCT03855228|147351109|SUPERIORITY|||||||0.95|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.95
73964929|NCT04714320|147465415|SUPERIORITY||||||=|0.801||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 148||||=0.801
73910536|NCT03855228|147351109|SUPERIORITY|||||||0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.01
73910537|NCT03855228|147351109|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910538|NCT03855228|147351109|SUPERIORITY|||||||0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.01
73910539|NCT03855228|147351109|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
73910540|NCT03855228|147351109|SUPERIORITY|||||||0.58|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.58
73910541|NCT03855228|147351110|SUPERIORITY|||||||0.29|||||||ANOVA|||||||0.29
73910542|NCT03855228|147351110|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73910543|NCT03855228|147351110|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73964930|NCT04714320|147465415|SUPERIORITY||||||=|0.329||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 148||||=0.329
73964931|NCT04714320|147465415|SUPERIORITY||||||=|0.882||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 169||||=0.882
73964932|NCT04714320|147465415|SUPERIORITY||||||=|0.235||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 169||||=0.235
73964933|NCT04714320|147465415|SUPERIORITY||||||=|0.505||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 8||||=0.505
73910544|NCT03855228|147351110|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73910545|NCT03855228|147351110|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73910546|NCT03855228|147351110|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.80
73910547|NCT03855228|147351111|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
73910548|NCT03855228|147351111|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73910549|NCT03855228|147351111|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73910550|NCT03855228|147351111|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73910551|NCT03855228|147351111|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73910552|NCT03855228|147351111|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
73910553|NCT00667875|147351148|SUPERIORITY|||||||0.49||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model, Group by time (4 time blocks) with an unstructured variance/covariance matrix. Baseline drinks per day was used as a covariate.||||0.49
73910554|NCT00667875|147351149|SUPERIORITY|||||||0.03||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model (SPSS linear mixed) with an unstructured variance/covariance and baseline percent heavy drinking days as a covariate||||0.03
73910555|NCT00667875|147351150|SUPERIORITY|Anova across all three treatment groups|||||<|0.05|||||||ANOVA|Naltrexone or naltrexone placebo pills taken F=3.9 df 2 Aripiprazole or aripiprazole placebo pills taken F=4.6 df 2||||||<.05
73910556|NCT00667875|147351151|SUPERIORITY||||||<|0.05|||||||ANOVA|f 3.2 df 2||Anova across three groups||||<.05
73910557|NCT01696071|147351157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.038|0.034|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 QD - Tio R2.5 BID|No p-values are presented as no formal statistical hypothesis was tested.||0.034|-0.038|
73910558|NCT01696071|147351158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.021||||95.0|-0.032|0.052|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.052|-0.032|
73910559|NCT01696071|147351159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.05|0.022|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.022|-0.050|
73910560|NCT01696071|147351160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.051|0.023|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.023|-0.051|
73910561|NCT01696071|147351161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.032||||95.0|-0.06|0.068|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.068|-0.060|
73910562|NCT01696071|147351162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.044|0.035|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.035|-0.044|
73910563|NCT01696071|147351163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.023||||95.0|-0.048|0.042|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.042|-0.048|
73910564|NCT01696071|147351164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.047|0.034|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.034|-0.047|
73910565|NCT01696071|147351165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.07|0.032|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.032|-0.070|
73910566|NCT01696071|147351166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.035||||95.0|-0.03|0.111|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.111|-0.030|
73910567|NCT01696071|147351167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.389|STANDARD_ERROR_OF_MEAN|3.658||||95.0|-8.651|5.873|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||5.873|-8.651|
74026581|NCT05299892|147606627|OTHER||Mean Difference (Final Values)|6.46153||||0.005|TWO_SIDED|95.0|1.79|12.99|||ANOVA|||An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA .Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE moderate. Analysis of age effects was not completed.||12.99|1.79|.005
73910568|NCT05764408|147351194|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.49|1.35||||||||1.35|0.49|
73910569|NCT05764408|147351195|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.39|1.86||||||||1.86|0.39|
73910570|NCT05764408|147351196|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
73910571|NCT05764408|147351198|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.81
73910572|NCT05764408|147351199|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.07|16.12||||||||16.12|0.07|
73910573|NCT05147428|147351202|SUPERIORITY||Cox Proportional Hazard|0.99||||0.76|TWO_SIDED|95.0|0.94|1.04|||Log Rank|||For the primary analysis, we combined all three targeted medication classes (antipsychotics, sedative/hypnotics, or strong anticholinergics). We calculated Kaplan-Meier curves and performed log-rank testing, and estimated hazard ratios using Cox proportional hazards modeling, censoring at death or disenrollment from the health plan, or at the end of the 6-month study observation period, whichever came first. The index date for the survival analysis was the end of the 3-month blackout period.||1.04|0.94|0.76
74026582|NCT05299892|147606627|OTHER||Mean Difference (Final Values)|9.00961|||<|0.001|TWO_SIDED|95.0|3.91|15.11|||ANOVA|||An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA . Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE strong. An analysis of age effects was not completed.||15.11|3.91|<.001
73910574|NCT05147428|147351203|SUPERIORITY|||||||0.33|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.33
73910575|NCT05147428|147351204|SUPERIORITY|||||||0.55|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.55
73910576|NCT05147428|147351205|SUPERIORITY|||||||0.47|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.47
73910577|NCT05147428|147351206|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
73910578|NCT05147428|147351208|SUPERIORITY|||||||0.19|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.19
73910579|NCT05147428|147351209|SUPERIORITY|||||||0.46|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.46
73910580|NCT05147428|147351210|SUPERIORITY|||||||0.79|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.79
73910581|NCT02468674|147351215|OTHER|||||||0.759|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.759
73910582|NCT02468674|147351215|OTHER|||||||0.5|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.500
73910583|NCT02468674|147351215|OTHER|||||||0.144|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.144
73910584|NCT02468674|147351215|OTHER|||||||0.648|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.648
73910585|NCT02468674|147351215|OTHER|||||||0.929|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.929
73910586|NCT02468674|147351215|OTHER|||||||0.53|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.530
73910587|NCT02468674|147351216|OTHER|||||||0.839|||||||ANCOVA|Difference in the least square means (SE)||Population II: SPPB total score at Week 49||||0.839
73910588|NCT02468674|147351217|OTHER|||||||0.669|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.669
73910589|NCT02468674|147351217|OTHER|||||||0.773|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.773
73910590|NCT02468674|147351217|OTHER|||||||0.29|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.290
73910591|NCT02468674|147351217|OTHER|||||||0.766|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.766
73910592|NCT02468674|147351217|OTHER|||||||0.885|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.885
73964934|NCT04714320|147465415|SUPERIORITY||||||=|0.436||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 8||||=0.436
73910593|NCT02468674|147351217|OTHER|||||||0.84|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.840
73910594|NCT02468674|147351218|OTHER|||||||0.367|||||||ANCOVA|Difference in the least square means (SE)||Population II: 6MWT at Week 49||||0.367
73964935|NCT04714320|147465415|SUPERIORITY||||||=|0.637||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 15||||=0.637
73910595|NCT02468674|147351219|OTHER|||||||0.875|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.875
73910596|NCT02468674|147351219|OTHER|||||||0.909|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.909
73910597|NCT02468674|147351219|OTHER|||||||0.168|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.168
73964936|NCT04714320|147465415|SUPERIORITY||||||=|0.254||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 15||||=0.254
73964937|NCT04714320|147465415|SUPERIORITY||||||=|0.848||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 22||||=0.848
74026583|NCT05299892|147606627|OTHER||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: There will be no significant differences between the mean unaided CNC score at 50 dBA and the mean aided CNC score with SE off.||||<0.001
74026584|NCT03334214|147606630|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
74026585|NCT03334214|147606631|SUPERIORITY|||||||0.026|||||||ANOVA|||||||0.026
73910598|NCT02468674|147351219|OTHER|||||||0.632|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.632
73910599|NCT02468674|147351219|OTHER|||||||0.31|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.310
73910600|NCT02468674|147351219|OTHER|||||||0.321|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.321
73910601|NCT02468674|147351220|OTHER|||||||0.395|||||||ANCOVA|Difference in the least square means (SE)||Population II: Gait speed at Week 49||||0.395
73910602|NCT02468674|147351221|OTHER|||||||0.12|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.120
73910603|NCT02468674|147351221|OTHER|||||||0.297|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.297
73910604|NCT02468674|147351221|OTHER|||||||0.074|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.074
73910605|NCT02468674|147351221|OTHER|||||||0.022|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.022
73910606|NCT02468674|147351221|OTHER|||||||0.106|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.106
73910607|NCT02468674|147351221|OTHER|||||||0.211|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.211
73910608|NCT02468674|147351222|OTHER|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: ASMI at Week 49||||1.000
73910609|NCT02468674|147351223|OTHER|||||||0.084|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.084
73910610|NCT02468674|147351223|OTHER|||||||0.283|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.283
73910611|NCT02468674|147351223|OTHER|||||||0.323|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.323
73910612|NCT02468674|147351223|OTHER|||||||0.018|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.018
73910613|NCT02468674|147351223|OTHER|||||||0.179|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.179
73910614|NCT02468674|147351223|OTHER|||||||0.227|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.227
73910615|NCT02468674|147351224|OTHER|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: LBM at Week 49||||1.000
73910616|NCT03689530|147351243|SUPERIORITY|||||||0.7436|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.7436
73910617|NCT03689530|147351244|SUPERIORITY|||||||0.1212|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1212
73910618|NCT03689530|147351245|SUPERIORITY|||||||0.8839|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.8839
73910619|NCT03689530|147351246|SUPERIORITY|||||||0.1137|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1137
73964938|NCT04714320|147465415|SUPERIORITY||||||=|0.24||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 22||||=0.240
73964939|NCT04714320|147465415|SUPERIORITY||||||=|0.382||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 29||||=0.382
73964940|NCT04714320|147465415|SUPERIORITY||||||=|0.935||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 29||||=0.935
73964941|NCT04714320|147465415|SUPERIORITY||||||=|0.278||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 36||||=0.278
73964942|NCT04714320|147465415|SUPERIORITY||||||=|0.211||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 36||||=0.211
74026586|NCT03334214|147606634|SUPERIORITY|||||||0.024|||||||ANOVA|||||||0.024
73910620|NCT03689530|147351247|SUPERIORITY|||||||0.0162|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.0162
73910621|NCT03689530|147351249|SUPERIORITY|||||||0.2117|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.2117
73910622|NCT03689530|147351250|SUPERIORITY|||||||0.4169|||||||Mixed Models Analysis|||||||0.4169
73910623|NCT03689530|147351251|SUPERIORITY|||||||0.8785|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.8785
73910624|NCT03689530|147351252|SUPERIORITY|||||||0.1006|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1006
73910625|NCT03689530|147351253|SUPERIORITY|||||||0.7168|||||||Mixed Models Analysis|||||||0.7168
73910626|NCT03689530|147351254|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.0001
73910627|NCT03689530|147351255|OTHER|Single group analysis for peer support group only|Mean|3.799|STANDARD_DEVIATION|0.885|||TWO_SIDED|||||||||||||
73910628|NCT03689530|147351256|OTHER|Single group analysis for peer support group only|Mean|3.732|STANDARD_DEVIATION|0.985|||TWO_SIDED|||||||||||||
73910629|NCT03689530|147351257|OTHER|Single group analysis for peer support group only|Mean|6.222|STANDARD_DEVIATION|1.083|||TWO_SIDED|||||||||||||
73910630|NCT03689530|147351258|OTHER|Single group analysis for peer support group only|Mean|6.179|STANDARD_DEVIATION|1.141|||TWO_SIDED|||||||||||||
73910631|NCT03689530|147351259|SUPERIORITY|||||||0.9126|||||||Mixed Models Analysis|||||||0.9126
73964943|NCT04714320|147465415|SUPERIORITY||||||=|0.562||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 43||||=0.562
73964944|NCT04714320|147465415|SUPERIORITY||||||=|0.25||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 43||||=0.250
73964945|NCT04714320|147465415|SUPERIORITY||||||=|0.114||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 50||||=0.114
73964946|NCT04714320|147465415|SUPERIORITY||||||=|0.55||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 50||||=0.550
73964947|NCT04714320|147465415|SUPERIORITY||||||=|0.423||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 57||||=0.423
73964948|NCT04714320|147465415|SUPERIORITY||||||=|0.422||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 57||||=0.422
73964949|NCT04714320|147465415|SUPERIORITY||||||=|0.073||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 64||||=0.073
73910632|NCT03689530|147351260|SUPERIORITY|||||||0.7405|||||||Mixed Models Analysis|||||||0.7405
73910633|NCT03689530|147351261|SUPERIORITY|||||||0.5956|||||||Mixed Models Analysis|||||||0.5956
73910634|NCT03689530|147351262|SUPERIORITY|||||||0.3341|||||||Mixed Models Analysis|||||||0.3341
73910635|NCT03689530|147351263|SUPERIORITY|||||||0.2049|||||||Mixed Models Analysis|||||||0.2049
73910636|NCT03689530|147351264|SUPERIORITY|||||||0.0335|||||||Mixed Models Analysis|||||||0.0335
73910637|NCT03689530|147351265|SUPERIORITY|||||||0.3219|||||||Mixed Models Analysis|||||||0.3219
73910638|NCT03689530|147351266|SUPERIORITY|||||||0.5223|||||||Mixed Models Analysis|||||||0.5223
73910639|NCT04622306|147351289|NON_INFERIORITY|The non-inferiority margin for the difference in total clinical failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified in ISO 23409:2011 as 2.5%.|Upper 97.5% CL for difference|2.5||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set.|GEE|||Null Hypothesis: Expected test condom total clinical failure rate - expected control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.||2.5||0.025
73910640|NCT04622306|147351289|NON_INFERIORITY|The non-inferiority margin for the difference in total failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified on ISO 23409:2011 as 2.5%|Upper 97.5% CLof difference|2.5||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set.|GEE|||Null Hypothesis: Test condom total clinical failure rate - control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.||2.5||0.025
73910641|NCT04622306|147351289|NON_INFERIORITY|The non-inferiority margin for the difference in total failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified on ISO 23409:2011 as 2.5%|Upper 97.5% CL for difference|2.37||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set|GEE|||The non-inferiority analysis was repeated after removing couples where the male partner had a penis length greater than 170 mm. The polyurethane condom B has a specified nominal length of 170 mm and is not recommended for men with penises longer than the length of the condom.||2.5||0.025
73910642|NCT01601132|147351311|SUPERIORITY_OR_OTHER|||||||0.5663||||||Significant difference defined a priori as p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.5663
73910643|NCT01601132|147351312|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|105.86|||||TWO_SIDED|90.0|101.77|110.12|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Cmax, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Cmax to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, (AUC0-∞), and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||110.12|101.77|
73910644|NCT01601132|147351313|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|105.63|||||TWO_SIDED|90.0|101.81|109.59|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-t)\], expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-t) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||109.59|101.81|
73910645|NCT01601132|147351314|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|106.43|||||TWO_SIDED|90.0|101.1|112.04|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-∞) , expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-∞) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||112.04|101.10|
73910646|NCT01601132|147351315|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|93.96|||||TWO_SIDED|90.0|89.25|98.92|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed CL/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed CL/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||98.92|89.25|
73910647|NCT01601132|147351316|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|98.59|||||TWO_SIDED|90.0|90.97|106.85|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Vd/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Vd/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||106.85|90.97|
73964950|NCT04714320|147465415|SUPERIORITY||||||=|0.278||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 64||||=0.278
73910648|NCT01952145|147351333|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of IDegLira versus IGlar was considered as confirmed, if the 95% confidence interval (CI) for the mean treatment difference was entirely below 0.30%.|Treatment contrast|-0.59|||<|0.001|TWO_SIDED|95.0|-0.74|-0.45|||ANCOVA|||This primary endpoint was analysed on the FAS using an ANCOVA model with treatment and region as fixed effects and baseline HbA1c value as covariate.||-0.45|-0.74|< 0.001
73910649|NCT04138810|147351337|NON_INFERIORITY|We defined the non-inferiority margin to be 5 points which with a sample of size of 25 women per arm would mean we would have a type I error rate of 0.05 and a power of 0.80.|Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|-1.95|1.03||||||||1.03|-1.95|
73910650|NCT05280782|147351342|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Systolic Blood Pressure values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Systolic Blood Pressure values were normal.|||
73910651|NCT05280782|147351342|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Diastolic Blood Pressure values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Diastolic Blood Pressure values were normal.|||
73910652|NCT05280782|147351343|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Heart Rate values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Heart Rate values were normal.|||
73964951|NCT04714320|147465415|SUPERIORITY||||||=|0.338||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 71||||=0.338
74026587|NCT03334214|147606635|SUPERIORITY|||||||0.0774|||||||Cochran-Mantel-Haenszel|The p-value is obtained using Cochran-Mantel-Haenszel (CMH) test stratified by the baseline liver fat stratum (\<20%, ≥20%) stratification factor.||||||0.0774
74026588|NCT03334214|147606636|SUPERIORITY|||||||0.183|||||||ANOVA|||||||0.183
74026589|NCT03334214|147606637|SUPERIORITY|||||||0.682|||||||ANOVA|||Total Cholesterol||||0.682
73910653|NCT05280782|147351344|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Respiratory Rate values. The values were categorized as Normal or Abnormal.||||||0.016||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.016
73910654|NCT05280782|147351345|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Temperature values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Temperature values were normal.|||
73910655|NCT05280782|147351346|EQUIVALENCE|A McNemar test was performed between baseline and post-injection EKG. The outcomes were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the EKGs were normal.|||
73910656|NCT05280782|147351347|EQUIVALENCE|A McNemar test was performed between baseline and post-injection EKG. The outcomes were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the EKGs were normal.|||
73910657|NCT05280782|147351348|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Sodium values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Sodium values were normal.|||
73910658|NCT05280782|147351348|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Potassium values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Potassium values were normal.|||
73910659|NCT05280782|147351348|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Chloride values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Chloride values were normal.|||
73910660|NCT05280782|147351348|EQUIVALENCE|A McNemar test was performed between baseline and post-injection CO2 values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
73910661|NCT05280782|147351349|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Glucose values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
73910662|NCT05280782|147351349|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Calcium values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
73964952|NCT04714320|147465415|SUPERIORITY||||||=|0.969||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 71||||=0.969
73964953|NCT04714320|147465415|SUPERIORITY||||||=|0.489||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 78||||=0.489
74026590|NCT03334214|147606637|SUPERIORITY|||||||0.716|||||||ANOVA|||ApoB||||0.716
74026591|NCT03334214|147606637|SUPERIORITY|||||||0.717|||||||ANOVA|||HDL||||0.717
74026592|NCT03334214|147606637|SUPERIORITY|||||||0.463|||||||ANOVA|||LDL-C||||0.463
74026593|NCT03334214|147606637|SUPERIORITY|||||||0.555|||||||ANOVA|||Non-HDL||||0.555
74026594|NCT03334214|147606637|SUPERIORITY|||||||0.619|||||||ANOVA|||Triglycerides||||0.619
74026595|NCT03334214|147606637|SUPERIORITY|||||||0.698|||||||ANOVA|||VLDL-C||||0.698
74026596|NCT03334214|147606638|SUPERIORITY|||||||0.902|||||||ANOVA|||FPG||||0.902
74026597|NCT03334214|147606638|SUPERIORITY|||||||0.267|||||||Van Elteren test|||HOMA-IR||||0.267
74026598|NCT03334214|147606638|SUPERIORITY|||||||0.2|||||||Van Elteren test|||Insulin||||0.200
73910663|NCT05280782|147351349|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Creatinine values. The values were categorized as Normal or Abnormal.||||||0.453||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.453
73910664|NCT05280782|147351349|EQUIVALENCE|A McNemar test was performed between baseline and post-injection BUN values. The values were categorized as Normal or Abnormal.||||||0.125||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.125
73910665|NCT05280782|147351349|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Total Bilirubin values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
73910666|NCT05280782|147351350|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Total Protein values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Total Protein values were normal.|||
73910667|NCT05280782|147351350|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Albumin values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
73910668|NCT05280782|147351351|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Alkaline Phosphatase values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Alkaline Phosphatase values were normal.|||
73910669|NCT05280782|147351351|EQUIVALENCE|A McNemar test was performed between baseline and post-injection ALT values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
73910670|NCT05280782|147351351|EQUIVALENCE|A McNemar test was performed between baseline and post-injection AST values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the AST values were normal.|||
73910671|NCT05280782|147351352|EQUIVALENCE|A McNemar test was performed between baseline and post-injection WBC values. The values were categorized as Normal or Abnormal.||||||0.687||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.687
73910672|NCT05280782|147351353|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Hemoglobin values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
73910673|NCT05280782|147351354|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Hematocrit values. The values were categorized as Normal or Abnormal.||||||1||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||1.000
73910674|NCT05280782|147351355|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Platelets values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Platelets values were normal.|||
73910675|NCT05280782|147351356|EQUIVALENCE|A McNemar test was performed between baseline and post-injection RBC values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
73910676|NCT05280782|147351357|EQUIVALENCE|A McNemar test was performed between baseline and post-injection MCV values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the MCV values were normal.|||
73910677|NCT04545060|147351365|SUPERIORITY||adjusted relative risk ratio|0.21|||<|0.001|TWO_SIDED|95.0|0.09|0.5||two-sided, alpha=0.05|poisson regression model|||||0.50|0.09|<0.001
73910678|NCT04545060|147351383|SUPERIORITY||relative risk ratio|0.34|||<|0.001|TWO_SIDED|95.0|0.19|0.63||two-sided, alpha=0.05|poisson regression model|||||0.63|0.19|<0.001
73910679|NCT04545060|147351384|SUPERIORITY||Least squares mean difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.38|-0.76||two-sided, alpha=0.05|ANCOVA|||||-0.76|-1.38|<0.001
73910680|NCT04545060|147351386|SUPERIORITY||Least squares mean difference|-0.232||||0.007|TWO_SIDED|95.0|-0.399|-0.065||two-sided, alpha=0.05|Mixed model repeated measures|||||-0.065|-0.399|0.007
73910681|NCT04545060|147351390|SUPERIORITY||relative risk ratio|0.26||||0.002|TWO_SIDED|95.0|0.12|0.59||two-sided, alpha=0.05|poisson regression model|||||0.59|0.12|0.002
73910682|NCT02068027|147351476|SUPERIORITY|||||||0.4503||||||MMRM imputing for missing data|Mixed Models Analysis|||||||0.4503
73910683|NCT02068027|147351477|SUPERIORITY|||||||0.735||||||MMRM imputing for missing data|Mixed Models Analysis|||||||0.7350
73910684|NCT01032174|147351479|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic|||||||<0.0001
73910685|NCT01032174|147351480|SUPERIORITY_OR_OTHER||Difference of Least Square Mean|1.06|STANDARD_ERROR_OF_MEAN|0.55||0.0568|TWO_SIDED|95.0|-0.03|2.15||The analysis of covariance (ANCOVA) model contained terms for treatment, gender, age and Body Mass Index (BMI).|ANCOVA|Least square mean was adjusted for gender, age and BMI.||||2.15|-0.03|0.0568
73910686|NCT01032174|147351481|SUPERIORITY_OR_OTHER|||||||0.0682|TWO_SIDED|||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic|||||||0.0682
73910687|NCT00702689|147351485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|||||||Paired t-test|||||||.011
73910688|NCT00702689|147351487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||t-test, 2 sided|||||||.47
73910689|NCT00702689|147351488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||t-test, 2 sided|||||||.29
73910690|NCT02761733|147351531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3652||||0.0679|TWO_SIDED|95.0|-6.9559|0.2255||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173|||.2255|-6.9559|.0679
73910691|NCT02761733|147351531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.882||||0.0999|TWO_SIDED|95.0|-6.2957|0.5317||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165|||0.5317|-6.2957|.0999
74026599|NCT03334214|147606639|SUPERIORITY|||||||0.933|||||||ANOVA|||||||0.933
74026600|NCT00736229|147606676|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison for the difference in Median glucose values during steady state across all three groups.|Kruskal-Wallis|||Median Glucose Values (mg/dl) after steady state were evaluated across the three groups (Exenatide,Moderate and Intensive) with a Kruskal-Wallis test.||||<0.001
74085345|NCT03566238|147724397|SUPERIORITY||proportion difference|0.435||||0.0015|TWO_SIDED|95.0|0.2195|0.6551|||Cochran-Mantel-Haenszel|||"Analysis was based on the Cochran Mantel Haenszel test adjusting PFIC type. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."||0.6551|0.2195|0.0015
74085346|NCT03566238|147724397|SUPERIORITY||proportion difference|0.211||||0.0174|TWO_SIDED|95.0|0.021|0.4557|||Cochran-Mantel-Haenszel|||Analysis was based on the Cochran Mantel Haenszel test adjusting PFIC type. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses. One-sided adjusted p-value was reported.||0.4557|0.021|0.0174
74085347|NCT00127166|147724417|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-3.25||||0.009||95.0|-5.66|-0.84|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period||||-0.84|-5.66|0.009
74085348|NCT00127166|147724418|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-52.71||||0.006||95.0|-89.76|-15.66|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.||||-15.66|-89.76|0.006
74085349|NCT00127166|147724419|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.11|||<|0.001||95.0|2.58|5.64|||ANCOVA|Participant, treatment, period \& covariate for FEV1 %-predicted Treatment test is adjusted for period \& FEV1 %-predicted at pre-exercise baseline||||5.64|2.58|<0.001
73964954|NCT04714320|147465415|SUPERIORITY||||||=|0.156||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 78||||=0.156
73964955|NCT04714320|147465415|SUPERIORITY||||||=|0.389||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 85||||=0.389
73964956|NCT04714320|147465415|SUPERIORITY||||||=|0.775||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 85||||=0.775
73964957|NCT04714320|147465415|SUPERIORITY||||||=|0.437||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 92||||=0.437
73964958|NCT04714320|147465415|SUPERIORITY||||||=|0.618|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 92||||=0.618
73964959|NCT04714320|147465415|SUPERIORITY||||||=|0.079||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 106||||=0.079
73964960|NCT04714320|147465415|SUPERIORITY||||||=|0.349||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 106||||=0.349
73964961|NCT04714320|147465415|SUPERIORITY||||||=|0.58||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 120||||=0.580
73964962|NCT04714320|147465415|SUPERIORITY||||||=|0.106||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 120||||=0.106
73964963|NCT04714320|147465415|SUPERIORITY||||||=|0.955||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 148||||=0.955
73964964|NCT04714320|147465415|SUPERIORITY||||||=|0.134||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 148||||=0.134
73964965|NCT04714320|147465415|SUPERIORITY||||||=|0.933||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 169||||=0.933
73964966|NCT04714320|147465415|SUPERIORITY||||||=|0.502||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 169||||=0.502
73964967|NCT04714320|147465415|SUPERIORITY||||||=|0.653||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 8||||=0.653
73964968|NCT04714320|147465415|SUPERIORITY||||||=|0.816||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 8||||=0.816
73910692|NCT02761733|147351531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0139||||0.5588|TWO_SIDED|95.0|-4.4957|2.3779||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 148|||2.3779|-4.4957|.5588
73910693|NCT02761733|147351531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2798||||0.8532|TWO_SIDED|95.0|-2.6771|3.2367||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 136|||3.2367|-2.6771|.8532
73910694|NCT02761733|147351532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4524||||0.0988|TWO_SIDED|95.0|-7.5302|0.6254||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 180|||0.6254|-7.5302|.0988
73910695|NCT02761733|147351532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3087||||0.876|TWO_SIDED|95.0|-4.1799|3.5625||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 166|||3.5625|-4.1799|.8760
73910696|NCT02761733|147351532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.541||||0.1878|TWO_SIDED|95.0|-1.2234|6.3054||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 153|||6.3054|-1.2234|.1878
73910697|NCT02761733|147351532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6237||||0.333|TWO_SIDED|95.0|-4.9|1.6526||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 143|||1.6526|-4.9000|.3330
73910698|NCT02761733|147351533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9284||||0.6588|TWO_SIDED|95.0|-10.4728|6.616||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 175|||6.6160|-10.4728|.6588
73910699|NCT02761733|147351533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3959||||0.2633|TWO_SIDED|95.0|-2.2237|11.0155||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 169||a priori test||11.0155|-2.2237|.2633
73910700|NCT02761733|147351533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9703||||0.0343|TWO_SIDED|95.0|-17.2107|-0.7299||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 166|Satterthwaite adjusted df = 166|a priori test||-0.7299|-17.2107|.0343
73910701|NCT02761733|147351533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.7297||||0.3126|TWO_SIDED|95.0|-3.4864|10.9458||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis||Satterthwaite adjusted df = 163|a priori test||10.9458|-3.4864|.3126
73910702|NCT02761733|147351534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1241||||0.584|TWO_SIDED|95.0|-0.5675|0.3193||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 142|||.3193|-.5675|.5840
73910703|NCT02761733|147351534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2642||||0.2404|TWO_SIDED|95.0|-0.1754|0.7038||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 184|||.7038|-.1754|.2404
73910704|NCT02761733|147351534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3192||||0.1074|TWO_SIDED|95.0|-0.0667|0.7051||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 129|||.7051|-.0667|.1074
73910705|NCT02761733|147351534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0576||||0.7677|TWO_SIDED|95.0|-0.3238|0.439||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 131|||.4390|-.3238|.7677
73910706|NCT02761733|147351535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.026||||0.9046|TWO_SIDED|95.0|-0.4507|0.3987||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 182|||.3987|-.4507|.9046
73910707|NCT02761733|147351535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2258||||0.2518|TWO_SIDED|95.0|-0.1591|0.6107||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173|||.6107|-.1591|.2518
73910708|NCT02761733|147351535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.437||||0.0338|TWO_SIDED|95.0|-0.837|-0.037||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165|||-.0370|-.8370|.0338
73910709|NCT02761733|147351535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2564||||0.1555|TWO_SIDED|95.0|-0.6086|0.0958||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 157|||.0958|-.6086|.1555
73910710|NCT02761733|147351536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2967||||0.0283|TWO_SIDED|95.0|-0.5599|-0.0335||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 213|||-.0335|-.5599|.0283
73910711|NCT02761733|147351536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0401||||0.7407|TWO_SIDED|95.0|-0.1969|0.2771||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 194|||.2771|-.1969|.7407
73910712|NCT02761733|147351536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2338||||0.0619|TWO_SIDED|95.0|-0.4778|0.0102||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 186|||.0102|-.4778|.0619
73910713|NCT02761733|147351536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3793||||0.0009|TWO_SIDED|95.0|-0.599|-0.1596||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 172|||-.1596|-.5990|.0009
73910714|NCT01961362|147351544|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_DEVIATION|0.87||0.6|TWO_SIDED|||||P\<0.05 considered to represent statistical significance.|t-test, 2 sided|||||||0.6
73910715|NCT01961362|147351544|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
73910716|NCT01961362|147351545|SUPERIORITY||Median Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
73910717|NCT02149719|147351547|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73910718|NCT01761175|147351555|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
73910719|NCT01761175|147351556|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
73910720|NCT01761175|147351557|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
73910721|NCT01761175|147351558|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
73910722|NCT01761175|147351559|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
73910723|NCT01761175|147351560|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73964969|NCT04714320|147465415|SUPERIORITY||||||=|0.184||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 15||||=0.184
73964970|NCT04714320|147465415|SUPERIORITY||||||=|0.765||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 15||||=0.765
73964971|NCT04714320|147465415|SUPERIORITY||||||=|0.009||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 22||||=0.009
73964972|NCT04714320|147465415|SUPERIORITY||||||=|0.578||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 22||||=0.578
73964973|NCT04714320|147465415|SUPERIORITY||||||=|0.725||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 29||||=0.725
73964974|NCT04714320|147465415|SUPERIORITY||||||=|0.287||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 29||||=0.287
73964975|NCT04714320|147465415|SUPERIORITY||||||=|0.705||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 36||||=0.705
73964976|NCT04714320|147465415|SUPERIORITY||||||=|0.975||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 36||||=0.975
73964977|NCT04714320|147465415|SUPERIORITY||||||=|0.118||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 43||||=0.118
73964978|NCT04714320|147465415|SUPERIORITY||||||=|0.959||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 43||||=0.959
73910724|NCT01761175|147351561|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
73910725|NCT03576495|147351596|SUPERIORITY|"We conducted a superiority statistical test to assess if residents' knowledge improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident knowledge, resident knowledge was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."|Mean Difference (Final Values)|2.6||||0.2422|TWO_SIDED|||||This p-value compares the average scores (in percent) of the residents' knowledge assessment at time period 2 between the Early Intervention and Delayed Intervention groups.|t-test, 2 sided|||||||0.2422
73910726|NCT03576495|147351597|SUPERIORITY||Difference between percentage|0.0||||1|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' preparation for caring for culturally diverse patients improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident preparedness assessed by the Cross-Cultural Care Survey, resident preparedness was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||1.000
73910727|NCT03576495|147351598|SUPERIORITY||Percent difference|0.9||||0.6295|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' self-assessed skills improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident skills, resident skills were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||0.6295
73910728|NCT03576495|147351599|SUPERIORITY||Difference between percentage|2.5||||0.0199|TWO_SIDED||||||Fisher Exact|||"We conducted a superiority statistical test to assess if residents' beliefs improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident beliefs, beliefs were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||0.0199
73964979|NCT04714320|147465415|SUPERIORITY||||||=|0.413||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 50||||=0.413
73964980|NCT04714320|147465415|SUPERIORITY||||||=|0.043||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 50||||=0.043
73910729|NCT03576495|147351600|SUPERIORITY||difference in the percentage|2.2||||0.2665|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Limited English Proficiency and Informed Consent OSCE."||||0.2665
73910730|NCT03576495|147351600|SUPERIORITY||difference in the percentage|6.2||||0.0001|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Trust and Pain."||||0.0001
73910731|NCT03576495|147351601|SUPERIORITY||absolute difference between percentage|3.19||||0.5079|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to trust at time period 2."||||0.5079
73910732|NCT03576495|147351601|SUPERIORITY||absolute difference between percentage|1.92||||0.1571|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the curriculum, patient satisfaction was compared at Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to limited English proficiency at period 2."||||0.1571
73910733|NCT03576495|147351601|SUPERIORITY||absolute difference between percentage|4.76||||0.0001|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to consent at time period 2."||||0.0001
73910734|NCT03576495|147351601|SUPERIORITY||absolute difference between percentage|0.19||||0.2956|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to pain at time period 2."||||0.2956
73910735|NCT03576495|147351602|SUPERIORITY||Cox Proportional Hazard|5.31||||0.0028|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||We used Cox Proportional Hazard to assess time to discharge, with 5.31 days as the estimated value for the difference between the two groups.|"We conducted a superiority statistical test to assess if patients length of stay improved after resident exposure to the PACTS curriculum. Patient length of stay was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups to measure an effect of the PACTS intervention."||||0.0028
73910736|NCT01903031|147351632|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.||||<0.001
73910737|NCT01903031|147351632|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.||||<0.001
73910738|NCT01903031|147351633|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.||||<0.001
73910739|NCT01903031|147351633|OTHER|||||||0.004||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.||||0.004
73910740|NCT03407625|147351681|SUPERIORITY||Risk Ratio (RR)|1.0||||0.86|TWO_SIDED|95.0|0.95|1.05|||log binomial regression||||We used generalized estimating equations for the log binomial regression with cluster entered as a random effect.|1.05|0.95|0.86
73910741|NCT02197273|147351705|SUPERIORITY_OR_OTHER|||||||0.764|||||||Wilcoxon (Mann-Whitney)|||||||0.764
73910742|NCT02197273|147351706|SUPERIORITY_OR_OTHER|||||||0.206|||||||Wilcoxon (Mann-Whitney)|||||||0.206
73910743|NCT02197273|147351707|SUPERIORITY_OR_OTHER||Fisher exact|0.486||||0.656|TWO_SIDED||||||Fisher Exact|||||||0.656
73910744|NCT04154930|147351708|SUPERIORITY||Treatment difference|69.7|||<|0.001|TWO_SIDED|95.0|52.54|86.89|||Cochran-Mantel-Haenszel|||||86.89|52.54|<0.001
73910745|NCT04154930|147351709|SUPERIORITY||Treatment difference|72.5|||<|0.001|TWO_SIDED|95.0|60.67|84.28|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 6 Months After Baseline||84.28|60.67|<0.001
73910746|NCT04154930|147351709|SUPERIORITY||Treatment difference|66.4|||<|0.001|TWO_SIDED|95.0|54.97|77.92|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 9 Months After Baseline||77.92|54.97|<0.001
73910747|NCT04154930|147351709|SUPERIORITY||Treatment difference|52.4|||<|0.001|TWO_SIDED|95.0|40.57|64.26|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 12 Months After Baseline||64.26|40.57|<0.001
73910748|NCT03104543|147351718|SUPERIORITY||Risk Ratio (RR)|0.99||||0.05|TWO_SIDED|95.0|0.67|1.45|||Generalized estimating equation|||||1.45|0.67|.05
73910749|NCT03104543|147351721|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.05|TWO_SIDED|95.0|-0.47|0.28|||t-test, 2 sided|||||0.28|-0.47|.05
73910750|NCT00806351|147351742|SUPERIORITY_OR_OTHER||Risk Difference|-27.3|||||TWO_SIDED|95.0|-80.9|40.3||||||The 95 percent confidence interval (95% CI) was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||40.3|-80.9|
74026601|NCT00736229|147606676|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison of Median Glucose Values between Exenatide and Intensive Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.||||<0.001
74026602|NCT00736229|147606676|SUPERIORITY_OR_OTHER|||||||0.15||||||Comparison of Median Glucose Values between Exenatide and Moderate Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.||||0.15
73910751|NCT00806351|147351743|SUPERIORITY_OR_OTHER||Risk Difference|-27.3|||||TWO_SIDED|95.0|-80.9|40.3||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||40.3|-80.9|
73910752|NCT00806351|147351744|SUPERIORITY_OR_OTHER||Risk Difference|-40.0|||||TWO_SIDED|95.0|-97.5|63.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||63.9|-97.5|
73910753|NCT00806351|147351745|SUPERIORITY_OR_OTHER||Risk Difference|-50.0|||||TWO_SIDED|95.0|-97.5|55.0||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||55.0|-97.5|
73910754|NCT00806351|147351750|SUPERIORITY_OR_OTHER||Risk Difference|-36.4|||||TWO_SIDED|95.0|-90.6|31.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||31.9|-90.6|
73910755|NCT00134030|147351756|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.214|TWO_SIDED|95.0|0.61|1.12|||Log Rank|||||1.12|0.61|0.214
74085350|NCT00127166|147724420|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.26||||0.035||95.0|1.02|1.55|||Cox Proportional Hazards Model|Model terms: treatment and period|Dispersion not applicable to time to event data|||1.55|1.02|0.035
74085351|NCT00127166|147724421|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.8|||<|0.001||95.0|2.28|5.32|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.||||5.32|2.28|<0.001
74085352|NCT04718129|147724449|SUPERIORITY||Mean Difference (Net)|0.044|STANDARD_ERROR_OF_MEAN|0.021||0.048|TWO_SIDED|95.0|0.003|0.085|||Regression, Linear|||||.085|.003|.048
73910756|NCT00134030|147351756|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.86|TWO_SIDED|95.0|0.78|1.23|||Log Rank|||||1.23|0.78|0.86
73910757|NCT00134030|147351756|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.69|TWO_SIDED|95.0|-3.3|4.9|||Difference in RMST|||Secondary RMST analysis performed in poor response group, due to evidence of non-proportional hazards.||4.9|-3.3|0.69
73910758|NCT00134030|147351757|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.804|TWO_SIDED|95.0|0.69|1.33|||Log Rank|||||1.33|0.69|0.804
73910759|NCT00134030|147351757|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.674|TWO_SIDED|95.0|0.81|1.39|||Log Rank|||||1.39|0.81|0.674
73910760|NCT01435603|147351761|SUPERIORITY||Slope|-1.273||||0.017|TWO_SIDED||||||Regression, Linear|||||||0.017
73910761|NCT01682954|147351770|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
73910762|NCT01682954|147351771|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
73910763|NCT04680052|147351787|SUPERIORITY||Hazard Ratio (HR)|0.434|||<|0.0001|TWO_SIDED|95.0|0.324|0.58|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.580|0.324|<0.0001
73910764|NCT04680052|147351789|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.383|0.653|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.653|0.383|<0.0001
73910765|NCT04680052|147351790|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0286|TWO_SIDED|95.0|1.04|2.13|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.13|1.04|0.0286
73910766|NCT04680052|147351792|SUPERIORITY||Hazard Ratio (HR)|0.587||||0.1061|TWO_SIDED|95.0|0.306|1.128|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||1.128|0.306|0.1061
73910767|NCT04680052|147351793|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.5||||0.0221|TWO_SIDED|95.0|1.06|2.03|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.03|1.06|0.0221
73910768|NCT04680052|147351794|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.4||||0.4093|TWO_SIDED|95.0|0.61|3.33|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.33|0.61|0.4093
74026603|NCT00736229|147606677|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Median Time (Hrs) to steady state was evaluated across the three groups (exenatide, moderate and intensive) with a Kruskal-Wallis test.||||<0.001
74026604|NCT00736229|147606677|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.||||0.80
74085353|NCT01835548|147724455|SUPERIORITY||Least Square Mean Difference|-11.04|STANDARD_ERROR_OF_MEAN|1.4239|<|0.0001|TWO_SIDED|95.0|-13.9|-8.2|||ANCOVA|||||-8.20|-13.9|<0.0001
74085354|NCT00243152|147724482|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Visual analog scale (VAS) ratings in the scanner. Measures of pain ratings to evoked stimuli during scanning for heat applied to the affected side.||||<0.05
74085355|NCT00243152|147724482|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for heat applied to the unaffected side.||||>0.05
73910769|NCT04680052|147351795|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.5||||0.2874|TWO_SIDED|95.0|0.69|3.47|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.47|0.69|0.2874
73910770|NCT04680052|147351796|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.0||||0.0014|TWO_SIDED|95.0|1.3|3.02|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.02|1.30|0.0014
73910771|NCT04680052|147351797|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.29|2.74|||Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.74|1.29|0.0009
73910772|NCT04680052|147351799|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.473|||<|0.0001|TWO_SIDED|95.0|0.33|0.678|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.678|0.330|<0.0001
73910773|NCT04680052|147351801|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.55||||0.0003|TWO_SIDED|95.0|0.397|0.763|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.763|0.397|0.0003
73910774|NCT04680052|147351803|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.85||||0.5837|TWO_SIDED|95.0|0.476|1.519|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||1.519|0.476|0.5837
73964981|NCT04714320|147465415|SUPERIORITY||||||=|0.849||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 57||||=0.849
73964982|NCT04714320|147465415|SUPERIORITY||||||=|0.662||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 57||||=0.662
73964983|NCT04714320|147465415|SUPERIORITY||||||=|0.047||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 64||||=0.047
73964984|NCT04714320|147465415|SUPERIORITY||||||=|0.95||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 64||||=0.950
73910775|NCT04680052|147351805|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.407|||<|0.0001|TWO_SIDED|95.0|0.294|0.563|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.563|0.294|<0.0001
73910776|NCT04680052|147351807|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.357|0.647|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.647|0.357|<0.0001
73910777|NCT04680052|147351808|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.2||||0.0003|TWO_SIDED|95.0|1.43|3.43|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.43|1.43|0.0003
73964985|NCT04714320|147465415|SUPERIORITY||||||=|0.656||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 71||||=0.656
73964986|NCT04714320|147465415|SUPERIORITY||||||=|0.922||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 71||||=0.922
73910778|NCT04680052|147351809|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.0||||0.0005|TWO_SIDED|95.0|1.33|2.86|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.86|1.33|0.0005
73910779|NCT04680052|147351811|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.461|||<|0.0001|TWO_SIDED|95.0|0.312|0.681|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.681|0.312|<0.0001
73910780|NCT04680052|147351813|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|1.192||||0.7469|TWO_SIDED|95.0|0.409|3.475|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||3.475|0.409|0.7469
73964987|NCT04714320|147465415|SUPERIORITY||||||=|0.143||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 78||||=0.143
73964988|NCT04714320|147465415|SUPERIORITY||||||=|0.452||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 78||||=0.452
73910781|NCT03320057|147351827|OTHER|We conducted multivariable logistic regression analyses using Generalized Estimating Equation (GEE) models to assess whether study implementation was associated with pharmacists' overall medication abortion knowledge. Multivariable GEE analyses included time period (baseline and endline) as the primary independent variable, adjusted for gender and years of experience, and accounted for clustering by pharmacy site and individual pharmacist.|Beta Coefficient|0.14|||<|0.05|TWO_SIDED|95.0|0.11|0.17|||Regression, Linear||Coefficients in adjusted analyses examining overall medication abortion knowledge represent the difference in mean knowledge scores between baseline and endline.|Medication abortion knowledge scores were based on a set of 15 items. We first assessed the internal consistency reliability of the 15 knowledge items and considered a Cronbach's alpha coefficient above .70 to be acceptable to examine the items as a combined score.||0.17|0.11|<0.05
73910782|NCT06956170|147351828|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.1|2.78|||||Hazard ratio was estimated using an unstratified Cox Proportional Hazard model with treatment arm as an explanatory variable.|||2.78|0.10|
73910783|NCT01650844|147351872|OTHER|We estimated the power to detect the smallest clinically significant difference in mean SFDs post intervention between the groups, accounting for repeated measures. A sample of 400 obtains greater than 90% power to detect a difference of 0.8 SFD per 2 weeks or greater. Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Mean Difference (Net)|0.8|STANDARD_DEVIATION|2.8|<|0.05|TWO_SIDED|||||Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Regression, Linear|||||||<0.05
73910784|NCT00316719|147351873|NON_INFERIORITY_OR_EQUIVALENCE|This is a Non-inferiority Analysis with the margin of -1.0.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.309|<|0.001||95.0|-0.94|0.28|||ANCOVA|||||0.28|-0.94|<0.001
73910785|NCT02400333|147351893|SUPERIORITY_OR_OTHER||Geometric mean ratio|84.85|||||TWO_SIDED|90.0|76.77|93.78||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||93.78|76.77|
73910786|NCT02400333|147351893|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.61|||||TWO_SIDED|95.0|88.22|105.79||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||105.79|88.22|
73910787|NCT02400333|147351893|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.16|||||TWO_SIDED|95.0|85.59|99.25||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||99.25|85.59|
73910788|NCT02400333|147351893|SUPERIORITY_OR_OTHER||Geometric mean ratio|89.84|||||TWO_SIDED|95.0|82.03|98.39||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.39|82.03|
73910789|NCT02400333|147351893|SUPERIORITY_OR_OTHER||Geometric mean ratio|97.45|||||TWO_SIDED|95.0|90.53|104.9||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||104.90|90.53|
73910790|NCT02400333|147351893|SUPERIORITY_OR_OTHER||Geometric mean ratio|97.07|||||TWO_SIDED|95.0|90.83|103.74||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||103.74|90.83|
73910791|NCT02400333|147351894|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.04|||||TWO_SIDED|95.0|90.33|99.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||99.99|90.33|
73910792|NCT02400333|147351894|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.41|||||TWO_SIDED|95.0|89.94|101.21||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||101.21|89.94|
73910793|NCT02400333|147351894|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.66|||||TWO_SIDED|95.0|90.53|98.98||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||98.98|90.53|
73964989|NCT04714320|147465415|SUPERIORITY||||||=|0.231||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 85||||=0.231
73964990|NCT04714320|147465415|SUPERIORITY||||||=|0.405||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 85||||=0.405
73910794|NCT02400333|147351894|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.67|||||TWO_SIDED|95.0|90.94|98.56||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.56|90.94|
73910795|NCT02400333|147351894|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.0|||||TWO_SIDED|95.0|91.87|100.33||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||100.33|91.87|
73964991|NCT04714320|147465415|SUPERIORITY||||||=|0.718||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 92||||=0.718
74026605|NCT00736229|147606677|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.||||<0.001
74026606|NCT02723630|147606684|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|100.52||||0.8826|TWO_SIDED|90.0|94.84|106.53||P-value for the formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.53|94.84|0.8826
73910796|NCT02400333|147351894|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.56|||||TWO_SIDED|95.0|93.08|100.17||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||100.17|93.08|
73910797|NCT02400333|147351895|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.96|||||TWO_SIDED|95.0|90.27|99.89||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||99.89|90.27|
73910798|NCT02400333|147351895|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.24|||||TWO_SIDED|95.0|89.81|100.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||100.99|89.81|
73910799|NCT02400333|147351895|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.4|||||TWO_SIDED|95.0|90.26|98.73||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||98.73|90.26|
74026607|NCT02723630|147606684|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|96.03||||0.1095|TWO_SIDED|90.0|92.11|100.12||P-value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||100.12|92.11|0.1095
74026608|NCT02723630|147606685|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|100.8||||0.8121|TWO_SIDED|90.0|95.31|106.61||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.61|95.31|0.8121
74085356|NCT00243152|147724482|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the affected side.||||>0.05
74085357|NCT00243152|147724482|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the unaffected side.||||>0.05
74085358|NCT00243152|147724482|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the affected side.||||>0.05
73910800|NCT02400333|147351895|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.82|||||TWO_SIDED|95.0|91.36|98.42||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.42|91.36|
73910801|NCT02400333|147351895|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.71|||||TWO_SIDED|95.0|91.78|99.82||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||99.82|91.78|
73910802|NCT02400333|147351895|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.5|||||TWO_SIDED|95.0|93.26|99.87||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||99.87|93.26|
73910803|NCT02280304|147351907|SUPERIORITY||||||>|0.05||||||A priori threshold = voxel p\<.001, cluster p\<.05, FDR whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design. To report NS p-values and associated z-scores, uncorrected cluster ps were queried.|t-test, 1 sided|||Z-scores represent Fisher transformed correlation coefficients representing the correlations between hypothesized regions. Positive values represents positive connectivity between regions. Negative values represent anticorrelations, or negative relations, between hypothesized regions.||||>0.05
73910804|NCT02280304|147351908|OTHER||Mean Difference (Net)|1.8|||||TWO_SIDED|||||||||||||
73910805|NCT02280304|147351908|OTHER||Cohen's d|0.35|||||TWO_SIDED||||||||Cohen's d reflects Extent of Participation subscale of the CRIS, Post - Pre|||||
73910806|NCT02280304|147351908|OTHER||Median Difference (Net)|0.8|||||TWO_SIDED|||||||||||||
73910807|NCT02280304|147351908|OTHER||Cohen's d|0.14|||||TWO_SIDED||||||||Cohen's d reflects Extent of Participation Scale of the Cris pre- post|||||
73910808|NCT02280304|147351908|OTHER||Median Difference (Net)|0.8|||||TWO_SIDED|||||||||||||
73910809|NCT02280304|147351908|OTHER||Cohen's d|0.2|||||TWO_SIDED||||||||Cohens d reflects the Cris pre post Perceived Limitations scale|||||
73910810|NCT02280304|147351908|OTHER||Mean Difference (Net)|1.8|||||TWO_SIDED|||||||||||||
73910811|NCT02280304|147351908|OTHER||Cohens d|0.53|||||TWO_SIDED|||||||||||||
73910812|NCT02280304|147351908|OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|||||||||||||
73910813|NCT02280304|147351908|OTHER||Cohens d|0.29|||||TWO_SIDED|||||||||||||
74085359|NCT00243152|147724482|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the unaffected side.||||>0.05
74085360|NCT02625974|147724499|OTHER|A direct comparison|Difference in cure rate|14.0|||||TWO_SIDED|95.0|3.7|24.2||||||||24.2|3.7|
74085361|NCT02625974|147724500|OTHER|Incidence rate and 95% CI of seronegative conversion|Risk Ratio (RR)|2.12|||||TWO_SIDED|95.0|1.21|3.45|||||Person-year = 754|||3.45|1.21|
73910814|NCT02280304|147351908|OTHER||Mean Difference (Net)|0.6|||||TWO_SIDED|||||||||||||
73910815|NCT02280304|147351908|OTHER||Cohens d|0.13|||||TWO_SIDED|||||||||||||
73910816|NCT02280304|147351909|OTHER||Cohens d|0.86|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
73910817|NCT02280304|147351909|OTHER||Cohens d|0.3|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
74085362|NCT02625974|147724505|OTHER|Incidence rate and 95% CI of seronegative conversion|Risk Ratio (RR)|2.11|||||TWO_SIDED|95.0|0.91|4.16|||||Person-year = 379|||4.16|0.91|
74085363|NCT02875028|147724551|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
74085364|NCT01560819|147724590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Wilcoxon signed rank test|||A power calculation was not done for this pilot study. Changes in PUCAI post-treatment were compared with baseline using the Wilcoxon signed rank test. P value \<0.05 was considered statistically significant.||||0.03
74085365|NCT02344745|147724604|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
73910818|NCT02280304|147351910|OTHER||Cohens d|1.32|||||TWO_SIDED||||||||Cohen's d effect size change (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
73910819|NCT02280304|147351910|OTHER||Cohens d|0.27|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
73910820|NCT02280304|147351911|SUPERIORITY||||||<|0.0099||||||The p-value obtained for the L PHG seed/L IPL cluster is 0.0099. The critical p-value after Bonferroni correction for multiple seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p\<.001, cluster p\<.05 FDR corrected for multiple comparisons across the whole brain.||||||<.0099
73910821|NCT02280304|147351911|SUPERIORITY||||||<|0.02||||||The p-value obtained for the L anterior PGH seed/left VMPC cluster is 0.02. The critical p-value after Bonferroni correction for six seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p\<.001, cluster p\<.05 FDR corrected for multiple comparisons across the whole brain.||||||<0.02
73910822|NCT02280304|147351912|OTHER||Slope|0.02|||<|3.8e-05|TWO_SIDED|||||Cluster in MPFC p\<0.000038 FDR corrected for multiple comparisons across whole brain. Bonferroni correction for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).||||<.000038
73910823|NCT02280304|147351912|OTHER||Slope|0.02|||<|0.000149|TWO_SIDED|||||Cluster in the right cerebellum (crus 2) p\<0.000149 FDR corrected for multiple comparisons across the whole brain. Bonferroni for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).||||<0.000149
73910824|NCT01890473|147351942|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.908|||||TWO_SIDED|90.0|0.815|1.01||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale (using log (Cmax) without a formal test.||1.01|0.815|
73910825|NCT01890473|147351943|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.941|||||TWO_SIDED|90.0|0.843|1.05||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log (AUC (0-T) without a formal test.||1.05|0.843|
73910826|NCT01890473|147351944|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.976|||||TWO_SIDED|90.0|0.888|1.07||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log AUC(INF) without a formal test.||1.07|0.888|
73910827|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.07||||0.533|TWO_SIDED|90.0|-1.82|3.95|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on analysis of covariance (ANCOVA) using statistical analysis system (SAS) mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.95|-1.82|0.5330
73910828|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.9532|TWO_SIDED|90.0|-4.13|3.85|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.85|-4.13|0.9532
73910829|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.53||||0.2493|TWO_SIDED|90.0|-1.11|6.18|||ANCOVA|||Change at Day 14 12 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||6.18|-1.11|0.2493
73910830|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99||||0.2801|TWO_SIDED|90.0|-7.59|1.6|||ANCOVA|||Change at Day 14 2 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||1.60|-7.59|0.2801
73964992|NCT04714320|147465415|SUPERIORITY||||||=|0.053||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 92||||=0.053
73964993|NCT04714320|147465415|SUPERIORITY||||||=|0.893||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 106||||=0.893
73964994|NCT04714320|147465415|SUPERIORITY||||||=|0.662||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 106||||=0.662
73964995|NCT04714320|147465415|SUPERIORITY||||||=|0.688||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 120||||=0.688
74085366|NCT02344745|147724605|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
74085367|NCT02344745|147724606|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74085368|NCT02344745|147724607|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
74085369|NCT02788513|147724608|OTHER|||||||0.9931||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Beta model fit.|Model assumption: 75% of max effect is achieved at 2 mg, 87.5% at 5 mg, 25% at 25 mg, max effect achieved at 10 mg of BI 425809, scalar parameter = 26||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9931
73910831|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19||||0.9288|TWO_SIDED|90.0|-3.77|3.39|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.39|-3.77|0.9288
73910832|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.6459|TWO_SIDED|90.0|-2.62|4.58|||ANCOVA|||Change at Day 14 6 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.58|-2.62|0.6459
73910833|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.06||||0.0527|TWO_SIDED|90.0|0.63|7.48|||ANCOVA|||Change at Day 14 8 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||7.48|0.63|0.0527
73910834|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.29||||0.1998|TWO_SIDED|90.0|-0.95|7.52|||ANCOVA|||Change at Day 14 10 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||7.52|-0.95|0.1998
73964996|NCT04714320|147465415|SUPERIORITY||||||=|0.611||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 120||||=0.611
73964997|NCT04714320|147465415|SUPERIORITY||||||=|0.907||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 148||||=0.907
73964998|NCT04714320|147465415|SUPERIORITY||||||=|0.699||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 148||||=0.699
74026609|NCT02723630|147606685|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|96.51||||0.163|TWO_SIDED|90.0|92.53|100.65||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||100.65|92.53|0.1630
74026610|NCT02723630|147606686|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|99.68||||0.9427|TWO_SIDED|90.0|92.45|107.47||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||107.47|92.45|0.9427
74026611|NCT02723630|147606686|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|93.5||||0.0403|TWO_SIDED|90.0|88.63|98.64||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||98.64|88.63|0.0403
74026612|NCT02723630|147606687|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|100.29||||0.9373|TWO_SIDED|90.0|94.37|106.58||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.58|94.37|0.9373
73910835|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.6765|TWO_SIDED|90.0|-4.22|2.53|||ANCOVA|||Change at Day 15 12 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||2.53|-4.22|0.6765
73910836|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.6221|TWO_SIDED|90.0|-2.35|4.33|||ANCOVA|||Change at Day 15 4 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.33|-2.35|0.6221
73910837|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.81||||0.3|TWO_SIDED|90.0|-1.11|4.74|||ANCOVA|||Change at Day 15 6 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.74|-1.11|0.3000
73910838|NCT00934089|147351974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.9103|TWO_SIDED|90.0|-3.85|3.37|||ANCOVA|||Change at Day 15 8 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.37|-3.85|0.9103
73964999|NCT04714320|147465415|SUPERIORITY||||||=|0.802||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 169||||=0.802
73965000|NCT04714320|147465415|SUPERIORITY||||||=|0.206||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 169||||=0.206
74026613|NCT02723630|147606687|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|95.17||||0.0682|TWO_SIDED|90.0|91.03|99.5||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||99.50|91.03|0.0682
73910839|NCT00934089|147351976|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|59.2|||<|0.001|TWO_SIDED|95.0|38.69|79.7|||Fisher Exact|||Photophobia: p-value was calculated using fisher exact test.||79.70|38.69|<0.001
74026614|NCT02723630|147606688|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|98.73||||0.8448|TWO_SIDED|90.0|88.57|110.06||P value for formulation|Mixed Models Analysis||Geometric Least Squares Mean Ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||110.06|88.57|0.8448
74026615|NCT02723630|147606688|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|90.64||||0.0498|TWO_SIDED|90.0|83.51|98.38||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||98.38|83.51|0.0498
74026616|NCT01184989|147606700|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability analysis|Ratio|102.16|STANDARD_DEVIATION|22.8||||90.0|97.64|106.893|||Geometric Mean||Dispersion value is actually the intraindividual gCV.|Estimated local measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 136 quantifiable measurements.||106.893|97.640|
74026617|NCT01184989|147606701|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability analysis|Ratio|92.37|STANDARD_DEVIATION|23.5||||90.0|90.079|94.719|||Geometric Mean||The Dispersion Value is actually the intraindividual gCV.|Estimated central measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 468 quantifiable measurements.||94.719|90.079|
74026618|NCT01570491|147606703|SUPERIORITY_OR_OTHER|||||||0.83|||||||Kruskal-Wallis|||"We hypothesized that real-time US guidance would result in a 20% lower number of attempts compared to the control group.~At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group, therefore we planned to recruit 40 patients in total."||||0.83
73910840|NCT00934089|147351976|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.56||||0.612|TWO_SIDED|95.0|-14.8|7.68|||Fisher Exact|||Iritis: p-value was calculated using fisher exact test.||7.68|-14.80|0.612
73910841|NCT00934089|147351978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.42||||0.245|TWO_SIDED|90.0|-127.05|22.22|||ANCOVA|||Change at Day 13 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||22.22|-127.05|0.2450
73910842|NCT00934089|147351978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.51||||0.3068|TWO_SIDED|90.0|-21.89|90.91|||ANCOVA|||Change at Day 13 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||90.91|-21.89|0.3068
73910843|NCT00934089|147351978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.99||||0.2632|TWO_SIDED|90.0|-19.69|101.67|||ANCOVA|||Change at Day 35 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||101.67|-19.69|0.2632
73910844|NCT00934089|147351978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6||||0.8373|TWO_SIDED|90.0|-60.84|47.64|||ANCOVA|||Change at Day 35 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||47.64|-60.84|0.8373
73910845|NCT00494299|147352040|SUPERIORITY_OR_OTHER||Log Rank|0.2520462|||||||||||||The comparison between the 2 groups is done using the log rank test stratified by the response of TACE (Responder group A versus Responder group B), ECOG performance status (PS) (0 versus 1) and the number of prior TACE (1 versus 2).|||||
73910846|NCT00494299|147352040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8735||||||95.0|0.6972|1.0942|||||Hazard Ratio: Sorafenib/Placebo.|||1.0942|0.6972|
73910847|NCT03993132|147352052|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.91|1.11|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.11|0.91|
74026619|NCT01570491|147606704|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
74026620|NCT01570491|147606705|SUPERIORITY|||||||0.09|||||||Kruskal-Wallis|||||||0.09
74026621|NCT01570491|147606706|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||||||0.06
74026622|NCT01015443|147606722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.032||||0.921|TWO_SIDED|95.0|0.552|1.931|||Adjusted log rank|||||1.931|0.552|0.921
74026623|NCT05370157|147606728|SUPERIORITY||Mean Difference (Net)|4.25|STANDARD_ERROR_OF_MEAN|0.85||0.03|TWO_SIDED|95.0|0.76|7.74|||Regression, Linear|Satterthwaite Approximation||Intent-to-treat analyses tested changes in knowledge from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||7.74|0.76|.03
74085370|NCT02788513|147724608|OTHER|||||||0.9225||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Emax model fit.|Model assumption: 20% of the maximum effect is achieved at 2 mg||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9225
73910848|NCT03993132|147352053|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|1.01|1.13|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.13|1.01|
73910849|NCT03993132|147352054|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.84|1.08|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.08|0.84|
73910850|NCT03993132|147352055|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.96|1.11|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.11|0.96|
73910851|NCT03993132|147352056|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.61|0.83|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.83|0.61|
73965001|NCT04714320|147465416|SUPERIORITY||||||=|0.28||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 8||||=0.280
73965002|NCT04714320|147465416|SUPERIORITY||||||=|0.648||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 8||||=0.648
74026624|NCT05370157|147606729|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.3|TWO_SIDED|95.0|-0.4|0.2|||Regression, Linear|Satterthwaite Approximation||Intent-to-treat analyses tested changes in skill use from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.20|-0.40|.30
74085371|NCT02788513|147724608|OTHER|||||||0.9287||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Sigmoidal Emax model fit.|Model assumption: 25% of max effect achieved at 5 mg and 75% of max effect achieved at 10 mg of BI 425809.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9287
73910852|NCT03993132|147352057|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.76|0.91|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.91|0.76|
73910853|NCT03993132|147352058|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.88|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.88|
73910854|NCT03993132|147352059|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.91|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.91|
73910855|NCT03993132|147352060|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.88|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.88|
73965003|NCT04714320|147465416|SUPERIORITY||||||=|0.416||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 15||||=0.416
73965004|NCT04714320|147465416|SUPERIORITY||||||=|0.9||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 15||||=0.900
74085372|NCT02788513|147724608|OTHER|||||||0.7646||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod linear model fit.|No assumption needed.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.7646
74085373|NCT02788513|147724608|OTHER|||||||0.9335||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod linear in log model fit.|No assumption needed.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9335
73910856|NCT03993132|147352061|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.91|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.91|
73910857|NCT03993132|147352062|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.83|1.18|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.18|0.83|
73910858|NCT03993132|147352063|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.97|1.16|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.16|0.97|
73910859|NCT03993132|147352064|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.72|1.06|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.06|0.72|
73910860|NCT03993132|147352065|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.88|1.1|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.10|0.88|
73910861|NCT02805972|147352069|SUPERIORITY|"The null hypothesis is that there would be no difference across the Naloxone and placebo conditions.~The alternative hypothesis is that the cortisol value would be higher in the Naloxone condition than in the placebo condition."|Mean Difference (Final Values)|1.26||||0.067|TWO_SIDED|95.0|0.98|1.61||If the Winsorized value is excluded from analyses altogether, the P value is .012|t-test, 2 sided|Cortisol was log transformed for the statistical test, and the reported mean difference was exponentiated back to the original units of nmol/L below.||We compared cortisol values at 55 minutes, within person, across conditions. We Winsorized one participant's values for the placebo visit where values were between 2-4x above the 99th percentile value in the data and then log-transformed the data.||1.61|0.98|.067
73910862|NCT02635776|147352146|SUPERIORITY||Risk Difference (RD)|63.2|||<|0.0001|TWO_SIDED|95.0|53.0|73.3|||Farrington-Manning test|||Treatment difference at 600 mg||73.3|53|<0.0001
73910863|NCT02635776|147352147|SUPERIORITY||Risk Difference (RD)|47.8|||<|0.0001|TWO_SIDED|95.0|38.0|57.7|||Farrington-Manning test|||Treatment difference at 1000 mg||57.7|38|<0.0001
73910864|NCT02635776|147352148|SUPERIORITY||Risk Difference (RD)|68.5|||<|0.0001|TWO_SIDED|95.0|58.6|78.5|||Farrington-Manning test|||Treatment difference at 300 mg||78.5|58.6|<0.0001
73910865|NCT02635776|147352149|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (using equally spaced scores), stratified by region (North America, Europe)||Treatment difference in maximum severity||||<0.0001
73910866|NCT00788073|147352150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.05|||||||ANCOVA|||||||0.05
73910867|NCT00788073|147352151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.008||95.0|||||ANCOVA|||||||0.008
73910868|NCT02925117|147352156|SUPERIORITY||Least Squares (LS) Mean Difference|-51.4|STANDARD_ERROR_OF_MEAN|7.65|<|0.001|TWO_SIDED|95.0|-66.5|-36.3|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-36.3|-66.5|< 0.001
73910869|NCT02925117|147352156|SUPERIORITY||LS Mean Difference|-38.7|STANDARD_ERROR_OF_MEAN|7.61|<|0.001|TWO_SIDED|95.0|-53.7|-23.6|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-23.6|-53.7|<0.001
73910870|NCT02925117|147352156|SUPERIORITY||LS Mean Difference|-16.4|STANDARD_ERROR_OF_MEAN|7.61||0.032|TWO_SIDED|95.0|-31.4|-1.4|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-1.4|-31.4|0.032
73910871|NCT02925117|147352157|SUPERIORITY||Adjusted Difference|58.7|||<|0.001|TWO_SIDED|95.0|42.5|74.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||74.8|42.5|< 0.001
73910872|NCT02925117|147352157|SUPERIORITY||Adjusted Difference|42.5|||<|0.001|TWO_SIDED|95.0|25.5|59.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||59.6|25.5|<0.001
73910873|NCT02925117|147352157|SUPERIORITY||Adjusted Difference|18.7||||0.022|TWO_SIDED|95.0|2.7|34.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||34.7|2.7|0.022
73910874|NCT02925117|147352158|SUPERIORITY||Adjusted Difference|46.9|||<|0.001|TWO_SIDED|95.0|31.1|62.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||62.7|31.1|<0.001
73910875|NCT02925117|147352158|SUPERIORITY||Adjusted Difference|28.6|||<|0.001|TWO_SIDED|95.0|13.8|43.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||43.4|13.8|<0.001
73910876|NCT02925117|147352158|SUPERIORITY||Adjusted Difference|11.9||||0.044|TWO_SIDED|95.0|0.3|23.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||23.5|0.3|0.044
73910877|NCT02925117|147352159|SUPERIORITY||LS Mean Difference|-59.3|STANDARD_ERROR_OF_MEAN|6.58|<|0.001|TWO_SIDED|95.0|-72.3|-46.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-46.3|-72.3|<0.001
73910878|NCT02925117|147352159|SUPERIORITY||LS Mean Difference|-47.7|STANDARD_ERROR_OF_MEAN|6.78|<|0.001|TWO_SIDED|95.0|-61.1|-34.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-34.3|-61.1|<0.001
73910879|NCT02925117|147352159|SUPERIORITY||LS Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|6.7|<|0.001|TWO_SIDED|95.0|-44.3|-17.8|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-17.8|-44.3|<0.001
73910880|NCT02925117|147352159|SUPERIORITY||LS Mean Difference|-66.4|STANDARD_ERROR_OF_MEAN|8.85|<|0.001|TWO_SIDED|95.0|-83.9|-48.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-48.9|-83.9|<0.001
73910881|NCT02925117|147352159|SUPERIORITY||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|9.13|<|0.001|TWO_SIDED|95.0|-56.4|-20.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-20.4|-56.4|<0.001
73910882|NCT02925117|147352159|SUPERIORITY||LS Mean Difference|-28.9|STANDARD_ERROR_OF_MEAN|8.96||0.002|TWO_SIDED|95.0|-46.6|-11.2|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-11.2|-46.6|0.002
73910883|NCT02925117|147352159|SUPERIORITY||LS Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|9.78|<|0.001|TWO_SIDED|95.0|-78.6|-39.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-39.9|-78.6|<0.001
73910884|NCT02925117|147352159|SUPERIORITY||LS Mean Difference|-38.3|STANDARD_ERROR_OF_MEAN|10.08|<|0.001|TWO_SIDED|95.0|-58.3|-18.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-18.4|-58.3|<0.001
73910885|NCT02925117|147352159|SUPERIORITY||LS Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|9.9||0.003|TWO_SIDED|95.0|-49.4|-10.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-10.3|-49.4|0.003
73910886|NCT02925117|147352160|SUPERIORITY||LS Mean Difference|-65.3|STANDARD_ERROR_OF_MEAN|7.46|<|0.001|TWO_SIDED|95.0|-80.0|-50.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-50.5|-80.0|<0.001
73910887|NCT02925117|147352160|SUPERIORITY||LS Mean Difference|-47.9|STANDARD_ERROR_OF_MEAN|7.42|<|0.001|TWO_SIDED|95.0|-62.6|-33.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-33.3|-62.6|<0.001
73910888|NCT02925117|147352160|SUPERIORITY||LS Mean Difference|-26.2|STANDARD_ERROR_OF_MEAN|7.42|<|0.001|TWO_SIDED|95.0|-40.8|-11.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-11.5|-40.8|<0.001
73910889|NCT02925117|147352161|SUPERIORITY||LS Mean Difference|-58.3|STANDARD_ERROR_OF_MEAN|6.78|<|0.001|TWO_SIDED|95.0|-71.7|-44.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-44.9|-71.7|<0.001
73910890|NCT02925117|147352161|SUPERIORITY||LS Mean Difference|-37.1|STANDARD_ERROR_OF_MEAN|6.94|<|0.001|TWO_SIDED|95.0|-50.8|-23.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-23.4|-50.8|<0.001
73910891|NCT02925117|147352161|SUPERIORITY||LS Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|6.81|<|0.001|TWO_SIDED|95.0|-41.9|-15.0|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-15.0|-41.9|<0.001
73910892|NCT02925117|147352161|SUPERIORITY||LS Mean Difference|-48.0|STANDARD_ERROR_OF_MEAN|6.93|<|0.001|TWO_SIDED|95.0|-61.7|-34.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-34.3|-61.7|<0.001
73910893|NCT02925117|147352161|SUPERIORITY||LS Mean Difference|-34.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-48.5|-20.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-20.5|-48.5|<0.001
73910894|NCT02925117|147352161|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|6.96||0.004|TWO_SIDED|95.0|-33.9|-6.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-6.4|-33.9|0.004
73910895|NCT02925117|147352162|SUPERIORITY||Adjusted Difference|72.7|||<|0.001|TWO_SIDED|95.0|58.3|87.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||87.1|58.3|<0.001
73910896|NCT02925117|147352162|SUPERIORITY||Adjusted Difference|44.9|||<|0.001|TWO_SIDED|95.0|27.9|61.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||61.9|27.9|<0.001
73910897|NCT02925117|147352162|SUPERIORITY||Adjusted Difference|23.4||||0.004|TWO_SIDED|95.0|7.5|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||39.4|7.5|0.004
73910898|NCT02925117|147352163|SUPERIORITY||Adjusted Difference|70.7|||<|0.001|TWO_SIDED|95.0|56.2|85.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||85.2|56.2|<0.001
73965005|NCT04714320|147465416|SUPERIORITY||||||=|0.627||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 22||||=0.627
73965006|NCT04714320|147465416|SUPERIORITY||||||=|0.921||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 22||||=0.921
73965007|NCT04714320|147465416|SUPERIORITY||||||=|0.464||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 29||||=0.464
73965008|NCT04714320|147465416|SUPERIORITY||||||=|0.458||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 29||||=0.458
74085374|NCT02788513|147724608|OTHER|||||||0.8199||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod logistic model fit.|Model assumption: 10% of max effect achieved at 5 mg and 50% of max effect achieved at 10 mg of BI 425809.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.8199
73910899|NCT02925117|147352163|SUPERIORITY||Adjusted Difference|49.0|||<|0.001|TWO_SIDED|95.0|30.8|67.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||67.3|30.8|<0.001
74085375|NCT02788513|147724608|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.58||0.934|TWO_SIDED|95.0|-1.09|1.18||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.18|-1.09|0.9340
74085376|NCT02788513|147724608|OTHER||Median Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.6041|TWO_SIDED|95.0|-0.84|1.44||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.44|-0.84|0.6041
74085377|NCT02788513|147724608|OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.58||0.1926|TWO_SIDED|95.0|-0.38|1.9||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.90|-0.38|0.1926
74085378|NCT02788513|147724608|OTHER||Median Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.58||0.9739|TWO_SIDED|95.0|-1.16|1.12||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.12|-1.16|0.9739
74085379|NCT02788513|147724609|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.76||0.979|TWO_SIDED|95.0|-1.48|1.52||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||1.52|-1.48|0.979
73910900|NCT02925117|147352163|SUPERIORITY||Adjusted Difference|32.8|||<|0.001|TWO_SIDED|95.0|13.4|52.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||52.2|13.4|<0.001
73910901|NCT02925117|147352163|SUPERIORITY||Adjusted Difference|60.6|||<|0.001|TWO_SIDED|95.0|45.3|75.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||75.9|45.3|<0.001
73910902|NCT02925117|147352163|SUPERIORITY||Adjusted Difference|48.6|||<|0.001|TWO_SIDED|95.0|31.3|65.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||65.9|31.3|<0.001
73910903|NCT02925117|147352163|SUPERIORITY||Adjusted Difference|28.2||||0.003|TWO_SIDED|95.0|9.8|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||46.6|9.8|0.003
73910904|NCT02925117|147352164|SUPERIORITY||Adjusted Difference|43.8|||<|0.001|TWO_SIDED|95.0|29.1|58.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||58.5|29.1|<0.001
73910905|NCT02925117|147352164|SUPERIORITY||Adjusted Difference|26.1|||<|0.001|TWO_SIDED|95.0|12.6|39.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||39.6|12.6|<0.001
73910906|NCT02925117|147352164|SUPERIORITY||Adjusted Difference|9.4||||0.051|TWO_SIDED|95.0|0.0|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||18.8|-0.0|0.051
73910907|NCT02925117|147352164|SUPERIORITY||Adjusted Difference|46.9|||<|0.001|TWO_SIDED|95.0|31.3|62.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||62.4|31.3|<0.001
73910908|NCT02925117|147352164|SUPERIORITY||Adjusted Difference|23.8||||0.001|TWO_SIDED|95.0|9.6|38.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||38.1|9.6|0.001
73910909|NCT02925117|147352164|SUPERIORITY||Adjusted Difference|11.8||||0.049|TWO_SIDED|95.0|0.1|23.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||23.6|0.1|0.049
73910910|NCT02925117|147352165|SUPERIORITY||Adjusted Difference|68.4|||<|0.001|TWO_SIDED|95.0|54.0|82.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||82.8|54.0|<0.001
73910911|NCT02925117|147352165|SUPERIORITY||Adjusted Difference|35.3|||<|0.001|TWO_SIDED|95.0|18.5|52.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||52.2|18.5|<0.001
73910912|NCT02925117|147352165|SUPERIORITY||Adjusted Difference|25.7||||0.002|TWO_SIDED|95.0|9.6|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||41.7|9.6|0.002
74085380|NCT02788513|147724609|OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.77||0.521|TWO_SIDED|95.0|-1.01|2.0||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||2.00|-1.01|0.521
74085381|NCT02788513|147724609|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|0.77||0.047|TWO_SIDED|95.0|-3.04|-0.02||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||-0.02|-3.04|0.047
74085382|NCT02788513|147724609|OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.76||0.005|TWO_SIDED|95.0|-3.65|-0.67||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||-0.67|-3.65|0.005
74085383|NCT02788513|147724610|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.343|TWO_SIDED|95.0|-0.32|0.11||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.11|-0.32|0.343
73910913|NCT02925117|147352165|SUPERIORITY||Adjusted Difference|54.5|||<|0.001|TWO_SIDED|95.0|39.0|69.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||69.9|39.0|<0.001
73910914|NCT02925117|147352165|SUPERIORITY||Adjusted Difference|35.8|||<|0.001|TWO_SIDED|95.0|19.1|52.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||52.5|19.1|<0.001
73910915|NCT02925117|147352165|SUPERIORITY||Adjusted Difference|21.2||||0.008|TWO_SIDED|95.0|5.7|36.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||36.8|5.7|0.008
73910916|NCT02925117|147352166|SUPERIORITY||Adjusted Difference|30.4|||<|0.001|TWO_SIDED|95.0|16.2|44.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||44.6|16.2|<0.001
73910917|NCT02925117|147352166|SUPERIORITY||Adjusted Difference|9.4||||0.052|TWO_SIDED|95.0|-0.1|18.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||18.9|-0.1|0.052
73910918|NCT02925117|147352166|SUPERIORITY||Adjusted Difference|9.3||||0.048|TWO_SIDED|95.0|0.1|18.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||18.5|0.1|0.048
73910919|NCT02925117|147352166|SUPERIORITY||Adjusted Difference|37.7|||<|0.001|TWO_SIDED|95.0|22.2|53.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||53.3|22.2|<0.001
73910920|NCT02925117|147352166|SUPERIORITY||Adjusted Difference|19.0||||0.006|TWO_SIDED|95.0|5.6|32.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||32.5|5.6|0.006
73910921|NCT02925117|147352166|SUPERIORITY||Adjusted Difference|2.4||||0.581|TWO_SIDED|95.0|-6.0|10.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||10.8|-6.0|0.581
74026625|NCT05370157|147606733|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.45|TWO_SIDED|95.0|-1.25|0.79|||Regression, Linear|||Intent-to-treat analyses tested changes in psychological safety from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.79|-1.25|.45
73910922|NCT02925117|147352167|SUPERIORITY||Adjusted Difference|14.2||||0.012|TWO_SIDED|95.0|3.2|25.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||25.2|3.2|0.012
73910923|NCT02925117|147352167|SUPERIORITY||Adjusted Difference|2.3||||0.428|TWO_SIDED|95.0|-3.4|8.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||8.0|-3.4|0.428
73910924|NCT02925117|147352167|SUPERIORITY||Adjusted Difference|4.6||||0.206|TWO_SIDED|95.0|-2.5|11.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||11.8|-2.5|0.206
73910925|NCT02925117|147352167|SUPERIORITY||Adjusted Difference|23.3|||<|0.001|TWO_SIDED|95.0|10.4|36.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||36.2|10.4|<0.001
73910926|NCT02925117|147352167|SUPERIORITY||Adjusted Difference|9.4||||0.048|TWO_SIDED|95.0|0.1|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||18.8|0.1|0.048
73910927|NCT02925117|147352167|SUPERIORITY||Adjusted Difference|2.4||||0.426|TWO_SIDED|95.0|-3.4|8.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||8.1|-3.4|0.426
73910928|NCT02925117|147352173|SUPERIORITY||LS Mean Difference|-26.5|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-34.9|-18.1|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-18.1|-34.9|<0.001
73910929|NCT02925117|147352173|SUPERIORITY||LS Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|4.27|<|0.001|TWO_SIDED|95.0|-31.4|-14.6|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-14.6|-31.4|<0.001
73910930|NCT02925117|147352173|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|4.25||0.075|TWO_SIDED|95.0|-16.0|0.8|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||0.8|-16.0|0.075
73910931|NCT02925117|147352174|SUPERIORITY||Adjusted Difference|47.4|||<|0.001|TWO_SIDED|95.0|29.6|65.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||65.2|29.6|<0.001
73910932|NCT02925117|147352174|SUPERIORITY||Adjusted Difference|53.4|||<|0.001|TWO_SIDED|95.0|35.5|71.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||71.3|35.5|<0.001
73910933|NCT02925117|147352174|SUPERIORITY||Adjusted Difference|18.6||||0.021|TWO_SIDED|95.0|2.8|34.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||34.3|2.8|0.021
73910934|NCT00347360|147352191|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.41499. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.||||>0.1
73910935|NCT00347360|147352192|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.00485. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.||||>0.1
73910936|NCT02187744|147352218|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough \>20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.02|6.49|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||6.49|-8.02|
73910937|NCT02187744|147352218|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough \>20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|3.78|||TWO_SIDED|95.0|-8.59|6.23|||||Unstratified analysis.|||6.23|-8.59|
73910938|NCT02187744|147352220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81|STANDARD_ERROR_OF_MEAN|7.03|||TWO_SIDED|95.0|-16.58|10.96|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||10.96|-16.58|
73910939|NCT02187744|147352220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|7.35|||TWO_SIDED|95.0|-17.4|11.4|||||Unstratified analysis.|||11.40|-17.40|
73910940|NCT02187744|147352221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|5.09|||TWO_SIDED|95.0|-4.01|15.94|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||15.94|-4.01|
73910941|NCT02187744|147352221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|95.0|-4.08|16.27|||||Unstratified analysis.|||16.27|-4.08|
73910942|NCT01972568|147352224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.1208|TWO_SIDED|95.0|0.89|2.72|||Logistic regression model|||||2.72|0.89|0.1208
73910943|NCT01972568|147352232|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.31||||0.0048|TWO_SIDED|95.0|1.44|7.61|||Logistic regression model|||||7.61|1.44|0.0048
73910944|NCT01972568|147352233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.0202|TWO_SIDED|95.0|1.11|3.46|||Logistic regression model|||||3.46|1.11|0.0202
73910945|NCT00306189|147352245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|5.76|8.24|||t-test, 2 sided|||||8.24|5.76|<0.0001
73910946|NCT00306189|147352245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.25|||<|0.0001||95.0|4.1|6.4|||t-test, 2 sided|||||6.4|4.1|<0.0001
73910947|NCT00306189|147352245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.27|||<|0.0001||95.0|5.06|7.49|||t-test, 2 sided|||||7.49|5.06|<0.0001
73910948|NCT02572401|147352246|SUPERIORITY||Risk Ratio (RR)|0.84|||<|0.05|TWO_SIDED|95.0|0.59|1.21|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.21|.59|<.05
73910949|NCT02572401|147352246|SUPERIORITY||Risk Ratio (RR)|0.99|||<|0.05|TWO_SIDED|95.0|0.69|1.42|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.42|0.69|<.05
73910950|NCT02572401|147352246|SUPERIORITY||Risk Ratio (RR)|0.72|||<|0.05|TWO_SIDED|95.0|0.35|1.49|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.49|.35|<.05
73910951|NCT02572401|147352247|SUPERIORITY||Risk Ratio (RR)|1.04|||<|0.05|TWO_SIDED|95.0|0.92|1.18|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.18|0.92|<.05
73910952|NCT02572401|147352247|SUPERIORITY||Risk Ratio (RR)|1.02|||<|0.05|TWO_SIDED|95.0|0.9|1.16|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.16|0.90|<.05
73910953|NCT02572401|147352247|SUPERIORITY||Risk Ratio (RR)|1.1|||<|0.05|TWO_SIDED|95.0|0.86|1.42|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.42|0.86|<.05
73910954|NCT02572401|147352248|SUPERIORITY||Risk Ratio (RR)|1.05|||<|0.05|TWO_SIDED|95.0|0.89|1.24|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.24|0.89|<.05
73965009|NCT04714320|147465416|SUPERIORITY||||||=|0.779||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 36||||=0.779
73910955|NCT02572401|147352248|SUPERIORITY||Risk Ratio (RR)|1.1|||<|0.05|TWO_SIDED|95.0|0.94|1.3|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.|The numerator is the treatment.|1.30|0.94|<.05
73910956|NCT02572401|147352248|SUPERIORITY||Risk Ratio (RR)|1.05|||<|0.05|TWO_SIDED|95.0|0.76|1.47|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.47|0.76|<.05
73910957|NCT02572401|147352249|SUPERIORITY||Risk Ratio (RR)|1.04|||<|0.05|TWO_SIDED|95.0|0.73|1.48|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.48|0.73|<.05
73910958|NCT02572401|147352249|SUPERIORITY||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED|95.0|0.71|1.45|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.45|0.71|<.05
74026626|NCT05370157|147606734|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.89|TWO_SIDED|95.0|-0.44|0.4|||Regression, Linear|||Intent-to-treat analyses tested changes in learning behavior from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.40|-0.44|.89
73910959|NCT02572401|147352249|SUPERIORITY||Risk Ratio (RR)|1.02|||<|0.05|TWO_SIDED|95.0|0.5|2.08|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||2.08|.50|<.05
73910960|NCT02572401|147352250|SUPERIORITY||Mean Difference (Final Values)|0.001|||<|0.05|TWO_SIDED|95.0|-0.078|0.08|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||0.080|-0.078|<.05
73910961|NCT02572401|147352250|SUPERIORITY||Mean Difference (Final Values)|-0.003|||<|0.05|TWO_SIDED|95.0|-0.082|0.076|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||0.076|-0.082|<.05
73910962|NCT02572401|147352250|SUPERIORITY||Mean Difference (Final Values)|-0.009|||<|0.05|TWO_SIDED|95.0|-0.167|0.149|||Regression, Linear|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.||The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||0.149|-0.167|<.05
73910963|NCT01090492|147352273|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11||||0.6513|TWO_SIDED|80.0|-0.21|0.44|||ANCOVA|||PRP: Adjusted mean difference analysis was based on Analysis of Covariance (ANCOVA) model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.44|-0.21|0.6513
73910964|NCT01090492|147352273|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.69||||0.0057|TWO_SIDED|80.0|-0.99|-0.38|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.38|-0.99|0.0057
73910965|NCT01090492|147352273|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44||||0.1157|TWO_SIDED|80.0|-0.8|-0.08|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.08|-0.80|0.1157
73910966|NCT01090492|147352273|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15||||0.6286|TWO_SIDED|80.0|-0.56|0.25|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.25|-0.56|0.6286
73910967|NCT01090492|147352274|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12||||0.9504|TWO_SIDED|80.0|-2.43|2.68|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||2.68|-2.43|0.9504
74085384|NCT02788513|147724610|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.645|TWO_SIDED|95.0|-0.26|0.16||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.16|-0.26|0.645
74085385|NCT02788513|147724610|OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.11||0.448|TWO_SIDED|95.0|-0.13|0.3||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.30|-0.13|0.448
74085386|NCT02788513|147724610|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED|95.0|-0.11|0.32||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.32|-0.11|0.340
73910968|NCT01090492|147352274|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.35||||0.4651|TWO_SIDED|80.0|-3.74|1.03|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.03|-3.74|0.4651
73910969|NCT01090492|147352274|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.59||||0.7423|TWO_SIDED|80.0|-2.92|1.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.73|-2.92|0.7423
73910970|NCT01090492|147352274|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.91||||0.3524|TWO_SIDED|80.0|-4.55|0.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.73|-4.55|0.3524
73910971|NCT01090492|147352275|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.21||||0.79|TWO_SIDED|80.0|-4.61|7.03|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||7.03|-4.61|0.7900
73910972|NCT01090492|147352275|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.17||||0.1463|TWO_SIDED|80.0|-11.61|-0.73|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.73|-11.61|0.1463
73910973|NCT01090492|147352275|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.37||||0.1446|TWO_SIDED|80.0|-4.44|-0.29|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.29|-4.44|0.1446
73910974|NCT01090492|147352275|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.09||||0.5497|TWO_SIDED|80.0|-3.45|1.26|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.26|-3.45|0.5497
73910975|NCT01090492|147352276|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.15||||0.5909|TWO_SIDED|80.0|-0.21|0.52|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.52|-0.21|0.5909
73910976|NCT01090492|147352276|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.77||||0.0053|TWO_SIDED|80.0|-1.12|-0.43|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.43|-1.12|0.0053
73910977|NCT01090492|147352276|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28||||0.3462|TWO_SIDED|80.0|-0.67|0.1|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.10|-0.67|0.3462
73910978|NCT01090492|147352276|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44||||0.194|TWO_SIDED|80.0|-0.88|-0.01|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.01|-0.88|0.1940
73910979|NCT00945893|147352282|NON_INFERIORITY_OR_EQUIVALENCE|The currently proposed study provided at least 99.9% power to rule out a rate increase of 10 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 3%. Power is also high if the true difference is slightly greater than zero and the true fever rate is ≤ 3%.|Rate difference|0.0|||||TWO_SIDED|95.0|-6.0|1.9|||Score|||The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): Rate Difference ≥ 10%, HA (alternative): Rate Difference \< 10%||1.9|-6.0|
73910980|NCT00945893|147352283|SUPERIORITY_OR_OTHER||rate difference|2.5|||||TWO_SIDED|95.0|-8.8|7.7|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||7.7|-8.8|
73910981|NCT00945893|147352284|SUPERIORITY_OR_OTHER||rate difference|6.1|||||TWO_SIDED|95.0|-5.6|12.6|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact CIs for the rate difference (Vaccine minus Placebo).||12.6|-5.6|
73910982|NCT00945893|147352285|SUPERIORITY_OR_OTHER||rate difference|9.3|||||TWO_SIDED|95.0|-0.8|16.3|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||16.3|-0.8|
73910983|NCT00945893|147352286|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|10.0|||||TWO_SIDED|95.0|-4.1|22.8|||Score|||||22.8|-4.1|
74085387|NCT00951093|147724666|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P value adjusted for multiple comparisons|Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||<0.001
74085388|NCT00951093|147724667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||0.002
74085389|NCT00951093|147724668|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Friedman´s test|||||||< 0.001
73910984|NCT00945893|147352289|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|0.4|||||TWO_SIDED|95.0|-13.9|14.5|||Score|||||14.5|-13.9|
73910985|NCT00945893|147352292|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|-0.5|||||TWO_SIDED|95.0|-14.7|11.8|||Score|||||11.8|-14.7|
73910986|NCT00945893|147352295|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|2.0|||||TWO_SIDED|95.0|-12.6|14.9|||Score|||||14.9|-12.6|
73910987|NCT00945893|147352304|SUPERIORITY_OR_OTHER||rate difference|5.8|||||TWO_SIDED|95.0|-7.7|13.8|||score|||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||13.8|-7.7|
73910988|NCT00945893|147352305|SUPERIORITY_OR_OTHER||rate difference|-6.0|||||TWO_SIDED|95.0|-23.5|5.3|||score|||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||5.3|-23.5|
73910989|NCT00945893|147352306|SUPERIORITY_OR_OTHER||rate difference|2.4|||||TWO_SIDED|95.0|-9.3|10.8|||score|||The number of participants who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||10.8|-9.3|
73910990|NCT00144391|147352342|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
73910991|NCT01332500|147352361|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan tablets|paired t-test 2-sided|||||||<0.001
73910992|NCT01332500|147352361|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided|||||||<0.001
73910993|NCT01332500|147352361|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Opioid tablets|paired t-test 2-sided|||||||0.005
73910994|NCT01332500|147352361|SUPERIORITY_OR_OTHER|||||||0.336||95.0||||Ergot tablets|paired t-test 2-sided|||||||0.336
73910995|NCT01332500|147352361|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||Other tablets|paired t-test 2-sided|||||||0.162
73910996|NCT01332500|147352362|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plan costs|paired t-test 2-sided|||||||<0.001
73910997|NCT01332500|147352362|SUPERIORITY_OR_OTHER|||||||0.349||95.0||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided|||||||0.349
73910998|NCT01332500|147352362|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||Opioid health plan costs|paired t-test 2-sided|||||||0.208
73910999|NCT01332500|147352362|SUPERIORITY_OR_OTHER|||||||0.239||95.0||||Ergot health plan costs|paired t-test 2-sided|||||||0.239
73911000|NCT01332500|147352362|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||Other health plan costs|paired t-test 2-sided|||||||0.583
73911001|NCT01332500|147352362|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total heath plan costs|paired t-test 2-sided|||||||<0.001
73911002|NCT01332500|147352363|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plus copay costs|paired t-test 2-sided|||||||<0.001
73911003|NCT01332500|147352363|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||Non-steroidal, anti-inflammatory drug health plus copay costs|paired t-test 2-sided|||||||0.177
73911004|NCT01332500|147352363|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||Opioid health plus copay costs|paired t-test 2-sided|||||||0.173
73911005|NCT01332500|147352363|SUPERIORITY_OR_OTHER|||||||0.191||95.0||||Ergot health plus copay costs|paired t-test 2-sided|||||||0.191
73911006|NCT01332500|147352363|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Other health plus copay costs|paired t-test 2-sided|||||||0.254
73911007|NCT01332500|147352363|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total health plus copay costs|paired t-test 2-sided|||||||<0.001
73911008|NCT01332500|147352364|SUPERIORITY_OR_OTHER|||||||0.866||95.0||||Triptan tablets|paired t-test 2-sided|||||||0.866
73911009|NCT01332500|147352364|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided|||||||0.094
73911010|NCT01332500|147352364|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||Opioid tablets|paired t-test 2-sided|||||||0.832
73911011|NCT01332500|147352364|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||Ergot tablets|paired t-test 2-sided|||||||0.392
73911012|NCT01332500|147352364|SUPERIORITY_OR_OTHER|||||||0.752||95.0||||Other tablets|paired t-test 2-sided|||||||0.752
73911013|NCT01332500|147352365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plan costs|paired t-test 2-sided|||||||<0.001
73911014|NCT01332500|147352365|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided|||||||0.054
73911015|NCT01332500|147352365|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Opioid health plan costs|paired t-test 2-sided|||||||0.590
73911016|NCT01332500|147352365|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Ergot health plan costs|paired t-test 2-sided|||||||0.382
73911017|NCT01332500|147352365|SUPERIORITY_OR_OTHER|||||||0.343||95.0||||Other health plan costs|paired t-test 2-sided|||||||0.343
73911018|NCT01332500|147352365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total health plan costs|paired t-test 2-sided|||||||<0.001
73911019|NCT01332500|147352366|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plus copay costs|paired t-test 2-sided|||||||<0.001
73911020|NCT01332500|147352366|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Non-steroidal anti-inflammatory drug health plus copay costs|paired t-test 2-sided|||||||0.146
73911021|NCT01332500|147352366|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||Opioid health plus copay costs|paired t-test 2-sided|||||||0.826
73911022|NCT01332500|147352366|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||Ergot health plus copay costs|paired t-test 2-sided|||||||0.354
74085390|NCT00951093|147724669|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.02||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||< 0.020
74085391|NCT00951093|147724670|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||< 0.001
73911023|NCT01332500|147352366|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||Other health plus copay costs|paired t-test 2-sided|||||||0.514
73911024|NCT01332500|147352366|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Total health plus copay costs|paired t-test 2-sided|||||||0.001
73911025|NCT01034631|147352370|OTHER|||||||0.6625|||||||Chi-squared|||||||.6625
73911026|NCT01292746|147352378|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|2 sided t-test for correlated samples.||||||<0.05
73911027|NCT00680017|147352387|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 primary efficacy endpoint comparison."|Wilcoxon rank-sum test|||The null hypothesis was that percent change in triglycerides (TG) from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in TG from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 98% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in TG.||||<0.001
73911028|NCT00680017|147352388|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 secondary endpoint comparison."|ANCOVA|P-value obtained from an ANCOVA with corresponding baseline value as the covariate and an effect for treatment group.||The null hypothesis was that percent change in HDL-C from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in HDL-C from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 82% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in HDL-C.||||<0.001
73911029|NCT01773733|147352459|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73911030|NCT00705289|147352460|SUPERIORITY_OR_OTHER||Pearson Product Moment Correlation|0.1402||||0.0003|||||||Test for non-zero correlation|||Relationship between baseline DAS28 and age (prior to infliximab therapy)||||0.0003
73911031|NCT00705289|147352461|SUPERIORITY_OR_OTHER||Pearson Product Moment Correlation|-0.01||||0.7991||95.0|||||Test for non-zero correlation|||Relationship between baseline DAS28 and time since diagnosis (prior to infliximab therapy)||||0.7991
73911032|NCT00705289|147352462|SUPERIORITY_OR_OTHER|||||||0.7152||95.0|||||ANOVA|The association between Baseline DAS28 and gender is based on a one-way Anova.||Relationship between baseline DAS28 and gender (prior to infliximab therapy)||||0.7152
73911033|NCT00705289|147352463|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Relationship between DAS28 and Country of Residence was based on a 1-way ANOVA calculated as P-value.||Relationship between baseline DAS28 and country of residence (prior to infliximab therapy)||||<0.0001
73911034|NCT00705289|147352464|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.2|STANDARD_DEVIATION|1.15||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (all subjects, prior to infliximab therapy)||5.3|5.1|
73911035|NCT00705289|147352464|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.3|STANDARD_DEVIATION|1.16||||95.0|5.0|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with early RA, not treated with anti-TNF; prior to infliximab therapy)||5.5|5.0|
73911036|NCT00705289|147352464|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.2|STANDARD_DEVIATION|1.14||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA not treated with anti-TNF; prior to infliximab therapy)||5.3|5.1|
74085392|NCT00951093|147724671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||0.001
74085393|NCT00951093|147724672|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||< 0.001
73911037|NCT00705289|147352464|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.3|STANDARD_DEVIATION|1.16||||95.0|5.1|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA who failed or did not tolerate another anti-TNF; prior to infliximab therapy)||5.5|5.1|
73911038|NCT02609828|147352471|SUPERIORITY||Differences in least square (LS) mean|-0.78|STANDARD_ERROR_OF_MEAN|0.37||0.0381|TWO_SIDED|95.0|-1.52|-0.04|||ANCOVA|||Change at Week 8: Analysis of covariance (ANCOVA) model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.04|-1.52|0.0381
73965010|NCT04714320|147465416|SUPERIORITY||||||=|0.629||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 36||||=0.629
74085394|NCT01933919|147724678|SUPERIORITY||LS Mean Difference (Fluvoxamine-Placebo)|-4.3|STANDARD_ERROR_OF_MEAN|2.07||0.044|TWO_SIDED|95.0|-8.5|-0.1|||ANCOVA|ANCOVA with baseline JCY-BOCS (10-item) total score and age as covariates and treatment as fixed effect.|The model included the fixed effects of treatment, with baseline JCY-BOCS (10-item) total score and age as covariates.|||-0.1|-8.5|0.044
74085395|NCT03449199|147724761|SUPERIORITY||LS Mean Difference|-0.05||||0.7953|TWO_SIDED|95.0|-0.44|0.34|||ANCOVA|||Change from baseline in log-transformed UACR was analyzed using an ANCOVA model with randomized treatment, and randomization strata of sUA and UACR as independent variables. The last observation carried forward imputation was used for missing data. In this study, multiplicity was not considered since the study objective is exploratory.||0.34|-0.44|0.7953
74085396|NCT03449199|147724761|SUPERIORITY||LS Mean Difference|-0.43||||0.0311|TWO_SIDED|95.0|-0.82|-0.04|||ANCOVA|||Change from baseline in log-transformed UACR was analyzed using an ANCOVA model with randomized treatment, and randomization strata of sUA and UACR as independent variables. The last observation carried forward imputation was used for missing data. In this study, multiplicity was not considered since the study objective is exploratory.||-0.04|-0.82|0.0311
74085397|NCT03449199|147724762|SUPERIORITY||LS Mean Difference|1.71||||0.4055|TWO_SIDED|95.0|-2.35|5.78|||ANCOVA|||For Week 12 (visit of the primary outcome), ANCOVA model with treatment, randomization strata of sUA and UACR levels as independent variables, Baseline eGFR as covariate is fitted. The last observation carried forward imputation was used for missing data.||5.78|-2.35|0.4055
74085398|NCT03449199|147724762|SUPERIORITY||LS Mean Difference|3.42||||0.096|TWO_SIDED|95.0|-0.62|7.46|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of sUA and UACR levels as independent variables, Baseline eGFR as covariate is fitted. The last observation carried forward imputation was used for missing data.||7.46|-0.62|0.0960
74085399|NCT03449199|147724763|SUPERIORITY||LS Mean Difference|-2.43|||<|0.0001|TWO_SIDED|95.0|-3.13|-1.74|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||-1.74|-3.13|<0.0001
74085400|NCT03449199|147724763|SUPERIORITY||LS Mean Difference|-3.23|||<|0.0001|TWO_SIDED|95.0|-3.91|-2.54|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||-2.54|-3.91|<0.0001
74085401|NCT03449199|147724764|SUPERIORITY||LS Mean Difference|-102.02||||0.3955|TWO_SIDED|95.0|-338.81|134.78|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||134.78|-338.81|0.3955
73911039|NCT02609828|147352472|SUPERIORITY||Difference in LS mean|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0497|TWO_SIDED|95.0|-0.72|0.0|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.00|-0.72|0.0497
73911040|NCT02609828|147352472|SUPERIORITY||Difference in LS mean|-0.66|STANDARD_ERROR_OF_MEAN|0.25||0.0092|TWO_SIDED|95.0|-1.16|-0.17|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.16|0.0092
73911041|NCT02609828|147352472|SUPERIORITY||Difference in LS mean|-0.74|STANDARD_ERROR_OF_MEAN|0.32||0.0218|TWO_SIDED|95.0|-1.37|-0.11|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.11|-1.37|0.0218
73911042|NCT02609828|147352472|SUPERIORITY||Difference in LS mean|-0.87|STANDARD_ERROR_OF_MEAN|0.36||0.0154|TWO_SIDED|95.0|-1.58|-0.17|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.58|0.0154
73911043|NCT02609828|147352472|SUPERIORITY||Difference in LS mean|-0.59|STANDARD_ERROR_OF_MEAN|0.39||0.1289|TWO_SIDED|95.0|-1.36|0.17|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.17|-1.36|0.1289
73911044|NCT02609828|147352472|SUPERIORITY||Difference in LS mean|-0.55|STANDARD_ERROR_OF_MEAN|0.44||0.211|TWO_SIDED|95.0|-1.43|0.32|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.32|-1.43|0.2110
74085402|NCT03449199|147724764|SUPERIORITY||LS Mean Difference|-197.49||||0.0991|TWO_SIDED|95.0|-432.73|37.75|||ANCOVA|||For Week 12 (visit of the primary outcome), ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||37.75|-432.73|0.0991
74085403|NCT03449199|147724765|SUPERIORITY||Odds Ratio (OR)|1.72||||0.2791|TWO_SIDED||||||Regression, Logistic||Missing observations at Study Week 12 are imputed as nonresponse.|Odds ratio, 95% CLs, and p-values are obtained from logistic regression model adjusting for treatment group, randomization strata of Baseline sUA (\<6.0 vs ≥6.0 mg/dL) and Baseline UACR (200 to \<300 mg/g vs 300 to ≤3000 mg/g), Baseline UACR and Baseline sUA levels. Odds ratio for a baseline covariate is the ratio of odds over one unit increase of the covariate and it is assumed constant. P-value represents the statistical significance level of odds ratio differing from 1.||||0.2791
74085404|NCT03449199|147724765|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0507|TWO_SIDED||||||Regression, Logistic|||Odds ratio, 95% CLs, and p-values are obtained from logistic regression model adjusting for treatment group, randomization strata of Baseline sUA (\<6.0 vs ≥6.0 mg/dL) and Baseline UACR (200 to \<300 mg/g vs 300 to ≤3000 mg/g), Baseline UACR and Baseline sUA levels. Odds ratio for a baseline covariate is the ratio of odds over one unit increase of the covariate and it is assumed constant. P-value represents the statistical significance level of odds ratio differing from 1.||||0.0507
73911045|NCT02609828|147352472|SUPERIORITY||Difference in LS mean|-0.58|STANDARD_ERROR_OF_MEAN|0.46||0.2049|TWO_SIDED|95.0|-1.49|0.32|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.32|-1.49|0.2049
73911046|NCT02609828|147352473|SUPERIORITY||Difference in LS mean|-0.33|STANDARD_ERROR_OF_MEAN|0.2||0.1103|TWO_SIDED|95.0|-0.73|0.07|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.07|-0.73|0.1103
73911047|NCT02609828|147352473|SUPERIORITY||Difference in LS mean|-0.73|STANDARD_ERROR_OF_MEAN|0.27||0.0084|TWO_SIDED|95.0|-1.26|-0.19|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.19|-1.26|0.0084
73911048|NCT02609828|147352473|SUPERIORITY||Difference in LS mean|-0.75|STANDARD_ERROR_OF_MEAN|0.33||0.0236|TWO_SIDED|95.0|-1.39|-0.1|||ANCOVA|||Change at Week 4:ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.10|-1.39|0.0236
73911049|NCT02609828|147352473|SUPERIORITY||Difference in LS mean|-0.88|STANDARD_ERROR_OF_MEAN|0.36||0.0155|TWO_SIDED|95.0|-1.59|-0.17|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.59|0.0155
73911050|NCT02609828|147352473|SUPERIORITY||Difference in LS mean|-0.76|STANDARD_ERROR_OF_MEAN|0.38||0.0505|TWO_SIDED|95.0|-1.52|0.0|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.00|-1.52|0.0505
73911051|NCT02609828|147352473|SUPERIORITY||Difference in LS mean|-0.72|STANDARD_ERROR_OF_MEAN|0.4||0.0761|TWO_SIDED|95.0|-1.52|0.08|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.08|-1.52|0.0761
73911052|NCT02609828|147352473|SUPERIORITY||Difference in LS mean|-0.74|STANDARD_ERROR_OF_MEAN|0.48||0.1263|TWO_SIDED|95.0|-1.7|0.21|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.21|-1.70|0.1263
73911053|NCT02609828|147352473|SUPERIORITY||Difference in LS mean|-0.79|STANDARD_ERROR_OF_MEAN|0.49||0.1051|TWO_SIDED|95.0|-1.76|0.17|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.17|-1.76|0.1051
73911054|NCT02609828|147352474|SUPERIORITY||Difference in LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.3003|TWO_SIDED|95.0|-1.47|0.47|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.47|-1.47|0.3003
73911055|NCT02609828|147352474|SUPERIORITY||Difference in LS mean|-0.84|STANDARD_ERROR_OF_MEAN|0.59||0.1603|TWO_SIDED|95.0|-2.03|0.35|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.35|-2.03|0.1603
73911056|NCT02609828|147352474|SUPERIORITY||Difference in LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.2298|TWO_SIDED|95.0|-2.13|0.53|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.53|-2.13|0.2298
73911057|NCT02609828|147352474|SUPERIORITY||Difference in LS mean|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5054|TWO_SIDED|95.0|-1.93|0.97|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.97|-1.93|0.5054
73911058|NCT02609828|147352474|SUPERIORITY||Difference in LS mean|-0.55|STANDARD_ERROR_OF_MEAN|-0.77||0.4793|TWO_SIDED|95.0|-2.1|1.01|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||1.01|-2.10|0.4793
74026627|NCT05370157|147606735|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.36||0.85|TWO_SIDED|95.0|-1.51|1.36|||Regression, Linear|||Intent-to-treat analyses tested changes in team performance from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||1.36|-1.51|.85
74026628|NCT01144637|147606761|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 2)|1.1012|||||TWO_SIDED|95.0|0.9992|1.2136||||||||1.2136|0.9992|
74026629|NCT01144637|147606761|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 3)|0.9444|||||TWO_SIDED|95.0|0.8554|1.0427||||||||1.0427|0.8554|
73911059|NCT02609828|147352474|SUPERIORITY||Difference in LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.66||0.4496|TWO_SIDED|95.0|-1.83|0.83|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.83|-1.83|0.4496
73911060|NCT02609828|147352474|SUPERIORITY||Difference in least square LS mean|-1.21|STANDARD_ERROR_OF_MEAN|0.77||0.1263|TWO_SIDED|95.0|-2.77|0.36|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.36|-2.77|0.1263
73911061|NCT02609828|147352474|SUPERIORITY||Difference in LS mean|-1.05|STANDARD_ERROR_OF_MEAN|0.73||0.162|TWO_SIDED|95.0|-2.54|0.44|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.44|-2.54|0.1620
73911062|NCT02609828|147352475|SUPERIORITY||Difference in LS mean|-1.07|STANDARD_ERROR_OF_MEAN|0.54||0.0575|TWO_SIDED|95.0|-2.17|0.04|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.04|-2.17|0.0575
73911063|NCT02609828|147352475|SUPERIORITY||Difference in LS mean|-1.96|STANDARD_ERROR_OF_MEAN|0.62||0.0031|TWO_SIDED|95.0|-3.22|-0.7|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.70|-3.22|0.0031
73911064|NCT02609828|147352475|SUPERIORITY||Difference in LS mean|-1.44|STANDARD_ERROR_OF_MEAN|0.68||0.041|TWO_SIDED|95.0|-2.82|-0.06|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.06|-2.82|0.0410
73911065|NCT02609828|147352475|SUPERIORITY||Difference in LS mean|-0.88|STANDARD_ERROR_OF_MEAN|0.77||0.2598|TWO_SIDED|95.0|-2.44|0.68|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.68|-2.44|0.2598
73911066|NCT02609828|147352475|SUPERIORITY||Difference in LS mean|-0.77|STANDARD_ERROR_OF_MEAN|0.8||0.3426|TWO_SIDED|95.0|-2.38|0.85|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.85|-2.38|0.3426
73911067|NCT02609828|147352475|SUPERIORITY||Difference in LS mean|-1.2|STANDARD_ERROR_OF_MEAN|0.72||0.1034|TWO_SIDED|95.0|-2.65|0.26|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.26|-2.65|0.1034
73965011|NCT04714320|147465416|SUPERIORITY||||||=|0.242||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 43||||=0.242
74026630|NCT01144637|147606761|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 2 / Group 3)|0.8577|||||TWO_SIDED|95.0|0.7753|0.9488||||||||0.9488|0.7753|
73911068|NCT02609828|147352475|SUPERIORITY||Difference in LS mean|-1.91|STANDARD_ERROR_OF_MEAN|0.84||0.029|TWO_SIDED|95.0|-3.6|-0.21|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.21|-3.60|0.0290
73911069|NCT02609828|147352475|SUPERIORITY||Difference in LS mean|-1.62|STANDARD_ERROR_OF_MEAN|0.83||0.06|TWO_SIDED|95.0|-3.31|0.07|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.07|-3.31|0.0600
74085405|NCT02618382|147724776|SUPERIORITY||||||<|0.05||||||The P values for differences among time point means were determined by ANOVA for continuous variables|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
73911070|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8054|TWO_SIDED|95.0|0.41|3.18|||Regression, Logistic|||Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.18|0.41|0.8054
73911071|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9292|TWO_SIDED|95.0|0.22|3.98|||Regression, Logistic|||Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.98|0.22|0.9292
73911072|NCT02609828|147352478|SUPERIORITY|||||||0.9565|||||||Regression, Logistic|||Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9565
73911073|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|1.88||||0.1429|TWO_SIDED|95.0|0.81|4.36|||Regression, Logistic|||Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.36|0.81|0.1429
73911074|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|5.19||||0.014||95.0|1.4|19.31|||Regression, Logistic|||Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||19.31|1.40|0.0140
73911075|NCT02609828|147352478|SUPERIORITY|||||||0.945|||||||Regression, Logistic|||Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9450
73911076|NCT02609828|147352478|SUPERIORITY|||||||0.9489|||||||Regression, Logistic|||Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9489
73911077|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|1.63||||0.1932|TWO_SIDED|95.0|0.78|3.39|||Regression, Logistic|||Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.39|0.78|0.1932
73911078|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0254|TWO_SIDED|95.0|1.15|8.74|||Regression, Logistic|||Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||8.74|1.15|0.0254
73911079|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|5.0||||0.0455|TWO_SIDED|95.0|1.03|24.16|||Regression, Logistic|||Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||24.16|1.03|0.0455
73911080|NCT02609828|147352478|SUPERIORITY|||||||0.9464|||||||Regression, Logistic|||Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9464
73911081|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0969|TWO_SIDED|95.0|0.9|3.72|||Regression, Logistic|||Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.72|0.90|0.0969
73911082|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0043|TWO_SIDED|95.0|1.58|11.74|||Regression, Logistic|||Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||11.74|1.58|0.0043
74085406|NCT02618382|147724777|SUPERIORITY||||||<|0.05||||||Paired comparison of hematoma thickness at defined time point means determined by ANOVA for continuous variables.|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
73911083|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|5.49||||0.0352|TWO_SIDED|95.0|1.13|26.75|||Regression, Logistic|||Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||26.75|1.13|0.0352
73911084|NCT02609828|147352478|SUPERIORITY|||||||0.9464|||||||Regression, Logistic|||Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9464
73911085|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1471|TWO_SIDED|95.0|0.83|3.52|||Regression, Logistic|||Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.52|0.83|0.1471
73911086|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0405|TWO_SIDED|95.0|1.04|6.22|||Regression, Logistic|||Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.22|1.04|0.0405
73911087|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0993|TWO_SIDED|95.0|0.8|12.83|||Regression, Logistic|||Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||12.83|0.80|0.0993
73911088|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|4.71||||0.1726|TWO_SIDED|95.0|0.51|43.64|||Regression, Logistic|||Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||43.64|0.51|0.1726
73911089|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0918|TWO_SIDED|95.0|0.91|3.74|||Regression, Logistic|||Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.74|0.91|0.0918
73911090|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0704|TWO_SIDED|95.0|0.94|4.82|||Regression, Logistic|||Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.82|0.94|0.0704
73911091|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3569|TWO_SIDED|95.0|0.56|5.01|||Regression, Logistic|||Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.01|0.56|0.3569
73911092|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|2.46||||0.3062|TWO_SIDED|95.0|0.44|13.79|||Regression, Logistic|||Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||13.79|0.44|0.3062
73911093|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1058|TWO_SIDED|95.0|0.88|3.85|||Regression, Logistic|||Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.85|0.88|0.1058
73911094|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|1.81||||0.1571|TWO_SIDED|95.0|0.79|4.14|||Regression, Logistic|||Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.14|0.79|0.1571
73911095|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2454|TWO_SIDED|95.0|0.65|5.24|||Regression, Logistic|||Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.24|0.65|0.2454
73911096|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8867|TWO_SIDED|95.0|0.24|3.46|||Regression, Logistic|||Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.46|0.24|0.8867
73911097|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0689|TWO_SIDED|95.0|0.95|4.21|||Regression, Logistic|||Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.21|0.95|0.0689
73911098|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0568|TWO_SIDED|95.0|0.98|5.44|||Regression, Logistic|||Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.44|0.98|0.0568
73911099|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1268|TWO_SIDED|95.0|0.78|7.46|||Regression, Logistic|||Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||7.46|0.78|0.1268
73911100|NCT02609828|147352478|SUPERIORITY||Odds Ratio (OR)|1.23||||0.7971|TWO_SIDED|95.0|0.25|6.0|||Regression, Logistic|||Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.00|0.25|0.7971
73911101|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6658|TWO_SIDED|95.0|0.43|3.7|||Regression, Logistic|||Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.70|0.43|0.6658
73911102|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|3.07||||0.3443|TWO_SIDED|95.0|0.3|31.35|||Regression, Logistic|||Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||31.35|0.30|0.3443
73911103|NCT02609828|147352479|SUPERIORITY|||||||0.9527|||||||Regression, Logistic|||Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9527
73911104|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0757|TWO_SIDED|95.0|0.92|5.5|||Regression, Logistic|||Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.50|0.92|0.0757
73911105|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|4.51||||0.0659|TWO_SIDED|95.0|0.91|22.42|||Regression, Logistic|||Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||22.42|0.91|0.0659
73911106|NCT02609828|147352479|SUPERIORITY|||||||0.938|||||||Regression, Logistic|||Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9380
73911107|NCT02609828|147352479|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
73911108|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0914|TWO_SIDED|95.0|0.89|4.59|||Regression, Logistic|||Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.59|0.89|0.0914
73911109|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0359|TWO_SIDED|95.0|1.08|9.61|||Regression, Logistic|||Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||9.61|1.08|0.0359
73911110|NCT02609828|147352479|SUPERIORITY|||||||0.9538|||||||Regression, Logistic|||Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9538
73965012|NCT04714320|147465416|SUPERIORITY||||||=|0.29||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 43||||=0.290
73911111|NCT02609828|147352479|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
73911112|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0143|TWO_SIDED|95.0|1.22|5.8|||Regression, Logistic|||Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.80|1.22|0.0143
73911113|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0176|TWO_SIDED|95.0|1.28|13.74|||Regression, Logistic|||Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||13.74|1.28|0.0176
73911114|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|3.53||||0.1298|TWO_SIDED|95.0|0.69|18.06|||Regression, Logistic|||Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||18.06|0.69|0.1298
73911115|NCT02609828|147352479|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
73911116|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0527|TWO_SIDED|95.0|0.99|4.67|||Regression, Logistic|||Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.67|0.99|0.0527
73911117|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0457|TWO_SIDED|95.0|1.02|7.12|||Regression, Logistic|||Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||7.12|1.02|0.0457
73911118|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|3.91||||0.0994|TWO_SIDED|95.0|0.77|19.76|||Regression, Logistic|||Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||19.76|0.77|0.0994
73911119|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|0.65||||0.6977|TWO_SIDED|95.0|0.07|5.86|||Regression, Logistic|||Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.86|0.07|0.6977
73911120|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|1.76||||0.146|TWO_SIDED|95.0|0.82|3.75|||Regression, Logistic|||Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.75|0.82|0.1460
73911121|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|2.35||||0.0742|TWO_SIDED|95.0|0.92|6.01|||Regression, Logistic|||Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.01|0.92|0.0742
73911122|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5565|TWO_SIDED|95.0|0.42|4.91|||Regression, Logistic|||Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.91|0.42|0.5565
73911123|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|1.7||||0.5623|TWO_SIDED|95.0|0.28|10.35|||Regression, Logistic|||Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||10.35|0.28|0.5623
73911124|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|2.86||||0.0116|TWO_SIDED|95.0|1.27|6.47|||Regression, Logistic|||Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.47|1.27|0.0116
73965013|NCT04714320|147465416|SUPERIORITY||||||=|0.349||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 50||||=0.349
73965014|NCT04714320|147465416|SUPERIORITY||||||=|0.532||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 50||||=0.532
73911125|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0615|TWO_SIDED|95.0|0.96|5.7|||Regression, Logistic|||Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.70|0.96|0.0615
73911126|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|1.68||||0.3316|TWO_SIDED|95.0|0.59|4.8|||Regression, Logistic|||Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.80|0.59|0.3316
73965015|NCT04714320|147465416|SUPERIORITY||||||=|0.205||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 57||||=0.205
73911127|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9946|TWO_SIDED|95.0|0.19|5.33|||Regression, Logistic|||Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.33|0.19|0.9946
73911128|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0083|TWO_SIDED|95.0|1.33|6.76|||Regression, Logistic|||Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.76|1.33|0.0083
73911129|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|2.42||||0.0513|TWO_SIDED|95.0|1.0|5.88|||Regression, Logistic|||Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.88|1.00|0.0513
74026631|NCT00258154|147606775|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 10 mIU/mL greater than -10%|Percentage point difference|0.0|||<|0.001||95.0|-3.7|3.6|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq - Placebo)|||3.6|-3.7|<0.001
73911130|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1528|TWO_SIDED|95.0|0.71|8.58|||Regression, Logistic|||Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||8.58|0.71|0.1528
73911131|NCT02609828|147352479|SUPERIORITY||Odds Ratio (OR)|1.41||||0.7251|TWO_SIDED|95.0|0.21|9.65|||Regression, Logistic|||Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||9.65|0.21|0.7251
73911132|NCT02609828|147352480|SUPERIORITY||Difference in LS mean|-0.04|STANDARD_ERROR_OF_MEAN|0.12||0.7045|TWO_SIDED|95.0|-0.28|0.19|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.19|-0.28|0.7045
73911133|NCT02609828|147352480|SUPERIORITY||Difference in LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0402|TWO_SIDED|95.0|-0.59|-0.01|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||-0.01|-0.59|0.0402
73911134|NCT02609828|147352480|SUPERIORITY||Difference in LS mean|-0.33|STANDARD_ERROR_OF_MEAN|0.17||0.0637|TWO_SIDED|95.0|-0.67|0.02|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.02|-0.67|0.0637
73911135|NCT02609828|147352480|SUPERIORITY||Difference in LS mean|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.3804|TWO_SIDED|95.0|-0.53|0.2|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.20|-0.53|0.3804
73911136|NCT02609828|147352480|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5894|TWO_SIDED|95.0|-0.47|0.27|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.27|-0.47|0.5894
73911137|NCT02609828|147352481|SUPERIORITY||Odds Ratio (OR)|0.38||||0.2033|TWO_SIDED|95.0|0.09|1.69|||Regression, Logistic|||Week 2: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||1.69|0.09|0.2033
73911138|NCT02609828|147352481|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7627|TWO_SIDED|95.0|0.41|3.41|||Regression, Logistic|||Week 4: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.41|0.41|0.7627
73911139|NCT02609828|147352481|SUPERIORITY||Odds Ratio (OR)|1.23||||0.6894|TWO_SIDED|95.0|0.44|3.43|||Regression, Logistic|||Week 8: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.43|0.44|0.6894
73911140|NCT02609828|147352481|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5905|TWO_SIDED|95.0|0.47|3.83|||Regression, Logistic|||Week 16: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.83|0.47|0.5905
73911141|NCT02609828|147352481|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8354|TWO_SIDED|95.0|0.38|3.35|||Regression, Logistic|||Week 24: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.35|0.38|0.8354
73911142|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|-0.05|STANDARD_ERROR_OF_MEAN|0.22||0.8069|TWO_SIDED|95.0|-0.49|0.38|||Mixed Models Analysis|||Week 2 Frequency Composite Score: Mixed model for repeated measurements (MMRM) model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.38|-0.49|0.8069
73911143|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.7127|TWO_SIDED|95.0|-0.28|0.41|||Mixed Models Analysis|||Week 4 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.28|0.7127
73911144|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.3933|TWO_SIDED|95.0|-0.57|0.23|||Mixed Models Analysis|||Week 8 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.23|-0.57|0.3933
73965016|NCT04714320|147465416|SUPERIORITY||||||=|0.368||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 57||||=0.368
73965017|NCT04714320|147465416|SUPERIORITY||||||=|0.084||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 64||||=0.084
73965018|NCT04714320|147465416|SUPERIORITY||||||=|0.179||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 64||||=0.179
73911145|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5869|TWO_SIDED|95.0|-0.71|0.41|||Mixed Models Analysis|||Week 16 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.71|0.5869
73911146|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|-0.42|STANDARD_ERROR_OF_MEAN|0.3||0.1814|TWO_SIDED|95.0|-1.05|0.21|||Mixed Models Analysis|||Week 24 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.21|-1.05|0.1814
73911147|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|0.16|STANDARD_ERROR_OF_MEAN|0.15||0.2822|TWO_SIDED|95.0|-0.14|0.46|||Mixed Models Analysis|||Week 2 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.46|-0.14|0.2822
73911148|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.5795|TWO_SIDED|95.0|-0.23|0.41|||Mixed Models Analysis|||Week 4 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.23|0.5795
73965019|NCT04714320|147465416|SUPERIORITY||||||=|0.584||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 71||||=0.584
73965020|NCT04714320|147465416|SUPERIORITY||||||=|0.762||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 71||||=0.762
73965021|NCT04714320|147465416|SUPERIORITY||||||=|0.675||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 78||||=0.675
73965022|NCT04714320|147465416|SUPERIORITY||||||=|0.166||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 78||||=0.166
73965023|NCT04714320|147465416|SUPERIORITY||||||=|0.09||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 85||||=0.090
73911149|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.5486|TWO_SIDED|95.0|-0.42|0.22|||Mixed Models Analysis|||Week 8 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.22|-0.42|0.5486
73911150|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.3692|TWO_SIDED|95.0|-0.24|0.63|||Mixed Models Analysis|||Week 16 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.63|-0.24|0.3692
73911151|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4724|TWO_SIDED|95.0|-0.3|0.63|||Mixed Models Analysis|||Week 24 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.63|-0.30|0.4724
73911152|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.477|TWO_SIDED|95.0|-0.3|0.64|||Mixed Models Analysis|||Week 2 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.64|-0.30|0.4770
73965024|NCT04714320|147465416|SUPERIORITY||||||=|0.488||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 85||||=0.488
73965025|NCT04714320|147465416|SUPERIORITY||||||=|0.218||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 92||||=0.218
73965026|NCT04714320|147465416|SUPERIORITY||||||=|0.232||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 92||||=0.232
74085407|NCT02618382|147724778|OTHER||||||<|0.05||||||The P values for differences among time point means were determined by ANOVA for continuous variables and by chi-squared test for categorical values in grouped mRS scores.|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
74085408|NCT02445287|147724779|SUPERIORITY_OR_OTHER|||||||0.92||||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.920
73911153|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.9791|TWO_SIDED|95.0|-0.38|0.37|||Mixed Models Analysis|||Week 4 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.37|-0.38|0.9791
73911154|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3574|TWO_SIDED|95.0|-0.27|0.74|||Mixed Models Analysis|||Week 8 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.74|-0.27|0.3574
73911155|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.29||0.5607|TWO_SIDED|95.0|-0.77|0.42|||Mixed Models Analysis|||Week 16 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.42|-0.77|0.5607
73911156|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7143|TWO_SIDED|95.0|-0.68|0.47|||Mixed Models Analysis|||Week 24 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.47|-0.68|0.7143
73911157|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.18||0.6381|TWO_SIDED|95.0|-0.28|0.45|||Mixed Models Analysis|||Week 2 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.45|-0.28|0.6381
74085409|NCT02445287|147724780|SUPERIORITY_OR_OTHER|||||||0||||||Level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.000
74085410|NCT02445287|147724781|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval = (-0.25, 0.25)||||||0||||||level of significance (alpha) = 0.05|Equivalence test|||||||0.000
74085411|NCT02445287|147724782|SUPERIORITY_OR_OTHER|||||||0.012||||||level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.012
74085412|NCT03235479|147724783|SUPERIORITY||Risk Difference (RD)|4.9||||0.0298|TWO_SIDED|95.0|0.5|9.3|||Cochran-Mantel-Haenszel|||||9.3|0.5|0.0298
74085413|NCT03235479|147724784|SUPERIORITY||Risk Difference (RD)|8.9||||0.0016|TWO_SIDED|95.0|3.4|14.4|||Cochran-Mantel-Haenszel|||||14.4|3.4|0.0016
74085414|NCT03235479|147724785|SUPERIORITY||Risk Difference (RD)|10.2||||0.0005|TWO_SIDED|95.0|4.4|15.9|||Cochran-Mantel-Haenszel|||||15.9|4.4|0.0005
73965027|NCT04714320|147465416|SUPERIORITY||||||=|0.421||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 106||||=0.421
74085415|NCT03235479|147724786|SUPERIORITY||Risk Difference (RD)|7.7||||0.0299|TWO_SIDED|95.0|0.8|14.6|||Cochran-Mantel-Haenszel|||||14.6|0.8|0.0299
74085416|NCT03235479|147724787|SUPERIORITY||Risk Difference (RD)|10.3||||0.0006|TWO_SIDED|95.0|4.4|16.2|||Cochran-Mantel-Haenszel|||||16.2|4.4|0.0006
74085417|NCT03235479|147724788|SUPERIORITY||Risk Difference (RD)|5.2||||0.1815|TWO_SIDED|95.0|-2.4|12.9||P-value ≥ 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.9|-2.4|0.1815
74085418|NCT00309985|147724799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED||||||Log Rank|||The study was designed to detect a 33.3% improvement in median survival time across treatments with one-sided type I error of 0.025 and 80% power.||||0.0003
74085419|NCT00309985|147724800|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
74085420|NCT00309985|147724801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
73858177|NCT05032690|147261785|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|146.7|||||TWO_SIDED|90.0|117.88|182.58|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted."||182.58|117.88|
74085421|NCT00309985|147724802|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
74085422|NCT00309985|147724803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
73858178|NCT00350272|147261792|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-13.5|||||TWO_SIDED|95.0|-35.2|8.2||||||The difference in proportions between the group of participants who received lamivudine 300 mg/day (in combination with efavirenz and tenofovir) over 12 weeks and the group of participants who received elvucitabine 10 mg/day (in combination with efavirenz and tenofovir) over 12 weeks along with corresponding 2-sided 95% confidence interval for risk difference using asymptotic normal theory.||8.2|-35.2|
73858179|NCT03222973|147261819|SUPERIORITY||Treatment Difference|0.15||||0.1479|TWO_SIDED|95.0|-0.05|0.35||P-values are based on the Mixed Model for Repeated Measures (MMRM) adjusted for background DMT group, baseline magnetization transfer ratio (MTR)/diffusion tensor imaging (DTI) category and baseline component assessments.|MMRM|||Over 72 weeks: Overall Response Score||0.35|-0.05|0.1479
73858180|NCT03222973|147261821|SUPERIORITY||Odds Ratio (OR)|1.08||||0.7682|TWO_SIDED|95.0|0.65|1.79||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.79|0.65|0.7682
73858181|NCT03222973|147261822|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2131|TWO_SIDED|95.0|0.41|1.22||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.22|0.41|0.2131
73858182|NCT03222973|147261823|SUPERIORITY||Odds Ratio (OR)|0.81||||0.4654|TWO_SIDED|95.0|0.47|1.41||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.41|0.47|0.4654
73858183|NCT03222973|147261824|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0417|TWO_SIDED|95.0|1.02|3.11||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||3.11|1.02|0.0417
73858184|NCT03222973|147261825|SUPERIORITY||Odds Ratio (OR)|1.35||||0.2908|TWO_SIDED|95.0|0.78|2.33||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||2.33|0.78|0.2908
73858185|NCT02080481|147261837|SUPERIORITY_OR_OTHER||ratio of geometric means|0.68|||<|0.001|TWO_SIDED|95.0|0.61|0.76|||Regression, Linear|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the linear regression model.||||0.76|0.61|< 0.001
73858186|NCT02080481|147261838|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.56|TWO_SIDED|98.3|0.25|9.6|||Regression, Logistic|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the logistic regression model.|Odds ratio for Infiniti Plus versus conventional needle patients|||9.6|0.25|0.56
73858187|NCT02080481|147261839|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13||||0.06|TWO_SIDED|98.3|0.01|1.78||Intraoperative management strategy was imbalanced between groups and adjusted for in the logistic regression model.|Regression, Logistic|||||1.78|0.01|0.06
73858188|NCT02080481|147261840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.74|TWO_SIDED|98.3|-7.7|14.6|||Regression, Linear|Intraoperative management strategy was imbalanced between randomized groups and adjusted for in the linear regression model.||||14.6|-7.7|0.74
73858189|NCT05538312|147261841|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|168.9|||||TWO_SIDED|90.0|157.66|180.94|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUCinf was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||180.94|157.66|
73911158|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|0.06|STANDARD_ERROR_OF_MEAN|0.15||0.7181|TWO_SIDED|95.0|-0.25|0.37|||Mixed Models Analysis|||Week 4 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.37|-0.25|0.7181
73911159|NCT02609828|147352484|SUPERIORITY||Difference in least square (LS) mean|-0.04|STANDARD_ERROR_OF_MEAN|0.17||0.8378|TWO_SIDED|95.0|-0.38|0.31|||Mixed Models Analysis|||Week 8 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.31|-0.38|0.8378
73911160|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|-0.06|STANDARD_ERROR_OF_MEAN|0.23||0.795|TWO_SIDED|95.0|-0.52|0.4|||Mixed Models Analysis|||Week 16 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.40|-0.52|0.7950
73911161|NCT02609828|147352484|SUPERIORITY||Difference in LS mean|-0.11|STANDARD_ERROR_OF_MEAN|0.25||0.6719|TWO_SIDED|95.0|-0.62|0.4|||Mixed Models Analysis|||Week 24 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.40|-0.62|0.6719
73911162|NCT03758066|147352500|OTHER|||||||0.03||||||P-value reported for quality of life measured between baseline and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).||||.03
73965028|NCT04714320|147465416|SUPERIORITY||||||=|0.815||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 106||||=0.815
73965029|NCT04714320|147465416|SUPERIORITY||||||=|0.711||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 120||||=0.711
73965030|NCT04714320|147465416|SUPERIORITY||||||=|0.514||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 120||||=0.514
73965031|NCT04714320|147465416|SUPERIORITY||||||=|0.479||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 148||||=0.479
73965032|NCT04714320|147465416|SUPERIORITY||||||=|0.292||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 148||||=0.292
73965033|NCT04714320|147465416|SUPERIORITY||||||=|0.528||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 169||||=0.528
73965034|NCT04714320|147465416|SUPERIORITY||||||=|0.946||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 169||||=0.946
73911163|NCT03758066|147352501|SUPERIORITY|||||||0.02||||||P-value reported for self-reported self-efficacy in chronic disease management between baseline and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).||||.02
73911164|NCT03758066|147352501|OTHER|||||||0.02||||||P-value reported for self-reported self-efficacy in chronic disease management between 6- and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||||||.02
73911165|NCT00762385|147352505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03164|STANDARD_ERROR_OF_MEAN|0.1247||||98.3|-0.2346|0.03164|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.03164|-0.2346|
73965035|NCT04714320|147465416|SUPERIORITY||||||=|0.552||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 8||||=0.552
73965036|NCT04714320|147465416|SUPERIORITY||||||=|0.598||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 8||||=0.598
73965037|NCT04714320|147465416|SUPERIORITY||||||=|0.184||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 15||||=0.184
73911166|NCT00762385|147352506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.00556|STANDARD_ERROR_OF_MEAN|0.02287||||98.3|-0.04297|0.00556|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.005560|-0.04297|
73911167|NCT00762385|147352507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2726|STANDARD_ERROR_OF_MEAN|0.1064||||98.3|0.04553|0.2726|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.2726|0.04553|
73911168|NCT03863197|147352544|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
73911169|NCT03863197|147352545|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
73911170|NCT03863197|147352546|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
73911171|NCT03863197|147352547|SUPERIORITY||||||<|0.01||||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
73911172|NCT03863197|147352548|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
73911173|NCT03863197|147352549|SUPERIORITY||||||<|0.01||||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
73911174|NCT03863197|147352553|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
73911175|NCT03863197|147352554|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
73911176|NCT05338216|147352555|SUPERIORITY||Mean Difference (Final Values)|19.63||||0.021||95.0|4.37|36.24||Threshold for significance: p \< 0.05. No correction for multiple comparisons performed due to only two tests conducted and exploratory nature of this pilot study.|Wilcoxon (Mann-Whitney)|||Hypothesis: Compliance would be significantly higher for micro-interaction based versus traditional EMA. Null hypothesis: No difference between conditions.||36.24|4.37|0.021
73911177|NCT05338216|147352556|SUPERIORITY||Mean Difference (Final Values)|17.34||||0.027||95.0|0.78|32.77||Threshold for significance: p \< 0.05. No correction for multiple comparisons performed due to only two tests conducted and exploratory nature of this pilot study.|Wilcoxon (Mann-Whitney)|||Hypothesis: Completion would be significantly higher for micro-interaction based versus traditional EMA. Null hypothesis: No difference between conditions.||32.77|0.78|0.027
73911178|NCT01065597|147352559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|This was a paired t-test.||||||0.001
73911179|NCT01065597|147352560|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|This was a paired t-test.||||||>0.05
73911180|NCT01065597|147352562|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73911181|NCT03285984|147352574|SUPERIORITY||Mean Difference (Net)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.27|-0.15||From ANCOVA model with factors for treatment group, period and subject (random effect), and subject-level baseline and period-level baseline|ANCOVA||Difference is first named treatment minus second-named treatment such that a negative difference favors the first named treatment|||-0.15|-0.27|<.0001
73911182|NCT00413244|147352576|SUPERIORITY_OR_OTHER|||||||0.03|||||||log mean|||"Statistician used all the time points post-baseline together (Overall). The result gives the estimates and 95% CI of the treatment effect from longitudinal analyses (generalized estimating equation method) which basically pools data from all visits post-baseline."||||0.03
73911183|NCT04472429|147352604|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0006|TWO_SIDED|95.0|0.47|0.84||tested at the 1-sided 2.5% level|stratified log-rank test||A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.84|0.47|0.0006
73911184|NCT01172522|147352617|SUPERIORITY_OR_OTHER||Other|0.0|||=|1|TWO_SIDED||||||Chi-squared||P values above 0.05 is considered statistically insignificant in this study.|||||=1
73911185|NCT02319837|147352621|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.424|||<|0.0001|TWO_SIDED|95.0|0.296|0.607||Statistical significance can be declared if p-value \<0.05.|Log Rank|||||0.607|0.296|<0.0001
73911186|NCT02319837|147352622|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.631||||0.0049|TWO_SIDED|95.0|0.456|0.871||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.871|0.456|0.0049
73911187|NCT02319837|147352623|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.068|||<|0.0001|TWO_SIDED|95.0|0.033|0.141||Statistical significance can be declared if p-value \<0.02.|Log Rank|||||0.141|0.033|<0.0001
73911188|NCT02319837|147352623|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.331|||<|0.0001|TWO_SIDED|95.0|0.226|0.486||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.486|0.226|<0.0001
74085423|NCT00309985|147724804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0009
73911189|NCT02319837|147352624|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.358|||<|0.0001|TWO_SIDED|95.0|0.263|0.488||Statistical significance can be declared if p-value \<0.02.|Log Rank|||||0.488|0.263|<0.0001
73911190|NCT02319837|147352624|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.411|0.709||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.709|0.411|<0.0001
73911191|NCT02319837|147352626|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.443||||0.0002|TWO_SIDED|95.0|0.284|0.69|||Log Rank|||||0.690|0.284|0.0002
73911192|NCT02319837|147352626|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.614||||0.0171|TWO_SIDED|95.0|0.409|0.92|||Log Rank|||||0.920|0.409|0.0171
73911193|NCT02319837|147352627|OTHER||difference of percentage of participants|25.9|||<|0.0001|TWO_SIDED|95.0|20.7|31.0||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||31.0|20.7|<0.0001
73911194|NCT02319837|147352627|OTHER||difference of percentage of participants|18.8|||<|0.0001|TWO_SIDED|95.0|13.0|24.6||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||24.6|13.0|<0.0001
73911195|NCT02319837|147352628|OTHER||difference of percentage of participants|7.5||||0.0439|TWO_SIDED|95.0|-0.2|15.2||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||15.2|-0.2|0.0439
73911196|NCT02319837|147352628|OTHER||difference of percentage of participants|-12.9||||0.0004|TWO_SIDED|95.0|-19.8|-6.1||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||-6.1|-19.8|0.0004
73911197|NCT02319837|147352629|OTHER||difference of percentage of participants|7.2||||0.0089|TWO_SIDED|95.0|1.7|12.8||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||12.8|1.7|0.0089
73911198|NCT02319837|147352629|OTHER||difference of percentage of participants|-5.0||||0.0326|TWO_SIDED|95.0|-9.4|-0.6||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||-0.6|-9.4|0.0326
73911199|NCT02319837|147352630|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.693|||<|0.0001|TWO_SIDED|95.0|0.577|0.834|||Log Rank|||||0.834|0.577|<0.0001
73911200|NCT02319837|147352630|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.655|||<|0.0001|TWO_SIDED|95.0|1.381|1.984|||Log Rank|||||1.984|1.381|<0.0001
73911201|NCT02319837|147352631|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.09|||<|0.0001|TWO_SIDED|95.0|0.051|0.157|||Log Rank|||||0.157|0.051|<0.0001
73911202|NCT02319837|147352632|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.546|||<|0.0001|TWO_SIDED|95.0|0.427|0.699|||Log Rank|||||0.699|0.427|<0.0001
73911203|NCT02319837|147352632|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.619|||<|0.0001|TWO_SIDED|95.0|0.488|0.785|||Log Rank|||||0.785|0.488|<0.0001
73911204|NCT02319837|147352633|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.261||||0.0001|TWO_SIDED|95.0|0.125|0.548|||Log Rank|||||0.548|0.125|0.0001
73911205|NCT02319837|147352633|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.423||||0.0057|TWO_SIDED|95.0|0.226|0.794|||Log Rank|||||0.794|0.226|0.0057
74085424|NCT00309985|147724804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.40
73911206|NCT02319837|147352634|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|1.078||||0.4321|TWO_SIDED|95.0|0.894|1.301|||Log Rank|||||1.301|0.894|0.4321
73911207|NCT02319837|147352634|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.09||||0.3702|TWO_SIDED|95.0|0.904|1.314|||Log Rank|||||1.314|0.904|0.3702
73965038|NCT04714320|147465416|SUPERIORITY||||||=|0.614||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 15||||=0.614
73911208|NCT02319837|147352635|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|1.138||||0.1567|TWO_SIDED|95.0|0.954|1.357|||Log Rank|||||1.357|0.954|0.1567
73965039|NCT04714320|147465416|SUPERIORITY||||||=|0.933||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 22||||=0.933
73965040|NCT04714320|147465416|SUPERIORITY||||||=|0.803||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 22||||=0.803
73965041|NCT04714320|147465416|SUPERIORITY||||||=|0.686||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 29||||=0.686
73965042|NCT04714320|147465416|SUPERIORITY||||||=|0.752||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 29||||=0.752
73965043|NCT04714320|147465416|SUPERIORITY||||||=|0.106||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 36||||=0.106
73965044|NCT04714320|147465416|SUPERIORITY||||||=|0.779||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 36||||=0.779
73965045|NCT04714320|147465416|SUPERIORITY||||||=|0.323||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 43||||=0.323
73965046|NCT04714320|147465416|SUPERIORITY||||||=|0.991||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 43||||=0.991
73965047|NCT04714320|147465416|SUPERIORITY||||||=|0.973||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 50||||=0.973
73965048|NCT04714320|147465416|SUPERIORITY||||||=|0.23||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 50||||=0.230
73965049|NCT04714320|147465416|SUPERIORITY||||||=|0.792||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 57||||=0.792
73965050|NCT04714320|147465416|SUPERIORITY||||||=|0.744||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 57||||=0.744
73965051|NCT04714320|147465416|SUPERIORITY|Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|||||=|0.925|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 64||||=0.925
73965052|NCT04714320|147465416|SUPERIORITY||||||=|0.991||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 64||||=0.991
73965053|NCT04714320|147465416|SUPERIORITY|Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|||||=|0.53|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 71||||=0.530
73911209|NCT02319837|147352635|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.168||||0.0855|TWO_SIDED|95.0|0.981|1.391|||Log Rank|||||1.391|0.981|0.0855
73911210|NCT00660673|147352719|OTHER||||||<|0.001|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in off time was assessed for significance using a 1-sample paired t test"||||<0.001
73965054|NCT04714320|147465416|SUPERIORITY||||||=|0.849||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 71||||=0.849
73965055|NCT04714320|147465416|SUPERIORITY||||||=|0.953||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 78||||=0.953
73965056|NCT04714320|147465416|SUPERIORITY||||||=|0.884||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 78||||=0.884
73965057|NCT04714320|147465416|SUPERIORITY||||||=|0.23||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 85||||=0.230
73965058|NCT04714320|147465416|SUPERIORITY||||||=|0.589||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 85||||=0.589
73965059|NCT04714320|147465416|SUPERIORITY||||||=|0.919||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 92||||=0.919
73911211|NCT00660673|147352719|OTHER|||||||0.433|||||||One-sample t-test|||"Change from Baseline to end of study in off time was assessed for significance using a 1-sample paired t-test."||||0.433
73965060|NCT04714320|147465416|SUPERIORITY||||||=|0.753||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 92||||=0.753
73965061|NCT04714320|147465416|SUPERIORITY||||||=|0.747||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 106||||=0.747
73911212|NCT00660673|147352720|OTHER||||||<|0.001|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in on time without troublesome dyskinesia was assessed for significance using a 1-sample paired t-test."||||<0.001
73911213|NCT00660673|147352720|OTHER|||||||0.15|||||||One-sample t-test|||"Change from Baseline to end of study in on time without troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.150
73965062|NCT04714320|147465416|SUPERIORITY||||||=|0.764||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 106||||=0.764
73965063|NCT04714320|147465416|SUPERIORITY||||||=|0.527||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 120||||=0.527
73965064|NCT04714320|147465416|SUPERIORITY||||||=|0.639||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 120||||=0.639
73965065|NCT04714320|147465416|SUPERIORITY||||||=|0.744||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 148||||=0.744
73911214|NCT00660673|147352721|OTHER|||||||0.725|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in on time with troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.725
73911215|NCT00660673|147352721|OTHER|||||||0.019|||||||One-sample t-test|||"Change from Baseline to end of study in on time with troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.019
73911216|NCT01589978|147352729|NON_INFERIORITY_OR_EQUIVALENCE|Given the performance goal of 3.2%, with expected rate for PROMUS Element Plus of 2.2% and a one-sided 5% significance level, approximately 1,706 PLATINUM-like patients will provide at least 80% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||One-sided, single binomial test will be performed to compare observed rate against performance goal, the normal approximation of the test statistic will be used. The performance goal is met if the one-sided upper 95% confidence bound for the observed binary rate is less than performance goal.||||<.0001
73965066|NCT04714320|147465416|SUPERIORITY||||||=|0.539||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 148||||=0.539
73911217|NCT01589978|147352749|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is calculated for one-sample chi-square test for a single proportion using nQuery AdvisorVersion 5.0. The expected annual increase in ST rate is estimated to be 0.4% based on the current data available from the pooled TAXUS Express and pooled TAXUS Liberté data and the PG is 1.0% using a delta of 0.6%. Given a one-sided 5% significance level, a minimum of 1,660 PLATINUM-like patients at 5-yrs will be required to provide 90% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||The expected annual increase of stent thrombosis rate is assumed to be 0.4%, based on the observed increase in incidence rate of stent thrombosis of approximately 0.4% annually for PLATINUM-like patients in the pooled TAXUS SR Express and pooled TAXUS Liberté data. Using a delta of 0.6%, the performance goal is set to 1.0% (expected rate + delta = 0.4% + 0.6% = 1.0%).||||<.0001
73911218|NCT02993757|147352819|OTHER||GMT ratio|0.982|||||TWO_SIDED|95.0|0.664|1.45||||||Antigen HPV-6||1.45|0.664|
73911219|NCT02993757|147352819|OTHER||GMT ratio|0.804|||||TWO_SIDED|95.0|0.626|1.03||||||Antigen HPV-11||1.03|0.626|
74026632|NCT00258154|147606777|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 0.15 μg/mL greater than -10%.|Percentage point difference|-3.7||||0.015||95.0|-9.3|1.3|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq - Placebo)|||1.3|-9.3|0.015
74026633|NCT00754390|147606807|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium does not affect zinc absorption||||0.17
73911220|NCT02993757|147352819|OTHER||GMT ratio|0.815|||||TWO_SIDED|95.0|0.608|1.09||||||Antigen HPV-16||1.09|0.608|
73911221|NCT02993757|147352819|OTHER||GMT ratio|0.795|||||TWO_SIDED|95.0|0.603|1.05||||||Antigen HPV-18||1.05|0.603|
73911222|NCT02993757|147352820|OTHER||GMT ratio|0.987|||||TWO_SIDED|95.0|0.574|1.7||||||Serotype 1||1.70|0.574|
73911223|NCT02993757|147352820|OTHER||GMT ratio|0.783|||||TWO_SIDED|95.0|0.5|1.22||||||Serotype 2||1.22|0.500|
73911224|NCT02993757|147352820|OTHER||GMT ratio|0.836|||||TWO_SIDED|95.0|0.568|1.23||||||Serotype 3||1.23|0.568|
73911225|NCT02993757|147352820|OTHER||GMT ratio|1.07|||||TWO_SIDED|95.0|0.813|1.4||||||Serotype 4||1.40|0.813|
73911226|NCT01681472|147352834|SUPERIORITY|||||||0.0323|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0323
73911227|NCT01681472|147352834|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
73911228|NCT01681472|147352834|SUPERIORITY|||||||0.8622|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.8622
73911229|NCT01681472|147352834|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
73911230|NCT01681472|147352834|SUPERIORITY|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0074
73911231|NCT01681472|147352834|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
73911232|NCT01681472|147352835|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1480
73911233|NCT01681472|147352835|SUPERIORITY|||||||0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0034
73911234|NCT01681472|147352835|SUPERIORITY|||||||0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0177
73911235|NCT01681472|147352835|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
73911236|NCT01681472|147352835|SUPERIORITY|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0019
73911237|NCT01681472|147352835|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0118
73911238|NCT01681472|147352836|SUPERIORITY|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1182
73911239|NCT01681472|147352836|SUPERIORITY|||||||0.0538|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0538
73911240|NCT01681472|147352836|SUPERIORITY|||||||0.5244|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5244
74026634|NCT00754390|147606807|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary Phytate does not affect zinc absorption||||0.0002
73911241|NCT01681472|147352836|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
73911242|NCT01681472|147352836|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0313
73911243|NCT01681472|147352836|SUPERIORITY|||||||0.4777|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4777
73911244|NCT01681472|147352837|SUPERIORITY|||||||0.2716|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2716
73911245|NCT01681472|147352837|SUPERIORITY|||||||0.0124|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0124
73911246|NCT01681472|147352837|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
73911247|NCT01681472|147352837|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
73911248|NCT01681472|147352837|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0039
73911249|NCT01681472|147352837|SUPERIORITY|||||||0.0454|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0454
73911250|NCT01681472|147352838|SUPERIORITY|||||||0.0092|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0092
73911251|NCT01681472|147352838|SUPERIORITY|||||||0.8303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.8303
73911252|NCT01681472|147352838|SUPERIORITY|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1182
73911253|NCT01681472|147352838|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
73911254|NCT01681472|147352838|SUPERIORITY|||||||0.3184|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.3184
73911255|NCT01681472|147352838|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
73911256|NCT01681472|147352839|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
73911257|NCT01681472|147352839|SUPERIORITY|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2246
73911258|NCT01681472|147352839|SUPERIORITY|||||||0.0428|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0428
73911259|NCT01681472|147352839|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0003
73911260|NCT01681472|147352839|SUPERIORITY|||||||0.4309|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4309
73911261|NCT01681472|147352839|SUPERIORITY|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0055
73911262|NCT01681472|147352840|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
73911263|NCT01681472|147352840|SUPERIORITY|||||||0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0034
73911264|NCT01681472|147352840|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911265|NCT01681472|147352840|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
73911266|NCT01681472|147352840|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
73911267|NCT01681472|147352840|SUPERIORITY|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0055
73911268|NCT01681472|147352841|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
73911269|NCT01681472|147352841|SUPERIORITY|||||||0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0058
73911270|NCT01681472|147352841|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911271|NCT01681472|147352841|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
73911272|NCT01681472|147352841|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
73911273|NCT01681472|147352841|SUPERIORITY|||||||0.0338|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0338
73911274|NCT01681472|147352842|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911275|NCT01681472|147352842|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911276|NCT01681472|147352842|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911277|NCT01681472|147352842|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911278|NCT01681472|147352842|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911279|NCT01681472|147352842|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911280|NCT01681472|147352843|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911281|NCT01681472|147352843|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911282|NCT01681472|147352843|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911283|NCT01681472|147352843|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911284|NCT01681472|147352843|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
73911285|NCT01681472|147352843|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911286|NCT01681472|147352844|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
73911287|NCT01681472|147352844|SUPERIORITY|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2246
73911288|NCT01681472|147352844|SUPERIORITY|||||||0.0166|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0166
73911289|NCT01681472|147352844|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
73911290|NCT01681472|147352844|SUPERIORITY|||||||0.9581|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.9581
73911291|NCT01681472|147352844|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0118
73911292|NCT01681472|147352845|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911293|NCT01681472|147352845|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73965067|NCT04714320|147465416|SUPERIORITY||||||=|0.417||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 169||||=0.417
73911294|NCT01681472|147352845|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911295|NCT01681472|147352845|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911296|NCT01681472|147352845|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911297|NCT01681472|147352845|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
73911298|NCT01681472|147352846|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911299|NCT01681472|147352846|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911300|NCT01681472|147352846|SUPERIORITY|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0022
73965068|NCT04714320|147465416|SUPERIORITY||||||=|0.466||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 169||||=0.466
73911301|NCT01681472|147352846|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911302|NCT01681472|147352846|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911303|NCT01681472|147352846|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911304|NCT01681472|147352847|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911305|NCT01681472|147352847|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911306|NCT01681472|147352847|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911307|NCT01681472|147352847|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911308|NCT01681472|147352847|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
73911309|NCT01681472|147352847|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911310|NCT01681472|147352848|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
73911311|NCT01681472|147352848|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
73911312|NCT01681472|147352848|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911313|NCT01681472|147352848|SUPERIORITY|||||||0.2725|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2725
73911314|NCT01681472|147352848|SUPERIORITY|||||||0.1893|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1893
73911315|NCT01681472|147352848|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
73911316|NCT01681472|147352849|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911317|NCT01681472|147352849|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911318|NCT01681472|147352849|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911319|NCT01681472|147352849|SUPERIORITY|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0142
73911320|NCT01681472|147352849|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0085
73911321|NCT01681472|147352849|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
73911322|NCT01681472|147352850|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
73911323|NCT01681472|147352850|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911324|NCT01681472|147352850|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0021
73911325|NCT01681472|147352850|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911326|NCT01681472|147352850|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
73911327|NCT01681472|147352850|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911328|NCT01681472|147352851|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911329|NCT01681472|147352851|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911330|NCT01681472|147352851|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911331|NCT01681472|147352851|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911332|NCT01681472|147352851|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
73911333|NCT01681472|147352851|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911334|NCT01681472|147352852|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
73911335|NCT01681472|147352852|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
73911336|NCT01681472|147352852|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
73911337|NCT01681472|147352852|SUPERIORITY|||||||0.1551|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1551
73911338|NCT01681472|147352852|SUPERIORITY|||||||0.1563|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1563
73911339|NCT01681472|147352852|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
73911340|NCT01681472|147352853|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911341|NCT01681472|147352853|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911342|NCT01681472|147352853|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911343|NCT01681472|147352853|SUPERIORITY|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0142
73911344|NCT01681472|147352853|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0085
73911345|NCT01681472|147352853|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
73911346|NCT01681472|147352854|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||1.0000
73911347|NCT01681472|147352854|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
74026635|NCT00754390|147606807|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium and dietary phytate do not affect zinc absorption. Eight women were required to detect a difference in zinc absorption of 7 percentage points with a power of 90%, alpha level of 0.05.||||0.09
74026636|NCT03443024|147606894|SUPERIORITY|||||||0.0165|||||||ANCOVA|||||||0.0165
73911348|NCT01681472|147352854|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0010
73911349|NCT01681472|147352854|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911350|NCT01681472|147352854|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0005
73911351|NCT01681472|147352854|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911352|NCT01681472|147352855|SUPERIORITY|||||||0.0056|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0056
73911353|NCT01681472|147352855|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
74026637|NCT03443024|147606894|SUPERIORITY|||||||0.0022|TWO_SIDED|95.0|||||ANCOVA|||||||0.0022
73911354|NCT01681472|147352855|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0010
73911355|NCT01681472|147352855|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911356|NCT01681472|147352855|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
73911357|NCT01681472|147352855|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911358|NCT01681472|147352856|SUPERIORITY|||||||0.1796|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1796
73911359|NCT01681472|147352856|SUPERIORITY|||||||0.3243|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.3243
73911360|NCT01681472|147352856|SUPERIORITY|||||||0.0263|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0263
73965069|NCT04714320|147465416|SUPERIORITY||||||=|0.38||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 8||||=0.380
74026638|NCT03443024|147606894|SUPERIORITY|||||||0.0005|TWO_SIDED|95.0|||||ANCOVA|||||||0.0005
74026639|NCT03443024|147606895|SUPERIORITY|||||||0.061|||||||Cochran-Mantel-Haenszel|||||||0.0610
73911361|NCT01681472|147352856|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0268
73911362|NCT01681472|147352856|SUPERIORITY|||||||0.2041|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2041
73911363|NCT01681472|147352856|SUPERIORITY|||||||0.0061|||||||Wilcoxon (Mann-Whitney)|||||||0.0061
73911364|NCT01681472|147352857|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
74026640|NCT03443024|147606895|SUPERIORITY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||||||0.0021
74026641|NCT03443024|147606895|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||||||0.0005
74026642|NCT03443024|147606896|SUPERIORITY|||||||0.1917|||||||Cochran-Mantel-Haenszel|||||||0.1917
74026643|NCT03443024|147606896|SUPERIORITY|||||||0.0392|||||||Cochran-Mantel-Haenszel|||||||0.0392
74026644|NCT03443024|147606896|SUPERIORITY|||||||0.0023|||||||Cochran-Mantel-Haenszel|||||||0.0023
74026645|NCT03443024|147606897|SUPERIORITY|||||||0.2043|||||||Cochran-Mantel-Haenszel|||||||0.2043
74026646|NCT03443024|147606897|SUPERIORITY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||||||0.0021
74026647|NCT03443024|147606897|SUPERIORITY|||||||0.0018|||||||Cochran-Mantel-Haenszel|||||||0.0018
74026648|NCT03443024|147606898|SUPERIORITY|||||||0.0554|||||||Cochran-Mantel-Haenszel|||||||0.0554
74026649|NCT03443024|147606898|SUPERIORITY|||||||0.0037|||||||Cochran-Mantel-Haenszel|||||||0.0037
74026650|NCT03443024|147606898|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||||||0.0008
73911365|NCT01681472|147352857|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911366|NCT01681472|147352857|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911367|NCT01681472|147352857|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911368|NCT01681472|147352857|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911369|NCT01681472|147352857|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911370|NCT01681472|147352858|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0268
73911371|NCT01681472|147352858|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911372|NCT01681472|147352858|SUPERIORITY|||||||0.0227|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0227
74026651|NCT03443024|147606899|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|||||||0.0800
74026652|NCT03443024|147606899|SUPERIORITY|||||||0.0062|||||||Cochran-Mantel-Haenszel|||||||0.0062
74026653|NCT03443024|147606899|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||||||0.0006
73911373|NCT01681472|147352858|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911374|NCT01681472|147352858|SUPERIORITY|||||||0.0933|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0933
73911375|NCT01681472|147352858|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911376|NCT01681472|147352859|SUPERIORITY|||||||0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0177
73911377|NCT01681472|147352859|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911378|NCT01681472|147352859|SUPERIORITY|||||||0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0058
73911379|NCT01681472|147352859|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73965070|NCT04714320|147465416|SUPERIORITY||||||=|0.73||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 8||||=0.730
73965071|NCT04714320|147465416|SUPERIORITY||||||=|0.595||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 15||||=0.595
74026654|NCT03443024|147606900|SUPERIORITY|||||||0.0773|||||||ANCOVA|||||||0.0773
74026655|NCT03443024|147606900|SUPERIORITY|||||||0.0459|||||||ANCOVA|||||||0.0459
74026656|NCT03443024|147606900|SUPERIORITY|||||||0.0062|TWO_SIDED|95.0|||||ANCOVA|||||||0.0062
73911380|NCT01681472|147352859|SUPERIORITY|||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0043
74026657|NCT03443024|147606901|SUPERIORITY|||||||0.0047|||||||ANCOVA|||||||0.0047
74026658|NCT03443024|147606901|SUPERIORITY|||||||0.0002|TWO_SIDED|95.0|||||ANCOVA|||||||0.0002
74026659|NCT03443024|147606901|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74026660|NCT03443024|147606902|SUPERIORITY|||||||0.6674|||||||Cochran-Mantel-Haenszel|||||||0.6674
74026661|NCT03443024|147606902|SUPERIORITY|||||||0.1166|||||||Cochran-Mantel-Haenszel|||||||0.1166
74026662|NCT03443024|147606902|SUPERIORITY|||||||0.0119|||||||Cochran-Mantel-Haenszel|||||||0.0119
74026663|NCT03443024|147606903|SUPERIORITY|||||||0.2371|||||||Cochran-Mantel-Haenszel|||||||0.2371
74026664|NCT03443024|147606903|SUPERIORITY|||||||0.1067|||||||Cochran-Mantel-Haenszel|||||||0.1067
74026665|NCT03443024|147606903|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||||||0.0008
74026666|NCT03443024|147606904|SUPERIORITY|||||||0.4631|||||||ANCOVA|||||||0.4631
74026667|NCT03443024|147606904|SUPERIORITY|||||||0.0368|||||||ANCOVA|||||||0.0368
73911381|NCT01681472|147352859|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911382|NCT01681472|147352860|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
74026668|NCT03443024|147606904|SUPERIORITY|||||||0.0232|||||||ANCOVA|||||||0.0232
73911383|NCT01681472|147352860|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911384|NCT01681472|147352860|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911385|NCT01681472|147352860|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911386|NCT01681472|147352860|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911387|NCT01681472|147352860|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911388|NCT01681472|147352861|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911389|NCT01681472|147352861|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
74026669|NCT03443024|147606905|SUPERIORITY|||||||0.4729|||||||ANCOVA|||||||0.4729
73911390|NCT01681472|147352861|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911391|NCT01681472|147352861|SUPERIORITY|||||||0.0668|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0668
73911392|NCT01681472|147352861|SUPERIORITY|||||||0.0502|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0502
73911393|NCT01681472|147352861|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
73911394|NCT01681472|147352862|SUPERIORITY|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0011
73911395|NCT01681472|147352862|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911396|NCT01681472|147352862|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
74026670|NCT03443024|147606905|SUPERIORITY|||||||0.0282|||||||ANCOVA|||||||0.0282
73911397|NCT01681472|147352862|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911398|NCT01681472|147352862|SUPERIORITY|||||||0.6691|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.6691
73911399|NCT01681472|147352862|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911400|NCT01681472|147352863|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
74026671|NCT03443024|147606905|SUPERIORITY|||||||0.0506|||||||ANCOVA|||||||0.0506
74026672|NCT00624338|147606908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.518|TWO_SIDED|95.0|0.74|1.82||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic|||||1.82|0.74|0.518
74026673|NCT00624338|147606908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.003|TWO_SIDED|95.0|0.31|0.78||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||0.78|0.31|0.003
74026674|NCT00624338|147606909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984||||0.929|TWO_SIDED|95.0|0.69|1.4||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox|||||1.40|0.69|0.929
73911401|NCT01681472|147352863|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911402|NCT01681472|147352863|SUPERIORITY|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0640
73911403|NCT01681472|147352863|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911404|NCT01681472|147352863|SUPERIORITY|||||||0.1213|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1213
73911405|NCT01681472|147352863|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911406|NCT01681472|147352864|SUPERIORITY|||||||0.1791|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1791
73911407|NCT01681472|147352864|SUPERIORITY|||||||0.4945|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4945
73911408|NCT01681472|147352864|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
73911409|NCT01681472|147352864|SUPERIORITY|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5990
73911410|NCT01681472|147352864|SUPERIORITY|||||||0.0303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0303
73911411|NCT01681472|147352864|SUPERIORITY|||||||0.0107|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0107
73911412|NCT01681472|147352865|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911413|NCT01681472|147352865|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911414|NCT01681472|147352865|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
73911415|NCT01681472|147352865|SUPERIORITY|||||||0.0125|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0125
73911416|NCT01681472|147352865|SUPERIORITY|||||||0.0017|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0017
73911417|NCT01681472|147352865|SUPERIORITY|||||||0.5286|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5286
73911418|NCT01681472|147352866|OTHER||Correlation factor|-0.21666||||0.6063|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.6063
73911419|NCT01681472|147352866|OTHER||Correlation factor|0.54039||||0.2105|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.2105
73911420|NCT01681472|147352866|OTHER||Correlation factor|0.27618||||0.5079|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.5079
73911421|NCT01681472|147352866|OTHER||Correlation factor|0.68223||||0.0913|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.0913
73911422|NCT01681472|147352867|OTHER||Correlation factor|0.38298||||0.3964|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.3964
73911423|NCT01681472|147352867|OTHER||Correlation factor|0.27018||||0.5175|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.5175
73911424|NCT01681472|147352867|OTHER||Correlation factor|-0.02188||||0.959|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.9590
73911425|NCT01681472|147352867|OTHER||Correlation factor|0.45404||||0.3061|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3061
73911426|NCT01681472|147352867|OTHER||Correlation factor|0.34905||||0.3967|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3967
73911427|NCT01681472|147352867|OTHER||Correlation factor|0.07937||||0.8518|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.8518
73911428|NCT01681472|147352868|OTHER||Correlation factor|0.73743||||0.0586|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.0586
73911429|NCT01681472|147352868|OTHER||Correlation factor|0.44757||||0.2661|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.2661
73911430|NCT01681472|147352868|OTHER||Correlation factor|0.03292||||0.9506|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.9506
73911431|NCT01681472|147352868|OTHER||Correlation factor|0.09033||||0.8315|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.8315
73911432|NCT01681472|147352868|OTHER||Correlation factor|0.76502||||0.0451|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in adjacent mucosa||||0.0451
73911433|NCT01681472|147352868|OTHER||Correlation factor|0.34496||||0.4027|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.4027
73911434|NCT01681472|147352868|OTHER||Correlation factor|-0.66295||||0.1513|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.1513
73911435|NCT01681472|147352868|OTHER||Correlation factor|0.36854||||0.369|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3690
73911436|NCT01681472|147352869|OTHER||Correlation factor|0.23512||||0.5751|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.5751
73911437|NCT01681472|147352869|OTHER||Correlation factor|0.02576||||0.9672|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.9672
73911438|NCT01681472|147352869|OTHER||Correlation factor|0.68778||||0.0594|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.0594
73911439|NCT01681472|147352869|OTHER||Correlation factor|0.11512||||0.8281|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.8281
73911440|NCT01681472|147352870|OTHER|||||||0.0451|||||||pearson|||||||0.0451
73911441|NCT01681472|147352871|OTHER||Correlation factor|0.42972||||0.3359|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.3359
73911442|NCT01681472|147352871|OTHER||Correlation factor|0.75404||||0.0307|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.0307
73911443|NCT01681472|147352871|OTHER||Correlation factor|-0.7073||||0.116|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.1160
73911444|NCT01681472|147352871|OTHER||Correlation factor|-0.47193||||0.2377|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.2377
73911445|NCT01681472|147352871|OTHER||Correlation factor|0.88128||||0.0087|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.0087
73911446|NCT01681472|147352871|OTHER||Correlation factor|0.58502||||0.1277|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.1277
73911447|NCT01681472|147352871|OTHER||Correlation factor|0.89976||||0.0146|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.0146
73911448|NCT01681472|147352871|OTHER||Correlation factor|0.11497||||0.7863|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.7863
73911449|NCT01681472|147352871|OTHER||Correlation factor|0.97624||||0.0002|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.0002
73911450|NCT01681472|147352871|OTHER||Correlation factor|0.88682||||0.0033|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.0033
73911451|NCT01681472|147352871|OTHER||Correlation factor|-0.64743||||0.1645|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.1645
73911452|NCT01681472|147352871|OTHER||Correlation factor|0.17664||||0.6756|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.6756
73911453|NCT01681472|147352871|OTHER||Correlation factor|0.94364||||0.0014|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.0014
73911454|NCT01681472|147352871|OTHER||Correlation factor|0.43194||||0.2852|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.2852
73911455|NCT01681472|147352871|OTHER||Correlation factor|0.58419||||0.2234|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.2234
73911456|NCT01681472|147352871|OTHER||Correlation factor|0.9584||||0.0002|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.0002
73911457|NCT01681472|147352871|OTHER||Correlation factor|-0.38987||||0.3873|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.3873
73911458|NCT01681472|147352871|OTHER||Correlation factor|-0.25891||||0.5358|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.5358
73911459|NCT01681472|147352871|OTHER||Correlation factor|0.777||||0.0691|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.0691
73911460|NCT01681472|147352871|OTHER||Correlation factor|0.00322||||0.994|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.9940
73911461|NCT01681472|147352871|OTHER||Correlation factor|0.93711||||0.0018|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.0018
73911462|NCT01681472|147352871|OTHER||Correlation factor|0.46883||||0.2413|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.2413
73911463|NCT01681472|147352871|OTHER||Correlation factor|-0.09737||||0.8544|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.8544
73911464|NCT01681472|147352871|OTHER||Correlation factor|0.78928||||0.0199|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.0199
73911465|NCT01681472|147352871|OTHER||Correlation factor|0.82963||||0.0209|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.0209
73911466|NCT01681472|147352871|OTHER||Correlation factor|-0.16724||||0.6922|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.6922
73965072|NCT04714320|147465416|SUPERIORITY||||||=|0.279||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 15||||=0.279
73911467|NCT01681472|147352871|OTHER||Correlation factor|0.14436||||0.785|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.7850
73911468|NCT01681472|147352871|OTHER||Correlation factor|0.74757||||0.033|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.0330
73911469|NCT01681472|147352871|OTHER||Correlation factor|0.32113||||0.4825|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.4825
73911470|NCT01681472|147352871|OTHER||Correlation factor|0.3716||||0.3647|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.3647
73911471|NCT01681472|147352871|OTHER||Correlation factor|0.20955||||0.6903|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.6903
73911472|NCT01681472|147352871|OTHER||Correlation factor|0.74459||||0.0341|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.0341
73911473|NCT01681472|147352871|OTHER||Correlation factor|0.50966||||0.2426|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.2426
73911474|NCT01681472|147352871|OTHER||Correlation factor|0.67853||||0.0643|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.0643
73911475|NCT01681472|147352871|OTHER||Correlation factor|0.05531||||0.9171|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.9171
73911476|NCT01681472|147352871|OTHER||Correlation factor|0.59183||||0.1222|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.1222
73911477|NCT01681472|147352871|OTHER||Correlation factor|0.8104||||0.0271|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.0271
73911478|NCT01681472|147352871|OTHER||Correlation factor|0.86266||||0.0058|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.0058
73911479|NCT01681472|147352871|OTHER||Correlation factor|-0.71666||||0.109|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.1090
73911480|NCT01681472|147352871|OTHER||Correlation factor|0.55508||||0.1533|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.1533
73911481|NCT01681472|147352871|OTHER||Correlation factor|0.318||||0.487|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.4870
73911482|NCT01681472|147352871|OTHER||Correlation factor|0.23312||||0.5785|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.5785
73911483|NCT01681472|147352871|OTHER||Correlation factor|-0.0245||||0.9632|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.9632
73911484|NCT01681472|147352871|OTHER||Correlation factor|0.64565||||0.0838|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.0838
73911485|NCT02012283|147352877|OTHER|paired t-test|Mean Difference (Final Values)|78.4||||0.001|TWO_SIDED|95.0||||p\<0.05 is defined as significant|t-test, 2 sided|||Difference between plain and spiced broccoli intake was compared.||||0.001
73911486|NCT02012283|147352878|OTHER|paired t-test|Mean Difference (Final Values)|101.3||||0.031|TWO_SIDED|||||p\<0.05 is defined as significant.|t-test, 2 sided|||Comparison was made to the broccoli intake with and without spices among low restraint eaters vs. the change among high restraint eaters.||||0.031
73911487|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 0.5 hour post-dose||3.64|-0.7|
73911488|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||||90.0|-5.13|-0.79||||||Inferential analysis at 1 hour post-dose||-0.79|-5.13|
73911489|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.53||||||90.0|-7.7|-3.36||||||Inferential analysis at 2 hour post-dose||-3.36|-7.70|
73911490|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||||90.0|-1.77|2.57||||||Inferential analysis at 4 hour post-dose||2.57|-1.77|
73911491|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||||90.0|-3.54|0.8||||||Inferential analysis at 8 hour post-dose||0.80|-3.54|
73911492|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||||90.0|-1.16|3.18||||||Inferential analysis at 12 hour post-dose||3.18|-1.16|
73911493|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||||90.0|-2.81|1.53||||||Inferential analysis at 24 hour post-dose||1.53|-2.81|
73911494|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49||||||90.0|0.32|4.66||||||Inferential analysis at 0.5 hour post-dose||4.66|0.32|
73911495|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||||90.0|-3.95|0.39||||||Inferential analysis at 1 hour post-dose||0.39|-3.95|
73911496|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51||||||90.0|-9.68|-5.34||||||Inferential analysis at 2 hour post-dose||-5.34|-9.68|
73911497|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.47||||||90.0|1.3|5.64||||||Inferential analysis at 4 hour post-dose||5.64|1.30|
73911498|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13||||||90.0|-1.04|3.3||||||Inferential analysis at 8 hour post-dose||3.30|-1.04|
73911499|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 12 hour post-dose||3.64|-0.70|
73911500|NCT00795145|147352885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||||90.0|-0.37|3.97||||||Inferential analysis at 24 hour post-dose||3.97|-0.37|
73911501|NCT00795145|147352886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27||||||90.0|1.1|5.44||||||Inferential analysis at 0.5 hour post-dose||5.44|1.10|
73911502|NCT00795145|147352886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83||||||90.0|4.66|9.0||||||Inferential analysis at 1 hour post-dose||9.00|4.66|
73911503|NCT00795145|147352886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.27||||||90.0|8.1|12.44||||||Inferential analysis at 2 hour post-dose||12.44|8.10|
73911504|NCT00795145|147352886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.84||||||90.0|7.67|12.01||||||Inferential analysis at 4 hour post-dose||12.01|7.67|
73911505|NCT00795145|147352886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4||||||90.0|7.23|11.58||||||Inferential analysis at 8 hour post-dose||11.58|7.23|
73911506|NCT00795145|147352886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05||||||90.0|4.87|9.22||||||Inferential analysis at 12 hour post-dose||9.22|4.87|
73911507|NCT00795145|147352886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.52||||||90.0|4.35|8.69||||||Inferential analysis at 24 hour post-dose||8.69|4.35|
73911508|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||||90.0|-5.54|2.57||||||Inferential analysis at 0.5 hour post-dose||2.57|-5.54|
73911509|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.45||||||90.0|-11.51|-3.4||||||Inferential analysis at 1 hour post-dose||-3.40|-11.51|
73911510|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.75||||||90.0|-9.81|-1.7||||||Inferential analysis at 2 hour post-dose||-1.70|-9.81|
73911511|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||||90.0|-4.97|3.13||||||Inferential analysis at 4 hour post-dose||3.13|-4.97|
73911512|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.64||||||90.0|-9.69|-1.58||||||Inferential analysis at 8 hour post-dose||-1.58|-9.69|
73911513|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||||90.0|-6.34|1.77||||||Inferential analysis at 12 hour post-dose||1.77|-6.34|
73911514|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||||90.0|-4.64|3.47||||||Inferential analysis at 24 hour post-dose||3.47|-4.64|
73911515|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49||||||90.0|-7.54|0.57||||||Inferential analysis at 0.5 hour post-dose||0.57|-7.54|
73911516|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.19||||||90.0|-16.24|-8.13||||||Inferential analysis at 1 hour post-dose||-8.13|-16.24|
73911517|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.39||||||90.0|-18.44|-10.33||||||Inferential analysis at 2 hour post-dose||-10.33|-18.44|
73911518|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19||||||90.0|-6.24|1.87||||||Inferential analysis at 4 hour post-dose||1.87|-6.24|
73911519|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||||90.0|-2.95|5.15||||||Inferential analysis at 8 hour post-dose||5.15|-2.95|
73911520|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||||90.0|-3.94|4.17||||||Inferential analysis at 12 hour post-dose||4.17|-3.94|
73911521|NCT00795145|147352887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.68||||||90.0|-1.37|6.73||||||Inferential analysis at 24 hour post-dose||6.73|-1.37|
73911522|NCT03128411|147352914|SUPERIORITY||||||<|0.0001|||||||z-test, 1-sided|||With a sample size of 60 participants, study was powered at \>82% to test null hypothesis: true MMR rate at 12 months (48 weeks) is 25% versus alternative hypothesis: true MMR rate is 40% with one-sided alpha of 5%.||||<0.0001
73911523|NCT06934993|147352981|SUPERIORITY||||||<|0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||<0.001
73911524|NCT06934993|147352982|SUPERIORITY|||||||0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In all cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.001
73911525|NCT06934993|147352982|SUPERIORITY|||||||0.096||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.096
73911526|NCT06934993|147352982|SUPERIORITY||||||<|0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||<0.001
73911527|NCT06934993|147352983|SUPERIORITY|||||||0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.001
73911528|NCT06934993|147352983|SUPERIORITY|||||||0.096||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.096
73965073|NCT04714320|147465416|SUPERIORITY||||||=|0.196||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 22||||=0.196
73965074|NCT04714320|147465416|SUPERIORITY||||||=|0.728||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 22||||=0.728
73965075|NCT04714320|147465416|SUPERIORITY||||||=|0.453||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 29||||=0.453
73911529|NCT06934993|147352984|SUPERIORITY|||||||0.04||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.04
73911530|NCT06934993|147352984|SUPERIORITY|||||||0.679||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.679
73965076|NCT04714320|147465416|SUPERIORITY||||||=|0.681||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 29||||=0.681
73911531|NCT06934993|147352984|SUPERIORITY|||||||0.011||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.011
73911532|NCT00739674|147352995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0|||||Fisher Exact|||||||0.118
73911533|NCT00739674|147352996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||Fisher Exact|||||||0.092
73911534|NCT00739674|147352997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0|||||Fisher Exact|||||||0.122
73911535|NCT00739674|147352998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||95.0|||||Fisher Exact|||||||0.434
73911536|NCT00739674|147352999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.507
73965077|NCT04714320|147465416|SUPERIORITY||||||=|0.863||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 36||||=0.863
73911537|NCT00739674|147353000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.058
73911538|NCT00739674|147353001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.158
73911539|NCT00739674|147353002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.064
73911540|NCT00739674|147353003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.262
73911541|NCT00739674|147353004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.026
73911542|NCT00739674|147353005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212||95.0|||||Log Rank|||||||0.212
73911543|NCT01594281|147353006|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.8||||0.0344|TWO_SIDED|95.0|-5.4|-0.2|||ANCOVA|||||-0.2|-5.4|0.0344
73911544|NCT01594281|147353006|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-1.2||||0.3809|TWO_SIDED|95.0|-3.8|1.5|||ANCOVA|||||1.5|-3.8|0.3809
73911545|NCT01594281|147353006|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|1.7||||0.2113|TWO_SIDED|95.0|-1.0|4.3|||ANCOVA|||||4.3|-1.0|0.2113
73911546|NCT01594281|147353007|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.4||||0.0081|TWO_SIDED|95.0|-4.2|-0.6|||ANCOVA|||||-0.6|-4.2|0.0081
73911547|NCT01594281|147353007|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-0.3||||0.7494|TWO_SIDED|95.0|-2.0|1.5|||ANCOVA|||||1.5|-2.0|0.7494
73911548|NCT01594281|147353007|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|2.1||||0.0175|TWO_SIDED|95.0|0.4|3.9|||ANCOVA|||||3.9|0.4|0.0175
73911549|NCT01594281|147353008|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|5.5||||0.0495|TWO_SIDED|95.0|0.0|11.0|||ANCOVA|||||11.0|0.0|0.0495
73911550|NCT01594281|147353008|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|3.0||||0.2767|TWO_SIDED|95.0|-2.5|8.5|||ANCOVA|||||8.5|-2.5|0.2767
73911551|NCT01594281|147353008|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.5||||0.3641|TWO_SIDED|95.0|-7.9|2.9|||ANCOVA|||||2.9|-7.9|0.3641
73911552|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.47||||0.4019|TWO_SIDED|95.0|0.08|2.749|||Regression, Logistic|||≥10 letters gain||2.749|0.080|0.4019
73911553|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.833||||0.2772|TWO_SIDED|95.0|0.614|5.471|||Regression, Logistic|||≥5 letters gain||5.471|0.614|0.2772
73911554|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.412||||0.4731|TWO_SIDED|95.0|0.55|3.622|||Regression, Logistic|||No clinically relevant change||3.622|0.55|0.4731
73911555|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.35||||0.065|TWO_SIDED|95.0|0.155|1.068|||Regression, Logistic|||≥5 letters loss||1.068|0.155|0.065
73911556|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.229|4.361|||Regression, Logistic|||≥10 letters loss||4.361|0.229|1.000
73911557|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.314||||0.3261|TWO_SIDED|95.0|0.031|3.173|||Regression, Logistic|||≥15 letters loss||3.173|0.031|0.3261
73911558|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.667||||0.668|TWO_SIDED|95.0|0.104|4.253|||Regression, Logistic|||≥10 letters gain||4.253|0.104|0.6680
73911559|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|2.842||||0.0838|TWO_SIDED|95.0|0.87|9.283|||Regression, Logistic|||≥5 letters gain||9.283|0.870|0.0838
73911560|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.674||||0.4116|TWO_SIDED|95.0|0.263|1.729|||Regression, Logistic|||No clinically relevant change||1.729|0.263|0.4116
73911561|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.621||||0.4197|TWO_SIDED|95.0|0.195|1.977|||Regression, Logistic|||≥5 letters loss||1.977|0.195|0.4197
73911562|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|TWO_SIDED|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss||6.856|0.294|0.6632
73911563|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.029||||0.9839|TWO_SIDED|95.0|0.062|17.127|||Regression, Logistic|||≥15 letters loss||17.127|0.062|0.9839
73911564|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.663|TWO_SIDED|95.0|0.294|6.858|||Regression, Logistic|||≥10 letters gain||6.858|0.294|0.6630
73911565|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.55||||0.4941|TWO_SIDED|95.0|0.441|5.444||P-value was calculated as a point estimate.|Regression, Logistic|||≥5 letters gain||5.444|0.441|0.4941
73911566|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.477||||0.1259|TWO_SIDED|95.0|0.185|1.231|||Regression, Logistic|||No clinically relevant change||1.231|0.185|0.1259
73911567|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.773||||0.271|TWO_SIDED|95.0|0.64|4.913|||Regression, Logistic|||≥5 letters loss||4.913|0.640|0.2710
73911568|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|TWO_SIDED|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss||6.856|0.294|0.6632
73911569|NCT01594281|147353009|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|3.282||||0.314|TWO_SIDED|95.0|0.325|33.171|||Regression, Logistic|||≥15 letters loss||33.171|0.325|0.3140
73911570|NCT01594281|147353010|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.994||||0.9918|TWO_SIDED|95.0|0.327|3.026|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||3.026|0.327|0.9918
73911571|NCT01594281|147353010|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.607||||0.3595|TWO_SIDED|95.0|0.209|1.765|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||1.765|0.209|0.3595
73911572|NCT01594281|147353010|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.611||||0.3787|TWO_SIDED|95.0|0.204|1.83|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||1.830|0.204|0.3787
73911573|NCT01594281|147353010|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.889||||0.9097|TWO_SIDED|95.0|0.116|6.806|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||6.806|0.116|0.9097
73911574|NCT01594281|147353010|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.341||||0.223|TWO_SIDED|95.0|0.06|1.925|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||1.925|0.060|0.2230
73911575|NCT01594281|147353010|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.383||||0.2792|TWO_SIDED|95.0|0.068|2.177|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||2.177|0.068|0.2792
73911576|NCT01594281|147353011|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-40.7||||0.0003|TWO_SIDED|95.0|-62.1|-19.3|||ANCOVA|||||-19.3|-62.1|0.0003
73911577|NCT01594281|147353011|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-22.9||||0.0357|TWO_SIDED|95.0|-44.2|-1.6|||ANCOVA|||||-1.6|-44.2|0.0357
74026675|NCT00624338|147606909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.562||||0.009|TWO_SIDED|95.0|0.36|0.87||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||0.87|0.36|0.009
73911578|NCT01594281|147353011|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|17.8||||0.1034|TWO_SIDED|95.0|-3.7|39.3|||ANCOVA|||||39.3|-3.7|0.1034
73911579|NCT01594281|147353012|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-51.7||||0.0007|TWO_SIDED|95.0|-81.1|-22.3|||ANCOVA|||||-22.3|-81.1|0.0007
73911580|NCT01594281|147353012|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-28.9||||0.0542|TWO_SIDED|95.0|-58.4|0.5|||ANCOVA|||||0.5|-58.4|0.0542
73911581|NCT01594281|147353012|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|22.8||||0.1288|TWO_SIDED|95.0|-6.7|52.3|||ANCOVA|||||52.3|-6.7|0.1288
73911582|NCT00283400|147353037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.05|||<|0.05|TWO_SIDED|95.0|0.65|14.1|||Mixed Models Analysis|Post-hoc comparison of outcomes in dosage tier 1 vs dosage tier 2.||||14.1|0.65|<0.05
74088352|NCT03686150|147730149|OTHER|This was a population PK analysis of 25(OH)D after oral administration of Vitamin D.||||||||||||||||Part 1 of this study was to perform a population PK analysis of 25(OH)D after oral administration of Vitamin D in children who are overweight or obese and have asthma. Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.|Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.|||
73911583|NCT01709513|147353038|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.6|-24.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-24.2|-36.6|<0.0001
73911584|NCT01709513|147353039|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.1|||<|0.0001|TWO_SIDED|95.0|-40.7|-29.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.||-29.5|-40.7|<0.0001
73911585|NCT01709513|147353040|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-31.5|||<|0.0001|TWO_SIDED|95.0|-36.9|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-26.1|-36.9|<0.0001
73911586|NCT01709513|147353041|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-33.1|||<|0.0001|TWO_SIDED|95.0|-38.0|-28.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-28.2|-38.0|<0.0001
73911587|NCT01709513|147353042|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-29.8|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.4|-29.8|<0.0001
73911588|NCT01709513|147353043|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|95.0|-32.1|-24.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-24.4|-32.1|<0.0001
73911589|NCT01709513|147353044|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-30.4|-20.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.8|-30.4|<0.0001
73911590|NCT01709513|147353045|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-33.9|-25.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.8|-33.9|<0.0001
73911591|NCT01709513|147353046|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.8|||<|0.0001|TWO_SIDED|95.0|-24.7|-17.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-17.0|-24.7|<0.0001
73911592|NCT01709513|147353047|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.5|||<|0.0001|TWO_SIDED|95.0|-28.7|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.4|-28.7|<0.0001
74026676|NCT00624338|147606910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.215||||0.412|TWO_SIDED|95.0|0.76|1.94||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic|||||1.94|0.76|0.412
74026677|NCT00624338|147606910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.722||||0.198|TWO_SIDED|95.0|0.44|1.19||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||1.19|0.44|0.198
74026678|NCT05593432|147606920|SUPERIORITY||Response Rate Difference|29.4|STANDARD_ERROR_OF_MEAN|11.17||0.0129|TWO_SIDED|95.0|7.55|51.33||stratified by Baseline Investigator's Global Assessment (IGA) score (3 or 4)|Cochran-Mantel-Haenszel||stratified by Baseline IGA score (3 or 4)|||51.33|7.55|0.0129
73911593|NCT01709513|147353048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.7|||<|0.0001|TWO_SIDED|95.0|-29.9|-21.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.5|-29.9|<0.0001
73911594|NCT01709513|147353049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-24.5|-17.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-17.7|-24.5|<0.0001
73911595|NCT01709513|147353050|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|19.5|||<|0.0001|TWO_SIDED|95.0|6.9|55.2||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||55.2|6.9|<0.0001
73911596|NCT01709513|147353051|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|24.9|||<|0.0001|TWO_SIDED|95.0|8.6|71.9||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||71.9|8.6|<0.0001
73911597|NCT01709513|147353052|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|71.5|||<|0.0001|TWO_SIDED|95.0|11.1|3022.1||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a last observation carried forward (LOCF) approach followed by Exact conditional logistic regression model.||3022.1|11.1|<0.0001
73911598|NCT01709513|147353053|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|109.8|||<|0.0001|TWO_SIDED|95.0|16.5|4759.3||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a LOCF approach followed by Exact conditional logistic regression model.||4759.3|16.5|<0.0001
73911599|NCT01709513|147353054|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-18.7|||<|0.0001|TWO_SIDED|95.0|-25.5|-11.8||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-11.8|-25.5|<0.0001
73911600|NCT01709513|147353055|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.9|||=|0.6997|TWO_SIDED|95.0|-3.8|5.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||5.6|-3.8|=0.6997
73911601|NCT03166735|147353065|OTHER||Predicted mean daily dose in mg|3.45|STANDARD_ERROR_OF_MEAN|0.1|||||||||non-linear regression||The model fit used power of mean variance estimates (POM) to account for heterogeneity.|D10: Estimated dose reaching \<=10% activity the first time.||||
73911602|NCT03166735|147353067|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0212||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0212
74026679|NCT05593432|147606920|SUPERIORITY||Odds Ratio (OR)|4.04|||||TWO_SIDED|95.0|1.32|12.38|||||stratified by Baseline IGA score (3 or 4)|||12.38|1.32|
73911603|NCT03166735|147353068|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.127||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.1270
73911604|NCT03166735|147353069|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.3324||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.3324
73911605|NCT03166735|147353070|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.129||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.1290
73911606|NCT03166735|147353071|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0042||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0042
73911607|NCT03166735|147353072|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0728||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0728
74026680|NCT05593432|147606921|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Response Rate Difference|30.6|STANDARD_ERROR_OF_MEAN|11.68||0.0141|TWO_SIDED|95.0|7.71|53.51|||Cochran-Mantel-Haenszel|stratified by Baseline IGA score (3 or 4)||||53.51|7.71|0.0141
74026681|NCT05593432|147606921|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Odds Ratio (OR)|4.16|||||TWO_SIDED|95.0|1.31|13.17|||||stratified by Baseline IGA score (3 or 4)|||13.17|1.31|
74088353|NCT03686150|147730150|OTHER|This is one-sample test of proportion testing the null hypothesis that the proportion of participants with 25(OH)D level \>= 40 ng/mL is 50%.||||||0.0001|||||||z-test|||This is a one-sample test of proportion.||||0.0001
73911608|NCT01543958|147353073|SUPERIORITY_OR_OTHER|||||||0.87||||||not adjusted for multiple comparisons|Sign test|no other adjustment||||||0.87
73911609|NCT01543958|147353074|SUPERIORITY_OR_OTHER|||||||0.62||||||Not adjusted for multiple comparisons|Sign test|no other adjustment||||||0.62
73911610|NCT01519271|147353156|SUPERIORITY||Cohen's D|0.35|||||TWO_SIDED|||||||||||||
73911611|NCT02555683|147353165|SUPERIORITY||rate ratio|1.04||||0.8|TWO_SIDED|95.0|0.77|1.41||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure||||1.41|0.77|0.800
73911612|NCT02555683|147353165|SUPERIORITY||Rate Ratio|0.83||||0.51|TWO_SIDED|95.0|0.61|1.14||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure||||1.14|0.61|0.510
73911613|NCT02555683|147353166|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.095||0.819|TWO_SIDED|95.0|-0.11|0.26||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.26|-0.11|0.819
73911614|NCT02555683|147353166|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.095||0.591|TWO_SIDED|95.0|-0.05|0.32||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.32|-0.05|0.591
73911615|NCT02555683|147353167|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.098||0.819|TWO_SIDED|95.0|-0.31|0.07||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.07|-0.31|0.819
73911616|NCT02555683|147353167|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.098||0.591|TWO_SIDED|95.0|-0.37|0.02||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.02|-0.37|0.591
73911617|NCT02555683|147353168|SUPERIORITY||Mean Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.0365||0.8|TWO_SIDED|95.0|-0.005|0.139||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.139|-0.005|0.800
73911618|NCT02555683|147353168|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.0363||0.523|TWO_SIDED|95.0|-0.021|0.121||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.121|-0.021|0.523
73911619|NCT02555683|147353169|SUPERIORITY||rate ratio|0.96||||0.819|TWO_SIDED|95.0|0.75|1.22||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure||||1.22|0.75|0.819
73911620|NCT02555683|147353169|SUPERIORITY||Rate Ratio|0.78||||0.51|TWO_SIDED|95.0|0.61|1.01||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure||||1.01|0.61|0.510
73911621|NCT02555683|147353170|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.076||0.819|TWO_SIDED|95.0|-0.07|0.23||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.23|-0.07|0.819
73911622|NCT02555683|147353170|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.076||0.591|TWO_SIDED|95.0|-0.03|0.27||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.27|-0.03|0.591
73911623|NCT02555683|147353171|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.079||0.819|TWO_SIDED|95.0|-0.27|0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.04|-0.27|0.819
73911624|NCT02555683|147353171|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.079||0.591|TWO_SIDED|95.0|-0.35|-0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||-0.04|-0.35|0.591
73911625|NCT02555683|147353172|SUPERIORITY||Mean Difference (Net)|0.076|STANDARD_ERROR_OF_MEAN|0.0292||0.819|TWO_SIDED|95.0|0.019|0.134||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.134|0.019|0.819
73911626|NCT02555683|147353172|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.0292||0.591|TWO_SIDED|95.0|-0.017|0.097||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.097|-0.017|0.591
73911627|NCT04572633|147353184|OTHER||Wilson Score|95.5|||||TWO_SIDED|95.0|83.72|100.0|||||Bootstrap sampling with replacement method to account for potential within-subject lesion correlations. Subject is the bootstrap sampling unit, 1,000,000 iterations for bootstrap resampling, and the bias-corrected and accelerated method was used.|||100|83.72|
73911628|NCT04572633|147353185|OTHER||Wilson Score|6.8|||||TWO_SIDED|95.0|2.35|18.23||||||||18.23|2.35|
73911629|NCT00434954|147353278|NON_INFERIORITY_OR_EQUIVALENCE|The planned sample size of 366 patients treated with metformin only (assuming 25% dropouts) gave a power of 85% to detect non-inferiority of exenatide BID for change in HbA1c (non-inferiority margin 0.4%; assumed common standard deviation of 1.1%).|Mean Difference (Net)|0.14||||0.055|TWO_SIDED|95.0|-0.003|0.291||Non-inferiority: upper limit of 95% Confidence Interval (CI) to be \< 0.4%.|Mixed effect model repeat measures(MMRM)|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects); p-value: superiority test||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart 70/30 BID for glycemic control (change in HbA1c, outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2). This is the first part of the hierarchical test.||0.291|-0.003|0.055
73911630|NCT00434954|147353279|SUPERIORITY_OR_OTHER|||||||0.554||95.0|||||Chi square test (Pearson)|||||||0.554
73911631|NCT00434954|147353280|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Chi square test (Pearson)|||||||0.159
74026682|NCT05593432|147606923|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Response Rate Difference|40.3|STANDARD_ERROR_OF_MEAN|12.09||0.0027|TWO_SIDED|95.0|16.61|64.0|||Cochran-Mantel-Haenszel|stratified by Baseline IGA score (3 or 4)||||64.00|16.61|0.0027
74026683|NCT05593432|147606923|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Odds Ratio (OR)|6.67|||||TWO_SIDED|95.0|1.85|24.02|||||stratified by Baseline IGA score (3 or 4)|||24.02|1.85|
74026684|NCT05593432|147606925|EQUIVALENCE|A log-rank test stratified by randomization stratification factor, Baseline IGA score (3 or 4), was used for between-treatment group comparisons. The hazard ratio and its 95% confidence interval was estimated based on the stratified Cox regression model. using Efron's method accounting for ties.|Hazard Ratio (HR)|2.85||||0.0008|TWO_SIDED|95.0|1.51|5.381|||Log Rank|stratified by Baseline IGA score (3 or 4) between ruxolitinib 1.5% cream and vehicle cream|Cox regression model stratified by Baseline IGA score (3 or 4) was conducted to compare the difference in hazard rate between ruxolitinib 1.5% cream and vehicle cream|||5.381|1.510|0.0008
74088354|NCT03694808|147730153|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|ratio of GMT (Fluzone/Fluad)|1.23|||||TWO_SIDED|95.0|0.8|1.89|||t-test, 2 sided|||Statistical Analysis for Year 1 (2018-2019)||1.89|0.8|
73858190|NCT05538312|147261842|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|152.19|||||TWO_SIDED|90.0|136.9|169.18|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.18|136.90|
73858191|NCT05538312|147261843|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|161.99|||||TWO_SIDED|90.0|148.7|176.47|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUC120 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||176.47|148.70|
73858192|NCT05538312|147261844|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|153.13|||||TWO_SIDED|90.0|138.51|169.3|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.30|138.51|
73858193|NCT05538312|147261845|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|171.63|||||TWO_SIDED|90.0|159.96|184.15|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||184.15|159.96|
73858194|NCT05538312|147261846|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|157.8|||||TWO_SIDED|90.0|146.51|169.95|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUC120 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.95|146.51|
73858195|NCT05538312|147261851|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|192.86|||||TWO_SIDED|90.0|178.86|207.94|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||207.94|178.86|
73858196|NCT01263015|147261864|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \> -10%.|Difference in percentage|7.3||||0.003|TWO_SIDED|95.0|2.3|12.2||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||12.2|2.3|0.003
73858197|NCT01263015|147261866|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \> -10%.|Difference in percentage|7.1||||0.016|TWO_SIDED|95.0|1.2|13.1||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 96:The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||13.1|1.2|0.016
73858198|NCT01263015|147261866|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \>-10%.|Difference in percentage|8.3||||0.01|TWO_SIDED|95.0|1.9|14.6||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 144:Estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||14.6|1.9|0.010
73858199|NCT01263015|147261869|NON_INFERIORITY_OR_EQUIVALENCE|Adjusted mean is the estimated mean change from baseline (BL) in CD4 + Cell Count at Week 144 in each arm calculated from a repeated measures model including the following covariates: treatment, visit, BL plasma HIV-1 RNA, BL CD4 cell count, treatment\*visit interaction, BL HIV-1 RNA\*visit interaction and BL CD4 cell count\*visit interaction. No assumptions were made about the correlations between a par.'s readings of CD4 i.e. the correlation matrix for within-subject errors is unstructured.||||||0.003||95.0||||P-value is for the test of superiority.|Repeated Measure Mixed Model|||||||0.003
73858200|NCT00303446|147261881|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Generalized estimating equation model|The analysis includes percent change from baseline at 12 and 24 months.||||||0.28
73858201|NCT00303446|147261882|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.86
73858202|NCT00303446|147261883|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||Comparison of changes from baseline in manual muscle testing results.||||0.47
73858203|NCT00303446|147261884|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.13
73858204|NCT00303446|147261885|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.46
73911632|NCT00434954|147353285|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Non overlapping 95% CI's: statistically significant difference p\<0.05.|Kaplan-Meier analysis|For each treatment group, the incidence of hypoglycemia at Week 26 and 95% CIs were derived from Kaplan-Meier analysis.||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart BID for glycemic control (outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2).The planned sample size of 366 patients treated with metformin only (assumed dropout rate 25%) gave 96% power to detect superiority of exenatide BID for the risk of hypoglycemia, assuming incidences of 3.6% for exenatide BID and 17.5% for insulin aspart BID (alpha=0.05).||||<0.05
73911633|NCT00434954|147353286|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at baseline \>= 6.5% and \<= 8.0% vs. \> 8.0% and \<=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)||||||<0.0001
73911634|NCT00434954|147353287|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at Visit 1 \>= 6.5% and \<= 8.0% vs. \> 8.0% and \<=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)||||||<0.0001
73911635|NCT00944671|147353293|NON_INFERIORITY_OR_EQUIVALENCE|Given a 3-period crossover design, assuming a true within subject variance for natural log AUC of 0.029, 24 subjects completing the study, and alpha = 0.05, there is a 0.995 probability that the 90% confidence interval for the true geometric mean ratio of AUC for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.05||||||90.0|0.98|1.13||||||||1.13|0.98|
73911636|NCT00944671|147353294|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a true within subject variance for natural log Cmax of 0.017, there is a 0.999 probability that the 90% confidence interval for the true geometric mean ratio of Cmax for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.13||||||||1.13|0.93|
73911637|NCT00944671|147353295|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.05||||||90.0|0.98|1.13||||||||1.13|0.98|
73911638|NCT00944671|147353296|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03||||||90.0|0.93|1.14||||||||1.14|0.93|
73911639|NCT01431989|147353316|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|90.03|STANDARD_DEVIATION|7.53||0|TWO_SIDED|90.0|86.99|93.17|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.17|86.99|0.0000
73911640|NCT01431989|147353317|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|87.93|STANDARD_DEVIATION|13.83||0.0018|TWO_SIDED|90.0|82.55|93.65|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.65|82.55|0.0018
73911641|NCT01431989|147353318|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric means T/R formulation|90.03|STANDARD_DEVIATION|7.51||0|TWO_SIDED|90.0|86.96|93.12|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.12|86.96|0.0000
73911642|NCT01431989|147353319|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Median Difference (Final Values)|0.125||||0.339|TWO_SIDED|90.0|-0.125|0.375|||Wilcoxon (Mann-Whitney)|The non-parametric method included the following factors: Sequence, Formulation, Period, Formulation and Residual||||0.375|-0.125|0.3390
73911643|NCT03345914|147353325|SUPERIORITY||Percentage difference|18.1|||=|0.0004|TWO_SIDED|95.0|8.28|27.97||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kilograms (kg) or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with IGA 0 or 1 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||27.97|8.28|= 0.0004
73911644|NCT03345914|147353325|SUPERIORITY||Percentage difference|21.4|||<|0.0001|TWO_SIDED|95.0|11.36|31.45||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with IGA 0 or 1 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||31.45|11.36|< 0.0001
74026685|NCT03476850|147606937|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.883|TWO_SIDED||||||Mixed Models Analysis|||An a priori sample size calculation found 24 subjects per group (48 total) provided \>80% power to detect a 2 unit difference in patient reported pain based on a 2-sided test and significance level a = 0.05 assuming at least 3 measures per subject and a within subject covariance having a compound symmetric structure with a standard deviation in pain score of 3 units and within subject correlation of 0.5.||||.883
74026686|NCT03476850|147606938|SUPERIORITY||Median Difference (Final Values)|0.25||||0.977|TWO_SIDED||||||ANOVA|||||||.977
74026687|NCT03476850|147606939|SUPERIORITY||Odds Ratio (OR)|4.9||||0.009|TWO_SIDED||||||Chi-squared|||||||.009
73911645|NCT03345914|147353326|SUPERIORITY||Percentage difference|40.4|||<|0.0001|TWO_SIDED|95.0|28.95|51.82||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with EASI-75 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||51.82|28.95|< 0.0001
73911646|NCT03345914|147353326|SUPERIORITY||Percentage difference|42.8|||<|0.0001|TWO_SIDED|95.0|31.54|54.15||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with EASI-75 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||54.15|31.54|< 0.0001
73911647|NCT03345914|147353327|SUPERIORITY||Least Square Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-36.33|-23.24||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-23.24|-36.33|< 0.0001
73911648|NCT03345914|147353327|SUPERIORITY||Least Square Mean Difference|-33.4|||<|0.0001|TWO_SIDED|95.0|-40.06|-26.82||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-26.82|-40.06|< 0.0001
73911649|NCT03345914|147353328|SUPERIORITY||Least Square Mean Difference|-31.0|||<|0.0001|TWO_SIDED|95.0|-38.76|-23.26||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-23.26|-38.76|< 0.0001
73911650|NCT03345914|147353328|SUPERIORITY||Least Square Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-36.47|-20.82||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-20.82|-36.47|< 0.0001
73911651|NCT03345914|147353329|SUPERIORITY||Percentage difference|46.4|||<|0.0001|TWO_SIDED|95.0|35.3|57.42||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||57.42|35.3|< 0.0001
73911652|NCT03345914|147353329|SUPERIORITY||Percentage difference|39.2|||<|0.0001|TWO_SIDED|95.0|27.88|50.51||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||50.51|27.88|< 0.0001
73965078|NCT04714320|147465416|SUPERIORITY||||||=|0.837||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 36||||=0.837
73965079|NCT04714320|147465416|SUPERIORITY||||||=|0.504||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 43||||=0.504
73965080|NCT04714320|147465416|SUPERIORITY||||||=|0.531||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 43||||=0.531
73965081|NCT04714320|147465416|SUPERIORITY||||||=|0.6||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 50||||=0.600
73965082|NCT04714320|147465416|SUPERIORITY||||||=|0.83||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 50||||=0.830
74026688|NCT03476850|147606941|SUPERIORITY||Median Difference (Final Values)|18.0||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.110
73911653|NCT03345914|147353330|SUPERIORITY||Percentage difference|46.0|||<|0.0001|TWO_SIDED|95.0|35.47|56.61||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||56.61|35.47|< 0.0001
73911654|NCT03345914|147353330|SUPERIORITY||Percentage difference|38.5|||<|0.0001|TWO_SIDED|95.0|27.86|49.21||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||49.21|27.86|< 0.0001
73911655|NCT03345914|147353331|SUPERIORITY||Percentage difference|39.7|||<|0.0001|TWO_SIDED|95.0|28.68|50.72||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||50.72|28.68|< 0.0001
73911656|NCT03345914|147353331|SUPERIORITY||Percentage difference|47.9|||<|0.0001|TWO_SIDED|95.0|37.77|58.01||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||58.01|37.77|< 0.0001
73911657|NCT03345914|147353332|SUPERIORITY||Percentage difference|23.0|||<|0.0001|TWO_SIDED|95.0|13.65|32.38||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||32.38|13.65|< 0.0001
73911658|NCT03345914|147353332|SUPERIORITY||Percentage difference|34.5|||<|0.0001|TWO_SIDED|95.0|24.6|44.37||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||44.37|24.6|< 0.0001
73911659|NCT03345914|147353333|SUPERIORITY||Hazard ratios|3.114|||<|0.0001|TWO_SIDED|95.0|2.097|4.624||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||4.624|2.097|< 0.0001
73911660|NCT03345914|147353333|SUPERIORITY||Hazard ratios|2.921|||<|0.0001|TWO_SIDED|95.0|1.957|4.36||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||4.36|1.957|< 0.0001
74026689|NCT03476850|147606942|SUPERIORITY||Median Difference (Final Values)|0.26||||0.719|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.719
73965083|NCT04714320|147465416|SUPERIORITY||||||=|0.209||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 57||||=0.209
74026690|NCT04458857|147606966|OTHER||LS mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.44||0.021|TWO_SIDED|95.0|-1.9|-0.16|||ANCOVA|||||-0.16|-1.90|0.0210
74026691|NCT01151137|147607014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.294||||0.0019|TWO_SIDED|95.0|1.337|3.936||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for stroke, systemic arterial embolism, myocardial infarction or cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||3.936|1.337|0.0019
73911661|NCT03345914|147353334|SUPERIORITY||Hazard ratios|2.278|||<|0.0001|TWO_SIDED|95.0|1.631|3.182||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||3.182|1.631|< 0.0001
73911662|NCT03345914|147353334|SUPERIORITY||Hazard ratios|2.075|||<|0.0001|TWO_SIDED|95.0|1.481|2.908||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||2.908|1.481|< 0.0001
73911663|NCT03345914|147353335|SUPERIORITY||Least Square Mean Difference|-17.72|||<|0.0001|TWO_SIDED|95.0|-22.272|-13.161||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-13.161|-22.272|< 0.0001
73911664|NCT03345914|147353335|SUPERIORITY||Least Square Mean Difference|-18.88|||<|0.0001|TWO_SIDED|95.0|-23.479|-14.289||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-14.289|-23.479|< 0.0001
73911665|NCT03345914|147353336|SUPERIORITY||Least Square Mean Difference|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.3|-24.48||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-24.48|-36.3|< 0.0001
73911666|NCT03345914|147353336|SUPERIORITY||Least Square Mean Difference|-32.6|||<|0.0001|TWO_SIDED|95.0|-38.57|-26.59||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-26.59|-38.57|< 0.0001
73911667|NCT03345914|147353337|SUPERIORITY||Least Square Mean Difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-5.62|-2.99||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.99|-5.62|< 0.0001
73911668|NCT03345914|147353337|SUPERIORITY||Least Square Mean Difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.89||The confidence interval (CI) with p-value was based on treatment difference (dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.89|-5.57|< 0.0001
73911669|NCT03345914|147353338|SUPERIORITY||Least Square Mean Difference|-8.1|||<|0.0001|TWO_SIDED|95.0|-9.96|-6.31||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-6.31|-9.96|< 0.0001
74026692|NCT01151137|147607015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.947|||<|0.0001|TWO_SIDED|95.0|1.448|2.617||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for unscheduled cardiovascular hospitalization or death from any cause~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||2.617|1.448|<0.0001
73911670|NCT03345914|147353338|SUPERIORITY||Least Square Mean Difference|-8.3|||<|0.0001|TWO_SIDED|95.0|-10.13|-6.43||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-6.43|-10.13|< 0.0001
73911671|NCT03345914|147353339|SUPERIORITY||Least Square Mean Difference|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.984|-1.831||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-1.831|-2.984|< 0.0001
73911672|NCT03345914|147353339|SUPERIORITY||Least Square Mean Difference|-2.18|||<|0.0001|TWO_SIDED|95.0|-2.754|-1.599||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-1.599|-2.754|< 0.0001
73911673|NCT03345914|147353340|SUPERIORITY||Least Square Mean Difference|-4.11|||<|0.0001|TWO_SIDED|95.0|-5.434|-2.796||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.796|-5.434|< 0.0001
73911674|NCT03345914|147353340|SUPERIORITY||Least Square Mean Difference|-3.98|||<|0.0001|TWO_SIDED|95.0|-5.298|-2.657||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.657|-5.298|< 0.0001
73911675|NCT03345914|147353341|SUPERIORITY||Least Square Mean Difference|-3.37|||=|0.0061|TWO_SIDED|95.0|-5.779|-0.962||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.962|-5.779|= 0.0061
73911676|NCT03345914|147353341|SUPERIORITY||Least Square Mean Difference|-3.02|||=|0.0133|TWO_SIDED|95.0|-5.414|-0.629||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.629|-5.414|= 0.0133
73911677|NCT03345914|147353342|SUPERIORITY||Least Square Mean Difference|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.734|-2.272||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.272|-6.734|< 0.0001
74085425|NCT03110380|147724809|NON_INFERIORITY|A sample size of 260 participants per treatment group would provide at least 90% power to detect a non-inferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the two treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|-0.7|||||TWO_SIDED|95.001|-2.8|1.0|||||The differences in percentages of participants between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the B/F/TAF group is at least 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL as determined by the US FDA-defined snapshot algorithm at Week 48; the alternative hypothesis was that the B/F/TAF group is less than 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48.||1.0|-2.8|
74085426|NCT03110380|147724809|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
73911678|NCT03345914|147353342|SUPERIORITY||Least Square Mean Difference|-5.42|||<|0.0001|TWO_SIDED|95.0|-7.641|-3.207||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-3.207|-7.641|< 0.0001
73911679|NCT03345914|147353343|SUPERIORITY||Percentage Differenece|-4.8|||=|0.222|TWO_SIDED|95.0|-12.49|2.87||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||2.87|-12.49|= 0.222
74088355|NCT03694808|147730153|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.95|||||TWO_SIDED|95.0|0.66|1.38|||t-test, 2 sided|||Statistical Analysis for Year 2 (2019-2020)||1.38|0.66|
73911680|NCT03345914|147353343|SUPERIORITY||Percentage Differenece|-7.3|||=|0.0508|TWO_SIDED|95.0|-14.51|-0.03||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.03|-14.51|= 0.0508
73911681|NCT03345914|147353346|SUPERIORITY||Least Square Mean Difference|-5.7|||=|0.003|TWO_SIDED|95.0|-9.49|-1.96||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANOVA model with the treatment, randomization strata as fixed factors.|ANOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level||-1.96|-9.49|= 0.003
73911682|NCT03345914|147353346|SUPERIORITY|A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level|Least Square Mean Difference|-5.1|||=|0.0082|TWO_SIDED|95.0|-8.8|-1.31||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANOVA model with the treatment, randomization strata as fixed factors.|ANOVA|||||-1.31|-8.8|= 0.0082
73911683|NCT00885846|147353414|NON_INFERIORITY_OR_EQUIVALENCE|Regression analysis performed for equal variance at baseline.||||||0.664||95.0|||||Repeated ANOVA|degrees of freedom = 2||Power analysis suggested 27 participants, 9 in each group.||||0.664
73911684|NCT01786668|147353424|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.8|||||TWO_SIDED|95.0|5.0|30.3|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||30.3|5.0|
73911685|NCT01786668|147353424|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.9|||||TWO_SIDED|95.0|8.4|37.7|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||37.7|8.4|
73911686|NCT01786668|147353424|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.3|||||TWO_SIDED|95.0|10.7|43.4|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||43.4|10.7|
73911687|NCT01786668|147353425|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.75|STANDARD_ERROR_OF_MEAN|9.77||0.271|TWO_SIDED|95.0|-8.41|29.9|||Normal approximation for two proportions|||||29.90|-8.41|0.271
73911688|NCT01786668|147353425|SUPERIORITY_OR_OTHER||Risk Difference (RD)|39.59|STANDARD_ERROR_OF_MEAN|8.8|<|0.001|TWO_SIDED|95.0|22.35|56.83|||Normal approximation for two proportions|||||56.83|22.35|<0.001
73911689|NCT01786668|147353425|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.59|STANDARD_ERROR_OF_MEAN|9.74||0.134|TWO_SIDED|95.0|-4.5|33.69|||Normal approximation for two proportions|||||33.69|-4.50|0.134
73911690|NCT01786668|147353426|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.93|STANDARD_ERROR_OF_MEAN|9.24||0.162|TWO_SIDED|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 2||31.04|-5.17|0.162
73911691|NCT01786668|147353426|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.24|STANDARD_ERROR_OF_MEAN|9.02||0.561|TWO_SIDED|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 2||22.92|-12.44|0.561
73911692|NCT01786668|147353426|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 2||24.97|-10.65|0.430
73911693|NCT01786668|147353426|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.74|STANDARD_ERROR_OF_MEAN|9.57||0.123|TWO_SIDED|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4||33.50|-4.01|0.123
73911694|NCT01786668|147353426|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.44|STANDARD_ERROR_OF_MEAN|9.54||0.019|TWO_SIDED|95.0|3.74|41.13|||Normal approximation for two proportions|||Week 4||41.13|3.74|0.019
73911695|NCT01786668|147353426|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.74|STANDARD_ERROR_OF_MEAN|9.57||0.123|TWO_SIDED|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4||33.50|-4.01|0.123
73911696|NCT01786668|147353426|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.56|STANDARD_ERROR_OF_MEAN|9.75||0.135|TWO_SIDED|95.0|-4.55|33.66|||Normal approximation for two proportions|||Week 8||33.66|-4.55|0.135
73911697|NCT01786668|147353426|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.02|STANDARD_ERROR_OF_MEAN|9.36||0.003|TWO_SIDED|95.0|9.68|46.36|||Normal approximation for two proportions|||Week 8||46.36|9.68|0.003
73911698|NCT01786668|147353426|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.71|STANDARD_ERROR_OF_MEAN|9.79||0.274|TWO_SIDED|95.0|-8.48|29.9|||Normal approximation for two proportions|||Week 8||29.90|-8.48|0.274
73911699|NCT01786668|147353427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|1.123||0.427|TWO_SIDED|95.0|-3.11|1.32|||ANCOVA|||||1.32|-3.11|0.427
73911700|NCT01786668|147353427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|STANDARD_ERROR_OF_MEAN|1.13||0.039|TWO_SIDED|95.0|-4.58|-0.12|||ANCOVA|||||-0.12|-4.58|0.039
73911701|NCT01786668|147353427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74|STANDARD_ERROR_OF_MEAN|1.131||0.016|TWO_SIDED|95.0|-4.97|-0.51|||ANCOVA|||||-0.51|-4.97|0.016
73911702|NCT01786668|147353428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.517||0.05|TWO_SIDED|95.0|-5.99|0.0|||ANCOVA|||||-0.00|-5.99|0.050
73911703|NCT01786668|147353428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-8.42|-2.42|||ANCOVA|||||-2.42|-8.42|<0.001
74085427|NCT03110380|147724810|NON_INFERIORITY|It would be concluded that B/F/TAF is noninferior to DTG+F/TAF if the lower bound of the 2-sided 95.001% CI of the difference between treatment groups (B/F/TAF group -DTG+F/TAF group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|2.2|||||TWO_SIDED|95.001|-2.3|6.8|||||The differences in percentages of participants between treatment groups and their 95.001% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||6.8|-2.3|
74085428|NCT03110380|147724811|SUPERIORITY||Difference in LSM|-18.0||||0.23|TWO_SIDED|95.0|-46.0|11.0|||ANOVA|P-value, difference in least squares means (LSM), and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.||||11|-46|0.23
73911704|NCT01786668|147353428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47|STANDARD_ERROR_OF_MEAN|1.525|<|0.001|TWO_SIDED|95.0|-9.48|-3.46|||ANCOVA|||||-3.46|-9.48|<0.001
73911705|NCT01786668|147353429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.52||0.221|TWO_SIDED|95.0|-1.66|0.39|||ANCOVA|||||0.39|-1.66|0.221
73911706|NCT01786668|147353429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.83|-0.78|||ANCOVA|||||-0.78|-2.83|<0.001
73911707|NCT01786668|147353429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.523||0.001|TWO_SIDED|95.0|-2.75|-0.68|||ANCOVA|||||-0.68|-2.75|0.001
73911708|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
73911709|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
73911710|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.62|STANDARD_ERROR_OF_MEAN|7.31||0.824|TWO_SIDED|95.0|-12.71|15.95|||Normal approximation for two proportions|||Week 2||15.95|-12.71|0.824
73965084|NCT04714320|147465416|SUPERIORITY||||||=|0.809||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 57||||=0.809
73965085|NCT04714320|147465416|SUPERIORITY||||||=|0.045||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 64||||=0.045
73965086|NCT04714320|147465416|SUPERIORITY||||||=|0.104||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 64||||=0.104
74085429|NCT00693225|147724821|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
73911711|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.16|STANDARD_ERROR_OF_MEAN|8.09||0.104|TWO_SIDED|95.0|-2.69|29.01|||Normal approximation for two proportions|||Week 4||29.01|-2.69|0.104
73911712|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.01|STANDARD_ERROR_OF_MEAN|8.26||0.04|TWO_SIDED|95.0|0.81|33.2|||Normal approximation for two proportions|||Week 4||33.20|0.81|0.040
73911713|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.47|STANDARD_ERROR_OF_MEAN|7.62||0.473|TWO_SIDED|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 4||20.40|-9.46|0.473
73911714|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.4|STANDARD_ERROR_OF_MEAN|8.86||0.875|TWO_SIDED|95.0|-15.97|18.76|||Normal approximation for two proportions|||Week 8||18.76|-15.97|0.875
73911715|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8||24.97|-10.65|0.430
73911716|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.09|STANDARD_ERROR_OF_MEAN|9.15||0.32|TWO_SIDED|95.0|-8.84|27.01|||Normal approximation for two proportions|||Week 8||27.01|-8.84|0.320
73911717|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.7|STANDARD_ERROR_OF_MEAN|8.82||0.01|TWO_SIDED|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 12||39.99|5.41|0.010
73911718|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.55|STANDARD_ERROR_OF_MEAN|8.87||0.003|TWO_SIDED|95.0|9.16|43.93|||Normal approximation for two proportions|||Week 12||43.93|9.16|0.003
73911719|NCT01786668|147353430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.85|STANDARD_ERROR_OF_MEAN|8.74||0.031|TWO_SIDED|95.0|1.72|35.99|||Normal approximation for two proportions|||Week 12||35.99|1.72|0.031
73911720|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.23|STANDARD_ERROR_OF_MEAN|6.95||0.028|TWO_SIDED|95.0|1.61|28.86|||Normal approximation for two proportions|||Week 2||28.86|1.61|0.028
73911721|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 2||17.47|-6.23|0.353
73911722|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.31|STANDARD_ERROR_OF_MEAN|6.8||0.05|TWO_SIDED|95.0|-0.02|26.64|||Normal approximation for two proportions|||Week 2||26.64|-0.02|0.050
73965087|NCT04714320|147465416|SUPERIORITY||||||=|0.69||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 71||||=0.690
73965088|NCT04714320|147465416|SUPERIORITY||||||=|0.59||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 71||||=0.590
74085430|NCT03750695|147724837|OTHER||||||<|0.05|||||||Regression, Linear|||Repeated measures linear regression||||<0.05
74088356|NCT03694808|147730154|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|1.38|||||TWO_SIDED|95.0|0.88|2.15|||t-test, 2 sided|||Statistical Analysis for Year 1 (2018-2019)||2.15|0.88|
73911723|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.39|STANDARD_ERROR_OF_MEAN|6.64||0.086|TWO_SIDED|95.0|-1.62|24.39|||Normal approximation for two proportions|||Week 4||24.39|-1.62|0.086
73911724|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.93|STANDARD_ERROR_OF_MEAN|7.43||0.002|TWO_SIDED|95.0|8.37|37.48|||Normal approximation for two proportions|||Week 4||37.48|8.37|0.002
73911725|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0|STANDARD_ERROR_OF_MEAN|7.32||0.004|TWO_SIDED|95.0|6.65|35.36|||Normal approximation for two proportions|||Week 4||35.36|6.65|0.004
74026693|NCT01151137|147607017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.115||||0.046|TWO_SIDED|95.0|0.996|4.49||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||4.490|0.996|0.0460
73911726|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.35|STANDARD_ERROR_OF_MEAN|7.03||0.106|TWO_SIDED|95.0|-2.43|25.13|||Normal approximation for two proportions|||Week 8||25.13|-2.43|0.106
73911727|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.5|STANDARD_ERROR_OF_MEAN|8.02|<|0.001|TWO_SIDED|95.0|16.79|48.22|||Normal approximation for two proportions|||Week 8||48.22|16.79|<0.001
73911728|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.04|STANDARD_ERROR_OF_MEAN|7.54||0.012|TWO_SIDED|95.0|4.27|33.81|||Normal approximation for two proportions|||Week 8||33.81|4.27|0.012
73965089|NCT04714320|147465416|SUPERIORITY||||||=|0.538||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 78||||=0.538
73965090|NCT04714320|147465416|SUPERIORITY||||||=|0.407||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 78||||=0.407
73965091|NCT04714320|147465416|SUPERIORITY||||||=|0.398||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 85||||=0.398
74026694|NCT03414359|147607020|NON_INFERIORITY|As there is no existing data in the literature that clearly defines a clinically significant reduction in the onset time of anesthesia, the non-inferiority margin was defined a priori based on clinical reasoning.||||||0.1||||||The a priori threshold for statistical significance is, \<0.05|Wilcoxon (Mann-Whitney)|||To exclude a clinically important difference between the LEBF group and the chloroprocaine group, given a standard deviation of 4 minutes, and a non-inferiority margin of 3 minutes difference between groups, 62 mother-infant dyads (31 mother-infant dyads in each arm) are required to have a significance level of 5% and a power of 90%. In total, 70 female patients were recruited to account for any withdrawals.||||0.10
74026695|NCT02273973|147607024|SUPERIORITY||Difference in Response Rates|10.71||||0.049|TWO_SIDED|95.0|0.11|21.32|||Cochran-Mantel-Haenszel|||||21.32|0.11|0.0490
74026696|NCT02273973|147607025|SUPERIORITY||Difference in Response Rates|1.21||||0.3698|TWO_SIDED|95.0|-1.12|3.55|||Fisher Exact|||||3.55|-1.12|0.3698
74026697|NCT02273973|147607026|SUPERIORITY||Difference in Response Rates|18.19||||0.0332|TWO_SIDED|95.0|2.57|33.81|||Cochran-Mantel-Haenszel|||||33.81|2.57|0.0332
74085431|NCT03173560|147724852|NON_INFERIORITY|Odd ratio for ORR24W was analyzed along with 90% CI for each treatment arm using Cochran-Mantel-Haenszel (CMH) method, stratified by Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic group and prior programmed cell death protein 1/ programmed cell death protein ligand 1 (PD-1/PD-L1) treatment from IxRS data. Non-inferiority would be claimed if 1-sided P value is \<=0.045 at the final analysis for the non-inferiority test with the non-inferiority margin of the odd ratio =0.76.|Odds Ratio (OR)|0.88||||0.2676|TWO_SIDED|90.0|0.59|1.32|||Cochran-Mantel-Haenszel|||||1.32|0.59|0.2676
74026698|NCT02273973|147607027|SUPERIORITY||Difference in Response Rates|1.37||||0.4803|TWO_SIDED|95.0|-1.3|4.04|||Fisher Exact|||||4.04|-1.30|0.4803
74026699|NCT02273973|147607028|SUPERIORITY||Difference in Response Rates|5.2||||0.5017|TWO_SIDED|95.0|-9.2|19.61|||Cochran-Mantel-Haenszel|||||19.61|-9.20|0.5017
74026700|NCT02273973|147607029|SUPERIORITY||Difference in Response Rates|1.05||||1|TWO_SIDED|95.0|-2.65|4.75|||Fisher Exact|||||4.75|-2.65|1.0000
73911729|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.54|STANDARD_ERROR_OF_MEAN|7.47||0.635|TWO_SIDED|95.0|-11.1|18.19|||Normal approximation for two proportions|||Week 12||18.19|-11.10|0.635
73911730|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|34.31|STANDARD_ERROR_OF_MEAN|8.6|<|0.001|TWO_SIDED|95.0|17.45|51.18|||Normal approximation for two proportions|||Week 12||51.18|17.45|<0.001
73911731|NCT01786668|147353431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.78|STANDARD_ERROR_OF_MEAN|8.45||0.007|TWO_SIDED|95.0|6.21|39.34|||Normal approximation for two proportions|||Week 12||39.34|6.21|0.007
73965092|NCT04714320|147465416|SUPERIORITY||||||=|0.93||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 85||||=0.930
73965093|NCT04714320|147465416|SUPERIORITY||||||=|0.111||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 92||||=0.111
74026701|NCT02273973|147607030|SUPERIORITY||Difference in Response Rates|21.14||||0.0115|TWO_SIDED|95.0|5.59|36.68|||Cochran-Mantel-Haenszel|||||36.68|5.59|0.0115
74026702|NCT02273973|147607031|SUPERIORITY||Difference in Response Rates|2.66||||0.7928|TWO_SIDED|95.0|-11.88|17.2|||Cochran-Mantel-Haenszel|||||17.20|-11.88|0.7928
73911732|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.136||0.175|TWO_SIDED|95.0|-0.46|0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.08|-0.46|0.175
73911733|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.77|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||-0.24|-0.77|<0.001
73911734|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.74|-0.2|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||-0.20|-0.74|<0.001
73911735|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.141||0.003|TWO_SIDED|95.0|-0.7|-0.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.15|-0.70|0.003
73911736|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.9|-0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.34|-0.90|<0.001
73911737|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.86|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.31|-0.86|<0.001
73911738|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.158||0.026|TWO_SIDED|95.0|-0.66|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.04|-0.66|0.026
74026703|NCT02273973|147607032|SUPERIORITY||Difference in Response Rates|9.45||||0.2659|TWO_SIDED|95.0|-5.8|24.7|||Cochran-Mantel-Haenszel|||||24.70|-5.80|0.2659
73911739|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.157|<|0.001|TWO_SIDED|95.0|-0.94|-0.32|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.32|-0.94|<0.001
73911740|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.159|<|0.001|TWO_SIDED|95.0|-0.9|-0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.27|-0.90|<0.001
73911741|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.171||0.002|TWO_SIDED|95.0|-0.89|-0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.21|-0.89|0.002
73911742|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.171|<|0.001|TWO_SIDED|95.0|-1.07|-0.39|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.39|-1.07|<0.001
73911743|NCT01786668|147353432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.172|<|0.001|TWO_SIDED|95.0|-1.03|-0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.35|-1.03|<0.001
73911744|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.24|STANDARD_ERROR_OF_MEAN|7.99||0.159|TWO_SIDED|95.0|-4.41|26.89|||Normal approximation for two proportions|||Week 2||26.89|-4.41|0.159
74026704|NCT02273973|147607033|SUPERIORITY||Difference in Response Rates|7.63||||0.3299|TWO_SIDED|95.0|-6.34|21.6|||Cochran-Mantel-Haenszel|||||21.60|-6.34|0.3299
74026705|NCT02273973|147607034|SUPERIORITY||Difference in Response Rates|10.68||||0.1554|TWO_SIDED|95.0|-3.96|25.32|||Cochran-Mantel-Haenszel|||||25.32|-3.96|0.1554
73911745|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.39|STANDARD_ERROR_OF_MEAN|8.6|<|0.001|TWO_SIDED|95.0|15.54|49.24|||Normal approximation for two proportions|||Week 2||49.24|15.54|<0.001
73911746|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.7|STANDARD_ERROR_OF_MEAN|8.5||0.004|TWO_SIDED|95.0|8.04|41.36|||Normal approximation for two proportions|||Week 2||41.36|8.04|0.004
74026706|NCT02273973|147607035|SUPERIORITY||Difference in Response Rates|2.41||||0.787|TWO_SIDED|95.0|-11.82|16.63|||Cochran-Mantel-Haenszel|||||16.63|-11.82|0.7870
74026707|NCT02273973|147607036|SUPERIORITY||Ratio of Least square mean|0.83||||0.117|TWO_SIDED|95.0|0.65|1.05|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Week 3.||1.05|0.65|0.117
74026708|NCT02273973|147607036|SUPERIORITY||Ratio of Least square mean|1.25||||0.105|TWO_SIDED|95.0|0.95|1.65|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Surgery.||1.65|0.95|0.105
74026709|NCT02273973|147607038|SUPERIORITY||Least squares mean difference|-13.32||||0.002|TWO_SIDED|95.0|-21.67|-4.96|||Regression, Linear|||||-4.96|-21.67|0.002
74026710|NCT01282814|147607044|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|115.85|||||TWO_SIDED|90.0|108.45|123.72|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||123.72|108.45|
74085432|NCT03173560|147724853|SUPERIORITY|Percentage of participants with intolerable Grade 2 or any Grade \>=Grade 3 TEAEs within 24 weeks was tested using CMH method at 2-sided α=0.05, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment from IxRS data. The treatment difference and 95% CI were also calculated based on asymptotic normal approximation.|Difference|3.2||||0.4763|TWO_SIDED|95.0|-5.5|11.9|||Cochran-Mantel-Haenszel|||||11.9|-5.5|0.4763
73911747|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.7|STANDARD_ERROR_OF_MEAN|8.82||0.01|TWO_SIDED|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 4||39.99|5.41|0.010
73911748|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|38.08|STANDARD_ERROR_OF_MEAN|8.82|<|0.001|TWO_SIDED|95.0|20.79|55.38|||Normal approximation for two proportions|||Week 4||55.38|20.79|<0.001
73911749|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.32|STANDARD_ERROR_OF_MEAN|8.88|<|0.001|TWO_SIDED|95.0|14.9|49.73|||Normal approximation for two proportions|||Week 4||49.73|14.90|<0.001
73911750|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.82|STANDARD_ERROR_OF_MEAN|9.39||0.114|TWO_SIDED|95.0|-3.58|33.22|||Normal approximation for two proportions|||Week 8||33.22|-3.58|0.114
73911751|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.2|STANDARD_ERROR_OF_MEAN|9.33||0.001|TWO_SIDED|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8||48.49|11.92|0.001
73911752|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.2|STANDARD_ERROR_OF_MEAN|9.33||0.001|TWO_SIDED|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8||48.49|11.92|0.001
73911753|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.47|STANDARD_ERROR_OF_MEAN|9.33||0.009|TWO_SIDED|95.0|6.18|42.76|||Normal approximation for two proportions|||Week 12||42.76|6.18|0.009
73911754|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.01|STANDARD_ERROR_OF_MEAN|9.15|<|0.001|TWO_SIDED|95.0|18.09|53.94|||Normal approximation for two proportions|||Week 12||53.94|18.09|<0.001
73911755|NCT01786668|147353433|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.32|STANDARD_ERROR_OF_MEAN|9.3||0.002|TWO_SIDED|95.0|10.09|46.55|||Normal approximation for two proportions|||Week 12||46.55|10.09|0.002
73911756|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
73911757|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
73911758|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
73911759|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.66|STANDARD_ERROR_OF_MEAN|5.52||0.306|TWO_SIDED|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4||16.48|-5.17|0.306
74085433|NCT03173560|147724854|OTHER|The hazard ratio and the corresponding 90% CIs were estimated using the Cox regression model with Efron's method for ties, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment.|Hazard Ratio (HR)|1.42|||||TWO_SIDED|90.0|1.08|1.86||||||||1.86|1.08|
74085434|NCT03173560|147724855|OTHER|Odd ratio for ORR was analyzed along with 90% CI for each treatment arm using CMH method stratified by MSKCC prognostic group and PD-1/PD-L1 treatment from IxRS data.|Odds Ratio (OR)|0.77|||||TWO_SIDED|90.0|0.52|1.14||||||||1.14|0.52|
74088357|NCT03694808|147730154|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.86|||||TWO_SIDED|95.0|0.53|1.4|||t-test, 2 sided|||Statistical Analysis for Year 2 (2019-2020)||1.4|0.53|
73911760|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.66|STANDARD_ERROR_OF_MEAN|5.52||0.306|TWO_SIDED|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4||16.48|-5.17|0.306
73911761|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.5|STANDARD_ERROR_OF_MEAN|5.99||0.113|TWO_SIDED|95.0|-2.24|21.24|||Normal approximation for two proportions|||Week 4||21.24|-2.24|0.113
73911762|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.73|STANDARD_ERROR_OF_MEAN|6.08||0.775|TWO_SIDED|95.0|-10.18|13.65|||Normal approximation for two proportions|||Week 8||13.65|-10.18|0.775
73911763|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.12|STANDARD_ERROR_OF_MEAN|7.43||0.021|TWO_SIDED|95.0|2.56|31.68|||Normal approximation for two proportions|||Week 8||31.68|2.56|0.021
73911764|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.27|STANDARD_ERROR_OF_MEAN|7.17||0.064|TWO_SIDED|95.0|-0.79|27.34|||Normal approximation for two proportions|||Week 8||27.34|-0.79|0.064
73911765|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.47|STANDARD_ERROR_OF_MEAN|7.09||0.292|TWO_SIDED|95.0|-6.42|21.36|||Normal approximation for two proportions|||Week 12||21.36|-6.42|0.292
73911766|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.31|STANDARD_ERROR_OF_MEAN|7.38||0.125|TWO_SIDED|95.0|-3.16|25.78|||Normal approximation for two proportions|||Week 12||25.78|-3.16|0.125
73911767|NCT01786668|147353434|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.24|STANDARD_ERROR_OF_MEAN|7.51||0.078|TWO_SIDED|95.0|-1.49|27.96|||Normal approximation for two proportions|||Week 12||27.96|-1.49|0.078
73911768|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
73911769|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
73911770|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
73911771|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|2.72||0.989|TWO_SIDED|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 4||5.29|-5.37|0.989
73911772|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.81|STANDARD_ERROR_OF_MEAN|3.77||0.313|TWO_SIDED|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 4||11.20|-3.58|0.313
73911773|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 4||13.91|-2.45|0.170
73911774|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.81|STANDARD_ERROR_OF_MEAN|3.77||0.313|TWO_SIDED|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 8||11.20|-3.58|0.313
73911775|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|2.72||0.989|TWO_SIDED|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 8||5.29|-5.37|0.989
74026711|NCT01282814|147607045|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.97|||||TWO_SIDED|90.0|103.68|116.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||116.63|103.68|
73911776|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.65|STANDARD_ERROR_OF_MEAN|4.53||0.091|TWO_SIDED|95.0|-1.22|16.52|||Normal approximation for two proportions|||Week 8||16.52|-1.22|0.091
73911777|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12||17.47|-6.23|0.353
73911778|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12||17.47|-6.23|0.353
73911779|NCT01786668|147353435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.54|STANDARD_ERROR_OF_MEAN|6.26||0.228|TWO_SIDED|95.0|-4.73|19.81|||Normal approximation for two proportions|||Week 12||19.81|-4.73|0.228
73911780|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.31||0.926|TWO_SIDED|95.0|-0.64|0.58|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.58|-0.64|0.926
73911781|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.308||0.718|TWO_SIDED|95.0|-0.72|0.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.50|-0.72|0.718
73911782|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.31||0.57|TWO_SIDED|95.0|-0.43|0.79|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.79|-0.43|0.570
73911783|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.343||0.384|TWO_SIDED|95.0|-0.97|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.38|-0.97|0.384
74085435|NCT04254809|147724876|SUPERIORITY||Slope|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-1.02|-0.25||Threshold for statistical significance was p = .05|Regression, Linear||REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regressing scores at one-week follow-up onto scores at baseline.||-0.25|-1.02|.001
73911784|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.341||0.334|TWO_SIDED|95.0|-1.0|0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.34|-1.00|0.334
73911785|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.343||0.474|TWO_SIDED|95.0|-0.92|0.43|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.43|-0.92|0.474
73911786|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.381||0.445|TWO_SIDED|95.0|-1.04|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.46|-1.04|0.445
73911787|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.38||0.174|TWO_SIDED|95.0|-1.27|0.23|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.23|-1.27|0.174
73911788|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.383||0.217|TWO_SIDED|95.0|-1.23|0.28|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.28|-1.23|0.217
73911789|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.396||0.024|TWO_SIDED|95.0|-1.69|-0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.12|-1.69|0.024
73911790|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.396||0.01|TWO_SIDED|95.0|-1.81|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.24|-1.81|0.010
73911791|NCT01786668|147353436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.399||0.038|TWO_SIDED|95.0|-1.62|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.04|-1.62|0.038
73911792|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.15|STANDARD_ERROR_OF_MEAN|6.75||0.539|TWO_SIDED|95.0|-17.38|9.08|||Normal approximation for two proportions|||Week 2||9.08|-17.38|0.539
73911793|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.47|STANDARD_ERROR_OF_MEAN|7.62||0.473|TWO_SIDED|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 2||20.40|-9.46|0.473
73911794|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
73911795|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.52||0.393|TWO_SIDED|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4||23.98|-9.43|0.393
73911796|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.51|STANDARD_ERROR_OF_MEAN|8.2||0.854|TWO_SIDED|95.0|-14.57|17.59|||Normal approximation for two proportions|||Week 4||17.59|-14.57|0.854
73911797|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.52||0.393|TWO_SIDED|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4||23.98|-9.43|0.393
73911798|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8||24.97|-10.65|0.430
73911799|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.24|STANDARD_ERROR_OF_MEAN|9.02||0.561|TWO_SIDED|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 8||22.92|-12.44|0.561
73911800|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.93|STANDARD_ERROR_OF_MEAN|9.24||0.162|TWO_SIDED|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 8||31.04|-5.17|0.162
73911801|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.62|STANDARD_ERROR_OF_MEAN|9.11||0.013|TWO_SIDED|95.0|4.76|40.49|||Normal approximation for two proportions|||Week 12||40.49|4.76|0.013
73911802|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.78|STANDARD_ERROR_OF_MEAN|9.07||0.038|TWO_SIDED|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12||36.55|1.01|0.038
73911803|NCT01786668|147353437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.78|STANDARD_ERROR_OF_MEAN|9.07||0.038|TWO_SIDED|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12||36.55|1.01|0.038
73911804|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.272||0.164|TWO_SIDED|95.0|-0.92|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.16|-0.92|0.164
73911805|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.271||0.129|TWO_SIDED|95.0|-0.95|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.12|-0.95|0.129
73911806|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.272||0.66|TWO_SIDED|95.0|-0.66|0.42|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.42|-0.66|0.660
73911807|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.297||0.256|TWO_SIDED|95.0|-0.92|0.25|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.25|-0.92|0.256
73911808|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.296||0.048|TWO_SIDED|95.0|-1.17|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.00|-1.17|0.048
73911809|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.297||0.318|TWO_SIDED|95.0|-0.88|0.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.29|-0.88|0.318
74088358|NCT03694808|147730155|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|1.85|||||TWO_SIDED|95.0|1.23|2.79|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||2.79|1.23|
73911810|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.35||0.522|TWO_SIDED|95.0|-0.92|0.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.47|-0.92|0.522
73911811|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.35||0.05|TWO_SIDED|95.0|-1.38|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.00|-1.38|0.050
73911812|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.352||0.337|TWO_SIDED|95.0|-1.03|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.36|-1.03|0.337
73911813|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.373||0.214|TWO_SIDED|95.0|-1.2|0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.27|-1.20|0.214
73911814|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.372||0.011|TWO_SIDED|95.0|-1.69|-0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.22|-1.69|0.011
73911815|NCT01786668|147353438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.375||0.031|TWO_SIDED|95.0|-1.55|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.08|-1.55|0.031
73911816|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.106||0.982|TWO_SIDED|95.0|-0.21|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.21|-0.21|0.982
73911817|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.106||0.151|TWO_SIDED|95.0|-0.36|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.06|-0.36|0.151
73911818|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.106||0.205|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.07|-0.34|0.205
73911819|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.118||0.898|TWO_SIDED|95.0|-0.25|0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.22|-0.25|0.898
73911820|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.118||0.37|TWO_SIDED|95.0|-0.34|0.13|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.13|-0.34|0.370
73911821|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.119||0.288|TWO_SIDED|95.0|-0.36|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.11|-0.36|0.288
73911822|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.242|TWO_SIDED|95.0|-0.42|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.11|-0.42|0.242
73911823|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.135||0.12|TWO_SIDED|95.0|-0.48|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.06|-0.48|0.120
73911824|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.136||0.031|TWO_SIDED|95.0|-0.56|-0.03|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.03|-0.56|0.031
73911825|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.157||0.28|TWO_SIDED|95.0|-0.48|0.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.14|-0.48|0.280
73911826|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.157||0.099|TWO_SIDED|95.0|-0.57|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.05|-0.57|0.099
73911827|NCT01786668|147353439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.158||0.014|TWO_SIDED|95.0|-0.7|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.08|-0.70|0.014
73911828|NCT01786668|147353440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.387||0.895|TWO_SIDED|95.0|-0.81|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.71|-0.81|0.895
73911829|NCT01786668|147353440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.386||0.033|TWO_SIDED|95.0|-1.59|-0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.07|-1.59|0.033
73911830|NCT01786668|147353440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.388||0.044|TWO_SIDED|95.0|-1.55|-0.02|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.02|-1.55|0.044
73911831|NCT01786668|147353440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.411||0.53|TWO_SIDED|95.0|-1.07|0.55|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.55|-1.07|0.530
73911832|NCT01786668|147353440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.411||0.114|TWO_SIDED|95.0|-1.46|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.16|-1.46|0.114
74085436|NCT04254809|147724877|SUPERIORITY||Slope|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.99|-0.23||Threshold for significance was p = .05|Regression, Linear||REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-month follow-up onto scores at baseline.||-0.23|-0.99|.002
73911833|NCT01786668|147353440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.415||0.297|TWO_SIDED|95.0|-1.25|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.38|-1.25|0.297
73911834|NCT01786668|147353440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.37||0.377|TWO_SIDED|95.0|-1.06|0.4|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.40|-1.06|0.377
73911835|NCT01786668|147353440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.37||0.006|TWO_SIDED|95.0|-1.77|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.31|-1.77|0.006
73911836|NCT01786668|147353440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.373||0.017|TWO_SIDED|95.0|-1.64|-0.17|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.17|-1.64|0.017
73911837|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.414||0.8|TWO_SIDED|95.0|-0.92|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.71|-0.92|0.800
73911838|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.413||0.113|TWO_SIDED|95.0|-0.16|1.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||1.47|-0.16|0.113
73911839|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.414||0.064|TWO_SIDED|95.0|-1.59|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.05|-1.59|0.064
73911840|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.368||0.972|TWO_SIDED|95.0|-0.74|0.71|||Mixed Models Analysis|||Week 4||0.71|-0.74|0.972
73911841|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.368||0.44|TWO_SIDED|95.0|-0.44|1.01|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||1.01|-0.44|0.440
73911842|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.369||0.311|TWO_SIDED|95.0|-1.1|0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.35|-1.10|0.311
73911843|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.629||0.501|TWO_SIDED|95.0|-1.66|0.82|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.82|-1.66|0.501
73911844|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.629||0.543|TWO_SIDED|95.0|-1.63|0.86|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.86|-1.63|0.543
74026712|NCT01282814|147607046|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.46|||||TWO_SIDED|90.0|101.45|111.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.71|101.45|
74088359|NCT03694808|147730155|NON_INFERIORITY|2-sided t-test performed on log-transformed titers; estimate and 95% confidence interval of log-scale difference exponentiated to generate GMT ratio and its 95% CI below.|Ratio of GMT (Fluzone/Fluad)|0.88|||||TWO_SIDED|95.0|0.61|1.26|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||1.26|0.61|
73911845|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.636||0.287|TWO_SIDED|95.0|-1.93|0.57|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.57|-1.93|0.287
73911846|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.519||0.82|TWO_SIDED|95.0|-0.91|1.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||1.14|-0.91|0.820
73911847|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.52||0.711|TWO_SIDED|95.0|-0.83|1.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||1.22|-0.83|0.711
73911848|NCT01786668|147353442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.524||0.424|TWO_SIDED|95.0|-1.45|0.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.61|-1.45|0.424
73911849|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.203||0.785|TWO_SIDED|95.0|-0.34|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.46|-0.34|0.785
73911850|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.203||0.605|TWO_SIDED|95.0|-0.3|0.51|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.51|-0.30|0.605
73911851|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.204||0.175|TWO_SIDED|95.0|-0.68|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.12|-0.68|0.175
73911852|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.232||0.482|TWO_SIDED|95.0|-0.29|0.62|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.62|-0.29|0.482
73911853|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.231||0.288|TWO_SIDED|95.0|-0.7|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.21|-0.70|0.288
73911854|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.233||0.278|TWO_SIDED|95.0|-0.71|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.21|-0.71|0.278
73911855|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.254||0.134|TWO_SIDED|95.0|-0.12|0.88|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.88|-0.12|0.134
73965094|NCT04714320|147465416|SUPERIORITY||||||=|0.196||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 92||||=0.196
73965095|NCT04714320|147465416|SUPERIORITY||||||=|0.816||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 106||||=0.816
74085437|NCT04254809|147724878|SUPERIORITY||Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.86|-0.05||Threshold for statistical significance was p = .05|Regression, Linear||REST coded as -, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL.|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-week follow-up onto scores at baseline.||-.05|-0.86|.03
74085438|NCT04480307|147724880|SUPERIORITY||LS Mean Difference|-0.031||||0.5084|TWO_SIDED|95.0|-0.124|0.063|||ANCOVA|||||0.063|-0.124|0.5084
74085439|NCT04480307|147724880|SUPERIORITY||Difference of change from Baseline|-0.021|||||TWO_SIDED|95.0|-0.121|0.057|||Bayesian|Difference of change from baseline a posteriori||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.057|-0.121|
73965096|NCT04714320|147465416|SUPERIORITY||||||=|0.473||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 106||||=0.473
74085440|NCT04480307|147724881|SUPERIORITY||LS Mean Difference|-0.002||||0.9472|TWO_SIDED|95.0|-0.052|0.049|||ANCOVA|||||0.049|-0.052|0.9472
74085441|NCT04480307|147724881|SUPERIORITY||Difference of change from Baseline|0.012|||||TWO_SIDED|95.0|-0.036|0.059|||Bayesian|Difference of change from Baseline a posteriori.||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.059|-0.036|
74085442|NCT04480307|147724882|SUPERIORITY||LS Mean Difference|0.154||||0.4027|TWO_SIDED|95.0|-0.216|0.524|||ANCOVA|||ANCOVA analysis for T1 lesion volume parameter||0.524|-0.216|0.4027
73858205|NCT00303446|147261886|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.11
74085443|NCT04480307|147724882|SUPERIORITY||LS Mean Difference|0.01||||0.7428|TWO_SIDED|95.0|-0.051|0.071|||ANCOVA|||ANCOVA analysis for T2 lesion volume parameter||0.071|-0.051|0.7428
74085444|NCT04480307|147724883|SUPERIORITY||LS Mean Difference|0.003||||0.7314|TWO_SIDED|95.0|-0.013|0.018|||ANCOVA|||||0.018|-0.013|0.7314
73858206|NCT00303446|147261887|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.08
73858207|NCT00303446|147261888|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.73
73858208|NCT00303446|147261889|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.37
73858209|NCT00303446|147261890|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.65
73858210|NCT00303446|147261891|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.99
73858211|NCT00303446|147261892|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||1.0
73858212|NCT00303446|147261893|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.014
73858213|NCT00303446|147261894|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Generalized estimating equation model showed a significant interaction between time and treatment; therefore a two sample t-test was used at each time point. P-value is given for comparison at 24 months.|t-test, 2 sided|||||||0.033
73858214|NCT00303446|147261895|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.61
73858215|NCT00642174|147261912|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Net)|61.6|||<|0.0001||95.0|53.83|69.31||P-value is for 4 Hours After Loading Dose.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (i.e. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there is no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 4 hours after administration of loading dose. Assuming 90% power, 2-sided alpha of 0.05, and a 17.5% difference in IPA between treatment groups with a standard deviation of 20, a total of 15 completed subjects per sequence group (i.e., 15 subject who receive prasugrel first, then clopidogrel; and 15 subjects who receive clopidogrel first, then prasugrel) was determined.||69.31|53.83|<0.0001
73858216|NCT00642174|147261913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.5|||<|0.0001||95.0|27.43|45.52||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 1 hour after administration of the loading dose.||45.52|27.43|<0.0001
73858217|NCT00642174|147261913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.9|||<|0.0001||95.0|49.56|66.19||P-value for 24 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours after administration of the loading dose.||66.19|49.56|<0.0001
74085445|NCT04480307|147724883|SUPERIORITY||Difference of change from Baseline|0.005|||||TWO_SIDED|95.0|-0.01|0.023|||Bayesian|Difference of change from Baseline a posteriori||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.023|-0.010|
74085446|NCT04480307|147724884|SUPERIORITY||LS Mean Difference|0.0||||0.7662|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|||||0|0|0.7662
73911856|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.254||0.397|TWO_SIDED|95.0|-0.29|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.72|-0.29|0.397
73911857|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.257||0.964|TWO_SIDED|95.0|-0.5|0.52|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.52|-0.50|0.964
73911858|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.269||0.155|TWO_SIDED|95.0|-0.15|0.91|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.91|-0.15|0.155
73911859|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.269||0.491|TWO_SIDED|95.0|-0.34|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.72|-0.34|0.491
73911860|NCT01786668|147353443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.271||0.515|TWO_SIDED|95.0|-0.71|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.36|-0.71|0.515
73911861|NCT01786668|147353444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|1.312||0.006|TWO_SIDED|95.0|1.06|6.24|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.24|1.06|0.006
73965097|NCT04714320|147465416|SUPERIORITY||||||=|0.615||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 120||||=0.615
74085447|NCT02795676|147724893|NON_INFERIORITY|Non-inferiority was to be declared if the lower bound of the confidence interval for the treatment difference is above the non-inferiority margin, which was met. No p-value was calculated as this is not relevant for non-inferiority.|Median Difference (Final Values)|-0.359|||||TWO_SIDED|95.0|-2.444|1.726|||Regression, Linear|The primary efficacy analysis compared eGFR slope between the treatment arms using a 2-stage model with quantile regression.||||1.726|-2.444|
73911862|NCT01786668|147353444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|1.305||0.004|TWO_SIDED|95.0|1.23|6.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.37|1.23|0.004
73911863|NCT01786668|147353444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|STANDARD_ERROR_OF_MEAN|1.328||0.001|TWO_SIDED|95.0|1.74|6.98|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.98|1.74|0.001
73911864|NCT01786668|147353444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|1.857||0.857|TWO_SIDED|95.0|-4.0|3.33|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||3.33|-4.00|0.857
73911865|NCT01786668|147353444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|1.848||0.35|TWO_SIDED|95.0|-1.91|5.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||5.37|-1.91|0.350
73911866|NCT01786668|147353444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.876||0.49|TWO_SIDED|95.0|-2.4|5.0|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||5.00|-2.40|0.490
73911867|NCT01786668|147353445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.048||0.125|TWO_SIDED|95.0|-0.02|0.17|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.17|-0.02|0.125
73911868|NCT01786668|147353445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.048||0.207|TWO_SIDED|95.0|-0.03|0.16|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.16|-0.03|0.207
73965098|NCT04714320|147465416|SUPERIORITY||||||=|0.214||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 120||||=0.214
74085448|NCT02690935|147724917|SUPERIORITY|||||||0.642||||||No adjustment of the p-value|t-test, 2 sided|||H0: The efficacy of 2LALERG and placebo are similar H1: The efficacy of 2LALERG and placebo are different||||0.642
73911869|NCT01786668|147353445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.049||0.013|TWO_SIDED|95.0|0.03|0.22|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.22|0.03|0.013
73911870|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72|STANDARD_ERROR_OF_MEAN|1.232||0.163|TWO_SIDED|95.0|-0.71|4.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||4.15|-0.71|0.163
73911871|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|1.232||0.955|TWO_SIDED|95.0|-2.36|2.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||2.50|-2.36|0.955
73911872|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|1.237||0.826|TWO_SIDED|95.0|-2.17|2.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||2.71|-2.17|0.826
73911873|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|1.322||0.246|TWO_SIDED|95.0|-1.07|4.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||4.14|-1.07|0.246
73911874|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.318||0.467|TWO_SIDED|95.0|-1.64|3.56|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||3.56|-1.64|0.467
73911875|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|1.328||0.948|TWO_SIDED|95.0|-2.53|2.7|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||2.70|-2.53|0.948
73911876|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|1.479||0.255|TWO_SIDED|95.0|-1.23|4.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.61|-1.23|0.255
73965099|NCT04714320|147465416|SUPERIORITY||||||=|0.575||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 148||||=0.575
73965100|NCT04714320|147465416|SUPERIORITY||||||=|0.276||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 148||||=0.276
73965101|NCT04714320|147465416|SUPERIORITY||||||=|0.573||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 169||||=0.573
73965102|NCT04714320|147465416|SUPERIORITY||||||=|0.706||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 169||||=0.706
73911877|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|1.479||0.187|TWO_SIDED|95.0|-0.96|4.87|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.87|-0.96|0.187
73911878|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|1.497||0.373|TWO_SIDED|95.0|-1.62|4.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.29|-1.62|0.373
73965103|NCT04714320|147465417|SUPERIORITY||||||=|0.853||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 8||||=0.853
73965104|NCT04714320|147465417|SUPERIORITY||||||=|0.542||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.542
73965105|NCT04714320|147465417|SUPERIORITY||||||=|0.43||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.430
73965106|NCT04714320|147465417|SUPERIORITY||||||=|0.587||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.587
73965107|NCT04714320|147465417|SUPERIORITY||||||=|0.91||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.910
73965108|NCT04714320|147465417|SUPERIORITY||||||=|0.846||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.846
73965109|NCT04714320|147465417|SUPERIORITY|||||||0.634||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||0.634
73965110|NCT04714320|147465417|SUPERIORITY||||||=|0.767||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.767
73965111|NCT04714320|147465417|SUPERIORITY||||||=|0.399||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.399
73965112|NCT04714320|147465417|SUPERIORITY||||||=|0.323||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.323
73965113|NCT04714320|147465417|SUPERIORITY||||||=|0.115||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.115
73965114|NCT04714320|147465417|SUPERIORITY||||||=|0.982||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.982
73911879|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|1.643||0.313|TWO_SIDED|95.0|-1.58|4.9|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||4.90|-1.58|0.313
73911880|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|1.642||0.017|TWO_SIDED|95.0|0.71|7.19|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||7.19|0.71|0.017
73911881|NCT01786668|147353446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.51|STANDARD_ERROR_OF_MEAN|1.66||0.007|TWO_SIDED|95.0|1.23|7.78|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||7.78|1.23|0.007
73911882|NCT03570697|147353447|SUPERIORITY||Treatment difference|21.2|STANDARD_ERROR_OF_MEAN|7.9||0.015|TWO_SIDED|95.0|4.7|37.7|||ANCOVA|||||37.7|4.7|0.015
73911883|NCT03570697|147353448|SUPERIORITY||Treatment difference|37.47|STANDARD_ERROR_OF_MEAN|17.04||0.041|TWO_SIDED|95.0|1.63|73.31|||ANCOVA|||||73.31|1.63|0.041
73911884|NCT03570697|147353449|SUPERIORITY||Treatment difference|32.51|STANDARD_ERROR_OF_MEAN|9.52||0.003|TWO_SIDED|95.0|12.67|52.35|||ANCOVA|||||52.35|12.67|0.003
73911885|NCT03570697|147353450|SUPERIORITY||Treatment difference|-26.0|STANDARD_ERROR_OF_MEAN|11.4||0.032|TWO_SIDED|95.0|-49.6|-2.4|||ANCOVA|||||-2.4|-49.6|0.032
73965115|NCT04714320|147465417|SUPERIORITY||||||=|0.859||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.859
73965116|NCT04714320|147465417|SUPERIORITY||||||=|0.344||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.344
73965117|NCT04714320|147465417|SUPERIORITY||||||=|0.633||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.633
73911886|NCT03570697|147353451|SUPERIORITY||Treatment difference|16.0|STANDARD_ERROR_OF_MEAN|7.5||0.036|TWO_SIDED|95.0|1.1|31.0|||ANCOVA|||||31.0|1.1|0.036
73911887|NCT03570697|147353452|SUPERIORITY||Treatment difference|-30.0|STANDARD_ERROR_OF_MEAN|10.4||0.005|TWO_SIDED|95.0|-50.5|-9.5|||ANCOVA|||||-9.5|-50.5|0.005
73965118|NCT04714320|147465417|SUPERIORITY||||||=|0.889||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.889
73965119|NCT04714320|147465417|SUPERIORITY||||||=|0.241||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.241
73911888|NCT03570697|147353453|SUPERIORITY||Treatment difference|-2.43|STANDARD_ERROR_OF_MEAN|0.81||0.003|TWO_SIDED|95.0|-4.04|-0.82|||ANCOVA|||||-0.82|-4.04|0.003
73911889|NCT01776840|147353454|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.011|TWO_SIDED|95.0|0.59|0.96|||Log Rank|||||0.96|0.59|0.011
73911890|NCT03068455|147353493|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.78|1.04|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab|||1.04|0.78|
73911891|NCT03068455|147353494|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.75|1.14|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab|||1.14|0.75|
73911892|NCT03068455|147353495|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.8|1.32|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.32|0.80|
73911893|NCT03068455|147353496|SUPERIORITY||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|0.85|1.73|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.73|0.85|
73911894|NCT03068455|147353497|SUPERIORITY|\< 1% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.73|1.14|||||Unstratisfied HR, Nivolumab over Ipilimumab|||1.14|0.73|
73911895|NCT03068455|147353497|SUPERIORITY|\>= 1% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.18|0.76|
73911896|NCT03068455|147353497|SUPERIORITY|\>= 5% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.71|1.34|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.34|0.71|
73911897|NCT03068455|147353497|SUPERIORITY|\< 5% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.1|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.10|0.77|
73911898|NCT03068455|147353497|SUPERIORITY|Non-quantifiable Tumor PD-L1 Expression|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.38|1.51|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.51|0.38|
73911899|NCT02498132|147353527|OTHER|A generalized estimating equation (GEE) model assuming a normal distribution, identity link function, and exchangeable correlation matrix was used to examine the interaction between time and treatment condition on BDI-II depressive symptoms adjusting for the main effects of baseline depressive symptoms, time, and treatment condition.|||||<|0.05|||||||Chi-squared|||||||<.05
73965120|NCT04714320|147465417|SUPERIORITY||||||=|0.367||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.367
73965121|NCT04714320|147465417|SUPERIORITY||||||=|0.716||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.716
73911900|NCT02653872|147353556|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of Cmax for AZD7986 administered with verapamil over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|153.4|||||TWO_SIDED|90.0|136.16|172.83|||ANOVA|||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.||172.83|136.16|
73911901|NCT02653872|147353556|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of Cmax for AZD7986 administered with itraconazole over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|60.66|||||TWO_SIDED|90.0|53.84|68.34|||ANOVA|||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.||68.34|53.84|
73911902|NCT02653872|147353557|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC for AZD7986 administered with verapamil over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|132.25|||||TWO_SIDED|90.0|121.78|143.64|||ANOVA|||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.||143.64|121.78|
73911903|NCT02653872|147353557|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC for AZD7986 administered with itraconazole over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|113.7|||||TWO_SIDED|90.0|104.69|123.49|||ANOVA|||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.||123.49|104.69|
73911904|NCT02653872|147353558|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC (0-t) for AZD7986 administered with verapamil over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|133.51|||||TWO_SIDED|90.0|122.7|145.29|||ANOVA|||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.||145.29|122.70|
73911905|NCT02653872|147353558|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC (0-t) for AZD7986 administered with itraconazole over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|112.45|||||TWO_SIDED|90.0|103.34|122.37|||ANOVA|||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.||122.37|103.34|
73911906|NCT00578383|147353593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.11|STANDARD_ERROR_OF_MEAN|1.17||0.009|TWO_SIDED|95.0|0.5|5.8||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.||5.8|0.5|0.009
73911907|NCT00578383|147353594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.06|STANDARD_ERROR_OF_MEAN|0.38||0.006|TWO_SIDED|95.0|0.2|1.9||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by a visual analog scale.||1.9|0.2|0.006
73911908|NCT00578383|147353595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|1.24||0.001|TWO_SIDED|95.0|1.3|6.9||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (POSITIVE SCALE).||6.9|1.3|0.001
73911909|NCT00578383|147353596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.39||0.15|TWO_SIDED|95.0|-1.1|5.1||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (negative scale)||5.1|-1.1|0.15
73911910|NCT00578383|147353597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.47||0.09|TWO_SIDED|95.0|-1.2|6.2||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the 17-item Hamilton Depression Rating Scale.||6.2|-1.2|0.09
73965122|NCT04714320|147465417|SUPERIORITY||||||=|0.21||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.210
74085449|NCT02690935|147724918|SUPERIORITY|||||||0.829||||||No adjustment for multiplicity|t-test, 2 sided|||H0: 2LALERG and placebo have the same effect on the quality of life H1: 2LALERG and placebo do not have the same effect on the quality of life||||0.829
74085450|NCT01263561|147724959|NON_INFERIORITY_OR_EQUIVALENCE|A sample size calculation determined that 52 eyes were required to detect a 2.0 mmHg IOP difference with a power of 80%.||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||.85
73911911|NCT00578383|147353598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|2.11||0.19|TWO_SIDED|95.0|-3.3|9.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.||9.6|-3.3|0.19
73911912|NCT00578383|147353599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|0.51||0.15|TWO_SIDED|95.0|-0.6|2.1||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by a visual analog scale.||2.1|-0.6|0.15
73911913|NCT00578383|147353600|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.58|STANDARD_ERROR_OF_MEAN|0.67||0.04|TWO_SIDED|95.0|-0.4|3.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by a visual analog scale.||3.6|-0.4|0.04
73911914|NCT00578383|147353601|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|1.67||0.004|TWO_SIDED|95.0|0.8|9.2||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (positive scale)||9.2|0.8|0.004
73911915|NCT00578383|147353602|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.58||0.3|TWO_SIDED|95.0|1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (positive scale)||5.8|1.3|0.30
74085451|NCT01263561|147724960|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation only for main outcome measure of IOP.||||||0.24|TWO_SIDED||||||Kaplan Meier|||||||.24
73911916|NCT00578383|147353603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.01||0.52|TWO_SIDED|95.0|-4.1|6.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (negative scale)||6.8|-4.1|0.52
73911917|NCT00578383|147353604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.43||0.1||95.0|-1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (negative scale)||5.8|-1.3|0.10
73911918|NCT04092582|147353636|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6835|TWO_SIDED|95.0|0.55|1.47|||Regression, Cox|||||1.47|0.55|0.6835
73911919|NCT04092582|147353637|SUPERIORITY||Rate Ratio|1.0989||||0.7648|TWO_SIDED|95.0|0.5925|2.0381|||Poisson regression|||||2.0381|0.5925|0.7648
73911920|NCT04092582|147353638|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.5248|TWO_SIDED|95.0|0.43|1.54|||Regression, Cox|||||1.54|0.43|0.5248
73911921|NCT04092582|147353639|SUPERIORITY|||||||0.125|||||||Mixed model for repeated measures (MMRM)|||||||0.1250
73911922|NCT04092582|147353640|SUPERIORITY|||||||0.2249|||||||Mixed model for repeated measures (MMRM)|||||||0.2249
73911923|NCT04092582|147353641|SUPERIORITY|||||||0.9693|||||||Mixed model for repeated measures (MMRM)|||||||0.9693
73911924|NCT04092582|147353642|SUPERIORITY|||||||0.9855|||||||Mixed model for repeated measures (MMRM)|||||||0.9855
73965123|NCT04714320|147465417|SUPERIORITY||||||=|0.363||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.363
73965124|NCT04714320|147465417|SUPERIORITY||||||=|0.193||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.193
73965125|NCT04714320|147465417|SUPERIORITY||||||=|0.135||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.135
74085452|NCT01263561|147724961|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation only performed for main outcome measure of IOP.||||||0.8|TWO_SIDED|||||Above p is for number of subjects with any complication. P values above 0.05 are considered statistically insignificant in this study.|Chi-squared|||||||0.80
73911925|NCT02195583|147353728|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Calculated from Analysis of Variance (ANOVA) model using treatment and study period as fixed factors and participant as random effect.||Linear contrasts were fitted in order to establish whether there was a dose-response relationship. Linear contrasts were for experimental dentifrice: non-zinc treatments.||||<0.0001
73911926|NCT02195583|147353728|SUPERIORITY_OR_OTHER|||||||0.2274||95.0|||||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.||Quadratic contrasts were fitted in order to establish whether there was a dose-response relationship. Quadratic contrasts are for experimental dentifrice: non-zinc treatments.||||0.2274
73911927|NCT02195583|147353728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68||||0.595|TWO_SIDED|95.0|-1.84|3.2|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (1150 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||3.20|-1.84|0.5950
73911928|NCT02195583|147353728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.93||||0.0002|TWO_SIDED|95.0|2.38|7.48|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||7.48|2.38|0.0002
73911929|NCT02195583|147353728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.25||||0.0013|TWO_SIDED|95.0|1.68|6.82|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).|||6.82|1.68|0.0013
73911930|NCT02195583|147353728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.71|||<|0.0001|TWO_SIDED|95.0|5.2|10.21|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||10.21|5.20|<0.0001
73911931|NCT02195583|147353728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.03|||<|0.0001|TWO_SIDED|95.0|4.51|9.55|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).|||9.55|4.51|<0.0001
73911932|NCT02195583|147353728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78||||0.0325|TWO_SIDED|95.0|0.23|5.32|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (250 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (250 ppm).|||5.32|0.23|0.0325
73911933|NCT02195583|147353728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16||||0.092|TWO_SIDED|95.0|-4.67|0.35|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base A' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base A'.|||0.35|-4.67|0.0920
73911934|NCT02195583|147353728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56||||0.2185|TWO_SIDED|95.0|-4.04|0.93|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base B' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base B'.|||0.93|-4.04|0.2185
73911935|NCT02195583|147353728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.87|||<|0.0001|TWO_SIDED|95.0|7.36|12.37|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426 ppm) + zinc base A' such that a positive difference favors Sodium fluoride (1426 ppm).|||12.37|7.36|<0.0001
73911936|NCT02195583|147353728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.26|||<|0.0001|TWO_SIDED|95.0|6.77|11.75|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426ppm) + zinc base B' such that a positive difference favors Sodium fluoride (1426 ppm).|||11.75|6.77|<0.0001
73911937|NCT01945281|147353760|OTHER|Miettinen \& Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel's weights.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-24.3|27.7|||||Caspofungin minus Amphotericin|||27.7|-24.3|
73911938|NCT01945281|147353761|OTHER|Miettinen \& Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel's weights.|Difference in Percentage|-6.3|||||TWO_SIDED|95.0|-30.2|22.6|||||Caspofungin minus Amphotericin|||22.6|-30.2|
73911939|NCT02983825|147353777|SUPERIORITY|Wilcoxon signed-rank test for nonparametric matched-pairs||||||0.02|||||||Sign test|||"Within subject repeat analysis; V/Q mismatch (measured as degree of right shift in kPa) baseline vs best CPAP"||||0.02
73911940|NCT01702805|147353779|SUPERIORITY||Risk Ratio (RR)|1.0||||0.93|TWO_SIDED|95.0|0.92|1.1|||Robust Poisson Regression|The relative risk was adjusted for birth-weight and center stratum.||Null hypothesis: A higher hemoglobin threshold for red-cell transfusions, as compared with a lower threshold, will not reduce nor increase the incidence of death or neurodevelopmental impairment in infants at 22 to 26 months of age corrected for prematurity.||1.10|0.92|0.93
73911941|NCT00181155|147353815|SUPERIORITY_OR_OTHER||||||<|0.007||95.0||||vs. baseline|Two-sided paired t tests|||||||<0.007
73911942|NCT00181155|147353816|SUPERIORITY_OR_OTHER||||||<|0.02||95.0||||vs. baseline|Two-sided paired t tests|||||||<0.02
73911943|NCT01323959|147353834|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|96.8|||||TWO_SIDED|95.0|89.0|99.6|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|"The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, 1 month after the booster dose, in at least 80% of the subjects against diphtheria.~Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing."||99.6|89|
73858218|NCT00642174|147261913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.7|||<|0.0001||95.0|10.27|25.04||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours post-Last Maintenance Dose (LMD).||25.04|10.27|<0.0001
73858219|NCT00642174|147261914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.5466||95.0|-3.66|1.97||P-value for Baseline (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||1.97|-3.66|0.5466
73858220|NCT00642174|147261914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.0|||<|0.0001||95.0|-28.45|-17.55||P-value for 1 After Post Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-17.55|-28.45|<0.0001
73858221|NCT00642174|147261914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.6|||<|0.0001||95.0|-31.18|-22.02||P-value for 4 Hour After Loading Dose (5 uM ADP). A priori threshold for statisitical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-22.02|-31.18|<0.0001
73858222|NCT00642174|147261914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.3|||<|0.0001||95.0|-27.42|-19.17||P-value for 24 Hour After Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-19.17|-27.42|<0.0001
73858223|NCT00642174|147261914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.7||||0.0001||95.0|-12.78|-4.58||P-value for 24 Hour After Last Maintenance Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-4.58|-12.78|0.0001
73911944|NCT01323959|147353834|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|95.7|||||TWO_SIDED|95.0|87.8|99.1|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||99.1|87.8|
73965126|NCT04714320|147465417|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.867
73965127|NCT04714320|147465417|SUPERIORITY||||||=|0.761||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.761
73911945|NCT01323959|147353834|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|100.0|||||TWO_SIDED|95.0|94.8|100.0|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||100|94.8|
73911946|NCT01323959|147353836|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|92.1|||||TWO_SIDED|95.0|82.4|97.4|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to dose in study NCT01277705. Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing.||97.4|82.4|
73911947|NCT01323959|147353836|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|79.4|||||TWO_SIDED|95.0|67.9|88.3|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||88.3|67.9|
73911948|NCT01323959|147353836|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|84.1|||||TWO_SIDED|95.0|73.3|91.8|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||91.8|73.3|
73911949|NCT02762578|147353857|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Non-inferiority with respect to change from baseline in HbA1c (%) to week 26 for IDegAsp vs. BIAsp 30.~Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%."|Treatment contrast|-0.08||||0.243|TWO_SIDED|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.||0.05|-0.20|0.2430
73911950|NCT02762578|147353857|SUPERIORITY|"If non-inferiority was confirmed, the superiority of the IDegAsp group over the BIAsp 30 group was to be investigated.~Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval, which was calculated using the FAS, was below 0%."|Treatment contrast|-0.08||||0.243|TWO_SIDED|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.||0.05|-0.20|0.2430
73911951|NCT02762578|147353858|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Superiority with respect to change from baseline in FPG to week 26 for IDegAsp vs. BIAsp 30 (Provided that non-inferiority was confirmed for the primary endpoint)~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group-BIAsp 30 group) was entirely below zero."|Treatment Contrast|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.1||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in FPG after 26 weeks of treatment was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline FPG as covariates.||-1.10|-1.74|<0.0001
73911952|NCT02762578|147353859|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: Superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in FPG to week 26 was confirmed for IDegAsp vs. BIAsp 30).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.53||||0.0112|TWO_SIDED|95.0|0.33|0.87|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate.||0.87|0.33|0.0112
73911953|NCT02762578|147353860|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.57||||0.0002|TWO_SIDED|95.0|0.42|0.77|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate||0.77|0.42|0.0002
73965128|NCT04714320|147465417|SUPERIORITY||||||=|0.618||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.618
73965129|NCT04714320|147465417|SUPERIORITY||||||=|0.363||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received are included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||=0.363
73965130|NCT04714320|147465417|SUPERIORITY||||||=|0.125||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received are included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||=0.125
73911954|NCT02762578|147353861|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: Superiority with respect to change from baseline in body weight for IDegAsp vs. BIAsp 30 (provided that Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group-BIAsp 30 group) was entirely below zero"|Treatment contrast|0.61||||0.0092|TWO_SIDED|95.0|0.15|1.08|||ANCOVA|Two-sided p-value for testing difference||The response and change from baseline in response after 26 weeks were analysed using an ANCOVA model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate.||1.08|0.15|0.0092
73965131|NCT04714320|147465417|SUPERIORITY||||||=|0.435||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.435
73965132|NCT04714320|147465417|SUPERIORITY||||||=|0.413||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.413
73965133|NCT04714320|147465417|SUPERIORITY||||||=|0.658||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.658
73965134|NCT04714320|147465417|SUPERIORITY||||||=|0.275||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.275
73965135|NCT04714320|147465417|SUPERIORITY||||||=|0.578||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.578
73965136|NCT04714320|147465417|SUPERIORITY||||||=|0.114||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.114
73965137|NCT04714320|147465418|SUPERIORITY||||||=|0.378||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.378
73965138|NCT04714320|147465418|SUPERIORITY||||||=|0.648||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.648
74026713|NCT01287117|147607055|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.96||||0.001|TWO_SIDED|95.0|-4.71|-1.21||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-1.21|-4.71|0.0010
73965139|NCT04714320|147465418|SUPERIORITY||||||=|0.961||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.961
73965140|NCT04714320|147465418|SUPERIORITY||||||=|0.817||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.817
73965141|NCT04714320|147465418|SUPERIORITY||||||=|0.823||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.823
73965142|NCT04714320|147465418|SUPERIORITY||||||=|0.362||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.362
73965143|NCT04714320|147465418|SUPERIORITY||||||=|0.66||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.660
73965144|NCT04714320|147465418|SUPERIORITY||||||=|0.539||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.539
73965145|NCT04714320|147465418|SUPERIORITY||||||=|0.43||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.430
73965146|NCT04714320|147465418|SUPERIORITY||||||=|0.594||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.594
73965147|NCT04714320|147465418|SUPERIORITY||||||=|0.783||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.783
73965148|NCT04714320|147465418|SUPERIORITY||||||=|0.599||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.599
73965149|NCT04714320|147465418|SUPERIORITY||||||=|0.454||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.454
73911955|NCT02762578|147353862|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 6: Superiority with respect to subjects achieving HbA1c \< 7% at end of trial without confirmed hypoglycaemia for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in body weight was confirmed).~Superiority was considered confirmed if the 95% CI for the odds ratio (IDegAsp group/BIAsp 30 group) was entirely above one."|Treatment Ratio|2.22||||0.0002|TWO_SIDED|95.0|1.47|3.35||Two-sided p-value for testing difference|Regression, Logistic|||The endpoint was analysed in a logistic regression model using a logit link, including treatment, sex and anti-diabetic treatment at screening as fixed effects, and age and HbA1c as covariates.||3.35|1.47|0.0002
73911956|NCT01611155|147353914|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
74088360|NCT03694808|147730156|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.154|||||TWO_SIDED|95.0|-0.001|0.308|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.308|-0.001|
73911957|NCT01611155|147353915|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||Motor subscale||||0.53
73911958|NCT01611155|147353915|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||autonomic subscale||||0.89
73911959|NCT03344796|147353937|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
73911960|NCT03344796|147353938|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
73911961|NCT03344796|147353939|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
73911962|NCT03344796|147353940|SUPERIORITY||||||<|0.1|||||||Chi-squared|||Knowledge of sun protection score at baseline compared with score after completion of the arm. The hypothesis is that the focus group, usability test and structured interviews arms will not have significant change in knowledge. It is expected that cohort studies 1 and 2 will have significant change in knowledge of sun protection.||||< 0.1
73911963|NCT00453063|147353948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.001
73911964|NCT00453063|147353949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.304||95.0|||||ANCOVA|||||||0.304
73911965|NCT00453063|147353950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||ANCOVA|||||||0.004
73911966|NCT00453063|147353951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0|||||ANCOVA|||||||0.063
73911967|NCT00453063|147353952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.356||95.0|||||ANCOVA|||||||0.356
73911968|NCT00289783|147353953|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by Enzyme Linked Immunosorbent Assay (ELISA) the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.42|0.89|
73911969|NCT00289783|147353953|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.42|0.89|
73911970|NCT00289783|147353953|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.8|1.26||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.26|0.8|
73911971|NCT00289783|147353954|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.23|||||TWO_SIDED|95.0|0.93|1.62||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.62|0.93|
73911972|NCT00289783|147353954|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.97|||||TWO_SIDED|95.0|0.74|1.29||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.29|0.74|
73911973|NCT00289783|147353954|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.79|||||TWO_SIDED|95.0|0.6|1.04||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.04|0.6|
73911974|NCT00289783|147353955|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.61|||||TWO_SIDED|95.0|1.14|2.27||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||2.27|1.14|
73965150|NCT04714320|147465418|SUPERIORITY||||||=|0.394||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.394
73965151|NCT04714320|147465418|SUPERIORITY||||||=|0.93||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.930
73965152|NCT04714320|147465418|SUPERIORITY||||||=|0.313||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.313
73965153|NCT04714320|147465418|SUPERIORITY||||||=|0.276||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.276
73965154|NCT04714320|147465418|SUPERIORITY||||||=|0.168||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.168
73965155|NCT04714320|147465418|SUPERIORITY||||||=|0.199||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.199
73965156|NCT04714320|147465418|SUPERIORITY||||||=|0.506||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.506
73965157|NCT04714320|147465418|SUPERIORITY||||||=|0.32||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.320
73965158|NCT04714320|147465418|SUPERIORITY||||||=|0.25||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.250
73965159|NCT04714320|147465418|SUPERIORITY||||||=|0.373||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.373
74026714|NCT01287117|147607055|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.95||||0.0012|TWO_SIDED|95.0|-4.72|-1.18||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.18|-4.72|0.0012
73965160|NCT04714320|147465418|SUPERIORITY||||||=|0.597||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.597
73965161|NCT04714320|147465418|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.867
73965162|NCT04714320|147465418|SUPERIORITY||||||=|0.5||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.500
73965163|NCT04714320|147465418|SUPERIORITY||||||=|0.863||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 106||||=0.863
73965164|NCT04714320|147465418|SUPERIORITY||||||=|0.681||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 106||||=0.681
73965165|NCT04714320|147465418|SUPERIORITY||||||=|0.262||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.262
73965166|NCT04714320|147465418|SUPERIORITY||||||=|0.645||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.645
73965167|NCT04714320|147465418|SUPERIORITY||||||=|0.947||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.947
73965168|NCT04714320|147465418|SUPERIORITY||||||=|0.665||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.665
73965169|NCT04714320|147465418|SUPERIORITY||||||=|0.498||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.498
73965170|NCT04714320|147465418|SUPERIORITY||||||=|0.173||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.173
73965171|NCT05057897|147465423|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.18|3.01|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 57 (28 days post Dose 2)||3.01|0.18|
73965172|NCT05057897|147465424|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|-30.36|||||TWO_SIDED|95.0|-62.82|3.69||||The 2-sided 95% CI was calculated using the Newcombe score without continuity correction.|The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 57 (28 days post Dose 2)||3.69|-62.82|
73911975|NCT00289783|147353955|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.4|||||TWO_SIDED|95.0|0.99|1.97||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||1.97|0.99|
73911976|NCT00289783|147353955|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.87|||||TWO_SIDED|95.0|0.62|1.21||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||1.21|0.62|
73911977|NCT00289783|147353956|NON_INFERIORITY|Criteria for immunogenicity of MenC (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|12.0|||||TWO_SIDED|95.0|10.4|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.||13.8|10.4|
73911978|NCT00289783|147353956|NON_INFERIORITY|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values)|GMT ratio|1.4|||||TWO_SIDED|95.0|1.4|1.4||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.||1.4|1.4|
73911979|NCT00289783|147353957|NON_INFERIORITY|Criteria for immunogenicity of MenY (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|11.8|||||TWO_SIDED|95.0|10.2|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.||13.8|10.2|
73911980|NCT00289783|147353957|NON_INFERIORITY|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values).|GMT ratio|21.1|||||TWO_SIDED|95.0|21.1|21.1||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.||21.1|21.1|
73911981|NCT00289783|147353961|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 150 mIU/mL, in initially seronegative subjects (\<150 mIU/mL), for anti-measles antibody is ≥-5% (clinical limit for non-inferiority).|Difference in percentage|-0.15|||||TWO_SIDED|95.0|-2.56|3.06||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||3.06|-2.56|
73911982|NCT00289783|147353962|NON_INFERIORITY|Criteria for non-inferiority (42 days after the fourth dose): Lower limit of the two-sided standardized asymptotic 95% CI on the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with anti-PRP concentration ≥ 1.0 µg/mL is ≥ -10% (clinical limit for non-inferiority)|Difference in percentage|-0.04|||||TWO_SIDED|95.0|-1.78|3.57||||||To demonstrate that, following a fourth dose, the immune response to Hib polysaccharide (PRP) in the group that received 3 primary vaccine doses of Menhibrix vaccine and a fourth dose of Menhibrix vaccine coadministered with M-M-R II and Varivax vaccines was non-inferior to the corresponding immune response in the group that received 3 primary vaccine doses of ActHIB vaccine and a fourth dose of PedvaxHIB vaccine co-administered with M-M-R II and Varivax vaccines.||3.57|-1.78|
73911983|NCT00289783|147353963|NON_INFERIORITY|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with a seroconversion ≥28 ED50, in subjects with initial anti-mumps antibody \< 28 ED50, for anti-mumps antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|-1.0|||||TWO_SIDED|95.0|-2.16|0.98||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M--M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||0.98|-2.16|
73965173|NCT05057897|147465425|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.47|||||TWO_SIDED|95.0|0.06|3.86|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 57 (28 days post Dose 2)||3.86|0.06|
73965174|NCT05057897|147465426|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|-25.0|||||TWO_SIDED|95.0|-59.07|2.97||||The 2-sided 95% CI was calculated using the Newcombe score without continuity correction.|The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 57 (28 days post Dose 2)||2.97|-59.07|
73965175|NCT05057897|147465427|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.32|||||TWO_SIDED|95.0|0.12|0.8|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||0.80|0.12|
73965176|NCT05057897|147465428|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|0.0||||||||||||Due to everyone in both cohorts being a seroresponder, the confidence interval (CI) around the difference is not estimable.|The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||||
73965177|NCT05057897|147465429|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.56|||||TWO_SIDED|95.0|0.25|1.25|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||1.25|0.25|
73911984|NCT00289783|147353964|NON_INFERIORITY|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroresponse ≥10 IU/ml, in initially seronegative subjects (\< 4 IU/ml), for anti-rubella antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|0.12|||||TWO_SIDED|95.0|-0.57|1.73||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||1.73|-0.57|
73911985|NCT00289783|147353965|NON_INFERIORITY|Criterion for non-inferiority (42 days after the fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 1:5 dilution, in initially seronegative subjects (\< 1:5), for anti-varicella antibody is ≥ -10% (clinical limit for non-inferiority).|Difference in percentage|-0.14|||||TWO_SIDED|95.0|-0.78|1.56||||||To demonstrate the non-inferiority of Varivax vaccine co-administered with a fourth dose of Menhibrix vaccine compared to Varivax vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with M-M-R II vaccine in terms of immunogenicity to varicella as measured by fluorescent antibody to membrane antigen (FAMA).||1.56|-0.78|
73911986|NCT04547712|147354051|SUPERIORITY||Proportion expressed as a percentage|78.9|||||ONE_SIDED|97.5|59.4||||||The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.|"Null Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold \<= 50%; Alternative Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold \> 50%"|||59.4|
73911987|NCT04547712|147354051|SUPERIORITY||Proportion expressed as a percentage|91.0|||||ONE_SIDED|97.5|75.6||||||The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.|"Null Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold \<= 50%; Alternative Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold \> 50%"|||75.6|
73911988|NCT04547712|147354052|SUPERIORITY|||||||0.012||||||Nominal p-value is provided.|t-test, 2 sided|||Null Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \>= 0; Alternative Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \< 0||||0.0120
73911989|NCT04547712|147354052|SUPERIORITY|||||||0.0491||||||Nominal p-value is provided.|t-test, 2 sided|||Null Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \>= 0; Alternative Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \< 0||||0.0491
73911990|NCT03298867|147354054|SUPERIORITY||Stratified difference in percentages|73.45|STANDARD_ERROR_OF_MEAN|7.43|<|0.001|TWO_SIDED|95.0|58.89|88.01||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with Cochran-Mantel-Haenszel (CMH) weights.|||88.01|58.89|<0.001
73965178|NCT05057897|147465430|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|0.0||||||||||||Due to everyone in both cohorts being a seroresponder, the confidence interval (CI) around the difference is not estimable.|The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||||
73965179|NCT03363854|147465431|SUPERIORITY||Risk Difference (RD)|12.4||||0.015|TWO_SIDED|95.0|2.9|21.9||The primary endpoints were tested sequentially at a 5% significance level.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants who achieved IGA 0 or 1 at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their IGA value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.||21.9|2.9|0.015
73911991|NCT03298867|147354055|SUPERIORITY||Stratified difference in percentages|70.82|STANDARD_ERROR_OF_MEAN|7.62|<|0.001|TWO_SIDED|95.0|55.89|85.75||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||85.75|55.89|<0.001
73911992|NCT03298867|147354056|SUPERIORITY||Stratified difference in percentages|36.03|STANDARD_ERROR_OF_MEAN|9.51|<|0.001|TWO_SIDED|95.0|17.39|54.67||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||54.67|17.39|<0.001
73911993|NCT03298867|147354057|SUPERIORITY||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|0.244|<|0.001|TWO_SIDED|95.0|-2.77|-1.8||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed model for repeated measures (MMRM)|||||-1.80|-2.77|<0.001
73911994|NCT03298867|147354058|SUPERIORITY||Stratified difference in percentages|39.29|STANDARD_ERROR_OF_MEAN|12.11||0.001|TWO_SIDED|95.0|15.55|63.02||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||63.02|15.55|0.001
73965180|NCT03363854|147465432|SUPERIORITY||Risk Difference (RD)|20.2|||<|0.001|TWO_SIDED|95.0|9.8|30.6||The primary endpoints were tested sequentially at a 5% significance level.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants who achieved at least 75% reduction in EASI at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.||30.6|9.8|<0.001
73965181|NCT03363854|147465433|SUPERIORITY||Risk Difference (RD)|11.3||||0.037|TWO_SIDED|95.0|0.9|21.6||This secondary endpoint was tested after the sequential testing of the primary endpoints, if these showed statistical significance.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their Worst daily Pruritus NRS value at Week 16.||21.6|0.9|0.037
73965182|NCT03363854|147465434|SUPERIORITY||Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-15.2|-6.6||This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-6.6|-15.2|<0.001
73965183|NCT03363854|147465435|SUPERIORITY||Difference|-2.9|||<|0.001|TWO_SIDED|95.0|-4.3|-1.6||This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after sequential testing of the primary endpoints and the first secondary endpoint, if these showed statistical significance.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-1.6|-4.3|<0.001
73965184|NCT03363854|147465437|SUPERIORITY||Difference|-3.5||||0.41|TWO_SIDED|95.0|-11.9|4.9||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.||4.9|-11.9|0.41
73965185|NCT03363854|147465437|SUPERIORITY||Difference|-6.9||||0.033|TWO_SIDED|95.0|-13.3|-0.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.||-0.6|-13.3|0.033
73965186|NCT03363854|147465437|SUPERIORITY||Difference|-4.7||||0.12|TWO_SIDED|95.0|-10.6|1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.||1.2|-10.6|0.12
73965187|NCT03363854|147465437|SUPERIORITY||Difference|-7.3||||0.043|TWO_SIDED|95.0|-14.3|-0.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.||-0.2|-14.3|0.043
74026715|NCT01287117|147607055|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.8|||<|0.0001|TWO_SIDED|95.0|-7.49|-4.1||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.10|-7.49|<0.0001
74026716|NCT01287117|147607056|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.75||||0.0035|TWO_SIDED|95.0|-9.59|-1.92||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-1.92|-9.59|0.0035
73965188|NCT03363854|147465437|SUPERIORITY||Difference|-9.1||||0.002|TWO_SIDED|95.0|-14.8|-3.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.||-3.4|-14.8|0.002
73965189|NCT03363854|147465437|SUPERIORITY||Difference|-8.0||||0.001|TWO_SIDED|95.0|-12.8|-3.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.||-3.2|-12.8|0.001
73965190|NCT03363854|147465437|SUPERIORITY||Difference|-10.2|||<|0.001|TWO_SIDED|95.0|-15.8|-4.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.||-4.7|-15.8|<0.001
73965191|NCT03363854|147465437|SUPERIORITY||Difference|-8.6||||0.002|TWO_SIDED|95.0|-14.1|-3.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.||-3.2|-14.1|0.002
73965192|NCT03363854|147465438|SUPERIORITY||Difference|0.0||||1|TWO_SIDED|95.0|-11.0|11.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.||11.0|-11.0|1.00
73911995|NCT03298867|147354059|SUPERIORITY||Difference in LS mean|9.36|STANDARD_ERROR_OF_MEAN|2.651|<|0.001|TWO_SIDED|95.0|4.08|14.64||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed model for repeated measures (MMRM)|||||14.64|4.08|<0.001
73911996|NCT04997304|147354149|OTHER|Test of paired differences||||||0.0019|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.0019
73911997|NCT04997304|147354149|OTHER|Test of paired differences||||||0.002|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0020
73911998|NCT04997304|147354150|OTHER|Test of paired differences||||||0.0008|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.0008
73911999|NCT04997304|147354150|OTHER|Test of paired differences||||||0.0003|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0003
73912000|NCT04997304|147354151|OTHER|Test of paired differences||||||0.04|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.04
73912001|NCT04997304|147354151|OTHER|Test of paired differences||||||0.0965|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0965
73912002|NCT01663532|147354198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.0005|TWO_SIDED|95.0|-6.1|-1.7||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-1.7|-6.1|0.0005
73912003|NCT01663532|147354198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.0||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-4.0|-10.0|<.0001
73965193|NCT03363854|147465438|SUPERIORITY||Difference|1.1||||0.83|TWO_SIDED|95.0|-9.1|11.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.||11.4|-9.1|0.83
73965194|NCT03363854|147465438|SUPERIORITY||Difference|-1.4||||0.78|TWO_SIDED|95.0|-11.3|8.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.||8.5|-11.3|0.78
73965195|NCT03363854|147465438|SUPERIORITY||Difference|-4.8||||0.34|TWO_SIDED|95.0|-14.8|5.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.||5.1|-14.8|0.34
74026717|NCT01287117|147607056|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.54||||0.0008|TWO_SIDED|95.0|-10.33|-2.75||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-2.75|-10.33|0.0008
74026718|NCT01287117|147607056|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.8|||<|0.0001|TWO_SIDED|95.0|-16.44|-9.16||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-9.16|-16.44|<0.0001
74026719|NCT01287117|147607057|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.75||||0.0149|TWO_SIDED|95.0|-4.95|-0.54||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-0.54|-4.95|0.0149
74088361|NCT03694808|147730156|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.056|||||TWO_SIDED|95.0|-0.2|0.089|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.089|-0.2|
73912004|NCT01663532|147354198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||<|0.0001|TWO_SIDED|95.0|-12.8|-5.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-5.6|-12.8|<.0001
73912005|NCT01663532|147354198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||<|0.0001|TWO_SIDED|95.0|-15.0|-7.3||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-7.3|-15.0|<.0001
73912006|NCT01663532|147354198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-18.4|-9.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-9.6|-18.4|<.0001
73912007|NCT01663532|147354198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.1|||<|0.0001|TWO_SIDED|95.0|-19.4|-10.8||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-10.8|-19.4|<.0001
73912008|NCT01663532|147354199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0001|TWO_SIDED|95.0|-0.4|-0.1||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.1|-0.4|0.0001
73912009|NCT01663532|147354199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.2||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.2|-0.6|<.0001
73965196|NCT03363854|147465438|SUPERIORITY||Difference|-4.4||||0.34|TWO_SIDED|95.0|-13.4|4.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.||4.6|-13.4|0.34
73965197|NCT03363854|147465438|SUPERIORITY||Difference|-6.2||||0.11|TWO_SIDED|95.0|-13.9|1.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.||1.5|-13.9|0.11
73965198|NCT03363854|147465438|SUPERIORITY||Difference|-8.9||||0.024|TWO_SIDED|95.0|-16.6|-1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.||-1.2|-16.6|0.024
73912010|NCT01663532|147354199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.4|-0.7|<.0001
73912011|NCT01663532|147354199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.5|-0.9|<.0001
73912012|NCT01663532|147354199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.5|-0.9|<.0001
73912013|NCT01663532|147354199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.6|-1.1|<.0001
73912014|NCT01663532|147354200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.0006|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.6|-2.1|0.0006
73912015|NCT01663532|147354200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.3|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.3|-3.3|<.0001
73912016|NCT01663532|147354200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.0001|TWO_SIDED|95.0|-4.3|-2.0|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-2.0|-4.3|<.0001
73912017|NCT01663532|147354200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.1|-2.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-2.6|-5.1|<.0001
73912018|NCT01663532|147354200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|||<|0.0001|TWO_SIDED|95.0|-6.2|-3.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-3.4|-6.2|<.0001
73912019|NCT01663532|147354200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.7|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-3.7|-6.4|<.0001
73965199|NCT03363854|147465438|SUPERIORITY||Difference|-9.5||||0.017|TWO_SIDED|95.0|-17.3|-1.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.||-1.7|-17.3|0.017
73912020|NCT01663532|147354201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.0023|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.3|-1.6|0.0023
73912021|NCT01663532|147354201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.0032|TWO_SIDED|95.0|-2.0|-0.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.4|-2.0|0.0032
73912022|NCT01663532|147354201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.0003|TWO_SIDED|95.0|-2.7|-0.8|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.8|-2.7|0.0003
73912023|NCT01663532|147354201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.3|-3.2|<.0001
73912024|NCT01663532|147354201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.7|-1.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.4|-3.7|<.0001
73912025|NCT01663532|147354201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.1|-1.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.6|-4.1|<.0001
73912026|NCT01663532|147354202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||<|0.0001|TWO_SIDED|95.0|4.1|10.1|||ANCOVA|ANCOVA model with treatment and pooled centers as factors and Baseline value as covariate for the comparison at other visits.|Difference in least square mean of change were derived from ANCOVA model.|Statistical analysis for Week 10.||10.1|4.1|<.0001
73912027|NCT01663532|147354203|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|CMH raw mean scores differ test (Van Elteren test) controlling for pooled centers.||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.||||<.0001
73912028|NCT01663532|147354204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|||<|0.0001|TWO_SIDED|95.0|12.9|32.4|||Cochran-Mantel-Haenszel|CMH test controlling by region (pooled sites).||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.||32.4|12.9|<.0001
73912029|NCT01633853|147354205|SUPERIORITY_OR_OTHER|||||||0.117|TWO_SIDED||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline both in group Vitamin D2.||||0.117
73912030|NCT01633853|147354205|SUPERIORITY_OR_OTHER|||||||0.309|TWO_SIDED||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline in group 1,25(OH)2 Vitamin D3.||||0.309
73912031|NCT01633853|147354205|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED|||||t=-0.593|t-test, 2 sided|||The levels of blood calcium at the 24th month of following up were compared between two groups.||||0.554
73965200|NCT03363854|147465440|SUPERIORITY||Difference|0.1||||0.64|TWO_SIDED|95.0|-0.5|0.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1 are reported below.||0.7|-0.5|0.64
73912032|NCT01633853|147354206|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group Vitamin D2.||||<0.001
73912033|NCT01633853|147354206|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group 1,25(OH)2 Vitamin D3.||||<0.001
73912034|NCT01633853|147354206|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P\<0.001, t=-14.982.|t-test, 2 sided|||The levels of blood 25(OH) Vitamin D at the 24th month of following up were compared between two groups.||||<0.001
73912035|NCT01633853|147354207|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||Chi-square value=0.099|Chi-squared|||||||0.753
73912036|NCT01633853|147354208|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group Vitamin D2.||||<0.001
73912037|NCT01633853|147354208|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group 1,25(OH)2 Vitamin D3, respectively.||||<0.001
73912038|NCT01633853|147354208|SUPERIORITY_OR_OTHER|||||||0.694|TWO_SIDED|||||t=0.394|t-test, 2 sided|||The levels of blood phosphorus at the 24th month of following up were compared between two groups.||||0.694
73912039|NCT01633853|147354209|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline in group Vitamin D2.||||0.179
73912040|NCT01633853|147354209|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline group 1,25(OH)2 Vitamin D3, respectively.||||0.106
73912041|NCT01633853|147354209|SUPERIORITY_OR_OTHER|||||||0.463|TWO_SIDED|||||t=-0.736|t-test, 2 sided|||The levels of blood iPTH at the 24th month of following up were compared between two groups.||||0.463
73912042|NCT02785432|147354210|SUPERIORITY|||||||0.55||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.55
73912043|NCT02785432|147354211|SUPERIORITY|||||||0.66||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.66
73912044|NCT02785432|147354212|SUPERIORITY|||||||0.51||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.51
73912045|NCT02785432|147354213|SUPERIORITY|||||||0.96||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.96
73912046|NCT01673867|147354221|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0015|TWO_SIDED|95.92|0.59|0.89|||Log Rank||HR = Nivolumab over docetaxel|||0.89|0.59|0.0015
73912047|NCT02165215|147354263|SUPERIORITY||Adjusted difference in response rates|7.7||||0.1942|TWO_SIDED|95.0|-4.2|19.2|||Cochran-Mantel-Haenszel|||||19.2|-4.2|0.1942
73912048|NCT02165215|147354264|SUPERIORITY||Adjusted difference in remission rates|14.6||||0.1524|TWO_SIDED|95.0|-5.55|33.15||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||33.15|-5.55|0.1524
73912049|NCT02165215|147354265|SUPERIORITY||Adjusted difference in remission rates|8.7||||0.1466|TWO_SIDED|95.0|-3.26|20.21||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||20.21|-3.26|0.1466
73912050|NCT02165215|147354266|SUPERIORITY||Adjusted difference in remission rates|10.9||||0.3083||95.0|-9.72|30.49||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||30.49|-9.72|0.3083
73912051|NCT02165215|147354267|SUPERIORITY||Adjusted difference in response rates|14.4||||0.0235|TWO_SIDED|95.0|1.84|26.28||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||26.28|1.84|0.0235
73912052|NCT02165215|147354268|SUPERIORITY||Adjusted difference in remission rates|12.8||||0.0293||95.0|1.13|23.89||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.89|1.13|0.0293
73912053|NCT02165215|147354269|SUPERIORITY||Adjusted difference in remission rates|19.8||||0.0075|TWO_SIDED|95.0|5.16|33.11||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||33.11|5.16|0.0075
73912054|NCT02165215|147354270|SUPERIORITY||Adjusted difference in remission rates|9.9||||0.1415||95.0|-4.47|23.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.13|-4.47|0.1415
73912055|NCT02165215|147354271|SUPERIORITY||Adjusted difference in remission rates|9.9||||0.1415||95.0|-4.47|23.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.13|-4.47|0.1415
73912056|NCT02165215|147354272|SUPERIORITY||Difference in Least Square Means|-2.8||||0.0266|TWO_SIDED|95.0|-5.3|-0.4||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-0.4|-5.3|0.0266
73912057|NCT02165215|147354273|SUPERIORITY||Difference in Least Square Means|-1.2||||0.0175|TWO_SIDED|95.0|-2.2|-0.2||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-0.2|-2.2|0.0175
73912058|NCT02165215|147354274|SUPERIORITY||Difference in Adjusted Mean|2.1||||0.6331|TWO_SIDED|95.0|-6.6|10.8||p-value has not been adjusted for multiplicity|ANCOVA|||||10.8|-6.6|0.6331
73912059|NCT02096731|147354301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.92|1.37|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.37|0.92|
73912060|NCT02096731|147354302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.1|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.10|0.69|
73912061|NCT02096731|147354303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|1.03|1.3|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.30|1.03|
73912062|NCT02096731|147354304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.81|1.36|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.36|0.81|
73912063|NCT02096731|147354305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|1.23|1.5|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.50|1.23|
73912064|NCT03719612|147354333|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.38|STANDARD_DEVIATION|4.947||0.358|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.358
73912065|NCT03719612|147354333|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|5.699||0.804|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.804
73912066|NCT03719612|147354333|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|4.412||0.371|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.371
73912067|NCT03719612|147354334|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-1.28|STANDARD_DEVIATION|3.952||0.03|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.030
73912068|NCT03719612|147354334|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.66|STANDARD_DEVIATION|4.466||0.312|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.312
73912069|NCT03719612|147354334|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.65|STANDARD_DEVIATION|4.725||0.347|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.347
73912070|NCT03719612|147354335|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.977|0.988||||||Inter-Reader Variability Echo Enhanced||0.988|0.977|
73912071|NCT03719612|147354335|OTHER||Intra-class Correlation Coefficient|0.953|||||TWO_SIDED|95.0|0.936|0.966||||||Inter-Reader Variability Echo Unenhanced||0.966|0.936|
73912072|NCT03719612|147354335|OTHER||Intra-class Correlation Coefficient|0.97|||||TWO_SIDED|95.0|0.958|0.978||||||Inter-Reader Variability Echo Enhanced||0.978|0.958|
73912073|NCT03719612|147354335|OTHER||Intra-class Correlation Coefficient|0.944|||||TWO_SIDED|95.0|0.923|0.959||||||Inter-Reader Variability Echo Unenhanced||0.959|0.923|
73912074|NCT03719612|147354335|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.947|0.972||||||Inter-Reader Variability Echo Enhanced||0.972|0.947|
73912075|NCT03719612|147354335|OTHER||Intra-class Correlation Coefficient|0.942|||||TWO_SIDED|95.0|0.92|0.958||||||Inter-Reader Variability Echo Unenhanced||0.958|0.920|
73912076|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.978|0.988||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.988|0.978|
73912077|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.967|0.983||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.983|0.967|
73912078|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.963|0.981||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.981|0.963|
73912079|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.935|||||TWO_SIDED|95.0|0.91|0.952||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.952|0.910|
73912080|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.962|0.98||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.980|0.962|
73912081|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.924|||||TWO_SIDED|95.0|0.896|0.945||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.945|0.896|
73912082|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.989|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-Reader Variability End Systolic Echo Enhanced||0.992|0.984|
73912083|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.983|||||TWO_SIDED|95.0|0.977|0.988||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.988|0.977|
73912084|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.978|0.989||||||Inter-Reader Variability End Systolic Echo Enhanced||0.989|0.978|
73912085|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.928|0.962||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.962|0.928|
73912086|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.978|||||TWO_SIDED|95.0|0.969|0.984||||||Inter-Reader Variability End Systolic Echo Enhanced||0.984|0.969|
73912087|NCT03719612|147354336|OTHER||Intra-class Correlation Coefficient|0.942|||||TWO_SIDED|95.0|0.92|0.958||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.958|0.920|
73912088|NCT03719612|147354337|OTHER||Intra-class Correlation Coefficient|0.975|||||TWO_SIDED|95.0|0.956|0.986||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.986|0.956|
73912089|NCT03719612|147354337|OTHER||Intra-class Correlation Coefficient|0.936|||||TWO_SIDED|95.0|0.888|0.963||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.963|0.888|
73912090|NCT03719612|147354337|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.931|0.978||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.978|0.931|
73912091|NCT03719612|147354337|OTHER||Intra-class Correlation Coefficient|0.921|||||TWO_SIDED|95.0|0.864|0.955||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.955|0.864|
73912092|NCT03719612|147354337|OTHER||Intra-class Correlation Coefficient|0.947|||||TWO_SIDED|95.0|0.907|0.97||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.970|0.907|
73912093|NCT03719612|147354337|OTHER||Intra-class Correlation Coefficient|0.903|||||TWO_SIDED|95.0|0.834|0.945||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.945|0.834|
73912094|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.971|0.991||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.991|0.971|
73912095|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.975|||||TWO_SIDED|95.0|0.956|0.986||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.986|0.956|
73912096|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.959|0.987||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.987|0.959|
73912097|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.94|||||TWO_SIDED|95.0|0.896|0.966||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.966|0.896|
73912098|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.959|0.987||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.987|0.959|
73912099|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.923|||||TWO_SIDED|95.0|0.866|0.956||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.956|0.866|
73912100|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.99|||||TWO_SIDED|95.0|0.982|0.994||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.994|0.982|
73912101|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.957|0.986||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.986|0.957|
73912102|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.985|||||TWO_SIDED|95.0|0.973|0.991||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.991|0.973|
73912103|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.929|||||TWO_SIDED|95.0|0.876|0.959||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.959|0.876|
73912104|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.981|||||TWO_SIDED|95.0|0.966|0.989||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.989|0.966|
73912105|NCT03719612|147354338|OTHER||Intra-class Correlation Coefficient|0.916|||||TWO_SIDED|95.0|0.855|0.952||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.952|0.855|
73912106|NCT01496248|147354341|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73912107|NCT01496248|147354342|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73912108|NCT01496248|147354343|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73912109|NCT01496248|147354344|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73912110|NCT01496248|147354345|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73912111|NCT01496248|147354346|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73912112|NCT01496248|147354347|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73912113|NCT01496248|147354348|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73912114|NCT03948581|147354362|EQUIVALENCE|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with group, treatment, and injection site as fixed effects and weight as a continuous covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9807|||||TWO_SIDED|90.0|0.9011|1.0675||||||||1.0675|0.9011|
73912115|NCT03948581|147354363|EQUIVALENCE|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with group, treatment, and injection site as fixed effects and weight as a continuous covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9981|||||TWO_SIDED|90.0|0.9223|1.0801||||||||1.0801|0.9223|
73912116|NCT03948581|147354364|EQUIVALENCE|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with group, treatment, and injection site as fixed effects and weight as a continuous covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0038|||||TWO_SIDED|90.0|0.9401|1.0719||||||||1.0719|0.9401|
73912117|NCT04457336|147354372|OTHER|Assessment of dose response for change from baseline in log 17-OHP after 12 weeks on double-blind, placebo-controlled treatment (Week 18). Results were obtained by using a repeated measures random coefficient mixed-effects model and are reported as the -2loglikelihood results for both the full (including interaction terms) and reduced (excluding interaction terms) models.||||||0.8051||||||Dose response p-value|Mixed Models Analysis|The result for the -2loglikelihood full model was -580.2550766 log(ng/dL) and -583.2846546 log(ng/dL) for the reduced model.||||||0.8051
73912118|NCT02284516|147354449|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|7.16|STANDARD_ERROR_OF_MEAN|2.096|=|0.0007|TWO_SIDED|95.0|3.04|11.28||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||||11.28|3.04|=0.0007
73912119|NCT02284516|147354450|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|7.85|STANDARD_ERROR_OF_MEAN|1.792|<|0.0001|TWO_SIDED|95.0|4.33|11.37||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||Baseline and Day 14||11.37|4.33|<0.0001
73912120|NCT02284516|147354450|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|9.32|STANDARD_ERROR_OF_MEAN|1.976|<|0.0001|TWO_SIDED|95.0|5.44|13.2||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||Baseline and Day 42||13.20|5.44|<0.0001
73912121|NCT01350492|147354468|SUPERIORITY||Wilks' Lambda|0.939||||0.68|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.680
73912122|NCT01350492|147354469|SUPERIORITY||Wilks' Lambda|0.96||||0.854|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mulitvariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.854
73912123|NCT01350492|147354470|SUPERIORITY|||||||0.0002||||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.0002
73912124|NCT01350492|147354471|SUPERIORITY||Wilks' Lambda|0.857||||0.41|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.41
73912125|NCT01350492|147354472|SUPERIORITY||Wilks' Lambda|0.828||||0.16|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.16
73965201|NCT03363854|147465440|SUPERIORITY||Difference|0.4||||0.26|TWO_SIDED|95.0|-0.3|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 2 are reported below.||1.0|-0.3|0.26
73912126|NCT01350492|147354473|SUPERIORITY||Wilks' Lambda|0.919||||0.66|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.66
73912127|NCT00939640|147354474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED||||||Wilcoxon matched-pairs|||||||.17
73912128|NCT00939640|147354475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon matched-pairs tests|||||||.02
73912129|NCT00939640|147354480|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
73912130|NCT00939640|147354481|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.02
73912131|NCT00005044|147354487|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.45|TWO_SIDED|95.0|0.48|1.39|||Log Rank||Reference level = TAS x 8 weeks|Assuming 40% of deaths in the 8-wk arm from prostate cancer (PC) and that 8-yr DSS would be 79%, 270 PC deaths were required to detect a 33% hazard reduction in the 28-wk arm with 90% power using the log-rank test with a 2-sided significance level of 0.05. Under assumed failure rates, 1,540 patients accrued over 4 years and observed for an additional 6 years were expected to provide the requisite events. This sample accounted for a 10% ineligible/lack-of-data rate and 3 interim analyses.||1.39|0.48|0.45
73912132|NCT00005044|147354488|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.62|TWO_SIDED|95.0|0.79|1.15|||Log Rank|2-sided significance level of 0.05|Reference level = TAS x 8 weeks|With 1540 patients accrued over 4 years and observed for an additional 6 years, determined for the primary endpoint, there would be 90% power to detect a 22% reduction in the hazard of all cause deaths in the 28-week arm, with 2-sided significance level of 0.05. This sample accounted for a 10% ineligible/lack-of-data rate.||1.15|0.79|0.62
73912133|NCT00005044|147354489|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.47|TWO_SIDED|95.0|0.85|1.08|||Log Rank|Significance level = 0.05|Reference level = TAS x 8 weeks|||1.08|0.85|0.47
73965202|NCT03363854|147465440|SUPERIORITY||Difference|0.2||||0.46|TWO_SIDED|95.0|-0.4|0.8||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3 are reported below.||0.8|-0.4|0.46
73965203|NCT03363854|147465440|SUPERIORITY||Difference|0.4||||0.16|TWO_SIDED|95.0|-0.2|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 4 are reported below.||1.0|-0.2|0.16
73912134|NCT00005044|147354490|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.07|TWO_SIDED|95.0|0.4|1.05|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Locoregional progression||1.05|0.40|0.07
73912135|NCT00005044|147354490|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.8|TWO_SIDED|95.0|0.68|1.66|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Distant metastasis||1.66|0.68|0.80
74085453|NCT01396421|147724962|SUPERIORITY_OR_OTHER||Treatment difference|-8.18|||<|0.0001|TWO_SIDED|95.0|-12.0|-4.4||Primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) which included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.|Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed.||-4.40|-12.0|<0.0001
73912136|NCT00005044|147354491|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.74|TWO_SIDED|95.0|0.89|1.17|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Protocol definition||1.17|0.89|0.74
73912137|NCT00005044|147354491|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.79|1.19|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Phoenix definition||1.19|0.79|0.77
73912138|NCT00005044|147354492|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.62|TWO_SIDED|95.0|0.64|1.3|||Log Rank|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|||1.30|0.64|0.62
73912139|NCT01768286|147354511|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
73912140|NCT01768286|147354511|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
73912141|NCT01768286|147354511|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
73912142|NCT01768286|147354511|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
73965204|NCT03363854|147465440|SUPERIORITY||Difference|0.5||||0.13|TWO_SIDED|95.0|-0.1|1.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5 are reported below.||1.1|-0.1|0.13
73965205|NCT03363854|147465440|SUPERIORITY||Difference|0.3||||0.38|TWO_SIDED|95.0|-0.3|0.9||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 6 are reported below.||0.9|-0.3|0.38
73912143|NCT02935842|147354588|OTHER|||||||||||||||||First Reliable Change (RC), Reliable Change Index (RCI) were calculated on every individual score. Further, ANOVAs and t-tests were administered in order to verify differences between groups or interventions. Significance levels were set at p \< .05.|Reliable Change / Reliable Change Index according to Jacobson \& Truax (1991). There, on the basis of every individual score, the change in performance (i.e. BL-4Weeks/ BL-6Months) has been calculated and is reported with level of significance as well as effect size.|||
73858224|NCT00642174|147261914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.8779||95.0|-2.8|3.26||P-value for Baseline (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||3.26|-2.80|0.8779
73858225|NCT00642174|147261914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.2|||<|0.0001||95.0|-32.43|-17.87||P-value for 1 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-17.87|-32.43|<0.0001
73858226|NCT00642174|147261914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.1|||<|0.0001||95.0|-40.32|-29.78||P-value for 4 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-29.78|-40.32|<0.0001
73858227|NCT00642174|147261914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|||<|0.0001||95.0|-36.32|-25.66||P-value for 24 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-25.66|-36.32|<0.0001
73858228|NCT00642174|147261914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.4|||<|0.0001||95.0|-17.19|-7.58||P-value for 24 Hour After Last Maintenance Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-7.58|-17.19|<0.0001
73858229|NCT00642174|147261915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.3692||95.0|-3.6|9.44||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||9.44|-3.60|0.3692
73858230|NCT00642174|147261915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.2|||<|0.0001||95.0|-47.43|-24.98||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-24.98|-47.43|<0.0001
73858231|NCT00642174|147261915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-53.0|||<|0.0001||95.0|-61.89|-44.02||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-44.02|-61.89|<0.0001
73858232|NCT00642174|147261915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.8|||<|0.0001||95.0|-50.03|-35.55||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-35.55|-50.03|<0.0001
73858233|NCT00642174|147261915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.9||||0.0012||95.0|-23.42|-6.37||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set to p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-6.37|-23.42|0.0012
73858234|NCT00642174|147261916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.5238||95.0|-5.35|2.78||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||2.78|-5.35|0.5238
73912144|NCT02935842|147354588|OTHER|||||||0.05|||||||ANOVA|||||||.05
73912145|NCT02935842|147354592|OTHER|||||||0.05|||||||ANOVA|||||||.05
73912146|NCT02935842|147354594|OTHER|||||||0.05|||||||ANOVA|||||||.05
73912147|NCT02774954|147354601|SUPERIORITY|||||||0.35|||||||ANOVA|||||||0.35
73912148|NCT02774954|147354602|SUPERIORITY|||||||0.35|||||||ANOVA|||||||0.35
73912149|NCT04545385|147354603|OTHER||Odds Ratio (OR)|1.49||||0.7817|TWO_SIDED|95.0|0.545|4.071|||Regression, Logistic|||Analysis was performed using logistic regression with fixed effects for treatment, baseline FEV1, weight, age group, and gender.||4.071|0.545|0.7817
73912150|NCT02229383|147354654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.94|-0.54|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||-0.54|-0.94|<0.001
73912151|NCT02229383|147354655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.341|<|0.001|TWO_SIDED|95.0|-2.19|-0.85|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||-0.85|-2.19|<0.001
73912152|NCT02229383|147354656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.76|STANDARD_ERROR_OF_MEAN|5.754|<|0.001|TWO_SIDED|95.0|-39.07|-16.45|||ANCOVA|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use (yes vs. no) as fixed factors; baseline value as covariate.||||-16.45|-39.07|<0.001
73912153|NCT02229383|147354657|SUPERIORITY_OR_OTHER||Difference in percentages|25.6|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).||||||<0.001
73912154|NCT02229383|147354658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.08||0.074|TWO_SIDED|95.0|-4.1|0.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||0.2|-4.1|0.074
73912155|NCT02229383|147354659|SUPERIORITY_OR_OTHER||Difference in percentages|20.0|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).||||||<0.001
73912156|NCT02229383|147354660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.13||0.11|TWO_SIDED|95.0|-4.0|0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||0.4|-4.0|0.110
73912157|NCT02168361|147354663|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Null hypothesis is no difference between two regimens in SVR-12.||||.02
73912158|NCT00758836|147354670|SUPERIORITY_OR_OTHER||Proportion difference|24.5|||<|0.001|TWO_SIDED|90.0|16.7|32.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomial distribution stratified by baseline severity.||||32.2|16.7|<0.001
73912159|NCT00758836|147354670|SUPERIORITY_OR_OTHER||Proportion difference|27.7|||<|0.001|TWO_SIDED|90.0|19.6|35.8|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||35.8|19.6|<0.001
73912160|NCT00758836|147354670|SUPERIORITY_OR_OTHER||Proportion difference|20.4|||<|0.001|TWO_SIDED|90.0|12.6|28.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||28.2|12.6|<0.001
73912161|NCT00758836|147354670|SUPERIORITY_OR_OTHER||Proportion differenece|4.2||||0.449|TWO_SIDED|90.0|-5.0|13.3|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||13.3|-5.0|0.449
73912162|NCT00758836|147354670|SUPERIORITY_OR_OTHER||Proportion difference|7.7||||0.182|TWO_SIDED|90.0|-1.8|17.1|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||17.1|-1.8|0.182
73912163|NCT00758836|147354671|SUPERIORITY_OR_OTHER||Proportion difference|40.8|||<|0.001|TWO_SIDED|90.0|31.9|49.0|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||49.0|31.9|<0.001
73912164|NCT00758836|147354671|SUPERIORITY_OR_OTHER||Proportion difference|39.9|||<|0.001|TWO_SIDED|90.0|30.5|48.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||48.5|30.5|<0.001
73912165|NCT00758836|147354671|SUPERIORITY_OR_OTHER||Proportion difference|6.1||||0.265|TWO_SIDED|90.0|-2.9|14.9|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||14.9|-2.9|0.265
73912166|NCT00758836|147354671|SUPERIORITY_OR_OTHER||Proportion difference|5.2||||0.362|TWO_SIDED|90.0|-4.2|14.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||14.5|-4.2|0.362
73912167|NCT00758836|147354671|SUPERIORITY_OR_OTHER||Proportion difference|34.7|||<|0.001|TWO_SIDED|90.0|25.3|43.4|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||43.4|25.3|<0.001
73912168|NCT01817530|147354674|SUPERIORITY||Odds Ratio (OR)|32.51|||<|0.001|TWO_SIDED|95.0|11.12|95.05||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||95.05|11.12|< 0.001
73912169|NCT01817530|147354674|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
74026720|NCT01287117|147607057|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.44||||0.0017|TWO_SIDED|95.0|-5.57|-1.32||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.32|-5.57|0.0017
73912170|NCT01817530|147354674|SUPERIORITY||Odds Ratio (OR)|16.66|||<|0.001|TWO_SIDED|95.0|6.72|41.3||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||41.3|6.72|< 0.001
73912171|NCT01817530|147354674|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912172|NCT01817530|147354674|SUPERIORITY||Odds Ratio (OR)|11.13|||<|0.001|TWO_SIDED|95.0|4.79|25.84||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||25.84|4.79|< 0.001
73912173|NCT01817530|147354674|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912174|NCT01817530|147354674|SUPERIORITY||Odds Ratio (OR)|19.62|||<|0.001|TWO_SIDED|95.0|7.81|49.27||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||49.27|7.81|< 0.001
73912175|NCT01817530|147354674|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912176|NCT01817530|147354674|SUPERIORITY||Odds Ratio (OR)|6.02|||<|0.001|TWO_SIDED|95.0|2.95|12.3||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||12.3|2.95|< 0.001
73912177|NCT01817530|147354674|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912178|NCT01817530|147354674|SUPERIORITY||Odds Ratio (OR)|10.34|||<|0.001|TWO_SIDED|95.0|4.79|22.34||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||22.34|4.79|< 0.001
73912179|NCT01817530|147354674|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912180|NCT01817530|147354675|SUPERIORITY||Odds Ratio (OR)|156.17|||<|0.001|TWO_SIDED|95.0|38.04|641.22||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||641.22|38.04|< 0.001
73912181|NCT01817530|147354675|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912182|NCT01817530|147354675|SUPERIORITY||Odds Ratio (OR)|66.07|||<|0.001|TWO_SIDED|95.0|21.1|206.88||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||206.88|21.1|< 0.001
73965206|NCT03363854|147465440|SUPERIORITY||Difference|0.6||||0.04|TWO_SIDED|95.0|0.0|1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7 are reported below.||1.2|0.0|0.040
73912183|NCT01817530|147354675|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912184|NCT01817530|147354675|SUPERIORITY||Odds Ratio (OR)|52.15|||<|0.001|TWO_SIDED|95.0|17.42|156.09||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||156.09|17.42|< 0.001
73912185|NCT01817530|147354675|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912186|NCT01817530|147354675|SUPERIORITY||Odds Ratio (OR)|25.45|||<|0.001|TWO_SIDED|95.0|10.45|61.96||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||61.96|10.45|< 0.001
73912187|NCT01817530|147354675|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912188|NCT01817530|147354675|SUPERIORITY||Odds Ratio (OR)|9.65|||<|0.001|TWO_SIDED|95.0|4.38|21.25||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||21.25|4.38|< 0.001
73912189|NCT01817530|147354675|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912190|NCT01817530|147354675|SUPERIORITY||Odds Ratio (OR)|16.17|||<|0.001|TWO_SIDED|95.0|7.13|36.67||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||36.67|7.13|< 0.001
73912191|NCT01817530|147354675|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912192|NCT01817530|147354676|SUPERIORITY||Odds Ratio (OR)|123.14|||<|0.001|TWO_SIDED|95.0|25.93|584.85||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||584.85|25.93|< 0.001
73912193|NCT01817530|147354676|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912194|NCT01817530|147354676|SUPERIORITY||Odds Ratio (OR)|40.56|||<|0.001|TWO_SIDED|95.0|13.59|121.03||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||121.03|13.59|< 0.001
73912195|NCT01817530|147354676|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73965207|NCT03363854|147465440|SUPERIORITY||Difference|0.3||||0.31|TWO_SIDED|95.0|-0.3|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 8 are reported below.||1.0|-0.3|0.31
73912196|NCT01817530|147354676|SUPERIORITY||Odds Ratio (OR)|19.01|||<|0.001|TWO_SIDED|95.0|7.44|48.58||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||48.58|7.44|< 0.001
73912197|NCT01817530|147354676|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73965208|NCT03363854|147465440|SUPERIORITY||Difference|1.0||||0.001|TWO_SIDED|95.0|0.4|1.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9 are reported below.||1.6|0.4|0.001
73965209|NCT03363854|147465440|SUPERIORITY||Difference|0.7||||0.026|TWO_SIDED|95.0|0.1|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 10 are reported below.||1.3|0.1|0.026
73965210|NCT03363854|147465440|SUPERIORITY||Difference|0.9||||0.006|TWO_SIDED|95.0|0.2|1.5||The statistical test was not controlled for multiplicity.|Repeated measurements model]|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11 are reported below.||1.5|0.2|0.006
73965211|NCT03363854|147465440|SUPERIORITY||Difference|0.6||||0.043|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 12 are reported below.||1.3|0.0|0.043
73965212|NCT03363854|147465440|SUPERIORITY||Difference|0.8||||0.01|TWO_SIDED|95.0|0.2|1.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13 are reported below.||1.4|0.2|0.010
73912198|NCT01817530|147354676|SUPERIORITY||Odds Ratio (OR)|22.77|||<|0.001|TWO_SIDED|95.0|9.29|55.77||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||55.77|9.29|< 0.001
73965213|NCT03363854|147465440|SUPERIORITY||Difference|0.7||||0.037|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 14 are reported below.||1.3|0.0|0.037
73912199|NCT01817530|147354676|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912200|NCT01817530|147354676|SUPERIORITY||Odds Ratio (OR)|10.89|||<|0.001|TWO_SIDED|95.0|4.88|24.27||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||24.27|4.88|< 0.001
73912201|NCT01817530|147354676|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912202|NCT01817530|147354676|SUPERIORITY||Odds Ratio (OR)|9.72|||<|0.001|TWO_SIDED|95.0|4.46|21.22||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||21.22|4.46|< 0.001
73912203|NCT01817530|147354676|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912204|NCT01817530|147354677|SUPERIORITY||Odds Ratio (OR)|24.73|||<|0.001|TWO_SIDED|95.0|8.57|71.32||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||71.32|8.57|< 0.001
73912205|NCT01817530|147354677|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912206|NCT01817530|147354677|SUPERIORITY||Odds Ratio (OR)|17.21|||<|0.001|TWO_SIDED|95.0|6.57|45.05||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||45.05|6.57|< 0.001
73965214|NCT03363854|147465440|SUPERIORITY||Difference|0.6||||0.045|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15 are reported below.||1.3|0.0|0.045
73965215|NCT03363854|147465440|SUPERIORITY||Difference|0.5||||0.17|TWO_SIDED|95.0|-0.2|1.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 16 are reported below.||1.1|-0.2|0.17
73965216|NCT03363854|147465441|SUPERIORITY||Risk Difference (RD)|21.3|||<|0.001|TWO_SIDED|95.0|11.3|31.3||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.||31.3|11.3|<0.001
73965217|NCT03363854|147465442|SUPERIORITY||Risk Difference (RD)|11.4||||0.022|TWO_SIDED|95.0|2.1|20.7||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.||20.7|2.1|0.022
73965218|NCT03363854|147465443|SUPERIORITY||Difference|-5.4|||<|0.001|TWO_SIDED|95.0|-7.7|-3.1||The statistical test was not controlled for multiplicity.|Repeated measurement model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-3.1|-7.7|<0.001
73912207|NCT01817530|147354677|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912208|NCT01817530|147354677|SUPERIORITY||Odds Ratio (OR)|8.69|||<|0.001|TWO_SIDED|95.0|3.79|19.92||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||19.92|3.79|< 0.001
73912209|NCT01817530|147354677|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912210|NCT01817530|147354677|SUPERIORITY||Odds Ratio (OR)|18.67|||<|0.001|TWO_SIDED|95.0|7.11|49.02||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||49.02|7.11|< 0.001
73912211|NCT01817530|147354677|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
74085454|NCT01396421|147724962|SUPERIORITY_OR_OTHER||Treatment difference|-7.64||||0.0006|TWO_SIDED|95.0|-12.0|-3.3|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||-3.30|-12.0|0.0006
74085455|NCT01396421|147724962|SUPERIORITY_OR_OTHER||Traetment difference|-8.72|||<|0.0001|TWO_SIDED|95.0|-13.1|-4.37|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||-4.37|-13.1|<0.0001
74085456|NCT01396421|147724962|SUPERIORITY_OR_OTHER||Treatment difference|-2.89||||0.291|TWO_SIDED|95.0|-8.27|2.49|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||2.49|-8.27|0.2910
74085457|NCT01396421|147724963|SUPERIORITY_OR_OTHER||Treatment difference|-0.36||||0.0006|TWO_SIDED|95.0|-0.56|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between the average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed at a significance level of 0.05.||-0.15|-0.56|0.0006
73858235|NCT00642174|147261916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.2|||<|0.0001||95.0|-21.15|-11.33||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-11.33|-21.15|<0.0001
73858236|NCT00642174|147261916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.9|||<|0.0001||95.0|-29.67|-18.11||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-18.11|-29.67|<0.0001
73858237|NCT00642174|147261916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.9|||<|0.0001||95.0|-24.97|-14.9||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-14.90|-24.97|<0.0001
73912212|NCT01817530|147354677|SUPERIORITY||Odds Ratio (OR)|4.94|||<|0.001|TWO_SIDED|95.0|2.43|10.04||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||10.04|2.43|< 0.001
73912213|NCT01817530|147354677|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
74085458|NCT01396421|147724963|SUPERIORITY_OR_OTHER||Treatment difference|-0.38||||0.0012|TWO_SIDED|95.0|-0.61|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||-0.15|-0.61|0.0012
74085459|NCT01396421|147724963|SUPERIORITY_OR_OTHER||Treatment difference|-0.33||||0.0056|TWO_SIDED|95.0|-0.56|-0.1|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||-0.10|-0.56|0.0056
74085460|NCT01396421|147724963|SUPERIORITY_OR_OTHER||Treatment difference|-0.03||||0.8491|TWO_SIDED|95.0|-0.31|0.26|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||0.26|-0.31|0.8491
74085461|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|-1.5||||0.0644|TWO_SIDED|95.0|-3.09|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, and baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.09|-3.09|0.0644
73912214|NCT01817530|147354677|SUPERIORITY||Odds Ratio (OR)|11.76|||<|0.001|TWO_SIDED|95.0|5.17|26.79|||Regression, Logistic|P value is from a logistic regression model including treatment as the main effect and baseline value as a covariate.||||26.79|5.17|< 0.001
73912215|NCT01817530|147354677|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912216|NCT01817530|147354678|SUPERIORITY||Odds Ratio (OR)|31.48|||<|0.001|TWO_SIDED|95.0|10.02|98.83||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||98.83|10.02|< 0.001
73912217|NCT01817530|147354678|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73858238|NCT00642174|147261916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.3725||95.0|-8.46|3.26||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||3.26|-8.46|0.3725
73858239|NCT00896363|147261917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85|||||TWO_SIDED|90.0|-1.62|3.32|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 14||3.32|-1.62|
73858240|NCT00896363|147261917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|||||TWO_SIDED|90.0|-2.12|2.78|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 14||2.78|-2.12|
73858241|NCT00896363|147261917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.57|||||TWO_SIDED|90.0|-2.01|5.14|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 42||5.14|-2.01|
73912218|NCT01817530|147354678|SUPERIORITY||Odds Ratio (OR)|14.39|||<|0.001|TWO_SIDED|95.0|5.77|35.91||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||35.91|5.77|< 0.001
73912219|NCT01817530|147354678|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912220|NCT01817530|147354678|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.001|TWO_SIDED|95.0|4.23|22.8||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||22.8|4.23|< 0.001
73912221|NCT01817530|147354678|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912222|NCT01817530|147354678|SUPERIORITY||Odds Ratio (OR)|16.58|||<|0.001|TWO_SIDED|95.0|6.66|41.26||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||41.26|6.66|< 0.001
73912223|NCT01817530|147354678|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912224|NCT01817530|147354678|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|3.36|14.68||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||14.68|3.36|< 0.001
73912225|NCT01817530|147354678|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912226|NCT01817530|147354678|SUPERIORITY||Odds Ratio (OR)|10.73|||<|0.001|TWO_SIDED|95.0|4.85|23.76||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||23.76|4.85|< 0.001
73912227|NCT01817530|147354678|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
73912228|NCT01817530|147354679|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73912229|NCT01817530|147354679|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
74085462|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|-1.99||||0.0139|TWO_SIDED|95.0|-3.58|-0.41||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||-0.41|-3.58|0.0139
73912230|NCT01817530|147354679|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73912231|NCT01817530|147354679|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73912232|NCT01817530|147354679|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73912233|NCT01817530|147354679|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73912234|NCT01817530|147354680|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73912235|NCT01817530|147354680|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73912236|NCT01817530|147354680|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73912237|NCT01817530|147354680|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73858242|NCT00896363|147261917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|||||TWO_SIDED|90.0|-1.81|5.13|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 42||5.13|-1.81|
73858243|NCT00896363|147261918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31|||||TWO_SIDED|90.0|-0.93|1.56|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 14||1.56|-0.93|
73912238|NCT01817530|147354680|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73912239|NCT01817530|147354680|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73912240|NCT01817530|147354681|SUPERIORITY||difference in LS mean change|-3.7|STANDARD_ERROR_OF_MEAN|1.32||0.007|TWO_SIDED|95.0|-6.28|-1.03||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-1.03|-6.28|0.007
73912241|NCT01817530|147354681|SUPERIORITY||difference in LS mean change|-1.5|STANDARD_ERROR_OF_MEAN|0.98||0.132|TWO_SIDED|95.0|-3.44|0.46||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.46|-3.44|0.132
73912242|NCT01817530|147354681|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.94||0.876|TWO_SIDED|95.0|-1.71|2.0||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||2.00|-1.71|0.876
73912243|NCT01817530|147354681|SUPERIORITY||difference in LS mean change|-1.9|STANDARD_ERROR_OF_MEAN|1.0||0.055|TWO_SIDED|95.0|-3.92|0.04||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.04|-3.92|0.055
73912244|NCT01817530|147354681|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.82||0.898|TWO_SIDED|95.0|-1.52|1.74||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.74|-1.52|0.898
73912245|NCT01817530|147354681|SUPERIORITY||difference in LS mean change|-0.4|STANDARD_ERROR_OF_MEAN|0.81||0.59|TWO_SIDED|95.0|-2.05|1.17||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.17|-2.05|0.59
73912246|NCT01817530|147354682|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.31||0.001|TWO_SIDED|95.0|-1.64|-0.42||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.42|-1.64|0.001
73912247|NCT01817530|147354682|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.42|-0.48||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.48|-1.42|< 0.001
73912248|NCT01817530|147354682|SUPERIORITY||difference in LS mean change|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.002|TWO_SIDED|95.0|-1.12|-0.25||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.25|-1.12|0.002
73912249|NCT01817530|147354682|SUPERIORITY||difference in LS mean change|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.118|TWO_SIDED|95.0|-1.04|0.12||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.12|-1.04|0.118
73912250|NCT01817530|147354682|SUPERIORITY||difference in LS mean change|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.22|-1.16|0.004
73912251|NCT01817530|147354682|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.51|-0.59||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.59|-1.51|< 0.001
73912252|NCT01817530|147354683|SUPERIORITY||difference in LS mean change|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.79|-0.15||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||-0.15|-0.79|0.004
73912253|NCT01817530|147354683|SUPERIORITY||difference in LS mean change|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.314|TWO_SIDED|95.0|-0.4|0.13||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.13|-0.4|0.314
73912254|NCT01817530|147354683|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.307|TWO_SIDED|95.0|-0.12|0.39||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.39|-0.12|0.307
73912255|NCT01817530|147354683|SUPERIORITY||difference in LS mean change|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.106|TWO_SIDED|95.0|-0.58|0.06||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.06|-0.58|0.106
73912256|NCT01817530|147354683|SUPERIORITY||difference in LS mean change|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.424|TWO_SIDED|95.0|-0.36|0.15||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.15|-0.36|0.424
74085463|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|0.35||||0.7231|TWO_SIDED|95.0|-1.61|2.32||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||2.32|-1.61|0.7231
74085464|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|-5.14||||0.0018|TWO_SIDED|95.0|-8.36|-1.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-1.93|-8.36|0.0018
74085465|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|-3.75||||0.0045|TWO_SIDED|95.0|-6.33|-1.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 2||||-1.17|-6.33|0.0045
73912257|NCT01817530|147354683|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.528|TWO_SIDED|95.0|-0.18|0.35||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.35|-0.18|0.528
73912258|NCT01817530|147354684|SUPERIORITY||difference in LS means|1.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.8|1.74||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.74|0.80|< 0.001
73912259|NCT01817530|147354684|SUPERIORITY||difference in LS means|1.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.78|1.72||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.72|0.78|< 0.001
73912260|NCT01817530|147354684|SUPERIORITY||difference in LS means|0.8|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.33|1.27||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.27|0.33|< 0.001
73912261|NCT01817530|147354684|SUPERIORITY||difference in LS means|1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.65|1.52||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.52|0.65|< 0.001
73912262|NCT01817530|147354684|SUPERIORITY||difference in LS means|0.7|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.29|1.16||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.16|0.29|< 0.001
73912263|NCT01817530|147354684|SUPERIORITY||difference in LS means|0.8|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.4|1.26||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.26|0.4|< 0.001
73912264|NCT01817530|147354685|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912265|NCT01817530|147354685|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912266|NCT01817530|147354685|SUPERIORITY|||||||0.018||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.018
73912267|NCT01817530|147354685|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912268|NCT01817530|147354685|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912269|NCT01817530|147354685|SUPERIORITY|||||||0.021||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.021
73912270|NCT01817530|147354685|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
73965219|NCT03363854|147465444|SUPERIORITY||Risk Difference (RD)|22.9|||<|0.001|TWO_SIDED|95.0|12.4|33.3||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Partcipants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.||33.3|12.4|<0.001
73912271|NCT01817530|147354685|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
73912272|NCT01817530|147354685|SUPERIORITY|||||||0.032||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.032
73912273|NCT01817530|147354685|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
73912274|NCT01817530|147354685|SUPERIORITY|||||||0.007||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.007
73912275|NCT01817530|147354685|SUPERIORITY|||||||0.495||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.495
73912276|NCT01817530|147354685|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
74085466|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|1.84||||0.2568|TWO_SIDED|95.0|-1.34|5.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||5.02|-1.34|0.2568
73912277|NCT01817530|147354685|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
73912278|NCT01817530|147354685|SUPERIORITY|||||||0.015||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.015
74085467|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|-4.4||||0.0009|TWO_SIDED|95.0|-6.97|-1.82||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||-1.82|-6.97|0.0009
73912279|NCT01817530|147354685|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
73912280|NCT01817530|147354685|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.002
73912281|NCT01817530|147354685|SUPERIORITY|||||||0.329||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.329
73912282|NCT01817530|147354686|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912283|NCT01817530|147354686|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
74085468|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|-3.45||||0.036|TWO_SIDED|95.0|-6.67|-0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-0.23|-6.67|0.0360
73912284|NCT01817530|147354686|SUPERIORITY|||||||0.036||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.036
73912285|NCT01817530|147354686|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912286|NCT01817530|147354686|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912287|NCT01817530|147354686|SUPERIORITY|||||||0.04||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||||||0.040
73912288|NCT01817530|147354686|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
73912289|NCT01817530|147354686|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||||||< 0.001
73912290|NCT01817530|147354686|SUPERIORITY|||||||0.098||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.098
73912291|NCT01817530|147354686|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
73912292|NCT01817530|147354686|SUPERIORITY|||||||0.014||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.014
73912293|NCT01817530|147354686|SUPERIORITY|||||||0.409||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.409
73912294|NCT01817530|147354686|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
73912295|NCT01817530|147354686|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
73912296|NCT01817530|147354686|SUPERIORITY|||||||0.094||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.094
73912297|NCT01817530|147354686|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
73912298|NCT01817530|147354686|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.002
73912299|NCT01817530|147354686|SUPERIORITY|||||||0.393||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.393
73912300|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912301|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912302|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912303|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912304|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
73912305|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
74085469|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.9876|TWO_SIDED|95.0|-4.53|4.6||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||4.60|-4.53|0.9876
73912306|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
73912307|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
73912308|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
73912309|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
73912310|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
73912311|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
73912312|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
73912313|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
73965220|NCT03363854|147465445|SUPERIORITY||Risk Difference (RD)|11.1||||0.012|TWO_SIDED|95.0|3.2|19.0||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.||19.0|3.2|0.012
73965221|NCT03363854|147465446|SUPERIORITY||Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.7|-0.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-0.7|-1.7|<0.001
74085470|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|-7.61|||<|0.0001|TWO_SIDED|95.0|-11.3|-3.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||-3.93|-11.3|<0.0001
74085471|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|-5.16||||0.0062|TWO_SIDED|95.0|-8.85|-1.47||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 4||||-1.47|-8.85|0.0062
73912314|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
73912315|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
73912316|NCT01817530|147354687|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
73912317|NCT01817530|147354688|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
73912318|NCT01817530|147354688|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
73912319|NCT01817530|147354688|SUPERIORITY|||||||0.02||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.020
73912320|NCT01817530|147354688|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
73912321|NCT01817530|147354688|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.002
73912322|NCT01817530|147354688|SUPERIORITY|||||||0.061||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.061
73912323|NCT01817530|147354688|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
73912324|NCT01817530|147354688|SUPERIORITY|||||||0.004||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.004
73912325|NCT01817530|147354688|SUPERIORITY|||||||0.085||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.085
73965222|NCT03363854|147465447|SUPERIORITY||Risk Difference (RD)|17.6|||<|0.001|TWO_SIDED|95.0|8.0|27.1||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their DLQI value at Week 16.||27.1|8.0|<0.001
73912326|NCT01817530|147354688|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
73912327|NCT01817530|147354688|SUPERIORITY|||||||0.012||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.012
73912328|NCT01817530|147354688|SUPERIORITY|||||||0.049||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.049
73912329|NCT01817530|147354688|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
73912330|NCT01817530|147354688|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
73912331|NCT01817530|147354688|SUPERIORITY|||||||0.056||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.056
73912332|NCT01817530|147354688|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
74026721|NCT01287117|147607057|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.93|||<|0.0001|TWO_SIDED|95.0|-9.1|-4.76||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.76|-9.10|<0.0001
74085472|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|1.93||||0.3407|TWO_SIDED|95.0|-2.05|5.9||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||5.90|-2.05|0.3407
74085473|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|-7.86||||0.0001|TWO_SIDED|95.0|-11.9|-3.86||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 5||||-3.86|-11.9|0.0001
74085474|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|-7.15||||0.0005|TWO_SIDED|95.0|-11.2|-3.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-3.14|-11.2|0.0005
73912333|NCT01817530|147354688|SUPERIORITY|||||||0.005||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.005
73912334|NCT01817530|147354688|SUPERIORITY|||||||0.088||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.088
73912335|NCT01817530|147354689|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
73912336|NCT01817530|147354689|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
73912337|NCT01817530|147354689|SUPERIORITY|||||||0.188||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.188
73912338|NCT01817530|147354689|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
73912339|NCT01817530|147354689|SUPERIORITY|||||||0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.001
73912340|NCT01817530|147354689|SUPERIORITY|||||||0.104||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.104
73912341|NCT01817530|147354689|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
73912342|NCT01817530|147354689|SUPERIORITY|||||||0.021||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.021
73912343|NCT01817530|147354689|SUPERIORITY|||||||0.859||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.859
73912344|NCT01817530|147354689|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
73912345|NCT01817530|147354689|SUPERIORITY|||||||0.006||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.006
73912346|NCT01817530|147354689|SUPERIORITY|||||||0.015||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.015
73912347|NCT01817530|147354689|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
73912348|NCT01817530|147354689|SUPERIORITY|||||||0.007||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.007
73912349|NCT01817530|147354689|SUPERIORITY|||||||0.722||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.722
73912350|NCT01817530|147354689|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
73912351|NCT01817530|147354689|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
73912352|NCT01817530|147354689|SUPERIORITY|||||||0.032||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.032
73912353|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
73912354|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
73912355|NCT01817530|147354690|SUPERIORITY|||||||0.041||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.041
73912356|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
73912357|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
74085475|NCT01396421|147724964|SUPERIORITY_OR_OTHER||Treatment difference|-1.12||||0.657|TWO_SIDED|95.0|-6.07|3.83||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5|Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.|||3.83|-6.07|0.6570
73912358|NCT01817530|147354690|SUPERIORITY|||||||0.008||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.008
73912359|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
73912360|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
73912361|NCT01817530|147354690|SUPERIORITY|||||||0.003||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.003
73912362|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
73912363|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
73912364|NCT01817530|147354690|SUPERIORITY|||||||0.003||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.003
73912365|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
73912366|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
73912367|NCT01817530|147354690|SUPERIORITY|||||||0.004||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.004
73912368|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
73912369|NCT01817530|147354690|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
73912370|NCT01817530|147354690|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.002
73912371|NCT01817530|147354691|SUPERIORITY||difference in LS means|-1.5|STANDARD_ERROR_OF_MEAN|2.58||0.556|TWO_SIDED|95.0|-6.65|3.59||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||3.59|-6.65|0.556
73912372|NCT01817530|147354691|SUPERIORITY||difference in LS means|-1.1|STANDARD_ERROR_OF_MEAN|2.63||0.672|TWO_SIDED|95.0|-6.33|4.09||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||4.09|-6.33|0.672
73912373|NCT01817530|147354691|SUPERIORITY||difference in LS means|3.0|STANDARD_ERROR_OF_MEAN|2.71||0.274|TWO_SIDED|95.0|-2.39|8.36||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||8.36|-2.39|0.274
73912374|NCT01817530|147354691|SUPERIORITY||difference in LS means|-2.0|STANDARD_ERROR_OF_MEAN|1.65||0.223|TWO_SIDED|95.0|-5.26|1.23||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.23|-5.26|0.223
73912375|NCT01817530|147354691|SUPERIORITY||difference in LS means|-2.1|STANDARD_ERROR_OF_MEAN|1.68||0.215|TWO_SIDED|95.0|-5.38|1.22||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.22|-5.38|0.215
73858244|NCT00896363|147261918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|||||TWO_SIDED|90.0|-0.73|1.75|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 14||1.75|-0.73|
73858245|NCT00896363|147261918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|||||TWO_SIDED|90.0|-1.1|2.42|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 42||2.42|-1.10|
73858246|NCT00896363|147261918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|||||TWO_SIDED|90.0|-0.93|2.48|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 42||2.48|-0.93|
73858247|NCT00896363|147261919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|||||TWO_SIDED|90.0|-0.94|2.37|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 14||2.37|-0.94|
73858248|NCT00896363|147261919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44|||||TWO_SIDED|90.0|-2.1|1.21|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 14||1.21|-2.10|
73858249|NCT00896363|147261919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84|||||TWO_SIDED|90.0|-1.22|2.9|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 42||2.90|-1.22|
73858250|NCT00896363|147261919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81|||||TWO_SIDED|90.0|-1.22|2.85|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 42||2.85|-1.22|
73858251|NCT03002818|147261969|SUPERIORITY||mean change|-108266.0||||0.091|TWO_SIDED|95.0|-235037.0|18504.0|||one-sample t-test|||sdITT (n=26): Change at Day 168 minus Baseline||18504|-235037|0.091
73858252|NCT03002818|147261969|SUPERIORITY||mean change|-98373.0||||0.152|TWO_SIDED|95.0|-235667.0|38921.0|||one-sample t-test|||mITT (n=24): Change at Day 168 minus Baseline||38921|-235667|0.152
73858253|NCT03002818|147261969|SUPERIORITY|||||||0.091|||||||paired t-test|||sdITT (n=26): Baseline vs. Day 168||||0.091
74085476|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Treatment difference|-0.02||||0.6553|TWO_SIDED|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.08|-0.13|0.6553
73858254|NCT03002818|147261969|SUPERIORITY|||||||0.152|||||||paired t-test|||mITT (n=24): Baseline vs. Day 168||||0.152
73858255|NCT03002818|147261970|SUPERIORITY|||||||0.461|||||||paired t-test|||sdITT (n=34): Baseline vs. Day 28||||0.461
73858256|NCT03002818|147261970|SUPERIORITY|||||||0.63|||||||paired t-test|||mITT (n=24): Baseline vs. Day 28||||0.630
73858257|NCT03002818|147261970|SUPERIORITY|||||||0.855|||||||paired t-test|||sdITT (n=32): Baseline vs. Day 84||||0.855
73858258|NCT03002818|147261970|SUPERIORITY|||||||0.75|||||||paired t-test|||mITT (n=24): Baseline vs. Day 84||||0.750
73858259|NCT03002818|147261971|SUPERIORITY||mean change|2.6|||||TWO_SIDED|95.0|2.063|3.137||||||sdITT: mean change Baseline minus Day 168||3.137|2.063|
73858260|NCT03002818|147261971|SUPERIORITY||mean change|2.82|||||TWO_SIDED|95.0|2.212|3.428||||||mITT: mean change Baseline minus Day 168||3.428|2.212|
73858261|NCT03002818|147261971|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168||||<0.001
73858262|NCT03002818|147261971|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168||||<0.001
73858263|NCT03002818|147261971|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28||||<0.001
73858264|NCT03002818|147261971|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28||||<0.001
73858265|NCT03002818|147261971|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84||||<0.001
73858266|NCT03002818|147261971|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=23): Baseline vs. Day 84||||<0.001
73858267|NCT03002818|147261972|SUPERIORITY||mean change|0.61|||||TWO_SIDED|95.0|-0.651|1.871||||||sdITT: mean change Baseline minus Day 168||1.871|-0.651|
73858268|NCT03002818|147261972|SUPERIORITY||mean change|0.74|||||TWO_SIDED|95.0|-0.608|2.088||||||mITT: mean change Baseline minus Day 168||2.088|-0.608|
73858269|NCT03002818|147261972|SUPERIORITY|||||||0.381|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168||||0.381
73912376|NCT01817530|147354691|SUPERIORITY||difference in LS means|-1.4|STANDARD_ERROR_OF_MEAN|1.68||0.392|TWO_SIDED|95.0|-4.75|1.87||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.87|-4.75|0.392
73912377|NCT00594659|147354699|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||accelerated bootstrapping|||Pairwise comparison; non-parametric tests performed because of non-normal distribution||||<0.05
73912378|NCT00594659|147354699|SUPERIORITY_OR_OTHER||||||<|0.05|||||||accelerated bootstrapping|||pairwise comparison; non-parametric analysis||||< .05
73912379|NCT00594659|147354699|SUPERIORITY_OR_OTHER||||||>|0.05|||||||accelerated bootstrapping|||nonparametric pairwise comparison; non-normal distribution||||> 0.05
73912380|NCT00594659|147354700|SUPERIORITY_OR_OTHER||Slope|3.11|STANDARD_ERROR_OF_MEAN|0.69|<|0.05|TWO_SIDED||||||piecewise mixed model with logit link an|Performed across all assessments.|Slope and p-value above are for group 1: baseline to ETX. Group 3 vs. Group 1 baseline to ETX slope, p \< 0.05. All other pairwise comparisons p \> 0.05.|pairwise comparisons among groups across 4 follow-up timepoints||||< 0.05
73912381|NCT04560998|147354745|SUPERIORITY||The Hodges-Lehmann estimate|1.13||||0.0004|TWO_SIDED|95.0|1.056|1.211|||Wilcoxon (Mann-Whitney)|||||1.211|1.056|0.0004
73912382|NCT04560998|147354746|SUPERIORITY||The Hodges-Lehmann estimate|1.08||||0.038|TWO_SIDED|95.0|1.004|1.156|||Wilcoxon (Mann-Whitney)|||||1.156|1.004|0.0380
74085477|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Treatment difference|-0.03||||0.617|TWO_SIDED|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.08|-0.13|0.6170
73912383|NCT04560998|147354747|SUPERIORITY||The Hodges-Lehmann estimate|1.0||||0.0108|TWO_SIDED|95.0|0.478|1.518|||Wilcoxon (Mann-Whitney)|||||1.518|0.478|0.0108
73912384|NCT04560998|147354748|SUPERIORITY||The Hodges-Lehmann Estimate|1.11||||0.0046|TWO_SIDED|95.0|1.033|1.197|||Wilcoxon (Mann-Whitney)|||||1.197|1.033|0.0046
73912385|NCT03281577|147354767|SUPERIORITY||Least Squares Mean Differences|-25.81||||0.0012|TWO_SIDED|95.0|-41.757|-9.858||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% confidence interval (CI) are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as covariate.|||-9.858|-41.757|0.0012
73912386|NCT03281577|147354767|SUPERIORITY||Least Squares Mean Differences|-27.52||||0.0018|TWO_SIDED|95.0|-45.224|-9.813||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-9.813|-45.224|0.0018
73912387|NCT03281577|147354767|SUPERIORITY||Least Squares Mean Differences|-41.76|||<|0.0001|TWO_SIDED|95.0|-59.616|-23.902||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-23.902|-59.616|<.0001
73912388|NCT03281577|147354768|SUPERIORITY||Least Squares Mean Differences|0.72||||0.259|TWO_SIDED|95.0|-0.364|1.795||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||1.795|-0.364|0.2590
73912389|NCT03281577|147354768|SUPERIORITY||Least Squares Mean Differences|1.27||||0.028|TWO_SIDED|95.0|0.119|2.418||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||2.418|0.119|0.0280
73912390|NCT03281577|147354768|SUPERIORITY||Least Squares Mean Differences|0.45||||0.6882|TWO_SIDED|95.0|-0.757|1.66||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||1.660|-0.757|0.6882
73965223|NCT03050814|147465453|OTHER||Hazard Ratio (HR)|1.061||||0.91|TWO_SIDED|95.0|0.38|2.966|||Kaplan Meier|Kaplan-Meier curves and a two-tailed log-rank test||||2.966|0.380|0.91
74085478|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Treatment difference|0.03||||0.6446|TWO_SIDED|95.0|-0.1|0.15||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates..|Mixed Models Analysis|Week 1||||0.15|-0.10|0.6446
73912391|NCT03281577|147354768|SUPERIORITY||Least Squares Mean Differences|1.87||||0.0062|TWO_SIDED|95.0|0.493|3.25||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||3.250|0.493|0.0062
73912392|NCT03281577|147354768|SUPERIORITY||Least Squares Mean Differences|1.19||||0.149|TWO_SIDED|95.0|-0.327|2.717||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||2.717|-0.327|0.1490
73912393|NCT03281577|147354768|SUPERIORITY||Least Squares Mean Differences|0.63||||0.6285|TWO_SIDED|95.0|-0.931|2.2||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||2.200|-0.931|0.6285
73965224|NCT04059042|147465486|EQUIVALENCE|Between-session pain measures were assessed with related-samples Wilcoxon signed-rank tests (Audio minus Silence). Data were not normally distributed so nonparametric tests were used.|Z score|39.0||||0.0051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0051
73965225|NCT04059042|147465486|EQUIVALENCE|Between-session change scores were calculated per participant as Audio minus Silence and compared between groups with independent samples Mann-Whitney U-tests. Data were not normally distributed so nonparametric tests were used.|Z score|19.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
73858270|NCT03002818|147261972|SUPERIORITY|||||||0.304|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168||||0.304
73858271|NCT03002818|147261972|SUPERIORITY|||||||0.014|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28||||0.014
73858272|NCT03002818|147261972|SUPERIORITY|||||||0.278|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28||||0.278
73858273|NCT03002818|147261972|SUPERIORITY|||||||0.881|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84||||0.881
73858274|NCT03002818|147261972|SUPERIORITY|||||||0.775|||||||Paired Wilcoxon Test|||sdITT (n=23): Baseline vs. Day 84||||0.775
73858275|NCT00100230|147261985|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.3|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.30
73858276|NCT00100230|147261986|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.27
73858277|NCT00100230|147261986|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
73858278|NCT00100230|147261987|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||8e-06|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.000008
73858279|NCT01106859|147262045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.0174|TWO_SIDED|95.0|0.1|1.5||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups.||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 4 Hours) - LS mean of SDLP (Placebo).||1.5|0.1|0.0174
73858280|NCT01106859|147262045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||<|0.0001|TWO_SIDED|95.0|0.8|2.1||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 3 Hours) - LS mean of SDLP (Placebo).||2.1|0.8|<0.0001
73858281|NCT01106859|147262045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.8|3.1||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zopiclone) - LS mean of SDLP (Placebo).||3.1|1.8|<0.0001
73858282|NCT01106859|147262046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.0145|TWO_SIDED|95.0|0.03|0.27||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 4 hours prior) - LS mean of SDS (Placebo).||0.27|0.03|0.0145
73858283|NCT01106859|147262046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.2179|TWO_SIDED|95.0|-0.05|0.2||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 3 Hours) - LS mean of SDS (Placebo).||0.20|-0.05|0.2179
73858284|NCT01106859|147262046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.0096|TWO_SIDED|95.0|0.04|0.29||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zopiclone) - LS mean of SDS (Placebo).||0.29|0.04|0.0096
73858285|NCT01106859|147262049|SUPERIORITY_OR_OTHER|||||||0.2188||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.2188
73858286|NCT01106859|147262049|SUPERIORITY_OR_OTHER|||||||0.0117||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0117
73858287|NCT01106859|147262049|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||<0.0001
73912394|NCT03281577|147354768|SUPERIORITY||Least Squares Mean Differences|1.29||||0.0358|TWO_SIDED|95.0|0.073|2.501||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||2.501|0.073|0.0358
73858288|NCT01106859|147262051|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.1250
73858289|NCT01106859|147262051|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0074
73912395|NCT03281577|147354768|SUPERIORITY||Least Squares Mean Differences|1.33||||0.043|TWO_SIDED|95.0|0.035|2.621||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||2.621|0.035|0.0430
73858290|NCT01106859|147262051|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of Zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||<0.0001
73912396|NCT03281577|147354768|SUPERIORITY||Least Squares Mean Differences|0.25||||0.9419|TWO_SIDED|95.0|-1.107|1.611||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||1.611|-1.107|0.9419
73912397|NCT03281577|147354769|SUPERIORITY||Least Squares Mean Differences|33.12||||0.0436|TWO_SIDED|95.0|0.799|65.439||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||65.439|0.799|0.0436
73912398|NCT03281577|147354769|SUPERIORITY||Least Squares Mean Differences|57.98||||0.0007|TWO_SIDED|95.0|23.555|92.396||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||92.396|23.555|0.0007
73912399|NCT03281577|147354769|SUPERIORITY||Least Squares Mean Differences|44.44||||0.0134|TWO_SIDED|95.0|8.249|80.629||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||80.629|8.249|0.0134
73912400|NCT03281577|147354770|SUPERIORITY||Least Squares Mean Differences|-10.27||||0.0789|TWO_SIDED|95.0|-21.507|0.96||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||0.960|-21.507|0.0789
73912401|NCT03281577|147354770|SUPERIORITY||Least Squares Mean Differences|-13.28||||0.027|TWO_SIDED|95.0|-25.242|-1.314||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-1.314|-25.242|0.0270
73912402|NCT03281577|147354770|SUPERIORITY||Least Squares Mean Differences|-11.63||||0.075|TWO_SIDED|95.0|-24.206|0.952||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||0.952|-24.206|0.0750
73912403|NCT00926328|147354878|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74085479|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Treatment difference|-0.15||||0.0347|TWO_SIDED|95.0|-0.29|-0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||-0.01|-0.29|0.0347
73912404|NCT00926328|147354879|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73912405|NCT01227434|147354896|SUPERIORITY_OR_OTHER||Exact binomial distribution|0.1||||0.1|TWO_SIDED||||||Exact binomial distribution|||Compared to historical estimates of PFS-6 months. With 30 patients, there would be 90% power to detect an improvement in the PFS-6 months rate from 10% (historical estimate) to 30% based on a one-sided exact test with alpha=0.1.||||0.10
73912406|NCT01513343|147354898|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|Multinomial logistic regression examined program effects on child BMI categories, controlling for child sex, age (months), \& BMI z-score at pretest.||||||<0.05
73912407|NCT01513343|147354899|SUPERIORITY||||||<|0.05||||||To control for type I errors, the critical P values for each assessment were determined with the unweighted Bonferroni method, dividing the critical value of P \< 0.05 by the number of comparisons conducted for a given assessment.|Mixed Models Analysis|||||||<0.05
73858291|NCT01106859|147262053|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.5000
73858292|NCT01106859|147262053|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0156
73858293|NCT01106859|147262053|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0001
73858294|NCT01685801|147262069|SUPERIORITY_OR_OTHER||Posterior Mean|2.251|STANDARD_DEVIATION|0.961|||TWO_SIDED|95.0|0.383|4.144|||||The posterior distribution of overall treatment difference was obtained using the Bayesian hierarchical model and 95% credible interval of the treatment effect (posterior mean) was calculated.|"This statistical analysis is for Overall category."||4.144|0.383|
73858295|NCT04686084|147262076|OTHER|Bland-Altman analysis|Median Difference (Final Values)|0.04|||||TWO_SIDED|||||||||||||
73858296|NCT03552536|147262079|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. Least squares (LS) mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-0.6|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8583 and placebo at least 0.5 log10 copies/mL was 64%.|||||
73858297|NCT00957944|147262163|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0302||||||90.0|0.9693|1.0951|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0951|0.9693|
73858298|NCT00957944|147262164|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0571||||||90.0|0.9903|1.1284|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.1284|0.9903|
73858299|NCT00957944|147262165|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0289||||||90.0|0.9714|1.0899|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0899|0.9714|
73858300|NCT00522418|147262180|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||F Test|||||||.01
73858301|NCT00522418|147262183|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||F-Test|||||||0.17
73858302|NCT00522418|147262186|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||F-Test|||||||0.17
73858303|NCT00522418|147262187|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||F-Test|||||||0.28
73858304|NCT00522418|147262188|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||F-Test|||||||0.03
73858305|NCT00522418|147262189|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||F-Test|||||||0.26
73858306|NCT02139878|147262205|SUPERIORITY_OR_OTHER||||||=|0.088|||||||ANCOVA|||||||=0.088
73858307|NCT02139878|147262206|SUPERIORITY_OR_OTHER||||||=|0.98|||||||ANCOVA|||||||=0.980
73858308|NCT00737568|147262218|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value for the two-sided Cochran-Mantel-Haenszel test was controlled for strata (HBeAg status and ALT level).|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the FTC/TDF and TDF treatment groups. The alternative hypothesis is that there is a difference between the FTC/TDF and TDF treatment groups. These hypotheses were evaluated using a Cochran-Mantel-Haenszel (CMH) test, controlling for randomization strata, with the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint.||||0.43
73858309|NCT00855933|147262231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.066||0.126|TWO_SIDED|95.0|-0.03|0.24||a priori threshold for statistical significance = 0.05|ANCOVA||2-sided with the significance level set at 5%|||0.24|-0.03|0.126
73858310|NCT01960998|147262233|SUPERIORITY|||||||0.22||||||P value not adjusted for multiple comparisons|Log Rank||||Data were not collected beyond the 12-month follow up, at which point fewer than 50% of participants in both groups had achieved continence. Thus, their time to continence could not be determined and the medians could not be calculated.|||0.22
73912408|NCT01397890|147354902|SUPERIORITY_OR_OTHER||Ratio|1.044||||0.0004|TWO_SIDED|95.0|1.019|1.069|||ANCOVA|multiplicative ANCOVA model with treatment and country as fixed factors and baseline value as a (log-transformed) covariate||||1.069|1.019|0.0004
74085480|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Leasr squares mean|-0.12||||0.0825|TWO_SIDED|95.0|-0.27|0.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.02|-0.27|0.0825
74085481|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Treatment difference|0.12||||0.1678|TWO_SIDED|95.0|-0.05|0.3||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||0.30|-0.05|0.1678
74085482|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.0219|TWO_SIDED|95.0|-0.39|-0.03||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-0.03|-0.39|0.0219
74085483|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Least squares mean|-0.09||||0.3275|TWO_SIDED|95.0|-0.27|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||0.09|-0.27|0.3275
74085484|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.1173|TWO_SIDED|95.0|-0.04|0.4||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||0.40|-0.04|0.1173
74085485|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Treatment difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.21||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||-0.21|-0.63|<0.0001
74085486|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Least squares mean|-0.19||||0.0662|TWO_SIDED|95.0|-0.4|0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||0.01|-0.40|0.0662
74085487|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.7587|TWO_SIDED|95.0|-0.3|0.22||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||0.22|-0.30|0.7587
73912409|NCT01397890|147354903|SUPERIORITY_OR_OTHER||Ratio|1.079|||<|0.0001|TWO_SIDED|95.0|1.057|1.102|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.102|1.057|<0.0001
73912410|NCT01397890|147354904|SUPERIORITY_OR_OTHER||Ratio|1.086|||<|0.0001|TWO_SIDED|95.0|1.062|1.111|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.111|1.062|<0.0001
73912411|NCT01397890|147354905|SUPERIORITY_OR_OTHER||Ratio|1.018||||0.057|TWO_SIDED|95.0|0.999|1.037|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.037|0.999|0.0570
73912412|NCT01397890|147354906|SUPERIORITY_OR_OTHER||Ratio|1.05|||<|0.0001|TWO_SIDED|95.0|1.033|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.067|1.033|<0.0001
73912413|NCT01397890|147354907|SUPERIORITY_OR_OTHER||Ratio|1.054|||<|0.0001|TWO_SIDED|95.0|1.036|1.073|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.073|1.036|<0.0001
73912414|NCT01397890|147354908|SUPERIORITY_OR_OTHER||Ratio|1.02||||0.1956|TWO_SIDED|95.0|0.99|1.05|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.050|0.990|0.1956
73912415|NCT01397890|147354909|SUPERIORITY_OR_OTHER||Ratio|1.062|||<|0.0001|TWO_SIDED|95.0|1.035|1.091|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.091|1.035|<0.0001
74085488|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Treatment difference|-0.39||||0.0006|TWO_SIDED|95.0|-0.61|-0.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-0.17|-0.61|0.0006
74085489|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Least squares mean|-0.34||||0.0032|TWO_SIDED|95.0|-0.56|-0.11||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-0.11|-0.56|0.0032
74085490|NCT01396421|147724965|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.7619|TWO_SIDED|95.0|-0.32|0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||0.23|-0.32|0.7619
74085491|NCT01396421|147724966|SUPERIORITY_OR_OTHER||Treatment difference|2.46||||0.0557|TWO_SIDED|95.0|-0.06|4.98||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||4.98|-0.06|0.0557
74085492|NCT01396421|147724966|SUPERIORITY_OR_OTHER||Treatment difference|2.89||||0.025|TWO_SIDED|95.0|0.37|5.42||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||5.42|0.37|0.0250
74085493|NCT01396421|147724966|SUPERIORITY_OR_OTHER||Treatment difference|1.58||||0.3264|TWO_SIDED|95.0|-1.58|4.74||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||4.74|-1.58|0.3264
74085494|NCT01396421|147724967|SUPERIORITY_OR_OTHER||Treatment difference|-2.44||||0.001|TWO_SIDED|95.0|-3.88|-0.99||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.99|-3.88|0.0010
74085495|NCT01396421|147724967|SUPERIORITY_OR_OTHER||Treatment difference|-2.22||||0.0029|TWO_SIDED|95.0|-3.67|-0.77||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.77|-3.67|0.0029
74085496|NCT01396421|147724967|SUPERIORITY_OR_OTHER||Treatment difference|-1.11||||0.2227|TWO_SIDED|95.0|-2.9|0.68||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.68|-2.90|0.2227
73912416|NCT01397890|147354910|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.303||||0.0001|TWO_SIDED|95.0|9.904|30.702|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||30.702|9.904|0.0001
73912417|NCT01397890|147354911|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.587|||<|0.0001|TWO_SIDED|95.0|7.407|19.766|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||19.766|7.407|<0.0001
73912418|NCT01397890|147354912|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.469|||<|0.0001|TWO_SIDED|95.0|10.147|24.791|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||24.791|10.147|<0.0001
73912419|NCT01397890|147354913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.428||||0.0001|TWO_SIDED|95.0|13.463|39.393|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||39.393|13.463|0.0001
73912420|NCT01397890|147354914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.192||||0.0006|TWO_SIDED|95.0|7.491|26.894|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||26.894|7.491|0.0006
73912421|NCT01397890|147354915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.472|||<|0.0001|TWO_SIDED|95.0|10.347|26.596|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||26.596|10.347|<0.0001
73912422|NCT01397890|147354916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.668|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.437|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.437|-0.900|<0.0001
73912423|NCT01397890|147354917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.375|||<|0.0001|TWO_SIDED|95.0|-0.552|-0.198|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.198|-0.552|<0.0001
73912424|NCT01397890|147354918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.551|||<|0.0001|TWO_SIDED|95.0|-0.741|-0.361|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.361|-0.741|<0.0001
73912425|NCT01397890|147354919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.236||||0.0028|TWO_SIDED|95.0|-0.391|-0.082|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.082|-0.391|0.0028
73912426|NCT01397890|147354920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.0372|TWO_SIDED|95.0|-0.24|-0.007|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.007|-0.240|0.0372
73912427|NCT01397890|147354921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.0001|TWO_SIDED|95.0|-0.35|-0.113|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.113|-0.350|0.0001
73912428|NCT01397890|147354922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262|||<|0.0001|TWO_SIDED|95.0|-0.364|-0.159|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.159|-0.364|<0.0001
74085497|NCT01396421|147724968|SUPERIORITY_OR_OTHER||Treatment difference|-1.41||||0.0069|TWO_SIDED|95.0|-2.44|0.39||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.39|-2.44|0.0069
73912429|NCT01397890|147354923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.143||||0.0067|TWO_SIDED|95.0|-0.246|-0.04|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.040|-0.246|0.0067
73912430|NCT01397890|147354924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.122||||0.0171|TWO_SIDED|95.0|-0.222|-0.022|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.022|-0.222|0.0171
73912431|NCT01397890|147354925|SUPERIORITY_OR_OTHER||Rate ratio|0.593||||0.0032|TWO_SIDED|95.0|0.419|0.839|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable morning PEF as a covariate||||0.839|0.419|0.0032
73912432|NCT01397890|147354925|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.614||||0.0167|TWO_SIDED|95.0|0.412|0.916|||Regression, Cox|Time to the first COPD exacerbation||||0.916|0.412|0.0167
73912433|NCT01397890|147354925|SUPERIORITY_OR_OTHER|||||||0.0196|||||||Log Rank|||||||0.0196
73912434|NCT00002651|147354926|NON_INFERIORITY_OR_EQUIVALENCE|The overall type I error rate used is 0.05. The type II error rate is 0.10 (power = 0.9). The trial planned for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. A hazard ratio of 1.0 was used as the specific alternative in the trial size computations. Thus, rejection of the hypothesis will be evidence against the possibility that the intermittent CAD hazard ratio is larger than the continuous CAD hazard ratio by 20% or more.|Hazard Ratio (HR)|1.1||||0.15|TWO_SIDED|90.0|0.99|1.23|||Regression, Cox|||||1.23|0.99|0.15
74085498|NCT01396421|147724968|SUPERIORITY_OR_OTHER||Least squares mean|-1.78||||0.0007|TWO_SIDED|95.0|-2.81|-0.76||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.76|-2.81|0.0007
73912435|NCT00002651|147354927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83||||0.09|TWO_SIDED|95.0|-0.31|3.97||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||3.97|-0.31|0.09
73912436|NCT00002651|147354928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.88||||0.003|TWO_SIDED|95.0|1.0|4.76||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||4.76|1.00|0.003
73912437|NCT00002651|147354929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.0|||<|0.001|TWO_SIDED|95.0|-14.0|-5.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||-5|-14|<0.001
73912438|NCT00002651|147354930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0||||0.04|TWO_SIDED|95.0|1.0|36.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||36|1|0.04
73858311|NCT01960998|147262234|SUPERIORITY|||||||0.7||||||P values were not corrected for multiple testing|ANCOVA|Baseline score was included as a covariate in analysis.|||Mean values for the telehealth and no telehealth groups on the ICIQ-SF are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean ICIQ-SF score in the no telehealth group at 6 months was 7.0 (standard deviation 4.4) and in the telehealth group was 7.1 (SD 4.3). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline ICIQ-SF score, and p values were combined using the Rubin-Licht method.|||0.70
73912439|NCT00002651|147354931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.23|TWO_SIDED|95.0|-0.83|3.46||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||3.46|-0.83|0.23
73858312|NCT01960998|147262235|SUPERIORITY|||||||0.7||||||P values were not adjusted for multiple comparisons.|ANCOVA||||Mean values for the telehealth and no telehealth groups on the EPIC-UI are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPIC-UI score in the no telehealth group at 6 months was 63.5 (standard deviation 24.1) and in the telehealth group was 63.9 (SD 22.1). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline EPIC-UI score, and p values were combined using the Rubin-Licht method.|||0.70
73858313|NCT01960998|147262236|SUPERIORITY|||||||0.46||||||P values not adjusted for multiple comparisons.|t-test, 2 sided||||Mean values for the telehealth and no telehealth groups on the IIQ are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean IIQ score in the no telehealth group at 6 months was 22.3 (standard deviation 24.1) and in the telehealth group was 19.4 (SD 22.4). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.|||0.46
73858314|NCT01960998|147262237|SUPERIORITY|||||||0.63||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Quality of Life question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 31.4% (Delighted/Pleased), 22.8% (Mostly Satisfied), 19.4% (Mixed), 12.0% (Mostly Dissatisfied), and 14.4% (Unhappy/Terrible) and in the telehealth group were 20.8%, 26.3%, 26.3%, 12.6%, and 14.0%, respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the IPSS Quality of Life question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.63
73858315|NCT01960998|147262238|SUPERIORITY|||||||0.04||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Patient Satisfaction question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Completely Satisfied), 40.2% (Somewhat Satisfied), and 8.7% (Not at All Satisfied) and in the telehealth group were 34.8%, 59.9%, and 5.3%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Patient Satisfaction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.04
73912440|NCT00304746|147354948|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||For a complete presentation of the above analysis, please see the published paper presenting the full results of this study.|mixed effects linear regression analysis|||Our primary analysis of efficacy was a mixed effects linear regression analysis comparing the rate of change of score on the HAM-D during the blinded treatment phase between groups. Our model for the mean of the outcome variable included terms for treatment, time (modeled as a continuous variable), and treatment-by-time. The measure of effect was the treatment-by-time interaction, which can be interpreted as the difference in slope with respect to time, of the outcome measure.||||0.71
73912441|NCT02527161|147354961|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74085499|NCT01396421|147724968|SUPERIORITY_OR_OTHER||Treatmetn difference|-1.07||||0.0996|TWO_SIDED|95.0|-2.33|0.2||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.20|-2.33|0.0996
74085500|NCT01396421|147724969|SUPERIORITY_OR_OTHER||Treatment difference|-0.5||||0.0004|TWO_SIDED|95.0|-0.77|-0.22||The Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||-0.22|-0.77|0.0004
74085501|NCT01396421|147724969|SUPERIORITY_OR_OTHER||Treatment difference|-0.54||||0.0002|TWO_SIDED|95.0|-0.82|-0.26||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||-0.26|-0.82|0.0002
73912442|NCT02527161|147354962|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS Pain||||<0.0001
73912443|NCT02527161|147354962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||ANOVA|||Change from 6 weeks to 3 months KOOS Pain||||0.0013
73912444|NCT02527161|147354962|SUPERIORITY|||||||0.3316|||||||ANOVA|||Change from 3 months to 6 months KOOS Pain||||0.3316
73912445|NCT02527161|147354962|SUPERIORITY|||||||0.3366|||||||ANOVA|||Change from 6 months to 1 year KOOS Pain||||0.3366
73912446|NCT02527161|147354962|SUPERIORITY|||||||0.9826|||||||ANOVA|||Change from 1 year to 2 year KOOS Pain||||0.9826
73912447|NCT02527161|147354962|SUPERIORITY|||||||0.9276|||||||ANOVA|||Change from 2 year to 5 year KOOS Pain||||0.9276
73912448|NCT02527161|147354963|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS Symptoms||||<0.0001
74085502|NCT01396421|147724969|SUPERIORITY_OR_OTHER||Treatment difference|-0.14||||0.4505|TWO_SIDED|95.0|-0.5|0.22||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||0.22|-0.50|0.4505
74085503|NCT01396421|147724970|SUPERIORITY_OR_OTHER||Relative risk|1.48||||0.0032|TWO_SIDED|95.0|1.14|1.91||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||1.91|1.14|0.0032
73858316|NCT01960998|147262239|SUPERIORITY|||||||0.67||||||P values not adjusted for multiple comparisons|t-test, 2 sided||||Mean values for the telehealth and no telehealth groups on the Estimated Percent Improvement (EPI) are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPI score in the no telehealth group at 6 months was 65.1 (standard deviation 34.5) and in the telehealth group was 69.6 (SD 29.6). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.|||0.67
73858317|NCT01960998|147262240|SUPERIORITY|||||||0.65|||||||Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Global Perception of Improvement (GPI) question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 46.3% (Much Better), 30.7% (Better), 16.7% (About the Same), 2.3% (Worse), and 3.9% (Much Worse) and in the telehealth group were 38.3%, 41.1%, 15.3%, 2.9%, and 2.5%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the Global Perception of Improvement question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.65
73858318|NCT01960998|147262241|SUPERIORITY|||||||0.37||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||"Frequencies for the telehealth and no telehealth groups on the How Disturbing is the Urine Leakage? question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 43.5% (Not at All), 44.4% (Somewhat), and 12.1% (Extremely) and in the telehealth group were 38.9%, 53.2%, and 7.9% respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the How Disturbing is the Urine Leakage? question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method."|||0.37
73858319|NCT01960998|147262242|SUPERIORITY|||||||0.63||||||P values were not adjusted for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Activity Restriction question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Not at all), 36.5% (Some of the time), 7.2% (Most of the time), and 5.3% (All of the time) and in the telehealth group were 56.5%, 33.5%, 4.2%, and 5.8% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Activity Restriction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.63
73858320|NCT01960998|147262243|SUPERIORITY|||||||0.71||||||P values not adjusted for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Return to Work question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 52.3% (Yes), 5.0% (No, not yet recovered from surgery), 1.9% (No, other reason), and 40.7% (Retired or disabled) and in the telehealth group were 62.3%, 3.5%, 0.8%, and 33.5% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Return to Work question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.71
74085504|NCT01396421|147724970|SUPERIORITY_OR_OTHER||Relative risk|1.59||||0.0004|TWO_SIDED|95.0|1.23|2.05||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||2.05|1.23|0.0004
74085505|NCT01396421|147724970|SUPERIORITY_OR_OTHER||Relative risk|1.27||||0.1576|TWO_SIDED|95.0|0.92|1.76||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||1.76|0.92|0.1576
73858321|NCT01960998|147262244|SUPERIORITY|||||||0.41||||||P values not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Resumption of Normal Activities question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 7.4% (None), 29.8% (Some), 62.8% (All) and in the telehealth group were 4.9%, 23.0%, and 72.2% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Resumption of Normal Activities question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.41
73912449|NCT02527161|147354963|SUPERIORITY|||||||0.0736|||||||ANOVA|||Change from 6 weeks to 3 months KOOS Symptoms||||0.0736
74085506|NCT01396421|147724971|SUPERIORITY_OR_OTHER||Treatment difference|-1.1||||0.0246|TWO_SIDED|95.0|-2.06|-0.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.14|-2.06|0.0246
74085507|NCT01396421|147724971|SUPERIORITY_OR_OTHER||Treatment difference|-1.22||||0.0131|TWO_SIDED|95.0|-2.19|-0.26||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.26|-2.19|0.0131
74085508|NCT01396421|147724971|SUPERIORITY_OR_OTHER||Treatment difference|-0.34||||0.5706|TWO_SIDED|95.0|-1.53|0.85||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.85|-1.53|0.5706
73858322|NCT00759356|147262245|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|Mean ratio|109.8||||||90.0|95.3|126.5|||ANOVA|||||126.5|95.3|
73912450|NCT02527161|147354963|SUPERIORITY|||||||0.4675|||||||ANOVA|||Change from 3 months to 6 months KOOS Symptoms||||0.4675
74026722|NCT01287117|147607058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.0879|TWO_SIDED|95.0|0.95|2.03||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||2.03|0.95|0.0879
73858323|NCT00759356|147262247|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.5||||||90.0|95.6|107.9|||ANOVA|||||107.9|95.6|
73858324|NCT00759356|147262248|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|95.9|107.9|||ANOVA|log-transformation||||107.9|95.9|
73858325|NCT00812006|147262273|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
73858326|NCT00812006|147262274|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.||||||<0.001
73858327|NCT00812006|147262275|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
73858328|NCT00812006|147262276|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's falsediscovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
73858329|NCT00812006|147262277|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.||||||<0.001
73858330|NCT02956044|147262280|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|108.73|||||TWO_SIDED|95.0|94.35|125.3|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric Least Square (LS) Mean was used as PK parameters||125.30|94.35|
73858331|NCT02956044|147262280|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|95.05|||||TWO_SIDED|90.0|84.73|106.63|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||106.63|84.73|
73858332|NCT02956044|147262280|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|89.44|||||TWO_SIDED|90.0|70.39|113.65|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||113.65|70.39|
73858333|NCT02956044|147262280|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|111.95|||||TWO_SIDED|90.0|97.02|129.19|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||129.19|97.02|
73858334|NCT02956044|147262280|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|126.68|||||TWO_SIDED|90.0|112.08|143.17|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||143.17|112.08|
73858335|NCT02956044|147262280|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|98.48|||||TWO_SIDED|90.0|84.9|114.23|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||114.23|84.90|
73858336|NCT02956044|147262283|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|87.36|||||TWO_SIDED|90.0|80.02|95.38|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||95.38|80.02|
73858337|NCT02956044|147262283|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|103.24|||||TWO_SIDED|90.0|94.59|112.68|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||112.68|94.59|
73912451|NCT02527161|147354963|SUPERIORITY|||||||0.0229|||||||ANOVA|||Change from 6 months to 1 year KOOS Symptoms||||0.0229
73912452|NCT02527161|147354963|SUPERIORITY|||||||0.9968|||||||ANOVA|||Change from 1 year to 2 year KOOS Symptoms||||0.9968
73912453|NCT02527161|147354963|SUPERIORITY|||||||0.7761|||||||ANOVA|||Change from 2 year to 5 year KOOS Symptoms||||0.7761
73912454|NCT02527161|147354964|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS ADL||||<0.0001
73912455|NCT02527161|147354964|SUPERIORITY|||||||0.0212|||||||ANOVA|||Change from 6 weeks to 3 months KOOS ADL||||0.0212
73912456|NCT02527161|147354964|SUPERIORITY|||||||0.7173|||||||ANOVA|||Change from 3 months to 6 months KOOS ADL||||0.7173
73912457|NCT02527161|147354964|SUPERIORITY|||||||0.1834|||||||ANOVA|||Change from 6 months to 1 year KOOS ADL||||0.1834
73912458|NCT02527161|147354964|SUPERIORITY|||||||0.9957|||||||ANOVA|||Change from 1 year to 2 year KOOS ADL||||0.9957
73912459|NCT02527161|147354964|SUPERIORITY|||||||0.9999|||||||ANOVA|||Change from 6 months to 1 year KOOS ADL||||0.9999
74085509|NCT01396421|147724972|SUPERIORITY_OR_OTHER||Relative risk|0.39||||0.0143|TWO_SIDED|95.0|0.18|0.85|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.||||0.85|0.18|0.0143
74085510|NCT01396421|147724972|SUPERIORITY_OR_OTHER||Relative risk|0.87||||0.6606|TWO_SIDED|95.0|0.46|1.65||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel|||||1.65|0.46|0.6606
74085511|NCT01396421|147724972|SUPERIORITY_OR_OTHER||Relative risk|0.77||||0.5115|TWO_SIDED|95.0|0.35|1.68||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel|||||1.68|0.35|0.5115
74085512|NCT01396421|147724973|SUPERIORITY_OR_OTHER||Treatment difference|-2.34||||0.0014|TWO_SIDED|95.0|-3.77|-0.91||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.91|-3.77|0.0014
73858338|NCT02956044|147262283|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|94.46|||||TWO_SIDED|90.0|80.34|111.06|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||111.06|80.34|
73858339|NCT02956044|147262283|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|[Ratio of Geometric LSM]|127.19|||||TWO_SIDED|90.0|110.33|146.62|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||146.62|110.33|
74085513|NCT01396421|147724973|SUPERIORITY_OR_OTHER||Treatment difference|-2.47||||0.0008|TWO_SIDED|95.0|-3.91|-1.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-1.04|-3.91|0.0008
73858340|NCT02956044|147262283|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|[Ratio of Geometric LSM]|113.09|||||TWO_SIDED|90.0|107.61|118.86|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||118.86|107.61|
73858341|NCT02956044|147262283|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|[Ratio of Geometric LSM]|103.16|||||TWO_SIDED|90.0|99.3|107.17||||||Geometric LS Mean was used as PK parameters|Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|107.17|99.30|
73858342|NCT00098748|147262285|NON_INFERIORITY_OR_EQUIVALENCE|For hypothesis of superiority, if upper bound of 97.5% confidence interval (CI) of TX difference was \<0 log10 copies/mL, it was concluded that MVC regimen was superior to PBO meaning that MVC added to Optimized Background Therapy (OBT) provides an additional reduction in plasma HIV-1 RNA compared to OBT alone. If superiority could not be concluded, then a hypothesis of noninferiority was tested. If upper bound of CI is \<0.25 log10 copies/mL, noninferiority of MVC regimen to placebo was claimed.|Least squares mean|0.055|STANDARD_ERROR_OF_MEAN|0.2575|||TWO_SIDED|97.5|-0.528|0.638|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC versus (vs) PBO=advantage of MVC.|Maraviroc (MVC) QD versus placebo (PBO) treatment (TX) difference at Week 24. If upper bound of 97.5% confidence interval is \<0, it is concluded that dose is superior to PBO. If upper bound is \<0.25, it is concluded that MVC is non-inferior to PBO. Assumption: 79% of subjects are dual-tropic; total N=192 needed to be randomized to get N=150 dual-tropic. Standard deviation=0.8 with 2-sided p-value=0.025: 80% power for TX difference of 0.5 for change from baseline in log10-transformed viral load.||0.638|-0.528|
74085514|NCT01396421|147724973|SUPERIORITY_OR_OTHER||Treatment difference|-0.89||||0.3263|TWO_SIDED|95.0|-2.66|0.89||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|||||0.89|-2.66|0.3263
74085515|NCT01396421|147724974|SUPERIORITY_OR_OTHER||Treatment difference|-1.3||||0.0155|TWO_SIDED|95.0|-2.35|-0.25||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.25|-2.35|0.0155
74085516|NCT01396421|147724974|SUPERIORITY_OR_OTHER||Treatment difference|-1.68||||0.0019|TWO_SIDED|95.0|-2.73|-0.62||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.62|-2.73|0.0019
74085517|NCT01396421|147724974|SUPERIORITY_OR_OTHER||Treatment difference|-0.86||||0.1956|TWO_SIDED|95.0|-2.17|0.44||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.44|-2.17|0.1956
74085518|NCT01396421|147724975|SUPERIORITY_OR_OTHER||Treatment difference|-1.75||||0.0007|TWO_SIDED|95.0|-2.76|-0.75||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.75|-2.76|0.0007
74085519|NCT01396421|147724975|SUPERIORITY_OR_OTHER||Treatment difference|-1.98||||0.0001|TWO_SIDED|95.0|-2.98|-0.97||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.97|-2.98|0.0001
74085520|NCT01396421|147724975|SUPERIORITY_OR_OTHER||Treatment difference|-0.72||||0.2572|TWO_SIDED|95.0|-1.96|0.52||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.52|-1.96|0.2572
74085521|NCT01396421|147724976|SUPERIORITY_OR_OTHER||Treatment difference|-1.07||||0.0085|TWO_SIDED|95.0|-1.87|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.28|-1.87|0.0085
73912460|NCT02527161|147354965|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS S\&R||||<0.0001
73912461|NCT02527161|147354965|SUPERIORITY|||||||0.0522|||||||ANOVA|||Change from 6 weeks to 3 months KOOS S\&R||||0.0522
74026723|NCT01287117|147607058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.0301|TWO_SIDED|95.0|1.04|2.14||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||2.14|1.04|0.0301
73858343|NCT00098748|147262285|SUPERIORITY_OR_OTHER||Least squares mean|-0.232|STANDARD_ERROR_OF_MEAN|0.2637|||TWO_SIDED|97.5|-0.829|0.364|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||0.364|-0.829|
73858344|NCT00098748|147262285|SUPERIORITY_OR_OTHER||Least squares mean|0.229|STANDARD_ERROR_OF_MEAN|0.2567|||TWO_SIDED|97.5|-0.351|0.81|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||0.810|-0.351|
73858345|NCT00098748|147262285|SUPERIORITY_OR_OTHER||Least squares mean|-0.261|STANDARD_ERROR_OF_MEAN|0.2628|||TWO_SIDED|97.5|-0.856|0.333|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||0.333|-0.856|
73858346|NCT00098748|147262286|SUPERIORITY_OR_OTHER||difference in proportions|0.03|||||TWO_SIDED|95.0|-0.12|0.18|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.18|-0.12|
73858347|NCT00098748|147262286|SUPERIORITY_OR_OTHER||difference in proportions|0.07|||||TWO_SIDED|95.0|-0.08|0.23|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.23|-0.08|
73858348|NCT00098748|147262286|SUPERIORITY_OR_OTHER||difference in proportions|0.02|||||TWO_SIDED|95.0|-0.12|0.17|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.17|-0.12|
73858349|NCT00098748|147262286|SUPERIORITY_OR_OTHER||difference in proportions|0.09|||||TWO_SIDED|95.0|-0.07|0.25|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.25|-0.07|
73858350|NCT00098748|147262287|SUPERIORITY_OR_OTHER||difference in proportions|0.03|||||TWO_SIDED|95.0|-0.15|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.20|-0.15|
73858351|NCT00098748|147262287|SUPERIORITY_OR_OTHER||difference in proportions|0.08|||||TWO_SIDED|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.26|-0.10|
73858352|NCT00098748|147262287|SUPERIORITY_OR_OTHER||difference in proportions|-0.06|||||TWO_SIDED|95.0|-0.22|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.10|-0.22|
73858353|NCT00098748|147262287|SUPERIORITY_OR_OTHER||difference in proportions|0.11|||||TWO_SIDED|95.0|-0.07|0.28|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.28|-0.07|
73858354|NCT00098748|147262288|SUPERIORITY_OR_OTHER||difference in proportions|-0.05|||||TWO_SIDED|95.0|-0.21|0.12|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.12|-0.21|
73858355|NCT00098748|147262288|SUPERIORITY_OR_OTHER||difference in proportions|0.08|||||TWO_SIDED|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.26|-0.10|
73858356|NCT00098748|147262288|SUPERIORITY_OR_OTHER||difference in proportions|-0.02|||||TWO_SIDED|95.0|-0.18|0.13|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.13|-0.18|
73858357|NCT00098748|147262288|SUPERIORITY_OR_OTHER||difference in proportions|0.12|||||TWO_SIDED|95.0|-0.04|0.29|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.29|-0.04|
73912462|NCT02527161|147354965|SUPERIORITY|||||||0.1696|||||||ANOVA|||Change from 3 months to 6 months KOOS S\&R||||0.1696
73912463|NCT02527161|147354965|SUPERIORITY|||||||0.6942|||||||ANOVA|||Change from 6 months to 1 year KOOS S\&R||||0.6942
74085522|NCT01396421|147724976|SUPERIORITY_OR_OTHER||Treatment difference|-1.08||||0.0081|TWO_SIDED|95.0|-1.88|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.28|-1.88|0.0081
74085523|NCT01396421|147724976|SUPERIORITY_OR_OTHER||Treatment difference|-0.33||||0.5172|TWO_SIDED|95.0|-1.31|0.66||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.66|-1.31|0.5172
73858358|NCT00098748|147262289|SUPERIORITY_OR_OTHER||difference in proportions|0.07|||||TWO_SIDED|95.0|-0.07|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.20|-0.07|
73858359|NCT00098748|147262289|SUPERIORITY_OR_OTHER||difference in proportions|0.11|||||TWO_SIDED|95.0|-0.03|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO difference in proportions at Week 24.||0.26|-0.03|
73858360|NCT00098748|147262289|SUPERIORITY_OR_OTHER||difference in proportions|-0.04|||||TWO_SIDED|95.0|-0.18|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.10|-0.18|
73858361|NCT00098748|147262289|SUPERIORITY_OR_OTHER||difference in proportions|0.06|||||TWO_SIDED|95.0|-0.1|0.21|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.21|-0.10|
73858362|NCT00098748|147262290|SUPERIORITY_OR_OTHER||Least squares mean|23.927|STANDARD_ERROR_OF_MEAN|12.8025|||TWO_SIDED|95.0|-1.359|49.213|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.||49.213|-1.359|
73858363|NCT00098748|147262290|SUPERIORITY_OR_OTHER||Least squares mean|26.679|STANDARD_ERROR_OF_MEAN|13.0678|||TWO_SIDED|95.0|0.869|52.49|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||52.490|0.869|
73858364|NCT00098748|147262290|SUPERIORITY_OR_OTHER||Least squares mean|14.61|STANDARD_ERROR_OF_MEAN|16.412|||TWO_SIDED|95.0|-17.8|47.03|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||47.03|-17.80|
73858365|NCT00098748|147262290|SUPERIORITY_OR_OTHER||Least squares mean|27.71|STANDARD_ERROR_OF_MEAN|16.754|||TWO_SIDED|95.0|-5.38|60.8|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||60.80|-5.38|
73858366|NCT00098748|147262291|SUPERIORITY_OR_OTHER||Least squares mean|234.499|STANDARD_ERROR_OF_MEAN|80.799|||TWO_SIDED|95.0|74.913|394.084|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.||394.084|74.913|
73858367|NCT00098748|147262291|SUPERIORITY_OR_OTHER||Least squares mean|188.817|STANDARD_ERROR_OF_MEAN|83.4484|||TWO_SIDED|95.0|23.999|353.635|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||353.635|23.999|
73858368|NCT00098748|147262291|SUPERIORITY_OR_OTHER||Least squares mean|155.94|STANDARD_ERROR_OF_MEAN|87.304|||TWO_SIDED|95.0|-16.49|328.37|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||328.37|-16.49|
73858369|NCT00098748|147262291|SUPERIORITY_OR_OTHER||Least squares mean|182.91|STANDARD_ERROR_OF_MEAN|90.174|||TWO_SIDED|95.0|4.81|361.02|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||361.02|4.81|
73858370|NCT00098748|147262292|SUPERIORITY_OR_OTHER|||||||0.7524||95.0|||||Log Rank|||MVC QD vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.7524
73858371|NCT00098748|147262292|SUPERIORITY_OR_OTHER|||||||0.254||95.0|||||Log Rank|||MVC BID vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.2540
73858372|NCT00098748|147262292|SUPERIORITY_OR_OTHER|||||||0.8243||95.0|||||Log Rank|||MVC QD vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.8243
73858373|NCT00098748|147262292|SUPERIORITY_OR_OTHER|||||||0.6657||95.0|||||Log Rank|||MVC BID vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.6657
73858374|NCT00098748|147262293|SUPERIORITY_OR_OTHER||Least squares mean|0.069|STANDARD_ERROR_OF_MEAN|0.2356|||TWO_SIDED|95.0|-0.396|0.535|||ANCOVA|TX difference adjusted for randomization strata.||MVC QD vs PBO treatment difference at Week 24.||0.535|-0.396|
73858375|NCT00098748|147262293|SUPERIORITY_OR_OTHER||Least squares mean|-0.218|STANDARD_ERROR_OF_MEAN|0.2413|||TWO_SIDED|95.0|-0.694|0.258|||ANCOVA|TX difference adjusted for randomization strata.||MVC BID vs PBO treatment difference at Week 24.||0.258|-0.694|
73858376|NCT00098748|147262293|SUPERIORITY_OR_OTHER||Least squares mean|0.209|STANDARD_ERROR_OF_MEAN|0.2388|||TWO_SIDED|95.0|-0.262|0.681|||ANCOVA|TX difference adjusted for randomization strata.||MVC QD vs PBO treatment difference at Week 48.||0.681|-0.262|
73858377|NCT00098748|147262293|SUPERIORITY_OR_OTHER||Least squares mean|-0.284|STANDARD_ERROR_OF_MEAN|0.2445|||TWO_SIDED|95.0|-0.767|0.199|||ANCOVA|TX difference adjusted for randomization strata.||MVC BID vs PBO treatment difference at Week 48.||0.199|-0.767|
73858378|NCT01081301|147262307|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of the Herth Hope Index over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
73858379|NCT01081301|147262308|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Mental health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
73858380|NCT01081301|147262309|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures||Generalized estimating equations were used to determine change in patterns of General Self Efficacy Scale scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
73858381|NCT01081301|147262310|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of Non Death Revised Grief Experience Inventory scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||>0.05
73858382|NCT01081301|147262311|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Physical health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
73858383|NCT03551665|147262312|OTHER||Mean Difference (Final Values)|0.029||||0.036|TWO_SIDED|95.0|0.002|0.056|||Regression, Linear|||These data are the immediate improvements (base 2 - post 1) in the MS group.||0.056|.002|0.036
73858384|NCT03551665|147262313|OTHER||Spearman's Rho|0.019||||0.92|||||||Spearman Correlation|||We correlated cognition (SDMT; above) to the improvement in performance (margin of stability) to to determine whether cognition predicted improvement in stepping outcomes.||||.92
73858385|NCT03551665|147262314|OTHER||Mean Difference (Final Values)|0.026||||0.119||95.0|-0.007|0.059|||Regression, Linear|||We assessed the change in reactive step length before (Baseline 2) to immediately after (post 1) training in the MS group||0.059|-0.007|0.119
73858386|NCT03551665|147262315|OTHER||Mean Difference (Final Values)|-0.041||||0.012||95.0|-0.073|-0.009|||Regression, Linear|||We assessed the change in reactive step latency before (Baseline 2) to immediately after (post 1) training in the MS group||-0.009|-0.073|0.012
74085524|NCT01396421|147724977|SUPERIORITY_OR_OTHER||Treatment difference|-0.34||||0.3284|TWO_SIDED|95.0|-1.03|0.35||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.35|-1.03|0.3284
73858387|NCT01545232|147262356|SUPERIORITY_OR_OTHER||Adjusted Relative Risk|0.75||||0.12|TWO_SIDED|95.0|0.52|1.08|||Mantel Haenszel|The critical level for significance (p\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size (580) planned to detect a clinically meaningful 10% difference in 24-hour mortality (11% vs. 21%) supported by prior data. Data Safety Monitoring Board (DSMB) increased sample size to 680 according to trial's adaptive design. With 680 pts. \& given the final observed mortality proportions in 1:1:1 group, PROPPR had 95% power to detect the pre-specified 10% difference at 24 hours if such differences existed.||1.08|0.52|0.12
73858388|NCT01545232|147262357|SUPERIORITY_OR_OTHER||Adjusted Relative Risk|0.86||||0.26|TWO_SIDED|95.0|0.65|1.12|||Mantel Haenszel|The critical level for significance (p\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size of 580 planned to detect clinically meaningful a 12% difference in 30-day mortality (23% vs. 35%),supported by prior data. DSMB increased sample size to 680 according to trial's adaptive design. With 680 patients \& given final observed mortality proportions in the 1:1:1 group, PROPPR had 92% power to detect the pre-specified 12% difference at 30 days, if such differences existed.||1.12|0.65|0.26
73858389|NCT01545232|147262359|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||van Elteren's test for medians|||||||0.83
73858390|NCT01545232|147262360|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||van Elteren's test for medians|||||||0.44
73858391|NCT01545232|147262362|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||van Elteren's test for medians|||||||0.11
73858392|NCT01545232|147262363|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-2.8|8.3||||||||8.3|-2.8|
73858393|NCT01545232|147262364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.8|1.7||||||||1.7|-0.8|
73858394|NCT01545232|147262365|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||generalized logit model regression|||||||0.37
73858395|NCT01545232|147262366|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||van Elteren's test for medians|||||||0.14
73912464|NCT02527161|147354965|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year KOOS S\&R||||>0.9999
73912465|NCT02527161|147354965|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year KOOS S\&R||||>0.9999
73912466|NCT02527161|147354966|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS QoL||||<0.0001
73912467|NCT02527161|147354966|SUPERIORITY|||||||0.0135|||||||ANOVA|||Change from 6 weeks to 3 months KOOS QoL||||0.0135
73912468|NCT02527161|147354966|SUPERIORITY|||||||0.0829|||||||ANOVA|||Change from 3 months to 6 months KOOS QoL||||0.0829
73912469|NCT02527161|147354966|SUPERIORITY|||||||0.1729|||||||ANOVA|||Change from 6 months to 1 year KOOS QoL||||0.1729
73912470|NCT02527161|147354966|SUPERIORITY|||||||0.9687|||||||ANOVA|||Change from 1 year to 2 year KOOS QoL||||0.9687
73912471|NCT02527161|147354966|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year KOOS QoL||||>0.9999
73912472|NCT02527161|147354967|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks SF-12 PCS||||<0.0001
73912473|NCT02527161|147354967|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from 6 weeks to 3 months SF-12 PCS||||<0.0001
73912474|NCT02527161|147354967|SUPERIORITY|||||||0.8189|||||||ANOVA|||Change from 3 months to 6 months SF-12 PCS||||0.8189
74085525|NCT01396421|147724977|SUPERIORITY_OR_OTHER||Treatment difference|-0.65||||0.0655|TWO_SIDED|95.0|-1.34|0.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.04|-1.34|0.0655
73912475|NCT02527161|147354967|SUPERIORITY|||||||0.9845|||||||ANOVA|||Change from 6 months to 1 year SF-12 PCS||||0.9845
73912476|NCT02527161|147354967|SUPERIORITY|||||||0.75|||||||ANOVA|||Change from 1 year to 2 year SF-12 PCS||||0.7500
73912477|NCT02527161|147354967|SUPERIORITY|||||||0.1376|||||||ANOVA|||Change from 2 year to 5 year SF-12 PCS||||0.1376
73912478|NCT02527161|147354968|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 week VAS Rest||||<0.0001
73912479|NCT02527161|147354968|SUPERIORITY|||||||0.0031|||||||ANOVA|||Change from 6 weeks to 3 months VAS Rest||||0.0031
73912480|NCT02527161|147354968|SUPERIORITY|||||||0.299|||||||ANOVA|||Change from 3 months to 6 months VAS Rest||||0.2990
73912481|NCT02527161|147354968|SUPERIORITY|||||||0.9832|||||||ANOVA|||Change from 6 months to 1 year VAS Rest||||0.9832
73912482|NCT02527161|147354968|SUPERIORITY|||||||0.9991|||||||ANOVA|||Change from 1 year to 2 year VAS Rest||||0.9991
73912483|NCT02527161|147354968|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year VAS Rest||||>0.9999
73912484|NCT02527161|147354969|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks VAS Mob||||<0.0001
73912485|NCT02527161|147354969|SUPERIORITY|||||||0.0062|||||||ANOVA|||Change from 6 weeks to 3 months VAS Mob||||0.0062
73912486|NCT02527161|147354969|SUPERIORITY|||||||0.373|||||||ANOVA|||Change from 3 months to 6 months VAS Mob||||0.3730
73912487|NCT02527161|147354969|SUPERIORITY|||||||0.8499|||||||ANOVA|||Change from 6 months to 1 year VAS Mob||||0.8499
73912488|NCT02527161|147354969|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year VAS Mob||||>0.9999
73912489|NCT02527161|147354969|SUPERIORITY|||||||0.9958|||||||ANOVA|||Change from 2 year to 5 year VAS Mob||||0.9958
73912490|NCT02527161|147354970|SUPERIORITY|||||||0.3493|||||||ANOVA|||Change from preoperative to 6 weeks SF-12 MCS||||0.3493
73912491|NCT02527161|147354970|SUPERIORITY|||||||0.48|||||||ANOVA|||Change from 6 weeks to 3 months SF-12 MCS||||0.4800
73912492|NCT02527161|147354970|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 3 months to 6 months SF-12 MCS||||>0.9999
73912493|NCT02527161|147354970|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 6 months to 1 year SF-12 MCS||||>0.9999
73912494|NCT02527161|147354970|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year SF-12 MCS||||>0.9999
73912495|NCT02527161|147354970|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year SF-12 MCS||||>0.9999
73912496|NCT02527161|147354971|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KSS Pain||||<0.0001
73912497|NCT02527161|147354971|SUPERIORITY|||||||0.9465|||||||ANOVA|||Change from 3 months to 6 months KSS Pain||||0.9465
73912498|NCT02527161|147354971|SUPERIORITY|||||||0.1215|||||||ANOVA|||Change from 6 months to 1 year KSS Pain||||0.1215
73912499|NCT02527161|147354971|SUPERIORITY|||||||0.9912|||||||ANOVA|||Change from 1 year to 2 years KSS Pain||||0.9912
73912500|NCT02527161|147354971|SUPERIORITY|||||||0.8952|||||||ANOVA|||Change from 2 year to 5 year KSS Pain||||0.8952
73912501|NCT02527161|147354972|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 3 months KSS Function||||<0.0001
73912502|NCT02527161|147354972|SUPERIORITY|||||||0.0266|||||||ANOVA|||Change from 3 months to 6 months KSS Function||||0.0266
73912503|NCT02527161|147354972|SUPERIORITY|||||||0.988|||||||ANOVA|||Change from 6 months to 1 year KSS Function||||0.9880
73912504|NCT02527161|147354972|SUPERIORITY|||||||0.9699|||||||ANOVA|||Change from 1 year to 2 years KSS Function||||0.9699
73912505|NCT02527161|147354972|SUPERIORITY|||||||0.8575|||||||ANOVA|||Change from 2 year to 5 years KSS Function||||0.8575
73912506|NCT02527161|147354973|SUPERIORITY|||||||0.8581|||||||ANOVA|||Change from preoperative to 3 months KSS Range of Motion||||0.8581
73912507|NCT02527161|147354973|SUPERIORITY|||||||0.7664|||||||ANOVA|||Change from 3 months to 6 months KSS Range of Motion||||0.7664
73912508|NCT02527161|147354973|SUPERIORITY|||||||0.7022|||||||ANOVA|||Change from 6 months to 1 year KSS Range of Motion||||0.7022
73912509|NCT02527161|147354973|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year KSS Range of Motion||||>0.9999
73912510|NCT02527161|147354973|SUPERIORITY|||||||0.2943|||||||ANOVA|||Change from 2 year to 5 year KSS Range of Motion||||0.2943
73912511|NCT02527161|147354974|SUPERIORITY|||||||0.0161|||||||ANOVA|||Change from 1 year to 2 year Forgotten Joint Score||||0.0161
73912512|NCT02527161|147354974|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from 2 year to 5 year Forgotten Joint Score||||<0.0001
74085526|NCT01396421|147724977|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.6251|TWO_SIDED|95.0|-1.07|0.64||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.64|-1.07|0.6251
74085527|NCT04728620|147724978|SUPERIORITY|single group|mean|79.3||||0.001|TWO_SIDED||||||t-test, 1 sided|||"One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is 71 or less."||||0.001
74085528|NCT04728620|147724980|OTHER||Mean Difference (Net)|0.57||||0.005|TWO_SIDED||||||t-test, 2 sided|||||||0.005
73912513|NCT02100514|147354988|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-49.9|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-54.0|-45.8|||MMRM|||Least square (LS) mean difference and associated 95% confidence interval (CI), and p-value were derived from an mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-45.8|-54.0|<0.001
73912514|NCT02100514|147354989|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-33.2|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-36.1|-30.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-30.2|-36.1|<0.001
73912515|NCT02100514|147354989|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-29.6|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-32.8|-26.3||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-26.3|-32.8|
73912516|NCT02100514|147354989|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-23.8|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|95.0|-27.0|-20.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-20.5|-27.0|
73912517|NCT02100514|147354990|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-45.7|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-49.7|-41.7|||MMRM|||Week 12: LS mean difference and associated 95% CI, and p-value were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-41.7|-49.7|<0.001
73912518|NCT02100514|147354990|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-40.9|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-45.3|-36.5||||||Week 24: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-36.5|-45.3|
73912519|NCT02100514|147354990|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-32.5|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|95.0|-36.7|-28.2||||||Week 52: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-28.2|-36.7|
73912520|NCT02100514|147354991|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-45.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-48.9|-41.1|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-41.1|-48.9|<0.001
73912521|NCT02100514|147354991|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-40.5|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|-44.8|-36.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-36.1|-44.8|
73912522|NCT02100514|147354991|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-32.7|STANDARD_ERROR_OF_MEAN|2.2|||TWO_SIDED|95.0|-37.0|-28.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-28.4|-37.0|
73912523|NCT02100514|147354992|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-51.6|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-56.7|-46.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-46.6|-56.7|<0.001
73912524|NCT02100514|147354992|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-46.4|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-52.2|-40.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-40.6|-52.2|
73912525|NCT02100514|147354992|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-37.4|STANDARD_ERROR_OF_MEAN|3.03|||TWO_SIDED|95.0|-43.3|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-31.4|-43.3|
73965226|NCT04059042|147465487|EQUIVALENCE|Between-session pain measures were assessed with related-samples Wilcoxon signed-rank tests (Audio minus Silence). Data were not normally distributed so nonparametric tests were used.|Z score|18.0||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.59
74085529|NCT04728620|147724981|OTHER||Mean Difference (Net)|-0.85||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
74085530|NCT04728620|147724982|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended A1c monitoring frequency||||1
74085531|NCT04728620|147724982|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended urine microalbumin screening frequency||||1
74085532|NCT04728620|147724982|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended pneumonia vaccination frequency||||1
74085533|NCT04728620|147724982|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended diabetes eye exam frequency||||1
73912526|NCT02100514|147354993|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-46.6|STANDARD_ERROR_OF_MEAN|3.59|<|0.001||95.0|-53.7|-39.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-39.5|-53.7|<0.001
73912527|NCT02100514|147354993|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-39.7|STANDARD_ERROR_OF_MEAN|4.12||||95.0|-47.9|-31.6||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-31.6|-47.9|
73912528|NCT02100514|147354993|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-33.4|STANDARD_ERROR_OF_MEAN|4.02||||95.0|-41.3|-25.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-25.5|-41.3|
73912529|NCT02100514|147354994|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-30.8|STANDARD_ERROR_OF_MEAN|3.14|<|0.001||95.0|-36.9|-24.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-24.6|-36.9|<0.001
74085534|NCT02030535|147725021|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.219|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.187|0.252||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation|Tio+Olo 5/5μg minus Placebo.|||0.252|0.187|<0.0001
73858396|NCT01545232|147262367|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||van Elteren's test for medians|||||||0.10
73858397|NCT00378599|147262393|SUPERIORITY_OR_OTHER||Binomial Approximation|0.288|||||TWO_SIDED|95.0|0.21|0.38||||||||0.38|0.21|
73858398|NCT00489736|147262394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59|||<|0.0001||95.0|1.28|1.98||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of treatment failure for the dronedarone group compared with the amiodarone group.|||1.98|1.28|<0.0001
73858399|NCT00489736|147262395|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.13||95.0|0.6|1.07||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of main safety event occurrence for the dronedarone group compared with the amiodarone group.|||1.07|0.60|0.13
73858400|NCT00489736|147262396|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.002||95.0|0.44|0.84||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of MSE occurrence excluding gastrointestinal events, for the dronedarone group compared with the amiodarone group.|||0.84|0.44|0.002
73858401|NCT03920293|147262492|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.49|=|0.0009|TWO_SIDED|95.0|-2.6|-0.7||Statistical significance was tested at α=0.05.|MMRM|||||-0.7|-2.6|=0.0009
73858402|NCT01691885|147262499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.83|||<|0.001|TWO_SIDED|95.0|2.74|8.91|||ANCOVA|Analysis was performed using an ANCOVA model with covariates of treatment, baseline, period and subject as a random effect.||||8.91|2.74|<0.001
73858403|NCT03989427|147262509|EQUIVALENCE|The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p \< 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.|Mean Difference (Net)|1.424||||0.022|TWO_SIDED|95.0|0.221|2.628||The threshold for statistical significance was p \<0.05|ANOVA|Three-way mixed ANOVA was done to determine the effect of Intervention on BPI scores .||"Null hypothesis is that the sequence of brushing first and flossing later has no effect on gingival inflammation.~No previous studies with Mean and SD were available. Hence, a pilot study was done. 30 participants were randomly assigned to Brush first and floss later (BF) group ; and Floss first brush later(FB) group. After 1 week there was cross-over. 80% power is required to detect mean difference in BPI scores."||2.628|0.221|0.022
73858404|NCT03989427|147262510|EQUIVALENCE|The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p \< 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.|Mean Difference (Net)|-0.058||||0.971|TWO_SIDED|95.0|-3.335|3.219|||ANOVA|Three-way mixed ANOVA was done to determine the effect of Intervention on RMNPI index scores||"Null hypothesis:~The sequence of brushing and flossing has no effect on plaque scores~There were no previous studies with Mean and SD to calculate sample. So a pilot study was conducted. 30 participants were randomly assigned in 1:1 fashion to Brush-floss (GroupA) and Floss brush group (group B). Then after 1 week there was cross-over among the groups.2 groups would have at least 80% power to detect the mean difference in BPI scores."||3.219|-3.335|0.971
73858405|NCT03272828|147262511|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
73858406|NCT03272828|147262512|SUPERIORITY|||||||0.06|||||||Unequal-variance 2-sample t-test|||||||0.06
73858407|NCT03272828|147262513|SUPERIORITY|||||||0.45|||||||Unequal-variance 2-sample t-test|||||||0.45
73912530|NCT02100514|147354994|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-27.5|STANDARD_ERROR_OF_MEAN|3.23||||95.0|-33.9|-21.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-21.2|-33.9|
73912531|NCT02100514|147354994|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-49.4|STANDARD_ERROR_OF_MEAN|18.27|||TWO_SIDED|95.0|-85.2|-13.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.5|-85.2|
73912532|NCT02100514|147354995|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|5.5|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|3.4|7.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.6|3.4|<0.001
73912533|NCT02100514|147354995|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|5.4|STANDARD_ERROR_OF_MEAN|1.14||||95.0|3.2|7.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.6|3.2|
73912534|NCT02100514|147354995|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|6.0|STANDARD_ERROR_OF_MEAN|1.2||||95.0|3.6|8.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||8.3|3.6|
73912535|NCT02100514|147354996|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-44.2|STANDARD_ERROR_OF_MEAN|2.39||||95.0|-48.8|-39.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-39.5|-48.8|
74026724|NCT01287117|147607058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.34|||<|0.0001|TWO_SIDED|95.0|1.63|3.36||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||3.36|1.63|<0.0001
74026725|NCT01287117|147607059|SUPERIORITY_OR_OTHER|||||||0.0148||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.0148
74026726|NCT01287117|147607059|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||||<0.0001
74026727|NCT01287117|147607059|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
74085535|NCT02030535|147725021|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.252|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.22|0.284||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation.|Tiotropium 5μg + Olodaterol 5μg minus Placebo.|||0.284|0.220|<0.0001
74085536|NCT02030535|147725021|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.033|STANDARD_ERROR_OF_MEAN|0.016|||TWO_SIDED|95.0|-0.065|-0.001|||||Tio+Olo 5/5μg minus Tiotropium 5μg + Olodaterol 5μg.|Descriptive comparison. Statistical Analyses 1 \& 2 were included in the hierarchical testing sequence (alpha protected), and analysis 3 was not included in the hierarchical testing sequence (not alpha protected)||-0.001|-0.065|
73912536|NCT02100514|147354996|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-36.2|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-40.9|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-31.4|-40.9|
74026728|NCT01287117|147607060|SUPERIORITY_OR_OTHER|||||||0.0118||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.0118
73858408|NCT03777709|147262516|SUPERIORITY||Mean Difference (Final Values)|1.45|STANDARD_DEVIATION|2.0|<|0.0001|TWO_SIDED|||||unadjusted p-value|Regression, Linear||A recruitment aim of 40 participants per church (16 churches, 8 per arm, mean of 5 participants per church) provides 80% power to detect a difference of 1.45 in mean LS7 score change between groups (effect size 0.73).|Effect size of 1-unit difference in mean LS7 score was based on meta-analysis indicating each unit increase in mean LS7 metrics equates to a 19% and 11% reduction in CVD and all-cause mortality, respectively. Power calculations to estimate sample size: church goal of 16 churches (8/arm), with mean 5 participants/church (40/arm) to provide 80% power to detect 1.45 difference in average LS7 score change between groups (.01 intracluster correlation, and .5 coefficient of variation of church sizes).||||<0.0001
73858409|NCT03575065|147262543|SUPERIORITY|||||||0.021||||||p-value was based on an exact binomial test with historic control ORR=0.25|Exact Binomial Test|||||||0.0210
73858410|NCT06276881|147262612|SUPERIORITY|||||||0.37|||||||t-test, 1 sided||||Multiple regression analysis|||.37
73858411|NCT06276881|147262613|SUPERIORITY|||||||0.07|||||||ANOVA|||||||.07
73858412|NCT03664674|147262614|SUPERIORITY||Mean Difference (Net)|-0.221|STANDARD_ERROR_OF_MEAN|0.218||0.312|TWO_SIDED|95.0|-0.648|0.207||Generalized Linear Model - Negative Binomial Regression Model with count data by subject transformed using the log-link function.|Regression, Linear|The parameter estimate + conf. int. results back-transform to the ratio of adjusted mean DVDs (OTO-104/Placebo) to be 0.802 (0.523, 1.230).||||0.207|-0.648|0.312
73858413|NCT02780856|147262659|SUPERIORITY||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval||||<0.0001
73858414|NCT02780856|147262659|SUPERIORITY||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval||||<0.0001
73858415|NCT04762043|147262676|SUPERIORITY||Mean Difference (Final Values)|56.55|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|53.33|59.76|||Mixed Models Analysis|Effect size used for mixed effects model is partial eta-squared (ηp2).||||59.76|53.33|<.001
73858416|NCT03172884|147262694|OTHER||LS means|1.385|||||TWO_SIDED|90.0|0.921|2.081||||||Moderate Hepatic Impairment vs Healthy Subjects||2.081|0.921|
73858417|NCT03172884|147262694|OTHER||LS means|1.445|||||TWO_SIDED|90.0|0.998|2.093||||||Severe hepatic impairment group vs Healthy Subjects||2.093|0.998|
73858418|NCT03172884|147262694|OTHER||LS means|0.646|||||TWO_SIDED|90.0|0.486|0.858||||||Severe renal impairment group vs Healthy Subjects||0.858|0.486|
73858419|NCT03172884|147262695|OTHER||LS Means|1.711|||||TWO_SIDED|90.0|1.148|2.55||||||Moderate Hepatic Impairment group vs Healthy Subjects||2.550|1.148|
73858420|NCT03172884|147262695|OTHER||LS Means|2.705|||||TWO_SIDED|90.0|2.115|3.46||||||Severe hepatic impairment group vs Healthy Subjects||3.460|2.115|
73912537|NCT02100514|147354997|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.1|STANDARD_ERROR_OF_MEAN|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-5.1|-15.1|
73912538|NCT02100514|147354997|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-9.0|STANDARD_ERROR_OF_MEAN|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-17.9|
73858421|NCT03172884|147262695|OTHER||LS Means|1.075|||||TWO_SIDED|90.0|0.696|1.659||||||Severe renal impairment group vs Healthy Subjects||1.659|0.696|
74026729|NCT01287117|147607060|SUPERIORITY_OR_OTHER|||||||0.0226||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||||0.0226
73858422|NCT03172884|147262696|OTHER||LS Means|1.768|||||TWO_SIDED|90.0|1.251|2.498||||||Moderate Hepatic Impairment group vs Healthy Subjects||2.498|1.251|
73858423|NCT03172884|147262696|OTHER||LS Means|2.735|||||TWO_SIDED|90.0|2.163|3.459||||||Severe hepatic impairment group vs Healthy Subjects||3.459|2.163|
73858424|NCT03172884|147262696|OTHER||LS Means|1.124|||||TWO_SIDED|90.0|0.815|1.549||||||Severe renal impairment group vs Healthy Subjects||1.549|0.815|
73858425|NCT01468233|147262707|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|31.5|||<|0.001|TWO_SIDED|95.0|20.7|42.2||P-value adjusted for baseline Hurley Stage and for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||42.2|20.7|<0.001
73858426|NCT01468233|147262707|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|25.5|||<|0.001|TWO_SIDED|95.0|10.5|40.5||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||40.5|10.5|<0.001
73858427|NCT01468233|147262707|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|38.1|||<|0.001|TWO_SIDED|95.0|22.8|53.3||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||53.3|22.8|<0.001
73858428|NCT01468233|147262708|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|19.5|||=|0.01|TWO_SIDED|95.0|4.7|34.2||P-value adjusted for baseline antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||34.2|4.7|=0.01
73858429|NCT01468233|147262709|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|25.1|||<|0.001|TWO_SIDED|95.0|12.7|37.6||P-value adjusted for baseline Hurley Stage and antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||37.6|12.7|<0.001
73858430|NCT01468233|147262710|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.4|||<|0.001|TWO_SIDED|95.0|-28.6|-10.1||P-value calculated from ANCOVA with stratum (baseline Hurley Stage and antibiotics use), baseline value, and treatment as covariates.|ANCOVA|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||-10.1|-28.6|<0.001
73912539|NCT02100514|147354997|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-8.2|STANDARD_ERROR_OF_MEAN|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-2.2|-14.1|
73912540|NCT02100514|147354998|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|4.1|STANDARD_ERROR_OF_MEAN|0.85||||95.0|2.5|5.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||5.8|2.5|
73912541|NCT02100514|147354998|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|3.8|STANDARD_ERROR_OF_MEAN|0.86||||95.0|2.2|5.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||5.5|2.2|
73912542|NCT02100514|147354998|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|4.3|STANDARD_ERROR_OF_MEAN|0.97||||95.0|2.4|6.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.2|2.4|
73912543|NCT02100514|147354999|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|1.1|STANDARD_ERROR_OF_MEAN|0.9||||95.0|-0.7|2.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.8|-0.7|
73912544|NCT02100514|147354999|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|0.9|STANDARD_ERROR_OF_MEAN|1.04||||95.0|-1.1|3.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.0|-1.1|
73912545|NCT02100514|147354999|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|0.8|STANDARD_ERROR_OF_MEAN|0.95||||95.0|-1.0|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.7|-1.0|
73912546|NCT02100514|147355000|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.1|STANDARD_ERROR_OF_MEAN|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-5.1|-15.1|
74026730|NCT01287117|147607060|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
73912547|NCT02100514|147355000|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-9.0|STANDARD_ERROR_OF_MEAN|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-17.9|
73912548|NCT02100514|147355000|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-8.2|STANDARD_ERROR_OF_MEAN|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-2.2|-14.1|
73912549|NCT02100514|147355001|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.8|STANDARD_ERROR_OF_MEAN|3.18||||95.0|-73.0|-60.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-60.5|-73.0|
73912550|NCT02100514|147355002|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.1|STANDARD_ERROR_OF_MEAN|5.4||||95.0|-76.7|-55.4||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-55.4|-76.7|
73912551|NCT02100514|147355003|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.5|STANDARD_ERROR_OF_MEAN|2.77||||95.0|-72.0|-61.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-61.1|-72.0|
73912552|NCT02100514|147355004|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-69.1|STANDARD_ERROR_OF_MEAN|3.08||||95.0|-75.2|-63.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-63.1|-75.2|
73965227|NCT04059042|147465487|EQUIVALENCE|Between-session change scores were calculated per participant as Audio minus Silence and compared between groups with independent samples Mann-Whitney U-tests. Data were not normally distributed so nonparametric tests were used.|Z score|14.0||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
73912553|NCT02100514|147355005|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-71.3|STANDARD_ERROR_OF_MEAN|3.14||||95.0|-77.5|-65.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-65.1|-77.5|
73912554|NCT02100514|147355006|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-47.7|STANDARD_ERROR_OF_MEAN|2.12||||95.0|-51.9|-43.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.6|-51.9|
73912555|NCT02100514|147355007|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.4|STANDARD_ERROR_OF_MEAN|1.06||||95.0|-12.5|-8.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-8.3|-12.5|
73912556|NCT02100514|147355008|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|2.6|STANDARD_ERROR_OF_MEAN|0.52||||95.0|1.6|3.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.6|1.6|
73912557|NCT02100514|147355009|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.08||||95.0|-1.8|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.5|-1.8|
73912558|NCT02100514|147355009|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.1||||95.0|-1.6|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.3|-1.6|
73912559|NCT02100514|147355009|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.12||||95.0|-1.6|-1.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.2|-1.6|
73858431|NCT00457821|147262725|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
73858432|NCT00457821|147262726|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
73858433|NCT00457821|147262728|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
73858434|NCT01632241|147262730|SUPERIORITY||Odds Ratio (OR)|1.4||||0.1068|TWO_SIDED|95.0|0.93|2.11|||Regression, Logistic|||||2.11|0.93|0.1068
73858435|NCT01632241|147262739|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0937|TWO_SIDED|95.0|0.94|2.15||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic|||||2.15|0.94|0.0937
73858436|NCT01632241|147262741|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.2264|TWO_SIDED|95.0|0.51|1.17||Nominal p-value due to step-down sequential testing procedure.|Cox proportional hazards model|||||1.17|0.51|0.2264
73858437|NCT01632241|147262743|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4996|TWO_SIDED|95.0|0.61|2.8||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic|||||2.80|0.61|0.4996
73858438|NCT00835640|147262843|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|81.33||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
73858439|NCT00835640|147262844|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|87.87||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
73858440|NCT00835640|147262845|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|88.45||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
74026731|NCT01287117|147607061|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.34||||0.0124|TWO_SIDED|95.0|-4.17|-0.51||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||-0.51|-4.17|0.0124
74085537|NCT01362296|147725047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.5197|TWO_SIDED|95.0|0.75|1.75||P-value from the stratified log-rank was adjusted for gender (male versus female).|Log Rank||HRs were estimated using a Pike estimator. The HR from the stratified log-rank test was adjusted for gender (male versus female).|||1.75|0.75|0.5197
73965228|NCT02590432|147465509|SUPERIORITY||Odds Ratio (OR)|1.3||||1|TWO_SIDED|95.0|0.3|5.5|||Fisher's Exact Test|||LINZESS® 145 μg versus (vs) LINZESS® 290 μg||5.5|0.3|1.0000
73912560|NCT02100514|147355010|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.4|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.4|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.4|
73912561|NCT02100514|147355010|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
73912562|NCT02100514|147355010|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.4|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-0.4|
73912563|NCT02100514|147355011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.9||||||95.0|32.08|90.59||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||90.59|32.08|
73912564|NCT02100514|147355011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.0||||||95.0|11.15|26.07||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||26.07|11.15|
73912565|NCT02100514|147355011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.1||||||95.0|6.18|13.48||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||13.48|6.18|
73912566|NCT02100514|147355012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.4||||||95.0|48.84|501.11||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||501.11|48.84|
73912567|NCT02100514|147355012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|110.8||||||95.0|39.77|308.46||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||308.46|39.77|
73965229|NCT02590432|147465509|SUPERIORITY||Odds Ratio (OR)|0.2||||0.0844|TWO_SIDED|95.0|0.1|1.1|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg||1.1|0.1|0.0844
73912568|NCT02100514|147355012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|43.3||||||95.0|19.52|96.13||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||96.13|19.52|
74085538|NCT00401245|147725091|SUPERIORITY_OR_OTHER|||||||0.024||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).||||0.024
73863242|NCT02636946|147272687|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.29||0.0735|TWO_SIDED|95.0|-1.09|0.05|||MMRM|||Change from Baseline at Week 12: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||0.05|-1.09|0.0735
73912569|NCT00724932|147355019|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|3.4|||<|0.0001|TWO_SIDED|95.0|2.8|4.1||Testing was performed using a two-sided test at the 0.05 significance level. There was only one primary comparison, therefore no adjustment for multiplicity was required.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.9 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a two-way analysis of variance (ANOVA) model adjusted for treatment group and trial site.||4.1|2.8|<0.0001
73912570|NCT00724932|147355020|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|2.1|2.8||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.7 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.7 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.||2.8|2.1|<0.0001
73912571|NCT00724932|147355028|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|2.9|||<|0.0001|TWO_SIDED|95.0|2.5|3.4||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.8 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.8 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.||3.4|2.5|<0.0001
73912572|NCT02218320|147355055|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
73965230|NCT02590432|147465509|SUPERIORITY||Odds Ratio (OR)|0.9||||1|TWO_SIDED|95.0|0.3|2.5|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg||2.5|0.3|1.0000
73965231|NCT02590432|147465510|SUPERIORITY||Odds Ratio (OR)|1.3||||1|TWO_SIDED|95.0|0.3|5.1|||Fisher's Exact Test|||LINZESS® 145 μg vs LINZESS® 290 μg||5.1|0.3|1.0000
73965232|NCT02590432|147465510|SUPERIORITY||Odds Ratio (OR)|0.2||||0.0799|TWO_SIDED|95.0|0.1|1.0|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg||1.0|0.1|0.0799
73858441|NCT00068250|147262846|OTHER||||||||||||||||||Dose escalation followed the standard 3+3 design, although up to six patients could be accrued per dose level before suspending accrual for toxicity evaluation. If none of the first three patients (0/3), or one of the first three and none of the second three (1/3 and 0/3), experience a DLT, then the current dose level would be considered acceptable, and the next dose opened. Otherwise, the current dose level would be considered too toxic. The highest dose achieved with an acceptable level of toxicity was to considered the Maximum Tolerable Dose (MTD). If at any time a grade 5 toxicity was observed, accrual will be suspended, and the Study Chair would review the event. Furthermore, if the cumulative incidence (obtained by time to event analysis), at any time, of combined acute/late DLTs estimated the toxicity rate to be greater than 30% at any dose level, then the Executive Committee will be notified, and the committee would determine whether to stop accrual.|||
73858442|NCT00068250|147262847|SUPERIORITY|||||||0.006|||||||One-sample z-test|||Null hypothesis: Two-year survival rate \<= 64%; Alternative hypothesis: Two-year survival rate \> 64%. The fixed survival rate for comparison comes from Radiation Therapy Oncology Group (RTOG) trial 9310. (RTOG 9310 does not fall within ClinicalTrials.gov registration/reporting requirements.)||||0.006
73858443|NCT00068250|147262848|OTHER|||||||0.82|||||||Chi-squared|One-sample test of proportions||RTOG 93-10 reported a pre-irradiation chemotherapy complete response rate of 59%. A chi-square test with a 0.20 one-sided significance level provides 81% power to detect the difference between a null hypothesis complete response rate of 59% and the alternative rate of 71% (a 20% increase) for the planned sample size of 52 patients.||||0.82
73858444|NCT01686750|147262851|SUPERIORITY||Risk Ratio (RR)|1.31||||0.09|TWO_SIDED|95.0|0.95|1.81|||Prevalence ratio||Therefore, the exponentiated coefficients for intervention status represent the prevalence ratio with 95% confidence interval (CI) and are interpreted as the relative percentage difference in the outcome associated with the intervention.|We compared the sampling-weighted prevalence of outcomes at Integrated Care Centers (ICCs) and usual care from the evaluation survey. We used linear regression models that had terms for intervention status (integrated care vs usual care), stratum (PWID and MSM), and the baseline proportion of the outcome being assessed. Site-level proportions from both evaluation and baseline respondent-driven sampling were log transformed before being entered into the regression model.||1.81|0.95|0.09
73858445|NCT01686750|147262852|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.8|1.5||||||||1.50|0.80|
73858446|NCT01686750|147262853|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.61|1.81||||||||1.81|0.61|
73858447|NCT01686750|147262854|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.77|2.41||||||||2.41|0.77|
73858448|NCT01686750|147262856|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.28||||||||1.28|0.65|
73858449|NCT01686750|147262858|SUPERIORITY||Risk Ratio, log|1.44|||||TWO_SIDED|95.0|0.42|4.93||||||||4.93|0.42|
73858450|NCT01686750|147262859|SUPERIORITY||Risk Ratio, log|1.87|||||TWO_SIDED|95.0|0.49|7.16||||||||7.16|0.49|
73858451|NCT01686750|147262860|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.53|1.56||||||||1.56|0.53|
73858452|NCT01686750|147262861|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-4.2|4.2||||||||4.2|-4.2|
73858453|NCT01686750|147262863|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.47|1.52||||||||1.52|0.47|
73858454|NCT01686750|147262865|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-3.0|-0.6||||||||-0.6|-3.0|
73858455|NCT01686750|147262866|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.64|1.36||||||||1.36|0.64|
73912573|NCT04203498|147355058|SUPERIORITY||Difference in least squares means|-0.73|STANDARD_ERROR_OF_MEAN|0.914|=|0.4263|TWO_SIDED|95.0|-2.54|1.08|||Linear mixed model repeated measures|||Week 9 to 12 (primary outcome statistics)||1.08|-2.54|=0.4263
73912574|NCT04010695|147355079|OTHER||||||<|0.001|||||||K-sample test|The p-value was calculated using a nonparametric k-sample test on the equality of medians.||Comparison of SD Biosensor POC G6PD test results for capillary and venous samples||||<0.001
73858456|NCT01939002|147262870|SUPERIORITY_OR_OTHER||||||<|0.0001||||||1-sample Chi-square test comparing to Null hypotheses at 25%.|Chi-squared|||||||<0.0001
73858457|NCT01939002|147262871|SUPERIORITY_OR_OTHER|||||||0.2037||||||Chi-square test between 2 treatment arms.|Chi-squared|||||||0.2037
73858458|NCT01939002|147262873|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|McNemar tests the null hypothesis of no difference in FLS between 4WRI and F8W.||||||1.00
73858459|NCT01939002|147262873|SUPERIORITY_OR_OTHER|||||||0.5078|||||||McNemar|||||||0.5078
73858460|NCT01939002|147262873|SUPERIORITY_OR_OTHER|||||||0.5811|||||||McNemar|||||||0.5811
73858461|NCT01939002|147262874|SUPERIORITY_OR_OTHER|||||||0.0525|||||||McNemar|||||||0.0525
73858462|NCT01939002|147262874|SUPERIORITY_OR_OTHER|||||||0.0654|||||||McNemar|||||||0.0654
73858463|NCT01939002|147262874|SUPERIORITY_OR_OTHER|||||||0.5488|||||||McNemar|||||||0.5488
73858464|NCT01939002|147262875|SUPERIORITY_OR_OTHER|||||||0.0945|||||||paired t-test within 1 arm|||||||0.0945
73858465|NCT01939002|147262875|SUPERIORITY_OR_OTHER|||||||0.8246|||||||paired t-test within 1 arm|||||||0.8246
73858466|NCT01939002|147262875|SUPERIORITY_OR_OTHER|||||||0.2533|||||||paired t-test within 1 arm|||||||0.2533
73858467|NCT01939002|147262875|SUPERIORITY_OR_OTHER|||||||0.1631|||||||2-sample t-test between 2 arms|||||||0.1631
73858468|NCT01939002|147262876|SUPERIORITY_OR_OTHER|||||||0.3189|||||||paired t-test within 1 arm|||||||0.3189
73858469|NCT01939002|147262876|SUPERIORITY_OR_OTHER|||||||0.3582|||||||paired t-test within 1 arm|||||||0.3582
73858470|NCT01939002|147262876|SUPERIORITY_OR_OTHER|||||||0.8484|||||||paired t-test within 1 arm|||||||0.8484
73858471|NCT01939002|147262876|SUPERIORITY_OR_OTHER|||||||0.1771|||||||2-sample t-test between 2 arms|||||||0.1771
73858472|NCT01939002|147262877|SUPERIORITY_OR_OTHER|||||||0.0009|||||||paired t-test within 1 arm|||||||0.0009
73858473|NCT01939002|147262877|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
73858474|NCT01939002|147262877|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
73912575|NCT01235689|147355080|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by Screening smoking status (yes or no) and weight (\< 70 kg or ≥ 70 kg).||||||0.010
73912576|NCT01235689|147355081|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.014
73912577|NCT01235689|147355082|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.006
73912578|NCT01235689|147355083|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.010
73912579|NCT01235689|147355084|SUPERIORITY|||||||0.299|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.299
73912580|NCT01235689|147355085|SUPERIORITY|||||||0.728|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.728
73912581|NCT01235689|147355086|SUPERIORITY|||||||0.067|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.067
73912582|NCT01235689|147355087|SUPERIORITY||LS Mean Difference|-1.4||||0.116|TWO_SIDED|95.0|-3.2|0.4|||ANCOVA|Model included factors for treatment group, screening smoking status (yes or no), and weight (\< 70 kg, ≥ 70 kg), and Baseline values as covariate.||||0.4|-3.2|0.116
73912583|NCT01235689|147355089|SUPERIORITY||Cox Proportional Hazard|0.442||||0.012|TWO_SIDED|95.0|0.2|0.8|||Regression, Cox|||||0.8|0.2|0.012
73912584|NCT01235689|147355090|SUPERIORITY||Cox Proportional Hazard|1.45||||0.008|TWO_SIDED|95.0|1.1|1.9|||Regression, Cox|||||1.9|1.1|0.008
73858475|NCT01939002|147262877|SUPERIORITY_OR_OTHER|||||||0.3792|||||||2-sample t-test between 2 arms|||||||0.3792
73858476|NCT01939002|147262878|SUPERIORITY_OR_OTHER|||||||0.0019|||||||paired t-test within 1 arm|||||||0.0019
73858477|NCT01939002|147262878|SUPERIORITY_OR_OTHER|||||||0.0009|||||||paired t-test within 1 arm|||||||0.0009
73858478|NCT01939002|147262878|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
73858479|NCT01939002|147262879|SUPERIORITY_OR_OTHER|||||||0.0105|||||||paired t-test within 1 arm|||||||0.0105
73858480|NCT01939002|147262879|SUPERIORITY_OR_OTHER|||||||0.0789|||||||paired t-test within 1 arm|||||||0.0789
73858481|NCT01939002|147262879|SUPERIORITY_OR_OTHER|||||||0.0027|||||||paired t-test within 1 arm|||||||0.0027
73858482|NCT01939002|147262879|SUPERIORITY_OR_OTHER|||||||0.838|||||||2-sample t-test between 2 arms|||||||0.8380
73858483|NCT01939002|147262880|SUPERIORITY_OR_OTHER|||||||0.1407|||||||paired t-test within 1 arm|||||||0.1407
73858484|NCT01939002|147262880|SUPERIORITY_OR_OTHER|||||||0.7805|||||||paired t-test within 1 arm|||||||0.7805
73858485|NCT01939002|147262880|SUPERIORITY_OR_OTHER|||||||0.2186|||||||paired t-test within 1 arm|||||||0.2186
73858486|NCT01939002|147262880|SUPERIORITY_OR_OTHER|||||||0.4234|||||||2-sample t-test between 2 arms|||||||0.4234
73858487|NCT01939002|147262881|SUPERIORITY_OR_OTHER|||||||0.009|||||||paired t-test within 1 arm|||||||0.0090
73858488|NCT01939002|147262881|SUPERIORITY_OR_OTHER|||||||0.0075|||||||paired t-test within 1 arm|||||||0.0075
73858489|NCT01939002|147262881|SUPERIORITY_OR_OTHER|||||||0.0002|||||||paired t-test within 1 arm|||||||0.0002
73858490|NCT01939002|147262881|SUPERIORITY_OR_OTHER|||||||0.7497|||||||2-sample t-test between 2 arms|||||||0.7497
73858491|NCT01939002|147262882|SUPERIORITY_OR_OTHER|||||||0.0545|||||||paired t-test within 1 arm|||||||0.0545
73858492|NCT01939002|147262882|SUPERIORITY_OR_OTHER|||||||0.3377|||||||paired t-test within 1 arm|||||||0.3377
73858493|NCT01939002|147262882|SUPERIORITY_OR_OTHER|||||||0.0391|||||||paired t-test within 1 arm|||||||0.0391
73858494|NCT01939002|147262882|SUPERIORITY_OR_OTHER|||||||0.4861|||||||2-sample t-test between 2 arms|||||||0.4861
73858495|NCT01939002|147262883|SUPERIORITY_OR_OTHER|||||||0.0834|||||||Fisher Exact|||first 8 weeks||||0.0834
73858496|NCT01939002|147262883|SUPERIORITY_OR_OTHER|||||||0.0767|||||||Fisher Exact|||Weeks 0-2||||0.0767
73858497|NCT01939002|147262883|SUPERIORITY_OR_OTHER|||||||0.732|||||||Fisher Exact|||Weeks 3-4||||0.7320
73858498|NCT01939002|147262883|SUPERIORITY_OR_OTHER|||||||0.5008|||||||Fisher Exact|||Weeks 5-6||||0.5008
73858499|NCT01939002|147262883|SUPERIORITY_OR_OTHER|||||||0.6422|||||||Fisher Exact|||Weeks 7-8||||0.6422
73858500|NCT01939002|147262884|SUPERIORITY_OR_OTHER|||||||0.2123|||||||paired t-test within 1 arm|||change at Week 4||||0.2123
73912585|NCT01235689|147355091|SUPERIORITY||Cox Proportional Hazard|1.337||||0.052|TWO_SIDED|95.0|1.0|1.8|||Regression, Cox|||||1.8|1.0|0.052
73912586|NCT01235689|147355094|SUPERIORITY||Cox Proportional Hazard|0.823||||0.501|TWO_SIDED|95.0|0.5|1.5|||Regression, Cox|||||1.5|0.5|0.501
73912587|NCT01235689|147355095|SUPERIORITY||Cox Proportional Hazard|0.785||||0.459|TWO_SIDED|95.0|0.4|1.5|||Regression, Cox|||||1.5|0.4|0.459
73912588|NCT01235689|147355102|SUPERIORITY||Cox Proportional Hazard|0.423||||0.212|TWO_SIDED|95.0|0.1|1.6|||Regression, Cox|||||1.6|0.1|0.212
73912589|NCT00389597|147355118|NON_INFERIORITY_OR_EQUIVALENCE|The 95% one-sided confidence bound for testing non-inferiority using two proportion test with 10% non-inferiority margin.||||||0.0021|||||||Farrington Manning|||1 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.||||0.0021
73912590|NCT00389597|147355118|NON_INFERIORITY_OR_EQUIVALENCE|The 95% one-sided confidence bound for testing non-inferiority using two proportioned test with a 10% non-inferiority margin.|||||<|0.0001|||||||Farrington-Manning|||"2 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.~2 Level: Ho: pm-pc \<= 0 (not superior) Alternative hypothesis: Ha: pm-pc \>0 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group."||||<0.0001
73912591|NCT00087607|147355147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.978|TWO_SIDED|95.0|-0.35|0.36|||t-test, 2 sided|||Mean treatment difference was tested using a two-sided t-test.||0.36|-0.35|0.978
73912592|NCT00087607|147355148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.08|TWO_SIDED|95.0|-0.03|0.58|||t-test, 2 sided|||At Week 4: Mean treatment difference was tested using a two-sided t-test.||0.58|-0.03|0.080
73912593|NCT00087607|147355148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.688|TWO_SIDED|95.0|-0.27|0.41|||t-test, 2 sided|||At Week 8: Mean treatment difference was tested using a two-sided t-test.||0.41|-0.27|0.688
73912594|NCT00087607|147355152|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED||||||ANOVA|||The treatment groups were compared using an analysis of variance (ANOVA) with treatment as the only factor in the model.||||0.304
73912595|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.1||||0.2814|TWO_SIDED|95.0|-8.6|2.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.||2.5|-8.6|0.2814
74085539|NCT00401245|147725092|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, analysis of variance (ANOVA) was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||< 0.001
73858501|NCT01939002|147262884|SUPERIORITY_OR_OTHER|||||||0.5834|||||||paired t-test within 1 arm|||change at Week 12||||0.5834
73858502|NCT01939002|147262884|SUPERIORITY_OR_OTHER|||||||0.8723|||||||paired t-test within 1 arm|||change at Week 24||||0.8723
73858503|NCT01939002|147262884|SUPERIORITY_OR_OTHER|||||||0.4173|||||||paired t-test within 1 arm|||change at Week 36||||0.4173
73858504|NCT01939002|147262884|SUPERIORITY_OR_OTHER|||||||0.2267|||||||paired t-test within 1 arm|||change at Week 48||||0.2267
73858505|NCT01939002|147262884|SUPERIORITY_OR_OTHER|||||||0.0171|||||||paired t-test within 1 arm|||change at Early Term||||0.0171
73912596|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-10.3||||0.0214|TWO_SIDED|95.0|-18.9|-1.6|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.||-1.6|-18.9|0.0214
73912597|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-10.7||||0.0315|TWO_SIDED|95.0|-20.3|-1.0|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.||-1.0|-20.3|0.0315
73858506|NCT01939002|147262885|SUPERIORITY_OR_OTHER|||||||0.0001|||||||paired t-test within 1 arm|||change at Week 4||||0.0001
74026732|NCT01287117|147607061|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.16||||0.0012|TWO_SIDED|95.0|-5.05|-1.27||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.27|-5.05|0.0012
73858507|NCT01939002|147262885|SUPERIORITY_OR_OTHER|||||||0.0007|||||||paired t-test within 1 arm|||change at Week 12||||0.0007
73858508|NCT01939002|147262885|SUPERIORITY_OR_OTHER|||||||0.0365|||||||paired t-test within 1 arm|||change at Week 24||||0.0365
73858509|NCT01939002|147262885|SUPERIORITY_OR_OTHER|||||||0.0197|||||||paired t-test within 1 arm|||change at Week 36||||0.0197
73912598|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-7.4||||0.1467|TWO_SIDED|95.0|-17.4|2.6|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.||2.6|-17.4|0.1467
74026733|NCT01287117|147607061|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.73|||<|0.0001|TWO_SIDED|95.0|-7.59|-3.87||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.87|-7.59|<0.0001
74026734|NCT01287117|147607062|SUPERIORITY_OR_OTHER||Least squares mean difference|0.26||||0.7956|TWO_SIDED|95.0|-1.76|2.28||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||2.28|-1.76|0.7956
74026735|NCT01287117|147607062|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.31||||0.2286|TWO_SIDED|95.0|-3.46|0.84||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||0.84|-3.46|0.2286
74026736|NCT01287117|147607062|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.08|||<|0.0001|TWO_SIDED|95.0|-5.96|-2.2||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-2.20|-5.96|<0.0001
74085540|NCT00401245|147725092|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||<0.001
73912599|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.8||||0.1823|TWO_SIDED|95.0|-16.9|3.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.||3.2|-16.9|0.1823
73858510|NCT01939002|147262885|SUPERIORITY_OR_OTHER|||||||0.4031|||||||paired t-test within 1 arm|||change at Week 48||||0.4031
73858511|NCT01939002|147262885|SUPERIORITY_OR_OTHER|||||||0.006|||||||paired t-test within 1 arm|||change at Early Termination||||0.0060
73858512|NCT01939002|147262886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
73858513|NCT01939002|147262886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12||||<0.0001
73858514|NCT01939002|147262886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24||||<0.0001
73858515|NCT01939002|147262886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36||||<0.0001
73858516|NCT01939002|147262886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48||||<0.0001
73858517|NCT01939002|147262886|SUPERIORITY_OR_OTHER|||||||0.1789|||||||paired t-test within 1 arm|||change at Early Termination||||0.1789
73858518|NCT01939002|147262886|SUPERIORITY_OR_OTHER|||||||0.2248||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.2248
73858519|NCT01939002|147262887|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
73858520|NCT01939002|147262887|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12||||<0.0001
73858521|NCT01939002|147262887|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24||||<0.0001
73858522|NCT01939002|147262887|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36||||<0.0001
73858523|NCT01939002|147262887|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48||||<0.0001
73912600|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-2.1||||0.6871|TWO_SIDED|95.0|-12.1|8.0|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.||8.0|-12.1|0.6871
73912601|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-0.4||||0.9295|TWO_SIDED|95.0|-10.4|9.5|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.||9.5|-10.4|0.9295
73912602|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.2||||0.6593|TWO_SIDED|95.0|-7.6|12.1|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.||12.1|-7.6|0.6593
73912603|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.2||||0.6637|TWO_SIDED|95.0|-7.7|12.1|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.||12.1|-7.7|0.6637
73912604|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|5.4||||0.276|TWO_SIDED|95.0|-4.3|15.1|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.||15.1|-4.3|0.2760
73912605|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|5.4||||0.2779|TWO_SIDED|95.0|-4.3|15.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.||15.1|-4.3|0.2779
73858524|NCT01939002|147262887|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Early Termination||||<0.0001
73858525|NCT01939002|147262887|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||<0.0001
73858526|NCT01939002|147262888|SUPERIORITY_OR_OTHER|||||||0.7012|||||||paired t-test within 1 arm|||change at Week 4||||0.7012
73858527|NCT01939002|147262888|SUPERIORITY_OR_OTHER|||||||0.0548|||||||paired t-test within 1 arm|||change at Week 4||||0.0548
73858528|NCT01939002|147262888|SUPERIORITY_OR_OTHER|||||||0.0782|||||||2-sample t-test between 2 arms|||change at Week 4||||0.0782
73858529|NCT01939002|147262889|SUPERIORITY_OR_OTHER|||||||0.0006|||||||paired t-test within 1 arm|||change at Week 4||||0.0006
73858530|NCT01939002|147262889|SUPERIORITY_OR_OTHER|||||||0.0792|||||||paired t-test within 1 arm|||change at Week 4||||0.0792
73858531|NCT01939002|147262889|SUPERIORITY_OR_OTHER|||||||0.0961|||||||2-sample t-test between 2 arms|||change at Week 4||||0.0961
73858532|NCT01939002|147262890|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
73858533|NCT01939002|147262890|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
73858534|NCT01939002|147262890|SUPERIORITY_OR_OTHER|||||||0.4973|||||||2-sample t-test between 2 arms|||change at Week 4||||0.4973
73858535|NCT01939002|147262891|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
73858536|NCT01939002|147262891|SUPERIORITY_OR_OTHER|||||||0.0464|||||||paired t-test within 1 arm|||change at Week 4||||0.0464
73858537|NCT01939002|147262891|SUPERIORITY_OR_OTHER|||||||0.1905|||||||2-sample t-test between 2 arms|||change at Week 4||||0.1905
73858538|NCT01939002|147262892|SUPERIORITY_OR_OTHER|||||||0.6569|||||||paired t-test within 1 arm|||change at Week 12||||0.6569
73858539|NCT01939002|147262892|SUPERIORITY_OR_OTHER|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 24||||0.1584
73912606|NCT00087607|147355154|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.8||||0.5697|TWO_SIDED|95.0|-6.8|12.4|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.||12.4|-6.8|0.5697
73912607|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|0.0||||0.994|TWO_SIDED|95.0|-1.4|1.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.||1.5|-1.4|0.9940
73912608|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-0.5||||0.7133|TWO_SIDED|95.0|-3.2|2.2|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.||2.2|-3.2|0.7133
73912609|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.6||||0.0864|TWO_SIDED|95.0|-7.8|0.5|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.||0.5|-7.8|0.0864
73912610|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.1||||0.1713|TWO_SIDED|95.0|-10.0|1.8|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.||1.8|-10.0|0.1713
73912611|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.6||||0.1888|TWO_SIDED|95.0|-11.4|2.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.||2.2|-11.4|0.1888
73912612|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.6||||0.108|TWO_SIDED|95.0|-14.7|1.4|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.||1.4|-14.7|0.1080
73858540|NCT01939002|147262892|SUPERIORITY_OR_OTHER|||||||0.5106|||||||paired t-test within 1 arm|||change at Week 36||||0.5106
73858541|NCT01939002|147262892|SUPERIORITY_OR_OTHER|||||||0.5927|||||||paired t-test within 1 arm|||change at Week 48||||0.5927
73858542|NCT01939002|147262892|SUPERIORITY_OR_OTHER|||||||0.384|||||||paired t-test within 1 arm|||change at Early Termination||||0.3840
74085541|NCT00401245|147725092|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||<0.001
73858543|NCT01939002|147262892|SUPERIORITY_OR_OTHER|||||||0.4182||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.4182
73858544|NCT01939002|147262893|SUPERIORITY_OR_OTHER|||||||0.2588|||||||paired t-test within 1 arm|||change at Week 12||||0.2588
73858545|NCT01939002|147262893|SUPERIORITY_OR_OTHER|||||||0.1092|||||||paired t-test within 1 arm|||change at Week 24||||0.1092
73858546|NCT01939002|147262893|SUPERIORITY_OR_OTHER|||||||1|||||||paired t-test within 1 arm|||change at Week 36||||1.0000
73858547|NCT01939002|147262893|SUPERIORITY_OR_OTHER|||||||0.219|||||||paired t-test within 1 arm|||change at Week 48||||0.2190
73858548|NCT01939002|147262893|SUPERIORITY_OR_OTHER|||||||0.6402||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.6402
73858549|NCT01939002|147262894|SUPERIORITY_OR_OTHER|||||||0.4821|||||||paired t-test within 1 arm|||change at Week 12||||0.4821
73858550|NCT01939002|147262894|SUPERIORITY_OR_OTHER|||||||0.5298|||||||paired t-test within 1 arm|||change at Week 24||||0.5298
73858551|NCT01939002|147262894|SUPERIORITY_OR_OTHER|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 36||||0.1584
73858552|NCT01939002|147262894|SUPERIORITY_OR_OTHER|||||||0.2547|||||||paired t-test within 1 arm|||change at Week 48||||0.2547
73858553|NCT01939002|147262894|SUPERIORITY_OR_OTHER|||||||0.0824|||||||paired t-test within 1 arm|||change at Early Termination||||0.0824
73858554|NCT01939002|147262894|SUPERIORITY_OR_OTHER|||||||0.3148||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model|||||||0.3148
73858555|NCT01939002|147262895|SUPERIORITY_OR_OTHER|||||||0.6508|||||||paired t-test within 1 arm|||change at Week 12||||0.6508
73858556|NCT01939002|147262895|SUPERIORITY_OR_OTHER|||||||0.0315|||||||paired t-test within 1 arm|||change at Week 48||||0.0315
73858557|NCT01939002|147262895|SUPERIORITY_OR_OTHER|||||||0.119|||||||paired t-test within 1 arm|||change at Early Termination||||0.1190
73858558|NCT01939002|147262895|SUPERIORITY_OR_OTHER|||||||0.152||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model|||||||0.1520
73858559|NCT01939002|147262897|SUPERIORITY_OR_OTHER|||||||0.0049|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.0049
73858560|NCT01939002|147262897|SUPERIORITY_OR_OTHER|||||||0.223|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.2230
73858561|NCT01939002|147262897|SUPERIORITY_OR_OTHER|||||||0.0031|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.0031
73858562|NCT01939002|147262897|SUPERIORITY_OR_OTHER|||||||0.1624|||||||2-sample t-test between 2 arms|||Change from 4WRI to L4W||||0.1624
73858563|NCT02499900|147262913|SUPERIORITY||Mean Difference (Final Values)|0.321|||<|0.001|TWO_SIDED|95.0|0.1615|0.4814||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: MSQ=baseline MSQ score+treatment+visit+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as MSQ is not measured at baseline for these patients.||0.4814|0.1615|<0.001
73858564|NCT02499900|147262914|SUPERIORITY||Mean Difference (Final Values)|9.448|||<|0.001|TWO_SIDED|95.0|6.9538|11.9429||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: TSQM-9 convenience score=baseline TSQM-9 convenience score+treatment+CGR+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as TSQM-9 is not measured at baseline for these patients.||11.9429|6.9538|<0.001
73858565|NCT02499900|147262915|SUPERIORITY||Mean Difference (Final Values)|-0.802||||0.208|TWO_SIDED|95.0|-2.05|0.4461||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.4461|-2.0500|0.208
73858566|NCT02499900|147262915|SUPERIORITY||Mean Difference (Final Values)|-0.231||||0.47|TWO_SIDED|95.0|-0.8588|0.3962||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Physical Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.3962|-0.8588|0.470
73858567|NCT02499900|147262915|SUPERIORITY||Mean Difference (Final Values)|-0.639||||0.043|TWO_SIDED|95.0|-1.2564|-0.0214||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Cognitive Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||-0.0214|-1.2564|0.043
73858568|NCT02499900|147262915|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.237|TWO_SIDED|95.0|-0.0672|0.2711||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Psychosocial Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.2711|-0.0672|0.237
73858569|NCT02499900|147262916|SUPERIORITY||Mean Difference (Final Values)|0.706||||0.287|TWO_SIDED|95.0|-0.5947|1.0074||0.05 level of significance|Repeated Measures ANCOVA|||Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.0074|-0.5947|0.287
73912613|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.5||||0.3099|TWO_SIDED|95.0|-13.1|4.2|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.||4.2|-13.1|0.3099
73912614|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.4||||0.4595|TWO_SIDED|95.0|-12.4|5.6|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.||5.6|-12.4|0.4595
73912615|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.0||||0.2144|TWO_SIDED|95.0|-15.4|3.4|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.||3.4|-15.4|0.2144
73912616|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-5.4||||0.2779|TWO_SIDED|95.0|-15.1|4.3|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.||4.3|-15.1|0.2779
73912617|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-2.7||||0.5876|TWO_SIDED|95.0|-12.6|7.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.||7.1|-12.6|0.5876
73912618|NCT00087607|147355155|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.8||||0.3399|TWO_SIDED|95.0|-14.7|5.1|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.||5.1|-14.7|0.3399
73912619|NCT00087607|147355160|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Repeated measures analysis|The P-value is determined from a repeated measures analysis with terms for treatment group, baseline, week, and the week-by-treatment interaction.||Week 1: The treatment groups were compared using repeated measures analysis||||0.024
73912620|NCT00087607|147355160|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Repeated measures analysis|||Week 8: The treatment groups were compared using Repeated measures analysis||||<0.001
73912621|NCT02015754|147355170|OTHER|||||||0.004||||||Differences of p-value \< 0.05 considered statistically significant.|Regression, Cox|||Multivariate Cox-regression analysis to identify independent prognostic factors for overall survival from baseline characteristics. Relative risk with 95% confidence intervals calculated as measure of association.||||0.004
73912622|NCT02015754|147355177|OTHER|VEGF immediately post treatment||||||0.6257|||||||one-sample Wilcoxon signed rank test|||||||0.6257
73912623|NCT02015754|147355177|OTHER|VEGF at 24 hours post treatment.||||||0.4143|||||||one-sample Wilcoxon signed rank test|||||||0.4143
73965233|NCT02590432|147465510|SUPERIORITY||Odds Ratio (OR)|0.7||||0.7871|TWO_SIDED|95.0|0.3|2.2|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg||2.2|0.3|0.7871
74026737|NCT01287117|147607063|SUPERIORITY_OR_OTHER|||||||0.4867||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.4867
74026738|NCT01287117|147607063|SUPERIORITY_OR_OTHER|||||||0.1747||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.1747
73912624|NCT02015754|147355177|OTHER|VEGFR1 immediately post treatment.||||||0.583|||||||one-sample Wilcoxon signed rank test|||||||0.583
73912625|NCT02015754|147355177|OTHER|VEGFR1 at 24 hours post treatment.||||||0.0012|||||||one-sample Wilcoxon signed rank test|||||||.0012
73912626|NCT02015754|147355177|OTHER|VEGFR2 immediately post treatment.||||||0.1353|||||||one-sample Wilcoxon signed rank test|||||||0.1353
73912627|NCT02015754|147355177|OTHER|VEGFR2 at 24 hours post treatment.||||||0.2163|||||||one-sample Wilcoxon signed rank test|||||||0.2163
73912628|NCT02516046|147355182|OTHER||Fleiss' kappa|0.8|||||TWO_SIDED|95.0|0.74|0.86||||||Inter-reader agreement analysis using Fleiss' kappa. The hypothesis tested was that the observed kappa values were ≥0.64 and the lower bound of the 2-sided 95% CIs were ≥0.55 for the inter-reader agreement among readers.||0.86|0.74|
73912629|NCT03137537|147355201|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73912630|NCT03137537|147355202|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
73912631|NCT03338010|147355205|NON_INFERIORITY|0.40% noninferiority margin was used.|LS Mean Difference|-0.05||||0.545|TWO_SIDED|95.0|-0.19|0.1|||Mixed Models Analysis|||||0.10|-0.19|0.545
73912632|NCT03338010|147355206|NON_INFERIORITY|0.40% noninferiority margin was used.|LS Mean Difference|-0.05||||0.545|TWO_SIDED|95.0|-0.19|0.1|||Mixed Models Analysis|||||0.10|-0.19|0.545
73912633|NCT03338010|147355207|SUPERIORITY||LS Mean Difference|1.0||||0.602|TWO_SIDED|95.0|-2.8|4.8|||Mixed Models Analysis|||Before Morning Meal Glucose||4.8|-2.8|0.602
73912634|NCT03338010|147355207|SUPERIORITY||LS Mean Difference|-3.7||||0.373|TWO_SIDED|95.0|-11.8|4.4|||Mixed Models Analysis|||2 Hours After Morning Meal Glucose||4.4|-11.8|0.373
73912635|NCT03338010|147355207|SUPERIORITY||LS Mean Difference|-3.3||||0.351|TWO_SIDED|95.0|-10.3|3.7|||Mixed Models Analysis|||Before Mid-Day Meal Glucose||3.7|-10.3|0.351
73912636|NCT03338010|147355207|SUPERIORITY||LS Mean Difference|4.9||||0.23|TWO_SIDED|95.0|-3.1|12.8|||Mixed Models Analysis|||2 Hours After Mid-Day Meal Glucose||12.8|-3.1|0.230
73912637|NCT03338010|147355207|SUPERIORITY||LS Mean Difference|0.9||||0.819|TWO_SIDED|95.0|-6.7|8.5|||Mixed Models Analysis|||Before Evening Meal Glucose||8.5|-6.7|0.819
73912638|NCT03338010|147355207|SUPERIORITY||LS Mean Difference|2.3||||0.588|TWO_SIDED|95.0|-6.2|10.9|||Mixed Models Analysis|||2 Hours After Evening Meal Glucose||10.9|-6.2|0.588
73965234|NCT02590432|147465512|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.993|TWO_SIDED|95.0|0.42|2.19|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg||2.19|0.42|0.9930
73965235|NCT02590432|147465512|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.0247|TWO_SIDED|95.0|0.11|0.89|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg||0.89|0.11|0.0247
73965236|NCT02590432|147465512|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.5149|TWO_SIDED|95.0|0.41|1.5|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg||1.50|0.41|0.5149
73965237|NCT02590432|147465513|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.9519|TWO_SIDED|95.0|0.39|2.18|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg||2.18|0.39|0.9519
74085542|NCT00401245|147725093|SUPERIORITY_OR_OTHER|||||||0.092||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.092
73858570|NCT02499900|147262916|SUPERIORITY||Mean Difference (Final Values)|0.141||||0.868|TWO_SIDED|95.0|-1.5179|1.7991||0.05 level of significance|Repeated Measures ANCOVA|||Anxiety subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.7991|-1.5179|0.868
73858571|NCT02499900|147262916|SUPERIORITY||Mean Difference (Final Values)|0.481||||0.544|TWO_SIDED|95.0|-1.0734|2.0348||0.05 level of significance|Repeated Measures ANCOVA|||Depression subscale estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||2.0348|-1.0734|0.544
73858572|NCT02499900|147262916|SUPERIORITY||Mean Difference (Final Values)|1.867||||0.014|TWO_SIDED|95.0|0.3843|3.3487||0.05 level of significance|Repeated Measures ANCOVA|||Behavioral Control subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||3.3487|0.3843|0.014
73858573|NCT02499900|147262916|SUPERIORITY||Mean Difference (Final Values)|-0.092||||0.919|TWO_SIDED|95.0|-1.8565|1.6728||0.05 level of significance|Repeated Measures ANCOVA|||MHI Positive Affect subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.6728|-1.8565|0.919
73858574|NCT02499900|147262917|SUPERIORITY||Mean Difference (Final Values)|-0.059||||0.851|TWO_SIDED|95.0|-0.6777|0.5592||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline BDI-II total score=baseline BDI-II total score+treatment+visit+country/geographic region +treatment by visit interaction.||0.5592|-0.6777|0.851
73858575|NCT03385265|147262919|SUPERIORITY||partial eta squared|0.02|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73858576|NCT03385265|147262920|SUPERIORITY||partial eta squared|0.12|||||TWO_SIDED||||||repeated measures ANOVA|CESD-R = within subject variable; group = between subject variable||||||
73858577|NCT03385265|147262921|SUPERIORITY||partial eta squared|0.03|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73858578|NCT03385265|147262922|SUPERIORITY||partial eta squared|0.06|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73858579|NCT03385265|147262923|SUPERIORITY||partial eta squared|0.04|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73858580|NCT03385265|147262924|SUPERIORITY||partial eta squared|0.04|||<|0.05|TWO_SIDED||||||repeated measures ANOVA|||||||<0.05
73858581|NCT03385265|147262925|SUPERIORITY||partial eta squared|0.24|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73858582|NCT03385265|147262926|SUPERIORITY||partial eta squared|0.03|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73858583|NCT03385265|147262927|SUPERIORITY||partial eta squared|0.04|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73858584|NCT03998670|147262932|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.5|1.1|||||Difference in mean control and 95% confidence interval (CI) are from ANCOVA model adjusting for corresponding baseline control score. Prism group minus Non-Prism group (positive difference indicates Prism group worse than Non-Prism group).|The primary analysis was the treatment group difference (and 95% CI) in mean distance control at the 8-week outcome visit using an ANCOVA adjusted for baseline distance control. The planned convenience sample size of 64 was expected to provide outcome data for at least 60 participants (30 per group).||1.1|-0.5|
73858585|NCT03998670|147262933|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-17.0|32.0|||||Difference between Prism minus Non-Prism group (positive difference indicates Prism group better than Non-Prism group).|||32|-17|
73858586|NCT03998670|147262934|SUPERIORITY||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-27.0|19.0|||||Difference between Prism minus Non-Prism group (positive difference indicates Prism group better than Non-Prism group).|||19|-27|
73858587|NCT03998670|147262936|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.7|0.7|||||Difference in mean control and 95% confidence interval (CI) are from ANCOVA model adjusting for corresponding baseline control score. Prism group minus Non-Prism group (positive difference indicates Prism group worse than Non-Prism group).|The secondary analysis was the treatment group difference (and 95% CI) in mean near control at the 8-week outcome visit using an ANCOVA adjusted for baseline near control.||0.7|-0.7|
73912639|NCT03338010|147355207|SUPERIORITY||LS Mean Difference|1.4||||0.732|TWO_SIDED|95.0|-6.7|9.5|||Mixed Models Analysis|||Bedtime Glucose||9.5|-6.7|0.732
73858588|NCT03571672|147263009|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.08|STANDARD_DEVIATION|5.98||0.868|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.868
73858589|NCT03571672|147263009|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.23|STANDARD_DEVIATION|5.445||0.606|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.606
73858590|NCT03571672|147263009|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.43|STANDARD_DEVIATION|4.212||0.224|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.224
73858591|NCT03571672|147263010|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|6.682||0.715|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.715
73858592|NCT03571672|147263010|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.526||0.956|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.956
73858593|NCT03571672|147263010|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.17|STANDARD_DEVIATION|4.584||0.771|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.771
73858594|NCT03571672|147263011|OTHER||Intra-class Correlation Coefficient|0.959|||||TWO_SIDED|95.0|0.944|0.97||||||Inter-Reader Variability Echo Enhanced||0.970|0.944|
73912640|NCT03338010|147355208|SUPERIORITY|||||||0.846|||||||Fisher Exact|||||||0.846
73912641|NCT03338010|147355209|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
73858595|NCT03571672|147263011|OTHER||Intra-class Correlation Coefficient|0.95|||||TWO_SIDED|95.0|0.931|0.964||||||Inter-Reader Variability Echo Unenhanced||0.964|0.931|
73858596|NCT03571672|147263011|OTHER||Intra-class Correlation Coefficient|0.957|||||TWO_SIDED|95.0|0.941|0.969||||||Inter-Reader Variability Echo Enhanced||0.969|0.941|
74026739|NCT01287117|147607063|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
74026740|NCT01287117|147607064|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.4580
74026741|NCT01287117|147607064|SUPERIORITY_OR_OTHER|||||||0.2087||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.2087
74026742|NCT01287117|147607064|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
74026743|NCT01676116|147607065|SUPERIORITY_OR_OTHER||Treatment contrast|-0.94|||<|0.001|TWO_SIDED|95.0|-1.11|-0.78|||ANCOVA|||||-0.78|-1.11|<0.001
74026744|NCT02680301|147607074|EQUIVALENCE|Wilcoxon sign- rank test values with ranks from change in cream efficacy ratings minus change in ointment efficacy ratings.||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
74026745|NCT02975349|147607120|SUPERIORITY||Lesion rate ratio|1.45||||0.2947|TWO_SIDED|95.0|0.72|2.91|||Negative Binomial model|||||2.91|0.72|0.2947
74026746|NCT02975349|147607120|SUPERIORITY||Lesion rate ratio|0.3||||0.0015|TWO_SIDED|95.0|0.14|0.63|||Negative Binomial model|||||0.63|0.14|0.0015
74026747|NCT02975349|147607120|SUPERIORITY||Lesion rate ratio|0.44||||0.0313|TWO_SIDED|95.0|0.21|0.93|||Negative Binomial model|||||0.93|0.21|0.0313
74026748|NCT02975349|147607121|SUPERIORITY||Qualified relapse rate ratio|1.66||||0.2692|TWO_SIDED|95.0|0.67|4.09|||Negative Binomial model|||||4.09|0.67|0.2692
74026749|NCT02975349|147607121|SUPERIORITY||Qualified relapse rate ratio|0.31||||0.0896|TWO_SIDED|95.0|0.08|1.2|||Negative Binomial model|||||1.20|0.08|0.0896
74026750|NCT02975349|147607121|SUPERIORITY||Qualified relapse rate ratio|0.23||||0.0633|TWO_SIDED|95.0|0.05|1.09|||Negative Binomial model|||||1.09|0.05|0.0633
74026751|NCT02975349|147607122|SUPERIORITY||Odds Ratio (OR)|0.75||||0.5609|TWO_SIDED|95.0|0.29|1.95|||Logistic model|||||1.95|0.29|0.5609
74026752|NCT02975349|147607122|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0689|TWO_SIDED|95.0|0.92|8.41|||Logistic model|||||8.41|0.92|0.0689
74026753|NCT02975349|147607122|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1767|TWO_SIDED|95.0|0.72|5.99|||Logistic model|||||5.99|0.72|0.1767
74026754|NCT02975349|147607123|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.407|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.4070
74026755|NCT02975349|147607123|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.5829|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.5829
73858597|NCT03571672|147263011|OTHER||Intra-class Correlation Coefficient|0.934|||||TWO_SIDED|95.0|0.909|0.952||||||Inter-Reader Variability Echo Unenhanced||0.952|0.909|
73858598|NCT03571672|147263011|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.946|0.972||||||Inter-Reader Variability Echo Enhanced||0.972|0.946|
73858599|NCT03571672|147263011|OTHER||Intra-class Correlation Coefficient|0.937|||||TWO_SIDED|95.0|0.913|0.954||||||Inter-Reader Variability Echo Unenhanced||0.954|0.913|
73858600|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.988|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-reader Variability End Diastolic Echo Enhanced||0.992|0.984|
73858601|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.986|||||TWO_SIDED|95.0|0.981|0.99||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.990|0.981|
73858602|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.96|||||TWO_SIDED|95.0|0.945|0.971||||||Inter-reader Variability End Diastolic Echo Enhanced||0.971|0.945|
73858603|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.925|||||TWO_SIDED|95.0|0.897|0.945||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.945|0.897|
74026756|NCT02975349|147607123|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.2732|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.2732
74026757|NCT02975349|147607135|SUPERIORITY||Lesion rate ratio|1.36||||0.3676|TWO_SIDED|95.0|0.7|2.65|||Negative Binomial|||||2.65|0.70|0.3676
74026758|NCT02975349|147607135|SUPERIORITY||Lesion rate ratio|0.27||||0.0005|TWO_SIDED|95.0|0.13|0.57|||Negative Binomial|||||0.57|0.13|0.0005
74026759|NCT02975349|147607135|SUPERIORITY||Lesion rate ratio|0.41||||0.0157|TWO_SIDED|95.0|0.2|0.85|||Negative Binomial|||||0.85|0.20|0.0157
74026760|NCT02975349|147607136|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9731|TWO_SIDED|95.0|-0.25|0.25|||Wilcoxon rank-sum test|||||0.25|-0.25|0.9731
74026761|NCT02975349|147607136|SUPERIORITY||Hodges-Lehmann estimate|-0.25||||0.0017|TWO_SIDED|95.0|-0.5|0.0|||Wilcoxon rank-sum test|||||0.00|-0.50|0.0017
74026762|NCT02975349|147607136|SUPERIORITY||Hodges-Lehmann estimate|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.25|||Wilcoxon rank-sum test|||||-0.25|-0.75|< 0.0001
74026763|NCT02975349|147607137|SUPERIORITY||Lesion Rate ratio|1.29||||0.4807|TWO_SIDED|95.0|0.63|2.65|||Negative Binomial|||||2.65|0.63|0.4807
73858604|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.97|||||TWO_SIDED|95.0|0.958|0.978||||||Inter-reader Variability End Diastolic Echo Enhanced||0.978|0.958|
73858605|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.909|||||TWO_SIDED|95.0|0.876|0.934||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.934|0.876|
73858606|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.989|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-reader Variability End Systolic Echo Enhanced||0.992|0.984|
73858607|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.985|||||TWO_SIDED|95.0|0.979|0.989||||||Inter-reader Variability End Systolic Echo Unenhanced||0.989|0.979|
73858608|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.962|0.98||||||Inter-reader Variability End Systolic Echo Enhanced||0.980|0.962|
73858609|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.947|||||TWO_SIDED|95.0|0.927|0.961||||||Inter-reader Variability End Systolic Echo Unenhanced||0.961|0.927|
73858610|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.969|0.984||||||Inter-reader Variability End Systolic Echo Enhanced||0.984|0.969|
73858611|NCT03571672|147263012|OTHER||Intra-class Correlation Coefficient|0.937|||||TWO_SIDED|95.0|0.914|0.954||||||Inter-reader Variability End Systolic Echo Unenhanced||0.954|0.914|
73858612|NCT03571672|147263013|OTHER||Intra-class Correlation Coefficient|0.945|||||TWO_SIDED|95.0|0.909|0.967||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.967|0.909|
73858613|NCT03571672|147263013|OTHER||Intra-class Correlation Coefficient|0.917|||||TWO_SIDED|95.0|0.864|0.95||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.950|0.864|
73858614|NCT03571672|147263013|OTHER||Intra-class Correlation Coefficient|0.939|||||TWO_SIDED|95.0|0.9|0.963||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.963|0.900|
73858615|NCT03571672|147263013|OTHER||Intra-class Correlation Coefficient|0.894|||||TWO_SIDED|95.0|0.827|0.935||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.935|0.827|
73858616|NCT03571672|147263013|OTHER||Intra-class Correlation Coefficient|0.952|||||TWO_SIDED|95.0|0.92|0.971||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.971|0.920|
74026764|NCT02975349|147607137|SUPERIORITY||Lesion Rate ratio|0.5||||0.062|TWO_SIDED|95.0|0.24|1.04|||Negative Binomial|||||1.04|0.24|0.0620
74026765|NCT02975349|147607137|SUPERIORITY||Lesion Rate ratio|0.42||||0.0189|TWO_SIDED|95.0|0.2|0.87|||Negative Binomial|||||0.87|0.20|0.0189
74026766|NCT02975349|147607138|SUPERIORITY||Difference in least squares means|0.02||||0.8776|TWO_SIDED|95.0|-0.24|0.28|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||0.28|-0.24|0.8776
73858617|NCT03571672|147263013|OTHER||Intra-class Correlation Coefficient|0.9|||||TWO_SIDED|95.0|0.838|0.939||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.939|0.838|
73858618|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.961|0.986||||||Inter-reader Variability End Diastolic Echo Enhanced||0.986|0.961|
73858619|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.974|0.991||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.991|0.974|
73858620|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.933|||||TWO_SIDED|95.0|0.89|0.96||||||Inter-reader Variability End Diastolic Echo Enhanced||0.960|0.890|
73858621|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.857|||||TWO_SIDED|95.0|0.77|0.912||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.912|0.770|
73858622|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.914|0.969||||||Inter-reader Variability End Diastolic Echo Enhanced||0.969|0.914|
73858623|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.824|||||TWO_SIDED|95.0|0.721|0.892||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.892|0.721|
73858624|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.982|||||TWO_SIDED|95.0|0.97|0.989||||||Inter-reader Variability End Systolic Echo Enhanced||0.989|0.970|
73858625|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.974|||||TWO_SIDED|95.0|0.957|0.985||||||Inter-reader Variability End Systolic Echo Unenhanced||0.985|0.957|
73858626|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.915|0.969||||||Inter-reader Variability End Systolic Echo Enhanced||0.969|0.915|
73858627|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.89|||||TWO_SIDED|95.0|0.822|0.933||||||Inter-reader Variability End Systolic Echo Unenhanced||0.933|0.822|
73858628|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.959|||||TWO_SIDED|95.0|0.932|0.975||||||Inter-reader Variability End Systolic Echo Enhanced||0.975|0.932|
73858629|NCT03571672|147263014|OTHER||Intra-class Correlation Coefficient|0.872|||||TWO_SIDED|95.0|0.794|0.922||||||Inter-reader Variability End Systolic Echo Unenhanced||0.922|0.794|
73858630|NCT00450294|147263018|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.||||<0.001
73858631|NCT00450294|147263019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.||||<0.001
73858632|NCT00798317|147263047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.13|||<|0.001|TWO_SIDED|95.0|1.97|17.0||Comparing placebo and ocriplasmin|Fisher Exact|||||17.00|1.97|<0.001
73858633|NCT04035564|147263120|SUPERIORITY||Risk Ratio (RR)|0.2||||0.71|TWO_SIDED|95.0|0.026|1.533|||Chi-squared|||||1.533|0.026|0.71
73858634|NCT04035564|147263121|SUPERIORITY||Risk Ratio (RR)|1.21||||0.89|TWO_SIDED|95.0|0.081|18.09|||Chi-squared|||||18.09|0.081|0.89
73858635|NCT04035564|147263122|SUPERIORITY||Mean Difference (Final Values)|-2.861|STANDARD_ERROR_OF_MEAN|1.286||0.032|TWO_SIDED|95.0|-5.461|-0.261|||t-test, 2 sided|||||-0.261|-5.461|0.032
73858636|NCT04035564|147263122|SUPERIORITY||Mean Difference (Final Values)|-2.86|STANDARD_ERROR_OF_MEAN|1.286||0.032|TWO_SIDED|95.0|-5.461|-0.261|||ANOVA|||||-0.261|-5.461|0.032
73858637|NCT04035564|147263123|SUPERIORITY||Mean Difference (Final Values)|-3.788|STANDARD_ERROR_OF_MEAN|2.299||0.107|TWO_SIDED|95.0|-8.43|0.858|||t-test, 2 sided|||||0.858|-8.43|0.107
74026767|NCT02975349|147607138|SUPERIORITY||Difference in least squares means|-0.41||||0.0019|TWO_SIDED|95.0|-0.66|-0.15|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||-0.15|-0.66|0.0019
74026768|NCT02975349|147607138|SUPERIORITY||Difference in least squares means|-0.36||||0.0063|TWO_SIDED|95.0|-0.62|-0.1|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||-0.10|-0.62|0.0063
74085543|NCT00401245|147725093|SUPERIORITY_OR_OTHER|||||||0.997||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.997
74085544|NCT00401245|147725093|SUPERIORITY_OR_OTHER|||||||0.009||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.009
74085545|NCT00401245|147725094|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.078
74085546|NCT00401245|147725094|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.005
73858638|NCT04035564|147263123|SUPERIORITY||Mean Difference (Final Values)|-3.78|STANDARD_ERROR_OF_MEAN|2.299||0.107|TWO_SIDED|95.0|-8.43|0.85|||ANOVA|||||0.85|-8.43|0.107
74085547|NCT00401245|147725094|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.929
74085548|NCT00401245|147725096|SUPERIORITY_OR_OTHER|||||||0.017||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).||||0.017
74085549|NCT00401245|147725103|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 4) value with 0.||||<0.001
73858639|NCT04035564|147263124|SUPERIORITY||Mean Difference (Final Values)|-39.38|STANDARD_ERROR_OF_MEAN|17.22||0.028|TWO_SIDED|95.0|-74.18|-4.57|||t-test, 2 sided|||||-4.57|-74.18|0.028
73858640|NCT04035564|147263124|SUPERIORITY||Mean Difference (Final Values)|-39.38|STANDARD_ERROR_OF_MEAN|17.22||0.028|TWO_SIDED|95.0|-74.18|-4.57|||ANOVA|||||-4.57|-74.18|0.028
73858641|NCT04035564|147263125|SUPERIORITY||Risk Ratio (RR)|0.75||||0.55|TWO_SIDED|95.0|0.296|1.932|||Chi-squared|||||1.932|0.296|0.55
73858642|NCT04035564|147263126|SUPERIORITY||Risk Ratio (RR)|1.09||||0.84|TWO_SIDED|95.0|0.169|7.096|||Chi-squared|||||7.096|0.169|0.84
73858643|NCT04035564|147263127|SUPERIORITY||Risk Ratio (RR)|0.8||||0.7|TWO_SIDED|95.0|0.266|2.448|||Chi-squared|||||2.448|0.266|0.70
73858644|NCT04035564|147263128|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
73858645|NCT04035564|147263128|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.57|TWO_SIDED||||||Regression, Cox|||||||0.57
74085550|NCT00401245|147725103|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 8) value with 0.||||< 0.001
74085551|NCT00401245|147725103|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the base value and post-baseline (Week 12) value with 0.||||<0.001
74085552|NCT00401245|147725103|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 16) value with 0.||||<0.001
73858646|NCT03344549|147263158|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|0.8||0.37|TWO_SIDED|95.0||||The threshoid for statistical significance was p \<0.05|t-test, 2 sided|||U Mann Whitney was used for inter-group comparison||||0.37
73858647|NCT03344549|147263159|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|0.8||0.46|TWO_SIDED|95.0||||The threshold for statistical significance was p\<0.05|t-test, 2 sided|U Mann Whitney was used for inter-group comparison||||||0.46
73858648|NCT03344549|147263160|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
73858649|NCT00108303|147263167|SUPERIORITY_OR_OTHER||Log (odd ratio)|5.2|||||TWO_SIDED|||||||||||||
73858650|NCT00108303|147263167|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||This parameter was estimated by simulating 1000 samples with random genotypes and finding no value equal to or greater than 5.2.|Simulation|||||||<0.001
73858651|NCT00108303|147263168|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Firsher's transform r to Z|||The coefficient of segregation versus no segregation of the P50 sensory gating percent in families with schizophrenia.||||0.001
73858652|NCT01007123|147263179|SUPERIORITY_OR_OTHER||||||<|0.2|TWO_SIDED|0.0|||||ANCOVA|||||||<0.2
73858653|NCT01007123|147263179|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|0.0|||||ANCOVA|||||||0.002
73858654|NCT01007123|147263179|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
73858655|NCT01007123|147263180|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|0.0|||||Fisher Exact|||||||0.03
73858656|NCT01007123|147263180|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|0.0|||||Fisher Exact|||||||0.008
73858657|NCT01007123|147263180|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||Fisher Exact|||||||<0.001
73858658|NCT01007123|147263181|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED|0.0|||||Fisher Exact|||||||0.06
73858659|NCT01007123|147263181|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|0.0|||||Fisher Exact|||||||0.03
73912642|NCT03338010|147355210|SUPERIORITY||LS Mean Difference|0.32||||0.767|TWO_SIDED|95.0|-1.78|2.42|||Mixed Models Analysis|||Morning Pre-meal Standard Deviation||2.42|-1.78|0.767
73912643|NCT03338010|147355210|SUPERIORITY||LS Mean Difference|0.4||||0.781|TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||Daily Mean Standard Deviation||3.3|-2.5|0.781
73965238|NCT02590432|147465513|SUPERIORITY||Hazard Ratio (HR)|0.27||||0.0234|TWO_SIDED|95.0|0.08|0.87|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg||0.87|0.08|0.0234
73965239|NCT02590432|147465513|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.4518|TWO_SIDED|95.0|0.39|1.47|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg||1.47|0.39|0.4518
73965240|NCT04788641|147465567|OTHER||Geometric LS Mean Ratio (%)|71.1|||||TWO_SIDED|90.0|65.44|77.24|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||77.24|65.44|
73965241|NCT04788641|147465567|OTHER||Geometric LS Mean Ratio (%)|102.9|||||TWO_SIDED|90.0|96.11|110.1|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||110.1|96.11|
74085553|NCT01989676|147725106|EQUIVALENCE|The hypothesis to be tested in this study was that the risk ratio of ORR of PF-05280014 versus that of trastuzumab-EU by Week 25 (+/-14 days) was within a pre-specified margin of 0.80 to 1.25.|Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.842|1.049||||||Risk Ratio and associated 95% confidence interval (CI) are unstratified and based on the Miettinen and Nurminen method.||1.049|0.842|
73858660|NCT01007123|147263181|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|0.0|||||Fisher Exact|||||||0.04
73858661|NCT01007123|147263182|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|0.0|||||ANCOVA|||||||0.44
73858662|NCT01007123|147263182|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
73858663|NCT01007123|147263182|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
73858664|NCT01007123|147263183|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|0.0|||||ANCOVA|||Comparison vs placebo||||0.01
73858665|NCT01007123|147263183|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|0.0|||||ANCOVA|||Comparison vs placebo||||<0.05
73858666|NCT01007123|147263184|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|0.0|||||ANCOVA|||||||0.17
73858667|NCT01007123|147263184|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
73858668|NCT01007123|147263184|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
73858669|NCT02075047|147263185|SUPERIORITY||Difference in least square (LS) mean|-4.23|STANDARD_ERROR_OF_MEAN|1.47||0.005|TWO_SIDED|95.0|-7.14|-1.32|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-1.32|-7.14|0.005
73912644|NCT03338010|147355211|SUPERIORITY||LS Mean Difference|0.2||||0.75|TWO_SIDED|95.0|-1.2|1.7|||Mixed Models Analysis|||||1.7|-1.2|0.750
73912645|NCT03338010|147355212|SUPERIORITY||LS Mean Difference|0.2||||0.75|TWO_SIDED|95.0|-1.2|1.7|||Mixed Models Analysis|||||1.7|-1.2|0.750
73912646|NCT03338010|147355213|SUPERIORITY||LS Mean Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-0.6|0.3|||Mixed Models Analysis|||||0.3|-0.6|<0.001
73912647|NCT03338010|147355214|SUPERIORITY||LS Mean Difference|-0.95||||0.5|TWO_SIDED|95.0|-3.72|1.82|||Mixed Models Analysis|||Inconvenience of Regimen Transformed Score||1.82|-3.72|0.500
73912648|NCT03338010|147355214|SUPERIORITY||LS Mean Difference|-3.99||||0.031|TWO_SIDED|95.0|-7.62|-0.36|||Mixed Models Analysis|||Lifestyle Flexibility Transformed Score||-0.36|-7.62|0.031
73912649|NCT03338010|147355214|SUPERIORITY||LS Mean Difference|-1.79||||0.2|TWO_SIDED|95.0|-4.53|0.95|||Mixed Models Analysis|||Hypoglycemic Control Transformed Score||0.95|-4.53|0.200
73912650|NCT03338010|147355214|SUPERIORITY||LS Mean Difference|-0.02||||0.988|TWO_SIDED|95.0|-2.92|2.88|||Mixed Models Analysis|||Glycemic Control Transformed Score||2.88|-2.92|0.988
73912651|NCT03338010|147355214|SUPERIORITY||LS Mean Difference|-1.45||||0.337|TWO_SIDED|95.0|-4.41|1.51|||Mixed Models Analysis|||Insulin Delivery Device Satisfaction Transformed Score||1.51|-4.41|0.337
73965242|NCT04788641|147465568|OTHER||Geometric LS Mean Ratio (%)|62.91|||||TWO_SIDED|90.0|55.64|71.13|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||71.13|55.64|
73965243|NCT04788641|147465568|OTHER||Geometric LS Mean Ratio (%)|97.23|||||TWO_SIDED|90.0|92.93|101.7|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||101.7|92.93|
73965244|NCT04788641|147465569|OTHER||Geometric LS Mean Ratio (%)|65.57|||||TWO_SIDED|90.0|58.69|73.24|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||73.24|58.69|
73965245|NCT04788641|147465569|OTHER||Geometric LS Mean Ratio (%)|97.04|||||TWO_SIDED|90.0|92.7|101.6|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||101.6|92.70|
73965246|NCT04788641|147465570|OTHER||Geometric LS Mean Ratio (%)|83.86|||||TWO_SIDED|90.0|73.38|95.84|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||95.84|73.38|
73965247|NCT04788641|147465570|OTHER||Geometric LS Mean Ratio (%)|97.55|||||TWO_SIDED|90.0|87.16|109.2|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||109.2|87.16|
74085554|NCT01989676|147725107|SUPERIORITY||Cox Proportional Hazard|1.0||||0.505|TWO_SIDED|95.0|0.8|1.26||1-sided log-rank test was used to compare the PFS distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and estrogen receptor (ER) status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.26|0.80|0.505
74085555|NCT01989676|147725108|SUPERIORITY||Cox Proportional Hazard|0.92||||0.304|TWO_SIDED|95.0|0.67|1.27||1-sided log-rank test was used to compare the DOR distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and ER status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.27|0.67|0.304
74085556|NCT01989676|147725109|SUPERIORITY||Cox Proportional Hazard|0.929||||0.339|TWO_SIDED|95.0|0.656|1.316||1-sided log-rank test was used to compare the OS distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and ER status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.316|0.656|0.339
74085557|NCT03941834|147725116|OTHER||Least square (LS) mean difference|0.7|||||TWO_SIDED|95.0|0.1|1.2||||||Analysis were performed using a mixed model with fixed effects for treatment, period and sequence; baseline NPRS as a covariate; and participant as a random effect.||1.2|0.1|
74085558|NCT03941834|147725121|OTHER||LS mean difference|2.4|||||TWO_SIDED|95.0|-6.8|11.5||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline Penn-FPS-R as a covariate; and participant as a random effect.||11.5|-6.8|
74085559|NCT03941834|147725122|OTHER||LS Mean Difference|1.5|||||TWO_SIDED|95.0|-3.8|6.9||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline pain disability index as a covariate; and participant as a random effect.||6.9|-3.8|
74085560|NCT03941834|147725123|OTHER||LS Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.7|0.5||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; and participant as a random effect.||0.5|-0.7|
73858670|NCT02075047|147263186|SUPERIORITY||Difference in LS mean|-0.45|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.69|-0.2|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-0.20|-0.69|<0.001
73912652|NCT03338010|147355214|SUPERIORITY||LS Mean Difference|-1.67||||0.205|TWO_SIDED|95.0|-4.26|0.92|||Mixed Models Analysis|||ITSQ Overall Total||0.92|-4.26|0.205
74085561|NCT03941834|147725124|OTHER||LS Mean Difference|0.7|||||TWO_SIDED|95.0|0.1|1.4||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline NPRS as a covariate; and participant as a random effect.||1.4|0.1|
74085562|NCT03941834|147725125|OTHER||Odds Ratio (OR)|12.6|||||TWO_SIDED|95.0|0.7|229.6||||||Analysis was performed using a logistic regression model, including fixed effects for treatment, sequence, period and baseline NPRS score as a covariate.||229.6|0.7|
74085563|NCT00991510|147725129|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.923|||||TWO_SIDED|90.0|0.865|0.984|||ANOVA|||A total of 100 subjects were planned to be enrolled, allowing for 10% drop-out rate. Based on previous single dose studies, the intra-subject coefficients of variation were 14% and 50% for AUC and Cmax, respectively. Based on the literature similar intra subject coefficients of variation were observed in steady-state patients. With these expected CV(%) and an expected ratio of Cmax within 0.95 and 1.05, the study should have a power of at least 80 % to show bioequivalence with 80 subjects.||0.984|0.865|
74085564|NCT00991510|147725130|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.959|||||TWO_SIDED|90.0|0.899|1.023|||ANOVA|||||1.023|0.899|
74085565|NCT00991510|147725131|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.873|||||TWO_SIDED|90.0|0.787|0.968|||ANOVA|||||0.968|0.787|
74085566|NCT00991510|147725132|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.985|||||TWO_SIDED|90.0|0.877|1.106|||ANOVA|||||1.106|0.877|
74085567|NCT03404401|147725191|NON_INFERIORITY|Non-inferiority margin was set at 10%.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74085568|NCT00988208|147725196|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.0017|TWO_SIDED|95.0|1.17|2.0||p-value is based on unstratified log-rank test|Log Rank|||||2.00|1.17|0.0017
74085569|NCT00988208|147725197|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.0187|TWO_SIDED|95.0|1.05|1.66|||Log Rank|P-value is based on unstratified log-rank test||||1.66|1.05|0.0187
74085570|NCT00988208|147725198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.884||||0.3975|TWO_SIDED|95.0|0.665|1.176|||Chi-squared|||||1.176|0.665|0.3975
74085571|NCT01315028|147725208|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
74085572|NCT01315028|147725209|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANOVA|||Parametric and non-parametric descriptive data were summarised and presented. All data analyses were based on the Intention to Treat (ITT) principle. For the main analysis, Repeated Measures Analysis of Variance was performed to identify signals suggesting treatment effects on the outcome measures. Effect sizes were also calculated in order to further examine suggestive trends in the data indicating appropriate outcomes for further research.||||0.996
74085573|NCT01315028|147725210|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
74085574|NCT01315028|147725211|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
74085575|NCT01077817|147725212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.7|1.5|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to alendronate treatment and incidence of esophageal cancer.||1.5|0.7|
74085576|NCT01077817|147725212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to etidronate treatment and incidence of esophageal cancer.||2.0|0.9|
74085577|NCT01077817|147725212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|4.9|||||TWO_SIDED|95.0|1.4|16.7|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to ibandronate treatment and incidence of esophageal cancer.||16.7|1.4|
74085578|NCT01077817|147725212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|1.0|2.5|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to risedronate treatment and incidence of esophageal cancer.||2.5|1.0|
74085579|NCT01077817|147725212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.2|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to raloxifene treatment and incidence of esophageal cancer.||2.2|0.2|
73858671|NCT02075047|147263186|SUPERIORITY||Difference in LS mean|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.174|TWO_SIDED|95.0|-0.53|0.1|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.10|-0.53|0.174
73858672|NCT02075047|147263186|SUPERIORITY||Difference in LS mean|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.024|TWO_SIDED|95.0|-0.71|-0.05|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-0.05|-0.71|0.024
73858673|NCT02075047|147263186|SUPERIORITY||Difference in LS mean|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.138|TWO_SIDED|95.0|-0.64|0.09|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.09|-0.64|0.138
73858674|NCT02075047|147263187|SUPERIORITY||Difference in LS mean|-5.85|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|TWO_SIDED|95.0|-8.16|-3.54|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-3.54|-8.16|<0.001
73912653|NCT03338010|147355215|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.639
73912654|NCT03338010|147355216|SUPERIORITY||Relative Ratio|1.19||||0.143|TWO_SIDED|95.0|0.74|1.92|||Wilcoxon (Mann-Whitney)|||||1.92|0.74|0.143
74026769|NCT02975349|147607139|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9315|TWO_SIDED|95.0|-0.004|0.009|||Wilcoxon rank-sum test|||||0.009|-0.004|0.9315
73912655|NCT03338010|147355216|SUPERIORITY||Relative Ratio|1.22||||0.945|TWO_SIDED|95.0|0.67|2.23|||Wilcoxon (Mann-Whitney)|||||2.23|0.67|0.945
73912656|NCT01211730|147355217|SUPERIORITY_OR_OTHER|||||||0.709|||||||Chi-squared, Corrected|||||||0.709
73912657|NCT01211730|147355218|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared, Corrected|||||||0.003
73912658|NCT01211730|147355219|SUPERIORITY_OR_OTHER|||||||0.0046|||||||Chi-squared, Corrected|||||||0.0046
73912659|NCT01211730|147355220|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared, Corrected|||||||0.75
73912660|NCT01211730|147355221|SUPERIORITY_OR_OTHER|||||||0.56|||||||Chi-squared, Corrected|||||||0.56
73912661|NCT01211730|147355222|SUPERIORITY_OR_OTHER|||||||0.77|||||||Chi-squared, Corrected|||||||0.77
73912662|NCT00293033|147355237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.74|STANDARD_ERROR_OF_MEAN|3.28||0.004|TWO_SIDED|95.0|3.31|16.18|||Mixed Models Analysis|The SPID was analyzed using a mixed model of repeated measures with fixed effects for treatment, pooled site, and a random effect for subjects.|Onsolis minus placebo|||16.18|3.31|0.004
73912663|NCT00293033|147355238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.33||0.44|TWO_SIDED|95.0|-0.4|0.91|||Wilcoxon (Mann-Whitney)|||||0.91|-0.40|0.440
73912664|NCT00293033|147355239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.7||0.179|TWO_SIDED|95.0|-0.44|2.33|||Mixed Models Analysis|||||2.33|-0.44|0.179
73912665|NCT00293033|147355240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|1.16||0.047|TWO_SIDED|95.0|0.04|4.61|||Mixed Models Analysis|||||4.61|0.04|0.047
74026770|NCT02975349|147607139|SUPERIORITY||Hodges-Lehmann estimate|-0.014||||0.0008|TWO_SIDED|95.0|-0.05|0.0|||Wilcoxon rank-sum test|||||0.000|-0.050|0.0008
74026771|NCT02975349|147607139|SUPERIORITY||Hodges-Lehmann estimate|-0.018||||0.0014|TWO_SIDED|95.0|-0.042|0.0|||Wilcoxon rank-sum test|||||0.000|-0.042|0.0014
74026772|NCT01225068|147607174|SUPERIORITY_OR_OTHER||effect size|0.22||||||||||no p value for effect size calculations ES is dimensionless; ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (here at baseline and 6 weeks) divided by the pooled standard deviation.|effect size is endpoint and not comparis|no p value for effect size calculations||effect size is endpoint and not comparison||||
74029778|NCT03151148|147614041|SUPERIORITY||Geometric mean ratio (GMR)|0.465||||0.675|TWO_SIDED|95.0|0.0128|16.8576|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||16.8576|0.0128|0.675
73858675|NCT02075047|147263187|SUPERIORITY||Difference in LS mean|-4.17|STANDARD_ERROR_OF_MEAN|1.3||0.002|TWO_SIDED|95.0|-6.74|-1.59|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-1.59|-6.74|0.002
73858676|NCT02075047|147263187|SUPERIORITY||Difference in LS mean|-5.63|STANDARD_ERROR_OF_MEAN|1.31|<|0.001|TWO_SIDED|95.0|-8.21|-3.04|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-3.04|-8.21|<0.001
73858677|NCT02075047|147263188|SUPERIORITY||Difference in LS mean|-0.52|STANDARD_ERROR_OF_MEAN|0.13||0.001|TWO_SIDED|95.0|-0.78|-0.26|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||-0.26|-0.78|0.001
73858678|NCT02075047|147263188|SUPERIORITY||Difference in LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.349|TWO_SIDED|95.0|-0.45|0.16|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||0.16|-0.45|0.349
73858679|NCT02075047|147263188|SUPERIORITY||Difference in LS mean|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.103|TWO_SIDED|95.0|-0.57|0.05|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||0.05|-0.57|0.103
73858680|NCT02075047|147263188|SUPERIORITY||Difference in LS mean|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.044|TWO_SIDED|95.0|-0.68|-0.01|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||-0.01|-0.68|0.044
73912666|NCT00293033|147355241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.68|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|8.5|30.86|||Mixed Models Analysis|||||30.86|8.50|<0.001
74026773|NCT04426630|147607252|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.||||<0.001
74026774|NCT04426630|147607253|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
74026775|NCT04426630|147607254|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
74026776|NCT04426630|147607255|SUPERIORITY|||||||0.028|||||||Chi-squared|Wilcoxon sign-rank test used to compared baseline outcomes to 6 month outcomes.||Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.||||0.028
74026777|NCT04426630|147607256|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74026778|NCT04426630|147607257|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73858681|NCT02075047|147263202|SUPERIORITY||Difference in LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.05||0.05|TWO_SIDED|95.0|0.0|0.2|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.20|0.00|0.050
73858682|NCT02075047|147263202|SUPERIORITY||Difference in LS mean|0.11|STANDARD_ERROR_OF_MEAN|0.07||0.124|TWO_SIDED|95.0|-0.03|0.25|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.25|-0.03|0.124
73858683|NCT02075047|147263202|SUPERIORITY||Difference in LS mean|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.23|-0.01|0.084
73858684|NCT02075047|147263202|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.05||0.104|TWO_SIDED|95.0|-0.02|0.2|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.20|-0.02|0.104
73912667|NCT00293033|147355242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|31.98|STANDARD_ERROR_OF_MEAN|8.23|<|0.001|TWO_SIDED|95.0|15.85|48.12|||Mixed Models Analysis|||||48.12|15.85|<0.001
73912668|NCT00293033|147355243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.517|||||||Wilcoxon (Mann-Whitney)|||||||0.517
73912669|NCT00293033|147355244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||||||0.458
73912670|NCT00293033|147355245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||||||0.223
74026779|NCT04426630|147607258|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
74026780|NCT04426630|147607259|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74026781|NCT04426630|147607260|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
74026782|NCT04426630|147607261|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
74026783|NCT04426630|147607262|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.07
74026784|NCT04426630|147607263|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74026785|NCT02396147|147607264|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|87.09|||||TWO_SIDED|90.0|58.56|129.52|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference)\*100|||129.52|58.56|
73912671|NCT00293033|147355246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
73912672|NCT00293033|147355247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73912673|NCT00293033|147355248|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73912674|NCT00293033|147355249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|||||||Wilcoxon (Mann-Whitney)|||||||0.193
73912675|NCT00293033|147355250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||||||0.113
73912676|NCT00293033|147355251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||Wilcoxon (Mann-Whitney)|||||||0.192
73912677|NCT00293033|147355252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73965248|NCT04788641|147465571|OTHER||Geometric LS Mean Ratio (%)|98.42|||||TWO_SIDED|90.0|94.62|102.4|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||102.4|94.62|
73965249|NCT04788641|147465571|OTHER||Geometric LS Mean Ratio (%)|94.12|||||TWO_SIDED|90.0|85.74|103.3|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||103.3|85.74|
73965250|NCT02740231|147465579|SUPERIORITY||Adjusted mean difference|-9.49|STANDARD_DEVIATION|6.38||0.141|TWO_SIDED|95.0|-22.21|3.23||The threshold for statistical significance was p=0.05|ANCOVA||Difference between groups JTA-004 100 (2mL) minus Reference - adjusted mean change|The primary endpoint is the WOMAC® VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group.||3.23|-22.21|0.141
73912678|NCT00293033|147355253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73912679|NCT00293033|147355254|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73912680|NCT00293033|147355255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
73912681|NCT00293033|147355256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||||||0.278
73912682|NCT00293033|147355257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||||||0.062
73912683|NCT00293033|147355258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73912684|NCT00293033|147355259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73912685|NCT00293033|147355260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73912686|NCT00293033|147355261|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73912687|NCT00293033|147355262|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
73912688|NCT00293033|147355263|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
73912689|NCT00293033|147355264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563|||||||Wilcoxon (Mann-Whitney)|||||||0.563
73912690|NCT00293033|147355265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.498|||||||Wilcoxon (Mann-Whitney)|||||||0.498
73912691|NCT00293033|147355266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
73912692|NCT00293033|147355267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
73912693|NCT00293033|147355268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.963|||||||Wilcoxon (Mann-Whitney)|||||||0.963
73912694|NCT00293033|147355269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73912695|NCT00293033|147355270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
73912696|NCT00293033|147355271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73912697|NCT00293033|147355272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
73912698|NCT00293033|147355273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
73912699|NCT00293033|147355274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73912700|NCT00293033|147355275|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73912701|NCT00293033|147355276|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
73912702|NCT00293033|147355277|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
73912703|NCT00293033|147355278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.750
73912704|NCT00293033|147355279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
73912705|NCT00293033|147355280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
73912706|NCT00293033|147355281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
73912707|NCT00293033|147355282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73912708|NCT00293033|147355283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|2.57||0.023|TWO_SIDED|95.0|0.92|11.01|||Mixed Models Analysis|||||11.01|0.92|0.023
73912709|NCT00293033|147355284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.84|STANDARD_ERROR_OF_MEAN|7.25||0.009|TWO_SIDED|95.0|5.63|34.04|||Mixed Models Analysis|||||34.04|5.63|0.009
73912710|NCT00293033|147355285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.26|STANDARD_ERROR_OF_MEAN|12.72||0.012|TWO_SIDED|95.0|8.32|58.2|||Mixed Models Analysis|||||58.20|8.32|0.012
73912711|NCT00293033|147355286|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|46.88|STANDARD_ERROR_OF_MEAN|18.46||0.015|TWO_SIDED|95.0|10.69|83.08|||Mixed Models Analysis|||||83.08|10.69|0.015
73965251|NCT02740231|147465580|SUPERIORITY||Adjusted mean difference|-11.63|STANDARD_DEVIATION|5.5||0.038|TWO_SIDED|95.0|-22.6|-0.66||The threshold for statistical significance was p=0.05|ANCOVA||Difference between groups JTA-004 100 (2mL) minus Reference|||-0.66|-22.60|0.038
73965252|NCT02740231|147465581|SUPERIORITY||Adjusted mean difference|-1.48|STANDARD_DEVIATION|4.35||0.997|TWO_SIDED|95.0|-12.7|9.74||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||9.74|-12.70|0.997
73965253|NCT02740231|147465582|SUPERIORITY||Adjusted mean difference|-2.94|STANDARD_DEVIATION|5.3||0.972|TWO_SIDED|95.0|-16.52|10.65||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||10.65|-16.52|0.972
73965254|NCT02740231|147465583|SUPERIORITY||Adjusted mean difference|-7.17|STANDARD_DEVIATION|5.96||0.599|TWO_SIDED|95.0|-22.28|7.94||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||7.94|-22.28|0.599
73965255|NCT02740231|147465584|SUPERIORITY||Adjusted mean difference|-6.62|STANDARD_DEVIATION|4.3||0.126|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.126
73965256|NCT02740231|147465585|SUPERIORITY||Adjusted mean difference|-8.88|STANDARD_DEVIATION|4.76||0.064|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.064
73965257|NCT02740231|147465586|SUPERIORITY||Adjusted mean difference|-10.79|STANDARD_DEVIATION|4.35||0.014|TWO_SIDED|95.0|||||ANCOVA|||||||0.014
73858685|NCT02075047|147263203|SUPERIORITY||Difference in LS mean|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.169|TWO_SIDED|95.0|-0.06|0.01|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.01|-0.06|0.169
73858686|NCT02075047|147263203|SUPERIORITY||Difference in LS mean|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.893|TWO_SIDED|95.0|-0.1|0.08|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.08|-0.10|0.893
73858687|NCT02075047|147263203|SUPERIORITY||Difference in LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.915|TWO_SIDED|95.0|-0.04|0.04|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.04|-0.04|0.915
73858688|NCT02075047|147263203|SUPERIORITY||Difference in LS mean|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.289|TWO_SIDED|95.0|-0.01|0.04|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.04|-0.01|0.289
73858689|NCT02075047|147263204|SUPERIORITY||Difference in LS mean|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.145|TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.06|-0.01|0.145
73858690|NCT02075047|147263204|SUPERIORITY||Difference in LS mean|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.148|TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.07|-0.01|0.148
73858691|NCT02075047|147263204|SUPERIORITY||Difference in LS mean|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.082|TWO_SIDED|95.0|-0.01|0.15|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.15|-0.01|0.082
73858692|NCT02075047|147263204|SUPERIORITY||Difference in LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.07|TWO_SIDED|95.0|0.0|0.09|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.09|-0.00|0.070
73858693|NCT00297102|147263207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|39.0|STANDARD_ERROR_OF_MEAN|11.0||0.0003|TWO_SIDED|95.0|18.0|60.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||60|18|0.0003
73858694|NCT00297102|147263208|SUPERIORITY_OR_OTHER||Rate ratio|0.851|STANDARD_ERROR_OF_MEAN|0.062||0.0278|TWO_SIDED|95.0|0.737|0.982||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||0.982|0.737|0.0278
73858695|NCT00297102|147263209|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|26.0|71.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||71|26|<0.0001
73912712|NCT00365508|147355290|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||a priori threshold for statistical significance|Chi-squared|||Chi-square was used to examine the relationship between treatment arm and 24-hour point prevalence abstinence at 6-months.||||.05
73912713|NCT05248867|147355295|SUPERIORITY||Rate Difference|59.3|||<|0.0001|TWO_SIDED|95.0|54.7|63.9||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||63.9|54.7|<0.0001
73912714|NCT05248867|147355296|SUPERIORITY||Rate Difference|60.2|||<|0.0001|TWO_SIDED|95.0|54.9|65.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||65.4|54.9|<0.0001
73912715|NCT05248867|147355297|SUPERIORITY||Rate Difference|71.4|||<|0.0001|TWO_SIDED|95.0|66.5|76.2||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||76.2|66.5|<0.0001
73965258|NCT02740231|147465587|SUPERIORITY||Adjusted mean difference|-10.57|STANDARD_DEVIATION|4.81||0.03|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.030
74026786|NCT02396147|147607264|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|83.09|||||TWO_SIDED|90.0|59.95|115.18|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||115.18|59.95|
73858696|NCT00297102|147263210|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035|STANDARD_ERROR_OF_MEAN|0.357||0.9212|TWO_SIDED|95.0|0.526|2.034||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 765 in the roflumilast group, n= 758 in the placebo group).|||2.034|0.526|0.9212
73858697|NCT00297102|147263211|SUPERIORITY_OR_OTHER||Mean Difference calculated as ratio|0.9521||||0.4089|TWO_SIDED|95.0|0.8472|1.0699||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method||||1.0699|0.8472|0.4089
73858698|NCT00297102|147263212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.111||0.0356|TWO_SIDED|95.0|0.016|0.449||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||0.449|0.016|0.0356
73858699|NCT01774097|147263223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.238|TWO_SIDED|95.0|-0.6|2.5||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||2.5|-0.6|0.238
73858700|NCT01774097|147263224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.6||0.116|TWO_SIDED|95.0|-0.2|2.1||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||2.1|-0.2|0.116
73858701|NCT01774097|147263225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.978|TWO_SIDED|95.0|-0.8|0.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||0.8|-0.8|0.978
73858702|NCT01774097|147263226|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.55||0.752|TWO_SIDED|95.0|-1.26|0.91||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||0.91|-1.26|0.752
73858703|NCT01774097|147263227|SUPERIORITY_OR_OTHER||interaction term|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.871|TWO_SIDED|95.0|-0.02|0.03||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||0.03|-0.02|0.871
73858704|NCT01774097|147263228|SUPERIORITY_OR_OTHER||interaction term|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.256|TWO_SIDED|95.0|-0.06|0.02||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||0.02|-0.06|0.256
73858705|NCT01774097|147263229|SUPERIORITY_OR_OTHER||interaction term|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.241|TWO_SIDED|95.0|-0.2|0.6|||Regression, Linear|||||0.6|-0.2|0.241
73858706|NCT01774097|147263231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.4||0.131|TWO_SIDED|95.0|-0.6|4.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.8|-0.6|0.131
73858707|NCT01774097|147263232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.7||0.626|TWO_SIDED|95.0|-2.6|4.2||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.2|-2.6|0.626
73858708|NCT01774097|147263233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.6||0.591|TWO_SIDED|95.0|-4.1|2.3||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||2.3|-4.1|0.591
73858709|NCT01774097|147263234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|2.0||0.722|TWO_SIDED|95.0|-3.3|4.7||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.7|-3.3|0.722
73858710|NCT03061721|147263243|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
73858711|NCT03061721|147263243|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
73858712|NCT03061721|147263243|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73858713|NCT03061721|147263244|SUPERIORITY|||||||0.5681|||||||ANCOVA|||||||0.5681
73858714|NCT03061721|147263244|SUPERIORITY|||||||0.4487|||||||ANCOVA|||||||0.4487
73858715|NCT03061721|147263244|SUPERIORITY|||||||0.0021|||||||ANCOVA|||||||0.0021
73858716|NCT03061721|147263245|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.0070
73858717|NCT03061721|147263245|SUPERIORITY|||||||0.0031|||||||Chi-squared|||||||0.0031
73858718|NCT03061721|147263245|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
73858719|NCT03061721|147263246|SUPERIORITY|||||||0.2241|||||||ANCOVA|||||||0.2241
73858720|NCT03061721|147263246|SUPERIORITY|||||||0.0304|||||||ANCOVA|||||||0.0304
73858721|NCT03061721|147263246|SUPERIORITY|||||||0.0595|||||||ANCOVA|||||||0.0595
73858722|NCT03061721|147263247|SUPERIORITY|||||||0.0449|||||||ANCOVA|||||||0.0449
73858723|NCT03061721|147263247|SUPERIORITY|||||||0.0053|||||||ANCOVA|||||||0.0053
73858724|NCT03061721|147263247|SUPERIORITY|||||||0.0036|||||||ANCOVA|||||||0.0036
73858725|NCT03061721|147263248|SUPERIORITY|||||||0.0045|||||||ANCOVA|||||||0.0045
73858726|NCT03061721|147263248|SUPERIORITY|||||||0.0026|||||||ANCOVA|||||||0.0026
73858727|NCT03061721|147263248|SUPERIORITY|||||||0.0004|||||||ANCOVA|||||||0.0004
73858728|NCT03061721|147263257|SUPERIORITY|||||||0.2387|||||||ANCOVA|||||||0.2387
73858729|NCT03061721|147263257|SUPERIORITY|||||||0.1496|||||||ANCOVA|||||||0.1496
73858730|NCT03061721|147263257|SUPERIORITY|||||||0.0445|||||||ANCOVA|||||||0.0445
73858731|NCT01920568|147263259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||<|0.0001|TWO_SIDED|95.0|-0.44|-0.192|||ANCOVA||Primary analysis evaluated the log transformed chg from BL, i.e. log\[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)\] by ANCOVA model with trt group as main effect and the stratification factor (breast cancer, yes or no) and log transformed BL value as covariates.|||-0.192|-0.440|<0.0001
73858732|NCT01920568|147263260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||<|0.0001|TWO_SIDED|95.0|-0.444|-0.188|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, ie log\[(Wk 13 uNTx/Cr)/(BL uNTx/Cr)\] by ANCOVA model with trt group as main effect and the stratification factor (Chinese participants, yes or no) and log transformed BL value|||-0.188|-0.444|<0.0001
73858733|NCT01920568|147263261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.366|||<|0.0001|TWO_SIDED|95.0|-0.539|-0.193|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, i.e. log\[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)\] by ANCOVA model with trt group as main effect, stratification factor (Breast cancer, yes or no) and log transformed BL value as covariates.|||-0.193|-0.539|<0.0001
73858734|NCT00252694|147263271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1994|TWO_SIDED|95.0|0.704|1.076|||Log Rank|Generalized||||1.076|0.704|0.1994
73912716|NCT05248867|147355302|SUPERIORITY||Rate Difference|72.5|||<|0.0001|TWO_SIDED|95.0|67.4|77.6||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||77.6|67.4|<0.0001
73912717|NCT05248867|147355303|SUPERIORITY||Rate Difference|41.9|||<|0.0001|TWO_SIDED|95.0|34.5|49.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||49.3|34.5|<0.0001
73912718|NCT05248867|147355304|SUPERIORITY||Rate Difference|69.5|||<|0.0001|TWO_SIDED|95.0|63.7|75.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||75.3|63.7|<0.0001
73912719|NCT05248867|147355305|SUPERIORITY||Rate Difference|58.2|||<|0.0001|TWO_SIDED|95.0|51.3|65.0||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||65.0|51.3|<0.0001
73912720|NCT05248867|147355306|SUPERIORITY||Rate Difference|30.1|||<|0.0001|TWO_SIDED|95.0|25.2|35.1||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||35.1|25.2|<0.0001
73912721|NCT05248867|147355307|SUPERIORITY||Rate Difference|35.7|||<|0.0001|TWO_SIDED|95.0|30.5|40.9||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||40.9|30.5|<0.0001
73965259|NCT01000480|147465628|SUPERIORITY_OR_OTHER|||||||0.0645||95.0||||P-value for H0 which compared the investigational regimen to historical data.|maximum likelihood estimate|||Null hypothesis (H0): 1-year PFS ≤45% and the alternative hypothesis (H1): 1-year PFS ≥60%, at a 2-sided alpha level of 5%, assuming that PFS time followed an exponential distribution.||||0.0645
73912722|NCT05248867|147355308|SUPERIORITY||Rate Difference|52.6|||<|0.0001|TWO_SIDED|95.0|45.2|60.0||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||60.0|45.2|<0.0001
73912723|NCT05248867|147355309|SUPERIORITY||Rate Difference|58.6|||<|0.0001|TWO_SIDED|95.0|51.1|66.1||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||66.1|51.1|<0.0001
73912724|NCT05248867|147355310|SUPERIORITY||Rate Difference|42.5|||<|0.0001|TWO_SIDED|95.0|34.4|50.6||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||50.6|34.4|<0.0001
73912725|NCT05248867|147355311|SUPERIORITY||Rate Difference|70.0|||<|0.0001|TWO_SIDED|95.0|63.7|76.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||76.3|63.7|<0.0001
73912726|NCT05248867|147355319|SUPERIORITY||Rate Difference|48.8|||<|0.0001|TWO_SIDED|95.0|42.2|55.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||55.4|42.2|<0.0001
73912727|NCT05248867|147355320|SUPERIORITY||Rate Difference|44.2|||<|0.0001|TWO_SIDED|95.0|38.0|50.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||50.4|38.0|<0.0001
73965260|NCT03351699|147465736|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.53|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 78%.|||||
73965261|NCT03351699|147465736|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.73|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 95%.|||||
74026787|NCT02396147|147607264|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|78.59|||||TWO_SIDED|90.0|52.88|116.79|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||116.79|52.88|
74026788|NCT02396147|147607264|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.23|||||TWO_SIDED|90.0|67.98|130.61|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||130.61|67.98|
73912728|NCT01960400|147355322|SUPERIORITY_OR_OTHER|||||||0.065||||||"The statistical signifiance level : p\<0.05. After treatment (T1) Pain severity p=0.065~Sub-scale:~* Present pain p=0.046\*~* Average pain p=0.381~* Most intense pain p=0.064~* Least intense pain p=0.142"|ANOVA|To assess the effectiveness of interventions (inter-group differences), a mixed-model ANOVA (time X group interaction) was used.||For the severity of pain, the calculations have revealed that only this pain now had an acceptable statistical power, of 77.1% after treatment (T1).||||0.065
73912729|NCT01960400|147355323|SUPERIORITY_OR_OTHER|||||||0.049||||||interaction group X time|ANOVA|||||||0.049
73912730|NCT01960400|147355324|SUPERIORITY_OR_OTHER|||||||0.035||||||interaction group X time|ANOVA|||||||0.035
73912731|NCT01960400|147355325|SUPERIORITY_OR_OTHER|||||||0.046||||||interaction group X time|ANOVA|||||||0.046
73912732|NCT00743483|147355341|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||t-test, 2 sided|||||||0.2179
73912733|NCT00873912|147355350|NON_INFERIORITY_OR_EQUIVALENCE|Based on similar fever rate with 300 evaluable subjects (240 vaccine and 60 placebo recipients), the study would provide at least 98% power to rule out a rate increase of 5 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 1.0%. Power would be lower if the true difference was different from zero.|rate difference|-1.3|||||TWO_SIDED|95.0|-7.9|1.3|||score statistic|||The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% CIs for rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference \< 5 percentage points.||1.3|-7.9|
73912734|NCT01466153|147355355|SUPERIORITY_OR_OTHER|||||||0.4475|||||||Cochran-Mantel-Haenszel|||||||0.4475
73912735|NCT01466153|147355359|SUPERIORITY_OR_OTHER|||||||0.3206|||||||Cochran-Mantel-Haenszel|||||||0.3206
73912736|NCT01466153|147355360|SUPERIORITY_OR_OTHER|||||||0.313|||||||Cochran-Mantel-Haenszel|||||||0.3130
73912737|NCT01466153|147355362|SUPERIORITY_OR_OTHER|||||||0.9527|||||||Log Rank|||||||0.9527
73912738|NCT05263895|147355405|OTHER||Ratio of Adjusted Geometric means|90.54|||||TWO_SIDED|90.0|79.85|102.65||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||102.65|79.85|
73912739|NCT05263895|147355405|OTHER||Ratio of Adjusted Geometric Means|102.78|||||TWO_SIDED|90.0|90.65|116.53||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||116.53|90.65|
73912740|NCT05263895|147355405|OTHER||Ratio of Adjusted Geometric Means|138.15|||||TWO_SIDED|90.0|118.03|161.69||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||161.69|118.03|
73912741|NCT05263895|147355405|OTHER||Ratio of Adjusted Geometric Means|30.8|||||TWO_SIDED|90.0|25.7|35.2||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||35.20|25.70|
73912742|NCT05263895|147355406|OTHER||Ratio of Adjusted Geometric Means|91.26|||||TWO_SIDED|90.0|80.46|103.51||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||103.51|80.46|
73912743|NCT05263895|147355406|OTHER||Ratio of Adjusted Geometric Means|102.49|||||TWO_SIDED|90.0|90.36|116.26||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||116.26|90.36|
74026789|NCT02396147|147607265|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.53|||||TWO_SIDED|90.0|74.83|119.4|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (Reference) \*100|||119.40|74.83|
74026790|NCT02396147|147607265|SUPERIORITY_OR_OTHER||Geometric Mean Ration|77.99|||||TWO_SIDED|90.0|64.29|94.61|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||94.61|64.29|
73912744|NCT05263895|147355406|OTHER||Ratio of Adjusted Geometric Means|136.99|||||TWO_SIDED|90.0|117.09|160.27||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||160.27|117.09|
73912745|NCT05263895|147355406|OTHER||Ratio of Adjusted Geometric Means|29.77|||||TWO_SIDED|90.0|25.45|34.83||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||34.83|25.45|
73912746|NCT05263895|147355407|OTHER||Ratio of Adjusted Geometric Means|94.28|||||TWO_SIDED|90.0|80.77|110.05||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||110.05|80.77|
73912747|NCT05263895|147355407|OTHER||Ratio of Adjusted Geometric Means|108.6|||||TWO_SIDED|90.0|93.04|126.76||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||126.76|93.04|
73912748|NCT05263895|147355407|OTHER||Ratio of Adjusted Geometric Means|264.12|||||TWO_SIDED|90.0|232.32|300.27||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||300.27|232.32|
73912749|NCT05263895|147355407|OTHER||Ratio of Adjusted Geometric Means|145.53|||||TWO_SIDED|90.0|128.01|165.45||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||165.45|128.01|
73912750|NCT03486223|147355422|SUPERIORITY|||||||0.71||||||Wilcoxon signed-rank test was used for the within-subject comparison of GSK2256294 versus placebo.|Wilcoxon (Mann-Whitney)|||A sample size of 16 per group was estimated to have 86% power to detect a within-subject difference of 3.76 (80% of the above difference) or larger (with an SD for the within-subject difference of 4.6) in insulin sensitivity.||||0.71
73912751|NCT01948947|147355440|OTHER||||||<|0.0001|||||||ANOVA|||Change from Baseline to 1-Week Post-Treatment||||<0.0001
74026791|NCT02396147|147607265|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|81.08|||||TWO_SIDED|90.0|64.21|102.37|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||102.37|64.21|
73912752|NCT01948947|147355440|OTHER||||||<|0.001|||||||ANOVA|||Change from Baseline to 1-Month Post-Treatment||||<0.001
73912753|NCT01948947|147355441|OTHER||||||<|0.001||||||Change from Baseline to 1-Week post-treatment|ANOVA|||||||<0.001
74026792|NCT02396147|147607265|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|92.78|||||TWO_SIDED|90.0|76.48|112.55|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||112.55|76.48|
74026793|NCT02396147|147607266|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.43|||||TWO_SIDED|90.0|74.85|119.12|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference) \* 100|||119.12|74.85|
74026794|NCT02396147|147607266|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|78.09|||||TWO_SIDED|90.0|64.53|94.51|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||94.51|64.53|
73858735|NCT04239222|147263282|SUPERIORITY|A sample size of 22 subjects was required to provide 80% power to detect a difference of 5 points on the PLUS-M scale using Wilcoxon's matched pairs signed ranks test and alpha of 0.05. A standard deviation of 7.7 was used to calculate the sample size.|Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|4.17||0.286|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot,|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean PLUS-M score using the Revo-M and μEveryday is the mean PLUS-M score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (11 negative, 8 positive and 4 null), Z=-1.066.|||0.286
73858736|NCT04239222|147263283|SUPERIORITY|A sample size of 21 subjects was required to provide 80% power to detect a difference of 0.2 points in the TAPES-AR score using Wilcoxon's matched pairs signed ranks test and alpha of 0.05. A standard deviation of 0.3 was used to calculate the sample size.|Mean Difference (Final Values)|-0.094|STANDARD_DEVIATION|0.212||0.031|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≥ μEveryday, μRevo-M is the mean TAPES-AR score using the Revo-M and μEveryday is the mean TAPES-AR score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (5 negative, 13 positive and 5 null), Z=-2.156|||0.031
73858737|NCT04239222|147263285|SUPERIORITY||Mean Difference (Final Values)|0.331|STANDARD_DEVIATION|8.29||0.421|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean ABC score using the Revo-M and μEveryday is the mean ABC score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (12 negative, 7 positive and 4 null), Z=-0.805.|||0.421
73858738|NCT04239222|147263286|SUPERIORITY||Mean Difference (Final Values)|0.087|STANDARD_DEVIATION|0.844||0.443|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean TAPES-FUN score using the Revo-M and μEveryday is the mean TAPES-FUN score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (6 negative, 9 positive and 8 null), Z=-0.767.|||0.443
73858739|NCT02240368|147263320|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||bootstrap|||||||<0.01
73858740|NCT02240368|147263321|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||bootstrap|||||||<0.01
73858741|NCT02240368|147263322|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73858742|NCT02240368|147263323|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73858743|NCT00909545|147263324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|2.03||0.9834|TWO_SIDED|95.0|-3.99|4.07||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 5mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 5mg/day arm is compared to placebo group.||4.07|-3.99|0.9834
73858744|NCT00909545|147263324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.97||0.5761|TWO_SIDED|95.0|-5.01|2.8||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 10mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 10mg/day arm is compared to placebo group.||2.80|-5.01|0.5761
73858745|NCT00909545|147263324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|2.01||0.322|TWO_SIDED|95.0|-5.98|1.99||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 20mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 20mg/day arm is compared to placebo group.||1.99|-5.98|0.322
73858746|NCT00909545|147263325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|STANDARD_ERROR_OF_MEAN|1.1587||0.1383|TWO_SIDED|95.0|0.0196|1.8411|||Fisher Exact|||The tolerability of 5mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||1.8411|0.0196|0.1383
73858747|NCT00909545|147263325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1086|STANDARD_ERROR_OF_MEAN|0.1114||0.0248|TWO_SIDED|95.0|0.0123|0.9591|||Fisher Exact|||The tolerability of 10mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||0.9591|0.0123|0.0248
73912754|NCT01948947|147355441|OTHER||||||<|0.01||||||Change from Baseline to 1-Month post-treatment|ANOVA|||||||<0.01
73912755|NCT01948947|147355442|OTHER|||||||0.009|||||||ANOVA|||||||0.009
74026795|NCT02396147|147607266|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|81.16|||||TWO_SIDED|90.0|64.36|102.34|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||102.34|64.36|
73858748|NCT00909545|147263325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.024|STANDARD_ERROR_OF_MEAN|1.1035|<|0.0001|TWO_SIDED|95.0|0.0028|0.2087|||Fisher Exact|||The tolerability of 20mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||0.2087|0.0028|<0.0001
73858749|NCT00909545|147263326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2324|TWO_SIDED|95.0|-0.3|1.22|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||1.22|-0.30|0.2324
73858750|NCT00909545|147263326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.37||1|TWO_SIDED|95.0|-0.73|0.73|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||0.73|-0.73|1
73858751|NCT00909545|147263326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.37||0.4675|TWO_SIDED|95.0|-1.02|0.47|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||0.47|-1.02|0.4675
73858752|NCT00909545|147263327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4648|TWO_SIDED|95.0|-1.03|2.23|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||2.23|-1.03|0.4648
73912756|NCT01948947|147355442|OTHER||||||<|0.01||||||Change in Baseline to 1-month post-treatment|ANOVA|||||||<0.01
73912757|NCT01948947|147355443|OTHER||||||=|0.033|||||||ANOVA|||||||=0.033
73912758|NCT01153347|147355444|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|1.07||1|TWO_SIDED|95.0|-2.96|1.24||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.24|-2.96|1.000
74026796|NCT02396147|147607266|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|92.99|||||TWO_SIDED|90.0|76.84|112.54|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||112.54|76.84|
74088362|NCT03694808|147730157|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.218|||||TWO_SIDED|95.0|0.063|0.373|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.373|0.063|
73858753|NCT00909545|147263327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.8||0.525|TWO_SIDED|95.0|-2.09|1.07|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||1.07|-2.09|0.525
73858754|NCT00909545|147263327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.81||0.3674|TWO_SIDED|95.0|-2.36|0.88|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||0.88|-2.36|0.3674
73858755|NCT00909545|147263328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|1.5||0.579|TWO_SIDED|95.0|-3.8|2.14|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||2.14|-3.80|0.579
73858756|NCT00909545|147263328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|1.46||0.7778|TWO_SIDED|95.0|-3.3|2.48|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||2.48|-3.30|0.7778
73858757|NCT00909545|147263328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|1.48||0.669|TWO_SIDED|95.0|-3.58|2.31|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||2.31|-3.58|0.669
73858758|NCT00909545|147263329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6677|TWO_SIDED|95.0|-0.27|0.17|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 5mg/day arm is compared to placebo group.||0.17|-0.27|0.6677
73858759|NCT00909545|147263329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1755|TWO_SIDED|95.0|-0.36|0.07|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 10mg/day arm is compared to placebo group.||0.07|-0.36|0.1755
73858760|NCT00909545|147263329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.1463|TWO_SIDED|95.0|-0.38|0.06|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 20mg/day arm is compared to placebo group.||0.06|-0.38|0.1463
73858761|NCT00909545|147263330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|1.4||0.7111|TWO_SIDED|95.0|-3.3|2.26|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 5mg/day arm is compared to placebo group.||2.26|-3.30|0.7111
73858762|NCT00909545|147263330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35|STANDARD_ERROR_OF_MEAN|1.36||0.3237|TWO_SIDED|95.0|-1.35|4.04|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 10mg/day arm is compared to placebo group.||4.04|-1.35|0.3237
73858763|NCT00909545|147263330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|1.4||0.3658|TWO_SIDED|95.0|-1.51|4.05|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 20mg/day arm is compared to placebo group.||4.05|-1.51|0.3658
73858764|NCT00909545|147263331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.32||0.0608|TWO_SIDED|95.0|-0.12|5.13|||ANCOVA|||Change in BDI-II of Isradipine CR 5mg/day arm is compared to placebo group.||5.13|-0.12|0.0608
73858765|NCT00909545|147263331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|1.36||0.6445|TWO_SIDED|95.0|-2.07|3.33|||ANCOVA|||Change in BDI-II of Isradipine CR 10mg/day arm is compared to placebo group.||3.33|-2.07|0.6445
73858766|NCT00909545|147263331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.52||0.1336|TWO_SIDED|95.0|-0.63|4.67|||ANCOVA|||Change in BDI-II of Isradipine CR 20mg/day arm is compared to placebo group.||4.67|-0.63|0.1336
73858767|NCT00909545|147263332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.56||0.3533|TWO_SIDED|95.0|-1.64|0.59|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 5mg/day arm is compared to placebo group.||0.59|-1.64|0.3533
73858768|NCT00909545|147263332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.56||0.4045|TWO_SIDED|95.0|-1.59|0.65|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 10mg/day arm is compared to placebo group.||0.65|-1.59|0.4045
73858769|NCT00909545|147263332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.57||0.7049|TWO_SIDED|95.0|-1.36|0.92|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 20mg/day arm is compared to placebo group.||0.92|-1.36|0.7049
73858770|NCT00909545|147263333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.19|STANDARD_ERROR_OF_MEAN|1.8||0.2278|TWO_SIDED|95.0|-1.4|5.79|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.||5.79|-1.40|0.2278
73858771|NCT00909545|147263333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.72|STANDARD_ERROR_OF_MEAN|1.86||0.356|TWO_SIDED|95.0|-1.97|5.42|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.||5.42|-1.97|0.356
73858772|NCT00909545|147263333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|1.83||0.26|TWO_SIDED|95.0|-1.56|5.71|||ANCOVA|||Change in PDQ-39 of Isradipine CR 20mg/day arm is compared to placebo group.||5.71|-1.56|0.2600
73858773|NCT00909545|147263340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2632|STANDARD_ERROR_OF_MEAN|1.159||0.1384|TWO_SIDED|95.0|0.5432|50.9977||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||The analyses is to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||50.9977|0.5432|0.1384
73912759|NCT01153347|147355444|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|1.08||1|TWO_SIDED|95.0|-2.67|1.57|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.57|-2.67|1.000
73912760|NCT01153347|147355444|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|1.09||1|TWO_SIDED|95.0|-2.26|2.04|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.04|-2.26|1.000
73912761|NCT01153347|147355445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.24||0.967|TWO_SIDED|95.0|0.64|1.6|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.60|0.64|0.967
73912762|NCT01153347|147355445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.21||0.67|TWO_SIDED|95.0|0.57|1.43|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.43|0.57|0.670
73912763|NCT01153347|147355445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87|STANDARD_ERROR_OF_MEAN|0.21||0.544|TWO_SIDED|95.0|0.54|1.38|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.38|0.54|0.544
73912764|NCT01153347|147355446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.24||0.73|TWO_SIDED|95.0|0.55|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.53|0.55|0.730
73912765|NCT01153347|147355446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.23||0.671|TWO_SIDED|95.0|0.53|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.50|0.53|0.671
73912766|NCT01153347|147355446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76|STANDARD_ERROR_OF_MEAN|0.2||0.308|TWO_SIDED|95.0|0.45|1.29|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.29|0.45|0.308
73912767|NCT01153347|147355447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|STANDARD_ERROR_OF_MEAN|0.4||0.905|TWO_SIDED|95.0|0.42|2.15|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.15|0.42|0.905
73912768|NCT01153347|147355447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.39||0.864|TWO_SIDED|95.0|0.41|2.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.14|0.41|0.864
73912769|NCT01153347|147355447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.42||0.958|TWO_SIDED|95.0|0.43|2.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.25|0.43|0.958
73912770|NCT01153347|147355448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.3||0.778|TWO_SIDED|95.0|0.48|1.73|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.73|0.48|0.778
73912771|NCT01153347|147355448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|STANDARD_ERROR_OF_MEAN|0.38||0.532|TWO_SIDED|95.0|0.66|2.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.24|0.66|0.532
73912772|NCT01153347|147355448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.29||0.633|TWO_SIDED|95.0|0.44|1.64|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.64|0.44|0.633
73912773|NCT01153347|147355449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.42||0.949|TWO_SIDED|95.0|0.46|2.31|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.31|0.46|0.949
73912774|NCT01153347|147355449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57|STANDARD_ERROR_OF_MEAN|0.62||0.253|TWO_SIDED|95.0|0.72|3.4|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||3.40|0.72|0.253
73912775|NCT01153347|147355449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|STANDARD_ERROR_OF_MEAN|0.39||0.763|TWO_SIDED|95.0|0.37|2.08|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.08|0.37|0.763
73912776|NCT01153347|147355450|SUPERIORITY_OR_OTHER||LS mean|-1.0|STANDARD_ERROR_OF_MEAN|0.78||0.207|TWO_SIDED|95.0|-2.51|0.55|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.55|-2.51|0.207
73912777|NCT01153347|147355450|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.78||0.427|TWO_SIDED|95.0|-2.16|0.91|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.91|-2.16|0.427
73912778|NCT01153347|147355450|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.78||0.591|TWO_SIDED|95.0|-1.96|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.12|-1.96|0.591
73912779|NCT01153347|147355451|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.551||95.0|-0.34|0.18|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.18|-0.34|0.551
73912780|NCT01153347|147355451|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.487|TWO_SIDED|95.0|-0.36|0.17|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.17|-0.36|0.487
73912781|NCT01153347|147355451|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.78|TWO_SIDED|95.0|-0.23|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.31|-0.23|0.780
73912782|NCT01153347|147355452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.23||0.908|TWO_SIDED|95.0|0.62|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.53|0.62|0.908
73912783|NCT01153347|147355452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06|STANDARD_ERROR_OF_MEAN|0.24||0.803|TWO_SIDED|95.0|0.67|1.67|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.67|0.67|0.803
73912784|NCT01153347|147355452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|STANDARD_ERROR_OF_MEAN|0.15||0.066|TWO_SIDED|95.0|0.41|1.03|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.03|0.41|0.066
73912785|NCT01153347|147355453|SUPERIORITY_OR_OTHER||LS mean|-0.82|STANDARD_ERROR_OF_MEAN|0.645||0.202|TWO_SIDED|95.0|-2.091|0.442|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.442|-2.091|0.202
73912786|NCT01153347|147355453|SUPERIORITY_OR_OTHER||LS mean|-0.22|STANDARD_ERROR_OF_MEAN|0.647||0.738|TWO_SIDED|95.0|-1.487|1.055|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.055|-1.487|0.738
73912787|NCT01153347|147355453|SUPERIORITY_OR_OTHER||LS mean|-0.51|STANDARD_ERROR_OF_MEAN|0.65||0.433|TWO_SIDED|95.0|-1.787|0.767|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.767|-1.787|0.433
73965262|NCT03351699|147465736|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.52|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 75%.|||||
73912788|NCT01153347|147355454|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.61||0.097|TWO_SIDED|95.0|-0.18|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-0.18|0.097
73912789|NCT01153347|147355454|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.882|TWO_SIDED|95.0|-1.29|1.11|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-1.29|0.882
73912790|NCT01153347|147355454|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.1|TWO_SIDED|95.0|-0.19|2.23|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.23|-0.19|0.100
73912791|NCT01153347|147355455|SUPERIORITY_OR_OTHER||LS mean|0.8|STANDARD_ERROR_OF_MEAN|0.74||0.303|TWO_SIDED|95.0|-0.69|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-0.69|0.303
73912792|NCT01153347|147355455|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.74||0.793|TWO_SIDED|95.0|-1.26|1.65|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.65|-1.26|0.793
74026797|NCT01466751|147607283|SUPERIORITY_OR_OTHER||Type III Tests of Fixed Effects|8.687||||0.004|TWO_SIDED|||||A-priori threshold for statistical significance: p \< 0.05. No correction for multiple comparisons. The omnibus effect from the linear mixed model for the Treatment Arm x Time Interaction was utilized to establish significance of the effect.|Mixed Models Analysis|Numerator degrees of freedom=1, Denominator degrees of freedom = 168||A linear mixed model was utilized to test the null hypothesis that the intervention groups would show equivalent performance change on the outcome measure from baseline to the 3 month time points.||||0.004
73858774|NCT00909545|147263340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.625|STANDARD_ERROR_OF_MEAN|1.097||0.0024|TWO_SIDED|95.0|1.8214|134.0403||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||134.0403|1.8214|0.0024
73858775|NCT00909545|147263340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|50.0|STANDARD_ERROR_OF_MEAN|1.108|<|0.0001|TWO_SIDED|95.0|5.7004|438.5694||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||438.5694|5.7004|<.0001
73858776|NCT00909545|147263341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.754|STANDARD_ERROR_OF_MEAN|0.6715||0.7735|TWO_SIDED|95.0|0.2022|2.812|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||2.8120|0.2022|0.7735
73858777|NCT00909545|147263341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8143|STANDARD_ERROR_OF_MEAN|0.6419||0.7385|TWO_SIDED|95.0|0.2314|2.8658|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||2.8658|0.2314|0.7385
73858778|NCT00909545|147263341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9048|STANDARD_ERROR_OF_MEAN|0.6463||0.6823|TWO_SIDED|95.0|0.2549|3.2112|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||3.2112|0.2549|0.6823
73858779|NCT00909545|147263342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5263|STANDARD_ERROR_OF_MEAN|0.9188||0.2756|TWO_SIDED|95.0|0.4172|15.2975|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||15.2975|0.4172|0.2756
73858780|NCT00909545|147263342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4211|STANDARD_ERROR_OF_MEAN|0.8584||0.07|TWO_SIDED|95.0|0.8217|23.7875|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||23.7875|0.8217|0.07
73858781|NCT00909545|147263342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|STANDARD_ERROR_OF_MEAN|0.9174||0.2953|TWO_SIDED|95.0|0.3975|14.4919|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||14.4919|0.3975|0.2953
73858782|NCT00909545|147263343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|STANDARD_ERROR_OF_MEAN|0.8719||0.6049|TWO_SIDED|95.0|0.2082|6.3508|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||6.3508|0.2082|0.6049
73858783|NCT00909545|147263343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|STANDARD_ERROR_OF_MEAN|0.7704||0.2327|TWO_SIDED|95.0|0.5081|10.4105|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||10.4105|0.5081|0.2327
73858784|NCT00909545|147263343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5333|STANDARD_ERROR_OF_MEAN|0.8227||0.4534|TWO_SIDED|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||7.6897|0.3057|0.4534
73858785|NCT00909545|147263344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||4.8065|0.1109|0.7852
73858786|NCT00909545|147263344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.8681||0.666|TWO_SIDED|95.0|0.1824|5.482|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||5.4820|0.1824|0.666
73858787|NCT00909545|147263344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5333|STANDARD_ERROR_OF_MEAN|0.8227||0.4534|TWO_SIDED|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||7.6897|0.3057|0.4534
73858788|NCT00909545|147263345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5455|STANDARD_ERROR_OF_MEAN|1.2596||0.8589|TWO_SIDED|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||6.4433|0.0462|0.8589
73858789|NCT00909545|147263345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5652|STANDARD_ERROR_OF_MEAN|0.9584||0.5|TWO_SIDED|95.0|0.2392|10.241|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||10.2410|0.2392|0.5000
73858790|NCT00909545|147263345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7143|STANDARD_ERROR_OF_MEAN|0.9605||0.4609|TWO_SIDED|95.0|0.2609|11.2639|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||11.2639|0.2609|0.4609
73912793|NCT01153347|147355455|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.75||0.762|TWO_SIDED|95.0|-1.7|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.25|-1.70|0.762
73912794|NCT01153347|147355456|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|0.91||0.339|TWO_SIDED|95.0|-2.65|0.92|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.92|-2.65|0.339
73912795|NCT01153347|147355456|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|0.91||0.321|TWO_SIDED|95.0|-2.7|0.89|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.89|-2.70|0.321
73912796|NCT01153347|147355456|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.92||0.68|TWO_SIDED|95.0|-2.2|1.43|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.43|-2.20|0.680
73912797|NCT01153347|147355457|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.97||0.737|TWO_SIDED|95.0|-2.23|1.58|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||1.58|-2.23|0.737
73912798|NCT01153347|147355457|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.98||0.547|TWO_SIDED|95.0|-2.52|1.33|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.33|-2.52|0.547
73912799|NCT01153347|147355457|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.99||0.953|TWO_SIDED|95.0|-1.89|2.01|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.01|-1.89|0.953
73912800|NCT01153347|147355458|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.746||1|TWO_SIDED|95.0|-2.069|0.864||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.864|-2.069|1.000
73912801|NCT01153347|147355458|SUPERIORITY_OR_OTHER||LS mean|-0.52|STANDARD_ERROR_OF_MEAN|0.755||1|TWO_SIDED|95.0|-2.004|0.96||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.960|-2.004|1.000
73912802|NCT01153347|147355458|SUPERIORITY_OR_OTHER||LS mean|0.4|STANDARD_ERROR_OF_MEAN|0.761||1|TWO_SIDED|95.0|-1.095|1.896||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.896|-1.095|1.000
73912803|NCT01153347|147355459|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.953|TWO_SIDED|95.0|-0.56|0.59|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.59|-0.56|0.953
74085580|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.3|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||1.3|0.7|
74085581|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.8|2.0|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.0|0.8|
73912804|NCT01153347|147355459|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.868|TWO_SIDED|95.0|-0.64|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.54|-0.64|0.868
73912805|NCT01153347|147355459|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.792|TWO_SIDED|95.0|-0.5|0.66|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.66|-0.50|0.792
73912806|NCT01153347|147355460|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.915|TWO_SIDED|95.0|-0.54|0.48|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.48|-0.54|0.915
73912807|NCT01153347|147355460|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.972|TWO_SIDED|95.0|-0.51|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.53|-0.51|0.972
73912808|NCT01153347|147355460|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.237|TWO_SIDED|95.0|-0.21|0.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.84|-0.21|0.237
73912809|NCT01153347|147355461|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.213|TWO_SIDED|95.0|-0.87|0.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.19|-0.87|0.213
73912810|NCT01153347|147355461|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.343|TWO_SIDED|95.0|-0.8|0.28|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.28|-0.80|0.343
74085582|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.5|3.4|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of ibandronate~compared to non-initiators of ibandronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||3.4|0.5|
74085583|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risendronate~compared to non-initiators of risendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.0|0.9|
73912811|NCT01153347|147355461|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.971|TWO_SIDED|95.0|-0.55|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.53|-0.55|0.971
73912812|NCT01153347|147355462|SUPERIORITY_OR_OTHER||LS mean|2.1|STANDARD_ERROR_OF_MEAN|1.694||0.215|TWO_SIDED|95.0|-1.224|5.431|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||5.431|-1.224|0.215
73912813|NCT01153347|147355462|SUPERIORITY_OR_OTHER||LS mean|0.72|STANDARD_ERROR_OF_MEAN|1.702||0.673|TWO_SIDED|95.0|-2.624|4.062|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||4.062|-2.624|0.673
74085584|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.3|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.3|0.3|
73912814|NCT01153347|147355462|SUPERIORITY_OR_OTHER||LS mean|-1.88|STANDARD_ERROR_OF_MEAN|1.716||0.275|TWO_SIDED|95.0|-5.248|1.494|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.494|-5.248|0.275
73912815|NCT01153347|147355463|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.412|TWO_SIDED|95.0|-0.28|0.11|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.11|-0.28|0.412
74085585|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.5|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~alendronate compared to non-initiators of alendronate. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||1.5|0.7|
73912816|NCT01153347|147355463|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.928|TWO_SIDED|95.0|-0.19|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.21|-0.19|0.928
73912817|NCT01153347|147355463|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.42|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||-0.02|-0.42|0.033
73912818|NCT01153347|147355464|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.353|TWO_SIDED|95.0|-0.1|0.28|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.28|-0.10|0.353
73912819|NCT01153347|147355464|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.721|TWO_SIDED|95.0|-0.16|0.23|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.23|-0.16|0.721
73912820|NCT01153347|147355464|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.666|TWO_SIDED|95.0|-0.24|0.15|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.15|-0.24|0.666
73965263|NCT03351699|147465736|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.75|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 96%.|||||
73965264|NCT02570022|147465763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||t-test, 2 sided||This analysis corresponds to the visual analog scale and morphine equivalent data.|Our hypothesis was that in patients undergoing shoulder arthroplasty, treatment with LB would lead to no significant differences in average daily pain scores. A power analysis was performed prior to the study to assess the primary hypothesis that a significant difference in average daily pain of 13mm on VAS will not be found between the INB and LB groups. With a power of 80% (beta level = 0.80, alpha level = 0.05), a sample size of 25 patients per group was obtained||||<0.05
73965265|NCT00041938|147465765|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.4|TWO_SIDED|95.0|0.79|1.1||The primary null hypotheses was tested at two-tailed alpha=0.05. A Haybittle-Peto interim monitoring procedure was performed with stopping boundaries for the interim analyses corresponding to a nominal two-tailed P value of 0.001.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|The primary null hypothesis: time to first event in the composite primary endpoint does not differ significantly between warfarin and aspirin. The original target sample size was 2860, providing 89% power for a log-rank test with two-sided alpha .05, assuming a hazard rate reduction of 17.82% in either group compared with the other, after adjustment for use of beta-blockers and allowance for discontinuation of therapy, dropout, and crossover. The final sample of 2305 patients yielded 69% power.||1.10|0.79|0.40
74026798|NCT01466751|147607284|SUPERIORITY_OR_OTHER||Type III Tests of Fixed Effects|2.032||||0.156|TWO_SIDED|||||No adjustment for multiple comparisons. The a priori threshold was: p \< 0.05.|Mixed Models Analysis|Numerator degrees of freedom: 1, Denominator degrees of freedom: 168||A linear mixed model was used to test the null hypothesis that the two treatment groups would display no differential changes in amygdala BOLD signal from baseline to 3 months as a main effect or in interaction with facial affect type (fear or happy) or by brain hemisphere (left or right).||||0.156
74026799|NCT04328623|147607287|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74026800|NCT00849693|147607288|SUPERIORITY_OR_OTHER|||||||0.193||95.0|||||Mixed Models Analysis|||||||0.193
74026801|NCT00634543|147607301|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if lower confidence limit of 2-sided 95% CI was less than the non-inferiority margin of 1.39.|Mean Difference (Net)|0.39||||0.2143|TWO_SIDED|95.0|-0.23|1.01|||t-test, 2 sided|P-value was calculated for change from baseline in pain intensity score at Day 43.||||1.01|-0.23|0.2143
74026802|NCT00634543|147607302|SUPERIORITY_OR_OTHER|||||||0.7539|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 15.||||||0.7539
74026803|NCT00634543|147607302|SUPERIORITY_OR_OTHER|||||||0.5905|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 29.||||||0.5905
73858791|NCT00909545|147263346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||4.8065|0.1109|0.7852
73858792|NCT00909545|147263346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||3.1612|0.0297|0.9448
73858793|NCT00909545|147263346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.697|STANDARD_ERROR_OF_MEAN|0.9604||0.7996|TWO_SIDED|95.0|0.1061|4.5779|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||4.5779|0.1061|0.7996
73858794|NCT00909545|147263347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.381|STANDARD_ERROR_OF_MEAN|1.2599||0.4532|TWO_SIDED|95.0|0.2015|28.1366|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.||28.1366|0.2015|0.4532
73858795|NCT00909545|147263347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.9524|STANDARD_ERROR_OF_MEAN|1.1347||0.0953|TWO_SIDED|95.0|0.6439|55.0272|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.||55.0272|0.6439|0.0953
73858796|NCT00909545|147263348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402||95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||11.8558|0.2733|0.4402
73858797|NCT00909545|147263348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|1.2577||0.8824|TWO_SIDED|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||5.6461|0.0408|0.8824
74026804|NCT00634543|147607302|SUPERIORITY_OR_OTHER|||||||0.7407|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 43.||||||0.7407
74026805|NCT00634543|147607303|SUPERIORITY_OR_OTHER|||||||0.3504|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).||||||0.3504
74026806|NCT00634543|147607304|SUPERIORITY_OR_OTHER|||||||0.569|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).||||||0.5690
73912821|NCT01153347|147355465|SUPERIORITY_OR_OTHER||LS mean|-0.006|STANDARD_ERROR_OF_MEAN|0.0201||0.747|TWO_SIDED|95.0|-0.0459|0.0329||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0329|-0.0459|0.747
73912822|NCT01153347|147355465|SUPERIORITY_OR_OTHER||LS mean|-0.013|STANDARD_ERROR_OF_MEAN|0.0203||0.524|TWO_SIDED|95.0|-0.0529|0.027||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0270|-0.0529|0.524
73912823|NCT01153347|147355465|SUPERIORITY_OR_OTHER||LS mean|-0.014|STANDARD_ERROR_OF_MEAN|0.0206||0.502|TWO_SIDED|95.0|-0.0543|0.0267||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0267|-0.0543|0.502
73912824|NCT01153347|147355465|SUPERIORITY_OR_OTHER||LS mean|1.9|STANDARD_ERROR_OF_MEAN|2.06||0.345|TWO_SIDED|95.0|-2.1|6.0||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||6.00|-2.10|0.345
73912825|NCT01153347|147355465|SUPERIORITY_OR_OTHER||LS mean|1.5|STANDARD_ERROR_OF_MEAN|2.09||0.486|TWO_SIDED|95.0|-2.65|5.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||5.56|-2.65|0.486
73912826|NCT01153347|147355465|SUPERIORITY_OR_OTHER||LS mean|-1.2|STANDARD_ERROR_OF_MEAN|2.12||0.564|TWO_SIDED|95.0|-5.39|2.94||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.94|-5.39|0.564
73912827|NCT01153347|147355466|SUPERIORITY_OR_OTHER||LS mean|-1.4|STANDARD_ERROR_OF_MEAN|1.55||0.35|TWO_SIDED|95.0|-4.48|1.59|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.59|-4.48|0.350
73912828|NCT01153347|147355466|SUPERIORITY_OR_OTHER||LS mean|-1.3|STANDARD_ERROR_OF_MEAN|1.56||0.393|TWO_SIDED|95.0|-4.41|1.73|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.73|-4.41|0.393
73912829|NCT01153347|147355466|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|1.58||0.745|TWO_SIDED|95.0|-2.59|3.62|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||3.62|-2.59|0.745
73912830|NCT05096221|147355474|SUPERIORITY||Least squares mean change difference|0.65|STANDARD_ERROR_OF_MEAN|0.55||0.2441|TWO_SIDED|95.0|-0.45|1.74|||Mixed model of repeated measures|||||1.74|-0.45|0.2441
73912831|NCT05096221|147355475|OTHER||||||<|0.0001|||||||Re-randomization test|||||||< 0.0001
73965266|NCT00041938|147465766|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.33|TWO_SIDED|95.0|0.93|1.23||Secondary null hypothesis was tested at two-tailed alpha = 0.05.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Secondary null hypothesis: time to first event in the composite secondary endpoint does not differ significantly between warfarin and aspirin. This was tested at prespecified alpha = 0.05 level, two-tailed.||1.23|0.93|0.33
73965267|NCT00041938|147465767|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.005|TWO_SIDED|95.0|0.33|0.82|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of death and intracerebral hemorrhage.||0.82|0.33|0.005
73912832|NCT05096221|147355476|SUPERIORITY||Least squares mean change difference|-0.64|STANDARD_ERROR_OF_MEAN|0.21||0.0025|TWO_SIDED|95.0|-1.06|-0.23|||Mixed model of repeated measures|||||-0.23|-1.06|0.0025
73965268|NCT00041938|147465768|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.22||||0.35||95.0|0.43|11.66|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of death and ischemic stroke.||11.66|0.43|0.35
73965269|NCT00041938|147465769|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.91|TWO_SIDED|95.0|0.85|1.2|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|||1.20|0.85|0.91
73912833|NCT05096221|147355477|SUPERIORITY||Least squares mean change difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.0048|TWO_SIDED|95.0|-0.71|-0.13|||Mixed model of repeated measures|||||-0.13|-0.71|0.0048
73912834|NCT05096221|147355478|SUPERIORITY||Least squares mean change difference|-3.29|STANDARD_ERROR_OF_MEAN|2.52||0.1942|TWO_SIDED|95.0|-8.28|1.7|||Mixed model of repeated measures|||||1.70|-8.28|0.1942
73912835|NCT05096221|147355479|SUPERIORITY||Least squares mean change difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0412|TWO_SIDED|95.0|-0.71|-0.01|||Mixed model of repeated measures|||||-0.01|-0.71|0.0412
73912836|NCT05096221|147355480|SUPERIORITY||Least squares mean change difference|0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0402|TWO_SIDED|95.0|0.0|0.19|||Mixed model of repeated measures|||||0.19|0.00|0.0402
73965270|NCT00041938|147465770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.93|TWO_SIDED|95.0|0.58|1.64|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to myocardial infarction, adjusting for competing risks of heart failure hospitalization, ischemic stroke, intracerebral hemorrhage, and death.||1.64|0.58|0.93
73965271|NCT00041938|147465771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.053|TWO_SIDED|95.0|0.998|1.47|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to heart failure hospitalization, adjusting for competing risks of myocardial infarction, ischemic stroke, intracerebral hemorrhage, and death.||1.47|0.998|0.053
74085586|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|1.9|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~etidronate compared to non-initiators of etidronate. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||1.9|0.7|
74085587|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.0|||||TWO_SIDED|95.0|0.8|11.1|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~ibandronate compared to non-initiators of ibandronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||11.1|0.8|
73965272|NCT00041938|147465772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.03|TWO_SIDED|95.0|0.32|0.96|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of myocardial infarction, heart failure hospitalization, death and intracerebral hemorrhage.||0.96|0.32|0.03
73965273|NCT00041938|147465773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.77||||0.51|TWO_SIDED|95.0|0.32|9.88|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of myocardial infarction, heart failure hospitalization, ischemic stroke, and death.||9.88|0.32|0.51
73965274|NCT00041938|147465774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.83||95.0|0.81|1.3|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||||1.30|0.81|0.83
73965275|NCT00041938|147465775|SUPERIORITY_OR_OTHER||Rate ratio|2.05|||<|0.001|TWO_SIDED|95.0|1.36|3.12|||Regression, Poisson||The warfarin arm represents the numerator and the aspirin arm represents the denominator of the rate ratio.|||3.12|1.36|<0.001
73912837|NCT05096221|147355481|SUPERIORITY||Least squares mean change difference|0.05|STANDARD_ERROR_OF_MEAN|0.07||0.4272|TWO_SIDED|95.0|-0.08|0.19|||Mixed model of repeated measures|||||0.19|-0.08|0.4272
73912838|NCT05096221|147355482|SUPERIORITY||Least squares mean change difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7324|TWO_SIDED|95.0|-0.24|0.17|||Mixed model of repeated measures|||||0.17|-0.24|0.7324
73912839|NCT05096221|147355483|SUPERIORITY||Least squares mean change difference|0.19|STANDARD_ERROR_OF_MEAN|0.44||0.6554|TWO_SIDED|95.0|-0.67|1.06|||Mixed model of repeated measures|||||1.06|-0.67|0.6554
73912840|NCT04678661|147355487|SUPERIORITY|||||||0.207||||||Propensity score matching was used to form pairs of intervention and control participants. Specifically, a greedy matching procedure with a matching caliper of 0.2 of the standard deviation of the logit of the propensity score was used.|Regression, Linear|Model adjusted for covariates of age, race, baseline BMI, and baseline hemoglobin A1c.||||||.207
73912841|NCT04678661|147355488|OTHER|||||||0.011|||||||t-test, 2 sided|||Independent t-test||||.011
73912842|NCT04678661|147355489|OTHER|||||||0.024|||||||t-test, 2 sided|||||||.024
73912843|NCT04678661|147355490|OTHER|||||||0.579|||||||t-test, 2 sided|||||||.579
73912844|NCT04678661|147355491|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
73912845|NCT04678661|147355492|OTHER|||||||0.269|||||||t-test, 2 sided|||||||.269
73912846|NCT04678661|147355495|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
73912847|NCT04678661|147355496|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
73965276|NCT00041938|147465776|SUPERIORITY_OR_OTHER||Rate ratio|1.56|||<|0.001||95.0|1.34|1.81|||Regression, Poisson||Warfarin group represents the numerator and aspirin group represents denominator of rate ratio.|||1.81|1.34|<0.001
73965277|NCT03087708|147465837|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<1
73965278|NCT03087708|147465837|OTHER||||||<|0.7051|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.7051
73965279|NCT03087708|147465837|OTHER||||||<|0.6546|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<0.6546
73965280|NCT03087708|147465837|OTHER||||||<|0.7051|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.7051
74085588|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.8|||||TWO_SIDED|95.0|1.1|3.0|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~risedronate compared to non-initiators of risedronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||3.0|1.1|
74085589|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.1|2.7|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~raloxifene compared to non-initiators of raloxifene. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||2.7|0.1|
74085590|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.6|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||1.6|0.5|
73858798|NCT00909545|147263348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0909|STANDARD_ERROR_OF_MEAN|1.0428||0.6641|TWO_SIDED|95.0|0.1413|8.4197|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||8.4197|0.1413|0.6641
73858799|NCT00909545|147263349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402|TWO_SIDED|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.||11.8558|0.2733|0.4402
73858800|NCT00909545|147263349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0409||0.6951|TWO_SIDED|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.||7.6906|0.1300|0.6951
73858801|NCT00909545|147263350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402|TWO_SIDED|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||11.8558|0.2733|0.4402
73858802|NCT00909545|147263350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|1.2577||0.8824|TWO_SIDED|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||5.6461|0.0408|0.8824
73858803|NCT00909545|147263350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5217|STANDARD_ERROR_OF_MEAN|1.2594||0.8673|TWO_SIDED|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||6.1537|0.0442|0.8673
73858804|NCT00909545|147263351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3485|STANDARD_ERROR_OF_MEAN|1.1919||0.9294|TWO_SIDED|95.0|0.0337|3.6084|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.6084|0.0337|0.9294
73858805|NCT00909545|147263351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.1612|0.0297|0.9448
73858806|NCT00909545|147263351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3333|STANDARD_ERROR_OF_MEAN|1.1924||0.9351|TWO_SIDED|95.0|0.0322|3.4459|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.4459|0.0322|0.9351
73858807|NCT00909545|147263352|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5455|STANDARD_ERROR_OF_MEAN|1.2596||0.8589|TWO_SIDED|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||6.4433|0.0462|0.8589
73858808|NCT00909545|147263352|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0409||0.6951|TWO_SIDED|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||7.6906|0.1300|0.6951
73858809|NCT00909545|147263352|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5217|STANDARD_ERROR_OF_MEAN|1.2594||0.8673|TWO_SIDED|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||6.1537|0.0442|0.8673
73858810|NCT00909545|147263353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.||4.8065|0.1109|0.7852
73912848|NCT04678661|147355497|OTHER|||||||0.647|||||||t-test, 2 sided|||||||.647
73912849|NCT04645953|147355510|SUPERIORITY|||||||0.7024|||||||ANOVA|||Null hypothesis is there was no difference between groups treated with AZ-010 (1 mg or 3 mg) and the placebo group in the mean number of vomiting/retching events in the 2 hours following. treatment. Baseline, body weight, height, body mass index, age as covariates, and the treatment group and study site as factors. All statistical tests were 2-sided with a significance value of ≤ 0.05.||||0.7024
73965281|NCT03087708|147465837|OTHER||||||<|0.2262|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.2262
73965282|NCT03087708|147465837|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<1
73965283|NCT03087708|147465837|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<1
74085591|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.6|2.0||Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.|Proportional hazards regression model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||2.0|0.6|
74085592|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.4|2.5|||Proportional hazards regression model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risedronate~compared to non-initiators of risedronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||2.5|0.4|
73858811|NCT00909545|147263353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.||3.1612|0.0297|0.9448
73858812|NCT00909545|147263354|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0833|STANDARD_ERROR_OF_MEAN|1.2576||0.5|TWO_SIDED|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.||24.5057|0.1771|0.5000
73858813|NCT00909545|147263354|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5714|STANDARD_ERROR_OF_MEAN|1.192||0.2746|TWO_SIDED|95.0|0.3453|36.9408|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.||36.9408|0.3453|0.2746
73858814|NCT00909545|147263355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1364|STANDARD_ERROR_OF_MEAN|1.4444||0.7236|TWO_SIDED|95.0|0.067|19.264|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||19.2640|0.0670|0.7236
73858815|NCT00909545|147263355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0833|STANDARD_ERROR_OF_MEAN|1.2576||0.5|TWO_SIDED|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||24.5057|0.1771|0.5000
73858816|NCT00909545|147263355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2727|STANDARD_ERROR_OF_MEAN|1.2592||0.4694|TWO_SIDED|95.0|0.1926|26.8124|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||26.8124|0.1926|0.4694
73858817|NCT02752958|147263359|OTHER||Mean Difference (Final Values)|5.89||||0.0944|TWO_SIDED|95.0|-1.018|12.8|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus Week 4 score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (Baseline ) versus (vs.) Week 4||12.80|-1.018|0.0944
73858818|NCT02752958|147263360|OTHER||Mean Difference (Final Values)|16.99|||<|0.0001|TWO_SIDED|95.0|10.128|23.849|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 8||23.849|10.128|<0.0001
73858819|NCT02752958|147263361|OTHER||Mean Difference (Final Values)|22.7|||<|0.0001|TWO_SIDED|95.0|15.87|29.539|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 12||29.539|15.870|<0.0001
73858820|NCT02752958|147263362|OTHER||Mean Difference (Final Values)|27.21|||<|0.0001|TWO_SIDED|95.0|20.245|34.165|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 16||34.165|20.245|<0.0001
73858821|NCT02752958|147263363|OTHER||Mean Difference (Final Values)|31.42|||<|0.0001|TWO_SIDED|95.0|24.464|38.385|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.||Week 0 Vs Week 20||38.385|24.464|<.0001
73858822|NCT02752958|147263364|OTHER||Mean Difference (Final Values)|32.55|||<|0.0001|TWO_SIDED|95.0|25.585|39.506|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 24||39.506|25.585|<.0001
73858823|NCT02752958|147263365|OTHER||Mean Difference (Final Values)|1.18||||0.0312|TWO_SIDED|95.0|0.108|2.262|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 4||2.262|0.108|0.0312
73858824|NCT02752958|147263366|OTHER||Mean Difference (Final Values)|2.8|||<|0.0001|TWO_SIDED|95.0|1.728|3.866|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8||3.866|1.728|<.0001
73858825|NCT02752958|147263367|OTHER||Mean Difference (Final Values)|3.26|||<|0.0001|TWO_SIDED|95.0|2.192|4.322|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12||4.322|2.192|<.0001
73965284|NCT03087708|147465841|OTHER||||||<|0.68182|||||||Fisher Exact|||||||<0.68182
73912850|NCT04645953|147355510|SUPERIORITY|Null hypothesis is there was no difference between groups treated with AZ-010 (1 mg or 3 mg) and the placebo group in the mean number of vomiting/retching events in the 2 hours following. treatment. Baseline, body weight, height, body mass index, age as covariates, and the treatment group and study site as factors. Patients summarized by actual treatment received. Formal statistical tests (ANOVA, when performed) were 2-sided t-tests with a significance value of 0.05.||||||0.2051|||||||ANOVA|||||||0.2051
73912851|NCT04645953|147355511|SUPERIORITY|||||||0.0504|||||||Mixed Models Analysis|||Participants were asked to rate their anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||0.0504
73912852|NCT04645953|147355511|SUPERIORITY|Participants were asked to rate their anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||||0.8246|||||||Mixed Models Analysis|||||||0.8246
73965285|NCT03087708|147465841|OTHER||||||<|0.1091|||||||Fisher Exact|||||||<0.1091
73858826|NCT02752958|147263368|OTHER||Mean Difference (Final Values)|3.93|||<|0.0001|TWO_SIDED|95.0|2.844|5.012|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||5.012|2.844|<.0001
73858827|NCT02752958|147263369|OTHER||Mean Difference (Final Values)|4.15|||<|0.0001|TWO_SIDED|95.0|3.063|5.232|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||5.232|3.063|<.0001
73858828|NCT02752958|147263370|OTHER||Mean Difference (Final Values)|4.74|||<|0.0001|TWO_SIDED|95.0|3.654|5.823|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||5.823|3.654|<.0001
73858829|NCT02752958|147263371|OTHER||Mean Difference (Final Values)|1.11||||0.4185|TWO_SIDED|95.0|-1.592|3.821|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 4||3.821|-1.592|0.4185
73858830|NCT02752958|147263372|OTHER||Mean Difference (Final Values)|7.08|||<|0.0001|TWO_SIDED|95.0|4.391|9.764|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||9.764|4.391|<.0001
73858831|NCT02752958|147263373|OTHER||Mean Difference (Final Values)|8.35|||<|0.0001|TWO_SIDED|95.0|5.674|11.026|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 12||11.026|5.674|<.0001
73858832|NCT02752958|147263374|OTHER|Week 0 Vs Week 16|Mean Difference (Final Values)|10.43|||<|0.0001|TWO_SIDED|95.0|7.708|13.158|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||13.158|7.708|<.0001
73858833|NCT02752958|147263375|OTHER||Mean Difference (Final Values)|11.73|||<|0.0001|TWO_SIDED|95.0|9.008|14.459|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||14.459|9.008|<.0001
73858834|NCT02752958|147263376|OTHER||Mean Difference (Final Values)|11.96|||<|0.0001|TWO_SIDED|95.0|9.235|14.686|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||14.686|9.235|<.0001
73858835|NCT02752958|147263377|OTHER||Mean Difference (Final Values)|0.57||||0.3415|TWO_SIDED|95.0|-0.604|1.738|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 4||1.738|-0.604|0.3415
73858836|NCT02752958|147263378|OTHER||Mean Difference (Final Values)|1.77||||0.0029|TWO_SIDED|95.0|0.61|2.935|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 8||2.935|0.610|0.0029
73912853|NCT04645953|147355512|SUPERIORITY|||||||0.8299||||||Prior Episode Duration 1mg AZ-010|Mixed Models Analysis|||||||0.8299
73912854|NCT04645953|147355512|SUPERIORITY|||||||0.2346||||||Prior Episode Duration 3 mg AZ-010|Mixed Models Analysis|||||||0.2346
73965286|NCT03087708|147465842|OTHER||||||<|1|||||||Wilcoxon (Mann-Whitney)|||||||<1.0
73912855|NCT04645953|147355512|SUPERIORITY|||||||0.3997||||||Prior Episode intensity 1mg AZ-010|Mixed Models Analysis|||||||0.3997
73912856|NCT04645953|147355512|SUPERIORITY|||||||0.3997||||||Prior Episode intensity 3mg AZ-010|Mixed Models Analysis|||||||0.3997
73912857|NCT04645953|147355513|SUPERIORITY|||||||0.3847|||||||Mantel Haenszel|||||||0.3847
73912858|NCT04645953|147355513|SUPERIORITY|||||||0.1785|||||||Mantel Haenszel|||||||0.1785
73912859|NCT04645953|147355514|SUPERIORITY|||||||0.9732|||||||Mantel Haenszel|||||||0.9732
73965287|NCT03087708|147465842|OTHER||||||<|0.3339|||||||Wilcoxon (Mann-Whitney)|||||||<0.3339
73965288|NCT03087708|147465843|OTHER||||||<|0.593|||||||Wilcoxon (Mann-Whitney)|||||||<0.5930
73965289|NCT03087708|147465843|OTHER||||||<|0.3105|||||||Wilcoxon (Mann-Whitney)|||||||<0.3105
73858837|NCT02752958|147263379|OTHER||Mean Difference (Final Values)|2.42|||<|0.0001|TWO_SIDED|95.0|1.266|3.582|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||3.582|1.266|<0.0001
73858838|NCT02752958|147263380|OTHER||Mean Difference (Final Values)|3.55|||<|0.0001|TWO_SIDED|95.0|2.371|4.729|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16||4.729|2.371|<.0001
73858839|NCT02752958|147263381|OTHER||Mean Difference (Final Values)|4.39|||<|0.0001|TWO_SIDED|95.0|3.21|5.568|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||5.568|3.210|<0.0001
73858840|NCT02752958|147263382|OTHER||Mean Difference (Final Values)|4.3|||<|0.0001|TWO_SIDED|95.0|3.119|5.477|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||5.477|3.119|<0.0001
73858841|NCT02752958|147263383|OTHER||Mean Difference (Final Values)|2.42||||0.0145|TWO_SIDED|95.0|0.483|4.352|||ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||4.352|0.483|0.0145
73858842|NCT02752958|147263384|OTHER||Mean Difference (Final Values)|4.42|||<|0.0001|TWO_SIDED|95.0|2.498|6.339|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||6.339|2.498|<0.0001
73858843|NCT02752958|147263385|OTHER||Mean Difference (Final Values)|6.85|||<|0.0001|TWO_SIDED|95.0|4.933|8.759|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||8.759|4.933|<0.0001
73858844|NCT02752958|147263386|OTHER||Mean Difference (Final Values)|7.17|||<|0.0001|TWO_SIDED|95.0|5.219|9.115|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||9.115|5.219|<.0001
73858845|NCT02752958|147263387|OTHER||Mean Difference (Final Values)|8.39|||<|0.0001|TWO_SIDED|95.0|6.438|10.335|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||10.335|6.438|<0.0001
73858846|NCT02752958|147263388|OTHER||Mean Difference (Final Values)|8.67|||<|0.0001|TWO_SIDED|95.0|6.726|10.623|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 24||10.623|6.726|<0.0001
73858847|NCT02752958|147263389|OTHER||Mean Difference (Final Values)|0.63||||0.3676|TWO_SIDED|95.0|-0.738|1.989|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.989|-0.738|0.3676
73858848|NCT02752958|147263390|OTHER||Mean Difference (Final Values)|0.9||||0.1907|TWO_SIDED|95.0|-0.451|2.255|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8||2.255|-0.451|0.1907
73858849|NCT02752958|147263391|OTHER||Mean Difference (Final Values)|1.81||||0.0085|TWO_SIDED|95.0|0.467|3.162|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12||3.162|0.467|0.0085
73858850|NCT02752958|147263392|OTHER||Mean Difference (Final Values)|2.12||||0.0026|TWO_SIDED|95.0|0.744|3.489|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16||3.489|0.744|0.0026
74088363|NCT03694808|147730157|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.008|||||TWO_SIDED|95.0|-0.139|0.123|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.123|-0.139|
73858851|NCT02752958|147263393|OTHER||Mean Difference (Final Values)|2.74||||0.0001|TWO_SIDED|95.0|1.371|4.116|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.||Week 0 Vs Week 20||4.116|1.371|0.0001
73912860|NCT04645953|147355514|SUPERIORITY|||||||0.1471|||||||Mantel Haenszel|||||||0.1471
73912861|NCT04645953|147355515|SUPERIORITY|||||||0.1337|||||||ANOVA|||The RINVR is an 8-part questionnaire with each item scored from 0-4, for a total scoring range of 0-32. A lower score indicates less distress related to nausea, vomiting, and retching. The data shown is collected within the first 24 hours after the first at-home dose.||||0.1337
73912862|NCT04645953|147355515|SUPERIORITY|||||||0.7224|||||||ANOVA|||||||0.7224
73912863|NCT04645953|147355516|SUPERIORITY|||||||0.0504|||||||Mixed Models Analysis|||Participants were asked to rate their abdominal pain, nausea, and anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||0.0504
73912864|NCT04645953|147355516|SUPERIORITY|||||||0.8246|||||||Mixed Models Analysis|||||||0.8246
73912865|NCT04645953|147355517|SUPERIORITY|||||||0.9664|||||||Mixed Models Analysis|||||||0.9664
73912866|NCT04645953|147355517|SUPERIORITY|||||||0.7919|||||||Mixed Models Analysis|||||||0.7919
73912867|NCT04613375|147355518|OTHER||Adjusted VE|16.91||||0.3685|TWO_SIDED|95.0|-24.43|44.52|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with respiratory syncytial virus (RSV) infection.|||44.52|-24.43|0.3685
73912868|NCT04613375|147355519|OTHER||Adjusted VE|49.27||||0.0817|TWO_SIDED|95.0|-8.9|76.37|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\<2 years||76.37|-8.9|0.0817
73912869|NCT04613375|147355519|OTHER||Adjusted VE|4.72||||0.8367|TWO_SIDED|95.0|-50.96|39.87|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|2 years to \<5 years||39.87|-50.96|0.8367
73912870|NCT04613375|147355519|OTHER||Adjusted VE|12.02||||0.7469|TWO_SIDED|95.0|-91.53|59.59|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\>=5 years||59.59|-91.53|0.7469
73965290|NCT03087708|147465844|OTHER|||||||0.6024|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at Baseline||||0.6024
74085593|NCT01077817|147725213|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.2|3.9|||Proportional hazards regression model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||3.9|0.2|
74085594|NCT01201486|147725269|SUPERIORITY_OR_OTHER||Percentage Sensitivity|23.0|||||TWO_SIDED||||||Percentage Sensitivity|||||||
74085595|NCT00108550|147725286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0305|STANDARD_ERROR_OF_MEAN|0.038||0.4237|TWO_SIDED|95.0|-0.044|0.105||There was no need for multiple comparisons adjustment for the primary outcome, since there was only one. However, secondary analyses were adjusted for multiple comparisons.|Mixed Models Analysis|Effect of covariates (age, gender, etc) was evaluated (modeled as fixed effects) in secondary analyses.|The analysis was performed on transformed (rather than raw) Descriptor Differential Score Pain Intensity scores.|The null hypothesis was that Gabapentin is no better than placebo in reducing back pain. A mean-matching variance stabilizing transformation was applied to Descriptor Differential Scale Pain intensity (DDS) scores. Scores were modeled as a function of time (week) and group (gabapentin, placebo) in a mixed effects model. Random (subject-specific)intercept and slopes were fitted to the data. With alpha = .05 and N = 65 per group power is .8 to detect effect size =.4 standard deviations (SD).||0.105|-0.044|0.4237
74085596|NCT00108550|147725287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5343|STANDARD_ERROR_OF_MEAN|0.7174||0.458|TWO_SIDED|95.0|-1.94|0.872||Primary analyses was multivariable linear regression with fixed and random effects. After the Bonferroni adjustment a p-value would have been considered significant at 0.05 level if \<0.01.|Mixed Models Analysis|||This is a secondary analysis; the null hypothesis is that Gabapentin performs no better than placebo in reducing the Roland and Morris score.||0.872|-1.940|0.458
74085597|NCT03604549|147725288|SUPERIORITY||Risk Ratio (RR)|0.44||||0.1|TWO_SIDED|95.0|0.16|1.25|||Chi-squared||Lipiodol UF is the numerator and Saline is the denominator for RR|||1.25|0.16|0.10
74085598|NCT03604549|147725289|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.96|TWO_SIDED|95.0|-1.59|1.68|||t-test, 2 sided||Difference reported as Lipiodol UF - Saline|||1.68|-1.59|0.96
74085599|NCT00436917|147725372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Kruskal-Wallis|||A sample of 60 participants was estimated to provide percentage statistics accuracy to within 13% with 95% confidence.||||0.01
74085600|NCT02438540|147725395|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085601|NCT02438540|147725396|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085602|NCT02438540|147725397|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085603|NCT02438540|147725398|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085604|NCT02438540|147725399|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|90.0|||||ANOVA|||||||0.04
74085605|NCT02438540|147725400|NON_INFERIORITY_OR_EQUIVALENCE|multiple comparatives||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
74085606|NCT02438540|147725400|NON_INFERIORITY_OR_EQUIVALENCE|from 0.60±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
74085607|NCT02438540|147725400|NON_INFERIORITY_OR_EQUIVALENCE|from 0.59±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
74085608|NCT02438540|147725401|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085609|NCT02438540|147725402|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085610|NCT02438540|147725403|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085611|NCT02438540|147725404|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085612|NCT02438540|147725405|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085613|NCT02438540|147725406|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085614|NCT02438540|147725407|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085615|NCT02438540|147725408|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085616|NCT02438540|147725409|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085617|NCT02438540|147725410|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085618|NCT02438540|147725411|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74085619|NCT02438540|147725412|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
74026807|NCT00077623|147607307|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.141|||<|0.0001|TWO_SIDED|97.5|-0.098|0.38||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)||0.380|-0.098|<0.0001
74085620|NCT05103657|147725421|OTHER||Mean Difference (Net)|0.06||||0.9726|TWO_SIDED|95.0|-3.31|3.43|||Mixed Models for repeated measures||"Least Squares mean of BI 1358894 125 mg - Least Square mean of Placebo."|Least Squares (LS) means differences and confidence intervals were estimated by REML-based MMRM including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.||3.43|-3.31|0.9726
73858852|NCT02752958|147263394|OTHER||Mean Difference (Final Values)|2.85|||<|0.0001|TWO_SIDED|95.0|1.477|4.222|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 24||4.222|1.477|<.0001
73858853|NCT02752958|147263395|OTHER||Mean Difference (Final Values)|0.09||||0.2326|TWO_SIDED|95.0|-0.059|0.243|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 4||0.243|-0.059|0.2326
73912871|NCT04613375|147355525|OTHER||Adjusted VE|25.96||||0.1827|TWO_SIDED|95.0|-15.21|52.42|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|||52.42|-15.21|0.1827
73912872|NCT04613375|147355526|OTHER||Adjusted VE|68.86||||0.028|TWO_SIDED|95.0|11.86|89.0|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\<2 years||89|11.86|0.028
73912873|NCT04613375|147355526|OTHER||Adjusted VE|7.97||||0.738|TWO_SIDED|95.0|-49.73|43.43|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|2 years to \<5 years||43.43|-49.73|0.738
73912874|NCT04613375|147355526|OTHER||Adjusted VE|30.06||||0.4327|TWO_SIDED|95.0|-70.86|71.37|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\>=5 years||71.37|-70.86|0.4327
73912875|NCT01081678|147355548|OTHER|||||||0.1983|||||||F-test|The p-value is based on F-test of multi-linear contrasts at Week 6 through Week 20.||The primary analysis was based on a test for linear trend in dose response at weeks 6, 12, 16, and 20. To account for multiple comparisons over time points, the primary analysis used a size α = 0.05 F-test with 4 degrees of freedom for the contrasts at Weeks 6, 12, 16, and 20.||||0.1983
73912876|NCT01517711|147355586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.286||||||P value is for overall post-randomization CAPS score|ANOVA|||Women were excluded from analysis because of the small sample size and unequal distribution across groups.||||0.286
73912877|NCT01517711|147355587|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.1|||||||ANOVA|||||||<0.10
73912878|NCT01517711|147355588|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.03|||||||ANOVA|||Analysis is for sleep only (men)||||=0.03
73912879|NCT02499783|147355593|SUPERIORITY||Adjusted Risk Difference|30.4|||<|0.001|TWO_SIDED|95.0|19.2|41.7|||Cochran-Mantel-Haenszel|Stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Risk difference = (adalimumab 160/80 mg - placebo). Stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|||41.7|19.2|<0.001
74085621|NCT05103657|147725422|OTHER||Odds Ratio (OR)|1.002||||0.9945|TWO_SIDED|95.0|0.608|1.65|||Regression, Logistic||BI 1358894 125 mg vs. Placebo|Logistic regression was adjusted for fixed factors of treatment and presence of significant childhood trauma (yes vs. no).||1.650|0.608|0.9945
73912880|NCT02499783|147355594|SUPERIORITY||Risk Difference Compared to 30%|34.6|||<|0.001|TWO_SIDED|95.0|26.2|42.4|||One Sample Exact Test|The one sample Exact test was performed by comparing it to the clinically meaningful remission rate of 30%.||||42.4|26.2|< 0.001
73912881|NCT02499783|147355595|SUPERIORITY||Adjusted Risk Difference|33.4|||<|0.001|TWO_SIDED|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||43.6|23.2|< 0.001
73912882|NCT02499783|147355599|SUPERIORITY||Adjusted Risk Difference|40.4|||<|0.001|TWO_SIDED|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||54.2|26.7|< 0.001
73912883|NCT02499783|147355600|SUPERIORITY||Adjusted Risk Difference|50.2|||<|0.001|TWO_SIDED|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||63.5|36.9|< 0.001
73965291|NCT03087708|147465844|OTHER||||||<|0.3116|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at Baseline||||<0.3116
73965292|NCT03087708|147465844|OTHER||||||<|0.7712|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at 6 Months||||<0.7712
73858854|NCT02752958|147263396|OTHER||Mean Difference (Final Values)|0.07||||0.3934|TWO_SIDED|95.0|-0.085|0.216||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||0.216|-0.085|0.3934
74026808|NCT00077623|147607307|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity .|Mean Difference between groups|-0.022|||<|0.0001|TWO_SIDED|97.5|-0.262|0.217||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)||0.217|-0.262|<0.0001
74026809|NCT00320671|147607399|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Analysis|Cumulative Response Rates|56.8||||0.61|TWO_SIDED|95.0|43.9|69.9|||Log Rank||Only the subjects taking risperidone were analysed in this section|||69.9|43.9|.61
74026810|NCT00320671|147607399|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Analysis|Cumulative Response Rates|62.8||||0.61|TWO_SIDED|95.0|50.8|74.8|||Log Rank||Only subjects taking aripiprazole were analysed in this section|||74.8|50.8|.61
74026811|NCT02951273|147607434|SUPERIORITY|||||||0.0276|||||||repeated measure mixed model|||||||0.0276
74026812|NCT02951273|147607435|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
74085622|NCT05103657|147725423|OTHER||Odds Ratio (OR)|0.912||||0.7167|TWO_SIDED|95.0|0.552|1.504|||Regression, Logistic||BI 1358894 125 mg vs. Placebo|Logistic regression was adjusted for fixed factors of treatment and presence of significant childhood trauma (yes vs. no).||1.504|0.552|0.7167
74085623|NCT05103657|147725424|OTHER||Mean Difference (Net)|0.66||||0.723|TWO_SIDED|95.0|-3.0|4.32|||Mixed Models for Repeated Measures||"Least Square mean of BI 1358894 125 mg - Least Square mean of Placebo."|Least Square (LS) means differences and confidence intervals were estimated by REML-based MMRM including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.||4.32|-3.00|0.7230
73858855|NCT02752958|147263397|OTHER||Mean Difference (Final Values)|0.13||||0.0795|TWO_SIDED|95.0|-0.016|0.284|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||0.284|-0.016|0.0795
73858856|NCT02752958|147263398|OTHER||Mean Difference (Final Values)|0.14||||0.0682|TWO_SIDED|95.0|-0.011|0.294|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16||0.294|-0.011|0.0682
73858857|NCT02752958|147263399|OTHER||Mean Difference (Final Values)|0.13||||0.0844|TWO_SIDED|95.0|-0.018|0.287|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20||0.287|-0.018|0.0844
73858858|NCT02752958|147263400|OTHER||Mean Difference (Final Values)|0.18||||0.0211|TWO_SIDED|95.0|0.027|0.332|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 24||0.332|0.027|0.0211
73858859|NCT02752958|147263401|OTHER||Mean Difference (Final Values)|0.6||||0.0493|TWO_SIDED|95.0|0.002|1.194|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4||1.194|0.002|0.0493
73858860|NCT02752958|147263402|OTHER||Mean Difference (Final Values)|1.42|||<|0.0001|TWO_SIDED|95.0|0.83|2.013|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||2.013|0.830|<0.0001
73858861|NCT02752958|147263403|OTHER||Mean Difference (Final Values)|1.87|||<|0.0001|TWO_SIDED|95.0|1.278|2.457||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||2.457|1.278|<0.0001
73858862|NCT02752958|147263404|OTHER||Mean Difference (Final Values)|2.03|||<|0.0001|TWO_SIDED|95.0|1.429|2.629|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16||2.629|1.429|<.0001
74026813|NCT02951273|147607436|SUPERIORITY|||||||0.6025|||||||Regression, Linear|||||||0.6025
74026814|NCT02951273|147607437|SUPERIORITY|||||||0.3213|||||||repeated measure mixed model|||||||0.3213
74026815|NCT02951273|147607438|SUPERIORITY|||||||0.0005||||||The reported p-value was calculated|repeated measure mixed model|||||||0.0005
74026816|NCT02951273|147607439|SUPERIORITY|||||||0.5404|||||||repeated measure mixed model|||||||0.5404
74026817|NCT02951273|147607440|SUPERIORITY|||||||0.8947|||||||repeated measure mixed model|||||||0.8947
74026818|NCT02951273|147607441|SUPERIORITY|||||||0.0068|||||||Linear mixed models|||||||0.0068
74026819|NCT02951273|147607442|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
74026820|NCT02951273|147607443|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74026821|NCT02951273|147607444|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
74026822|NCT02951273|147607445|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
74026823|NCT00121225|147607450|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
74026824|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.46|0.32|
74026825|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.41|0.30|
74085624|NCT04234464|147725430|SUPERIORITY||Mean Difference (Final Values)|13.51|||<|0.001|TWO_SIDED|95.0|10.09|16.94|||Mixed Models Analysis|||Maximum percentage fall in post-dose pre-exercise FEV₁ up to 60 minutes post-exercise challenge is analyzed using a mixed effects model adjusted for treatment, treatment period, treatment sequence as categorical fixed effects, period-specific pre-dose baseline FEV₁ and average pre-dose baseline FEV₁ as continuous covariates, and a random subject within treatment sequence effect.||16.94|10.09|<0.001
73858863|NCT02752958|147263405|OTHER||Mean Difference (Final Values)|2.34|||<|0.0001|TWO_SIDED|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||2.943|1.743|<.0001
74026826|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.61|0.44|
74026827|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
74026828|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.18|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.24|0.18|
74026829|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.41|0.31|
74085625|NCT04234464|147725431|SUPERIORITY||Odds Ratio (OR)|10.548|||<|0.001|TWO_SIDED|95.0|4.311|25.805|||Mixed Models Analysis|||A generalized linear mixed model with logit link adjusted for treatment, treatment period and treatment sequence as fixed effects, pre-dose baseline FEV₁ and average pre-dose baseline FEV₁ as continuous covariates, and a random subject within treatment sequence effect.||25.805|4.311|<0.001
74085626|NCT03635983|147725432|SUPERIORITY||Estimate of Odds Ratio (OR)|0.66||||0.0311|TWO_SIDED|95.0|0.45|0.96|||Stratified Cochran-Mantel-Haenszel|two-sided|Strata adjusted odds ratio (NKTR-214 + Nivolumab over Nivolumab) using Mantel-Haenszel method.|Bempegaldesleukin+Nivolumab over Nivolumab||0.96|0.45|0.0311
73965293|NCT03087708|147465844|OTHER||||||<|1|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at 6 Months||||<1.0
73965294|NCT03087708|147465845|OTHER||||||<|1|||||||Fisher Exact|||Analgesic Use at 6 Months||||<1.0000
73965295|NCT03087708|147465845|OTHER||||||<|0.5758|||||||Fisher Exact|||Analgesic Use at 6 Months||||<0.5758
74026830|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.32|0.19|
74026831|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
74026832|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.30|0.17|
74026833|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.25|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.39|0.25|
74026834|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.27|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.38|0.27|
73912884|NCT02499783|147355601|SUPERIORITY||Adjusted Risk Difference|27.6|||<|0.001|TWO_SIDED|95.0|18.2|37.0||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||37.0|18.2|< 0.001
73912885|NCT02499783|147355603|SUPERIORITY||Adjusted Risk Difference|19.6||||0.002|TWO_SIDED|95.0|7.1|32.1||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||32.1|7.1|0.002
73912886|NCT02499783|147355605|SUPERIORITY||Least Squares Mean Difference|-385.2|||<|0.001|TWO_SIDED|95.0|-598.81|-171.5||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||||-171.50|-598.81|< 0.001
73912887|NCT02499783|147355606|SUPERIORITY||Adjusted Risk Difference|9.8||||0.001|TWO_SIDED|95.0|3.9|15.8||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||15.8|3.9|0.001
73912888|NCT02499783|147355608|SUPERIORITY||Adjusted Risk Difference|18.4|||<|0.001|TWO_SIDED|95.0|8.2|28.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 2||28.6|8.2|< 0.001
73912889|NCT02499783|147355608|SUPERIORITY||Adjusted Risk Difference|30.4|||<|0.001|TWO_SIDED|95.0|19.2|41.7||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 4||41.7|19.2|< 0.001
73912890|NCT02499783|147355610|SUPERIORITY||Adjusted Risk Difference|21.4|||<|0.001|TWO_SIDED|95.0|12.6|30.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 2||30.2|12.6|< 0.001
73912891|NCT02499783|147355610|SUPERIORITY||Adjusted Risk Difference|33.4|||<|0.001|TWO_SIDED|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 4||43.6|23.2|< 0.001
73912892|NCT02499783|147355612|SUPERIORITY||Adjusted Risk Difference|21.7||||0.001|TWO_SIDED|95.0|8.7|34.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 2||34.6|8.7|0.001
73912893|NCT02499783|147355612|SUPERIORITY||Adjusted Risk Difference|40.4|||<|0.001|TWO_SIDED|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4||54.2|26.7|< 0.001
73912894|NCT02499783|147355614|SUPERIORITY||Adjusted Risk Difference|31.4|||<|0.001|TWO_SIDED|95.0|19.6|43.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 2||43.2|19.6|< 0.001
73912895|NCT02499783|147355614|SUPERIORITY||Adjusted Risk Difference|50.2|||<|0.001|TWO_SIDED|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4||63.5|36.9|< 0.001
73965296|NCT03087708|147465845|OTHER||||||<|1|||||||Fisher Exact|||Analgesic use at Baseline||||<1.0000
73965297|NCT03087708|147465845|OTHER|||||||0.593|||||||Fisher Exact|||Analgesic use at Baseline||||0.5930
73965298|NCT01303445|147465850|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.03||||||90.0|86.95|97.4||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||97.40|86.95|
73912896|NCT02499783|147355616|SUPERIORITY||Least Squares Mean Difference|-43.34|||<|0.001|TWO_SIDED|95.0|-59.39|-27.3||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 2||-27.30|-59.39|< 0.001
73912897|NCT02499783|147355616|SUPERIORITY||Least Squares Mean Difference|-66.63|||<|0.001|TWO_SIDED|95.0|-84.2|-49.06||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 4||-49.06|-84.20|< 0.001
73912898|NCT02499783|147355618|SUPERIORITY||Least Squares Mean Difference|-13.921|||<|0.001|TWO_SIDED|95.0|-19.183|-8.659||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 2||-8.659|-19.183|< 0.001
73912899|NCT02499783|147355618|SUPERIORITY||Least Squares Mean Difference|-16.844|||<|0.001|TWO_SIDED|95.0|-21.206|-12.483||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 4||-12.483|-21.206|< 0.001
73912900|NCT00555971|147355630|EQUIVALENCE|This was a statistical analysis to address the null hypothesis that there was no difference between treatment and placebo groups.||||||0.036|||||||Fisher Exact|||||||0.036
73912901|NCT00801632|147355644|SUPERIORITY_OR_OTHER||Percentage of Participants|60.0|||||TWO_SIDED|95.0|14.7|94.7|||||Clopper-Pearson used to derive confidence interval|||94.7|14.7|
73912902|NCT00801632|147355646|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED|||||P-value based on a paired t-test comparing baseline creatinine level with the level at study completion/participant termination.|t-test, 2 sided|The test describes whether the average of the difference is different from zero.||||||0.215
73912903|NCT00621582|147355652|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared|||comparing results of post-treatment global assessment by patient with that of pre-treatment||||0.01
73912904|NCT02021773|147355720|SUPERIORITY||Mean Difference (Final Values)|-22.74|STANDARD_ERROR_OF_MEAN|10.937||0.0386|TWO_SIDED|95.0|-44.28|-1.21||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.21|-44.28|0.0386
73912905|NCT02021773|147355720|SUPERIORITY||Mean Difference (Final Values)|-30.41|STANDARD_ERROR_OF_MEAN|10.9||0.0057|TWO_SIDED|95.0|-51.88|-8.95||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-8.95|-51.88|0.0057
73912906|NCT00668707|147355760|SUPERIORITY||Risk Ratio (RR)|1.01||||0.94|TWO_SIDED|95.0|0.83|1.22|||Regression, Logistic|||Analysis conducted was an adjusted logistic regression (adjuvant chemotherapy, adjuvant radiation, smoking history). Results were presented as a relative risk. Based on an estimated 30% outcome rate of recurrence or mortality in the control arm, 294 participants per arm provided 80% power to detect a relative risk of one third at an alpha of 0.05. We inflated this sample size to 346 per arm to account for 15% lost to follow-up.||1.22|0.83|0.94
73912907|NCT00668707|147355761|SUPERIORITY||Mean Difference (Net)|1.2||||0.36|TWO_SIDED|95.0|-1.3|3.7|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Analysis for the LC-13 scale.||3.7|-1.3|0.36
73912908|NCT00668707|147355761|SUPERIORITY||Mean Difference (Net)|0.4||||0.8|TWO_SIDED|95.0|-2.5|3.3||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Symptom Scale.||3.3|-2.5|0.80
73965299|NCT01303445|147465850|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.3||||||90.0|87.76|97.08||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||97.08|87.76|
73965300|NCT01303445|147465851|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|96.38||||||90.0|90.96|102.13||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||102.13|90.96|
73912909|NCT00668707|147355761|SUPERIORITY||Mean Difference (Net)|-0.7||||0.69|TWO_SIDED|95.0|-4.1|2.7||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Functional Scale.||2.7|-4.1|0.69
73912910|NCT00668707|147355761|SUPERIORITY||Mean Difference (Net)|-3.8||||0.11|TWO_SIDED|95.0|-8.5|0.9||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Global Scale.||0.9|-8.5|0.11
73912911|NCT00668707|147355762|SUPERIORITY||Mean Difference (Net)|-3.1||||0.13|TWO_SIDED|95.0|-7.2|0.9|||Mixed Models Analysis|||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||0.9|-7.2|0.13
73912912|NCT00668707|147355763|SUPERIORITY||Mean Difference (Net)|-4.1||||0.18|TWO_SIDED|95.0|-10.0|1.9|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Sleep Adequacy Analysis.||1.9|-10.0|0.18
73912913|NCT00668707|147355763|SUPERIORITY||Mean Difference (Net)|1.4||||0.41|TWO_SIDED|95.0|-2.0|4.8|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Sleep problems index II analysis.||4.8|-2.0|0.41
73965301|NCT01303445|147465851|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|97.03||||||95.0|93.26|100.95||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||100.95|93.26|
73965302|NCT01303445|147465852|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.32|99.72||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||99.72|98.32|
74026835|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.60|0.44|
74026836|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.20|0.10|
73858864|NCT02752958|147263406|OTHER||Mean Difference (Final Values)|2.34|||<|0.0001|TWO_SIDED|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.943|1.743|<.0001
73858865|NCT02752958|147263407|OTHER||Mean Difference (Final Values)|0.88|||<|0.0001|TWO_SIDED|95.0|0.474|1.295|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.295|0.474|<.0001
73858866|NCT02752958|147263408|OTHER||Mean Difference (Final Values)|1.28|||<|0.0001|TWO_SIDED|95.0|0.875|1.69|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||1.690|0.875|<.0001
73858867|NCT02752958|147263409|OTHER||Mean Difference (Final Values)|1.74|||<|0.0001|TWO_SIDED|95.0|1.333|2.145|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||2.145|1.333|<.0001
73858868|NCT02752958|147263410|OTHER||Mean Difference (Final Values)|1.96|||<|0.0001|TWO_SIDED|95.0|1.545|2.371|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||2.371|1.545|<.0001
73858869|NCT02752958|147263411|OTHER||Mean Difference (Final Values)|2.06|||<|0.0001|TWO_SIDED|95.0|1.643|2.469|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||2.469|1.643|<.0001
73858870|NCT02752958|147263412|OTHER||Mean Difference (Final Values)|2.21|||<|0.0001|TWO_SIDED|95.0|1.794|2.62||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.620|1.794|<.0001
73858871|NCT02752958|147263413|OTHER||Mean Difference (Final Values)|1.18|||<|0.0001|TWO_SIDED|95.0|0.703|1.66|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.660|0.703|<0.0001
73858872|NCT02752958|147263414|OTHER||Mean Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.977|1.926|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||1.926|0.977|<.0001
73858873|NCT02752958|147263415|OTHER||Mean Difference (Final Values)|1.95|||<|0.0001|TWO_SIDED|95.0|1.473|2.418|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 12||2.418|1.473|<.0001
73858874|NCT02752958|147263416|OTHER||Mean Difference (Final Values)|2.33|||<|0.0001|TWO_SIDED|95.0|1.848|2.81|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week16||2.810|1.848|<.0001
73858875|NCT02752958|147263417|OTHER||Mean Difference (Final Values)|2.21|||<|0.0001|TWO_SIDED|95.0|1.732|2.694|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||2.694|1.732|<.0001
73858876|NCT02752958|147263418|OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|2.02|2.982|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.982|2.020|<.0001
73912914|NCT00668707|147355767|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
73858877|NCT02752958|147263419|OTHER||Mean Difference (Final Values)|0.43||||0.0786|TWO_SIDED|95.0|-0.05|0.919|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4||0.919|-0.050|0.0786
73858878|NCT02752958|147263420|OTHER||Mean Difference (Final Values)|0.69||||0.005|TWO_SIDED|95.0|0.21|1.171|||ANOVA|\[1\] From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||1.171|0.210|0.0050
73858879|NCT02752958|147263421|OTHER||Mean Difference (Final Values)|1.4|||<|0.0001|TWO_SIDED|95.0|0.918|1.875|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 12||1.875|0.918|<.0001
73858880|NCT02752958|147263422|OTHER||Mean Difference (Final Values)|1.44|||<|0.0001|TWO_SIDED|95.0|0.951|1.926|||ANOVA|\[From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||1.926|0.951|<.0001
73858881|NCT02752958|147263423|OTHER||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.678|1.653||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20||1.653|0.678|<.0001
73858882|NCT02752958|147263424|OTHER||Mean Difference (Final Values)|1.56|||<|0.0001|TWO_SIDED|95.0|1.072|2.047|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||2.047|1.072|<.0001
73858883|NCT02182440|147263440|SUPERIORITY||Difference in LS means|-16.53|STANDARD_ERROR_OF_MEAN|19.243||0.949|TWO_SIDED|95.0|-62.57|29.5|||ANOVA|||Analysis for Part 1||29.50|-62.57|0.949
73858884|NCT02182440|147263440|SUPERIORITY||Difference in LS means|-4.65|STANDARD_ERROR_OF_MEAN|9.305||0.691|TWO_SIDED|95.0|-23.09|13.8|||ANOVA|||Analysis for Part 2||13.80|-23.09|0.691
73858885|NCT02182440|147263440|SUPERIORITY||Combined p-value|0.896||||0.896|TWO_SIDED||||||Inverse normal method||The p-values from Part 1 (see Statistical Analysis 1) and Part 2 (see Statistical Analysis 2) were combined to an overall p-value using the inverse normal method.|Combination of analysis results from Part 1 (see statistical Analysis 1) and Part 2 (see Statistical analysis 2)||||0.896
73912915|NCT00668707|147355768|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.41|TWO_SIDED|95.0|0.85|1.07|||Log Rank|||DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||1.07|0.85|0.41
73912916|NCT00668707|147355768|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.66|TWO_SIDED|95.0|0.85|1.11|||Log Rank|||This analysis included only those with stage I or II cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||1.11|0.85|0.66
73912917|NCT00668707|147355768|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.004|TWO_SIDED|95.0|0.61|0.92|||Log Rank|||This analysis included only those participants who had stage III or IV cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||0.92|0.61|0.004
73965303|NCT01303445|147465852|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|98.42||||||90.0|97.66|99.18||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||99.18|97.66|
73965304|NCT01303445|147465853|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|105.55||||||90.0|97.09|114.74||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||114.74|97.09|
73858886|NCT02182440|147263441|SUPERIORITY||Odds Ratio (OR)|1.4||||0.28|TWO_SIDED|95.0|0.8|2.4|||Chi-squared|||||2.4|0.8|0.28
73858887|NCT02182440|147263442|SUPERIORITY||Mean Difference (Net)|0.12||||0.02|TWO_SIDED|95.0|0.02|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.02|0.02
73858888|NCT02182440|147263443|SUPERIORITY||Mean Difference (Net)|0.12||||0.03|TWO_SIDED|95.0|0.01|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.01|0.03
73912918|NCT00668707|147355769|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.95|TWO_SIDED|95.0|-3.21|4.56|||Wilcoxon (Mann-Whitney)|||Analysis of melatonin changes||4.56|-3.21|0.95
73912919|NCT00668707|147355769|SUPERIORITY||Mean Difference (Final Values)|3.63||||0.02|TWO_SIDED|95.0|-0.15|7.42|||Wilcoxon (Mann-Whitney)|||Analysis of placebo changes||7.42|-0.15|0.02
73912920|NCT00668707|147355770|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
73912921|NCT00668707|147355771|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||This analysis compares the mean ratios of 6 month cytotoxicity and baseline cytotoxicity between arms.||||0.34
73912922|NCT00191139|147355776|SUPERIORITY_OR_OTHER||survival rate|40.6||||||95.0|23.8|56.8|||normal approximation|Count the number of surviving participants at each time interval to get survival rates.||||56.8|23.8|
73912923|NCT00191139|147355776|SUPERIORITY_OR_OTHER||survival rate|55.7||||||95.0|36.8|70.9|||normal approximation|Count the number of surviving participants at each time interval to get survival rates.||||70.9|36.8|
73912924|NCT00191139|147355777|SUPERIORITY_OR_OTHER||Response Rate|75.0||||||95.0|56.6|88.5|||normal approximation|||||88.5|56.6|
73912925|NCT00191139|147355777|SUPERIORITY_OR_OTHER||Response rate|84.4||||||95.0|67.2|94.7|||Normal approximation|||||94.7|67.2|
73912926|NCT00191139|147355778|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Log Rank|||||||0.08
73912927|NCT00191139|147355779|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Log Rank|||||||0.38
73912928|NCT02465515|147355781|NON_INFERIORITY|Non-inferiority was determined by testing the hypothesis that the observed hazard ratio is significantly different from the null margin of 1.3 (a one-sided p \<0.025 for such a test with result in appropriate direction being equivalent to the upper 95% confidence limit for the hazard ratio being less than 1.3)|Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.68|0.9||One-sided p-value based on Wald test of hazard ratio (HR) \>=1.3 versus HR \<1.3.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate|||0.90|0.68|<0.0001
73965305|NCT01303445|147465853|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|106.09||||||90.0|98.64|114.09||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||114.09|98.64|
73912929|NCT02465515|147355781|SUPERIORITY||||||<|0.001||||||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test|||||||<0.001
73912930|NCT02465515|147355782|OTHER||Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.69|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.90|0.69|<0.001
73912931|NCT02465515|147355783|OTHER||Hazard Ratio (HR)|0.93||||0.578|TWO_SIDED|95.0|0.73|1.19||Two-sided p-value based on the Wald statistic|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate|||1.19|0.73|0.578
73965306|NCT01303445|147465854|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.38||||||90.0|98.8|99.95||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||99.95|98.80|
74085627|NCT03635983|147725433|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3988||95.0|0.89|1.33||Log-rank stratified 2-sided. Boundary for statistical significance p-value \< 0.03|Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab|||1.33|0.89|0.3988
74085628|NCT03635983|147725434|SUPERIORITY|Bempegaldesleukin+Nivolumab over Nivolumab|Hazard Ratio (HR)|0.94||||0.6361|TWO_SIDED|95.0|0.72|1.22|||Log Rank|2-sided p-value. Boundary for statistical significance p-value \< 0.00071|Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab.|||1.22|0.72|0.6361
73965307|NCT01303445|147465854|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.46|99.59||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||99.59|98.46|
73965308|NCT03481660|147465856|NON_INFERIORITY|(4-letter margin) (1-sided)|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-0.6|3.1|||ANOVA|||BCVA at Week 52||3.1|-0.6|<0.001
73965309|NCT03481660|147465857|NON_INFERIORITY|(4-letter margin) (1-sided)|LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-0.9|2.6|||ANOVA|||BCVA over period Week 40 through Week 52||2.6|-0.9|<0.001
73965310|NCT03481660|147465857|SUPERIORITY|||||||0.164|||||||ANOVA|||BCVA over period Week 40 through Week 52||||0.164
73965311|NCT03481660|147465864|OTHER|Treatment Difference|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-0.6|3.1||||||BCVA at Week 52||3.1|-0.6|
73965312|NCT03481660|147465864|OTHER|Treatment Difference|LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.21|||TWO_SIDED|95.0|0.2|4.9||||||BCVA at Week 100||4.9|0.2|
74085629|NCT03635983|147725438|SUPERIORITY||Estimate of Odds Ratio (OR)|0.7||||0.0626|TWO_SIDED|95.0|0.48|1.02|||Stratified Cochran-Mantel-Haenszel|two-sided|Strata adjusted odds ratio (NKTR-214 + Nivolumab over Nivolumab) using Mantel-Haenszel method.|Bempegaldesleukin+Nivolumab over Nivolumab||1.02|0.48|0.0626
73912932|NCT02465515|147355784|OTHER||Hazard Ratio (HR)|0.75||||0.003|TWO_SIDED|95.0|0.61|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.90|0.61|0.003
73912933|NCT02465515|147355785|OTHER||Hazard Ratio (HR)|0.86||||0.3|TWO_SIDED|95.0|0.66|1.14||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.14|0.66|0.300
73912934|NCT02465515|147355786|OTHER||Hazard Ratio (HR)|0.85||||0.113|TWO_SIDED|95.0|0.7|1.04||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.04|0.70|0.113
73912935|NCT02465515|147355787|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.33|0.53||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.53|0.33|<0.001
73912936|NCT02465515|147355788|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.043|TWO_SIDED|95.0|0.51|0.99||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.99|0.51|0.043
73912937|NCT02465515|147355789|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 8||||||<0.001
73912938|NCT02465515|147355789|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 16||||||<0.001
73912939|NCT02465515|147355789|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 24||||||<0.001
73965313|NCT03481660|147465865|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-0.6|2.1||||||BCVA over period Week 4 through Week 52||2.1|-0.6|
73965314|NCT03481660|147465865|OTHER|Treatment difference|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.4|2.6||||||BCVA over period Week 4 through Week 100||2.6|-0.4|
73965315|NCT03481660|147465866|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-0.9|2.4||||||BCVA over period Week 20 through Week 52||2.4|-0.9|
74026837|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
74026838|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.09|0.16|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.16|0.09|
74026839|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.41|
74026840|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.43|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.43|
74026841|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.38|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.59|0.38|
74026842|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.6|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.00|0.60|
74026843|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.51|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.75|0.51|
74026844|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.86|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|0.86|
74026845|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.41|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.80|0.41|
74026846|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.73|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.73|0.39|
74085630|NCT03635983|147725439|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3713||95.0|0.9|1.33||Log-rank stratified 2-sided. Boundary for statistical significance p-value \< 0.03|Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab|||1.33|0.90|0.3713
74026847|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.78|1.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.67|0.78|
74026848|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.71|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.08|0.71|
74026849|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.54|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.75|0.54|
74085631|NCT03635983|147725443|SUPERIORITY||Odds Ratio (OR)|0.63||||||95.0|0.32|1.24|||||Logistic regression model with treatment, PD-L1 Status and treatment by PD-L1 Status interaction. Responders includes CR+PR|Bempegaldesleukin+Nivolumab vs. Nivolumab (PD-L1 Negative: \<1%)||1.24|0.32|
74085632|NCT03635983|147725443|SUPERIORITY||Odds Ratio (OR)|0.63||||0.9939|TWO_SIDED|95.0|0.39|1.02|||Stratified Cochran-Mantel-Haenszel|Interaction P-value|Logistic regression model with treatment, PD-L1 Status and treatment by PD-L1 Status interaction. Responders includes CR+PR|Bempegaldesleukin+Nivolumab vs. Nivolumab (PD-L1 Positive: \>=1%)||1.02|0.39|0.9939
74085633|NCT03635983|147725444|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.81|1.43|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 negative: \<1%)||1.43|0.81|
74085634|NCT03635983|147725444|SUPERIORITY||Hazard Ratio (HR)|1.12||||||95.0|0.83|1.51|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 positive: \>=1%)||1.51|0.83|
74085635|NCT03635983|147725445|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.66|1.4|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 negative: \<1%)||1.40|0.66|
73912940|NCT02465515|147355789|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Final assessment||||||<0.001
73912941|NCT02465515|147355790|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.055|TWO_SIDED|95.0|0.43|1.01||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.01|0.43|0.055
73912942|NCT02465515|147355791|OTHER||Mean Difference (Net)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.69|-0.58||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||-0.58|-0.69|<0.001
73912943|NCT02465515|147355791|OTHER||Mean Difference (Net)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.58|-0.45||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||-0.45|-0.58|<0.001
73912944|NCT02465515|147355792|OTHER||Mean Difference (Net)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.83|-0.49||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body Weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||-0.49|-0.83|<0.001
73912945|NCT02465515|147355792|OTHER||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.06|-0.6||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||-0.60|-1.06|<0.001
73912946|NCT02465515|147355793|OTHER||Mean Difference (Net)|2.39|||<|0.001|TWO_SIDED|95.0|1.85|2.93||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||2.93|1.85|<0.001
73912947|NCT02465515|147355793|OTHER||Mean Difference (Net)|2.33|||<|0.001|TWO_SIDED|95.0|1.66|3.01||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||3.01|1.66|<0.001
73912948|NCT02465515|147355794|OTHER||Mean Difference (Net)|1.47|||<|0.001|TWO_SIDED|95.0|0.87|2.07||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.|||2.07|0.87|<0.001
73965316|NCT03481660|147465866|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-0.9|2.5||||||BCVA over period Week 28 through Week 52||2.5|-0.9|
73912949|NCT02465515|147355794|OTHER||Mean Difference (Net)|0.52||||0.192|TWO_SIDED|95.0|-0.26|1.31||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide - Placebo) is from MMRM model for Month 16|||1.31|-0.26|0.192
73912950|NCT02465515|147355795|OTHER||Hazard Ratio (HR)|0.95||||0.644|TWO_SIDED|95.0|0.79|1.16||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.16|0.79|0.644
73912951|NCT02465515|147355799|OTHER||Mean Difference (Net)|-1.11||||0.003|TWO_SIDED|95.0|-1.84|-0.39||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.|||-0.39|-1.84|0.003
73912952|NCT02465515|147355799|OTHER||Mean Difference (Net)|-0.43||||0.315|TWO_SIDED|95.0|-1.26|0.41||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16.|||0.41|-1.26|0.315
73912953|NCT03846804|147355804|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
73912954|NCT00345839|147355830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.112||||||p-value\<0.044 considered significant|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.112
73912955|NCT00345839|147355830|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.85|1.02|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.02|0.85|
73912956|NCT00345839|147355831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.249||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.249
73965317|NCT03481660|147465866|OTHER|Treatment difference|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-0.5|2.9||||||BCVA over period Week 20 through Week 100||2.9|-0.5|
73965318|NCT03481660|147465866|OTHER|Treatment difference|LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|95.0|-0.5|3.0||||||BCVA over period Week 28 through Week 100||3.0|-0.5|
73965319|NCT03481660|147465867|OTHER|Treatment difference|LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-0.1|4.3||||||BCVA over period Week 88 through Week 100||4.3|-0.1|
73912957|NCT00345839|147355831|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.85|1.04|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.04|0.85|
73912958|NCT00345839|147355832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.800
73912959|NCT00345839|147355832|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.19|0.79|
73912960|NCT00345839|147355833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.283
73912961|NCT00345839|147355833|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.58|1.18|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.18|0.58|
73912962|NCT00345839|147355834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.034
74085636|NCT03635983|147725445|SUPERIORITY||Hazard Ratio (HR)|0.88||||||95.0|0.58|1.33|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 positive: \>=1%)||1.33|0.58|
73912963|NCT00345839|147355834|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.68|0.99|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||0.99|0.68|
73912964|NCT00345839|147355835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.190
73912965|NCT00345839|147355835|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.72|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.72|
73912966|NCT00345839|147355836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.277
73912967|NCT00345839|147355836|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.8|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.80|
73912968|NCT00345839|147355837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.607||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.607
73912969|NCT00345839|147355837|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.82|1.4|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.40|0.82|
73912970|NCT00345839|147355838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.218
73912971|NCT00345839|147355838|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.75|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.75|
73912972|NCT00345839|147355839|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||<0.001
73912973|NCT00345839|147355839|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.36|0.54|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||0.54|0.36|
73912974|NCT05544734|147355840|SUPERIORITY||Median Difference (Final Values)|-0.3||||0.69|TWO_SIDED|95.0|-1.85|1.25|||t-test, 2 sided||Direction = Hydrocodone group mean change (i.e., change = baseline to postoperative day 2) minus Non-Hydrocodone group mean change (i.e., change = baseline to postoperative day 2).|||1.25|-1.85|0.69
73912975|NCT05544734|147355841|SUPERIORITY||Median Difference (Final Values)|2.3||||0.62|TWO_SIDED|95.0|-7.25|11.85|||t-test, 2 sided||Direction = Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6) minus Non-Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6).|||11.85|-7.25|0.62
73912976|NCT01218113|147355855|NON_INFERIORITY|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D\_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|0.801|||||TWO_SIDED|97.5|0.553|1.162|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 3 doses of the HIV vaccine 732462 and persons who received placebo alone.||1.162|0.553|
73965320|NCT03481660|147465868|OTHER|Treatment difference|Clopper-Pearson exact method|0.4|||||TWO_SIDED|95.0|-7.6|8.9||||||Gain of \>= 5 letters in BCVA at Week 52||8.9|-7.6|
74085637|NCT01235442|147725510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.001|TWO_SIDED|95.0|1.46|2.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI(=\<35 or \>35) and prior anti-TNF exposure(Yes or no).||||2.87|1.46|<0.001
74085638|NCT01235442|147725511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.4|2.75||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||2.75|1.40|<0.001
74085639|NCT01235442|147725512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.009|TWO_SIDED|95.0|1.21|2.64||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||2.64|1.21|0.009
74085640|NCT01235442|147725513|SUPERIORITY_OR_OTHER|||||||0.006||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No) with with modified ridit scores.||||||0.006
74085641|NCT01235442|147725514|SUPERIORITY_OR_OTHER||||||<|0.001||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|van Elteren test|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||||<0.001
73912977|NCT01218113|147355855|NON_INFERIORITY|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D\_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|1.184|||||TWO_SIDED|97.5|0.816|1.717|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.||1.717|0.816|
74085642|NCT01235442|147725515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.135|TWO_SIDED|95.0|0.92|1.85||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is adjusted for baseline BMI (=\<35 or \>35) and prior anti-TNF (Yes or No).||||1.85|0.92|0.135
74085643|NCT01235442|147725516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.135|TWO_SIDED|95.0|0.96|1.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||1.87|0.96|0.135
74085644|NCT03712124|147725517|OTHER||Least Square (LS) Mean Difference|-6.44||||0.903|TWO_SIDED|95.0|-116.18|103.31|||ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) model with change from baseline at Day 14 as the dependent variable and baseline maximum tolerated volume and treatment as covariates.||103.31|-116.18|0.9030
74085645|NCT03712124|147725518|OTHER||LS Mean Difference|98.45||||0.0042|TWO_SIDED|95.0|35.81|161.08|||ANCOVA|||Analysis was performed using ANCOVA model with change from baseline at Day 28 as the dependent variable and baseline maximum tolerated volume and treatment as covariates.||161.08|35.81|0.0042
74085646|NCT00373425|147725550|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.3235|TWO_SIDED|95.0|0.741|1.104||If the primary analysis of DFS was not statistically significant, the hierarchical testing procedure would stop and all key secondary efficacy analyses would be nonsignificant; any further analysis of these outcomes would be considered exploratory.|Log Rank||Hazard ratio: erlotinib to placebo|The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level. The primary analysis of DFS was performed when at least 410 events had accrued. If the result of the primary analysis of DFS was statistically significant favoring the erlotinib treatment arm, the null hypothesis of no treatment difference of key secondary efficacy variables was tested under a hierarchical testing procedure.||1.104|0.741|0.3235
74085647|NCT00373425|147725555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.562|TWO_SIDED|95.0|0.78|1.144|||Log Rank|||The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level.||1.144|0.780|0.5620
74085648|NCT00551616|147725573|OTHER||% of observed pregnancies|1.78|||<|0.001|TWO_SIDED|95.0|1.04|2.98|||Chi-squared||Expected pregnancy rate = 5.58%|Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998||2.98|1.04|<0.001
74085649|NCT00551616|147725573|OTHER||% of observed pregnancies|2.59|||<|0.001|TWO_SIDED|95.0|1.68|3.94|||Chi-squared||Expected pregnancy rate = 5.43%|Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998||3.94|1.68|<0.001
74085650|NCT01976728|147725585|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.012||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||The primary efficacy analysis compared the pooled ovulation rate of the LutrePulse 15 μg and 20 μg group to placebo.||||0.0120
74085651|NCT01976728|147725586|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0553||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||P4 levels of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0553
73965321|NCT03481660|147465868|OTHER|Treatment difference|Clopper-Pearson exact method|5.4|||||TWO_SIDED|95.0|-3.9|14.5||||||Gain of \>= 5 letters in BCVA at Week 100||14.5|-3.9|
73965322|NCT03481660|147465869|OTHER|Treatment difference|Clopper-Pearson exact method|5.4|||||TWO_SIDED|95.0|-3.9|14.7||||||Gain of \>= 10 letters in BCVA at Week 52||14.7|-3.9|
73965323|NCT03481660|147465869|OTHER|Treatment difference|Clopper-Pearson exact method|9.9|||||TWO_SIDED|95.0|-0.4|19.4||||||Gain of \>= 10 letters in BCVA at Week 100||19.4|-0.4|
73965324|NCT03481660|147465870|OTHER|Treatment difference|Clopper-Pearson exact method|9.6|||||TWO_SIDED|95.0|-0.4|20.2||||||Gain of \>= 15 letters in BCVA at Week 52||20.2|-0.4|
73965325|NCT03481660|147465870|OTHER|Treatment difference|Clopper-Pearson exact method|13.6|||||TWO_SIDED|95.0|3.3|23.5||||||Gain of \>= 15 letters in BCVA at Week 100||23.5|3.3|
73965326|NCT03481660|147465871|OTHER|Treatment difference|Clopper-Pearson exact method|-0.4|||||TWO_SIDED|95.0|-4.2|2.9||||||Loss of \>= 5 letters in BCVA at Week 52||2.9|-4.2|
73965327|NCT03481660|147465871|OTHER|Treatment difference|Clopper-Pearson exact method|-6.0|||||TWO_SIDED|95.0|-10.8|-1.7||||||Loss of \>= 5 letters in BCVA at Week 100||-1.7|-10.8|
74026850|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.78|1.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.06|0.78|
74026851|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.51|0.29|
74026852|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.56|0.39|
74026853|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.53|
74026854|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.49|
74026855|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.52|0.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.63|0.52|
73858889|NCT02182440|147263444|SUPERIORITY||Hazard Ratio (HR)|1.77||||0.045|TWO_SIDED|95.0|1.0|3.1|||Regression, Logistic|||||3.1|1.0|0.045
73858890|NCT02182440|147263445|SUPERIORITY||Hazard Ratio (HR)|1.85||||0.03|TWO_SIDED|95.0|1.06|3.26|||Regression, Logistic|||||3.26|1.06|0.03
73858891|NCT00072293|147263446|NON_INFERIORITY_OR_EQUIVALENCE|As originally designed, target accrual was 1960 patients with analysis planned after 558 events. These targets were based on having 90% power to detect non-inferiority of no axillary dissection with a one-sided statistical signifi cance level of 10% (ie, α=0·10) under the assumption that 5-year disease-free survival with axillary dissection was 70% and defining non-inferiority as a hazard ratio (HR) of less than 1·25 (no axillary dissection relative to axillary dissection).|Hazard Ratio (HR)|0.78||||0.004|TWO_SIDED|95.0|0.55|1.11||Test for non-inferiority of no axillary dissection. Stratified logrank test compared groups. HR (no-AD vs AD) estimated from test statistic and variance as HR=exp(\[O-E\]/V), compared to 1.25 in 1-sided test of non-inferiority.|1-sided non-inferiority test||Hazard Ratio is no axillary dissection/axillary dissection.|||1.11|0.55|0.004
73858892|NCT00072293|147263447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.73|TWO_SIDED|90.0|0.52|1.54|||Log Rank||Hazard Ratio is no axillary dissection/axillary dissection.|||1.54|0.52|0.73
73858893|NCT00901511|147263465|SUPERIORITY||Median Difference (Final Values)|12.0||||0.0078|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the median time to rescue WLL in the GM-CSF Group minus the median the time to rescue WLL in the Control Group|||||0.0078
73858894|NCT00901511|147263466|SUPERIORITY||Risk Ratio (RR)|7.0||||0.0152|TWO_SIDED|95.0|1.6|39.9|||Fisher Exact||Calculated as risk ratio of rescue WLL in the Control Group compared to the risk ratio of rescue WLL in the GM-CSF Group|||39.9|1.60|0.0152
73858895|NCT00901511|147263467|SUPERIORITY||Mean Difference (Final Values)|9.5|||<|0.0001|TWO_SIDED|95.0|5.7|13.3|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean PaO2 in the GM-CSF Group minus the between group difference in mean PaO2 in the Control Group|||13.3|5.7|<0.0001
73858896|NCT00901511|147263467|SUPERIORITY||Mean Difference (Final Values)|15.1|STANDARD_ERROR_OF_MEAN|6.16||0.0261|TWO_SIDED|95.0|2.04|28.16|||t-test, 2 sided||Calculated as the difference at the pre-WLL visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the pre-WLL visit after imputation of missing data using a last observation carried forward method.||28.16|2.04|0.0261
73858897|NCT00901511|147263467|SUPERIORITY||Mean Difference (Final Values)|9.56|STANDARD_ERROR_OF_MEAN|6.36||0.1521|TWO_SIDED|95.0|3.92|23.03|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||23.03|3.92|0.1521
73858898|NCT00901511|147263467|SUPERIORITY||Mean Difference (Final Values)|18.04|STANDARD_ERROR_OF_MEAN|5.56||0.0051|TWO_SIDED|95.0|6.26|29.82|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||29.82|6.26|0.0051
73858899|NCT00901511|147263467|SUPERIORITY||Mean Difference (Final Values)|20.26|STANDARD_ERROR_OF_MEAN|4.54||0.0004|TWO_SIDED|95.0|10.63|29.88|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||29.88|10.63|0.0004
73858900|NCT00901511|147263467|SUPERIORITY||Mean Difference (Final Values)|19.91|STANDARD_ERROR_OF_MEAN|5.89||0.0038|TWO_SIDED|95.0|7.43|32.4|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||32.40|7.43|0.0038
73912978|NCT01218113|147355856|NON_INFERIORITY|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D\_HIV Group - Control Group) is below 0.|Mean Difference|-0.096|||||TWO_SIDED|97.5|-0.257|0.065|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 3 doses of the HIV Vaccine 732462 and persons who received placebo alone.||0.065|-0.257|
73912979|NCT01218113|147355856|NON_INFERIORITY|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D\_HIV Group - Control Group) is below 0.|Mean Difference|0.073|||||TWO_SIDED|97.5|-0.088|0.235|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.||0.235|-0.088|
74085652|NCT01976728|147725587|SUPERIORITY|The hypotheses was tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0383||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||Clinical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0383
73912980|NCT00967668|147355915|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Linear|Linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables||All participants were included in outcomes analyses using intention-to-treat principles. A linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables was used.This statistical approach allows the use of data from all participants as long as the dependent variable is available for at least one time point. Each subject was included as a random intercept to adjust for within-person correlations.||||<0.05
73912981|NCT01258582|147355935|SUPERIORITY_OR_OTHER||difference in the acceptance rates|-0.022||||0.34|TWO_SIDED|95.0|-0.067|0.023|||Chi-squared|The difference in the acceptance rates was estimated along with 95% confidence intervals and tested using the chi-square test.||Sample size was chosen to detect a 10% difference in acceptance rates between two testing modality arms (90% power, 0.05 level of significance).||0.023|-0.067|0.34
73858901|NCT00901511|147263467|SUPERIORITY||Mean Difference (Final Values)|16.92|STANDARD_ERROR_OF_MEAN|6.15||0.0149|TWO_SIDED|95.0|3.81|30.03|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||30.03|3.81|0.0149
73858902|NCT00901511|147263467|SUPERIORITY||Mean Difference (Final Values)|19.02|STANDARD_ERROR_OF_MEAN|6.97||0.0148|TWO_SIDED|95.0|4.26|33.79|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||33.79|4.26|0.0148
73912982|NCT02957305|147355936|NON_INFERIORITY|400µg of misoprostol yields a 96% cervical dilation \> 8 mm. We considered 86% of the 200 µg misoprostol group as the minimal acceptable percentage. The non-inferiority margin was determined by 24.46.|treatment difference|25.0||||0.025|ONE_SIDED|95.0||97.5||The null hypothesis: percentage of dilation with 400µg ≥ percentage of dilation with 200µg + 25% Alternative hypothesis: percentage of dilation with 400µg - 25% \< percentage of dilation with 200µg|difference between proportions|difference between percentages and 95% confidence interval||If there is a true difference in favour of the standard treatment of 10% (96% vs 86%), then 184 patients are required to be 95% sure that the upper limit of a one-sided 97.5% confidence interval (or equivalently a 95% two-sided confidence interval) will exclude a difference in favour of the standard group of more than 25%||97.5||0.025
73912983|NCT02957305|147355936|NON_INFERIORITY|The non-inferiority margin was determined by ⅓ of the difference between the 400µg effect (96.7%), compared to the 200 µg dose (23.3%), i.e. 73.4 / 3 = 24.46%|Difference between proportions|0.1146||||0.004|TWO_SIDED|95.0|0.037|0.192|||Chi-squared||The difference between both groups was 11.5% (95%CI = 3.7% to 19.2%)|||0.192|0.037|0.004
73912984|NCT02957305|147355938|SUPERIORITY||Median Difference (Final Values)|0.0||||0.9|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.9
73912985|NCT02417831|147355993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|105.76|STANDARD_DEVIATION|14.18|||TWO_SIDED|90.0|99.81|112.08|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||112.08|99.81|
73912986|NCT02417831|147355994|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|101.4|STANDARD_DEVIATION|9.05|||TWO_SIDED|90.0|97.71|105.23|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||105.23|97.71|
73912987|NCT02417831|147355995|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|101.42|STANDARD_DEVIATION|8.85|||TWO_SIDED|90.0|97.81|105.17|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||105.17|97.81|
73912988|NCT01803204|147356035|SUPERIORITY_OR_OTHER||GEE|1.0||||1|TWO_SIDED|99.0|||||GEE|||||||1.00
73912989|NCT01803204|147356036|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|99.0|||||Mist Effects Model|||||||<0.01
73858903|NCT00901511|147263467|SUPERIORITY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|6.62||0.1158|TWO_SIDED|95.0|-3.02|25.02|||t-test, 2 sided|||The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.|Calculated as the difference at the 30-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|25.02|-3.02|0.1158
73912990|NCT01803204|147356037|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|99.0|||||Mist Effect Model|||||||0.81
73912991|NCT01867424|147356065|OTHER||Median of Differences|0.43||||0.0008|TWO_SIDED|||||Median of difference in CER: All cases.|Wilcoxon Test||The relative difference between groups is based on the change from baseline values to the values collected at each of the three time points.|Null Hypothesis: There is no significant difference in contrast enhancement ratio (CER) in prostate cancers upon injection of Eovist. Subgroup analysis of CER in (i) Advanced Disease and (ii) Localized Disease||||0.0008
73965328|NCT03481660|147465872|OTHER|Treatment difference|Clopper-Pearson exact method|-0.2|||||TWO_SIDED|95.0|-3.2|2.4||||||Loss of \>= 10 letters in BCVA at Week 52||2.4|-3.2|
73912992|NCT01867424|147356065|OTHER||Median of Differences|0.42||||0.0039|TWO_SIDED|||||Median of difference in CER: Advanced Disease Cases.|Wilcoxon Test|||||||0.0039
73912993|NCT01867424|147356065|OTHER||Median of Differences|0.475||||0.084|TWO_SIDED|||||Median of difference in CER: Local Disease Cases.|Wilcoxon Test|||||||0.084
73912994|NCT01867424|147356065|OTHER||Median Difference CER|0.17||||0.25|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection.||||0.25
73912995|NCT01867424|147356065|OTHER||Median Difference CER|0.27||||0.1602|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection.||||0.1602
73912996|NCT01867424|147356065|OTHER||Median Difference CER|0.29||||0.0078|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection.||||0.0078
73912997|NCT01867424|147356065|OTHER||Median Difference CER|0.34||||0.0039|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection.||||0.0039
73912998|NCT01867424|147356065|OTHER||Median Difference CER|0.27||||0.0046|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection; Total cases.||||0.0046
73912999|NCT01867424|147356065|OTHER||Median Difference CER|0.33||||0.0017|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection; Total cases.||||0.0017
73913000|NCT01867424|147356067|OTHER||Spearman r|-0.137||||0.5761|TWO_SIDED|95.0|-0.5665|0.3511|||Nonparametric Spearman correlation|The calculation of Spearman correlation is between baseline PSA and CER at 20 minutes post Eovist injection.||Null Hypothesis: There is no significant difference in contrast enhancement ratio (CER) with Eovist injection based on baseline Prostate-specific antigen (PSA) levels at 20-minute timepoint.||0.3511|-0.5665|0.5761
73913001|NCT01867424|147356067|OTHER||Spearman r|-0.257||||0.3033|TWO_SIDED|95.0|-0.6549|0.2526|||nonparametric Spearman correlation|||Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 40 minutes post Eovist injection.||0.2526|-0.6549|0.3033
73913002|NCT01867424|147356067|OTHER||Spearman r|-0.2861||||0.2351|TWO_SIDED|95.0|-0.6634|0.2071|||nonparametric Spearman correlation|||Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 60 minutes post Eovist injection.||0.2071|-0.6634|0.2351
73913003|NCT01867424|147356067|OTHER||Median Difference (actual)|-0.47||||0.111|TWO_SIDED||||||Mann Whitney|||Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA \< or \>/= 20ng/ml.||||0.111
73913004|NCT01867424|147356067|OTHER||Median Difference (actual)|-0.775||||0.7738|TWO_SIDED||||||Mann Whitney|||Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA \< or \>/= 20ng/ml.||||0.7738
73913005|NCT01056653|147356069|SUPERIORITY_OR_OTHER||||||=|0.03|||||||ANCOVA|F(2,107)=3.48, partial n2=0.061, observed power=0.639||ANCOVA - Group Comparison of Parent Total Score on PCITS at 8 months, controlling for scores at baseline (4 months). Group entered as as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||=0.03
73913006|NCT01056653|147356069|SUPERIORITY_OR_OTHER|||||||0.03||||||Bonferroni adjustments for multiple comparisons used|ANOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores||||0.03
73913007|NCT01056653|147356069|SUPERIORITY_OR_OTHER|||||||0.534||||||Bonferroni adjustment for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores||||0.534
73913008|NCT01056653|147356069|SUPERIORITY_OR_OTHER|||||||0.047|||||||ANCOVA|F(2,107)=3.145, partial n2=0.056, observed power=0.593.||ANCOVA - Group Comparison of Cognitive Growth Fostering Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.047
73913009|NCT01056653|147356069|SUPERIORITY_OR_OTHER|||||||0.056||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale||||0.056
73913010|NCT01056653|147356069|SUPERIORITY_OR_OTHER|||||||0.267||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale||||0.267
73913011|NCT01056653|147356069|SUPERIORITY_OR_OTHER|||||||0.036|||||||ANCOVA|F(2,107)=3.440, partial n2=0.060, observed power=0.634||ANCOVA - Group Comparison of Socio-Emotional Growth Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.036
73913012|NCT01056653|147356069|SUPERIORITY_OR_OTHER|||||||0.036||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale||||0.036
73913013|NCT01056653|147356069|SUPERIORITY_OR_OTHER|||||||1||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale||||1.00
73965329|NCT03481660|147465872|OTHER|Treatment difference|Clopper-Pearson exact method|-4.1|||||TWO_SIDED|95.0|-8.4|-0.1||||||Loss of \>= 10 letters in BCVA at Week 100||-0.1|-8.4|
73965330|NCT03481660|147465873|OTHER|Treatment difference|Clopper-Pearson exact method|-0.7|||||TWO_SIDED|95.0|-3.2|1.6||||||Loss of \>= 15 letters in BCVA at Week 52||1.6|-3.2|
73913014|NCT01056653|147356069|SUPERIORITY_OR_OTHER|||||||0.665|||||||ANCOVA|F(2,107)=0.409||ANCOVA - Group Comparison of Sensitivity to Cues Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.665
73913015|NCT01056653|147356069|SUPERIORITY_OR_OTHER|||||||0.732|||||||ANCOVA|F(2,107)=0.313||ANCOVA - Group Comparison of Response to Distress Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.732
73913016|NCT01056653|147356070|SUPERIORITY_OR_OTHER|||||||0.61|||||||ANCOVA|F(2,107)=0.49||ANCOVA - Group Comparison of Parent Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.61
73913017|NCT01056653|147356070|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANCOVA|F(2,107)=0.96||ANCOVA - Group Comparison of Child Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.38
73913018|NCT01056653|147356071|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANCOVA|F(2,106)=2.24.||ANCOVA - Group Comparison of WPL-R scores - Evaluation Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.11
73913019|NCT01056653|147356071|SUPERIORITY_OR_OTHER|||||||0.686|||||||ANCOVA|F(2,106)=0.379||ANCOVA - Group Comparison of WPL-R scores - Centrality Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.686
73913020|NCT01056653|147356071|SUPERIORITY_OR_OTHER|||||||0.121|||||||ANCOVA|F(2,106)=2.158||ANCOVA - Group Comparison of WPL-R scores - Life Change Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.121
73913021|NCT01751178|147356072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.061|||<|0.0001|TWO_SIDED|95.0|-0.081|-0.041||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two groups.||-0.041|-0.081|<0.0001
73913022|NCT01751178|147356072|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|||<|0.0001|TWO_SIDED|95.0|-0.09|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.||-0.050|-0.090|<0.0001
73913023|NCT01751178|147356073|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.1|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis that there was no difference between the two treatment groups.||-0.05|-0.10|<0.0001
73913024|NCT01751178|147356073|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.11|-0.06||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.||-0.06|-0.11|<0.0001
73913025|NCT01751178|147356074|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.98|-0.62||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque scores.||-0.62|-0.98|<0.0001
73913026|NCT01751178|147356074|SUPERIORITY_OR_OTHER||Adusted Mean Difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.04|-0.68||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque Scores.||-0.68|-1.04|<0.0001
73913027|NCT01751178|147356075|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.69||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two treatments.||-0.69|-1.07|<0.0001
73913028|NCT01751178|147356075|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.78||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two groups.||-0.78|-1.16|<0.0001
74026856|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.66|0.53|
74026857|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.64|0.42|
73913029|NCT00332163|147356082|SUPERIORITY_OR_OTHER||Difference|-33.0|||||TWO_SIDED|95.0|-51.0|-14.0|||||Difference = Pre-emptive - Reactive|||-14|-51|
73913030|NCT00332163|147356083|SUPERIORITY_OR_OTHER||Difference|-22.0|||||TWO_SIDED|95.0|-42.0|-3.0|||||Difference = Pre-emptive - Reactive|||-3|-42|
73913031|NCT00332163|147356084|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (pre-emptive vs. reactive), stratified by chemotherapy stratum (Q2W vs Q3W).|||0.7|0.2|
73913032|NCT00332163|147356086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||0.7|0.2|
73913033|NCT00332163|147356087|SUPERIORITY_OR_OTHER||Difference|-4.0|||||TWO_SIDED|95.0|-16.0|7.0|||||Difference = Pre-emptive - Reactive|||7|-16|
73913034|NCT00332163|147356088|SUPERIORITY_OR_OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.0|10.0|||||Difference = Pre-emptive - Reactive|||10|-10|
73913035|NCT00332163|147356089|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|95.0|-9.0|17.0|||||Rate difference = Pre-emptive - Reactive|||17|-9|
73913036|NCT00332163|147356090|SUPERIORITY_OR_OTHER||Difference|-1.0|||||TWO_SIDED|95.0|-21.0|18.0|||||Rate difference = Pre-emptive - Reactive|||18|-21|
73913037|NCT00332163|147356091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||2.0|0.9|
73913038|NCT00332163|147356092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.6|1.5|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||1.5|0.6|
73913039|NCT00332163|147356093|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|2.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||2.1|0.7|
73913040|NCT00332163|147356094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.6|||||Hazard ratio is estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||1.6|0.6|
73913041|NCT02621060|147356096|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|2.0||0.004|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
73913042|NCT02621060|147356097|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
73913043|NCT02621060|147356098|SUPERIORITY_OR_OTHER|||||||0.755|||||||Wilcoxon (Mann-Whitney)|||||||0.755
73913044|NCT02621060|147356099|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73913045|NCT02621060|147356100|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
73913046|NCT02621060|147356101|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73913047|NCT02621060|147356103|SUPERIORITY_OR_OTHER|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
73913048|NCT02621060|147356104|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
73913049|NCT02621060|147356105|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.022|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.022
73913050|NCT02621060|147356106|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.022|TWO_SIDED|5.0|||||Wilcoxon (Mann-Whitney)|||||||0.022
73913051|NCT02621060|147356107|SUPERIORITY_OR_OTHER|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
73913052|NCT02621060|147356108|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
73913053|NCT02621060|147356109|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73913054|NCT02621060|147356110|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73913055|NCT02621060|147356111|SUPERIORITY_OR_OTHER|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||||||0.059
73913056|NCT02621060|147356112|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
73913057|NCT02621060|147356113|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73913058|NCT02621060|147356114|SUPERIORITY_OR_OTHER|||||||0.376|||||||Wilcoxon (Mann-Whitney)|||||||0.376
73913059|NCT02621060|147356115|SUPERIORITY_OR_OTHER|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||||||0.472
73913060|NCT02621060|147356116|SUPERIORITY_OR_OTHER|||||||0.774|||||||Wilcoxon (Mann-Whitney)|||||||0.774
73913061|NCT02621060|147356117|SUPERIORITY_OR_OTHER|||||||0.637|||||||Wilcoxon (Mann-Whitney)|||||||0.637
73913062|NCT03733470|147356118|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73913063|NCT01010061|147356119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.16|0.28||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.28|0.16|<0.0001
73913064|NCT01010061|147356121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.14|0.27|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.27|0.14|<0.0001
73913065|NCT01010061|147356124|SUPERIORITY||Difference in Response Rates|45.1|||<|0.0001|TWO_SIDED|95.0|34.7|55.5|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.||55.5|34.7|< 0.0001
73913066|NCT01010061|147356125|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.15|0.26|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.26|0.15|<0.0001
73913067|NCT01010061|147356126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0196|TWO_SIDED|95.0|0.49|0.94|||Log Rank, Stratified|||||0.94|0.49|0.0196
73913068|NCT01010061|147356127|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.28|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.28|0.13|<0.0001
73913069|NCT01010061|147356129|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.35|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.35|0.19|<0.0001
73965331|NCT03481660|147465873|OTHER|Treatment difference|Clopper-Pearson exact method|-1.3|||||TWO_SIDED|95.0|-4.8|2.0||||||Loss of \>= 15 letters in BCVA at Week 100||2.0|-4.8|
73965332|NCT03481660|147465874|OTHER|Treatment difference|Clopper-Pearson exact method|3.5|||||TWO_SIDED|95.0|-4.9|12.0||||||Absolute BCVA \>= 73 letters at Week 52||12.0|-4.9|
73913070|NCT03470441|147356133|OTHER||||||||||||||descriptive||||As little data exists on the incidence of arrhythmias that occur over an extended period of time following AMI, descriptive analysis of the primary endpoints (Arrhythmias of Interest at 48 hours and 14 days for overall and anterior infarcts) was appropriate in this study due to the absence of an externally validated benchmark which would normally serve as the basis for hypothesis testing of FDY-5301's effect on arrhythmias.|||
73913071|NCT03470441|147356138|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.32|TWO_SIDED|95.15|-10.8|3.1|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||3.1|-10.8|0.32
73913072|NCT03470441|147356140|SUPERIORITY||Median Difference (Final Values)|-4.4||||0.46|TWO_SIDED|95.16|-20.2|12.1|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test Comparing placebo to anterior infarcts FDY-5301 treated subjects (low, intermediate, and high) combined into one group.||12.10|-20.2|0.46
73913073|NCT03470441|147356146|SUPERIORITY||Median Difference (Final Values)|3.7||||0.25|TWO_SIDED|95.11|-3.6|10.6|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||10.6|-3.6|0.25
73913074|NCT03470441|147356148|SUPERIORITY||Median Difference (Final Values)|4.9||||0.31|TWO_SIDED|95.16|-7.0|16.9|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to anterior infarcts FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||16.9|-7|0.31
73913075|NCT03768414|147356152|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.41|TWO_SIDED|95.0|0.72|1.14|||Log Rank|||||1.14|0.72|0.41
73913076|NCT02571777|147356158|SUPERIORITY||LS Mean|0.065|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.031|0.099|||Mixed Model for Repeated Measures (MMRM)|||||0.099|0.031|<0.001
73965333|NCT03481660|147465874|OTHER|Treatment difference|Clopper-Pearson exact method|3.6|||||TWO_SIDED|95.0|-5.4|12.6||||||Absolute BCVA \>= 73 letters at Week 100||12.6|-5.4|
73913077|NCT02571777|147356158|SUPERIORITY||LS Mean|0.076|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.041|0.111|||MMRM|||||0.111|0.041|<0.001
73913078|NCT02571777|147356159|SUPERIORITY||LS Mean|0.014|STANDARD_ERROR_OF_MEAN|0.0406||0.729|TWO_SIDED|95.0|-0.066|0.094|||MMRM|||Week 26||0.094|-0.066|0.729
73913079|NCT02571777|147356159|SUPERIORITY||LS Mean|-0.086|STANDARD_ERROR_OF_MEAN|0.0404||0.034|TWO_SIDED|95.0|-0.165|-0.006|||MMRM|||Week 26||-0.006|-0.165|0.034
73913080|NCT02571777|147356159|SUPERIORITY||LS Mean|-0.071|STANDARD_ERROR_OF_MEAN|0.0409||0.085|TWO_SIDED|95.0|-0.151|0.01|||MMRM|||Week 26||0.010|-0.151|0.085
73913081|NCT02571777|147356159|SUPERIORITY||LS Mean|-0.084|STANDARD_ERROR_OF_MEAN|0.0406||0.038|TWO_SIDED|95.0|-0.164|-0.005|||MMRM|||Week 26||-0.005|-0.164|0.038
73913082|NCT02571777|147356159|SUPERIORITY||LS Mean|-0.059|STANDARD_ERROR_OF_MEAN|0.0415||0.157|TWO_SIDED|95.0|-0.14|0.023|||MMRM|||Week 52||0.023|-0.140|0.157
73913083|NCT02571777|147356159|SUPERIORITY||LS Mean|-0.121|STANDARD_ERROR_OF_MEAN|0.0414||0.003|TWO_SIDED|95.0|-0.202|-0.04|||MMRM|||Week 52||-0.040|-0.202|0.003
73913084|NCT02571777|147356159|SUPERIORITY||LS Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.042||0.814|TWO_SIDED|95.0|-0.092|0.072|||MMRM|||Week 52||0.072|-0.092|0.814
73913085|NCT02571777|147356159|SUPERIORITY||LS Mean|0.008|STANDARD_ERROR_OF_MEAN|0.0416||0.845|TWO_SIDED|95.0|-0.073|0.09|||MMRM|||Week 52||0.090|-0.073|0.845
73913086|NCT02571777|147356160|SUPERIORITY||LS Mean|0.119|STANDARD_ERROR_OF_MEAN|0.0177|<|0.001|TWO_SIDED|95.0|0.085|0.154|||MMRM|||||0.154|0.085|<0.001
73913087|NCT02571777|147356160|SUPERIORITY||LS Mean|0.099|STANDARD_ERROR_OF_MEAN|0.0177|<|0.001|TWO_SIDED|95.0|0.064|0.133|||MMRM|||||0.133|0.064|<0.001
73913088|NCT02571777|147356161|SUPERIORITY||LS Mean|0.086|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.051|0.12|||MMRM|||||0.120|0.051|<0.001
73913089|NCT02571777|147356161|SUPERIORITY||LS Mean|0.145|STANDARD_ERROR_OF_MEAN|0.0178|<|0.001|TWO_SIDED|95.0|0.111|0.18|||MMRM|||||0.180|0.111|<0.001
73913090|NCT02571777|147356161|SUPERIORITY||LS Mean|0.062|STANDARD_ERROR_OF_MEAN|0.0178|<|0.001|TWO_SIDED|95.0|0.027|0.096|||MMRM|||||0.096|0.027|<0.001
73913091|NCT02571777|147356161|SUPERIORITY||LS Mean|0.087|STANDARD_ERROR_OF_MEAN|0.0179|<|0.001|TWO_SIDED|95.0|0.052|0.122|||MMRM|||||0.122|0.052|<0.001
73913092|NCT02571777|147356162|SUPERIORITY||LS Mean|0.073|STANDARD_ERROR_OF_MEAN|0.0218|<|0.001|TWO_SIDED|95.0|0.03|0.116|||MMRM|||Week 4||0.116|0.030|<0.001
73913093|NCT02571777|147356162|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|95.0|0.096|0.181|||MMRM|||Week 4||0.181|0.096|<0.001
73913094|NCT02571777|147356162|SUPERIORITY||LS Mean|0.039|STANDARD_ERROR_OF_MEAN|0.022||0.074|TWO_SIDED|95.0|-0.004|0.082|||MMRM|||Week 4||0.082|-0.004|0.074
73913095|NCT02571777|147356162|SUPERIORITY||LS Mean|0.108|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.065|0.15|||MMRM|||Week 4||0.150|0.065|<0.001
73913096|NCT02571777|147356162|SUPERIORITY||LS Mean|0.056|STANDARD_ERROR_OF_MEAN|0.0219||0.01|TWO_SIDED|95.0|0.014|0.099|||MMRM|||Week 12||0.099|0.014|0.010
73913097|NCT02571777|147356162|SUPERIORITY||LS Mean|0.102|STANDARD_ERROR_OF_MEAN|0.0218|<|0.001|TWO_SIDED|95.0|0.059|0.145|||MMRM|||Week 12||0.145|0.059|<0.001
73913098|NCT02571777|147356162|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0221||0.022|TWO_SIDED|95.0|0.007|0.094|||MMRM|||Week 12||0.094|0.007|0.022
73913099|NCT02571777|147356162|SUPERIORITY||LS Mean|0.099|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|95.0|0.056|0.142|||MMRM|||Week 12||0.142|0.056|<0.001
73913100|NCT02571777|147356163|SUPERIORITY||LS Mean|0.095|STANDARD_ERROR_OF_MEAN|0.0254|<|0.001|TWO_SIDED|95.0|0.045|0.145|||MMRM|||||0.145|0.045|<0.001
73913101|NCT02571777|147356163|SUPERIORITY||LS Mean|0.147|STANDARD_ERROR_OF_MEAN|0.0256|<|0.001|TWO_SIDED|95.0|0.097|0.198|||MMRM|||||0.198|0.097|<0.001
73913102|NCT02571777|147356163|SUPERIORITY||LS Mean|0.049|STANDARD_ERROR_OF_MEAN|0.0256||0.057|TWO_SIDED|95.0|-0.001|0.099|||MMRM|||||0.099|-0.001|0.057
73913103|NCT02571777|147356163|SUPERIORITY||LS Mean|0.056|STANDARD_ERROR_OF_MEAN|0.0258||0.029|TWO_SIDED|95.0|0.006|0.107|||MMRM|||||0.107|0.006|0.029
73913104|NCT02571777|147356164|SUPERIORITY||LS Mean|18.2|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|13.2|23.3|||Linear Mixed Model (LMM)|||Week 26 - Mean morning PEF||23.3|13.2|<0.001
73913105|NCT02571777|147356164|SUPERIORITY||LS Mean|35.3|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|30.2|40.3|||LMM|||Week 26 - Mean morning PEF||40.3|30.2|<0.001
73965334|NCT03481660|147465876|OTHER|Treatment difference|LS mean difference|-29.4|STANDARD_ERROR_OF_MEAN|9.76|<|0.003|TWO_SIDED|95.0|-48.6|-10.2|||ANOVA|||CSFT over period Week 40 through Week 52||-10.2|-48.6|<0.003
73913106|NCT02571777|147356164|SUPERIORITY||LS Mean|14.9|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|9.8|20.0|||LMM|||Week 26 - Mean morning PEF||20.0|9.8|<0.001
73858904|NCT00901511|147263468|SUPERIORITY||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.8|-5.4|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of A-aDO2 in the GM-CSF Group minus the mean value of A-aDO2 in the Control Group|Primary analysis||-5.4|-14.8|<0.0001
73858905|NCT00901511|147263468|SUPERIORITY||Mean Difference (Final Values)|-12.46|STANDARD_ERROR_OF_MEAN|6.0||0.0545|TWO_SIDED|95.0|-25.19|0.27|||t-test, 2 sided||Calculated as the difference at the pre-WLL visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.27|-25.19|0.0545
73858906|NCT00901511|147263468|SUPERIORITY||Mean Difference (Final Values)|-7.08|STANDARD_ERROR_OF_MEAN|6.34||0.2802|TWO_SIDED|95.0|-20.52|6.35|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||6.35|-20.52|0.2802
73858907|NCT00901511|147263468|SUPERIORITY||Mean Difference (Final Values)|-16.81|STANDARD_ERROR_OF_MEAN|6.16||0.0148|TWO_SIDED|95.0|-29.85|-3.76|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||-3.76|-29.85|0.0148
73913107|NCT02571777|147356164|SUPERIORITY||LS Mean|28.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|22.9|33.1|||LMM|||Week 26 - Mean morning PEF||33.1|22.9|<0.001
73913108|NCT02571777|147356164|SUPERIORITY||LS Mean|16.8|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|11.8|21.7|||LMM|||Week 26 - Mean evening PEF||21.7|11.8|<0.001
73913109|NCT02571777|147356164|SUPERIORITY||LS Mean|29.1|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|24.2|34.1|||LMM|||Week 26 - Mean evening PEF||34.1|24.2|<0.001
73858908|NCT00901511|147263468|SUPERIORITY||Mean Difference (Final Values)|-18.77|STANDARD_ERROR_OF_MEAN|4.91||0.0015|TWO_SIDED|95.0|-29.18|-8.36|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 3 -month visit after imputation of missing data using a last observation carried forward method.||-8.36|-29.18|0.0015
73858909|NCT00901511|147263468|SUPERIORITY||Mean Difference (Final Values)|-19.09|STANDARD_ERROR_OF_MEAN|5.85||0.0049|TWO_SIDED|95.0|-31.49|-6.7|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||-6.70|-31.49|0.0049
73858910|NCT00901511|147263468|SUPERIORITY||Mean Difference (Final Values)|-15.85|STANDARD_ERROR_OF_MEAN|5.84||0.0152|TWO_SIDED|95.0|-28.23|-3.48|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||-3.48|-28.23|0.0152
73913110|NCT02571777|147356164|SUPERIORITY||LS Mean|14.1|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|9.1|19.1|||LMM|||Week 26 - Mean evening PEF||19.1|9.1|<0.001
73913111|NCT02571777|147356164|SUPERIORITY||LS Mean|24.3|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|19.3|29.3|||LMM|||Week 26 - Mean evening PEF||29.3|19.3|<0.001
73913112|NCT02571777|147356164|SUPERIORITY||LS Mean|18.7|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|13.4|24.1|||LMM|||Week 52 - Mean morning PEF||24.1|13.4|<0.001
73913113|NCT02571777|147356164|SUPERIORITY||LS Mean|34.8|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|29.5|40.1|||LMM|||Week 52 - Mean morning PEF||40.1|29.5|<0.001
73913114|NCT02571777|147356164|SUPERIORITY||LS Mean|15.6|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|10.2|20.9|||LMM|||Week 52 - Mean morning PEF||20.9|10.2|<0.001
73913115|NCT02571777|147356164|SUPERIORITY||LS Mean|28.5|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|23.2|33.8|||LMM|||Week 52 - Mean morning PEF||33.8|23.2|<0.001
73913116|NCT02571777|147356164|SUPERIORITY||LS Mean|17.5|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|12.3|22.8|||LMM|||Week 52 - Mean evening PEF||22.8|12.3|<0.001
73913117|NCT02571777|147356164|SUPERIORITY||LS Mean|29.5|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|24.2|34.7|||LMM|||Week 52 - Mean evening PEF||34.7|24.2|<0.001
73913118|NCT02571777|147356164|SUPERIORITY||LS Mean|15.0|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|9.7|20.2|||LMM|||Week 52 - Mean evening PEF||20.2|9.7|<0.001
73913119|NCT02571777|147356164|SUPERIORITY||LS Mean|25.8|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|20.5|31.0|||LMM|||Week 52 - Mean evening PEF||31.0|20.5|<0.001
73913120|NCT02571777|147356165|SUPERIORITY||LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.81||0.907|TWO_SIDED|95.0|-3.3|3.8|||LMM|||||3.8|-3.3|0.907
73913121|NCT02571777|147356165|SUPERIORITY||LS Mean|3.5|STANDARD_ERROR_OF_MEAN|1.81||0.055|TWO_SIDED|95.0|-0.1|7.0|||LMM|||||7.0|-0.1|0.055
73913122|NCT02571777|147356165|SUPERIORITY||LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.83||0.997|TWO_SIDED|95.0|-3.6|3.6|||LMM|||||3.6|-3.6|0.997
73913123|NCT02571777|147356165|SUPERIORITY||LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|1.82||0.606|TWO_SIDED|95.0|-4.5|2.6|||LMM|||||2.6|-4.5|0.606
73913124|NCT02571777|147356166|SUPERIORITY||LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.78||0.712|TWO_SIDED|95.0|-2.8|4.2|||LMM|||||4.2|-2.8|0.712
73913125|NCT02571777|147356166|SUPERIORITY||LS Mean|3.7|STANDARD_ERROR_OF_MEAN|1.78||0.038|TWO_SIDED|95.0|0.2|7.2|||LMM|||||7.2|0.2|0.038
73913126|NCT02571777|147356166|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.8||0.943|TWO_SIDED|95.0|-3.7|3.4|||LMM|||||3.4|-3.7|0.943
73913127|NCT02571777|147356166|SUPERIORITY||LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|1.79||0.612|TWO_SIDED|95.0|-4.4|2.6|||LMM|||||2.6|-4.4|0.612
73913128|NCT02571777|147356167|SUPERIORITY||LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.51||0.809|TWO_SIDED|95.0|-3.3|2.6|||LMM|||||2.6|-3.3|0.809
73913129|NCT02571777|147356167|SUPERIORITY||LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.5||0.467|TWO_SIDED|95.0|-1.9|4.0|||LMM|||||4.0|-1.9|0.467
73913130|NCT02571777|147356167|SUPERIORITY||LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.52||0.318|TWO_SIDED|95.0|-1.5|4.5|||LMM|||||4.5|-1.5|0.318
73913131|NCT02571777|147356167|SUPERIORITY||LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.51||0.64|TWO_SIDED|95.0|-2.3|3.7|||LMM|||||3.7|-2.3|0.640
73965335|NCT03481660|147465876|SUPERIORITY|||||||0.001|||||||ANOVA|||CSFT over period Week 40 through Week 52||||0.001
73913132|NCT02571777|147356168|SUPERIORITY||LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.83||0.814|TWO_SIDED|95.0|-4.0|3.2|||LMM|||||3.2|-4.0|0.814
73913133|NCT02571777|147356168|SUPERIORITY||LS Mean|3.8|STANDARD_ERROR_OF_MEAN|1.83||0.036|TWO_SIDED|95.0|0.2|7.4|||LMM|||||7.4|0.2|0.036
73913134|NCT02571777|147356168|SUPERIORITY||LS Mean|3.1|STANDARD_ERROR_OF_MEAN|1.84||0.098|TWO_SIDED|95.0|-0.6|6.7|||LMM|||||6.7|-0.6|0.098
73913135|NCT02571777|147356168|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.84||0.118|TWO_SIDED|95.0|-0.7|6.5|||LMM|||||6.5|-0.7|0.118
73913136|NCT02571777|147356169|SUPERIORITY||LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.74||0.645|TWO_SIDED|95.0|-4.2|2.6|||LMM|||Week 26||2.6|-4.2|0.645
73965336|NCT03481660|147465876|OTHER|Treatment difference|LS mean difference|-23.2|STANDARD_ERROR_OF_MEAN|10.28|||TWO_SIDED|95.0|-43.5|-3.0||||||CSFT over period Week 88 through Week 100||-3.0|-43.5|
73965337|NCT03481660|147465877|OTHER|Treatment difference|LS mean difference|-27.4|STANDARD_ERROR_OF_MEAN|9.35|||TWO_SIDED|95.0|-45.8|-9.0||||||CSFT over period Week 4 through Week 52||-9.0|-45.8|
73965338|NCT03481660|147465877|OTHER|Treatment difference|LS mean difference|-25.8|STANDARD_ERROR_OF_MEAN|9.29|||TWO_SIDED|95.0|-44.0|-7.5||||||CSFT over period Week 4 through Week 100||-7.5|-44.0|
73965339|NCT03481660|147465878|OTHER|Treatment difference|Clopper-Pearson exact method|16.3|||||TWO_SIDED|95.0|5.7|25.9||||||CSFT thickness (\<280 micrometers) at Week 52||25.9|5.7|
73913137|NCT02571777|147356169|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.095|TWO_SIDED|95.0|-0.5|6.3|||LMM|||Week 26||6.3|-0.5|0.095
73913138|NCT02571777|147356169|SUPERIORITY||LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.75||0.46|TWO_SIDED|95.0|-2.1|4.7|||LMM|||Week 26||4.7|-2.1|0.460
73913139|NCT02571777|147356169|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.75||0.971|TWO_SIDED|95.0|-3.5|3.4|||LMM|||Week 26||3.4|-3.5|0.971
73913140|NCT02571777|147356169|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.963|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.963
73913141|NCT02571777|147356169|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|1.77||0.075|TWO_SIDED|95.0|-0.3|6.6|||LMM|||Week 52||6.6|-0.3|0.075
73913142|NCT02571777|147356169|SUPERIORITY||LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.79||0.517|TWO_SIDED|95.0|-2.3|4.7|||LMM|||Week 52||4.7|-2.3|0.517
73913143|NCT02571777|147356169|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.956|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.956
73913144|NCT02571777|147356170|SUPERIORITY||Odds Ratio (OR)|0.92||||0.535|TWO_SIDED|95.0|0.7|1.2|||Logistic regression model|||Week 26||1.20|0.70|0.535
73913145|NCT02571777|147356170|SUPERIORITY||Odds Ratio (OR)|1.21||||0.151|TWO_SIDED|95.0|0.93|1.57|||Logistic regression model|||Week 26||1.57|0.93|0.151
73913146|NCT02571777|147356170|SUPERIORITY||Odds Ratio (OR)|1.13||||0.38|TWO_SIDED|95.0|0.86|1.48|||Logistic regression model|||Week 26||1.48|0.86|0.380
73913147|NCT02571777|147356170|SUPERIORITY||Odds Ratio (OR)|1.2||||0.172|TWO_SIDED|95.0|0.92|1.57|||Logistic regression model|||Week 26||1.57|0.92|0.172
73913148|NCT02571777|147356170|SUPERIORITY||Odds Ratio (OR)|1.1||||0.51|TWO_SIDED|95.0|0.83|1.47|||Logistic regression model|||Week 52||1.47|0.83|0.510
73913149|NCT02571777|147356170|SUPERIORITY||Odds Ratio (OR)|1.41||||0.017|TWO_SIDED|95.0|1.06|1.86|||Logistic regression model|||Week 52||1.86|1.06|0.017
73913150|NCT02571777|147356170|SUPERIORITY||Odds Ratio (OR)|1.05||||0.744|TWO_SIDED|95.0|0.79|1.38|||Logistic regression model|||Week 52||1.38|0.79|0.744
73965340|NCT03481660|147465878|OTHER|Treatment difference|Clopper-Pearson exact method|14.7|||||TWO_SIDED|95.0|4.2|24.9||||||CSFT thickness (\<280 micrometers) at Week 100||24.9|4.2|
73965341|NCT03481660|147465879|OTHER||Clopper-Pearson exact method|-1.2|||||TWO_SIDED|95.0|-4.5|2.1||||||Subretinal Fluid (SRF) at Week 52||2.1|-4.5|
73965342|NCT03481660|147465879|OTHER|Treatment Difference|Clopper-Pearson exact method|-0.2|||||TWO_SIDED|95.0|-3.4|3.4||||||Subretinal Fluid (SRF) at Week 100||3.4|-3.4|
73965343|NCT03481660|147465880|OTHER|Treatment Difference|Clopper-Pearson exact method|-19.1|||||TWO_SIDED|95.0|-28.9|-9.2||||||Intraretinal Fluid (IRF) at Week 52||-9.2|-28.9|
73965344|NCT03481660|147465880|OTHER|Treatment Difference|Clopper-Pearson exact method|-16.1|||||TWO_SIDED|95.0|-26.3|-5.7||||||Intraretinal Fluid (IRF) at Week 100||-5.7|-26.3|
73965345|NCT03481660|147465881|OTHER|Treatment Difference|Clopper-Pearson exact method|-18.4|||||TWO_SIDED|95.0|-28.5|-8.3||||||Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 52||-8.3|-28.5|
73965346|NCT03481660|147465881|OTHER|Treatment difference|Clopper-Pearson exact method|-16.2|||||TWO_SIDED|95.0|-26.4|-5.9||||||Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 100||-5.9|-26.4|
73965347|NCT03481660|147465882|OTHER|Treatment difference|Clopper-Pearson exact method|-25.4|||||TWO_SIDED|95.0|-34.4|-16.3||||||Fluorescein Angiography (FA) at Week 52||-16.3|-34.4|
73965348|NCT03481660|147465882|OTHER|Treatment difference|Clopper-Pearson exact method|-19.1|||||TWO_SIDED|95.0|-29.1|-8.2||||||Fluorescein Angiography (FA) at Week 100||-8.2|-29.1|
73965349|NCT03481660|147465883|OTHER|Treatment difference|Clopper-Pearson exact method|1.1|||||TWO_SIDED|95.0|-5.6|7.8||||||\>=2-step improvement in ETDRS-DRSS at Week 52||7.8|-5.6|
73965350|NCT03481660|147465883|OTHER|Treatment difference|Clopper-Pearson exact method|4.5|||||TWO_SIDED|95.0|-1.7|10.8||||||\>=2-step improvement in ETDRS-DRSS at Week 100||10.8|-1.7|
73965351|NCT03481660|147465884|OTHER|Treatment difference|Clopper-Pearson exact method|-0.6|||||TWO_SIDED|95.0|-7.1|5.7||||||\>=3-step improvement in ETDRS-DRSS at Week 52||5.7|-7.1|
73965352|NCT03481660|147465884|OTHER|Treatment difference|Clopper-Pearson exact method|3.9|||||TWO_SIDED|95.0|-2.3|10.0||||||\>=3-step improvement in ETDRS-DRSS at Week 100||10.0|-2.3|
73965353|NCT03481660|147465885|OTHER|Treatment difference|Clopper-Pearson exact method|1.1|||||TWO_SIDED|95.0|-1.0|3.6||||||\>=2-step worsening in ETDRS-DRSS at Week 52||3.6|-1.0|
73965354|NCT03481660|147465885|OTHER|Treatment difference|Clopper-Pearson exact method|2.9|||||TWO_SIDED|95.0|-0.5|6.9||||||\>=2-step worsening in ETDRS-DRSS at Week 100||6.9|-0.5|
73913151|NCT02571777|147356170|SUPERIORITY||Odds Ratio (OR)|0.99||||0.922|TWO_SIDED|95.0|0.75|1.29|||Logistic regression model|||Week 52||1.29|0.75|0.922
73913152|NCT02571777|147356171|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.371|TWO_SIDED|95.0|0.27|1.63|||Regression, Cox|||||1.63|0.27|0.371
73913153|NCT02571777|147356171|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.996|TWO_SIDED|95.0|0.37|2.66|||Regression, Cox|||||2.66|0.37|0.996
73913154|NCT02571777|147356171|SUPERIORITY||Hazard Ratio (HR)|1.89||||0.145|TWO_SIDED|95.0|0.8|4.47|||Regression, Cox|||||4.47|0.80|0.145
73913155|NCT02571777|147356171|SUPERIORITY||Hazard Ratio (HR)|1.88||||0.15|TWO_SIDED|95.0|0.8|4.43|||Regression, Cox|||||4.43|0.80|0.150
73913156|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.523|TWO_SIDED|95.0|0.77|1.15|||Regression, Cox|||Moderate or severe asthma exacerbation||1.15|0.77|0.523
73965355|NCT03481660|147465886|OTHER|Treatment difference|Clopper-Pearson exact method|0.6|||||TWO_SIDED|95.0|0.5|2.1||||||\>=3-step worsening in ETDRS-DRSS at Week 52||2.1|0.5|
73913157|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.58|0.84|||Regression, Cox|||Moderate or severe asthma exacerbation||0.84|0.58|<0.001
73913158|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.164|TWO_SIDED|95.0|0.72|1.06|||Regression, Cox|||Moderate or severe asthma exacerbation||1.06|0.72|0.164
73913159|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.005|TWO_SIDED|95.0|0.63|0.92|||Regression, Cox|||Moderate or severe asthma exacerbation||0.92|0.63|0.005
74085653|NCT01976728|147725588|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0246||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||Biochemical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0246
74085654|NCT01976728|147725589|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0011||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||LH surge detection of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0011
73913160|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.476|TWO_SIDED|95.0|0.72|1.16|||Regression, Cox|||Severe asthma exacerbation||1.16|0.72|0.476
73913161|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.001|TWO_SIDED|95.0|0.54|0.85|||Regression, Cox|||Severe asthma exacerbation||0.85|0.54|<0.001
73913162|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.243|TWO_SIDED|95.0|0.7|1.09|||Regression, Cox|||Severe asthma exacerbation||1.09|0.70|0.243
73913163|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.027|TWO_SIDED|95.0|0.63|0.97|||Regression, Cox|||Severe asthma exacerbation||0.97|0.63|0.027
73913164|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.497|TWO_SIDED|95.0|0.79|1.12|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||1.12|0.79|0.497
73913165|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.001|TWO_SIDED|95.0|0.6|0.84|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||0.84|0.60|<0.001
73913166|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.126|TWO_SIDED|95.0|0.73|1.04|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||1.04|0.73|0.126
73913167|NCT02571777|147356172|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.61|0.85|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||0.85|0.61|<0.001
73913168|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.85||||0.12|TWO_SIDED|95.0|0.68|1.04|||Generalized linear model|||Moderate or severe asthma exacerbation||1.04|0.68|0.120
73913169|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.52|0.78|||Generalized linear model|||Moderate or severe asthma exacerbation||0.78|0.52|<0.001
73913170|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.87||||0.17|TWO_SIDED|95.0|0.71|1.06|||Generalized linear modeñ|||Moderate or severe asthma exacerbation||1.06|0.71|0.170
73913171|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.81||||0.041|TWO_SIDED|95.0|0.66|0.99|||Generalized linear model|||Moderate or severe asthma exacerbation||0.99|0.66|0.041
73913172|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.78||||0.05|TWO_SIDED|95.0|0.61|1.0|||Generalized linear model|||Severe asthma exacerbation||1.00|0.61|0.050
73913173|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.73|||Generalized linear model|||Severe asthma exacerbation||0.73|0.45|<0.001
73913174|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.93||||0.531|TWO_SIDED|95.0|0.74|1.17|||Generalized linear model|||Severe asthma exacerbation||1.17|0.74|0.531
73913175|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.84||||0.117|TWO_SIDED|95.0|0.67|1.05|||Linear generalized model|||Severe asthma exacerbation||1.05|0.67|0.117
73913176|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.79||||0.016|TWO_SIDED|95.0|0.66|0.96|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.96|0.66|0.016
73913177|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.6|||<|0.001|TWO_SIDED|95.0|0.5|0.72|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.72|0.50|<0.001
73913178|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.87||||0.161|TWO_SIDED|95.0|0.72|1.06|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||1.06|0.72|0.161
73913179|NCT02571777|147356173|SUPERIORITY||Rate ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.58|0.84|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.84|0.58|<0.001
73965356|NCT03481660|147465886|OTHER|Treatment difference|Clopper-Pearson exact method|-0.6|||||TWO_SIDED|95.0|-2.6|1.3||||||\>=3-step worsening in ETDRS-DRSS at Week 100||1.3|-2.6|
73965357|NCT03481660|147465887|OTHER|Treatment difference|Clopper-Pearson exact method|0.0|||||TWO_SIDED|95.0|-2.1|1.9||||||Proliferative diabetic retinopathy (PDR) of at least 61 by Week 100||1.9|-2.1|
73965358|NCT01259401|147465907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||ANCOVA|||||||.04
73965359|NCT01259401|147465908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.061|TWO_SIDED||||||ANCOVA|||||||.061
73913180|NCT02571777|147356174|SUPERIORITY|||||||0.183|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.183
73913181|NCT02571777|147356174|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
74026858|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.60|0.44|
74026859|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.63|0.88|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.88|0.63|
73913182|NCT02571777|147356174|SUPERIORITY|||||||0.155|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.155
73913183|NCT02571777|147356174|SUPERIORITY|||||||0.007|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.007
73913184|NCT02571777|147356174|SUPERIORITY|||||||0.172|||||||van Elteren test|||Severe asthma exacerbation||||0.172
73913185|NCT02571777|147356174|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Severe asthma exacerbation||||<0.001
73913186|NCT02571777|147356174|SUPERIORITY|||||||0.241|||||||van Elteren test|||Severe asthma exacerbation||||0.241
73913187|NCT02571777|147356174|SUPERIORITY|||||||0.033|||||||van Elteren test|||Severe asthma exacerbation||||0.033
73913188|NCT02571777|147356174|SUPERIORITY|||||||0.095|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.095
73913189|NCT02571777|147356174|SUPERIORITY||||||<|0.001|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||<0.001
73913190|NCT02571777|147356174|SUPERIORITY|||||||0.09|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.090
73913191|NCT02571777|147356174|SUPERIORITY||||||<|0.001|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||<0.001
73913192|NCT02571777|147356176|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.314|TWO_SIDED|95.0|0.12|1.96|||Regression, Cox|||||1.96|0.12|0.314
73913193|NCT02571777|147356176|SUPERIORITY||Hazard Ratio (HR)|0.28||||0.055|TWO_SIDED|95.0|0.08|1.03|||Regression, Cox|||||1.03|0.08|0.055
73965360|NCT05768373|147465909|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-3.4|4.0|||||The difference is 3M Clinpro minus 3M Vanish.|||4.0|-3.4|
73965361|NCT05768373|147465910|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.6|5.3|||||The difference is 3M Clinpro minus 3M Vanish.|||5.3|-2.6|
73965362|NCT05768373|147465911|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-3.2|6.7|||||The difference is 3M Clinpro minus 3M Vanish.|||6.7|-3.2|
73913194|NCT02571777|147356176|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.306|TWO_SIDED|95.0|0.25|1.54|||Regression, Cox|||||1.54|0.25|0.306
73913195|NCT02571777|147356176|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.566|TWO_SIDED|95.0|0.3|1.94|||Regression, Cox|||||1.94|0.30|0.566
73858911|NCT00901511|147263468|SUPERIORITY||Mean Difference (Final Values)|-17.01|STANDARD_ERROR_OF_MEAN|6.27||0.0154|TWO_SIDED|95.0|-30.31|-3.71|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||-3.71|-30.31|0.0154
73858912|NCT00901511|147263468|SUPERIORITY||Mean Difference (Final Values)|-11.01|STANDARD_ERROR_OF_MEAN|6.15||0.0921|TWO_SIDED|95.0|-24.05|2.02|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||2.02|-24.05|0.0921
73858913|NCT00901511|147263469|SUPERIORITY||Mean Difference (Final Values)|11.6||||0.022|TWO_SIDED|95.0|1.9|21.3|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of the DLCO in the GM-CSF Group minus the mean value of the DLCO in the Control Group|Primary Analysis||21.3|1.9|0.0220
73858914|NCT00901511|147263469|SUPERIORITY||Mean Difference (Final Values)|8.29|STANDARD_ERROR_OF_MEAN|7.96||0.3186|TWO_SIDED|95.0|-9.06|25.63|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||25.63|-9.06|0.3186
73858915|NCT00901511|147263469|SUPERIORITY||Mean Difference (Final Values)|5.56|STANDARD_ERROR_OF_MEAN|6.58||0.4111|TWO_SIDED|95.0|-8.4|19.51|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||19.51|-8.40|0.4111
73913196|NCT02571777|147356178|SUPERIORITY||LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.74||0.645|TWO_SIDED|95.0|-4.2|2.6|||LMM|||Week 26||2.6|-4.2|0.645
73913197|NCT02571777|147356178|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.095|TWO_SIDED|95.0|-0.5|6.3|||LMM|||Week 26||6.3|-0.5|0.095
73913198|NCT02571777|147356178|SUPERIORITY||LMM|1.3|STANDARD_ERROR_OF_MEAN|1.75||0.46|TWO_SIDED|95.0|-2.1|4.7|||LMM|||Week 26||4.7|-2.1|0.460
73913199|NCT02571777|147356178|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.75||0.971|TWO_SIDED|95.0|-3.5|3.4|||LMM|||Week 26||3.4|-3.5|0.971
73913200|NCT02571777|147356178|SUPERIORITY||LMM|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.963|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.963
73913201|NCT02571777|147356178|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|1.77||0.075|TWO_SIDED|95.0|-0.3|6.6|||LMM|||Week 52||6.6|-0.3|0.075
73913202|NCT02571777|147356178|SUPERIORITY||LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.79||0.517|TWO_SIDED|95.0|-2.3|4.7|||LMM|||Week 52||4.7|-2.3|0.517
73913203|NCT02571777|147356178|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.956|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.956
73913204|NCT02571777|147356179|SUPERIORITY||LS Mean|0.02|STANDARD_ERROR_OF_MEAN|0.0502||0.69|TWO_SIDED|95.0|-0.078|0.118|||MMRM|||||0.118|-0.078|0.690
73913205|NCT02571777|147356179|SUPERIORITY||LS Mean|0.06|STANDARD_ERROR_OF_MEAN|0.0502||0.232|TWO_SIDED|95.0|-0.038|0.159|||MMRM|||||0.159|-0.038|0.232
73858916|NCT00901511|147263469|SUPERIORITY||Mean Difference (Final Values)|12.89|STANDARD_ERROR_OF_MEAN|6.53||0.0658|TWO_SIDED|95.0|-0.95|26.73|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||26.73|-0.95|0.0658
73858917|NCT00901511|147263469|SUPERIORITY||Mean Difference (Final Values)|9.78|STANDARD_ERROR_OF_MEAN|7.81||0.2287|TWO_SIDED|95.0|-6.78|26.34|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||26.34|-6.78|0.2287
73913206|NCT02571777|147356179|SUPERIORITY||LS Mean|-0.054|STANDARD_ERROR_OF_MEAN|0.0506||0.285|TWO_SIDED|95.0|-0.153|0.045|||MMRM|||||0.045|-0.153|0.285
73913207|NCT02571777|147356179|SUPERIORITY||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.0505||0.319|TWO_SIDED|95.0|-0.15|0.049|||MMRM|||||0.049|-0.150|0.319
73913208|NCT02571777|147356180|SUPERIORITY||LS Mean|0.068|STANDARD_ERROR_OF_MEAN|0.0166|<|0.001|TWO_SIDED|95.0|0.036|0.101|||MMRM|||Week 4||0.101|0.036|<0.001
73913209|NCT02571777|147356180|SUPERIORITY||LS Mean|0.145|STANDARD_ERROR_OF_MEAN|0.0165|<|0.001|TWO_SIDED|95.0|0.113|0.177|||MMRM|||Week 4||0.177|0.113|<0.001
73913210|NCT02571777|147356180|SUPERIORITY||LS Mean|0.033|STANDARD_ERROR_OF_MEAN|0.0167||0.049|TWO_SIDED|95.0|0.0|0.066|||MMRM|||Week 4||0.066|0.000|0.049
73913211|NCT02571777|147356180|SUPERIORITY||LS Mean|0.096|STANDARD_ERROR_OF_MEAN|0.0166|<|0.001|TWO_SIDED|95.0|0.064|0.129|||MMRM|||Week 4||0.129|0.064|<0.001
73913212|NCT02571777|147356180|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0184||0.002|TWO_SIDED|95.0|0.022|0.094|||MMRM|||Week 12||0.094|0.022|0.002
73913213|NCT02571777|147356180|SUPERIORITY||LS Mean|0.117|STANDARD_ERROR_OF_MEAN|0.0183|<|0.001|TWO_SIDED|95.0|0.081|0.153|||MMRM|||Week 12||0.153|0.081|<0.001
73913214|NCT02571777|147356180|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0185||0.007|TWO_SIDED|95.0|0.013|0.086|||MMRM|||Week 12||0.086|0.013|0.007
73913215|NCT02571777|147356180|SUPERIORITY||MMRM|0.087|STANDARD_ERROR_OF_MEAN|0.0184|<|0.001|TWO_SIDED|95.0|0.051|0.123|||MMRM|||Week 12||0.123|0.051|<0.001
73913216|NCT00963937|147356203|SUPERIORITY_OR_OTHER||Percent Difference|-7.49||||0.345|TWO_SIDED|95.0|-23.02|8.04||Multiplicity was not considered because the primary analysis included a single statistical comparison.|Chi-squared||Percent difference = sumatriptan pooled group minus the placebo group|||8.04|-23.02|0.345
73913217|NCT00864383|147356211|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the difference in proportion of patients with an unfavorable outcome.|Adjusted difference in proportions|6.1|||||TWO_SIDED|97.5|1.7|10.5|||||Adjusted difference from control in proportion of unfavorable outcome - percentage points|||10.5|1.7|
73913218|NCT00864383|147356211|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the proportion of patients with an unfavorable outcome.|Adjusted difference from control|11.4|||||TWO_SIDED|97.5|6.7|16.1|||||Adjusted difference from control in rate of unfavorable outcome- percentage points|||16.1|6.7|
73913219|NCT03386448|147356380|SUPERIORITY|Student test was performed|Mean Difference (Final Values)|9.0||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
73913220|NCT03583697|147356382|SUPERIORITY||Least Square Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.02|0.53||||||"Z-Scores were derived using age-sex specific reference data (means and SDs) for average stature children per the Centers for Disease Control and Prevention.~Participants aged \< 24 months, body length takes precedence over standing height. Participants aged \< 24 months at baseline and \>= 24 months at Week 52, body length takes precedence.~Difference in least squares (LS) means were obtained from an analysis of covariance model."||0.53|-0.02|
73913221|NCT03583697|147356382|SUPERIORITY||Least Square Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|0.07|0.54||||||"Z-Scores were derived using age-sex specific reference data (means and SDs) for average stature children per the Centers for Disease Control and Prevention.~Participants aged \< 24 months, body length takes precedence over standing height. Participants aged \< 24 months at baseline and \>= 24 months at Week 52, body length takes precedence.~Difference in LS means were obtained from an analysis of covariance model."||0.54|0.07|
73913222|NCT03583697|147356383|SUPERIORITY||Least Square Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|-0.02|1.56||||||Difference in LS means were obtained from an analysis of covariance model.||1.56|-0.02|
73913223|NCT03583697|147356383|SUPERIORITY||Least Square Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.26|1.66||||||Difference in LS means were obtained from an analysis of covariance model.||1.66|0.26|
73913224|NCT03583697|147356384|SUPERIORITY||Least Square Mean Difference (Net)|0.78|||||TWO_SIDED|95.0|0.02|1.54||||||||1.54|0.02|
74026860|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.15|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.26|0.15|
73913225|NCT03583697|147356384|SUPERIORITY||Least Square Mean Difference (Net)|0.92|||||TWO_SIDED|95.0|0.24|1.59||||||Difference in LS means were obtained from an analysis of covariance model.||1.59|0.24|
73913226|NCT03583697|147356385|SUPERIORITY||Least Square Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.17|0.04||||||Difference in LS means were obtained from an analysis of covariance model.||0.04|-0.17|
73913227|NCT03583697|147356385|SUPERIORITY||Least Square Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.15|0.03||||||Difference in LS means were obtained from an analysis of covariance model.||0.03|-0.15|
73913228|NCT00114530|147356436|SUPERIORITY|||||||0.013||||||A Data and Safety Monitoring Board reviewed 4 pre-specified futility analyses that included an ability to stop for efficacy with p\<0.0001, leaving alpha equal to 0.0496 for the primary ITT analysis of the GRCS at 54 months post-randomization.|Wilcoxon (Mann-Whitney)|||||||0.013
73913229|NCT00114530|147356437|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73913230|NCT00114530|147356438|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
73913231|NCT00114530|147356439|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73913232|NCT00114530|147356440|SUPERIORITY|||||||0.059|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.||||0.059
73913233|NCT00114530|147356440|SUPERIORITY|||||||0.06|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72||||0.06
73913234|NCT00114530|147356441|SUPERIORITY|||||||0.021|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.||||0.021
73913235|NCT00114530|147356441|SUPERIORITY|||||||0.03|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72||||0.03
73913236|NCT00114530|147356442|SUPERIORITY|||||||0.059|||||||Fisher Exact|||||||0.059
73913237|NCT00114530|147356443|SUPERIORITY|||||||0.021|||||||Fisher Exact|||||||0.021
73913238|NCT00114530|147356444|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
73913239|NCT00114530|147356445|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
73913240|NCT00114530|147356446|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
73913241|NCT00114530|147356447|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
73913242|NCT00114530|147356448|SUPERIORITY|||||||0.28|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.||||0.28
73913243|NCT00114530|147356448|SUPERIORITY|||||||0.05|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.||||0.05
73913244|NCT00114530|147356449|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.||||0.19
73913245|NCT00114530|147356449|SUPERIORITY|||||||0.02|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.||||0.02
73913246|NCT00114530|147356450|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.28
73913247|NCT00114530|147356451|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
73913248|NCT00114530|147356452|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
73913249|NCT00114530|147356452|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.01
73913250|NCT00114530|147356453|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
73913251|NCT00114530|147356453|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.002
73913252|NCT00114530|147356454|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.001
73913253|NCT00114530|147356454|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.||||0.02
73913254|NCT00114530|147356454|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.05
73913255|NCT00114530|147356454|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.||||0.1
73913256|NCT00114530|147356455|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
73913257|NCT00114530|147356455|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.||||0.003
73913258|NCT00114530|147356455|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.02
73913259|NCT00114530|147356455|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.||||0.07
73913260|NCT00114530|147356456|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.08
73913261|NCT00114530|147356456|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.9
73913262|NCT00114530|147356457|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.1
73913263|NCT00114530|147356457|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.6
73913264|NCT00114530|147356458|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.02
73913265|NCT00114530|147356458|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.3
73913266|NCT00114530|147356459|SUPERIORITY|||||||0.03|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.03
73913267|NCT00114530|147356459|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.5
73913268|NCT00114530|147356460|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.002
73913269|NCT00114530|147356460|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.05
73913270|NCT00114530|147356461|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
73913271|NCT00114530|147356461|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.01
73913272|NCT00114530|147356462|SUPERIORITY|||||||0.42|||||||Chi-squared|||Development of new or worsening arrhythmias||||0.42
73913273|NCT00114530|147356462|SUPERIORITY|||||||0.048|||||||Chi-squared|||CHF requiring clinical treatment||||0.048
73913274|NCT00114530|147356462|SUPERIORITY|||||||0.51|||||||Chi-squared|||Clinically significant pericardial effusion||||0.51
73913275|NCT00114530|147356463|SUPERIORITY|||||||0.46|||||||Chi-squared|||Development of new or worsening arrhythmias||||0.46
73913276|NCT00114530|147356463|SUPERIORITY|||||||0.042|||||||Chi-squared|||CHF requiring clinical treatment||||0.042
73913277|NCT00114530|147356463|SUPERIORITY|||||||0.15|||||||Chi-squared|||Clinically significant pericardial effusion||||0.15
73913278|NCT00114530|147356464|SUPERIORITY|||||||0.026|||||||Chi-squared|||||||0.026
73913279|NCT00114530|147356465|SUPERIORITY|||||||0.022|||||||Chi-squared|||||||0.022
73913280|NCT00114530|147356466|SUPERIORITY|||||||0.71|||||||Chi-squared|||||||0.71
73913281|NCT00114530|147356467|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
73913282|NCT00114530|147356468|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
73913283|NCT00114530|147356469|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
73913284|NCT00114530|147356470|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
73913285|NCT00114530|147356471|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
73913286|NCT00114530|147356472|SUPERIORITY||||||<|0.001|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.||||||<0.001
73913287|NCT00114530|147356472|SUPERIORITY||Person-Time (Years)|174.4|||||TWO_SIDED||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.61, Probably related = 0.57, Definitely related = 0.52|||||
73913288|NCT00114530|147356472|SUPERIORITY||Person-Time (Years)|141.3|||||TWO_SIDED||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.17, Probably related = 0.09, Definitely related = 0.04|||||
73913289|NCT00114530|147356474|SUPERIORITY|||||||0.7|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.||||||0.7
73913290|NCT00114530|147356474|SUPERIORITY||Person-Time (Years)|174.4|||||TWO_SIDED||||||||The Person-Time (P-T) rate (events/P-T) is 0.76|||||
73913291|NCT00114530|147356474|SUPERIORITY||Person-Time (Years)|141.3|||||TWO_SIDED||||||||The Person-Time (P-T) rate (events/P-T) is 0.80|||||
73913292|NCT01064310|147356484|SUPERIORITY_OR_OTHER||Percentage of participants|49.26|||<|0.001|TWO_SIDED|90.0|37.0|61.5||The p value indicates the difference in preference for pazopanib versus sunitinib treatment|Prescotts test||The estimated value indicates the difference in the percentage of participants who preferred pazopanib versus sunitinib. This difference is adjusted for sequence.|||61.5|37.0|<0.001
73858918|NCT00901511|147263469|SUPERIORITY||Mean Difference (Final Values)|12.86|STANDARD_ERROR_OF_MEAN|8.37||0.1432|TWO_SIDED|95.0|-4.86|30.64|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||30.64|-4.86|0.1432
73913293|NCT00679432|147356495|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.8||||0.1393|TWO_SIDED|95.0|-1.8|13.4|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Asacol and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Asacol versus budesonide MMX.||13.4|-1.8|0.1393
74085655|NCT01976728|147725590|SUPERIORITY|||||||0.1344||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1344
73858919|NCT00901511|147263469|SUPERIORITY||Mean Difference (Final Values)|11.78|STANDARD_ERROR_OF_MEAN|8.47||0.1833|TWO_SIDED|95.0|-6.17|29.73|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||29.73|-6.17|0.1833
73858920|NCT00901511|147263469|SUPERIORITY||Mean Difference (Final Values)|12.67|STANDARD_ERROR_OF_MEAN|9.23||0.1888|TWO_SIDED|95.0|-6.9|32.23|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||32.23|-6.90|0.1888
73858921|NCT00901511|147263469|SUPERIORITY||Mean Difference (Final Values)|4.22|STANDARD_ERROR_OF_MEAN|8.79||0.6374|TWO_SIDED|95.0|-14.41|22.85|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||22.85|-14.41|0.6374
73858922|NCT00901511|147263470|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.532|TWO_SIDED|95.0|-5.3|9.9|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of VC in the GM-CSF Group minus the mean value of VC in the Control Group|Primary Analysis||9.90|-5.30|0.5320
73858923|NCT00901511|147263470|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|7.55||0.6772|TWO_SIDED|95.0|-13.09|19.52|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||19.52|-13.09|0.6772
73858924|NCT00901511|147263470|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|6.7||0.832|TWO_SIDED|95.0|-12.52|15.64|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||15.64|-12.52|0.8320
73858925|NCT00901511|147263470|SUPERIORITY||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|7.82||0.8532|TWO_SIDED|95.0|-15.19|18.14|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||18.14|-15.19|0.8532
73858926|NCT00901511|147263470|SUPERIORITY||Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|7.66||0.7752|TWO_SIDED|95.0|-14.0|18.44|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||18.44|-14.00|0.7752
73858927|NCT00901511|147263470|SUPERIORITY||Mean Difference (Final Values)|5.74|STANDARD_ERROR_OF_MEAN|8.65||0.5174|TWO_SIDED|95.0|-12.7|24.18|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean value of VC in the GM-CSF Group minus the mean value of VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||24.18|-12.70|0.5174
73858928|NCT00901511|147263470|SUPERIORITY||Mean Difference (Final Values)|3.67|STANDARD_ERROR_OF_MEAN|7.68||0.6393|TWO_SIDED|95.0|-12.61|19.94|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||19.94|-12.61|0.6393
73913294|NCT00679432|147356495|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|10.4||||0.0143|TWO_SIDED|95.0|2.2|18.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||18.7|2.2|0.0143
73913295|NCT00679432|147356495|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|4.7||||0.22|TWO_SIDED|95.0|-2.7|12.1|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||12.1|-2.7|0.2200
73913296|NCT00679432|147356496|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.8||||0.3146|TWO_SIDED|95.0|-5.5|17.0|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.||17.0|-5.5|0.3146
73913297|NCT00679432|147356496|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.5||||0.142|TWO_SIDED|95.0|-2.8|19.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||19.9|-2.8|0.1420
73913298|NCT00679432|147356496|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|9.1||||0.1189|TWO_SIDED|95.0|-2.3|20.4|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||20.4|-2.3|0.1189
73913299|NCT00679432|147356497|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|0.0||||0.9991|TWO_SIDED|95.0|-11.8|11.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Asacol and placebo groups is shown here.||11.8|-11.8|0.9991
73913300|NCT01980940|147356499|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|5.09|||||TWO_SIDED|90.0|4.03|6.42|||ANOVA|||The geometric least squares mean ratio (GLSMR) and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||6.42|4.03|
73913301|NCT01980940|147356499|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|7.3|||||TWO_SIDED|90.0|6.05|8.81|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||8.81|6.05|
73913302|NCT01980940|147356499|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.45|||||TWO_SIDED|90.0|0.38|0.55|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.55|0.38|
73913303|NCT01980940|147356499|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.65|||||TWO_SIDED|90.0|0.51|0.83|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.83|0.51|
74026861|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.23|0.35|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.35|0.23|
73913304|NCT01980940|147356501|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|9.32|||||TWO_SIDED|90.0|4.77|18.18|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||18.18|4.77|
73913305|NCT01980940|147356501|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|8.12|||||TWO_SIDED|90.0|6.39|10.32|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||10.32|6.39|
74026862|NCT01025336|147607520|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.43|0.28|
74026863|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.56|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.56|0.42|
74085656|NCT01976728|147725590|SUPERIORITY|||||||0.2726||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2726
73913306|NCT01980940|147356501|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.47|||||TWO_SIDED|90.0|0.39|0.57|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.57|0.39|
73913307|NCT01980940|147356501|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.41|||||TWO_SIDED|90.0|0.21|0.79|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.79|0.21|
74085657|NCT01976728|147725590|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
73913308|NCT01980940|147356502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.3|STANDARD_ERROR_OF_MEAN|21.57||0.2113|TWO_SIDED|90.0|-63.6|8.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||8.9|-63.6|0.2113
73913309|NCT01980940|147356502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|19.66||0.2548|TWO_SIDED|90.0|-55.7|10.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||10.3|-55.7|0.2548
73913310|NCT01980940|147356502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.4|STANDARD_ERROR_OF_MEAN|19.94||0.288|TWO_SIDED|90.0|-54.9|12.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||12.0|-54.9|0.2880
73913311|NCT01980940|147356502|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|19.52||0.3709|TWO_SIDED|90.0|-50.4|15.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||15.1|-50.4|0.3709
73913312|NCT01980940|147356502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|19.81||0.3883|TWO_SIDED|90.0|-50.5|16.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||16.0|-50.5|0.3883
73965363|NCT05768373|147465912|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-3.0|7.4|||||The difference is 3M Clinpro minus 3M Vanish.|||7.4|-3.0|
73965364|NCT05768373|147465913|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-4.4|8.2|||||The difference is 3M Clinpro minus 3M Vanish.|||8.2|-4.4|
73965365|NCT03398200|147465925|SUPERIORITY|||||||0.89|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.89
73965366|NCT03398200|147465926|SUPERIORITY|||||||0.03|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.03
73965367|NCT03398200|147465927|SUPERIORITY|||||||0.35|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.35
73965368|NCT03398200|147465928|SUPERIORITY|||||||0.77|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.77
73965369|NCT03398200|147465929|SUPERIORITY|||||||0.5|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.50
73965370|NCT03398200|147465930|SUPERIORITY|||||||0.76|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.76
73965371|NCT05478525|147465932|SUPERIORITY||Least Squares (LS) Mean Difference|-35.05||||0.0007|TWO_SIDED|95.0|-54.35|-15.75|||ANCOVA|||Analysis at Week 2||-15.75|-54.35|0.0007
73965372|NCT05478525|147465932|SUPERIORITY||LS Mean Difference|-23.14||||0.0193|TWO_SIDED|95.0|-42.32|-3.97|||ANCOVA|||Analysis at Week 2||-3.97|-42.32|0.0193
73965373|NCT05478525|147465932|SUPERIORITY||LS Mean Difference|-21.64||||0.0243|TWO_SIDED|95.0|-40.33|-2.96|||ANCOVA|||Analysis at Week 2||-2.96|-40.33|0.0243
73965374|NCT05478525|147465934|SUPERIORITY||LS Mean Difference|-155.68||||0.0298|TWO_SIDED|95.0|-295.35|-16.01|||ANCOVA|||Analysis at Day 14||-16.01|-295.35|0.0298
73965375|NCT05478525|147465934|SUPERIORITY||LS Mean Difference|-143.74||||0.0433|TWO_SIDED|95.0|-282.92|-4.55|||ANCOVA|||Analysis at Day 14||-4.55|-282.92|0.0433
73965376|NCT05478525|147465934|SUPERIORITY||LS Mean Difference|-178.33||||0.0201|TWO_SIDED|95.0|-327.16|-29.5|||ANCOVA|||Analysis at Day 14||-29.50|-327.16|0.0201
73965377|NCT05478525|147465935|SUPERIORITY||LS Mean Difference|-47.07||||0.1992|TWO_SIDED|95.0|-119.94|25.81|||ANCOVA|||Analysis at Day 14||25.81|-119.94|0.1992
73913313|NCT01980940|147356503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|9.32||0.1383|TWO_SIDED|90.0|-29.7|1.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||1.6|-29.7|0.1383
73913314|NCT01980940|147356503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|8.66||0.238|TWO_SIDED|90.0|-24.9|4.2|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||4.2|-24.9|0.2380
73965378|NCT05478525|147465935|SUPERIORITY||LS Mean Difference|-70.32||||0.0617|TWO_SIDED|95.0|-144.26|3.61|||ANCOVA|||Analysis at Day 14||3.61|-144.26|0.0617
73965379|NCT05478525|147465935|SUPERIORITY||LS Mean Difference|-39.84||||0.2981|TWO_SIDED|95.0|-116.22|36.53|||ANCOVA|||Analysis at Day 14||36.53|-116.22|0.2981
73965380|NCT05644002|147465941|OTHER||Mean Difference (Final Values)|2.06||||0.71|TWO_SIDED|95.0|-9.09|13.21||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.||13.21|-9.09|.71
73965381|NCT05644002|147465941|OTHER||t-statistic|0.369|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction Omax between the PTBT and Control conditions.||||
73965382|NCT05644002|147465941|OTHER||Hedge's g|0.09|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.||||
73965383|NCT05644002|147465942|OTHER||Mean Difference (Final Values)|0.251||||0.53|TWO_SIDED|95.0|-0.543|1.046||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||1.046|-.543|.530
73965384|NCT05644002|147465942|OTHER||t-statistic|0.631|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 73||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||||
73965385|NCT05644002|147465942|OTHER||Hedge's g|0.14|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||||
74085658|NCT01976728|147725590|SUPERIORITY|||||||0.1275||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1275
73965386|NCT05644002|147465943|OTHER||Mean Difference (Final Values)|0.889||||0.66|TWO_SIDED|95.0|-3.149|4.927||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress intensity between the PTBT and Control conditions.||4.927|-3.149|.66
73965387|NCT05644002|147465943|OTHER||t-statistic|0.439|||||TWO_SIDED||||||t-test, 2 sided|degrees of freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction intensity between the PTBT and Control conditions.||||
73965388|NCT05644002|147465943|OTHER||Hedge's g|-0.11|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction intensity between the PTBT and Control conditions.||||
73965389|NCT05644002|147465944|OTHER||Mean Difference (Final Values)|-0.698||||0.77|TWO_SIDED|95.0|-5.443|4.046||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.||4.046|-5.443|.77
73965390|NCT05644002|147465944|OTHER||t-statistic|-0.294|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction Pmax between the PTBT and Control conditions.||||
73965391|NCT05644002|147465944|OTHER||Hedge's g|-0.071|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.||||
73965392|NCT05644002|147465945|OTHER||Mean Difference (Final Values)|-0.354||||0.9|TWO_SIDED|95.0|-6.009|5.3||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.||5.300|-6.009|.90
73965393|NCT05644002|147465945|OTHER||t-statistic|-0.125|||||TWO_SIDED||||||t-test, 2 sided|degrees of freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction breakpoint between the PTBT and Control conditions.||||
73965394|NCT05644002|147465945|OTHER||Hedge's g|-0.03|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.||||
73965395|NCT05644002|147465946|OTHER||Mean Difference (Final Values)|-0.748||||0.09|TWO_SIDED|95.0|-1.601|0.105||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.||.105|-1.601|.09
73913315|NCT01980940|147356503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.5|STANDARD_ERROR_OF_MEAN|8.53||0.2691|TWO_SIDED|90.0|-23.9|4.8|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||4.8|-23.9|0.2691
73913316|NCT01980940|147356503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|8.15||0.3246|TWO_SIDED|90.0|-21.8|5.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||5.6|-21.8|0.3246
73913317|NCT01980940|147356503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.19||0.3881|TWO_SIDED|90.0|-20.9|6.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||6.6|-20.9|0.3881
73913318|NCT01980940|147356504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.3|STANDARD_ERROR_OF_MEAN|68.25||0.4477|TWO_SIDED|90.0|-166.8|62.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||62.3|-166.8|0.4477
73913319|NCT01980940|147356504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.7|STANDARD_ERROR_OF_MEAN|65.42||0.6084|TWO_SIDED|90.0|-143.6|76.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||76.1|-143.6|0.6084
73913320|NCT01980940|147356504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.2|STANDARD_ERROR_OF_MEAN|65.25||0.5926|TWO_SIDED|90.0|-144.7|74.4|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||74.4|-144.7|0.5926
73913321|NCT01980940|147356504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.3|STANDARD_ERROR_OF_MEAN|62.49||0.5022|TWO_SIDED|90.0|-147.2|62.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||62.6|-147.2|0.5022
73913322|NCT01980940|147356504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.0|STANDARD_ERROR_OF_MEAN|63.7||0.5125|TWO_SIDED|90.0|-149.0|64.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||64.9|-149.0|0.5125
73965396|NCT05644002|147465946|OTHER||t-statistic|-1.75|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 65.261||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.||||
73913323|NCT01980940|147356505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2632|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 2 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.2632
73913324|NCT01980940|147356505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4703|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 4 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.4703
73913325|NCT01980940|147356505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5507|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 7 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.5507
73913326|NCT01980940|147356505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3992|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 11 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.3992
73913327|NCT01980940|147356505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6626|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 14 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.6626
73913328|NCT01980940|147356505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.315|||||||Jonckheere-Terpstra test|||Treatment comparison of post-trial PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.3150
73913329|NCT01637935|147356531|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1||||||95.0|0.92|1.31||||||Fully adjusted refers to inclusion of all potential confounders in the statistical model from the 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder cancer, renal insufficiency, HbA1c and the interaction with new diagnosis of diabetes, duration of diabetes, and year of cohort entry.||1.31|0.92|
73913330|NCT01637935|147356531|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.06||||||95.0|0.89|1.26||||||Fully adjusted adding the proteinuria testing variable.||1.26|0.89|
74085659|NCT01976728|147725590|SUPERIORITY|||||||0.1088||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1088
73913331|NCT01637935|147356532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||||95.0|0.71|1.12||||||Time since starting pioglitazone \<4.5 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.12|0.71|
73965397|NCT05644002|147465946|OTHER||Hedge's g|-0.405|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ craving reduction between the PTBT and Control conditions.||||
74085660|NCT01976728|147725590|SUPERIORITY|||||||0.2374||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2374
73913332|NCT01637935|147356532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||||95.0|0.93|1.59||||||Time since starting pioglitazone 4.5-8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.59|0.93|
73913333|NCT01637935|147356532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||||95.0|0.83|1.75||||||Time since starting pioglitazone \>8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.75|0.83|
73913334|NCT01637935|147356533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||||95.0|0.68|1.16||||||Duration of therapy \<1.5 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.16|0.68|
73913335|NCT01637935|147356533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||||95.0|0.8|1.33||||||Duration of therapy 1.5-4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.33|0.80|
74085661|NCT01976728|147725590|SUPERIORITY|||||||0.0796||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test||||0.0796
73913336|NCT01637935|147356533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||||95.0|0.87|1.54||||||Duration of therapy \>4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.54|0.87|
73913337|NCT01637935|147356534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.69|1.16||||||Cumulative dose 1-14000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.16|0.69|
73913338|NCT01637935|147356534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||||95.0|0.85|1.42||||||Cumulative dose 14001-40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.42|0.85|
73965398|NCT05644002|147465947|OTHER||Mean Difference (Final Values)|0.184||||0.666|TWO_SIDED|95.0|-0.663|1.031||The threshold for statistical significance was p\<.05|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.||1.031|-.663|.666
73965399|NCT05644002|147465947|OTHER||t-statistic|0.184|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 73||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.||||
73965400|NCT05644002|147465947|OTHER||Hedge's g|0.099|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ psychological reward between the PTBT and Control conditions.||||
74085662|NCT01976728|147725590|SUPERIORITY|||||||0.1757||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test||||0.1757
73913339|NCT01637935|147356534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||||95.0|0.79|1.44||||||Cumulative dose \>40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.44|0.79|
73913340|NCT00709761|147356536|SUPERIORITY_OR_OTHER||percentage of participants|53.0||||||95.0|40.7|66.0|||||The estimation parameter represents the percentage of participants experiencing either a CR or a PR.|||66.0|40.7|
73913341|NCT01918774|147356542|OTHER|Pre-post analysis comparing weeks worked in the 6 months preceding baseline and the 6 month study follow-up.|||||<|0.001||||||A priori threshold of significance was p\<.05|within groups t-test|||||||<.001
74085663|NCT01976728|147725590|SUPERIORITY|||||||0.0584||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0584
73913342|NCT01687998|147356555|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.006||||0.9054|TWO_SIDED|95.0|0.911|1.111|||Regression, Cox|||Primary Endpoint: Time to First Occurrence of the Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)||1.111|0.911|0.9054
73913343|NCT01687998|147356556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.11|||<|0.0001|TWO_SIDED|95.0|-38.15|-36.08|||ANOVA|||LDL-C||-36.08|-38.15|<0.0001
73913344|NCT01687998|147356556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|131.55|||<|0.0001|TWO_SIDED|95.0|130.01|133.09|||ANOVA|||HDL-C||133.09|130.01|<0.0001
74085664|NCT01976728|147725590|SUPERIORITY|||||||0.3711||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3711
73913345|NCT01687998|147356557|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.991||||0.8463|TWO_SIDED|95.0|0.901|1.089|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA||1.089|0.901|0.8463
73913346|NCT01687998|147356558|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.001||||0.9874|TWO_SIDED|95.0|0.901|1.112|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization||1.112|0.901|0.9874
73913347|NCT01687998|147356559|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.003||||0.9574|TWO_SIDED|95.0|0.893|1.127|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA||1.127|0.893|0.9574
73913348|NCT01687998|147356560|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.965||||0.5917|TWO_SIDED|95.0|0.846|1.1|||Regression, Cox|||Time to First Occurrence of Triple Composite Endpoint of CV Death, MI, or Stroke||1.100|0.846|0.5917
73913349|NCT01135420|147356563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
74085665|NCT01976728|147725590|SUPERIORITY|||||||0.0143||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0143
74085666|NCT01976728|147725590|SUPERIORITY|||||||0.006||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0060
73913350|NCT00717197|147356570|SUPERIORITY_OR_OTHER||Percentage|21.7|STANDARD_ERROR_OF_MEAN|7.27|||TWO_SIDED|95.0|7.46|43.7||||||||43.7|7.46|
73913351|NCT03003390|147356591|SUPERIORITY||Posterior probabilities|0.09|||||TWO_SIDED||||||||||Using informative priors of B(1, 1) on the enoxaparin arm and B(18, 82) on the usual care arm, the risks of CADVT were 0.32 (95% CrI: 0.16, 0.51) in the enoxaparin arm and 0.25 (95% CrI: 0.18, 0.33) in the usual care arm. The posterior probability that the absolute difference in the risk of CADVT was lower by 0.06 in the enoxaparin arm was 9.1%. Using minimally informative priors, the risk ratio of CADVT with enoxaparin was 0.55 (95% CrI: 0.24, 1.11).|||
73913352|NCT03003390|147356592|SUPERIORITY|||||||0.22|||||||Linear mixed effects model|||||||0.22
73913353|NCT03003390|147356593|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73913354|NCT03003390|147356594|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
73913355|NCT03003390|147356595|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
73913356|NCT03003390|147356596|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73913357|NCT03003390|147356598|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
73913358|NCT03311724|147356604|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Mixed Models Analysis|||||-1.4|-2.5|<0.001
73913359|NCT03311724|147356604|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-2.8|-1.7|||Mixed Models Analysis|||||-1.7|-2.8|<0.001
73913360|NCT03311724|147356604|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Mixed Models Analysis|||||-1.4|-2.5|<0.001
73913361|NCT03311724|147356605|SUPERIORITY||Odds Ratio (OR)|56.54|||<|0.001|TWO_SIDED|95.0|9.43|338.97|||Regression, Logistic|||||338.97|9.43|<0.001
73913362|NCT03311724|147356605|SUPERIORITY||Odds Ratio (OR)|183.48|||<|0.001|TWO_SIDED|95.0|22.0|999.0|||Regression, Logistic||"Maximum confidential interval is \>999"|||999|22.0|<0.001
73913363|NCT03311724|147356605|SUPERIORITY||Odds Ratio (OR)|157.54|||<|0.001|TWO_SIDED|95.0|21.63|999.0|||Regression, Logistic||"Maximum confidential interval is \>999"|||999|21.63|<0.001
73913364|NCT03311724|147356606|SUPERIORITY||Mean Difference (Final Values)|-48.5|||<|0.001|TWO_SIDED|95.0|-70.6|-26.3|||Mixed Models Analysis|||||-26.3|-70.6|<0.001
73913365|NCT03311724|147356606|SUPERIORITY||Mean Difference (Final Values)|-58.0|||<|0.001|TWO_SIDED|95.0|-80.7|-35.2|||Mixed Models Analysis|||||-35.2|-80.7|<0.001
73913366|NCT03311724|147356606|SUPERIORITY||Mean Difference (Final Values)|-61.9|||<|0.001|TWO_SIDED|95.0|-84.6|-39.2|||Mixed Models Analysis|||||-39.2|-84.6|<0.001
73913367|NCT03311724|147356607|SUPERIORITY||Mean Difference (Final Values)|-4.8|||<|0.001|TWO_SIDED|95.0|-7.1|-2.6|||Mixed Models Analysis|||||-2.6|-7.1|<0.001
73913368|NCT03311724|147356607|SUPERIORITY||Mean Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-7.2|-2.7|||Mixed Models Analysis|||||-2.7|-7.2|<0.001
73913369|NCT03311724|147356607|SUPERIORITY||Mean Difference (Final Values)|-5.2|||<|0.001|TWO_SIDED|95.0|-7.5|-2.9|||Mixed Models Analysis|||||-2.9|-7.5|<0.001
73913370|NCT03311724|147356608|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.075|TWO_SIDED|95.0|-4.7|0.2|||Mixed Models Analysis|||||0.2|-4.7|0.075
73913371|NCT03311724|147356608|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.065|TWO_SIDED|95.0|-4.9|0.1|||Mixed Models Analysis|||||0.1|-4.9|0.065
73913372|NCT03311724|147356608|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.065|TWO_SIDED|95.0|-4.9|0.2|||Mixed Models Analysis|||||0.2|-4.9|0.065
73913373|NCT01749137|147356619|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.059|TWO_SIDED|95.0|-2.27|0.04|||Mixed Model Repeated Measures (MMRM)|||||0.04|-2.27|0.059
73913374|NCT01749137|147356620|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.66||0.079|TWO_SIDED|95.0|-2.48|0.14|||MMRM|||||0.14|-2.48|0.079
73913375|NCT01749137|147356621|SUPERIORITY|||||||0.513||||||P-values from a Cochran-Mantel-Haenszel (CMH) test, controlling for site and the stratification factor severely obese (yes/no).|Cochran-Mantel-Haenszel|||||||0.513
73913376|NCT01749137|147356629|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.87||0.387|TWO_SIDED|95.0|-2.5|0.98|||MMRM|||||0.98|-2.50|0.387
73913377|NCT01749137|147356630|SUPERIORITY|||||||1||||||P-values from a Cochran-Mantel-Haenszel (CMH) test, controlling for site.|Cochran-Mantel-Haenszel|||||||1.000
73913378|NCT01758432|147356631|SUPERIORITY||Least Squares Means (Difference)|-95.74|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913379|NCT01758432|147356631|SUPERIORITY||Least Squares Means (Difference)|-130.5|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913380|NCT01758432|147356631|SUPERIORITY||Least Squares Means (Difference)|-129.86|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73965401|NCT05644002|147465948|OTHER||β|0.026||||0.73|TWO_SIDED|95.0|-0.358|0.507||The threshold for statistical significance was p\<.05.|Regression, Linear|Coding: Control=0, PTBT=1.||A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress-induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrhythmia at step 1 of the model.||.507|-.358|.73
73913381|NCT01758432|147356631|SUPERIORITY||Least Squares Means (Difference)|-165.91|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913382|NCT01758432|147356631|SUPERIORITY||Least Squares Means (Difference)|-167.94|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913383|NCT01758432|147356631|SUPERIORITY||Least Squares Means (Difference)|-135.91|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913384|NCT01758432|147356632|SUPERIORITY||Least Squares Means (Difference)|85559.49||||0.0004|TWO_SIDED|95.0|||||ANCOVA|||||||0.0004
73913385|NCT01758432|147356632|SUPERIORITY||Least Squares Means (Difference)|105508.3|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913386|NCT01758432|147356632|SUPERIORITY||Least Squares Means (Difference)|182753.2|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913387|NCT01758432|147356632|SUPERIORITY||Least Squares Means (Difference)|193684.5|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913388|NCT01758432|147356632|SUPERIORITY||Least Squares Means (Difference)|178055.0|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913389|NCT01758432|147356632|SUPERIORITY||Least Squares Means (Difference)|169709.9|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913390|NCT01758432|147356633|SUPERIORITY||Least Squares Means (Difference)|-4.58|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913391|NCT01758432|147356633|SUPERIORITY||Least Squares Means (Difference)|-4.29|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913392|NCT01758432|147356633|SUPERIORITY||Least Squares Means (Difference)|-6.15|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913393|NCT01758432|147356633|SUPERIORITY||Least Squares Means (Difference)|-6.79|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913394|NCT01758432|147356633|SUPERIORITY||Least Squares Means (Difference)|-7.49|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913395|NCT01758432|147356633|SUPERIORITY||Least Squares Means (Difference)|-6.71|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
73913396|NCT00621985|147356640|SUPERIORITY_OR_OTHER||Percent Difference|-19.0||||0.09||95.0|||||t-test, 2 sided|||"A t-test was performed comparing the mean long transformed area under the curve of 17-hydroxyprogesterone between the dexamethasone and hydrocortisone arms. The percent difference in mean log AUC was calculated as:~(Mean log AUC on dexamethasone - Mean log AUC on hydrocortisone)/Mean log AUC on hydrocortisone"||||0.09
73913397|NCT00706823|147356648|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
73913398|NCT00706823|147356649|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Fisher Exact|||||||0.22
73913399|NCT00706823|147356651|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
73913400|NCT00706823|147356653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.11||||0.03|TWO_SIDED|95.0|1.1|58.6|||Regression, Logistic|||||58.6|1.1|0.03
73965402|NCT05644002|147465948|OTHER||t-statistic|0.345|||||TWO_SIDED||||||Regression, Linear|degrees freedom = (2, 73)|Condition (0=control; 1=PTBT)|A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrythmia at step 1 of the model.||||
73913401|NCT01144286|147356655|SUPERIORITY_OR_OTHER||response rate (%)|80.0||||0.063|TWO_SIDED|95.0||||Significance level was set to α of 0.05 if the primary endpoint was significant, hierarchical testing was to be performed on the primary endpoint (each active dose X placebo). No other adjustment was made for testing multiple secondary outcomes.|Regression, Logistic|||"Primary analysis is the dose response at TOC based on the global therapeutic cure. Dose response will be tested using a logistic regression using linear coefficient for the treatment effect(Wald chi-square).~Assuming that the response rate is 80% for 600 mg, 75% for the 300 mg, 65% for 150 mg and 50% for the placebo group, a sample size of 45 subjects in each group will have 90% power to detect a linear dose response using a 0.05 two-sided test of trend based on the logistic model."||||0.0630
73913402|NCT03535844|147356658|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|independent t-test of change values||||||0.49
73913403|NCT03535844|147356658|SUPERIORITY|||||||0.5672|||||||t-test, 1 sided|Paired t-test (Week 0 and Week 16)||||||0.5672
73913404|NCT03535844|147356658|SUPERIORITY|||||||0.788|||||||t-test, 2 sided|Paired t-test of change values||||||0.788
73913405|NCT03535844|147356659|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|independent t-test of change values||||||0.67
73913406|NCT03535844|147356659|SUPERIORITY|||||||0.8203|||||||t-test, 2 sided|Paired t-test of change values||||||0.8203
73913407|NCT03535844|147356659|SUPERIORITY|||||||0.3882|||||||t-test, 2 sided|Paired t-test of change values||||||0.3882
73913408|NCT03535844|147356660|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|independent t-test of change values||||||0.08
73913409|NCT03535844|147356661|SUPERIORITY|||||||0.7162|||||||t-test, 2 sided|independent t-test of change values||||||0.7162
73913410|NCT03535844|147356661|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values||||||0.07
73913411|NCT03535844|147356661|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values||||||<0.05
73913412|NCT03535844|147356662|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Independent t-test of change values||||||<0.05
73965403|NCT05644002|147465949|OTHER||Mean Difference (Final Values)|-0.543||||0.001|TWO_SIDED|95.0|-0.772|-0.314||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \< .05, equal variances are not assumed and reported results are adjusted accordingly.||An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.||-.314|-.772|.001
73965404|NCT05644002|147465949|OTHER||t-statistic|-4.739|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66.03||An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.||||
73965405|NCT05644002|147465949|OTHER||Hedge's g|-1.05|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction average puff duration between the PTBT and Control conditions.||||
73965406|NCT03821844|147465999|SUPERIORITY||marginal interaction effect|1.33|STANDARD_ERROR_OF_MEAN|1.38|<|0.05|TWO_SIDED|95.0|-1.37|4.03|||Differences-in-Differences regression||||"Fixed effects: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Scale (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual."|4.03|-1.37|< 0.05
73913413|NCT03535844|147356663|SUPERIORITY|||||||0.4855|||||||t-test, 2 sided|Independent t-test of change triglyceride values||||||0.4855
73913414|NCT03535844|147356663|SUPERIORITY|||||||0.1393|||||||t-test, 2 sided|Independent t-test of change total cholesterol values||||||0.1393
73913415|NCT03535844|147356663|SUPERIORITY|||||||0.2221|||||||t-test, 2 sided|Independent t-test of change LDL cholesterol values||||||0.2221
73913416|NCT03535844|147356663|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|Independent t-test of change HDL cholesterol values||||||0.078
73913417|NCT03535844|147356663|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values||||||<0.05
73913418|NCT03535844|147356663|SUPERIORITY|||||||0.7261|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values||||||0.7261
73913419|NCT03535844|147356664|SUPERIORITY|||||||0.1951|||||||t-test, 2 sided|Independent t-test of systolic blood pressure change values||||||0.1951
73913420|NCT03535844|147356664|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|Independent t-test of diastolic blood pressure change values||||||0.916
73913421|NCT03535844|147356665|SUPERIORITY|||||||0.9882|||||||t-test, 2 sided|independent t-test of malondialdehyde change values||||||0.9882
73913422|NCT03535844|147356666|SUPERIORITY|||||||0.4408|||||||t-test, 2 sided|Independent t-test of body fat % change values||||||0.4408
73913423|NCT03535844|147356667|SUPERIORITY|||||||0.1487|||||||t-test, 2 sided|Independent t-test of change values||||||0.1487
73913424|NCT03535844|147356668|SUPERIORITY|||||||0.9135|||||||t-test, 2 sided|Independent t-test of change values||||||0.9135
73913425|NCT03535844|147356669|SUPERIORITY|||||||0.5859|||||||t-test, 2 sided|Independent t-test of change values||||||0.5859
73913426|NCT03535844|147356670|SUPERIORITY|||||||0.9379|||||||t-test, 2 sided|Independent t-test of change values||||||0.9379
73913427|NCT03535844|147356671|SUPERIORITY|||||||0.9717|||||||t-test, 2 sided|t-test of change values||||||0.9717
73913428|NCT03535844|147356674|SUPERIORITY|||||||0.7052|||||||t-test, 2 sided|Independent t-test of change values||||||0.7052
73913429|NCT03535844|147356674|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|Paired t-test between Week 0 and Week 16 endothelin-1 concentrations||||||0.07
73913430|NCT03535844|147356674|SUPERIORITY|||||||0.005||||||Paired t-test between Week 0 and Week 16 endothelin-1 concentrations|t-test, 2 sided|||||||0.005
73913431|NCT03535844|147356675|SUPERIORITY|||||||0.9426||||||Independent t-test of change values|t-test, 2 sided|||||||0.9426
73913432|NCT03130257|147356676|EQUIVALENCE|The study planned for a sample size of 510 and 80% protocol completion, resulting in sample size 136 per group. With this sample size, the least detectable difference (LDD) is 4.1 mmHg systolic BP (SBP) and 2.8 mmHg diastolic BP (DBP) between any two groups (assuming Standard Deviation 12.1 and 8.3 for SBP and DBP respectively). Actual sample sizes completing protocol were 142, 149, and 111 for Clinic, Home, and Kiosk groups respectively, resulting in LDD of at least 4.3 for SBP and 3.0 for DBP.|||||<|0.05|||||||Regression, Linear|||We used linear regression models to estimate the mean difference in BP between diagnostic measurement and daytime average 24-hr BP for each randomization group. Models were estimated using generalized estimating equations with robust standard errors, and adjusted for age, sex, BMI, education, and baseline systolic and diastolic BP. Separate models estimated mean differences (diagnostic protocol - 24-hr BP) between groups for systolic and diastolic BP.||||<0.05
73913433|NCT01847274|147356709|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.173|0.41||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.410|0.173|<0.0001
73913434|NCT01847274|147356710|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.243|0.586||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.586|0.243|<0.0001
73913435|NCT01847274|147356711|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.338|0.607||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.607|0.338|<0.0001
73913436|NCT01847274|147356712|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0005|TWO_SIDED|95.0|0.412|0.783||Two-sided p-value|Log Rank|||||0.783|0.412|0.0005
73913437|NCT01847274|147356713|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.454|0.74||Two-sided P-value.|Log Rank|||||0.740|0.454|<0.0001
73913438|NCT01847274|147356714|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.268|0.561||Two-sided P-value.|Log Rank|||||0.561|0.268|<0.0001
74085667|NCT01976728|147725590|SUPERIORITY|||||||0.1573||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1573
73913439|NCT01847274|147356715|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.428|0.727||Two-sided P-value.|Log Rank|||||0.727|0.428|<0.0001
73913440|NCT01847274|147356716|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0302|TWO_SIDED|95.0|0.5|0.968||Two-sided P-value.|Log Rank|||||0.968|0.500|0.0302
73965407|NCT03821844|147466000|SUPERIORITY||marginal interaction effect|0.06|||<|0.05|TWO_SIDED|95.0|0.03|0.09|||Differences-in-Differences regression||Reported estimation details pertain to the None category.||"The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models. All models adjust for resident baseline covariates, an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. The reference category for the multinomial model for each outcome is None. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction."|0.09|0.03|< 0.05
73971312|NCT03785964|147483158|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline DEsmoid Tumor Symptom Scale score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 32 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
73913441|NCT01847274|147356717|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0748|TWO_SIDED|95.0|0.627|1.022||Two-sided P-value.|Log Rank|||||1.022|0.627|0.0748
73913442|NCT01847274|147356718|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.358|TWO_SIDED|95.0|0.606|1.198||Two-sided P-value.|Log Rank|||||1.198|0.606|0.3580
73913443|NCT01847274|147356719|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6868|TWO_SIDED|95.0|0.813|1.369||Two-sided P-value.|Log Rank|||||1.369|0.813|0.6868
73913444|NCT01847274|147356720|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0061|TWO_SIDED|95.0|0.451|0.878||Two-sided P-value.|Log Rank|||||0.878|0.451|0.0061
73913445|NCT01847274|147356721|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1674|TWO_SIDED|95.0|0.654|1.077||Two-sided P-value.|Log Rank|||||1.077|0.654|0.1674
73913446|NCT01847274|147356738|SUPERIORITY|||||||0.7969|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.7969
73913447|NCT01847274|147356738|SUPERIORITY|||||||0.8794|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.8794
73913448|NCT01847274|147356739|SUPERIORITY|||||||0.2399|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.2399
73913449|NCT01847274|147356739|SUPERIORITY|||||||0.4584|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.4584
73913450|NCT01847274|147356740|SUPERIORITY|||||||0.8566|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.8566
74085668|NCT01976728|147725591|SUPERIORITY|||||||0.4142||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4142
74085669|NCT01976728|147725591|SUPERIORITY|||||||0.2374||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2374
73913451|NCT01847274|147356740|SUPERIORITY|||||||0.4705|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.4705
73913452|NCT01847274|147356741|SUPERIORITY|||||||0.8521|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.8521
73913453|NCT01847274|147356741|SUPERIORITY|||||||0.9923|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.9923
73913454|NCT01847274|147356742|SUPERIORITY|||||||0.9997|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.9997
73913455|NCT01847274|147356742|SUPERIORITY|||||||0.3518|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.3518
73913456|NCT01847274|147356743|SUPERIORITY|||||||0.9367|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.9367
73913457|NCT01847274|147356743|SUPERIORITY|||||||0.2502|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2502
73913458|NCT01847274|147356744|SUPERIORITY|||||||0.5037|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.5037
73965408|NCT03821844|147466001|SUPERIORITY||Marginal Interaction Effect|-0.11|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED|95.0|-0.3|0.08|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, nursing home corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Score (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual."|0.08|-0.30|< 0.05
73965409|NCT03821844|147466002|SUPERIORITY||average marginal effect|-3.61|STANDARD_ERROR_OF_MEAN|1.85|<|0.05|TWO_SIDED|95.0|-7.22|0.0|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|0.00|-7.22|< 0.05
73965410|NCT03821844|147466003|SUPERIORITY||average marginal effect|-3.47|STANDARD_ERROR_OF_MEAN|2.08|<|0.05|TWO_SIDED|95.0|-7.55|0.06|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|0.06|-7.55|< 0.05
74085670|NCT01976728|147725591|SUPERIORITY|||||||0.2636||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2636
74085671|NCT01976728|147725591|SUPERIORITY|||||||0.4795||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4795
73913459|NCT01847274|147356744|SUPERIORITY|||||||0.164|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.1640
73913460|NCT01847274|147356745|SUPERIORITY|||||||0.9599|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.9599
73913461|NCT01847274|147356745|SUPERIORITY|||||||0.247|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2470
73913462|NCT01847274|147356746|SUPERIORITY|||||||0.5921|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.5921
73913463|NCT01847274|147356746|SUPERIORITY|||||||0.7459|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.7459
73913464|NCT01847274|147356747|SUPERIORITY|||||||0.0259|||||||Pearson's Chi-squared test|||||||0.0259
73913465|NCT01847274|147356747|SUPERIORITY|||||||0.2798|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2798
73913466|NCT01847274|147356754|SUPERIORITY||Ratio of Least square mean|1.1|||||TWO_SIDED|90.0|0.997|1.216||||||||1.216|0.997|
73913467|NCT01847274|147356755|SUPERIORITY||Ratio of Least square mean|1.068|||||TWO_SIDED|90.0|0.978|1.166||||||||1.166|0.978|
73913468|NCT01847274|147356756|SUPERIORITY||Ratio of Least square mean|0.785|||||TWO_SIDED|90.0|0.695|0.886||||||||0.886|0.695|
73913469|NCT03727230|147356760|OTHER||||||<|0.001|||||||Chi-squared|||In this study, a single-arm clinical trial was conducted. The summarized alloanti-D rate (203/720, 28.2%; 95% CI, 19%-32%) in truly RhD-negative patients with similar mixed diseases after RhD+ RBC transfusion reported in the meta-analysis (Ji YL, et al. Vox Sang 2022; 117: 633-40) was used as the control for comparison with alloanti-D rate identified in Asian-type DEL patients after RhD+ RBC transfusion in the clinical trial.||||< 0.001
73913470|NCT04377620|147356772|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0292|TWO_SIDED|95.0|0.201|1.028|||Mixed Models Analysis|logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.||||1.028|0.201|0.0292
73913471|NCT04377620|147356772|SUPERIORITY||Odds Ratio (OR)|0.42||||0.028|TWO_SIDED|95.0|0.171|1.023|||Mixed Models Analysis|logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.||||1.023|0.171|0.0280
73913472|NCT02849678|147356786|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.148|||||||t-test, 1 sided|||||||0.148
73913473|NCT02849678|147356788|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.636|||||||t-test, 1 sided|||||||.636
73913474|NCT02849678|147356790|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.193||||||Hydromorphone consumption (mg) in Post-Anesthesia Care Unit (PACU)|t-test, 2 sided|||||||0.193
73913475|NCT02849678|147356790|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.635||||||Hydromorphone consumption (mg) in PACU versus at 24 hours versus 48 hours|ANOVA|||||||0.635
73965411|NCT03821844|147466004|SUPERIORITY||average marginal effect|-1.26|STANDARD_ERROR_OF_MEAN|2.05|<|0.05|TWO_SIDED|95.0|-5.28|2.76|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|2.76|-5.28|< 0.05
73965412|NCT03821844|147466006|SUPERIORITY||average marginal effect|-0.22|||<|0.05|TWO_SIDED|95.0|-1.14|0.7|||Differences-in-Differences regression||||Multilevel regression with covariates' adjustments was used to estimate the impact of the resident being in a treatment versus control nursing home on depressive symptoms.|0.70|-1.14|< 0.05
73965413|NCT03821844|147466007|SUPERIORITY||marginal interaction effect|0.0|||<|0.05|TWO_SIDED|95.0|-0.03|0.02|||Differences-in-Differences regression||Reported estimation details pertain to the None category.||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the behaviors of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction.|0.02|-0.03|< 0.05
73965414|NCT03821844|147466008|SUPERIORITY||marginal interaction effect|0.05|||<|0.05|TWO_SIDED|95.0|0.02|0.07|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.07|0.02|< 0.05
73965415|NCT03821844|147466009|SUPERIORITY||marginal interaction effect|-0.01|||<|0.05|TWO_SIDED|95.0|-0.03|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.01|-0.03|< 0.05
73965416|NCT03821844|147466010|SUPERIORITY||average marginal effect|-0.01|||<|0.05|TWO_SIDED|95.0|-0.04|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.01|-0.04|< 0.05
73913476|NCT02849678|147356791|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.063|||||||ANOVA|Local Anesthetic Consumption through para-vertebral catheters in PACU vs. at 24 hours vs. 48 hours||||||0.063
74026864|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.56|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.72|0.56|
73913477|NCT00289991|147356792|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a true success rate of 50% in voriconazole (Vori) treatment (Tx) group and 45% in itraconazole (Itra) Tx group, sample size of 232 subjects per group=90% power to demonstrate non-inferiority of Vori to Itra using pre-specified non-inferiority margin of -10%. Sample has at least 80% power to demonstrate superiority of Vori over Itra if true success rates for Vori and Itra are 57% and 44% respectively. Based on this, up to 500 subjects were to be enrolled to obtain 464 eligible subjects.|percent difference adjusted proportions|16.4|||||TWO_SIDED|95.0|7.7|25.1|||Difference in adjusted responder rates|Difference in adjusted responder rates using Fleiss method|Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.|"Non-inferiority inferred if lower limit of the 2-sided 95 percent (%) confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant does not include zero and is positive."||25.1|7.7|
73913478|NCT00289991|147356793|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority inferred if lower limit of the 2-sided 95% confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant does not include zero and is positive."|percent difference adjusted proportions|15.4|||||TWO_SIDED|95.0|6.6|24.2|||Difference in adjusted responder rates|Difference in adjusted responder rates using the Fleiss method.|Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.|||24.2|6.6|
73913479|NCT00289991|147356795|SUPERIORITY_OR_OTHER||difference in proportions: percent|-0.4||||0.7114|TWO_SIDED|95.0|-2.2|1.5|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 100; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.||1.5|-2.2|0.7114
74085672|NCT01976728|147725591|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
73965417|NCT03821844|147466011|SUPERIORITY||marginal interaction effect|0.01|||<|0.05|TWO_SIDED|95.0|-0.02|0.03|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.03|-0.02|< 0.05
73965418|NCT03821844|147466012|SUPERIORITY||marginal interaction effect|-0.02|||<|0.05|TWO_SIDED|95.0|-0.05|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment vs. control NH had on the behaviors and moods of NH residents. The models were implemented separately for each mood. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction. We will refer to this estimand as the marginal interaction effect (MIE), which is sometimes known as the Difference in Differences estimand.|0.01|-0.05|< 0.05
73965419|NCT04065048|147466013|OTHER|||||||0.469|||||||t-test, 2 sided|||||||0.469
73965420|NCT04065048|147466014|OTHER|||||||0.0093|||||||ANOVA|||||||0.0093
73965421|NCT04065048|147466016|OTHER|||||||0.2487|||||||Fisher Exact|||||||0.2487
73965422|NCT03899961|147466063|SUPERIORITY|Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval|Median Difference (Net)|0.0||||0.05|TWO_SIDED|95.0|-1.09|1.09||Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval|Median regression model for the change f|||Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval||1.09|-1.09|0.05
73965423|NCT05857644|147466067|OTHER||Geometric mean ratio|84.33|||||TWO_SIDED|90.0|50.94|139.59|||||Mild Hepatic Impairment versus No Hepatic Impairment|||139.59|50.94|
74026865|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.45|0.35|
73965424|NCT05857644|147466067|OTHER||Geometric mean ratio|90.89|||||TWO_SIDED|90.0|54.91|150.45|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||150.45|54.91|
73965425|NCT05857644|147466067|OTHER||Geometric mean ratio|157.23|||||TWO_SIDED|90.0|84.81|291.49|||||Severe Hepatic Impairment versus No Hepatic Impairment|||291.49|84.81|
73965426|NCT05857644|147466068|OTHER||Geometric mean ratio|82.17|||||TWO_SIDED|90.0|49.24|137.11|||||Mild Hepatic Impairment versus No Hepatic Impairment|||137.11|49.24|
73965427|NCT05857644|147466068|OTHER||Geometric mean ratio|130.82|||||TWO_SIDED|90.0|78.4|218.3|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||218.30|78.40|
73965428|NCT05857644|147466068|OTHER||Geometric mean ratio|385.52|||||TWO_SIDED|90.0|205.92|721.77|||||Severe Hepatic Impairment versus No Hepatic Impairment|||721.77|205.92|
73965429|NCT05857644|147466069|OTHER||Geometric mean ratio|82.99|||||TWO_SIDED|90.0|50.53|136.28|||||Mild Hepatic Impairment versus No Hepatic Impairment|||136.28|50.53|
73913480|NCT00289991|147356795|SUPERIORITY_OR_OTHER||difference in proportion: percent|-0.3||||0.7759|TWO_SIDED|95.0|-2.5|1.9|||Difference in proportions|Difference in proportions (approximate result).|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.||1.9|-2.5|0.7759
73913481|NCT00289991|147356796|SUPERIORITY_OR_OTHER||difference in proportions: percent|0.3|||||TWO_SIDED|95.0|-6.3|6.9|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95% confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||6.9|-6.3|
74085673|NCT01976728|147725591|SUPERIORITY|||||||0.3711||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3711
74085674|NCT01976728|147725591|SUPERIORITY|||||||0.4142||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4142
74085675|NCT01976728|147725591|SUPERIORITY|||||||0.0838||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0838
74085676|NCT01976728|147725591|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
74085677|NCT01976728|147725591|SUPERIORITY|||||||0.3778||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3778
74085678|NCT01976728|147725592|SUPERIORITY||Least square mean (LSM) difference|1.35||||0.6732|TWO_SIDED|95.0|-5.16|7.87||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% confidence interval (CI) for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 10 µg group were compared to placebo using an analysis of covariance (ANCOVA) model including the randomization scheme and treatment group as factors and baseline value as covariate.||7.87|-5.16|0.6732
74085679|NCT01976728|147725592|SUPERIORITY||LSM|5.7||||0.0814|TWO_SIDED|95.0|-0.76|12.15||p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.||12.15|-0.76|0.0814
74085680|NCT01976728|147725592|SUPERIORITY||LSM difference|7.55||||0.0223|TWO_SIDED|95.0|1.16|13.93||p-value for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||13.93|1.16|0.0223
73965430|NCT05857644|147466069|OTHER||Geometric mean ratio|131.52|||||TWO_SIDED|90.0|80.09|215.99|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||215.99|80.09|
74085681|NCT01976728|147725593|SUPERIORITY||LSM difference|0.679||||0.7355|TWO_SIDED|95.0|-3.404|4.762||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 10 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||4.762|-3.404|0.7355
74085682|NCT01976728|147725593|SUPERIORITY||LSM difference|2.602||||0.198|TWO_SIDED|95.0|-1.444|6.648||p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.||6.648|-1.444|0.1980
73913482|NCT00289991|147356797|SUPERIORITY_OR_OTHER|||||||0.0026||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon (Mann-Whitney)||Mann-Whitney test used to investigate the null hypothesis that the times to discontinuation of study medication in each treatment group come from the same distribution.||||0.0026
73965431|NCT05857644|147466069|OTHER||Geometric mean ratio|392.1|||||TWO_SIDED|90.0|213.57|719.85|||||Severe Hepatic Impairment versus No Hepatic Impairment|||719.85|213.57|
73965432|NCT05307978|147466090|SUPERIORITY||Ratio (%)|68.729|||||TWO_SIDED|95.0|52.74|89.56|||Mixed Models Analysis|A mixed effect model was performed to the ln-transformed PK parameter and the independent variables.||||89.56|52.74|
73913483|NCT00289991|147356798|SUPERIORITY_OR_OTHER||difference in proportions: percent|-4.8||||0.2487|TWO_SIDED|95.0|-13.0|3.4|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent % confidence interval for the difference in proportions.|Day 365; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||3.4|-13.0|0.2487
73965433|NCT05307978|147466091|SUPERIORITY||Ratio (%)|120.043|||||TWO_SIDED|95.0|67.2|214.43|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||214.43|67.20|
73965434|NCT05307978|147466092|SUPERIORITY||Ratio (%)|118.142|||||TWO_SIDED|95.0|73.93|188.8|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||188.80|73.93|
73965435|NCT05307978|147466093|SUPERIORITY||Ratio (%)|93.891|||||TWO_SIDED|95.0|63.17|139.56|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||139.56|63.17|
73965436|NCT05656911|147466102|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-5.0|||||TWO_SIDED|95.0|-29.0|18.0|||||Posterior probability is 34.0%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||18.0|-29.0|
73965437|NCT05656911|147466103|OTHER||Mean Difference (Final Values)|11.31||||0.257|TWO_SIDED|95.0|-8.26|30.87||two-sided. No adjustment for multiple comparisons.|ANCOVA||LS mean (%)|The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||30.87|-8.26|0.257
73965438|NCT05656911|147466104|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-27.0|22.1|||||Posterior probability is 41.7%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||22.1|-27.0|
73965439|NCT05656911|147466105|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-4.6|||||TWO_SIDED|95.0|-25.6|13.4|||||Posterior probability is 31.5%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||13.4|-25.6|
73965440|NCT05656911|147466106|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-12.5|||||TWO_SIDED|95.0|-34.1|7.0|||||Posterior probability is 10.8%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||7.0|-34.1|
73965441|NCT05656911|147466107|OTHER||Mean Difference (Final Values)|7.06||||0.166|TWO_SIDED|95.0|-2.92|17.03||two-sided. No adjustment for multiple comparisons.|ANCOVA|||The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||17.03|-2.92|0.166
74088364|NCT03694808|147730158|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.136|||||TWO_SIDED|95.0|-0.019|0.291|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.291|-0.019|
73965442|NCT05656911|147466108|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-8.4|||||TWO_SIDED|95.0|-30.4|11.0|||||Posterior probability is 20.5%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||11.0|-30.4|
73965443|NCT05656911|147466110|OTHER||Mean Difference (Final Values)|6.68||||0.396|TWO_SIDED|95.0|-8.75|22.11||two-sided. No adjustment for multiple comparisons.|ANCOVA|||The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||22.11|-8.75|0.396
73965444|NCT05075408|147466112|SUPERIORITY|Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.|Strata adjusted percentage difference|7.0||||0.3696|TWO_SIDED|97.5|-10.6|24.6||Threshold of significance at 0.025.|Cochran-Mantel-Haenszel|||Nemolizumab 30 mg versus Placebo||24.6|-10.6|0.3696
73965445|NCT05075408|147466112|SUPERIORITY|Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.|Strata adjusted percentage difference|14.5||||0.0686|TWO_SIDED|97.5|-3.1|32.2||Threshold of significance at 0.025.|Cochran-Mantel-Haenszel|||Nemolizumab 60 mg versus Placebo||32.2|-3.1|0.0686
73965446|NCT05075408|147466113|SUPERIORITY||Strata adjusted percentage difference|4.3||||0.5909|TWO_SIDED|97.5|-13.8|22.3|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||22.3|-13.8|0.5909
73965447|NCT05075408|147466113|SUPERIORITY||Strata adjusted percentage difference|12.9||||0.1112|TWO_SIDED|97.5|-5.5|31.4|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||31.4|-5.5|0.1112
73965448|NCT05075408|147466114|SUPERIORITY||Strata adjusted percentage difference|17.3||||0.0034|TWO_SIDED|97.5|4.3|30.4|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||30.4|4.3|0.0034
73965449|NCT05075408|147466114|SUPERIORITY||Strata adjusted percentage difference|17.1||||0.0025|TWO_SIDED|97.5|4.5|29.8|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||29.8|4.5|0.0025
73913484|NCT00289991|147356800|SUPERIORITY_OR_OTHER||difference in proportions: percent|-8.8||||0.057|TWO_SIDED|95.0|-17.8|0.3|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95% confidence interval for the difference in proportions.|Difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||0.3|-17.8|0.0570
73913485|NCT01606007|147356804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.1112|<|0.0001|TWO_SIDED|95.0|-0.81|-0.37||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis|||||-0.37|-0.81|<0.0001
73913486|NCT01606007|147356804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.1108||0.0166|TWO_SIDED|95.0|-0.48|-0.05||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis|||||-0.05|-0.48|0.0166
73913487|NCT01606007|147356805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.0|STANDARD_ERROR_OF_MEAN|4.914|<|0.0001|TWO_SIDED|95.0|-53.7|-34.3||Each secondary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|ANCOVA|||LOCF||-34.3|-53.7|<0.0001
73913488|NCT01606007|147356805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|STANDARD_ERROR_OF_MEAN|4.923||0.0639|TWO_SIDED|95.0|-18.8|0.5||Each secondary endpoint was tested at alpha=0.05; significance testing stops at the endpoint where p-value\>0.05.|ANCOVA|||LOCF||0.5|-18.8|0.0639
73913489|NCT01606007|147356806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8|STANDARD_ERROR_OF_MEAN|3.988|||TWO_SIDED|95.0|-31.6|-15.9|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||-15.9|-31.6|
73913490|NCT01606007|147356806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|3.957|||TWO_SIDED|95.0|-13.8|1.7|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||1.7|-13.8|
73913491|NCT01606007|147356807|SUPERIORITY_OR_OTHER||Mean difference in percentages|23.1|STANDARD_ERROR_OF_MEAN|4.282|||TWO_SIDED|95.0|14.7|31.5|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||31.5|14.7|
73913492|NCT01606007|147356807|SUPERIORITY_OR_OTHER||Mean difference in percentages|19.1|STANDARD_ERROR_OF_MEAN|4.587|||TWO_SIDED|95.0|10.1|28.1|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||28.1|10.1|
73913493|NCT01606007|147356808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|0.3451|||TWO_SIDED|95.0|-2.73|-1.37|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||-1.37|-2.73|
73913494|NCT03706079|147356809|SUPERIORITY||Rate Ratio|0.42|||||TWO_SIDED|95.0|0.35|0.51||||||||0.51|0.35|
73965450|NCT05075408|147466115|SUPERIORITY||Strata adjusted percentage difference|3.7||||0.5788|TWO_SIDED|97.5|-12.5|19.8|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||19.8|-12.5|0.5788
73965451|NCT05075408|147466115|SUPERIORITY||Strata adjusted percentage difference|16.5||||0.0303|TWO_SIDED|97.5|-0.8|33.9|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||33.9|-0.8|0.0303
73965452|NCT05075408|147466116|SUPERIORITY||Strata adjusted percentage difference|24.2||||0.0006|TWO_SIDED|97.5|8.8|39.6|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||39.6|8.8|0.0006
74088365|NCT03694808|147730158|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.024|||||TWO_SIDED|95.0|-0.117|0.164|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.164|-0.117|
73913495|NCT03706079|147356809|SUPERIORITY||Rate Ratio|0.61|||||TWO_SIDED|95.0|0.38|0.96||||||||0.96|0.38|
73913496|NCT01203098|147356834|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.3|||||TWO_SIDED|95.0|-7.2|4.6||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.||4.6|-7.2|
73913497|NCT01203098|147356834|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|-4.6|6.8||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.||6.8|-4.6|
73965453|NCT05075408|147466116|SUPERIORITY||Strata adjusted percentage difference|20.8||||0.0021|TWO_SIDED|97.5|6.0|35.7|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||35.7|6.0|0.0021
73965454|NCT05075408|147466117|SUPERIORITY||Strata adjusted percentage difference|14.0||||0.0028|TWO_SIDED|97.5|3.8|24.1|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||24.1|3.8|0.0028
73913498|NCT00730405|147356836|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913499|NCT00730405|147356836|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73965455|NCT05075408|147466117|SUPERIORITY||Strata adjusted percentage difference|19.0||||0.0003|TWO_SIDED|97.5|7.6|30.5|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||30.5|7.6|0.0003
73965456|NCT02058108|147466147|OTHER|Missing assessment imputed using the closest available assessment|Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-37.03|36.75|||Fisher Exact|||HBV DNA level of \<300 copies/mL (51 IU/mL) at Week 24|Exact confidence interval for the difference in percentage|36.75|-37.03|1.0000
73965457|NCT02058108|147466149|OTHER||Mean Difference (Net)|32.43||||0.2984|TWO_SIDED|95.0|-14.62|74.6|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|ALT levels at Week 24||74.60|-14.62|0.2984
73965458|NCT02058108|147466150|OTHER||Mean Difference (Net)|2.7||||1|TWO_SIDED|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg loss at Week 24||60.20|-53.70|1.0000
73965459|NCT02058108|147466150|OTHER||Mean Difference (Net)|2.7||||1|TWO_SIDED|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg seroconversion at Week 24||60.20|-53.70|1.0000
73965460|NCT02058108|147466151|OTHER||Mean Difference (Net)|2.44||||1|TWO_SIDED|95.0|-37.54|42.17|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBsAg loss at Week 24||42.17|-37.54|1.0000
73913500|NCT00730405|147356836|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913501|NCT00730405|147356836|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913502|NCT00730405|147356837|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913503|NCT00730405|147356837|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913504|NCT00730405|147356837|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913505|NCT00730405|147356837|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913506|NCT00730405|147356838|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913507|NCT00730405|147356838|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913508|NCT00730405|147356838|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913509|NCT00730405|147356838|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913510|NCT00730405|147356839|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913511|NCT00730405|147356839|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913512|NCT00730405|147356839|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913513|NCT00730405|147356839|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913514|NCT00730405|147356840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
73913515|NCT00730405|147356840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.71|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
73913516|NCT00730405|147356840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.44|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
73965461|NCT02058108|147466154|OTHER||Mean Difference (Net)|2.5||||1|TWO_SIDED|95.0|-37.05|41.83|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|Treatment emergent genotypic resistance at Week 24||41.83|-37.05|1.0000
73965462|NCT00818246|147466199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.94|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.||||<0.0001
73965463|NCT00818246|147466200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.605|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|||||||ANCOVA|||||||<0.001
74026866|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.57|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.57|0.44|
74026867|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.85|0.60|
74026868|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.63|0.97|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.97|0.63|
74026869|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.81|1.08|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.08|0.81|
73913517|NCT00730405|147356840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.22|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|||||||ANOVA|||||||<0.001
73913518|NCT00730405|147356841|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74088366|NCT03694808|147730159|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.43|||||TWO_SIDED|95.0|0.29|0.64|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||0.64|0.29|
73913519|NCT00730405|147356841|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913520|NCT00730405|147356841|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913521|NCT00730405|147356841|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73913522|NCT03851705|147356845|SUPERIORITY||Mean Difference (Final Values)|-1.68||||0.9047|TWO_SIDED|95.0|-29.19|25.83||The a priori threshold for statistical significance was \<0.05 (two-sided)|ANCOVA|||||25.83|-29.19|0.9047
73965464|NCT00818246|147466201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.||||<0.0001
73965465|NCT01619410|147466238|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73965466|NCT00999167|147466244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0354|TWO_SIDED|95.0|||||Poisson regression adjusting for country|||||||0.0354
73965467|NCT00999167|147466245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0214||95.0|||||Cochran-Mantel-Haenszel|||||||0.0214
73913523|NCT03851705|147356846|SUPERIORITY||Mean Difference (Final Values)|6.47||||0.8685|TWO_SIDED|95.0|-70.11|83.05||The a priori threshold for statistical significance was \<0.05 (two-sided)|ANCOVA|||||83.05|-70.11|0.8685
73913524|NCT03851705|147356847|SUPERIORITY||Mean Difference (Final Values)|-12.1||||0.2347|TWO_SIDED|95.0|-32.2|8.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.1|-32.2|0.2347
73913525|NCT03851705|147356847|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.7058|TWO_SIDED|95.0|-19.9|29.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||29.2|-19.9|0.7058
73965468|NCT00999167|147466246|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.047||95.0|||||Regression, Cox|||||||0.047
73913526|NCT03851705|147356847|SUPERIORITY||Mean Difference (Final Values)|-5.7||||0.5653|TWO_SIDED|95.0|-25.5|14.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||14.1|-25.5|0.5653
73913527|NCT03851705|147356849|SUPERIORITY||Mean Difference (Final Values)|-19.9||||0.4589|TWO_SIDED|95.0|-73.3|33.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||33.6|-73.3|0.4589
73913528|NCT03851705|147356849|SUPERIORITY||Mean Difference (Final Values)|17.7||||0.5956|TWO_SIDED|95.0|-48.8|84.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||84.3|-48.8|0.5956
73913529|NCT03851705|147356849|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.7861|TWO_SIDED|95.0|-62.7|47.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||47.7|-62.7|0.7861
73913530|NCT03851705|147356851|SUPERIORITY||Mean Difference (Final Values)|-62.6|||<|0.0001|TWO_SIDED|95.0|-80.1|-45.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||-45.1|-80.1|<.0001
73913531|NCT03851705|147356851|SUPERIORITY||Mean Difference (Final Values)|-60.6|||<|0.0001|TWO_SIDED|95.0|-83.5|-37.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-37.8|-83.5|<.0001
73913532|NCT03851705|147356851|SUPERIORITY||Mean Difference (Final Values)|-92.3|||<|0.0001|TWO_SIDED|95.0|-120.4|-64.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-64.2|-120.4|<.0001
73913533|NCT03851705|147356853|SUPERIORITY||Mean Difference (Final Values)|-316.6|||<|0.0001|TWO_SIDED|95.0|-420.7|-212.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||-212.6|-420.7|<.0001
73913534|NCT03851705|147356853|SUPERIORITY||Mean Difference (Final Values)|-304.4|||<|0.0001|TWO_SIDED|95.0|-408.0|-200.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-200.8|-408.0|<.0001
73965469|NCT00999167|147466247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0713|TWO_SIDED|95.0|||||ANCOVA|||Changes in the Total Index Score from Baseline and Day 56.||||0.0713
73965470|NCT00999167|147466247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.252|TWO_SIDED|95.0|||||ANCOVA|||Changes in the Total Index Score from Baseline and the Final Visit.||||0.2520
73965471|NCT02885636|147466248|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
73965472|NCT02885636|147466249|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
73965473|NCT02885636|147466250|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
73965474|NCT02885636|147466251|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.9
73965475|NCT02885636|147466252|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73965476|NCT02885636|147466253|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
73965477|NCT02885636|147466254|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
73965478|NCT02885636|147466255|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
73965479|NCT02885636|147466256|SUPERIORITY|||||||0.0007|||||||t-test, 2 sided|||||||0.0007
73965480|NCT02885636|147466257|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
73965481|NCT02885636|147466258|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
73965482|NCT02885636|147466259|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
73965483|NCT02885636|147466260|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
73965484|NCT02885636|147466261|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
74088367|NCT03694808|147730159|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.45|||||TWO_SIDED|95.0|0.29|0.69|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||0.69|0.29|
73913535|NCT03851705|147356853|SUPERIORITY||Mean Difference (Final Values)|-390.4|||<|0.0001|TWO_SIDED|95.0|-504.5|-276.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||-276.3|-504.5|<.0001
73913536|NCT03851705|147356855|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.3299|TWO_SIDED|95.0|-23.9|8.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.2|-23.9|0.3299
73913537|NCT03851705|147356855|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.7778|TWO_SIDED|95.0|-16.7|22.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||22.2|-16.7|0.7778
73913538|NCT03851705|147356855|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.6613|TWO_SIDED|95.0|-19.2|12.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||12.3|-19.2|0.6613
73913539|NCT03851705|147356856|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.4911|TWO_SIDED|95.0|-74.0|36.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||36.0|-74.0|0.4911
73913540|NCT03851705|147356856|SUPERIORITY||Mean Difference (Final Values)|11.1||||0.7461|TWO_SIDED|95.0|-57.2|79.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||79.4|-57.2|0.7461
73913541|NCT03851705|147356856|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.837|TWO_SIDED|95.0|-62.8|51.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||51.1|-62.8|0.8370
74026870|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.74|0.99|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.99|0.74|
73913542|NCT03851705|147356859|SUPERIORITY||Mean Difference (Final Values)|-12.7||||0.1371|TWO_SIDED|95.0|-29.5|4.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.2|-29.5|0.1371
73913543|NCT03851705|147356859|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.71|TWO_SIDED|95.0|-22.6|15.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||15.5|-22.6|0.7100
74026871|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
73913544|NCT03851705|147356859|SUPERIORITY||Mean Difference (Final Values)|-10.3||||0.2278|TWO_SIDED|95.0|-27.2|6.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||6.6|-27.2|0.2278
73913545|NCT03851705|147356861|SUPERIORITY||Mean Difference (Final Values)|-19.4||||0.2044|TWO_SIDED|95.0|-49.7|10.9||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||10.9|-49.7|0.2044
73913546|NCT03851705|147356861|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.7875|TWO_SIDED|95.0|-39.9|30.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||30.4|-39.9|0.7875
73913547|NCT03851705|147356861|SUPERIORITY||Mean Difference (Final Values)|-15.8||||0.3193|TWO_SIDED|95.0|-47.3|15.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||15.7|-47.3|0.3193
73913548|NCT03851705|147356863|SUPERIORITY||Mean Difference (Final Values)|-10.1||||0.2877|TWO_SIDED|95.0|-29.0|8.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.8|-29.0|0.2877
73913549|NCT03851705|147356863|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.7944|TWO_SIDED|95.0|-19.7|25.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||25.7|-19.7|0.7944
73913550|NCT03851705|147356863|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.5803|TWO_SIDED|95.0|-23.4|13.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||13.3|-23.4|0.5803
73913551|NCT03851705|147356865|SUPERIORITY||Mean Difference (Final Values)|-19.1||||0.4848|TWO_SIDED|95.0|-73.6|35.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||35.3|-73.6|0.4848
73913552|NCT03851705|147356865|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.722|TWO_SIDED|95.0|-56.0|80.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||80.3|-56.0|0.7220
73913553|NCT03851705|147356865|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.8036|TWO_SIDED|95.0|-63.6|49.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||49.5|-63.6|0.8036
73913554|NCT03851705|147356873|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.6028|TWO_SIDED|95.0|-6.8|11.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||11.7|-6.8|0.6028
73913555|NCT03851705|147356873|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.8428|TWO_SIDED|95.0|-11.5|14.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||14.0|-11.5|0.8428
73913556|NCT03851705|147356873|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.4946|TWO_SIDED|95.0|-6.6|13.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||13.4|-6.6|0.4946
73913557|NCT03851705|147356875|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.9237|TWO_SIDED|95.0|-4.0|4.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.4|-4.0|0.9237
73913558|NCT03851705|147356875|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.7177|TWO_SIDED|95.0|-6.5|4.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||4.5|-6.5|0.7177
74026872|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
73913559|NCT03851705|147356875|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.5416|TWO_SIDED|95.0|-2.9|5.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.4|-2.9|0.5416
73913560|NCT03851705|147356877|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.6497|TWO_SIDED|95.0|-3.2|5.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||5.2|-3.2|0.6497
73913561|NCT03851705|147356877|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.3209|TWO_SIDED|95.0|-7.9|2.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||2.6|-7.9|0.3209
73913562|NCT03851705|147356877|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.9294|TWO_SIDED|95.0|-6.3|5.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.7|-6.3|0.9294
73913563|NCT03851705|147356879|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.3105|TWO_SIDED|95.0|-10.8|33.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||33.4|-10.8|0.3105
73913564|NCT03851705|147356879|SUPERIORITY||Mean Difference (Final Values)|-11.4||||0.3018|TWO_SIDED|95.0|-33.3|10.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||10.5|-33.3|0.3018
73913565|NCT03851705|147356879|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.8755|TWO_SIDED|95.0|-27.0|31.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||31.6|-27.0|0.8755
73913566|NCT03851705|147356881|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.6848|TWO_SIDED|95.0|-11.5|7.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||7.6|-11.5|0.6848
73913567|NCT03851705|147356881|SUPERIORITY||Mean Difference (Final Values)|-5.4||||0.4075|TWO_SIDED|95.0|-18.5|7.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||7.6|-18.5|0.4075
73913568|NCT03851705|147356881|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.5998|TWO_SIDED|95.0|-13.4|7.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||7.8|-13.4|0.5998
73965485|NCT05052996|147466265|OTHER||Difference in percentage|1.9|||||TWO_SIDED|95.0|-6.8|11.6|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||11.6|-6.8|
73965486|NCT05052996|147466266|OTHER||Difference in percentage|-1.9|||||TWO_SIDED|95.0|-12.4|8.6|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||8.6|-12.4|
73965487|NCT05052996|147466267|OTHER||Difference in percentage|1.9|||||TWO_SIDED|95.0|-8.6|12.4|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||12.4|-8.6|
73913569|NCT03851705|147356883|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.7958|TWO_SIDED|95.0|-8.4|6.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||6.5|-8.4|0.7958
73913570|NCT03851705|147356883|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.6003|TWO_SIDED|95.0|-12.7|7.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||7.4|-12.7|0.6003
73913571|NCT03851705|147356883|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.5352|TWO_SIDED|95.0|-11.0|5.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.8|-11.0|0.5352
73913572|NCT03851705|147356885|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.1716|TWO_SIDED|95.0|-21.8|4.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.0|-21.8|0.1716
73913573|NCT03851705|147356885|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.1671|TWO_SIDED|95.0|-46.2|8.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||8.2|-46.2|0.1671
74088368|NCT03694808|147730160|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.91|||||TWO_SIDED|95.0|0.71|1.16|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||1.16|0.71|
73913574|NCT03851705|147356885|SUPERIORITY||Mean Difference (Final Values)|-9.7||||0.1808|TWO_SIDED|95.0|-24.2|4.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||4.7|-24.2|0.1808
73913575|NCT03851705|147356887|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.3077|TWO_SIDED|95.0|-28.3|9.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||9.1|-28.3|0.3077
73913576|NCT03851705|147356887|SUPERIORITY||Mean Difference (Final Values)|-9.4||||0.3628|TWO_SIDED|95.0|-30.1|11.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||11.2|-30.1|0.3628
73913577|NCT03851705|147356887|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.4669|TWO_SIDED|95.0|-23.2|10.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||10.8|-23.2|0.4669
73913578|NCT03851705|147356893|SUPERIORITY||Mean Difference (Final Values)|-4.31||||0.6814|TWO_SIDED|95.0|-24.88|16.27|||ANCOVA|||||16.27|-24.88|0.6814
73913579|NCT03851705|147356894|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.8725|TWO_SIDED|95.0|-27.7|23.51|||ANCOVA|||||23.51|-27.70|0.8725
73965488|NCT05052996|147466268|OTHER||difference in least squares means|-68.0||||0.3859|TWO_SIDED|95.0|-226.0|91.0|||ANOVA||P-value, difference in least squares means (Diff in LSM), and its 95% confidence interval (CI) were from ANOVA model with treatment group as a fixed effect in the model.|||91|-226|0.3859
73965489|NCT05052996|147466268|OTHER||difference in least squares means|13.0||||0.7085|TWO_SIDED|95.0|-56.0|82.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||82|-56|0.7085
73965490|NCT05052996|147466269|OTHER||difference in least squares means|33.0||||0.3477|TWO_SIDED|95.0|-37.0|103.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||103|-37|0.3477
74088369|NCT03694808|147730160|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.96|||||TWO_SIDED|95.0|0.69|1.33|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||1.33|0.69|
73913580|NCT03851705|147356895|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.9425|TWO_SIDED|95.0|-22.3|20.72|||ANCOVA|||||20.72|-22.30|0.9425
74085683|NCT01976728|147725593|SUPERIORITY||LSM difference|4.88||||0.0187|TWO_SIDED|95.0|0.878|8.882||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||8.882|0.878|0.0187
74085684|NCT01976728|147725594|SUPERIORITY||LSM difference|0.03||||0.8772|TWO_SIDED|95.0|-0.39|0.46||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.46|-0.39|0.8772
74085685|NCT01976728|147725594|SUPERIORITY||LSM difference|0.07||||0.7805|TWO_SIDED|95.0|-0.44|0.58||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.58|-0.44|0.7805
74085686|NCT01976728|147725594|SUPERIORITY||LSM difference|0.12||||0.6095|TWO_SIDED|95.0|-0.35|0.58||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.58|-0.35|0.6095
73913581|NCT03851705|147356896|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.2|5.2|||Regression, Logistic|||||5.2|0.2|
73913582|NCT00959764|147356904|NON_INFERIORITY_OR_EQUIVALENCE|"Assumed placebo-adjusted effect for both active treatment groups (% increase in BMD)was 1.56% and that the placebo adjusted effect for the rsCT tablets must be at least 0.5 times the placebo adjusted effect for the calcitonin nasal spray (active control treatment group). The null hypothesis to be tested was:~\[Mean(oral) - Mean(placebo)\] - 0.5 x \[Mean(nasal) - Mean(placebo)\] \< 0. Reference Pigeot, et al. 2003"|Mean Difference (Net)|0.77|STANDARD_DEVIATION|2.5||0.002|TWO_SIDED|95.0|0.08|1.45||The P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \<0.05|ANCOVA|||The overall analysis across groups was an Analysis of Covariance where the study was powered to 80% with an assumption of a standard deviation of 2.5% and a two-sided 5% level of significance. For each treatment group, the BMD at 48 weeks was compared with the BMD at baseline and a % increase was calculated (baseline = 0%). This difference was subjected to the t-test. Two-sided P-value is less than or equal to 0.05 and was not adjusted as multiple comparisons were not done.||1.45|0.08|0.002
73913583|NCT00959764|147356905|NON_INFERIORITY_OR_EQUIVALENCE|Same as for Primary Outcome|Mean Difference (Net)|-21.84|STANDARD_DEVIATION|41.99||0.0006||||||P-value not adjusted for multiple comparisons; a priori threshold for significance was 0.05|ANCOVA|95% confidence interval not calculated||Same as for Primary Outcome||||0.0006
73913584|NCT00959764|147356906|NON_INFERIORITY_OR_EQUIVALENCE|Same as Primary Outcome|Mean Difference (Net)|-18.09|STANDARD_DEVIATION|47.53||0.0012||||||p-value not adjusted for multiple comparisons; a priori threshold for statistical significance was set at 0.05.|ANCOVA||oral calcitonin vs placebo|Same as Primary Outcome||||0.0012
73965491|NCT05052996|147466270|OTHER||difference in least squares means|-5.0||||0.8849|TWO_SIDED|95.0|-76.0|66.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||66|-76|0.8849
73913585|NCT00692341|147356907|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|88.61|||||TWO_SIDED|90.0|49.2|159.56||||||For mild hepatic impairment, analysis of variance (ANOVA) was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and confidence intervals (CIs) on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||159.56|49.20|
73913586|NCT00692341|147356907|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|127.67|||||TWO_SIDED|90.0|70.9|229.91||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||229.91|70.90|
73913587|NCT00692341|147356908|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|78.34|||||TWO_SIDED|90.0|39.92|153.75||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||153.75|39.92|
73965492|NCT00522951|147466282|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|-0.58||||||95.0|-0.87|-0.29|||||Averaged blinded reader (primary analysis)|H01: μG1 - μPr ≤ -1||-0.29|-0.87|
73965493|NCT00522951|147466282|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|0.06||||||95.0|-0.23|0.36|||||Averaged blinded reader (primary analysis)|H02: μG2 - μPr ≤ -1||0.36|-0.23|
73965494|NCT00522951|147466282|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|-0.3||||||95.0|-0.5|-0.1|||||Investigator (secondary analysis)|H01: μG1 - μPr ≤ -1||-0.1|-0.5|
73965495|NCT00522951|147466282|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|0.21||||||95.0|0.02|0.41|||||Investigator (secondary analysis)|H02: μG2 - μPr ≤ -1||0.41|0.02|
73913588|NCT00692341|147356908|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|195.25|||||TWO_SIDED|90.0|99.49|383.18||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||383.18|99.49|
73913589|NCT00692341|147356909|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|78.14|||||TWO_SIDED|90.0|38.68|157.82||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||157.82|38.68|
73913590|NCT00692341|147356909|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|198.9|||||TWO_SIDED|90.0|98.47|401.74||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||401.74|98.47|
73913591|NCT00692341|147356914|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|73.78|||||TWO_SIDED|90.0|37.4|145.56||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||145.56|37.40|
73913592|NCT00692341|147356914|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.86|||||TWO_SIDED|90.0|55.58|183.02||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||183.02|55.58|
73913593|NCT00692341|147356915|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.43|||||TWO_SIDED|90.0|44.75|186.79||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||186.79|44.75|
73913594|NCT00692341|147356915|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|50.78|||||TWO_SIDED|90.0|27.14|95.03||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||95.03|27.14|
73913595|NCT00692341|147356916|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|103.09|||||TWO_SIDED|90.0|51.53|206.22||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||206.22|51.53|
73913596|NCT00692341|147356916|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|76.06|||||TWO_SIDED|90.0|41.41|139.73||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||139.73|41.41|
74026873|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.45|0.31|
74026874|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.59|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.59|0.40|
73913597|NCT00692341|147356917|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|109.38|||||TWO_SIDED|90.0|53.54|223.47||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||223.47|53.54|
73965496|NCT00976495|147466306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|2.7177|||TWO_SIDED|95.0|-13.34|-2.49|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||-2.49|-13.34|
73965497|NCT00976495|147466306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.62|STANDARD_ERROR_OF_MEAN|2.7068|||TWO_SIDED|95.0|-12.87|-2.06|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||-2.06|-12.87|
73965498|NCT00976495|147466307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.3613|||TWO_SIDED|95.0|-7.11|2.31|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||2.31|-7.11|
73913598|NCT00692341|147356917|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|196.92|||||TWO_SIDED|90.0|105.23|368.49||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||368.49|105.23|
73913599|NCT00692341|147356918|SUPERIORITY_OR_OTHER||Adjusted ratio of geometric means|111.65|||||TWO_SIDED|90.0|54.35|229.37||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||229.37|54.35|
73913600|NCT00692341|147356918|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|200.6|||||TWO_SIDED|90.0|106.68|377.2||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||377.20|106.68|
73913601|NCT00692341|147356919|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.82|||||TWO_SIDED|90.0|58.22|195.99||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||195.99|58.22|
73913602|NCT00692341|147356919|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|128.76|||||TWO_SIDED|90.0|75.62|219.25||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||219.25|75.62|
73913603|NCT00282984|147356946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.05|||<|0.0001||95.0|4.13|8.86||To preserve type I family-wise error rate of 0.05, used step-down procedure to analyze primary \& 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 thru 12, 2) CA at Week 52, 3) the Long Term Quit Rate (LTQR) thru Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected \& clinically meaningful var \& pbo 4-week CQR for Week 9 - 12 of trtmt based on response rates \& corresponding 95% OR confidence interval (CI) from A30510285 \& A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpoint (endpt) between (b/w) var \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (OR of at least 3.04), and 84% power for 2 key secondary endpts.||8.86|4.13|<0.0001
74026875|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.96|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.96|0.58|
73913604|NCT00282984|147356947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|||<|0.0001||95.0|1.97|5.18||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary \& 2 key secondary endpts. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of treatment group \& center as independent var.||Estimates for expected and clinically meaningful var \& pbo 4-week CQR for Weeks 9 - 12 of trtmt were based on response rates \& corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w var \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (odds ratio of at least 3.04) \& a power of 84% for the 2 key secondary endpts.||5.18|1.97|<0.0001
73913605|NCT00282984|147356948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82|||<|0.0001||95.0|1.82|4.38||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary \& 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) the LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected and clinically meaningful varenicline (var) \& pbo 4-week CQR for Weeks 9 - 12 of treatment were based on response rates \& corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w varenicline \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (odds ratio of at least 3.04), and a power of 84% for the 2 key secondary endpts.||4.38|1.82|<0.0001
74085687|NCT01976728|147725595|SUPERIORITY||LSM difference|0.51||||0.152|TWO_SIDED|95.0|-0.2|1.22||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.22|-0.20|0.1520
73913606|NCT00282984|147356949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.97|||<|0.0001||95.0|4.17|8.56|||Regression, Logistic|||Week 12 analysis||8.56|4.17|<0.0001
73913607|NCT00282984|147356950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93|||<|0.0001||95.0|2.03|4.23|||Regression, Logistic|||24 Week analysis||4.23|2.03|<0.0001
73913608|NCT00282984|147356951|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.0003||95.0|1.34|2.77|||Regression, Logistic|||52 Week analysis||2.77|1.34|0.0003
73913609|NCT00282984|147356952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.0001||95.0|1.41|2.97|||Regression, Logistic|||||2.97|1.41|0.0001
73858929|NCT00901511|147263470|SUPERIORITY||Mean Difference (Final Values)|5.22|STANDARD_ERROR_OF_MEAN|8.26||0.5361|TWO_SIDED|95.0|-12.28|22.73|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||22.73|-12.28|0.5361
73858930|NCT00901511|147263470|SUPERIORITY||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|7.04||0.8159|TWO_SIDED|95.0|-13.26|16.6|||t-test, 2 sided|||The secondary analysis includes evaluation of the difference in mean VC between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.|Calculated as the difference at the 30-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|16.60|-13.26|0.8159
73858931|NCT00901511|147263471|SUPERIORITY||Mean Difference (Final Values)|-0.822||||0.053|TWO_SIDED|95.0|-1.7|0.01|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the median value of the GGO Score in the GM-CSF Group minus the median value of the GGO Score in the Control Group|Primary Analysis||0.01|-1.70|0.0530
73913610|NCT00282984|147356953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.51|5.93|||Regression, Logistic|||||5.93|2.51|<0.0001
73913611|NCT00282984|147356955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.0001||95.0|2.58|5.75|||Regression, Logistic|||||5.75|2.58|<0.0001
73913612|NCT00824720|147356972|SUPERIORITY_OR_OTHER||least square mean difference|-0.22|STANDARD_DEVIATION|2.3||0.9737|||||||ANCOVA||Mean difference was calculated as high dose minus placebo.|The alternative hypothesis was that the high dose was different from the placebo.||||0.9737
73913613|NCT00824720|147356972|SUPERIORITY_OR_OTHER||least square mean difference|-1.11|STANDARD_DEVIATION|3.5||0.4711|||||||ANCOVA||The mean difference was calculated as low dose minus placebo.|The alternative hypothesis is that the low dose was different from placebo.||||0.4711
73913614|NCT03187197|147356994|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 2.||||0.0001
74085688|NCT01976728|147725595|SUPERIORITY||LSM difference|0.93||||0.0221|TWO_SIDED|95.0|0.14|1.72||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.72|0.14|0.0221
74085689|NCT01976728|147725595|SUPERIORITY||LSM difference|0.76||||0.0316|TWO_SIDED|95.0|0.07|1.44||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.44|0.07|0.0316
74088370|NCT03694808|147730161|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.544|||||TWO_SIDED|95.0|-0.674|-0.414|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||-0.414|-0.674|
73913615|NCT03187197|147356994|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 3.||||0.0001
73913616|NCT03187197|147356994|OTHER|||||||0.0031|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 2.||||0.0031
73913617|NCT03187197|147356994|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 3.||||0.0001
73913618|NCT03187197|147356995|OTHER|||||||0.7879|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment convenience before PSM.||||0.7879
73913619|NCT03187197|147356995|OTHER|||||||0.611|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment convenience before PSM.||||0.6110
73913620|NCT03187197|147356995|OTHER|||||||0.0832|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment satisfaction before PSM.||||0.0832
73913621|NCT03187197|147356995|OTHER|||||||0.6488|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment satisfaction before PSM.||||0.6488
73858932|NCT00901511|147263471|SUPERIORITY||Median Difference (Final Values)|0.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||>0.9999
73913622|NCT03187197|147356995|OTHER|||||||0.1301|||||||Two sample T test|||Between group comparison of Visit 2 treatment convenience after PSM.||||0.1301
73913623|NCT03187197|147356995|OTHER|||||||0.1257|||||||Two sample T test|||Between group comparison of Visit 2 treatment satisfaction after PSM.||||0.1257
73965499|NCT00976495|147466307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|2.4112|||TWO_SIDED|95.0|-1.55|8.08|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||8.08|-1.55|
73965500|NCT00976495|147466308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|2.5072|||TWO_SIDED|95.0|-9.38|0.63|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||0.63|-9.38|
73965501|NCT00976495|147466308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|2.5474|||TWO_SIDED|95.0|-4.18|5.99|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||5.99|-4.18|
73965502|NCT00976495|147466309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|2.7812|||TWO_SIDED|95.0|-5.39|5.71|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||5.71|-5.39|
73913624|NCT02200211|147357004|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior Pediatric Eye Disease Investigator Group (PEDIG) studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). The upper limit of a 1-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis. There was no imputation for missing data.||0.53||
73913625|NCT02200211|147357004|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, the primary analysis repeated but excluded data from participants (n=35) who completed the 16-week visit outside of the pre-defined protocol window (16 +/- 1 week).||0.53||
73913626|NCT02200211|147357004|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||ONE_SIDED|95.0||0.54|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=15) or completed the 16-week exam outside of the pre-specified analysis window (n=7).||0.54||
73913627|NCT02200211|147357004|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||ONE_SIDED|95.0||0.56|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates for age and visual acuity. For this post hoc sensitivity analysis, all participants with 16-week exams were included in the analysis regardless of whether or not the exam was completed within the pre-specified analysis window (14 to \<20 weeks after randomization).||0.56||
73913628|NCT02200211|147357004|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16-weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from enrolled participants who were subsequently found to be ineligible for the study (n=7).||0.53||
73913629|NCT02200211|147357004|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||ONE_SIDED|95.0||0.55|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye visual acuity from baseline to 16 week, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from participants who received alternative treatment for at least 1 week during study follow-up (n=4).||0.55||
73913630|NCT02200211|147357004|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|0.04|0.58|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive estimate values favor the patching treatment group.|Analysis of covariance included baseline age and visual acuity as adjustment covariates. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). For this post hoc analysis, a 2-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis.||0.58|0.04|
73965503|NCT00976495|147466309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.31|STANDARD_ERROR_OF_MEAN|2.8135|||TWO_SIDED|95.0|1.7|12.93|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||12.93|1.70|
74088371|NCT03694808|147730161|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.168|||||TWO_SIDED|95.0|-0.311|-0.025|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||-0.025|-0.311|
73858933|NCT00901511|147263471|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0332|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.0332
73858934|NCT00901511|147263471|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0676|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.0676
73858935|NCT00901511|147263471|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0629|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.0629
73858936|NCT00901511|147263471|SUPERIORITY||Median Difference (Final Values)|0.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||>0.9999
73858937|NCT00901511|147263472|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.001|TWO_SIDED|95.0|-0.71|-0.22|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the CEA levels in the GM-CSF Group minus the CEA levels in the Control Group|Primary Analysis||-0.22|-0.71|0.0010
73858938|NCT00901511|147263472|SUPERIORITY||Median Difference (Final Values)|-12.0||||0.0059|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.0059
73858939|NCT00901511|147263472|SUPERIORITY||Median Difference (Final Values)|-3.45||||0.0382|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.0382
73913631|NCT02200211|147357006|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.082|TWO_SIDED|95.0|-5.7|0.3||a priori threshold for statistical significance: 2-sided type I error rate of 5%|ANCOVA|Adjusted for baseline amblyopic-eye visual acuity.|A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 16 weeks. There was no imputation for missing data.||0.3|-5.7|0.082
73913632|NCT02200211|147357006|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-5.9|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants who completed the 16-week visit outside of the pre-specified 16 +/- 1 week protocol window (n=10 participants).||0.5|-5.9|
73965504|NCT02538341|147466310|OTHER|||||||0.0023||||||p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.|a generalized linear model|p value,from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.||Study protocol defined measure for immunogenicity samples. Participants must have at least 1 post vaccine immunogenicity measure to determine the GMFR (a priori analysis)||||0.0023
73965505|NCT02538341|147466311|OTHER|||||||0.31||||||p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.|a generalized linear model|p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.||Study protocol defined measure for immunogenicity samples. Participants must have at least 1 post vaccine immunogenicity measure to determine the GMFR (a priori analysis)||||0.31
74026876|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.67|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.13|0.67|
74026877|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.37|0.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.67|0.37|
74026878|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.57|1.12|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.12|0.57|
73913633|NCT02200211|147357006|SUPERIORITY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-5.9|0.3|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants later found to be ineligible for the study (n=2).||0.3|-5.9|
73858940|NCT00901511|147263472|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.0770
73858941|NCT00901511|147263472|SUPERIORITY||Median Difference (Final Values)|-4.0||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.0400
73858942|NCT00901511|147263472|SUPERIORITY||Median Difference (Final Values)|-7.9||||0.0142|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||0.0142
73858943|NCT00901511|147263472|SUPERIORITY||Median Difference (Final Values)|-6.5||||0.0071|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.0071
73858944|NCT00901511|147263472|SUPERIORITY||Median Difference (Final Values)|-5.6||||0.0137|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.0137
73858945|NCT00901511|147263472|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.0315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.0315
73858946|NCT00901511|147263473|SUPERIORITY||Mean Difference (Final Values)|-3689.0||||0.03|TWO_SIDED|95.0|-6972.0|-406.0|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the KL-6 levels in the GM-CSF Group minus the KL-6 levels in the Control Group|Primary Analysis||-406|-6972|0.0300
73858947|NCT00901511|147263473|SUPERIORITY||Median Difference (Final Values)|-3265.0||||0.077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.0770
73858948|NCT00901511|147263473|SUPERIORITY||Median Difference (Final Values)|-5018.0||||0.0745|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.0745
73858949|NCT00901511|147263473|SUPERIORITY||Median Difference (Final Values)|-6343.0||||0.2581|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.2581
73858950|NCT00901511|147263473|SUPERIORITY||Median Difference (Final Values)|-4102.0||||0.4894|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.4894
73858951|NCT00901511|147263473|SUPERIORITY||Median Difference (Final Values)|-6818.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||>0.9999
73913634|NCT02200211|147357006|SUPERIORITY||Mean Difference (Final Values)|-1.9|||||TWO_SIDED|95.0|-5.0|1.2|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=3) or completed the 16-week exam outside of the pre-specified analysis window (n=2).||1.2|-5.0|
73965506|NCT02382744|147466367|SUPERIORITY_OR_OTHER||Difference between proportions (%)|10.0||||0.25|TWO_SIDED|95.0|-11.9|31.9||One-sided P-value based on the lack of plausibility that additional nerve stimulation would worsen sensory blockade rates.|Fisher Exact|||We sought to detect an increase in the rate of complete absence of sensation to pinprick 30 min following ultrasound-guided subsartorial saphenous nerve blockade to 90% from an assumed baseline of 64% as extrapolated from our previous study (cf. Head SJ et al. 2015) at β = 0.2. The required minimum sample size at α = 0.05 (one-sided) was 30 patients in each group. To be conservative, we aimed to enroll a total of 80 patients.||31.9|-11.9|0.25
73965507|NCT02382744|147466368|SUPERIORITY_OR_OTHER|||||||0.62||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."||||0.62
73965508|NCT02382744|147466369|SUPERIORITY_OR_OTHER|||||||0.62|||||||Fisher Exact|||||||0.62
73965509|NCT02382744|147466370|SUPERIORITY_OR_OTHER|||||||0.26||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, incomplete block at 30 minutes post nerve block versus no incomplete block at 30 minutes post nerve block."||||0.26
73965510|NCT02382744|147466371|SUPERIORITY_OR_OTHER||"Median survival ratio"|0.7||||0.12|TWO_SIDED|95.0|0.38|1.31|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"|"To assess speed of onset, sensation to pinprick in the distribution of the saphenous nerve was assessed for each patient every 5 min until complete sensory loss was noted, or until 30 min had elapsed. To compare the two groups in speed of onset on the basis of these data, we constructed Kaplan-Meyer survival curves for the times to onset of sensory blockade and compared the underlying time-to-event data with the log-rank test."||1.31|0.38|0.12
73858952|NCT00901511|147263473|SUPERIORITY||Median Difference (Final Values)|-1570.0||||0.8633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.8633
73858953|NCT00901511|147263473|SUPERIORITY||Median Difference (Final Values)|-4200.0||||0.3401|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.3401
73858954|NCT00901511|147263473|SUPERIORITY||Median Difference (Final Values)|-4307.0||||0.2973|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.2973
73858955|NCT00901511|147263474|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.22|TWO_SIDED|95.0|-0.44|-0.04|||Repeated measures ANOVA||Calculated as the between group difference in the serum Cyfra21.1 levels in the GM-CSF Group minus the serum Cyfra21.1 levels in the Control Group|Primary Analysis||-0.04|-0.44|0.220
73858956|NCT00901511|147263474|SUPERIORITY||Mean Difference (Final Values)|-14.19|STANDARD_ERROR_OF_MEAN|6.76||0.056|TWO_SIDED|95.0|-28.8|0.42|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|•The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.42|-28.80|0.0560
73858957|NCT00901511|147263474|SUPERIORITY||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|2.15||0.0648|TWO_SIDED|95.0|-8.8|0.29|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||0.29|-8.80|0.0648
73858958|NCT00901511|147263474|SUPERIORITY||Mean Difference (Final Values)|-6.27|STANDARD_ERROR_OF_MEAN|2.36||0.0175|TWO_SIDED|95.0|-11.28|-1.25|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||-1.25|-11.28|0.0175
73965511|NCT02382744|147466375|SUPERIORITY_OR_OTHER||Difference between means (s)|107.0|||<|0.0001|TWO_SIDED|95.0|61.0|153.0|||t-test, 2 sided|||||153|61|<0.0001
73965512|NCT02382744|147466378|SUPERIORITY_OR_OTHER||"Median survival ratio"|0.58||||0.02|TWO_SIDED|95.0|0.37|0.93|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"|||0.93|0.37|0.02
73965513|NCT02382744|147466381|SUPERIORITY_OR_OTHER|||||||0.0057|||||||Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two arms, Patients with response to nerve stimulation and Patients with lack response to nerve stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."||||0.0057
73965514|NCT04402294|147466500|OTHER|Parametric inferential statistical test|Group mean difference|0.71||||0.5|TWO_SIDED|||||The threshold for statistical significance was set to p = 0.05|ANOVA|||ANOVA (Optimal vs Suboptimal vs No Stimulation)||||0.50
73965515|NCT04402294|147466501|OTHER|Parametric inferential statistical test|Group mean difference|0.03||||0.975|TWO_SIDED|||||The threshold for statistical significance was set to p = 0.05|ANOVA|||ANOVA (Optimal vs Suboptimal vs No Stimulation)||||0.975
73965516|NCT04402294|147466502|OTHER|Parametric inferential statistical test|Group mean difference|2.05||||0.097|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), stimulation days (1 to 3), and delay (0, 4, or 12 seconds) as within-subject variables.||||0.097
73913635|NCT02200211|147357006|SUPERIORITY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-5.5|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this post hoc sensitivity analyses, the primary analysis was repeated but included data from participants who completed the 16-week visit outside the analysis window (n=2, range:14 to 28 weeks post randomization).||0.5|-5.5|
73913636|NCT02200211|147357006|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-5.7|0.4|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but included prior amblyopia treatment as an adjustment covariate (in addition to baseline visual acuity) in the model.||0.4|-5.7|
73913637|NCT02200211|147357010|SUPERIORITY||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-4.0|13.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as improving 2 or more logMAR lines from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to \<7, 7 to \<13 years) and baseline visual acuity (treated as a continuous covariate).||13|-4|
73913638|NCT02200211|147357010|SUPERIORITY||Risk Difference (RD)|-15.0|||||TWO_SIDED|95.0|-31.0|2.0|||||Binomial regression was used to compare the group proportions (binocular treatment - patching) of participants classified as improving 2 or more logMAR lines (≥ 10 letters) from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline visual acuity.||2|-31|
73913639|NCT02200211|147357011|SUPERIORITY||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-1.0|5.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as having amblyopia resolution at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to \<7, 7 to \<13 years) and baseline visual acuity (20/40, 20/50 or worse).||5|-1|
73913640|NCT02200211|147357012|SUPERIORITY|||||||0.83||||||For testing the interaction term, the a priori threshold for statistical significance was 0.05.|ANCOVA|Previously described above in the Statistical Analysis Overview section.||A linear mixed model was used to compare the rate of amblyopic-eye visual acuity improvement between the treatment groups. The ANCOVA model included an interaction term with treatment group and time to compare the change in visual acuity over follow-up by treatment group, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity. If the interaction term was not statistically significant (p\>0.05), no further comparisons would be performed.||||0.83
73913641|NCT02200211|147357013|SUPERIORITY|||||||0.83||||||The a priori threshold for statistical significance of the interaction term (gender and treatment group) was 0.05.|ANCOVA|Previously described in the Statistical Analysis Overview.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and gender, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.83
73913642|NCT02200211|147357013|SUPERIORITY|||||||0.54||||||The a priori threshold for statistical significance of the interaction term (race/ethnicity status and treatment group) was 0.05.|ANCOVA|Four participants (1 binocular treatment group, 3 patching group) were excluded from the analysis due to unknown/not reported race/ethnicity status.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and race/ethnicity status (White/non-Hispanic, Non-White or Hispanic), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.54
73913643|NCT02200211|147357013|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance of the interaction term (age and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and age at baseline (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline visual acuity.||||0.80
73913644|NCT02200211|147357013|SUPERIORITY|||||||0.99||||||The a priori threshold for statistical significance of the interaction term (baseline amblyopic-eye visual acuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline amblyopic-eye visual acuity (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline age.||||0.99
73913645|NCT02200211|147357013|SUPERIORITY|||||||0.87||||||The a priori threshold for statistical significance of the interaction term (prior amblyopia treatment and treatment group) was 0.05|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and prior amblyopia treatment (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.87
73965517|NCT04402294|147466503|OTHER|Parametric Inferential Statistical Test|Group mean difference|0.63||||0.644|TWO_SIDED|||||The threshold for statistical significance was 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), stimulation days (1 to 3), and delay (0, 4, or 12 seconds) as within-subject variables.||||0.644
73913646|NCT02200211|147357013|SUPERIORITY|||||||0.33||||||The a priori threshold for statistical significance of the interaction term (baseline stereoacuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline stereoacuity (nil, better than nil), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.33
73913647|NCT02200211|147357013|SUPERIORITY|||||||0.23||||||The a priori threshold for statistical significance of the interaction term (presence of a near heterotropia at baseline and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and presence of a near heterotropia (measured by SPCT) at baseline (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.23
73913648|NCT02200211|147357018|SUPERIORITY|||||||0.66||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.66
73913649|NCT02200211|147357018|SUPERIORITY|||||||0.83||||||A priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.83
73913650|NCT02200211|147357019|SUPERIORITY|||||||0.19||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.19
73913651|NCT02200211|147357019|SUPERIORITY|||||||0.69||||||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.69
73913652|NCT02200211|147357025|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|0.02|0.3|||||A 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) in mean change in fellow-eye visual acuity from baseline to 16 weeks. Positive values favor the binocular treatment group.|The treatment group difference in the change in fellow-eye visual acuity from baseline to 16 weeks (logMAR lines) was evaluated in an analysis of covariance model, adjusted for baseline fellow-eye visual acuity.||0.30|0.02|
73913653|NCT02200211|147357026|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-1.1|1.3|||||A 95% confidence interval was computed on the treatment group difference (binocular treatment - patching) of the adjusted mean change in fellow-eye visual acuity from baseline to 16 weeks.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 16 weeks, adjusting for baseline visual acuity. A 2-sided 95% confidence interval was computed on the adjusted treatment group difference.||1.3|-1.1|
73913654|NCT02200211|147357027|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.||||0.32
73913655|NCT02200211|147357027|SUPERIORITY|||||||0.68|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.||||0.68
73913656|NCT02200211|147357028|SUPERIORITY|||||||0.17|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.||||0.17
73913657|NCT02200211|147357028|SUPERIORITY|||||||0.48|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.48
73913658|NCT02200211|147357028|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.||||>0.99
73913659|NCT02200211|147357028|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
73913660|NCT02200211|147357029|SUPERIORITY|||||||0.05|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.||||0.05
73913661|NCT02200211|147357029|SUPERIORITY|||||||0.02|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.02
74026879|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.09|0.85|
74085690|NCT01976728|147725597|SUPERIORITY||LSM difference|73.0||||0.3147|TWO_SIDED|95.0|-72.66|218.65||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||218.65|-72.66|0.3147
73913662|NCT02200211|147357029|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.||||>0.99
73913663|NCT02200211|147357029|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
74026880|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.04|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.04|
74026881|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.48|0.62|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.48|
74026882|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.59|0.83|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.83|0.59|
74026883|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.57|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.72|0.57|
74026884|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.65|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.65|
74026885|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|0.93|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.93|0.66|
74026886|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.05|0.75|
74088372|NCT03694808|147730162|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.104|||||TWO_SIDED|95.0|-0.221|0.013|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.013|-0.221|
73858959|NCT00901511|147263474|SUPERIORITY||Mean Difference (Final Values)|-16.81|STANDARD_ERROR_OF_MEAN|6.16||0.0148|TWO_SIDED|95.0|-29.85|-3.76|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||-3.76|-29.85|0.0148
73858960|NCT00901511|147263474|SUPERIORITY||Mean Difference (Final Values)|-5.41|STANDARD_ERROR_OF_MEAN|1.82||0.0089|TWO_SIDED|95.0|-9.27|-1.56|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||-1.56|-9.27|0.0089
73858961|NCT00901511|147263474|SUPERIORITY||Mean Difference (Final Values)|-5.18|STANDARD_ERROR_OF_MEAN|2.24||0.0343|TWO_SIDED|95.0|-9.92|-0.43|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||-0.43|-9.92|0.0343
73858962|NCT00901511|147263474|SUPERIORITY||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|2.33||0.0871|TWO_SIDED|95.0|-9.21|0.69|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||0.69|-9.21|0.0871
73858963|NCT00901511|147263474|SUPERIORITY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|2.4||0.2265|TWO_SIDED|95.0|-8.09|2.06|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||2.06|-8.09|0.2265
73858964|NCT00901511|147263475|SUPERIORITY||Median Difference (Final Values)|8.78||||0.3865|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.3865
73913664|NCT00381485|147357032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73913665|NCT00381485|147357032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73913666|NCT00844831|147357121|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
73913667|NCT00844831|147357123|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||.9
73913668|NCT01581931|147357140|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.69|STANDARD_DEVIATION|9.7|||TWO_SIDED|95.0|93.63|101.94|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||101.94|93.63|
73913669|NCT01581931|147357143|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.76|STANDARD_DEVIATION|9.8|||TWO_SIDED|90.0|93.64|102.07|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||102.07|93.64|
73913670|NCT01581931|147357144|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|98.79|STANDARD_DEVIATION|10.0|||TWO_SIDED|90.0|94.55|103.21|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||103.21|94.55|
73913671|NCT03156543|147357145|SUPERIORITY|||||||0.004|||||||Fisher Exact|||Analysis was based on the participants who were positive for C. acnes.||||0.004
73913672|NCT00674700|147357147|SUPERIORITY_OR_OTHER|||||||0.0066||||||main effects = treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA|||||||0.0066
73913673|NCT00674700|147357147|SUPERIORITY_OR_OTHER|||||||0.015||||||main effects= treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA|||||||0.015
73965518|NCT04402294|147466504|OTHER|Parametric inferential statistical test|Group mean difference|0.84||||0.439|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), and stimulation days (1 to 3) as within-subject variables.||||0.439
73965519|NCT04402294|147466505|OTHER|Parametric inferential statistical test|Group mean difference|0.59||||0.563|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||Optimal Neuromodulation Day-1, Optimal Neuromodulation Day-2, Optimal Neuromodulation Day-3, Suboptimal Neuromodulation Day-1, Suboptimal Neuromodulation Day-2, Suboptimal Neuromodulation Day-3||||0.563
73913674|NCT00674700|147357148|SUPERIORITY_OR_OTHER|||||||0.0086|||||||ANCOVA|||||||0.0086
73913675|NCT00674700|147357148|SUPERIORITY_OR_OTHER|||||||0.0095|||||||ANCOVA|||||||0.0095
73913676|NCT01509950|147357179|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
73913677|NCT04115839|147357201|SUPERIORITY||Difference in response rates|26.9||||0.022|TWO_SIDED|95.0|4.3|49.6||The stratification factors (Geographic Region, Concurrent Use of conventional synthetic (cs) DMARD(s) and/or Apremilast at Randomization, Prior Use of biologic (bio)DMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||49.6|4.3|0.022
73913678|NCT04115839|147357201|SUPERIORITY||Difference in response rates|2.2||||0.89|TWO_SIDED|95.0|-20.5|25.0||The stratification factors (Geographic Region, Concurrent Use of csDMARD(s) and/or Apremilast at Randomization, Prior Use of bioDMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||25.0|-20.5|0.89
73965520|NCT02975505|147466516|SUPERIORITY||beta|11.7|||<|0.05|TWO_SIDED|95.0|7.5|16.0|||Mixed Models Analysis|||||16|7.5|<0.05
73913679|NCT04115839|147357204|SUPERIORITY||Difference in response rates|-5.9||||0.39|TWO_SIDED|95.0|-21.6|9.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||9.9|-21.6|0.39
73913680|NCT04115839|147357204|SUPERIORITY||Difference in response rates|-2.6||||0.65|TWO_SIDED|95.0|-19.7|14.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||14.5|-19.7|0.65
74026887|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.27|0.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.37|0.27|
73913681|NCT04115839|147357204|SUPERIORITY||Difference in response rates|0.9||||0.86|TWO_SIDED|-19.4|-19.4|21.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||21.3|-19.4|0.86
73965521|NCT02975505|147466519|SUPERIORITY||beta|12.5||||0.05|TWO_SIDED|95.0|8.0|16.0|||Mixed Models Analysis|||||16|8|0.05
73965522|NCT05769595|147466534|OTHER||Geometric Mean Ratio|2.51|||||TWO_SIDED|90.0|2.24|2.82|||||Geometric mean ratio is MK-2060/placebo|||2.82|2.24|
73965523|NCT03661359|147466535|OTHER|||||||0.727||||||correlation is significant at the 0.05 level (2 tailed)|pearson correlation|||Correlation between patient satisfaction and domains at risk.||||.727
73965524|NCT03661359|147466537|OTHER|||||||0.002||||||correlation is significant at the 0.01 level 2 tailed|pearson correlation|||correlation between physical quality of life and mental of life||||0.002
73965525|NCT03661359|147466539|OTHER|||||||0.727|TWO_SIDED|0.05|||||pearson correlation|||||||0.727
73965526|NCT03683069|147466545|SUPERIORITY|||||||0.823|||||||Regression, Linear|||adjusted to medication dose, sex, age, race||||0.823
73965527|NCT03683069|147466545|SUPERIORITY|||||||0.839|||||||Regression, Linear|||diastolic bp adjusted for medication dose sex,age, race||||.8390
73965528|NCT03683069|147466546|SUPERIORITY|||||||0.0101|||||||Wilcoxon (Mann-Whitney)|||||||.0101
73965529|NCT03683069|147466547|SUPERIORITY|||||||0.59|||||||ANOVA|||||||0.59
73965530|NCT03683069|147466548|SUPERIORITY||Hazard Ratio, log|0.7022||||0.09|TWO_SIDED||||||Kaplan-Meier using Gehan-Breslow-Wilcoxo|||||||.09
73913682|NCT04115839|147357204|SUPERIORITY||Difference in response rates|-2.9||||0.7|TWO_SIDED|95.0|-22.0|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||16.1|-22.0|0.70
73913683|NCT04115839|147357204|SUPERIORITY||Difference in response rates|12.4||||0.15|TWO_SIDED|95.0|-7.5|32.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||32.3|-7.5|0.15
74026888|NCT01025336|147607521|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.48|0.34|
73913684|NCT04115839|147357204|SUPERIORITY||Difference in response rates|8.8||||0.3|TWO_SIDED|95.0|-10.1|27.7||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||27.7|-10.1|0.30
73913685|NCT04115839|147357204|SUPERIORITY||Difference in response rates|22.3||||0.035|TWO_SIDED|95.0|-0.7|45.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||45.2|-0.7|0.035
73913686|NCT04115839|147357204|SUPERIORITY||Difference in response rates|12.1||||0.22|TWO_SIDED|95.0|-9.3|33.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.5|-9.3|0.22
73913687|NCT04115839|147357206|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.8|2.8|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.8|-2.8|
73913688|NCT04115839|147357206|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
73913689|NCT04115839|147357206|SUPERIORITY||Difference in response rates|3.1|||||TWO_SIDED|95.0|-5.9|12.2|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 8||12.2|-5.9|
73913690|NCT04115839|147357206|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 8||2.9|-2.9|
73913691|NCT04115839|147357206|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-5.8|11.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 12||11.9|-5.8|
73913692|NCT04115839|147357206|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-5.0|16.7|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 12||16.7|-5.0|
73913693|NCT04115839|147357206|SUPERIORITY||Difference in response rates|0.1|||||TWO_SIDED|95.0|-11.4|11.6|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 16||11.6|-11.4|
74026889|NCT01025336|147607522|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.22|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.22|0.85|
74026890|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.02|0.79|
74026891|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.69|0.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.90|0.69|
73913694|NCT04115839|147357206|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-10.0|16.1|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 16||16.1|-10.0|
73913695|NCT04115839|147357214|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.24|TWO_SIDED|95.0|-1.0|0.0||P-value was provided from mixed-effects model for repeated measures (MMRM) having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0|-1|0.24
73913696|NCT04115839|147357214|SUPERIORITY||LS Mean Treatment Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.22|TWO_SIDED|95.0|-1.0|0.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0|-1|0.22
73913697|NCT04115839|147357214|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.43|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||1|-1|0.43
73913698|NCT04115839|147357214|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.7|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||1|-1|0.70
73913699|NCT04115839|147357214|SUPERIORITY||LS Mean Treatment Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.1|TWO_SIDED|95.0|-2.0|0.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||0|-2|0.10
73913700|NCT04115839|147357214|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.9|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||1|-1|0.90
73913701|NCT04115839|147357214|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.88|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||1|-1|0.88
73913702|NCT04115839|147357214|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.89|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||1|-1|0.89
73913703|NCT04115839|147357218|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-15.9|16.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||16.5|-15.9|
73913704|NCT04115839|147357218|SUPERIORITY||Difference in response rates|12.6|||||TWO_SIDED|95.0|-7.1|32.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||32.3|-7.1|
73913705|NCT04115839|147357218|SUPERIORITY||Difference in response rates|26.6|||||TWO_SIDED|95.0|3.0|50.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||50.2|3.0|
73913706|NCT04115839|147357218|SUPERIORITY||Difference in response rates|18.2|||||TWO_SIDED|95.0|-4.1|40.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.4|-4.1|
73913707|NCT04115839|147357220|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-5.6|11.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||11.5|-5.6|
73913708|NCT04115839|147357220|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
73913709|NCT04115839|147357220|SUPERIORITY||Difference in response rates|12.9|||||TWO_SIDED|95.0|-2.0|27.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.8|-2.0|
73913710|NCT04115839|147357220|SUPERIORITY||Difference in response rates|9.1|||||TWO_SIDED|95.0|-3.7|21.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.9|-3.7|
73913711|NCT04115839|147357222|SUPERIORITY||Difference in response rates|15.4||||0.098|TWO_SIDED|95.0|-5.5|36.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||36.3|-5.5|0.098
73913712|NCT04115839|147357222|SUPERIORITY||Difference in response rates|-5.1||||0.4|TWO_SIDED|95.0|-21.1|11.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||11.0|-21.1|0.40
73913713|NCT04115839|147357222|SUPERIORITY||Difference in response rates|10.8||||0.26|TWO_SIDED|95.0|-12.6|34.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||34.3|-12.6|0.26
73913714|NCT04115839|147357222|SUPERIORITY||Difference in response rates|8.8||||0.39|TWO_SIDED|95.0|-14.6|32.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||32.2|-14.6|0.39
73913715|NCT04115839|147357222|SUPERIORITY||Difference in response rates|20.0||||0.088|TWO_SIDED|95.0|-6.9|46.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.9|-6.9|0.088
73913716|NCT04115839|147357222|SUPERIORITY||Difference in response rates|-7.0||||0.49|TWO_SIDED|95.0|-32.9|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||18.9|-32.9|0.49
73913717|NCT04115839|147357222|SUPERIORITY||Difference in response rates|28.3||||0.019|TWO_SIDED|95.0|2.4|54.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||54.2|2.4|0.019
73913718|NCT04115839|147357222|SUPERIORITY||Difference in response rates|2.9||||0.85|TWO_SIDED|95.0|-22.5|28.4||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||28.4|-22.5|0.85
73913719|NCT04115839|147357222|SUPERIORITY||Difference in response rates|25.9||||0.036|TWO_SIDED|95.0|-0.4|52.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||52.3|-0.4|0.036
73913720|NCT04115839|147357222|SUPERIORITY||Difference in response rates|6.1||||0.6|TWO_SIDED|95.0|-19.7|31.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||31.8|-19.7|0.60
73913721|NCT04115839|147357224|SUPERIORITY||Difference in response rates|6.0||||0.31|TWO_SIDED|95.0|-7.8|19.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.8|-7.8|0.31
73913722|NCT04115839|147357224|SUPERIORITY||Difference in response rates|-2.8||||0.48|TWO_SIDED|95.0|-11.1|5.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||5.5|-11.1|0.48
73913723|NCT04115839|147357224|SUPERIORITY||Difference in response rates|2.5||||0.7|TWO_SIDED|95.0|-14.1|19.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||19.2|-14.1|0.70
73913724|NCT04115839|147357224|SUPERIORITY||Difference in response rates|-8.6||||0.17|TWO_SIDED|95.0|-20.7|3.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||3.6|-20.7|0.17
73913725|NCT04115839|147357224|SUPERIORITY||Difference in response rates|6.5||||0.34|TWO_SIDED|95.0|-12.5|25.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||25.6|-12.5|0.34
73913726|NCT04115839|147357224|SUPERIORITY||Difference in response rates|-0.3||||0.98|TWO_SIDED|95.0|-16.9|16.4||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||16.4|-16.9|0.98
73913727|NCT04115839|147357224|SUPERIORITY||Difference in response rates|18.7||||0.071|TWO_SIDED|95.0|-5.1|42.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||42.5|-5.1|0.071
73913728|NCT04115839|147357224|SUPERIORITY||Difference in response rates|-8.8||||0.27|TWO_SIDED|95.0|-27.7|10.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||10.1|-27.7|0.27
73913729|NCT04115839|147357224|SUPERIORITY||Difference in response rates|40.7||||0.002|TWO_SIDED|95.0|19.5|62.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||62.0|19.5|0.002
73913730|NCT04115839|147357224|SUPERIORITY||Difference in response rates|15.2||||0.082|TWO_SIDED|95.0|-2.3|32.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||32.6|-2.3|0.082
73913731|NCT04115839|147357226|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-5.6|11.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||11.5|-5.6|
73913732|NCT04115839|147357226|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||2.9|-2.9|
73858965|NCT00901511|147263475|SUPERIORITY||Median Difference (Final Values)|7.82||||0.1672|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.1672
73858966|NCT00901511|147263475|SUPERIORITY||Median Difference (Final Values)|4.24||||0.4363|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.4363
73913733|NCT04115839|147357226|SUPERIORITY||Difference in response rates|2.8|||||TWO_SIDED|95.0|-5.4|11.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||11.0|-5.4|
73913734|NCT04115839|147357226|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
73858967|NCT00901511|147263475|SUPERIORITY||Median Difference (Final Values)|7.34||||0.1615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.1615
73858968|NCT00901511|147263475|SUPERIORITY||Median Difference (Final Values)|13.71||||0.1615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||0.1615
73858969|NCT00901511|147263475|SUPERIORITY||Median Difference (Final Values)|11.1||||0.3865|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.3865
73858970|NCT00901511|147263475|SUPERIORITY||Median Difference (Final Values)|5.4||||0.6475|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||• Calculated as the difference at the 18-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.6475
73858971|NCT00901511|147263475|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.6481|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.6481
73858972|NCT00901511|147263476|SUPERIORITY||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.78||0.0582|TWO_SIDED|95.0|-3.17|0.06|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.06|-3.17|0.0582
73858973|NCT00901511|147263476|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|1.09||0.3068|TWO_SIDED|95.0|-1.17|3.48|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||3.48|-1.17|0.3068
73913735|NCT04115839|147357226|SUPERIORITY||Difference in response rates|12.7|||||TWO_SIDED|95.0|-4.2|29.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||29.5|-4.2|
74085691|NCT01976728|147725597|SUPERIORITY||LSM difference|95.18||||0.229|TWO_SIDED|95.0|-63.01|253.36||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||253.36|-63.01|0.2290
73858974|NCT00901511|147263476|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.75||0.5647|TWO_SIDED|95.0|-2.04|1.15|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||1.15|-2.04|0.5647
73913736|NCT04115839|147357226|SUPERIORITY||Difference in response rates|-2.9|||||TWO_SIDED|95.0|-11.6|5.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||5.7|-11.6|
73913737|NCT04115839|147357226|SUPERIORITY||Difference in response rates|18.3|||||TWO_SIDED|95.0|0.2|36.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||36.3|0.2|
73913738|NCT04115839|147357226|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-9.7|15.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||15.6|-9.7|
73913739|NCT04115839|147357226|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-2.0|27.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.0|-2.0|
73858975|NCT00901511|147263476|SUPERIORITY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.59||0.1669|TWO_SIDED|95.0|-2.11|0.4|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||0.40|-2.11|0.1669
74026892|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.1|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.10|0.82|
74026893|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.98|1.32|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.32|0.98|
74026894|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.62|0.81|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.81|0.62|
74026895|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.41|
74026896|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.82|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.82|0.60|
74085692|NCT01976728|147725597|SUPERIORITY||LSM difference|46.99||||0.5066|TWO_SIDED|95.0|-95.64|189.61||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||189.61|-95.64|0.5066
73858976|NCT00901511|147263476|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|0.69||0.453|TWO_SIDED|95.0|-1.99|0.93|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||0.93|-1.99|0.4530
73858977|NCT00901511|147263476|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.71||0.4594|TWO_SIDED|95.0|-2.04|0.97|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||0.97|-2.04|0.4594
73858978|NCT00901511|147263476|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.62||0.6302|TWO_SIDED|95.0|-1.61|1.0|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||1.00|-1.61|0.6302
73858979|NCT00901511|147263476|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.72||0.33|TWO_SIDED|95.0|-2.24|0.8|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||0.80|-2.24|0.3300
73858980|NCT00901511|147263477|SUPERIORITY||Mean Difference (Final Values)|-53.72|STANDARD_ERROR_OF_MEAN|38.79||0.1864|TWO_SIDED|95.0|-136.4|28.96|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||28.96|-136.4|0.1864
73858981|NCT00901511|147263477|SUPERIORITY||Mean Difference (Final Values)|-21.17|STANDARD_ERROR_OF_MEAN|46.3||0.6541|TWO_SIDED|95.0|-119.8|77.51|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||77.51|-119.8|0.6541
73858982|NCT00901511|147263477|SUPERIORITY||Mean Difference (Final Values)|-18.78|STANDARD_ERROR_OF_MEAN|24.58||0.456|TWO_SIDED|95.0|-70.89|33.33|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||33.33|-70.89|0.4560
73858983|NCT00901511|147263477|SUPERIORITY||Mean Difference (Final Values)|-28.44|STANDARD_ERROR_OF_MEAN|30.98||0.3721|TWO_SIDED|95.0|-94.12|37.23|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||37.23|-94.12|0.3721
74085693|NCT00966381|147725608|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73858984|NCT00901511|147263477|SUPERIORITY||Mean Difference (Final Values)|-28.78|STANDARD_ERROR_OF_MEAN|20.58||0.1812|TWO_SIDED|95.0|-72.41|14.86|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||14.86|-72.41|0.1812
73858985|NCT00901511|147263477|SUPERIORITY||Mean Difference (Final Values)|-26.11|STANDARD_ERROR_OF_MEAN|23.38||0.2805|TWO_SIDED|95.0|-75.67|23.44|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||23.44|-75.67|0.2805
73858986|NCT00901511|147263477|SUPERIORITY||Mean Difference (Final Values)|-27.33|STANDARD_ERROR_OF_MEAN|22.75||0.247|TWO_SIDED|95.0|-75.56|20.89|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||20.89|-75.56|0.2470
73858987|NCT00901511|147263477|SUPERIORITY||Mean Difference (Final Values)|-31.0|STANDARD_ERROR_OF_MEAN|23.57||0.207|TWO_SIDED|95.0|-80.97|18.97|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||18.97|-80.97|0.2070
73858988|NCT00901511|147263478|SUPERIORITY||Mean Difference (Final Values)|4.72||||0.149|TWO_SIDED|95.0|-1.88|11.33|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the difference in the mean value of the SF-36 General Health Score in the GM-CSF Group minus the Control Group|Primary analysis||11.33|-1.88|0.1490
73858989|NCT00901511|147263478|SUPERIORITY||Mean Difference (Final Values)|-4.31|STANDARD_ERROR_OF_MEAN|12.07||0.7263|TWO_SIDED|95.0|-30.04|21.43|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||21.43|-30.04|0.7263
73858990|NCT00901511|147263478|SUPERIORITY||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|8.29||0.3298|TWO_SIDED|95.0|-9.24|25.91|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in SF-36 General Health Score between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||25.91|-9.24|0.3298
73858991|NCT00901511|147263478|SUPERIORITY||Mean Difference (Final Values)|13.89|STANDARD_ERROR_OF_MEAN|6.48||0.0478|TWO_SIDED|95.0|-0.15|27.62|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in SF-36 General Health Score between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||27.62|-0.15|0.0478
73858992|NCT00901511|147263478|SUPERIORITY||Mean Difference (Final Values)|17.78|STANDARD_ERROR_OF_MEAN|7.37||0.0281|TWO_SIDED|95.0|2.16|33.39|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||33.39|2.16|0.0281
73858993|NCT00901511|147263478|SUPERIORITY||Mean Difference (Final Values)|11.67|STANDARD_ERROR_OF_MEAN|10.07||0.2634|TWO_SIDED|95.0|-9.67|33.0|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||33.00|-9.67|0.2634
73858994|NCT00901511|147263478|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|10.49||0.3548|TWO_SIDED|95.0|-12.24|32.24|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||32.24|-12.24|0.3548
73858995|NCT00901511|147263478|SUPERIORITY||Mean Difference (Final Values)|16.67|STANDARD_ERROR_OF_MEAN|9.68||0.1043|TWO_SIDED|95.0|-3.85|37.18|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||37.18|-3.85|0.1043
73858996|NCT01444027|147263497|SUPERIORITY|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status||||||0.002
73858997|NCT01444027|147263497|SUPERIORITY|||||||0.9||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|||||||0.90
73858998|NCT01444027|147263497|SUPERIORITY|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.002
74085694|NCT00966381|147725609|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74085695|NCT00966381|147725610|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73858999|NCT01444027|147263498|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for the baseline value of the measure, hospice agency, and bereaved status.||||||0.001
73859000|NCT01444027|147263498|SUPERIORITY|||||||0.48||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.48
73859001|NCT01444027|147263498|SUPERIORITY|||||||0.01||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||.01
73859002|NCT01444027|147263499|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
73859003|NCT01444027|147263499|SUPERIORITY|||||||0.83|||||||Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.83
73859004|NCT01444027|147263499|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
73859005|NCT01444027|147263500|SUPERIORITY|||||||0.003||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.003
73859006|NCT01444027|147263500|SUPERIORITY|||||||0.16||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.16
73859007|NCT01444027|147263500|SUPERIORITY|||||||0.17||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.17
73859008|NCT01444027|147263501|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
73859009|NCT01444027|147263501|SUPERIORITY|||||||0.78||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.78
73859010|NCT01444027|147263501|SUPERIORITY|||||||0.004||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.004
73859011|NCT00953680|147263545|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.993||||||90.0|0.95|1.039||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.039|0.950|
73859012|NCT00953680|147263546|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.835||||||90.0|0.749|0.931||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100-mg tablet + HCTZ 12.5 mg capsule||0.931|0.749|
73859013|NCT00953680|147263547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.924||||||90.0|0.825|1.035||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.035|0.825|
73859014|NCT00953680|147263548|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.931||||||90.0|0.836|1.037||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.037|0.836|
73859015|NCT00737711|147263568|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Paired t-test was used to estimation of p-value.|t-test, 2 sided|||||||<0.0001
73863243|NCT02636946|147272688|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.3928|TWO_SIDED|95.0|-0.81|0.32|||MMRM|||Change from Baseline at Week 24: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% confidence interval (CI) was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||0.32|-0.81|0.3928
73863244|NCT01792518|147272717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.78|-0.43|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change in HbA1c is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline HbA1c by visit and baseline log10 (UACR) by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.||-0.43|-0.78|<0.0001
73863245|NCT01792518|147272718|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.94||||0.1954|TWO_SIDED|95.0|0.85|1.03|||ANCOVA||Ratio of relative change for Linagliptin 5 mg over placebo is presented.|Superiority of Linagliptin 5 mg vs. placebo: change in UACR is analysed using analysis of covariance model. Model includes baseline HbA1c and baseline log10 (UACR) as linear covariates and treatment as fixed effect.||1.03|0.85|0.1954
73863246|NCT01792518|147272719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|2.7||0.3306|TWO_SIDED|95.0|-7.95|2.68|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Change in eGFR is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline eGFR, baseline HbA1c by visit, baseline log10 (UACR) by visit and baseline eGFR by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.||2.68|-7.95|0.3306
73863247|NCT00915148|147272721|SUPERIORITY_OR_OTHER||||||<|0.01||||||The reported p-value corresponds with each area under the ROC assessments|Chi-squared|||In a previous study we investigated women before induction of labor. Using 40 mm as cut-off level for fetal head - perineum distance, the Cesarean section rate in primiparous women was 7% in the group with a short distance and 27% in the group with a long distance. We assumed similar results, with alpha 0.05, power 0.8 and a ratio of 1 : 1 for the numbers of women with a long and short distance. We would need to include 110 women in the study.||||<0.01
74026897|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.47|0.76|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.76|0.47|
73859016|NCT04545047|147263596|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-2.3|3.6||||||The investigators estimated the 30-day mortality risk difference comparing patients assigned to each group. Adjustment for covariates would be carried out via inverse probability weighting.||3.60|-2.30|
73859017|NCT04545047|147263596|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.64|1.62||||||The investigators estimated the 30-day mortality hazard ratio comparing patients assigned to each group. The hazard ratio was estimated from pooled logistic models with inverse probability weighting to adjust for confounding.||1.62|0.64|
73859018|NCT01514240|147263602|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 90% CI for the observed difference in the primary outcome measure (remission rate) between the D9421-C 9mg group and the Mesalazine 3 g group was calculated at week 8 using the Newcombe-Wilson score method without continuity correction. Noninferiority was concluded if the lower limit of the 90% CI was higher than -10% in FAS Population.|Difference of proportion|5.4||||0.526|TWO_SIDED|90.0|-8.49|18.94|||Chi-squared|||The primary objective of this study was to determine non-inferiority in the differences in remission rates at Week 8 for D9421-C 9 mg as compared to Mesalazine 3 g.||18.94|-8.49|0.526
73859019|NCT01514240|147263603|SUPERIORITY_OR_OTHER||Difference of proportion|1.8||||0.768|TWO_SIDED|90.0|-8.54|12.15|||Chi-squared||Differences in remission rate at Week 2 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction|||12.15|-8.54|0.768
73859020|NCT01514240|147263604|SUPERIORITY_OR_OTHER||Difference of proportion|8.9||||0.208|TWO_SIDED|90.0|-2.87|20.58|||Chi-squared||Differences in remission rate at Week 4 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction|||20.58|-2.87|0.208
73859021|NCT01514240|147263605|SUPERIORITY_OR_OTHER||LS mean difference between group|-22.8|STANDARD_ERROR_OF_MEAN|11.89||0.058|TWO_SIDED|90.0|-42.55|-3.09|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||-3.09|-42.55|0.058
73859022|NCT01514240|147263606|SUPERIORITY_OR_OTHER||LS mean difference between group|-30.0|STANDARD_ERROR_OF_MEAN|12.05||0.014|TWO_SIDED|90.0|-49.95|-9.96|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||-9.96|-49.95|0.014
73859023|NCT01514240|147263607|SUPERIORITY_OR_OTHER||LS mean difference between group|-21.4|STANDARD_ERROR_OF_MEAN|14.53||0.144|TWO_SIDED|90.0|-45.47|2.74|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.74|-45.47|0.144
73859024|NCT01514240|147263611|SUPERIORITY_OR_OTHER||Difference of proportions|14.3|||||TWO_SIDED|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||27.40|0.50|
73859025|NCT01514240|147263612|SUPERIORITY_OR_OTHER||Difference of proportions|16.1|||||TWO_SIDED|90.0|1.66|29.61|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||29.61|1.66|
73859026|NCT01514240|147263613|SUPERIORITY_OR_OTHER||Difference of proportions|16.1|||||TWO_SIDED|90.0|0.85|30.29|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||30.29|0.85|
73859027|NCT01514240|147263614|SUPERIORITY_OR_OTHER||Difference of proportions|7.1|||||TWO_SIDED|90.0|-5.67|19.71|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||19.71|-5.67|
73859028|NCT01514240|147263615|SUPERIORITY_OR_OTHER||Difference of proportions|14.3|||||TWO_SIDED|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||27.40|0.50|
73859029|NCT01514240|147263616|SUPERIORITY_OR_OTHER||Difference of proportions|12.5|||||TWO_SIDED|90.0|-2.44|26.68|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||26.68|-2.44|
73859030|NCT01514240|147263617|SUPERIORITY_OR_OTHER||LS mean difference between group|10.5|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|90.0|4.86|16.14|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||16.14|4.86|
73859031|NCT01514240|147263618|SUPERIORITY_OR_OTHER||LS mean difference between group|12.6|STANDARD_ERROR_OF_MEAN|3.93|||TWO_SIDED|90.0|6.07|19.11|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||19.11|6.07|
73859032|NCT01514240|147263619|SUPERIORITY_OR_OTHER||LS mean difference between group|12.6|STANDARD_ERROR_OF_MEAN|4.31|||TWO_SIDED|90.0|5.4|19.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||19.72|5.40|
73859033|NCT01514240|147263620|SUPERIORITY_OR_OTHER||LS mean difference between group|14.1|STANDARD_ERROR_OF_MEAN|4.32|||TWO_SIDED|90.0|6.9|21.23|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||21.23|6.90|
73913740|NCT04115839|147357226|SUPERIORITY||Difference in response rates|9.1|||||TWO_SIDED|95.0|-3.7|21.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.9|-3.7|
73913741|NCT04115839|147357242|SUPERIORITY||Difference in response rates|9.5|||||TWO_SIDED|95.0|-10.4|29.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||29.4|-10.4|
73913742|NCT04115839|147357242|SUPERIORITY||Difference in response rates|7.1|||||TWO_SIDED|95.0|-12.5|26.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||26.7|-12.5|
73913743|NCT04115839|147357242|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-3.8|43.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||43.8|-3.8|
73913744|NCT04115839|147357242|SUPERIORITY||Difference in response rates|6.5|||||TWO_SIDED|95.0|-16.3|29.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||29.3|-16.3|
73913745|NCT04115839|147357242|SUPERIORITY||Difference in response rates|17.8|||||TWO_SIDED|95.0|-8.8|44.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||44.5|-8.8|
73913746|NCT04115839|147357242|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-22.9|28.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||28.8|-22.9|
73913747|NCT04115839|147357242|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-0.5|50.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||50.6|-0.5|
73913748|NCT04115839|147357242|SUPERIORITY||Difference in response rates|14.7|||||TWO_SIDED|95.0|-10.5|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||39.9|-10.5|
73913749|NCT04115839|147357242|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-8.7|45.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||45.6|-8.7|
73913750|NCT04115839|147357242|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-20.5|32.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||32.6|-20.5|
73913751|NCT04115839|147357244|SUPERIORITY||Difference in response rates|9.0|||||TWO_SIDED|95.0|-6.0|23.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||23.9|-6.0|
73913752|NCT04115839|147357244|SUPERIORITY||Difference in response rates|3.3|||||TWO_SIDED|95.0|-9.4|15.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||15.9|-9.4|
73913753|NCT04115839|147357244|SUPERIORITY||Difference in response rates|5.7|||||TWO_SIDED|95.0|-14.7|26.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||26.2|-14.7|
73913754|NCT04115839|147357244|SUPERIORITY||Difference in response rates|-5.5|||||TWO_SIDED|95.0|-23.4|12.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||12.4|-23.4|
73913755|NCT04115839|147357244|SUPERIORITY||Difference in response rates|1.3|||||TWO_SIDED|95.0|-21.5|24.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||24.1|-21.5|
73913756|NCT04115839|147357244|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.2|22.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.2|-22.2|
73913757|NCT04115839|147357244|SUPERIORITY||Difference in response rates|21.6|||||TWO_SIDED|95.0|-0.8|43.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||43.9|-0.8|
73913758|NCT04115839|147357244|SUPERIORITY||Difference in response rates|20.6|||||TWO_SIDED|95.0|-1.4|42.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||42.6|-1.4|
73913759|NCT04115839|147357244|SUPERIORITY||Difference in response rates|17.5|||||TWO_SIDED|95.0|-7.7|42.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||42.7|-7.7|
73913760|NCT04115839|147357244|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-20.2|26.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||26.3|-20.2|
73913761|NCT04115839|147357247|SUPERIORITY||Difference in response rates|9.3|||||TWO_SIDED|95.0|-9.2|27.8||||||Week 2||27.8|-9.2|
73913762|NCT04115839|147357247|SUPERIORITY||Difference in response rates|3.8|||||TWO_SIDED|95.0|-13.5|21.0||||||Week 2||21.0|-13.5|
73913763|NCT04115839|147357247|SUPERIORITY||Difference in response rates|5.7|||||TWO_SIDED|95.0|-16.8|28.2||||||Week 4||28.2|-16.8|
73913764|NCT04115839|147357247|SUPERIORITY||Difference in response rates|-2.4|||||TWO_SIDED|95.0|-23.7|19.0||||||Week 4||19.0|-23.7|
73913765|NCT04115839|147357247|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-21.1|31.8||||||Week 8||31.8|-21.1|
73913766|NCT04115839|147357247|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-31.0|19.3||||||Week 8||19.3|-31.0|
73913767|NCT04115839|147357247|SUPERIORITY||Difference in response rates|19.2|||||TWO_SIDED|95.0|-7.0|45.3||||||Week 12||45.3|-7.0|
73913768|NCT04115839|147357247|SUPERIORITY||Difference in response rates|8.8|||||TWO_SIDED|95.0|-16.9|34.6||||||Week 12||34.6|-16.9|
73913769|NCT04115839|147357247|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-8.7|45.6||||||Week 16||45.6|-8.7|
73913770|NCT04115839|147357247|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-23.4|29.5||||||Week 16||29.5|-23.4|
73913771|NCT04115839|147357249|SUPERIORITY||Difference in response rates|-2.8|||||TWO_SIDED|95.0|-11.0|5.4||||||Week 2||5.4|-11.0|
73913772|NCT04115839|147357249|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-10.6|11.1||||||Week 2||11.1|-10.6|
73913773|NCT04115839|147357249|SUPERIORITY||Difference in response rates|-2.9|||||TWO_SIDED|95.0|-15.2|9.5||||||Week 4||9.5|-15.2|
73913774|NCT04115839|147357249|SUPERIORITY||Difference in response rates|-5.7|||||TWO_SIDED|95.0|-16.3|4.9||||||Week 4||4.9|-16.3|
73913775|NCT04115839|147357249|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-16.4|17.5||||||Week 8||17.5|-16.4|
73913776|NCT04115839|147357249|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-19.9|8.2||||||Week 8||8.2|-19.9|
73913777|NCT04115839|147357249|SUPERIORITY||Difference in response rates|12.2|||||TWO_SIDED|95.0|-4.3|28.7||||||Week 12||28.7|-4.3|
73913778|NCT04115839|147357249|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-9.7|15.6||||||Week 12||15.6|-9.7|
73913779|NCT04115839|147357249|SUPERIORITY||Difference in response rates|13.1|||||TWO_SIDED|95.0|-4.2|30.4||||||Week 16||30.4|-4.2|
73913780|NCT04115839|147357249|SUPERIORITY||Difference in response rates|12.1|||||TWO_SIDED|95.0|-4.5|28.7||||||Week 16||28.7|-4.5|
74026898|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|0.87|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.87|0.67|
74026899|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.30|0.96|
74026900|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.02|0.75|
74026901|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.48|
74026902|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.46|0.32|
74026903|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|0.94|1.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.75|0.94|
74026904|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.32|2.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.19|1.32|
74085696|NCT03244475|147725630|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.|Mean Difference (Final Values)|1.6||||0.01|TWO_SIDED|95.0|1.1|2.2||The corrected p-value of 0.01 was chosen after the standard cluster analysis for correcting family-wise error across different voxels.|Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||The analysis was performed for the voxel-wise delta-band activity from the frontal pole and inferior frontal gyri. Spatial smoothing and logarithm transformation (e-based) were performed. Resting-state MEG activity differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||2.2|1.1|0.01
74085697|NCT03244475|147725631|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
73859034|NCT01514240|147263621|SUPERIORITY_OR_OTHER||LS mean difference between group|3.4|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|1.49|5.29|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.29|1.49|
74026905|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.14|1.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.60|1.14|
73859035|NCT01514240|147263622|SUPERIORITY_OR_OTHER||LS mean difference between group|3.8|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|1.64|5.97|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.97|1.64|
73859036|NCT01514240|147263623|SUPERIORITY_OR_OTHER||LS mean difference between group|4.1|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|90.0|1.58|6.64|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||6.64|1.58|
73859037|NCT01514240|147263624|SUPERIORITY_OR_OTHER||LS mean difference between group|3.3|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|90.0|0.9|5.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.76|0.90|
73913781|NCT04115839|147357252|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-3.8|40.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||40.7|-3.8|
74026906|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.2|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.01|1.20|
74026907|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.24|2.26|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.26|1.24|
74085698|NCT03244475|147725632|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
74085699|NCT03244475|147725633|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
74085700|NCT03244475|147725634|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
73913782|NCT04115839|147357252|SUPERIORITY||Difference in response rates|7.3|||||TWO_SIDED|95.0|-13.5|28.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||28.2|-13.5|
74026908|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.26|4.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||4.30|2.26|
74026909|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.0|||||TWO_SIDED|95.0|1.53|2.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.75|1.53|
74026910|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.48|2.95|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.95|1.48|
74026911|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.7|||||TWO_SIDED|95.0|1.97|3.7|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.70|1.97|
74026912|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.9|||||TWO_SIDED|95.0|1.99|4.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||4.29|1.99|
74026913|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.23|2.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.05|1.23|
74026914|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.18|1.78|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.78|1.18|
74085701|NCT03244475|147725635|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
74085702|NCT03244475|147725636|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
73859038|NCT01514240|147263625|SUPERIORITY_OR_OTHER||LS mean difference between group|2.0|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|0.89|3.17|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.17|0.89|
73859039|NCT01514240|147263626|SUPERIORITY_OR_OTHER||LS mean difference between group|2.0|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|0.73|3.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.19|0.73|
73913783|NCT04115839|147357252|SUPERIORITY||Difference in response rates|16.0|||||TWO_SIDED|95.0|-8.5|40.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||40.4|-8.5|
73913784|NCT04115839|147357252|SUPERIORITY||Difference in response rates|15.5|||||TWO_SIDED|95.0|-9.4|40.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||40.3|-9.4|
73913785|NCT04115839|147357252|SUPERIORITY||Difference in response rates|18.8|||||TWO_SIDED|95.0|-7.5|45.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||45.0|-7.5|
73913786|NCT04115839|147357252|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-32.5|20.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||20.7|-32.5|
73913787|NCT04115839|147357252|SUPERIORITY||Difference in response rates|40.5|||||TWO_SIDED|95.0|15.8|65.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||65.2|15.8|
73913788|NCT04115839|147357252|SUPERIORITY||Difference in response rates|23.5|||||TWO_SIDED|95.0|-2.5|49.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||49.5|-2.5|
73913789|NCT04115839|147357252|SUPERIORITY||Difference in response rates|20.1|||||TWO_SIDED|95.0|-6.8|46.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||46.9|-6.8|
73913790|NCT04115839|147357252|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-21.0|33.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.1|-21.0|
73913791|NCT04115839|147357256|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-31.0|31.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||31.0|-31.0|
73913792|NCT04115839|147357256|SUPERIORITY||Difference in response rates|22.0|||||TWO_SIDED|95.0|-12.8|56.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||56.7|-12.8|
73913793|NCT04115839|147357256|SUPERIORITY||Difference in response rates|4.3|||||TWO_SIDED|95.0|-37.9|46.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.5|-37.9|
74026915|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.04|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.04|
73913794|NCT04115839|147357256|SUPERIORITY||Difference in response rates|5.5|||||TWO_SIDED|95.0|-35.4|46.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.3|-35.4|
73913795|NCT04115839|147357256|SUPERIORITY||Difference in response rates|17.1|||||TWO_SIDED|95.0|-25.6|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-25.6|
73913796|NCT04115839|147357256|SUPERIORITY||Difference in response rates|-13.4|||||TWO_SIDED|95.0|-53.7|26.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||26.8|-53.7|
73913797|NCT04115839|147357256|SUPERIORITY||Difference in response rates|28.6|||||TWO_SIDED|95.0|-14.1|71.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||71.2|-14.1|
73913798|NCT04115839|147357256|SUPERIORITY||Difference in response rates|-0.4|||||TWO_SIDED|95.0|-40.8|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||39.9|-40.8|
73913799|NCT04115839|147357258|SUPERIORITY||Difference in response rates|6.7||||0.55|TWO_SIDED|95.0|-21.3|34.7||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||34.7|-21.3|0.55
73913800|NCT04115839|147357258|SUPERIORITY||Difference in response rates|11.0||||0.24|TWO_SIDED|95.0|-17.4|39.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||39.3|-17.4|0.24
73913801|NCT04115839|147357258|SUPERIORITY||Difference in response rates|6.2||||0.47|TWO_SIDED|95.0|-22.6|35.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||35.0|-22.6|0.47
74026916|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.19|0.82|
74026917|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.29|0.96|
73913802|NCT04115839|147357258|SUPERIORITY||Difference in response rates|10.5||||0.25|TWO_SIDED|95.0|-18.6|39.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||39.6|-18.6|0.25
73913803|NCT04115839|147357258|SUPERIORITY||Difference in response rates|18.6||||0.44|TWO_SIDED|95.0|-21.1|58.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||58.3|-21.1|0.44
73859040|NCT01514240|147263627|SUPERIORITY_OR_OTHER||LS mean difference between group|2.4|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|0.96|3.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.76|0.96|
73859041|NCT01514240|147263628|SUPERIORITY_OR_OTHER||LS mean difference between group|2.6|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|90.0|1.15|4.09|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||4.09|1.15|
73859042|NCT01514240|147263629|SUPERIORITY_OR_OTHER||LS mean difference between group|3.8|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|90.0|1.44|6.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||6.19|1.44|
73859043|NCT01514240|147263630|SUPERIORITY_OR_OTHER||LS mean difference between group|4.9|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|90.0|2.14|7.65|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||7.65|2.14|
73859044|NCT01514240|147263631|SUPERIORITY_OR_OTHER||LS mean difference between group|4.3|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|1.4|7.25|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||7.25|1.40|
73859045|NCT01514240|147263632|SUPERIORITY_OR_OTHER||LS mean difference between group|6.6|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|3.56|9.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||9.72|3.56|
73859046|NCT01514240|147263633|SUPERIORITY_OR_OTHER||LS mean difference between group|1.2|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|0.01|2.43|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.43|0.01|
73859047|NCT01514240|147263634|SUPERIORITY_OR_OTHER||LS mean difference between group|1.8|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|90.0|0.42|3.12|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.12|0.42|
73859048|NCT01514240|147263635|SUPERIORITY_OR_OTHER||LS mean difference between group|1.6|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|0.19|3.04|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.04|0.19|
73859049|NCT01514240|147263636|SUPERIORITY_OR_OTHER||LS mean difference between group|1.3|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|90.0|-0.15|2.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.76|-0.15|
73859050|NCT01103063|147263637|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.11|STANDARD_DEVIATION|0.0647||0.12237|TWO_SIDED|95.0|0.97|1.25||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.25|0.97|0.12237
73859051|NCT01103063|147263638|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|STANDARD_DEVIATION|0.1243||0.84117|TWO_SIDED|95.0|0.8|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.31|0.80|0.84117
73859052|NCT01103063|147263639|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87|STANDARD_DEVIATION|0.1745||0.4428|TWO_SIDED|95.0|0.62|1.23||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.23|0.62|0.4428
73859053|NCT01103063|147263640|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91|STANDARD_DEVIATION|0.1882||0.6086|TWO_SIDED|95.0|0.63|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.31|0.63|0.6086
73859054|NCT01103063|147263641|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|STANDARD_DEVIATION|0.2866||0.7035|TWO_SIDED|95.0|0.51|1.57||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.57|0.51|0.7035
73863248|NCT00915148|147272722|SUPERIORITY_OR_OTHER||||||<|0.01||||||the reported p-value corresponds with each log rank comparison|Log Rank|||"Kaplan Meier plots were used to compare time from a defined prolonged labor in the first stage to delivery for~1. women with fetal head-perineum distance ≤40 mm vs. women with distance \>40 mm measured with 2D ultrasound.~2. women with angle of progression ≥110 degrees vs. women with angle \<110 degrees measured with 2D ultrasound"||||<0.01
73913804|NCT04115839|147357258|SUPERIORITY||Difference in response rates|-3.8||||0.68|TWO_SIDED|95.0|-38.4|30.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||30.8|-38.4|0.68
73913805|NCT04115839|147357258|SUPERIORITY||Difference in response rates|21.4||||0.33|TWO_SIDED|95.0|-19.4|62.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||62.2|-19.4|0.33
73913806|NCT04115839|147357258|SUPERIORITY||Difference in response rates|2.1||||0.98|TWO_SIDED|95.0|-33.9|38.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||38.1|-33.9|0.98
73913807|NCT04115839|147357260|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.5|24.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||24.5|-24.5|
73913808|NCT04115839|147357260|SUPERIORITY||Difference in response rates|-0.8|||||TWO_SIDED|95.0|-23.9|22.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.4|-23.9|
73913809|NCT04115839|147357260|SUPERIORITY||Difference in response rates|13.3|||||TWO_SIDED|95.0|-10.8|37.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||37.4|-10.8|
74026918|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.89|1.2|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.20|0.89|
74026919|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|1.07|
73913810|NCT04115839|147357260|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||23.6|-11.8|
73913811|NCT04115839|147357260|SUPERIORITY||Difference in response rates|-14.8|||||TWO_SIDED|95.0|-46.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||17.1|-46.6|
74026920|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.24|1.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.61|1.24|
74026921|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.27|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.27|0.96|
73913812|NCT04115839|147357260|SUPERIORITY||Difference in response rates|-15.5|||||TWO_SIDED|95.0|-46.3|15.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||15.2|-46.3|
73913813|NCT04115839|147357260|SUPERIORITY||Difference in response rates|21.4|||||TWO_SIDED|95.0|-13.0|55.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||55.8|-13.0|
73913814|NCT04115839|147357260|SUPERIORITY||Difference in response rates|4.6|||||TWO_SIDED|95.0|-22.3|31.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||31.5|-22.3|
73913815|NCT04115839|147357262|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-6.7|6.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||6.7|-6.7|
73913816|NCT04115839|147357262|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.6|23.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||23.3|-11.6|
73913817|NCT04115839|147357262|SUPERIORITY||Difference in response rates|6.7|||||TWO_SIDED|95.0|-12.9|26.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||26.2|-12.9|
73913818|NCT04115839|147357262|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||23.6|-11.8|
73913819|NCT04115839|147357262|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-6.9|6.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||6.9|-6.9|
73913820|NCT04115839|147357262|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||23.6|-11.8|
73913821|NCT04115839|147357262|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-7.1|7.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||7.1|-7.1|
73913822|NCT04115839|147357262|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||23.6|-11.8|
73913823|NCT04115839|147357270|SUPERIORITY||LS Mean Treatment Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.066||0.19|TWO_SIDED|95.0|-0.22|0.04||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 2||0.04|-0.22|0.19
73859055|NCT01103063|147263642|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|STANDARD_DEVIATION|0.04||0.4605|TWO_SIDED|95.0|0.95|1.11||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.11|0.95|0.4605
74026922|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rises|2.1|||||TWO_SIDED|95.0|1.56|2.8|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.80|1.56|
73859056|NCT01103063|147263643|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|STANDARD_DEVIATION|0.1817||0.7105|TWO_SIDED|95.0|0.65|1.33||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.33|0.65|0.7105
73859057|NCT01103063|147263644|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|STANDARD_DEVIATION|0.1842||0.3468|TWO_SIDED|95.0|0.59|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.21|0.59|0.3468
73859058|NCT01103063|147263645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0011|TWO_SIDED|95.0|-0.08|-0.02||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of STIs).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.02|-0.08|0.0011
73859059|NCT01103063|147263646|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|STANDARD_DEVIATION|0.0604||0.2265|TWO_SIDED|95.0|0.96|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.21|0.96|0.2265
74026923|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.3|||||TWO_SIDED|95.0|1.82|2.88|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.88|1.82|
74026924|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.18|1.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.90|1.18|
74026925|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.48|0.89|
74026926|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.63|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.85|0.63|
73859060|NCT01103063|147263647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0131|TWO_SIDED|95.0|-0.24|-0.03||Analysis based on an ANCOVA model with model terms for baseline value, treatment group and randomization stratification variable.|ANCOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.03|-0.24|0.0131
74026927|NCT01025336|147607522|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|0.99|1.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.51|0.99|
74026928|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.31|1.03|
74026929|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.16|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.16|0.91|
73913824|NCT04115839|147357270|SUPERIORITY||LS Mean Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.067||0.84|TWO_SIDED|95.0|-0.15|0.12||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 2||0.12|-0.15|0.84
73965531|NCT05107401|147466592|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.083|TWO_SIDED|95.0|-4.9|0.3|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.30|-4.90|0.083
73965532|NCT05107401|147466593|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.032|TWO_SIDED|95.0|-1.16|-0.18|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, age, sex at birth, and sexual orientation.||-0.18|-1.16|0.032
73965533|NCT05107401|147466594|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.48|TWO_SIDED|95.0|-0.72|0.29|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.29|-0.72|0.48
73965534|NCT05107401|147466595|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.48|TWO_SIDED|95.0|-1.49|0.29|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.29|-1.49|0.48
74026930|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.37|1.07|
74026931|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.13|0.91|
73913825|NCT04115839|147357270|SUPERIORITY||LS Mean Treatment Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.073||0.3|TWO_SIDED|95.0|-0.22|0.07||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0.07|-0.22|0.30
73913826|NCT04115839|147357270|SUPERIORITY||LS Mean Treatment Difference|0.01|STANDARD_ERROR_OF_MEAN|0.074||0.89|TWO_SIDED|95.0|-0.14|0.16||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0.16|-0.14|0.89
73913827|NCT04115839|147357270|SUPERIORITY||LS Mean Treatment Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.096||0.064|TWO_SIDED|95.0|-0.37|0.01||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||0.01|-0.37|0.064
74026932|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.6|2.68|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.68|1.60|
73913828|NCT04115839|147357270|SUPERIORITY||LS Mean Treatment Difference|0.01|STANDARD_ERROR_OF_MEAN|0.096||0.88|TWO_SIDED|95.0|-0.17|0.2||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||0.20|-0.17|0.88
73913829|NCT04115839|147357270|SUPERIORITY||LS Mean Treatment Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.099||0.023|TWO_SIDED|95.0|-0.43|-0.03||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||-0.03|-0.43|0.023
73913830|NCT04115839|147357270|SUPERIORITY||LS Mean Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.099||0.75|TWO_SIDED|95.0|-0.23|0.17||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||0.17|-0.23|0.75
73913831|NCT04115839|147357270|SUPERIORITY||LS Mean Treatment Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.106||0.005|TWO_SIDED|95.0|-0.51|-0.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||-0.10|-0.51|0.005
74085703|NCT03244475|147725637|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
73913832|NCT04115839|147357270|SUPERIORITY||LS Mean Treatment Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.105||0.54|TWO_SIDED|95.0|-0.27|0.14||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||0.14|-0.27|0.54
73913833|NCT04115839|147357272|SUPERIORITY||LS Mean Treatment Difference|1.3|STANDARD_ERROR_OF_MEAN|1.64||0.43|TWO_SIDED|95.0|-1.9|4.5||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||4.5|-1.9|0.43
73913834|NCT04115839|147357272|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.64||0.81|TWO_SIDED|95.0|-3.6|2.9||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||2.9|-3.6|0.81
73913835|NCT04115839|147357272|SUPERIORITY||LS Mean Treatment Difference|5.1|STANDARD_ERROR_OF_MEAN|2.43||0.04|TWO_SIDED|95.0|0.2|9.9||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||9.9|0.2|0.040
73913836|NCT04115839|147357272|SUPERIORITY||LS Mean Treatment Difference|1.4|STANDARD_ERROR_OF_MEAN|2.41||0.58|TWO_SIDED|95.0|-3.4|6.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||6.1|-3.4|0.58
73913837|NCT04115839|147357276|SUPERIORITY||LS Mean Treatment Difference|0.9|STANDARD_ERROR_OF_MEAN|1.09||0.4|TWO_SIDED|95.0|-1.2|3.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||3.1|-1.2|0.40
74026933|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.4|||||TWO_SIDED|95.0|1.82|3.24|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.24|1.82|
74026934|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.55|2.03|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.03|1.55|
74026935|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.54|2.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.09|1.54|
74026936|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.07|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.07|0.79|
74026937|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.48|2.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.55|1.48|
74026938|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.53|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.53|1.05|
74026939|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.5|2.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.51|1.50|
74026940|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.6|||||TWO_SIDED|95.0|1.98|3.5|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.50|1.98|
74026941|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.31|2.18|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.18|1.31|
74026942|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.37|2.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.61|1.37|
74026943|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.4|||||TWO_SIDED|95.0|1.76|3.38|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.38|1.76|
74026944|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.33|1.86|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.86|1.33|
74026945|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.38|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.01|1.38|
74026946|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.1|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.10|
74026947|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.55|1.14|
74026948|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.14|
74026949|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.28|1.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.67|1.28|
73913838|NCT04115839|147357276|SUPERIORITY||LS Mean Treatment Difference|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.28|TWO_SIDED|95.0|-1.0|3.4||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||3.4|-1.0|0.28
73913839|NCT04115839|147357276|SUPERIORITY||LS Mean Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|1.46||0.011|TWO_SIDED|95.0|0.9|6.7||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||6.7|0.9|0.011
74026950|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.2|||||TWO_SIDED|95.0|1.8|2.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.60|1.80|
74026951|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.53|2.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.31|1.53|
74026952|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.44|2.06|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.06|1.44|
74026953|NCT01025336|147607523|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.24|1.84|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.84|1.24|
74026954|NCT01025336|147607524|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
74026955|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
74026956|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.2|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.29|0.20|
73913840|NCT04115839|147357276|SUPERIORITY||LS Mean Treatment Difference|2.1|STANDARD_ERROR_OF_MEAN|1.45||0.14|TWO_SIDED|95.0|-0.7|5.0||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||5.0|-0.7|0.14
74026957|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.2|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.30|0.20|
74026958|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.42|0.31|
74026959|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.18|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.26|0.18|
74026960|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.18|0.10|
74026961|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.12|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.20|0.12|
73913841|NCT02577510|147357280|OTHER|||||||0.05|||||||t-test, 1 sided|||Statistical analysis was performed using SPSS Version 21 statistical software (IBM, Armonk, New York). For continuous data, normality was fi rst assessed with the Lilliefors test and then analyzed using a paired t test. Data that did not have a normal distribution, as well as ordinal data, was analyzed using Wilcoxon's signed ranks or McNemar's test. All P values presented were 2-sided and values inferior to 0.05 were considered signifi cant||||0.05
73913842|NCT00590720|147357305|SUPERIORITY_OR_OTHER|||||||0.4|||||||Two-sample t-test|||||||0.40
73913843|NCT00590720|147357306|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Two-sample t-test|||||||<0.01
73913844|NCT00590720|147357307|SUPERIORITY_OR_OTHER|||||||0.53|||||||Two-sample t-test|||||||0.53
73965535|NCT05107401|147466596|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.37|TWO_SIDED|95.0|-2.6|0.51|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.51|-2.60|0.37
74026962|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.18|0.10|
74026963|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.13|0.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.22|0.13|
74026964|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
73913845|NCT00590720|147357308|SUPERIORITY_OR_OTHER|||||||0.22|||||||Two-sample t-test|||||||0.22
73913846|NCT00590720|147357309|SUPERIORITY_OR_OTHER|||||||0.16|||||||Two-sample t-test|||||||0.16
73913847|NCT00590720|147357310|SUPERIORITY_OR_OTHER|||||||0.52|||||||Two-sample t-test|||||||0.52
73913848|NCT01619423|147357331|SUPERIORITY||Odds Ratio (OR)|0.78||||0.31|ONE_SIDED|10.0||1.5|||Cochran-Mantel-Haenszel|||||1.5||0.31
73913849|NCT01619423|147357331|SUPERIORITY||Odds Ratio (OR)|0.55||||0.15|ONE_SIDED|10.0||1.16|||Cochran-Mantel-Haenszel|||||1.16||0.15
73913850|NCT01619423|147357331|SUPERIORITY||Odds Ratio (OR)|0.62||||0.16|ONE_SIDED|10.0||1.14|||Cochran-Mantel-Haenszel|||||1.14||0.16
73913851|NCT02002091|147357336|OTHER|||||||0.706|||||||Chi-squared|||||||0.706
73913852|NCT02002091|147357337|OTHER|||||||0.346|||||||Chi-squared|||||||0.346
73913853|NCT02002091|147357338|OTHER|||||||0.123|||||||Mantel Haenszel|||||||0.123
73913854|NCT02002091|147357339|OTHER|||||||0.968|||||||Chi-squared, Corrected|||||||0.968
73913855|NCT02002091|147357340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The threshold for statistical significance for P-Value is \<0.05|Fisher Exact|||||||0.004
73913856|NCT02002091|147357341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.988|||||||Fisher Exact|||||||0.988
73913857|NCT02002091|147357342|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||Fisher Exact|||||||0.038
73913858|NCT02002091|147357344|SUPERIORITY_OR_OTHER_LEGACY|||||||0.917|||||||Chi-squared, Corrected|||||||0.917
73913859|NCT02002091|147357345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.816|||||||Chi-squared, Corrected|||||||0.816
73913860|NCT02002091|147357346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Statistical significance : p\< 0.05|Fisher Exact|||||||0.008
73913861|NCT02002091|147357348|OTHER|||||||0.025||||||The threshold of statistical difference is P-value \< 0.05|Chi-squared, Corrected|||||||0.025
73913862|NCT02002091|147357351|OTHER|||||||0.059||||||the threshold for statistical significance used is P-value \<0.05|Fisher Exact|||||||0.059
73913863|NCT03385564|147357365|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|-5.68||||0.7957|TWO_SIDED|80.0|-34.192|22.825|||Regression, Logistic||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||22.825|-34.192|0.7957
73913864|NCT03385564|147357365|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|-9.37||||0.5811|TWO_SIDED|80.0|-31.178|12.44|||Regression, Logistic||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||12.440|-31.178|0.5811
74026965|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.25|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.38|0.25|
74026966|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.08|0.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.14|0.08|
74026967|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.06|0.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.10|0.06|
74026968|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.46|0.22|
74026969|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.60|0.40|
74085704|NCT03244475|147725638|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
74085705|NCT03244475|147725639|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
74085706|NCT03244475|147725640|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
74085707|NCT03244475|147725641|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
74026970|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.43|0.29|
74026971|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.59|0.29|
74085708|NCT01844531|147725642|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|97.92|STANDARD_ERROR_OF_MEAN|8.4||0|TWO_SIDED|90.0|93.529|102.52||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||102.520|93.529|0.0000
74088373|NCT03694808|147730162|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference of proportions|-0.113|||||TWO_SIDED|95.0|-0.241|0.015|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.015|-0.241|
74026972|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.17|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.38|0.17|
74026973|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.21|0.36|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.36|0.21|
74026974|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.27|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.56|0.27|
74026975|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.13|0.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.28|0.13|
74026976|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.2|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.39|0.20|
74026977|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.28|0.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.67|0.28|
73913865|NCT03385564|147357365|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|1.97||||0.8972|TWO_SIDED|80.0|-17.534|21.48|||Regression, Logistic||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||21.480|-17.534|0.8972
73913866|NCT03385564|147357366|OTHER||Difference|-9.14||||0.825|TWO_SIDED|80.0|-32.83|17.02|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||17.02|-32.83|0.8250
74026978|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.83|0.48|
74026979|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.74|0.49|
74026980|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.65|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.65|0.42|
74026981|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.2|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.32|0.20|
74085709|NCT01844531|147725642|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.0|STANDARD_ERROR_OF_MEAN|8.3|<|0.0001|TWO_SIDED|90.0|93.57|102.65||Model included effects:sequence;subjects within sequences;period and treatment with all effects as fixed.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||102.65|93.57|<.0001
74088374|NCT00118378|147730172|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||< 0.001
74088375|NCT00118378|147730173|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.001
73913867|NCT03385564|147357366|OTHER||Difference|-21.23||||0.2562|TWO_SIDED|80.0|-39.44|0.51|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||0.51|-39.44|0.2562
73913868|NCT03385564|147357366|OTHER||Difference|-2.0||||0.9632|TWO_SIDED|80.0|-20.45|16.62|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||16.62|-20.45|0.9632
74026982|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.43|0.28|
74026983|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.45|0.29|
74088376|NCT00118378|147730174|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|95.0|||||ANOVA|||Week 4 CD4 cell count||||.150
73859061|NCT01103063|147263648|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|STANDARD_DEVIATION|0.2694||0.6978|TWO_SIDED|95.0|0.53|1.53||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.53|0.53|0.6978
73965536|NCT05107401|147466597|SUPERIORITY||Risk Ratio (RR)|1.13||||0.099|TWO_SIDED|95.0|0.98|1.32|||Regression, Logistic||The statistical values presented are the relative risk between study arms at the three-month follow-up.|We used a generalized linear model using a binomial distribution to examine whether the intervention was associated with increased HIV self-testing uptake in the follow-up period. The model was adjusted for history of HIV testing (pre-intervention testing and testing prior to the study), whether the participant had submitted content to the JasSpark contest, and if the participant had a main intimate partner (e.g., girlfriend/boyfriend, spouse).||1.32|0.98|0.099
74088377|NCT00118378|147730175|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED|95.0|||||ANOVA|||||||.459
73859062|NCT01103063|147263649|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.14|STANDARD_DEVIATION|0.2908||0.6542|TWO_SIDED|95.0|0.64|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||2.01|0.64|0.6542
73859063|NCT01103063|147263650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|19.71||0.9145|TWO_SIDED|95.0|-36.5|40.8||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable.|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||40.8|-36.5|0.9145
73859064|NCT01103063|147263651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.09|-0.04||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of symptomatic malaria).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.04|-0.09|<0.0001
73859065|NCT01103063|147263652|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|STANDARD_DEVIATION|0.1221|<|0.0001|TWO_SIDED|95.0|0.38|0.62||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.62|0.38|<0.0001
73859066|NCT01103063|147263653|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|STANDARD_DEVIATION|0.2295||0.036|TWO_SIDED|95.0|0.39|0.97||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.97|0.39|0.0360
73859067|NCT01103063|147263654|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|STANDARD_DEVIATION|0.163||0.1975|TWO_SIDED|95.0|0.59|1.12||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.12|0.59|0.1975
73859068|NCT01103063|147263655|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|STANDARD_DEVIATION|0.5675||0.4655|TWO_SIDED|95.0|0.22|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||2.01|0.22|0.4655
73859069|NCT01103063|147263656|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75|STANDARD_DEVIATION|0.0918||0.0016|TWO_SIDED|95.0|0.62|0.9||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.90|0.62|0.0016
73859070|NCT01103063|147263657|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.34|STANDARD_DEVIATION|0.5338||0.1113|TWO_SIDED|95.0|0.82|6.66||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||6.66|0.82|0.1113
73859071|NCT01103063|147263658|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.25|STANDARD_DEVIATION|0.6386||0.0284|TWO_SIDED|95.0|0.07|0.86||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.86|0.07|0.0284
74088378|NCT00441350|147730193|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74088379|NCT00441350|147730194|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
74088380|NCT00441350|147730195|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
74088381|NCT00441350|147730196|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
73859072|NCT01103063|147263659|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46|STANDARD_DEVIATION|0.3291||0.0188|TWO_SIDED|95.0|0.24|0.88||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.88|0.24|0.0188
74085710|NCT01844531|147725642|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.79|STANDARD_ERROR_OF_MEAN|6.7||0|TWO_SIDED|90.0|99.077|106.633||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500 , PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||106.633|99.077|0.0000
73859073|NCT01103063|147263660|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|STANDARD_DEVIATION|0.1336||0.0527|TWO_SIDED|95.0|0.59|1.0||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.00|0.59|0.0527
73859074|NCT01103063|147263661|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73|STANDARD_DEVIATION|0.1536||0.0384|TWO_SIDED|95.0|0.54|0.98||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.98|0.54|0.0384
73859075|NCT01103063|147263662|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.09|STANDARD_DEVIATION|0.8648||0.3942|TWO_SIDED|95.0|0.38|11.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||11.38|0.38|0.3942
73859076|NCT01103063|147263663|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.39|STANDARD_DEVIATION|0.4439||0.0332|TWO_SIDED|95.0|0.16|0.93||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.93|0.16|0.0332
73859077|NCT01103063|147263664|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.61|STANDARD_DEVIATION|0.4195||0.2321|TWO_SIDED|95.0|0.27|1.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.38|0.27|0.2321
73859078|NCT01103063|147263665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.76||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.||||1.0000
73859079|NCT01103063|147263665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.||||1.0000
73859080|NCT01103063|147263666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.||||1.0000
73859081|NCT01103063|147263666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.||||1.0000
73859082|NCT01437098|147263672|SUPERIORITY_OR_OTHER||Proportion of IF Implanted Subjects|91.7|||<|0.001|TWO_SIDED|95.0|77.5|98.2|||Exact binomial|||||98.2|77.5|<0.001
73859083|NCT02868034|147263736|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.025|TWO_SIDED|97.5|-0.26|0.22|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|SMT Component Main Effects at 4 weeks||0.22|-0.26|0.025
73859084|NCT02868034|147263736|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.025|TWO_SIDED|97.5|-0.43|0.09|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|SMT Component Main Effects after 12 weeks||0.09|-0.43|0.025
73859085|NCT02868034|147263736|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.025|TWO_SIDED|97.5|-0.11|0.38|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Mobilizing Exercise Treatment Component Main Effects at 4 weeks||0.38|-0.11|0.025
73859086|NCT02868034|147263736|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.025|TWO_SIDED|97.5|-0.23|0.29|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Mobilizing Exercise Component Main Effects at 12 weeks||0.29|-0.23|0.025
74085711|NCT01844531|147725642|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.5|STANDARD_ERROR_OF_MEAN|6.7|<|0.0001|TWO_SIDED|90.0|98.78|106.36|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 (T2) : Empa5 + Met500 (R2), PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.36|98.78|<.0001
73859087|NCT02868034|147263736|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.025|TWO_SIDED|97.5|-0.45|0.04|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Activating Exercise Component Main Effect at 4 weeks||0.04|-0.45|0.025
73965537|NCT05107401|147466598|SUPERIORITY||Mean Difference (Final Values)|-5.09||||0.012|TWO_SIDED|95.0|-8.59|-1.58||To account for multiple comparisons arising from analyses of moderating effects, the false discovery rate (FDR) was controlled using Benjamini-Hochberg procedures in a tiered approach.|Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference in females between study arms from baseline to the three-month follow-up.|Sex was marginally significant in the initial multilevel mixed models, therefore, we examined potential moderation effects of sex on stigma changes. Fixed effects corresponding to the two-way interactions involving sex, time, and/or arm, as well as the three-way interaction of sex, time, and arm, were added to the models.||-1.58|-8.59|0.012
74026984|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.41|0.30|
74026985|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.45|0.35|
74026986|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.51|0.36|
74026987|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.35|0.58|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.58|0.35|
74026988|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.62|0.39|
74026989|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.54|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.54|0.34|
74026990|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.23|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.42|0.23|
74026991|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.15|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.24|0.15|
74026992|NCT01025336|147607524|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.69|0.42|
74026993|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.50|0.36|
74026994|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.48|0.36|
74026995|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.33|0.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.44|0.33|
74026996|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.26|0.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.37|0.26|
74088382|NCT00255151|147730204|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
73859088|NCT02868034|147263736|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.025|TWO_SIDED|97.5|-0.45|0.07|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater change when the component was used|Activating Exercise Component Main Effect at 12 weeks||0.07|-0.45|0.025
73859089|NCT02868034|147263736|SUPERIORITY||interaction relative mean difference|-0.17||||0.025|TWO_SIDED|97.5|-0.66|0.32|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||0.32|-0.66|0.025
73965538|NCT05107401|147466598|SUPERIORITY||Mean Difference (Final Values)|1.58||||0.56|TWO_SIDED|95.0|-2.26|5.42||To account for multiple comparisons arising from analyses of moderating effects, the false discovery rate (FDR) was controlled using Benjamini-Hochberg procedures in a tiered approach.|Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference in males between study arms from baseline to the three-month follow-up.|Sex was marginally significant in the initial multilevel mixed models, therefore, we examined potential moderation effects of sex on stigma changes. Fixed effects corresponding to the two-way interactions involving sex, time, and/or arm, as well as the three-way interaction of sex, time, and arm, were added to the models.||5.42|-2.26|0.56
73965539|NCT05687903|147466677|SUPERIORITY||Estimate of LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|2.983|=|0.001|TWO_SIDED|95.0|7.74|19.57||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.|LS in LS Mean Difference denotes least squares.|||19.57|7.74|=0.001
73965540|NCT05687903|147466677|SUPERIORITY||Estimate of LS Mean Difference|24.67|STANDARD_ERROR_OF_MEAN|2.921|<|0.001|TWO_SIDED|95.0|18.87|30.46||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||30.46|18.87|<0.001
74026997|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.68|0.42|
73859090|NCT02868034|147263736|SUPERIORITY||interaction relative mean difference|-0.1||||0.025|TWO_SIDED|97.5|-0.62|0.42|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||0.42|-0.62|0.025
73859091|NCT02868034|147263736|SUPERIORITY||interaction relative mean difference|0.13||||0.025|TWO_SIDED|97.5|-0.36|0.62|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||0.62|-0.36|0.025
73859092|NCT02868034|147263736|SUPERIORITY||interaction relative mean difference|0.5||||0.025|TWO_SIDED|97.5|-0.02|1.02|||Mixed Models Analysis|||||1.02|-0.02|0.025
73859093|NCT02868034|147263736|SUPERIORITY||interaction relative mean difference|-0.17||||0.025|TWO_SIDED|97.5|-0.66|0.32|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||0.32|-0.66|0.025
73859094|NCT02868034|147263736|SUPERIORITY||interaction relative mean difference|0.39||||0.025|TWO_SIDED|97.5|-0.13|0.91|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||0.91|-0.13|0.025
73859095|NCT02868034|147263736|SUPERIORITY||3-way interaction relative mean dif.|0.25||||0.025|TWO_SIDED|97.5|-0.24|0.74|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||0.74|-0.24|0.025
73859096|NCT02868034|147263736|SUPERIORITY||3-way interaction relative mean dif.|0.4||||0.025|TWO_SIDED|97.5|-0.12|0.92|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||0.92|-0.12|0.025
73859097|NCT02868034|147263737|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.025|TWO_SIDED|97.5|-2.67|1.52|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.||SMT Component Main Effects at 4 weeks|A positive value indicates greater improvement in muscle activation when the component was used|1.52|-2.67|0.025
73859098|NCT02868034|147263737|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.025|TWO_SIDED|97.5|-2.76|2.02|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|SMT Component Main Effects at 12 weeks||2.02|-2.76|0.025
73859099|NCT02868034|147263737|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.025|TWO_SIDED|97.5|-2.03|2.16|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Mobilizing Component Main Effects at 4 weeks||2.16|-2.03|0.025
73859100|NCT02868034|147263737|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.025|TWO_SIDED|97.5|-1.68|3.11|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Mobilizing Component Main Effects at 12 weeks||3.11|-1.68|0.025
73859101|NCT02868034|147263737|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.025|TWO_SIDED|97.5|-2.94|1.25|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Activating Exercise Component at 4 weeks||1.25|-2.94|0.025
73859102|NCT02868034|147263737|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.025|TWO_SIDED|97.5|-2.97|1.82|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Activating Exercise Component at 12 weeks||1.82|-2.97|0.025
73859103|NCT02868034|147263737|SUPERIORITY||interaction relative mean difference|0.8||||0.025|TWO_SIDED|97.5|-3.39|4.99|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||4.99|-3.39|0.025
73859104|NCT02868034|147263737|SUPERIORITY||interaction relative mean difference|-0.68||||0.025|TWO_SIDED|97.5|-5.47|4.11|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||4.11|-5.47|0.025
73965541|NCT05687903|147466677|SUPERIORITY||Estimate of LS Mean Difference|26.58|STANDARD_ERROR_OF_MEAN|2.91|<|0.001|TWO_SIDED|95.0|20.81|32.35||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||32.35|20.81|<0.001
73965542|NCT05687903|147466677|SUPERIORITY||Estimate of LS Mean Difference|16.13|STANDARD_ERROR_OF_MEAN|2.842|<|0.001|TWO_SIDED|95.0|10.49|21.76||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||21.76|10.49|<0.001
74026998|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.64|1.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.14|0.64|
73859105|NCT02868034|147263737|SUPERIORITY||interaction relative mean difference|-1.56||||0.025|TWO_SIDED|97.5|-5.75|2.63|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||2.63|-5.75|0.025
73859106|NCT02868034|147263737|SUPERIORITY||interaction relative mean difference|1.42||||0.025|TWO_SIDED|97.5|-3.37|6.21|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||6.21|-3.37|0.025
73859107|NCT02868034|147263737|SUPERIORITY||interaction relative mean difference|-0.44||||0.025|TWO_SIDED|97.5|-4.63|3.75|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||3.75|-4.63|0.025
73859108|NCT02868034|147263737|SUPERIORITY||interaction relative mean difference|2.01||||0.025|TWO_SIDED|97.5|-2.77|6.8|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||6.80|-2.77|0.025
73859109|NCT02868034|147263737|SUPERIORITY||3-way interaction relative mean dif.|-0.18||||0.025|TWO_SIDED|97.5|-4.37|4.01|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||4.01|-4.37|0.025
73859110|NCT02868034|147263737|SUPERIORITY||3-way interaction relative mean dif.|0.56||||0.025|TWO_SIDED|97.5|-4.22|5.35|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||5.35|-4.22|0.025
73859111|NCT02868034|147263738|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.025|TWO_SIDED|97.5|-4.0|1.68|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|SMT Treatment Component Main Effect at 4-weeks||1.68|-4.0|0.025
73859112|NCT02868034|147263738|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.025|TWO_SIDED|97.5|-3.46|3.07|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|SMT Treatment Component Main Effect at 12-weeks||3.07|-3.46|0.025
73859113|NCT02868034|147263738|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.025|TWO_SIDED|97.5|-4.2|1.48|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Mobilizing Exercise Treatment Component main effect after 4-weeks||1.48|-4.2|0.025
73859114|NCT02868034|147263738|SUPERIORITY||Mean Difference (Final Values)|-1.72||||0.025|TWO_SIDED|97.5|-4.99|1.55|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Mobilizing Exercise Treatment Component main effect after 12-weeks||1.55|-4.99|0.025
73859115|NCT02868034|147263738|SUPERIORITY||Mean Difference (Final Values)|-2.34||||0.025|TWO_SIDED|97.5|-5.18|0.5|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Activating Exercise Treatment Component main effect after 4-weeks||0.50|-5.18|0.025
73859116|NCT02868034|147263738|SUPERIORITY||Mean Difference (Final Values)|-3.62||||0.025|TWO_SIDED|97.5|-6.89|-0.35|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Activating Treatment Component Main Effect after 12-weeks||-0.35|-6.89|0.025
73859117|NCT02868034|147263738|SUPERIORITY||interaction relative mean difference|3.24||||0.025|TWO_SIDED|97.5|-2.45|8.92|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||8.92|-2.45|0.025
73859118|NCT02868034|147263738|SUPERIORITY||interaction relative mean difference|4.34||||0.025|TWO_SIDED|97.5|-2.19|10.87|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||10.87|-2.19|0.025
73859119|NCT02868034|147263738|SUPERIORITY||interaction relative mean difference|0.57||||0.025|TWO_SIDED|97.5|-5.12|6.25|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||6.25|-5.12|0.025
73859120|NCT02868034|147263738|SUPERIORITY||interaction relative mean difference|-0.67||||0.025|TWO_SIDED|97.5|-7.2|5.87|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||5.87|-7.20|0.025
73859121|NCT02868034|147263738|SUPERIORITY||interaction relative mean difference|4.64||||0.025|TWO_SIDED|97.5|-1.04|10.32|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||10.32|-1.04|0.025
73859122|NCT02868034|147263738|SUPERIORITY||interaction relative mean difference|1.49||||0.025|TWO_SIDED|97.5|-5.04|8.02|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||8.02|-5.04|0.025
73859123|NCT02868034|147263738|SUPERIORITY||3-way interaction relative mean dif.|-0.86||||0.025|TWO_SIDED|97.5|-6.54|4.82|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||4.82|-6.54|0.025
73859124|NCT02868034|147263738|SUPERIORITY||3-way interaction relative mean dif.|0.04||||0.025|TWO_SIDED|97.5|-6.5|6.57|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||6.57|-6.50|0.025
74088383|NCT00255151|147730204|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
74026999|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.82|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.82|0.60|
73859125|NCT02868034|147263739|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.025|TWO_SIDED|97.5|-0.6|0.32|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|SMT Treatment Component Main Effect at 4-weeks||0.32|-0.60|0.025
73859126|NCT02868034|147263739|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.025|TWO_SIDED|97.5|-0.44|0.61|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|SMT Treatment Component Main Effects at 12 weeks||0.61|-0.44|0.025
73859127|NCT02868034|147263739|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.025|TWO_SIDED|97.5|-0.92|0.0|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Mobilizing Exercise Component Main Effects at 4 weeks||0.0|-0.92|0.025
73859128|NCT02868034|147263739|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.025|TWO_SIDED|97.5|-0.7|0.34|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Mobilizing Exercise Component Main Effects at 12 weeks||0.34|-0.70|0.025
73859129|NCT02868034|147263739|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.025|TWO_SIDED|97.5|-0.62|0.3|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Activating Exercise Component Main Effects at 4 weeks||0.30|-0.62|0.025
73859130|NCT02868034|147263739|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.025|TWO_SIDED|97.5|-0.71|0.33|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Activating Exercise Component Main Effects at 12 weeks||0.33|-0.71|0.025
73859131|NCT02868034|147263739|SUPERIORITY||interaction relative mean difference|0.38||||0.025|TWO_SIDED|97.5|-0.54|1.3|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||1.30|-0.54|0.025
73859132|NCT02868034|147263739|SUPERIORITY||interaction relative mean difference|0.45||||0.025|TWO_SIDED|97.5|-0.6|1.49|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||1.49|-0.60|0.025
73859133|NCT02868034|147263739|SUPERIORITY||interaction relative mean difference|0.12||||0.025|TWO_SIDED|97.5|-0.8|1.04|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||1.04|-0.80|0.025
73859134|NCT02868034|147263739|SUPERIORITY||interaction relative mean difference|0.23||||0.025|TWO_SIDED|97.5|-0.81|1.28|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||1.28|-0.81|0.025
73859135|NCT02868034|147263739|SUPERIORITY||interaction relative mean difference|0.89||||0.025|TWO_SIDED|97.5|-0.03|1.81|||Mixed Models Analysis|||||1.81|-0.03|0.025
73859136|NCT02868034|147263739|SUPERIORITY||interaction relative mean difference|-0.02||||0.025|TWO_SIDED|97.5|-1.07|1.02|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||1.02|-1.07|0.025
74088384|NCT00255151|147730204|SUPERIORITY_OR_OTHER|||||||0.80473||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.80473
73859137|NCT02868034|147263739|SUPERIORITY||3-way interaction relative mean dif.|0.71||||0.025|TWO_SIDED|97.5|-0.21|1.63|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||1.63|-0.21|0.025
73859138|NCT02868034|147263739|SUPERIORITY||3-way interaction relative mean dif.|0.0||||0.025|TWO_SIDED|97.5|-1.05|1.04|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||1.04|-1.05|0.025
73859139|NCT01509677|147263742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7922||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided test at 5% significant level||||0.7922
73859140|NCT01509677|147263742|SUPERIORITY||Risk Ratio (RR)|1.03|STANDARD_ERROR_OF_MEAN|0.12||0.7917|TWO_SIDED|95.0|0.82|1.3|||Poisson regression model|||||1.30|0.82|0.7917
73859141|NCT01509677|147263743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7145||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided, 5% test||||0.7145
73859142|NCT01509677|147263744|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.04|STANDARD_ERROR_OF_MEAN|0.119||0.7136|TWO_SIDED|95.0|0.83|1.3|||Poisson regression model|||2-sided 5% test||1.30|0.83|0.7136
73859143|NCT01509677|147263745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.4|STANDARD_ERROR_OF_MEAN|15.45||0.4606||95.0|-19.2|42.1|||ANCOVA|||2-sided 5% test||42.1|-19.2|0.4606
73859144|NCT01509677|147263746|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19|STANDARD_ERROR_OF_MEAN|0.194||0.2744|TWO_SIDED|95.0|0.87|1.64|||Poisson regression model|||2-sided 5% test||1.64|0.87|0.2744
73859145|NCT01509677|147263747|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.85|STANDARD_ERROR_OF_MEAN|0.086||0.1128|TWO_SIDED|95.0|0.7|1.04|||Poisson regression model|||2-sided 5% test||1.04|0.70|0.1128
73859146|NCT01509677|147263748|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|STANDARD_ERROR_OF_MEAN|0.164||0.674|TWO_SIDED|95.0|0.66|1.31|||Regression, Linear|Poisson regression model||2-sided 5% test||1.31|0.66|0.6740
73859147|NCT01509677|147263749|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.84|STANDARD_ERROR_OF_MEAN|0.082||0.0677|TWO_SIDED|95.0|0.69|1.01|||Poisson regression model|||2-sided 5% test||1.01|0.69|0.0677
73859148|NCT01509677|147263750|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.82|STANDARD_ERROR_OF_MEAN|0.177||0.3566|TWO_SIDED|95.0|0.54|1.25|||Poisson regression model|||2-sided 5% test||1.25|0.54|0.3566
73965543|NCT05687903|147466678|SUPERIORITY||Estimate of LS Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|1.564|=|0.004|TWO_SIDED|95.0|-9.53|-3.32||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-3.32|-9.53|=0.004
73965544|NCT05687903|147466678|SUPERIORITY||Estimate of LS Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|1.581|<|0.001|TWO_SIDED|95.0|-14.44|-8.16||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-8.16|-14.44|<0.001
73965545|NCT05687903|147466678|SUPERIORITY||Estimate of LS Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|1.53|<|0.001|TWO_SIDED|95.0|-13.35|-7.27||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-7.27|-13.35|<0.001
73965546|NCT05687903|147466678|SUPERIORITY||Estimate of LS Mean Difference|-8.79|STANDARD_ERROR_OF_MEAN|1.535|<|0.001|TWO_SIDED|95.0|-11.84|-5.75||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-5.75|-11.84|<0.001
73859149|NCT01509677|147263751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6354|STANDARD_ERROR_OF_MEAN|2.30185||0.4794|TWO_SIDED|95.0|-2.9429|6.2137|||ANCOVA|||2 sided 5% test||6.2137|-2.9429|0.4794
73859150|NCT01509677|147263752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4727|STANDARD_ERROR_OF_MEAN|0.32866||0.1541|TWO_SIDED|95.0|-0.181|1.1264|||ANCOVA|||2 sided 5% test||1.1264|-0.1810|0.1541
73859151|NCT01509677|147263753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0626|STANDARD_ERROR_OF_MEAN|0.03681||0.0927|TWO_SIDED|95.0|-0.1358|0.0106|||ANCOVA|||2 sided 5% test||0.0106|-0.1358|0.0927
73859152|NCT01509677|147263754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0107|STANDARD_ERROR_OF_MEAN|0.01647||0.5175|TWO_SIDED|95.0|-0.0435|0.022|||ANCOVA|||2 sided 5% test||0.0220|-0.0435|0.5175
73859153|NCT01509677|147263755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.146|STANDARD_ERROR_OF_MEAN|3.3253||0.5205|TWO_SIDED|95.0|-4.466|8.757|||ANCOVA|||2-sided 5 % test||8.757|-4.466|0.5205
73859154|NCT01509677|147263756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.141|STANDARD_ERROR_OF_MEAN|3.0057||0.7052|TWO_SIDED|95.0|-4.835|7.117|||ANCOVA|||2-sided 5 % test||7.117|-4.835|0.7052
73859155|NCT01509677|147263757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.867|STANDARD_ERROR_OF_MEAN|0.7331||0.0127|TWO_SIDED|95.0|-3.324|-0.409|||ANCOVA|||2-sided 5 % test||-0.409|-3.324|0.0127
73859156|NCT01509677|147263758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.1871||0.7862|TWO_SIDED|95.0|-0.423|0.321|||ANCOVA|||2-sided 5 % test||0.321|-0.423|0.7862
73859157|NCT01509677|147263759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.005||0.8769|TWO_SIDED|95.0|-1.84|2.15|||ANCOVA|||2-sided 5% test||2.15|-1.84|0.8769
73859158|NCT01509677|147263760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|711.1|STANDARD_ERROR_OF_MEAN|2768.79||0.7978|TWO_SIDED|95.0|-4778.3|6200.5|||ANCOVA|||2-sided 5% test||6200.5|-4778.3|0.7978
73859159|NCT01509677|147263761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|88.5|STANDARD_ERROR_OF_MEAN|79.26||0.2669|TWO_SIDED|95.0|-68.6|245.6|||ANCOVA|||2-sided 5% test||245.6|-68.6|0.2669
73859160|NCT01509677|147263762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.9|STANDARD_ERROR_OF_MEAN|67.78||0.7033|TWO_SIDED|95.0|-160.3|108.5|||ANCOVA|||2-sided 5% test||108.5|-160.3|0.7033
73859161|NCT01509677|147263763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.79|STANDARD_ERROR_OF_MEAN|18.039||0.1264|TWO_SIDED|95.0|-7.97|63.55|||ANCOVA|||2-sided 5% test||63.55|-7.97|0.1264
73859162|NCT01509677|147263764|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|296.8|STANDARD_ERROR_OF_MEAN|124.07||0.0185|TWO_SIDED|95.0|50.9|542.7|||ANCOVA|||2-sided 5% test||542.7|50.9|0.0185
73859163|NCT01509677|147263765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.086||0.9989|TWO_SIDED|95.0|-0.17|0.17|||ANCOVA|||2-sided 5% test||0.17|-0.17|0.9989
73859164|NCT01509677|147263766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.309||0.6701|TWO_SIDED|95.0|-3.15|2.03|||ANCOVA|||2-sided 5% test||2.03|-3.15|0.6701
73859165|NCT01509677|147263767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.1||0.1105|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA|||2-sided 5% test||3.9|-0.4|0.1105
73859166|NCT01509677|147263768|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|15.62||0.9261|TWO_SIDED|95.0|-32.4|29.5|||ANCOVA|||2-sided 5% test||29.5|-32.4|0.9261
73859167|NCT01509677|147263769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|4.49||0.0257|TWO_SIDED|95.0|1.2|19.0|||ANCOVA|||2-sided 5% test||19.0|1.2|0.0257
73859168|NCT01509677|147263770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.8|STANDARD_ERROR_OF_MEAN|18.11||0.0728|TWO_SIDED|95.0|-3.0|168.6|||ANCOVA|||2-sided 5% test||168.6|-3.0|0.0728
73859169|NCT01509677|147263771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.03||0.038|TWO_SIDED|95.0|0.004|0.122|||ANCOVA|||2-sided 5% test||0.122|0.004|0.0380
73859170|NCT01509677|147263772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.0552||0.2482|TWO_SIDED|95.0|-0.045|0.173|||ANCOVA|||2-sided 5% test||0.173|-0.045|0.2482
73859171|NCT01509677|147263773|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-1.0||||0.2629|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|Between treatment difference||2 sided 5 % test||1.00|-2.00|0.2629
73859172|NCT03640052|147263774|SUPERIORITY||Mean Difference (Final Values)|3.6|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
73859173|NCT03640052|147263774|SUPERIORITY||Mean Difference (Net)|-2.0|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
73859174|NCT03640052|147263774|SUPERIORITY||Mean Difference (Net)|-6.8|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
73859175|NCT03640052|147263774|SUPERIORITY||Mean Difference (Net)|-11.7||||0.33|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||0.33
73859176|NCT03640052|147263775|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
73859177|NCT03549871|147263816|SUPERIORITY||ABR ratio|0.389|||=|0.0008|TWO_SIDED|95.0|0.224|0.675||The threshold for significance was \<0.05.|Repeated measures NB regression model|||Analyzed using repeated measures NB model with fixed effect of treatment period (fitusiran efficacy period or factor/BPA prophylaxis period) and robust sandwich covariance matrix was constructed to account for within participant dependence, logarithm of duration (in years) that each participant spends in each study period matching BE data being analyzed as an offset variable.||0.675|0.224|=0.0008
73859178|NCT03549871|147263818|SUPERIORITY||ABR ratio|0.444|||||TWO_SIDED|95.0|0.234|0.842||||||||0.842|0.234|
73859179|NCT03549871|147263820|SUPERIORITY||ABR ratio|0.485|||||TWO_SIDED|95.0|0.259|0.91||||||||0.910|0.259|
73859180|NCT01133626|147263833|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower limit of a two-sided 95% CI for the geometric mean ratio of BDP HFA 320 mcg/day to placebo was greater than 0.80.|geometric mean ratio|0.96|||||TWO_SIDED|95.0|0.87|1.06|||ANCOVA|||||1.06|0.87|
73859181|NCT00294645|147263843|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Modified Peto-Peto|A one-sided test was used.||Null hypothesis: control rate = remote rate||||<0.0001
73859182|NCT04600505|147263880|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|111.7|||||TWO_SIDED|90.0|91.01|137.1||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||137.1|91.01|
73859183|NCT04600505|147263880|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.78|||||TWO_SIDED|90.0|78.67|124.0||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||124.0|78.67|
73859184|NCT04600505|147263880|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|108.3|||||TWO_SIDED|90.0|85.5|137.3||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)||137.3|85.50|
73859185|NCT04600505|147263880|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|94.88|||||TWO_SIDED|90.0|74.69|120.5||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)||120.5|74.69|
73859186|NCT04600505|147263880|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|109.1|||||TWO_SIDED|90.0|97.02|122.7||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||122.7|97.02|
73859187|NCT04600505|147263880|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|100.1||||||90.0|83.78|119.5||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||119.5|83.78|
73859188|NCT04600505|147263881|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|104.7|||||TWO_SIDED|90.0|91.95|119.2||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||119.2|91.95|
73859189|NCT04600505|147263881|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.03|||||TWO_SIDED|90.0|83.33|115.3||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||115.3|83.33|
73859190|NCT04600505|147263881|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|96.0||||||90.0|70.33|131.0||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||131.0|70.33|
73859191|NCT04600505|147263881|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|116.7||||||90.0|86.31|157.8||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||157.8|86.31|
73859192|NCT04600505|147263882|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|107.3|||||TWO_SIDED|90.0|94.53|121.9||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||121.9|94.53|
73859193|NCT04600505|147263882|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.8|||||TWO_SIDED|90.0|84.59|115.4||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||115.4|84.59|
73859194|NCT04600505|147263882|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|106.1|||||TWO_SIDED|90.0|86.18|130.6||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)||130.6|86.18|
73859195|NCT04600505|147263882|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|99.71|||||TWO_SIDED|90.0|80.84|123.0||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)||123.0|80.84|
73859196|NCT04600505|147263882|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.13|||||TWO_SIDED|90.0|86.44|111.4||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||111.4|86.44|
73859197|NCT04600505|147263882|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|107.0|||||TWO_SIDED|90.0|88.82|128.9||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||128.9|88.82|
73859198|NCT04065074|147263930|OTHER|Proportion of Successful Administrations|Proportion of Successful Administrations|0.75|||||TWO_SIDED|90.0|0.51|0.9||||||||0.90|0.51|
73913869|NCT03385564|147357367|OTHER||Difference|-2.86||||0.9275|TWO_SIDED|80.0|-28.58|21.1|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||21.10|-28.58|0.9275
73913870|NCT03385564|147357367|OTHER||Difference|-10.0||||0.6064|TWO_SIDED|80.0|-29.9|10.64|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||10.64|-29.90|0.6064
73913871|NCT03385564|147357367|OTHER||Difference|0.0|||||TWO_SIDED|80.0|-18.37|18.07|||||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||18.07|-18.37|
73913872|NCT03385564|147357368|OTHER||Difference|3.73||||0.9119|TWO_SIDED|80.0|-20.53|29.6|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||29.60|-20.53|0.9119
73913873|NCT03385564|147357368|OTHER||Difference|3.73||||0.851|TWO_SIDED|80.0|-16.58|24.31|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||24.31|-16.58|0.8510
73913874|NCT03385564|147357368|OTHER||Difference|16.43||||0.3498|TWO_SIDED|80.0|-3.53|34.73|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||34.73|-3.53|0.3498
73913875|NCT03385564|147357369|OTHER||Difference|5.43||||0.7921|TWO_SIDED|80.0|-10.19|23.57|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||23.57|-10.19|0.7921
73913876|NCT03385564|147357371|OTHER||Difference|32.0||||0.1016|TWO_SIDED|80.0|10.28|44.74|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||44.74|10.28|0.1016
73913877|NCT03385564|147357371|OTHER||Difference|-3.71||||0.8323|TWO_SIDED|80.0|-23.79|15.29|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||15.29|-23.79|0.8323
73913878|NCT03385564|147357371|OTHER||Difference|7.0||||0.6247|TWO_SIDED|80.0|-10.5|23.31|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||23.31|-10.50|0.6247
73913879|NCT01146834|147357376|SUPERIORITY||Risk Difference (RD)|-0.02||||0.9|TWO_SIDED|95.0|-0.32|0.28|||Chi-squared|||Arm B was initially closed due to low accrual, and Arms D and E were also closed due to no accrual. Arms A and C also had very low accrual. Therefore, the comparison of the primary outcome between Arms A and C is for exploratory purposes only.||0.28|-0.32|0.90
73913880|NCT01146834|147357378|SUPERIORITY||Risk Difference (RD)|-0.25||||0.25|TWO_SIDED|95.0|-0.68|0.18|||Fisher Exact|||||0.18|-0.68|0.25
73913881|NCT00113022|147357380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|18.867||0.919|TWO_SIDED|95.0|-46.565|51.006||The test reported here examines the main effect for placebo versus drug.|Mixed Models Analysis||A positive value indicates greater depression in the active treatment group compared to placebo.|Per protocol, a linear mixed model with a first order autoregressive covariance structure was used. Baseline was included as a covariate. Drug and visit were main effects with an interaction between them included.||51.006|-46.565|.919
73913882|NCT00457301|147357382|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.1||0.05||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.||||0.05
73913883|NCT00457301|147357383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34||95.0|||||ANCOVA|||ANCOVA adjuusting for baseline HADS anxiety scores||||0.34
73913884|NCT00457301|147357383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANCOVA|||ANCOVA adjusting for baseline HADS depression scores.||||0.55
73913885|NCT00457301|147357384|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.79|STANDARD_ERROR_OF_MEAN|0.23||0.001||95.0|||||ANCOVA|||||||0.001
73913886|NCT00457301|147357385|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.46||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.||||0.46
73913887|NCT01552694|147357408|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted p-value compares the change (week 8 - baseline) for plasma hsCRP between the 2 groups.|t-test, 2 sided|||||||0.006
73913888|NCT01552694|147357409|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted analysis.|t-test, 2 sided|||||||0.24
73913889|NCT01552694|147357410|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted analysis|t-test, 2 sided|||||||0.78
74088385|NCT00255151|147730205|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
73913890|NCT00147446|147357472|SUPERIORITY_OR_OTHER||Wilcoxon two smaple test statistics|2.09||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that treatment with stress management produced a significant reduction in cumulative Gd+ lesions compared to the control condition during the treatment period||||0.04
73913891|NCT00147446|147357472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.02|TWO_SIDED|95.0|1.17|6.55|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving stress management remained free of Gd+ lesions during the treatment, compared to those receiving the control condition.||6.55|1.17|0.02
73913892|NCT00147446|147357473|SUPERIORITY_OR_OTHER||Wilcoxon two sample test statistics|2.84||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that participants receiving SMT-MS showed a significant reduction in cumulative new T2 lesions, compared to those receiving the control condition during the treatment period.||||0.005
73913893|NCT00147446|147357473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.07||||0.006|TWO_SIDED|95.0|1.38|6.81|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving SMT-MS remained free of new T2 lesions during the treatment, compared to control condition participants.||6.81|1.38|0.006
73913894|NCT03329573|147357474|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.059|||||TWO_SIDED|90.0|1.006|1.115||||||||1.115|1.006|
73913895|NCT03329573|147357475|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||TWO_SIDED|90.0|0.947|1.047||||||||1.047|0.947|
73913896|NCT03329573|147357476|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.064|||||TWO_SIDED|90.0|1.01|1.12||||||||1.120|1.010|
73859199|NCT00871117|147263937|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% confidence interval (CI) for the between-group differences in booster response to diphtheria was greater than or equal to (≥)-10%.|Difference in booster response rates|0.01|||||TWO_SIDED|95.0|-2.54|2.58||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of diphtheria (D) booster response one month after vaccination with DTaP-IPV vaccine.||2.58|-2.54|
73859200|NCT00871117|147263937|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to tetanus was ≥ -10%.|Difference in booster response rates|0.98|||||TWO_SIDED|95.0|-1.99|4.26||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of tetanus (T) booster response one month after vaccination with DTaP-IPV vaccine.||4.26|-1.99|
73859201|NCT00871117|147263938|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PT was ≥ -10%|Difference in booster response rates|-0.76|||||TWO_SIDED|95.0|-5.07|3.51||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertussis toxoid (PT) booster response one month after vaccination with DTaP-IPV vaccine.||3.51|-5.07|
73859202|NCT00871117|147263938|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to FHA was ≥ -10%.|Difference in booster response rates|-0.91|||||TWO_SIDED|95.0|-3.59|1.39||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of filamentous hemagglutinin (FHA) booster response one month after vaccination with DTaP-IPV vaccine.||1.39|-3.59|
73859203|NCT00871117|147263938|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PRN, was ≥ -10%.|Difference in booster response rates|1.42|||||TWO_SIDED|95.0|-0.32|4.08||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertactin (PRN) booster response one month after vaccination with DTaP-IPV vaccine.||4.08|-0.32|
73859204|NCT00871117|147263939|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios for poliovirus type 1 antigens was ≥ 0.67.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.76|1.1||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 1 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||1.1|0.76|
73859205|NCT00871117|147263939|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios of poliovirus type 2 antigens was ≥ 0.67.|Adjusted GMT ratio|0.83|||||TWO_SIDED|95.0|0.7|0.99||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 2 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||0.99|0.7|
73859206|NCT00871117|147263939|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios of poliovirus type 3 antigens was ≥ 0.67.|Adjusted GMT ratio|0.84|||||TWO_SIDED|95.0|0.71|1.01||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 3 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||1.01|0.71|
73859207|NCT02275117|147263956|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|12.6||||0.033|TWO_SIDED|95.0|1.3|24.0|||Cochran-Mantel-Haenszel|||||24.0|1.3|0.0330
73859208|NCT02275117|147263956|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|10.7||||0.0715|TWO_SIDED|95.0|-0.5|21.8|||Cochran-Mantel-Haenszel|||||21.8|-0.5|0.0715
73859209|NCT02275117|147263956|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|7.5||||0.2013|TWO_SIDED|95.0|-3.5|18.5|||Cochran-Mantel-Haenszel|||||18.5|-3.5|0.2013
73859210|NCT02275117|147263956|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|6.1||||0.2938|TWO_SIDED|95.0|-4.6|16.9|||Cochran-Mantel-Haenszel|||||16.9|-4.6|0.2938
73913897|NCT03329573|147357477|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||TWO_SIDED|90.0|0.949|1.044||||||||1.044|0.949|
74088386|NCT00255151|147730205|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
73859211|NCT00386477|147263976|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55||||0.11||95.0|0.26|1.11|||Chi-squared, Corrected|||||1.11|0.26|0.11
73859212|NCT00977938|147263978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.001|TWO_SIDED|95.0|0.59|0.85||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.||0.85|0.59|<0.001
73913898|NCT03329573|147357478|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.024|||||TWO_SIDED|90.0|0.952|1.101||||||||1.101|0.952|
73913899|NCT03329573|147357479|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.02|||||TWO_SIDED|90.0|0.968|1.074||||||||1.074|0.968|
73913900|NCT00650260|147357504|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Fisher Exact|||||||0.027
73859213|NCT00977938|147263979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.17|0.48||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.||0.48|0.17|<0.001
73859214|NCT00977938|147263980|NON_INFERIORITY_OR_EQUIVALENCE|The primary safety analysis was a noninferiority analysis performed with the use of the Farrington-Manning risk-difference approach. Assuming an annualized rate for moderate or severe bleeding of 1.9% and an absolute noninferiority margin of 0.8%, at a one-sided alpha level of significance of 0.025, we calculated that a sample size of 9960 patients would give the study 80% power to detect noninferiority.|Risk Difference (RD)|0.96||||0.704|TWO_SIDED|95.0|0.38|1.53||One-sided P-value for non-inferiority|Farrington-Manning||30-month DAPT vs. 12-month DAPT|||1.53|0.38|0.704
73859215|NCT00977938|147263981|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.28% (0.0228)|Risk Difference (RD)|-1.82|||<|0.001|ONE_SIDED|97.5||0.03||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 97.5% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have MACCE rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.||0.03||<0.001
73859216|NCT00977938|147263982|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.97% (0.0097)|Risk Difference (RD)|-1.05|||<|0.001|ONE_SIDED|97.5||-0.27||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 95% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have stent thrombosis rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.||-0.27||<0.001
73859217|NCT00977938|147263983|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.7|0.97|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||0.97|0.70|
73859218|NCT00977938|147263984|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.29|0.69|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||0.69|0.29|
73965547|NCT05687903|147466679|SUPERIORITY||IRR|0.48|||=|0.25|TWO_SIDED|95.0|0.25|0.93||GEE model featuring a negative binomial distribution was used for analysis where incidence rate was exponentiated LS mean \& incidence rate ratio (IRR) was exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.93|0.25|=0.250
73859219|NCT00977938|147263985|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.86|||||TWO_SIDED|95.0|0.24|1.48|||||30-month DAPT vs. 12-month DAPT|||1.48|0.24|
73859220|NCT00977938|147263986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.722|TWO_SIDED|95.0|0.57|1.47||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.||1.47|0.57|0.722
73859221|NCT00977938|147263987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.478|TWO_SIDED|95.0|0.15|1.64||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.||1.64|0.15|0.478
73859222|NCT00977938|147263988|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.12||||0.706|TWO_SIDED|95.0|-0.06|2.31|||Farrington-Manning|No formal hypothesis testing was done.|30-month DAPT vs. 12-month DAPT|||2.31|-0.06|0.706
73859223|NCT00977938|147263989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.58|1.4|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||1.40|0.58|
73859224|NCT00977938|147263990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.15|1.64|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|||1.64|0.15|
73859225|NCT00977938|147263991|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.03|||||TWO_SIDED|95.0|-0.21|2.28|||||30-month DAPT vs. 12-month DAPT|||2.28|-0.21|
73859226|NCT00884039|147264114|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher Exact|||||||0.57
73859227|NCT02648022|147264115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.91||||0.07|TWO_SIDED|95.0|0.92|9.27|||Regression, Linear|Multivariable Regression Analysis||||9.27|0.92|0.07
73859228|NCT02880514|147264164|SUPERIORITY|||||||0.0391||||||P-value not adjusted for multiplicity.|McNemar|McNemar's exact binomial test was employed to obtain the two-sided p-value at alpha level of 0.05.||||||0.0391
73859229|NCT02880514|147264165|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
74088387|NCT00255151|147730205|SUPERIORITY_OR_OTHER|||||||0.76046||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.76046
73913901|NCT00650260|147357505|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||t-test, 1 sided|||||||0.078
73913902|NCT00650260|147357508|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
73965548|NCT05687903|147466679|SUPERIORITY||IRR|0.36|||=|0.034|TWO_SIDED|95.0|0.16|0.79||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.79|0.16|=0.034
74027000|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.86|1.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.18|0.86|
73913903|NCT03307967|147357552|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Rank Sum||||||.07
73913904|NCT03307967|147357553|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Rank Sum Test||||||.98
73913905|NCT02761252|147357598|SUPERIORITY||Mean Difference (Final Values)|-0.194|STANDARD_ERROR_OF_MEAN|0.3429||0.5721|TWO_SIDED|95.0|-0.8693|0.4813|||ANCOVA|||||0.4813|-0.8693|0.5721
73913906|NCT02761252|147357599|SUPERIORITY||Mean Difference (Final Values)|-1.1552|STANDARD_ERROR_OF_MEAN|0.4489||0.0105|TWO_SIDED|95.0|-2.0379|-0.2725|||ANCOVA|||||-0.2725|-2.0379|0.0105
73913907|NCT02761252|147357600|SUPERIORITY||Mean Difference (Final Values)|-0.1393|STANDARD_ERROR_OF_MEAN|0.2009||0.4885|TWO_SIDED|95.0|-0.5342|0.2557|||ANCOVA|||||0.2557|-0.5342|0.4885
73913908|NCT02761252|147357601|SUPERIORITY||Mean Difference (Final Values)|-0.03615|STANDARD_ERROR_OF_MEAN|0.1504||0.81032|TWO_SIDED|95.0|-0.3319|0.2596|||ANCOVA|||||0.2596|-0.3319|0.81032
73913909|NCT02761252|147357602|OTHER||Mean Difference (Final Values)|0.8359|STANDARD_ERROR_OF_MEAN|0.9322||0.3704|TWO_SIDED|95.0|-0.9969|2.6688|||ANOVA|||||2.6688|-0.9969|0.3704
73913910|NCT02761252|147357603|SUPERIORITY||Median Difference (Final Values)|-0.837|STANDARD_ERROR_OF_MEAN|2.5735||0.7452|TWO_SIDED|95.0|-5.8968|4.2228|||ANOVA|||||4.2228|-5.8968|0.7452
73913911|NCT02513394|147357637|OTHER||Hazard Ratio (HR)|0.96||||0.65|TWO_SIDED|95.0|0.81|1.14|||Log Rank||This two sided p value was stratified by (neo)adjuvant chemotherapy (yes vs no) and age (\<=50 vs \>50).|||1.14|0.81|0.65
73913912|NCT02513394|147357638|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.82|1.19||||||||1.19|0.82|
73913913|NCT02513394|147357639|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.87|1.28||||||||1.28|0.87|
73913914|NCT02513394|147357640|OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.98|1.78||||||||1.78|0.98|
73913915|NCT02513394|147357641|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.57|1.23||||||||1.23|0.57|
73913916|NCT00042289|147357655|SUPERIORITY||Geometric mean ratio|0.62||||0.055|TWO_SIDED|90.0|0.44|0.88||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.44|0.055
73913917|NCT00042289|147357655|SUPERIORITY||Geometric mean ratio|0.64|||<|0.001|TWO_SIDED|90.0|0.55|0.73||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.73|0.55|<0.001
73913918|NCT00042289|147357655|SUPERIORITY||Geometric mean ratio|0.68||||0.22|TWO_SIDED|90.0|0.44|1.04||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.04|0.44|0.22
73913919|NCT00042289|147357655|SUPERIORITY||Geometric mean ratio|0.6|||<|0.001|TWO_SIDED|90.0|0.49|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.72|0.49|<0.001
73913920|NCT00042289|147357655|SUPERIORITY||Geometric mean ratio|0.76|||<|0.05|TWO_SIDED|90.0|0.64|0.89||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.64|<0.05
73913921|NCT00042289|147357655|SUPERIORITY||Geometric mean ratio|0.71|||<|0.05|TWO_SIDED|90.0|0.57|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.57|<0.05
73913922|NCT00042289|147357655|SUPERIORITY||Geometric mean ratio|0.98||||0.78|TWO_SIDED|90.0|0.71|1.35||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.35|0.71|0.78
73913923|NCT00042289|147357656|SUPERIORITY||Geometric mean ratio|0.51|||<|0.05|TWO_SIDED|90.0|0.42|0.63||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.63|0.42|<0.05
73913924|NCT00042289|147357656|SUPERIORITY||Geometric mean ratio|0.73|||<|0.05|TWO_SIDED|90.0|0.63|0.84||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.84|0.63|<0.05
73913925|NCT00042289|147357656|SUPERIORITY||Geometric mean ratio|0.58||||0.03|TWO_SIDED|90.0|0.34|0.98||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.98|0.34|0.03
74027001|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
73913926|NCT00042289|147357656|SUPERIORITY||Geometric mean ratio|0.67||||0.001|TWO_SIDED|90.0|0.51|0.89||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.51|0.001
73913927|NCT00042289|147357656|SUPERIORITY||Geometric mean ratio|1.34||||0.0684|TWO_SIDED|||||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||||0.0684
73913928|NCT00042289|147357656|SUPERIORITY||Geometric mean ratio|0.58|||<|0.05|TWO_SIDED|90.0|0.49|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.49|<0.05
73913929|NCT00042289|147357656|SUPERIORITY||Geometric mean ratio|0.6|||<|0.05|TWO_SIDED|90.0|0.53|0.68||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.53|<0.05
73913930|NCT00042289|147357657|SUPERIORITY||Geometric mean ratio|0.72||||0.008|TWO_SIDED|90.0|0.6|0.88||3rd Trimester vs. Postpartum|t-test, 2 sided|Paired sample t-test on natural log-transformed PK parameter||||0.88|0.60|0.008
73913931|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.63||||0.002|TWO_SIDED|90.0|0.52|0.75||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.75|0.52|0.002
73913932|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.71||||0.0003|TWO_SIDED|90.0|0.63|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.81|0.63|0.0003
73913933|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.57||||0.09|TWO_SIDED|90.0|0.34|0.98||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.98|0.34|0.09
74088388|NCT00255151|147730207|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
73913934|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.67||||0.004|TWO_SIDED|90.0|0.54|0.82||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.82|0.54|0.004
73913935|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.79||||0.27|TWO_SIDED|90.0|0.5|1.27||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.27|0.50|0.27
73913936|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.86||||0.7|TWO_SIDED|90.0|0.66|1.12||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.12|0.66|0.70
73913937|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.62||||0.46|TWO_SIDED|90.0|0.29|1.34||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.34|0.29|0.46
73913938|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.94||||0.5|TWO_SIDED|90.0|0.63|1.39||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.39|0.63|0.50
73913939|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.76|||<|0.1|TWO_SIDED|90.0|0.57|1.0||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.0|0.57|<0.10
73913940|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.56|||<|0.1|TWO_SIDED|90.0|0.42|0.73||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.73|0.42|<0.10
73913941|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.47|||<|0.1|TWO_SIDED|90.0|0.33|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.33|<0.10
73913942|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.44|||<|0.1|TWO_SIDED|90.0|0.36|0.54||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.54|0.36|<0.10
73913943|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.74||||0.1875|TWO_SIDED|90.0|0.53|1.04||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.04|0.53|0.1875
73913944|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.46||||0.1563|TWO_SIDED|90.0|0.19|1.11||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.11|0.19|0.1563
73913945|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.94||||0.241|TWO_SIDED|90.0|0.85|1.03||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.03|0.85|0.241
73913946|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|1.09||||0.837|TWO_SIDED|90.0|0.9|1.32||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.32|0.90|0.837
73913947|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.7|||<|0.05|TWO_SIDED|90.0|0.55|0.88||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.88|0.55|<0.05
73913948|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.8||||0.0046|TWO_SIDED|90.0|0.72|0.89||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.89|0.72|0.0046
73913949|NCT00042289|147357658|SUPERIORITY||Geometric mean ratio|0.66|||<|0.05|TWO_SIDED|90.0|0.52|0.85||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.85|0.52|<0.05
73913950|NCT00042289|147357658|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73913951|NCT00042289|147357658|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73913952|NCT00042289|147357658|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
73913953|NCT00042289|147357658|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
73913954|NCT00042289|147357658|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73913955|NCT00042289|147357658|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73913956|NCT00042289|147357659|SUPERIORITY||Geometric mean ratio|0.97||||0.07|TWO_SIDED|90.0|0.83|1.13||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.13|0.83|0.07
73913957|NCT00042289|147357659|SUPERIORITY||Geometric mean ratio|0.77|||<|0.05|TWO_SIDED|90.0|0.61|0.96||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.96|0.61|<0.05
73913958|NCT00042289|147357659|SUPERIORITY||Geometric mean ratio|0.8|||<|0.05|TWO_SIDED|90.0|0.62|1.03||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.03|0.62|<0.05
73913959|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.81||||0.148|TWO_SIDED|90.0|0.64|1.01||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.01|0.64|0.148
73913960|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.71|||<|0.001|TWO_SIDED|90.0|0.62|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.81|0.62|<0.001
73913961|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.74||||0.0098|TWO_SIDED|90.0|0.61|0.89||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.61|0.0098
73913962|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.75||||0.0025|TWO_SIDED|90.0|0.64|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.88|0.64|0.0025
73913963|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.54|||<|0.0001|TWO_SIDED|90.0|0.46|0.64||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.64|0.46|<0.0001
73913964|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.56||||0.0024|TWO_SIDED|90.0|0.41|0.76||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.76|0.41|0.0024
73913965|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.795||||0.438|TWO_SIDED|90.0|0.499|1.269||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.269|0.499|0.438
73913966|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.531||||0.219|TWO_SIDED|90.0|0.186|1.512||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.512|0.186|0.219
73913967|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|1.05||||0.296|TWO_SIDED|90.0|0.94|1.18||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.18|0.94|0.296
73913968|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|1.26||||0.007|TWO_SIDED|90.0|1.01|1.56||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.56|1.01|0.007
73859230|NCT02436668|147264166|SUPERIORITY||Hazard Ratio (HR)|1.525|||<|0.0001|TWO_SIDED|95.0|1.241|1.873||P-value is from log-rank test stratified by the three randomization stratification factors \[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\].|Log Rank|||The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\] and with treatment as the only covariate.||1.873|1.241|<0.0001
73859231|NCT02436668|147264167|SUPERIORITY|P-value is based on log-rank test stratified by the three randomization stratification factors \[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\].|Hazard Ratio (HR)|1.109||||0.3225|TWO_SIDED|95.0|0.903|1.363|||Log Rank|||The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\] and with treatment as the only covariate.||1.363|0.903|0.3225
73859232|NCT02436668|147264169|SUPERIORITY||Risk Ratio (RR)|0.695||||0.0058|TWO_SIDED|95.0|0.535|0.903|||Cochran-Mantel-Haenszel|||For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo + Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.||0.903|0.535|0.0058
73859233|NCT02436668|147264171|SUPERIORITY||Risk Ratio (RR)|0.85||||0.0488|TWO_SIDED|95.0|0.722|1.0|||Cochran-Mantel-Haenszel||This 0.85 (0.722 to 1.0) with CI is referring to risk ratio not proportional/percentage of patients.|For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo+Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.||1.0|0.722|0.0488
73859234|NCT02436668|147264172|SUPERIORITY||Hazard Ratio (HR)|1.265||||0.0782|TWO_SIDED|95.0|0.975|1.642||P-value is from log-rank test stratified by the three randomization stratification factors.|Log Rank|||\[1\] Hazard ratio is based on a Cox proportional hazards model stratified by the three randomization stratification factors for time until definitive deterioration (TUDD1), a hazard ratio \< 1 favors Ibr + Gem/Abr. TUDD1 is defined as the time interval between randomization and the first occurrence of a decrease in score by \>= 10 points without any further improvement in score by \>= 10 points or any further available QoL data due to dropout after deterioration.||1.642|0.975|0.0782
73859235|NCT02436668|147264173|SUPERIORITY|||||||0.3343|||||||Chi-squared|||"For rate of VTEs, denominator is number of subjects in the Intent-to-Treat population and numerator is number of Intent-to-Treat subjects with at least one VTE observed any time on study. Confidence interval for rate of VTEs is based on Clopper-Pearson method.~\[1\] P value is based on Chi-square test."||||0.3343
73859236|NCT00405964|147264174|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Determined for site. P-value of \<.001 for treatment as well.|ANOVA|||||||<.001
73859237|NCT00405964|147264175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0||||Determined for site. Treatment p-value \<.001|ANOVA|||||||0.035
73859238|NCT00405964|147264176|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Same p-value for treatment and site.|ANOVA|||||||<.001
73859239|NCT00496197|147264255|SUPERIORITY_OR_OTHER||percentage of participants|83.7|||||TWO_SIDED|95.0|78.7|88.8|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT||88.8|78.7|
73859240|NCT00496197|147264256|SUPERIORITY_OR_OTHER||percentage of participants|93.0|||||TWO_SIDED|95.0|89.4|96.7|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOT||96.7|89.4|
73859241|NCT00496197|147264257|SUPERIORITY_OR_OTHER||percentage of participants|95.3|||||TWO_SIDED|95.0|92.3|98.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOT||98.3|92.3|
73859242|NCT00496197|147264258|SUPERIORITY_OR_OTHER||percentage of participants|88.5|||||TWO_SIDED|95.0|84.4|92.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV||92.6|84.4|
73859243|NCT00496197|147264259|SUPERIORITY_OR_OTHER||percentage of participants|93.1|||||TWO_SIDED|95.0|89.8|96.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOIV||96.4|89.8|
73859244|NCT00496197|147264260|SUPERIORITY_OR_OTHER||percentage of participants|92.6|||||TWO_SIDED|95.0|89.3|95.9|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOIV||95.9|89.3|
73859245|NCT00496197|147264261|SUPERIORITY_OR_OTHER||percentage of participants|76.3|||||TWO_SIDED|95.0|70.3|82.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up||82.3|70.3|
73859246|NCT00496197|147264262|SUPERIORITY_OR_OTHER||percentage of participants|94.8|||||TWO_SIDED|95.0|91.5|98.1|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 2 Follow-up||98.1|91.5|
74027002|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.81|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.46|0.81|
73859247|NCT00496197|147264263|SUPERIORITY_OR_OTHER||percentage of participants|95.4|||||TWO_SIDED|95.0|92.2|98.5|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 2 Follow-up||98.5|92.2|
73859248|NCT00496197|147264264|SUPERIORITY_OR_OTHER||percentage of participants|70.1|||||TWO_SIDED|95.0|63.5|76.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)||76.6|63.5|
73859249|NCT00496197|147264265|SUPERIORITY_OR_OTHER||percentage of participants|93.6|||||TWO_SIDED|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 6 Follow-up (EOS)||97.4|89.7|
73859250|NCT00496197|147264266|SUPERIORITY_OR_OTHER||percentage of participants|93.6|||||TWO_SIDED|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 6 Follow-up (EOS)||97.4|89.7|
73859251|NCT00496197|147264267|SUPERIORITY_OR_OTHER||percentage of participants|82.5|||||TWO_SIDED|95.0|75.7|89.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT||89.3|75.7|
73859252|NCT00496197|147264268|SUPERIORITY_OR_OTHER||percentage of participants|85.6|||||TWO_SIDED|95.0|79.8|91.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV||91.4|79.8|
73859253|NCT00496197|147264269|SUPERIORITY_OR_OTHER||percentage of participants|76.7|||||TWO_SIDED|95.0|69.0|84.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up||84.4|69.0|
73859254|NCT00496197|147264270|SUPERIORITY_OR_OTHER||percentage of participants|67.6|||||TWO_SIDED|95.0|58.9|76.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)||76.3|58.9|
73965549|NCT05687903|147466679|SUPERIORITY||IRR|0.28|||=|0.003|TWO_SIDED|95.0|0.13|0.6||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.60|0.13|=0.003
73965550|NCT05687903|147466679|SUPERIORITY||IRR|0.67|||=|0.25|TWO_SIDED|95.0|0.35|1.29||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||1.29|0.35|=0.250
73965551|NCT03494504|147466839|SUPERIORITY||Odds Ratio (OR)|2.36|||||TWO_SIDED|95.0|1.46|3.84||||||||3.84|1.46|
73859263|NCT01779869|147264340|SUPERIORITY|Accuracy was assessed compared to an imaging reference standard.||||||0.35|||||||Chi-squared|||Significance testing between the diagnostic accuracy of SPECT and PET, and SPECT and MR, and SPECT and PET/MR was performed by using chi square test. A P value \< 0.05 was considered significant.||||0.35
73859264|NCT00027378|147264341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|0.702||0.05||95.0|||||ANOVA|repeated measures||Repeated measures ANOVA||||.05
73859265|NCT01057225|147264393|SUPERIORITY_OR_OTHER||Dose Level|1.0|||||TWO_SIDED||||||||Using a cohort of 3 design, it was determined the maximum tolerated dose of carfilzomib is Dose Level 1: 20 mg/m\^2 for the first cycle and 36 mg/m\^2 for subsequent cycles.|||||
73859266|NCT00246025|147264412|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-16.8||||0.0155||95.0|-30.2|-3.4||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-3.4|-30.2|0.0155
73913969|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.83||||0.16|TWO_SIDED|90.0|0.56|1.22||2nd Trimester vs Postpartum|Wilcoxon signed rank test|||FPV was analyzed as the form of amprenavir (APV). FPV is the prodrug of APV.||1.22|0.56|0.16
73913970|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.74||||0.03|TWO_SIDED|90.0|0.58|0.93|||Wilcoxson signed rank test|||FPV was analyzed in the form of amprenavir (APV). FPV is the prodrug of APV.||0.93|0.58|0.03
73913971|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.86|||>|0.05|TWO_SIDED|90.0|0.68|1.08||3rd Trimester vs. Postpartum (No comparison was done for 2nd Trimester vs. Postpartum since the sample size for 2nd trimester was 1)|Wilcoxon signed rank test|||This analysis was for ATV.||1.08|0.68|>0.05
73913972|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.89||||0.1636|TWO_SIDED|90.0|0.79|1.01||Third Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)|Wilcoxon signed rank test|||||1.01|0.79|0.1636
73913973|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.69|||<|0.05|TWO_SIDED|90.0|0.53|0.91||3rd Trimester vs Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)|Wilcoxon signed rank test|||This analysis was for ATV.||0.91|0.53|<0.05
73913974|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|1.11||||0.16|TWO_SIDED|90.0|0.99|1.24||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since there was no Second Trimester data available)|Wilcoxon signed rank test|||||1.24|0.99|0.16
73913975|NCT00042289|147357660|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73913976|NCT00042289|147357660|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73913977|NCT00042289|147357660|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73913978|NCT00042289|147357660|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73913979|NCT00042289|147357660|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
73913980|NCT00042289|147357660|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
73913981|NCT00042289|147357660|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73913982|NCT00042289|147357660|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73859267|NCT00246025|147264412|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-23.7||||0.0006||95.0|-37.0|-10.5||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-10.5|-37.0|0.0006
73859268|NCT00246025|147264412|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-32.5|||<|0.0001||95.0|-45.4|-19.6||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-19.6|-45.4|<0.0001
73859269|NCT00246025|147264413|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||1.0|-9.1|0.1124
73859270|NCT00246025|147264413|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||1.1|-9.1|0.1183
73859271|NCT00246025|147264413|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-1.3|-10.3|0.0138
73859272|NCT00246025|147264414|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||1.0|-9.1|0.1124
73859273|NCT00246025|147264414|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||1.1|-9.1|0.1183
73859274|NCT00246025|147264414|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-1.3|-10.3|0.0138
73859275|NCT00246025|147264415|SUPERIORITY_OR_OTHER|||||||0.6107||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||0.6107
73859276|NCT00246025|147264415|SUPERIORITY_OR_OTHER|||||||1||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||1.0000
73859277|NCT00246025|147264415|SUPERIORITY_OR_OTHER|||||||0.6162||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||0.6162
73913983|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|1.06||||0.67|TWO_SIDED|90.0|0.85|1.34||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 2 participants had Second Trimester data)|Wilcoxon signed-rank test|||||1.34|0.85|0.67
73913984|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.73||||0.08|TWO_SIDED|90.0|0.59|0.91||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.91|0.59|0.08
73913985|NCT00042289|147357660|SUPERIORITY||Geometric mean of ratio|0.63|||<|0.01|TWO_SIDED|90.0|0.55|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.72|0.55|<0.01
73913986|NCT00042289|147357661|SUPERIORITY||Geometric mean of ratio|0.57|||<|0.05|TWO_SIDED|90.0|0.48|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.68|0.48|<0.05
73913987|NCT00042289|147357661|SUPERIORITY||Geometric mean of ratio|0.73|||<|0.05|TWO_SIDED|90.0|0.62|0.85||3rd Trimester vs.Postpartum|Wilcoxon signed rank test|||||0.85|0.62|<0.05
73913988|NCT00042289|147357661|SUPERIORITY|||||||0.09||||||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||||0.09
73913989|NCT00042289|147357661|SUPERIORITY|||||||0.003||||||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||||0.003
73913990|NCT00042289|147357661|SUPERIORITY||Geometric mean of ratio|1.34||||0.036|TWO_SIDED|||||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 5 participants had Second Trimester data)|Wilcoxon signed rank test|||||||0.036
73913991|NCT00042289|147357661|SUPERIORITY||Geometric mean of ratio|0.84|||>|0.05|TWO_SIDED|90.0|0.69|1.02||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.02|0.69|>0.05
73913992|NCT00042289|147357661|SUPERIORITY||Geometric mean of ratio|0.83|||>|0.05|TWO_SIDED|90.0|0.68|1.01||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.01|0.68|>0.05
73913993|NCT00042289|147357662|SUPERIORITY||Geometric mean of ratio|0.61||||0.14|TWO_SIDED|90.0|0.34|1.09||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.09|0.34|0.14
73913994|NCT00042289|147357662|SUPERIORITY||Geometric mean of ratio|0.64||||0.002|TWO_SIDED|90.0|0.5|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.81|0.50|0.002
73913995|NCT00042289|147357662|SUPERIORITY||Geometric mean of ratio|0.77||||0.24|TWO_SIDED|90.0|0.49|1.23||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.23|0.49|0.24
73913996|NCT00042289|147357662|SUPERIORITY||Geometric mean of ratio|0.84||||0.53|TWO_SIDED|90.0|0.6|1.17||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.17|0.60|0.53
73913997|NCT00042289|147357662|SUPERIORITY||Geometric mean of ratio|0.58||||0.2|TWO_SIDED|90.0|0.3|1.11||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.11|0.30|0.2
73913998|NCT00042289|147357662|SUPERIORITY||Geometric mean of ratio|0.95||||0.12|TWO_SIDED|90.0|0.58|1.55||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.55|0.58|0.12
73913999|NCT00042289|147357662|SUPERIORITY||Geometric mean of ratio|0.92||||0.358|TWO_SIDED|90.0|0.71|1.2||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.2|0.71|0.358
73914000|NCT00042289|147357662|SUPERIORITY||Geometric mean of ratio|0.72||||0.0156|TWO_SIDED|90.0|0.55|0.93||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.93|0.55|0.0156
73914001|NCT00042289|147357663|SUPERIORITY||Geometric mean of ratio|0.7||||0.007|TWO_SIDED|90.0|0.58|0.85||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since no Second Trimester data was available)|Wilcoxon signed rank test|||||0.85|0.58|0.007
73914002|NCT00042289|147357664|SUPERIORITY||Geometric mean ratio|0.66||||0.109|TWO_SIDED|90.0|0.39|1.12||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.12|0.39|0.109
73914003|NCT00042289|147357664|SUPERIORITY||Geometric mean ratio|0.58|||<|0.001|TWO_SIDED|90.0|0.49|0.69||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.69|0.49|<0.001
73914004|NCT00042289|147357664|SUPERIORITY||Geometric mean ratio|0.48||||0.44|TWO_SIDED|90.0|0.14|1.65||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.65|0.14|0.44
73914005|NCT00042289|147357664|SUPERIORITY||Geometric mean ratio|0.56|||<|0.001|TWO_SIDED|90.0|0.43|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.72|0.43|<0.001
73914006|NCT00042289|147357664|SUPERIORITY||Geometric mean ratio|0.83||||0.43|TWO_SIDED|90.0|0.63|1.1||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.10|0.63|0.43
73914007|NCT00042289|147357664|SUPERIORITY||Geometric mean ratio|1.0||||0.31|TWO_SIDED|90.0|0.69|1.44||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.44|0.69|0.31
73914008|NCT00042289|147357664|SUPERIORITY||Geometric mean ratio|0.9||||0.49|TWO_SIDED|90.0|0.71|1.16||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.16|0.71|0.49
73914009|NCT00042289|147357665|SUPERIORITY||Geometric mean ratio|0.45|||<|0.05|TWO_SIDED|90.0|0.32|0.63||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.63|0.32|<0.05
73914010|NCT00042289|147357665|SUPERIORITY||Geometric mean ratio|0.72|||<|0.05|TWO_SIDED|90.0|0.58|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.58|<0.05
73914011|NCT00042289|147357665|SUPERIORITY||Geometric mean ratio|0.42||||0.02|TWO_SIDED|90.0|0.23|0.78||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.78|0.23|0.02
73914012|NCT00042289|147357665|SUPERIORITY||Geometric mean ratio|0.78||||0.3|TWO_SIDED|90.0|0.56|1.08||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.08|0.56|0.3
73914013|NCT00042289|147357665|SUPERIORITY||Geometric mean ratio|1.41||||0.036|TWO_SIDED|||||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||||0.036
73914014|NCT00042289|147357665|SUPERIORITY||Geometric mean ratio|0.41|||<|0.05|TWO_SIDED|90.0|0.32|0.52||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.52|0.32|<0.05
73914015|NCT00042289|147357665|SUPERIORITY||Geometric mean ratio|0.48|||<|0.05|TWO_SIDED|90.0|0.41|0.57||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.57|0.41|<0.05
73914016|NCT00042289|147357666|SUPERIORITY||Geometric mean ratio|0.85||||0.1|TWO_SIDED|90.0|0.72|1.01||3rd Trimester vs. Postpartum|t-test, 2 sided|Paired sample t-test on natural log-transformed PK parameter||||1.01|0.72|0.10
73914017|NCT00042289|147357667|SUPERIORITY||Geometric mean ratio|0.49||||0.0039|TWO_SIDED|90.0|0.35|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.35|0.0039
73914018|NCT00042289|147357667|SUPERIORITY||Geometric mean ratio|0.66||||0.0062|TWO_SIDED|90.0|0.52|0.84||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.84|0.52|0.0062
73914019|NCT00042289|147357667|SUPERIORITY||||||<|0.1||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.10
73914020|NCT00042289|147357667|SUPERIORITY||||||<|0.1||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.10
73914021|NCT00042289|147357667|SUPERIORITY||Geometric mean ratio|0.15|||<|0.1|TWO_SIDED|90.0|0.08|0.3||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.30|0.08|<0.10
73914022|NCT00042289|147357667|SUPERIORITY||Geometric mean ratio|0.21|||<|0.1|TWO_SIDED|90.0|0.12|0.36||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.36|0.12|<0.10
73914023|NCT00042289|147357667|SUPERIORITY||Geometric mean ratio|0.32|||<|0.1|TWO_SIDED|90.0|0.2|0.51||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.51|0.20|<0.10
73914024|NCT00042289|147357667|SUPERIORITY||Geometric mean ratio|0.32|||>|0.1|TWO_SIDED|90.0|0.11|0.94||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.94|0.11|>0.10
73914025|NCT00042289|147357667|OTHER||Geometric mean ratio|0.87||||0.079|TWO_SIDED|90.0|0.78|0.97||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.97|0.78|0.079
73914026|NCT00042289|147357667|SUPERIORITY||Geometric mean ratio|0.92||||0.01|TWO_SIDED|90.0|0.77|1.09||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.09|0.77|0.01
73965552|NCT03494504|147466839|SUPERIORITY||Odds Ratio (OR)|1.81|||||TWO_SIDED|95.0|1.11|2.94||||||||2.94|1.11|
73914027|NCT00042289|147357667|SUPERIORITY||Geometric mean ratio|0.51|||<|0.05|TWO_SIDED|90.0|0.37|0.72||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.72|0.37|<0.05
73914028|NCT00042289|147357667|SUPERIORITY||Geometric mean ratio|0.82||||0.0325|TWO_SIDED|90.0|0.71|0.96||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.96|0.71|0.0325
73914029|NCT00042289|147357667|SUPERIORITY||Geometric mean ratio|0.65|||<|0.05|TWO_SIDED|90.0|0.54|0.77||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.77|0.54|<0.05
73914030|NCT00042289|147357667|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73914031|NCT00042289|147357667|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73914032|NCT00042289|147357667|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
73965553|NCT02879448|147466876|NON_INFERIORITY|The non-inferiority margin was developed based on reported rates for other devices. Therefore, the expected rate of the safety endpoint was assumed to be 15%. A non-inferiority margin of 5.8% represents a relative risk of 1.39.||||||0.0002|||||||Kaplan-Meier estimate|||"The following hypothesis was tested:~H0: p1(Amulet) - p1 (Watchman) ≥ Δ1~H1: p1(Amulet) - p1(Watchman) \< Δ1;~where Δ1 is the absolute value of the non-inferiority margin for the safety endpoint and p1 is the probability of a primary safety endpoint event."||||0.0002
73965554|NCT02879448|147466877|NON_INFERIORITY|The non-inferiority margin for this endpoint was developed based on the reported rates of ischemic stroke or systemic embolism for the Watchman. The 18-month rate of ischemic stroke or systemic embolism for the Watchman device has been reported in the literature as 4.2%. A non-inferiority margin of 3.2%, which represents a relative risk of 1.76, ensured that the rate observed was at most twice the rate expected with oral anticoagulant therapy.|||||<|0.0001|||||||Kaplan-Meier estimate|||"The following hypothesis was tested:~H0: p2(Amulet) - p2(Watchman) ≥ Δ2~H1: p2(Amulet) - p2(Watchman) \< Δ2;~where Δ2 is the absolute value of the non-inferiority margin for the effectiveness endpoint and p2 is the probability of a subject experiencing a primary effectiveness endpoint event."||||<0.0001
73965555|NCT02879448|147466878|NON_INFERIORITY|The non-inferiority margin for this endpoint was developed based on the reported closure rate for the Watchman device. The rate of device closure for the Watchman device has been reported in the literature as 95% (i.e., 5% had a residual jet \> 5mm). A non-inferiority margin of -3%, which represents a relative risk of 1.60, allows for trial to trial variability and implanter learning associated with implantation of a new device (Amulet).|||||<|0.0001|||||||Farrington Manning test|||"The following hypothesis was tested:~H0: p3(Amulet) - p3(Watchman) ≤ -Δ3~H1: p3(Amulet) - p3(Watchman) \> -Δ3;~where Δ3 is the absolute value of the non-inferiority margin and p3 is the 45-day closure probability."||||<0.0001
74027003|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.51|0.34|
74027004|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.66|1.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.09|0.66|
74027005|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.37|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.68|0.37|
74027006|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.43|0.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.77|0.43|
74088389|NCT00255151|147730207|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
73914033|NCT00042289|147357667|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
73914034|NCT00042289|147357667|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73914035|NCT00042289|147357667|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
73914036|NCT00042289|147357668|SUPERIORITY||Geometric mean ratio|0.88|||<|0.05|TWO_SIDED|90.0|0.73|1.06||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.06|0.73|<0.05
73914037|NCT00042289|147357668|SUPERIORITY||Geometric mean ratio|0.7|||<|0.05|TWO_SIDED|90.0|0.55|0.9||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.90|0.55|<0.05
73965556|NCT02879448|147466879|NON_INFERIORITY|"The following hypothesis was tested:~H1: p4(Amulet) - p4(Watchman) \< 4.5%"|||||<|0.0001|||||||Kaplan-Meier estimate|||||||<0.0001
73965557|NCT02879448|147466880|SUPERIORITY|"The following hypothesis was tested:~H1: p5(Amulet) - p5(Watchman) \< 0"||||||0.3229|||||||Kaplan-Meier estimate|||||||0.3229
73965558|NCT02879448|147466881|SUPERIORITY|"The following hypothesis was tested:~H1: p1(Amulet) - p1(Watchman) \< 0"||||||0.466|||||||Kaplan-Meier estimate|||||||0.4660
73965559|NCT02879448|147466882|SUPERIORITY|"The following hypothesis was tested:~H1: p2(Amulet) - p2(Watchman) \< 0"||||||0.5017|||||||Kaplan-Meier estimate|||||||0.5017
74085712|NCT01844531|147725643|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.25|STANDARD_ERROR_OF_MEAN|15.4||0.0006|TWO_SIDED|90.0|88.542|104.628|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||104.628|88.542|0.0006
74088390|NCT00255151|147730207|SUPERIORITY_OR_OTHER|||||||0.37161||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.37161
73914038|NCT00042289|147357668|SUPERIORITY||Geometric mean ratio|0.84|||<|0.05|TWO_SIDED|90.0|0.57|1.23||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.23|0.57|<0.05
73914039|NCT00042289|147357672|SUPERIORITY||Geometric mean of ratio|1.24||||0.114|TWO_SIDED|90.0|0.97|1.59||Before ENG initiation vs. after ENG initiation|Wilcoxon signed rank test|||The statistical analysis is for LPV PK.||1.59|0.97|0.114
73914040|NCT00042289|147357673|SUPERIORITY||Geometric mean of ratio|1.1||||0.367|TWO_SIDED|90.0|0.84|1.44||Before ENG initiation vs. after ENG initiation|Wilcoxon signed rank test|||The statistical test is for ATV PK.||1.44|0.84|0.367
73914041|NCT00042289|147357673|SUPERIORITY||Geometric mean of ratio|1.02||||0.561|TWO_SIDED|90.0|0.92|1.13|||Wilcoxon signed rank test|Before ENG initiation vs. after ENG initiation||The statistical test is for EFV PK.||1.13|0.92|0.561
73914042|NCT00745823|147357705|NON_INFERIORITY_OR_EQUIVALENCE|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.7||||0.044|TWO_SIDED|95.0|-10.7|-0.83|||Miettinen and Nurminen|||||-0.83|-10.7|0.044
73914043|NCT00745823|147357706|NON_INFERIORITY_OR_EQUIVALENCE|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.1||||0.011|TWO_SIDED|95.0|-9.29|-1.06|||Miettinen and Nurminen|||||-1.06|-9.29|0.011
73914044|NCT00745823|147357707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-5.0|4.6|||Miettinen and Nurminen|||||4.6|-5.0|
73914045|NCT00745823|147357708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.3|2.0||||||||2.0|-1.3|
73914046|NCT00745823|147357709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.56|||||TWO_SIDED|95.0|-7.29|34.4|||t-test, 2 sided|||||34.40|-7.29|
73914047|NCT01206660|147357715|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73914048|NCT01206660|147357716|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73914049|NCT01206660|147357717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73914050|NCT02955602|147357724|OTHER||||||=|0.2242|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 5 mg treatment groups after 8 weeks of treatment.||||= 0.2242
73914051|NCT02955602|147357724|OTHER||||||=|0.0021|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 10 mg treatment groups after 8 weeks of treatment||||= 0.0021
73914052|NCT02955602|147357724|OTHER||||||=|0.0024|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 5 mg and 10 mg treatment groups after 8 weeks of treatment||||= 0.0024
73914053|NCT03000439|147357743|OTHER||Hazard Ratio (HR)|0.633|||=|0.1171|TWO_SIDED|95.0|0.296|1.354||1-sided p-value is provided.|Unstratified log-rank test||Hazard ratio and 95% CI was based on Cox proportional hazards model with treatment group as covariate. Hazard ratio \< 1 indicates a reduction in hazard ratio in favor of Tofacitinib 5 mg BID to Placebo.|||1.354|0.296|= 0.1171
73914054|NCT03000439|147357744|OTHER||Difference in percentage|0.7|||||TWO_SIDED|95.0|-12.2|13.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 4||13.6|-12.2|
73914055|NCT03000439|147357744|OTHER||Difference in percentage|-8.3|||||TWO_SIDED|95.0|-27.9|11.3|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 8||11.3|-27.9|
73914056|NCT03000439|147357744|OTHER||Difference in percentage|-10.8|||||TWO_SIDED|95.0|-33.2|11.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 12||11.6|-33.2|
73914057|NCT03000439|147357744|OTHER||Difference in percentage|-13.7|||||TWO_SIDED|95.0|-37.2|9.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 16||9.8|-37.2|
73914058|NCT03000439|147357744|OTHER||Difference in percentage|-13.2|||||TWO_SIDED|95.0|-37.9|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 20||11.5|-37.9|
73914059|NCT03000439|147357744|OTHER||Difference in percentage|-13.2|||||TWO_SIDED|95.0|-37.9|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 24||11.5|-37.9|
73914060|NCT03000439|147357744|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-34.5|15.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 28||15.6|-34.5|
73914061|NCT03000439|147357744|OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-39.5|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 32||11.5|-39.5|
73914062|NCT03000439|147357744|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-35.5|16.7|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 36||16.7|-35.5|
73914063|NCT03000439|147357744|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-35.5|16.7|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 40||16.7|-35.5|
73914064|NCT03000439|147357744|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 44||11.8|-41.8|
73914065|NCT03000439|147357744|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 48||11.8|-41.8|
73914066|NCT03000439|147357744|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 52||11.8|-41.8|
73965560|NCT02879448|147466883|SUPERIORITY|"The following hypothesis was tested:~H1: p3(Amulet) - p3(Watchman) \> 0"||||||0.0025|||||||Farrington Manning test|||||||0.0025
73965561|NCT05952076|147466887|OTHER||Adjusted mean difference|0.11||||0.6863|TWO_SIDED|95.0|-0.44|0.67|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline WAZ and baseline age (days). A random intercept for participant was included.|||0.67|-0.44|0.6863
73965562|NCT05952076|147466888|OTHER||Adjusted mean difference|109.3||||0.5567|TWO_SIDED|95.0|-259.76|478.36|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline weight (grams) and baseline age (days). A random intercept for participant was included.|||478.36|-259.76|0.5567
73965563|NCT05952076|147466889|OTHER||Adjusted mean difference|0.1||||0.7275|TWO_SIDED|95.0|-0.46|0.66|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline WAZ, baseline age (days) and study intervention compliance. A random intercept for participant was included.|||0.66|-0.46|0.7275
73965564|NCT01704079|147466947|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73965565|NCT01704079|147466948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73965566|NCT01704079|147466949|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73965567|NCT01704079|147466950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73965568|NCT05986565|147466951|SUPERIORITY|||||||0.587|||||||RMANOVA|1||||||0.587
73965569|NCT05986565|147466952|SUPERIORITY|||||||0.874|||||||RMANOVA|1||||||0.874
73965570|NCT05986565|147466953|SUPERIORITY|||||||0.946|||||||RMANOVA|1||||||0.946
73965571|NCT05986565|147466954|SUPERIORITY|||||||0.267|||||||t-test, 2 sided|24||||||0.267
73965572|NCT05986565|147466955|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|df=25||||||0.187
74085713|NCT01844531|147725643|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|97.21|STANDARD_ERROR_OF_MEAN|15.1||0.0004|TWO_SIDED|90.0|89.41|105.68|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 (T1) : Empa12.5 + Met500 (R1), PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||105.68|89.41|0.0004
73965573|NCT05986565|147466956|SUPERIORITY|||||||0.765|||||||t-test, 2 sided|df=24||||||0.765
73965574|NCT05986565|147466957|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|df=25||||||0.060
73965575|NCT05986565|147466958|SUPERIORITY|||||||0.608|||||||t-test, 2 sided|df=24||||||0.608
73965576|NCT05986565|147466959|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|df=25||||||0.638
73914067|NCT03000439|147357747|OTHER||Difference in percentage|-11.41|||||TWO_SIDED|95.0|-28.02|5.21|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 4||5.21|-28.02|
73914068|NCT03000439|147357747|OTHER||Difference in percentage|1.5|||||TWO_SIDED|95.0|-18.37|21.36|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 8||21.36|-18.37|
73914069|NCT03000439|147357747|OTHER||Difference in percentage|0.46|||||TWO_SIDED|95.0|-22.68|23.6|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 12||23.60|-22.68|
73914070|NCT03000439|147357747|OTHER||Difference in percentage|10.14|||||TWO_SIDED|95.0|-13.82|34.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 16||34.10|-13.82|
73914071|NCT03000439|147357747|OTHER||Difference in percentage|16.24|||||TWO_SIDED|95.0|-8.43|40.92|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 20||40.92|-8.43|
73914072|NCT03000439|147357747|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 24||34.39|-15.49|
73914073|NCT03000439|147357747|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 28||34.33|-16.13|
73914074|NCT03000439|147357747|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 32||34.33|-16.13|
73914075|NCT03000439|147357747|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 36||34.33|-16.13|
73914076|NCT03000439|147357747|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 40||34.33|-16.13|
73914077|NCT03000439|147357747|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 44||34.33|-16.13|
73914078|NCT03000439|147357747|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 48||37.56|-12.91|
73914079|NCT03000439|147357747|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 52||37.56|-12.91|
73914080|NCT03000439|147357747|OTHER||Difference in percentage|-11.41|||||TWO_SIDED|95.0|-28.02|5.21|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 4||5.21|-28.02|
73914081|NCT03000439|147357747|OTHER||Difference in percentage|4.72|||||TWO_SIDED|95.0|-15.72|25.17|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 8||25.17|-15.72|
73965577|NCT00792636|147466975|SUPERIORITY_OR_OTHER||Least-squares mean|-1.7|||||TWO_SIDED|95.0|-3.2|-0.3|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.3|-3.2|
73965578|NCT00792636|147466975|SUPERIORITY_OR_OTHER||Least-squares mean|-0.9|||||TWO_SIDED|95.0|-2.2|0.3|||||Diastolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||0.3|-2.2|
73965579|NCT00792636|147466975|SUPERIORITY_OR_OTHER||Least-squares mean|-1.9|||||TWO_SIDED|95.0|-3.4|-0.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.4|-3.4|
73965580|NCT00792636|147466975|SUPERIORITY_OR_OTHER||Least-squares mean|-0.7|||||TWO_SIDED|95.0|-2.0|0.6|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||0.6|-2.0|
73965581|NCT00792636|147466976|SUPERIORITY_OR_OTHER||Least-squares mean|-2.1|||||TWO_SIDED|95.0|-3.4|-0.8|||||Systolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.8|-3.4|
73965582|NCT00792636|147466976|SUPERIORITY_OR_OTHER||Least-squares mean|-1.5|||||TWO_SIDED|95.0|-2.6|-0.3|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.3|-2.6|
73965583|NCT00792636|147466977|SUPERIORITY_OR_OTHER||Least-squares mean|0.4|||||TWO_SIDED|95.0|-1.6|2.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.4|-1.6|
73965584|NCT00792636|147466977|SUPERIORITY_OR_OTHER||Least-squares mean|0.5|||||TWO_SIDED|95.0|-1.2|2.2|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.2|-1.2|
73965585|NCT00792636|147466978|SUPERIORITY_OR_OTHER||Least-squares mean|0.3|||||TWO_SIDED|95.0|-1.7|2.2|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.2|-1.7|
74027007|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.3|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.60|0.30|
73965586|NCT00792636|147466978|SUPERIORITY_OR_OTHER||Least-squares mean|0.8|||||TWO_SIDED|95.0|-0.9|2.5|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.5|-0.9|
73965587|NCT00792636|147466983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.9|2.6||||||||2.6|0.9|
73965588|NCT00792636|147466983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.9|2.6||||||||2.6|0.9|
73965589|NCT00792636|147466984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||||1.7|0.6|
73965590|NCT00792636|147466984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.7|2.2||||||||2.2|0.7|
73965591|NCT00792636|147466985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.1|13.6||||||||13.6|0.1|
73965592|NCT00792636|147466985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|0.3|25.6||||||||25.6|0.3|
73965593|NCT00792636|147466986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.5|3.7||||||||3.7|0.5|
73965594|NCT00792636|147466986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.6|4.2||||||||4.2|0.6|
73965595|NCT00792636|147466987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.84|1.54||||||||1.54|0.84|
73965596|NCT00792636|147466987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|1.01|1.83||||||||1.83|1.01|
73965597|NCT00792636|147466988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.65|1.21||||||||1.21|0.65|
74027008|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.47|0.98|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.98|0.47|
74027009|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.72|1.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.01|0.72|
73965598|NCT00792636|147466988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.88|1.6||||||||1.60|0.88|
73965599|NCT01046136|147466990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0096|||||||Regression, Logistic|p-value is from a logistic regression model with terms for treatment group and center||Investigator's End-of-Study Assessment NOTE: All assessments of efficacy were considered exploratory and were given equal consideration, and were carried out on both the MITT and PP populations. LOCF method was applied to missing post baseline measurements in analyses of the MITT population.||||0.0096
73965600|NCT01046136|147466992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0293|||||||Wilcoxon (Mann-Whitney)|P-value is from a Wilcoxon rank sum test comparing the two treatment groups.||||||0.0293
73965601|NCT04110054|147467014|EQUIVALENCE|Placebo (N = 102) vs S-600918 50 mg, 150 mg, 300 mg||||||0.9334||||||P-value was evaluated at the 2-sided alpha level of 0.05.|ANCOVA|||The null hypotheses of equality between the treatment and placebo effects were tested using a mixed model, containing treatment group, week, and interaction between treatment groups and week as fixed effects; participant as random effect; and region and the common logarithm of the frequency of coughs per hour at baseline as covariates. Covariance structure was given as unstructured.||||0.9334
73965602|NCT00093015|147467025|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.41||95.0|0.94|1.17||Nominal p-value from a 2-sided log rank test is presented. The primary cardiovascular composite endpoint was tested at the 0.04056 significance level at final analysis after accounting for 4 planned interim analyses (overall alpha = 0.048).|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.17|0.94|0.41
73914082|NCT03000439|147357747|OTHER||Difference in percentage|0.46|||||TWO_SIDED|95.0|-22.68|23.6|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 12||23.60|-22.68|
73914083|NCT03000439|147357747|OTHER||Difference in percentage|13.36|||||TWO_SIDED|95.0|-10.76|37.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 16||37.48|-10.76|
73914084|NCT03000439|147357747|OTHER||Difference in percentage|19.47|||||TWO_SIDED|95.0|-5.2|44.14|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 20||44.14|-5.20|
73914085|NCT03000439|147357747|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 24||34.39|-15.49|
73914086|NCT03000439|147357747|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 28||34.33|-16.13|
73914087|NCT03000439|147357747|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 32||34.33|-16.13|
73914088|NCT03000439|147357747|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 36||34.33|-16.13|
73914089|NCT03000439|147357747|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 40||34.33|-16.13|
73914090|NCT03000439|147357747|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 44||37.56|-12.91|
74027010|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.71|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.00|0.71|
74027011|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.5|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.66|0.50|
74088391|NCT00255151|147730208|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
73914091|NCT03000439|147357747|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 48||37.56|-12.91|
73914092|NCT03000439|147357747|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 52||37.56|-12.91|
73914093|NCT03000439|147357747|OTHER||Difference in percentage|-13.82|||||TWO_SIDED|95.0|-38.14|10.49|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 4||10.49|-38.14|
73914094|NCT03000439|147357747|OTHER||Difference in percentage|-9.56|||||TWO_SIDED|95.0|-32.28|13.15|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 8||13.15|-32.28|
73914095|NCT03000439|147357747|OTHER||Difference in percentage|-0.23|||||TWO_SIDED|95.0|-24.7|24.24|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 12||24.24|-24.70|
73914096|NCT03000439|147357747|OTHER||Difference in percentage|5.88|||||TWO_SIDED|95.0|-19.31|31.06|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 16||31.06|-19.31|
73914097|NCT03000439|147357747|OTHER||Difference in percentage|19.12|||||TWO_SIDED|95.0|-5.81|44.06|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 20||44.06|-5.81|
73914098|NCT03000439|147357747|OTHER||Difference in percentage|1.96|||||TWO_SIDED|95.0|-23.55|27.47|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 24||27.47|-23.55|
73914099|NCT03000439|147357747|OTHER|The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|Difference in percentage|15.21|||||TWO_SIDED|95.0|-10.05|40.46|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 28||40.46|-10.05|
73914100|NCT03000439|147357747|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 32||37.56|-12.91|
73914101|NCT03000439|147357747|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 36||34.33|-16.13|
73914102|NCT03000439|147357747|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 40||37.56|-12.91|
73914103|NCT03000439|147357747|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 44||37.56|-12.91|
73914104|NCT03000439|147357747|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 48||37.56|-12.91|
73859278|NCT00246025|147264416|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-16.8||||0.0155|TWO_SIDED|95.0|-30.2|-3.4||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-3.4|-30.2|0.0155
73859279|NCT00246025|147264416|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-23.7||||0.0006|TWO_SIDED|95.0|-37.0|-10.5||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-10.5|-37.0|0.0006
73859280|NCT00246025|147264416|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-32.5|||<|0.0001|TWO_SIDED|95.0|-45.4|-19.6||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-19.6|-45.4|<.0001
73859281|NCT00246025|147264419|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||1.0000
73859282|NCT00246025|147264419|SUPERIORITY_OR_OTHER|||||||0.496||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||0.4960
73859283|NCT00246025|147264419|SUPERIORITY_OR_OTHER|||||||0.6223||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||0.6223
73859284|NCT00246025|147264419|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|-2.5||||0.1513|TWO_SIDED|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||1.0|-5.9|0.1513
73914105|NCT03000439|147357747|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 52||37.56|-12.91|
73914106|NCT03000439|147357747|OTHER||Difference in percentage|-19.82|||||TWO_SIDED|95.0|-44.09|4.46|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 4||4.46|-44.09|
73914107|NCT03000439|147357747|OTHER||Difference in percentage|-17.28|||||TWO_SIDED|95.0|-40.19|5.63|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 8||5.63|-40.19|
73965603|NCT00093015|147467026|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.29||95.0|0.95|1.19||Nominal p-value from a 2-sided log rank test is presented. The primary renal composite endpoint was tested at the 0.002 significance level at final analysis.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.19|0.95|0.29
74027012|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.56|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.80|0.56|
73859285|NCT00246025|147264419|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|-2.4||||0.1696|TWO_SIDED|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||1.0|-5.9|0.1696
73859286|NCT00246025|147264419|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|0.7||||0.7802|TWO_SIDED|95.0|-3.9|5.2|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||5.2|-3.9|0.7802
73859287|NCT00246025|147264419|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|1.7||||0.6313|TWO_SIDED|95.0|-5.3|8.7|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||8.7|-5.3|0.6313
73914108|NCT03000439|147357747|OTHER||Difference in percentage|-7.6|||||TWO_SIDED|95.0|-29.66|14.45|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 20||14.45|-29.66|
73914109|NCT03000439|147357747|OTHER||Difference in percentage|-13.71|||||TWO_SIDED|95.0|-37.19|9.77|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 12||9.77|-37.19|
73914110|NCT03000439|147357747|OTHER||Difference in percentage|-4.03|||||TWO_SIDED|95.0|-26.67|18.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 16||18.61|-26.67|
73914111|NCT03000439|147357747|OTHER||Difference in percentage|-14.75|||||TWO_SIDED|95.0|-35.32|5.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 32||5.83|-35.32|
73914112|NCT03000439|147357747|OTHER||Difference in percentage|-4.38|||||TWO_SIDED|95.0|-26.02|17.26|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 24||17.26|-26.02|
73859288|NCT00246025|147264419|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|2.3||||0.5377|TWO_SIDED|95.0|-4.9|9.4|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||9.4|-4.9|0.5377
73914113|NCT03000439|147357747|OTHER||Difference in percentage|-7.95|||||TWO_SIDED|95.0|-28.89|12.99|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 28||12.99|-28.89|
73914114|NCT03000439|147357747|OTHER||Difference in percentage|-6.91|||||TWO_SIDED|95.0|-30.65|16.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 36||16.83|-30.65|
73914115|NCT03000439|147357747|OTHER||Difference in percentage|-3.69|||||TWO_SIDED|95.0|-27.16|19.78|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 40||19.78|-27.16|
73914116|NCT03000439|147357747|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 44||22.68|-23.60|
74027013|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.54|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.69|0.54|
74027014|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.78|1.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.05|0.78|
74027015|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.59|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.80|0.59|
74088392|NCT00255151|147730208|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
73859289|NCT00246025|147264419|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|2.8||||0.4493|TWO_SIDED|95.0|-4.4|10.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||10.0|-4.4|0.4493
73859290|NCT04612842|147264455|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73859291|NCT02419131|147264466|SUPERIORITY|Superiority of the experimental arms (CBTH and CPT) compared to usual care (TAU)|Aggregated contrast CBTH to TAU|-3.4|||<|0.001|TWO_SIDED|95.0|-5.4|-1.4||p-value represents an aggregate of post-treatment outcomes (i.e., post-treatment, 3-month, and 6-month outcomes entered simultaneously into the GLMM to represent a single metric of all post-treatment assessment intervals into one estimate).|Mixed Models Analysis|Outcome observations at posttreatment, 3-month and 6-month follow-ups were entered simultaneously into the mixed model to provide a single inference.|Contrast of aggregated post-treatment outcomes of HIT-6 total score for CBTH compared to TAU|Sample size based on 2-tailed specified joint superiority testing of 2 primary outcomes at α = .025 and power of 0.80 to detect an effect size (d) of 0.52 for both primary outcomes (representing a clinically significant change of 2.8 points on the HIT-6). The primary analysis set was intention to treat (ITT). multiple imputation accounted for missing data in ITT. Missing outcome scores at posttreatment, 3-month, and 6-month follow-ups were multiply imputed (m = 100) using multilevel models.||-1.4|-5.4|<0.001
73859292|NCT02419131|147264466|SUPERIORITY|See previous section for analysis|Aggregated contrast CPT to TAU|-1.4||||0.21|TWO_SIDED|95.0|-3.7|0.8||For comparison of post-treatment HIT-6 total score between CPT and TAU|Mixed Models Analysis|See above for details.|See above.|See previous section for power||0.8|-3.7|0.21
73859293|NCT02419131|147264467|SUPERIORITY|Key parameters and details the same as HIT-6 described above.|Aggregated contrast CBTH to TAU|-6.5||||0.04|TWO_SIDED|95.0|-12.7|-0.3||Contrast of aggregate post-treatment outcomes between CBTH and TAU|Mixed Models Analysis|Contrast of aggregate post-treatment outcomes between CBTH and TAU||Same sample size calculation as HIT-6 analyses, powered to detect a difference of 8.2 points on the PCL-5 total score.||-0.3|-12.7|0.04
73859294|NCT02419131|147264467|SUPERIORITY|Contrast of aggregate post-treatment outcomes between CPT and TAU|Aggregated contrast CPT to TAU|-8.9||||0.01|TWO_SIDED|95.0|-15.9|-1.9||Contrast of aggregate post-treatment outcomes between CPT and TAU|Mixed Models Analysis|Contrast of aggregate post-treatment outcomes between CPT and TAU||See above.||-1.9|-15.9|0.01
73859295|NCT02437305|147264502|SUPERIORITY_OR_OTHER|||||||0.048||||||P-value compares the increase in skin self-exams from pre-intervention to 2-months follow-up between the 2 groups.|McNemar|||||||0.048
73859296|NCT02437305|147264503|SUPERIORITY_OR_OTHER||||||>|0.5||||||P-value compares the increase in knowledge from pre-intervention to 2-months follow-up between the 2 groups.|McNemar|||||||>0.50
73859297|NCT01071200|147264521|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon two sample test|||Change at hCG day : Wilcoxon two sample test was used to calculate p-value.||||0.07
73914117|NCT03000439|147357747|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 48||22.68|-23.60|
73914118|NCT03000439|147357747|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 52||22.68|-23.60|
73914119|NCT03000439|147357747|OTHER||Difference in percentage|-21.2|||||TWO_SIDED|95.0|-42.45|0.05|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 4||0.05|-42.45|
73914120|NCT03000439|147357747|OTHER||Difference in percentage|-18.32|||||TWO_SIDED|95.0|-37.98|1.34|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 8||1.34|-37.98|
73965604|NCT00093015|147467027|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.48||95.0|0.92|1.21||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.21|0.92|0.48
73965605|NCT00093015|147467028|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.61||95.0|0.88|1.25||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.25|0.88|0.61
74027016|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.53|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.83|0.53|
74027017|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.51|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.74|0.51|
74027018|NCT01025336|147607525|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.15|0.75|
74027019|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|6.05|10.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.67|6.05|
74085714|NCT01844531|147725643|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.79|STANDARD_ERROR_OF_MEAN|9.8||0|TWO_SIDED|90.0|91.772|102.093|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||102.093|91.772|0.0000
74085715|NCT01844531|147725643|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.91|STANDARD_ERROR_OF_MEAN|9.8|<|0.0001|TWO_SIDED|90.0|91.79|102.32|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||102.32|91.79|<.0001
74085716|NCT01844531|147725644|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.0|STANDARD_ERROR_OF_MEAN|8.5||0|TWO_SIDED|90.0|93.53|102.686|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||102.686|93.530|0.0000
74085717|NCT01844531|147725644|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.07|STANDARD_ERROR_OF_MEAN|8.5|<|0.0001|TWO_SIDED|90.0|93.55|102.81|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||102.81|93.55|<.0001
73859298|NCT03730961|147264538|SUPERIORITY|Drug - placebo|Mean Difference (Net)|-448.0||||0.0021|TWO_SIDED|95.0|-714.0|-183.0|||t-test, 2 sided|||||-183|-714|0.0021
73859299|NCT03730961|147264538|SUPERIORITY|Percent change Drug - placebo|Mean Difference (Net)|-22.1||||0.0222|TWO_SIDED|95.0|-40.7|-3.51|||t-test, 2 sided|||||-3.51|-40.7|0.0222
73859300|NCT03730961|147264539|SUPERIORITY|Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|-4.25||||0.0163|TWO_SIDED|95.0|-7.63|-0.876|||t-test, 2 sided|||||-0.876|-7.63|0.0163
73859301|NCT03730961|147264539|SUPERIORITY|Percent change Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|-15.0||||0.2018|TWO_SIDED|95.0|-38.8|8.77|||t-test, 2 sided|||||8.77|-38.8|0.2018
73859302|NCT03730961|147264539|SUPERIORITY|Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|-3.61||||0.0526|TWO_SIDED|95.0|-7.27|0.0446|||t-test, 2 sided|||||0.0446|-7.27|0.0526
73859303|NCT03730961|147264539|SUPERIORITY|Percent change Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|-14.9||||0.2076|TWO_SIDED|95.0|-38.8|9.0|||t-test, 2 sided|||||9|-38.8|0.2076
73859304|NCT03730961|147264540|SUPERIORITY|Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|0.431||||0.1621|TWO_SIDED|95.0|-0.189|1.05|||t-test, 2 sided|||||1.05|-0.189|0.1621
73859305|NCT03730961|147264540|SUPERIORITY|Percent change Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|32.0||||0.0338|TWO_SIDED|95.0|2.72|61.3|||t-test, 2 sided|||||61.3|2.72|0.0338
73859306|NCT03730961|147264540|SUPERIORITY|Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|0.766||||0.06|TWO_SIDED|95.0|-0.0353|1.57|||t-test, 2 sided|||||1.57|-0.0353|0.0600
73859307|NCT03730961|147264540|SUPERIORITY|Percent change Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|33.5||||0.028|TWO_SIDED|95.0|4.02|63.0|||t-test, 2 sided|||||63|4.02|0.0280
73859308|NCT03730961|147264543|SUPERIORITY||Difference between drug and placebo|-4.0|STANDARD_DEVIATION|4.74||||||||||||||||
73859309|NCT03410797|147264555|OTHER|Due to small sample size, nonparametric Wilcoxon signed-rank tests were used to compare VHI-10 before and after therapy.|Median Difference (Net)|7.0||||0.0076|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Descriptive statistics characterized this patient perception measurement.||||.0076
73859310|NCT03410797|147264556|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Final Values)|-1.53||||0.0329|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0329
73965606|NCT00093015|147467029|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.96||||0.73||95.0|0.75|1.23||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.23|0.75|0.73
73859311|NCT03410797|147264557|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|15.39||||0.0164|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0164
73859312|NCT03410797|147264558|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|-52.0||||0.1141|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1141
73859313|NCT03410797|147264559|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|-1.7||||0.3329|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.3329
73859314|NCT01527513|147264561|NON_INFERIORITY_OR_EQUIVALENCE|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|Mean Difference (Final Values)|33.2001||||0.7|TWO_SIDED|95.0|-137.593|203.993|||95% CI lower bound vs non-inf margin|||||203.993|-137.593|0.700
73859315|NCT01527513|147264562|NON_INFERIORITY_OR_EQUIVALENCE|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|95% CI lower bound vs non-inf margin|33.2001|||<|0.7|TWO_SIDED|95.0|-137.593|203.993|||ANCOVA||The predefined non-inferiority margin was -121ms.|||203.993|-137.593|<0.700
73859316|NCT01185964|147264564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.672||||0.0615|TWO_SIDED|95.0|0.442|1.021|||Log Rank|||||1.021|0.442|0.0615
73859317|NCT01185964|147264567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.463||||0.0003|TWO_SIDED|95.0|0.301|0.71|||Log Rank|||||0.710|0.301|0.0003
73859318|NCT01920893|147264575|SUPERIORITY||Least Square (LS) mean difference|-1.55||||0.0009|TWO_SIDED|95.0|-2.43|-0.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg QW vs Placebo|Analysis was performed by a mixed model repeated measures (MMRM) model.||-0.67|-2.43|0.0009
73859319|NCT04465877|147264590|SUPERIORITY||Mean Difference (Final Values)|-2.12||||0.956|TWO_SIDED|95.0|-79.67|75.42|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 1||75.42|-79.67|0.956
73859320|NCT04465877|147264590|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.995|TWO_SIDED|95.0|-105.41|106.07|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 14||106.07|-105.41|0.995
73965607|NCT00093015|147467030|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.92|||<|0.001||95.0|1.38|2.68||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||2.68|1.38|<0.001
73965608|NCT00093015|147467031|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.89||||0.24||95.0|0.74|1.08||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.08|0.74|0.24
73965609|NCT00093015|147467032|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.02||||0.83||95.0|0.87|1.18||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.18|0.87|0.83
73859321|NCT04465877|147264590|SUPERIORITY||Mean Difference (Final Values)|-59.35||||0.366|TWO_SIDED|95.0|-191.15|72.45|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 28||72.45|-191.15|0.366
73859322|NCT04465877|147264590|SUPERIORITY||Mean Difference (Final Values)|-100.02||||0.016|TWO_SIDED|95.0|-179.96|-20.08|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 1||-20.08|-179.96|0.016
73859323|NCT04465877|147264590|SUPERIORITY||Mean Difference (Final Values)|-137.85||||0.014|TWO_SIDED|95.0|-245.28|-30.43|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 14||-30.43|-245.28|0.014
73859324|NCT04465877|147264590|SUPERIORITY||Mean Difference (Final Values)|-229.04||||0.001|TWO_SIDED|95.0|-362.17|-95.91|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 28||-95.91|-362.17|0.001
73859325|NCT04465877|147264590|SUPERIORITY||Mean Difference (Final Values)|-89.98||||0.025|TWO_SIDED|95.0|-167.62|-12.33|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 1||-12.33|-167.62|0.025
73914121|NCT03000439|147357747|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 12||8.61|-31.65|
73914122|NCT03000439|147357747|OTHER||Difference in percentage|-7.95|||||TWO_SIDED|95.0|-28.89|12.99|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 16||12.99|-28.89|
73914123|NCT03000439|147357747|OTHER||Difference in percentage|1.38|||||TWO_SIDED|95.0|-16.15|18.91|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 20||18.91|-16.15|
73914124|NCT03000439|147357747|OTHER||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-21.36|18.37|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 24||18.37|-21.36|
73914125|NCT03000439|147357747|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 28||11.32|-27.91|
73914126|NCT03000439|147357747|OTHER||Difference in percentage|-15.09|||||TWO_SIDED|95.0|-34.29|4.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 32||4.10|-34.29|
73914127|NCT03000439|147357747|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 36||8.61|-31.65|
73914128|NCT03000439|147357747|OTHER||Difference in percentage|-7.6|||||TWO_SIDED|95.0|-29.66|14.45|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 40||14.45|-29.66|
73914129|NCT03000439|147357747|OTHER||Difference in percentage|-4.38|||||TWO_SIDED|95.0|-26.02|17.26|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 44||17.26|-26.02|
73914130|NCT03000439|147357747|OTHER||Difference in percentage|-0.81|||||TWO_SIDED|95.0|-23.04|21.43|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 48||21.43|-23.04|
73914131|NCT03000439|147357747|OTHER||Difference in percentage|-0.81|||||TWO_SIDED|95.0|-23.04|21.43|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 52||21.43|-23.04|
73914132|NCT03000439|147357755|OTHER||Difference in percentage|-7.83|||||TWO_SIDED|95.0|-23.42|7.75|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||7.75|-23.42|
73914133|NCT03000439|147357755|OTHER||Difference in percentage|5.07|||||TWO_SIDED|95.0|-13.94|24.08|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||24.08|-13.94|
73914134|NCT03000439|147357755|OTHER||Difference in percentage|0.81|||||TWO_SIDED|95.0|-21.43|23.04|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||23.04|-21.43|
73965610|NCT00093015|147467033|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.12||||0.54||95.0|-0.51|0.26||Nominal p-value is from the term treatment group\*visit in the mixed model.|Mixed Models Analysis|Adjusted for baseline eGFR and the stratification factors of proteinuria and CVD history.|Estimated difference in rate of decline in eGFR per year between darbepoetin alfa and placebo.|||0.26|-0.51|0.54
73914135|NCT03000439|147357755|OTHER||Difference in percentage|10.14|||||TWO_SIDED|95.0|-13.82|34.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||34.10|-13.82|
73914136|NCT03000439|147357755|OTHER||Difference in percentage|16.24|||||TWO_SIDED|95.0|-8.43|40.92|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||40.92|-8.43|
73914137|NCT03000439|147357755|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||34.39|-15.49|
73965611|NCT00093015|147467034|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|0.35|<|0.001||95.0|0.64|2.02||Nominal p-value is presented.|t-test, 2 sided||Difference (darbepoetin alfa - placebo)|||2.02|0.64|<0.001
73914138|NCT03000439|147357755|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||34.33|-16.13|
73914139|NCT03000439|147357755|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||34.33|-16.13|
73914140|NCT03000439|147357755|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||34.33|-16.13|
73914141|NCT03000439|147357755|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||34.33|-16.13|
73914142|NCT03000439|147357755|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||34.33|-16.13|
73914143|NCT03000439|147357755|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||37.56|-12.91|
73914144|NCT03000439|147357755|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||37.56|-12.91|
73914145|NCT03000439|147357761|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-2.4|2.38||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.38|-2.40|
73965612|NCT00093015|147467035|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.84||||0.4||95.0|0.55|1.27||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.27|0.55|0.40
73965613|NCT00632203|147467038|SUPERIORITY_OR_OTHER|||||||0.6995|||||||2-sided Exact Pearson Chi-square Test|||||||0.6995
73965614|NCT02641912|147467045|SUPERIORITY_OR_OTHER||Least sqaure (LS) mean difference|0.63||||0.0084|TWO_SIDED|95.0|0.17|1.1|||ANOVA|From ANOVA model with factors for treatment and confirmed Sjögren's syndrome status stratification using Observed Margins option.|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|||1.10|0.17|0.0084
73965615|NCT00448669|147467078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Regression, Cox|||Safety analyses were performed in the intention-to-treat cohort. Primary safety end points included the frequency of adverse clinical or laboratory events.||||0.003
73965616|NCT00448669|147467079|SUPERIORITY_OR_OTHER_LEGACY||Efficacy|62.2||||0.03|TWO_SIDED|95.0|21.5|83.4|||Regression, Cox|||The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The primary hypothesis was that TDF-FTC, as compared with placebo, would reduce the rate of HIV infection by at least 65%, with a predefined lower boundary for the 95% confidence interval of 10%.||83.4|21.5|0.03
73965617|NCT00448669|147467080|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.004|TWO_SIDED|95.0|1.05|1.28|||Regression, Logistic|In this univariate model with the analysis of number of condomless sex acts, our model estimates the odds of reporting no condomless sex acts.||"A logistic regression was used to estimate the odds of reporting zero condomless sex acts. The longitudinal dependent variable (number of condomless sex acts) was defined as:~Number of condomless vaginal sexual acts with both casual and main partners among those who reported having had at least one sexual partner in the previous 30 days."||1.28|1.05|0.004
73965618|NCT00448669|147467081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Fisher Exact|||Fisher's Exact Test was performed to test for differences between the treatment groups in terms of adherence based on pill count.||||0.79
73965619|NCT01340066|147467154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.92|ONE_SIDED|80.0|||||Chi-squared|||||||.92
73965620|NCT02395978|147467171|SUPERIORITY|||||||0.393|||||||Kruskal-Wallis|||||||0.393
73965621|NCT03338816|147467196|SUPERIORITY||Rate ratio|0.26|||<|0.0001|TWO_SIDED|95.0|0.16|0.41||P=6.040E-09|Negative binomial regression model|||Negative binomial regression model with treatment group and stratification factors (prior hemin prophylaxis status and historical attack rates) as fixed effects and the logarithm of the follow-up time as an offset variable.||0.41|0.16|<0.0001
73965622|NCT04238247|147467229|SUPERIORITY||Odds Ratio (OR)|1.876119||||0.006|TWO_SIDED|95.0|1.193531|2.949084||The threshold for statistical significance was p = 0.05.|Regression, Logistic|We conducted logistic regression adjusted for randomization strata (recommended CRS and reason for eligibility).||We hypothesized the intervention group would have greater child passenger safety guideline adherence at 6 months compared with enhanced usual care group. In planning the trial, we assumed 75% of TCBD caregivers would be re-randomized. Baseline randomization was stratified by recommended CRS (rear-facing seat, forward-facing seat, booster seat) and reason for eligibility (not using the recommended CRS at baseline or planning a premature transition in the next 6 months).||2.949084|1.193531|0.006
73965623|NCT04238247|147467230|SUPERIORITY||Odds Ratio (OR)|0.8686678||||0.671|TWO_SIDED|95.0|0.4535589|1.663695||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||This analysis is limited to the Phase 2 participants who were re-randomized at 6 months to test the hypothesis that the enhanced intervention (with booster MI session) would have greater guideline adherent child passenger safety behaviors at 12 month follow-up than the group that continued in the basic intervention (mHealth components).||1.663695|0.4535589|0.671
73965624|NCT04238247|147467230|SUPERIORITY||Odds Ratio (OR)|6.859599|||<|0.001|TWO_SIDED|95.0|3.173121|14.82896|||Regression, Logistic|||||14.82896|3.173121|<0.001
73859326|NCT04465877|147264590|SUPERIORITY||Mean Difference (Final Values)|-222.02|||<|0.001|TWO_SIDED|95.0|-326.54|-117.51|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 14||-117.51|-326.54|<0.001
73859327|NCT04465877|147264590|SUPERIORITY||Mean Difference (Final Values)|-248.82|||<|0.001|TWO_SIDED|95.0|-379.35|-118.28|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 28||-118.28|-379.35|<0.001
73859328|NCT05894538|147264591|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.92|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.92|
73859329|NCT05894538|147264592|SUPERIORITY|Due to the low event rate, a posterior probability was not estimated.|Hazard Ratio (HR)|3.57|||||TWO_SIDED|95.0|0.74|17.18|||||Low event rate precluded covariate adjustment.|||17.18|0.74|
73859330|NCT05894538|147264595|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.6|1.45|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.45|0.60|
73859331|NCT05894538|147264599|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||0.96|0.61|
73859332|NCT05894538|147264599|OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.49|0.85|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||0.85|0.49|
73859333|NCT05894538|147264599|OTHER||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||0.92|0.52|
74027020|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.3|||||TWO_SIDED|95.0|6.65|10.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.45|6.65|
74027021|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.8|||||TWO_SIDED|95.0|3.71|6.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.14|3.71|
74027022|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.2|||||TWO_SIDED|95.0|2.59|3.91|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.91|2.59|
73859334|NCT05894538|147264599|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.72|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.36|0.72|
73859335|NCT05894538|147264600|OTHER||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|1.03|1.56|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.56|1.03|
73859336|NCT05894538|147264600|OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|1.0|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.51|1.00|
73859337|NCT05894538|147264600|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.87|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.35|0.87|
73859338|NCT05894538|147264600|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.86|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.32|0.86|
73859339|NCT05894538|147264601|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.81|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.26|0.81|
73859340|NCT05894538|147264601|OTHER||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|1.0|1.66|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.66|1.00|
73859341|NCT05894538|147264601|OTHER||Odds Ratio (OR)|1.52|||||TWO_SIDED|95.0|1.15|2.02|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||2.02|1.15|
73859342|NCT05894538|147264601|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.86|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.47|0.86|
73859343|NCT05894538|147264602|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.76|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.24|0.76|
73859344|NCT05894538|147264602|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.75|1.3|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.30|0.75|
73859345|NCT05894538|147264602|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.25|0.72|
73859346|NCT05894538|147264602|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.28|0.75|
73859347|NCT05894538|147264603|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.33|0.84|
73859348|NCT05894538|147264603|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.87|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.43|0.87|
73859349|NCT05894538|147264603|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.91|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.55|0.91|
73859350|NCT05894538|147264603|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.26|0.75|
74088393|NCT00255151|147730208|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.59700
74027023|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.4|||||TWO_SIDED|95.0|3.67|5.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.26|3.67|
74027024|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.6|||||TWO_SIDED|95.0|2.2|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.14|2.20|
73914146|NCT03000439|147357761|OTHER||Difference in LS Mean|0.94|||||TWO_SIDED|95.0|-2.25|4.12||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.12|-2.25|
73914147|NCT03000439|147357761|OTHER||Difference in LS Mean|-0.24|||||TWO_SIDED|95.0|-4.54|4.06||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.06|-4.54|
73914148|NCT03000439|147357761|OTHER||Difference in LS Mean|-0.86|||||TWO_SIDED|95.0|-3.99|2.28||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.28|-3.99|
73914149|NCT03000439|147357761|OTHER||Difference in LS Mean|-1.09|||||TWO_SIDED|95.0|-3.12|0.94||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.94|-3.12|
73914150|NCT03000439|147357761|OTHER||Difference in LS Mean|0.3|||||TWO_SIDED|95.0|-1.46|2.06||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.06|-1.46|
73914151|NCT03000439|147357761|OTHER||Difference in LS Mean|-1.28|||||TWO_SIDED|95.0|-7.85|5.29||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.29|-7.85|
73914152|NCT03000439|147357761|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-1.98|2.93||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.93|-1.98|
73914153|NCT03000439|147357761|OTHER||Difference in LS Mean|-0.26|||||TWO_SIDED|95.0|-1.86|1.35||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.35|-1.86|
73914154|NCT03000439|147357761|OTHER||Difference in LS Mean|0.73|||||TWO_SIDED|95.0|-2.18|3.63||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.63|-2.18|
73914155|NCT03000439|147357761|OTHER||Difference in LS Mean|-0.83|||||TWO_SIDED|95.0|-3.22|1.56||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.56|-3.22|
73914156|NCT03000439|147357761|OTHER||Difference in LS Mean|-0.23|||||TWO_SIDED|95.0|-1.76|1.3||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-1.76|
74027025|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.9|||||TWO_SIDED|95.0|7.8|21.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||21.34|7.80|
73914157|NCT03000439|147357761|OTHER||Difference in LS Mean|-0.75|||||TWO_SIDED|95.0|-3.43|1.93||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.93|-3.43|
73914158|NCT03000439|147357762|OTHER||Difference in LS Mean|0.9|||||TWO_SIDED|95.0|-1.8|3.61||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.61|-1.80|
73914159|NCT03000439|147357762|OTHER||Difference in LS Mean|2.11|||||TWO_SIDED|95.0|-0.64|4.86||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.86|-0.64|
73914160|NCT03000439|147357762|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-4.25|4.21||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.21|-4.25|
73914161|NCT03000439|147357762|OTHER||Difference in LS Mean|-1.12|||||TWO_SIDED|95.0|-4.32|2.09||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.09|-4.32|
73914162|NCT03000439|147357762|OTHER||Difference in LS Mean|-0.53|||||TWO_SIDED|95.0|-3.04|1.98||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.98|-3.04|
73914163|NCT03000439|147357762|OTHER||Difference in LS Mean|1.84|||||TWO_SIDED|95.0|-1.29|4.97||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.97|-1.29|
73914164|NCT03000439|147357762|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-5.89|5.72||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.72|-5.89|
74085718|NCT01844531|147725644|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.77|STANDARD_ERROR_OF_MEAN|6.5||0|TWO_SIDED|90.0|99.146|106.522|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.522|99.146|0.0000
74085719|NCT01844531|147725644|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.49|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|90.0|98.85|106.25|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.25|98.85|<.0001
73859351|NCT05894538|147264604|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.20|0.79|
73859352|NCT05894538|147264604|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.63|1.02|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.02|0.63|
73859353|NCT05894538|147264604|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.69|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.69|
73859354|NCT05894538|147264604|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.35|0.84|
73859355|NCT05894538|147264605|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.78|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.19|0.78|
73859356|NCT05894538|147264605|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.92|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.39|0.92|
73859357|NCT05894538|147264605|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.91|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.36|0.91|
73859358|NCT05894538|147264605|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.82|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.21|0.82|
73859359|NCT05894538|147264606|SUPERIORITY||Difference in model estimate time unwell|-0.04|||||TWO_SIDED|95.0|-0.39|0.32|||||The interval is a highest-density credible interval.|||0.32|-0.39|
73859360|NCT02323204|147264613|OTHER|||||||0.6298|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.6298
73859361|NCT02323204|147264613|OTHER|||||||0.2341|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2341
73914165|NCT03000439|147357762|OTHER||Difference in LS Mean|-0.69|||||TWO_SIDED|95.0|-3.79|2.41||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.41|-3.79|
73914166|NCT03000439|147357762|OTHER||Difference in LS Mean|-0.35|||||TWO_SIDED|95.0|-1.89|1.19||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.19|-1.89|
73914167|NCT03000439|147357762|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-3.63|3.58||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.58|-3.63|
73914168|NCT03000439|147357762|OTHER||Difference in LS Mean|-2.59|||||TWO_SIDED|95.0|-5.67|0.49||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.49|-5.67|
73914169|NCT03000439|147357762|OTHER||Difference in LS Mean|-0.82|||||TWO_SIDED|95.0|-2.82|1.19||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.19|-2.82|
73914170|NCT03000439|147357762|OTHER||Difference in LS Mean|-0.46|||||TWO_SIDED|95.0|-3.27|2.36||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.36|-3.27|
73914171|NCT03000439|147357775|OTHER||Difference in LS Mean|0.86|||||TWO_SIDED|95.0|-0.08|1.79||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.79|-0.08|
73914172|NCT03000439|147357775|OTHER||Difference in LS Mean|1.32|||||TWO_SIDED|95.0|0.25|2.4||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.40|0.25|
73914173|NCT03000439|147357775|OTHER||Difference in LS Mean|1.43|||||TWO_SIDED|95.0|-0.79|3.66||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||3.66|-0.79|
73914174|NCT03000439|147357775|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-0.7|0.74||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.74|-0.70|
73914175|NCT03000439|147357775|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.43|0.64||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.64|-0.43|
73914176|NCT03000439|147357775|OTHER||Difference in LS Mean|0.44|||||TWO_SIDED|95.0|0.06|0.81||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.81|0.06|
73914177|NCT03000439|147357775|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-1.64|2.06||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.06|-1.64|
73914178|NCT03000439|147357775|OTHER||Difference in LS Mean|0.49|||||TWO_SIDED|95.0|-0.04|1.03||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.03|-0.04|
73914179|NCT03000439|147357775|OTHER||Difference in LS Mean|0.35|||||TWO_SIDED|95.0|-0.09|0.79||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.79|-0.09|
73914180|NCT03000439|147357775|OTHER||Difference in LS Mean|0.52|||||TWO_SIDED|95.0|-0.23|1.28||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.28|-0.23|
73914181|NCT03000439|147357775|OTHER||Difference in LS Mean|-0.19|||||TWO_SIDED|95.0|-1.2|0.83||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.83|-1.20|
73965625|NCT04238247|147467233|SUPERIORITY||Odds Ratio (OR)|1.74029||||0.032|TWO_SIDED|95.0|1.049169|2.886676||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||2.886676|1.049169|0.032
73965626|NCT04238247|147467234|SUPERIORITY||Odds Ratio (OR)|1.112874||||0.752|TWO_SIDED|95.0|0.5735782|2.159233||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||2.159233|0.5735782|0.752
73914182|NCT03000439|147357775|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.49|0.91||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.91|-0.49|
73914183|NCT03000439|147357775|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.8|0.92||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.92|-0.80|
73914184|NCT03000439|147357776|OTHER||Difference in LS Mean|0.29|||||TWO_SIDED|95.0|-0.43|1.0||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.00|-0.43|
73914185|NCT03000439|147357776|OTHER||Difference in LS Mean|1.01|||||TWO_SIDED|95.0|-0.06|2.08||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.08|-0.06|
73914186|NCT03000439|147357776|OTHER||Difference in LS Mean|1.25|||||TWO_SIDED|95.0|-1.13|3.64||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.64|-1.13|
73914187|NCT03000439|147357776|OTHER||Difference in LS Mean|0.1|||||TWO_SIDED|95.0|-0.68|0.88||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.88|-0.68|
73965627|NCT04238247|147467234|SUPERIORITY||Odds Ratio (OR)|7.959981|||<|0.001|TWO_SIDED|95.0|3.321933|19.07362|||Regression, Logistic|||||19.07362|3.321933|<0.001
74027026|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.0|||||TWO_SIDED|95.0|6.26|12.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||12.92|6.26|
73914188|NCT03000439|147357776|OTHER||Difference in LS Mean|-0.13|||||TWO_SIDED|95.0|-0.58|0.33||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.33|-0.58|
73914189|NCT03000439|147357776|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.03|0.68||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.68|-0.03|
74027027|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.5|||||TWO_SIDED|95.0|3.71|8.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.07|3.71|
74027028|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.2|||||TWO_SIDED|95.0|4.35|8.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.80|4.35|
73914190|NCT03000439|147357776|OTHER||Difference in LS Mean|-0.17|||||TWO_SIDED|95.0|-2.42|2.08||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.08|-2.42|
73914191|NCT03000439|147357776|OTHER||Difference in LS Mean|0.42|||||TWO_SIDED|95.0|-0.14|0.97||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.97|-0.14|
73914192|NCT03000439|147357776|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.15|0.79||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.79|-0.15|
73914193|NCT03000439|147357776|OTHER||Difference in LS Mean|0.68|||||TWO_SIDED|95.0|-0.14|1.49||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.49|-0.14|
73914194|NCT03000439|147357776|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-1.28|0.96||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.96|-1.28|
73914195|NCT03000439|147357776|OTHER||Difference in LS Mean|0.37|||||TWO_SIDED|95.0|-0.43|1.16||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.16|-0.43|
73914196|NCT03000439|147357776|OTHER||Difference in LS Mean|0.24|||||TWO_SIDED|95.0|-0.82|1.3||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-0.82|
73914197|NCT03000439|147357777|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.07|0.5||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.50|-0.07|
73914198|NCT03000439|147357777|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.15|0.32||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.32|-0.15|
73914199|NCT03000439|147357777|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-0.17|0.28||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.28|-0.17|
73914200|NCT03000439|147357777|OTHER||Difference in LS Mean|0.1|||||TWO_SIDED|95.0|-0.16|0.36||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.36|-0.16|
73914201|NCT03000439|147357777|OTHER||Difference in LS Mean|0.19|||||TWO_SIDED|95.0|-0.01|0.38||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.01|
73914202|NCT03000439|147357777|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-0.12|0.35||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.35|-0.12|
73914203|NCT03000439|147357777|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.18|0.31||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.31|-0.18|
73914204|NCT03000439|147357777|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.06|0.37||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.37|-0.06|
73914205|NCT03000439|147357777|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.14|0.36||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.36|-0.14|
73914206|NCT03000439|147357777|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.06|0.38||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.06|
73914207|NCT03000439|147357777|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.22|0.3||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.30|-0.22|
73914208|NCT03000439|147357777|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.2|0.38||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.20|
73914209|NCT03000439|147357777|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.24|0.42||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.42|-0.24|
73965628|NCT03092726|147467235|SUPERIORITY||LS Mean (LSM) Difference|0.06|STANDARD_ERROR_OF_MEAN|0.26||0.59|TWO_SIDED|90.0|-0.38|0.5||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Differences of least squares (LS) means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a mixed-effect, repeated measures (MMRM) model with change from baseline to each week from weeks 1 to 8 as response, treatment, center (pooled where necessary), time (study weeks 1 to 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||0.50|-0.38|0.590
73914210|NCT03000439|147357778|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.1|0.24||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.24|-0.10|
74085720|NCT01844531|147725645|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|104.61|STANDARD_ERROR_OF_MEAN|8.4||0|TWO_SIDED|90.0|99.882|109.555|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||109.555|99.882|0.0000
73859362|NCT02323204|147264614|OTHER|||||||0.7893|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7893
73914211|NCT03000439|147357778|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-0.19|0.15||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.15|-0.19|
73914212|NCT03000439|147357778|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-0.19|0.16||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.16|-0.19|
73914213|NCT03000439|147357778|OTHER||Difference in LS Mean|0.01|||||TWO_SIDED|95.0|-0.2|0.23||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.23|-0.20|
73914214|NCT03000439|147357778|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.02|0.32||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.32|-0.02|
73914215|NCT03000439|147357778|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.09|0.4||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.40|-0.09|
73914216|NCT03000439|147357778|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.16|0.34||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.34|-0.16|
73914217|NCT03000439|147357778|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.05|0.36||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.36|-0.05|
73914218|NCT03000439|147357778|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.1|0.43||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.43|-0.10|
73914219|NCT03000439|147357778|OTHER||Difference in LS Mean|0.17|||||TWO_SIDED|95.0|-0.06|0.39||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.39|-0.06|
73914220|NCT03000439|147357778|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.22|0.3||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.30|-0.22|
73859363|NCT02323204|147264614|OTHER|||||||0.2951|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2951
73914221|NCT03000439|147357778|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.18|0.49||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.49|-0.18|
73914222|NCT03000439|147357778|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.23|0.55||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.55|-0.23|
73914223|NCT03000439|147357779|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.97|1.4||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.40|-0.97|
73914224|NCT03000439|147357779|OTHER||Difference in LS Mean|0.58|||||TWO_SIDED|95.0|-0.68|1.84||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.84|-0.68|
73914225|NCT03000439|147357779|OTHER||Difference in LS Mean|1.2|||||TWO_SIDED|95.0|-0.77|3.16||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||3.16|-0.77|
73965629|NCT03092726|147467239|SUPERIORITY||Difference of percentages|-6.6||||0.874|TWO_SIDED|90.0|-18.7|5.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||5.7|-18.7|0.874
73965630|NCT03092726|147467239|SUPERIORITY||Differences of percentages|-5.6||||0.838|TWO_SIDED|90.0|-17.7|6.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||6.7|-17.7|0.838
73914226|NCT03000439|147357779|OTHER||Difference in LS Mean|-0.06|||||TWO_SIDED|95.0|-1.3|1.18||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.18|-1.30|
73965631|NCT03092726|147467240|SUPERIORITY||Differences of percentages|2.2||||0.412|TWO_SIDED|90.0|-10.0|14.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||14.4|-10.0|0.412
73914227|NCT03000439|147357779|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.29|0.82||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.82|-0.29|
73914228|NCT03000439|147357779|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.46|0.64||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.64|-0.46|
73914229|NCT03000439|147357779|OTHER||Difference in LS Mean|-0.46|||||TWO_SIDED|95.0|-2.05|1.13||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.13|-2.05|
73914230|NCT03000439|147357779|OTHER||Difference in LS Mean|0.35|||||TWO_SIDED|95.0|-0.18|0.88||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.18|
73914231|NCT03000439|147357779|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.26|0.88||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.26|
73914232|NCT03000439|147357779|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.43|0.99||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.99|-0.43|
73914233|NCT03000439|147357779|OTHER||Difference in LS Mean|0.29|||||TWO_SIDED|95.0|-0.45|1.03||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.03|-0.45|
73914234|NCT03000439|147357779|OTHER||Difference in LS Mean|0.22|||||TWO_SIDED|95.0|-0.63|1.08||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.08|-0.63|
73914235|NCT03000439|147357779|OTHER||Difference in LS Mean|0.45|||||TWO_SIDED|95.0|-0.66|1.57||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.57|-0.66|
73914236|NCT03000439|147357780|OTHER||Difference in LS Mean|-0.13|||||TWO_SIDED|95.0|-0.73|0.47||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.47|-0.73|
73914237|NCT03000439|147357780|OTHER||Difference in LS Mean|0.39|||||TWO_SIDED|95.0|-0.81|1.59||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.59|-0.81|
73914238|NCT03000439|147357780|OTHER||Difference in LS Mean|0.7|||||TWO_SIDED|95.0|-0.54|1.95||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.95|-0.54|
73914239|NCT03000439|147357780|OTHER||Difference in LS Mean|-0.4|||||TWO_SIDED|95.0|-0.9|0.1||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.10|-0.90|
73914240|NCT03000439|147357780|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.46|0.13||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.13|-0.46|
73914241|NCT03000439|147357780|OTHER||Difference in LS Mean|-0.32|||||TWO_SIDED|95.0|-0.63|-0.01||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.01|-0.63|
73965632|NCT03092726|147467240|SUPERIORITY||Differences of percentages|4.3||||0.269|TWO_SIDED|90.0|-7.9|16.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||16.4|-7.9|0.269
73914242|NCT03000439|147357780|OTHER||Difference in LS Mean|-1.09|||||TWO_SIDED|95.0|-2.34|0.15||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.15|-2.34|
73914243|NCT03000439|147357780|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.26|0.4||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.40|-0.26|
73914244|NCT03000439|147357780|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-0.3|0.26||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.26|-0.30|
73914245|NCT03000439|147357780|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.53|0.43||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.43|-0.53|
74085721|NCT01844531|147725645|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|104.53|STANDARD_ERROR_OF_MEAN|8.4|<|0.0001|TWO_SIDED|90.0|99.76|109.53|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||109.53|99.76|<.0001
73859364|NCT02323204|147264615|OTHER|||||||0.7166|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7166
74027029|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.6|||||TWO_SIDED|95.0|9.71|16.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.30|9.71|
74027030|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.5|||||TWO_SIDED|95.0|5.59|10.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.02|5.59|
73859365|NCT02323204|147264615|OTHER|||||||0.4501|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.4501
73859366|NCT02323204|147264616|OTHER|||||||0.6756|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.6756
73859367|NCT02323204|147264616|OTHER|||||||0.5381|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.5381
73859368|NCT02323204|147264617|OTHER|||||||0.1507|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.1507
73859369|NCT02323204|147264617|OTHER|||||||0.0769|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0769
73859370|NCT02323204|147264618|OTHER|||||||0.0654|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0654
73859371|NCT02323204|147264618|OTHER|||||||0.7957|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7957
73859372|NCT02323204|147264619|OTHER|||||||0.0286|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0286
73859373|NCT02323204|147264619|OTHER|||||||0.0201|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0201
73859374|NCT02323204|147264620|OTHER|||||||0.9928|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.9928
73859375|NCT02323204|147264620|OTHER|||||||0.0982|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0982
74085722|NCT01844531|147725645|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.96|STANDARD_ERROR_OF_MEAN|9.2||0|TWO_SIDED|90.0|97.917|108.258|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||108.258|97.917|0.0000
74088394|NCT01332578|147730217|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-20.92||||0.0004|TWO_SIDED|95.0|-27.31|-15.81|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of median difference was determined.|Null hypothesis was no difference between test hot drink and standard paracetamol tablets.||-15.81|-27.31|0.0004
73859376|NCT02323204|147264621|OTHER|||||||0.0325|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0325
73859377|NCT02323204|147264621|OTHER|||||||0.2568|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2568
73859378|NCT02323204|147264622|OTHER|||||||0.5824|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.5824
73859379|NCT02323204|147264622|OTHER|||||||0.4635|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.4635
73859380|NCT02323204|147264623|OTHER|||||||0.7949|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation over time between interventions was made through the intervention-time interaction effect included in the model. Significance in the interaction effect is indicative of a difference in the rate of change in implementation between interventions over time.||||0.7949
73859381|NCT02323204|147264623|OTHER|||||||0.0003|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation between interventions was made through the intervention main effect included in the model. The model at hand does not contain an interaction between intervention and time. Significance in the main intervention effect is indicative of a difference in implementation between intervention groups.||||0.0003
73859382|NCT00395135|147264624|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.6|||<|0.0001|TWO_SIDED|95.0|3.0|4.2|||ANCOVA|||||4.2|3.0|<0.0001
73859383|NCT00395135|147264626|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|-3.67|||<|0.001|TWO_SIDED|95.0|-4.09|-3.25|||ANCOVA|||||-3.25|-4.09|<0.001
73859384|NCT00395135|147264627|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.29|-1.88|||ANCOVA|||||-1.88|-3.29|<0.001
73859385|NCT00395135|147264627|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|1.64|||<|0.001|TWO_SIDED|95.0|1.1|2.19|||ANCOVA|||||2.19|1.10|<0.001
73859386|NCT04962230|147264646|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|specify in comments|56.82||||0.05|TWO_SIDED|90.0|47.04|68.62|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||68.62|47.04|0.05
73859387|NCT04962230|147264647|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|44.5||||0.05|TWO_SIDED|90.0|33.77|58.65|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||58.65|33.77|0.05
73859388|NCT04962230|147264648|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|25.59||||0.05|TWO_SIDED|90.0|18.76|34.91|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||34.91|18.76|0.05
73859389|NCT04962230|147264649|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|16.57||||0.05|TWO_SIDED|90.0|13.32|20.6|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||20.60|13.32|0.05
73859390|NCT04962230|147264655|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|44.59||||0.05|TWO_SIDED|90.0|33.99|58.5|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||58.50|33.99|0.05
73859391|NCT04962230|147264660|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|12.92||||0.05|TWO_SIDED|90.0|9.28|17.99|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||17.99|9.28|0.05
73859392|NCT01396265|147264664|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|66.2|STANDARD_DEVIATION|16.1|||TWO_SIDED|90.0|60.815|72.057|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||72.057|60.815|
73859393|NCT01396265|147264665|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|66.18|STANDARD_DEVIATION|16.5|||TWO_SIDED|90.0|60.656|72.213|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||72.213|60.656|
73965633|NCT03092726|147467241|SUPERIORITY||LSM Difference|-0.68|STANDARD_ERROR_OF_MEAN|2.03||0.369|TWO_SIDED|90.0|-4.05|2.68||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||2.68|-4.05|0.369
73859394|NCT01396265|147264666|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|78.41|STANDARD_DEVIATION|15.6|||TWO_SIDED|90.0|72.363|84.968|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||84.968|72.363|
73859395|NCT03831880|147264688|SUPERIORITY||Mean Difference (Final Values)|-15.49|||<|0.0001|TWO_SIDED|95.0|-19.71|-11.27||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-11.27|-19.71|<0.0001
73859396|NCT03831880|147264690|SUPERIORITY||Mean Difference (Final Values)|-5.39||||0.0017|TWO_SIDED|95.0|-8.69|-2.09||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-2.09|-8.69|0.0017
73859397|NCT03831880|147264692|SUPERIORITY||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-19.74|-7.45||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-7.45|-19.74|<0.0001
73859398|NCT03831880|147264694|SUPERIORITY||Mean Difference (Final Values)|-24.34|||<|0.0001|TWO_SIDED|95.0|-30.1|-18.57||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-18.57|-30.10|<0.0001
73859399|NCT03831880|147264696|SUPERIORITY||Mean Difference (Final Values)|-7.83||||0.0739|TWO_SIDED|95.0|-16.42|0.77||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||0.77|-16.42|0.0739
73859400|NCT03831880|147264698|SUPERIORITY||Mean Difference (Final Values)|-17.6|||<|0.0001|TWO_SIDED|95.0|-25.15|-10.06||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-10.06|-25.15|<0.0001
73859401|NCT03831880|147264700|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.6137|TWO_SIDED|95.0|-2.09|3.51||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||3.51|-2.09|0.6137
73859402|NCT03831880|147264702|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.8404|TWO_SIDED|95.0|-5.29|6.41||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||6.41|-5.29|0.8404
73859403|NCT03831880|147264704|SUPERIORITY||Mean Difference (Final Values)|-13.47|||<|0.0001|TWO_SIDED|95.0|-17.59|-9.35||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-9.35|-17.59|<0.0001
73859404|NCT03831880|147264706|SUPERIORITY||Mean Difference (Final Values)|-2.76||||0.0245|TWO_SIDED|95.0|-5.16|-0.36||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-0.36|-5.16|0.0245
73859405|NCT03831880|147264718|SUPERIORITY||Mean Difference (Final Values)|-14.58|||<|0.0001|TWO_SIDED|95.0|-18.72|-10.44||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-10.44|-18.72|<0.0001
73859406|NCT02081638|147264725|OTHER||||||>|0.05||||||Threshold for statistical significance was a priori set to \<0.05|Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||>0.05
73859407|NCT02081638|147264725|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.022
73859408|NCT02081638|147264726|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.13
73914246|NCT03000439|147357780|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.56|0.46||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.46|-0.56|
73914247|NCT03000439|147357780|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-0.74|0.69||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.74|
73859409|NCT02081638|147264726|OTHER|||||||0.097|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.097
73859410|NCT02081638|147264726|OTHER|||||||0.0269|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.0269
73859411|NCT02081638|147264726|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
73859412|NCT02081638|147264726|OTHER||||||||||||||||||Plasma biomarkers (CRP, sCD14, TF, IL-6) were log(e) transformed and a linear mixed effect model with the biomarker as outcome and with random slope per participant was used to calculate the percentage of change from baseline.|||
73859413|NCT04346108|147264746|SUPERIORITY||Poisson Estimate|1.65|||||TWO_SIDED|95.0|0.73|3.15||||||||3.15|0.73|
73965634|NCT03092726|147467241|SUPERIORITY||LSM Difference|-0.64|STANDARD_ERROR_OF_MEAN|2.34||0.393|TWO_SIDED|90.0|-4.51|3.24||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||3.24|-4.51|0.393
73965635|NCT03092726|147467241|SUPERIORITY||LSM Difference|0.86|STANDARD_ERROR_OF_MEAN|2.68||0.626|TWO_SIDED|90.0|-3.57|5.3|||MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||5.30|-3.57|0.626
74088395|NCT00934596|147730225|SUPERIORITY_OR_OTHER||Median Difference (Net)|57.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
73965636|NCT03092726|147467241|SUPERIORITY||LSM Difference|1.09|STANDARD_ERROR_OF_MEAN|2.57||0.664|TWO_SIDED|90.0|-3.16|5.34||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||5.34|-3.16|0.664
74027031|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|15.1|||||TWO_SIDED|95.0|9.56|23.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||23.81|9.56|
74027032|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.3|||||TWO_SIDED|95.0|8.66|17.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||17.38|8.66|
74027033|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.5|||||TWO_SIDED|95.0|4.29|9.89|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.89|4.29|
74027034|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|20.8|||||TWO_SIDED|95.0|12.59|34.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||34.24|12.59|
74027035|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|21.4|||||TWO_SIDED|95.0|14.56|31.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||31.46|14.56|
73859414|NCT04346108|147264746|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
73859415|NCT04346108|147264746|SUPERIORITY||Poisson Estimate|2.48|||||TWO_SIDED|95.0|1.34|4.13||||||||4.13|1.34|
73859416|NCT04346108|147264747|SUPERIORITY||Poisson Estimate|2.6|||||TWO_SIDED|95.0|1.02|5.3||||||||5.30|1.02|
73859417|NCT04346108|147264747|SUPERIORITY||Poisson Estimate|9.82|||||TWO_SIDED|95.0|2.82|23.82||||||||23.82|2.82|
73859418|NCT04346108|147264747|SUPERIORITY||Poisson Estimate|2.87|||||TWO_SIDED|95.0|1.37|5.18||||||||5.18|1.37|
73859419|NCT04346108|147264748|SUPERIORITY||Poisson Estimate|4.01||||||95.0|1.46|8.54||||||||8.54|1.46|
73859420|NCT04346108|147264748|SUPERIORITY||Poisson Estimate|3.07|||||TWO_SIDED|95.0|0.37|10.74||||||||10.74|0.37|
73859421|NCT04346108|147264748|SUPERIORITY||Poisson Estimate|5.87|||||TWO_SIDED|95.0|2.32|11.93||||||||11.93|2.32|
73859422|NCT04346108|147264749|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
73859423|NCT04346108|147264749|SUPERIORITY||Poisson Estimate|0.13|||||TWO_SIDED|95.0|0.03|0.35||||||||0.35|0.03|
73859424|NCT04346108|147264749|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
73859425|NCT04346108|147264750|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
73859426|NCT04346108|147264750|SUPERIORITY||Poisson Estimate|1.04|||||TWO_SIDED|95.0|0.25|2.76||||||||2.76|0.25|
73859427|NCT04346108|147264751|SUPERIORITY||Poisson Estimate|1.18|||||TWO_SIDED|95.0|0.38|2.68||||||||2.68|0.38|
73859428|NCT04346108|147264751|SUPERIORITY||Poisson Estimate|2.35|||||TWO_SIDED|95.0|0.91|4.82||||||||4.82|0.91|
73859429|NCT04346108|147264751|SUPERIORITY||Poisson Estimate|0.61|||||TWO_SIDED|95.0|0.07|2.15||||||||2.15|0.07|
73859430|NCT01852825|147264765|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.355||||0.003|TWO_SIDED|90.0|1.515|3.661|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is \>1.0.||3.661|1.515|0.003
73859431|NCT01852825|147264766|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.182||||0.01|TWO_SIDED|90.0|1.364|3.49|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is \>1.0.||3.490|1.364|0.010
73859432|NCT01852825|147264767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.027|TWO_SIDED|90.0|0.066|0.41|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment|The hypothesis is supported if the lower bound of the 1-tailed 95% CI around the mean difference in change from baseline excludes zero||0.410|0.066|0.027
73859433|NCT01852825|147264768|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.068||||0.935|TWO_SIDED|90.0|0.272|4.19|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|||4.190|0.272|0.935
73859434|NCT01852825|147264769|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.21||||0.296|TWO_SIDED|90.0|0.605|8.066|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|||8.066|0.605|0.296
73914248|NCT03000439|147357780|OTHER||Difference in LS Mean|0.2|||||TWO_SIDED|95.0|-0.91|1.32||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.32|-0.91|
73914249|NCT03000439|147357781|OTHER||Difference in LS Mean|1.01|||||TWO_SIDED|95.0|0.09|1.92||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.92|0.09|
73914250|NCT03000439|147357781|OTHER||Difference in LS Mean|1.31|||||TWO_SIDED|95.0|0.4|2.22||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||2.22|0.40|
73914251|NCT03000439|147357781|OTHER||Difference in LS Mean|0.53|||||TWO_SIDED|95.0|-0.47|1.53||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.53|-0.47|
73914252|NCT03000439|147357781|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.63|1.16||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.16|-0.63|
73914253|NCT03000439|147357781|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.33|0.97||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.97|-0.33|
73914254|NCT03000439|147357781|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.1|1.2||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.20|-0.10|
73914255|NCT03000439|147357781|OTHER||Difference in LS Mean|0.2|||||TWO_SIDED|95.0|-0.93|1.33||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.33|-0.93|
73914256|NCT03000439|147357781|OTHER||Difference in LS Mean|0.62|||||TWO_SIDED|95.0|-0.17|1.42||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.42|-0.17|
73914257|NCT03000439|147357781|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.02|0.98||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.98|-0.02|
73914258|NCT03000439|147357781|OTHER||Difference in LS Mean|0.64|||||TWO_SIDED|95.0|-0.3|1.58||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.58|-0.30|
73914259|NCT03000439|147357781|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.4|0.85||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.85|-0.40|
73914260|NCT03000439|147357781|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.36|0.88||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.36|
73914261|NCT03000439|147357781|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.87|1.09||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.09|-0.87|
73914262|NCT03000439|147357782|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.77|0.67||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.67|-0.77|
73914263|NCT03000439|147357782|OTHER||Difference in LS Mean|0.58|||||TWO_SIDED|95.0|-0.37|1.53||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.53|-0.37|
73914264|NCT03000439|147357782|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-1.06|1.3||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-1.06|
73914265|NCT03000439|147357782|OTHER||Difference in LS Mean|-0.26|||||TWO_SIDED|95.0|-1.27|0.74||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.74|-1.27|
73914266|NCT03000439|147357782|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.83|0.52||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.52|-0.83|
73914267|NCT03000439|147357782|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-0.61|0.71||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.71|-0.61|
73914268|NCT03000439|147357782|OTHER||Difference in LS Mean|-0.1|||||TWO_SIDED|95.0|-1.45|1.25||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.25|-1.45|
73914269|NCT03000439|147357782|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.61|1.23||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.23|-0.61|
73914270|NCT03000439|147357782|OTHER||Difference in LS Mean|0.18|||||TWO_SIDED|95.0|-0.34|0.71||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.71|-0.34|
73914271|NCT03000439|147357782|OTHER||Difference in LS Mean|0.36|||||TWO_SIDED|95.0|-0.74|1.46||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.46|-0.74|
73914272|NCT03000439|147357782|OTHER||Difference in LS Mean|-0.09|||||TWO_SIDED|95.0|-0.75|0.56||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.56|-0.75|
73914273|NCT03000439|147357782|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.68|0.81||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.81|-0.68|
73914274|NCT03000439|147357782|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.1|0.94||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.94|-1.10|
73914275|NCT03000439|147357783|OTHER||Difference in LS Mean|-1.46|||||TWO_SIDED|95.0|-14.59|11.66||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||11.66|-14.59|
73914276|NCT03000439|147357783|OTHER||Difference in LS Mean|-7.22|||||TWO_SIDED|95.0|-19.62|5.17||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||5.17|-19.62|
73914277|NCT03000439|147357783|OTHER||Difference in LS Mean|-6.61|||||TWO_SIDED|95.0|-19.36|6.14||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||6.14|-19.36|
73914278|NCT03000439|147357783|OTHER||Difference in LS Mean|-8.5|||||TWO_SIDED|95.0|-20.28|3.27||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||3.27|-20.28|
74085723|NCT01844531|147725645|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.8|STANDARD_ERROR_OF_MEAN|9.2|<|0.0001|TWO_SIDED|90.0|97.72|108.14|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||108.14|97.72|<.0001
74088396|NCT00934596|147730228|SUPERIORITY_OR_OTHER||Median Difference (Net)|72.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73914279|NCT03000439|147357783|OTHER||Difference in LS Mean|-3.95|||||TWO_SIDED|95.0|-10.53|2.62||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.62|-10.53|
73914280|NCT03000439|147357783|OTHER||Difference in LS Mean|-1.44|||||TWO_SIDED|95.0|-8.09|5.21||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||5.21|-8.09|
73914281|NCT03000439|147357783|OTHER||Difference in LS Mean|-4.32|||||TWO_SIDED|95.0|-16.67|8.03||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.03|-16.67|
73914282|NCT03000439|147357783|OTHER||Difference in LS Mean|-2.86|||||TWO_SIDED|95.0|-13.97|8.25||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.25|-13.97|
73914283|NCT03000439|147357783|OTHER||Difference in LS Mean|-10.95|||||TWO_SIDED|95.0|-24.63|2.73||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.73|-24.63|
73914284|NCT03000439|147357783|OTHER||Difference in LS Mean|-4.28|||||TWO_SIDED|95.0|-16.74|8.18||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.18|-16.74|
73914285|NCT03000439|147357783|OTHER||Difference in LS Mean|-8.32|||||TWO_SIDED|95.0|-15.2|-1.43||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||-1.43|-15.20|
73914286|NCT03000439|147357783|OTHER||Difference in LS Mean|-4.84|||||TWO_SIDED|95.0|-12.6|2.92||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.92|-12.60|
73914287|NCT03000439|147357783|OTHER||Difference in LS Mean|-1.34|||||TWO_SIDED|95.0|-5.16|2.48||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.48|-5.16|
73914288|NCT03000439|147357784|OTHER||Difference in LS Mean|-6.05|||||TWO_SIDED|95.0|-16.3|4.19||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.19|-16.30|
73914289|NCT03000439|147357784|OTHER||Difference in LS Mean|-10.46|||||TWO_SIDED|95.0|-21.68|0.77||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.77|-21.68|
73914290|NCT03000439|147357784|OTHER||Difference in LS Mean|-10.86|||||TWO_SIDED|95.0|-23.75|2.03||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.03|-23.75|
73965637|NCT03092726|147467242|SUPERIORITY||LSM Difference|0.16|STANDARD_ERROR_OF_MEAN|1.85||0.534|TWO_SIDED|90.0|-2.9|3.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||3.22|-2.90|0.534
73965638|NCT03092726|147467242|SUPERIORITY||LSM Difference|1.46|STANDARD_ERROR_OF_MEAN|2.08||0.758|TWO_SIDED|90.0|-1.98|4.91||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||4.91|-1.98|0.758
73965639|NCT03092726|147467242|SUPERIORITY||LSM Difference|1.7|STANDARD_ERROR_OF_MEAN|2.57||0.745|TWO_SIDED|90.0|-2.56|5.96||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||5.96|-2.56|0.745
73965640|NCT03092726|147467242|SUPERIORITY||LSM Difference|1.68|STANDARD_ERROR_OF_MEAN|2.43||0.755|TWO_SIDED|90.0|-2.34|5.69||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||5.69|-2.34|0.755
73965641|NCT03092726|147467243|SUPERIORITY||LSM Difference|0.19|STANDARD_ERROR_OF_MEAN|0.59||0.629|TWO_SIDED|90.0|-0.78|1.17||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.17|-0.78|0.629
73965642|NCT03092726|147467243|SUPERIORITY||LSM Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.73||0.41|TWO_SIDED|90.0|-1.37|1.04||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.04|-1.37|0.410
73965643|NCT03092726|147467243|SUPERIORITY||LSM Difference|0.06|STANDARD_ERROR_OF_MEAN|0.71||0.531|TWO_SIDED|90.0|-1.11|1.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.22|-1.11|0.531
74027036|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|7.24|17.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||17.01|7.24|
74027037|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|32.2|||||TWO_SIDED|95.0|19.75|52.57|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||52.57|19.75|
74027038|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|47.2|||||TWO_SIDED|95.0|34.0|65.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||65.43|34.00|
74027039|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|19.4|||||TWO_SIDED|95.0|12.95|29.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||29.17|12.95|
74088397|NCT00934596|147730233|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||As data for these small groups were non-parametric the median and quartiles were used for comparison of groups by the Wilcoxon Rank Sum test.||||<0.001
73859435|NCT01852825|147264770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.115||||0.014|TWO_SIDED|90.0|-100.185|-22.045|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment|||-22.045|-100.185|0.014
73859436|NCT02159118|147264771|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73859437|NCT02159118|147264772|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
73859438|NCT02159118|147264773|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73859439|NCT02159118|147264774|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73859440|NCT02159118|147264775|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
73859441|NCT02159118|147264776|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||||||0.93
73859442|NCT02159118|147264777|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
73859443|NCT02159118|147264778|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
73859444|NCT02159118|147264779|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
73859445|NCT01327274|147264782|OTHER|Pre-treatment and post-treatment Pectus Severity Indices were compared using the Wilcoxon matched-pairs signed rank test.||||||0.486|||||||Wilcoxon (Mann-Whitney)|||||||0.486
73859446|NCT01865812|147264794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.51|-0.24||||||||-0.24|-0.51|
73859447|NCT01865812|147264795|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44|||||TWO_SIDED|95.0|-0.63|-0.25||||||||-0.25|-0.63|
73859448|NCT01865812|147264796|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-1.58|1.46||||||||1.46|-1.58|
73859449|NCT01865812|147264847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.852|||||||ANCOVA|||||||0.852
73859450|NCT01865812|147264848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.549|||||||ANCOVA|||||||0.549
73859451|NCT01865812|147264849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.912|||||||ANCOVA|||||||0.912
73859452|NCT01095653|147264851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.0975|<|0.0001|TWO_SIDED|95.0|-0.94|-0.56||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.56|-0.94|<0.0001
73859453|NCT01095653|147264851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.0962|<|0.0001|TWO_SIDED|95.0|-1.01|-0.63||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.63|-1.01|<0.0001
73859454|NCT01095653|147264852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.7|STANDARD_ERROR_OF_MEAN|3.203|<|0.0001|TWO_SIDED|95.0|-34.0|-21.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-21.4|-34.0|<0.0001
73859455|NCT01095653|147264852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.2|STANDARD_ERROR_OF_MEAN|3.174|<|0.0001|TWO_SIDED|95.0|-40.4|-27.9||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-27.9|-40.4|<0.0001
73859456|NCT01095653|147264853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.9|STANDARD_ERROR_OF_MEAN|6.5667|<|0.0001|TWO_SIDED|95.0|-60.8|-34.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-34.96|-60.80|<0.0001
73859457|NCT01095653|147264853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.0|STANDARD_ERROR_OF_MEAN|6.4489|<|0.0001|TWO_SIDED|95.0|-68.66|-43.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-43.28|-68.66|<0.0001
73859458|NCT01095653|147264854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3259|<|0.0001|TWO_SIDED|95.0|-2.01|-0.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.73|-2.01|<0.0001
73859459|NCT01095653|147264854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.3242|<|0.0001|TWO_SIDED|95.0|-2.62|-1.34||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-1.34|-2.62|<0.0001
73859460|NCT01095653|147264855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.3|STANDARD_ERROR_OF_MEAN|5.238|<|0.0001|TWO_SIDED|95.0|11.1|31.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||31.6|11.1|<0.0001
73859461|NCT01095653|147264855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5|STANDARD_ERROR_OF_MEAN|5.022|<|0.0001|TWO_SIDED|95.0|18.6|38.3||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||38.3|18.6|<0.0001
73859462|NCT03373890|147264877|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
73965644|NCT03092726|147467243|SUPERIORITY||LSM Difference|0.17|STANDARD_ERROR_OF_MEAN|0.67||0.603|TWO_SIDED|90.0|-0.93|1.28||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||1.28|-0.93|0.603
73965645|NCT03092726|147467244|SUPERIORITY||Odds Ratio (OR)|1.07||||0.811|TWO_SIDED|90.0|0.68|1.67||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 2: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.67|0.68|0.811
73965646|NCT03092726|147467244|SUPERIORITY||Odds Ratio (OR)|0.79||||0.368|TWO_SIDED|90.0|0.5|1.22||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 4: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.22|0.50|0.368
73859463|NCT03373890|147264878|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
73859464|NCT03373890|147264879|OTHER|Independent samples Mann Whitney U||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||.03
73859465|NCT03373890|147264880|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
73859466|NCT03373890|147264881|OTHER|Independent samples Mann Whitney U||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
73859467|NCT03373890|147264882|OTHER|Independent samples Mann Whitney U||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||.99
73859468|NCT03373890|147264883|OTHER|LInear mixed model||||||0.008|||||||Regression, Logistic|||||||.008
73859469|NCT03373890|147264884|OTHER|Linear mixed model regression||||||0.34|||||||Regression, Linear|||||||.34
73859470|NCT02210221|147264890|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in 6-month mortality||||<0.0001
73859471|NCT02210221|147264890|OTHER||observed to expected ratio|0.7|||||TWO_SIDED|95.0|0.62|0.76|||||numerator: 6-month mortality observed denominator: 6-month mortality expected 95% CIs estimated according to a Poisson distribution|||0.76|0.62|
73859472|NCT02210221|147264891|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 mental component summary||||<0.0001
74085724|NCT01844531|147725646|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|94.76|STANDARD_ERROR_OF_MEAN|11.4||0.0001|TWO_SIDED|90.0|89.056|100.819|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.819|89.056|0.0001
74085725|NCT01844531|147725646|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|94.4|STANDARD_ERROR_OF_MEAN|11.4||0.0001|TWO_SIDED|90.0|88.64|100.54|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.54|88.64|0.0001
73914291|NCT03000439|147357784|OTHER||Difference in LS Mean|-13.15|||||TWO_SIDED|95.0|-25.83|-0.46||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.46|-25.83|
73914292|NCT03000439|147357784|OTHER||Difference in LS Mean|-7.02|||||TWO_SIDED|95.0|-13.56|-0.47||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.47|-13.56|
73914293|NCT03000439|147357784|OTHER||Difference in LS Mean|-4.53|||||TWO_SIDED|95.0|-11.0|1.95||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.95|-11.00|
73965647|NCT03092726|147467244|SUPERIORITY||Odds Ratio (OR)|0.78||||0.357|TWO_SIDED|90.0|0.5|1.21||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 8: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.21|0.50|0.357
73914294|NCT03000439|147357784|OTHER||Difference in LS Mean|-9.35|||||TWO_SIDED|95.0|-22.24|3.54||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.54|-22.24|
73914295|NCT03000439|147357784|OTHER||Difference in LS Mean|-6.75|||||TWO_SIDED|95.0|-18.34|4.83||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.83|-18.34|
73914296|NCT03000439|147357784|OTHER||Difference in LS Mean|-15.49|||||TWO_SIDED|95.0|-30.36|-0.63||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.63|-30.36|
73914297|NCT03000439|147357784|OTHER||Difference in LS Mean|-7.99|||||TWO_SIDED|95.0|-21.0|5.03||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.03|-21.00|
73914298|NCT03000439|147357784|OTHER||Difference in LS Mean|-10.49|||||TWO_SIDED|95.0|-17.67|-3.31||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-3.31|-17.67|
73914299|NCT03000439|147357784|OTHER||Difference in LS Mean|-5.93|||||TWO_SIDED|95.0|-13.53|1.67||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.67|-13.53|
73914300|NCT03000439|147357784|OTHER||Difference in LS Mean|-2.57|||||TWO_SIDED|95.0|-6.37|1.24||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.24|-6.37|
74085726|NCT01844531|147725646|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|93.83|STANDARD_ERROR_OF_MEAN|11.9||0.0002|TWO_SIDED|90.0|88.006|100.034|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.034|88.006|0.0002
74085727|NCT01844531|147725646|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|93.98|STANDARD_ERROR_OF_MEAN|12.0||0.0003|TWO_SIDED|90.0|87.94|100.43|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.43|87.94|0.0003
74085728|NCT01844531|147725647|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|95.78|STANDARD_ERROR_OF_MEAN|15.7||0.0008|TWO_SIDED|90.0|88.0|104.256|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||104.256|88.000|0.0008
73914301|NCT03000439|147357785|OTHER||Difference in LS Mean|0.51|||||TWO_SIDED|95.0|0.2|2.22||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.22|0.20|
73914302|NCT03000439|147357785|OTHER||Difference in LS Mean|0.82|||||TWO_SIDED|95.0|-0.2|1.85||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.85|-0.20|
73914303|NCT03000439|147357785|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.65|1.27||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.27|-0.65|
74085729|NCT01844531|147725647|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.74|STANDARD_ERROR_OF_MEAN|15.5||0.0006|TWO_SIDED|90.0|88.78|105.41|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||105.41|88.78|0.0006
74085730|NCT01844531|147725647|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|95.94|STANDARD_ERROR_OF_MEAN|9.3||0|TWO_SIDED|90.0|91.199|100.934|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||100.934|91.199|0.0000
74085731|NCT01844531|147725647|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.1|STANDARD_ERROR_OF_MEAN|9.3|<|0.0001|TWO_SIDED|90.0|91.28|101.19|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||101.19|91.28|<.0001
74085732|NCT04894084|147725649|SUPERIORITY||Risk Ratio (RR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.49|||Poisson loglinear model|||||0.49|0.07|<0.001
74085733|NCT04894084|147725650|OTHER||Exact test in the binomial distribution|91.3|||<|0.0001|TWO_SIDED|95.0|72.0|99.0||"Low degree + Very low degree / Not at all were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."||99|72|<0.0001
74085734|NCT04894084|147725651|OTHER||Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0||"Some degree, High degree and Very high degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For reliability answered on a 5-point scale the answers some, high, or very high degree was considered acceptable and grouped against answers of 'low or very low' degree of reliability.||93|56|0.0106
74085735|NCT04894084|147725652|OTHER||Exact test in the binomial distribution|95.7|||<|0.0001|TWO_SIDED|95.0|78.0|100.0||"Same, Better and Much better were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. For ability to move with test product it was tested if the proportion evaluating same or better was significantly different from 50% when using a 5% test level. The answers of 'same, better or much better' was grouped against the answers of 'worse or much worse' ability to move.||100|78|<0.0001
74085736|NCT04894084|147725653|OTHER|Users worry of leakage given on a 5-point scale was analyzed by a proportional odds ratio model taken the paired design into consideration to compare the results from V1 and V2.|||||<|0.001|||||||Proportional odds ratio model|||||||<0.001
74085737|NCT04894084|147725654|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0|||Exact test in the binomial distribution|||||93|56|0.0106
74085738|NCT04894084|147725655|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|65.2||||0.21|TWO_SIDED|95.0|43.0|84.0||"Higher degree and Much higher degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||84|43|0.21
74085739|NCT04894084|147725656|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0|||Exact test in the binomial distribution|||||93|56|0.0106
73914304|NCT03000439|147357785|OTHER||Difference in LS Mean|0.57|||||TWO_SIDED|95.0|-0.26|1.41||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.41|-0.26|
73914305|NCT03000439|147357785|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.78|1.1||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.10|-0.78|
73914306|NCT03000439|147357785|OTHER||Difference in LS Mean|0.66|||||TWO_SIDED|95.0|-0.18|1.49||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.49|-0.18|
73914307|NCT03000439|147357785|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.43|1.27||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.27|-1.43|
73914308|NCT03000439|147357785|OTHER||Difference in LS Mean|-0.07|||||TWO_SIDED|95.0|-0.65|0.5||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.50|-0.65|
73914309|NCT03000439|147357785|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.51|0.63||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.63|-0.51|
73914310|NCT03000439|147357785|OTHER||Difference in LS Mean|-0.04|||||TWO_SIDED|95.0|-0.55|0.47||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.47|-0.55|
73914311|NCT03000439|147357785|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.82|0.5||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.50|-0.82|
73914312|NCT03000439|147357785|OTHER||Difference in LS Mean|-0.14|||||TWO_SIDED|95.0|-1.51|1.22||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.22|-1.51|
73914313|NCT03000439|147357785|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.05|0.88||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.88|-1.05|
73914314|NCT03000439|147357786|OTHER||Difference in LS Mean|0.49|||||TWO_SIDED|95.0|-0.32|1.3||||||DB at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-0.32|
73914315|NCT03000439|147357786|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.64|1.61||||||DB at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.61|-0.64|
73914316|NCT03000439|147357786|OTHER||Difference in LS Mean|0.03|||||TWO_SIDED|95.0|-1.02|1.07||||||DB at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.07|-1.02|
73914317|NCT03000439|147357786|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.69|1.14||||||DB at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.14|-0.69|
73914318|NCT03000439|147357786|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-1.05|1.22||||||DB at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.22|-1.05|
73914319|NCT03000439|147357786|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.6|1.16||||||DB at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.16|-0.60|
73914320|NCT03000439|147357786|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-1.6|1.64||||||DB at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.64|-1.60|
73914321|NCT03000439|147357786|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-1.6|1.64||||||DB at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.64|-1.60|
73914322|NCT03000439|147357786|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.58|0.73||||||DB at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.73|-0.58|
73914323|NCT03000439|147357786|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.53|0.65||||||DB at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.65|-0.53|
73914324|NCT03000439|147357786|OTHER||Difference in LS Mean|-0.12|||||TWO_SIDED|95.0|-0.87|0.64||||||DB at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.64|-0.87|
73914325|NCT03000439|147357786|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-1.13|1.54||||||DB at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.54|-1.13|
73914326|NCT03000439|147357786|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-1.0|1.11||||||DB at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.11|-1.00|
73914327|NCT03000439|147357789|OTHER||Difference in LS Mean|6.0|||||TWO_SIDED|95.0|-8.35|20.36||||||CHQ01-Global Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||20.36|-8.35|
73914328|NCT03000439|147357789|OTHER||Difference in LS Mean|2.85|||||TWO_SIDED|95.0|-12.43|18.14||||||CHQ01-Global Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.14|-12.43|
73914329|NCT03000439|147357789|OTHER||Difference in LS Mean|-4.19|||||TWO_SIDED|95.0|-15.78|7.4||||||CHQ01-Physical Functioning Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||7.40|-15.78|
73914330|NCT03000439|147357789|OTHER||Difference in LS Mean|2.31|||||TWO_SIDED|95.0|-37.06|41.68||||||CHQ01-Physical Functioning Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||41.68|-37.06|
73914331|NCT03000439|147357789|OTHER||Difference in LS Mean|-5.47|||||TWO_SIDED|95.0|-17.37|6.43||||||CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.43|-17.37|
73914332|NCT03000439|147357789|OTHER||Difference in LS Mean|6.82|||||TWO_SIDED|95.0|-20.92|34.57||||||CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||34.57|-20.92|
74085740|NCT04894084|147725657|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|69.6||||0.093|TWO_SIDED|95.0|47.0|87.0|||Exact test in the binomial distribution|||||87|47|0.093
74085741|NCT04894084|147725658|OTHER|By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion with a positive response was significantly different from 50% when using a 5% test level.|Exact test in the binomial distribution|95.7|||<|0.0001|TWO_SIDED|95.0|78.0|100.0|||Exact test in the binomial distribution|||||100|78|<0.0001
74085742|NCT04894084|147725659|OTHER|By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion answering I felt more confident was significantly different from 50% when using a 5% test level.|Exact test in the binomial distribution|91.3|||<|0.0001|TWO_SIDED|95.0|72.0|99.0|||Exact test in the binomial distribution|||||99|72|<0.0001
74085743|NCT04894084|147725660|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|34.8||||0.21|TWO_SIDED|95.0|16.0|57.0||"Yes, to the better was tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||57|16|0.21
74085744|NCT04894084|147725661|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|47.8||||1|TWO_SIDED|95.0|27.0|69.0||"Higher degree and Much higher degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||69|27|1.00
73859473|NCT02210221|147264891|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 physical component summary||||<0.0001
73859474|NCT02210221|147264892|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in Qolibri Overall Scale||||<0.0001
73859475|NCT02210221|147264893|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
73859476|NCT02210221|147264894|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
73859477|NCT02210221|147264895|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
73859478|NCT02210221|147264896|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
73859479|NCT02210221|147264897|NON_INFERIORITY|non-inferiority margin = 0||||||0.169|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.169
73859480|NCT02210221|147264898|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||Fisher Exact|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
73859481|NCT02210221|147264899|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
73859482|NCT02210221|147264900|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
73859483|NCT02210221|147264901|NON_INFERIORITY|non-inferiority margin = 0||||||0.637|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.637
73859484|NCT02210221|147264902|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
73859485|NCT02210221|147264903|NON_INFERIORITY|non-inferiority margin = 0||||||0.48|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.480
73859486|NCT02210221|147264904|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
73859487|NCT02210221|147264905|NON_INFERIORITY|non-inferiority margin = 0||||||0.024|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.024
73859488|NCT02210221|147264906|NON_INFERIORITY|non-inferiority margin = 0||||||0.064|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.064
73859489|NCT02210221|147264907|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
73859490|NCT02230761|147264908|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.020
73859491|NCT02230761|147264909|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
73859492|NCT02230761|147264910|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
73859493|NCT02863523|147264918|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73859494|NCT02863523|147264919|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
73859495|NCT02863523|147264920|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73914333|NCT03000439|147357789|OTHER||Difference in LS Mean|-6.22|||||TWO_SIDED|95.0|-18.95|6.5||||||CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.50|-18.95|
73914334|NCT03000439|147357789|OTHER||Difference in LS Mean|11.09|||||TWO_SIDED|95.0|-46.24|68.42||||||CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||68.42|-46.24|
73914335|NCT03000439|147357789|OTHER||Difference in LS Mean|-1.45|||||TWO_SIDED|95.0|-13.97|11.06||||||CHQ01-Bodily Pain Subscale Standardized Score: DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||11.06|-13.97|
73914336|NCT03000439|147357789|OTHER||Difference in LS Mean|17.2|||||TWO_SIDED|95.0|-28.01|62.41||||||CHQ01-Bodily Pain Subscale Standardized Score: DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||62.41|-28.01|
73914337|NCT03000439|147357789|OTHER||Difference in LS Mean|-5.15|||||TWO_SIDED|95.0|-13.24|2.93||||||CHQ01-Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.93|-13.24|
73914338|NCT03000439|147357789|OTHER||Difference in LS Mean|-15.03|||||TWO_SIDED|95.0|-33.12|3.06||||||CHQ01-Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.06|-33.12|
73914339|NCT03000439|147357789|OTHER||Difference in LS Mean|-5.32|||||TWO_SIDED|95.0|-16.92|6.29||||||CHQ01-Global Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.29|-16.92|
73914340|NCT03000439|147357789|OTHER||Difference in LS Mean|-7.24|||||TWO_SIDED|95.0|-20.35|5.87||||||CHQ01-Global Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.87|-20.35|
73914341|NCT03000439|147357789|OTHER||Difference in LS Mean|4.44|||||TWO_SIDED|95.0|-6.18|15.07||||||CHQ01-Mental Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||15.07|-6.18|
73914342|NCT03000439|147357789|OTHER||Difference in LS Mean|-7.46|||||TWO_SIDED|95.0|-24.37|9.45||||||CHQ01-Mental Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||9.45|-24.37|
73914343|NCT03000439|147357789|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-9.14|9.13||||||CHQ01-Self Esteem Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||9.13|-9.14|
73914344|NCT03000439|147357789|OTHER||Difference in LS Mean|-7.59|||||TWO_SIDED|95.0|-33.87|18.7||||||CHQ01-Self Esteem Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.70|-33.87|
73914345|NCT03000439|147357789|OTHER||Difference in LS Mean|4.98|||||TWO_SIDED|95.0|-4.81|14.77||||||CHQ01-General Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||14.77|-4.81|
73914346|NCT03000439|147357789|OTHER||Difference in LS Mean|-1.02|||||TWO_SIDED|95.0|-20.31|18.28||||||CHQ01-General Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.28|-20.31|
73914347|NCT03000439|147357789|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-0.4|0.33||||||CHQ01-Change in Health Subscale Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.33|-0.40|
73914348|NCT03000439|147357789|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.68|1.65||||||CHQ01-Change in Health Subscale Score; DB Week48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.65|-0.68|
73914349|NCT03000439|147357789|OTHER||Difference in LS Mean|2.25|||||TWO_SIDED|95.0|-10.59|15.1||||||CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||15.10|-10.59|
73914350|NCT03000439|147357789|OTHER||Difference in LS Mean|-25.07|||||TWO_SIDED|95.0|-60.96|10.82||||||CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||10.82|-60.96|
73914351|NCT03000439|147357789|OTHER||Difference in LS Mean|1.87|||||TWO_SIDED|95.0|-13.55|17.29||||||CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||17.29|-13.55|
73965648|NCT03092726|147467244|SUPERIORITY||Odds Ratio (OR)|0.8||||0.407|TWO_SIDED|90.0|0.52|1.24||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||EOT: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.24|0.52|0.407
74027040|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.8|||||TWO_SIDED|95.0|7.79|21.13|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||21.13|7.79|
73914352|NCT03000439|147357789|OTHER||Difference in LS Mean|-9.19|||||TWO_SIDED|95.0|-48.91|30.53||||||CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||30.53|-48.91|
73914353|NCT03000439|147357789|OTHER||Difference in LS Mean|-3.97|||||TWO_SIDED|95.0|-12.84|4.9||||||CHQ01-Family Activities Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.90|-12.84|
74027041|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.6|||||TWO_SIDED|95.0|8.56|18.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.68|8.56|
74027042|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.8|||||TWO_SIDED|95.0|4.54|10.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.10|4.54|
74027043|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.8|||||TWO_SIDED|95.0|8.16|20.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||20.02|8.16|
74027044|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.5|||||TWO_SIDED|95.0|8.15|16.23|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.23|8.15|
73914354|NCT03000439|147357789|OTHER||Difference in LS Mean|-9.3|||||TWO_SIDED|95.0|-32.35|13.75||||||CHQ01-Family Activities Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||13.75|-32.35|
73914355|NCT03000439|147357789|OTHER||Difference in LS Mean|-3.52|||||TWO_SIDED|95.0|-14.84|7.81||||||CHQ01-Family Cohesion Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||7.81|-14.84|
73914356|NCT03000439|147357789|OTHER||Difference in LS Mean|-20.42|||||TWO_SIDED|95.0|-79.03|38.18||||||CHQ01-Family Cohesion Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||38.18|-79.03|
74085745|NCT04894084|147725662|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|56.5||||0.678|TWO_SIDED|95.0|34.0|77.0|||Exact test in the binomial distribution|||||77|34|0.678
73914357|NCT03000439|147357792|OTHER||Difference in LS Mean|-0.24|||||TWO_SIDED|95.0|-1.02|0.54||||||CHAQ-Discomfort Index at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.54|-1.02|
73914358|NCT03000439|147357792|OTHER||Difference in LS Mean|0.54|||||TWO_SIDED|95.0|-0.49|1.57||||||CHAQ-Discomfort Index at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.57|-0.49|
73914359|NCT03000439|147357792|OTHER||Difference in LS Mean|0.47|||||TWO_SIDED|95.0|-1.01|0.9||||||CHAQ-Discomfort Index at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.90|-1.01|
73914360|NCT03000439|147357792|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.49|1.58||||||CHAQ-Discomfort Index at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.58|-0.49|
73965649|NCT04950127|147467245|SUPERIORITY||Mean Difference (Net)|-0.72||||0.001|TWO_SIDED|95.0|-1.15|-0.28|||Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Monthly Itch score (MIS), Visit\*Baseline MIS interaction, Baseline Concomitant Itch Medication.||-0.28|-1.15|0.001
74027045|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|5.75|11.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||11.25|5.75|
74027046|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|20.0|||||TWO_SIDED|95.0|12.99|30.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||30.76|12.99|
73859496|NCT00355342|147264923|EQUIVALENCE|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|0.06|1.49|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment\*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status.|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, \<7, \>=7). Slope estimates based on treatment\*time via repeated measures model with unstructured covariance.|1.49|0.06|
73859497|NCT00355342|147264924|EQUIVALENCE|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.78|0.24|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment\*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, \<7, \>=7). Slope estimates based on treatment\*time via repeated measures model with unstructured covariance.|0.24|-0.78|
73859498|NCT00434759|147264925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.82|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value is not adjusted for multiple comparisons|ANOVA|We report the interaction effect.|The reported interaction effect is significant (p\< .05) in favour of standard therapy.|||||<0.05
73859499|NCT00434759|147264926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.|||||<0.05
73859500|NCT00434759|147264927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||<|0.05||95.0||||p-value is not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.|||||<0.05
73859501|NCT00434759|147264928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction is not significant.|||||<0.05
73859502|NCT00434759|147264929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|||<|0.05||95.0||||priori threshold for statistical significance ist 0.05 p-value ist nor adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is significant (p \< .05) in favour of standard therapy|||||<0.05
73859503|NCT04030247|147264956|OTHER|||||||0.03|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.03
73859504|NCT04030247|147264957|OTHER|||||||0.16|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.16
73965650|NCT04950127|147467246|SUPERIORITY||Mean Difference (Net)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.07|-0.34||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Week, Week\*Treatment Group interaction, Baseline Weekly Itch score (WIS), Visit\*Baseline WIS interaction, Baseline Concomitant Itch Medication.||-0.34|-1.07|<0.001
73914361|NCT03000439|147357792|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.98|1.45||||||CHAQ-Discomfort Index at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.45|-0.98|
73914362|NCT03000439|147357792|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.51|1.14||||||CHAQ-Discomfort Index at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.14|-0.51|
73914363|NCT03000439|147357792|OTHER||Difference in LS Mean|-0.42|||||TWO_SIDED|95.0|-1.87|1.03||||||CHAQ-Discomfort Index at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.03|-1.87|
73914364|NCT03000439|147357792|OTHER||Difference in LS Mean|-0.33|||||TWO_SIDED|95.0|-1.53|0.88||||||CHAQ-Discomfort Index at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.88|-1.53|
73965651|NCT04950127|147467247|SUPERIORITY||Mean Difference (Net)|-0.53||||0.024|TWO_SIDED|95.0|-0.98|-0.07||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Monthly sleep score (MSS), Visit\*Baseline MSS interaction, Baseline Concomitant Itch Medication.||-0.07|-0.98|0.024
73914365|NCT03000439|147357792|OTHER||Difference in LS Mean|-0.31|||||TWO_SIDED|95.0|-1.36|0.74||||||CHAQ-Discomfort Index at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.74|-1.36|
73914366|NCT03000439|147357792|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.55|0.69||||||CHAQ-Discomfort Index at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.55|
73914367|NCT03000439|147357792|OTHER||Difference in LS Mean|-0.31|||||TWO_SIDED|95.0|-1.01|0.39||||||CHAQ-Discomfort Index at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.39|-1.01|
73914368|NCT03000439|147357792|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-1.45|1.92||||||CHAQ-Discomfort Index at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.92|-1.45|
73914369|NCT03000439|147357792|OTHER||Difference in LS Mean|-0.09|||||TWO_SIDED|95.0|-0.87|0.69||||||CHAQ-Discomfort Index at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.87|
73914370|NCT03000439|147357801|OTHER||Difference in percentage|-30.18|||||TWO_SIDED|95.0|-53.43|-6.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||-6.94|-53.43|
73914371|NCT03000439|147357801|OTHER||Difference in percentage|-23.39|||||TWO_SIDED|95.0|-47.19|0.42|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||0.42|-47.19|
73914372|NCT03000439|147357801|OTHER||Difference in percentage|-0.12|||||TWO_SIDED|95.0|-23.99|23.76|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||23.76|-23.99|
73965652|NCT04950127|147467248|SUPERIORITY||Percentage difference|4.0||||0.539||95.0|-9.0|17.0||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and less than \[\<\]7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains Bile Acid Binding Resin \[BABR\], Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||17.0|-9.0|0.539
74085746|NCT04894084|147725664|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|69.6||||0.0931|TWO_SIDED|95.0|47.0|87.0||"High degree and Very high degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||87|47|0.0931
74085747|NCT04894084|147725665|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|87.0||||0.0005|TWO_SIDED|95.0|66.0|97.0|||Exact test in the binomial distribution|||||97|66|0.0005
73914373|NCT03000439|147357801|OTHER||Difference in percentage|6.68|||||TWO_SIDED|95.0|-17.2|30.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||30.56|-17.20|
73914374|NCT03000439|147357801|OTHER||Difference in percentage|13.13|||||TWO_SIDED|95.0|-9.92|36.19|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||36.19|-9.92|
73914375|NCT03000439|147357801|OTHER||Difference in percentage|0.23|||||TWO_SIDED|95.0|-24.24|24.7|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||24.70|-24.24|
73965653|NCT04950127|147467249|SUPERIORITY||Percentage Difference|13.0||||0.043|TWO_SIDED|95.0|0.0|27.0||Adjusted for multiplicity; two-sided p-values \<0.05 were considered to be nominally significant as per SAP.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and \<7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||27.0|0.0|0.043
73965654|NCT04950127|147467250|SUPERIORITY||Percentage Difference|12.0||||0.058|TWO_SIDED|95.0|0.0|24.0||Adjusted for multiplicity; two-sided p-values \<0.05 were considered to be nominally significant as per SAP.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and \<7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||24.0|-0.0|0.058
73965655|NCT04950127|147467251|SUPERIORITY|Cognitive|Mean Difference (Net)|0.76||||0.176|TWO_SIDED|95.0|-0.34|1.86||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.86|-0.34|0.176
74085748|NCT02000531|147725668|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26|||>|0.05|TWO_SIDED|95.0|0.61|2.62|||Log Rank|||||2.62|0.61|>0.05
73859505|NCT04030247|147264958|OTHER|||||||0.03|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.03
73859506|NCT04030247|147264959|OTHER|||||||0.9|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.9
73859507|NCT04030247|147264960|OTHER|||||||0.5|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.5
73859508|NCT04030247|147264961|OTHER|||||||0.4|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.4
73859509|NCT04030247|147264963|OTHER|||||||0.6|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.6
73859510|NCT00823212|147264990|NON_INFERIORITY_OR_EQUIVALENCE|A 2-group Farrington-Manning test was used to test the 1-sided hypothesis of non-inferiority in differences with a non-inferiority margin of 3.5%. A p value \<0.05 would indicate non-inferiority and correspond to the upper limit of the 1-sided 95% confidence interval of the difference not exceeding 3.5%.|Difference in percent of participants|0.5||||0.001|ONE_SIDED|95.0||2.13|||Farrington-Manning test||The standard error for the difference was estimated according to the Farrington-Manning test.|Study had 89% statistical power to demonstrate non-inferiority for target lesion failure (TLF, accounting for an expected 1-year attrition rate of 5%), assuming a 1-year TLF rate of 5.5% for both stents.||2.13||0.001
73859511|NCT01344538|147265029|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73859512|NCT00929773|147265102|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73859513|NCT00929773|147265103|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<.0001
73859514|NCT00929773|147265104|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73859515|NCT00929773|147265105|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73859516|NCT00929773|147265106|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73859517|NCT00929773|147265107|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73859518|NCT02583230|147265128|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in PHQ-9 total scores over the eight-week study period.||||||.0005
73859519|NCT02583230|147265129|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in QIDS total scores over the eight-week study period.||||||.0008
73859520|NCT02124512|147265130|SUPERIORITY||||||>|0.05||||||The p-value was calculated to be \>0.05.|ANOVA|||Comparison of the pre- and post-treatment timecourse between untreated and rifaximin-treated participants.||||>0.05
73859521|NCT02124512|147265131|SUPERIORITY|||||||0.12||||||unpaired Student's t-test|t-test, 2 sided|||Treatment difference (change in placebo pre- and post-treatment versus change in rifaximin pre- and post-treatment).||||0.12
73859522|NCT01431014|147265133|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||>0.05
73859523|NCT00328653|147265161|SUPERIORITY|Comparisons of NOVA22007 0.05% to vehicle|M-H Chi-square|1.2187||||0.2699|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2699
73859524|NCT00328653|147265161|SUPERIORITY|Comparisons of NOVA22007 0.1% to vehicle|M-H Chi-square|1.2359||||0.2719|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2719
73859525|NCT00328653|147265164|SUPERIORITY|Comparisons of NOVA22007 0.05% to vehicle|M-H-Chi-square|4.2925||||0.0386|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0386
73859526|NCT00328653|147265164|SUPERIORITY|Comparisons of NOVA22007 0.1% to vehicle|M-H-Chi-square|5.3007||||0.0208|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0208
73859527|NCT00090233|147265182|NON_INFERIORITY_OR_EQUIVALENCE|Relative Risk ≤10.0 (non-inferiority margin).|relative risk|1.6||||0.006||95.0|0.4|6.4||"p≤ 10/11, where p is proportion of participants with intussusception in vaccine group relative to total number of participants with intussusception. Based on conditional binomial approach.~Adjusted for group-sequential design."|Exact binomial test|Exact binomial test adjusted for group-sequential design.||||6.4|0.4|0.006
73859528|NCT00090233|147265183|SUPERIORITY_OR_OTHER||Proportion|81.2|||<|0.001||95.0|72.9|87.8||p≥42%, where p is proportion of participants with ≥3-fold rise in antibody titer from Predose 1 to Postdose 3 in vaccine group. Based on binomial approach.|Exact binomial test|||||87.8|72.9|<0.001
74085749|NCT00317642|147725676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9951|TWO_SIDED|95.0|0.78|1.28|||Log Rank|||Full Analysis Set (FAS) population||1.28|0.78|0.9951
73859529|NCT00090233|147265184|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|74.0|||<|0.001||95.0|66.8|79.9||"Efficacy≥35%. Based on p≤.65/(.65+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, k is ratio of follow-up time; placebo/vaccine.~Based on conditional binomial approach."|Exact binomial test|Exact binomial test.|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|||79.9|66.8|<0.001
73914376|NCT03000439|147357801|OTHER||Difference in percentage|3.46|||||TWO_SIDED|95.0|-20.75|27.66|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||27.66|-20.75|
73914377|NCT03000439|147357801|OTHER||Difference in percentage|5.99|||||TWO_SIDED|95.0|-16.29|28.28|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||28.28|-16.29|
73965656|NCT04950127|147467251|SUPERIORITY|Emotional|Mean Difference (Net)|0.27||||0.403|TWO_SIDED|95.0|-0.36|0.89||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||0.89|-0.36|0.403
73965657|NCT04950127|147467251|SUPERIORITY|Fatigue|Mean Difference (Net)|1.59||||0.132|TWO_SIDED|95.0|-0.48|3.67||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||3.67|-0.48|0.132
73965658|NCT04950127|147467251|SUPERIORITY|Itch|Mean Difference (Net)|-0.58||||0.132|TWO_SIDED|95.0|-1.34|0.18||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||0.18|-1.34|0.132
73965659|NCT04950127|147467251|SUPERIORITY|Social|Mean Difference (Net)|-0.15||||0.836|TWO_SIDED|95.0|-1.57|1.27||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.27|-1.57|0.836
73965660|NCT04950127|147467251|SUPERIORITY|Symptoms|Mean Difference (Net)|0.45||||0.318|TWO_SIDED|95.0|-0.44|1.34||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.34|-0.44|0.318
73965661|NCT04950127|147467252|SUPERIORITY||Mean Difference (Net)|-0.37|||<|0.001|TWO_SIDED|95.0|-0.55|-0.2||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PGI-S score, Visit\*Baseline PGI-S score interaction, Baseline Concomitant Itch Medication.||-0.20|-0.55|<0.001
73965662|NCT04950127|147467253|SUPERIORITY||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.76|-0.21||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Concomitant Itch Medication.||-0.21|-0.76|<0.001
73965663|NCT03833167|147467257|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.07243|TWO_SIDED|95.0|0.53|1.1||One-sided p-value based on log-rank test stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|||1.10|0.53|0.07243
73914378|NCT03000439|147357801|OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-20.92|28.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||28.52|-20.92|
73914379|NCT03000439|147357801|OTHER||Difference in percentage|10.25|||||TWO_SIDED|95.0|-13.88|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||34.39|-13.88|
73965664|NCT03833167|147467258|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.87|2.48|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|||2.48|0.87|
73965665|NCT03833167|147467259|SUPERIORITY||Mean Difference (Final Values)|-3.41||||0.2227|TWO_SIDED|95.0|-8.91|2.09||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|Log Rank||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|||2.09|-8.91|0.2227
73965666|NCT03833167|147467260|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.1874|TWO_SIDED|95.0|-7.19|1.42||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|Log Rank||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|||1.42|-7.19|0.1874
74085750|NCT00317642|147725676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.4674|TWO_SIDED|95.0|0.81|1.57|||Log Rank|||Participants stratified by calculated strata remission after first pre-study induction regimen (CR1) \< 6 months||1.57|0.81|0.4674
74085751|NCT00317642|147725676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.3963|TWO_SIDED|95.0|0.58|1.24|||Log Rank|||Participants stratified by calculated strata CR1\>= 6 months||1.24|0.58|0.3963
74085752|NCT00317642|147725677|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - overall remission (OR)||||<0.0001
74085753|NCT00317642|147725677|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - Complete Remission (CR)||||0.0005
74085754|NCT00317642|147725677|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \<6 months \[Overall Remission (CR+CRi)\]||||0.0022
73859530|NCT00090233|147265185|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|94.5|||<|0.001||95.0|91.2|96.6||Rate Reduction\>0%|Poisson regression|"Poisson regression with generalized estimating equations.~Validated with Van Elteren's extension of Wilcoxon Rank Sum test."|Risk ratio of rate of hospitalizations and emergency department visits between treatment groups. Reported here are results after 12 additional emergency department visits were identified among placebo recipients and data were re-analyzed.|||96.6|91.2|<0.001
73965667|NCT05064735|147467293|SUPERIORITY||Estimated Treatment Difference|-10.48|||<|0.0001|TWO_SIDED|95.0|-12.34|-8.63|||ANCOVA|||The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.||-8.63|-12.34|<0.0001
73965668|NCT05064735|147467294|SUPERIORITY||Estimated Treatment Difference|-14.14|||<|0.0001|TWO_SIDED|95.0|-19.98|-8.3|||ANCOVA|||The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline WOMAC pain score as covariate.||-8.30|-19.98|<0.0001
73965669|NCT03547908|147467330|NON_INFERIORITY|A sample size of 240 participants randomized in a 1:1 ratio to 2 treatment groups, achieved 90% power to detect a non-inferiority margin of 12% between the 2 treatment groups. For the sample size and power computation, it is assumed that both treatment groups have a response rate of 91% (based on Gilead Studies GS-US-380-1489 and GS-US-380-1490), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|4.1|||||TWO_SIDED|95.001|-2.5|10.8|||||The difference in percentages of participants between groups and their 95.001% confidence intervals (CI)s were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||10.8|-2.5|
73965670|NCT03547908|147467330|SUPERIORITY|||||||0.2113|||||||Cochran-Mantel-Haenszel|The p-value was calculated from Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).||||||0.2113
73965671|NCT03547908|147467331|NON_INFERIORITY|A sample size of 240 participants provided 81% power to detect a non-inferiority margin of 12% between the 2 treatment groups. This assumed that both treatment groups have a response rate of 88% (based on Gilead Studies GS-US-320-0108 and GS-US-320-0110), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|16.6|||||TWO_SIDED|95.001|5.9|27.3|||||||The difference in percentages of participants with HBV DNA \< 29 IU/mL between treatment groups and its 95.001% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|27.3|5.9|
73965672|NCT03547908|147467331|SUPERIORITY|||||||0.0023|||||||Cochran-Mantel-Haenszel|The p-value was from CMH test stratified by baseline HBeAg status (positive vs negative) and HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).||||||0.0023
74085755|NCT00317642|147725677|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \>=6 months \[Overall Remission (CR+CRi)\]||||0.0019
74085756|NCT00317642|147725677|SUPERIORITY_OR_OTHER|||||||0.0353||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \<6 months \[Complete Remission (CR)\]||||0.0353
74085757|NCT00317642|147725677|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \>=6 months \[Complete Remission (CR)\]||||0.0096
74085758|NCT00317642|147725682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.0001|TWO_SIDED|95.0|0.49|0.8|||Log Rank|||Full Analysis Set (FAS) population.||0.80|0.49|0.0001
74085759|NCT00317642|147725682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.0131|TWO_SIDED|95.0|0.49|0.93|||Log Rank|Comparison P-value is from a log-rank test with no strata||Participants stratified by randomization strata CR1 \<6 months||0.93|0.49|0.0131
74085760|NCT00317642|147725682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.0022||95.0|0.4|0.83|||Log Rank|Comparison p-value is from a log-rank test with no strata.||Participants stratified by randomization strata CR1 \>=6 months||0.83|0.40|0.0022
74085761|NCT00317642|147725683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8209|TWO_SIDED|95.0|0.77|1.23|||Log Rank|||Full Analysis Set (FAS) population||1.23|0.77|0.8209
74085762|NCT00317642|147725683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5071|TWO_SIDED|95.0|0.81|1.53|||Log Rank|||||1.53|0.81|0.5071
74085763|NCT00317642|147725683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.2906|TWO_SIDED|95.0|0.59|1.17|||Log Rank|||||1.17|0.59|0.2906
74085764|NCT00317642|147725684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.49|0.79|||Log Rank|||Full Analysis Set (FAS) population.||0.79|0.49|<.0001
74085765|NCT00317642|147725684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0486|TWO_SIDED|95.0|0.53|1.01|||Log Rank|||||1.01|0.53|0.0486
74085766|NCT00317642|147725684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0002|TWO_SIDED|95.0|0.37|0.74|||Log Rank|||||0.74|0.37|0.0002
74085767|NCT00317642|147725685|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population||||<0.0001
74085768|NCT00317642|147725685|SUPERIORITY_OR_OTHER|||||||0.0088||95.0|||||Fisher Exact|||Participants stratified by randomization strata CR1 \<6 months.||||0.0088
74085769|NCT00317642|147725685|SUPERIORITY_OR_OTHER|||||||0.0017||95.0|||||Fisher Exact|||Participants stratified by randomization strata CR1 \>=6 months||||0.0017
74085770|NCT00317642|147725686|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
74085771|NCT00317642|147725686|SUPERIORITY_OR_OTHER|||||||0.0506||95.0|||||Fisher Exact|||||||0.0506
74085772|NCT00317642|147725686|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
74085773|NCT01239472|147725704|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73965673|NCT03547908|147467332|SUPERIORITY||Difference in Percentages|-0.3||||0.9427|TWO_SIDED|95.0|-8.9|8.3||P-value for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups was from the CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||8.3|-8.9|0.9427
74085774|NCT01239472|147725705|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73859531|NCT00090233|147265186|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|81.5|||<|0.001||95.0|74.9|86.7||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Estimated value is based on the worst episode scores.|||86.7|74.9|<0.001
73859532|NCT00090233|147265187|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|98.0|||<|0.001||95.0|88.3|100.0||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact binomial test|||||100|88.3|<0.001
73859533|NCT00090233|147265188|NON_INFERIORITY_OR_EQUIVALENCE|Difference (vaccine-placebo) in seroprotection rates was greater than -.10 (non-inferiority margin).|||||<|0.001||95.0||||p\<0.001 was obtained for all comparisons. pv - pp ≥-.10, where p is proportion of participants who achieved seroprotection in the vaccine and placebo groups, respectively.|Miettenen and Nurminen|||||||<0.001
73859534|NCT00090233|147265189|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis PT|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis PT was used for analysis.||1.1|0.7|<0.001
73859535|NCT00090233|147265189|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis FHA|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis FHA was used for analysis.||1.1|0.7|<0.001
73859536|NCT00090233|147265189|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis Pertactin|0.6||||0.193|TWO_SIDED|95.0|0.4|0.8|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis Pertactin was used for analysis.||0.8|0.4|0.193
73859537|NCT00090233|147265190|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 4|1.2|||<|0.001||95.0|1.0|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 4 was used for analysis.||1.4|1.0|<0.001
73859538|NCT00090233|147265190|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 6B|1.4|||<|0.001|TWO_SIDED|95.0|1.0|1.9|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 6B was used for analysis.||1.9|1.0|<0.001
73859539|NCT00090233|147265190|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 9V|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 9V was used for analysis.||1.3|0.9|<0.001
73859540|NCT00090233|147265190|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 14|1.0|||<|0.001|TWO_SIDED|95.0|0.7|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 14 was used for analysis.||1.3|0.7|<0.001
73859541|NCT00090233|147265190|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 18C|1.3|||<|0.001|TWO_SIDED|95.0|1.1|1.6|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 18C was used for analysis.||1.6|1.1|<0.001
73859542|NCT00090233|147265190|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 19F|1.1|||<|0.001|TWO_SIDED|95.0|0.8|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 19F was used for analysis.||1.4|0.8|<0.001
73859543|NCT00090233|147265190|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 23F|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.5|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 23F was used for analysis.||1.5|0.9|<0.001
73859544|NCT04754230|147265203|OTHER|||||||0.8|||||||two sided Z-test|This estimate uses two sided Z-test while assuming type I error=0.05||Comparison of bleeding at day 1||||0.8
73859545|NCT01459653|147265230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.884||||0.3038|TWO_SIDED|95.0|0.6989|1.1182|||Chi-squared|||||1.1182|0.6989|0.3038
73859546|NCT01459653|147265231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1897||||0.1432|TWO_SIDED|95.0|0.9428|1.5012|||Chi-squared|||||1.5012|0.9428|0.1432
73965674|NCT03547908|147467333|OTHER||Difference in least squares mean (LSM)|24.0||||0.1701|TWO_SIDED|95.0|-10.0|58.0|||ANOVA|The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||58|-10|0.1701
74085775|NCT01049412|147725719|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.55|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|90.0|-0.81|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.29|-0.81|<0.001
74085776|NCT01049412|147725720|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.56|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|90.0|-0.83|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.29|-0.83|<0.001
74085777|NCT01049412|147725721|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.242|TWO_SIDED|90.0|-0.28|0.05||The statistical significance level is 0.10.|Mixed Models Analysis|||||0.05|-0.28|0.242
74085778|NCT01049412|147725722|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.276
74027047|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|22.3|||||TWO_SIDED|95.0|16.5|30.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||30.06|16.50|
73859547|NCT01459653|147265232|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8794||||0.6483|TWO_SIDED|95.0|0.5063|1.5276|||Chi-squared|||||1.5276|0.5063|0.6483
73859548|NCT01459653|147265242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2989|||<|0.0001|TWO_SIDED|95.0|1.8113|2.9177|||Chi-squared|||||2.9177|1.8113|<0.0001
73859549|NCT01459653|147265243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4963|||<|0.0001|TWO_SIDED|95.0|0.373|0.6605|||Chi-squared|||||0.6605|0.3730|<0.0001
73859550|NCT01459653|147265244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9451||||0.7509|TWO_SIDED|95.0|0.6671|1.3391|||Chi-squared|||||1.3391|0.6671|0.7509
73859551|NCT01459653|147265245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2683||||0.0067|TWO_SIDED|95.0|1.068|1.5061|||Chi-squared|||||1.5061|1.0680|0.0067
73859552|NCT01459653|147265253|SUPERIORITY_OR_OTHER||Slope|1.0628|||<|0.0001|TWO_SIDED|95.0|0.6382|1.4874|||ANOVA|degrees of freedom: 4507||||1.4874|0.6382|<0.0001
73859553|NCT01459653|147265254|SUPERIORITY_OR_OTHER||Slope|-0.2739||||0.0103|TWO_SIDED|95.0|-0.4832|-0.0646|||ANOVA|degrees of freedom: 4507||||-0.0646|-0.4832|0.0103
73859554|NCT01459653|147265255|SUPERIORITY_OR_OTHER||Slope|0.3812|||<|0.0001|TWO_SIDED|95.0|0.233|0.5295|||ANOVA|degrees of freedom: 4495||||0.5295|0.2330|<0.0001
73859555|NCT01459653|147265263|SUPERIORITY_OR_OTHER||Slope|0.1031||||0.0677|TWO_SIDED|95.0|-0.0075|0.2136|||ANOVA|degrees of freedom: 4516||||0.2136|-0.0075|0.0677
73859556|NCT01459653|147265264|SUPERIORITY_OR_OTHER||Slope|0.0018||||0.8968|TWO_SIDED|95.0|-0.0259|0.0295|||ANOVA|degrees of freedom: 4516||||0.0295|-0.0259|0.8968
73859557|NCT01459653|147265265|SUPERIORITY_OR_OTHER||Slope|0.0741|||<|0.0001|TWO_SIDED|95.0|-0.0452|0.1029|||ANOVA|degrees of freedom: 4505||||0.1029|-0.0452|<0.0001
73859558|NCT01459653|147265273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.735||||0.2698|TWO_SIDED|95.0|0.4255|1.2698|||Chi-squared|||||1.2698|0.4255|0.2698
73859559|NCT01459653|147265274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
73859560|NCT01459653|147265291|SUPERIORITY_OR_OTHER|||||||0.5977|TWO_SIDED||||||Log Rank|||||||0.5977
73859561|NCT01459653|147265292|SUPERIORITY_OR_OTHER|||||||0.2435|TWO_SIDED||||||Log Rank|||||||0.2435
73859562|NCT01459653|147265293|SUPERIORITY_OR_OTHER|||||||0.763|TWO_SIDED||||||Log Rank|||||||0.7630
73859563|NCT01459653|147265294|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED||||||Log Rank|||||||0.3830
73859564|NCT01459653|147265295|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Log Rank|||||||0.0002
73859565|NCT01459653|147265296|SUPERIORITY_OR_OTHER|||||||0.0301|TWO_SIDED||||||Log Rank|||||||0.0301
73859566|NCT01459653|147265297|SUPERIORITY_OR_OTHER||Slope|0.92||||0.0683|TWO_SIDED|95.0|0.84|1.01|||Regression, Logistic|degrees of freedom: 3181||GCSF treatment decision (under vs correct) as predictor for ANC||1.01|0.84|0.0683
73859567|NCT01459653|147265297|SUPERIORITY_OR_OTHER||Slope|0.89||||0.0019|TWO_SIDED|95.0|0.82|0.96|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Over vs correct) as predictor for ANC||0.96|0.82|0.0019
73859568|NCT01459653|147265297|SUPERIORITY_OR_OTHER||Slope|1.04||||0.4469|TWO_SIDED|95.0|0.94|1.15|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Under vs over) as predictor for ANC||1.15|0.94|0.4469
73859569|NCT01459653|147265297|SUPERIORITY_OR_OTHER||Slope|1.11||||0.0079|TWO_SIDED|95.0|1.03|1.19|||Regression, Logistic|||Study drug dose (higher vs lower) as predictor for ANC||1.19|1.03|0.0079
73859570|NCT01459653|147265297|SUPERIORITY_OR_OTHER||Slope|0.81||||0.0004|TWO_SIDED|95.0|0.72|0.91|||Regression, Logistic|||Tumor type (hematological vs solid) as predictor for ANC||0.91|0.72|0.0004
73859571|NCT01459653|147265297|SUPERIORITY_OR_OTHER||Slope|0.86|||<|0.0001|TWO_SIDED|95.0|0.8|0.92|||Regression, Logistic|||Patient gender (female vs male) as predictor for ANC||0.92|0.80|<0.0001
73859572|NCT01459653|147265297|SUPERIORITY_OR_OTHER||Slope|1.04||||0.0235|TWO_SIDED|95.0|1.01|1.08|||Regression, Linear|||ECOG (per 1 point) as predictor for ANC||1.08|1.01|0.0235
73859573|NCT01459653|147265297|SUPERIORITY_OR_OTHER||Slope|1.03|||<|0.0001|TWO_SIDED|95.0|1.02|1.05|||Regression, Linear|||Hb (per g/dL) as predictor for ANC||1.05|1.02|<0.0001
73859574|NCT01459653|147265298|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.09||||0.0003|TWO_SIDED||||||ANCOVA||The intra-class correlation coefficient (ICC) was computed to quantify the variability in patient outcome attributable to within-center variability before any patient-level determinants are considered.|ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the center-level.||||0.0003
74085779|NCT01049412|147725722|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.119
73859575|NCT01459653|147265298|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.41|||<|0.0001|TWO_SIDED||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the patient within center-level.||||<0.0001
73859576|NCT01459653|147265298|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.5|||<|0.0001|TWO_SIDED||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the within-patient level.||||<0.0001
73859577|NCT01459653|147265303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.544||||0.003|TWO_SIDED|95.0|0.365|0.812|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for CIN grade 4 episode||0.812|0.365|0.003
73859578|NCT01459653|147265303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.795|||<|0.001|TWO_SIDED|95.0|3.242|7.092|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN grade 4 episode||7.092|3.242|<0.001
73859579|NCT01459653|147265303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.083|||<|0.001|TWO_SIDED|95.0|3.242|7.092|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN grade 4 episode||7.092|3.242|<0.001
73859580|NCT01459653|147265303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||<|0.001|TWO_SIDED|95.0|1.542|3.925|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode||3.925|1.542|<0.001
73859581|NCT01459653|147265303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.452||||0.003|TWO_SIDED|95.0|0.267|0.766|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode||0.766|0.267|0.003
73914380|NCT03000439|147357801|OTHER||Difference in percentage|20.62|||||TWO_SIDED|95.0|-3.43|44.67|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||44.67|-3.43|
74027048|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.8|||||TWO_SIDED|95.0|7.07|13.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||13.63|7.07|
74027049|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.0|||||TWO_SIDED|95.0|8.82|16.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.34|8.82|
74085780|NCT01049412|147725724|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.3|STANDARD_ERROR_OF_MEAN|0.35||0.392|TWO_SIDED|90.0|-0.28|0.88||"The statistical significance level is 0.10.~P-value is for 0300 hour BG."|Mixed Models Analysis|||||0.88|-0.28|0.392
74085781|NCT01049412|147725724|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.24|STANDARD_ERROR_OF_MEAN|0.33||0.464|TWO_SIDED|90.0|-0.79|0.3||"The statistical significance level is 0.10.~P-value is for morning FBG."|Mixed Models Analysis|||||0.30|-0.79|0.464
73914381|NCT03000439|147357801|OTHER||Difference in percentage|20.62|||||TWO_SIDED|95.0|-3.43|44.67|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||44.67|-3.43|
73914382|NCT03000439|147357801|OTHER||Difference in percentage|17.4|||||TWO_SIDED|95.0|-7.03|41.82|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||41.82|-7.03|
73914383|NCT03000439|147357802|OTHER||Difference in percentage|-26.61|||||TWO_SIDED|95.0|-50.42|-2.81|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||-2.81|-50.42|
73914384|NCT03000439|147357802|OTHER||Difference in percentage|-20.16|||||TWO_SIDED|95.0|-43.91|3.59|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||3.59|-43.91|
73914385|NCT03000439|147357802|OTHER||Difference in percentage|-9.79|||||TWO_SIDED|95.0|-34.31|14.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||14.72|-34.31|
73914386|NCT03000439|147357802|OTHER||Difference in percentage|0.23|||||TWO_SIDED|95.0|-24.24|24.7|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||24.70|-24.24|
73914387|NCT03000439|147357802|OTHER||Difference in percentage|10.25|||||TWO_SIDED|95.0|-13.88|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||34.39|-13.88|
74085782|NCT01049412|147725724|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.48|STANDARD_ERROR_OF_MEAN|0.33||0.151|TWO_SIDED|90.0|-1.04|0.07||"The statistical significance level is 0.10.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis|||||0.07|-1.04|0.151
73914388|NCT03000439|147357802|OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-27.67|21.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||21.68|-27.67|
73914389|NCT03000439|147357802|OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-27.67|21.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||21.68|-27.67|
73914390|NCT03000439|147357802|OTHER||Difference in percentage|-6.91|||||TWO_SIDED|95.0|-30.65|16.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||16.83|-30.65|
73914391|NCT03000439|147357802|OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-20.92|28.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||28.52|-20.92|
74027050|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|13.0|||||TWO_SIDED|95.0|10.21|16.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.66|10.21|
74027051|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.6|||||TWO_SIDED|95.0|5.86|9.94|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.94|5.86|
74085783|NCT01049412|147725724|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.54|STANDARD_ERROR_OF_MEAN|0.3||0.079|TWO_SIDED|90.0|-1.05|-0.03||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis|||||-0.03|-1.05|0.079
73914392|NCT03000439|147357802|OTHER||Difference in percentage|7.03|||||TWO_SIDED|95.0|-17.43|31.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||31.48|-17.43|
73914393|NCT03000439|147357802|OTHER||Difference in percentage|17.74|||||TWO_SIDED|95.0|-7.03|42.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||42.52|-7.03|
73914394|NCT03000439|147357802|OTHER||Difference in percentage|14.52|||||TWO_SIDED|95.0|-10.52|39.55|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||39.55|-10.52|
73914395|NCT03000439|147357802|OTHER||Difference in percentage|17.74|||||TWO_SIDED|95.0|-7.03|42.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||42.52|-7.03|
74085784|NCT01049412|147725724|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.52|STANDARD_ERROR_OF_MEAN|0.28||0.07|TWO_SIDED|90.0|-0.99|-0.05||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis|||||-0.05|-0.99|0.070
73914396|NCT03000439|147357803|OTHER||Difference in percentage|-15.09|||||TWO_SIDED|95.0|-34.29|4.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||4.10|-34.29|
73914397|NCT03000439|147357803|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||4.65|-29.08|
73914398|NCT03000439|147357803|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||7.10|-25.07|
73914399|NCT03000439|147357803|OTHER||Difference in percentage|4.61|||||TWO_SIDED|95.0|-12.01|21.23|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||21.23|-12.01|
73914400|NCT03000439|147357803|OTHER||Difference in percentage|4.61|||||TWO_SIDED|95.0|-12.01|21.23|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||21.23|-12.01|
73965675|NCT03547908|147467334|OTHER||Difference in Least Squares Means|30.0||||0.1853|TWO_SIDED|95.0|-14.0|74.0||P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|||74|-14|0.1853
73965676|NCT03547908|147467335|OTHER||Difference in least squares mean (LSM)|0.59||||0.2839|TWO_SIDED|95.0|-0.49|1.67|||ANOVA|The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||1.67|-0.49|0.2839
73965677|NCT03547908|147467336|OTHER||Difference in LSM|0.13||||0.8456|TWO_SIDED|95.0|-1.2|1.46||P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|ANOVA||Difference in LSM and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|||1.46|-1.20|0.8456
73965678|NCT03547908|147467337|SUPERIORITY|P-value for the superiority test comparing the percentages of participants with HBV DNA \< 29 IU/mL between treatment groups was from the CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|Difference in Percentages|2.6||||0.6367|TWO_SIDED|95.0|-8.3|13.4|||Cochran-Mantel-Haenszel|||The difference in percentages of participants with HBV DNA \< 29 IU/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).||13.4|-8.3|0.6367
73965679|NCT03547908|147467338|OTHER||Difference in Percentages|17.1||||0.0655|TWO_SIDED|95.0|-1.5|35.7|||Cochran-Mantel-Haenszel|P-value was calculated from CMH tests stratified by baseline HBeAg status (positive vs negative) and HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|The difference in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||35.7|-1.5|0.0655
73965680|NCT03547908|147467339|OTHER||Difference in Percentages|14.1||||0.1253|TWO_SIDED|95.0|-4.3|32.6|||Cochran-Mantel-Haenszel|P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs \>= 8 log10 IU/mL).|Difference in the proportion between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs \>= 8 log10 IU/mL).|||32.6|-4.3|0.1253
73965681|NCT03547908|147467340|OTHER||Difference in Percentages|7.1||||0.0591|TWO_SIDED|95.0|-0.8|15.0|||Cochran-Mantel-Haenszel|P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative)and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|Difference in the percentages between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||15.0|-0.8|0.0591
73914401|NCT03000439|147357803|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||7.10|-25.07|
73914402|NCT03000439|147357803|OTHER||Difference in percentage|-11.87|||||TWO_SIDED|95.0|-30.52|6.79|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||6.79|-30.52|
73914403|NCT03000439|147357803|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||13.94|-24.08|
73914404|NCT03000439|147357803|OTHER||Difference in percentage|-5.41|||||TWO_SIDED|95.0|-22.7|11.87|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||11.87|-22.70|
73914405|NCT03000439|147357803|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||8.61|-31.65|
73914406|NCT03000439|147357803|OTHER||Difference in percentage|-1.84|||||TWO_SIDED|95.0|-20.16|16.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||16.48|-20.16|
73965682|NCT03547908|147467341|OTHER||Difference in Percentages|9.3||||0.0655|TWO_SIDED|95.0|-0.7|19.2||P value was from the CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL). Statistically significant values are shown in bold.|Cochran-Mantel-Haenszel||Differences in percentages between treatment groups and their 95% CI were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||19.2|-0.7|0.0655
73965683|NCT03358875|147467348|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.527|0.778||OS in the ITT population was tested at one-sided p value boundary of 0.0120.|1-sided Log Rank Test|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% confidence interval (CI).|||0.778|0.527|<0.0001
73914407|NCT03000439|147357803|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||9.38|-26.66|
73914408|NCT03000439|147357803|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||13.94|-24.08|
73914409|NCT03000439|147357804|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||4.65|-29.08|
73914410|NCT03000439|147357804|OTHER||Difference in percentage|-14.75|||||TWO_SIDED|95.0|-35.32|5.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||5.83|-35.32|
73914411|NCT03000439|147357804|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||11.32|-27.91|
73914412|NCT03000439|147357804|OTHER||Difference in percentage|1.73|||||TWO_SIDED|95.0|-17.48|20.93|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||20.93|-17.48|
73965684|NCT03358875|147467349|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.407|0.702||OS in the PD-L1 positive analysis set was tested at the one-sided p-value boundary of 0.025.|1-sided Log Rank Test|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).||||0.702|0.407|<0.0001
73965685|NCT03358875|147467350|SUPERIORITY||Odds Ratio (OR)|3.86|||<|0.0001|TWO_SIDED|95.0|2.336|6.393|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, line of therapy, and PDL1 expression.||||6.393|2.336|<0.0001
73965686|NCT03358875|147467351|SUPERIORITY||Odds Ratio (OR)|8.04|||<|0.0001|TWO_SIDED|95.0|3.721|17.379|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology and line of therapy.||||17.379|3.721|<0.0001
73965687|NCT03358875|147467352|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.176|0.536|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.536|0.176|<0.0001
74027052|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.2|||||TWO_SIDED|95.0|8.05|18.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.34|8.05|
74027053|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.2|||||TWO_SIDED|95.0|12.77|23.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||23.24|12.77|
73914413|NCT03000439|147357804|OTHER||Difference in percentage|1.38|||||TWO_SIDED|95.0|-16.15|18.91|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||18.91|-16.15|
73914414|NCT03000439|147357804|OTHER||Difference in percentage|-5.41|||||TWO_SIDED|95.0|-22.7|11.87|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||11.87|-22.70|
73914415|NCT03000439|147357804|OTHER||Difference in percentage|-11.87|||||TWO_SIDED|95.0|-30.52|6.79|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||6.79|-30.52|
73914416|NCT03000439|147357804|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||13.94|-24.08|
74027054|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.5|||||TWO_SIDED|95.0|8.01|16.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.45|8.01|
73914417|NCT03000439|147357804|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||9.38|-26.66|
73914418|NCT03000439|147357804|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||8.61|-31.65|
73914419|NCT03000439|147357804|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||11.32|-27.91|
73914420|NCT03000439|147357804|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||11.32|-27.91|
73965688|NCT03358875|147467353|SUPERIORITY||Hazard Ratio (HR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.066|0.37|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.370|0.066|<0.0001
73965689|NCT03358875|147467354|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.528|0.745|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.745|0.528|<0.0001
74085785|NCT01049412|147725724|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.86|STANDARD_ERROR_OF_MEAN|0.32||0.008|TWO_SIDED|90.0|-1.39|-0.34||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG."|Mixed Models Analysis|||||-0.34|-1.39|0.008
73914421|NCT03000439|147357804|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||13.94|-24.08|
73914422|NCT03000439|147357807|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||7.10|-25.07|
73965690|NCT03358875|147467355|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.285|0.494|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% confidence interval (CI).|||0.494|0.285|<0.0001
73914423|NCT03000439|147357807|OTHER||Difference in percentage|-19.01|||||TWO_SIDED|95.0|-35.25|-2.76|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||-2.76|-35.25|
73914424|NCT03000439|147357807|OTHER||Difference in percentage|-15.44|||||TWO_SIDED|95.0|-32.98|2.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||2.10|-32.98|
73965691|NCT03358875|147467356|OTHER||Least Squares (LS) Mean Difference|5.7||||0.0008|TWO_SIDED|95.0|2.38|9.07|||Mixed Models Analysis|||The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||9.07|2.38|0.0008
73965692|NCT03358875|147467357|OTHER||LS Mean Difference|-8.3||||0.0007|TWO_SIDED|95.0|-13.02|-3.51|||Mixed Models Analysis|||Analysis of Change from Baseline in Coughing Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||-3.51|-13.02|0.0007
73965693|NCT03358875|147467357|OTHER||LS Mean Difference|-3.2||||0.0579|TWO_SIDED|95.0|-6.52|0.11|||Mixed Models Analysis|||Analysis of Change from Baseline in Dyspnoea Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||0.11|-6.52|0.0579
73965694|NCT03358875|147467357|OTHER||LS Mean Difference|-2.2||||0.2472|TWO_SIDED|95.0|-6.05|1.56|||Mixed Models Analysis|||Analysis of Change from Baseline in Chest Pain Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||1.56|-6.05|0.2472
74027055|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.0|||||TWO_SIDED|95.0|7.89|18.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.19|7.89|
74027056|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.7|||||TWO_SIDED|95.0|5.02|8.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.92|5.02|
74085786|NCT01049412|147725724|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.89|STANDARD_ERROR_OF_MEAN|0.29||0.003|TWO_SIDED|90.0|-1.38|-0.41||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis|||||-0.41|-1.38|0.003
74085787|NCT01049412|147725724|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-1.1|STANDARD_ERROR_OF_MEAN|0.33||0.001|TWO_SIDED|90.0|-1.64|-0.55||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis|||||-0.55|-1.64|0.001
73914425|NCT03000439|147357807|OTHER||Difference in percentage|-12.56|||||TWO_SIDED|95.0|-27.22|2.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||2.10|-27.22|
74027057|NCT01025336|147607526|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.7|||||TWO_SIDED|95.0|3.52|6.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.29|3.52|
74027058|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.7|||||TWO_SIDED|95.0|3.05|4.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.49|3.05|
74085788|NCT01049412|147725729|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||The statistical significance level is 0.10.|Negative Binomial Model|||||||0.037
73914426|NCT03000439|147357807|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||7.10|-25.07|
73914427|NCT03000439|147357807|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||4.65|-29.08|
73965695|NCT03599648|147467360|SUPERIORITY|||||||0.361||||||baseline versus immediately after 16-week BPT-E intervention|t-test, 2 sided|||||||.361
73965696|NCT03599648|147467360|SUPERIORITY|||||||0.126||||||baseline versus 6 months after BPT-E intervention|t-test, 2 sided|||||||.126
73965697|NCT03599648|147467360|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
74085789|NCT01049412|147725730|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|90.0|-0.69|-0.25||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.25|-0.69|<0.001
73965698|NCT03599648|147467360|SUPERIORITY|||||||0||||||baseline versus immediately after 16 week BPT-M intervention|t-test, 2 sided|||||||.000
73965699|NCT03599648|147467360|SUPERIORITY|||||||0||||||baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
73965700|NCT03599648|147467360|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
73914428|NCT03000439|147357807|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||9.38|-26.66|
73914429|NCT03000439|147357807|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||9.38|-26.66|
73914430|NCT03000439|147357807|OTHER||Difference in percentage|-1.84|||||TWO_SIDED|95.0|-20.16|16.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||16.48|-20.16|
73914431|NCT03000439|147357807|OTHER||Difference in percentage|-4.72|||||TWO_SIDED|95.0|-25.17|15.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||15.72|-25.17|
73914432|NCT03000439|147357807|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||11.32|-27.91|
73914433|NCT03000439|147357807|OTHER||Difference in percentage|-4.72|||||TWO_SIDED|95.0|-25.17|15.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||15.72|-25.17|
74085790|NCT01280617|147725731|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Continuous variables analyzed using 2-tailed t test or Mann Whitney tes.. Categorical variables analyzed using Chi-Square or Fisher's Exact test||||||<0.05
74085791|NCT01280617|147725731|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73914434|NCT03000439|147357807|OTHER||Difference in percentage|2.07|||||TWO_SIDED|95.0|-18.53|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||22.68|-18.53|
73914435|NCT02370160|147357808|OTHER||||||||||||||||||In Phase I: There were 9 subjects treated on dose level 1 (60 µg/kg/dose). There were 6 subjects treated on Dose level 2 (80 µg/kg/dose). There were four DLT events happened in Phase I. One was treated on dose level 1 and the other three were treated on dose level 2. Therefore the MTD was dose level 1.|||
73914436|NCT00592384|147357815|SUPERIORITY_OR_OTHER||||||<|0.025||||||Bonferroni corrected for two primary comparisons|Mixed Models Analysis|see above||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants' intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.||||<.025
73914437|NCT00592384|147357828|SUPERIORITY_OR_OTHER||||||<|0.025||||||Bonferroni corrected for two primary outcomes|Mixed Models Analysis|||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants' intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.||||<.025
73965701|NCT03599648|147467361|SUPERIORITY|||||||0.035||||||Baseline versus immediately following 16-week BPT-E intervention|t-test, 2 sided|||||||.035
73965702|NCT03599648|147467361|SUPERIORITY|||||||0.001||||||Baseline versus 6-months after BPT-E intervention|t-test, 2 sided|||||||.001
73965703|NCT03599648|147467361|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
73965704|NCT03599648|147467361|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-M intervention|t-test, 2 sided|||||||.000
73965705|NCT03599648|147467361|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
73965706|NCT03599648|147467361|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
73965707|NCT03599648|147467362|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-E intervention|t-test, 2 sided|||||||.000
73965708|NCT03599648|147467362|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-E intervention|t-test, 2 sided|||||||.000
73965709|NCT03599648|147467362|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
73965710|NCT03599648|147467362|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-M intervention|t-test, 2 sided|||||||.000
73965711|NCT03599648|147467362|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
74027059|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.3|||||TWO_SIDED|95.0|1.92|2.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||2.81|1.92|
74027060|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.83|2.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||2.50|1.83|
73965712|NCT03599648|147467362|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
73965713|NCT03433339|147467378|SUPERIORITY||||||=|0.04||||||p-value threshold for statistical significance \<0.05|ANOVA|Mixed ANOVA model considering all available data.||||||=0.040
73965714|NCT05332340|147467406|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.683|TWO_SIDED||||||Kruskal-Wallis|||||||0.683
73965715|NCT03137771|147467419|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.66|TWO_SIDED|95.0|0.68|1.4|||Log Rank|Two-sided test|Reference level = systemic therapy. Cox proportional hazards model stratified by histology (non-squamous vs squamous) and systemic therapy (immunotherapy-based regimens vs chemotherapy- only regimens).|Based on expected 6- and 12-month PFS rates of approximately 60% and 39% for the standard arm, assuming approximately exponential distributions, at least 138 PFS events are needed to detect a hazard ratio of 0.6 (a hazard reduction of 40%) with 95% power and a one-sided significance level of 0.15. The Cox proportional hazards model is stratified by histology and systemic therapy type. The hazard ratio estimate must be ≤ 0.83 for the study to proceed to the phase III component.||1.40|0.68|0.66
73965716|NCT03289039|147467450|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.98|TWO_SIDED|95.0|0.27|4.12|||Log Rank|||||4.12|0.27|0.98
73914438|NCT01001377|147357845|SUPERIORITY_OR_OTHER_LEGACY||Stratified Cox proportional hazard ratio|0.966|||||TWO_SIDED|95.0|0.839|1.113|||||Hazard ratio is presented as panitumumab : cetuximab. A value \< 1.0 indicates a lower average event rate and longer time to event for panitumumab relative to cetuximab.|Cox proportional hazards model stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).||1.113|0.839|
73914439|NCT01001377|147357845|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall survival non-inferiority hypothesis based on an asymptotic normal score was tested at a 1-sided 2.5% significance level. A value \< -1.96 indicates non-inferiority at a significance level of 1-sided 0.025.|Normal score|-3.19||||0.0007||||||A synthesis approach with an asymptotic standard normal test statistic|Asymptotic standard normal test|||A synthesis approach with an asymptotic standard normal test statistic based on the logarithm of the hazard ratio was used to test the hypothesis that panitumumab is non-inferior to cetuximab for overall survival (ie, that panitumumab retains at least 50% of the overall survival benefit of cetuximab relative to best supportive care).||||0.0007
73914440|NCT01001377|147357847|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.58|||||Common treatment odds ratio stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).|||1.58|0.83|
73914441|NCT01001377|147357851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0126|||||TWO_SIDED|95.0|-0.0353|0.0605|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||0.0605|-0.0353|
73914442|NCT01001377|147357852|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6745|||||TWO_SIDED|95.0|-4.9331|1.5841|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||1.5841|-4.9331|
73914443|NCT01001377|147357853|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.0372|||||TWO_SIDED|95.0|-2.3267|4.401|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||4.4010|-2.3267|
73914444|NCT01001377|147357854|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.5836|||||TWO_SIDED|95.0|-3.0269|4.1941|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||4.1941|-3.0269|
73914445|NCT01001377|147357855|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1998|||||TWO_SIDED|95.0|-6.0093|5.6098|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||5.6098|-6.0093|
74088398|NCT00107042|147730237|SUPERIORITY_OR_OTHER|||||||0.2954|||||||Fisher Exact|||The study wasn't powered to compare the 2 arms but to detect a large difference. A quantitative antibody (a'body) response was measured, but for sample size and power considerations, the outcome was considered to be binary. The primary analysis involved straightforward computation of point estimates and exact confidence intervals of immunogenicity in each arm. The data for primary analysis used the Intent-to-Treat for subjects who were vaccinated at least once. Missing titers were not imputed.||||0.2954
73914446|NCT00964860|147357874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.05||0.001|ONE_SIDED|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%. Units on the MGI Scale.|||||0.001
73914447|NCT00964860|147357875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.05||0.004|ONE_SIDED|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%|||||0.004
73914448|NCT03716024|147357876|SUPERIORITY||Mean Difference (Final Values)|13.6|||||TWO_SIDED|95.0|1.3|26.0|||||omadacycline minus linezolid|||26.0|1.3|
73914449|NCT03716024|147357877|SUPERIORITY||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-1.7|11.4|||||omadacycline minus linezolid|||11.4|-1.7|
73914450|NCT03716024|147357878|SUPERIORITY||Mean Difference (Final Values)|13.8|||||TWO_SIDED|95.0|0.9|26.7|||||omadacycline minus linezolid|||26.7|0.9|
73914451|NCT03716024|147357879|SUPERIORITY||Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-5.3|14.0||||||||14.0|-5.3|
73914452|NCT03600818|147357911|SUPERIORITY||Difference in percentage|18.0|||=|0.0193|TWO_SIDED|95.0|4.15|31.82||Threshold for significance at 0.05 level.|Fisher Exact|||||31.82|4.15|=0.0193
73914453|NCT03600818|147357912|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Wilcoxon rank-sum test|||A hierarchical testing procedure was used to control the overall type I error. If the primary endpoint reaches statistical significance then the secondary endpoint for total cumulative CS dose was tested next.||||<0.0001
73914454|NCT03416946|147357940|SUPERIORITY|||||||0.79||||||Post-op HKA angle|t-test, 2 sided|||||||0.790
73914455|NCT00044083|147357972|OTHER||||||<|0.0001||||||Diagnosis effect on placebo|ANOVA|||||||<0.0001
73914456|NCT00044083|147357972|OTHER|||||||0.0034||||||Drug Effect on Patients|ANOVA|||||||0.0034
73914457|NCT00044083|147357973|OTHER||||||<|0.0001||||||Diagnosis Effect on Placebo in right DLPFC|ANOVA|||||||<0.0001
73914458|NCT00044083|147357973|OTHER|||||||0.014||||||Diagnosis Effect of Placebo in left DLPFC|ANOVA|||||||0.014
73914459|NCT00044083|147357974|OTHER|||||||0.05||||||Drug Effect across both groups in left DLPFC|ANOVA|||||||0.05
73914460|NCT00044083|147357974|OTHER|||||||0.32||||||Drug Effect across both groups in right DLPFC|ANOVA|||||||0.32
73914461|NCT00044083|147357975|OTHER|||||||0.05||||||The Effect of Drug on Patients with Schizophrenia in right DLPFC|t-test, 1 sided|||||||0.05
73914462|NCT00044083|147357975|OTHER|||||||0.078||||||Effect of Drug on Patients with Schizophrenia in left DLPFC|t-test, 1 sided|||||||0.078
73914463|NCT00044083|147357976|OTHER|||||||0.05||||||Drug Effect on Healthy Volunteers in left DLPFC|t-test, 1 sided|||||||0.05
73914464|NCT00044083|147357976|OTHER|||||||0.73||||||Drug Effect on Healthy Volunteers in right DLPFC|t-test, 1 sided|||||||0.73
73914465|NCT00044083|147357977|OTHER||||||<|0.0001|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in right DLPFC||||||<0.0001
73914466|NCT00044083|147357977|OTHER|||||||0.167|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in left DLPFC||||||0.167
73914467|NCT00044083|147357978|OTHER|||||||0.189||||||Drug by Genotype Effect in left DLPFC|ANOVA|||||||0.189
73914468|NCT00044083|147357978|OTHER|||||||0.041||||||Drug Effect on Val/Val Genotype in left DLPFC|t-test, 1 sided|||||||0.041
73914469|NCT00044083|147357978|OTHER|||||||0.718||||||Drug Effect on Val/Met Genotype in left DLPFC|t-test, 1 sided|||||||0.718
73914470|NCT00044083|147357978|OTHER|||||||0.469||||||Drug Effect of Met/Met Genotype in left DLPFC|t-test, 1 sided|||||||0.469
73914471|NCT00044083|147357979|OTHER|||||||0.7||||||Drug Effect on Positive Syndrome for Patients|t-test, 1 sided|||||||0.7
73914472|NCT00044083|147357979|OTHER|||||||0.4||||||Drug Effect on Negative Syndrome for Patients|t-test, 1 sided|||||||0.4
73914473|NCT00044083|147357979|OTHER|||||||0.12||||||Drug Effect on General Pathology for Patients|t-test, 1 sided|||||||0.12
73914474|NCT01112865|147357984|SUPERIORITY_OR_OTHER|||||||0.6858|TWO_SIDED|||||Binomial test against the null hypothesis|binomial test|||Null hypothesis: percentage of participants preferring Genotropin Mark VII injection pen = 50%||||0.6858
73914475|NCT05673889|147358003|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|192.2|||||TWO_SIDED|90.0|166.56|221.79|||||The ratios (and 90% CIs) are expressed as percentages.|Dabigatran etexilate administered alone as Reference, ARV-471 coadministered with dabigatran etexilate as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||221.79|166.56|
73914476|NCT05673889|147358004|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|197.81|||||TWO_SIDED|90.0|177.32|220.66|||||The ratios (and 90% CIs) are expressed as percentages.|Dabigatran etexilate administered alone as Reference, ARV-471 coadministered with dabigatran etexilate as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||220.66|177.32|
73914477|NCT02340975|147358015|OTHER|Comparison|Mean Difference (Net)|11.1||||0.2376|TWO_SIDED|95.0|-0.7|23.0|||Fisher Exact|||||23.0|-0.7|0.2376
73914478|NCT02340975|147358015|OTHER|Comparison|Median Difference (Net)|2.8||||1|TWO_SIDED|95.0|-16.8|22.4|||Fisher Exact|||||22.4|-16.8|1.0000
73914479|NCT02228460|147358043|OTHER|||||||0.3173||||||Threshold for significance at 0.05 level.|McNemar Test|||A McNemar test was used to test the treatment effect based on paired pre-treatment and post-treatment (Week 26) frequencies of skin GL-3 score grouped into the categories (0 to \<2; 2 to 3).||||0.3173
73914480|NCT02228460|147358044|OTHER|||||||0.625||||||Threshold for significance at 0.05 level.|Wilcoxon signed rank test|||Wilcoxon signed rank test was used to assess the mean change from Baseline to Week 26 in skin GL-3 score.||||0.625
73914481|NCT03066804|147358074|SUPERIORITY||Geometric Mean Ratio|0.8362|||<|0.0001|TWO_SIDED|95.0|0.7987|0.8754|||Mixed Models Analysis|||Week 12||0.8754|0.7987|<0.0001
73914482|NCT03066804|147358075|SUPERIORITY||Mean Difference (Net)|-2.4985||||0.4164|TWO_SIDED|95.0|-8.5267|3.52297|||Mixed Models Analysis|||||3.52297|-8.5267|0.4164
73914483|NCT03066804|147358076|SUPERIORITY||Mean Difference (Net)|0.5231||||0.4791|TWO_SIDED|95.0|-0.9258|1.972|||Mixed Models Analysis|||||1.9720|-0.9258|0.4791
73914484|NCT03066804|147358077|SUPERIORITY||Odds Ratio (OR)|0.8993||||0.5294|TWO_SIDED|95.0|0.6461|1.2518|||longitudinal binary logistic regression|||||1.2518|0.6461|0.5294
73914485|NCT03066804|147358078|SUPERIORITY||Odds Ratio (OR)|1.106||||0.4938|TWO_SIDED|95.0|0.8287|1.476|||longitudinal binary logistic regression|||||1.4760|0.8287|0.4938
73914486|NCT03066804|147358079|SUPERIORITY||Odds Ratio (OR)|0.9798||||0.8314|TWO_SIDED|95.0|0.8122|1.182|||Proportional cumulative odds model|||||1.1820|0.8122|0.8314
73914487|NCT03066804|147358080|SUPERIORITY||Mean Difference (Net)|-0.157||||0.637||95.0|-0.8093|0.4953|||Mixed Models Analysis|||||0.4953|-0.8093|0.6370
73914488|NCT00740831|147358081|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|1.2|||||ONE_SIDED|97.5|-9.3||||||Newcombe-Wilson method for CI. Percentage in A minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|||-9.3|
73914489|NCT00740831|147358081|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|8.8|||||ONE_SIDED|97.5|0.4||||||Newcombe-Wilson method for CI. Percentage in B minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|||0.4|
73914490|NCT00740831|147358082|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|0.089|||||TWO_SIDED|95.0|-0.003|0.181||No p-values generated|ANCOVA|Analysis of covariance after log transformation of the data|As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals|||0.181|-0.003|
73914491|NCT00740831|147358082|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|0.049|||||TWO_SIDED|95.0|-0.043|0.14||No p-values generated|ANCOVA|Analysis of covariance after log transformation of the data|As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals|||0.14|-0.043|
73914492|NCT00740831|147358083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.3|||<|0.001|TWO_SIDED|95.0|-40.6|-14.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata||||-14.6|-40.6|<0.001
73965717|NCT03289039|147467451|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.89|TWO_SIDED|95.0|0.24|2.81|||Log Rank|||||2.81|0.24|0.89
74088399|NCT00107042|147730237|SUPERIORITY_OR_OTHER||Response Rate|87.23|||||TWO_SIDED|95.0|74.26|95.17|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."||95.17|74.26|
73859582|NCT01459653|147265304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.925||||0.001|TWO_SIDED|95.0|1.592|5.374|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode||5.374|1.592|0.001
73914493|NCT00740831|147358083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.9|||<|0.001|TWO_SIDED|95.0|-42.0|-16.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata||||-16.6|-42.0|<0.001
73914494|NCT00740831|147358084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.3|||<|0.001|TWO_SIDED|95.0|-40.6|-14.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata||||-14.6|-40.6|<0.001
74027061|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.32|1.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||1.74|1.32|
74027062|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|5.82|11.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||11.09|5.82|
73859583|NCT01459653|147265304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.572||||0.005|TWO_SIDED|95.0|1.331|4.969|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for CIN grade 4 episode||4.969|1.331|0.005
73859584|NCT01459653|147265304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.328|||<|0.001|TWO_SIDED|95.0|0.193|0.557|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode||0.557|0.193|<0.001
73859585|NCT01459653|147265305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.673|||<|0.001|TWO_SIDED|95.0|1.284|2.179|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for FN episode||2.179|1.284|<0.001
73859586|NCT01459653|147265305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.704|||<|0.001|TWO_SIDED|95.0|2.777|7.968|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for FN episode||7.968|2.777|<0.001
73859587|NCT01459653|147265305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.002|TWO_SIDED|95.0|1.342|3.574|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for FN episode||3.574|1.342|0.002
73859588|NCT01459653|147265305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.215||||0.01|TWO_SIDED|95.0|0.067|0.687|||Regression, Logistic|||History of anaemia at enrollment as patient-level predictor for FN episode||0.687|0.067|0.010
73859589|NCT01459653|147265305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.501||||0.025|TWO_SIDED|95.0|1.169|10.487|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode||10.487|1.169|0.025
73859590|NCT01459653|147265306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.975||||0.003|TWO_SIDED|95.0|0.958|0.991|||Regression, Logistic|||Patient age (per 1 year) as patient-level predictor for FN episode||0.991|0.958|0.003
73859591|NCT01459653|147265306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.398|||<|0.001|TWO_SIDED|95.0|1.61|3.57|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for FN episode||3.570|1.610|<0.001
73859592|NCT01459653|147265306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.562||||0.001|TWO_SIDED|95.0|1.45|4.527|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for FN episode||4.527|1.450|0.001
73859593|NCT01459653|147265306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.232|||<|0.001|TWO_SIDED|95.0|0.108|0.499|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for FN episode||0.499|0.108|<0.001
73859594|NCT01459653|147265306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.261||||0.011|TWO_SIDED|95.0|1.315|8.084|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode||8.084|1.315|0.011
73859595|NCT01459653|147265307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.814|||<|0.001|TWO_SIDED|95.0|1.397|2.355|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for CIN/FN-related hospitalization||2.355|1.397|<0.001
73859596|NCT01459653|147265307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.296|||<|0.001|TWO_SIDED|95.0|1.791|6.065|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN/FN-related hospitalization||6.065|1.791|<0.001
73859597|NCT01459653|147265307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.205||||0.001|TWO_SIDED|95.0|1.38|3.524|||Regression, Logistic|||CIN1/4 in previous cycles as cycle-level predictor for CIN/FN-related hospitalization||3.524|1.380|0.001
73859598|NCT01459653|147265307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.863||||0.032|TWO_SIDED|95.0|1.054|3.293|||Regression, Logistic|||Under- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||3.293|1.054|0.032
73859599|NCT01459653|147265307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.385||||0.024|TWO_SIDED|95.0|0.168|0.879|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||0.879|0.168|0.024
73859600|NCT01459653|147265307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.843||||0.001|TWO_SIDED|95.0|1.964|11.942|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization||11.942|1.964|0.001
73859601|NCT01459653|147265308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.473|||<|0.001|TWO_SIDED|95.0|1.55|3.946|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for CIN/FN-related hospitalization||3.946|1.550|<0.001
73859602|NCT01459653|147265308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.382||||0.002|TWO_SIDED|95.0|0.21|0.695|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||0.695|0.210|0.002
73859603|NCT01459653|147265308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.108||||0.001|TWO_SIDED|95.0|1.56|6.192|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization||6.192|1.560|0.001
73859604|NCT01459653|147265309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.931|||<|0.001|TWO_SIDED|95.0|5.426|14.699|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN/FN-related chemotherapy disturbance||14.699|5.426|<0.001
74085792|NCT05966090|147725733|NON_INFERIORITY|Non - Inferiority (NI) was to be demonstrated if the upper limit of the 2 sided 95% confidence interval (CI) of the GMC ratio between the Control group (at Day 91) versus Co-administration group (at Day 91) for anti-gE Ab 1-month after the second HZ/su vaccine dose was \<=1.5.|Ratio|1.24|||||TWO_SIDED|95.0|1.08|1.42|||||The analysis of covariance (ANCOVA) model, for logarithm-transformed concentration, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate non-inferiority of the humoral immune response to 2 doses of HZ/su vaccine when the first dose of HZ/su vaccine was co-administered with RSVPreF3 OA investigational vaccine, compared to 2 doses of HZ/su vaccine administered alone.||1.42|1.08|
74085793|NCT05966090|147725734|NON_INFERIORITY|NI was to be demonstrated if upper limit of the 2 sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-A neutralizing titer 1-month after the RSVPreF3 OA investigational vaccine dose was \<=1.5|ratio|1.14|||||TWO_SIDED|95.0|0.97|1.35|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine when co-administered with the first dose of HZ/su vaccine, compared to RSVPreF3 OA investigational vaccine administered alone.||1.35|0.97|
74085794|NCT05966090|147725735|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2 sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-B neutralizing titer 1-month after the RSVPreF3 OA investigational vaccine dose was \<=1.5.|ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine when co-administered with the first dose of HZ/su vaccine, compared to RSVPreF3 OA investigational vaccine administered alone.||1.15|0.84|
73859605|NCT01459653|147265309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.336||||0.007|TWO_SIDED|95.0|0.152|0.74|||Regression, Logistic|||Hematological cancer (vs. oncologic) as patient-level predictor for CIN/FN-related chemotherapy disturbance||0.740|0.152|0.007
74027063|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.9|||||TWO_SIDED|95.0|4.25|8.21|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.21|4.25|
73859606|NCT01459653|147265309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.006|TWO_SIDED|95.0|0.999|1.0|||Regression, Logistic|||Cancer patients seen in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance||1.000|0.999|0.006
73859607|NCT01459653|147265309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.001|||<|0.001|TWO_SIDED|95.0|1.0|1.001|||Regression, Logistic|||Chemotherapy-treated cancer patients in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance||1.001|1.000|<0.001
73859608|NCT01459653|147265309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.456||||0.024|TWO_SIDED|95.0|1.127|5.353|||Regression, Logistic|||Center type: academic vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance||5.353|1.127|0.024
73859609|NCT01459653|147265309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.344||||0.01|TWO_SIDED|95.0|1.342|8.331|||Regression, Logistic|||Center type: academic-affiliated vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance||8.331|1.342|0.010
73859610|NCT01459653|147265310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.965||||0.006|TWO_SIDED|95.0|1.218|3.172|||Regression, Logistic|||Female gender as patient-level predictor for CIN/FN-related chemotherapy disturbance||3.172|1.218|0.006
73859611|NCT01459653|147265310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.594||||0.001|TWO_SIDED|95.0|1.469|4.581|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for CIN/FN-related chemotherapy disturbance||4.581|1.469|0.001
73859612|NCT01459653|147265311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.002|TWO_SIDED|95.0|0.424|0.821|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.821|0.424|0.002
73859613|NCT01459653|147265311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.644||||0.003|TWO_SIDED|95.0|0.489|0.859|||Regression, Logistic|||Zarzio duration: 4-5 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.859|0.489|0.003
73859614|NCT01459653|147265311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.004|TWO_SIDED|95.0|0.398|0.842|||Regression, Logistic|||Zarzio duration: 1-3 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.842|0.398|0.004
73859615|NCT01459653|147265311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.369||||0.001|TWO_SIDED|95.0|1.14|1.643|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||1.643|1.140|0.001
73859616|NCT01459653|147265311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.499|||<|0.001|TWO_SIDED|95.0|2.456|4.985|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||4.985|2.456|<0.001
74027064|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.9|||||TWO_SIDED|95.0|3.96|6.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.00|3.96|
74027065|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.58|3.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.79|2.58|
74027066|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.9|||||TWO_SIDED|95.0|8.56|16.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.49|8.56|
73914495|NCT00740831|147358084|SUPERIORITY_OR_OTHER||Median Difference (Net)|-29.9|||<|0.001|TWO_SIDED|95.0|-42.0|-16.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata||||-16.6|-42.0|<0.001
73914496|NCT03982368|147358090|SUPERIORITY||least square mean difference|0.93||||0.078|TWO_SIDED|95.0|-1.47|3.32|||ANOVA|||The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||3.32|-1.47|0.078
73914497|NCT03982368|147358090|SUPERIORITY||least square mean difference|2.31||||0.066|TWO_SIDED|95.0|-0.08|4.7|||ANOVA|||The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||4.70|-0.08|0.066
73914498|NCT03982368|147358091|SUPERIORITY||Least square mean difference|1.71||||0.032|TWO_SIDED|95.0|-0.7|4.12|||ANOVA|||||4.12|-0.70|0.032
73914499|NCT03982368|147358091|SUPERIORITY||Least square mean difference|2.44||||0.029|TWO_SIDED|95.0|0.02|4.86|||ANOVA|||||4.86|0.02|0.029
73914500|NCT03982368|147358092|SUPERIORITY|||||||0.534|||||||t-test, 2 sided|||||||0.534
73914501|NCT03982368|147358092|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
73914502|NCT03982368|147358093|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||||||0.486
73914503|NCT03982368|147358093|SUPERIORITY|||||||0.564|||||||t-test, 2 sided|||||||0.564
73914504|NCT03982368|147358095|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.810
73914505|NCT03982368|147358095|SUPERIORITY|||||||0.733|||||||t-test, 2 sided|||||||0.733
73914506|NCT03982368|147358096|SUPERIORITY||Least square mean difference|1.97||||0.025|TWO_SIDED|95.0|-0.19|4.13|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||4.13|-0.19|0.025
73914507|NCT03982368|147358096|SUPERIORITY||Least square mean difference|0.68||||0.243|TWO_SIDED|95.0|-1.48|2.83|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||2.83|-1.48|0.243
73914508|NCT03982368|147358097|SUPERIORITY||Least square mean difference|2.41||||0.007|TWO_SIDED|95.0|0.28|4.54|||ANOVA|||||4.54|0.28|0.007
74085795|NCT00337428|147725749|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73914509|NCT03982368|147358097|SUPERIORITY||Least square mean difference|0.71||||0.23|TWO_SIDED|95.0|-1.43|2.85|||ANOVA|||||2.85|-1.43|0.230
73914510|NCT03982368|147358098|SUPERIORITY||Least square mean difference|-1.16||||0.799|TWO_SIDED|95.0|-3.11|0.8|||ANOVA|Last Observation Carried Forward (LOCF) was used for imputing missing data in the Full analysis set at Week 4.||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||0.80|-3.11|0.799
73914511|NCT03982368|147358098|SUPERIORITY||Least square mean difference|-0.36||||0.715|TWO_SIDED|95.0|-2.3|1.59|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||1.59|-2.30|0.715
73914512|NCT03982368|147358099|SUPERIORITY||Least square mean difference|-1.54||||0.831|TWO_SIDED|95.0|-3.4|0.31|||ANOVA|||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||0.31|-3.40|0.831
73914513|NCT03982368|147358099|SUPERIORITY||Least square mean difference|-0.21||||0.75|TWO_SIDED|95.0|-2.07|1.66|||ANOVA|||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||1.66|-2.07|0.750
73914514|NCT03982368|147358100|SUPERIORITY||Least square mean difference|0.96||||0.004|TWO_SIDED|95.0|0.17|1.75|||ANOVA|||||1.75|0.17|0.004
73914515|NCT03982368|147358100|SUPERIORITY||Least square mean difference|0.28||||0.217|TWO_SIDED|95.0|-0.51|1.07|||ANOVA|||||1.07|-0.51|0.217
73914516|NCT03982368|147358101|SUPERIORITY||Least square mean difference|0.92||||0.007|TWO_SIDED|95.0|0.1|1.74|||ANOVA|||||1.74|0.10|0.007
73914517|NCT03982368|147358101|SUPERIORITY||Least square mean difference|0.28||||0.225|TWO_SIDED|95.0|-0.54|1.1|||ANOVA|||||1.10|-0.54|0.225
73914518|NCT03982368|147358102|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.680
73914519|NCT03982368|147358102|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||0.066
73914520|NCT03982368|147358103|SUPERIORITY|||||||0.097|||||||Chi-squared|||||||0.097
73914521|NCT03982368|147358103|SUPERIORITY|||||||0.076|||||||Chi-squared|||||||0.076
73914522|NCT03982368|147358104|SUPERIORITY||Least square mean difference|16.4||||0.289|TWO_SIDED|95.0|12.0|20.8|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||20.8|12.0|0.289
73914523|NCT03982368|147358104|SUPERIORITY||Least square mean difference|19.7||||0.032|TWO_SIDED|95.0|15.4|24.0|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||24.0|15.4|0.032
73914524|NCT03982368|147358104|SUPERIORITY||Least square mean difference|16.4||||0.095|TWO_SIDED|95.0|11.9|20.8|||ANOVA|||Daily Activity Limitations - change to baseline to week 8||20.8|11.9|0.095
73914525|NCT03982368|147358104|SUPERIORITY||Least square mean difference|14.5||||0.282|TWO_SIDED|95.0|10.1|18.8|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||18.8|10.1|0.282
73914526|NCT03982368|147358104|SUPERIORITY||Least square mean difference|15.0||||0.169|TWO_SIDED|95.0|10.6|19.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||19.4|10.6|0.169
73914527|NCT03982368|147358104|SUPERIORITY||Least square mean difference|15.4||||0.129|TWO_SIDED|95.0|11.1|19.7|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||19.7|11.1|0.129
73965718|NCT04732494|147467454|SUPERIORITY|The primary endpoint ORR was tested at a 2-sided alpha of 0.05.|Risk Difference (RD)|9.9||||0.2114|TWO_SIDED|95.0|-5.4|25.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|||25.3|-5.4|0.2114
73965719|NCT04732494|147467455|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.58|1.45|||||Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.45|0.58|
73965720|NCT04732494|147467456|OTHER||Risk Difference (RD)|6.6|||||TWO_SIDED|95.0|-9.2|22.5|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|||22.5|-9.2|
74085796|NCT00337428|147725750|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
74085797|NCT00337428|147725751|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73859617|NCT01459653|147265311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.064|||<|0.001|TWO_SIDED|95.0|3.096|5.336|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||5.336|3.096|<0.001
73859618|NCT01459653|147265311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.545||||0.002|TWO_SIDED|95.0|1.175|2.033|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.033|1.175|0.002
73859619|NCT01459653|147265311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.596||||0.017|TWO_SIDED|95.0|1.088|2.34|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.340|1.088|0.017
73859620|NCT01459653|147265312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.621||||0.006|TWO_SIDED|95.0|1.152|2.281|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.281|1.152|0.006
73859621|NCT01459653|147265312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.898||||0.005|TWO_SIDED|95.0|1.209|2.979|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.979|1.209|0.005
73859622|NCT01459653|147265312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.016|TWO_SIDED|95.0|1.2|5.984|||Regression, Logistic|||History of repeated infections at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||5.984|1.200|0.016
73859623|NCT01459653|147265312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.438|||<|0.001|TWO_SIDED|95.0|0.291|0.66|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.660|0.291|<0.001
73859624|NCT01459653|147265312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.053||||0.002|TWO_SIDED|95.0|1.295|3.256|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||3.256|1.295|0.002
73859625|NCT01459653|147265312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.558||||0.028|TWO_SIDED|95.0|0.332|0.939|||Regression, Logistic|||GIS at enrollment (1 vs. 0) as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.939|0.332|0.028
73859626|NCT01459653|147265313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2064||||0.0116|TWO_SIDED|95.0|1.1931|4.0803|||Regression, Logistic|||Patient level predictor: History of anemia at enrollment||4.0803|1.1931|0.0116
73859627|NCT01459653|147265313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3049||||0.0057|TWO_SIDED|95.0|1.2754|4.1656|||Regression, Logistic|||Liver/renal/cardiac comorbidity as patient level predictor||4.1656|1.2754|0.0057
73859628|NCT01459653|147265313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.535|||<|0.0001|TWO_SIDED|95.0|8.2159|37.4243|||Regression, Logistic|||Poor performance (ECOG \>=2) during study as patient level predictor||37.4243|8.2159|<0.0001
73859629|NCT01459653|147265317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8703|||<|0.0001|TWO_SIDED|95.0|5.9567|37.1225|||Regression, Logistic|||Female gender as patient-level predictor for cancer-related mortality||37.1225|5.9567|<0.0001
73859630|NCT01459653|147265317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8703|||<|0.0001|TWO_SIDED|95.0|5.9567|37.1225|||Regression, Logistic|||Poor performance (ECOG \>=2) during study as patient-level predictor||37.1225|5.9567|<0.0001
73859631|NCT03315104|147265416|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.174|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test|FLU-IGIV High Dose (450 mL) - Placebo|Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.174
73859632|NCT03315104|147265416|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Mean Difference (Net)|0.0||||0.572|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test||Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.572
73859633|NCT03315104|147265416|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.534|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons. two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test||Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.534
73859634|NCT03315104|147265416|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.534|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test|FLU-IGIV pooled (450 mL + 250 mL) - Placebo|Pairwise Wilcoxon rank-sum test for a location shift where the two active dose groups were pooled and compared to placebo.||1.000|0.000|0.534
73914528|NCT03982368|147358104|SUPERIORITY||Least square mean difference|14.0||||0.111|TWO_SIDED|95.0|9.7|18.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.4|9.7|0.111
73859635|NCT00445848|147265417|OTHER||proportion of participants|0.78|||||TWO_SIDED|95.0|0.67|0.85||||||The overall survival rate at year 1 was estimated using Kaplan-Meier.||0.85|0.67|
73859636|NCT00445848|147265417|OTHER||proportion of participants|0.57|||||TWO_SIDED|95.0|0.46|0.67||||||The overall survival rate at year 2 was estimated using Kaplan-Meier.||0.67|0.46|
73859637|NCT00445848|147265417|OTHER||proportion of participants|0.43|||||TWO_SIDED|95.0|0.32|0.53||||||The overall survival rate at year 3 was estimated using Kaplan-Meier.||0.53|0.32|
73859638|NCT03199053|147265436|SUPERIORITY||Adjusted mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.274|<|0.001|TWO_SIDED|95.0|-1.57|-0.49|||ANCOVA|||||-0.49|-1.57|< 0.001
73914529|NCT03982368|147358104|SUPERIORITY||Least square mean difference|14.0||||0.107|TWO_SIDED|95.0|9.7|18.3|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.3|9.7|0.107
73914530|NCT03982368|147358104|SUPERIORITY||Least square mean difference|14.3||||0.827|TWO_SIDED|95.0|9.7|18.9|||ANOVA|||Emotional Well-Being - change from baseline to week 4||18.9|9.7|0.827
73859639|NCT03199053|147265437|SUPERIORITY||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.251||0.078|TWO_SIDED|95.0|-0.93|0.05|||ANCOVA|||||0.05|-0.93|0.078
73859640|NCT03199053|147265438|SUPERIORITY||Adjusted mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.3||0.004|TWO_SIDED|95.0|-1.44|-0.27|||ANCOVA|||||-0.27|-1.44|0.004
73859641|NCT03199053|147265439|SUPERIORITY||Adjusted mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.277||0.067|TWO_SIDED|95.0|-1.05|0.04|||ANCOVA|||||0.04|-1.05|0.067
73859642|NCT03199053|147265440|SUPERIORITY||Adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.76|-0.62|||ANCOVA|||||-0.62|-1.76|< 0.001
73914531|NCT03982368|147358104|SUPERIORITY||Least square mean difference|16.3||||0.688|TWO_SIDED|95.0|11.8|20.8|||ANOVA|||Emotional Well-Being - change from baseline to week 4||20.8|11.8|0.688
73914532|NCT03982368|147358104|SUPERIORITY||Least square mean difference|15.7||||0.324|TWO_SIDED|95.0|11.4|20.0|||ANOVA|||Emotional Well-Being - change from baseline to week 8||20.0|11.4|0.324
73859643|NCT03199053|147265441|SUPERIORITY||Adjusted mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.146|TWO_SIDED|95.0|-0.92|0.14|||ANCOVA|||||0.14|-0.92|0.146
73859644|NCT03199053|147265442|SUPERIORITY||Adjusted mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.479||0.024|TWO_SIDED|95.0|-2.02|-0.14|||ANCOVA|||||-0.14|-2.02|0.024
73859645|NCT03199053|147265443|SUPERIORITY||Adjusted mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.528||0.833|TWO_SIDED|95.0|-1.15|0.92|||ANCOVA|||||0.92|-1.15|0.833
73914533|NCT03982368|147358104|SUPERIORITY||Least square mean difference|12.9||||0.949|TWO_SIDED|95.0|8.7|17.1|||ANOVA|||Emotional Well-Being - change from baseline to week 8||17.1|8.7|0.949
73914534|NCT03982368|147358104|SUPERIORITY||Least square mean difference|15.7||||0.927|TWO_SIDED|95.0|11.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 12||20.1|11.4|0.927
73914535|NCT03982368|147358104|SUPERIORITY||Least square mean difference|14.8||||0.776|TWO_SIDED|95.0|10.8|18.8|||ANOVA|||Emotional Well-Being - change from baseline to week 12||18.8|10.8|0.776
73914536|NCT03982368|147358104|SUPERIORITY||Least square mean difference|15.7||||0.418|TWO_SIDED|95.0|11.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 16||20.1|11.4|0.418
73914537|NCT03982368|147358104|SUPERIORITY||Least square mean difference|14.8||||0.613|TWO_SIDED|95.0|10.6|19.0|||ANOVA|||Emotional Well-Being - change from baseline to week 16||19.0|10.6|0.613
73965721|NCT04732494|147467457|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.64|1.59|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.59|0.64|
73965722|NCT04732494|147467458|OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.71|1.61|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.61|0.71|
73965723|NCT04732494|147467461|OTHER||Risk Difference (RD)|2.7|||||TWO_SIDED|95.0|-14.4|19.9|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Disease Control Rate Assessed by the Investigator||19.9|-14.4|
73965724|NCT04732494|147467461|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-11.7|21.8|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Disease Control Rate Assessed by the Independent Review Committee||21.8|-11.7|
73965725|NCT04732494|147467462|OTHER||Risk Difference (RD)|3.9|||||TWO_SIDED|95.0|-12.7|20.4|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Clinical Benefit Rate Assessed by the Investigator||20.4|-12.7|
73965726|NCT04732494|147467462|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-11.0|21.0|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Clinical Benefit Rate Assessed by the Independent Review Committee||21.0|-11.0|
73965727|NCT04732494|147467463|OTHER||Least Squares (LS) Mean Difference|1.8|||||TWO_SIDED|95.0|-8.4|11.9||||||Analysis of Change from Baseline in Global Health Status/QoL at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.9|-8.4|
73965728|NCT04732494|147467463|OTHER||LS Mean Difference|3.1|||||TWO_SIDED|95.0|-5.0|11.2||||||Analysis of Change from Baseline in Global Health Status/QoL at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.2|-5.0|
73965729|NCT04732494|147467463|SUPERIORITY||LS Mean Difference|-1.7|||||TWO_SIDED|95.0|-7.1|3.7||||||Analysis of Change from Baseline in Physical Functioning at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||3.7|-7.1|
74027067|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.5|||||TWO_SIDED|95.0|2.59|4.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.76|2.59|
74027068|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.5|||||TWO_SIDED|95.0|4.61|9.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.03|4.61|
74027069|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.32|4.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.24|2.32|
74027070|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.4|||||TWO_SIDED|95.0|5.23|10.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.33|5.23|
74085798|NCT00337428|147725752|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
74085799|NCT00337428|147725753|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
74085800|NCT00337428|147725754|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
73859646|NCT03199053|147265444|SUPERIORITY||Adjusted mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.525||0.047|TWO_SIDED|95.0|-2.07|-0.01|||ANCOVA|||||-0.01|-2.07|0.047
73859647|NCT03199053|147265445|SUPERIORITY||Adjusted mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.49||0.268|TWO_SIDED|95.0|-1.5|0.42|||ANCOVA|||||0.42|-1.50|0.268
73859648|NCT03199053|147265446|SUPERIORITY||Adjusted mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.505||0.026|TWO_SIDED|95.0|-2.11|-0.13|||ANCOVA|||||-0.13|-2.11|0.026
73859649|NCT03199053|147265447|SUPERIORITY||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.618||0.644|TWO_SIDED|95.0|-0.92|1.5|||ANCOVA|||||1.50|-0.92|0.644
73859650|NCT03199053|147265448|SUPERIORITY||Adjusted Odds Ratio|3.8||||0.019|TWO_SIDED|95.0|1.2|11.7|||Regression, Logistic|||||11.7|1.2|0.019
73859651|NCT03199053|147265448|SUPERIORITY||Adjusted Odds Ratio|2.6||||0.114|TWO_SIDED|95.0|0.8|8.6|||Regression, Logistic|||||8.6|0.8|0.114
73859652|NCT03199053|147265449|SUPERIORITY||Adjusted Odds Ratio|3.5||||0.042|TWO_SIDED|95.0|1.0|11.4|||Weighted Logistic Regression|||||11.4|1.0|0.042
73859653|NCT03199053|147265449|SUPERIORITY||Adjusted Odds Ratio|2.3||||0.175|TWO_SIDED|95.0|0.7|7.4|||Weighted Logistic Regression|||||7.4|0.7|0.175
73859654|NCT03199053|147265450|SUPERIORITY||Adjusted Odds Ratio|4.4||||0.009|TWO_SIDED|95.0|1.4|13.2|||Weighted Logistic Regression|||||13.2|1.4|0.009
73859655|NCT03199053|147265450|SUPERIORITY||Adjusted Odds Ratio|3.8||||0.042|TWO_SIDED|95.0|1.1|13.5|||Weighted Logistic Regression|||||13.5|1.1|0.042
73859656|NCT03199053|147265451|SUPERIORITY||Adjusted mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.496||0.955|TWO_SIDED|95.0|-1.0|0.94|||ANCOVA|||||0.94|-1.00|0.955
73859657|NCT03199053|147265451|SUPERIORITY||Adjusted mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.495||0.64|TWO_SIDED|95.0|-1.2|0.74|||ANCOVA|||||0.74|-1.20|0.640
73859658|NCT03199053|147265452|SUPERIORITY||Adjusted mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.896||0.476|TWO_SIDED|95.0|-2.39|1.12|||ANCOVA|||||1.12|-2.39|0.476
73859659|NCT03199053|147265452|SUPERIORITY||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|1.017||0.075|TWO_SIDED|95.0|-3.81|0.18|||ANCOVA|||||0.18|-3.81|0.075
73859660|NCT03199053|147265453|SUPERIORITY||Unadjusted Difference in Percentage|-19.7||||0.182|TWO_SIDED|95.0|-44.5|5.7|||Fisher Exact|||||5.7|-44.5|0.182
73859661|NCT03199053|147265454|SUPERIORITY||Unadjusted Difference in Percentage|-6.3||||0.65|TWO_SIDED|95.0|-29.8|16.5|||Fisher Exact|||||16.5|-29.8|0.650
73859662|NCT01323270|147265471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.6|1.5||||||Diphtheria: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.5|-1.6|
73859663|NCT01323270|147265471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Tetanus: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
73859664|NCT01323270|147265471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|-1.3|||||TWO_SIDED|95.0|-4.7|1.9||||||Pertussis toxoid: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.9|-4.7|
73859665|NCT01323270|147265471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Pertussis filamentous hemagglutinin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
74027071|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.6|||||TWO_SIDED|95.0|4.07|7.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||7.69|4.07|
74027072|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.6|||||TWO_SIDED|95.0|2.5|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.20|2.50|
73914538|NCT03982368|147358104|SUPERIORITY||Least square mean difference|15.8||||0.721|TWO_SIDED|95.0|8.3|23.2|||ANOVA|||Work Limitations - change from baseline to week 4||23.2|8.3|0.721
73914539|NCT03982368|147358104|SUPERIORITY||Least square mean difference|20.6||||0.558|TWO_SIDED|95.0|13.1|28.0|||ANOVA|||Work Limitations - change from baseline to week 4||28.0|13.1|0.558
73914540|NCT03982368|147358104|SUPERIORITY||Least square mean difference|18.4||||0.809|TWO_SIDED|95.0|11.5|25.3|||ANOVA|||Work Limitations - change from baseline to week 8||25.3|11.5|0.809
73914541|NCT03982368|147358104|SUPERIORITY||Least square mean difference|19.4||||0.651|TWO_SIDED|95.0|12.4|26.4|||ANOVA|||Work Limitations - change from baseline to week 8||26.4|12.4|0.651
73914542|NCT03982368|147358104|SUPERIORITY||Least square mean difference|16.4||||0.769|TWO_SIDED|95.0|9.5|23.3|||ANOVA|||Work Limitations - change from baseline to week 12||23.3|9.5|0.769
74085801|NCT00337428|147725755|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
73914543|NCT03982368|147358104|SUPERIORITY||Least square mean difference|21.3||||0.454|TWO_SIDED|95.0|14.3|28.3|||ANOVA|||Work Limitations - change from baseline to week 12||28.3|14.3|0.454
73914544|NCT03982368|147358104|SUPERIORITY||Least square mean difference|18.3||||0.564|TWO_SIDED|95.0|11.6|25.0|||ANOVA|||Work Limitations - change from baseline to week 16||25.0|11.6|0.564
73914545|NCT03982368|147358104|SUPERIORITY||Least square mean difference|21.0||||0.25|TWO_SIDED|95.0|14.1|27.8|||ANOVA|||Work Limitations - change from baseline to week 16||27.8|14.1|0.250
73914546|NCT03982368|147358104|SUPERIORITY||Least square mean difference|23.9||||0.853|TWO_SIDED|95.0|15.6|32.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||32.2|15.6|0.853
73914547|NCT03982368|147358104|SUPERIORITY||Least square mean difference|20.0||||0.393|TWO_SIDED|95.0|11.9|28.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||28.0|11.9|0.393
73914548|NCT03982368|147358104|SUPERIORITY||Least square mean difference|27.9||||0.01|TWO_SIDED|95.0|20.2|35.6|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||35.6|20.2|0.010
73914549|NCT03982368|147358104|SUPERIORITY||Least square mean difference|18.3||||0.395|TWO_SIDED|95.0|11.1|25.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||25.4|11.1|0.395
73914550|NCT03982368|147358104|SUPERIORITY||Least square mean difference|24.8||||0.068|TWO_SIDED|95.0|17.1|32.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||32.4|17.1|0.068
73914551|NCT03982368|147358104|SUPERIORITY||Least square mean difference|19.3||||0.4|TWO_SIDED|95.0|12.2|26.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||26.4|12.2|0.400
73914552|NCT03982368|147358104|SUPERIORITY||Least square mean difference|25.5||||0.021|TWO_SIDED|95.0|18.1|33.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||33.0|18.1|0.021
73965730|NCT04732494|147467463|OTHER||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-10.3|9.3||||||Analysis of Change from Baseline in Physical Functioning at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||9.3|-10.3|
74085802|NCT00337428|147725756|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
73914553|NCT03982368|147358104|SUPERIORITY||Least square mean difference|23.1||||0.056|TWO_SIDED|95.0|16.1|30.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||30.0|16.1|0.056
73914554|NCT03982368|147358104|SUPERIORITY||Least square mean difference|14.2||||0.981|TWO_SIDED|95.0|7.6|20.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||20.7|7.6|0.981
73914555|NCT03982368|147358104|SUPERIORITY||Least square mean difference|17.0||||0.525|TWO_SIDED|95.0|11.1|22.9|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||22.9|11.1|0.525
73914556|NCT03982368|147358104|SUPERIORITY||Least square mean difference|9.5||||0.356|TWO_SIDED|95.0|2.9|16.0|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||16.0|2.9|0.356
73914557|NCT03982368|147358104|SUPERIORITY||Least square mean difference|6.5||||0.771|TWO_SIDED|95.0|0.7|12.4|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||12.4|0.7|0.771
73914558|NCT03982368|147358104|SUPERIORITY||Least square mean difference|8.7||||0.926|TWO_SIDED|95.0|2.0|15.5|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||15.5|2.0|0.926
73914559|NCT03982368|147358104|SUPERIORITY||Least square mean difference|7.9||||0.778|TWO_SIDED|95.0|1.9|13.9|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||13.9|1.9|0.778
73914560|NCT03982368|147358104|SUPERIORITY||Least square mean difference|10.0||||0.984|TWO_SIDED||||||ANOVA|||Treatment-Related Bother - change from baseline to week 16||||0.984
73914561|NCT03982368|147358104|SUPERIORITY||Least square mean difference|7.4||||0.514|TWO_SIDED|95.0|1.6|13.1|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||13.1|1.6|0.514
73914562|NCT03982368|147358104|SUPERIORITY||Least square mean difference|-16.6||||0.985|TWO_SIDED|95.0|-20.4|-12.8|||ANOVA|||Symptom Bother - change from baseline to week 4||-12.8|-20.4|0.985
73914563|NCT03982368|147358104|SUPERIORITY||Least square mean difference|-17.8||||0.646|TWO_SIDED|95.0|-21.5|-14.0|||ANOVA|||Symptom Bother - change from baseline to week 4||-14.0|-21.5|0.646
73914564|NCT03982368|147358104|SUPERIORITY||Least square mean difference|-20.7||||0.007|TWO_SIDED|95.0|-24.5|-16.9|||ANOVA|||Symptom Bother - change from baseline to week 8||-16.9|-24.5|0.007
73914565|NCT03982368|147358104|SUPERIORITY||Least square mean difference|-16.2||||0.305|TWO_SIDED|95.0|-19.9|-12.5|||ANOVA|||Symptom Bother - change from baseline to week 8||-12.5|-19.9|0.305
73914566|NCT03982368|147358104|SUPERIORITY||Least square mean difference|-19.0||||0.015|TWO_SIDED|95.0|-22.7|-15.4|||ANOVA|||Symptom Bother - change from baseline to week 12||-15.4|-22.7|0.015
73914567|NCT03982368|147358104|SUPERIORITY||Least square mean difference|-18.0||||0.039|TWO_SIDED|95.0|-21.5|-14.4|||ANOVA|||Symptom Bother - change from baseline to week 12||-14.4|-21.5|0.039
73914568|NCT03982368|147358104|SUPERIORITY||Least square mean difference|-19.7||||0.001|TWO_SIDED|95.0|-23.3|-16.0|||ANOVA|||||-16.0|-23.3|0.001
73965731|NCT04732494|147467464|OTHER||LS Mean Difference|-9.9|||||TWO_SIDED|95.0|-21.5|1.6||||||Analysis of Change from Baseline in Dysphagia at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||1.6|-21.5|
73965732|NCT04732494|147467464|OTHER||LS Mean Difference|-10.8|||||TWO_SIDED|95.0|-27.8|6.3||||||Analysis of Change from Baseline in Dysphagia at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||6.3|-27.8|
73965733|NCT04732494|147467464|OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-7.3|6.6||||||Analysis of Change from Baseline in Eating at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||6.6|-7.3|
73965734|NCT04732494|147467464|OTHER||LS Mean Difference|-9.4|||||TWO_SIDED|95.0|-18.5|-0.3||||||Analysis of Change from Baseline in Eating at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||-0.3|-18.5|
73914569|NCT03982368|147358104|SUPERIORITY||Least square mean difference|-18.9||||0.002|TWO_SIDED|95.0|-22.4|-15.3|||ANOVA|||Symptom Bother - change from baseline to week 16||-15.3|-22.4|0.002
73914570|NCT03982368|147358105|SUPERIORITY||Least square mean difference|16.8||||0.241|TWO_SIDED|95.0|12.2|21.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||21.4|12.2|0.241
73914571|NCT03982368|147358105|SUPERIORITY||Least square mean difference|19.7||||0.04|TWO_SIDED|95.0|15.1|24.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||24.4|15.1|0.040
73914572|NCT03982368|147358105|SUPERIORITY||Least square mean difference|16.8||||0.097|TWO_SIDED|95.0|12.3|21.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||21.4|12.3|0.097
73914573|NCT03982368|147358105|SUPERIORITY||Least square mean difference|15.3||||0.238|TWO_SIDED|95.0|10.7|19.9|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||19.9|10.7|0.238
73914574|NCT03982368|147358105|SUPERIORITY||Least square mean difference|16.5||||0.07|TWO_SIDED|95.0|12.0|20.9|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||20.9|12.0|0.070
73914575|NCT03982368|147358105|SUPERIORITY||Least square mean difference|16.7||||0.058|TWO_SIDED|95.0|12.3|21.1|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||21.1|12.3|0.058
73914576|NCT03982368|147358105|SUPERIORITY||Least square mean difference|13.7||||0.128|TWO_SIDED|95.0|9.3|18.1|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.1|9.3|0.128
73965735|NCT04732494|147467464|OTHER||LS Mean Difference|2.3|||||TWO_SIDED|95.0|-6.7|11.2||||||Analysis of Change from Baseline in Reflux at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.2|-6.7|
73965736|NCT04732494|147467464|OTHER||LS Mean Difference|-1.4|||||TWO_SIDED|95.0|-11.8|9.0||||||Analysis of Change from Baseline in Reflux at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||9.0|-11.8|
73965737|NCT04732494|147467464|OTHER||LS Mean Difference|0.7|||||TWO_SIDED|95.0|-7.0|8.5||||||Analysis of Change from Baseline in Pain at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||8.5|-7.0|
73965738|NCT04732494|147467464|OTHER||LS Mean Difference|-5.3|||||TWO_SIDED|95.0|-12.3|1.7||||||Analysis of Change from Baseline in Pain at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||1.7|-12.3|
73965739|NCT05136404|147467485|OTHER||Ratio of Geometric Least Squares Mean|1.0|||||TWO_SIDED|90.0|0.937|1.08|||Mixed Models Analysis|||||1.08|0.937|
73965740|NCT05136404|147467485|OTHER||Ratio of Geometric Least Squares Mean|1.04|||||TWO_SIDED|90.0|0.968|1.11|||Mixed Models Analysis|||||1.11|0.968|
73965741|NCT05136404|147467486|OTHER||Ratio of Geometric Least Squares Mean|0.989|||||TWO_SIDED|90.0|0.953|1.03|||Mixed Models Analysis|||||1.03|0.953|
73914577|NCT03982368|147358105|SUPERIORITY||Least square mean difference|16.0||||0.024|TWO_SIDED|95.0|11.6|20.3|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||20.3|11.6|0.024
73965742|NCT05136404|147467486|OTHER||Ratio of Geometric Least Squares Mean|1.02|||||TWO_SIDED|90.0|0.982|1.06|||Mixed Models Analysis|||||1.06|0.982|
73965743|NCT05136404|147467487|OTHER||Ratio of Geometric Least Squares Mean|1.01|||||TWO_SIDED|90.0|0.972|1.06|||Mixed Models Analysis|||||1.06|0.972|
73965744|NCT05136404|147467487|OTHER||Ratio of Geometric Least Squares Mean|1.03|||||TWO_SIDED|90.0|0.992|1.08|||Mixed Models Analysis|||||1.08|0.992|
73914578|NCT03982368|147358105|SUPERIORITY||Least square mean difference|15.2||||0.865|TWO_SIDED|95.0|10.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 4||20.1|10.4|0.865
73914579|NCT03982368|147358105|SUPERIORITY||Least square mean difference|17.3||||0.662|TWO_SIDED|95.0|12.4|22.2|||ANOVA|||Emotional Well-Being - change from baseline to week 4||22.2|12.4|0.662
73914580|NCT03982368|147358105|SUPERIORITY||Least square mean difference|16.7||||0.266|TWO_SIDED|95.0|12.2|21.1|||ANOVA|||Emotional Well-Being - change from baseline to week 8||21.1|12.2|0.266
73914581|NCT03982368|147358105|SUPERIORITY||Least square mean difference|13.9||||0.824|TWO_SIDED|95.0|9.4|18.3|||ANOVA|||Emotional Well-Being - change from baseline to week 8||18.3|9.4|0.824
73914582|NCT03982368|147358105|SUPERIORITY||Least square mean difference|14.8||||0.883|TWO_SIDED|95.0|10.6|19.0|||ANOVA|||Emotional Well-Being - change from baseline to week 12||19.0|10.6|0.883
73965745|NCT05136404|147467488|SUPERIORITY||Median Difference (Final Values)|0.0||||0.4728|TWO_SIDED|90.0|-0.5|0.0|||Sign test|||||0.00|-0.50|0.4728
73914583|NCT03982368|147358105|SUPERIORITY||Least square mean difference|16.3||||0.516|TWO_SIDED|95.0|12.1|20.4|||ANOVA|||Emotional Well-Being - change from baseline to week 12||20.4|12.1|0.516
73914584|NCT03982368|147358105|SUPERIORITY|Emotional Well-Being - change from baseline to week 16|Least square mean difference|16.5||||0.407|TWO_SIDED|95.0|12.1|21.0|||ANOVA|||Emotional Well-Being - change from baseline to week 16||21.0|12.1|0.407
73914585|NCT03982368|147358105|SUPERIORITY||Least square mean difference|16.4||||0.422|TWO_SIDED|95.0|12.0|20.9|||ANOVA|||Emotional Well-Being - change from baseline to week 16||20.9|12.0|0.422
73914586|NCT03982368|147358105|SUPERIORITY||Least square mean difference|15.9||||0.615|TWO_SIDED|95.0|8.1|23.8|||ANOVA|||Work Limitations - change from baseline to week 4||23.8|8.1|0.615
73914587|NCT03982368|147358105|SUPERIORITY||Least square mean difference|21.3||||0.626|TWO_SIDED|95.0|13.3|29.2|||ANOVA|||Work Limitations - change from baseline to week 4||29.2|13.3|0.626
73914588|NCT03982368|147358105|SUPERIORITY||Least square mean difference|18.3||||0.968|TWO_SIDED|95.0|11.1|25.6|||ANOVA|||Work Limitations - change from baseline to week 8||25.6|11.1|0.968
73914589|NCT03982368|147358105|SUPERIORITY||Least square mean difference|20.1||||0.689|TWO_SIDED|95.0|12.8|27.4|||ANOVA|||||27.4|12.8|0.689
73914590|NCT03982368|147358105|SUPERIORITY||Least square mean difference|15.6||||0.528|TWO_SIDED|95.0|8.5|22.7|||ANOVA|||Work Limitations - change from baseline to week 12||22.7|8.5|0.528
73965746|NCT05136404|147467488|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0142|TWO_SIDED|90.0|-0.5|0.0|||Sign test|||||0.00|-0.50|0.0142
73965747|NCT02713126|147467556|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.770
73914591|NCT03982368|147358105|SUPERIORITY||Least square mean difference|23.0||||0.368|TWO_SIDED|95.0|15.8|30.1|||ANOVA|||Work Limitations - change from baseline to week 12||30.1|15.8|0.368
73914592|NCT03982368|147358105|SUPERIORITY||Least square mean difference|17.7||||0.764|TWO_SIDED|95.0|10.7|24.7|||ANOVA|||Work Limitations - change from baseline to week 16||24.7|10.7|0.764
73914593|NCT03982368|147358105|SUPERIORITY||Least square mean difference|22.6||||0.184|TWO_SIDED|95.0|15.5|29.6|||ANOVA|||Work Limitations - change from baseline to week 16||29.6|15.5|0.184
73914594|NCT03982368|147358105|SUPERIORITY||Least square mean difference|25.4||||0.909|TWO_SIDED|95.0|16.5|34.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||34.2|16.5|0.909
73965748|NCT02713126|147467557|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
73965749|NCT02713126|147467558|SUPERIORITY|||||||0.538|||||||t-test, 2 sided|||||||0.538
73965750|NCT02713126|147467559|SUPERIORITY|||||||0.708|||||||t-test, 2 sided|||||||0.708
73965751|NCT02713126|147467560|SUPERIORITY|||||||0.496|||||||t-test, 2 sided|||||||0.496
73965752|NCT00100698|147467561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.0|STANDARD_ERROR_OF_MEAN|6.0||0.049|TWO_SIDED|95.0|-38.0|-0.5|||repeated measures mixed effects ANCOVA|||||-0.5|-38|0.049
73965753|NCT02376790|147467579|SUPERIORITY||Treatment Difference|13.9||||0.005|TWO_SIDED|95.0|5.8|22.0||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.||22.0|5.8|0.005
73965754|NCT02376790|147467579|SUPERIORITY||Treatment Difference|9.2||||0.029|TWO_SIDED|95.0|1.0|17.3||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.||17.3|1.0|0.029
74027073|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.9|||||TWO_SIDED|95.0|2.1|4.04|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.04|2.10|
73914595|NCT03982368|147358105|SUPERIORITY||Least square mean difference|21.1||||0.428|TWO_SIDED|95.0|12.2|30.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||30.0|12.2|0.428
73914596|NCT03982368|147358105|SUPERIORITY||Least square mean difference|29.8||||0.008|TWO_SIDED|95.0|21.6|37.9|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||37.9|21.6|0.008
73914597|NCT03982368|147358105|SUPERIORITY||Least square mean difference|21.3||||0.222|TWO_SIDED|95.0|13.5|29.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||29.2|13.5|0.222
73914598|NCT03982368|147358105|SUPERIORITY||Least square mean difference|25.3||||0.082|TWO_SIDED|95.0|17.2|33.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||33.4|17.2|0.082
73914599|NCT03982368|147358105|SUPERIORITY||Least square mean difference|23.3||||0.154|TWO_SIDED|95.0|15.6|31.1|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||31.1|15.6|0.154
73914600|NCT03982368|147358105|SUPERIORITY||Least square mean difference|25.8||||0.03|TWO_SIDED|95.0|18.0|33.6|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||33.6|18.0|0.030
73914601|NCT03982368|147358105|SUPERIORITY||Least square mean difference|24.6||||0.046|TWO_SIDED|95.0|17.1|32.1|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||32.1|17.1|0.046
73914602|NCT03982368|147358105|SUPERIORITY||Least square mean difference|15.4||||0.861|TWO_SIDED|95.0|8.6|22.2|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||22.2|8.6|0.861
73914603|NCT03982368|147358105|SUPERIORITY||Least square mean difference|15.3||||0.865|TWO_SIDED|95.0|9.0|21.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||21.7|9.0|0.865
73914604|NCT03982368|147358105|SUPERIORITY||Least square mean difference|10.5||||0.278|TWO_SIDED|95.0|3.6|17.3|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||17.3|3.6|0.278
73914605|NCT03982368|147358105|SUPERIORITY||Least square mean difference|7.2||||0.689|TWO_SIDED|95.0|0.9|13.5|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||13.5|0.9|0.689
73914606|NCT03982368|147358105|SUPERIORITY||Least square mean difference|9.1||||0.993|TWO_SIDED|95.0|2.1|16.2|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||16.2|2.1|0.993
73914607|NCT03982368|147358105|SUPERIORITY||Least square mean difference|9.2||||0.989|TWO_SIDED|95.0|2.8|15.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||15.7|2.8|0.989
73914608|NCT03982368|147358105|SUPERIORITY||Least square mean difference|10.4||||0.976|TWO_SIDED|95.0|3.7|17.0|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||17.0|3.7|0.976
73914609|NCT03982368|147358105|SUPERIORITY||Least square mean difference|9.0||||0.778|TWO_SIDED|95.0|2.9|15.1|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||15.1|2.9|0.778
73914610|NCT03982368|147358105|SUPERIORITY||Least square mean difference|-17.3||||0.964|TWO_SIDED|95.0|-21.2|-13.3|||ANOVA|||Symptom Bother - change from baseline to week 4||-13.3|-21.2|0.964
73914611|NCT03982368|147358105|SUPERIORITY||Least square mean difference|-18.7||||0.581|TWO_SIDED|95.0|-22.7|-14.7|||ANOVA|||Symptom Bother - change from baseline to week 4||-14.7|-22.7|0.581
73914612|NCT03982368|147358105|SUPERIORITY||Least square mean difference|-21.4||||0.006|TWO_SIDED|95.0|-25.2|-17.5|||ANOVA|||Symptom Bother - change from baseline to week 8||-17.5|-25.2|0.006
73914613|NCT03982368|147358105|SUPERIORITY||Least square mean difference|-17.6||||0.175|TWO_SIDED|95.0|-21.4|-13.7|||ANOVA|||Symptom Bother - change from baseline to week 8||-13.7|-21.4|0.175
73914614|NCT03982368|147358105|SUPERIORITY||Least square mean difference|-19.4||||0.016|TWO_SIDED|95.0|-23.1|-15.6|||ANOVA|||Symptom Bother - change from baseline to week 12||-15.6|-23.1|0.016
73914615|NCT03982368|147358105|SUPERIORITY||Least square mean difference|-19.8||||0.01|TWO_SIDED|95.0|-23.5|-16.1|||ANOVA|||Symptom Bother - change from baseline to week 12||-16.1|-23.5|0.010
74085803|NCT00337428|147725757|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
73859666|NCT01323270|147265471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Pertussis pertactin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
73859667|NCT01323270|147265471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|-1.2|||||TWO_SIDED|95.0|-3.6|0.8||||||Pertussis fimbrial agglutinogens types 2+3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||0.8|-3.6|
73859668|NCT01323270|147265471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 1: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
73859669|NCT01323270|147265471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 2: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
73859670|NCT01323270|147265471|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
73859671|NCT03832114|147265500|OTHER|Log Ratio to Baseline|Mean Difference (Final Values)|0.55||||0.0003|TWO_SIDED|80.0|0.46|0.65|||Mixed Model Repeated Measures (MMRM)|||||0.65|0.46|0.0003
73859672|NCT03832114|147265501|OTHER||Median Difference (Final Values)|-2.5||||0.0313|TWO_SIDED|80.0|-3.75|-0.75|||Wilcoxon (Mann-Whitney)|||||-0.75|-3.75|0.0313
73859673|NCT03832114|147265502|OTHER||Mean Difference (Final Values)|0.55||||0.0003|TWO_SIDED|80.0|0.46|0.65|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.65|0.46|0.0003
73859674|NCT03832114|147265502|OTHER||Mean Difference (Final Values)|0.79||||0.4766|TWO_SIDED|80.0|0.49|1.28|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.28|0.49|0.4766
73914616|NCT03982368|147358105|SUPERIORITY||Least square mean difference|-20.5||||0|TWO_SIDED|95.0|-24.3|-16.8|||ANOVA|||Symptom Bother - change from baseline to week 16||-16.8|-24.3|0.000
73914617|NCT03982368|147358105|SUPERIORITY||Least square mean difference|-20.8||||0|TWO_SIDED|95.0|-24.6|-17.1|||ANOVA|||Symptom Bother - change from baseline to week 16||-17.1|-24.6|0.000
73914618|NCT03982368|147358106|SUPERIORITY|||||||0.302|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.302
73914619|NCT03982368|147358106|SUPERIORITY|||||||0.224|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.224
73914620|NCT03982368|147358106|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.000
73914621|NCT03982368|147358106|SUPERIORITY|||||||0.885|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.885
73914622|NCT03982368|147358106|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||At week 12 (FUP)||||0.035
73914623|NCT03982368|147358106|SUPERIORITY|||||||0.698|||||||Wilcoxon (Mann-Whitney)|||At week 12 (FUP)||||0.698
73914624|NCT03982368|147358106|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||At week 16 (FUP)||||0.016
73914625|NCT03982368|147358106|SUPERIORITY|||||||0.706|||||||Wilcoxon (Mann-Whitney)|||At week 16 (FUP)||||0.706
73914626|NCT03982368|147358107|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.210
73914627|NCT03982368|147358107|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||at weeek 4||||0.260
73914628|NCT03982368|147358107|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||At week 8 (FUP)||||0.000
73914629|NCT03982368|147358107|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.734
73914630|NCT03982368|147358107|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||at week 12 (FUP)||||0.050
73914631|NCT03982368|147358107|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||at week 12 (FUP)||||0.985
73914632|NCT03982368|147358107|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||at week 16 (FUP)||||0.018
73914633|NCT03982368|147358107|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||at week 16 (FUP)||||0.580
73914634|NCT03982368|147358108|SUPERIORITY||Least square mean difference|1.2||||0.282|TWO_SIDED|95.0|-1.0|3.3|||ANOVA|||statistical analysis at week 4||3.3|-1.0|0.282
73914635|NCT03982368|147358108|SUPERIORITY||Least square mean difference|3.9||||0.497|TWO_SIDED|95.0|1.7|6.0|||ANOVA|||statistical analysis at week 4||6.0|1.7|0.497
73914636|NCT03982368|147358108|SUPERIORITY||Least square mean difference|2.6||||0.734|TWO_SIDED|95.0|0.5|4.8|||ANOVA|||statistical analysis at week 8||4.8|0.5|0.734
73914637|NCT03982368|147358108|SUPERIORITY||Least square mean difference|2.2||||0.963|TWO_SIDED|95.0|0.1|4.3|||ANOVA|||statistical analysis at week 8||4.3|0.1|0.963
73914638|NCT03982368|147358108|SUPERIORITY||Least square mean difference|2.7||||0.854|TWO_SIDED|95.0|0.7|4.8|||ANOVA|||statistical analysis at week 12||4.8|0.7|0.854
73914639|NCT03982368|147358108|SUPERIORITY||Least square mean difference|2.8||||0.881|TWO_SIDED|95.0|0.8|4.8|||ANOVA|||statistical analysis at week 12||4.8|0.8|0.881
73914640|NCT03982368|147358108|SUPERIORITY||Least square mean difference|3.0||||0.632|TWO_SIDED|95.0|0.3|5.7|||ANOVA|||statistical analysis at week 16||5.7|0.3|0.632
73914641|NCT03982368|147358108|SUPERIORITY||Least square mean difference|4.4||||0.22|TWO_SIDED|95.0|1.7|7.0|||ANOVA|||statistical analysis at week 16||7.0|1.7|0.220
73914642|NCT03982368|147358109|SUPERIORITY||Least square mean difference|1.2||||0.296|TWO_SIDED|95.0|-0.9|3.3|||ANOVA|||statistical analysis at week 4||3.3|-0.9|0.296
73914643|NCT03982368|147358109|SUPERIORITY||Least square mean difference|3.6||||0.57|TWO_SIDED|95.0|1.5|5.7|||ANOVA|||statistical analysis at week 4||5.7|1.5|0.570
73914644|NCT03982368|147358109|SUPERIORITY||Least square mean difference|2.7||||0.754|TWO_SIDED|95.0|0.5|4.9|||ANOVA|||statistical analysis at week 8||4.9|0.5|0.754
73914645|NCT03982368|147358109|SUPERIORITY||Least square mean difference|2.3||||0.972|TWO_SIDED|95.0|0.0|4.5|||ANOVA|||statistical analysis at week 8||4.5|0.0|0.972
73914646|NCT03982368|147358109|SUPERIORITY||Least square mean difference|3.4||||0.793|TWO_SIDED|95.0|1.4|5.3|||ANOVA|||statistical analysis at week 12||5.3|1.4|0.793
73914647|NCT03982368|147358109|SUPERIORITY||Least square mean difference|3.4||||0.766|TWO_SIDED|95.0|1.5|5.3|||ANOVA|||statistical analysis at week 12||5.3|1.5|0.766
73914648|NCT03982368|147358109|SUPERIORITY||Least square mean difference|3.3||||0.458|TWO_SIDED|95.0|0.6|6.0|||ANOVA|||statistical analysis at week 16||6.0|0.6|0.458
73914649|NCT03982368|147358109|SUPERIORITY||Least square mean difference|4.6||||0.147|TWO_SIDED|95.0|2.0|7.3|||ANOVA|||statistical analysis at week 16||7.3|2.0|0.147
73914650|NCT00329238|147358110|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Hazard Ratio (HR)|1.44||||0.0137||95.0|0.78|2.64||p-value for non-inferiority. The non-inferiority margin for the hazard ratio was chosen to be 2.85.|Regression, Cox|HR within cohort estimated by Cox regr. with treatment and baseline stratific. factor. Overall HR calc. by pooling with inverse variance weighting.|HR for time to first recurrent VTE or VTE death.|||2.64|0.78|0.0137
73914651|NCT00329238|147358110|SUPERIORITY_OR_OTHER|||||||0.2424||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the hazard ratio was then compared with 1 to evaluate the superiority claim of dabigatran over warfarin.|Regression, Cox|||||||0.2424
73914652|NCT00329238|147358111|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Risk Difference (RD)|0.38|||<|0.0001||95.0|-0.5|1.25||p-value for non-inferiority. The non-inferiority margin for the risk difference was chosen to be 2.80.|Regression, Cox|Risk difference for time to first recurrent VTE/VTE death is calculated based on weighted KM estimates across the cohorts via meta-analysis approach.||||1.25|-0.50|<0.0001
73914653|NCT00329238|147358111|SUPERIORITY_OR_OTHER|||||||0.4013||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the risk difference was then compared with 0 to evaluate the superiority claim of dabigatran over warfarin.|Kaplan-Meier|||||||0.4013
73914654|NCT00329238|147358112|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.4732||95.0|0.75|1.84|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent VTE or all cause death.|||1.84|0.75|0.4732
73914655|NCT00329238|147358113|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09||||0.8876||95.0|-1.11|1.28|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent VTE or all cause death at month 18.||Dabigatran versus Warfarin||1.28|-1.11|0.8876
73914656|NCT00329238|147358114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.4548||95.0|0.64|2.71|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent symptomatic DVT|Dabigatran versus Warfarin||2.71|0.64|0.4548
73914657|NCT00329238|147358115|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.19||||0.6563||95.0|-0.63|1.0|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent symptomatic DVT at Month 18.||Dabigatran versus Warfarin||1.00|-0.63|0.6563
73914658|NCT00329238|147358116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.04||||0.1925||95.0|0.7|5.98|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to first centrally adjudicated recurrent symptomatic PE.|Dabigatran versus Warfarin||5.98|0.70|0.1925
73914659|NCT00329238|147358117|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.26||||0.3723||95.0|-0.32|0.84|||Kaplan-Meier||Risk difference for the time to first centrally adjudicated recurrent symptomatic PE at Month 18|Dabigatran versus Warfarin||0.84|-0.32|0.3723
73914660|NCT00329238|147358118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9921||95.0|0.06|16.22|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to deaths related to VTE.|Dabigatran versus Warfarin||16.22|0.06|0.9921
73859675|NCT03832114|147265502|OTHER||Mean Difference (Final Values)|0.59||||0.0002|TWO_SIDED|80.0|0.51|0.69|||Mixed Model of Repeated Measures (MMRM)|||Overall- Day 84||0.69|0.51|0.0002
73914661|NCT00329238|147358119|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.9204||95.0|-0.2|0.23|||Kaplan-Meier|Risk difference for the time to deaths related to VTE at Month 18.||Dabigatran versus Warfarin||0.23|-0.20|0.9204
73914662|NCT00329238|147358120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7405||95.0|0.47|1.72|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to all deaths|Dabigatran versus Warfarin||1.72|0.47|0.7405
73914663|NCT00329238|147358121|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.9622||95.0|-0.89|0.84|||Kaplan-Meier|Risk difference for the time to all deaths at Month 18.||Dabigatran versus Warfarin||0.84|-0.89|0.9622
73914664|NCT00329238|147358122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0577||95.0|0.27|1.02|||Regression, Cox||This is the analysis of the time to the first MBE.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.||1.02|0.27|0.0577
73914665|NCT00329238|147358122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.83|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.||0.83|0.61|<0.0001
73914666|NCT03087643|147358128|OTHER|||||||0.0492|||||||Mixed Models Analysis|||||||0.0492
73914667|NCT03087643|147358129|OTHER|||||||0.0283|||||||Mixed Models Analysis|||||||0.0283
73914668|NCT03087643|147358130|OTHER|||||||0.0321|||||||Mixed Models Analysis|||||||0.0321
73914669|NCT03087643|147358131|OTHER|||||||0.0451|||||||Mixed Models Analysis|||||||0.0451
73914670|NCT03087643|147358132|OTHER|||||||0.0476|||||||Mixed Models Analysis|||||||0.0476
73914671|NCT02083783|147358133|SUPERIORITY||Mean Difference (Final Values)|-14.68|||<|0.0001|TWO_SIDED|95.0|-17.9|11.6|||ANCOVA|||Treatment difference in SKAMP-C scores from baseline to 4 hours postdose.||11.6|-17.9|<0.0001
73914672|NCT02083783|147358134|SUPERIORITY||Mean Difference (Final Values)|38.9|||<|0.0001|TWO_SIDED|95.0|27.3|50.6|||ANCOVA|||p-value for comparison between change from baseline in placebo vs active treatment||50.6|27.3|<0.0001
73859676|NCT03832114|147265503|OTHER||Mean Difference (Final Values)|0.57||||0.0011|TWO_SIDED|80.0|0.47|0.68|||Mixed Model Repeated Measures (MMRM|||Day 84||0.68|0.47|0.0011
73914673|NCT01558271|147358173|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|||<|0.001|TWO_SIDED|95.0|-1.79|-1.35|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide greater than 99% power to demonstrate superiority of LY2189265 to placebo. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and placebo being 0.8%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.||-1.35|-1.79|<0.001
73914674|NCT01558271|147358173|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) was \<0.4%, then LY2189265 was declared non-inferior to Liraglutide. If the upper limit of the 95% CI was \<0.0%, then LY2189265 was declared superior to liraglutide.|LS Mean Difference|-0.1||||0.248|TWO_SIDED|95.0|-0.27|0.07|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide \>90% power to confirm non-inferiority of LY2189265 to liraglutide by a margin of 0.4%. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and Liraglutide being 0%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.||0.07|-0.27|0.248
73914675|NCT01558271|147358174|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.04|TWO_SIDED|95.0|-0.39|-0.01|||Mixed Models Analysis|||||-0.01|-0.39|0.040
73914676|NCT01558271|147358175|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||<0.001
73914677|NCT01558271|147358175|SUPERIORITY_OR_OTHER|||||||0.608|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.608
73914678|NCT01558271|147358175|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||<0.001
73971313|NCT03785964|147483159|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 39 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
73859677|NCT03832114|147265503|OTHER||Mean Difference (Final Values)|1.0||||0.9998|TWO_SIDED|80.0|0.75|1.33|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.33|0.75|0.9998
73859678|NCT03832114|147265503|OTHER||Mean Difference (Final Values)|0.66||||0.0016|TWO_SIDED|80.0|0.56|0.77|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||0.77|0.56|0.0016
73859679|NCT03832114|147265504|OTHER||Mean Difference (Final Values)|0.55|||<|0.0001|TWO_SIDED|80.0|0.47|0.64|||Mixed Model Repeated Measures (MRM)|||Day 84||0.64|0.47|<0.0001
73914679|NCT01558271|147358175|SUPERIORITY_OR_OTHER|||||||0.844|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.844
73914680|NCT01558271|147358175|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.112
73914681|NCT01558271|147358175|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.103
73914682|NCT01558271|147358176|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.21|||<|0.001|TWO_SIDED|95.0|-47.31|-33.11||Treatment comparison for FBG at 26 weeks between LY2189265 and placebo.|Mixed Models Analysis|||||-33.11|-47.31|<0.001
73965755|NCT02376790|147467580|SUPERIORITY||Treatment Difference|12.2||||0.005|TWO_SIDED|95.0|4.9|19.6||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.||19.6|4.9|0.005
73965756|NCT02376790|147467580|SUPERIORITY||Treatment Difference|11.6||||0.005|TWO_SIDED|95.0|4.2|18.9||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.||18.9|4.2|0.005
73965757|NCT02376790|147467582|SUPERIORITY||Treatment Difference|14.7|||<|0.001|TWO_SIDED|95.0|6.4|23.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.||23.0|6.4|<0.001
73965758|NCT02376790|147467582|SUPERIORITY||Treatment Difference|11.8||||0.006|TWO_SIDED|95.0|3.4|20.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.||20.2|3.4|0.006
74085804|NCT00337428|147725758|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
73914683|NCT01558271|147358176|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.835|TWO_SIDED|95.0|-4.82|5.96|||Mixed Models Analysis|Treatment comparison for FBG at 26 weeks between LY2189265 and Liraglutide.||||5.96|-4.82|0.835
73914684|NCT01558271|147358176|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.77||||0.553|TWO_SIDED|95.0|-7.65|4.1||Treatment comparison for FBG at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||4.10|-7.65|0.553
73914685|NCT01558271|147358178|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.057|TWO_SIDED|95.0|-0.02|1.23|||Mixed Models Analysis|Treatment comparison for body weight at 26 weeks between LY2189265 and placebo.||||1.23|-0.02|0.057
73914686|NCT01558271|147358178|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.168|TWO_SIDED|95.0|-0.14|0.82||Treatment comparison for body weight at 26 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||0.82|-0.14|0.168
73965759|NCT02376790|147467583|SUPERIORITY||Treatment Difference|13.4|||<|0.001|TWO_SIDED|95.0|6.5|20.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.||20.4|6.5|<0.001
73965760|NCT02376790|147467583|SUPERIORITY||Treatment Difference|13.7|||<|0.001|TWO_SIDED|95.0|6.7|20.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.||20.7|6.7|<0.001
73965761|NCT02376790|147467592|SUPERIORITY||LS Mean Treatment Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.91|-0.34||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24||-0.34|-0.91|<0.001
73965762|NCT02376790|147467592|SUPERIORITY||LS Mean Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.92|-0.34||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24||-0.34|-0.92|<0.001
73914687|NCT01558271|147358178|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.911|TWO_SIDED|95.0|-0.64|0.57||Treatment comparison for body weight at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||0.57|-0.64|0.911
73914688|NCT01558271|147358179|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.86||||0.723|TWO_SIDED|95.0|-12.2|8.48||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA|||||8.48|-12.20|0.723
73914689|NCT01558271|147358179|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.998|TWO_SIDED|95.0|-7.92|7.91||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||7.91|-7.92|0.998
73914690|NCT01558271|147358179|SUPERIORITY_OR_OTHER||LS Mean Difference|0.83||||0.848|TWO_SIDED|95.0|-7.72|9.38||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA|||||9.38|-7.72|0.848
73914691|NCT01558271|147358179|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.03||||0.357|TWO_SIDED|95.0|-9.48|3.42||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||3.42|-9.48|0.357
73914692|NCT01558271|147358179|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.49||||0.533|TWO_SIDED|95.0|-10.35|5.36||Treatment comparison for HOMA2-%S based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.36|-10.35|0.533
73914693|NCT01558271|147358179|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03||||0.747|TWO_SIDED|95.0|-7.32|5.25||Treatment comparison for HOMA2-%S based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.25|-7.32|0.747
73914694|NCT01558271|147358180|SUPERIORITY_OR_OTHER||LS Mean Difference|28.35|||<|0.001|TWO_SIDED|95.0|21.63|35.07||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA|||||35.07|21.63|<0.001
73914695|NCT01558271|147358180|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08||||0.242|TWO_SIDED|95.0|-2.09|8.24||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||8.24|-2.09|0.242
73914696|NCT01558271|147358180|SUPERIORITY_OR_OTHER||LS Mean Difference|24.82|||<|0.001|TWO_SIDED|95.0|19.25|30.4||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA|||||30.40|19.25|<0.001
73914697|NCT01558271|147358180|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91||||0.376|TWO_SIDED|95.0|-2.32|6.13||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||6.13|-2.32|0.376
73914698|NCT01558271|147358180|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91||||0.417|TWO_SIDED|95.0|-2.72|6.54||Treatment comparison for HOMA2-%B based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||6.54|-2.72|0.417
73914699|NCT01558271|147358180|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.753|TWO_SIDED|95.0|-3.83|5.29||Treatment comparison for HOMA2-%B based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.29|-3.83|0.753
73914700|NCT01558271|147358181|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 26 weeks between LY2189265 and placebo.|Fisher Exact|||||||>0.999
73914701|NCT01558271|147358181|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 26 weeks between LY2189265 and Liraglutide.|Fisher Exact|||||||>0.999
73914702|NCT01558271|147358181|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 52 weeks between LY2189265 and Liraglutide.|Fisher Exact|||||||>0.999
73914703|NCT02610725|147358204|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|0.81||0.013|TWO_SIDED|95.0|-3.73|-0.46|||t-test, 2 sided|51 degrees of freedom.|Means were analyzed in (pre-post) format. A negative mean here indicates an increase in positive affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes positive affect analysis.||-0.46|-3.73|0.013
73914704|NCT02610725|147358204|SUPERIORITY||Mean Difference (Final Values)|6.06|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|4.1|8.02|||t-test, 2 sided|51 degrees of freedom|Means were analyzed in a (pre-post) format. A positive mean indicates a decrease in negative affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes negative affect analysis.||8.02|4.10|<0.001
73914705|NCT00826943|147358207|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.03
73914706|NCT00826943|147358207|SUPERIORITY_OR_OTHER|||||||0.11||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.11
73914707|NCT00826943|147358207|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||.45
73914708|NCT00826943|147358208|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||The threshold for significance was p \< .05.|Wilcoxon (Mann-Whitney)|||||||.27
73914709|NCT00826943|147358208|SUPERIORITY_OR_OTHER|||||||0.8||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.8
73914710|NCT00826943|147358208|SUPERIORITY_OR_OTHER|||||||0.52||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.52
73914711|NCT00826943|147358209|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.14
73914712|NCT00826943|147358209|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||.54
73914713|NCT00826943|147358209|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||.42
73914714|NCT04249583|147358295|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
73914715|NCT01397084|147358351|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.||||<0.001
73914716|NCT05275400|147358379|NON_INFERIORITY|Noninferiority margin (NIM) was 0.4%|LS Mean Difference|-0.089|||||TWO_SIDED|95.0|-0.191|0.013||||||||0.013|-0.191|
73914717|NCT05275400|147358380|SUPERIORITY||LS Mean Difference|-0.089||||0.088|TWO_SIDED|95.0|-0.191|0.013|||ANCOVA|||||0.013|-0.191|0.088
73914718|NCT05275400|147358381|SUPERIORITY||Relative rate|1.03||||0.897|TWO_SIDED|95.0|0.62|1.74|||Negative binomial model|||||1.74|0.62|0.897
73914719|NCT05275400|147358382|SUPERIORITY||LS Mean Difference|0.42||||0.722|TWO_SIDED|95.0|-1.88|2.72|||ANCOVA|||||2.72|-1.88|0.722
73914720|NCT05275400|147358383|SUPERIORITY||LS Mean Difference|-0.84||||0.605|TWO_SIDED|95.0|-4.01|2.33|||ANCOVA|||||2.33|-4.01|0.605
73914721|NCT05275400|147358384|SUPERIORITY||LS Mean Difference|-30.0||||0.003|TWO_SIDED|95.0|-50.1|-9.97|||Mixed Models Analysis|||||-9.97|-50.10|0.003
73914722|NCT05275400|147358385|SUPERIORITY||Relative rate|1.14||||0.43|TWO_SIDED|95.0|0.83|1.56|||Negative binomial model|||||1.56|0.83|0.430
73914723|NCT05275400|147358386|SUPERIORITY||LS Mean Difference|0.071||||0.756|TWO_SIDED|95.0|-0.38|0.52|||Mixed Models Analysis|||||0.52|-0.38|0.756
73914724|NCT05275400|147358387|SUPERIORITY||LS Mean Difference|0.14||||0.021|TWO_SIDED|95.0|0.02|0.27|||ANCOVA|||||0.27|0.02|0.021
73914725|NCT05275400|147358388|SUPERIORITY||LS Mean Difference|-0.99||||0.417|TWO_SIDED|95.0|-3.37|1.4|||ANCOVA|||||1.40|-3.37|0.417
73914726|NCT05275400|147358389|SUPERIORITY||LS Mean Difference|3.15|||<|0.001|TWO_SIDED|95.0|1.71|4.59|||Mixed Models Analysis|||Week 26||4.59|1.71|<0.001
73914727|NCT05275400|147358389|SUPERIORITY||LS Mean Difference|3.56|||<|0.001|TWO_SIDED|95.0|2.05|5.07|||Mixed Models Analysis|||Week 52||5.07|2.05|<0.001
73914728|NCT05275400|147358389|SUPERIORITY||LS Mean Difference|3.35|||<|0.001|TWO_SIDED|95.0|1.75|4.94|||Mixed Models Analysis|||Week 78||4.94|1.75|<0.001
73914729|NCT02585960|147358393|SUPERIORITY||Gaussian Statistic estimate|1.96||||0.0545|TWO_SIDED|95.0|-0.038|3.958|||Chi-squared||Approximately Gaussian Statistic is obtained by taking the square root of the Chi-squared test with continuity adjustment.|The proportion of participants with an ABR of 0 during the second 6-month period on BAX 855 prophylaxis, was compared between the 2 prophylaxis arms using a chi-square test with continuity correction at a 2-sided 5% level of significance.||3.958|-0.038|0.0545
73914730|NCT03652012|147358474|SUPERIORITY||Mean Difference (Final Values)|54.2||||0.044|TWO_SIDED|95.0|1.54|106.85||As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.|ANOVA||Mean difference (Healthy Controls - MCI).|"We conducted a two-way factorial ANOVA (Group x Condition). Group has two levels: MCI and Healthy controls. Condition has two levels: active muscle contraction and rest.~As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure."||106.85|1.54|0.044
73914731|NCT03652012|147358474|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.912|TWO_SIDED|95.0|-51.87|57.47||As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.|ANOVA||Mean difference in slope of the stimulus-response curve by muscle contraction condition (Active - Rest).|"We conducted a two-way factorial ANOVA (Group x Condition). Group has two levels: MCI and Healthy controls. Condition has two levels: active muscle contraction and rest.~As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.~The results presented here reflect the main effect of Condition on the slope of the stimulus-response curve."||57.47|-51.87|0.912
73914732|NCT03652012|147358475|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.1021|TWO_SIDED|95.0|-4.33|45.54|||t-test, 2 sided|No adjustment for multiple comparisons.|Mean cortical silent period (CSP; units = milliseconds) in the CN group minus mean CSP in the MCI group. Positive values indicate a longer cortical silent period in the control group.|||45.54|-4.33|0.1021
73914733|NCT03652012|147358476|SUPERIORITY||Mean Difference (Final Values)|0.208||||0.19|TWO_SIDED|95.0|-0.113|0.529|||t-test, 2 sided|||||0.529|-0.113|0.19
73914734|NCT03652012|147358477|SUPERIORITY||Mean Difference (Net)|0.0078||||0.97|TWO_SIDED|95.0|-0.51|0.5|||t-test, 2 sided|||||0.50|-0.51|0.97
73914735|NCT00769392|147358499|OTHER|||||||0.28|||||||single factor analysis of variance|||A comparison of injection discomfort using mean pain scores for all 4 anesthesia intervention agents used in this study.||||0.28
73914736|NCT00769392|147358500|OTHER|||||||0.17|||||||single factor analysis of variance|||A comparison of discomfort of all 4 anesthesia intervention agents used in this study using mean pain scores.||||0.17
73914737|NCT02296320|147358504|SUPERIORITY||Relative risk reduction|31.9||||0.166|TWO_SIDED|90.0|-7.5|56.8|||Poisson regression with robust variance|||The key efficacy analyses were based on 5000 mg MEDI4893 and placebo. Participants who received 2000 mg MEDI4893 were summarized descriptively.||56.8|-7.5|0.166
73914738|NCT02899793|147358533|SUPERIORITY|||||||0.024|||||||Fisher Exact|||Subgroup difference in ORRs||||0.024
73914739|NCT03310021|147358537|SUPERIORITY||Hodges lehman Location shift|-65.5||||0.0275|TWO_SIDED|95.0|-78.0|-58.0|||2-sided Wilcoxon Rank Sum|||||-58.00|-78.00|0.0275
73914740|NCT03310021|147358537|SUPERIORITY||Hodges lehman Location shift|-61.0||||0.025|TWO_SIDED|95.0|-65.0|-44.0|||2-sided Wilcoxon Rank Sum|||||-44.00|-65.00|0.025
73914741|NCT03310021|147358537|SUPERIORITY||Hodges lehman Location shift|-32.5||||0.0136|TWO_SIDED|95.0|-47.0|-9.0|||2-sided Wilcoxon Rank Sum|||||-9.00|-47.00|0.0136
73914742|NCT03310021|147358537|SUPERIORITY||Hodges lehman Location shift|-36.5||||0.0136|TWO_SIDED|95.0|-62.0|-9.0|||2-sided Wilcoxon Rank Sum|||||-9.00|-62.00|0.0136
73914743|NCT03310021|147358537|SUPERIORITY||Hodges lehman Location shift|-59.0||||0.025|TWO_SIDED|95.0|-70.0|-38.0|||2-sided Wilcoxon Rank Sum|||||-38.00|-70.00|0.025
73914744|NCT03310021|147358537|SUPERIORITY||Hodges lehman Location shift|-66.0||||0.0119|TWO_SIDED|95.0|-68.0|-61.0|||2-sided Wilcoxon Rank Sum|||||-61.00|-68.00|0.0119
73914745|NCT03310021|147358537|SUPERIORITY||Hodges lehman Location shift|-15.5||||0.2667|TWO_SIDED|95.0|-38.0|17.0|||2-sided Wilcoxon Rank Sum|||||17.00|-38.00|0.2667
73914746|NCT03310021|147358537|SUPERIORITY||Hodges lehman Location shift|-68.0||||0.0238|TWO_SIDED|95.0|-74.0|-59.0|||2-sided Wilcoxon Rank Sum|||||-59.00|-74.00|0.0238
73914747|NCT03310021|147358537|SUPERIORITY||Hodges lehman Location shift|-56.5||||0.0007|TWO_SIDED|95.0|-65.0|-39.0|||2-sided Wilcoxon Rank Sum|||||-39.00|-65.00|0.0007
73914748|NCT03310021|147358537|SUPERIORITY||Hodges lehman Location shift|-35.0||||0.0121|TWO_SIDED|95.0|-53.0|-24.0|||2-sided Wilcoxon Rank Sum|||||-24.00|-53.00|0.0121
73914749|NCT03310021|147358538|SUPERIORITY||Hodges lehman Location shift|-80.0||||0.0256|TWO_SIDED|95.0|-83.0|-77.0|||2-sided Wilcoxon Rank Sum|||||-77.00|-83.00|0.0256
73914750|NCT03310021|147358538|SUPERIORITY||Hodges lehman Location shift|-79.5||||0.025|TWO_SIDED|95.0|-97.0|-67.0|||2-sided Wilcoxon Rank Sum|||||-67.00|-97.00|0.025
73914751|NCT03310021|147358538|SUPERIORITY||Hodges lehman Location shift|-37.0||||0.074|TWO_SIDED|95.0|-66.0|5.0|||2-sided Wilcoxon Rank Sum|||||5.00|-66.00|0.074
73914752|NCT03310021|147358538|SUPERIORITY||Hodges lehman Location shift|-10.5||||0.1066|TWO_SIDED|95.0|-59.0|10.0|||2-sided Wilcoxon Rank Sum|||||10.00|-59.00|0.1066
73914753|NCT03310021|147358538|SUPERIORITY||Hodges lehman Location shift|-84.0||||0.0219|TWO_SIDED|95.0|-87.0|-71.0|||2-sided Wilcoxon Rank Sum|||||-71.00|-87.00|0.0219
73914754|NCT03310021|147358538|SUPERIORITY||Hodges lehman Location shift|-78.0||||0.0262|TWO_SIDED|95.0|-83.0|-74.0|||2-sided Wilcoxon Rank Sum|||||-74.0|-83.00|0.0262
73914755|NCT03310021|147358538|SUPERIORITY||Hodges lehman Location shift|-50.0||||0.0412|TWO_SIDED|95.0|-65.0|0.0|||2-sided Wilcoxon Rank Sum|||||0.00|-65.00|0.0412
73914756|NCT03310021|147358538|SUPERIORITY||Hodges lehman Location shift|-89.5||||0.0269|TWO_SIDED|95.0|-93.0|-77.0|||2-sided Wilcoxon Rank Sum|||||-77.00|-93.00|0.0269
73914757|NCT03310021|147358538|SUPERIORITY||Hodges lehman Location shift|-84.0||||0.0026|TWO_SIDED|95.0|-86.0|-69.0|||2-sided Wilcoxon Rank Sum|||||-69.00|-86.00|0.0026
73914758|NCT03310021|147358538|SUPERIORITY||Hodges lehman Location shift|-65.0||||0.0181|TWO_SIDED|95.0|-76.0|-57.0|||2-sided Wilcoxon Rank Sum|||||-57.00|-76.00|0.0181
73914759|NCT03310021|147358539|SUPERIORITY||Hodges lehman Location shift|-81.06||||0.0282|TWO_SIDED|95.0|-92.99|-71.96|||2-sided Wilcoxon Rank Sum|||||-71.96|-92.99|0.0282
73914760|NCT03310021|147358539|SUPERIORITY||Hodges lehman Location shift|-69.15||||0.0282|TWO_SIDED|95.0|-96.91|-48.64|||2-sided Wilcoxon Rank Sum|||||-48.64|-96.91|0.0282
73914761|NCT03310021|147358539|SUPERIORITY||Hodges lehman Location shift|-57.39||||0.0085|TWO_SIDED|95.0|-72.07|-40.03|||2-sided Wilcoxon Rank Sum|||||-40.03|-72.07|0.0085
73914762|NCT03310021|147358539|SUPERIORITY||Hodges lehman Location shift|-54.96||||0.0085|TWO_SIDED|95.0|-80.42|-25.5|||2-sided Wilcoxon Rank Sum|||||-25.50|-80.42|0.0085
73914763|NCT03310021|147358539|SUPERIORITY||Hodges lehman Location shift|-100.25||||0.0282|TWO_SIDED|95.0|-133.08|-84.48|||2-sided Wilcoxon Rank Sum|||||-84.48|-133.08|0.0282
73914764|NCT03310021|147358539|SUPERIORITY||Hodges lehman Location shift|-79.87||||0.0282|TWO_SIDED|95.0|-86.36|-65.74|||2-sided Wilcoxon Rank Sum|||||-65.74|-86.36|0.0282
73914765|NCT03310021|147358539|SUPERIORITY||Hodges lehman Location shift|-65.02||||0.0085|TWO_SIDED|95.0|-89.54|-39.17|||2-sided Wilcoxon Rank Sum|||||-39.17|-89.54|0.0085
73914766|NCT03310021|147358539|SUPERIORITY||Hodges lehman Location shift|-91.29||||0.0282|TWO_SIDED|95.0|-128.88|-60.83|||2-sided Wilcoxon Rank Sum|||||-60.83|-128.88|0.0282
73914767|NCT03310021|147358539|SUPERIORITY||Hodges lehman Location shift|-81.49||||0.0034|TWO_SIDED|95.0|-91.05|-65.96|||2-sided Wilcoxon Rank Sum|||||-65.96|-91.05|0.0034
73914768|NCT03310021|147358539|SUPERIORITY||Hodges lehman Location shift|-58.47||||0.0189|TWO_SIDED|95.0|-110.86|-46.12|||2-sided Wilcoxon Rank Sum|||||-46.12|-110.86|0.0189
73914769|NCT03310021|147358540|SUPERIORITY||Hodges lehman Location shift|-59.39||||0.0282|TWO_SIDED|95.0|-66.48|-52.62|||2-sided Wilcoxon Rank Sum|||||-52.62|-66.48|0.0282
73914770|NCT03310021|147358540|SUPERIORITY||Hodges lehman Location shift|-59.26||||0.0282|TWO_SIDED|95.0|-70.34|-26.94|||2-sided Wilcoxon Rank Sum|||||-26.94|-70.34|0.0282
73914771|NCT03310021|147358540|SUPERIORITY||Hodges lehman Location shift|-36.76||||0.0085|TWO_SIDED|95.0|-46.14|-29.76|||2-sided Wilcoxon Rank Sum|||||-29.76|-46.14|0.0085
73914772|NCT03310021|147358540|SUPERIORITY||Hodges lehman Location shift|-36.82||||0.0085|TWO_SIDED|95.0|-55.81|-20.46|||2-sided Wilcoxon Rank Sum|||||-20.46|-55.81|0.0085
73914773|NCT03310021|147358540|SUPERIORITY||Hodges lehman Location shift|-61.67||||0.0282|TWO_SIDED|95.0|-75.82|-43.78|||2-sided Wilcoxon Rank Sum|||||-43.78|-75.82|0.0282
73914774|NCT03310021|147358540|SUPERIORITY||Hodges lehman Location shift|-67.63||||0.0282|TWO_SIDED|95.0|-77.4|-61.99|||2-sided Wilcoxon Rank Sum|||||-61.99|-77.40|0.0282
73914775|NCT03310021|147358540|SUPERIORITY||Hodges lehman Location shift|-40.33||||0.0085|TWO_SIDED|95.0|-59.77|-11.17|||2-sided Wilcoxon Rank Sum|||||-11.17|-59.77|0.0085
73914776|NCT03310021|147358540|SUPERIORITY||Hodges lehman Location shift|-59.18||||0.0282|TWO_SIDED|95.0|-101.02|-48.14|||2-sided Wilcoxon Rank Sum|||||-48.14|-101.02|0.0282
73914777|NCT03310021|147358540|SUPERIORITY||Hodges lehman Location shift|-54.63||||0.0027|TWO_SIDED|95.0|-59.14|-41.19|||2-sided Wilcoxon Rank Sum|||||-41.19|-59.14|0.0027
73914778|NCT03310021|147358540|SUPERIORITY||Hodges lehman Location shift|-38.14||||0.0189|TWO_SIDED|95.0|-65.78|-15.37|||2-sided Wilcoxon Rank Sum|||||-15.37|-65.78|0.0189
73914779|NCT03310021|147358541|SUPERIORITY||Hodges lehman Location shift|965.09||||0.0282|TWO_SIDED|95.0|474.48|1377.35|||2-sided Wilcoxon Rank Sum|||||1377.35|474.48|0.0282
73914780|NCT03310021|147358541|SUPERIORITY||Hodges lehman Location shift|1127.29||||0.0282|TWO_SIDED|95.0|769.46|1575.02|||2-sided Wilcoxon Rank Sum|||||1575.02|769.46|0.0282
73914781|NCT03310021|147358541|SUPERIORITY||Hodges lehman Location shift|574.89||||0.0085|TWO_SIDED|95.0|307.65|1175.28|||2-sided Wilcoxon Rank Sum|||||1175.28|307.65|0.0085
73914782|NCT03310021|147358541|SUPERIORITY||Hodges lehman Location shift|715.34||||0.0085|TWO_SIDED|95.0|535.38|836.4|||2-sided Wilcoxon Rank Sum|||||836.40|535.38|0.0085
73914783|NCT03310021|147358541|SUPERIORITY||Hodges lehman Location shift|1141.17||||0.0282|TWO_SIDED|95.0|964.03|1736.78|||2-sided Wilcoxon Rank Sum|||||1736.78|964.03|0.0282
73914784|NCT03310021|147358541|SUPERIORITY||Hodges lehman Location shift|1198.83||||0.0282|TWO_SIDED|95.0|988.82|1670.3|||2-sided Wilcoxon Rank Sum|||||1670.30|988.82|0.0282
73914785|NCT03310021|147358541|SUPERIORITY||Hodges lehman Location shift|721.21||||0.0085|TWO_SIDED|95.0|585.92|1108.92|||2-sided Wilcoxon Rank Sum|||||1108.92|585.92|0.0085
73914786|NCT03310021|147358541|SUPERIORITY||Hodges lehman Location shift|1204.62||||0.0282|TWO_SIDED|95.0|1001.72|1471.45|||2-sided Wilcoxon Rank Sum|||||1471.45|1001.72|0.0282
73914787|NCT03310021|147358541|SUPERIORITY||Hodges lehman Location shift|1180.5||||0.0027|TWO_SIDED|95.0|857.21|1296.02|||2-sided Wilcoxon Rank Sum|||||1296.02|857.21|0.0027
73914788|NCT03310021|147358541|SUPERIORITY||Hodges lehman Location shift|976.59||||0.0189|TWO_SIDED|95.0|585.99|1498.37|||2-sided Wilcoxon Rank Sum|||||1498.37|585.99|0.0189
73914789|NCT03310021|147358542|SUPERIORITY||Hodges lehman Location shift|826.9||||0.0282|TWO_SIDED|95.0|505.4|1362.11|||2-sided Wilcoxon Rank Sum|||||1362.11|505.40|0.0282
73914790|NCT03310021|147358542|SUPERIORITY||Hodges lehman Location shift|1125.7||||0.0282|TWO_SIDED|95.0|873.87|1552.77|||2-sided Wilcoxon Rank Sum|||||1552.77|873.87|0.0282
73914791|NCT03310021|147358542|SUPERIORITY||Hodges lehman Location shift|538.84||||0.0085|TWO_SIDED|95.0|291.2|1077.46|||2-sided Wilcoxon Rank Sum|||||1077.46|291.20|0.0085
73914792|NCT03310021|147358542|SUPERIORITY||Hodges lehman Location shift|687.57||||0.0085|TWO_SIDED|95.0|500.92|902.73|||2-sided Wilcoxon Rank Sum|||||902.73|500.92|0.0085
73914793|NCT03310021|147358542|SUPERIORITY||Hodges lehman Location shift|1012.45||||0.0282|TWO_SIDED|95.0|859.08|1352.05|||2-sided Wilcoxon Rank Sum|||||1352.05|859.08|0.0282
73965763|NCT02376790|147467593|SUPERIORITY||LS Mean Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.18||0.59|TWO_SIDED|95.0|-2.93|1.68||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24||1.68|-2.93|0.59
73965764|NCT02376790|147467593|SUPERIORITY||LS Mean Treatment Difference|-1.32|STANDARD_ERROR_OF_MEAN|1.18||0.26|TWO_SIDED|95.0|-3.63|0.99||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24||0.99|-3.63|0.26
74027074|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.9|||||TWO_SIDED|95.0|2.26|3.71|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.71|2.26|
74027075|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.8|||||TWO_SIDED|95.0|2.23|3.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.63|2.23|
74088400|NCT00107042|147730237|SUPERIORITY_OR_OTHER||Response Rate|94.55|||||TWO_SIDED|95.0|84.88|98.86|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the 'Twinrix arm is presented here."||98.86|84.88|
73859680|NCT03832114|147265504|OTHER||Mean Difference (Final Values)|0.61||||0.3707|TWO_SIDED|80.0|0.3|1.27|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.27|0.30|0.3707
73859681|NCT03832114|147265504|OTHER||Mean Difference (Final Values)|0.6||||0.0002|TWO_SIDED|80.0|0.51|0.71|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||0.71|0.51|0.0002
73859682|NCT03832114|147265505|OTHER||Mean Difference (Final Values)|0.57||||0.0018|TWO_SIDED|80.0|0.47|0.7|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.70|0.47|0.0018
73859683|NCT03832114|147265505|OTHER||Mean Difference (Final Values)|0.81||||0.1632|TWO_SIDED|80.0|0.67|0.98|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.98|0.67|0.1632
73859684|NCT03832114|147265505|OTHER||Mean Difference (Final Values)|0.67||||0.004|TWO_SIDED|80.0|0.57|0.79|||Mixed Model Repeated Measure (MMRM)|||Overall- Day 84||0.79|0.57|0.0040
73859685|NCT03832114|147265506|OTHER||Mean Difference (Final Values)|2.59||||0.1795|TWO_SIDED|80.0|0.12|5.06|||Mixed Model of Repeated Measures (MMRM)|||Day 84||5.06|0.12|0.1795
73859686|NCT03832114|147265506|OTHER||Mean Difference (Final Values)|-0.61||||0.7763|TWO_SIDED|0.7763|-3.36|2.15|||Mixed Model Repeated Measures (MMRM)|||Day 84||2.15|-3.36|0.7763
73859687|NCT03832114|147265506|OTHER||Mean Difference (Final Values)|1.32||||0.3754|TWO_SIDED|80.0|-0.59|3.22|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||3.22|-0.59|0.3754
73859688|NCT03832114|147265507|OTHER||Mean Difference (Final Values)|-5.04||||0.1364|TWO_SIDED|80.0|-9.36|-0.72|||Mixed Model Repeated Measuers (MMRM)|||Day 84||-0.72|-9.36|0.1364
73859689|NCT03832114|147265507|OTHER||Mean Difference (Final Values)|7.17||||0.3038|TWO_SIDED|80.0|-1.79|16.13|||Mixed Model Repeated Measures (MMRM)|||Day 84||16.13|-1.79|0.3038
73859690|NCT03832114|147265507|OTHER||Mean Difference (Final Values)|-0.77||||0.8352|TWO_SIDED|80.0|-5.56|4.01|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||4.01|-5.56|0.8352
73859691|NCT03832114|147265508|OTHER||Mean Difference (Final Values)|1.07||||0.2752|TWO_SIDED|80.0|0.99|1.17|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.17|0.99|0.2752
73859692|NCT03832114|147265508|OTHER||Mean Difference (Final Values)|1.2||||0.476|TWO_SIDED|80.0|0.83|1.72|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.72|0.83|0.476
73859693|NCT03832114|147265508|OTHER||Mean Difference (Final Values)|1.1||||0.1963|TWO_SIDED|80.0|1.0|1.2|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||1.20|1.00|0.1963
73859694|NCT03832114|147265510|OTHER||Mean Difference (Final Values)|0.56|||<|0.0001|TWO_SIDED|80.0|0.48|0.65|||Mixed Model Repeated Measures (MMRM)|||Day 64||0.65|0.48|<0.0001
73859695|NCT03832114|147265510|OTHER||Mean Difference (Final Values)|0.99||||0.9544|TWO_SIDED|80.0|0.76|1.28|||Mixed Model Repeated Measures (MMRM)|||Day 64||1.28|0.76|0.9544
73859696|NCT03832114|147265510|OTHER||Mean Difference (Final Values)|0.64|||<|0.0001|TWO_SIDED|80.0|0.56|0.72|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 64||0.72|0.56|<.0001
73859697|NCT03832114|147265511|OTHER||Mean Difference (Final Values)|0.59|||<|0.0001|TWO_SIDED|80.0|0.5|0.69|||Mixed Model Repeated Measures (MMRM)|||Day 64||0.69|0.50|<.0001
73859698|NCT03832114|147265511|OTHER||Median Difference (Final Values)|0.87||||0.6209|TWO_SIDED|80.0|0.6|1.26|||Mixed Model Repeated Measures (MMRM)|||Day 64||1.26|0.60|0.6209
73859699|NCT03832114|147265511|OTHER||Mean Difference (Final Values)|0.63||||0.0002|TWO_SIDED|80.0|0.54|0.73|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 64||0.73|0.54|0.0002
73859700|NCT01643850|147265554|SUPERIORITY||Mean Difference (Net)|0.98||||0.915|TWO_SIDED|95.0|0.71|1.36|||ANCOVA|||||1.36|0.71|0.915
73859701|NCT01643850|147265554|SUPERIORITY||Median Difference (Net)|0.78||||0.117|TWO_SIDED|95.0|0.57|1.07|||ANCOVA|||||1.07|0.57|0.117
73859702|NCT01643850|147265554|SUPERIORITY||Mean Difference (Net)|0.69||||0.01|TWO_SIDED|95.0|0.52|0.91|||ANCOVA|||||0.91|0.52|0.010
73859703|NCT03054350|147265577|SUPERIORITY||Least squares mean difference|1.19|STANDARD_ERROR_OF_MEAN|0.314||0.0004|TWO_SIDED|95.0|0.56|1.82|||ANCOVA|The analysis of covariance (ANCOVA) model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||1.82|0.56|0.0004
73859704|NCT03054350|147265577|SUPERIORITY||Least squares mean difference|1.56|STANDARD_ERROR_OF_MEAN|0.315|<|0.0001|TWO_SIDED|95.0|0.93|2.19|||ANCOVA|The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.19|0.93|<0.0001
73859705|NCT03054350|147265577|SUPERIORITY||Least squares mean difference|1.89|STANDARD_ERROR_OF_MEAN|0.326|<|0.0001|TWO_SIDED|95.0|1.23|2.54|||ANCOVA|The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.54|1.23|<0.0001
73859706|NCT03054350|147265583|SUPERIORITY||Least squares mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.122||0.0232|TWO_SIDED|95.0|0.04|0.54|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups;1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.54|0.04|0.0232
73914794|NCT03310021|147358542|SUPERIORITY||Hodges lehman Location shift|1057.27||||0.0282|TWO_SIDED|95.0|818.96|1634.3|||2-sided Wilcoxon Rank Sum|||||1634.30|818.96|0.0282
73914795|NCT03310021|147358542|SUPERIORITY||Hodges lehman Location shift|630.81||||0.0085|TWO_SIDED|95.0|421.78|1124.28|||2-sided Wilcoxon Rank Sum|||||1124.28|421.78|0.0085
73914796|NCT03310021|147358542|SUPERIORITY||Hodges lehman Location shift|925.84||||0.0282|TWO_SIDED|95.0|663.74|1216.28|||2-sided Wilcoxon Rank Sum|||||1216.28|663.74|0.0282
73914797|NCT03310021|147358542|SUPERIORITY||Hodges lehman Location shift|871.11||||0.0027|TWO_SIDED|95.0|631.67|1051.06|||2-sided Wilcoxon Rank Sum|||||1051.06|631.67|0.0027
73914798|NCT03310021|147358542|SUPERIORITY||Hodges lehman Location shift|874.44||||0.0189|TWO_SIDED|95.0|637.25|1412.21|||2-sided Wilcoxon Rank Sum|||||1412.21|637.25|0.0189
73914799|NCT00622284|147358586|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. Superiority testing was not part of the pre-specified Week 52 confirmatory analysis.|Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.04||0.0005||97.5|0.13|0.31||Due to multiple testing of the primary endpoints at weeks 52 and 104 a Bonferroni correction was applied and 97.5% confidence intervals produced. This 1-sided p-value for non-inferiority should be compared to the 1-sided threshold of 0.0125.|ANCOVA|||Linagliptin versus Glimepiride||0.31|0.13|0.0005
73914800|NCT00622284|147358587|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. However, superiority testing is only applicable if the Linagliptin decrease is greater than that in Glimepiride.|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0004||97.5|0.09|0.3||This 1-sided p-value should be compared to the 1-sided threshold of 0.0125 for non-inferiority. Due to the pre-specified hierarchial approach, further confirmatory analysis on the Week24 endpoints is only applicable if superiority is already met.|ANCOVA|||Linagliptin versus Glimepiride||0.30|0.09|0.0004
73914801|NCT00622284|147358588|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001||97.5|-2.91|-2.09||This Week52 key secondary endpoint was only to be tested (2-sided threshold of 0.025 to allow for multiple testing within a visit) if the Week52 primary hypothesis was rejected.|ANCOVA|||Linagliptin versus Glimepiride||-2.09|-2.91|<0.0001
73965765|NCT02376790|147467594|SUPERIORITY||LS Mean Treatment Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.2||0.41|TWO_SIDED|95.0|-3.35|1.38||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24||1.38|-3.35|0.41
73965766|NCT02376790|147467594|SUPERIORITY||LS Mean Treatment Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.21||0.15|TWO_SIDED|95.0|-4.09|0.65||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24||0.65|-4.09|0.15
73914802|NCT00622284|147358589|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||97.5|-3.17|-2.19||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|ANCOVA|||Linagliptin versus Glimepiride||-2.19|-3.17|<0.0001
73914803|NCT00622284|147358590|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This key secondary endpoint was only to be tested (comparing to a 2-sided threshold of 0.025) if the Week52 body weight change from baseline was confirmatory.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride||||<0.0001
73914804|NCT00622284|147358591|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride||||<0.0001
73965767|NCT02376790|147467595|SUPERIORITY||LS Mean Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.11||0.01|TWO_SIDED|95.0|-0.52|-0.07||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24||-0.07|-0.52|0.010
73965768|NCT02376790|147467595|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.62|-0.17||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24||-0.17|-0.62|<0.001
73914805|NCT00622284|147358592|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.84|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001||95.0|3.51|10.16|||ANCOVA|||Linagliptin versus Glimepiride||10.16|3.51|<0.0001
73914806|NCT00622284|147358593|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.38|STANDARD_ERROR_OF_MEAN|1.97||0.0012||95.0|2.51|10.25|||ANCOVA|||Linagliptin versus Glimepiride||10.25|2.51|0.0012
73914807|NCT00622284|147358594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.625||||0.0004||95.0|0.482|0.811|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.811|0.482|0.0004
73914808|NCT00622284|147358595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.654||||0.003||95.0|0.494|0.866|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.866|0.494|0.0030
73914809|NCT00622284|147358596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.648||||0.0025||95.0|0.489|0.859|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.859|0.489|0.0025
73914810|NCT00622284|147358597|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.689||||0.024||95.0|0.498|0.952|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.952|0.498|0.0240
73965769|NCT02376790|147467596|SUPERIORITY||LS Mean Treatment Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.34|TWO_SIDED|95.0|-0.15|0.05||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.05|-0.15|0.34
73914811|NCT00622284|147358598|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.0018||95.0|0.56|0.875|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.875|0.560|0.0018
73914812|NCT00622284|147358599|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.47|STANDARD_ERROR_OF_MEAN|5.77||0.0918||95.0|-21.07|1.59|||ANCOVA|||Linagliptin versus Glimepiride||1.59|-21.07|0.0918
73914813|NCT00418457|147358702|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.84|TWO_SIDED|95.0|0.74|1.28|||Regression, Cox|||||1.28|0.74|0.84
73914814|NCT00418457|147358703|SUPERIORITY||Odds Ratio (OR)|1.0||||0.7|TWO_SIDED|95.0|0.85|1.17|||GEE|||||1.17|0.85|0.70
73914815|NCT00418457|147358704|SUPERIORITY||Odds Ratio (OR)|0.98||||0.81|TWO_SIDED|95.0|0.75|1.28|||GEE|||||1.28|0.75|0.81
73914816|NCT00418457|147358705|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.96|TWO_SIDED|95.0|-0.63|0.6|||Mixed Models Analysis|||||0.60|-0.63|0.96
73914817|NCT00418457|147358706|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.043|TWO_SIDED|95.0|0.02|1.48|||Mixed Models Analysis|||||1.48|0.02|0.043
73914818|NCT03736447|147358709|SUPERIORITY||Risk Difference (RD)|67.2|||<|0.0001|TWO_SIDED|95.0|50.0|84.5|||Farrington-Manning test|||||84.5|50.0|<0.0001
73914819|NCT03736447|147358710|SUPERIORITY||Risk Difference (RD)|64.2|||<|0.0001|TWO_SIDED|95.0|47.0|81.4|||Farrington-Manning test|||||81.4|47.0|<0.0001
73914820|NCT03736447|147358711|SUPERIORITY||Risk Difference (RD)|56.7|||<|0.0001|TWO_SIDED|95.0|39.8|73.5|||Farrington-Manning test|||||73.5|39.8|<0.0001
73914821|NCT03547583|147358726|OTHER||Difference of LS-means|-0.52|||=|0.8008|TWO_SIDED|97.5|-5.17|4.13|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.||4.13|-5.17|= 0.8008
73914822|NCT03547583|147358726|OTHER||Difference of LS-means|-1.46|||=|0.4722|TWO_SIDED|97.5|-6.02|3.1|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.||3.10|-6.02|= 0.4722
74027076|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.1|||||TWO_SIDED|95.0|3.16|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.20|3.16|
74027077|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.5|||||TWO_SIDED|95.0|2.06|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.14|2.06|
73914823|NCT03547583|147358727|OTHER||Difference of LS-means|-1.81|||=|0.8054|TWO_SIDED|97.5|-18.3|14.67|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.||14.67|-18.30|= 0.8054
73914824|NCT03547583|147358727|OTHER||Difference of LS-means|-5.49|||=|0.4502|TWO_SIDED|97.5|-21.77|10.8|||mixed model repeated measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.||10.80|-21.77|= 0.4502
73914825|NCT01600638|147358733|OTHER||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|||||||||||||
73914826|NCT01600638|147358734|OTHER||sucess proportion|0.7823|||||TWO_SIDED|95.0|0.614|0.951||||||||0.951|0.614|
73914827|NCT02657915|147358737|SUPERIORITY||Mean Difference (Final Values)|-6.0|||=|0.165|TWO_SIDED|95.0|-14.56|2.57|||ANCOVA|||||2.57|-14.56|=0.165
73914828|NCT01703039|147358745|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
73914829|NCT01703039|147358746|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
73914830|NCT01703039|147358747|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||0.34
73914831|NCT01703039|147358748|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
73914832|NCT01703039|147358749|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
73914833|NCT02302807|147358767|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.4134|TWO_SIDED|95.0|0.63|1.21|||Log Rank|||||1.21|0.63|0.4134
73914834|NCT02302807|147358767|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.71|1.05||||||||1.05|0.71|
73914835|NCT02302807|147358767|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||||0.99|0.73|
73914836|NCT04518306|147358794|SUPERIORITY||LS Means Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.451|<|0.0001|TWO_SIDED|95.0|-10.176|-4.486||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MIANALYZE procedure|||The analysis was performed using a mixed model for repeated measures (MMRM) for estimating the difference between Triple ¼ GMRx2 and placebo at Week 4||-4.486|-10.176|<0.0001
73914837|NCT04518306|147358794|SUPERIORITY||LS Means Difference|-8.23|STANDARD_ERROR_OF_MEAN|1.57|<|0.0001|TWO_SIDED|95.0|-11.305|-5.151||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MIANALYZE procedure|||The analysis was performed using a mixed model for repeated measures (MMRM) for estimating the difference between Triple ½ GMRx2 and placebo at Week 4||-5.151|-11.305|<0.0001
73914838|NCT04518306|147358795|SUPERIORITY||LS Means Difference|-7.98|STANDARD_ERROR_OF_MEAN|1.649|<|0.0001|TWO_SIDED|95.0|-11.281|-4.681||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-4.681|-11.281|<0.0001
73914839|NCT04518306|147358795|SUPERIORITY||LS Means Difference|-9.52|STANDARD_ERROR_OF_MEAN|2.034|<|0.0001|TWO_SIDED|95.0|-13.588|5.449||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||5.449|-13.588|<0.0001
73965770|NCT02376790|147467596|SUPERIORITY||LS Mean Treatment Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.67|TWO_SIDED|95.0|-0.12|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.08|-0.12|0.67
73914840|NCT04518306|147358796|SUPERIORITY||LS Means Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.204||0.0015|TWO_SIDED|95.0|-6.413|-1.597||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-1.597|-6.413|0.0015
73914841|NCT04518306|147358796|SUPERIORITY||LS Means Difference|-4.86|STANDARD_ERROR_OF_MEAN|1.133|<|0.0001|TWO_SIDED|95.0|-7.13|-2.595||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-2.595|-7.130|<0.0001
73914842|NCT04518306|147358797|SUPERIORITY||Risk Difference (RD)|28.09||||0.0002|TWO_SIDED|95.0|11.811|42.45|||Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||42.450|11.811|0.0002
73914843|NCT04518306|147358797|SUPERIORITY||Risk Difference (RD)|33.24|||<|0.0001|TWO_SIDED|95.0|17.199|47.186|||Wald test||95% confidence intervals for risk difference utilize Newcombe estimation method|||47.186|17.199|<0.0001
73914844|NCT04518306|147358798|SUPERIORITY||Risk Difference (RD)|17.18|||<|0.0001|TWO_SIDED|95.0|6.07|26.385||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method.|Percentages were calculated from the total number of participants within the randomized set.||26.385|6.070|<0.0001
73914845|NCT04518306|147358798|SUPERIORITY||Risk Difference (RD)|27.08|||<|0.0001|TWO_SIDED|95.0|15.237|36.646||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|Percentages were calculated from the total number of participants within the randomized set||36.646|15.237|<0.0001
73914846|NCT04518306|147358799|SUPERIORITY||LS Means Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.991||0.0002|TWO_SIDED|95.0|-5.978|-2.013||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-2.013|-5.978|0.0002
73914847|NCT04518306|147358799|SUPERIORITY||LS Means Difference|-5.51|STANDARD_ERROR_OF_MEAN|0.908|<|0.0001|TWO_SIDED|95.0|-7.328|-3.694||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-3.694|-7.328|<0.0001
73965771|NCT02376790|147467597|SUPERIORITY||LS Mean Treatment Difference|1.94|STANDARD_ERROR_OF_MEAN|0.8||0.015|TWO_SIDED|95.0|0.37|3.51||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24||3.51|0.37|0.015
74027078|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.0|||||TWO_SIDED|95.0|2.46|3.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.60|2.46|
73914848|NCT04518306|147358800|SUPERIORITY||LS Means Difference|-6.79|STANDARD_ERROR_OF_MEAN|1.752||0.0003|TWO_SIDED|95.0|-10.3|-3.287||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ¼ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-3.287|-10.300|0.0003
73914849|NCT04518306|147358800|SUPERIORITY||LS Means Difference|-8.74|STANDARD_ERROR_OF_MEAN|1.829|<|0.0001|TWO_SIDED|95.0|-12.403|-5.082||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ½ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-5.082|-12.403|<0.0001
73914850|NCT04518306|147358801|SUPERIORITY||LS Means Difference|-3.86|STANDARD_ERROR_OF_MEAN|1.004||0.0003|TWO_SIDED|95.0|-5.865|-1.847||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ¼ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-1.847|-5.865|0.0003
73914851|NCT04518306|147358801|SUPERIORITY||LS Means Difference|-5.42|STANDARD_ERROR_OF_MEAN|1.245|<|0.0001|TWO_SIDED|95.0|-7.915|-2.932||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ½ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-2.932|-7.915|<0.0001
73914852|NCT04518306|147358802|SUPERIORITY||Risk Difference (RD)|35.48|||<|0.0001|TWO_SIDED|95.0|19.541|48.549||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||48.549|19.541|<0.0001
73965772|NCT02376790|147467597|SUPERIORITY||LS Mean Treatment Difference|1.71|STANDARD_ERROR_OF_MEAN|0.8||0.033|TWO_SIDED|95.0|0.13|3.28||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24||3.28|0.13|0.033
74027079|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.7|||||TWO_SIDED|95.0|2.24|3.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.15|2.24|
73965773|NCT02376790|147467597|SUPERIORITY||LS Mean Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.84||0.97|TWO_SIDED|95.0|-1.69|1.63||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24||1.63|-1.69|0.97
73965774|NCT02376790|147467597|SUPERIORITY||LS Mean Treatment Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.85||0.56|TWO_SIDED|95.0|-2.16|1.16||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24||1.16|-2.16|0.56
73914853|NCT04518306|147358802|SUPERIORITY||Risk Difference (RD)|29.97|||<|0.0001|TWO_SIDED|95.0|14.218|43.093||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||43.093|14.218|<0.0001
73914854|NCT04518306|147358803|SUPERIORITY||Risk Difference (RD)|17.21||||0.003|TWO_SIDED|95.0|3.637|28.424||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||28.424|3.637|0.0030
73914855|NCT04518306|147358803|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.0001|TWO_SIDED|95.0|8.72|33.665||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||33.665|8.720|<0.0001
73914856|NCT04518306|147358804|SUPERIORITY||Risk Difference (RD)|-1.61|||||TWO_SIDED|95.0|-9.83|2.76|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||2.760|-9.830|
73914857|NCT04518306|147358804|SUPERIORITY||Risk Difference (RD)|3.47|||||TWO_SIDED|95.0|-5.276|9.774|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.774|-5.276|
73914858|NCT04518306|147358805|SUPERIORITY||Risk Difference (RD)|-3.23|||||TWO_SIDED|95.0|-12.171|1.662|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||1.662|-12.171|
73965775|NCT02376790|147467598|SUPERIORITY||LS Mean Treatment Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|-1.03|-0.09||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||-0.09|-1.03|0.020
73965776|NCT02376790|147467598|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1|TWO_SIDED|95.0|-0.88|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.08|-0.88|0.10
73965777|NCT02376790|147467600|SUPERIORITY||LS Mean Treatment Difference|13.92|STANDARD_ERROR_OF_MEAN|33.23||0.68|TWO_SIDED|95.0|-51.52|79.36||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||79.36|-51.52|0.68
74085805|NCT00337428|147725759|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
73965778|NCT02376790|147467600|SUPERIORITY||LS Mean Treatment Difference|6.34|STANDARD_ERROR_OF_MEAN|33.05||0.85|TWO_SIDED|95.0|-58.75|71.42||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||71.42|-58.75|0.85
73965779|NCT02376790|147467601|SUPERIORITY||Treatment Difference|12.9||||0.057|TWO_SIDED|95.0|-0.4|26.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||26.2|-0.4|0.057
73965780|NCT02376790|147467601|SUPERIORITY||Treatment Difference|10.9||||0.12|TWO_SIDED|95.0|-2.5|24.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||24.4|-2.5|0.12
73965781|NCT02376790|147467602|SUPERIORITY||LS Mean Treatment Difference|0.16|STANDARD_ERROR_OF_MEAN|0.42||0.7|TWO_SIDED|95.0|-0.66|0.98||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.98|-0.66|0.70
73965782|NCT02376790|147467602|SUPERIORITY||LS Mean Treatment Difference|0.04|STANDARD_ERROR_OF_MEAN|0.42||0.93|TWO_SIDED|95.0|-0.79|0.86||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.86|-0.79|0.93
74085806|NCT00337428|147725760|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
73914859|NCT04518306|147358805|SUPERIORITY||Risk Difference (RD)|-1.53|||||TWO_SIDED|95.0|-10.585|4.049||||||||4.049|-10.585|
73914860|NCT04518306|147358806|SUPERIORITY||Risk Difference (RD)|3.54|||||TWO_SIDED|95.0|-4.115|9.352|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||9.352|-4.115|
73914861|NCT04518306|147358806|SUPERIORITY||Risk Difference (RD)|5.08|||||TWO_SIDED|95.0|-2.779|11.2||||||||11.200|-2.779|
73914862|NCT04518306|147358807|SUPERIORITY||Risk Difference (RD)|3.54|||||TWO_SIDED|95.0|-4.012|9.35|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.350|-4.012|
73914863|NCT04518306|147358807|SUPERIORITY||Risk Difference (RD)|0.84|||||TWO_SIDED|95.0|-6.364|5.278|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||5.278|-6.364|
73914864|NCT04518306|147358808|SUPERIORITY||Risk Difference (RD)|-1.22|||||TWO_SIDED|95.0|-10.928|5.573|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||5.573|-10.928|
73914865|NCT04518306|147358808|SUPERIORITY||Risk Difference (RD)|4.27|||||TWO_SIDED|95.0|1.38|9.53|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||9.53|1.38|
73914866|NCT04518306|147358809|SUPERIORITY||Risk Difference (RD)|1.95|||||TWO_SIDED|95.0|-6.492|7.954|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||7.954|-6.492|
73914867|NCT04518306|147358809|SUPERIORITY||Risk Difference (RD)|3.45|||||TWO_SIDED|95.0|-5.171|9.704|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.704|-5.171|
73914868|NCT04518306|147358810|SUPERIORITY||Risk Difference (RD)|0.88|||||TWO_SIDED|95.0|-6.324|5.548|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||5.548|-6.324|
73914869|NCT04518306|147358810|SUPERIORITY||number of participants at 95% CI|0.0|||||TWO_SIDED|95.0|0.0|3.05|||||For this particular parameter we have used number of participants at 95% CI computed from Clopper-Pearson method as no risk difference was found between the Triple ½ (GMRx2) vs placebo|||3.05|0.00|
73914870|NCT04518306|147358811|SUPERIORITY||Risk Difference (RD)|-1.59|||||TWO_SIDED|95.0|-9.684|2.778|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||2.778|-9.684|
73914871|NCT04518306|147358811|SUPERIORITY||Risk Difference (RD)|-1.59|||||TWO_SIDED|95.0|-9.684|2.59|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||2.590|-9.684|
73914872|NCT04518306|147358812|SUPERIORITY||Risk Difference (RD)|4.27|||||TWO_SIDED|95.0|-6.722|12.959|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||12.959|-6.722|
73914873|NCT04518306|147358812|SUPERIORITY||Risk Difference (RD)|3.73|||||TWO_SIDED|95.0|-7.158|12.133|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||12.133|-7.158|
73914874|NCT04518306|147358813|SUPERIORITY||Risk Difference (RD)|1.43|||||TWO_SIDED|95.0|-8.585|8.916||||||||8.916|-8.585|
74027080|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.9|||||TWO_SIDED|95.0|4.55|7.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||7.76|4.55|
74027081|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.0|||||TWO_SIDED|95.0|3.13|5.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.17|3.13|
74027082|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.9|||||TWO_SIDED|95.0|5.16|9.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.25|5.16|
74027083|NCT01025336|147607527|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.8|||||TWO_SIDED|95.0|2.24|3.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.40|2.24|
74027084|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.08|1.02|
74085807|NCT00337428|147725761|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
74085808|NCT00337428|147725762|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73914875|NCT04518306|147358813|SUPERIORITY||Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-11.077|5.161||||||||5.161|-11.077|
73914876|NCT04518306|147358814|SUPERIORITY||Risk Difference (RD)|-3.82|||<|0.0001|TWO_SIDED|95.0|-17.664|8.366|||GEE procedure|||||8.366|-17.664|<0.0001
73914877|NCT04518306|147358814|SUPERIORITY||LS Means|5.42|||<|0.0001|TWO_SIDED|95.0|-9.04|17.981|||GEE procedure|||||17.981|-9.040|<0.0001
73914878|NCT02342327|147358825|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.55|1.22||||||Hazard ratio for time to lapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes||1.22|0.55|
74027085|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|1.5|||||TWO_SIDED|95.0|1.14|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.99|1.14|
74027086|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.22|3.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.06|1.22|
74027087|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|1.7|||||TWO_SIDED|95.0|1.15|2.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.56|1.15|
74085809|NCT00337428|147725763|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
74085810|NCT00337428|147725764|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73914879|NCT02342327|147358826|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.42|1.06||||||Hazard ratio for time to relapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes||1.06|0.42|
73914880|NCT00540514|147358830|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.313||||0.005|TWO_SIDED|95.1|1.082|1.593||Statistical significance defined as P-value \< 0.049.|Chi-squared||Response rate ratio = PA/PT. A response rate ratio \> 1 favors the albumin-bound paclitaxel/carboplatin arm of the study.|The null hypothesis is that the albumin-bound paclitaxel/carboplatin regimen response rate (PA) is equal to that of the paclitaxel (Taxol)/carboplatin regimen (PT). Superiority of albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin will be established if the lower bound of the 95.1% CI of the response rate ratio is \> 1.0.||1.593|1.082|0.005
73914881|NCT00540514|147358831|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.902||||0.214|TWO_SIDED|95.1|0.767|1.06||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.060|0.767|0.214
73914882|NCT00540514|147358832|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.922||||0.271|TWO_SIDED|95.1|0.797|1.066||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.066|0.797|0.271
73965783|NCT02376790|147467603|SUPERIORITY||Treatment Difference|3.2||||0.55|TWO_SIDED|95.0|-7.3|13.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||13.7|-7.3|0.55
73965784|NCT02376790|147467603|SUPERIORITY||Treatment Difference|8.8||||0.11|TWO_SIDED|95.0|-1.9|19.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||19.4|-1.9|0.11
73965785|NCT02376790|147467604|SUPERIORITY||LS Mean Treatment Difference|9.36|STANDARD_ERROR_OF_MEAN|4.33||0.031|TWO_SIDED|95.0|0.85|17.87||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||17.87|0.85|0.031
73965786|NCT02376790|147467604|SUPERIORITY||LS Mean Treatment Difference|3.02|STANDARD_ERROR_OF_MEAN|4.33||0.49|TWO_SIDED|95.0|-5.49|11.54||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||11.54|-5.49|0.49
73965787|NCT02376790|147467605|SUPERIORITY||LS Mean Treatment Difference|15.95|STANDARD_ERROR_OF_MEAN|4.55|<|0.001|TWO_SIDED|95.0|6.99|24.9||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.||24.90|6.99|<0.001
74027088|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|2.2|||||TWO_SIDED|95.0|1.36|3.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.53|1.36|
73914883|NCT00540514|147358833|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.074||||0.239|TWO_SIDED|95.0|0.953|1.21|||Chi-squared|||||1.210|0.953|0.239
73965788|NCT02376790|147467605|SUPERIORITY||LS Mean Treatment Difference|6.97|STANDARD_ERROR_OF_MEAN|4.5||0.12|TWO_SIDED|95.0|-1.89|15.83||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.||15.83|-1.89|0.12
73965789|NCT02376790|147467610|SUPERIORITY||Treatment Difference|11.4||||0.019|TWO_SIDED|95.0|2.0|20.8||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||20.8|2.0|0.019
73965790|NCT02376790|147467610|SUPERIORITY||Treatment Difference|4.2||||0.4|TWO_SIDED|95.0|-5.6|14.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||14.0|-5.6|0.40
73965791|NCT02376790|147467611|SUPERIORITY||Treatment Difference|20.1||||0.004|TWO_SIDED|95.0|6.8|33.3||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.||33.3|6.8|0.004
73965792|NCT02376790|147467611|SUPERIORITY||Treatment Difference|17.1||||0.012|TWO_SIDED|95.0|4.0|30.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.||30.2|4.0|0.012
74027089|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.15|2.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.91|1.15|
74085811|NCT00337428|147725765|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
73914884|NCT00540514|147358834|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.901||||0.551|TWO_SIDED|95.0|0.652|1.244||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma or Non squamous cell carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.244|0.652|0.551
73914885|NCT00540514|147358837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.302||95.0|||||Univariate Cox regression|||SPARC correlation with overall survival for the overall SPARC population.||||0.302
73914886|NCT00540514|147358838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||A nonsignificant interaction P-value (ie, p-value ≥ 0.100) indicates the treatment regimen effect was consistent within a prognostic factor.|Regression, Logistic|Logistic regression model with effects for treatment regimen, prognostic factor (histology), and treatment regimen by prognostic factor interaction.||||||0.036
73914887|NCT04487730|147358855|SUPERIORITY||Mean Difference (Final Values)|0.4727||||0.6249|TWO_SIDED||||||Mixed Models Analysis|||Functional connectivity within the orbital prefrontal cortex (OFC; specifically between lateral and medial OFC), significantly changed over time.||||0.6249
73914888|NCT04487730|147358856|SUPERIORITY||Mean Difference (Final Values)|3.8176||||0.525|TWO_SIDED||||||Mixed Models Analysis|||"Mixed effects model with a fixed effect for treatment and time, as well as time by treatment interaction, and a random effect for subject level.~F value for time by treatment interaction."||||.525
73914889|NCT04487730|147358857|SUPERIORITY||Mean Difference (Final Values)|0.6503||||0.844|TWO_SIDED||||||Mixed Models Analysis|||"Mixed effects model with a fixed effect for treatment and time, as well as time by treatment interaction, and a random effect for subject level.~F value for time by treatment interaction."||||.844
73965793|NCT05450458|147467617|OTHER|This study assessed longitudinal effects within a single patient group. Statistical power was calculated using a significance level of 0.05, 80% power, and 60 patients, accounting for KOOS score variability over time. The Friedman test was applied with post hoc analyses (Conover and Bonferroni). Since treatments were not compared, no non-inferiority or equivalence margin was defined|Median Change Baseline to month 6|0.22|||<|0.001|TWO_SIDED|95.0|0.15|0.23||P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.|Friedman Test|Post hoc pairwise comparisons were adjusted using the Bonferroni method, and the a priori significance level was set at 0.05|The value represents the intra-individual median KOOS improvement from baseline to month 6 after treatment. Changes were evaluated across time points within a single cohort.|The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve KOOS function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.||0.23|0.15|<0.001
74027090|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|2.8|||||TWO_SIDED|95.0|1.8|4.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||4.44|1.80|
74027091|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|1.7|||||TWO_SIDED|95.0|0.99|2.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.96|0.99|
73914890|NCT03291808|147358873|OTHER|||||||0.35|||||||Kruskal-Wallis|||||||.35
73914891|NCT02139228|147358894|SUPERIORITY_OR_OTHER||Vaccine Group Ratios|0.53|||||TWO_SIDED|95.0|0.36|0.76|||ANOVA|||||0.76|0.36|
74085812|NCT03756883|147725766|EQUIVALENCE|The 90% Confidence Interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.|Test-to-Reference Ratio|101.8|||||TWO_SIDED|90.0|92.68|111.94||||||||111.94|92.68|
74085813|NCT03756883|147725767|EQUIVALENCE|The 90% confidence interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.|Test-to-Reference Ratio|98.09|||||TWO_SIDED|90.0|87.1|110.61||||||||110.61|87.10|
73914892|NCT02139228|147358895|SUPERIORITY_OR_OTHER||Vaccine Group Differences|-11.0|||||TWO_SIDED|95.0|-18.6|-4.2|||Clopper-Pearson|||||-4.2|-18.6|
73914893|NCT00618072|147358901|SUPERIORITY_OR_OTHER|||||||0.181|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.181
73914894|NCT00618072|147358901|SUPERIORITY_OR_OTHER|||||||0.026|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.026
73914895|NCT00618072|147358901|SUPERIORITY_OR_OTHER|||||||0.063|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.063
73914896|NCT00618072|147358902|SUPERIORITY_OR_OTHER|||||||0.049|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.049
73914897|NCT00618072|147358902|SUPERIORITY_OR_OTHER|||||||0.002|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.002
73914898|NCT00618072|147358902|SUPERIORITY_OR_OTHER|||||||0.032|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.032
73914899|NCT00618072|147358903|SUPERIORITY_OR_OTHER|||||||0.142|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.142
73914900|NCT00618072|147358903|SUPERIORITY_OR_OTHER|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.054
73914901|NCT00618072|147358903|SUPERIORITY_OR_OTHER|||||||0.013|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.013
73914902|NCT00618072|147358904|SUPERIORITY_OR_OTHER|||||||0.052|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.052
73914903|NCT00618072|147358904|SUPERIORITY_OR_OTHER|||||||0.143|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.143
73914904|NCT00618072|147358904|SUPERIORITY_OR_OTHER|||||||0.005|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.005
73914905|NCT00618072|147358905|SUPERIORITY_OR_OTHER|||||||0.265|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.265
73914906|NCT00618072|147358905|SUPERIORITY_OR_OTHER|||||||0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.001
73914907|NCT00618072|147358905|SUPERIORITY_OR_OTHER|||||||0.389|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.389
73914908|NCT00618072|147358906|SUPERIORITY_OR_OTHER|||||||0.025|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.025
73914909|NCT00618072|147358906|SUPERIORITY_OR_OTHER|||||||0.162|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.162
73914910|NCT00618072|147358906|SUPERIORITY_OR_OTHER|||||||0.562|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.562
73914911|NCT00618072|147358907|SUPERIORITY_OR_OTHER|||||||0.016|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.016
74027092|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|1.1|||||TWO_SIDED|95.0|0.73|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.62|0.73|
73914912|NCT00618072|147358907|SUPERIORITY_OR_OTHER|||||||0.03|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.03
73914913|NCT00618072|147358907|SUPERIORITY_OR_OTHER|||||||0.15|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.150
73914914|NCT00618072|147358908|SUPERIORITY_OR_OTHER|||||||0.648|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.648
73914915|NCT00618072|147358908|SUPERIORITY_OR_OTHER|||||||0.094|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.094
73914916|NCT00618072|147358908|SUPERIORITY_OR_OTHER|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.054
73914917|NCT00618072|147358909|SUPERIORITY_OR_OTHER|||||||0.092|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.092
73914918|NCT00618072|147358909|SUPERIORITY_OR_OTHER|||||||0.73|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.730
74027093|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.02|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.39|1.02|
74027094|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.38|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.45|1.38|
74085814|NCT03756883|147725768|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of the test product over the placebo.||||<0.0001
73914919|NCT00618072|147358909|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||<0.001
73914920|NCT03292588|147358910|SUPERIORITY|Negative binomial model for the rate of exacerbations in the first year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.73||||0.027|TWO_SIDED|95.0|0.56|0.96|||Regression, Negative Binomial|Adjusted relative rate of exacerbations in the first year.||||0.96|0.56|0.027
73914921|NCT03292588|147358911|SUPERIORITY||Least Square Mean Difference|-0.28||||0.29|TWO_SIDED|95.0|-0.81|0.24|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 12.||Week 12||0.24|-0.81|0.290
73914922|NCT03292588|147358911|SUPERIORITY||Least Square Mean Difference|-0.07||||0.82|TWO_SIDED|95.0|-0.69|0.55|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 24.||Week 24||0.55|-0.69|0.820
73914923|NCT03292588|147358911|SUPERIORITY||Least Square Mean Difference|-0.51||||0.096|TWO_SIDED|95.0|-1.11|0.09|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 36.||Week 36||0.09|-1.11|0.096
73914924|NCT03292588|147358911|SUPERIORITY||Least Square Mean Difference|-0.06||||0.831|TWO_SIDED|95.0|-0.65|0.52|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 48.||Week 48||0.52|-0.65|0.831
73914925|NCT03292588|147358911|SUPERIORITY||Least Square Mean Difference|0.02||||0.947|TWO_SIDED|95.0|-0.6|0.64|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 52.||Week 52||0.64|-0.60|0.947
73914926|NCT03292588|147358912|SUPERIORITY|A generalized logit model was used to analyze Physician Global Assessment Tool at Visit 14. The model included treatment arm as fixed effect as primary exposure but was also adjusted for study site, # of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils ((\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age) \& total serum IgE (\< or ≥540 kUA/L). No imputation of missing data was used for participants who weren't assessed for quality of life measurements at Visit 14.|Odds Ratio (OR)|1.01||||0.974|TWO_SIDED|95.0|0.62|1.64|||Regression, Logistic|||Physician Global Assessment Tool||1.64|0.62|0.974
73914927|NCT03292588|147358913|SUPERIORITY|A generalized logit model was used to analyze the Patient Global Assessment Tool at Visit 14. The model included treatment arm as fixed effect as the primary exposure but was adjusted for study site, # of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils ((\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age) \& total serum IgE (\< or ≥540 kUA/L). No imputation of missing data was used for participants who weren't assessed for quality of life measurements at Visit 14.|Odds Ratio (OR)|0.72||||0.238|TWO_SIDED|95.0|0.42|1.24|||Regression, Logistic|||Patient Global Assessment Tool||1.24|0.42|0.238
73914928|NCT03292588|147358914|SUPERIORITY|A generalized mixed model as described in section 8.3.1 was used to analyze each spirometry and impulse oscillometry parameter, separately, at each visit where the lung function was collected.|Least Square Mean Difference|-0.005||||0.591|TWO_SIDED|95.0|-0.023|0.013|||Mixed Models Analysis|||FEV1/FVC Week 12||0.013|-0.023|0.591
73914929|NCT03292588|147358914|SUPERIORITY||Least Square Mean Difference|-0.011||||0.265|TWO_SIDED|95.0|-0.031|0.008|||Mixed Models Analysis|||FEV1/FVC Week 24||0.008|-0.031|0.265
73914930|NCT03292588|147358914|SUPERIORITY||Least Square Mean Difference|0.011||||0.345|TWO_SIDED|95.0|-0.012|0.033|||Mixed Models Analysis|||FEV1/FVC Week 36||0.033|-0.012|0.345
74085815|NCT03756883|147725768|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of Reference to placebo.||||<0.0001
73914931|NCT03292588|147358914|SUPERIORITY||Least Square Mean Difference|0.013||||0.248|TWO_SIDED|95.0|-0.009|0.036|||Mixed Models Analysis|||FEV1/FVC Week 48||0.036|-0.009|0.248
73914932|NCT03292588|147358914|SUPERIORITY||Least Square Mean Difference|-0.002||||0.864|TWO_SIDED|95.0|-0.023|0.02|||Mixed Models Analysis|||FEV1/FVC Week 52||0.020|-0.023|0.864
73914933|NCT03292588|147358915|SUPERIORITY||Least Square Mean Difference|-0.4||||0.816|TWO_SIDED|95.0|-3.8|3.0|||Mixed Models Analysis|||FEV1PP Week 12||3.0|-3.8|0.816
73914934|NCT03292588|147358915|SUPERIORITY||Least Square Mean Difference|-3.4||||0.095|TWO_SIDED|95.0|-7.4|0.6|||Mixed Models Analysis|||FEV1PP Week 24||0.6|-7.4|0.095
73914935|NCT03292588|147358915|SUPERIORITY||Least Square Mean Difference|1.5||||0.444|TWO_SIDED|95.0|-2.4|5.5|||Mixed Models Analysis|||FEV1PP Week 36||5.5|-2.4|0.444
73914936|NCT03292588|147358915|SUPERIORITY||Least Square Mean Difference|0.6||||0.751|TWO_SIDED|95.0|-3.3|4.6|||Mixed Models Analysis|||FEV1PP Week 48||4.6|-3.3|0.751
73914937|NCT03292588|147358915|SUPERIORITY||Least Square Mean Difference|-2.6||||0.184|TWO_SIDED|95.0|-6.5|1.3|||Mixed Models Analysis|||FEV1PP Week 52||1.3|-6.5|0.184
73914938|NCT03292588|147358916|SUPERIORITY|Negative binomial model for the rate of exacerbations (per year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.85||||0.458|TWO_SIDED|95.0|0.55|1.31|||Mixed Models Analysis|||Did not meet FDA-approved dosing||1.31|0.55|0.458
73914939|NCT03292588|147358917|SUPERIORITY|Negative binomial model for the rate of exacerbations (per year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.67||||0.025|TWO_SIDED|95.0|0.47|0.95|||Regression, Negative Binomial|||Fit FDA-approved dosing||0.95|0.47|0.025
73914940|NCT03292588|147358918|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3587|TWO_SIDED|95.0|0.63|1.18|||Regression, Cox|||||1.18|0.63|0.3587
73914941|NCT00869349|147358934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.04|TWO_SIDED|95.0|-1.1|0.0||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||0.0|-1.1|0.04
73965794|NCT05450458|147467618|OTHER|This study assessed longitudinal effects within a single patient group. Statistical power was calculated using a significance level of 0.05, 80% power, and 60 patients, accounting for IKDC score variability over time. The Friedman test was applied with post hoc analyses (Conover and Bonferroni). Since treatments were not compared, no non-inferiority or equivalence margin was defined|Median Baseline to Month 6|0.18||||0.01|TWO_SIDED|95.0|0.12|0.24||P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.|Friedman Test|The overall p-value is unadjusted. The a priori significance level was set at 0.05 to robustly control the Type I error|This value represents the intra-individual median IKDC improvement from baseline to 6 months after treatment. The analysis was conducted within a single cohort without comparator arms.|The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve IKDC function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.||0.24|0.12|0.01
74085816|NCT03756883|147725769|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of test over placebo.||||<0.0001
74085817|NCT03756883|147725769|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of reference to placebo.||||<0.0001
74085818|NCT03460158|147725771|OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.1524||0.8822|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the relative change in volume and relative change in patient reported outcomes will be the same at 2 weeks post injection||||0.8822
74085819|NCT03460158|147725771|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1466||0.2223|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 4 weeks post injection||||0.2223
74085820|NCT03460158|147725771|OTHER||Mean Difference (Final Values)|-0.369|STANDARD_ERROR_OF_MEAN|0.113||0.0015|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 12 weeks post injection||||0.0015
73914942|NCT00869349|147358935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2||||0.01|TWO_SIDED|95.0|-5.6|-0.8||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||-0.8|-5.6|0.01
73914943|NCT00869349|147358936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.01|TWO_SIDED|95.0|0.5|3.1||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||3.1|0.5|0.01
73914944|NCT03633695|147358937|SUPERIORITY||Mean Difference (Final Values)|-0.177|||<|0.0001|TWO_SIDED|95.0|-0.214|-0.14||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.||-0.140|-0.214|<.0001
74027095|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|2.2|||||TWO_SIDED|95.0|1.53|3.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.12|1.53|
74085821|NCT01546519|147725776|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|90.0|0.95|1.78||||||Cmax Mild HI vs. Normal: Based on pooled variance estimates||1.78|0.95|
73914945|NCT03633695|147358938|SUPERIORITY||Mean Difference (Final Values)|-0.191|||<|0.0001|TWO_SIDED|95.0|-0.223|-0.158||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.||-0.158|-0.223|<.0001
73914946|NCT03633695|147358939|NON_INFERIORITY|Non-inferiority margin was 0.1 logMAR.|Mean Difference (Final Values)|-0.012|||<|0.0001|ONE_SIDED|95.0||0.007||The threshold for statistical significance was p=0.05.|t-test, 1 sided||Acuity Difference = IC-8 IOL Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 IOL Group is inferior to the Control Group by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 IOL group is inferior to the Control Group by less than 0.1 logMAR.||0.007||<.0001
74027096|NCT01025336|147607528|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.18|2.82|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.82|1.18|
74027097|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.25|1.02|
74027098|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.78|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.44|0.78|
74027099|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|1.8|||||TWO_SIDED|95.0|1.06|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.00|1.06|
74027100|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.41|1.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.04|0.41|
74085822|NCT01546519|147725776|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|90.0|0.92|1.83||||||Cmax Moderate HI vs. Normal: Based on pooled variance estimates||1.83|0.92|
74085823|NCT01546519|147725776|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.55|1.37||||||Cmax Severe HI vs. Normal: Based on pooled variance estimates||1.37|0.55|
74085824|NCT01546519|147725776|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|0.9|1.71||||||Css Mild HI vs. Normal: Based on pooled variance estimates||1.71|0.90|
74085825|NCT01546519|147725776|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|90.0|0.89|1.8||||||Css Moderate HI vs. Normal: Based on pooled variance estimates||1.80|0.89|
74085826|NCT01546519|147725776|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.55|1.41||||||Css Severe HI vs. Normal: Based on pooled variance estimates||1.41|0.55|
74085827|NCT01546519|147725777|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|0.89|1.73||||||AUC0-24hr Mild HI vs. Normal: Based on pooled variance estimates||1.73|0.89|
73914947|NCT03633695|147358940|SUPERIORITY||Mean Difference (Final Values)|-0.18|||<|0.0001|TWO_SIDED|95.0|-0.198|-0.163||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 IOL Eye (IC-8 IOL Group) - Fellow Eye (IC-8 IOL Group)|The null hypothesis was that the mean acuity for the IC-8 IOL eyes is greater (i.e., worse) than or equal to that for the fellow eyes. The alternative hypothesis was that the mean for the IC-8 IOL eyes is less (i.e., better) than that for the fellow eyes.||-0.163|-0.198|<.0001
73914948|NCT03633695|147358941|OTHER||Difference in depth of focus|0.91|||||TWO_SIDED||||||||Difference in depth of focus \[IC-8™ IOL Eyes (IC-8™ IOL Group) - Fellow Eyes (IC-8™ IOL Group)\]|||||
73914949|NCT03633695|147358942|NON_INFERIORITY|The non-inferiority margin was 0.1 logMAR.|Mean Difference (Final Values)|0.068|||<|0.0001|ONE_SIDED|95.0||0.082||The threshold for statistical significance was p=0.05.|t-test, 1 sided||Acuity Difference = IC-8 IOL Eyes (IC-8 Group) - Fellow Eyes (IC-8 Group)|The null hypothesis was that the mean acuity for the IC-8 IOL eyes was inferior to the fellow eyes by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 eyes was inferior to the fellow eyes by less than 0.1 logMAR.||0.082||<.0001
73914950|NCT03633695|147358950|NON_INFERIORITY|Non-inferiority margin was 0.12 logMAR.|Mean Difference (Final Values)|0.023|||<|0.0001|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05.|t-test, 1 sided|||The null hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to the Astigmatism Group 1 by 0.12 logMAR or more. The alternative hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to Astigmatism Group 1 by less than 0.12 logMAR.||||<.0001
73914951|NCT02728050|147358961|SUPERIORITY|||||||0.48|||||||Fisher Exact|||"Participants on study receiving CLAGM-S were compared to a historical cohort of newly diagnosed AML/high-risk MDS patients treated with CLAG-M alone, matched for mitoxantrone dose, age, and TRM score.~Number of participants in historical cohort = 71. Number of participants in historical cohort who achieved MRD-negative CR = 55 (77.46%)"||||0.48
73965795|NCT05450458|147467620|SUPERIORITY|This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month IKDC score|Baseline to month 6|0.18||||0.001|TWO_SIDED|95.0|0.14|0.21||P-values from pairwise comparisons were adjusted using the Bonferroni method to control for multiple testing. The global p-value from the Friedman test was not adjusted. An a priori threshold for statistical significance was set at p \< 0.05|Wilcoxon Signed-Rank Test|Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.|Median IKDC improvement from baseline to 6 months in 22 athletes with elevated BMI (≥25). No comparator group was used. Confidence interval calculated via bootstrap (resampling with 1,000 iterations).|The analysis was conducted under the null hypothesis of no change in knee function across time. Data normality was assessed using the Shapiro-Wilk test. Changes across the four time points (baseline, 15 days, 3 months, and 6 months) were evaluated using the Friedman test. Pairwise comparisons were performed post hoc using the Wilcoxon Signed-Rank Test with Bonferroni correction at a 5% significance threshold.||0.21|0.14|0.001
73965796|NCT05450458|147467620|SUPERIORITY|This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month KOOS score|Baseline to Month 6|18.5|||<|0.001|TWO_SIDED|95.0|13.0|22.0||The p-values reported were not adjusted for multiple comparisons, and the a priori threshold for statistical significance was set at p \< 0.05|Wilcoxon Signed-Rank Test|Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.|Median KOOS improvement from baseline to 6 months in 22 athletes with elevated BMI. CI calculated via bootstrap resampling (1,000 iterations). No comparator group was involved.|The analysis was conducted under the null hypothesis of no change in knee function between baseline and six months. The study was designed with sufficient power to detect clinically meaningful improvements, with significance determined at a conventional level||22|13|<0.001
73965797|NCT02794480|147467621|SUPERIORITY||||||<|0.001||||||ELLIPTA versus GSK MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.|||<0.001
73965798|NCT02794480|147467621|SUPERIORITY|||||||0.007||||||ELLIPTA versus AZ MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.|||0.007
73965799|NCT02794480|147467626|SUPERIORITY||Odds Ratio (OR)|5.94|||<|0.001|TWO_SIDED|95.0|2.42||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus GSK MDI||||2.42|<0.001
74027101|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|3.1|||||TWO_SIDED|95.0|1.82|5.24|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||5.24|1.82|
74027102|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|2.4|||||TWO_SIDED|95.0|1.43|4.11|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||4.11|1.43|
74085828|NCT01546519|147725777|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.31|||||TWO_SIDED|90.0|0.91|1.89||||||AUC0-24hr Moderate HI vs. Normal: Based on pooled variance estimates||1.89|0.91|
74085829|NCT01546519|147725777|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.53|1.39||||||AUC0-24hr Severe HI vs. Normal: Based on pooled variance estimates||1.39|0.53|
74085830|NCT02958319|147725785|SUPERIORITY||Median Difference (Final Values)|4.1||||0.82|TWO_SIDED|||||p \< 0.05 was considered statistically significant|GENERAL LINEAL MODEL|GENERAL LINEAL MODEL OF REPEATED MEASURES||||||0.82
74085831|NCT00779402|147725786|OTHER||Hazard Ratio (HR)|0.997||||0.65|TWO_SIDED|95.0|0.693|1.433|||Log Rank|Log Rank Test (two sided) stratified by Gleason Score and Radiation Therapy||||1.433|0.693|0.65
73914952|NCT01751867|147358980|SUPERIORITY_OR_OTHER||ORR %|29.4||||0.003|TWO_SIDED|95.0|15.1|47.5|||Exact binomial proportion test||ORR % = Number of participants who achieved response divided by total ITT participants|Null Hypothesis: threshold for statistical significance = 10%||47.5|15.1|0.003
73914953|NCT01751867|147358980|SUPERIORITY_OR_OTHER||ORR %|25.5|||<|0.001|TWO_SIDED|95.0|17.2|35.3|||Exact binomial proportion test|||Null Hypothesis: threshold for statistical significance = 10%||35.3|17.2|<0.001
73914954|NCT01976338|147359012|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73914955|NCT00777608|147359022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.231|TWO_SIDED|90.0|-0.2|0.08|||ANOVA|||||0.08|-0.2|0.231
73914956|NCT00777608|147359023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.041|TWO_SIDED|90.0|-0.3|-0.008|||ANOVA||Statistical analysis for Week 2|||-0.008|-0.3|0.041
73965800|NCT02794480|147467626|SUPERIORITY||Odds Ratio (OR)|4.16||||0.011|TWO_SIDED|95.0|1.59||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus AZ MDI||||1.59|0.011
73914957|NCT00777608|147359023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.143|TWO_SIDED|90.0|-0.3|0.06|||ANOVA||Statistical analysis for Week 8|||0.06|-0.3|0.143
73914958|NCT00777608|147359023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.226|TWO_SIDED|90.0|-0.2|0.09|||ANOVA||Statistical analysis for Week 12|||0.09|-0.2|0.226
73914959|NCT00777608|147359024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.0||0.324|TWO_SIDED|90.0|-1.2|2.2|||ANOVA||Statistical analysis for Week 4|||2.2|-1.2|0.324
73965801|NCT00262301|147467627|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|||||||0.003
74027103|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.00|0.96|
74027104|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|1.6|||||TWO_SIDED|95.0|0.88|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.04|0.88|
73914960|NCT00777608|147359024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.4||0.285|TWO_SIDED|90.0|-1.5|3.1|||ANOVA|||||3.1|-1.5|0.285
73914961|NCT00777608|147359024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.401|TWO_SIDED|90.0|-2.6|1.9|||ANOVA||Statistical analysis for Week 12|||1.9|-2.6|0.401
73914962|NCT03766581|147359025|SUPERIORITY||Relative Risk (RR)|0.99|||||TWO_SIDED|95.0|0.87|1.1|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 25 mg QD over Placebo||1.10|0.87|
73914963|NCT03766581|147359025|SUPERIORITY||Relative Risk (RR)|0.99|||||TWO_SIDED|95.0|0.83|1.15|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 25 mg BID over Placebo||1.15|0.83|
73914964|NCT03766581|147359025|SUPERIORITY||Relative Risk (RR)|0.93|||||TWO_SIDED|95.0|0.76|1.16|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 50 mg BID over Placebo||1.16|0.76|
74027105|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.64|1.54|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.54|0.64|
73914965|NCT03766581|147359025|SUPERIORITY||Relative Risk (RR)|0.92|||||TWO_SIDED|95.0|0.73|1.18|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 100 mg BID over Placebo||1.18|0.73|
74085832|NCT01386125|147725796|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.14||||0.0007|TWO_SIDED|95.0|-0.22|-0.06|||ANCOVA|||||-0.06|-0.22|0.0007
73914966|NCT03766581|147359025|SUPERIORITY||Relative Risk (RR)|0.91|||||TWO_SIDED|95.0|0.69|1.31|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 200 mg BID over Placebo||1.31|0.69|
73914967|NCT03766581|147359047|SUPERIORITY||Relative Risk (RR)|0.83|||||TWO_SIDED|95.0|0.46|1.49|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 25 mg QD over Placebo||1.49|0.46|
73914968|NCT03766581|147359047|SUPERIORITY||Relative Risk (RR)|0.69|||||TWO_SIDED|95.0|0.36|1.3|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 25 mg BID over Placebo||1.30|0.36|
73914969|NCT03766581|147359047|SUPERIORITY||Relative Risk (RR)|0.72|||||TWO_SIDED|95.0|0.39|1.33|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 50 mg BID over Placebo||1.33|0.39|
73914970|NCT03766581|147359047|SUPERIORITY||Relative Risk (RR)|0.65|||||TWO_SIDED|95.0|0.33|1.25|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 100 mg BID over Placebo||1.25|0.33|
73914971|NCT03766581|147359047|SUPERIORITY||Relative Risk (RR)|1.4|||||TWO_SIDED|95.0|0.87|2.25|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 200 mg BID||2.25|0.87|
73914972|NCT03766581|147359047|SUPERIORITY||Relative Risk (RR)|2.48|||||TWO_SIDED|95.0|0.83|7.42|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 50 mg QD over Placebo||7.42|0.83|
73965802|NCT00262301|147467628|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Log Rank|||||||0.005
73965803|NCT01017146|147467629|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA|||||||<0.001
73965804|NCT01017146|147467629|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA|||||||<0.001
73965805|NCT01017146|147467629|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA|||||||<0.001
73965806|NCT01017146|147467630|SUPERIORITY_OR_OTHER||Percentage of participants|35.6|||<|0.001|TWO_SIDED|95.0|30.7|40.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||40.5|30.7|<0.001
73914973|NCT03766581|147359047|SUPERIORITY||Relative Risk (RR)|1.01|||||TWO_SIDED|95.0|0.15|6.96|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 100 mg QD over Placebo||6.96|0.15|
73914974|NCT01697566|147359108|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Body Weight||||0.006
73914975|NCT01697566|147359108|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Fat Mass||||<0.001
73914976|NCT01697566|147359110|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
73914977|NCT01217801|147359145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|93.77||||0.05|TWO_SIDED|90.0|89.15|98.63|||Regression, Linear|||Linear mixed effect model, log transformed AUC, LSMeans for treatment Film and Tablet, the difference between the LSMeans and 90%CI calculated and transformed to geometric means, ratio estimates and 90%CI||98.63|89.15|0.05
73914978|NCT04967443|147359148|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|102.1|||||TWO_SIDED|90.0|96.14|108.43|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||108.43|96.14|
73914979|NCT04967443|147359148|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.87|||||TWO_SIDED|90.0|98.68|111.44|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||111.44|98.68|
73914980|NCT04967443|147359148|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.45|||||TWO_SIDED|90.0|99.58|109.55|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||109.55|99.58|
73914981|NCT04967443|147359149|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|113.96|||||TWO_SIDED|90.0|102.79|126.34|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||126.34|102.79|
73914982|NCT04967443|147359149|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|126.83|||||TWO_SIDED|90.0|114.32|140.7|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||140.70|114.32|
73914983|NCT04967443|147359149|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|118.07|||||TWO_SIDED|90.0|106.46|130.94|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||130.94|106.46|
74027106|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.71|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.93|0.71|
73914984|NCT04967443|147359150|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|100.91|||||TWO_SIDED|90.0|94.92|107.27|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||107.27|94.92|
73914985|NCT04967443|147359150|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|102.08|||||TWO_SIDED|90.0|95.97|108.57|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||108.57|95.97|
73914986|NCT04967443|147359150|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.04|||||TWO_SIDED|90.0|99.09|109.23|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||109.23|99.09|
73914987|NCT00602797|147359187|OTHER|An interim analysis was conducted after 10 patients were accrued. Since response rate seen at the first interim analysis was superior to that seen with standard of care, a new monitoring rule was approved. Toxicity monitoring would occur after 19 patients. If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated. This will provide 84% power to detect 40% toxicity.|Proportion|6.0|||||TWO_SIDED||||||||If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated.|Adverse events will be graded using the NCI Common Toxicity Criteria (version 3.0).||||
73914988|NCT03473977|147359189|OTHER|||||||0.0001|||||||Fisher Exact|||||||0.0001
73914989|NCT03473977|147359190|OTHER|||||||0.75|||||||Kruskal-Wallis|||||||0.75
73914990|NCT03473977|147359191|OTHER|||||||0.006|||||||Kruskal-Wallis|||||||0.006
73914991|NCT03473977|147359192|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
73914992|NCT03473977|147359193|OTHER|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
73914993|NCT03473977|147359194|OTHER|||||||0.014|||||||Kruskal-Wallis|||||||0.014
73914994|NCT03473977|147359195|OTHER|||||||0.78|||||||Kruskal-Wallis|||Pain Score Comparison||||0.78
73914995|NCT03473977|147359195|OTHER|||||||0.34|||||||Kruskal-Wallis|||Non-pain score comparison||||0.34
73914996|NCT03473977|147359195|OTHER|||||||0.66|||||||Kruskal-Wallis|||Satisfaction score comparison||||0.66
73931010|NCT01462357|147391796|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.16|1.15||||||Immune response to anti-HPV-16 in terms of seroconversion rates (SCR): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||1.15|-1.16|
73914997|NCT04502693|147359197|OTHER|Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for Vaccine Effectiveness (VE) against the selected strain panel between the MenB\_0\_2\_6 and the ACWY groups is above 65%. VE is defined as 1- Risk Ratio (RR) = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE (Vaccine Effectiveness)|83.2|||||TWO_SIDED|97.5|81.9|84.4||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 3-dose (0,2,6-months) schedule in MenB\_0\_2\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||84.4|81.9|
73914998|NCT04502693|147359197|OTHER|"Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\_0\_ 6 and the ACWY groups is above 65%.~VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage."|VE|81.8|||||TWO_SIDED|97.5|80.4|83.1||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,6-M) schedule in MenB\_0\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||83.1|80.4|
73914999|NCT04502693|147359198|OTHER|Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\_0\_2\_6 and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE|78.7|||||TWO_SIDED|97.5|77.2|80.1||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,2-M) schedule in MenB\_0\_2\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||80.1|77.2|
73915000|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||1.10|0.84|
73915001|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.86|||||TWO_SIDED|95.0|0.75|0.98||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||0.98|0.75|
73915002|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.78|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||1.02|0.78|
73965807|NCT01017146|147467630|SUPERIORITY_OR_OTHER||Percentage of participants|23.9|||||TWO_SIDED|95.0|19.6|28.3|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||28.3|19.6|
74085833|NCT01386125|147725797|SUPERIORITY_OR_OTHER_LEGACY||Difference is LS Means|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.45|-0.15|||Constrained longitudinal data analysis|||||-0.15|-0.45|<0.0001
73965808|NCT01017146|147467631|SUPERIORITY_OR_OTHER||Percentage of participants|28.8|||<|0.001|TWO_SIDED|95.0|24.2|33.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.|||33.5|24.2|<0.001
73965809|NCT01017146|147467631|SUPERIORITY_OR_OTHER||Percentage of participants|16.1|||||TWO_SIDED|95.0|12.4|19.9|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.|||19.9|12.4|
73965810|NCT01172418|147467661|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
73965811|NCT01172418|147467662|SUPERIORITY|||||||0.37|||||||Log Rank|||||||0.37
73965812|NCT01172418|147467663|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
73965813|NCT01172418|147467664|SUPERIORITY|||||||0.25|||||||Log Rank|||||||0.25
73965814|NCT02272816|147467665|OTHER||Percentage|95.6|||||ONE_SIDED|95.0||98.6||||||||98.6||
73965815|NCT02272816|147467666|OTHER||Percentage|45.0|||||TWO_SIDED|95.0|30.2|59.9||||||||59.9|30.2|
73965816|NCT02272816|147467667|OTHER||Percentage|100.0|||||TWO_SIDED|95.0|92.6|100.0||||||||100|92.6|
73965817|NCT00715884|147467684|NON_INFERIORITY_OR_EQUIVALENCE|The null inferiority hypothesis was that the upper limit of the 95% confidence interval is equal or greater than the non-inferiority margin 5%. The alternative non-inferiority hypothesis for this study assumed that the upper limit of the 95% confidence interval would be less than the non-inferiority margin 5%.|Difference between TLF rates|2.58|||||ONE_SIDED|95.0||5.55||In the CYPHER® ELITE™ arm the TLF rate was 5.36% (23/429) compared with 2.78% (6/216) in the CYPHER® Bx VELOCITY® arm, a difference in rates of 2.58%, upper limit of 95% two sided confidence interval of 5.55%.||||Sample sizes of 1,061 from the ELITE™ group and 531 from the CYPHER® group were planned to achieve 90 percent power at a 2.5 percent significance level using an one-sided equivalence test, assuming a 10 percent TLF rate in each group and the maximum allowable rate difference between the groups being 5 percent. The total sample size was increased to 1,770 patients to account for an approximately 90 percent compliance to clinical follow-up.||5.55||
73965818|NCT00715884|147467685|SUPERIORITY_OR_OTHER||Difference between event rates|-0.4||||0.549|TWO_SIDED|95.0|-1.3|1.0|||Fisher Exact|||||1.0|-1.3|0.549
73965819|NCT00715884|147467686|SUPERIORITY_OR_OTHER||Difference between event rates|13.8|||<|0.001|TWO_SIDED|95.0|9.2|18.9|||Fisher Exact|||||18.9|9.2|<.001
73965820|NCT00715884|147467687|SUPERIORITY_OR_OTHER||Difference between event rates|0.7||||0.724|TWO_SIDED|95.0|-2.2|4.2|||Fisher Exact|||||4.2|-2.2|0.724
73915003|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.92|||||TWO_SIDED|95.0|0.76|1.11||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.11|0.76|
73915004|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|1.17|||||TWO_SIDED|95.0|0.97|1.41||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.41|0.97|
73915005|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|1.27|||||TWO_SIDED|95.0|1.05|1.54||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.54|1.05|
73915006|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.02|0.77|
73915007|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.88|||||TWO_SIDED|95.0|0.77|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.02|0.77|
73915008|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.99|||||TWO_SIDED|95.0|0.86|1.14||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.14|0.86|
74085834|NCT02010996|147725826|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Chi-squared|||||||0.05
73915009|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.86|||||TWO_SIDED|95.0|0.73|1.01||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||1.01|0.73|
73915010|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.83|||||TWO_SIDED|95.0|0.71|0.98||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||0.98|0.71|
73915011|NCT04502693|147359201|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.97|||||TWO_SIDED|95.0|0.82|1.14||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||1.14|0.82|
73965821|NCT00715884|147467688|SUPERIORITY_OR_OTHER||Difference between event rates|-1.3||||0.407|TWO_SIDED|95.0|-3.5|1.4|||Fisher Exact|||||1.4|-3.5|0.407
73965822|NCT00715884|147467689|SUPERIORITY_OR_OTHER||Difference between event rates|2.11||||0.203|TWO_SIDED|95.0|-0.84|4.48|||Fisher Exact|||||4.48|-0.84|0.203
73965823|NCT00715884|147467690|SUPERIORITY_OR_OTHER||Difference between event rates|2.35||||0.22|TWO_SIDED|95.0|-1.24|5.28|||Fisher Exact|||||5.28|-1.24|0.22
73915012|NCT04502693|147359202|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|11.29|||||TWO_SIDED|95.0|5.88|19.01|||Difference in percentage of participants|||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup A at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||19.01|5.88|
73965824|NCT00715884|147467691|SUPERIORITY_OR_OTHER||Difference between event rates|2.83||||0.166|TWO_SIDED|95.0|-1.28|6.26|||Fisher Exact|||||6.26|-1.28|0.166
73965825|NCT00715884|147467692|SUPERIORITY_OR_OTHER||Difference between event rates|2.59||||0.2|TWO_SIDED|95.0|-1.35|5.85|||Fisher Exact|||||5.85|-1.35|0.200
73965826|NCT00715884|147467693|SUPERIORITY_OR_OTHER||Difference between event rates|11.56||||0.14|TWO_SIDED|95.0|-3.73|24.64|||Fisher Exact|||||24.64|-3.73|0.140
73965827|NCT00715884|147467694|SUPERIORITY_OR_OTHER||Difference between event rates|5.17||||0.17|TWO_SIDED|95.0|-2.03|10.83|||Fisher Exact|||||10.83|-2.03|0.170
73965828|NCT00715884|147467695|SUPERIORITY_OR_OTHER||Difference between event rates|0.24||||1|TWO_SIDED|95.0|-5.61|5.43|||Fisher Exact|||||5.43|-5.61|1.0
73965829|NCT00715884|147467696|SUPERIORITY_OR_OTHER||Difference between event rates|0.24||||1|TWO_SIDED|95.0|-1.92|1.63|||Fisher Exact|||||1.63|-1.92|1.0
73965830|NCT00715884|147467697|SUPERIORITY_OR_OTHER||Difference between event rates|0.49||||0.801|TWO_SIDED|95.0|-2.73|2.91|||Fisher Exact|||||2.91|-2.73|0.801
74027107|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|1.01|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.04|1.01|
73915013|NCT04502693|147359202|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|47.22|||||TWO_SIDED|95.0|38.14|56.3||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup C at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||56.30|38.14|
73915014|NCT04502693|147359202|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|35.31|||||TWO_SIDED|95.0|26.88|44.49||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup W at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||44.49|26.88|
73915015|NCT04502693|147359202|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|26.99|||||TWO_SIDED|95.0|19.38|35.81||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup Y at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||35.81|19.38|
73915016|NCT04502693|147359203|OTHER|Effectiveness of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for VE against the selected strain panel between the ABCWY and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in ABCWY\_Pooled group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE|77.9|||||TWO_SIDED|95.0|76.6|79.2||||||To demonstrate the effectiveness of the MenABCWY vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by enc-hSBA at 1 month after the last MenABCWY vaccination (Day 211) when compared to 1 month after the MenACWY vaccination.||79.2|76.6|
74027108|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.84|2.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.06|0.84|
73915017|NCT04502693|147359204|NON_INFERIORITY|Non-inferiority of MenABCWY to rMenB+OMV NZ is demonstrated if LL of the 2-sided 95% CI for the difference in percentages of samples with bactericidal serum activity at 1:4 dilution is above -5%.|Difference in percentage of participants|-0.61|||||TWO_SIDED|95.0|-1.25|0.03||||||To demonstrate the non-inferiority of the effectiveness of the MenABCWY vaccine (0,6-months schedule) compared to the rMenB+OMV NZ vaccine (0,2-months) in terms of percentage of samples with bactericidal serum activity using enc-hSBA against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains.||0.03|-1.25|
73915018|NCT03334539|147359259|SUPERIORITY||Least Squares (LS) Mean Difference|0.11||||0.3378|TWO_SIDED|95.0|-0.12|0.34||P-value was calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.34|-0.12|0.3378
73915019|NCT03334539|147359259|SUPERIORITY||LS Mean Difference|0.12||||0.2883|TWO_SIDED|95.0|-0.1|0.35||P-value was calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.35|-0.10|0.2883
73915020|NCT03334539|147359259|OTHER||LS Mean Difference|0.01||||0.9293|TWO_SIDED|95.0|-0.22|0.24||P-value calculated using a model with treatment, baseline score, and site as covariates|ANCOVA|||||0.24|-0.22|0.9293
73915021|NCT03334539|147359260|SUPERIORITY||LS Mean Difference|-0.3||||0.1473|TWO_SIDED|95.0|-0.7|0.1||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.1|-0.7|0.1473
73915022|NCT03334539|147359260|SUPERIORITY||LS Mean Difference|-0.3||||0.2321|TWO_SIDED|95.0|-0.7|0.2||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.2|-0.7|0.2321
74027109|NCT01025336|147607529|SUPERIORITY_OR_OTHER||Ratio of GMT|3.1|||||TWO_SIDED|95.0|1.89|5.2|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||5.20|1.89|
73915023|NCT03334539|147359260|OTHER||LS Mean Difference|0.0||||0.8217|TWO_SIDED|95.0|-0.4|0.5||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.5|-0.4|0.8217
73915024|NCT04974697|147359330|SUPERIORITY|The superiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 40 points for myope.|Least-square Mean|58.1|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|50.9|65.4|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 22 subjects were required to test superiority for myope.||65.4|50.9|
73915025|NCT04974697|147359330|SUPERIORITY|The superiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 32 points for hyperope.|Least-square Mean|55.0|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|47.2|62.8|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 18 subjects were required to test superiority for hyperope.||62.8|47.2|
73859707|NCT03054350|147265583|SUPERIORITY||Least squares mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.121||0.0033|TWO_SIDED|95.0|0.13|0.62|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.62|0.13|0.0033
73859708|NCT03054350|147265583|SUPERIORITY||Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.12||0.0002|TWO_SIDED|95.0|0.26|0.74|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.74|0.26|0.0002
73859709|NCT03054350|147265583|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.3289|TWO_SIDED|94.0|-0.01|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.01|0.3289
73859710|NCT03054350|147265583|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.007||0.2607|TWO_SIDED|95.0|-0.01|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.01|0.2607
73859711|NCT03054350|147265583|SUPERIORITY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.007||0.0252|TWO_SIDED|95.0|0.0|0.03|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.03|0.00|0.0252
73915026|NCT04974697|147359331|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold 0.00 logMAR for Distance.|Least-square Mean|-0.129|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.167|-0.091|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 42 subjects were required to test superiority for distance (4m).||-0.091|-0.167|
73915027|NCT04974697|147359331|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Intermediate.|Least-square Mean|-0.046|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.084|-0.008|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 7 subjects were required to test superiority for intermediate (64 cm).||-0.008|-0.084|
74027110|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.72|1.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.51|0.72|
73859712|NCT03054350|147265585|SUPERIORITY||Least squares mean difference|3.31|STANDARD_ERROR_OF_MEAN|1.303||0.0154|TWO_SIDED|95.0|0.67|5.94|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||5.94|0.67|0.0154
73859713|NCT03054350|147265585|SUPERIORITY||Least squares mean difference|4.61|STANDARD_ERROR_OF_MEAN|1.261||0.0008|TWO_SIDED|95.0|2.06|7.16|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||7.16|2.06|0.0008
73915028|NCT04974697|147359331|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Near.|Least-square Mean|0.067|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|0.029|0.105|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 36 subjects were required to test superiority for near (40 cm).||0.105|0.029|
73965831|NCT00715884|147467698|SUPERIORITY_OR_OTHER||Difference between event rates|-0.92||||0.341|TWO_SIDED|95.0|-3.56|0.6|||Fisher Exact|||||0.60|-3.56|0.341
73859714|NCT03054350|147265585|SUPERIORITY||Least squares mean difference|5.93|STANDARD_ERROR_OF_MEAN|1.296|<|0.0001|TWO_SIDED|95.0|3.31|8.56|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||8.56|3.31|<0.0001
73859715|NCT03054350|147265585|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.273||0.3572|TWO_SIDED|95.0|-0.3|0.81|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.81|-0.30|0.3572
73859716|NCT03054350|147265585|SUPERIORITY||Least squares mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.252||0.4758|TWO_SIDED|95.0|-0.33|0.69|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.69|-0.33|0.4758
73859717|NCT03054350|147265585|SUPERIORITY||Least squares mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.254||0.2048|TWO_SIDED|95.0|-0.19|0.84|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.84|-0.19|0.2048
73965832|NCT00715884|147467699|SUPERIORITY_OR_OTHER||Difference between event rates|0.0||||1|TWO_SIDED|95.0|-2.14|1.28|||Fisher Exact|||||1.28|-2.14|1.00
73965833|NCT00715884|147467700|SUPERIORITY_OR_OTHER||Difference between event rates|0.47||||0.668|TWO_SIDED|95.0|-1.72|1.96|||Fisher Exact|||||1.96|-1.72|0.668
73965834|NCT02412748|147467758|SUPERIORITY|||||||0.962|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.962
73859718|NCT03054350|147265587|SUPERIORITY|||||||0.9373|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.9373
73859719|NCT03054350|147265587|SUPERIORITY|||||||0.6623|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.6623
73859720|NCT03054350|147265587|SUPERIORITY|||||||0.9374|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.9374
73859721|NCT03054350|147265587|SUPERIORITY|||||||0.2085|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.2085
73859722|NCT03054350|147265587|SUPERIORITY|||||||0.0016|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0016
73915029|NCT04974697|147359332|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|8.4|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|3.1|13.7|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||13.7|3.1|
73915030|NCT04974697|147359332|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|5.0|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-1.2|11.2|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||11.2|-1.2|
73915031|NCT04974697|147359333|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|6.9|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|0.0|13.7|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||13.7|0.0|
73915032|NCT04974697|147359333|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|3.3|STANDARD_ERROR_OF_MEAN|4.03|||TWO_SIDED|95.0|-4.7|11.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||11.3|-4.7|
73915033|NCT04974697|147359334|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|11.2|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|5.0|17.4|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||17.4|5.0|
73915034|NCT04974697|147359334|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|10.0|STANDARD_ERROR_OF_MEAN|3.64|||TWO_SIDED|95.0|2.8|17.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||17.3|2.8|
73965835|NCT02412748|147467759|SUPERIORITY|||||||0.982|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.982
73915035|NCT02010775|147359335|OTHER||Least Squares Mean (LS) Mean Difference|-3.88|||<|0.001|TWO_SIDED|95.0|-5.58|-2.19|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-2.19|-5.58|< 0.001
73915036|NCT02010775|147359335|OTHER||LS Mean Difference|-6.32|||<|0.001|TWO_SIDED|95.0|-8.02|-4.62|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-4.62|-8.02|<0.001
73915037|NCT02010775|147359335|OTHER||LS Mean Difference|-6.89|||<|0.001|TWO_SIDED|95.0|-8.56|-5.22|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-5.22|-8.56|<0.001
73915038|NCT02010775|147359335|OTHER||LS Mean Difference|-7.68|||<|0.001|TWO_SIDED|95.0|-9.35|-6.0|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-6.00|-9.35|<0.001
73915039|NCT02010775|147359336|OTHER||Percentage Difference|31.5||||0.008|TWO_SIDED|95.0|9.8|53.3|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using Cochran-Mantel-Haenszel (CMH) tests stratified by baseline MMPS.||||53.3|9.8|0.008
73915040|NCT02010775|147359336|OTHER||Percentage Difference|48.2|||<|0.001|TWO_SIDED|95.0|28.6|67.8|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||67.8|28.6|< 0.001
73915041|NCT02010775|147359336|OTHER||Percentage Difference|54.3|||<|0.001|TWO_SIDED|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||72.6|36.1|< 0.001
73915042|NCT02010775|147359336|OTHER||Percentage Difference|54.3|||<|0.001|TWO_SIDED|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||72.6|36.1|<0.001
73915043|NCT01197560|147359340|SUPERIORITY|||||||0.079|||||||Fisher Exact|||Pertains to all participants; row 1||||0.079
73915044|NCT01197560|147359340|SUPERIORITY|||||||0.279|||||||Fisher Exact|||Pertains to GCB Subtype; row 2||||0.279
73915045|NCT01197560|147359340|SUPERIORITY|||||||0.179|||||||Fisher Exact|||Pertains to non-GCB Sub-type; row 3||||0.179
73915046|NCT01197560|147359341|SUPERIORITY|||||||0.091|||||||Fisher Exact|||Pertains to all participants||||0.091
73915047|NCT01197560|147359342|SUPERIORITY|||||||0.109|||||||Fisher Exact|||||||0.109
73915048|NCT01197560|147359343|SUPERIORITY|||||||0.16|||||||Fisher Exact|||Pertains to all participants; row 1||||0.160
73915049|NCT01197560|147359344|SUPERIORITY|||||||0.529|||||||Log Rank|||||||0.529
73915050|NCT01197560|147359345|SUPERIORITY|||||||0.972|||||||Log Rank|||||||0.972
73915051|NCT01197560|147359346|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.020
73915052|NCT01197560|147359347|SUPERIORITY|||||||0.211|||||||Log Rank|||||||0.211
73915053|NCT02166905|147359382|OTHER||Hazard Ratio (HR)|0.4||||0.177|TWO_SIDED|90.0|0.1|1.2|||Log Rank||Reference=arm 1|||1.2|0.1|0.177
73915054|NCT02617628|147359388|EQUIVALENCE|The odds ratio for relapse versus non-relapse for the AR group relative to the BR group was analyzed, as well as the corresponding odds ratio for unknown relative to non-relapse.|Odds Ratio (OR)|1.56||||0.38|TWO_SIDED|95.0|0.57|4.27|||Regression, Logistic||Threshold for significance was set at p\<.05|Based on Lee et al. we estimated a 23-33% group difference in relapse by month 3. Power estimates calculated this estimate with a 2-sided alpha of .05 and a baseline sample size of 100 per group resulted in 80% power to detect a difference of approximately 20% (OR = 2.4) between groups assuming a rate of 50% in the control condition and 10% and 20% attrition by 3- and 6-month follow-ups. For the 86 participants randomized and released, with 80% power; and odds ratio of 3.5.||4.27|0.57|0.38
73915055|NCT02617628|147359389|SUPERIORITY||Cox Proportional Hazard|-0.74486||||0.01|TWO_SIDED|95.0|||||Regression, Cox|||We used Cox proportional hazards regression model to compare the groups on time to reincarceration.||||0.01
73965836|NCT02412748|147467760|SUPERIORITY|||||||0.534|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.534
73965837|NCT02412748|147467761|SUPERIORITY|||||||0.73|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.730
73965838|NCT02412748|147467762|SUPERIORITY|||||||0.927|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.927
73965839|NCT02412748|147467763|SUPERIORITY|||||||0.841|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.841
73965840|NCT02412748|147467764|SUPERIORITY|||||||0.722|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.722
74027111|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.52|0.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.94|0.52|
74027112|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.58|1.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.47|0.58|
73859723|NCT03054350|147265587|SUPERIORITY|||||||0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0001
73965841|NCT02412748|147467765|SUPERIORITY|||||||0.715|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.715
73965842|NCT02412748|147467766|SUPERIORITY|||||||0.9|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.900
73965843|NCT02412748|147467767|SUPERIORITY|||||||0.271|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.271
73965844|NCT02412748|147467768|SUPERIORITY|||||||0.987|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.987
73965845|NCT02412748|147467769|SUPERIORITY|||||||0.967|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.967
74027113|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.25|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.59|0.25|
74027114|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.85|2.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.32|0.85|
73859724|NCT03054350|147265589|SUPERIORITY|||||||0.2708|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.2708
73859725|NCT03054350|147265589|SUPERIORITY|||||||0.0966|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.0966
73859726|NCT03054350|147265589|SUPERIORITY|||||||0.0424|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.0424
73859727|NCT03054350|147265591|SUPERIORITY|||||||0.0207|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0207
73965846|NCT02412748|147467770|SUPERIORITY|||||||0.693|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.693
73859728|NCT03054350|147265591|SUPERIORITY|||||||0.0022|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0022
73859729|NCT03054350|147265591|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||<0.0001
73859730|NCT03054350|147265591|SUPERIORITY|||||||0.0062|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0062
73859731|NCT03054350|147265591|SUPERIORITY|||||||0.0002|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0002
73859732|NCT03054350|147265591|SUPERIORITY||||||<|0.0001||||||test of treatment group difference based on ANCOVA model|ANCOVA|||Hepcidin||||<0.0001
73859733|NCT03242772|147265609|OTHER|||||||0.2664||||||Significance at \<0.05|95% confidence interval|confidence interval (CI) = -3.5729 - 11.6929|||Presentation of results will include p-values and 95% confidence intervals for the least mean square values at weeks 0, 10, 24 (week 24 is exploratory).|||0.2664
73859734|NCT03242772|147265610|OTHER|||||||0.3721||||||Significance at \<0.05|95% confidence interval|confidence interval (CI) = -17.7698 - 7.2698|||Presentation of results will include p-values and 95% confidence intervals for the least mean square values at weeks 0, 10, 24 (week 24 is exploratory).|||0.3721
73859735|NCT00089986|147265612|SUPERIORITY_OR_OTHER||Rate difference|1.1||||0.329|ONE_SIDED|90.0|-2.1||||Chi-squared||||||-2.1|0.329
73859736|NCT00089986|147265612|SUPERIORITY_OR_OTHER||Rate Difference|-4.4||||0.879|ONE_SIDED|90.0|-9.4||||Chi-squared||||||-9.4|0.879
73915056|NCT02065375|147359390|SUPERIORITY||Difference in proportion of patients|-1.2||||0.4543|TWO_SIDED|95.0|-21.3|18.9|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 1.0% and placebo were one sided.||||18.9|-21.3|0.4543
73915057|NCT02065375|147359390|SUPERIORITY||Difference in proportion of patients|8.2||||0.2297|TWO_SIDED|95.0|-13.5|29.8|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 0.5% and placebo were one sided.||||29.8|-13.5|0.2297
73915058|NCT02065375|147359391|SUPERIORITY||Difference in proportion of patients|-21.6||||0.028|TWO_SIDED|95.0|-43.1|0.0|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 1.0% and placebo were one sided.||||0.00|-43.1|.0280
73915059|NCT02065375|147359391|SUPERIORITY||Difference in proportion of patients|-24.0||||0.0192|TWO_SIDED|95.0|-45.8|-2.2|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 0.5% and placebo were one sided.||||-2.2|-45.8|0.0192
73915060|NCT02801331|147359392|EQUIVALENCE|A test of equivalence was conducted for unadjusted comparisons. A chi squared test of proportions was used for unadjusted comparisons.||||||0.6||||||Unadjusted|Chi-squared|||||||.60
73915061|NCT02801331|147359393|EQUIVALENCE|A statistical test comparing cumulative morphine dose was performed for the cohort that was treated with morphine (n=60)||||||0.62|||||||t-test, 2 sided|degrees of freedom =58 for cohort analyzed that received morphine treatment.||||||.62
73915062|NCT02801331|147359394|EQUIVALENCE|A statistical test comparing day of life discharged among untreated infants who completed hospitalization at study site (n=181).||||||0.29|||||||t-test, 2 sided|df = 179 based on number of infants who completed hospitalization at study site.||||||0.29
73915063|NCT02801331|147359395|EQUIVALENCE|A statistical test comparing day of life discharged among untreated infants (n=121)||||||0.55|||||||t-test, 2 sided|df = 119 based on number of infants who did not receive morphine treatment.||||||0.55
73859737|NCT03995680|147265626|SUPERIORITY||Difference in Egg Reduction Rate (%)|2.3|||||TWO_SIDED|95.0|-7.8|12.6|||Regression, Logistic|Adjusted for age, sex, weight and baseline hookworm infection intensity (light or moderate/heavy)||The 95% confidence intervals (CIs) for ERRs and the difference between ERRs were estimated via bootstrap resampling. Superiority was claimed if the 95% confidence interval of the difference in ERRs did not include unity. Logistic regression models were used to assess efficacy in terms of CRs. In a subsequent analysis an adjusted logistic regression (adjustment for age, sex, weight and baseline infection intensity) was performed.||12.6|-7.8|
73859738|NCT01062841|147265630|SUPERIORITY_OR_OTHER||Rate Ratio|0.77|||<|0.05|TWO_SIDED|95.0|0.62|0.94||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.94|0.62|<0.05
73859739|NCT01062841|147265631|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.54||||0.04|TWO_SIDED|95.0|0.3|0.97|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||0.97|0.30|0.04
73859740|NCT01062841|147265632|SUPERIORITY_OR_OTHER||Rate Ratio|0.78|||<|0.05|TWO_SIDED|95.0|0.64|0.96||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.96|0.64|<0.05
73915064|NCT02801331|147359396|EQUIVALENCE|A statistical test comparing day of life discharged among treated infants, n=60||||||0.36|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.36
73915065|NCT02801331|147359397|EQUIVALENCE|A test of equivalence was conducted for unadjusted comparisons. A t test of means was used for unadjusted comparisons.||||||0.56|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.56
73915066|NCT02801331|147359398|EQUIVALENCE|A statistical test comparing day of life infant started treatment as performed for the cohort that was treated with morphine (n=60)||||||0.25|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.25
73915067|NCT05438888|147359404|OTHER||Hazard Ratio (HR)|0.753|||<|0.001|TWO_SIDED|95.0|0.711|0.798|||Log Rank|||||0.798|0.711|<0.001
73915068|NCT05438888|147359405|OTHER||Hazard Ratio (HR)|0.687|||<|0.001|TWO_SIDED|95.0|0.622|0.76|||Log Rank|||||0.760|0.622|<0.001
73915069|NCT05438888|147359406|OTHER||Hazard Ratio (HR)|0.638|||<|0.001|TWO_SIDED|95.0|0.57|0.714|||Log Rank|||||0.714|0.570|<0.001
73915070|NCT05438888|147359407|OTHER||Hazard Ratio (HR)|0.854|||<|0.001|TWO_SIDED|95.0|0.791|0.922|||Log Rank|||||0.922|0.791|<0.001
73915071|NCT05438888|147359408|OTHER||Hazard Ratio (HR)|0.638|||<|0.001|TWO_SIDED|95.0|0.57|0.715|||Log Rank|||||0.715|0.570|<0.001
73915072|NCT05438888|147359409|OTHER||Hazard Ratio (HR)|0.868|||<|0.001|TWO_SIDED|95.0|0.807|0.934|||Log Rank|||||0.934|0.807|<0.001
73915073|NCT05438888|147359410|OTHER||Hazard Ratio (HR)|0.646|||<|0.001|TWO_SIDED|95.0|0.503|0.83|||Log Rank|||||0.830|0.503|<0.001
73965847|NCT02412748|147467771|SUPERIORITY|||||||0.557|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.557
73965848|NCT02412748|147467772|SUPERIORITY|||||||0.681|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.681
74085835|NCT02508116|147725869|SUPERIORITY||Odds Ratio (OR)|1.6||||0.03|TWO_SIDED|95.0|1.07|2.42|||Regression, Logistic|||The sample size calculation was based on two factors: 1) the rate of pre-study prasugrel/ticagrelor use (\~20%) and 2) anticipated increase in prasugrel/ticagrelor prescribing based on the frequency CYP2C19 LOF variants (\~30-35%). We estimated a 15% difference in the use of prasugrel/ticagrelor in the two groups (35% in the genotyped group and 20% in the control group). A sample size of 138 per group (a total of 276) would provide 80% power at an alpha level of 0.05 to detect this difference.||2.42|1.07|0.03
74085836|NCT02508116|147725871|SUPERIORITY|||||||0.27|||||||Log Rank|||The incidence of first MACE between the groups were compared by use of Kaplan-Meier estimators; statistical tests were based on log-rank tests.||||0.27
73915074|NCT04666051|147359430|SUPERIORITY|Data from both groups has been collected compared to verify significant statistical difference||||||0.022|||||||Chi-squared|||||||0.022
73915075|NCT01651195|147359431|SUPERIORITY|We estimated that, with a power of 85% and at a significance level of 0.05 (Power 0.85, ß=0.14990 and α=0.05), we needed 467 conscripts per group to show a 17% difference between the groups. Each conscript was randomly allocated to the probiotic or the control group according to a computer generated, 8-blocked randomization list.|||||<|0.05|||||||Fisher Exact||||"Result variables were analyzed according to intention to treat (ITT) principle. Missing data was handled by statistic modeling. Data on symptom diaries were calculated as follows: the incidence and duration of individual infection symptoms and respiratory episodes were analyzed between the intervention groups using time to event analysis (cox model for hazard) and duration analysis (gamma regression model). The results are expressed as a hazard ratio (incidence rate ratio) of symptoms and the mean duration of symptoms (days) with 95% confidence intervals or standard deviations. The sums of respiratory and gastrointestinal symptoms were calculated with gamma regression analysis."|||< 0.05
73915076|NCT01651195|147359432|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
73915077|NCT01651195|147359433|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
73915078|NCT01651195|147359434|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
73915079|NCT05426902|147359549|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||<0.0001
73915080|NCT05426902|147359550|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Baseline (month 1) vs. intervention period (month 2)||||0.6
73915081|NCT05426902|147359551|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Baseline (month 1) vs. intervention period (month 2)||||0.2
73915082|NCT05426902|147359552|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||<0.0001
73915083|NCT05426902|147359553|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||0.4
73915084|NCT05426902|147359558|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"I feel good about my medical visit at baseline (month 1) vs. intervention period (month 2)."||||0.7
73915085|NCT05426902|147359558|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||"My rheumatologist gave me his/her full attention at baseline (month 1) vs. intervention period (month 2)."||||0.8
73915086|NCT05426902|147359558|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"I was able to say everything I wanted to say to my rheumatologist at baseline (month 1) vs. intervention period (month 2)."||||1.0
73915087|NCT05426902|147359560|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"My rheumatologist and I agreed on how active my lupus was today at baseline (month 1) vs. intervention period (month 2)."||||0.7
73915088|NCT05426902|147359560|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||"I understand the care recommendations that my doctor or provider gave me today at baseline (month 1) vs. intervention period (month 2)."||||0.8
73915089|NCT05426902|147359561|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline vs. Follow-Up||||0.02
73915090|NCT05426902|147359562|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke meets my approval at baseline (month 1) vs. intervention period (month 2)."||||0.7
73915091|NCT05426902|147359562|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke is appealing to me at baseline (month 1) vs. intervention period (month 2)."||||1.0
73965849|NCT02412748|147467773|SUPERIORITY|||||||0.389|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.389
73965850|NCT02412748|147467774|SUPERIORITY|||||||0.846|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.846
73965851|NCT02412748|147467775|SUPERIORITY|||||||0.871|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.871
73965852|NCT02412748|147467776|SUPERIORITY|||||||0.986|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.986
73915092|NCT05426902|147359562|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||"I like SLE@Duke at baseline (month 1) vs. intervention period (month 2)."||||0.5
73915093|NCT05426902|147359562|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||"I welcome SLE@Duke at baseline (month 1) vs. intervention period (month 2)."||||0.6
73915094|NCT05426902|147359563|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke seems fitting at baseline (month 1) vs. intervention period (month 2)."||||0.7
73915095|NCT05426902|147359563|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke seems suitable at baseline (month 1) vs. intervention period (month 2)."||||0.7
73915096|NCT05426902|147359563|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke seems applicable at baseline (month 1) vs. intervention period (month 2)."||||1.0
74027115|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.82|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.13|0.82|
74085837|NCT02630316|147725873|SUPERIORITY||Hodges-Lehmann|21.0||||0.0043|TWO_SIDED|95.0|7.0|37.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category.|ANCOVA|||||37.0|7.0|0.0043
73915097|NCT05426902|147359563|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke seems like a good match at baseline (month 1) vs. intervention period (month 2)."||||1.0
74027116|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|0.6|||||TWO_SIDED|95.0|0.37|0.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.97|0.37|
73915098|NCT05426902|147359564|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems implementable at baseline (month 1) vs. intervention period (month 2)."||||0.3
73915099|NCT05426902|147359564|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems possible at baseline (month 1) vs. intervention period (month 2)."||||0.3
73915100|NCT05426902|147359564|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||"SLE@Duke seems doable at baseline (month 1) vs. intervention period (month 2)."||||0.4
73915101|NCT05426902|147359564|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems easy to use at baseline (month 1) vs. intervention period (month 2)."||||0.3
73915102|NCT02128113|147359635|SUPERIORITY||LS Mean difference (Net)|26.95||||0.4529|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension (pooled) - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension pooled (0.5% and 1.0%) versus Vehicle Ophthalmic Solution||||0.4529
73915103|NCT02128113|147359635|SUPERIORITY||LS Mean difference (Net)|64.31||||0.1276|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||||0.1276
73915104|NCT02128113|147359635|SUPERIORITY||LS Mean difference (Net)|-11.08||||0.7996|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||||0.7996
73915105|NCT02128113|147359636|SUPERIORITY||Difference in proportion of patients|-13.55||||0.0647|TWO_SIDED|95.0|-26.75|-0.36|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||-0.36|-26.75|0.0647
73915106|NCT02128113|147359636|SUPERIORITY||Difference in proportion of patients|-15.15||||0.0517|TWO_SIDED|95.0|-28.34|-1.96|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||-1.96|-28.34|0.0517
73965853|NCT02412748|147467777|SUPERIORITY|||||||0.791|||||||ANCOVA|||||||.791
73965854|NCT02412748|147467778|SUPERIORITY|||||||0.583|||||||ANCOVA|||||||.583
73965855|NCT02412748|147467779|SUPERIORITY|||||||0.851|||||||ANCOVA|||||||.851
73965856|NCT00976937|147467848|SUPERIORITY_OR_OTHER||Response rate difference|4.6|STANDARD_ERROR_OF_MEAN|3.28||0.1696|TWO_SIDED|95.0|-1.84|11.0||Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata of screening HbA1c (\<8.0 or \>=8.0%) and randomization strata of screening BMI (\<35 or \>=35 kg/m\^2) was used.|Cochran-Mantel-Haenszel|||To demonstrate the superiority of lixisenatide over sitagliptin, 150 patients in each arm would provide a power of 90% with a 2-sided test at the 5% significance level, assuming the percentage of patients defined as responders on HbA1c (\<7%) and weight (at least 5% loss) is 25% with lixisenatide and 10% with sitagliptin.||11.00|-1.84|0.1696
73965857|NCT03069313|147467866|OTHER|Paired t-test|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
73965858|NCT03069313|147467867|OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
73965859|NCT03069313|147467868|OTHER|This analysis is comparing SWB before and after treatment.||||||0.133|||||||t-test, 2 sided|||||||0.133
73965860|NCT03069313|147467868|OTHER|||||||0.056|||||||t-test, 2 sided|||This analysis is comparing EWB before and after treatment.||||0.056
73915107|NCT02128113|147359637|SUPERIORITY||Difference in proportion of patients|-0.11||||0.9258|TWO_SIDED|95.0|-8.91|8.68|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||8.68|-8.91|0.9258
73915108|NCT02128113|147359637|SUPERIORITY||Difference in proportion of patients|-3.03||||0.6547|TWO_SIDED|95.0|-12.27|6.21|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||6.21|-12.27|0.6547
73915109|NCT02128113|147359638|SUPERIORITY||Difference in proportion of patients|-13.56||||0.0657|TWO_SIDED|95.0|-26.84|-0.28|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||-0.28|-26.84|0.0657
73915110|NCT02128113|147359638|SUPERIORITY|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution|Difference in proportion of patients|-15.15||||0.0526|TWO_SIDED|95.0|-28.42|-1.88|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|||-1.88|-28.42|0.0526
73915111|NCT02128113|147359639|SUPERIORITY||Difference in proportion of patients|0.0||||0.8771|TWO_SIDED|95.0|-10.87|10.87|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||10.87|-10.87|0.8771
73915112|NCT02128113|147359639|SUPERIORITY||Difference in proportion of patients|1.35||||0.8248|TWO_SIDED|95.0|-9.32|12.02|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||12.02|-9.32|0.8248
73915113|NCT02128113|147359640|SUPERIORITY||LS Mean difference (Net)|27.21||||0.4686|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension pooled (0.5% and 1.0%) versus Vehicle Ophthalmic Solution||||0.4686
73915114|NCT02128113|147359640|SUPERIORITY||LS Mean difference (Net)|49.99||||0.2636|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||||0.2636
73915115|NCT02128113|147359640|SUPERIORITY||LS Mean difference (Net)|-1.74||||0.9691|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||||0.9691
73915116|NCT02197247|147359671|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% confidence intervals (CIs) for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric least-squares (LS) mean ratio|27.16|||||TWO_SIDED|90.0|24.36|30.29|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed Css,max values were compared between periods using a mixed effects analysis of variance (ANOVA) with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both area under the plasma concentration-time curve during the dosing interval (AUCtau) and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.||30.29|24.36|
73915117|NCT02197247|147359672|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% CIs for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric LS Mean Ratio|21.55|||||TWO_SIDED|90.0|19.5|23.83|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both AUCtau and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.||23.83|19.50|
73915118|NCT02197247|147359673|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|95.53|||||TWO_SIDED|90.0|85.27|107.03|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||107.03|85.27|
73915119|NCT02197247|147359674|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|21.72|||||TWO_SIDED|90.0|19.08|24.72|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||24.72|19.08|
73915120|NCT02197247|147359674|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|88.31|||||TWO_SIDED|90.0|77.17|101.07|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||101.07|77.17|
73915121|NCT02197247|147359675|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|139.32|||||TWO_SIDED|90.0|127.74|151.96|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||151.96|127.74|
73915122|NCT02197247|147359675|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|100.75|||||TWO_SIDED|90.0|92.04|110.29|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||110.29|92.04|
73965861|NCT03069313|147467868|OTHER||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing PWB before and after treatment.||||<0.0001
73965862|NCT03069313|147467868|OTHER|||||||0.09|||||||t-test, 2 sided|||This analysis is comparing FWB before and after treatment.||||0.09
73965863|NCT03069313|147467868|OTHER||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing ESS before and after treatment.||||<0.0001
73915123|NCT02197247|147359677|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|95.89|||||TWO_SIDED|90.0|86.37|106.45|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||106.45|86.37|
73915124|NCT02197247|147359678|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|18.76|||||TWO_SIDED|90.0|16.61|21.19|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||21.19|16.61|
73915125|NCT02197247|147359678|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|90.08|||||TWO_SIDED|90.0|79.34|102.27|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||102.27|79.34|
73915126|NCT02197247|147359679|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|129.81|||||TWO_SIDED|90.0|119.14|141.44|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||141.44|119.14|
73915127|NCT02197247|147359679|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|100.76|||||TWO_SIDED|90.0|92.15|110.19|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||110.19|92.15|
73915128|NCT01288235|147359707|OTHER||3-Year Cumulative incidence|14.5|||||TWO_SIDED|95.0|8.3|22.3||||||||22.3|8.3|
73915129|NCT01288235|147359707|OTHER||5-Year Cumulative incidence|20.2|||||TWO_SIDED|95.0|12.7|28.9||||||||28.9|12.7|
73965864|NCT01872078|147467891|SUPERIORITY_OR_OTHER||Ratio (%)|87.04|||||TWO_SIDED|95.0|58.52|129.47||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||129.47|58.52|
73965865|NCT01872078|147467891|SUPERIORITY_OR_OTHER||Ratio (%)|78.76|||||TWO_SIDED|95.0|53.41|116.16||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||116.16|53.41|
73965866|NCT01872078|147467891|SUPERIORITY_OR_OTHER||Ratio (%)|47.99|||||TWO_SIDED|95.0|32.73|70.36||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||70.36|32.73|
73965867|NCT01424670|147467892|SUPERIORITY|||||||0.0562||||||For testing the null hypothesis, the distribution of the time to SCC within the 6-month Intensive Period were compared between the 2 treatment groups using the stratified modified Peto-Peto modification of Gehan's Wilcoxon rank sum test.|Modified Peto-Peto test|||Comparison of distributions of time to SCC using the MGIT culture system during the 6-month (26-week) Intensive Period.||||0.0562
73915130|NCT01288235|147359708|OTHER||Mean Difference (Net)|1.1||||0.543|TWO_SIDED|95.0|-2.6|4.9|||t-test, 2 sided|Paired t test||||4.9|-2.6|0.543
73915131|NCT01288235|147359709|OTHER||3-Year Local Disease Control Probability|89.9|||||TWO_SIDED|95.0|83.1|94.9||||||||94.9|83.1|
73915132|NCT01288235|147359709|OTHER||5-Year Local Disease Control Probability|85.9|||||TWO_SIDED|95.0|78.2|91.9||||||||91.9|78.2|
73915133|NCT01288235|147359709|OTHER||3-Year Distant Disease Control|97.0|||||TWO_SIDED|95.0|92.1|99.2||||||||99.2|92.1|
73915134|NCT01288235|147359709|OTHER||5-Year Distant Disease Control|95.0|||||TWO_SIDED|95.0|89.4|98.1||||||||98.1|89.4|
73915135|NCT01288235|147359710|OTHER||3-Year Cumulative incidence of grade 3+|12.2|||||TWO_SIDED|95.0|6.6|19.5||||||||19.5|6.6|
73915136|NCT01288235|147359710|OTHER||5-Year Cumulative incidence of grade 3+|16.3|||||TWO_SIDED|95.0|9.8|24.3||||||||24.3|9.8|
73915137|NCT01288235|147359711|OTHER||3-Year Cumulative inc. of hearing loss|12.5|||||TWO_SIDED|95.0|2.9|29.5||||||||29.5|2.9|
73915138|NCT01288235|147359711|OTHER||5-Year Cumulative inc. of hearing loss|12.5|||||TWO_SIDED|95.0|2.9|29.5||||||||29.5|2.9|
73965868|NCT01424670|147467893|SUPERIORITY|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.096||||0.3818|TWO_SIDED|95.0|0.889|1.352|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 2 months.||1.352|0.889|0.3818
73965869|NCT01424670|147467893|SUPERIORITY|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.017||||0.7131|TWO_SIDED|95.0|0.927|1.115|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 6 months.||1.115|0.927|0.7131
73965870|NCT01424670|147467894|SUPERIORITY||Relative Ratio of Probability|0.969||||0.5945|TWO_SIDED|95.0|0.866|1.084|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 18.||1.084|0.866|0.5945
73965871|NCT01424670|147467894|SUPERIORITY||Relative Ratio of Probability|0.97||||0.6164|TWO_SIDED|95.0|0.864|1.089|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 24.||1.089|0.864|0.6164
73965872|NCT01424670|147467894|SUPERIORITY||Relative Ratio of Probability|0.991||||0.8951|TWO_SIDED|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 30.||1.127|0.872|0.8951
73965873|NCT01424670|147467895|SUPERIORITY||Relative Ratio of Probability|0.965||||0.5269|TWO_SIDED|95.0|0.869|1.073|||Cochran-Mantel-Haenszel|||Statistical comparison of proportions with favorable treatment outcomes assessed by the Principal Investigator.||1.073|0.869|0.5269
73965874|NCT01424670|147467897|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.6986|TWO_SIDED|95.0|-1.9|1.3|||ANCOVA|||Statistical comparison of mean AUC of change from Baseline.||1.3|-1.9|0.6986
73965875|NCT01424670|147467898|SUPERIORITY|||||||0.6825|||||||ANCOVA|||Statistical analysis for Week 1.||||0.6825
73965876|NCT01424670|147467898|SUPERIORITY|||||||0.807|||||||ANCOVA|||Statistical analysis for Week 2.||||0.807
73965877|NCT01424670|147467898|SUPERIORITY|||||||0.269|||||||ANCOVA|||Statistical analysis for Week 3.||||0.269
73965878|NCT01424670|147467898|SUPERIORITY|||||||0.2333|||||||ANCOVA|||Statistical analysis for Week 24.||||0.2333
74085838|NCT02630316|147725874|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73859741|NCT01062841|147265633|SUPERIORITY_OR_OTHER||Rate Ratio|1.2|||>|0.05|TWO_SIDED|95.0|0.82|1.75||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||1.75|0.82|>0.05
73859742|NCT01062841|147265634|SUPERIORITY_OR_OTHER||Rate Ratio|0.94|||>|0.05|TWO_SIDED|95.0|0.61|1.44||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||1.44|0.61|>0.05
73859743|NCT01062841|147265635|SUPERIORITY_OR_OTHER||Rate Ratio|0.75|||<|0.05|TWO_SIDED|95.0|0.58|0.97||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.97|0.58|<0.05
73859744|NCT01062841|147265637|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.09||||0.92|TWO_SIDED|95.0|0.22|5.45|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||5.45|0.22|0.92
73859745|NCT01062841|147265638|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.83||||0.34|TWO_SIDED|95.0|0.53|6.31|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||6.31|0.53|0.34
73859746|NCT01062841|147265639|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.78||||0.01|TWO_SIDED|95.0|0.65|0.95|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.||0.95|0.65|0.01
73859747|NCT01062841|147265640|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.85||||0.61|TWO_SIDED|95.0|0.45|1.6|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.||1.60|0.45|0.61
73859748|NCT01062841|147265641|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.59|TWO_SIDED|95.0|0.6|1.33|||Regression, Cox|||||1.33|0.60|0.59
73859749|NCT01187004|147265653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Regression, Logistic|significant level for inclusion at the univariate analysis was p\<0.05.||Our hypothesis was that mechanical ventilation with large tidal volume might represent a risk factor for acute lung injury in patients undergoing cardiopulmonary bypass.||||<0.05
73859750|NCT01187004|147265654|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.199|||<|0.001|TWO_SIDED|95.0|1.129|1.272|||Wilcoxon (Mann-Whitney)|||||1.272|1.129|<0.001
73859751|NCT02446418|147265660|NON_INFERIORITY|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.8||||0.033|TWO_SIDED|95.0|0.1|1.5|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6 and Week 12), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by-visit interaction, gender, age, country and participant fitted as a random factor. The Restricted Maximum Likelihood (REML) estimation approach was used with a default covariance structure of unstructured.|1.5|0.1|0.033
73859752|NCT02446418|147265661|NON_INFERIORITY|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.4||||0.224|TWO_SIDED|95.0|-0.3|1.1|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6, Week 12, Week 18 and Week 24), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by visit interaction, gender, age, country and participant fitted as a random factor. The REML estimation approach was used with a default covariance structure of unstructured.|1.1|-0.3|0.224
73859753|NCT02446418|147265662|SUPERIORITY||Adjusted Odds Ratio|1.11||||0.82|TWO_SIDED|95.0|0.47|2.62|||Regression, Logistic|||Week 12|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.|2.62|0.47|0.820
73915139|NCT01930123|147359712|OTHER||Mean Difference (Final Values)|6.26|STANDARD_DEVIATION|9.98||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.01
73915140|NCT01930123|147359713|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Mild fibrosis vs. advanced fibrosis||||0.006
73915141|NCT01930123|147359714|OTHER||Median Difference (Final Values)|56.7|STANDARD_DEVIATION|2.6||0.09|TWO_SIDED||||||t-test, 1 sided|||||||0.09
73915142|NCT01447433|147359721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.439|STANDARD_ERROR_OF_MEAN|0.56||0.441|TWO_SIDED|95.0|-0.7|1.58|||t-test, 2 sided|||||1.58|-0.70|0.441
73915143|NCT01447433|147359722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88|STANDARD_ERROR_OF_MEAN|0.41||0.038|TWO_SIDED|95.0|0.05|1.7|||t-test, 2 sided|||Body Fat Mass||1.70|0.05|0.038
73915144|NCT01447433|147359722|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.082|TWO_SIDED|95.0|-1.06|0.07|||t-test, 2 sided|||Body Lean Mass||0.07|-1.06|0.082
73915145|NCT01447433|147359722|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.32|||t-test, 2 sided|||Visceral Fat Mass||0.32|0.03|0.018
73915146|NCT01447433|147359723|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.49||0.031|TWO_SIDED|95.0|0.1|2.09|||t-test, 2 sided|||||2.09|0.10|0.031
73915147|NCT01447433|147359724|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.72|STANDARD_ERROR_OF_MEAN|2.25||0.016|TWO_SIDED|95.0|1.15|10.29|||t-test, 2 sided|||||10.29|1.15|0.016
73915148|NCT01447433|147359725|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.14|STANDARD_ERROR_OF_MEAN|1.7||0.508|TWO_SIDED|95.0|-2.31|4.58|||t-test, 2 sided|||Waist Circumference||4.58|-2.31|0.508
73915149|NCT01447433|147359725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|2.07||0.56|TWO_SIDED|95.0|-5.42|2.98|||t-test, 2 sided|||Abdominal Circumference||2.98|-5.42|0.560
73915150|NCT01447433|147359725|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|0.85||0.255|TWO_SIDED|95.0|-0.74|2.7|||t-test, 2 sided|||Hip Circumference||2.70|-0.74|0.255
73915151|NCT01447433|147359726|SUPERIORITY_OR_OTHER||Median Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|4.5||0.404|TWO_SIDED|95.0|-12.9|5.3|||t-test, 2 sided|||Systolic Blood Pressure||5.3|-12.9|0.404
73915152|NCT01447433|147359726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|3.18||0.768|TWO_SIDED|95.0|-5.52|7.41|||t-test, 2 sided|||Diastolic Blood Pressure||7.41|-5.52|0.768
73965879|NCT01424670|147467898|SUPERIORITY|||||||0.9397|||||||ANCOVA|||Statistical analysis for Month 6.||||0.9397
73965880|NCT01424670|147467899|SUPERIORITY||Relative Ratio of Probability|0.991||||0.8951|TWO_SIDED|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with treatment success at Month 30.||1.127|0.872|0.8951
74027117|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.54|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.70|0.54|
74027118|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.59|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.41|0.59|
73915153|NCT01447433|147359727|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.565|TWO_SIDED|95.0|-0.36|0.2|||t-test, 2 sided|||TC||0.20|-0.36|0.565
73915154|NCT01447433|147359727|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.15||0.636|TWO_SIDED|95.0|-0.24|0.39|||t-test, 2 sided|||TG||0.39|-0.24|0.636
73915155|NCT01447433|147359727|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.112|TWO_SIDED|95.0|-0.58|0.06|||t-test, 2 sided|||HDL||0.06|-0.58|0.112
73915156|NCT01447433|147359727|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.647|TWO_SIDED|95.0|-0.11|0.05|||t-test, 2 sided|||LDL||0.05|-0.11|0.647
73915157|NCT01447433|147359728|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.26|TWO_SIDED|95.0|-0.1|0.35|||t-test, 2 sided|||||0.35|-0.10|0.260
73915158|NCT01447433|147359729|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|1.63||0.598|TWO_SIDED|95.0|-2.44|4.17|||t-test, 2 sided|||||4.17|-2.44|0.598
73915159|NCT01447433|147359730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|98.5|STANDARD_ERROR_OF_MEAN|89.0||0.275|TWO_SIDED|95.0|-81.6|278.7|||t-test, 2 sided|||||278.7|-81.6|0.275
73915160|NCT00036270|147359731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.118|TWO_SIDED|95.0|0.77|1.03|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 2.75 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 2.75 years.~To maintain overall alpha of 0.05, 2 adjustments made: first, a nominal alpha of 0.0302 was used for the primary endpoint. Second, level of significant was 0.0012 for interim analysis."||1.03|0.77|0.118
73915161|NCT00036270|147359732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.604|TWO_SIDED|95.0|0.88|1.08|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 5 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 5 years.~To maintain overall alpha of 0.05, a nominal alpha of 0.0302 was used."||1.08|0.88|0.604
73965881|NCT00709098|147467954|SUPERIORITY_OR_OTHER||Mean group difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.0|-3.1|||t-test, 2 sided|||||-3.1|-7.0|<0.0001
73965882|NCT01227265|147467955|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.2||||0.4933|TWO_SIDED|95.0|-0.72|0.35|||cLDA|||||0.35|-0.72|0.4933
73965883|NCT01227265|147467955|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.3||||0.2364|TWO_SIDED|95.0|-0.86|0.21|||cLDA|||||0.21|-0.86|0.2364
73965884|NCT01227265|147467956|SUPERIORITY_OR_OTHER||Estimated Difference in Percentage|7.0||||0.244|TWO_SIDED|95.0|-4.17|18.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis|||||18.05|-4.17|0.244
73965885|NCT01227265|147467956|SUPERIORITY_OR_OTHER||Estimated Difference in Percentage|6.5||||0.262|TWO_SIDED|95.0|-4.63|17.61||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis|||||17.61|-4.63|0.262
73965886|NCT01227265|147467957|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.776|TWO_SIDED|95.0|-0.47|0.63|||cLDA|||||0.63|-0.47|0.776
73965887|NCT01227265|147467957|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.683|TWO_SIDED|95.0|-0.44|0.67|||cLDA|||||0.67|-0.44|0.683
73915162|NCT00036270|147359733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.951|TWO_SIDED|95.0|0.89|1.14|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in OS between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.||1.14|0.89|0.951
73915163|NCT00036270|147359735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.293|TWO_SIDED|95.0|0.83|1.06|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in time to relapse between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.||1.06|0.83|0.293
73915164|NCT01964430|147359737|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1824|TWO_SIDED|95.0|0.729|1.063|||Log Rank|Stratified by resection status (R0 versus R1) and nodal status (LN+ versus LN).|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus LN-).|||1.063|0.729|0.1824
73915165|NCT01964430|147359738|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0128|TWO_SIDED|95.0|0.691|0.957|||Log Rank|Stratified by resection status (R0 versus. R1) and nodal status (LN+ versus. LN-)|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus|||0.957|0.691|0.0128
73915166|NCT02446483|147359746|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|101.32|||||TWO_SIDED|90.0|95.81|107.15||||||||107.15|95.81|
73915167|NCT02446483|147359747|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.71|||||TWO_SIDED|90.0|92.54|105.28||||||Comparison of T- rabeprazole 20 mg and R- rabeprazole 20 mg for AUC0-t.||105.28|92.54|
73915168|NCT02446483|147359747|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.05|||||TWO_SIDED|90.0|91.81|104.71||||||Comparison of Treatment A- rabeprazole 20 mg and Treatment B- rabeprazole 20 mg for AUC0-infinity.||104.71|91.81|
73915169|NCT02446483|147359748|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||Wilcoxon's Signed-Rank Test|||||||0.0029
73915170|NCT02557555|147359778|OTHER|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Researched options for labor pain|Test of equal proportion (50/50)|||||||<0.0001
73915171|NCT02557555|147359778|OTHER|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Pamphlet better explained options for pain|Test of equal proportion (50/50)|||||||<0.0001
73915172|NCT02557555|147359778|OTHER||||||<|0.0001||||||Pamphlet should be given before onset labor pain|Test of equal proportion (50/50)|||||||<0.0001
73915173|NCT02557555|147359778|OTHER||||||<|0.0001||||||Pamphlet information helped to reduce anxiety|Test of equal proportion (50/50)|||||||<0.0001
73915174|NCT02557555|147359778|OTHER|||||||0.0002||||||Information corrected any misconception|Test of equal proportion (50/50)|||||||0.0002
73915175|NCT02557555|147359778|OTHER||||||<|0.0001||||||Written information should always be available|Test of equal proportion (50/50)|||||||<0.0001
73915176|NCT00291577|147359780|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.89||||||90.0|80.34|121.73|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3. Due to the exploratory nature of the study, no statistical hypothesis testing was done since the primary purpose was to assess the tolerability of the combination of SU011248 with docetaxel.||121.73|80.34|
73915177|NCT00291577|147359780|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|81.96||||||90.0|59.76|112.41|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3||112.41|59.76|
73915178|NCT00291577|147359780|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|97.81||||||90.0|80.44|118.94|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3||118.94|80.44|
73915179|NCT00291577|147359781|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|101.23||||||90.0|82.75|123.83|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3||123.83|82.75|
73915180|NCT00291577|147359781|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|81.72||||||90.0|62.4|107.04|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3||107.04|62.40|
73915181|NCT00291577|147359781|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.0||||||90.0|82.95|120.56|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3||120.56|82.95|
73915182|NCT00291577|147359785|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|99.18||||||90.0|78.73|124.95|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||124.95|78.73|
73915183|NCT00291577|147359786|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|94.98||||||90.0|78.73|114.58|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.58|78.73|
73915184|NCT00291577|147359788|SUPERIORITY_OR_OTHER||rate (percent)|73.7||||||95.0|48.8|90.9|||||Two-sided Confidence Interval (CI) (%) from exact method based on F distribution.|Overall confirmed objective response rate (CR + PR)||90.9|48.8|
73915185|NCT00291577|147359789|SUPERIORITY_OR_OTHER||rate (percent)|89.5||||||95.0|66.9|98.7|||||Two-sided CI (%) from exact method based on F distribution.|Clinical Benefit Rate (CR + PR + SD \> = 24 weeks)||98.7|66.9|
73915186|NCT00291577|147359791|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.57||||||90.0|79.9|114.32|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.32|79.90|
73965888|NCT01227265|147467961|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.2||||0.6968|TWO_SIDED|95.0|-0.92|0.61|||cLDA|||||0.61|-0.92|0.6968
73965889|NCT01227265|147467961|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.2||||0.6142|TWO_SIDED|95.0|-0.57|0.97|||cLDA|||||0.97|-0.57|0.6142
73965890|NCT03690206|147468000|SUPERIORITY||Difference to Placebo|-2.28||||0.0039|TWO_SIDED|95.0|-3.83|-0.73|||Mixed Models Analysis|||||-0.73|-3.83|0.0039
73965891|NCT03690206|147468000|SUPERIORITY||Difference to Placebo|-0.91||||0.27|TWO_SIDED|95.0|-2.52|0.71|||Mixed Models Analysis|||||0.71|-2.52|0.2700
74085839|NCT02630316|147725875|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.041|TWO_SIDED|95.0|0.4|0.92||p-value is calculated with log-rank test stratified by baseline 6MWD category.|Log Rank||p-value was 0.0202 for the proportional hazard model. Hazard ratio, 95% confidence interval (CI), and p-values are calculated with proportional hazards model with treatment and Baseline 6MWD (continuous) as explanatory variables.|||0.92|0.40|0.0410
74085840|NCT02630316|147725876|SUPERIORITY||Hodges-Lehmann|20.0||||0.0041|TWO_SIDED|95.0|7.0|34.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category|ANCOVA|||||34.0|7.0|0.0041
74085841|NCT02630316|147725877|SUPERIORITY||Hodges-Lehmann|15.0||||0.0432|TWO_SIDED|95.0|0.0|29.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category.|ANCOVA|||||29.0|0.0|0.0432
74085842|NCT00476593|147725884|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|95.0||||Hypothesis: the use of diclofenac/dexamethasone does not influence macular thickness in treated eyes compared with untreated eyes of same subject.|t-test, 2 sided|The possible effect of both anti-inflammatory medications was tested in relation to participants' age and gender||Subjects who received diclofenac or dexamethasone eye drops in one eye. Macular thickness in both were compared between same subjects' eyes after 3 day's treatment. Diclofenac and dexamethasone treated eyes were not compared with each other, but with the contralateral eye of same subject by a paired Student's t-test in each medication group||||0.018
74085843|NCT00476593|147725884|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|95.0|||||t-test, 2 sided|||Patient's healthy eyes were compared with sex and age matched healthy controls with Two Sample Student't t-test. Null hypothesis was that quiet, currently unaffected eyes of patients had same macular thickness as age and sex matched controls.||||0.024
73915187|NCT00291577|147359792|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|112.39||||||90.0|81.05|155.85|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||155.85|81.05|
73915188|NCT00291577|147359793|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.79||||||90.0|79.82|114.96|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.96|79.82|
73965892|NCT03690206|147468001|SUPERIORITY||Difference to Placebo|26.6||||0.0243|TWO_SIDED|95.0|4.3|48.9|||Cochran-Mantel-Haenszel|||||48.9|4.3|0.0243
73965893|NCT03690206|147468001|SUPERIORITY||Difference to Placebo|5.5||||0.6255|TWO_SIDED|95.0|-16.2|27.1|||Cochran-Mantel-Haenszel|||||27.1|-16.2|0.6255
73965894|NCT03690206|147468002|SUPERIORITY||Difference to Placebo|31.7||||0.0043|TWO_SIDED|95.0|11.4|51.9|||Cochran-Mantel-Haenszel|||||51.9|11.4|0.0043
73965895|NCT03690206|147468002|SUPERIORITY||Difference to Placebo|13.3||||0.1675|TWO_SIDED|95.0|-5.4|32.0|||Cochran-Mantel-Haenszel|||||32.0|-5.4|0.1675
73965896|NCT03690206|147468004|SUPERIORITY||Difference to Placebo|14.1||||0.016|TWO_SIDED|95.0|2.5|25.6|||Cochran-Mantel-Haenszel|||||25.6|2.5|0.0160
73965897|NCT03690206|147468004|SUPERIORITY||Difference to Placebo|11.2||||0.0424|TWO_SIDED|95.0|0.7|21.6|||Cochran-Mantel-Haenszel|||||21.6|0.7|0.0424
73965898|NCT05028582|147468032|SUPERIORITY||Odds Ratio, log|5.19|||<|0.0001|TWO_SIDED|97.5|2.9|9.31|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|S-IGA Success at Week 8||9.31|2.90|<0.0001
73965899|NCT05028582|147468033|SUPERIORITY||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|97.5|1.75|5.73|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|B-IGA Success at Week 8||5.73|1.75|<0.0001
73965900|NCT05028582|147468034|OTHER|SI-NRS Success at Week 4|Odds Ratio (OR)|4.67||||0.0005|TWO_SIDED|97.5|1.6|13.62|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|||13.62|1.60|0.0005
73965901|NCT05028582|147468035|SUPERIORITY||Odds Ratio (OR)|4.39|||<|0.0001|TWO_SIDED|97.5|2.01|9.55|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|SI-NRS Success at Week 4||9.55|2.01|<0.0001
73965902|NCT05028582|147468036|OTHER|SI-NRS Success at Week 8|Odds Ratio (OR)|5.41|||<|0.0001|TWO_SIDED|97.5|2.49|11.78|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|||11.78|2.49|<0.0001
73965903|NCT05028582|147468037|SUPERIORITY|SI-NRS Change from Baseline Day 1|LS Mean Difference|-0.35||||0.0164|TWO_SIDED|97.5|-0.68|-0.02|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.02|-0.68|0.0164
73965904|NCT05028582|147468038|SUPERIORITY|SI-NRS Change from Baseline Day 1|LS Mean Difference|-0.76|||<|0.0001|TWO_SIDED|97.5|-1.12|-0.39|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.39|-1.12|<0.0001
73965905|NCT05028582|147468039|SUPERIORITY|Change from Baseline in Weekly SI-NRS at Week 1|LS Mean Difference|-0.55||||0.0002|TWO_SIDED|97.5|-0.87|-0.22|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.22|-0.87|0.0002
73965906|NCT05028582|147468040|OTHER|WI-NRS Success at Week 8|Odds Ratio (OR)|4.14|||<|0.0001|TWO_SIDED|97.5|2.01|8.52|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|||8.52|2.01|<0.0001
73965907|NCT05028582|147468041|SUPERIORITY|PASI-75 at Week 8|Odds Ratio (OR)|5.42|||<|0.0001|TWO_SIDED|97.5|2.73|10.75|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||10.75|2.73|<0.0001
73915189|NCT04659161|147359868|SUPERIORITY||LS mean difference|-9.6|||<|0.0001|TWO_SIDED|95.0|-13.9|-5.2|||Mixed Model for Repeated Measures||||Statistics are from a mixed model for repeated measures (MMRM). The model includes the treatment group (KarXT or placebo), visit, and the interaction between the treatment group and visit as fixed factors, and baseline PANSS total score, site, age, and gender as covariates. An unstructured covariance matrix is used to model the correlation among repeated measurements and the denominator degrees of freedom are computed using the Kenward-Roger method.|-5.2|-13.9|<0.0001
73915190|NCT04659161|147359869|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
73915191|NCT04659161|147359870|SUPERIORITY|||||||0.0055|||||||Mixed Model Repeated Measures|||||||0.0055
73915192|NCT04659161|147359871|SUPERIORITY|||||||0.0022|||||||Mixed Model for Repeated Measures|||||||0.0022
73915193|NCT04659161|147359872|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
73915194|NCT04659161|147359873|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
74085844|NCT00559364|147725887|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Analysis of covariance (ANCOVA) model using treatment group and pooled site as fixed effects and wash-out phase CFA% value as covariate was used.||||<0.0001
74085845|NCT00330460|147725894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.22%.|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.7|1.2|||ANCOVA|||||1.2|0.7|<0.0001
73915195|NCT02197130|147359883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.192||0.2033|TWO_SIDED|90.0|-0.45|3.49|||MMRM|MMRM: A linear mixed-effect repeated measures model||||3.49|-0.45|0.2033
73915196|NCT02197130|147359883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|1.118||0.7549|TWO_SIDED|90.0|-2.2|1.5|||MMRM|||||1.50|-2.20|0.7549
73915197|NCT02197130|147359895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|0.515||0.003|TWO_SIDED|90.0|0.69|2.39|||MMRM|||Week 13||2.39|0.69|0.0030
73915198|NCT02197130|147359895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.491||0.4656|TWO_SIDED|90.0|-0.45|1.17|||MMRM|||Week 13||1.17|-0.45|0.4656
73915199|NCT02197130|147359895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.21|STANDARD_ERROR_OF_MEAN|0.492||0.0149|TWO_SIDED|90.0|0.39|2.02|||MMRM|||Week 26||2.02|0.39|0.0149
73915200|NCT02197130|147359895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8233|TWO_SIDED|90.0|-0.66|0.86|||MMRM|||Week 26||0.86|-0.66|0.8233
73915201|NCT02197130|147359897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.148||0.0181|TWO_SIDED|90.0|0.11|0.6|||MMRM|||Week 13||0.60|0.11|0.0181
73915202|NCT02197130|147359897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7133|TWO_SIDED|90.0|-0.18|0.28|||MMRM|||Week 13||0.28|-0.18|0.7133
73915203|NCT02197130|147359897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.163||0.4657|TWO_SIDED|90.0|-0.15|0.39|||MMRM|||Week 26||0.39|-0.15|0.4657
73915204|NCT02197130|147359897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.15||0.8339|TWO_SIDED|90.0|-0.22|0.28|||MMRM|||Week 26||0.28|-0.22|0.8339
73915205|NCT02320669|147359902|SUPERIORITY||Cox Proportional Hazard|1.083|||<|0.05|TWO_SIDED|95.0|0.82|1.432|||Regression, Cox|||||1.432|.82|<.05
73915206|NCT03338998|147359913|SUPERIORITY||Geo-mean ratio|1.05||||0.585|TWO_SIDED|90.0|0.717|1.535|||ANCOVA|||||1.535|0.717|0.585
73915207|NCT01372462|147359915|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||The primary endpoint was difference in endurance between nasal cannula oxygen and NIOV+O2. Assuming 153 sec clinically important difference, 183 sec SD, and α=0.05, a sample size of 15 yielded 85% power.||||<0.05
73915208|NCT01372462|147359915|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73915209|NCT01372462|147359915|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73915210|NCT01372462|147359916|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons test||||< 0.05
73915211|NCT01372462|147359916|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73915212|NCT01372462|147359916|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73915213|NCT01372462|147359917|SUPERIORITY_OR_OTHER||||||<|0.05||||||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons tests|ANOVA|Newman-Keuls multiple comparisons tests||Per protocol||||<0.05
73915214|NCT01372462|147359917|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73915215|NCT01372462|147359917|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73915216|NCT05231954|147359943|SUPERIORITY||Odds Ratio (OR)|1.29||||0.006|TWO_SIDED|95.0|1.08|1.55||P-value is adjusted for multiple comparisons, and a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.55|1.08|0.006
73915217|NCT05231954|147359943|SUPERIORITY||Odds Ratio (OR)|0.82||||0.081|TWO_SIDED|95.0|0.65|1.03||The p-value is adjusted for multiple comparisons, and a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.03|0.65|0.081
73915218|NCT05231954|147359944|SUPERIORITY||Odds Ratio (OR)|1.44||||0.044|TWO_SIDED|95.0|1.01|2.05||The p-value is adjusted for multiple comparisons, and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||2.05|1.01|0.044
73915219|NCT05231954|147359944|SUPERIORITY||Odds Ratio (OR)|1.02||||0.919|TWO_SIDED|95.0|0.69|1.5||The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.50|0.69|0.919
73915220|NCT00980057|147359959|NON_INFERIORITY|The non-inferiority margin was 12%.||||||0.0002|||||||Farrington-Manning test of two ind. prop|||||||0.0002
73915221|NCT00980057|147359960|SUPERIORITY|The pre-specified minimum objective performance criteria was 0.82|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
73915222|NCT00980057|147359962|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73915223|NCT00980057|147359963|NON_INFERIORITY|The non-inferiority margin is 15|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
73915224|NCT00980057|147359964|NON_INFERIORITY|The non-inferiority margin is 2.5||||||0.0009|||||||t-test, 1 sided|||||||0.0009
73915225|NCT00980057|147359965|NON_INFERIORITY|The non-inferiority margin is 0.3|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
73915226|NCT00980057|147359966|NON_INFERIORITY|The non-inferiority margin is 30||||||0.0002|||||||t-test, 1 sided|||||||0.0002
73915227|NCT00980057|147359967|NON_INFERIORITY|The non-inferiority margin is 5.1||||||0.002|||||||t-test, 1 sided|||||||0.002
73915228|NCT01315678|147359976|SUPERIORITY||Cox Proportional Hazard|1.51||||0.0286|TWO_SIDED|95.0|1.07|2.13|||Regression, Cox|||Stratified Cox proportional hazards model||2.13|1.07|0.0286
73915229|NCT01315678|147359977|SUPERIORITY||Cox Proportional Hazard|1.12||||0.6031|TWO_SIDED|95.0|0.76|1.66|||Regression, Cox|||||1.66|0.76|0.6031
73915230|NCT01315678|147359978|SUPERIORITY||Cox Proportional Hazard|0.84||||0.4861|TWO_SIDED|95.0|0.49|1.44|||Regression, Cox|||||1.44|0.49|0.4861
73915231|NCT00790023|147359984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.0001|TWO_SIDED|95.0|0.57|1.32||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.32|0.57|<0.0001
73915232|NCT00790023|147359984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.0001|TWO_SIDED|95.0|0.7|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.45|0.70|<0.0001
73915233|NCT00790023|147359985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.5|1.25|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||1.25|0.50|<0.0001
73965908|NCT05028582|147468042|SUPERIORITY|PSD Aggregate Score Change at Week 8|LS Mean Difference|-5.12|||<|0.0001|TWO_SIDED|97.5|-6.64|-3.6|||ANCOVA|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA and baseline PSD aggregate score \& multiple imputation of missing data|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA and baseline PSD aggregate score \& multiple imputation of missing data|||-3.60|-6.64|<0.0001
73915234|NCT00790023|147359985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.0001|TWO_SIDED|95.0|0.63|1.37|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||1.37|0.63|<0.0001
73915235|NCT00790023|147359986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.0004|TWO_SIDED|95.0|0.28|0.95|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.95|0.28|0.0004
73915236|NCT00790023|147359986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.0005|TWO_SIDED|95.0|0.27|0.94|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.94|0.27|0.0005
73915237|NCT00004978|147360021|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.55|TWO_SIDED|95.0|0.75|1.16||P-value is 2-sided using an alpha of .05.|Regression, Cox|Hazard ratio is from unadjusted proportional hazards regression model.|HR is for rIL-2 vs control.|||1.16|0.75|.55
73915238|NCT00004978|147360022|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.62|TWO_SIDED|95.0|0.74|1.2|||Regression, Cox|||||1.20|0.74|.62
73965909|NCT05028582|147468043|SUPERIORITY|PSD Itching Week 8|Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|97.5|2.1|10.04|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||10.04|2.10|<0.0001
73965910|NCT05028582|147468044|SUPERIORITY|PSD Pain Week 8|Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|97.5|1.83|5.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||5.68|1.83|<0.0001
73965911|NCT05028582|147468045|SUPERIORITY|PSD Scaling Week 8|Odds Ratio (OR)|4.56|||<|0.0001|TWO_SIDED|97.5|2.28|9.08|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||9.08|2.28|<0.0001
73915239|NCT00004978|147360023|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.42|TWO_SIDED|95.0|0.69|1.17|||Regression, Cox|||||1.17|0.69|.42
73965912|NCT05028582|147468046|OTHER|PSD Total Score 0 at Week 8|Odds Ratio (OR)|3.27||||0.0012|TWO_SIDED|97.5|1.39|7.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|||7.68|1.39|0.0012
73915240|NCT00004978|147360024|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.41|TWO_SIDED|95.0|0.73|1.14|||Regression, Cox|||||1.14|0.73|.41
73915241|NCT00004978|147360025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|159.0|||||TWO_SIDED|95.0|145.0|174.0|||||treatment difference (rIL2 - no rIL2) estimated from a longitudinal model that considers CD4+ measured at followup visits|||174|145|
73915242|NCT00004978|147360027|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.07|TWO_SIDED|95.0|0.88|1.0|||Regression, Cox|Hazard ratio (rIL-2 vs. no rIL-2) for first change in antiretroviral treatment.||||1.00|0.88|.07
73915243|NCT00004978|147360028|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.003|TWO_SIDED|95.0|1.07|1.41|||Regression, Cox||HR (IL-2 vs control) for first grade 4 event, ITT analysis.|||1.41|1.07|.003
73915244|NCT00004978|147360029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||95.0|||||Chi-squared|||||||.97
73915245|NCT00004978|147360030|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.74|TWO_SIDED|95.0|0.76|1.22|||Regression, Cox|||||1.22|0.76|.74
73965913|NCT05028582|147468047|SUPERIORITY|PSSI-75 at Week 8|Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|97.5|2.98|9.77|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B IGA with multiple imputation to handle missing data|||9.77|2.98|<0.0001
73965914|NCT05028582|147468048|SUPERIORITY|S-IGA Clear at Week 8|Odds Ratio (OR)|6.77|||<|0.0001|TWO_SIDED|97.5|3.04|15.05|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||15.05|3.04|<0.0001
73915246|NCT01652703|147360035|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.61|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-74.51|-62.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-62.71|-74.51|<0.001
73915247|NCT01652703|147360035|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.85|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-58.84|-46.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-46.86|-58.84|<0.001
73915248|NCT01652703|147360035|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.94|STANDARD_ERROR_OF_MEAN|3.18|<|0.001|TWO_SIDED|95.0|-70.23|-57.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-57.66|-70.23|<0.001
73915249|NCT01652703|147360035|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-58.16|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-64.51|-51.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.81|-64.51|<0.001
73965915|NCT05028582|147468049|SUPERIORITY|S-IGA Success Week 2|Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|97.5|1.84|9.13|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||9.13|1.84|<0.0001
73965916|NCT05028582|147468050|SUPERIORITY|S-IGA Success at Week 4|Odds Ratio (OR)|4.82|||<|0.0001|TWO_SIDED|97.5|2.62|8.84|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||8.84|2.62|<0.0001
73965917|NCT05028582|147468051|SUPERIORITY|Change from Baseline in PASI Week 2|LS Mean Difference|-1.28|||<|0.0001|TWO_SIDED|97.5|-1.71|-0.85|||ANCOVA|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline PASI score \& multiple imputation to handle missing data|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline PASI score \& multiple imputation to handle missing data|||-0.85|-1.71|<0.0001
73965918|NCT03012841|147468064|SUPERIORITY|The formal alternative hypothesis test for the primary effectiveness objective was that the Kaplan-Meier estimator of treatment success at 12 months (365 days) was greater than 40%, against the null hypothesis that it was less than or equal to 40%.|Kaplan-Meier (product-limit) estimator|54.8|||<|0.001|TWO_SIDED|95.0|46.7|62.1|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||62.1|46.7|<0.001
73965919|NCT03012841|147468065|SUPERIORITY|The formal alternative hypothesis tested for the primary safety objective was that the Kaplan-Meier estimator of the proportion of subjects with primary safety events at 12 months (365 days) was less than 13%, against the null hypothesis that it was greater than or equal to 13%.|Kaplan-Meier (product-limit) estimator|0.6||||0.002|TWO_SIDED|95.0|0.1|4.4|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||4.4|0.1|0.002
73965920|NCT03012841|147468066|SUPERIORITY||Mean Difference (Net)|25.8|||<|0.001|TWO_SIDED|95.0|22.1|29.5||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in AFEQT composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||29.5|22.1|<0.001
74085846|NCT00330460|147725895|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -2.29%.|Mean Difference (Final Values)|1.1|||<|0.0001||95.0|0.7|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1.4|0.7|<0.0001
74085847|NCT00330460|147725896|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.65%|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.6|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1.4|0.6|<0.0001
73915250|NCT01652703|147360036|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-96.3|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-106.0|-86.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-86.5|-106.0|<0.001
73965921|NCT03012841|147468067|SUPERIORITY||Mean Difference (Net)|5.0|||<|0.001|TWO_SIDED|95.0|3.5|6.5||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in SF-12 physical composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||6.5|3.5|<0.001
73965922|NCT03012841|147468068|SUPERIORITY||Mean Difference (Net)|4.9|||<|0.001|TWO_SIDED|95.0|3.2|6.6||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in SF-12 mental composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||6.6|3.2|<0.001
73965923|NCT04491968|147468069|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.02|TWO_SIDED|95.0|0.37|0.9|||proportional hazard regression|||||.90|.37|.02
73965924|NCT04491968|147468070|SUPERIORITY||Hazard Ratio (HR)|0.41||||0.04|TWO_SIDED|95.0|0.18|0.96|||proportional hazard regression|||||.96|.18|.04
73915251|NCT01652703|147360036|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-75.5|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-85.4|-65.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-65.5|-85.4|<0.001
73915252|NCT01652703|147360036|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-88.2|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|-97.4|-79.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-79.0|-97.4|<0.001
73915253|NCT01652703|147360036|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-80.7|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|-90.0|-71.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-71.4|-90.0|<0.001
73915254|NCT01652703|147360037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1945.68|||<|0.001|TWO_SIDED|95.0|89.64|42232.63||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference|||42232.63|89.64|<0.001
73915255|NCT01652703|147360037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|281.13|||<|0.001|TWO_SIDED|95.0|14.74|5360.92||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference|||5360.92|14.74|<0.001
73915256|NCT01652703|147360037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|536.45|||<|0.001|TWO_SIDED|95.0|28.37|10143.4||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference|||10143.40|28.37|<0.001
73915257|NCT01652703|147360037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|595.59|||<|0.001|TWO_SIDED|95.0|31.11|11402.67||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference|||11402.67|31.11|<0.001
73915258|NCT01652703|147360038|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-62.56|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-67.85|-57.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-57.27|-67.85|<0.001
73915259|NCT01652703|147360038|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.46|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|-54.83|-44.08||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-44.08|-54.83|<0.001
73915260|NCT01652703|147360038|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-58.08|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-63.93|-52.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-52.22|-63.93|<0.001
73965925|NCT04878354|147468106|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.0004|TWO_SIDED|95.0|0.58|2.0|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||2.00|0.58|0.0004
73965926|NCT04878354|147468107|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.001|TWO_SIDED|95.0|0.34|1.35|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||1.35|0.34|0.0010
73965927|NCT04878354|147468108|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.0354|TWO_SIDED|95.0|0.03|0.71|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||0.71|0.03|0.0354
73915261|NCT01652703|147360038|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.54|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-59.46|-47.63||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-47.63|-59.46|<0.001
73915262|NCT01652703|147360039|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.69|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-65.67|-55.72||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-55.72|-65.67|<0.001
73915263|NCT01652703|147360039|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.75|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-51.8|-41.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.70|-51.80|<0.001
73915264|NCT01652703|147360039|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.44|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-58.91|-47.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-47.97|-58.91|<0.001
73915265|NCT01652703|147360039|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-47.37|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-52.9|-41.85||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.85|-52.90|<0.001
73915266|NCT01652703|147360040|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-34.49|STANDARD_ERROR_OF_MEAN|11.75||0.004|TWO_SIDED|95.0|-57.71|-11.26||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-11.26|-57.71|0.004
73915267|NCT01652703|147360040|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-24.25|STANDARD_ERROR_OF_MEAN|11.93||0.044|TWO_SIDED|95.0|-47.83|-0.68||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-0.68|-47.83|0.044
73915268|NCT01652703|147360040|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-29.82|STANDARD_ERROR_OF_MEAN|9.36||0.002|TWO_SIDED|95.0|-48.32|-11.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-11.32|-48.32|0.002
73965928|NCT04878354|147468109|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.0734|TWO_SIDED|95.0|-0.02|0.5|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||0.50|-0.02|0.0734
73965929|NCT04878354|147468110|SUPERIORITY||Mean Difference (Final Values)|0.86|||<|0.0001|TWO_SIDED|95.0|0.45|1.28|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||1.28|0.45|<0.0001
73965930|NCT04878354|147468111|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.0002|TWO_SIDED|95.0|0.26|0.82|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.82|0.26|0.0002
73965931|NCT04878354|147468112|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.1516|TWO_SIDED|95.0|-0.11|0.76|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.76|-0.11|0.1516
73965932|NCT04878354|147468113|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9709|TWO_SIDED|95.0|-0.24|0.25|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.25|-0.24|0.9709
73965933|NCT04878354|147468114|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.0499|TWO_SIDED|95.0|0.0|0.41|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.41|0.00|0.0499
74027119|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.17|0.48|
73915269|NCT01652703|147360040|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.82|STANDARD_ERROR_OF_MEAN|9.41||0.028|TWO_SIDED|95.0|-39.41|-2.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-2.22|-39.41|0.028
73915270|NCT01652703|147360041|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.98|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-52.21|-41.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.76|-52.21|<0.001
73965934|NCT04878354|147468115|SUPERIORITY||Median Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.73|2.18|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||2.18|0.73|<0.0001
73965935|NCT04878354|147468116|SUPERIORITY||Median Difference (Final Values)|0.48||||0.0075|TWO_SIDED|95.0|0.13|0.83|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.83|0.13|0.0075
73965936|NCT04878354|147468117|SUPERIORITY||Median Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.44|1.29|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||1.29|0.44|<0.0001
73915271|NCT01652703|147360041|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-37.22|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-42.52|-31.91||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-31.91|-42.52|<0.001
73965937|NCT04878354|147468118|SUPERIORITY||Odds Ratio (OR)|1.2|||<|0.0001|TWO_SIDED|95.0|1.1|1.32|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a severe day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of severe days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||1.32|1.10|<0.0001
73915272|NCT01652703|147360041|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.66|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-52.32|-41.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.00|-52.32|<0.001
73915273|NCT01652703|147360041|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.3|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-51.02|-39.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-39.58|-51.02|<0.001
73915274|NCT01652703|147360042|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-61.35|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-67.14|-55.56||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-55.56|-67.14|<0.001
73915275|NCT01652703|147360042|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-47.53|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-53.41|-41.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.65|-53.41|<0.001
73915276|NCT01652703|147360042|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.75|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-63.73|-51.77||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-51.77|-63.73|<0.001
73965938|NCT04878354|147468119|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9124|TWO_SIDED|95.0|0.93|1.08|||Generalised linear mixed model (GLMM)||Odds ration is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a severe day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of severe days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||1.08|0.93|0.9124
73965939|NCT04878354|147468120|SUPERIORITY||Odds Ratio (OR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.71|0.81|||Generalised linear fixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a well day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of well days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.81|0.71|<0.0001
73965940|NCT04878354|147468121|SUPERIORITY||Odds Ratio (OR)|0.89|||<|0.0001|TWO_SIDED|95.0|0.85|0.93|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a well day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of well days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.93|0.85|<0.0001
73915277|NCT01652703|147360042|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.22|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|-58.27|-46.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-46.18|-58.27|<0.001
73915278|NCT02155608|147360043|SUPERIORITY|||||||0.54||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .38, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.54
73965941|NCT04878354|147468122|SUPERIORITY||Odds Ratio (OR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.72|0.84|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a symptom-free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of symptom-free days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.84|0.72|<0.0001
73965942|NCT04878354|147468123|SUPERIORITY||Odds Ratio (OR)|0.9||||0.0001|TWO_SIDED|95.0|0.86|0.95|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a symptom-free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of symptom-free days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.95|0.86|0.0001
73915279|NCT02155608|147360043|SUPERIORITY||||||<|0.0001||||||p \< .05 for statistical significance|Mixed Models Analysis|Time: F=39.97, df = 1/228||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||<.0001
73915280|NCT02155608|147360043|SUPERIORITY|||||||0.005||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 8.12, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.005
73915281|NCT02155608|147360043|SUPERIORITY||||||<|0.0001||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time2: F = 28.96, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||<.0001
73915282|NCT02155608|147360043|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 6.23, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.02
73915283|NCT02155608|147360043|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 4.18, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
73915284|NCT02155608|147360043|SUPERIORITY|||||||0.73||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .12, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.73
73915285|NCT02155608|147360044|SUPERIORITY|||||||0.003||||||p \< .05 for statistical significance|Chi-squared|Group: F = 8.75, df = 1/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.||||.003
73915286|NCT02155608|147360044|SUPERIORITY|||||||0.17||||||p \< .05 for statistical significance.|Chi-squared|Time: F = 1.69, df = 3/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.||||.17
73965943|NCT04878354|147468126|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.0015|TWO_SIDED|95.0|0.07|0.29|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in an LME model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.29|0.07|0.0015
73965944|NCT04878354|147468127|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.0032|TWO_SIDED|95.0|0.04|0.2|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.20|0.04|0.0032
73965945|NCT04878354|147468128|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9277|TWO_SIDED|95.0|-0.21|0.23|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effects (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.23|-0.21|0.9277
73965946|NCT04878354|147468129|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9643|TWO_SIDED|95.0|-0.19|0.18|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effect (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.18|-0.19|0.9643
73915287|NCT02155608|147360044|SUPERIORITY|||||||0.46|||||||Chi-squared|Group: Chi-square = .53, df = 1.||Phase 1b: Assessed effects of group on categorical measure CGI-I from at Visit 5 compared to baseline.||||.46
73915288|NCT02155608|147360045|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|Group: F=.01; df =1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.91
73915289|NCT02155608|147360045|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|Time: F=13.03; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.0004
73915290|NCT02155608|147360045|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|Group \* time: F = .83; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.37
73915291|NCT02155608|147360045|SUPERIORITY|||||||0.007||||||Time2: F = 7.45, df = 1/209.|Mixed Models Analysis|||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.007
73965947|NCT04878354|147468130|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.0287|TWO_SIDED|95.0|0.02|0.34|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effect (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.34|0.02|0.0287
74085848|NCT00330460|147725897|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.04%|Mean Difference (Final Values)|0.6|||<|0.0001||95.0|0.3|1.0||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1|0.3|<0.0001
73915292|NCT02155608|147360045|SUPERIORITY|||||||0.67||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .19, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.67
73915293|NCT02155608|147360045|SUPERIORITY|||||||0.68||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .17, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.68
73915294|NCT02155608|147360045|SUPERIORITY|||||||0.16||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 2.05, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.16
73915295|NCT02155608|147360046|SUPERIORITY|||||||0.91||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.91
73965948|NCT04878354|147468132|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.58|||Generalized linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet/ odds tree SLIT-tablet)|"Multiple imputation was used to impute missing data under the hypothetical strategy.~The odds of having an improved treatment efficacy according to patient-rated global evaluation was analysed using a generalised linear mixed model with a logit link function. The model includes patient-rated global evaluation of treatment efficacy (improvement/no improvement) as the response variable and treatment, cohort and age group as fixed effects and pollen station as random effects. Observed p-value."||0.58|0.30|<0.0001
73965949|NCT04878354|147468133|SUPERIORITY||Mean Difference (Final Values)|0.43|||<|0.0001|TWO_SIDED|95.0|0.38|0.48|||Mixed Models Analysis||Tree SLIT-tablet vs placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analyzed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.48|0.38|<0.0001
73965950|NCT04878354|147468133|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.1038|TWO_SIDED|95.0|-0.09|0.01|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.01|-0.09|0.1038
73965951|NCT04878354|147468134|SUPERIORITY||Mean Difference (Final Values)|0.53|||<|0.0001|TWO_SIDED|95.0|0.48|0.57|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.57|0.48|<0.0001
73965952|NCT04878354|147468134|SUPERIORITY||Mean Difference (Final Values)|0.49|||<|0.0001|TWO_SIDED|95.0|0.45|0.53|||Mixed Models Analysis||Tree SLIT-tablet vs placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.53|0.45|<0.0001
74027120|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.58|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.05|0.58|
73915296|NCT02155608|147360046|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.12, df = .15||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.15
73915297|NCT02155608|147360046|SUPERIORITY|||||||0.64||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .21, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.64
73915298|NCT02155608|147360046|SUPERIORITY|||||||0.66||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .20, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.66
73915299|NCT02155608|147360046|SUPERIORITY|||||||0.48||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .50, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.48
73915300|NCT02155608|147360046|SUPERIORITY|||||||0.81||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .06, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.81
73965953|NCT04878354|147468135|SUPERIORITY||Mean Difference (Final Values)|0.29|||<|0.0001|TWO_SIDED|95.0|0.24|0.33|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analyzed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.33|0.24|<0.0001
73965954|NCT04878354|147468135|SUPERIORITY||Mean Difference (Final Values)|0.31|||<|0.0001|TWO_SIDED|95.0|0.26|0.36|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.36|0.26|<0.0001
73965955|NCT02380612|147468144|OTHER||Geometric Mean Ratio|1.4575|||||TWO_SIDED|||||||||||||
74085849|NCT00330460|147725898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.0001||95.0|0.3|0.9||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||0.9|0.3|0.0001
73915301|NCT02155608|147360047|SUPERIORITY|||||||0.89||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .02, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.89
73915302|NCT02155608|147360047|SUPERIORITY|||||||0.14||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.28, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.14
73915303|NCT02155608|147360047|SUPERIORITY|||||||0.8||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .06, df = .81.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.80
73915304|NCT02155608|147360047|SUPERIORITY|||||||0.93||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.93
73915305|NCT02155608|147360047|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.22, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.15
73915306|NCT02155608|147360047|SUPERIORITY|||||||0.28||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.23, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.28
73915307|NCT02155608|147360048|SUPERIORITY|||||||0.91||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01; df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.91
73915308|NCT02155608|147360048|SUPERIORITY|||||||0.11||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.62, df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.11
73915309|NCT02155608|147360048|SUPERIORITY|||||||0.4||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .71; df = .40.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.40
73915310|NCT02155608|147360048|SUPERIORITY|||||||0.49||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .48. df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.49
73915311|NCT02155608|147360048|SUPERIORITY|||||||0.18||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.87, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.18
73915312|NCT02155608|147360048|SUPERIORITY|||||||0.72||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .13, df = 1/38.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.72
73915313|NCT02155608|147360049|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|Group: F =.25, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.62
73915314|NCT02155608|147360049|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|Time: F = 3.58, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.06
73915315|NCT02155608|147360049|SUPERIORITY|||||||0.09||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 2.90, df 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.09
73915316|NCT02155608|147360049|SUPERIORITY|||||||0.06||||||p \< .05 for statistical significance|Mixed Models Analysis|Group: F = 3.36, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.06
73915317|NCT02155608|147360049|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.20, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
73915318|NCT02155608|147360049|SUPERIORITY|||||||0.42||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .66, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.42
73915319|NCT02155608|147360050|SUPERIORITY|||||||0.29||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 0.29, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.29
73915320|NCT02155608|147360050|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.83, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.02
74027121|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|0.6|||||TWO_SIDED|95.0|0.41|0.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.88|0.41|
74085850|NCT02412722|147725900|SUPERIORITY||Geometric Mean Ratio|0.59|||||TWO_SIDED|90.0|0.46|0.76||||||||0.76|0.46|
73915321|NCT02155608|147360050|SUPERIORITY|||||||0.31||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.03, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.31
73915322|NCT02155608|147360050|SUPERIORITY|||||||0.69||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.69
74085851|NCT02412722|147725901|SUPERIORITY||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.59|1.36||||||||1.36|0.59|
74085852|NCT02412722|147725902|SUPERIORITY||Geometric Mean Ratio|1.04|||||TWO_SIDED|90.0|0.72|1.49||||||||1.49|0.72|
73915323|NCT02155608|147360050|SUPERIORITY|||||||0.33||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .98, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.33
73915324|NCT02155608|147360050|SUPERIORITY|||||||0.35||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .88, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.35
73915325|NCT02155608|147360051|SUPERIORITY|||||||0.21||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 1.62, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.21
73915326|NCT02155608|147360051|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.18, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.02
73915327|NCT02155608|147360051|SUPERIORITY|||||||0.01||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 6.89, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.01
73915328|NCT02155608|147360051|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F= 2.16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.15
73915329|NCT02155608|147360051|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.15, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
73915330|NCT02155608|147360051|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.79
73915331|NCT02155608|147360052|SUPERIORITY|||||||0.94||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.94
73915332|NCT02155608|147360052|SUPERIORITY|||||||0.76||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .09, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.76
73915333|NCT02155608|147360052|SUPERIORITY|||||||0.39||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .75, df =1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.39
73915334|NCT02155608|147360052|SUPERIORITY|||||||0.09||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.06, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.09
73915335|NCT02155608|147360052|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.79
73915336|NCT02155608|147360052|SUPERIORITY|||||||0.22||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.55, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.22
73915337|NCT02155608|147360053|SUPERIORITY|||||||0.64||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .22, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.64
74027122|NCT01025336|147607530|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.05|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.81|1.05|
74027123|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.27|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.40|1.27|
74085853|NCT02412722|147725906|SUPERIORITY||Geometric Mean Ratio|1.07|||||TWO_SIDED|90.0|0.78|1.47||||||||1.47|0.78|
74085854|NCT02412722|147725907|SUPERIORITY||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|0.75|1.68||||||||1.68|0.75|
73915338|NCT02155608|147360053|SUPERIORITY|||||||0.19||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.19
73915339|NCT02155608|147360053|SUPERIORITY|||||||0.22||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.22
74085855|NCT02412722|147725908|SUPERIORITY||Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.67|1.26||||||||1.26|0.67|
74085856|NCT05766787|147725931|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||-0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, period, sequence, visit, and lens by visit interaction) and random (subject) effects. Difference = LID022821 minus AOHG. Sign is retained with the rounded value.|||-0.01||
73915340|NCT02155608|147360053|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.95, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
73915341|NCT02155608|147360053|SUPERIORITY|||||||0.96||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 0.00, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.96
73915342|NCT02155608|147360053|SUPERIORITY|||||||0.92||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .01, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.92
73915343|NCT02155608|147360054|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .07, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.79
73915344|NCT02155608|147360054|SUPERIORITY|||||||0.3||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.10, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.30
73965956|NCT04869982|147468189|OTHER|VE was defined as 1 minus the relative risk (RR). RR was defined as the ratio of the incidence rates of the RZV Group over the Placebo Group. The VE of RZV against HZ was to be demonstrated if the lower limit (LL) of the two-sided 95% CI of VE was above 25%.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|89.82|100.0||All p-values reported were related to the null hypothesis test VE = 0.|Poisson|The CI for VE is derived from the exact CI from RR.||To demonstrate the vaccine efficacy (VE) of RZV against HZ, the analysis considered the exact inference on the relative risk adjusted for age strata conditionally to the total number of confirmed HZ cases observed and time at risk. This method computed an exact confidence interval (CI) around the rate ratio (ratio of the event rates in the RZV Group versus Placebo Group) and accounted for the sum of the time at risk of the participants within each group.||100|89.82|<0.0001
73965957|NCT01631214|147468204|SUPERIORITY|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|0.36|0.64|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.64|0.36|<0.001
73965958|NCT01631214|147468204|SUPERIORITY||Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.38|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.66|0.38|
74027124|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.95|1.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.59|0.95|
74027125|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.03|2.29|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.29|1.03|
73915345|NCT02155608|147360054|SUPERIORITY|||||||0.03||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 4.61, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.03
74027126|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.95|1.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.97|0.95|
74027127|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|2.2|||||TWO_SIDED|95.0|1.42|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||3.31|1.42|
73915346|NCT02155608|147360054|SUPERIORITY|||||||0.14||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 2.24, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.14
73915347|NCT02155608|147360054|SUPERIORITY|||||||0.82||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .05, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.82
73915348|NCT02155608|147360054|SUPERIORITY|||||||0.07||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 3.35, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.07
73915349|NCT02155608|147360055|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|Group: F = .36, df = 1/52||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.55
73915350|NCT02155608|147360055|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Time: F = .09, df = 1/52||Phase 1a: Outcomes were fitted via a mixed model with group, time, and group-by-time interactions to test for treatment effects.||||.34
73965959|NCT01631214|147468204|SUPERIORITY||Absolute risk reduction|4.03|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|2.5|5.57||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||5.57|2.50|
74085857|NCT01435928|147725932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.039|TWO_SIDED|95.0|0.45|0.98|||Log Rank|||||0.98|0.45|0.039
73859754|NCT02446418|147265662|SUPERIORITY||Adjusted Odds Ratio|1.41||||0.566|TWO_SIDED|95.0|0.43|4.6|||Regression, Logistic|||Week 24|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.|4.60|0.43|0.566
73859755|NCT02014480|147265665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.065|0.151||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 milliliters (mL) at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.151|0.065|<0.001
73859756|NCT02014480|147265665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|||<|0.001|TWO_SIDED|95.0|0.064|0.149||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.149|0.064|<0.001
73859757|NCT02014480|147265665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|||<|0.001|TWO_SIDED|95.0|0.086|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.171|0.086|<0.001
73859758|NCT02014480|147265665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|||<|0.001|TWO_SIDED|95.0|0.04|0.125||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.125|0.040|<0.001
73859759|NCT02014480|147265665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|||<|0.001|TWO_SIDED|95.0|0.036|0.12||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.120|0.036|<0.001
73859760|NCT02014480|147265665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057||||0.008|TWO_SIDED|95.0|0.015|0.099||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.099|0.015|0.008
73859761|NCT01854632|147265669|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Log Rank|||||||0.996
73859762|NCT01414205|147265680|SUPERIORITY_OR_OTHER||Difference (Hauck-Anderson)|17.89||||0.0779|TWO_SIDED|95.0|-4.95|40.72|||Cochran-Mantel-Haenszel|P-values based on stratified Cochran-Mantel-Haenszel test by the randomization stratification factors as supportive analyses.||||40.72|-4.95|0.0779
73859763|NCT02305849|147265705|SUPERIORITY||Percent Difference|36.9|||<|0.001|TWO_SIDED|95.0|26.7|47.0||Closed testing procedure was used for multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution.|Treatment Difference vs Placebo||47.0|26.7|<0.001
73859764|NCT02305849|147265705|SUPERIORITY||Percent difference|42.6|||<|0.001|TWO_SIDED|95.0|32.6|52.6||Closed testing procedure was used for multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution.|Treatment Difference vs Placebo||52.6|32.6|<0.001
73859765|NCT02305849|147265706|SUPERIORITY||||||<|0.001||||||Closed testing procedure was used for multiplicity adjustment.|RANCOVA|Based on Rank Analysis of Covariance (RANCOVA) Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.||Treatment Difference vs Placebo||||<0.001
73859766|NCT02305849|147265706|SUPERIORITY||||||<|0.001||||||Closed testing procedure was used for multiplicity adjustment.|RANCOVA|Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.||Treatment Difference vs Placebo||||<0.001
73859767|NCT02305849|147265708|SUPERIORITY||Percent Difference|22.2|||<|0.001|TWO_SIDED|95.0|13.8|30.7||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||30.7|13.8|<0.001
73859768|NCT02305849|147265708|SUPERIORITY||Percent Difference|38.3|||<|0.001|TWO_SIDED|95.0|29.3|47.3||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||47.3|29.3|<0.001
73859769|NCT02305849|147265710|SUPERIORITY||Percent Difference|9.7|||<|0.001|TWO_SIDED|95.0|3.8|15.6||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||15.6|3.8|<0.001
73859770|NCT02305849|147265710|SUPERIORITY||Percent Difference|21.2|||<|0.001|TWO_SIDED|95.0|13.9|28.5||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||28.5|13.9|<0.001
73859771|NCT02305849|147265712|SUPERIORITY||||||<|0.001||||||Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.|RANCOVA|||Treatment Difference vs Placebo||||<0.001
73859772|NCT02305849|147265712|SUPERIORITY||||||<|0.001||||||Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.|RANCOVA|||Treatment Difference vs Placebo||||<0.001
73859773|NCT02305849|147265713|SUPERIORITY|||||||0.018|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.||Week 28/ET: Treatment Difference vs Placebo||||0.018
73859774|NCT02305849|147265713|SUPERIORITY|||||||0.002|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.||Week 28/ET: Treatment Difference vs Placebo||||0.002
73859775|NCT02305849|147265713|SUPERIORITY|||||||0.039|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.||Week 52/ET: Treatment Difference vs Placebo||||0.039
73915351|NCT02155608|147360055|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|Group \* time: F = .06, df = 1/52||Phase 1 a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interaction to test for treatment effects.||||.81
73915352|NCT02155608|147360055|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Group: F = .05, df = 1/59||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.83
73915353|NCT02155608|147360055|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|Time: F = 4.52, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.04
73915354|NCT02155608|147360055|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|Group \* time: F = .12, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.73
73915355|NCT02155608|147360056|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.62, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.21
73915356|NCT02155608|147360056|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|Time: F = .74, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.39
73915357|NCT02155608|147360056|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|Time2: F = 1.88, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.18
73915358|NCT02155608|147360056|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|Group \* time: F = 1.56; df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.22
73915359|NCT02155608|147360056|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.72, df = 1/12.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.21
73915360|NCT02155608|147360056|SUPERIORITY|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Time: F = 0.00, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||1
73965960|NCT01631214|147468205|SUPERIORITY|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Hazard Ratio (HR)|0.73|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.61|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)|||0.88|0.61|<0.001
74027128|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.88|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.04|0.88|
73915361|NCT02155608|147360056|SUPERIORITY|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Group \* time: F = .87, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||1
73915362|NCT03808493|147360081|EQUIVALENCE|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the least square means (LS-Means) between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0211|||||TWO_SIDED|90.0|-0.0752|0.0329||||||||0.0329|-0.0752|
73915363|NCT03808493|147360081|EQUIVALENCE|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0019|||||TWO_SIDED|90.0|-0.0778|0.0815||||||||0.0815|-0.0778|
73915364|NCT03808493|147360082|EQUIVALENCE|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0698|||||TWO_SIDED|90.0|-0.1404|0.0008||||||||0.0008|-0.1404|
73915365|NCT03808493|147360082|EQUIVALENCE|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0811|||||TWO_SIDED|90.0|-0.1658|0.0036||||||||0.0036|-0.1658|
73915366|NCT03808493|147360083|EQUIVALENCE|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0199|||||TWO_SIDED|90.0|-0.0731|0.0333||||||||0.0333|-0.0731|
73915367|NCT03808493|147360083|EQUIVALENCE|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0035|||||TWO_SIDED|90.0|-0.076|0.083||||||||0.0830|-0.0760|
74085858|NCT01435928|147725933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.07|TWO_SIDED|95.0|0.54|1.03|||Log Rank|||||1.03|0.54|0.070
74085859|NCT01435928|147725934|SUPERIORITY_OR_OTHER|||||||0.029|||||||ANCOVA|LOCF||||||0.029
74085860|NCT01435928|147725935|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|LOCF||||||0.015
73859776|NCT02305849|147265713|SUPERIORITY|||||||0.006|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.||Week 52/ET: Treatment Difference vs Placebo||||0.006
73859777|NCT02305849|147265714|SUPERIORITY|||||||0.036|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 28/ET: Treatment Difference vs Placebo||||0.036
73859778|NCT02305849|147265714|SUPERIORITY||||||<|0.001|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 28/ET: Treatment Difference vs Placebo||||<0.001
73859779|NCT02305849|147265714|SUPERIORITY|||||||0.013|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 52/ET: Treatment Difference vs Placebo||||0.013
73859780|NCT02305849|147265714|SUPERIORITY||||||<|0.001|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 52/ET: Treatment Difference vs Placebo||||<0.001
73859781|NCT02305849|147265715|SUPERIORITY||Percent Difference|21.3|||<|0.001|TWO_SIDED|95.0|10.0|32.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 28/ET: Treatment Difference vs Placebo||32.6|10.0|<0.001
73859782|NCT02305849|147265715|SUPERIORITY||Percent Difference|26.8|||<|0.001|TWO_SIDED|95.0|15.7|37.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 28/ET: Treatment Difference vs Placebo||37.9|15.7|<0.001
73859783|NCT02305849|147265715|SUPERIORITY||Percent Difference|21.5|||<|0.001|TWO_SIDED|95.0|10.2|32.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 52/ET: Treatment Difference vs Placebo||32.9|10.2|<0.001
73859784|NCT02305849|147265715|SUPERIORITY||Percent Difference|26.4|||<|0.001|TWO_SIDED|95.0|15.2|37.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 52/ET: Treatment Difference vs Placebo||37.6|15.2|<0.001
73859785|NCT02305849|147265716|SUPERIORITY||LS Mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.46|-0.97||No multiplicity adjustment.|ANCOVA|Based on ANCOVA (analysis of covariance) Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-0.97|-1.46|<0.001
73915368|NCT03808493|147360084|EQUIVALENCE|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.1902|||||TWO_SIDED|90.0|0.0199|0.3605||||||||0.3605|0.0199|
73915369|NCT03808493|147360084|EQUIVALENCE|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.2142|||||TWO_SIDED|90.0|0.0558|0.3725||||||||0.3725|0.0558|
73915370|NCT03808493|147360085|EQUIVALENCE|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0311|||||TWO_SIDED|90.0|0.0022|0.0599||||||||0.0599|0.0022|
74085861|NCT01435928|147725936|SUPERIORITY_OR_OTHER|||||||0.218|||||||ANCOVA|LOCF||||||0.218
74085862|NCT01435928|147725937|SUPERIORITY_OR_OTHER|||||||0.021|||||||ANCOVA|LOCF||||||0.021
73859786|NCT02305849|147265716|SUPERIORITY||LS Mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.85|-1.33||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-1.33|-1.85|<0.001
73859787|NCT02305849|147265718|SUPERIORITY||LS Mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.44|-0.94||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-0.94|-1.44|<0.001
73859788|NCT02305849|147265718|SUPERIORITY||LS Mean difference|-1.63|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.89|-1.36||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-1.36|-1.89|<0.001
73859789|NCT02305849|147265720|SUPERIORITY||LS Mean difference|-5.2|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-6.9|-3.5||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.||Treatment Difference vs Placebo||-3.5|-6.9|<0.001
73859790|NCT02305849|147265720|SUPERIORITY||LS Mean difference|-7.2|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-8.9|-5.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.||Treatment Difference vs Placebo||-5.6|-8.9|<0.001
73859791|NCT02305849|147265722|SUPERIORITY||LS Mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.3|-2.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.||Treatment Difference vs Placebo||-2.6|-5.3|<0.001
73859792|NCT02305849|147265722|SUPERIORITY||LS Mean difference|-5.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-6.9|-4.3||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.||Treatment Difference vs Placebo||-4.3|-6.9|<0.001
73859793|NCT02305849|147265724|SUPERIORITY||Percent Difference|23.7|||<|0.001|TWO_SIDED|95.0|15.1|32.3||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||32.3|15.1|<0.001
73859794|NCT02305849|147265724|SUPERIORITY||Percent Difference|27.4|||<|0.001|TWO_SIDED|95.0|18.6|36.2||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||36.2|18.6|<0.001
73859795|NCT02305849|147265726|SUPERIORITY||Percent Difference|10.4|||<|0.001|TWO_SIDED|95.0|4.3|16.5||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected)|Treatment Difference vs Placebo||16.5|4.3|<0.001
73859796|NCT02305849|147265726|SUPERIORITY||Percent Difference|16.9|||<|0.001|TWO_SIDED|95.0|10.0|23.9||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected)|Treatment Difference vs Placebo||23.9|10.0|<0.001
73859797|NCT02305849|147265728|SUPERIORITY||Percent Difference|34.7|||<|0.001|TWO_SIDED|95.0|25.1|44.2||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||44.2|25.1|<0.001
74085863|NCT01435928|147725938|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANCOVA|LOCF||||||0.056
73859798|NCT02305849|147265728|SUPERIORITY||Percent Difference|45.5|||<|0.001|TWO_SIDED|95.0|36.0|55.0||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||55.0|36.0|<0.001
73859799|NCT02305849|147265730|SUPERIORITY||Percent Difference|20.3|||<|0.001|TWO_SIDED|95.0|12.5|28.1||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||28.1|12.5|<0.001
73859800|NCT02305849|147265730|SUPERIORITY||Percent Difference|31.5|||<|0.001|TWO_SIDED|95.0|23.1|40.0||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||40.0|23.1|<0.001
73859801|NCT02305849|147265732|SUPERIORITY||LS Mean Difference|-1.597|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.948|-1.247||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: CRP Change = Treatment + Baseline CRP.||Treatment Difference vs Placebo||-1.247|-1.948|<0.001
73859802|NCT02305849|147265732|SUPERIORITY||LS Mean Difference|-1.458|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.852|-1.065||No multiplicity adjustment.|ANCOVA|||Treatment Difference vs Placebo||-1.065|-1.852|<0.001
73859803|NCT02305849|147265734|SUPERIORITY||LS Mean Difference|-17.89|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-21.61|-14.17||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.||Treatment Difference vs Placebo||-14.17|-21.61|<0.001
73859804|NCT02305849|147265734|SUPERIORITY||LS Mean Difference|-20.61|STANDARD_ERROR_OF_MEAN|2.06|<|0.001|TWO_SIDED|95.0|-24.67|-16.56||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.||Treatment Difference vs Placebo||-16.56|-24.67|<0.001
73859805|NCT02305849|147265736|SUPERIORITY||Percent Difference|33.0|||<|0.001|TWO_SIDED|95.0|23.7|42.2||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||42.2|23.7|<0.001
73859806|NCT02305849|147265736|SUPERIORITY||Percent Difference|45.5|||<|0.001|TWO_SIDED|95.0|36.2|54.8||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||54.8|36.2|<0.001
73859807|NCT02305849|147265738|SUPERIORITY||Percent Difference|42.4|||<|0.001|TWO_SIDED|95.0|32.3|52.5||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected|Treatment Difference vs Placebo||52.5|32.3|<0.001
73859808|NCT02305849|147265738|SUPERIORITY||Percent Difference|49.3|||<|0.001|TWO_SIDED|95.0|39.7|58.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected|Treatment Difference vs Placebo||58.9|39.7|<0.001
73915371|NCT03808493|147360085|EQUIVALENCE|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0306|||||TWO_SIDED|90.0|-0.0003|0.0616||||||||0.0616|-0.0003|
73915372|NCT03808493|147360086|EQUIVALENCE|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0209|||||TWO_SIDED|90.0|-0.0112|0.053||||||||0.0530|-0.0112|
73915373|NCT03808493|147360086|EQUIVALENCE|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0135|||||TWO_SIDED|90.0|-0.0508|0.0238||||||||0.0238|-0.0508|
73915374|NCT01806545|147360125|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.11||||0.1197|TWO_SIDED|95.0|-0.242|0.025||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel|||||0.025|-0.242|0.1197
73859809|NCT02305849|147265740|SUPERIORITY||Percent Difference|19.7|||<|0.001|TWO_SIDED|95.0|12.1|27.3|||Fisher Exact|No multiplicity adjustment.|CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||27.3|12.1|<0.001
73859810|NCT02305849|147265740|SUPERIORITY||Percent Difference|30.4|||<|0.001|TWO_SIDED|95.0|22.0|38.7||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||38.7|22.0|<0.001
73859811|NCT02305849|147265742|SUPERIORITY||Percent Difference|42.5|||<|0.001|TWO_SIDED|95.0|32.3|52.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||52.6|32.3|<0.001
73859812|NCT02305849|147265742|SUPERIORITY||Percent Difference|47.0|||<|0.001|TWO_SIDED|95.0|37.1|56.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||56.9|37.1|<0.001
73859813|NCT02305849|147265744|SUPERIORITY||Percent Difference|5.2||||0.011|TWO_SIDED|95.0|1.0|9.5||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||9.5|1.0|0.011
73859814|NCT02305849|147265744|SUPERIORITY||Percent Difference|9.3|||<|0.001|TWO_SIDED|95.0|4.1|14.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||14.6|4.1|<0.001
73859815|NCT02305849|147265746|SUPERIORITY|No multiplicity adjustment.|Percent Difference|6.4||||0.003|TWO_SIDED|95.0|1.8|11.0|||Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||11.0|1.8|0.003
73859816|NCT02305849|147265746|SUPERIORITY||Percent Difference|13.4|||<|0.001|TWO_SIDED|95.0|7.5|19.4||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||19.4|7.5|<0.001
73859817|NCT02305849|147265748|SUPERIORITY||LS Mean Difference|-11.22|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|-13.84|-8.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.||Treatment Difference vs Placebo||-8.60|-13.84|<0.001
73859818|NCT02305849|147265748|SUPERIORITY||LS Mean Difference|-14.67|STANDARD_ERROR_OF_MEAN|1.36|<|0.001|TWO_SIDED|95.0|-17.35|-11.98||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.||Treatment Difference vs Placebo||-11.98|-17.35|<0.001
73915375|NCT01806545|147360126|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.08||||0.1962|TWO_SIDED|95.0|-0.204|0.045||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel|||||0.045|-0.204|0.1962
73915376|NCT01806545|147360127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||||||0.090
73915377|NCT01806545|147360128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|TWO_SIDED||||||Log Rank|P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.||Analysis of time to loss of patency||||0.193
73915378|NCT01806545|147360129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.231
73915379|NCT01806545|147360130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.158
73915380|NCT01806545|147360131|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.895|||||TWO_SIDED|95.0|-2.213|0.423||||||Treatment difference at week 12||0.423|-2.213|
73915381|NCT01806545|147360131|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.232|||||TWO_SIDED|95.0|-1.791|1.327||||||Treatment difference at week 26||1.327|-1.791|
73915382|NCT01806545|147360132|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.04|||||TWO_SIDED|95.0|-0.273|0.2||||||Analysis of week 12||0.200|-0.273|
73915383|NCT01806545|147360132|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|0.08|||||TWO_SIDED|95.0|-0.165|0.318||||||Analysis of week 26||0.318|-0.165|
73915384|NCT01806545|147360133|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.154|||||TWO_SIDED|95.0|-0.096|0.404||||||Analysis of week 12||0.404|-0.096|
73915385|NCT01806545|147360133|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.565|||||TWO_SIDED|95.0|-0.023|1.152||||||Analysis of week 26||1.152|-0.023|
73915386|NCT02064894|147360136|SUPERIORITY_OR_OTHER|||||||0.81|||||||Cochran-Mantel-Haenszel|||||||0.81
73915387|NCT00133952|147360169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.724|TWO_SIDED|95.0|0.15|2.67|||Fisher Exact|||||2.67|0.15|0.724
73915388|NCT00133952|147360170|SUPERIORITY_OR_OTHER||LS Mean difference|-3.3||||0.616|TWO_SIDED|95.0|-16.5|9.8|||Mixed models repeated measures|||||9.8|-16.5|0.616
73915389|NCT00133952|147360171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.971|TWO_SIDED|95.0|0.68|1.44|||Cochran-Mantel-Haenszel|||||1.44|0.68|0.971
73915390|NCT00133952|147360173|SUPERIORITY_OR_OTHER||LS Mean difference|0.5||||0.344|TWO_SIDED|95.0|-0.6|1.6|||Mixed models repeated measures|||||1.6|-0.6|0.344
73915391|NCT00133952|147360174|SUPERIORITY_OR_OTHER|||||||0.663||95.0|||||ANCOVA|||||||0.663
73915392|NCT00133952|147360175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.203|TWO_SIDED|95.0|0.37|1.23|||Cochran-Mantel-Haenszel|||||1.23|0.37|0.203
73915393|NCT00133952|147360177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.749|TWO_SIDED|95.0|0.46|2.92|||Cochran-Mantel-Haenszel|||||2.92|0.46|0.749
73915394|NCT00299104|147360178|SUPERIORITY_OR_OTHER|||||||0.0016||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Kruskal-Wallis|||Comparing all three treatment groups||||0.0016
73915395|NCT00299104|147360178|SUPERIORITY_OR_OTHER|||||||0.1824||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status||||0.1824
73915396|NCT00299104|147360178|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.0004
73915397|NCT00299104|147360179|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups||||0.0004
73915398|NCT00299104|147360179|SUPERIORITY_OR_OTHER|||||||0.1194||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.1194
73915399|NCT00299104|147360179|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.0001
73915400|NCT00299104|147360180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.3803||95.0|-0.05|0.13||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||0.13|-0.05|0.3803
73915401|NCT00299104|147360180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.0309||95.0|0.01|0.18||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||0.18|0.01|0.0309
73915402|NCT00299104|147360181|SUPERIORITY_OR_OTHER|||||||0.3752||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||0.3752
73915403|NCT00299104|147360181|SUPERIORITY_OR_OTHER|||||||0.0081||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (1.0 g x 2) + Methotrexate verus Placebo + Methotrexate, stratified for region and Baseline RF status.||||0.0081
73915404|NCT00299104|147360182|SUPERIORITY_OR_OTHER|||||||0.5939||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups.||||0.5939
73915405|NCT00299104|147360182|SUPERIORITY_OR_OTHER|||||||0.5478||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.5478
73859819|NCT02305849|147265750|SUPERIORITY||LS Mean difference|-17.67|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-22.11|-13.22||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).||Treatment Difference vs Placebo||-13.22|-22.11|<0.001
74085864|NCT00442546|147725957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.37||0.9185||95.0|-0.766|0.691||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p\<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the analysis of variance (ANOVA) model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference|||0.691|-0.766|0.9185
73859820|NCT02305849|147265750|SUPERIORITY||LS Mean Difference|-24.09|STANDARD_ERROR_OF_MEAN|2.33|<|0.001||95.0|-28.66|-19.51||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).||Treatment Difference vs Placebo||-19.51|-28.66|<0.001
73859821|NCT02305849|147265752|SUPERIORITY||LS Mean Difference|-16.64|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-21.09|-12.19||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS)||Treatment Difference vs Placebo||-12.19|-21.09|<0.001
73859822|NCT02305849|147265752|SUPERIORITY||LS Mean difference|-20.34|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-25.07|-15.61||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS).||Treatment Difference vs Placebo||-15.61|-25.07|<0.001
73915406|NCT00299104|147360182|SUPERIORITY_OR_OTHER|||||||0.3096||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.3096
73915407|NCT00299104|147360187|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||<0.0001
73915408|NCT00299104|147360187|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||<0.0001
73915409|NCT00299104|147360197|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate stratified for region and RF status.||||<0.0001
73915410|NCT00299104|147360197|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
73965961|NCT01631214|147468206|SUPERIORITY|If the 2 primary endpoints and the specified BMD secondary endpoints were all significant, the nonvertebral fracture at the primary analysis was evaluated based on a 1-sided test (overall α=0.025) determined by the Lan-DeMets alpha spending function that approximates a Pocock boundary, 0.0233 (1-sided).|Hazard Ratio (HR)|0.81|STANDARD_ERROR_OF_MEAN|0.1||0.04|TWO_SIDED|95.0|0.66|0.99||The adjusted 2-sided p-value is reported.|Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.99|0.66|0.040
73965962|NCT01631214|147468207|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.65|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.56|0.76|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.76|0.56|<0.001
74088401|NCT00107042|147730238|SUPERIORITY_OR_OTHER|||||||0.0608|||||||Wilcoxon (Mann-Whitney)|||Analysis included an assessment of quantitative titer values in each of the two arms using confidence intervals and examining the frequency distributions of the titers in each arm. Transformations were considered (log10) for the titers based on the distributional properties observed in the sample, with the goal of attaining approximate normality of the transformed data.||||0.0608
73859823|NCT02305849|147265754|SUPERIORITY||LS Mean Difference|-17.19|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-22.0|-12.38||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).||Treatment Difference vs Placebo||-12.38|-22.00|<0.001
73859824|NCT02305849|147265754|SUPERIORITY||LS Mean difference|-20.89|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-25.8|-15.98||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).||Treatment Difference vs Placebo||-15.98|-25.80|<0.001
73859825|NCT02305849|147265757|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.36|-0.17||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.||Treatment Difference vs Placebo||-0.17|-0.36|<0.001
73859826|NCT02305849|147265757|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.48|-0.29||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.||Treatment Difference vs Placebo||-0.29|-0.48|<0.001
73859827|NCT02305849|147265759|SUPERIORITY||LS Mean Difference|6.41|STANDARD_ERROR_OF_MEAN|1.18|<|0.001|TWO_SIDED|95.0|4.09|8.74||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||8.74|4.09|<0.001
73859828|NCT02305849|147265759|SUPERIORITY||LS Mean Difference|8.61|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|6.36|10.86||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||10.86|6.36|<0.001
73915411|NCT00299104|147360203|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Week 104: Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status.||||<0.0001
73859829|NCT02305849|147265761|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|1.21|4.18||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||4.18|1.21|<0.001
73859830|NCT02305849|147265761|SUPERIORITY||LS Mean Difference|1.65|STANDARD_ERROR_OF_MEAN|0.78||0.036|TWO_SIDED|95.0|0.11|3.19||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||3.19|0.11|0.036
73859831|NCT02305849|147265763|SUPERIORITY||LS Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|1.39||0.099|TWO_SIDED|95.0|-0.44|5.02||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||5.02|-0.44|0.099
73859832|NCT02305849|147265763|SUPERIORITY||LS Mean Difference|4.22|STANDARD_ERROR_OF_MEAN|1.37||0.002|TWO_SIDED|95.0|1.53|6.91||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||6.91|1.53|0.002
73859833|NCT02305849|147265765|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|2.43||0.879|TWO_SIDED|95.0|-5.16|4.42||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||4.42|-5.16|0.879
73859834|NCT02305849|147265765|SUPERIORITY||LS Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|2.05||0.377|TWO_SIDED|95.0|-5.86|2.23||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||2.23|-5.86|0.377
73859835|NCT02305849|147265767|SUPERIORITY||LS Mean Difference|-9.63|STANDARD_ERROR_OF_MEAN|3.5||0.007|TWO_SIDED|95.0|-16.54|-2.73||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-2.73|-16.54|0.007
73859836|NCT02305849|147265767|SUPERIORITY||LS Mean Difference|-14.17|STANDARD_ERROR_OF_MEAN|3.58|<|0.001|TWO_SIDED|95.0|-21.24|-7.1||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-7.10|-21.24|<0.001
73859837|NCT02305849|147265769|SUPERIORITY||LS Mean Difference|-9.43|STANDARD_ERROR_OF_MEAN|3.63||0.01|TWO_SIDED|95.0|-16.6|-2.25||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-2.25|-16.60|0.010
73859838|NCT02305849|147265769|SUPERIORITY||LS Mean Difference|-14.61|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-21.92|-7.31||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-7.31|-21.92|<0.001
73859839|NCT02305849|147265771|SUPERIORITY||LS Mean Difference|-13.19|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-18.23|-8.16||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-8.16|-18.23|<0.001
73859840|NCT02305849|147265771|SUPERIORITY||LS Mean Difference|-17.61|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-22.57|-12.66||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-12.66|-22.57|<0.001
73859841|NCT00997425|147265777|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED|||||values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door approach behavior||||||0.098
73859842|NCT00997425|147265777|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door pass through behavior||||||0.045
73859843|NCT01300819|147265791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.147|TWO_SIDED|95.0|-8.43|1.26||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysing was performed with ANCOVA model, adjusted for several terms.||Null hypothesis: mean change in the total Nonmotor Symptoms Scale (NMSS) score is the same for rotigotine- and placebo-treated group.||1.26|-8.43|0.147
73859844|NCT01300819|147265792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.002|TWO_SIDED|95.0|-4.27|-0.92||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.92|-4.27|0.002
73859845|NCT01300819|147265793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.79||||0.024|TWO_SIDED|95.0|-5.21|-0.37||Two-sided p-values are presented.|ANCOVA|Testing was performed using an ANCOVA model, adjusted for several terms.||||-0.37|-5.21|0.024
73859846|NCT01300819|147265794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.773|TWO_SIDED|95.0|-0.67|0.5||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.50|-0.67|0.773
73859847|NCT01300819|147265795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.122|TWO_SIDED|95.0|-2.41|0.29||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.29|-2.41|0.122
73859848|NCT01300819|147265796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81||||0.047|TWO_SIDED|95.0|-3.59|-0.02||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.02|-3.59|0.047
73859849|NCT01300819|147265797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.601|TWO_SIDED|95.0|-0.22|0.37||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.37|-0.22|0.601
73859850|NCT01300819|147265798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.997|TWO_SIDED|95.0|-0.99|0.99||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.99|-0.99|0.997
73859851|NCT01300819|147265799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.584|TWO_SIDED|95.0|-0.87|0.49||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.49|-0.87|0.584
73859852|NCT01300819|147265800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.536|TWO_SIDED|95.0|-0.84|1.6||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||1.60|-0.84|0.536
73859853|NCT01300819|147265801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.889|TWO_SIDED|95.0|-0.81|0.94||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.94|-0.81|0.889
74085865|NCT00442546|147725957|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.339|STANDARD_ERROR_OF_MEAN|0.371||0.3619||95.0|-1.07|0.392||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p\<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the ANOVA model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference|||0.392|-1.070|0.3619
73859854|NCT01300819|147265802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.043|TWO_SIDED|95.0|-2.06|-0.03||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.03|-2.06|0.043
73859855|NCT00432744|147265803|SUPERIORITY_OR_OTHER||Kendall's Tau B|0.015|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED|95.0|-0.44|0.48||Two-sided Test|Wilcoxon (Mann-Whitney)||Positive value of Tau-B would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.||0.48|-0.44|0.95
73859856|NCT00432744|147265804|SUPERIORITY_OR_OTHER||Kendall's Tau B|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.18|TWO_SIDED|95.0|-0.12|0.72|||Wilcoxon (Mann-Whitney)||A positive value would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.||0.72|-0.12|0.18
73859857|NCT00432744|147265805|SUPERIORITY_OR_OTHER|||||||0.42||||||The Hotelling T-sq=1.74 and 42% of the rerandomizations to groups of 7 and 8 had Hotelling T-sq of at least 1.74. This is the standard method for permutation tests. The large sample null is chi-sq with 2 df, which has a mean=2.|Non-parametric Hotelling T-square|||The actual study was powered to have 40 participants but only 24 participated and of these only 15 had outcome data.||||0.42
73859858|NCT01319721|147265806|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73859859|NCT01319721|147265807|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73859860|NCT01319721|147265808|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
73859861|NCT01319721|147265809|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73859862|NCT01319721|147265810|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73859863|NCT00438854|147265811|SUPERIORITY_OR_OTHER||Estimating proportion of responders|0.2||||||||||||||The primary measures of efficacy of tumor response were: complete remission (CR), nodular partial remission (nPR), or partial remission (PR), as per NCI-WG criteria. The true ORR is reported as percentage and 90% CI calculated using the binomial exact test. Time to treatment failure (TTF) was defined from the date on study to date of progression, death in remission, initiation of non-protocol therapy in the absence of progression, or censored on the last visit.||||
73859864|NCT00461305|147265815|SUPERIORITY_OR_OTHER||Incidence on one treatment arm|13.4|||||TWO_SIDED|95.0|9.73|17.77|||Binominal parameter by exact method||No group comparison were planned. Binomial parameter on each treatment arm was estimated by exact method.|Exact 95% confident intervals were calculated using F-distribution by treatment group. If the upper confidence limit is lower than 27.56% (threshold incidence), the treatment arm will be concluded to be acceptable. No group comparison was planned.||17.77|9.73|
73859865|NCT00461305|147265815|SUPERIORITY_OR_OTHER||Incidence on one treatment arm|7.1||||||95.0|1.98|17.29|||Binominal parameter by exact method|||Exact 95% confident intervals were calculated using F-distribution by treatment group.||17.29|1.98|
73859866|NCT00787930|147265861|SUPERIORITY_OR_OTHER||||||>|0.05||||||a priori threshold for significance was 0.05|Chi-squared|||||||>0.05
73859867|NCT00787930|147265862|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|df=1||||||1.00
73859868|NCT00787930|147265863|SUPERIORITY_OR_OTHER|||||||0.6056||||||No adjustment for multiple comparisons|Chi-squared|df=1||||||0.6056
73859869|NCT00787930|147265864|NON_INFERIORITY_OR_EQUIVALENCE|Exploratory hypothesis|t-stat estimated value|1.52|STANDARD_DEVIATION|8.2||0.081|ONE_SIDED|95.0|0.0||||t-test, 1 sided|missing values: 6 df=7|||||0|0.081
73859870|NCT00787930|147265865|NON_INFERIORITY_OR_EQUIVALENCE|Exploratory analyses|t-stat estimated value|1.47|STANDARD_DEVIATION|6.56||0.091|ONE_SIDED|95.0|0.0|||no adjustment for multiple analyses|t-test, 1 sided|missing values: 5 df=7|||||0|0.091
73859871|NCT02091284|147265892|OTHER||||||<|0.01||||||Two-way ANOVA with repeated measures followed by Bonferroni's multiple comparisons as post-hoc test and linear regression analyses. Additional comparisons between initial and final OCDS scores were done by paired t tests for each group.|ANOVA|||||||< 0.01
73859872|NCT02091284|147265892|OTHER||||||<|0.05|||||||t-test, 2 sided|||Additional comparisons between initial and final OCDS scores were done by paired t tests for each group, and differences between final and initial scores were compared between sham-tDCS and tDCS groups with unpaired t tests.||||<0.05
73859873|NCT01340937|147265906|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Concentration (GMC) ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.91|||||TWO_SIDED|95.0|0.77|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.08|0.77|
73859874|NCT01340937|147265906|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.86|||||TWO_SIDED|95.0|0.72|1.02|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.02|0.72|
73859875|NCT01340937|147265906|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.94|||||TWO_SIDED|95.0|0.79|1.12|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.12|0.79|
73859876|NCT01340937|147265906|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.63|||<|0.001|TWO_SIDED|95.0|1.35|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.98|1.35|<0.001
73859877|NCT01340937|147265907|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.48|||||TWO_SIDED|95.0|-4.31|3.35|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||3.35|-4.31|
74027129|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|0.95|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.40|0.95|
74027130|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.7|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.99|0.70|
74027131|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.57|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.25|0.57|
74027132|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.06|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.12|1.06|
74085866|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.065|STANDARD_ERROR_OF_MEAN|19.426||0.4091||95.0|-54.332|22.203|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||22.203|-54.332|0.4091
73859878|NCT01340937|147265907|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.62|||||TWO_SIDED|95.0|-5.38|2.12|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||2.12|-5.38|
73859879|NCT01340937|147265907|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.16|||||TWO_SIDED|95.0|-4.89|2.58|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||2.58|-4.89|
73859880|NCT01340937|147265907|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|7.93|||<|0.001|TWO_SIDED|95.0|3.38|13.17|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=1 µg/mL||13.17|3.38|<0.001
73859881|NCT01340937|147265907|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|2.2|||<|0.001|TWO_SIDED|95.0|0.39|5.12|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=0.15 µg/mL||5.12|0.39|<0.001
73859882|NCT01340937|147265908|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.87|||||TWO_SIDED|95.0|0.76|0.98|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.98|0.76|
73859883|NCT01340937|147265908|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.85|||||TWO_SIDED|95.0|0.74|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.74|
73859884|NCT01340937|147265908|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.98|||||TWO_SIDED|95.0|0.86|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.11|0.86|
73859885|NCT01340937|147265909|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.95|||||TWO_SIDED|95.0|0.84|1.07|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.07|0.84|
73859886|NCT01340937|147265909|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.97|||||TWO_SIDED|95.0|0.86|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.86|
73859887|NCT01340937|147265909|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||||TWO_SIDED|95.0|0.9|1.14|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.14|0.90|
73859888|NCT01340937|147265910|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||||TWO_SIDED|95.0|0.91|1.04|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.04|0.91|
73859889|NCT01340937|147265910|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||||TWO_SIDED|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.95|
73859890|NCT01340937|147265910|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.05|||||TWO_SIDED|95.0|0.98|1.13|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.13|0.98|
73859891|NCT01340937|147265911|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|1.03|||||TWO_SIDED|95.0|0.96|1.1|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.10|0.96|
73915412|NCT00299104|147360207|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
74027133|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.97|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.69|0.97|
74027134|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|1.8|||||TWO_SIDED|95.0|1.21|2.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.53|1.21|
74027135|NCT01025336|147607531|SUPERIORITY_OR_OTHER||Ratio of GMT|2.3|||||TWO_SIDED|95.0|1.54|3.42|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||3.42|1.54|
74027136|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.8|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.63|0.80|
74027137|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.77|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.39|0.77|
74027138|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.68|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.69|0.68|
74027139|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.03|2.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.31|1.03|
74027140|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|2.7|||||TWO_SIDED|95.0|1.66|4.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||4.55|1.66|
74085867|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.548|STANDARD_ERROR_OF_MEAN|19.388||0.4234||95.0|-53.74|22.645|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||22.645|-53.740|0.4234
74085868|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.428|STANDARD_ERROR_OF_MEAN|16.517||0.0284||95.0|-68.972|-3.884|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||-3.884|-68.972|0.0284
73915413|NCT00299104|147360207|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
73915414|NCT02042183|147360233|OTHER|||||||0.1609||||||Cochran-Mantel-Haenszel (CMH) test stratified by baseline spontaneous bowel movement (SBM) frequency (\<1.5 or ≥1.5)|Cochran-Mantel-Haenszel|||||||0.1609
74027141|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|3.7|||||TWO_SIDED|95.0|2.25|5.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||5.94|2.25|
74027142|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|6.2|||||TWO_SIDED|95.0|3.85|9.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||9.98|3.85|
74027143|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|4.2|||||TWO_SIDED|95.0|2.43|7.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||7.40|2.43|
74027144|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.89|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.13|0.89|
74027145|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.06|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.57|1.06|
74085869|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-28.985|STANDARD_ERROR_OF_MEAN|16.57||0.0816||95.0|-61.632|3.663|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||3.663|-61.632|0.0816
73915415|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|1.08|||<|0.001|TWO_SIDED|95.0|1.05|1.11||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. Age was treated as a continuous variable in years.|Regression, Cox||The hazard ratio represented the effect of a one year increase in age on a patient's risk of developing AF. Descriptive statistics (mean±standard deviation) for age were 75.7±7.9 years among patients with AF, and 69.4±10.0 among patients without AF|The null hypothesis was that age did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.11|1.05|< 0.001
73915416|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.02|TWO_SIDED|95.0|1.01|1.08||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. BMI was treated as a continuous variable.|Regression, Cox||The hazard ratio represented the effect of a one unit increase in BMI on a patient's risk of developing AF. Descriptive statistics (mean ± standard deviation) for BMI were 31.0 ± 6.6 among patients with AF, and 31.2 ± 6.4 among patients without AF|The null hypothesis was that body mass index (BMI) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.08|1.01|0.02
73915417|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.56|TWO_SIDED|95.0|0.77|1.61||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of being male on a patient's risk of developing AF.|The null hypothesis was that gender did not influence a patient's risk of experiencing AF (it's coefficient for being male in a Cox proportional hazards model was 0).||1.61|0.77|0.56
73915418|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.66|TWO_SIDED|95.0|0.74|1.59||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having diabetes on a patient's risk of developing AF.|The null hypothesis was that diabetes did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.59|0.74|0.66
73915419|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.73|TWO_SIDED|95.0|0.69|1.69||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having heart failure on a patient's risk of developing AF.|The null hypothesis was that heart failure did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.69|0.69|0.73
73915420|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.58|TWO_SIDED|95.0|0.58|2.6||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having hypertension on a patient's risk of developing AF.|The null hypothesis was that hypertension did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||2.60|0.58|0.58
73915421|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.65|TWO_SIDED|95.0|0.64|1.32||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having renal impairment on a patient's risk of developing AF.|The null hypothesis was that renal impairment did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.32|0.64|0.65
73915422|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.22|TWO_SIDED|95.0|0.45|1.2||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having COPD on a patient's risk of developing AF.|The null hypothesis was that Chronic obstructive pulmonary disease (COPD) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.20|0.45|0.22
73915423|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.53|TWO_SIDED|95.0|0.54|1.38||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a prior stroke (more than one year pre-device implant) on a patient's risk of developing AF.|The null hypothesis was that prior stroke more than one year pre-device implant did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.38|0.54|0.53
73965963|NCT01631214|147468208|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.49|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.37|0.64|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.64|0.37|<0.001
73965964|NCT01631214|147468208|SUPERIORITY||Risk Ratio (RR)|0.52|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.4|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.66|0.40|
73965965|NCT01631214|147468208|SUPERIORITY||Absolute risk reduction|4.44|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|2.8|6.08||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||6.08|2.80|
74085870|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.759|STANDARD_ERROR_OF_MEAN|11.752||0.8147||95.0|-20.446|25.964|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||25.964|-20.446|0.8147
74085871|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.182|STANDARD_ERROR_OF_MEAN|11.589||0.7187||95.0|-27.064|18.7|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||18.700|-27.064|0.7187
73965966|NCT01631214|147468209|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.73|STANDARD_ERROR_OF_MEAN|0.11||0.004|TWO_SIDED|95.0|0.59|0.9|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.90|0.59|0.004
73915424|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.21|TWO_SIDED|95.0|0.53|1.15||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having coronary artery disease on a patient's risk of developing AF.|The null hypothesis was that coronary artery disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.15|0.53|0.21
73965967|NCT01631214|147468210|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.62|STANDARD_ERROR_OF_MEAN|0.2||0.015|TWO_SIDED|95.0|0.42|0.92|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.92|0.42|0.015
73965968|NCT01631214|147468211|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.25||0.008|TWO_SIDED|95.0|0.31|0.85|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.85|0.31|0.008
73965969|NCT01631214|147468211|SUPERIORITY||Risk Ratio (RR)|0.52|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|0.32|0.85|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.85|0.32|
73965970|NCT01631214|147468211|SUPERIORITY||Absolute risk reduction|1.21|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|0.33|2.1||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||2.10|0.33|
73965971|NCT01631214|147468212|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|STANDARD_ERROR_OF_MEAN|0.11||0.005|TWO_SIDED|95.0|0.59|0.91|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.91|0.59|0.005
73915425|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.19|TWO_SIDED|95.0|0.45|1.17||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having sleep apnea on a patient's risk of developing AF.|The null hypothesis was that sleep apnea did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.17|0.45|0.19
73965972|NCT01631214|147468213|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.81|STANDARD_ERROR_OF_MEAN|0.12||0.074|TWO_SIDED|95.0|0.64|1.02|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.02|0.64|0.074
73965973|NCT01631214|147468214|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.24||0.17|TWO_SIDED|95.0|0.46|1.15|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.15|0.46|0.17
73965974|NCT01631214|147468215|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.41|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|0.24|0.71|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.71|0.24|<0.001
74085872|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.356|STANDARD_ERROR_OF_MEAN|10.148||0.7416||95.0|-23.516|16.804|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||16.804|-23.516|0.7416
74085873|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.574|STANDARD_ERROR_OF_MEAN|9.283||0.2577||95.0|-29.017|7.869|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||7.869|-29.017|0.2577
74085874|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|17.387||0.9982||95.0|-36.431|36.352|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||36.352|-36.431|0.9982
73915426|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|1.97||||0.16|TWO_SIDED|95.0|0.76|5.14||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a family history of AF on a patient's risk of developing AF.|The null hypothesis was that family history of AF did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||5.14|0.76|0.16
73915427|NCT01727297|147360236|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.63|TWO_SIDED|95.0|0.56|1.43||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having vascular disease on a patient's risk of developing AF.|The null hypothesis was that vascular disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.43|0.56|0.63
73915428|NCT02864498|147360238|SUPERIORITY|||||||0.557|||||||General Linear Model|||||||0.5570
73915429|NCT02864498|147360238|SUPERIORITY|||||||0.8774|||||||General Linear Model|||||||0.8774
73915430|NCT00378378|147360243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.258||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from basline||||0.258
73965975|NCT01631214|147468216|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.15||0.027|TWO_SIDED|95.0|0.54|0.96|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.96|0.54|0.027
73965976|NCT01631214|147468217|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.63|STANDARD_ERROR_OF_MEAN|0.18||0.008|TWO_SIDED|95.0|0.44|0.89|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.89|0.44|0.008
73915431|NCT00378378|147360243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.||||0.735
73915432|NCT00378378|147360243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.194||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.||||0.194
73915433|NCT00378378|147360244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint||||0.361
73915434|NCT00378378|147360244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.603||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.||||0.603
73915435|NCT00378378|147360244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.||||0.193
73915436|NCT04950998|147360245|SUPERIORITY||Mean Difference (Final Values)|604.07|STANDARD_DEVIATION|2560.36||0.376|TWO_SIDED|95.0|-813.815|2021.95|||t-test, 2 sided|||||2021.95|-813.815|0.376
73915437|NCT04950998|147360246|SUPERIORITY||Mean Difference (Final Values)|-35.019|STANDARD_DEVIATION|172.168||0.444|TWO_SIDED|95.0|-130.36|60.324|||t-test, 2 sided|||||60.324|-130.36|.444
73915438|NCT03782792|147360249|OTHER||Risk Difference (RD)|0.487||||0.0004|TWO_SIDED|95.0|0.215|0.672||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the primary endpoint on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.672|0.215|0.0004
73915439|NCT03782792|147360250|OTHER||Risk Difference (RD)|0.317||||0.0118|TWO_SIDED|95.0|0.022|0.527||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.527|0.022|0.0118
73915440|NCT03782792|147360251|OTHER||Risk Difference (RD)|0.346||||0.0081|TWO_SIDED|95.0|0.058|0.554||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.554|0.058|0.0081
73915441|NCT03782792|147360252|OTHER|||||||0.0012||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0012
73915442|NCT03782792|147360253|OTHER|||||||0.0044||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0044
73965977|NCT01631214|147468217|SUPERIORITY||Risk Ratio (RR)|0.64|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.46|0.89|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.89|0.46|
73859892|NCT01340937|147265911|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||||TWO_SIDED|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.95|
74027146|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|2.0|||||TWO_SIDED|95.0|1.5|2.78|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.78|1.50|
74027147|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|3.4|||||TWO_SIDED|95.0|2.3|5.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||5.04|2.30|
74027148|NCT01025336|147607532|SUPERIORITY_OR_OTHER||Ratio of GMT|2.1|||||TWO_SIDED|95.0|1.37|3.37|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||3.37|1.37|
74027149|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|0.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 1: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.90|0.48|
73859893|NCT01340937|147265911|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.06|0.92|
73859894|NCT01340937|147265911|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.2|||<|0.001|TWO_SIDED|95.0|1.11|1.29|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.29|1.11|<0.001
73859895|NCT01340937|147265912|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.89|||||TWO_SIDED|95.0|0.83|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.83|
73859896|NCT01340937|147265912|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.78|||||TWO_SIDED|95.0|0.72|0.83|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.83|0.72|
73859897|NCT01340937|147265912|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.87|||||TWO_SIDED|95.0|0.81|0.94|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.94|0.81|
73859898|NCT01340937|147265912|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.67||||0.419|TWO_SIDED|95.0|0.62|0.73|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||0.73|0.62|0.419
73859899|NCT01340937|147265913|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||||TWO_SIDED|95.0|0.87|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.87|
73859900|NCT01340937|147265913|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.93|||||TWO_SIDED|95.0|0.83|1.05|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.05|0.83|
73859901|NCT01340937|147265913|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.96|||||TWO_SIDED|95.0|0.85|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.08|0.85|
73859902|NCT01340937|147265913|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.17|0.90|<0.001
73859903|NCT01340937|147265914|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.78|||||TWO_SIDED|95.0|0.72|0.85|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.85|0.72|
73859904|NCT01340937|147265914|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.8|||||TWO_SIDED|95.0|0.73|0.87|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.87|0.73|
74085875|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.325|STANDARD_ERROR_OF_MEAN|22.184||0.5552||95.0|-59.756|33.107|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||33.107|-59.756|0.5552
73859905|NCT01340937|147265914|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.11|0.93|
73915443|NCT03782792|147360254|OTHER|||||||0.0012||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0012
74027150|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.64|1.09|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 3: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.09|0.64|
74027151|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|0.3|||||TWO_SIDED|95.0|0.2|0.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 4: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.44|0.20|
74027152|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.59|1.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 5: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.26|0.59|
74027153|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.11|0.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 6A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.26|0.11|
73915444|NCT03782792|147360255|OTHER||Risk Difference (RD)|0.375|||||TWO_SIDED|95.0|0.058|0.581|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.581|0.058|
74027154|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.49|1.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 6B: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.22|0.49|
74027155|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.68|1.76|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 7F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.76|0.68|
74027156|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|0.9|2.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 9V: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.55|0.90|
74027157|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.3|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 14: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.30|1.02|
74027158|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.52|1.14|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 18C: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.14|0.52|
74027159|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.62|1.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 19A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.08|0.62|
73915445|NCT03782792|147360256|OTHER||Risk Difference (RD)|0.403|||||TWO_SIDED|95.0|0.096|0.607|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.607|0.096|
73915446|NCT03782792|147360257|OTHER||Risk Difference (RD)|0.432|||||TWO_SIDED|95.0|0.096|0.636|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.636|0.096|
73915447|NCT03782792|147360259|OTHER||Risk Difference (RD)|0.151|||||TWO_SIDED|95.0|-0.138|0.401|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.401|-0.138|
73915448|NCT03782792|147360260|OTHER||Median Difference (Final Values)|-16.88|||||TWO_SIDED|95.0|-67.32|12.76|||||Median difference was calculated by modified Hodges-Lehmann method.|Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 and assigned with the worst possible outcomes in rank analysis. Missing data at Week 4 were imputed and handled via assessment of ranks.||12.76|-67.32|
73915449|NCT00370032|147360272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.131||95.0|-18.4|2.157|||paired t-test Hommel-Simes|||||2.157|-18.4|0.131
73915450|NCT00370032|147360272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.11||||0.131||95.0|-21.2|2.997|||paired t-test Hommel-Simes|||||2.997|-21.2|0.131
74027160|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.89|1.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 19F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.98|0.89|
74027161|NCT01025336|147607533|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.26|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 23F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.59|0.26|
73915451|NCT01537393|147360313|NON_INFERIORITY|The two treatment groups will be declared equivalent if the one-sided 95% confidence interval for the difference in proportions excludes the pre-defined non-inferiority limit of 4%.|Risk Difference (RD)|3.2|||||ONE_SIDED|95.0||5.4|||||||The bootstrap re-sampling technique were used to account for potentially correlated data from donors who donated both corneas in this study and potentially correlated data from 2 study eyes of the same study participant. The technique will sample with replacement from the observed dataset. Confidence intervals will be calculated using the bias-corrected and accelerated method. The number of bootstraps will be 100,000.|5.4||
73915452|NCT01537393|147360313|OTHER|Confounding and treatment interactions were assessed in Cox proportional hazards regression models|Hazard Ratio (HR)|1.71||||0.02|TWO_SIDED|95.0|1.09|2.71|||Regression, Cox|Unadjusted Hazard Ratio||||2.71|1.09|0.02
73915453|NCT01537393|147360314|OTHER|The primary analysis to assess the effect of PT on 3 year ECD was conducted with a mixed linear model adjusting for baseline ECD, corneal diagnosis, and potential confounders, including storage solution, preparation by eye bank vs surgeon, and accounting for correlated data from participants with 2 study eyes or 2 corneas from the same donor.|Mean Difference (Final Values)|73.0||||0.03|TWO_SIDED|95.0|8.0|138.0|||Mixed Models Analysis|Adjusted for baseline ECD, diagnosis, storage solution, preparation by eye bank/surgeon, participants with 2 study eyes/ 2 corneas from the same donor||||138|8|0.03
73915454|NCT04518293|147360317|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using a mixed model for repeated measures (MMRM).|LS Means Difference|-5.44|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-6.774|-4.107|||MIANALYZE procedure|||The LS means (LSM) difference (95% CI) in home seated SBP reduction was calculated between GMRx2 and dual-TA arms.||-4.107|-6.774|<.0001
73915455|NCT04518293|147360317|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.|LS Means Difference|-2.49|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-3.723|-1.251|||MIANALYZE procedure|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.251|-3.723|<.0001
73915456|NCT04518293|147360317|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.|LS Means Difference|-4.42|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-5.758|-3.091|||MIANALYZE procedure|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.091|-5.758|<.0001
73915457|NCT04518293|147360318|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using a MMRM.|LS Means Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.863|<|0.0001|TWO_SIDED|95.0|-7.307|-3.902|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 between dual-TA arms.||-3.902|-7.307|<.0001
73915458|NCT04518293|147360318|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.|LS Means Difference|-4.33|STANDARD_ERROR_OF_MEAN|1.212||0.0005|TWO_SIDED|95.0|-6.718|-1.933|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.933|-6.718|0.0005
73915459|NCT04518293|147360318|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.|LS Means Difference|-6.33|STANDARD_ERROR_OF_MEAN|0.837|<|0.0001|TWO_SIDED|95.0|-7.984|-4.68|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.||-4.680|-7.984|<.0001
73915460|NCT04518293|147360319|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-5.01|STANDARD_ERROR_OF_MEAN|0.858|<|0.0001|TWO_SIDED|95.0|-6.703|-3.317|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TA arms.||-3.317|-6.703|<.0001
73915461|NCT04518293|147360319|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.91||0.0002|TWO_SIDED|95.0|-5.293|-1.7|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.700|-5.293|0.0002
73915462|NCT04518293|147360319|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-5.35|STANDARD_ERROR_OF_MEAN|0.965|<|0.0001|TWO_SIDED|95.0|-7.251|-3.444|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.444|-7.251|<.0001
73915463|NCT04518293|147360320|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-3.72|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-4.692|-2.757|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.757|-4.692|<.0001
73915464|NCT04518293|147360320|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-3.51|STANDARD_ERROR_OF_MEAN|0.702|<|0.0001|TWO_SIDED|95.0|-4.897|-2.128|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TI arms.||-2.128|-4.897|<.0001
73915465|NCT04518293|147360320|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.665|<|0.0001|TWO_SIDED|95.0|-5.812|-3.189|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-AI arms.||-3.189|-5.812|<.0001
73915466|NCT04518293|147360321|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.487|<|0.0001|TWO_SIDED|95.0|-3.392|-1.469|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TA arms.||-1.469|-3.392|<.0001
73915467|NCT04518293|147360321|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.29|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-3.371|-1.201|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.201|-3.371|<.0001
74027162|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.22|0.85|
73915468|NCT04518293|147360321|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-3.77|STANDARD_ERROR_OF_MEAN|0.562|<|0.0001|TWO_SIDED|95.0|-4.882|-2.664|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.664|-4.882|<.0001
73915469|NCT04518293|147360322|OTHER||Risk Difference (RD)|12.52||||0.0003|TWO_SIDED|95.0|5.63|19.487|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||19.487|5.630|0.0003
73915470|NCT04518293|147360322|OTHER||Risk Difference (RD)|13.36||||0.0001|TWO_SIDED|95.0|6.392|20.394|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||20.394|6.392|0.0001
73915471|NCT04518293|147360322|OTHER||Risk Difference (RD)|20.97|||<|0.0001|TWO_SIDED|95.0|13.812|28.013|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||28.013|13.812|<.0001
73915472|NCT04518293|147360323|OTHER||Risk Difference (RD)|10.31||||0.0044|TWO_SIDED|95.0|3.044|17.535|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||17.535|3.044|0.0044
73915473|NCT04518293|147360323|OTHER||Risk Difference (RD)|8.08||||0.0262|TWO_SIDED|95.0|0.804|15.373|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||15.373|0.804|0.0262
73915474|NCT04518293|147360323|OTHER||Risk Difference (RD)|18.59|||<|0.0001|TWO_SIDED|95.0|11.201|25.746|||Wald test|||The difference between GMRx2 and AI at Week 6 was estimated using Generalized Estimating Equation.||25.746|11.201|<.0001
73915475|NCT04518293|147360324|OTHER||Risk Difference (RD)|16.51|||<|0.0001|TWO_SIDED|95.0|9.707|22.837|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||22.837|9.707|<.0001
73915476|NCT04518293|147360324|OTHER||Risk Difference (RD)|12.03||||0.0004|TWO_SIDED|95.0|4.982|18.658|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||18.658|4.982|0.0004
73915477|NCT04518293|147360324|OTHER||Risk Difference (RD)|18.19|||<|0.0001|TWO_SIDED|95.0|11.412|24.432|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||24.432|11.412|<.0001
74027163|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.10|0.82|
73965978|NCT01631214|147468217|SUPERIORITY||Absolute risk reduction|1.84|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|0.51|3.17||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||3.17|0.51|
74085876|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.0|STANDARD_ERROR_OF_MEAN|24.655||0.2032||95.0|-118.463|38.463|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours||38.463|-118.463|0.2032
73915478|NCT04518293|147360325|OTHER||Risk Difference (RD)|10.45||||0.0007|TWO_SIDED|95.0|3.993|16.433|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||16.433|3.993|0.0007
73915479|NCT04518293|147360325|OTHER||Risk Difference (RD)|8.93||||0.0046|TWO_SIDED|95.0|2.337|15.058|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||15.058|2.337|0.0046
73915480|NCT04518293|147360325|OTHER||Risk Difference (RD)|12.19|||<|0.0001|TWO_SIDED|95.0|5.792|18.073|||Wald test|||||18.073|5.792|<.0001
73915481|NCT04518293|147360326|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-6.11|STANDARD_ERROR_OF_MEAN|0.495|<|0.0001|TWO_SIDED|95.0|-7.086|-5.144|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TA arms.||-5.144|-7.086|<.0001
73915482|NCT04518293|147360326|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.543|<|0.0001|TWO_SIDED|95.0|-4.06|-1.932|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.932|-4.060|<.0001
73915483|NCT04518293|147360326|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-5.09|STANDARD_ERROR_OF_MEAN|0.603|<|0.0001|TWO_SIDED|95.0|-6.274|-3.912|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.912|-6.274|<.0001
73915484|NCT04518293|147360327|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-3.35|STANDARD_ERROR_OF_MEAN|0.364|<|0.0001|TWO_SIDED|95.0|-4.069|-2.632|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.632|-4.069|<.0001
73915485|NCT04518293|147360327|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.456|<|0.0001|TWO_SIDED|95.0|-2.998|-1.2|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.200|-2.998|<.0001
73915486|NCT04518293|147360327|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-3.63|STANDARD_ERROR_OF_MEAN|0.499|<|0.0001|TWO_SIDED|95.0|-4.617|-2.649|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.649|-4.617|<.0001
73915487|NCT04518293|147360328|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-3.52|STANDARD_ERROR_OF_MEAN|0.311|<|0.0001|TWO_SIDED|95.0|-4.137|-2.908|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.908|-4.137|<.0001
73915488|NCT04518293|147360328|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.361|<|0.0001|TWO_SIDED|95.0|-2.803|-1.376|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.376|-2.803|<.0001
73915489|NCT04518293|147360328|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-3.58|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|-4.446|-2.713|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.713|-4.446|<.0001
74085877|NCT00442546|147725958|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-138.5|STANDARD_ERROR_OF_MEAN|37.661||0.0348||95.0|-258.354|-18.646|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours||-18.646|-258.354|0.0348
73915490|NCT04518293|147360329|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-5.58|STANDARD_ERROR_OF_MEAN|0.713|<|0.0001|TWO_SIDED|95.0|-6.983|-4.169|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.||-4.169|-6.983|<.0001
73915491|NCT04518293|147360329|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.662||0.0043|TWO_SIDED|95.0|-3.218|-0.607|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.||-0.607|-3.218|0.0043
73915492|NCT04518293|147360329|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-3.74|STANDARD_ERROR_OF_MEAN|0.745|<|0.0001|TWO_SIDED|95.0|-5.214|-2.274|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.||-2.274|-5.214|<.0001
74027164|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.41|
74027165|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|0.87|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.87|0.67|
74027166|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.48|
74027167|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.32|2.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.19|1.32|
74027168|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.24|2.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.26|1.24|
73915493|NCT04518293|147360330|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-6.25|STANDARD_ERROR_OF_MEAN|0.546|<|0.0001|TWO_SIDED|95.0|-7.324|-5.168|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.||-5.168|-7.324|<.0001
74027169|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.48|2.95|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.95|1.48|
74085878|NCT00442546|147725959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.136|STANDARD_ERROR_OF_MEAN|4.499||0.3602||95.0|-4.79|13.062|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2||13.062|-4.790|0.3602
73915494|NCT04518293|147360330|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.72|STANDARD_ERROR_OF_MEAN|0.616|<|0.0001|TWO_SIDED|95.0|-3.941|-1.507|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.507|-3.941|<.0001
73915495|NCT04518293|147360330|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-4.43|STANDARD_ERROR_OF_MEAN|0.537|<|0.0001|TWO_SIDED|95.0|-5.489|-3.368|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.368|-5.489|<.0001
74027170|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.23|2.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.05|1.23|
74085879|NCT00442546|147725959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.573|STANDARD_ERROR_OF_MEAN|4.637||0.7352||95.0|-7.626|10.771|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2||10.771|-7.626|0.7352
73915496|NCT04518293|147360331|OTHER||Risk Difference (RD)|14.79|||<|0.0001|TWO_SIDED|95.0|7.749|21.824|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||21.824|7.749|<.0001
73915497|NCT04518293|147360331|OTHER||Risk Difference (RD)|8.46||||0.0146|TWO_SIDED|95.0|1.58|15.501|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||15.501|1.580|0.0146
73915498|NCT04518293|147360331|OTHER||Risk Difference (RD)|16.07|||<|0.0001|TWO_SIDED|95.0|8.953|23.171|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||23.171|8.953|<.0001
73915499|NCT04518293|147360332|OTHER||Risk Difference (RD)|18.11|||<|0.0001|TWO_SIDED|95.0|10.778|25.226|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||25.226|10.778|<.0001
73915500|NCT04518293|147360332|OTHER||Risk Difference (RD)|6.64||||0.0674|TWO_SIDED|95.0|-0.613|13.926|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||13.926|-0.613|0.0674
73915501|NCT04518293|147360332|OTHER||Risk Difference (RD)|18.23|||<|0.0001|TWO_SIDED|95.0|10.839|25.392|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||25.392|10.839|<.0001
74027171|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.19|0.82|
74027172|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|1.07|
74085880|NCT00442546|147725959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|6.156||0.6435||95.0|-9.392|15.111|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4||15.111|-9.392|0.6435
73859906|NCT01340937|147265914|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.51|||<|0.001|TWO_SIDED|95.0|1.37|1.66|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.66|1.37|<0.001
73859907|NCT01340937|147265915|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Titer (GMT) ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.86|||||TWO_SIDED|95.0|0.76|0.96|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.76|
73859908|NCT01340937|147265915|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.88|||||TWO_SIDED|95.0|0.79|0.99|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.99|0.79|
73859909|NCT01340937|147265915|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||TWO_SIDED|95.0|0.92|1.15|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.15|0.92|
73859910|NCT01340937|147265916|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.94|||||TWO_SIDED|95.0|0.84|1.05|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.05|0.84|
73859911|NCT01340937|147265916|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.91|||||TWO_SIDED|95.0|0.82|1.02|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.02|0.82|
73859912|NCT01340937|147265916|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|0.98|||||TWO_SIDED|95.0|0.87|1.09|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.87|
73859913|NCT01340937|147265917|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|1.06|||||TWO_SIDED|95.0|0.92|1.22|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.22|0.92|
73859914|NCT01340937|147265917|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|1.09|||||TWO_SIDED|95.0|0.95|1.26|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.26|0.95|
73859915|NCT01340937|147265917|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||TWO_SIDED|95.0|0.9|1.19|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.19|0.90|
73859916|NCT01340937|147265918|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.34|||||TWO_SIDED|95.0|-1.23|0.3|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.30|-1.23|
73859917|NCT01340937|147265918|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-0.34|||||TWO_SIDED|95.0|-1.23|0.32|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.32|-1.23|
73859918|NCT01340937|147265918|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.64|0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.66|-0.64|
73859919|NCT01340937|147265918|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.92|||<|0.001|TWO_SIDED|95.0|0.2|2.9|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.90|0.20|<0.001
73859920|NCT01340937|147265919|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|0.25|||||TWO_SIDED|95.0|-3.74|4.24|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||4.24|-3.74|
73859921|NCT01340937|147265919|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.35|||||TWO_SIDED|95.0|-5.26|2.57|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.57|-5.26|
73915502|NCT04518293|147360333|OTHER||Risk Difference (RD)|17.25|||<|0.0001|TWO_SIDED|95.0|9.902|24.286|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||24.286|9.902|<.0001
74085881|NCT00442546|147725959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.237|STANDARD_ERROR_OF_MEAN|6.361||0.6123||95.0|-9.422|15.895|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4||15.895|-9.422|0.6123
73965979|NCT01631214|147468218|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.71|STANDARD_ERROR_OF_MEAN|0.11||0.002|TWO_SIDED|95.0|0.57|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.88|0.57|0.002
74027173|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.56|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.80|1.56|
74027174|NCT01025336|147607534|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.48|0.89|
74027175|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|0.92|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 1: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.92|0.48|
74027176|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.76|1.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 3: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.28|0.76|
74027177|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.88|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 4: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.22|0.88|
74027178|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.93|1.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 5: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.95|0.93|
74027179|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.27|0.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 6A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.66|0.27|
74027180|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.64|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 6B: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.56|0.64|
74085882|NCT00442546|147725959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|7.663||0.6356||95.0|-11.683|18.984|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET||18.984|-11.683|0.6356
74027181|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.14|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 7F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||3.04|1.14|
74027182|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.01|2.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 9V: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.85|1.01|
74027183|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.26|2.87|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 14: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.87|1.26|
74027184|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.57|1.19|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 18C: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.19|0.57|
74027185|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.75|1.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 19A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.31|0.75|
74027186|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.93|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 19F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.04|0.93|
74027187|NCT01025336|147607535|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.5|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 23F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.15|0.50|
73915503|NCT04518293|147360333|OTHER||Risk Difference (RD)|12.06||||0.001|TWO_SIDED|95.0|4.632|19.293|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||19.293|4.632|0.0010
73915504|NCT04518293|147360333|OTHER||Risk Difference (RD)|22.93|||<|0.0001|TWO_SIDED|95.0|15.622|29.796|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||29.796|15.622|<.0001
73915505|NCT04518293|147360334|OTHER||Risk Difference (RD)|18.59|||<|0.0001|TWO_SIDED|95.0|11.579|25.124|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||25.124|11.579|<.0001
73915506|NCT04518293|147360334|OTHER||Risk Difference (RD)|12.22||||0.0005|TWO_SIDED|95.0|4.963|19.123|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||19.123|4.963|0.0005
73915507|NCT04518293|147360334|OTHER||Risk Difference (RD)|16.2|||<|0.0001|TWO_SIDED|95.0|9.06|22.914|||Wald test|||The difference between GMRx2 and AI at Week 6 was estimated using Generalized Estimating Equation.||22.914|9.060|<.0001
73915508|NCT04518293|147360335|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.93|||||TWO_SIDED|95.0|-1.529|2.768||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TA arms.||2.768|-1.529|
73915509|NCT04518293|147360335|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-2.098|2.475||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TI arms.||2.475|-2.098|
73915510|NCT04518293|147360335|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-2.098|2.475||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-AI arms.||2.475|-2.098|
73915511|NCT04518293|147360341|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|4.07|||||TWO_SIDED|95.0|0.494|7.116||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||7.116|0.494|
73915512|NCT04518293|147360341|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.38|||||TWO_SIDED|95.0|-3.927|4.02||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||4.020|-3.927|
73915513|NCT04518293|147360341|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.64|||||TWO_SIDED|95.0|-0.07|6.764||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||6.764|-0.070|
73965980|NCT01631214|147468219|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|STANDARD_ERROR_OF_MEAN|0.16||0.057|TWO_SIDED|95.0|0.54|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.01|0.54|0.057
73965981|NCT01631214|147468220|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.64|STANDARD_ERROR_OF_MEAN|0.34||0.19|TWO_SIDED|95.0|0.33|1.26|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.26|0.33|0.19
73915514|NCT04518293|147360342|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|2.59|||||TWO_SIDED|95.0|-0.5|5.136||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||5.136|-0.500|
73915515|NCT04518293|147360342|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.82|||||TWO_SIDED|95.0|-1.513|4.517||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.517|-1.513|
73915516|NCT04518293|147360342|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.73|||||TWO_SIDED|95.0|-2.855|3.633||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||3.633|-2.855|
73915517|NCT04518293|147360343|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.06|||||TWO_SIDED|95.0|-3.911|3.129||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||3.129|-3.911|
73915518|NCT04518293|147360343|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.53|||||TWO_SIDED|95.0|-4.519|2.744||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||2.744|-4.519|
73915519|NCT04518293|147360343|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-3.228|3.647||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||3.647|-3.228|
73915520|NCT04518293|147360344|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-3.993|2.816||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||2.816|-3.993|
73915521|NCT04518293|147360344|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.82|||||TWO_SIDED|95.0|-1.513|4.517||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.517|-1.513|
73965982|NCT01631214|147468221|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.17||0.053|TWO_SIDED|95.0|0.52|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.01|0.52|0.053
73965983|NCT01631214|147468222|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.56|STANDARD_ERROR_OF_MEAN|0.39||0.14|TWO_SIDED|95.0|0.26|1.22|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.22|0.26|0.14
73965984|NCT01631214|147468223|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|7.58|8.57|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an analysis of covariance (ANCOVA) model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||8.57|7.58|<0.001
73965985|NCT01631214|147468224|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.42|4.1|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.10|3.42|<0.001
73965986|NCT01631214|147468225|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.4|4.14|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.14|3.40|<0.001
73965987|NCT01631214|147468226|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|8.31|9.09|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||9.09|8.31|<0.001
73965988|NCT01631214|147468227|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|3.03|3.6|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.60|3.03|<0.001
74027188|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.31|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.31|1.03|
73965989|NCT01631214|147468228|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|2.9|3.54|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.54|2.90|<0.001
73965990|NCT01631214|147468229|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|7.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|6.84|7.89|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||7.89|6.84|<0.001
74027189|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.37|1.07|
73915522|NCT04518293|147360344|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.72|||||TWO_SIDED|95.0|-4.596|2.44||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||2.440|-4.596|
73915523|NCT04518293|147360345|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|6.72|||||TWO_SIDED|95.0|4.196|9.222||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||9.222|4.196|
73915524|NCT04518293|147360345|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-1.883|5.257||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||5.257|-1.883|
73915525|NCT04518293|147360345|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-5.97|||||TWO_SIDED|95.0|-10.979|-1.6||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||-1.600|-10.979|
73915526|NCT04518293|147360346|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.13|||||TWO_SIDED|95.0|0.123|5.632||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||5.632|0.123|
73915527|NCT04518293|147360346|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.28|||||TWO_SIDED|95.0|-2.245|4.134||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.134|-2.245|
73915528|NCT04518293|147360346|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.71|||||TWO_SIDED|95.0|-6.968|0.819||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||0.819|-6.968|
73915529|NCT04518293|147360347|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.91|||||TWO_SIDED|95.0|-0.863|2.231||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||2.231|-0.863|
73915530|NCT04518293|147360347|OTHER||Risk Difference (RD)|0.91|||||TWO_SIDED|95.0|-0.897|2.231||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||2.231|-0.897|
73915531|NCT04518293|147360347|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-1.494|1.913||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||1.913|-1.494|
73915532|NCT04518293|147360348|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.01|||||TWO_SIDED|95.0|-1.931|1.149||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||1.149|-1.931|
73915533|NCT04518293|147360348|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.979|1.143||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||1.143|-1.979|
74027190|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.6|2.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.68|1.60|
73915534|NCT04518293|147360348|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.36|||||TWO_SIDED|95.0|-1.374|1.453||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||1.453|-1.374|
73915535|NCT04518293|147360349|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.39|||||TWO_SIDED|95.0|-2.014|2.087||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TA arms.||2.087|-2.014|
73915536|NCT04518293|147360349|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-1.015|2.633||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TI arms.||2.633|-1.015|
73915537|NCT04518293|147360349|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-1.015|2.633||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-AI arms.||2.633|-1.015|
73915538|NCT04518293|147360350|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.16|||||TWO_SIDED|95.0|-2.501|1.385||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TA arms.||1.385|-2.501|
73915539|NCT04518293|147360350|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.54|||||TWO_SIDED|95.0|-3.078|1.108||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TI arms.||1.108|-3.078|
74085883|NCT00442546|147725959|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.909|STANDARD_ERROR_OF_MEAN|7.747||0.907||95.0|-14.593|16.411|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET||16.411|-14.593|0.9070
73915540|NCT04518293|147360350|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.18|||||TWO_SIDED|95.0|-2.571|1.37||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-AI arms.||1.370|-2.571|
73915541|NCT04518293|147360351|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|10.55|||||TWO_SIDED|95.0|5.422|15.138||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TA arms.||15.138|5.422|
73915542|NCT04518293|147360351|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.11|||||TWO_SIDED|95.0|-2.776|8.49||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TI arms.||8.490|-2.776|
73915543|NCT04518293|147360351|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-7.807|4.174||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-AI arms.||4.174|-7.807|
73915544|NCT04518293|147360352|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|5.47|||||TWO_SIDED|95.0|0.531|9.867||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TA arms.||9.867|0.531|
73915545|NCT04518293|147360352|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|4.92|||||TWO_SIDED|95.0|-0.136|9.397||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TI arms.||9.397|-0.136|
73915546|NCT04518293|147360352|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-7.299|3.567||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-AI arms.||3.567|-7.299|
73915547|NCT04518293|147360353|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.06||||0.9677|TWO_SIDED|95.0|-3.825|3.019|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TA arms.||3.019|-3.825|0.9677
73965991|NCT01631214|147468230|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.29|4.02|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.02|3.29|<0.001
74027191|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.55|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.03|1.55|
74027192|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.07|0.79|
74027193|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.53|1.05|
73915548|NCT04518293|147360353|OTHER||Risk Difference (RD)|-2.35||||0.1952|TWO_SIDED|95.0|-6.55|1.125|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TI arms.||1.125|-6.550|0.1952
73915549|NCT04518293|147360353|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.53||||0.7453|TWO_SIDED|95.0|-4.428|2.642|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-AI arms.||2.642|-4.428|0.7453
73915550|NCT04518293|147360354|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.12||||0.9415|TWO_SIDED|95.0|-3.657|3.222|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TA arms.||3.222|-3.657|0.9415
73915551|NCT04518293|147360354|OTHER||Risk Difference (RD)|-2.53||||0.1719|TWO_SIDED|95.0|-6.799|1.019|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TI arms.||1.019|-6.799|0.1719
73915552|NCT04518293|147360354|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.16||||0.2342|TWO_SIDED|95.0|-6.38|1.326|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-AI arms.||1.326|-6.380|0.2342
73915553|NCT04518293|147360355|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.87||||0.3548|TWO_SIDED|95.0|-9.316|3.215|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TA arms.||3.215|-9.316|0.3548
73915554|NCT04518293|147360355|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.94||||0.7529|TWO_SIDED|95.0|-5.356|6.8|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TI arms.||6.800|-5.356|0.7529
73915555|NCT04518293|147360355|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.32||||0.4563|TWO_SIDED|95.0|-8.791|3.772|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-AI arms.||3.772|-8.791|0.4563
73915556|NCT04518293|147360356|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.11||||0.9691|TWO_SIDED|95.0|-6.063|5.859|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TA arms.||5.859|-6.063|0.9691
73915557|NCT04518293|147360356|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-3.59||||0.2454|TWO_SIDED|95.0|-10.018|2.462|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TI arms.||2.462|-10.018|0.2454
73915558|NCT04518293|147360356|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.33||||0.913|TWO_SIDED|95.0|-6.583|5.488|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-AI arms.||5.488|-6.583|0.9130
73915559|NCT03129100|147360367|SUPERIORITY||Odds Ratio (OR)|4.35|||<|0.001|TWO_SIDED|95.0|2.03|9.35|||Regression, Logistic|||||9.35|2.03|<0.001
73915560|NCT03129100|147360368|SUPERIORITY||Odds Ratio (OR)|4.28||||0.003|TWO_SIDED|95.0|1.66|11.03|||Regression, Logistic|||||11.03|1.66|0.003
73915561|NCT03129100|147360368|SUPERIORITY||Odds Ratio (OR)|4.42||||0.001|TWO_SIDED|95.0|1.77|11.02|||Regression, Logistic|||||11.02|1.77|0.001
73915562|NCT03129100|147360370|SUPERIORITY||Odds Ratio (OR)|4.51||||0.001|TWO_SIDED|95.0|1.78|11.41|||Regression, Logistic|||||11.41|1.78|0.001
73915563|NCT03129100|147360370|SUPERIORITY||Odds Ratio (OR)|4.61|||<|0.001|TWO_SIDED|95.0|1.88|11.31|||Regression, Logistic|||||11.31|1.88|<0.001
73915564|NCT03129100|147360371|SUPERIORITY||Odds Ratio (OR)|5.17|||<|0.001|TWO_SIDED|95.0|2.11|12.69|||Regression, Logistic|||||12.69|2.11|<0.001
73915565|NCT03129100|147360371|SUPERIORITY||Odds Ratio (OR)|5.23|||<|0.001|TWO_SIDED|95.0|2.2|12.47|||Regression, Logistic|||||12.47|2.20|<0.001
73915566|NCT03129100|147360372|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|1.9|11.17|||Regression, Logistic|||||11.17|1.90|<0.001
73965992|NCT01631214|147468231|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.18|3.97|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.97|3.18|<0.001
74027194|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.6|||||TWO_SIDED|95.0|1.98|3.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.50|1.98|
74027195|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.37|2.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.61|1.37|
74027196|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.33|1.86|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.86|1.33|
74027197|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.1|1.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.10|
73915567|NCT03129100|147360372|SUPERIORITY||Odds Ratio (OR)|3.55||||0.003|TWO_SIDED|95.0|1.56|8.09|||Regression, Logistic|||||8.09|1.56|0.003
73915568|NCT03129100|147360373|SUPERIORITY||Odds Ratio (OR)|4.92|||<|0.001|TWO_SIDED|95.0|2.07|11.72|||Regression, Logistic|||||11.72|2.07|<0.001
73915569|NCT03129100|147360373|SUPERIORITY||Odds Ratio (OR)|3.61||||0.003|TWO_SIDED|95.0|1.57|8.32|||Regression, Logistic|||||8.32|1.57|0.003
73915570|NCT03129100|147360374|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-3.1|-1.1|||ANCOVA|||Patient Global||-1.1|-3.1|<0.001
73915571|NCT03129100|147360374|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-2.9|-1.0|||ANCOVA|||Patient Global||-1.0|-2.9|<0.001
73915572|NCT03129100|147360374|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-3.1|-1.0|||ANCOVA|||Spinal Pain||-1.0|-3.1|<0.001
73915573|NCT03129100|147360374|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-2.8|-0.8|||ANCOVA|||Spinal Pain||-0.8|-2.8|<0.001
73915574|NCT03129100|147360374|SUPERIORITY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.421|<|0.001|TWO_SIDED|95.0|-2.39|-0.72|||ANCOVA|||BASFI||-0.72|-2.39|<0.001
73915575|NCT03129100|147360374|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.409|<|0.001|TWO_SIDED|95.0|-2.2|-0.59|||ANCOVA|||BASFI||-0.59|-2.20|<0.001
73915576|NCT03129100|147360374|SUPERIORITY||LS Mean Difference|-2.17|STANDARD_ERROR_OF_MEAN|0.448|<|0.001|TWO_SIDED|95.0|-3.05|-1.28|||ANCOVA|||Inflammation||-1.28|-3.05|<0.001
73915577|NCT03129100|147360374|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.433|<|0.001|TWO_SIDED|95.0|-2.66|-0.95|||ANCOVA|||Inflammation||-0.95|-2.66|<0.001
73915578|NCT03129100|147360375|SUPERIORITY||Odds Ratio (OR)|5.34|||<|0.001|TWO_SIDED|95.0|2.13|13.35|||Regression, Logistic|||||13.35|2.13|<0.001
73965993|NCT03857620|147468248|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.53|TWO_SIDED|95.0|-0.85|0.45|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||Combined Arm II (OPTI-Surg) \& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)||0.45|-0.85|0.53
74085884|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1190.65|STANDARD_ERROR_OF_MEAN|123.062||0.0656||95.0|-2754.304|373.004|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours||373.004|-2754.304|0.0656
73965994|NCT03857620|147468248|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.84|TWO_SIDED|95.0|-0.67|0.81|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||0.81|-0.67|0.84
73965995|NCT03857620|147468248|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.19|TWO_SIDED|95.0|-1.21|0.26|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||0.26|-1.21|0.19
73965996|NCT03857620|147468248|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.14|TWO_SIDED|95.0|-0.19|1.29|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||1.29|-0.19|0.14
73965997|NCT03857620|147468249|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5|TWO_SIDED|95.0|0.23|2.09|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||Combined Arm II (OPTI-Surg) \& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)||2.09|0.23|0.50
73965998|NCT03857620|147468249|SUPERIORITY||Odds Ratio (OR)|0.46||||0.21|TWO_SIDED|95.0|0.13|1.62|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||1.62|0.13|0.21
73965999|NCT03857620|147468249|SUPERIORITY||Odds Ratio (OR)|1.03||||0.96|TWO_SIDED|95.0|0.3|3.54|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||3.54|0.30|0.96
74027198|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.14|
74027199|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.2|||||TWO_SIDED|95.0|1.8|2.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.60|1.80|
74085885|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.2|STANDARD_ERROR_OF_MEAN|142.1||0.9277||95.0|-1789.352|1821.752|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours||1821.752|-1789.352|0.9277
73966000|NCT03857620|147468249|SUPERIORITY||Odds Ratio (OR)|0.45||||0.19|TWO_SIDED|95.0|0.13|1.54|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||1.54|0.13|0.19
73966001|NCT00567398|147468255|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
73966002|NCT00567398|147468255|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
73966003|NCT00567398|147468256|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
73966004|NCT00567398|147468256|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
73966005|NCT00567398|147468258|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
73966006|NCT00567398|147468258|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
73966007|NCT00567398|147468258|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
73966008|NCT00567398|147468258|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
73966009|NCT00567398|147468258|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
73966010|NCT00567398|147468258|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
73966011|NCT00567398|147468258|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
73966012|NCT00567398|147468258|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
73966013|NCT00567398|147468258|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
73966014|NCT00567398|147468258|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
73966015|NCT00567398|147468259|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
74027200|NCT01025336|147607536|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.44|2.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.06|1.44|
74027201|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|1.2|||||TWO_SIDED|95.0|0.87|1.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.64|0.87|
73915579|NCT03129100|147360375|SUPERIORITY||Odds Ratio (OR)|4.07||||0.001|TWO_SIDED|95.0|1.75|9.45|||Regression, Logistic|||||9.45|1.75|0.001
73915580|NCT03129100|147360376|SUPERIORITY||LS Mean Difference|-7.858|STANDARD_ERROR_OF_MEAN|1.9586|<|0.001|TWO_SIDED|95.0|-11.729|-3.987|||ANCOVA|||||-3.987|-11.729|<0.001
73915581|NCT03129100|147360376|SUPERIORITY||LS Mean Difference|-5.979|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|-9.655|-2.304|||ANCOVA|||||-2.304|-9.655|0.002
73915582|NCT03129100|147360377|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.104||0.062|TWO_SIDED|95.0|-0.4|0.01|||ANCOVA|||||0.01|-0.40|0.062
73915583|NCT03129100|147360377|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.099||0.018|TWO_SIDED|95.0|-0.43|-0.04|||ANCOVA|||||-0.04|-0.43|0.018
73915584|NCT03129100|147360378|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.335||0.757|TWO_SIDED|95.0|-0.56|0.77|||ANCOVA|||||0.77|-0.56|0.757
73915585|NCT03129100|147360378|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.322||0.67|TWO_SIDED|95.0|-0.77|0.5|||ANCOVA|||||0.50|-0.77|0.670
73915586|NCT03129100|147360379|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.338||0.236|TWO_SIDED|95.0|-1.07|0.27|||ANCOVA|||||0.27|-1.07|0.236
73915587|NCT03129100|147360379|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.319||0.373|TWO_SIDED|95.0|-0.92|0.35|||ANCOVA|||||0.35|-0.92|0.373
73915588|NCT03129100|147360380|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.459||0.885|TWO_SIDED|95.0|-0.98|0.85|||ANCOVA|||||0.85|-0.98|0.885
73915589|NCT03129100|147360380|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.41||0.735|TWO_SIDED|95.0|-0.95|0.68|||ANCOVA|||||0.68|-0.95|0.735
73915590|NCT03129100|147360381|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.501||0.294|TWO_SIDED|95.0|-1.53|0.47|||ANCOVA|||||0.47|-1.53|0.294
73915591|NCT03129100|147360381|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.453||0.164|TWO_SIDED|95.0|-1.54|0.27|||ANCOVA|||||0.27|-1.54|0.164
73915592|NCT03129100|147360382|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.1||0.063|TWO_SIDED|95.0|-4.3|0.1|||ANCOVA|||||0.1|-4.3|0.063
73915593|NCT03129100|147360382|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.02||0.211|TWO_SIDED|95.0|-3.3|0.7|||ANCOVA|||||0.7|-3.3|0.211
73915594|NCT03129100|147360383|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.9||0.334|TWO_SIDED|95.0|-2.7|0.9|||ANCOVA|||||0.9|-2.7|0.334
73915595|NCT03129100|147360383|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.88||0.168|TWO_SIDED|95.0|-3.0|0.5|||ANCOVA|||||0.5|-3.0|0.168
73915596|NCT03129100|147360385|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.1|TWO_SIDED|95.0|-1.5|0.1|||ANCOVA|||||0.1|-1.5|0.100
73915597|NCT03129100|147360385|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.38||0.047|TWO_SIDED|95.0|-1.5|0.0|||ANCOVA|||||-0.0|-1.5|0.047
73915598|NCT03129100|147360386|SUPERIORITY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.479||0.068|TWO_SIDED|95.0|-1.83|0.06|||ANCOVA|||||0.06|-1.83|0.068
73915599|NCT03129100|147360386|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.465||0.307|TWO_SIDED|95.0|-1.4|0.44|||ANCOVA|||||0.44|-1.40|0.307
73915600|NCT03129100|147360387|SUPERIORITY||LS Mean Difference|2.6021|STANDARD_ERROR_OF_MEAN|1.4684||0.079|TWO_SIDED|95.0|-0.3011|5.5053|||ANCOVA|||||5.5053|-0.3011|0.079
73915601|NCT03129100|147360387|SUPERIORITY||LS Mean Difference|2.4096|STANDARD_ERROR_OF_MEAN|1.3978||0.087|TWO_SIDED|95.0|-0.3541|5.1734|||ANCOVA|||||5.1734|-0.3541|0.087
73915602|NCT03129100|147360388|SUPERIORITY||LS Mean Difference|0.837|STANDARD_ERROR_OF_MEAN|1.1752||0.477|TWO_SIDED|95.0|-1.4864|3.1605|||ANCOVA|||||3.1605|-1.4864|0.477
73915603|NCT03129100|147360388|SUPERIORITY||LS Mean Difference|2.3009|STANDARD_ERROR_OF_MEAN|1.1192||0.042|TWO_SIDED|95.0|0.088|4.5138|||ANCOVA|||||4.5138|0.0880|0.042
73915604|NCT03129100|147360389|SUPERIORITY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.52||0.058|TWO_SIDED|95.0|-2.02|0.04|||ANCOVA|||||0.04|-2.02|0.058
73915605|NCT03129100|147360389|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.497||0.147|TWO_SIDED|95.0|-1.71|0.26|||ANCOVA|||||0.26|-1.71|0.147
73915606|NCT03129100|147360390|SUPERIORITY||LS Mean Difference|0.0418|STANDARD_ERROR_OF_MEAN|0.0334||0.213|TWO_SIDED|95.0|-0.0329|0.1164|||ANCOVA|||||0.1164|-0.0329|0.213
73915607|NCT03129100|147360390|SUPERIORITY||LS Mean Difference|0.0388|STANDARD_ERROR_OF_MEAN|0.0319||0.225|TWO_SIDED|95.0|-0.0324|0.1101|||ANCOVA|||||0.1101|-0.0324|0.225
73915608|NCT03129100|147360391|SUPERIORITY||LS Mean Difference|-10.62|STANDARD_ERROR_OF_MEAN|4.383||0.017|TWO_SIDED|95.0|-19.28|-1.95|||ANCOVA|||Percentage of Activity Impairment||-1.95|-19.28|0.017
73915609|NCT03129100|147360391|SUPERIORITY||LS Mean Difference|-7.14|STANDARD_ERROR_OF_MEAN|4.199||0.091|TWO_SIDED|95.0|-15.44|1.16|||ANCOVA|||Percentage of Activity Impairment||1.16|-15.44|0.091
73915610|NCT03129100|147360392|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.66||0.531|TWO_SIDED|95.0|-1.7|0.9|||ANCOVA|||||0.9|-1.7|0.531
73915611|NCT03129100|147360392|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.743|TWO_SIDED|95.0|-1.4|1.0|||ANCOVA|||||1.0|-1.4|0.743
73915612|NCT03845985|147360395|SUPERIORITY|||||||0.838||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.838
73915613|NCT03845985|147360396|SUPERIORITY|||||||0.62||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.620
73915614|NCT03845985|147360397|SUPERIORITY|||||||0.713||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.713
73915615|NCT03845985|147360398|SUPERIORITY|||||||0.509||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.509
73915616|NCT03845985|147360399|SUPERIORITY|||||||0.491||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.491
73915617|NCT03845985|147360400|SUPERIORITY|||||||0.715||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.715
73915618|NCT03845985|147360401|SUPERIORITY|||||||0.665||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.665
73915619|NCT03845985|147360402|SUPERIORITY|||||||0.875||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.875
73915620|NCT03845985|147360403|SUPERIORITY|||||||0.61||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Risk and Aggression/Liquid Courage/Sociability Subscale||||.610
73915621|NCT03845985|147360403|SUPERIORITY|||||||0.658||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Self-Perception/Cognitive and Behavioral Impairment Subscale||||.658
74085886|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.771|STANDARD_ERROR_OF_MEAN|62.692||0.935||95.0|-263.972|275.515|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours||275.515|-263.972|0.9350
73859922|NCT01340937|147265919|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.64|||||TWO_SIDED|95.0|-5.56|2.28|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.28|-5.56|
74085887|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.243|STANDARD_ERROR_OF_MEAN|44.33||0.6139||95.0|-164.494|216.98|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours||216.980|-164.494|0.6139
73859923|NCT01340937|147265919|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-2.35|||<|0.001|TWO_SIDED|95.0|-6.02|2.09|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.09|-6.02|<0.001
73859924|NCT01340937|147265920|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|-0.16|||||TWO_SIDED|95.0|-0.91|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.47|-0.91|
73859925|NCT01340937|147265920|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|-0.16|||||TWO_SIDED|95.0|-0.9|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.47|-0.90|
73859926|NCT01340937|147265920|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.63|0.62|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.62|-0.63|
73859927|NCT01340937|147265920|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|1.28|||<|0.001|TWO_SIDED|95.0|0.46|3.33|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.33|0.46|<0.001
73859928|NCT01340937|147265921|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|1.73|||||TWO_SIDED|95.0|0.37|3.4|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||3.40|0.37|
73859929|NCT01340937|147265921|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|0.36|||||TWO_SIDED|95.0|-0.77|1.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||1.63|-0.77|
73859930|NCT01340937|147265921|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.36|||||TWO_SIDED|95.0|-3.03|0.15|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.15|-3.03|
73859931|NCT01340937|147265921|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.72|||<|0.001|TWO_SIDED|95.0|-0.59|3.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.14|-0.59|<0.001
73859932|NCT01340937|147265922|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-1.35|||||TWO_SIDED|95.0|-5.17|2.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.47|-5.17|
73859933|NCT01340937|147265922|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-3.06|||||TWO_SIDED|95.0|-6.79|0.67|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.67|-6.79|
73859934|NCT01340937|147265922|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.71|||||TWO_SIDED|95.0|-5.37|1.94|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||1.94|-5.37|
73859935|NCT01340937|147265922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-4.7|||<|0.001|TWO_SIDED|95.0|-7.73|-0.86|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||-0.86|-7.73|<0.001
73915622|NCT03845985|147360403|SUPERIORITY|||||||1||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Sexuality Subscale||||1.000
73915623|NCT03845985|147360403|SUPERIORITY|||||||0.007||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Tension Reduction Subscale||||.007
73915624|NCT03845985|147360404|SUPERIORITY|||||||0.407||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.407
73859936|NCT01340937|147265923|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|2.77|||||TWO_SIDED|95.0|-1.83|7.39|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||7.39|-1.83|
73859937|NCT01340937|147265923|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|2.41|||||TWO_SIDED|95.0|-2.21|7.06|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||7.06|-2.21|
73859938|NCT01340937|147265923|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.36|||||TWO_SIDED|95.0|-5.14|4.42|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||4.42|-5.14|
73915625|NCT03845985|147360405|SUPERIORITY|||||||0.893||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.893
73915626|NCT03845985|147360406|SUPERIORITY|||||||0.709||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.709
73915627|NCT03302234|147360422|OTHER||Hazard Ratio (HR)|1.08||||0.74156|TWO_SIDED|95.0|0.85|1.37||One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|||1.37|0.85|0.74156
73915628|NCT03302234|147360423|OTHER||Hazard Ratio (HR)|1.06||||0.7172|TWO_SIDED|95.0|0.86|1.3|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site and predominant tumor history.|||1.30|0.86|0.71720
73966016|NCT00567398|147468259|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
73966017|NCT00567398|147468259|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
73966018|NCT00567398|147468259|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
74027202|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.63|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.08|0.63|
73915629|NCT03302234|147360424|OTHER||Difference in percentage|-0.1||||0.50644|TWO_SIDED|95.0|-8.2|8.1|||Miettinen & Nurminen method|One-sided p-value for testing|Based on Miettinen \& Nurminen method stratified by ECOG, geographic region of the enrolling site and predominant tumor history.|||8.1|-8.2|0.50644
73915630|NCT03302234|147360426|OTHER||Hazard Ratio (HR)|0.9815||||0.9112|TWO_SIDED|95.0|0.7386|1.3042|||Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.|||1.3042|0.7386|0.9112
73915631|NCT03302234|147360429|OTHER||Difference in LS Means|-0.42||||0.8151|TWO_SIDED|95.0|-3.96|3.12|||cLDA Model|Constrained longitudinal data analysis (cLDA) Model|Based on a cLDA model with PRO scores as response variable, with covariates for treatment by time interaction, and stratification factors (ECOG, geographic region of the enrolling site, \& predominant tumor histology) as covariates.|||3.12|-3.96|0.8151
73915632|NCT02795832|147360430|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|12.441||0.5016|TWO_SIDED|90.0|-21.24|21.34||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Observed case||21.34|-21.24|0.5016
74027203|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.25|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.80|1.25|
74085888|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|9.96||0.776||95.0|-25.451|19.611|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours||19.611|-25.451|0.7760
73915633|NCT02795832|147360430|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-3.01|STANDARD_ERROR_OF_MEAN|12.964||0.4082|TWO_SIDED|90.0|-24.39|18.36||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Multiple imputations||18.36|-24.39|0.4082
73915634|NCT02795832|147360430|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-18.27|STANDARD_ERROR_OF_MEAN|13.138||0.0878|TWO_SIDED|90.0|-40.65|4.11||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Last observation carried forward||4.11|-40.65|0.0878
73966019|NCT00567398|147468259|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
73966020|NCT00567398|147468259|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
73966021|NCT00567398|147468260|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
73966022|NCT00567398|147468260|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
73966023|NCT00567398|147468260|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
73966024|NCT00567398|147468260|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
73966025|NCT00567398|147468261|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
73966026|NCT00567398|147468261|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
73966027|NCT00567398|147468262|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
73915635|NCT02795832|147360430|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-37.6|STANDARD_ERROR_OF_MEAN|18.748||0.0275|TWO_SIDED|90.0|-69.53|-5.66||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Worst case imputation||-5.66|-69.53|0.0275
73915636|NCT02795832|147360431|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-11.72||||0.1284|TWO_SIDED|90.0|-28.85|5.51||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 5||5.51|-28.85|0.1284
73915637|NCT02795832|147360431|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-5.95||||0.2765|TWO_SIDED|90.0|-22.85|10.95||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 8||10.95|-22.85|0.2765
73915638|NCT02795832|147360431|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-6.01||||0.2765|TWO_SIDED|90.0|-23.08|11.06||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 10||11.06|-23.08|0.2765
73915639|NCT02795832|147360431|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05||||0.5016|TWO_SIDED|90.0|-21.24|21.34|||ANCOVA|||Day 15||21.34|-21.24|0.5016
73915640|NCT02795832|147360432|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|1.55||||0.4789|TWO_SIDED|90.0|0.28|10.75||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|ANCOVA|||EASI 50||10.75|0.28|0.4789
73915641|NCT02795832|147360432|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|2.0||||0.3|TWO_SIDED|90.0|0.24|999.0||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|ANCOVA|||EASI-75||999|0.24|0.3000
73915642|NCT02795832|147360433|SUPERIORITY||Odds Ratio (OR)|0.45||||0.5|TWO_SIDED|95.0|0.01|19.2||Results for the ZPL-5212372 and placebo groups are estimated adjusted LS means from the fitted model.|Shapiro-Wilkes test|The p-value tests if the residuals are normally distributed.||||19.20|0.01|0.500
73915643|NCT02795832|147360434|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_DEVIATION|1.22||0.5233|TWO_SIDED|90.0|-2.02|2.16|||Shapiro-Wilkes test|||||2.16|-2.02|0.5233
73915644|NCT02795832|147360435|SUPERIORITY||Odds Ratio (OR)|2.43||||0.2455|TWO_SIDED|95.0|0.45|13.26|||t-test, 1 sided|||||13.26|0.45|0.2455
73915645|NCT02795832|147360436|SUPERIORITY||Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|4.521||0.2812|TWO_SIDED|90.0|-10.4|5.09||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|Shapiro-Wilkes test|||||5.09|-10.40|0.2812
73915646|NCT04523220|147360440|OTHER||Cox Proportional Hazard|0.59|||=|0.222|TWO_SIDED|90.0|0.28|1.21||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.21|0.28|= 0.222
73915647|NCT04523220|147360440|OTHER||Cox Proportional Hazard|0.72|||=|0.427|TWO_SIDED|90.0|0.36|1.42||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.42|0.36|= 0.427
73915648|NCT04523220|147360441|OTHER||Cox Proportional Hazard|1.27|||=|0.128|TWO_SIDED|90.0|0.98|1.64||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.64|0.98|= 0.128
73915649|NCT04523220|147360441|OTHER||Cox Proportional Hazard|1.24|||=|0.166|TWO_SIDED|90.0|0.96|1.61||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.61|0.96|= 0.166
74085889|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|6.833||0.819||95.0|-17.066|13.846|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours||13.846|-17.066|0.8190
73915650|NCT00256750|147360448|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.7|||||TWO_SIDED|97.3|-1.1|9.0||||||||9.0|-1.1|
73915651|NCT00256750|147360448|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|2.7|||||TWO_SIDED|97.3|-2.5|8.1|||||If the lower bound of the CI (belatacept-CsA) was \> -10%, then the corresponding belatacept regimen was considered non-inferior to CsA.|||8.1|-2.5|
73915652|NCT00256750|147360449|SUPERIORITY_OR_OTHER||Difference in Percent|-23.7|||<|0.0001|TWO_SIDED|97.3|-33.3|-13.7|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||||-13.7|-33.3|<.0001
73966028|NCT00567398|147468263|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
73915653|NCT00256750|147360449|SUPERIORITY_OR_OTHER||Difference in Percent|-22.9|||<|0.0001|TWO_SIDED|97.3|-32.6|-12.9|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||||-12.9|-32.6|<.0001
73915654|NCT00256750|147360450|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|10.0|||||TWO_SIDED|97.3|3.3|17.1|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||17.1|3.3|
73915655|NCT00256750|147360450|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens. The 20% non-inferiority margin was not met in the belatacept MI group.|Difference in Percent|14.7|||||TWO_SIDED|97.3|7.5|22.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||22.2|7.5|
73915656|NCT00256750|147360451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0|||<|0.0001|TWO_SIDED|97.3|7.3|18.7||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12||18.7|7.3|<0.0001
73915657|NCT00256750|147360451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|||<|0.0001|TWO_SIDED|97.3|8.9|20.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12||20.4|8.9|<0.0001
74085890|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-69.235|STANDARD_ERROR_OF_MEAN|390.483||0.8603||95.0|-861.171|722.7|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours||722.700|-861.171|0.8603
73915658|NCT00256750|147360451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.0001|TWO_SIDED|97.3|11.5|23.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24||23.4|11.5|<0.0001
73915659|NCT00256750|147360451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.5|||<|0.0001|TWO_SIDED|97.3|8.5|20.5||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24||20.5|8.5|<0.0001
73915660|NCT00256750|147360452|NON_INFERIORITY_OR_EQUIVALENCE|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-8.5||||0.0581|TWO_SIDED|97.3|-17.9|0.9|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.||||0.9|-17.9|0.0581
73915661|NCT00256750|147360452|NON_INFERIORITY_OR_EQUIVALENCE|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-14.2||||0.001|TWO_SIDED|97.3|-23.2|-5.0|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.||||-5.0|-23.2|0.0010
73915662|NCT00256750|147360457|SUPERIORITY_OR_OTHER||Difference in Percent|-8.5|||||TWO_SIDED|97.3|-14.6|-3.3|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine||-3.3|-14.6|
73915663|NCT00256750|147360457|SUPERIORITY_OR_OTHER||Difference in Percent|-10.3|||||TWO_SIDED|97.3|-16.1|-5.1|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine||-5.1|-16.1|
73915664|NCT00256750|147360461|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|15.3|||||TWO_SIDED|97.3|10.3|20.3|||||ANOVA model: GFR = treatment|Month 12||20.3|10.3|
73915665|NCT00256750|147360461|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|15.1|||||TWO_SIDED|97.3|10.1|20.1|||||ANOVA model: GFR = treatment|Month 12||20.1|10.1|
73915666|NCT00256750|147360461|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|17.5|||||TWO_SIDED|97.3|12.0|23.1|||||ANOVA model: GFR = treatment|Month 24||23.1|12.0|
73915667|NCT00256750|147360461|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|17.6|||||TWO_SIDED|97.3|12.0|23.3|||||ANOVA model: GFR = treatment|Month 24||23.3|12.0|
73915668|NCT00256750|147360461|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|21.4|||||TWO_SIDED|97.3|15.4|27.4|||||ANOVA model: GFR = treatment|Month 36||27.4|15.4|
74027204|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.71|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.53|0.71|
73915669|NCT00256750|147360461|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|20.8|||||TWO_SIDED|97.3|14.8|26.9|||||ANOVA model: GFR = treatment|Month 36||26.9|14.8|
74027205|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|7.3|||||TWO_SIDED|95.0|4.67|11.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||11.44|4.67|
73915670|NCT00256750|147360463|SUPERIORITY_OR_OTHER||Difference in Percent|-5.7||||0.0687|TWO_SIDED|97.3|-12.6|0.5||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12||0.5|-12.6|0.0687
73915671|NCT00256750|147360463|SUPERIORITY_OR_OTHER||Difference in Percent|-2.8||||0.4825|TWO_SIDED|97.3|-10.2|4.4||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12||4.4|-10.2|0.4825
73915672|NCT00256750|147360463|SUPERIORITY_OR_OTHER||Difference in Percent|-5.1||||0.1267|TWO_SIDED|97.3|-12.3|1.5||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24||1.5|-12.3|0.1267
73915673|NCT00256750|147360463|SUPERIORITY_OR_OTHER||Difference in Percent|-2.2||||0.6405|TWO_SIDED|97.3|-9.8|5.4||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24||5.4|-9.8|0.6405
73915674|NCT00256750|147360463|SUPERIORITY_OR_OTHER||Difference in Percent|-4.6||||0.2043|TWO_SIDED|97.3|-12.0|2.5|||Chi-squared|Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.||Month 36||2.5|-12.0|0.2043
73915675|NCT00256750|147360463|SUPERIORITY_OR_OTHER||Difference in Percent|-0.9||||0.9481|TWO_SIDED|97.3|-8.8|7.1||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 36||7.1|-8.8|0.9481
73915676|NCT00256750|147360464|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.0002|TWO_SIDED|97.3|0.31|0.74|||Chi-squared||Odds ratio is estimated by a cumulative logit model.|||0.74|0.31|0.0002
73915677|NCT00256750|147360464|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.6||||0.0092|TWO_SIDED|97.3|0.38|0.92|||Chi-squared||Odds ratio is estimated by a cumulative logit model.|||0.92|0.38|0.0092
73915678|NCT00256750|147360465|SUPERIORITY_OR_OTHER||Difference in Percent|-21.2|||||TWO_SIDED|97.3|-67.6|43.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||43.2|-67.6|
73915679|NCT00256750|147360465|SUPERIORITY_OR_OTHER||Difference in Percent|-17.9|||||TWO_SIDED|97.3|-72.3|52.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||52.2|-72.3|
73915680|NCT00256750|147360466|SUPERIORITY_OR_OTHER||Difference in Percent|-1.13|||||TWO_SIDED|97.3|-7.51|5.23|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||5.23|-7.51|
73915681|NCT00256750|147360466|SUPERIORITY_OR_OTHER||Difference in Percent|-2.37|||||TWO_SIDED|97.3|-9.01|4.15|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||4.15|-9.01|
73915682|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-7.3|||||TWO_SIDED|97.3|-11.4|-3.3||||||Systolic, Month 12||-3.3|-11.4|
73915683|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-6.0|||||TWO_SIDED|97.3|-10.1|-2.0||||||Systolic, Month 12||-2.0|-10.1|
73915684|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-3.2|||||TWO_SIDED|97.3|-5.8|-0.7||||||Diastolic, Month 12||-0.7|-5.8|
73915685|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.6|||||TWO_SIDED|97.3|-5.1|0.0||||||Diastolic, Month 12||0.0|-5.1|
73915686|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-4.9|||||TWO_SIDED|97.3|-9.2|-0.6||||||Systolic, Month 24||-0.6|-9.2|
73915687|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-5.5|||||TWO_SIDED|97.3|-9.9|-1.1||||||Systolic, Month 24||-1.1|-9.9|
73915688|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-1.9|||||TWO_SIDED|97.3|-4.4|0.5||||||Diastolic, Month 24||0.5|-4.4|
73915689|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.4|||||TWO_SIDED|97.3|-5.0|0.1||||||Diastolic, Month 24||0.1|-5.0|
73915690|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-5.8|||||TWO_SIDED|97.3|-10.0|-1.6||||||Systolic, Month 36||-1.6|-10.0|
73915691|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-7.5|||||TWO_SIDED|97.3|-11.7|-3.3||||||Systolic, Month 36||-3.3|-11.7|
73915692|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.9|||||TWO_SIDED|97.3|-5.4|-0.4||||||Diastolic, Month 36||-0.4|-5.4|
73915693|NCT00256750|147360467|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-3.4|||||TWO_SIDED|97.3|-6.0|-0.9||||||Diastolic, Month 36||-0.9|-6.0|
73915694|NCT00256750|147360468|SUPERIORITY_OR_OTHER||Difference in Percent|7.1|||||TWO_SIDED|97.3|-2.9|17.1|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12||17.1|-2.9|
73966029|NCT00567398|147468263|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
73915695|NCT00256750|147360468|SUPERIORITY_OR_OTHER||Difference in Percent|3.2|||||TWO_SIDED|97.3|-6.6|12.9|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12||12.9|-6.6|
73915696|NCT00256750|147360469|SUPERIORITY_OR_OTHER||Difference in Percent|7.01|||||TWO_SIDED|97.3|-2.79|16.71|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||16.71|-2.79|
73915697|NCT00256750|147360469|SUPERIORITY_OR_OTHER||Difference in Percent|3.77|||||TWO_SIDED|97.3|-5.86|13.35|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||13.35|-5.86|
73915698|NCT00256750|147360474|SUPERIORITY_OR_OTHER||Difference in Percent|-10.4|||||TWO_SIDED|97.3|-21.4|1.0||||||||1.0|-21.4|
73915699|NCT00256750|147360474|SUPERIORITY_OR_OTHER||Difference in Percent|-8.7|||||TWO_SIDED|97.3|-19.9|2.7||||||||2.7|-19.9|
73966030|NCT00567398|147468263|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
73966031|NCT00567398|147468263|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
73966032|NCT00567398|147468264|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
73966033|NCT00567398|147468264|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
73915700|NCT00256750|147360476|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|11.4|||||TWO_SIDED|97.3|5.0|18.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 6||18.2|5.0|
73915701|NCT00256750|147360476|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|16.5|||||TWO_SIDED|97.3|9.6|23.8|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 6||23.8|9.6|
73915702|NCT00256750|147360476|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|8.2|||||TWO_SIDED|97.3|1.2|15.4|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used|Month 24||15.4|1.2|
73915703|NCT00256750|147360476|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|15.2|||||TWO_SIDED|97.3|7.5|23.0|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 24||23.0|7.5|
74027206|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|2.6|||||TWO_SIDED|95.0|1.61|4.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||4.17|1.61|
73915704|NCT00256750|147360476|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|7.8|||||TWO_SIDED|97.3|0.6|15.0|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 36||15.0|0.6|
73915705|NCT00256750|147360476|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|14.7|||||TWO_SIDED|97.3|7.0|22.6|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 36||22.6|7.0|
73915706|NCT00256750|147360478|SUPERIORITY_OR_OTHER||Difference in Percent|-3.2|||||TWO_SIDED|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||-0.6|-6.6|
73966034|NCT00567398|147468264|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
73966035|NCT00567398|147468264|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
74027207|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|2.0|||||TWO_SIDED|95.0|1.22|3.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||3.29|1.22|
74027208|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|0.96|2.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.77|0.96|
73966036|NCT00567398|147468265|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
73966037|NCT00567398|147468265|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
73966038|NCT00567398|147468266|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
73966039|NCT00567398|147468266|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
73966040|NCT00567398|147468267|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
73966041|NCT00567398|147468267|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
74027209|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.28|0.54|
74027210|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.92|2.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.07|0.92|
74027211|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|1.01|1.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.83|1.01|
74027212|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|1.2|||||TWO_SIDED|95.0|0.77|1.78|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.78|0.77|
74027213|NCT01025336|147607537|SUPERIORITY_OR_OTHER||Ratio|3.0|||||TWO_SIDED|95.0|1.97|4.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||4.64|1.97|
74027214|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.15|2.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.15|1.15|
74027215|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.76|1.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.32|0.76|
74027216|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.09|3.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||3.05|1.09|
74027217|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.95|1.96|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.96|0.95|
74027218|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|4.8|||||TWO_SIDED|95.0|3.05|7.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||7.50|3.05|
74027219|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|2.3|||||TWO_SIDED|95.0|1.4|3.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||3.64|1.40|
74027220|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.58|1.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.62|0.58|
74085891|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.395|STANDARD_ERROR_OF_MEAN|384.376||0.9642||95.0|-796.945|762.155|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours||762.155|-796.945|0.9642
74085892|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|93.693|STANDARD_ERROR_OF_MEAN|484.957||0.8476||95.0|-880.865|1068.251|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours||1068.251|-880.865|0.8476
73859939|NCT01340937|147265923|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|3.28|||<|0.001|TWO_SIDED|95.0|-1.7|8.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||8.85|-1.70|<0.001
74027221|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.83|2.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.32|0.83|
74027222|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|0.9|||||TWO_SIDED|95.0|0.58|1.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.40|0.58|
74027223|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.09|2.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.41|1.09|
74027224|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|1.5|||||TWO_SIDED|95.0|1.1|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.03|1.10|
74027225|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|1.3|||||TWO_SIDED|95.0|0.89|2.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.02|0.89|
73859940|NCT01340937|147265924|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-4.12|||||TWO_SIDED|95.0|-7.69|-0.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||-0.63|-7.69|
73915707|NCT00256750|147360478|SUPERIORITY_OR_OTHER||Difference in Percent|-3.2|||||TWO_SIDED|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||-0.6|-6.6|
73915708|NCT00256750|147360482|SUPERIORITY_OR_OTHER||Difference in Percent|-0.5|||||TWO_SIDED|97.3|-6.5|5.3||||||Month 12||5.3|-6.5|
73915709|NCT00256750|147360482|SUPERIORITY_OR_OTHER||Difference in Percent|-0.9|||||TWO_SIDED|97.3|-6.9|4.8||||||||4.8|-6.9|
73915710|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6573|TWO_SIDED|95.0|-1.6|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||2.6|-1.6|0.6573
73915711|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.1198|TWO_SIDED|95.0|-0.4|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||3.9|-0.4|0.1198
73915712|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.0672|TWO_SIDED|95.0|-0.1|3.2||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.2|-0.1|0.0672
73915713|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0257|TWO_SIDED|95.0|0.2|3.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.6|0.2|0.0257
73915714|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4146|TWO_SIDED|95.0|-1.2|2.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.9|-1.2|0.4146
73915715|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.7327|TWO_SIDED|95.0|-1.7|2.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.4|-1.7|0.7327
73915716|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0144|TWO_SIDED|95.0|0.4|3.8||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.8|0.4|0.0144
73915717|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.8||||0.0015|TWO_SIDED|95.0|1.1|4.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||4.5|1.1|0.0015
73915718|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.234|TWO_SIDED|95.0|-0.8|3.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||3.4|-0.8|0.2340
73915719|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6635|TWO_SIDED|95.0|-1.7|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||2.6|-1.7|0.6635
73966042|NCT00567398|147468268|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
73966043|NCT00567398|147468269|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
73966044|NCT00567398|147468269|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
73966045|NCT00567398|147468269|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
73966046|NCT00567398|147468269|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
73966047|NCT00567398|147468270|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
73966048|NCT00567398|147468270|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
73859941|NCT01340937|147265924|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-4.17|||||TWO_SIDED|95.0|-7.75|-0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||-0.66|-7.75|
73859942|NCT01340937|147265924|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.07|||||TWO_SIDED|95.0|-3.32|3.2|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||3.20|-3.32|
73859943|NCT01340937|147265924|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|2.85|||<|0.001|TWO_SIDED|95.0|-0.85|7.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||7.36|-0.85|<0.001
73859944|NCT01340937|147265925|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
73859945|NCT01340937|147265925|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
73859946|NCT01340937|147265925|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
73859947|NCT01340937|147265925|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.66|||<|0.001|TWO_SIDED|95.0|0.18|2.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.36|0.18|<0.001
73859948|NCT01340937|147265926|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
73859949|NCT01340937|147265926|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.60|-0.61|
73859950|NCT01340937|147265926|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.60|-0.61|
73859951|NCT01340937|147265926|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.0|||<|0.001|TWO_SIDED|95.0|-0.2|1.24|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.24|-0.20|<0.001
73859952|NCT01340937|147265927|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
73859953|NCT01340937|147265927|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
73859954|NCT01340937|147265927|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
73859955|NCT01340937|147265927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.33|||<|0.001|TWO_SIDED|95.0|0.05|1.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.85|0.05|<0.001
73966049|NCT00567398|147468271|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
73966050|NCT00567398|147468271|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
73966051|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
73966052|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
73966053|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
73966054|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
73915720|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.8||||0.0417|TWO_SIDED|95.0|0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.5|0.1|0.0417
73915721|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.7||||0.0026|TWO_SIDED|95.0|0.9|4.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||4.4|0.9|0.0026
73915722|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0953|TWO_SIDED|95.0|-0.3|4.1||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.1|-0.3|0.0953
73915723|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1961|TWO_SIDED|95.0|-0.8|3.7||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||3.7|-0.8|0.1961
73915724|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0191|TWO_SIDED|95.0|0.3|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.9|0.3|0.0191
73915725|NCT00256750|147360484|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0684|TWO_SIDED|95.0|-0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.5|-0.1|0.0684
73915726|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0714|TWO_SIDED|95.0|-0.2|3.9|||ANOVA|Domain Score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6||3.9|-0.2|0.0714
74085893|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|105.543|STANDARD_ERROR_OF_MEAN|457.374||0.8185||95.0|-813.584|1024.67|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours||1024.670|-813.584|0.8185
74085894|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-682.304|STANDARD_ERROR_OF_MEAN|495.241||0.1792||95.0|-1696.759|332.15|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours||332.150|-1696.759|0.1792
73915727|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0536|TWO_SIDED|95.0|0.0|4.1|||ANOVA|Domain score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6||4.1|-0.0|0.0536
73915728|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.3||||0.7543|TWO_SIDED|95.0|-1.6|2.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6||2.2|-1.6|0.7543
73915729|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.1||||0.2499|TWO_SIDED|95.0|-0.8|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6||3.0|-0.8|0.2499
73915730|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.2||||0.8332|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6||2.3|-1.9|0.8332
73915731|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2523|TWO_SIDED|95.0|-0.9|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6||3.4|-0.9|0.2523
73915732|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.9||||0.3018|TWO_SIDED|95.0|-0.8|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6||2.7|-0.8|0.3018
74085895|NCT00442546|147725960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-250.439|STANDARD_ERROR_OF_MEAN|501.808||0.6216||95.0|-1278.347|777.469|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours||777.469|-1278.347|0.6216
74085896|NCT00442546|147725961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-494.0|STANDARD_ERROR_OF_MEAN|301.253||0.1996||95.0|-1452.72|464.72|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.||464.720|-1452.720|0.1996
74085897|NCT00442546|147725961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-195.15|STANDARD_ERROR_OF_MEAN|368.958||0.6335||95.0|-1369.338|979.038|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.||979.038|-1369.338|0.6335
73915733|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.6||||0.5437|TWO_SIDED|95.0|-1.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6||2.3|-1.2|0.5437
73915734|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.237|TWO_SIDED|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6||3.6|-0.9|0.2370
73915735|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0588|TWO_SIDED|95.0|-0.1|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6||4.5|-0.1|0.0588
73915736|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0502|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Physical, Month 6||4.0|-0.0|0.0502
73915737|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|3.6||||0.0007|TWO_SIDED|95.0|1.5|5.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 6||5.6|1.5|0.0007
73915738|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.3||||0.7637|TWO_SIDED|95.0|-1.8|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6||2.4|-1.8|0.7637
73915739|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.7006|TWO_SIDED|95.0|-1.7|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6||2.5|-1.7|0.7006
73915740|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1222|TWO_SIDED|95.0|-0.4|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6||3.4|-0.4|0.1222
73915741|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0289|TWO_SIDED|95.0|0.2|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6||4.1|0.2|0.0289
73966055|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
74027226|NCT01025336|147607538|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.27|2.97|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.97|1.27|
74085898|NCT00442546|147725961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.291|STANDARD_ERROR_OF_MEAN|302.355||0.929||95.0|-657.992|603.41|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2||603.410|-657.992|0.9290
73915742|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0571|TWO_SIDED|95.0|-0.1|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12||3.8|-0.1|0.0571
73915743|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.9||||0.0042|TWO_SIDED|95.0|0.9|4.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12||4.9|0.9|0.0042
73915744|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0423|TWO_SIDED|95.0|0.1|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12||3.7|0.1|0.0423
73915745|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0174|TWO_SIDED|95.0|0.4|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12||4.1|0.4|0.0174
73915746|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.363|TWO_SIDED|95.0|-1.1|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 12||3.0|-1.1|0.3630
74027227|NCT00847613|147607547|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|36.48|||<|0.0001|TWO_SIDED|95.0|27.73|45.23||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||45.23|27.73|<0.0001
74027228|NCT00847613|147607547|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|26.13|||<|0.0001|TWO_SIDED|95.0|17.28|34.97||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||34.97|17.28|<0.0001
73915747|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6319|TWO_SIDED|95.0|-1.6|2.6|||ANOVA|Missing data were imputed by LOCF|Missing data were imputed by LOCF|Mental Health, Month 12||2.6|-1.6|0.6319
73915748|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.8||||0.0503|TWO_SIDED|95.0|0.0|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12||3.7|-0.0|0.0503
73915749|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.9||||0.3291|TWO_SIDED|95.0|-0.9|2.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12||2.8|-0.9|0.3291
73915750|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.386|TWO_SIDED|95.0|-1.2|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12||3.1|-1.2|0.3860
73915751|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.0||||0.9672|TWO_SIDED|95.0|-2.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12||2.3|-2.2|0.9672
73915752|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0392|TWO_SIDED|95.0|0.1|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12||4.1|0.1|0.0392
73915753|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0151|TWO_SIDED|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12||4.5|0.5|0.0151
73915754|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.3978|TWO_SIDED|95.0|-1.1|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12||2.7|-1.1|0.3978
73915755|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1263|TWO_SIDED|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12||3.5|-0.4|0.1263
73915756|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.016|TWO_SIDED|95.0|0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12||4.2|0.4|0.0160
73966056|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
73966057|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
73966058|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
73966059|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
73966060|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
73966061|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
73859956|NCT01340937|147265928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.07|||<|0.001|TWO_SIDED|95.0|0.98|1.17|||Analysis of Covariance|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.17|0.98|<0.001
73859957|NCT01340937|147265929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.95|0.79|<0.001
73859958|NCT01340937|147265930|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.74||||0.035|TWO_SIDED|95.0|0.66|0.83|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.83|0.66|0.035
73859959|NCT01340937|147265931|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.31|||<|0.001|TWO_SIDED|95.0|1.17|1.46|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.46|1.17|<0.001
73859960|NCT01340937|147265932|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.12|||<|0.001|TWO_SIDED|95.0|-1.11|2.58|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.58|-1.11|<0.001
73859961|NCT01340937|147265933|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-0.16|||<|0.001|TWO_SIDED|95.0|-2.41|3.22|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.22|-2.41|<0.001
73859962|NCT01340937|147265934|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|1.15|||<|0.001|TWO_SIDED|95.0|-2.13|5.47|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||5.47|-2.13|<0.001
73859963|NCT01340937|147265935|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|3.0|||<|0.001|TWO_SIDED|95.0|-0.39|7.4|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||7.40|-0.39|<0.001
73859964|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.92|||<|0.001|TWO_SIDED|95.0|0.82|1.04|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 1||1.04|0.82|<0.001
73859965|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 3||1.06|0.84|<0.001
73859966|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.89|1.12|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 4||1.12|0.89|<0.001
73915757|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.6||||0.0075|TWO_SIDED|95.0|0.7|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12||4.5|0.7|0.0075
73915758|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.699|TWO_SIDED|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24||2.4|-1.6|0.6990
73915759|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1608|TWO_SIDED|95.0|-0.6|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24||3.5|-0.6|0.1608
73915760|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0214|TWO_SIDED|95.0|0.3|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24||4.0|0.3|0.0214
73915761|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.00886|TWO_SIDED|95.0|0.6|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24||4.4|0.6|0.00886
73915762|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.2||||0.2555|TWO_SIDED|95.0|-0.9|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24||3.3|-0.9|0.2555
73915763|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4804|TWO_SIDED|95.0|-1.4|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24||2.9|-1.4|0.4804
73915764|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0276|TWO_SIDED|95.0|0.2|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24||4.2|0.2|0.0276
73966062|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
73915765|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1285|TWO_SIDED|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24||3.5|-0.4|0.1285
73915766|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.1352|TWO_SIDED|95.0|-0.5|3.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24||3.9|-0.5|0.1352
73966063|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
73966064|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
73966065|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
73966066|NCT00567398|147468272|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
73966067|NCT00567398|147468273|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
73966068|NCT00567398|147468273|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
74085899|NCT00442546|147725961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.787|STANDARD_ERROR_OF_MEAN|256.969||0.8937||95.0|-501.241|570.815|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2||570.815|-501.241|0.8937
74085900|NCT00442546|147725961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|198.937|STANDARD_ERROR_OF_MEAN|491.153||0.6912||95.0|-847.93|1245.804|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4||1245.804|-847.930|0.6912
73915767|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2663|TWO_SIDED|95.0|-1.0|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24||3.5|-1.0|0.2663
73915768|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0164|TWO_SIDED|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24||4.5|0.5|0.0164
73915769|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|3.9||||0.0002|TWO_SIDED|95.0|1.9|5.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24||5.9|1.9|0.0002
73966069|NCT00567398|147468274|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
73966070|NCT00567398|147468274|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
73966071|NCT00567398|147468275|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
73966072|NCT00567398|147468275|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
73966073|NCT00567398|147468276|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
73966074|NCT03517553|147468277|SUPERIORITY|||||||0.999||||||Threshold for statistical significance is P\<0.05|Kruskal-Wallis|||||||0.999
73966075|NCT03517553|147468277|SUPERIORITY|||||||0.768|||||||Kruskal-Wallis|||||||0.768
73966076|NCT03517553|147468278|SUPERIORITY|||||||0.869|||||||Kruskal-Wallis|||||||0.869
73966077|NCT03517553|147468278|SUPERIORITY|||||||0.813|||||||Kruskal-Wallis|||||||0.813
73966078|NCT03517553|147468278|SUPERIORITY|||||||0.978|||||||Kruskal-Wallis|||||||0.978
73966079|NCT03517553|147468278|SUPERIORITY|||||||0.731|||||||Kruskal-Wallis|||||||0.731
73966080|NCT03517553|147468278|SUPERIORITY|||||||0.703|||||||Kruskal-Wallis|||||||0.703
73966081|NCT03517553|147468278|SUPERIORITY|||||||0.909|||||||Kruskal-Wallis|||||||0.909
73966082|NCT02201108|147468295|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.2949|TWO_SIDED|95.0|0.388|1.113||Threshold for significance was \< 0.05.|Stratified Log-Rank test|P-value derived from log-rank test with stratification of region and pubertal status.|Hazard ratio was estimated using a Cox proportional-hazards model with factors for treatment group, region, pubertal status, age, and number of relapses in the year prior to randomization as covariates and with robust variance estimation.|||1.113|0.388|0.2949
73966083|NCT02201108|147468297|OTHER||Relative risk ratio|0.511|||||TWO_SIDED|95.0|0.343|0.762||||||||0.762|0.343|
73966084|NCT02201108|147468298|OTHER||Relative risk ratio|0.57|||||TWO_SIDED|95.0|0.331|0.983||||||||0.983|0.331|
73966085|NCT02201108|147468301|OTHER||Relative risk ratio|0.498|||||TWO_SIDED|95.0|0.296|0.836||||||||0.836|0.296|
73966086|NCT02201108|147468315|OTHER||Hazard Ratio (HR)|0.693|||||TWO_SIDED|95.0|0.37|1.296|||||Hazard ratio estimated using a Cox proportional-hazards model using treatment group, region, pubertal status, age, and number of relapses in the year prior to randomisation as covariates and with robust variance estimation.|||1.296|0.37|
73966087|NCT03830177|147468325|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73966088|NCT03830177|147468326|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73966089|NCT03830177|147468327|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73966090|NCT03830177|147468328|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73966091|NCT03830177|147468330|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73966092|NCT05145257|147468338|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966093|NCT05145257|147468339|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966094|NCT05145257|147468340|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73859967|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.93|||<|0.001|TWO_SIDED|95.0|0.8|1.07|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 5||1.07|0.80|<0.001
73859968|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.87|||<|0.001|TWO_SIDED|95.0|0.77|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6A||0.99|0.77|<0.001
73859969|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.79||||0.055|TWO_SIDED|95.0|0.64|0.96|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6B||0.96|0.64|0.055
73859970|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 7F||0.99|0.80|<0.001
73859971|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.88|1.13|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 9V||1.13|0.88|<0.001
73859972|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|TWO_SIDED|95.0|0.82|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 14||1.10|0.82|<0.001
73859973|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.0|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 18C||1.00|0.79|<0.001
73859974|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.91|||<|0.001|TWO_SIDED|95.0|0.8|1.03|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19A||1.03|0.80|<0.001
73859975|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.08|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19F||1.08|0.87|<0.001
73859976|NCT01340937|147265936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.9|||<|0.001|TWO_SIDED|95.0|0.77|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 23F||1.06|0.77|<0.001
73859977|NCT01340937|147265938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||||TWO_SIDED|95.0|-18.8|-8.4|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \<38.0°C||-8.4|-18.8|
73859978|NCT01340937|147265938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||||TWO_SIDED|95.0|-0.9|8.3|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=38°C and \<38.5°||8.3|-0.9|
73859979|NCT01340937|147265938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|4.8|11.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=38.5°C and \<39.5°||11.9|4.8|
73915770|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1914|TWO_SIDED|95.0|-0.7|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24||3.3|-0.7|0.1914
73915771|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.6882|TWO_SIDED|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24||2.4|-1.6|0.6882
73915772|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0547|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24||4.0|-0.0|0.0547
73915773|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0992|TWO_SIDED|95.0|-0.3|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24||3.8|-0.3|0.0992
73915774|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0339|TWO_SIDED|95.0|0.2|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36||4.4|0.2|0.0339
73915775|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.3572|TWO_SIDED|95.0|-1.1|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36||3.1|-1.1|0.3572
73915776|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0211|TWO_SIDED|95.0|0.3|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36||4.2|0.3|0.0211
73915777|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.045|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36||4.0|0.0|0.0450
73915778|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.171|TWO_SIDED|95.0|-0.7|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36||3.7|-0.7|0.1710
73915779|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2484|TWO_SIDED|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36||3.6|-0.9|0.2484
73966095|NCT05145257|147468341|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
74027229|NCT00847613|147607548|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0376|TWO_SIDED|95.0|-0.79|-0.02||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.||-0.02|-0.79|0.0376
74027230|NCT00847613|147607548|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.0792|TWO_SIDED|95.0|-0.73|0.04||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.||0.04|-0.73|0.0792
73859980|NCT01340937|147265938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.7|2.2|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=39.5°C||2.2|-0.7|
73859981|NCT01340937|147265938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||||TWO_SIDED|95.0|-16.6|-5.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal \<38.0°C||-5.9|-16.6|
73859982|NCT01340937|147265938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-1.4|7.8|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal \>=38.0°C and \<38.5°C||7.8|-1.4|
73859983|NCT01340937|147265938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|||||TWO_SIDED|95.0|4.6|11.6|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal \>=38.5°C and \<39.5°C||11.6|4.6|
73859984|NCT01340937|147265938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.7|2.1|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal \>=39.5°C||2.1|-0.7|
73859985|NCT02685748|147265960|OTHER||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.444||0.863|TWO_SIDED|95.0|-0.969|0.815|||t-test, 2 sided|||||0.815|-0.969|0.863
73859986|NCT02685748|147265961|OTHER|T test for independent samples|Mean Difference (Final Values)|3.616|STANDARD_ERROR_OF_MEAN|2.364||0.133|TWO_SIDED|95.0|-1.147|8.379|||t-test, 2 sided|||||8.379|-1.147|0.133
73859987|NCT02685748|147265962|OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.43||1.607|TWO_SIDED|95.0|-1.1553|0.172|||t-test, 2 sided|||||0.172|-1.1553|1.607
73859988|NCT02685748|147265963|OTHER||Mean Difference (Final Values)|-1.282|STANDARD_ERROR_OF_MEAN|1.754||0.468|TWO_SIDED|95.0|-4.807|2.241|||t-test, 2 sided|||||2.241|-4.807|0.468
73859989|NCT02685748|147265964|OTHER||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.406||0.899|TWO_SIDED|95.0|-0.869|0.765|||t-test, 2 sided|||||0.765|-0.869|0.899
73859990|NCT02685748|147265965|OTHER||Mean Difference (Final Values)|7.05|STANDARD_DEVIATION|6.797||0.305|TWO_SIDED|95.0|-6.602|20.703|||t-test, 2 sided|||||20.703|-6.602|0.305
73859991|NCT02685748|147265966|OTHER||Mean Difference (Final Values)|160.298|STANDARD_ERROR_OF_MEAN|159.525||0.32|TWO_SIDED|95.0|-160.118|480.714|||t-test, 2 sided|||||480.714|-160.118|0.320
73859992|NCT02685748|147265967|OTHER||Mean Difference (Final Values)|-1.495|STANDARD_ERROR_OF_MEAN|3.558||0.676|TWO_SIDED|95.0|-8.642|5.651|||t-test, 2 sided|||||5.651|-8.642|0.676
73859993|NCT03500172|147265974|SUPERIORITY|||||||0.455||||||Threshold for significance: 0.05|Two sample test of proportions|||||||0.455
73859994|NCT03500172|147265975|SUPERIORITY|||||||0.962||||||Statistical significance threshold: 0.05|Two sample test of proportions|||||||0.962
73859995|NCT03500172|147265976|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.05|TWO_SIDED|95.0|0.61|0.99||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for steady partner, living together vs. single.||0.99|0.61|<0.05
73859996|NCT03500172|147265976|SUPERIORITY||Hazard Ratio (HR)|1.6|||<|0.05|TWO_SIDED|95.0|1.02|2.51||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for 5-9 new clients in the past month vs. 0 clients in the past month.||2.51|1.02|<0.05
73859997|NCT03500172|147265976|SUPERIORITY||Hazard Ratio (HR)|1.31|||<|0.05|TWO_SIDED|95.0|1.09|1.57||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for use of marijuana in the past 30 days vs. no marijuana use in the past 30 days||1.57|1.09|<0.05
73859998|NCT03500172|147265976|SUPERIORITY||Hazard Ratio (HR)|1.24|||<|0.05|TWO_SIDED|95.0|1.01|1.52||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those experiencing physical violence in the past 6 months vs. no experience of physical violence in the past 6 months.||1.52|1.01|<0.05
73859999|NCT03500172|147265976|SUPERIORITY||Hazard Ratio (HR)|1.62|||<|0.05|TWO_SIDED|95.0|1.31|2.0||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those who have experienced sexual violence in the past 6 months vs. those who have not||2.00|1.31|<0.05
73860000|NCT03500172|147265976|SUPERIORITY||Hazard Ratio (HR)|2.33|||<|0.05|TWO_SIDED|95.0|1.65|3.29||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those with viral loads from 50-1000 copies/mL at baseline vs. \<50 copies/mL.||3.29|1.65|<0.05
73966096|NCT05145257|147468342|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966097|NCT05145257|147468343|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966098|NCT05145257|147468344|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966099|NCT05145257|147468345|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966100|NCT05145257|147468346|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966101|NCT05145257|147468347|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966102|NCT05145257|147468348|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966103|NCT05145257|147468349|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
74085901|NCT00442546|147725961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|185.728|STANDARD_ERROR_OF_MEAN|349.047||0.6024||95.0|-558.248|929.704|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4||929.704|-558.248|0.6024
73860001|NCT03500172|147265976|SUPERIORITY||Hazard Ratio (HR)|2.47|||<|0.05|TWO_SIDED|95.0|1.82|3.36||Threshold for significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those with viral load greater than 1000 copies/mL vs. those with viral load less than 50 copies/mL.||3.36|1.82|<0.05
73860002|NCT03500172|147265977|SUPERIORITY|||||||0.756||||||Threshold of significance: 0.05|Two sample test of proportions|||||||0.756
73860003|NCT03500172|147265978|SUPERIORITY|||||||0.295||||||Threshold of statistical significance: 0.05|Two sample test of proportions|||||||0.295
73860004|NCT03500172|147265979|SUPERIORITY|||||||0.149||||||Threshold for statistical significance: 0.05|Two sample test of proportions|||||||0.149
73860005|NCT03500172|147265980|SUPERIORITY|||||||0.301||||||Threshold of significance: 0.05|Two sample test of proportions|||||||0.301
73860006|NCT03500172|147265983|SUPERIORITY|||||||0.212||||||Threshold of statistical significance: 0.05|Chi-squared|||||||0.212
73860007|NCT01035346|147265988|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|8.33||||0.228|TWO_SIDED|95.0|-7.94|24.6||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95 percent (%) confidence interval (CI) were calculated based on Least-squares (LS) means from the Analysis of Variance (ANOVA) model.||24.60|-7.94|0.228
73860008|NCT01035346|147265989|SUPERIORITY_OR_OTHER||LS mean difference|5.99||||0.171|TWO_SIDED|95.0|-3.99|15.97||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-4: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||15.97|-3.99|0.171
73860009|NCT01035346|147265989|SUPERIORITY_OR_OTHER||LS mean difference|8.96||||0.354|TWO_SIDED|95.0|-14.78|32.69||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-8: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||32.69|-14.78|0.354
73860010|NCT01035346|147265990|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.576|TWO_SIDED|95.0|-0.84|0.54||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.54|-0.84|0.576
73860011|NCT01035346|147265990|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.502|TWO_SIDED|95.0|-0.5|0.87||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.87|-0.50|0.502
73860012|NCT01035346|147265990|SUPERIORITY_OR_OTHER||LS mean difference|1.31||||0.116|TWO_SIDED|95.0|-0.51|3.12||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.12|-0.51|0.116
73860013|NCT01035346|147265990|SUPERIORITY_OR_OTHER||LS mean difference|1.58||||0.161|TWO_SIDED|95.0|-0.98|4.14||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.14|-0.98|0.161
73860014|NCT01035346|147265990|SUPERIORITY_OR_OTHER||LS mean difference|1.87||||0.215|TWO_SIDED|95.0|-1.66|5.41||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.41|-1.66|0.215
73860015|NCT01035346|147265990|SUPERIORITY_OR_OTHER||LS mean difference|1.17||||0.388|TWO_SIDED|95.0|-2.18|4.52||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.52|-2.18|0.388
73860016|NCT01035346|147265990|SUPERIORITY_OR_OTHER||LS mean difference|0.31||||0.849|TWO_SIDED|95.0|-3.98|4.61||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.61|-3.98|0.849
73860017|NCT01035346|147265992|SUPERIORITY_OR_OTHER||difference in proportion|11.11||||0.378|TWO_SIDED|95.0|-10.67|32.89||p-value was calculated using CMH general association test using table scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and its associated CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportion and the corresponding standard errors.||32.89|-10.67|0.378
73915780|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1836|TWO_SIDED|95.0|-0.6|3.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36||3.2|-0.6|0.1836
73915781|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.3303|TWO_SIDED|95.0|-1.0|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36||2.9|-1.0|0.3303
73915782|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0299|TWO_SIDED|95.0|0.2|4.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36||4.8|0.2|0.0299
73915783|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.1141|TWO_SIDED|95.0|-0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36||4.2|-0.4|0.1141
73915784|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.7||||0.0087|TWO_SIDED|95.0|0.7|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36||4.7|0.7|0.0087
73860018|NCT01035346|147265993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.324|TWO_SIDED|95.0|-0.3|1.27||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||1.27|-0.30|0.324
73966104|NCT05145257|147468350|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966105|NCT05145257|147468351|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966106|NCT05145257|147468352|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966107|NCT05145257|147468353|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
73966108|NCT05485922|147468357|SUPERIORITY|Number of flow-stop episodes will be analysed, in a generalized linier mixed model, with subject included as a random component. Evidence of superior effect will be concluded, if the lower 95% confidence limit of the risk ratio between comparator and investigational device, is more than 1.|Risk Ratio (RR)|0.16|||<|0.05|TWO_SIDED|95.0|0.05|0.44|||Mixed Models Analysis|||||0.44|0.05|<0.05
73966109|NCT05485922|147468358|SUPERIORITY||Mean Difference (Final Values)|34.3||||0.05|TWO_SIDED|95.0|14.69|53.91||The pass criteria were based on results analysing the 2 primary endpoints in a hierarchical fashion: rejecting the H0 on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||53.91|14.69|0.05
73966110|NCT05485922|147468359|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.16||||0.05|TWO_SIDED|95.0|0.05|0.44|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.44|0.05|0.05
73966111|NCT05485922|147468360|SUPERIORITY||Mean Difference (Final Values)|-95.69||||0.05|TWO_SIDED|95.0|-137.69|-53.7|||Mixed Models Analysis|||The intra-catheter pressure at flow stop was analysed in a general linear mixed model with subject included as a random component.||-53.70|-137.69|0.05
74027231|NCT00847613|147607549|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.49|-0.31||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in mTSS had to be significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% confidence interval (CI) was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.31|-0.49|<0.0001
74027232|NCT00847613|147607549|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.05||0.0002|TWO_SIDED|95.0|-0.34|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in mTSS had to be statistically significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.16|-0.34|0.0002
74027233|NCT00847613|147607550|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|14.4|||<|0.0001|TWO_SIDED|95.0|9.44|19.36||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||19.36|9.44|<0.0001
74027234|NCT00847613|147607550|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|5.61||||0.0034|TWO_SIDED|95.0|1.85|9.38||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||9.38|1.85|0.0034
74085902|NCT00442546|147725961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-256.921|STANDARD_ERROR_OF_MEAN|407.391||0.5372||95.0|-1120.551|606.709|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET||606.709|-1120.551|0.5372
74085903|NCT00442546|147725961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-287.032|STANDARD_ERROR_OF_MEAN|328.227||0.3948||95.0|-982.843|408.778|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET||408.778|-982.843|0.3948
74085904|NCT00442546|147725962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-121.5|STANDARD_ERROR_OF_MEAN|1169.654||0.9341|TWO_SIDED|95.0|-14983.36|14740.362|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|||14740.362|-14983.36|0.9341
73966112|NCT05485922|147468361|OTHER||Mean Difference (Final Values)|1.21||||0.05|TWO_SIDED|95.0|-11.1|13.51|||Mixed Models Analysis|||||13.51|-11.10|0.05
73966113|NCT05485922|147468362|SUPERIORITY||Odds Ratio (OR)|0.26||||0.05|TWO_SIDED|95.0|0.07|0.96|||Mixed Models Analysis|||Analyzed using a generalized linear mixed model, modelling the probability of a positive outcome. Evidence of effect in favour of the MHZC was concluded if the upper 95% confidence limit (CL) of the odds ratio, O.R. was less than 1.||0.96|0.07|0.05
73966114|NCT00894543|147468404|SUPERIORITY_OR_OTHER||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.||||<0.001
74027235|NCT03368404|147607642|NON_INFERIORITY|A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-102 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.34|0.13|||||Treatment difference : CBL-102 - Vismed Multi|||0.13|-1.34|
74027236|NCT03368404|147607643|SUPERIORITY|||||||0.0592||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0592
74027237|NCT03368404|147607644|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
74085905|NCT00442546|147725964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|302.9|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|302.9|302.9|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|||302.900|302.900|<0.0001
74085906|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.087||0.1661||95.0|-0.293|0.051|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.051|-0.293|0.1661
73860019|NCT01035346|147265994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.21|TWO_SIDED|95.0|-0.12|1.18||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||1.18|-0.12|0.210
74027238|NCT03368404|147607645|SUPERIORITY||||||>|0.05||||||Significance level 0.05|ANCOVA|Adjustment for baseline||||||>0.05
74027239|NCT03368404|147607646|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
74027240|NCT03368404|147607647|SUPERIORITY|||||||0.0176||||||Significance level 0.05|ANCOVA|||Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4)||||0.0176
74085907|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.088||0.3604||95.0|-0.254|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.093|-0.254|0.3604
74085908|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.083||0.1299||95.0|-0.29|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.037|-0.290|0.1299
73860020|NCT01974752|147265995|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.3195|TWO_SIDED|95.0|0.48|1.27|||Log Rank|Factor for treatment and liver metastases|A hazard ratio \< 1 favours Selumetinib in combination with Dacarbazine|||1.27|0.48|0.3195
74027241|NCT03368404|147607647|SUPERIORITY|||||||0.001||||||Significance level 0.05|ANCOVA|Adjustment to baseline||Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)||||0.0010
74027242|NCT03368404|147607648|SUPERIORITY|||||||0.0251||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:~Daily Activities"||||0.0251
74085909|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.129|STANDARD_ERROR_OF_MEAN|0.082||0.1167||95.0|-0.29|0.032|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.032|-0.290|0.1167
74085910|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.09||0.5271||95.0|-0.234|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.120|-0.234|0.5271
73860021|NCT01974752|147265997|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.94||||0.1284|TWO_SIDED|95.0|0.88|1.02|||ANCOVA|ANCOVA of log (W6/BL) tumour assessments with a factor for trt, and covariates for liver mets, log BL tumour size, and time from BL scan to rand.|A geometric least squares mean ratio \< 1 favours Selumetinib in combination with Dacarbazine|||1.02|0.88|0.1284
73860022|NCT01974752|147265998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.4011|TWO_SIDED|95.0|0.39|1.46|||Log Rank|||||1.46|0.39|0.4011
73860023|NCT05074888|147266032|SUPERIORITY|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.0016
73860024|NCT05074888|147266033|SUPERIORITY|||||||0.3183|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.3183
73860025|NCT05074888|147266034|SUPERIORITY|||||||0.5805|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.5805
73860026|NCT05074888|147266035|SUPERIORITY|||||||0.2143|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.2143
73860027|NCT05074888|147266036|SUPERIORITY|||||||0.8156|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.8156
73860028|NCT05074888|147266037|SUPERIORITY|||||||0.1049|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.1049
73860029|NCT05074888|147266038|SUPERIORITY|||||||0.726|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.7260
73860030|NCT05074888|147266039|SUPERIORITY|||||||0.6808|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.6808
74027243|NCT03368404|147607648|SUPERIORITY|||||||0.0015||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:~Difficulties with work and handicap"||||0.0015
74027244|NCT03368404|147607648|SUPERIORITY|||||||0.2024||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Giving up makeup"||||0.2024
74027245|NCT03368404|147607648|SUPERIORITY|||||||0.0421||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Acknowledgement of the Disease"||||0.0421
74027246|NCT03368404|147607648|SUPERIORITY|||||||0.3945||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Acceptance of the disease"||||0.3945
74027247|NCT03368404|147607648|SUPERIORITY|||||||0.0536||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Fear for the Future"||||0.0536
74027248|NCT03368404|147607648|SUPERIORITY|||||||0.1998||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Emotional well-being"||||0.1998
74027249|NCT03368404|147607648|SUPERIORITY|||||||0.0306||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) questions:~Global Question"||||0.0306
73966115|NCT00894543|147468408|SUPERIORITY_OR_OTHER||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.||||<0.001
73966116|NCT00894543|147468409|SUPERIORITY_OR_OTHER|||||||0.001|||||||Regression, Linear|||||||0.001
73966117|NCT05623345|147468423|SUPERIORITY||Risk Difference (RD)|36.22|STANDARD_ERROR_OF_MEAN|17.43||0.0377|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0377
73966118|NCT05623345|147468423|SUPERIORITY||Risk Difference (RD)|27.69|STANDARD_ERROR_OF_MEAN|5.68|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
73966119|NCT05623345|147468423|SUPERIORITY||Risk Difference (RD)|24.44|STANDARD_ERROR_OF_MEAN|5.65|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
74027250|NCT03368404|147607649|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
74027251|NCT03368404|147607650|SUPERIORITY||||||>|0.05||||||Significance level 0.05|ANCOVA|Adjustment for baseline||||||>0.05
74027252|NCT03368404|147607651|SUPERIORITY|||||||0.0017||||||Significance level of 0.05|Wilcoxon (Mann-Whitney)|||||||0.0017
74027253|NCT02858193|147607694|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies.|Geometric means ratio|111.63||||0.0482|TWO_SIDED|94.12|100.51|123.99||"treatment p-value reported"|ANOVA||Estimated value and limits are expressed in %|||123.99|100.51|0.0482
74027254|NCT02858193|147607696|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies|geometric means ratio|109.41||||0.0002|TWO_SIDED|94.12|104.93|114.07||"treatment p-value is reported"|ANOVA||Estimated value and limits are expressed in%|||114.07|104.93|0.0002
74085911|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.09||0.6731||95.0|-0.215|0.139|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.139|-0.215|0.6731
74085912|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.098||0.5936||95.0|-0.247|0.142|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.142|-0.247|0.5936
73966120|NCT05623345|147468424|SUPERIORITY||Risk Difference (RD)|43.71|STANDARD_ERROR_OF_MEAN|22.14||0.0483|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0483
73966121|NCT05623345|147468424|SUPERIORITY||Risk Difference (RD)|46.15|STANDARD_ERROR_OF_MEAN|7.62|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
73966122|NCT05623345|147468424|SUPERIORITY||Risk Difference (RD)|52.8|STANDARD_ERROR_OF_MEAN|7.56|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
73966123|NCT05623345|147468425|SUPERIORITY||Risk Difference (RD)|32.26|STANDARD_ERROR_OF_MEAN|18.93||0.0883|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0883
73966124|NCT05623345|147468425|SUPERIORITY||Risk Difference (RD)|9.19|STANDARD_ERROR_OF_MEAN|8.35||0.2713|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2713
73966125|NCT05623345|147468425|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|8.44||0.8872|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.8872
73966126|NCT05623345|147468426|SUPERIORITY||Risk Difference (RD)|23.45|STANDARD_ERROR_OF_MEAN|16.9||0.1654|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.1654
73966127|NCT05623345|147468426|SUPERIORITY||Risk Difference (RD)|26.58|STANDARD_ERROR_OF_MEAN|5.53|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
73966128|NCT05623345|147468426|SUPERIORITY||Risk Difference (RD)|25.84|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
73966129|NCT05623345|147468427|SUPERIORITY||Risk Difference (RD)|43.09|STANDARD_ERROR_OF_MEAN|16.85||0.0106|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0106
73966130|NCT05623345|147468427|SUPERIORITY||Risk Difference (RD)|28.46|STANDARD_ERROR_OF_MEAN|6.22|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
73966131|NCT05623345|147468427|SUPERIORITY||Risk Difference (RD)|23.7|STANDARD_ERROR_OF_MEAN|6.4||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0002
73966132|NCT05623345|147468428|SUPERIORITY||Risk Difference (RD)|30.15|STANDARD_ERROR_OF_MEAN|19.11||0.1147|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.1147
73966133|NCT05623345|147468428|SUPERIORITY||Risk Difference (RD)|29.04|STANDARD_ERROR_OF_MEAN|5.92|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
73966134|NCT05623345|147468428|SUPERIORITY||Risk Difference (RD)|24.99|STANDARD_ERROR_OF_MEAN|5.81|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
73966135|NCT05623345|147468429|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.166||0.514|TWO_SIDED|95.0|-0.22|0.44|||Mixed model repeated measures analysis|||||0.44|-0.22|0.514
73966136|NCT05623345|147468429|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.061||0.01|TWO_SIDED|95.0|-0.28|-0.04|||Mixed model repeated measures analysis|||||-0.04|-0.28|0.010
73966137|NCT05623345|147468429|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.061||0.006|TWO_SIDED|95.0|-0.29|-0.05|||Mixed model repeated measures analysis|||||-0.05|-0.29|0.006
74027255|NCT02858193|147607697|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies.||||||0.593|||||||Friedman|||||||0.5930
74027256|NCT02031146|147607701|OTHER|||||||0.29|||||||Two sample test of proportion in Stata|||||||0.29
74027257|NCT02031146|147607702|OTHER|||||||0.69|||||||Log Rank|||||||0.69
74027258|NCT02031146|147607703|OTHER|||||||0.04|||||||Log Rank|||||||0.04
74027259|NCT01582282|147607711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.64||||0.028|||||||ANCOVA|||||||0.028
74027260|NCT01582282|147607711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.72||||0.009|||||||ANCOVA|||||||0.009
74027261|NCT01582282|147607712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.013|||||||ANCOVA|||||||0.013
74027262|NCT01582282|147607712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.003|||||||ANCOVA|||||||0.003
74027263|NCT01582282|147607713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.808|||||||ANCOVA|||||||0.808
74027264|NCT01582282|147607713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.328|||||||ANCOVA|||||||0.328
74027265|NCT01582282|147607714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1||||0.508|||||||ANCOVA|||||||0.508
74027266|NCT01582282|147607714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.962|||||||ANCOVA|||||||0.962
74027267|NCT01582282|147607715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.84||||0.363|||||||ANCOVA|||||||0.363
74027268|NCT01582282|147607715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.978|||||||ANCOVA|||||||0.978
74027269|NCT01582282|147607716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.14||||0.785|||||||ANCOVA|||||||0.785
74027270|NCT01582282|147607716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.45||||0.811|||||||ANCOVA|||||||0.811
74027271|NCT02495077|147607717|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.099|TWO_SIDED|95.0|-10.73|0.93|||Mixed Models Analysis|||Mean eGFR of the two treatment groups was compared. The p-value, estimated month 24 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence intervals result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group. Random effects for the intercept and eGFR collection day were utilized in the model.||0.93|-10.73|0.099
74027272|NCT02495077|147607718|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
74085913|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.094||0.8368||95.0|-0.206|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.167|-0.206|0.8368
74085914|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.111||0.8659||95.0|-0.242|0.204|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.204|-0.242|0.8659
74085915|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.112||0.7151||95.0|-0.266|0.184|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.184|-0.266|0.7151
73860031|NCT05074888|147266040|SUPERIORITY|||||||0.54||||||"The p-value associated with treatment\*visit interaction of pulse rate (heart rate) from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.54
73860032|NCT05074888|147266041|SUPERIORITY|||||||0.49||||||"The p-value associated with treatment\*visit interaction of respiration rate (breathing rate) from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.49
73860033|NCT05074888|147266042|SUPERIORITY|||||||0.87||||||"The p-value associated with treatment\*visit interaction of systolic blood pressure from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to SBP/Visit1, SBP/Visit2 and SBP/Visit3 rows.||||0.87
73860034|NCT05074888|147266042|SUPERIORITY|||||||0.22||||||"The p-value associated with treatment\*visit interaction of diastolic blood pressure from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to DBP/Visit1, DBP/Visit2 and DBP/Visit3 rows.||||0.22
73860035|NCT05074888|147266043|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73860036|NCT05074888|147266044|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73860037|NCT05074888|147266045|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
73860038|NCT05074888|147266046|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
73860039|NCT03541187|147266054|SUPERIORITY|The comparison between arms will be conducted using an analysis of covariance (ANCOVA) model, in which the change from the baseline to the 12-month TNSS mean serves as the outcome. The ANCOVA model will incorporate factors for treatment while adjusting for both the baseline TNSS mean and site.|Least Square Mean Difference|-0.23||||0.63|TWO_SIDED|95.0|-1.15|0.7|||ANCOVA|||||0.70|-1.15|0.63
73860040|NCT03541187|147266056|SUPERIORITY||Least Square Means Difference|-0.17||||0.69|TWO_SIDED|95.0|-0.99|0.66|||ANCOVA|||||0.66|-0.99|0.69
73860041|NCT03541187|147266057|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.51|TWO_SIDED|95.0|0.42|1.54|||Regression, Cox||At the reactive dose of 15.4 mcg/mL after 12 months, there were 11 participants who were right-censored in the Cockroach SCIT arm and 8 participants who were right-censored in the Placebo arm.|||1.54|0.42|.51
73860042|NCT03541187|147266058|SUPERIORITY||Least Square Means Difference|-0.03||||0.91|TWO_SIDED|95.0|-0.54|0.49|||ANCOVA|||||0.49|-0.54|0.91
73860043|NCT03541187|147266059|SUPERIORITY||Least Square Means Difference|5.32|||<|0.001|TWO_SIDED|95.0|4.77|5.87|||ANCOVA|||||5.87|4.77|<0.001
73915785|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.6||||0.0128|TWO_SIDED|95.0|0.6|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36||4.7|0.6|0.0128
73915786|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1369|TWO_SIDED|95.0|-0.5|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36||3.5|-0.5|0.1369
74027273|NCT02495077|147607719|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
74027274|NCT02495077|147607721|SUPERIORITY|||||||0.746|||||||Fisher Exact|||||||0.746
74027275|NCT02495077|147607722|SUPERIORITY|||||||0.242|||||||Chi-squared|||||||0.242
74027276|NCT02495077|147607724|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
74027277|NCT02495077|147607725|SUPERIORITY|||||||0.497|||||||Fisher Exact|||||||0.497
74027278|NCT02495077|147607726|SUPERIORITY|||||||0.622|||||||Fisher Exact|||||||0.622
74027279|NCT02495077|147607728|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
74027280|NCT02495077|147607729|SUPERIORITY|||||||0.135|||||||Cochran-Mantel-Haenszel|||||||0.135
74027281|NCT02495077|147607730|SUPERIORITY|||||||0.157|||||||Chi-squared|||||||0.157
74027282|NCT02495077|147607731|SUPERIORITY|||||||0.071|||||||Chi-squared|||||||0.071
74027283|NCT02495077|147607732|SUPERIORITY|||||||0.543|||||||t-test, 2 sided|||||||0.543
74027284|NCT02495077|147607733|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
74027285|NCT02495077|147607734|SUPERIORITY|||||||0.275|||||||t-test, 2 sided|||||||0.275
74027286|NCT02495077|147607735|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.300
74027287|NCT02495077|147607736|SUPERIORITY|||||||0.152|||||||t-test, 2 sided|||||||0.152
74027288|NCT02495077|147607737|SUPERIORITY|||||||0.181|||||||t-test, 2 sided|||||||0.181
74085916|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.077||0.2121||95.0|-0.249|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.056|-0.249|0.2121
74027289|NCT02495077|147607738|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.639|TWO_SIDED|95.0|-5.37|3.3|||Mixed Models Analysis|||Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.||3.30|-5.37|0.639
74027290|NCT02495077|147607739|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.51|TWO_SIDED|95.0|-6.22|3.1|||Mixed Models Analysis|||Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.||3.10|-6.22|0.510
74085917|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.077||0.5607||95.0|-0.197|0.107|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.107|-0.197|0.5607
74085918|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.077||0.7797||95.0|-0.13|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.173|-0.130|0.7797
74085919|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.079||0.8761||95.0|-0.143|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.167|-0.143|0.8761
73860044|NCT01310400|147266087|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|4.5||||0.0036|TWO_SIDED|95.0|1.4|7.5||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.||7.5|1.4|0.0036
73860045|NCT01310400|147266087|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|-3.0||||0.1465|TWO_SIDED|95.0|-7.0|1.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.||1.0|-7.0|0.1465
73860046|NCT01310400|147266087|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|8.0|||<|0.001|TWO_SIDED|95.0|3.3|12.7||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.||12.7|3.3|<0.001
73860047|NCT01310400|147266087|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|0.9||||0.7493|TWO_SIDED|95.0|-4.5|6.2||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.||6.2|-4.5|0.7493
73860048|NCT01310400|147266087|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|20.2||||0|TWO_SIDED|95.0|13.5|27.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.||27.0|13.5|0.0000
73860049|NCT01310400|147266087|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|10.7||||0.0029|TWO_SIDED|95.0|3.7|17.6||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.||17.6|3.7|0.0029
73860050|NCT01118520|147266091|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||||||0.78
74027291|NCT02495077|147607739|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.43|TWO_SIDED|95.0|-6.45|2.76|||Mixed Models Analysis|||Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.||2.76|-6.45|0.430
74085920|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.067||0.8619||95.0|-0.121|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.144|-0.121|0.8619
73860051|NCT01118520|147266091|SUPERIORITY|||||||0.89|||||||Mixed Models Analysis|||||||0.89
74085921|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.068||0.7256||95.0|-0.111|0.159|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.159|-0.111|0.7256
73860052|NCT01089023|147266101|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA|||||||<0.0001
73860053|NCT01089023|147266102|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA|||||||<0.0001
73860054|NCT01819129|147266146|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomized treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.15|0.1|||||The estimated parameter i.e mean difference is the estimated treatment difference for Faster aspart vs. NovoRapid (Faster aspart - NovoRapid).|Change from baseline in HbA1c is analysed using a mixed-effect model for repeated measurements including changes from baseline in HbA1c at visit 14, 18, 22, 26, 30 and 36. The model includes treatment, region and continuous glucose monitoring (CGM) strata as fixed effects, subject as random effect, HbA1c at baseline as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.10|-0.15|
73860055|NCT02825966|147266152|EQUIVALENCE|The two one-sided t-test (TOST) was used to test equivalence. Using TOST, equivalence was established at α = 0.05 significance level if a (1-2α)\*100% confidence interval for the average difference in EMAT (WCD-AUDICOR) was contained within the interval \[-12, 12\].|Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|90.0|-2.89|4.69|||two one-sided test (TOST)|||First, the difference in EMAT between the LifeVest and AUDICOR device (first wear) was calculated for each subject. Then the mean and standard deviation of the differences in EMAT were calculated. The 2 devices were considered equivalent if the 90% confidence interval for mean difference in EMAT was within the pre-specified margin of \[-12, 12\] ms.||4.69|-2.89|< 0.001
73860056|NCT02266277|147266153|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.3||||0.0001|TWO_SIDED|95.0|1.15|1.47||Adjusted for age, sex, race and utilization|Regression, Logistic|||||1.47|1.15|0.0001
74085922|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.061||0.8659||95.0|-0.11|0.131|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.131|-0.110|0.8659
74085923|NCT00442546|147725968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.063||0.0203||95.0|0.023|0.27|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.270|0.023|0.0203
74085924|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.074||0.5791||95.0|-0.187|0.105|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.105|-0.187|0.5791
73860057|NCT02266277|147266153|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.2||||0.0026|TWO_SIDED|95.0|1.07|1.36|||Regression, Logistic|||||1.36|1.07|.0026
73860058|NCT02266277|147266153|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.16||||0.0206|TWO_SIDED|95.0|1.02|1.31|||Regression, Logistic|||||1.31|1.02|.0206
73860059|NCT02266277|147266153|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.07||||0.233|TWO_SIDED|95.0|0.96|1.21|||Regression, Logistic|||||1.21|.96|.2330
73860060|NCT02266277|147266153|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio, log|1.12||||0.0579|TWO_SIDED|95.0|0.996|1.26|||Regression, Logistic|||||1.26|.996|.0579
73915787|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6331|TWO_SIDED|95.0|-1.5|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36||2.5|-1.5|0.6331
73915788|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0361|TWO_SIDED|95.0|0.1|4.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36||4.3|0.1|0.0361
74085925|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.075||0.6829||95.0|-0.178|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.117|-0.178|0.6829
74085926|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.07||0.4516||95.0|-0.19|0.085|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.085|-0.190|0.4516
73915789|NCT00256750|147360485|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0525|TWO_SIDED|95.0|0.0|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36||4.2|-0.0|0.0525
74085927|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.071|STANDARD_ERROR_OF_MEAN|0.069||0.3014||95.0|-0.207|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.064|-0.207|0.3014
74085928|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.075||0.7628||95.0|-0.171|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.125|-0.171|0.7628
74085929|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.075||0.711||95.0|-0.176|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.120|-0.176|0.7110
74085930|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.079||0.7382||95.0|-0.183|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.130|-0.183|0.7382
74085931|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.076||0.6586||95.0|-0.183|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.116|-0.183|0.6586
74085932|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.084||0.7691||95.0|-0.195|0.145|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.145|-0.195|0.7691
73915790|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.024|||<|0.0001|TWO_SIDED|95.0|-0.032|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.015|-0.032|<0.0001
73915791|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.019|||<|0.0001|TWO_SIDED|95.0|-0.028|-0.011||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.011|-0.028|<0.0001
73915792|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.023|||<|0.0001|TWO_SIDED|95.0|-0.031|-0.014||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.||-0.014|-0.031|<0.0001
73915793|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.026|||<|0.0001|TWO_SIDED|95.0|-0.035|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.||-0.017|-0.035|<0.0001
73915794|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.024|||<|0.0001|TWO_SIDED|95.0|-0.032|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.016|-0.032|<0.0001
74085933|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.085||0.507||95.0|-0.229|0.115|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.115|-0.229|0.5070
74085934|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.066||0.5802||95.0|-0.166|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.093|-0.166|0.5802
74085935|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.065||0.919||95.0|-0.122|0.136|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.136|-0.122|0.9190
74085936|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.059||0.6559||95.0|-0.09|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.143|-0.090|0.6559
74085937|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.06||0.8552||95.0|-0.108|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.130|-0.108|0.8552
74085938|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.048||0.6364||95.0|-0.072|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.117|-0.072|0.6364
74085939|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.049||0.2127||95.0|-0.035|0.157|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.157|-0.035|0.2127
74085940|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.047||0.8746||95.0|-0.086|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.101|-0.086|0.8746
73915795|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.029|-0.012||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.012|-0.029|<0.0001
73915796|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.026|||<|0.0001|TWO_SIDED|95.0|-0.034|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.||-0.017|-0.034|<0.0001
73915797|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.025|||<|0.0001|TWO_SIDED|95.0|-0.034|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.||-0.016|-0.034|<0.0001
73915798|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.021|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.013|-0.030|<0.0001
73915799|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.015|||<|0.0001|TWO_SIDED|95.0|-0.024|-0.007||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.007|-0.024|<0.0001
73915800|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.023|||<|0.0001|TWO_SIDED|95.0|-0.031|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24||-0.015|-0.031|<0.0001
73915801|NCT00256750|147360486|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.021|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24||-0.013|-0.030|<0.0001
73915802|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4498|TWO_SIDED|95.0|-1.2|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||2.7|-1.2|0.4498
74027292|NCT02495077|147607739|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.328|TWO_SIDED|95.0|-6.86|2.31|||Mixed Models Analysis|||Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.||2.31|-6.86|0.328
74027293|NCT02495077|147607740|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.725|TWO_SIDED|95.0|-5.58|3.89|||Mixed Models Analysis|||Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.||3.89|-5.58|0.725
74027294|NCT02495077|147607741|SUPERIORITY||Mean Difference (Final Values)|-1.35||||0.601|TWO_SIDED|95.0|-6.41|3.72|||Mixed Models Analysis|||Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.||3.72|-6.41|0.601
74085941|NCT00442546|147725969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.048||0.0286||95.0|0.011|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.202|0.011|0.0286
73915803|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0584|TWO_SIDED|95.0|-0.1|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||3.9|-0.1|0.0584
73966138|NCT01772472|147468441|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001||95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<0.0001
73966139|NCT01772472|147468442|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001||95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<0.0001
73966140|NCT01772472|147468443|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<.0001
73966141|NCT01772472|147468444|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<.0001
73966142|NCT01772472|147468445|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001||95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<0.0001
73966143|NCT01772472|147468446|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<.0001
73966144|NCT01772472|147468447|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<0.0001
73966145|NCT01772472|147468448|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<0.0001
73966146|NCT01772472|147468449|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<.0001
73966147|NCT01772472|147468450|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082|TWO_SIDED|95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
73966148|NCT01772472|147468451|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082||95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
73966149|NCT01772472|147468452|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082|TWO_SIDED|95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
73966150|NCT01772472|147468453|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001||95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.0001
73966151|NCT01772472|147468454|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001||95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.0001
73966152|NCT01772472|147468455|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<.0001
73915804|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.1||||0.1595|TWO_SIDED|95.0|-0.5|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||2.7|-0.5|0.1595
73915805|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0457|TWO_SIDED|95.0|0.0|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.3|0.0|0.0457
73915806|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1729|TWO_SIDED|95.0|-0.6|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||3.2|-0.6|0.1729
73915807|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4209|TWO_SIDED|95.0|-1.1|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.7|-1.1|0.4209
73915808|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.6||||0.0526|TWO_SIDED|95.0|0.0|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.2|-0.0|0.0526
73915809|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0077|TWO_SIDED|95.0|0.6|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.9|0.6|0.0077
73915810|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.4||||0.1849|TWO_SIDED|95.0|-0.6|3.4|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||3.4|-0.6|0.1849
73915811|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4633|TWO_SIDED|95.0|-1.3|2.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||2.8|-1.3|0.4633
73915812|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.4||||0.0971|TWO_SIDED|95.0|-0.3|3.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.0|-0.3|0.0971
73915813|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0102|TWO_SIDED|95.0|0.5|3.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.8|0.5|0.0102
73915814|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0186|TWO_SIDED|95.0|0.4|4.5|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.5|0.4|0.0186
73915815|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0775|TWO_SIDED|95.0|-0.2|4.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.0|-0.2|0.0775
74027295|NCT02495077|147607741|SUPERIORITY||Mean Difference (Final Values)|-1.64||||0.519|TWO_SIDED|95.0|-6.66|3.37|||Mixed Models Analysis|||Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.||3.37|-6.66|0.519
74085942|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.165|STANDARD_ERROR_OF_MEAN|0.102||0.1078||95.0|-0.367|0.036|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.036|-0.367|0.1078
73915816|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.6||||0.0768|TWO_SIDED|95.0|-0.2|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.3|-0.2|0.0768
73915817|NCT00256750|147360487|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.2||||0.1876|TWO_SIDED|95.0|-0.6|2.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||2.9|-0.6|0.1876
73915818|NCT00256750|147360489|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|4.2|||||TWO_SIDED|97.3|-1.3|10.1||||||Month 24||10.1|-1.3|
74027296|NCT02495077|147607741|SUPERIORITY||Mean Difference (Final Values)|-2.09||||0.411|TWO_SIDED|95.0|-7.08|2.91|||Mixed Models Analysis|||Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.||2.91|-7.08|0.411
74027297|NCT02495077|147607742|SUPERIORITY|||||||0.569|||||||Chi-squared|||||||0.569
74085943|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.103||0.6406||95.0|-0.252|0.155|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.155|-0.252|0.6406
73915819|NCT00256750|147360489|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.6|||||TWO_SIDED|97.3|-2.2|9.6||||||Month 24||9.6|-2.2|
73915820|NCT00256750|147360489|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.3|||||TWO_SIDED|97.3|-2.9|9.8||||||Month 36||9.8|-2.9|
73915821|NCT00256750|147360489|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.5|||||TWO_SIDED|97.3|-2.8|10.0||||||||10.0|-2.8|
73915822|NCT00256750|147360490|SUPERIORITY_OR_OTHER||Difference in Percent|5.9|||||TWO_SIDED|95.0|-1.0|12.8||||||Month 12||12.8|-1.0|
73915823|NCT00256750|147360490|SUPERIORITY_OR_OTHER||Difference in Percent|11.5|||||TWO_SIDED|95.0|4.2|18.9||||||Month 12||18.9|4.2|
73915824|NCT00256750|147360490|SUPERIORITY_OR_OTHER||Difference in Percent|1.8|||||TWO_SIDED|95.0|-5.5|9.1||||||Month 24||9.1|-5.5|
73915825|NCT00256750|147360490|SUPERIORITY_OR_OTHER||Difference in Percent|9.8|||||TWO_SIDED|95.0|1.9|17.6||||||Month 24||17.6|1.9|
74027298|NCT02495077|147607743|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
74027299|NCT02495077|147607744|SUPERIORITY|||||||0.451|||||||Chi-squared|||||||0.451
74027300|NCT02495077|147607745|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
74027301|NCT02495077|147607746|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.710
74027302|NCT02495077|147607747|SUPERIORITY|||||||0.622|||||||Fisher Exact|||||||0.622
74027303|NCT02495077|147607748|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.256|TWO_SIDED|95.0|-0.36|1.35|||Mixed Models Analysis|||24 Hours/Day 1. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 24 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 24 hours/day 1. A random effect for the intercept was utilized in the model.||1.35|-0.36|0.256
74085944|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.092||0.2404||95.0|-0.289|0.073|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.073|-0.289|0.2404
74085945|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.09||0.1005||95.0|-0.327|0.029|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.029|-0.327|0.1005
74085946|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.136|STANDARD_ERROR_OF_MEAN|0.108||0.2109||95.0|-0.349|0.078|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.078|-0.349|0.2109
73915826|NCT00256750|147360490|SUPERIORITY_OR_OTHER||Difference in Percent|0.9|||||TWO_SIDED|95.0|-6.6|8.4||||||Month 36||8.4|-6.6|
73915827|NCT00256750|147360490|SUPERIORITY_OR_OTHER||Difference in Percent|8.4|||||TWO_SIDED|95.0|0.4|16.4||||||Month 36||16.4|0.4|
73915828|NCT01362205|147360501|OTHER|||||||0.2454|||||||Wilcoxon (Mann-Whitney)|||||||0.2454
73915829|NCT05405309|147360541|OTHER||||||||||||||||||"The primary analysis was of safety and included all patients who received at least one dose of the investigational regimen. The rate of adverse events was estimated after the first 5 patients were treated at Original DL1 (camonsertib 40mg daily and olaparib 100mg BID dosing 2 days per week, at 28 day cycles)~After the first 5 patients were treated, it was determined that this dosing strategy may not be appropriate for R/R CLL patients and reduced dosing frequency may be necessary to increase the safety of the combination therapy. The protocol and DLs were amended, and sought to enroll an additional 18 patients.~Before the enrollment of 18 additional participants and MTD determination, the study was terminated due to sponsor de-activation of all programs associated with camonsertib."|||
73915830|NCT05425745|147360552|SUPERIORITY||Least Squares (LS) Means|-36.31|STANDARD_ERROR_OF_MEAN|3.019|<|0.0001|TWO_SIDED|95.0|-42.22|-30.39|||ANCOVA|||||-30.39|-42.22|<.0001
74085947|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.108||0.2399||95.0|-0.342|0.086|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.086|-0.342|0.2399
73915831|NCT05425745|147360553|SUPERIORITY||Least Squares (LS) Means|-37.78|STANDARD_ERROR_OF_MEAN|3.572|<|0.0001|TWO_SIDED|95.0|-44.79|-30.78|||ANCOVA|||||-30.78|-44.79|<.0001
73915832|NCT05425745|147360554|SUPERIORITY||Least Squares (LS) Means|-41.45|STANDARD_ERROR_OF_MEAN|4.938|<|0.0001|TWO_SIDED|95.0|-51.14|-31.76||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-31.76|-51.14|<.0001
73915833|NCT05425745|147360555|SUPERIORITY||Least Squares (LS) Means|-24.39|STANDARD_ERROR_OF_MEAN|2.136|<|0.0001|TWO_SIDED|95.0|-28.58|-20.2||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-20.20|-28.58|<.0001
73915834|NCT05425745|147360556|SUPERIORITY||Least Squares (LS) Means|-24.32|STANDARD_ERROR_OF_MEAN|2.583|<|0.0001|TWO_SIDED|95.0|-29.38|-19.25||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.25|-29.38|<.0001
73915835|NCT05425745|147360557|SUPERIORITY||Least Squares (LS) Means|-25.77|STANDARD_ERROR_OF_MEAN|3.114|<|0.0001|TWO_SIDED|95.0|-31.88|-19.67||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.67|-31.88|<.0001
73915836|NCT05425745|147360558|SUPERIORITY||Least Squares (LS) Means|-34.45|STANDARD_ERROR_OF_MEAN|2.661|<|0.0001|TWO_SIDED|95.0|-39.67|-29.24||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-29.24|-39.67|<.0001
73915837|NCT05425745|147360559|SUPERIORITY||Least Squares (LS) Means|-33.0|STANDARD_ERROR_OF_MEAN|3.241|<|0.0001|TWO_SIDED|95.0|-39.36|-26.65||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.65|-39.36|<.0001
73915838|NCT05425745|147360560|SUPERIORITY||Least Squares (LS) Means|-37.48|STANDARD_ERROR_OF_MEAN|4.535|<|0.0001|TWO_SIDED|95.0|-46.38|-28.58||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||-28.58|-46.38|<.0001
73915839|NCT05425745|147360561|SUPERIORITY||Least Squares (LS) Means|138.66|STANDARD_ERROR_OF_MEAN|6.244|<|0.0001|TWO_SIDED|95.0|126.42|150.9||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||150.90|126.42|<.0001
73915840|NCT05425745|147360562|SUPERIORITY||Least Squares (LS) Means|131.2|STANDARD_ERROR_OF_MEAN|6.595|<|0.0001|TWO_SIDED|95.0|118.27|144.13||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||144.13|118.27|<.0001
73915841|NCT05425745|147360563|SUPERIORITY||Least Squares (LS) Means|121.39|STANDARD_ERROR_OF_MEAN|7.333|<|0.0001|TWO_SIDED|95.0|107.02|135.76||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||135.76|107.02|<.0001
73915842|NCT05425745|147360564|SUPERIORITY||Least Squares (LS) Means|-45.94|STANDARD_ERROR_OF_MEAN|10.14|<|0.0001|TWO_SIDED|95.0|-65.88|-26.0||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.00|-65.88|<.0001
74027304|NCT02495077|147607748|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.391|TWO_SIDED|95.0|-0.48|1.23|||Mixed Models Analysis|||48 Hours/Day 2. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 48 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 48 hours/day 2. A random effect for the intercept was utilized in the model.||1.23|-0.48|0.391
73915843|NCT05425745|147360565|SUPERIORITY||Least Squares (LS) Means|-54.3|STANDARD_ERROR_OF_MEAN|38.924||0.1648|TWO_SIDED|95.0|-131.13|22.53||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints|ANCOVA|||||22.53|-131.13|0.1648
73915844|NCT02820753|147360573|SUPERIORITY||Mean Difference (Net)|0.26||||0.04|TWO_SIDED|95.0|0.01|0.51||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||Treatment difference = (Text or Portal) - Enhanced Usual Care|||0.51|0.01|0.04
73915845|NCT02820753|147360574|SUPERIORITY||Mean Difference (Net)|0.04||||0.53|TWO_SIDED|95.0|-0.08|0.15||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||Treatment Difference = (Text or Portal - Enhanced Usual Care|||0.15|-0.08|0.53
73915846|NCT02820753|147360575|SUPERIORITY||Mean Difference (Net)|-0.34||||0.41|TWO_SIDED|95.0|-1.16|0.48||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment Difference = (Text or Portal) - Enhanced Usual Care|||0.48|-1.16|0.41
73915847|NCT02820753|147360576|SUPERIORITY||Mean Difference (Net)|1.83||||0.27|TWO_SIDED|95.0|-1.39|5.06||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment difference = (Text or Portal ) - Enhanced Usual Care|||5.06|-1.39|0.27
73915848|NCT02820753|147360577|SUPERIORITY||Mean Difference (Net)|-0.23||||0.33|TWO_SIDED|95.0|-0.68|0.23||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment Difference = (Text or Portal) - Enhanced Usual Care|||0.23|-0.68|0.33
73915849|NCT03761277|147360585|NON_INFERIORITY|This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, i.e., the change in pain intensity is not greater than 0 by more than 10 points from Baseline to the 6-Month Visit, with change calculated as 6-Month - Baseline.|Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|25.0|<|0.001|ONE_SIDED|97.5||-7.1|||Wilcoxon Signed Rank test|||This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, i.e., the change in pain intensity is not greater than 0 by more than 10 points from Baseline to the 6-Month Visit.|Due to non-normality, the non-inferiority test was conducted using a Wilcoxon Signed Rank test, rather than a one-sample t-test. Mean reduction in VAS and the upper 97.5% confidence limit are presented, but the change from baseline was evaluated using non-parametric analysis methods.|-7.1||< 0.001
74027305|NCT02495077|147607748|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.199|TWO_SIDED|95.0|-0.3|1.42|||Mixed Models Analysis|||72 Hours/Day 3. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 72 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 72 hours/day 3. A random effect for the intercept was utilized in the model.||1.42|-0.30|0.199
74027306|NCT02495077|147607749|SUPERIORITY|||||||0.812|||||||Log Rank|||||||0.812
74027307|NCT02495077|147607750|SUPERIORITY|||||||0.576|||||||Chi-squared|||||||0.576
74027308|NCT02495077|147607751|SUPERIORITY|||||||0.311|||||||t-test, 2 sided|||||||0.311
74027309|NCT02495077|147607752|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||||||0.418
74027310|NCT02495077|147607753|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.030
74085948|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.131|STANDARD_ERROR_OF_MEAN|0.108||0.2272||95.0|-0.346|0.083|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.083|-0.346|0.2272
74085949|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.104||0.4417||95.0|-0.285|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.125|-0.285|0.4417
74027311|NCT02495077|147607754|SUPERIORITY|||||||0.153|||||||Chi-squared|||||||0.153
74027312|NCT02495077|147607755|SUPERIORITY|||||||0.171|||||||Fisher Exact|||||||0.171
74027313|NCT02495077|147607756|SUPERIORITY|||||||0.163|||||||Chi-squared|||||||0.163
74027314|NCT02495077|147607757|SUPERIORITY|||||||0.572|||||||Chi-squared|||||||0.572
74027315|NCT02495077|147607758|SUPERIORITY|||||||0.973|||||||Chi-squared|||||||0.973
74085950|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.144||0.9502||95.0|-0.299|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.281|-0.299|0.9502
74027316|NCT02495077|147607759|SUPERIORITY|||||||0.152|||||||Chi-squared|||||||0.152
74027317|NCT02495077|147607760|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
74027318|NCT02495077|147607761|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
74085951|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.144||0.355||95.0|-0.426|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.156|-0.426|0.3550
74085952|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.122|STANDARD_ERROR_OF_MEAN|0.092||0.1888||95.0|-0.304|0.06|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.060|-0.304|0.1888
74027319|NCT02495077|147607762|SUPERIORITY|||||||0.347|||||||Chi-squared|||||||0.347
74027320|NCT03726671|147607763|OTHER|||||||0.0247|||||||Repeated measures ANOVA|||Betaine IER||||0.0247
74027321|NCT03726671|147607763|OTHER||||||<|0.0001|||||||Repeated measures ANOVA|||Choline IER||||<0.0001
74027322|NCT03726671|147607763|OTHER|||||||0.0002|||||||Repeated measures ANOVA|||Phosphatidylcholine IER||||0.0002
74027323|NCT03726671|147607764|OTHER||Odds Ratio (OR)|7.16|||<|0.001|TWO_SIDED|95.0|3.48|14.7|||Fisher Exact|||||14.7|3.48|<0.001
74027324|NCT03726671|147607764|OTHER||Odds Ratio (OR)|4.09||||0.01|TWO_SIDED|95.0|2.06|8.11|||Fisher Exact|||||8.11|2.06|0.01
74027325|NCT03726671|147607764|OTHER||Odds Ratio (OR)|1.75||||0.086|TWO_SIDED|95.0|0.86|3.58|||Fisher Exact|||||3.58|0.86|0.086
74027326|NCT03726671|147607765|OTHER|||||||0.6985|||||||t-test, 2 sided|||Betaine IER||||0.6985
74027327|NCT03726671|147607765|OTHER|||||||0.035|||||||t-test, 2 sided|||Choline IER||||0.0350
74027328|NCT03726671|147607765|OTHER|||||||0.6864|||||||t-test, 2 sided|||Phosphatidylcholine IER||||0.6864
74027329|NCT03726671|147607766|EQUIVALENCE|There are linear combinations of metabolites that differentiate (non-equivalent) the 25% choline diet from the 100% choline diet.|||||<|0.049|||||||Paired 2-sided t-test||||Supervised OPLSDA was used to determine the variable importance to projections of metabolites/signals that differentiated the 25% and 100% choline diet arms.|||<0.049
74027330|NCT03726671|147607767|OTHER|||||||0.9567|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Pre-Menopausal Females||||0.9567
74027331|NCT03726671|147607767|OTHER|||||||0.0899|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Post-Menopausal Females||||0.0899
74027332|NCT03726671|147607767|OTHER|||||||0.9003|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Males||||0.9003
74027333|NCT03726671|147607767|OTHER|||||||0.9932|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Pre-Menopausal Females||||0.9932
74027334|NCT03726671|147607767|OTHER|||||||0.3984|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Post-Menopausal Females||||0.3984
74027335|NCT03726671|147607767|OTHER|||||||0.308|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Males||||0.3080
74027336|NCT03726671|147607767|OTHER|||||||0.7603|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Pre-Menopausal Females||||0.7603
74027337|NCT03726671|147607767|OTHER|||||||0.2995|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Post-Menopausal Females||||0.2995
74085953|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.092||0.3774||95.0|-0.262|0.1|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.100|-0.262|0.3774
74027338|NCT03726671|147607767|OTHER|||||||0.0003|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Males||||0.0003
74027339|NCT03726671|147607767|OTHER|||||||0.1303|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Pre-Menopausal Females||||0.1303
74027340|NCT03726671|147607767|OTHER|||||||0.0015|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Post-Menopausal Females||||0.0015
74027341|NCT03726671|147607767|OTHER|||||||0.4185|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Males||||0.4185
74085954|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.087||0.9452||95.0|-0.178|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.166|-0.178|0.9452
74085955|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.089||0.7663||95.0|-0.201|0.148|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.148|-0.201|0.7663
74085956|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.074||0.5777||95.0|-0.104|0.186|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.186|-0.104|0.5777
74085957|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.075||0.2916||95.0|-0.069|0.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.227|-0.069|0.2916
73915850|NCT03761277|147360585|SUPERIORITY|This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit are less than VAS at Baseline, i.e., the reduction in pain intensity is less than 0 from Baseline to the 6-Month Visit, with change calculated as 6-Month - Baseline.|Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|25.0|<|0.001|TWO_SIDED|95.0|-22.7|-7.1|||Wilcoxon Signed Rank test|||This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit are less than VAS at Baseline, i.e., the reduction in pain intensity is less than 0 from Baseline to the 6-Month Visit.|Due to non-normality, the superiority test was conducted using a Wilcoxon Signed Rank test, rather than a one-sample t-test. Mean reduction in VAS and 95% confidence interval are presented, but the change from baseline was evaluated using non-parametric analysis methods.|-7.1|-22.7|< 0.001
73915851|NCT00429273|147360593|OTHER|Test for differences in treatment outcomes between three different tx|F-Value for variance component|18.9|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Analyses are based on a generalized linear mixed model (GLMM) modelling the effects of the medication when calibrated to optimal dosage and controlling for time effects and within-subject effects. The design is a combined within-between subject design, where each participant is exposed to, and provides information about multiple tx modalities.||||<.01
73915852|NCT01438957|147360594|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
73915853|NCT01438957|147360594|SUPERIORITY|||||||0.003|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.003
73915854|NCT01438957|147360594|SUPERIORITY|||||||0.086|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.086
73915855|NCT01438957|147360594|SUPERIORITY||||||<|0.001|||||||Mantel-extension test|Stratified by the anesthesia type||Dose-response relationship is assessed using Mantel-extension test. In this analysis, dose of placebo group is hypothesized as 0 microg/kg. Dose-response relationship among Dexmedetomidine 4 dose groups excluding placebo group is also assessed using Mantel-extension test.||||<0.001
74085958|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.069||0.8389||95.0|-0.15|0.122|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.122|-0.150|0.8389
73915856|NCT01438957|147360595|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
73915857|NCT01438957|147360595|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||<0.001
73915858|NCT01438957|147360595|SUPERIORITY|||||||0.006|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.006
73915859|NCT01438957|147360595|SUPERIORITY|||||||0.329|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.329
73915860|NCT01438957|147360596|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
73915861|NCT01438957|147360596|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||<0.001
73915862|NCT01438957|147360596|SUPERIORITY|||||||0.006|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.006
73915863|NCT01438957|147360596|SUPERIORITY|||||||0.371|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.371
74027342|NCT03726671|147607767|OTHER|||||||0.3464|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Pre-Menopausal Females||||0.3464
74027343|NCT03726671|147607767|OTHER|||||||0.0019|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Post-Menopausal Females||||0.0019
73966153|NCT02697136|147468470|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study. Using an assumed standard deviation of 4.5% and a 2:1 randomization scheme to maximize exposure to active drug, 16 completing patients in the CER-001 group and 8 in the placebo group (24 total completers for mITT) would yield 90% power to detect a difference from baseline versus placebo of 6.7%, using two-tailed testing with α=0.05.|Difference in LS Means|-0.08||||0.185|TWO_SIDED|95.0|-1.9|0.4|||Mixed Models Analysis|||||0.4|-1.9|0.185
73966154|NCT02697136|147468471|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study.|Difference in LS Means|0.7||||0.217|TWO_SIDED|95.0|-0.4|1.8|||Mixed Models Analysis|||||1.8|-0.4|0.217
73966155|NCT02697136|147468472|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study.|Difference in LS Means|-0.2||||0.832|TWO_SIDED|95.0|-1.6|1.3|||Mixed Models Analysis|||||1.3|-1.6|0.832
73966156|NCT05198310|147468552|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.281||0.047|TWO_SIDED|95.0|-1.13|-0.01||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||-0.01|-1.13|0.0470
73966157|NCT05198310|147468552|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.282||0.2124|TWO_SIDED|95.0|-0.92|0.21||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||0.21|-0.92|0.2124
73966158|NCT05198310|147468552|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.352||0.1091|TWO_SIDED|95.0|-1.28|0.13||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||0.13|-1.28|0.1091
73966159|NCT05198310|147468553|SUPERIORITY|||||||0.0312|||||||t-test|||||||0.0312
73966160|NCT05198310|147468553|SUPERIORITY|||||||0.0338|||||||t-test|||||||0.0338
73966161|NCT05198310|147468557|SUPERIORITY|||||||0.0333|||||||Fisher exact test|||||||0.0333
73966162|NCT05198310|147468557|SUPERIORITY|||||||0.1905|||||||Fisher exact test|||||||0.1905
73966163|NCT05198310|147468557|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0716|TWO_SIDED|95.0|0.9|9.65|||Cochran-Mantel-Haenszel|||||9.65|0.90|0.0716
73966164|NCT05198310|147468557|SUPERIORITY||Odds Ratio (OR)|1.52||||0.471|TWO_SIDED|95.0|0.5|4.67|||Cochran-Mantel-Haenszel|||||4.67|0.50|0.4710
73966165|NCT05198310|147468557|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0057|TWO_SIDED|95.0|1.62|22.88|||Cochran-Mantel-Haenszel|||||22.88|1.62|0.0057
73966166|NCT05198310|147468558|SUPERIORITY|||||||0.0762|||||||Fisher exact test|||||||0.0762
73966167|NCT05198310|147468558|SUPERIORITY|||||||1|||||||Fisher exact test|||||||1.000
73966168|NCT05198310|147468558|SUPERIORITY||Odds Ratio (OR)|1.67||||0.4172|TWO_SIDED|95.0|0.49|5.62|||Cochran-Mantel-Haenszel|||||5.62|0.49|0.4172
73966169|NCT05198310|147468558|SUPERIORITY||Odds Ratio (OR)|1.89||||0.3144|TWO_SIDED|95.0|0.55|6.45|||Cochran-Mantel-Haenszel|||||6.45|0.55|0.3144
73966170|NCT05198310|147468558|SUPERIORITY||Odds Ratio (OR)|0.97||||0.956|TWO_SIDED|95.0|0.28|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.28|0.9560
73966171|NCT05198310|147468559|SUPERIORITY|||||||0.4667|||||||Fisher exact test|||||||0.4667
73966172|NCT05198310|147468559|SUPERIORITY|||||||1|||||||Fisher exact test|||||||1.0000
73966173|NCT05198310|147468559|SUPERIORITY||Odds Ratio (OR)|1.95||||0.5789|TWO_SIDED|95.0|0.17|22.3|||Cochran-Mantel-Haenszel|||||22.30|0.17|0.5789
73966174|NCT05198310|147468559|SUPERIORITY||Odds Ratio (OR)|6.12||||0.0799|TWO_SIDED|95.0|0.62|60.1|||Cochran-Mantel-Haenszel|||||60.10|0.62|0.0799
73966175|NCT05198310|147468559|SUPERIORITY||Odds Ratio (OR)|0.28||||0.1034|TWO_SIDED|95.0|0.06|1.35|||Cochran-Mantel-Haenszel|||||1.35|0.06|0.1034
73966176|NCT01095796|147468602|NON_INFERIORITY_OR_EQUIVALENCE|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA \< 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.6|||||TWO_SIDED|95.2|-1.6|8.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (as defined by the snapshot analysis algorithm) at Week 48 in the Stribild group is at least 12% worse than the response rate in the Atripla group; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the Atripla Group.||8.8|-1.6|
73966177|NCT03144518|147468640|SUPERIORITY||Partial Eta Squared|0.079||||0.005|TWO_SIDED|90.0|0.014|0.173||ANCOVA, controlling for pre-intervention levels|ANCOVA|ANCOVA, controlling for pre-intervention levels||VAS-Valence Scores||.173|.014|.005
73966178|NCT03144518|147468640|SUPERIORITY||Partial Eta-Squared|0.04||||0.047|TWO_SIDED|90.0|0.0|0.12|||ANCOVA|Controlling for pre-intervention scores||VAS-Arousal Scores||.120|.000|.047
73966179|NCT03144518|147468640|SUPERIORITY||Partial Eta Squared|0.096||||0.002|TWO_SIDED|90.0|0.022|0.196|||ANCOVA|Controlling for pre-intervention levels||Pictorial Scale||.196|.022|.002
73966180|NCT03144518|147468640|SUPERIORITY||Partial Eta Squared|0.002||||0.697|TWO_SIDED|90.0|0.0|0.036|||ANCOVA|Controlling for baseline levels||PANAS Positive Affect Scores||.036|.000|.697
73966181|NCT03144518|147468640|SUPERIORITY||Partial Eta Squared|0.005||||0.462|TWO_SIDED|90.0|0.0|0.053|||ANCOVA|||PANAS Negative Affect Scores||.053|.000|.462
73966182|NCT03144518|147468643|SUPERIORITY||Partial Eta Squared|0.001||||0.806|TWO_SIDED|90.0|0.0|0.031|||ANCOVA|Controlling for pre-intervention levels||||.031|.000|.806
73966183|NCT03144518|147468644|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.006||||0.438|TWO_SIDED|90.0|0.0|0.055|||ANCOVA|Controlling for Pre-Vaccination levels||4 Weeks A/Hong-Kong||.055|.000|.438
73966184|NCT03144518|147468644|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.004||||0.516|TWO_SIDED|90.0|0.0|0.051|||ANCOVA|controlling for pre-vaccination levels||A/Hong-Kong 16 Weeks Post-Vaccination||.051|.000|.516
73860061|NCT02266277|147266153|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|0.99||||0.87|TWO_SIDED|95.0|0.86|1.14|||Regression, Logistic|||||1.14|.86|.87
73860062|NCT02266277|147266154|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.03||||0.82|TWO_SIDED|95.0|0.81|1.31|||Regression, Logistic|||||1.31|.81|.82
73860063|NCT02266277|147266154|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio, log|0.9||||0.36|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic|||||1.13|.71|.36
73860064|NCT02266277|147266154|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.89||||0.33|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic|||||1.13|.71|.33
73860065|NCT02266277|147266154|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.87||||0.23|TWO_SIDED|95.0|0.69|1.09|||Regression, Logistic|||||1.09|.69|.23
73860066|NCT02266277|147266154|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.99||||0.96|TWO_SIDED|95.0|0.79|1.25|||Regression, Logistic|||||1.25|.79|.96
73860067|NCT02266277|147266154|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.04||||0.76|TWO_SIDED|95.0|0.82|1.31|||Regression, Logistic|||||1.31|.82|.76
73860068|NCT02836873|147266156|SUPERIORITY||Difference of LS Means|-0.28||||0.0026|TWO_SIDED|95.0|-0.46|-0.1|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||This is a mixed-effects repeated measures analysis including region, screening anti-diabetic treatment regimen, baseline eGFR, treatment, visit, treatment-by-visit interaction and baseline HbA1c as a fixed effect covariate. Data from Weeks 6, 12, and 24 are used in the model.||-0.10|-0.46|0.0026
73915864|NCT01438957|147360597|SUPERIORITY||||||<|0.001|||||||Log Rank|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
73860069|NCT02836873|147266157|SUPERIORITY||Difference of LS Means|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.03|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||-1.03|-2.50|< 0.0001
73860070|NCT02836873|147266158|SUPERIORITY||Difference of LS Means|-2.63||||0.2035|TWO_SIDED|95.0|-6.7|1.44|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||1.44|-6.70|0.2035
73860071|NCT02836873|147266159|SUPERIORITY||Difference of LS Means|-0.2||||0.1156|TWO_SIDED|95.0|-0.44|0.05|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||0.05|-0.44|0.1156
73860072|NCT02836873|147266160|SUPERIORITY||Difference of LS Means|-0.37||||0.0078|TWO_SIDED|95.0|-0.65|-0.1|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||-0.10|-0.65|0.0078
73860073|NCT02214225|147266176|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.92|||||TWO_SIDED|95.0|0.87|0.98||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.87|
73860074|NCT02214225|147266176|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.93|||||TWO_SIDED|95.0|0.88|0.98||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.88|
73915865|NCT01438957|147360597|SUPERIORITY|||||||0.001|||||||Log Rank|Stratified by the anesthesia type||||||0.001
73915866|NCT01438957|147360597|SUPERIORITY|||||||0.212|||||||Log Rank|Stratified by the anesthesia type||||||0.212
74085959|NCT00442546|147725970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.07||0.0734||95.0|-0.012|0.266|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.266|-0.012|0.0734
73860075|NCT02214225|147266176|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.87|||||TWO_SIDED|95.0|0.81|0.93||||||For B/Yamagata strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.93|0.81|
73860076|NCT02214225|147266176|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.94|||||TWO_SIDED|95.0|0.86|1.01||||||For B/Victoria strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.01|0.86|
73860077|NCT02214225|147266177|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-1.1|||||TWO_SIDED|95.0|-4.4|2.2||||||||2.2|-4.4|
73860078|NCT02214225|147266177|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-1.7|||||TWO_SIDED|95.0|-5.0|1.6||||||||1.6|-5.0|
73860079|NCT02214225|147266177|NON_INFERIORITY_OR_EQUIVALENCE|For B/Yamagata. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-3.2|||||TWO_SIDED|95.0|-7.0|0.5||||||||0.5|-7.0|
73860080|NCT02214225|147266177|NON_INFERIORITY_OR_EQUIVALENCE|For B/Victoria. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-1.6|||||TWO_SIDED|95.0|-5.6|2.4||||||||2.4|-5.6|
73860081|NCT02214225|147266178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.93|||||TWO_SIDED|95.0|0.85|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.85|
73860082|NCT02214225|147266178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.91|||||TWO_SIDED|95.0|0.83|0.99||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.99|0.83|
73860083|NCT02214225|147266178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.86|||||TWO_SIDED|95.0|0.76|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.97|0.76|
73915867|NCT01438957|147360598|SUPERIORITY|||||||0.869|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.869
74085960|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.084||0.1949||95.0|-0.276|0.057|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.057|-0.276|0.1949
74085961|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.052|STANDARD_ERROR_OF_MEAN|0.085||0.5431||95.0|-0.22|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.116|-0.220|0.5431
73860084|NCT02214225|147266178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.86|||||TWO_SIDED|95.0|0.76|0.98||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.76|
73860085|NCT02214225|147266178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.95|||||TWO_SIDED|95.0|0.88|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.88|
73915868|NCT01438957|147360599|SUPERIORITY|||||||0.897|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.897
73915869|NCT01438957|147360600|SUPERIORITY|||||||0.897|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.897
73966185|NCT03144518|147468644|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.002||||0.671|TWO_SIDED|90.0|0.0|0.038|||ANCOVA|controlling for pre-vaccination levels||A/Michigan 4 weeks post-vaccination||.038|.000|.671
73966186|NCT03144518|147468644|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.0||||0.98|TWO_SIDED|90.0|0.0|0.0|||ANCOVA|Controlling for pre-vaccination levels||A/Michigan 16 weeks post-vaccination||.000|.000|.980
73966187|NCT03144518|147468644|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.409|TWO_SIDED|90.0|0.0|0.057|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 4 weeks post-vaccination||.057|.000|.409
73966188|NCT03144518|147468644|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.008||||0.377|TWO_SIDED|90.0|0.0|0.062|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 16 weeks post-vaccination||.062|.000|.377
73966189|NCT03144518|147468644|SUPERIORITY||Partial Eta Squared|0.0||||0.892|TWO_SIDED|90.0|0.0|0.008|||ANCOVA|Controlling for pre-vaccination levels||B/Phuket 4 weeks post-vaccination||.008|.000|.892
73966190|NCT03144518|147468644|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.426|TWO_SIDED|90.0|0.0|0.058|||ANCOVA|Controlling for pre-vaccination levels||||.058|.000|.426
73966191|NCT01989455|147468652|SUPERIORITY_OR_OTHER||Percent ratio|73.19|||||TWO_SIDED|90.0|68.83|77.56||||||||77.56|68.83|
73966192|NCT02638337|147468654|SUPERIORITY||LS Mean Difference|-21.8|||<|0.0001|TWO_SIDED|95.0|-25.7|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||For the percentage of parabasal cells a mixed-effects model for repeated measures (MMRM) approach was used, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||-18.0|-25.7|<0.0001
73966193|NCT02638337|147468655|SUPERIORITY||LS Mean Difference|7.2|||<|0.0001|TWO_SIDED|95.0|5.2|9.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||||9.1|5.2|<0.0001
73966194|NCT02638337|147468656|SUPERIORITY||LS Mean Difference|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.84|-0.59|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||||-0.59|-0.84|<0.0001
73966195|NCT02638337|147468657|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.62|3.06|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|For the MBS of vaginal dryness a generalized estimating equations (GEE) model was used to fit a marginal proportional odds model to the longitudinal ordered categorical data, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline severity of dryness modeled as a covariate.||3.06|1.62|<0.0001
73966196|NCT02638337|147468659|SUPERIORITY||LS Mean Difference|-21.6|||<|0.0001|TWO_SIDED|95.0|-25.2|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||-18.0|-25.2|<0.0001
73966197|NCT02638337|147468659|SUPERIORITY||LS Mean Difference|-21.8|||<|0.0001|TWO_SIDED|95.0|-25.4|-18.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||-18.1|-25.4|<0.0001
73966198|NCT02638337|147468660|SUPERIORITY||LS Mean Difference|5.8|||<|0.0001|TWO_SIDED|95.0|4.2|7.3|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||7.3|4.2|<0.0001
73966199|NCT02638337|147468660|SUPERIORITY||LS Mean Difference|7.2|||<|0.0001|TWO_SIDED|95.0|5.5|9.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||9.0|5.5|<0.0001
73966200|NCT02638337|147468661|SUPERIORITY||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.46|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||-0.46|-0.69|<0.0001
73966201|NCT02638337|147468661|SUPERIORITY||LS Mean Difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.51|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||-0.51|-0.75|<0.0001
73966202|NCT02638337|147468662|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0005|TWO_SIDED|95.0|1.27|2.36|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.36|1.27|0.0005
73966203|NCT02638337|147468662|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.47|2.74|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.74|1.47|<0.0001
73966204|NCT02638337|147468663|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6263|TWO_SIDED|95.0|0.55|1.43|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||1.43|0.55|0.6263
73966205|NCT02638337|147468663|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7869|TWO_SIDED|95.0|0.66|1.75|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||1.75|0.66|0.7869
74085962|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.095|STANDARD_ERROR_OF_MEAN|0.077||0.2164||95.0|-0.247|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.056|-0.247|0.2164
73915870|NCT01438957|147360601|SUPERIORITY||||||<|0.001|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
73915871|NCT01438957|147360601|SUPERIORITY|||||||0.002|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.002
73915872|NCT01438957|147360601|SUPERIORITY|||||||0.116|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.116
73915873|NCT01438957|147360602|SUPERIORITY|||||||0.088|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.088
73915874|NCT01438957|147360603|SUPERIORITY|||||||0.085|||||||Log Rank|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.085
73915875|NCT01438957|147360604|SUPERIORITY|||||||0.005|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.005
73915876|NCT01438957|147360604|SUPERIORITY|||||||0.014|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.014
73915877|NCT01438957|147360604|SUPERIORITY|||||||0.055|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.055
74085963|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.117|STANDARD_ERROR_OF_MEAN|0.076||0.1251||95.0|-0.266|0.033|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.033|-0.266|0.1251
73915878|NCT01438957|147360605|SUPERIORITY|||||||0.737|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.737
73915879|NCT01438957|147360606|SUPERIORITY|||||||0.11|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.11
73915880|NCT01438957|147360607|SUPERIORITY|||||||0.567|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.567
73966206|NCT02638337|147468663|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8894|TWO_SIDED|95.0|0.65|1.64|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||1.64|0.65|0.8894
74085964|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.088||0.4079||95.0|-0.247|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.101|-0.247|0.4079
73915881|NCT01438957|147360608|SUPERIORITY|||||||0.044|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.044
73915882|NCT01438957|147360608|SUPERIORITY|||||||0.234|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.234
73966207|NCT02638337|147468664|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8369|TWO_SIDED|95.0|0.4|2.1|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.10|0.40|0.8369
73966208|NCT02638337|147468664|SUPERIORITY||Odds Ratio (OR)|1.51||||0.397|TWO_SIDED|95.0|0.58|3.95|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||3.95|0.58|0.3970
74085965|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.088||0.4562||95.0|-0.24|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.108|-0.240|0.4562
74085966|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.093||0.4526||95.0|-0.254|0.114|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.114|-0.254|0.4526
73915883|NCT01438957|147360609|SUPERIORITY|||||||0.729|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.729
73915884|NCT01438957|147360610|SUPERIORITY|||||||0.082|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.082
73915885|NCT01438957|147360611|SUPERIORITY|||||||0.451|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.451
73915886|NCT01438957|147360612|SUPERIORITY|||||||0.873|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.873
73915887|NCT01438957|147360613|SUPERIORITY|||||||0.374|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.374
74085967|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.089||0.6186||95.0|-0.221|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.132|-0.221|0.6186
74085968|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.109||0.8712||95.0|-0.237|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.202|-0.237|0.8712
73860086|NCT02214225|147266178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.95|||||TWO_SIDED|95.0|0.89|1.02||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.89|
73915888|NCT02548650|147360654|NON_INFERIORITY|Under the null hypothesis that the mean aggregation between dual and triple therapy is not equal to 0 and a common standard deviation of 13%, a sample size of 28 patients per group with a valid primary end point time point allowed for the 95% confidence interval (CI) to stay within ± 10% with a 80% power and a two-sided alpha=0.05.|Mean Difference (Net)|12.0|||>|0.05|TWO_SIDED|95.0|3.0|21.0|||ANOVA|||The primary end point of our study was the comparison of CAT-induced MPA measured by LTA between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy. We hypothesized that dual therapy would be non-inferior to triple therapy after 30±5 days of treatment||21|3|>0.05
73915889|NCT00407797|147360705|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Percent change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
73915890|NCT00407797|147360706|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<.0001
73915891|NCT00407797|147360707|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Percent change evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
73915892|NCT00407797|147360708|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Participants with \<= 6 seizures during Baseline period.||||<.0001
73966209|NCT02638337|147468664|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5391|TWO_SIDED|95.0|0.54|3.26|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||3.26|0.54|0.5391
73966210|NCT02638337|147468665|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0095|TWO_SIDED|95.0|1.13|2.4|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.40|1.13|0.0095
73966211|NCT02638337|147468665|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0542|TWO_SIDED|95.0|0.99|2.11|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.11|0.99|0.0542
73966212|NCT02638337|147468665|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0004|TWO_SIDED|95.0|1.35|2.88|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||2.88|1.35|0.0004
73966213|NCT02638337|147468666|SUPERIORITY||Odds Ratio (OR)|0.71||||0.4336|TWO_SIDED|95.0|0.3|1.67|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||1.67|0.30|0.4336
73966214|NCT02638337|147468666|SUPERIORITY||Odds Ratio (OR)|0.88||||0.7672|TWO_SIDED|95.0|0.37|2.08|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.08|0.37|0.7672
73915893|NCT00407797|147360708|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Participants with \> 6 seizures during Baseline Period.||||<.0001
73915894|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552|TWO_SIDED|95.0|||||t-test, 2 sided|||Week 21: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0552
73966215|NCT02638337|147468666|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7101|TWO_SIDED|95.0|0.39|1.89|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||1.89|0.39|0.7101
74085969|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.11||0.4784||95.0|-0.3|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.143|-0.300|0.4784
73915895|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED|95.0|||||t-test, 2 sided|||LOCF: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0350
73966216|NCT02638337|147468667|SUPERIORITY||LS Mean Difference|13.98|||<|0.0001|TWO_SIDED|95.0|11.85|16.12|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||16.12|11.85|<0.0001
74085970|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.075||0.2635||95.0|-0.232|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.064|-0.232|0.2635
74085971|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.075||0.6009||95.0|-0.187|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.108|-0.187|0.6009
73915896|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6743|TWO_SIDED||||||t-test, 2 sided|||Week 21: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.6743
74085972|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.073||0.8559||95.0|-0.13|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.156|-0.130|0.8559
74085973|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.074||0.9841||95.0|-0.147|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.144|-0.147|0.9841
73915897|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4736|TWO_SIDED||||||t-test, 2 sided|||LOCF: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.4736
73915898|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8173|TWO_SIDED||||||t-test, 2 sided|||Week 21: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.8173
73915899|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9092|TWO_SIDED||||||t-test, 2 sided|||LOCF: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.9092
73915900|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1091|TWO_SIDED||||||t-test, 2 sided|||Week 21: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1091
73915901|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0944|TWO_SIDED||||||t-test, 2 sided|||LOCF: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0944
73915902|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8928|TWO_SIDED||||||t-test, 2 sided|||Week 21: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.8928
73915903|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7669|TWO_SIDED||||||t-test, 2 sided|||LOCF: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.7669
73966217|NCT02638337|147468667|SUPERIORITY||LS Mean Difference|14.73|||<|0.0001|TWO_SIDED|95.0|12.5|16.96|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||16.96|12.50|<0.0001
73966218|NCT02638337|147468667|SUPERIORITY||LS Mean Difference|14.91|||<|0.0001|TWO_SIDED|95.0|12.55|17.28|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||17.28|12.55|<0.0001
73966219|NCT02638337|147468668|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 4||||<0.0001
73966220|NCT02638337|147468668|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 8||||<0.0001
73915904|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1698|TWO_SIDED||||||t-test, 2 sided|||Week 21: 9-Item Overall Sleep Problems Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1698
73915905|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0898|TWO_SIDED||||||t-test, 2 sided|||LOCF: 9-Item Overall Sleep Problem Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0898
73915906|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0465|TWO_SIDED||||||t-test, 2 sided|||Week 21: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0465
74085974|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.061||0.6771||95.0|-0.095|0.146|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.146|-0.095|0.6771
73966221|NCT02638337|147468668|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 12||||<0.0001
73966222|NCT02638337|147468669|SUPERIORITY||LS Mean Difference|2.5|||<|0.0001|TWO_SIDED|95.0|2.0|3.0|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||3.0|2.0|<0.0001
73966223|NCT02638337|147468669|SUPERIORITY||LS Mean Difference|2.9|||<|0.0001|TWO_SIDED|95.0|2.4|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||3.4|2.4|<0.0001
74085975|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.062||0.3717||95.0|-0.067|0.178|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.178|-0.067|0.3717
74085976|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.058||0.9863||95.0|-0.114|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.116|-0.114|0.9863
73915907|NCT00407797|147360714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0316|TWO_SIDED||||||t-test, 2 sided|||LOCF: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0316
73915908|NCT00407797|147360715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2187|TWO_SIDED|95.0|||||t-test, 2 sided|||Week 21; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.2187
73915909|NCT00407797|147360715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1905|TWO_SIDED|95.0|||||t-test, 2 sided|||LOCF; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1905
73915910|NCT00407797|147360716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Anxiety: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
73915911|NCT00407797|147360716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Anxiety: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
73966224|NCT02638337|147468669|SUPERIORITY||LS Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|2.2|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||3.4|2.2|<0.0001
73966225|NCT02638337|147468670|SUPERIORITY||LS Mean Difference|-0.8||||0.0002|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||-0.4|-1.3|0.0002
73966226|NCT02638337|147468670|SUPERIORITY||LS Mean Difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||-0.6|-1.5|<0.0001
73966227|NCT02638337|147468670|SUPERIORITY||LS Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||-0.7|-1.6|<0.0001
73966228|NCT02638337|147468671|SUPERIORITY||LS Mean Difference|-1.0||||0.0118|TWO_SIDED|95.0|-1.8|-0.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.2|-1.8|0.0118
73915912|NCT00407797|147360716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0799|TWO_SIDED||||||t-test, 2 sided|||Depression: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0799
74027344|NCT03726671|147607767|OTHER|||||||0.2091|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Males||||0.2091
74027345|NCT03726671|147607767|OTHER|||||||0.8141|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Pre-Menopausal Females||||0.8141
74027346|NCT03726671|147607767|OTHER|||||||0.0187|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Post-Menopausal Females||||0.0187
74085977|NCT00442546|147725971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.059||0.0355||95.0|0.009|0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.243|0.009|0.0355
73915913|NCT00407797|147360716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846|TWO_SIDED||||||t-test, 2 sided|||Depression: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0846
73966229|NCT02638337|147468672|SUPERIORITY||LS Mean Difference|0.02||||0.9748|TWO_SIDED|95.0|-1.17|1.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||1.20|-1.17|0.9748
73966230|NCT02638337|147468672|SUPERIORITY||LS Mean Difference|0.19||||0.7865|TWO_SIDED|95.0|-1.18|1.56|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||1.56|-1.18|0.7865
73966231|NCT02638337|147468672|SUPERIORITY||LS Mean Difference|1.59||||0.0392|TWO_SIDED|95.0|0.08|3.09|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||3.09|0.08|0.0392
73966232|NCT02638337|147468673|SUPERIORITY||LS Mean Difference|0.16||||0.0752|TWO_SIDED|95.0|-0.02|0.34|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Desire||0.34|-0.02|0.0752
73966233|NCT02638337|147468673|SUPERIORITY||LS Mean Difference|0.2||||0.1867|TWO_SIDED|95.0|-0.1|0.49|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Arousal||0.49|-0.10|0.1867
73966234|NCT02638337|147468673|SUPERIORITY||LS Mean Difference|0.4||||0.0161|TWO_SIDED|95.0|0.07|0.73|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Lubrication||0.73|0.07|0.0161
73966235|NCT02638337|147468673|SUPERIORITY||LS Mean Difference|0.16||||0.34|TWO_SIDED|95.0|-0.16|0.48|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Orgasm||0.48|-0.16|0.3400
73966236|NCT02638337|147468673|SUPERIORITY||LS Mean Difference|0.16||||0.2195|TWO_SIDED|95.0|-0.1|0.41|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Satisfaction||0.41|-0.10|0.2195
73966237|NCT02638337|147468673|SUPERIORITY||LS Mean Difference|0.45||||0.0103|TWO_SIDED|95.0|0.11|0.8|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Pain||0.80|0.11|0.0103
73966238|NCT02638337|147468674|SUPERIORITY||LS Mean Difference|0.1||||0.723|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||0.6|-0.4|0.7230
73966239|NCT02638337|147468674|SUPERIORITY||LS Mean Difference|0.4||||0.1104|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||0.9|-0.1|0.1104
73966240|NCT02638337|147468674|SUPERIORITY||LS Mean Difference|0.3||||0.2448|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||0.9|-0.2|0.2448
73966241|NCT02638337|147468675|SUPERIORITY||LS Mean Difference|-4388.3||||0.4263|TWO_SIDED|95.0|-15214.8|6438.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||6438.3|-15214.8|0.4263
73966242|NCT02638337|147468676|SUPERIORITY||LS Mean Difference|-0.049|||<|0.0001|TWO_SIDED|95.0|-0.071|-0.027|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.027|-0.071|<0.0001
73966243|NCT02638337|147468677|SUPERIORITY||LS Mean Difference|-0.14||||0.5159|TWO_SIDED|95.0|-0.58|0.29|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||0.29|-0.58|0.5159
73966244|NCT02638337|147468678|SUPERIORITY||LS Mean Difference|-0.75||||0.0227|TWO_SIDED|95.0|-1.39|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.10|-1.39|0.0227
73966245|NCT02638337|147468679|SUPERIORITY||LS Mean Difference|-0.22||||0.0003|TWO_SIDED|95.0|-0.34|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.10|-0.34|0.0003
73966246|NCT02638337|147468680|SUPERIORITY||LS Mean Difference|-6.2|||<|0.0001|TWO_SIDED|95.0|-8.1|-4.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-4.3|-8.1|<0.0001
73966247|NCT02638337|147468681|SUPERIORITY||LS Mean Difference|-1.35||||0.0084|TWO_SIDED|95.0|-2.35|-0.35|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.35|-2.35|0.0084
73966248|NCT02638337|147468682|SUPERIORITY||LS Mean Difference|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.92|-1.19|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-1.19|-2.92|<0.0001
73966249|NCT02638337|147468683|SUPERIORITY||LS Mean Difference|-5.26|||<|0.0001|TWO_SIDED|95.0|-7.64|-2.89|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-2.89|-7.64|<0.0001
73966250|NCT02638337|147468684|SUPERIORITY|||||||0.9575|||||||Welch's t-test|||||||0.9575
73966251|NCT02638337|147468685|SUPERIORITY|||||||0.8772|||||||Welch's t-test|||||||0.8772
73966252|NCT02638337|147468686|SUPERIORITY|||||||0.0007|||||||Wilcoxon rank-sum test|||||||0.0007
73966253|NCT04349072|147468704|SUPERIORITY||Proportion Difference|58.93|||<|0.0001|TWO_SIDED|95.0|43.989|73.868|||Cochran-Mantel-Haenszel|||||73.868|43.989|<0.0001
73966254|NCT04349072|147468705|SUPERIORITY||Proportion Difference|41.07|||<|0.0001|TWO_SIDED|95.0|24.481|57.662|||Cochran-Mantel-Haenszel|||||57.662|24.481|<0.0001
73915914|NCT00601458|147360778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.7||||0.005||97.8|-73.6|-8.0||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (pregabalin - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.|||-8.0|-73.6|0.005
73915915|NCT00601458|147360778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-65.4||||0.0001||97.8|-81.7|-34.6||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (naproxen - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.|||-34.6|-81.7|0.0001
73915916|NCT00601458|147360779|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.46||||0.004||95.0|0.183|2.95||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians|||2.95|0.183|0.004
73915917|NCT00601458|147360779|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.7|||<|0.001||95.0|1.77|6.72||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians|||6.72|1.77|<0.001
73915918|NCT00518986|147360780|SUPERIORITY_OR_OTHER|||||||0.3043||95.0|||||ANCOVA|Study drug was fixed factor and corresponding baseline value was a covariate.||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.||||0.3043
73915919|NCT00518986|147360781|SUPERIORITY_OR_OTHER|||||||0.012|||||||Chi-squared|P-value for comparison is from a Pearson's chi-square test||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.||||0.0120
73915920|NCT00518986|147360782|SUPERIORITY_OR_OTHER|||||||0.0027||||||Nominal p-value is presented, but statistical significance cannot be claimed. As a key secondary variable significance could be claimed only if treatment effect was significant for both primary efficacy variables.|ANCOVA|||Least squares (LS) mean and standard error of the LS mean for each treatment group, and p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline as covariate.||||0.0027
73915921|NCT00518986|147360783|SUPERIORITY_OR_OTHER|||||||0.0019|||||||ANCOVA|||||||0.0019
73915922|NCT00518986|147360784|SUPERIORITY_OR_OTHER|||||||0.3145|||||||ANCOVA|||||||0.3145
73915923|NCT00518986|147360785|SUPERIORITY_OR_OTHER|||||||0.2196|||||||ANCOVA|||||||0.2196
73915924|NCT00518986|147360786|SUPERIORITY_OR_OTHER|||||||0.2017||||||P-value is from Pearson's chi-square test|Chi-squared|||||||0.2017
73915925|NCT00518986|147360787|SUPERIORITY_OR_OTHER|||||||0.0032||||||P-value from Pearson's chi-square test|Chi-squared|||||||0.0032
73915926|NCT00518986|147360788|SUPERIORITY_OR_OTHER|||||||0.0207||||||P-value from Pearson's chi-square test|Chi-squared|||||||0.0207
73915927|NCT00518986|147360789|SUPERIORITY_OR_OTHER|||||||0.0529||||||P-value was generated from a Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||||||0.0529
73915928|NCT00518986|147360790|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Cochran-Mantel-Haenszel|||||||0.0011
73915929|NCT00518986|147360791|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Cochran-Mantel-Haenszel|||||||0.0064
73915930|NCT00518986|147360792|SUPERIORITY_OR_OTHER|||||||0.1072|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1072
73915931|NCT00518986|147360793|SUPERIORITY_OR_OTHER|||||||0.0355|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0355
73915932|NCT00518986|147360794|SUPERIORITY_OR_OTHER|||||||0.0591|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0591
73915933|NCT00518986|147360795|SUPERIORITY_OR_OTHER|||||||0.0025|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0025
73915934|NCT00518986|147360796|SUPERIORITY_OR_OTHER|||||||0.0794||||||P-value for treatment comparison is from Pearson's chi-square test|Chi-squared|||||||0.0794
73915935|NCT00518986|147360797|SUPERIORITY_OR_OTHER|||||||0.0888||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||||||0.0888
73966255|NCT04349072|147468706|SUPERIORITY||Leat Square Mean of Treatment Difference|9.45|||<|0.0001|TWO_SIDED|95.0|4.868|14.041|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||14.041|4.868|<0.0001
73966256|NCT04349072|147468707|SUPERIORITY||Mean Ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.266|0.421|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||0.421|0.266|<0.0001
73966257|NCT04349072|147468708|SUPERIORITY||Mean Ratio|0.53|||<|0.0001|TWO_SIDED|95.0|0.406|0.7|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||0.700|0.406|<0.0001
73966258|NCT04349072|147468709|SUPERIORITY||Leat Square Mean of Treatment Difference|-37.2|||<|0.0001|TWO_SIDED|95.0|-48.08|-26.24|||ANCOVA|||||-26.24|-48.08|<0.0001
73966259|NCT04157348|147468720|SUPERIORITY||Difference in remission rates|0.0121||||0.8773|TWO_SIDED|95.0|-0.1411|0.1653|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||0.1653|-0.1411|0.8773
73966260|NCT04157348|147468721|SUPERIORITY||difference in remission rates|0.0544|||||TWO_SIDED|95.0|-0.0746|0.1834|||Regression, Logistic|marginal standardization method||||0.1834|-0.0746|
74085978|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.202||0.8071||95.0|-0.35|0.449|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.449|-0.350|0.8071
74085979|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.204||0.8282||95.0|-0.359|0.447|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.447|-0.359|0.8282
73915936|NCT00518986|147360798|SUPERIORITY_OR_OTHER|||||||0.0433||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||||||0.0433
73915937|NCT00518986|147360799|SUPERIORITY_OR_OTHER|||||||0.0105||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||||||0.0105
73915938|NCT00518986|147360800|SUPERIORITY_OR_OTHER|||||||0.0523|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0523
73915939|NCT00518986|147360801|SUPERIORITY_OR_OTHER|||||||0.0289|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0289
73915940|NCT00518986|147360802|SUPERIORITY_OR_OTHER|||||||0.1272|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1272
73915941|NCT00518986|147360803|SUPERIORITY_OR_OTHER|||||||0.0349|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0349
73915942|NCT00518986|147360804|SUPERIORITY_OR_OTHER|||||||0.0094|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0094
73915943|NCT00518986|147360805|SUPERIORITY_OR_OTHER|||||||0.0754|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0754
73966261|NCT04157348|147468722|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.72|2.4|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|main remission||2.40|0.72|
73966262|NCT04157348|147468722|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.55|2.29|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|supportive remission||2.29|0.55|
73966263|NCT04157348|147468723|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.74|2.44|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|sustained main remission||2.44|0.74|
74085980|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.192||0.8972||95.0|-0.353|0.403|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.403|-0.353|0.8972
74085981|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.19||0.8159||95.0|-0.329|0.418|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.418|-0.329|0.8159
73915944|NCT00518986|147360806|SUPERIORITY_OR_OTHER|||||||0.0105|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0105
73915945|NCT00518986|147360807|SUPERIORITY_OR_OTHER|||||||0.2888|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2888
73915946|NCT00518986|147360808|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0130
73915947|NCT00518986|147360809|SUPERIORITY_OR_OTHER|||||||0.0354|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0354
73915948|NCT00518986|147360810|SUPERIORITY_OR_OTHER|||||||0.3854||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score \< 7 after baseline||||0.3854
73915949|NCT00518986|147360811|SUPERIORITY_OR_OTHER|||||||0.0145||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders were defined as subjects with worst fatigue score \< 7||||0.0145
73915950|NCT00518986|147360812|SUPERIORITY_OR_OTHER|||||||0.6475||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders were patients with worst fatigue scores \< 7||||0.6475
73915951|NCT00518986|147360813|SUPERIORITY_OR_OTHER|||||||0.0118||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score \< 7||||0.0118
73915952|NCT00518986|147360814|SUPERIORITY_OR_OTHER|||||||0.3483||||||P-value for the treatment comparison is from the Pearson's chi-square test.|Chi-squared|||Responders are subjects with a worst fatigue score of \< 7||||0.3483
73915953|NCT00518986|147360815|SUPERIORITY_OR_OTHER|||||||0.0879|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0879
73915954|NCT00518986|147360816|SUPERIORITY_OR_OTHER|||||||0.0277|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0277
73966264|NCT04157348|147468723|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.64|2.34|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|sustained supportive remission||2.34|0.64|
73966265|NCT04157348|147468724|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.53|1.82|||Regression, Cox||The HR (Benralizumab vs. Mepolizumab) and 95% CI are estimated using a Cox regression model with Efron method to control for ties. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|relapse||1.82|0.53|
73915955|NCT00518986|147360817|SUPERIORITY_OR_OTHER|||||||0.1245|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1245
73915956|NCT00518986|147360818|SUPERIORITY_OR_OTHER|||||||0.0305|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0305
73915957|NCT00518986|147360819|SUPERIORITY_OR_OTHER|||||||0.0129|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0129
73915958|NCT00518986|147360820|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0308
73915959|NCT00518986|147360821|SUPERIORITY_OR_OTHER|||||||0.0679|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0679
73915960|NCT00518986|147360822|SUPERIORITY_OR_OTHER|||||||0.0153|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0153
73915961|NCT00518986|147360823|SUPERIORITY_OR_OTHER|||||||0.0296|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0296
73915962|NCT00518986|147360824|SUPERIORITY_OR_OTHER|||||||0.0107|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0107
73915963|NCT00518986|147360825|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as patients with a total score on FOSQ \> 17.9||||0.0100
73915964|NCT00518986|147360826|SUPERIORITY_OR_OTHER|||||||0.0854||95.0||||P-value for treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score of \> 17.9||||0.0854
73915965|NCT00518986|147360827|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score \> 17.9||||0.0027
73915966|NCT00518986|147360828|SUPERIORITY_OR_OTHER|||||||0.0189||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||Responders are defined as subjects who had a total score of \> 17.9||||0.0189
73915967|NCT00518986|147360829|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with total score \> 17.9||||0.0240
73915968|NCT00518986|147360830|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3320
73966266|NCT04157348|147468725|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.56|1.9|||negative binomial model|marginal standardization method|The rate ratio (Benralizumab/Mepolizumab) and the corresponding 95% CI are calculated using a negative binomial model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|relapse||1.90|0.56|
73966267|NCT04157348|147468727|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.75|2.54|||proportional odds model||The odds ratio (Benralizumab 30 mg vs. Mepolizumab 300 mg) and 95% CI are estimated using a proportional odds model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||2.54|0.75|
73966268|NCT04157348|147468728|SUPERIORITY||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|0.96|3.22|||proportional odds model||The odds ratio (Benralizumab 30 mg vs. Mepolizumab 300 mg) for higher % reduction and 95% CI are estimated using a proportional odds model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||3.22|0.96|
73966269|NCT04157348|147468729|SUPERIORITY||difference in proportions|0.1079|||||TWO_SIDED|95.0|-0.0225|0.2383|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|\>=50% reduction||0.2383|-0.0225|
74027347|NCT03726671|147607767|OTHER|||||||0.0107|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Males||||0.0107
74027348|NCT03726671|147607768|OTHER|||||||0.0842|||||||Mixed Models Analysis|||||||0.0842
74027349|NCT03726671|147607768|OTHER|||||||0.0819|||||||Wilcoxon (Mann-Whitney)|Non-parametric method was used due to data deviation from normality.||||||0.0819
74027350|NCT03726671|147607768|OTHER|||||||0.9015|||||||t-test, 2 sided|||||||0.9015
74027351|NCT03726671|147607768|OTHER|||||||0.1191|||||||Wilcoxon (Mann-Whitney)|Non-parametric method was used due to data deviation from normality.||||||0.1191
74027352|NCT03726671|147607769|OTHER|||||||0.2351|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. betaine IER||||0.2351
74027353|NCT03726671|147607769|OTHER|||||||0.4501|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.4501
73966270|NCT04157348|147468729|SUPERIORITY||difference in proportions|0.1569|||||TWO_SIDED|95.0|0.0067|0.3017|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|100% reduction||0.3017|0.0067|
73966271|NCT04157348|147468729|SUPERIORITY||difference in proportions|-0.0068|||||TWO_SIDED|95.0|-0.1555|0.1418|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|OCS dose \<=4 mg/day||0.1418|-0.1555|
74027354|NCT03726671|147607769|OTHER|||||||0.4136|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.4136
74027355|NCT03726671|147607769|OTHER|||||||0.9463|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Betaine IER||||0.9463
74027356|NCT03726671|147607769|OTHER|||||||0.0675|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.0675
74027357|NCT03726671|147607769|OTHER|||||||0.2863|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.2863
74027358|NCT03726671|147607769|OTHER|||||||0.5552|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Betaine IER||||0.5552
74027359|NCT03726671|147607769|OTHER|||||||0.4209|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.4209
74027360|NCT03726671|147607769|OTHER|||||||0.6647|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.6647
74027361|NCT01709799|147607788|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,90.577)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||< .001
74027362|NCT01709799|147607788|SUPERIORITY_OR_OTHER|||||||0.995|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for statistical significance was 0.05|Mixed Models Analysis|Degrees of freedom are (4,90.564)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.995
74027363|NCT01709799|147607789|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,97.137)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<.001
74027364|NCT01709799|147607789|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,97.108)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.254
74085982|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.188||0.8577||95.0|-0.337|0.405|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.405|-0.337|0.8577
74085983|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.188||0.8158||95.0|-0.415|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.327|-0.415|0.8158
74027365|NCT01709799|147607790|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,99.647)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
74027366|NCT01709799|147607790|SUPERIORITY_OR_OTHER|||||||0.781|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,99.601)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.781
73966272|NCT04157348|147468730|SUPERIORITY||difference in response rates|0.046|||||TWO_SIDED|95.0|-0.0422|0.1341|||Regression, Logistic|marginal standardization method|The difference of response rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|any clinical response-definition 1||0.1341|-0.0422|
74027367|NCT01709799|147607791|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,102.315)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
74027368|NCT01709799|147607791|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,102.216)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.026
74027369|NCT01709799|147607792|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,93.240)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
74027370|NCT01709799|147607792|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,93.167)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.313
74027371|NCT01709799|147607793|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,115.573)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||0.630
74085984|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.195||0.4243||95.0|-0.229|0.541|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.541|-0.229|0.4243
74085985|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.205|STANDARD_ERROR_OF_MEAN|0.187||0.2742||95.0|-0.164|0.574|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.574|-0.164|0.2742
73860087|NCT02214225|147266178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.9|||||TWO_SIDED|95.0|0.84|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.97|0.84|
73860088|NCT02214225|147266178|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|1.03|||||TWO_SIDED|95.0|0.94|1.14||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.14|0.94|
73860089|NCT02214225|147266179|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-2.1|||||TWO_SIDED|95.0|-6.9|2.6||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||2.6|-6.9|
73860090|NCT02214225|147266179|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-4.6|||||TWO_SIDED|95.0|-9.3|0.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||0.2|-9.3|
73860091|NCT02214225|147266179|NON_INFERIORITY_OR_EQUIVALENCE|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-4.5|||||TWO_SIDED|95.0|-10.3|1.3||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||1.3|-10.3|
73860092|NCT02214225|147266179|NON_INFERIORITY_OR_EQUIVALENCE|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-4.6|||||TWO_SIDED|95.0|-10.5|1.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||1.2|-10.5|
73860093|NCT02214225|147266179|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-0.2|||||TWO_SIDED|95.0|-4.4|4.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||4.0|-4.4|
73860094|NCT02214225|147266179|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|1.1|||||TWO_SIDED|95.0|-3.1|5.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||5.2|-3.1|
73915969|NCT00518986|147360831|SUPERIORITY_OR_OTHER|||||||0.893||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8930
73966273|NCT04157348|147468730|SUPERIORITY||difference in response rates|0.079|||||TWO_SIDED|95.0|-0.0732|0.2312|||Regression, Logistic|marginal standardization method|The difference of response rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|complete response-definition 1||0.2312|-0.0732|
73860095|NCT02214225|147266179|NON_INFERIORITY_OR_EQUIVALENCE|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-2.2|||||TWO_SIDED|95.0|-6.3|2.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||2.0|-6.3|
73860096|NCT02214225|147266179|NON_INFERIORITY_OR_EQUIVALENCE|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|1.2|||||TWO_SIDED|95.0|-3.7|6.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||6.2|-3.7|
73860097|NCT02214225|147266180|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) overall|1.47|||||TWO_SIDED|95.0|1.38|1.57|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.57|1.38|
73915970|NCT00518986|147360832|SUPERIORITY_OR_OTHER|||||||0.1774||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1774
73915971|NCT00518986|147360833|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1000
73860098|NCT02214225|147266180|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) overall|1.57|||||TWO_SIDED|95.0|1.45|1.7|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.70|1.45|
73915972|NCT00518986|147360834|SUPERIORITY_OR_OTHER|||||||0.2428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2428
73915973|NCT00518986|147360835|SUPERIORITY_OR_OTHER|||||||0.1816||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1816
73915974|NCT00518986|147360836|SUPERIORITY_OR_OTHER|||||||0.1627||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1627
73915975|NCT00518986|147360837|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0018
73915976|NCT00518986|147360838|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0096
73915977|NCT00518986|147360839|SUPERIORITY_OR_OTHER|||||||0.0126||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0126
73915978|NCT01146418|147360876|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|-1.8|||||TWO_SIDED|95.0|-6.5|3.0|||Clopper-Pearson method|Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \>38 yrs)||||3.0|-6.5|
73915979|NCT01146418|147360877|SUPERIORITY_OR_OTHER_LEGACY||Estimated difference|-1.2|||||TWO_SIDED|95.0|-5.7|3.4|||Clopper-Pearson method|Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \>38 yrs)||||3.4|-5.7|
73915980|NCT03789474|147360878|SUPERIORITY|||||||0.443|||||||t-test, 2 sided|||||||.443
73915981|NCT03789474|147360879|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||.063
73915982|NCT03789474|147360880|SUPERIORITY|||||||0.057|||||||t-test, 2 sided|||||||.057
73915983|NCT03789474|147360881|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||||||.038
73915984|NCT03789474|147360882|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||.072
73915985|NCT03789474|147360883|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||.189
73915986|NCT03789474|147360884|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||||||.358
73915987|NCT03789474|147360885|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||||||.406
73915988|NCT03789474|147360886|SUPERIORITY|||||||0.256|||||||t-test, 2 sided|||||||.256
73915989|NCT03789474|147360887|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||.066
73915990|NCT03789474|147360888|SUPERIORITY|||||||0.316|||||||t-test, 2 sided|||||||.316
73915991|NCT03789474|147360889|SUPERIORITY|||||||0.971|||||||t-test, 2 sided|||||||.971
73966274|NCT04157348|147468731|SUPERIORITY||difference in remission rates|0.0554|||||TWO_SIDED|95.0|-0.093|0.2037|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|main remission||0.2037|-0.0930|
73915992|NCT03789474|147360890|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.030
73915993|NCT03789474|147360891|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||.009
73915994|NCT03789474|147360892|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||||||.704
73915995|NCT03789474|147360893|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.350
73915996|NCT03789474|147360894|SUPERIORITY|||||||0.708|||||||t-test, 2 sided|||||||.708
73915997|NCT03789474|147360895|SUPERIORITY|||||||0.711|||||||t-test, 2 sided|||||||.711
73915998|NCT03789474|147360896|SUPERIORITY|||||||0.956|||||||t-test, 2 sided|||||||.956
73915999|NCT03789474|147360897|SUPERIORITY|||||||0.139|||||||t-test, 2 sided|||||||.139
73916000|NCT03789474|147360898|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||.035
73916001|NCT03789474|147360899|SUPERIORITY|||||||0.502|||||||t-test, 2 sided|||||||.502
73916002|NCT03789474|147360900|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.350
73916003|NCT03789474|147360901|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||.380
73916004|NCT03789474|147360902|SUPERIORITY|||||||0.914|||||||t-test, 2 sided|||||||.914
73916005|NCT03789474|147360903|SUPERIORITY|||||||0.915|||||||t-test, 2 sided|||||||.915
73916006|NCT03789474|147360904|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||.087
73916007|NCT03789474|147360905|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||.011
73916008|NCT03789474|147360906|SUPERIORITY|||||||0.207|||||||t-test, 2 sided|||||||.207
73916009|NCT03789474|147360907|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||||||.142
73916010|NCT03789474|147360908|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|||||||.021
73916011|NCT03789474|147360909|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
73916012|NCT03789474|147360910|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.030
73916013|NCT03789474|147360911|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||||||.048
73916014|NCT03789474|147360912|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
73916015|NCT03789474|147360913|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||.019
74085986|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.069|STANDARD_ERROR_OF_MEAN|0.116||0.5569||95.0|-0.302|0.165|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.165|-0.302|0.5569
74085987|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.116||0.3762||95.0|-0.13|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.336|-0.130|0.3762
74085988|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.155||0.6203||95.0|-0.229|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.383|-0.229|0.6203
73916016|NCT03789474|147360914|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
73916017|NCT03789474|147360915|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
73916018|NCT03789474|147360916|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.020
73916019|NCT03789474|147360917|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
73916020|NCT03789474|147360918|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||.053
73916021|NCT03789474|147360919|SUPERIORITY|||||||0.746|||||||t-test, 2 sided|||||||.746
73916022|NCT03789474|147360920|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
73916023|NCT03789474|147360921|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
73916024|NCT03789474|147360922|SUPERIORITY|||||||0.043|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.043
73916025|NCT03789474|147360923|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||.160
73916026|NCT01269463|147360965|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
73916027|NCT01269463|147360966|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
73916028|NCT04404361|147360976|SUPERIORITY||Risk Difference (RD)|1.51||||0.8516|TWO_SIDED|95.0|-10.55|13.53|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5).||||13.53|-10.55|0.8516
73916029|NCT04404361|147360977|SUPERIORITY|||||||0.7494|||||||Wilcoxon (Mann-Whitney)|||||||0.7494
73916030|NCT04404361|147360978|SUPERIORITY||Odds Ratio (OR)|1.29||||0.6323|TWO_SIDED|95.0|0.46|3.58|||Cochran-Mantel-Haenszel||OR from a CMH test stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS|||3.58|0.46|0.6323
73966275|NCT04157348|147468731|SUPERIORITY||difference in remission rates|0.0467|||||TWO_SIDED|95.0|-0.1021|0.1956|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|supportive remission||0.1956|-0.1021|
73966276|NCT04757610|147468752|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.023||0.284421|TWO_SIDED|95.0|-3.1|0.91|||MMRM|||||0.91|-3.10|0.284421
73966277|NCT04757610|147468752|SUPERIORITY||Least Squares Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|1.025||0.066678|TWO_SIDED|95.0|-3.9|0.13|||MMRM|||||0.13|-3.90|0.066678
73971314|NCT03785964|147483160|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 27 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||0.006
73971315|NCT03785964|147483161|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
73971316|NCT03785964|147483162|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
73971317|NCT04117347|147483168|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.022|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.0861723|0.1309519|||||coefficient for an indicator for Light Therapy B (vs. Light Therapy A)|Analysis for left amygdala.||0.1309519|-0.0861723|
73971318|NCT04117347|147483168|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.068|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.0363877|0.1730965|||||coefficient for an indicator for Light Therapy C (vs. Light Therapy A)|Analysis for left amygdala.||0.1730965|-0.0363877|
73916031|NCT04404361|147360979|SUPERIORITY||Odds Ratio (OR)|1.25||||0.7541|TWO_SIDED|95.0|0.31|4.96|||Cochran-Mantel-Haenszel||OR from a CMH test Stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS|||4.96|0.31|0.7541
73916032|NCT04404361|147360980|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.5666|TWO_SIDED|95.0|0.79|1.53||"log-rank test stratified by randomization stratification factors age (\<60 years versus~≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS"|Log Rank|"stratified by randomization stratification factors age (\<60 years versus~≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)"|estimated using a stratified Cox proportional hazards model stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)|||1.53|0.79|0.5666
73916033|NCT04404361|147360982|SUPERIORITY||Odds Ratio (OR)|2.46||||0.2722|TWO_SIDED|95.0|0.47|12.93|||Chi-squared|||||12.93|0.47|0.2722
74027372|NCT01709799|147607793|SUPERIORITY_OR_OTHER|||||||0.498|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,115.593)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.498
73916034|NCT01125605|147360988|SUPERIORITY_OR_OTHER|||||||0.0033||95.0|||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit 1) and last observation was exploratively analysed||||0.0033
73916035|NCT01125605|147360988|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit1) and last observation by duration of treatment||||0.0002
73916036|NCT01125605|147360989|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Fisher Exact|||||||0.0014
73916037|NCT01125605|147360990|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||Fisher Exact|||||||0.0125
73916038|NCT01125605|147360991|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Fisher Exact|||||||0.0006
73916039|NCT01125605|147360992|SUPERIORITY_OR_OTHER|||||||0.0016||95.0|||||Fisher Exact|||||||0.0016
73916040|NCT01125605|147360993|SUPERIORITY_OR_OTHER|||||||0.0504||95.0|||||Fisher Exact|||||||0.0504
73916041|NCT01125605|147360995|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Fisher Exact|||||||0.0002
73916042|NCT02674529|147361057|OTHER|This was a mechanistic trial and non-inferiority or equivalence analysis were not performed.|regression coefficient|-1.29864|STANDARD_ERROR_OF_MEAN|2.3||0.58|TWO_SIDED|95.0|||||Regression, Linear|Drug (antidepressant vs. placebo) prediction of changes in mood as measured by the MADRS scores.||||||0.58
73916043|NCT02674529|147361057|OTHER||r|0.02||||0.05|TWO_SIDED||||||Correlation|Change in MADRS after 8 weeks correlation with brain responses during the baseline fMRI task.||||||0.05
73916044|NCT02674529|147361058|OTHER|This is a mechanistic trial, we did not perform non-inferiority or equivalence analysis.|regression coefficient|-1.4328918|STANDARD_DEVIATION|1.4||0.8|TWO_SIDED|95.0|||||Regression, Linear|||||||0.8
73916045|NCT02674529|147361059|OTHER||||||<|0.05||||||The resulting voxel-wise parametric maps are thresholded with height and extent values generated by Monte Carlo simulations with 3dClustSim to protect against overall type I error at p \< 0.05.|t-test, 2 sided|||At the group-level, a random-effects analysis determines the main effects of the regressors of interest (e.g., high vs. low expectancy) resulting in statistical parametric maps (t or F statistics). To control for potential confounders, sex and depression severity will be entered as covariates in statistical models.||||<0.05
73916046|NCT02891850|147361060|EQUIVALENCE|The hypothesis was that there was no difference in the satisfactory clinical response rates in terms of odds ratio (OR) when treated with riociguat compared with participants who remained on their previous therapy.|Odds Ratio (OR)|2.78||||0.0007|TWO_SIDED|95.0|1.526|5.06|||Mantel Haenszel|Stratified by PAH category at baseline||||5.060|1.526|0.0007
73916047|NCT02891850|147361061|EQUIVALENCE|The hypothesis was that there was no difference in the change of 6MWD in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|22.56||||0.0542|TWO_SIDED|95.0|5.03|40.1|||t-test, 2 sided|Stratified by PAH category at baseline||||40.10|5.03|0.0542
73916048|NCT02891850|147361062|EQUIVALENCE|The hypothesis was that there was no difference in the change of NT-proBNP in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|-169.65||||0.1067|TWO_SIDED|95.0|-426.18|86.88|||t-test, 2 sided|Stratified by PAH category at baseline||||86.88|-426.18|0.1067
73916049|NCT02891850|147361063|EQUIVALENCE|The hypothesis was that there was no difference in the change from baseline in WHO FC in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|-0.26||||0.0007|TWO_SIDED|95.0|-0.42|-0.11|||t-test, 2 sided|Stratified by PAH category at baseline||||-0.11|-0.42|0.0007
73916050|NCT02891850|147361064|EQUIVALENCE|The hypothesis was that there was no difference in the clinical worsening rates in terms of odds ratio (OR) when treated with riociguat compared with participants who remained on their previous therapy.|Odds Ratio (OR)|0.1||||0.0047|TWO_SIDED|95.0|0.013|0.725|||Mantel Haenszel|Stratified by PAH category at baseline||||0.725|0.013|0.0047
73916051|NCT04617509|147361068|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on Cmax ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric means|1.4514|||||TWO_SIDED|90.0|1.111|1.4514||||||Relative bioavailability (A versus B)||1.4514|1.1110|
73916052|NCT04617509|147361068|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on Cmax ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.5497|||||TWO_SIDED|90.0|0.3977|0.7597||||||Relative bioavailability (A FED versus A FASTED)||0.7597|0.3977|
73966278|NCT04924062|147468777|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.51|1.08|||||HR=Arm A/Arm B|||1.08|0.51|
73966279|NCT04924062|147468778|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.58|1.19|||||HR=Arm A/Arm B|||1.19|0.58|
73966280|NCT04924062|147468779|OTHER||Difference in Percentages|7.1|||||TWO_SIDED|95.0|-7.5|21.6|||||Difference=Arm A minus Arm B|||21.6|-7.5|
74027373|NCT02767570|147607806|SUPERIORITY||Mean Difference (Net)|-1.2||||0.001|TWO_SIDED|95.0|-1.9|-0.5||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|For the primary hypothesis that there would be a greater reduction in pain for the altered compared to the consistent FPA group, an effect size of 0.57 was assumed. To achieve 80% power with an alpha of 0.05, 39 participants per group were needed, so our recruitment goal was 40 subjects per group.||-0.5|-1.9|0.001
74027374|NCT02767570|147607807|SUPERIORITY||Mean Difference (Net)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.13||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||-0.13|-0.39|<0.001
73966281|NCT02396199|147468806|SUPERIORITY||Proportion of participants|0.917||||0.006|ONE_SIDED|95.0|0.827|||One-sided test|Fisher Exact||Exact test, One-sided 95%, with lower limit (0.827)||||0.827|0.006
73966282|NCT02721381|147468810|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||<.001
73916053|NCT04617509|147361069|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on AUC0-inf ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|1.3441|||||TWO_SIDED|90.0|1.0953|1.6495||||||Relative bioavailability (A versus B)||1.6495|1.0953|
73916054|NCT04617509|147361069|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on AUC0-inf ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.7327|||||TWO_SIDED|90.0|0.591|0.9083||||||Relative bioavailability (A FED versus A FASTED)||0.9083|0.5910|
73916055|NCT04617509|147361070|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on AUC0-24h ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|1.371|||||TWO_SIDED|90.0|1.112|1.6904||||||Relative bioavailability (A versus B)||1.6904|1.1120|
73916056|NCT04617509|147361070|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on AUC0-24h ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.7083|||||TWO_SIDED|90.0|0.5728|0.8759||||||Relative bioavailability (A FED versus A FASTED)||0.8759|0.5728|
73916057|NCT00903695|147361081|SUPERIORITY_OR_OTHER|||||||0.8133||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio = 0.06, t-test = -0.25."||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.8133
73916058|NCT00903695|147361082|SUPERIORITY_OR_OTHER|||||||0.31||||||a priori threshold for statistical sginficance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio=1.22, t-test=1.1"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.31
73916059|NCT00903695|147361083|SUPERIORITY_OR_OTHER|||||||0.27||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.5, t-test = -1.23"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.27
73916060|NCT00903695|147361084|SUPERIORITY_OR_OTHER|||||||0.24||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.7, t-test = 1.3"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.24
73916061|NCT00903695|147361085|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 0.15, t-test = 0.39"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.71
73916062|NCT00903695|147361086|SUPERIORITY_OR_OTHER|||||||0.18||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 2.25, ttest = -1.5"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.18
73966283|NCT02721381|147468811|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||<.001
73966284|NCT02721381|147468812|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.85
73966285|NCT02721381|147468813|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.85
73916063|NCT00903695|147361087|SUPERIORITY_OR_OTHER|||||||0.34||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.06, t-test = -1.03"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.34
73916064|NCT00543140|147361088|SUPERIORITY_OR_OTHER|||||||0.6919|TWO_SIDED|||||No adjustments for multiple comparisons were performed as only one hypothesis was tested in this study. The level of significance was set at 0.05.|Exact Binomial method|||The primary analysis used a one-sided binomial exact test method by Clopper and Pearson to determine if the rate of reoperations observed in Years 4 and 5 (combined) of the study was significantly less than 8%. The null hypothesis was that the reoperation rate was greater than or equal to 8%.||||0.6919
73916065|NCT02270957|147361145|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
73916066|NCT02270957|147361146|SUPERIORITY|||||||0.587|||||||Chi-squared|||||||0.587
73916067|NCT02270957|147361147|SUPERIORITY|||||||0.587|TWO_SIDED|95.0||||None of the endpoints were met in any pre-specified unbiased Full Analysis Set analysis|Chi-squared|||||||0.587
73916068|NCT00919724|147361148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|0.6||0.1||||||Comparison between HIV-infected and HIV-uninfected groups. Comparison adjusted for age, gender, race, height, and brachial artery baseline diameter.|Regression, Linear|||||||0.10
73916069|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.473|||||TWO_SIDED|95.0|-15.7096|26.6553|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein A1||26.6553|-15.7096|
73916070|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.598|||||TWO_SIDED|95.0|-21.784|20.5888|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein A1||20.5888|-21.7840|
73916071|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.906|||||TWO_SIDED|95.0|-9.3489|33.1602|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1||33.1602|-9.3489|
73916072|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.671|||||TWO_SIDED|95.0|-16.9957|24.3384|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein A1||24.3384|-16.9957|
73966286|NCT02721381|147468814|SUPERIORITY|||||||0.98|||||||ANCOVA|||||||.98
73966287|NCT02721381|147468815|SUPERIORITY|||||||0.69|||||||ANCOVA|||||||.69
74027375|NCT02767570|147607808|SUPERIORITY||Mean Difference (Net)|-3.74||||0.006|TWO_SIDED|95.0|-6.42|-1.05||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||-1.05|-6.42|0.006
74027376|NCT02767570|147607809|SUPERIORITY||Mean Difference (Net)|-0.06||||0.93|TWO_SIDED|95.0|-1.42|1.3||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||1.30|-1.42|0.93
74027377|NCT02767570|147607810|SUPERIORITY||Mean Difference (Net)|-0.29||||0.85|TWO_SIDED|95.0|-3.38|2.8||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||2.80|-3.38|0.85
74027378|NCT02767570|147607811|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-0.89|0.9||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||0.90|-0.89|0.99
74027379|NCT00151411|147607812|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.54|TWO_SIDED|95.0|-9.9|18.4|||Mixed Models Analysis|||||18.4|-9.9|0.54
74027380|NCT00151411|147607813|SUPERIORITY||Rate Ratio|2.5||||0.07|TWO_SIDED|95.0|0.9|6.6|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the probability of ovulation.||6.6|0.9|0.07
74027381|NCT00151411|147607813|SUPERIORITY||rate ratio|1.2||||0.51|TWO_SIDED|95.0|0.7|1.9|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the count of ovulations provided a woman actually ovulated.||1.9|0.7|0.51
74027382|NCT00151411|147607814|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.05|TWO_SIDED|95.0|0.1|9.0|||Mixed Models Analysis|||||9.0|0.1|0.05
74027383|NCT00417612|147607815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED||||||ANOVA|||||||0.007
74027384|NCT01819935|147607834|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.72|1.2||||||Propensity Cox proportional hazards regression model was used.||1.20|0.72|
74027385|NCT01819935|147607835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.53|1.05||||||Propensity Cox proportional hazards regression model was used.||1.05|0.53|
74027386|NCT01819935|147607836|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.9|1.15||||||Propensity Cox proportional hazards regression model was used.||1.15|0.90|
74027387|NCT01819935|147607837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.39|1.09||||||Propensity Cox proportional hazards regression model was used.||1.09|0.39|
74027388|NCT01819935|147607838|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.68|1.37||||||Propensity Cox proportional hazards regression model was used.||1.37|0.68|
74085989|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.155||0.3343||95.0|-0.155|0.455|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.455|-0.155|0.3343
73916073|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.618|||||TWO_SIDED|95.0|-28.2069|37.4425|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1||37.4425|-28.2069|
74027389|NCT01819935|147607839|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.68|1.13||||||Propensity Cox proportional hazards regression model was used.||1.13|0.68|
74027390|NCT01819935|147607840|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.48||||||Propensity Cox proportional hazards regression model was used.||1.48|0.54|
74027391|NCT01819935|147607841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|1.06|1.45||||||Propensity Cox proportional hazards regression model was used.||1.45|1.06|
74027392|NCT01157169|147607842|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.49|||||TWO_SIDED|90.0|101.67|120.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120.07|101.67|
74027393|NCT01157169|147607843|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.91|||||TWO_SIDED|90.0|99.74|112.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.45|99.74|
74027394|NCT01157169|147607844|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.97|||||TWO_SIDED|90.0|97.18|111.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.24|97.18|
74085990|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.128||0.2213||95.0|-0.096|0.41|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.410|-0.096|0.2213
73916074|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.713|||||TWO_SIDED|95.0|-17.0405|39.8527|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein A1||39.8527|-17.0405|
73916075|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.934|||||TWO_SIDED|95.0|-21.0153|31.5504|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein A1||31.5504|-21.0153|
73916076|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.466|||||TWO_SIDED|95.0|-23.7517|24.7608|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein A1||24.7608|-23.7517|
73916077|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.743|||||TWO_SIDED|95.0|-3.246|33.7161|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein B100||33.7161|-3.2460|
73916078|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.428|||||TWO_SIDED|95.0|-21.3243|8.9224|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein B100||8.9224|-21.3243|
74085991|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.131||0.2863||95.0|-0.118|0.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.399|-0.118|0.2863
74085992|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.082||0.305||95.0|-0.077|0.245|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.245|-0.077|0.3050
73916079|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.96|||||TWO_SIDED|95.0|-26.8137|1.1513|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100||1.1513|-26.8137|
74085993|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.083||0.0155||95.0|0.039|0.368|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.368|0.039|0.0155
74085994|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.087||0.9243||95.0|-0.164|0.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.181|-0.164|0.9243
74085995|NCT00442546|147725972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.089||0.0201||95.0|0.033|0.386|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.386|0.033|0.0201
74085996|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.321||0.1537||95.0|-1.093|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.173|-1.093|0.1537
73916080|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.903|||||TWO_SIDED|95.0|-16.6557|13.1191|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein B100||13.1191|-16.6557|
73916081|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.231|||||TWO_SIDED|95.0|-45.1045|-11.3579|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100||-11.3579|-45.1045|
73916082|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|||||TWO_SIDED|95.0|-23.5021|11.3014|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein B100||11.3014|-23.5021|
73966288|NCT02721381|147468816|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.038
73966289|NCT02721381|147468817|SUPERIORITY|||||||0.45|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.45
73966290|NCT02721381|147468818|SUPERIORITY|||||||0.92|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.92
74085997|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.398|STANDARD_ERROR_OF_MEAN|0.324||0.2208||95.0|-1.038|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.241|-1.038|0.2208
74085998|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.325||0.8355||95.0|-0.707|0.572|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.572|-0.707|0.8355
74085999|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.331||0.5024||95.0|-0.875|0.43|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.430|-0.875|0.5024
74086000|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.282||0.8116||95.0|-0.489|0.624|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.624|-0.489|0.8116
73916083|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.49|||||TWO_SIDED|95.0|-25.2721|8.2918|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein B100||8.2918|-25.2721|
73916084|NCT01218204|147361187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.687|||||TWO_SIDED|95.0|-26.0247|6.6498|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein B100||6.6498|-26.0247|
73916085|NCT01218204|147361188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.471|||||TWO_SIDED|95.0|-47.9323|3.202|||||Statistical analysis was performed using LS mean value Atorvastatin|||3.2020|-47.9323|
73916086|NCT01218204|147361188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.91|||||TWO_SIDED|95.0|-38.1027|25.3126|||||Statistical analysis was performed using LS mean value Atorvastatin|||25.3126|-38.1027|
73916087|NCT01218204|147361188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.985|||||TWO_SIDED|95.0|-45.5492|1.8605|||||Statistical analysis was performed using LS mean value Atorvastatin|||1.8605|-45.5492|
73916088|NCT01218204|147361188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.697|||||TWO_SIDED|95.0|-45.0846|13.3024|||||Statistical analysis was performed using LS mean value Atorvastatin|||13.3024|-45.0846|
73916089|NCT01218204|147361188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.036|||||TWO_SIDED|95.0|-27.2281|15.1569|||||Statistical analysis was performed using LS mean value of Atorvastatin|||15.1569|-27.2281|
73916090|NCT01218204|147361188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.198|||||TWO_SIDED|95.0|-24.2901|32.6057|||||Statistical analysis was performed using LS mean value of GSK1292263|||32.6057|-24.2901|
73916091|NCT01218204|147361188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.117|||||TWO_SIDED|95.0|-40.4767|1.906|||||Statistical analysis was performed using LS mean value of GSK1292263|||1.9060|-40.4767|
73916092|NCT01218204|147361188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.798|||||TWO_SIDED|95.0|-48.3842|-12.5064|||||Statistical analysis was performed using LS mean value of GSK1292263|||-12.5064|-48.3842|
73966291|NCT02721381|147468819|SUPERIORITY|||||||0.42|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.42
73966292|NCT02721381|147468820|SUPERIORITY|||||||0.65|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.65
73966293|NCT02721381|147468821|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Independent samples t-test||||.001
73916093|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.101|||||TWO_SIDED|95.0|-4.5469|14.7495|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||14.7495|-4.5469|
73916094|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.273|||||TWO_SIDED|95.0|2.5937|21.9532|||||Statistical analysis was performed using LS mean value of Atorvastatin|Fo HDLc||21.9532|2.5937|
73916095|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.833|||||TWO_SIDED|95.0|18.955|38.7102|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||38.7102|18.9550|
73916096|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.701|||||TWO_SIDED|95.0|-5.5562|12.9578|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||12.9578|-5.5562|
73916097|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.946|||||TWO_SIDED|95.0|8.612|33.281|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||33.2810|8.6120|
73916098|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.561|||||TWO_SIDED|95.0|-0.9675|22.0898|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||22.0898|-0.9675|
73916099|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.122|||||TWO_SIDED|95.0|-0.2902|22.5351|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||22.5351|-0.2902|
73916100|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.689|||||TWO_SIDED|95.0|9.7527|31.6262|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||31.6262|9.7527|
73916101|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.549|||||TWO_SIDED|95.0|-18.775|9.6768|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||9.6768|-18.7750|
73916102|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.337|||||TWO_SIDED|95.0|-24.4549|3.7803|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||3.7803|-24.4549|
74027395|NCT01157169|147607845|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.28|||||TWO_SIDED|90.0|85.37|101.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.93|85.37|
73916103|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.317|||||TWO_SIDED|95.0|-36.0144|-6.619|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-6.6190|-36.0144|
73916104|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.173|||||TWO_SIDED|95.0|-34.271|-6.0755|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-6.0755|-34.2710|
73916105|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.472|||||TWO_SIDED|95.0|-49.3385|-8.1558|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-8.1558|-49.3385|
73916106|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.128|||||TWO_SIDED|95.0|-23.3049|-0.9514|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-0.9514|-23.3049|
73916107|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.798|||||TWO_SIDED|95.0|-27.1364|-4.4589|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-4.4589|-27.1364|
73916108|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.789|||||TWO_SIDED|95.0|-32.3413|-11.2372|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-11.2372|-32.3413|
73916109|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.498|||||TWO_SIDED|95.0|-38.446|-2.4169|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-2.4169|-38.4460|
73916110|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.781|||||TWO_SIDED|95.0|-39.1603|-4.513|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-4.5130|-39.1603|
73916111|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-39.923|||||TWO_SIDED|95.0|-52.3394|-24.2717|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-24.2717|-52.3394|
73916112|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.444|||||TWO_SIDED|95.0|-33.502|2.491|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||2.4910|-33.5020|
73916113|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.781|||||TWO_SIDED|95.0|-40.296|-3.2667|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-3.2667|-40.2960|
73916114|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.421|||||TWO_SIDED|95.0|-38.3519|-4.4911|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-4.4911|-38.3519|
73916115|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.361|||||TWO_SIDED|95.0|-63.465|-29.2561|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-29.2561|-63.4650|
73916116|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.843|||||TWO_SIDED|95.0|-70.7854|-38.9007|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-38.9007|-70.7854|
73916117|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.756|||||TWO_SIDED|95.0|-21.7561|2.2448|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||2.2448|-21.7561|
73916118|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.014|||||TWO_SIDED|95.0|-25.7497|-2.2787|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-2.2787|-25.7497|
73916119|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.675|||||TWO_SIDED|95.0|-39.8454|-15.5045|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-15.5045|-39.8454|
73916120|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.937|||||TWO_SIDED|95.0|-32.6057|-9.269|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-9.2690|-32.6057|
73916121|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.702|||||TWO_SIDED|95.0|-29.0346|-14.3696|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-14.3696|-29.0346|
73916122|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.18|||||TWO_SIDED|95.0|-23.0636|-3.2961|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-3.2961|-23.0636|
73916123|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.151|||||TWO_SIDED|95.0|-31.942|-12.3605|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-12.3605|-31.9420|
73916124|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.948|||||TWO_SIDED|95.0|-36.2874|-17.6092|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-17.6092|-36.2874|
73916125|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.904|||||TWO_SIDED|95.0|-11.8484|4.04|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||4.0400|-11.8484|
73916126|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.437|||||TWO_SIDED|95.0|-14.346|1.4722|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||1.4722|-14.3460|
73916127|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.294|||||TWO_SIDED|95.0|-18.3923|-2.196|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-2.1960|-18.3923|
73916128|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.065|||||TWO_SIDED|95.0|-19.7688|-4.3609|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-4.3609|-19.7688|
73916129|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.941|||||TWO_SIDED|95.0|-13.9778|-1.9039|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-1.9039|-13.9778|
73916130|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.384|||||TWO_SIDED|95.0|-15.9023|-0.866|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol||-0.8660|-15.9023|
73916131|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.7|||||TWO_SIDED|95.0|-23.1404|-8.2592|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol||-8.2592|-23.1404|
73916132|NCT01218204|147361189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.728|||||TWO_SIDED|95.0|-23.8395|-9.6161||||||For Cholesterol||-9.6161|-23.8395|
73916133|NCT01218204|147361190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.123|||||TWO_SIDED|95.0|-26.6276|2.3814|||||Statistical analysis was performed using LS mean value of Atorvastatin|||2.3814|-26.6276|
73916134|NCT01218204|147361190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.63|||||TWO_SIDED|95.0|-35.9419|-7.3181|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-7.3181|-35.9419|
73916135|NCT01218204|147361190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-41.506|||||TWO_SIDED|95.0|-56.3924|-26.6205|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-26.6205|-56.3924|
73916136|NCT01218204|147361190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.041|||||TWO_SIDED|95.0|-42.2554|-13.8263|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-13.8263|-42.2554|
73916137|NCT01218204|147361190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.293|||||TWO_SIDED|95.0|-51.5654|-12.4042|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-12.4042|-51.5654|
73916138|NCT01218204|147361190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.042|||||TWO_SIDED|95.0|-34.8358|-5.2472|||||Statistical analysis was performed using LS mean value of GSK1292263|||-5.2472|-34.8358|
73916139|NCT01218204|147361190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.903|||||TWO_SIDED|95.0|-36.6155|-7.1913|||||Statistical analysis was performed using LS mean value of GSK1292263|||-7.1913|-36.6155|
73916140|NCT01218204|147361190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.735|||||TWO_SIDED|95.0|-49.722|-21.7485|||||Statistical analysis was performed using LS mean value of GSK1292263|||-21.7485|-49.7220|
73916141|NCT01218204|147361191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.409|||||TWO_SIDED|95.0|-1.0123|0.1942|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.1942|-1.0123|
73916142|NCT01218204|147361191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.296|||||TWO_SIDED|95.0|-0.9063|0.3141|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.3141|-0.9063|
73916143|NCT01218204|147361191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.811|||||TWO_SIDED|95.0|-1.4125|-0.2098|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-0.2098|-1.4125|
73916144|NCT01218204|147361191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.422|||||TWO_SIDED|95.0|-0.9831|0.1394|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.1394|-0.9831|
73916145|NCT01218204|147361191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.384|||||TWO_SIDED|95.0|-0.6009|-0.1669|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-0.1669|-0.6009|
73916146|NCT01218204|147361191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.648|||||TWO_SIDED|95.0|-1.1657|-0.1302|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.1302|-1.1657|
73916147|NCT01218204|147361191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.782|||||TWO_SIDED|95.0|-1.2804|-0.2844|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.2844|-1.2804|
73916148|NCT01218204|147361191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.884|||||TWO_SIDED|95.0|-1.3652|-0.4026|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.4026|-1.3652|
73916149|NCT00489541|147361210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.3|||t-test, 2 sided|||A superiority test of TAXUX Element vs bare metal (BMS) Express historical control. The null hypothesis that the true difference in means (TAXUS Element - BMS Express) is equal to zero was tested against the two-sided alternative that the true difference in means is different from zero. A sample size of 224 patients in the TAXUS Element group (190 after 15% attrition due to angiographic follow-up) provided 85% power.||-0.30|-0.54|<0.0001
73916150|NCT00489541|147361211|SUPERIORITY_OR_OTHER||12-month TLR rate|7.34|||<|0.0001|ONE_SIDED|95.0||10.8|||Chi-squared|||One-sided, single-sample binomial test to compare the observed TLF rate in PERSEUS SV to the pre-specified performance goal (19.5%). The normal approximation of the test statistic was used. The null hypothesis that the true TAXUS Element TLF rate is greater than or equal to the performance goal was tested against the one-sided alternative that the true rate is less than the performance goal. A sample size of 224 patients (accounting for 5% attrition to follow-up) provided 80% power.||10.8||<0.0001
73916151|NCT03266107|147361219|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73916152|NCT03266107|147361220|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73916153|NCT03266107|147361223|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73916154|NCT01191801|147361275|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.0305|ONE_SIDED|95.0||||Unstratified one sided P-Value|Unstratified Log Rank|Since the sample size was increased, the primary analysis used the weighted statistic proposed by Cui, Hung, and Wang (Cui 1999).||||||0.0305
73916155|NCT01191801|147361276|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Two sided P-Value|Chi-squared|||||||<0.0001
73916156|NCT01191801|147361279|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Two sided P-Value|Chi-squared|||||||<0.0001
73916157|NCT01191801|147361280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||<|0.0001|ONE_SIDED|95.0||||Unstratified one-sided P-Value|Log Rank|||||||<0.0001
73966294|NCT02349412|147468823|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.104|TWO_SIDED|95.0|-0.67|7.13|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score||||7.13|-0.67|0.104
74027396|NCT01157169|147607846|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||TWO_SIDED|90.0|87.44|101.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.46|87.44|
73916158|NCT01191801|147361281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3134|TWO_SIDED|95.0||||One sided P-Value|Log Rank|||||||0.3134
73916159|NCT02221947|147361330|OTHER||mean Tmax(h)|0.92|||||TWO_SIDED||||||||SD=0.206|Bryostatin plasma concentration: mean Tmax (h)||||
73916160|NCT02221947|147361330|OTHER||mean (h*ng/mL)|1.05|||||TWO_SIDED||||||||SD=0.330|Bryostatin plasma concentration AUC0-last (h\*ng/mL)||||
73966295|NCT02349412|147468824|SUPERIORITY||Mean Difference (Final Values)|3.12||||0.188|TWO_SIDED|95.0|-1.54|7.77|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score||||7.77|-1.54|0.188
73966296|NCT02349412|147468825|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.884|TWO_SIDED|95.0|-0.94|2.09|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Depression score||||2.09|-0.94|0.884
73966297|NCT02349412|147468826|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.033|TWO_SIDED|95.0|-1.54|-0.07|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Anxiety score||||-0.07|-1.54|0.033
73966298|NCT02349412|147468827|SUPERIORITY|||||||0.006|||||||Chi-squared|||||||0.006
73966299|NCT04337372|147468835|SUPERIORITY||||||=|0.002||||||F(2, 58) = 7.19|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The main effect of age is reported here.||||=.002
73966300|NCT04337372|147468835|SUPERIORITY||||||=|0.09||||||F(1.78, 103.37) = 2.48|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The main effect of condition is reported here.||||=.09
73966301|NCT04337372|147468835|SUPERIORITY||||||<|0.05||||||F(3.56, 103.37) = 2.55|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The interaction between age and condition is reported here.||||<.05
74027397|NCT01157169|147607847|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.06|||||TWO_SIDED|90.0|86.56|104.39|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.39|86.56|
74027398|NCT01330381|147607855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9002|||||||Cochran-Mantel-Haenszel|||||||0.9002
73916161|NCT00114101|147361331|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This study was designed to have 80% power, with the use of the log-rank test at a one-sided significance level of 0.05, to detect a hazard ratio of 1.4, assuming proportional hazards and an exponential time to event distribution. Under the assumed framework, 309 events were expected. The expected drop out rate before randomization was 15%.|Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.26|0.53||Participants were randomized with the use of a permuted-block design stratified by beta 2 microglobulin, prior use of thalidomide and prior use of lenalidomide. TTP was monitored with the use of a group sequential design for superiority and futility.|Log Rank|||||0.53|0.26|<0.001
73916162|NCT00114101|147361333|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52||||0.7|TWO_SIDED|95.0|0.26|1.02|||Log Rank|||||1.02|0.26|0.70
73916163|NCT00114101|147361334|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.41|0.69|||Fisher Exact|||||0.69|0.41|<0.001
73916164|NCT01539538|147361344|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of - 15% for lower boundary of 95% confidence interval|difference in proportion|12.9|||<|0.001|TWO_SIDED|95.0|3.69|22.11|||one-sided, z-test|||||22.11|3.69|<0.001
73916165|NCT01539538|147361344|SUPERIORITY_OR_OTHER||Difference in proportion|12.9||||0.007|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.007
73916166|NCT01774604|147361345|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||||||0.33
73916167|NCT01774604|147361346|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
74027399|NCT01330381|147607856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352|||||||Cochran-Mantel-Haenszel|||||||0.3520
74027400|NCT01330381|147607857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5228|||||||Cochran-Mantel-Haenszel|||||||0.5228
74027401|NCT01330381|147607866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.377|||||||Chi-squared|||||||0.377
74027402|NCT01330381|147607869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1599|||||||Van Elteren test|||||||0.1599
74027403|NCT01330381|147607870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Van Elteren test|||||||0.0003
74027404|NCT01330381|147607871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4647|||||||Van Elteren test|||||||0.4647
74027405|NCT01330381|147607872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren test|||||||<0.0001
74027406|NCT01330381|147607873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3044|||||||Van Elteren test|||||||0.3044
74027407|NCT00685178|147607879|SUPERIORITY||F-value for main effect of Condition|2.21||||0.531|TWO_SIDED|||||Using the proportion of negative urine samples obtained, the four groups were compared to determine whether there are any group differences in cocaine abstinence (as measured by negative urine samples).|Chi-squared||F-value for main effect of Drug Condition|||||0.531
74086001|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.288||0.7325||95.0|-0.667|0.469|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.469|-0.667|0.7325
74086002|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.278||0.8133||95.0|-0.614|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.482|-0.614|0.8133
74086003|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.285||0.9307||95.0|-0.588|0.538|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.538|-0.588|0.9307
74086004|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.439||0.2682||95.0|-1.364|0.385|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.385|-1.364|0.2682
74086005|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.294|STANDARD_ERROR_OF_MEAN|0.413||0.4784||95.0|-1.116|0.528|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.528|-1.116|0.4784
74086006|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.661|STANDARD_ERROR_OF_MEAN|0.298||0.0255||95.0|0.084|1.239|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.239|0.084|0.0255
74086007|NCT00442546|147725973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.448|STANDARD_ERROR_OF_MEAN|0.314||0.1591||95.0|-0.18|1.076|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.076|-0.180|0.1591
73916168|NCT01774604|147361347|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
73916169|NCT01774604|147361348|SUPERIORITY_OR_OTHER|||||||0.15|||||||Fisher Exact|||||||0.15
73916170|NCT01774604|147361349|SUPERIORITY_OR_OTHER|||||||0.75|||||||Fisher Exact|||||||0.75
74086008|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.372||0.0359||95.0|-1.52|-0.052|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.052|-1.520|0.0359
74086009|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.907|STANDARD_ERROR_OF_MEAN|0.374||0.0161||95.0|-1.644|-0.17|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.170|-1.644|0.0161
74086010|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.105|STANDARD_ERROR_OF_MEAN|0.319||0.7416||95.0|-0.733|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.523|-0.733|0.7416
74086011|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.324||0.3527||95.0|-0.939|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.336|-0.939|0.3527
73971319|NCT04117347|147483168|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.043|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.0676154|0.1545869|||||coefficient for an indicator for Light Therapy B (vs. Light Therapy A)|Analysis for right amygdala.||0.1545869|-0.0676154|
74086012|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.184|STANDARD_ERROR_OF_MEAN|0.3||0.5419||95.0|-0.776|0.409|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.409|-0.776|0.5419
74086013|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.305||0.9333||95.0|-0.628|0.577|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.577|-0.628|0.9333
74086014|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.354|STANDARD_ERROR_OF_MEAN|0.24||0.142||95.0|-0.827|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.120|-0.827|0.1420
74086015|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.245||0.829||95.0|-0.535|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.429|-0.535|0.8290
74086016|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.111|STANDARD_ERROR_OF_MEAN|0.441||0.0138||95.0|-1.989|-0.233|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||-0.233|-1.989|0.0138
74086017|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.416||0.23||95.0|-1.332|0.325|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.325|-1.332|0.2300
74086018|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.268||0.5151||95.0|-0.36|0.711|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||0.711|-0.360|0.5151
74086019|NCT00442546|147725974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.433|STANDARD_ERROR_OF_MEAN|0.295||0.146||95.0|-0.155|1.022|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.022|-0.155|0.1460
74086020|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.258|STANDARD_ERROR_OF_MEAN|0.463||0.5786||95.0|-1.17|0.655|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.655|-1.170|0.5786
73916171|NCT01774604|147361350|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||0.25
73916172|NCT01774604|147361351|SUPERIORITY_OR_OTHER|||||||0.1|||||||Fisher Exact|||||||0.10
73916173|NCT01192516|147361360|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age, gender, pain level, and body mass index at baseline.||||||.85
73916174|NCT01192516|147361363|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age, gender, and body mass index.||||||.06
73916175|NCT01192516|147361366|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Adjusted for age, gender, body mass index, and pain at baseline.|Mixed Models Analysis|||||||.36
73916176|NCT02321800|147361375|NON_INFERIORITY|The margin of noninferiority was 20%. Noninferiority was concluded if the lower bound of a 2-sided 95% CI for the difference in response rates between the 2 treatment groups was greater than -20%. If the noninferiority inference based on the 20% margin was concluded successfully, noninferiority inference based on the 15% margin was performed.|Treatment Difference|18.58|||||TWO_SIDED|95.0|8.23|28.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||28.92|8.23|
74086021|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.467||0.957||95.0|-0.895|0.946|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.946|-0.895|0.9570
74086022|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.434||0.986||95.0|-0.862|0.847|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.847|-0.862|0.9860
74086023|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.151|STANDARD_ERROR_OF_MEAN|0.442||0.7336||95.0|-1.021|0.72|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.720|-1.021|0.7336
74086024|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.384|STANDARD_ERROR_OF_MEAN|0.365||0.2939||95.0|-0.336|1.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.104|-0.336|0.2939
74086025|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.372||0.4615||95.0|-0.459|1.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.008|-0.459|0.4615
74086026|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.161|STANDARD_ERROR_OF_MEAN|0.347||0.6433||95.0|-0.845|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.523|-0.845|0.6433
74086027|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.356||0.9466||95.0|-0.678|0.726|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.726|-0.678|0.9466
74086028|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.424|STANDARD_ERROR_OF_MEAN|0.621||0.4967||95.0|-1.66|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.812|-1.660|0.4967
73916177|NCT02321800|147361376|OTHER||Treatment Difference|0.66|||||TWO_SIDED|95.0|-6.48|7.79||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||7.79|-6.48|
74086029|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.582||0.8659||95.0|-1.06|1.257|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.257|-1.060|0.8659
74086030|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.994|STANDARD_ERROR_OF_MEAN|0.451||0.0311||95.0|0.093|1.895|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.895|0.093|0.0311
74086031|NCT00442546|147725975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.995|STANDARD_ERROR_OF_MEAN|0.485||0.0441||95.0|0.027|1.962|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.962|0.027|0.0441
74086032|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.969|STANDARD_ERROR_OF_MEAN|0.439||0.0284||95.0|-1.835|-0.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.104|-1.835|0.0284
74086033|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.265|STANDARD_ERROR_OF_MEAN|0.444||0.5516||95.0|-1.141|0.611|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.611|-1.141|0.5516
74086034|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.38||0.479||95.0|-1.02|0.48|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.480|-1.020|0.4790
74086035|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.39||0.9947||95.0|-0.765|0.77|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.770|-0.765|0.9947
74086036|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.329||0.8943||95.0|-0.605|0.692|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.692|-0.605|0.8943
74086037|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.336||0.9767||95.0|-0.674|0.654|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.654|-0.674|0.9767
74086038|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.34||0.8117||95.0|-0.59|0.752|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.752|-0.590|0.8117
74086039|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.125|STANDARD_ERROR_OF_MEAN|0.351||0.7216||95.0|-0.818|0.567|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.567|-0.818|0.7216
74086040|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.592||0.8558||95.0|-1.286|1.07|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.070|-1.286|0.8558
74086041|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.422|STANDARD_ERROR_OF_MEAN|0.556||0.4501||95.0|-1.53|0.685|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.685|-1.530|0.4501
74086042|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.328|STANDARD_ERROR_OF_MEAN|0.45||0.4682||95.0|-0.57|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.227|-0.570|0.4682
74086043|NCT00442546|147725976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.492||0.5347||95.0|-0.675|1.289|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.289|-0.675|0.5347
73916178|NCT02321800|147361377|OTHER||Treatment Difference|0.72|||||TWO_SIDED|95.0|-3.48|4.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||4.92|-3.48|
73916179|NCT02321800|147361378|OTHER||Treatment Difference|15.31|||||TWO_SIDED|95.0|4.69|25.92||||||||25.92|4.69|
73916180|NCT02321800|147361379|OTHER||Treatment Difference|17.25|||||TWO_SIDED|95.0|6.92|27.58||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||27.58|6.92|
74086044|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.765|STANDARD_ERROR_OF_MEAN|0.407||0.0613||95.0|-1.568|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.037|-1.568|0.0613
74086045|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.936|STANDARD_ERROR_OF_MEAN|0.409||0.023||95.0|-1.741|-0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.130|-1.741|0.0230
73860099|NCT02214225|147266180|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) 18 through 64 years|1.67|||||TWO_SIDED|95.0|1.5|1.87|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.87|1.50|
73860100|NCT02214225|147266180|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) 18 through 64 years|1.76|||||TWO_SIDED|95.0|1.55|2.01|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||2.01|1.55|
73860101|NCT02214225|147266180|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) ≥ 65 years|1.3|||||TWO_SIDED|95.0|1.21|1.4|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.40|1.21|
73860102|NCT02214225|147266180|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) ≥ 65 years|1.38|||||TWO_SIDED|95.0|1.27|1.51|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.51|1.27|
73860103|NCT02214225|147266181|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) overall|15.3|||||TWO_SIDED|95.0|12.1|18.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||18.6|12.1|
73860104|NCT02214225|147266181|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) overall|20.1|||||TWO_SIDED|95.0|16.5|23.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||23.6|16.5|
73860105|NCT02214225|147266181|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) 18 through 64y|22.9|||||TWO_SIDED|95.0|17.7|28.2|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||28.2|17.7|
73916181|NCT02321800|147361380|OTHER||Treatment Difference|1.28|||||TWO_SIDED|95.0|-4.83|7.39||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||7.39|-4.83|
73916182|NCT02321800|147361381|OTHER||Treatment Difference|1.1|||||TWO_SIDED|95.0|-3.04|5.25||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||5.25|-3.04|
73916183|NCT02321800|147361382|OTHER||Treatment Difference|13.92|||||TWO_SIDED|95.0|3.21|24.63||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||24.63|3.21|
73916184|NCT02321800|147361387|OTHER||Treatment Difference|2.39|||||TWO_SIDED|95.0|-4.66|9.44||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||9.44|-4.66|
73916185|NCT02321800|147361388|OTHER||Treatment Difference|-0.26|||||TWO_SIDED|95.0|-6.57|6.05||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||6.05|-6.57|
73860106|NCT02214225|147266181|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) 18 through 64y|28.6|||||TWO_SIDED|95.0|23.1|34.1|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||34.1|23.1|
73860107|NCT02214225|147266181|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) ≥ 65 years|8.0|||||TWO_SIDED|95.0|4.3|11.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||11.6|4.3|
73860108|NCT02214225|147266181|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) ≥ 65 years|11.9|||||TWO_SIDED|95.0|7.7|16.0|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage.||16.0|7.7|
73860109|NCT02680574|147266198|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change of hemoglobin: Vadadustat minus Darbepoetin alfa|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.042|||TWO_SIDED|95.0|-0.09|0.07||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.07|-0.09|
73860110|NCT02680574|147266199|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.3 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|1.16|||=|0.2015|TWO_SIDED|95.0|0.93|1.446|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.446|0.930|=0.2015
73860111|NCT02680574|147266199|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.17|||=|0.0725|TWO_SIDED|95.0|1.012|1.355|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 382 and 344 respectively; median time to first event (Q1, Q3) = 50.07 (23.00, 82.86) weeks versus 51.93 (27.79, 91.00) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.355|1.012|=0.0725
73860112|NCT02680574|147266200|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.1|0.09||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.09|-0.10|
73860113|NCT02680574|147266201|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.777|TWO_SIDED|95.0|0.851|1.268|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.268|0.851|=0.7770
73860114|NCT02680574|147266201|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.2305|TWO_SIDED|95.0|0.972|1.267|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE plus hospitalization for heart failure or thromboembolic events excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 451 and 424 respectively; median time to first event (Q1, Q3) = 42.86 (19.71, 73.43) weeks versus 43.86 (21.36, 80.43) weeks, respectively.||1.267|0.972|=0.2305
73860115|NCT02680574|147266202|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.5509|TWO_SIDED|95.0|0.817|1.501|||Gray's Test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.501|0.817|=0.5509
73860116|NCT02680574|147266202|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.2531|TWO_SIDED|95.0|0.947|1.42|||Gray's Test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 198 and 178 respectively; median time to first event (Q1, Q3) = 45.57 (21.71, 73.29) weeks versus 47.36 (20.00, 88.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.420|0.947|=0.2531
73860117|NCT02680574|147266203|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|0.88|||=|0.4184|TWO_SIDED|95.0|0.61|1.258|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.258|0.610|=0.4184
73860118|NCT02680574|147266203|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.01|||=|0.8613|TWO_SIDED|95.0|0.792|1.293|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 127 and 131 respectively; median time to first event (Q1, Q3) = 48.29 (28.86, 76.14) weeks versus 48.43 (21.29, 92.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.293|0.792|=0.8613
73860119|NCT02680574|147266204|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.8041|TWO_SIDED|95.0|0.82|1.315|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.315|0.820|=0.8041
73860120|NCT02680574|147266204|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.09|||=|0.4577|TWO_SIDED|95.0|0.93|1.274|||Log Rank|||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 319 and 307 respectively; median time to first event (Q1, Q3) = 52.14 (28.71, 84.71) weeks versus 53.00 (30.71, 94.14) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.274|0.930|=0.4577
73916186|NCT02321800|147361389|OTHER||Treatment Difference|-1.07|||||TWO_SIDED|95.0|-3.42|1.29||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||1.29|-3.42|
73916187|NCT02321800|147361390|OTHER||Treatment Difference|9.02|||||TWO_SIDED|95.0|-0.37|18.41||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||18.41|-0.37|
73860121|NCT02847858|147266215|SUPERIORITY||Slope|1.16||||0.011|TWO_SIDED|95.0|0.26|2.07||Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) minus Arm2 (Control); Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to Post-visit Follow-up||2.07|0.26|0.011
73966302|NCT04337372|147468836|SUPERIORITY||||||=|0.557||||||F(2,47) = .592|MANOVA|||EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The main effect of age is reported here.||||=.557
73860122|NCT02847858|147266215|SUPERIORITY||Slope|1.64|||<|0.001|TWO_SIDED|95.0|1.01|2.07||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome||2.07|1.01|<0.001
73860123|NCT02847858|147266215|SUPERIORITY||Slope|0.48||||0.108|TWO_SIDED|95.0|-0.1|1.05||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome||1.05|-0.10|0.108
73860124|NCT02847858|147266216|SUPERIORITY||F statistic:Time X Arm Interaction|3.23||||0.04|TWO_SIDED|||||Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2,1611; Arm comparison is Intervention - Control; Time comparisons are 3 months - Baseline and 6 months - Baseline and 6 months - 3 months|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months or from Baseline to 6 months||||0.04
73860125|NCT02847858|147266216|SUPERIORITY||Slope|0.82||||0.218|TWO_SIDED|95.0|-0.48|2.11||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site||Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months|Arm comparison is Intervention - Control; Time comparison is 3 months - Baseline|2.11|-0.48|.218
73860126|NCT02847858|147266216|SUPERIORITY||Slope|1.58||||0.008|TWO_SIDED|95.0|0.38|2.77||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention - Control; Time comparison is 6 months - Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 6 months||2.77|0.38|0.008
73860127|NCT02847858|147266217|SUPERIORITY||F statistic:Time X Arm Interaction|3.72||||0.025|TWO_SIDED|||||Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2, 1007; Arm comparison is Intervention/Control; Time comparisons are 3 months/Baseline and 6 months/Baseline and 6 months/3 months|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months or to 6 months||||0.025
73860128|NCT02847858|147266217|SUPERIORITY||Odds Ratio (OR)|3.29||||0.042|TWO_SIDED|95.0|1.04|10.36||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 3 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months||10.36|1.04|0.042
73916188|NCT00730132|147361411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Pearson Chi-Square|||Significance of the differences in the number of patients per group who achieved goal TC levels on Visit 2.||||0.007
73916189|NCT00730132|147361412|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Chi square, continuity corrected. Asymptotic significance.|McNemar|||Significance of paired changes in the number of patients who achieved LDL-C target levels on Visit 2, for each treatment group comparison||||<0.001
73860129|NCT02847858|147266217|SUPERIORITY||Odds Ratio (OR)|5.54||||0.005|TWO_SIDED|95.0|1.7|18.06||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 6 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 6 months||18.06|1.7|0.005
73966303|NCT04337372|147468836|SUPERIORITY||||||=|0.47||||||F(2,47) = .767|MANOVA|||EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The main effect of condition is reported here.||||=.470
73966304|NCT04337372|147468836|SUPERIORITY||||||=|0.046||||||F(4,94) = 2.524|MANOVA|||EEG power, as measured by signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each condition. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The interaction of age and condition is reported here.||||=.046
73966305|NCT04337372|147468837|SUPERIORITY||||||=|0.664||||||F(2,45) = .413|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The main effect of age is reported here.||||=.664
73966306|NCT04337372|147468837|SUPERIORITY||||||=|0.768||||||F(2,45) = .266|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The main effect of condition is reported here.||||=.768
73971320|NCT04117347|147483168|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.018|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.0888691|0.1255146|||||coefficient for an indicator for Light Therapy C (vs. Light Therapy A)|Analysis for right amygdala.||0.1255146|-0.0888691|
73971321|NCT02505984|147483169|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
74086046|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.4||0.8306||95.0|-0.703|0.875|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.875|-0.703|0.8306
74086047|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.439|STANDARD_ERROR_OF_MEAN|0.407||0.2814||95.0|-1.242|0.363|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.363|-1.242|0.2814
73860130|NCT02847858|147266218|SUPERIORITY||Slope|1.62|||<|0.001|TWO_SIDED|95.0|1.43|1.82||Time main effect; a priori threshold for statistical significance p \<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is post-app minus pre-app|Null hypothesis: No change in contraception knowledge from immediate pre-app to immediate post-app among Intervention group participants||1.82|1.43|<0.001
73860131|NCT02847858|147266219|SUPERIORITY||Odds Ratio (OR)|2.22||||0.055|TWO_SIDED|95.0|0.98|5.01||Arm main effect; a priori threshold for statistical significance p\<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who discussed birth control with health care provider at visit||5.01|0.98|0.055
73860132|NCT02847858|147266220|SUPERIORITY||Odds Ratio (OR)|1.66||||0.227|TWO_SIDED|95.0|0.73|3.78||Arm main effect; a priori threshold for statistical significance p\<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who receive/make appointment/get prescription for a non-barrier method||3.78|0.73|0.227
73860133|NCT00681564|147266229|SUPERIORITY_OR_OTHER|||||||0.98||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (baseline). Note: data analysis of patients who completed the study protocol (n=86). Intention-to-treat analysis analysis was not used because its application for the evaluation of continuous data would imply imputing missing data for patients lost to follow-up. Mean and standard deviation of flow-mediated dilatation, including data from all patients randomized in this study, is reported in the field of baseline characteristics.||||0.98
73860134|NCT00681564|147266229|SUPERIORITY_OR_OTHER|||||||0.005||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (24 hours).||||0.005
73860135|NCT00681564|147266229|SUPERIORITY_OR_OTHER|||||||0.43||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||"Statistical analysis: Brachial Artery Flow-mediated Dilation (12 weeks). Intention-to-treat analysis was not used because input of values for patients lost at follow-up will artificially amplify the precision of outcome measures.~Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.0.1. The Cochrane Collaboration, 2008. www.cochrane-handbook.org."||||0.43
73860136|NCT02818036|147266399|OTHER|difference in neural activity to social task when taking naltrexone as compared to placebo|||||<|0.01||||||a priori threshold for significance was p\<.05|t-test, 1 sided|degrees of freedom = 75||||||<.01
74086048|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.353||0.8637||95.0|-0.636|0.757|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.757|-0.636|0.8637
74086049|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.359||0.9585||95.0|-0.727|0.689|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.689|-0.727|0.9585
74086050|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.272|STANDARD_ERROR_OF_MEAN|0.321||0.3975||95.0|-0.906|0.361|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.361|-0.906|0.3975
73860137|NCT02818036|147266400|OTHER|differences in feelings of social connection between those who took naltrexone and those who took placebo||||||0.338||||||a priori threshold for statistical significance was p\<.05|t-test, 2 sided|||||||.338
73860138|NCT01038713|147266401|SUPERIORITY_OR_OTHER|||||||0.22||||||Analysis comparing the number of patients who had stent occlusion|Chi-squared|3 x 2 contingency table comparing all three groups||||||0.22
73860139|NCT01038713|147266401|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of attempted surgical resection||||0.14
73916190|NCT00730132|147361413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.757|STANDARD_DEVIATION|12.30606||||95.0||||||||Descriptive statistics of relative (%) change in TC levels from Baseline at Visit 2||||
73916191|NCT00730132|147361413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.0|STANDARD_DEVIATION|15.662||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2||||
73916192|NCT00730132|147361413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.8181|STANDARD_DEVIATION|14.03545||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2||||
73916193|NCT00730132|147361413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.80928|STANDARD_ERROR_OF_MEAN|1.48621||0.143|TWO_SIDED|95.0|-6.307|0.6884|||Games-Howell|||Statin Dose Titration compared to New Statin||.6884|-6.3070|.143
73916194|NCT00730132|147361413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.74811|STANDARD_ERROR_OF_MEAN|1.56351||0.001|TWO_SIDED|95.0|-9.4298|-2.0664|||Games-Howell|||Statin Dose Titration compared to Ezetimbe||-2.0664|-9.4298|.001
73916195|NCT00730132|147361413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.93883|STANDARD_ERROR_OF_MEAN|1.38286||0.086|TWO_SIDED|95.0|-6.1948|0.3171|||Games-Howell|||New Statin compared to Ezetimibe||.3171|-6.1948|.086
73966307|NCT04337372|147468837|SUPERIORITY||||||=|0.2||||||F(4,90) = 1.531|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The interaction of age and condition is reported.||||=.200
73966308|NCT04337372|147468838|SUPERIORITY||||||=|0.022||||||F(2, 57) = 4.11|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The main effect of age is reported here.||||=.022
73966309|NCT04337372|147468838|SUPERIORITY||||||=|0.004||||||F(2, 114) = 5.69|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The main effect of condition is reported here.||||=.004
73971322|NCT02505984|147483169|SUPERIORITY|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
73860140|NCT01038713|147266401|SUPERIORITY_OR_OTHER|||||||0.96|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of death between groups||||0.96
73860141|NCT01038713|147266402|SUPERIORITY_OR_OTHER|||||||1|||||||ANOVA|||||||1.00
73916196|NCT00730132|147361414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.8174|STANDARD_DEVIATION|19.85205||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
73916197|NCT00730132|147361414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.2488|STANDARD_DEVIATION|20.78727||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
73916198|NCT00730132|147361414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.0665|STANDARD_DEVIATION|15.5901||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
73916199|NCT00730132|147361414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.43138|STANDARD_ERROR_OF_MEAN|2.01009||0.756|TWO_SIDED|95.0|-6.1604|3.2977|||Games-Howell|||Statin Dose Titration compared to New Statin||3.2977|-6.1604|.756
73916200|NCT00730132|147361414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.24911|STANDARD_ERROR_OF_MEAN|1.97821||0.023|TWO_SIDED|95.0|-9.9072|-0.591|||Games-Howell|||Statin Dose Titration compared to Ezetimibe||-.5910|-9.9072|.023
73916201|NCT00730132|147361414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.81773|STANDARD_ERROR_OF_MEAN|1.88425||0.107|TWO_SIDED|95.0|-8.2523|0.6169|||Games-Howell|||New Statin compared to Ezetimibe||.6169|-8.2523|.107
73916202|NCT00420927|147361416|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Chi-squared|P value is from Pearson's chi-square test.||||||0.023
73916203|NCT00420927|147361417|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||Regression, Logistic|||||||0.082
73916204|NCT00420927|147361418|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Logistic|||||||0.280
73916205|NCT00420927|147361418|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Regression, Logistic|||||||0.287
73916206|NCT00420927|147361419|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Regression, Logistic|||||||0.026
73916207|NCT00420927|147361419|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Regression, Logistic|||||||0.009
73916208|NCT00420927|147361420|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Regression, Logistic|||||||0.060
73916209|NCT00420927|147361420|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||Regression, Logistic|||||||0.063
73971323|NCT02505984|147483169|SUPERIORITY|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
73971324|NCT02505984|147483169|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
73966310|NCT04337372|147468838|SUPERIORITY||||||=|0.168||||||F(4, 114) = 1.64|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The interaction of age and condition is reported here.||||=.168
73966311|NCT03611153|147468847|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.040
73966312|NCT03611153|147468849|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
73966313|NCT03611153|147468850|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|||Right atrial pressure||||0.805
73966314|NCT03611153|147468850|SUPERIORITY|||||||0.148|||||||t-test, 2 sided|||pulmonary artery systolic pressure||||0.148
73860142|NCT03777917|147266409|SUPERIORITY||Difference in Response Rates|72.1|||<|0.0001|TWO_SIDED|95.0|47.5|83.5|||Fisher Exact|The Fisher's exact test was used to test for the superiority of treatment (Belotero Balance®) over control.|Two-sided Newcombe confidence interval (CI) for the difference in response rates.|||83.5|47.5|< 0.0001
73860143|NCT00042432|147266419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.67||||0.006||95.0|1.6|20.06|||Cochran-Mantel-Haenszel|Adjusted for baseline glomenular filtration rate (GFR) strata|Logit estimates|||20.06|1.60|0.006
73860144|NCT00042432|147266420|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|Adusted for baseline glomerular filtration rate (GFR) strata||||||<0.001
73860145|NCT00657150|147266421|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%|Risk Difference (Percentage)|-1.08|||<|0.0001||95.0|-3.79|1.64||Superiority p-value = 0.4367|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.64|-3.79|< 0.0001
73860146|NCT00657150|147266422|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.91||||0.029||95.0|-3.64|-0.19|||Normal approximation|Normal approximation of independent binomial distribution without stratification||||-0.19|-3.64|0.029
73860147|NCT00657150|147266423|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.79||||0.0358||95.0|-3.47|-0.12|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||-0.12|-3.47|0.0358
73860148|NCT00657150|147266424|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.96||||0.4839|TWO_SIDED|95.0|-3.65|1.73|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.73|-3.65|0.4839
73860149|NCT00657150|147266425|SUPERIORITY_OR_OTHER|||||||0.0612||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0612
73966315|NCT03611153|147468850|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Mean pulmonary artery pressure||||0.090
73966316|NCT03611153|147468851|SUPERIORITY|||||||0.786|||||||t-test, 2 sided|||Right atrial pressure||||0.786
73860150|NCT00657150|147266426|SUPERIORITY_OR_OTHER|||||||0.6231||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6231
73860151|NCT00657150|147266427|SUPERIORITY_OR_OTHER|||||||0.4977||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4977
73966317|NCT03611153|147468851|SUPERIORITY|||||||0.796|||||||t-test, 2 sided|||Pulmonary artery systolic pressure||||0.796
73966318|NCT03611153|147468851|SUPERIORITY|||||||0.703|||||||t-test, 2 sided|||Mean pulmonary artery pressure||||0.703
73966319|NCT03611153|147468852|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||||||0.418
73860152|NCT00657150|147266428|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6870
73860153|NCT00657150|147266429|SUPERIORITY_OR_OTHER|||||||0.4022||95.0|||||Fisher Exact|||Comparison versus Enoxaparin for the category major bleeding events||||0.4022
73860154|NCT00657150|147266429|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|0.8||||0.3305|TWO_SIDED|95.0|-0.8|2.3|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category major and clinically relevant bleeding events||2.3|-0.8|0.3305
73860155|NCT00657150|147266429|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|1.4||||0.2626|TWO_SIDED|95.0|-1.1|3.9|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category any bleeding events||3.9|-1.1|0.2626
73860156|NCT02649192|147266437|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2015-16 season||||0.90
73966320|NCT03611153|147468853|SUPERIORITY|||||||0.669|||||||t-test, 2 sided|||||||0.669
73966321|NCT04840199|147468864|SUPERIORITY||Mean Difference (Net)|-0.031||||0.2|TWO_SIDED|95.0|-0.08|0.018||No adjustment for multiple comparisons|Regression, Linear||Treatment effect was estimated as the difference in mean change in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a linear regression model (0 reflects no difference between arms).|||0.018|-0.080|0.20
73966322|NCT04840199|147468865|SUPERIORITY||Risk Difference (RD)|0.172||||0.19|TWO_SIDED|95.0|-0.073|0.438||No adjustment for multiple comparisons|Chan/Zhang exact test diff. proportions||An exact 95% confidence interval around the observed difference in proportions (and the associated p-value) was constructed based on the standardized statistic and inverting two 1-sided tests (Chan-Zhang method).|||0.438|-0.073|0.19
73966323|NCT04840199|147468867|SUPERIORITY||Odds Ratio (OR)|0.91||||0.12|TWO_SIDED|95.0|0.8|1.03||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Early treatment phase comparison||1.03|0.80|0.12
73966324|NCT04840199|147468867|SUPERIORITY||Odds Ratio (OR)|0.92||||0.009|TWO_SIDED|95.0|0.87|0.98||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Late treatment phase comparison||0.98|0.87|0.009
73971325|NCT02505984|147483170|SUPERIORITY||||||>|0.9|||||||Wilcoxon (Mann-Whitney)|||||||>0.9
73971326|NCT02505984|147483170|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
73971327|NCT02505984|147483171|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
73971328|NCT02505984|147483171|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
73916210|NCT00420927|147361421|SUPERIORITY_OR_OTHER|||||||0.395||95.0|||||Regression, Logistic|||||||0.395
73916211|NCT00420927|147361421|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||Regression, Logistic|||||||0.640
73916212|NCT00420927|147361422|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Regression, Logistic|||||||0.159
73916213|NCT00420927|147361422|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||Regression, Logistic|||||||0.217
73916214|NCT00420927|147361423|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Regression, Logistic|||||||0.060
73916215|NCT00420927|147361423|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||Regression, Logistic|||||||0.043
73916216|NCT00420927|147361424|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.004
73916217|NCT00420927|147361424|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.049
73916218|NCT00420927|147361425|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Regression, Logistic|||||||0.240
73860157|NCT02649192|147266437|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2016-17 season||||0.49
73860158|NCT02649192|147266437|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2017-18 season||||0.50
73860159|NCT02649192|147266437|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2015-16 season||||0.90
73916219|NCT00420927|147361425|SUPERIORITY_OR_OTHER|||||||0.271||95.0|||||Regression, Logistic|||||||0.271
73971329|NCT02505984|147483172|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.7
73860160|NCT02649192|147266437|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2016-17 season||||0.76
73860161|NCT02649192|147266437|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2017-18 season||||0.65
73916220|NCT00420927|147361426|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Regression, Logistic|||||||0.230
73916221|NCT00420927|147361426|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Regression, Logistic|||||||0.550
73916222|NCT00420927|147361427|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||Regression, Logistic|||||||0.301
73916223|NCT00420927|147361427|SUPERIORITY_OR_OTHER|||||||0.188||95.0|||||Regression, Logistic|||||||0.188
73916224|NCT00420927|147361428|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||Regression, Logistic|||||||0.314
73916225|NCT00420927|147361428|SUPERIORITY_OR_OTHER|||||||0.235||95.0|||||Regression, Logistic|||||||0.235
73916226|NCT00420927|147361429|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.030
73916227|NCT00420927|147361429|SUPERIORITY_OR_OTHER|||||||0.403||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.403
73916228|NCT00420927|147361430|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.036
73916229|NCT00420927|147361430|SUPERIORITY_OR_OTHER|||||||0.349||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.349
73916230|NCT00420927|147361431|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.037
73916231|NCT00420927|147361431|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||<0.001
73916232|NCT00420927|147361432|SUPERIORITY_OR_OTHER|||||||0.192||95.0|||||Regression, Logistic|||||||0.192
73916233|NCT00420927|147361432|SUPERIORITY_OR_OTHER|||||||0.241||95.0|||||Regression, Logistic|||||||0.241
73916234|NCT00420927|147361433|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Regression, Logistic|||||||0.028
73916235|NCT00420927|147361433|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Regression, Logistic|||||||0.014
73916236|NCT00420927|147361434|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Regression, Logistic|||||||0.074
73916237|NCT00420927|147361434|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||Regression, Logistic|||||||0.077
73916238|NCT00320411|147361438|SUPERIORITY_OR_OTHER||percentage of participants|17.2||||||95.0|8.6|29.4||||||||29.4|8.6|
73916239|NCT00320411|147361440|SUPERIORITY_OR_OTHER||percentage of participants|32.3||||||95.0|20.0|44.7||||||||44.7|20.0|
73916240|NCT00320411|147361441|SUPERIORITY_OR_OTHER||percentage of participants|22.8||||||95.0|11.6|34.0||||||||34.0|11.6|
73916241|NCT00843024|147361475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.003|TWO_SIDED|95.0|0.09|0.3||Adjusted for multiplicity according to the fixed sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 10 mg/Naproxen 60 mg minus placebo|||0.30|0.09|0.003
73916242|NCT00843024|147361475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.003|TWO_SIDED|95.0|0.07|0.26||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 30 mg/Naproxen180 mg minus placebo|||0.26|0.07|0.003
73916243|NCT00843024|147361475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.003|TWO_SIDED|95.0|0.05|0.22||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 85 mg/Naproxen 500 mg minus placebo|||0.22|0.05|0.003
73916244|NCT02615145|147361500|SUPERIORITY|||||||0.111||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||||0.1110
73916245|NCT02615145|147361500|SUPERIORITY||difference in LS means|1.64||||0.2704|TWO_SIDED|95.0|-1.28|4.56||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||4.56|-1.28|0.2704
73916246|NCT02615145|147361500|SUPERIORITY||difference in LS means|-0.09||||0.9516|TWO_SIDED|95.0|-3.17|2.98||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||2.98|-3.17|0.9516
73916247|NCT02615145|147361500|SUPERIORITY||difference in LS means|-1.73||||0.0489|TWO_SIDED|95.0|-3.46|-0.01||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||-0.01|-3.46|0.0489
73916248|NCT02615145|147361500|SUPERIORITY|||||||0.9785||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||||0.9785
73971330|NCT02505984|147483172|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
74086051|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.154|STANDARD_ERROR_OF_MEAN|0.327||0.6386||95.0|-0.799|0.491|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.491|-0.799|0.6386
73860162|NCT02649192|147266437|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2015-16 season||||0.90
73860163|NCT02649192|147266437|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2016-17 season||||0.76
73860164|NCT02649192|147266437|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2017-18 season||||0.54
73860165|NCT02649192|147266437|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2015-16 season||||0.90
73860166|NCT02649192|147266437|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2016-17 season||||0.95
73860167|NCT02649192|147266437|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2017-18 season||||0.34
73860168|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|H1N1||0|0|
73860169|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|-23.6|||||TWO_SIDED|95.0|-51.7|6.2|||||Treatment group minus placebo|H1N1||6.2|-51.7|
73860170|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|-13.0|||||TWO_SIDED|95.0|-49.4|26.5|||||Treatment group minus placebo|H1N1||26.5|-49.4|
73860171|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|-10.0|||||TWO_SIDED|95.0|-70.1|56.1|||||Treatment group minus placebo|H3N2||56.1|-70.1|
73860172|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|-8.6|||||TWO_SIDED|95.0|-38.8|20.6|||||Treatment group minus placebo|H3N2||20.6|-38.8|
73860173|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|22.7|||||TWO_SIDED|95.0|-17.5|57.9|||||Treatment group minus placebo|H3N2||57.9|-17.5|
73860174|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|B/Phuket||0|0|
73860175|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|-26.4|||||TWO_SIDED|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Phuket||5.8|-54.1|
73860176|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|16.9|||||TWO_SIDED|95.0|-23.1|53.3|||||Treatment group minus placebo|B/Phuket||53.3|-23.1|
73860177|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|B/Brisbane||0|0|
73860178|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|-26.4|||||TWO_SIDED|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Brisbane||5.8|-54.1|
73860179|NCT02649192|147266438|SUPERIORITY||Treatment Difference in Seroconversion R|-8.4|||||TWO_SIDED|95.0|-45.4|30.5|||||Treatment group minus placebo|B/Brisbane||30.5|-45.4|
73860180|NCT03849690|147266442|OTHER|Analysis of variance (ANOVA) performed on natural log(ln)-transformed TAK-906 Cmax which exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as random effect. Each ANOVA included calculation of least-squares means(LSM) and difference between treatment LSM. Geometric mean ratios and 90% confidence interval (CI) were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.87||||0.3011|TWO_SIDED|90.0|0.7|1.09|||ANOVA|||||1.09|0.70|0.3011
73860181|NCT03849690|147266443|OTHER|ANOVA was performed on ln-transformed TAK-906 AUClast which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90 percent (%) CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.0865|TWO_SIDED|90.0|0.77|0.99|||ANOVA|||||0.99|0.77|0.0865
73860182|NCT03849690|147266444|OTHER|ANOVA was performed on ln-transformed TAK-906 AUC∞ which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90% CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.3011|TWO_SIDED|90.0|0.78|1.0|||ANOVA|||||1.00|0.78|0.3011
73860183|NCT00468845|147266455|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1378||95.0||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA|||||||0.1378
73971331|NCT02505984|147483172|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
73860184|NCT00468845|147266455|SUPERIORITY_OR_OTHER_LEGACY|||||||0.471||95.0||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA|||||||0.4710
73860185|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.7752
73860186|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3375||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.3375
73860187|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7029||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.7029
73971332|NCT03687086|147483173|SUPERIORITY||Odds Ratio (OR)|1.95|STANDARD_ERROR_OF_MEAN|0.63||0.039|TWO_SIDED|95.0|1.03|3.7|||Regression, Logistic|||||3.70|1.03|.039
74086052|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.702|STANDARD_ERROR_OF_MEAN|0.397||0.0813||95.0|-1.493|0.089|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.089|-1.493|0.0813
73916249|NCT02615145|147361500|SUPERIORITY||difference in LS means|-0.13||||0.9379|TWO_SIDED|95.0|-3.37|3.11||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||3.11|-3.37|0.9379
73916250|NCT02615145|147361500|SUPERIORITY||difference in LS means|0.07||||0.9678|TWO_SIDED|95.0|-3.33|3.47||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||3.47|-3.33|0.9678
73916251|NCT02615145|147361500|SUPERIORITY||difference in LS means|0.2||||0.8373|TWO_SIDED|95.0|-1.7|2.1||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||2.10|-1.70|0.8373
73966325|NCT04840199|147468867|SUPERIORITY||Odds Ratio (OR)|1.17||||0.24|TWO_SIDED|95.0|0.9|1.53||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Post treatment phase comparison||1.53|0.90|0.24
73860188|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8618||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.8618
73860189|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2117||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2117
73860190|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6255||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.6255
73860191|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0942||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.0942
73860192|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9907||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.9907
73860193|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4678||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.4678
73860194|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.5500
73860195|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9333||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.9333
73860196|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7396||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.7396
73860197|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2932||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.2932
73860198|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0164||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0164
73860199|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2468||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.2468
73860200|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.7022
73860201|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7257||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.7257
73860202|NCT00468845|147266456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3854||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.3854
73860203|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5997||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5997
73860204|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8582||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8582
73860205|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3704||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.3704
73860206|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9747||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.9747
73860207|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2033||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2033
73860208|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2752
73860209|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0183||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.0183
73860210|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6906||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.6906
73860211|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5446||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.5446
73916252|NCT02615145|147361500|SUPERIORITY||Mean Difference (Final Values)|6.37|||<|0.0001|TWO_SIDED|95.0|5.417|7.32|||paired t-test|paired t-test of whether difference in means is 0||Week 12 vs Baseline across all participants||7.320|5.417|< 0.0001
73916253|NCT02615145|147361500|SUPERIORITY||Mean Difference (Final Values)|10.15|||<|0.0001|TWO_SIDED|95.0|8.936|11.362|||paired t-test|paired t-test of whether difference in means is 0||Week 48 vs Baseline across all participants||11.362|8.936|< 0.0001
73916254|NCT02615145|147361505|SUPERIORITY|||||||0.5751||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EOT||||0.5751
73916255|NCT02615145|147361505|SUPERIORITY||difference in LS means|2.29||||0.5176|TWO_SIDED|95.0|-4.66|9.23||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||9.23|-4.66|0.5176
73916256|NCT02615145|147361505|SUPERIORITY||difference in LS means|0.324||||0.9308|TWO_SIDED|95.0|-7.0|7.64||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||7.64|-7.00|0.9308
73916257|NCT02615145|147361505|SUPERIORITY||difference in LS means|-1.96||||0.3462|TWO_SIDED|95.0|-6.06|2.13||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||2.13|-6.06|0.3462
73916258|NCT02615145|147361505|SUPERIORITY|||||||0.7016||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 Weeks after EoT||||0.7016
73916259|NCT02615145|147361505|SUPERIORITY||difference in LS means|-2.61||||0.4002|TWO_SIDED|95.0|-8.71|3.49||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||3.49|-8.71|0.4002
73916260|NCT02615145|147361505|SUPERIORITY||difference in LS means|-2.33||||0.475|TWO_SIDED|95.0|-8.74|4.08||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||4.08|-8.74|0.4750
73916261|NCT02615145|147361505|SUPERIORITY||difference in LS means|0.282||||0.874|TWO_SIDED|95.0|-3.21|3.77||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||3.77|-3.21|0.8740
73916262|NCT02615145|147361505|SUPERIORITY|||||||0.7211||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||||0.7211
73916263|NCT02615145|147361505|SUPERIORITY||difference in LS means|-3.67||||0.4256|TWO_SIDED|95.0|-12.7|5.39||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||5.39|-12.7|0.4256
73916264|NCT02615145|147361505|SUPERIORITY||difference in LS means|-3.01||||0.5347|TWO_SIDED|95.0|-12.6|6.54||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||6.54|-12.6|0.5347
73916265|NCT02615145|147361505|SUPERIORITY||difference in LS means|0.654||||0.792|TWO_SIDED|95.0|-4.23|5.54||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||5.54|-4.23|0.7920
74086053|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.37||0.31||95.0|-1.114|0.358|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.358|-1.114|0.3100
73916266|NCT02615145|147361505|SUPERIORITY||Mean Difference (Final Values)|5.64|||<|0.0001|TWO_SIDED|95.0|3.355|7.935|||paired t-test|paired t-test of mean difference from 0||Baseline to EOT across all participants||7.935|3.355|< 0.0001
73916267|NCT02615145|147361505|SUPERIORITY||Mean Difference (Final Values)|10.21|||<|0.0001|TWO_SIDED|95.0|8.113|12.299|||paired t-test|paired t-test of mean difference versus 0||Baseline vs 12 weeks after EOT across all participants||12.299|8.113|< 0.0001
73916268|NCT02615145|147361505|SUPERIORITY||Mean Difference (Final Values)|10.13|||<|0.0001|TWO_SIDED|95.0|7.259|12.992|||paired t-test|paired t-test of mean difference versus 0||baseline vs 48 weeks after EOT across all participants||12.992|7.259|< 0.0001
73916269|NCT02615145|147361506|SUPERIORITY|||||||0.3869||||||Between group change comparison: overall. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||||0.3869
73916270|NCT02615145|147361506|SUPERIORITY||difference in LS means|-1.89||||0.3125|TWO_SIDED|95.0|-5.57|1.79||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.79|-5.57|0.3125
73916271|NCT02615145|147361506|SUPERIORITY||difference in LS means|-2.65||||0.1741|TWO_SIDED|95.0|-6.48|1.18||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.18|-6.48|0.1741
73916272|NCT02615145|147361506|SUPERIORITY||difference in LS means|-0.76||||0.4941|TWO_SIDED|95.0|-2.94|1.42||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.42|-2.94|0.4941
73916273|NCT02615145|147361506|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8842|TWO_SIDED|95.0|-1.271|1.096|||paired t-test|paired t-test of mean difference vs 0||Change from Baseline to Final visit across all participants||1.096|-1.271|0.8842
73916274|NCT03727347|147361510|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Hypothesis was that the improvement (decrease) in rTNSS mean score, from baseline to 12 weeks, would exceed 1 point||||||<0.0001
73916275|NCT02837783|147361517|SUPERIORITY|||||||0.283|||||||Wilcoxon rank sum test|||||||0.283
73916276|NCT02216591|147361532|SUPERIORITY|||||||0.013|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was significant, F(1,16) = 7.76, p = 0.013.||||||.013
73916277|NCT02216591|147361533|SUPERIORITY|||||||0.274|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = 1.29, p = 0.274||||||.274
73916278|NCT02216591|147361534|SUPERIORITY|||||||0.41|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = .72, p = 0.410||||||.410
74086054|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.831|STANDARD_ERROR_OF_MEAN|0.357||0.0231||95.0|0.118|1.545|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.545|0.118|0.0231
73916279|NCT00279305|147361552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.104||0.05|TWO_SIDED|95.0|-0.0699|0.348|||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||0.348|-0.0699|0.05
73916280|NCT00056316|147361623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control|||||.05
73916281|NCT00056316|147361624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.07||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control|||||.05
73916282|NCT01246401|147361669|SUPERIORITY|||||||0.431|||||||Welch's T Test|||||||0.431
73916283|NCT01246401|147361670|SUPERIORITY|||||||0.087|||||||Welch's T Test|||||||0.087
73916284|NCT01246401|147361672|SUPERIORITY|||||||0.03||||||Wilcoxon one sided|Wilcoxon (Mann-Whitney)|||||||0.03
73916285|NCT01246401|147361677|SUPERIORITY|||||||0.03962|||||||Chi-squared|||||||0.03962
73916286|NCT00166114|147361679|SUPERIORITY_OR_OTHER|||||||0.918|||||||Chi-squared|||Chi Square test was performed comparing actual vs. expected non- and partial response or response to either escitalopram or desipramine treatment.||||.918
73916287|NCT02397785|147361695|SUPERIORITY|||||||0.8979|||||||t-test, 2 sided|||It was calculated that 52 participants (26 in each arm) was sufficient to detect a 30% reduction in the VAS score (⍺ = 0.05, β = 0.80) from baseline to 12 weeks using paired t-tests, assuming average pain of 80-90 on the VAS and 10% drop-out. Because stratified randomization was performed on the basis of levator ani muscle spasm, there was an imbalance between the size of the sham and active groups, and 58 subjects were ultimately recruited with approval from the Institutional Review Board.||||0.8979
73966326|NCT04840199|147468870|SUPERIORITY||Mean Difference (Net)|0.0002||||0.95|TWO_SIDED|95.0|-0.0062|0.0066||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Early treatment phase comparison||0.0066|-0.0062|0.95
73966327|NCT04840199|147468870|SUPERIORITY||Mean Difference (Net)|-0.0007||||0.28|TWO_SIDED|95.0|-0.0019|0.0005||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Late treatment phase comparison||0.0005|-0.0019|0.28
73966328|NCT04840199|147468870|SUPERIORITY||Mean Difference (Net)|0.0056||||0.077|TWO_SIDED|95.0|-0.0006|0.0118||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Post treatment phase comparison||0.0118|-0.0006|0.077
74027408|NCT00685178|147607880|SUPERIORITY||Spearmann's rank correlation|0.969|||<|0.001|TWO_SIDED||||||ANOVA||CR subjects only|Analyses were performed to measure the correlation between CR groups (topiramate + CR and Placebo + CR) and abstinence.||||<0.001
73916288|NCT02397785|147361696|SUPERIORITY|||||||0.9338|||||||Sign test|||||||0.9338
73916289|NCT02397785|147361697|SUPERIORITY|||||||0.1568|||||||Sign test|||||||0.1568
73916290|NCT02397785|147361698|SUPERIORITY|||||||0.3817|||||||Sign test|||||||0.3817
73916291|NCT02397785|147361699|SUPERIORITY|||||||0.286|||||||Sign test|||||||0.2860
73916292|NCT02397785|147361700|SUPERIORITY|||||||0.2884|||||||Sign test|||||||0.2884
73916293|NCT02397785|147361701|SUPERIORITY|||||||0.0855|||||||Sign test|||||||0.0855
73916294|NCT02397785|147361702|SUPERIORITY|||||||0.0287|||||||Sign test|||||||0.0287
73916295|NCT02397785|147361703|SUPERIORITY|||||||0.2887|||||||Sign test|||||||0.2887
73916296|NCT02397785|147361704|SUPERIORITY|||||||0.9954|||||||Sign test|||||||0.9954
73916297|NCT02397785|147361705|SUPERIORITY|||||||0.0574|||||||Sign test|||||||0.0574
73916298|NCT02397785|147361706|SUPERIORITY|||||||0.7827|||||||Sign test|||||||0.7827
73916299|NCT02397785|147361707|SUPERIORITY|||||||0.2114|||||||Sign test|||||||0.2114
73916300|NCT02397785|147361708|SUPERIORITY|||||||0.4986|||||||Sign test|||||||0.4986
73916301|NCT02397785|147361709|SUPERIORITY|||||||0.461|||||||Sign test|||||||0.4610
73916302|NCT02397785|147361710|SUPERIORITY|||||||0.2556|||||||Sign test|||||||0.2556
73916303|NCT02397785|147361711|SUPERIORITY|||||||0.0723|||||||t-test, 2 sided|||||||0.0723
73916304|NCT02397785|147361712|SUPERIORITY|||||||0.7456|||||||t-test, 2 sided|||||||0.7456
73916305|NCT02397785|147361713|SUPERIORITY|||||||0.138|||||||t-test, 2 sided|||||||0.1380
73916306|NCT02397785|147361714|SUPERIORITY|||||||0.3155|||||||t-test, 2 sided|||||||0.3155
73916307|NCT02557646|147361753|SUPERIORITY_OR_OTHER|||||||0.0437|TWO_SIDED||||||Chi-squared|||Cumulative dose of ribavirin \>90%: the relationship between cumulative dose and SVR response in participants in whom the cumulative dose of ribavirin exceeded 90% was analyzed using Chi-square test.||||0.0437
73916308|NCT02557646|147361755|SUPERIORITY_OR_OTHER|||||||0.6859|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose ribavirin and virological response was analyzed using Chi-square test.||||0.6859
73916309|NCT02557646|147361756|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose ribavirin and sustained virological response (SVR) was analyzed using Chi-square test.||||0.3740
73916310|NCT02557646|147361757|SUPERIORITY_OR_OTHER|||||||0.0263|TWO_SIDED||||||Chi-squared, Corrected|||The relationship between the body weight-normalized dose of ribavirin and virological response was analyzed using Chi-square test.||||0.0263
73916311|NCT02557646|147361758|SUPERIORITY_OR_OTHER|||||||0.0475|TWO_SIDED||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and sustained virological (SVR) response was analyzed using Chi-square test.||||0.0475
73916312|NCT02557646|147361764|SUPERIORITY_OR_OTHER|||||||0.1499|TWO_SIDED||||||Chi-squared|||The relationship between the cumulative dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.1499
73916313|NCT02557646|147361765|SUPERIORITY_OR_OTHER|||||||0.5885|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.5885
73916314|NCT02557646|147361766|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.0062
73916315|NCT01115101|147361770|NON_INFERIORITY_OR_EQUIVALENCE|VAS score at 24h were defined as primary endpoint because of the expectation of the maximal effect at this time. Testing for differences of continuous variables between the study groups at baseline was accomplished by the 2-sample t test for independent samples or the Mann-Whitney U test, as appropriate.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.05|<|0.05||95.0|||||Chi-squared|Test selection was based on evaluating the variables for normal distribution employing the Kolmogorov-Smirnov test.||"The sample size of n=120 was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.~Because measurements were made several times on the same patients within in two independent groups, GLM Repeated Measurement procedure was applied to test null hypotheses about the effects of both the between-subject factor (study group) and the within-subject factor (time)."||||<0.05
73966329|NCT04840199|147468871|SUPERIORITY||Mean Difference (Net)|0.0009||||0.72|TWO_SIDED|95.0|-0.004|0.0058||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Early treatment phase comparison||0.0058|-0.0040|0.72
73966330|NCT04840199|147468871|SUPERIORITY||Mean Difference (Net)|-0.0009||||0.13|TWO_SIDED|95.0|-0.0022|0.0003||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Late treatment phase comparison||0.0003|-0.0022|0.13
74027409|NCT00685178|147607880|SUPERIORITY||Spearmann's rank correlation|0.494|||<|0.001|TWO_SIDED||||||Generalized Estimating Equation (GEE)||NonCR subjects only|Analyses were performed to measure the correlation between Non-CR groups (topiramate + NonCR and Placebo + NonCR) and abstinence.||||<0.001
74027410|NCT00984659|147607905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.713|TWO_SIDED|95.0|-0.03|0.05|||t-test, 2 sided|||||0.05|-0.03|0.713
74027411|NCT00984659|147607909|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Analysis of covariance (ANCOVA) adjusted for age, gender, and percent predicted Forced Expiratory volume in one second (FEV1) at Screening.|ANCOVA|||||||<0.001
74027412|NCT00984659|147607910|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening.|ANCOVA|||||||<0.001
74027413|NCT00984659|147607911|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening|ANCOVA|||||||0.008
74027414|NCT00984659|147607913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.18|0.31||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 8|ANCOVA|||||0.31|0.18|<0.001
74027415|NCT00984659|147607913|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12|||<|0.001||95.0|0.06|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 15|ANCOVA|||||0.19|0.06|<0.001
74027416|NCT00984659|147607913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.16||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 22|ANCOVA|||||0.16|0.06|<0.001
74086055|NCT00442546|147725977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.463|STANDARD_ERROR_OF_MEAN|0.388||0.2367||95.0|-0.311|1.237|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.237|-0.311|0.2367
74086056|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.064|STANDARD_ERROR_OF_MEAN|0.448||0.8868||95.0|-0.947|0.82|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.820|-0.947|0.8868
73916316|NCT01233258|147361803|SUPERIORITY_OR_OTHER|||||||0.0001||||||No multiplicity adjustment as only 1 primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation: Assumption 5 bleeds per year on prophylactic treatment, 15 on on-demand treatment; 2-sided alpha 5% and 90% power.||||0.0001
74027417|NCT00984659|147607913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.17||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 29|ANCOVA|||||0.17|0.06|<0.001
74027418|NCT00984659|147607913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.001||95.0|0.08|0.18||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 36|ANCOVA|||||0.18|0.08|<0.001
74027419|NCT00984659|147607913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.18||95.0|-0.03|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 43|ANCOVA|||||0.15|-0.03|0.180
74027420|NCT00984659|147607913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.307||95.0|-0.07|0.23||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Visit 3/PD|ANCOVA|||||0.23|-0.07|0.307
74027421|NCT00984659|147607917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.14|0.34||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CGI-C responders and non-responders|ANCOVA|||||0.34|0.14|<0.001
74086057|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.254|STANDARD_ERROR_OF_MEAN|0.45||0.5733||95.0|-1.142|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.634|-1.142|0.5733
74086058|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.384||0.7385||95.0|-0.884|0.628|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.628|-0.884|0.7385
73966331|NCT04840199|147468871|SUPERIORITY||Mean Difference (Net)|0.0023||||0.17|TWO_SIDED|95.0|-0.001|0.0055||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Post treatment phase comparison||0.0055|-0.0010|0.17
73966332|NCT04143061|147468872|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|6.55|||||TWO_SIDED|95.0|2.03|11.08||||||Statistical analysis for Serogroup A||11.08|2.03|
74027422|NCT00984659|147607918|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3|||<|0.001|TWO_SIDED|95.0|0.21|0.4||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CRQ-SAS Dyspnea Domain responders and non-responders|ANCOVA|||||0.40|0.21|<0.001
74027423|NCT00984659|147607919|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.535||95.0|-0.08|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for Physician-Completed mMRC responders and non-responders|ANCOVA|||||0.15|-0.08|0.535
73860212|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4852||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.4852
73860213|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5879||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.5879
73860214|NCT00468845|147266457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7699||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.7699
73860215|NCT00468845|147266458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9676||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.9676
73966333|NCT04143061|147468872|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|21.67|||||TWO_SIDED|95.0|17.82|25.8||||||Statistical analysis for Serogroup C||25.80|17.82|
73966334|NCT04143061|147468872|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|11.08|||||TWO_SIDED|95.0|7.43|14.89||||||Statistical analysis for Serogroup Y||14.89|7.43|
73966335|NCT04143061|147468872|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|11.01|||||TWO_SIDED|95.0|7.86|14.47||||||Statistical analysis for Serogroup W||14.47|7.86|
73966336|NCT02488863|147468886|OTHER|ANOVA||||||0.0561|||||||ANOVA|||H0: mean(SPPB\_older\_pain) = mean(SPPB\_older\_no pain) = mean(SPPB\_younger)||||0.0561
73966337|NCT06023082|147468905|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966338|NCT06023082|147468906|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
73966339|NCT06023082|147468907|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966340|NCT06023082|147468908|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966341|NCT06023082|147468909|OTHER|||||||0.4907||||||Baseline to Week 12 comparison.|ANOVA|||||||0.4907
73966342|NCT06023082|147468910|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966343|NCT06023082|147468911|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966344|NCT06023082|147468912|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966345|NCT06023082|147468913|OTHER|||||||0.0016||||||Baseline to Week 12 comparison.|ANOVA|||||||0.0016
73966346|NCT06023082|147468914|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966347|NCT06023082|147468915|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966348|NCT06023082|147468916|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966349|NCT06023082|147468917|OTHER|||||||0.0002||||||Baseline to Week 12 comparison.|ANOVA|||||||0.0002
73966350|NCT06023082|147468918|OTHER|||||||0.001||||||Baseline to Week 12 comparison.|ANOVA|||||||0.001
73966351|NCT06023082|147468919|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966352|NCT06023082|147468920|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966353|NCT06023082|147468921|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966354|NCT06023082|147468922|OTHER||||||<|0.0001|||||||ANOVA|||Baseline to Week 12 comparison.||||<0.0001
73966355|NCT06023082|147468923|OTHER||||||<|0.0001||||||Baseline to Week 10 comparison.|ANOVA|||||||<0.0001
73966356|NCT06023082|147468924|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966357|NCT06023082|147468925|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966358|NCT06023082|147468926|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966359|NCT06023082|147468927|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
73966360|NCT04899115|147468972|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
73966361|NCT04899115|147468973|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|Wilcoxon was used because data was not normal.||||||0.48
73966362|NCT05767437|147469020|EQUIVALENCE|effect size of 0.02, α \< 0.05, power = 0.02|Mean Difference (Net)|1.63||||0.98|TWO_SIDED|95.0|-55.79|59.05|||Mixed Models Analysis|||||59.05|-55.79|0.98
73966363|NCT05767437|147469021|EQUIVALENCE|an effect size of 0.00, α \< 0.05, power = 0.00|Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-1.25|1.24|||Mixed Models Analysis|||||1.24|-1.25|0.99
74027424|NCT00984659|147607919|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.08||95.0|-0.02|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparison of mean SOBDA score for Participant-Completed mMRC responders and non-responders|ANCOVA|||||0.19|-0.02|0.08
73860216|NCT00468845|147266458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4944||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4944
73860217|NCT00468845|147266459|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4801||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4801
73860218|NCT00468845|147266459|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8832||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.8832
73860219|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2125||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hours PS||||0.2125
73860220|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7602||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hour PS||||0.7602
73860221|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4053||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS||||0.4053
73860222|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4147||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS||||0.4147
73860223|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5556||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.5556
73860224|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.482||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.4820
73860225|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5088||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS||||0.5088
73860226|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS||||0.3900
73860227|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9659||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS||||0.9659
73860228|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3968||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS||||0.3968
73860229|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8308||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.8308
73860230|NCT00468845|147266460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0902||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.0902
73860231|NCT00468845|147266461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4388||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4388
73860232|NCT00468845|147266461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3364||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.3364
73860233|NCT00468845|147266462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2409||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.2409
73860234|NCT00468845|147266462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1654||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.1654
73860235|NCT00468845|147266462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.1110
73860236|NCT00468845|147266462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0598||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.0598
73860237|NCT00468845|147266462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0398||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.0398
73860238|NCT00468845|147266462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0623||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.0623
73860239|NCT00468845|147266463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS||||0.2730
73860240|NCT00468845|147266463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1015||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS||||0.1015
73860241|NCT00468845|147266463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2438||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS||||0.2438
73860242|NCT00468845|147266463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0102||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS||||0.0102
73860243|NCT00468845|147266463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2063||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS||||0.2063
73860244|NCT00468845|147266463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0387||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS||||0.0387
73860245|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5995||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5995
73966364|NCT05767437|147469022|EQUIVALENCE|an effect size of 0.56 , α \< 0.05, power = 32.5|Mean Difference (Net)|6.71||||0.68|TWO_SIDED|95.0|-24.12|10.71|||Mixed Models Analysis|||||10.71|-24.12|0.68
73966365|NCT05767437|147469023|EQUIVALENCE|Analysis population description: patients were randomly assigned to either Group A or Group B|Mean Difference (Net)|0.2||||0.56|TWO_SIDED|95.0|-0.48|0.87|||Mixed Models Analysis|||an effect size of 0.24, α \< 0.05, power = 24.5||0.87|-0.48|0.56
74027425|NCT01515072|147607954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.38|TWO_SIDED|95.0|-0.37|0.21||This is an unadjusted comparison. P value \< 0.05|t-test, 2 sided|Adjusted analyses for the RIPC effect are provided below.|0.08 less organs per donor in the RIPC group.|Sample Size and Power estimation: A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.||0.21|-0.37|0.38
74027426|NCT01515072|147607955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.7|TWO_SIDED|95.0|-0.33|0.26||This is an unadjusted analysis. P \< 0.05|t-test, 2 sided|Adjusted analyses are provided below.|0.03 less organs per donor in the RIPC group.|Sample Size A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.||0.26|-0.33|0.70
74027427|NCT01515072|147607956|SUPERIORITY_OR_OTHER|||||||0.63||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.63
74027428|NCT01515072|147607957|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
74027429|NCT01515072|147607958|SUPERIORITY_OR_OTHER|||||||0.55||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.55
74027430|NCT01515072|147607959|SUPERIORITY_OR_OTHER|||||||0.55||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.55
74027431|NCT01515072|147607960|SUPERIORITY_OR_OTHER|||||||0.48||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.48
74027432|NCT01515072|147607961|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.04
74086059|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.39||0.8353||95.0|-0.849|0.687|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.687|-0.849|0.8353
74086060|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.362||0.5737||95.0|-0.51|0.918|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.918|-0.510|0.5737
73860246|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.9104
73860247|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2177||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.2177
73860248|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.1770
73860249|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1229||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.1229
73860250|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1274||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.1274
73860251|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0568||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.0568
73860252|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0354||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.0354
73860253|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4269||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.4269
73860254|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2058||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.2058
73860255|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8215||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.8215
73860256|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5331||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.5331
73860257|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7365||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.7365
73860258|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9989||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.9989
73860259|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2501||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.2501
74027433|NCT01515072|147607962|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.7||||0.53|TWO_SIDED|95.0|-10.1|19.5||P\<0.05|Regression, Linear|Final flow was modeled on RIPC and adjusted for donor stratum and duration of perfusion|Data shown above is the the adjusted mean difference in final flow in RIPC group|||19.5|-10.1|0.53
74027434|NCT01515072|147607963|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
74027435|NCT01515072|147607964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.07|TWO_SIDED|95.0|0.95|2.76||Adjusted analysis with recipient age as a continuous variable, sex, race as black versus not black, body mass index, diabetes, hypertension,antigen mismatches, donor age as a continuous variable and trial site.|Chi-squared|||||2.76|0.95|0.07
74027436|NCT01515072|147607964|SUPERIORITY_OR_OTHER|||||||0.36||||||Unadjusted analysis|Chi-squared|||||||0.36
74086061|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.335|STANDARD_ERROR_OF_MEAN|0.368||0.364||95.0|-1.06|0.391|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.391|-1.060|0.3640
74086062|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.332||0.4315||95.0|-0.393|0.917|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.917|-0.393|0.4315
73860260|NCT00468845|147266464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6021||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.6021
73860261|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6613||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)||||0.6613
73860262|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1311||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)||||0.1311
73860263|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6574||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)||||0.6574
73860264|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6949||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)||||0.6949
73860265|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2008||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.2008
74027437|NCT01515072|147607965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.006|TWO_SIDED|95.0|0.03|0.17|||Regression, Linear|Final resistance was modeled on RIPC and adjusted for donor stratum and duration of perfusion.|Data shown above is the adjusted mean difference in final resistance in the RIPC group.|||0.17|0.03|0.006
74027438|NCT01515072|147607966|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|This is an unadjusted comparison||||||0.50
74027439|NCT01515072|147607967|SUPERIORITY_OR_OTHER|||||||0.03|||||||Log Rank|This is an unadjusted comparison||||||0.03
74027440|NCT01515072|147607968|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.19||||0.01|TWO_SIDED|95.0|0.04|0.9|||Log Rank|Results of adjusted Cox proportional hazard analyses for six month death-censored kidney graft survival are shown below|The proportional hazard ratio favors RIPC group|||0.90|0.04|0.01
74027441|NCT01515072|147607969|SUPERIORITY_OR_OTHER|||||||0.37|||||||Log Rank|This is an unadjusted comparison||||||0.37
74027442|NCT01508676|147607970|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||.04
74027443|NCT02532543|147607973|SUPERIORITY|||||||0.863|||||||ANOVA|||||||0.863
74027444|NCT02532543|147607974|SUPERIORITY|||||||0.718|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest||||0.718
74027445|NCT02532543|147607974|SUPERIORITY|||||||0.853|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest||||0.853
74027446|NCT02532543|147607975|SUPERIORITY|||||||0.718|||||||ANOVA|||Comparison between each arm/group of change in mid buccal bone height||||0.718
74027447|NCT02532543|147607975|SUPERIORITY|||||||0.999|||||||ANOVA|||Comparison between each arm/group of change in mid palatal bone height||||0.999
74027448|NCT02532543|147607975|SUPERIORITY|||||||0.44|||||||ANOVA|||Comparison between each arm/group of change in mesial bone height||||0.440
74027449|NCT02532543|147607975|SUPERIORITY|||||||0.729|||||||ANOVA|||Comparison between each arm/group of change in distal bone height||||0.729
74027450|NCT02532543|147607976|SUPERIORITY|||||||0.613|||||||ANOVA|||||||0.613
74027451|NCT02532543|147607977|SUPERIORITY|||||||0.492|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest||||0.492
74027452|NCT02532543|147607977|SUPERIORITY|||||||0.917|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest||||0.917
74027453|NCT02532543|147607978|SUPERIORITY|||||||0.353|||||||ANOVA|||Comparison between each arm/group of change in mid buccal soft tissue height||||0.353
74027454|NCT02532543|147607978|SUPERIORITY|||||||0.823|||||||ANOVA|||Comparison between each arm/group of change in mid palatal soft tissue height||||0.823
74027455|NCT02532543|147607978|SUPERIORITY|||||||0.243|||||||ANOVA|||Comparison between each arm/group of change in mesial soft tissue height||||0.243
74027456|NCT02532543|147607978|SUPERIORITY|||||||0.756|||||||ANOVA|||Comparison between each arm/group of change in distal soft tissue height||||0.756
74027457|NCT00609128|147607980|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|ANOVA with preplanned comparisons was used to generate two tailed P values. Paired t tests were used to make appropriate post-ANOVA comparisons.||"tears were collected in season from eyes of allergic patients with or without olopatadine treatment, that is one eye was treated and the patients other eye was not.~Tears from each patient's eyes were pooled to provide enough volume."||||<0.05
74027458|NCT00923091|147607992|SUPERIORITY_OR_OTHER|||||||0.0071||95.0|||||ANCOVA|||||||0.0071
74027459|NCT00923091|147607992|SUPERIORITY_OR_OTHER|||||||0.0323||95.0|||||ANCOVA|||||||0.0323
74027460|NCT00923091|147607992|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|||||||0.0080
74027461|NCT00923091|147607992|SUPERIORITY_OR_OTHER|||||||0.0071||95.0|||||ANCOVA|||||||0.0071
74027462|NCT00923091|147607992|SUPERIORITY_OR_OTHER|||||||0.0107||95.0|||||ANCOVA|||||||0.0107
74027463|NCT00923091|147607993|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
74027464|NCT00923091|147607993|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||||||0.0008
74027465|NCT00923091|147607993|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74027466|NCT00923091|147607993|SUPERIORITY_OR_OTHER|||||||0.0034||95.0|||||ANCOVA|||||||0.0034
74027467|NCT00923091|147607993|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
74027468|NCT00923091|147607994|SUPERIORITY_OR_OTHER|||||||0.0295||95.0|||||Cochran-Mantel-Haenszel|||||||0.0295
74027469|NCT00923091|147607994|SUPERIORITY_OR_OTHER|||||||0.2529||95.0|||||Cochran-Mantel-Haenszel|||||||0.2529
74027470|NCT00923091|147607994|SUPERIORITY_OR_OTHER|||||||0.0037||95.0|||||Cochran-Mantel-Haenszel|||||||0.0037
74027471|NCT00923091|147607994|SUPERIORITY_OR_OTHER|||||||0.2033||95.0|||||Cochran-Mantel-Haenszel|||||||0.2033
74027472|NCT00923091|147607994|SUPERIORITY_OR_OTHER|||||||0.2529||95.0|||||Cochran-Mantel-Haenszel|||||||0.2529
74027473|NCT00923091|147607995|SUPERIORITY_OR_OTHER|||||||0.1135||95.0|||||ANCOVA|||||||0.1135
74027474|NCT00923091|147607996|SUPERIORITY_OR_OTHER|||||||0.2765||95.0|||||ANCOVA|||||||0.2765
74027475|NCT00923091|147607997|SUPERIORITY_OR_OTHER|||||||0.4964||95.0|||||Cochran-Mantel-Haenszel|||||||0.4964
74027476|NCT00923091|147607998|SUPERIORITY_OR_OTHER|||||||0.1301||95.0|||||ANCOVA|||||||0.1301
74027477|NCT00923091|147607998|SUPERIORITY_OR_OTHER|||||||0.01301||95.0|||||ANCOVA|||||||0.01301
74027478|NCT00923091|147607999|SUPERIORITY_OR_OTHER|||||||0.0503||95.0|||||ANCOVA|||||||0.0503
74027479|NCT00467649|147608002|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Fisher Exact|||||||0.0180
73916317|NCT01233258|147361804|SUPERIORITY_OR_OTHER|||||||0.0001||||||No multiplicity adjustment as this is not primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.||||0.0001
73916318|NCT01233258|147361805|SUPERIORITY_OR_OTHER|||||||0.0001|||||||ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.||||0.0001
73916319|NCT01233258|147361806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 10%|Median Difference (Net)|-0.0001||||0.0001|ONE_SIDED|95.0|-0.049|||No multiplicity adjustment as not primary endpoint.|Exact Permutation Test for paired sample||Confidence interval calculated with exact Hodges- Lehmann estimates for CS/EP minus CS/ADJ|Null hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is less than the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. Alternative hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is greater than or equal to the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. No power calculation since this is not the primary comparison.|||-0.0490|0.0001
73916320|NCT01049308|147361809|SUPERIORITY_OR_OTHER||percentage|57.6|||||TWO_SIDED|||||||||Descriptive data to describe prevalence of cognitive impairment in outpatient veterans with chronic heart failure||||
73916321|NCT00545662|147361813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.76|TWO_SIDED|95.0|0.83|1.14||a priori threshold for statistical significance is 0.05|Regression, Logistic|Logistic regression estimated global OR. GEE accounted for correlations of the scales. Models adjusted for site \& injury severity.|The odds in the citicoline group were compared to the odds in the placebo group.|"Null hypothesis: The placebo and citicoline groups do not differ at 90-days on the Core Battery~Power:~1. Two sided type I error of 0.05~2. 85% power~3. Expected OR=1.40 for the global statistic~4. Response rate in the control group~5. Correlations among the nine measures were accounted for. Response rates for the whole sample were a weighted average of the rates provided by TBI severity.~1240 participants were required to detect an OR \>= 1.4 for the global statistic."||1.14|0.83|0.76
73916322|NCT03926169|147361814|SUPERIORITY||Adjusted Response Rate Difference (%)|6.0||||0.422|TWO_SIDED|97.5|-10.8|22.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||22.8|-10.8|0.422
73916323|NCT03926169|147361814|SUPERIORITY||Adjusted Response Rate Difference (%)|1.3||||0.858|TWO_SIDED|97.5|-15.4|18.1||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||18.1|-15.4|0.858
73916324|NCT03926169|147361815|SUPERIORITY||Adjusted Response Rate Difference (%)|-3.0||||0.725|TWO_SIDED|97.5|-21.8|15.9||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||15.9|-21.8|0.725
73916325|NCT03926169|147361815|SUPERIORITY||Adjusted Response Rate Difference (%)|8.8||||0.301|TWO_SIDED|97.5|-10.3|27.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||27.8|-10.3|0.301
73916326|NCT03926169|147361816|SUPERIORITY||Adjusted Response Rate Difference (%)|3.7||||0.65|TWO_SIDED|97.5|-14.5|21.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||21.8|-14.5|0.650
73966366|NCT05767437|147469024|EQUIVALENCE|an effect size of 0.56, α \< 0.05, power = 57.9|Mean Difference (Net)|-250.35||||0.42|TWO_SIDED|95.0|-614.88|114.18||Interaction of Assessment and Group|Mixed Models Analysis|||||114.18|-614.88|0.42
74086063|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.339||0.6727||95.0|-0.525|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.812|-0.525|0.6727
73916327|NCT03926169|147361816|SUPERIORITY||Adjusted Response Rate Difference (%)|12.3||||0.147|TWO_SIDED|97.5|-6.7|31.3||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||31.3|-6.7|0.147
73916328|NCT03926169|147361817|SUPERIORITY||Adjusted Response Rate Difference (%)|-6.5||||0.342|TWO_SIDED|97.5|-21.8|8.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||8.8|-21.8|0.342
73916329|NCT03926169|147361817|SUPERIORITY||Adjusted Response Rate Difference (%)|-10.6||||0.108|TWO_SIDED|97.5|-25.3|4.2||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||4.2|-25.3|0.108
73916330|NCT03926169|147361818|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.97||0.179|TWO_SIDED|97.5|-3.5|0.9||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.9|-3.5|0.179
73966367|NCT05767437|147469025|EQUIVALENCE|an effect size of 0.29, α \< 0.05, power = 88.9|Mean Difference (Net)|12.25||||0.45|TWO_SIDED|95.0|-18.67|43.17|||Mixed Models Analysis|||||43.17|-18.67|0.45
73966368|NCT05767437|147469026|EQUIVALENCE|an effect size of 0.18, α \< 0.05, power =6.5|mean rank (Z)|0.18||||0.67|TWO_SIDED|95.0|-0.61|0.96||MAS of Biceps|Wilcoxon (Mann-Whitney)|||||0.96|-0.61|0.67
74086064|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.489|STANDARD_ERROR_OF_MEAN|0.505||0.3361||95.0|-1.496|0.517|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.517|-1.496|0.3361
73860266|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.3022
73916331|NCT03926169|147361818|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.98||0.105|TWO_SIDED|97.5|-3.8|0.6||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.6|-3.8|0.105
73916332|NCT03926169|147361819|SUPERIORITY||LS Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.3385||0.727|TWO_SIDED|97.5|-0.646|0.883||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.883|-0.646|0.727
73916333|NCT03926169|147361819|SUPERIORITY||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.3273||0.963|TWO_SIDED|97.5|-0.755|0.724||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.724|-0.755|0.963
73916334|NCT03926169|147361820|SUPERIORITY||LS Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.2941||0.886|TWO_SIDED|97.5|-0.622|0.706||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.706|-0.622|0.886
73916335|NCT03926169|147361820|SUPERIORITY||LS Mean Difference|0.236|STANDARD_ERROR_OF_MEAN|0.2851||0.409|TWO_SIDED|97.5|-0.408|0.879||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.879|-0.408|0.409
73916336|NCT03926169|147361821|SUPERIORITY||LS Mean Difference|-0.252|STANDARD_ERROR_OF_MEAN|0.3212||0.434|TWO_SIDED|97.5|-0.977|0.473||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.473|-0.977|0.434
73916337|NCT03926169|147361821|SUPERIORITY||LS Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.3123||0.813|TWO_SIDED|97.5|-0.779|0.631||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.631|-0.779|0.813
73916338|NCT00006237|147361842|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Log Rank|||||||0.49
73916339|NCT00006237|147361843|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|||||||0.02
73860267|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6382||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.6382
73860268|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8624||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.8624
73860269|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3858||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.3858
73860270|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4814||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4814
73860271|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.952||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.9520
73860272|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2315||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.2315
73860273|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7061||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.7061
73860274|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2908||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.2908
73916340|NCT02207244|147361862|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
73916341|NCT02207244|147361863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
73916342|NCT02207244|147361864|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
73916343|NCT02207244|147361865|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
73916344|NCT02207244|147361866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
73916345|NCT02207244|147361867|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Log Rank|||p value is based on the log-rank test stratified by investigator site (pooled).||||< 0.001
73916346|NCT02207244|147361868|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).||||< 0.001
73916347|NCT02207244|147361869|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10.0%|Difference in Percentage|16.4|||<|0.001|TWO_SIDED|95.0|10.0|23.2|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).||23.2|10.0|< 0.001
73916348|NCT02207244|147361869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
73916349|NCT02207244|147361870|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10.0%|Difference in Percentage|23.3|||<|0.001|TWO_SIDED|95.0|16.0|30.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||30.4|16.0|< 0.001
73916350|NCT02207244|147361870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
73916351|NCT02207244|147361871|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10%|Difference in percentage|17.7|||<|0.001|TWO_SIDED|95.0|11.4|24.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||24.4|11.4|< 0.001
73966369|NCT05767437|147469027|EQUIVALENCE|an effect size of 0.39, α \< 0.05, power = 16.2|Mean Difference (Net)|-6.63||||0.38|TWO_SIDED|95.0|-19.38|6.12|||t-test, 2 sided|||||6.12|-19.38|0.38
73966370|NCT05384730|147469032|SUPERIORITY|||||||0.1|||||||ANOVA|||Light physical activity compared overtime||||0.10
73966371|NCT05384730|147469032|SUPERIORITY|||||||0.3|||||||ANOVA|||Moderate-vigorous physical activity compared overtime||||0.30
73966372|NCT05384730|147469032|SUPERIORITY|||||||0.18|||||||ANOVA|||Inactive/sedentary time compared overtime||||0.18
73966373|NCT05384730|147469033|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
73966374|NCT05384730|147469034|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
73966375|NCT05384730|147469035|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.50
73966376|NCT05384730|147469036|SUPERIORITY|||||||0.03|||||||Chi-squared|||Comparing depression scores overtime||||0.03
73966377|NCT05384730|147469036|SUPERIORITY|||||||0.96|||||||Chi-squared|||Comparing anxiety scores overtime||||0.96
73860275|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4782||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.4782
73860276|NCT00468845|147266465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.813||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.8130
73966378|NCT05384730|147469037|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
74027480|NCT00995371|147608052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52|||<|0.05|TWO_SIDED|95.0|1.09|3.96|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||3.96|1.09|<0.05
74027481|NCT00995371|147608052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||>|0.05|TWO_SIDED|95.0|-1.43|1.55|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||1.55|-1.43|>0.05
73860277|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.894||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8940
73860278|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5938||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5938
73860279|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4306||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.4306
73860280|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5899||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.5899
73860281|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2209||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2209
73860282|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7145||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.7145
73860283|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.1022
73860284|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7243||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.7243
73860285|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.2310
73860286|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9192||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.9192
73860287|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.3214
73860288|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8641||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.8641
73860289|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3024||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.3024
73860290|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7359||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.7359
73860291|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.4303
73860292|NCT00468845|147266466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2133||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.2133
73860293|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5682||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS||||0.5682
73860294|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1005||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS||||0.1005
73860295|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8261||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS||||0.8261
73860296|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9981||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS||||0.9981
73860297|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8884||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8884
73860298|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4507||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.4507
73966379|NCT05384730|147469038|SUPERIORITY|||||||0.13|||||||ANOVA|||||||0.13
73966380|NCT05384730|147469039|SUPERIORITY|||||||0.01|||||||ANOVA|||PASE analysis over time||||0.01
74086065|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.469||0.9634||95.0|-0.955|0.912|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.912|-0.955|0.9634
74086066|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.446|STANDARD_ERROR_OF_MEAN|0.352||0.2098||95.0|-0.257|1.15|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.150|-0.257|0.2098
74086067|NCT00442546|147725978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.382||0.49||95.0|-0.497|1.027|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.027|-0.497|0.4900
74086068|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.546||0.9912||95.0|-1.07|1.082|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||1.082|-1.070|0.9912
74086069|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.554||0.8076||95.0|-1.227|0.957|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.957|-1.227|0.8076
74086070|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.46||0.6978||95.0|-0.727|1.085|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.085|-0.727|0.6978
74086071|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.47||0.5344||95.0|-1.219|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.634|-1.219|0.5344
74086072|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.384||0.8721||95.0|-0.819|0.695|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.695|-0.819|0.8721
74086073|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.395|STANDARD_ERROR_OF_MEAN|0.394||0.3179||95.0|-1.173|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.383|-1.173|0.3179
74086074|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.376||0.8037||95.0|-0.648|0.835|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.835|-0.648|0.8037
74086075|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.39||0.7731||95.0|-0.656|0.881|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.881|-0.656|0.7731
74086076|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.468|STANDARD_ERROR_OF_MEAN|0.611||0.4461||95.0|-1.684|0.748|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.748|-1.684|0.4461
73916352|NCT02207244|147361871|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
73916353|NCT02207244|147361872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
74086077|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.575||0.3568||95.0|-1.679|0.612|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.612|-1.679|0.3568
74086078|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.598|STANDARD_ERROR_OF_MEAN|0.315||0.0623||95.0|-0.032|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.227|-0.032|0.0623
74086079|NCT00442546|147725979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.343||0.3529||95.0|-0.364|1.005|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.005|-0.364|0.3529
73916354|NCT02207244|147361873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).||||< 0.001
74086080|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.611|STANDARD_ERROR_OF_MEAN|0.417||0.1448||95.0|-1.434|0.212|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.212|-1.434|0.1448
74086081|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.665|STANDARD_ERROR_OF_MEAN|0.42||0.1148||95.0|-1.494|0.163|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.163|-1.494|0.1148
74086082|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.448|STANDARD_ERROR_OF_MEAN|0.458||0.3285||95.0|-1.35|0.454|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.454|-1.350|0.3285
74086083|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.572|STANDARD_ERROR_OF_MEAN|0.466||0.2205||95.0|-1.49|0.346|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.346|-1.490|0.2205
74086084|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.389||0.6266||95.0|-0.958|0.578|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.578|-0.958|0.6266
74086085|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.502|STANDARD_ERROR_OF_MEAN|0.397||0.2077||95.0|-1.284|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.281|-1.284|0.2077
74086086|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.223|STANDARD_ERROR_OF_MEAN|0.385||0.5626||95.0|-0.982|0.536|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.536|-0.982|0.5626
74086087|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.368|STANDARD_ERROR_OF_MEAN|0.394||0.3507||95.0|-1.145|0.408|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.408|-1.145|0.3507
73916355|NCT02207244|147361874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
73916356|NCT02854631|147361902|SUPERIORITY|||||||1|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||1.00
73916357|NCT02854631|147361903|SUPERIORITY|||||||0.061|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||0.061
73916358|NCT02854631|147361904|SUPERIORITY|||||||0.06|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||0.060
73860299|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2994||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS||||0.2994
73860300|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4371||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS||||0.4371
73860301|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8295||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS||||0.8295
73916359|NCT02854631|147361905|SUPERIORITY|||||||0.22||||||P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.|Fisher Exact|||||||0.22
73916360|NCT02854631|147361921|SUPERIORITY|||||||0.3|||||||Fisher Exact|Fisher's exact test (2-sided) was used to explore differences between groups in the percentage of participants with response/non-response.||||||0.30
73916361|NCT03200860|147361928|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
73916362|NCT03200860|147361929|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
73916363|NCT03200860|147361930|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
73916364|NCT03200860|147361931|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
73916365|NCT03200860|147361932|SUPERIORITY|||||||0.31|||||||Regression, Logistic|||||||0.31
73916366|NCT03200860|147361933|SUPERIORITY|||||||0.014|||||||Regression, Logistic|||||||0.014
73916367|NCT02634320|147361948|OTHER|Statistical test is to confirm the change from baseline is statistically different from 0.||||||0.078||||||Change from baseline at last on-treatment visit|t-test, 2 sided|||||||0.078
73916368|NCT03919799|147361956|SUPERIORITY|The LOCF imputation was followed by logistic regression analysis. Comparison analysis between belumosudil dose regimen and placebo was performed using a logistic regression analysis with treatment in the model.|Odds Ratio (OR)|1.06||||0.9472|TWO_SIDED|95.0|0.19|5.82||Threshold for significance at 0.05 level.|Regression, Logistic|||Belumosudil 200 mg QD versus Placebo||5.82|0.19|0.9472
73916369|NCT03919799|147361956|SUPERIORITY|The LOCF imputation was followed by logistic regression analysis. Comparison analysis between belumosudil dose regimen and placebo was performed using a logistic regression analysis with treatment in the model.|Odds Ratio (OR)|0.39||||0.3078|TWO_SIDED|95.0|0.07|2.35||Threshold for significance at 0.05 level.|Regression, Logistic|||Belumosudil 200 mg BID versus Placebo||2.35|0.07|0.3078
73916370|NCT03919799|147361957|SUPERIORITY|MMRM analysis used rank-transformed data, with CRISS score as a dependent variable and treatment, visit, and visit x treatment interaction as fixed effects. Visit was a repeated factor, and analyses were done through week 24.|Least square mean difference|-0.04||||0.9889|TWO_SIDED|95.0|-6.51|6.42||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||6.42|-6.51|0.9889
73916371|NCT03919799|147361957|SUPERIORITY|MMRM analysis using rank-transformed data, with CRISS score as a dependent variable and treatment, visit, and visit x treatment interaction as fixed effects. Visit was a repeated factor, and analyses were done through week 24.|Least square mean difference|-4.18||||0.1916|TWO_SIDED|95.0|-10.59|2.23||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||2.23|-10.59|0.1916
73916372|NCT03919799|147361959|SUPERIORITY||Least square mean difference|-0.6||||0.771|TWO_SIDED|95.0|-4.7|3.6||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||3.6|-4.7|0.7710
73916373|NCT03919799|147361959|SUPERIORITY||Least square mean difference|4.6||||0.0308|TWO_SIDED|95.0|0.5|8.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||8.8|0.5|0.0308
73916374|NCT03919799|147361960|SUPERIORITY||Least square mean difference|1.4||||0.6533|TWO_SIDED|95.0|-4.9|7.7||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||7.7|-4.9|0.6533
73916375|NCT03919799|147361960|SUPERIORITY||Least square mean difference|-1.5||||0.6338|TWO_SIDED|95.0|-8.1|5.0||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||5.0|-8.1|0.6338
73916376|NCT03919799|147361961|SUPERIORITY||Least square mean difference|14.6||||0.0916|TWO_SIDED|95.0|-2.5|31.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||31.8|-2.5|0.0916
73860302|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8783||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS||||0.8783
73860303|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2161||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.2161
73860304|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.0440
73916377|NCT03919799|147361961|SUPERIORITY||Least square mean difference|-8.6||||0.3146|TWO_SIDED|95.0|-25.7|8.6|||MMRM|||Belumosudil 200 mg BID versus Placebo||8.6|-25.7|0.3146
73916378|NCT03919799|147361962|SUPERIORITY||Least square mean difference|-10.0||||0.3753|TWO_SIDED|95.0|-32.8|12.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||12.8|-32.8|0.3753
73916379|NCT03919799|147361962|SUPERIORITY||Least square mean difference|-0.7||||0.9481|TWO_SIDED|95.0|-23.5|22.1||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||22.1|-23.5|0.9481
73916380|NCT03919799|147361963|SUPERIORITY||Least square mean difference|-0.036||||0.8387|TWO_SIDED|95.0|-0.392|0.32||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||0.320|-0.392|0.8387
73916381|NCT03919799|147361963|SUPERIORITY||Least square mean difference|0.039||||0.8234|TWO_SIDED|95.0|-0.317|0.395||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||0.395|-0.317|0.8234
73916382|NCT03919799|147361964|SUPERIORITY||Least square mean difference|-3.009||||0.7535|TWO_SIDED|95.0|-22.413|16.395||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||16.395|-22.413|0.7535
73916383|NCT03919799|147361964|SUPERIORITY||Least square mean difference|-21.015||||0.0348|TWO_SIDED|95.0|-40.419|-1.611||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||-1.611|-40.419|0.0348
73916384|NCT03919799|147361965|SUPERIORITY||Least square mean difference|45.566||||0.0343|TWO_SIDED|95.0|3.621|87.512||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||87.512|3.621|0.0343
73916385|NCT03919799|147361965|SUPERIORITY||Least square mean difference|-21.984||||0.2922|TWO_SIDED|95.0|-63.93|19.962||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||19.962|-63.930|0.2922
73916386|NCT03919799|147361966|SUPERIORITY||Least square mean difference|-16.757||||0.532|TWO_SIDED|95.0|-70.933|37.419||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||37.419|-70.933|0.5320
73916387|NCT03919799|147361966|SUPERIORITY||Least square mean difference|4.02||||0.8804|TWO_SIDED|95.0|-50.156|58.196||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||58.196|-50.156|0.8804
73916388|NCT03919799|147361967|SUPERIORITY||Least square mean difference|7.522||||0.8628|TWO_SIDED|95.0|-80.837|95.88||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||95.880|-80.837|0.8628
73916389|NCT03919799|147361967|SUPERIORITY||Least square mean difference|-42.442||||0.3196|TWO_SIDED|95.0|-128.242|43.359|||MMRM|||Belumosudil 200 mg BID versus Placebo||43.359|-128.242|0.3196
73916390|NCT02970422|147362027|OTHER|||||||0.91|||||||Chi-squared|Chi-squared value= .57||Relief of breathlessness||||.91
73916391|NCT02970422|147362027|OTHER|||||||0.31|||||||Chi-squared|Chi-squared value= 3.56||Improve your ability to perform activities in and out of your home||||.31
74027482|NCT00995371|147608053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.33|||<|0.05|TWO_SIDED|95.0|3.35|19.31|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||19.31|3.35|<0.05
73916392|NCT02970422|147362027|OTHER|||||||0.96|||||||Chi-squared|Chi-squared value=.32||Prevent lung flare-ups||||.96
73916393|NCT02970422|147362027|OTHER|||||||0.04|||||||Chi-squared|Chi-squared value= 8.09||Discuss COPD and its progression||||.04
73916394|NCT02970422|147362027|OTHER|||||||0.7|||||||Chi-squared|Chi-squared value: 1.41||Improve your physical well-being||||.70
73916395|NCT02970422|147362027|OTHER|||||||0.01|||||||Chi-squared|Chi-squared value= 10.81||Relief of breathlessness||||.01
73916396|NCT02970422|147362027|OTHER|||||||0.49|||||||Chi-squared|Chi-squared value= 2.41||Improve your ability to perform activities in and out of your home||||.49
73916397|NCT02970422|147362027|OTHER|||||||0.93|||||||Chi-squared|Chi-squared value= .44||Prevent lung flare-ups||||.93
73916398|NCT02970422|147362027|OTHER|||||||0.6|||||||Chi-squared|Chi-squared value= 1.87||Discuss COPD and its progression||||.60
74027483|NCT00995371|147608053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.65|||>|0.05||95.0|-4.12|15.41|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||15.41|-4.12|>0.05
73916399|NCT02970422|147362027|OTHER|||||||0.31|||||||Chi-squared|Chi-squared value= 3.61||Improve your physical well-being||||.31
73916400|NCT02970422|147362028|OTHER|||||||0.73|||||||Chi-squared|Chi-squared value: 1.31||To relieve breathlessness in adults living with COPD||||.73
73916401|NCT02970422|147362028|OTHER|||||||0.23|||||||Chi-squared|Chi-squared value= 4.28||To prevent the development of COPD||||.23
73916402|NCT02970422|147362028|OTHER|||||||0.14|||||||Chi-squared|Chi-squared value= 5.51||To prevent lung flare-ups in adults living with COPD||||.14
73916403|NCT02970422|147362028|OTHER|||||||0.52|||||||Chi-squared|Chi-squared value= 2.28||To increase the ability of adults living with COPD to exercise||||.52
73916404|NCT02970422|147362028|OTHER|||||||0.11|||||||Chi-squared|Chi-squared value= 5.88||To improve the maximal amount of exercise of adults living with COPD in and out of the home||||.11
73916405|NCT02970422|147362028|OTHER|||||||0.14|||||||Chi-squared|Chi-squared value= 5.57||To relieve breathlessness in adults living with COPD||||.14
73916406|NCT02970422|147362028|OTHER|||||||0.73|||||||Chi-squared|Chi-squared value= 1.29||To prevent the development of COPD||||.73
73916407|NCT02970422|147362028|OTHER|||||||0.2|||||||Chi-squared|Chi-squared value= 4.64||To prevent lung flare-ups in adults living with COPD||||.20
73916408|NCT02970422|147362028|OTHER|||||||0.17|||||||Chi-squared|Chi-squared value= 5.02||To increase the ability of adults living with COPD to exercise||||.17
73916409|NCT02970422|147362028|OTHER|||||||0.02|||||||Chi-squared|Chi-square value= 9.97||To improve the maximal amount of exercise of adults living with COPD in and out of the home||||.02
73916410|NCT02970422|147362029|OTHER|||||||0.05|||||||Chi-squared|Chi squared value= 17.20||Activity 1: Walking from one place to another outside of your home on a flat surface||||.05
73916411|NCT02970422|147362029|OTHER|||||||0.87|||||||Chi-squared|Chi-squared value= 4.56||Activity 2: Moving from one place to another using motorized transportation||||.87
73916412|NCT02970422|147362029|OTHER|||||||0.65|||||||Chi-squared|Chi-squared value= 6.85||Activity 3: Climbing two or more flights of stairs||||.65
73916413|NCT02970422|147362029|OTHER|||||||0.35|||||||Chi-squared|Chi-squared value= 10.00||Activity 4: Walking up a hill||||.35
73916414|NCT02970422|147362029|OTHER|||||||0.03|||||||Chi-squared|Chi-squared value= 18.75||Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness||||.03
73916415|NCT02970422|147362029|OTHER|||||||0|||||||Chi-squared|Chi-squared value= 35.52||Activity 1: Walking from one place to another outside of your home on a flat surface||||.00
73916416|NCT02970422|147362029|OTHER|||||||0.33|||||||Chi-squared|Chi-squared value= 10.23||Activity 2: Moving from one place to another using motorized transportation||||.33
73916417|NCT02970422|147362029|OTHER|||||||0|||||||Chi-squared|Chi-squared value= 23.94||Activity 3: Climbing two or more flights of stairs||||.00
73916418|NCT02970422|147362029|OTHER|||||||0.01|||||||Chi-squared|Chi-squared value= 22.80||Activity 4: Walking up a hill||||.01
73916419|NCT02970422|147362029|OTHER|||||||0.02|||||||Chi-squared|Chi-squared value= 20.43||Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness||||.02
73916420|NCT02970422|147362030|OTHER|||||||0|||||||Kruskal-Wallis|Non-parametric led to equal variance (levene's test) which couldn't be assumed, independent samples were taken (Kruskal-Wallis)|||F(3,144)=137.82|||.00
73916421|NCT02970422|147362031|OTHER|||||||0|||||||ANOVA|Factorial ANOVA used because variance could be assumed|||F(3,144)=55.89 Partial ETA squared (effect size)=0.54|||.000
73916422|NCT02970422|147362032|OTHER|||||||0|||||||ANOVA|One-way ANOVA|||F(3,142)=7.61|||.00
73916423|NCT02970422|147362033|OTHER|||||||0.31|||||||ANOVA|One-way ANOVA|||F(3,142)=1.21|||.31
73916424|NCT02970422|147362034|OTHER|||||||0.04|||||||Kruskal-Wallis|Non-parametric independent sample Kruskal-Wallis test (failed variance assumed|||F(3,139)=8.09|||.04
73916425|NCT02970422|147362035|OTHER|||||||0|||||||ANOVA|One-way ANOVA|||F(3,143)=8.01|||.00
73916426|NCT01411774|147362142|SUPERIORITY|||||||0.95||||||p \< .05 was the threshold of significance.|Mixed Models Analysis|Analysis for the outcomes used linear mixed-effects models, with treatment group as the between-participant factor and time as the within group factor||||||.95
73916427|NCT00279591|147362145|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Fisher Exact|||||||0.03
73916428|NCT02990910|147362153|SUPERIORITY||||||<|0.05|||||||Chi-squared|||Chi square test was used to compare the count data,p \< 0.05 was considered statistically significant.||||<0.05
73916429|NCT00583778|147362156|SUPERIORITY||Median Difference (Final Values)|12.0|STANDARD_DEVIATION|25.0|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using STATA 10 SE.Categorical variables were described using frequencies and relative frequencies. Distribution of continuous variables were evaluated for normality using the Shapiro-Walk test and graphically using histograms and box plots. Because most data were non-parametric, they were described using the median and 25th and 75th percentiles (interquartile range) and then compared using Wilcoxon rank sum test.|This study was designed to detect an absolute difference of 12 % in change of FEV-1percent predicted, with a standard deviation of 25% based on data provided to us from previous studies conducted by Sepracor. Based on this assumption, we sought to enter 76 patients in each group to have an 80% power to detect a 12 % absolute difference in charge of FEV-1 percent predicted over time at an alpha of 0.05. This accounted for a potential 10% dropout rate after randomization.|||< 0.05
73966381|NCT04154384|147469059|SUPERIORITY|A comparison of the proportion of participants in each arm reporting an improvement in average pain score on the Numeric Rating Scale from baseline to 3 months follow-up.||||||0.035||||||A comparison of the proportion of participants in each arm reporting an improvement in average pain score on the Numeric Rating Scale from baseline to 12 weeks follow-up.|Chi-squared|||||||0.035
73966382|NCT05048186|147469071|OTHER||Mean Difference (Final Values)|0.06||||0.503|TWO_SIDED|95.0|-0.116|0.236|||t-test, 2 sided|||we tested to see whether SDM Process scores were different between patients who received the Decision Aid Arm vs the control arm||0.236|-0.116|0.503
73966383|NCT04218266|147469094|OTHER||Crude incidence ratio|0.42|||||TWO_SIDED|90.0|0.26|0.67||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in all bleeding||0.67|0.26|
73966384|NCT04218266|147469096|OTHER||Crude incidence ratio|0.33|||||TWO_SIDED|90.0|0.09|0.97||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH CRNM bleeding||0.97|0.09|
73916430|NCT00309387|147362159|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.82||||0.03|TWO_SIDED|95.0|0.68|0.98|||Regression, Cox|||||0.98|0.68|0.03
73916431|NCT02483520|147362166|SUPERIORITY||LSM Estimate|0.03||||0.977|TWO_SIDED|95.0|-2.02|2.08|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||2.08|-2.02|.977
73916432|NCT02483520|147362167|SUPERIORITY||LSM Estimate|-0.22||||0.812|TWO_SIDED|95.0|-2.09|1.64|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.64|-2.09|.812
73966385|NCT04218266|147469097|OTHER||Crude incidence ratio|0.47|||||TWO_SIDED|90.0|0.28|0.83||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH minor bleeding||0.83|0.28|
73966386|NCT04218266|147469098|OTHER||Crude incidence ratio|0.33|||||TWO_SIDED|90.0|0.09|0.97|||Other|||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH major bleeding or CRNM bleeding||0.97|0.09|
73966387|NCT02891915|147469109|SUPERIORITY|DOOR is a composite endpoint created using clinical outcomes from the first 5 days and at Outcome Assessment Visit #1 (OAV #1). It is based on adequate clinical response at OAV #1, solicited symptoms from first 5 days and number of days of antibiotics use for worsening pneumonia from the first 5 days of the study.|Pr (Higher DOOR in Short-Course)|0.69|||<|0.001|TWO_SIDED|95.0|0.63|0.75||Missing DOOR values at OAV #1 were first imputed using linear regression using baseline covariates and available DOOR components as covariates.|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value||Null: the sum of the probability that a subject assigned to the 5-day arm will have a higher DOOR (higher DOOR is a lower value and is superior) than if assigned to the 10-day arm plus one-half the probability of equal DOORs is 50% (i.e., no difference in DOOR).||0.75|0.63|<0.001
73971333|NCT03687086|147483174|SUPERIORITY||Mean Difference (Net)|1.38|STANDARD_ERROR_OF_MEAN|0.97||0.155|TWO_SIDED|95.0|-0.52|3.29|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 Weeks vs. baseline)||||3.29|-0.52|0.155
73971334|NCT03687086|147483175|SUPERIORITY||Median Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|1.04||0.88|TWO_SIDED|95.0|-1.88|2.2|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||2.20|-1.88|0.880
73971335|NCT03687086|147483176|SUPERIORITY||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.39||0.228|TWO_SIDED|95.0|-1.25|0.3|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 weeks vs. baseline)||||0.30|-1.25|0.228
73916433|NCT02483520|147362170|SUPERIORITY||LSM Estimate|-1.5||||0.343|TWO_SIDED|95.0|-4.64|1.64|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.64|-4.64|.343
73916434|NCT02483520|147362171|SUPERIORITY||LSM Estimate|-4.79||||0.012|TWO_SIDED|95.0|-8.51|-1.08|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||-1.08|-8.51|.012
73916435|NCT02483520|147362172|SUPERIORITY||LSM Estimate|0.77||||0.033|TWO_SIDED|95.0|0.07|1.47|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.47|0.07|.033
73916436|NCT02483520|147362175|SUPERIORITY|||||||0.211|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.211
73916437|NCT02483520|147362175|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||<.001
73966388|NCT02891915|147469110|SUPERIORITY|Testing whether Short course is superior to Standard course based on DOOR at OAV #2|Pr (Higher DOOR in Short-Course)|0.63|||<|0.001|TWO_SIDED|95.0|0.57|0.69||Missing DOOR values at OAV #2 were first imputed using linear regression using baseline covariates and available DOOR components as covariates|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value.||Null: the sum of the probability that a subject assigned to the 5-day arm will have a higher DOOR (higher DOOR is a lower numerical value and is superior) than if assigned to the 10-day arm plus one-half the probability of equal DOORs is 50% (i.e., no difference in DOOR).||0.69|0.57|<0.001
73966389|NCT01091168|147469121|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.673|TWO_SIDED|95.0|0.86|1.25|||Cochran-Mantel-Haenszel|||Kaplan-Meier curves and life tables by treatment arm were provided. Confidence intervals on the median were calculated using the Brookmeyer and Crowley method. Hazard ratio and 95% confidence intervals were reported. A stratified Cox proportional model was performed to compare the two treatment arms taking into account the stratification factors (except centre) used at the time of randomisation.||1.25|0.86|0.673
73966390|NCT01091168|147469122|SUPERIORITY|||||||0.0424|||||||Log Rank|||The disease control rate (DCR) were compared in the ITT population and in the population evaluable for response between the 2 arms with a cochran Mantel Haenszel, stratified on WHO performance status at baseline, number of prior chemotherapy lines for the treatment of disease and disease measurability at Baseline.||||0.0424
73966391|NCT01091168|147469123|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4927|TWO_SIDED|95.0|0.8|1.12|||Log Rank|||PFS was compared between the 2 treatment arms by the log-rank test procedure with the 5 % significant level, stratified on the stratification factors (except study site) as specified at the time of randomisation. Os was analysed using Kaplan-Meir method and summarized with median and 95% CI of the median||1.12|0.8|0.4927
73966392|NCT04567615|147469155|SUPERIORITY||Strata adjusted difference in ORR|-2.7|||||TWO_SIDED|95.0|-10.7|5.3|||||Difference in ORR of Treatment B over ORR Treatment A|||5.3|-10.7|
74027484|NCT00995371|147608054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.05||95.0|0.61|3.77|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||3.77|0.61|<0.05
74027485|NCT00995371|147608054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||>|0.05||95.0|-0.66|2.66|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||2.66|-0.66|>0.05
73916438|NCT02483520|147362176|SUPERIORITY|||||||0.476|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.476
73916439|NCT02483520|147362176|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||.005
73966393|NCT04567615|147469158|SUPERIORITY||Cox proportional hazard model|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||HR of Treatment B over HR Treatment A|||1.33|0.75|
73966394|NCT04567615|147469159|SUPERIORITY||Strata adjusted difference in ORR|-0.9|||||TWO_SIDED|95.0|-9.2|7.4|||||Difference in ORR of Treatment B over ORR Treatment A|||7.4|-9.2|
73966395|NCT04567615|147469162|SUPERIORITY||Cox proportional hazard model|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||HR of Treatment B over HR of Treatment A|||1.33|0.75|
73966396|NCT04567615|147469163|SUPERIORITY||Cox proportional hazard model|1.05|||||TWO_SIDED|95.0|0.74|1.49|||||HR of Treatment B over HR of Treatment A|||1.49|0.74|
73966397|NCT05215847|147469205|OTHER|Adverse event subject incidence and event frequency.|||||||||||||||||Adverse event subject incidence and event frequency.|||
73966398|NCT04970407|147469243|SUPERIORITY||Treatment difference|-1.16||||0.8769|TWO_SIDED|95.0|-16.25|13.93|||MMRM model|||The adjusted mean, standard error (SE) and 95% confidence interval (CI) of the adjusted mean as well as difference in % relative to baseline and p-value were obtained from a MMRM with Fisher scoring with treatment, time (corresponding to all study visits when CMAP was measured), treatment by time interaction and baseline CMAP amplitude as factors and an unstructured variance covariance matrix.||13.93|-16.25|0.8769
74027486|NCT00995371|147608055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.13|||<|0.05||95.0|7.43|24.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||24.83|7.43|<0.05
74086088|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.224|STANDARD_ERROR_OF_MEAN|0.64||0.7276||95.0|-1.498|1.05|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.050|-1.498|0.7276
74086089|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.598||0.353||95.0|-1.748|0.631|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.631|-1.748|0.3530
74086090|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.186|STANDARD_ERROR_OF_MEAN|0.529||0.0283||95.0|0.13|2.242|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||2.242|0.130|0.0283
74027487|NCT00995371|147608055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.17|||>|0.05||95.0|-1.24|13.58|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||13.58|-1.24|>0.05
74027488|NCT01524289|147608103|SUPERIORITY||Difference in Least Squares (LS) Means|-39.7|||<|0.001|TWO_SIDED|95.0|-45.7|-33.7|||Constrained Longitudinal Data Analysis|Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model.||||-33.7|-45.7|<0.001
74086091|NCT00442546|147725980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.573||0.6934||95.0|-0.918|1.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.372|-0.918|0.6934
74086092|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.553|STANDARD_ERROR_OF_MEAN|0.77||0.0476||95.0|-3.089|-0.017|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.017|-3.089|0.0476
74027489|NCT01524289|147608104|OTHER|Pre-specified|Difference in Percentages|-2.1|||||TWO_SIDED|95.0|-11.5|8.4|||||||Miettinen and Nurminen|8.4|-11.5|
74027490|NCT01524289|147608105|OTHER|Pre-specified|Difference in Percentages|4.5|||||TWO_SIDED|95.0|-4.8|12.6|||||||Miettinen and Nurminen|12.6|-4.8|
74027491|NCT01524289|147608106|OTHER|Pre-specified|Difference in Percentages|-0.9|||||TWO_SIDED|95.0|-8.9|5.6|||||||Miettinen \& Nurminen|5.6|-8.9|
74027492|NCT01524289|147608107|OTHER|Pre-specified|Difference in Percentages|1.0|||||TWO_SIDED|95.0|-5.5|6.1|||||||Miettinen and Nurminen|6.1|-5.5|
74027493|NCT01524289|147608108|OTHER|Pre-Specified|Difference in Percentages|-8.4||||0.168|TWO_SIDED|95.0|-20.1|3.5|||Miettinen and Nurminen|||||3.5|-20.1|0.168
73860305|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3855||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS||||0.3855
73860306|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.201||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS||||0.2010
73860307|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS||||0.7104
73860308|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6107||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS||||0.6107
73860309|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6705||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.6705
73860310|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2083||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2083
73860311|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3234||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS||||0.3234
73860312|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5938||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS||||0.5938
73860313|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9711||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS||||0.9711
73860314|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS||||0.4869
73860315|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7439||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.7439
74027494|NCT01524289|147608109|OTHER|Pre-specified|Difference in Percentages|-7.4||||0.179|TWO_SIDED|95.0|-18.7|3.3|||Miettinen and Nurminen|||||3.3|-18.7|0.179
74027495|NCT01524289|147608110|OTHER|Pre-specified|Difference in Percentages|-13.9||||0.011|TWO_SIDED|95.0|-25.0|-3.1|||Miettinen and Nurminen|||||-3.1|-25.0|0.011
74027496|NCT01524289|147608111|OTHER|Pre-specified|Difference in Percentages|1.5||||0.696|TWO_SIDED|95.0|-6.8|8.4|||Miettinen and Nurminen|||||8.4|-6.8|0.696
74027497|NCT01524289|147608112|OTHER|Pre-specified|Difference in Percentages|0.5||||0.48|TWO_SIDED|95.0|-3.2|2.8|||Miettinen and Nurminen|||||2.8|-3.2|0.480
74027498|NCT01524289|147608113|OTHER|Pre-specified|Difference in Percentages|0.5||||0.722|TWO_SIDED|95.0|-4.0|3.5|||Miettinen and Nurminen|||||3.5|-4.0|0.722
74027499|NCT01524289|147608114|OTHER|Pre-specified|Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|1.9|||Miettinen and Nurminen|||||1.9|-3.7|>0.999
74086093|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.768|STANDARD_ERROR_OF_MEAN|0.764||0.0237||95.0|-3.293|-0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.243|-3.293|0.0237
74086094|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.402||0.4925||95.0|-0.516|1.069|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||1.069|-0.516|0.4925
74086095|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.414||0.8299||95.0|-0.727|0.905|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.905|-0.727|0.8299
74086096|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.37||0.9185||95.0|-0.766|0.691|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.691|-0.766|0.9185
74086097|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.339|STANDARD_ERROR_OF_MEAN|0.371||0.3619||95.0|-1.07|0.392|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.392|-1.070|0.3619
74086098|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.358|STANDARD_ERROR_OF_MEAN|0.453||0.4309||95.0|-0.538|1.254|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||1.254|-0.538|0.4309
74086099|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.459||0.9778||95.0|-0.895|0.921|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.921|-0.895|0.9778
74086100|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.777||0.8503||95.0|-1.411|1.706|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.706|-1.411|0.8503
74086101|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.845|STANDARD_ERROR_OF_MEAN|0.757||0.0183||95.0|-3.364|-0.326|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.326|-3.364|0.0183
74086102|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.141|STANDARD_ERROR_OF_MEAN|0.956||0.286||95.0|-3.598|1.316|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||1.316|-3.598|0.2860
74086103|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|1.856||0.204||95.0|-7.479|2.06|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||2.060|-7.479|0.2040
74086104|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.295||0.6332||95.0|-0.722|0.44|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.440|-0.722|0.6332
74086105|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.303||0.5183||95.0|-0.402|0.794|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.794|-0.402|0.5183
74086106|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.306||0.6341||95.0|-0.75|0.458|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.458|-0.750|0.6341
74086107|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.236|STANDARD_ERROR_OF_MEAN|0.32||0.4607||95.0|-0.868|0.395|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.395|-0.868|0.4607
74086108|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.327||0.7499||95.0|-0.541|0.75|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.750|-0.541|0.7499
73860316|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8045||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.8045
73860317|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5925||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS||||0.5925
73860318|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.683||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS||||0.6830
73860319|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8266||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS||||0.8266
73860320|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1929||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS||||0.1929
73860321|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7071||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.7071
74086109|NCT00442546|147725981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.333||0.8231||95.0|-0.584|0.733|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.733|-0.584|0.8231
74086110|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.036|STANDARD_ERROR_OF_MEAN|0.709||0.1486||95.0|-2.452|0.379|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.379|-2.452|0.1486
74086111|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.903|STANDARD_ERROR_OF_MEAN|0.706||0.0089||95.0|-3.311|-0.494|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.494|-3.311|0.0089
74086112|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.344||0.8995||95.0|-0.635|0.722|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.722|-0.635|0.8995
74086113|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.303|STANDARD_ERROR_OF_MEAN|0.354||0.3918||95.0|-1.0|0.394|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.394|-1.000|0.3918
74086114|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.33||0.9942||95.0|-0.648|0.652|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.652|-0.648|0.9942
74086115|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.206|STANDARD_ERROR_OF_MEAN|0.332||0.5352||95.0|-0.859|0.448|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.448|-0.859|0.5352
74086116|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.382||0.8055||95.0|-0.662|0.85|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.850|-0.662|0.8055
74086117|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.446|STANDARD_ERROR_OF_MEAN|0.391||0.256||95.0|-1.22|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.327|-1.220|0.2560
74086118|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.641||0.8744||95.0|-1.184|1.387|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.387|-1.184|0.8744
74086119|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.614|STANDARD_ERROR_OF_MEAN|0.616||0.0115||95.0|-2.851|-0.378|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.378|-2.851|0.0115
74027500|NCT01524289|147608115|OTHER|Pre-specified|Difference in Percentages|0.5||||0.722|TWO_SIDED|95.0|-4.0|3.5|||Miettinen and Nurminen|||||3.5|-4.0|0.722
74027501|NCT01524289|147608116|OTHER|Pre-specified|Difference in Percentages|-1.0||||0.157|TWO_SIDED|95.0|-5.4|0.9|||Miettinen and Nurminen|||||0.9|-5.4|0.157
74027502|NCT01524289|147608117|OTHER|Pre-specified|Difference in Percentages|-1.0||||0.157|TWO_SIDED|95.0|-5.4|0.9|||Miettinen and Nurminen|||||0.9|-5.4|0.157
74027503|NCT01524289|147608118|OTHER|Pre-specified|Difference in Percentages|1.5||||0.218|TWO_SIDED|95.0|-2.2|4.3|||Miettinen and Nurminen|||||4.3|-2.2|0.218
74027504|NCT01524289|147608119|OTHER|Pre-specified|Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-3.6|1.9|||Miettinen and Nurminen|||||1.9|-3.6|>0.999
73860322|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.9367
73860323|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6046||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS||||0.6046
73860324|NCT00468845|147266467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5119||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS||||0.5119
73860325|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6966||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.6966
73860326|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.1808
73860327|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2616||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.2616
73860328|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1014||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.1014
73860329|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4401||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4401
73860330|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5615||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.5615
73860331|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7615||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.7615
73860332|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6204||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.6204
73860333|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8766||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.8766
73860334|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1717||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.1717
73860335|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4065||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.4065
73860336|NCT00468845|147266468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0746
73860337|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2201||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.2201
73860338|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.0606
74027505|NCT01524289|147608120|SUPERIORITY||Difference in Least Squares (LS) Means|102.1|||<|0.001|TWO_SIDED|95.0|94.2|110.1|||Constrained Longitudinal Data Analysis|||||110.1|94.2|<0.001
74027506|NCT01524289|147608121|SUPERIORITY||Difference in LS Means|-36.4|||<|0.001|TWO_SIDED|95.0|-41.7|-31.1|||Constrained Longitudinal Data Analysis|||||-31.1|-41.7|<0.001
73860339|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.5303
73860340|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2227||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.2227
73860341|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8237||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.8237
73860342|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7476||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.7476
73860343|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6882||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.6882
73860344|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9689||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.9689
74027507|NCT01524289|147608122|SUPERIORITY||Difference in LS Means|-24.8|||<|0.001|TWO_SIDED|95.0|-29.5|-20.1|||Constrained Longitudinal Data Analysis|||||-20.1|-29.5|<0.001
74027508|NCT01524289|147608123|SUPERIORITY||Difference in LS Means|32.9|||<|0.001|TWO_SIDED|95.0|28.2|37.6|||Constrained Longitudinal Data Analysis|||||37.6|28.2|<0.001
74027509|NCT01524289|147608124|SUPERIORITY||Median Difference (Final Values)|-27.9|||<|0.001|TWO_SIDED|95.0|-34.7|-21.2|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of the median difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon's rank sum test.|||-21.2|-34.7|<0.001
74086120|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|1.155||0.9497||95.0|-3.047|2.893|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||2.893|-3.047|0.9497
74086121|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.347|STANDARD_ERROR_OF_MEAN|1.992||0.5288||95.0|-6.467|3.773|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||3.773|-6.467|0.5288
74086122|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.262||0.2595||95.0|-0.813|0.22|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.220|-0.813|0.2595
73860345|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.501||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.5010
74086123|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.27||0.9605||95.0|-0.546|0.519|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.519|-0.546|0.9605
73860346|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9143||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.9143
73860347|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7381||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.7381
73860348|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5336||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.5336
73860349|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6479||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.6479
73860350|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1133||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.1133
73860351|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7637||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.7637
73860352|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1056||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.1056
73860353|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8079||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.8079
73860354|NCT00468845|147266469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0917||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.0917
73860355|NCT00468845|147266470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7511||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.7511
73860356|NCT00468845|147266470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6742||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6742
73860357|NCT00468845|147266470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3808||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.3808
73860358|NCT00468845|147266470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7021||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.7021
73860359|NCT00468845|147266470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0045
73860360|NCT00468845|147266470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7916||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.7916
73860361|NCT00468845|147266470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3682||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.3682
73860362|NCT00468845|147266470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1419||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.1419
74086124|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.207|STANDARD_ERROR_OF_MEAN|0.251||0.4107||95.0|-0.702|0.288|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.288|-0.702|0.4107
74086125|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.318|STANDARD_ERROR_OF_MEAN|0.263||0.2271||95.0|-0.836|0.2|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.200|-0.836|0.2271
74086126|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.263||0.9552||95.0|-0.535|0.506|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.506|-0.535|0.9552
73860363|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3323||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.3323
73860364|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5662||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.5662
73860365|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9538||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.9538
73860366|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4592||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4592
73860367|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4793||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.4793
73860368|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8517||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.8517
73860369|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1829||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.1829
73860370|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3544||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.3544
73860371|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1718||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.1718
73860372|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5078||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.5078
73860373|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2443||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.2443
73916440|NCT02483520|147362177|SUPERIORITY|||||||0.677|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.677
73916441|NCT02483520|147362177|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||.020
73916442|NCT02483520|147362178|SUPERIORITY||LSM Estimate|-0.62||||0.432|TWO_SIDED|95.0|-2.18|0.94|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||0.94|-2.18|.432
73916443|NCT02483520|147362179|SUPERIORITY|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||||||.255
73916444|NCT04492618|147362201|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73916445|NCT01603056|147362202|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||t-test, 2 sided|||||||0.743
73916446|NCT01603056|147362203|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED||||||t-test, 2 sided|||||||0.627
73916447|NCT01603056|147362204|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||||||0.74
73916448|NCT01603056|147362205|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED||||||t-test, 2 sided|||||||0.641
73916449|NCT01603056|147362206|SUPERIORITY_OR_OTHER|||||||0.818|TWO_SIDED||||||t-test, 2 sided|||||||0.818
73916450|NCT01603056|147362207|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||t-test, 2 sided|||||||0.391
73916451|NCT01603056|147362208|SUPERIORITY_OR_OTHER|||||||0.497|TWO_SIDED||||||t-test, 2 sided|||||||0.497
73966399|NCT04970407|147469243|SUPERIORITY||Treatment difference|-10.61||||0.162|TWO_SIDED|95.0|-25.69|4.47|||MMRM model|||The adjusted mean, SE and 95% CI of the adjusted mean as well as difference in % relative to baseline and p-value were obtained from a MMRM with Fisher scoring with treatment, time (corresponding to all study visits when CMAP was measured), treatment by time interaction and baseline CMAP amplitude as factors and an unstructured variance covariance matrix.||4.47|-25.69|0.1620
74086127|NCT00442546|147725982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.268||0.9899||95.0|-0.533|0.526|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.526|-0.533|0.9899
73916452|NCT01603056|147362209|SUPERIORITY_OR_OTHER|||||||0.222|TWO_SIDED||||||t-test, 2 sided|||||||0.222
73916453|NCT01603056|147362210|SUPERIORITY_OR_OTHER|||||||0.438|TWO_SIDED||||||Fisher Exact|||||||0.438
73916454|NCT01603056|147362211|SUPERIORITY_OR_OTHER|||||||0.465|TWO_SIDED||||||t-test, 2 sided|||||||0.465
73916455|NCT01603056|147362212|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||t-test, 2 sided|||||||0.123
73916456|NCT01603056|147362213|SUPERIORITY_OR_OTHER|||||||0.719|TWO_SIDED||||||t-test, 2 sided|||||||0.719
73916457|NCT03250845|147362239|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||H0: No difference between Multigam 5% and Multigam 10% infusion time Ha: Multigam 10% infusion time is significantly shorter than Multigam 5%||||<0.0001
73916458|NCT03250845|147362240|SUPERIORITY||||||<|0.0005|||||||t-test, 1 sided|||H0: No difference in hospitalisation time between Multigam 5% and Multigam 10% infusion Ha: Hospitalisation time with Multigam 10% infusion is significantly shorter than with Multigam 5%||||<0.0005
73916459|NCT03250845|147362242|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||H0: No difference in number of nursing actions per patient between Multigam 5% and Multigam 10% infusion Ha: Number of nursing actions per patient is smaller with Multigam 10% infusion||||0.03
73916460|NCT02454296|147362363|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73916461|NCT02454296|147362364|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73916462|NCT02454296|147362365|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
73916463|NCT03366337|147362451|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|9.31|STANDARD_ERROR_OF_MEAN|1.3743|<|0.0001|TWO_SIDED|95.0|6.5|12.13|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||12.13|6.5|<0.0001
73916464|NCT03366337|147362451|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|8.0|STANDARD_ERROR_OF_MEAN|1.57|<|0.0001|TWO_SIDED|95.0|4.75|11.25|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||11.25|4.75|<0.0001
73916465|NCT03366337|147362451|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|5.46|STANDARD_ERROR_OF_MEAN|2.2792||0.0247|TWO_SIDED|95.0|0.76|10.16|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||10.16|0.76|0.0247
73916466|NCT03366337|147362451|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|7.83|STANDARD_ERROR_OF_MEAN|2.216||0.003|TWO_SIDED|95.0|3.11|12.55|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||12.55|3.11|0.0030
73916467|NCT01370356|147362501|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.0001|TWO_SIDED|95.0|6.09|12.53||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Assuming true CA rate of 6.9% for placebo and 17.2% for varenicline (odds ratio ≥ 2.8), a study randomizing 1404 participants (1:1 ratio) has ≥90% power to detect a difference between the two groups. Analysis was done using a logistic regression model; treatment effect as explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model including treatment-by-center interaction.||12.53|6.09|<0.0001
73966400|NCT04761302|147469267|SUPERIORITY|||||||0.215||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.215
73966401|NCT04761302|147469267|SUPERIORITY|||||||0.445||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.445
73966402|NCT04761302|147469268|SUPERIORITY|||||||0.041||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.041
73966403|NCT04761302|147469268|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.300
73966404|NCT04761302|147469269|SUPERIORITY|||||||0.12||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.12
73860374|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8296||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.8296
73966405|NCT04761302|147469269|SUPERIORITY|||||||0.359||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.359
73966406|NCT04761302|147469270|SUPERIORITY|||||||0.083||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.083
73966407|NCT04761302|147469270|SUPERIORITY|||||||0.152||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.152
73966408|NCT04761302|147469271|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.002
73860375|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3243||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.3243
73860376|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3755||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.3755
73860377|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9584||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.9584
73860378|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1187||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.1187
73860379|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7915||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.7915
73860380|NCT00468845|147266471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0703||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.0703
73860381|NCT00468845|147266472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1975||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;||||0.1975
73860382|NCT00468845|147266472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2784||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;||||0.2784
73860383|NCT00468845|147266472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0271||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0271
73860384|NCT00468845|147266472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0881||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0881
73860385|NCT00468845|147266472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0159||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0159
73860386|NCT00468845|147266472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.187||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.1870
73860387|NCT00468845|147266472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.1752
73860388|NCT00468845|147266472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6923||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.6923
73860389|NCT00468845|147266475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6295||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6295
73860390|NCT00468845|147266475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.689||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6890
73860391|NCT00468845|147266475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5094||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.5094
73860392|NCT00468845|147266475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8741||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.8741
73860393|NCT00468845|147266475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0214
73966409|NCT04761302|147469271|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
73966410|NCT04761302|147469272|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.002
73966411|NCT04761302|147469272|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
73966412|NCT04761302|147469273|SUPERIORITY|||||||0.004||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.004
73966413|NCT04761302|147469273|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
73966414|NCT04761302|147469274|SUPERIORITY|||||||0.006||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.006
73966415|NCT04761302|147469274|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
73966416|NCT04761302|147469275|SUPERIORITY|||||||0.354||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.354
73966417|NCT04761302|147469275|SUPERIORITY|||||||0.455||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.455
73966418|NCT02728557|147469276|OTHER|MLM models||||||0.016|||||||MLM|MLM||A model with two three-way interactions of time by treatment condition by attachment orientation (Time Å\~ Treatment condition Å\~ Attachment anxiety, Time Å\~ Treatment condition Å\~ Attachment avoidance) along the lower-level effects to predict differences in the slope of change in outcome. The threshold for statistical significance was p\>0.05.||||.016
73971336|NCT03687086|147483177|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.44||0.843|TWO_SIDED|95.0|-0.96|0.78|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||0.78|-0.96|0.843
73971337|NCT03687086|147483178|SUPERIORITY||Odds Ratio (OR)|3.68|STANDARD_ERROR_OF_MEAN|1.48||0.001|TWO_SIDED|95.0|1.67|8.12|||Regression, Logistic|||||8.12|1.67|0.001
73916468|NCT01370356|147362502|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.0001|TWO_SIDED|95.0|4.21|7.61||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||7.61|4.21|<0.0001
73916469|NCT01370356|147362503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.02|||<|0.0001|TWO_SIDED|95.0|2.94|5.5||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||5.50|2.94|<0.0001
73916470|NCT01370356|147362504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.69|||<|0.0001|TWO_SIDED|95.0|6.03|12.51||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 12. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||12.51|6.03|<0.0001
73916471|NCT01370356|147362504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|3.51|5.98||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 24. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||5.98|3.51|<0.0001
73916472|NCT01370356|147362504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.66|||<|0.0001|TWO_SIDED|95.0|2.05|3.44||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 52. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||3.44|2.05|<0.0001
73916473|NCT01370356|147362505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|2.05|3.47||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||3.47|2.05|<0.0001
73916474|NCT00729651|147362506|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.0|0.08|||Cochran-Mantel-Haenszel|Primary efficacy endpoint was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.|||0.08|0.00|<0.0001
73916475|NCT00729651|147362507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0091||95.0|||||ANCOVA|Least squares mean is mean of serum PTH percentage changes adjusted serum PTH level at baseline.||||||0.0091
73971338|NCT03687086|147483179|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.42||0.443|TWO_SIDED|95.0|-1.14|0.5|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 weeks vs. baseline)||||0.50|-1.14|0.443
74086128|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.578|STANDARD_ERROR_OF_MEAN|0.471||0.2211||95.0|-0.35|1.506|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||1.506|-0.350|0.2211
73916476|NCT00729651|147362508|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.01|0.04|||Cochran-Mantel-Haenszel|It was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.|||0.04|0.01|<0.0001
73916477|NCT01218243|147362510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.51|STANDARD_ERROR_OF_MEAN|0.93|<|0.01|TWO_SIDED|95.0|2.67|6.36|||ANCOVA|||||6.36|2.67|< 0.01
73916478|NCT01218243|147362511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.34|STANDARD_ERROR_OF_MEAN|6.6|>|0.05|TWO_SIDED|95.0|-9.76|16.44|||Wilcoxon (Mann-Whitney)|||||16.44|-9.76|>0.05
73971339|NCT03687086|147483180|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.51||0.409|TWO_SIDED|95.0|-1.41|0.58|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||0.58|-1.41|0.409
73971340|NCT04176601|147483192|SUPERIORITY||Mean Difference (Net)|4.32|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|1.49|7.15||||||||7.15|1.49|
74086129|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.809|STANDARD_ERROR_OF_MEAN|0.477||0.0916||95.0|-1.75|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||0.132|-1.750|0.0916
73916479|NCT01218243|147362512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.184|STANDARD_ERROR_OF_MEAN|0.8|>|0.05|TWO_SIDED|95.0|-1.41|1.78|||ANCOVA|||||1.78|-1.41|> 0.05
73916480|NCT01218243|147362513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|0.93|<|0.01|TWO_SIDED|95.0|1.36|5.05|||ANCOVA|||||5.05|1.36|< 0.01
74086130|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.42||0.9312||95.0|-0.863|0.791|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours||0.791|-0.863|0.9312
74086131|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.591|STANDARD_ERROR_OF_MEAN|0.425||0.1658||95.0|-1.428|0.247|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours||0.247|-1.428|0.1658
74086132|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.483||0.9921||95.0|-0.958|0.948|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.948|-0.958|0.9921
74086133|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.715|STANDARD_ERROR_OF_MEAN|0.479||0.1367||95.0|-1.66|0.229|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.229|-1.660|0.1367
73916481|NCT01218243|147362514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.12|STANDARD_ERROR_OF_MEAN|1.03|<|0.01|TWO_SIDED|95.0|2.07|6.18|||ANCOVA|||||6.18|2.07|<0.01
73916482|NCT04774328|147362550|OTHER|Analysis of Variance (ANOVA)|Median Difference (Final Values)|-39.28|STANDARD_ERROR_OF_MEAN|54.818||0.4812|TWO_SIDED|95.0|-152.97|74.4|||ANOVA|||||74.40|-152.97|0.4812
73971341|NCT04176601|147483193|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|1.26|8.15||||||||8.15|1.26|
74086134|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.336|STANDARD_ERROR_OF_MEAN|0.364||0.3561||95.0|-1.053|0.38|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.380|-1.053|0.3561
73916483|NCT04774328|147362551|OTHER|ANOVA|Mean Difference (Final Values)|-158.08|STANDARD_ERROR_OF_MEAN|64.232||0.0222|TWO_SIDED|95.0|-291.29|-24.87|||ANOVA|||"Applies to evoked measure of after coughing."||-24.87|-291.29|0.0222
73916484|NCT04774328|147362551|OTHER|ANOVA|Mean Difference (Final Values)|-55.04|STANDARD_ERROR_OF_MEAN|43.19||0.2158|TWO_SIDED|95.0|-144.61|34.53|||ANOVA|||"Applies to evoked measure for after sitting up."||34.53|-144.61|0.2158
74086135|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.366||0.426||95.0|-1.012|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.429|-1.012|0.4260
74086136|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.41||0.7975||95.0|-0.703|0.914|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours||0.914|-0.703|0.7975
74086137|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.412||0.6947||95.0|-0.65|0.974|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours||0.974|-0.650|0.6947
73916485|NCT04774328|147362551|OTHER|ANOVA|Mean Difference (Final Values)|-78.73|STANDARD_ERROR_OF_MEAN|42.532||0.0777|TWO_SIDED|95.0|-166.93|9.48|||ANOVA|||"Applies to evoked measure of after ambulation."||9.48|-166.93|0.0777
74086138|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.182|STANDARD_ERROR_OF_MEAN|0.465||0.6954||95.0|-1.101|0.736|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours||0.736|-1.101|0.6954
74086139|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.481||0.8665||95.0|-1.032|0.87|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours||0.870|-1.032|0.8665
74086140|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.311|STANDARD_ERROR_OF_MEAN|0.386||0.4216||95.0|-0.45|1.072|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||1.072|-0.450|0.4216
74086141|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.285|STANDARD_ERROR_OF_MEAN|0.391||0.4673||95.0|-0.487|1.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||1.056|-0.487|0.4673
74086142|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.255|STANDARD_ERROR_OF_MEAN|0.44||0.5624||95.0|-0.614|1.125|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours||1.125|-0.614|0.5624
74086143|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.448||0.3705||95.0|-1.286|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours||0.482|-1.286|0.3705
74086144|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.358|STANDARD_ERROR_OF_MEAN|0.476||0.4539||95.0|-1.302|0.586|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours||0.586|-1.302|0.4539
74086145|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.086|STANDARD_ERROR_OF_MEAN|0.515||0.0373||95.0|-2.107|-0.065|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours||-0.065|-2.107|0.0373
73916486|NCT04774328|147362552|OTHER|ANOVA|Mean Difference (Final Values)|-9.375|STANDARD_ERROR_OF_MEAN|12.7245||0.469|TWO_SIDED|95.0|-35.764|17.014|||ANOVA|||Entry applies to OC 0-96 hours.||17.014|-35.764|0.4690
73916487|NCT04774328|147362552|OTHER|ANOVA|Mean Difference (Final Values)|-8.125|STANDARD_ERROR_OF_MEAN|14.5059||0.5811|TWO_SIDED|95.0|-38.208|21.958|||ANOVA|||Applies to OC 0 - Day 8.||21.958|-38.208|0.5811
73916488|NCT02846779|147362553|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.75|1.03||||||||1.03|0.75|
73916489|NCT02846779|147362553|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.77|1.06||||||||1.06|0.77|
73916490|NCT02846779|147362554|SUPERIORITY||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.34|0.05||||||||0.05|-0.34|
73916491|NCT02846779|147362554|SUPERIORITY||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.43|-0.06||||||||-0.06|-0.43|
73916492|NCT02846779|147362555|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.95|1.11||||||||1.11|0.95|
73971342|NCT04176601|147483194|SUPERIORITY||Mean Difference (Net)|3.68|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|1.59|6.14||||||||6.14|1.59|
73971343|NCT05875467|147483203|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||.042
73971344|NCT05875467|147483204|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||||||.928
73971345|NCT05875467|147483205|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||||||.022
73916493|NCT02846779|147362555|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.92|1.06||||||||1.06|0.92|
73916494|NCT02846779|147362556|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.02||||||||1.02|0.97|
73916495|NCT02846779|147362556|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.96|1.0||||||||1.00|0.96|
73916496|NCT02846779|147362557|SUPERIORITY||Risk Ratio (RR)|1.38|||||TWO_SIDED|95.0|1.24|1.53||||||||1.53|1.24|
73916497|NCT02846779|147362557|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.85|1.07||||||||1.07|0.85|
73916498|NCT02846779|147362558|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|1.06|1.41||||||||1.41|1.06|
73916499|NCT02846779|147362558|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.99|1.32||||||||1.32|0.99|
73916500|NCT00534430|147362565|EQUIVALENCE|Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.|Median Difference (Net)|0.0|||>|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.|Log Rank|No adjustments.||Log-rank test. (Mantel-Haenszel test). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing.||||>0.05
73916501|NCT00534430|147362566|EQUIVALENCE|Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.|Median Difference (Net)|0.0|||>|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.|Gray's Test|No adjustments.||Gray's estimate. (Fine and Gray). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing||||>0.05
73916502|NCT00040937|147362568|SUPERIORITY_OR_OTHER||4-yr survival (%)|64.0|||||TWO_SIDED|95.0|55.0|74.0|||Kaplan and Meier|||The study was designed to have 82% power for detecting a 50% improvement in survival from a median of 4 years, as observed in SWOG S9321.||74|55|
73916503|NCT02324569|147362589|SUPERIORITY||Least square (LS) mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.826|-0.443|||ANCOVA|||||-0.443|-0.826|<0.0001
73916504|NCT02016560|147362599|OTHER||Cox Proportional Hazard|1.581||||0.067|TWO_SIDED|95.0|0.968|2.581||A p-value of \<0.05 was the a priori threshold for statistical significance.|Cox proportional hazards|The Cox proportional hazard model was adjusted for baseline age, American National Adult Reading Test (ANART) score, and baseline CDR-SB score.||The specific hypothesis tested was that the hazard of progressing to the clinically meaningful event (defined as CDR-SB value change of at least 1 within 18 months) will be significantly greater for subjects with flortaucipir scans rated by majority interpretation as predicted to progress (Advanced AD scan pattern), as compared to subjects with scans rated as not predicted to progress (Moderate or Not AD scan pattern).||2.581|0.968|0.067
73916505|NCT02016560|147362600|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between AD and Older Cognitively Healthy within amyloid positive group.||||<0.0001
73916506|NCT02016560|147362600|OTHER|||||||0.0622||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between MCI and Older Cognitively Healthy within the amyloid positive group.||||0.0622
73916507|NCT02016560|147362600|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between AD and MCI within the amyloid positive group.||||<0.0001
73916508|NCT02016560|147362601|EQUIVALENCE|Test of whether the least squares mean change is significantly different than zero|||||<|0.0001|||||||Mixed Models Analysis|||SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid positive subjects only.||||<0.0001
74027510|NCT02104180|147608125|NON_INFERIORITY|An estimate of the difference between the pain felt by patient during the two dressings removals along with a 95% confidence interval (CI) has been derived. If the upper limit of the confidence interval was less than 13 mm, clinical non-inferiority of Tulle Gras versus Urgotul has been demonstrated.|Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-1.339|1.864|||||The pain intensity has been analyzed using analysis of variance (ANOVA). The model for this cross-over study included sequence, period and treatment as fixed effects and subject within sequence as random effect.|||1.864|-1.339|
74027511|NCT02209597|147608143|SUPERIORITY||||||<|0.05|ONE_SIDED|90.0|||||ANOVA|||||||<0.05
74027512|NCT01855789|147608146|NON_INFERIORITY|Non-inferiority of TCZ + PBO was claimed if the upper bound of the 95% confidence interval (CI) for the mean difference was below 0.6.|Estimated Mean Difference|0.318|STANDARD_ERROR_OF_MEAN|0.139|||TWO_SIDED|95.0|0.045|0.592||||||Analysis of covariance (ANCOVA) model included Week 24 DAS28 as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>/=2.6 to \</=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>/=100 kg qw), participant anti-tumor necrosis factor (anti-TNF) exposure (Yes/No).||0.592|0.045|
73916509|NCT02016560|147362601|EQUIVALENCE|Test of whether the least squares mean change is significantly different than zero||||||0.7851|||||||Mixed Models Analysis|||SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid negative subjects only.||||0.7851
73916510|NCT02016560|147362602|OTHER||||||||||||||||||The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% confidence intervals ≥50%, for both sensitivity and specificity.|||
73916511|NCT02016560|147362603|OTHER||Pearson's correlation coefficient|-0.0925||||0.4361|TWO_SIDED||||||Pearson|||Pearson's correlation coefficient||||0.4361
73916512|NCT00911820|147362609|SUPERIORITY|||||||0.714|||||||Log Rank|||||||0.714
73916513|NCT00911820|147362611|SUPERIORITY|||||||0.605|||||||Fisher Exact|||||||0.605
73916514|NCT00911820|147362612|SUPERIORITY|||||||0.721|||||||Log Rank|||||||0.721
73916515|NCT01852110|147362613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.7623|TWO_SIDED|95.0|-1.0|1.37|||Constrained Longitudinal Data Analysis|||||1.37|-1.00|0.7623
73916516|NCT01852110|147362617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.9604|TWO_SIDED|95.0|-2.42|2.54|||Constrained Longitudinal Data Analysis|||||2.54|-2.42|0.9604
73916517|NCT01852110|147362618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.0829|TWO_SIDED|95.0|-0.01|0.22|||Constrained Longitudinal Data Analysis|||||0.22|-0.01|0.0829
73916518|NCT00410046|147362623|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Admissions to hospital||||1.0
73916519|NCT00410046|147362623|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||Therapeutic warm bath sessions||||0.23
73916520|NCT00410046|147362623|SUPERIORITY_OR_OTHER|||||||0.567|||||||Fisher Exact|||Physiotherapist visits||||0.567
73916521|NCT00410046|147362623|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||Out-patient physician visit||||0.475
73916522|NCT00410046|147362624|SUPERIORITY_OR_OTHER|||||||0.628|||||||ANCOVA|One-way ANCOVA, baseline was a covariate.||Inpatient hospitalization days per patient||||0.628
73916523|NCT00410046|147362624|SUPERIORITY_OR_OTHER|||||||0.045|||||||ANCOVA|||Therapeutic warm bath sessions per patient||||0.045
73916524|NCT00410046|147362624|SUPERIORITY_OR_OTHER|||||||0.361|||||||ANCOVA|||Physiotherapist visits per patient||||0.361
73916525|NCT00410046|147362624|SUPERIORITY_OR_OTHER|||||||0.816|||||||ANCOVA|||Out-patient physician visit per patient||||0.816
73916526|NCT00410046|147362625|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Analysis completed for patients with sick leave during the past 12 months||||1.00
73916527|NCT00410046|147362626|SUPERIORITY_OR_OTHER|||||||0.906|||||||ANCOVA|||||||0.906
73916528|NCT00410046|147362631|SUPERIORITY_OR_OTHER|||||||0.743||||||Comparison of Hospitalization 48 weeks before treatment Vs. Hospitalization during 48 treatment weeks|Fisher Exact|||||||0.743
73916529|NCT00410046|147362631|SUPERIORITY_OR_OTHER|||||||0.362||||||Comparison of Therapeutic warm bath 48 weeks before treatment Vs. Therapeutic warm bath during 48 treatment weeks|Fisher Exact|||Comparison of percentages||||0.362
73916530|NCT00410046|147362631|SUPERIORITY_OR_OTHER|||||||0.005||||||Comparison of Visit to physiotherapist 48 weeks before treatment Vs. Visit to physiotherapist during 48 treatment weeks|Fisher Exact|||||||0.005
73916531|NCT00410046|147362631|SUPERIORITY_OR_OTHER|||||||0.091||||||Comparison of Out-patient physician 48 weeks before treatment Vs. Out-patient physician during 48 treatment weeks|Fisher Exact|||||||0.091
73916532|NCT00410046|147362632|SUPERIORITY_OR_OTHER|||||||0.576||||||Comparison of Sick leave 48 weeks before treatment Vs. Sick leave during 48 weeks of treatment|Fisher Exact|||||||0.576
73916533|NCT00616200|147362690|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||Sickness Impact Profile scores improved.||||.001
73916534|NCT01104493|147362706|NON_INFERIORITY_OR_EQUIVALENCE|H0 (null): Rate difference ≥ 5 percentage points This corresponded to a null hypothesis of: HA (alternative): rate difference \< 5 percentage points.|rate difference|0.4|||||TWO_SIDED|95.0|-5.2|2.6|||score statistic|||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (Monovalent vaccine minus Placebo) evaluated against the prespecified equivalence criterion of 5 percentage points.||2.6|-5.2|
73916535|NCT00208091|147362713|SUPERIORITY_OR_OTHER||||||=|0.06||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.06
73916536|NCT00208091|147362714|SUPERIORITY_OR_OTHER||||||=|0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.23
73916537|NCT04677374|147362721|OTHER|||||||0.044|||||||Test of proportions|||||||0.044
73916538|NCT04677374|147362721|OTHER|||||||0.259|||||||Test of proportions|||||||0.259
73916539|NCT04677374|147362721|OTHER|||||||0.044|||||||Test of proportions|||||||0.044
73916540|NCT04677374|147362722|OTHER||Hazard Ratio (HR)|2.23|||||TWO_SIDED|95.0|1.01|4.93||||||||4.93|1.01|
73916541|NCT04677374|147362722|OTHER||Hazard Ratio (HR)|1.66|||||TWO_SIDED|95.0|0.69|4.0||||||||4.00|0.69|
73916542|NCT04677374|147362722|OTHER||Hazard Ratio (HR)|2.31|||||TWO_SIDED|95.0|1.0|5.36||||||||5.36|1.00|
73916543|NCT01599234|147362733|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.23||||0.22||95.0|-0.59|0.14|||ANCOVA|||The initial model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline as a covariate and treatment group, centre group, ambulatory status at baseline and previous use of cannabis as main effects. Interactions between the main effects were investigated, and if they had little influence then they were dropped from the model. These tests were performed at the 10% significance level as a possible indicator of an interactive effect.||0.14|-0.59|0.220
73916544|NCT01599234|147362734|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.341||||0.231|TWO_SIDED|95.0|0.83|2.167|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||2.167|0.830|0.231
73916545|NCT01599234|147362735|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.16||||0.857|TWO_SIDED|95.0|-1.94|1.61|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.61|-1.94|0.857
73916546|NCT01599234|147362736|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.07||||0.734|TWO_SIDED|95.0|-0.55|0.4|||ANCOVA|||The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||0.40|-0.55|0.734
73971346|NCT05875467|147483206|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
73971347|NCT01922050|147483208|SUPERIORITY||Rate ratio|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.69|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.69|0.40|<0.001
73971348|NCT01922050|147483208|SUPERIORITY||Rate ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.35|0.61|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.61|0.35|<0.001
73971349|NCT01922050|147483208|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.28|0.48|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.48|0.28|<0.001
73971350|NCT01922050|147483208|SUPERIORITY||Rate ratio|0.88||||0.38|TWO_SIDED|95.0|0.66|1.17|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||1.17|0.66|0.38
73971351|NCT01922050|147483208|SUPERIORITY||Rate ratio|0.69||||0.013|TWO_SIDED|95.0|0.52|0.93|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.93|0.52|0.013
74086146|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.476||0.76||95.0|-0.796|1.087|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||1.087|-0.796|0.7600
74086147|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.555|STANDARD_ERROR_OF_MEAN|0.481||0.2506||95.0|-1.507|0.397|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.397|-1.507|0.2506
73860394|NCT00468845|147266475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9366||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.9366
73860395|NCT00468845|147266475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7833||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.7833
73966419|NCT03897686|147469282|SUPERIORITY|\[Not specified\]|LS-means difference|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0003|TWO_SIDED|95.0|-274.96|-83.65||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||"It was determined that 144 participants randomized into 2 groups (1:1) would have at least 80% power to detect an effect size of 0.25. Sample size was calculated based on analysis of covariance adjusted for baseline value with fixed factors of group assuming α = 0.05 and 10% discontinuation rate.~The null hypothesis states that there is no difference between treatment groups in mean change from baseline to Week 25 in the total WOMAC score."||-83.65|-274.96|0.00030
73966420|NCT03897686|147469282|SUPERIORITY|\[Not specified\]|LS-means difference|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0017|TWO_SIDED|95.0|-305.11|-53.5||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~1\) Group A (NOLTREX™) OA grade II versus Group B (Placebo) ОА grade II"||-53.50|-305.11|0.0017
73966421|NCT03897686|147469282|SUPERIORITY||LS-means difference|-37.01|STANDARD_ERROR_OF_MEAN|61.85||0.9324|TWO_SIDED|95.0|-197.83|123.82||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~2\) Group A (NOLTREX™) OA grade II versus Group A (NOLTREX™) ОА grade III"||123.82|-197.83|0.9324
73966422|NCT03897686|147469282|SUPERIORITY||LS-means difference|-216.31|STANDARD_ERROR_OF_MEAN|75.01||0.0233|TWO_SIDED|95.0|-411.37|-21.25||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~3\) Group A (NOLTREX™) OA grade II versus Group B (Placebo) ОА grade III"||-21.25|-411.37|0.0233
73966423|NCT03897686|147469282|SUPERIORITY||LS-means difference|142.3|STANDARD_ERROR_OF_MEAN|81.89||0.3082|TWO_SIDED|95.0|-70.63|355.22||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~4\) Group A (NOLTREX™) OA grade III versus Group B (Placebo) ОА grade II"||355.22|-70.63|0.3082
74086148|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.027|STANDARD_ERROR_OF_MEAN|0.895||0.2567||95.0|-0.77|2.823|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours||2.823|-0.770|0.2567
74086149|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.882|STANDARD_DEVIATION|0.76||0.0167||95.0|-3.408|-0.356|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours||-0.356|-3.408|0.0167
74086150|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.352|STANDARD_ERROR_OF_MEAN|0.89||0.6953||95.0|-1.456|2.159|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours||2.159|-1.456|0.6953
73860396|NCT00468845|147266475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2983||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.2983
73966424|NCT03897686|147469282|SUPERIORITY||LS-means difference|-37.01|STANDARD_ERROR_OF_MEAN|61.85||0.9324|TWO_SIDED|95.0|-197.83|123.82||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~5\) versus Group B (Placebo) OA grade II versus Group B (Placebo) ОА grade III"||123.82|-197.83|0.9324
73966425|NCT03897686|147469282|SUPERIORITY||Slope|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0017|TWO_SIDED|95.0|-305.11|-53.5||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~6\) Group A (NOLTREX™) OA grade III versus Group B (Placebo) ОА grade III"||-53.50|-305.11|0.0017
73860397|NCT00468845|147266478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6861||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day||||0.6861
73860398|NCT00468845|147266478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day||||0.9905
73860399|NCT00468845|147266479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4264||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS||||0.4264
73860400|NCT00468845|147266479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3045||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS||||0.3045
73966426|NCT03897686|147469283|SUPERIORITY|\[Not specified\]|S-means difference|-143.39|STANDARD_ERROR_OF_MEAN|46.88||0.00267|TWO_SIDED|95.0|-236.09|-50.69||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||It was determined that 144 participants randomized into 2 groups (1:1) would have at least 80% power to detect an effect size of 0.25. Sample size was calculated based on analysis of covariance adjusted for baseline value with fixed factors of group assuming α = 0.05 and 10% discontinuation rate.||-50.69|-236.09|0.00267
73966427|NCT03897686|147469284|SUPERIORITY||LS-means difference|-13.23|STANDARD_ERROR_OF_MEAN|9.995||0.16786|TWO_SIDED|95.0|-32.096|5.638||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 3 (week 6)||5.638|-32.096|0.16786
73916547|NCT01599234|147362738|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.0||||0.624|TWO_SIDED|95.0|-2.0|1.0|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.0|-2.0|0.624
73916548|NCT01599234|147362739|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.248||||0.27|TWO_SIDED|95.0|0.842|1.849|||Regression, Logistic|||The two treatment groups were to be compared using ordinal logistic regression and the proportional odds model. The model was to incorporate ambulatory status at baseline and centre group.||1.849|0.842|0.270
73916549|NCT01599234|147362740|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.15||||0.867|TWO_SIDED|95.0|-1.95|1.64|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.64|-1.95|0.867
73916550|NCT01599234|147362741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.215||||0.569|TWO_SIDED|95.0|0.622|2.373|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||2.373|0.622|0.569
73916551|NCT02033694|147362743|OTHER||Cox Proportional Hazard|1.21||||0.0004|TWO_SIDED|95.0|1.09|1.35|||Regression, Cox|||Hypothesis 1 (Vulnerable Patient Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm is the only independent variable and NC-MACE during 2 years is the outcome. The null hypothesis tested by the Wald test that the regression coefficient in a proportional hazards regression model is significantly different from 0. This analysis determined whether maxLCBI4mmI is a risk factor for NC-MACE.||1.35|1.09|0.0004
73916552|NCT02033694|147362743|OTHER||Cox Proportional Hazard|1.45|||<|0.0001|TWO_SIDED|95.0|1.3|1.6|||Regression, Cox|||Hypothesis 2 (Vulnerable Plaque Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm in the coronary artery segment is the measure of exposure and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome. This analysis was performed with adjustment for the potential clustering effect within patient utilizing the Wei, Lin and Weissfeld (WLW) methodology. This analysis determined whether maxLCBI4mm is a risk factor NC-MACE.||1.60|1.30|<0.0001
73916553|NCT02033694|147362744|OTHER||Cox Proportional Hazard|2.18|||<|0.0001|TWO_SIDED|95.0|1.48|3.22|||Regression, Cox|||Secondary Hypothesis 1 (Vulnerable Patient)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \> 400 as the independent variable and NC-MACE during 2 years as the outcome.||3.22|1.48|<0.0001
73916554|NCT02033694|147362744|OTHER||Cox Proportional Hazard|4.22|||<|0.0001|TWO_SIDED|95.0|2.39|7.45|||Regression, Cox|||Secondary Hypothesis 2 (Vulnerable Plaque)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \> 400 in the coronary artery segment as the independent variable and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome.||7.45|2.39|<0.0001
74027513|NCT01855789|147608147|SUPERIORITY||ACR 20 Response Rate Difference|-10.2||||0.0746|TWO_SIDED|95.0|-20.2|-0.2|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-0.2|-20.2|0.0746
74027514|NCT01855789|147608147|SUPERIORITY||ACR 20 Response Rate Difference|-8.8||||0.1159|TWO_SIDED|95.0|-19.3|1.6|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||1.6|-19.3|0.1159
73916555|NCT02111772|147362774|SUPERIORITY|||||||0.049|||||||Negative binomial regression|||||||0.049
73916556|NCT02111772|147362775|SUPERIORITY||||||<|0.001|||||||Negative binomial regression|||||||<0.001
73916557|NCT01059825|147362777|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.45||||0.002|TWO_SIDED|80.0|-0.65|-0.25||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.25|-0.65|0.002
73916558|NCT01059825|147362777|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.69||||0|TWO_SIDED|80.0|-0.89|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.49|-0.89|0.000
73916559|NCT01059825|147362777|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62||||0|TWO_SIDED|80.0|-0.82|-0.42||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.42|-0.82|0.000
73916560|NCT01059825|147362777|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.72||||0|TWO_SIDED|80.0|-0.93|-0.52||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.52|-0.93|0.000
74027515|NCT01855789|147608147|SUPERIORITY||ACR 20 Response Rate Difference|-8.2|||||TWO_SIDED|95.0|-15.8|-0.6|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||-0.6|-15.8|
73916561|NCT01059825|147362777|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0|TWO_SIDED|80.0|-0.97|-0.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.56|-0.97|0.000
74086151|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.147|STANDARD_ERROR_OF_MEAN|0.894||0.208||95.0|-2.962|0.668|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours||0.668|-2.962|0.2080
74086152|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.867|STANDARD_ERROR_OF_MEAN|0.975||0.3805||95.0|-1.116|2.849|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||2.849|-1.116|0.3805
74086153|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.905||0.89||95.0|-1.965|1.713|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.713|-1.965|0.8900
74086154|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.672|STANDARD_ERROR_OF_MEAN|1.08||0.1821||95.0|-1.103|4.448|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours||4.448|-1.103|0.1821
74086155|NCT00442546|147725983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.851|STANDARD_ERROR_OF_MEAN|1.768||0.6505||95.0|-3.693|5.395|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours||5.395|-3.693|0.6505
74086156|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.029|STANDARD_ERROR_OF_MEAN|0.495||0.0388||95.0|-2.004|-0.053|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||-0.053|-2.004|0.0388
74086157|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.501||0.0004||95.0|-2.798|-0.822|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||-0.822|-2.798|0.0004
74086158|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.405||0.6274||95.0|-0.995|0.601|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.601|-0.995|0.6274
74086159|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.619|STANDARD_ERROR_OF_MEAN|0.413||0.135||95.0|-1.432|0.194|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.194|-1.432|0.1350
74086160|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.719|STANDARD_ERROR_OF_MEAN|0.448||0.1106||95.0|-1.605|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.166|-1.605|0.1106
73916562|NCT01059825|147362778|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.13||||0.049|TWO_SIDED|80.0|-0.24|-0.03||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.03|-0.24|0.049
73916563|NCT01059825|147362778|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.29||||0|TWO_SIDED|80.0|-0.39|-0.18||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.18|-0.39|0.000
74086161|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.036|STANDARD_ERROR_OF_MEAN|0.457||0.0248||95.0|-1.939|-0.133|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||-0.133|-1.939|0.0248
73916564|NCT01059825|147362778|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.22||||0.004|TWO_SIDED|80.0|-0.32|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-0.32|0.004
73916565|NCT01059825|147362778|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.17||||0.02|TWO_SIDED|80.0|-0.27|-0.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.06|-0.27|0.020
73916566|NCT01059825|147362778|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.25||||0.001|TWO_SIDED|80.0|-0.36|-0.15||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.15|-0.36|0.001
74086162|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.874|STANDARD_ERROR_OF_MEAN|0.725||0.2335||95.0|-0.582|2.33|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||2.330|-0.582|0.2335
74086163|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.568|STANDARD_ERROR_OF_MEAN|0.682||0.0258||95.0|-2.939|-0.198|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.198|-2.939|0.0258
74086164|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.866|STANDARD_ERROR_OF_MEAN|1.973||0.3878||95.0|-3.207|6.939|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||6.939|-3.207|0.3878
74086165|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.909|STANDARD_ERROR_OF_MEAN|3.754||0.1762||95.0|-3.74|15.559|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||15.559|-3.740|0.1762
74086166|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.515|STANDARD_ERROR_OF_MEAN|0.379||0.1754||95.0|-1.261|0.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.231|-1.261|0.1754
74086167|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.569|STANDARD_ERROR_OF_MEAN|0.386||0.1413||95.0|-1.329|0.191|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.191|-1.329|0.1413
74086168|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.419|STANDARD_ERROR_OF_MEAN|0.306||0.1731||95.0|-1.023|0.185|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.185|-1.023|0.1731
74086169|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.314||0.6829||95.0|-0.747|0.49|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.490|-0.747|0.6829
74086170|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.351|STANDARD_ERROR_OF_MEAN|0.3||0.2436||95.0|-0.943|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.241|-0.943|0.2436
74086171|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.313||0.119||95.0|-1.108|0.127|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.127|-1.108|0.1190
74086172|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.264|STANDARD_ERROR_OF_MEAN|0.321||0.4117||95.0|-0.897|0.369|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.369|-0.897|0.4117
73966428|NCT03897686|147469284|SUPERIORITY||LS-means difference|-26.695|STANDARD_ERROR_OF_MEAN|9.995||0.00847|TWO_SIDED|95.0|-46.46|-6.93||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 4 (week 13)||-6.93|-46.46|0.00847
73966429|NCT03897686|147469284|SUPERIORITY||LS-means difference|-33.96|STANDARD_ERROR_OF_MEAN|10.29||0.00123|TWO_SIDED|95.0|-54.31|-13.62||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 5 (week 25)||-13.62|-54.31|0.00123
73966430|NCT03897686|147469285|SUPERIORITY||LS-means difference|-0.146|STANDARD_ERROR_OF_MEAN|5.121||0.97733|TWO_SIDED|95.0|-10.271|9.98||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in stiffness WOMAC score, visit 3||9.980|-10.271|0.97733
73966431|NCT03897686|147469285|SUPERIORITY||LS-means difference|-14.5|STANDARD_ERROR_OF_MEAN|5.29||0.00693|TWO_SIDED|95.0|-24.95|-4.04||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in stiffness WOMAC score, visit 4||-4.04|-24.95|0.00693
73966432|NCT03897686|147469285|SUPERIORITY||LS-means difference|-16.18|STANDARD_ERROR_OF_MEAN|4.68||0.00073|TWO_SIDED|95.0|-25.44|-6.92||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 5 (week 25)||-6.92|-25.44|0.00073
74086173|NCT00442546|147725984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.156|STANDARD_ERROR_OF_MEAN|0.323||0.6294||95.0|-0.794|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.482|-0.794|0.6294
74086174|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.859|STANDARD_ERROR_OF_MEAN|3.315||0.7958||95.0|-7.391|5.673|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1||5.673|-7.391|0.7958
73966433|NCT03897686|147469285|SUPERIORITY||LS-means difference|-57.14|STANDARD_ERROR_OF_MEAN|32.1||0.07725|TWO_SIDED|95.0|-120.62|6.33||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 3||6.33|-120.62|0.07725
73860401|NCT00468845|147266480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0714||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS||||0.0714
73860402|NCT00468845|147266480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4455||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS||||0.4455
73860403|NCT00468845|147266481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7418||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS||||0.7418
73860404|NCT00468845|147266481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5154||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS||||0.5154
73966434|NCT03897686|147469285|SUPERIORITY||LS-means difference|-103.27|STANDARD_ERROR_OF_MEAN|33.92||0.00279|TWO_SIDED|95.0|-170.35|-36.2||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 4||-36.20|-170.35|0.00279
73971352|NCT01922050|147483208|SUPERIORITY||Rate ratio|0.79||||0.13|TWO_SIDED|95.0|0.58|1.07|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||1.07|0.58|0.13
73971353|NCT01922050|147483209|SUPERIORITY||Ratio of clearance rates|0.74||||0.57|TWO_SIDED|95.0|0.27|2.04|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.04|0.27|0.57
73971354|NCT01922050|147483209|SUPERIORITY||Ratio of clearance rates|1.33||||0.51|TWO_SIDED|95.0|0.56|3.13|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||3.13|0.56|0.51
73971355|NCT01922050|147483209|SUPERIORITY||Ratio of clearance rates|1.9||||0.11|TWO_SIDED|95.0|0.86|4.21|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||4.21|0.86|0.11
73971356|NCT01922050|147483209|SUPERIORITY||Ratio of clearance rates|1.79||||0.21|TWO_SIDED|95.0|0.72|4.43|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||4.43|0.72|0.21
73971357|NCT01922050|147483209|SUPERIORITY||Ratio of clearance rates|2.55||||0.031|TWO_SIDED|95.0|1.09|5.98|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||5.98|1.09|0.031
73971358|NCT01922050|147483209|SUPERIORITY||Ratio of clearance rates|1.43||||0.29|TWO_SIDED|95.0|0.74|2.75|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.75|0.74|0.29
73971359|NCT01922050|147483210|SUPERIORITY||Ratio of clearance rates|1.69||||0.026|TWO_SIDED|95.0|1.06|2.69|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.69|1.06|0.026
73971360|NCT01922050|147483210|SUPERIORITY||Ratio of clearance rates|1.79||||0.013|TWO_SIDED|95.0|1.13|2.84|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.84|1.13|0.013
73971361|NCT01922050|147483210|SUPERIORITY||Ratio of clearance rates|2.1|||<|0.001|TWO_SIDED|95.0|1.35|3.25|||Log binomial regression|||||3.25|1.35|<0.001
73971362|NCT01922050|147483210|SUPERIORITY||Ratio of clearance rates|1.06||||0.73|TWO_SIDED|95.0|0.76|1.47|||Log binomial regression|||||1.47|0.76|0.73
73971363|NCT01922050|147483210|SUPERIORITY||Ratio of clearance rates|1.24||||0.16|TWO_SIDED|95.0|0.92|1.67|||Log binomial regression|||||1.67|0.92|0.16
73971364|NCT01922050|147483210|SUPERIORITY||Ratio of clearance rates|1.17||||0.3|TWO_SIDED|95.0|0.87|1.57|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||1.57|0.87|0.30
73966435|NCT03897686|147469285|SUPERIORITY||LS-means difference|-133.29|STANDARD_ERROR_OF_MEAN|35.26||0.00023|TWO_SIDED|95.0|-203.03|-63.55||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 5||-63.55|-203.03|0.00023
73966436|NCT03897686|147469286|SUPERIORITY||||||<|0.005||||||The level of significance was set to p \<0.05.|Chi-squared|P-value generated by Chi-squared test was ≤0.005 for each time point.||The Chi-Square test was used to determine whether there was a statistically significant difference in disposition of results between two groups.||||<0.005
73966437|NCT03897686|147469287|SUPERIORITY||||||<|0.005||||||The level of significance was set to p \<0.05.|Chi-squared|P-value generated by Chi-squared test was ≤0.005 for each time point.||The Chi-Square test was used to determine whether there was a statistically significant difference in disposition of results between two groups.||||<0.005
74086175|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|3.322||0.9733||95.0|-6.436|6.659|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1||6.659|-6.436|0.9733
74086176|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.889|STANDARD_ERROR_OF_MEAN|3.946||0.822||95.0|-6.898|8.675|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour||8.675|-6.898|0.8220
74086177|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.813|STANDARD_ERROR_OF_MEAN|3.917||0.4736||95.0|-10.542|4.917|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour||4.917|-10.542|0.4736
74086178|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.662|STANDARD_ERROR_OF_MEAN|4.045||0.5113||95.0|-10.639|5.316|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours||5.316|-10.639|0.5113
74086179|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.365|STANDARD_ERROR_OF_MEAN|3.95||0.9266||95.0|-7.425|8.154|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours||8.154|-7.425|0.9266
74086180|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|4.347||0.9699||95.0|-8.423|8.751|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours||8.751|-8.423|0.9699
73860405|NCT00468845|147266482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6715||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS||||0.6715
73860406|NCT00468845|147266482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9013||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS||||0.9013
73860407|NCT00468845|147266483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9126||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS||||0.9126
73860408|NCT00468845|147266483|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS||||1.0000
73860409|NCT00468845|147266484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1233||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge||||0.1233
73860410|NCT00468845|147266484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1666||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge||||0.1666
73860411|NCT00468845|147266485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0361||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7||||0.0361
73860412|NCT00468845|147266485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0797||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7||||0.0797
73860413|NCT00468845|147266486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14||||0.0206
73860414|NCT00468845|147266486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14||||0.0011
73860415|NCT00468845|147266488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3506||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours||||0.3506
73860416|NCT00468845|147266489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28||||0.0287
73860417|NCT00468845|147266489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28||||0.2270
73860418|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1872||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge||||0.1872
73966438|NCT03897686|147469289|SUPERIORITY|||||||0.05||||||The threshold for statistical significance was p \<0.05.|ANCOVA|||The mean number of paracetamol tablets was calculated taking into account only patients who had received paracetamol. ANCOVA was used to detect a difference in means of 2 groups at visit 3 (week 6).||||0.050
73966439|NCT03897686|147469289|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p \<0.05.|ANCOVA|||The mean number of paracetamol tablets was calculated taking into account only patients who had received paracetamol. ANCOVA was used to detect a difference in means of 2 groups at visit 4 (week 13).||||0.004
73966440|NCT03416010|147469292|OTHER||||||<|0.001|||||||two-way ANOVA|||Null Hypothesis: There was no significant difference in Health Beliefs across those 4 time points.||||<0.001
73971365|NCT04642820|147483214|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
73971366|NCT05192109|147483238|OTHER||||||<|0.01||||||This is the p-value for the simple effect of condition.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
74086181|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|4.232||0.9482||95.0|-8.085|8.635|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours||8.635|-8.085|0.9482
73916567|NCT01059825|147362779|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0|TWO_SIDED|80.0|-0.5|-0.23||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.23|-0.50|0.000
73916568|NCT01059825|147362779|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.45||||0|TWO_SIDED|80.0|-0.59|-0.32||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.32|-0.59|0.000
73916569|NCT01059825|147362779|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.44||||0|TWO_SIDED|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.57|0.000
73916570|NCT01059825|147362779|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.36||||0|TWO_SIDED|80.0|-0.49|-0.22||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.22|-0.49|0.000
73916571|NCT01059825|147362779|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.44||||0|TWO_SIDED|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.57|0.000
74027516|NCT01855789|147608148|SUPERIORITY||ACR 50 Response Rate Difference|-13.6||||0.0377|TWO_SIDED|95.0|-24.8|-2.4|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-2.4|-24.8|0.0377
74027517|NCT01855789|147608148|SUPERIORITY||ACR 50 Response Rate Difference|-15.0||||0.013|TWO_SIDED|95.0|-26.2|-3.7|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-3.7|-26.2|0.0130
74027518|NCT01855789|147608148|SUPERIORITY||ACR 50 Response Rate Difference|-10.9|||||TWO_SIDED|95.0|-21.4|-0.4|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||-0.4|-21.4|
74027519|NCT01855789|147608149|SUPERIORITY||ACR 70 Response Rate Difference|-8.2||||0.3599|TWO_SIDED|95.0|-19.2|2.9|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||2.9|-19.2|0.3599
74027520|NCT01855789|147608149|SUPERIORITY||ACR 70 Response Rate Difference|-11.6||||0.0663|TWO_SIDED|95.0|-22.8|-0.3|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-0.3|-22.8|0.0663
73916572|NCT01059825|147362780|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.47||||0|TWO_SIDED|80.0|-0.64|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.64|0.000
73916573|NCT01059825|147362780|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.66||||0|TWO_SIDED|80.0|-0.83|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.49|-0.83|0.000
73916574|NCT01059825|147362780|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.63||||0|TWO_SIDED|80.0|-0.8|-0.45||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.45|-0.80|0.000
73916575|NCT01059825|147362780|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.65||||0|TWO_SIDED|80.0|-0.82|-0.47||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.47|-0.82|0.000
73916576|NCT01059825|147362780|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.67||||0|TWO_SIDED|80.0|-0.84|-0.5||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.50|-0.84|0.000
73916577|NCT01059825|147362782|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.15||||0.007|TWO_SIDED|80.0|-1.75|-0.55||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.55|-1.75|0.007
74027521|NCT01855789|147608149|SUPERIORITY||ACR 70 Response Rate Difference|-8.2|||||TWO_SIDED|95.0|-19.4|3.1|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||3.1|-19.4|
74086182|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.915|STANDARD_ERROR_OF_MEAN|7.391||0.7969||95.0|-16.842|13.012|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||13.012|-16.842|0.7969
74086183|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.023|STANDARD_ERROR_OF_MEAN|7.68||0.1991||95.0|-25.533|5.487|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||5.487|-25.533|0.1991
74027522|NCT01855789|147608150|SUPERIORITY||DAS28 Worsening Rate Difference|7.5||||0.2371|TWO_SIDED|95.0|-2.4|17.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||17.3|-2.4|0.2371
73916578|NCT01059825|147362782|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.75||||0|TWO_SIDED|80.0|-2.35|-1.14||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.14|-2.35|0.000
73966441|NCT03416010|147469292|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the full intervention group, COPE-P, and the attention-control group, Preg+, in Health Beliefs, as measured by the Healthy Lifestyle Beliefs measure, at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birth||||<0.001
73966442|NCT03416010|147469292|OTHER|||||||0.009|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||0.009
73966443|NCT03416010|147469293|OTHER||||||<|0.001||||||Threshold for significance: p \<0.01|two-way ANOVA|||Null hypothesis: there was no significant difference in anxiety across the 4 time points.||||<0.001
73966444|NCT03416010|147469293|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in anxiety at T0 baseline, as well as at timepoint 1(immediately following the intervention), timepoint 2 (6 weeks after the infants' birth), and timepoint 3 (6 months after the infants' birth).||||<0.001
73966445|NCT03416010|147469293|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
73966446|NCT03416010|147469294|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in health behaviors across those 4 time points.||||<0.001
73966447|NCT03416010|147469294|OTHER||||||<|0.001|||||||two-way ANOVA|||||||<0.001
73966448|NCT03416010|147469294|OTHER||||||<|0.001|||||||two-way ANOVA|||Null Hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
73966449|NCT03416010|147469295|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in depressive symptoms across those 4 timepoints.||||<0.001
74086184|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|86.335|STANDARD_ERROR_OF_MEAN|22.737||0.0321||95.0|13.976|158.693|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours||158.693|13.976|0.0321
73916579|NCT01059825|147362782|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.15||||0|TWO_SIDED|80.0|-2.76|-1.54||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.54|-2.76|0.000
73916580|NCT01059825|147362782|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.91||||0|TWO_SIDED|80.0|-2.52|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.30|-2.52|0.000
73966450|NCT03416010|147469295|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in depressive symptoms at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birth.||||<0.001
73966451|NCT03416010|147469295|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
73966452|NCT03416010|147469296|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in stress across those 4 time points.||||<0.001
73966453|NCT03416010|147469296|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in stress, as measured by the GAD-7, at T0 baseline, as well as at timepoint 1 (immediately following the intervention), timepoint 2 (6 weeks after the infants' birth) and timepoint 3 (6 months after the infants' birth).||||<0.001
73966454|NCT03416010|147469296|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
73966455|NCT04505774|147469361|SUPERIORITY|||||||0.6778|||||||t-test, 2 sided|||||||.6778
73966456|NCT04505774|147469361|SUPERIORITY|||||||0.6292|||||||t-test, 2 sided|||||||.6292
73966457|NCT04505774|147469361|SUPERIORITY|||||||0.6858|||||||t-test, 2 sided|||||||.6858
73966458|NCT04505774|147469361|SUPERIORITY|||||||0.1351|||||||t-test, 2 sided|||||||.1351
73966459|NCT04505774|147469362|SUPERIORITY|||||||0.1959|||||||Chi-squared|||||||.1959
73966460|NCT04505774|147469362|SUPERIORITY|||||||0.9496|||||||Chi-squared|||||||0.9496
73966461|NCT04505774|147469362|SUPERIORITY|||||||0.9902|||||||Chi-squared|||||||.9902
73966462|NCT04505774|147469362|SUPERIORITY|||||||0.0814|||||||Chi-squared|||||||.0814
73966463|NCT04505774|147469363|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
73966464|NCT04505774|147469363|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73966465|NCT04505774|147469363|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73966466|NCT04505774|147469364|SUPERIORITY|||||||0.0577|||||||Chi-squared|||||||.0577
73966467|NCT04505774|147469364|SUPERIORITY|||||||0.5015|||||||Chi-squared|||||||.5015
73966468|NCT04505774|147469364|SUPERIORITY|||||||0.5892|||||||Chi-squared|||||||.5892
73966469|NCT04505774|147469364|SUPERIORITY|||||||0.1714|||||||Chi-squared|||||||.1714
73966470|NCT04505774|147469365|SUPERIORITY|||||||0.0732|||||||Chi-squared|||||||.0732
73966471|NCT04505774|147469365|SUPERIORITY|||||||0.9018|||||||Chi-squared|||||||.9018
73966472|NCT04505774|147469365|SUPERIORITY|||||||0.5075|||||||Chi-squared|||||||.5075
73966473|NCT04505774|147469365|SUPERIORITY|||||||0.145|||||||Chi-squared|||||||.1450
73966474|NCT04505774|147469366|SUPERIORITY|||||||0.8837|||||||Chi-squared|||||||.8837
73966475|NCT04505774|147469366|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73966476|NCT04505774|147469366|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73916581|NCT01059825|147362782|SUPERIORITY_OR_OTHER||Difference in least squares means|0.45||||0.833|TWO_SIDED|80.0|-0.15|1.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.06|-0.15|0.833
73916582|NCT01059825|147362783|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.42||||0.043|TWO_SIDED|80.0|-0.73|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-0.73|0.043
73916583|NCT01059825|147362783|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.13||||0|TWO_SIDED|80.0|-1.44|-0.81||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.81|-1.44|0.000
73916584|NCT01059825|147362783|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0|TWO_SIDED|80.0|-1.22|-0.59||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.59|-1.22|0.000
73916585|NCT01059825|147362783|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.87||||0|TWO_SIDED|80.0|-1.18|-0.55||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.55|-1.18|0.000
73916586|NCT01059825|147362783|SUPERIORITY_OR_OTHER||Difference in least squares means|0.45||||0.967|TWO_SIDED|80.0|0.14|0.76||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.76|0.14|0.967
73916587|NCT01059825|147362784|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0.008|TWO_SIDED|80.0|-1.17|-0.36||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.36|-1.17|0.008
73916588|NCT01059825|147362784|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.32||||0|TWO_SIDED|80.0|-1.73|-0.91||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.91|-1.73|0.000
73916589|NCT01059825|147362784|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.24||||0|TWO_SIDED|80.0|-1.65|-0.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.83|-1.65|0.000
73916590|NCT01059825|147362784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-1.08||||0|TWO_SIDED|80.0|-1.49|-0.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward..||||-0.67|-1.49|0.000
73916591|NCT01059825|147362784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.922|TWO_SIDED|80.0|0.04|0.86||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.86|0.04|0.922
73916592|NCT01059825|147362785|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.03||||0.003|TWO_SIDED|80.0|-1.51|-0.56||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.56|-1.51|0.003
73916593|NCT01059825|147362785|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.57||||0|TWO_SIDED|80.0|-2.04|-1.09||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.09|-2.04|0.000
73916594|NCT01059825|147362785|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.68||||0|TWO_SIDED|80.0|-2.16|-1.21||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.21|-2.16|0.000
73916595|NCT01059825|147362785|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.78||||0|TWO_SIDED|80.0|-2.26|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.30|-2.26|0.000
73916596|NCT01059825|147362785|SUPERIORITY_OR_OTHER||Difference in least squares means|0.24||||0.741|TWO_SIDED|80.0|-0.24|0.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.71|-0.24|0.741
73916597|NCT01059825|147362787|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.13||||0.163|TWO_SIDED|80.0|-4.92|0.65||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.65|-4.92|0.163
73916598|NCT01059825|147362787|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.48||||0.056|TWO_SIDED|80.0|-6.28|-0.68||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.68|-6.28|0.056
73916599|NCT01059825|147362787|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.88||||0.096|TWO_SIDED|80.0|-5.7|-0.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.05|-5.70|0.096
73916600|NCT01059825|147362787|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.37||||0.064|TWO_SIDED|80.0|-6.21|-0.53||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.53|-6.21|0.064
73916601|NCT01059825|147362787|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.54||||0.403|TWO_SIDED|80.0|-3.33|2.26||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.26|-3.33|0.403
73966477|NCT04505774|147469366|SUPERIORITY|||||||0.5343|||||||Chi-squared|||||||.5343
73966478|NCT04505774|147469367|SUPERIORITY|||||||0.6636|||||||t-test, 2 sided|||||||.6636
73966479|NCT04505774|147469367|SUPERIORITY|||||||0.5878|||||||t-test, 2 sided|||||||.5878
73966480|NCT04505774|147469367|SUPERIORITY|||||||0.7148|||||||t-test, 2 sided|||||||.7148
73966481|NCT04505774|147469367|SUPERIORITY|||||||0.1117|||||||t-test, 2 sided|||||||.1117
73966482|NCT04505774|147469368|SUPERIORITY|||||||0.678|||||||t-test, 2 sided|||||||.6780
73966483|NCT04505774|147469368|SUPERIORITY|||||||0.6638|||||||t-test, 2 sided|||||||.6638
73916602|NCT01059825|147362788|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0.425|TWO_SIDED|80.0|-2.91|2.17||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.17|-2.91|0.425
73916603|NCT01059825|147362788|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.81||||0.082|TWO_SIDED|80.0|-5.38|-0.23||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.23|-5.38|0.082
73916604|NCT01059825|147362788|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.35||||0.43|TWO_SIDED|80.0|-2.92|2.21||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.21|-2.92|0.430
73916605|NCT01059825|147362788|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.47||||0.043|TWO_SIDED|80.0|-6.05|-0.89||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.89|-6.05|0.043
73916606|NCT01059825|147362788|SUPERIORITY_OR_OTHER||Difference in least squares means|1.01||||0.694|TWO_SIDED|80.0|-1.55|3.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||3.58|-1.55|0.694
73916607|NCT01059825|147362789|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.38||||0.234|TWO_SIDED|80.0|-3.81|1.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.05|-3.81|0.234
74086185|NCT00442546|147725985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|44.964|STANDARD_ERROR_OF_MEAN|12.295||0.0353||95.0|5.837|84.091|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours||84.091|5.837|0.0353
73916608|NCT01059825|147362789|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.59||||0.087|TWO_SIDED|80.0|-5.03|-0.14||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.14|-5.03|0.087
73916609|NCT01059825|147362789|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.86||||0.068|TWO_SIDED|80.0|-5.33|-0.4||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.40|-5.33|0.068
73916610|NCT01059825|147362789|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.77||||0.346|TWO_SIDED|80.0|-3.25|1.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.71|-3.25|0.346
73916611|NCT01059825|147362789|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0.346|TWO_SIDED|80.0|-3.21|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.70|-3.21|0.346
73916612|NCT01059825|147362790|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.1||||0.306|TWO_SIDED|80.0|-3.87|1.67||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.67|-3.87|0.306
73916613|NCT01059825|147362790|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.41||||0.133|TWO_SIDED|80.0|-5.19|0.37||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.37|-5.19|0.133
73916614|NCT01059825|147362790|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.61||||0.117|TWO_SIDED|80.0|-5.42|0.2||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.20|-5.42|0.117
73966484|NCT04505774|147469368|SUPERIORITY|||||||0.7645|||||||t-test, 2 sided|||||||.7645
73966485|NCT04505774|147469368|SUPERIORITY|||||||0.0987|||||||t-test, 2 sided|||||||0.0987
73966486|NCT04505774|147469369|SUPERIORITY|||||||0.4016|||||||t-test, 2 sided|||||||.4016
73966487|NCT04505774|147469369|SUPERIORITY|||||||0.5815|||||||t-test, 2 sided|||||||.5815
73966488|NCT04505774|147469369|SUPERIORITY|||||||0.9085|||||||t-test, 2 sided|||||||.9085
73966489|NCT04505774|147469369|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||.0820
73966490|NCT04505774|147469370|SUPERIORITY|||||||0.3135|||||||Chi-squared|||||||.3135
73966491|NCT04505774|147469370|SUPERIORITY|||||||0.9581|||||||Chi-squared|||||||.9581
73966492|NCT04505774|147469370|SUPERIORITY|||||||0.9661|||||||Chi-squared|||||||.9661
73916615|NCT01059825|147362790|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.87||||0.097|TWO_SIDED|80.0|-5.69|-0.04||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.04|-5.69|0.097
73916616|NCT01059825|147362790|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.0||||0.179|TWO_SIDED|80.0|-4.78|0.79||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.79|-4.78|0.179
73966493|NCT04505774|147469370|SUPERIORITY|||||||0.1073|||||||Chi-squared|||||||.1073
73966494|NCT04505774|147469371|SUPERIORITY|||||||0.3575|||||||Chi-squared|||||||.3575
73966495|NCT04505774|147469371|SUPERIORITY|||||||0.591|||||||Chi-squared|||||||.5910
73966496|NCT04505774|147469371|SUPERIORITY|||||||0.867|||||||Chi-squared|||||||.8670
73966497|NCT04505774|147469371|SUPERIORITY|||||||0.0645|||||||Chi-squared|||||||.0645
73966498|NCT04788537|147469372|SUPERIORITY|Linear mixed model regression|Slope|-1.58||||0.006|TWO_SIDED||||||Mixed Models Analysis||Slope reported is for Time x Group Interaction|||||.006
73966499|NCT05343390|147469380|SUPERIORITY||Mean Difference (Final Values)|20.6|||<|0.001|TWO_SIDED|95.0|16.1|25.1|||Regression, Linear|A linear model fit using generalized estimating equations to account for correlated observations within clusters.||||25.1|16.1|<0.001
73966500|NCT05343390|147469381|SUPERIORITY||Mean Difference (Final Values)|11.1|||<|0.001|TWO_SIDED|95.0|5.9|16.4|||Regression, Linear|A linear model fit using generalized estimating equations to account for correlated observations within clusters.||||16.4|5.9|<0.001
73966501|NCT05343390|147469382|SUPERIORITY||Rate Ratio|1.22||||0.14|TWO_SIDED|95.0|0.93|1.6|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.60|0.93|0.14
73966502|NCT05343390|147469383|SUPERIORITY||Rate Ratio|1.37||||0.006|TWO_SIDED|95.0|1.1|1.71|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.71|1.10|0.006
73966503|NCT05343390|147469384|SUPERIORITY||Rate Ratio|2.29||||0.013|TWO_SIDED|95.0|1.19|4.4|||Mixed Models Analysis|Negative binomial mixed-effect model||||4.40|1.19|0.013
73916617|NCT01059825|147362792|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.93||||0.072|TWO_SIDED|80.0|-3.62|-0.24||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.24|-3.62|0.072
74086186|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.812|STANDARD_ERROR_OF_MEAN|12.055||0.5736||95.0|-30.792|17.169|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||17.169|-30.792|0.5736
73860419|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3994||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge||||0.3994
73916618|NCT01059825|147362792|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.81||||0.086|TWO_SIDED|80.0|-3.51|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-3.51|0.086
73966504|NCT05343390|147469385|SUPERIORITY||Rate Ratio|1.45||||0.01|TWO_SIDED|95.0|1.1|1.92|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.92|1.10|0.01
73860420|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0422||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28||||0.0422
73860421|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3647||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28||||0.3647
73860422|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1729||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge||||0.1729
73860423|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2234||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge||||0.2234
73860424|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.095||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28||||0.0950
73860425|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4345||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28||||0.4345
73860426|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge||||0.2840
73860427|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6404||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge||||0.6404
73860428|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28||||0.0550
73860429|NCT00468845|147266490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4531||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28||||0.4531
74086187|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.991|STANDARD_ERROR_OF_MEAN|11.786||0.8003||95.0|-26.438|20.455|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||20.455|-26.438|0.8003
73860430|NCT00468845|147266491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9712||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.9712
73860431|NCT00468845|147266491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0112||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0112
73860432|NCT00468845|147266491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.0090
73860433|NCT00468845|147266491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.865||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.8650
73860434|NCT00468845|147266492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8914||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge||||0.8914
73860435|NCT00468845|147266492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge||||0.2214
73860436|NCT00468845|147266492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1008||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28||||0.1008
73860437|NCT00468845|147266492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9135||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28||||0.9135
73860438|NCT00468845|147266492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge||||0.5609
73860439|NCT00468845|147266492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4047||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge||||0.4047
73860440|NCT00468845|147266492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1663||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28||||0.1663
73860441|NCT00468845|147266492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8364||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28||||0.8364
73860442|NCT00468845|147266493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7218||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.7218
73916619|NCT01059825|147362792|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.99||||0.002|TWO_SIDED|80.0|-5.71|-2.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-2.27|-5.71|0.002
73916620|NCT01059825|147362792|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.64||||0.025|TWO_SIDED|80.0|-4.37|-0.92||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.92|-4.37|0.025
73966505|NCT05343390|147469386|SUPERIORITY||Rate Ratio|1.28||||0.12|TWO_SIDED|95.0|0.94|1.76|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.76|0.94|0.12
74086188|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.815|STANDARD_ERROR_OF_MEAN|10.371||0.5125||95.0|-27.369|13.74|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||13.740|-27.369|0.5125
74086189|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.294|STANDARD_ERROR_OF_MEAN|10.227||0.4773||95.0|-27.563|12.976|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||12.976|-27.563|0.4773
74086190|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.915|STANDARD_ERROR_OF_MEAN|11.101||0.2142||95.0|-36.055|8.226|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||8.226|-36.055|0.2142
74086191|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.769|STANDARD_ERROR_OF_MEAN|11.245||0.2989||95.0|-34.197|10.659|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||10.659|-34.197|0.2989
74086192|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.51|STANDARD_ERROR_OF_MEAN|45.612||0.3829||95.0|-53.429|134.449|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||134.449|-53.429|0.3829
74086193|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.25|STANDARD_ERROR_OF_MEAN|45.322||0.5531||95.0|-120.59|66.092|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||66.092|-120.59|0.5531
74086194|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.513|STANDARD_ERROR_OF_MEAN|8.491||0.2738||95.0|-89.376|126.402|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||126.402|-89.376|0.2738
74086195|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.644|STANDARD_ERROR_OF_MEAN|2.519||0.7987||95.0|-4.343|5.63|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||5.630|-4.343|0.7987
73916621|NCT01059825|147362792|SUPERIORITY_OR_OTHER||Difference in least squares means|0.88||||0.746|TWO_SIDED|80.0|-0.82|2.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.58|-0.82|0.746
73916622|NCT01059825|147362793|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.69||||0.289|TWO_SIDED|80.0|-2.27|0.9||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.90|-2.27|0.289
73916623|NCT01059825|147362793|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.7||||0.288|TWO_SIDED|80.0|-2.31|0.91||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.91|-2.31|0.288
73916624|NCT01059825|147362793|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.41||||0.13|TWO_SIDED|80.0|-3.01|0.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.19|-3.01|0.130
73916625|NCT01059825|147362793|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.44||||0.026|TWO_SIDED|80.0|-4.05|-0.84||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.84|-4.05|0.026
74086196|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|2.441||0.8875||95.0|-5.177|4.485|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||4.485|-5.177|0.8875
74086197|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.537|STANDARD_ERROR_OF_MEAN|1.949||0.4319||95.0|-2.324|5.398|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||5.398|-2.324|0.4319
74086198|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|1.935||0.407||95.0|-2.223|5.443|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||5.443|-2.223|0.4070
74086199|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.119|STANDARD_ERROR_OF_MEAN|1.641||0.4968||95.0|-4.371|2.133|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.133|-4.371|0.4968
74086200|NCT00442546|147725986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.327|STANDARD_ERROR_OF_MEAN|1.665||0.427||95.0|-1.972|4.626|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||4.626|-1.972|0.4270
74086201|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.862|STANDARD_ERROR_OF_MEAN|2.999||0.7742||95.0|-6.775|5.052|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||5.052|-6.775|0.7742
74086202|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.006|STANDARD_ERROR_OF_MEAN|3.025||0.0996||95.0|-0.96|10.971|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||10.971|-0.960|0.0996
74086203|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.803|STANDARD_ERROR_OF_MEAN|2.79||0.7738||95.0|-4.698|6.304|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||6.304|-4.698|0.7738
74086204|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.192|STANDARD_ERROR_OF_MEAN|2.778||0.1328||95.0|-1.284|9.669|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||9.669|-1.284|0.1328
73916626|NCT01059825|147362793|SUPERIORITY_OR_OTHER||Difference in least squares means|1.49||||0.883|TWO_SIDED|80.0|-0.11|3.08||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||3.08|-0.11|0.883
73916627|NCT01059825|147362794|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.67||||0.063|TWO_SIDED|80.0|-3.07|-0.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.27|-3.07|0.063
74086205|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.928|STANDARD_ERROR_OF_MEAN|3.012||0.7585||95.0|-5.027|6.882|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||6.882|-5.027|0.7585
74086206|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.946|STANDARD_ERROR_OF_MEAN|2.997||0.19||95.0|-1.979|9.871|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||9.871|-1.979|0.1900
74086207|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|3.693||0.2365||95.0|-3.004|11.865|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||11.865|-3.004|0.2365
73966506|NCT03655132|147469408|OTHER|Regression of baseline score on intrinsic motivation to use VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.12||||0.62|TWO_SIDED||||||Regression, Linear|||||||.62
73966507|NCT03655132|147469408|OTHER|Regression of baseline score on perceived ease of use of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.19||||0.45|TWO_SIDED||||||Regression, Linear|||||||.45
73966508|NCT03655132|147469408|OTHER|Regression of baseline score on perceived usefulness of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.02||||0.93|TWO_SIDED||||||Regression, Linear|||||||.93
73966509|NCT03655132|147469408|OTHER|Regression of post-intervention score of intrinsic motivation to use VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.51||||0.04|TWO_SIDED||||||Regression, Linear|||||||.04
73966510|NCT03655132|147469408|OTHER|Regression of post-intervention score of perceived ease of use of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.54||||0.03|TWO_SIDED||||||Regression, Linear|||||||.03
73966511|NCT03655132|147469408|OTHER|Regression of post-intervention score of perceived usefulness of VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.58||||0.01|TWO_SIDED||||||Regression, Linear|||||||.01
73966512|NCT03655132|147469409|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8) for waitlist control group participants only (n=22).|Median Difference (Net)|-5.0||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.54
73966513|NCT03655132|147469409|OTHER||Median Difference (Net)|-1.5||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8) for VACT-CP group.||||.59
73966514|NCT03655132|147469410|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|2.0||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.78
73860443|NCT00468845|147266493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4425||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.4425
73860444|NCT00468845|147266494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7889||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.7889
73860445|NCT00468845|147266494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1565||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.1565
73860446|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6211||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale||||0.6211
73860447|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3687||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale||||0.3687
73860448|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7078||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale||||0.7078
73860449|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8696||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale||||0.8696
73860450|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale||||0.4320
73860451|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8843||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale||||0.8843
73860452|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6215||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale||||0.6215
73860453|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2722||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale||||0.2722
73860454|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale||||0.5500
73860455|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9942||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale||||0.9942
73860456|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0075||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia||||0.0075
73860457|NCT00468845|147266495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1464||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia||||0.1464
73860458|NCT00468845|147266496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9877||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.||||0.9877
73860459|NCT00468845|147266496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1334||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.||||0.1334
73860460|NCT00468845|147266496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3566||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.||||0.3566
73860461|NCT00468845|147266496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6262||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.||||0.6262
73860462|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9463||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;||||0.9463
73860463|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7347||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;||||0.7347
73860464|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4132||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;||||0.4132
73916628|NCT01059825|147362794|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.29||||0.019|TWO_SIDED|80.0|-3.69|-0.88||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.88|-3.69|0.019
73916629|NCT01059825|147362794|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.01||||0.035|TWO_SIDED|80.0|-3.43|-0.59||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.59|-3.43|0.035
73916630|NCT01059825|147362794|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.3||||0.121|TWO_SIDED|80.0|-2.73|0.12||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.12|-2.73|0.121
73916631|NCT01059825|147362794|SUPERIORITY_OR_OTHER||Difference in least squares means|0.29||||0.602|TWO_SIDED|80.0|-1.13|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.70|-1.13|0.602
73916632|NCT01059825|147362795|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.2||||0.045|TWO_SIDED|80.0|-3.86|-0.54||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.54|-3.86|0.045
73916633|NCT01059825|147362795|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.49||||0.126|TWO_SIDED|80.0|-3.16|0.18||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.18|-3.16|0.126
73916634|NCT01059825|147362795|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.03||||0.011|TWO_SIDED|80.0|-4.72|-1.34||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.34|-4.72|0.011
73916635|NCT01059825|147362795|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.99||||0.066|TWO_SIDED|80.0|-3.69|-0.3||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-3.69|0.066
73916636|NCT01059825|147362795|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.48||||0.357|TWO_SIDED|80.0|-2.15|1.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.19|-2.15|0.357
73916637|NCT01059825|147362797|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.99||||0|TWO_SIDED|80.0|-28.29|-13.69||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.69|-28.29|0.000
73916638|NCT01059825|147362797|SUPERIORITY_OR_OTHER||Difference in least squares means|-25.82||||0|TWO_SIDED|80.0|-33.17|-18.47||P-value is one-sided.P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-18.47|-33.17|0.000
73916639|NCT01059825|147362797|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.23||||0|TWO_SIDED|80.0|-41.64|-26.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-26.83|-41.64|0.000
73916640|NCT01059825|147362797|SUPERIORITY_OR_OTHER||Difference in least squares means|-32.02||||0|TWO_SIDED|80.0|-39.49|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.56|-39.49|0.000
73916641|NCT01059825|147362797|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.05||||0|TWO_SIDED|80.0|-27.39|-12.72||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-12.72|-27.39|0.000
73916642|NCT01059825|147362798|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.96||||0|TWO_SIDED|80.0|-28.58|-13.34||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.34|-28.58|0.000
73916643|NCT01059825|147362798|SUPERIORITY_OR_OTHER||Difference in least squares means|-21.57||||0|TWO_SIDED|80.0|-29.27|-13.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.86|-29.27|0.000
73916644|NCT01059825|147362798|SUPERIORITY_OR_OTHER||Difference in least squares means|-32.54||||0|TWO_SIDED|80.0|-40.2|-24.88||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.88|-40.20|0.000
73916645|NCT01059825|147362798|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.33||||0|TWO_SIDED|80.0|-30.05|-14.61||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-14.61|-30.05|0.000
73916646|NCT01059825|147362798|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.57||||0|TWO_SIDED|80.0|-28.19|-12.96||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-12.96|-28.19|0.000
73916647|NCT01059825|147362799|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.09||||0|TWO_SIDED|80.0|-29.16|-15.01||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.01|-29.16|0.000
73916648|NCT01059825|147362799|SUPERIORITY_OR_OTHER||Difference in least squares means|-27.94||||0|TWO_SIDED|80.0|-35.06|-20.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-20.83|-35.06|0.000
73916649|NCT01059825|147362799|SUPERIORITY_OR_OTHER||Difference in least squares means|-33.12||||0|TWO_SIDED|80.0|-40.29|-25.95||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-25.95|-40.29|0.000
74086208|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.306|STANDARD_ERROR_OF_MEAN|3.73||0.1616||95.0|-2.202|12.814|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||12.814|-2.202|0.1616
74086209|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.071|STANDARD_ERROR_OF_MEAN|6.911||0.8819||95.0|-17.98|15.838|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||15.838|-17.98|0.8819
74086210|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.071|STANDARD_ERROR_OF_MEAN|11.7||0.4676||95.0|-37.7|19.558|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||19.558|-37.70|0.4676
74086211|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.925|STANDARD_ERROR_OF_MEAN|2.195||0.3813||95.0|-2.403|6.254|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||6.254|-2.403|0.3813
74086212|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.341|STANDARD_ERROR_OF_MEAN|2.236||0.2966||95.0|-2.07|6.751|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||6.751|-2.070|0.2966
74086213|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.962|STANDARD_ERROR_OF_MEAN|2.576||0.4474||95.0|-3.122|7.046|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||7.046|-3.122|0.4474
74086214|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.316|STANDARD_ERROR_OF_MEAN|2.59||0.0416||95.0|0.204|10.427|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.427|0.204|0.0416
74086215|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.372|STANDARD_ERROR_OF_MEAN|2.566||0.5935||95.0|-3.694|6.438|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||6.438|-3.694|0.5935
74086216|NCT00442546|147725987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.272|STANDARD_ERROR_OF_MEAN|2.674||0.3966||95.0|-3.006|7.551|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||7.551|-3.006|0.3966
74086217|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.729|STANDARD_ERROR_OF_MEAN|2.631||0.5117||95.0|-3.457|6.916|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||6.916|-3.457|0.5117
74086218|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.532|STANDARD_ERROR_OF_MEAN|2.675||0.0154||95.0|1.258|11.805|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||11.805|1.258|0.0154
74086219|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.901|STANDARD_ERROR_OF_MEAN|2.353||0.7022||95.0|-3.738|5.54|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||5.540|-3.738|0.7022
74086220|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.509|STANDARD_ERROR_OF_MEAN|2.343||0.0557||95.0|-0.11|9.129|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||9.129|-0.110|0.0557
73860465|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4929||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;||||0.4929
73860466|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6003||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;||||0.6003
73860467|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9343||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;||||0.9343
73860468|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3838||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;||||0.3838
73860469|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1351||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;||||0.1351
73860470|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3343||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;||||0.3343
73860471|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7948||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;||||0.7948
73860472|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;||||0.8090
73860473|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4035||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;||||0.4035
73860474|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6009||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6009
73860475|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7597||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.7597
73860476|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7804||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.7804
73860477|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0463||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0463
73860478|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4951||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.4951
73860479|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.3030
73860480|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.0104
73860481|NCT00468845|147266497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6978||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.6978
73860482|NCT01049802|147266526|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73860483|NCT01049802|147266527|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73860484|NCT01049802|147266528|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
74027523|NCT01855789|147608150|SUPERIORITY||DAS28 Worsening Rate Difference|3.4||||0.4811|TWO_SIDED|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||13.7|-6.9|0.4811
74027524|NCT01855789|147608151|SUPERIORITY||DAS28 Remission Rate Difference|-9.5||||0.1062|TWO_SIDED|95.0|-20.9|1.8|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||1.8|-20.9|0.1062
74027525|NCT01855789|147608151|SUPERIORITY||DAS28 Remission Rate Difference|-6.8||||0.3611|TWO_SIDED|95.0|-18.2|4.6|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||4.6|-18.2|0.3611
74027526|NCT01855789|147608152|SUPERIORITY||Low DAS28 Rate Difference|-13.6||||0.0228|TWO_SIDED|95.0|-24.0|-3.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-3.3|-24.0|0.0228
74027527|NCT01855789|147608152|SUPERIORITY||Low DAS28 Rate Difference|-5.4||||0.3665|TWO_SIDED|95.0|-16.3|5.4|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||5.4|-16.3|0.3665
74027528|NCT01855789|147608153|SUPERIORITY||Estimated Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.21|0.68|||||TCZ + PBO minus TCZ + MTX|ANCOVA model included Week 24 bone erosion as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>/=2.6 to \</=3.2), participant anti-TNF exposure (Yes/No), baseline weight-by-dosing group (\<80 kg q2w, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw).||0.68|-0.21|
74027529|NCT00112151|147608205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.025|TWO_SIDED|||||A one-sided P-value of \<0.025 was used to define statistical significance|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). The primary analysis was conducted in the PRT groups and compared CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.||||<0.025
74027530|NCT00112151|147608205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.025|TWO_SIDED|||||A one-sided P-value of \<0.025 was used to define statistical significance.|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). To address whether the effects of any T on physical function are the same without PRT, the analysis was also conducted in the No PRT groups, comparing CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.||||<0.025
73916650|NCT01059825|147362799|SUPERIORITY_OR_OTHER||Difference in least squares means|-31.79||||0|TWO_SIDED|80.0|-39.02|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.56|-39.02|0.000
73916651|NCT01059825|147362799|SUPERIORITY_OR_OTHER||Difference in least squares means|-23.17||||0|TWO_SIDED|80.0|-30.28|-16.07||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-16.07|-30.28|0.000
73916652|NCT01059825|147362800|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.07||||0|TWO_SIDED|80.0|-28.87|-15.27||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.27|-28.87|0.000
73916653|NCT01059825|147362800|SUPERIORITY_OR_OTHER||Difference in least squares means|-28.51||||0|TWO_SIDED|80.0|-35.35|-21.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-21.67|-35.35|0.000
73916654|NCT01059825|147362800|SUPERIORITY_OR_OTHER||Difference in least squares means|-35.4||||0|TWO_SIDED|80.0|-42.3|-28.51||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-28.51|-42.30|0.000
73916655|NCT01059825|147362800|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.81||||0|TWO_SIDED|80.0|-41.76|-27.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-27.86|-41.76|0.000
73916656|NCT01059825|147362800|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.75||||0|TWO_SIDED|80.0|-29.58|-15.92||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.92|-29.58|0.000
74027531|NCT00112151|147608206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to PRT.||||<0.05
74027532|NCT00112151|147608206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to no PRT.||||<0.05
74086221|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.171|STANDARD_ERROR_OF_MEAN|2.552||0.2161||95.0|-1.874|8.215|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||8.215|-1.874|0.2161
73916657|NCT02495168|147362805|EQUIVALENCE|To show the clinical equivalence, an analysis of covariance (ANCOVA) model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Referece LS Mean Ratio|101.9|||||TWO_SIDED|90.0|92.7|111.9|||||Fieller's formula was applied to calculate the 90% confidence interval (CI) for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.|||111.9|92.7|
73916658|NCT02495168|147362806|SUPERIORITY||LS Mean Difference|2.334|||<|0.0001|TWO_SIDED|95.0|1.673|2.996||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.||2.996|1.673|<0.0001
73916659|NCT02495168|147362806|SUPERIORITY||LS Mean Difference|2.606|||<|0.0001|TWO_SIDED|95.0|1.939|3.273||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.||3.273|1.939|<0.0001
73916660|NCT02495168|147362807|EQUIVALENCE|To show the clinical equivalence, an ANCOVA model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Reference LS Mean Ratio|99.8|||||TWO_SIDED|90.0|87.0|114.5|||||Fieller's formula was applied to calculate the 90% CI for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.|||114.5|87.0|
73916661|NCT02495168|147362808|SUPERIORITY||LS Mean Difference|0.159|||<|0.0001|TWO_SIDED|95.0|0.093|0.226||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.||0.226|0.093|<0.0001
73916662|NCT02495168|147362808|SUPERIORITY||LS Mean Difference|0.164|||<|0.0001|TWO_SIDED|95.0|0.099|0.229||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.||0.229|0.099|<0.0001
73916663|NCT03143894|147362809|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.47|TWO_SIDED||||||t-test, 2 sided|||||||0.47
73916664|NCT03143894|147362810|SUPERIORITY||Mean Difference (Net)|0.69||||0.69|TWO_SIDED||||||t-test, 2 sided|||||||0.69
73916665|NCT03143894|147362811|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
73916666|NCT04626297|147362812|OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|90.0|-10.2|11.2||||||||11.2|-10.2|
73916667|NCT04626297|147362813|OTHER||Risk Difference (RD)|12.2|||||TWO_SIDED|90.0|2.5|22.0||||||||22.0|2.5|
73916668|NCT04626297|147362814|OTHER||Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|10.3|33.2|||Cochran-Mantel-Haenszel|||||33.2|10.3|<0.001
73916669|NCT04626297|147362815|OTHER||Risk Difference (RD)|25.3|||<|0.001|TWO_SIDED|95.0|12.6|38.0|||Cochran-Mantel-Haenszel|||||38|12.6|<0.001
73916670|NCT04626297|147362816|OTHER||Risk Difference (RD)|20.3|||<|0.001|TWO_SIDED|95.0|9.0|31.6|||Cochran-Mantel-Haenszel|||||31.6|9.0|<0.001
73916671|NCT04626297|147362817|OTHER||Risk Difference (RD)|11.9||||0.138|TWO_SIDED|95.0|-3.8|27.5|||Cochran-Mantel-Haenszel|||||27.5|-3.8|0.138
74086222|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.135|STANDARD_ERROR_OF_MEAN|2.548||0.0058||95.0|2.098|12.172|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||12.172|2.098|0.0058
73916672|NCT04626297|147362818|OTHER||LS Mean Difference|-8.21|STANDARD_ERROR_OF_MEAN|2.447|<|0.001|TWO_SIDED|95.0|-13.04|-3.39|||Mixed Models Analysis||The mixed model repeated measures (MMRM) included treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score as fixed factors.|||-3.39|-13.04|<0.001
73916673|NCT04626297|147362819|OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.152||0.001658|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.001658
73916674|NCT02442869|147362828|SUPERIORITY||Net difference in proportion|1.73||||0.19|TWO_SIDED|95.0|-2.41|15.35|||Chi-squared|Df (1)|NNT = 5.59|Due to the large number of zeroes in the Suicidal Ideation (SI)-Current Subscale of the SSI at post (over a third of the participants reported no SI at the end of treatment), a zero-altered model was utilized which divided the outcome into (1) the probability of any SI and (2) the intensity of SI when non-zero, as done in other studies. This analysis tested the difference between the CAMS and TAU arms based on number of participants reporting no SI post Stage 1 treatment.||15.35|-2.41|0.19
73916675|NCT02442869|147362829|SUPERIORITY||Net difference in proportion|1.3||||0.25|TWO_SIDED||||||Regression, Logistic|||||||0.25
73916676|NCT02442869|147362830|SUPERIORITY|Power analyses. We determined that with a sample size of 62 clients, the outcome analyses had at least 80% power to detect an effect size of 0.80 (Ahn etal., 2001)|Mean Difference (Net)|0.55||||0.035|TWO_SIDED|95.0|0.04|1.05|||t-test, 2 sided|t(60) = 2.15||||1.05|0.04|0.035
73916677|NCT03521934|147362831|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.52|0.85|||Cox proportional hazards model|||The estimates of the hazard ratio (HR) and corresponding 2-sided 95% confidence interval (CI) was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-cardiovascular (non-CV) death treated as a competing event.||0.85|0.52|< 0.001
73916678|NCT03521934|147362832|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.001|TWO_SIDED|95.0|0.49|0.83|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.83|0.49|< 0.001
73916679|NCT03521934|147362833|SUPERIORITY||Hazard Ratio (HR)|0.84|||=|0.36|TWO_SIDED|95.0|0.58|1.22|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.22|0.58|= 0.36
73916680|NCT03521934|147362834|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.56|0.92||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.92|0.56|
74027533|NCT00112151|147608207|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to PRT.||||<0.05
74027534|NCT00112151|147608207|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to no PRT.||||<0.05
74027535|NCT00112151|147608208|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to PRT.||||<0.05
74027536|NCT00112151|147608208|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to no PRT.||||<0.05
74027537|NCT00112151|147608209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.||||<0.05
74027538|NCT00112151|147608209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.||||<0.05
74027539|NCT00112151|147608210|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.||||<0.05
74086223|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.185|STANDARD_ERROR_OF_MEAN|3.993||0.1283||95.0|-1.853|14.223|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||14.223|-1.853|0.1283
74027540|NCT00112151|147608210|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.||||<0.05
74027541|NCT00435539|147608217|SUPERIORITY_OR_OTHER|||||||0.4783|||||||Fisher Exact|||||||0.4783
74027542|NCT00435539|147608217|SUPERIORITY_OR_OTHER|||||||0.0932|||||||Fisher Exact|||||||0.0932
74027543|NCT00435539|147608217|SUPERIORITY_OR_OTHER|||||||0.0721|||||||Fisher Exact|||||||0.0721
74027544|NCT00435539|147608218|SUPERIORITY_OR_OTHER|||||||0.4762|||||||Fisher Exact|||||||0.4762
74027545|NCT00435539|147608218|SUPERIORITY_OR_OTHER|||||||0.4762|||||||Fisher Exact|||||||0.4762
74027546|NCT00435539|147608218|SUPERIORITY_OR_OTHER|||||||0.5343|||||||Fisher Exact|||||||0.5343
74027547|NCT02839746|147608236|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 2.||||<0.0001
74027548|NCT02839746|147608236|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline satisfaction with that of Visit 2.||||<0.0001
74027549|NCT02839746|147608237|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 3.||||<0.0001
74027550|NCT02839746|147608237|OTHER|Within group comparison of Baseline satisfaction with that of Visit 3.|||||<|0.0001|||||||non-parametric Wilcoxon signed-rank]|||||||<0.0001
74027551|NCT02839746|147608238|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 convenience with that of Visit 3.||||<0.0001
74027552|NCT02839746|147608238|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 satisfaction with that of Visit 3.||||<0.0001
74086224|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.173|STANDARD_ERROR_OF_MEAN|4.033||0.008||95.0|3.056|19.291|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||19.291|3.056|0.0080
73860485|NCT01049802|147266529|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73860486|NCT01049802|147266530|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73860487|NCT05320393|147266578|OTHER|This study was not powered for formal hypothesis testing; analyses were intended for interpretation purposes only. Analysis was performed using the modified Intent-to-Treat population and regardless of responder status.||||||0.0109|TWO_SIDED|95.0|||||Log Rank|||The primary effectiveness endpoint was a measure of duration of effect, described by Kaplan-Meier curves and the median times, with associated 2-sided 95% confidence intervals for each treatment group.||||0.0109
73860488|NCT05693922|147266579|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.34
73860489|NCT05693922|147266580|SUPERIORITY|||||||0.54|||||||ANOVA|||||||0.54
73860490|NCT05693922|147266581|SUPERIORITY|||||||0.865|||||||ANOVA|||||||0.865
73860491|NCT03559699|147266586|OTHER|||||||0.0002|TWO_SIDED|95.0||||1-sided P-value|Binomial exact test|||||||0.0002
73860492|NCT01460719|147266663|OTHER|The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the GMFR is \>1.0.|||||<|0.001|||||||Single longitudinal regression model|Adjustments made for pre-vaccination values||||||<0.001
73860493|NCT01151761|147266670|SUPERIORITY_OR_OTHER||months|8.5|||||TWO_SIDED|95.0|7.0|10.0|||||There were only two patients in the study. Both died without having any local failure. One patient died at 10 months, the other at 7 months. The range for the 95%CI is both the full range and the 95%CI.|The median Progression Free Survival (PFS) time as calculated using Kaplan Meier methodology. For PFS both death and progression are counted as events.||10|7|
73860494|NCT01151761|147266675|SUPERIORITY_OR_OTHER||proportion of participants|0.0|||||TWO_SIDED||||||||None of the two patients who participated had a local recurrence before they died.|||||
73916681|NCT03521934|147362835|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.54|0.86||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.86|0.54|
73916682|NCT03521934|147362836|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.59|1.14||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction.||1.14|0.59|
73916683|NCT03521934|147362837|SUPERIORITY||Hazard Ratio (HR)|4.1|||||TWO_SIDED|95.0|1.3|7.0||||||The change from baseline to Month 4 was analyzed using an ANCOVA model with treatment groups as factor and baseline KCCQ-12 score and randomization stratification factors as covariates.||7|1.3|
73916684|NCT03521934|147362838|SUPERIORITY||Difference in Least Squares Means|-0.16|||||TWO_SIDED|95.0|-1.3|0.98||||||Rate of decline in eGFR observed over time was analyzed by MMRM with absolute change in eGFR from baseline as the outcome, a random effect for intercept, and fixed effects for treatment, baseline value, and time.||0.98|-1.3|
73916685|NCT03462082|147362897|SUPERIORITY|||||||0.163||||||"Holm-adjusted P-Value: 0.326~\*Gait Velocity for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.163
73916686|NCT03462082|147362897|SUPERIORITY|||||||0.749||||||"Holm-adjusted P-Value: 0.749~\*Gait Velocity for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.749
73916687|NCT03462082|147362898|SUPERIORITY|||||||0.031||||||"Holm-adjusted P-Value: 0.155~\*MDS-UPDRS (total) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions.||||0.031
73916688|NCT03462082|147362898|SUPERIORITY|||||||0.778||||||"Holm-adjusted P-Value: 0.902~\*MDS-UPDRS total for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions.||||0.778
73916689|NCT03462082|147362898|SUPERIORITY|||||||0.039||||||"Holm-adjusted P-Value: 0.157~\*MDS-UPDRS (motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.039
73916690|NCT03462082|147362898|SUPERIORITY|||||||0.451||||||"Holm-adjusted P-Value: 0.902~\*MDS-UPDRS (motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.451
73916691|NCT03462082|147362898|SUPERIORITY|||||||0.111||||||"Holm-adjusted P-Value: 0.333~\*MDS-UPDRS (axial motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.111
73916692|NCT03462082|147362898|SUPERIORITY|||||||0.005||||||"Holm-adjusted P-Value: 0.030~\*MDS-UPDRS (axial motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.005
73916693|NCT03462082|147362899|SUPERIORITY|||||||0.984||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.984
73916694|NCT03462082|147362899|SUPERIORITY|||||||0.067||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.067
73916695|NCT03462082|147362900|SUPERIORITY|||||||0.44||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.440
73916696|NCT03462082|147362900|SUPERIORITY|||||||0.051||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.051
73916697|NCT03462082|147362901|SUPERIORITY|||||||0.945||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.945
73916698|NCT03462082|147362901|SUPERIORITY|||||||0.024||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.024
73916699|NCT03462082|147362902|SUPERIORITY|||||||0.097||||||"Holm-adjusted P-Value: 1.00~\*Gait velocity for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.097
73916700|NCT03462082|147362902|SUPERIORITY|||||||0.75||||||"Holm-adjusted P-Value: 1.00~\*Gait velocity for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.750
73916701|NCT03462082|147362903|SUPERIORITY|||||||0.128||||||"Holm-adjusted P-Value: 1.00~\*Step length (mean) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.128
73916702|NCT03462082|147362903|SUPERIORITY|||||||0.117||||||"Holm-adjusted P-Value: 1.00~\*Step length (mean) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.117
73916703|NCT03462082|147362903|SUPERIORITY|||||||0.145||||||"Holm-adjusted P-Value: 1.00~\*Step length (right) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.145
73966515|NCT03655132|147469410|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|14.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.001
73966516|NCT03655132|147469411|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.5||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.13
73966517|NCT03655132|147469411|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|3.0||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.07
73966518|NCT03655132|147469412|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.0||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.64
73966519|NCT03655132|147469412|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|-0.3||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.30
73966520|NCT03655132|147469413|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.5||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.75
73966521|NCT03655132|147469413|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|-0.5||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.60
74027553|NCT03065530|147608394|OTHER||||||<|0.05|||||||Kruskal-Wallis|||The sample size was calculated on the basis of an our initial pilot study, and the SD was 1.4 between the four groups. We hypothesized that the differences in VAS between the four groups and the SDs would be 15%. A power analysis suggested that there will be 80% power to detect differences at an α=0.05 significance level (two-tailed), including 24 individuals per treatment group. Considering the exclusion of 25% of patients, 30 parturients were eventually recruited in each group.||||<0.05
74027554|NCT00479466|147608439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.6|||<|0.001|TWO_SIDED|95.0|-44.0|-17.3|||ANCOVA|||||-17.3|-44.0|<0.001
74086225|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.941|STANDARD_ERROR_OF_MEAN|2.15||0.0018||95.0|7.414|18.468|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||18.468|7.414|0.0018
74086226|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.941|STANDARD_ERROR_OF_MEAN|3.533||0.0038||95.0|8.859|27.023|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||27.023|8.859|0.0038
73860495|NCT02838901|147266684|OTHER|This was a descriptive analysis, and was based on the overall assessment of feasibility of the intervention.||||||0.058||||||The p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The null hypothesis was used, and the assumption was there would be no difference in adherence between the Active Juice and the Placebo Juice, and therefore a two-sided t approximation was reported. Since this was a pilot study, power calculations were not performed. The adherence in the two groups was compared using the Wilcoxon two-sample test.||||0.058
73860496|NCT02838901|147266685|OTHER|This was a descriptive analysis and was under the goal of assessing safety of the intervention.||||||1|||||||Fisher Exact|||Null hypothesis was assumed, no power calculation was done since this was a pilot study.||||1.00
73860497|NCT02838901|147266686|OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study.||||0.0003
73860498|NCT02838901|147266687|OTHER|This was a descriptive analysis for a pilot study, and no power calculations were performed.||||||0.1023|||||||Wilcoxon (Mann-Whitney)|||||||0.1023
73860499|NCT02838901|147266688|OTHER|This was a descriptive analysis for a pilot study to gather preliminary data for a larger trial. No power calculations were performed for this outcome.||||||0.9581|||||||Wilcoxon (Mann-Whitney)|||||||.9581
73966522|NCT05568004|147469415|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.|||Statistical analysis was conducted by a researcher using the Statistical Package for Social Sciences (SPSS) version 26.0. The Shapiro-Wilk test and histograms evaluated the data for normal distribution, and the Levene test confirmed homogeneous variances between groups (p \> 0.05). Continuous data following a normal distribution are presented as mean ± standard deviation (SD). The independent samples t test or Mann-Whitney U test was used to compare independent continuous data between groups, while the chi-square or Fisher's exact test was used to compare categorical data. Friedman two-way ANOVA was used to analyze dependent variables, while the two-way mixed ANOVA was used to examine the changes between groups over time. Before the two-way mixed ANOVA, boxplot evaluation confirmed no outliers. Mauchly's sphericity test showed that the assumption of sphericity for two-way interaction was met. Tukey's correction was used for pairwise subgroup comparisons.|||0.001
73966523|NCT05568004|147469415|SUPERIORITY|||||||0.001|||||||ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.||||0.001
73966524|NCT05568004|147469415|SUPERIORITY|||||||0.166||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.166
73966525|NCT05568004|147469416|SUPERIORITY|||||||0.074||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.074
73966526|NCT05568004|147469416|SUPERIORITY|A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.||||||0.074|||||||ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.074
73966527|NCT05568004|147469416|SUPERIORITY|||||||0.311||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.311
73966528|NCT05568004|147469417|SUPERIORITY|||||||0.018||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.018
73966529|NCT05568004|147469417|SUPERIORITY|||||||0.152||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.152
74027555|NCT00479466|147608439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.6|||<|0.001|TWO_SIDED|95.0|-59.7|-33.4|||ANCOVA|||||-33.4|-59.7|<0.001
73916704|NCT03462082|147362903|SUPERIORITY|||||||0.056||||||"Holm-adjusted P-Value: 1.00~\*Step length (right) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.056
73916705|NCT03462082|147362903|SUPERIORITY|||||||0.151||||||"Holm-adjusted P-Value: 1.00~\*Step length (left) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.151
73916706|NCT03462082|147362903|SUPERIORITY|||||||0.129||||||"Holm-adjusted P-Value: 1.00~\*Step length (left) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.129
73916707|NCT03462082|147362903|SUPERIORITY|||||||0.698||||||"Holm-adjusted P-Value: 1.00~\*Step length difference for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.698
73916708|NCT03462082|147362903|SUPERIORITY|||||||0.779||||||"Holm-adjusted P-Value: 1.00~\*Step length difference for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.779
74027556|NCT00479466|147608439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.1|||<|0.001|TWO_SIDED|95.0|-64.3|-38.0|||ANCOVA|||||-38.0|-64.3|<0.001
74027557|NCT00479466|147608439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.2|||<|0.001|TWO_SIDED|95.0|-74.6|-47.8|||ANCOVA|||||-47.8|-74.6|<0.001
73916709|NCT03462082|147362904|SUPERIORITY|||||||0.874||||||"Holm-adjusted P-Value: 1.00~\*Step length ratio for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.874
73916710|NCT03462082|147362904|SUPERIORITY|||||||0.976||||||"Holm-adjusted P-Value: 1.00~\*Step length ratio for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.976
73966530|NCT05568004|147469417|SUPERIORITY|||||||0.438||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.438
73971367|NCT05192109|147483238|OTHER|||||||0.93||||||This is the p-value for the simple effect of diagnostic group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||0.93
73971368|NCT05192109|147483238|OTHER||||||<|0.01||||||This is the p-value for the interaction between condition and group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
73971369|NCT05192109|147483239|OTHER||||||<|0.01||||||This is the p-value for the simple effect of condition.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
74027558|NCT00479466|147608439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|||<|0.001|TWO_SIDED|95.0|-48.6|-22.4|||ANCOVA|||||-22.4|-48.6|<0.001
74027559|NCT00479466|147608440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.001|TWO_SIDED|95.0|-1.53|-0.76|||ANCOVA|||||-0.76|-1.53|<0.001
74027560|NCT00479466|147608440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53|||<|0.001|TWO_SIDED|95.0|-1.91|-1.15|||ANCOVA|||||-1.15|-1.91|<0.001
74027561|NCT00479466|147608440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|||<|0.001|TWO_SIDED|95.0|-2.07|-1.31|||ANCOVA|||||-1.31|-2.07|<0.001
74027562|NCT00479466|147608440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.45|-1.68|||ANCOVA|||||-1.68|-2.45|<0.001
74027563|NCT00479466|147608440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-1.7|-0.95|||ANCOVA|||||-0.95|-1.70|<0.001
74027564|NCT00479466|147608441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.8|||<|0.001|TWO_SIDED|95.0|-79.4|-34.3|||ANCOVA|||||-34.3|-79.4|<0.001
74027565|NCT00479466|147608441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.0|||<|0.001|TWO_SIDED|95.0|-91.8|-48.2|||ANCOVA|||||-48.2|-91.8|<0.001
74027566|NCT00479466|147608441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-87.4|||<|0.001|TWO_SIDED|95.0|-109.4|-65.3|||ANCOVA|||||-65.3|-109.4|<0.001
74027567|NCT00479466|147608441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.6|||<|0.001|TWO_SIDED|95.0|-124.2|-79.1|||ANCOVA|||||-79.1|-124.2|<0.001
74027568|NCT00479466|147608441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.8|||<|0.001|TWO_SIDED|95.0|-82.7|-38.8|||ANCOVA|||||-38.8|-82.7|<0.001
73966531|NCT05568004|147469418|SUPERIORITY|||||||0.135||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.135
73966532|NCT05568004|147469418|SUPERIORITY|||||||0.203||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.203
73966533|NCT05568004|147469418|SUPERIORITY|||||||0.593||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.593
74027569|NCT02255838|147608446|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|paired t-test||||||<0.05
74027570|NCT00906789|147608467|NON_INFERIORITY_OR_EQUIVALENCE|Given a continuous confidence score (0-100), the trapezoidal method was used to obtain the area under the LROC with bootstrapping at 10,000 iterations to obtain the 95% confidence interval (CI). Acceptance criteria for tests of non-inferiority and superiority were previously set at 95% CI upper bound of ΔAUCUA-SV less than δ=0.1 and δ=0, respectively. If the 95% CI upper bound difference of UA-SV is less than 0.1, then SV is non-inferior. If it is 0 or less than 0, then SV is superior.||||||0.05|||||||Bootstraping|||The sample size of 351 patients, in a 2:1 ratio of nodule absent to present patients was selected to provide 80% power to detect a difference in areas under the curve of 0.10 or greater. This sample size was calculated using PASS software (Hintze, 2008). Settings: • α = 0.025. • one-sided test • AUCA = 0.80 and AUCSV = 0.90.• 2:1 ratio of patients with nodules to those without • areas calculated for the entire curves • correlation 0.3\* • discrete data. • standard deviation ratios of 1\*.||||0.05
74027571|NCT02334267|147608470|SUPERIORITY_OR_OTHER||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis|||||||<0.0001
74027572|NCT02334267|147608471|SUPERIORITY_OR_OTHER|||||||0.4||||||trend analysis over time|Mixed Models Analysis|||||||0.4
74027573|NCT02334267|147608472|SUPERIORITY_OR_OTHER|||||||0.003||||||trend analysis over time|Mixed Models Analysis|||||||0.003
74027574|NCT02334267|147608473|SUPERIORITY_OR_OTHER||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis|||||||<0.0001
74027575|NCT02052960|147608474|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.86|TWO_SIDED|95.0|0.736|1.359|||Log Rank|||||1.359|0.736|0.86
74027576|NCT02052960|147608475|SUPERIORITY||Mean Difference (Net)|-1.9||||0.77|TWO_SIDED|95.0|-14.5|10.7|||Chi-squared|||||10.7|-14.5|0.77
74027577|NCT02052960|147608476|SUPERIORITY||Mean Difference (Net)|-1.21||||0.83|TWO_SIDED|95.0|-12.05|9.63|||Chi-squared|||||9.63|-12.05|0.83
74086227|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.125|STANDARD_ERROR_OF_MEAN|2.115||0.5953||95.0|-3.045|5.296|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||5.296|-3.045|0.5953
74086228|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.331|STANDARD_ERROR_OF_MEAN|2.172||0.1267||95.0|-0.952|7.613|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||7.613|-0.952|0.1267
74086229|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.617|STANDARD_ERROR_OF_MEAN|2.339||0.2647||95.0|-1.997|7.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||7.231|-1.997|0.2647
74086230|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.771|STANDARD_ERROR_OF_MEAN|2.421||0.0181||95.0|0.995|10.548|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.548|0.995|0.0181
74086231|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.374|STANDARD_ERROR_OF_MEAN|2.299||0.5507||95.0|-3.161|5.91|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||5.910|-3.161|0.5507
74027578|NCT02052960|147608477|SUPERIORITY||Hazard Ratio (HR)|1.057||||0.7|TWO_SIDED|95.0|0.814|1.372|||Log Rank|||||1.372|0.814|0.70
74027579|NCT02052960|147608478|SUPERIORITY||Hazard Ratio (HR)|1.012||||0.96|TWO_SIDED|95.0|0.734|1.396|||Log Rank|||||1.396|0.734|0.96
74027580|NCT03114969|147608600|SUPERIORITY||Odds Ratio (OR)|4.657||||0.005|TWO_SIDED|95.0|1.584|13.686||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||13.686|1.584|0.005
74027581|NCT03114969|147608600|SUPERIORITY||Odds Ratio (OR)|2.478||||0.114|TWO_SIDED|95.0|0.805|7.632||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.632|0.805|0.114
74027582|NCT03114969|147608600|SUPERIORITY||Odds Ratio (OR)|3.499||||0.026|TWO_SIDED|95.0|1.16|10.555||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||10.555|1.160|0.026
74027583|NCT03114969|147608600|SUPERIORITY||Odds Ratio (OR)|3.943||||0.012|TWO_SIDED|95.0|1.348|11.534||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||11.534|1.348|0.012
74027584|NCT03114969|147608600|SUPERIORITY||Odds Ratio (OR)|1.223||||0.746|TWO_SIDED|95.0|0.361|4.151||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.151|0.361|0.746
74027585|NCT03114969|147608600|SUPERIORITY||Odds Ratio (OR)|5.562||||0.001|TWO_SIDED|95.0|1.932|16.013||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||16.013|1.932|0.001
74086232|NCT00442546|147725988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.404|STANDARD_ERROR_OF_MEAN|2.393||0.3164||95.0|-2.317|7.124|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||7.124|-2.317|0.3164
73916711|NCT03462082|147362904|SUPERIORITY|||||||0.859||||||"Holm-adjusted P-Value: 1.00~\*Step length symmetry for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.859
73916712|NCT03462082|147362904|SUPERIORITY|||||||0.86||||||"Holm-adjusted P-Value: 1.00~\*Step length symmetry for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.860
74027586|NCT03114969|147608600|SUPERIORITY||Odds Ratio (OR)|2.979||||0.05|TWO_SIDED|95.0|0.999|8.882||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||8.882|0.999|0.050
74027587|NCT03114969|147608600|SUPERIORITY||Odds Ratio (OR)|4.418||||0.006|TWO_SIDED|95.0|1.521|12.834||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||12.834|1.521|0.006
74027588|NCT03114969|147608600|SUPERIORITY||Odds Ratio (OR)|4.165||||0.009|TWO_SIDED|95.0|1.425|12.178||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||12.178|1.425|0.009
74027589|NCT03114969|147608600|SUPERIORITY||Odds Ratio (OR)|1.209||||0.761|TWO_SIDED|95.0|0.357|4.095||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.095|0.357|0.761
74027590|NCT03114969|147608601|SUPERIORITY||Odds Ratio (OR)|2.292||||0.1|TWO_SIDED|95.0|0.853|6.163||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||6.163|0.853|0.100
74027591|NCT03114969|147608601|SUPERIORITY||Odds Ratio (OR)|2.642||||0.051|TWO_SIDED|95.0|0.994|7.022||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.022|0.994|0.051
74027592|NCT03114969|147608602|SUPERIORITY||Odds Ratio (OR)|3.995|||<|0.001|TWO_SIDED|95.0|1.808|8.829||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||8.829|1.808|<0.001
74027593|NCT03114969|147608602|SUPERIORITY||Odds Ratio (OR)|2.181||||0.069|TWO_SIDED|95.0|0.94|5.059||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.059|0.940|0.069
74027594|NCT03114969|147608602|SUPERIORITY||Odds Ratio (OR)|4.855|||<|0.001|TWO_SIDED|95.0|2.339|10.08||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||10.080|2.339|<0.001
74027595|NCT03114969|147608602|SUPERIORITY||Odds Ratio (OR)|2.71||||0.01|TWO_SIDED|95.0|1.274|5.764||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.764|1.274|0.010
74027596|NCT03114969|147608603|SUPERIORITY||Odds Ratio (OR)|2.503||||0.108|TWO_SIDED|95.0|0.818|7.659||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.659|0.818|0.108
74027597|NCT03114969|147608603|SUPERIORITY||Odds Ratio (OR)|2.409||||0.122|TWO_SIDED|95.0|0.792|7.331||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.331|0.792|0.122
74027598|NCT03114969|147608604|SUPERIORITY||Odds Ratio (OR)|4.887||||0.001|TWO_SIDED|95.0|1.851|12.903||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||12.903|1.851|0.001
74027599|NCT03114969|147608604|SUPERIORITY||Odds Ratio (OR)|5.484|||<|0.001|TWO_SIDED|95.0|2.106|14.284||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||14.284|2.106|<0.001
74027600|NCT03114969|147608605|SUPERIORITY||Odds Ratio (OR)|3.941|||<|0.001|TWO_SIDED|95.0|1.863|8.337||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||8.337|1.863|<0.001
74086233|NCT00442546|147725989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4365||95.0|||||Log Rank|||||||0.4365
73916713|NCT03462082|147362905|SUPERIORITY|||||||0.04||||||"Holm-adjusted P-Value: 0.480~\*Pitch (minimum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.040
73916714|NCT03462082|147362905|SUPERIORITY|||||||0.883||||||"Holm-adjusted P-Value: 1.00~\*Pitch (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.883
73916715|NCT03462082|147362905|SUPERIORITY|||||||0.071||||||"Holm-adjusted P-Value: 0.781~\*Pitch (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.071
73916716|NCT03462082|147362905|SUPERIORITY|||||||0.327||||||"Holm-adjusted P-Value: 1.00~\*Pitch (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.327
73916717|NCT03462082|147362906|SUPERIORITY|||||||0.487||||||"Holm-adjusted P-Value: 1.00~\*Loudness (minimum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.487
73916718|NCT03462082|147362906|SUPERIORITY|||||||0.861||||||"Holm-adjusted P-Value: 1.00~\*Loudness (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.861
73916719|NCT03462082|147362906|SUPERIORITY|||||||0.411||||||"Holm-adjusted P-Value: 1.00~\*Loudness (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.411
73916720|NCT03462082|147362906|SUPERIORITY|||||||0.997||||||"Holm-adjusted P-Value: 1.00~\*Loudness (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.997
73916721|NCT03462082|147362907|SUPERIORITY|||||||0.388||||||"Holm-adjusted P-Value: 1.00~\*Jitter for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.388
73916722|NCT03462082|147362907|SUPERIORITY|||||||0.684||||||"Holm-adjusted P-Value: 1.00~\*Jitter for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.684
73916723|NCT03462082|147362908|SUPERIORITY|||||||0.85||||||"Holm-adjusted P-Value: 1.00~\*Shimmer for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.850
73916724|NCT03462082|147362908|SUPERIORITY|||||||0.712||||||"Holm-adjusted P-Value: 1.00~\*Shimmer for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.712
73916725|NCT03462082|147362909|SUPERIORITY|||||||0.501|||||||Mixed Models Analysis|Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.501
74086234|NCT00442546|147725989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4023||95.0|||||Log Rank|||||||0.4023
74086235|NCT00442546|147725990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4024||95.0|||||Log Rank|||||||0.4024
74086236|NCT00442546|147725990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.191||95.0|||||Log Rank|||||||0.1910
74086237|NCT00442546|147725991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.347|STANDARD_ERROR_OF_MEAN|2.497||0.3483||95.0|-2.573|7.268|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||7.268|-2.573|0.3483
74086238|NCT00442546|147725991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.155|STANDARD_ERROR_OF_MEAN|2.498||0.2078||95.0|-1.766|8.077|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.077|-1.766|0.2078
74086239|NCT00442546|147725991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.126|STANDARD_ERROR_OF_MEAN|6.436||0.4299||95.0|-7.836|18.088|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||18.088|-7.836|0.4299
74086240|NCT00442546|147725991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.146|STANDARD_ERROR_OF_MEAN|6.726||0.4482||95.0|-8.4|18.693|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||18.693|-8.400|0.4482
74086241|NCT00442546|147725991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.036|STANDARD_ERROR_OF_MEAN|4.426||0.6472||95.0|-6.818|10.89|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.890|-6.818|0.6472
74086242|NCT00442546|147725991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.156|STANDARD_ERROR_OF_MEAN|4.642||0.4992||95.0|-6.129|12.442|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||12.442|-6.129|0.4992
74086243|NCT00442546|147725991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.656|STANDARD_ERROR_OF_MEAN|5.149||0.6072||95.0|-7.578|12.891|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||12.891|-7.578|0.6072
74086244|NCT00442546|147725991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.963|STANDARD_ERROR_OF_MEAN|4.906||0.3146||95.0|-4.789|14.714|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||14.714|-4.789|0.3146
73916726|NCT03462082|147362909|SUPERIORITY|||||||0.216||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.216
74086245|NCT00442546|147725992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.177|STANDARD_ERROR_OF_MEAN|2.326||0.0739||95.0|-0.407|8.76|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.760|-0.407|0.0739
74086246|NCT00442546|147725992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.176|STANDARD_ERROR_OF_MEAN|2.327||0.074||95.0|-0.409|8.761|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.761|-0.409|0.0740
74086247|NCT00442546|147725992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.298|STANDARD_ERROR_OF_MEAN|6.418||0.2615||95.0|-5.628|20.224|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||20.224|-5.628|0.2615
74086248|NCT00442546|147725992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.286|STANDARD_ERROR_OF_MEAN|6.707||0.6266||95.0|-10.22|16.795|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||16.795|-10.22|0.6266
73916727|NCT03462082|147362910|SUPERIORITY||||||>|0.05||||||Non-adjusted P-Values were \>0.05 and Holm-adjusted P-Values were 1.00 for all comparisons, except for the Hopkins Verbal Learning Test-Revised: Delayed Recall. For this test, the non-adjusted P-Value was 0.04 and the Holm-adjusted P-Value was 0.44.|Friedman test|Using ranks for repeated measures (3 conditions)||||||>0.05
73971370|NCT05192109|147483239|OTHER|||||||0.22||||||This is the p-value for the simple effect of group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||0.22
74086249|NCT00442546|147725992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.17|STANDARD_ERROR_OF_MEAN|3.958||0.2963||95.0|-3.747|12.086|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||12.086|-3.747|0.2963
74086250|NCT00442546|147725992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.248|STANDARD_ERROR_OF_MEAN|4.151||0.1375||95.0|-2.054|14.55|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||14.550|-2.054|0.1375
74086251|NCT00442546|147725992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.431|STANDARD_ERROR_OF_MEAN|4.895||0.2703||95.0|-4.298|15.161|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||15.161|-4.298|0.2703
74086252|NCT00442546|147725992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.663|STANDARD_ERROR_OF_MEAN|4.664||0.104||95.0|-1.607|16.933|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||16.933|-1.607|0.1040
74086253|NCT00442546|147725993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.579|STANDARD_ERROR_OF_MEAN|3.154||0.8545||95.0|-5.635|6.793|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||6.793|-5.635|0.8545
74086254|NCT00442546|147725993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.128|STANDARD_ERROR_OF_MEAN|3.155||0.5006||95.0|-4.088|8.344|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.344|-4.088|0.5006
74086255|NCT00442546|147725993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.956|STANDARD_ERROR_OF_MEAN|8.248||0.7217||95.0|-13.66|19.569|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||19.569|-13.66|0.7217
74086256|NCT00442546|147725993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.011|STANDARD_ERROR_OF_MEAN|8.62||0.4203||95.0|-10.35|24.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||24.372|-10.35|0.4203
74086257|NCT00442546|147725993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|5.6||0.9859||95.0|-11.3|11.102|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||11.102|-11.30|0.9859
73916728|NCT01425281|147362916|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Angiographic vasomotion reactivity following nitrate administration, the test was analyzable for 388 paired lesions (Absorb arm \[258 lesions\] vs Xience arm \[130 lesions\]).||||0.49
73916729|NCT01425281|147362917|NON_INFERIORITY|Using t-test with non-inferiority margin of 0.140mm||||||0.78|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Follow-up angiographic analysis was available for 298 lesions in the Absorb arm and 151 lesions in the Xience arm.||||0.78
74086258|NCT00442546|147725993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|5.873||0.9915||95.0|-11.68|11.811|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||11.811|-11.68|0.9915
74086259|NCT00442546|147725993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|6.508||0.9843||95.0|-13.06|12.808|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||12.808|-13.06|0.9843
74086260|NCT00442546|147725993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.351|STANDARD_ERROR_OF_MEAN|6.201||0.7055||95.0|-9.974|14.677|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||14.677|-9.974|0.7055
73916730|NCT03454997|147363022|SUPERIORITY||Mean Difference (Net)|5.5|||||TWO_SIDED|95.0|3.9|7.1||||||comparison of baseline and 6 months across both groups||7.1|3.9|
73916731|NCT03454997|147363022|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.3|1.1||||||between groups differences of change between baseline and 6 months||1.1|-2.3|
73916732|NCT03454997|147363023|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.4|0.4||||||leading behavioral weight loss group baseline to 6 months comparison||0.4|-1.4|
73916733|NCT03454997|147363023|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-2.0|1.0||||||leading behavioral weight loss group between group comparison of change||1.0|-2.0|
73916734|NCT03454997|147363023|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.4|0.2||||||completing weight ins baseline to 6 month comparison||0.2|-1.4|
73916735|NCT03454997|147363023|SUPERIORITY||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-2.5|0.5||||||completing weigh ins between groups comparison of change||0.5|-2.5|
73916736|NCT03454997|147363023|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.2|0.3||||||managing a group session baseline to 6 months comparison||0.3|-1.2|
73916737|NCT03454997|147363023|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-2.0|1.1||||||managing a group session between groups comparison of change||1.1|-2.0|
73916738|NCT03454997|147363024|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-2.0|2.9||||||comparison between baseline and 6 months across groups||2.9|-2.0|
73916739|NCT03454997|147363024|SUPERIORITY||Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-9.1|0.8||||||between groups comparison of change post training to 6 months||0.8|-9.1|
73916740|NCT03454997|147363025|SUPERIORITY||Mean Difference (Net)|-3.3|||||TWO_SIDED|95.0|-6.9|0.3||||||comparison of baseline to 6 months across both groups||0.3|-6.9|
73916741|NCT03454997|147363025|SUPERIORITY||Mean Difference (Net)|-4.8|||||TWO_SIDED|95.0|-11.4|1.8||||||comparison of between group differences baseline to 6 months||1.8|-11.4|
73916742|NCT03454997|147363026|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.4|1.1||||||Comparison of Baseline \& 6 Months across both groups||1.1|-0.4|
73966534|NCT05568004|147469419|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.001
73966535|NCT05568004|147469419|SUPERIORITY|||||||0.021||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.021
74086261|NCT00442546|147725994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.315||0.9405||95.0|-0.614|0.661|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.661|-0.614|0.9405
74086262|NCT00442546|147725994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.287||0.5641||95.0|-0.749|0.415|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.415|-0.749|0.5641
73916743|NCT03454997|147363026|SUPERIORITY||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-2.0|0.2||||||Between Groups Differences of Change between Baseline \& 6 Months||0.2|-2.0|
73916744|NCT03454997|147363027|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-4.5|3.3||||||comparison of between group differences baseline to 6 months||3.3|-4.5|
73916745|NCT03454997|147363027|SUPERIORITY||Mean Difference (Net)|-1.6|||||TWO_SIDED|95.0|-3.1|0.2||||||comparison of baseline to 6 months across groups||0.2|-3.1|
73916746|NCT03454997|147363028|SUPERIORITY||Mean Difference (Net)|-3.8|||||TWO_SIDED|95.0|-6.1|-1.6||||||comparison of baseline and 6 months across groups||-1.6|-6.1|
73916747|NCT03454997|147363028|SUPERIORITY||Mean Difference (Net)|-6.6|||||TWO_SIDED|95.0|-20.2|6.9||||||between groups differences of change between baseline to 6 months||6.9|-20.2|
73916748|NCT00299975|147363034|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis.||||||<0.05
73916749|NCT00299975|147363035|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis.||||||<0.05
73916750|NCT00299975|147363036|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
73916751|NCT00299975|147363037|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
73916752|NCT00299975|147363038|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between three treatment groups in each time frame.||||||<0.05
73916753|NCT00299975|147363039|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
73916754|NCT00299975|147363040|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
73916755|NCT00299975|147363041|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
73916756|NCT00299975|147363042|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
73916757|NCT00299975|147363043|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
73916758|NCT00299975|147363044|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
73916759|NCT00299975|147363046|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
73916760|NCT00299975|147363047|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
73916761|NCT00299975|147363048|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
73916762|NCT00299975|147363049|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
74086263|NCT00442546|147725994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||2.181|-1.181|0.5226
74086264|NCT00442546|147725994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.823|-2.156|0.8557
74086265|NCT00442546|147725994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.328|STANDARD_ERROR_OF_MEAN|0.882||0.1925||95.0|-3.596|0.94|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.940|-3.596|0.1925
73916763|NCT03167411|147363052|EQUIVALENCE|The ratio of the least squares (LS) geometric means of Cmax when bexagliflozin is dosed in combination with exenatide versus when dosed alone, with 80-125% defined as the lack of interaction boundaries. 90% confidence intervals was constructed.|Point Estimate (%)|125.27|||||TWO_SIDED|90.0|104.45|150.24|||||Estimated ratio (%) of exponentiated mean difference of log-transformed PK parameter from ANOVA (linear mixed-effects model), with treatment, period, and sequence as fixed effects, and subject as a random effect.|||150.24|104.45|
74086266|NCT00442546|147725994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.982||0.9654||95.0|-2.568|2.479|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||2.479|-2.568|0.9654
74086267|NCT00442546|147725994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.352|STANDARD_ERROR_OF_MEAN|1.782||0.235||95.0|-6.712|2.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.008|-6.712|0.2350
73916764|NCT03167411|147363055|EQUIVALENCE|The ratio of the least squares (LS) geometric means of AUC0-inf when bexagliflozin is dosed in combination with exenatide versus when dosed alone, with 80-125% defined as the lack of interaction boundaries. 90% confidence intervals was constructed.|Point Estimate (%)|137.56|||||TWO_SIDED|90.0|122.28|154.75|||||Estimated ratio (%) of exponentiated mean difference of log-transformed PK parameter from ANOVA (linear mixed-effects model), with treatment, period, and sequence as fixed effects, and subject as a random effect.|||154.75|122.28|
73916765|NCT02984709|147363098|SUPERIORITY||Estimated Mean Difference|-0.17||||0.593|TWO_SIDED|95.0|-0.81|0.47||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||0.47|-0.81|0.593
73916766|NCT02984709|147363099|SUPERIORITY||Estimated Mean Difference|-1.137||||0.581|TWO_SIDED|95.0|-5.27|2.99||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||2.99|-5.27|0.581
73916767|NCT02984709|147363100|SUPERIORITY||Estimated Mean Difference|-0.587||||0.206|TWO_SIDED|95.0|-1.52|0.34||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||0.34|-1.52|0.206
73916768|NCT02984709|147363101|SUPERIORITY||Estimated Mean Difference|-2.494||||0.511|TWO_SIDED|95.0|-10.11|5.13||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Child-reported family conflict||5.13|-10.11|0.511
73916769|NCT02984709|147363101|SUPERIORITY||Estimated Mean Difference|-3.354||||0.19|TWO_SIDED|95.0|-8.44|1.73||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Parent-reported family conflict||1.73|-8.44|0.190
73916770|NCT02984709|147363102|SUPERIORITY||Estimated Mean Difference|0.396||||0.873|TWO_SIDED|95.0|-4.57|5.36||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||5.36|-4.57|0.873
74086268|NCT00442546|147725994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.859||0.742||95.0|-1.806|2.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.399|-1.806|0.7420
73916771|NCT02984709|147363103|SUPERIORITY||Estimated Mean Difference|2.996||||0.603|TWO_SIDED|95.0|-8.57|14.56||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||14.56|-8.57|0.603
73916772|NCT00357968|147363170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.21|||<|0.0001|TWO_SIDED|95.0|38.04|48.38|||ANCOVA|||||48.38|38.04|<0.0001
73916773|NCT00357968|147363171|SUPERIORITY_OR_OTHER||LS Mean difference|14.93|||<|0.0001|TWO_SIDED|95.0|10.6|19.26|||Mixed Models Analysis|||||19.26|10.6|<0.0001
73916774|NCT00357968|147363172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|44.75|||<|0.0001|TWO_SIDED|95.0|38.35|51.15|||ANCOVA|||||51.15|38.35|<0.0001
73916775|NCT00357968|147363177|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
73916776|NCT00357968|147363178|SUPERIORITY_OR_OTHER|||||||0.0629||95.0|||||Fisher Exact|||||||0.0629
73916777|NCT00357968|147363179|SUPERIORITY_OR_OTHER|||||||0.1827||95.0|||||Fisher Exact|||||||0.1827
73916778|NCT00357968|147363180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.3|||<|0.0001|TWO_SIDED|95.0|-61.2|-47.4|||ANCOVA|||||-47.4|-61.2|<0.0001
73916779|NCT00357968|147363181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-60.5|||<|0.0001|TWO_SIDED|95.0|-67.1|-54.0|||ANCOVA|||||-54.0|-67.1|<0.0001
73916780|NCT00357968|147363182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-56.2|||<|0.0001|TWO_SIDED|95.0|-63.2|-49.2|||ANCOVA|||||-49.2|-63.2|<0.0001
73916781|NCT00357968|147363183|SUPERIORITY_OR_OTHER||LS Mean difference|-20.1|||<|0.0001|TWO_SIDED|95.0|-25.7|-14.5|||Mixed Models Analysis|||||-14.5|-25.7|<0.0001
73916782|NCT00357968|147363184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.7058|TWO_SIDED|95.0|-2.95|2.0|||ANCOVA|||||2.00|-2.95|0.7058
73916783|NCT00357968|147363185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.33||||0.4029|TWO_SIDED|95.0|-4.48|1.82|||ANCOVA|||||1.82|-4.48|0.4029
73916784|NCT00357968|147363186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.7893|TWO_SIDED|95.0|-0.06|0.08|||ANCOVA|||||0.08|-0.06|0.7893
74086269|NCT00442546|147725995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.329||0.5299||95.0|-0.458|0.874|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.874|-0.458|0.5299
74086270|NCT00442546|147725995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.355|STANDARD_ERROR_OF_MEAN|0.3||0.2442||95.0|-0.964|0.253|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.253|-0.964|0.2442
73916785|NCT00357968|147363187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.4528|TWO_SIDED|95.0|-0.25|0.07|||ANCOVA|||||0.07|-0.25|0.4528
73966536|NCT05568004|147469419|SUPERIORITY|||||||0.081||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.081
74027601|NCT03114969|147608605|SUPERIORITY||Odds Ratio (OR)|2.391||||0.03|TWO_SIDED|95.0|1.088|5.256||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.256|1.088|0.030
74027602|NCT03114969|147608605|SUPERIORITY||Odds Ratio (OR)|4.728|||<|0.001|TWO_SIDED|95.0|2.388|9.364||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||9.364|2.388|<0.001
74027603|NCT03114969|147608605|SUPERIORITY||Odds Ratio (OR)|2.957||||0.002|TWO_SIDED|95.0|1.473|5.936||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.936|1.473|0.002
73860500|NCT02838901|147266688|OTHER|||||||0.6678|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study and the purpose was to collect preliminary data for a larger trial.||||.6678
73860501|NCT02838901|147266690|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
73860502|NCT02838901|147266690|OTHER|||||||0.876|||||||Wilcoxon (Mann-Whitney)|||||||.876
73860503|NCT02838901|147266691|OTHER|||||||0.889|||||||Wilcoxon (Mann-Whitney)|||||||.889
73860504|NCT02838901|147266691|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||||||0.532
73860505|NCT02838901|147266692|OTHER|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.888
73860506|NCT02838901|147266693|OTHER|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||||||0.475
73860507|NCT02838901|147266694|OTHER|||||||0.135|||||||Wilcoxon (Mann-Whitney)|||||||0.135
73860508|NCT02838901|147266695|OTHER|||||||0.185|||||||Wilcoxon (Mann-Whitney)|||||||0.185
73860509|NCT00623545|147266724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|185.0|STANDARD_DEVIATION|240.0||0.001|TWO_SIDED|95.0||||The a prior threshold for statistical significance was p\< 0.05|ANOVA||units are kcal/d|Previously published literature showed an average weight loss of 1.8 kg at 12 weeks of exenatide treatment. This was converted to differ- ence in TEE, estimating an average imbalance of 2 kg × 7800 kcal·kg-1 divided by 84 days or 185 kcal·day-1.We demonstrated an average reproducibility of the DLW method of 6% or 240 kcal·day-1. For a 5% probability of finding this difference with a power of 80%, we determined a need for 14 subjects to complete the study.||||0.001
73860510|NCT00623545|147266724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73860511|NCT00623545|147266725|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis was that energy intake was unchanged between the period before treatment and at the end of treatment.||||< 0.05
73860512|NCT00623545|147266725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73860513|NCT03220581|147266766|SUPERIORITY||F|9.026||||0.004|TWO_SIDED||||||ANCOVA|Baseline number of days of game play in the past week was included as a covariate.||||||.004
73860514|NCT03220581|147266767|SUPERIORITY||F|7.922||||0.007|TWO_SIDED||||||ANCOVA|Covariate = number of days of gaming in the past week at baseline, reported by the parent.||||||.007
73860515|NCT03220581|147266768|SUPERIORITY||F|3.73||||0.059|TWO_SIDED||||||ANCOVA|Controlled for number of symptoms of Internet gaming disorder at baseline - assessed through clinical interview with child||||||.059
73860516|NCT03220581|147266769|SUPERIORITY||F|2.91||||0.095|TWO_SIDED||||||ANCOVA|Controlled for baseline number of symptoms of Internet gaming disorder, assessed through clinical interview with the parent||||||.095
73860517|NCT00435162|147266778|SUPERIORITY_OR_OTHER||Slope|-1.05||||0.099|TWO_SIDED|95.0|-2.31|0.2|||Regression, Linear|||Slope change across all 3 active treatment groups.||0.20|-2.31|0.0990
73860518|NCT02963987|147266782|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
73860519|NCT02963987|147266783|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
73860520|NCT02963987|147266784|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
73860521|NCT00747344|147266827|SUPERIORITY_OR_OTHER||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs \> 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. With 120 subjects (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight (\<=65kg vs \> 65 kg). For all the scenarios evaluated, the power was \> 99% at a significance level of 0.05.||||<0.001
73860522|NCT00747344|147266828|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs \> 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
73860523|NCT00747344|147266829|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs \> 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
73916786|NCT04600921|147363217|SUPERIORITY|The parameters required to calculate sample size were the expected rate of VT/VF episodes/year in the placebo group, the minimal VT/VF rate ratio to be detected in the ertugliflozin group compared with the placebo group, the average follow-up of treatment duration, the negative binomial dispersion parameter, type 1 error probability, and the desired power.|Rate Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.04|0.61||The yearly rate ratio was adjusted for baseline number of sVT/VF episodes.|Negative binomial regression model|A prespecified sensitivity analysis was done to mitigate the effect of outliers by using the robust estimation approaches for negative binomial model.|Ertugliflozin is the numerator and the placebo is the denominator.|We compared the rate of sVT/VF episodes between experimental arms after 52 weeks.The initial sample calculation was based on the mathematical formula provided by Zhu and Lakkis for comparing event rates of two negative binomial distributiuons. To detect a 30% reduction in VT/VF episode rates in the ertugliflozin group compared to placebo group, with 80% power and an alpha level of 0.05, accounting for 5% drop out in each group, a total sample size of 402 was estimated to be required.||0.61|0.04|<0.001
74086271|NCT00442546|147725995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||2.181|-1.181|0.5226
73916787|NCT04600921|147363218|SUPERIORITY||Rate Ratio|0.34|||||TWO_SIDED|95.0|0.12|0.97||||||The number of incident nsVT episodes were analyzed using a beta binomial model.||0.97|0.12|
73916788|NCT04600921|147363219|SUPERIORITY||Rate Ratio|0.47|||||TWO_SIDED|95.0|0.13|1.81||||||The number of appropriate ICD therapies were analyzed by using beta binomial model.||1.81|0.13|
73916789|NCT04600921|147363220|SUPERIORITY||Difference in mean change|0.17|||>|0.05|TWO_SIDED|95.0|-0.35|0.69|||Regression, Linear|||The change in NTproBNP levels was analyzed by using a multiple linear regression model.||0.69|-0.35|>0.05
73916790|NCT04600921|147363221|SUPERIORITY||Mean Difference (Final Values)|0.72|||||TWO_SIDED|95.0|-1.69|3.13||||||The change in HbA1c levels from baseline to week 52 was analyzed by multiple linear regression model.||3.13|-1.69|
73916791|NCT04600921|147363222|SUPERIORITY||Rate Ratio|0.6|||||TWO_SIDED|95.0|0.2|1.7||||||||1.7|0.2|
73916792|NCT00482612|147363252|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
73916793|NCT00482612|147363252|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
73916794|NCT00482612|147363252|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
73916795|NCT00482612|147363253|SUPERIORITY_OR_OTHER|||||||0.0014|||||||ANCOVA|Baseline SL was used as a covariate.||||||0.0014
73916796|NCT00482612|147363253|SUPERIORITY_OR_OTHER|||||||0.0135|||||||ANCOVA|Baseline SL was used as a covariate.||||||0.0135
73916797|NCT00482612|147363253|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline SL was used as a covariate.||||||<0.0001
73916798|NCT00759031|147363273|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73916799|NCT02899988|147363292|SUPERIORITY||Risk Difference (RD)|29.4||||0.009|TWO_SIDED|95.0|16.9|41.9|||Regression, Logistic|||||41.9|16.9|0.009
73916800|NCT02899988|147363292|SUPERIORITY||Risk Difference (RD)|58.8|||<|0.001|TWO_SIDED|95.0|45.3|72.3|||Regression, Logistic|||||72.3|45.3|<0.001
74086272|NCT00442546|147725995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.823|-2.156|0.8557
73916801|NCT02899988|147363292|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|53.7|79.6|||Regression, Logistic|||||79.6|53.7|<0.001
73916802|NCT02899988|147363293|SUPERIORITY||Risk Difference (RD)|15.7||||0.039|TWO_SIDED|95.0|5.7|25.7|||Regression, Logistic|||||25.7|5.7|0.039
73916803|NCT02899988|147363293|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||||44.1|18.6|0.007
74086273|NCT00442546|147725995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.119|STANDARD_ERROR_OF_MEAN|1.024||0.324||95.0|-3.751|1.512|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.512|-3.751|0.3240
73916804|NCT02899988|147363293|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||||44.1|18.6|0.007
73916805|NCT02899988|147363294|SUPERIORITY||Risk Difference (RD)|22.49|||<|0.001|TWO_SIDED|95.0|5.62|89.97|||Regression, Logistic|||||89.97|5.62|<0.001
73916806|NCT02899988|147363294|SUPERIORITY||Risk Difference (RD)|74.6|||<|0.001|TWO_SIDED|95.0|62.1|87.0|||Regression, Logistic|||||87.0|62.1|<0.001
73916807|NCT02899988|147363294|SUPERIORITY||Risk Difference (RD)|70.7|||<|0.001|TWO_SIDED|95.0|57.6|83.7|||Regression, Logistic|||||83.7|57.6|<0.001
73916808|NCT02899988|147363295|SUPERIORITY||Risk Difference (RD)|15.7||||0.041|TWO_SIDED|95.0|5.7|25.7|||Regression, Logistic|||sPGA (0)||25.7|5.7|0.041
73916809|NCT02899988|147363295|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||sPGA (0)||44.1|18.6|0.007
73916810|NCT02899988|147363295|SUPERIORITY||Risk Difference (RD)|31.4||||0.008|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||sPGA (0)||44.1|18.6|0.008
73916811|NCT02899988|147363295|SUPERIORITY||Risk Difference (RD)|35.3|||<|0.001|TWO_SIDED|95.0|21.5|49.1|||Regression, Logistic|||sPGA (0/1)||49.1|21.5|<0.001
73916812|NCT02899988|147363295|SUPERIORITY||Risk Difference (RD)|68.7|||<|0.001|TWO_SIDED|95.0|55.6|81.7|||Regression, Logistic|||sPGA (0/1)||81.7|55.6|<0.001
73916813|NCT02899988|147363295|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|53.4|80.0|||Regression, Logistic|||sPGA (0/1)||80.0|53.4|<0.001
73916814|NCT02899988|147363296|SUPERIORITY||Mean Difference (Net)|-26.84|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73916815|NCT02899988|147363296|SUPERIORITY||Mean Difference (Net)|-37.99|STANDARD_ERROR_OF_MEAN|3.29|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73916816|NCT02899988|147363296|SUPERIORITY||Mean Difference (Net)|-29.32|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73916817|NCT02899988|147363297|SUPERIORITY||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74086274|NCT00442546|147725995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|1.139||0.9503||95.0|-2.853|3.003|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||3.003|-2.853|0.9503
74027604|NCT03114969|147608606|SUPERIORITY||Odds Ratio (OR)|2.404||||0.045|TWO_SIDED|95.0|1.018|5.676||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||5.676|1.018|0.045
74027605|NCT03114969|147608606|SUPERIORITY||Odds Ratio (OR)|1.823||||0.172|TWO_SIDED|95.0|0.77|4.319||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.319|0.770|0.172
74027606|NCT03114969|147608606|SUPERIORITY||Odds Ratio (OR)|2.989||||0.016|TWO_SIDED|95.0|1.229|7.272||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||7.272|1.229|0.016
74086275|NCT00442546|147725995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.833|STANDARD_ERROR_OF_MEAN|1.858||0.3618||95.0|-6.379|2.712|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.712|-6.379|0.3618
74086276|NCT00442546|147725995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.896||0.7226||95.0|-1.859|2.525|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.525|-1.859|0.7226
74086277|NCT00442546|147725996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2473||95.0|||||Cochran-Mantel-Haenszel|||Discharge||||0.2473
74086278|NCT00442546|147725996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0239||95.0|||||Cochran-Mantel-Haenszel|||Discharge||||0.0239
74086279|NCT00442546|147725996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6118||95.0|||||Cochran-Mantel-Haenszel|||Week 2||||0.6118
74086280|NCT00442546|147725996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673||95.0|||||Cochran-Mantel-Haenszel|||Week 2||||0.6730
73916818|NCT02899988|147363297|SUPERIORITY||Mean Difference (Net)|2.56|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73916819|NCT02899988|147363297|SUPERIORITY||Mean Difference (Net)|2.47|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73916820|NCT02899988|147363298|SUPERIORITY||Mean Difference (Net)|-8.12|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73916821|NCT02899988|147363298|SUPERIORITY||Mean Difference (Net)|-9.11|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73916822|NCT02899988|147363298|SUPERIORITY||Mean Difference (Net)|-8.57|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73916823|NCT02899988|147363299|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|1.24||0.009|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.009
73916824|NCT02899988|147363299|SUPERIORITY||Mean Difference (Net)|2.74|STANDARD_ERROR_OF_MEAN|1.22||0.002|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.002
73916825|NCT02899988|147363299|SUPERIORITY||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.24||0.087|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.087
73916826|NCT02899988|147363299|SUPERIORITY||Mean Difference (Net)|3.35|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
73916827|NCT02899988|147363299|SUPERIORITY||Mean Difference (Net)|3.16|STANDARD_ERROR_OF_MEAN|1.18|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
73916828|NCT02899988|147363299|SUPERIORITY||Mean Difference (Net)|3.86|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
73916829|NCT03975790|147363314|SUPERIORITY|||||||0.4695|||||||Chi-squared|||||||0.4695
73916830|NCT03975790|147363314|SUPERIORITY|||||||0.7644|||||||Chi-squared|||||||0.7644
74027607|NCT03114969|147608606|SUPERIORITY||Odds Ratio (OR)|1.747||||0.179|TWO_SIDED|95.0|0.775|3.937||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||3.937|0.775|0.179
74086281|NCT00442546|147725996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5954||95.0|||||Cochran-Mantel-Haenszel|||Week 4||||0.5954
74086282|NCT00442546|147725996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7784||95.0|||||Cochran-Mantel-Haenszel|||Week 4||||0.7784
74086283|NCT00442546|147725996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7293||95.0|||||Cochran-Mantel-Haenszel|||Week 6/ET||||0.7293
74086284|NCT00442546|147725996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5202||95.0|||||Cochran-Mantel-Haenszel|||Week 6/ET||||0.5202
74086285|NCT00442546|147725997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1509||95.0|||||Cochran-Mantel-Haenszel|||Month 3||||0.1509
74086286|NCT00442546|147725997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3822||95.0|||||Cochran-Mantel-Haenszel|||Month 3||||0.3822
74086287|NCT00442546|147725997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2825||95.0|||||Cochran-Mantel-Haenszel|||Month 6||||0.2825
74086288|NCT00442546|147725997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7733||95.0|||||Cochran-Mantel-Haenszel|||Month 6||||0.7733
74086289|NCT01557582|147725999|SUPERIORITY_OR_OTHER||EDV percent difference|4.8|||||TWO_SIDED|95.0|2.24|7.56|||||Mean percent difference and 95% CI for EDV|||7.56|2.24|
74086290|NCT01557582|147725999|SUPERIORITY_OR_OTHER||ESV percent difference|1.76|||||TWO_SIDED|95.0|-1.17|4.76|||||Mean percent difference and 95% CI for ESV|||4.76|-1.17|
74086291|NCT01557582|147725999|SUPERIORITY_OR_OTHER||EF percent difference|2.03|||||TWO_SIDED|95.0|0.72|3.33|||||Mean percent difference and 95% CI for EF|||3.33|0.72|
74086292|NCT02413294|147726032|SUPERIORITY|||||||0.37||||||This t-test analyzes the change in mean between the midpoint interview immediately prior to the start of the intervention and the follow-up interview at the conclusion of the intervention.|Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.37
74086293|NCT02413294|147726033|SUPERIORITY|||||||0.42|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.42
74088402|NCT00107042|147730238|SUPERIORITY_OR_OTHER||Mean response|2.29|||||TWO_SIDED|95.0|2.05|2.53|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."||2.53|2.05|
74086294|NCT02413294|147726034|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.65
74086295|NCT02413294|147726035|SUPERIORITY|||||||1|||||||Fisher Exact|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||1.0
73860524|NCT00765882|147266830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93||||0.0012|TWO_SIDED|95.0|1.5|5.72||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 90% based on study NCT00402337 (MCP-103-201) data."||5.72|1.50|0.0012
73860525|NCT00765882|147266830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.22|||<|0.0001|TWO_SIDED|95.0|2.2|8.1||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 96% based on study NCT00460811 (MCP-103-202) data."||8.10|2.20|<0.0001
73860526|NCT01853072|147266911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.5|3.0|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.||3.0|1.5|<0.001
73860527|NCT01853072|147266912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.1|0.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.||0.3|0.1|<0.001
73860528|NCT01527383|147266942|OTHER||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||<0.0001
73860529|NCT01527383|147266943|OTHER||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||<0.0001
73860530|NCT01287221|147266967|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.82
73860531|NCT01287221|147266968|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.62
73860532|NCT01287221|147266969|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.23
73860533|NCT01287221|147266970|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.31
73860534|NCT01287221|147266971|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.65
73860535|NCT01287221|147266972|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.61
73860536|NCT01287221|147266973|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.22
73916831|NCT03975790|147363314|SUPERIORITY|||||||0.8316|||||||Chi-squared|||||||0.8316
73860537|NCT01294462|147267001|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.94|2.53||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison.||2.53|0.94|
73860538|NCT01294462|147267002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.88|2.44||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.||2.44|0.88|
73916832|NCT03975790|147363315|SUPERIORITY|||||||0.9829|||||||Chi-squared|||||||0.9829
73916833|NCT03975790|147363315|SUPERIORITY|||||||0.8021|||||||Chi-squared|||||||0.8021
73916834|NCT03975790|147363315|SUPERIORITY|||||||0.8376|||||||Chi-squared|||||||0.8376
73916835|NCT03975790|147363316|SUPERIORITY|||||||0.2864|||||||t-test|||||||0.2864
73916836|NCT03975790|147363316|SUPERIORITY|||||||0.1583|||||||t-test|||||||0.1583
73916837|NCT03975790|147363316|SUPERIORITY|||||||0.4546|||||||t-test|||||||0.4546
74086296|NCT02413294|147726036|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.65
74086297|NCT02413294|147726037|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.65
73916838|NCT03975790|147363317|SUPERIORITY|||||||0.028|||||||t-test|||||||0.0280
73916839|NCT03975790|147363317|SUPERIORITY|||||||0.0106|||||||t-test|||||||0.0106
73916840|NCT03975790|147363317|SUPERIORITY|||||||0.7293|||||||t-test|||||||0.7293
73916841|NCT03975790|147363318|SUPERIORITY|||||||0.9215|||||||Chi-squared|||||||0.9215
73916842|NCT03975790|147363318|SUPERIORITY|||||||0.6078|||||||Chi-squared|||||||0.6078
73916843|NCT03975790|147363318|SUPERIORITY|||||||0.6258|||||||Chi-squared|||||||0.6258
73916844|NCT03975790|147363319|SUPERIORITY|||||||0.3586|||||||Chi-squared|||||||0.3586
73916845|NCT03975790|147363319|SUPERIORITY|||||||0.5117|||||||Chi-squared|||||||0.5117
73966537|NCT05568004|147469420|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||<0.001
73966538|NCT05568004|147469420|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||<0.001
73966539|NCT05568004|147469420|SUPERIORITY|||||||0.747||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.747
73966540|NCT05568004|147469421|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.001
73966541|NCT05568004|147469421|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||<0.001
73966542|NCT05568004|147469421|SUPERIORITY|||||||0.05||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.05
73966543|NCT05873751|147469492|OTHER||Calibrated VE|2.74|||||TWO_SIDED|95.0|-10.35|15.59|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||15.59|-10.35|
73916846|NCT03975790|147363320|SUPERIORITY|||||||0.5372|||||||t-test|||||||0.5372
73916847|NCT03975790|147363320|SUPERIORITY|||||||0.6155|||||||t-test|||||||0.6155
73916848|NCT03975790|147363320|SUPERIORITY|||||||0.9696|||||||t-test|||||||0.9696
73916849|NCT03975790|147363321|SUPERIORITY|||||||0.2514|||||||t-test|||||||0.2514
73916850|NCT03975790|147363321|SUPERIORITY|||||||0.9851|||||||t-test|||||||0.9851
73916851|NCT03975790|147363321|SUPERIORITY|||||||0.4309|||||||t-test|||||||0.4309
73916852|NCT03975790|147363322|SUPERIORITY|||||||0.6033|||||||t-test|||||||0.6033
73916853|NCT03975790|147363322|SUPERIORITY|||||||0.348|||||||t-test|||||||0.3480
73916854|NCT03975790|147363322|SUPERIORITY|||||||0.5375|||||||t-test|||||||0.5375
73916855|NCT03975790|147363323|SUPERIORITY|||||||0.0345|||||||Chi-squared|||Other aftercare||||0.0345
73916856|NCT03975790|147363323|SUPERIORITY|||||||0.2316|||||||Chi-squared|||Other aftercare||||0.2316
73916857|NCT03975790|147363323|SUPERIORITY|||||||0.7349|||||||Chi-squared|||Other aftercare||||0.7349
73916858|NCT03975790|147363323|SUPERIORITY|||||||0.0774|||||||Chi-squared|||Other connective tissue disease||||0.0774
73916859|NCT03975790|147363323|SUPERIORITY|||||||0.4228|||||||Chi-squared|||Other connective tissue disease||||0.4228
73916860|NCT03975790|147363323|SUPERIORITY|||||||0.0583|||||||Chi-squared|||Other connective tissue disease||||0.0583
73916861|NCT03975790|147363323|SUPERIORITY|||||||0.9683|||||||Chi-squared|||Other non-traumatic joint disorders||||0.9683
73916862|NCT03975790|147363323|SUPERIORITY|||||||0.8877|||||||Chi-squared|||Other non-traumatic joint disorders||||0.8877
73916863|NCT03975790|147363323|SUPERIORITY|||||||0.9228|||||||Chi-squared|||Other non-traumatic joint disorders||||0.9228
73916864|NCT03975790|147363323|SUPERIORITY|||||||0.7661|||||||Chi-squared|||Medical examination/evaluation||||0.7661
73916865|NCT03975790|147363323|SUPERIORITY|||||||0.3034|||||||Chi-squared|||Medical examination/evaluation||||0.3034
73916866|NCT03975790|147363323|SUPERIORITY|||||||0.2765|||||||Chi-squared|||Medical examination/evaluation||||0.2765
73916867|NCT03975790|147363323|SUPERIORITY|||||||0.8652|||||||Chi-squared|||Other suspected conditions||||0.8652
73916868|NCT03975790|147363323|SUPERIORITY|||||||0.2243|||||||Chi-squared|||Other suspected conditions||||0.2243
73916869|NCT03975790|147363323|SUPERIORITY|||||||0.3449|||||||Chi-squared|||Other suspected conditions||||0.3449
73916870|NCT03975790|147363323|SUPERIORITY|||||||0.3529|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.3529
73916871|NCT03975790|147363323|SUPERIORITY|||||||0.1012|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.1012
73916872|NCT03975790|147363323|SUPERIORITY|||||||0.4123|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.4123
73916873|NCT03975790|147363323|SUPERIORITY|||||||0.2742|||||||Chi-squared|||Osteoarthritis||||0.2742
73916874|NCT03975790|147363323|SUPERIORITY|||||||0.1009|||||||Chi-squared|||Osteoarthritis||||0.1009
73916875|NCT03975790|147363323|SUPERIORITY|||||||0.0318|||||||Chi-squared|||Osteoarthritis||||0.0318
73916876|NCT03975790|147363323|SUPERIORITY|||||||0.4808|||||||Chi-squared|||Essential hypertension||||0.4808
73916877|NCT03975790|147363323|SUPERIORITY|||||||0.0778|||||||Chi-squared|||Essential hypertension||||0.0778
73916878|NCT03975790|147363323|SUPERIORITY|||||||0.2871|||||||Chi-squared|||Essential hypertension||||0.2871
73916879|NCT03975790|147363323|SUPERIORITY|||||||0.7356|||||||Chi-squared|||Residual codes; unclassified||||0.7356
73916880|NCT03975790|147363323|SUPERIORITY|||||||0.4975|||||||Chi-squared|||Residual codes; unclassified||||0.4975
73916881|NCT03975790|147363323|SUPERIORITY|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified||||0.7143
73916882|NCT03975790|147363323|SUPERIORITY|||||||0.3559|||||||Chi-squared|||Disorders of lipid metabolism||||0.3559
73916883|NCT03975790|147363323|SUPERIORITY|||||||0.7725|||||||Chi-squared|||Disorders of lipid metabolism||||0.7725
73916884|NCT03975790|147363323|SUPERIORITY|||||||0.3875|||||||Chi-squared|||Disorders of lipid metabolism||||0.3875
73916885|NCT03975790|147363323|SUPERIORITY|||||||0.0225|||||||Chi-squared|||Back problems||||0.0225
73916886|NCT03975790|147363323|SUPERIORITY|||||||0.4427|||||||Chi-squared|||Back problems||||0.4427
73916887|NCT03975790|147363323|SUPERIORITY|||||||0.4094|||||||Chi-squared|||Back problems||||0.4094
73916888|NCT03975790|147363323|SUPERIORITY|||||||0.8775|||||||Chi-squared|||Other upper respiratory infections||||0.8775
73916889|NCT03975790|147363323|SUPERIORITY|||||||0.3525|||||||Chi-squared|||Other upper respiratory infections||||0.3525
73916890|NCT03975790|147363323|SUPERIORITY|||||||0.4724|||||||Chi-squared|||Other upper respiratory infections||||0.4724
73916891|NCT03975790|147363323|SUPERIORITY|||||||0.717|||||||Chi-squared|||Other lower respiratory disease||||0.7170
73916892|NCT03975790|147363323|SUPERIORITY|||||||0.2909|||||||Chi-squared|||Other lower respiratory disease||||0.2909
73916893|NCT03975790|147363323|SUPERIORITY|||||||0.5057|||||||Chi-squared|||Other lower respiratory disease||||0.5057
73916894|NCT03975790|147363323|SUPERIORITY|||||||0.2613|||||||Chi-squared|||Other nervous system disorders||||0.2613
73916895|NCT03975790|147363323|SUPERIORITY|||||||0.9901|||||||Chi-squared|||Other nervous system disorders||||0.9901
73916896|NCT03975790|147363323|SUPERIORITY|||||||0.4768|||||||Chi-squared|||Other nervous system disorders||||0.4768
73916897|NCT03975790|147363323|SUPERIORITY|||||||0.0219|||||||Chi-squared|||Other skin disorders||||0.0219
73916898|NCT03975790|147363323|SUPERIORITY|||||||0.5172|||||||Chi-squared|||Other skin disorders||||0.5172
73916899|NCT03975790|147363323|SUPERIORITY|||||||0.0278|||||||Chi-squared|||Other skin disorders||||0.0278
73916900|NCT03975790|147363323|SUPERIORITY|||||||0.6103|||||||Chi-squared|||Thyroid disorders||||0.6103
73916901|NCT03975790|147363323|SUPERIORITY|||||||0.1682|||||||Chi-squared|||Thyroid disorders||||0.1682
73916902|NCT03975790|147363323|SUPERIORITY|||||||0.3654|||||||Chi-squared|||Thyroid disorders||||0.3654
73916903|NCT03975790|147363323|SUPERIORITY|||||||0.7637|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.7637
73916904|NCT03975790|147363323|SUPERIORITY|||||||0.8693|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.8693
73916905|NCT03975790|147363323|SUPERIORITY|||||||0.7349|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.7349
73916906|NCT03975790|147363323|SUPERIORITY|||||||0.7324|||||||Chi-squared|||Malaise/fatigue||||0.7324
73916907|NCT03975790|147363323|SUPERIORITY|||||||0.4182|||||||Chi-squared|||Malaise/fatigue||||0.4182
73916908|NCT03975790|147363323|SUPERIORITY|||||||0.62|||||||Chi-squared|||Malaise/fatigue||||0.6200
73916909|NCT03975790|147363323|SUPERIORITY|||||||0.6064|||||||Chi-squared|||Esophageal disorders||||0.6064
73916910|NCT03975790|147363323|SUPERIORITY|||||||0.636|||||||Chi-squared|||Esophageal disorders||||0.6360
73916911|NCT03975790|147363323|SUPERIORITY|||||||0.9445|||||||Chi-squared|||Esophageal disorders||||0.9445
73916912|NCT03975790|147363323|SUPERIORITY|||||||0.8135|||||||Chi-squared|||Nutritional deficiencies||||0.8135
73916913|NCT03975790|147363323|SUPERIORITY|||||||0.6705|||||||Chi-squared|||Nutritional deficiencies||||0.6705
73916914|NCT03975790|147363323|SUPERIORITY|||||||0.8331|||||||Chi-squared|||Nutritional deficiencies||||0.8331
73916915|NCT03975790|147363323|SUPERIORITY|||||||0.4158|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.4158
73916916|NCT03975790|147363323|SUPERIORITY|||||||0.636|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.6360
73916917|NCT03975790|147363323|SUPERIORITY|||||||0.3336|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.3336
73916918|NCT03975790|147363323|SUPERIORITY|||||||0.6402|||||||Chi-squared|||Diabetes mellitus without complication||||0.6402
73916919|NCT03975790|147363323|SUPERIORITY|||||||0.8068|||||||Chi-squared|||Diabetes mellitus without complication||||0.8068
73916920|NCT03975790|147363323|SUPERIORITY|||||||0.5983|||||||Chi-squared|||Diabetes mellitus without complication||||0.5983
73916921|NCT03975790|147363323|SUPERIORITY|||||||0.9759|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.9759
73916922|NCT03975790|147363323|SUPERIORITY|||||||0.136|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.1360
73916923|NCT03975790|147363323|SUPERIORITY|||||||0.1815|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.1815
73916924|NCT03975790|147363323|SUPERIORITY|||||||0.2731|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.2731
73916925|NCT03975790|147363323|SUPERIORITY|||||||0.8327|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.8327
73916926|NCT03975790|147363323|SUPERIORITY|||||||0.342|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.3420
73916927|NCT03975790|147363324|SUPERIORITY|||||||0.059|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.0590
73916928|NCT03975790|147363324|SUPERIORITY|||||||0.7055|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.7055
73916929|NCT03975790|147363324|SUPERIORITY|||||||0.3088|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.3088
73916930|NCT03975790|147363324|SUPERIORITY|||||||0.0036|||||||Chi-squared|||Other aftercare||||0.0036
73916931|NCT03975790|147363324|SUPERIORITY|||||||0.3772|||||||Chi-squared|||Other aftercare||||0.3772
73916932|NCT03975790|147363324|SUPERIORITY|||||||0.3|||||||Chi-squared|||Other aftercare||||0.3000
73916933|NCT03975790|147363324|SUPERIORITY|||||||0.7354|||||||Chi-squared|||Other connective tissue disease||||0.7354
73916934|NCT03975790|147363324|SUPERIORITY|||||||0.1435|||||||Chi-squared|||Other connective tissue disease||||0.1435
73916935|NCT03975790|147363324|SUPERIORITY|||||||0.2876|||||||Chi-squared|||Other connective tissue disease||||0.2876
73916936|NCT03975790|147363324|SUPERIORITY|||||||0.2848|||||||Chi-squared|||Other non-traumatic joint disorders||||0.2848
73916937|NCT03975790|147363324|SUPERIORITY|||||||0.183|||||||Chi-squared|||Other non-traumatic joint disorders||||0.1830
73916938|NCT03975790|147363324|SUPERIORITY|||||||0.6453|||||||Chi-squared|||Other non-traumatic joint disorders||||0.6453
73916939|NCT03975790|147363324|SUPERIORITY|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation||||0.8717
73916940|NCT03975790|147363324|SUPERIORITY|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation||||0.8717
73916941|NCT03975790|147363324|SUPERIORITY|||||||0.3422|||||||Chi-squared|||Medical examination/evaluation||||0.3422
74027608|NCT03114969|147608606|SUPERIORITY||Odds Ratio (OR)|1.189||||0.69|TWO_SIDED|95.0|0.509|2.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||2.775|0.509|0.690
74027609|NCT03114969|147608606|SUPERIORITY||Odds Ratio (OR)|3.363||||0.004|TWO_SIDED|95.0|1.48|7.639||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.639|1.480|0.004
74027610|NCT03114969|147608606|SUPERIORITY||Odds Ratio (OR)|2.848||||0.012|TWO_SIDED|95.0|1.264|6.42||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||6.420|1.264|0.012
74027611|NCT03114969|147608606|SUPERIORITY||Odds Ratio (OR)|4.63|||<|0.001|TWO_SIDED|95.0|1.986|10.791||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||10.791|1.986|<0.001
74027612|NCT03114969|147608606|SUPERIORITY||Odds Ratio (OR)|2.037||||0.081|TWO_SIDED|95.0|0.916|4.528||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||4.528|0.916|0.081
74027613|NCT03114969|147608606|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.438|2.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||2.283|0.438|1.000
74027614|NCT03114969|147608607|SUPERIORITY||Odds Ratio (OR)|1.935||||0.067|TWO_SIDED|95.0|0.955|3.921||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||3.921|0.955|0.067
74027615|NCT03114969|147608607|SUPERIORITY||Odds Ratio (OR)|2.523||||0.007|TWO_SIDED|95.0|1.283|4.961||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.961|1.283|0.007
74086298|NCT02413294|147726038|SUPERIORITY|||||||0.94|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.94
74086299|NCT02413294|147726039|SUPERIORITY|||||||0.81|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.81
73916942|NCT03975790|147363324|SUPERIORITY|||||||0.3465|||||||Chi-squared|||Other suspected conditions||||0.3465
73916943|NCT03975790|147363324|SUPERIORITY|||||||0.4953|||||||Chi-squared|||Other suspected conditions||||0.4953
73916944|NCT03975790|147363324|SUPERIORITY|||||||0.9796|||||||Chi-squared|||Other suspected conditions||||0.9796
73916945|NCT03975790|147363324|SUPERIORITY|||||||0.4187|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.4187
73916946|NCT03975790|147363324|SUPERIORITY|||||||0.151|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.1510
73916947|NCT03975790|147363324|SUPERIORITY|||||||0.0751|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.0751
73916948|NCT03975790|147363324|SUPERIORITY|||||||0.7577|||||||Chi-squared|||Osteoarthritis||||0.7577
73916949|NCT03975790|147363324|SUPERIORITY|||||||0.802|||||||Chi-squared|||Osteoarthritis||||0.8020
74027616|NCT03114969|147608608|SUPERIORITY||Odds Ratio (OR)|2.399||||0.008|TWO_SIDED|95.0|1.252|4.596||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||4.596|1.252|0.008
74027617|NCT03114969|147608608|SUPERIORITY||Odds Ratio (OR)|1.812||||0.082|TWO_SIDED|95.0|0.926|3.544||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||3.544|0.926|0.082
74027618|NCT03114969|147608608|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.135|6.905||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||6.905|2.135|<0.001
74027619|NCT03114969|147608608|SUPERIORITY||Odds Ratio (OR)|3.231|||<|0.001|TWO_SIDED|95.0|1.81|5.766||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.766|1.810|<0.001
74086300|NCT02413294|147726040|SUPERIORITY|||||||0.4|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.40
74086301|NCT02413294|147726041|SUPERIORITY|||||||0.46|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.46
73916950|NCT03975790|147363324|SUPERIORITY|||||||0.9879|||||||Chi-squared|||Osteoarthritis||||0.9879
73916951|NCT03975790|147363324|SUPERIORITY|||||||0.1717|||||||Chi-squared|||Essential hypertension||||0.1717
73916952|NCT03975790|147363324|SUPERIORITY|||||||0.3065|||||||Chi-squared|||Essential hypertension||||0.3065
73916953|NCT03975790|147363324|SUPERIORITY|||||||0.992|||||||Chi-squared|||Essential hypertension||||0.9920
73916954|NCT03975790|147363324|SUPERIORITY|||||||0.4626|||||||Chi-squared|||Residual codes; unclassified||||0.4626
73916955|NCT03975790|147363324|SUPERIORITY|||||||0.8922|||||||Chi-squared|||Residual codes; unclassified||||0.8922
73916956|NCT03975790|147363324|SUPERIORITY|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified||||0.7143
73916957|NCT03975790|147363324|SUPERIORITY|||||||0.8212|||||||Chi-squared|||Disorders of lipid metabolism||||0.8212
73916958|NCT03975790|147363324|SUPERIORITY|||||||0.5732|||||||Chi-squared|||Disorders of lipid metabolism||||0.5732
73916959|NCT03975790|147363324|SUPERIORITY|||||||0.7319|||||||Chi-squared|||Disorders of lipid metabolism||||0.7319
74086302|NCT02413294|147726042|SUPERIORITY||||||<|0.01|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||<0.01
73916960|NCT03975790|147363324|SUPERIORITY|||||||0.9272|||||||Chi-squared|||Back problems||||0.9272
73916961|NCT03975790|147363324|SUPERIORITY|||||||0.1441|||||||Chi-squared|||Back problems||||0.1441
73916962|NCT03975790|147363324|SUPERIORITY|||||||0.1859|||||||Chi-squared|||Back problems||||0.1859
73916963|NCT03975790|147363324|SUPERIORITY|||||||0.3109|||||||Chi-squared|||Other upper respiratory infections||||0.3109
73916964|NCT03975790|147363324|SUPERIORITY|||||||0.3313|||||||Chi-squared|||Other upper respiratory infections||||0.3313
73916965|NCT03975790|147363324|SUPERIORITY|||||||0.1279|||||||Chi-squared|||Other upper respiratory infections||||0.1279
73916966|NCT03975790|147363324|SUPERIORITY|||||||0.7575|||||||Chi-squared|||Other lower respiratory disease||||0.7575
73916967|NCT03975790|147363324|SUPERIORITY|||||||0.1583|||||||Chi-squared|||Other lower respiratory disease||||0.1583
73916968|NCT03975790|147363324|SUPERIORITY|||||||0.1569|||||||Chi-squared|||Other lower respiratory disease||||0.1569
73916969|NCT03975790|147363324|SUPERIORITY|||||||0.0745|||||||Chi-squared|||Other nervous system disorders||||0.0745
74086303|NCT02413294|147726043|SUPERIORITY|||||||0.28|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.28
74086304|NCT02413294|147726044|SUPERIORITY|||||||0.67|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.67
73916970|NCT03975790|147363324|SUPERIORITY|||||||0.0933|||||||Chi-squared|||Other nervous system disorders||||0.0933
73916971|NCT03975790|147363324|SUPERIORITY|||||||0.791|||||||Chi-squared|||Other nervous system disorders||||0.7910
73916972|NCT03975790|147363324|SUPERIORITY|||||||0.6755|||||||Chi-squared|||Other skin disorders||||0.6755
73916973|NCT03975790|147363324|SUPERIORITY|||||||0.4183|||||||Chi-squared|||Other skin disorders||||0.4183
73916974|NCT03975790|147363324|SUPERIORITY|||||||0.6749|||||||Chi-squared|||Other skin disorders||||0.6749
73916975|NCT03975790|147363324|SUPERIORITY|||||||0.6626|||||||Chi-squared|||Thyroid disorders||||0.6626
73916976|NCT03975790|147363324|SUPERIORITY|||||||0.5766|||||||Chi-squared|||Thyroid disorders||||0.5766
73916977|NCT03975790|147363324|SUPERIORITY|||||||0.8376|||||||Chi-squared|||Thyroid disorders||||0.8376
73916978|NCT03975790|147363324|SUPERIORITY|||||||0.2857|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.2857
73916979|NCT03975790|147363324|SUPERIORITY|||||||0.956|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.9560
73916980|NCT03975790|147363324|SUPERIORITY|||||||0.4384|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.4384
73916981|NCT03975790|147363324|SUPERIORITY|||||||0.6082|||||||Chi-squared|||Malaise/fatigue||||0.6082
73916982|NCT03975790|147363324|SUPERIORITY|||||||0.3374|||||||Chi-squared|||Malaise/fatigue||||0.3374
73916983|NCT03975790|147363324|SUPERIORITY|||||||0.5984|||||||Chi-squared|||Malaise/fatigue||||0.5984
73916984|NCT03975790|147363324|SUPERIORITY|||||||0.8568|||||||Chi-squared|||Esophageal disorders||||0.8568
73916985|NCT03975790|147363324|SUPERIORITY|||||||0.7698|||||||Chi-squared|||Esophageal disorders||||0.7698
73916986|NCT03975790|147363324|SUPERIORITY|||||||0.7089|||||||Chi-squared|||Esophageal disorders||||0.7089
73916987|NCT03975790|147363324|SUPERIORITY|||||||0.3446|||||||Chi-squared|||Nutritional deficiencies||||0.3446
73916988|NCT03975790|147363324|SUPERIORITY|||||||0.0815|||||||Chi-squared|||Nutritional deficiencies||||0.0815
73916989|NCT03975790|147363324|SUPERIORITY|||||||0.402|||||||Chi-squared|||Nutritional deficiencies||||0.4020
73916990|NCT03975790|147363324|SUPERIORITY|||||||0.4246|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.4246
73916991|NCT03975790|147363324|SUPERIORITY|||||||0.8118|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.8118
73916992|NCT03975790|147363324|SUPERIORITY|||||||0.7454|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.7454
73916993|NCT03975790|147363324|SUPERIORITY|||||||0.3559|||||||Chi-squared|||Diabetes mellitus without complication||||0.3559
73916994|NCT03975790|147363324|SUPERIORITY|||||||0.7698|||||||Chi-squared|||Diabetes mellitus without complication||||0.7698
73916995|NCT03975790|147363324|SUPERIORITY|||||||0.7323|||||||Chi-squared|||Diabetes mellitus without complication||||0.7323
73916996|NCT03975790|147363324|SUPERIORITY|||||||0.5935|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.5935
73916997|NCT03975790|147363324|SUPERIORITY|||||||0.3928|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.3928
73916998|NCT03975790|147363324|SUPERIORITY|||||||0.7089|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.7089
73916999|NCT03975790|147363324|SUPERIORITY|||||||0.8746|||||||Chi-squared|||Other upper respiratory disease||||0.8746
73917000|NCT03975790|147363324|SUPERIORITY|||||||0.3835|||||||Chi-squared|||Other upper respiratory disease||||0.3835
73917001|NCT03975790|147363324|SUPERIORITY|||||||0.4992|||||||Chi-squared|||Other upper respiratory disease||||0.4992
73917002|NCT03975790|147363325|SUPERIORITY|||||||0.2336|||||||t-test|||||||0.2336
73917003|NCT03975790|147363325|SUPERIORITY|||||||0.2109|||||||t-test|||||||0.2109
73917004|NCT03975790|147363325|SUPERIORITY|||||||0.0691|||||||t-test|||||||0.0691
73917005|NCT03975790|147363326|SUPERIORITY|||||||0.9758|||||||Chi-squared|||MTX Sodium||||0.9758
73917006|NCT03975790|147363326|SUPERIORITY|||||||0.9978|||||||Chi-squared|||MTX Sodium||||0.9978
73917007|NCT03975790|147363326|SUPERIORITY|||||||0.9861|||||||Chi-squared|||MTX Sodium||||0.9861
73917008|NCT03975790|147363326|SUPERIORITY|||||||0.5744|||||||Chi-squared|||Folic Acid||||0.5744
73966544|NCT05873751|147469493|OTHER||Calibrated VE|-2.2|||||TWO_SIDED|95.0|-23.5|13.85|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||13.85|-23.50|
73966545|NCT05873751|147469494|OTHER||Calibrated VE|2.74|||||TWO_SIDED|95.0|-10.35|15.59|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||15.59|-10.35|
73966546|NCT05873751|147469495|OTHER||Calibrated VE|-2.2|||||TWO_SIDED|95.0|-23.5|13.85|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||13.85|-23.50|
74086305|NCT02413294|147726045|SUPERIORITY|||||||0.56|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.56
74086306|NCT02413294|147726046|SUPERIORITY|||||||0.82|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.82
73917009|NCT03975790|147363326|SUPERIORITY|||||||0.8542|||||||Chi-squared|||Folic Acid||||0.8542
73966547|NCT00274469|147469504|NON_INFERIORITY|Study is powered basing on 20% deficiency in benefit rate for Fulvestrant compared to Anastrozole.|Odds Ratio (OR)|1.302||||0.386|TWO_SIDED|95.0|0.717|2.38||Null hypothesis: Fulvestrant has no difference with Anastrozole|Regression, Logistic||OR\>1 favours Fulvestrant|||2.380|0.717|0.386
73966548|NCT00274469|147469505|SUPERIORITY||Odds Ratio (OR)|1.021||||0.947|TWO_SIDED|95.0|0.556|1.874|||Regression, Logistic||OR\>1 favours Fulvestrant|||1.874|0.556|0.947
74027620|NCT03114969|147608609|SUPERIORITY||Odds Ratio (OR)|1.931||||0.12|TWO_SIDED|95.0|0.842|4.428||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.428|0.842|0.120
74027621|NCT03114969|147608609|SUPERIORITY||Odds Ratio (OR)|1.636||||0.232|TWO_SIDED|95.0|0.73|3.664||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||3.664|0.730|0.232
74027622|NCT03114969|147608610|SUPERIORITY||Odds Ratio (OR)|4.217|||<|0.001|TWO_SIDED|95.0|2.019|8.807||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||8.807|2.019|<0.001
73917010|NCT03975790|147363326|SUPERIORITY|||||||0.8363|||||||Chi-squared|||Folic Acid||||0.8363
73966549|NCT00274469|147469506|SUPERIORITY||Hazard Ratio (HR)|0.6266||||0.0496|TWO_SIDED|95.0|0.3929|0.9991|||Log Rank||HR\<1 favours Fulvestrant|||0.9991|0.3929|0.0496
73966550|NCT00274469|147469507|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.05|TWO_SIDED|95.0|0.54|1.0|||Log Rank||HR\<1 favours Fulvestrant|||1.00|0.54|0.05
74086307|NCT01118026|147726055|SUPERIORITY|||||||0.9669|||||||Log Rank|||||||0.9669
73917011|NCT03975790|147363326|SUPERIORITY|||||||0.0473|||||||Chi-squared|||Prednisone||||0.0473
73917012|NCT03975790|147363326|SUPERIORITY|||||||0.0327|||||||Chi-squared|||Prednisone||||0.0327
73917013|NCT03975790|147363326|SUPERIORITY|||||||0.5348|||||||Chi-squared|||Prednisone||||0.5348
73917014|NCT03975790|147363326|SUPERIORITY|||||||0.6934|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.6934
73917015|NCT03975790|147363326|SUPERIORITY|||||||0.6017|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.6017
73917016|NCT03975790|147363326|SUPERIORITY|||||||0.4768|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.4768
73917017|NCT03975790|147363326|SUPERIORITY|||||||0.2315|||||||Chi-squared|||Azithromycin||||0.2315
73917018|NCT03975790|147363326|SUPERIORITY|||||||0.2588|||||||Chi-squared|||Azithromycin||||0.2588
73917019|NCT03975790|147363326|SUPERIORITY|||||||0.8576|||||||Chi-squared|||Azithromycin||||0.8576
73917020|NCT03975790|147363326|SUPERIORITY|||||||0.5909|||||||Chi-squared|||Adalimumab||||0.5909
73917021|NCT03975790|147363326|SUPERIORITY|||||||0.057|||||||Chi-squared|||Adalimumab||||0.0570
73917022|NCT03975790|147363326|SUPERIORITY|||||||0.0408|||||||Chi-squared|||Adalimumab||||0.0408
73917023|NCT03975790|147363326|SUPERIORITY|||||||0.6465|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.6465
73966551|NCT00274469|147469507|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.04|TWO_SIDED|95.0|0.52|0.98|||Regression, Cox|Cox regression analysis of TTTF controlling for baseline covariates.|HR\<1 favours Fulvestrant|||0.98|0.52|0.04
73966552|NCT00274469|147469508|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.47|0.92|||Log Rank||HR\<1 favours Fulvestrant|||0.92|0.47|0.01
73966553|NCT00274469|147469508|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.01|TWO_SIDED|95.0|0.46|0.9|||Regression, Cox|Cox regression analysis of TTP (investigator assessed) controlling for baseline covariates.|HR\<1 favours Fulvestrant|||0.90|0.46|0.01
73966554|NCT00274469|147469509|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.041|TWO_SIDED|95.0|0.5|0.98|||Log Rank|||||0.98|0.50|0.041
73966555|NCT00274469|147469509|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.126|TWO_SIDED|95.0|0.54|1.08|||Regression, Cox|Cox regression analysis of OS controlling for baseline covariates|HR\<1 favours Fulvestrant|||1.08|0.54|0.126
74027623|NCT03114969|147608610|SUPERIORITY||Odds Ratio (OR)|5.41|||<|0.001|TWO_SIDED|95.0|2.66|11.005||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||11.005|2.660|<0.001
74088403|NCT00107042|147730238|SUPERIORITY_OR_OTHER||Response rate|2.58|||||TWO_SIDED|95.0|2.4|2.76|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Twinrix arm is presented here."||2.76|2.40|
73917024|NCT03975790|147363326|SUPERIORITY|||||||0.5654|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.5654
73917025|NCT03975790|147363326|SUPERIORITY|||||||0.8371|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.8371
73917026|NCT03975790|147363326|SUPERIORITY|||||||0.9654|||||||Chi-squared|||Etanercept||||0.9654
73917027|NCT03975790|147363326|SUPERIORITY|||||||0.1013|||||||Chi-squared|||Etanercept||||0.1013
73917028|NCT03975790|147363326|SUPERIORITY|||||||0.158|||||||Chi-squared|||Etanercept||||0.1580
73917029|NCT03975790|147363326|SUPERIORITY|||||||0.1663|||||||Chi-squared|||Levothyroxine Sodium||||0.1663
73917030|NCT03975790|147363326|SUPERIORITY|||||||0.6563|||||||Chi-squared|||Levothyroxine Sodium||||0.6563
73917031|NCT03975790|147363326|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium||||0.5785
73917032|NCT03975790|147363326|SUPERIORITY|||||||0.4166|||||||Chi-squared|||Methylprednisolone||||0.4166
73917033|NCT03975790|147363326|SUPERIORITY|||||||0.0636|||||||Chi-squared|||Methylprednisolone||||0.0636
73917034|NCT03975790|147363326|SUPERIORITY|||||||0.3137|||||||Chi-squared|||Methylprednisolone||||0.3137
73917035|NCT03975790|147363326|SUPERIORITY|||||||0.4568|||||||Chi-squared|||Omeprazole||||0.4568
73917036|NCT03975790|147363326|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Omeprazole||||0.5785
73917037|NCT03975790|147363326|SUPERIORITY|||||||0.9541|||||||Chi-squared|||Omeprazole||||0.9541
74086308|NCT00831233|147726061|NON_INFERIORITY_OR_EQUIVALENCE|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-2.95||||0.1973|TWO_SIDED|95.0|-7.51|1.61||FAS.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.61|-7.51|0.1973
73917038|NCT03975790|147363326|SUPERIORITY|||||||0.1956|||||||Chi-squared|||Tramadol Hydrochloride||||0.1956
73917039|NCT03975790|147363326|SUPERIORITY|||||||0.3633|||||||Chi-squared|||Tramadol Hydrochloride||||0.3633
73917040|NCT03975790|147363326|SUPERIORITY|||||||0.9481|||||||Chi-squared|||Tramadol Hydrochloride||||0.9481
73917041|NCT03975790|147363326|SUPERIORITY|||||||0.3653|||||||Chi-squared|||Meloxicam||||0.3653
73917042|NCT03975790|147363326|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Meloxicam||||0.9255
73917043|NCT03975790|147363326|SUPERIORITY|||||||0.5137|||||||Chi-squared|||Meloxicam||||0.5137
73917044|NCT03975790|147363326|SUPERIORITY|||||||0.6338|||||||Chi-squared|||Amoxicillin||||0.6338
73917045|NCT03975790|147363326|SUPERIORITY|||||||0.6329|||||||Chi-squared|||Amoxicillin||||0.6329
73917046|NCT03975790|147363326|SUPERIORITY|||||||0.9228|||||||Chi-squared|||Amoxicillin||||0.9228
73917047|NCT03975790|147363326|SUPERIORITY|||||||0.8433|||||||Chi-squared|||Albuterol Sulfate||||0.8433
73917048|NCT03975790|147363326|SUPERIORITY|||||||0.1175|||||||Chi-squared|||Albuterol Sulfate||||0.1175
73917049|NCT03975790|147363326|SUPERIORITY|||||||0.1215|||||||Chi-squared|||Albuterol Sulfate||||0.1215
73917050|NCT03975790|147363326|SUPERIORITY|||||||0.9007|||||||Chi-squared|||Gabapentin||||0.9007
73917051|NCT03975790|147363326|SUPERIORITY|||||||0.8789|||||||Chi-squared|||Gabapentin||||0.8789
73917052|NCT03975790|147363326|SUPERIORITY|||||||0.8305|||||||Chi-squared|||Gabapentin||||0.8305
73917053|NCT03975790|147363326|SUPERIORITY|||||||0.0694|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.0694
73917054|NCT03975790|147363326|SUPERIORITY|||||||0.8606|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.8606
73917055|NCT03975790|147363326|SUPERIORITY|||||||0.3363|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.3363
73917056|NCT03975790|147363326|SUPERIORITY|||||||0.3319|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.3319
73917057|NCT03975790|147363326|SUPERIORITY|||||||0.5615|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.5615
73917058|NCT03975790|147363326|SUPERIORITY|||||||0.8898|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.8898
73917059|NCT03975790|147363326|SUPERIORITY|||||||0.367|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.3670
73917060|NCT03975790|147363326|SUPERIORITY|||||||0.8155|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.8155
73917061|NCT03975790|147363326|SUPERIORITY|||||||0.7091|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.7091
73917062|NCT03975790|147363326|SUPERIORITY|||||||0.9769|||||||Chi-squared|||Fluticasone Propionate||||0.9769
73917063|NCT03975790|147363326|SUPERIORITY|||||||0.5032|||||||Chi-squared|||Fluticasone Propionate||||0.5032
73917064|NCT03975790|147363326|SUPERIORITY|||||||0.5631|||||||Chi-squared|||Fluticasone Propionate||||0.5631
73917065|NCT03975790|147363326|SUPERIORITY|||||||0.4426|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.4426
73917066|NCT03975790|147363326|SUPERIORITY|||||||0.5734|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.5734
73917067|NCT03975790|147363326|SUPERIORITY|||||||0.3071|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.3071
73917068|NCT03975790|147363326|SUPERIORITY|||||||0.1608|||||||Chi-squared|||Duloxetine Hydrochloride||||0.1608
73917069|NCT03975790|147363326|SUPERIORITY|||||||0.4092|||||||Chi-squared|||Duloxetine Hydrochloride||||0.4092
73917070|NCT03975790|147363326|SUPERIORITY|||||||0.1215|||||||Chi-squared|||Duloxetine Hydrochloride||||0.1215
73917071|NCT03975790|147363326|SUPERIORITY|||||||0.7279|||||||Chi-squared|||Atorvastatin Calcium||||0.7279
73917072|NCT03975790|147363326|SUPERIORITY|||||||0.7703|||||||Chi-squared|||Atorvastatin Calcium||||0.7703
73917073|NCT03975790|147363326|SUPERIORITY|||||||0.6254|||||||Chi-squared|||Atorvastatin Calcium||||0.6254
73917074|NCT03975790|147363326|SUPERIORITY|||||||0.1615|||||||Chi-squared|||Diclofenac Sodium||||0.1615
73917075|NCT03975790|147363326|SUPERIORITY|||||||0.505|||||||Chi-squared|||Diclofenac Sodium||||0.5050
73917076|NCT03975790|147363326|SUPERIORITY|||||||0.1592|||||||Chi-squared|||Diclofenac Sodium||||0.1592
73917077|NCT03975790|147363326|SUPERIORITY|||||||0.6088|||||||Chi-squared|||Levofloxacin||||0.6088
73917078|NCT03975790|147363326|SUPERIORITY|||||||0.4713|||||||Chi-squared|||Levofloxacin||||0.4713
74086309|NCT00831233|147726061|NON_INFERIORITY_OR_EQUIVALENCE|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-5.88||||0.0398|TWO_SIDED|95.0|-11.5|-0.291||PP analysis set.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||-0.291|-11.5|0.0398
74086310|NCT00831233|147726062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47||||0.2298|TWO_SIDED|95.0|-6.58|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.64|-6.58|0.2298
74086311|NCT00831233|147726062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.983||||0.6917|TWO_SIDED|95.0|-5.98|4.02|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||4.02|-5.98|0.6917
73917079|NCT03975790|147363326|SUPERIORITY|||||||0.3399|||||||Chi-squared|||Levofloxacin||||0.3399
73917080|NCT03975790|147363327|SUPERIORITY|||||||0.2349|||||||Chi-squared|||MTX Sodium||||0.2349
73917081|NCT03975790|147363327|SUPERIORITY|||||||0.3956|||||||Chi-squared|||MTX Sodium||||0.3956
73917082|NCT03975790|147363327|SUPERIORITY|||||||0.55|||||||Chi-squared|||Folic Acid||||0.5500
73917083|NCT03975790|147363327|SUPERIORITY|||||||0.7131|||||||Chi-squared|||Folic Acid||||0.7131
73917084|NCT03975790|147363327|SUPERIORITY|||||||0.942|||||||Chi-squared|||Folic Acid||||0.9420
73917085|NCT03975790|147363327|SUPERIORITY|||||||0.0571|||||||Chi-squared|||Prednisone||||0.0571
73917086|NCT03975790|147363327|SUPERIORITY|||||||0.049|||||||Chi-squared|||Prednisone||||0.0490
73917087|NCT03975790|147363327|SUPERIORITY|||||||0.5631|||||||Chi-squared|||Prednisone||||0.5631
73917088|NCT03975790|147363327|SUPERIORITY|||||||0.2198|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.2198
74086312|NCT00831233|147726063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.553||||0.8151|TWO_SIDED|95.0|-5.33|4.22|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||4.22|-5.33|0.8151
74086313|NCT00831233|147726063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.455|TWO_SIDED|95.0|-2.46|5.38|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||5.38|-2.46|0.455
73917089|NCT03975790|147363327|SUPERIORITY|||||||0.385|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.3850
73917090|NCT03975790|147363327|SUPERIORITY|||||||0.1165|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.1165
73917091|NCT03975790|147363327|SUPERIORITY|||||||0.4291|||||||Chi-squared|||Azithromycin||||0.4291
73917092|NCT03975790|147363327|SUPERIORITY|||||||0.385|||||||Chi-squared|||Azithromycin||||0.3850
73917093|NCT03975790|147363327|SUPERIORITY|||||||0.8143|||||||Chi-squared|||Azithromycin||||0.8143
73917094|NCT03975790|147363327|SUPERIORITY|||||||0.7272|||||||Chi-squared|||Adalimumab||||0.7272
73917095|NCT03975790|147363327|SUPERIORITY|||||||0.0501|||||||Chi-squared|||Adalimumab||||0.0501
73917096|NCT03975790|147363327|SUPERIORITY|||||||0.05|||||||Chi-squared|||Adalimumab||||0.0500
73917097|NCT03975790|147363327|SUPERIORITY|||||||0.3116|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.3116
73917098|NCT03975790|147363327|SUPERIORITY|||||||0.4882|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.4882
73917099|NCT03975790|147363327|SUPERIORITY|||||||0.9505|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.9505
73917100|NCT03975790|147363327|SUPERIORITY|||||||0.408|||||||Chi-squared|||Etanercept||||0.4080
73917101|NCT03975790|147363327|SUPERIORITY|||||||0.7644|||||||Chi-squared|||Etanercept||||0.7644
73917102|NCT03975790|147363327|SUPERIORITY|||||||0.4146|||||||Chi-squared|||Etanercept||||0.4146
73917103|NCT03975790|147363327|SUPERIORITY|||||||0.1348|||||||Chi-squared|||Levothyroxine Sodium||||0.1348
73917104|NCT03975790|147363327|SUPERIORITY|||||||0.5948|||||||Chi-squared|||Levothyroxine Sodium||||0.5948
73917105|NCT03975790|147363327|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium||||0.5785
73917106|NCT03975790|147363327|SUPERIORITY|||||||0.1033|||||||Chi-squared|||Methylprednisolone||||0.1033
73917107|NCT03975790|147363327|SUPERIORITY|||||||0.2117|||||||Chi-squared|||Methylprednisolone||||0.2117
73917108|NCT03975790|147363327|SUPERIORITY|||||||0.992|||||||Chi-squared|||Methylprednisolone||||0.9920
73917109|NCT03975790|147363327|SUPERIORITY|||||||0.9212|||||||Chi-squared|||Omeprazole||||0.9212
73917110|NCT03975790|147363327|SUPERIORITY|||||||0.9212|||||||Chi-squared|||Omeprazole||||0.9212
73917111|NCT03975790|147363327|SUPERIORITY|||||||0.4384|||||||Chi-squared|||Omeprazole||||0.4384
73917112|NCT03975790|147363327|SUPERIORITY|||||||0.0162|||||||Chi-squared|||Tramadol Hydrochloride||||0.0162
73917113|NCT03975790|147363327|SUPERIORITY|||||||0.3239|||||||Chi-squared|||Tramadol Hydrochloride||||0.3239
73917114|NCT03975790|147363327|SUPERIORITY|||||||0.4837|||||||Chi-squared|||Tramadol Hydrochloride||||0.4837
73917115|NCT03975790|147363327|SUPERIORITY|||||||0.7183|||||||Chi-squared|||Meloxicam||||0.7183
73917116|NCT03975790|147363327|SUPERIORITY|||||||0.2667|||||||Chi-squared|||Meloxicam||||0.2667
73917117|NCT03975790|147363327|SUPERIORITY|||||||0.451|||||||Chi-squared|||Meloxicam||||0.4510
73917118|NCT03975790|147363327|SUPERIORITY|||||||0.7993|||||||Chi-squared|||Amoxicillin||||0.7993
73917119|NCT03975790|147363327|SUPERIORITY|||||||0.9896|||||||Chi-squared|||Amoxicillin||||0.9896
73917120|NCT03975790|147363327|SUPERIORITY|||||||0.8576|||||||Chi-squared|||Amoxicillin||||0.8576
73917121|NCT03975790|147363327|SUPERIORITY|||||||0.9373|||||||Chi-squared|||Albuterol Sulfate||||0.9373
73917122|NCT03975790|147363327|SUPERIORITY|||||||0.1253|||||||Chi-squared|||Albuterol Sulfate||||0.1253
73860539|NCT01294462|147267003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72|||||TWO_SIDED|95.0|1.23|2.4||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison.||2.40|1.23|
73860540|NCT01294462|147267004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||||TWO_SIDED|95.0|0.91|2.5||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.||2.50|0.91|
73917123|NCT03975790|147363327|SUPERIORITY|||||||0.1851|||||||Chi-squared|||Albuterol Sulfate||||0.1851
73860541|NCT02076399|147267005|SUPERIORITY||Risk Difference (RD)|17.6||||0.0261|TWO_SIDED|95.0|7.2|28.1|||Fisher Exact|||||28.1|7.2|0.0261
74086314|NCT00831233|147726063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.3186|TWO_SIDED|95.0|-2.04|6.08|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||6.08|-2.04|0.3186
73860542|NCT02076399|147267010|SUPERIORITY||Risk Difference (RD)|-0.01||||0.6642|TWO_SIDED|95.0|-0.01|0.0||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.0|-0.01|0.6642
73860543|NCT02076399|147267011|SUPERIORITY||Risk Difference (RD)|0.15||||0.3365|TWO_SIDED|95.0|-0.2|0.5||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.5|-0.2|0.3365
73860544|NCT00085254|147267014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4|TWO_SIDED|95.0|0.5|1.3|||Regression, Cox|||||1.3|0.5|0.4
73860545|NCT00085254|147267016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39||||0.0001|TWO_SIDED|95.0|0.3|0.5||adjusted for age: p=.0003, kps: p=.004; and surgical procedure: p=.003|Log Rank|||Primary endpoint death - defined from histological diagnosis to death. we assume pt in the study will have overall failure rate of 0.56 per person-year of f/up, a 30% reduction compared to hazard rate of 0.8 per person-year in historical NABTT database. Expected hazard ratio is 0.7 and cohort will produce 63 events among total of 94 pt planned f/up. One-sided test, have 95% power to detect observed ratio of 0.7 at alpha level of 0.1, or we have 88% power at alpha of 0.5 statistical significant||0.5|0.3|0.0001
73860546|NCT04342689|147267019|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||0.99
73860547|NCT04342689|147267020|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
73860548|NCT04342689|147267021|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
73860549|NCT01460407|147267024|SUPERIORITY_OR_OTHER||Ratio of geometric LS mean|1.28|||||TWO_SIDED|90.0|1.16|1.42|||||Ratio of LY2216684 and Clarithromycin to LY2216684|||1.42|1.16|
73860550|NCT01460407|147267025|SUPERIORITY_OR_OTHER||Ratio of geometric LS mean|1.21|||||TWO_SIDED|90.0|1.12|1.31|||||Ratio of LY2216684 and Clarithromycin to LY2216684|||1.31|1.12|
73917124|NCT03975790|147363327|SUPERIORITY|||||||0.8697|||||||Chi-squared|||Gabapentin||||0.8697
73860551|NCT01460407|147267026|SUPERIORITY_OR_OTHER||Median of paired differences|0.0||||0.7656|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||LY2216684 and Clarithromycin minus (-) LY2216684|||0.50|-0.50|0.7656
73917125|NCT03975790|147363327|SUPERIORITY|||||||0.9719|||||||Chi-squared|||Gabapentin||||0.9719
73917126|NCT03975790|147363327|SUPERIORITY|||||||0.938|||||||Chi-squared|||Gabapentin||||0.9380
73860552|NCT01400243|147267035|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANCOVA|||||||.05
73860553|NCT01400243|147267036|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73860554|NCT02193087|147267040|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.29|||||TWO_SIDED|90.0|0.23|0.36||||||DEN-1||0.36|0.23|
73860555|NCT02193087|147267040|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.06|||||TWO_SIDED|90.0|0.9|1.26||||||DEN-2||1.26|0.90|
73860556|NCT02193087|147267040|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.46|||||TWO_SIDED|90.0|1.13|1.89||||||DEN-3||1.89|1.13|
73860557|NCT02193087|147267040|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.74|||||TWO_SIDED|90.0|0.57|0.95||||||DEN-4||0.95|0.57|
73860558|NCT00946322|147267066|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.028
73860559|NCT00946322|147267067|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-tests were used. Due to variable skewness, variables were logarithm-transformed to improve their distributions.||||.022
73860560|NCT00946322|147267068|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.043
73860561|NCT00946322|147267069|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.482
73860562|NCT00946322|147267070|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.009
73860563|NCT00946322|147267071|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.001
73917127|NCT03975790|147363327|SUPERIORITY|||||||0.1079|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.1079
73917128|NCT03975790|147363327|SUPERIORITY|||||||0.2588|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.2588
73917129|NCT03975790|147363327|SUPERIORITY|||||||0.9358|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.9358
73917130|NCT03975790|147363327|SUPERIORITY|||||||0.1984|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.1984
73917131|NCT03975790|147363327|SUPERIORITY|||||||0.8542|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.8542
73917132|NCT03975790|147363327|SUPERIORITY|||||||0.2973|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.2973
73917133|NCT03975790|147363327|SUPERIORITY|||||||0.1046|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.1046
74086315|NCT00831233|147726064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.2||||0.5627|TWO_SIDED|95.0|-37.8|68.2|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||68.2|-37.8|0.5627
74086316|NCT00831233|147726064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91||||0.8284|TWO_SIDED|95.0|-49.1|60.9|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||60.9|-49.1|0.8284
74086317|NCT00831233|147726064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.2||||0.5984|TWO_SIDED|95.0|-34.4|58.8|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||58.8|-34.4|0.5984
74086318|NCT00831233|147726065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.83||||0.1018|TWO_SIDED|95.0|-17.3|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.64|-17.3|0.1018
74086319|NCT02760264|147726078|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
74086320|NCT02760264|147726080|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
74086321|NCT02760264|147726082|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
74086322|NCT02760264|147726083|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
74086323|NCT02760264|147726085|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
74086324|NCT02760264|147726087|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
74086325|NCT01796964|147726095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority at week 12 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 - EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-1.13|||||TWO_SIDED|80.0|-4.19|1.93|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (\< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 - EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 12.||1.93|-4.19|
73860564|NCT00946322|147267072|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.027
74086326|NCT01796964|147726096|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority at week 16 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 - EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-0.58|||||TWO_SIDED|80.0|-3.72|2.56|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (\< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 - EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 16.||2.56|-3.72|
74086327|NCT04025684|147726104|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.11|-0.08||Analysis was performed using ANCOVA Model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.11|<.0001
73860565|NCT00946322|147267073|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.177
73860566|NCT02032641|147267075|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05|t-test, 1 sided|||||||<0.05
73860567|NCT02032641|147267075|SUPERIORITY_OR_OTHER||||||>|0.1||||||The threshold for significance is p\<0.05|t-test, 1 sided|||||||>0.10
74086328|NCT04025684|147726104|SUPERIORITY||Adjusted Mean Change|-0.12|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.14|-0.1||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.10|-0.14|<0.0001
73860568|NCT01822535|147267087|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Between-group differences in percent changes in core body temperature from baseline values to after cool exposure were analyzed. Because individuals with tetraplegia have impaired thermoregulatory mechanisms, we hypothesized that their percent change in core body temperature would be significantly larger than that of able-bodied controls.||||<0.01
73860569|NCT01822535|147267088|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANOVA|||"Between-group comparisons of percent changes in Stroop Interference T-scores from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."||||0.018
73860570|NCT01822535|147267089|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED||||||ANOVA|||"Between-group comparisons of percent changes in Delayed Recall from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."||||0.0431
73917134|NCT03975790|147363327|SUPERIORITY|||||||0.7961|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.7961
73860571|NCT01822535|147267090|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||"We hypothesized that administration of midodrine would attenuate the fall in core body temperature.~Within-group percent changes in core body temperature were analyzed to compare data from visit 1 (no drug) to visit 2 (drug)."||||0.30
73917135|NCT03975790|147363327|SUPERIORITY|||||||0.214|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.2140
73917136|NCT03975790|147363327|SUPERIORITY|||||||0.8578|||||||Chi-squared|||Fluticasone Propionate||||0.8578
73917137|NCT03975790|147363327|SUPERIORITY|||||||0.7131|||||||Chi-squared|||Fluticasone Propionate||||0.7131
73917138|NCT03975790|147363327|SUPERIORITY|||||||0.8421|||||||Chi-squared|||Fluticasone Propionate||||0.8421
73917139|NCT03975790|147363327|SUPERIORITY|||||||0.7637|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.7637
73917140|NCT03975790|147363327|SUPERIORITY|||||||0.6355|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.6355
74027624|NCT03114969|147608611|SUPERIORITY||Odds Ratio (OR)|2.477||||0.007|TWO_SIDED|95.0|1.274|4.815||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||4.815|1.274|0.007
73860572|NCT02278614|147267091|OTHER|The change from baseline in mean IOP on Day 84 for the contralateral eye,|Adjusted mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.57|0.43|||Mixed Models Analysis|||||0.43|-0.57|
73860573|NCT02278614|147267091|OTHER|The change from baseline in mean IOP on D42 for the worse eye|Adjusted mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|-0.69|0.31|||Mixed Models Analysis|||||0.31|-0.69|
73860574|NCT01048866|147267106|SUPERIORITY_OR_OTHER||least-square means difference|-196.6||||0.0021|TWO_SIDED|95.0|-321.0|-72.2||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-72.2|-321.0|0.0021
73860575|NCT01048866|147267107|SUPERIORITY_OR_OTHER||least-square means difference|-19.0||||0.0002|TWO_SIDED|95.0|-28.7|-9.3||The a priori threshold for statistical significance is 0.05.|ANOVA|Baseline DSS fitted as a covariate and centre as a fixed effect.||||-9.3|-28.7|0.0002
73860576|NCT01048866|147267108|SUPERIORITY_OR_OTHER||least-square means difference|-179.7||||0.0054|TWO_SIDED|95.0|-305.7|-53.8||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-53.8|-305.7|0.0054
73860577|NCT01048866|147267109|SUPERIORITY_OR_OTHER||least-square means difference|-16.4||||0.0008|TWO_SIDED|95.0|-25.9|-7.0||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-7.0|-25.9|0.0008
73860578|NCT01048866|147267110|SUPERIORITY_OR_OTHER||least-square means difference|-168.4||||0.0087|TWO_SIDED|95.0|-293.7|-43.1|||ANOVA|||||-43.1|-293.7|0.0087
73860579|NCT01048866|147267111|SUPERIORITY_OR_OTHER||least-square means difference|-19.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-10.0|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.||||-10.0|-28.0|<0.0001
73860580|NCT01048866|147267112|SUPERIORITY_OR_OTHER||least-square means difference|-118.9||||0.1844|TWO_SIDED|95.0|-295.3|57.5|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.||||57.5|-295.3|0.1844
73860581|NCT01048866|147267113|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73860582|NCT01048866|147267114|SUPERIORITY_OR_OTHER|||||||0.8827|||||||Wilcoxon (Mann-Whitney)|||||||0.8827
73917141|NCT03975790|147363327|SUPERIORITY|||||||0.5425|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.5425
74027625|NCT03114969|147608611|SUPERIORITY||Odds Ratio (OR)|2.748||||0.006|TWO_SIDED|95.0|1.328|5.683||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.683|1.328|0.006
73860583|NCT01048866|147267115|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Wilcoxon (Mann-Whitney)|Stratified by centre||||||0.0105
73860584|NCT01048866|147267117|SUPERIORITY_OR_OTHER||least-square means difference|-5.9||||0.0743|TWO_SIDED|95.0|-12.4|0.6|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.6|-12.4|0.0743
73860585|NCT01048866|147267118|SUPERIORITY_OR_OTHER||least-square means difference|-5.5||||0.0871|TWO_SIDED|95.0|-11.7|0.8|||ANOVA|Repeated measures ANOVA model with patient as a random effect.||||0.8|-11.7|0.0871
73860586|NCT01048866|147267119|SUPERIORITY_OR_OTHER||least-square means difference|-6.0||||0.0595|TWO_SIDED|95.0|-12.3|0.2|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.2|-12.3|0.0595
73860587|NCT01048866|147267120|SUPERIORITY_OR_OTHER||least-square means difference|0.5||||0.0195|TWO_SIDED|95.0|0.1|0.9|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.9|0.1|0.0195
73860588|NCT01048866|147267121|SUPERIORITY_OR_OTHER|||||||0.0322|||||||Regression, Logistic|Effect for centre||||||0.0322
73860589|NCT01048866|147267122|SUPERIORITY_OR_OTHER|||||||0.0276|||||||Log Rank|||||||0.0276
73860590|NCT01048866|147267123|SUPERIORITY_OR_OTHER||least-square means difference|-0.2||||0.0288|TWO_SIDED|95.0|-0.4|0.0|||ANOVA|||||-0.0|-0.4|0.0288
73860591|NCT01048866|147267124|SUPERIORITY_OR_OTHER||least-square means difference|-0.1||||0.4274|TWO_SIDED|95.0|-0.3|0.1|||ANOVA|||||0.1|-0.3|0.4274
73917142|NCT03975790|147363327|SUPERIORITY|||||||0.041|||||||Chi-squared|||Duloxetine Hydrochloride||||0.0410
73917143|NCT03975790|147363327|SUPERIORITY|||||||0.8251|||||||Chi-squared|||Duloxetine Hydrochloride||||0.8251
73917144|NCT03975790|147363327|SUPERIORITY|||||||0.2871|||||||Chi-squared|||Duloxetine Hydrochloride||||0.2871
73917145|NCT03975790|147363327|SUPERIORITY|||||||0.1174|||||||Chi-squared|||Diclofenac Sodium||||0.1174
73917146|NCT03975790|147363327|SUPERIORITY|||||||0.9702|||||||Chi-squared|||Diclofenac Sodium||||0.9702
73917147|NCT03975790|147363327|SUPERIORITY|||||||0.3109|||||||Chi-squared|||Diclofenac Sodium||||0.3109
73917148|NCT03975790|147363327|SUPERIORITY|||||||0.6744|||||||Chi-squared|||Levofloxacin||||0.6744
73917149|NCT03975790|147363327|SUPERIORITY|||||||0.8121|||||||Chi-squared|||Levofloxacin||||0.8121
73917150|NCT03975790|147363327|SUPERIORITY|||||||0.9451|||||||Chi-squared|||Levofloxacin||||0.9451
73917151|NCT03975790|147363327|SUPERIORITY|||||||0.166|||||||Chi-squared|||Cephalexin||||0.1660
73917152|NCT03975790|147363327|SUPERIORITY|||||||0.9549|||||||Chi-squared|||Cephalexin||||0.9549
73917153|NCT03975790|147363327|SUPERIORITY|||||||0.3104|||||||Chi-squared|||Cephalexin||||0.3104
73917154|NCT03975790|147363327|SUPERIORITY|||||||0.0489|||||||Chi-squared|||Ibuprofen||||0.0489
73917155|NCT03975790|147363327|SUPERIORITY|||||||0.1515|||||||Chi-squared|||Ibuprofen||||0.1515
73917156|NCT03975790|147363327|SUPERIORITY|||||||0.9481|||||||Chi-squared|||Ibuprofen||||0.9481
74086329|NCT04025684|147726104|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.12|-0.08||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.12|<0.0001
74086330|NCT04025684|147726104|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.12|-0.08||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.12|<0.0001
74086331|NCT04025684|147726105|SUPERIORITY||Adjusted Mean Change|-0.5|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|-0.62|-0.37||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.37|-0.62|<0.0001
74086332|NCT04025684|147726105|SUPERIORITY||Adjusted Mean Change|-0.62|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.75|-0.49||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.49|-0.75|<0.0001
74086333|NCT04025684|147726105|SUPERIORITY||Adjusted Mean Change|-0.55|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.68|-0.42||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.42|-0.68|<0.0001
74086334|NCT04025684|147726105|SUPERIORITY||Adjusted Mean Change|-0.57|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.7|-0.44||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.44|-0.70|<0.0001
74086335|NCT02070757|147726121|NON_INFERIORITY|Meropenem minus ceftolozane/tazobactam. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -10%.|Difference in Percentage of Participants|1.1|||||TWO_SIDED|95.0|-5.13|7.39|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.|||7.39|-5.13|
73917157|NCT03975790|147363328|SUPERIORITY|||||||0.2178|||||||Chi-squared|||||||0.2178
73917158|NCT03975790|147363328|SUPERIORITY|||||||0.5237|||||||Chi-squared|||||||0.5237
74086336|NCT02070757|147726122|NON_INFERIORITY|Clinical Response difference is calculated as ceftolozane/tazobactam minus meropenem. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -12.5%.|Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-6.17|8.29|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.|||8.29|-6.17|
74086337|NCT02070757|147726123|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|4.4|||||TWO_SIDED|95.0|-2.83|11.75|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||11.75|-2.83|
74086338|NCT02070757|147726124|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-1.3|||||TWO_SIDED|95.0|-10.21|7.67|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||7.67|-10.21|
73917159|NCT03975790|147363328|SUPERIORITY|||||||0.7964|||||||Chi-squared|||||||0.7964
74086339|NCT02070757|147726125|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|7.0||||||95.0|-5.11|18.93|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||18.93|-5.11|
73917160|NCT03975790|147363329|SUPERIORITY|||||||0.9085|||||||Chi-squared|||||||0.9085
73917161|NCT03975790|147363329|SUPERIORITY|||||||0.6283|||||||Chi-squared|||||||0.6283
73917162|NCT03975790|147363329|SUPERIORITY|||||||0.7293|||||||Chi-squared|||||||0.7293
73917163|NCT03975790|147363330|SUPERIORITY|||||||0.9392|||||||Chi-squared|||||||0.9392
73917164|NCT03975790|147363330|SUPERIORITY|||||||0.3063|||||||Chi-squared|||||||0.3063
73917165|NCT03975790|147363330|SUPERIORITY|||||||0.3467|||||||Chi-squared|||||||0.3467
73917166|NCT03975790|147363331|SUPERIORITY|||||||0.7977|||||||Chi-squared|||||||0.7977
73917167|NCT03975790|147363331|SUPERIORITY|||||||0.5241|||||||Chi-squared|||||||0.5241
73917168|NCT03975790|147363331|SUPERIORITY|||||||0.4702|||||||Chi-squared|||||||0.4702
73917169|NCT03975790|147363332|SUPERIORITY|||||||0.1461|||||||t-test|||||||0.1461
73917170|NCT03975790|147363332|SUPERIORITY|||||||0.1411|||||||t-test|||||||0.1411
73917171|NCT03975790|147363332|SUPERIORITY|||||||0.4201|||||||t-test|||||||0.4201
73917172|NCT03975790|147363333|SUPERIORITY|||||||0.3955|||||||t-test|||||||0.3955
73917173|NCT03975790|147363333|SUPERIORITY|||||||0.6356|||||||t-test|||||||0.6356
73917174|NCT03975790|147363333|SUPERIORITY|||||||0.3833|||||||t-test|||||||0.3833
74086340|NCT02070757|147726127|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-1.4|||||TWO_SIDED|95.0|-6.41|3.57|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||3.57|-6.41|
74086341|NCT02070757|147726128|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-0.8|||||TWO_SIDED|95.0|-7.67|6.04|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||6.04|-7.67|
74086342|NCT02070757|147726129|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|1.6|||||TWO_SIDED|95.0|-8.91|12.02|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||12.02|-8.91|
74086343|NCT02070757|147726130|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|3.3|||||TWO_SIDED|95.0|-3.38|10.44|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||10.44|-3.38|
74086344|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rivermead Behavioural Memory Test (RBMT) - Immediate memory||||0.861
74086345|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.668||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT - Delayed memory||||0.668
74086346|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT-Delayed corrected for immediate memory||||0.713
74086347|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.028||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Short-term memory||||0.028
74086348|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.227||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Total immediate memory||||0.227
74086349|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.13||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Learning Score||||0.130
74086350|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.106||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test- Delayed memory||||0.106
74086351|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.35||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Delayed corrected for total memory||||0.350
74086352|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.093||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Recognition||||0.093
74086353|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.614||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit Span forward - Short-term memory||||0.614
74086354|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.111||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Immediate memory||||0.111
73917175|NCT03975790|147363334|SUPERIORITY|||||||0.3292|||||||t-test|||||||0.3292
73917176|NCT03975790|147363334|SUPERIORITY|||||||0.2959|||||||t-test|||||||0.2959
74086355|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.451||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Delayed memory||||0.451
74086356|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.905||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time auditory response||||0.905
74086357|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.502||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time visual response||||0.502
74086358|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.531||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of omission errors||||0.531
73917177|NCT03975790|147363334|SUPERIORITY|||||||0.6962|||||||t-test|||||||0.6962
74086359|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.681||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of commission errors||||0.681
73917178|NCT03975790|147363335|SUPERIORITY|||||||0.8138|||||||t-test|||||||0.8138
73917179|NCT03975790|147363335|SUPERIORITY|||||||0.007|||||||t-test|||||||0.0070
73917180|NCT03975790|147363335|SUPERIORITY|||||||0.0358|||||||t-test|||||||0.0358
73917181|NCT03975790|147363336|SUPERIORITY|||||||0.8453|||||||t-test|||||||0.8453
73917182|NCT03975790|147363336|SUPERIORITY|||||||0.4806|||||||t-test|||||||0.4806
73917183|NCT03975790|147363336|SUPERIORITY|||||||0.4809|||||||t-test|||||||0.4809
73917184|NCT03975790|147363337|SUPERIORITY|||||||0.3076|||||||t-test|||||||0.3076
73917185|NCT03975790|147363337|SUPERIORITY|||||||0.2509|||||||t-test|||||||0.2509
73917186|NCT03975790|147363337|SUPERIORITY|||||||0.7827|||||||t-test|||||||0.7827
73917187|NCT03975790|147363338|SUPERIORITY|||||||0.4261|||||||Chi-squared|||During Persistency||||0.4261
74086360|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Reaction time for target stimuli||||0.713
74086361|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.229||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of omission errors||||0.229
73917188|NCT03975790|147363338|SUPERIORITY|||||||0.5247|||||||Chi-squared|||During Persistency||||0.5247
73917189|NCT03975790|147363338|SUPERIORITY|||||||0.2809|||||||Chi-squared|||During Persistency||||0.2809
73917190|NCT03975790|147363338|SUPERIORITY|||||||0.1153|||||||Chi-squared|||Post Persistency||||0.1153
73917191|NCT03975790|147363338|SUPERIORITY|||||||0.1344|||||||Chi-squared|||Post Persistency||||0.1344
73917192|NCT03975790|147363338|SUPERIORITY|||||||0.8229|||||||Chi-squared|||Post Persistency||||0.8229
73917193|NCT03975790|147363339|SUPERIORITY|||||||0.7816|||||||Chi-squared|||During Persistency||||0.7816
73917194|NCT03975790|147363339|SUPERIORITY|||||||0.7124|||||||Chi-squared|||During Persistency||||0.7124
73917195|NCT03975790|147363339|SUPERIORITY|||||||0.6148|||||||Chi-squared|||During Persistency||||0.6148
73917196|NCT03975790|147363339|SUPERIORITY|||||||0.4876|||||||Chi-squared|||Post Persistency||||0.4876
73917197|NCT03975790|147363339|SUPERIORITY|||||||0.7826|||||||Chi-squared|||Post Persistency||||0.7826
74086362|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.329||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of commission errors||||0.329
74086363|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.192||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time tonic alertness||||0.192
73917198|NCT03975790|147363339|SUPERIORITY|||||||0.8337|||||||Chi-squared|||Post Persistency||||0.8337
73917199|NCT03975790|147363340|SUPERIORITY|||||||0.1344|||||||Chi-squared|||||||0.1344
73917200|NCT03975790|147363340|SUPERIORITY|||||||0.0095|||||||Chi-squared|||||||0.0095
73917201|NCT03975790|147363340|SUPERIORITY|||||||0.1406|||||||Chi-squared|||||||0.1406
73917202|NCT03975790|147363341|SUPERIORITY|||||||0.9379|||||||Chi-squared|||||||0.9379
74086364|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.164||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time phasic alertness||||0.164
74086365|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.536||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Semantic fluency||||0.536
73917203|NCT03975790|147363341|SUPERIORITY|||||||0.3025|||||||Chi-squared|||||||0.3025
73917204|NCT03975790|147363341|SUPERIORITY|||||||0.3388|||||||Chi-squared|||||||0.3388
73917205|NCT03975790|147363342|SUPERIORITY|||||||0.8205|||||||t-test|||||||0.8205
73917206|NCT03975790|147363342|SUPERIORITY|||||||0.0467|||||||t-test|||||||0.0467
73917207|NCT03975790|147363342|SUPERIORITY|||||||0.1083|||||||t-test|||||||0.1083
73917208|NCT03975790|147363343|SUPERIORITY|||||||0.8899|||||||t-test|||||||0.8899
73917209|NCT03975790|147363343|SUPERIORITY|||||||0.6183|||||||t-test|||||||0.6183
73917210|NCT03975790|147363343|SUPERIORITY|||||||0.6496|||||||t-test|||||||0.6496
73917211|NCT03975790|147363344|SUPERIORITY|||||||0.5027|||||||t-test|||||||0.5027
73917212|NCT03975790|147363344|SUPERIORITY|||||||0.2375|||||||t-test|||||||0.2375
73917213|NCT03975790|147363344|SUPERIORITY|||||||0.5577|||||||t-test|||||||0.5577
73917214|NCT03975790|147363345|SUPERIORITY|||||||0.6908|||||||t-test|||||||0.6908
73917215|NCT03975790|147363345|SUPERIORITY|||||||0.0859|||||||t-test|||||||0.0859
73917216|NCT03975790|147363345|SUPERIORITY|||||||0.2764|||||||t-test|||||||0.2764
73917217|NCT03975790|147363346|SUPERIORITY|||||||0.1906|||||||t-test|||||||0.1906
73917218|NCT03975790|147363346|SUPERIORITY|||||||0.8744|||||||t-test|||||||0.8744
73917219|NCT03975790|147363346|SUPERIORITY|||||||0.3295|||||||t-test|||||||0.3295
73917220|NCT03975790|147363347|SUPERIORITY|||||||0.0056|||||||t-test|||All cause||||0.0056
73917221|NCT03975790|147363347|SUPERIORITY|||||||0.4222|||||||t-test|||All cause||||0.4222
73917222|NCT03975790|147363347|SUPERIORITY|||||||0.0041|||||||t-test|||All cause||||0.0041
73917223|NCT03975790|147363347|SUPERIORITY|||||||0.2277|||||||t-test|||RA related||||0.2277
73917224|NCT03975790|147363347|SUPERIORITY|||||||0.2812|||||||t-test|||RA related||||0.2812
73917225|NCT03975790|147363347|SUPERIORITY|||||||0.0772|||||||t-test|||RA related||||0.0772
73917226|NCT03975790|147363348|SUPERIORITY|||||||0.293|||||||t-test|||All cause||||0.2930
73917227|NCT03975790|147363348|SUPERIORITY|||||||0.439|||||||t-test|||All cause||||0.4390
73917228|NCT03975790|147363348|SUPERIORITY|||||||0.153|||||||t-test|||All cause||||0.1530
73917229|NCT03975790|147363348|SUPERIORITY|||||||0.9439|||||||t-test|||RA related||||0.9439
73917230|NCT03975790|147363348|SUPERIORITY|||||||0.4477|||||||t-test|||RA related||||0.4477
73917231|NCT03975790|147363348|SUPERIORITY|||||||0.4519|||||||t-test|||RA related||||0.4519
73917232|NCT03975790|147363349|SUPERIORITY|||||||0.9829|||||||Chi-squared|||Cardiovascular Disease||||0.9829
73917233|NCT03975790|147363349|SUPERIORITY|||||||0.8021|||||||Chi-squared|||Cardiovascular Disease||||0.8021
73917234|NCT03975790|147363349|SUPERIORITY|||||||0.8376|||||||Chi-squared|||Cardiovascular Disease||||0.8376
73917235|NCT03975790|147363349|SUPERIORITY|||||||0.5927|||||||Chi-squared|||COPD||||0.5927
73917236|NCT03975790|147363349|SUPERIORITY|||||||0.5202|||||||Chi-squared|||COPD||||0.5202
73917237|NCT03975790|147363349|SUPERIORITY|||||||0.8517|||||||Chi-squared|||COPD||||0.8517
73917238|NCT03975790|147363349|SUPERIORITY|||||||8.33|||||||Chi-squared|||Asthma||||8.33
73917239|NCT03975790|147363349|SUPERIORITY|||||||0.7483|||||||Chi-squared|||Asthma||||0.7483
73917240|NCT03975790|147363349|SUPERIORITY|||||||0.9713|||||||Chi-squared|||Asthma||||0.9713
73917241|NCT03975790|147363349|SUPERIORITY|||||||0.9148|||||||Chi-squared|||Kidney disease||||0.9148
73917242|NCT03975790|147363349|SUPERIORITY|||||||0.7248|||||||Chi-squared|||Kidney disease||||0.7248
73917243|NCT03975790|147363349|SUPERIORITY|||||||0.82|||||||Chi-squared|||Kidney disease||||0.8200
73966556|NCT04093752|147469518|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% noninferiority (NI) boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common standard deviation (SD) of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.49|||||TWO_SIDED|95.0|-1.69|-1.29||||||||-1.29|-1.69|
73966557|NCT04093752|147469518|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.54|||||TWO_SIDED|95.0|-1.74|-1.34||||||||-1.34|-1.74|
73966558|NCT04093752|147469519|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.29|||||TWO_SIDED|95.0|-1.49|-1.09||||||||-1.09|-1.49|
73966559|NCT04093752|147469520|SUPERIORITY||LS Mean Difference|-6.5|||<|0.001|TWO_SIDED|95.0|-7.4|-5.6|||Mixed Models Analysis|||||-5.6|-7.4|<0.001
73966560|NCT04093752|147469520|SUPERIORITY||LS Mean Difference|-8.5|||<|0.001|TWO_SIDED|95.0|-9.5|-7.6|||Mixed Models Analysis|||||-7.6|-9.5|<0.001
73966561|NCT04093752|147469520|SUPERIORITY||LS Mean Difference|-8.7|||<|0.001|TWO_SIDED|95.0|-9.6|-7.7|||Mixed Models Analysis|||||-7.7|-9.6|<0.001
73966562|NCT04093752|147469521|SUPERIORITY||Odds Ratio (OR)|14.54|||<|0.001|TWO_SIDED|95.0|8.94|23.64|||Regression, Logistic|||||23.64|8.94|<0.001
73966563|NCT04093752|147469521|SUPERIORITY||Odds Ratio (OR)|28.76|||<|0.001|TWO_SIDED|95.0|16.72|49.49|||Regression, Logistic|||||49.49|16.72|<0.001
73966564|NCT04093752|147469521|SUPERIORITY||Odds Ratio (OR)|25.27|||<|0.001|TWO_SIDED|95.0|14.88|42.95|||Regression, Logistic|||||42.95|14.88|<0.001
73966565|NCT04093752|147469522|SUPERIORITY||Odds Ratio (OR)|82.54||||0.002|TWO_SIDED|95.0|5.13|1327.81|||Regression, Logistic|||||1327.81|5.13|0.002
73966566|NCT04093752|147469522|SUPERIORITY||Odds Ratio (OR)|124.76|||<|0.001|TWO_SIDED|95.0|7.79|1997.01|||Regression, Logistic|||||1997.01|7.79|<0.001
73966567|NCT04093752|147469522|SUPERIORITY||Odds Ratio (OR)|184.9|||<|0.001|TWO_SIDED|95.0|11.59|2950.73|||Regression, Logistic|||||2950.73|11.59|<0.001
73966568|NCT04093752|147469523|SUPERIORITY||LS Mean Difference|-12.3|||<|0.001|TWO_SIDED|95.0|-18.3|-6.3|||Mixed Models Analysis|||||-6.3|-18.3|<0.001
73966569|NCT04093752|147469523|SUPERIORITY||LS Mean Difference|-20.0|||<|0.001|TWO_SIDED|95.0|-26.1|-13.9|||Mixed Models Analysis|||||-13.9|-26.1|<0.001
73966570|NCT04093752|147469523|SUPERIORITY||LS Mean Difference|-18.6|||<|0.001|TWO_SIDED|95.0|-24.6|-12.5|||Mixed Models Analysis|||||-12.5|-24.6|<0.001
73966571|NCT04093752|147469524|SUPERIORITY||LS Mean Difference|-34.2|||<|0.001|TWO_SIDED|95.0|-40.1|-28.3|||Mixed Models Analysis|||||-28.3|-40.1|<0.001
73966572|NCT04093752|147469524|SUPERIORITY||LS Mean Difference|-40.6|||<|0.001|TWO_SIDED|95.0|-46.7|-34.6|||Mixed Models Analysis|||||-34.6|-46.7|<0.001
73966573|NCT04093752|147469524|SUPERIORITY||LS Mean Difference|-41.8|||<|0.001|TWO_SIDED|95.0|-47.9|-35.8|||Mixed Models Analysis|||||-35.8|-47.9|<0.001
73966574|NCT04093752|147469525|SUPERIORITY||Odds Ratio (OR)|21.89|||<|0.001|TWO_SIDED|95.0|11.63|41.2|||Regression, Logistic|||||41.20|11.63|<0.001
73917244|NCT03975790|147363349|SUPERIORITY|||||||0.9657|||||||Chi-squared|||Diabetes||||0.9657
73917245|NCT03975790|147363349|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Diabetes||||0.9255
73917246|NCT03975790|147363349|SUPERIORITY|||||||0.9575|||||||Chi-squared|||Diabetes||||0.9575
73917247|NCT03975790|147363349|SUPERIORITY|||||||0.941|||||||Chi-squared|||Depression||||0.9410
73917248|NCT03975790|147363349|SUPERIORITY|||||||0.9146|||||||Chi-squared|||Depression||||0.9146
73917249|NCT03975790|147363349|SUPERIORITY|||||||0.9641|||||||Chi-squared|||Depression||||0.9641
73917250|NCT03975790|147363349|SUPERIORITY|||||||0.2596|||||||Chi-squared|||Anxiety||||0.2596
73966575|NCT04093752|147469525|SUPERIORITY||Odds Ratio (OR)|43.79|||<|0.001|TWO_SIDED|95.0|22.96|83.5|||Regression, Logistic|||||83.50|22.96|<0.001
73966576|NCT04093752|147469525|SUPERIORITY||Odds Ratio (OR)|48.41|||<|0.001|TWO_SIDED|95.0|25.34|92.49|||Regression, Logistic|||||92.49|25.34|<0.001
73966577|NCT04093752|147469526|SUPERIORITY||LS Mean Difference|-0.47||||0.007|TWO_SIDED|95.0|-0.81|-0.13|||ANCOVA|||Hyperglycemia||-0.13|-0.81|0.007
73966578|NCT04093752|147469526|SUPERIORITY||LS Mean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.11|-0.43|||ANCOVA|||Hyperglycemia||-0.43|-1.11|<0.001
73966579|NCT04093752|147469526|SUPERIORITY||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-1.05|-0.36|||ANCOVA|||Hyperglycemia||-0.36|-1.05|<0.001
73966580|NCT04093752|147469526|SUPERIORITY||LS Mean Difference|-0.14||||0.384|TWO_SIDED|95.0|-0.46|0.18|||ANCOVA|||Hypoglycemia||0.18|-0.46|0.384
73966581|NCT04093752|147469526|SUPERIORITY||LS Mean Difference|-0.17||||0.307|TWO_SIDED|95.0|-0.49|0.16|||ANCOVA|||Hypoglycemia||0.16|-0.49|0.307
73966582|NCT04093752|147469526|SUPERIORITY||LS Mean Difference|-0.22||||0.184|TWO_SIDED|95.0|-0.55|0.11|||ANCOVA|||Hypoglycemia||0.11|-0.55|0.184
73966583|NCT04093752|147469526|SUPERIORITY||LS Mean Difference|1.81|||<|0.001|TWO_SIDED|95.0|1.03|2.59|||ANCOVA|||Treatment Satisfaction Score||2.59|1.03|<0.001
73966584|NCT04093752|147469526|SUPERIORITY||LS Mean Difference|1.63|||<|0.001|TWO_SIDED|95.0|0.84|2.41|||ANCOVA|||Treatment Satisfaction Score||2.41|0.84|<0.001
73966585|NCT04093752|147469526|SUPERIORITY||LS Mean Difference|1.68|||<|0.001|TWO_SIDED|95.0|0.89|2.47|||ANCOVA|||Treatment Satisfaction Score||2.47|0.89|<0.001
73966586|NCT00593489|147469562|SUPERIORITY||Risk Ratio (RR)|0.99||||0.96|TWO_SIDED|95.0|0.8|1.24|||Poisson Regression|||The IPR was analyzed using Poisson regression with the intervention group as a class effect and the mean HbA1c at baseline as a covariate||1.24|0.8|0.96
73966587|NCT02742519|147469573|SUPERIORITY|||||||0.2121|||||||t-test, 2 sided|||||||0.2121
73966588|NCT03580369|147469595|SUPERIORITY||LS Mean|-8.002|STANDARD_ERROR_OF_MEAN|1.313|<|0.0001|TWO_SIDED|95.0|-10.576|-5.428|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||-5.428|-10.576|<.0001
74027626|NCT03114969|147608611|SUPERIORITY||Odds Ratio (OR)|3.896|||<|0.001|TWO_SIDED|95.0|2.133|7.118||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||7.118|2.133|<0.001
73917251|NCT03975790|147363349|SUPERIORITY|||||||0.2228|||||||Chi-squared|||Anxiety||||0.2228
73917252|NCT03975790|147363349|SUPERIORITY|||||||0.7824|||||||Chi-squared|||Anxiety||||0.7824
73917253|NCT03975790|147363349|SUPERIORITY|||||||0.4184|||||||Chi-squared|||Liver disease||||0.4184
73917254|NCT03975790|147363349|SUPERIORITY|||||||0.4371|||||||Chi-squared|||Liver disease||||0.4371
73917255|NCT03975790|147363349|SUPERIORITY|||||||0.2074|||||||Chi-squared|||Liver disease||||0.2074
73917256|NCT03975790|147363349|SUPERIORITY|||||||0.785|||||||Chi-squared|||Sleep disorders||||0.7850
73917257|NCT03975790|147363349|SUPERIORITY|||||||0.1288|||||||Chi-squared|||Sleep disorders||||0.1288
73917258|NCT03975790|147363349|SUPERIORITY|||||||0.2839|||||||Chi-squared|||Sleep disorders||||0.2839
73917259|NCT03975790|147363350|SUPERIORITY|||||||0.2242|||||||Chi-squared|||||||0.2242
73917260|NCT03975790|147363350|SUPERIORITY|||||||0.0014|||||||Chi-squared|||||||0.0014
73917261|NCT03975790|147363350|SUPERIORITY|||||||0.0557|||||||Chi-squared|||||||0.0557
73917262|NCT03975790|147363351|SUPERIORITY|||||||0.5944|||||||Chi-squared|||Switch immediately||||0.5944
73917263|NCT03975790|147363351|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Switch immediately||||0.9255
73917264|NCT03975790|147363351|SUPERIORITY|||||||0.7824|||||||Chi-squared|||Switch immediately||||0.7824
74086366|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.572||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Phonemic fluency||||0.572
73917265|NCT03975790|147363351|SUPERIORITY|||||||0.3975|||||||Chi-squared|||Discontinue then switch||||0.3975
73917266|NCT03975790|147363351|SUPERIORITY|||||||0.0552|||||||Chi-squared|||Discontinue then switch||||0.0552
73917267|NCT03975790|147363351|SUPERIORITY|||||||0.3914|||||||Chi-squared|||Discontinue then switch||||0.3914
73917268|NCT03975790|147363351|SUPERIORITY|||||||0.2036|||||||Chi-squared|||Discontinue then restart||||0.2036
73917269|NCT03975790|147363351|SUPERIORITY|||||||0.1336|||||||Chi-squared|||Discontinue then restart||||0.1336
74086367|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.632||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit span backward - Working memory||||0.632
73917270|NCT03975790|147363351|SUPERIORITY|||||||0.7095|||||||Chi-squared|||Discontinue then restart||||0.7095
73917271|NCT03975790|147363351|SUPERIORITY|||||||0.2241|||||||Chi-squared|||Discontinue without switch or restart||||0.2241
73917272|NCT03975790|147363351|SUPERIORITY|||||||0.0024|||||||Chi-squared|||Discontinue without switch or restart||||0.0024
73917273|NCT03975790|147363351|SUPERIORITY|||||||0.1204|||||||Chi-squared|||Discontinue without switch or restart||||0.1204
73917274|NCT03975790|147363352|SUPERIORITY|||||||0.8424|||||||Chi-squared|||||||0.8424
73917275|NCT03975790|147363352|SUPERIORITY|||||||0.3278|||||||Chi-squared|||||||0.3278
73917276|NCT03975790|147363352|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
73917277|NCT03975790|147363353|SUPERIORITY|||||||0.2036|||||||Chi-squared|||||||0.2036
73917278|NCT03975790|147363353|SUPERIORITY|||||||0.1336|||||||Chi-squared|||||||0.1336
73917279|NCT03975790|147363353|SUPERIORITY|||||||0.7095|||||||Chi-squared|||||||0.7095
73917280|NCT03975790|147363355|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<0.0001
73917281|NCT03975790|147363355|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<.0001
73917282|NCT03975790|147363355|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<.0001
73917283|NCT03975790|147363356|SUPERIORITY|||||||0.0309|||||||Chi-squared|||Leflunomide||||0.0309
73917284|NCT03975790|147363356|SUPERIORITY|||||||0.9978|||||||Chi-squared|||Leflunomide||||0.9978
73917285|NCT03975790|147363356|SUPERIORITY|||||||0.2629|||||||Chi-squared|||Leflunomide||||0.2629
73917286|NCT03975790|147363356|SUPERIORITY|||||||0.0225|||||||Chi-squared|||Sulfasalazine||||0.0225
73917287|NCT03975790|147363356|SUPERIORITY|||||||0.4456|||||||Chi-squared|||Sulfasalazine||||0.4456
73917288|NCT03975790|147363356|SUPERIORITY|||||||0.5065|||||||Chi-squared|||Sulfasalazine||||0.5065
73917289|NCT03975790|147363356|SUPERIORITY|||||||0.6617|||||||Chi-squared|||Hydroxychloroquine||||0.6617
73917290|NCT03975790|147363356|SUPERIORITY|||||||0.7309|||||||Chi-squared|||Hydroxychloroquine||||0.7309
73917291|NCT03975790|147363356|SUPERIORITY|||||||0.9861|||||||Chi-squared|||Hydroxychloroquine||||0.9861
73917292|NCT03975790|147363357|SUPERIORITY|||||||0.088|||||||Chi-squared|||||||0.0880
73917293|NCT03975790|147363357|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73917294|NCT03975790|147363357|SUPERIORITY|||||||0.0065|||||||Chi-squared|||||||0.0065
73917295|NCT03975790|147363358|SUPERIORITY|||||||0.5157|||||||Chi-squared|||||||0.5157
73917296|NCT03975790|147363358|SUPERIORITY|||||||0.1231|||||||Chi-squared|||||||0.1231
73917297|NCT03975790|147363358|SUPERIORITY|||||||0.2109|||||||Chi-squared|||||||0.2109
73917298|NCT03975790|147363359|SUPERIORITY|||||||0.8424|||||||Chi-squared|||||||0.8424
73917299|NCT03975790|147363359|SUPERIORITY|||||||0.3278|||||||Chi-squared|||||||0.3278
73917300|NCT03975790|147363359|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
73917301|NCT03975790|147363360|SUPERIORITY|||||||0.0654|||||||Chi-squared|||||||0.0654
73917302|NCT03975790|147363360|SUPERIORITY|||||||0.7315|||||||Chi-squared|||||||0.7315
73917303|NCT03975790|147363360|SUPERIORITY|||||||0.1897|||||||Chi-squared|||||||0.1897
73917304|NCT03975790|147363361|SUPERIORITY|||||||0.5146|||||||Chi-squared|||||||0.5146
73917305|NCT03975790|147363361|SUPERIORITY|||||||0.7121|||||||Chi-squared|||||||0.7121
73917306|NCT03975790|147363361|SUPERIORITY|||||||0.4434|||||||Chi-squared|||||||0.4434
73917307|NCT03975790|147363362|SUPERIORITY|||||||0.8966|||||||Chi-squared|||||||0.8966
73917308|NCT03975790|147363362|SUPERIORITY|||||||0.2105|||||||Chi-squared|||||||0.2105
73917309|NCT03975790|147363362|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
73860592|NCT03582813|147267125|SUPERIORITY||MIXREG Estimate|4.27|STANDARD_ERROR_OF_MEAN|1.61|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime;||||<.01
73860593|NCT03582813|147267126|SUPERIORITY||MIXREG Estimate|0.9|STANDARD_ERROR_OF_MEAN|0.42||0.031|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-esteem that would be maintained longitudinally||||.031
73860594|NCT03582813|147267127|SUPERIORITY||MIXREG Estimate|0.12|STANDARD_ERROR_OF_MEAN|0.04|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in coping mastery that would be maintained longitudinally||||<0.01
73860595|NCT03582813|147267128|SUPERIORITY||MIXREG Estimate|0.29|STANDARD_ERROR_OF_MEAN|0.13||0.03|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in perceived autonomy support that would be maintained longitudinally||||0.030
73860596|NCT03582813|147267129|SUPERIORITY||Odds Ratio (OR)|2.19||||0.046|TWO_SIDED|95.0|1.01|4.74|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of employment that would be maintained longitudinally||4.74|1.01|0.046
73860597|NCT03582813|147267130|SUPERIORITY||Odds Ratio (OR)|4.14|||<|0.01|TWO_SIDED|95.0|1.5|11.44|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of enrollment in educational classes that would be maintained longitudinally||11.44|1.50|<0.01
73917310|NCT03975790|147363364|SUPERIORITY|||||||0.361|||||||Chi-squared|||||||0.3610
73917311|NCT03975790|147363364|SUPERIORITY|||||||0.4519|||||||Chi-squared|||||||0.4519
73917312|NCT03975790|147363364|SUPERIORITY|||||||0.9612|||||||Chi-squared|||||||0.9612
73917313|NCT03975790|147363365|SUPERIORITY|||||||0.8135|||||||Chi-squared|||||||0.8135
73917314|NCT03975790|147363365|SUPERIORITY|||||||0.591|||||||Chi-squared|||||||0.5910
73917315|NCT03975790|147363365|SUPERIORITY|||||||0.7635|||||||Chi-squared|||||||0.7635
73917316|NCT03975790|147363366|SUPERIORITY|||||||0.597|||||||Chi-squared|||||||0.5970
73966589|NCT03580369|147469595|SUPERIORITY||LS mean|0.672|STANDARD_ERROR_OF_MEAN|0.939||0.7628|TWO_SIDED|95.0|-1.169|2.513|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||2.513|-1.169|0.7628
73860598|NCT02230683|147267136|SUPERIORITY_OR_OTHER||within group change|-1.14|STANDARD_DEVIATION|4.57||0.257|TWO_SIDED|95.0|-3.16|0.89|||Paired t-test||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||0.89|-3.16|0.257
73860599|NCT02230683|147267136|SUPERIORITY_OR_OTHER||within group change|1.9|STANDARD_DEVIATION|3.15||0.1174|TWO_SIDED|95.0|-0.52|4.32|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup||4.32|-0.52|0.1174
73860600|NCT02230683|147267136|SUPERIORITY_OR_OTHER||within group change|-3.67|STANDARD_DEVIATION|4.05||0.0025|TWO_SIDED|95.0|-5.88|-1.46|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup||-1.46|-5.88|0.0025
73860601|NCT02230683|147267137|SUPERIORITY_OR_OTHER||within group change|-0.22||||0.026|TWO_SIDED|95.0|-0.42|-0.03|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||-0.03|-0.42|0.026
73917317|NCT03975790|147363366|SUPERIORITY|||||||0.7055|||||||Chi-squared|||||||0.7055
73917318|NCT03975790|147363367|SUPERIORITY|||||||0.5435|||||||Chi-squared|||||||0.5435
73917319|NCT03975790|147363367|SUPERIORITY|||||||0.679|||||||Chi-squared|||||||0.6790
73917320|NCT03975790|147363367|SUPERIORITY|||||||0.9676|||||||Chi-squared|||||||0.9676
73917321|NCT03975790|147363368|SUPERIORITY|||||||0.8035|||||||Chi-squared|||||||0.8035
73917322|NCT03975790|147363368|SUPERIORITY|||||||0.4184|||||||Chi-squared|||||||0.4184
73917323|NCT03975790|147363368|SUPERIORITY|||||||0.395|||||||Chi-squared|||||||0.3950
73917324|NCT03975790|147363370|SUPERIORITY|||||||0.7871|||||||Chi-squared|||||||0.7871
73917325|NCT03975790|147363370|SUPERIORITY|||||||0.0722|||||||Chi-squared|||||||0.0722
73917326|NCT03975790|147363370|SUPERIORITY|||||||0.181|||||||Chi-squared|||||||0.1810
73917327|NCT03975790|147363371|SUPERIORITY|||||||0.1984|||||||Chi-squared|||||||0.1984
73917328|NCT03975790|147363371|SUPERIORITY|||||||0.2043|||||||Chi-squared|||||||0.2043
73917329|NCT03975790|147363371|SUPERIORITY|||||||0.0439|||||||Chi-squared|||||||0.0439
73917330|NCT03975790|147363372|SUPERIORITY|||||||0.1702|||||||Chi-squared|||||||0.1702
73917331|NCT03975790|147363372|SUPERIORITY|||||||0.5926|||||||Chi-squared|||||||0.5926
73917332|NCT03975790|147363372|SUPERIORITY|||||||0.3088|||||||Chi-squared|||||||0.3088
73917333|NCT03975790|147363373|SUPERIORITY|||||||0.9141|||||||Chi-squared|||||||0.9141
73917334|NCT03975790|147363373|SUPERIORITY|||||||0.7623|||||||Chi-squared|||||||0.7623
73917335|NCT03975790|147363373|SUPERIORITY|||||||0.8517|||||||Chi-squared|||||||0.8517
73917336|NCT03975790|147363374|SUPERIORITY|||||||0.1208|||||||Chi-squared|||||||0.1208
73917337|NCT03975790|147363374|SUPERIORITY|||||||0.0425|||||||Chi-squared|||||||0.0425
73917338|NCT03975790|147363374|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
73917339|NCT03975790|147363375|SUPERIORITY|||||||0.8698|||||||t-test|||||||0.8698
73917340|NCT03975790|147363375|SUPERIORITY|||||||0.7391|||||||t-test|||||||0.7391
73917341|NCT03975790|147363375|SUPERIORITY|||||||0.7043|||||||t-test|||||||0.7043
73917342|NCT03975790|147363376|SUPERIORITY|||||||0.0536|||||||t-test|||||||0.0536
73917343|NCT03975790|147363376|SUPERIORITY|||||||0.9313|||||||t-test|||||||0.9313
73917344|NCT03975790|147363376|SUPERIORITY|||||||0.374|||||||t-test|||||||0.3740
73917345|NCT03975790|147363377|SUPERIORITY|||||||0.6963|||||||t-test|||||||0.6963
73917346|NCT03975790|147363377|SUPERIORITY|||||||0.9816|||||||t-test|||||||0.9816
73917347|NCT03975790|147363377|SUPERIORITY|||||||0.8349|||||||t-test|||||||0.8349
73917348|NCT03975790|147363378|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
73917349|NCT03975790|147363378|SUPERIORITY|||||||0.9431|||||||t-test|||||||0.9431
73917350|NCT03975790|147363378|SUPERIORITY|||||||0.2964|||||||t-test|||||||0.2964
73917351|NCT03975790|147363379|SUPERIORITY|||||||0.2614|||||||t-test|||||||0.2614
73917352|NCT03975790|147363379|SUPERIORITY|||||||0.0014|||||||t-test|||||||0.0014
73917353|NCT03975790|147363379|SUPERIORITY|||||||0.0535|||||||t-test|||||||0.0535
73917354|NCT03975790|147363380|SUPERIORITY|||||||0.0051|||||||t-test|||1 months before index date||||0.0051
73917355|NCT03975790|147363380|SUPERIORITY|||||||0.3041|||||||t-test|||1 months before index date||||0.3041
73917356|NCT03975790|147363380|SUPERIORITY|||||||0.4432|||||||t-test|||1 months before index date||||0.4432
73917357|NCT03975790|147363380|SUPERIORITY|||||||0.8641|||||||t-test|||2 months before index date||||0.8641
73917358|NCT03975790|147363380|SUPERIORITY|||||||0.0435|||||||t-test|||2 months before index date||||0.0435
73966590|NCT03580369|147469595|SUPERIORITY||LS Mean|-7.964|STANDARD_ERROR_OF_MEAN|1.305|<|0.0001|TWO_SIDED|95.0|-10.522|-5.047|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||-5.047|-10.522|<.0001
73966591|NCT03580369|147469595|SUPERIORITY||LS mean|0.71|STANDARD_ERROR_OF_MEAN|0.933||0.7768|TWO_SIDED|95.0|-1.118|2.538|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||2.538|-1.118|0.7768
74086368|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.512||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition A||||0.512
74086369|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition B||||0.861
73917359|NCT03975790|147363380|SUPERIORITY|||||||0.153|||||||t-test|||2 months before index date||||0.1530
73917360|NCT03975790|147363380|SUPERIORITY|||||||0.1188|||||||t-test|||3 months before index date||||0.1188
73917361|NCT03975790|147363380|SUPERIORITY|||||||0.6807|||||||t-test|||3 months before index date||||0.6807
73917362|NCT03975790|147363380|SUPERIORITY|||||||0.1772|||||||t-test|||3 months before index date||||0.1772
73917363|NCT03975790|147363380|SUPERIORITY|||||||0.6104|||||||t-test|||4 months before index date||||0.6104
73917364|NCT03975790|147363380|SUPERIORITY|||||||0.9564|||||||t-test|||4 months before index date||||0.9564
73917365|NCT03975790|147363380|SUPERIORITY|||||||0.7688|||||||t-test|||4 months before index date||||0.7688
73917366|NCT03975790|147363380|SUPERIORITY|||||||0.5685|||||||t-test|||5 months before index date||||0.5685
73917367|NCT03975790|147363380|SUPERIORITY|||||||0.5122|||||||t-test|||5 months before index date||||0.5122
73917368|NCT03975790|147363380|SUPERIORITY|||||||0.4321|||||||t-test|||5 months before index date||||0.4321
73917369|NCT03975790|147363380|SUPERIORITY|||||||0.7892|||||||t-test|||6 months before index date||||0.7892
73917370|NCT03975790|147363380|SUPERIORITY|||||||0.2874|||||||t-test|||6 months before index date||||0.2874
73917371|NCT03975790|147363380|SUPERIORITY|||||||0.2662|||||||t-test|||6 months before index date||||0.2662
73917372|NCT03975790|147363380|SUPERIORITY|||||||0.3091|||||||t-test|||7 months before index date||||0.3091
73917373|NCT03975790|147363380|SUPERIORITY|||||||0.5783|||||||t-test|||7 months before index date||||0.5783
73917374|NCT03975790|147363380|SUPERIORITY|||||||0.4021|||||||t-test|||7 months before index date||||0.4021
73917375|NCT03975790|147363380|SUPERIORITY|||||||0.767|||||||t-test|||8 months before index date||||0.7670
73917376|NCT03975790|147363380|SUPERIORITY|||||||0.6978|||||||t-test|||8 months before index date||||0.6978
73917377|NCT03975790|147363380|SUPERIORITY|||||||0.6328|||||||t-test|||8 months before index date||||0.6328
73917378|NCT03975790|147363380|SUPERIORITY|||||||0.0541|||||||t-test|||9 months before index date||||0.0541
73917379|NCT03975790|147363380|SUPERIORITY|||||||0.6999|||||||t-test|||9 months before index date||||0.6999
73917380|NCT03975790|147363380|SUPERIORITY|||||||0.359|||||||t-test|||9 months before index date||||0.3590
73917381|NCT03975790|147363380|SUPERIORITY|||||||0.936|||||||t-test|||10 months before index date||||0.9360
73917382|NCT03975790|147363380|SUPERIORITY|||||||0.626|||||||t-test|||10 months before index date||||0.6260
73917383|NCT03975790|147363380|SUPERIORITY|||||||0.7797|||||||t-test|||10 months before index date||||0.7797
73917384|NCT03975790|147363380|SUPERIORITY|||||||0.0934|||||||t-test|||11 months before index date||||0.0934
73917385|NCT03975790|147363380|SUPERIORITY|||||||0.396|||||||t-test|||11 months before index date||||0.3960
73917386|NCT03975790|147363380|SUPERIORITY|||||||0.4292|||||||t-test|||11 months before index date||||0.4292
73917387|NCT03975790|147363380|SUPERIORITY|||||||0.854|||||||t-test|||12 months before index date||||0.8540
73917388|NCT03975790|147363380|SUPERIORITY|||||||0.96|||||||t-test|||12 months before index date||||0.9600
73917389|NCT03975790|147363380|SUPERIORITY|||||||0.9374|||||||t-test|||12 months before index date||||0.9374
73917390|NCT03975790|147363380|SUPERIORITY|||||||0.6674|||||||t-test|||1 month after index date||||0.6674
73917391|NCT03975790|147363380|SUPERIORITY|||||||0.0776|||||||t-test|||1 month after index date||||0.0776
73917392|NCT03975790|147363380|SUPERIORITY|||||||0.335|||||||t-test|||1 month after index date||||0.3350
73917393|NCT03975790|147363380|SUPERIORITY|||||||0.8461|||||||t-test|||2 month after index date||||0.8461
73917394|NCT03975790|147363380|SUPERIORITY|||||||0.8111|||||||t-test|||2 month after index date||||0.8111
73917395|NCT03975790|147363380|SUPERIORITY|||||||0.7267|||||||t-test|||2 month after index date||||0.7267
73917396|NCT03975790|147363380|SUPERIORITY|||||||0.2453|||||||t-test|||3 month after index date||||0.2453
73917397|NCT03975790|147363380|SUPERIORITY|||||||0.5889|||||||t-test|||3 month after index date||||0.5889
73917398|NCT03975790|147363380|SUPERIORITY|||||||0.4162|||||||t-test|||3 month after index date||||0.4162
73917399|NCT03975790|147363380|SUPERIORITY|||||||0.0307|||||||t-test|||4 month after index date||||0.0307
73917400|NCT03975790|147363380|SUPERIORITY|||||||0.1147|||||||t-test|||4 month after index date||||0.1147
73917401|NCT03975790|147363380|SUPERIORITY|||||||0.9481|||||||t-test|||4 month after index date||||0.9481
74086370|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.958||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Condition B/A||||0.958
74086371|NCT01546922|147726134|SUPERIORITY_OR_OTHER|||||||0.819||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Social cognition||||0.819
74086372|NCT02285634|147726150|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
74086373|NCT02285634|147726150|SUPERIORITY|||||||0.52|||||||Fisher Exact|||||||0.52
74086374|NCT02285634|147726150|SUPERIORITY|||||||0.93|||||||Fisher Exact|||||||0.93
74086375|NCT02285634|147726151|SUPERIORITY|||||||0.06|||||||Fisher Exact|||||||0.06
74086376|NCT02285634|147726151|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
74086377|NCT02285634|147726151|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
73860602|NCT02230683|147267137|SUPERIORITY_OR_OTHER||within group change|-0.46||||0.001|TWO_SIDED|95.0|-0.72|-0.21|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||-0.21|-0.72|0.001
73860603|NCT02230683|147267137|SUPERIORITY_OR_OTHER||within group change|-0.04||||0.72|TWO_SIDED|95.0|-0.26|0.18|||ANCOVA|||Statistical Analysis for the median change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||0.18|-0.26|0.72
73860604|NCT02230683|147267138|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-21.0||||0.105|TWO_SIDED|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||13|-60|0.105
74086378|NCT02285634|147726152|SUPERIORITY|||||||0.27|||||||Fisher Exact|||||||0.27
73917402|NCT03975790|147363380|SUPERIORITY|||||||0.4455|||||||t-test|||5 month after index date||||0.4455
73917403|NCT03975790|147363380|SUPERIORITY|||||||0.9445|||||||t-test|||5 month after index date||||0.9445
73917404|NCT03975790|147363380|SUPERIORITY|||||||0.6191|||||||t-test|||5 month after index date||||0.6191
73966592|NCT03580369|147469597|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|5.68|||<|0.0001|TWO_SIDED|95.0|2.667|12.095|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||12.095|2.667|<.0001
74086379|NCT02285634|147726152|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
74086380|NCT02285634|147726152|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.56
73860605|NCT02230683|147267138|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-52.5||||0.016|TWO_SIDED|95.0|-109.0|-6.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||-6|-109|0.016
73860606|NCT02230683|147267138|SUPERIORITY_OR_OTHER||Hodges-Lehmann|12.0||||0.839|TWO_SIDED|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||13|-60|0.839
74086381|NCT02285634|147726153|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
74086382|NCT02285634|147726153|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.10
74086383|NCT02285634|147726153|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
74086384|NCT03173170|147726177|OTHER||Mean ratio|1.0622|||||TWO_SIDED|90.0|0.9569|1.1792||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90 percent (%) confidence intervals (CIs).||1.1792|0.9569|
74086385|NCT03173170|147726178|OTHER||Mean ratio|1.4892|||||TWO_SIDED|90.0|1.3851|1.6012||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.6012|1.3851|
74086386|NCT04205162|147726192|OTHER|||||||0.331|||||||Wilcoxon (Mann-Whitney)|||Comparison of etafilcon A||||0.331
74086387|NCT04205162|147726192|OTHER|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||Comparison of verofilcon A||||0.122
74086388|NCT04205162|147726193|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Comparison of etafilcon A||||0.130
74086389|NCT04205162|147726193|OTHER|||||||0.924|||||||Wilcoxon (Mann-Whitney)|||Comparison of verofilcon A||||0.924
74086390|NCT01098110|147726196|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-11.29|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-15.42|-7.16||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-7.16|-15.42|<0.0001
74086391|NCT01098110|147726196|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.22|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-17.33|-9.12||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-9.12|-17.33|<0.0001
73860607|NCT02230683|147267139|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-4.0||||0.0084|TWO_SIDED|95.0|-7.0|0.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Alanine Aminotransferase (ALT) from Baseline to Day 28/EOT||0|-7|0.0084
73917405|NCT03975790|147363380|SUPERIORITY|||||||0.0805|||||||t-test|||6 month after index date||||0.0805
73917406|NCT03975790|147363380|SUPERIORITY|||||||0.7037|||||||t-test|||6 month after index date||||0.7037
73917407|NCT03975790|147363380|SUPERIORITY|||||||0.4288|||||||t-test|||6 month after index date||||0.4288
73917408|NCT03975790|147363380|SUPERIORITY|||||||0.3731|||||||t-test|||7 month after index date||||0.3731
73917409|NCT03975790|147363380|SUPERIORITY|||||||0.4803|||||||t-test|||7 month after index date||||0.4803
73917410|NCT03975790|147363380|SUPERIORITY|||||||0.5831|||||||t-test|||7 month after index date||||0.5831
73917411|NCT03975790|147363380|SUPERIORITY|||||||0.0944|||||||t-test|||8 month after index date||||0.0944
74086392|NCT01098110|147726197|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-3.47|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-4.8|-2.13|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID|||-2.13|-4.80|<0.0001
73917412|NCT03975790|147363380|SUPERIORITY|||||||0.88|||||||t-test|||8 month after index date||||0.8800
73917413|NCT03975790|147363380|SUPERIORITY|||||||0.4949|||||||t-test|||8 month after index date||||0.4949
73860608|NCT02230683|147267140|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-4.0||||0.0131|TWO_SIDED|95.0|-7.0|-1.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Aspartate Aminotransferase (AST) from Baseline to Day 28/EOT||-1|-7|0.0131
73860609|NCT02230683|147267141|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-772.0||||0.003|TWO_SIDED|95.0|-1188.0|-19.0|||Wilcoxon (Mann-Whitney)||The estimated value is the ratio for the difference from baseline.|Statistical Analysis for the median change in concentration of Caspase 3/7 Relative Light Units from baseline to Day 28/EOT||-19|-1188|0.003
73917414|NCT03975790|147363380|SUPERIORITY|||||||0.6373|||||||t-test|||9 month after index date||||0.6373
73860610|NCT00260065|147267142|SUPERIORITY_OR_OTHER||Percentage of Participants|33.0||||||95.0|24.2|43.5||||||||43.5|24.2|
73860611|NCT00260065|147267143|SUPERIORITY_OR_OTHER||Percentage of Participants|52.0||||||95.0|41.3|61.7||||||||61.7|41.3|
73917415|NCT03975790|147363380|SUPERIORITY|||||||0.0497|||||||t-test|||9 month after index date||||0.0497
73917416|NCT03975790|147363380|SUPERIORITY|||||||0.1695|||||||t-test|||9 month after index date||||0.1695
73917417|NCT03975790|147363380|SUPERIORITY|||||||0.6373|||||||t-test|||10 month after index date||||0.6373
73917418|NCT03975790|147363380|SUPERIORITY|||||||0.7866|||||||t-test|||10 month after index date||||0.7866
73917419|NCT03975790|147363380|SUPERIORITY|||||||0.7643|||||||t-test|||10 months after index date||||0.7643
73917420|NCT03975790|147363380|SUPERIORITY|||||||0.2307|||||||t-test|||11 month after index date||||0.2307
73917421|NCT03975790|147363380|SUPERIORITY|||||||0.6712|||||||t-test|||11 month after index date||||0.6712
73917422|NCT03975790|147363380|SUPERIORITY|||||||0.6953|||||||t-test|||11 months after index date||||0.6953
73917423|NCT03975790|147363380|SUPERIORITY|||||||0.3675|||||||t-test|||12 month after index date||||0.3675
73917424|NCT03975790|147363380|SUPERIORITY|||||||0.8027|||||||t-test|||12 month after index date||||0.8027
73917425|NCT03975790|147363380|SUPERIORITY|||||||0.4817|||||||t-test|||12 month after index date||||0.4817
73917426|NCT03975790|147363381|SUPERIORITY|||||||0.0063|||||||t-test|||1 month before index date||||0.0063
73917427|NCT03975790|147363381|SUPERIORITY|||||||0.0162|||||||t-test|||1 month before index date||||0.0162
73917428|NCT03975790|147363381|SUPERIORITY|||||||0.8715|||||||t-test|||1 month before index date||||0.8715
73917429|NCT03975790|147363381|SUPERIORITY|||||||0.2799|||||||t-test|||2 months before index date||||0.2799
73917430|NCT03975790|147363381|SUPERIORITY|||||||0.0126|||||||t-test|||2 months before index date||||0.0126
73917431|NCT03975790|147363381|SUPERIORITY|||||||0.2126|||||||t-test|||2 months before index date||||0.2126
73917432|NCT03975790|147363381|SUPERIORITY|||||||0.7004|||||||t-test|||3 months before index date||||0.7004
73917433|NCT03975790|147363381|SUPERIORITY|||||||0.1476|||||||t-test|||3 months before index date||||0.1476
73917434|NCT03975790|147363381|SUPERIORITY|||||||0.2057|||||||t-test|||3 months before index date||||0.2057
73917435|NCT03975790|147363381|SUPERIORITY|||||||0.2905|||||||t-test|||4 months before index date||||0.2905
73917436|NCT03975790|147363381|SUPERIORITY|||||||0.8273|||||||t-test|||4 months before index date||||0.8273
73917437|NCT03975790|147363381|SUPERIORITY|||||||0.627|||||||t-test|||4 months before index date||||0.6270
73917438|NCT03975790|147363381|SUPERIORITY|||||||0.3256|||||||t-test|||5 months before index date||||0.3256
73917439|NCT03975790|147363381|SUPERIORITY|||||||0.5631|||||||t-test|||5 months before index date||||0.5631
73917440|NCT03975790|147363381|SUPERIORITY|||||||0.4491|||||||t-test|||5 months before index date||||0.4491
73917441|NCT03975790|147363381|SUPERIORITY|||||||0.2009|||||||t-test|||6 months before index date||||0.2009
73917442|NCT03975790|147363381|SUPERIORITY|||||||0.3011|||||||t-test|||6 months before index date||||0.3011
73917443|NCT03975790|147363381|SUPERIORITY|||||||0.2065|||||||t-test|||6 months before index date||||0.2065
73917444|NCT03975790|147363381|SUPERIORITY|||||||0.6098|||||||t-test|||7 months before index date||||0.6098
73917445|NCT03975790|147363381|SUPERIORITY|||||||0.2586|||||||t-test|||7 months before index date||||0.2586
73917446|NCT03975790|147363381|SUPERIORITY|||||||0.4074|||||||t-test|||7 months before index date||||0.4074
73917447|NCT03975790|147363381|SUPERIORITY|||||||0.0345|||||||t-test|||8 months before index date||||0.0345
73917448|NCT03975790|147363381|SUPERIORITY|||||||0.4377|||||||t-test|||8 months before index date||||0.4377
73917449|NCT03975790|147363381|SUPERIORITY|||||||0.7191|||||||t-test|||8 months before index date||||0.7191
73917450|NCT03975790|147363381|SUPERIORITY|||||||0.0199|||||||t-test|||9 months before index date||||0.0199
73917451|NCT03975790|147363381|SUPERIORITY|||||||0.1032|||||||t-test|||9 months before index date||||0.1032
73917452|NCT03975790|147363381|SUPERIORITY|||||||0.904|||||||t-test|||9 months before index date||||0.9040
73917453|NCT03975790|147363381|SUPERIORITY|||||||0.0316|||||||t-test|||10 months before index date||||0.0316
73917454|NCT03975790|147363381|SUPERIORITY|||||||0.6748|||||||t-test|||10 months before index date||||0.6748
73917455|NCT03975790|147363381|SUPERIORITY|||||||0.2679|||||||t-test|||10 months before index date||||0.2679
73917456|NCT03975790|147363381|SUPERIORITY|||||||0.501|||||||t-test|||11 months before index date||||0.5010
73917457|NCT03975790|147363381|SUPERIORITY|||||||0.3228|||||||t-test|||11 months before index date||||0.3228
73917458|NCT03975790|147363381|SUPERIORITY|||||||0.7881|||||||t-test|||11 months before index date||||0.7881
73917459|NCT03975790|147363381|SUPERIORITY|||||||0.0876|||||||t-test|||12 months before index date||||0.0876
73917460|NCT03975790|147363381|SUPERIORITY|||||||0.1226|||||||t-test|||12 months before index date||||0.1226
73917461|NCT03975790|147363381|SUPERIORITY|||||||0.9753|||||||t-test|||12 months before index date||||0.9753
73917462|NCT03975790|147363381|SUPERIORITY|||||||0.0336|||||||t-test|||1 month after index date||||0.0336
73917463|NCT03975790|147363381|SUPERIORITY|||||||0.2551|||||||t-test|||1 month after index date||||0.2551
73917464|NCT03975790|147363381|SUPERIORITY|||||||0.6189|||||||t-test|||1 month after index date||||0.6189
73917465|NCT03975790|147363381|SUPERIORITY|||||||0.7051|||||||t-test|||2 months after index date||||0.7051
73917466|NCT03975790|147363381|SUPERIORITY|||||||0.9775|||||||t-test|||2 months after index date||||0.9775
73860612|NCT03397134|147267211|SUPERIORITY|All statistical tests will be 2-sided hypothesis tests performed at the 5% level of significance. All confidence intervals will be 2-sided 95% confidence intervals||||||0.043||||||The p-values must be ≤0.025 to allow for rejecting the null hypothesis for the representative dose.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||To evaluate the efficacy of 2 fixed doses (32 mg and 64 mg) of MIN-101 compared to placebo in improving the negative symptoms of schizophrenia as measured by the change from Baseline in the PANSS Marder negative symptoms factor score (NSFS) over 12 weeks of double-blind treatment. Approximation 501 eligible patients will be randomized in a 2:2:1:1 ratio at baseline to 1 of 4 treatment arms.||||0.043
74027627|NCT03114969|147608611|SUPERIORITY||Odds Ratio (OR)|4.777|||<|0.001|TWO_SIDED|95.0|2.508|9.1||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||9.100|2.508|<0.001
74027628|NCT03114969|147608612|SUPERIORITY||Odds Ratio (OR)|7.347||||0.176|TWO_SIDED|95.0|0.408|132.143||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||132.143|0.408|0.176
74027629|NCT03114969|147608612|SUPERIORITY||Odds Ratio (OR)|9.3||||0.128|TWO_SIDED|95.0|0.526|164.465||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||164.465|0.526|0.128
74027630|NCT03114969|147608612|SUPERIORITY||Odds Ratio (OR)|20.454||||0.038|TWO_SIDED|95.0|1.19|351.613||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||351.613|1.190|0.038
74027631|NCT03114969|147608612|SUPERIORITY||Odds Ratio (OR)|18.776||||0.041|TWO_SIDED|95.0|1.131|311.669||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||311.669|1.131|0.041
74027632|NCT03114969|147608612|SUPERIORITY||Odds Ratio (OR)|8.873||||0.141|TWO_SIDED|95.0|0.484|162.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||162.775|0.484|0.141
74027633|NCT03114969|147608612|SUPERIORITY||Odds Ratio (OR)|10.215||||0.126|TWO_SIDED|95.0|0.519|200.904||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||200.904|0.519|0.126
74027634|NCT03114969|147608612|SUPERIORITY||Odds Ratio (OR)|13.717||||0.082|TWO_SIDED|95.0|0.715|263.125||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||263.125|0.715|0.082
74027635|NCT03114969|147608612|SUPERIORITY||Odds Ratio (OR)|28.283||||0.024|TWO_SIDED|95.0|1.561|512.532||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||512.532|1.561|0.024
74086393|NCT01098110|147726197|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-5.11|-2.46|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID|||-2.46|-5.11|<0.0001
74086394|NCT01098110|147726198|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.47|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.53|-1.41|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-1.41|-3.53|<0.0001
74086395|NCT01098110|147726198|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.03|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-4.08|-1.97|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-1.97|-4.08|<0.0001
74086396|NCT01098110|147726199|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-5.46|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED|95.0|-7.56|-3.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-3.35|-7.56|<0.0001
73917467|NCT03975790|147363381|SUPERIORITY|||||||0.7643|||||||t-test|||2 months after index date||||0.7643
73917468|NCT03975790|147363381|SUPERIORITY|||||||0.2953|||||||t-test|||3 months after index date||||0.2953
73917469|NCT03975790|147363381|SUPERIORITY|||||||0.6257|||||||t-test|||3 months after index date||||0.6257
74086397|NCT01098110|147726199|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.53|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-8.62|-4.44||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-4.44|-8.62|<0.0001
74086398|NCT01098110|147726200|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-3.41|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.72|-2.09|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-2.09|-4.72|<0.0001
74086399|NCT01098110|147726200|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.66|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.97|-2.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-2.35|-4.97|<0.0001
74086400|NCT01098110|147726201|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.36|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-3.47|-1.26|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID|||-1.26|-3.47|<0.0001
74086401|NCT01098110|147726201|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-4.03|-1.84|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID|||-1.84|-4.03|<0.0001
73860613|NCT03397134|147267212|SUPERIORITY|All statistical tests will be 2-sided hypothesis tests performed at the 5% level of significance. All confidence intervals will be 2-sided 95% confidence intervals.||||||0.016||||||The p-values must be ≤0.025 to allow for rejecting the null hypothesis for the representative dose.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||The PSP involves four subscale domains: (a) socially useful activities, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behaviors. After each of these four areas is scored on an anchored Likert-type scale (0-5), raters are instructed to select a 10-point range within a 100-point scale, guided by the area scores assigned during assessment.||||0.016
73860614|NCT05257148|147267270|SUPERIORITY||Mean Difference (Final Values)|-9.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73860615|NCT03554772|147267287|SUPERIORITY||||||<|0.0001||||||p-value for each dose group vs placebo comparison|ANCOVA|ANCOVA model included treatment as main effect , baseline NPRS and basline BMI as covariates P-value is Dunnett adjusted (individual treatment arms)||||||<0.0001
73917470|NCT03975790|147363381|SUPERIORITY|||||||0.4753|||||||t-test|||3 months after index date||||0.4753
73917471|NCT03975790|147363381|SUPERIORITY|||||||0.0926|||||||t-test|||4 months after index date||||0.0926
74086402|NCT01098110|147726202|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.72|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|-3.73|-1.7|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-1.70|-3.73|<0.0001
73860616|NCT03060512|147267304|OTHER|||||||0.9239|||||||Prescott's test|||Assessment of the difference in preference for the two treatments (Prefer Movantik, No Preference, Prefer PEG 3350) in subjects who completed the entire treatment sequence.||||0.9239
73917472|NCT03975790|147363381|SUPERIORITY|||||||0.0013|||||||t-test|||4 months after index date||||0.0013
73917473|NCT03975790|147363381|SUPERIORITY|||||||0.0065|||||||t-test|||4 months after index date||||0.0065
73917474|NCT03975790|147363381|SUPERIORITY|||||||0.2212|||||||t-test|||5 months after index date||||0.2212
73917475|NCT03975790|147363381|SUPERIORITY|||||||0.9688|||||||t-test|||5 months after index date||||0.9688
73917476|NCT03975790|147363381|SUPERIORITY|||||||0.5647|||||||t-test|||5 months after index date||||0.5647
73917477|NCT03975790|147363381|SUPERIORITY|||||||0.0023|||||||t-test|||6 months after index date||||0.0023
73917478|NCT03975790|147363381|SUPERIORITY|||||||0.1142|||||||t-test|||6 months after index date||||0.1142
73917479|NCT03975790|147363381|SUPERIORITY|||||||0.3842|||||||t-test|||6 months after index date||||0.3842
73860617|NCT03060512|147267304|OTHER|||||||0.8874|||||||Prescott's test|||Assessment of the difference between preference for treatment in Period 1, preference for treatment in Period 2, no preference||||0.8874
73917480|NCT03975790|147363381|SUPERIORITY|||||||0.9097|||||||t-test|||7 months after index date||||0.9097
73917481|NCT03975790|147363381|SUPERIORITY|||||||0.3885|||||||t-test|||7 months after index date||||0.3885
73917482|NCT03975790|147363381|SUPERIORITY|||||||0.3834|||||||t-test|||7 months after index date||||0.3834
73917483|NCT03975790|147363381|SUPERIORITY|||||||0.3075|||||||t-test|||8 months after index date||||0.3075
73917484|NCT03975790|147363381|SUPERIORITY|||||||0.9075|||||||t-test|||8 months after index date||||0.9075
73917485|NCT03975790|147363381|SUPERIORITY|||||||0.5993|||||||t-test|||8 months after index date||||0.5993
73917486|NCT03975790|147363381|SUPERIORITY|||||||0.0775|||||||t-test|||9 months after index date||||0.0775
73917487|NCT03975790|147363381|SUPERIORITY|||||||0.1536|||||||t-test|||9 months after index date||||0.1536
73917488|NCT03975790|147363381|SUPERIORITY|||||||0.8553|||||||t-test|||9 months after index date||||0.8553
73917489|NCT03975790|147363381|SUPERIORITY|||||||0.6295|||||||t-test|||10 months after index date||||0.6295
73917490|NCT03975790|147363381|SUPERIORITY|||||||0.0551|||||||t-test|||10 months after index date||||0.0551
73917491|NCT03975790|147363381|SUPERIORITY|||||||0.2215|||||||t-test|||10 months after index date||||0.2215
73917492|NCT03975790|147363381|SUPERIORITY|||||||0.1948|||||||t-test|||11 months after index date||||0.1948
73917493|NCT03975790|147363381|SUPERIORITY|||||||0.6621|||||||t-test|||11 months after index date||||0.6621
73917494|NCT03975790|147363381|SUPERIORITY|||||||0.6629|||||||t-test|||11 months after index date||||0.6629
73917495|NCT03975790|147363381|SUPERIORITY|||||||0.5699|||||||t-test|||12 months after index date||||0.5699
73917496|NCT03975790|147363381|SUPERIORITY|||||||0.7105|||||||t-test|||12 months after index date||||0.7105
73917497|NCT03975790|147363381|SUPERIORITY|||||||0.5965|||||||t-test|||12 months after index date||||0.5965
73966593|NCT03580369|147469597|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.84||||0.843|TWO_SIDED|95.0|0.598|1.18|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.180|0.598|0.8430
74086403|NCT01098110|147726202|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.08|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.09|-2.08|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-2.08|-4.09|<0.0001
74086404|NCT01098110|147726203|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-1.62|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.41|-0.83|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.83|-2.41|<0.0001
74086405|NCT01098110|147726203|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.26|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.04|-1.47|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-1.47|-3.04|<0.0001
73860618|NCT03060512|147267307|OTHER||Least Squares (LS) Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.3|0.3||||||Analysis of variance (ANOVA) model assessing treatment difference in PGIC at Visits 3 and 5 between Movantik and PEG 3350 treatment. Adjustments were performed for treatment, period and sequence.||0.3|-0.3|
73966594|NCT03580369|147469597|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|5.734|||<|0.0001|TWO_SIDED|95.0|2.694|12.207|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||12.207|2.694|<.0001
73860619|NCT03060512|147267309|OTHER||LS Means difference|-0.9|STANDARD_ERROR_OF_MEAN|1.95|||TWO_SIDED|95.0|-4.7|3.0||||||Analysis of Covariance (ANCOVA) model assessing treatment difference in BFI change from baseline at Visits 3/5 between Movantik and PEG 3350. Adjustments were performed for for baseline BFI score, treatment, period and sequence.||3.0|-4.7|
73860620|NCT02370004|147267311|OTHER|||||||0.1|||||||t-test, 2 sided|||Paired T-tests were used to evaluate changes in spirometry results||||.10
73860621|NCT00241631|147267315|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
73860622|NCT00241631|147267316|SUPERIORITY||||||<|0.05||||||calculated|Mixed Models Analysis|||||||<0.05
73860623|NCT00241631|147267317|SUPERIORITY||||||<|0.05||||||calculated|Mixed Models Analysis|||||||<0.05
73860624|NCT00904618|147267319|SUPERIORITY_OR_OTHER|||||||0.0087||95.0|||||Fisher Exact|||The test applies to the number of participants improved.||||0.0087
73860625|NCT02370641|147267394|OTHER||Mean Difference (Final Values)|-4.0||||0.012|TWO_SIDED|||||p\<0.05 is defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Firmicutes abundance between urolithin excretors and non excretors||||0.012
73860626|NCT02370641|147267394|OTHER||Mean Difference (Final Values)|2.6||||0.009|TWO_SIDED|||||p\<0.05 was defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Proteobacteria abundance between urolithin excretors and non excretors||||0.009
73966595|NCT03580369|147469597|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio, log|0.848||||0.8312|TWO_SIDED|95.0|0.605|1.188|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.188|0.605|0.8312
73966596|NCT03580369|147469598|SUPERIORITY||LS Mean|-3.1|STANDARD_ERROR_OF_MEAN|0.597|<|0.0001|TWO_SIDED|95.0|-4.271|-1.929|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||-1.929|-4.271|<.0001
73966597|NCT03580369|147469598|SUPERIORITY||LS Mean|0.419|STANDARD_ERROR_OF_MEAN|0.428||0.8366|TWO_SIDED|95.0|-0.419|1.258|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||1.258|-0.419|0.8366
73966598|NCT03580369|147469598|SUPERIORITY|Adults|LS Mean|-3.13|STANDARD_ERROR_OF_MEAN|0.594|<|0.0001|TWO_SIDED|95.0|-4.295|-1.966|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||||-1.966|-4.295|<.0001
73966599|NCT03580369|147469598|SUPERIORITY||LS Mean|0.389|STANDARD_ERROR_OF_MEAN|0.425||0.8201|TWO_SIDED|95.0|-0.444|1.222|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||1.222|-0.444|0.8201
73966600|NCT03580369|147469600|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|2.747|||<|0.0001|TWO_SIDED|95.0|1.621|4.656|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||4.656|1.621|<.0001
73966601|NCT03580369|147469600|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.836||||0.8586|TWO_SIDED|95.0|0.603|1.159|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.159|0.603|0.8586
73966602|NCT03580369|147469600|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|3.261|||<|0.0001|TWO_SIDED|95.0|1.929|5.513|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||5.513|1.929|<.0001
73966603|NCT03580369|147469600|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.992||||0.519|TWO_SIDED|95.0|0.717|1.373|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.373|0.717|0.5190
73966604|NCT03580369|147469601|SUPERIORITY||Risk Ratio (RR)|1.323|||<|0.0001|TWO_SIDED|95.0|1.183|1.48|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.480|1.183|<.0001
73966605|NCT03580369|147469601|SUPERIORITY||Risk Ratio (RR)|0.975||||0.7469|TWO_SIDED|95.0|0.904|1.051|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.051|0.904|0.7469
73966606|NCT03580369|147469601|SUPERIORITY||Risk Ratio (RR)|1.376|||<|0.0001|TWO_SIDED|95.0|1.23|1.54|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.540|1.230|<.0001
73966607|NCT03580369|147469601|SUPERIORITY||Risk Ratio (RR)|1.014||||0.3586|TWO_SIDED|95.0|0.941|1.092|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.092|0.941|0.3586
73966608|NCT02119650|147469615|OTHER||Hazard Ratio (HR)|0.877||||0.7562|TWO_SIDED|80.0|0.509|1.51|||Log Rank|The 2-sided p-value was calculated based on the log-rank test and stratified by modified Glasgow Prognostic Score (mGPS).||||1.51|0.509|0.7562
73966609|NCT05141903|147469718|SUPERIORITY||||||<|0.0001||||||(Dose group \* Time)|Mixed Models Analysis|Dfn, Dfd = 11, 369 F Value = 24.31||Dose Group 2 B. infantis levels compared to control group (antibiotic only) with changes over time||||<0.0001
73966610|NCT05141903|147469718|SUPERIORITY||||||<|0.0001||||||Dose group \* Time|Mixed Models Analysis|Dfn, Dfd = 11, 370 F value = 14.87||Dose Group 3 B. infantis levels compared to control group (antibiotic only) with changes over time||||<0.0001
73966611|NCT05141903|147469718|SUPERIORITY||||||<|0.0001||||||Dose Group \* Time|Mixed Models Analysis|Dfn, Dfd = 11, 351 F value = 8.606||Dose Group 2 (with HMO) B. infantis levels compared to dose Group 3 (without HMO) with changes over time||||<0.0001
73860627|NCT02133664|147267406|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.57||0.05|TWO_SIDED|95.0|-2.03|4.32|||t-test, 2 sided|||With the initial sample size plan of 53 subjects, we expect an 80% power to detect a significant difference in PASAT score with a mean difference of 8.3 points between the treatment and placebo group.||4.32|-2.03|0.05
73860628|NCT03906656|147267413|SUPERIORITY||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|8.1||0.0002|TWO_SIDED|||||Adjusted p-values based on Holm-Bonferroni method. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided||Mean difference is for paired data (n=73). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).|H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0002
73860629|NCT03906656|147267413|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|9.7|<|1e-05|TWO_SIDED|||||Adjusted p-values based on Holm-Bonferroni method. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided||Mean difference is for paired data (n=77). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).|H0: the mean difference (C-Brace - Baseline) \<= 0.||||<0.00001
73860630|NCT03906656|147267413|SUPERIORITY||Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|6.3|<|1e-05|TWO_SIDED||||||t-test, 2 sided||Mean difference is for paired data (n=86). This explains the discrepancy between the mean difference and the difference between the Baseline and KAFO means (n=102 and n=86, respectively).|KAFO vs. Baseline -- H0: the mean difference (KAFO - Baseline) \<= 0.||||<0.00001
73860631|NCT03906656|147267414|SUPERIORITY||Mean Difference (Final Values)|7.05|STANDARD_DEVIATION|26.3||0.005|TWO_SIDED|||||P-value not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|63.6 degrees of freedom.||H0: the mean difference (C-Brace - KAFO) \<= 0||||0.005
73860632|NCT03906656|147267415|SUPERIORITY|P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|3.7||0.005|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|74.4 degrees of freedom||H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.005
73860633|NCT03906656|147267416|SUPERIORITY||Mean Difference (Final Values)|0.185|STANDARD_DEVIATION|53.6||0.583|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=1207.5, effect size r = 0.026, p=0.583.|||0.583
73860634|NCT03906656|147267417|SUPERIORITY||Mean Difference (Final Values)|1.28|STANDARD_DEVIATION|4.37||0.0078|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0. (SAI - Down)|Wilcoxon Signed Rank Test V=438, effect size r = 0.21, p=0.008|||0.0078
73917498|NCT00411645|147363396|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.902||||0.789|TWO_SIDED|95.0|0.424|1.92||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|||1.920|0.424|0.789
73860635|NCT03906656|147267418|SUPERIORITY||Mean Difference (Final Values)|-3.41|STANDARD_DEVIATION|17.0||0.002|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||||Wilcoxon Signed Rank Test V=267, effect size r = 0.32, p=0.002|||0.0020
73917499|NCT00411645|147363397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.721||||0.056|TWO_SIDED|95.0|0.515|1.008||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay||1.008|0.515|0.056
73917500|NCT00411645|147363397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.979||||0.904|TWO_SIDED|95.0|0.697|1.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay||1.375|0.697|0.904
73917501|NCT00411645|147363397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.838||||0.289|TWO_SIDED|95.0|0.606|1.161||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia or CMV DNA PCR assay||1.161|0.606|0.289
73966612|NCT03467542|147469738|OTHER||||||||||||||||||The total number evaluated, the percent, and the Clopper-Pearson two-sided 95% confidence limits on the percent.|||
73860636|NCT03906656|147267419|SUPERIORITY||Mean Difference (Final Values)|-1.11|STANDARD_DEVIATION|3.178||0.0023|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0. (Fear of falling - indoors)|Wilcoxon Signed Rank Test V=433, effect size r = 0.33, p=0.002|||0.0023
73860637|NCT03906656|147267419|SUPERIORITY||Mean Difference (Final Values)|-0.973|STANDARD_DEVIATION|3.43||0.0066|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||||Wilcoxon Signed Rank Test V=557.5, effect size r = 0.265, p=0.0066|||0.0066
73860638|NCT03906656|147267420|SUPERIORITY|||||||0.006||||||P-value not adjusted for multiple comparisons|McNemar|||Paired dataset. H0: The probability of fallers wearing C-Brace becoming non-fallers wearing KAFO is the same as the probability of non-fallers wearing C-Brace becoming fallers wearing KAFO.||||0.006
73860639|NCT03906656|147267421|SUPERIORITY||Mean Difference (Final Values)|2.82|STANDARD_DEVIATION|16.4||0.08|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=1325.5, effect size r = 0.181, p=0.08.|||0.08
73860640|NCT03906656|147267422|SUPERIORITY||Mean Difference (Final Values)|0.009|STANDARD_DEVIATION|0.184||0.151|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||Wilcoxon Signed Rank Test V=1124.5, effect size r = 0.125 p=0.151|H0: the median of the population differences (C-Brace - KAFO) \<= 0||||0.151
74027636|NCT03114969|147608612|SUPERIORITY||Odds Ratio (OR)|21.736||||0.038|TWO_SIDED|95.0|1.183|399.541||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||399.541|1.183|0.038
74027637|NCT03114969|147608612|SUPERIORITY||Odds Ratio (OR)|7.603||||0.188|TWO_SIDED|95.0|0.371|155.763||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||155.763|0.371|0.188
74027638|NCT03114969|147608613|SUPERIORITY||Odds Ratio (OR)|7.781||||0.147|TWO_SIDED|95.0|0.488|124.117||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||124.117|0.488|0.147
74027639|NCT03114969|147608613|SUPERIORITY||Odds Ratio (OR)|9.786||||0.12|TWO_SIDED|95.0|0.553|173.301||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||173.301|0.553|0.120
74027640|NCT03114969|147608614|SUPERIORITY||Odds Ratio (OR)|2.089||||0.395|TWO_SIDED|95.0|0.383|11.389||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||11.389|0.383|0.395
74027641|NCT03114969|147608614|SUPERIORITY||Odds Ratio (OR)|3.25||||0.166|TWO_SIDED|95.0|0.612|17.244||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.244|0.612|0.166
74027642|NCT03114969|147608614|SUPERIORITY||Odds Ratio (OR)|3.196||||0.175|TWO_SIDED|95.0|0.596|17.14||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.140|0.596|0.175
74027643|NCT03114969|147608614|SUPERIORITY||Odds Ratio (OR)|5.408||||0.042|TWO_SIDED|95.0|1.059|27.61||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||27.610|1.059|0.042
74027644|NCT03114969|147608615|SUPERIORITY||Odds Ratio (OR)|12.145||||0.09|TWO_SIDED|95.0|0.68|216.818||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||216.818|0.680|0.090
74027645|NCT03114969|147608615|SUPERIORITY||Odds Ratio (OR)|9.991||||0.13|TWO_SIDED|95.0|0.508|196.435||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||196.435|0.508|0.130
74027646|NCT03114969|147608616|SUPERIORITY||Odds Ratio (OR)|11.907||||0.079|TWO_SIDED|95.0|0.753|188.208||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||188.208|0.753|0.079
74027647|NCT03114969|147608616|SUPERIORITY||Odds Ratio (OR)|15.06||||0.063|TWO_SIDED|95.0|0.866|262.042||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||262.042|0.866|0.063
74027648|NCT03114969|147608617|SUPERIORITY||Odds Ratio (OR)|2.67||||0.239|TWO_SIDED|95.0|0.521|13.69||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||13.690|0.521|0.239
73860641|NCT03906656|147267423|SUPERIORITY|H0: the mean of the population differences (C-Brace - KAFO) \>= 0|Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|21.5||0.281|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|16.7 degrees of freedom||WLQ-25 - Physical||||0.281
73860642|NCT03906656|147267424|SUPERIORITY||Mean Difference (Final Values)|1.99|STANDARD_DEVIATION|5.18||0.00019|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|48.4 degrees of freedom||OPUS - Low Extremity Functional Status. H0: the mean difference (C-Brace - KAFO) \<= 0||||0.00019
73917502|NCT00411645|147363397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.891||||0.493|TWO_SIDED|95.0|0.64|1.239||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy||1.239|0.640|0.493
73917503|NCT00411645|147363398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.129|TWO_SIDED||||||Log Rank|||||||0.129
74027649|NCT03114969|147608617|SUPERIORITY||Odds Ratio (OR)|2.929||||0.2|TWO_SIDED|95.0|0.567|15.125||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||15.125|0.567|0.200
73917504|NCT00411645|147363398|SUPERIORITY_OR_OTHER_LEGACY||Adjusted hazard ratio|0.83||||0.13|TWO_SIDED|95.0|0.65|1.06||The p-value from Wald Chi-Square test for treatment effect.|Wald Chi-squared||Maribavir versus placebo; based on Cox's proportional hazards regression model: time = recipient CMV serostatus (R+ or R-) + transplant type (myeloablative or non-myeloablative/reduced intensity) + treatment.|||1.06|0.65|0.130
74027650|NCT03114969|147608617|SUPERIORITY||Odds Ratio (OR)|4.269||||0.078|TWO_SIDED|95.0|0.848|21.489||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||21.489|0.848|0.078
73860643|NCT03906656|147267425|SUPERIORITY||Mean Difference (Final Values)|3.19|STANDARD_DEVIATION|15.0||0.0226|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|22.1 degrees of freedom||Emotional well-being. H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0226
73860644|NCT03906656|147267425|SUPERIORITY||Mean Difference (Final Values)|6.79|STANDARD_DEVIATION|21.1||0.002|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|||Energy/Fatigue. H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0020
74086406|NCT01098110|147726204|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-1.41|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.04|-0.78|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.78|-2.04|<0.0001
74086407|NCT01098110|147726204|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.53|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.16|-0.91|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-0.91|-2.16|<0.0001
74086408|NCT01098110|147726205|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.6||||0.0001|TWO_SIDED|95.0|9.2|28.1||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID|||28.1|9.2|0.0001
74086409|NCT01098110|147726205|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||<|0.0001|TWO_SIDED|95.0|13.7|32.6||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID|||32.6|13.7|<0.0001
74086410|NCT01098110|147726206|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-0.52|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.75|-0.28|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.28|-0.75|<0.0001
74086411|NCT01098110|147726206|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.82|-0.36|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-0.36|-0.82|<0.0001
74086412|NCT01098110|147726207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.2|||<|0.0001|TWO_SIDED|95.0|12.0|32.4||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID|||32.4|12.0|<0.0001
74086413|NCT01098110|147726207|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.8|||<|0.0001|TWO_SIDED|95.0|18.9|38.8||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID|||38.8|18.9|<0.0001
74086414|NCT02147587|147726208|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.213|||||TWO_SIDED|80.0|1.033|1.424|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Week 4|Geometric Mean Fold Rise (GMFR) for Tofacitinib versus Placebo (Week 4)||1.424|1.033|
74086415|NCT02147587|147726209|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.03|||||TWO_SIDED|80.0|0.877|1.209|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Day 1|GMFR for Tofacitinib versus Placebo (Day 1)||1.209|0.877|
74086416|NCT02147587|147726209|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.093|||||TWO_SIDED|80.0|0.924|1.294|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Week 12|GMFR for Tofacitinib versus Placebo (Week 12)||1.294|0.924|
74086417|NCT02147587|147726210|SUPERIORITY_OR_OTHER||Ratio of GMT|1.063|||||TWO_SIDED|80.0|0.821|1.375|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Day 1|Geometric Mean Titer (GMT) for Tofacitinib versus Placebo (Day 1)||1.375|0.821|
73917505|NCT00411645|147363399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.542|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant||||0.542
73917506|NCT00411645|147363399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.637|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant||||0.637
73917507|NCT00411645|147363399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.825|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 12 months post-transplant||||0.825
73917508|NCT00411645|147363400|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.669||||0.022|TWO_SIDED|95.0|0.474|0.946||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay||0.946|0.474|0.022
73917509|NCT00411645|147363400|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.878||||0.468|TWO_SIDED|95.0|0.617|1.247||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay||1.247|0.617|0.468
73917510|NCT00411645|147363400|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.772||||0.125|TWO_SIDED|95.0|0.555|1.075||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay or CMV DNA PCR assay||1.075|0.555|0.125
73917511|NCT00411645|147363400|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.731||||0.069|TWO_SIDED|95.0|0.521|1.026||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy||1.026|0.521|0.069
73917512|NCT00411645|147363400|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.913||||0.86|TWO_SIDED|95.0|0.332|2.508||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of EC-confirmed disease||2.508|0.332|0.860
73917513|NCT00411645|147363401|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.835||||0.617|TWO_SIDED|95.0|0.411|1.693||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 12 months post-transplant||1.693|0.411|0.617
74027651|NCT03114969|147608617|SUPERIORITY||Odds Ratio (OR)|5.132||||0.046|TWO_SIDED|95.0|1.031|25.55||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||25.550|1.031|0.046
74027652|NCT03114969|147608618|SUPERIORITY||Odds Ratio (OR)|3.483||||0.02|TWO_SIDED|95.0|1.218|9.961||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||9.961|1.218|0.020
74027653|NCT03114969|147608618|SUPERIORITY||Odds Ratio (OR)|2.284||||0.143|TWO_SIDED|95.0|0.757|6.895||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.895|0.757|0.143
74027654|NCT03114969|147608618|SUPERIORITY||Odds Ratio (OR)|5.268||||0.006|TWO_SIDED|95.0|1.615|17.187||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.187|1.615|0.006
74027655|NCT03114969|147608618|SUPERIORITY||Odds Ratio (OR)|4.655||||0.009|TWO_SIDED|95.0|1.478|14.666||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||14.666|1.478|0.009
74027656|NCT03114969|147608618|SUPERIORITY||Odds Ratio (OR)|1.274||||0.679|TWO_SIDED|95.0|0.405|4.005||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.005|0.405|0.679
73917514|NCT00411645|147363402|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.048||||0.7808|TWO_SIDED|95.0|0.754|1.457||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant||1.457|0.754|0.7808
73917515|NCT00411645|147363402|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.068||||0.6946|TWO_SIDED|95.0|0.771|1.479||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant||1.479|0.771|0.6946
73917516|NCT00411645|147363403|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.186||||0.6304|TWO_SIDED|95.0|0.592|2.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant||2.375|0.592|0.6304
73966613|NCT02278562|147469741|SUPERIORITY|||||||0.37||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933. The Type I error probability associated with this test of this null hypothesis is 0.05.||||0.37
73966614|NCT02278562|147469741|SUPERIORITY|||||||0.955||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933.||||0.955
74027657|NCT03114969|147608618|SUPERIORITY||Odds Ratio (OR)|3.804||||0.01|TWO_SIDED|95.0|1.372|10.544||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||10.544|1.372|0.010
74086418|NCT02147587|147726210|SUPERIORITY_OR_OTHER||Ratio of GMT|1.251|||||TWO_SIDED|80.0|0.967|1.618|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Week 4|GMT for Tofacitinib versus Placebo (Week 4)||1.618|0.967|
73917517|NCT00411645|147363403|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.726||||0.1019|TWO_SIDED|95.0|0.495|1.066||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant||1.066|0.495|0.1019
73966615|NCT05387447|147469756|OTHER|||||||0.05|||||||Z score|||||||.05
73966616|NCT05387447|147469757|OTHER|||||||0.05|||||||Z score|||||||.05
73966617|NCT05387447|147469759|OTHER|||||||0.05|||||||Z score|||||||.05
73966618|NCT05387447|147469760|OTHER|||||||0.05|||||||Z score|||||||.05
74027658|NCT03114969|147608618|SUPERIORITY||Odds Ratio (OR)|2.555||||0.083|TWO_SIDED|95.0|0.886|7.369||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||7.369|0.886|0.083
74086419|NCT02147587|147726210|SUPERIORITY_OR_OTHER||Ratio of GMT|1.121|||||TWO_SIDED|80.0|0.862|1.459|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Week 12|GMT for Tofacitinib versus Placebo (Week 12)||1.459|0.862|
74086420|NCT02147587|147726211|SUPERIORITY_OR_OTHER||Difference in percentages|8.39|||||TWO_SIDED|80.0|-4.05|20.56|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Day 1)||20.56|-4.05|
73966619|NCT03391466|147469764|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted International Prognostic Index (IPI) as data collected on case report forms.|Hazard Ratio (HR)|0.398|||<|0.0001|TWO_SIDED|95.0|0.308|0.514||Stratified (randomization factors) log-rank p-value.|Log Rank|Stratified (randomization stratification factors) log-rank test.|Hazard ratio (95% confidence interval (CI)), stratified using randomization stratification factors.|||0.514|0.308|<0.0001
73966620|NCT03391466|147469765|SUPERIORITY|One-sided p-value based on CMH test, one-sided tailed test, stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Difference in ORR|33.1|||<|0.0001|TWO_SIDED|95.0|23.2|42.1||Stratified (randomization factor) CMH test p-value.|Cochran-Mantel-Haenszel|Stratified (randomization factor) CMH test.|Difference in ORR (95% CI)|||42.1|23.2|<0.0001
73966621|NCT03391466|147469766|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Hazard Ratio (HR)|0.726||||0.0168|TWO_SIDED|95.0|0.54|0.977||Stratified log-rank (randomization factor) p-value.|Log Rank|Stratified (randomization factor) log-rank test.|Hazard ratio (95% CI), stratified using randomization stratification factors.||The Rho family spending function with parameter (Rho = 6) was used to allocate alpha between the interim and primary OS analysis. Given that fewer than the anticipated 210 events were observed at the data cutoff date for the primary OS analysis (25 January 2023), the efficacy boundary for the primary OS analysis was recalculated using the Rho family spending function based on the actual observed event numbers (177 deaths) resulting in an efficacy boundary at 1-sided significance level of 0.0249.|0.977|0.540|0.0168
73966622|NCT03391466|147469767|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Hazard Ratio (HR)|0.736||||0.0695|TWO_SIDED|95.0|0.488|1.108||Stratified (randomization stratification factors) log-rank test.|Log Rank||Hazard ratio (95% CI), stratified using randomization stratification factors.|||1.108|0.488|0.0695
74086421|NCT02147587|147726211|SUPERIORITY_OR_OTHER||Difference in percentages|14.01|||||TWO_SIDED|80.0|1.57|26.03|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Week 4)||26.03|1.57|
73917518|NCT05048784|147363407|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for Cmax.|Ratio of geometric least squares means|1.009|||||TWO_SIDED|90.0|0.98|1.04|||||The geometric least squares mean ratios and confidence intervals (Cls) were obtained by taking the exponential of the corresponding differences and Cls on the natural-log (In) scale.|||1.040|0.980|
73917519|NCT05048784|147363408|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for AUClast.|Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.967|1.055|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.055|0.967|
73917520|NCT05048784|147363409|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for AUCinf.|Ratio of geometric least squares means|1.02|||||TWO_SIDED|90.0|0.977|1.065|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.065|0.977|
73917521|NCT05048784|147363411|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for Cmax.|Ratio of geometric least squares means|1.001|||||TWO_SIDED|90.0|0.836|1.199|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.199|0.836|
73917522|NCT05048784|147363412|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for AUClast.|Ratio of geometric least squares means|1.447|||||TWO_SIDED|90.0|1.2|1.745|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.745|1.200|
73917523|NCT05048784|147363413|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for AUCinf.|Ratio of geometric least squares means|1.484|||||TWO_SIDED|90.0|1.236|1.783|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.783|1.236|
73917524|NCT01750242|147363434|SUPERIORITY_OR_OTHER_LEGACY||% of leads|86.5|||||ONE_SIDED|95.0|73.7|||||||A 95% lower confidence bound was calculated on the percentage of leads where an overlap existed. A subject may have 1 or 2 leads included in the analysis.|||73.7|
73917525|NCT01750242|147363435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.5|STANDARD_DEVIATION|8.7|||TWO_SIDED|95.0|-26.5|-18.4||||||Summary statistics on the UPDRS III score. A higher score is more motor dysfunction.||-18.4|-26.5|
73917526|NCT04380116|147363450|SUPERIORITY|||||||0.366|||||||ANOVA|||||||.366
73917527|NCT01025752|147363459|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|0.07||||0.007|TWO_SIDED|95.0|-0.67|0.8||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.80) fell below the non-inferiority margin of 1.|post-treatment (12 weeks) time point||0.80|-0.67|0.007
73917528|NCT01025752|147363459|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.23|||<|0.0001|TWO_SIDED|95.0|-0.94|0.49||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.49) fell below the non-inferiority margin of 1.|3 month post-baseline time point||0.49|-0.94|<0.0001
73917529|NCT01025752|147363459|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.08||||0.004|TWO_SIDED|95.0|-0.86|0.71||The non-inferiority margin is 1.|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.71) fell below the non-inferiority margin of 1.|6 month post- baseline time point.||0.71|-0.86|0.004
73917530|NCT01025752|147363460|OTHER||Mean Difference (Final Values)|-0.33||||0.12|TWO_SIDED|95.0|-0.74|0.09|||Mixed Models Analysis|||Post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||0.09|-0.74|0.12
73917531|NCT01025752|147363460|OTHER||Mean Difference (Final Values)|-0.34||||0.2|TWO_SIDED|95.0|-0.87|0.18|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||0.18|-0.87|0.20
73917532|NCT01025752|147363460|OTHER||Mean Difference (Final Values)|-0.02||||0.93|TWO_SIDED|95.0|-0.57|0.52|||Mixed Models Analysis|||6 months post baseline time point. (Mean difference of IVR CBT- F2F CBT)||0.52|-0.57|0.93
73917533|NCT01025752|147363461|OTHER||Mean Difference (Final Values)|-0.5||||0.58|TWO_SIDED|95.0|-2.29|1.29|||Mixed Models Analysis|||post-treatment (12 weeks) time point||1.29|-2.29|0.58
73917534|NCT01025752|147363461|OTHER||Mean Difference (Final Values)|-1.53||||0.12|TWO_SIDED|95.0|-3.46|0.41|||Mixed Models Analysis|||3 months post-baseline time point||0.41|-3.46|0.12
73917535|NCT01025752|147363461|OTHER||Mean Difference (Final Values)|-0.61||||0.51|TWO_SIDED|95.0|-2.42|1.2|||Mixed Models Analysis|||6 months post-baseline time point||1.20|-2.42|0.51
73917536|NCT01025752|147363462|OTHER||Mean Difference (Final Values)|0.29||||0.83|TWO_SIDED|95.0|-2.3|2.87|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||2.87|-2.30|0.83
74086422|NCT02147587|147726211|SUPERIORITY_OR_OTHER||Difference in percentages|2.65|||||TWO_SIDED|80.0|-10.66|15.83|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Week 12)||15.83|-10.66|
73917537|NCT01025752|147363462|OTHER||Mean Difference (Final Values)|1.15||||0.42|TWO_SIDED|95.0|-1.68|3.98|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||3.98|-1.68|0.42
73917538|NCT01025752|147363462|OTHER||Mean Difference (Final Values)|-0.58||||0.68|TWO_SIDED|95.0|-3.4|2.24|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||2.24|-3.40|0.68
73917539|NCT01025752|147363463|OTHER||Mean Difference (Final Values)|1.25||||0.4|TWO_SIDED|95.0|-1.66|4.16|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||4.16|-1.66|0.40
73917540|NCT01025752|147363463|OTHER||Mean Difference (Final Values)|0.38||||0.81|TWO_SIDED|95.0|-2.82|3.58|||Mixed Models Analysis|||3 months post-baseline. (Mean difference of IVR CBT- F2F CBT)||3.58|-2.82|0.81
73917541|NCT01025752|147363463|OTHER||Mean Difference (Final Values)|2.43||||0.16|TWO_SIDED|95.0|-0.96|5.82|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||5.82|-0.96|0.16
74086423|NCT00263887|147726216|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|||The main effect ANCOVA model includes the change from baseline to endpoint as the dependent variable, treatment and center as fixed factors, change in logarithm of total lung volume and baseline measurement as covariates.||||0.049
73917542|NCT01025752|147363464|OTHER||Mean Difference (Final Values)|0.24||||0.85|TWO_SIDED|95.0|-2.32|2.8|||Mixed Models Analysis|||post-treatment (12 weeks time point). (Mean difference of IVR CBT- F2F CBT)||2.80|-2.32|0.85
73917543|NCT01025752|147363464|OTHER||Mean Difference (Final Values)|-1.27||||0.4|TWO_SIDED|95.0|-4.27|1.73|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.73|-4.27|0.40
73917544|NCT01025752|147363464|OTHER||Mean Difference (Final Values)|-0.74||||0.68|TWO_SIDED|95.0|-4.3|2.83|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||2.83|-4.30|0.68
73917545|NCT01025752|147363465|OTHER||Mean Difference (Final Values)|-0.94||||0.17|TWO_SIDED|95.0|-2.28|0.4|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||0.40|-2.28|0.17
74086424|NCT01028911|147726268|SUPERIORITY_OR_OTHER||Adjusted Geometric Means Ratio|128.4|||||TWO_SIDED|90.0|75.9|217.21||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.||217.21|75.90|
74086425|NCT01028911|147726269|SUPERIORITY_OR_OTHER||Adjusted Geometric Means Ratio|119.82|||||TWO_SIDED|90.0|75.9|189.16||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.||189.16|75.90|
74086426|NCT00530348|147726272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.2173|TWO_SIDED|95.0|0.4|1.23||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariates was used.||1.23|0.40|0.2173
74086427|NCT00530348|147726273|SUPERIORITY_OR_OTHER||Rate ratio|0.45|||<|0.0001|TWO_SIDED|95.0|0.32|0.63||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.63|0.32|<0.0001
74086428|NCT00530348|147726274|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.33|0.61|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation, covariate adjustment for geographic region, was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||0.61|0.33|<0.0001
74086429|NCT00530348|147726275|SUPERIORITY_OR_OTHER|||||||0.4188|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||||0.4188
74086430|NCT00530348|147726276|SUPERIORITY_OR_OTHER|||||||0.0115|||||||Wei-Lachin|||Change at Year 2: analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by MSFC. Each endpoint could only be formally tested if prior endpoint was significant.||||0.0115
74086431|NCT00530348|147726277|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and baseline T2 lesion volume was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||||0.3080
74086432|NCT04364763|147726278|SUPERIORITY|||||||0.0352||||||p-value is for Day 7|Mixed Models Analysis|||||||0.0352
74086433|NCT04364763|147726278|SUPERIORITY|||||||0.235||||||p-value is for Day 28|Mixed Models Analysis|||Comparison made for Day 7 and Day 28||||0.2350
74086434|NCT02020967|147726315|OTHER||Odds Ratio (OR)|7.34||||0.0196|TWO_SIDED|95.0|1.38|39.11|||Regression, Logistic|||Predictor variable: Lips enlargement||39.11|1.38|0.0196
74086435|NCT02578745|147726316|SUPERIORITY||Risk Ratio (RR)|1.67||||0.72|TWO_SIDED|95.0|0.42|6.67|||Chi-squared|||||6.67|.42|0.72
74086436|NCT02578745|147726317|SUPERIORITY||Risk Ratio (RR)|1.67||||0.72|TWO_SIDED|95.0|0.42|6.67|||Chi-squared|||||6.67|.42|0.72
73860645|NCT03906656|147267425|SUPERIORITY||Mean Difference (Final Values)|10.1|STANDARD_DEVIATION|29.528||0.0049|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||Health change. H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=649, effect size r = 0.285, p=0.00493|||0.0049
73860646|NCT03906656|147267425|SUPERIORITY||Mean Difference (Final Values)|12.6|STANDARD_DEVIATION|29.2||6.47e-05|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|37.35 degrees of freedom||Physical Functioning Score. H0: the mean difference (C-Brace - KAFO) \<= 0||||0.0000647
73860647|NCT03906656|147267426|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|0.843||0.301|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||Device. H0: the median of the population differences (C-Brace - KAFO) \<= 0|Wilcoxon Signed Rank Test V=1018.5, effect size r = 0.056, p=0.301|||0.301
73860648|NCT01945775|147267428|SUPERIORITY||Hazard Ratio, log|0.542|||<|0.0001|TWO_SIDED|95.0|0.413|0.711|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||0.711|0.413|<0.0001
73860649|NCT01945775|147267429|SUPERIORITY||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.93|8.83|||Cochran-Mantel-Haenszel|||p-value was based on stratified Cochran-Mantel-Haenszel method. Stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status.||8.83|2.93|<0.0001
73860650|NCT01945775|147267430|SUPERIORITY||Hazard Ratio (HR)|0.848||||0.1693|TWO_SIDED|95.0|0.67|1.073|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||1.073|0.670|0.1693
73860651|NCT01945775|147267438|SUPERIORITY||Mean Difference (Final Values)|8.4|||<|0.0001|TWO_SIDED|95.0|4.6|12.3|||Mixed Models Analysis|||Analysis was based on repeated measures mixed-effect model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate. Analysis was based on restricted maximum likelihood using unstructured covariance matrix.||12.3|4.6|<0.0001
73860652|NCT01945775|147267439|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.257|0.549|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||0.549|0.257|<0.0001
73860653|NCT01945775|147267440|SUPERIORITY||Hazard Ratio (HR)|0.392||||0.0053|TWO_SIDED|95.0|0.198|0.775|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system).||0.775|0.198|0.0053
73917546|NCT01025752|147363465|OTHER||Mean Difference (Final Values)|-0.12||||0.86|TWO_SIDED|95.0|-1.39|1.16|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.16|-1.39|0.86
73917547|NCT01025752|147363465|OTHER||Mean Difference (Final Values)|0.37||||0.64|TWO_SIDED|95.0|-1.22|1.97|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.97|-1.22|0.64
73917548|NCT04294472|147363474|SUPERIORITY|Cohort 1 vs Placebo||||||0.1866|||||||Log Rank|||||||0.1866
73917549|NCT04294472|147363474|SUPERIORITY|Cohort 2 vs Placebo||||||0.2627|||||||Log Rank|||||||0.2627
73917550|NCT04294472|147363475|SUPERIORITY|Cohort 1 vs Placebo||||||0.0639|||||||Log Rank|||||||0.0639
73860654|NCT02876328|147267441|SUPERIORITY||||||<|0.001||||||Each active group is compared to placebo using a 2-sided .0167 significance level.|Cochran-Mantel-Haenszel|Analyses are stratified by site.||Analysis applies to both adults and children.||||<.001
73860655|NCT00892606|147267444|SUPERIORITY|||||||0.0072|||||||ANOVA|||||||0.0072
73860656|NCT00892606|147267445|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
73860657|NCT00892606|147267446|SUPERIORITY|||||||0.0146|||||||ANOVA|||||||0.0146
73860658|NCT00334282|147267454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46||||1e-07||95.0|0.34|0.62||stratified log-rank test|Log Rank||The estimated value is the hazard ratio comparing pazopanib to placebo.|||0.62|0.34|.0000001
73860659|NCT01689350|147267472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.01|TWO_SIDED|95.0|1.76|14.14|||Chi-squared|||Null hypothesis: there is no difference between the control group and experimental group in terms of frequency of leucopenia.(α=0.05） Chi-square test was applied to test the difference. The Chi-square value was 10.08 and the P-value was 0.0015, which indicated that the null hypothesis could be rejected.||14.14|1.76|<0.01
73860660|NCT01689350|147267473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.05|TWO_SIDED|95.0|1.01|7.13|||Chi-squared|||||7.13|1.01|<0.05
73860661|NCT03840525|147267481|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics were conducted. No group comparisons were done due to the fact that this was a feasibility trial and not an efficacy trial. 80% was used as the benchmark for acceptability.|||
73917551|NCT04294472|147363475|SUPERIORITY|Cohort 2 vs Placebo||||||0.0508|||||||Log Rank|||||||0.0508
73917552|NCT02289417|147363504|SUPERIORITY||Stratified Difference|19.2||||0.0142|TWO_SIDED|95.0|3.4|33.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of oral (PO) corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.6|3.4|0.0142
73917553|NCT02289417|147363504|SUPERIORITY||Stratified Difference|7.7||||0.2689|TWO_SIDED|95.0|-6.9|22.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method|||22.0|-6.9|0.2689
74086437|NCT02578745|147726318|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
74086438|NCT02578745|147726319|SUPERIORITY||||||>|0.99|TWO_SIDED|95.0|||||Chi-squared|||||||>0.99
74086439|NCT02578745|147726320|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
73917554|NCT02289417|147363505|SUPERIORITY||Stratified Difference|14.6||||0.1224|TWO_SIDED|95.0|-3.6|31.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||31.5|-3.6|0.1224
73917555|NCT02289417|147363505|SUPERIORITY||Stratified Difference|19.4||||0.0401|TWO_SIDED|95.0|1.1|36.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||36.0|1.1|0.0401
73917556|NCT02289417|147363506|SUPERIORITY||Stratified Difference|5.2||||0.2472|TWO_SIDED|95.0|-5.7|16.7|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||16.7|-5.7|0.2472
73917557|NCT02289417|147363506|SUPERIORITY||Stratified Difference|3.1||||0.4628|TWO_SIDED|95.0|-7.5|14.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||14.6|-7.5|0.4628
73917558|NCT02289417|147363507|SUPERIORITY||Stratified Difference|32.0||||0.0005|TWO_SIDED|95.0|13.8|47.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||47.4|13.8|0.0005
73917559|NCT02289417|147363507|SUPERIORITY||Stratified Difference|3.7||||0.6878|TWO_SIDED|95.0|-14.4|21.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||21.5|-14.4|0.6878
73917560|NCT02289417|147363508|SUPERIORITY||Stratified Difference|11.5||||0.1388|TWO_SIDED|95.0|-4.1|26.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||26.1|-4.1|0.1388
73917561|NCT02289417|147363508|SUPERIORITY||Stratified Difference|13.5||||0.0788|TWO_SIDED|95.0|-1.6|27.7||Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Cochran-Mantel-Haenszel||Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||27.7|-1.6|0.0788
73917562|NCT02289417|147363509|SUPERIORITY||Stratified Difference|24.8||||0.0046|TWO_SIDED|95.0|7.5|40.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||40.1|7.5|0.0046
73917563|NCT02289417|147363509|SUPERIORITY||Stratified Difference|6.0||||0.4476||95.0|-9.8|21.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||21.6|-9.8|0.4476
73917564|NCT02289417|147363510|SUPERIORITY||Stratified Difference|16.7||||0.0755|TWO_SIDED|95.0|-1.4|33.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.5|-1.4|0.0755
73917565|NCT02289417|147363510|SUPERIORITY||Stratified Difference|19.8||||0.037|TWO_SIDED|95.0|1.5|36.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||36.4|1.5|0.0370
73917566|NCT02289417|147363511|SUPERIORITY||Stratified Difference|14.6||||0.1167|TWO_SIDED|95.0|-3.3|31.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||31.4|-3.3|0.1167
73917567|NCT02289417|147363511|SUPERIORITY||Stratified Difference|18.1||||0.0534|TWO_SIDED|95.0|-0.3|34.9|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||34.9|-0.3|0.0534
73917568|NCT02289417|147363512|SUPERIORITY||Stratified Difference|16.6||||0.0758|TWO_SIDED|95.0|-1.5|33.3|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.3|-1.5|0.0758
74086440|NCT02578745|147726321|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.50
74086441|NCT02663882|147726324|SUPERIORITY|||||||0.503||||||the a priori threshold for statistical significance was p\<0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.503
74086442|NCT02663882|147726325|SUPERIORITY|||||||0.765||||||the a priori threshold for statistical significance was p\<0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.765
73966623|NCT03391466|147469768|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.29|0.487||One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Log Rank|Stratified (randomization stratification factors) log-rank test.|Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.487|0.290|<0.0001
73966624|NCT03391466|147469769|SUPERIORITY||Hazard Ratio (HR)|0.422|||||TWO_SIDED|95.0|0.327|0.545|||||Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.545|0.327|
73966625|NCT03391466|147469770|SUPERIORITY||Hazard Ratio (HR)|0.506|||||TWO_SIDED|95.0|0.383|0.669|||||Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.669|0.383|
73966626|NCT03391466|147469772|SUPERIORITY||Mixed Model with Repeated Measures|18.1|||<|0.0001|TWO_SIDED|95.0|12.3|23.9||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||23.9|12.3|<0.0001
73966627|NCT03391466|147469772|SUPERIORITY||Mixed Model with Repeated Measures|9.8||||0.0124|TWO_SIDED|95.0|2.6|17.0||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||17.0|2.6|0.0124
74027659|NCT03114969|147608618|SUPERIORITY||Odds Ratio (OR)|5.93||||0.002|TWO_SIDED|95.0|1.89|18.611||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||18.611|1.890|0.002
74027660|NCT03114969|147608618|SUPERIORITY||Odds Ratio (OR)|4.929||||0.007|TWO_SIDED|95.0|1.556|15.612||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||15.612|1.556|0.007
74027661|NCT03114969|147608618|SUPERIORITY||Odds Ratio (OR)|1.208||||0.746|TWO_SIDED|95.0|0.385|3.788||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.788|0.385|0.746
74027662|NCT03114969|147608619|SUPERIORITY||Odds Ratio (OR)|1.502||||0.404|TWO_SIDED|95.0|0.578|3.905||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.905|0.578|0.404
73917569|NCT02289417|147363512|SUPERIORITY||Stratified Difference|32.5||||0.0004|TWO_SIDED|95.0|14.9|47.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||47.5|14.9|0.0004
73917570|NCT04786990|147363519|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
73966628|NCT03391466|147469772|SUPERIORITY||Mixed Model with Repeated Measures|4.4||||0.2655|TWO_SIDED|95.0|-3.3|12.0||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Month 9.||12.0|-3.3|0.2655
73966629|NCT03391466|147469773|SUPERIORITY||Mixed Model with Repeated Measures|13.1|||<|0.0001|TWO_SIDED|95.0|8.0|18.2||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||18.2|8.0|<0.0001
74027663|NCT03114969|147608619|SUPERIORITY||Odds Ratio (OR)|1.591||||0.33|TWO_SIDED|95.0|0.625|4.05||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.050|0.625|0.330
74027664|NCT03114969|147608620|SUPERIORITY||Odds Ratio (OR)|1.738||||0.189|TWO_SIDED|95.0|0.761|3.968||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.968|0.761|0.189
73917571|NCT04786990|147363519|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
73966630|NCT03391466|147469773|SUPERIORITY||Mixed Model with Repeated Measures|5.1||||0.1253|TWO_SIDED|95.0|-0.9|11.0||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||11.0|-0.9|0.1253
73917572|NCT04786990|147363520|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
73917573|NCT04786990|147363520|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
73917574|NCT04786990|147363522|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
73917575|NCT04786990|147363522|OTHER|||||||0.0002||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0002
73917576|NCT04786990|147363523|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
73917577|NCT04786990|147363523|OTHER||||||<|0.0001||||||The p-value generated for the comparison between time points for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed. There is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
73917578|NCT04786990|147363524|OTHER|||||||0.0685||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0685
73917579|NCT04786990|147363524|OTHER|||||||0.2575||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 8||||0.2575
73966631|NCT03391466|147469774|SUPERIORITY||Mixed Model with Repeated Measures|0.081||||0.0112|TWO_SIDED|95.0|0.024|0.138||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||0.138|0.024|0.0112
74027665|NCT03114969|147608620|SUPERIORITY||Odds Ratio (OR)|2.079||||0.086|TWO_SIDED|95.0|0.901|4.799||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.799|0.901|0.086
74086443|NCT02663882|147726326|SUPERIORITY|||||||0.717||||||the a priori threshold for statistical significance was p=0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.717
74086444|NCT02663882|147726327|SUPERIORITY|||||||0.302||||||the a priori threshold for statistical significance was p=0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.302
73917580|NCT04786990|147363525|OTHER|||||||0.0832||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0832
73917581|NCT04786990|147363525|OTHER|||||||0.3715||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.3715
73917582|NCT04786990|147363526|OTHER|||||||0.0042||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 4||||0.0042
73917583|NCT04786990|147363526|OTHER|||||||0.0019||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0019
73917584|NCT04786990|147363527|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 4||||<0.0001
73917585|NCT04786990|147363527|OTHER|||||||0.0025||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 8||||0.0025
73917586|NCT04786990|147363528|OTHER|||||||0.0161||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0161
73966632|NCT03391466|147469774|SUPERIORITY||Mixed Model with Repeated Measures|0.028||||0.3703|TWO_SIDED|95.0|-0.034|0.091||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||0.091|-0.034|0.3703
73966633|NCT03391466|147469775|SUPERIORITY||Mixed Model with Repeated Measures|13.7|||<|0.0001|TWO_SIDED|95.0|8.5|18.8||False Discovery Rate Methodology|Mixed Model with Repeated Measures|Mixed Model with Repeated Measures Differences in Change from Baseline.||Difference in mean change of scores from Baseline at Day 100.||18.8|8.5|<0.0001
74086445|NCT04458467|147726328|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||||||0.033
73917587|NCT04786990|147363528|OTHER|||||||0.0122||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0122
74086446|NCT04458467|147726329|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73860662|NCT03840525|147267482|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics was conducted to determine acceptability for both the qigong and sham qigong group. No between group comparisons were conducted. A benchmark of 80% was used to determine acceptability.|||
73860663|NCT03840525|147267483|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics were conducted to determine acceptability. Benchmark for acceptability was set at 80% of participant attending at least 70% of the classes.|||
73860664|NCT01370837|147267506|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Kruskal-Wallis|||Arm||||0.84
73860665|NCT01370837|147267506|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Kruskal-Wallis|||Foot||||0.76
73860666|NCT01370837|147267506|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Kruskal-Wallis|||Arm||||0.53
73860667|NCT01370837|147267506|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Kruskal-Wallis|||Foot||||0.07
73860668|NCT01370837|147267506|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||0.25
73860669|NCT01370837|147267506|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||0.27
73860670|NCT01370837|147267506|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||< 0.01
73917588|NCT04786990|147363529|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
73966634|NCT03391466|147469775|SUPERIORITY||Mixed Model with Repeated Measures|11.3||||0.0004|TWO_SIDED|95.0|5.4|17.1||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||17.1|5.4|0.0004
73917589|NCT04786990|147363529|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
73966635|NCT03391466|147469775|SUPERIORITY||Mixed Model with Repeated Measures|3.8||||0.2549|TWO_SIDED|95.0|-2.3|10.0||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|Mixed Model with Repeated Measures Differences in Change from Baseline.||Difference in mean change of scores from Baseline at Month 9.||10.0|-2.3|0.2549
73966636|NCT05919082|147469781|OTHER||Odds Ratio (OR)|1.4||||0.0438|TWO_SIDED|95.0|1.01|1.99|||Regression, Logistic||The odds ratio and p-value are obtained by logistic regression model, adjusted for baseline PGA. Wald CI was presented.|||1.99|1.01|0.0438
73860671|NCT04240093|147267507|SUPERIORITY|This is a pilot intervention trial and was not powered to detect statistical significance.|Beta coefficient|-0.46|STANDARD_ERROR_OF_MEAN|0.33||0.17|TWO_SIDED|95.0|-1.11|0.2||a priori alpha p\<0.05|Generalized estimating equations (GEE)|Generalized estimating equations (GEE) with a poisson distribution controlling for baseline values.||Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication doses in the past 30 days at follow-up.||0.20|-1.11|0.17
73860672|NCT04240093|147267508|SUPERIORITY|This pilot feasibility and acceptability study was not powered to detect a statistically significant effect.|Beta coefficient|-0.18|STANDARD_ERROR_OF_MEAN|1.48||0.9|TWO_SIDED|95.0|-3.09|2.72||a priori alpha p\<0.05|Generalized estimating equation (GEE)|Generalized estimating equations (GEE) with a Poisson distribution controlling for baseline values.||Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication-related visits in the past 30 days at follow-up.||2.72|-3.09|0.90
73860673|NCT04240093|147267509|SUPERIORITY|As a pilot feasibility and acceptability trial, this study was not powered to detect a statistically significant effect.|Beta coefficient|-4.71|STANDARD_ERROR_OF_MEAN|2.05||0.02|TWO_SIDED|95.0|-8.72|-0.7||A priori alpha p\<0.05|Generalized estimating equations (GEE)|Generalized estimating equation (GEE) modeling with a binomial distribution, controlling for baseline values.||Hypothesis: Fewer participants in the CoMBAT experimental arm will have a positive opioid toxicology screen at the 6-month follow-up compared to participants in the SOC control arm.||-0.70|-8.72|0.02
73860674|NCT02839902|147267513|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-17.147||||0.0004|TWO_SIDED|95.0|-26.344|-7.95|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-7.950|-26.344|0.0004
73860675|NCT02839902|147267513|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-9.774||||0.1141|TWO_SIDED|95.0|-21.986|2.439|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with triglycerides concentration in sd LDL fraction at Week 8 using an ANCOVA model.||2.439|-21.986|0.1141
73860676|NCT02839902|147267513|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-10.246||||0.0248|TWO_SIDED|95.0|-19.143|-1.349|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with free cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-1.349|-19.143|0.0248
73860677|NCT02839902|147267513|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-11.511||||0.0047|TWO_SIDED|95.0|-19.34|-3.682|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with phospholipid concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-3.682|-19.340|0.0047
73860678|NCT02839902|147267514|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|9.499||||0.1826|TWO_SIDED|95.0|-4.623|23.622|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with TG to cholesterol ratio in sd LDL fraction at Week 8 using an ANCOVA model.||23.622|-4.623|0.1826
73860679|NCT02839902|147267515|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|1.066||||0.004|TWO_SIDED|95.0|0.356|1.776|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by cholesterol using an ANCOVA model.||1.776|0.356|0.0040
73860680|NCT02839902|147267515|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|1.553||||0.4428|TWO_SIDED|95.0|-2.884|5.991|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by triglycerides using an ANCOVA model.||5.991|-2.884|0.4428
73917590|NCT04786990|147363530|OTHER|||||||0.0002||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0002
73917591|NCT04786990|147363530|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
73917592|NCT04786990|147363531|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
73917593|NCT04786990|147363531|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
73917594|NCT04786990|147363532|OTHER|||||||0.0005||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0005
73966637|NCT05919082|147469782|OTHER||Odds Ratio (OR)|1.5||||0.0108|TWO_SIDED|95.0|1.1|2.12|||Regression, Logistic||The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.|||2.12|1.10|0.0108
73860681|NCT02839902|147267515|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|0.76||||0.057|TWO_SIDED|95.0|-0.024|1.544|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by free cholesterol using an ANCOVA model.||1.544|-0.024|0.0570
73917595|NCT04786990|147363533|OTHER|||||||0.0005||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0005
73917596|NCT04786990|147363534|OTHER|||||||0.0016||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0016
73917597|NCT04786990|147363535|OTHER|||||||0.89||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.8900
73917598|NCT04786990|147363536|OTHER|||||||0.3269||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.3269
73917599|NCT04786990|147363537|OTHER|||||||0.5085||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.5085
73917600|NCT04786990|147363538|OTHER|||||||0.3484||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.3484
73966638|NCT05919082|147469783|OTHER||Odds Ratio (OR)|1.5||||0.0199|TWO_SIDED|95.0|1.07|2.19|||Regression, Logistic||The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.|||2.19|1.07|0.0199
74086447|NCT05070390|147726342|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|Geometric Mean Ratio (GMR)|1.23|||||TWO_SIDED|90.0|0.62|2.44|||||GMR and 90% confidence interval (CI) were estimated using a linear mixed effects model and referencing a t-distribution.|||2.44|0.62|
74086448|NCT05070390|147726343|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|1.63|||||TWO_SIDED|90.0|0.55|4.83|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||4.83|0.55|
74086449|NCT05070390|147726344|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|1.45|||||TWO_SIDED|90.0|0.7|2.99|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||2.99|0.70|
74086450|NCT05070390|147726347|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.41|1.62|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.62|0.41|
74086451|NCT05070390|147726348|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.92|||||TWO_SIDED|90.0|0.6|1.42|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.42|0.60|
74086452|NCT05070390|147726351|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.22|3.1|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||3.10|0.22|
74086453|NCT05070390|147726352|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.22|3.1|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||3.10|0.22|
74086454|NCT05070390|147726353|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.38|||||TWO_SIDED|90.0|0.13|1.13|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.13|0.13|
73917601|NCT04786990|147363539|OTHER|||||||0.4385||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.4385
73917602|NCT04786990|147363540|OTHER|||||||0.5073||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.5073
73917603|NCT04786990|147363541|OTHER|||||||0.9119||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.9119
73917604|NCT04786990|147363542|OTHER|||||||0.014||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0140
73917605|NCT04786990|147363543|OTHER|||||||0.1542||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.1542
73917606|NCT04786990|147363544|OTHER|||||||0.0086||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0086
73917607|NCT04786990|147363545|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
73917608|NCT04786990|147363545|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
73917609|NCT04786990|147363546|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
73917610|NCT04786990|147363546|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
73917611|NCT04786990|147363547|OTHER|||||||0.5582||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||"Week 4; Morning PR-ADHD-RS-5 Total score versus Evening PR-ADHD-RS-5 Total score"||||0.5582
73917612|NCT04786990|147363548|OTHER|||||||0.5061||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||"Week 8; Morning PR-ADHD-RS-5 Total score versus Evening PR-ADHD-RS-5 Total score"||||0.5061
73917613|NCT01782222|147363549|SUPERIORITY_OR_OTHER||Least Square Mean|0.04|STANDARD_ERROR_OF_MEAN|1.24||0.977|TWO_SIDED|95.0|-2.42|2.5|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.50|-2.42|0.977
74086455|NCT00479388|147726422|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|1.6||0.006||95.0|-7.7|-1.3|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline LDL-C-by-time and concomitant statin group-by-time interaction.||||-1.3|-7.7|0.006
73917614|NCT01782222|147363549|SUPERIORITY_OR_OTHER||Least Square Mean|-0.22|STANDARD_ERROR_OF_MEAN|1.21||0.859|TWO_SIDED|95.0|-2.61|2.18|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.18|-2.61|0.859
73917615|NCT01782222|147363550|SUPERIORITY_OR_OTHER||Least Square Mean|-7.29|STANDARD_ERROR_OF_MEAN|2.53||0.005|TWO_SIDED|95.0|-12.3|-2.28|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-2.28|-12.30|0.005
73917616|NCT01782222|147363550|SUPERIORITY_OR_OTHER||Least Square Mean|-6.06|STANDARD_ERROR_OF_MEAN|2.45||0.015|TWO_SIDED|95.0|-10.9|-1.21|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.21|-10.90|0.015
73917617|NCT01782222|147363551|SUPERIORITY_OR_OTHER||Least Square Mean|-3.2|STANDARD_ERROR_OF_MEAN|2.46||0.2|TWO_SIDED|95.0|-8.17|1.76|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||1.76|-8.17|0.200
73917618|NCT01782222|147363551|SUPERIORITY_OR_OTHER||Least Square Mean|-3.04|STANDARD_ERROR_OF_MEAN|2.55||0.239|TWO_SIDED|95.0|-8.19|2.1|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.10|-8.19|0.239
73917619|NCT01782222|147363552|SUPERIORITY_OR_OTHER||Least Square Mean|-2.09|STANDARD_ERROR_OF_MEAN|3.23||0.519|TWO_SIDED|95.0|-8.48|4.31|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||4.31|-8.48|0.519
73917620|NCT01782222|147363552|SUPERIORITY_OR_OTHER||Least Square Mean|-5.06|STANDARD_ERROR_OF_MEAN|3.15||0.111|TWO_SIDED|95.0|-11.29|1.17|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||1.17|-11.29|0.111
73917621|NCT01782222|147363553|SUPERIORITY_OR_OTHER||Least Square Mean|-3.62|STANDARD_ERROR_OF_MEAN|1.9||0.06|TWO_SIDED|95.0|-7.39|0.15|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||0.15|-7.39|0.060
73917622|NCT01782222|147363553|SUPERIORITY_OR_OTHER||Least Square Mean|-3.88|STANDARD_ERROR_OF_MEAN|1.8||0.034|TWO_SIDED|95.0|-7.46|-0.3|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||-0.30|-7.46|0.034
73917623|NCT01782222|147363554|SUPERIORITY_OR_OTHER||Least Square Mean|-0.38|STANDARD_ERROR_OF_MEAN|0.39||0.334|TWO_SIDED|95.0|-1.16|0.4|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||0.40|-1.16|0.334
73917624|NCT01782222|147363554|SUPERIORITY_OR_OTHER||Least Square Mean|0.02|STANDARD_ERROR_OF_MEAN|0.38||0.968|TWO_SIDED|95.0|-0.74|0.77|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||0.77|-0.74|0.968
73917625|NCT01782222|147363555|SUPERIORITY_OR_OTHER||Least Square Mean|0.16|STANDARD_ERROR_OF_MEAN|1.26||0.899|TWO_SIDED|95.0|-2.34|2.66|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.66|-2.34|0.899
73917626|NCT01782222|147363555|SUPERIORITY_OR_OTHER||Least Square Mean|-0.33|STANDARD_ERROR_OF_MEAN|1.19||0.785|TWO_SIDED|95.0|-2.68|2.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||2.03|-2.68|0.785
73917627|NCT01782222|147363556|SUPERIORITY_OR_OTHER||Least Square Mean|-4.96|STANDARD_ERROR_OF_MEAN|1.99||0.014|TWO_SIDED|95.0|-8.91|-1.01|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.01|-8.91|0.014
73917628|NCT01782222|147363556|SUPERIORITY_OR_OTHER||Least Square Mean|-4.83|STANDARD_ERROR_OF_MEAN|1.92||0.013|TWO_SIDED|95.0|-8.63|-1.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.03|-8.63|0.013
73917629|NCT01179568|147363611|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||<|0.05|TWO_SIDED|95.0|0.82|1.81|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants. With 10% of 440 target enrollment lost to follow-up we had a power of 76-83% to detect predicted between-group difference in response (CGT with PLA, 40%; CGT with CIT, 60%; CIT 40%; and PLA 20%)||1.81|0.82|<0.05
73917630|NCT01179568|147363611|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED|95.0|0.88|1.17|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs PLA with CGT at week 20 (aim 2) based on the intention-to-treat principle including all randomized participants.||1.17|0.88|<0.05
73917631|NCT01179568|147363611|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||<|0.05|TWO_SIDED|95.0|1.0|1.46|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs CIT at week 20 (aim 3) based on the intention-to-treat principle including all randomized participants.||1.46|1|<0.05
73917632|NCT01179568|147363612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|2.04||0.74|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||0.74
73917633|NCT01179568|147363613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|1.98||0.53|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||.53
73917634|NCT01179568|147363613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.37|STANDARD_ERROR_OF_MEAN|2.08|<|0.001|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||<.001
74086456|NCT00479388|147726423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|STANDARD_ERROR_OF_MEAN|1.2|<=|0.001||95.0|13.4|17.9|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline HDL-C-by-time and concomitant statin group-by-time interaction.||||17.9|13.4|<=0.001
73917635|NCT01179568|147363614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|1.57||0.59|TWO_SIDED|||||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||.59
73917636|NCT01179568|147363615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.44||0.4|TWO_SIDED||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.||||.40
73917637|NCT01179568|147363615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13|STANDARD_ERROR_OF_MEAN|1.46||0.005|TWO_SIDED||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.||||.005
73966639|NCT02140645|147469830|SUPERIORITY_OR_OTHER||C-statistics|0.624|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73966640|NCT02140645|147469831|SUPERIORITY_OR_OTHER||C-statistcs|0.597|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73917638|NCT01482884|147363629|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.8||||0.4062|TWO_SIDED|95.0|-13.0|22.5||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||The null hypothesis is that the proportion of participants responding on tralokinumab is less than or equal to the proportion of participants responding on placebo.||22.5|-13.0|0.4062
73917639|NCT01482884|147363630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.57||0.3937|TWO_SIDED|95.0|-1.63|0.65|||ANCOVA|Mayo score at baseline as a covariate, and treatment and glucocorticosteroid-refractory status as factors in the model.||||0.65|-1.63|0.3937
73917640|NCT01482884|147363631|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.1043|TWO_SIDED|95.0|-4.0|28.3||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||||28.3|-4.0|0.1043
73917641|NCT01482884|147363632|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.4||||0.0326|TWO_SIDED|95.0|0.7|24.1||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||||24.1|0.7|0.0326
73917642|NCT01482884|147363634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.33||0.449|TWO_SIDED|95.0|-0.41|0.91|||ANCOVA|Modified Riley score at baseline as a covariate, and treatment as factors in the model.||||0.91|-0.41|0.4490
73917643|NCT00580606|147363640|SUPERIORITY_OR_OTHER||Risk Difference (RD)|55.0|||<|0.001|TWO_SIDED|95.0|22.2|77.6||No adjustments were made to the p-value.|Barnard's Statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline OFC was compared using Barnard's Statistic with the null hypothesis that there was no difference between treatment groups.||77.6|22.2|<0.001
73966641|NCT02140645|147469832|SUPERIORITY_OR_OTHER||R-squared|0.0858|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73966642|NCT02140645|147469833|SUPERIORITY_OR_OTHER||C-statistics|0.623|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
74027666|NCT03114969|147608620|SUPERIORITY||Odds Ratio (OR)|1.95||||0.082|TWO_SIDED|95.0|0.918|4.142||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.142|0.918|0.082
74027667|NCT03114969|147608620|SUPERIORITY||Odds Ratio (OR)|2.415||||0.018|TWO_SIDED|95.0|1.161|5.024||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.024|1.161|0.018
74086457|NCT00479388|147726424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|||<=|0.001||95.0|-19.2|-11.7|||Repeated measures analysis|ANCOVA model based on Tukey's normalized ranks with term for treatment, gender, concomitant statin group and Tukey's normal score of baseline.||||-11.7|-19.2|<=0.001
74086458|NCT01955044|147726432|SUPERIORITY||Median Difference (Final Values)|1.23||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||DHA levels||||0.05
73860682|NCT02839902|147267515|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|0.838||||0.036|TWO_SIDED|95.0|0.057|1.62|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by phospholipid using an ANCOVA model.||1.620|0.057|0.0360
73860683|NCT00740714|147267533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|0.85|>|0.025|TWO_SIDED|97.5|-1.33|2.51||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 1200 mg/day arm compared to placebo group.||2.51|-1.33|>0.025
73917644|NCT01325584|147363656|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||.07
73917645|NCT01325584|147363658|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||.53
73917646|NCT01325584|147363659|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||.48
73917647|NCT00887978|147363660|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|10.0||||0.089|TWO_SIDED|95.0|-2.0|22.0|||non-parametric ANCOVA|||Using an allocation ratio of 1:1 between UT-15C SR and placebo, a fixed sample size of approximately 266 subjects would provide at least 90% power at a significance level of 0.05 (two-sided hypothesis) to detect a 30 meter between-treatment difference in the change from Baseline in distance traversed during the 6-Minute Walk, assuming a standard deviation of 75 meters. A total sample size of approximately 300 subjects was determined to account for discontinuations during the enrollment period.||22.0|-2.0|0.089
73966643|NCT02140645|147469834|SUPERIORITY_OR_OTHER||R-squared|0.1753|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73966644|NCT02140645|147469835|SUPERIORITY_OR_OTHER||C-statistics|0.699|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73917648|NCT00887978|147363661|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
73917649|NCT00887978|147363662|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) Estimate|0.0||||0.22|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum test|||||0.0|-1.0|0.22
73917650|NCT00887978|147363663|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) estimate|0.0||||0.43|TWO_SIDED|95.0|0.0|0.0||Imputation strategies were implemented for the 26 UT-15C subjects and 17 placebo subjects without values reported at Week 16.|Wilcoxon rank sum test|||||0.0|0.0|0.43
73917651|NCT00887978|147363665|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) estimate|0.0||||0.3|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon rank sum test|||||1.0|0.0|0.30
73917652|NCT00887978|147363668|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|14.0||||0.058|TWO_SIDED|95.0|0.0|28.0|||ANCOVA|||||28.0|0.0|0.058
73917653|NCT00887978|147363669|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|15.0||||0.054|TWO_SIDED|95.0|-1.0|29.0|||ANCOVA|||||29.0|-1.0|0.054
73917654|NCT00887978|147363671|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|4.0||||0.674|TWO_SIDED|95.0|-16.0|24.0|||ANCOVA|||||24.0|-16.0|0.674
73917655|NCT00887978|147363672|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|28.0||||0.059|TWO_SIDED|95.0|1.0|59.0|||ANCOVA|||||59.0|1.0|0.059
73917656|NCT00887978|147363673|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|10.0||||0.22|TWO_SIDED|95.0|-10.0|31.0|||ANCOVA|||||31.0|-10.0|0.22
73917657|NCT00887978|147363674|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|3.0||||0.99|TWO_SIDED|95.0|-23.0|28.0|||ANCOVA|||||28.0|-23.0|0.99
73917658|NCT00887978|147363675|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||0.84||95.0|-25.0|22.0|||ANCOVA|||||22.0|-25.0|0.84
73917659|NCT04216329|147363680|OTHER|||||||0.02|||||||Students t-test|||||||0.02
73917660|NCT04216329|147363680|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
73917661|NCT04216329|147363680|OTHER|||||||0.02|||||||Students t-test|||||||0.02
73917662|NCT04216329|147363680|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
73917663|NCT04216329|147363680|OTHER|||||||0.02|||||||Students t-test|||||||0.02
73917664|NCT04216329|147363680|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
73917665|NCT04216329|147363682|OTHER|||||||0.09|||||||Students t-test|||||||0.09
73917666|NCT04216329|147363682|OTHER|||||||0.09|||||||Students t-test|||||||0.09
73917667|NCT04216329|147363682|OTHER|||||||0.09|||||||Students t-test|||||||0.09
73917668|NCT05353985|147363693|SUPERIORITY||LS Mean Difference|0.017|||=|0.847|TWO_SIDED|95.0|-0.162|0.197||P-value was based on a MMRM analysis with treatment group, week, treatment-by-week interaction, \& the randomization stratification factors as fixed effects \& baseline CDSD GI symptom severity scores as covariates, and participant as a random effect.|MMRM|||||0.197|-0.162|=0.847
73917669|NCT05353985|147363694|SUPERIORITY||LS Mean Difference|-0.331|||<|0.001|TWO_SIDED|95.0|-0.481|-0.181||P-value was based on a ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline Vh:Cd as covariates.|ANCOVA|||||-0.181|-0.481|<0.001
73917670|NCT02700815|147363701|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.277||0.0303|TWO_SIDED|95.0|-1.15|-0.06|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.06|-1.15|0.0303
73917671|NCT02700815|147363701|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.197||0.2886|TWO_SIDED|95.0|-0.18|0.6|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||0.60|-0.18|0.2886
73917672|NCT02700815|147363701|SUPERIORITY||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|0.197||0.0003|TWO_SIDED|95.0|-1.1|-0.33|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.33|-1.10|0.0003
73966645|NCT02140645|147469836|SUPERIORITY_OR_OTHER||C-statistics|0.683|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73966646|NCT02140645|147469837|SUPERIORITY_OR_OTHER||C-statistics|0.757|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73966647|NCT02140645|147469838|SUPERIORITY_OR_OTHER||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73966648|NCT02140645|147469839|SUPERIORITY_OR_OTHER||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73966649|NCT02140645|147469840|SUPERIORITY_OR_OTHER||C-statistics|0.733|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73917673|NCT02700815|147363702|SUPERIORITY||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.221||0.0956|TWO_SIDED|95.0|-0.8|0.07|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between placebo and combination therapy diclofenac + capsaicin||0.07|-0.80|0.0956
73917674|NCT02700815|147363702|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.157||0.0564|TWO_SIDED|95.0|-0.01|0.61|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between capsaicin and combination therapy diclofenac + capsaicin||0.61|-0.01|0.0564
73860684|NCT00740714|147267533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09|STANDARD_ERROR_OF_MEAN|0.86|>|0.025|TWO_SIDED|95.0|-0.85|3.03||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 2400 mg/day arm compared to placebo group.||3.03|-0.85|>0.025
73860685|NCT00740714|147267534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.84||0.7943|TWO_SIDED|97.5|-2.12|1.68||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Schwab \& England will be analyzed using ANCOVA in the same way as for the primary outcome variable.||1.68|-2.12|0.7943
73860686|NCT00740714|147267534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.85||0.306||95.0|-2.79|1.04||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month on Modified Schwab \& England will be analyzed using ANCOVA in the same way as for the primary outcome variable.||1.04|-2.79|0.306
73860687|NCT00740714|147267535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06|<|0.1615|TWO_SIDED|97.5|-0.25|0.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.06|-0.25|<0.1615
73860688|NCT00740714|147267535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.7627|TWO_SIDED|95.0|-0.17|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-Adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plats and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.13|-0.17|0.7627
73860689|NCT00740714|147267536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6383|STANDARD_ERROR_OF_MEAN|1.18||0.6383|TWO_SIDED|97.5|-2.1|3.21||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||3.21|-2.10|0.6383
73860690|NCT00740714|147267536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|1.19||0.667|TWO_SIDED|95.0|-3.2|2.17||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||2.17|-3.20|0.667
73860691|NCT00740714|147267537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|1.14||0.671|TWO_SIDED|97.5|-2.09|3.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable.||3.06|-2.09|0.671
73860692|NCT00740714|147267537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|1.16||0.671|TWO_SIDED|95.0|-3.34|1.87||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable||1.87|-3.34|0.671
73860693|NCT00740714|147267538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3445|TWO_SIDED|97.5|-0.04|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Hoehn \& Yahr Score will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.13|-0.04|0.3445
73966650|NCT02140645|147469841|SUPERIORITY_OR_OTHER||C-statistics|0.827|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73966651|NCT02140645|147469842|SUPERIORITY_OR_OTHER||C-statistics|0.801|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73860694|NCT00740714|147267538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.05||0.239||95.0|-0.04|0.14||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided. with a Bonferroni-adjustd significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assess with scatter and residual plots and ITT.||Change from Baseline visit to 16-month visit on Hoehn \& Yahr will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.14|-0.04|.239
73860695|NCT00740714|147267539|SUPERIORITY_OR_OTHER||Slope|0.536|STANDARD_ERROR_OF_MEAN|0.282||0.0577|TWO_SIDED|95.0|-0.018|1.091|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final visit to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for all treatment groups.||1.091|-0.018|0.0577
73860696|NCT00740714|147267539|SUPERIORITY_OR_OTHER||Slope|0.245|STANDARD_ERROR_OF_MEAN|0.451||0.5889|TWO_SIDED|95.0|-0.647|1.136|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 2400 mg/day.||1.136|-0.647|0.5889
73860697|NCT00740714|147267539|SUPERIORITY_OR_OTHER||Slope|0.631|STANDARD_ERROR_OF_MEAN|0.608||0.3006|TWO_SIDED|95.0|-0.569|1.831|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 1200 mg/day.||1.831|-0.569|0.3006
73860698|NCT00740714|147267539|SUPERIORITY_OR_OTHER||Slope|2.126|STANDARD_ERROR_OF_MEAN|1.269||0.096|TWO_SIDED|95.0|-0.382|4.633|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the placebo group.||4.633|-0.382|0.096
73860699|NCT00740714|147267540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|STANDARD_ERROR_OF_MEAN|0.0199|<|0.05|TWO_SIDED|95.0|0.57|2.8|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||2.80|0.57|<0.05
73860700|NCT00740714|147267541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.62|3.57|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subject experiencing a particular adverse experience||3.57|0.62|<0.05
73860701|NCT00740714|147267542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.65|4.2|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||4.20|0.65|<0.05
73860702|NCT00740714|147267543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|0.46|1.79|||ANCOVA||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.79|0.46|<0.05
73860703|NCT00740714|147267544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|STANDARD_ERROR_OF_MEAN|0.0199|<|0.05|TWO_SIDED|95.0|0.66|3.41|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||3.41|0.66|<0.05
73860704|NCT00740714|147267545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.81|9.72|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9.72|0.81|<0.05
73860705|NCT00740714|147267546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.31|1.52|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.52|0.31|<0.05
73860706|NCT00740714|147267547|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.36|1.7|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.70|0.36|<0.05
73966652|NCT02140645|147469843|SUPERIORITY_OR_OTHER||C-statistics|0.836|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
73966653|NCT01101451|147469844|SUPERIORITY||Hazard Ratio (HR)|0.6976||||0.0927|TWO_SIDED|95.0|0.408|1.192||the pre\_specified nominal significance level was 0.0451 (one sided).|Log Rank||The RFS hazard ratio estimate is for reporting group 2 vs reporting group 1.|||1.192|0.408|0.0927
73917675|NCT02700815|147363702|SUPERIORITY||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.157||0.0004|TWO_SIDED|95.0|-0.87|-0.25|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between diclofenac and combination therapy diclofenac + capsaicin||-0.25|-0.87|0.0004
73917676|NCT02700815|147363703|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.238||0.0347|TWO_SIDED|95.0|-0.97|-0.04|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between placebo and combination therapy diclofenac + capsaicin||-0.04|-0.97|0.0347
73917677|NCT02700815|147363703|SUPERIORITY||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.169||0.0622|TWO_SIDED|95.0|-0.02|0.65|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between capsaicin and combination therapy diclofenac + capsaicin||0.65|-0.02|0.0622
73917678|NCT02700815|147363703|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.169|<|0.0001|TWO_SIDED|95.0|-1.01|-0.35|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between diclofenac and combination therapy diclofenac + capsaicin||-0.35|-1.01|<0.0001
73917679|NCT02700815|147363704|SUPERIORITY||Odds Ratio (OR)|1.882||||0.0202|TWO_SIDED|95.0|1.1|3.21|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.21|1.10|0.0202
73917680|NCT02700815|147363704|SUPERIORITY||Odds Ratio (OR)|0.732||||0.1206|TWO_SIDED|95.0|0.49|1.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||1.09|0.49|0.1206
73917681|NCT02700815|147363704|SUPERIORITY||Odds Ratio (OR)|1.629||||0.0122|TWO_SIDED|95.0|1.11|2.39|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||2.39|1.11|0.0122
73917682|NCT02700815|147363705|SUPERIORITY||Odds Ratio (OR)|1.729||||0.0643|TWO_SIDED|95.0|0.97|3.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.09|0.97|0.0643
73917683|NCT02700815|147363705|SUPERIORITY||Odds Ratio (OR)|0.833||||0.3479|TWO_SIDED|95.0|0.57|1.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||1.22|0.57|0.3479
73917684|NCT02700815|147363705|SUPERIORITY||Odds Ratio (OR)|2.125||||0.0004|TWO_SIDED|95.0|1.4|3.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.22|1.40|0.0004
73917685|NCT02700815|147363706|SUPERIORITY||Mean Difference (Net)|-1.05|STANDARD_ERROR_OF_MEAN|0.313||0.0008|TWO_SIDED|95.0|-1.67|-0.44|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.44|-1.67|0.0008
73917686|NCT02700815|147363706|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.223||0.3726|TWO_SIDED|95.0|-0.24|0.64|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||0.64|-0.24|0.3726
73966654|NCT01101451|147469845|SUPERIORITY||Hazard Ratio (HR)|0.586|||||TWO_SIDED|95.0|0.286|1.199|||||The OS hazard ratio estimate is for reporting group 2 vs reporting group 1.|||1.199|0.286|
73966655|NCT06647238|147469858|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73966656|NCT04455035|147469981|OTHER|ttest||||||0.0088|||||||t-test, 2 sided|||||||0.0088
73966657|NCT04455035|147469982|OTHER|ttest||||||1e-05|||||||t-test, 2 sided|||||||0.00001
74086459|NCT01876368|147726433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.19|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.73|-1.65|||ANCOVA|||||-1.65|-4.73|<0.001
74086460|NCT01867606|147726446|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
73966658|NCT04052516|147470047|OTHER|Cochran-Mantel-Haenszal test|Odds Ratio (OR)|1.7||||0.2991|TWO_SIDED|95.0|0.62|4.63|||Cochran-Mantel-Haenszel|||||4.63|0.62|0.2991
73860707|NCT00740714|147267548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.69|8.58|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||8.58|0.69|<0.05
73860708|NCT00740714|147267549|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.31|1.62|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.62|0.31|<0.05
73860709|NCT00740714|147267550|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|2.77|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|2.77|<0.05
73860710|NCT00740714|147267551|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.25|1.12|||Fisher Exact||Odds ration \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.12|0.25|<0.05
73860711|NCT00740714|147267552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|0.64|8.01|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||8.01|0.64|<0.05
73860712|NCT00740714|147267553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.55|3.24|||Fisher Exact||Odds ratio of \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||3.24|0.55|<0.05
73860713|NCT00740714|147267554|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.48|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|0.48|<0.05
73860714|NCT00740714|147267555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|2.51|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|2.51|<0.05
73860715|NCT03688555|147267556|SUPERIORITY||LS means difference|0.76|STANDARD_ERROR_OF_MEAN|0.301|=|0.062|TWO_SIDED|95.0|-0.06|1.59||All Nasal Polyp Score (NPS) values observed between baseline and Week 12 were included in the analysis. Changes from baseline to post-baseline visits in NPS were analyzed using a Mixed Model for Repeated Measurement (MMRM).|Mixed model for repeated measurements|||||1.59|-0.06|= 0.062
73860716|NCT03688555|147267557|SUPERIORITY||LS means difference|-3.98|STANDARD_ERROR_OF_MEAN|2.316|=|0.161|TWO_SIDED|95.0|-10.41|2.45|||ANCOVA|||||2.45|-10.41|= 0.161
73860717|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 3 months.||||0.0078
73860718|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 18 months.||||0.0078
73917687|NCT02700815|147363706|SUPERIORITY||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.56|-0.68|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.68|-1.56|<0.0001
73917688|NCT02700815|147363707|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.844||0.881|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.53|-1.78|0.8810
73966659|NCT04052516|147470047|OTHER|Cochran-Mantel-Haenszel Test|Odds Ratio (OR)|2.01||||0.1386|TWO_SIDED|95.0|0.8|5.08|||Cochran-Mantel-Haenszel|||||5.08|0.80|0.1386
73966660|NCT05386355|147470076|SUPERIORITY||Risk Ratio (RR)|1.79|||||TWO_SIDED|95.0|0.59|5.35|||||The General Health App is the reference group.|A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.||5.35|0.59|
74086461|NCT01867606|147726448|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
73860719|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0313||95.0||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 24 months.||||0.0313
73860720|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from 3 months to 18 months.||||0.0078
73860721|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the skull from 18 months to 24 months.||||0.0156
73860722|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 3 months.||||0.0156
73860723|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 18 months.||||0.0078
73860724|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.1563||95.0||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 24 months.||||0.1563
73860725|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.4375||95.0||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from 3 months to 18 months.||||0.4375
73860726|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the mandible from 18 months to 24 months.||||0.0781
73860727|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0371||95.0||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 3 months.||||0.0371
73860728|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0137||95.0||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 18 months.||||0.0137
73860729|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0547||95.0||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 24 months.||||0.0547
73860730|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0488||95.0||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from 3 months to 18 months.||||0.0488
73860731|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.3594||95.0||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the spine from 18 months to 24 months.||||0.3594
73860732|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0488||95.0||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 3 months.||||0.0488
73860733|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.1055||95.0||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 18 months.||||0.1055
73860734|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.9102||95.0||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 24 months.||||0.9102
73966661|NCT05386355|147470077|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.42|1.65|||||The General Health App is the reference group.|A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.||1.65|0.42|
73860735|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 3 months to 18 months.||||0.1934
73860736|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 18 months to 24 months.||||0.1641
73860737|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0137||95.0||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 3 months.||||0.0137
73860738|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 18 months.||||0.0020
73860739|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 24 months.||||0.0039
73860740|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 3 months to 18 months.||||0.0273
73860741|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0547||95.0||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 18 months to 24 months.||||0.0547
73966662|NCT05386355|147470078|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.638|TWO_SIDED|95.0|-1.19|0.73|||Mixed Models Analysis|The analytical method was based on a linear mixed model adjusting for baseline SAGE vaccine hesitancy composite scores and random clinic effect.||||0.73|-1.19|0.638
73860742|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0195||95.0||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 3 months.||||0.0195
73860743|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0059||95.0||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 18 months.||||0.0059
73860744|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.5703||95.0||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 24 months.||||0.5703
73860745|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 3 months to 18 months.||||0.1934
73860746|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 18 months to 24 months.||||0.0039
73860747|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for whole body, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 3 months.||||0.0039
73860748|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.5703||95.0||||p-value is for whole body, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 24 months.||||0.5703
73860749|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for whole body, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from 3 months to 18 months.||||0.0273
73917689|NCT02700815|147363707|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.601||0.6094|TWO_SIDED|95.0|-0.87|1.49|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.49|-0.87|0.6094
73917690|NCT02700815|147363707|SUPERIORITY||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|0.602||0.2047|TWO_SIDED|95.0|-0.42|1.95|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.95|-0.42|0.2047
73917691|NCT02700815|147363708|SUPERIORITY||Mean Difference (Net)|1.65|STANDARD_ERROR_OF_MEAN|1.339||0.2193|TWO_SIDED|95.0|-0.98|4.27|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||4.27|-0.98|0.2193
73917692|NCT02700815|147363708|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.949||0.7672|TWO_SIDED|95.0|-1.58|2.15|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||2.15|-1.58|0.7672
73917693|NCT02700815|147363708|SUPERIORITY||Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|0.95||0.0339|TWO_SIDED|95.0|0.15|3.88|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||3.88|0.15|0.0339
73917694|NCT03758274|147363709|SUPERIORITY|||||||0.746|||||||Based on simple path model in Mplus.|||||||0.746
73917695|NCT03758274|147363710|SUPERIORITY|||||||0.247|||||||Based on simple path model in Mplus.|||||||0.247
73917696|NCT03758274|147363711|SUPERIORITY|||||||0.689|||||||Chi-squared|||||||0.689
73917697|NCT00842712|147363757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.718||||0.0845|TWO_SIDED|95.0|0.492|1.048|||Log Rank|||PFS Time: Independent read||1.048|0.492|0.0845
73917698|NCT00842712|147363758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.909||||0.5912|TWO_SIDED|95.0|0.642|1.286|||Log Rank|||||1.286|0.642|0.5912
73917699|NCT00842712|147363759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.813||||0.2648|TWO_SIDED|95.0|0.564|1.171|||Log Rank|||||1.171|0.564|0.2648
73917700|NCT00875212|147363762|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.5|STANDARD_DEVIATION|0.25||0.001||95.0|||||ANOVA|repeated measure anova|The median value of each parameter (pH baseline, minimal pH) was obtained and these values were compared between each group|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The null hyphothesis was no difference between pH values of the groups. The statistical analysis was by repeated measurements ANOVA.||||0.001
73966663|NCT06143670|147470079|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
73860750|NCT00259298|147267580|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value if for whole body, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the whole body from 18 months to 24 months.||||0.0039
73860751|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for whole skeleton, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 3 months.||||0.0098
73860752|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for whole skeleton, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 18 months.||||0.0039
73860753|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for whole skeleton, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 24 months.||||0.6523
73860754|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||p-value is for whole skeleton, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 3 months to 18 months.||||0.1641
73860755|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for whole skeleton, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 18 months to 24 months.||||0.0078
73860756|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 3 months.||||0.0078
73860757|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 18 months.||||0.0078
73860758|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the skull from baseline to 24 months.||||0.0781
73860759|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from 3 months to 18 months.||||0.0078
73860760|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the skull from 18 months to 24 months.||||0.0156
73860761|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0391||95.0||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 3 months.||||0.0391
73860762|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0313||95.0||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 18 months.||||0.0313
73917701|NCT00875212|147363762|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.5|STANDARD_DEVIATION|0.1||0.001||95.0|||||ANOVA|repeated-measurements ANOVA||The comparison was based on mean and median values of plaque pH in different moments of cariogenic challenge. The null hypothesis was that no diference between the groups wil be found. The test hypothesis was that the experimental dentifrice of CaGP-F would provide a better control of plaque pH after 14 days of use.||||0.001
74027668|NCT03114969|147608621|SUPERIORITY||Odds Ratio (OR)|1.51||||0.472|TWO_SIDED|95.0|0.492|4.633||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.633|0.492|0.472
74027669|NCT03114969|147608621|SUPERIORITY||Odds Ratio (OR)|1.402||||0.553|TWO_SIDED|95.0|0.459|4.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.283|0.459|0.553
73860763|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.2969||95.0||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 24 months.||||0.2969
73860764|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.5625||95.0||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from 3 months to 18 months.||||0.5625
73860765|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0469||95.0||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the mandible from 18 months to 24 months.||||0.0469
73860766|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from 3 months to 18 months.||||0.1934
73860767|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.2324||95.0||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 3 months.||||0.2324
73860768|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0645||95.0||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 18 months.||||0.0645
73917702|NCT00875212|147363763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_DEVIATION|0.25||0.01||95.0|||||ANOVA|repeated measurements ANOVA|The difference of pH values between groups was above 1.0 unit.|The groups were compared by repeated measurements anova. There was no power calculation, but a pilot study to check the minimal number necessary of subjects in order to find a signifcant difference between interventions.||||0.01
73917703|NCT02310568|147363765|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.01||0.784|TWO_SIDED|90.0|-2.8|3.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.9|-2.8|0.784
73917704|NCT02310568|147363765|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.94||0.184|TWO_SIDED|90.0|-0.6|5.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||5.8|-0.6|0.184
73917705|NCT02310568|147363765|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.22||0.36|TWO_SIDED|90.0|-5.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||1.6|-5.7|0.360
73917706|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.36||0.708|TWO_SIDED|90.0|-3.2|5.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||5.0|-3.2|0.708
73917707|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.36||0.646|TWO_SIDED|90.0|-5.2|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||3.0|-5.2|0.646
73860769|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the spine from baseline to 24 months.||||0.0273
73966664|NCT06143670|147470080|SUPERIORITY||Adjusted Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.0001|TWO_SIDED|95.0|-19.6|-14.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-14.1|-19.6|<0.0001
73966665|NCT06143670|147470081|SUPERIORITY||Adjusted Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-18.9|-13.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-13.1|-18.9|<0.0001
74086462|NCT00292227|147726478|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.75||||||90.0|-2.63|1.12|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.12|-2.63|
73860770|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.7344||95.0||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the spine from 18 months to 24 months.||||0.7344
73860771|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 3 months.||||0.1934
73860772|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.7695||95.0||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 18 months.||||0.7695
73860773|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 24 months.||||0.6523
73917708|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.09||0.352|TWO_SIDED|90.0|-1.6|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||5.6|-1.6|0.352
73860774|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.2324||95.0||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from 3 months to 18 months.||||0.2324
73860775|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the pelvis from 18 months to 24 months.||||0.6523
73860776|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 3 months.||||0.0098
73860777|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 18 months.||||0.0020
73860778|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 24 months.||||0.0039
74086463|NCT00292227|147726479|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.01||||||90.0|-2.21|2.19|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.19|-2.21|
74086464|NCT00292227|147726480|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.84||||||90.0|-1.12|2.8|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.80|-1.12|
74088404|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|0.2455|STANDARD_ERROR_OF_MEAN|0.1757||0.1667|||||||Regression, Linear|||This is a regression analysis for testing the effect of treatment arm (Recombivax vs. Twinrix) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.1667
73860779|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from 3 months to 18 months.||||0.0273
73860780|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.3594||95.0||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the upper extremities from 18 months to 24 months.||||0.3594
73860781|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0371||95.0||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 3 months.||||0.0371
73860782|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 18 months.||||0.0098
73860783|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.4609||95.0||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 24 months.||||0.4609
73860784|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from 3 months to 18 months.||||0.1934
73860785|NCT00259298|147267581|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the lower extremities from 18 months to 24 months.||||0.0273
73860786|NCT00259298|147267582|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for focal change, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 3 months.||||1.0
73860787|NCT00259298|147267582|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for focal change, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 18 months.||||1.0
73860788|NCT00259298|147267584|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for change at 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in whole skeletal plasma clearance of 99m Tc-MDP from baseline to 18 months.||||0.0020
73860789|NCT01741532|147267605|SUPERIORITY|||||||0.0761|||||||Mixed Models Analysis|||||||0.0761
73860790|NCT01741532|147267606|SUPERIORITY|||||||0.7279|||||||Mixed Models Analysis|||||||0.7279
73860791|NCT01741532|147267607|SUPERIORITY|||||||0.7228|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part I||||0.7228
73860792|NCT01741532|147267607|SUPERIORITY|||||||0.3677|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part II||||0.3677
73860793|NCT01741532|147267607|SUPERIORITY|||||||0.2182|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part III||||0.2182
73860794|NCT01741532|147267607|SUPERIORITY|||||||0.1749|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part VI||||0.1749
73860795|NCT01741532|147267608|SUPERIORITY|||||||0.1524|||||||Mixed Models Analysis|||||||0.1524
73860796|NCT01741532|147267609|SUPERIORITY|||||||0.2026|||||||Mixed Models Analysis|||||||0.2026
73860797|NCT01741532|147267610|SUPERIORITY|||||||0.9759|||||||Mixed Models Analysis|||Patient self-report, total score||||0.9759
73860798|NCT01741532|147267610|SUPERIORITY|||||||0.5781|||||||Mixed Models Analysis|||Parent proxy-report, total score||||0.5781
73860799|NCT01741532|147267611|SUPERIORITY|||||||0.6323|||||||Mixed Models Analysis|||||||0.6323
73860800|NCT01741532|147267612|SUPERIORITY|||||||0|||||||Mixed Models Analysis|||||||0.0000
73860801|NCT01071356|147267646|SUPERIORITY_OR_OTHER||Time averaged post-bline diff in diff|-0.006||||0.47|TWO_SIDED|95.0|-0.023|0.011|||Random Effects modeling||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.||.011|-.023|.47
74088405|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficent|-0.0025|STANDARD_ERROR_OF_MEAN|0.1792||0.989||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of site effect(Other sites vs. Baltimore) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.9890
74088406|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coeffcient|0.2053|STANDARD_ERROR_OF_MEAN|0.1885||0.2796||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of age(15 - 17 year old particpants vs. 12 - 14 year old participants) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2796
73860802|NCT01071356|147267647|SUPERIORITY_OR_OTHER||Time averaged post-bline diff in diff|0.007||||0.034|TWO_SIDED|95.0|0.001|0.013|||Random effects model||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.||.013|.001|.034
73860803|NCT02558400|147267652|SUPERIORITY|To claim superiority PG324 had to be statistically superior to netarsudil and to latanoprost at all 9 of 9 primary efficacy timepoints|||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil||||||<0.0001
73860804|NCT02558400|147267652|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost||||||<0.0001
73860805|NCT03654885|147267659|NON_INFERIORITY|By assuming the margin of non-inferiority at 24%, the null hypothesis for this non-inferiority testing was to be set up as XEN implanted group (P1)-Trabeculectomy group (P2) ≤-0.24 versus the alternative hypothesis as P1-P2 \>-0.24. Equivalently, non-inferiority of P1 to P2 was to be declared if the lower limit of the 2-sided confidence interval (CI) of the difference of the above endpoint between the two treatment groups computed using normal approximation was found to be greater than -24%.|Percentage Difference|-6.1||||0.487|TWO_SIDED|95.0|-22.9|10.8|||Chi-squared|||||10.8|-22.9|0.487
73860806|NCT03654885|147267661|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-5.81|STANDARD_ERROR_OF_MEAN|1.155|<|0.001|TWO_SIDED|95.0|-8.074|-3.538||Mixed Model for Repeated Measures (MMRM) model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Day 1||-3.538|-8.074|<0.001
73860807|NCT03654885|147267661|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-0.22|STANDARD_ERROR_OF_MEAN|1.163||0.851|TWO_SIDED|95.0|-2.503|2.066||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Week 1||2.066|-2.503|0.851
73966666|NCT06143670|147470081|SUPERIORITY||Adjusted Mean Difference|-17.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-19.9|-15.3|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-15.3|-19.9|<0.0001
73966667|NCT06143670|147470082|SUPERIORITY||Adjusted Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|-0.35|-0.2|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.20|-0.35|<0.0001
73966668|NCT06143670|147470082|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|-0.26|-0.13|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.13|-0.26|<0.0001
73966669|NCT06143670|147470082|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.36|-0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.22|-0.36|<0.0001
73966670|NCT06143670|147470083|SUPERIORITY||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.28|-0.16|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.16|-0.28|<0.0001
73966671|NCT06143670|147470083|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|-0.21|-0.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.10|-0.21|<0.0001
73966672|NCT06143670|147470083|SUPERIORITY||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.3|-0.18|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.18|-0.30|<0.0001
73966673|NCT06143670|147470084|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.15|-0.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.10|-0.15|<0.0001
73966674|NCT06143670|147470084|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.17|-0.13|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.13|-0.17|<0.0001
73966675|NCT06143670|147470084|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.16|-0.11|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.11|-0.16|<0.0001
73966676|NCT06143670|147470085|SUPERIORITY||Adjusted Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.74|-0.53|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.53|-0.74|<0.0001
73966677|NCT06143670|147470085|SUPERIORITY||Adjusted Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.74|-0.56|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.56|-0.74|<0.0001
73966678|NCT06143670|147470085|SUPERIORITY||Adjusted Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.77|-0.58|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.58|-0.77|<0.0001
73966679|NCT02815813|147470090|SUPERIORITY||||||<|0.01|||||||GLMM|||||||<0.01
73917709|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.99||0.495|TWO_SIDED|90.0|-3.1|7.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.3|-3.1|0.495
73917710|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.99||0.422|TWO_SIDED|90.0|-2.7|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.6|-2.7|0.422
73917711|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.65||0.889|TWO_SIDED|90.0|-5.0|4.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||4.2|-5.0|0.889
73917712|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|2.71||0.324||90.0|-2.0|7.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.4|-2.0|0.324
73917713|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|2.69||0.939|TWO_SIDED|90.0|-4.5|4.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||4.9|-4.5|0.939
73917714|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.42||0.308|TWO_SIDED|90.0|-1.7|6.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||6.7|-1.7|0.308
73917715|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|3.92||0.846|TWO_SIDED|90.0|-6.0|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.6|-6.0|0.846
73917716|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|3.89||0.449|TWO_SIDED|90.0|-9.8|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||3.7|-9.8|0.449
73917717|NCT02310568|147363767|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|3.51||0.295|TWO_SIDED|90.0|-2.3|9.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||9.9|-2.3|0.295
73917718|NCT02310568|147363769|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.72||0.514|TWO_SIDED|90.0|-4.0|1.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-4.0|0.514
73917719|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.65||0.302|TWO_SIDED|90.0|-4.5|1.0|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.0|-4.5|0.302
73917720|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.94||0.736|TWO_SIDED|90.0|-2.6|3.8|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.8|-2.6|0.736
73917721|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|3.85||0.775|TWO_SIDED|90.0|-5.6|7.8|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||7.8|-5.6|0.775
74088407|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regresssion coeffcient|-0.4726|STANDARD_ERROR_OF_MEAN|0.1734||0.008||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of gender(Females vs. Males) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0080
74088408|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|0.2189|STANDARD_ERROR_OF_MEAN|0.1905||0.2543||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Hispanic ethnicity (Not Hispanic vs. Hispanic) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2543
73917722|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|4.0||0.553|TWO_SIDED|90.0|-9.4|4.5|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||4.5|-9.4|0.553
73860808|NCT03654885|147267661|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.03|STANDARD_ERROR_OF_MEAN|1.162||0.081|TWO_SIDED|95.0|-0.253|4.309||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Week 2||4.309|-0.253|0.081
73860809|NCT03654885|147267661|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.21|STANDARD_ERROR_OF_MEAN|1.157||0.056|TWO_SIDED|95.0|-0.059|4.484||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 1||4.484|-0.059|0.056
73860810|NCT03654885|147267661|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|4.74|STANDARD_ERROR_OF_MEAN|1.181|<|0.001|TWO_SIDED|95.0|2.416|7.054||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 3||7.054|2.416|<0.001
73860811|NCT03654885|147267661|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|3.01|STANDARD_ERROR_OF_MEAN|1.197||0.012|TWO_SIDED|95.0|0.657|5.358||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 6||5.358|0.657|0.012
73860812|NCT03654885|147267661|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|3.53|STANDARD_ERROR_OF_MEAN|1.197||0.003|TWO_SIDED|95.0|1.182|5.883||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 9||5.883|1.182|0.003
73860813|NCT03654885|147267661|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.77|STANDARD_ERROR_OF_MEAN|1.229||0.024|TWO_SIDED|95.0|0.358|5.183||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 12||5.183|0.358|0.024
73860814|NCT03654885|147267663|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.505|TWO_SIDED|95.0|-0.36|0.18||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Day 1||0.18|-0.36|0.505
73860815|NCT03654885|147267663|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.949|TWO_SIDED|95.0|-0.28|0.26||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 1||0.26|-0.28|0.949
73860816|NCT03654885|147267663|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.581|TWO_SIDED|95.0|-0.19|0.34||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 2||0.34|-0.19|0.581
73860817|NCT03654885|147267663|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.302|TWO_SIDED|95.0|-0.13|0.41||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 1||0.41|-0.13|0.302
73860818|NCT03654885|147267663|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.4|STANDARD_ERROR_OF_MEAN|0.14||0.005|TWO_SIDED|95.0|0.12|0.66||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 3||0.66|0.12|0.005
73860819|NCT03654885|147267663|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.026|TWO_SIDED|95.0|0.04|0.59||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 6||0.59|0.04|0.026
73966680|NCT02815813|147470091|SUPERIORITY||||||<|0.01|||||||GLMM|||||||<0.01
73966681|NCT04995484|147470106|OTHER||Geometric Mean Ratio|1.52|||||TWO_SIDED|90.0|0.95|2.43|||||Moderate Hepatic Impairment/Healthy|||2.43|0.95|
73966682|NCT04995484|147470107|OTHER||Geometric Mean Ratio|1.09|||||TWO_SIDED|90.0|0.84|1.42|||||Moderate Hepatic Impairment/Healthy|||1.42|0.84|
73966683|NCT04995484|147470108|OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.76|1.26|||||Moderate Hepatic Impairment/Healthy|||1.26|0.76|
73966684|NCT00837369|147470113|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0||||Compare the differences in sensitivity between myocardial perfusion and wall motion for detecting stenosis.|Chi-squared|||||||<0.001
73966685|NCT00837369|147470113|SUPERIORITY||||||<|0.001||||||Compare the sensitivity of myocardial perfusion in detecting stenosis within the first 4 minutes after regadenoson bolus injection to that of wall motion|Chi-squared|||||||<0.001
73966686|NCT00739648|147470171|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7282|TWO_SIDED|90.0|0.86|1.39|||Regression, Linear|negative binomial regression model||||1.39|0.86|0.7282
73966687|NCT00739648|147470173|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-15.2||||0.9768|TWO_SIDED|90.0|-27.8|-2.66|||Mixed Models Analysis|||||-2.66|-27.8|0.9768
73966688|NCT00739648|147470174|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.3||||0.9464|TWO_SIDED|90.0|-24.9|0.26|||Mixed Models Analysis|||||0.26|-24.9|0.9464
73917723|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|3.3||0.299|TWO_SIDED|90.0|-2.2|9.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||9.3|-2.2|0.299
73917724|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.65||0.994|TWO_SIDED|90.0|-1.1|1.1|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-1.1|0.994
73917725|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.87|TWO_SIDED|90.0|-0.9|1.1|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-0.9|0.870
73917726|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.74||0.885|TWO_SIDED|90.0|-1.3|1.1|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-1.3|0.885
73917727|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.78||0.834|TWO_SIDED|90.0|-3.5|2.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.7|-3.5|0.834
73917728|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.8||0.281|TWO_SIDED|90.0|-5.1|1.1|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-5.1|0.281
73917729|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.43||0.272|TWO_SIDED|90.0|-0.9|4.1|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||4.1|-0.9|0.272
73917730|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.249|TWO_SIDED|90.0|-2.1|0.4|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.4|-2.1|0.249
73917731|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.016|TWO_SIDED|90.0|-2.9|-0.6|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||-0.6|-2.9|0.016
73917732|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.82||0.285|TWO_SIDED|0.285|-0.5|2.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.3|-0.5|0.285
73917733|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.38||0.635|TWO_SIDED|90.0|-3.1|1.8|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.8|-3.1|0.635
73966689|NCT04173663|147470181|SUPERIORITY||Slope|-3.27||||0.092|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the parental empowerment scale.||||||.092
73966690|NCT04173663|147470182|SUPERIORITY||Slope|-1.62||||1.54e-05|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.0000154
73966691|NCT04173663|147470183|SUPERIORITY||Slope|-0.19||||0.014|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.014
73966692|NCT04173663|147470184|SUPERIORITY||Slope|-0.13||||0.883|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||0.883
73966693|NCT04173663|147470185|SUPERIORITY||Slope|-0.11||||0.308|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of services family applied for (6 month post intervention)||||.308
73917734|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.43||0.217|TWO_SIDED|90.0|-4.4|0.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.7|-4.4|0.217
73917735|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.36||0.399|TWO_SIDED|90.0|-1.2|3.6|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.6|-1.2|0.399
73917736|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62||0.429|TWO_SIDED|90.0|-1.5|0.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.5|-1.5|0.429
73917737|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.26|TWO_SIDED|90.0|-1.7|0.3|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.3|-1.7|0.260
73860820|NCT03654885|147267663|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.4|STANDARD_ERROR_OF_MEAN|0.14||0.01|TWO_SIDED|95.0|0.09|0.64||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 9||0.64|0.09|0.010
73966694|NCT04173663|147470185|SUPERIORITY||Slope|-0.11||||0.355|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of services family applied for (12 month post intervention)||||.355
73966695|NCT04173663|147470186|SUPERIORITY||Slope|-0.06||||0.699|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of government services family is receiving (6 month post intervention)||||.699
74086465|NCT00292227|147726481|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.26||||||90.0|-1.8|2.32|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.32|-1.80|
73966696|NCT04173663|147470186|SUPERIORITY||Slope|-0.1||||0.573|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of government services the family is receiving (12 month post intervention)||||.573
73966697|NCT04173663|147470186|SUPERIORITY||Slope|-0.23||||0.43|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of direct services the family is receiving (6 month post intervention)||||.430
73966698|NCT04173663|147470186|SUPERIORITY||Slope|0.27||||0.391|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of direct services the family is receiving (12 month post intervention)||||.391
73966699|NCT04173663|147470187|SUPERIORITY||Slope|-0.44||||0.51|TWO_SIDED||||||Regression, Logistic|Logistic regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Whether participants were engaged or not engaged in vocational/educational activities (6 month post intervention)||||.510
73966700|NCT04173663|147470187|SUPERIORITY||Slope|0.64||||0.296|TWO_SIDED||||||Regression, Logistic|Logistic regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Whether participants were engaged or not engaged in vocational/educational activities (12 month post intervention)||||.296
73966701|NCT04173663|147470188|SUPERIORITY||Slope|-0.66||||0.361|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.361
73966702|NCT04173663|147470189|SUPERIORITY||Slope|-0.08||||0.81|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of unmet service needs (6 month post intervention)||||.810
73966703|NCT04173663|147470189|SUPERIORITY||Slope|-0.13||||0.678|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of unmet service needs (12 month post intervention)||||.678
73966704|NCT04173663|147470190|SUPERIORITY||Slope|0.03||||0.924|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site and cohort,||||||.924
73966705|NCT01757665|147470192|SUPERIORITY||percent of patients|0.1|||||ONE_SIDED|95.0||0.7|||||Upper 95% CI was calculated by the method of Clopper and Pearson, using the Beta distribution with parameters x + 1 and n - x where x is the number of SVD events by POD 390 and n is the number of subjects followed at the 1 year assessment.|The null hypothesis is that the rate of structural valve deterioration at one year is greater than 1%. The alternative hypothesis is that this rate is less than 1%.||0.7||
73966706|NCT04640961|147470304|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
73966707|NCT04640961|147470305|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
74027670|NCT03114969|147608622|SUPERIORITY||Odds Ratio (OR)|2.523||||0.052|TWO_SIDED|95.0|0.993|6.407||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.407|0.993|0.052
74027671|NCT03114969|147608622|SUPERIORITY||Odds Ratio (OR)|2.757||||0.029|TWO_SIDED|95.0|1.107|6.862||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.862|1.107|0.029
74027672|NCT03114969|147608623|SUPERIORITY||Odds Ratio (OR)|2.434||||0.024|TWO_SIDED|95.0|1.123|5.276||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.276|1.123|0.024
74027673|NCT03114969|147608623|SUPERIORITY||Odds Ratio (OR)|2.389||||0.035|TWO_SIDED|95.0|1.061|5.376||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.376|1.061|0.035
74027674|NCT03114969|147608623|SUPERIORITY||Odds Ratio (OR)|2.889||||0.003|TWO_SIDED|95.0|1.434|5.819||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.819|1.434|0.003
74027675|NCT03114969|147608623|SUPERIORITY||Odds Ratio (OR)|2.974||||0.003|TWO_SIDED|95.0|1.461|6.055||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.055|1.461|0.003
74027676|NCT00949650|147608624|SUPERIORITY_OR_OTHER|||||||0.0002||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0002
74027677|NCT00949650|147608624|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576||||0.0002||95.0|0.426|0.778|||Regression, Cox|Cox Proportional Hazard (PH) regression stratified by epidermal growth factor receptor (EGFR) mutation group and race.|Afatinib 40 mg versus Pemetrexed/Cisplatin Chemotherapy.|||0.778|0.426|0.0002
74027678|NCT00949650|147608625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.802|||<|0.0001||95.0|2.855|8.075|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||8.075|2.855|<0.0001
74088409|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|0.2994|STANDARD_ERROR_OF_MEAN|0.3292||0.3661||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Other/Mixed Race is presented.||||0.3661
73966708|NCT04640961|147470306|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
74027679|NCT00949650|147608626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.288||||0.0118||95.0|1.202|4.356|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||4.356|1.202|0.0118
74027680|NCT00949650|147608627|SUPERIORITY_OR_OTHER|||||||0.7916||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.7916
74027681|NCT00949650|147608627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.385||95.0|0.66|1.174|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||1.174|0.660|0.3850
73971371|NCT05192109|147483239|OTHER||||||<|0.01||||||This is the p-value for the interaction between condition and group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
73971372|NCT04865289|147483260|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.51|1.41||||||||1.41|0.51|
74027682|NCT00949650|147608628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.82|||<|0.0001||95.0|-13.64|-5.99|||ANCOVA|Adjusted for baseline SoD, EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||-5.99|-13.64|<0.0001
74086466|NCT00292227|147726482|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.11||||||90.0|-2.25|2.02|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.02|-2.25|
73860821|NCT03654885|147267663|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.052|TWO_SIDED|95.0|0.0|0.54||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 12||0.54|0.00|0.052
73860822|NCT03654885|147267664|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|1.229||0.024|TWO_SIDED|95.0|0.358|5.183||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||5.183|0.358|0.024
73860823|NCT03654885|147267665|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.052|TWO_SIDED|95.0|0.0|0.54||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||0.54|0.00|0.052
73917738|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.7||0.799|TWO_SIDED|90.0|-1.0|1.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.3|-1.0|0.799
73917739|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.22||0.738|TWO_SIDED|90.0|-1.7|2.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.5|-1.7|0.738
73917740|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|-0.5||0.691|TWO_SIDED|90.0|-2.7|1.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-2.7|0.691
73966709|NCT03052608|147470309|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.191|0.413||The study was to be considered positive if the 1-sided log-rank test for PFS, stratified for baseline stratification factors (ethnicity and brain metastases) was significant at the 0.0081 level at the cutoff date of this report.|one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|The study was designed to test the null hypothesis H0: λ ≥1 versus the alternative hypothesis HA: λ \<1, where λ is the hazard ratio (HR; Lorlatinib/Crizotinib). Evaluation of 177 PFS events was required to have at least 90% power to detect a HR of 0.611 using a one-sided stratified log-rank test at a significance level of 0.025 (one-sided), and a 2-look group-sequential design with a Lan-DeMets (O'Brien-Fleming) α-spending function to determine the efficacy boundaries.||0.413|0.191|<0.0001
73966710|NCT03052608|147470310|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.414|1.249|||||Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||1.249|0.414|
73966711|NCT03052608|147470311|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.144|0.307|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||0.307|0.144|<0.0001
73966712|NCT03052608|147470312|SUPERIORITY||Odds Ratio (OR)|2.254||||0.0005|TWO_SIDED|95.0|1.353|3.891|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||3.891|1.353|0.0005
73971373|NCT04865289|147483261|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.48|1.21||||||||1.21|0.48|
74088410|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|0.0083|STANDARD_ERROR_OF_MEAN|0.3497||0.9812||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Black/African American is presented.||||0.9812
73860824|NCT03654885|147267666|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.79|STANDARD_ERROR_OF_MEAN|2.214||0.421|TWO_SIDED|95.0|-2.579|6.151||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed model repeated measures|||||6.151|-2.579|0.421
73860825|NCT03654885|147267667|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.25||0.18|TWO_SIDED|95.0|-0.16|0.84||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||0.84|-0.16|0.180
73860826|NCT03654885|147267668|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.7||||0.064|TWO_SIDED|95.0|-33.0|2.3|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤18 mmHg||2.3|-33.0|0.064
73860827|NCT03654885|147267668|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.3||||0.078|TWO_SIDED|95.0|-32.7|2.5|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤17 mmHg||2.5|-32.7|0.078
73860828|NCT03654885|147267668|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.4||||0.051|TWO_SIDED|95.0|-34.7|0.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤16 mmHg||0.4|-34.7|0.051
73860829|NCT03654885|147267668|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-16.9||||0.064|TWO_SIDED|95.0|-34.1|1.0|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤15 mmHg||1.0|-34.1|0.064
73860830|NCT03654885|147267668|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-13.1||||0.2|TWO_SIDED|95.0|-30.5|4.8|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤14 mm Hg||4.8|-30.5|0.200
73860831|NCT03654885|147267668|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.0||||0.042|TWO_SIDED|95.0|-37.1|-2.0|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤13 mm Hg||-2.0|-37.1|0.042
73860832|NCT03654885|147267668|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.7||||0.18|TWO_SIDED|95.0|-30.1|5.2|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤12 mm Hg||5.2|-30.1|0.180
73917741|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.11||0.417|TWO_SIDED|90.0|-1.0|2.9|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.9|-1.0|0.417
74027683|NCT00949650|147608631|SUPERIORITY_OR_OTHER|||||||0.0062||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0062
74027684|NCT00949650|147608631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.589||||0.2133||95.0|0.401|0.866|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||0.866|0.401|0.2133
74086467|NCT00292227|147726483|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.07||||||90.0|-2.14|2.28|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.28|-2.14|
73860833|NCT03654885|147267669|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-3.6||||0.712|TWO_SIDED|95.0|-21.3|14.2|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥25% IOP Reduction||14.2|-21.3|0.712
73860834|NCT03654885|147267669|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.9||||0.201|TWO_SIDED|95.0|-30.3|5.0|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥30% IOP Reduction||5.0|-30.3|0.201
73860835|NCT03654885|147267669|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.3||||0.03|TWO_SIDED|95.0|-37.3|-2.3|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥35% IOP Reduction||-2.3|-37.3|0.030
73860836|NCT03654885|147267669|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-18.8||||0.043|TWO_SIDED|95.0|-36.0|-0.8|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥40% IOP Reduction||-0.8|-36.0|0.043
73860837|NCT03654885|147267669|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.9||||0.048|TWO_SIDED|95.0|-35.1|0.0|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥45% IOP Reduction||0.0|-35.1|0.048
73860838|NCT03654885|147267669|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-21.1||||0.015|TWO_SIDED|95.0|-38.1|-3.2|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥50% IOP Reduction||-3.2|-38.1|0.015
73860839|NCT03654885|147267670|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-11.7||||0.252|TWO_SIDED|95.0|-29.0|6.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤18 mm Hg||6.3|-29.0|0.252
74027685|NCT00949650|147608632|SUPERIORITY_OR_OTHER|||||||0.0129||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0129
73917742|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.11||0.998|TWO_SIDED|90.0|-3.7|3.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.7|-3.7|0.998
73917743|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.16||0.353|TWO_SIDED|90.0|-5.8|1.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-5.8|0.353
73966713|NCT03052608|147470313|SUPERIORITY||Odds Ratio (OR)|2.499||||0.0002|TWO_SIDED|95.0|1.484|4.594|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||4.594|1.484|0.0002
73966714|NCT03052608|147470314|SUPERIORITY||Odds Ratio (OR)|8.407|||<|0.0001|TWO_SIDED|95.0|2.586|27.233|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||27.233|2.586|<0.0001
73917744|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.92||0.296|TWO_SIDED|90.0|-1.3|5.4|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||5.4|-1.3|0.296
73917745|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.95||0.841|TWO_SIDED|90.0|-1.8|1.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.5|-1.8|0.841
73966715|NCT03052608|147470315|SUPERIORITY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.026|0.17|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||0.170|0.026|<0.0001
74086468|NCT00292227|147726484|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.56||||||90.0|-2.84|1.72|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.72|-2.84|
74086469|NCT00292227|147726485|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.26||||||90.0|-2.29|1.78|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.78|-2.29|
74086470|NCT00292227|147726486|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.17||||||90.0|-3.25|0.91|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.91|-3.25|
74086471|NCT00292227|147726487|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.69||||||90.0|-0.34|3.73|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.73|-0.34|
74088411|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0663|STANDARD_ERROR_OF_MEAN|0.2314||0.7766||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Females(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.7766
73860840|NCT03654885|147267670|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-11.5||||0.258|TWO_SIDED|95.0|-28.9|6.5|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤17 mmHg||6.5|-28.9|0.258
74027686|NCT00949650|147608632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0078||95.0|0.499|0.927|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||0.927|0.499|0.0078
74027687|NCT00949650|147608633|SUPERIORITY_OR_OTHER|||||||0.1882||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.1882
73860841|NCT03654885|147267670|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-13.6||||0.139|TWO_SIDED|95.0|-30.9|4.4|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤16 mm Hg||4.4|-30.9|0.139
73860842|NCT03654885|147267670|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-14.7||||0.136|TWO_SIDED|95.0|-32.0|3.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤15 mm Hg||3.3|-32.0|0.136
73860843|NCT03654885|147267670|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.%.|Percentage Difference|-10.8||||0.274|TWO_SIDED|95.0|-28.2|7.1|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤14 mm Hg||7.1|-28.2|0.274
73860844|NCT03654885|147267670|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.7||||0.065|TWO_SIDED|95.0|-35.0|0.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤13 mm Hg||0.3|-35.0|0.065
73860845|NCT03654885|147267670|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.7||||0.18|TWO_SIDED|95.0|-30.1|5.2|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤12 mmHg||5.2|-30.1|0.180
73860846|NCT03654885|147267673|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|1.8||||1|TWO_SIDED|95.0|-41.6|44.1|||Fisher Exact|||||44.1|-41.6|1.000
73860847|NCT03654885|147267674|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-32.1||||0.215|TWO_SIDED|95.0|-66.8|10.0|||Fisher Exact|||||10.0|-66.8|0.215
73860848|NCT03654885|147267676|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-14.9||||0.144|TWO_SIDED|95.0|-32.2|3.1|||Fisher Exact|||||3.1|-32.2|0.144
73860849|NCT03654885|147267677|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-10.6||||0.254|TWO_SIDED|95.0|-28.0|7.3|||Fisher Exact|||||7.3|-28.0|0.254
73860850|NCT03654885|147267678|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-7.4||||0.563|TWO_SIDED|95.0|-28.6|14.2|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤18 mm Hg||14.2|-28.6|0.563
73860851|NCT03654885|147267678|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.5||||0.188|TWO_SIDED|95.0|-33.5|9.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤17 mm Hg||9.1|-33.5|0.188
73860852|NCT03654885|147267678|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.9||||0.118|TWO_SIDED|95.0|-36.7|5.6|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤16 mmHg||5.6|-36.7|0.118
73860853|NCT03654885|147267678|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-19.5||||0.085|TWO_SIDED|95.0|-40.2|2.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤15 mm Hg||2.1|-40.2|0.085
73860854|NCT03654885|147267678|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-21.3||||0.059|TWO_SIDED|95.0|-42.0|0.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤14 mm Hg||0.4|-42.0|0.059
73860855|NCT03654885|147267678|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-23.5||||0.045|TWO_SIDED|95.0|-43.9|-1.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤13 mm Hg||-1.4|-43.9|0.045
73860856|NCT03654885|147267678|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.8||||0.076|TWO_SIDED|95.0|-41.3|1.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤12 mm Hg||1.1|-41.3|0.076
73860857|NCT03654885|147267679|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-9.6||||0.464|TWO_SIDED|95.0|-31.0|12.1|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥ 25% IOP Reduction||12.1|-31.0|0.464
73860858|NCT03654885|147267679|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-19.8||||0.069|TWO_SIDED|95.0|-40.6|2.1|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥30% IOP Reduction||2.1|-40.6|0.069
73860859|NCT03654885|147267679|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-26.6||||0.023|TWO_SIDED|95.0|-46.9|-4.7|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥35% IOP Reduction||-4.7|-46.9|0.023
73917746|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.95||0.332|TWO_SIDED|90.0|-2.6|0.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.7|-2.6|0.332
73917747|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.81||0.359|TWO_SIDED|90.0|-0.6|2.2|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.2|-0.6|0.359
73917748|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.78||0.347|TWO_SIDED|90.0|-2.1|0.6|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.6|-2.1|0.347
73917749|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.8||0.041|TWO_SIDED|90.0|-3.2|-0.4|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||-0.4|-3.2|0.041
73917750|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.79||0.212|TWO_SIDED|90.0|-0.4|2.4|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.4|-0.4|0.212
73917751|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.69||0.954|TWO_SIDED|90.0|-1.2|1.2|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.2|-1.2|0.954
73917752|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.407|TWO_SIDED|90.0|-1.8|0.6|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.6|-1.8|0.407
73917753|NCT02310568|147363769|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.66||0.412|TWO_SIDED|90.0|-0.6|1.7|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-0.6|0.412
73917754|NCT02310568|147363770|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.45||0.856|TWO_SIDED|90.0|-2.2|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.7|-2.2|0.856
73917755|NCT02310568|147363770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.38||0.647|TWO_SIDED|90.0|-1.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.9|-1.7|0.647
73917756|NCT02310568|147363770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.817|TWO_SIDED|90.0|-3.0|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.3|-3.0|0.817
73917757|NCT02310568|147363770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.81||0.67|TWO_SIDED|90.0|-3.8|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.2|-3.8|0.670
73917758|NCT02310568|147363770|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.74||0.736|TWO_SIDED|90.0|-2.3|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.5|-2.3|0.736
73917759|NCT02310568|147363770|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.99||0.496|TWO_SIDED|90.0|-4.7|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.0|-4.7|0.496
73917760|NCT02310568|147363770|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.72||0.575|TWO_SIDED|90.0|-1.9|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.8|-1.9|0.575
73917761|NCT02310568|147363770|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.67||0.362|TWO_SIDED|90.0|-1.2|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||4.3|-1.2|0.362
73917762|NCT02310568|147363770|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.9||0.771|TWO_SIDED|90.0|-3.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.6|-3.7|0.771
73917763|NCT02310568|147363771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.45|1.26|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||1.26|0.45|
73917764|NCT02310568|147363771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|90.0|0.23|1.54|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||1.54|0.23|
73917765|NCT02310568|147363771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|90.0|0.69|2.32|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||2.32|0.69|
73917766|NCT02310568|147363771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24|||||TWO_SIDED|90.0|0.27|5.78|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||5.78|0.27|
73966716|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|4.65||||0.0096|TWO_SIDED|95.0|1.14|8.16|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Global QOL. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||8.16|1.14|0.0096
73966717|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|2.02||||0.1897|TWO_SIDED|95.0|-1.01|5.05|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Physical Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.05|-1.01|0.1897
73966718|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|2.09||||0.2999|TWO_SIDED|95.0|-1.87|6.04|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Role Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||6.04|-1.87|0.2999
74027688|NCT00949650|147608633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.826||||0.0427||95.0|0.618|1.104|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||1.104|0.618|0.0427
74027689|NCT01852344|147608641|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||0.159
73966719|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|2.58||||0.0553|TWO_SIDED|95.0|-0.06|5.22|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Emotional Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.22|-0.06|0.0553
73966720|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|-3.18||||0.0588|TWO_SIDED|95.0|-6.47|0.12|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Cognitive Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.12|-6.47|0.0588
73917767|NCT02310568|147363771|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.13|||||TWO_SIDED|90.0|0.19|24.51|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||24.51|0.19|
73917768|NCT02310568|147363771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|90.0|0.16|2.09|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||2.09|0.16|
73966721|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|2.27||||0.2118|TWO_SIDED|95.0|-1.3|5.85|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Social Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.85|-1.30|0.2118
74027690|NCT01852344|147608641|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||0.159
74027691|NCT01852344|147608642|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||||||0.236
74027692|NCT01852344|147608643|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
74027693|NCT00069121|147608666|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0038|TWO_SIDED|95.0|0.69|0.93||This test used a two-sided significance level of 5%.|Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.93|0.69|0.0038
73860860|NCT03654885|147267679|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-23.7||||0.046|TWO_SIDED|95.0|-43.9|-1.6|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥40% IOP Reduction||-1.6|-43.9|0.046
73860861|NCT03654885|147267679|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-27.6||||0.014|TWO_SIDED|95.0|-47.6|-5.9|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥45% IOP Reduction||-5.9|-47.6|0.014
73860862|NCT03654885|147267679|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-30.9||||0.006|TWO_SIDED|95.0|-50.8|-9.5|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥50% IOP Reduction||-9.5|-50.8|0.006
73860863|NCT03654885|147267686|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.35||0.004|TWO_SIDED|95.0|0.33|1.72|||Mixed Model for Repeated Measures|MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses: Day 1||1.72|0.33|0.004
73860864|NCT03654885|147267686|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.36||0.001|TWO_SIDED|95.0|0.47|1.88||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 1||1.88|0.47|0.001
73860865|NCT03654885|147267686|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.36||0.162|TWO_SIDED|95.0|-0.2|1.2||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 2||1.20|-0.20|0.162
73860866|NCT03654885|147267686|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.36||0.185|TWO_SIDED|95.0|-0.23|1.19||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 1||1.19|-0.23|0.185
73860867|NCT03654885|147267686|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.36||0.846|TWO_SIDED|95.0|-0.64|0.79||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 3||0.79|-0.64|0.846
73860868|NCT03654885|147267686|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.36||0.965|TWO_SIDED|95.0|-0.73|0.7||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 6||0.70|-0.73|0.965
73860869|NCT03654885|147267686|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.37||0.096|TWO_SIDED|95.0|-0.11|1.33||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 9||1.33|-0.11|0.096
73860870|NCT03654885|147267686|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.37||0.063|TWO_SIDED|95.0|-0.04|1.43||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 12||1.43|-0.04|0.063
73860871|NCT03654885|147267687|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.027||0.048|TWO_SIDED|95.0|-0.105|0.0|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 1||0.000|-0.105|0.048
73860872|NCT03654885|147267687|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.027||0.742|TWO_SIDED|95.0|-0.062|0.045|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 3||0.045|-0.062|0.742
73966722|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|-5.67||||0.0032|TWO_SIDED|95.0|-9.42|-1.92|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Fatigue. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-1.92|-9.42|0.0032
73966723|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|-7.86|||<|0.0001|TWO_SIDED|95.0|-9.86|-5.86|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Nausea and Vomiting. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-5.86|-9.86|<0.0001
73966724|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|1.16||||0.531|TWO_SIDED|95.0|-2.49|4.82|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Pain. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||4.82|-2.49|0.5310
73966725|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|1.72||||0.3602|TWO_SIDED|95.0|-1.98|5.43|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.43|-1.98|0.3602
73966726|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|-7.95|||<|0.0001|TWO_SIDED|95.0|-11.25|-4.64|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Insomnia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-4.64|-11.25|<0.0001
73966727|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|-9.21|||<|0.0001|TWO_SIDED|95.0|-11.8|-6.62|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Appetite Loss. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-6.62|-11.80|<0.0001
73966728|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|-4.93||||0.0198|TWO_SIDED|95.0|-9.07|-0.79|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Constipation. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-0.79|-9.07|0.0198
73966729|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|-12.03|||<|0.0001|TWO_SIDED|95.0|-15.49|-8.58|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Diarrhea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-8.58|-15.49|<0.0001
74027694|NCT00069121|147608667|OTHER|Descriptive analysis only.|Hazard Ratio (HR)|0.78||||0.0015|TWO_SIDED|95.0|0.67|0.91|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.91|0.67|0.0015
73860873|NCT03654885|147267687|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.027||0.925|TWO_SIDED|95.0|-0.056|0.051|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 6||0.051|-0.056|0.925
73860874|NCT03654885|147267687|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.028||0.021|TWO_SIDED|95.0|-0.118|-0.01|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 12||-0.010|-0.118|0.021
73860875|NCT03654885|147267690|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.562|STANDARD_ERROR_OF_MEAN|0.3231||0.087|TWO_SIDED|95.0|-1.2082|0.0851|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Week 1||0.0851|-1.2082|0.087
73860876|NCT03654885|147267690|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.3355||0.682|TWO_SIDED|95.0|-0.809|0.5324|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 1||0.5324|-0.8090|0.682
73860877|NCT03654885|147267690|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.452|STANDARD_ERROR_OF_MEAN|0.3484||0.199|TWO_SIDED|95.0|-1.1483|0.2434|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 12||0.2434|-1.1483|0.199
73860878|NCT03654885|147267691|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.001|STANDARD_ERROR_OF_MEAN|0.2026||0.997|TWO_SIDED|95.0|-0.4103|0.4086|||Mixed Model for Repeated Measures|||Mean Change in Optical Biometry - Anterior Chamber Depth at Day 1||0.4086|-0.4103|0.997
73860879|NCT03654885|147267691|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.222|STANDARD_ERROR_OF_MEAN|0.2124||0.302|TWO_SIDED|95.0|-0.2068|0.6506|||Mixed Model for Repeated Measures|||Mean Change in Optical Biometry - Anterior Chamber Depth at Week 2||0.6506|-0.2068|0.302
73860880|NCT03654885|147267692|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.343|STANDARD_ERROR_OF_MEAN|0.3336||0.309|TWO_SIDED|95.0|-0.3289|1.0154|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K1 at Day 1||1.0154|-0.3289|0.309
73860881|NCT03654885|147267692|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.261|STANDARD_ERROR_OF_MEAN|0.3278||0.43|TWO_SIDED|95.0|-0.3993|0.922|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K1 at Week 2||0.9220|-0.3993|0.430
73860882|NCT03654885|147267692|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.409|STANDARD_ERROR_OF_MEAN|0.4457||0.363|TWO_SIDED|95.0|-1.3071|0.4882|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K2 at Day 1||0.4882|-1.3071|0.363
73860883|NCT03654885|147267692|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.488|STANDARD_ERROR_OF_MEAN|0.4383||0.272|TWO_SIDED|95.0|-1.3709|0.3954|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K2 at Week 2||0.3954|-1.3709|0.272
73860884|NCT03654885|147267692|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.765|STANDARD_ERROR_OF_MEAN|0.4502||0.096|TWO_SIDED|95.0|-1.6722|0.142|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - Delta D at Day 1||0.1420|-1.6722|0.096
74027695|NCT00069121|147608669|OTHER|Descriptive analysis only.|Hazard Ratio (HR)|0.83||||0.0367|TWO_SIDED|95.0|0.7|0.99|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.99|0.70|0.0367
74027696|NCT01832961|147608671|OTHER||||||<|0.05|||||||Friedman's Test|Friedman's test followed by Dunn's multiple comparison||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect of size used to calculate responsiveness and classified as small (0.2), moderate (0.5) and large (0.8).|||<0.05
74027697|NCT01832961|147608672|OTHER||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)|||<0.05
74088412|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.2929|STANDARD_ERROR_OF_MEAN|0.2508||0.2492||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Males(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2492
73860885|NCT03654885|147267692|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.576|STANDARD_ERROR_OF_MEAN|0.4411||0.198|TWO_SIDED|95.0|-1.4655|0.3129|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - Delta D at Week 2||0.3129|-1.4655|0.198
73860886|NCT03654885|147267703|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-3.031|STANDARD_ERROR_OF_MEAN|4.3331||0.485|TWO_SIDED|95.0|-11.5597|5.4973|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Score||5.4973|-11.5597|0.485
73860887|NCT03654885|147267703|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-10.507|STANDARD_ERROR_OF_MEAN|4.5666||0.022|TWO_SIDED|95.0|-19.5|-1.5144|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Score||-1.5144|-19.5000|0.022
73860888|NCT03654885|147267703|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-7.528|STANDARD_ERROR_OF_MEAN|4.0382||0.064|TWO_SIDED|95.0|-15.4841|0.4275|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Total Bothersome Score||0.4275|-15.4841|0.064
73860889|NCT03654885|147267703|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42||0.278|TWO_SIDED|95.0|-1.28|0.37|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Frequency Score||0.37|-1.28|0.278
73860890|NCT03654885|147267703|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.63||0.007|TWO_SIDED|95.0|-2.96|-0.47|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Frequency Score||-0.47|-2.96|0.007
73860891|NCT03654885|147267704|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.534|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Not at all||||0.534
73860892|NCT03654885|147267704|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.263|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Somewhat||||0.263
73860893|NCT03654885|147267704|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||1|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Moderately so||||1.000
73860894|NCT03654885|147267704|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.018|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Mostly||||0.018
73860895|NCT03654885|147267704|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.35|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Completely||||0.350
73860896|NCT03654885|147267704|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.264|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Missing||||0.264
73860897|NCT03654885|147267705|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-8.303|STANDARD_ERROR_OF_MEAN|16.1445||0.61|TWO_SIDED|95.0|-40.8681|24.2624|||Mixed Model for Repeated Measures|||PRO: Percent Change From Baseline in Work Productivity and Activity Impairment- Percent Overall Work Impairment Due to Health||24.2624|-40.8681|0.610
73860898|NCT03654885|147267706|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|8.33||0.097|TWO_SIDED|95.0|-30.32|2.52|||Mixed Model for Repeated Measures|||PRO: Percent Change From Baseline in Work Productivity and Activity Impairment-Percent Activity Impairment Due to Health||2.52|-30.32|0.097
74027698|NCT01832961|147608673|OTHER||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)|||<0.05
74027699|NCT01832961|147608674|OTHER||||||<|0.05|||||||T-test|T-test was used to comparisons before and after FeNO results||||||<0.05
74027700|NCT01832961|147608675|OTHER||||||<|0.05|||||||T-test|||||||<0.05
74027701|NCT03037905|147608704|SUPERIORITY||Mean Difference (Final Values)|-6.7||||0.2|TWO_SIDED|95.0|-17.1|3.7|||Mixed Models Analysis|||||3.7|-17.1|0.20
73966730|NCT03052608|147470330|SUPERIORITY||Mean Difference (Net)|-1.04||||0.5947|TWO_SIDED|95.0|-4.9|2.82|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Financial Difficulties. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||2.82|-4.90|0.5947
73917769|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.801|TWO_SIDED|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.4|0.801
73917770|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.416|TWO_SIDED|90.0|-0.5|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.5|0.416
73966731|NCT03052608|147470331|SUPERIORITY||Mean Difference (Net)|0.55||||0.7254|TWO_SIDED|95.0|-2.51|3.6|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.60|-2.51|0.7254
73966732|NCT03052608|147470331|SUPERIORITY||Mean Difference (Net)|-4.55||||0.0115|TWO_SIDED|95.0|-8.06|-1.03|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Coughing. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-1.03|-8.06|0.0115
73917771|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.634|TWO_SIDED|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.3|0.634
73917772|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.47|TWO_SIDED|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.6|0.470
73917773|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.683|TWO_SIDED|90.0|-0.5|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.5|0.683
73917774|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.775|TWO_SIDED|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.5|0.775
73917775|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.848|TWO_SIDED|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.4|0.848
73917776|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.23||0.49|TWO_SIDED|90.0|-0.2|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-0.2|0.490
73917777|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.433|TWO_SIDED|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.7|0.433
73917778|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.796|TWO_SIDED|90.0|-0.4|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.4|0.796
73966733|NCT03052608|147470331|SUPERIORITY||Mean Difference (Net)|0.12||||0.7824|TWO_SIDED|95.0|-0.75|0.99|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Haemoptysis. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.99|-0.75|0.7824
73966734|NCT03052608|147470331|SUPERIORITY||Mean Difference (Net)|1.16||||0.2988|TWO_SIDED|95.0|-1.04|3.36|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Sore Mouth. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.36|-1.04|0.2988
74027702|NCT03037905|147608705|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.6|TWO_SIDED|95.0|-5.9|10.3|||Mixed Models Analysis|||||10.3|-5.9|0.60
73917779|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.624|TWO_SIDED|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.3|0.624
73966735|NCT03052608|147470331|SUPERIORITY||Mean Difference (Net)|-1.51||||0.1916|TWO_SIDED|95.0|-3.79|0.76|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Dysphagia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.76|-3.79|0.1916
73966736|NCT03052608|147470331|SUPERIORITY||Mean Difference (Net)|5.37||||0.0279|TWO_SIDED|95.0|0.59|10.15|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Peripheral Neuropathy. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||10.15|0.59|0.0279
74027703|NCT03037905|147608706|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.76|TWO_SIDED|95.0|-7.0|5.1|||Mixed Models Analysis|||||5.1|-7.0|.76
74027704|NCT03037905|147608707|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||.83
74027705|NCT01821677|147608736|SUPERIORITY|||||||0.16|||||||ANCOVA|||||||0.16
73860899|NCT02210832|147267718|SUPERIORITY|38.27% vs. 9.09%|||||<|0.001||||||p value is not adjusted for multiple comparisons. A priori threshold for significance was P \< 0.05.|Chi-squared|chi square test statistic = 20.23, df = 1||Hypothesized that women assigned to Best practices plus financial incentives would achieve greater abstinence than women assigned to Best practices only.||||<0.001
73860900|NCT02210832|147267719|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|Used generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||||||<0.05
73860901|NCT02210832|147267719|SUPERIORITY|||||||0.003||||||chi square test statistic = 21.93, df=7|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Trial condition by assessment time interaction||||0.003
73860902|NCT02210832|147267720|SUPERIORITY|||||||0.48||||||chi square test statistic = 9.52, df = 10|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Interaction of trial condition and time||||0.48
73860903|NCT02210832|147267721|SUPERIORITY||||||<|0.0001||||||chi square test statistic = 33.51, df = 2|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Examining main effect of treatment condition.||||<0.0001
73860904|NCT02210832|147267721|SUPERIORITY|||||||0.89||||||chi square test statistic = 5.00, df = 10.|Mixed Models Analysis|||Testing interaction of treatment condition and assessment time||||0.89
73860905|NCT02210832|147267722|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||<0.001
73860906|NCT02210832|147267723|SUPERIORITY||||||<|0.001||||||F\[7,922\]=3.62|ANCOVA|Repeated measures analysis of covariance was conducted with Bonferroni corrections for post-doc tests and across repeated assessments.||Examine interaction of treatment condition and assessment time.||||<0.001
73860907|NCT02210832|147267723|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||<0.001
73860908|NCT02210832|147267724|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||0.009
73860909|NCT02210832|147267725|SUPERIORITY|||||||0.01|||||||Regression, Logistic|Method is logistic regression adjusted for covariates.||||||0.01
74027706|NCT01821677|147608736|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
73860910|NCT02210832|147267726|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
73860911|NCT02210832|147267727|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
73860912|NCT02210832|147267729|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
74027707|NCT01821677|147608736|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
73860913|NCT02210832|147267733|SUPERIORITY|||||||0.006|||||||ANCOVA|All comparisons adjusted for infant gestational age at time of delivery.||||||0.006
73860914|NCT02080260|147267748|SUPERIORITY||16-week PFS Rate|0.1||||0.824|TWO_SIDED|95.0|0.012|0.317||This p-value is only based on partial enrollment of the study. The study enrollment was stopped early due to futility.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|The null hypothesis assumes a median PFS of 6 weeks, corresponding to a 16-week PFS rate of approximately 0.15. A single-stage design will be used to test that the 16-week PFS rate is less than or equal to 0.15. If at least 8 of the 32 subjects are alive and progression free at 16 weeks, the null hypothesis will be rejected. Assuming a one-sided alpha = 0.10 significance level, this will provide at least 90% power to reject the null hypothesis, assuming the true 16-week PFS rate is 0.35.||0.317|0.012|0.824
73860915|NCT02080260|147267749|OTHER|Estimation only.|Median|6.1|||||TWO_SIDED|95.0|2.9|7.1|||||The Kaplan Meier method was used to estimate the median PFS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||7.1|2.9|
73860916|NCT02080260|147267750|OTHER|Estimation only.|Median|9.4|||||TWO_SIDED|95.0|8.1|17.0|||||The Kaplan Meier method was used to estimate the median OS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||17.0|8.1|
74027708|NCT01821677|147608737|SUPERIORITY|||||||0.42|||||||ANCOVA|||||||0.42
74027709|NCT01821677|147608737|SUPERIORITY|||||||0.28|||||||ANCOVA|||||||0.28
74027710|NCT01821677|147608737|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
74027711|NCT01894516|147608738|SUPERIORITY||Difference in percentage rates|37.5|||<|0.0001|TWO_SIDED|95.0|22.4|52.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||52.6|22.4|< 0.0001
74027712|NCT01894516|147608738|SUPERIORITY||Difference in percentage rates|36.5|||<|0.0001|TWO_SIDED|95.0|21.3|51.8||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||51.8|21.3|< 0.0001
73966737|NCT03052608|147470331|SUPERIORITY||Mean Difference (Net)|-0.2||||0.9162|TWO_SIDED|95.0|-3.89|3.49|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Alopecia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.49|-3.89|0.9162
73966738|NCT03052608|147470331|SUPERIORITY||Mean Difference (Net)|-0.53||||0.6698|TWO_SIDED|95.0|-2.96|1.9|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Chest. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||1.90|-2.96|0.6698
73966739|NCT03052608|147470331|SUPERIORITY||Mean Difference (Net)|0.45||||0.8035|TWO_SIDED|95.0|-3.13|4.04|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Arm or Shoulder. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||4.04|-3.13|0.8035
73966740|NCT03052608|147470331|SUPERIORITY||Mean Difference (Net)|3.36||||0.1143|TWO_SIDED|95.0|-0.82|7.55|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Other Parts. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||7.55|-0.82|0.1143
73966741|NCT03052608|147470334|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7293|TWO_SIDED|95.0|0.822|1.444|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||1.444|0.822|0.7293
73966742|NCT04204278|147470339|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
73966743|NCT04204278|147470340|OTHER||||||<|0.0001|||||||t-test, 1 sided|P-Value was calculated||||||<0.0001
73966744|NCT04204278|147470341|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
73966745|NCT05249439|147470344|OTHER|Paired t-test|Mean Difference (Final Values)|-12.99|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||I-SatPro starting weight Vs 52 week weight (kg)||||<0.0001
73966746|NCT03526861|147470356|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|13.8||||0.002|TWO_SIDED|95.0|5.3|22.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||22.3|5.3|0.002
73966747|NCT03526861|147470356|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|95.0|8.4|26.6||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||26.6|8.4|<0.001
73966748|NCT03526861|147470357|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|22.0|||<|0.001|TWO_SIDED|95.0|12.0|32.0||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.0|12.0|<0.001
73966749|NCT03526861|147470357|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|12.4|32.6||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.6|12.4|<0.001
73966750|NCT03526861|147470358|SUPERIORITY|Secondary endpoint tested sequentially at a 2.5% significance level|Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|12.3|31.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||31.1|12.3|<0.001
73971374|NCT04865289|147483262|NON_INFERIORITY|The null hypothesis for the non-inferiority test was that the hazard ratio was equal to 1.1.|Hazard Ratio (HR)|1.17||||0.5831415|TWO_SIDED|95.0|0.64|2.15|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||2.15|0.64|0.5831415
73917780|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.844|TWO_SIDED|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.5|0.844
73917781|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.5||0.743|TWO_SIDED|90.0|-0.7|1.0|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.7|0.743
73917782|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.356|TWO_SIDED|90.0|-1.3|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-1.3|0.356
73917783|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.45||0.18|TWO_SIDED|90.0|-0.2|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-0.2|0.180
73917784|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.589|TWO_SIDED|90.0|-0.6|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.2|-0.6|0.589
73917785|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.873|TWO_SIDED|90.0|-0.8|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.8|0.873
73917786|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.48||0.667|TWO_SIDED|90.0|-0.6|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.6|0.667
73917787|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.47||0.548|TWO_SIDED|90.0|-0.5|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-0.5|0.548
73917788|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.567|TWO_SIDED|90.0|-1.0|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-1.0|0.567
73917789|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.42||0.208|TWO_SIDED|90.0|-0.2|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.2|0.208
73917790|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.858|TWO_SIDED|90.0|-1.2|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-1.2|0.858
74088413|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coeffcient|-0.316|STANDARD_ERROR_OF_MEAN|0.1826||0.0877||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(Normal and Underweight (\<25.0) vs. Overweight and Obsese (\>= 25.0)) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0877
73917791|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.329|TWO_SIDED|90.0|-1.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-1.7|0.329
73917792|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.54||0.272|TWO_SIDED|90.0|-0.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.4|0.272
73917793|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.33||0.946|TWO_SIDED|90.0|-0.6|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.5|-0.6|0.946
73917794|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.407|TWO_SIDED|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.3|-0.8|0.407
74088414|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0292|STANDARD_ERROR_OF_MEAN|0.0113||0.0117||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(continuous variable) on vaccine response as measured in log10 titers.||||0.0117
73917795|NCT02310568|147363772|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.31||0.436|TWO_SIDED|90.0|-0.3|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.8|-0.3|0.436
73917796|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.325|TWO_SIDED|90.0|-0.6|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.1|-0.6|0.325
73917797|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.996|TWO_SIDED|90.0|-0.3|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.3|0.996
73917798|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.377|TWO_SIDED|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.6|0.377
73917799|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.291|TWO_SIDED|90.0|-0.7|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.1|-0.7|0.291
73917800|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.925|TWO_SIDED|90.0|-0.4|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.4|0.925
73917801|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.39|TWO_SIDED|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.7|0.390
73917802|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.502|TWO_SIDED|90.0|-0.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.7|0.502
73917803|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.29||0.348|TWO_SIDED|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-0.2|0.348
73917804|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.33||0.16|TWO_SIDED|90.0|-1.0|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.1|-1.0|0.160
73917805|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.965|TWO_SIDED|90.0|-0.5|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.5|0.965
73917806|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.389|TWO_SIDED|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-0.2|0.389
73917807|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.34||0.433|TWO_SIDED|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.8|0.433
73971375|NCT04865289|147483262|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6980186|TWO_SIDED|95.0|0.64|1.26|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||1.26|0.64|0.6980186
73971376|NCT04865289|147483263|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.52046|TWO_SIDED|95.0|0.57|1.8|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||1.80|0.57|0.52046
73917808|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.94|TWO_SIDED|90.0|-0.9|0.8|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.8|-0.9|0.940
73917809|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.757|TWO_SIDED|90.0|-1.0|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-1.0|0.757
73917810|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.836|TWO_SIDED|90.0|-0.7|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-0.7|0.836
73917811|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.827|TWO_SIDED|90.0|-0.9|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-0.9|0.827
73966751|NCT03526861|147470358|SUPERIORITY|Secondary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|19.9|||<|0.001|TWO_SIDED|95.0|10.6|29.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||29.2|10.6|<0.001
73971377|NCT04865289|147483264|OTHER||Difference in Percentage|-10.5||||0.8497|TWO_SIDED|95.0|-29.2|9.3|||Miettinen & Nurminen|One sided p value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.||||9.3|-29.2|0.8497
74086472|NCT00292227|147726488|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.31||||||90.0|-1.7|2.32|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.32|-1.70|
74088415|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0578|STANDARD_ERROR_OF_MEAN|0.2163||0.7899||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of smokng cigarettes(Never Smoked vs. Has Smoked) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.7899
73971378|NCT04865289|147483265|OTHER||Difference in Percentage|-9.1||||0.8522|TWO_SIDED|95.0|-25.5|8.0|||Miettinen & Nurminen|One sided p value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.||||8.0|-25.5|0.8522
73971379|NCT04865289|147483266|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction.|Difference in Least Square Means|-2.14||||0.6138|TWO_SIDED|95.0|-10.54|6.27|||cLDA model|||||6.27|-10.54|0.6138
73971380|NCT04865289|147483267|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction.|Difference in Least Square Means|-0.73||||0.8398|TWO_SIDED|95.0|-7.93|6.46|||cLDA model|||||6.46|-7.93|0.8398
73971381|NCT06201559|147483272|EQUIVALENCE|Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for Cmax following replicate administrations of the comparator product was \> 30%, the acceptance criteria for Cmax was widened to a maximum of 69.84-143.19%.|Ratio of Geometric Least Square Means|98.1|||||TWO_SIDED|90.0|86.79|110.91|||||Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.|||110.91|86.79|
73971382|NCT06201559|147483273|EQUIVALENCE|Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for AUC(0-t) following replicate administrations of the comparator product was \> 30%, the acceptance criteria for AUC(0-t) was widened to a maximum of 69.84-143.19%.|Ratio of Geometric Least Square Means|97.6|||||TWO_SIDED|90.0|86.86|109.73|||||Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.|||109.73|86.86|
73971383|NCT02561247|147483288|OTHER|||||||0.0008||||||P Value is from a one sample t-test compared against the null hypothesis value|t-test, 1 sided|Null Hypothesis Value = -38; Degrees of Freedom=16; t-value=-4.13||P Value is from a one sample t-test compared against the null hypothesis value. No adjustments were made for multiple comparisons/multiplicity in this study, since there was only one primary endpoint, one arm, and one pre-specified primary null hypothesis.||||0.0008
73971384|NCT04248725|147483341|SUPERIORITY||Mean Difference (Net)|-2.7||||0.004|TWO_SIDED||||||Mixed Models Analysis|Models were adjusted for sex, baseline severity, and disability condition.||||||0.004
73971385|NCT04248725|147483342|SUPERIORITY||Mean Difference (Net)|0.59|||<|0.001|TWO_SIDED|95.0|0.3|0.88|||Mixed Models Analysis|||||0.88|0.30|<0.001
73971386|NCT04248725|147483343|SUPERIORITY||Mean Difference (Net)|-0.32||||0.29|TWO_SIDED|95.0|-0.61|-0.03|||Mixed Models Analysis|||||-0.03|-0.61|0.29
73971387|NCT03656510|147483385|OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.382|0.185||||||Difference versus placebo in mean RSV viral load AUC on Day 3||0.185|-1.382|
73971388|NCT03656510|147483385|OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-1.19|0.418||||||Difference versus placebo in mean RSV viral load AUC on Day 3||0.418|-1.190|
73971389|NCT03656510|147483385|OTHER||Mean Difference (Final Values)|-2.46|||||TWO_SIDED|95.0|-4.674|-0.25||||||Difference versus placebo in mean RSV viral load AUC on Day 8||-0.250|-4.674|
73971390|NCT03656510|147483385|OTHER||Mean Difference (Final Values)|-2.38|||||TWO_SIDED|95.0|-4.645|-0.114||||||Difference versus placebo in mean RSV viral load AUC on Day 8||-0.114|-4.645|
73971391|NCT05312008|147483431|SUPERIORITY||||||<|0.6|||||||t-test, 2 sided|paired||||||<0.6
73971392|NCT05312008|147483432|SUPERIORITY||||||<|0.6|||||||t-test, 2 sided|Paired||||||<0.6
73971393|NCT05312008|147483433|SUPERIORITY||||||<|1|||||||t-test, 2 sided|Paired||||||<1
73971394|NCT05312008|147483434|SUPERIORITY||||||<|0.04|||||||t-test, 2 sided|Paired||||||<0.04
73971395|NCT05312008|147483435|SUPERIORITY||||||<|0.5|||||||t-test, 2 sided|Paired||||||<0.5
73966752|NCT03526861|147470359|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-19.7|||<|0.001|TWO_SIDED|95.0|-27.1|-12.2||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-12.2|-27.1|<0.001
73860917|NCT02080260|147267751|OTHER|Estimation only|Overall Response Rate|0.05|||||TWO_SIDED|95.0|0.001|0.249|||||Confidence interval estimated using the Clopper Pearson method.|||0.249|0.001|
73860918|NCT02080260|147267752|OTHER|Estimation only.|Disease Control Rate|0.3|||||TWO_SIDED|95.0|0.119|0.543|||||Confidence interval estimated using the Clopper Pearson method.|||0.543|0.119|
73860919|NCT00628589|147267764|SUPERIORITY|LS mean was used in the primary efficacy analysis||||||0.0004|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model||||||0.0004
73860920|NCT00628589|147267764|SUPERIORITY||||||<|0.0001|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model||||||<0.0001
73860921|NCT00628589|147267765|SUPERIORITY|||||||0.0015|||||||Fisher Exact|||||||0.0015
73860922|NCT00628589|147267765|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73860923|NCT00628589|147267766|SUPERIORITY|||||||0.0015|||||||Fisher Exact|||||||0.0015
73860924|NCT00628589|147267766|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73860925|NCT01030874|147267767|OTHER||Odds Ratio (OR)|1.16||||0.6|TWO_SIDED|95.0|0.67|1.99|||Regression, Logistic|Adjusted for whether patient had orthostatic hypotension at baseline.|Arm 2 is in the numerator of OR calculation.|||1.99|0.67|0.6
73860926|NCT01030874|147267768|OTHER||Odds Ratio (OR)|1.53||||0.3|TWO_SIDED|95.0|0.74|3.24|||Regression, Logistic|Adjusted for whether patient had orthostatic hypotension at discharge.|Arm 2 is in the numerator of OR calculation.|||3.24|0.74|0.3
73860927|NCT03883113|147267821|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||||||0.1711
73860928|NCT03883113|147267821|OTHER|||||||0.1654|||||||Wilcoxon (Mann-Whitney)|||||||0.1654
73860929|NCT03883113|147267821|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||||||0.1711
73860930|NCT03883113|147267822|OTHER|||||||1|||||||Fisher Exact|||The statistical analysis applies to participants with Virologically confirmed Influenza-like Illness versus participants without Virologically confirmed Influenza-like Illness||||1.000
73860931|NCT03883113|147267823|OTHER|||||||0.143|||||||Fisher Exact|||This statistical analysis applies to participants with qPCR confirmed Influenza versus participants with no qPCR confirmed Influenza||||0.143
73860932|NCT03883113|147267824|OTHER|||||||0.3504|||||||Fisher Exact|||This statistical analysis applies to participants with qCulture confirmed Influenza versus participants without qCulture confirmed Influenza||||0.3504
73860933|NCT03883113|147267825|OTHER|||||||0.5558|||||||Log Rank|||||||0.5558
73860934|NCT03883113|147267826|OTHER|||||||0.6534|||||||Log Rank|||||||0.6534
73860935|NCT03883113|147267827|OTHER|||||||0.5485|||||||Wilcoxon (Mann-Whitney)|||||||0.5485
73860936|NCT03883113|147267828|OTHER|||||||0.6753|||||||Wilcoxon (Mann-Whitney)|||||||0.6753
73860937|NCT03883113|147267829|OTHER|||||||0.711|||||||Log Rank|||||||0.711
73860938|NCT03883113|147267830|OTHER|||||||0.4689|||||||Log Rank|||||||0.4689
73860939|NCT03883113|147267833|OTHER|||||||0.5001|||||||Wilcoxon (Mann-Whitney)|||||||0.5001
73860940|NCT03883113|147267834|OTHER|||||||0.6799|||||||zero-inflated poisson model|||||||0.6799
73860941|NCT03883113|147267835|OTHER|||||||0.5911|||||||Wilcoxon (Mann-Whitney)|||||||0.5911
73860942|NCT01457950|147267843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21|||<|0.0001|TWO_SIDED|95.0|2.06|4.36|||ANCOVA|||||4.36|2.06|<0.0001
73860943|NCT02498067|147267882|OTHER|||||||0.177||||||a priori threshold for statistical significance: p\<0.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants' mean reported scores for frequency of dual method use differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.177
73860944|NCT02498067|147267883|OTHER|||||||0.318||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants' mean reported scores for frequency of condom use alone (without another method) differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.318
73860945|NCT02498067|147267884|OTHER|||||||0||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants reported more consistent contraceptive use (i.e., using contraception every time they had sex) between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.000
73860946|NCT02498067|147267886|OTHER|||||||0.03||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use an IUD in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.030
73860947|NCT02498067|147267887|OTHER|||||||0.14||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use an implant in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.140
73860948|NCT02498067|147267888|OTHER|||||||0.315||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use condoms in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.315
73860949|NCT02498067|147267889|OTHER|||||||0.028||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported contraceptive self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan||||.028
73860950|NCT02498067|147267890|OTHER|||||||0.918||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported condom use self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan||||.918
73860951|NCT02498067|147267892|OTHER|||||||0.209||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' self-reported number of sexual partners in the past 3 months (for those were sexually active) between baseline and 3-month follow-up||||.209
73917812|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.507|TWO_SIDED|90.0|-0.6|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.6|0.507
73917813|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.51||0.632|TWO_SIDED|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-1.1|0.632
73917814|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.51||0.442|TWO_SIDED|90.0|-0.5|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.5|0.442
73917815|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.643|TWO_SIDED|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-1.1|0.643
73917816|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.47||0.188|TWO_SIDED|90.0|-0.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.2|0.188
73917817|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.701|TWO_SIDED|90.0|-1.4|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-1.4|0.701
73917818|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.63||0.271|TWO_SIDED|90.0|-1.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-1.8|0.271
73917819|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.6||0.445|TWO_SIDED|90.0|-0.6|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.6|0.445
73917820|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.714|TWO_SIDED|90.0|-0.8|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.5|-0.8|0.714
73966753|NCT03526861|147470359|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-18.0|||<|0.001|TWO_SIDED|95.0|-25.6|-10.4||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-10.4|-25.6|<0.001
73966754|NCT03526861|147470360|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-2.6||||0.007|TWO_SIDED|95.0|-4.5|-0.7||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.7|-4.5|0.007
73917821|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.35||0.515|TWO_SIDED|90.0|-0.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.4|-0.8|0.515
73917822|NCT02310568|147363773|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.778|TWO_SIDED|90.0|-0.5|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.7|-0.5|0.778
73917823|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.93||0.562|TWO_SIDED|90.0|-2.1|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-2.1|0.562
73917824|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.92||0.708|TWO_SIDED|90.0|-1.9|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.2|-1.9|0.708
73917825|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05||0.852|TWO_SIDED|90.0|-1.9|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-1.9|0.852
73917826|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.14||0.347|TWO_SIDED|90.0|-3.0|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.8|-3.0|0.347
73917827|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.14||0.759|TWO_SIDED|90.0|-2.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-2.2|0.759
73917828|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.28||0.574|TWO_SIDED|90.0|-2.9|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-2.9|0.574
73917829|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.09||0.831|TWO_SIDED|90.0|-2.1|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-2.1|0.831
73917830|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.1||0.705|TWO_SIDED|90.0|-1.4|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-1.4|0.705
73917831|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.24||0.6|TWO_SIDED|90.0|-2.7|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-2.7|0.600
73917832|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.23||0.848|TWO_SIDED|90.0|-2.3|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.8|-2.3|0.848
73917833|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.24||0.237|TWO_SIDED|90.0|-0.6|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.5|-0.6|0.237
73917834|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.4||0.224|TWO_SIDED|90.0|-4.0|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-4.0|0.224
73917835|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.38||0.747|TWO_SIDED|90.0|-1.9|2.8|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.8|-1.9|0.747
73917836|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.37||0.764|TWO_SIDED|90.0|-2.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28). Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-2.8|0.764
73966755|NCT03526861|147470360|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-2.0||||0.04|TWO_SIDED|95.0|-3.9|-0.1||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.1|-3.9|0.040
73917837|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.22||0.487|TWO_SIDED|90.0|-1.3|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.0|-1.3|0.487
73971396|NCT03819153|147483438|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0001|TWO_SIDED|95.0|0.66|0.88|||Regression, Cox|||Time from randomization to first composite renal event was analyzed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by use of sodium glucose cotransporter-2 (SGLT-2) inhibitor (yes/no) at baseline. Based on the available number of events for analysis, the nominal significance level was updated to 0.01612 using the Lan-DeMets alpha spending function. eGFR was calculated using the CKD-EPI formula.||0.88|0.66|0.0001
73917838|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.53||0.744|TWO_SIDED|90.0|-2.1|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.2|-2.1|0.744
73860952|NCT02498067|147267893|OTHER|||||||0.652||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported degree to which they endorse negative condom attitudes (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan||||.652
73860953|NCT02498067|147267894|OTHER|||||||0.498||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported degree to which they endorse positive motivators for condom use (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan||||.498
73860954|NCT02498067|147267895|OTHER|||||||0.977||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' rated importance of negative contraceptive attitudes on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan||||.977
73860955|NCT02498067|147267896|OTHER|||||||0.673||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' rated importance of positive motivators for contraceptive use on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan||||.673
73860956|NCT02498067|147267897|OTHER|||||||0.049||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of proportion of participants who provided correct answers to whether pills or condoms are more effective at preventing pregnancy, before and 3 months after engaging in rPlan||||.049
73860957|NCT02498067|147267897|OTHER|||||||0.265||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of proportion of participants who provided correct answers to whether the IUD or shot is more effective at preventing pregnancy, before and 3 months after engaging in rPlan||||.265
73860958|NCT02337530|147267898|SUPERIORITY||Odds Ratio (OR)|1.37||||0.73|TWO_SIDED|95.0|0.28|7.01|||Fisher Exact|||||7.01|0.28|0.73
73860959|NCT02337530|147267898|SUPERIORITY||Odds Ratio (OR)|6.4||||0.01|TWO_SIDED|95.0|1.65|24.8|||Fisher Exact|||||24.8|1.65|0.01
73860960|NCT02337530|147267899|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.56|TWO_SIDED|95.0|0.42|1.6|||Log Rank|||||1.60|0.42|0.56
73860961|NCT02337530|147267899|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.44|TWO_SIDED|95.0|0.4|1.49|||Log Rank|||||1.49|0.40|0.44
73860962|NCT03249935|147267914|SUPERIORITY|||||||||||||||||Assumptions were that 20% of enrolled chlamydia-infected males will have urethral symptoms and azithromycin treatment failures will occur in 10% of symptomatic men vs. 2% of asymptomatic men. At a one-sided 0.05 significance level with power of 0.80, a sample size of 357 evaluable males would be needed, or approximately 72 symptomatic and 285 asymptomatic males. Assuming 20% of males enrolled would be unevaluable, a total of 446 males was targeted for enrollment.|Given that the study closed early and there were only 4 treatment failures, formal hypothesis testing was not performed.|||
73860963|NCT03249935|147267915|SUPERIORITY||Odds Ratio (OR)|0.75||||0.656|TWO_SIDED|95.0|0.22|2.62|||Regression, Logistic|||Unadjusted odds ratio for age in years as a continuous variable in a logistic regression model predicting treatment failure at day 28||2.62|0.22|0.656
73860964|NCT03249935|147267915|SUPERIORITY||Odds Ratio (OR)|4.65||||0.197|TWO_SIDED|95.0|0.45|47.89|||Regression, Logistic|||Unadjusted odds ratio for reporting at baseline new partners in the last 30 days (reference group=no new partners) from a logistic model predicting treatment failure at day 28.||47.89|0.45|0.197
73860965|NCT03249935|147267915|SUPERIORITY||Odds Ratio (OR)|0.68||||0.058|TWO_SIDED|95.0|0.45|1.01|||Regression, Logistic|||Unadjusted odds ratio for Chlamydia viral load at baseline as a continuous variable in a logistic model predicting treatment failure at day 28.||1.01|0.45|0.058
73860966|NCT01229943|147267921|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.12|TWO_SIDED|95.0|0.55|1.17||Tests were stratified by: prior treatment with cytotoxic chemotherapy (no vs yes), prior use of octreotide (no vs yes), and prior therapy with sunitinib (no vs yes).|Log Rank|||Based on the log rank test, with 130 patients enrolled over 22 months and followed an additional 24 months, the difference in median PFS between 9 months and 14 months can be detected with approximately 90% power (1-sided, α=0.15).||1.17|0.55|0.12
73860967|NCT01669421|147267948|OTHER|Data was analyzed with multiple repeat ANOVA for all visits and paired samples were also evaluated.|||||<|0.05|||||||Kruskal-Wallis|||IL-2||||<0.05
73860968|NCT01669421|147267948|OTHER|Kruskal-Wallis||||||0.035|||||||Kruskal-Wallis|||IL-4||||0.035
73860969|NCT01669421|147267948|OTHER|||||||0.33|||||||Kruskal-Wallis|||IL-8||||0.33
73860970|NCT01669421|147267948|OTHER|||||||0.68|||||||Kruskal-Wallis|||IL-9||||0.68
73860971|NCT01669421|147267948|OTHER|||||||0.02|||||||Kruskal-Wallis|||IL-17||||0.020
73860972|NCT01669421|147267948|OTHER|||||||0.021|||||||Kruskal-Wallis|||FGF||||0.021
73860973|NCT01669421|147267948|OTHER|||||||0.02|||||||Kruskal-Wallis|||Eotaxin||||0.02
73860974|NCT01669421|147267948|OTHER|||||||0.045|||||||Kruskal-Wallis|||GM-CSF||||0.045
73860975|NCT01669421|147267948|OTHER|||||||0.47|||||||Kruskal-Wallis|||IL15||||0.47
73860976|NCT01669421|147267948|OTHER|||||||0.9|||||||Kruskal-Wallis|||IL-1a||||0.90
73860977|NCT01669421|147267948|OTHER|||||||0.8|||||||Kruskal-Wallis|||IL18||||0.80
73860978|NCT01669421|147267948|OTHER|||||||0.027|||||||Kruskal-Wallis|||M-CSF||||0.027
73860979|NCT01669421|147267949|OTHER|||||||0.07|||||||Kruskal-Wallis|||No power calculation and this is an exploratory pilot analysis We expected cytokines to decrease after subjects receive double dose and a rebound after administering standard dose.||||0.07
73917839|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.52||0.34|TWO_SIDED|90.0|-1.1|4.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.1|-1.1|0.340
73917840|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.36||0.477|TWO_SIDED|90.0|-3.3|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-3.3|0.477
73917841|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.51||0.482|TWO_SIDED|90.0|-1.5|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.7|-1.5|0.482
73917842|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.49||0.719|TWO_SIDED|90.0|-3.1|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-3.1|0.719
73917843|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.36||0.245|TWO_SIDED|90.0|-0.7|4.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.0|-0.7|0.245
73917844|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.93||0.586|TWO_SIDED|90.0|-2.3|4.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.4|-2.3|0.586
73966756|NCT03526861|147470363|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|38.5|||<|0.001|TWO_SIDED|95.0|26.8|50.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||50.2|26.8|<0.001
73966757|NCT03526861|147470363|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|32.4|||<|0.001|TWO_SIDED|95.0|20.6|44.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||44.1|20.6|<0.001
73966758|NCT03526861|147470364|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|13.7||||0.002|TWO_SIDED|95.0|5.2|22.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||22.2|5.2|0.002
73917845|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|1.9||0.44|TWO_SIDED|90.0|-4.8|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.8|-4.8|0.440
73917846|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.75||0.159|TWO_SIDED|90.0|-0.5|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||5.6|-0.5|0.159
73917847|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.15||0.72|TWO_SIDED|90.0|-1.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.4|-1.6|0.720
73917848|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.13||0.991|TWO_SIDED|90.0|-2.0|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.9|-2.0|0.991
73917849|NCT02310568|147363776|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.12||0.704|TWO_SIDED|90.0|-1.5|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.4|-1.5|0.704
73917850|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.82||0.539|TWO_SIDED|90.0|-0.9|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.9|-0.9|0.539
73917851|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.78||0.439|TWO_SIDED|90.0|-0.7|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.9|-0.7|0.439
73917852|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.92||0.914|TWO_SIDED|90.0|-1.6|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-1.6|0.914
73917853|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.86||0.892|TWO_SIDED|90.0|-1.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-1.3|0.892
73860980|NCT01669421|147267951|OTHER|between Week 4 and Week 8||||||0.03|||||||t-test, 2 sided|||Desmosine (DES) and isodesmosine (IDES) are used as indicator of elastin degradation. Levels of DES/IDES were measured using high-performance liquid chromatography and tandem mass spectrometry.||||0.03
73860981|NCT01669421|147267951|OTHER|||||||0.33|||||||t-test, 2 sided|||between Week 8 and Week 12||||0.33
73860982|NCT01669421|147267951|OTHER|||||||0.029|||||||Kruskal-Wallis|||between Week 4 and Week 12||||0.029
73860983|NCT00300482|147267957|SUPERIORITY_OR_OTHER||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide \>99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
73860984|NCT00300482|147267957|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide \>99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
73860985|NCT00300482|147267958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
73860986|NCT00300482|147267958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
73860987|NCT00300482|147267959|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
73860988|NCT00300482|147267959|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
73860989|NCT00882908|147267975|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|13.0||||0.051|TWO_SIDED|97.5|-1.9|28.0|||Regression, Logistic||Difference in percentages of participants in the TMC435 75mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC435 75 mg 12 and 24 week treatment groups were pooled and the percentage of participants acheiving SVRW72 were compared with the percentage of participants acheiving SVRW72 in the placebo treatment group.||28.0|-1.9|0.051
73860990|NCT00882908|147267975|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|18.9||||0.004|TWO_SIDED|97.5|4.4|33.5|||Regression, Logistic||Difference in percentages of participants in the TMC435 150mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC/PR 150 mg 12 and 24 week treatment groups were pooled and the percentage of participants achieving SVRW72 was compared the percentage of participants achieving SVRW72 in the placebo treatment group.||33.5|4.4|0.004
73860991|NCT02370095|147267991|SUPERIORITY|||||||0.2416|||||||Wilcoxon (Mann-Whitney)|||Only one placebo subject had data to allow for change from baseline to be calculated||||0.2416
73860992|NCT02370095|147267992|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|The change in S/F ratio over time was evaluated using a mixed model for repeated measures||||||0.06
73860993|NCT02370095|147267993|SUPERIORITY|||||||0.0679|||||||Wilcoxon (Mann-Whitney)|||||||0.0679
73860994|NCT02370095|147267998|SUPERIORITY|||||||0.567|||||||Mixed Models Analysis|Measurement of MAP were evaluated from baseline to end of treatment||||||0.567
73860995|NCT02370095|147267999|SUPERIORITY|||||||0.2507||||||The threshold for statistical significance was 0.05|Fisher Exact|||||||0.2507
73860996|NCT02370095|147268001|SUPERIORITY|||||||0.5055|||||||Fisher Exact|||||||0.5055
73860997|NCT02130986|147268012|SUPERIORITY||Mean Difference (Net)|-0.05||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
73860998|NCT02130986|147268013|NON_INFERIORITY|Procalcitonin algorithm implementation increases or does not change the proportion of subjects who experience a composite endpoint of adverse outcomes by Day 30. The prespecified noninferiority margin is 4.5 percentage.|Risk Difference (RD)|-0.015|||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73860999|NCT02130986|147268014|SUPERIORITY||Risk Difference (RD)|-4.6|||||TWO_SIDED|95.0|-12.2|30.0||||||||30|-12.2|
73917854|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.463|TWO_SIDED|90.0|-0.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-0.8|0.463
73917855|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.95||0.611|TWO_SIDED|90.0|-2.1|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-2.1|0.611
73917856|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.88||0.321|TWO_SIDED|90.0|-0.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.4|-0.6|0.321
73917857|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.85||0.294|TWO_SIDED|90.0|-0.5|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-0.5|0.294
73917858|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.99||0.987|TWO_SIDED|90.0|-1.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-1.7|0.987
73917859|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.04||0.599|TWO_SIDED|90.0|-1.2|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-1.2|0.599
73917860|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.322|TWO_SIDED|90.0|-0.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.6|-0.7|0.322
73917861|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.17||0.704|TWO_SIDED|90.0|-2.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-2.4|0.704
73917862|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.38||0.804|TWO_SIDED|90.0|-2.0|2.7|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.7|-2.0|0.804
73917863|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.38||0.559|TWO_SIDED|90.0|-3.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-3.2|0.559
73917864|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.27||0.369|TWO_SIDED|90.0|-1.0|3.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.4|-1.0|0.369
73917865|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.56||0.313|TWO_SIDED|90.0|-1.1|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.3|-1.1|0.313
73966759|NCT03526861|147470364|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|15.3|||<|0.001|TWO_SIDED|95.0|6.5|24.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||24.1|6.5|<0.001
73917866|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.56||0.56|TWO_SIDED|90.0|-1.8|3.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.6|-1.8|0.560
73917867|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.43||0.635|TWO_SIDED|90.0|-1.8|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.2|-1.8|0.635
73917868|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.62||0.538|TWO_SIDED|90.0|-1.8|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.8|-1.8|0.538
73917869|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.6||0.942|TWO_SIDED|90.0|-2.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.9|-2.7|0.942
73917870|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.5||0.555|TWO_SIDED|90.0|-1.7|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.5|-1.7|0.555
73917871|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.96||0.728|TWO_SIDED|90.0|-4.1|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.7|-4.1|0.728
73917872|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.95||0.362|TWO_SIDED|90.0|-5.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-5.2|0.362
73917873|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.81||0.538|TWO_SIDED|90.0|-2.0|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.3|-2.0|0.538
73917874|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.949|TWO_SIDED|90.0|-2.0|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.8|-2.0|0.949
73917875|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.09||0.708|TWO_SIDED|90.0|-2.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.5|-2.3|0.708
73917876|NCT02310568|147363777|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.07||0.752|TWO_SIDED|90.0|-1.5|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.2|-1.5|0.752
73917877|NCT02310568|147363778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|90.0|0.37|2.45|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||2.45|0.37|
73966760|NCT03526861|147470365|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-9.4|||<|0.001|TWO_SIDED|95.0|-13.5|-5.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-5.3|-13.5|<0.001
74027713|NCT01894516|147608738|SUPERIORITY||Difference in percentage rates|43.3|||<|0.0001|TWO_SIDED|95.0|28.4|58.2||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||58.2|28.4|< 0.0001
73917878|NCT02310568|147363778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||||TWO_SIDED|90.0|0.39|6.88|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||6.88|0.39|
73917879|NCT02310568|147363778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|90.0|0.23|1.49|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||1.49|0.23|
73966761|NCT03526861|147470365|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-9.4|||<|0.001|TWO_SIDED|95.0|-13.6|-5.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-5.3|-13.6|<0.001
73917880|NCT02989194|147363801|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.158||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 2. All null hypotheses were defined as no treatment difference.||||0.158
73917881|NCT02989194|147363801|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.025||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 3. All null hypotheses were defined as no treatment difference.||||0.025
73917882|NCT02989194|147363801|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.007||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 4. All null hypotheses were defined as no treatment difference.||||0.007
73917883|NCT02989194|147363801|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.061||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 5. All null hypotheses were defined as no treatment difference.||||0.061
73917884|NCT02989194|147363801|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.107||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 6. All null hypotheses were defined as no treatment difference.||||0.107
73917885|NCT02989194|147363801|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.237||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 7. All null hypotheses were defined as no treatment difference.||||0.237
73917886|NCT02989194|147363801|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.497||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 8. All null hypotheses were defined as no treatment difference.||||0.497
73917887|NCT02989194|147363801|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.704||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 9. All null hypotheses were defined as no treatment difference.||||0.704
73917888|NCT02989194|147363801|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.585||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 10. All null hypotheses were defined as no treatment difference.||||0.585
73917889|NCT02989194|147363812|SUPERIORITY|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.083|||||||t-test, 2 sided|||A t-test was used to assess the difference between the VIS410 total and placebo treatment groups from nasopharyngeal swabs based on the TCID50.||||0.083
73917890|NCT02989194|147363813|SUPERIORITY|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.169||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|t-test, 2 sided|||The null hypothesis was defined as no treatment difference.||||0.169
73917891|NCT02989194|147363814|SUPERIORITY|Descriptive Statistics. Statistical comparisons were performed using log rank test.||||||0.028||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|Log Rank|||Kaplan-Meier methods were used to calculate the median time. All null hypotheses were defined as no treatment difference.|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level, unless specifically stated otherwise. All null hypotheses were defined as no treatment difference. All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|||0.028
73917892|NCT02989194|147363816|EQUIVALENCE|Descriptive Statistics. All statistical comparisons were performed at the 0.05 significance level.||||||0.173||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|Log Rank|Kaplan-Meier methods were used to calculate the median time, 25th percentile and 75th percentile.||All null hypotheses were defined as no treatment difference.||||0.173
73917893|NCT04180488|147363825|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.23||||0.0005|TWO_SIDED|95.0|-6.63|-1.84||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-1.84|-6.63|0.0005
73966762|NCT03526861|147470366|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|11.5||||0.002|TWO_SIDED|95.0|4.5|18.4||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||18.4|4.5|0.002
74027714|NCT01981122|147608781|SUPERIORITY|||||||0.095|||||||Mixed Models Analysis|Repeated Measures||||||.095
73917894|NCT04180488|147363825|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.87||||0.0449|TWO_SIDED|95.0|-5.68|-0.07||Threshold for significance at 2-sided 0.043 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.07|-5.68|0.0449
73917895|NCT04180488|147363825|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.54||||0.0184|TWO_SIDED|95.0|-4.65|-0.43||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.43|-4.65|0.0184
73917896|NCT04180488|147363826|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-8.53||||0.0003|TWO_SIDED|95.0|-13.16|-3.9||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-3.90|-13.16|0.0003
73917897|NCT04180488|147363826|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.65||||0.0226|TWO_SIDED|95.0|-8.65|-0.65||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.65|-8.65|0.0226
73917898|NCT04180488|147363827|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.38||||0.0003|TWO_SIDED|95.0|-6.78|-1.98||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-1.98|-6.78|0.0003
73917899|NCT04180488|147363827|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.17||||0.0316|TWO_SIDED|95.0|-4.15|-0.19||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.19|-4.15|0.0316
73917900|NCT04180488|147363828|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|3.413||||0.0014|TWO_SIDED|95.0|1.596|7.299||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test was performed on association between responder status and intervention group, adjusted by baseline disease severity (UAS7\<28,\>=28), presence of angioedema at baseline and region.||7.299|1.596|0.0014
73917901|NCT04180488|147363828|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.507||||0.0109|TWO_SIDED|95.0|1.231|5.107||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||5.107|1.231|0.0109
73917902|NCT04180488|147363829|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.848||||0.0075|TWO_SIDED|95.0|1.301|6.234||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.234|1.301|0.0075
73917903|NCT04180488|147363829|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|3.137||||0.0045|TWO_SIDED|95.0|1.371|7.176||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||7.176|1.371|0.0045
73917904|NCT04180488|147363830|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.908||||0.0199|TWO_SIDED|95.0|1.173|7.209||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||7.209|1.173|0.0199
73917905|NCT04180488|147363830|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.677||||0.0187|TWO_SIDED|95.0|1.127|6.359||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.359|1.127|0.0187
73917906|NCT04180488|147363831|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|0.93||||0.194|TWO_SIDED|95.0|-0.48|2.34||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||2.34|-0.48|0.1940
73917907|NCT04180488|147363832|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.37||||0.0377|TWO_SIDED|95.0|-4.6|-0.13||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.13|-4.60|0.0377
73917908|NCT04180488|147363833|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-5.02||||0.0223|TWO_SIDED|95.0|-9.32|-0.72||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.72|-9.32|0.0223
73966763|NCT03526861|147470366|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|7.8|23.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||23.3|7.8|<0.001
73917909|NCT04180488|147363834|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.645||||0.0215|TWO_SIDED|95.0|1.154|6.061||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.061|1.154|0.0215
73917910|NCT04180488|147363835|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|1.872||||0.0971|TWO_SIDED|95.0|0.893|3.923||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||3.923|0.893|0.0971
73917911|NCT01635101|147363852|OTHER||LS Mean Difference|-11.8||||0.736|TWO_SIDED|97.5|-91.0|67.3|||ANOVA|||Difference in Least Squares (LS) Means||67.3|-91.0|0.736
73861000|NCT00762996|147268025|NON_INFERIORITY_OR_EQUIVALENCE|"margin +/- 0.5 logMar lines~The range of non-inferiority for this value is 0.50 thus +/- 0.50 is considered non-inferior to the 0.0 mark.~logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal."|Mean Difference (Final Values)|0.005287|STANDARD_ERROR_OF_MEAN|0.00976||||95.0|-0.01389|0.2447|||Mixed Models Analysis||logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.|Null Hypothesis: etafilcon A is greater than or equal to omafilcon A.||0.2447|-0.01389|
73861001|NCT00762996|147268026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4757|STANDARD_ERROR_OF_MEAN|0.2505||||95.0|0.05563|0.4757|||Mixed Models Analysis||Mean difference is etafilcon A minus omafilcon A.|||0.4757|0.05563|
73861002|NCT02084238|147268034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparing the data between baseline and week 10.||||<0.01
73861003|NCT01304329|147268039|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.05|STANDARD_DEVIATION|5.4|||TWO_SIDED|90.0|98.9|105.29|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|Considered characteristic is empa plus simvastatin divided by empa alone||105.29|98.90|
73861004|NCT01304329|147268040|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.26|STANDARD_DEVIATION|40.4|||TWO_SIDED|90.0|80.06|128.07|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin~Considered characteristic is empa plus simvastatin divided by simvastatin alone"||128.07|80.06|
73861005|NCT01304329|147268040|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|104.87|STANDARD_DEVIATION|25.5|||TWO_SIDED|90.0|90.09|122.07|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin acid~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||122.07|90.09|
73861006|NCT01304329|147268041|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|109.49|STANDARD_DEVIATION|21.1|||TWO_SIDED|90.0|96.91|123.69|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone||123.69|96.91|
73861007|NCT01304329|147268042|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.18|STANDARD_DEVIATION|41.7|||TWO_SIDED|90.0|76.3|123.77|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"Cmax of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||123.77|76.30|
73861008|NCT01304329|147268042|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.27|STANDARD_DEVIATION|22.7|||TWO_SIDED|90.0|84.9|111.44|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"Cmax of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||111.44|84.90|
73861009|NCT01304329|147268043|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.52|STANDARD_DEVIATION|5.8|||TWO_SIDED|90.0|99.1|106.06|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone.||106.06|99.10|
73861010|NCT01304329|147268044|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.34|STANDARD_DEVIATION|41.7|||TWO_SIDED|90.0|80.39|130.29|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||130.29|80.39|
73861011|NCT01304329|147268044|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|111.25|STANDARD_DEVIATION|24.8|||TWO_SIDED|90.0|95.93|129.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||129.02|95.93|
74027715|NCT01539837|147608818|SUPERIORITY||||||<|0.01||||||calculated|Pairwise comparisons,post-hoc Bonferoni|||||||<0.01
73861012|NCT02575118|147268052|OTHER||||||<|0.05|||||||linear mixed-effects regression models|All available data, and hence data for participants with missing observations at some time points, were included in the model.||In one saliva sample collected before treatment, the BPA concentration was more than 100 times higher (11.6 ng/ml) than the mean value and more than 100 SD from the mean of the remaining 19 samples. This saliva sample was excluded from the statistical analysis because it was probably contaminated. One participant had breakfast before the sample time point 1 wk after treatment, and thus the samples collected from this participant at this time point were not included in the statistical analysis.|We used mixed effects models and all available data (also data for participants with missing observations at some time points) were included in the model. Using mixed effects models is a recognized method when there are missing data. Thus, data from all 20 individuals were used for estimations at all time points (see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279).|||<0.05
73917912|NCT01635101|147363852|OTHER||LS Mean Difference|1.4||||0.967|TWO_SIDED|97.5|-75.9|78.7|||ANOVA|||LS Mean Difference||78.7|-75.9|0.967
74027716|NCT02988986|147608827|SUPERIORITY|Based on prior data for Ki67 changes in the tamoxifen arm alone, we will assume null hypothesis and alternative hypotheses of 60% and 80% reduction in Ki67, respectively. A sample of 25 patients will provide 86% power to detect the hypothesized reduction in Ki67 with 5% alpha based on a two-sided, one sample t-test of mean percent change in Ki67 level.|||||=|0.0023|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint was the change in Ki67 after 6 weeks of treatment.||||=0.0023
73861013|NCT02575118|147268053|OTHER||||||<|0.05|||||||linear mixed-effects regression models|All available data, and hence data for participants with missing observations at some time points, were included in the model.||One participant had breakfast before the sample time point 1 wk after treatment, and thus the samples collected from this participant at this time point were not included in the statistical analysis.|We used mixed effects models and all available data (also data for participants with missing observations at some time points), were included in the model. Using mixed effects models is a recognized method when there are missing data. Thus, data from all 20 individuals were used for estimations at all time points (see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279).|||<0.05
73861014|NCT01735708|147268066|SUPERIORITY|ITT analysis using multiple imputation by chained equation with 50 fully populated data sets.|Mean Difference (Net)|-1.31|STANDARD_ERROR_OF_MEAN|0.493||0.008|TWO_SIDED|95.0|-2.28|-0.34||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|standard error of difference in means|||-0.34|-2.28|0.008
73861015|NCT01735708|147268067|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.495||0.251|TWO_SIDED|95.0|-1.53|0.4||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.||||0.40|-1.53|0.251
73861016|NCT01735708|147268068|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.75||0.844|TWO_SIDED|95.0|-1.32|1.61||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|Standard error of difference in means.|||1.61|-1.32|0.844
73861017|NCT01735708|147268069|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.836||0.545|TWO_SIDED|95.0|-2.18|1.15||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|Standard error of difference in means.|||1.15|-2.18|0.545
73861018|NCT04883528|147268070|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
73861019|NCT04883528|147268071|SUPERIORITY|||||||0.88|||||||Mixed Models Analysis|||||||0.88
73861020|NCT04883528|147268072|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
73861021|NCT04883528|147268073|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.85
73861022|NCT04883528|147268074|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||||||0.80
73861023|NCT04883528|147268075|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
73861024|NCT04883528|147268076|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||0.23
73861025|NCT04883528|147268077|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|||||||0.95
73861026|NCT04883528|147268078|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
73861027|NCT04883528|147268082|SUPERIORITY||Least squares mean difference|-0.01||||0.64|TWO_SIDED|95.0|-0.07|0.04|||Mixed Models Analysis|||||0.04|-0.07|0.64
73861028|NCT04883528|147268083|SUPERIORITY||Least squares mean difference|-7.55||||0.04|TWO_SIDED|95.0|-14.59|0.52|||Mixed Models Analysis|||||0.52|-14.59|0.04
73861029|NCT00844805|147268102|SUPERIORITY_OR_OTHER||Difference in Percentages|14.9|||=|0.0884|TWO_SIDED|95.0|-1.7|31.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||31.5|-1.7|=0.0884
73861030|NCT00844805|147268103|SUPERIORITY_OR_OTHER||Difference in Percentages|21.7|||=|0.0013|TWO_SIDED|95.0|11.0|32.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||32.5|11.0|=0.0013
73861031|NCT00844805|147268104|SUPERIORITY_OR_OTHER||Difference in Percentages|18.1|||=|0.0004|TWO_SIDED|95.0|10.7|25.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||25.5|10.7|=0.0004
73861032|NCT00844805|147268105|SUPERIORITY_OR_OTHER||Difference in Percentages|10.0|||=|0.5005|TWO_SIDED|95.0|-11.7|31.7|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||31.7|-11.7|=0.5005
73861033|NCT00844805|147268106|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.5|||=|1|TWO_SIDED|95.0|-14.9|9.9|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||9.9|-14.9|=1.0000
73861034|NCT00844805|147268107|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||=|1|TWO_SIDED|95.0|-6.8|6.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||6.8|-6.8|=1.0000
73861035|NCT00844805|147268108|SUPERIORITY_OR_OTHER||||||=|0.3802||95.0|||||Log Rank|||||||=0.3802
73861036|NCT00844805|147268109|SUPERIORITY_OR_OTHER||Difference in Percentages|-5.0|||=|0.6153|TWO_SIDED|95.0|-14.5|4.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||4.5|-14.5|=0.6153
73861037|NCT00844805|147268110|SUPERIORITY_OR_OTHER||Difference in Percentages|18.4|||=|0.0263|TWO_SIDED|95.0|2.5|34.3|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||34.3|2.5|=0.0263
73861038|NCT00844805|147268111|SUPERIORITY_OR_OTHER||Difference in Percentages|8.4|||=|0.3011|TWO_SIDED|95.0|-6.0|22.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||22.8|-6.0|=0.3011
73861039|NCT00131456|147268174|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Regression, Logistic|||Logistic regression was used to analyze all dichotomous outcomes. The dichotomous primary outcome marijuana abstinence was modeled using independent predictors: treatment(Venlafaxine vs. Placebo) and baseline urine THC level. The initial analysis included an interaction between treatment and baseline urine THC levels which was deemed not significant and omitted from the final logistic model.||||<0.01
73861040|NCT00262847|147268175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.954||||0.448||95.0|0.844|1.078|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.078|0.844|0.448
73861041|NCT00262847|147268175|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.765|||<|0.001||95.0|0.676|0.866|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||0.866|0.676|<0.001
73861042|NCT00262847|147268176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.069||||0.41||95.0|0.912|1.255|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.255|0.912|0.410
73917913|NCT01327885|147363862|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.768|||=|0.0169|TWO_SIDED|95.0|0.618|0.954||The P-value was calculated by 2-sided log-rank test as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|Statistical analysis was designed to detect superiority of Arm A (eribulin) over Arm B (dacarbazine). OS was compared between the two treatment arms using a two-sided stratified log-rank test at a nominal significance level of 0.0455 (adjusted for the interim analysis). This was the primary analysis that was performed when the target number of events (\~353 deaths) was observed.||0.954|0.618|=0.0169
73917914|NCT01327885|147363863|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.877|||=|0.2287|TWO_SIDED|95.0|0.71|1.085||P-value was calculated by 2-sided log-rank test, as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|The PFS and PFS rate at 3, 6, and 12 months (95% confidence interval (CI)) was calculated using Kaplan-Meier (K-M) product-limit method and Greenwood Formula. PFS was compared between the treatment arms using two-sided stratified log-rank test, stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.085|0.710|=0.2287
73917915|NCT01327885|147363864|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3||||0.253|TWO_SIDED|95.0|0.8|1.9||The P-value was calculated using the stratified CMH method, the stratified factors included histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The odds ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of the odds ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.9|0.8|0.253
73917916|NCT01327885|147363865|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9|||=|0.741|TWO_SIDED|95.0|0.7|1.4||The P-value was calculated using the CMH method. The stratified factors were histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The Odds Ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of Odds Ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified CMH chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.4|0.7|=0.741
73917917|NCT03232801|147363866|SUPERIORITY||chi-squared|4.86||||0.027|TWO_SIDED||||||Chi-squared|||||||0.027
73917918|NCT03232801|147363867|SUPERIORITY||chi-squared|0.45||||0.503|TWO_SIDED||||||Chi-squared|||||||0.503
73917919|NCT03395886|147363918|OTHER|||||||0.831|||||||Chi-squared|||Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test.||||0.831
73917920|NCT03395886|147363919|OTHER|||||||0.8|||||||Generalized estimating equations|||||||0.800
73917921|NCT05620563|147363937|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.28|0.87|||||Posterior mean difference with 95% credible interval is reported.|||0.87|-0.28|
73917922|NCT05620563|147363938|SUPERIORITY||Posterior Mean Difference|-0.15|||||TWO_SIDED|95.0|-1.13|0.82|||||Posterior mean difference with 95% credible interval is reported.|||0.82|-1.13|
73917923|NCT05620563|147363939|SUPERIORITY||Posterior Mean Difference|-0.47|||||TWO_SIDED|95.0|-0.99|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.99|
73917924|NCT05620563|147363940|SUPERIORITY||Posterior Mean Difference|-0.55|||||TWO_SIDED|95.0|-3.82|2.69|||||Posterior mean difference with 95% credible interval is reported.|||2.69|-3.82|
73917925|NCT05620563|147363941|SUPERIORITY||Posterior Mean Difference|0.09|||||TWO_SIDED|95.0|-0.33|0.51|||||Posterior mean difference with 95% credible interval is reported.|||0.51|-0.33|
74027717|NCT01334125|147608837|SUPERIORITY_OR_OTHER|||||||0.903|TWO_SIDED|||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).||||0.903
73917926|NCT05620563|147363942|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.35|0.95|||||Posterior mean difference with 95% credible interval is reported.|||0.95|-0.35|
73917927|NCT05620563|147363943|SUPERIORITY||Posterior Mean Difference|2.2|||||TWO_SIDED|95.0|-5.7|9.99|||||Posterior mean difference with 95% credible interval is reported.|||9.99|-5.70|
73917928|NCT05620563|147363944|SUPERIORITY||Posterior Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.39|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.39|
73917929|NCT05620563|147363945|SUPERIORITY||Posterior Mean Difference|24.16|||||TWO_SIDED|95.0|-115.48|166.06|||||Posterior mean difference with 95% credible interval is reported.|||166.06|-115.48|
73917930|NCT05620563|147363946|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.09|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.09|
73917931|NCT01170754|147363948|NON_INFERIORITY|Inferiority between the two groups was defined as a difference of 10% in the overall BBPS score||||||0.45|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.45
73917932|NCT01170754|147363949|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.13|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.13
73917933|NCT01170754|147363950|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.31|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.31
73917934|NCT01170754|147363951|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.87|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.87
73917935|NCT01170754|147363952|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.25|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.25
73917936|NCT01170754|147363953|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.47|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.47
73861043|NCT00262847|147268176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.131||95.0|0.746|1.039|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.039|0.746|0.131
74086473|NCT00292227|147726489|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.65||||||90.0|-0.65|3.96|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.96|-0.65|
74088416|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.5339|STANDARD_ERROR_OF_MEAN|0.2803||0.0607||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of sexual identity(Straight (heterosexual) vs. Gay (homosexual), Bi (bisexual), and Not Sure or Undecided) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0607
73861044|NCT03880838|147268187|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.391|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.391
73861045|NCT03880838|147268187|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.861|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.861
73861046|NCT03880838|147268187|SUPERIORITY||Slope|-0.02|STANDARD_DEVIATION|0.01||0.835|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.835
73861047|NCT03880838|147268187|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.877|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.877
73861048|NCT03880838|147268187|SUPERIORITY||Slope|0.004|STANDARD_ERROR_OF_MEAN|0.01||0.969|TWO_SIDED||||||Regression, Logistic|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.969
73861049|NCT03880838|147268187|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.893|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.893
73861050|NCT03880838|147268187|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.689|TWO_SIDED||||||Regression, Linear|||In this contrast, In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.689
73861051|NCT03880838|147268187|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.427|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.427
73861052|NCT03880838|147268187|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.504|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.504
73861053|NCT03880838|147268187|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.893|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.893
73917937|NCT01170754|147363954|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.34|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.34
73917938|NCT01170754|147363955|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.18|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.18
73917939|NCT01170754|147363956|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.75|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.75
73917940|NCT01170754|147363957|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.92|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.92
73917941|NCT01170754|147363958|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.6|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.60
73917942|NCT01170754|147363959|NON_INFERIORITY|Inferiority between groups was defined as a difference of 10% in the overall BBPS score.||||||0.98|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance.|t-test, 2 sided|||||||.98
73917943|NCT02692703|147363973|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment as compared with the historical rate for the current standard of care regimens (SOF/LDV + RBV or SOF + DCV + RBV) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 86% to achieve noninferiority.|Percentage of Participants|98.0|||||TWO_SIDED|95.0|95.3|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96%, 90 participants provides \>90% power to demonstrate noninferiority of the regimen to the historical rate for current standard of care regimens (SOF/LDV + RBV OR SOF + DCV + RBV) (94%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|95.3|
73917944|NCT03765918|147364032|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|9.3|||<|1e-05|TWO_SIDED|95.0|6.7|12.8||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||12.8|6.7|<0.00001
74027718|NCT01334125|147608838|SUPERIORITY_OR_OTHER|||||||0.578|TWO_SIDED|95.0||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).||||0.578
74027719|NCT01334125|147608839|SUPERIORITY_OR_OTHER|||||||0.057|||||||ANOVA|||Two way ANOVA comparison of the means of the adiponectin/leptin ratios between the metformin and placebo groups||||0.057
74027720|NCT01334125|147608840|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||p value represents the analysis for minor hypoglycemia||||1.00
74027721|NCT01334125|147608840|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||p value represents the analysis of the nocturnal hypoglycemia||||1.00
74027722|NCT00401973|147608842|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|Mixed Models Analysis|Repeated Measures Analysis||To detect a difference between treatment arms of 3.06 kg in mean weight change from baseline to endpoint, 150 patients must be enrolled in stepped intervention arm and 50 in control arm. Assuming a standard deviation of 6.87 kg, there is 80% power to detect a difference between treatment arms on a 1-sided 2-sample t-test at the 5% significance level. Primary analysis was the comparison of mean weight change for 'olanzapine only' versus pooled 'olanzapine \& adjunctive treatment' arm at Week 22.||||0.065
74027723|NCT00401973|147608842|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Mixed Models Analysis|Repeated Measures Analysis||Hypothesis=weight gain associated with olanzapine can be prevented or mitigated with an adjunctive pharmacological algorithm.||||0.113
74086474|NCT00292227|147726490|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.21||||||90.0|-1.78|1.36|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.36|-1.78|
74086475|NCT00292227|147726491|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.53||||||90.0|-2.37|1.3|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.30|-2.37|
74027724|NCT00401973|147608842|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Mixed Models Analysis|Repeated Measures Analysis||||||0.036
74027725|NCT00401973|147608843|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.498
73861054|NCT03880838|147268187|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.918|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.918
73861055|NCT03880838|147268187|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.755|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.755
73861056|NCT03880838|147268187|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.858|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.858
73861057|NCT03880838|147268188|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.46||0.436|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.436
74027726|NCT00401973|147608843|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.637
73861058|NCT03880838|147268188|SUPERIORITY||Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.45||0.539|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.539
74027727|NCT00401973|147608843|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.125
74027728|NCT00401973|147608844|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.173
74027729|NCT00401973|147608844|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.016
74027730|NCT00401973|147608844|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.029
74027731|NCT00401973|147608845|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.017
74027732|NCT00401973|147608845|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.015
74027733|NCT00401973|147608845|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.071
74027734|NCT00401973|147608846|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.152
74027735|NCT00401973|147608846|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.350
74027736|NCT00401973|147608846|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.123
73917945|NCT03765918|147364033|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|13.7|||<|1e-05|TWO_SIDED|95.0|9.7|18.7||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||18.7|9.7|<0.00001
73917946|NCT03765918|147364034|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|9.8|||<|1e-05|TWO_SIDED|95.0|7.0|13.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||13.3|7.0|<0.00001
73917947|NCT03765918|147364035|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|3.0||||0.0006|TWO_SIDED|95.0|1.5|5.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||5.3|1.5|0.0006
73917948|NCT03765918|147364036|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|4.2||||0.0011|TWO_SIDED|95.0|2.1|7.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||7.6|2.1|0.0011
73917949|NCT03765918|147364037|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|3.1||||0.0006|TWO_SIDED|95.0|1.6|5.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||5.6|1.6|0.0006
73917950|NCT03765918|147364044|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.29||||0.4671|TWO_SIDED|95.0|-4.78|2.2||Two-sided p-value based on cLDA model.|cLDA model|||||2.20|-4.78|0.4671
73917951|NCT03765918|147364045|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.03||||0.1606|TWO_SIDED|95.0|-7.27|1.21||Two-sided p-value based on cLDA model.|cLDA model|||||1.21|-7.27|0.1606
73917952|NCT03765918|147364046|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.41||||0.4374|TWO_SIDED|95.0|-4.96|2.15||Two-sided p-value based on cLDA model.|cLDA model|||||2.15|-4.96|0.4374
73917953|NCT03765918|147364047|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.39||||0.8379|TWO_SIDED|95.0|-3.35|4.13||Two-sided p-value based on cLDA model.|cLDA model|||||4.13|-3.35|0.8379
73917954|NCT03765918|147364048|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.39||||0.8643|TWO_SIDED|95.0|-4.84|4.07||Two-sided p-value based on cLDA model.|cLDA model|||||4.07|-4.84|0.8643
73917955|NCT03765918|147364049|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.29||||0.8813|TWO_SIDED|95.0|-4.12|3.54||Two-sided p-value based on cLDA model.|cLDA model|||||3.54|-4.12|0.8813
73917956|NCT03765918|147364056|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.34||||0.8287|TWO_SIDED|95.0|-2.76|3.45||Two-sided p-value based on cLDA model.|cLDA model|||||3.45|-2.76|0.8287
73917957|NCT03765918|147364057|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.53||||0.7761|TWO_SIDED|95.0|-3.12|4.18||Two-sided p-value based on cLDA model.|cLDA model|||||4.18|-3.12|0.7761
74088417|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3883|STANDARD_ERROR_OF_MEAN|0.2779||0.167||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which the subject first had unforced sex (Never vs. \<= 14 year olds vs. 15-17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. \<= 14 year olds is presented."||||0.1670
73917958|NCT03765918|147364058|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.65||||0.688|TWO_SIDED|95.0|-2.54|3.84||Two-sided p-value based on cLDA model.|cLDA model|||||3.84|-2.54|0.6880
73917959|NCT03765918|147364059|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.45||||0.3858|TWO_SIDED|95.0|-4.73|1.83||Two-sided p-value based on cLDA model.|cLDA model|||||1.83|-4.73|0.3858
73917960|NCT03765918|147364060|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.45||||0.237|TWO_SIDED|95.0|-6.53|1.62||Two-sided p-value based on cLDA model.|cLDA model|||||1.62|-6.53|0.2370
73917961|NCT03765918|147364061|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.76||||0.3138|TWO_SIDED|95.0|-5.2|1.67||Two-sided p-value based on cLDA model.|cLDA model|||||1.67|-5.20|0.3138
73917962|NCT03765918|147364068|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.28||||0.1763|TWO_SIDED|95.0|-8.05|1.48||Two-sided p-value based on cLDA model.|cLDA model|||||1.48|-8.05|0.1763
73917963|NCT03765918|147364069|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.18||||0.6882|TWO_SIDED|95.0|-6.95|4.59||Two-sided p-value based on cLDA model.|cLDA model|||||4.59|-6.95|0.6882
73917964|NCT03765918|147364070|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.52||||0.3103|TWO_SIDED|95.0|-7.39|2.35||Two-sided p-value based on cLDA model.|cLDA model|||||2.35|-7.39|0.3103
73917965|NCT03765918|147364071|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.48||||0.8475|TWO_SIDED|95.0|-5.41|4.45||Two-sided p-value based on cLDA model.|cLDA model|||||4.45|-5.41|0.8475
73917966|NCT03765918|147364072|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.42||||0.8881|TWO_SIDED|95.0|-6.36|5.51||Two-sided p-value based on cLDA model.|cLDA model|||||5.51|-6.36|0.8881
73917967|NCT03765918|147364073|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.22||||0.9307|TWO_SIDED|95.0|-5.22|4.78||Two-sided p-value based on cLDA model.|cLDA model|||||4.78|-5.22|0.9307
73917968|NCT03765918|147364080|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|1.3||||0.5752|TWO_SIDED|95.0|-3.25|5.85||Two-sided p-value based on cLDA model.|cLDA model|||||5.85|-3.25|0.5752
74086476|NCT00292227|147726492|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.41||||||90.0|-2.3|1.49|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.49|-2.30|
74086477|NCT00292227|147726493|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.5||||||90.0|-2.34|1.35|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.35|-2.34|
74086478|NCT00292227|147726494|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.21||||||90.0|-1.76|2.17|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.17|-1.76|
74086479|NCT00292227|147726495|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.23||||||90.0|-2.99|0.53|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.53|-2.99|
73917969|NCT03765918|147364081|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.98||||0.7196|TWO_SIDED|95.0|-4.38|6.34||Two-sided p-value based on cLDA model.|cLDA model|||||6.34|-4.38|0.7196
73917970|NCT03765918|147364082|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.74||||0.7522|TWO_SIDED|95.0|-3.88|5.37||Two-sided p-value based on cLDA model.|cLDA model|||||5.37|-3.88|0.7522
74088418|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|0.0344|STANDARD_ERROR_OF_MEAN|0.2065||0.8682||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which subject had first unforced sex (Never vs. \<= 14 year olds vs. 15 - 17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. 15-17 year olds is presented."||||0.8682
73917971|NCT03765918|147364083|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.24||||0.9255|TWO_SIDED|95.0|-5.3|4.82||Two-sided p-value based on cLDA model.|cLDA model|||||4.82|-5.30|0.9255
73917972|NCT03765918|147364084|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|2.22||||0.4926|TWO_SIDED|95.0|-4.15|8.6||Two-sided p-value based on cLDA model.|cLDA model|||||8.60|-4.15|0.4926
73917973|NCT03765918|147364085|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.99||||0.7087|TWO_SIDED|95.0|-4.23|6.21||Two-sided p-value based on cLDA model.|cLDA model|||||6.21|-4.23|0.7087
73917974|NCT03765918|147364092|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.75||||0.1654|TWO_SIDED|95.0|-6.65|1.14||Two-sided p-value based on cLDA model.|cLDA model|||||1.14|-6.65|0.1654
73917975|NCT03765918|147364093|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.26||||0.9117|TWO_SIDED|95.0|-4.29|4.8||Two-sided p-value based on cLDA model.|cLDA model|||||4.80|-4.29|0.9117
73917976|NCT03765918|147364094|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.22||||0.2808|TWO_SIDED|95.0|-6.25|1.82||Two-sided p-value based on cLDA model.|cLDA model|||||1.82|-6.25|0.2808
73917977|NCT03765918|147364095|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.77||||0.1577|TWO_SIDED|95.0|-6.62|1.08||Two-sided p-value based on cLDA model.|cLDA model|||||1.08|-6.62|0.1577
73917978|NCT03765918|147364096|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.81||||0.2485|TWO_SIDED|95.0|-7.59|1.97||Two-sided p-value based on cLDA model.|cLDA model|||||1.97|-7.59|0.2485
73917979|NCT03765918|147364097|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.03||||0.1364|TWO_SIDED|95.0|-7.03|0.96||Two-sided p-value based on cLDA model.|cLDA model|||||0.96|-7.03|0.1364
73917980|NCT03765918|147364103|SUPERIORITY|Hazard ratio (HR) and associated 95% confidence interval (CI) were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.73||||0.00411|TWO_SIDED|95.0|0.58|0.92|||Stratified Log Rank|One-sided p-value was based on log-rank test stratified by primary tumor site and tumor stage.||||0.92|0.58|0.00411
73917981|NCT03765918|147364104|SUPERIORITY|HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.66||||0.00217|TWO_SIDED|95.0|0.49|0.88|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.||||0.88|0.49|0.00217
73917982|NCT03765918|147364105|SUPERIORITY|HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.7||||0.0014|TWO_SIDED|95.0|0.55|0.89|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.||||0.89|0.55|0.00140
74086480|NCT00292227|147726496|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.62||||||90.0|-3.87|0.63|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.63|-3.87|
73917983|NCT02602496|147364168|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9942||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9942
73917984|NCT02602496|147364168|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0062|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0062
73917985|NCT02602496|147364168|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.6843|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.6843
73917986|NCT02602496|147364169|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.5096||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.5096
73917987|NCT02602496|147364169|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.2276|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.2276
73917988|NCT02602496|147364169|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0006|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0006
73917989|NCT02602496|147364170|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9708||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9708
73917990|NCT02602496|147364170|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.1642|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.1642
73917991|NCT02602496|147364170|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.6043|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.6043
73917992|NCT02602496|147364171|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0868||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.0868
73917993|NCT02602496|147364171|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0083|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0083
73917994|NCT02602496|147364171|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0151|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0151
73917995|NCT02602496|147364172|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9255||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9255
73917996|NCT02602496|147364172|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0454|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0454
73917997|NCT02602496|147364172|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.292|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.2920
73917998|NCT02602496|147364173|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.2252||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.2252
73917999|NCT02602496|147364173|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.4715|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.4715
73918000|NCT02602496|147364173|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.7157|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.7157
73966764|NCT03526861|147470367|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|26.2|||<|0.001|TWO_SIDED|95.0|16.1|36.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||36.3|16.1|<0.001
73918001|NCT02602496|147364174|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.8323||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.8323
73971397|NCT03974178|147483460|OTHER|"The minimal sample size to get a possible rejection of H0 (pdeath = 8.5% or more) in favour of H1 (pdeath \<8.5%) was 34 evaluable patients with stage 2 r-HAT.~The hypothesis was tested with a one-sided exact test for proportions at the 0.05 significance level."|Fatality rate|0.0||||0.0488|TWO_SIDED|90.0|0.0|8.43||The rate of deaths possibly related to r-HAT or to fexinidazole at the end of hospitalization was compared to the predefined unacceptable rate of 8.5%.|one-sided exact test|Clopper Pearson exact method||"The proportion of deaths (pdeath) is compared to the threshold of 8.5%, with H0 being pdeath = 8.5% or more.~The 90% confidence interval of the fatality rate is calculated with the Clopper-Pearson method."||8.43|0|0.0488
74027737|NCT00401973|147608847|SUPERIORITY_OR_OTHER|||||||0.499||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.499
73918002|NCT02602496|147364174|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.8927|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.8927
73918003|NCT02602496|147364174|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.3173|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.3173
73918004|NCT02602496|147364175|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.27||||||Corrected for baseline concentrations, age and gender|ANOVA|||||||0.27
73918005|NCT05025241|147364179|OTHER||||||<|0.0001|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||<0.0001
73918006|NCT05025241|147364180|OTHER|||||||0.0003|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0003
73918007|NCT05025241|147364181|OTHER|Change from baseline||||||0.0156|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0156
73918008|NCT05025241|147364182|OTHER|Change from baseline||||||0.0005|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0005
73918009|NCT05025241|147364183|OTHER|||||||0.0647|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants.||||0.0647
74027738|NCT00401973|147608847|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.833
74027739|NCT00401973|147608847|SUPERIORITY_OR_OTHER|||||||0.339||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.339
73918010|NCT05025241|147364184|OTHER|Change from baseline||||||0.0984|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0984
73918011|NCT05025241|147364185|OTHER|Change from baseline||||||0.0013|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0013
73918012|NCT05025241|147364186|OTHER|Change from baseline||||||0.0191|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0191
73918013|NCT05025241|147364187|OTHER|change from baseline||||||0.0013|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0013
73918014|NCT05025241|147364188|OTHER|change from baseline||||||0.171|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.1710
73918015|NCT05025241|147364189|OTHER|change from baseline||||||0.0066|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0066
73918016|NCT05025241|147364190|OTHER|change form baseline||||||0.1094|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.1094
73918017|NCT05025241|147364191|OTHER|change from baseline||||||0.0156|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0156
73918018|NCT05025241|147364192|OTHER|change from baseline||||||0.0326|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0326
73918019|NCT02850965|147364249|EQUIVALENCE|Protocol defined margins are: \[-18.0%, +18.0%\] for Week 16, 95% confidence interval. Between-imputation variance is zero. Confidence interval is based on one imputed set.|Difference in PASI 75 Response Rate|-2.2|||||TWO_SIDED|95.0|-14.4|8.7|||Regression, Logistic||Difference in PASI 75 Response Rate = (BI 695501 - US-licensed Humira, %).|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.|8.7|-14.4|
73918020|NCT02850965|147364250|OTHER|Missing PASI 75 at Week 24 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in PASI 75 Response Rate|2.9|||||TWO_SIDED|95.0|-8.5|12.6|||Regression, Logistic||Difference in PASI 75 Response Rate = (BI 695501 - US-licensed Humira, %).|The week 24 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 24)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.|12.6|-8.5|
73861059|NCT03880838|147268188|SUPERIORITY||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.66||0.994|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.994
73861060|NCT03880838|147268188|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.66||0.7|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.700
73861061|NCT03880838|147268188|SUPERIORITY||Slope|0.75|STANDARD_ERROR_OF_MEAN|0.66||0.258|TWO_SIDED||||||Regression, Logistic|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.258
73861062|NCT03880838|147268188|SUPERIORITY||Slope|-0.49|STANDARD_ERROR_OF_MEAN|0.62||0.428|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.428
73861063|NCT03880838|147268188|SUPERIORITY||Slope|-0.48|STANDARD_ERROR_OF_MEAN|0.62||0.434|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.434
73861064|NCT03880838|147268188|SUPERIORITY||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.62||0.228|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.228
73861065|NCT03880838|147268188|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.674|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.674
73861066|NCT03880838|147268188|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.61||0.799|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.799
73861067|NCT03880838|147268188|SUPERIORITY||Slope|0.16|STANDARD_ERROR_OF_MEAN|0.61||0.794|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.794
73861068|NCT03880838|147268188|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.871|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.871
73861069|NCT03880838|147268188|SUPERIORITY||Slope|0.9|STANDARD_ERROR_OF_MEAN|0.62||0.139|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.139
73861070|NCT03880838|147268189|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.29||0.357|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.357
73861071|NCT03880838|147268189|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.28||0.294|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.294
73861072|NCT03880838|147268189|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|0.4||0.496|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.496
73861073|NCT03880838|147268189|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.4||0.722|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.722
73861074|NCT03880838|147268189|SUPERIORITY||Slope|0.31|STANDARD_ERROR_OF_MEAN|0.4||0.445|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.445
73861075|NCT03880838|147268189|SUPERIORITY||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.38||0.531|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.531
73861076|NCT03880838|147268189|SUPERIORITY||Slope|-0.51|STANDARD_ERROR_OF_MEAN|0.38||0.177|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.177
73861077|NCT03880838|147268189|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.38||0.314|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.314
73861078|NCT03880838|147268189|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.38||0.85|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.850
73861079|NCT03880838|147268189|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.37||0.391|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.391
73861080|NCT03880838|147268189|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.37||0.906|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.906
73861081|NCT03880838|147268189|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.37||0.635|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.635
73861082|NCT03880838|147268189|SUPERIORITY||Slope|0.63|STANDARD_ERROR_OF_MEAN|0.37||0.093|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||0.093
73861083|NCT03710876|147268219|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.284|TWO_SIDED|95.0|0.43|1.59||1-sided|Log Rank|||||1.59|0.43|0.2840
73861084|NCT03710876|147268221|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-17.3|24.3||2-sided|Fisher Exact||Risk difference is proportion achieving objective response in r+C+G group minus the proportion achieving objective response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||24.3|-17.3|1.0000
73918021|NCT02850965|147364251|OTHER||Difference of Least Squares Means|1.7|||||TWO_SIDED|95.0|-2.7|6.0|||ANCOVA|Analysis of covariance (ANCOVA)|Difference of Least Squares Means (LSM)= LSM of (BI 695501 - Humira)|Analysis of covariance (ANCOVA) was performed based on the following model: PASI percentage improvement from baseline at Week 16= Treatment + Baseline PASI +Prior exposure to a biologic agent + random error.||6.0|-2.7|
73918022|NCT02850965|147364252|OTHER|Missing sPGA at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in sPGA <= 1 Response Rate|7.5|||||TWO_SIDED|95.0|-4.8|19.1|||Regression, Logistic||Difference in sPGA \<= 1 Response Rate = (BI 695501 - US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.|19.1|-4.8|
73918023|NCT02850965|147364253|OTHER|Missing DLQI at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in DLQI Response Rate|0.4|||||TWO_SIDED|95.0|-11.7|11.3|||Regression, Logistic||Difference in DLQI (0, 1) Response Rate = (BI 695501 - US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.|11.3|-11.7|
73918024|NCT00923247|147364270|SUPERIORITY_OR_OTHER|||||||0.019|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1, day 1 vs. cycle 3, day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib Cmax (normalized to dose).||||0.019
73966765|NCT03526861|147470367|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|25.5|||<|0.001|TWO_SIDED|95.0|15.3|35.7||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||35.7|15.3|<0.001
73966766|NCT03526861|147470368|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-1.5|||<|0.001|TWO_SIDED|95.0|-2.4|-0.6||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.6|-2.4|<0.001
73966767|NCT03526861|147470368|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-1.2||||0.007|TWO_SIDED|95.0|-2.1|-0.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.3|-2.1|0.007
74027740|NCT00401973|147608848|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.278
74027741|NCT00401973|147608848|SUPERIORITY_OR_OTHER|||||||0.976||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.976
73918025|NCT00923247|147364271|SUPERIORITY_OR_OTHER|||||||0.052|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib AUCinf (normalized to dose).||||0.052
73918026|NCT00923247|147364272|SUPERIORITY_OR_OTHER|||||||0.44|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib half-life.||||0.440
73918027|NCT00923247|147364273|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib clearance.||||0.016
73918028|NCT00923247|147364274|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase I portion. To assess whether presence of vandetanib significantly altered bortezomib volume of distribution.||||0.010
73918029|NCT03791489|147364282|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74027742|NCT00401973|147608848|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.049
74027743|NCT00401973|147608849|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.122
74027744|NCT00401973|147608849|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.225
74027745|NCT00401973|147608849|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.124
74027746|NCT00401973|147608850|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.020
74027747|NCT00401973|147608850|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Change from Baseline|ANCOVA|||||||0.037
74027748|NCT00401973|147608850|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.038
73918030|NCT03791489|147364283|SUPERIORITY||||||<|0.03||||||Threshold for statistical significance = p\<0.05.|t-test, 2 sided|||||||<0.03
73918031|NCT00646776|147364318|SUPERIORITY_OR_OTHER||Point Estimate|1.477|||||TWO_SIDED|90.0|1.188|1.835|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||1.835|1.188|
73918032|NCT00646776|147364319|SUPERIORITY_OR_OTHER||Point Estimate|2.489|||||TWO_SIDED|90.0|2.025|3.06|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||3.060|2.025|
73918033|NCT00646776|147364320|SUPERIORITY_OR_OTHER||Point Estimate|1.402|||||TWO_SIDED|90.0|1.052|1.867|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||1.867|1.052|
73918034|NCT00646776|147364321|SUPERIORITY_OR_OTHER||Point Estimate|0.947|||||TWO_SIDED|90.0|0.817|1.098|||ANOVA|||||1.098|0.817|
73918035|NCT00646776|147364322|SUPERIORITY_OR_OTHER||Point Estimate|0.745||||0.0963|TWO_SIDED|90.0|0.5569|0.9967|||ANOVA|||||0.9967|0.5569|0.0963
73918036|NCT00646776|147364323|SUPERIORITY_OR_OTHER||Point Estimate|0.857|||||TWO_SIDED|90.0|0.723|1.015|||ANOVA|||||1.015|0.723|
74086481|NCT00292227|147726497|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.81||||||90.0|-2.55|0.93|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.93|-2.55|
73918037|NCT00646776|147364326|SUPERIORITY_OR_OTHER||Point Estimate|0.66|||||TWO_SIDED|90.0|0.538|0.809|||ANOVA|||||0.809|0.538|
73918038|NCT00646776|147364327|SUPERIORITY_OR_OTHER||Point Estimate|0.651|||||TWO_SIDED|90.0|0.43|0.986|||ANOVA|||||0.986|0.430|
73918039|NCT00646776|147364328|SUPERIORITY_OR_OTHER||Point Estimate|0.696|||||TWO_SIDED|90.0|0.563|0.862|||ANOVA|||||0.862|0.563|
73918040|NCT00646776|147364334|SUPERIORITY_OR_OTHER||Point Estimate|10.902|||||TWO_SIDED|90.0|8.135|14.61|||ANOVA|||||14.610|8.135|
73918041|NCT00646776|147364335|SUPERIORITY_OR_OTHER||Point Estimate|7.766|||||TWO_SIDED|90.0|6.133|9.833|||ANCOVA|||||9.833|6.133|
73918042|NCT00646776|147364336|SUPERIORITY_OR_OTHER||Point Estimate|11.451|||||TWO_SIDED|90.0|8.147|16.095|||ANOVA|||||16.095|8.147|
73918043|NCT00646776|147364337|SUPERIORITY_OR_OTHER||Point Estimate|2.19|||||TWO_SIDED|90.0|1.783|2.691|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||2.691|1.783|
73918044|NCT01753856|147364354|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
73918045|NCT01753856|147364355|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and SL, in CC.|Fisher Exact|||||||<0.001
73918046|NCT01753856|147364355|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||SL Only, in CC.|Fisher Exact|||||||0.002
73918047|NCT01753856|147364355|SUPERIORITY_OR_OTHER|||||||0.494|TWO_SIDED|||||No Label, in CC.|Fisher Exact|||||||0.494
73918048|NCT01753856|147364355|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||DL and SL, in EC.|Fisher Exact|||||||0.001
73918049|NCT01753856|147364355|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||SL Only, in EC.|Fisher Exact|||||||0.027
73918050|NCT01753856|147364355|SUPERIORITY_OR_OTHER|||||||0.118|TWO_SIDED|||||No Label, in EC.|Fisher Exact|||||||0.118
73918051|NCT01753856|147364355|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and SL, in IC.|Fisher Exact|||||||<0.001
73918052|NCT01753856|147364355|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||SL Only, in IC.|Fisher Exact|||||||0.001
73918053|NCT01753856|147364355|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||No Label, in IC.|Fisher Exact|||||||>0.999
73918054|NCT01753856|147364355|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||DL and SL, in PC.|Fisher Exact|||||||0.002
73918055|NCT01753856|147364355|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||SL Only, in PC.|Fisher Exact|||||||<0.001
73918056|NCT01753856|147364355|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No Label, in PC.|Fisher Exact|||||||<0.001
73918057|NCT01753856|147364356|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
73918058|NCT01753856|147364356|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
73918059|NCT01753856|147364356|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
73918060|NCT01753856|147364357|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918061|NCT01753856|147364357|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918062|NCT01753856|147364357|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918063|NCT01753856|147364357|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||PC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918064|NCT01753856|147364358|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||Remodeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)|||||||0.740
73918065|NCT01753856|147364358|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||Modeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)|||||||0.740
73918066|NCT01753856|147364358|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Remodeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)|||||||0.008
73918067|NCT01753856|147364358|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Modeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)|||||||0.008
73918068|NCT01753856|147364358|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED|||||Remodeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)|||||||0.661
73918069|NCT01753856|147364358|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED|||||Modeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)|||||||0.661
73861085|NCT03710876|147268222|SUPERIORITY||Risk Difference (RD)|2.2||||1|TWO_SIDED|95.0|-25.2|29.2|||Fisher Exact||Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||29.2|-25.2|1.0000
73861086|NCT03710876|147268223|SUPERIORITY||Risk Difference (RD)|-7.6||||0.7665|TWO_SIDED|95.0|-34.9|20.3|||Fisher Exact||Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||20.3|-34.9|0.7665
73861087|NCT03710876|147268224|SUPERIORITY||Risk Difference (RD)|-4.4||||0.7537|TWO_SIDED|95.0|-31.7|23.0||2-sided.|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||23.0|-31.7|0.7537
73861088|NCT03710876|147268225|SUPERIORITY||Risk Difference (RD)|18.4||||0.1855|TWO_SIDED|95.0|-8.8|45.6||2-sided|Chi-squared|Variance calculated by Greenwood's method|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||45.6|-8.8|0.1855
73861089|NCT03710876|147268226|SUPERIORITY||Risk Difference (RD)|12.2||||0.357|TWO_SIDED|95.0|-13.8|38.3||2-sided|Chi-squared|Variance calculated by Greenwood's method|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||38.3|-13.8|0.3570
73861090|NCT03710876|147268227|SUPERIORITY||Risk Difference (RD)|13.5||||0.2856|TWO_SIDED|95.0|-11.3|38.3||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||38.3|-11.3|0.2856
73861091|NCT03710876|147268228|SUPERIORITY||Risk Difference (RD)|6.1||||0.6173|TWO_SIDED|95.0|-17.8|30.0||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||30.0|-17.8|0.6173
73861092|NCT03710876|147268229|SUPERIORITY||Risk Difference (RD)|6.1||||0.6173|TWO_SIDED|95.0|-17.8|30.0||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||30.0|-17.8|0.6173
73861093|NCT02209948|147268233|OTHER|Log Rank (Mantel-Cox)||||||0.943||||||Threshold P-value of 0.05|Log Rank|||||||0.943
73861094|NCT02209948|147268234|OTHER||Hazard Ratio (HR)|1.3||||0.16|TWO_SIDED|95.0|0.9|1.88||Threshold of significance P-value 0.05|Regression, Cox|||||1.88|0.90|0.16
73861095|NCT02209948|147268235|OTHER||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.65|1.5||Threshold for significance P-value 0.05|Regression, Cox|||||1.5|0.65|0.99
73861096|NCT02209948|147268236|OTHER||Hazard Ratio (HR)|1.45||||0.13|TWO_SIDED|95.0|0.89|2.33||threshold for significance 0.05|Regression, Cox|||||2.33|0.89|0.13
73861097|NCT00289198|147268240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.256|||<|0.001|TWO_SIDED|95.0|-1.73|-0.78||Change from Baseline (Day 1) in reflective total nasal symptom scores for Placebo versus that for fluticasone furoate|ANCOVA|||||-0.78|-1.73|<0.001
73861098|NCT00289198|147268241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.459|||<|0.001|TWO_SIDED|95.0|-1.93|-0.99||Mean change from Baseline in AM pre-dose instantaneous TNSS over entire period for Placebo versus that for Fluticasone furoate|ANCOVA|||||-0.99|-1.93|<0.001
73861099|NCT00289198|147268242|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|Based on logistic regression adjusting for age, gender and country||||||<0.001
73861100|NCT00289198|147268243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.274|||<|0.001|TWO_SIDED|95.0|-1.74|-0.81|||ANCOVA|||||-0.81|-1.74|<0.001
73861101|NCT00289198|147268244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.291|||<|0.001|TWO_SIDED|95.0|-1.77|-0.81|||ANCOVA|||||-0.81|-1.77|<0.001
73861102|NCT00289198|147268245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.118|||<|0.001|TWO_SIDED|95.0|-20.03|-8.21|||ANCOVA|||||-8.21|-20.03|<0.001
73861103|NCT00289198|147268246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.033|||<|0.001|TWO_SIDED|95.0|-27.13|-12.94|||ANCOVA|||||-12.94|-27.13|<0.001
73861104|NCT00289198|147268247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||<|0.001|TWO_SIDED|95.0|-0.41|-0.14|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate||-0.14|-0.41|<0.001
73861105|NCT00289198|147268247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Nasal Congestion, Placebo vs Fluticasone furoate||-0.14|-0.42|<0.001
73861106|NCT00289198|147268247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.331|||<|0.001|TWO_SIDED|95.0|-0.47|-0.2|||ANCOVA|||Nasal Itching, Placebo vs Fluticasone furoate||-0.20|-0.47|<0.001
73861107|NCT00289198|147268247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.52|-0.27|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate||-0.27|-0.52|<0.001
73861108|NCT00289198|147268248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357||||0.001|TWO_SIDED|95.0|-0.5|-0.22|||ANCOVA|||Rhinorrhea score, Placebo versus fluticasone furoate||-0.22|-0.50|0.001
73861109|NCT00289198|147268248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.001|TWO_SIDED|95.0|-0.51|-0.23|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate||-0.23|-0.51|0.001
73861110|NCT00289198|147268248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.372||||0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate||-0.24|-0.50|0.001
73861111|NCT00289198|147268248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.372||||0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate||-0.24|-0.50|0.001
73861112|NCT00289198|147268249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.281||||0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Rhinorrhea score,Placebo versus fluticasone furoate||-0.14|-0.42|0.001
73861113|NCT00289198|147268249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.314||||0.001|TWO_SIDED|95.0|-0.45|-0.17|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate||-0.17|-0.45|0.001
73861114|NCT00289198|147268249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.324||||0.001|TWO_SIDED|95.0|-0.45|-0.19|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate||-0.19|-0.45|0.001
73918070|NCT01753856|147364360|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
74088419|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|0.1532|STANDARD_ERROR_OF_MEAN|0.1896||0.4219||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of total number of lifetime sex partners (0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.4219
73861115|NCT00289198|147268249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.374||||0.001|TWO_SIDED|95.0|-0.5|-0.25|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate||-0.25|-0.50|0.001
73861116|NCT00289198|147268250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.292|||<|0.001||95.0|-0.43|-0.15|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate||-0.15|-0.43|<0.001
73861117|NCT00289198|147268250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.264|||<|0.001|TWO_SIDED|95.0|-0.4|-0.12|||ANCOVA|||Nasal Congestion score, Placebo vs Fluticasone furoate||-0.12|-0.40|<0.001
73861118|NCT00289198|147268250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.336|||<|0.001|TWO_SIDED|95.0|-0.48|-0.2|||ANCOVA|||Nasal Itching score, Placebo vs Fluticasone furoate||-0.20|-0.48|<0.001
73861119|NCT00289198|147268250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.412|||<|0.001|TWO_SIDED|95.0|-0.54|-0.28|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate||-0.28|-0.54|<0.001
73861120|NCT00289198|147268251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.506||||0.004|TWO_SIDED|95.0|-0.85|-0.16|||ANCOVA|||||-0.16|-0.85|0.004
73861121|NCT00289198|147268252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.491||||0.007||95.0|-0.85|-0.13|||ANCOVA|||||-0.13|-0.85|0.007
73861122|NCT00289198|147268253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.531||||0.003|TWO_SIDED|95.0|-0.88|-0.19|||ANCOVA|||||-0.19|-0.88|0.003
73861123|NCT00289198|147268254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.496||||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||||-0.15|-0.84|0.005
73861124|NCT00289198|147268255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.216||||0.001|TWO_SIDED|95.0|-0.34|-0.09|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate||-0.09|-0.34|0.001
73861125|NCT00289198|147268255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.137||||0.028|TWO_SIDED|95.0|-0.26|-0.02|||ANCOVA|||Eye tearing/watering score, Placebo vs fluticasone furoate||-0.02|-0.26|0.028
73861126|NCT00289198|147268255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.156||||0.01|TWO_SIDED|95.0|-0.27|-0.04|||ANCOVA|||Eye redness, Placebo vs fluticasone furoate||-0.04|-0.27|0.010
73861127|NCT00289198|147268256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215||||0.002|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate||-0.08|-0.35|0.002
73861128|NCT00289198|147268256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.161||||0.016||95.0|-0.29|-0.03|||ANCOVA|||Eye tearing or watering, Placebo vs fluticasone furoate||-0.03|-0.29|0.016
73861129|NCT00289198|147268256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113||||0.076|TWO_SIDED|95.0|-0.24|-0.01|||ANCOVA|||Eye redness score, Placebo vs fluticasone furoate||-0.01|-0.24|0.076
73861130|NCT00289198|147268257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.211||||0.001|TWO_SIDED|95.0|-0.34|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs Fluticasone furoate||-0.08|-0.34|0.001
73861131|NCT00289198|147268257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145||||0.023|TWO_SIDED|95.0|-0.27|-0.02|||ANCOVA|||Eye tearing/watering, Placebo vs Fluticasone furoate||-0.02|-0.27|0.023
73861132|NCT00289198|147268257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176||||0.005|TWO_SIDED|95.0|-0.3|-0.05|||ANCOVA|||Eye Redness score, Placebo vs Fluticasone furoate||-0.05|-0.30|0.005
73861133|NCT00289198|147268258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.223||||0.001|TWO_SIDED|95.0|-0.35|-0.09|||ANCOVA|||Eye itching/burning, Placebo vs fluticasone furoate||-0.09|-0.35|0.001
73861134|NCT00289198|147268258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.04|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Eye Tearing/Watering score, Placebo vs fluticasone furoate||-0.01|-0.25|0.040
73861135|NCT00289198|147268258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.142||||0.022|TWO_SIDED|95.0|-0.26|-0.02|||ANCOVA|||Eye Redness score, Placebo vs fluticasone furoate||-0.02|-0.26|0.022
73861136|NCT00289198|147268259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.376||||0.004|TWO_SIDED|95.0|2.71|14.04|||ANCOVA|||||14.04|2.71|0.004
73861137|NCT00289198|147268260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.28||||0.002|TWO_SIDED|95.0|3.52|15.04|||ANCOVA|||||15.04|3.52|0.002
73861138|NCT00289198|147268261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.638||||0.009|TWO_SIDED|95.0|1.89|13.39|||ANCOVA|||||13.39|1.89|0.009
73861139|NCT02406443|147268277|SUPERIORITY||Mean Difference (Final Values)|46.0|||=|0.012|TWO_SIDED||||||Regression, Linear|||||||=0.012
73861140|NCT02406443|147268278|SUPERIORITY||Median Difference (Final Values)|5.7||||0.4|TWO_SIDED||||||Regression, Linear|||||||0.40
73861141|NCT02406443|147268279|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.15|TWO_SIDED||||||Regression, Linear|||||||0.15
73861142|NCT02406443|147268280|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
73861143|NCT02406443|147268281|SUPERIORITY||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
73861144|NCT02406443|147268282|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.42|TWO_SIDED||||||Regression, Linear|||||||0.42
73861145|NCT01804582|147268348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Mixed Models Analysis|||An intent to treat analysis was conducted using a linear mixed model to determine if there was any significant difference in change from baseline to 3 months based on time and condition. Data for all participants was included at baseline and 3 months.||||.15
73861146|NCT01804582|147268349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.53|TWO_SIDED||||||Mixed Models Analysis||Cohen's d was calculated to measure the estimation parameter.|||||.53
73861147|NCT01804582|147268350|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||.80
73861148|NCT01804582|147268351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|||||||Mixed Models Analysis|||||||.33
73861149|NCT01804582|147268352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Wald Chi-Squared|||||||.21
73918071|NCT01753856|147364360|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918072|NCT01753856|147364360|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||PC.|Wilcoxon (Mann-Whitney)|||||||0.740
73918073|NCT01753856|147364361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918074|NCT01753856|147364361|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.004
73918075|NCT01753856|147364361|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918076|NCT01753856|147364361|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.850
73918077|NCT01753856|147364362|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.004
73918078|NCT01753856|147364362|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in the CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918079|NCT01753856|147364362|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918080|NCT01753856|147364362|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918081|NCT01753856|147364362|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
74027749|NCT00401973|147608851|SUPERIORITY_OR_OTHER|||||||0.474||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.474
74027750|NCT00401973|147608851|SUPERIORITY_OR_OTHER|||||||0.404||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.404
74086482|NCT00292227|147726498|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.37||||||90.0|-2.13|1.39|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.39|-2.13|
73918082|NCT01753856|147364362|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918083|NCT01753856|147364362|SUPERIORITY_OR_OTHER|||||||0.931|TWO_SIDED|||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.931
73918084|NCT01753856|147364362|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED|||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.549
73918085|NCT01753856|147364363|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918086|NCT01753856|147364363|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918087|NCT01753856|147364363|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918088|NCT01753856|147364363|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918089|NCT01753856|147364363|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918090|NCT01753856|147364363|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918091|NCT01753856|147364363|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918092|NCT01753856|147364363|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918093|NCT01753856|147364364|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918094|NCT01753856|147364364|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918095|NCT01753856|147364364|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918096|NCT01753856|147364364|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918097|NCT01753856|147364364|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918098|NCT01753856|147364364|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
73918099|NCT01753856|147364364|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
74027751|NCT00401973|147608851|SUPERIORITY_OR_OTHER|||||||0.652||95.0||||P-value for Change from Baseline|ANCOVA|||||||0.652
74088420|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.7752|STANDARD_ERROR_OF_MEAN|0.242||0.002||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.0020
73918100|NCT01753856|147364364|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||dLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.028
73918101|NCT01753856|147364365|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918102|NCT01753856|147364365|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918103|NCT01753856|147364365|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918104|NCT01753856|147364366|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918105|NCT01753856|147364366|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918106|NCT01753856|147364366|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918107|NCT01753856|147364367|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918108|NCT01753856|147364367|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918109|NCT01753856|147364367|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918110|NCT01753856|147364368|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918111|NCT01753856|147364368|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918112|NCT01753856|147364368|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
74088421|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|0.2921|STANDARD_ERROR_OF_MEAN|0.2086||0.1659||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.1659
73918113|NCT01753856|147364369|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918114|NCT01753856|147364369|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918115|NCT01753856|147364369|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918116|NCT01753856|147364369|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918117|NCT01753856|147364369|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918118|NCT01753856|147364369|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918119|NCT01753856|147364370|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||DL Only, in CC.|Wilcoxon (Mann-Whitney)|||||||0.002
73918120|NCT01753856|147364370|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918121|NCT01753856|147364370|SUPERIORITY_OR_OTHER|||||||0.214|TWO_SIDED|||||DL Only, in EC.|Wilcoxon (Mann-Whitney)|||||||0.214
73918122|NCT01753856|147364370|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)|||||||0.031
73918123|NCT01753856|147364370|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918124|NCT01753856|147364370|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918125|NCT01753856|147364371|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73918126|NCT01753856|147364372|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918127|NCT01753856|147364372|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918128|NCT01753856|147364372|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918129|NCT01753856|147364373|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918130|NCT01753856|147364373|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918131|NCT01753856|147364373|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918132|NCT01753856|147364374|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Average length of DLs in the CC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
73918133|NCT01753856|147364374|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||Average length of double labels in EC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||0.004
73918134|NCT01753856|147364374|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Average length of double labels in IC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
73918135|NCT01753856|147364374|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|||||Average length of double labels in the PC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||0.850
73918136|NCT01753856|147364375|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
73918137|NCT01753856|147364375|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||0.042
73918138|NCT01753856|147364375|SUPERIORITY_OR_OTHER|||||||0.678|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||0.678
73918139|NCT01753856|147364376|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC|Wilcoxon (Mann-Whitney)|||||||<0.001
73918140|NCT01753856|147364376|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC|Wilcoxon (Mann-Whitney)|||||||<0.001
73918141|NCT01753856|147364376|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC|Wilcoxon (Mann-Whitney)|||||||<0.001
73918142|NCT00064844|147364380|SUPERIORITY_OR_OTHER_LEGACY||chi square|7.25|||<|0.01||95.0|||||Chi-squared|df = 1, N = 96||||||<0.01
73918143|NCT04847557|147364448|SUPERIORITY||Median Difference (Net)|6.9|||<|0.001|TWO_SIDED|95.0|3.3|10.6|||Stratified Wilcoxon|Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \& baseline BMI|The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.|||10.6|3.3|<0.001
73918144|NCT04847557|147364449|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.026|TWO_SIDED|95.0|0.41|0.95|||Regression, Cox|||Heart Failure Outcomes||0.95|0.41|0.026
73861150|NCT01804582|147268353|SUPERIORITY_OR_OTHER_LEGACY||Phi|0.19||||0.005|TWO_SIDED||||||Chi-squared|Chi Squared (1, N = 229) = 7.99.||The total n=229 included those on medication at 90 days (119 never filled the prescription or changed to a different med)||||.005
73861151|NCT01891344|147268378|SUPERIORITY||Cox Proportional Hazard|0.273|||||TWO_SIDED|95.0|0.17|0.437||||||||0.437|0.170|
73861152|NCT01891344|147268378|SUPERIORITY||Cox Proportional Hazard|0.61|||||TWO_SIDED|95.0|0.428|0.871||||||||0.871|0.428|
73861153|NCT01605227|147268443|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.213|TWO_SIDED|95.0|0.76|1.06|||Log Rank|The Log-Rank test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.||||1.06|0.76|0.213
73861154|NCT01605227|147268444|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.||||||<0.001
73861155|NCT01605227|147268445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.4|0.57|||Log Rank|The Log-Rank Test was stratified by prior cabazitaxel, baseline pain severity, and baseline Eastern Cooperative Oncology Group Performance Status.||||0.57|0.40|<0.001
73861156|NCT02961790|147268446|SUPERIORITY|||||||0.0041|||||||Kruskal-Wallis|||||||0.0041
73861157|NCT02961790|147268446|SUPERIORITY|||||||0.0001|||||||Kruskal-Wallis|||||||0.0001
73861158|NCT02961790|147268447|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.||||||<0.0001
73861159|NCT02961790|147268448|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.||||||<0.0001
73861160|NCT02961790|147268449|SUPERIORITY|||||||0.0174|||||||Kruskal-Wallis|||||||0.0174
73861161|NCT02961790|147268449|SUPERIORITY|||||||0.0279|||||||Kruskal-Wallis|||||||0.0279
73861162|NCT02961790|147268450|SUPERIORITY|||||||0.0011|||||||Kruskal-Wallis|||||||0.0011
73861163|NCT02961790|147268450|SUPERIORITY|||||||0.0025|||||||Kruskal-Wallis|||||||0.0025
73861164|NCT02042534|147268458|SUPERIORITY_OR_OTHER|||||||0.6765|||||||Chi-squared|||||||0.6765
73861165|NCT02042534|147268459|SUPERIORITY_OR_OTHER|||||||0.3753|||||||Chi-squared|||||||0.3753
73861166|NCT02042534|147268460|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||<.0001
73861167|NCT02042534|147268461|SUPERIORITY_OR_OTHER|||||||0.3301|||||||Cochran-Mantel-Haenszel|||||||0.3301
73861168|NCT03093974|147268462|SUPERIORITY|The number of NCFB pulmonary exacerbations was compared between treatment groups using a negative binomial model including treatment, pooled site (country) and baseline use of stable concomitant therapy with oral macrolides as fixed effects and log-time on treatment as an offset.|LS Mean rate ratio|0.612||||0.00101|TWO_SIDED|95.0|0.457|0.82|||two-sided Wald chi-square test|||||0.820|0.457|0.00101
73861169|NCT01479595|147268507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.514||||0.005|TWO_SIDED|90.0|-0.811|-0.217|||Mixed Models Analysis|||||-0.217|-0.811|0.005
73861170|NCT05268744|147268518|SUPERIORITY|Since all outcomes were normally distributed, one-sided paired t-test was used to compare mean pre- and post-treatment scores to see whether post-treatment scores of ABI-S and SRS had improved compared to pre-treatment scores|||||<|0.05|||||||t-test, 1 sided|||Null hypothesis was no improvement in mean ABI-S and SRS scores at the end of the study, compared to baseline||||<0.05
73861171|NCT02120365|147268523|SUPERIORITY||Mean Difference (Final Values)|0.729|STANDARD_ERROR_OF_MEAN|1.986||0.867|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|Medication dose was a within-subjects factor (crossover design)||||0.867
73861172|NCT02120365|147268524|SUPERIORITY||Mean Difference (Final Values)|5.514|STANDARD_ERROR_OF_MEAN|3.038||0.071|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|mixed models, medication was a within-subjects factor||||0.071
73861173|NCT02120365|147268525|SUPERIORITY||Mean Difference (Final Values)|0.729|STANDARD_ERROR_OF_MEAN|2.905||0.667|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|mixed models||||0.667
73861174|NCT02120365|147268526|SUPERIORITY||Mean Difference (Final Values)|2.242|STANDARD_ERROR_OF_MEAN|1.393||0.285|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|||||0.285
73861175|NCT02120365|147268527|SUPERIORITY||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.408||0.843|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|Mixed Models||||.843
73861176|NCT02120365|147268528|SUPERIORITY||Mean Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|2.07||0.691|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|We report the main effect of dose on the outcome measure||||.691
73861177|NCT01726673|147268529|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|302.0||||0.256|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.256
73861178|NCT01726673|147268529|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with upper extremity fugl meyer score for the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|222.0||||0.222|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 36 weeks (follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.222
73861179|NCT01726673|147268530|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U Value|251.5||||1|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||1.0
74027752|NCT01954628|147608880|SUPERIORITY_OR_OTHER||Least sqaure mean difference|23.7||||0.759|TWO_SIDED|95.0|-128.3|175.7||AAC were compared between treatments using an analysis of variance model adjusting for treatment and region as factors and including the baseline score as a covariate.|ANOVA|||Sample size based on area above the daily EXACT score curve (AAC) from Day 1 to Day 29 from subjects with an acute COPD exacerbation, collected over 28 days. Assuming a residual SD of 500 points, a sample size of 200 subjects per arm would be expected to have an 80% power to detect a true treatment difference in the AAC of 140 points over 12-weeks treatment, using a 2-sided test; alpha-level of 0.05.This difference corresponds to a mean daily improvement of 1.67 points on the EXACT symptom score||175.7|-128.3|0.759
74086483|NCT00292227|147726499|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.68||||||90.0|-2.6|1.25|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.25|-2.60|
74086484|NCT00292227|147726500|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.17||||||90.0|-0.69|3.03|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.03|-0.69|
73918145|NCT04847557|147364450|SUPERIORITY||Median Difference (Net)|18.3|||<|0.001|TWO_SIDED|95.0|9.9|26.7|||Stratified Wilcoxon|Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \& baseline BMI|The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.|||26.7|9.9|<0.001
73918146|NCT04847557|147364451|SUPERIORITY||LS Mean Difference|-11.62|||<|0.001|TWO_SIDED|95.0|-12.85|-10.38|||ANCOVA|||||-10.38|-12.85|<0.001
73918147|NCT04847557|147364452|SUPERIORITY||LS Mean Difference|-34.91|||<|0.001|TWO_SIDED|95.0|-45.6|-22.17|||ANCOVA|||||-22.17|-45.60|<0.001
73918148|NCT04847557|147364453|SUPERIORITY||Win Ratio|1.63|||||TWO_SIDED|95.0|1.17|2.28|||||The win ratio was reported as the measure of treatment effect based on the principle that each participant is compared with every other participant within each stratum in a pair-wise manner that proceeds in a hierarchical fashion.|||2.28|1.17|
73918149|NCT04847557|147364454|SUPERIORITY||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|1.53|3.4||||||||3.40|1.53|
73918150|NCT04847557|147364455|SUPERIORITY||Hazard Ratio (HR)|1.245|||||TWO_SIDED|95.0|0.633|2.452||||||||2.452|0.633|
73918151|NCT04847557|147364456|SUPERIORITY||Hazard Ratio (HR)|0.539|||||TWO_SIDED|95.0|0.342|0.85||||||||0.850|0.342|
73918152|NCT04847557|147364457|SUPERIORITY||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.46|1.14||||||||1.14|0.46|
73918153|NCT04847557|147364458|SUPERIORITY||Rate Ratio|0.62|||||TWO_SIDED|95.0|0.37|1.05||||||||1.05|0.37|
73918154|NCT01549860|147364475|SUPERIORITY_OR_OTHER||||||<|0.024|TWO_SIDED||||||t-test, 2 sided|||||||<0.024
73918155|NCT01549860|147364477|SUPERIORITY_OR_OTHER||||||<|0.0126|TWO_SIDED|||||The MIST+SOC subjects decreased in their reported mean pain scores and reduced from a median of 3.0 to 0.6 cm after four weeks of study treatment.|ANCOVA|||||||<0.0126
73918156|NCT00720434|147364481|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.36357||||0.0131|TWO_SIDED|95.0|-4.19228|-0.53485|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95 percentage (%) confidence interval (CI) were calculated.||-0.53485|-4.19228|0.0131
73918157|NCT00720434|147364481|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4919||||0.0142|TWO_SIDED|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53760|-4.44619|0.0142
73918158|NCT00720434|147364481|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.46325||||0.1368|TWO_SIDED|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.49248|-3.41898|0.1368
73918159|NCT00720434|147364481|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.90032||||0.3321|TWO_SIDED|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.96648|-2.76711|0.3321
73918160|NCT00720434|147364481|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.02865||||0.2839|TWO_SIDED|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.89844|-2.95573|0.2839
73918161|NCT00720434|147364481|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12833||||0.8891|TWO_SIDED|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||1.99342|-1.73676|0.8891
73918162|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.6|||||TWO_SIDED|95.0|0.1565|0.8785||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.8785|0.1565|
74086485|NCT00292227|147726501|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.8||||||90.0|-1.14|2.73|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.73|-1.14|
74086486|NCT00292227|147726502|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.42||||||90.0|-2.33|1.5|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.50|-2.33|
73918163|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.75|||||TWO_SIDED|95.0|0.233|0.969||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.9690|0.2330|
73918164|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.625|||||TWO_SIDED|95.0|0.0871|0.9191||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.9191|0.0871|
73918165|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.025|||||TWO_SIDED|95.0|-0.4769|0.4336||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.4336|-0.4769|
73918166|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125||||||95.0|-0.4024|0.6049||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
73918167|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.15|||||TWO_SIDED|95.0|-0.5729|0.3149||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3149|-0.5729|
73918168|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.3|||||TWO_SIDED|95.0|-0.1836|0.6931||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6931|-0.1836|
73918169|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.375|||||TWO_SIDED|95.0|-0.1732|0.7797||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.7797|-0.1732|
73918170|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
73918171|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.175|||||TWO_SIDED|95.0|-0.2934|0.5917||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5917|-0.2934|
73918172|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25|||||TWO_SIDED|95.0|-0.2913|0.696||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6960|-0.2913|
73918173|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.075|||||TWO_SIDED|95.0|-0.5144|0.388||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3880|-0.5144|
73918174|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.1|||||TWO_SIDED|95.0|-0.3728|0.5414||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5414|-0.3728|
73918175|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25|||||TWO_SIDED|95.0|-0.2913|0.696||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6960|-0.2913|
73918176|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
73918177|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.025||||||95.0|-0.4769|0.4336||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.4336|-0.4769|
73918178|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
73918179|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.15|||||TWO_SIDED|95.0|-0.5729|0.3149||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3149|-0.5729|
73918180|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
73918181|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
73918182|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
73918183|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
73918184|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
73918185|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
73918186|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
73918187|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
73918188|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
73918189|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
73966768|NCT03526861|147470369|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|20.3|||<|0.001|TWO_SIDED|95.0|9.7|31.0||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||31.0|9.7|<0.001
73971398|NCT03974178|147483461|OTHER|The hypothesis H0 (pfailure at the end of hospitalization = 9% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|0.0||||0.0405|TWO_SIDED|90.0|0.0|8.43||The rate of failures at the end of hospitalization was compared to the predefined unacceptable rate of 9%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at the end of hospitalization (pfailure) is compared to the threshold of 9%, with H0 being pfailure = 9% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||8.43|0|0.0405
74086487|NCT00292227|147726503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||||95.0|-1.04|1.71|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||1.71|-1.04|
74086488|NCT00292227|147726504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||||95.0|-0.72|1.68|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||1.68|-0.72|
73918190|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
73918191|NCT00720434|147364482|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
73918192|NCT00720434|147364485|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.36357||||0.0131|TWO_SIDED|95.0|-4.19228|-0.53485|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53485|-4.19228|0.0131
73918193|NCT00720434|147364485|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4919||||0.0142|TWO_SIDED|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53760|-4.44619|0.0142
73918194|NCT00720434|147364485|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.46325||||0.1368|TWO_SIDED|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.49248|-3.41898|0.1368
73918195|NCT00720434|147364485|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.90032||||0.3321|TWO_SIDED|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.96648|-2.76711|0.3321
73918196|NCT00720434|147364485|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.02865||||0.2839|TWO_SIDED|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.89844|-2.95573|0.2839
74086489|NCT00292227|147726505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.51||||||95.0|0.3|2.73|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||2.73|0.30|
74086490|NCT00292227|147726506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.5||||||95.0|11.78|15.22|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||15.22|11.78|
74086491|NCT00292227|147726507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.02||||||95.0|9.12|12.93|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||12.93|9.12|
74086492|NCT00292227|147726508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.3||||||95.0|9.94|12.67|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||12.67|9.94|
73918197|NCT00720434|147364485|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12833||||0.8891|TWO_SIDED|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||1.99342|-1.73676|0.8891
73918198|NCT01571427|147364488|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.35||0.25|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.25
73918199|NCT01571427|147364488|EQUIVALENCE|Power calculation was based on the entire sample (CDR=0 and CDR=0.5 combined). Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.42||0.25|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)||||0.25
73918200|NCT01571427|147364488|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.62||0.85|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: AMONG CDR=0.5 (Mild Cognitive Impairment) group, N=34 .||||0.85
73971399|NCT03974178|147483462|OTHER|The hypothesis H0 (pfailure at 12 months = 12% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|2.94||||0.073|TWO_SIDED|90.0|0.15|13.21||The rate of failures at 12 months was compared to the predefined unacceptable rate of 12%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at 12 months (pfailure) is compared to the threshold of 12%, with H0 being pfailure = 12% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||13.21|0.15|0.0730
74088422|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-1.6163|STANDARD_ERROR_OF_MEAN|0.2839||0||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.0000
73918201|NCT01571427|147364489|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.92||0.02|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.02
73918202|NCT01571427|147364489|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|1.28||0.003|TWO_SIDED|||||Statistically significant based on the Bonferroni multiple comparison adjusted P value of P\<0.004.|Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)||||0.003
73918203|NCT01571427|147364489|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|1.14||0.65|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: CDR=0.5 (Mild Cognitive Impairment) group, N=34||||0.65
73918204|NCT01571427|147364490|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.33||0.98|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.98
73918205|NCT01571427|147364490|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|1.63||0.96|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: Among CDR 0 (n=49)||||0.96
73918206|NCT01571427|147364490|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.38||0.83|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: Among CDR 0.5 (n=34)||||0.83
73918207|NCT01571427|147364491|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.64||0.68|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.68
73918208|NCT01571427|147364491|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.84||0.69|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.69
73918209|NCT01571427|147364491|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|1.02||0.86|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.86
73918210|NCT01571427|147364492|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.43||0.92|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.92
73918211|NCT01571427|147364492|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.61||0.92|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.92
74086493|NCT00292227|147726509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.28||||||95.0|6.85|9.7|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||9.70|6.85|
73918212|NCT01571427|147364492|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.62||0.94|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.94
73918213|NCT01571427|147364493|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|2.84||0.46|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.46
74086494|NCT00292227|147726510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.3||||||95.0|7.57|11.02|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||11.02|7.57|
73918214|NCT01571427|147364493|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|2.08||0.61|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.61
73918215|NCT01571427|147364493|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|6.42||0.8|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.80
73918216|NCT01571427|147364494|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|8.88||0.72|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.72
73918217|NCT01571427|147364494|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|11.1||0.84|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.84
73966769|NCT03526861|147470369|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|21.8|||<|0.001|TWO_SIDED|95.0|10.9|32.7||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.7|10.9|<0.001
73966770|NCT03526861|147470370|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-6.0|||<|0.001|TWO_SIDED|95.0|-8.4|-3.6||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-3.6|-8.4|<0.001
73966771|NCT03526861|147470370|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-5.4|||<|0.001|TWO_SIDED|95.0|-7.9|-3.0||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-3.0|-7.9|<0.001
73966772|NCT02814838|147470444|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.3303|TWO_SIDED|95.0|-0.14|0.42|||Student's t test for unpaired samples|||Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.||0.42|-0.14|0.3303
73966773|NCT02814838|147470445|SUPERIORITY|The comparisons between groups on 2-hour AUC C-peptide efficacy endpoint was carried-out using a mixed linear model where the log(x+1) transformed 2-hour AUC C-peptide was the dependent variable, while treatment group, visit, treatment by visit interaction were the fixed factors of the model and patient will be the random effect. An unstructured covariance matrix for each patient is considered and the Kenward-Roger adjustment is used for the degrees of freedom.|adjusted mean difference|0.0984||||0.517|TWO_SIDED|95.0|-0.2028|0.3995|||Mixed Models Analysis|||at FUP week 26||0.3995|-0.2028|0.517
73966774|NCT02814838|147470445|SUPERIORITY|The comparisons between groups on 2-hour AUC C-peptide efficacy endpoint was carried-out using a mixed linear model where the log(x+1) transformed 2-hour AUC C-peptide was the dependent variable, while treatment group, visit, treatment by visit interaction were the fixed factors of the model and patient will be the random effect. An unstructured covariance matrix for each patient is considered and the Kenward-Roger adjustment is used for the degrees of freedom.|adjusted mean difference|-0.0486||||0.7999|TWO_SIDED|95.0|-0.4294|0.3322|||Mixed Models Analysis|||At FUP week 52||0.3322|-0.4294|0.7999
74086495|NCT00292227|147726511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.87||||||95.0|7.47|10.28|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||10.28|7.47|
73918218|NCT01571427|147364494|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|12.39|STANDARD_ERROR_OF_MEAN|14.4||0.4|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.40
73918219|NCT01571427|147364495|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.91||0.38|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.38
73918220|NCT01571427|147364495|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.31||0.39|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.39
73918221|NCT01571427|147364495|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.26||0.59|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.59
74086496|NCT00292227|147726512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.6||||||95.0|7.25|9.96|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||9.96|7.25|
73918222|NCT01571427|147364496|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.03|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.03
73918223|NCT01571427|147364496|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.24|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.24
73918224|NCT01571427|147364496|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.04|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.04
73918225|NCT01571427|147364497|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.65|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.65
73918226|NCT01571427|147364497|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.64|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.64
74086497|NCT00292227|147726513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.52||||||95.0|6.31|8.72|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||8.72|6.31|
74088423|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.1788|STANDARD_ERROR_OF_MEAN|0.2463||0.4701||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.4701
73918227|NCT01571427|147364497|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.42|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.42
73918228|NCT01571427|147364498|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.45||0.45|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.45
73918229|NCT01571427|147364498|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.05||0.93|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.93
73918230|NCT01571427|147364498|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.40
73918231|NCT01571427|147364499|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.09||0.3|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.30
73918232|NCT01571427|147364499|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.75|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.75
73918233|NCT01571427|147364499|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.15||0.12|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.12
73918234|NCT04493281|147364500|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-t for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||||1.04|0.91|
73918235|NCT04493281|147364501|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-inf for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|0.98|||||TWO_SIDED|90.0|0.92|1.04||||||||1.04|0.92|
73918236|NCT04493281|147364502|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of Cmax for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|1.22|||||TWO_SIDED|90.0|1.09|1.36||||||||1.36|1.09|
73918237|NCT00869206|147364547|NON_INFERIORITY_OR_EQUIVALENCE|Based on the published data on the effect of a standard of dosing schedule of \> zoledronic acid compared to placebo, we choose ∆= 7%, πT= 42%, and πS= 35%. With a total of 1230 eligible patients (615 per arm), the probability of rejecting the null hypothesis using a one-sided test is at most 0.05 (Type I error α) when θ≥ 7% and the probability of rejecting the null hypothesis (the power) is at least 82% when θ≤0|||||<=|0.05|||||||Cochran-Mantel-Haenszel|||||||<=.05
73918238|NCT00869206|147364548|SUPERIORITY_OR_OTHER||Slope|-0.00394|STANDARD_ERROR_OF_MEAN|0.00962||0.68|TWO_SIDED||||||Mixed Models Analysis|Model is adjusted for tumor type, baseline creatinine, prior SREs, prior bisphosphonates, age, gender, race, BSA, and baseline performance status||||||0.68
73918239|NCT00869206|147364549|SUPERIORITY_OR_OTHER||Slope|0.0016|STANDARD_ERROR_OF_MEAN|0.0034||0.64|TWO_SIDED||||||Mixed Models Analysis|Adjusted for tumor type, baseline creatinine, prior SRE, prior bisphosphonates, age, gender, BSA, race, and baseline performance status||||||0.64
73918240|NCT00869206|147364551|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.1|TWO_SIDED|95.0|-0.3|1.7|||Cochran-Mantel-Haenszel|||||1.7|-0.3|0.10
73966775|NCT02814838|147470446|SUPERIORITY||adjusted mean difference|12.0411||||0.2224|TWO_SIDED|95.0|-7.3823|31.4644|||Mixed Models Analysis|||at week 13||31.4644|-7.3823|0.2224
73966776|NCT02814838|147470446|SUPERIORITY||adjusted mean difference|8.4803||||0.3931|TWO_SIDED|95.0|-11.0935|28.0541|||Mixed Models Analysis|||At week 26||28.0541|-11.0935|0.3931
73966777|NCT02814838|147470446|SUPERIORITY||adjusted mean difference|-2.9502||||0.7664|TWO_SIDED|95.0|-22.5476|16.6473|||Mixed Models Analysis|||At week 52||16.6473|-22.5476|0.7664
74086498|NCT00292227|147726514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.58||||||95.0|6.21|8.95|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||8.95|6.21|
74086499|NCT00292227|147726515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.19||||||95.0|4.94|7.45|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||7.45|4.94|
73918241|NCT02254486|147364599|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|0.14||||0.528|ONE_SIDED|97.5|-8.15|||P-value adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-8.15|0.528
73918242|NCT02254486|147364600|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|6.58||||0.059|ONE_SIDED|97.5|-1.69|||P-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority and with 1-sided p-value \<0.025; the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-1.69|0.059
73918243|NCT02254486|147364601|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-3.01||||0.863|TWO_SIDED|95.0|-11.36|5.28||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||5.28|-11.36|0.863
73918244|NCT02254486|147364602|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.66||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||||0.660
73918245|NCT02254486|147364603|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.953||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - Trisulfate Solution rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||||0.953
73918246|NCT02254486|147364604|NON_INFERIORITY_OR_EQUIVALENCE|Formal hierarchical testing of this key secondary endpoints was not performed due to the results of the non-inferiority analysis.||||||0.781|||||||Fisher Exact|||If at least one of the alternative primary endpoints were met, then key secondary endpoints were evaluated hierarchichally in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit (CL) for difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of Trisulate Solution. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||||0.781
73918247|NCT01979016|147364663|SUPERIORITY||Least Squares (LS) Mean Difference|-69.4|||<|0.0001|TWO_SIDED|95.0|-92.5|-46.2|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a mixed model repeated measures (MMRM) model.||-46.2|-92.5|< 0.0001
73918248|NCT01979016|147364664|SUPERIORITY||Percentage difference|37.0|||=|0.0006|TWO_SIDED|95.0|18.82|55.25|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||55.25|18.82|= 0.0006
74027753|NCT01954628|147608881|SUPERIORITY_OR_OTHER||Least sqaure mean difference|-0.34||||0.588|TWO_SIDED|95.0|-1.57|0.89|||ANOVA|||ANOVA model with fixed factors treatment, region and baseline total CAT score as covariate were used. Missing post-treatment data were imputed using the Last Observation Carried Forward principle.||0.89|-1.57|0.588
74027754|NCT01954628|147608882|SUPERIORITY_OR_OTHER||Least sqaure mean difference|1.083||||0.646|TWO_SIDED|95.0|0.771|1.52|||Negative binomial regression model|Negative binomial regression model with fixed factors treatment, region and time in study as offset.||The number of subjects with at least one COPD exacerbation were summarised by treatment group.||1.520|0.771|0.646
74027755|NCT01954628|147608885|SUPERIORITY_OR_OTHER|||||||0.226|||||||ANOVA|||Missing post-treatment data was imputed using the Last Observation Carried Forward principle.||||0.226
74027756|NCT04329923|147608887|SUPERIORITY||Cox Proportional Hazard|0.58||||0.28|TWO_SIDED||||||Regression, Cox|||||||0.28
74027757|NCT01272180|147608892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|16.0|||||TWO_SIDED|95.0|5.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine.||29|5|
74027758|NCT01272180|147608892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between MenABCWY and MenACWY groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|32.0|||||TWO_SIDED|95.0|21.0|44.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.||44|21|
74086500|NCT02093923|147726523|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
74086501|NCT02093923|147726523|SUPERIORITY||Percent Change in Mean Rate|-87.77||||0.005|TWO_SIDED|95.0|-97.18|-46.9|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-46.90|-97.18|0.0050
74086502|NCT02093923|147726523|SUPERIORITY||Percent Change in Mean Rate|-91.08||||0.0012||95.0|-97.93|-61.57|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-61.57|-97.93|0.0012
73918249|NCT01979016|147364665|SUPERIORITY||Percentage difference|48.1|||<|0.0001|TWO_SIDED|95.0|28.0|68.3|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||68.30|28.00|< 0.0001
73918250|NCT01979016|147364666|SUPERIORITY||LS Mean Difference|-2.66|||<|0.0001|TWO_SIDED|95.0|-3.8|-1.52|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-1.52|-3.80|< 0.0001
73918251|NCT01979016|147364667|SUPERIORITY||LS Mean Difference|-48.08|||=|0.0001|TWO_SIDED|95.0|-71.31|-24.85|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-24.85|-71.31|= 0.0001
73918252|NCT01979016|147364668|SUPERIORITY||LS Mean Difference|-21.5|||<|0.0001|TWO_SIDED|95.0|-29.0|-14.0|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-14.0|-29.0|<0.0001
73918253|NCT01979016|147364669|SUPERIORITY||LS Mean Difference|-31.3|||<|0.0001|TWO_SIDED|95.0|-41.5|-21.1|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-21.1|-41.5|< 0.0001
73918254|NCT01979016|147364670|SUPERIORITY||LS Mean Difference|-46.6|||<|0.0001|TWO_SIDED|95.0|-62.0|-31.3|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by MMRM model.||-31.3|-62.0|< 0.0001
73918255|NCT01979016|147364671|SUPERIORITY||Percentage difference|55.6|||<|0.0001|TWO_SIDED|95.0|33.38|77.73|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in EASI score (EASI-50). Analysis was performed by a MMRM model.||77.73|33.38|< 0.0001
73918256|NCT01979016|147364671|SUPERIORITY||Percentage difference|51.9|||=|0.0001|TWO_SIDED|95.0|29.59|74.12|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in EASI score (EASI-75). Analysis was performed by a MMRM model.||74.12|29.59|= 0.0001
73918257|NCT01979016|147364671|SUPERIORITY||Percentage difference|33.3|||=|0.0011|TWO_SIDED|95.0|15.55|51.11|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in EASI score (EASI-90). Analysis was performed by a MMRM model.||51.11|15.55|= 0.0011
73918258|NCT01979016|147364672|SUPERIORITY||Percentage difference|48.1|||=|0.0002|TWO_SIDED|95.0|27.0|69.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in SCORAD Score (SCORAD-50). Analysis was performed by a MMRM model.||69.3|27.0|= 0.0002
73918259|NCT01979016|147364672|SUPERIORITY||Percentage difference|11.1|||=|0.0792|TWO_SIDED|95.0|-0.7|23.0|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in SCORAD Score (SCORAD-75). Analysis was performed by a MMRM model.||23.0|-0.7|= 0.0792
73918260|NCT01979016|147364672|SUPERIORITY||Percentage difference|7.4|||=|0.1573|TWO_SIDED|95.0|-2.5|17.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in SCORAD Score (SCORAD-90). Analysis was performed by a MMRM model.||17.3|-2.5|= 0.1573
73918261|NCT01979016|147364673|SUPERIORITY||LS Mean Difference|-10.4|||<|0.0001|TWO_SIDED|95.0|-14.3|-6.6|||ANCOVA|||Analysis was performed by a MMRM model.||-6.6|-14.3|< 0.0001
73918262|NCT01979016|147364674|SUPERIORITY||LS Mean Difference|-46.2|||<|0.0001|TWO_SIDED|95.0|-63.9|-28.5|||ANCOVA|||Analysis was performed by a MMRM model.||-28.5|-63.9|< 0.0001
73918263|NCT01979016|147364676|SUPERIORITY||LS Mean Difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.02|-2.39|||ANCOVA|||||-2.39|-5.02|< 0.0001
73918264|NCT02509156|147364710|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.57||0.746|TWO_SIDED|95.0|-4.52|6.11|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||6.11|-4.52|0.746
73918265|NCT02509156|147364711|SUPERIORITY||slope of time|1.53|STANDARD_ERROR_OF_MEAN|0.63||0.024|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.024
73918266|NCT02509156|147364712|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.94||0.328|TWO_SIDED|95.0|-2.68|1.26|||ANCOVA||Confidence intervals based on t-test|The change in global strain was compared using ANCOVA analyses adjusting for baseline values.||1.26|-2.68|0.328
73918267|NCT02509156|147364713|SUPERIORITY||slope of time|-0.26|STANDARD_ERROR_OF_MEAN|0.23||0.261|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.261
73918268|NCT02509156|147364714|SUPERIORITY||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|1.41||0.071|TWO_SIDED|95.0|-4.51|1.35|||ANCOVA||Confidence intervals based on t-test|The change in regional strain was compared using ANCOVA analyses adjusting for baseline values.||1.35|-4.51|0.071
73918269|NCT02509156|147364715|SUPERIORITY||slope of time|-0.14|STANDARD_ERROR_OF_MEAN|0.35||0.689|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.689
73918270|NCT02509156|147364716|SUPERIORITY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|6.46||0.935|TWO_SIDED|95.0|-12.33|14.45|||ANCOVA||Confidence intervals based on t-test|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.||14.45|-12.33|0.935
73918271|NCT02509156|147364717|SUPERIORITY||slope of time|-1.56|STANDARD_ERROR_OF_MEAN|1.55||0.325|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.325
73918272|NCT02509156|147364718|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|5.99||0.919|TWO_SIDED|95.0|-11.75|13.08|||ANCOVA||Confidence intervals based on t-test|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.||13.08|-11.75|0.919
73918273|NCT02509156|147364719|SUPERIORITY||slope of time|-1.99|STANDARD_ERROR_OF_MEAN|1.45||0.183|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.183
73918274|NCT02509156|147364720|SUPERIORITY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.035||0.124|TWO_SIDED|95.0|0.003|0.15|||ANCOVA||Confidence intervals based on t-test|The change in LV sphericity index was compared using ANCOVA analyses adjusting for baseline values.||0.15|0.003|0.124
73918275|NCT02509156|147364721|SUPERIORITY|||||||||||||||||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. A time by treatment interaction was assessed.|There was a significant treatment and time interaction (p=0.024), so we report a slope for each treatment arm.|||
73918276|NCT02509156|147364722|SUPERIORITY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.14||0.993|TWO_SIDED|95.0|-3.05|1.74|||ANCOVA||Confidence intervals based on t-test|The change in scar percent was compared using ANCOVA analyses adjusting for baseline values.||1.74|-3.05|0.993
73918277|NCT02509156|147364723|SUPERIORITY||slope of time|-0.44|STANDARD_ERROR_OF_MEAN|0.29||0.151|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.151
73918278|NCT02509156|147364724|SUPERIORITY||Mean Difference (Final Values)|38.03|STANDARD_ERROR_OF_MEAN|20.96||0.056|TWO_SIDED|95.0|-5.84|81.89|||ANCOVA||Confidence intervals based on t-test|The change in distance walked was compared using ANCOVA analyses adjusting for baseline values.||81.89|-5.84|0.056
74086503|NCT02093923|147726524|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
73918279|NCT02509156|147364725|SUPERIORITY||slope of time|2.82|STANDARD_ERROR_OF_MEAN|5.06||0.583|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.583
73918280|NCT02509156|147364726|SUPERIORITY||Mean Difference (Final Values)|-12.82|STANDARD_ERROR_OF_MEAN|8.37||0.048|TWO_SIDED|95.0|-30.49|4.84|||ANCOVA||Confidence intervals based on t-test|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.||4.84|-30.49|0.048
73918281|NCT02509156|147364727|SUPERIORITY||slope of time|-8.07|STANDARD_ERROR_OF_MEAN|1.86||0.0002|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.0002
73918282|NCT02509156|147364728|SUPERIORITY||Mean Difference (Final Values)|-315.8|STANDARD_ERROR_OF_MEAN|295.0||0.199|TWO_SIDED|95.0|-947.5|315.8|||ANCOVA||Confidence intervals based on t-test|The change in NT-proBNP was compared using ANCOVA analyses adjusting for baseline values. Data log transformed. p-values were obtained from transformed data.||315.80|-947.50|0.199
73918283|NCT02509156|147364729|SUPERIORITY||slope of time|-23.391|STANDARD_ERROR_OF_MEAN|202.08||0.229|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported. Log transformation used for the regression. p-values were obtained from transformed data.||||0.229
73918284|NCT00555321|147364770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.9|||||TWO_SIDED|95.0|16.1|49.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||49.8|16.1|
73918285|NCT00555321|147364770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.6|||||TWO_SIDED|95.0|9.6|43.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||43.5|9.6|
73918286|NCT00555321|147364770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.8|||||TWO_SIDED|95.0|14.8|48.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||48.5|14.8|
73966778|NCT02814838|147470447|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.048||||0.2225|TWO_SIDED|95.0|-0.1257|0.0298|||Mixed Models Analysis|||at week 13||0.0298|-0.1257|0.2225
73966779|NCT02814838|147470447|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.0369||||0.551|TWO_SIDED|95.0|-0.1596|0.0858|||Mixed Models Analysis|||at week 26||0.0858|-0.1596|0.551
73966780|NCT02814838|147470447|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.063||||0.2501|TWO_SIDED|95.0|-0.1712|0.0453|||Mixed Models Analysis|||at week 52||0.0453|-0.1712|0.2501
73966781|NCT02814838|147470448|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.1494||||0.6252|TWO_SIDED|95.0|-0.7514|0.4526|||Mixed Models Analysis|||at FU week 13||0.4526|-0.7514|0.6252
73966782|NCT02814838|147470448|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.2804||||0.366|TWO_SIDED|95.0|-0.8904|0.3297|||Mixed Models Analysis|||At FU week 26||0.3297|-0.8904|0.366
73966783|NCT02814838|147470448|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.2063||||0.5026|TWO_SIDED|95.0|-0.3992|0.8118|||Mixed Models Analysis|||At FU week 52||0.8118|-0.3992|0.5026
73966784|NCT02814838|147470449|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|0.0242||||0.2527|TWO_SIDED|95.0|-0.0174|0.0658|||Mixed Models Analysis|||at week 13||0.0658|-0.0174|0.2527
74086504|NCT02093923|147726524|SUPERIORITY||Percent Change in Mean Rate|-84.08|||<|0.0001|TWO_SIDED|95.0|-93.07|-63.46|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-63.46|-93.07|<.0001
73966785|NCT02814838|147470449|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|0.0236||||0.2743|TWO_SIDED|95.0|-0.0188|0.066|||Mixed Models Analysis|||at week 26||0.066|-0.0188|0.2743
73966786|NCT02814838|147470449|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.0059||||0.7856|TWO_SIDED|95.0|-0.0485|0.0367|||Mixed Models Analysis|||at week 52||0.0367|-0.0485|0.7856
73918287|NCT00555321|147364770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||||TWO_SIDED|95.0|-8.7|29.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||29.6|-8.7|
73918288|NCT00555321|147364770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-15.3|23.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||23.2|-15.3|
73918289|NCT00555321|147364770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-9.8|28.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||28.4|-9.8|
73918290|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||8.7|-12.9|
73918291|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-13.6|8.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||8.5|-13.6|
73918292|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|||||TWO_SIDED|95.0|-23.8|1.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||1.5|-23.8|
73918293|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||||
73918294|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-12.1|11.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||11.3|-12.1|
73918295|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||||TWO_SIDED|95.0|-22.9|4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.1|-22.9|
73918296|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||8.7|-12.9|
73918297|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|||||TWO_SIDED|95.0|-18.1|5.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.4|-18.1|
73918298|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.1|||||TWO_SIDED|95.0|-38.9|-9.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-9.5|-38.9|
73966787|NCT02814838|147470450|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.0253||||0.9307|TWO_SIDED|95.0|-0.5986|0.548|||Mixed Models Analysis|||at week 13||0.548|-0.5986|0.9307
73966788|NCT02814838|147470450|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.7236||||0.0139|TWO_SIDED|95.0|-1.2989|-0.1483|||Mixed Models Analysis|||At week 26||-0.1483|-1.2989|0.0139
73966789|NCT02814838|147470450|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.5979||||0.0432|TWO_SIDED|95.0|-1.1775|-0.0184|||Mixed Models Analysis|||at week 52||-0.0184|-1.1775|0.0432
74027759|NCT01272180|147608892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|15.0|||||TWO_SIDED|95.0|0.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.||30|0|
73918299|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-9.9|14.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||14.4|-9.9|
73966790|NCT02814838|147470452|SUPERIORITY|||||||0.1171|||||||Fisher Exact|||at week 13||||0.1171
73966791|NCT02814838|147470452|SUPERIORITY|||||||0.6586|||||||Fisher Exact|||At week 26||||0.6586
73918300|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||||TWO_SIDED|95.0|-15.5|10.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||10.7|-15.5|
73918301|NCT00555321|147364771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|||||TWO_SIDED|95.0|-35.5|-4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-4.1|-35.5|
73966792|NCT02814838|147470452|SUPERIORITY|||||||0.5056|||||||Fisher Exact|||At week 52||||0.5056
73966793|NCT02814838|147470453|SUPERIORITY|||||||0.0779|||||||Fisher Exact|||at week 13||||0.0779
73966794|NCT02814838|147470453|SUPERIORITY|||||||0.0248|||||||Fisher Exact|||At week 26||||0.0248
73918302|NCT00555321|147364772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-14.5|15.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||15.3|-14.5|
73918303|NCT00555321|147364772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||||TWO_SIDED|95.0|-25.7|8.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||8.8|-25.7|
73918304|NCT00555321|147364772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-13.2|17.5|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||17.5|-13.2|
73918305|NCT00555321|147364772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-18.1|13.1|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||13.1|-18.1|
73918306|NCT00555321|147364772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|||||TWO_SIDED|95.0|-29.4|6.2|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||6.2|-29.4|
73918307|NCT00555321|147364772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-16.9|15.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||15.3|-16.9|
74086505|NCT02093923|147726524|SUPERIORITY||Percent Change in Mean Rate|-87.84|||<|0.0001|TWO_SIDED|95.0|-94.81|-71.5|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-71.50|-94.81|<.0001
73918308|NCT00555321|147364773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.1|||||TWO_SIDED|95.0|15.8|50.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||50.6|15.8|
73918309|NCT00555321|147364773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.0|||||TWO_SIDED|95.0|11.4|46.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||46.3|11.4|
73918310|NCT00555321|147364773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.2|||||TWO_SIDED|95.0|16.9|51.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||51.5|16.9|
73918311|NCT00555321|147364773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|||||TWO_SIDED|95.0|-7.1|31.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||31.6|-7.1|
73918312|NCT00555321|147364773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||||TWO_SIDED|95.0|-11.5|27.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||27.2|-11.5|
73918313|NCT00555321|147364773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.1|||||TWO_SIDED|95.0|-5.9|32.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||32.6|-5.9|
73918314|NCT00555321|147364774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|||||TWO_SIDED|95.0|-5.8|36.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||36.8|-5.8|
73918315|NCT00555321|147364774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|-6.0|38.0|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||38.0|-6.0|
73918316|NCT00555321|147364774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||||TWO_SIDED|95.0|-16.6|26.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||26.8|-16.6|
73918317|NCT00555321|147364774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||||TWO_SIDED|95.0|-10.8|36.1|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||36.1|-10.8|
73918318|NCT00555321|147364774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|||||TWO_SIDED|95.0|-10.9|37.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||37.3|-10.9|
73918319|NCT00555321|147364774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-21.8|26.0|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||26.0|-21.8|
73918320|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.1|||||TWO_SIDED|95.0|-6.7|43.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||43.3|-6.7|
73918321|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-21.6|25.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||25.5|-21.6|
73918322|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-20.1|28.7|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||28.7|-20.1|
73918323|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-21.2|32.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||32.1|-21.2|
73918324|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||||TWO_SIDED|95.0|-36.0|14.2|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||14.2|-36.0|
74086506|NCT02093923|147726525|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
73918325|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||||TWO_SIDED|95.0|-34.6|17.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||17.3|-34.6|
73918326|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-18.8|35.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||35.1|-18.8|
73918327|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|||||TWO_SIDED|95.0|-46.3|6.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||6.3|-46.3|
73918328|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4|||||TWO_SIDED|95.0|-48.2|5.2|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.2|-48.2|
73918329|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4|||||TWO_SIDED|95.0|-5.2|48.4|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||48.4|-5.2|
73918330|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|||||TWO_SIDED|95.0|-32.9|19.8|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||19.8|-32.9|
73918331|NCT00555321|147364798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9|||||TWO_SIDED|95.0|-34.8|18.7|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||18.7|-34.8|
73918332|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||||TWO_SIDED|95.0|-42.4|26.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||26.3|-42.4|
73918333|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||||TWO_SIDED|95.0|-49.2|19.0|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||19.0|-49.2|
73918334|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.8|||||TWO_SIDED|95.0|-81.6|-19.8|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||-19.8|-81.6|
73918335|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|||||TWO_SIDED|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||16.9|-55.9|
73918336|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1|||||TWO_SIDED|95.0|-62.6|9.4|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||9.4|-62.6|
73918337|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.7|||||TWO_SIDED|95.0|-94.0|-33.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||-33.1|-94.0|
73918338|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-32.6|34.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||34.3|-32.6|
73918339|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|||||TWO_SIDED|95.0|-47.4|20.6|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||20.6|-47.4|
73918340|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.5|||||TWO_SIDED|95.0|-72.6|0.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||0.5|-72.6|
73918341|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||||TWO_SIDED|95.0|-41.1|31.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||31.1|-41.1|
73918342|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|||||TWO_SIDED|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||16.9|-55.9|
73918343|NCT00555321|147364799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.5|||||TWO_SIDED|95.0|-81.9|-3.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||-3.5|-81.9|
73918344|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-21.2|6.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||6.0|-21.2|
73918345|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||5.3|-18.2|
73918346|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.5|-14.9|
73918347|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-25.1|7.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||7.1|-25.1|
73918348|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.5|-15.6|
73966795|NCT02814838|147470453|SUPERIORITY|||||||0.4504|||||||Fisher Exact|||At week 52||||0.4504
73918349|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||3.9|-12.7|
73918350|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||||
73918351|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.3|-18.2|
73918352|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||4.5|-14.9|
73918353|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||||
73918354|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||4.5|-15.6|
73918355|NCT00555321|147364812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||3.9|-12.7|
73918356|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-25.6|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.2|-25.6|
73918357|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|-11.7|22.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||22.3|-11.7|
73966796|NCT02814838|147470454|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.1402||||0.4163|TWO_SIDED|95.0|-0.2015|0.4819|||Mixed Models Analysis|||At week 13||0.4819|-0.2015|0.4163
73966797|NCT02814838|147470454|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.177||||0.3575|TWO_SIDED|95.0|-0.2039|0.558|||Mixed Models Analysis|||At week 26||0.558|-0.2039|0.3575
74027760|NCT01272180|147608892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|18.0|||||TWO_SIDED|95.0|5.0|31.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses MenABCWY combination vaccine to that of one dose of MenACWY vaccine.||31|5|
73918358|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-20.1|15.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||15.2|-20.1|
73918359|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-24.0|12.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||12.5|-24.0|
73918360|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-10.5|24.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||24.2|-10.5|
73966798|NCT02814838|147470454|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.0451||||0.8386|TWO_SIDED|95.0|-0.3948|0.4851|||Mixed Models Analysis|||At week 52||0.4851|-0.3948|0.8386
74027761|NCT01272180|147608892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|18.0|||||TWO_SIDED|95.0|7.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||30|7|
74027762|NCT01272180|147608892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|30.0|||||TWO_SIDED|95.0|18.0|42.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||42|18|
73918361|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-18.5|17.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||17.6|-18.5|
73918362|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-23.3|9.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||9.4|-23.3|
73918363|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.5|||||TWO_SIDED|95.0|-27.4|6.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||6.5|-27.4|
73918364|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|||||TWO_SIDED|95.0|-37.5|-2.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-2.7|-37.5|
73918365|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-15.5|19.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||19.7|-15.5|
73918366|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-19.4|16.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||16.9|-19.4|
73918367|NCT00555321|147364813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||||TWO_SIDED|95.0|-29.3|7.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||7.9|-29.3|
73918368|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|-6.3|36.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||36.0|-6.3|
73918369|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4|||||TWO_SIDED|95.0|-23.4|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.2|-23.4|
73918370|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-23.4|10.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.0|-23.4|
73918371|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-22.0|23.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||23.4|-22.0|
73918372|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|||||TWO_SIDED|95.0|-38.6|-0.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||-0.1|-38.6|
73918373|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|||||TWO_SIDED|95.0|-39.1|-1.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||-1.8|-39.1|
73918374|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.8|||||TWO_SIDED|95.0|-8.7|34.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||34.0|-8.7|
73918375|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-25.2|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||8.7|-25.2|
74086507|NCT02093923|147726525|SUPERIORITY||Percent Change in Mean Rate|-82.38|||<|0.0001|TWO_SIDED|95.0|-92.5|-58.64|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-58.64|-92.50|<.0001
73918376|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8|||||TWO_SIDED|95.0|-26.3|7.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||7.7|-26.3|
73918377|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-24.5|21.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12.||21.1|-24.5|
73918378|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|||||TWO_SIDED|95.0|-40.5|-1.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-1.9|-40.5|
73918379|NCT00555321|147364820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|||||TWO_SIDED|95.0|-41.8|-4.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-4.3|-41.8|
73918380|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.62|||||TWO_SIDED|90.0|-1.2|2.44||||||Comparison at 0.5 hours postdose.||2.44|-1.20|
73918381|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.89|||||TWO_SIDED|90.0|1.05|4.73||||||Comparison at 2.0 hours postdose.||4.73|1.05|
73918382|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.11|||||TWO_SIDED|90.0|0.28|3.95||||||Comparison at 3.0 hours postdose.||3.95|0.28|
73918383|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.48|||||TWO_SIDED|90.0|-0.36|3.32||||||Comparison at 4.0 hours postdose.||3.32|-0.36|
74027763|NCT01272180|147608892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|19.0|||||TWO_SIDED|95.0|4.0|33.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||33|4|
74086508|NCT02093923|147726525|SUPERIORITY||Percent Change in Mean Rate|-87.02|||<|0.0001|TWO_SIDED|95.0|-94.55|-69.06|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-69.06|-94.55|<.0001
73918384|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.48|||||TWO_SIDED|90.0|-0.36|3.32||||||Comparison at 5.0 hours postdose.||3.32|-0.36|
73918385|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.48|||||TWO_SIDED|90.0|1.64|5.32||||||Comparison at 6.0 hours postdose.||5.32|1.64|
73918386|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.12|||||TWO_SIDED|90.0|0.27|3.97||||||Comparison at 8.0 hours postdose.||3.97|0.27|
73918387|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.67|||||TWO_SIDED|90.0|-0.17|3.51||||||Comparison at 12.0 hours postdose.||3.51|-0.17|
73918388|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.01|||||TWO_SIDED|90.0|-1.57|3.59||||||Comparison at 0.5 hours postdose.||3.59|-1.57|
73918389|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.99|||||TWO_SIDED|90.0|2.4|7.57||||||Comparison at 2.0 hours postdose.||7.57|2.40|
73918390|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.28|||||TWO_SIDED|90.0|3.71|8.86||||||Comparison at 3.0 hours postdose.||8.86|3.71|
73918391|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.35|||||TWO_SIDED|90.0|3.78|8.93||||||Comparison at 4.0 hours postdose.||8.93|3.78|
73918392|NCT01606436|147364851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.71|||||TWO_SIDED|90.0|2.11|7.31||||||Comparison at 12.0 hours postdose.||7.31|2.11|
74027764|NCT01272180|147608892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days.|Group Difference % (ABCWY+qOMV - ACWY)|15.0|||||TWO_SIDED|95.0|3.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||29|3|
73918393|NCT02268084|147364869|SUPERIORITY|||||||0.007|||||||ANOVA|||Null hypothesis is that the active treatment group does not differ from the sham group in changes in the PCL-M total scores.||||.007
73918394|NCT02268084|147364870|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||.326
73918395|NCT03334448|147364904|SUPERIORITY||Ratio of Geometric Least Square Means|0.83|||||TWO_SIDED|90.0|0.818|0.957||||||||0.957|0.818|
73918396|NCT03334448|147364905|SUPERIORITY||Ration of Lease Square Means|0.97|||||TWO_SIDED|90.0|0.83|1.09||||||||1.09|0.83|
73918397|NCT01683383|147364910|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Adjusted Wald estimation|||||||<0.001
73918398|NCT01683383|147364911|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
73918399|NCT01683383|147364913|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73918400|NCT00996307|147364920|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided confidence intervals (CIs) were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.06|||||TWO_SIDED|95.0|2.55|6.46|||||Ratio of GMTs at Day 22|||6.46|2.55|
73918401|NCT00996307|147364920|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.25|||||TWO_SIDED|95.0|1.42|3.56|||||Ratio of GMTs at Day 22|||3.56|1.42|
73918402|NCT00996307|147364920|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.49|||||TWO_SIDED|95.0|2.8|7.19|||||Ratio of GMTs at Day 22|||7.19|2.8|
73918403|NCT00996307|147364920|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.49|||||TWO_SIDED|95.0|1.56|3.96|||||Ratio of GMTs at Day 22|||3.96|1.56|
73918404|NCT00996307|147364920|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|8.01|||||TWO_SIDED|95.0|5.52|12.0|||||Ratio of GMTs at Day 43|||12|5.52|
73918405|NCT00996307|147364920|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.25|||||TWO_SIDED|95.0|2.94|6.15|||||Ratio of GMTs at Day 43|||6.15|2.94|
74086509|NCT02093923|147726526|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
74086510|NCT02093923|147726526|SUPERIORITY||Percent Change in Mean Rate|-85.24||||0.0141||95.0|-96.79|-32.03|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-32.03|-96.79|0.0141
74086511|NCT02093923|147726526|SUPERIORITY||Percent Change in Mean Rate|-89.35||||0.004|TWO_SIDED|95.0|-97.68|-51.13|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-51.13|-97.68|0.0040
74086512|NCT00248170|147726527|SUPERIORITY_OR_OTHER|||||||0.315|||||||Log Rank|||||||0.3150
73918406|NCT00996307|147364920|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|7.81|||||TWO_SIDED|95.0|5.36|11.0|||||Ratio of GMTs at Day 43|||11|5.36|
73918407|NCT00996307|147364920|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratios of GMTs|4.15|||||TWO_SIDED|95.0|2.86|6.02|||||Ratio of GMTs at Day 43|||6.02|2.86|
73918408|NCT00996307|147364920|SUPERIORITY_OR_OTHER||Ratio of GMTs|3.66|||||TWO_SIDED|95.0|2.37|5.65||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22||5.65|2.37|
73918409|NCT00996307|147364920|SUPERIORITY_OR_OTHER||Ratio of GMTs|2.21|||||TWO_SIDED|95.0|1.43|3.4||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||3.4|1.43|
73918410|NCT00996307|147364920|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.42|||||TWO_SIDED|95.0|2.85|6.86||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||6.86|2.85|
73918411|NCT00996307|147364920|SUPERIORITY_OR_OTHER||Ratio of GMTs|2.67|||||TWO_SIDED|95.0|1.72|4.13||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||4.13|1.72|
73918412|NCT00996307|147364920|SUPERIORITY_OR_OTHER||Ratio of GMTs|7.82|||||TWO_SIDED|95.0|5.54|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||11|5.54|
73918413|NCT00996307|147364920|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.55|||||TWO_SIDED|95.0|3.23|6.42||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines||6.42|3.23|
73918414|NCT00996307|147364920|SUPERIORITY_OR_OTHER||Ratio of GMTs|7.52|||||TWO_SIDED|95.0|5.3|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||11|5.3|
73918415|NCT00996307|147364920|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.37|||||TWO_SIDED|95.0|3.09|6.19||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||6.19|3.09|
73918416|NCT01767155|147364932|OTHER||Kaplan-Meier|69.8|||||TWO_SIDED|95.0|63.6|75.1||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||75.1|63.6|
73918417|NCT01767155|147364932|OTHER||Kaplan-Meier|45.8|||||TWO_SIDED|95.0|39.5|52.0||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||52.0|39.5|
73918418|NCT01767155|147364932|OTHER||Kaplan-Meier|72.1|||||TWO_SIDED|95.0|66.0|77.3||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||77.3|66.0|
73918419|NCT01767155|147364932|OTHER||Kaplan-Meier|44.6|||||TWO_SIDED|95.0|38.2|50.7||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||50.7|38.2|
73918420|NCT01767155|147364932|OTHER||Hazard Ratio (HR)|1.06||||0.5441|TWO_SIDED|95.0|0.87|1.3|||Log Rank|2-sided||A Cox model with treatment effects was used to estimate the hazard ratio and perform hypothesis testing. The estimated hazard ratio and the 95% CI of the hazard ratio were presented.||1.30|0.87|0.5441
73918421|NCT01767155|147364933|OTHER||Odds Ratio (OR)|0.87||||0.5907|TWO_SIDED|95.0|0.52|1.45|||Mantel Haenszel|2-sided test||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test. The odds ratio and 95% CI of the odds ratio were presented.||1.45|0.52|0.5907
73918422|NCT01767155|147364934|OTHER||Kaplan-Meier|46.7|||||TWO_SIDED|95.0|39.5|53.6||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months.||53.6|39.5|
73918423|NCT01767155|147364934|OTHER||Kaplan-Meier|20.6|||||TWO_SIDED|95.0|14.6|27.4||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||27.4|14.6|
73918424|NCT01767155|147364934|OTHER||Kaplan-Meier|47.5|||||TWO_SIDED|95.0|40.0|54.7||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||54.7|40.0|
73918425|NCT01767155|147364934|OTHER||Kaplan-Meier|12.3|||||TWO_SIDED|95.0|6.9|19.3||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||19.3|6.9|
73918426|NCT01767155|147364934|OTHER||Hazard Ratio (HR)|0.89||||0.3089|TWO_SIDED|95.0|0.71|1.11|||Log Rank|2-sided||Hypothesis testing between the two treatment arms was performed using a log rank test.||1.11|0.71|0.3089
73918427|NCT01767155|147364935|OTHER||Odds Ratio (OR)|1.07||||0.6924|TWO_SIDED|95.0|0.76|1.52|||Mantel Haenszel|2-sided||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test.||1.52|0.76|0.6924
73918428|NCT00371137|147364945|SUPERIORITY_OR_OTHER||||||>|0.001||95.0|||||Chi-squared|||Overall Comparison||||>0.001
73918429|NCT00371137|147364945|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||Pairwise comparison of placebo and Xyrem 4.5g||||<0.001
73918430|NCT00371137|147364945|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||Pairwise comparison of placebo and Xyrem 6.0g||||0.015
73918431|NCT00536198|147364946|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Group comparison||||0.21
73918432|NCT00536198|147364946|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
73966799|NCT02814838|147470455|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.354|||=|0.1114|TWO_SIDED|95.0|-0.09|0.75|||t-test, 2 sided|||At week 13||0.75|-0.09|= 0.1114
73918433|NCT00536198|147364946|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||ANOVA|||Group by time: comparison of rates of change||||0.06
73918434|NCT00536198|147364946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.88|STANDARD_ERROR_OF_MEAN|0.95||0.049|TWO_SIDED|95.0|0.01|3.75|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo||3.75|0.01|0.049
73918435|NCT00536198|147364947|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||ANOVA|||Group comparison||||0.54
73918436|NCT00536198|147364947|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
73918437|NCT00536198|147364947|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||Group by time: comparison of rates of change||||0.02
73918438|NCT00536198|147364947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.14|STANDARD_ERROR_OF_MEAN|1.62||0.0015|TWO_SIDED|95.0|1.97|8.31|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||8.31|1.97|0.0015
73918439|NCT00536198|147364948|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||ANOVA|||Group comparison||||0.46
74086513|NCT01631682|147726541|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after propranolol was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||>.05
73918440|NCT00536198|147364948|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.0001
73918441|NCT00536198|147364948|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.69
73918442|NCT00536198|147364948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02||||0.84|TWO_SIDED|95.0|0.83|1.26|||Mixed Models Analysis|||Estimated mean difference from Cycle 1 to end point between active vs. placebo||1.26|0.83|0.84
73918443|NCT00536198|147364949|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Group comparison||||0.01
73918444|NCT00536198|147364949|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Change over time in both groups||||<0.001
73918445|NCT00536198|147364949|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Chi-squared|||Group by time: comparison rates of change||||0.28
73918446|NCT00536198|147364949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59||||0.056|TWO_SIDED|95.0|0.3|1.19|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.19|0.30|0.056
73918447|NCT00536198|147364951|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||Group comparison||||0.30
73918448|NCT00536198|147364951|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.01
73918449|NCT00536198|147364951|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.73
73918450|NCT00536198|147364951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.12||||0.06|TWO_SIDED|95.0|0.92|1.35|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.35|0.92|0.06
73918451|NCT00536198|147364952|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||ANOVA|||Group comparison||||0.80
73918452|NCT00536198|147364952|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
73918453|NCT00536198|147364952|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.43
73918454|NCT00536198|147364952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.11||||0.61|TWO_SIDED|95.0|0.85|1.45|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo||1.45|0.85|0.61
73918455|NCT00536198|147364953|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||ANOVA|||Group comparison||||0.83
73918456|NCT00536198|147364953|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
73918457|NCT00536198|147364953|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.02
73918458|NCT00536198|147364953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.169|TWO_SIDED|95.0|0.96|1.25|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.25|0.96|0.169
73966800|NCT02814838|147470455|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.502|||=|0.0411|TWO_SIDED|95.0|0.02|0.98|||t-test, 2 sided|||At week 26||0.98|0.02|= 0.0411
73966801|NCT02814838|147470455|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.223|||=|0.4506|TWO_SIDED|95.0|-0.37|0.82|||t-test, 2 sided|||At week 52||0.82|-0.37|= 0.4506
73966802|NCT02814838|147470456|SUPERIORITY||Adjusted mean difference|0.3631||||0.1847|TWO_SIDED|95.0|-0.1817|0.908|||Mixed Models Analysis|||Week 13 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||0.908|-0.1817|0.1847
73966803|NCT02814838|147470456|SUPERIORITY||Adjusted mean difference|0.6304||||0.031|TWO_SIDED|95.0|0.0609|1.1998|||Mixed Models Analysis|||Week 26 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||1.1998|0.0609|0.031
73966804|NCT02814838|147470456|SUPERIORITY||Adjusted mean difference|0.1639||||0.6299|TWO_SIDED|95.0|-0.5202|0.8479|||Mixed Models Analysis|||Week 52 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||0.8479|-0.5202|0.6299
73918459|NCT00536198|147364954|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||ANOVA|||Group comparison||||0.37
74086514|NCT01631682|147726541|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was initially presented (CS+R) and then followed by a series of extinction trials after a 10-min delay would result in a smaller SCR than a conditioned stimulus (CS+N) that was not extinguished without a 10-min delay.||||>.05
73918460|NCT00536198|147364954|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
73918461|NCT00536198|147364954|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.73
73918462|NCT00536198|147364954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.08||||0.13|TWO_SIDED|95.0|0.91|1.28|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.28|0.91|0.13
73918463|NCT00536198|147364955|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||ANOVA|||Group comparison||||0.31
73918464|NCT00536198|147364955|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
73918465|NCT00536198|147364955|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.46
73918466|NCT00536198|147364955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.94|TWO_SIDED|95.0|0.96|1.23|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.23|0.96|0.94
73918467|NCT00536198|147364956|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Group comparison||||<0.001
73918468|NCT00536198|147364956|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
74086515|NCT01631682|147726541|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after mifepristone was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||<.05
73918469|NCT00536198|147364956|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||<0.01
73918470|NCT00536198|147364956|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.22||||0.027|TWO_SIDED|95.0|1.05|1.41|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.41|1.05|0.027
73918471|NCT00536198|147364957|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Group comparison||||0.01
73918472|NCT00536198|147364957|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Group by time: comparison rates of change||||<0.001
73918473|NCT00536198|147364957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.056|TWO_SIDED|95.0|0.3|1.02|||Mixed Models Analysis|||Estimated mean difference between active and placebo groups at end-point only||1.02|0.30|0.056
73918474|NCT01691781|147364985|SUPERIORITY|||||||0.049||||||This p-value reflects the difference in PTH means among participants with primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.049
73918475|NCT01691781|147364985|SUPERIORITY|||||||0.8||||||This p-value reflects the difference in PTH means among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among normal control participants (without primary hyperparathyroidism).||||0.80
73918476|NCT01691781|147364986|SUPERIORITY|||||||0.22||||||This p-value reflects the comparison of means among the primary hyperparathyroidism group only.|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.22
73918477|NCT01691781|147364986|SUPERIORITY|||||||0.86||||||This p-value reflects the mean difference in 24h aldosterone excretion rate among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.||||0.86
73918478|NCT01691781|147364987|SUPERIORITY|||||||0.48||||||This p-value reflects the statistic for the comparison of mean calcium levels for the primary hyperparathyroidism group.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.48
73918479|NCT01691781|147364987|SUPERIORITY|||||||0.8||||||This p-value reflects the statistic for the comparison of mean calcium levels for the normal control participants without primary hyperparathyroidism.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.||||0.80
73918480|NCT01897402|147365013|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.6|||||TWO_SIDED|95.0|-7.9|9.1|||||Serogroup A|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||9.1|-7.9|
73918481|NCT01897402|147365013|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-6.0|||||TWO_SIDED|95.0|-14.6|2.6|||||Serogroup C|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||2.6|-14.6|
73966805|NCT02814838|147470457|SUPERIORITY|||||||0.163|||||||Fisher Exact|||Week 13||||0.163
73966806|NCT02814838|147470457|SUPERIORITY|||||||0.0074|||||||Fisher Exact|||Week 26||||0.0074
73966807|NCT02814838|147470457|SUPERIORITY|||||||0.4437|||||||Fisher Exact|||Week 52||||0.4437
74086516|NCT01631682|147726541|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after intranasal oxytocin was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||>.05
73918482|NCT01897402|147365013|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-9.9|7.9|||||Serogroup Y|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||7.9|-9.9|
73918483|NCT01897402|147365013|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.3|||||TWO_SIDED|95.0|-8.5|9.1|||||Serogroup W-135|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||9.1|-8.5|
73918484|NCT01209260|147365027|SUPERIORITY_OR_OTHER|||||||0.005||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05|t-test, 2 sided|||Sample size of 72 was targeted to achieve 80% power to detect a 5-minute reduction in transseptal access procedure time (assuming a standard deviation of 7.5 minutes), using a 2-sided alpha of 0.05, with the primary analysis done on an intention-to-treat basis.||||0.005
73918485|NCT01209260|147365029|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05|Chi-squared|||||||<0.001
73918486|NCT01209260|147365030|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05.|Chi-squared|||||||<0.001
73918487|NCT04853225|147365114|OTHER||Adjusted rate of change|-59.46|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918488|NCT04853225|147365114|OTHER||Adjusted rate of change|-62.73|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918489|NCT04853225|147365114|OTHER||Adjusted rate of change|-48.54|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918490|NCT04853225|147365114|OTHER||Adjusted rate of change|-50.32|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918491|NCT04853225|147365114|OTHER||Adjusted rate of change|-22.67|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
74086517|NCT06442410|147726566|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73918492|NCT04853225|147365114|OTHER||Adjusted rate of change|-33.32|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918493|NCT04853225|147365114|OTHER||Adjusted rate of change|-20.4|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918494|NCT04853225|147365114|OTHER||Adjusted rate of change|-31.08|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
74086518|NCT06442410|147726567|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73918495|NCT04853225|147365114|OTHER||Adjusted rate of change|-64.74|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918496|NCT04853225|147365114|OTHER||Adjusted rate of change|-60.26|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918497|NCT04853225|147365114|OTHER||Adjusted rate of change|-27.85|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918498|NCT04853225|147365114|OTHER||Adjusted rate of change|-28.65|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918499|NCT04853225|147365115|OTHER||Adjusted rate of change|-87.47|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918500|NCT04853225|147365115|OTHER||Adjusted rate of change|-83.25|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918501|NCT04853225|147365115|OTHER||Adjusted rate of change|-77.54|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918502|NCT04853225|147365115|OTHER||Adjusted rate of change|-77.41|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918503|NCT04853225|147365115|OTHER||Adjusted rate of change|-60.1|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
74086519|NCT06442410|147726568|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74086520|NCT06442410|147726569|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74086521|NCT06442410|147726570|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74086522|NCT06442410|147726571|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73918504|NCT04853225|147365115|OTHER||Adjusted rate of change|-73.65|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918505|NCT04853225|147365115|OTHER||Adjusted rate of change|-45.44|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918506|NCT04853225|147365115|OTHER||Adjusted rate of change|-79.49|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918507|NCT04853225|147365115|OTHER||Adjusted rate of change|-74.39|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918508|NCT04853225|147365115|OTHER||Adjusted rate of change|-63.04|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918509|NCT04853225|147365115|OTHER||Adjusted rate of change|-25.59|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73918510|NCT04853225|147365115|OTHER||Adjusted rate of change|-38.69|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
73966808|NCT03811366|147470458|OTHER||||||<|0.001||||||significance when p\<0;05|generalized estimated equation|generalized estimated equation with normal distribution and logarithmic link function||||||<0.001
74086523|NCT06442410|147726573|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
74086524|NCT06442410|147726574|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
74086525|NCT06442410|147726575|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
74086526|NCT06442410|147726576|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
74086527|NCT06442410|147726577|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
74086528|NCT06442410|147726578|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
73918511|NCT03918447|147365116|SUPERIORITY||Least Square Means Difference|0.97|STANDARD_ERROR_OF_MEAN|1.122|=|0.3886|TWO_SIDED|95.0|-1.25|3.19|||ANCOVA|||ANCOVA model with baseline eGFR as a covariate, and treatment group as fixed effects.||3.19|-1.25|=0.3886
73918512|NCT03918447|147365118|SUPERIORITY||Least Square Means Difference|7.94|STANDARD_ERROR_OF_MEAN|0.777|<|0.0001|TWO_SIDED|95.0|6.41|9.47|||MMRM|||Mixed model repeated measure (MMRM) model used baseline eGFR as a covariate, and the following fixed factors: treatment group, time (Week 1 to 100, excluding Week 52), and the interaction between treatment and time. Within-participant errors are modeled using an unstructured covariance matrix.||9.47|6.41|<0.0001
73918513|NCT01405456|147365119|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change in Insulin Stimulated Glucose Uptake measured during euglycemic hyperinsulinemic clamp procedure from baseline to 6 months||||0.71
73918514|NCT01405456|147365120|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Change in Visceral Adipose Tissue area as measured by magnetic resonance imaging of the abdomen from baseline to 6 months||||0.42
73918515|NCT01405456|147365121|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in Liver Fat (Intrahepatic Lipid) as measured by magnetic resonance spectroscopy from baseline to 6 months||||0.51
73918516|NCT01405456|147365122|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in Intramyocellular Lipid of calf muscles as measured by magnetic resonance spectroscopy from baseline to 6 months||||0.04
73918517|NCT01405456|147365123|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change in Flow Mediated Vasodilation (maximum percentage) from baseline to 6 months||||0.44
73918518|NCT01405456|147365124|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Mean serum measurements of Potassium||||0.07
73918519|NCT01405456|147365125|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change in Hemoglobin A1c from baseline to 6 months||||0.70
73918520|NCT01405456|147365126|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in C-Reactive Protein from baseline to 6 months||||0.10
73918521|NCT01405456|147365127|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||Change in Plasminogen Activator Inhibitor 1 from baseline to 6 months||||0.37
73918522|NCT01405456|147365128|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change in Adiponectin from baseline to 6 months||||0.78
73918523|NCT01405456|147365129|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in IL-6 from baseline to 6 months||||0.10
73966809|NCT03811366|147470461|OTHER|||||||0.054||||||significance when p\<0.05|Fisher Exact|||Recurrence or worsening of cells in anterior chamber in ERG-stable and ERG worsening group.||||0.054
73966810|NCT03811366|147470462|OTHER|||||||0.478||||||17 eyes presented dark dots fluctuation during follow up in stable ERG group when compared to 5 eyes in worsening ERG group.|generalized estimated equation|Generalized estimated equation with Poisson distribution and identity link function supposing an interchangeable correlation matrix between the eyes||||||0.478
73966811|NCT03811366|147470464|OTHER|9 (52.9%) eyes in ERG stable group x 4 (57.1%)eyes presented change in perivascular leakage during follow up (p=0.936).||||||0.936|||||||Generalized estimated equation|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;||Change in perivascular leakage in ERG-stable and ERG- worsening groups.||||0.936
73966812|NCT03811366|147470465|OTHER|||||||0.853||||||significance when p\<0.05|Generalized estimated equation|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;||||||0.853
74086529|NCT06442410|147726579|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
73918524|NCT01405456|147365130|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Change in MCP-1 from baseline to 6 months||||0.04
73918525|NCT02557698|147365146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.002|TWO_SIDED|95.0|-3.1|-0.8|||t-test, 2 sided|||H0=Intervention and control groups do not differ with respect to the TEWL forearm at visit 3 H1=The TEWL on the forearm at visit 3 differs between the groups||-0.8|-3.1|0.002
73918526|NCT02557698|147365147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.5|-1.2|||t-test, 2 sided|||||-1.2|-3.5|<0.001
73918527|NCT02557698|147365148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.024|TWO_SIDED|95.0|-3.2|-0.2|||t-test, 2 sided|||||-0.2|-3.2|0.024
73918528|NCT02557698|147365149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.017|TWO_SIDED|95.0|-3.1|-0.3|||t-test, 2 sided|||||-0.3|-3.1|0.017
73918529|NCT02557698|147365150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.964|TWO_SIDED|95.0|-3.9|3.7|||t-test, 2 sided|||||3.7|-3.9|0.964
73918530|NCT02557698|147365151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.025|TWO_SIDED|95.0|0.5|8.2|||t-test, 2 sided|||||8.2|0.5|0.025
73918531|NCT02557698|147365152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.458|TWO_SIDED|95.0|-2.5|1.1|||t-test, 2 sided|||||1.1|-2.5|0.458
73918532|NCT02557698|147365153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.066|TWO_SIDED|95.0|-3.5|0.1|||t-test, 2 sided|||||0.1|-3.5|0.066
73918533|NCT02557698|147365154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.171|TWO_SIDED|95.0|-13.7|2.5|||t-test, 2 sided|||||2.5|-13.7|0.171
73918534|NCT02557698|147365155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.059|TWO_SIDED|95.0|-15.3|0.3|||t-test, 2 sided|||||0.3|-15.3|0.059
73918535|NCT02557698|147365156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.4|TWO_SIDED|95.0|-0.2|0.5|||t-test, 2 sided|||||0.5|-0.2|0.400
73918536|NCT02557698|147365157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.4|||t-test, 2 sided|||||0.4|-0.1|0.100
73918537|NCT02557698|147365158|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
73918538|NCT02557698|147365159|SUPERIORITY_OR_OTHER|||||||0.914|||||||Wilcoxon (Mann-Whitney)|||||||0.914
73918539|NCT02557698|147365160|SUPERIORITY_OR_OTHER|||||||0.822|||||||Wilcoxon (Mann-Whitney)|||||||0.822
73918540|NCT02557698|147365161|SUPERIORITY_OR_OTHER|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
73918541|NCT02557698|147365162|SUPERIORITY_OR_OTHER|||||||0.259|||||||Wilcoxon (Mann-Whitney)|||||||0.259
73918542|NCT02557698|147365163|SUPERIORITY_OR_OTHER|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||||||0.581
73918543|NCT02557698|147365164|SUPERIORITY_OR_OTHER|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
73918544|NCT02557698|147365165|SUPERIORITY_OR_OTHER|||||||0.759|||||||Wilcoxon (Mann-Whitney)|||||||0.759
73918545|NCT02557698|147365166|SUPERIORITY_OR_OTHER|||||||0.831|||||||Wilcoxon (Mann-Whitney)|||||||0.831
73918546|NCT02557698|147365167|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
73918547|NCT02557698|147365168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.07|TWO_SIDED|95.0|-0.3|7.4|||t-test, 2 sided|||||7.4|-0.3|0.07
73918548|NCT02557698|147365169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.029|TWO_SIDED|95.0|0.4|7.7|||t-test, 2 sided|||||7.7|0.4|0.029
73918549|NCT02557698|147365170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.325|TWO_SIDED|95.0|-1.8|0.6|||t-test, 2 sided|||||0.6|-1.8|0.325
73918550|NCT02557698|147365171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.365|TWO_SIDED|95.0|-2.6|0.9|||t-test, 2 sided|||||0.9|-2.6|0.365
73918551|NCT02557698|147365172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.143|TWO_SIDED|95.0|-8.5|1.3|||t-test, 2 sided|||||1.3|-8.5|0.143
73918552|NCT02557698|147365173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.662|TWO_SIDED|95.0|-6.5|4.2|||t-test, 2 sided|||||4.2|-6.5|0.662
73918553|NCT02557698|147365174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.326|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided|||||0.1|-0.4|0.326
73918554|NCT02557698|147365175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.687|TWO_SIDED|95.0|-0.2|0.4|||t-test, 2 sided|||||0.4|-0.2|0.687
73918555|NCT02289690|147365176|OTHER||RP2D for veliparib in mg BID for 14 days|240.0|||||TWO_SIDED||||||||The RP2D for veliparib was determined to be 240 mg BID for 14 days with carboplatin (AUC 5 mg/mL\*min) on Day 1 and etoposide (100 mg/m²) on Days 1 to 3 during 21-day cycles for 4 cycles.|A primary objective of Phase 1 was to establish the recommended phase 2 dose (RP2D) for veliparib combined with carboplatin and etoposide. The RP2D was determined by the rate of DLTs and overall tolerability of veliparib plus carboplatin and etoposide.||||
73918556|NCT02289690|147365192|SUPERIORITY||Hazard Ratio (HR)|0.665||||0.059|TWO_SIDED|80.0|0.503|0.88|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio \< 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"The primary efficacy analysis in the Phase 2 portion of the study was the comparison of PFS among participants who received veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A) vs. placebo in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm C).~Statistical significance was determined by a two-sided p-value ≤ 0.2"||0.880|0.503|0.059
73918557|NCT02289690|147365192|SUPERIORITY||Hazard Ratio (HR)|0.979||||0.924|TWO_SIDED|80.0|0.744|1.288|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.288|0.744|0.924
73966813|NCT03811366|147470466|OTHER|||||||0.272||||||significance when p\<0.05|Fisher Exact|||||||0.272
73966814|NCT03811366|147470467|OTHER|||||||0.983||||||significance when p\<0.05|Generalized estimated equation with bino|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes||||||0.983
73918558|NCT02289690|147365193|SUPERIORITY||Hazard Ratio (HR)|1.432||||0.088|TWO_SIDED|80.0|1.092|1.879|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.879|1.092|0.088
74086530|NCT04947150|147726580|SUPERIORITY|||||||0.255||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA were used.||||||.255
73918559|NCT02289690|147365193|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.083|TWO_SIDED|80.0|1.104|1.931|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.931|1.104|0.083
73918560|NCT02289690|147365194|SUPERIORITY||Odds Ratio (OR)|1.9||||0.115|TWO_SIDED|80.0|1.1|3.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of \> 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||3.2|1.1|0.115
73918561|NCT02289690|147365194|SUPERIORITY||Odds Ratio (OR)|0.8||||0.604|TWO_SIDED|80.0|0.5|1.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of \> 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.3|0.5|0.604
73918562|NCT01391559|147365212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0||||0.17||95.0|||||t-test, 2 sided|||||||0.17
73918563|NCT00267046|147365213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fine and Gray method.|||||||<0.001
73918564|NCT01111149|147365276|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Cotinine at Week 12||||>0.05
73918565|NCT01111149|147365276|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Nicotine at Week 12||||>0.05
73918566|NCT01111149|147365276|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Cotinine at Week 12||||>0.05
73918567|NCT01111149|147365276|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Nicotine at Week 12||||>0.05
73918568|NCT01111149|147365277|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical analysis for 50% Reduction in Number of Cigarettes Smoked (Week 12)||||>0.05
73918569|NCT01111149|147365277|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Carbon Monoxide (Week 12)||||>0.05
73918570|NCT01111149|147365277|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Serum Cotinine (Week 12)||||>0.05
74027765|NCT01183858|147608903|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.671|TWO_SIDED|95.0|0.83|1.33||Unstratified analysis.|Log Rank|||||1.33|0.83|0.671
73918571|NCT01111149|147365277|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Urine Cotinine (Week 12)||||>0.05
73918572|NCT01111149|147365278|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Composite (Week 12)||||>0.05
73918573|NCT01111149|147365278|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Global (Week 12)||||>0.05
73918574|NCT01111149|147365278|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Affective Flattening (Week 12)||||>0.05
73918575|NCT01111149|147365278|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Alogia (Week 12)||||>0.05
73918576|NCT01111149|147365278|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Avolition (Week 12)||||>0.05
74086531|NCT04947150|147726581|SUPERIORITY|||||||0.56||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.560
73918577|NCT01111149|147365278|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Anhedonia (Week 12)||||>0.05
73918578|NCT01111149|147365278|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Attention (Week 12)||||>0.05
74027766|NCT01183858|147608909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.625|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||||1.33|0.84|0.625
74027767|NCT00641147|147608913|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
74027768|NCT00641147|147608913|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||0.57
74027769|NCT00641147|147608914|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
74027770|NCT00641147|147608915|SUPERIORITY|||||||0.85|||||||Chi-squared|||||||0.85
74086532|NCT04947150|147726582|SUPERIORITY|||||||0.319||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.319
74086533|NCT04947150|147726583|SUPERIORITY|||||||0.032||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.032
73918579|NCT01111149|147365278|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis of Inappropriate Affect at Week 12||||>0.05
73918580|NCT01111149|147365279|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT % Omissions (Week 12)||||>0.05
73918581|NCT01111149|147365279|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT% commissions (Week 12)||||>0.05
73918582|NCT01111149|147365279|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for perseveration % (week 12)||||>0.05
73918583|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Anxiety at week 12||||>0.05
73918584|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dizziness at week 12||||>0.05
73918585|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Mania at week 12||||>0.05
73918586|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for abnormal dreams at week 12||||>0.05
73918587|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Abdominal Pain at week 12||||>0.05
73918588|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Headache at week 12||||>0.05
73918589|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Insomnia at week 12||||>0.05
74027771|NCT00641147|147608916|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
74027772|NCT00641147|147608917|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
74086534|NCT04947150|147726584|SUPERIORITY|||||||0.044||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.044
73918590|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Nausea at week 12||||>0.05
73918591|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Psychosis at week 12||||>0.05
73918592|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dry Mouth at week 12||||>0.05
73918593|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Chest Pain at Week 12||||>0.05
73918594|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irregular Heart Beat at week 12||||>0.05
73918595|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Weakness/Fainting at week 12||||>0.05
73918596|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Diarrhea at week 12||||>0.05
73918597|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Vomiting at week 12||||>0.05
73918598|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Constipation at week 12||||>0.05
73918599|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Confusion at week 12||||>0.05
73918600|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irritability at week 12||||>0.05
73918601|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for drooling at week 12||||>0.05
73918602|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Cold Sweats at week 12||||>0.05
73918603|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Blurred Vision at week 12||||>0.05
73918604|NCT01111149|147365280|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Leg Pain/Cramps||||>0.05
73918605|NCT01111149|147365281|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for FTND (Week 12)||||>0.05
73918606|NCT01111149|147365281|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 24 Hour Total (Week 12)||||>0.05
73918607|NCT01111149|147365281|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 7 day total (Week 12)||||>0.05
73918608|NCT01111149|147365281|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS Resistance (Week 12)||||>0.05
74027773|NCT00641147|147608918|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
73918609|NCT01111149|147365282|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis of Beck Depression Inventory (Week 12)||||>0.05
73918610|NCT01111149|147365283|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAS (Week 12)||||>0.05
73918611|NCT01111149|147365283|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS items 1-3 (week 12)||||>0.05
73918612|NCT01111149|147365283|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS item 4 (Week 12)||||>0.05
73918613|NCT01111149|147365284|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for systolic blood pressure (Week 12)||||>0.05
73918614|NCT01111149|147365284|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for diastolic blood pressure (Week 12)||||>0.05
73918615|NCT01111149|147365285|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Weight (Week 12)||||>0.05
73918616|NCT01111149|147365286|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Number of Cigarettes Smoked (Week 12)||||>0.05
74027774|NCT00641147|147608919|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
74027775|NCT00641147|147608920|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
74027776|NCT00641147|147608921|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
74027777|NCT00641147|147608922|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
74027778|NCT00641147|147608923|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
74027779|NCT00641147|147608924|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
74027780|NCT00641147|147608928|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
74027781|NCT01629667|147608934|SUPERIORITY_OR_OTHER||Least square mean difference|-1.77||||0.14|TWO_SIDED|95.0|-4.13|0.59|||ANCOVA|||||0.59|-4.13|0.140
74027782|NCT01629667|147608934|SUPERIORITY_OR_OTHER||Least square mean difference|-1.41||||0.234|TWO_SIDED|95.0|-3.73|0.91|||ANCOVA|||||0.91|-3.73|0.234
74027783|NCT02424149|147608960|SUPERIORITY_OR_OTHER|||||||0.77|||||||t-test, 2 sided|||||||0.77
74027784|NCT02424149|147608961|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
74027785|NCT02424149|147608962|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
73918617|NCT01111149|147365287|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)||||>0.05
73918618|NCT01111149|147365288|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Pulse (Week 12)||||>0.05
73918619|NCT01111149|147365289|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicidal Ideation (Week 12)||||>0.05
73918620|NCT01111149|147365289|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicide Attempts (Week 12)||||>0.05
73918621|NCT01111149|147365290|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Composite Score - Week 12||||>0.05
73966815|NCT02910713|147470468|SUPERIORITY||Least Squares Mean Difference|-13.36|STANDARD_ERROR_OF_MEAN|1.999|<|0.0001|TWO_SIDED|95.0|-17.31|-9.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA|||||-9.40|-17.31|<0.0001
73966816|NCT02910713|147470469|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA|||||-0.40|-0.80|<0.0001
73966817|NCT02520063|147470470|OTHER||||||||||||||||||The primary analysis was of safety and included all patients who received at least one dose of the investigational regimen. The rate of adverse events was be estimated at the end of the study along with two-sided 95% exact CIs (Clopper-Pearson intervals).|||
73966818|NCT05338086|147470484|EQUIVALENCE|The estimated mean difference in %CfB lumbar spine BMD at Month 12 was presented with 95% CI and equivalence was concluded if this fell within the predefined equivalence margin of \[-1.45%, 1.45%\].|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.51|0.91||Mixed-model for repeated measures (MMRM)|Mixed Models Analysis|MMRM included treatment, with stratification variables as classification factors and baseline BMD as a continuous covariate.||||0.91|-0.51|
73918622|NCT01111149|147365290|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Global - Week 12||||>0.05
73966819|NCT05338086|147470485|EQUIVALENCE|The estimated mean difference in %CfB lumbar spine BMD at Month 12 was presented with 95% CI and equivalence was concluded if this fell within the predefined equivalence margin of \[-1.45%, 1.45%\].|Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.69|0.74|||ANCOVA|ANCOVA included terms for treatment, with stratification variables as classification factors and baseline BMD included as a continuous covariate.|The estimated mean difference in %CfB lumbar spine BMD results was pooled using Rubin's methods and presented with 95% CI.|||0.74|-0.69|
73966820|NCT05338086|147470488|EQUIVALENCE|Equivalence criteria (analysis set mFAS): 95% CI for ratio of geometric LS mean ratios contained in acceptance limits (80.00%, 125.00%).|Ratio of Geometric means|99.91|||||TWO_SIDED|95.0|91.99|108.52|||ANCOVA|ANCOVA model including log-transformed baseline sCTX as a continuous covariate with treatment and stratification variables as fixed effects.||||108.52|91.99|
73966821|NCT05338086|147470489|EQUIVALENCE|Biosimilarity with respect to PD was concluded if the 95% CI for the test (MB09) to reference (EU-Prolia) ratios of the geometric LS means was contained within the \[80.00%, 125.00%\] interval.|Ratio of Geometric means|99.13|||||TWO_SIDED|95.0|96.31|102.02|||ANCOVA|||||102.02|96.31|
74086535|NCT04947150|147726585|SUPERIORITY|||||||0.01||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated Measures ANOVA||||||.010
74086536|NCT04947150|147726586|SUPERIORITY|||||||0.073||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.073
73918623|NCT01111149|147365290|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Hallucinations - Week 12||||>0.05
73918624|NCT01111149|147365290|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Delusions - Week 12||||>0.05
73918625|NCT01111149|147365290|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for SAPS Bizarre Behavior - Week 12||||>0.05
73918626|NCT01111149|147365290|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Thought Disorder - Week 12||||>0.05
73918627|NCT01111149|147365291|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Total - Week 12||||>0.05
73918628|NCT01111149|147365291|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Positive Subscale - Week 12||||>0.05
73918629|NCT01111149|147365291|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Negative Subscale - Week 12||||>0.05
73918630|NCT01111149|147365291|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Mania Subscale - Week 12||||>0.05
73918631|NCT01111149|147365291|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Disorientation Subscale - Week 12||||>0.05
73918632|NCT01111149|147365291|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Depression Subscale - Week 12||||>0.05
73918633|NCT01111149|147365292|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Hit Reaction Time - CPT (Week 12)||||>0.05
73918634|NCT01111149|147365293|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Variability of Standard Error - CPT (Week 12)||||>0.05
73918635|NCT01111149|147365294|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Detectibility (d') of Continuous Performance Test (Week 12)||||>0.05
73918636|NCT01111149|147365295|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Response Style Indicator (Beta) for CPT (week 12)||||>0.05
73918637|NCT01111149|147365296|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Total (Week 12)||||>0.05
73918638|NCT01111149|147365296|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for WISDM Cognition (Week 12)||||>0.05
73966822|NCT05338086|147470490|EQUIVALENCE|Equivalence criteria (on Pharmacokinetic Parameter Analysis Set): the 95% CIs around the geometric LS mean contained in the acceptance limits (80.00%, 125.00%)|LS Geometric Mean Ratio|104.13|||||TWO_SIDED|95.0|98.83|109.71|||ANCOVA|Cmax was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.||||109.71|98.83|
73966823|NCT05338086|147470491|EQUIVALENCE|Equivalence criteria (on Pharmacokinetic Parameter Analysis Set): the 95% CIs around the geometric LS mean contained in the acceptance limits (80.00%, 125.00%)|LS Geometric Mean Ratio|106.06|||||TWO_SIDED|95.0|99.84|112.66|||ANCOVA|AUC0-6 months was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.||||112.66|99.84|
74027786|NCT02424149|147608963|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
74027787|NCT02424149|147608964|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||||||0.04
73918639|NCT01111149|147365296|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Craving (Week 12)||||>0.05
73918640|NCT01111149|147365297|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Urge to Smoke (Week 12)||||>0.05
74086537|NCT04947150|147726587|SUPERIORITY|||||||0.872||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.872
74086538|NCT04947150|147726588|SUPERIORITY|||||||0.145||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated Measures ANOVA||||||.145
74086539|NCT04947150|147726589|SUPERIORITY|||||||0.173||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.173
74086540|NCT04947150|147726590|SUPERIORITY|||||||0.012||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.012
74086541|NCT04947150|147726591|SUPERIORITY|||||||0.008||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.008
73918641|NCT01111149|147365297|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Strong Urge (Week 12)||||>0.05
73918642|NCT01111149|147365298|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Total (Week 12)||||>0.05
73918643|NCT01111149|147365298|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Severity Index (Week 12)||||>0.05
73918644|NCT01111149|147365298|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for AIMS Global Score (Week 12)||||>0.05
73918645|NCT00356369|147365330|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was greater than (\>) -15%.|Difference in % for rSBA-MenA antibodies|13.0|||||TWO_SIDED|95.0|3.52|23.5||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||23.5|3.52|
73918646|NCT00356369|147365330|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenC antibodies|4.18|||||TWO_SIDED|95.0|-1.03|11.36||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||11.36|-1.03|
73918647|NCT00356369|147365330|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in%for rSBA-MenW-135 antibody|4.58|||||TWO_SIDED|95.0|-0.07|11.49||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||11.49|-0.07|
73918648|NCT00356369|147365330|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenY antibodies|8.05|||||TWO_SIDED|95.0|1.72|16.17||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||16.17|1.72|
74086542|NCT04947150|147726592|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
74086543|NCT04947150|147726593|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
74086544|NCT04947150|147726594|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
74086545|NCT04947150|147726595|SUPERIORITY|||||||0.382||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.382
74086546|NCT04947150|147726596|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||<.001
74086547|NCT04947150|147726597|SUPERIORITY|||||||0.178||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.178
73918649|NCT00356369|147365331|NON_INFERIORITY|Criterion indicative of non-inferiority: Upper limit of the standardized asymptotic 95% CI on the difference between MenACWY- TT and (minus) MenACWY in the incidence of Grade 3 systemic symptoms was below 5%.|Difference in % Grade 3 general symptoms|1.34|||||TWO_SIDED|95.0|-1.64|3.09||||||To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed MenACWY vaccine in terms of the incidence of any Grade 3 systemic symptom within 4 days after vaccination.||3.09|-1.64|
73918650|NCT02408315|147365374|NON_INFERIORITY|Estimates obtained from Kaplan-Meier method and results of Log-rank test. P-value for non-inferiority hypothesis based on Cox proportional hazards model (H0: HR ≤ 0.74 vs. HA: HR \> .74), p-value \< .05 provides evidence to reject inferiority and conclude BM is non-inferior to VM.||||||0.663|||||||Cox proportional|||||||0.663
74086548|NCT04947150|147726598|SUPERIORITY|||||||0.081||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.081
74086549|NCT04947150|147726599|SUPERIORITY|||||||0.343||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.343
74086550|NCT04947150|147726600|SUPERIORITY|||||||0.369||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.369
74086551|NCT04947150|147726601|SUPERIORITY|||||||0.055||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.055
74086552|NCT04947150|147726604|SUPERIORITY|||||||0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.001
73918651|NCT01985867|147365387|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19||||0.399|TWO_SIDED|95.0|0.24|1.5|||risk analysis (prospective)|||||1.5|0.24|0.399
74086553|NCT04947150|147726605|SUPERIORITY|||||||0.079||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.079
74086554|NCT04947150|147726606|SUPERIORITY|||||||0.581||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.581
73966824|NCT04521478|147470542|OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|2.2||0.7636|TWO_SIDED|90.0|-3.0|4.3|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.3|-3.0|0.7636
73918652|NCT01985867|147365388|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.2||||0.589|TWO_SIDED|95.0|-0.6|0.7|||Wilcoxon (Mann-Whitney)|||||0.7|-0.6|0.589
73918653|NCT01985867|147365389|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.0||||0.005|TWO_SIDED|95.0|0.5|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|0.5|0.005
73918654|NCT01985867|147365390|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.659|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.659
73918655|NCT01985867|147365391|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.79|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.790
73918656|NCT01985867|147365392|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.698|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.698
73918657|NCT01985867|147365393|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.3||||0.12|TWO_SIDED|95.0|0.9|6.2|||risk analysis (prospective)|||||6.2|0.9|0.120
73918658|NCT01985867|147365394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||||||0.116
73918659|NCT01985867|147365395|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.5||||0.612|TWO_SIDED|95.0|-0.6|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|-0.6|0.612
73918660|NCT01985867|147365396|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.0||||0.004|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.0|0.0|0.004
73918661|NCT01985867|147365397|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.708|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.708
73918662|NCT01985867|147365398|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.522|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|-1.0|0.522
73918663|NCT01985867|147365399|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.185|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|0.0|0.185
73966825|NCT04521478|147470542|OTHER||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|2.2||0.304|TWO_SIDED|90.0|-1.4|5.9|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.9|-1.4|0.3040
74027788|NCT01512368|147608998|SUPERIORITY_OR_OTHER||Slope|0.089|STANDARD_ERROR_OF_MEAN|0.063|<|0.001|TWO_SIDED|95.0|0.034|0.144||All reported p values are based on two-sided tests considering ≤0.05 as significant.|Regression, Linear|Adjusted for age, time of exercise, creatinine, waist to hip ratio, fat percentage, body mass index, mean rest heart rate, blood pressure.|Metabolic equivalents (METs) consumed were independently associated with the log of delta (final-basal) FGF21 levels.|"FGF21 was log transformed to approximate normality before analyses. Null hypothesis was Ho = Y1 (FGF21 level at baseline) = Y2 (FGF21 level after two weeks of exercising). Power calculation was 80% with 60 participants evaluated (one group). To evaluate the effect of exercise on clinical and biochemical parameters, we used the difference between final - basal levels (delta)."||0.144|0.034|<0.001
74027789|NCT03237845|147609092|SUPERIORITY||Risk Difference (RD)|7.6||||0.0006|TWO_SIDED|95.0|3.3|11.9|||Cochran-Mantel-Haenszel|||||11.9|3.3|0.0006
73918664|NCT01985867|147365400|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.973|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.973
73918665|NCT01985867|147365401|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.642|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.642
73918666|NCT03530098|147365414|SUPERIORITY||Odds Ratio (OR)|-0.59||||0.04|TWO_SIDED|95.0|-1.14|-0.04|||t-test, 2 sided|||||-0.04|-1.14|0.04
73918667|NCT03530098|147365415|OTHER|||||||0.001|||||||Wilcoxon rank-sum test|||||||0.001
74027790|NCT03237845|147609093|SUPERIORITY||Risk Difference (RD)|12.4|||<|0.0001|TWO_SIDED|95.0|6.9|17.9|||Cochran-Mantel-Haenszel|||||17.9|6.9|< 0.0001
73918668|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.01||||90.0|-0.041|-0.007|||ANCOVA|||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.007|-0.041|
73918669|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.011||||90.0|-0.04|-0.003|||ANCOVA|||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.003|-0.040|
73918670|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.012||||90.0|-0.038|0.001|||ANCOVA|||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.001|-0.038|
73918671|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.012||||90.0|-0.058|-0.019|||ANCOVA|||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.019|-0.058|
73918672|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.065|-0.02|||ANCOVA|||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.020|-0.065|
74027791|NCT03237845|147609094|SUPERIORITY||Risk Difference (RD)|15.1|||<|0.0001|TWO_SIDED|95.0|9.4|20.8|||Cochran-Mantel-Haenszel|||||20.8|9.4|< 0.0001
74027792|NCT03237845|147609095|SUPERIORITY||Risk Difference (RD)|9.9||||0.0039|TWO_SIDED|95.0|3.2|16.6|||Cochran-Mantel-Haenszel|||||16.6|3.2|0.0039
74027793|NCT03237845|147609096|SUPERIORITY||Risk Difference (RD)|15.3|||<|0.0001|TWO_SIDED|95.0|9.4|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.4|< 0.0001
73918673|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.043|0.002|||ANCOVA|||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.002|-0.043|
73918674|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.066|-0.02|||ANCOVA|||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.020|-0.066|
73918675|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.058|-0.009|||ANCOVA|||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.009|-0.058|
73918676|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.039|0.009|||ANCOVA|||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.009|-0.039|
73918677|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.027|0.017|||ANCOVA|||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.017|-0.027|
73918678|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.037|0.012|||ANCOVA|||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.012|-0.037|
73918679|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.076|-0.014|||ANCOVA|||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.014|-0.076|
73918680|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.076|-0.013|||ANCOVA|||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.013|-0.076|
73918681|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.071|-0.008|||ANCOVA|||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.008|-0.071|
73918682|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.02||||90.0|-0.074|-0.008|||ANCOVA|||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.008|-0.074|
73918683|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.088|-0.025|||ANCOVA|||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.025|-0.088|
73918684|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.071|-0.007|||ANCOVA|||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.007|-0.071|
73918685|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.021||||90.0|-0.079|-0.01|||ANCOVA|||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.010|-0.079|
73918686|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.055|0.016|||ANCOVA|||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.016|-0.055|
73918687|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.079|-0.004|||ANCOVA|||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.004|-0.079|
73918688|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.055|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.091|-0.019|||ANCOVA|||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.019|-0.091|
73918689|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.081|-0.01|||ANCOVA|||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.010|-0.081|
73918690|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.073|0.002|||ANCOVA|||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.002|-0.073|
73918691|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.121|-0.038|||ANCOVA|||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.038|-0.121|
73918692|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.038||||90.0|-0.124|0.003|||ANCOVA|||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.003|-0.124|
74086555|NCT04947150|147726607|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
73966826|NCT04521478|147470542|OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|2.2||0.309|TWO_SIDED|90.0|-1.4|5.7|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.7|-1.4|0.3090
73918693|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.02||||90.0|-0.098|-0.033|||ANCOVA|||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.033|-0.098|
73918694|NCT00137046|147365439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.004|||ANCOVA|||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.004|-0.085|
73918695|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.055||||90.0|-0.06|0.122|||ANCOVA|||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.122|-0.060|
73918696|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.062||||90.0|0.033|0.239|||ANCOVA|||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.239|0.033|
73918697|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.068||||90.0|0.0|0.224|||ANCOVA|||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.224|-0.000|
73918698|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.257|STANDARD_ERROR_OF_MEAN|0.071||||90.0|0.141|0.374|||ANCOVA|||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.374|0.141|
73918699|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.071||||90.0|0.04|0.273|||ANCOVA|||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.273|0.040|
73918700|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.072||||90.0|0.065|0.3|||ANCOVA|||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.300|0.065|
73918701|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.078||||90.0|0.06|0.319|||ANCOVA|||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.319|0.060|
73918702|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.316|STANDARD_ERROR_OF_MEAN|0.077||||90.0|0.19|0.443|||ANCOVA|||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.443|0.190|
73918703|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.079||||90.0|-0.037|0.224|||ANCOVA|||Follow-up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.224|-0.037|
73918704|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.075||||90.0|-0.103|0.145|||ANCOVA|||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.145|-0.103|
73918705|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.082||||90.0|-0.023|0.248|||ANCOVA|||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.248|-0.023|
73918706|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.273|STANDARD_ERROR_OF_MEAN|0.089||||90.0|0.126|0.419|||ANCOVA|||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.419|0.126|
73918707|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|0.087||||90.0|0.219|0.507|||ANCOVA|||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.507|0.219|
73918708|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.091||||90.0|0.128|0.428|||ANCOVA|||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.428|0.128|
73918709|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|STANDARD_ERROR_OF_MEAN|0.091||||90.0|0.144|0.442|||ANCOVA|||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.442|0.144|
73918710|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.094||||90.0|0.058|0.369|||ANCOVA|||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.369|0.058|
73918711|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.086||||90.0|0.101|0.386|||ANCOVA|||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.386|0.101|
74027794|NCT03237845|147609097|SUPERIORITY||Risk Difference (RD)|4.8||||0.2084|TWO_SIDED|95.0|-2.7|12.2||P-Value ≥ 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.2|-2.7|0.2084
73918712|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.09||||90.0|0.079|0.376|||ANCOVA|||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.376|0.079|
74027795|NCT03291197|147609112|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Our study was not powered to perform statistical analysis though was still conduct to look for a trend in reduction of VAS.||||0.043
73918713|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.089||||90.0|0.079|0.372|||ANCOVA|||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.372|0.079|
73918714|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.095||||90.0|0.055|0.368|||ANCOVA|||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.368|0.055|
73918715|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.092||||90.0|0.18|0.483|||ANCOVA|||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.483|0.180|
73918716|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462|STANDARD_ERROR_OF_MEAN|0.097||||90.0|0.302|0.622|||ANCOVA|||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.622|0.302|
73918717|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.115||||90.0|0.221|0.6|||ANCOVA|||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.600|0.221|
73918718|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.451|STANDARD_ERROR_OF_MEAN|0.161||||90.0|0.183|0.718|||ANCOVA|||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.718|0.183|
73918719|NCT00137046|147365441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.174|0.237|||ANCOVA|||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.237|-0.174|
73918720|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.81|STANDARD_ERROR_OF_MEAN|6.33||||90.0|-25.24|-4.39|||ANCOVA|||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.39|-25.24|
73918721|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.83|STANDARD_ERROR_OF_MEAN|6.27||||90.0|-35.16|-14.51|||ANCOVA|||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.51|-35.16|
73918722|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.16|STANDARD_ERROR_OF_MEAN|6.92||||90.0|-37.56|-14.75|||ANCOVA|||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.75|-37.56|
73918723|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.46|STANDARD_ERROR_OF_MEAN|6.74||||90.0|-30.56|-8.36|||ANCOVA|||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-8.36|-30.56|
73918724|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.97|STANDARD_ERROR_OF_MEAN|6.65||||90.0|-50.93|-29.0|||ANCOVA|||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-29.00|-50.93|
74027796|NCT01645280|147609114|SUPERIORITY_OR_OTHER|||||||0.184|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.184
73918725|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|STANDARD_ERROR_OF_MEAN|7.02||||90.0|-27.65|-4.51|||ANCOVA|||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.51|-27.65|
73918726|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.54|STANDARD_ERROR_OF_MEAN|6.76||||90.0|-24.69|-2.39|||ANCOVA|||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-2.39|-24.69|
73918727|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.86|STANDARD_ERROR_OF_MEAN|7.29||||90.0|-30.88|-6.84|||ANCOVA|||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-6.84|-30.88|
73918728|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|8.12||||90.0|-9.83|16.96|||ANCOVA|||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin.Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||16.96|-9.83|
73918729|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|8.2||||90.0|-31.32|-4.27|||ANCOVA|||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.27|-31.32|
73918730|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.71|STANDARD_ERROR_OF_MEAN|7.72||||90.0|-33.44|-7.99|||ANCOVA|||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-7.99|-33.44|
73918731|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|7.8||||90.0|-11.06|14.66|||ANCOVA|||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||14.66|-11.06|
73918732|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.72|STANDARD_ERROR_OF_MEAN|9.02||||90.0|-23.61|6.17|||ANCOVA|||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||6.17|-23.61|
74027797|NCT01645280|147609114|SUPERIORITY_OR_OTHER|||||||0.13|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.130
74027798|NCT01645280|147609114|SUPERIORITY_OR_OTHER|||||||0.642|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.642
74027799|NCT01645280|147609114|SUPERIORITY_OR_OTHER|||||||0.832|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.832
74027800|NCT01645280|147609115|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.019
74086556|NCT04947150|147726608|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
74086557|NCT04947150|147726609|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
74086558|NCT04947150|147726610|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
73918733|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.34|STANDARD_ERROR_OF_MEAN|7.84||||90.0|-29.28|-3.4|||ANCOVA|||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-3.40|-29.28|
73918734|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.99|STANDARD_ERROR_OF_MEAN|8.25||||90.0|-26.6|0.63|||ANCOVA|||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||0.63|-26.60|
73918735|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.22|STANDARD_ERROR_OF_MEAN|8.58||||90.0|-24.39|3.94|||ANCOVA|||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||3.94|-24.39|
73918736|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.64|STANDARD_ERROR_OF_MEAN|8.82||||90.0|-43.19|-14.09|||ANCOVA|||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.09|-43.19|
73918737|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.99|STANDARD_ERROR_OF_MEAN|8.91||||90.0|-23.69|5.71|||ANCOVA|||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||5.71|-23.69|
73918738|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|STANDARD_ERROR_OF_MEAN|8.8||||90.0|-24.04|5.0|||ANCOVA|||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||5.00|-24.04|
73918739|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|8.67||||90.0|-24.71|3.92|||ANCOVA|||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||3.92|-24.71|
73918740|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.17|STANDARD_ERROR_OF_MEAN|9.24||||90.0|-21.42|9.09|||ANCOVA|||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||9.09|-21.42|
73918741|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|9.44||||90.0|-20.98|10.21|||ANCOVA|||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||10.21|-20.98|
73918742|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.58|STANDARD_ERROR_OF_MEAN|13.77||||90.0|-38.43|7.26|||ANCOVA|||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||7.26|-38.43|
73918743|NCT00137046|147365444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84|STANDARD_ERROR_OF_MEAN|11.27||||90.0|-15.79|21.46|||ANCOVA|||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||21.46|-15.79|
73918744|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.523|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.846|-0.199|||ANCOVA|||Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.199|-0.846|
73966827|NCT04521478|147470542|OTHER||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|1.7||0.3694|TWO_SIDED|90.0|-1.3|4.4|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.4|-1.3|0.3694
74086559|NCT04947150|147726614|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired Sample T-test||||||<.05
73918745|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.113|STANDARD_ERROR_OF_MEAN|0.26||||90.0|-1.541|-0.685|||ANCOVA|||Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.685|-1.541|
74086560|NCT04947150|147726616|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|Paired samples t-test||||||.006
74086561|NCT04947150|147726617|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired samples t-test||||||<.001
74086562|NCT04947150|147726618|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|Paired samples t-test||||||.220
74086563|NCT04947150|147726619|SUPERIORITY|||||||0.623|||||||t-test, 2 sided|Paired samples t-test||||||.623
74086564|NCT04947150|147726620|SUPERIORITY|||||||0.577||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.577
74086565|NCT04947150|147726621|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
74086566|NCT04947150|147726622|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
74086567|NCT04947150|147726623|SUPERIORITY|||||||0.008||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.008
73918746|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.359|STANDARD_ERROR_OF_MEAN|0.29||||90.0|-1.836|-0.882|||ANCOVA|||Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.882|-1.836|
73918747|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.184|STANDARD_ERROR_OF_MEAN|0.314||||90.0|-1.702|-0.666|||ANCOVA|||Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.666|-1.702|
73918748|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.338||||90.0|-1.984|-0.869|||ANCOVA|||Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.869|-1.984|
73918749|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.717|STANDARD_ERROR_OF_MEAN|0.384||||90.0|-2.35|-1.084|||ANCOVA|||Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.084|-2.350|
73918750|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.273|STANDARD_ERROR_OF_MEAN|0.411||||90.0|-1.95|-0.596|||ANCOVA|||Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.596|-1.950|
73918751|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.069|STANDARD_ERROR_OF_MEAN|0.439||||90.0|-1.792|-0.346|||ANCOVA|||Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.346|-1.792|
73918752|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.785|STANDARD_ERROR_OF_MEAN|0.418||||90.0|-1.475|-0.096|||ANCOVA|||Follow-up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.096|-1.475|
73918753|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.445|STANDARD_ERROR_OF_MEAN|0.406||||90.0|-1.114|0.224|||ANCOVA|||Follow-up Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||0.224|-1.114|
73918754|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.654||||90.0|-1.133|1.025|||ANCOVA|||Extension Month 1; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||1.025|-1.133|
73918755|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.336|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-2.438|-0.235|||ANCOVA|||Extension Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.235|-2.438|
73918756|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.462|STANDARD_ERROR_OF_MEAN|0.542||||90.0|-2.356|-0.568|||ANCOVA|||Extension Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.568|-2.356|
73918757|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.385|STANDARD_ERROR_OF_MEAN|0.564||||90.0|-2.316|-0.454|||ANCOVA|||Extension Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.454|-2.316|
73918758|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.955|STANDARD_ERROR_OF_MEAN|0.559||||90.0|-1.877|-0.034|||ANCOVA|||Extension Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.034|-1.877|
73918759|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.588||||90.0|-1.97|-0.03|||ANCOVA|||Extension Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.030|-1.970|
73918760|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.655||||90.0|-2.041|0.121|||ANCOVA|||Extension Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||0.121|-2.041|
73918761|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.667|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-2.77|-0.565|||ANCOVA|||Extension Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.565|-2.770|
73918762|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.872|STANDARD_ERROR_OF_MEAN|0.692||||90.0|-3.013|-0.73|||ANCOVA|||Extension Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.730|-3.013|
73918763|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.887|STANDARD_ERROR_OF_MEAN|0.725||||90.0|-3.084|-0.69|||ANCOVA|||Extension Month 27; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.690|-3.084|
73918764|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.794|STANDARD_ERROR_OF_MEAN|0.891||||90.0|-4.264|-1.324|||ANCOVA|||Extension Month 30; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.324|-4.264|
73918765|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.287|STANDARD_ERROR_OF_MEAN|1.091||||90.0|-5.088|-1.485|||ANCOVA|||Extension Month 33; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.485|-5.088|
73918766|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.486|STANDARD_ERROR_OF_MEAN|0.857||||90.0|-2.901|-0.071|||ANCOVA|||Extension Month 36; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.071|-2.901|
73918767|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.131|STANDARD_ERROR_OF_MEAN|1.356||||90.0|-5.382|-0.88|||ANCOVA|||Extension Month 39; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.880|-5.382|
73918768|NCT00137046|147365445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.487|STANDARD_ERROR_OF_MEAN|0.866||||90.0|-2.918|-0.055|||ANCOVA|||Extension Follow Up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.055|-2.918|
73918769|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.744|STANDARD_ERROR_OF_MEAN|0.144||||90.0|-0.981|-0.506|||ANCOVA|||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.506|-0.981|
73918770|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.797|STANDARD_ERROR_OF_MEAN|0.167||||90.0|-1.073|-0.522|||ANCOVA|||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.522|-1.073|
73918771|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.667|STANDARD_ERROR_OF_MEAN|0.171||||90.0|-0.949|-0.384|||ANCOVA|||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.384|-0.949|
73918772|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|0.181||||90.0|-1.123|-0.528|||ANCOVA|||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.528|-1.123|
73918773|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.19||||90.0|-0.923|-0.296|||ANCOVA|||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.296|-0.923|
73918774|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.577|STANDARD_ERROR_OF_MEAN|0.202||||90.0|-0.91|-0.245|||ANCOVA|||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.245|-0.910|
73918775|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.613|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-0.962|-0.263|||ANCOVA|||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.263|-0.962|
73918776|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.385|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.736|-0.034|||ANCOVA|||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.034|-0.736|
73918777|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.211||||90.0|-0.197|0.497|||ANCOVA|||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.497|-0.197|
73918778|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.16|0.492|||ANCOVA|||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.492|-0.160|
73918779|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.208||||90.0|-0.274|0.411|||ANCOVA|||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.411|-0.274|
73918780|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.252||||90.0|-0.876|-0.043|||ANCOVA|||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.043|-0.876|
73918781|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.579|STANDARD_ERROR_OF_MEAN|0.247||||90.0|-0.986|-0.172|||ANCOVA|||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.172|-0.986|
73918782|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.255||||90.0|-0.88|-0.04|||ANCOVA|||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.040|-0.880|
73918783|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.385|STANDARD_ERROR_OF_MEAN|0.265||||90.0|-0.822|0.053|||ANCOVA|||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.053|-0.822|
73918784|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.268||||90.0|-1.372|-0.487|||ANCOVA|||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.487|-1.372|
73918785|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.823|STANDARD_ERROR_OF_MEAN|0.286||||90.0|-1.296|-0.351|||ANCOVA|||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.351|-1.296|
73918786|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.525|STANDARD_ERROR_OF_MEAN|0.267||||90.0|-0.965|-0.084|||ANCOVA|||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.084|-0.965|
73918787|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.647|STANDARD_ERROR_OF_MEAN|0.276||||90.0|-1.104|-0.191|||ANCOVA|||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.191|-1.104|
73918788|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.853|STANDARD_ERROR_OF_MEAN|0.295||||90.0|-1.34|-0.367|||ANCOVA|||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.367|-1.340|
74027801|NCT01645280|147609115|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.025
74086568|NCT04947150|147726624|SUPERIORITY|||||||0.601||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.601
73918789|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.303||||90.0|-0.89|0.111|||ANCOVA|||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.111|-0.890|
73918790|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.636|STANDARD_ERROR_OF_MEAN|0.293||||90.0|-1.119|-0.153|||ANCOVA|||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.153|-1.119|
73918791|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.522|STANDARD_ERROR_OF_MEAN|0.29||||90.0|-1.0|-0.043|||ANCOVA|||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.043|-1.000|
73966828|NCT04521478|147470542|OTHER|||||||0.9158|||||||MCPMod Linear model|No parameter assumptions required. Corresponding dose response is linear||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9158
74086569|NCT04947150|147726625|SUPERIORITY|||||||0.088||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.088
74086570|NCT04947150|147726626|SUPERIORITY|||||||0.21||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.210
74086571|NCT04947150|147726627|SUPERIORITY|||||||0.06||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.060
74086572|NCT04947150|147726628|SUPERIORITY|||||||0.37||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.370
74086573|NCT04947150|147726629|SUPERIORITY|||||||0.556||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.556
73918792|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.744|STANDARD_ERROR_OF_MEAN|0.346||||90.0|-1.315|-0.173|||ANCOVA|||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.173|-1.315|
73918793|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.378|STANDARD_ERROR_OF_MEAN|0.628||||90.0|-2.42|-0.335|||ANCOVA|||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.335|-2.420|
74086574|NCT04947150|147726630|SUPERIORITY|||||||0.913||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.913
74086575|NCT04947150|147726631|SUPERIORITY|||||||0.241||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.241
74086576|NCT04100096|147726636|SUPERIORITY||Least Square (LS) Mean Difference|-1.02||||0.243|TWO_SIDED|95.0|-2.75|0.7||Comparison was carried out using MMRM, with study center (pooled), treatment group (TG), visit, ADT status, and TG by visit interaction (BVI), gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.|MMRM|||||0.70|-2.75|0.2430
74086577|NCT04100096|147726637|SUPERIORITY||LS Mean Difference|-0.04||||0.7759|TWO_SIDED|95.0|-0.35|0.27||Comparison was carried out using MMRM, with study center (pooled), TG, visit, ADT status, and TG BVI, gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.|MMRM|||||0.27|-0.35|0.7759
73918794|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-1.183|-0.258|||ANCOVA|||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.258|-1.183|
73918795|NCT00137046|147365454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.323||||90.0|-0.594|0.472|||ANCOVA|||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.472|-0.594|
73918796|NCT02725710|147365463|OTHER|||||||0.56|||||||Regression, Linear|||||||0.56
73966829|NCT04521478|147470542|OTHER|||||||0.8676|||||||MCPMod Exponential model|Assumption: 5% of the maximum effect is achieved at 25 mg; corresponding to a drug effect achieved mainly at higher doses||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.8676
73966830|NCT04521478|147470542|OTHER|||||||0.9552|||||||MCPMod Emax1 model|Assumption: 50% of the maximum effect is achieved at 25 mg; corresponding to the assumed true median effective dose (ED50) = 25 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9552
73966831|NCT04521478|147470542|OTHER|||||||0.9619|||||||MCPMod Emax2 model|Assumption: 70% of the maximum effect is achieved at 5 mg; corresponding to a drug effect achieved mainly with low doses, ED50 = 2.14 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9619
73861180|NCT01726673|147268530|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|208.5||||0.592|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 36 weeks ( 6 month follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||0.592
73861181|NCT01726673|147268531|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|270.5||||0.68|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.680
73861182|NCT01726673|147268531|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month FU) was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|187.5||||0.837|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 6 month FU across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||0.837
73861183|NCT01719003|147268532|SUPERIORITY_OR_OTHER||Adjusted mean|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0056|TWO_SIDED|95.0|-0.56|-0.1|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.10|-0.56|0.0056
73861184|NCT01719003|147268532|SUPERIORITY_OR_OTHER||Adjusted mean|-0.72|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.95|-0.48|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.48|-0.95|<0.0001
73861185|NCT01719003|147268532|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.75|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.98|-0.51|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.51|-0.98|<0.0001
73861186|NCT01719003|147268532|SUPERIORITY_OR_OTHER||Adjusted mean|-0.57|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.81|-0.34|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.34|-0.81|<0.0001
73861187|NCT01719003|147268532|SUPERIORITY_OR_OTHER||Adjusted mean|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0062|TWO_SIDED|95.0|-0.56|-0.09|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment||-0.09|-0.56|0.0062
73861188|NCT01719003|147268532|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.72|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.95|-0.49|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.49|-0.95|<0.0001
73861189|NCT01719003|147268532|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.03|-0.56|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.56|-1.03|<0.0001
73861190|NCT01719003|147268532|SUPERIORITY_OR_OTHER||Adjusted mean|-0.63|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.86|-0.4|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.40|-0.86|<0.0001
73918797|NCT01414010|147365504|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Statistical analysis was performed using a variety of computer packages including XLstat, NCSS 2007, R and NCSS 2010"||||<0.05
73918798|NCT02142959|147365505|SUPERIORITY||LS Mean Difference Final Values|-0.1||||0.237|TWO_SIDED|65.0|-0.2|0.0||Omaveloxolone treatment arms were compared with Vehicle Lotion using a hierarchical testing strategy to control the overall type I error.|Mixed Models Analysis|Fixed factors: treatment grp \& wk of visit; covariates of site, smoking status \& surgery. Missing data imputed using each patient's worst-observation.||Comparison of omaveloxolone lotion pooled (0.5% and 3%) versus vehicle lotion||0.0|-0.2|0.237
74027802|NCT01645280|147609115|SUPERIORITY_OR_OTHER|||||||0.248|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.248
73861191|NCT01719003|147268532|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.39|STANDARD_ERROR_OF_MEAN|0.12||0.6246|TWO_SIDED|95.0|0.15|0.62|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 25 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||0.62|0.15|0.6246
74027803|NCT01645280|147609115|SUPERIORITY_OR_OTHER|||||||0.045|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.045
73861192|NCT01719003|147268532|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.4|STANDARD_ERROR_OF_MEAN|0.12||0.6558|TWO_SIDED|95.0|0.16|0.63|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 10 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||0.63|0.16|0.6558
73861193|NCT01719003|147268533|SUPERIORITY_OR_OTHER||Adjusted mean|-18.8|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-25.5|-12.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-12.2|-25.5|<0.0001
73861194|NCT01719003|147268533|SUPERIORITY_OR_OTHER||Adjusted mean|-23.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-29.7|-16.3||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-16.3|-29.7|<0.0001
73861195|NCT01719003|147268533|SUPERIORITY_OR_OTHER||Adjusted Mean|-26.7|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-33.5|-20.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-20.0|-33.5|<0.0001
73861196|NCT01719003|147268533|SUPERIORITY_OR_OTHER||Adjusted mean|-16.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-22.8|-9.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-9.2|-22.8|<0.0001
73861197|NCT01719003|147268533|SUPERIORITY_OR_OTHER||Adjusted mean|-15.6|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-22.3|-8.9||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG of double-blind treatment||-8.9|-22.3|<0.0001
73861198|NCT01719003|147268533|SUPERIORITY_OR_OTHER||Adjusted Mean|-14.8|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-21.4|-8.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-8.2|-21.4|<0.0001
74027804|NCT01645280|147609116|SUPERIORITY_OR_OTHER|||||||0.381|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.381
74027805|NCT01645280|147609116|SUPERIORITY_OR_OTHER|||||||0.543|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.543
74027806|NCT01645280|147609116|SUPERIORITY_OR_OTHER|||||||0.629|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.629
74027807|NCT01645280|147609116|SUPERIORITY_OR_OTHER|||||||0.273|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.273
74027808|NCT01645280|147609117|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.060
73861199|NCT01719003|147268533|SUPERIORITY_OR_OTHER||Adjusted Mean|-28.2|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-35.0|-21.5||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-21.5|-35.0|<0.0001
73861200|NCT01719003|147268533|SUPERIORITY_OR_OTHER||Adjusted mean|-12.6|STANDARD_ERROR_OF_MEAN|3.4||0.0002|TWO_SIDED|95.0|-19.1|-6.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-6.0|-19.1|0.0002
73918799|NCT02142959|147365505|SUPERIORITY||LS Mean Difference Final Values|-0.1|||>|0.05|TWO_SIDED|95.0|-0.2|0.0||Omaveloxolone treatment arms were compared with Vehicle Lotion using a hierarchical testing strategy to control the overall type I error.|Mixed Models Analysis|Fixed factor: treatment grp \& visit wk; Covariates: site, smoking status \& breast surgery. Missing data imputed using each patient's worst-observation||Comparison of Omaveloxolone Lotion 0.5% versus Vehicle Lotion||0.0|-0.2|>0.05
73918800|NCT02142959|147365505|SUPERIORITY||LS Mean Difference Final Values|0.0|||>|0.05|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|Fixed factor: treatment grp \& visit wk; Covariates: site, smoking status \& breast surgery. Missing data imputed using each patient's worst-observation||Comparison of Omaveloxolone Lotion 3% versus Vehicle Lotion||0.1|-0.1|>0.05
73918801|NCT00850564|147365593|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Paired t-test|||Paired t-test comparing baseline and 2 week mean overnight growth hormone||||<0.005
73918802|NCT00850564|147365594|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Paired t-test|||Paired t-test comparing insulin stimulated glucose uptake (M) between baseline and 2 week visits.||||0.61
73918803|NCT01774968|147365595|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.1||||0.3709|TWO_SIDED|95.0|-0.33|0.12|||Mixed Models Analysis|||Approximately 325 participants were to be randomized (in a 1:1 ratio of U-500R insulin TID:BID) and 260 were to complete the study (with a 20% dropout rate). The 260 completers would provide a 66.4% chance to show equivalence of TID and BID algorithms, 14.4% chance to show noninferiority of TID, 2.5% chance to superiority of TID, 14.4% chance to show noninferiority of BID, and 2.5% chance to show superiority of BID, assuming a difference in HbA1c change of 0% and a standard deviation of 1.1%.||0.12|-0.33|0.3709
73918804|NCT02044393|147365610|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.07|STANDARD_ERROR_OF_MEAN|32.1|||TWO_SIDED|90.0|62.371|87.959|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 69175 treatment (in plasma)||87.959|62.371|
73918805|NCT02044393|147365610|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|86.35|STANDARD_ERROR_OF_MEAN|18.6|||TWO_SIDED|90.0|78.04|95.56|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)||95.56|78.04|
73918806|NCT02044393|147365611|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|95.59|STANDARD_ERROR_OF_MEAN|23.5|||TWO_SIDED|90.0|84.195|108.537|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in plasma)||108.537|84.195|
73918807|NCT02044393|147365611|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|93.54|STANDARD_ERROR_OF_MEAN|15.1|||TWO_SIDED|90.0|86.142|101.57|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in whole blood)||101.570|86.142|
74027809|NCT01645280|147609117|SUPERIORITY_OR_OTHER|||||||0.134|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.134
73918808|NCT02044393|147365612|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.86|STANDARD_ERROR_OF_MEAN|32.4|||TWO_SIDED|90.0|62.946|89.035|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in plasma)||89.035|62.946|
73918809|NCT02044393|147365612|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|88.19|STANDARD_ERROR_OF_MEAN|20.7|||TWO_SIDED|90.0|78.6|98.95|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)||98.95|78.60|
74027810|NCT01645280|147609117|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.280
73918810|NCT05355805|147365614|SUPERIORITY||Risk Difference (RD)|8.27|STANDARD_ERROR_OF_MEAN|8.075||0.3055|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/Janus Kinase (JAK) inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR75."||||0.3055
74088424|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|0.1083|STANDARD_ERROR_OF_MEAN|0.3488||0.7572||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.7572
73918811|NCT05355805|147365614|SUPERIORITY||Risk Difference (RD)|4.19|STANDARD_ERROR_OF_MEAN|8.427||0.6192|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR75."||||0.6192
73918812|NCT05355805|147365617|SUPERIORITY||Risk Difference (RD)|10.14|STANDARD_ERROR_OF_MEAN|7.229||0.1606|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR90."||||0.1606
73918813|NCT05355805|147365617|SUPERIORITY||Risk Difference (RD)|4.79|STANDARD_ERROR_OF_MEAN|7.294||0.5116|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR90."||||0.5116
73918814|NCT05355805|147365618|SUPERIORITY||Risk Difference (RD)|13.67|STANDARD_ERROR_OF_MEAN|7.019||0.0514|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR100."||||0.0514
73918815|NCT05355805|147365618|SUPERIORITY||Risk Difference (RD)|6.56|STANDARD_ERROR_OF_MEAN|6.764||0.3322|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR100."||||0.3322
73918816|NCT05355805|147365619|SUPERIORITY||Risk Difference (RD)|8.63|STANDARD_ERROR_OF_MEAN|8.78||0.3258|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR50."||||0.3258
73966832|NCT04521478|147470542|OTHER|||||||0.9507|||||||MCPMod Sigmoid Emax model|Assumption: 50% of the maximum effect is achieved at 25 mg, 90% 75 mg; corresponding to a more flexible model of the assumed true ED50 = 25 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9507
73966833|NCT04521478|147470543|OTHER||Odds Ratio (OR)|0.9427||||0.8889|TWO_SIDED|90.0|0.4709|1.8873|||Regression, Logistic||5 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.8873|0.4709|0.8889
73966834|NCT04521478|147470543|OTHER||Odds Ratio (OR)|0.6581||||0.3284|TWO_SIDED|90.0|0.3255|1.3307|||Regression, Logistic||25 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.3307|0.3255|0.3284
73966835|NCT04521478|147470543|OTHER||Odds Ratio (OR)|1.1026||||0.8048|TWO_SIDED|90.0|0.5757|2.1114|||Regression, Logistic||75 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||2.1114|0.5757|0.8048
73966836|NCT04521478|147470543|OTHER||Odds Ratio (OR)|1.0072||||0.982|TWO_SIDED|90.0|0.5968|1.6999|||Regression, Logistic||125 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.6999|0.5968|0.9820
73918817|NCT05355805|147365619|SUPERIORITY||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.775||0.4068|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR50."||||0.4068
73918818|NCT05355805|147365620|SUPERIORITY|Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.|Risk Difference (RD)|-7.4|STANDARD_ERROR_OF_MEAN|7.661||0.3329|TWO_SIDED|||||The estimated risk difference divided by the standard error will be used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern."||||0.3329
73918819|NCT05355805|147365620|SUPERIORITY|Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.|Risk Difference (RD)|4.06|STANDARD_ERROR_OF_MEAN|7.574||0.5882|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern."||||0.5882
73918820|NCT05355805|147365621|SUPERIORITY||Risk Difference (RD)|7.31|STANDARD_ERROR_OF_MEAN|11.995||0.5422|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.5422
73918821|NCT05355805|147365621|SUPERIORITY||Risk Difference (RD)|-5.23|STANDARD_ERROR_OF_MEAN|11.77||0.6569|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.6569
73918822|NCT05355805|147365622|SUPERIORITY||Risk Difference (RD)|7.48|STANDARD_ERROR_OF_MEAN|8.951||0.4031|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.4031
73966837|NCT04521478|147470544|OTHER||Mean Difference (Net)|4.3|STANDARD_ERROR_OF_MEAN|2.6||0.1013|TWO_SIDED|90.0|0.0|8.6|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.6|0.0|0.1013
73966838|NCT04521478|147470544|OTHER||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|2.6||0.3596|TWO_SIDED|90.0|-1.9|6.6|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.6|-1.9|0.3596
74086578|NCT04100096|147726638|SUPERIORITY||LS Mean Difference|-0.06||||0.6585|TWO_SIDED|95.0|-0.32|0.2||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 2||0.20|-0.32|0.6585
74088425|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0307|STANDARD_ERROR_OF_MEAN|0.1809||0.8657||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever drank alcohol (No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.8657
73918823|NCT05355805|147365622|SUPERIORITY||Risk Difference (RD)|21.27|STANDARD_ERROR_OF_MEAN|9.959||0.0327|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.0327
73918824|NCT01804075|147365653|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
73918825|NCT00524368|147365654|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/rtv once daily and DRV/rtv twice daily exceeds -12%, non-inferiority of the DRV/rtv q.d. versus the DRV/rtv b.i.d. therapy was concluded.|Difference in proportion of response|0.0019|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.054|0.092|||Regression, Logistic|The model includes treatment as factor and baseline viral load (log10) as covariate.|Difference in proportion of response DRV/rtv once daily minus DRV/rtv twice daily estimated from the logistic regression model.|Assuming a response rate of 70% at 48 weeks for both treatment groups, 306 participants were required per treatment arm to establish noninferiority of darunavir (DRV)/ritonavir (rtv) once daily versus DRV/rtv twice daily with a maximum allowable difference of 12%, with a 1-sided significance level of 0.025 and 90% power.||0.092|-0.054|<0.001
73918826|NCT00524368|147365655|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of this 95% 2-sided CI of the difference between DRV/rtv q.d. and DRV/rtv b.i.d. exceeded -12%, noninferiority of DRV/rtv q.d. and DRV/rtv b.i.d. could be concluded.|Difference in proportion of response|0.007|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.06|0.075|||Regression, Logistic|A logistic regression model includes treatment as fixed factor and baseline plasma viral load as a covariate.|Difference in proportion of response between 2 treatment groups (DRV/rtv q.d. minus DRV/rtv b.i.d)|||0.075|-0.060|<0.001
73918827|NCT00524368|147365656|SUPERIORITY_OR_OTHER||Difference between least square means|-0.003|STANDARD_ERROR_OF_MEAN|0.094||0.977|TWO_SIDED|95.0|-0.188|0.182|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference between least square means between the DRV/rtv q.d. and DRV/rtv b.i.d. treatment groups at Week 48.|||0.182|-0.188|0.977
73918828|NCT00524368|147365657|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.094||0.917|TWO_SIDED|95.0|0.824|1.191|||Cox proportional hazards|Including treatment as fixed factor and baseline plasma viral load as a covariate||||1.191|0.824|0.917
73918829|NCT00524368|147365658|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.945|STANDARD_ERROR_OF_MEAN|0.154||0.716|TWO_SIDED|95.0|0.699|1.279|||Regression, Cox|Including baseline log10 viral load as covariate||||1.279|0.699|0.716
73918830|NCT00524368|147365659|SUPERIORITY_OR_OTHER||Difference in least square means|-0.03|STANDARD_ERROR_OF_MEAN|0.072||0.711|TWO_SIDED|95.0|-0.169|0.115|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference in least square means between the 2 treatment groups (DRV/rtv q.d. and DRV/rtv b.i.d)|||0.115|-0.169|0.711
73918831|NCT00524368|147365660|SUPERIORITY_OR_OTHER||Difference in least square means|-5.95|STANDARD_ERROR_OF_MEAN|10.26||0.562|TWO_SIDED|95.0|-26.09|14.2|||ANCOVA|The model includes treatment as factor and baseline CD4 count and baseline viral load (log10) as covariates.|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.|||14.20|-26.09|0.562
73918832|NCT00524368|147365661|SUPERIORITY_OR_OTHER||Difference in least square means|0.55|STANDARD_ERROR_OF_MEAN|1.79||0.761|TWO_SIDED|95.0|-2.97|4.06|||ANCOVA|Including factors for treatment, and baseline log10 plasma viral load and baseline FAHI score as covariates|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.|||4.06|-2.97|0.761
73918833|NCT01075204|147365698|SUPERIORITY_OR_OTHER|||||||0.334||95.0|||||Chi-squared|9 degrees of freedom.||Logistic regression: Omnibus Test of Model Coefficients (all the nine variables are considered together).||||0.334
73918834|NCT01752907|147365723|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.3479|TWO_SIDED|95.0|-0.4|1.0|||t-test, 2 sided||Treatment difference = bone pain DVD - general education DVD|There was no statistical hypothesis testing for this study. The clinical hypothesis was that a difference in mean maximum pain of 0.5 (scale 0 to 10) in favor of bone pain education would be a clinically relevant difference.||1.0|-0.4|0.3479
73918835|NCT02670083|147365736|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.354|||TWO_SIDED|95.0|-0.86|0.53||||||||0.53|-0.86|
73918836|NCT02670083|147365737|SUPERIORITY||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.083|||TWO_SIDED|95.0|-2.39|1.87||||||||1.87|-2.39|
74027811|NCT01645280|147609117|SUPERIORITY_OR_OTHER|||||||0.345|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.345
73918837|NCT02670083|147365738|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.006|||TWO_SIDED|95.0|-2.08|1.88||||||||1.88|-2.08|
73918838|NCT02670083|147365739|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.076|||TWO_SIDED|95.0|-0.1|0.2||||||||0.20|-0.10|
73918839|NCT02670083|147365740|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.486|||TWO_SIDED|95.0|-0.62|1.29||||||||1.29|-0.62|
73918840|NCT02670083|147365741|SUPERIORITY||Least Squares Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|1.679|||TWO_SIDED|95.0|-1.43|5.18||||||||5.18|-1.43|
73918841|NCT02670083|147365742|SUPERIORITY||Least Squares Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|1.306|||TWO_SIDED|95.0|-1.35|3.79||||||||3.79|-1.35|
73918842|NCT02670083|147365744|SUPERIORITY||Least Squares Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.723|||TWO_SIDED|95.0|-1.95|0.9||||||||0.90|-1.95|
73918843|NCT02670083|147365745|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.609|||TWO_SIDED|95.0|-0.81|1.6||||||||1.60|-0.81|
73918844|NCT02670083|147365746|SUPERIORITY||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|6.214|||TWO_SIDED|95.0|-13.64|10.86||||||||10.86|-13.64|
73918845|NCT02670083|147365747|SUPERIORITY||Least Squares Mean Difference|1.82|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.64|6.27||||||||6.27|-2.64|
73918846|NCT02670083|147365748|SUPERIORITY||Least Squares Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|2.222|||TWO_SIDED|95.0|-3.45|5.32||||||||5.32|-3.45|
74027812|NCT00234104|147609121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.0074||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0074
73918847|NCT02670083|147365754|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.24|0.22||||||||0.22|-0.24|
73918848|NCT02670083|147365755|SUPERIORITY||Least Squares Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|1.245|||TWO_SIDED|95.0|-3.72|1.17||||||||1.17|-3.72|
73918849|NCT02670083|147365756|SUPERIORITY||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.253|||TWO_SIDED|95.0|-0.1|0.89||||||||0.89|-0.10|
73918850|NCT02057406|147365767|SUPERIORITY|The EPA/DHA arm versus placebo at Week 12.||||||0.74|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.||||0.74
73918851|NCT02057406|147365767|SUPERIORITY|High EPA group versus placebo group at Week 12.||||||0.45|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.||||0.45
73918852|NCT02057406|147365768|SUPERIORITY|Active supplements (2:1 EPA/DHA and High EPA combined) versus placebo at Week 12.|||||<|0.0001|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.||||<0.0001
73918853|NCT02057406|147365768|SUPERIORITY|2:1 EPA/DHA versus High EPA at Week 12.||||||0.12|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.||||0.12
73918854|NCT02425046|147365769|SUPERIORITY|||||||0.67||||||Threshold for statistical significance \<0.05|t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||||||0.67
73918855|NCT02425046|147365770|SUPERIORITY|||||||0.735|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||null hypothesis - there will be no difference between the groups.||||0.735
73918856|NCT02425046|147365771|SUPERIORITY|||||||0.599|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||Null hypothesis that there would be no difference in change in FNPA scores between the two groups over 12 months.||||0.599
73918857|NCT02425046|147365772|SUPERIORITY|||||||0.583|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||Null hypothesis: Change in MVPA from baseline to 12 months will not be different between target children in the two groups.||||0.583
73918858|NCT02425046|147365773|SUPERIORITY|||||||0.312|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||Null hypothesis is that there will be no difference between the two arms in change in sugar sweetened beverage intake over 12 months.||||0.312
73918859|NCT02425046|147365774|SUPERIORITY||difference in change between two arms|75.0||||0.1|TWO_SIDED|95.0|-15.0|165.0|||Linear quantile mixed model|Linear quantile mixed models (a non-parametric linear mixed model) was used because of non-normal distribution that could not be transformed.|Comparison of the intervention target adult change in reported physical activity compared to the control group.|Linear quantile mixed models (a non-parametric linear mixed model) was used because because of non-normal distribution that could not be remedied by transformation.||165|-15|0.10
73918860|NCT02425046|147365775|SUPERIORITY||difference in change between two arms|-2.54||||0.057|TWO_SIDED|95.0|-5.14|0.07|||Mixed Models Analysis||The intervention arm in comparison to the control arm.|||0.07|-5.14|0.057
73918861|NCT02425046|147365776|SUPERIORITY|||||||0.874|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||||||0.874
73918862|NCT02425046|147365777|SUPERIORITY||% difference in change between arms|7.0||||0.31|TWO_SIDED|95.0|-7.0|23.0|||Mixed Models Analysis|Screen time was log transformed to normalized the distribution. Results have been back transformed from log 10 scale.|% change in screen time of the intervention arm compared to the control arm.|||23|-7|0.31
73918863|NCT02425046|147365778|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||||||0.516
73918864|NCT03654651|147365779|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-2.7|1.6|||Mixed Models Analysis|||||1.6|-2.7|
73918865|NCT03654651|147365779|OTHER|change from baseline|Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.7|0.9|||Mixed Models Analysis|||||0.9|-2.7|
73918866|NCT03654651|147365779|OTHER|Change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.2|1.4|||Mixed Models Analysis|||||1.4|-2.2|
73918867|NCT03654651|147365780|SUPERIORITY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-4.8|3.4|||Mixed Models Analysis|||||3.4|-4.8|
73918868|NCT03654651|147365780|OTHER|change from baseline|Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-5.1|5.4|||Mixed Models Analysis|||||5.4|-5.1|
73918869|NCT03654651|147365780|OTHER|change from baseline|Mean Difference (Final Values)|-3.8|||||TWO_SIDED|95.0|-5.1|5.4|||Mixed Models Analysis|||||5.4|-5.1|
73918870|NCT03654651|147365781|SUPERIORITY||Mean Difference (Final Values)|0.45|||||TWO_SIDED|95.0|-1.2|2.1|||Mixed Models Analysis|||||2.1|-1.2|
73918871|NCT03654651|147365781|OTHER|change from baseline|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-1.5|1.0|||Mixed Models Analysis|||||1.0|-1.5|
73918872|NCT03654651|147365781|OTHER|change from baseline|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.1|0.5|||Mixed Models Analysis|||||0.5|-2.1|
73918873|NCT03654651|147365782|SUPERIORITY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-3.1|4.6|||Mixed Models Analysis|||peripheral systolic BP||4.6|-3.1|
73918874|NCT03654651|147365782|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.1|2.9|||Mixed Models Analysis|||peripheral diastolic BP||2.9|-2.1|
73918875|NCT03654651|147365782|OTHER|change from baseline|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||peripheral systolic BP change from baseline||3.3|-2.5|
74086579|NCT04100096|147726638|SUPERIORITY||LS Mean Difference|-0.25||||0.1181|TWO_SIDED|95.0|-0.57|0.06||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 4||0.06|-0.57|0.1181
73918876|NCT03654651|147365782|OTHER|change from baseline|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-3.1|2.6|||Mixed Models Analysis|||peripheral systolic BP change from baseline||2.6|-3.1|
73918877|NCT03654651|147365782|OTHER|change from baseline|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.5|||Mixed Models Analysis|||peripheral diastolic BP change from baseline||2.5|-1.5|
73918878|NCT03654651|147365782|OTHER|change from baseline|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Mixed Models Analysis|||peripheral diastolic BP change from baseline||2|-2|
73918879|NCT03654651|147365783|SUPERIORITY||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.4|4.4|||Mixed Models Analysis|||central systolic BP||4.4|-2.4|
73918880|NCT03654651|147365783|SUPERIORITY||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-1.7|3.3|||Mixed Models Analysis|||central diastolic BP||3.3|-1.7|
73918881|NCT03654651|147365783|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.9|3.1|||Mixed Models Analysis|||central systolic BP change from baseline||3.1|-1.9|
73918882|NCT03654651|147365783|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.9|2.1|||Mixed Models Analysis|||central systolic BP change from baseline||2.1|-2.9|
73918883|NCT03654651|147365783|OTHER|change from baseline|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.6|||Mixed Models Analysis|||central diastolic BP change from baseline||2.6|-1.5|
73918884|NCT03654651|147365783|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.4|1.6|||Mixed Models Analysis|||central diastolic BP change from baseline||1.6|-2.4|
73918885|NCT03654651|147365784|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.1|0.5|||Mixed Models Analysis|||||0.5|-0.1|
73918886|NCT03654651|147365784|OTHER|change from baseline|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|0.1|0.6|||Mixed Models Analysis|||||0.6|0.1|
73918887|NCT03654651|147365784|OTHER|change from baseline|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|||||0.3|-0.1|
73918888|NCT03654651|147365785|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-5.9|3.3|||Mixed Models Analysis|||||3.3|-5.9|
73918889|NCT03654651|147365785|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-3.7|2.9|||Mixed Models Analysis|||||2.9|-3.7|
73918890|NCT03654651|147365785|OTHER|change from baseline|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-4.0|4.3|||Mixed Models Analysis|||||4.3|-4.0|
73918891|NCT03654651|147365786|SUPERIORITY||Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-1.4|9.8|||Mixed Models Analysis|||||9.8|-1.4|
73918892|NCT03654651|147365786|OTHER|change from baseline|Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-2.1|6.9|||Mixed Models Analysis|||||6.9|-2.1|
73918893|NCT03654651|147365786|OTHER|change from baseline|Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-6.8|2.2|||Mixed Models Analysis|||||2.2|-6.8|
73918894|NCT03654651|147365787|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.3|2.3|||Mixed Models Analysis|||||2.3|-2.3|
73918895|NCT03654651|147365787|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||||1.8|-0.6|
73918896|NCT03654651|147365787|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.6|2.3|||Mixed Models Analysis|||||2.3|-1.6|
73918897|NCT03654651|147365788|SUPERIORITY||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-3.8|8.2|||Mixed Models Analysis|||||8.2|-3.8|
73918898|NCT03654651|147365788|OTHER|change from baseline|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-4.9|5.1|||Mixed Models Analysis|||||5.1|-4.9|
73918899|NCT03654651|147365788|OTHER|change from baseline|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-7.8|2.3|||Mixed Models Analysis|||||2.3|-7.8|
73918900|NCT03654651|147365789|SUPERIORITY||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-18.3|2.8|||Mixed Models Analysis|||||2.8|-18.3|
73918901|NCT03654651|147365789|OTHER|change from baseline|Mean Difference (Final Values)|-17.0|||||TWO_SIDED|95.0|-29.1|-4.8|||Mixed Models Analysis|||||-4.8|-29.1|
73918902|NCT03654651|147365789|OTHER|change from baseline|Mean Difference (Final Values)|-5.7|||||TWO_SIDED|95.0|-17.1|5.7|||Mixed Models Analysis|||||5.7|-17.1|
73918903|NCT03654651|147365790|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|
73918904|NCT03654651|147365790|OTHER|change from baseline|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.1|1.5|||Mixed Models Analysis|||||1.5|-0.1|
73918905|NCT03654651|147365790|OTHER|change from baseline|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Mixed Models Analysis|||||0.5|-0.5|
73918906|NCT00856284|147365796|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.03|||||ONE_SIDED|98.75||0.059||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.||0.059||
74086580|NCT04100096|147726638|SUPERIORITY||LS Mean Difference|-0.19||||0.2431|TWO_SIDED|95.0|-0.51|0.13||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 6||0.13|-0.51|0.2431
73918907|NCT00856284|147365796|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||ONE_SIDED|98.75||0.003||||||||0.003||
73966839|NCT04521478|147470544|OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|2.5||0.6745|TWO_SIDED|90.0|-5.2|3.1|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||3.1|-5.2|0.6745
73966840|NCT04521478|147470544|OTHER||Mean Difference (Net)|2.7|STANDARD_ERROR_OF_MEAN|2.0||0.187|TWO_SIDED|90.0|-0.7|6.0|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.0|-0.7|0.1870
73918908|NCT00856284|147365802|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.13|||||ONE_SIDED|98.75||-0.006||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.||-0.006||
73918909|NCT00856284|147365802|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||ONE_SIDED|98.75||0.035||||||||0.035||
73918910|NCT01577329|147365806|SUPERIORITY_OR_OTHER|||||||0.05||||||This is a calculated P value and was not adjusted for multiple comparisons.|ANOVA|||This is a calculated P value comparing two groups at baseline and follow-up||||0.05
73918911|NCT02288559|147365826|SUPERIORITY||Difference in Adjusted Means|0.435||||0.0428|TWO_SIDED|80.0|0.162|0.707|||Mixed-Effect Model Repeated Measures|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.||||0.707|0.162|0.0428
73918912|NCT02288559|147365826|SUPERIORITY||Difference in Adjusted Means|-0.21||||0.3361|TWO_SIDED|80.0|-0.491|0.071|||MMRM|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.||||0.071|-0.491|0.3361
73918913|NCT00759954|147365839|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|97.19|||<|0.05||90.0|91.31|103.45|||ANOVA|||||103.45|91.31|<0.05
73966841|NCT04521478|147470544|OTHER||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|2.4||0.0921|TWO_SIDED|90.0|0.1|8.1|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.1|0.1|0.0921
74027813|NCT00234104|147609121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0459||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0459
73918914|NCT00759954|147365841|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|95.82|||<|0.05||90.0|92.93|98.8|||ANOVA|Analysis of Variance for the log-transformed AUC. The 90% confidence interval for the ratio of AUC(Test)/AUC(Ref) is provided.||||98.80|92.93|< 0.05
73918915|NCT00759954|147365842|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|98.1|||<|0.05||90.0|94.2|102.1|||ANOVA|||||102.1|94.2|< 0.05
74027814|NCT00234104|147609121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.001||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0010
74027815|NCT03849560|147609128|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for antigen H1N1 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.22|||||TWO_SIDED|95.0|0.82|1.82||||||||1.82|0.82|
74027816|NCT03849560|147609128|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for antigen H3N2 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.54|||||TWO_SIDED|95.0|1.08|2.3||||||||2.30|1.08|
74027817|NCT03849560|147609128|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for YAMA antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Yamagata lineage)|Odds Ratio, log|1.39|||||TWO_SIDED|95.0|0.9|2.15||||||||2.15|0.90|
74027818|NCT03849560|147609128|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for VICT antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.05|||||TWO_SIDED|95.0|0.68|1.63||||||||1.63|0.68|
74027819|NCT03849560|147609129|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H1N1 if the upper limit of the two-sided 95% Confidence Interval (CI) of the ratio of means of geometric antibody titers for H1N1 was ≤1.5|Mean Difference (Final Values)|0.8933|||||TWO_SIDED|95.0|0.7762|1.03||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H1N1||1.030|0.7762|
74027820|NCT03849560|147609129|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H3N2 if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for H3N2 was ≤1.5|Median Difference (Final Values)|0.8913|||||TWO_SIDED|95.0|0.7516|1.0593||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H3N2||1.0593|0.7516|
73861201|NCT01719003|147268534|SUPERIORITY_OR_OTHER||Adjusted mean|-2.5|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.33|-1.68||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.68|-3.33|<0.0001
73861202|NCT01719003|147268534|SUPERIORITY_OR_OTHER||Adjusted Mean|-2.52|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.35|-1.69||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.69|-3.35|<0.0001
73861203|NCT01719003|147268534|SUPERIORITY_OR_OTHER||Adjusted mean|-2.2|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.03|-1.37||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment||-1.37|-3.03|<0.0001
73861204|NCT01719003|147268534|SUPERIORITY_OR_OTHER||Adjusted Mean|-2.26|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.09|-1.43||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.43|-3.09|<0.0001
73861205|NCT01811303|147268556|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
73861206|NCT01811303|147268556|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.016||95.0|||||ANOVA|||||||<0.016
73861207|NCT00320372|147268584|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|38.1|||||TWO_SIDED|95.0|36.3|39.9|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||39.9|36.3|
73861208|NCT00320372|147268584|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|17.0|||||TWO_SIDED|95.0|15.2|19.0|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||19.0|15.2|
73918916|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|2.11|||||TWO_SIDED|95.0|-3.48|7.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 1.||7.70|-3.48|
73918917|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|5.33|||||TWO_SIDED|95.0|-0.41|11.07||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 1.||11.07|-0.41|
73918918|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|2.49|||||TWO_SIDED|95.0|-3.35|8.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 1.||8.33|-3.35|
73918919|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-6.11|5.36||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 2.||5.36|-6.11|
73918920|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|4.36|||||TWO_SIDED|95.0|-1.57|10.29||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 2.||10.29|-1.57|
73918921|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|4.6|||||TWO_SIDED|95.0|-1.45|10.65||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 2.||10.65|-1.45|
73918922|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|-4.25|||||TWO_SIDED|95.0|-10.44|1.93||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 7.||1.93|-10.44|
73918923|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|-0.45|||||TWO_SIDED|95.0|-7.22|6.32||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 7.||6.32|-7.22|
73918924|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|-1.46|||||TWO_SIDED|95.0|-8.25|5.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 7.||5.33|-8.25|
73918925|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-5.98|6.29||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 8.||6.29|-5.98|
73918926|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|8.3|||||TWO_SIDED|95.0|1.52|15.08||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 8.||15.08|1.52|
73861209|NCT00320372|147268584|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||||<.0001
73861210|NCT00320372|147268585|SUPERIORITY_OR_OTHER|||||||0.1015|TWO_SIDED|||||Comparison for Kaplan Meier Median Time until recurrence|Log Rank|Null hypothesis: median TUR between 2 groups is not different. Alternate hypothesis: median TUR between 2 groups is different.||||||0.1015
73861211|NCT00320372|147268586|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|19.8|||||TWO_SIDED|95.0|18.4|21.3|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.||21.3|18.4|
73861212|NCT00320372|147268586|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|8.1|||||TWO_SIDED|95.0|6.9|9.5|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.||9.5|6.9|
73861213|NCT00320372|147268586|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||||<.0001
73861214|NCT00320372|147268592|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.34997|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<0.0001
73861215|NCT00320372|147268593|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||3 Month Time point||||<.0001
73861216|NCT00320372|147268593|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||6 Month Time point||||.0068
73861217|NCT00320372|147268593|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||9 Month Time point||||.0008
73861218|NCT00320372|147268593|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||12 Month Time point||||.0003
73861219|NCT00320372|147268593|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||18 Month Time point||||<.0001
73861220|NCT00320372|147268593|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||24 Month Time point||||.0059
73861221|NCT00320372|147268593|SUPERIORITY_OR_OTHER|||||||0.0028|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||30 Month Time point||||.0028
73861222|NCT00320372|147268593|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||36 Month Time point||||.0002
73861223|NCT00320372|147268593|SUPERIORITY_OR_OTHER|||||||0.0051|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||42 Month Time point||||.0051
73861224|NCT00320372|147268593|SUPERIORITY_OR_OTHER|||||||0.0363|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||48 Month Time point||||.0363
73861225|NCT00320372|147268593|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||54 Month Time point||||.0048
73918927|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|3.82|||||TWO_SIDED|95.0|-2.85|10.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 8.||10.50|-2.85|
73918928|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|-1.09|||||TWO_SIDED|95.0|-7.16|4.97||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 14.||4.97|-7.16|
73918929|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|6.78|||||TWO_SIDED|95.0|-0.11|13.66||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 14.||13.66|-0.11|
73918930|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|3.29|||||TWO_SIDED|95.0|-3.58|10.15||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 14.||10.15|-3.58|
73918931|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|-1.12|||||TWO_SIDED|95.0|-7.64|5.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 15.||5.40|-7.64|
73918932|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|3.59|||||TWO_SIDED|95.0|-3.71|10.89||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 15.||10.89|-3.71|
73918933|NCT00372112|147365854|SUPERIORITY||Mean Difference (Net)|2.11|||||TWO_SIDED|95.0|-4.96|9.18||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 15.||9.18|-4.96|
73918934|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|2.1|||||TWO_SIDED|95.0|-7.7|12.0||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 1.||12.0|-7.7|
73918935|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-7.2|13.1||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 1.||13.1|-7.2|
73918936|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-10.2|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 1.||10.1|-10.2|
73918937|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|2.2|||||TWO_SIDED|95.0|-6.1|10.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 2.||10.4|-6.1|
73918938|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|5.8|||||TWO_SIDED|95.0|-2.8|14.3||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 2.||14.3|-2.8|
73918939|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-6.9|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 2.||10.1|-6.9|
74027821|NCT03849560|147609129|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) vaccine for the strain B/Yamagata if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Yamagata antigen was ≤1|Mean Difference (Final Values)|0.8185|||||TWO_SIDED|95.0|0.6918|0.9683||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) for the strain B/Yamagata||0.9683|0.6918|
73918940|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|-4.9|||||TWO_SIDED|95.0|-16.1|6.2||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 7.||6.2|-16.1|
73918941|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-14.0|10.2||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 7.||10.2|-14.0|
73918942|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|-4.8|||||TWO_SIDED|95.0|-17.1|7.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 7.||7.5|-17.1|
73918943|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|3.4|||||TWO_SIDED|95.0|-4.1|10.9||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 8.||10.9|-4.1|
73918944|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|10.8|||||TWO_SIDED|95.0|2.6|19.0||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 8.||19.0|2.6|
73918945|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|3.1|||||TWO_SIDED|95.0|-5.2|11.4||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 8.||11.4|-5.2|
73918946|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|-7.2|||||TWO_SIDED|95.0|-17.0|2.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 14.||2.7|-17.0|
73918947|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|5.4|||||TWO_SIDED|95.0|-6.0|16.8||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 14.||16.8|-6.0|
73918948|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|-2.9|||||TWO_SIDED|95.0|-13.8|8.0||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 14.||8.0|-13.8|
73918949|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-7.8|8.3||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 15.||8.3|-7.8|
73918950|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|6.8|||||TWO_SIDED|95.0|-2.1|15.6||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 15.||15.6|-2.1|
73918951|NCT00372112|147365856|SUPERIORITY||Mean Difference (Net)|4.4|||||TWO_SIDED|95.0|-4.5|13.3||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 15.||13.3|-4.5|
73918952|NCT00372112|147365871|SUPERIORITY||Mean Difference (Net)|0.1131|||||TWO_SIDED|95.0|-0.0031|0.2293|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 1.||0.2293|-0.0031|
73918953|NCT00372112|147365871|SUPERIORITY||Mean Difference (Net)|0.159|||||TWO_SIDED|95.0|0.0408|0.2771|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 1.||0.2771|0.0408|
73918954|NCT00372112|147365871|SUPERIORITY||Mean Difference (Net)|0.0764|||||TWO_SIDED|95.0|-0.0375|0.1903|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 1.||0.1903|-0.0375|
73918955|NCT00372112|147365871|SUPERIORITY||Mean Difference (Net)|0.1741|||||TWO_SIDED|95.0|0.0178|0.3305|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 7.||0.3305|0.0178|
73918956|NCT00372112|147365871|SUPERIORITY||Mean Difference (Net)|0.1713|||||TWO_SIDED|95.0|0.006|0.3365|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 7.||0.3365|0.0060|
73861226|NCT00320372|147268593|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||60 Month Time point||||.0009
73861227|NCT00320372|147268593|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|12.1009|||||TWO_SIDED|95.0|10.8979|13.3039|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||13.3039|10.8979|
73861228|NCT00320372|147268593|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|7.5964|||||TWO_SIDED|95.0|6.1327|9.0602|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||9.0602|6.1327|
73861229|NCT00320372|147268593|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||||<.0001
73861230|NCT00320372|147268594|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.14837|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<.0001
73861231|NCT00320372|147268595|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.14819|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture.~Alternate hypothesis: There is no correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<.0001
73861232|NCT00320372|147268596|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.04625||||0.0012|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||.0012
73861233|NCT02068118|147268599|SUPERIORITY||rate ratio|0.97|||=|0.8|TWO_SIDED|95.0|0.77|1.23|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||1.23|0.77|=0.80
73861234|NCT02068118|147268600|SUPERIORITY||rate ratio|0.82|||=|0.18|TWO_SIDED|95.0|0.62|1.1|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||1.10|0.62|=0.18
73861235|NCT02068118|147268601|SUPERIORITY||rate ratio|0.6|||=|0.02|TWO_SIDED|95.0|0.39|0.92|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||0.92|0.39|=0.02
73861236|NCT02068118|147268602|SUPERIORITY||||||=|0.68|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.68
73861237|NCT02068118|147268604|SUPERIORITY||||||=|0.85|||||||Log Rank|||Time to death from any cause compared using the log-rank test||||=0.85
73861238|NCT02068118|147268605|SUPERIORITY||rate ratio|0.97|||=|0.77|TWO_SIDED|95.0|0.78|1.21|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).||1.21|0.78|=0.77
73861239|NCT02068118|147268606|SUPERIORITY||rate ratio|0.97|||=|0.83|TWO_SIDED|95.0|0.74|1.27|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths from cardiovascular cause that occurred during a hospitalization for cardiovascular cause with an overnight stay were counted as two events."||1.27|0.74|=0.83
73861240|NCT02068118|147268607|SUPERIORITY||rate ratio|0.84|||=|0.28|TWO_SIDED|95.0|0.62|1.15|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||1.15|0.62|=0.28
73861241|NCT02068118|147268608|SUPERIORITY||rate ratio|0.71|||=|0.078|TWO_SIDED|95.0|0.48|1.04|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||1.04|0.48|=0.078
73918957|NCT00372112|147365871|SUPERIORITY||Mean Difference (Net)|0.1377|||||TWO_SIDED|95.0|-0.0233|0.2987|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 7.||0.2987|-0.0233|
73918958|NCT00372112|147365871|SUPERIORITY||Mean Difference (Net)|0.139|||||TWO_SIDED|95.0|-0.0266|0.3046|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 14.||0.3046|-0.0266|
73918959|NCT00372112|147365871|SUPERIORITY||Mean Difference (Net)|0.1906|||||TWO_SIDED|95.0|0.0177|0.3635|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 14.||0.3635|0.0177|
73918960|NCT00372112|147365871|SUPERIORITY||Mean Difference (Net)|0.0956|||||TWO_SIDED|95.0|-0.0686|0.2599|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 14.||0.2599|-0.0686|
73918961|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.009|||||TWO_SIDED|95.0|-0.59|0.608|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 1.||0.608|-0.590|
73918962|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.237|||||TWO_SIDED|95.0|-0.354|0.829|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 1.||0.829|-0.354|
73918963|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.093|||||TWO_SIDED|95.0|-0.469|0.654|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 1.||0.654|-0.469|
73918964|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.199|||||TWO_SIDED|95.0|-0.591|0.988|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 2.||0.988|-0.591|
73918965|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.633|||||TWO_SIDED|95.0|-0.152|1.418|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 2.||1.418|-0.152|
73918966|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.065|||||TWO_SIDED|95.0|-0.667|0.797|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 2.||0.797|-0.667|
73966842|NCT04521478|147470544|OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|2.4||0.7395|TWO_SIDED|90.0|-3.2|4.8|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.8|-3.2|0.7395
73966843|NCT04521478|147470544|OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|2.4||0.6296|TWO_SIDED|90.0|-2.7|5.0|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.0|-2.7|0.6296
73966844|NCT04521478|147470544|OTHER||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|1.9||0.0429|TWO_SIDED|90.0|0.7|6.9|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.9|0.7|0.0429
73966845|NCT04521478|147470545|OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6211|TWO_SIDED|90.0|-0.3|0.5|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.5|-0.3|0.6211
73918967|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.097|||||TWO_SIDED|95.0|-0.476|0.67|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 7.||0.670|-0.476|
73918968|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.408|||||TWO_SIDED|95.0|-0.208|1.024|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 7.||1.024|-0.208|
73918969|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.471|0.631|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 7.||0.631|-0.471|
73918970|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.245|||||TWO_SIDED|95.0|-0.66|1.149|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 8.||1.149|-0.660|
73918971|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.796|||||TWO_SIDED|95.0|-0.174|1.766|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 8.||1.766|-0.174|
73918972|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.144|||||TWO_SIDED|95.0|-0.742|1.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 8.||1.030|-0.742|
73918973|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.056|||||TWO_SIDED|95.0|-0.556|0.669|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 14.||0.669|-0.556|
73918974|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.138|||||TWO_SIDED|95.0|-0.767|0.491|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 14.||0.491|-0.767|
73918975|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.187|||||TWO_SIDED|95.0|-0.765|0.391|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 14.||0.391|-0.765|
73918976|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.094|||||TWO_SIDED|95.0|-0.619|0.806|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 15.||0.806|-0.619|
73918977|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.358|||||TWO_SIDED|95.0|-0.39|1.105|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 15.||1.105|-0.390|
73918978|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.178|||||TWO_SIDED|95.0|-0.522|0.877|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 15.||0.877|-0.522|
73966846|NCT04521478|147470545|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.5158|TWO_SIDED|90.0|-0.2|0.6|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.2|0.5158
73918979|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.294|||||TWO_SIDED|95.0|-0.586|-0.001|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 1.||-0.001|-0.586|
73918980|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.371|||||TWO_SIDED|95.0|-0.657|-0.085|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 1.||-0.085|-0.657|
74027822|NCT03849560|147609129|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Victoria lineage) vaccine for the strain B/Victoria if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Victoria antigen was ≤1|Mean Difference (Final Values)|1.0328||||0.05|TWO_SIDED|95.0|0.857|1.2445|||ANCOVA|||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Victoria lineage) for the strain B/Victoria||1.2445|0.8570|0.05
74027823|NCT03849560|147609130|NON_INFERIORITY|Seroprotection for strain A/H1N1 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups||||||0.758|||||||Fisher Exact|||||||0.758
74027824|NCT03849560|147609130|NON_INFERIORITY|Seroprotection for strain A/H3N2 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups||||||0.282|||||||Fisher Exact|||||||0.282
74027825|NCT03849560|147609130|NON_INFERIORITY|Seroprotection for strain B/Yamagata in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage) group||||||0.352|||||||Fisher Exact|||||||0.352
74027826|NCT03849560|147609130|NON_INFERIORITY|Seroprotection for strain B/Victoria in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Victoria lineage) group||||||0.815|||||||Fisher Exact|||||||0.815
73918981|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.153|||||TWO_SIDED|95.0|-0.44|0.133|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 1.||0.133|-0.440|
73918982|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.216|||||TWO_SIDED|95.0|-0.679|0.247|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 2.||0.247|-0.679|
73918983|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.536|||||TWO_SIDED|95.0|-0.998|-0.074|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 2.||-0.074|-0.998|
73918984|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.018|||||TWO_SIDED|95.0|-0.452|0.416|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 2.||0.416|-0.452|
73918985|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.486|||||TWO_SIDED|95.0|-0.878|-0.095|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 7.||-0.095|-0.878|
73918986|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.562|||||TWO_SIDED|95.0|-0.99|-0.135|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 7.||-0.135|-0.990|
74027827|NCT03849560|147609131|OTHER|||||||0.452|||||||Log Rank|||||||0.452
74027828|NCT03849560|147609131|OTHER|||||||0.639|||||||Log Rank|||||||0.639
73918987|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.575|0.196|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 7.||0.196|-0.575|
73918988|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.075|||||TWO_SIDED|95.0|-0.235|0.385|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 8.||0.385|-0.235|
73918989|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.275|||||TWO_SIDED|95.0|-0.623|0.073|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 8.||0.073|-0.623|
73918990|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.103|||||TWO_SIDED|95.0|-0.213|0.418|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 8.||0.418|-0.213|
73918991|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.299|||||TWO_SIDED|95.0|-0.64|0.042|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 14.||0.042|-0.640|
73918992|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.271|||||TWO_SIDED|95.0|-0.621|0.079|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 14.||0.079|-0.621|
73918993|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.095|||||TWO_SIDED|95.0|-0.432|0.243|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 14.||0.243|-0.432|
73918994|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.173|||||TWO_SIDED|95.0|-0.158|0.505|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 15.||0.505|-0.158|
73918995|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.196|||||TWO_SIDED|95.0|-0.535|0.143|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 15.||0.143|-0.535|
73918996|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.139|||||TWO_SIDED|95.0|-0.198|0.475|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 15.||0.475|-0.198|
73918997|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-1.18|0.9|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 1.||0.90|-1.18|
73918998|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.29|||||TWO_SIDED|95.0|-0.72|1.3|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 1.||1.30|-0.72|
73918999|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.17|||||TWO_SIDED|95.0|-1.15|0.8|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 1.||0.80|-1.15|
73919000|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.64|1.44|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 2.||1.44|-0.64|
73919001|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|-0.32|1.7|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 2.||1.70|-0.32|
73919002|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.74|1.2|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 2.||1.20|-0.74|
73919003|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-1.11|1.01|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 7.||1.01|-1.11|
73919004|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.53|||||TWO_SIDED|95.0|-0.57|1.62|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 7.||1.62|-0.57|
73919005|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.89|1.15|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 7.||1.15|-0.89|
73919006|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|-0.98|1.5|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 8.||1.50|-0.98|
73919007|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.86|||||TWO_SIDED|95.0|-0.42|2.14|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 8.||2.14|-0.42|
73919008|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|-0.9|1.54|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 8.||1.54|-0.90|
73919009|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-1.2|1.3|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 14.||1.30|-1.20|
73966847|NCT04521478|147470545|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4518|TWO_SIDED|90.0|-0.2|0.6|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.2|0.4518
74027829|NCT03849560|147609133|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of mean geometri|4.86|||||TWO_SIDED|95.0|4.22|5.6||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Quadri group||5.60|4.22|
73861242|NCT02068118|147268609|SUPERIORITY||rate ratio|0.5|||=|0.023|TWO_SIDED|95.0|0.28|0.91|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||0.91|0.28|=0.023
73861243|NCT02068118|147268610|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.044|TWO_SIDED|95.0|0.62|0.99|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.99|0.62|=0.044
73861244|NCT02068118|147268611|SUPERIORITY||Adjusted Means Difference|1.06|||=|0.17|TWO_SIDED|95.0|-2.48|4.61||Study group effect over time|Mixed Models Analysis|||ANCOVA Physical Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with physical functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.61|-2.48|=0.17
74027830|NCT03849560|147609133|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.32|||||TWO_SIDED|95.0|4.53|6.24||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Quadri group||6.24|4.53|
74027831|NCT03849560|147609133|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5|Coefficient of increase of GMT|5.47|||||TWO_SIDED|95.0|4.78|6.25||||||Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Quadri group||6.25|4.78|
74027832|NCT03849560|147609133|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5|Coefficient of increase of GMT|4.77|||||TWO_SIDED|95.0|4.14|5.49||||||Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Quadri group||5.49|4.14|
73861245|NCT02068118|147268611|SUPERIORITY||Adjusted Means Difference|1.8|||=|0.23|TWO_SIDED|95.0|-2.61|6.21||Study group effect over time|Mixed Models Analysis|||ANCOVA Role Physical score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role physical score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||6.21|-2.61|=0.23
73861246|NCT02068118|147268611|SUPERIORITY||Adjusted Means Difference|4.46|||=|0.5|TWO_SIDED|95.0|0.59|8.33||Study group effect over time|Mixed Models Analysis|||ANCOVA Bodily Pain score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with bodily pain score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||8.33|0.59|=0.50
73861247|NCT02068118|147268611|SUPERIORITY||Adjusted Means Difference|2.52|||=|0.19|TWO_SIDED|95.0|-0.07|5.12||Study group effect over time|Mixed Models Analysis|||ANCOVA General Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with general health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||5.12|-0.07|=0.19
73861248|NCT02068118|147268611|SUPERIORITY||Adjusted Means Difference|2.38|||=|0.034|TWO_SIDED|95.0|-0.09|4.85||Study group effect over time|Mixed Models Analysis|||ANCOVA Vitality score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with vitality score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.85|-0.09|=0.034
73861249|NCT02068118|147268611|SUPERIORITY||Adjusted Means Difference|4.03|||=|0.025|TWO_SIDED|95.0|0.6|7.47||Study group effect over time|Mixed Models Analysis|||ANCOVA Social Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with social functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||7.47|0.60|=0.025
73861250|NCT02068118|147268611|SUPERIORITY||Adjusted Means Difference|1.01|||=|0.9|TWO_SIDED|95.0|-2.79|4.81||Study group effect over time|Mixed Models Analysis|||ANCOVA Role Emotional score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role emotional score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.81|-2.79|=0.90
73861251|NCT02068118|147268611|SUPERIORITY||Adjusted Means Difference|2.26|||=|0.19|TWO_SIDED|95.0|0.16|4.37||Study group effect over time|Mixed Models Analysis|||ANCOVA Mental Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with mental health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.37|0.16|=0.19
73861252|NCT02068118|147268611|SUPERIORITY||Adjusted Means Difference|0.9|||=|0.26|TWO_SIDED|95.0|-0.48|2.28||Study group effect over time|Mixed Models Analysis|||ANCOVA Physical Component Summary (PCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with PCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||2.28|-0.48|=0.26
73861253|NCT02068118|147268611|SUPERIORITY||Adjusted Means Difference|1.2|||=|0.17|TWO_SIDED|95.0|0.08|2.31||Study group effect over time|Mixed Models Analysis|||ANCOVA Mental Component Summary (MCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with MCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||2.31|0.08|=0.17
73861254|NCT02068118|147268616|SUPERIORITY||||||=|0.03|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.03
73861255|NCT02068118|147268617|SUPERIORITY||||||=|0.15|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.15
73861256|NCT02068118|147268618|SUPERIORITY||Hazard Ratio (HR)|0.71|||=|0.02|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.95|0.53|=0.02
73861257|NCT02068118|147268619|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.043|TWO_SIDED|95.0|0.39|0.98|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.98|0.39|=0.043
73861258|NCT01996592|147268627|OTHER||||||<|0.01||||||p-value was calculated|ANOVA|||"PROMIS -perceived stress scale was utilized (a validated test). Scoring ranges from 0-40, with the following ranges indicative of low, moderate, or high perceived stress:~0-13=low stress 14-26=moderate stress 27-40=high perceived stress"||||<0.01
73861259|NCT01996592|147268628|OTHER||||||<|0.01||||||p-value was calculated|ANOVA|||||||<0.01
73861260|NCT00394901|147268629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.262||95.0|-0.85|0.23|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.23|-0.85|0.262
73861261|NCT00394901|147268629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.002||95.0|-1.39|-0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.32|-1.39|0.002
73861262|NCT00394901|147268629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.019||95.0|-1.15|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.15|0.019
73861263|NCT00394901|147268630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.016||95.0|-1.16|-0.12|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.12|-1.16|0.016
73861264|NCT00394901|147268630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.008||95.0|-1.14|-0.17|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.14|0.008
73861265|NCT00394901|147268631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.1160
73861266|NCT00394901|147268631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0015||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0015
73919010|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|-0.53|2.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 14.||2.03|-0.53|
73861267|NCT00394901|147268631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0107||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0107
73861268|NCT00394901|147268632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51||||0.038||95.0|-0.99|-0.03|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.03|-0.99|0.038
73861269|NCT00394901|147268632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.27|-1.22|0.002
73861270|NCT00394901|147268632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.002||95.0|-1.19|-0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.19|0.002
73861271|NCT00394901|147268633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.048||95.0|-0.97|0.0|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.00|-0.97|0.048
73861272|NCT00394901|147268633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.47|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.47|<0.001
73861273|NCT00394901|147268633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03|||<|0.001||95.0|-1.49|-0.56|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.49|<0.001
73861274|NCT00394901|147268634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.096||95.0|-0.89|0.07|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.07|-0.89|0.096
73861275|NCT00394901|147268634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||<|0.001||95.0|-1.44|-0.48|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.48|-1.44|<0.001
73919011|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-1.23|1.23|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 14.||1.23|-1.23|
73919012|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.22|||||TWO_SIDED|95.0|-0.78|1.23|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 15.||1.23|-0.78|
73919013|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.84|||||TWO_SIDED|95.0|-0.21|1.89|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 15.||1.89|-0.21|
73919014|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.49|||||TWO_SIDED|95.0|-0.5|1.48|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 15.||1.48|-0.50|
73919015|NCT00372112|147365876|SUPERIORITY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.47|0.09|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 1.||0.09|-0.47|
73919016|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.49|0.04|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 1.||0.04|-0.49|
73919017|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.46|0.07|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 1.||0.07|-0.46|
73919018|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.47|0.27|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 2.||0.27|-0.47|
73919019|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.73|-0.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 2.||-0.03|-0.73|
73919020|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.37|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 2.||0.34|-0.37|
73919021|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.54|||||TWO_SIDED|95.0|-0.97|-0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 7.||-0.12|-0.97|
73919022|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.55|||||TWO_SIDED|95.0|-0.98|-0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 7.||-0.12|-0.98|
73919023|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.76|0.08|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 7.||0.08|-0.76|
73919024|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.26|0.33|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 8.||0.33|-0.26|
73919025|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-0.7|-0.1|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 8.||-0.10|-0.70|
73919026|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 8.||0.34|-0.26|
73919027|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.42|0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 14.||0.12|-0.42|
73919028|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.51|0.04|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 14.||0.04|-0.51|
73919029|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.34|0.21|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 14.||0.21|-0.34|
73919030|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.25|0.35|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 15.||0.35|-0.25|
73919031|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.66|-0.05|||Regression, Linear|||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 15.||-0.05|-0.66|
74027833|NCT03849560|147609133|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of GMT|4.21|||||TWO_SIDED|95.0|3.59|4.94||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Yamagata lineage) group||4.94|3.59|
74027834|NCT03849560|147609133|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.22|||||TWO_SIDED|95.0|4.45|6.12||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Yamagata lineage) group||6.12|4.45|
74027835|NCT03849560|147609133|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5|Coefficient of increase of GMT|4.04|||||TWO_SIDED|95.0|3.48|4.69||||||Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Plus, trivalent (Yamagata lineage) group||4.69|3.48|
74027836|NCT03849560|147609133|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of GMT|4.6|||||TWO_SIDED|95.0|3.97|5.34||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Victoria lineage) group||5.34|3.97|
74027837|NCT03849560|147609133|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.17|||||TWO_SIDED|95.0|4.38|6.12||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Victoria lineage) group||6.12|4.38|
74027838|NCT03849560|147609133|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5|Coefficient of increase of GMT|4.72|||||TWO_SIDED|95.0|4.0|5.56||||||Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Plus, trivalent (Victoria lineage) group||5.56|4.00|
74027839|NCT01633060|147609150|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.67|||<|0.001|ONE_SIDED|95.0|0.53||||Log Rank||||||0.53|<0.001
74086581|NCT04100096|147726638|SUPERIORITY||LS Mean Difference|-0.3||||0.0638|TWO_SIDED|95.0|-0.61|0.02||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 8||0.02|-0.61|0.0638
73861276|NCT00394901|147268634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.46|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.46|<0.001
73861277|NCT00394901|147268635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55||||0.505||95.0|-2.16|1.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.06|-2.16|0.505
73861278|NCT00394901|147268635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.86||||0.023||95.0|-3.46|-0.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-3.46|0.023
74027840|NCT00553787|147609194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|0.328|<|0.0001|TWO_SIDED|95.0|7.96|9.25||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||9.25|7.96|<0.0001
74027841|NCT00553787|147609194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.58|STANDARD_ERROR_OF_MEAN|0.403|<|0.0001|TWO_SIDED|95.0|5.79|7.37||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||7.37|5.79|<0.0001
74027842|NCT00553787|147609194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|STANDARD_ERROR_OF_MEAN|0.402|<|0.0001|TWO_SIDED|95.0|1.24|2.82||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||2.82|1.24|<0.0001
74027843|NCT00553787|147609195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.03|STANDARD_ERROR_OF_MEAN|0.955|<|0.0001|TWO_SIDED|95.0|7.34|11.11||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||11.11|7.34|<0.0001
74027844|NCT00553787|147609195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.27|STANDARD_ERROR_OF_MEAN|0.768|<|0.0001|TWO_SIDED|95.0|4.93|7.97||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||7.97|4.93|<0.0001
73919032|NCT00372112|147365876|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 15.||0.34|-0.26|
73919033|NCT01025791|147365891|OTHER||0.1 mg vs. placebo|-7.06||||0.003|TWO_SIDED|90.0|-11.1|-3.0|||ANOVA|||||-3.00|-11.1|0.003
73966848|NCT04521478|147470545|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2347|TWO_SIDED|90.0|-0.1|0.6|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.1|0.2347
73966849|NCT04521478|147470546|OTHER||Mean Difference (Net)|3.4|STANDARD_ERROR_OF_MEAN|2.5||0.1723|TWO_SIDED|90.0|-0.7|7.6|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||7.6|-0.7|0.1723
73966850|NCT04521478|147470546|OTHER||Mean Difference (Net)|4.4|STANDARD_ERROR_OF_MEAN|2.5||0.0757|TWO_SIDED|90.0|0.3|8.5|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.5|0.3|0.0757
73966851|NCT04521478|147470546|OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.4||0.6864|TWO_SIDED|90.0|-3.0|5.0|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.0|-3.0|0.6864
73966852|NCT04521478|147470546|OTHER||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|1.9||0.1585|TWO_SIDED|90.0|-0.5|6.0|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.0|-0.5|0.1585
73966853|NCT05161715|147470547|OTHER|||||||0.425||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.425
74027845|NCT00553787|147609195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.169||0.0018|TWO_SIDED|95.0|1.15|1.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||1.81|1.15|0.0018
73919034|NCT01025791|147365891|OTHER||0.2 mg vs. placebo|-1.23||||0.31|TWO_SIDED|90.0|-5.42|2.96|||ANOVA|||||2.96|-5.42|0.310
73919035|NCT01025791|147365891|OTHER||0.5 mg vs. placebo|0.01||||0.498|TWO_SIDED|90.0|-4.05|4.06|||ANOVA|||||4.06|-4.05|0.498
73966854|NCT05161715|147470548|OTHER|||||||0.0002||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.0002
73966855|NCT05161715|147470549|OTHER|||||||0.0424||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.0424
73966856|NCT05161715|147470550|OTHER|||||||0.001||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.001
73966857|NCT05161715|147470555|OTHER|||||||0.556||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.556
73966858|NCT03775109|147470556|SUPERIORITY||Mean Difference (Net)|16.7||||0.248|TWO_SIDED|95.0|-11.2|44.5||The threshold for statistical significance was p = 0.05|Chi-squared||Difference = Canakinumab - Placebo|It is estimated that improvement of histological alcoholic steatohepatitis will occur in 40% of patients treated with placebo and 80% of patients treated with Canakinumab. A trial with 80% power to detect a difference at the P \< 0.05 threshold would require 23 patients in each arm, 46 in total. Assuming a drop-out rate of 10%, we will recruit 52 patients in total (26 patients per group).||44.5|-11.2|0.248
74027846|NCT02708212|147609198|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of fentanyl and midazolam between the two study groups.||||<0.0001
74027847|NCT02708212|147609199|SUPERIORITY_OR_OTHER|||||||0.0012|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of midazolam between the two study groups.||||0.0012
74027848|NCT02708212|147609200|SUPERIORITY_OR_OTHER|||||||0.6967|||||||t-test, 2 sided|||||||0.6967
74027849|NCT05341466|147609201|SUPERIORITY||Mean Difference (Net)|0.528|STANDARD_ERROR_OF_MEAN|0.188||0.0098|||||||Mixed Models Analysis|||||||0.0098
74027850|NCT05341466|147609201|OTHER||Adjusted R-squared|0.418||||0.014|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus step length asymmetry.||||0.014
74027851|NCT05341466|147609201|OTHER||Adjusted R-squared|0.496||||0.006|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus step time asymmetry.||||0.006
74027852|NCT05341466|147609201|OTHER||Adjusted R-squared|0.666||||0.001|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus changes in net metabolic power.||||0.001
73919036|NCT01025791|147365891|OTHER||1 mg vs. placebo|-5.69||||0.012|TWO_SIDED|90.0|-9.74|-1.63|||ANOVA|||||-1.63|-9.74|0.012
73919037|NCT01025791|147365891|OTHER||1 mg + 0.8 mg vs. placebo|-3.97||||0.059|TWO_SIDED|90.0|-8.16|0.22|||ANOVA|||||0.22|-8.16|0.059
73919038|NCT01025791|147365891|OTHER||0.4 mg vs. placebo|2.22||||0.191|TWO_SIDED|90.0|-2.09|6.54|||ANOVA|||||6.54|-2.09|0.191
73919039|NCT01025791|147365891|OTHER||1.2 mg vs. placebo|1.24||||0.333|TWO_SIDED|90.0|-3.67|6.15|||ANOVA|||||6.15|-3.67|0.333
73919040|NCT01025791|147365891|OTHER||1.2 mg + 0.6 mg vs. placebo|-1.43||||0.314|TWO_SIDED|90.0|-6.5|3.63|||ANOVA|||||3.63|-6.50|0.314
73919041|NCT01025791|147365891|OTHER||1 mg + 0.8 mg vs. placebo|-9.31||||0.001|TWO_SIDED|90.0|-14.2|-4.37|||ANOVA|||||-4.37|-14.2|0.001
73919042|NCT01025791|147365891|OTHER||1.2 mg + 1.0 mg vs. placebo|-6.45||||0.017|TWO_SIDED|90.0|-11.4|-1.51|||ANOVA|||||-1.51|-11.4|0.017
73919043|NCT01025791|147365891|OTHER||1.0 mg + 0.6 mg + 0.6 mg vs. placebo|-9.96||||0.001|TWO_SIDED|90.0|-14.9|-5.02|||ANOVA|||||-5.02|-14.9|0.001
73919044|NCT01025791|147365891|OTHER||1 mg + 1 mg + 0.6 mg vs. placebo|-9.0||||0.002|TWO_SIDED|95.0|-13.8|-4.17|||ANOVA|||||-4.17|-13.8|0.002
73919045|NCT01025791|147365896|OTHER||GMR (Fed/Fasted)|0.89|||||TWO_SIDED|95.0|0.86|0.92||||||||0.92|0.86|
73919046|NCT01025791|147365897|OTHER||GMR (Fed/fasted)|0.97|||||TWO_SIDED|95.0|0.79|1.19||||||||1.19|0.79|
73919047|NCT01025791|147365898|OTHER||0.1 mg vs placebo|-0.53||||0.396|TWO_SIDED|90.0|-3.92|2.86|||ANOVA|||||2.86|-3.92|0.396
73919048|NCT01025791|147365898|OTHER||0.2 mg vs. placebo|2.33||||0.1329|TWO_SIDED|90.0|-1.17|5.83|||ANOVA|||||5.83|-1.17|0.1329
73919049|NCT01025791|147365898|OTHER||0.5mg vs. placebo|-2.96||||0.0741|TWO_SIDED|90.0|-6.35|0.43|||ANOVA|||||0.43|-6.35|0.0741
74086582|NCT04100096|147726638|SUPERIORITY||LS Mean Difference|-0.11||||0.505|TWO_SIDED|95.0|-0.44|0.22||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 10||0.22|-0.44|0.5050
73919050|NCT01025791|147365898|OTHER||1 mg vs. placebo|7.08|||<|0.001|TWO_SIDED|90.0|3.69|10.47|||ANOVA|||||10.47|3.69|<0.001
73919051|NCT01025791|147365898|OTHER||1 mg + 0.8 mg vs. placebo|4.39||||0.0211|TWO_SIDED|90.0|0.89|7.09|||ANOVA|||||7.09|0.89|0.0211
73919052|NCT01025791|147365898|OTHER||0.4 mg vs. placebo|0.85||||0.399|TWO_SIDED|90.0|-4.79|6.48|||ANOVA|||||6.48|-4.79|0.399
73919053|NCT01025791|147365898|OTHER||1.2 mg vs. placebo|4.54||||0.1|TWO_SIDED|90.0|-1.94|11.02|||ANOVA|||||11.02|-1.94|0.100
73919054|NCT01025791|147365898|OTHER||1.2 mg + 0.6 mg vs. placebo|3.38||||0.195|TWO_SIDED|90.0|-3.29|10.06|||ANOVA|||||10.06|-3.29|0.195
73919055|NCT01025791|147365898|OTHER||1.0 mg + 0.8 mg vs. placebo|9.16||||0.022|TWO_SIDED|90.0|1.74|16.58|||ANOVA|||||16.58|1.74|0.022
73919056|NCT01025791|147365898|OTHER||1.2 mg + 1.0 mg vs. placebo|5.74||||0.098|TWO_SIDED|90.0|-1.68|13.16|||ANOVA|||||13.16|-1.68|0.098
73919057|NCT01025791|147365898|OTHER||1 mg + 0.6 mg + 0.6 mg vs. placebo|3.48||||0.214|TWO_SIDED|90.0|-3.94|10.9|||ANOVA|||||10.90|-3.94|0.214
73919058|NCT01025791|147365898|OTHER||1 mg + 1 mg + 0.6 mg vs. placebo|4.24||||0.163|TWO_SIDED|95.0|-3.03|11.52|||ANOVA|||||11.52|-3.03|0.163
73919059|NCT04649060|147365899|SUPERIORITY||Hazard Ratio (HR)|0.184|||=|0.0032|TWO_SIDED|95.0|0.052|0.65|||Log Rank|||||0.650|0.052|=0.0032
73919060|NCT04649060|147365900|SUPERIORITY|||||||0.03|||||||Cochran-Mantel-Haenszel|||||||0.03
73919061|NCT04649060|147365901|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.525|TWO_SIDED|95.0|0.026|6.693|||Log Rank|||||6.693|0.026|0.525
73919062|NCT04649060|147365903|SUPERIORITY|||||||0.0997|||||||Cochran-Mantel-Haenszel|||||||0.0997
73919063|NCT04649060|147365904|SUPERIORITY||Hazard Ratio (HR)|0.111||||0.016|TWO_SIDED|95.0|0.013|0.96|||Log Rank|||||0.960|0.013|0.016
73919064|NCT04649060|147365906|SUPERIORITY||Hazard Ratio (HR)|0.231||||0.0187|TWO_SIDED|95.0|0.063|0.846|||Log Rank|||||0.846|0.063|0.0187
73919065|NCT04649060|147365907|SUPERIORITY||Hazard Ratio (HR)|0.224||||0.0384|TWO_SIDED|95.0|0.047|1.056|||Log Rank|||||1.056|0.047|0.0384
73919066|NCT04649060|147365908|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.3721|TWO_SIDED|95.0|0.086|2.569|||Log Rank|||||2.569|0.086|0.3721
73919067|NCT02730455|147365961|SUPERIORITY||Odds Ratio (OR)|0.64||||0.086|TWO_SIDED|95.0|0.38|1.07|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline National Institute of Health Stroke Scale (NIHSS) category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tissue plasminogen activator (tPA) use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, United States of America \[USA\]) as covariates and unstructured working correlation structure||1.07|0.38|0.086
73919068|NCT02730455|147365961|SUPERIORITY||Odds Ratio (OR)|0.57||||0.031|TWO_SIDED|95.0|0.34|0.95|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||0.95|0.34|0.031
73919069|NCT02730455|147365962|SUPERIORITY||Odds Ratio (OR)|0.67||||0.222|TWO_SIDED|95.0|0.35|1.28|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||1.28|0.35|0.222
73919070|NCT02730455|147365962|SUPERIORITY||Odds Ratio (OR)|0.54||||0.073|TWO_SIDED|95.0|0.28|1.06|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||1.06|0.28|0.073
73966859|NCT03775109|147470557|SUPERIORITY||Mean Difference (Net)|0.043|||||TWO_SIDED|95.0|-0.235|0.322|||||Difference = Canakinumab - Placebo|||0.322|-0.235|
73966860|NCT03775109|147470558|SUPERIORITY||Odds Ratio (OR)|3.133|||||TWO_SIDED|95.0|0.121|81.004||||||||81.004|0.121|
74088426|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3548|STANDARD_ERROR_OF_MEAN|0.2076||0.0917||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever smoked marijuana(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0917
73966861|NCT03775109|147470559|SUPERIORITY||Odds Ratio (OR)|1.887|||||TWO_SIDED|95.0|0.357|9.965||||||||9.965|0.357|
73966862|NCT03775109|147470562|SUPERIORITY|||||||0.27|||||||ANCOVA|Change in log-transformed serum bilirubin from baseline to day 28. 49 participants were included in this analysis.||||||0.270
73966863|NCT03775109|147470563|SUPERIORITY|||||||0.0349|||||||ANCOVA|ANCOVA model: MELD score at Day 28 = intercept + treatment group indicator + baseline MELD score. 49 patients have data at Day 28 and baseline.||||||0.03490
73966864|NCT03775109|147470564|SUPERIORITY||Odds Ratio (OR)|5.088|||||TWO_SIDED|95.0|1.558|16.624|||||Ordinal logistic regression (proportional odds) model. GAHS at day 28 = intercept + treatment group indicator + baseline GAHS measurement. 48 participants have GAHS data at baseline and day 28.|||16.624|1.558|
73966865|NCT03775109|147470565|SUPERIORITY|||||||0.343|||||||ANCOVA|ANCOVA model: mDF score at day 28 = intercept + treatment group indicator + baseline mDF score.||Natural log transformation used for both baseline and day 28 measurements. 49 participants have mDF measurements at baseline and day 28.||||0.343
73966866|NCT03775109|147470566|SUPERIORITY||Mean Difference (Net)|0.083|||||TWO_SIDED|95.0|-0.529|0.696|||||difference = canakinumab - placebo. natural log transformation used.|||0.696|-0.529|
73966867|NCT03775109|147470567|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73966868|NCT03775109|147470568|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73966869|NCT03775109|147470569|SUPERIORITY||Cox Proportional Hazard|1.046|||||TWO_SIDED|95.0|0.147|7.424||||||||7.424|0.147|
74027853|NCT05341466|147609202|SUPERIORITY||Median Difference (Net)|-0.0042|STANDARD_DEVIATION|0.0232||0.744|||||||ANOVA|||||||0.744
74027854|NCT05341466|147609203|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.0231||0.269|||||||ANOVA|||||||0.269
74027855|NCT05341466|147609204|SUPERIORITY||Median Difference (Net)|-0.4|STANDARD_DEVIATION|0.681||0.02|||||||ANOVA|||||||0.020
73966870|NCT03775109|147470577|SUPERIORITY||Mean Difference (Net)|0.043|||||TWO_SIDED|95.0|-0.235|0.322|||||Difference = Canakinumab - Placebo|||0.322|-0.235|
73966871|NCT03775109|147470578|SUPERIORITY||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.388|0.127|||||Difference = Canakinumab - Placebo|||0.127|-0.388|
73966872|NCT03775109|147470579|SUPERIORITY||Odds Ratio (OR)|4.012|||||TWO_SIDED|95.0|0.693|23.219||||||||23.219|0.693|
73966873|NCT03775109|147470580|SUPERIORITY||Odds Ratio (OR)|4.543|||||TWO_SIDED|95.0|0.543|38.043||||||||38.043|0.543|
73966874|NCT03775109|147470581|SUPERIORITY||Odds Ratio (OR)|1.745|||||TWO_SIDED|95.0|0.456|6.558||||||||6.558|0.456|
73966875|NCT03775109|147470582|SUPERIORITY||Odds Ratio (OR)|0.977|||||TWO_SIDED|95.0|0.281|3.397||||||||3.397|0.281|
73966876|NCT03775109|147470583|SUPERIORITY||Odds Ratio (OR)|0.768|||||TWO_SIDED|95.0|0.238|2.479||||||||2.479|0.238|
73966877|NCT04690673|147470596|EQUIVALENCE|Based on previous reports on the pharmacokinetics of oral paracetamol, the standard deviation of the within-subject difference in the Cmax for paracetamol was estimated to be 35% of the mean Cmax. Using this standard deviation, 10 participants were estimated to be sufficient, with a power of at least 80% (at 5% significance level). We recruited 12 volunteers to account for potential protocol violations or dropouts.|Geometric mean ratio|1.03||||0.05|TWO_SIDED|90.0|0.94|1.13||Not adjusted for multiple comparisons as the analysis was exploratory|t-test, 2 sided||Adhering|Highest paracetamol concentrations (Cmax) measured from capillary with the electrochemical method compared with measurements with mass-spectrometry.||1.13|0.94|0.05
73966878|NCT03743636|147470598|SUPERIORITY||Mean Difference (Final Values)|17.57||||0.0775|ONE_SIDED|90.0|1.77||||Mixed Models Analysis||||||1.77|0.0775
73966879|NCT03743636|147470599|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.3762|ONE_SIDED|90.0|-11.24||||Mixed Models Analysis||||||-11.24|0.3762
73966880|NCT03743636|147470600|SUPERIORITY||Mean Difference (Final Values)|22.42||||0.0294|ONE_SIDED|90.0|7.31||||Mixed Models Analysis||||||7.31|0.0294
73966881|NCT03743636|147470601|SUPERIORITY||Mean Difference (Final Values)|20.63||||0.0336|ONE_SIDED|90.0|6.26||||Mixed Models Analysis||||||6.26|0.0336
73966882|NCT03743636|147470602|SUPERIORITY||Mean Difference (Final Values)|-1.78||||0.562|ONE_SIDED|90.0|-16.51||||Mixed Models Analysis||||||-16.51|0.5620
73966883|NCT03743636|147470603|SUPERIORITY||Mean Difference (Final Values)|-13.93||||0.8797|ONE_SIDED|90.0|-29.15||||Mixed Models Analysis||||||-29.15|0.8797
73966884|NCT03743636|147470604|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0752|ONE_SIDED|90.0|0.24||||ANCOVA||||||0.24|0.0752
73966885|NCT03743636|147470605|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.8703|ONE_SIDED|90.0|-15.19||||ANCOVA||||||-15.19|0.8703
73966886|NCT03743636|147470606|SUPERIORITY||Mean Difference (Final Values)|10995.0||||0.1402|ONE_SIDED|90.0|-2078.0||||ANCOVA||||||-2078|0.1402
73966887|NCT03743636|147470607|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.1249|ONE_SIDED|90.0|-0.21||||ANCOVA||||||-0.21|0.1249
73966888|NCT03743636|147470608|SUPERIORITY||Mean Difference (Final Values)|-5.05||||0.8039|ONE_SIDED|90.0|-12.62||||ANCOVA||||||-12.62|0.8039
73966889|NCT03743636|147470609|SUPERIORITY||Mean Difference (Final Values)|-842.0||||0.5352|ONE_SIDED|90.0|-13125.0||||ANCOVA||||||-13125|0.5352
73966890|NCT03743636|147470610|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.5777|ONE_SIDED|90.0|-2.46||||ANCOVA||||||-2.46|0.5777
73966891|NCT03743636|147470611|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.3662|ONE_SIDED|90.0|-5.69||||ANCOVA||||||-5.69|0.3662
74027856|NCT01462292|147609237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.946||||0.554|TWO_SIDED|95.0|-39.122|21.229||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilizing a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg||21.229|-39.122|0.554
74027857|NCT01462292|147609237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.099||||0.069|TWO_SIDED|95.0|-2.21|56.408||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilising a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg||56.408|-2.210|0.069
74027858|NCT01462292|147609238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.387||||0.699|TWO_SIDED|95.0|-1.618|2.392||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||2.392|-1.618|0.699
73919071|NCT02730455|147365963|SUPERIORITY||Odds Ratio (OR)|0.56||||0.085|TWO_SIDED|95.0|0.29|1.08|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.||1.08|0.29|0.085
73919072|NCT02730455|147365963|SUPERIORITY||Odds Ratio (OR)|0.54||||0.067|TWO_SIDED|95.0|0.28|1.04|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.||1.04|0.28|0.067
73861279|NCT00394901|147268635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.012||95.0|-3.56|-0.44|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.44|-3.56|0.012
73919073|NCT02730455|147365964|SUPERIORITY||Adjusted Mean Difference|-7.7||||0.106|TWO_SIDED|95.0|-16.97|1.64|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.64|-16.97|0.106
73919074|NCT02730455|147365964|SUPERIORITY||Adjusted Mean Difference|-6.1||||0.202|TWO_SIDED|95.0|-15.43|3.27|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||3.27|-15.43|0.202
73919075|NCT02730455|147365965|SUPERIORITY||Adjusted Mean Difference|-0.3||||0.78|TWO_SIDED|95.0|-2.64|1.99|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.99|-2.64|0.780
73919076|NCT02730455|147365965|SUPERIORITY||Adjusted Mean Difference|-0.6||||0.622|TWO_SIDED|95.0|-2.89|1.73|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.73|-2.89|0.622
73919077|NCT02730455|147365966|SUPERIORITY||Adjusted Mean Difference|1.2||||0.315|TWO_SIDED|95.0|-1.1|3.4|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||3.40|-1.10|0.315
73919078|NCT02730455|147365966|SUPERIORITY||Adjusted Mean Difference|-0.7||||0.542|TWO_SIDED|95.0|-2.96|1.56|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.56|-2.96|0.542
73919079|NCT02730455|147365969|SUPERIORITY|||||||0.028|||||||Cochran-Armitage trend test|||"mRS: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome.~Dose levels are log transformed."||||0.028
73919080|NCT02730455|147365969|SUPERIORITY|||||||0.049|||||||Cochran-Armitage trend test|||BI: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome. Dose levels are log transformed.||||0.049
73966892|NCT03743636|147470612|SUPERIORITY||Mean Difference (Final Values)|-11837.0||||0.8866|ONE_SIDED|90.0|-24396.0||||ANCOVA||||||-24396|0.8866
73966893|NCT03743636|147470613|SUPERIORITY|Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|Mean Difference (Final Values)|25.25||||0.0153|ONE_SIDED|90.0|10.43|||The a priori statistical analysis plan defined a one-sided P value of \< 0.10 to define statistical significance.|Mixed Models Analysis|||Mixed models for repeated measures were used to compare 3-month change in 6MW distance between the NR/resveratrol vs placebo groups and between the NR alone vs placebo groups using baseline, 3-month, and 6-month values, adjusted for age, sex, race, and baseline 6MW.|||10.43|0.0153
73861280|NCT00394901|147268636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.349||95.0|-0.91|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.32|-0.91|0.349
74027859|NCT01462292|147609238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.831||||0.384|TWO_SIDED|95.0|-1.072|2.735||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||2.735|-1.072|0.384
74027860|NCT01462292|147609239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.002||||0.997|TWO_SIDED|95.0|-0.883|0.886||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment,centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Ascent Week 24||0.886|-0.883|0.997
73919081|NCT02480439|147365977|SUPERIORITY_OR_OTHER||Point Estimate|0.966|||||TWO_SIDED|90.0|0.8747|1.0668|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0668|0.8747|
73919082|NCT02480439|147365977|SUPERIORITY_OR_OTHER||Point Estimate|0.9223|||||TWO_SIDED|90.0|0.8352|1.0185|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0185|0.8352|
73919083|NCT02480439|147365978|SUPERIORITY_OR_OTHER||Point Estimate|0.9998|||||TWO_SIDED|90.0|0.954|1.0477|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0477|0.9540|
73919084|NCT02480439|147365978|SUPERIORITY_OR_OTHER||Point Estimate|1.0149|||||TWO_SIDED|90.0|0.9685|1.0636|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0636|0.9685|
73919085|NCT02480439|147365979|SUPERIORITY_OR_OTHER||Point Estimate|0.9992|||||TWO_SIDED|90.0|0.9541|1.0464|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0464|0.9541|
73919086|NCT02480439|147365979|SUPERIORITY_OR_OTHER||Point Estimate|1.0134|||||TWO_SIDED|90.0|0.9676|1.0612|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0612|0.9676|
73919087|NCT01018186|147365993|SUPERIORITY_OR_OTHER||Ratio|1.67|||||TWO_SIDED|95.0|1.34|2.08|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12|||2.08|1.34|
73919088|NCT01018186|147365993|SUPERIORITY_OR_OTHER||Ratio|1.65|||||TWO_SIDED|95.0|1.29|2.13|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28|||2.13|1.29|
73919089|NCT01018186|147365993|SUPERIORITY_OR_OTHER||Ratio|1.05|||||TWO_SIDED|95.0|0.83|1.33|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52|||1.33|0.83|
73919090|NCT01018186|147365993|SUPERIORITY_OR_OTHER||Ratio|1.52|||||TWO_SIDED|95.0|1.22|1.89|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12|||1.89|1.22|
73919091|NCT01018186|147365993|SUPERIORITY_OR_OTHER||Ratio|1.43|||||TWO_SIDED|95.0|1.11|1.84|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28|||1.84|1.11|
74027861|NCT01462292|147609239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.803||||0.064|TWO_SIDED|95.0|-1.655|0.048||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Ascent, Week 24||0.048|-1.655|0.064
73919092|NCT01018186|147365993|SUPERIORITY_OR_OTHER||Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.38|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52|||1.38|0.87|
73919093|NCT01018186|147365994|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.67|||<|0.001|TWO_SIDED|95.0|1.34|2.08|||ANCOVA|||||2.08|1.34|<0.001
73919094|NCT01018186|147365994|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.52|||<|0.001|TWO_SIDED|95.0|1.22|1.89|||ANCOVA|||||1.89|1.22|<0.001
74027862|NCT01462292|147609239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.685||||0.311|TWO_SIDED|95.0|-2.033|0.662||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Descent Week 24||0.662|-2.033|0.311
74027863|NCT01462292|147609239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.412||||0.523|TWO_SIDED|95.0|-1.702|0.878||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Descent Week 24||0.878|-1.702|0.523
74027864|NCT01462292|147609240|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.564||||0.05|TWO_SIDED|95.0|0.0|1.127||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||1.127|0.000|0.050
74027865|NCT01462292|147609240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037||||0.89|TWO_SIDED|95.0|-0.498|0.571||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||0.571|-0.498|0.890
74027866|NCT01462292|147609241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.356||||0.723|TWO_SIDED|95.0|-10.936|15.648||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 3 mg||15.648|-10.936|0.723
73919095|NCT01018186|147365995|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.65|||<|0.001|TWO_SIDED|95.0|1.29|2.13|||ANCOVA|||||2.13|1.29|<0.001
73919096|NCT01018186|147365995|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.43||||0.006|TWO_SIDED|95.0|1.11|1.84|||ANCOVA|||||1.84|1.11|0.006
73919097|NCT01018186|147365996|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.05||||0.674|TWO_SIDED|95.0|0.83|1.33|||ANCOVA|||||1.33|0.83|0.674
73919098|NCT01018186|147365996|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.09||||0.444|TWO_SIDED|95.0|0.87|1.38|||ANCOVA|||||1.38|0.87|0.444
73919099|NCT03552198|147366013|OTHER|||||||0.964|||||||ANCOVA|ANCOVA, adjusted for baseline measures, tested for differences between intervention and control groups in preventative behaviours at 4 weeks||We predicted that the groups receiving the alternative format of air quality notifications would report greater frequency of behaviour change at 4 weeks compared to the groups receiving the usual format.||||.964
73919100|NCT03552198|147366014|OTHER|||||||0.043|||||||Chi-squared|χ2(1)=4.11, V=0.229||We predicted that more respondents in the intervention groups (i.e. receiving alternative health advice) would consider making permanent changes to their daily travel route, exercise location or exercise time compared to the control groups||||0.043
73919101|NCT03552198|147366015|OTHER||||||>|0.05|||||||Fisher Exact|||We predicted that the alternative health advice would lead to greater actual behaviour change compared to the usual format||||>0.05
73919102|NCT03552198|147366016|OTHER||||||>|0.05|||||||ANCOVA|ANCOVA, adjusted for baseline intentions, tested for differences between groups in intentions in relation to an high-air-pollution scenario at 4 weeks||We predicted that the alternative format would lead to stronger intentions to adhere to recommendations associated with an hypothetical high air pollution episode compared to the usual format.||||>0.05
73919103|NCT03235154|147366019|OTHER|There was no comparator arm in this small single arm study||||||||||||No confidence intervals around point estimates provided given very small number of participants||||This was a single arm intervention study with a very small number of participants. Therefore, only descriptive statistics are provided.|No confidence intervals around point estimates provided given very small number of participants|||
73919104|NCT03978520|147366053|SUPERIORITY||Response Rate Difference|12.8|||=|0.081|TWO_SIDED|95.0|-1.6|27.1|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||27.1|-1.6|=0.081
73919105|NCT03978520|147366053|SUPERIORITY||Response Rate Difference|16.9|||=|0.028|TWO_SIDED|95.0|1.8|31.9|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||31.9|1.8|=0.028
73919106|NCT03978520|147366053|SUPERIORITY||Response Rate Difference|-4.7|||=|0.566|TWO_SIDED|95.0|-20.8|11.4|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||11.4|-20.8|=0.566
73919107|NCT03978520|147366054|SUPERIORITY||Response Rate Difference|18.3|||=|0.013|TWO_SIDED|95.0|3.9|32.6|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||32.6|3.9|=0.013
73919108|NCT03978520|147366054|SUPERIORITY||Response Rate Difference|18.1|||=|0.018|TWO_SIDED|95.0|3.0|33.2|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||33.2|3.0|=0.018
73919109|NCT03978520|147366054|SUPERIORITY||Response Rate Difference|-1.2|||=|0.882|TWO_SIDED|95.0|-17.6|15.2|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||15.2|-17.6|=0.882
73919110|NCT03978520|147366055|SUPERIORITY||Response Rate Difference|14.7|||=|0.049|TWO_SIDED|95.0|0.0|29.4|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||29.4|0.0|=0.049
73919111|NCT03978520|147366055|SUPERIORITY||Response Rate Difference|13.9|||=|0.091|TWO_SIDED|95.0|-2.2|30.1|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||30.1|-2.2|=0.091
73919112|NCT03978520|147366055|SUPERIORITY||Response Rate Difference|-6.3|||=|0.447|TWO_SIDED|95.0|-22.5|9.9|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||9.9|-22.5|=0.447
73966894|NCT03743636|147470614|SUPERIORITY|Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|Mean Difference (Final Values)|14.05||||0.1195|ONE_SIDED|90.0|-1.25||||Mixed Models Analysis|||Mixed models for repeated measures were used to compare 6-month change in 6MW distance between the NR/resveratrol vs placebo groups and between the NR alone vs placebo groups using baseline, 3-month, and 6-month values, adjusted for age, sex, race, and baseline 6MW.|||-1.25|0.1195
73966895|NCT03743636|147470615|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0752|ONE_SIDED|90.0|0.24|||The a priori statistical analysis plan defined a one-sided P value of \< 0.10 to define statistical significance.|ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||0.24|0.0752
73919113|NCT03978520|147366056|SUPERIORITY||Response Rate Difference|16.7|||=|0.007|TWO_SIDED|95.0|4.5|28.9|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||28.9|4.5|=0.007
73919114|NCT03978520|147366056|SUPERIORITY||Response Rate Difference|31.0|||<|0.001|TWO_SIDED|95.0|18.1|44.0|||Cochran-Mantel-Haenszel|||Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo||44.0|18.1|<0.001
73919115|NCT03978520|147366056|SUPERIORITY||Response Rate Difference|-13.7|||=|0.068|TWO_SIDED|95.0|-28.4|1.0|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||1.0|-28.4|=0.068
73919116|NCT03978520|147366057|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.527|=|0.71|TWO_SIDED|95.0|-0.84|1.23|||Mixed-effect model repeat measurement|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.23|-0.84|=0.710
73919117|NCT03978520|147366057|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.545|=|0.963|TWO_SIDED|95.0|-1.05|1.1|||Mixed-effect model repeat measurement|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.10|-1.05|=0.963
73919118|NCT03978520|147366057|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.547|=|0.754|TWO_SIDED|95.0|-0.9|1.25|||Mixed-effect model repeat measurement|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.25|-0.90|=0.754
73919119|NCT03978520|147366058|SUPERIORITY||Rate difference|-1.06|||=|0.002|TWO_SIDED|95.0|-1.74|-0.39|||Binomial regression|||"Mild/Moderate~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.39|-1.74|=0.002
73919120|NCT03978520|147366058|SUPERIORITY||Rate Difference|-0.69|||=|0.059|TWO_SIDED|95.0|-1.41|0.03|||Binomial regression|||"Mild/Moderate~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.03|-1.41|=0.059
73919121|NCT03978520|147366058|SUPERIORITY||Rate Difference|-0.37|||=|0.252|TWO_SIDED|95.0|-1.01|0.27|||Binomial regression|||"Mild/Moderate~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.27|-1.01|=0.252
73919122|NCT03978520|147366058|SUPERIORITY||Rate Difference|-0.1|||=|0.467|TWO_SIDED|95.0|-0.37|0.17|||Binomial regression|||"Severe~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.17|-0.37|=0.467
73919123|NCT03978520|147366058|SUPERIORITY||Rate Difference|-0.26|||=|0.033|TWO_SIDED|95.0|-0.49|-0.02|||Binomial regression|||"Severe~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.02|-0.49|=0.033
74027867|NCT01462292|147609241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.821||||0.898|TWO_SIDED|95.0|-12.034|13.676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 6mg||13.676|-12.034|0.898
73966896|NCT03743636|147470616|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.8703|ONE_SIDED|90.0|-15.19||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-15.19|0.8703
74027868|NCT01462292|147609243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.684|TWO_SIDED|95.0|-2.9|1.92||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||1.92|-2.90|0.684
73861281|NCT00394901|147268636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.024||95.0|-1.32|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.32|0.024
73919124|NCT03978520|147366058|SUPERIORITY||Rate Difference|0.15|||=|0.156|TWO_SIDED|95.0|-0.06|0.37|||Binomial regression|||"Severe~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.37|-0.06|=0.156
73919125|NCT03978520|147366058|SUPERIORITY||Rate Difference|-1.16|||=|0.002|TWO_SIDED|95.0|-1.89|-0.44|||Binomial regression|||"Overall~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.44|-1.89|=0.002
73919126|NCT03978520|147366058|SUPERIORITY||Rate Difference|-0.95|||=|0.014|TWO_SIDED|95.0|-1.7|-0.19|||Binomial regression|||"Overall~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.19|-1.70|=0.014
73919127|NCT03978520|147366058|SUPERIORITY||Rate Difference|-0.22|||=|0.526|TWO_SIDED|95.0|-0.89|0.46|||Binomial regression|||"Overall~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.46|-0.89|=0.526
73919128|NCT01648205|147366069|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_DEVIATION|26.8||0.7958|TWO_SIDED|95.0|-14.1|11.0|||t-test, 2 sided|Paired t-test was used||||11.0|-14.1|0.7958
73919129|NCT01648205|147366070|SUPERIORITY||Median Difference (Final Values)|8.4|STANDARD_DEVIATION|35.9||0.3369|TWO_SIDED|95.0|-9.5|26.2|||t-test, 2 sided|Paired t-test was used||||26.2|-9.5|0.3369
73919130|NCT02345850|147366140|SUPERIORITY||Hazard Ratio (HR)|0.805||||0.2368|TWO_SIDED|95.0|0.562|1.154||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between CD34 select graft vs. Tac/MTX Control. The data in primary outcome table provides point estimates at specific time points (1 year and 2 years post randomization). The statistics in this session provides comparisons between different arms for the entire period of the study.||1.154|0.562|0.2368
73966897|NCT03743636|147470617|SUPERIORITY||Mean Difference (Final Values)|10995.0||||0.1402|ONE_SIDED|90.0|-2078.0||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-2078|0.1402
73919131|NCT02345850|147366140|SUPERIORITY||Hazard Ratio (HR)|0.864||||0.4134|TWO_SIDED|95.0|0.609|1.228||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between Post-Transplant Cyclophosphamide vs. Tac/MTX Control. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||1.228|0.609|0.4134
73919132|NCT02345850|147366140|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.7166|TWO_SIDED|95.0|0.643|1.355||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between CD34 select graft vs. Post-Transplant Cyclophosphamide. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||1.355|0.643|0.7166
73919133|NCT02345850|147366140|SUPERIORITY|||||||0.386||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the CRFS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||||0.386
73919134|NCT02345850|147366140|SUPERIORITY|||||||0.461||||||A Bonferroni adjusted significance level of 0.05/3=0.0167 is used for each of three interaction tests to account for multiple testing.|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and disease risk (Low/Intermediate vs. High) for CRFS.||||0.461
73919135|NCT02345850|147366140|SUPERIORITY|||||||0.115||||||Cox proportional hazards regression|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and Age (\<=50 vs. \>50) for CRFS.||||0.115
73861282|NCT00394901|147268636|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.045||95.0|-1.21|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.01|-1.21|0.045
73966898|NCT03743636|147470618|SUPERIORITY||Mean Difference (Final Values)|-35.13||||0.8401|ONE_SIDED|90.0|-81.2||||ANCOVA||||||-81.20|0.8401
73966899|NCT03743636|147470619|SUPERIORITY||Mean Difference (Final Values)|11.14||||0.0602|ONE_SIDED|90.0|2.16||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||2.16|0.0602
74088427|NCT00107042|147730241|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3474|STANDARD_ERROR_OF_MEAN|0.3924||0.3788||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever used drugs not prescribed(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.3788
73966900|NCT03743636|147470620|SUPERIORITY||Mean Difference (Final Values)|5.21||||0.2378|ONE_SIDED|90.0|-4.47||||ANCOVA||||||-4.47|0.2378
73919136|NCT02345850|147366140|SUPERIORITY|||||||0.227||||||A Bonferroni adjusted significance level of 0.05/3=0.0167 is used for each of three interaction tests to account for multiple testing.|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and Disease (AML vs. ALL vs. MDS) for CRFS.||||0.227
73919137|NCT02345850|147366141|SUPERIORITY||Hazard Ratio (HR)|1.744||||0.0197|TWO_SIDED|95.0|1.086|2.8||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between CD34 select graft vs. Tac/MTX Control.||2.800|1.086|0.0197
73919138|NCT02345850|147366141|SUPERIORITY||Hazard Ratio (HR)|1.016||||0.9525|TWO_SIDED|95.0|0.599|1.724||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between Post-Transplant Cyclophosphamide vs. Tac/MTX Control.||1.724|0.599|0.9525
73919139|NCT02345850|147366141|SUPERIORITY||Hazard Ratio (HR)|1.774||||0.0185|TWO_SIDED|95.0|1.093|2.877||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between CD34 select graft vs. Post-Transplant Cyclophosphamide.||2.877|1.093|0.0185
73919140|NCT02345850|147366141|SUPERIORITY|||||||0.026||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the OS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.026
73919141|NCT02345850|147366142|SUPERIORITY|||||||0.029||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference of Relapse-Free Survival between the treatment groups.||||0.029
73919142|NCT02345850|147366142|SUPERIORITY|||||||0.145||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the RFS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.145
73919143|NCT02345850|147366143|SUPERIORITY|||||||0.02||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Transplant-Related Mortality between the treatment groups.||||0.020
74027869|NCT01462292|147609243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.873|TWO_SIDED|95.0|-2.49|2.12||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||2.12|-2.49|0.873
74088428|NCT00107042|147730242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54||||0.2068|TWO_SIDED|95.0|0.6|10.76|||Univariate regression, logistic||The reference group is the 'Recombivax' group.|||10.76|0.60|0.2068
74088429|NCT00107042|147730243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.5524|TWO_SIDED|95.0|0.38|6.01|||Univariate regression, logistic||The reference group is the 'Other Sites' group.|||6.01|0.38|0.5524
74088430|NCT00107042|147730244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.4646|TWO_SIDED|95.0|0.36|9.36|||Univariate regression, logistic||The reference group is the '15-17 year' age group|||9.36|0.36|0.4646
74088431|NCT00107042|147730245|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.339|TWO_SIDED|95.0|0.09|2.3|||Univariate regression, logistic||The reference group is the 'Female' group.|||2.30|0.09|0.3390
74088432|NCT00107042|147730246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.86||||0.0102|TWO_SIDED|95.0|1.58|29.78|||Univariate regression, logistic||The reference group is the 'Hispanic: NO' group.|||29.78|1.58|0.0102
74088433|NCT00107042|147730246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.38||||0.0118|TWO_SIDED|95.0|1.56|34.95||Since Hispanic (no, yes) was a factor with a p-value of \< 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Hispanic: NO group."|||34.95|1.56|0.0118
74088434|NCT00107042|147730247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.4241|TWO_SIDED|95.0|0.04|3.84|||Univariate regression, logistic||The reference group is the 'White' group.|||3.84|0.04|0.4241
74088435|NCT00107042|147730247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12||||0.2685|TWO_SIDED|95.0|0.34|50.76|||Univariate regression, logistic||The reference group is the 'White' group.|||50.76|0.34|0.2685
74088436|NCT00107042|147730248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.939|TWO_SIDED|95.0|0.05|15.44|||Univariate regression, logistic||The reference group is the 'Stage 5' group.|||15.44|0.05|0.9390
74088437|NCT00107042|147730249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.6181|TWO_SIDED|95.0|0.3|7.39|||Univariate regression, logistic||"The reference group is the Stage 5 group."|||7.39|0.30|0.6181
74088438|NCT00107042|147730250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.1943|TWO_SIDED|95.0|0.1|1.6|||Univariate regression, logistic||"The reference group is the Normal and Underweight (\<25.0) group."|||1.60|0.10|0.1943
74088439|NCT00107042|147730251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.2542|TWO_SIDED|95.0|0.1|1.86|||Univariate regression, logistic||"The reference group is the Ever smoked cigarettes: NO group."|||1.86|0.10|0.2542
74088440|NCT00107042|147730252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.14||||0.0161|TWO_SIDED|95.0|0.03|0.69|||Univariate regression, logistic||"The reference group is the Straight (heterosexual) group."|||0.69|0.03|0.0161
74088441|NCT00107042|147730252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12||||0.0222|TWO_SIDED|95.0|0.02|0.74||Since sexual identity was a factor with a p-value of \< 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Straight (heterosexual) group."|||0.74|0.02|0.0222
74088442|NCT00107042|147730253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8945|TWO_SIDED|95.0|0.12|11.83|||Univariate regression, logistic||"The reference group is the Never (had sex)group."|||11.83|0.12|0.8945
74088443|NCT00107042|147730253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12||||0.019|TWO_SIDED|95.0|0.02|0.7|||Univariate regression, logistic||"The reference group is the Never (had sex) group."|||0.70|0.02|0.0190
74088444|NCT00107042|147730254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||0.0042|TWO_SIDED|95.0|0.01|0.48|||Univariate regression, logistic||"The reference group is the 0 partners group"|||0.48|0.01|0.0042
74027870|NCT01462292|147609245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-892.88||||0.61|TWO_SIDED|95.0|-4391.1|2605.35||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 24||2605.35|-4391.10|0.610
74027871|NCT01462292|147609245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2054.86||||0.248|TWO_SIDED|95.0|-5587.33|1477.6||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 48||1477.60|-5587.33|0.248
74027872|NCT01462292|147609245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1305.46||||0.439|TWO_SIDED|95.0|-4668.41|2057.48||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 24||2057.48|-4668.41|0.439
73919144|NCT02345850|147366143|SUPERIORITY|||||||0.04||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the TRM hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.040
73861283|NCT00394901|147268637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83||||0.441||95.0|-2.93|1.28|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.28|-2.93|0.441
73861284|NCT00394901|147268637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.55||||0.017||95.0|-4.64|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-4.64|0.017
73861285|NCT00394901|147268637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.61||||0.012||95.0|-4.65|-0.56|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-4.65|0.012
73861286|NCT00394901|147268638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.23||||0.47||95.0|-8.28|3.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.83|-8.28|0.470
73861287|NCT00394901|147268638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.04||||0.008||95.0|-14.0|-2.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.06|-14.0|0.008
73861288|NCT00394901|147268638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.43||||0.013||95.0|-13.3|-1.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-1.59|-13.3|0.013
73861289|NCT00394901|147268639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.178||95.0|-0.48|0.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.09|-0.48|0.178
73861290|NCT00394901|147268639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.003||95.0|-0.72|-0.15|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.15|-0.72|0.003
73861291|NCT00394901|147268639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.03||95.0|-0.59|-0.03|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.03|-0.59|0.030
73861292|NCT00394901|147268640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76||||0.001||95.0|-1.23|-0.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.30|-1.23|0.001
73861293|NCT00394901|147268640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81||||0.001||95.0|-1.27|-0.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.34|-1.27|0.001
73861294|NCT00394901|147268640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.4|-0.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.49|-1.40|<0.001
73861295|NCT00394901|147268641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9||||0.001||95.0|-14.2|-3.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-3.61|-14.2|0.001
73861296|NCT00394901|147268641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.24||||0.002||95.0|-13.5|-2.99|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.99|-13.5|0.002
73861297|NCT00394901|147268641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.3|||<|0.001||95.0|-16.5|-6.22|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-6.22|-16.5|<0.001
73861298|NCT00394901|147268642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.29||||0.245||95.0|-2.95|11.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.54|-2.95|0.245
73861299|NCT00394901|147268642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.95||||0.417||95.0|-4.2|10.11|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.11|-4.20|0.417
73919145|NCT02345850|147366144|SUPERIORITY|||||||0.2389||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||The null hypothesis is that there is no difference of immunosuppression-free survival at 1-year post-transplant between the treatment groups.||||0.2389
74027873|NCT01462292|147609245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|167.39||||0.921|TWO_SIDED|95.0|-3208.98|3543.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 48||3543.77|-3208.98|0.921
74027874|NCT01462292|147609252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.541|TWO_SIDED|95.0|0.02|7.01||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 3 mg/kg/week||7.01|0.02|0.541
74027875|NCT01462292|147609252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.417|TWO_SIDED|95.0|0.03|4.27||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 6 mg/kg/week||4.27|0.03|0.417
73919146|NCT02345850|147366144|SUPERIORITY||||||<|0.0001|||||||Cohen's Kappa|||The null hypothesis is that there is no agreement between CRFS and immunosuppression-free survival at 1-year post-transplant.||||<0.0001
73919147|NCT02345850|147366145|SUPERIORITY|||||||0.076||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Disease Relapse between the treatment groups.||||0.076
73919148|NCT02345850|147366145|SUPERIORITY|||||||0.106||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the Disease Relapse hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.106
73919149|NCT02345850|147366146|SUPERIORITY|||||||0.0764||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Neutrophil Engraftment post-transplantation between the treatment groups.||||0.0764
73919150|NCT02345850|147366147|SUPERIORITY|||||||0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet recovery post-transplantation between the treatment groups.||||0.0001
73919151|NCT02345850|147366149|SUPERIORITY|||||||0.1478|||||||Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Secondary graft failure post-transplantation between the treatment groups.||||0.1478
73919152|NCT02345850|147366150|SUPERIORITY|||||||0.0026||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups.||||0.0026
73919153|NCT02345850|147366150|SUPERIORITY|||||||0.0369||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade III-IV acute GVHD post-transplantation between the treatment groups.||||0.0369
73919154|NCT02345850|147366150|SUPERIORITY|||||||0.002||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the grade II-IV acute GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.002
73919155|NCT02345850|147366150|SUPERIORITY|||||||0.046||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the grade III-IV acute GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.046
73919156|NCT02345850|147366152|SUPERIORITY|||||||0.0024||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of chronic GVHD post-transplantation between the treatment groups.||||0.0024
73966901|NCT03743636|147470621|SUPERIORITY||Mean Difference (Final Values)|6.05||||0.1589|ONE_SIDED|90.0|-1.86||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-1.86|0.1589
73966902|NCT03743636|147470621|SUPERIORITY||Mean Difference (Final Values)|11.14||||0.0602|ONE_SIDED|90.0|2.16||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||2.16|0.0602
73919157|NCT02345850|147366152|SUPERIORITY|||||||0.005||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the chronic GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.005
73919158|NCT02345850|147366153|SUPERIORITY|||||||0.229||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference of Chronic GVHD-free Survival post-transplantation between the treatment groups.||||0.229
73919159|NCT02345850|147366155|SUPERIORITY|||||||0.0006||||||Superiority - Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grades II-III infection post-transplantation between the treatment groups.||||0.0006
73966903|NCT03743636|147470622|SUPERIORITY||Mean Difference (Final Values)|10.25||||0.3724|ONE_SIDED|90.0|-31.79||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-31.79|0.3724
73966904|NCT03743636|147470622|SUPERIORITY||Mean Difference (Final Values)|-35.13||||0.8401|ONE_SIDED|90.0|-81.2||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-81.20|0.8401
74027876|NCT01145391|147609255|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence||||||0.5||95.0||||For systolic blood pressure|Mixed Models Analysis|||||||0.50
74027877|NCT01274897|147609296|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|71.0|||||TWO_SIDED|95.0|71.0|81.0||The immune response considered sufficient if for serogroup A the lower limit of the two-sided 95% Clopper-Pearson confidence interval (CI) of the percentage of subjects with hSBA seroresponse is ≥50%.|Clopper and Pearson||For serogroup A.|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||81|71|
74027878|NCT01274897|147609296|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|82.0|||||TWO_SIDED|95.0|82.0|90.0||The immune response was considered sufficient if for serogroup C, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For the serogroup C|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||90|82|
73919160|NCT02345850|147366155|SUPERIORITY|||||||0.0145||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grades III infection post-transplantation between the treatment groups.||||0.0145
74086583|NCT04100096|147726638|SUPERIORITY||LS Mean Difference|-0.14||||0.4277|TWO_SIDED|95.0|-0.48|0.21||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 12||0.21|-0.48|0.4277
73861300|NCT00394901|147268642|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7||||0.007||95.0|2.67|16.74|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||16.74|2.67|0.007
73861301|NCT00394901|147268643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.76||95.0|-3.83|5.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.24|-3.83|0.760
73861302|NCT00394901|147268643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.754||95.0|-3.75|5.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.18|-3.75|0.754
73861303|NCT00394901|147268643|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04||||0.641||95.0|-5.43|3.35|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.35|-5.43|0.641
73861304|NCT00394901|147268644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.955||95.0|-0.3|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.32|-0.30|0.955
73861305|NCT00394901|147268644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27||||0.084||95.0|-0.04|0.58|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.58|-0.04|0.084
73861306|NCT00394901|147268644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.17||95.0|-0.09|0.52|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.52|-0.09|0.170
73861307|NCT00394901|147268645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.01||||0.296||95.0|-3.52|11.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.55|-3.52|0.296
73861308|NCT00394901|147268645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3||||0.007||95.0|2.87|17.73|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.73|2.87|0.007
73861309|NCT00394901|147268645|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0||||0.106||95.0|-1.29|13.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.30|-1.29|0.106
73861310|NCT00394901|147268646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.93||||0.191||95.0|-1.97|9.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.83|-1.97|0.191
73861311|NCT00394901|147268646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.21|||<|0.001||95.0|5.41|17.02|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.02|5.41|<0.001
73861312|NCT00394901|147268646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.23|||<|0.001||95.0|8.5|19.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||19.95|8.50|<0.001
73919161|NCT02715076|147366161|OTHER||||||<|0.05|||||||mixed-effects model|||||||<0.05
73861313|NCT00394901|147268647|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.03||||0.061||95.0|-8.25|0.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.18|-8.25|0.061
73919162|NCT01991067|147366162|OTHER|Furthermore, a multivariable logistic regression model was applied accounting for group as well as age, body mass index, and gender as possible influence factors.|||||<|0.001||||||The threshold for statistical significance was a p-value of \<0.05.|Fisher Exact|||The calculation of the sample size was performed using nQuery 6.1. The primary endpoint was the outcome of the NT 4 weeks after the second vaccination. A Fisher exact tes was calculated to analyze the primary hypothesis on the difference in NT-titer response between patients and controls||||<0.001
74086584|NCT04100096|147726639|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6225|TWO_SIDED|95.0|-0.18|0.3||Comparison between TGs was carried out using the Cochran-Mantel-Haenszel (CMH) Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 2||0.30|-0.18|0.6225
73861314|NCT00394901|147268647|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.133||95.0|-7.37|0.98|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.98|-7.37|0.133
73861315|NCT00394901|147268647|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.44||||0.24||95.0|-6.52|1.64|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.64|-6.52|0.240
73861316|NCT00394901|147268648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.68||||0.2842||95.0|0.34|1.37|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.37|0.34|0.2842
73919163|NCT01991067|147366163|OTHER|||||||0.02|||||||Fisher Exact|||A Fisher exact test was calculated to analyze antibody response by ELISA between patients and controls. To measure the Agreement between the NT and ELISA response, Cohens Kappa and the corresponding 95% confidence interval were calculated||||0.02
73919164|NCT01991067|147366164|OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"For titer values the geometric mean was calculated and the corresponding two-sided 95% confidence intervals were constructed by back-transfomration of the CI for the mean of the logarithmically transformed results.~To investigate the difference in absolute titer values and geometric mean fold changes between time point and Groups, Wilcoxon tests were performed."||||<0.01
73919165|NCT02692716|147366214|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Non-inferiority of oral semaglutide versus placebo was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was strictly below 1.8.|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|95.0|0.57|1.11||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first event adjudication committee (EAC) confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.11|0.57|< 0.0001
73919166|NCT02692716|147366214|SUPERIORITY|This hypothesis was controlled for multiplicity.|Hazard Ratio (HR)|0.79|||=|0.1749|TWO_SIDED|95.0|0.57|1.11||Unadjusted two-sided p-value from test of no difference from 1 (superiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.11|0.57|= 0.1749
73919167|NCT02692716|147366215|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.82|||=|0.1827|TWO_SIDED|95.0|0.61|1.1||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed expanded cardiovascular outcome was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.10|0.61|= 0.1827
73919168|NCT02692716|147366216|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.49|||=|0.0261|TWO_SIDED|95.0|0.27|0.92||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed cardiovascular death (including undetermined cause of death) was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||0.92|0.27|= 0.0261
73919169|NCT02692716|147366216|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.18|||=|0.5044|TWO_SIDED|95.0|0.73|1.9||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.90|0.73|= 0.5044
73919170|NCT02692716|147366216|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.74|||=|0.435|TWO_SIDED|95.0|0.35|1.57||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.57|0.35|= 0.4350
73966905|NCT03743636|147470623|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.5558|ONE_SIDED|90.0|-9.52||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-9.52|0.5558
73966906|NCT03743636|147470623|SUPERIORITY||Mean Difference (Final Values)|5.21||||0.2378|ONE_SIDED|90.0|-4.47||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-4.47|0.2378
73966907|NCT03743636|147470624|SUPERIORITY||Mean Difference (Final Values)|-2.71||||0.7112|ONE_SIDED|90.0|-8.97||||ANCOVA||||||-8.97|0.7112
73966908|NCT03743636|147470625|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.9449|ONE_SIDED|90.0|-13.31||||ANCOVA||||||-13.31|0.9449
73966909|NCT03743636|147470626|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.5409|ONE_SIDED|90.0|-6.57||||ANCOVA||||||-6.57|0.5409
74086585|NCT04100096|147726639|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9145|TWO_SIDED|95.0|-0.35|0.31||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 4||0.31|-0.35|0.9145
73966910|NCT03743636|147470627|SUPERIORITY||Mean Difference (Final Values)|-3.35||||0.7814|ONE_SIDED|90.0|-8.89||||ANCOVA||||||-8.89|0.7814
73966911|NCT03743636|147470628|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.5884|ONE_SIDED|90.0|-7.07||||ANCOVA||||||-7.07|0.5884
73966912|NCT03743636|147470629|SUPERIORITY||Mean Difference (Final Values)|4.05||||0.1787|ONE_SIDED|90.0|-1.6||||ANCOVA||||||-1.60|0.1787
73966913|NCT03743636|147470630|SUPERIORITY||Mean Difference (Final Values)|-2.71||||0.7112|ONE_SIDED|90.0|-8.97||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-8.97|0.7112
74088445|NCT00107042|147730254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.6893||95.0|||||Univariate regression, Logistic||"The reference group is the 0 partners group.~Two sided 95% confidence interval: Lower Limit = 0.17; upper limit = infinity"|||||0.6893
73919171|NCT02692716|147366216|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.56|||=|0.3605|TWO_SIDED|95.0|0.6|4.01||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed unstable angina pectoris requiring hospitalisation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||4.01|0.60|= 0.3605
73919172|NCT02692716|147366216|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.86|||=|0.6227|TWO_SIDED|95.0|0.48|1.55||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed hospitalisation for heart failure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.55|0.48|= 0.6227
74088446|NCT00107042|147730255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.015||||0.0003|TWO_SIDED|95.0|0.0|0.19|||Univariate regression, logistic||"The reference group is hte 0 Partners group."|||0.19|0.00|0.0003
73861317|NCT00394901|147268648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.89||||0.0577||95.0|0.98|3.66|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.66|0.98|0.0577
73861318|NCT00394901|147268648|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||0.1893||95.0|0.81|2.95|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.95|0.81|0.1893
73861319|NCT00394901|147268649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0466
73861320|NCT00394901|147268649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
73861321|NCT00394901|147268649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
73861322|NCT00394901|147268650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.3440
73861323|NCT00394901|147268650|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
73861324|NCT00394901|147268650|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
73861325|NCT00394901|147268651|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.51||||0.057||95.0|-0.1|7.13|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.13|-0.10|0.057
73861326|NCT00394901|147268651|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.67||95.0|-2.78|4.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.32|-2.78|0.670
73861327|NCT00394901|147268651|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.04||||0.559||95.0|-2.45|4.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.53|-2.45|0.559
73861328|NCT00394901|147268652|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.4||||0.004||95.0|3.01|15.78|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||15.78|3.01|0.004
73861329|NCT00394901|147268652|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.67||||0.037||95.0|0.39|12.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.95|0.39|0.037
73861330|NCT00394901|147268652|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.46||||0.643||95.0|-4.74|7.66|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.66|-4.74|0.643
73861331|NCT00394901|147268653|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62||||0.811||95.0|-4.5|5.75|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.75|-4.50|0.811
73861332|NCT00394901|147268653|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.07||||0.006||95.0|2.03|12.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.12|2.03|0.006
73861333|NCT00394901|147268653|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.03||||0.047||95.0|0.06|10.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.00|0.06|0.047
73861334|NCT00394901|147268654|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3||||0.013||95.0|1.1|9.5|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.50|1.10|0.013
73861335|NCT00394901|147268654|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.82||||0.07||95.0|-0.31|7.96|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.96|-0.31|0.070
73861336|NCT00394901|147268654|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.93||||0.058||95.0|-0.13|8.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.00|-0.13|0.058
73966914|NCT03743636|147470631|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.9449|ONE_SIDED|90.0|-13.31||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-13.31|0.9449
73966915|NCT05691452|147470634|SUPERIORITY||Mean Difference (Net)|20.05||||0.578|TWO_SIDED|95.0|-50.68|90.78||Generalized linear models generated estimated mean differences in the post-intervention values controlling for the baseline assessments.|Regression, Linear|||||90.78|-50.68|0.578
73966916|NCT05691452|147470635|SUPERIORITY||Mean Difference (Net)|-21.2||||0.61|TWO_SIDED|95.0|-101.9|59.5|||Regression, Linear|||||59.5|-101.9|0.61
73966917|NCT05691452|147470636|SUPERIORITY||Mean Difference (Net)|1.55||||0.674|TWO_SIDED|95.0|-5.68|8.78|||Regression, Linear|||||8.78|-5.68|0.674
73966918|NCT05691452|147470637|SUPERIORITY||Mean Difference (Net)|-21.6||||0.013|TWO_SIDED|95.0|-38.5|-4.59|||Regression, Linear|||||-4.59|-38.5|.013
73966919|NCT05691452|147470638|SUPERIORITY||Mean Difference (Net)|0.387||||0.29|TWO_SIDED|95.0|-0.335|1.109|||Regression, Linear|||||1.109|-0.335|0.29
73966920|NCT05691452|147470639|SUPERIORITY||Mean Difference (Net)|-0.203||||0.701|TWO_SIDED|95.0|-1.24|0.833|||Regression, Linear|||||0.833|-1.24|0.701
73966921|NCT05691452|147470640|SUPERIORITY||Mean Difference (Net)|-21.45||||0.376|TWO_SIDED|95.0|-68.99|26.08|||Regression, Linear|||||26.08|-68.99|0.376
73966922|NCT02379156|147470769|SUPERIORITY||||||<|0.001|||||||ANOVA|||Between-group differences in the change in core body temperature (Tcore) from baseline (BL) values to after cold exposure (Cold) were analyzed using a Mixed Model ANOVA. We hypothesized that participants with tetraplegia would have a greater decrease in Tcore when exposed to cool ambient temperature than control participants exposed to the same cool ambient temperature.||||<0.001
74027879|NCT01274897|147609296|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|23.0|||||TWO_SIDED|95.0|23.0|33.0||The immune response was considered sufficient if for serogroup W, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For the serogroup W|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||33|23|
73861337|NCT00394901|147268655|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.43||||0.443||95.0|-3.79|8.65|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.65|-3.79|0.443
74086586|NCT04100096|147726639|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.1535|TWO_SIDED|95.0|-0.52|0.08||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 6||0.08|-0.52|0.1535
73861338|NCT00394901|147268655|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.41||||0.018||95.0|1.28|13.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.54|1.28|0.018
73861339|NCT00394901|147268655|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83||||0.549||95.0|-4.18|7.85|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.85|-4.18|0.549
73861340|NCT00394901|147268656|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.15||||0.075||95.0|-0.63|12.92|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.92|-0.63|0.075
73861341|NCT00394901|147268656|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.41||||0.111||95.0|-1.25|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.08|-1.25|0.111
73861342|NCT00394901|147268656|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.02||||0.366||95.0|-3.55|9.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.60|-3.55|0.366
73861343|NCT00394901|147268657|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.64||||0.039||95.0|0.29|11.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.00|0.29|0.039
73966923|NCT02379156|147470769|SUPERIORITY|||||||0.006|||||||ANOVA|||Within-group differences in the change in (Tcore) in the participants with tetraplegia from BL values to Cold, with and without a dose of 10 mg of midodrine (two separate visits), were analyzed using a Repeated Measures ANOVA .||||0.006
73966924|NCT02379156|147470770|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||Between-group differences in the percent change in total WAIS IV scores from BL to after cold ambient exposure were analyzed using an independent samples T-test. We hypothesized that participants with tetraplegia would have a greater percent change in total WAIS IV scores due to impaired cognitive function post cool ambient exposure.||||.042
73966925|NCT02379156|147470770|SUPERIORITY|||||||0.149|||||||t-test, 2 sided|||"Within-group differences in the percent change in total WAIS IV scores from BL to after cold ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a greater percent change in total WAIS IV scores than the same participants in the With drug condition."||||0.149
73966926|NCT02379156|147470771|SUPERIORITY||||||<|0.001|||||||ANOVA|||Between-group differences in the change in distal skin temperature temperature (Tsk) from baseline (BL) values to after ambient cold exposure (Cold) were analyzed using a mixed-model ANOVA for the AB vs Tetra comparison. We hypothesized that participants with tetraplegia would have a smaller change in Tsk due to being in a constant state of vasodilation.||||<0.001
73966927|NCT02379156|147470771|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within-group differences in the change in distal skin temperature temperature (Tsk) from baseline (BL) values to after ambient cold exposure (Cold) were analyzed using a repeated measures ANOVA for the within-group comparison of drug vs no drug in the tetraplegia group. We hypothesized that participants with tetraplegia with drug would have a larger decrease in Tsk due to enhanced peripheral vasoconstriction due to the drug's effects.||||<.001
73919173|NCT02692716|147366217|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0.0952|TWO_SIDED|95.0|0.56|1.05||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death, non-fatal myocardial infarction or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.05|0.56|= 0.0952
73919174|NCT02692716|147366218|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.04||||0.8583|TWO_SIDED|95.0|0.66|1.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the on-treatment observation period. Time from first dose of trial product to first EAC-confirmed fatal or non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their on-treatment observation period.||1.66|0.66|0.8583
73919175|NCT02692716|147366219|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.76||||0.4485|TWO_SIDED|95.0|0.37|1.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed fatal or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.56|0.37|0.4485
73919176|NCT02692716|147366220|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.51||||0.0078|TWO_SIDED|95.0|0.31|0.84||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||0.84|0.31|0.0078
73919177|NCT02692716|147366221|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.42|2.3||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from date of first dose of trial product to date of end of treatment visit. Time from first dose to first AE leading to permanent trial product discontinuation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the date of their end of treatment visit or at their end of study date, whichever came first.||2.30|1.42|<0.0001
73919178|NCT02782780|147366234|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.01||||||Test of treatment effect: t(91.6)=3.21|Mixed Models Analysis|||||||<0.01
73919179|NCT02782780|147366234|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTI group: t(92.3)=4.10|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTI group.||||||<0.001
73919180|NCT02782780|147366235|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.001||||||test of treatment effect: t(94.7)=6.10|Mixed Models Analysis|||||||<0.001
73919181|NCT02782780|147366235|SUPERIORITY||||||<|0.001||||||baseline vs. 6-month follow-up in CBTI group: t(94)=6.67|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTI group.||To compare baseline data to 6-month follow-up data in the CBT-I group, planned contrasts following the mixed models were used.||||<0.001
73966928|NCT02379156|147470772|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Between-group differences in the percent change in microvascular perfusion from baseline to after cool ambient exposure were analyzed using independent samples T-test. We hypothesized that participants with tetraplegia would have a smaller percent change in microvascular perfusion due impaired vasomotor control which causes a constant state of vasodilation.||||<0.001
73966929|NCT02379156|147470772|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||"Within-group differences in the percent change in microvascular perfusion from baseline to after cool ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a smaller percent change in microvascular perfusion due impaired vasomotor control which causes a constant state of vasodilation."||||0.066
73919182|NCT02782780|147366236|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.001|||||||Mixed Models Analysis|test of treatment effect: t(104)=3.40||||||<0.001
73919183|NCT02782780|147366236|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(91.6)=4.37|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
73919184|NCT02782780|147366237|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.05|||||||Mixed Models Analysis|test of treatment effect: t(99.9)=2.09||||||<0.05
73966930|NCT02379156|147470773|SUPERIORITY|||||||0.127|||||||t-test, 2 sided|||Between-group differences in the percent change in VO2 from baseline to after cool ambient exposure were analyzed using independent samples t-test. We hypothesized that participants with tetraplegia would have a smaller percent change in VO2 consumption.||||0.127
73966931|NCT02379156|147470773|SUPERIORITY|||||||0.964|||||||t-test, 2 sided|||"Within-group differences in the percent change in VO2 consumption from baseline to after cool ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a greater percent change in VO2 consumption due to impaired vasoconstriction and greater heat loss compared to the With Drug condition, in response to cool ambient exposure."||||0.964
73966932|NCT04549168|147470786|SUPERIORITY||LS geometric mean ratio|0.795||||0.0585|TWO_SIDED|95.0|0.627|1.008||Data was analyzed using mixed effect model repeated measurement analysis (MMRM), and the missing values were imputed using multiple imputation and assumed to be missing not at random (MNAR).|MMRM|||||1.008|0.627|0.0585
73966933|NCT04549168|147470787|SUPERIORITY||LSM difference|7.1|||<|0.0001|TWO_SIDED|95.0|4.39|9.81||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||9.81|4.39|<0.0001
74027880|NCT01274897|147609296|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|63.0|||||TWO_SIDED|95.0|63.0|74.0||The immune response was considered sufficient if for serogroup Y, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For serogroup Y|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||74|63|
74027881|NCT02042131|147609300|SUPERIORITY|||||||0.082|||||||Log Rank|||Omnibus test of all three groups||||.082
74027882|NCT02042131|147609300|SUPERIORITY|||||||0.028|||||||Log Rank|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||.028
73861344|NCT00394901|147268657|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.42||||0.006||95.0|2.14|12.69|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.69|2.14|0.006
73861345|NCT00394901|147268657|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.15||||0.117||95.0|-1.05|9.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.34|-1.05|0.117
73861346|NCT00394901|147268658|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.99||||0.154||95.0|-1.5|9.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05||9.49|-1.50|0.154
73861347|NCT00394901|147268658|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.99||||0.012||95.0|1.58|12.4|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.40|1.58|0.012
73861348|NCT00394901|147268658|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.76||||0.079||95.0|-0.56|10.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.08|-0.56|0.079
73861349|NCT00394901|147268659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.6451||95.0|0.45|3.59|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.59|0.45|0.6451
73861350|NCT00394901|147268659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.56||||0.0745||95.0|0.91|7.19|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.19|0.91|0.0745
73861351|NCT00394901|147268659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.01||||0.1787||95.0|0.73|5.58|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.58|0.73|0.1787
73861352|NCT00394901|147268660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.0732||95.0|0.93|5.52|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.52|0.93|0.0732
73861353|NCT00394901|147268660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.64||||0.0353||95.0|1.07|6.53|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.53|1.07|0.0353
73861354|NCT00394901|147268660|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.5||||0.0393||95.0|1.05|5.96|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.96|1.05|0.0393
73861355|NCT00394901|147268661|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.227||95.0|-0.78|0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.18|-0.78|0.227
73861356|NCT00394901|147268661|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86|||<|0.001||95.0|-1.34|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.38|-1.34|<0.001
73861357|NCT00394901|147268661|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|||<|0.001||95.0|-1.4|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.40|<0.001
73966934|NCT04549168|147470788|SUPERIORITY||LSM difference|-17.84||||0.0002|TWO_SIDED|95.0|-27.16|-8.51||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||-8.51|-27.16|0.0002
73966935|NCT04549168|147470789|SUPERIORITY||LS geometric mean ratio|0.776||||0.0063|TWO_SIDED|95.0|0.647|0.93||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||0.930|0.647|0.0063
74027883|NCT02042131|147609300|SUPERIORITY||Cox Proportional Hazard|0.24||||0.04|TWO_SIDED|95.0|0.06|0.96|||Regression, Cox|||Planned contrast #1: TAU vs. S-CRP/E-CRP||0.96|0.06|.040
73861358|NCT00394901|147268662|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.577||95.0|-0.62|0.35|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.35|-0.62|0.577
73861359|NCT00394901|147268662|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.39|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.39|-1.35|<0.001
73861360|NCT00394901|147268662|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.27|-1.22|0.002
73861361|NCT00394901|147268663|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27||||0.275||95.0|-0.75|0.21|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.21|-0.75|0.275
73861362|NCT00394901|147268663|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.98|||<|0.001||95.0|-1.46|-0.5|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.50|-1.46|<0.001
73861363|NCT00394901|147268663|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.28|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.22|0.002
73861364|NCT00394901|147268664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.334||95.0|-0.72|0.25|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.25|-0.72|0.334
73861365|NCT00394901|147268664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.001||95.0|-1.38|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.42|-1.38|<0.001
73861366|NCT00394901|147268664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.006||95.0|-1.14|-0.19|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.19|-1.14|0.006
73861367|NCT00394901|147268665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15||||0.53||95.0|-0.64|0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.33|-0.64|0.530
73861368|NCT00394901|147268665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.30|0.001
73861369|NCT00394901|147268665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58||||0.017||95.0|-1.05|-0.1|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.05|0.017
73861370|NCT00394901|147268666|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.392||95.0|-0.7|0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.27|-0.70|0.392
73861371|NCT00394901|147268666|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.38|-1.35|<0.001
73861372|NCT00394901|147268666|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58||||0.016||95.0|-1.06|-0.11|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.11|-1.06|0.016
73861373|NCT00394901|147268667|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22||||0.364||95.0|-0.71|0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.26|-0.71|0.364
73861374|NCT00394901|147268667|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||<|0.001||95.0|-1.39|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.42|-1.39|<0.001
73861375|NCT00394901|147268667|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52||||0.031||95.0|-1.0|-0.05|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-1.00|0.031
73861376|NCT00394901|147268668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.326||95.0|-0.73|0.24|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.24|-0.73|0.326
73861377|NCT00394901|147268668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.43|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.43|<0.001
73861378|NCT00394901|147268668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.007||95.0|-1.13|-0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.13|0.007
74027884|NCT02042131|147609301|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Omnibus test comparing all three groups.||||<0.001
74027885|NCT02042131|147609301|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||<0.001
74086587|NCT04100096|147726639|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.1922|TWO_SIDED|95.0|-0.5|0.1||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 8||0.10|-0.50|0.1922
73919185|NCT02782780|147366237|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(92.1)=2.56||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||<0.01
73919186|NCT02782780|147366238|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||=|0.991|||||||Mixed Models Analysis|Test of treatment effect: t(110)=-0.41||||||=0.991
74086588|NCT04100096|147726639|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.6488|TWO_SIDED|95.0|-0.4|0.25||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 10||0.25|-0.40|0.6488
73861379|NCT00394901|147268669|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.241||95.0|-0.78|0.2|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.20|-0.78|0.241
73861380|NCT00394901|147268669|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.001||95.0|-1.34|-0.37|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.37|-1.34|0.001
73919187|NCT02782780|147366238|SUPERIORITY||||||=|0.41||||||Baseline vs. 6-month follow-up in CBTi group: t(91.8)=0.94|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||=0.41
73919188|NCT02782780|147366239|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.05|||||||Mixed Models Analysis|Test of treatment effect: t(83.7)=2.51||||||<0.05
73919189|NCT02782780|147366239|SUPERIORITY||||||=|0.49||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(90.9)=0.27||||||=0.49
73919190|NCT02782780|147366240|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.01|||||||Mixed Models Analysis|test of treatment effect: t(105)=4.55||||||<0.01
73919191|NCT02782780|147366240|SUPERIORITY||||||<|0.01||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(91.3)=3.23||||||<0.01
73919192|NCT02782780|147366241|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(91.6)=3.37||||||<0.001
73919193|NCT02782780|147366241|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: (92.1)=3.64|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
73919194|NCT02782780|147366242|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(99.2)=5.45||||||<0.001
73919195|NCT02782780|147366242|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(93.4)=6.06|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
73919196|NCT02782780|147366243|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|test of treatment effect: t(76.9)=-4.20||||||<0.001
73919197|NCT02782780|147366243|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(33.1)=6.52|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
74027886|NCT02042131|147609302|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||<0.001
74027887|NCT02042131|147609303|SUPERIORITY|||||||0.04|||||||Chi-squared|||Omnibus test of all groups||||0.040
74027888|NCT02042131|147609303|SUPERIORITY||Odds Ratio (OR)|0.1||||0.045|TWO_SIDED|95.0|0.002|0.9|||Chi-squared|||Planned contrast #2: E-CRP vs. TAU/S-CRP||0.9|0.002|0.045
74027889|NCT00377299|147609333|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||0.05
74027890|NCT00377299|147609334|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
74086589|NCT04100096|147726639|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.5992|TWO_SIDED|95.0|-0.4|0.23||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 12||0.23|-0.40|0.5992
74086590|NCT04100096|147726640|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6579|TWO_SIDED|95.0|-0.29|0.19||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 2||0.19|-0.29|0.6579
73966936|NCT04549168|147470790|SUPERIORITY||LSM difference|4.49||||0.0242|TWO_SIDED|95.0|0.59|8.39||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||8.39|0.59|0.0242
73919198|NCT02782780|147366244|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(75.6)=4.33||||||<0.001
73919199|NCT02782780|147366244|SUPERIORITY||||||<|0.001||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(34.4)=4.75||||||<0.001
73919200|NCT02782780|147366245|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(75.1)=3.91||||||<0.001
73919201|NCT02782780|147366245|SUPERIORITY||||||<|0.001||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month in CBTi group: t(34.5)=4.39||||||<0.001
73919202|NCT03562481|147366246|EQUIVALENCE|Analysis of variance for a 2x2 crossover study implemented using the pkcross routine of Stata 16.1, accounting of sequence and period effects.|F statistic|0.8||||0.38|TWO_SIDED|||||The threshold for statistical significance p\<0.05|ANOVA|Analysis of variance for a 2x2 crossover study implemented using the pkcross routine of Stata 16.1, accounting of sequence and period effects.||||||0.38
73919203|NCT03562481|147366247|EQUIVALENCE|Equivalence was defined as a non-statistically significant difference.|F statistic|1.21||||0.28|TWO_SIDED|||||The threshold for statistical significance p\<0.05|ANOVA|||Analysis of variance for 2x2 crossover study using the pkcross routine of Stata 16.1 and accounting for sequence and period effects.||||0.28
73919204|NCT03562481|147366248|EQUIVALENCE|Equivalence was defined based on statistical significance in the cross-over ANOVA.|F statistic|11.1||||0.003|TWO_SIDED|||||This is adjusted for period and sequence effects and is statistically significant at the p\<0.05 level.|ANOVA|||Analysis of variance for 2x2 crossover study using the pkcross routine of Stata 16.1 adjusting for perio and sequence effects.||||0.003
73919205|NCT03562481|147366249|EQUIVALENCE|Equivalence was determined based on the statistical significance of the Wilcoxon signed-rank test.|Z score|-0.996||||0.33|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sign test|Wilcoxon signed-rank test||||||0.33
73919206|NCT03562481|147366250|EQUIVALENCE|Equivalence was determined based on the statistical significance of the chi square test.|Chi-square test|0.81||||0.37|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Chi-squared|||||||0.37
73919207|NCT03562481|147366251|EQUIVALENCE|Equivalence was defined based on statistical significance in the symmetry test.|Chi-square test|0.2||||0.65|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Stuart-Maxwell test of marginal homogeneity implemented with the symmetry routine in Stata 16.1||||0.65
73919208|NCT03562481|147366252|EQUIVALENCE|Equivalence was defined based on significance in the symmetry test.|Chi-square test|0.14||||0.71|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Test of symmetry or marginal homogeneity (Stuart-Maxwell) implemented with the symmetry routine in Stata 16.1.||||0.71
73919209|NCT03562481|147366253|EQUIVALENCE|Equivalence was defined based on statistical significance in the symmetry test.|Chi-square test|1.0||||0.32|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Test of symmetry (marginal homogeneity, Stuart-Maxwell) implemented using the symmetry routine in Stata 16.1.||||0.32
73919210|NCT03562481|147366254|EQUIVALENCE|Equivalence was defined based on the statistical significance of the symmetry test.|Chi-square test|1.29||||0.26|TWO_SIDED||||||Sruart-Maxwell symmetry test|||Test of symmetry (marginal homogeneity, Stuart-Maxwell) implemented using the symmetry routine in Stata 16.1.||||0.26
73919211|NCT01077856|147366279|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|1.34|||||TWO_SIDED|95.0|0.89|2.0|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||2.00|0.89|
73919212|NCT01077856|147366279|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|1.59|||||TWO_SIDED|95.0|0.0|4.77|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||4.77|0.00|
73919213|NCT01077856|147366279|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|0.86|||||TWO_SIDED|95.0|0.0|2.02|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||2.02|0.00|
73966937|NCT04549168|147470791|SUPERIORITY||LSM difference|-10.36||||0.1625|TWO_SIDED|95.0|-24.95|4.22||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||4.22|-24.95|0.1625
73966938|NCT04549168|147470792|SUPERIORITY||LS geometric mean ratio|0.815||||0.0515|TWO_SIDED|95.0|0.663|1.001||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||1.001|0.663|0.0515
74027891|NCT00377299|147609335|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
74027892|NCT00377299|147609336|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
74027893|NCT00377299|147609337|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
74027894|NCT03461965|147609338|OTHER|p-value \< 0.05 was considered statistically significant||||||0.007|||||||t-test, 2 sided|||Comparing total responses that were correct across all participants in both arms||||0.007
74027895|NCT03461965|147609339|OTHER|p-value \< 0.05 was considered statistically significant||||||0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||0.0001
74027896|NCT03461965|147609339|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.03|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.03
74027897|NCT03461965|147609339|OTHER|p-value \< 0.05 was considered statistically significant||||||0.352|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.352
73919214|NCT03950167|147366284|OTHER||Mean Difference (Final Values)|0.85||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting CCK level difference: hyperemesis group-control group|||||0.05
73919215|NCT03950167|147366284|OTHER||Mean Difference (Net)|0.68||||0.05|TWO_SIDED||||||t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial CCK level difference: hyperemesis group-control group|Since this is the first study comparing both CCK levels and GB functions in patients diagnosed with hyperemesis gravidarum (HG) and healthy pregnant women, a power analysis was not feasible.||||0.05
73919216|NCT03950167|147366285|OTHER||Mean Difference (Final Values)|0.91||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB wall thickness: Hyperemesis group-control group|||||0.05
73919217|NCT03950167|147366285|OTHER||Mean Difference (Final Values)|0.23||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB wall thickness: hyperemesis group-control group|||||0.05
73919218|NCT03950167|147366286|OTHER||Mean Difference (Final Values)|0.41||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB volume: hyperemesis group-control group|||||0.05
73919219|NCT03950167|147366286|OTHER||Mean Difference (Final Values)|0.71||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB volume: hyperemesis group-control group|||||0.05
73919220|NCT03950167|147366287|OTHER||Mean Difference (Final Values)|0.22||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB ejection fraction: hyperemesis group-control group|||||0.05
73919221|NCT03950167|147366287|OTHER||Mean Difference (Final Values)|0.63||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB ejection fraction: hyperemesis group-control group|||||0.05
73919222|NCT03247530|147366288|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.61||0.0004|TWO_SIDED|95.0|-8.9|-2.6|||Mixed Models for Repeated Measures|||||-2.6|-8.9|0.0004
73919223|NCT03247530|147366288|SUPERIORITY||Least Square Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|-10.0|-3.8|||Mixed Models for Repeated Measures|||||-3.8|-10.0|<0.0001
73919224|NCT03247530|147366289|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.7|0.0020
73919225|NCT03247530|147366289|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.3|-0.8|<0.0001
73919226|NCT03247530|147366290|SUPERIORITY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.16||0.0003|TWO_SIDED|95.0|-6.5|-1.9|||ANCOVA|||||-1.9|-6.5|0.0003
73919227|NCT03247530|147366290|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.15||0.0002|TWO_SIDED|95.0|-6.6|-2.1|||ANCOVA|||||-2.1|-6.6|0.0002
73919228|NCT03247530|147366291|SUPERIORITY||Least Square Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.047||0.0019|TWO_SIDED|95.0|-0.24|-0.05|||ANCOVA|||||-0.05|-0.24|0.0019
73919229|NCT03247530|147366291|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.046||0.002|TWO_SIDED|95.0|-0.26|-0.08|||ANCOVA|||||-0.08|-0.26|0.0020
73919230|NCT03247530|147366292|SUPERIORITY||Risk Difference (RD)|14.5||||0.0063|TWO_SIDED|95.0|4.3|24.6|||Regression, Logistic|||||24.6|4.3|0.0063
73919231|NCT03247530|147366292|SUPERIORITY||Risk Difference (RD)|21.5|||<|0.0001|TWO_SIDED|95.0|11.3|31.6|||Regression, Logistic|||||31.6|11.3|<0.0001
73919232|NCT03247530|147366293|SUPERIORITY||Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.63||0.9974|TWO_SIDED|95.0|-4.5|4.5|||ANCOVA|||||4.5|-4.5|0.9974
73919233|NCT03247530|147366293|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.26||0.4557|TWO_SIDED|95.0|-6.1|2.7|||ANCOVA|||||2.7|-6.1|0.4557
73919234|NCT03247530|147366294|SUPERIORITY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.85||0.0006|TWO_SIDED|95.0|-4.6|-1.2|||ANCOVA|||This statistical analysis pertains to the Inattention subscale score||-1.2|-4.6|0.0006
73919235|NCT03247530|147366294|SUPERIORITY||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-5.2|-1.9|||ANCOVA|||This statistical analysis pertains to the Inattention subscale score||-1.9|-5.2|<0.0001
73919236|NCT03247530|147366294|SUPERIORITY||Least Square Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.83||0.0026|TWO_SIDED|95.0|-4.1|-0.9|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.9|-4.1|0.0026
73919237|NCT03247530|147366294|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-4.8|-1.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.7|-4.8|<0.0001
74027898|NCT03461965|147609340|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
74027899|NCT03461965|147609340|OTHER|p-value \< 0.05 was considered statistically significant||||||0.04|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||0.04
74027900|NCT03461965|147609340|OTHER|p-value \< 0.05 was considered statistically significant||||||0.052|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.052
74027901|NCT03461965|147609341|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
74027902|NCT03461965|147609341|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
73919238|NCT03247530|147366295|SUPERIORITY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.1292|TWO_SIDED|95.0|-4.2|0.5|||ANCOVA|||||0.5|-4.2|0.1292
74086591|NCT04100096|147726640|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3728|TWO_SIDED|95.0|-0.43|0.16||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 4||0.16|-0.43|0.3728
73861381|NCT00394901|147268669|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.01||95.0|-1.1|-0.15|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.15|-1.10|0.010
73861382|NCT00394901|147268670|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27||||0.281||95.0|-0.76|0.22|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.22|-0.76|0.281
73861383|NCT00394901|147268670|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.30|0.001
73861384|NCT00394901|147268670|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62||||0.012||95.0|-1.09|-0.14|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.14|-1.09|0.012
73861385|NCT05028517|147268684|SUPERIORITY||ANOVA Omnibus F test|0.511||||0.602|TWO_SIDED||||||ANOVA|||||||.602
73861386|NCT05028517|147268685|SUPERIORITY||ANOVA Omnibus F test|1.245||||0.294|TWO_SIDED||||||ANOVA|||||||.294
73861387|NCT05028517|147268686|SUPERIORITY||Anova Omnibus F test|2.585||||0.039|TWO_SIDED||||||ANOVA|||||||.039
73861388|NCT05028517|147268687|SUPERIORITY||Anova Omnibus F test|2.723||||0.032|TWO_SIDED||||||ANOVA|||||||0.032
73861389|NCT05028517|147268688|SUPERIORITY||Anova Omnibus F test|0.588||||0.672|TWO_SIDED||||||ANOVA|||||||0.672
73861390|NCT05028517|147268689|SUPERIORITY||Anova Omnibus F test|2.612||||0.038|TWO_SIDED||||||ANOVA|||||||0.038
73861391|NCT05028517|147268690|SUPERIORITY||Anova Omnibus F test|0.196||||0.94|TWO_SIDED||||||ANOVA|||||||.940
73861392|NCT05028517|147268691|SUPERIORITY||Anova Omnibus F test|0.59||||0.671|TWO_SIDED||||||ANOVA|||||||.671
73861393|NCT05028517|147268692|SUPERIORITY||Anova Omnibus F test|0.896||||0.468|TWO_SIDED||||||ANOVA|||||||.468
73861394|NCT05028517|147268693|SUPERIORITY||Anova Omnibus F test|3.42||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
73861395|NCT05028517|147268694|SUPERIORITY||Anova Omnibus F test|1.384||||0.257|TWO_SIDED||||||ANOVA|||||||.257
73861396|NCT05028517|147268695|SUPERIORITY||Anova Omnibus F test|1.686||||0.192|TWO_SIDED||||||ANOVA|||||||.192
73861397|NCT05028517|147268696|SUPERIORITY||Anova Omnibus F test|0.651||||0.524|TWO_SIDED||||||ANOVA|||||||.524
73861398|NCT05028517|147268697|SUPERIORITY||Anova Omnibus F test|1.32||||0.255|TWO_SIDED||||||ANOVA|||||||.255
73919239|NCT03247530|147366295|SUPERIORITY||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.19||0.3447|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|||||1.2|-3.4|0.3447
73861399|NCT02256267|147268698|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.0771|||||TWO_SIDED|90.0|0.0671|0.0886||||||||0.0886|0.0671|
73861400|NCT02256267|147268699|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.0467|||||TWO_SIDED|90.0|0.0376|0.0581||||||||0.0581|0.0376|
73861401|NCT02818114|147268701|OTHER|Assessment of number of PE sessions attended, review of direction of change in PTSD Checklist scores||||||||||||||||This is a single-arm feasibility study. With N=8, formal hypothesis testing is not possible. We were assessing the extent to which veterans would be willing to engage in the intervention, and if the direction of change in symptoms is still in the expected direction when peer support services are added. Outcomes are reported more qualitatively.|As a feasibility trial, tests of statistical significance are not appropriate.|||
73861402|NCT02360293|147268706|SUPERIORITY||Slope|1.88|STANDARD_ERROR_OF_MEAN|46.2|||TWO_SIDED|95.0|-119.0|122.7|||||Generated through ANCOVA predicting Active Minutes as a function of arm and f/u time, adjusted for Sex, Baseline PA Goal (AM), and type of Smart Phone. Represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|Estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA, adjusted for baseline AM goal, Type of Smart Phone, and Sex.||122.7|-119.0|
73861403|NCT02360293|147268707|SUPERIORITY||Slope|-5.02|STANDARD_ERROR_OF_MEAN|56.7|||TWO_SIDED|95.0|-15.85|5.81|||||Generated through ANCOVA predicting Weight as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||5.81|-15.85|
73861404|NCT02360293|147268708|SUPERIORITY||Slope|-1.162|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.969|0.646|||||Generated through ANCOVA predicting PHQ-8 Score as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||0.646|-2.969|
74088447|NCT00107042|147730255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||1|TWO_SIDED|95.0|0.0|10.01|||Univariate regression, Logistic||"The reference group is the 0 Partners group"|||10.01|0.00|1.0000
73861405|NCT02360293|147268709|SUPERIORITY||Slope|-0.345|STANDARD_ERROR_OF_MEAN|0.267|||TWO_SIDED|95.0|-1.044|0.353|||||"Estimate generated through ANCOVA predicting Pain In Past Week as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.."|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||0.353|-1.044|
73861406|NCT01498185|147268717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|18.5425|||TWO_SIDED|95.0|-40.85|35.86||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||35.86|-40.85|
73919240|NCT03247530|147366296|SUPERIORITY|||||||0.0005|||||||Chi-squared|||This analysis pertains to Week 1 of treatment||||0.0005
73919241|NCT03247530|147366296|SUPERIORITY|||||||0.0212|||||||Chi-squared|||This analysis pertains to Week 2 of treatment||||0.0212
73919242|NCT03247530|147366296|SUPERIORITY|||||||0.0115|||||||Chi-squared|||This analysis pertains to Week 3 of treatment||||0.0115
74086592|NCT04100096|147726640|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.1684|TWO_SIDED|95.0|-0.5|0.09||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 6||0.09|-0.50|0.1684
73919243|NCT03247530|147366296|SUPERIORITY|||||||0.0027|||||||Chi-squared|||This analysis pertains to Week 4 of treatment||||0.0027
73919244|NCT03247530|147366296|SUPERIORITY|||||||0.0066|||||||Chi-squared|||This analysis pertains to Week 5 of treatment||||0.0066
73919245|NCT03247530|147366296|SUPERIORITY|||||||0.0065|||||||Chi-squared|||This analysis pertains to Week 6 of treatment||||0.0065
73919246|NCT03247530|147366296|SUPERIORITY|||||||0.5826|||||||Chi-squared|||This analysis pertains to Week 1 of treatment||||0.5826
73919247|NCT03247530|147366296|SUPERIORITY|||||||0.0099|||||||Chi-squared|||This analysis pertains to Week 2 of treatment||||0.0099
73919248|NCT03247530|147366296|SUPERIORITY|||||||0.0225|||||||Chi-squared|||This analysis pertains to Week 3 of treatment||||0.0225
73919249|NCT03247530|147366296|SUPERIORITY|||||||0.0008|||||||Chi-squared|||This analysis pertains to Week 4 of treatment||||0.0008
73919250|NCT03247530|147366296|SUPERIORITY|||||||0.002|||||||Chi-squared|||This analysis pertains to Week 5 of treatment||||0.0020
73919251|NCT03247530|147366296|SUPERIORITY|||||||0.0002|||||||Chi-squared|||This analysis pertains to Week 6 of treatment||||0.0002
73919252|NCT01442493|147366298|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
73919253|NCT01442493|147366299|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
73919254|NCT01442493|147366300|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
73919255|NCT01442493|147366301|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
73919256|NCT01442493|147366302|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
73919257|NCT01442493|147366303|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
73919258|NCT01442493|147366304|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
73919259|NCT03315208|147366316|SUPERIORITY||Chi-squared statistic value|0.23||||0.63|TWO_SIDED||||||Chi-squared, Corrected|df=1||||||0.63
73919260|NCT03315208|147366317|SUPERIORITY||Slope|0.72||||0.29|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.29
73919261|NCT03315208|147366318|SUPERIORITY||Slope|-0.56||||0.5|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||.50
73919262|NCT03315208|147366319|SUPERIORITY||Slope|-1.96||||0.45|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. BSI scores were binarized (0 and \>=1) for this analysis due to the non-normal distribution of this outcome.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.45
73919263|NCT03315208|147366321|SUPERIORITY||Slope|-0.19||||0.76|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.76
73919264|NCT03315208|147366322|SUPERIORITY||Slope|-1.07||||0.21|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. Due to the non-normal distribution of the Craving Scale, scores on this measure were binarized (\< 15 and \>= 15) for this analysis.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||.21
73966939|NCT04549168|147470793|SUPERIORITY||LSM difference|7.74|||<|0.0001|TWO_SIDED|95.0|5.61|9.86||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||9.86|5.61|<0.0001
74086593|NCT04100096|147726640|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.0046|TWO_SIDED|95.0|-0.74|-0.13||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 8||-0.13|-0.74|0.0046
73919265|NCT03315208|147366323|SUPERIORITY||t statistic|0.29||||0.77|TWO_SIDED||||||t-test, 2 sided|||Due to the non-normal distribution of the PDA variable, this variable was treated as binary (\<50% and \>=50%) for mixed models; however, due to the small numbers of participants (\< 5) in certain cells of treatment condition (UP versus TAU) by time point, we ran into issues with convergence of linear mixed models. Thus, here we report the results from an independent samples t-test of means (percentage of past 30 days abstinent) at post-treatment (UP versus TAU).||||0.77
73919266|NCT02320149|147366341|SUPERIORITY||Least Squares Mean Difference|-5.2|||<|0.0001|TWO_SIDED|95.0|-6.7|-3.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|||-3.6|-6.7|< 0.0001
73919267|NCT02320149|147366342|SUPERIORITY||Treatment Rate Difference|11.05|||<|0.0001|TWO_SIDED|95.0|6.39|15.72||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo|||15.72|6.39|< 0.0001
73919268|NCT02320149|147366343|SUPERIORITY||Least Squares Mean Difference|-16.7|||<|0.0001|TWO_SIDED|95.0|-21.9|-11.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||-11.6|-21.9|< 0.0001
73919269|NCT02320149|147366344|SUPERIORITY||Least Squares Mean Difference|-12.5|||<|0.0001||95.0|-16.9|-8.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||-8.0|-16.9|< 0.0001
73919270|NCT02320149|147366345|SUPERIORITY||Least Squares Mean Difference|-13.3|||<|0.0001|TWO_SIDED|95.0|-17.5|-9.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||-9.1|-17.5|< 0.0001
73919271|NCT02320149|147366346|SUPERIORITY||Least Squares Mean Difference|-7.2||||0.0003|TWO_SIDED|95.0|-11.1|-3.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||-3.3|-11.1|0.0003
73919272|NCT02320149|147366347|SUPERIORITY||Least Squares Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-2.5|-5.3|< 0.0001
73919273|NCT02320149|147366348|SUPERIORITY||Least Squares Mean Difference|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.4|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-2.9|-5.4|< 0.0001
73919274|NCT02320149|147366349|SUPERIORITY||Least Squares Mean Difference|-2.1||||0.0005|TWO_SIDED|95.0|-3.3|-0.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||-0.9|-3.3|0.0005
73919275|NCT02320149|147366350|SUPERIORITY||Least Squares Mean Difference|-4.3||||0.5786|TWO_SIDED|95.0|-19.4|10.8||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||10.8|-19.4|0.5786
73919276|NCT02320149|147366351|SUPERIORITY||Least Squares Mean Difference|-2.8||||0.6969|TWO_SIDED|95.0|-17.1|11.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||11.4|-17.1|0.6969
73919277|NCT02320149|147366352|SUPERIORITY||Least Squares Mean Difference|3.0||||0.7377|TWO_SIDED|95.0|-14.7|20.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||20.7|-14.7|0.7377
73919278|NCT02320149|147366353|SUPERIORITY||Least Squares Mean Difference|6.4||||0.2861|TWO_SIDED|95.0|-5.3|18.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||18.1|-5.3|0.2861
73919279|NCT02320149|147366354|SUPERIORITY||Least Squares Mean Difference|-3.9||||0.0014|TWO_SIDED|95.0|-6.3|-1.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 12||-1.5|-6.3|0.0014
73919280|NCT02320149|147366355|SUPERIORITY||Least Squares Mean Difference|-3.4||||0.001|TWO_SIDED|95.0|-5.5|-1.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-1.4|-5.5|0.0010
73919281|NCT02320149|147366356|SUPERIORITY||Least Squares Mean Difference|-2.0||||0.0371|TWO_SIDED|95.0|-4.0|-0.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-0.1|-4.0|0.0371
73919282|NCT02320149|147366357|SUPERIORITY||Least Squares Mean Difference|-0.8||||0.3806|TWO_SIDED|95.0|-2.5|1.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||1.0|-2.5|0.3806
73919283|NCT01156311|147366369|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.17|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.||-0.33|-1.17|<0.0001
74027903|NCT03461965|147609341|OTHER|p-value \< 0.05 was considered statistically significant||||||0.208|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.208
74027904|NCT03461965|147609342|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.03|||||||Chi-squared|||||||<0.03
74088448|NCT00107042|147730256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.5503|TWO_SIDED|95.0|0.05|4.86|||Univariate regression, logistic||"The reference group is the 0 Partners group"|||4.86|0.05|0.5503
73919284|NCT01156311|147366369|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.17||||0.0124|TWO_SIDED|95.0|-1.83|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.||-0.33|-1.83|0.0124
73919285|NCT01156311|147366370|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.001|TWO_SIDED|95.0|-1.5|-0.25|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.||-0.25|-1.50|0.0010
74086594|NCT04100096|147726640|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.2087|TWO_SIDED|95.0|-0.51|0.11||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 10||0.11|-0.51|0.2087
74086595|NCT04100096|147726640|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0389|TWO_SIDED|95.0|-0.64|-0.02||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 12||-0.02|-0.64|0.0389
73919286|NCT01156311|147366370|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.0339|TWO_SIDED|95.0|-1.25|0.0|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.||0.00|-1.25|0.0339
73919287|NCT01741701|147366372|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
73919288|NCT01741701|147366373|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||Comparison of change between groups from baseline to 4 months||||0.51
73919289|NCT01741701|147366374|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months||||0.97
73919290|NCT01741701|147366375|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months||||.77
73919291|NCT01741701|147366376|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months||||.90
73919292|NCT01741701|147366377|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months||||.95
73919293|NCT01669915|147366378|SUPERIORITY||Mean Difference (Net)|0.01||||0.31|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.02|-0.01|0.31
73919294|NCT01669915|147366378|SUPERIORITY||Mean Difference (Net)|-0.01||||0.14|TWO_SIDED|95.0|-0.02|0.003|||Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 fatty acids active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.003|-0.02|0.14
73919295|NCT01669915|147366379|SUPERIORITY||Mean Difference (Net)|0.01||||0.49|TWO_SIDED|95.0|-0.01|0.03||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.03|-0.01|0.49
73919296|NCT01669915|147366379|SUPERIORITY||Mean Difference (Net)|-0.02||||0.03|TWO_SIDED|95.0|-0.04|-0.002||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||-0.002|-0.04|0.03
73919297|NCT01669915|147366380|SUPERIORITY||Mean Difference (Net)|0.01||||0.23|TWO_SIDED|95.0|-0.01|0.02||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.02|-0.01|0.23
73919298|NCT01669915|147366380|SUPERIORITY||Mean Difference (Net)|0.003||||0.68|TWO_SIDED|95.0|-0.01|0.02||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization)||0.02|-0.01|0.68
73919299|NCT01669915|147366381|SUPERIORITY||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.04|0.09||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.09|-0.04|0.46
73966940|NCT04549168|147470794|SUPERIORITY||LSM difference|-21.25|||<|0.0001|TWO_SIDED|95.0|-28.15|-14.35||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||-14.35|-28.15|<0.0001
74088449|NCT00107042|147730256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8904|TWO_SIDED|95.0|0.13|10.46|||Univariate Regression, Logistic||"The reference group is the 0 Partners group."|||10.46|0.13|0.8904
74088450|NCT00107042|147730257|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.301|TWO_SIDED|95.0|0.12|1.92|||Univariate regression, logistic||"The reference group is the Ever drank alcohol: NO group."|||1.92|0.12|0.3010
73919300|NCT01669915|147366381|SUPERIORITY||Mean Difference (Net)|-0.1||||0.003|TWO_SIDED|95.0|-0.17|-0.04||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||-0.04|-0.17|0.003
73919301|NCT02648178|147366400|OTHER|We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, by week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), Nicotine, Cotinine, Hydro and Creatinine and CO (Carbon Monoxide) level,by week and their interactions.||||||||||||We tested whether there were significant associations between cigarette smoking and e-cigarette smoking, as well as whether there were significant associations between biomarkers mentioned above with CO level.||We provided estimated values of coefficients from model and their 95% confidence intervals.|||We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL, Nicotine, Cotinine, Hydro and Creatinine and CO level, week and their interactions.|||
73919302|NCT01285310|147366431|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-7.4||||0.3134|TWO_SIDED|95.0|-27.1|7.0|||Chi-squared||2-sided 95% CI of the proportion difference is based on a normal approximation to the binomial distribution|Significance testing was done using the following closed procedure; if the overall test among treatments is statistically significant at the 0.05 level, pair-wise comparisons (30 mg versus PBO, and 20 mg versus PBO, using a 0.05 two-sided significance level) will be performed||7.0|-27.1|0.3134
73919303|NCT01285310|147366431|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.2||||0.8721|TWO_SIDED|95.0|-16.2|13.8|||Chi-squared||2-sided 95% CI is based on a normal approximation to the binomial distribution|||13.8|-16.2|0.8721
73919304|NCT01285310|147366432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.004|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919305|NCT01285310|147366432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.091|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919306|NCT01285310|147366433|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-4.5||||||||||||||||||
73919307|NCT01285310|147366433|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.6||||||||||||||||||
73919308|NCT01285310|147366434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.007||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
73919309|NCT01285310|147366434|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.15|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, treatment group as a factor and the baseline value as a covariate.|||||
73919310|NCT01285310|147366435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate|||||
73919311|NCT01285310|147366435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate.|||||
73919312|NCT01285310|147366436|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.21||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate.||||||
73919313|NCT01285310|147366436|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
74086596|NCT04100096|147726645|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.272|TWO_SIDED|95.0|-0.14|0.5||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 2||0.50|-0.14|0.2720
73919314|NCT01285310|147366437|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.5||||||||||||||||||
73919315|NCT01285310|147366437|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-7.2||||||||||||||||||
73919316|NCT01285310|147366438|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, treatment group as a factor and the baseline value as a covariate.||||||
73919317|NCT01285310|147366438|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.02|||||TWO_SIDED|||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
73919318|NCT01285310|147366439|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.15|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
73919319|NCT01285310|147366439|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
73919320|NCT01285310|147366440|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.58|||||TWO_SIDED||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919321|NCT01285310|147366440|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.26||||||||||||||||||
73919322|NCT01285310|147366441|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-35.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
74086597|NCT04100096|147726645|SUPERIORITY||Mean Difference (Final Values)|1.09||||0|TWO_SIDED|95.0|0.63|1.56||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 4||1.56|0.63|0
74088451|NCT00107042|147730258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.0501|TWO_SIDED|95.0|0.06|1.0|||Univariate regression, logistic||"The reference group is the Ever smoked marijuana: NO group."|||1.00|0.06|0.0501
74088452|NCT00107042|147730259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.3846|TWO_SIDED|95.0|0.04|3.61|||Univariate regression, logistic||"The reference group is the Ever used drugs not prescribed: NO group."|||3.61|0.04|0.3846
73861407|NCT01498185|147268717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|16.7228|||TWO_SIDED|95.0|-35.36|33.82||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||33.82|-35.36|
73861408|NCT01498185|147268717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.88|STANDARD_ERROR_OF_MEAN|17.1548|||TWO_SIDED|95.0|-42.21|28.45||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||28.45|-42.21|
73861409|NCT01498185|147268717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|18.4617|||TWO_SIDED|95.0|-39.22|37.16||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||37.16|-39.22|
73861410|NCT02725593|147268727|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.45||0.101|TWO_SIDED|95.0|-1.65|0.15|||Mixed model repeated measures analysis|||||0.15|-1.65|0.101
73861411|NCT02725593|147268728|SUPERIORITY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.81||0.34|TWO_SIDED|95.0|-2.42|0.85|||Mixed model repeated measures analysis|||||0.85|-2.42|0.340
73861412|NCT02725593|147268729|SUPERIORITY||Mean Difference (Final Values)|-3.96||||0.655|TWO_SIDED|95.0|-20.11|9.62|||Fisher's exact test|||||9.62|-20.11|0.655
73861413|NCT02725593|147268730|SUPERIORITY||Mean Difference (Final Values)|20.83||||0.056|TWO_SIDED|95.0|0.5|41.11|||Fisher's exact test|||||41.11|0.50|0.056
73861414|NCT03809910|147268746|SUPERIORITY||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|-0.09|-0.04||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.04|-0.09|<.0001
73861415|NCT03809910|147268747|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.17|-0.07||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.07|-0.17|<0.0001
73861416|NCT03809910|147268748|SUPERIORITY||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.16|-0.06||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.06|-0.16|<0.0001
73861417|NCT03809910|147268749|SUPERIORITY||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|-0.25|-0.19||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.19|-0.25|<0.0001
73861418|NCT03809910|147268750|SUPERIORITY||Adjusted Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.43|-0.33||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.33|-0.43|<0.0001
73861419|NCT03809910|147268751|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.39|-0.29||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.29|-0.39|<0.0001
73861420|NCT03809910|147268752|SUPERIORITY||Adjusted Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.13|0.18||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.18|0.13|<0.0001
73861421|NCT03809910|147268753|SUPERIORITY||Adjusted Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.21|0.31||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.31|0.21|<0.0001
73861422|NCT03809910|147268754|SUPERIORITY||Adjusted Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.18|0.28||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.28|0.18|<0.0001
73861423|NCT03809910|147268755|SUPERIORITY||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.15||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.15|0.09|<0.0001
73861424|NCT03809910|147268755|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.014||0.0214|TWO_SIDED|95.0|-0.06|0.0||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.00|-0.06|0.0214
73861425|NCT03809910|147268756|SUPERIORITY||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.13|0.23||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.23|0.13|<0.0001
73861426|NCT03809910|147268756|SUPERIORITY||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025||0.001|TWO_SIDED|95.0|-0.14|-0.04||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.04|-0.14|0.0010
73861427|NCT03809910|147268757|SUPERIORITY||Adjusted Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.15|0.25||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.25|0.15|<0.0001
74088453|NCT00107042|147730260|SUPERIORITY_OR_OTHER|||||||0.3827||95.0|||||Fisher Exact|||||||0.3827
73919323|NCT01285310|147366441|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-38.37|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919324|NCT01285310|147366442|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-14.35|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919325|NCT01285310|147366442|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919326|NCT01285310|147366443|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.59|||||TWO_SIDED||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919327|NCT01285310|147366443|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-3.84|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919328|NCT01285310|147366444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.93|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919329|NCT01285310|147366444|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
73919330|NCT01285310|147366445|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919331|NCT01285310|147366445|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|58.05||||||||||||||||||
73919332|NCT01285310|147366446|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|7.18|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73966941|NCT04549168|147470796|SUPERIORITY||LSM difference|-2.85|STANDARD_ERROR_OF_MEAN|0.811||0.0006|TWO_SIDED|95.0|-4.45|-1.25||Based on Analysis of Covariance (ANCOVA) model with factors of age group, site, treatment, and the baseline ISI as a covariate.|ANCOVA|||||-1.25|-4.45|0.0006
73919333|NCT01285310|147366446|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-16.19|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919334|NCT01285310|147366447|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
73919335|NCT01285310|147366447|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.1|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
73919336|NCT01285310|147366448|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.9||||||||||||||||||
73919337|NCT01285310|147366448|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.4||||||||||||||||||
73919338|NCT01285310|147366449|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.9||||||||||||||||||
73919339|NCT01285310|147366449|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.9||||||||||||||||||
73919340|NCT01285310|147366450|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.4||||||||||||||||||
73919341|NCT01285310|147366450|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.1||||||||||||||||||
73919342|NCT01285310|147366451|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-6.5||||||||||||||||||
73919343|NCT01285310|147366451|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.2||||||||||||||||||
73919344|NCT01285310|147366452|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.3||||||||||||||||||
73919345|NCT01285310|147366452|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.5||||||||||||||||||
73919346|NCT01285310|147366453|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.5||||||||||||||||||
73919347|NCT01285310|147366453|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.5||||||||||||||||||
73919348|NCT01285310|147366454|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.4|||||TWO_SIDED|||||||||||||
73919349|NCT01285310|147366454|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|1.5|||||TWO_SIDED|||||||||||||
73919350|NCT01285310|147366455|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
73919351|NCT01285310|147366455|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.98|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
73919352|NCT01285310|147366456|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.94||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
73919353|NCT01285310|147366456|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.24||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
73919354|NCT01285310|147366457|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-4.3||||||||||||||||||
73919355|NCT01285310|147366457|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|4.6||||||||||||||||||
73919356|NCT01285310|147366458|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
73919357|NCT01285310|147366458|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
73919358|NCT01285310|147366459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
73966942|NCT04549168|147470797|SUPERIORITY||LSM difference|-1.74|STANDARD_ERROR_OF_MEAN|0.488||0.0005|TWO_SIDED|95.0|-2.7|-0.78||Based on ANCOVA model with factors of age group, site, treatment, and the baseline ISI as a covariate.|ANCOVA|||||-0.78|-2.70|0.0005
73966943|NCT04549168|147470799|SUPERIORITY||LSM difference|0.34||||0.0312|TWO_SIDED|95.0|0.03|0.65||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||First 7 mornings of treatment period|||0.65|0.03|0.0312
73919359|NCT01285310|147366459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.01|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.|||||
73919360|NCT01285310|147366460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.86|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
73919361|NCT01285310|147366460|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-7.02|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
73919362|NCT01285310|147366461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
73919363|NCT01285310|147366461|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-37.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
73919364|NCT01285310|147366462|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-14.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
73919365|NCT01285310|147366462|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-12.5|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
73919366|NCT01285310|147366463|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.85|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
73919367|NCT01285310|147366463|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.8|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
73919368|NCT01285310|147366464|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.57|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
73919369|NCT01285310|147366464|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.72|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
73919370|NCT01285310|147366465|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|8.29|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
73919371|NCT01285310|147366465|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|67.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
73919372|NCT01285310|147366466|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|12.05|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
73919373|NCT01285310|147366466|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
73919374|NCT01285310|147366467|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
73919375|NCT01285310|147366467|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
73966944|NCT04549168|147470799|SUPERIORITY||LSM difference|0.32||||0.146|TWO_SIDED|95.0|-0.11|0.76||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||Last 7 mornings of treatment period|||0.76|-0.11|0.1460
73919376|NCT01285310|147366468|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.4||||||||||||||||||
73919377|NCT01285310|147366468|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.6||||||||||||||||||
73919378|NCT01285310|147366469|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-11.9||||||||||||||||||
73919379|NCT01285310|147366469|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.3||||||||||||||||||
73919380|NCT01285310|147366470|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-11.2||||||||||||||||||
73919381|NCT01285310|147366470|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.0||||||||||||||||||
73919382|NCT01574326|147366504|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.9||||0.001|TWO_SIDED|95.0|-1.44|-0.37|||ANCOVA|Threshold for significance ≤ 0.05.||Primary efficacy endpoint, change from baseline to Week 2 in serum phosphorus, was compared between treatment groups using analysis of covariance (ANCOVA) with baseline phosphorus and screening BSA as covariates and fixed effect for treatment. No center effect was included in the model. The estimate of the treatment difference (Sevelamer Carbonate - Placebo) and its 95% CI were presented. Significance was to be declared if the p-value was ≤0.05.||-0.37|-1.44|0.001
73919383|NCT04044716|147366598|SUPERIORITY|||||||0.048|||||||ANCOVA|age, joint involved in surgery, sex, baseline pain||||||.048
73919384|NCT04044716|147366599|SUPERIORITY|||||||0.29|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline pain||||||0.29
73919385|NCT04044716|147366600|SUPERIORITY|||||||0.64|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline morphine milligram equivalents (MME)||||||0.64
73919386|NCT04044716|147366601|SUPERIORITY|||||||0.86|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline MME, and time in hospital||||||0.86
73919387|NCT04044716|147366602|SUPERIORITY|||||||0.661||||||adjusted for age, type of surgery (joint), and sex|ANCOVA|||||||0.661
73919388|NCT01324999|147366617|OTHER|||||||0.68|||||||t-test, 2 sided|||Comparing baseline to week 24.||||0.68
73919389|NCT01324999|147366618|OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
73919390|NCT01324999|147366619|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
73919391|NCT01324999|147366620|OTHER|||||||0.19|||||||t-test, 2 sided|||comparing baseline to week 24||||0.19
73919392|NCT01324999|147366621|OTHER|||||||0.68|||||||t-test, 2 sided|||Comparing Baseline to week 24.||||0.68
73919393|NCT01324999|147366622|OTHER|||||||0.92|||||||t-test, 2 sided|||comparing baseline to week 24||||0.92
73919394|NCT01324999|147366623|OTHER|||||||0.44|||||||t-test, 2 sided|||comparison of baseline to week 24||||0.44
73966945|NCT04549168|147470799|SUPERIORITY||LSM difference|0.29||||0.1613|TWO_SIDED|95.0|-0.12|0.7||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||First 7 mornings of follow-up period|||0.70|-0.12|0.1613
73966946|NCT04549168|147470799|SUPERIORITY||LSM difference|0.23||||0.2852|TWO_SIDED|95.0|-0.19|0.65||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||Last 7 mornings of follow-up period|||0.65|-0.19|0.2852
73966947|NCT02662062|147470817|OTHER|This is a single arm study looking at a binary value with the hypothesis suggesting it falls within a certain range.||||||||||||||||The null hypothesis is that the addition of pembrolizumab to chemoradiation is not unsafe (percentage of the population experiencing unacceptable toxicity is not \>50%)|A Clopper-Pearson method was used to determine the unacceptable toxicity rate and a 95% confidence interval for this binary outcome measure.|||
74088454|NCT00107042|147730260|SUPERIORITY_OR_OTHER||Responding Rate|81.08|||||TWO_SIDED|95.0|68.84|92.04|||||Response rate=Total number subjects responded/Total number subjects in arm|||92.04|68.84|
73861428|NCT03809910|147268757|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.026||0.1652|TWO_SIDED|95.0|-0.09|0.01||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.01|-0.09|0.1652
73861429|NCT04948307|147268761|SUPERIORITY|||||||0.7326|||||||Chi-squared|||||||0.7326
73861430|NCT04948307|147268762|SUPERIORITY|||||||0.7396|||||||Kolmogorov-Smirnoff|||||||0.7396
73861431|NCT04948307|147268763|SUPERIORITY|||||||0.871|||||||Kolmogorov-Smirnoff|||||||0.8710
73861432|NCT04948307|147268764|SUPERIORITY|||||||0.8816|||||||Kolmogorov-Smirnoff|||||||0.8816
73861433|NCT04948307|147268765|SUPERIORITY|||||||0.5281|||||||Chi-squared|||||||0.5281
73861434|NCT04948307|147268766|SUPERIORITY|||||||0.2996|||||||Chi-squared|||||||0.2996
73861435|NCT04948307|147268770|SUPERIORITY|||||||0.7201|||||||Kolmogorov-Smirnoff|||||||0.7201
73861436|NCT04948307|147268772|OTHER|||||||||||||||||Summary statistics are presented.|Summary statistics are presented|||
73861437|NCT04948307|147268774|OTHER||||||||||||||||||Summary statistics are presented.|||
73861438|NCT03131596|147268775|SUPERIORITY|||||||0.012||||||The p-value is not adjusted and a p-value of \< 0.05 is considered statistically significant.|Chi-squared|||200 patients were eligible and randomised in a 1:1 fashion. 9 patients did not complete the full protocol, resulting in 94 cases in the balloon group and 97 cases in the control group included in the final analysis. Intention-to-treat analysis was conducted.The null hypothesis is the percentage of the patients with reformed uterine adhesion in balloon group will less than the percentage of the patients with reformed uterine adhesion in control group. A Chi-squared analysis was used.||||0.012
73861439|NCT03131596|147268776|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73861440|NCT03131596|147268777|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73861441|NCT03131596|147268778|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
73861442|NCT04411420|147268779|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.169|TWO_SIDED|97.5|-1.55|0.37||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.|||0.37|-1.55|0.169
73861443|NCT04411420|147268780|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.139|TWO_SIDED|97.5|-0.33|1.52||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.|||1.52|-0.33|0.139
73861444|NCT04411420|147268781|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.417|TWO_SIDED|95.0|-1.69|0.72||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.||||0.72|-1.69|0.417
73861445|NCT04411420|147268782|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.409|TWO_SIDED|95.0|-1.37|0.57||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.57|-1.37|0.409
73861446|NCT04411420|147268782|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.899|TWO_SIDED|95.0|-1.04|0.91||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.91|-1.04|0.899
73861447|NCT04411420|147268782|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.946|TWO_SIDED|95.0|-1.01|1.08||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||1.08|-1.01|0.946
73861448|NCT04411420|147268783|SUPERIORITY||Odds Ratio, log|-0.004||||0.992|TWO_SIDED|95.0|-4.62|4.61||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Regression, Logistic|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Odds Ratio calculated for Integrated Sequenced Care Pathway relative to Coordinated Care Management Pathway.|||4.61|-4.62|0.992
73861449|NCT04411420|147268784|SUPERIORITY||Median Difference (Final Values)|-2.67||||0.262|TWO_SIDED|95.0|-7.52|2.18||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|||2.18|-7.52|0.262
73919395|NCT00071513|147366654|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Mean changes in Short Moods and Feelings measure of depression was the unit of analysis.||||<0.05
73919396|NCT00071513|147366654|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||A secondary hypothesis of the study was that attachment to school and/or perceptions of school supportiveness would mediate the effect of the HSTS intervention on depressive symptoms.||||<0.01
73919397|NCT01244425|147366658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||likelihood-ratio chi square test|||||||<0.001
73919398|NCT01244425|147366659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||likelihood ratio chi-square test|||||||<0.001
73919399|NCT01244425|147366660|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||likelihood ratio chi-square test|||||||0.028
73919400|NCT01244425|147366661|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||likelihood ratio chi-square test|||||||0.017
73919401|NCT01244425|147366662|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||likelihood ratio chi-square test|||||||0.293
73919402|NCT01244425|147366663|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||likelihood ratio chi-square test|||||||0.237
73919403|NCT01244425|147366664|SUPERIORITY_OR_OTHER|||||||0.808||95.0|||||likelihood ratio chi-square test|||||||0.808
73919404|NCT02848651|147366724|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3502|TWO_SIDED|90.0|0.54|1.18|||Log Rank|||||1.18|0.54|0.3502
73919405|NCT02848651|147366731|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.1783|TWO_SIDED|90.0|0.4|1.1|||Log Rank|||||1.10|0.40|0.1783
73919406|NCT02848651|147366731|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0358|TWO_SIDED|90.0|0.23|0.85|||Log Rank|||||0.85|0.23|0.0358
74086598|NCT04100096|147726645|SUPERIORITY||Mean Difference (Final Values)|1.18||||0|TWO_SIDED|95.0|0.63|1.73||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 6||1.73|0.63|0
73919407|NCT02848651|147366732|SUPERIORITY||Differences in Rates|13.27||||0.0326|TWO_SIDED|90.0|2.53|24.0|||Cochran-Mantel-Haenszel|||||24.00|2.53|0.0326
73919408|NCT02848651|147366732|SUPERIORITY||Difference in Rates|30.22|||<|0.0001|TWO_SIDED|90.0|14.82|45.62|||Cochran-Mantel-Haenszel|||||45.62|14.82|<0.0001
73919409|NCT02848651|147366732|SUPERIORITY||Differences in Rates|41.37|||<|0.0001|TWO_SIDED|90.0|22.13|60.61|||Cochran-Mantel-Haenszel|||||60.61|22.13|<0.0001
74086599|NCT04100096|147726645|SUPERIORITY||Mean Difference (Final Values)|1.57||||0|TWO_SIDED|95.0|0.92|2.21||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 8||2.21|0.92|0
73919410|NCT06092710|147366748|OTHER|Then, to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected.||||||0.05572|||||||Kruskal-Wallis|||Non-parametric tests on patient sensitivity, given the non-normal distribution, (based on the median of the data) were applied to analyse the diﬀerences between the groups (ST1+ ST2 according to the STATUS3 and STATUS4 classification criteria). To analyse any diﬀerences in sensitivity between patient groups, Kruskal-Wallis tests were applied. In this type of analysis, having a p-value greater than 1% and ideally greater than 5% would indicate the absence of diﬀerences between groups.||||0.05572
73919411|NCT06092710|147366748|OTHER|Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected.|||||<|8e-07|||||||Wilcoxon (Mann-Whitney)|||to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.||||<0.0000008
73919412|NCT06092710|147366748|OTHER|Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.|||||<|1e-07|||||||Wilcoxon (Mann-Whitney)|||to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.||||<0.0000001
73919413|NCT06092710|147366749|SUPERIORITY|||||||1.06e-06||||||Confidence level used: 0.95 Tukey multiple comparisons of means (95% family-wise confidence level)|ANOVA|||Parametric tests on the prediction of patients' pathological status with SFI (Intermediate Final Score) For these analyses, as the SFI score follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value, a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another.||||0.00000106
73919414|NCT06092710|147366749|SUPERIORITY|||||||48||||||Confidence level used: 0.95 Tukey multiple comparisons of means (95% family-wise confidence level)|ANOVA|||"Parametric tests on the prediction of patients' pathological status with SFT score (Final Total score):~For these analyses, as SFT score follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value, a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0000000048
73919415|NCT06092710|147366749|SUPERIORITY||Odds Ratio (OR)|8.73||||7.7e-07|TWO_SIDED||||||Fisher Exact|||"Determination of cut-oﬀ values for SFI:~The Cutoﬀ\_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-oﬀ value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically."||||0.00000077
74086600|NCT04100096|147726645|SUPERIORITY||Mean Difference (Final Values)|1.72||||0|TWO_SIDED|95.0|0.99|2.45||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 10||2.45|0.99|0
74086601|NCT04100096|147726645|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.0002|TWO_SIDED|95.0|0.68|2.19||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||2.19|0.68|0.0002
73966948|NCT02662062|147470818|OTHER|Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||||||||||||||||Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||
73966949|NCT02662062|147470819|OTHER|Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||||||||||||||||Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||
73966950|NCT02662062|147470820|OTHER|Non comparative trial with a single arm|Kaplan Meier Estimate|39.0|||||TWO_SIDED|95.0|17.0||missing upper limit of 95% confidence interval on the survival estimate from Kaplan-Meier estimator due to small number events||||||||17|
73966951|NCT02662062|147470821|OTHER|Kaplan Meier Estimate performed for a 12 month timepoint in a single arm non comparative study|Kaplan Meier Estimate|92.0|||||TWO_SIDED|95.0|72.0|98.0||||||||98|72|
73966952|NCT02662062|147470822|OTHER|Kaplan Meier Estimate of single arm non comparative study|Kaplan Meier Estimate|85.0|||||TWO_SIDED|95.0|64.0|94.0||||||||94|64|
73919416|NCT06092710|147366749|SUPERIORITY||Odds Ratio (OR)|9.37||||6.9e-07|TWO_SIDED||||||Fisher Exact|||"Determination of cut-oﬀ values for SFT:~The Cutoﬀ\_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-oﬀ value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically."||||0.00000069
73966953|NCT02662062|147470823|OTHER|Kaplan Meier estimate at a 12 month timepoint for a single arm non comparative study|Kaplan Meier Estimate|88.0|||||TWO_SIDED|95.0|68.0|98.0||||||||98|68|
73966954|NCT06311084|147470831|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966955|NCT06311084|147470832|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966956|NCT06311084|147470833|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966957|NCT06311084|147470834|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966958|NCT06311084|147470835|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966959|NCT06311084|147470836|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966960|NCT06311084|147470837|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966961|NCT06311084|147470838|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73919417|NCT06092710|147366750|SUPERIORITY|||||||0.0142266|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0142266
73919418|NCT06092710|147366750|SUPERIORITY|||||||0.0023308|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0023308
73919419|NCT06092710|147366750|SUPERIORITY|||||||0.0023308|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0023308
73919420|NCT06092710|147366750|SUPERIORITY|||||||0.9915779|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9915779
73919421|NCT06092710|147366750|SUPERIORITY|||||||0.9999943|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9999943
73919422|NCT06092710|147366750|SUPERIORITY|||||||0.9905111|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9905111
73919423|NCT03789318|147366756|SUPERIORITY|||||||0.2912|||||||ANOVA|||||||0.2912
73919424|NCT03789318|147366757|SUPERIORITY|||||||0.498|||||||ANOVA|||||||0.4980
73919425|NCT03789318|147366758|SUPERIORITY|||||||0.1958|||||||Log Rank|||||||0.1958
73919426|NCT03789318|147366759|SUPERIORITY|||||||0.9546|||||||Regression, Logistic|||||||0.9546
73919427|NCT03789318|147366760|SUPERIORITY|||||||0.4434|||||||ANOVA|||||||0.4434
73919428|NCT02480114|147366761|SUPERIORITY||Odds Ratio (OR)|0.549||||0.004|TWO_SIDED|95.0|0.364|0.827|||Proportional Odds Regression|||||0.827|0.364|0.004
73919429|NCT02480114|147366762|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1
73919430|NCT02480114|147366763|SUPERIORITY||Odds Ratio (OR)|0.371|||<|0.001|TWO_SIDED|95.0|0.244|0.597|||Proportional Odds Regression|||||0.597|0.244|<0.001
73919431|NCT03700671|147366783|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||A P-value of 0.05 was used as the threshold for significance|ANOVA|||A sample size of 38 using G\*Power 3.1 software was calculated based on previously published data in which the mean difference between HIIT and moderate intensity continuous training (MICT) was 3.2 ml.kg-1.min-1 with a pooled standard deviation of 3 ml.kg-1.min-1. Statistical significance was set at = 0.05 and power set to 0.95. To allow for 10% attrition 42 individuals were recruited to the study||||<0.01
73919432|NCT03700671|147366784|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||0.05 was used as a threshold for significance|ANOVA|||||||<0.01
73919433|NCT01317160|147366787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042|TWO_SIDED||||||Chi-squared|||Domeij-Arverud et al., Bone Joint J 2015;97-B:675-80.||||0.042
73919434|NCT01317160|147366787|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.81|||<|0.05|TWO_SIDED|95.0|1.25|6.32|||Regression, Logistic|Age was adjusted for in the calculation.|Risk of VTE by routine care (numerator) divided by IPC treatment (denominator)|||6.32|1.25|<0.05
73919435|NCT01317160|147366789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.737|TWO_SIDED||||||Chi-squared|||||||0.737
73919436|NCT04203238|147366807|SUPERIORITY||Median Difference (Final Values)|0.89|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
73919437|NCT02785354|147366861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.51|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95% Confidence Interval (CI ) (and death as a competing risk).||0.66|0.51|<0.0001
73919438|NCT02785354|147366861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0006|TWO_SIDED|95.0|0.75|0.92|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||0.92|0.75|0.0006
73966962|NCT06311084|147470839|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966963|NCT06311084|147470840|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73919439|NCT02785354|147366862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.46|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.66|0.46|<0.0001
73919440|NCT02785354|147366862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.58|0.79|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||0.79|0.58|<0.0001
73919441|NCT02785354|147366863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0007|TWO_SIDED|95.0|0.63|0.88|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.88|0.63|0.0007
73919442|NCT02785354|147366863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.8341|TWO_SIDED|95.0|0.85|1.14|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||1.14|0.85|0.8341
73919443|NCT02785354|147366864|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0147|TWO_SIDED|95.0|0.65|0.95|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.95|0.65|0.0147
73919444|NCT02785354|147366864|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0501|TWO_SIDED|95.0|0.71|1.0|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||1.00|0.71|0.0501
73919445|NCT02785354|147366865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.67|0.82|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.||0.82|0.67|<0.0001
73919446|NCT02785354|147366865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.71|0.84|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.||0.84|0.71|<0.0001
73919447|NCT02785354|147366866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.66|0.76|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.||0.76|0.66|<0.0001
73966964|NCT06311084|147470841|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966965|NCT06311084|147470842|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966966|NCT06311084|147470843|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966967|NCT06311084|147470844|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966968|NCT06311084|147470845|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73966969|NCT03988634|147470846|SUPERIORITY||Geometric Mean Ratio|0.8546||||0.0492|TWO_SIDED|95.0|0.7307|0.9994|||ANCOVA||Geometric Mean Ratio: sac/val vs valsartan|||0.9994|0.7307|0.0492
73966970|NCT03988634|147470847|SUPERIORITY||Win Ratio|1.193||||0.1578|TWO_SIDED|95.0|0.934|1.524|||unmatched pairwise win-ratio||A win ratio greater than 1 was in favor of sacubitril/valsartan arm|||1.524|0.934|0.1578
73966971|NCT03988634|147470848|SUPERIORITY||rate ratio|0.8346||||0.3563|TWO_SIDED|95.0|0.5684|1.2255|||LWYY model||A rate ratio \< 1 indicates an effect in favor of LCZ696|||1.2255|0.5684|0.3563
73966972|NCT03988634|147470849|SUPERIORITY||Rate ratio|0.6249||||0.3155|TWO_SIDED|95.0|0.2496|1.5649|||negative binomial regression model|||||1.5649|0.2496|0.3155
73966973|NCT03988634|147470850|SUPERIORITY||ratio of the change|0.9316||||0.4766|TWO_SIDED|95.0|0.7661|1.1329|||ANCOVA|||||1.1329|0.7661|0.4766
73966974|NCT03988634|147470851|SUPERIORITY||ratio of the change|0.8268|||<|0.0001|TWO_SIDED|95.0|0.76|0.91|||ANCOVA|||Week 4||0.91|0.76|<.0001
73966975|NCT03988634|147470851|SUPERIORITY||ratio of the change|0.8103|||<|0.0001|TWO_SIDED|95.0|0.74|0.89|||ANCOVA|||Week 8||0.89|0.74|<.0001
73966976|NCT04725240|147470854|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
73966977|NCT04725240|147470855|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
73966978|NCT04725240|147470856|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
73966979|NCT04725240|147470857|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
73966980|NCT05458011|147470872|OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.66|-0.95|||ANCOVA|||||-0.95|-2.66|<0.0001
73966981|NCT04850807|147470900|SUPERIORITY||average marginal effect|-0.4|STANDARD_ERROR_OF_MEAN|3.3|<|0.05|TWO_SIDED|95.0|-6.9|6.0|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI model), baseline CMAI (exclusive to ARBS model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|6.0|-6.9|<0.05
73966982|NCT04850807|147470901|SUPERIORITY||Average Marginal Effect|0.1|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED|95.0|-0.06|0.26|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI model), baseline CMAI (exclusive to ARBS model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|0.26|-0.06|<0.05
73966983|NCT04850807|147470902|SUPERIORITY||average marginal effect|4.0|STANDARD_ERROR_OF_MEAN|3.2|<|0.05|TWO_SIDED|95.0|-2.3|10.2|||Differences-in-Differences regression||||"Fixed effect covariates: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~Random effects: random intercept for nursing home Imputed Outcomes: 37 Control Follow-Up , 35 Treatment Follow-Up"|10.2|-2.3|<0.05
73966984|NCT04850807|147470903|SUPERIORITY||average marginal effect|-1.4|STANDARD_ERROR_OF_MEAN|3.6|<|0.05|TWO_SIDED|95.0|-8.5|5.6|||Differences-in-Differences regression||||"Results are adjusted for baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~The model includes a random intercept for nursing home."|5.6|-8.5|<0.05
73966985|NCT04850807|147470904|SUPERIORITY||average marginal effect|-4.8|STANDARD_ERROR_OF_MEAN|2.5|<|0.05|TWO_SIDED|95.0|-9.8|0.1|||Differences-in-Differences regression||||"Fixed effect covariates: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~Random effects: random intercept for nursing home Imputed Outcomes: 37 Control Follow-Up , 35 Treatment Follow-Up"|0.1|-9.8|<0.05
73966986|NCT04850807|147470906|SUPERIORITY||average marginal effect|-0.31|||<|0.05|TWO_SIDED|95.0|-1.03|0.41|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI/PHQ-9 model), baseline CMAI (exclusive to ARBS/PHQ-9 model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|0.41|-1.03|<0.05
74086602|NCT04100096|147726646|SUPERIORITY||Mean Difference (Final Values)|1.31||||0.062|TWO_SIDED|95.0|-0.07|2.68|||ANCOVA|ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.||Week 12||2.68|-0.07|0.0620
74086603|NCT04100096|147726647|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.4613|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.||Week 2||0.17|-0.08|0.4613
73919448|NCT02785354|147366866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.0001|TWO_SIDED|95.0|0.79|0.89|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.||0.89|0.79|<0.0001
73919449|NCT02064868|147366867|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0172|TWO_SIDED|95.0|0.51|0.98||One-sided p-value|Gehan's generalized Wilcoxon test|||||0.98|0.51|0.0172
73919450|NCT02064868|147366868|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0634|TWO_SIDED|95.0|0.61|1.02||Two-sided p-value|Gehan's generalized Wilcoxon test|||||1.02|0.61|0.0634
73919451|NCT02064868|147366869|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73919452|NCT02064868|147366870|SUPERIORITY|||||||0.0002|||||||Chi-squared|||||||0.0002
73919453|NCT02064868|147366871|SUPERIORITY|||||||0.1392|||||||Wilcoxon (Mann-Whitney)|||||||0.1392
73919454|NCT02064868|147366873|SUPERIORITY|||||||0.3115|||||||Mixed Models Analysis|||Day 5||||0.3115
73919455|NCT02064868|147366873|SUPERIORITY|||||||0.1236|||||||Mixed Models Analysis|||Day 14||||0.1236
74086604|NCT04100096|147726647|SUPERIORITY||Mean Difference (Final Values)|0.38||||0|TWO_SIDED|95.0|0.21|0.55||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 4||0.55|0.21|0
73919456|NCT00711711|147366874|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.||||0.51
73919457|NCT00711711|147366875|SUPERIORITY_OR_OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.||||0.58
73919458|NCT02664441|147366901|SUPERIORITY||Mean Difference (Net)|-1.7||||0.4|TWO_SIDED|95.0|-4.1|0.6|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||0.6|-4.1|0.40
73919459|NCT02664441|147366902|SUPERIORITY||Mean Difference (Net)|-3.1||||0.02|TWO_SIDED|95.0|-5.7|-0.4|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||-0.4|-5.7|0.02
73919460|NCT02664441|147366903|SUPERIORITY||Mean Difference (Final Values)|-20.2||||0.032|TWO_SIDED|95.0|-37.8|-2.7|||Regression, Linear|Adjusted for baseline values||Analysis for Fat Intake||-2.7|-37.8|.032
73919461|NCT02664441|147366903|SUPERIORITY||Mean Difference (Net)|-430.0||||0.02|TWO_SIDED|95.0|-761.0|-100.0|||Regression, Linear|Adjusted for baseline values||Analysis for Total Calorie Intake||-100|-761|.02
73919462|NCT02664441|147366904|SUPERIORITY||Geometric Mean Ratio|1.42||||0.19|TWO_SIDED|95.0|0.97|2.08|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||2.08|0.97|0.19
73919463|NCT02664441|147366905|SUPERIORITY||Geometric Mean Ratio|1.0||||0.82|TWO_SIDED|95.0|0.91|1.11|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|Analysis for HDL Cholesterol||1.11|0.91|0.82
73919464|NCT02664441|147366905|SUPERIORITY||Geometric Mean Ratio|1.0||||0.92|TWO_SIDED|95.0|0.83|1.19|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|Analysis for Triglycerides||1.19|0.83|0.92
73919465|NCT02664441|147366906|SUPERIORITY||Geometric Mean Ratio|0.62||||0.03|TWO_SIDED|95.0|0.41|0.92|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||0.92|0.41|0.03
73919466|NCT02664441|147366907|SUPERIORITY||Geometric Mean Ratio|1.39||||0.32|TWO_SIDED|95.0|0.9|2.14|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||2.14|0.90|0.32
73919467|NCT02664441|147366908|SUPERIORITY||Geometric Mean Ratio|0.95||||0.69|TWO_SIDED|95.0|0.81|1.1|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals.|||1.10|0.81|0.69
73966987|NCT02187003|147470907|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7944|TWO_SIDED|95.0|0.77|1.22|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95 percent (%) confidence interval (CI). A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P value.||1.22|0.77|0.7944
73919468|NCT02664441|147366909|SUPERIORITY||Mean Difference (Net)|-166.4||||0.004|TWO_SIDED|95.0|-269.7|-63.1|||Regression, Linear|Adjusted for baseline values||||-63.1|-269.7|0.004
73919469|NCT02664441|147366910|SUPERIORITY||Mean Difference (Net)|-145.0||||0.58|TWO_SIDED|95.0|-653.5|363.4|||Regression, Linear|Adjusted for baseline||||363.4|-653.5|0.58
73919470|NCT02664441|147366911|SUPERIORITY||Mean Difference (Net)|-8.5||||0.088|TWO_SIDED|95.0|-19.1|2.1|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||2.1|-19.1|0.088
74086605|NCT04100096|147726647|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0001|TWO_SIDED|95.0|0.21|0.61||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.61|0.21|0.0001
74088455|NCT00107042|147730260|SUPERIORITY_OR_OTHER||Responding Rate|88.0|||||TWO_SIDED|95.0|75.69|95.47|||||Response rate=Total number subjects responded/Total number subjects in arm|||95.47|75.69|
73919471|NCT01702454|147366919|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|8.97|||||TWO_SIDED|95.0|6.21|12.96|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for A/Christchurch strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||12.96|6.21|
73919472|NCT01702454|147366919|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|2.7|||||TWO_SIDED|95.0|1.81|4.02|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval|The adjusted GMT of HI antibodies for A/Victoria strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||4.02|1.81|
73919473|NCT01702454|147366919|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|3.94|||||TWO_SIDED|95.0|2.89|5.37|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Brisbane strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||5.37|2.89|
73919474|NCT01702454|147366919|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|6.71|||||TWO_SIDED|95.0|5.21|8.63|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Hub-Wuj strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||8.63|5.21|
74086606|NCT04100096|147726647|SUPERIORITY||Mean Difference (Final Values)|0.56||||0|TWO_SIDED|95.0|0.33|0.8||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 8||0.80|0.33|0
73919475|NCT01702454|147366921|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|44.74|||||TWO_SIDED|95.0|35.87|52.84||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||52.84|35.87|
73919476|NCT01702454|147366921|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|45.31|||||TWO_SIDED|95.0|36.58|53.3||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||53.3|36.58|
73919477|NCT01702454|147366921|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|37.86||||||95.0|28.83|46.26||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||46.26|28.83|
73919478|NCT01702454|147366921|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in percentages|56.0||||||95.0|48.32|63.04||||||"To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"||63.04|48.32|
73919479|NCT01702454|147366923|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|62.43|||||TWO_SIDED|95.0|55.27|68.89||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains||68.89|55.27|
73919480|NCT01702454|147366923|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|47.4|||||TWO_SIDED|95.0|39.08|55.06||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||55.06|39.08|
73966988|NCT02187003|147470908|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.7156|TWO_SIDED|95.0|0.77|1.19|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.||1.19|0.77|0.7156
73966989|NCT02187003|147470909|SUPERIORITY||Mean Difference (Net)|-0.06||||0.852|TWO_SIDED|95.0|-1.27|0.88|||ANCOVA|||The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P-value was from analysis of covariance (ANCOVA) model based on rank-transformed values using age group and genotype group as the stratification covariates.||0.88|-1.27|0.8520
74086607|NCT04100096|147726647|SUPERIORITY||Mean Difference (Final Values)|0.61||||0|TWO_SIDED|95.0|0.34|0.88||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 10||0.88|0.34|0
74088456|NCT00107042|147730261|SUPERIORITY_OR_OTHER||Responding rate|98.08|||||TWO_SIDED|95.0|89.74|99.95||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95% CI|||||99.95|89.74|
73919481|NCT01702454|147366923|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in SPR|56.68|||||TWO_SIDED|95.0|49.44|63.43||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||63.43|49.44|
73919482|NCT01702454|147366923|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|56.72|||||TWO_SIDED|95.0|49.41|63.49||||||"To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"||63.49|49.41|
73966990|NCT02187003|147470910|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8593|TWO_SIDED|95.0|0.82|1.26|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.||1.26|0.82|0.8593
73966991|NCT02187003|147470911|SUPERIORITY||Median Difference (Final Values)|-0.02||||0.9332|TWO_SIDED|95.0|-0.13|0.16|||ANCOVA|||The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P value was from ANCOVA model based on rank-transformed values using age group and genotype group as the stratification covariates.||0.16|-0.13|0.9332
73966992|NCT02187003|147470912|SUPERIORITY||Difference in percentage of participants|-1.17||||0.5349|TWO_SIDED|95.0|-5.19|2.46|||Chan and Zhang|||P values and 95% CI for the difference in percentages were based on the exact method by Chan and Zhang.||2.46|-5.19|0.5349
73966993|NCT02187003|147470919|SUPERIORITY||Risk Difference (RD)|-3.336||||0.302|TWO_SIDED|95.0|-10.024|2.968|||Chan and Zhang|||||2.968|-10.024|0.3020
73966994|NCT02187003|147470920|SUPERIORITY||Risk Difference (RD)|1.203||||0.5429|TWO_SIDED|95.0|-2.379|5.104|||Chan and Zhang|||||5.104|-2.379|0.5429
73966995|NCT04172441|147470932|SUPERIORITY||Difference in LS means|-5.21||||0.0037|TWO_SIDED|95.0|-8.29|-2.13|||Mixed Models Analysis|A mixed model was used, with treatment and period as fixed effects and patient as random effect.|The comparison was in the direction of dasiglucagon minus placebo.|Null hypothesis: weighted mean IV GIR in the last 12 hours of treatment with dasiglucagon = weighted mean IV GIR in the last 12 hours of treatment with placebo||-2.13|-8.29|0.0037
73966996|NCT04172441|147470933|SUPERIORITY||Difference in LS means|-30.93||||0.0238|TWO_SIDED|95.0|-56.8|-5.05|||Mixed Models Analysis|A mixed model was used, with treatment and period as fixed effects and patient as random effect.|The comparison was in the direction of dasiglucagon minus placebo.|Null hypothesis: Total amount of carbohydrates administered (regardless of route) per day in patients treated with dasiglucagon = total amount of carbohydrates administered (regardless of route) per day in patients treated with placebo||-5.05|-56.80|0.0238
73966997|NCT00676715|147470954|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||<0.0001
73966998|NCT00676715|147470954|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||<0.0001
74086608|NCT04100096|147726647|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.0004|TWO_SIDED|95.0|0.23|0.8||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.80|0.23|0.0004
73966999|NCT00676715|147470954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7496|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||0.7496
73967000|NCT00676715|147470955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.0019
73967001|NCT00676715|147470955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0136|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.0136
73967002|NCT00676715|147470955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1814|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.1814
73967003|NCT00676715|147470956|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.6||||0.1978|TWO_SIDED|95.0|0.27|1.34|||Cochran-Mantel-Haenszel chi-square test|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by geographical region only.||||1.34|0.27|0.1978
73967004|NCT00676715|147470956|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.53||||0.131|TWO_SIDED|95.0|0.23|1.22|||CMH chi-square test|CMH chi-square test stratified by geographical region only.||||1.22|0.23|0.1310
73967005|NCT00676715|147470956|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.92||||0.8206|TWO_SIDED|95.0|0.46|1.84|||CMH chi-square tes|CMH chi-square test stratified by geographical region only.||||1.84|0.46|0.8206
74086609|NCT04100096|147726649|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1687|TWO_SIDED|95.0|-0.04|0.25||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.25|-0.04|0.1687
73919483|NCT00710710|147366956|OTHER||Maximum likelihood estimation|0.0233||||0.7021|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.7021
73967006|NCT00676715|147470957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1391|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.1391
73967007|NCT00676715|147470957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1596|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.1596
73967008|NCT00676715|147470957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.4740
73967009|NCT00676715|147470958|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
74086610|NCT04100096|147726649|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.1874|TWO_SIDED|95.0|-0.06|0.29||Analysis of covariance (ANCOVA) model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.29|-0.06|0.1874
73919484|NCT00710710|147366956|OTHER||Maximum likelihood estimation|0.0233||||0.9156|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.9156
73919485|NCT00710710|147366956|OTHER||Maximum likelihood estimation|0.0233||||0.7021|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.7021
73919486|NCT00710710|147366956|OTHER||Maximum likelihood estimation|0.0233||||0.9156|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.9156
73919487|NCT00710710|147366959|OTHER||Hazard Ratio (HR)|1.22||||0.38|TWO_SIDED|95.0|0.78|1.91|||Regression, Cox||if HR is below 1, then 60mg BI 2536 IV on day 1-3 is better.|||1.91|0.78|0.38
73919488|NCT00710710|147366960|OTHER||Hazard Ratio (HR)|1.1||||0.69|TWO_SIDED|95.0|0.68|1.78|||Regression, Cox||if HR is below 1, then 60mg BI 2536 IV on day 1-3 is better.|||1.78|0.68|0.69
73919489|NCT00710710|147366961|OTHER||Maximum likelihood estimation|0.0||||0.9161|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9161
73919490|NCT00710710|147366961|OTHER||Maximum likelihood estimation|0.0||||0.9842|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9842
73919491|NCT00710710|147366961|OTHER||Maximum likelihood estimation|0.0||||0.9161|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9161
73919492|NCT00710710|147366961|OTHER||Maximum likelihood estimation|0.0||||0.9842|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9842
73919493|NCT03510884|147366968|SUPERIORITY|Bonferroni adjustment was applied to handle multiplicity for the comparison of each alirocumab dosing regimen group versus its placebo group for the primary efficacy endpoint.|LS mean difference|-43.3|STANDARD_ERROR_OF_MEAN|5.5|<|0.0001|TWO_SIDED|97.5|-56.0|-30.7||The threshold for statistical significance was 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per interactive voice response system (IVRS), time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-30.7|-56.0|<0.0001
73919494|NCT03510884|147366968|SUPERIORITY|Bonferroni adjustment was applied to handle multiplicity for the comparison of each alirocumab dosing regimen group versus its placebo group for the primary efficacy endpoint.|LS mean difference|-33.8|STANDARD_ERROR_OF_MEAN|5.5|<|0.0001|TWO_SIDED|97.5|-46.4|-21.2||The threshold for statistical significance was 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-21.2|-46.4|<0.0001
73919495|NCT03510884|147366969|SUPERIORITY|Hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported and independently for each dosing regimen. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Statistical significance of the primary endpoint was required before testing the first secondary endpoint for each dosing regimen independently.|LS mean difference|-45.5|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001|TWO_SIDED|97.5|-56.3|-34.7||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-34.7|-56.3|<0.0001
73919496|NCT03510884|147366969|SUPERIORITY|A hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported and independently for each dosing regimen. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Statistical significance of the primary endpoint was required before testing the first secondary endpoint for each dosing regimen independently.|LS mean difference|-41.5|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|97.5|-52.7|-30.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-30.2|-52.7|<0.0001
73967010|NCT00676715|147470958|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
73967011|NCT00676715|147470958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4985|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.4985
73967012|NCT00676715|147470959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.0004
74086611|NCT04100096|147726650|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.0974|TWO_SIDED|95.0|-0.25|0.02||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 6||0.02|-0.25|0.0974
73919497|NCT03510884|147366970|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-37.8|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED|97.5|-47.5|-28.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-28.2|-47.5|<0.0001
73919498|NCT03510884|147366970|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-30.7|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|97.5|-42.0|-19.4||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-19.4|-42.0|<0.0001
73919499|NCT03510884|147366971|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-40.7|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001|TWO_SIDED|97.5|-52.2|-29.1||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-29.1|-52.2|<0.0001
73919500|NCT03510884|147366971|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-31.9|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001|TWO_SIDED|97.5|-44.1|-19.7||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-19.7|-44.1|<0.0001
73919501|NCT03510884|147366972|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-30.8|STANDARD_ERROR_OF_MEAN|3.9|<|0.0001|TWO_SIDED|97.5|-39.8|-21.9||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-21.9|-39.8|<0.0001
73919502|NCT03510884|147366972|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-23.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|97.5|-33.5|-13.1||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-13.1|-33.5|<0.0001
73919503|NCT03510884|147366973|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-38.9|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|97.5|-48.2|-29.6||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-29.6|-48.2|<0.0001
73919504|NCT03510884|147366973|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-32.8|STANDARD_ERROR_OF_MEAN|4.3|<|0.0001|TWO_SIDED|97.5|-42.8|-22.7|||MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-22.7|-42.8|<0.0001
73967013|NCT00676715|147470959|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
74086612|NCT04100096|147726650|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.391|TWO_SIDED|95.0|-0.2|0.08||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 12||0.08|-0.20|0.3910
73919505|NCT03510884|147366974|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-42.8|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001|TWO_SIDED|97.5|-53.8|-31.8||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Non-HDL-C value and Baseline Non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-31.8|-53.8|<0.0001
73919506|NCT03510884|147366974|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|97.5|-47.9|-27.0||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-27.0|-47.9|<0.0001
73919507|NCT03510884|147366975|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|97.5|-41.3|-24.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-24.2|-41.3|<0.0001
73919508|NCT03510884|147366975|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-27.9|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|97.5|-35.6|-20.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-20.2|-35.6|<0.0001
73919509|NCT03510884|147366976|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|77.6|||=|0.0001|TWO_SIDED|97.5|6.3|960.0||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. Logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||960.0|6.3|=0.0001
73931011|NCT01462357|147391796|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.15|1.14||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||1.14|-1.15|
73967014|NCT00676715|147470959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2725|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.2725
73967015|NCT01820260|147470961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED|||||To account for multiple testing, the 4 pairwise tests with corresponding vehicle group were performed using Bonferroni method testing at a 1.25% significance level, securing that the overall significance level did not exceed 5%|Fisher Exact|||Complete clearance of AKs at Week 8 was to be analysed by log binomial regression with factors treatment group, anatomical location (face/chest or scalp) and analysis site. Due to the low numbers of subjects obtaining complete clearance in the vehicle groups,the proposed model did not converge and Fisher's exact test was used instead to compare active treatments with the respective vehicle arm.||||0.0002
73967016|NCT01820260|147470961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|TWO_SIDED|||||see comments in analysis 1|Fisher Exact|||See comment in analysis 1||||0.0037
73967017|NCT01820260|147470961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0171|TWO_SIDED|||||See comments in analysis 1|Fisher Exact|||See comments in analysis 1||||0.0171
73967018|NCT01820260|147470961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Fisher Exact|||||||0.0001
74086613|NCT04100096|147726651|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0063|TWO_SIDED|9.0|0.04|0.26||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.26|0.04|0.0063
74086614|NCT04100096|147726651|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.067|TWO_SIDED|95.0|-0.01|0.19||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.19|-0.01|0.0670
74088457|NCT00107042|147730262|SUPERIORITY_OR_OTHER||Responding Rate|91.49||||||95.0|79.62|97.63||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95 % confidence interval|||||97.63|79.62|
73919510|NCT03510884|147366976|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|14.9|||<|0.0001|TWO_SIDED|97.5|3.2|69.8||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. Logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||69.8|3.2|<0.0001
73967019|NCT01820260|147470962|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||To account for multiple testing among the secondary endpoints, a hierarchical order of testing was determined, where the following evaluation was done separately for each of the four active groups: Provided the primary endpoint was significant at a 1.25% level, the comparison to vehicle in terms of reduction in AK count from baseline to week 8 was tested at a 1.25% level. Provided this test was significant, the second secondary endpoint,partial clearance, was tested(vs. vehicle) at a 1.25% level||||< 0.001
73967020|NCT01820260|147470962|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||See comment in analysis 1||||< 0.001
73861450|NCT04411420|147268785|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.37|TWO_SIDED|97.5|-1.31|0.5||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.50|-1.31|0.37
73861451|NCT04411420|147268785|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.24|TWO_SIDED|97.5|-1.54|0.39||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.39|-1.54|0.24
73861452|NCT04411420|147268785|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.37|TWO_SIDED|97.5|-1.43|0.54|||Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.54|-1.43|0.37
73861453|NCT04411420|147268786|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.727|TWO_SIDED|97.5|-0.51|0.72||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.72|-0.51|0.727
73861454|NCT04411420|147268786|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.478|TWO_SIDED|97.5|-0.43|0.91||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.91|-0.43|0.478
73861455|NCT04411420|147268786|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.894|TWO_SIDED|97.5|-0.75|0.66||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.66|-0.75|0.894
73861456|NCT04411420|147268787|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.222|TWO_SIDED|95.0|-0.15|0.04||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.04|-0.15|0.222
73861457|NCT04411420|147268787|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-0.1|0.09||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.09|-0.10|0.988
73861458|NCT04411420|147268787|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.269|TWO_SIDED|95.0|-0.16|0.05||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.05|-0.16|0.269
73919511|NCT03510884|147366977|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|26.5|||<|0.0001|TWO_SIDED|97.5|4.0|174.8||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||174.8|4.0|<0.0001
73967021|NCT01820260|147470962|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||See comment analysis 1||||< 0.001
73967022|NCT01820260|147470962|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||z-test|||See comment in analysis 1||||< 0.001
73967023|NCT01820260|147470963|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||Analysis of partial clearance of AK's at Week 8 was done in the same way as for the primary outcome (endpoint)||||<0.001
73967024|NCT01820260|147470963|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
74086615|NCT02744755|147726681|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.129|||TWO_SIDED|95.0|-0.24|0.27||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 95% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.27|-0.24|
74086616|NCT02744755|147726681|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.129|||TWO_SIDED|90.0|-0.19|0.23||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 90% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.23|-0.19|
73919512|NCT03510884|147366977|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|40.9|||<|0.0001|TWO_SIDED|97.5|5.7|290.9||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||290.9|5.7|<0.0001
73861459|NCT04411420|147268788|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.477|TWO_SIDED|95.0|-0.22|0.1||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.10|-0.22|0.477
73919513|NCT03510884|147366978|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|52.7|||=|0.0011|TWO_SIDED|97.5|3.5|804.3||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||804.3|3.5|=0.0011
73919514|NCT03510884|147366978|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|43.1|||=|0.0006|TWO_SIDED|97.5|3.7|498.6||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||498.6|3.7|=0.0006
73931012|NCT01462357|147391797|NON_INFERIORITY|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% CI for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.61|||||TWO_SIDED|95.0|0.54|0.69|||ANOVA|||Immune response to anti-HPV-16 in terms of Geometric Mean Titers (GMT): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||0.69|0.54|
73967025|NCT01820260|147470963|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
73967026|NCT01820260|147470963|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
73967027|NCT01351805|147471006|OTHER|Test of change from baseline as above.|Percent change in geometric means|8.19||||0.02|TWO_SIDED|95.0|1.52|15.31||IL-6 from baseline to one year: overall % change= 8.19% (95%CI 1.52-15.31).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||15.31|1.52|0.02
73967028|NCT01351805|147471006|OTHER|Test of change from baseline as above.|Percent change in geometric means|-0.73||||0.97|TWO_SIDED|95.0|-6.87|5.81||4\. IL-6 from baseline to one year: overall % change= -0.73% (95%CI -6.87 to 5.81).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||5.81|-6.87|0.97
73967029|NCT01351805|147471006|SUPERIORITY|Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1,p for interaction between strata.||||||0.12||||||Test of multiplicative interaction between the effects of the two supplements|p for interaction|||Test for interaction between effect of vitamin D and effect of omega-3 fatty acids on IL-6 change from baseline to 1 year||||0.12
73919515|NCT03510884|147366979|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|41.3|||<|0.0001|TWO_SIDED|97.5|6.6||The percentage of participants reaching LDL-C level lower than 110 mg/dL was 0% in the placebo arm, as a result it was possible to derive the estimated odds-ratio, but the estimated confidence interval (CI) was very wide, with the upper limit estimated to Infinity, therefore upper limit of 97.5% CI was not available to report.|Threshold for significance at 0.025 level.|Exact conditional logistic regression||Alirocumab Q2W versus Placebo Q2W: Odds ratios and confidence intervals estimated from exact conditional logistic regression model.|The LOCF approach followed by exact conditional logistic regression model. The exact conditional logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the quartiles of the Baseline LDL-C value.|||6.6|<0.0001
73967030|NCT01351805|147471007|OTHER|Test of change from baseline as above.|Percent change in geometric means|7.12||||0.16|TWO_SIDED|95.0|-1.81|16.87||3\. HsCRP from baseline to one year: overall % change= 7.12% (95%CI -1.81-16.78).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||16.87|-1.81|0.16
73967031|NCT01351805|147471007|OTHER|Test of change from baseline as above.|Percent change in geometric means|-3.89||||0.44|TWO_SIDED|95.0|-11.92|4.86||6\. HsCRP from baseline to one year: overall % change= -3.89% (95%CI -11.92-4.86).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||4.86|-11.92|0.44
73967032|NCT01351805|147471007|SUPERIORITY|||||||0.38|||||||P for interaction|||Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.||||0.38
73967033|NCT01351805|147471008|OTHER|Test of change from baseline as above.|Percent change in geometric means|0.63||||0.57|TWO_SIDED|95.0|-1.03|2.31||2\. TNFR2 from baseline to one year: overall % change= 0.63% (95%CI -1.03 to 2.31).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||2.31|-1.03|0.57
73967034|NCT01351805|147471008|OTHER|Test of change from baseline as above.|Percent change in geometric means|-1.27||||0.13|TWO_SIDED|95.0|-2.89|0.39||5\. TNFR2 from baseline to one year: overall % change= -1.27% (95%CI -2.89 to 0.39).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||0.39|-2.89|0.13
73967035|NCT01351805|147471008|SUPERIORITY|Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1 with p for interaction between strata.||||||0.74|||||||P for interaction|||Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.||||0.74
73967036|NCT01351805|147471009|OTHER||Cox Proportional Hazard|0.78||||0.05|TWO_SIDED|95.0|0.61|0.99|||Regression, Cox|||||0.99|0.61|0.05
73967037|NCT01351805|147471009|SUPERIORITY||Cox Proportional Hazard|0.85||||0.19|TWO_SIDED|95.0|0.67|1.08|||Regression, Cox|||||1.08|0.67|0.19
73967038|NCT01351805|147471009|SUPERIORITY|||||||0.2|||||||P for interaction|p multiplicative interaction between effects of vitamin D and n-3 fa supplements||Test for multiplicative interaction between the effects of randomized treatment groups, vitamin D and n-3 fa on incidence of autoimmune disease.||||0.20
73967039|NCT01351805|147471010|OTHER|We assessed the main effects of the treatment arms comparing all those randomized to omega-3 fatty acids or omega-3 fatty acid placebo, regardless of vitamin D randomization status.||||||0.77||||||Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.|Mixed Models Analysis|Repeated measures model with censoring for total knee replacement.||Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.||||0.77
74027905|NCT00035815|147609344|SUPERIORITY_OR_OTHER|||||||0.529||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis of MMT was calculated as a ratio of change from baseline to last follow-up to time to duration until last follow-up. For the patients that died during the study period, the last follow-up time was considered as the time of death with a zero score for MMT measurement. Analysis was performed using intention to treat approach. Comparison of rate of change in MMT scores between the placebo and IGF-1 group was made using two sample t-test or Wilcoxon rank sum test as appropriate.||||0.529
74027906|NCT00035815|147609345|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.415|TWO_SIDED|95.0|0.77|1.4|||Regression, Cox|||Patients who elected to proceed to tracheostomy were assessed on the day of their procedure. Subjects who continuously utilized NIPPV for greater than 10 days were assessed as being ventilator-dependent on the first day they began continuous NIPPV. Survival between groups was compared using the Cox-proportional Hazards model.||1.4|0.77|0.415
74086617|NCT02744755|147726682|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.096|||TWO_SIDED|95.0|-0.11|0.27|||ANCOVA|||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.||0.27|-0.11|
73919516|NCT03510884|147366979|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|104.8|||=|0.0005|TWO_SIDED|97.5|5.2|2095.9||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||2095.9|5.2|=0.0005
73919517|NCT03510884|147366980|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-15.2|STANDARD_ERROR_OF_MEAN|6.7|=|0.0237|TWO_SIDED|97.5|-30.3|-0.1||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q2W versus Placebo Q2W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||-0.1|-30.3|=0.0237
73919518|NCT03510884|147366980|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-24.9|STANDARD_ERROR_OF_MEAN|8.7|=|0.0043|TWO_SIDED|97.5|-44.4|-5.4||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q4W versus Placebo Q4W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||-5.4|-44.4|=0.0043
73919519|NCT03510884|147366981|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-5.6|STANDARD_ERROR_OF_MEAN|7.1|=|0.4288|TWO_SIDED|97.5|-21.7|10.4||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q2W versus Placebo Q2W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||10.4|-21.7|=0.4288
73919520|NCT03510884|147366981|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-13.5|STANDARD_ERROR_OF_MEAN|8.6|=|0.1148|TWO_SIDED|97.5|-32.7|5.7||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q4W versus Placebo Q4W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||5.7|-32.7|=0.1148
73919521|NCT02560584|147367011|SUPERIORITY||||||<|0.0001|||||||Exact one-sided test for a single propor|||"The proportion of patients with malignancy detected only with BLC with Cysview was to be analyzed using an exact one-sided test for a single proportion based on the cumulative binomial distribution with a significance level of 2.5%.~Null hypothesis: Malignancy is detected with BL only in 0.5% or less of the patients"||||<0.0001
73919522|NCT02560584|147367013|SUPERIORITY||||||<|0.0001|||||||Exact one-sided test for single proporti|||"The proportion of patients with one or more CIS lesions detected with BL and none with WL was to be evaluated using an exact binomial test for single proportion with a significance level of 2.5% (one-sided).~Null hypothesis: One or more CIS lesions are detected with BLC with Cysview and none with WL in less than or equal to 0.1% of the patients."||||<0.0001
73919523|NCT01529346|147367016|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.38|0.22||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.22|-0.38|
73967040|NCT01351805|147471010|OTHER|We assessed the main effects of the treatment arms comparing all those randomized to vitamin D or vitamin D placebo, regardless of omega-3 fatty acid randomization status.||||||0.41||||||Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.|Mixed Models Analysis|Linear time by treatment interaction (comparing change in WOMAC pain over time in two randomized groups)||Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.|We assessed for effect modification between vitamin D and N-3 FA and tested for other pre-specified interactions. We again used a repeated measures model with censoring for TKR. We adjusted for age, sex and N-3 FA treatment arm (in analyses in which N-3 FA treatment arm was not investigated as a potential modifier).|||0.41
73967041|NCT01351805|147471010|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|1.9||0.42|TWO_SIDED||||||Regression, Linear|||Active n3fa vs placebo n3fa among those on placebo vitamin D.||||0.42
73967042|NCT01351805|147471010|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.|Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|1.8||0.18|TWO_SIDED||||||Regression, Linear|||Vitamin D vs. vitamin D placebo among those on placebo omega-3 fatty acids- stratified analyses.||||0.18
74086618|NCT02744755|147726682|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.096|||TWO_SIDED|90.0|-0.08|0.24|||ANCOVA|||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.||0.24|-0.08|
73919524|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.2|0.39||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.39|-0.20|
73919525|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.28|0.32||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.32|-0.28|
73919526|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.41|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.24|-0.41|
73919527|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.32|0.44||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.44|-0.32|
73919528|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.01|0.77||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|0.01|
73919529|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.22|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.54|-0.22|
73919530|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.24|1.07||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.07|0.24|
73919531|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.37|0.42||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.42|-0.37|
73967043|NCT01351805|147471010|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|1.89||0.84|TWO_SIDED||||||Regression, Linear|||Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on active vitamin D.||||0.84
74086619|NCT00880087|147726704|SUPERIORITY||Risk Difference (RD)|-2.6||||0.63|TWO_SIDED|95.0|-14.5|9.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||9.2|-14.5|0.63
74086620|NCT00880087|147726705|SUPERIORITY||Risk Difference (RD)|2.8||||0.56|TWO_SIDED|95.0|-8.0|13.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||13.7|-8.0|0.56
73919532|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.0|0.78||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.78|-0.00|
73919533|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.29|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.50|-0.29|
73919534|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|0.59|1.45||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.45|0.59|
73919535|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.21|0.62||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.21|
73919536|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.07|0.76||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.76|-0.07|
73919537|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.11|0.72||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.72|-0.11|
73919538|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|0.85|1.75||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.75|0.85|
73919539|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.04|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.81|-0.04|
73919540|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.1|0.75||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.75|-0.10|
73919541|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.05|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.81|-0.05|
73919542|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|1.69|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|1.22|2.15||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.15|1.22|
73919543|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.01|0.99||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.99|0.01|
73919544|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.05|1.03||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.03|0.05|
73919545|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.04|0.94||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.94|-0.04|
73919546|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|1.79|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|1.26|2.31||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.31|1.26|
73967044|NCT01351805|147471010|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.|Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|1.8||0.76|TWO_SIDED||||||Regression, Linear|||Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on placebo vitamin D.||||0.76
73967045|NCT05229120|147471039|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.124|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||A single-sided paired-samples t-test comparing k-values at baseline to k-values at follow-up (approximately 4 weeks after baseline assessment) was examined. Given that k-values are typically skewed (and to be consistent with the existing literature) we used a log-k as our outcome variable.||||.124
73967046|NCT05229120|147471040|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.219|TWO_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 14.||Changes in consideration of future consequences (parenting) was evaluated using one-sided paired samples t-tests.||||.219
73967047|NCT05229120|147471041|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.5|TWO_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 5||Performed a one-sided paired samples t-test examining changes in both positive parenting.||||.50
73919547|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.06|1.11||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.11|0.06|
73919548|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.11|1.17||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.17|0.11|
73967048|NCT05229120|147471041|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.187|TWO_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in negative parenting.||||.187
73967049|NCT05229120|147471042|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.498|TWO_SIDED||||||t-test, 1 sided|||Examined changes in parental involvement using a paired-samples t-test.||||.498
73967050|NCT05229120|147471042|SUPERIORITY||Mean Difference (Final Values)|1.301||||0.108|TWO_SIDED||||||t-test, 1 sided|||Examined changes in positive parenting using paired samples t-tests||||.108
73967051|NCT05229120|147471042|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.145|TWO_SIDED||||||t-test, 1 sided|||Examined changes in parental monitoring using a paired samples t-test||||.145
73967052|NCT05229120|147471042|SUPERIORITY||Mean Difference (Final Values)|-0.688||||0.252|TWO_SIDED||||||t-test, 1 sided|||Examined changes in inconsistent parenting using a paired samples one-sided t-test||||.252
73919549|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.11|1.15||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.15|0.11|
73919550|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|1.33|2.4||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.40|1.33|
73919551|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.07|1.05||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.05|-0.07|
73919552|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.24|0.91||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.91|-0.24|
73919553|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.13|0.98||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.98|-0.13|
73919554|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|1.05|2.17||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.17|1.05|
73919555|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-0.74|0.64||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.64|-0.74|
73919556|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.86|0.56||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.56|-0.86|
73919557|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-0.57|0.8||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.80|-0.57|
73919558|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|0.22|1.58||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.58|0.22|
73919559|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|90.0|-0.93|0.59||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.59|-0.93|
73919560|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.98|0.62||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.98|
73919561|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.05|0.45||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-1.05|
73919562|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-0.47|1.02||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.02|-0.47|
73967053|NCT05229120|147471042|SUPERIORITY||Mean Difference (Final Values)|0.306||||0.382|TWO_SIDED||||||t-test, 1 sided|||Examined changes in corporal punishment using a paired samples one-tailed t-test||||.382
73967054|NCT05862870|147471051|OTHER|Frequency count|exact count|20.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|0.0|20.0|20.0|||count|||Frequency count of patients retained in treatment.|Threshold for frequency count|20|20|.05
73967055|NCT02991534|147471116|SUPERIORITY||Odds Ratio (OR)|1.09||||0.003|TWO_SIDED|95.0|1.03|1.152|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.152|1.030|.003
73967056|NCT02991534|147471117|SUPERIORITY||Odds Ratio (OR)|1.0||||0.91|TWO_SIDED|95.0|0.976|1.022|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.022|0.976|0.91
73967057|NCT02991534|147471118|SUPERIORITY||Odds Ratio (OR)|1.06||||0.265|TWO_SIDED|95.0|0.959|1.165|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.165|.959|.265
73919563|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|0.15|1.11||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.11|0.15|
73919564|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.27|0.74||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.74|-0.27|
73919565|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.03|0.91||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.91|-0.03|
73919566|NCT01529346|147367016|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.3|0.67||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.67|-0.30|
73919567|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.19|0.14||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.14|-0.19|
73919568|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|0.03|0.37||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.37|0.03|
73919569|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.1|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.24|-0.10|
73919570|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.16|0.21||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.21|-0.16|
73919571|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.06|0.45||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-0.06|
73919572|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.19|0.7||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.70|0.19|
73919573|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.04|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.54|0.04|
73919574|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.32|0.87||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.87|0.32|
73919575|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.16|0.4||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.40|-0.16|
73919576|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.12|0.68||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.68|0.12|
73919577|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.05|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.50|-0.05|
73967058|NCT02991534|147471119|SUPERIORITY||Odds Ratio (OR)|1.01||||0.015|TWO_SIDED|95.0|1.002|1.022|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.022|1.002|0.015
74086621|NCT00880087|147726706|SUPERIORITY|||||||0.7|||||||Stratified Mann-Whitney Test|Test stratified by age category (\<2 years, 2 to \<12 years, or \>=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.|||0.70
73967059|NCT02323321|147471133|OTHER|The primary hypothesis for this study is that the true (success) proportion of transplanted patients meeting the primary effectiveness endpoint, patient survival at day 30 post-transplantation and absence of severe PGD (left or right ventricle) in the first 24 hours post-transplantation, is greater than the Performance Goal value of 0.65.|Proportion|88.0|||<|0.0001|TWO_SIDED|95.0|78.4|94.4|||one-sided exact binomial test|||||94.4|78.4|<0.0001
73919578|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.4|1.01||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.01|0.40|
73919579|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.19|0.4||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.40|-0.19|
73919580|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.1|0.49||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.49|-0.10|
73919581|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.16|0.43||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.43|-0.16|
73919582|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|0.41|1.06||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.06|0.41|
73919583|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.01|0.64||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.64|0.01|
73919584|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.01|0.62||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.01|
73919585|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.08|0.71||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.71|0.08|
73919586|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|0.92|1.61||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.61|0.92|
73919587|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|0.04|0.76||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.76|0.04|
73919588|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.03|0.69||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.69|-0.03|
73919589|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|0.05|0.77||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|0.05|
73919590|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.92|1.68||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.68|0.92|
73919591|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.16|0.95||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.95|0.16|
73919592|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.17|0.97||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.97|0.17|
73919593|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.24|1.03||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.03|0.24|
73919594|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.97|1.78||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.78|0.97|
73919595|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.08|0.92||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.92|0.08|
73919596|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.03|0.84||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.84|-0.03|
73919597|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.09|0.93||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.93|0.09|
73919598|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.75|1.59||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.59|0.75|
73919599|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.27|0.72||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.72|-0.27|
73919600|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.37|0.65||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.65|-0.37|
73919601|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.23|0.77||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|-0.23|
73919602|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.33|1.31||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.31|0.33|
73919603|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.24|0.89||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.89|-0.24|
73919604|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-0.25|0.94||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.94|-0.25|
73919605|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.31|0.8||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.80|-0.31|
73967060|NCT00446225|147471134|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0001|TWO_SIDED|95.0|0.27|0.64|||Log Rank|||||0.64|0.27|0.0001
73967061|NCT00446225|147471136|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.043|TWO_SIDED|95.0|0.36|0.99|||Log Rank|||||0.99|0.36|0.043
73967062|NCT03526874|147471174|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
73967063|NCT03526874|147471175|SUPERIORITY|||||||0.031|||||||t-test, 2 sided|||||||0.031
73967064|NCT03526874|147471176|SUPERIORITY|||||||0.0162|||||||ANOVA|Two-way Anova to test sex interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0162
73967065|NCT03526874|147471177|SUPERIORITY|||||||0.04||||||Two-way Anova to test sex interaction with treatment effect. The study was not powered for subgroup analyses.|ANOVA|||||||0.04
73967066|NCT03526874|147471178|SUPERIORITY|||||||0.0098|||||||ANOVA|Two-way Anova to test ethnicity interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0098
73919606|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|0.08|1.19||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.19|0.08|
73919607|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.07|0.83||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.83|0.07|
73919608|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.36|0.44||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.44|-0.36|
73919609|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.07|0.68||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.68|-0.07|
73919610|NCT01529346|147367017|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.32|0.45||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-0.32|
73967067|NCT03526874|147471179|SUPERIORITY|||||||0.02|||||||ANOVA|Two-way Anova to test ethnicity interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.02
74027907|NCT00035815|147609346|SUPERIORITY_OR_OTHER|||||||0.321||95.0|||||Wilcoxon (Mann-Whitney)|||The final secondary outcome measure was the rate of change in the ALSFRS-r score. The ALSFRS-r was completed at each visit (randomization and then at 3, 6, 12, 18 and 24 months post-randomization). As with the MMT scores a score of 0 was imputed on the day of death. Analysis of the ALSFRS-r scores as a secondary outcome was performed in similar manner as MMT score.||||0.321
74027908|NCT03551522|147609347|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|11.02||||0.0874|TWO_SIDED|95.0|-1.63|23.67|||ANCOVA|||||23.67|-1.63|0.0874
74086622|NCT00880087|147726707|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."||||||0.46
74086623|NCT01011556|147726709|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.17|||<|0.001|TWO_SIDED|90.0|-8.489|-5.851|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-5.851|-8.489|<0.001
73919611|NCT01529346|147367018|SUPERIORITY_OR_OTHER||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.43|3.71||||||SPID(6): LS mean estimate of the treatment difference along with 90% confidence interval (CI) were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.71|0.43|
73919612|NCT01529346|147367018|SUPERIORITY_OR_OTHER||LS Mean Difference|1.69|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.05|3.33||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.33|0.05|
73967068|NCT03526874|147471180|SUPERIORITY|||||||0.01|||||||ANOVA|Two-way Anova to test race interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.01
73967069|NCT03526874|147471181|SUPERIORITY|||||||0.0329|||||||ANOVA|Two-way Anova to test race interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0329
73967070|NCT03526874|147471182|SUPERIORITY|||||||0.294|||||||t-test, 2 sided|||||||0.294
74027909|NCT03551522|147609347|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|6.54||||0.3151|TWO_SIDED|95.0|-6.28|19.37|||ANCOVA|||||19.37|-6.28|0.3151
74086624|NCT01011556|147726709|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.48|||<|0.001|TWO_SIDED|90.0|-8.822|-6.144|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-6.144|-8.822|<0.001
74086625|NCT01011556|147726709|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-6.17|||<|0.001|TWO_SIDED|90.0|-7.448|-4.891|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-4.891|-7.448|<0.001
74086626|NCT01011556|147726710|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-4.58|||<|0.001|TWO_SIDED|90.0|-5.716|-3.452|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-3.452|-5.716|<0.001
73919613|NCT01529346|147367018|SUPERIORITY_OR_OTHER||LS Mean Difference|2.34|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|90.0|0.69|3.99||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.99|0.69|
73967071|NCT03526874|147471183|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
73967072|NCT03526874|147471184|SUPERIORITY|||||||0.182|||||||t-test, 2 sided|||||||0.182
73967073|NCT03526874|147471185|SUPERIORITY|||||||0.423|||||||Fisher Exact|||||||0.423
73967074|NCT03526874|147471186|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.030
73967075|NCT03526874|147471187|SUPERIORITY|||||||0.112|||||||Fisher Exact|||||||0.112
73967076|NCT03526874|147471188|SUPERIORITY|||||||0.052|||||||Fisher Exact|||||||0.052
73967077|NCT03526874|147471189|SUPERIORITY|||||||0.027|||||||Chi-squared|||||||0.027
73919614|NCT01529346|147367018|SUPERIORITY_OR_OTHER||LS Mean Difference|6.99|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|5.19|8.79||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||8.79|5.19|
73919615|NCT01529346|147367018|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|90.0|1.97|17.63||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||17.63|1.97|
73919616|NCT01529346|147367018|SUPERIORITY_OR_OTHER||LS Mean Difference|3.55|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|90.0|-4.28|11.37||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||11.37|-4.28|
73919617|NCT01529346|147367018|SUPERIORITY_OR_OTHER||LS Mean Difference|10.82|STANDARD_ERROR_OF_MEAN|4.76|||TWO_SIDED|90.0|2.97|18.68||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||18.68|2.97|
73919618|NCT01529346|147367018|SUPERIORITY_OR_OTHER||LS Mean Difference|22.39|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|90.0|13.82|30.97||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||30.97|13.82|
73919619|NCT01529346|147367019|SUPERIORITY_OR_OTHER||LS Mean Difference|12.26|STANDARD_ERROR_OF_MEAN|6.66|||TWO_SIDED|90.0|1.26|23.27||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||23.27|1.26|
73919620|NCT01529346|147367019|SUPERIORITY_OR_OTHER||LS Mean Difference|4.18|STANDARD_ERROR_OF_MEAN|6.66|||TWO_SIDED|90.0|-6.82|15.18||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||15.18|-6.82|
73919621|NCT01529346|147367019|SUPERIORITY_OR_OTHER||LS Mean Difference|12.57|STANDARD_ERROR_OF_MEAN|6.69|||TWO_SIDED|90.0|1.52|23.61||||||||23.61|1.52|
73919622|NCT01529346|147367019|SUPERIORITY_OR_OTHER||LS Mean Difference|32.56|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|90.0|20.51|44.61||||||||44.61|20.51|
73919623|NCT01529346|147367020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.6|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.5|0.6|
73919624|NCT01529346|147367020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|90.0|0.9|1.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.9|0.9|
73919625|NCT01529346|147367020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.7|1.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.6|0.7|
73919626|NCT01529346|147367020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6|||||TWO_SIDED|90.0|1.0|2.4||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.4|1.0|
73919627|NCT01529346|147367021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|90.0|1.1|3.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||3.8|1.1|
73919628|NCT01529346|147367021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6|||||TWO_SIDED|90.0|1.4|4.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||4.9|1.4|
73919629|NCT01529346|147367021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.2|||||TWO_SIDED|90.0|1.1|4.1||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||4.1|1.1|
73919630|NCT01529346|147367021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.3|||||TWO_SIDED|90.0|2.8|9.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||9.9|2.8|
73919631|NCT01529346|147367022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|90.0|0.4|1.0||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.0|0.4|
73919632|NCT01529346|147367022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.5|1.2||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.2|0.5|
73919633|NCT01529346|147367022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||||TWO_SIDED|90.0|0.3|0.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||0.8|0.3|
73919634|NCT01529346|147367022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|90.0|0.2|0.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||0.6|0.2|
73919635|NCT00106392|147367031|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-Values were not adjusted.|Wilcoxon (Mann-Whitney)|||A group sequential design using the O'Brien and Fleming stopping rule will require 58 evaluable patients per group to detect a 5-point difference in the Erectile Function domain of the IIEF with a power of 80% and an overall significance level of 5%.||||0.111
73919636|NCT00106392|147367032|SUPERIORITY_OR_OTHER|||||||0.453||95.0|||||Fisher Exact|||||||0.453
73919637|NCT00106392|147367033|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.790
74027910|NCT03551522|147609347|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|7.78||||0.2313|TWO_SIDED|95.0|-5.01|20.58|||ANCOVA|||||20.58|-5.01|0.2313
74027911|NCT03165981|147609356|SUPERIORITY||Risk Ratio (RR)|0.87||||0.7588|TWO_SIDED|95.0|0.36|2.1|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.10|0.36|0.7588
73919638|NCT00106392|147367034|SUPERIORITY_OR_OTHER|||||||0.099||95.0|||||Fisher Exact|||||||0.099
73919639|NCT00106392|147367035|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.575
73919640|NCT00106392|147367036|SUPERIORITY_OR_OTHER|||||||0.879||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.879
73919641|NCT03454581|147367037|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
73919642|NCT03454581|147367038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
73919643|NCT03454581|147367039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
73919644|NCT03454581|147367040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Generalized Estimating Equation|||||||<0.05
73919645|NCT03454581|147367041|OTHER||||||<|0.01|||||||Generalized Estimating Equation|||||||<0.01
74086627|NCT01011556|147726710|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.87|||<|0.001|TWO_SIDED|90.0|-5.006|-2.727|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-2.727|-5.006|<0.001
73919646|NCT03454581|147367042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
73919647|NCT03454581|147367043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
73919648|NCT03454581|147367044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
73919649|NCT00589914|147367045|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5 points in the change in PANSS total score i.e., lower limit of the 95% CI for difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) had to be greater than -5 to demonstrate non-inferiority.|Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-1.62|2.38||No p-value to report.|ANCOVA|ANCOVA model with factors treatment, country and baseline score. Weighted approach used to account for interim analysis for sample size re-estimation.||Null hypothesis: Difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) for the mean change from baseline to endpoint in PANSS total score (LOCF) was less than or equal to -5 (prespecified non-inferiority margin). Sample size: SD of 20 for the change in PANSS total score, a true difference between treatment groups of 0.1 in favor of RISPERDAL CONSTA, 2-sided significance level of 5%, and 80% power. A sample size reestimation was performed when 60% of the data was available.||2.38|-1.62|
73919650|NCT00589914|147367046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.07|0.17||No P-values reported.|ANCOVA|||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.||0.17|-0.07|
73919651|NCT00589914|147367047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-1.22|1.69||No P-values reported.|ANCOVA|||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.||1.69|-1.22|
73919652|NCT01737944|147367048|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A - SC injection with the Vibex MTX device and Treatment B - SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.24|||||TWO_SIDED|90.0|92.33|100.31||||||||100.31|92.33|
73919653|NCT01737944|147367048|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.28|||||TWO_SIDED|90.0|97.17|105.56||||||||105.56|97.17|
73919654|NCT01737944|147367049|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.22|||||TWO_SIDED|90.0|92.32|100.28||||||||100.28|92.32|
73919655|NCT01737944|147367049|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.14|||||TWO_SIDED|90.0|97.06|105.4||||||||105.40|97.06|
73919656|NCT01737944|147367050|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.76|||||TWO_SIDED|90.0|87.93|106.47||||||||106.47|87.93|
74086628|NCT01011556|147726710|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.56|||<|0.001|TWO_SIDED|90.0|-4.652|-2.464|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-2.464|-4.652|<0.001
73919657|NCT01737944|147367050|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|89.79|||||TWO_SIDED|90.0|81.61|98.78||||||||98.78|81.61|
73919658|NCT03590041|147367061|SUPERIORITY|||||||0.04||||||Linear Mixed Model adjusted for a priori patient covariates: Race/Ethnicity, Gender, Health Literacy, Food Availability, Charlson Score, Mental Illness, Substance use. Adjusted P-value represents the significance test for the time x group interaction|Mixed Models Analysis|||We hypothesized that patients in Patient-Driven SMAs would have greater reductions in Diabetes Distress than those in Standardized SMAs. We expected seeing an effect size of a .6 unit decrease (.30) in Standardized SMAs and 1.2 unit decrease (.60) in Patient-Driven SMAs. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).||||0.04
73919659|NCT03590041|147367062|SUPERIORITY|||||||0.82||||||Linear Mixed Model adjusted for a priori patient covariates: Race/Ethnicity, Gender, Health Literacy, Food Availability, Charlson Score, Mental Illness, Substance use. Adjusted P-value represents the significance test for the time x group interaction|Mixed Models Analysis|||We hypothesized that patients in the Patient-Driven condition would have a greater reduction in HbA1c than patients in the Standardized condition. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).||||0.82
73919660|NCT02533427|147367063|OTHER||% Geometric Least Square Mean(GLSM)Ratio|107.36|||||TWO_SIDED|90.0|103.19|111.69|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||111.69|103.19|
73919661|NCT02533427|147367064|OTHER||% GLSM Ratio|115.14|||||TWO_SIDED|90.0|106.49|124.5|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||124.50|106.49|
73919662|NCT02533427|147367065|OTHER||% GLSM Ratio|105.43|||||TWO_SIDED|90.0|96.95|114.66|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||114.66|96.95|
73919663|NCT02533427|147367066|OTHER||% GLSM Ratio|248.89|||||TWO_SIDED|90.0|33.11|1870.81|||||Test/Reference: Norgestimate Part B/Part A|Norgestimate Part B/Part A||1870.81|33.11|
73919664|NCT02533427|147367067|OTHER||% GLSM Ratio|107.71|||||TWO_SIDED|90.0|97.78|118.65|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||118.65|97.78|
73919665|NCT02533427|147367068|OTHER||% GLSM Ratio|115.02|||||TWO_SIDED|90.0|108.12|122.37|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||122.37|108.12|
73919666|NCT02533427|147367069|OTHER||% GLSM Ratio|121.06|||||TWO_SIDED|90.0|106.1|138.12|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||138.12|106.10|
73967078|NCT02596126|147471236|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI). If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.76|||<|0.025|TWO_SIDED|95.0|0.6|0.96|||Regression, Cox|||||0.96|0.6|< 0.025
74086629|NCT01011556|147726711|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-4.53|STANDARD_ERROR_OF_MEAN|0.687|<|0.001|TWO_SIDED|90.0|-5.663|-3.392||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-3.392|-5.663|<0.001
73919667|NCT02533427|147367070|OTHER||% GLSM Ratio|112.11|||||TWO_SIDED|90.0|87.19|144.14|||||Test/Reference: Norgestimate Part B/Part A|Norgestimate Part B/Part A||144.14|87.19|
73919668|NCT02533427|147367071|OTHER||% GLSM Ratio|114.19|||||TWO_SIDED|90.0|107.4|121.39|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||121.39|107.40|
73919669|NCT02533427|147367072|OTHER||% GLSM Ratio|121.62|||||TWO_SIDED|90.0|110.85|133.44|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||133.44|110.85|
73919670|NCT02533427|147367073|OTHER||% GLSM Ratio|92.86|||||TWO_SIDED|90.0|82.55|104.45|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||104.45|82.55|
73919671|NCT01124422|147367090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.6|STANDARD_ERROR_OF_MEAN|20.58||0.181|TWO_SIDED|95.0|-68.2|13.0||ANCOVA model with terms for treatment, investigator, Oxycon stratum, and baseline value|ANCOVA|||||13.0|-68.2|0.181
73919672|NCT02959944|147367109|SUPERIORITY||Difference in Rates|0.043||||0.5384|TWO_SIDED|95.0|-0.094|0.181||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.181|-0.094|0.5384
73919673|NCT02959944|147367110|SUPERIORITY||Difference in Rates|0.043||||0.5384|TWO_SIDED|95.0|-0.094|0.181||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.181|-0.094|0.5384
73919674|NCT02959944|147367111|SUPERIORITY|||||||0.324||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.324
73919675|NCT02959944|147367112|SUPERIORITY|||||||0.281||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.281
73919676|NCT02959944|147367113|SUPERIORITY|||||||0.275||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.275
73919677|NCT02959944|147367114|SUPERIORITY|||||||0.216||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.216
73919678|NCT02959944|147367115|SUPERIORITY||Difference in Rates|-0.067||||0.351|TWO_SIDED|95.0|-0.208|0.074||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.074|-0.208|0.3510
73919679|NCT02959944|147367116|SUPERIORITY||Difference in Rates|-0.067||||0.351|TWO_SIDED|95.0|-0.208|0.074||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.074|-0.208|0.3510
73919680|NCT02959944|147367117|SUPERIORITY||Difference in Rates|0.124||||0.0659|TWO_SIDED|95.0|-0.007|0.256||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.256|-0.007|0.0659
73919681|NCT02959944|147367118|SUPERIORITY||Difference in Rates|0.125||||0.0708|TWO_SIDED|95.0|-0.01|0.261||P-value is computed using non-stratified Chi-Square test.|Chi-squared|||||0.261|-0.010|0.0708
73967079|NCT02596126|147471236|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
74027912|NCT03165981|147609357|SUPERIORITY||Risk Ratio (RR)|0.97||||0.9412|TWO_SIDED|95.0|0.39|2.4|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.40|0.39|.9412
73919682|NCT02959944|147367119|SUPERIORITY||Difference in Rates|-0.059||||0.4064|TWO_SIDED|95.0|-0.199|0.08||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval was computed using normal approximation.|||0.080|-0.199|0.4064
74027913|NCT03165981|147609358|SUPERIORITY|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.||||||0.3408
74027914|NCT03165981|147609359|SUPERIORITY||Risk Ratio (RR)|0.87||||0.8325|TWO_SIDED|95.0|0.24|3.13|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||3.13|0.24|0.8325
74027915|NCT03165981|147609360|SUPERIORITY|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.||||||0.3408
74027916|NCT03165981|147609361|SUPERIORITY||Risk Ratio (RR)|0.73||||0.6101|TWO_SIDED|95.0|0.21|2.48|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.48|0.21|0.6101
74027917|NCT03165981|147609362|SUPERIORITY|||||||0.848|||||||Wilcoxon (Mann-Whitney)|||||||0.848
74086630|NCT01011556|147726711|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.94|STANDARD_ERROR_OF_MEAN|0.692|<|0.001|TWO_SIDED|90.0|-5.086|-2.8||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-2.800|-5.086|<0.001
74086631|NCT01011556|147726711|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.53|STANDARD_ERROR_OF_MEAN|0.665|<|0.001|TWO_SIDED|90.0|-4.627|-2.43||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-2.430|-4.627|<0.001
73919683|NCT02959944|147367120|SUPERIORITY||Difference in Rates|-0.049||||0.4955|TWO_SIDED|95.0|-0.188|0.091||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval was computed using normal approximation.|||0.091|-0.188|0.4955
73919684|NCT02959944|147367121|SUPERIORITY||Hazard Ratio (HR)|0.994|||||TWO_SIDED|95.0|0.507|1.949|||||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|||1.949|0.507|
73919685|NCT02959944|147367122|SUPERIORITY||Hazard Ratio (HR)|1.061|||||TWO_SIDED|95.0|0.591|1.904|||||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|||1.904|0.591|
73919686|NCT02959944|147367123|SUPERIORITY||Hazard Ratio (HR)|0.697||||0.101|TWO_SIDED|95.0|0.451|1.076|||Regression, Cox|||||1.076|0.451|0.1010
73919687|NCT02959944|147367124|SUPERIORITY||Hazard Ratio (HR)|0.717||||0.1004|TWO_SIDED|95.0|0.482|1.068|||Regression, Cox|||||1.068|0.482|0.1004
73919688|NCT01830699|147367204|NON_INFERIORITY_OR_EQUIVALENCE|For details of power calculation, see above. Using a minimal clinical importance of -9.1, the null hypothesis was a mean difference less than -9.1.|Mean Difference (Final Values)|-23.9||||0.004|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."||||0.004
73919689|NCT01830699|147367205|NON_INFERIORITY_OR_EQUIVALENCE|See details above regarding effect size, power, etc.||||||0.044|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."||||0.044
73919690|NCT00558025|147367209|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: -15 %, power: 80%|Risk Difference (RD)|-10.75||||||95.0|-20.51|1.48|||Wilson score interval|||Successfully switched patients||1.48|-20.51|
73919691|NCT00558025|147367209|SUPERIORITY_OR_OTHER|||||||0.0803||95.0|||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.0803
73919692|NCT00558025|147367210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.2061||95.0|-2.8|0.6|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.6|-2.8|0.2061
73919693|NCT00558025|147367211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.4694||95.0|-0.8|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.4|-0.8|0.4694
73919694|NCT00558025|147367212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.1804||95.0|-2.3|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.4|-2.3|0.1804
73919695|NCT00558025|147367213|SUPERIORITY_OR_OTHER|||||||0.1623|||||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.1623
73919696|NCT00558025|147367214|SUPERIORITY_OR_OTHER|||||||0.1299|||||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.1299
73919697|NCT00558025|147367215|SUPERIORITY_OR_OTHER|||||||0.619||95.0|||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.6190
73919698|NCT02135146|147367226|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
73919699|NCT02135146|147367226|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
74086632|NCT01011556|147726711|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-7.5|STANDARD_ERROR_OF_MEAN|0.818|<|0.001|TWO_SIDED|90.0|-8.856|-6.151||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-6.151|-8.856|<0.001
73919700|NCT00010374|147367232|OTHER|Performance goal of 35%|Exact two-sided binomial test|96.2|||<|0.001|TWO_SIDED|95.0|87.0|99.5|||Exact two-sided binomial test|||||99.5|87.0|<0.001
73919701|NCT02205814|147367304|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures|||||||<0.05
73919702|NCT02205814|147367305|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures|||All secondary efficacy variables were analysed on the ITT population only. Multiplicity was adjusted using the Hochberg procedure. The continuous secondary efficacy variables were analysed over time and were treated in the same way as the primary efficacy variable with respective output.||||<0.05
73919703|NCT00143403|147367308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.67|1.2|||||HR: Irinotecan+5-FU/FA / 5-FU/FA|||1.20|0.67|
73919704|NCT00143403|147367308|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Log Rank|||||||0.468
73919705|NCT00514540|147367310|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005|ONE_SIDED|95.0||||"Stoppage of trial early if 1) probability of response with the frontline treatment DC in the 1st 2 courses is unacceptably low compared to a target of 30% Pr(p1\*p2 \> .30\|data) \< 0.005, or 2) risk of a SAE is unacceptably high Pr(m \> m\* \|data) \< 0.001"|Bayesian probability model|Operating Characteristics of futility monitoring rule 1 \& safety monitoring rule 2 applied simultaneously for frontline treatment DC in courses 1 \& 2.||Disease status evaluated at the end of course 1 \& the end of course 2. Primary outcomes are response, defined as the absence of disease progression, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death. Bayesian probability model \& decision rules used to monitor patient outcomes.||||< 0.005
73919706|NCT02326025|147367317|SUPERIORITY||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.964|1.13|||||Log(PK) is participant and treatment and random error, where participant is fitted as a random effect.|||1.13|0.964|
73967080|NCT02596126|147471237|EQUIVALENCE|Treatment adherence is measured at visit 1 (6 months) and visit 3 (24 months) using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group. The distributions of the MMAS-8 score at 6 months and 24 months will be compared between treatment groups using an ordinal logistic regression model.|Risk Ratio (RR)|1.13|||<|0.005|TWO_SIDED|95.0|1.06|1.2|||Chi-squared|||Statistical analysis title - Treatment adherence at 6 months||1.2|1.06|< 0.005
73967081|NCT02596126|147471238|SUPERIORITY|Time to first event will be investigated using Cox proportional hazards regression. Hazard ratios and 95% confidence intervals will be obtained from the Cox proportional hazards model. P-values will be obtained using the log-rank test.|Hazard Ratio (HR)|0.97|||<|0.05|TWO_SIDED|95.0|0.75|1.25|||Log Rank|||Statistical analysis title - All-cause death||1.25|0.75|< 0.05
73967082|NCT02596126|147471239|EQUIVALENCE|Treatment adherence is measured at visit 1 (6 months) and visit 3 (24 months) using the Morisky- Medication Adherence Scale (8 item) Questionnaire (MMAS-8). The number and percentage of patients with low (0-5), medium (6-7) and high(8) adherence will be reported by treatment group. The distributions of the MMAS-8 score at 6 months and 24 months will be compared between treatment groups using an ordinal logistic regression model.|Hazard Ratio (HR)|1.17|||<|0.005|TWO_SIDED|95.0|1.1|1.25|||Chi-squared|||Statistical analysis title - Treatment adherence at 24 months||1.25|1.1|< 0.005
73967083|NCT02596126|147471240|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.3|||<|0.05|TWO_SIDED|95.0|-1.8|1.2||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 6 months||1.2|-1.8|< 0.05
73967084|NCT02596126|147471241|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|1.4|||<|0.05|TWO_SIDED|95.0|-0.1|3.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 12 months||3|-0.1|< 0.05
73919707|NCT02326025|147367317|SUPERIORITY||Ratio of LS Means|1.03|||||TWO_SIDED|90.0|0.957|1.11||||||||1.11|0.957|
73919708|NCT02326025|147367318|SUPERIORITY||Ratio of LS Means|0.944|||||TWO_SIDED|90.0|0.77|1.16||||||||1.16|0.770|
73967085|NCT02596126|147471242|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.1|||<|0.05|TWO_SIDED|95.0|-1.7|1.4||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 24 months||1.4|-1.7|< 0.05
73967086|NCT02596126|147471243|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|95.0|-0.7|1.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 6 months||1|-0.7|< 0.05
74027918|NCT03165981|147609364|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
74027919|NCT03191396|147609405|NON_INFERIORITY|HbA1c non-inferiority was tested using a non-inferiority margin of 0.3.|Treatment difference|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.56||The non-inferiority p-value is calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3.|ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|The responses are analysed using an ANCOVA with treatment and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.||-0.56|-0.82|<0.0001
74027920|NCT03191396|147609405|SUPERIORITY||Treatment difference|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.56|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|||-0.56|-0.82|<0.0001
73919709|NCT02326025|147367318|SUPERIORITY||Ratio of LS Means|1.03|||||TWO_SIDED|90.0|0.801|1.33||||||||1.33|0.801|
73919710|NCT03178903|147367337|SUPERIORITY||Mean Difference (Final Values)|0.678||||0.87|TWO_SIDED|||||p\<.05 was the a priori threshold for statistical significance.|ANCOVA|Covarying for baseline depressive symptoms and MVPA.||||||.87
73919711|NCT00060008|147367338|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
73919712|NCT00560859|147367357|SUPERIORITY_OR_OTHER||difference of change from baseline|2.0||||0.16|||||||ANCOVA|||||||0.16
73919713|NCT01846611|147367360|SUPERIORITY||Hazard Ratio (HR)|0.925|||=|0.5236|TWO_SIDED|95.0|0.727|1.177|||Unstratified log rank test|||||1.177|0.727|= 0.5236
73919714|NCT01846611|147367361|SUPERIORITY||Hazard Ratio (HR)|0.935|||=|0.5174|TWO_SIDED|95.0|0.762|1.147|||Unstratified log rank test|||||1.147|0.762|= 0.5174
73919715|NCT01846611|147367362|SUPERIORITY||Odds Ratio (OR)|1.523|||=|0.0142|TWO_SIDED|95.0|1.075|2.158|||Fisher Exact|||||2.158|1.075|= 0.0142
73919716|NCT00662363|147367363|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||independent sample t test|||Primary outcome measures chosen were between group comparisons for change on Constipation Symptom Questionnaire ratings at exit from the study. The PAC-SYM is a symptom scale where higher numbers indicate more symptoms. Change from baseline to Day 7 was calculated and larger negative differences indicated greater improvement in constipation symptoms. The PAC-QOL is a quality of life scale where higher numbers indicate better quality of life. Change from baseline to 7 days was calculated.||||<0.05
73919717|NCT01428453|147367384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|39.8||||0.133|TWO_SIDED|95.0|-12.4|92.0|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-42 and Age.|Comparison of CSF Abeta42 between placebo and rilapladib 250 mg.|||92.0|-12.4|0.133
73919718|NCT01428453|147367384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-250.3|STANDARD_ERROR_OF_MEAN|265.66||0.829|TWO_SIDED|95.0|-771.9|271.2|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-40 and Age.|Comparison of CSF Abeta40 between placebo and rilapladib 250 mg.|||271.2|-771.9|0.829
73919719|NCT01428453|147367385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|||||TWO_SIDED|95.0|-0.003|0.036|||||The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Ratio Abeta1-42/Abeta1-40 and Age.|||0.036|-0.003|
73919720|NCT01428453|147367386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.1|STANDARD_ERROR_OF_MEAN|44.4||0.902|TWO_SIDED|95.0|-144.5|30.3|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF tau and Age.|Comparison of CSF tau between placebo and rilapladib 250 mg.|||30.3|-144.5|0.902
74027921|NCT03191396|147609406|SUPERIORITY||Treatment difference|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.57|-3.09|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|||-3.09|-4.57|<0.0001
74027922|NCT02435173|147609471|SUPERIORITY||Adjusted means difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06||0.0012|TWO_SIDED|95.0|-0.37|-0.11|||ANCOVA|Treatment as a fixed effect and log10 transformed baseline SPD as a covariate.||||-0.11|-0.37|0.0012
74086633|NCT01011556|147726711|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-7.46|STANDARD_ERROR_OF_MEAN|0.83||0.001|TWO_SIDED|90.0|-8.835|-6.091||p-value for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-6.091|-8.835|0.001
74086634|NCT01011556|147726711|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-6.19|STANDARD_ERROR_OF_MEAN|0.802||0.001|TWO_SIDED|90.0|-7.51|-4.86||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-4.860|-7.510|0.001
74086635|NCT01011556|147726712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
73919721|NCT01428453|147367386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|2.46||0.892|TWO_SIDED|95.0|-7.9|1.8|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF P-tau and Age.|Comparison of P-tau between placebo and rilapladib 250 mg.|||1.8|-7.9|0.892
74086636|NCT01011556|147726712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
74086637|NCT01011556|147726712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
74086638|NCT01011556|147726712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
74086639|NCT01011556|147726712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
74086640|NCT01011556|147726712|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||0.003
74086641|NCT01011556|147726712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
73919722|NCT01428453|147367387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.167||||0.026|TWO_SIDED|95.0|0.021|0.313||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Working Memory/Executive Function Composite Score, Treatment by Visit and Baseline Working Memory/Executive Function Composite Score by Visit.|Mixed-Model Repeated Measures analysis||A positive treatment difference indicates benefit, relative to placebo.|||0.313|0.021|0.026
73919723|NCT01428453|147367388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.256||0.828|TWO_SIDED|95.0|-0.74|0.26|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Albumin Quotient and Age.||||0.26|-0.74|0.828
73919724|NCT01428453|147367389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.9|1.2|||Mixed-Model Repeated Measures analysis||Comparison of Abeta42 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||1.2|-3.9|
73919725|NCT01428453|147367389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||||95.0|-10.2|12.2|||Mixed-Model Repeated Measures analysis||Comparison of Abeta40 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||12.2|-10.2|
73919726|NCT01428453|147367390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|||||TWO_SIDED|95.0|-0.016|0.01|||Mixed-Model Repeated Measures analysis||The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||0.010|-0.016|
74027923|NCT02435173|147609472|SUPERIORITY||Adjusted means difference|40.13|STANDARD_ERROR_OF_MEAN|5.04|<|0.0001|TWO_SIDED|95.0|28.51|51.75|||ANCOVA|Treatment as a fixed effect and baseline as a covariate.||||51.75|28.51|<0.0001
74086642|NCT01011556|147726712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
74086643|NCT01011556|147726712|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.029
74086644|NCT01011556|147726712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||<0.001
74086645|NCT01011556|147726712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||<0.001
74086646|NCT01011556|147726712|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.047
74086647|NCT01011556|147726713|SUPERIORITY_OR_OTHER|||||||0.822||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.822
73919727|NCT01428453|147367392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.067|||||TWO_SIDED|95.0|-0.191|0.057|||Mixed-Model Repeated Measures analysis||"The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit. A positive treatment difference indicates benefit, relative to placebo.~placebo."|||0.057|-0.191|
73919728|NCT01428453|147367392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138||||0.982|TWO_SIDED|95.0|0.01|0.267||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Overall Composite Score, Treatment by Visit and Baseline Overall Composite Score by Visit.|Mixed-Model Repeated Measures analysis|The probability (effect size) for change from Baseline in CogState battery overall composite score \>0 is presented.|A positive treatment difference indicates benefit, relative to placebo. Comparison of overall composite score between placebo and rilapladib 250 mg at Week 24.|||0.267|0.010|0.982
73919729|NCT01428453|147367393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.063|||||TWO_SIDED|95.0|-0.257|0.13|||Mixed-Model Repeated Measures analysis|The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit.|Comparison of attention composite score between placebo and rilapladib 250 mg at Week 12. A positive treatment difference indicates benefit, relative to placebo.|||0.130|-0.257|
73919730|NCT01428453|147367393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.13|0.269|||Mixed-Model Repeated Measures analysis|The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit.|Comparison of attention composite score between placebo and rilapladib 250 mg at Week 24. A positive treatment difference indicates benefit, relative to placebo.|||0.269|-0.130|
73919731|NCT02607033|147367398|OTHER|Wilxocon signed Rank test||||||0.028|||||||Wilxocon signed Rank test|||Wilxocon signed Rank test to compare pre to post onset of pain time in the Exercise + Weight loss group. Due to low sample size were unable to compare changes between the Exercise + Weight Loss group and the Exercise only groups.||||0.028
73919732|NCT02421315|147367402|OTHER|a t-test comparing groups in a specific region-of-interest (ROI); the insula|Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.057||0.0585|TWO_SIDED|95.0|-0.004|0.224|||t-test, 2 sided|||We hypothesized that compared to HC, children and adolescents with OCD would have increased activation in subcortical structures (insula, and putamen) comprising a right hemisphere dorsal frontostriatal circuit.||0.224|-0.004|0.0585
73919733|NCT02421315|147367403|SUPERIORITY|We selected 'arbitrary units' as the unit of measure here because we are looking at connectivity strengths|Mean Difference (Final Values)|0.49512921|STANDARD_ERROR_OF_MEAN|0.06553315||0.037|TWO_SIDED|||||"NBS controls for family-wise error rate using permutation testing to identify components or clusters of contiguous region-to-region connections. A statistical threshold of p\<.05 with 20,000 permutations was used."|t-test, 1 sided||Direction of the comparison: HC\>OCD|Whole-Brain Connectome-Level Analyses were performed on the FC-strength indices between 352 regions. Edge-wise functional connectivity analyses was then be conducted across the resulting matrix comprised of 352 nodes and 123,904 edges, using the Network-Based Statistics (NBS) Toolbox. We hypothesized that youth with OCD would show altered FC between task-control circuit regions.||||.037
73919734|NCT02421315|147367403|OTHER||Slope|-0.521|||<|0.05|TWO_SIDED||||||Regression, Linear|||Separate cross-lagged panel models were computed in the OCD group for the three functional connections that differed significantly across groups at baseline (see Statistical Analysis 1). These models were constructed using IBM SPSS Amos (v.23) to test for directional relationships between OCD symptoms and FC pre- to post-treatment in the OCD patients. CY-BOCS total scores at each time point were used as the OCD symptoms measure.||||<.05
73919735|NCT02421315|147367404|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.0464|TWO_SIDED|95.0|0.0018|0.218|||t-test, 2 sided|||||0.218|0.0018|0.0464
73919736|NCT02421315|147367405|SUPERIORITY|only participants were assigned to groups (OCD, HC) and we measured streamline count in these participants to index structural connectivity|Slope|-102.67|||<|0.025|TWO_SIDED|||||"NBS controls for family-wise error rate using permutation testing to identify components or clusters of contiguous region-to-region connections. A statistical threshold of p=.025 with 10,000 permutations was used."|Regression, Linear||Direction of comparison: HC\>OCD|Whole-Brain Connectome-Level Analyses were performed on the structural connectivity indices (streamline count) between 164 regions. Edge-wise structural connectivity analyses was then be conducted across the resulting matrix comprised of 164 nodes and 26,896 edges, using the Network-Based Statistics (NBS) Toolbox.||||<0.025
73919737|NCT04346537|147367417|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< 0.001
73919738|NCT04346537|147367418|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< 0.001
73919739|NCT04346537|147367419|OTHER|Two-one sided t-tests (TOST) -- the 90% confidence interval was required to be contained with 300 and 1300 ohms.|||||<|0.001|||||||Two one-sided t-tests|||||||< 0.001
73919740|NCT01134783|147367420|SUPERIORITY_OR_OTHER|||||||0.707|TWO_SIDED|||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic|||||||0.707
73919741|NCT01134783|147367421|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic|||||||0.049
73919742|NCT02423577|147367446|SUPERIORITY||Risk Ratio (RR)|1.14||||0.1436|TWO_SIDED|90.0|0.98|1.31|||Chi-squared|||||1.31|0.98|0.1436
74027924|NCT03216265|147609488|OTHER||Least Square Mean difference|-1.44|||<|0.0001|TWO_SIDED|95.0|-2.1|-0.78|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of body as fixed effects, and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline (Visit 2) minus the second named treatment adjusted mean change from baseline (Visit 2).|||-0.78|-2.10|<0.0001
74027925|NCT03952546|147609507|NON_INFERIORITY|The test for non-inferiority was carried out by calculating the upper 95% confidence limit (one sided confidence interval) for the difference in estimated blood loss (δ = Unipolar electrocautery system - Saline-coupled bipolar sealer), with the margin of inferiority (δ), set at 200 cc.||||||0.1254|||||||t-test, 1 sided|||||||0.1254
74027926|NCT03952546|147609508|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74027927|NCT01650779|147609510|SUPERIORITY_OR_OTHER|||||||0.0002|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.||||0.0002
74027928|NCT01650779|147609510|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.||||<0.0001
74027929|NCT01650779|147609510|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.||||<0.0001
74027930|NCT01650779|147609511|SUPERIORITY_OR_OTHER|||||||0.1178|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.||||0.1178
74027931|NCT01650779|147609511|SUPERIORITY_OR_OTHER|||||||0.1176|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.||||0.1176
74027932|NCT01650779|147609511|SUPERIORITY_OR_OTHER|||||||0.0322|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.||||0.0322
74027933|NCT01650779|147609512|SUPERIORITY_OR_OTHER|||||||0.5811|||||||One sample test of median (sign test)|||Baseline versus Month 2: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.5811
74027934|NCT01650779|147609512|SUPERIORITY_OR_OTHER|||||||0.7744|||||||One sample test of median (sign test)|||Baseline versus Month 4: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.7744
73919743|NCT02392247|147367450|SUPERIORITY_OR_OTHER||Slope|0.34|||<|0.001|TWO_SIDED|95.0|0.26|0.44||This study was not designed to determine which method is 'superior'.Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming Regression||Slope measured deviation from 1:1 concordance between SEER and TEG with TEG measurement as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements)||0.44|0.26|<0.001
73919744|NCT02392247|147367451|SUPERIORITY_OR_OTHER||Slope|3.1|||<|0.001|TWO_SIDED|95.0|2.9|3.4||This study was not designed to determine which method is 'superior'. Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming regression|Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|Slope measured deviation from 1:1 concordance between SEER and TEG with TEG as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements )||3.4|2.9|<0.001
73919745|NCT03010254|147367452|SUPERIORITY||Least Squares Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.021|<|0.001|TWO_SIDED|95.0|-0.18|-0.097||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.097|-0.180|<0.001
73919746|NCT03010254|147367454|NON_INFERIORITY|Non-inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.037|STANDARD_ERROR_OF_MEAN|0.0115|||ONE_SIDED|97.5||0.059|||||Least squares mean difference (DFT015 - SN60WF).The 1-sided 97.5% Upper Confidence Limit is presented.|||0.059||
73919747|NCT03010254|147367455|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.0216|<|0.001|TWO_SIDED|95.0|-0.133|-0.048||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.048|-0.133|<0.001
73919748|NCT03010254|147367456|OTHER||Mean difference in depth of focus|0.52|||||TWO_SIDED|||||Hypothesis testing was not pre-specified.|||Mean difference in depth of focus (DFT015 - SN60WF)|||||
73919749|NCT03010254|147367457|NON_INFERIORITY|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.179|STANDARD_ERROR_OF_MEAN|0.0551|||ONE_SIDED|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|Without glare|||-0.287|
73919750|NCT03010254|147367457|NON_INFERIORITY|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.181|STANDARD_ERROR_OF_MEAN|0.0541|||ONE_SIDED|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|With glare|||-0.287|
73919751|NCT03010254|147367458|SUPERIORITY||Difference in percentage|20.2|||||TWO_SIDED|95.0|8.77|31.04|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||31.04|8.77|
73919752|NCT03010254|147367459|SUPERIORITY||Percent difference|21.7|||||TWO_SIDED|95.0|7.92|35.06|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||35.06|7.92|
73919753|NCT01404325|147367460|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73919754|NCT02144233|147367489|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
74027935|NCT01650779|147609512|SUPERIORITY_OR_OTHER|||||||0.3877|||||||One sample test of median (sign test)|||Baseline versus Month 6: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.3877
74027936|NCT02747043|147609527|EQUIVALENCE|Clinical equivalence of the primary endpoint will first be demonstrated by comparing the 1-sided 95% lower confidence limit of the RD of ORR by week 28 between ABP 798 and rituximab with a noninferiority margin of -15%. If this is successful, the 1-sided upper 95% confidence limit of the RD of ORR by week 28 will be compared with a nonsuperiority margin of +35.5%.|Risk Difference (RD)|7.7|||||TWO_SIDED|90.0|-1.4|16.8|||||The 2-sided 90% confidence limits of the risk difference (RD) of ORR by week 28 used a generalized linear model adjusted for the stratification factors (geographic region and age group).|||16.8|-1.4|
74027937|NCT02747043|147609527|OTHER||Risk Difference (RD)|7.7|||||TWO_SIDED|95.0|-3.2|18.6||||||||18.6|-3.2|
74086648|NCT01011556|147726713|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.406
73967087|NCT02596126|147471244|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.8|||<|0.05|TWO_SIDED|95.0|-0.1|1.6||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 12 months||1.6|-0.1|< 0.05
73967088|NCT02596126|147471245|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.9|1.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 24 months||1|-0.9|< 0.05
73967089|NCT02596126|147471246|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|2.1|||<|0.05|TWO_SIDED|95.0|-0.2|4.4|||ANCOVA|||Statistical analysis title - LDL cholesterol - 12 months||4.4|-0.2|< 0.05
73967090|NCT02596126|147471247|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.1|||<|0.05|TWO_SIDED|95.0|-2.5|2.4|||ANCOVA|||Statistical analysis title - LDL cholesterol - 24 months||2.4|-2.5|< 0.05
73967091|NCT02596126|147471248|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.7|||<|0.025|TWO_SIDED|95.0|0.54|0.9|||Regression, Cox|||||0.90|0.54|< 0.025
74086649|NCT01011556|147726713|SUPERIORITY_OR_OTHER|||||||0.312||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.312
73967092|NCT02596126|147471248|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
73967093|NCT02596126|147471249|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.67|||<|0.025|TWO_SIDED|95.0|0.47|0.97|||Regression, Cox|||||0.97|0.47|< 0.025
73967094|NCT02596126|147471249|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
73967095|NCT02596126|147471250|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.71|||<|0.025|TWO_SIDED|95.0|0.48|1.05|||Regression, Cox|||||1.05|0.48|< 0.025
73967096|NCT02596126|147471250|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
74027938|NCT02747043|147609528|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|90.0|-9.3|11.2||||||The 2-sided 90% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).||11.2|-9.3|
74027939|NCT02747043|147609528|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-11.3|13.2||||||The 2-sided 95% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).||13.2|-11.3|
74027940|NCT02747043|147609534|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-8.3|16.3||||||Percentage risk difference for 'Any adverse event of interest'||16.3|-8.3|
74027941|NCT02747043|147609534|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-12.1|12.3||||||Percentage risk difference for 'Infusion reactions including hypersensitivity'||12.3|-12.1|
74027942|NCT02747043|147609534|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-11.8|13.0||||||Percentage risk difference for 'Hematological reactions'||13.0|-11.8|
74027943|NCT02747043|147609534|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-11.8|13.2||||||Percentage risk difference in 'Cardiac disorders'||13.2|-11.8|
74086650|NCT01011556|147726713|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
73919755|NCT02068443|147367531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|95.0|-0.821|-0.48|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin alone (Metformin QD - Alogliptin alone).|||-0.480|-0.821|
73919756|NCT02068443|147367531|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority of Alogliptin + Metformin Hydrochloride QD to Alogliptin + Metformin Hydrochloride BID.|LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.069|||TWO_SIDED|95.0|-0.026|0.247|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin + Metformin Hydrochloride BID (Metformin QD - Metformin BID).|||0.247|-0.026|
73919757|NCT01986855|147367541|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.03||||0.807|TWO_SIDED|95.0|-0.23|0.18||The cLDA model included fixed effects for treatment, time, eGFR stratum (\<45 or ≥45 mL/min/1.73m\^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.18|-0.23|0.807
73919758|NCT01986855|147367541|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.15||||0.155|TWO_SIDED|95.0|-0.35|0.06||The cLDA model included fixed effects for treatment, time, eGFR stratum (\<45 or ≥45 mL/min/1.73m\^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.06|-0.35|0.155
73919759|NCT01986855|147367542|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|3.6|||||TWO_SIDED|95.0|-4.8|12.1|||||Miettinen \& Nurminen Method|||12.1|-4.8|
73919760|NCT01986855|147367542|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-7.0|||||TWO_SIDED|95.0|-16.3|2.3|||||Miettinen \& Nurminen Method|||2.3|-16.3|
73919761|NCT01986855|147367543|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|3.0|||||TWO_SIDED|95.0|-2.7|9.0|||||Miettinen \& Nurminen Method|||9.0|-2.7|
73919762|NCT01986855|147367543|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-1.3|||||TWO_SIDED|95.0|-6.5|3.7|||||Miettinen \& Nurminen Method|||3.7|-6.5|
73919763|NCT01986855|147367544|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.03||||0.828|TWO_SIDED|95.0|-0.28|0.23||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.23|-0.28|0.828
73919764|NCT01986855|147367544|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.09||||0.496|TWO_SIDED|95.0|-0.35|0.17||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.17|-0.35|0.496
73919765|NCT01986855|147367545|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.77|||<|0.001|TWO_SIDED|95.0|-2.57|-0.96||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-0.96|-2.57|<0.001
73919766|NCT01986855|147367545|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.84|||<|0.001|TWO_SIDED|95.0|-2.66|-1.02||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-1.02|-2.66|<0.001
73919767|NCT01986855|147367546|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.42||||0.451|TWO_SIDED|95.0|-5.13|2.29||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||2.29|-5.13|0.451
73919768|NCT01986855|147367546|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.46||||0.072|TWO_SIDED|95.0|-7.24|0.31||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.31|-7.24|0.072
73919769|NCT01986855|147367547|SUPERIORITY_OR_OTHER||Difference in the least squares means|-6.81||||0.291|TWO_SIDED|96.0|-19.47|5.85||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||5.85|-19.47|0.291
73919770|NCT01986855|147367547|SUPERIORITY_OR_OTHER||Difference in the least squares means|-15.51||||0.019|TWO_SIDED|95.0|-28.5|-2.53||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-2.53|-28.50|0.019
73919771|NCT01986855|147367548|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.16||||0.713|TWO_SIDED|95.0|0.53|2.56||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model|||||2.56|0.53|0.713
73919772|NCT01986855|147367548|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.06||||0.89|TWO_SIDED|95.0|0.44|2.55||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model|||||2.55|0.44|0.890
73919773|NCT02771990|147367557|OTHER|Pilot study|z-score|3.11||||0.002|TWO_SIDED||||||Regression, Linear|||||||0.002
73919774|NCT02771990|147367558|OTHER|Pilot study||||||0.67|||||||Regression, Linear|||||||0.67
73919775|NCT00848081|147367559|SUPERIORITY_OR_OTHER|||||||0.403||||||1-sided test|Fisher Exact|||The p-value is from a one-sided Fisher's exact test with a significance level of 0.05. A total of 142 subjects per treatment arm would provide 91% power to detect the difference between a Group 1 proportion of 0.03 and a Group 2 proportion of 0.13.||||0.403
73919776|NCT00848081|147367561|SUPERIORITY_OR_OTHER|||||||0.13||||||p-value is on change from baseline|ANCOVA|||The LS mean, standard error, 2-sided 95% confidence interval and p-value for the difference between placebo and tadalafil 5 mg are from an analysis of covariance (ANCOVA) model.||||0.130
73919777|NCT00848081|147367562|SUPERIORITY_OR_OTHER|||||||0.258||||||p-value is on change from baseline|ANOVA|The p-value is from Type III sums of squares ANOVA on rank-transformed data.||||||0.258
73919778|NCT00848081|147367563|SUPERIORITY_OR_OTHER|||||||0.828|||||||ANOVA|P-value is from Type III sums of squares ANOVA on rank-transformed data; p-value is on change from baseline.||||||0.828
73919779|NCT02014597|147367565|OTHER|||||||0.0583||||||Scotopic logCS|Kruskal-Wallis|||||||0.0583
73919780|NCT02014597|147367565|OTHER|||||||0.1762||||||Photopic logCS|Kruskal-Wallis|||||||0.1762
73919781|NCT02014597|147367566|OTHER|||||||0.183||||||Scotopic|Pearson correlation|||Correlation between logCS and MD.||||0.183
73919782|NCT02014597|147367566|OTHER|||||||0.771||||||Photopic|Pearson correlation|||Correlation between logCS and MD.||||0.771
73919783|NCT02014597|147367566|OTHER|||||||0.492||||||Scotopic|Pearson correlation|||Correlation between logCS and PSD.||||0.492
73919784|NCT02014597|147367566|OTHER|||||||0.83||||||Photopic|Pearson correlation|||Correlation between logCS and PSD.||||0.830
73919785|NCT00754624|147367573|SUPERIORITY_OR_OTHER||Slope|-0.048|||||TWO_SIDED|95.0|-0.059|-0.037|||Random coefficient|Adjusted for Baseline FEV1 value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FEV1 data to estimate the annual rate of decline. The model included terms for baseline FEV1 and time (in years) of FEV1 measurements. Missing pulmonary functions were not imputed.||-0.037|-0.059|
73919786|NCT00754624|147367574|SUPERIORITY_OR_OTHER||Slope|-0.058|||||TWO_SIDED|95.0|-0.072|-0.043|||Random Coefficient|Adjusted for Baseline FVC value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FVC data to estimate the annual rate of decline. The model included terms for baseline FVC and time (in years) of FVC measurements. Missing pulmonary functions were not imputed.||-0.043|-0.072|
73919787|NCT00754624|147367575|SUPERIORITY_OR_OTHER||Slope|-0.311|||||TWO_SIDED|95.0|-0.454|-0.168|||Random Coefficient|Adjusted for Baseline DLCo value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed DLco data to estimate the annual rate of decline. The model included terms for baseline DLco and time (in years) of DLco measurements. Missing pulmonary functions were not imputed.||-0.168|-0.454|
73919788|NCT00715078|147367582|NON_INFERIORITY_OR_EQUIVALENCE|Cohort B is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval (CI) for the ratio of Cohort B vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is \>0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of \<20% in upregulation ratios may not be clinically significant.|ratio of geometric means (GeoMean)|1.046||||0.5019|TWO_SIDED|90.0|0.936|1.168|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).||1.168|0.936|0.5019
73919789|NCT00715078|147367582|NON_INFERIORITY_OR_EQUIVALENCE|Cohort C is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval for the ratio of Cohort C vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is \>0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of \<20% in upregulation ratios may not be clinically significant.|the ratio of geometric means|0.907||||0.1443|TWO_SIDED|90.0|0.813|1.013|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).||1.013|0.813|0.1443
73919790|NCT02618434|147367585|SUPERIORITY||Median Difference (Net)|-0.56||||0.9383|TWO_SIDED|95.0|-8.96|7.84|||Wilcoxon (Mann-Whitney)|||||7.84|-8.96|0.9383
73919791|NCT02618434|147367586|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.0979|TWO_SIDED|95.0|-0.33|0.03|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.03|-0.33|0.0979
73919792|NCT02618434|147367586|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.126||0.0502|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.00|-0.50|0.0502
73919793|NCT02618434|147367586|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.141||0.4769|TWO_SIDED|95.0|-0.38|0.18|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.18|-0.38|0.4769
73919794|NCT02618434|147367587|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.113||0.0881|TWO_SIDED|95.0|-0.41|0.03|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.03|-0.41|0.0881
73919795|NCT02618434|147367587|SUPERIORITY||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.135||0.0522|TWO_SIDED|95.0|-0.53|0.0|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.00|-0.53|0.0522
73919796|NCT02618434|147367587|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.156||0.1766|TWO_SIDED|95.0|-0.52|0.1|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.10|-0.52|0.1766
73919797|NCT02618434|147367588|SUPERIORITY||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|1.613||0.3409|TWO_SIDED|95.0|-1.64|4.72|||ANCOVA|||This analysis pertains to the Physical Functioning Summary Score at Visit 6.||4.72|-1.64|0.3409
73919798|NCT02618434|147367588|SUPERIORITY||Mean Difference (Net)|-2.21|STANDARD_ERROR_OF_MEAN|0.952||0.0215|TWO_SIDED|95.0|-4.08|-0.33|||ANCOVA|||This analysis pertains to the Psychosocial Health Summary Score at Visit 6.||-0.33|-4.08|0.0215
73919799|NCT02618434|147367589|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|2.0||0.5977|TWO_SIDED|95.0|-5.0|2.89|||ANCOVA|||This analysis pertains to the Total Score at Visit 6.||2.89|-5.00|0.5977
74027944|NCT02747043|147609534|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-10.9|14.0||||||Percentage risk difference in 'Serious infections'||14.0|-10.9|
74027945|NCT02747043|147609534|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-11.7|13.2||||||Percentage risk difference in 'Severe mucocutaneous reactions'||13.2|-11.7|
73919800|NCT02618434|147367589|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.807||0.8049|TWO_SIDED|95.0|-1.39|1.79|||ANCOVA|||This analysis pertains to the Parental Distress Domain score at Visit 6.||1.79|-1.39|0.8049
73919801|NCT02618434|147367589|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.801||0.8911|TWO_SIDED|95.0|-1.47|1.69|||ANCOVA|||This analysis pertains to the Parent-Child Dysfunctional Interaction score at Visit 6.||1.69|-1.47|0.8911
73919802|NCT02618434|147367589|SUPERIORITY||Mean Difference (Net)|-1.25|STANDARD_ERROR_OF_MEAN|0.849||0.1426|TWO_SIDED|95.0|-2.93|0.42|||ANCOVA|||This analysis pertains to the Difficult Child Domain score Visit 6.||0.42|-2.93|0.1426
73919803|NCT02618434|147367590|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.134||0.6171|TWO_SIDED|95.0|-0.33|0.2|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.20|-0.33|0.6171
73919804|NCT02618434|147367590|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.143||0.0617|TWO_SIDED|95.0|-0.55|0.01|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.01|-0.55|0.0617
73919805|NCT02618434|147367590|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.171||0.4419|TWO_SIDED|95.0|-0.47|0.21|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.21|-0.47|0.4419
73919806|NCT02618434|147367591|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0416|TWO_SIDED|95.0|-0.32|-0.01|||ANCOVA|||This analysis pertains to the Inattention subscale at Visit 6.||-0.01|-0.32|0.0416
73919807|NCT02618434|147367591|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.089||0.0921|TWO_SIDED|95.0|-0.33|0.02|||ANCOVA|||This analysis pertains to Hyperactivity/Impulsivity subscale at Visit 6||0.02|-0.33|0.0921
73919808|NCT02618434|147367591|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.094||0.448|TWO_SIDED|95.0|-0.26|0.11|||ANCOVA|||This analysis pertains to the Oppositional Defiant Disorder subscale at Visit 6||0.11|-0.26|0.4480
73919809|NCT02618434|147367591|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.077||0.0457|TWO_SIDED|95.0|-0.31|0.0|||ANCOVA|||This analysis pertains to the Combined Scale score at Visit 6||-0.00|-0.31|0.0457
73919810|NCT02618434|147367592|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8525|TWO_SIDED|95.0|0.58|1.93|||Regression, Logistic|||This analysis pertains to ≥ 30% Responders.||1.93|0.58|0.8525
74027946|NCT01720667|147609571|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Comparison of 24 hour seizure termination rates using a Fisher's exact test.||||<0.001
73919811|NCT02618434|147367592|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6635|TWO_SIDED|95.0|0.52|1.51|||Regression, Logistic|||This analysis pertains to ≥ 50% Responders.||1.51|0.52|0.6635
73919812|NCT00982592|147367605|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.874|TWO_SIDED|95.0|0.7|1.54|||Log Rank|||||1.54|0.70|0.874
73919813|NCT00982592|147367607|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.253|TWO_SIDED|95.0|0.83|2.05|||Log Rank|||||2.05|0.83|0.253
73919814|NCT00333866|147367614|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-0.23||||0.2361|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using Analysis of Covariance (ANCOVA) with treatment and center in the model, and the baseline mean pain score as covariate.||0.15|-0.61|0.2361
73919815|NCT00333866|147367614|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.0132|TWO_SIDED|95.0|-0.94|-0.17|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.||-0.17|-0.94|0.0132
74027947|NCT01720667|147609572|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Comparison of seizure cessation at 48 hours using Fisher's exact test||||<0.001
74027948|NCT03472534|147609581|OTHER|The p-value for the overall F-test was used to determine if the mean irritation scores were equal for all four products.|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74027949|NCT01221233|147609626|SUPERIORITY||Median Difference (Final Values)|17.6||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.000
73919816|NCT00333866|147367614|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-0.33||||0.1694|TWO_SIDED|95.0|-0.72|0.05|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.||0.05|-0.72|0.1694
73919817|NCT00333866|147367615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0227||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0227
73919818|NCT00333866|147367615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0017
73919819|NCT00333866|147367615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0768||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0768
73919820|NCT00333866|147367616|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.01|||<|0.0001|TWO_SIDED|95.0|-1.42|-0.6|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.60|-1.42|<.0001
73919821|NCT00333866|147367616|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.78||||0.0002|TWO_SIDED|95.0|-1.2|-0.37|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.37|-1.20|0.0002
73919822|NCT00333866|147367616|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48||||0.0222|TWO_SIDED|95.0|-0.89|-0.07|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.07|-0.89|0.0222
73919823|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
74027950|NCT03865407|147609632|SUPERIORITY|||||||0.1839|||||||t-test, 2 sided|||||||0.1839
73919824|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7||||0.0003|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.1|0.0003
73919825|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
73919826|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.3|<.0001
73919827|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
73919828|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
73967097|NCT02596126|147471251|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.7|||<|0.025|TWO_SIDED|95.0|0.39|1.26|||Regression, Cox|||||1.26|0.39|< 0.025
73967098|NCT02596126|147471251|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
73967099|NCT02596126|147471252|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.96|||<|0.025|TWO_SIDED|95.0|0.57|1.63|||Regression, Cox|||||1.63|0.57|< 0.025
73967100|NCT02596126|147471252|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
73967101|NCT02596126|147471253|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|3.09|||<|0.05|TWO_SIDED|95.0|1.38|4.79|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||4.79|1.38|< 0.05
73967102|NCT02596126|147471254|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|-5.19|||<|0.05|TWO_SIDED|95.0|-12.73|2.35|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||2.35|-12.73|< 0.05
73919829|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.5|<.0001
73919830|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
73919831|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67||||0.0005|TWO_SIDED|95.0|-1.0|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.0|0.0005
73967103|NCT02596126|147471255|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|7.09|||<|0.05|TWO_SIDED|95.0|5.57|8.62|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.62|5.57|< 0.05
74027951|NCT03865407|147609633|SUPERIORITY|||||||0.3036|||||||t-test, 2 sided|||||||0.3036
74027952|NCT03865407|147609634|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
73919832|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.28|||<|0.0001||95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
73919833|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.3|<.0001
73919834|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
73919835|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.17|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
73919836|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
73919837|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
73919838|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
73919839|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
73919840|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72||||0.0003|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.1|0.0003
73919841|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
73967104|NCT02596126|147471256|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|3.79|||<|0.05|TWO_SIDED|95.0|2.04|5.55|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||5.55|2.04|< 0.05
73967105|NCT02596126|147471257|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|5.26|||<|0.05|TWO_SIDED|95.0|3.59|6.94|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||6.94|3.59|< 0.05
74027953|NCT03865407|147609635|SUPERIORITY|||||||0.1421|||||||t-test, 2 sided|||||||0.1421
74027954|NCT03865407|147609636|SUPERIORITY|||||||0.0022|||||||t-test, 2 sided|||||||0.0022
73919842|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
73919843|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.0037|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0037
74027955|NCT03865407|147609637|SUPERIORITY|||||||0.3032|||||||t-test, 2 sided|||||||0.3032
74027956|NCT01678846|147609718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.26|0.64|||Regression, Logistic||An odds ratio of less than 1 would demonstrate a protective effect of the intervention. Unadjusted odds ratio presented, accounting for correlation between students within schools.|Does the Toolkit intervention reduce physical violence from school staff to Ugandan primary school students.||0.64|0.26|<0.0001
73919844|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.27|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
73919845|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.4|<.0001
73919846|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0031|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0031
73919847|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.7|-1.5|<.0001
73919848|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
73919849|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53||||0.0117|TWO_SIDED|95.0|-0.9|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.1|-0.9|0.0117
73919850|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
73919851|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
73919852|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.004|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0040
73919853|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.7|-1.6|<.0001
73919854|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
73919855|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.01|TWO_SIDED|95.0|-1.0|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.1|-1.0|0.0100
73919856|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.5|<.0001
73919857|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73||||0.0006|TWO_SIDED|95.0|-1.2|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.2|0.0006
73967106|NCT02596126|147471258|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|4.55|||<|0.05|TWO_SIDED|95.0|-4.35|13.46|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||13.46|-4.35|< 0.05
74027957|NCT02285010|147609740|NON_INFERIORITY|Definition: 50% reduction of morphine consumption Type I error (alpha) 0.05, Type II error (beta) 80%||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
74027958|NCT02285010|147609741|NON_INFERIORITY|Alpha 0.05, Beta 80%||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.10
74027959|NCT02285010|147609742|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.33|||||||Wilcoxon (Mann-Whitney)|||for NRS at rest||||0.33
74027960|NCT02285010|147609742|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.75|||||||Wilcoxon (Mann-Whitney)|||for NRS at movement||||0.75
74027961|NCT02285010|147609743|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.16|||||||Chi-squared|||For pruritus||||0.16
73919858|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4||||0.069|TWO_SIDED|95.0|-0.8|0.0|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||0.0|-0.8|0.0690
73919859|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
73919860|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
73919861|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0054|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0054
73919862|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
73919863|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.3|<.0001
73919864|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.65||||0.0036|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.1|0.0036
73919865|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.16|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.5|<.0001
73919866|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.1|<.0001
73919867|NCT00333866|147367617|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.4|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.0|<.0001
73919868|NCT00333866|147367618|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.537|TWO_SIDED|95.0|0.71|1.95|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||1.95|0.71|0.5370
73919869|NCT00333866|147367618|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.92||||0.0109|TWO_SIDED|95.0|1.16|3.18|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||3.18|1.16|0.0109
73919870|NCT00333866|147367618|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.9613|TWO_SIDED|95.0|0.61|1.68|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||1.68|0.61|0.9613
73919871|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.71|||<|0.0001|TWO_SIDED|95.0|-17.56|-7.86|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-7.86|-17.56|<.0001
73919872|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.28|||<|0.0001|TWO_SIDED|95.0|-18.18|-8.38|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-8.38|-18.18|<.0001
73919873|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.2||||0.0038|TWO_SIDED|95.0|-12.06|-2.33|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.33|-12.06|0.0038
73919874|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.9||||0.0142|TWO_SIDED|95.0|1.19|10.61|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||10.61|1.19|0.0142
73967107|NCT02596126|147471259|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|7.11|||<|0.05|TWO_SIDED|95.0|5.55|8.67|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.67|5.55|< 0.05
73919875|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.92||||0.0414|TWO_SIDED|95.0|0.19|9.66|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.66|0.19|0.0414
73919876|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.21||||0.6165|TWO_SIDED|95.0|-3.53|5.95|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.95|-3.53|0.6165
73919877|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.24||||0.0005|TWO_SIDED|95.0|-14.44|-4.05|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-4.05|-14.44|0.0005
73919878|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.92|||<|0.0001||95.0|-17.17|-6.68|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-6.68|-17.17|<.0001
73919879|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.95||||0.0008|TWO_SIDED|95.0|-14.16|-3.74|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-3.74|-14.16|0.0008
73919880|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.36||||0.0127|TWO_SIDED|95.0|0.08|0.64|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.64|0.08|0.0127
73919881|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.0005|TWO_SIDED|95.0|0.22|0.79|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.79|0.22|0.0005
73919882|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21||||0.1453|TWO_SIDED|95.0|-0.07|0.49|||ANCOVA|||Quality of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.49|-0.07|0.1453
73919883|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.34||||0.1033|TWO_SIDED|95.0|-0.88|9.57|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.57|-0.88|0.1033
73919884|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.14||||0.0007|TWO_SIDED|95.0|3.88|14.41|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||14.41|3.88|0.0007
73919885|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.56||||0.337|TWO_SIDED|95.0|-2.68|7.81|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.81|-2.68|0.3370
73919886|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.01||||0.3308|TWO_SIDED|95.0|-2.05|6.07|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.07|-2.05|0.3308
73919887|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7||||0.7364|TWO_SIDED|95.0|-3.39|4.8|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.80|-3.39|0.7364
73919888|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.76||||0.7132|TWO_SIDED|95.0|-3.31|4.84|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.84|-3.31|0.7132
73967108|NCT02596126|147471260|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|6.6|||<|0.05|TWO_SIDED|95.0|4.93|8.27|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.27|4.93|< 0.05
73919889|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.9||||0.0002|TWO_SIDED|95.0|-10.54|-3.25|||ANCOVA|||Overall sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-3.25|-10.54|0.0002
73919890|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.25|||<|0.0001|TWO_SIDED|95.0|-11.94|-4.55|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-4.55|-11.94|<.0001
73919891|NCT00333866|147367619|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.36||||0.0197|TWO_SIDED|95.0|-8.02|-0.7|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.70|-8.02|0.0197
73919892|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17||||0.3627|TWO_SIDED|95.0|-0.54|0.2|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.20|-0.54|0.3627
73967109|NCT02596126|147471261|SUPERIORITY|Time to first event will be investigated using Cox proportional hazards regression. Hazard ratios and 95% confidence intervals will be obtained from the Cox proportional hazards model. P-values will be obtained using the log-rank test.|Hazard Ratio (HR)|1.42|||<|0.05|TWO_SIDED|95.0|0.97|2.07|||Log Rank|||Statistical analysis title - Non-cardiovascular death||2.07|0.97|< 0.05
73919893|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26||||0.1686|TWO_SIDED|95.0|-0.63|0.11|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.11|-0.63|0.1686
73919894|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18||||0.3468|TWO_SIDED|95.0|-0.55|0.19|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.19|-0.55|0.3468
73919895|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11||||0.7147|TWO_SIDED|95.0|-0.71|0.49|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.49|-0.71|0.7147
73919896|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.63||||0.0409|TWO_SIDED|95.0|-1.23|-0.03|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.03|-1.23|0.0409
73967110|NCT00812461|147471277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.68||0.012|TWO_SIDED|95.0|-3.07|-0.38|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-0.38|-3.07|0.012
73967111|NCT00812461|147471278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.95|STANDARD_ERROR_OF_MEAN|2.89||0.088|TWO_SIDED|95.0|-10.63|0.73|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||0.73|-10.63|0.088
73967112|NCT00812461|147471279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.63|TWO_SIDED|95.0|0.67|1.27|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.27|0.67|0.630
73967113|NCT00812461|147471280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.029|TWO_SIDED|95.0|-0.44|-0.02|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.02|-0.44|0.029
73967114|NCT00812461|147471281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.11||0.111|TWO_SIDED|95.0|-0.38|0.04|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||0.04|-0.38|0.111
74027962|NCT02285010|147609743|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.66|||||||Chi-squared|||For Nausea||||0.66
74027963|NCT02285010|147609743|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.46|||||||Chi-squared|||For Vomiting||||0.46
74027964|NCT02285010|147609743|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.54|||||||Chi-squared|||For Dizziness||||0.54
74027965|NCT02285010|147609743|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.05|||||||Chi-squared|||For visual disturbance||||0.05
73919897|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04||||0.9077|TWO_SIDED|95.0|-0.56|0.63|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.63|-0.56|0.9077
73919898|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5923|TWO_SIDED|95.0|-0.64|0.37|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.37|-0.64|0.5923
74027966|NCT02285010|147609744|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.05||||||P-Value 0.05 was calculated.|Chi-squared|||||||0.05
73919899|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0174|TWO_SIDED|95.0|-1.12|-0.11|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.11|-1.12|0.0174
74027967|NCT01065428|147609746|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
74027968|NCT01065428|147609747|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
74027969|NCT00196937|147609750|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference \[Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group\] was below 10%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.97|2.29||||||Immune response to anti-HPV-16 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.||2.29|-1.97|
73919900|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16||||0.5408|TWO_SIDED|95.0|-0.66|0.35|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.35|-0.66|0.5408
74086651|NCT01011556|147726713|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
73919901|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.7236|TWO_SIDED|95.0|-0.57|0.4|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.40|-0.57|0.7236
73919902|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.71||||0.0045|TWO_SIDED|95.0|-1.19|-0.22|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.22|-1.19|0.0045
73919903|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5613||95.0|-0.63|0.34|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.63|0.5613
73919904|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5609|TWO_SIDED|95.0|-0.6|0.33|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.33|-0.60|0.5609
73919905|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75||||0.0016|TWO_SIDED|95.0|-1.22|-0.28|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.28|-1.22|0.0016
73919906|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21||||0.3692|TWO_SIDED|95.0|-0.68|0.25|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.25|-0.68|0.3692
73919907|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24||||0.3294|TWO_SIDED|95.0|-0.73|0.25|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.25|-0.73|0.3294
73919908|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.027|TWO_SIDED|95.0|-1.05|-0.06|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.06|-1.05|0.0270
73919909|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05||||0.8432|TWO_SIDED|95.0|-0.54|0.44|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.44|-0.54|0.8432
73919910|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46||||0.0806|TWO_SIDED|95.0|-0.98|0.06|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.06|-0.98|0.0806
73919911|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53||||0.047|TWO_SIDED|95.0|-1.06|-0.01|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.01|-1.06|0.0470
73919912|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23||||0.3845|TWO_SIDED|95.0|-0.75|0.29|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.29|-0.75|0.3845
73919913|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12||||0.6326|TWO_SIDED|95.0|-0.37|0.6|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.60|-0.37|0.6326
73919914|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22||||0.374|TWO_SIDED|95.0|-0.71|0.27|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.27|-0.71|0.3740
73919915|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03||||0.8936|TWO_SIDED|95.0|-0.45|0.52|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.52|-0.45|0.8936
74086652|NCT01011556|147726713|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||0.952
74086653|NCT01011556|147726713|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
74086654|NCT01011556|147726713|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.011
74086655|NCT01011556|147726713|SUPERIORITY_OR_OTHER|||||||0.997||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.997
73919916|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19||||0.4743|TWO_SIDED|95.0|-0.73|0.34|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.73|0.4743
74086656|NCT01011556|147726713|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.003
74086657|NCT01011556|147726713|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.112
74086658|NCT01011556|147726713|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.988
74086659|NCT01011556|147726714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
74086660|NCT01011556|147726714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
74086661|NCT01011556|147726714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
73919917|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64||||0.0192|TWO_SIDED|95.0|-1.18|-0.1|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.10|-1.18|0.0192
73919918|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18||||0.5101|TWO_SIDED|95.0|-0.71|0.35|||ANCOVA|||FIQ anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.35|-0.71|0.5101
73919919|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2||||0.4617|TWO_SIDED|95.0|-0.75|0.34|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.75|0.4617
73919920|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97||||0.0006|TWO_SIDED|95.0|-1.51|-0.42|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.42|-1.51|0.0006
73919921|NCT00333866|147367620|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33||||0.229|TWO_SIDED|95.0|-0.88|0.21|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.21|-0.88|0.2290
73919922|NCT00333866|147367621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.44||||0.42|TWO_SIDED|95.0|-4.95|2.06|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||2.06|-4.95|0.4200
73919923|NCT00333866|147367621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.85||||0.0012|TWO_SIDED|95.0|-9.38|-2.31|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.31|-9.38|0.0012
73919924|NCT00333866|147367621|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.17||||0.5126|TWO_SIDED|95.0|-4.68|2.34|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||2.34|-4.68|0.5126
73919925|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51||||0.7781|TWO_SIDED|95.0|-4.07|3.05|||ANCOVA|||Physical functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||3.05|-4.07|0.7781
73919926|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.99||||0.2792|TWO_SIDED|95.0|-1.62|5.59|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.59|-1.62|0.2792
73919927|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.58||||0.7512|TWO_SIDED|95.0|-3.0|4.15|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.15|-3.00|0.7512
73919928|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.02||||0.649|TWO_SIDED|95.0|-3.39|5.43|||ANCOVA|||Physical role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.43|-3.39|0.6490
73919929|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5||||0.5105|TWO_SIDED|95.0|-2.96|5.96|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.96|-2.96|0.5105
73919930|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.39||||0.8625|TWO_SIDED|95.0|-4.04|4.82|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.82|-4.04|0.8625
73919931|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.87||||0.1489|TWO_SIDED|95.0|-1.39|9.12|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.12|-1.39|0.1489
73919932|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.24||||0.0213|TWO_SIDED|95.0|0.93|11.54|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||11.54|0.93|0.0213
73919933|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.75||||0.162|TWO_SIDED|95.0|-1.51|9.02|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.02|-1.51|0.1620
73919934|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.85||||0.2446|TWO_SIDED|95.0|-1.95|7.65|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.65|-1.95|0.2446
73919935|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.01||||0.0429|TWO_SIDED|95.0|0.16|9.85|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.85|0.16|0.0429
73919936|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.35||||0.1721|TWO_SIDED|95.0|-1.46|8.16|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.16|-1.46|0.1721
74086662|NCT03420768|147726847|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.13|17.7||||||||17.70|0.13|
74086663|NCT03420768|147726847|SUPERIORITY||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.26|20.23||||||||20.23|0.26|
73919937|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.08||||0.0291|TWO_SIDED|95.0|0.42|7.74|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.74|0.42|0.0291
73919938|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.93||||0.0017|TWO_SIDED|95.0|2.23|9.62|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.62|2.23|0.0017
74086664|NCT00983476|147726854|SUPERIORITY_OR_OTHER||Slope|2.2||||0.11|TWO_SIDED||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .27 (p=.08); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .29 (p=.06).|Difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time||||0.11
74086665|NCT00983476|147726855|SUPERIORITY_OR_OTHER||Slope|4.02||||0.02|TWO_SIDED||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .40 (p=.02); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .44 (p=.01).|In the obese sample, difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time||||0.02
73919939|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.32||||0.0763|TWO_SIDED|95.0|-0.35|6.99|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.99|-0.35|0.0763
73919940|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.58||||0.1524|TWO_SIDED|95.0|-0.95|6.11|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.11|-0.95|0.1524
73919941|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.36||||0.0032|TWO_SIDED|95.0|1.8|8.93|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.93|1.80|0.0032
73919942|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.82||||0.118|TWO_SIDED|95.0|-0.72|6.36|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.36|-0.72|0.1180
73919943|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.15||||0.1081|TWO_SIDED|95.0|-0.69|6.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.99|-0.69|0.1081
73919944|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.1||||0.0101|TWO_SIDED|95.0|1.22|8.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.99|1.22|0.0101
73919945|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.75||||0.7031|TWO_SIDED|95.0|-3.1|4.6|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.60|-3.10|0.7031
73919946|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.27||||0.4253|TWO_SIDED|95.0|-1.86|4.39|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.39|-1.86|0.4253
73919947|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.73||||0.091|TWO_SIDED|95.0|-0.44|5.89|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.89|-0.44|0.0910
73919948|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.82||||0.2526|TWO_SIDED|95.0|-1.3|4.95|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.95|-1.30|0.2526
73919949|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.62||||0.0195|TWO_SIDED|95.0|0.42|4.82|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.82|0.42|0.0195
73919950|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.66||||0.0013|TWO_SIDED|95.0|1.44|5.88|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.88|1.44|0.0013
74086666|NCT00983476|147726856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14||||0.32|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was not statistically significant.|||||0.32
73919951|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.14||||0.0568|TWO_SIDED|95.0|-0.06|4.34|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.34|-0.06|0.0568
73919952|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13||||0.8529|TWO_SIDED|95.0|-1.54|1.27|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.27|-1.54|0.8529
73919953|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.54||||0.4564|TWO_SIDED|95.0|-0.88|1.96|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.96|-0.88|0.4564
73919954|NCT00333866|147367622|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13||||0.8576|TWO_SIDED|95.0|-1.28|1.54|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.54|-1.28|0.8576
73919955|NCT00333866|147367623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.29||||0.7384|TWO_SIDED|95.0|-1.98|1.4|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.40|-1.98|0.7384
73919956|NCT00333866|147367623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.41||||0.1044|TWO_SIDED|95.0|-3.12|0.29|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.29|-3.12|0.1044
73919957|NCT00333866|147367623|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87||||0.3137|TWO_SIDED|95.0|-2.58|0.83|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.83|-2.58|0.3137
73919958|NCT00333866|147367624|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.09|TWO_SIDED|95.0|-1.28|0.09|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.09|-1.28|0.0900
73967115|NCT00812461|147471282|SUPERIORITY_OR_OTHER||Ratio to placebo|0.96||||0.529|TWO_SIDED|95.0|0.86|1.08|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 224 participants in the placebo group and 207 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||1.08|0.86|0.529
74086667|NCT00983476|147726857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23||||0.11|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.11
73919959|NCT00333866|147367624|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5||||0.1564|TWO_SIDED|95.0|-1.2|0.19|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.19|-1.20|0.1564
73919960|NCT00333866|147367624|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11||||0.7519|TWO_SIDED|95.0|-0.8|0.58|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.58|-0.80|0.7519
73919961|NCT00333866|147367624|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15||||0.6416|TWO_SIDED|95.0|-0.5|0.8|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.80|-0.50|0.6416
73919962|NCT00333866|147367624|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.0778|TWO_SIDED|95.0|-1.25|0.07|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.07|-1.25|0.0778
73919963|NCT00333866|147367624|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21||||0.5191|TWO_SIDED|95.0|-0.87|0.44|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.44|-0.87|0.5191
73919964|NCT00333866|147367625|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.44||||0.534|TWO_SIDED|95.0|-5.97|3.09|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||3.09|-5.97|0.5340
73919965|NCT00333866|147367625|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.44||||0.0014|TWO_SIDED|95.0|-12.0|-2.88|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.88|-12.00|0.0014
74086668|NCT00983476|147726858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75||||0.47|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.47
73919966|NCT00333866|147367625|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56||||0.2694|TWO_SIDED|95.0|-7.09|1.98|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.98|-7.09|0.2694
74086669|NCT00983476|147726859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.51|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.51
74086670|NCT00983476|147726860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.83|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.83
73919967|NCT00333866|147367626|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|263.77||||0.1277|TWO_SIDED|95.0|-75.78|603.33|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using analysis of variance (ANOVA), with treatment and center in the model.||603.33|-75.78|0.1277
74088458|NCT00107042|147730263|SUPERIORITY_OR_OTHER||Responding Rate %|98.11|||||TWO_SIDED|95.0|89.93|99.95||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95% confidence interval||"For overall response, if a subject is reactive at either 1-month or 12-month, then the overall response is considered Positive. If a subject is non-reactive at both 1-month and 12-month, then the overall response for this subject is Negative."|||99.95|89.93|
73919968|NCT00333866|147367626|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|47.89||||0.7829|TWO_SIDED|95.0|-293.2|389.02|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.||389.02|-293.2|0.7829
73919969|NCT00333866|147367626|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.51||||0.9471|TWO_SIDED|95.0|-351.9|328.86|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.||328.86|-351.9|0.9471
73919970|NCT00456547|147367627|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Adjusted for 12 comparisons|t-test, 2 sided|||||||<0.05
73919971|NCT00456547|147367628|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons.|t-test, 2 sided|||||||<0.05
73919972|NCT00456547|147367629|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons|t-test, 2 sided|||||||<0.05
73919973|NCT00456547|147367630|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons|Wilcoxon (Mann-Whitney)|||||||<0.05
73919974|NCT00673465|147367639|SUPERIORITY_OR_OTHER||Difference in least squares mean|-4.4||||0.5269|TWO_SIDED|95.0|-18.5|9.7|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||9.7|-18.5|0.5269
73919975|NCT00673465|147367639|SUPERIORITY_OR_OTHER||Difference in least squares mean|-53.9|||<|0.0001|TWO_SIDED|95.0|-68.1|-39.8|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-39.8|-68.1|<0.0001
73919976|NCT00673465|147367643|SUPERIORITY_OR_OTHER||Difference in least squares mean|-2.81||||0.741|TWO_SIDED|95.0|-20.1|14.5|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||14.5|-20.1|0.7410
73919977|NCT00673465|147367643|SUPERIORITY_OR_OTHER||Difference in least squares mean|-63.6|||<|0.0001|TWO_SIDED|95.0|-80.9|-46.2|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-46.2|-80.9|<0.0001
73919978|NCT00673465|147367645|SUPERIORITY_OR_OTHER||Difference in least squares mean|-3.59||||0.3146|TWO_SIDED|95.0|-10.8|3.6|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||3.6|-10.8|0.3146
73919979|NCT00673465|147367645|SUPERIORITY_OR_OTHER||Difference in least squares mean|-26.6|||<|0.0001|TWO_SIDED|95.0|-33.8|-19.4|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-19.4|-33.8|<0.0001
73967116|NCT00812461|147471283|SUPERIORITY_OR_OTHER||Ratio to placebo|0.92||||0.049|TWO_SIDED|95.0|0.84|1.0|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 222 participants in the placebo group and 205 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||1.00|0.84|0.049
73967117|NCT05529966|147471309|OTHER|||||||0.45490734||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.45490734
73967118|NCT05529966|147471310|OTHER|||||||0.9237611||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.92376110
73967119|NCT05529966|147471311|OTHER|||||||0.94342221||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.94342221
74088459|NCT00107042|147730264|SUPERIORITY_OR_OTHER|||||||0.2938||95.0|||||Fisher Exact|||||||0.2938
74088460|NCT00107042|147730264|SUPERIORITY_OR_OTHER||Responding Rate %|85.37|||||TWO_SIDED|95.0|70.83|94.43|||95 % confidence interval|||||94.43|70.83|
73919980|NCT00533845|147367672|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||t-test, 2 sided|||||||.0022
73919981|NCT01860651|147367677|OTHER||mean difference over time|-0.002||||0.22|TWO_SIDED|95.0|-0.005|0.001|||Mixed Effect Model|||"Statistical analysis of Medical adherence in study Medication adm. at home were analysed using a Mixed Effect Model (MEM). The MEM model included a random patient effect and a fixed effect interaction between group and time, to evaluate difference between the groups over time."||0.001|-0.005|0.22
73919982|NCT01288469|147367683|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.82|||<|0.0001|TWO_SIDED|95.0|-65.62|-46.03||Threshold for significance ≤0.05.|ANCOVA||Alirocumab vs. placebo|Throughout the ANCOVA model, the Alirocumab + atorvastatin 80 mg group was compared to the placebo + atorvastatin 80 mg group using appropriate contrast and the 95% confidence interval (CI) of the difference was provided.||-46.03|-65.62|<0.0001
73967120|NCT05529966|147471312|OTHER|||||||0.38902793||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.38902793
73967121|NCT05529966|147471313|OTHER|||||||0.0042494||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of comfort score||||0.00424940
73967122|NCT05529966|147471313|OTHER|||||||0.00223547||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Visibility score||||.00223547
73967123|NCT05529966|147471313|OTHER|||||||1.858e-05||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Image Quality score||||.00001858
73967124|NCT05529966|147471313|OTHER|||||||0.03003194||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Focus score||||.03003194
73919983|NCT00563381|147367690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83|||<|0.0001||95.0|0.77|0.9|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.90|0.77|<0.0001
73919984|NCT00563381|147367691|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.73|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.66|0.82|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium vs. Salmeterol||0.82|0.66|<0.0001
73919985|NCT00563381|147367692|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.0002||95.0|0.85|0.95|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||0.95|0.85|0.0002
73919986|NCT00563381|147367693|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.89|STANDARD_ERROR_OF_MEAN|0.03||0.0017||95.0|0.83|0.96|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.96|0.83|0.0017
73919987|NCT00563381|147367694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||<|0.0001||95.0|0.61|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.85|0.61|<0.0001
73919988|NCT00563381|147367695|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.0005||95.0|0.66|0.89|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||0.89|0.66|0.0005
73919989|NCT00563381|147367696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0242||95.0|0.78|0.98|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.98|0.78|0.0242
73967125|NCT05529966|147471313|OTHER|||||||2.8e-07||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Depth Perception score||||.00000028
73967126|NCT05529966|147471313|OTHER|||||||0.00112148||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Staff Engagement score||||.00112148
74088461|NCT00107042|147730264|SUPERIORITY_OR_OTHER||Responding Rate %|93.62|||||TWO_SIDED|95.0|82.46|98.66|||95% confidence interval|||||98.66|82.46|
74086671|NCT01175473|147726866|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-154.42|||<|0.0001|TWO_SIDED|95.0|-180.3|-128.54||Linear fixed effects model with fixed terms for treatment, study site and GLU-AUC(0:30-4:30h) at baseline as covariate was used (using Statistical Analysis System \[SAS®\] PROC MIXED procedure).|Linear fixed effects model|No alpha adjustment was performed.||To detect a difference of 100 or 150 h\*mg/dL in change from baseline to Day 28 in GLU-AUC(0:30-4:30h) between lixisenatide and liraglutide, 60 patients per group would provide a power of 90% assuming common standard deviation of 170 or 250 h\*mg/dL, respectively, with a 2-sided test at 5% significance level.||-128.54|-180.30|<0.0001
73919990|NCT00563381|147367697|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.0406||95.0|0.82|1.0|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||1.00|0.82|0.0406
73919991|NCT00563381|147367698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.0001||95.0|0.78|0.91|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.91|0.78|<0.0001
73919992|NCT00563381|147367699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||<|0.0001||95.0|0.69|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.85|0.69|<0.0001
73919993|NCT00563381|147367700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||<|0.0001||95.0|0.78|0.92|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.92|0.78|<0.0001
73919994|NCT00563381|147367701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.68|0.86|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.86|0.68|<0.0001
73919995|NCT00563381|147367702|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.82|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.76|0.9|||Poisson regression|Poisson regression correcting for overdispersion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.90|0.76|<0.0001
73919996|NCT00563381|147367703|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.9|STANDARD_ERROR_OF_MEAN|0.03||0.0036||95.0|0.84|0.97|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.97|0.84|0.0036
73919997|NCT00563381|147367704|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.8|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.73|0.88|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.88|0.73|<0.0001
73919998|NCT00563381|147367705|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.6||||0.1035||95.0|-3.53|0.33|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MMRM) (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.33|-3.53|0.1035
73919999|NCT00563381|147367706|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-2.06||||0.0369||95.0|-3.99|-0.12|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MRMM)(fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week).||Tiotropium versus Salmeterol||-0.12|-3.99|0.0369
73920000|NCT00563381|147367707|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-2.07||||0.0362||95.0|-4.0|-0.13|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||-0.13|-4.00|0.0362
73920001|NCT00563381|147367708|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.88||||0.0573||95.0|-3.82|0.06|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.06|-3.82|0.0573
73920002|NCT00563381|147367709|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.1||||0.2641||95.0|-3.04|0.83|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.83|-3.04|0.2641
73920003|NCT00563381|147367710|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.01||||0.3068||95.0|-2.95|0.93|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.93|-2.95|0.3068
73920004|NCT00563381|147367711|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.78||||0.4299||95.0|-2.72|1.16|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.16|-2.72|0.4299
73920005|NCT00563381|147367712|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.48||||0.6277||95.0|-2.42|1.46|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.46|-2.42|0.6277
73920006|NCT00563381|147367713|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.85||||0.3931||95.0|-2.8|1.1|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.10|-2.80|0.3931
73920007|NCT00563381|147367714|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.97||||0.3297||95.0|-2.92|0.98|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.98|-2.92|0.3297
73920008|NCT00563381|147367715|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.3||||0.1904||95.0|-3.25|0.65|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.65|-3.25|0.1904
73967127|NCT05529966|147471313|OTHER|||||||951||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Teaching score||||00000951
73967128|NCT05529966|147471313|OTHER|||||||0.03493564||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of En Face Confidence score||||.03493564
73967129|NCT05529966|147471313|OTHER|||||||0.12895248||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Hydrus Placement Confidence score||||.12895248
73967130|NCT05529966|147471313|OTHER|||||||0.00279611||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Scope Preference score||||.00279611
73920009|NCT00563381|147367716|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.99||||0.3172||95.0|-2.94|0.95|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.95|-2.94|0.3172
73967131|NCT05529966|147471314|OTHER|||||||0.959638658||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Comfort score||||.959638658
73967132|NCT05529966|147471314|OTHER|||||||0.213464715||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Visibility score||||.213464715
73967133|NCT05529966|147471314|OTHER|||||||0.213464715||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Image Quality score||||.213464715
73967134|NCT05529966|147471314|OTHER|||||||0.155899777||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Focus score||||.155899777
73967135|NCT05529966|147471314|OTHER|||||||0.055960023||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Depth Perception score||||.055960023
73967136|NCT05529966|147471314|OTHER|||||||0.000685499||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Staff Engagement score||||.000685499
73967137|NCT05529966|147471314|OTHER|||||||0.004526118||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Teaching score||||.004526118
73967138|NCT05529966|147471314|OTHER|||||||0.299921137||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of En Face Confidence score||||.299921137
73967139|NCT05529966|147471314|OTHER|||||||0.368082084||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Hydrus Placement Confidence score||||.368082084
73967140|NCT05529966|147471314|OTHER|||||||0.015036417||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Scope Preference score||||.015036417
73920010|NCT00563381|147367717|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.67||||0.5017||95.0|-2.62|1.28|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.28|-2.62|0.5017
73920011|NCT00563381|147367718|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.23||||0.2174||95.0|-3.18|0.72|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.72|-3.18|0.2174
73920012|NCT00563381|147367719|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.1||||0.2682||95.0|-3.05|0.85|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.85|-3.05|0.2682
73967141|NCT04222660|147471315|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73967142|NCT04222660|147471316|OTHER||||||<|0.0025|||||||t-test, 2 sided|||||||<0.0025
73967143|NCT04222660|147471317|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73967144|NCT04222660|147471318|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73967145|NCT04222660|147471319|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73967146|NCT04222660|147471320|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73967147|NCT04222660|147471321|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73967148|NCT04222660|147471322|OTHER||||||<|0.0017|||||||t-test, 2 sided|||||||<0.0017
73967149|NCT04222660|147471323|OTHER||||||<|0.0195|||||||t-test, 2 sided|||||||<0.0195
73967150|NCT05902793|147471324|NON_INFERIORITY|the non-inferiority margin is 20%|least square means difference|0.89|||||TWO_SIDED|95.0|-14.3|16.07|||||To establish non-inferiority the lower limit of the least square mean difference had to be \> -20%.|||16.07|-14.30|
73967151|NCT05902793|147471326|SUPERIORITY|||||||0.24|||||||ANCOVA|ANCOVA model had fixed effects of treatment arm, center and wound size||||||0.24
73967152|NCT04674358|147471340|SUPERIORITY||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|1.67|4.14||||||||4.14|1.67|
73967153|NCT05418296|147471345|SUPERIORITY||||||<|0.46|||||||t-test, 1 sided|||||||<0.46
73967154|NCT05418296|147471346|SUPERIORITY||||||<|0.00314|||||||t-test, 1 sided|||||||<0.00314
73967155|NCT05418296|147471347|SUPERIORITY||||||<|0.066|||||||t-test, 1 sided|||||||<0.066
73967156|NCT05418296|147471348|SUPERIORITY||||||<|0.085|||||||t-test, 1 sided|||||||<0.0850
73967157|NCT05418296|147471349|SUPERIORITY||||||<|0.0716|||||||t-test, 1 sided|||||||<0.0716
73967158|NCT05374837|147471439|SUPERIORITY||Odds Ratio (OR)|0.9585||||0.145|TWO_SIDED|95.0|0.4276|2.1485||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic||Odds of consuming a minimum acceptable diet in control group at endline.|||2.1485|0.4276|0.145
73967159|NCT05374837|147471439|SUPERIORITY||Odds Ratio (OR)|0.9669||||0.145|TWO_SIDED|95.0|0.43|2.1742||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic||Odds of consuming a minimum acceptable diet in intervention group at endline.|||2.1742|0.43|0.145
73967160|NCT05374837|147471440|SUPERIORITY||Odds Ratio (OR)|0.3084||||0.179|TWO_SIDED|95.0|0.1977|0.481||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic|||||0.481|0.1977|0.179
73967161|NCT05374837|147471440|SUPERIORITY||Odds Ratio (OR)|0.438||||0.179|TWO_SIDED|95.0|0.2983|0.6431||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic|||||0.6431|0.2983|0.179
73967162|NCT05374837|147471446|SUPERIORITY|||||||0.054||||||A priori threshold for statistical significance \<0.05.|Chi-squared|||||||0.054
73967163|NCT05374837|147471447|SUPERIORITY|||||||0.65||||||A priori threshold for statistical significance \<0.05|Chi-squared|||||||0.65
73967164|NCT04299009|147471454|OTHER|multilevel linear models with Epworth sleepiness score scores as the dependent variable; treatment block (BLT vs sBLT) as a fixed effect; treatment sequence as a covariate; and participant intercept as a random effect.|regression coefficient|2.45|||<|0.05|TWO_SIDED|95.0|-0.3|5.19|||Mixed Models Analysis|||||5.19|-0.30|<0.05
73967165|NCT02549339|147471456|SUPERIORITY||Ratio of clearance rates|7.57||||0.001|TWO_SIDED|95.0|2.26|25.31|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|||25.31|2.26|0.001
73920013|NCT00563381|147367720|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.59||||0.552||95.0|-2.55|1.36|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.36|-2.55|0.5520
73920014|NCT00110149|147367721|OTHER|As the study was not able to be completed the simple number of patients per outcome is listed.|||||||||||||||||The trial was to measure the response rate and EFS of patients but the manufacturer of the investigational agent closed and sold the agent to a new company so the trial was not able to be completed.|||
73920015|NCT01911689|147367723|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2\* value between the Control group and AP group.||||<0.01
73920016|NCT01911689|147367724|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2\* value between the edematous AP and necrotizing AP||||0.05
73920017|NCT01911689|147367725|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||Analysis of variance (ANOVA) was used to assess the differences in the T2\* value between the mild, moderate, and severe AP groups according to the MRSI score.||||<0.01
73920018|NCT01911689|147367725|SUPERIORITY_OR_OTHER|||||||0.0111|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value in the mild and moderate AP according to MRSI||||0.0111
73920019|NCT01911689|147367725|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value between the mild and severe AP||||0.002
73920020|NCT01911689|147367725|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value between the moderate and severe AP according to MRSI||||0.071
73920021|NCT01911689|147367726|SUPERIORITY_OR_OTHER|||||||0.629|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.629
73920022|NCT00001723|147367733|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|||||||0.007
73920023|NCT02643082|147367759|SUPERIORITY||LS Mean ratio between treatments|1.75|||<|0.0001|TWO_SIDED|95.0|1.65|1.86|||Mixed Models Analysis|||||1.86|1.65|<0.0001
73920024|NCT02643082|147367760|SUPERIORITY||LS Mean ratio between treatments|0.29|||<|0.0001|TWO_SIDED|95.0|0.26|0.33|||Mixed Models Analysis|||||0.33|0.26|<0.0001
73920025|NCT02643082|147367761|SUPERIORITY||LS Mean ratio between treatments|0.29|||<|0.0001|TWO_SIDED|95.0|0.25|0.33|||Mixed Models Analysis|||||0.33|0.25|<0.0001
73920026|NCT02643082|147367762|SUPERIORITY||LS Mean ratio between treatments|1.79|||<|0.0001|TWO_SIDED|95.0|1.67|1.92|||Mixed Models Analysis|||||1.92|1.67|<0.0001
73920027|NCT02643082|147367763|SUPERIORITY||LS Mean Difference Between Treatments|0.443|||<|0.0001|TWO_SIDED|95.0|0.318|0.569|||Mixed Models Analysis|||||0.569|0.318|<0.0001
73920028|NCT02643082|147367764|SUPERIORITY||LS Mean ratio between treatments|0.87|||<|0.0001|TWO_SIDED|95.0|0.82|0.92|||Mixed Models Analysis|||||0.92|0.82|<0.0001
73920029|NCT01867021|147367765|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain A/H1N1 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.85|||||TWO_SIDED|95.0|1.66|2.06|||ANCOVA|Not applicable(NA)||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H1N1 at day 22||2.06|1.66|
74086672|NCT02013531|147726982|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in the MADRS total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
74086673|NCT02013531|147726983|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 6.||||<0.0001
73920030|NCT01867021|147367765|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain A/H3N2 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.5|||||TWO_SIDED|95.0|1.38|1.64|||ANCOVA|||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H3N2 at day 22||1.64|1.38|
73920031|NCT01867021|147367765|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain B considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.93|1.08|||ANCOVA|||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain B at day 22||1.08|0.93|
73920032|NCT01867021|147367766|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|9.0|||||TWO_SIDED|95.0|5.6|11.5|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H1N1 at day 22||11.5|5.6|
73920033|NCT01867021|147367766|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H3N2 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|13.0|||||TWO_SIDED|95.0|10.1|16.1|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H3N2 at day 22||16.1|10.1|
73920034|NCT01867021|147367766|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain B considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|-1.0|||||TWO_SIDED|95.0|-5.0|2.3|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain B at day 22||2.3|-5|
73920035|NCT01862874|147367779|SUPERIORITY||Vaccine Efficacy|85.9|||<|0.001|TWO_SIDED|95.0|52.7|97.3|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 group versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, then superiority of the V501 group is demonstrated.|97.3|52.7|<0.001
73920036|NCT01862874|147367780|OTHER|Statistical testing of no difference in incidence of maximum temperature ≥37.5°C|Risk Difference (RD)|-1.2||||0.256|TWO_SIDED|95.0|-3.5|0.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||0.9|-3.5|0.256
73920037|NCT01862874|147367781|OTHER|Statistical testing of no difference in incidence of injection-site erythema|Risk Difference (RD)|2.9||||0.251|TWO_SIDED|95.0|-2.1|7.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site erythema||7.9|-2.1|0.251
73967166|NCT02549339|147471457|SUPERIORITY||Ratio of clearance rates|5.9|||<|0.001|TWO_SIDED|95.0|3.3|10.54|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.54|3.30|<0.001
73967167|NCT02549339|147471458|SUPERIORITY||Ratio of clearance rates|5.75|||<|0.001|TWO_SIDED|95.0|3.24|10.2|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.20|3.24|<0.001
73967168|NCT02549339|147471459|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.35||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.35|0.25|<0.001
73967169|NCT03958955|147471470|SUPERIORITY||Attributable risk|-0.14||||0.4531|TWO_SIDED|95.0|-0.37|0.09||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Exact p-value of McNemar's test. Success is defined as having an IGA score of 0 (clear) or 1 (almost clear) at Week 6.|||0.09|-0.37|0.4531
73967170|NCT03958955|147471473|SUPERIORITY||Attributable risk|0.07||||0.5|TWO_SIDED|95.0|-0.02|0.17||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success (i.e. no lesion-specific treatment-related AEs) of delgocitinib compared to vehicle. Exact p-value of McNemar's test.|||0.17|-0.02|0.5000
73920038|NCT01862874|147367781|OTHER|Statistical testing of no difference in incidence of injection-site pain|Risk Difference (RD)|6.4||||0.033|TWO_SIDED|95.0|0.5|12.2|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site pain||12.2|0.5|0.033
73920039|NCT01862874|147367781|OTHER|Statistical testing of no difference in incidence of injection-site swelling|Risk Difference (RD)|6.8||||0.003|TWO_SIDED|95.0|2.3|11.3|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site swelling||11.3|2.3|0.003
73920040|NCT01862874|147367782|OTHER|Statistical testing of no difference in incidence of systemic AEs|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-5.2|3.3|||||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||3.3|-5.2|
73920041|NCT01862874|147367783|OTHER|Statistical testing of no difference in incidence of vaccine-related systemic AEs|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-4.1|0.8|||||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||0.8|-4.1|
73920042|NCT01862874|147367784|SUPERIORITY||Vaccine Efficacy|86.5|||<|0.001|TWO_SIDED|95.0|55.2|97.4|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, superiority of the V501 group is demonstrated.|97.4|55.2|<0.001
73920043|NCT02260921|147367785|SUPERIORITY||Difference in Least Squares (LS) Means|-7.53||||0.0002|TWO_SIDED|95.0|-11.48|-3.58||P-values are obtained by fitting an ANCOVA model with treatment as factor and WOMAC baseline pain score as a covariate.|ANCOVA||LS estimates are obtained by fitting an ANCOVA model with treatment as factor and WOMAC baseline pain score as a covariate.|||-3.58|-11.48|0.0002
73920044|NCT00157950|147367833|SUPERIORITY_OR_OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.6|99.8|||||Exact binomial confidence interval|||99.8|93.6|
74027970|NCT00196937|147609750|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference \[Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group\] was below 10%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.87|2.03||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.||2.03|-1.87|
74027971|NCT03425656|147609769|NON_INFERIORITY|We used a non-inferiority margin of 0.25 for the primary endpoint.|Mean Difference (Net)|-0.03||||0.73|TWO_SIDED|95.0|-0.23|0.16|||Chi-squared|||||0.16|-0.23|0.73
73920045|NCT00157950|147367834|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|100.0|||||TWO_SIDED|95.0|96.8|100.0|||||Exact binomial confidence interval|||100|96.8|
73920046|NCT00157950|147367835|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||TWO_SIDED|95.0|95.2|100.0|||||Exact binomial confidence interval|||100|95.2|
74027972|NCT03425656|147609770|OTHER|||||||0.72|||||||Fisher Exact|||||||0.72
74027973|NCT03425656|147609771|OTHER||Chi-squared|0.42||||0.42|TWO_SIDED||||||Chi-squared|||||||0.42
74027974|NCT03425656|147609772|NON_INFERIORITY|We used a non-inferiority margin of 0.25 for the primary endpoint.||||||0.59|||||||Chi-squared|||||||0.59
74086674|NCT02013531|147726989|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in Mean change from Baseline in HAM-A total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
73920047|NCT00157950|147367836|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||TWO_SIDED|95.0|95.0|100.0|||||Exact binomial confidence interval|||100|95.0|
73920048|NCT01500629|147367849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.156|TWO_SIDED|95.0|-1.9|0.33|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.33|-1.90|0.156
73920049|NCT01500629|147367850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.625|TWO_SIDED|95.0|-1.49|0.92|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.92|-1.49|0.625
73920050|NCT01500629|147367851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.291|TWO_SIDED|95.0|-2.12|0.67|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.67|-2.12|0.291
73920051|NCT01500629|147367852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.899|TWO_SIDED|95.0|-1.21|1.07|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.07|-1.21|0.899
73920052|NCT01500629|147367853|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.701||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.701
73920053|NCT01500629|147367854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.108||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.108
73920054|NCT01500629|147367855|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.253||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.253
73920055|NCT01500629|147367856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.287||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.287
73920056|NCT01500629|147367857|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.409||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.409
73920057|NCT01500629|147367858|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.092||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.092
73920058|NCT01500629|147367859|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.042||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.042
73920059|NCT01500629|147367860|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.307||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.307
73920060|NCT01500629|147367861|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.903||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.903
73920061|NCT01500629|147367862|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.121||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.121
73920062|NCT01500629|147367863|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.689||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.689
73920063|NCT01500629|147367864|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.314||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.314
73920064|NCT01500629|147367865|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8||||0.034||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.034
73920065|NCT01500629|147367866|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.845||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.845
73920066|NCT01500629|147367867|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.619||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.619
73920067|NCT01500629|147367868|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.803||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.803
73920068|NCT01500629|147367869|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3||||0.175||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.175
73920069|NCT01500629|147367870|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.206|||||||Wilcoxon (Mann-Whitney)|The rank sum test was based on period difference for comparison between sequence.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.206
73920070|NCT01500629|147367871|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.072||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.072
74086675|NCT03396874|147727005|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|87.3|||<|1e-07|TWO_SIDED|95.0|81.58|100.0||The exact p-value cannot be entered as it is equal to 2.2e-16.|Exact binomial proportion test|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)||We determined the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence or absence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|81.58|<0.0000001
73920071|NCT01500629|147367872|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.014||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||.0140
73920072|NCT01500629|147367873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.907|TWO_SIDED|95.0|-0.24|0.22|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.22|-0.24|0.907
73967171|NCT03958955|147471474|SUPERIORITY||Attributable risk|-0.14||||0.4531|TWO_SIDED|95.0|-0.37|0.09||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib vs vehicle. Exact p-value of McNemar's test. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.|||0.09|-0.37|0.4531
73967172|NCT03958955|147471475|SUPERIORITY||Attributable risk|0.0||||1|TWO_SIDED|95.0|-0.22|0.22||Exact p-value of McNemar's test.|McNemar||||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Exact p-value of McNemar's test. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.|0.22|-0.22|1.0000
73967173|NCT03958955|147471476|SUPERIORITY|||||||0.5797||||||P-value of the Wilcoxon signed rank test.|Wilcoxon signed rank test|Erythema is scored as 0=absent, 1=pink, faint, 2=red, 3=dark red, purple/violaceous/crusted/haemorrhagic. P-value of the Wilcoxon signed rank test.||||||0.5797
74027975|NCT01863758|147609789|SUPERIORITY_OR_OTHER||Annualized number of bleeding episodes|3.13|||<|0.05|TWO_SIDED|95.0|2.56|3.8|||2-sided, 1-sample Poisson test||The annualized number of bleeding episodes in study GENA-01 was 49.36.|This study was considered as showing efficacy if the annualized number of bleeding episodes (BE) was reduced by 50% compared to the number of BEs observed in study GENA-01 (NCT00989196).||3.80|2.56|<0.05
73920073|NCT01500629|147367874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.666|TWO_SIDED|95.0|-0.28|0.18|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.18|-0.28|0.666
73920074|NCT01500629|147367875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.972|TWO_SIDED|95.0|-0.29|0.28|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.28|-0.29|0.972
73920075|NCT01500629|147367876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.521|TWO_SIDED|95.0|-0.31|0.59|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.59|-0.31|0.521
73920076|NCT01500629|147367877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.376|TWO_SIDED|95.0|-0.15|0.39|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.39|-0.15|0.376
73920077|NCT01500629|147367878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.35|TWO_SIDED|95.0|-0.11|0.3|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.30|-0.11|0.350
73920078|NCT01500629|147367879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.947|TWO_SIDED|95.0|-0.36|0.34|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.34|-0.36|0.947
73920079|NCT01500629|147367880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.651|TWO_SIDED|95.0|-0.3|0.19|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.19|-0.30|0.651
73920080|NCT01500629|147367885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.261|TWO_SIDED|95.0|-1.3|0.38|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.38|-1.30|0.261
73920081|NCT01500629|147367886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.481|TWO_SIDED|95.0|-0.51|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.04|-0.51|0.481
73920082|NCT01500629|147367887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.961|TWO_SIDED|95.0|-0.85|0.89|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.89|-0.85|0.961
73920083|NCT01500629|147367888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.546|TWO_SIDED|95.0|-0.57|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.04|-0.57|0.546
73920084|NCT02902965|147367900|OTHER||median PFS|8.5|||||TWO_SIDED|95.0|6.2|10.8|||||Kaplan-Meier estimates for median PFS and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.|||10.8|6.2|
73920085|NCT02902965|147367901|OTHER||ORR in %|56.8|||||TWO_SIDED|95.0|44.7|68.2|||||Overall response = confirmed sCR + CR + VGPR + PR with corresponding 95% Exact binomial Cl|||68.2|44.7|
74027976|NCT01863758|147609790|SUPERIORITY_OR_OTHER||Annualized number of spontaneous BEs|1.9|||<|0.05|TWO_SIDED|95.0|1.46|2.43|||2-sided, 1-sample Poisson test||The annualized number of spontaneous bleeding episodes in study GENA-01 was 32.23|This study was considered as showing efficacy if the annualized number of spontaneous bleeding episodes (BE) was reduced by 50% compared to the number of spontaneous BEs observed in study GENA-01 (NCT00989196).||2.43|1.46|<0.05
73920086|NCT02902965|147367902|OTHER||PFS rate|6.6|||||TWO_SIDED|95.0|1.6|16.9|||||Kaplan-Meier method used for PFS rate and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.|||16.9|1.6|
73920087|NCT02902965|147367905|OTHER||median TTP|10.6|||||TWO_SIDED|95.0|7.8|12.0|||||KM estimates for median TTP with associated 95% CI|||12|7.8|
73920088|NCT00799487|147367937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|95.0|-34.4|-20.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||-20.2|-34.4|<0.0001
73920089|NCT00799487|147367938|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.0|||<|0.0001|TWO_SIDED|95.0|-35.1|-20.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||-20.8|-35.1|<0.0001
73920090|NCT00799487|147367939|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.0|||<|0.0001|TWO_SIDED|95.0|3.4|6.6||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||6.6|3.4|<0.0001
73920091|NCT00799487|147367940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.5|||<|0.0001|TWO_SIDED|95.0|3.2|5.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||5.8|3.2|<0.0001
73920092|NCT00799487|147367941|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|9.5|||<|0.0001|TWO_SIDED|95.0|6.9|12.0||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||12.0|6.9|<0.0001
73920093|NCT00799487|147367942|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.51|||<|0.0001|TWO_SIDED|95.0|-4.27|-2.74||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-2.74|-4.27|<0.0001
73920094|NCT00799487|147367943|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.58|||<|0.0001|TWO_SIDED|95.0|-23.72|-11.45||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-11.45|-23.72|<0.0001
73967174|NCT03958955|147471477|SUPERIORITY|||||||0.7862||||||P-value of the Wilcoxon signed rank test.|Wilcoxon signed rank test|P-value of the Wilcoxon signed rank test.||Total skin disease activity score is the sum of the scores for erythema, scaling/hyperkeratosis, and oedema/infiltration. Total skin disease activity score ranges from 0 to 7 with lower score indicating better state.||||0.7862
73967175|NCT04838262|147471480|OTHER|||||||0.57|||||||Regression, Linear|||||||0.57
73967176|NCT04838262|147471480|OTHER|||||||0.85|||||||Regression, Linear|||||||0.85
73920095|NCT00799487|147367944|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.33|||<|0.0001|TWO_SIDED|95.0|-39.29|-21.37||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-21.37|-39.29|<0.0001
73920096|NCT00799487|147367945|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13||||0.0297|TWO_SIDED|95.0|-2.15|-0.12||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.12|-2.15|0.0297
74027977|NCT01507246|147609862|SUPERIORITY_OR_OTHER||Ratio of geometric means|2.62||||0.0251|TWO_SIDED|95.0|1.14|6.03|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis: Mean ratio of geometric least-squares mean for each group is identical.||6.03|1.14|0.0251
74027978|NCT01507246|147609863|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.24||||0.02767|TWO_SIDED|95.0|1.03|1.49|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis = distribution of costs is identical between the two groups.||1.49|1.03|0.02767
74027979|NCT00969618|147609883|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for total ADHD symptoms score.|Paired t-test|||||||<0.001
74027980|NCT00969618|147609883|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for inattention subscale score.|Paired t-test|||||||<0.001
73920097|NCT00799487|147367946|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84||||0.0955|TWO_SIDED|95.0|-1.84|0.15||P-values were determined by using a general linear mixed model. Finger Windows Forwards was the first non-significant p-value in the gatekeeper sequence.|Mixed Models Analysis|Testing of additional endpoints in the sequence was still performed without any unqualified statements about the individual statistical significance.|Placebo minus Concerta|||0.15|-1.84|0.0955
73920098|NCT00799487|147367947|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.37||||0.0002|TWO_SIDED|95.0|-21.52|-7.23||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-7.23|-21.52|0.0002
73920099|NCT00799487|147367948|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26||||0.2335|TWO_SIDED|95.0|-0.7|0.17||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.17|-0.70|0.2335
73967177|NCT02384317|147471485|SUPERIORITY||Slope|-2.4|STANDARD_DEVIATION|141.77||0.965|TWO_SIDED|95.0|-133.6|128.7|||Random coefficients regression|||||128.7|-133.6|0.965
73967178|NCT04382898|147471518|SUPERIORITY|||||||0.1041|||||||Fisher Exact|||||||0.1041
73967179|NCT04382898|147471524|SUPERIORITY|||||||0.0541|||||||Binomial test|||||||0.0541
73967180|NCT03932682|147471525|OTHER|The primary objective would be achieved if efficacy was demonstrated for at least one of the two primary efficacy endpoints, that is, if the interim analysis-adjusted lower limit of the two-sided confidence interval (CI) for absolute vaccine efficacy (aVE) of QIVc versus the comparator vaccine was greater than 0%.|Cox Proportional Hazard|41.26|||||TWO_SIDED|97.98|21.55|56.02||||||||56.02|21.55|
74027981|NCT00969618|147609883|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for hyperactivity/impulsivity subscale score.|Paired t-test|||||||<0.001
74027982|NCT00969618|147609883|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for ADHD index subscale score.|Paired t-test|||||||<0.001
74027983|NCT00969618|147609884|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
74027984|NCT00969618|147609885|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is GEC subscale score.|Paired t-test|||||||<0.001
74027985|NCT00969618|147609885|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for behavioral regulation subscale score.|Paired t-test|||||||<0.001
73920100|NCT00799487|147367949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.51||||0.2321|TWO_SIDED|95.0|-6.67|1.65||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||1.65|-6.67|0.2321
73920101|NCT00799487|147367950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.52||||0.0015|TWO_SIDED|95.0|-5.64|-1.4||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-1.40|-5.64|0.0015
73920102|NCT00799487|147367951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.38||||0.0101|TWO_SIDED|95.0|-9.43|-1.33||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-1.33|-9.43|0.0101
73967181|NCT03932682|147471526|OTHER|The primary objective would be achieved if efficacy was demonstrated for at least one of the two primary efficacy endpoints, that is, if the interim analysis-adjusted lower limit of the two-sided CI for aVE of QIVc versus the comparator vaccine was greater than 0%.|Cox Proportional Hazard|46.9|||||TWO_SIDED|97.5|19.19|65.11||||||||65.11|19.19|
73967182|NCT03932682|147471527|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|54.49|||||TWO_SIDED|95.0|22.55|73.26||||||||73.26|22.55|
73920103|NCT00799487|147367952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09||||0.6642|TWO_SIDED|95.0|-0.53|0.34||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.34|-0.53|0.6642
73920104|NCT00799487|147367953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.3||||0.004|TWO_SIDED|95.0|-58.89|-11.71||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-11.71|-58.89|0.0040
73967183|NCT03932682|147471528|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|50.67|||||TWO_SIDED|95.0|32.83|63.77||||||||63.77|32.83|
73967184|NCT03932682|147471529|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|100.0|||||TWO_SIDED|95.0|||||||"The 2-sided 95% confidence interval was calculated with a lower limit of not estimable and an upper limit of 100."|||||
73967185|NCT04936035|147471579|SUPERIORITY||Difference in LS Mean|-16.7|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-21.2|-12.3||MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|The adjusted 95% CI and p-value are based on Dunnett's test.|LS Mean Difference between zilebesiran 300 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.|||-12.3|-21.2|<0.0001
73920105|NCT00799487|147367954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08||||0.0012|TWO_SIDED|95.0|-0.14|-0.03||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.03|-0.14|0.0012
73920106|NCT00799487|147367955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07||||0.0051|TWO_SIDED|95.0|-0.12|-0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.02|-0.12|0.0051
73920107|NCT00799487|147367956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05||||0.1768|TWO_SIDED|95.0|-0.13|0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.02|-0.13|0.1768
73920108|NCT00799487|147367957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02||||0.4245|TWO_SIDED|95.0|-0.09|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.04|-0.09|0.4245
73920109|NCT00799487|147367958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|0.0||||0.9729|TWO_SIDED|95.0|-0.09|0.09||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.09|-0.09|0.9729
73920110|NCT00799487|147367959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04||||0.3486|TWO_SIDED|95.0|-0.12|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.04|-0.12|0.3486
73920111|NCT00799487|147367960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03||||0.1466|TWO_SIDED|95.0|-0.07|0.01||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.01|-0.07|0.1466
73920112|NCT00799487|147367961|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03||||0.1368|TWO_SIDED|95.0|-0.01|0.08||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.08|-0.01|0.1368
73920113|NCT02436889|147368007|SUPERIORITY|||||||0.949|||||||ANCOVA|||||||0.949
73920114|NCT02436889|147368008|SUPERIORITY||Mean Difference (Final Values)|3.11||||0.2415|TWO_SIDED|95.0|-2.09|8.31|||ANCOVA|change from baseline, adjusted for baseline value||||8.31|-2.09|0.2415
73920115|NCT02436889|147368009|SUPERIORITY||Mean Difference (Final Values)|-12.01||||0.0001|TWO_SIDED|95.0|-18.16|-5.87|||ANCOVA|||||-5.87|-18.16|0.0001
73920116|NCT02436889|147368010|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.1956|TWO_SIDED|95.0|-1.59|0.33|||ANCOVA|||||0.33|-1.59|0.1956
73920117|NCT02436889|147368011|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.0168|TWO_SIDED|95.0|0.34|3.4|||ANCOVA|||||3.40|0.34|0.0168
74027986|NCT00969618|147609885|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for metacognition subscale score.|Paired t-test|||||||<0.001
74027987|NCT00969618|147609886|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Paired t-test|||||||0.200
74027988|NCT00969618|147609887|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
74027989|NCT00969618|147609888|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GEC subscale score.|Paired t-test|||||||<0.001
74027990|NCT00969618|147609888|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for behavioral regulation subscale score.|Paired t-test|||||||<0.001
74027991|NCT00969618|147609888|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for metacognition subscale score.|Paired t-test|||||||<0.001
74027992|NCT00969618|147609889|SUPERIORITY_OR_OTHER|||||||0.384||95.0|||||Paired t-test|||||||0.384
73920118|NCT02436889|147368012|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.0101|TWO_SIDED|95.0|0.5|3.71|||ANCOVA|||||3.71|0.50|0.0101
73920119|NCT01084174|147368014|OTHER|||||||0.003|||||||Regression, Linear|Analyzed by linear regression models using generalized estimating equations to account for repeated measures over time with robust standard errors||||||.003
73920120|NCT01084174|147368015|OTHER||||||<|0.001|||||||Regression, Linear|||||||<.001
73920121|NCT01084174|147368016|OTHER||||||<|0.001|||||||Regression, Linear|||||||<.001
73920122|NCT01084174|147368017|OTHER|||||||0.4|||||||Regression, Linear|||||||0.40
73920123|NCT01084174|147368018|OTHER|||||||0.07|||||||Regression, Linear|||||||.07
73920124|NCT01084174|147368019|OTHER|||||||0.007|||||||Regression, Linear|||||||.007
73920125|NCT01034462|147368020|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.095||||0.0051|TWO_SIDED|95.0|-5.256|-0.935|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.935|-5.256|0.0051
73920126|NCT01034462|147368021|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.632||||0.001|TWO_SIDED|95.0|-4.193|-1.07|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-1.070|-4.193|0.0010
73920127|NCT02564042|147368027|OTHER||Proportion difference|54.7|||||TWO_SIDED|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID has been presented|||76.6|25.9|
73967186|NCT04936035|147471579|SUPERIORITY||Difference in LS Mean|-15.7|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-20.8|-10.6||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|The adjusted 95% CI and p-value are based on Dunnett's test.|LS Mean Difference between zilebesiran 600 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.|||-10.6|-20.8|<0.0001
73967187|NCT04936035|147471580|SUPERIORITY||Difference in LS Mean|-12.0|STANDARD_ERROR_OF_MEAN|1.89|<|0.0001|TWO_SIDED|95.0|-15.7|-8.3||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-8.3|-15.7|<0.0001
73920128|NCT02564042|147368027|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD has been presented|||73.2|22.2|
73920129|NCT02564042|147368027|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID has been presented|||60.5|6.3|
73920130|NCT02564042|147368027|OTHER||Proportion difference|30.7|||||TWO_SIDED|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD has been presented|||55.9|1.6|
73920131|NCT02564042|147368028|OTHER||Proportion difference|2.9|||||TWO_SIDED|95.0|-21.0|26.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 1 has been presented|||26.6|-21.0|
73920132|NCT02564042|147368028|OTHER||Proportion difference|6.3||||||95.0|-20.5|32.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented|||32.4|-20.5|
73920133|NCT02564042|147368028|OTHER||Proportion difference|15.2|||||TWO_SIDED|95.0|-9.6|39.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented|||39.1|-9.6|
73920134|NCT02564042|147368028|OTHER||Proportion difference|3.3|||||TWO_SIDED|95.0|-23.6|29.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented|||29.9|-23.6|
73920135|NCT02564042|147368028|OTHER||Proportion difference|3.1|||||TWO_SIDED|95.0|-22.2|28.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented|||28.1|-22.2|
73920136|NCT02564042|147368028|OTHER||Proportion difference|27.6|||||TWO_SIDED|95.0|-0.5|52.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented|||52.4|-0.5|
73920137|NCT02564042|147368028|OTHER||Proportion difference|25.8|||||TWO_SIDED|95.0|-0.4|49.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented|||49.3|-0.4|
73920138|NCT02564042|147368028|OTHER||Proportion difference|9.2|||||TWO_SIDED|95.0|-18.4|35.7|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented|||35.7|-18.4|
73920139|NCT02564042|147368028|OTHER||Proportion difference|6.3|||||TWO_SIDED|95.0|-19.7|31.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented|||31.7|-19.7|
73920140|NCT02564042|147368028|OTHER||Proportion difference|45.0|||||TWO_SIDED|95.0|16.6|68.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented|||68.4|16.6|
73920141|NCT02564042|147368028|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented|||61.3|8.7|
73920142|NCT02564042|147368028|OTHER||Proportion difference|32.0|||||TWO_SIDED|95.0|3.5|57.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented|||57.2|3.5|
73920143|NCT02564042|147368028|OTHER||Proportion difference|34.4|||||TWO_SIDED|95.0|6.3|58.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented|||58.7|6.3|
73920144|NCT02564042|147368028|OTHER||Proportion difference|49.4|||||TWO_SIDED|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented|||72.4|20.1|
73920145|NCT02564042|147368028|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented|||73.2|22.2|
73920146|NCT02564042|147368028|OTHER||Proportion difference|30.4|||||TWO_SIDED|95.0|1.0|56.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented|||56.1|1.0|
73920147|NCT02564042|147368028|OTHER||Proportion difference|41.4|||||TWO_SIDED|95.0|12.7|65.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented|||65.0|12.7|
73920148|NCT02564042|147368028|OTHER||Proportion difference|49.4|||||TWO_SIDED|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented|||72.4|20.1|
73920149|NCT02564042|147368028|OTHER||Proportion difference|60.1|||||TWO_SIDED|95.0|33.2|80.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented|||80.1|33.2|
73920150|NCT02564042|147368028|OTHER||Proportion difference|30.0|||||TWO_SIDED|95.0|0.2|56.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented|||56.5|0.2|
73920151|NCT02564042|147368028|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|14.4|66.5|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented|||66.5|14.4|
73920152|NCT02564042|147368028|OTHER||Proportion difference|52.0|||||TWO_SIDED|95.0|23.2|74.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented|||74.4|23.2|
73920153|NCT02564042|147368028|OTHER||Proportion difference|52.4|||||TWO_SIDED|95.0|24.4|74.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented|||74.0|24.4|
73920154|NCT02564042|147368028|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented|||60.5|6.3|
73920155|NCT02564042|147368028|OTHER||Proportion difference|48.3|||||TWO_SIDED|95.0|19.7|71.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented|||71.1|19.7|
73920156|NCT02564042|147368028|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented|||53.9|-36.9|
73920157|NCT02564042|147368028|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented|||81.6|-6.3|
73920158|NCT02564042|147368037|OTHER||Proportion difference|-3.6|||||TWO_SIDED|95.0|-28.8|21.9|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 1 has been presented|||21.9|-28.8|
73967188|NCT04936035|147471580|SUPERIORITY||Difference in LS Mean|-9.1|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-13.4|-4.8||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-4.8|-13.4|<0.0001
73920159|NCT02564042|147368037|OTHER||Proportion difference|-0.3|||||TWO_SIDED|95.0|-25.4|25.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 1 has been presented|||25.1|-25.4|
73920160|NCT02564042|147368037|OTHER||Proportion difference|9.4|||||TWO_SIDED|95.0|-17.5|35.3|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented|||35.3|-17.5|
73920161|NCT02564042|147368037|OTHER||Proportion difference|9.1|||||TWO_SIDED|95.0|-15.4|33.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented .|||33.3|-15.4|
73920162|NCT02564042|147368037|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-17.1|36.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented .|||36.1|-17.1|
73920163|NCT02564042|147368037|OTHER||Proportion difference|6.3|||||TWO_SIDED|95.0|-19.3|31.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented|||31.0|-19.3|
73920164|NCT02564042|147368037|OTHER||Proportion difference|9.7|||||TWO_SIDED|95.0|-18.2|36.7|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented|||36.7|-18.2|
73920165|NCT02564042|147368037|OTHER||Proportion difference|19.4|||||TWO_SIDED|95.0|-6.9|43.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented .|||43.6|-6.9|
73920166|NCT02564042|147368037|OTHER||Proportion difference|12.7|||||TWO_SIDED|95.0|-15.1|38.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented|||38.9|-15.1|
73920167|NCT02564042|147368037|OTHER||Proportion difference|12.5|||||TWO_SIDED|95.0|-13.6|37.4|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented .|||37.4|-13.6|
73920168|NCT02564042|147368037|OTHER||Proportion difference|42.3|||||TWO_SIDED|95.0|13.8|66.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented|||66.0|13.8|
73920169|NCT02564042|147368037|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented|||61.3|8.7|
73920170|NCT02564042|147368037|OTHER||Proportion difference|33.3|||||TWO_SIDED|95.0|4.8|58.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented .|||58.2|4.8|
73920171|NCT02564042|147368037|OTHER||Proportion difference|40.6|||||TWO_SIDED|95.0|12.8|63.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented.|||63.9|12.8|
73920172|NCT02564042|147368037|OTHER||Proportion difference|54.7|||||TWO_SIDED|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented.|||76.6|25.9|
73920173|NCT02564042|147368037|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented|||73.2|22.2|
73920174|NCT02564042|147368037|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented|||60.5|6.3|
73920175|NCT02564042|147368037|OTHER||Proportion difference|30.7|||||TWO_SIDED|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented|||55.9|1.6|
73920176|NCT02564042|147368037|OTHER||Proportion difference|51.3|||||TWO_SIDED|95.0|22.0|74.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented|||74.0|22.0|
73920177|NCT02564042|147368037|OTHER||Proportion difference|61.5|||||TWO_SIDED|95.0|34.6|81.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented|||81.0|34.6|
73920178|NCT02564042|147368037|OTHER||Proportion difference|23.9|||||TWO_SIDED|95.0|-6.1|51.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented|||51.0|-6.1|
73920179|NCT02564042|147368037|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|7.8|61.6|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented|||61.6|7.8|
73920180|NCT02564042|147368037|OTHER||Proportion difference|53.1|||||TWO_SIDED|95.0|24.7|75.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented|||75.6|24.7|
73920181|NCT02564042|147368037|OTHER||Proportion difference|53.8|||||TWO_SIDED|95.0|25.8|75.5|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented|||75.5|25.8|
73920182|NCT02564042|147368037|OTHER||Proportion difference|29.4|||||TWO_SIDED|95.0|-0.3|55.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented|||55.0|-0.3|
73920183|NCT02564042|147368037|OTHER||Proportion difference|35.7|||||TWO_SIDED|95.0|6.5|60.2|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented|||60.2|6.5|
73920184|NCT02564042|147368037|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented|||53.9|-36.9|
73920185|NCT02564042|147368037|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented|||81.6|-6.3|
73920186|NCT02564042|147368037|OTHER||Proportion difference|25.0|||||TWO_SIDED|95.0|-35.7|80.6|||||Difference between GSK2894512 0.5% BID and Vehicle BID at EW has been presented|||80.6|-35.7|
73920187|NCT02289898|147368072|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.7158|TWO_SIDED|95.0|0.63|1.375|||Wilcoxon (Mann-Whitney)|||Efficacy (investigator-assessed Kaplan-Meier estimates of progression-free survival) of placebo/placebo arm to the pooled demcizumab arm (i.e., placebo/placebo arm to demcizumab/placebo and demcizumab/demcizumab arms) in subjects with first-line metastatic pancreatic ductal adenocarcinoma.||1.375|0.630|=0.7158
73920188|NCT03070782|147368076|SUPERIORITY||Mean Difference in % CFB|-31.0||||0.0032|TWO_SIDED|95.0|-46.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-12|-46|0.0032
73920189|NCT03070782|147368076|SUPERIORITY||Mean Difference in % CFB|-54.0|||<|0.0001|TWO_SIDED|95.0|-64.0|-41.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-41|-64|<.0001
73920190|NCT03070782|147368076|SUPERIORITY||Mean Difference in % CFB|-70.0|||<|0.0001|TWO_SIDED|95.0|-77.0|-62.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-62|-77|<.0001
73920191|NCT03070782|147368076|SUPERIORITY||Mean Difference in % CFB|-56.0|||<|0.0001|TWO_SIDED|95.0|-65.0|-43.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-43|-65|<.0001
73920192|NCT03070782|147368076|SUPERIORITY||Mean Difference in % CFB|-78.0|||<|0.0001|TWO_SIDED|95.0|-83.0|-72.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-72|-83|<.0001
73920193|NCT03070782|147368080|SUPERIORITY||Mean Difference in % CFB|-6.0||||0.4407|TWO_SIDED|95.0|-19.0|9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||9|-19|0.4407
73920194|NCT03070782|147368080|SUPERIORITY||Mean Difference in % CFB|-25.0|||<|0.0001|TWO_SIDED|95.0|-35.0|-13.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-13|-35|<.0001
73920195|NCT03070782|147368080|SUPERIORITY||Mean Difference in % CFB|-14.0||||0.0368|TWO_SIDED|95.0|-26.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-1|-26|0.0368
74086676|NCT03396874|147727006|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|92.3|||<|1e-07|TWO_SIDED|95.0|90.0|100.0||Per patient basis p-value = 2.2e-16|binomial proportion test|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)||PPV, composite standard, per-patient basis: We determined the positive predictive value (PPV) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100|90.0|<0.0000001
74088462|NCT01221090|147730266|SUPERIORITY_OR_OTHER|||||||0.771||95.0||||A priori threshold for statistical significance is \<0.05|Likelihood Ratio Tests|||We used a multilevel statistical model including time (in days) as a continuous variable, where 0=baseline. The lowest level of the hierarchy was repeated measurements of HbA1c on each subject, with participants themselves constituting the 2nd level. Forward selection was utilized, in which powers of time were added one at a time to the base model including treatment group effects. Interaction terms between time \& treatment effects were added gradually and evaluated with likelihood ratio tests.||||0.771
73920196|NCT03070782|147368080|SUPERIORITY||Mean Difference in % CFB|-16.0||||0.0216|TWO_SIDED|95.0|-28.0|-3.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-3|-28|0.0216
73920197|NCT03070782|147368080|SUPERIORITY||Mean Difference in % CFB|-22.0||||0.0012|TWO_SIDED|95.0|-33.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-33|0.0012
73920198|NCT03070782|147368081|SUPERIORITY||Odds Ratio (OR)|4.98||||0.0286|TWO_SIDED|95.0|1.2|21.0|||Regression, Logistic|||||21.0|1.2|0.0286
73920199|NCT03070782|147368081|SUPERIORITY||Odds Ratio (OR)|31.07|||<|0.0001|TWO_SIDED|95.0|7.3|131.4|||Regression, Logistic|||||131.4|7.3|<.0001
73920200|NCT03070782|147368081|SUPERIORITY||Odds Ratio (OR)|122.81|||<|0.0001|TWO_SIDED|95.0|24.0|627.4|||Regression, Logistic|||||627.4|24.0|<.0001
73920201|NCT03070782|147368081|SUPERIORITY||Odds Ratio (OR)|43.78|||<|0.0001|TWO_SIDED|95.0|9.8|195.0|||Regression, Logistic|||||195.0|9.8|<.0001
73920202|NCT03070782|147368081|SUPERIORITY||Odds Ratio (OR)|1124.56|||<|0.0001|TWO_SIDED|95.0|109.3|11571.0|||Regression, Logistic|||||11571|109.3|<.0001
73920203|NCT03070782|147368082|SUPERIORITY||Odds Ratio (OR)|7.34||||0.2007|TWO_SIDED|95.0|0.3|155.3|||Regression, Logistic|||||155.3|0.3|0.2007
73920204|NCT03070782|147368082|SUPERIORITY||Odds Ratio (OR)|27.92||||0.0258|TWO_SIDED|95.0|1.5|521.5|||Regression, Logistic|||||521.5|1.5|0.0258
73920205|NCT03070782|147368082|SUPERIORITY||Odds Ratio (OR)|113.92||||0.0014|TWO_SIDED|95.0|6.2|2098.5|||Regression, Logistic|||||2098.5|6.2|0.0014
73920206|NCT03070782|147368082|SUPERIORITY||Odds Ratio (OR)|59.85||||0.0063|TWO_SIDED|95.0|3.2|1128.0|||Regression, Logistic|||||1128.0|3.2|0.0063
73920207|NCT03070782|147368082|SUPERIORITY||Odds Ratio (OR)|347.02|||<|0.0001|TWO_SIDED|95.0|18.3|6597.9|||Regression, Logistic|||||6597.9|18.3|<.0001
73920208|NCT03070782|147368083|SUPERIORITY||Mean Difference in % CFB|-4.0||||0.4022|TWO_SIDED|95.0|-12.0|5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||5|-12|0.4022
73920209|NCT03070782|147368083|SUPERIORITY||Mean Difference in % CFB|-16.0|||<|0.0001|TWO_SIDED|95.0|-23.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-23|<.0001
73920210|NCT03070782|147368083|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0323|TWO_SIDED|95.0|-17.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-1|-17|0.0323
73920211|NCT03070782|147368083|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.0157|TWO_SIDED|95.0|-18.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-2|-18|0.0157
73967189|NCT04936035|147471581|SUPERIORITY||Difference in LS Mean|-14.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001|TWO_SIDED|95.0|-18.9|-9.4||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-9.4|-18.9|<0.0001
74027993|NCT05136885|147609890|SUPERIORITY||Disease Rate Ratio|0.87|STANDARD_DEVIATION|0.111|||TWO_SIDED|95.0|0.665|1.102||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. (Trehalose) slowed progression) was (0.8772). NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by Trehalose relative to placebo.Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, baseline use of Relyvrio, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, serum NfL concentration and random effects for regimen and participant-specific slopes.|1.102|0.665|
74027994|NCT05136885|147609892|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|1.79||0.7607|TWO_SIDED|95.0|-4.06|2.97|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, pre-baseline ALSFRS-R slope, and baseline log-transformed NfL.|Trehalose 24-week change from baseline relative to placebo 24-week change from baseline.|||2.97|-4.06|0.7607
74086677|NCT03396874|147727006|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|95.29|||<|1e-07|TWO_SIDED|95.0|93.3|100.0||Per patient basis p-value = 2.2e-16|Sensitivity|||Sensitivity, composite standard, per-patient basis: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). On a per-patient basis, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|93.3|<0.0000001
74027995|NCT05136885|147609893|SUPERIORITY||Mean Difference (Net)|0.92|STANDARD_ERROR_OF_MEAN|3.204||0.7737|TWO_SIDED|95.0|-5.37|7.21|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, pre-baseline ALSFRS-R slope, and baseline log-transformed NfL.|Trehalose 24-week change from baseline relative to placebo 24-week change from baseline.|||7.21|-5.37|0.7737
74027996|NCT05136885|147609894|SUPERIORITY|||||||0.2137|||||||Log Rank|||||||0.2137
74027997|NCT01438710|147609913|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|95.0|||||t-test, 2 sided|||The mean change (i.e., absolute change) from baseline (Day 7, pre-conversion) on FTM overall score to Day 14 (post-conversion) was evaluated using paired t-test (at 0.05 significance level, two sided). An estimation of mean change from baseline and the corresponding 95% confidence interval (CI) were provided.||||0.0048
74027998|NCT02773758|147609940|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.509|-1.071|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-1.071|-1.509|<0.0001
74027999|NCT01592851|147609947|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.03|-0.63||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.63|-1.03|<0.0001
74028000|NCT01592851|147609948|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26||||0.0006|TWO_SIDED|95.0|-0.41|-0.12||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.12|-0.41|0.0006
74088463|NCT01221090|147730267|SUPERIORITY_OR_OTHER|||||||0.2176||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimates.||||||0.2176
73967190|NCT04936035|147471581|SUPERIORITY||Difference in LS Mean|-14.2|STANDARD_ERROR_OF_MEAN|2.38|<|0.0001|TWO_SIDED|95.0|-18.9|-9.5||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-9.5|-18.9|<0.0001
74028001|NCT01592851|147609949|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.28||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.28|-0.63|<0.0001
74028002|NCT01592851|147609950|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|19.42|||<|0.0001|TWO_SIDED|95.0|13.7|25.15||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||25.15|13.70|<0.0001
74028003|NCT01592851|147609951|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.84||||0.0021|TWO_SIDED|95.0|2.54|11.13||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||11.13|2.54|0.0021
74088464|NCT01221090|147730268|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||A priori threshold for statistical significance was \<0.05|Fisher Exact|||||||0.572
73920212|NCT03070782|147368083|SUPERIORITY||Mean Difference in % CFB|-17.0|||<|0.0001|TWO_SIDED|95.0|-24.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-24|<.0001
73920213|NCT03070782|147368084|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.4956|TWO_SIDED|95.0|-32.0|21.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||21|-32|0.4956
73920214|NCT03070782|147368084|SUPERIORITY||Mean Difference in % CFB|-36.0||||0.0027|TWO_SIDED|95.0|-52.0|-14.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-14|-52|0.0027
73920215|NCT03070782|147368084|SUPERIORITY||Mean Difference in % CFB|-54.0|||<|0.0001|TWO_SIDED|95.0|-65.0|-38.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-38|-65|<.0001
73920216|NCT03070782|147368084|SUPERIORITY||Mean Difference in % CFB|-31.0||||0.0114|TWO_SIDED|95.0|-48.0|-8.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-8|-48|0.0114
73920217|NCT03070782|147368084|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-49.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-49|-72|<.0001
73920218|NCT03070782|147368085|SUPERIORITY||Mean Difference in % CFB|-45.0||||0.002|TWO_SIDED|95.0|-62.0|-19.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-19|-62|0.0020
73920219|NCT03070782|147368085|SUPERIORITY||Mean Difference in % CFB|-63.0|||<|0.0001|TWO_SIDED|95.0|-74.0|-46.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-46|-74|<.0001
73920220|NCT03070782|147368085|SUPERIORITY||Mean Difference in % CFB|-82.0|||<|0.0001|TWO_SIDED|95.0|-87.0|-73.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-73|-87|<.0001
73920221|NCT03070782|147368085|SUPERIORITY||Mean Difference in % CFB|-68.0|||<|0.0001|TWO_SIDED|95.0|-78.0|-54.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-54|-78|<.0001
73920222|NCT03070782|147368085|SUPERIORITY||Mean Difference in % CFB|-89.0|||<|0.0001|TWO_SIDED|95.0|-93.0|-84.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-84|-93|<.0001
73920223|NCT02746874|147368105|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||.978
73920224|NCT02746874|147368107|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||.978
74088465|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar."||||0.26
73920225|NCT02746874|147368108|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||.371
73920226|NCT02746874|147368109|SUPERIORITY|||||||0.325|||||||t-test, 2 sided|||||||.325
73920227|NCT02746874|147368110|SUPERIORITY|||||||0.466|||||||t-test, 2 sided|||||||.466
73920228|NCT02746874|147368111|SUPERIORITY|||||||0.368|||||||Wilcoxon (Mann-Whitney)|||||||.368
73920229|NCT02746874|147368112|SUPERIORITY|||||||0.509|||||||Wilcoxon (Mann-Whitney)|||||||.509
73920230|NCT02746874|147368113|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||.593
73920231|NCT02746874|147368114|SUPERIORITY|||||||0.687|||||||Wilcoxon (Mann-Whitney)|||||||0.687
73920232|NCT02746874|147368115|SUPERIORITY|||||||0.813|||||||Wilcoxon (Mann-Whitney)|||||||.813
73920233|NCT02746874|147368116|SUPERIORITY|||||||0.687|||||||Wilcoxon (Mann-Whitney)|||||||.687
73920234|NCT02746874|147368117|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.840
73920235|NCT02746874|147368118|SUPERIORITY|||||||0.913|||||||Wilcoxon (Mann-Whitney)|||||||.913
73967191|NCT04936035|147471582|SUPERIORITY||Difference in LS Mean|-12.1|STANDARD_ERROR_OF_MEAN|2.55|<|0.0001|TWO_SIDED|95.0|-17.2|-7.1||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-7.1|-17.2|<0.0001
73920236|NCT02746874|147368119|SUPERIORITY|||||||0.301|||||||Wilcoxon (Mann-Whitney)|||||||0.301
73920237|NCT02746874|147368120|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
73920238|NCT02746874|147368121|SUPERIORITY|||||||0.813|||||||Wilcoxon (Mann-Whitney)|||||||.813
73920239|NCT02746874|147368123|SUPERIORITY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||.047
73920240|NCT02746874|147368124|SUPERIORITY|||||||0.115|||||||Wilcoxon (Mann-Whitney)|||||||.115
73920241|NCT02746874|147368125|SUPERIORITY|||||||0.349|||||||Wilcoxon (Mann-Whitney)|||||||.349
73920242|NCT01454947|147368144|SUPERIORITY|||||||0.007||||||P values computed using difference between proportions (z value) with Bonferroni correction.|2 proportion Z-test|||||||0.007
73920243|NCT02756689|147368150|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
73920244|NCT02756689|147368151|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
73920245|NCT02756689|147368152|SUPERIORITY||Risk Ratio (RR)|2.1||||0.09|TWO_SIDED|95.0|0.8|5.3|||Chi-squared|||||5.3|0.8|0.09
73920246|NCT02756689|147368153|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||0.12
73920247|NCT02756689|147368154|SUPERIORITY||Risk Ratio (RR)|3.3||||0.06|TWO_SIDED|95.0|0.9|11.4|||Chi-squared|||||11.4|0.9|0.06
73920248|NCT02756689|147368155|SUPERIORITY||Risk Ratio (RR)|0.8||||0.74|TWO_SIDED|95.0|0.2|2.8|||Chi-squared|||||2.8|0.2|0.74
73920249|NCT02756689|147368156|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73920250|NCT02756689|147368157|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
73920251|NCT02756689|147368158|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
73920252|NCT02756689|147368159|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
73920253|NCT02756689|147368160|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
73920254|NCT02756689|147368161|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.2|4.7|||Chi-squared|||||4.7|0.2|>0.99
73920255|NCT02756689|147368162|SUPERIORITY||Risk Ratio (RR)|0.7||||0.43|TWO_SIDED|95.0|0.3|1.7|||Chi-squared|||||1.7|0.3|0.43
73967192|NCT04936035|147471582|SUPERIORITY||Difference in LS Mean|-10.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-15.1|-5.3||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-5.3|-15.1|<0.0001
74028004|NCT01592851|147609952|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|3.87||||0.007|TWO_SIDED|95.0|1.08|6.65||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||6.65|1.08|0.0070
74028005|NCT04315363|147609961|EQUIVALENCE|Two by two Mixed Analysis of Variance (ANOVA) models (i.e., within-subject effect: pre- and post- intervention \* between-subject effect: intervention and control group) were estimated to investigate the primary outcome changes (i.e., sedentary time) before and after the intervention.||||||0.8|||||||ANOVA|||||||0.8
74028006|NCT04315363|147609962|EQUIVALENCE|Two by two Mixed Analysis of Variance (ANOVA) models (i.e., within-subject effect: pre- and post- intervention \* between-subject effect: intervention and control group) were estimated to investigate the secondary outcome changes (i.e., moderate-to-vigorous physical activity) before and after the intervention.||||||0.35|||||||ANOVA|||||||0.35
74028007|NCT00283712|147609996|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-0.22|0.22|||Fisher Exact|||The study goals were to gather evidence of safety and possible efficacy of infliximab for treatment of pemphigus vulgaris (PV). The analyses focused on estimation rather than hypothesis testing; therefore, there was not sufficient power to detect plausible treatment differences unless they were very large. The sample size reflects a balance between the desire to meet study goals and to expose as few participants as possible until the safety of infliximab for treatment of PV has been clarified.||0.22|-0.22|1.00
74028008|NCT00283712|147609996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|90.0|0.02|42.67|||Fisher Exact|||||42.67|0.02|1.00
74028009|NCT00283712|147609997|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|90.0|-0.26|0.06||||||||0.06|-0.26|
74028010|NCT00283712|147609998|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||1|TWO_SIDED|90.0|-0.31|0.36||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.||0.36|-0.31|1.00
73967193|NCT04936035|147471583|SUPERIORITY||Odds Ratio (OR)|10.73|||<|0.0001|TWO_SIDED|95.0|3.76|30.64||Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate|Regression, Logistic|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||30.64|3.76|<0.0001
74028011|NCT00283712|147609998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||1|TWO_SIDED|90.0|0.02|38.35||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.||38.35|0.02|1.00
74028012|NCT00283712|147609999|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2||||0.65|TWO_SIDED|90.0|-0.15|0.55|||Fisher Exact|||||0.55|-0.15|0.65
73967194|NCT04936035|147471583|SUPERIORITY||Odds Ratio (OR)|17.93|||<|0.0001|TWO_SIDED|95.0|6.24|51.52||Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate|Regression, Logistic|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||51.52|6.24|<0.0001
74028013|NCT00283712|147609999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.65|TWO_SIDED|90.0|0.06|2.79|||Fisher Exact|||||2.79|0.06|0.650
74028014|NCT00283712|147610009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-0.3|0.3|||Fisher Exact|||||0.3|-0.3|1.00
74028015|NCT01380093|147610051|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.9|||<|0.0001|TWO_SIDED|95.0|-31.7|-18.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||Least square (LS) mean and 95% confidence interval (CI) were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.1|-31.7|<0.0001
74028016|NCT01380093|147610051|SUPERIORITY_OR_OTHER||LS Mean Difference|11.9||||0.0009|TWO_SIDED|95.0|5.1|18.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.6|5.1|0.0009
73920256|NCT02756689|147368163|SUPERIORITY||Risk Ratio (RR)|0.3||||0.09|TWO_SIDED|95.0|0.1|1.3|||Chi-squared|||||1.3|0.1|0.09
73920257|NCT02756689|147368164|SUPERIORITY||Risk Ratio (RR)|0.7||||0.68|TWO_SIDED|95.0|0.1|3.8|||Chi-squared|||||3.8|0.1|0.68
74028017|NCT01380093|147610051|SUPERIORITY_OR_OTHER||LS Mean Difference|36.8|||<|0.0001|TWO_SIDED|95.0|30.0|43.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||43.6|30.0|<0.0001
74088466|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar the recommended times."||||0.21
74088467|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Exercise at least 30 minutes."||||0.53
73920258|NCT02756689|147368165|SUPERIORITY||Risk Ratio (RR)|0.8||||0.73|TWO_SIDED|95.0|0.3|2.6|||Chi-squared|||||2.6|0.3|0.73
73920259|NCT02756689|147368166|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
73920260|NCT02756689|147368167|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.1|15.4|||Chi-squared|||||15.4|0.1|>0.99
73920261|NCT02756689|147368168|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
73920262|NCT02756689|147368169|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
73920263|NCT02756689|147368170|SUPERIORITY||Risk Ratio (RR)|0.3||||0.37|TWO_SIDED|95.0|0.03|2.3|||Chi-squared|||||2.3|0.03|0.37
73967195|NCT03978871|147471615|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||<0.001
73967196|NCT03978871|147471616|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.023|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||0.023
73967197|NCT03978871|147471616|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.034|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.034
73967198|NCT03978871|147471617|SUPERIORITY|The threshold for statistical significance was p = 0.0.5|||||<|0.001|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||<.001
73967199|NCT03978871|147471617|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.002|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.002
73967200|NCT03978871|147471618|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.227|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education). This is a test of between-subjects effect.||||0.227
73967201|NCT03978871|147471619|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.272|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect for accuracy (Growth Mindset vs. Brain Education). This is a test of between-subjects effect.||||0.272
73967202|NCT03978871|147471620|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.217|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation involuntary dysregulation subscale post psycho-educational lesson. This is a test of between-subjects effect.||||0.217
74028018|NCT01380093|147610052|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.7|||<|0.0001|TWO_SIDED|95.0|-20.2|-11.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence. Planned power of at least 89% assumed a mean difference of 15 to 30 points and a standard deviation of paired differences of 15 to 20 points, with conservative multiple comparison adjustment for alpha of 0.025.||-11.1|-20.2|<0.0001
74028019|NCT01380093|147610052|SUPERIORITY_OR_OTHER||LS Mean Difference|13.4|||<|0.0001|TWO_SIDED|95.0|8.9|18.0||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.0|8.9|<0.0001
74086678|NCT03396874|147727006|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|91.1|||<|1e-07|TWO_SIDED|95.0|86.2|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, prostate or prostate bed: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|86.2|<0.0000001
73920264|NCT02756689|147368171|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
73920265|NCT02756689|147368172|SUPERIORITY||Risk Ratio (RR)|0.5||||0.62|TWO_SIDED|95.0|0.05|5.3|||Chi-squared|||||5.3|0.05|0.62
73920266|NCT02756689|147368173|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.3|3.2|||Chi-squared|||||3.2|0.3|>0.99
73920267|NCT02756689|147368174|SUPERIORITY|||||||0.234|||||||Wilcoxon (Mann-Whitney)|||||||0.234
73920268|NCT02756689|147368175|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
73920269|NCT02756689|147368176|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
73920270|NCT02756689|147368177|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
73920271|NCT02756689|147368178|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
73920272|NCT02756689|147368179|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
73920273|NCT02756689|147368180|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
73920274|NCT02756689|147368181|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
73920275|NCT02756689|147368182|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
73967203|NCT03978871|147471620|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.458|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation involuntary dysregulation subscale post psycho-educational lesson. This is a test of between-subjects effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.458
73967204|NCT03978871|147471620|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.037|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation proactive engagement subscale post psycho-educational lesson. This is a test of between-subjects effect.||||0.037
73967205|NCT03978871|147471620|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.107|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation proactive engagement subscale post psycho-educational lesson. This is a test of between-subjects effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.107
73920276|NCT02756689|147368183|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
73920277|NCT02756689|147368184|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
73920278|NCT02756689|147368185|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
73967206|NCT03978871|147471620|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.369|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation cognitive avoidance subscale post psycho-educational lesson. This is a test of between-subjects test.||||0.369
73967207|NCT03978871|147471621|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. An ROI mask was generated from left and right amygdala of the AAL1.V4 atlas. First-level contrast estimates (negative immerse \> neutral immerse) for each voxel within the ROI were averaged with MarsBaR to produce a single value for each person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.265||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = -1.12||||||0.265
73967208|NCT03978871|147471622|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. An ROI mask was generated from left and right amygdala of the AAL1.V4 atlas. First-level contrast estimates (negative \> neutral) for each voxel within the ROI were averaged with MarsBaR to produce a single value for each person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.96||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = -0.53||||||0.96
73967209|NCT03978871|147471623|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative reframe \> negative immerse) were extracted with MarsBaR from 15 ROIs in the FPN of a modified Schaefer atlas and the 30 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.76||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = -.3047||||||0.76
73967210|NCT03978871|147471624|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative \> neutral) were extracted with MarsBaR from 15 ROIs in the FPN of a modified Schaefer atlas and the 30 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.048||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = 1.998, p = .048||||||.048
74086679|NCT03396874|147727006|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|91.72|||<|1e-07|TWO_SIDED|95.0|86.74|100.0||p-value = 2.2e-16 Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Exact binomial proportion test|||Sensitivity, composite standard, prostate/prostate bed: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In the prostate or prostate bed, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|86.74|<0.0000001
74088468|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Participate in a specific exercise session."||||0.24
73920279|NCT02756689|147368186|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
73967211|NCT03978871|147471625|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.833|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||0.833
73967212|NCT03978871|147471626|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.321|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) across self-reported affect on the SET task. This is a test of between-subjects effect.||||0.321
73967213|NCT03978871|147471627|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.002|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) for fixed emotion mindset scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.002
73967214|NCT03978871|147471627|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.005|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on fixed emotion mindset scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons included as a covariate.||||0.005
73920280|NCT02756689|147368187|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
73920281|NCT02756689|147368188|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
73920282|NCT02756689|147368189|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
73920283|NCT02756689|147368190|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
73920284|NCT02237950|147368191|SUPERIORITY|||||||0.015|||||||Regression, Logistic|||||||0.015
73920285|NCT02237950|147368192|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
73920286|NCT02237950|147368193|SUPERIORITY|||||||0.002|||||||Regression, Logistic|||||||0.002
73920287|NCT02237950|147368194|SUPERIORITY|||||||0.014|||||||Regression, Logistic|||||||0.014
73920288|NCT02237950|147368195|SUPERIORITY|||||||0.012|||||||Regression, Logistic|||||||0.012
73920289|NCT02237950|147368196|SUPERIORITY|||||||0.059|||||||Regression, Logistic|||||||0.059
73920290|NCT02237950|147368197|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||||||0.008
73920291|NCT02663232|147368214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage (IIIC \[referral category\] versus (vs) M1a vs M1b vs M1c) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.001
73920292|NCT02663232|147368214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIC/M1a/M1b \[referral category\] vs M1c with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.196
73920293|NCT02663232|147368214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIc with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||||0.002
73920294|NCT02663232|147368214|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.716||||0.028|TWO_SIDED|95.0|1.115|6.616|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1a (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||6.616|1.115|0.028
73920295|NCT02663232|147368214|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.466||||0.142|TWO_SIDED|95.0|0.168|1.291|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1b (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||1.291|0.168|0.142
73920296|NCT02663232|147368214|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.822||||0.653|TWO_SIDED|95.0|0.351|1.928|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1c (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||1.928|0.351|0.653
73920297|NCT02663232|147368215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Family family history of melanoma (yes vs no) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.240
73920298|NCT02663232|147368216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.719|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of sun exposure yes vs no with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.719
73920299|NCT02663232|147368217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of primary tumor site (trunk \[referral category\] vs head and neck vs upper extremities vs lower extremities vs. visceral/mucosa) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.262
73920300|NCT02663232|147368218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.313|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of LDH (elevated \[referral category\] vs normal vs unknown) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.313
73920301|NCT02663232|147368219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.291|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of time since diagnosis of primary melanoma (continuous variable) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.291
73920302|NCT02663232|147368220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.164|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample source (primary tumor \[referral category\] vs metastases vs relapses) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.164
74028020|NCT01380093|147610052|SUPERIORITY_OR_OTHER||LS Mean Difference|29.1|||<|0.0001|TWO_SIDED|95.0|24.6|33.7||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.7|24.6|<0.0001
73920303|NCT02663232|147368221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample type (paraffin-embedded blocks \[referral category\] vs slides of paraffin blocks vs cytology slides) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.505
73920304|NCT02663232|147368222|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of method of fixation (buffered formalin \[referral category\] vs other) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.701
73920305|NCT02663232|147368223|SUPERIORITY_OR_OTHER_LEGACY|||||||0.683|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Berslow thickness (≤1 mm \[referral category\] vs 1.01-2 mm vs 2.01-4 mm vs 4 mm) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.683
73920306|NCT02663232|147368224|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Ulceration (no \[referral category\] vs yes) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.615
73967215|NCT03978871|147471628|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.033|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on fixed emotion mindset scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||.033
73967216|NCT03978871|147471629|SUPERIORITY|Threshold for statistical significance was p = 0.05||||||0.403|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.403
73967217|NCT03978871|147471629|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.19|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.190
73920307|NCT02663232|147368225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.949|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of presence of regression (Without regression \[referral category\] vs With regression) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.949
73920308|NCT02663232|147368226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Vascular invasion (Without vascular invasion \[referral category\] vs With vascular invasion) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.374
73967218|NCT03978871|147471630|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.784||||||degrees of freedom = 1.|ANOVA|||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.784
73967219|NCT03978871|147471630|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.586|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.586
73967220|NCT03978871|147471631|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.916|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.916
73967221|NCT03978871|147471631|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.343|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.343
74028021|NCT01380093|147610053|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.1|||<|0.0001|TWO_SIDED|95.0|-61.2|-41.0||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-41.0|-61.2|<0.0001
74028022|NCT01380093|147610053|SUPERIORITY_OR_OTHER||LS Mean Difference|24.6|||<|0.0001|TWO_SIDED|95.0|14.5|34.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.6|14.5|<0.0001
74028023|NCT01380093|147610053|SUPERIORITY_OR_OTHER||LS Mean Difference|75.7|||<|0.0001|TWO_SIDED|95.0|65.6|85.8||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||85.8|65.6|<0.0001
73920309|NCT00748033|147368274|OTHER|||||||0.065|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.0650
73920310|NCT00748033|147368275|OTHER|||||||0.2487|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.2487
73967222|NCT03978871|147471632|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.048|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.048
73967223|NCT03978871|147471632|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.153|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lesson was included as a covariate.||||0.153
73967224|NCT03978871|147471633|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.566|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD proactive engagement scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.566
73967225|NCT03978871|147471633|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.048|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.048
73920311|NCT00748033|147368276|OTHER|||||||0.7288|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.7288
73920312|NCT00748033|147368277|OTHER|||||||0.0045|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.0045
73920313|NCT00748033|147368278|OTHER|||||||0.4561|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||Testing the hypothesis that 5s and 24 h are equal at insertion.||||0.4561
73920314|NCT00748033|147368279|OTHER|||||||0.1797|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||Testing the hypothesis that 5s and 24 h are equal at withdrawal.||||0.1797
73920315|NCT00748033|147368280|OTHER|||||||0.5171|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.||||0.5171
73920316|NCT00748033|147368281|OTHER|||||||0.7105|||||||Wilcoxon (Mann-Whitney)|||The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.||||0.7105
73920317|NCT00748033|147368282|OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
73920318|NCT00748033|147368283|OTHER|||||||0.0346|||||||Wilcoxon (Mann-Whitney)|||||||0.0346
73920319|NCT00748033|147368284|OTHER|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||||||0.0016
74088469|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Check feet."||||0.18
73920320|NCT00824512|147368375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9133|TWO_SIDED|95.0||||No multiplicity adjustment performed for this study and all statistical tests are two-sided at the 5% significance level.|Non parametric ANCOVA on the rank test|The baseline value was used as a covariate.||||||0.9133
73920321|NCT02927080|147368430|SUPERIORITY|Percent Change in Total Muscle Volume (TMV) of the TA muscle in patients with FSHD administered ACE-083 when compared to placebo During Part 2 (randomized, controlled portion)|Mean Difference (Net)|9.54|STANDARD_ERROR_OF_MEAN|3.876||0.0138|TWO_SIDED|90.0|3.17|15.92|||ANCOVA|||D190 Percent change from baseline in TMV||15.92|3.17|0.0138
73920322|NCT02927080|147368430|SUPERIORITY|Percent Change in Total Muscle Volume (TMV) of the BB muscle in patients with FSHD administered ACE-083 when compared to placebo During Part 2 (randomized, controlled portion)|Mean Difference (Net)|16.39|STANDARD_ERROR_OF_MEAN|4.032|<|0.0001|TWO_SIDED|90.0|9.75|23.02|||ANCOVA|||D190 Percent change from baseline in TMV||23.02|9.75|<0.0001
73920323|NCT02927080|147368432|SUPERIORITY||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|1.299||0.0359|TWO_SIDED|90.0|-4.86|-0.59|||ANCOVA|||D190 Absolute change from baseline in FF for the TA group administered ACE-083 when compared to Placebo in part 2||-0.59|-4.86|0.0359
73920324|NCT02927080|147368432|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|1.359||0.3582|TWO_SIDED|90.0|-3.49|0.99|||ANCOVA|||D190 Absolute change from baseline in FF for the BB group administered ACE-083 when compared to Placebo in part 2||0.99|-3.49|0.3582
73920325|NCT02927080|147368433|SUPERIORITY||Mean Difference (Final Values)|-5.28|STANDARD_ERROR_OF_MEAN|4.068||0.1945|TWO_SIDED|90.0|-11.97|1.41|||ANCOVA|||D190 Percent change from baseline in 6 Minute Walk Test (MWT) distance from baseline||1.41|-11.97|0.1945
73920326|NCT02927080|147368433|SUPERIORITY||Mean Difference (Final Values)|4.69|STANDARD_ERROR_OF_MEAN|4.968||0.3451|TWO_SIDED|90.0|-3.48|12.86|||ANCOVA|||D190 Percent change from baseline in time to complete a 10 meter walk/run||12.86|-3.48|0.3451
73920327|NCT02927080|147368433|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|6.03||0.9402|TWO_SIDED|90.0|-9.47|10.37|||ANCOVA|||D190 Percent change from baseline in time to complete 4-stair climb (ascend)||10.37|-9.47|0.9402
73920328|NCT02927080|147368434|SUPERIORITY||Mean Difference (Final Values)|36.12|STANDARD_ERROR_OF_MEAN|14.18||0.0183|TWO_SIDED|90.0|11.78|60.46|||ANCOVA|||||60.46|11.78|0.0183
73920329|NCT02927080|147368435|SUPERIORITY||Mean Difference (Final Values)|2.89|STANDARD_ERROR_OF_MEAN|1.7||0.0895|TWO_SIDED|90.0|0.09|5.69|||ANCOVA|||||5.69|0.09|0.0895
73920330|NCT02927080|147368436|SUPERIORITY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|3.459||0.5661|TWO_SIDED|90.0|-7.67|3.7|||ANCOVA|||Change from baseline in FSHD-HI, patient-reported outcome (PRO) measures Part 2 (Randomized, Controlled Portion)- Total Score for TA group part 2; compared to Placebo||3.70|-7.67|0.5661
73920331|NCT02927080|147368436|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|3.618||0.976|TWO_SIDED|90.0|-6.06|5.84|||ANCOVA|||Change from baseline in FSHD-HI, patient-reported outcome (PRO) measures Part 2 (Randomized, Controlled Portion)- Total Score for BB group part 2; compared to Placebo||5.84|-6.06|0.9760
73920332|NCT02259582|147368482|SUPERIORITY|Based on RECIST v1.1. Response outcomes from an assessment done anytime less than Day 35 were considered as not evaluable unless the response assessment was progress disease.|Hazard Ratio (HR)|0.04|||=|0.0401|TWO_SIDED|95.0|0.013|0.095|||Log Rank|||The Kaplan-Meier method was used to estimate both the survival curves and the median survival time. The 95% confidence interval (CI) for the median survival time was calculated. A p-value for treatment effect was generated using a stratified Cox proportional hazards model.||.095|.013|=0.0401
73920333|NCT01067456|147368513|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.57||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
73920334|NCT01988103|147368553|SUPERIORITY_OR_OTHER_LEGACY||Difference|16.4||||0.0032|TWO_SIDED|95.0|5.8|27.0|||Chi-squared|||||27.0|5.8|0.0032
73920335|NCT01988103|147368553|SUPERIORITY_OR_OTHER_LEGACY||Difference|21.1||||0.0003|TWO_SIDED|95.0|10.1|32.1|||Chi-squared|||||32.1|10.1|0.0003
74088470|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Wash feet."||||0.19
74088471|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Soak feet."||||0.87
73920336|NCT01988103|147368554|SUPERIORITY_OR_OTHER_LEGACY||Difference|15.1||||0.0165|TWO_SIDED|95.0|3.1|27.1|||Chi-squared|||||27.1|3.1|0.0165
73920337|NCT01988103|147368554|SUPERIORITY_OR_OTHER_LEGACY||Difference|20.8||||0.002|TWO_SIDED|95.0|8.2|33.3|||Chi-squared||Missing values were imputed using the LOCF method.|||33.3|8.2|0.0020
73920338|NCT01988103|147368555|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.1||||0.0003|TWO_SIDED|95.0|-44.5|-13.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-13.6|-44.5|0.0003
73920339|NCT01988103|147368555|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.0|||<|0.0001|TWO_SIDED|95.0|-53.4|-22.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-22.6|-53.4|<0.0001
73920340|NCT01988103|147368556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.5||||0.0002|TWO_SIDED|95.0|-44.9|-14.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-14.0|-44.9|0.0002
73920341|NCT01988103|147368556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.5|||<|0.0001|TWO_SIDED|95.0|-54.9|-24.1|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-24.1|-54.9|<0.0001
73920342|NCT01988103|147368557|SUPERIORITY_OR_OTHER_LEGACY||Difference|19.7||||0.0057|TWO_SIDED|95.0|6.1|33.4|||Chi-squared|||||33.4|6.1|0.0057
73920343|NCT01988103|147368557|SUPERIORITY_OR_OTHER_LEGACY||Difference|29.2|||<|0.0001|TWO_SIDED|95.0|15.4|42.9|||Chi-squared|||||42.9|15.4|<0.0001
73920344|NCT01988103|147368558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6||||0.0003|TWO_SIDED|95.0|-22.6|-6.7|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-6.7|-22.6|0.0003
73920345|NCT01988103|147368558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.8|||<|0.0001|TWO_SIDED|95.0|-32.7|-16.9|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate. Missing values were imputed using the LOCF method.|||-16.9|-32.7|<0.0001
73920346|NCT01988103|147368559|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0204|TWO_SIDED|95.0|-3.2|-0.3|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-0.3|-3.2|0.0204
73920347|NCT01988103|147368559|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|||<|0.0001|TWO_SIDED|95.0|-4.9|-2.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-2.0|-4.9|<0.0001
73920348|NCT01988103|147368560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88||||0.5149|TWO_SIDED|95.0|-1.78|3.53|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||3.53|-1.78|0.5149
73920349|NCT01988103|147368560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.85||||0.1693|TWO_SIDED|95.0|-0.79|4.5|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||4.50|-0.79|0.1693
73920350|NCT05081011|147368618|OTHER|||||||0.006||||||A p-value of 0.05 would be considered statistically significant|Log Rank|||||||0.006
73920351|NCT05081011|147368619|OTHER||Mean Difference (Final Values)|32.7||||0.01|TWO_SIDED|95.0|8.0|57.4||A p-value of 0.05 would be considered statistically significant.|Welch 2-sample method|||||57.4|8.0|0.01
73920352|NCT05081011|147368620|OTHER||Mean Difference (Final Values)|-3.6||||0.03|TWO_SIDED|95.0|-6.8|-0.4||A p-value of 0.05 would be considered statistically significant.|Welch 2-sample method|||||-0.4|-6.8|0.03
73920353|NCT05081011|147368621|OTHER||Mean Difference (Final Values)|1.4||||0.06|TWO_SIDED|95.0|-0.03|2.8|||Welch 2-sample method|||||2.8|-0.03|0.06
73920354|NCT05081011|147368622|OTHER||Mean Difference (Final Values)|1.0||||0.46|TWO_SIDED|95.0|-1.6|3.5|||Welch 2-sample method|||||3.5|-1.6|0.46
73920355|NCT05081011|147368623|OTHER||Mean Difference (Final Values)|0.56||||0.005|TWO_SIDED|95.0|0.21|0.91|||2-sample test|2-sample test for equality of proportions with Yates continuity correction|Comparison of percentage (proportion) of participants achieving glycemic control.|Comparison of percentage (proportion) of participants achieving glycemic control.||0.91|0.21|0.005
73920356|NCT05081011|147368624|OTHER||Mean Difference (Final Values)|-68.9||||0.001|TWO_SIDED|95.0|-107.1|-30.1|||Welch 2-sample method|||||-30.1|-107.1|0.001
73920357|NCT01949051|147368626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.943|-0.756|||Mixed Model ANOVA|||||-0.756|-1.943|<0.0001
73920358|NCT01949051|147368626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.118||||0.0003|TWO_SIDED|95.0|-1.712|-0.525|||Mixed Model ANOVA|||||-0.525|-1.712|0.0003
73920359|NCT01949051|147368626|NON_INFERIORITY_OR_EQUIVALENCE|Levocabastine OD would be declared as non-inferior to levocabastine BID if upper limit of 95% confidence interval of the treatment difference estimate (OD vs BD) was less than 1|Mean Difference (Final Values)|0.231|||||TWO_SIDED|95.0|-0.361|0.823||||||||0.823|-0.361|
73920360|NCT02611778|147368634|EQUIVALENCE|The confidence interval (CI) for treatment difference (FYB201 - Lucentis) was calculated using Least Square Means. If the 90% CI was completely contained in the interval \]-3.5;3.5\[ ETDRS letters, equivalence of FYB201 and Lucentis could be concluded.|Difference in least square means|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.6|0.9|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 8 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|The hypothesis of biosimilarity of FYB201 and Lucentis was tested with a two-sided equivalence test with an equivalence margin of 3 ETDRS letters. An ANCOVA model was used with the change in BCVA between baseline and Week 8 as the dependent variable, the baseline BCVA as covariate, and the country and the treatment group as fixed effects.||0.9|-1.6|
73920361|NCT02611778|147368635|OTHER||Difference in least square means|0.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|90.0|-1.6|1.5|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 24 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.5|-1.6|
73920362|NCT02611778|147368636|OTHER||Difference in least square means|-0.1|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|90.0|-1.8|1.7|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 48 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.7|-1.8|
73920363|NCT02611778|147368637|OTHER||Difference in least square means|0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.6|1.8|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and 12 months (average of Weeks 40, 44 and 48) as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.8|-1.6|
73920364|NCT02611778|147368638|OTHER||Difference in least square means|0.69|STANDARD_ERROR_OF_MEAN|11.469|||TWO_SIDED|90.0|-18.22|19.6|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCP retinal thickness between baseline and Week 24 as the dependent variable, the baseline FCP retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||19.60|-18.22|
73920365|NCT02611778|147368639|OTHER||Difference in least square means|2.68|STANDARD_ERROR_OF_MEAN|11.632|||TWO_SIDED|90.0|-16.49|21.85|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCP retinal thickness between baseline and Week 48 as the dependent variable, the baseline FCP retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||21.85|-16.49|
73920366|NCT02611778|147368640|OTHER||Difference in least square means|-5.91|STANDARD_ERROR_OF_MEAN|10.136|||TWO_SIDED|90.0|-22.62|10.8|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCS retinal thickness between baseline and Week 24 as the dependent variable, the baseline FCS retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||10.80|-22.62|
73920367|NCT02611778|147368641|OTHER||Difference in least square means|3.68|STANDARD_ERROR_OF_MEAN|10.285|||TWO_SIDED|90.0|-13.28|20.63|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCS retinal thickness between baseline and Week 48 as the dependent variable, the baseline FCS retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||20.63|-13.28|
73920368|NCT02611778|147368642|OTHER||Difference in least square means|0.07|STANDARD_ERROR_OF_MEAN|0.4709|||TWO_SIDED|90.0|-0.706|0.846|||ANCOVA||An ANCOVA model was used for the analysis with the change in total lesion area between baseline and Week 24 as the dependent variable, the baseline total lesion area as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||0.846|-0.706|
73920369|NCT02611778|147368643|OTHER||Difference in least square means|0.342|STANDARD_ERROR_OF_MEAN|0.5387|||TWO_SIDED|90.0|-0.547|1.23|||ANCOVA||An ANCOVA model was used for the analysis with the change in total lesion area between baseline and Week 48 as the dependent variable, the baseline total lesion area as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.230|-0.547|
73920370|NCT02611778|147368644|OTHER||Difference in least square means|0.21|STANDARD_ERROR_OF_MEAN|0.886|||TWO_SIDED|90.0|-1.25|1.67|||ANCOVA||An ANCOVA model was used for the analysis with change in NEI VFQ-25 composite score between baseline and Week 24 as dependent variable, baseline NEI VFQ-25 composite score as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.67|-1.25|
73920371|NCT02611778|147368645|OTHER||Difference in least square means|1.73|STANDARD_ERROR_OF_MEAN|1.027|||TWO_SIDED|90.0|0.04|3.42|||ANCOVA||An ANCOVA model was used for the analysis with change in NEI VFQ-25 composite score between baseline and Week 48 as dependent variable, baseline NEI VFQ-25 composite score as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||3.42|0.04|
73920372|NCT02956486|147368673|SUPERIORITY||Least Square (LS) Mean Difference|-0.17||||0.385|TWO_SIDED|95.0|-0.57|0.22|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (mild cognitive impairment \[MCI\]/Prodromal, mild alzheimer's disease \[AD\]), concurrent AD medication use, region, apolipoprotein E (ApoE4) status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.22|-0.57|0.385
73920373|NCT02956486|147368675|SUPERIORITY||LS Mean Difference|-0.02||||0.345|TWO_SIDED|95.0|-0.06|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.02|-0.06|0.345
73920374|NCT02956486|147368676|SUPERIORITY||LS Mean Difference|-12.83|||<|0.001|TWO_SIDED|95.0|-18.79|-6.88|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||-6.88|-18.79|<.001
74028024|NCT01380093|147610054|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.9|||<|0.0001|TWO_SIDED|95.0|-11.8|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-6.0|-11.8|<0.0001
74028025|NCT01380093|147610054|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.0006|TWO_SIDED|95.0|2.3|8.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.1|2.3|0.0006
73920375|NCT02956486|147368677|SUPERIORITY||LS Mean Difference|-0.23||||0.316|TWO_SIDED|95.0|-0.67|0.22|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.22|-0.67|0.316
73967226|NCT03978871|147471633|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.266|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.266
73920376|NCT02956486|147368678|SUPERIORITY||LS Mean Difference|-0.03||||0.254|TWO_SIDED|95.0|-0.07|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.02|-0.07|0.254
73967227|NCT03978871|147471633|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.402|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.402
73920377|NCT02956486|147368679|SUPERIORITY||Difference of Mean Slope|-0.008||||0.9088|TWO_SIDED|95.0|-0.145|0.129|||Linear mixed effects model|||Based on the linear mixed effects model, which included assessment time and treatment group by assessment time interaction as covariate with random intercept and slope.||0.129|-0.145|0.9088
73920378|NCT02956486|147368680|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.6155|TWO_SIDED|95.0|0.77|1.16|||Regression, Cox|||Based on a Cox regression model which included treatment group, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, APOE4 status (positive, negative) as covariate.||1.16|0.77|0.6155
73920379|NCT02956486|147368681|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.1281|TWO_SIDED|95.0|0.96|1.35|||Regression, Cox|||Based on a Cox regression model which included treatment group, concurrent AD medication use, region, APOE4 status (positive, negative) as covariate.||1.35|0.96|0.1281
73920380|NCT02956486|147368682|SUPERIORITY||LS Mean Difference|-0.43||||0.525|TWO_SIDED|95.0|-1.75|0.9|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.90|-1.75|0.525
73920381|NCT02956486|147368683|SUPERIORITY||LS Mean Difference|-0.01||||0.977|TWO_SIDED|95.0|-0.64|0.62|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.62|-0.64|0.977
73967228|NCT03978871|147471634|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.363|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD proactive engagement from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.363
74028026|NCT01380093|147610054|SUPERIORITY_OR_OTHER||LS Mean Difference|14.1|||<|0.0001|TWO_SIDED|95.0|11.2|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17.0|11.2|<0.0001
74028027|NCT01380093|147610055|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.8|||<|0.0001|TWO_SIDED|95.0|-62.0|-35.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.5|-62.0|<0.0001
74086680|NCT03396874|147727006|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|90.78|||<|1e-07|TWO_SIDED|95.0|85.74|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, pelvic lymph nodes: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|85.74|<0.0000001
74028028|NCT01380093|147610055|SUPERIORITY_OR_OTHER||LS Mean Difference|29.0|||<|0.0001|TWO_SIDED|95.0|15.8|42.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||42.3|15.8|<0.0001
74088472|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Dry between toes."||||0.53
73920382|NCT02956486|147368684|SUPERIORITY||LS Mean Difference|0.11||||0.854|TWO_SIDED|95.0|-1.09|1.32|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||1.32|-1.09|0.854
73967229|NCT03978871|147471634|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.363|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.363
73967230|NCT03978871|147471634|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.583|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.583
73967231|NCT03978871|147471634|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.379|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.379
73920383|NCT02956486|147368685|SUPERIORITY||LS Mean Difference|-0.27||||0.314|TWO_SIDED|95.0|-0.79|0.26|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.26|-0.79|0.314
73920384|NCT02956486|147368686|SUPERIORITY||LS Mean Difference|0.07||||0.895|TWO_SIDED|95.0|-0.93|1.07|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||1.07|-0.93|0.895
74028029|NCT01380093|147610055|SUPERIORITY_OR_OTHER||LS Mean Difference|77.8|||<|0.0001|TWO_SIDED|95.0|64.5|91.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||91.0|64.5|<0.0001
74028030|NCT01380093|147610056|SUPERIORITY_OR_OTHER||LS Mean Difference|-68.6|||<|0.0001|TWO_SIDED|95.0|-95.0|-42.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-42.2|-95.0|<0.0001
74028031|NCT01380093|147610056|SUPERIORITY_OR_OTHER||LS Mean Difference|56.5|||<|0.0001|TWO_SIDED|95.0|30.1|82.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||82.8|30.1|<0.0001
74028032|NCT01380093|147610056|SUPERIORITY_OR_OTHER||LS Mean Difference|125.1|||<|0.0001|TWO_SIDED|95.0|98.7|151.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||151.5|98.7|<0.0001
74086681|NCT03396874|147727006|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|96.97|||<|1e-07|TWO_SIDED|95.0|93.2|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, pelvic lymph nodes: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In pelvic lymph nodes, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|93.20|<0.0000001
73920385|NCT02956486|147368687|SUPERIORITY||LS Mean Difference|0.04||||0.542|TWO_SIDED|95.0|-0.09|0.17|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.17|-0.09|0.542
73920386|NCT02956486|147368688|SUPERIORITY||LS Mean Difference|-0.01||||0.38|TWO_SIDED|95.0|-0.02|0.01|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.01|-0.02|0.380
73920387|NCT02956486|147368689|SUPERIORITY||LS Mean Difference|-0.4||||0.063|TWO_SIDED|95.0|-0.82|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.02|-0.82|0.063
73920388|NCT02956486|147368690|SUPERIORITY||LS Mean Difference|-0.56||||0.045|TWO_SIDED|95.0|-1.11|-0.01|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||-0.01|-1.11|0.045
73920389|NCT02956486|147368691|SUPERIORITY||LS Mean Difference|-0.04||||0.799|TWO_SIDED|95.0|-0.32|0.24|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.24|-0.32|0.799
73920390|NCT02956486|147368692|SUPERIORITY||LS Mean Difference|-0.32||||0.012|TWO_SIDED|95.0|-0.56|-0.07|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||-0.07|-0.56|0.012
74028033|NCT01380093|147610057|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.0||||0.0001|TWO_SIDED|95.0|-112.8|-39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-39.2|-112.8|0.0001
74028034|NCT01380093|147610057|SUPERIORITY_OR_OTHER||LS Mean Difference|66.5||||0.0006|TWO_SIDED|95.0|29.8|103.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||103.2|29.8|0.0006
73920391|NCT00345254|147368709|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
73920392|NCT00862745|147368729|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustment for multiple comparisons, threshold for significance is P \< .05|ANCOVA|Mean difference=Drug A minus Drug B||Null hypothesis: fesoterodine treatment is not associated with greater reduction in urgency incontinence frequency compared to placebo in women diagnosed using the 3IQ||||<0.001
73920393|NCT03336853|147368747|SUPERIORITY||Mean Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.66|0.82|||t-test, 2 sided|||||0.82|0.66|<.0001
73920394|NCT00667368|147368748|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.9||||0.754|TWO_SIDED|95.0|-12.0|10.1|||Two-sample test, Poisson||The risk difference reflects the treatment arm minus the control arm. The units are the number of positive tests for chlamydia and gonorrhea per 100 person-years.|||10.1|-12.0|0.754
73920395|NCT00667368|147368749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73967232|NCT03978871|147471634|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.246|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.246
73967233|NCT03978871|147471635|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. 12 ROI masks were generated from the CON network of a modified Schaefer atlas. First-level contrast estimates (negative reframe \> negative immerse) for each voxel within each ROI were averaged with MarsBaR to produce 12 values for each person. These were then averaged to produce a single value each.A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control)||||||0.455||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = .75||||||0.455
73967234|NCT03978871|147471636|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. 12 ROI masks were generated from the CON network of a modified Schaefer atlas. First-level contrast estimates (negative \> neutral) for each voxel within each ROI were averaged with MarsBaR to produce 12 values for each person. These were subsequently averaged to produce a single value per person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.43||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(145) = 0.80||||||0.43
73967235|NCT03978871|147471637|SUPERIORITY|BOLD signals were spatially averaged within ROIs to produce a single time series for each ROI. Timeseries were averaged to produce a single value representing each ROI's mean activity. Values for each ROI were then averaged to produce a single value per person representing mean network activity. These values were then submitted to a two-sample t-test to test for differences across intervention groups (mindset vs control).||||||0.29||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(142) = -1.057||||||0.29
73967236|NCT03978871|147471638|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative reframe \> negative immerse) were extracted with MarsBaR from 12 ROIs in the CON of a modified Schaefer atlas and the 24 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.88||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = 0.148||||||0.88
73920396|NCT00732615|147368754|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|52.3|||<|0.001|TWO_SIDED|95.0|40.6|64.0||A fixed sequence test procedure was used to control the study level type I error. Order of test sequence started with the primary efficacy endpoint and proceeded to the 3 secondary efficacy endpoints, in the order defined in the protocol.|Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference between NPSP558 and the placebo treatment groups.|The above two sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis is that the % of subjects meeting primary efficacy endpoint criteria are the same for both tmt arms. The sample size was determined based on the assumption that 40% and 10% of subjects for NPSP558 and pbo arms would meet the endpt criteria, respectively. Based on 2-tailed test, alpha of 0.05 and 2-to-1 randomization ratio, 84 (56 NPSP558, 28 pbo) subjects who completing the study would achieve 80% statistical power. Adjusted for dropouts, planned enrollment was 110 subjects.||64.0|40.6|<0.001
73967237|NCT03978871|147471639|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative \> neutral) were extracted with MarsBaR from 12 ROIs in the CON of a modified Schaefer atlas and the 24 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.11||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = 1.631||||||.11
73967238|NCT03978871|147471640|SUPERIORITY|BOLD signals were spatially averaged within ROIs to produce a single time series for each ROI. Pearson correlations were calculated between each mean BOLD signal in the CON and each amygdala ROI to produce 24 connectivity values. These were averaged to produce a single value representing the strength of coupling of the CON network to the amygdala for each participant. These values were then submitted to a two-sample t-test to test for differences across intervention groups (mindset vs control).||||||0.92||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(142) = 0.101||A two-sample t-test was conducted to compare average connectivity (between the amygdala and the CON network) during resting state between the mindset and control groups.||||0.92
73967239|NCT03978871|147471641|OTHER|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||2.22e-05||||||Reported result for cluster localized in the Superior/Middle Temporal Gyrus (Right). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000222
73967240|NCT03978871|147471641|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.17e-05||||||Reported result for cluster localized in the Middle Temporal Gyrus (Left). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000117
74028035|NCT01380093|147610057|SUPERIORITY_OR_OTHER||LS Mean Difference|142.5|||<|0.0001|TWO_SIDED|95.0|105.7|179.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||179.3|105.7|<0.0001
74088473|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Inspect inside of shoes."||||0.32
73920397|NCT00732615|147368755|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the primary endpoint reached statistical significance.|ANCOVA|ANCOVA analysis conducted using percentage change from baseline as dependent variable, treatment as factor, and baseline calcium dose as covariate.||The null hypothesis is that there is no difference between the percentage changes from baseline for the two treatment arms.||||<0.001
73920398|NCT00732615|147368756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.711|||<|0.001|TWO_SIDED|95.0|2.619|52.363||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the first secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the proportions of subjects (who achieved this secondary endpoint) from the two treatment arms.||52.363|2.619|<0.001
73920399|NCT00732615|147368757|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.879||||0.747|TWO_SIDED|95.0|0.402|1.922||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the second secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that the percentages of subjects with any reported clinical symptoms for the two treatment arms are the same.||1.922|0.402|0.747
73920400|NCT02622321|147368794|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.13|||<|0.0001|TWO_SIDED|95.0|0.057|0.277||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (less than \[\<\] 9 or greater than or equal to \[\>/=\] 9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.277|0.057|<0.0001
73920401|NCT02622321|147368795|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.2|||<|0.0001|TWO_SIDED|95.0|0.102|0.375||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.375|0.102|<0.0001
73920402|NCT02622321|147368796|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.11|||<|0.0001|TWO_SIDED|95.0|0.055|0.218||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.||0.218|0.055|<0.0001
73920403|NCT02622321|147368797|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.031|0.198||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.||0.198|0.031|<0.0001
73920404|NCT02622321|147368798|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.11||||0.005|TWO_SIDED|95.0|0.025|0.52||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.520|0.025|0.0050
73920405|NCT02622321|147368799|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.119|0.435||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.||0.435|0.119|<0.0001
73920406|NCT02622321|147368800|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.21||||0.0003|TWO_SIDED|95.0|0.089|0.486||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.||0.486|0.089|0.0003
73967241|NCT03978871|147471641|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||0||||||"Reported result for cluster localized in the Anterior Cingulate/Medial Frontal Gyrus.~FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels."|t-test, 2 sided|||||||.000000000
73967242|NCT03978871|147471641|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.86e-05||||||Reported result for cluster localized in the Middle Frontal Gyrus (Right). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000186
74028036|NCT01380093|147610058|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.2||||0.0011|TWO_SIDED|95.0|-136.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.9|-136.5|0.0011
74028037|NCT01380093|147610058|SUPERIORITY_OR_OTHER||LS Mean Difference|69.8||||0.0071|TWO_SIDED|95.0|19.7|120.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||120.0|19.7|0.0071
73920407|NCT02622321|147368801|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.037|0.154||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.154|0.037|<0.0001
73920408|NCT02622321|147368802|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.05||||0.0002|TWO_SIDED|95.0|0.009|0.227||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.227|0.009|0.0002
73920409|NCT02622321|147368806|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|21.55||||0.0029|TWO_SIDED|95.0|7.89|35.22||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm. Analysis was performed using Analysis of Covariance (ANCOVA).||35.22|7.89|0.0029
73920410|NCT02622321|147368807|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|14.01||||0.0019|TWO_SIDED|95.0|5.56|22.45||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||22.45|5.56|0.0019
73920411|NCT02622321|147368808|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-9.72||||0.0171|TWO_SIDED|95.0|-17.62|-1.82||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||-1.82|-17.62|0.0171
73920412|NCT02622321|147368809|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.16||||0.0014|TWO_SIDED|95.0|-0.25|-0.07||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||-0.07|-0.25|0.0014
73920413|NCT00965718|147368830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.123||||||Global health status scores at baseline and final observation point were compared via a 2-sided t-test.|t-test, 2 sided|||||||0.123
73967243|NCT03978871|147471641|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||0||||||Reported result for cluster localized in the Middle Frontal Gyrus (Left). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.000000000
73967244|NCT03978871|147471641|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.61e-05||||||Reported result for cluster localized in the Posterior Cingulate/Cingulate. FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000161
73967245|NCT03978871|147471641|OTHER|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative reframe \> negative immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005.|||||>|0.001||||||pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 298 voxels.|t-test, 2 sided|||||||>.001
73967246|NCT03978871|147471642|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.56|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on depression levels from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.560
73967247|NCT03978871|147471643|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.327|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on depression levels from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.327
74028038|NCT01380093|147610058|SUPERIORITY_OR_OTHER||LS Mean Difference|156.0|||<|0.0001|TWO_SIDED|95.0|105.7|206.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||206.3|105.7|<0.0001
74028039|NCT01380093|147610059|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.1254|TWO_SIDED|95.0|-0.6|4.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.7|-0.6|0.1254
74028040|NCT01380093|147610059|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.4592|TWO_SIDED|95.0|-3.6|1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.6|-3.6|0.4592
73967248|NCT03978871|147471644|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.439|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.439
73920414|NCT00147199|147368853|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate|20.0||||0.00044|TWO_SIDED|95.0|8.0|32.8|||ANCOVA|Lowest rank was assigned for death, discontinuation due to disease progression, and for patients who initiated additional approved PAH therapy.||Sample size was calculated based on the primary endpoint; change in 6MWD at Week 12. Assuming a between-treatment difference of 35m, a standard deviation of 75m, and a type I (alpha) error of 0.05 (i.e., two-sided p-value of less than 0.05), in order to have 90% power to detect this difference, 100 subjects per treatment group were required for this trial (total n=200). This allowed for a dropout rate of 10% as 110 subjects per group was planned.||32.8|8.0|0.00044
73920415|NCT00147199|147368855|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.623|TWO_SIDED|95.0|-0.5|0.0|||Wilcoxon rank sum test|||||0.0|-0.5|0.623
73920416|NCT00147199|147368856|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.807|TWO_SIDED|95.0|0.0|0.0||Imputation strategies were implemented for 16 inhaled treprostinil subjects and 9 placebo subjects without values reported at Week 12|Wilcoxon rank sum test|||||0.0|0.0|0.807
73920417|NCT00147199|147368857|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|13.7||||0.007|TWO_SIDED|95.0|4.0|24.8|||ANCOVA|||||24.8|4.0|0.007
73920418|NCT00147199|147368858|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|18.5||||0.0003|TWO_SIDED|95.0|8.5|28.3|||Wilcoxon rank sum test|||||28.3|8.5|0.0003
73920419|NCT00147199|147368859|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-4.0||||0.027|TWO_SIDED|95.0|-8.0|0.0|||Wilcoxon rank sum test|||Global Score||0|-8.0|0.027
73920420|NCT00147199|147368859|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-2.0||||0.037|TWO_SIDED|95.0|-3.0|0.0|||Wilcoxon rank sum test|||Physical Dimension||0.0|-3.0|0.037
73920421|NCT00147199|147368859|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-1.0||||0.173|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon rank sum test|||Emotional Dimension Score||0.0|-2.0|0.173
73967249|NCT03978871|147471644|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.545|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.545
73967250|NCT03978871|147471645|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.74|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.740
74028041|NCT01380093|147610059|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0||||0.0251|TWO_SIDED|95.0|-5.6|-0.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.4|-5.6|0.0251
74088474|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Follow healthful eating plan."||||0.37
73920422|NCT00147199|147368861|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-167.0||||0.001|TWO_SIDED|95.0|-333.0|-64.0|||Wilcoxon rank sum test|||||-64|-333|0.001
73920423|NCT01850524|147368868|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.073|TWO_SIDED|95.0|0.676|1.018|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.||||1.018|0.676|0.073
73920424|NCT01850524|147368869|SUPERIORITY||Hazard Ratio (HR)|0.998||||0.988|TWO_SIDED|95.0|0.79|1.261|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an Unadjusted Cox's proportional hazard regression model is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.261|0.790|0.988
73920425|NCT01850524|147368870|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.43|3.09|||Cochran-Mantel-Haenszel|CMH test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Odds ratio and confidence interval are based on logistic regression model with treatment group as categorical predictor variable,age(\<75 years vs \>=75), ISS(stage I or II vs stage III),and BPI-SF worst pain score(\<4 vs \>=4)at screening as covariates.|||3.09|1.43|<0.001
73920426|NCT01850524|147368871|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9195|TWO_SIDED|95.0|0.656|1.463|||Regression, Logistic|Logistic regression model with prognostic factor: age (\<75 years vs \>=75) and ISS (stage I or II vs stage III).|Odds ratio \> 1 favors Ixazomib+LenDex versus LenDex alone.|||1.463|0.656|0.9195
73920427|NCT01850524|147368872|SUPERIORITY||Odds Ratio (OR)|1.16||||0.436|TWO_SIDED|95.0|0.79|1.7|||Cochran-Mantel-Haenszel|CMH test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Odds ratio and confidence interval are based on logistic regression model with treatment group as categorical predictor variable,age(\<75 years vs \>=75), ISS(stage I or II vs stage III),and BPI-SF worst pain score(\<4 vs \>=4)at screening as covariates.|||1.70|0.79|0.436
73920428|NCT01850524|147368873|SUPERIORITY||Hazard Ratio (HR)|1.402|||<|0.001|TWO_SIDED|95.0|1.185|1.659|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.659|1.185|<0.001
73920429|NCT01850524|147368875|SUPERIORITY||Hazard Ratio (HR)|0.738||||0.008|TWO_SIDED|95.0|0.589|0.925|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||0.925|0.589|0.008
73967251|NCT04391894|147471671|SUPERIORITY||Least Squares Mean (LS Mean)|-1.1|STANDARD_ERROR_OF_MEAN|2.01||0.585|TWO_SIDED|95.0|-5.0|2.8|||Mixed Models Analysis|||||2.8|-5.0|0.585
73967252|NCT04391894|147471671|SUPERIORITY||Least Squares Mean (LS Mean)|-3.2|STANDARD_ERROR_OF_MEAN|2.0||0.107|TWO_SIDED|95.0|-7.01|0.7|||Mixed Models Analysis|||||0.7|-7.01|0.107
73967253|NCT04391894|147471671|SUPERIORITY||Least Squares Mean (LS Mean)|4.3|STANDARD_ERROR_OF_MEAN|2.02||0.033|TWO_SIDED|95.0|0.3|8.3|||Mixed Models Analysis|||||8.3|0.3|0.033
73920430|NCT01850524|147368876|SUPERIORITY||Hazard Ratio (HR)|0.859||||0.189|TWO_SIDED|95.0|0.684|1.078|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.078|0.684|0.189
73920431|NCT01850524|147368882|SUPERIORITY||Hazard Ratio (HR)|1.118||||0.662|TWO_SIDED|95.0|0.678|1.845|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|OS in High-risk Population Carrying Del(17p), Amp(1q21), t(4;14), or t(14;16) Mutations||1.845|0.678|0.662
73920432|NCT01850524|147368883|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.271|TWO_SIDED|95.0|0.466|1.24|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|PFS in High-risk Population Carrying del(17p), t(4;14), or t(14;16) Mutations||1.240|0.466|0.271
73920433|NCT01850524|147368885|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.26|TWO_SIDED|95.0|0.661|1.12|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Time to Pain Progression||1.120|0.661|0.260
73920434|NCT02671422|147368913|OTHER||1 year-survival rate|0.342|||||TWO_SIDED|95.0|0.0|0.894|||||Confidence interval is computed based on the LOGLOG method.|||0.894|0.000|
73920435|NCT04772755|147368914|SUPERIORITY|||||||0.0249|||||||Chi-squared|||||||0.0249
73920436|NCT04772755|147368915|SUPERIORITY|||||||0.8918|||||||Mantel Haenszel|||||||0.8918
73920437|NCT04772755|147368916|SUPERIORITY|||||||0.6587|||||||Wilcoxon (Mann-Whitney)|||||||0.6587
73920438|NCT04772755|147368917|SUPERIORITY|||||||0.0059|||||||Wilcoxon (Mann-Whitney)|||||||0.0059
73920439|NCT04772755|147368918|SUPERIORITY|||||||0.1647|||||||Chi-squared|||||||0.1647
73920440|NCT04772755|147368919|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.0090
73920441|NCT04772755|147368920|SUPERIORITY|||||||0.0273|||||||Wilcoxon (Mann-Whitney)|||||||0.0273
73920442|NCT04772755|147368921|SUPERIORITY|||||||0.0458|||||||Chi-squared|||||||0.0458
74028042|NCT01380093|147610060|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.4|||<|0.0001|TWO_SIDED|95.0|-19.9|-11.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.0|-19.9|<0.0001
74028043|NCT01380093|147610060|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3|||<|0.0001|TWO_SIDED|95.0|4.8|13.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||13.7|4.8|<0.0001
73920443|NCT04772755|147368922|SUPERIORITY|||||||0.0976|||||||Chi-squared|||||||0.0976
73920444|NCT01905657|147368927|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.54||||0.00024|TWO_SIDED|95.0|0.38|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.77|0.38|0.00024
73920445|NCT01905657|147368927|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.5||||2e-05|TWO_SIDED|95.0|0.36|0.7|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.70|0.36|0.00002
73920446|NCT01905657|147368927|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.71||||0.00076|TWO_SIDED|95.0|0.58|0.88|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.88|0.58|0.00076
73920447|NCT01905657|147368927|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.49|0.75|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.75|0.49|<0.00001
73920448|NCT01905657|147368928|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.58||||9e-05|TWO_SIDED|95.0|0.43|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.77|0.43|0.00009
73920449|NCT01905657|147368928|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.59||||7e-05|TWO_SIDED|95.0|0.45|0.78|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.78|0.45|0.00007
73920450|NCT01905657|147368928|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.88||||0.06758|TWO_SIDED|95.0|0.73|1.04|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||1.04|0.73|0.06758
73920451|NCT01905657|147368928|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.79||||0.00462|TWO_SIDED|95.0|0.66|0.94|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.94|0.66|0.00462
73920452|NCT01905657|147368931|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|-2.3||||0.66608|TWO_SIDED|95.0|-12.7|8.2||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage not equal to 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with strongly PD-L1 positive tumors||8.2|-12.7|0.66608
73920453|NCT01905657|147368931|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|22.2|||<|1e-05|TWO_SIDED|95.0|14.0|30.7||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with strongly PD-L1 positive tumors||30.7|14.0|<0.00001
73920454|NCT01905657|147368931|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|8.7||||0.00045|TWO_SIDED|95.0|3.6|13.9||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with PD-L1 positive tumors||13.9|3.6|0.00045
74028044|NCT01380093|147610060|SUPERIORITY_OR_OTHER||LS Mean Difference|24.7|||<|0.0001|TWO_SIDED|95.0|20.3|29.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||29.1|20.3|<0.0001
74028045|NCT01380093|147610061|SUPERIORITY_OR_OTHER||LS Mean Difference|-116.1|||<|0.0001|TWO_SIDED|95.0|-136.5|-95.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-95.7|-136.5|<0.0001
73920455|NCT01905657|147368931|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|9.1||||0.00024|TWO_SIDED|95.0|4.1|14.3||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with PD-L1 positive tumors||14.3|4.1|0.00024
73920456|NCT04702997|147368933|SUPERIORITY||LS Mean difference (Net)|7.71|STANDARD_ERROR_OF_MEAN|1.268|<|0.0001|TWO_SIDED|95.0|5.18|10.24||KDIGO strata, treatment group, time (Week 1 to 12), and the interaction between treatment and time were used as fixed factors.|Mixed Models Analysis||Difference is bardoxolone methyl - placebo|||10.24|5.18|<0.0001
73920457|NCT02879305|147368963|NON_INFERIORITY|Non-inferiority was achieved if the upper limit of the two-sided 95% CI for the hazard ratio was below the pre-specified non-inferiority margin of 1.25.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.81|1.07|||||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.81|
73920458|NCT02879305|147368964|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than -0.75 g/dL.|Least square (LS) mean difference|0.18|||||TWO_SIDED|95.0|0.12|0.24|||||Analysis of covariance (ANCOVA) model adjusted for treatment, Baseline Hgb, dialysis type and region along with 95% CI for treatment difference (daprodustat-rhEPO).|||0.24|0.12|
73920459|NCT02879305|147368965|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.156123|TWO_SIDED|95.0|0.81|1.07||The p-value was compared against 0.0125 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.81|0.156123
73920460|NCT02879305|147368966|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.023539|TWO_SIDED|95.0|0.78|1.0||The p-value was compared against 0.006250 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.00|0.78|0.023539
73920461|NCT02879305|147368967|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.325797|TWO_SIDED|95.0|0.85|1.11||The p-value was compared against 0.025000 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.11|0.85|0.325797
73920462|NCT02879305|147368968|SUPERIORITY||LS mean difference|-9.1||||0.026947|TWO_SIDED|95.0|-18.4|0.2||The p-value was compared against 0.008333 based on the Holm-Bonferonni adjustment.|ANCOVA||Analysis was carried out by using ANCOVA model with terms for treatment, Baseline monthly IV iron dose, dialysis type and region.|||0.2|-18.4|0.026947
74028046|NCT01380093|147610061|SUPERIORITY_OR_OTHER||LS Mean Difference|59.7|||<|0.0001|TWO_SIDED|95.0|39.3|80.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||80.1|39.3|<0.0001
74028047|NCT01380093|147610061|SUPERIORITY_OR_OTHER||LS Mean Difference|175.8|||<|0.0001|TWO_SIDED|95.0|155.4|196.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||196.2|155.4|<0.0001
74028048|NCT01380093|147610062|SUPERIORITY_OR_OTHER||LS Mean Difference|-202.2|||<|0.0001|TWO_SIDED|95.0|-239.0|-165.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-165.3|-239.0|<0.0001
73920463|NCT02879305|147368969|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.3281|TWO_SIDED|95.0|0.82|1.13|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.13|0.82|0.3281
73920464|NCT02879305|147368970|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3553|TWO_SIDED|95.0|0.74|1.23|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.23|0.74|0.3553
73920465|NCT02879305|147368971|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0524|TWO_SIDED|95.0|0.63|1.04|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.04|0.63|0.0524
73920466|NCT02879305|147368972|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1927|TWO_SIDED|95.0|0.56|1.25|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.25|0.56|0.1927
73920467|NCT02879305|147368973|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.0351|TWO_SIDED|95.0|0.8|1.01|||Chi-squared||Overall HR is presented using Model 1. Model 1 assumed a common treatment effect, regardless of number of events experienced. HR was estimated using a Prentice, Williams and Peterson(PWP) model, with treatment, dialysis type and region as covariates.|||1.01|0.80|0.0351
73920468|NCT02879305|147368973|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3258|TWO_SIDED|95.0|0.85|1.11|||Chi-squared||First Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. Hazard Ratio (HR) was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.11|0.85|0.3258
73920469|NCT02879305|147368973|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0158|TWO_SIDED|95.0|0.58|0.98|||Chi-squared||Second Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||0.98|0.58|0.0158
73920470|NCT02879305|147368973|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0981|TWO_SIDED|95.0|0.47|1.17|||Chi-squared||Third Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.17|0.47|0.0981
73920471|NCT02879305|147368973|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3258|TWO_SIDED|95.0|0.85|1.11|||Chi-squared||First Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.11|0.85|0.3258
73920472|NCT02879305|147368973|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0058|TWO_SIDED|95.0|0.6|0.94|||Chi-squared||Subsequent Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||0.94|0.60|0.0058
73920473|NCT02879305|147368974|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0872|TWO_SIDED|95.0|0.73|1.06|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.06|0.73|0.0872
73920474|NCT02879305|147368975|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.154|TWO_SIDED|95.0|0.87|1.04|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.04|0.87|0.1540
73967254|NCT04391894|147471672|SUPERIORITY||Least Squares Mean (LS Mean)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.605|TWO_SIDED|95.0|-0.8|0.4|||Mixed Models Analysis|||||0.4|-0.8|0.605
73967255|NCT04391894|147471672|SUPERIORITY||Least Squares Mean (LS Mean)|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.646|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.646
73967256|NCT04391894|147471672|SUPERIORITY||Least Squares Mean (LS Mean)|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.847|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||||0.7|-0.5|0.847
73967257|NCT04391894|147471673|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
74028049|NCT01380093|147610062|SUPERIORITY_OR_OTHER||LS Mean Difference|122.5|||<|0.0001|TWO_SIDED|95.0|85.7|159.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||159.2|85.7|<0.0001
74088475|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Space carbohydrates."||||0.72
73920475|NCT02879305|147368976|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.1244|TWO_SIDED|95.0|0.77|1.07|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.77|0.1244
73920476|NCT02879305|147368977|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.054|TWO_SIDED|95.0|0.81|1.02|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.02|0.81|0.0540
73920477|NCT02879305|147368978|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.7658|TWO_SIDED|95.0|0.84|1.45|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.45|0.84|0.7658
73920478|NCT02879305|147368979|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0425|TWO_SIDED|95.0|0.69|1.02|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.02|0.69|0.0425
73920479|NCT02879305|147368980|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.12|||||TWO_SIDED|95.0|0.03|0.21||||||||0.21|0.03|
73967258|NCT04391894|147471673|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.3|0.1||||||||0.1|-0.3|
73967259|NCT04391894|147471673|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
73967260|NCT04391894|147471674|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
73967261|NCT04391894|147471674|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.3|0.1||||||||0.1|-0.3|
73967262|NCT04391894|147471674|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.1|0.6||||||||0.6|0.1|
73967263|NCT01889199|147471676|OTHER||Mean Difference (Final Values)|1.12||||0.004|TWO_SIDED|||||a priori threshold p\<0.05|t-test, 2 sided|||Only PCOS women were randomized to flutamide versus placebo; controls were not randomized A sample size of 11 per group (PCOS women versus controls) provided adequate power (approximately 80%) to detect effect sizes as small as 1.25 using a two-sample t-test (alpha=0.05, 2 tailed). A sample size of 5 per group (flutamide-treated versus placebo-treated PCOS women) also gave adequate power (approximately 80%) to detect effect sizes as small as 2 using a two-sample t-test (alpha=0.05, 2 tailed).||||0.004
73967264|NCT01889199|147471677|OTHER||Mean Difference (Net)|0.024|||||TWO_SIDED|||||||||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||
73967265|NCT01889199|147471679|OTHER||Mean Difference (Net)|0.04||||0.04|TWO_SIDED||||||t-test, 2 sided|||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||0.040
73920480|NCT02879305|147368981|SUPERIORITY||Difference in response rate|3.5||||0.0367|TWO_SIDED|95.0|-0.1|7.1|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test adjusted for dialysis type, and region was used to compare the number of responders between the treatment groups.|||7.1|-0.1|0.0367
73920481|NCT02879305|147368982|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|1.06|||||TWO_SIDED|95.0|0.0|3.86|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-rhEPO) and associated two-sided asymptotic 95% CI is presented.|||3.86|0.00|
73920482|NCT02879305|147368983|SUPERIORITY||Probability|0.52||||0.0805|TWO_SIDED|95.0|0.49|0.54|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.54|0.49|0.0805
73920483|NCT02879305|147368984|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|2.18|||||TWO_SIDED|95.0|0.28|4.05|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-rhEPO) and associated two-sided asymptotic 95% CI is presented.|||4.05|0.28|
73920484|NCT02879305|147368985|SUPERIORITY||Probability|0.53||||0.0139|TWO_SIDED|95.0|0.5|0.55|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.55|0.50|0.0139
73920485|NCT02879305|147368986|SUPERIORITY||LS mean difference|0.33||||0.6551|TWO_SIDED|95.0|-1.28|1.94|||MMRM||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||1.94|-1.28|0.6551
73920486|NCT02879305|147368986|SUPERIORITY||LS mean difference|-0.46||||0.1586|TWO_SIDED|95.0|-1.36|0.44|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||0.44|-1.36|0.1586
73920487|NCT02879305|147368986|SUPERIORITY||LS mean difference|-0.18||||0.3646|TWO_SIDED|95.0|-1.2|0.84|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||0.84|-1.20|0.3646
73967266|NCT01889199|147471680|OTHER|||||||0.034|||||||t-test, 2 sided|||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||0.034
73967267|NCT00220740|147471697|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The primary efficacy endpoint was the comparison of the Responder rates in the ITT population. Treatment group differences were tested by a Chi-square test. Subjects who did not complete the 24 week Efficacy Period and entered Rescue treatment with the alternative treatment were counted as Nonresponders.||||<0.001
73967268|NCT00220740|147471698|SUPERIORITY_OR_OTHER|||||||0.542|TWO_SIDED||||||ANCOVA|||||||0.542
73920488|NCT02879305|147368987|SUPERIORITY||LS mean difference|0.0||||0.5012|TWO_SIDED|95.0|-1.54|1.54|||ANCOVA||For SBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.54|-1.54|0.5012
73920489|NCT02879305|147368987|SUPERIORITY||LS mean difference|0.45||||0.8451|TWO_SIDED|95.0|-0.42|1.31|||ANCOVA||For DBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.31|-0.42|0.8451
73920490|NCT02879305|147368987|SUPERIORITY||LS mean difference|0.31||||0.7312|TWO_SIDED|95.0|-0.67|1.28|||ANCOVA||For MAP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.28|-0.67|0.7312
73920491|NCT02879305|147368988|SUPERIORITY||Ratio of exacerbation rate|1.0||||0.529|TWO_SIDED|95.0|0.91|1.11|||Negative binomial model||Ratio of model estimated exacerbation rates and CIs were estimated using a negative binomial model for the treatment group comparison.|||1.11|0.91|0.5290
73920492|NCT02879305|147368990|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5772|TWO_SIDED|95.0|0.71|1.52|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, dialysis type and region.|||1.52|0.71|0.5772
73920493|NCT02879305|147368991|SUPERIORITY||LS mean difference|0.29||||0.162|TWO_SIDED|95.0|-0.29|0.86|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and the model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.86|-0.29|0.1620
73920494|NCT02879305|147368991|SUPERIORITY||LS mean difference|0.61||||0.018|TWO_SIDED|95.0|0.04|1.18|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and the model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.18|0.04|0.0180
73920495|NCT02879305|147368991|SUPERIORITY||LS mean difference|0.33||||0.153|TWO_SIDED|95.0|-0.31|0.97|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and the model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.97|-0.31|0.1530
73920496|NCT02879305|147368991|SUPERIORITY||LS mean difference|0.53||||0.0686|TWO_SIDED|95.0|-0.17|1.22|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and the model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.22|-0.17|0.0686
73967269|NCT00220740|147471699|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Dominant hand||||<0.001
73967270|NCT00220740|147471699|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||Non-dominant hand||||0.005
73967271|NCT03964350|147471749|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
73967272|NCT04402489|147471769|SUPERIORITY||Least Square Mean Difference vs Placebo|9.8|STANDARD_ERROR_OF_MEAN|14.35||0.496|TWO_SIDED|95.0|-18.52|38.12|||Mixed-effect model for repeated measures|||Change from BL at Week 26 (DBT EOT) - lower dose||38.12|-18.52|0.496
73967273|NCT04402489|147471769|SUPERIORITY||Least Square Mean Difference vs Placebo|22.7|STANDARD_ERROR_OF_MEAN|14.38||0.116|TWO_SIDED|95.0|-5.68|51.09|||Mixed-effect model for repeated measures|||Change from BL at Week 26 (DBT EOT) - higher dose||51.09|-5.68|0.116
73967274|NCT04402489|147471770|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.84|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.23|-0.44|||Mixed-effect model for repeated measures|||||-0.44|-1.23|< 0.001
73920497|NCT02879305|147368992|SUPERIORITY||LS mean difference|-0.17||||0.6807|TWO_SIDED|95.0|-0.88|0.54|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and the model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.54|-0.88|0.6807
73920498|NCT02879305|147368992|SUPERIORITY||LS mean difference|0.17||||0.3256|TWO_SIDED|95.0|-0.57|0.91|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and the model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.91|-0.57|0.3256
73967275|NCT04402489|147471770|SUPERIORITY||Least Square Mean Difference vs Placebo|-1.43|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.83|-1.03|||Mixed-effect model for repeated measures|||||-1.03|-1.83|< 0.001
73967276|NCT04402489|147471771|SUPERIORITY|Negative binomial regression model with log link was used.|Incident rate ratio|0.76||||0.199|TWO_SIDED|95.0|0.49|1.16|||Refer to comments below:|Negative binomial regression model with log link was used for other method.||||1.16|0.49|0.199
73920499|NCT02879305|147368992|SUPERIORITY||LS mean difference|-0.01||||0.5144|TWO_SIDED|95.0|-0.81|0.78|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and the model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.78|-0.81|0.5144
73967277|NCT04402489|147471771|SUPERIORITY|Negative binomial regression model with log link was used.|Incident rate ratio|0.55||||0.006|TWO_SIDED|95.0|0.36|0.84|||Refer to comments below:|Negative binomial regression model with log link was used for other method.||||0.84|0.36|0.006
73967278|NCT04402489|147471772|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.15|STANDARD_ERROR_OF_MEAN|0.24||0.55|TWO_SIDED|95.0|-0.62|0.33|||mixed-effect model for repeated measures|||||0.33|-0.62|0.55
73967279|NCT04402489|147471772|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.343|TWO_SIDED|95.0|-0.72|0.25|||mixed-effect model for repeated measures|||||0.25|-0.72|0.343
74028050|NCT01380093|147610062|SUPERIORITY_OR_OTHER||LS Mean Difference|324.6|||<|0.0001|TWO_SIDED|95.0|287.7|361.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||361.5|287.7|<0.0001
74028051|NCT01380093|147610063|SUPERIORITY_OR_OTHER||LS Mean Difference|-253.0|||<|0.0001|TWO_SIDED|95.0|-301.5|-204.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-204.5|-301.5|<0.0001
73920500|NCT02879305|147368992|SUPERIORITY||LS mean difference|-0.6||||0.912|TWO_SIDED|95.0|-1.47|0.27|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and the model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.27|-1.47|0.9120
73967280|NCT04402489|147471773|SUPERIORITY||Odds Ratio (OR)|0.805||||0.642|TWO_SIDED|95.0|0.323|2.007|||Regression, Logistic|||||2.007|0.323|0.642
74028052|NCT01380093|147610063|SUPERIORITY_OR_OTHER||LS Mean Difference|151.9|||<|0.0001|TWO_SIDED|95.0|103.5|200.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||200.2|103.5|<0.0001
73920501|NCT02879305|147368993|SUPERIORITY||LS mean difference|-0.25||||0.7432|TWO_SIDED|95.0|-0.99|0.5|||MMRM||Bodily pain,Week8: Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.50|-0.99|0.7432
73920502|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.58||||0.0631|TWO_SIDED|95.0|-0.16|1.33|||MMRM||Bodily pain,Week12: Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.33|-0.16|0.0631
73967281|NCT04402489|147471773|SUPERIORITY||Odds Ratio (OR)|1.412||||0.431|TWO_SIDED|95.0|0.598|3.336|||Regression, Logistic|||||3.336|0.598|0.431
73967282|NCT04402489|147471774|SUPERIORITY||Least Square Mean Difference vs Placebo|0.87|STANDARD_ERROR_OF_MEAN|0.48||0.072|TWO_SIDED|95.0|-0.08|1.82|||mixed-effect model for repeated measures|||||1.82|-0.08|0.072
73967283|NCT04402489|147471774|SUPERIORITY||Least Square Mean Difference vs Placebo|0.56|STANDARD_ERROR_OF_MEAN|0.48||0.252|TWO_SIDED|95.0|-0.4|1.51|||mixed-effect model for repeated measures|||||1.51|-0.4|0.252
73967284|NCT03328702|147471795|SUPERIORITY|Repeated measures ANOVA|Mean Difference (Net)|0.01|||<|0.05|TWO_SIDED|||||Repeated measures ANOVA, N=4|ANOVA|Repeated measures ANOVA||The null hypothesis is that there is no difference in total pharyngeal transit time with the use of CPAP||||<0.05
73967285|NCT04833777|147471796|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73967286|NCT04833777|147471797|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73967287|NCT04833777|147471798|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73967288|NCT04833777|147471799|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73967289|NCT04833777|147471800|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73967290|NCT04833777|147471801|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73967291|NCT04833777|147471802|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73967292|NCT04833777|147471803|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73967293|NCT04833777|147471804|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73967294|NCT04833777|147471805|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73967295|NCT04833777|147471806|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73967296|NCT04833777|147471807|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73967297|NCT04833777|147471808|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73967298|NCT04833777|147471809|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73967299|NCT04833777|147471811|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73967300|NCT04833777|147471812|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73967301|NCT03854578|147471835|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MontgomeryÅsberg Depression Rating Scale (MADRS) ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.0105|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||-0.03|-0.14|0.0105
73967302|NCT03854578|147471835|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.0134|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||-0.03|-0.14|0.0134
73967303|NCT03854578|147471835|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3495|TWO_SIDED|90.0|-0.08|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.08|0.3495
73967304|NCT03854578|147471835|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7008|TWO_SIDED|90.0|-0.07|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex right||0.04|-0.07|0.7008
73967305|NCT03854578|147471835|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6635|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.05|-0.08|0.6635
73967306|NCT03854578|147471835|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8792|TWO_SIDED|90.0|-0.09|0.07|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.07|-0.09|0.8792
73967307|NCT03854578|147471835|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.04||0.0419|TWO_SIDED|90.0|-0.15|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||-0.02|-0.15|0.0419
73967308|NCT03854578|147471835|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1658|TWO_SIDED|90.0|-0.12|0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.01|-0.12|0.1658
73967309|NCT03854578|147471835|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6673|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD Signal % change/ Amygdala Left||0.05|-0.08|0.6673
73967310|NCT03854578|147471835|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0778|TWO_SIDED|90.0|-0.14|-0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD Signal % Change/ Amygdala Right||-0.01|-0.14|0.0778
73967311|NCT03854578|147471835|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3258|TWO_SIDED|90.0|-0.08|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.08|0.3258
73967312|NCT03854578|147471835|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.5954|TWO_SIDED|90.0|-0.07|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||0.04|-0.07|0.5954
73967313|NCT03854578|147471835|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5911|TWO_SIDED|90.0|-0.08|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.04|-0.08|0.5911
74088476|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat 5+ servings of fruits and vegetables."||||0.59
73967314|NCT03854578|147471835|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8283|TWO_SIDED|90.0|-0.11|0.08|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.08|-0.11|0.8283
73967315|NCT03854578|147471835|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1797|TWO_SIDED|90.0|-0.12|0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||0.01|-0.12|0.1797
73920503|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.04||||0.4604|TWO_SIDED|95.0|-0.79|0.87|||MMRM||Bodily pain,Week28: Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.87|-0.79|0.4604
73920504|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.28||||0.2688|TWO_SIDED|95.0|-0.6|1.15|||MMRM||Bodily pain,Week52: Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.15|-0.60|0.2688
73920505|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.26||||0.1918|TWO_SIDED|95.0|-0.32|0.84|||MMRM||General health,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.84|-0.32|0.1918
73920506|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.45||||0.0677|TWO_SIDED|95.0|-0.14|1.04|||MMRM||General health,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.04|-0.14|0.0677
73920507|NCT02879305|147368993|SUPERIORITY||LS mean difference|-0.33||||0.8386|TWO_SIDED|95.0|-0.98|0.32|||MMRM||General health,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.32|-0.98|0.8386
73920508|NCT02879305|147368993|SUPERIORITY||LS mean difference|-0.29||||0.7928|TWO_SIDED|95.0|-0.99|0.41|||MMRM||General health,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.41|-0.99|0.7928
73920509|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.04||||0.4537|TWO_SIDED|95.0|-0.63|0.71|||MMRM||Mental health,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.71|-0.63|0.4537
73920510|NCT02879305|147368993|SUPERIORITY||LS mean difference|-0.05||||0.5548|TWO_SIDED|95.0|-0.74|0.65|||MMRM||Mental health,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.65|-0.74|0.5548
73967316|NCT03854578|147471835|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5772|TWO_SIDED|90.0|-0.08|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.04|-0.08|0.5772
73920511|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.13||||0.3626|TWO_SIDED|95.0|-0.61|0.88|||MMRM||Mental health,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.88|-0.61|0.3626
73920512|NCT02879305|147368993|SUPERIORITY||LS mean difference|-0.81||||0.9721|TWO_SIDED|95.0|-1.64|0.02|||MMRM||Mental health,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.02|-1.64|0.9721
73967317|NCT03854578|147471836|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0147|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||-0.03|-0.14|0.0147
73920513|NCT02879305|147368993|SUPERIORITY||LS mean difference|-0.09||||0.5789|TWO_SIDED|95.0|-0.96|0.78|||MMRM||Role-emotional,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.78|-0.96|0.5789
73920514|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.37||||0.2054|TWO_SIDED|95.0|-0.51|1.24|||MMRM||Role-emotional,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.24|-0.51|0.2054
73920515|NCT02879305|147368993|SUPERIORITY||LS mean difference|-0.05||||0.5389|TWO_SIDED|95.0|-0.98|0.89|||MMRM||Role-emotional,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.89|-0.98|0.5389
73920516|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.09||||0.4289|TWO_SIDED|95.0|-0.91|1.09|||MMRM||Role-emotional,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.09|-0.91|0.4289
73967318|NCT03854578|147471836|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.048|TWO_SIDED|90.0|-0.13|-0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||-0.01|-0.13|0.0480
73920517|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.08||||0.4096|TWO_SIDED|95.0|-0.6|0.75|||MMRM||Role-physical,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.75|-0.60|0.4096
73920518|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.4||||0.1196|TWO_SIDED|95.0|-0.27|1.07|||MMRM||Role-physical,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.07|-0.27|0.1196
73920519|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.3||||0.2093|TWO_SIDED|95.0|-0.42|1.01|||MMRM||Role-physical,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.01|-0.42|0.2093
73920520|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.39||||0.1674|TWO_SIDED|95.0|-0.4|1.19|||MMRM||Role-physical,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.19|-0.40|0.1674
73920521|NCT02879305|147368993|SUPERIORITY||LS mean difference|-0.14||||0.6585|TWO_SIDED|95.0|-0.82|0.54|||MMRM||Social fun, Week 8: Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.54|-0.82|0.6585
73920522|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.69||||0.0293|TWO_SIDED|95.0|-0.03|1.4|||MMRM||Social fun, Week 12: Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.40|-0.03|0.0293
73920523|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.33||||0.2057|TWO_SIDED|95.0|-0.45|1.11|||MMRM||Social fun, Week 28: Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.11|-0.45|0.2057
73920524|NCT02879305|147368993|SUPERIORITY||LS mean difference|0.02||||0.4849|TWO_SIDED|95.0|-0.86|0.9|||MMRM||Social fun, Week 52: Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.90|-0.86|0.4849
73967319|NCT03854578|147471836|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.0294|TWO_SIDED|90.0|-0.12|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||-0.02|-0.12|0.0294
73967320|NCT03854578|147471836|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.0359|TWO_SIDED|90.0|-0.13|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||-0.02|-0.13|0.0359
73967321|NCT03854578|147471836|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.0022|TWO_SIDED|90.0|-0.19|-0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||-0.06|-0.19|0.0022
73967322|NCT03854578|147471836|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.104|TWO_SIDED|90.0|-0.15|0.0|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.00|-0.15|0.1040
74028053|NCT01380093|147610063|SUPERIORITY_OR_OTHER||LS Mean Difference|404.9|||<|0.0001|TWO_SIDED|95.0|356.4|453.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||453.3|356.4|<0.0001
73920525|NCT02879305|147368994|SUPERIORITY||LS mean difference|0.03||||0.4621|TWO_SIDED|95.0|-0.58|0.64|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.64|-0.58|0.4621
73920526|NCT02879305|147368994|SUPERIORITY||LS mean difference|0.35||||0.1439|TWO_SIDED|95.0|-0.29|0.98|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.98|-0.29|0.1439
73920527|NCT02879305|147368994|SUPERIORITY||LS mean difference|0.24||||0.2392|TWO_SIDED|95.0|-0.43|0.92|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.92|-0.43|0.2392
73920528|NCT02879305|147368994|SUPERIORITY||LS mean difference|-0.15||||0.6545|TWO_SIDED|95.0|-0.9|0.6|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.60|-0.90|0.6545
73920529|NCT02879305|147368995|SUPERIORITY||LS mean difference|0.64||||0.029|TWO_SIDED|95.0|-0.02|1.31|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.31|-0.02|0.0290
73920530|NCT02879305|147368995|SUPERIORITY||LS mean difference|0.56||||0.0509|TWO_SIDED|95.0|-0.11|1.24|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.24|-0.11|0.0509
73920531|NCT02879305|147368995|SUPERIORITY||LS mean difference|0.77||||0.0237|TWO_SIDED|95.0|0.01|1.53|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.53|0.01|0.0237
73967323|NCT03854578|147471836|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.12|STANDARD_ERROR_OF_MEAN|0.04||0.0022|TWO_SIDED|90.0|-0.18|-0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||-0.06|-0.18|0.0022
73967324|NCT03854578|147471836|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.04||0.0331|TWO_SIDED|90.0|-0.14|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||-0.02|-0.14|0.0331
73967325|NCT03854578|147471836|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.2149|TWO_SIDED|90.0|-0.11|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||0.02|-0.11|0.2149
73967326|NCT03854578|147471836|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6896|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||0.05|-0.08|0.6896
74028054|NCT01380093|147610064|SUPERIORITY_OR_OTHER||LS Mean Difference|-306.8|||<|0.0001|TWO_SIDED|95.0|-370.9|-242.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-242.6|-370.9|<0.0001
74028055|NCT01380093|147610064|SUPERIORITY_OR_OTHER||LS Mean Difference|168.6|||<|0.0001|TWO_SIDED|95.0|104.7|232.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||232.6|104.7|<0.0001
74028056|NCT01380093|147610064|SUPERIORITY_OR_OTHER||LS Mean Difference|475.4|||<|0.0001|TWO_SIDED|95.0|411.3|539.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||539.6|411.3|<0.0001
74028057|NCT01380093|147610065|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.5607|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.0|-0.6|0.5607
73920532|NCT02879305|147368995|SUPERIORITY||LS mean difference|0.58||||0.0828|TWO_SIDED|95.0|-0.24|1.39|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.39|-0.24|0.0828
74028058|NCT01380093|147610065|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.2|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.2|<0.0001
74028059|NCT01380093|147610065|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|||<|0.0001|TWO_SIDED|95.0|1.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.6|1.0|<0.0001
74028060|NCT01380093|147610066|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3|||<|0.0001|TWO_SIDED|95.0|-20.3|-10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-10.3|-20.3|<0.0001
74028061|NCT01380093|147610066|SUPERIORITY_OR_OTHER||LS Mean Difference|11.2|||<|0.0001|TWO_SIDED|95.0|6.3|16.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||16.2|6.3|<0.0001
74028062|NCT01380093|147610066|SUPERIORITY_OR_OTHER||LS Mean Difference|26.5|||<|0.0001|TWO_SIDED|95.0|21.5|31.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||31.5|21.5|<0.0001
74028063|NCT01380093|147610067|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.7|||<|0.0001|TWO_SIDED|95.0|-59.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.9|-59.5|<0.0001
73920533|NCT02879305|147368996|SUPERIORITY||LS mean difference|0.0003||||0.4939|TWO_SIDED|95.0|-0.0326|0.0331|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.0331|-0.0326|0.4939
74028064|NCT01380093|147610067|SUPERIORITY_OR_OTHER||LS Mean Difference|28.3|||<|0.0001|TWO_SIDED|95.0|16.5|40.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||40.1|16.5|<0.0001
74028065|NCT01380093|147610067|SUPERIORITY_OR_OTHER||LS Mean Difference|76.0|||<|0.0001|TWO_SIDED|95.0|64.2|87.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||87.8|64.2|<0.0001
74028066|NCT01380093|147610068|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.3|||<|0.0001|TWO_SIDED|95.0|-132.9|-85.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-85.6|-132.9|<0.0001
73920534|NCT02879305|147368997|SUPERIORITY||LS mean difference|-1.8||||0.9292|TWO_SIDED|95.0|-4.2|0.6|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.6|-4.2|0.9292
73920535|NCT02879305|147368998|SUPERIORITY||LS mean difference|-0.06||||0.0428|TWO_SIDED|95.0|-0.13|0.01|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.01|-0.13|0.0428
73920536|NCT02879305|147368998|SUPERIORITY||LS mean difference|-0.04||||0.1155|TWO_SIDED|95.0|-0.11|0.03|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.11|0.1155
74028067|NCT01380093|147610068|SUPERIORITY_OR_OTHER||LS Mean Difference|67.0|||<|0.0001|TWO_SIDED|95.0|43.5|90.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||90.6|43.5|<0.0001
74028068|NCT01380093|147610068|SUPERIORITY_OR_OTHER||LS Mean Difference|176.3|||<|0.0001|TWO_SIDED|95.0|152.6|199.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||199.9|152.6|<0.0001
74028069|NCT01380093|147610069|SUPERIORITY_OR_OTHER||LS Mean Difference|-190.8|||<|0.0001|TWO_SIDED|95.0|-234.2|-147.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-147.3|-234.2|<0.0001
74028070|NCT01380093|147610069|SUPERIORITY_OR_OTHER||LS Mean Difference|134.7|||<|0.0001|TWO_SIDED|95.0|91.5|178.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||178.0|91.5|<0.0001
74028071|NCT01380093|147610069|SUPERIORITY_OR_OTHER||LS Mean Difference|325.5|||<|0.0001|TWO_SIDED|95.0|282.1|368.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||368.9|282.1|<0.0001
74088477|NCT01221090|147730269|SUPERIORITY_OR_OTHER||||||<|0.004||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat high-fat foods."||||<0.004
74088478|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat packaged foods (e.g., sweets and desserts)."||||0.66
73920537|NCT02879305|147368998|SUPERIORITY||LS mean difference|-0.04||||0.1426|TWO_SIDED|95.0|-0.12|0.03|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.12|0.1426
73920538|NCT02879305|147368998|SUPERIORITY||LS mean difference|-0.05||||0.1152|TWO_SIDED|95.0|-0.13|0.03|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.13|0.1152
73920539|NCT04615923|147369023|SUPERIORITY||Disease Rate Ratio|0.99|STANDARD_DEVIATION|0.103|||TWO_SIDED|95.0|0.801|1.207||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. Pridopidine slowed progression) was (0.5475). NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by verdiperstat relative to placebo.Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.207|0.801|
73920540|NCT04615923|147369025|SUPERIORITY||Median Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.334||0.78|TWO_SIDED|95.0|-0.75|0.57|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.57|-0.75|0.78
73920541|NCT04615923|147369026|SUPERIORITY||Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.217||0.6594|TWO_SIDED|95.0|-0.33|0.52|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.52|-0.33|0.6594
73920542|NCT04615923|147369027|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|1.745||0.7918|TWO_SIDED|95.0|-3.89|2.96|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||2.96|-3.89|0.7918
73920543|NCT04615923|147369028|SUPERIORITY||Median Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.426||0.9903|TWO_SIDED|95.0|-0.83|0.84|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.84|-0.83|0.9903
73967327|NCT03854578|147471836|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4769|TWO_SIDED|90.0|-0.06|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.06|0.4769
73967328|NCT03854578|147471836|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.768|TWO_SIDED|90.0|-0.07|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||0.05|-0.07|0.7680
73967329|NCT03854578|147471836|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.7997|TWO_SIDED|90.0|-0.08|0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.06|-0.08|0.7997
73967330|NCT03854578|147471836|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.8334|TWO_SIDED|90.0|-0.08|0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.06|-0.08|0.8334
73920544|NCT04615923|147369029|SUPERIORITY|Analysis performed using interval-censored survival analysis. This type of model accommodates interval censoring between ALSFRS-R assessments|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.69|1.27|||Regression, Cox|Interval censored cox model adjusted for time since symptom onset, pre-baseline change in ALSFRS-R, baseline use of edaravone, riluzole, and neudexta||||1.27|0.69|
73920545|NCT04615923|147369030|SUPERIORITY||Mean Difference (Net)|-1.78|STANDARD_ERROR_OF_MEAN|3.285||0.5888|TWO_SIDED|95.0|-8.23|4.67|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||4.67|-8.23|0.5888
73920546|NCT04615923|147369031|SUPERIORITY|||||||0.969|||||||Log Rank|||||||0.9690
73920547|NCT02282020|147369032|SUPERIORITY||Odds Ratio (OR)|2.53||||0.002|TWO_SIDED|95.0|1.4|4.58|||Regression, Logistic|Model includes a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months)|An odds ratio \>1 favours the olaparib arm|||4.58|1.40|0.002
73920548|NCT02282020|147369033|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.013|TWO_SIDED|95.0|0.43|0.91||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.91|0.43|0.013
73920549|NCT02282020|147369034|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.229|TWO_SIDED|95.0|0.56|1.15||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.15|0.56|0.229
73967331|NCT03854578|147471836|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.7402|TWO_SIDED|90.0|-0.07|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||0.05|-0.07|0.7402
73967332|NCT03854578|147471836|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.812|TWO_SIDED|90.0|-0.06|0.08|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.08|-0.06|0.8120
73967333|NCT03648840|147471843|OTHER||||||<|0.2|||||||t-test, 2 sided|||2-tailed, unpaired T-test||||<0.2
73967334|NCT05063994|147471852|NON_INFERIORITY|Non-inferiority of Chronocort to Cortef was declared if the 95% CI for the difference in biochemical response rates between the 2 treatment arms (Chronocort minus Cortef) was wholly above minus 15 percentage points.|Treatment Difference|25.7|STANDARD_ERROR_OF_MEAN|11.82||0.0003|TWO_SIDED|95.0|2.5|48.9||One-sided non-inferiority. The Ge et al (2011) method was used to calculate the estimate, standard error, confidence interval and P-value for the treatment difference from the results of a logistic regression analysis.|Regression, Logistic|||||48.9|2.5|0.0003
74028072|NCT01380093|147610070|SUPERIORITY_OR_OTHER||LS Mean Difference|-244.9|||<|0.0001|TWO_SIDED|95.0|-302.0|-187.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-187.7|-302.0|<0.0001
74028073|NCT01380093|147610070|SUPERIORITY_OR_OTHER||LS Mean Difference|166.5|||<|0.0001|TWO_SIDED|95.0|109.5|223.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||223.5|109.5|<0.0001
73920550|NCT02282020|147369035|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.714|TWO_SIDED|95.0|0.76|1.49||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.49|0.76|0.714
73920551|NCT02282020|147369036|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.005|TWO_SIDED|95.0|0.41|0.85||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \<1 favours the olaparib arm|||0.85|0.41|0.005
73920552|NCT02282020|147369037|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.35|0.69||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.69|0.35|<0.001
73920553|NCT02282020|147369038|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.089|TWO_SIDED|95.0|0.53|1.05||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.05|0.53|0.089
73920554|NCT02282020|147369039|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.001|TWO_SIDED|95.0|0.14|0.29||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.29|0.14|<0.001
73920555|NCT02282020|147369042|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.108|TWO_SIDED|95.0|-0.5|5.5|||Mixed Models Analysis|Model includes factors for patient, treatment, visit, treatment by visit interaction, baseline TOI score and baseline TOI score by visit interaction.||||5.5|-0.5|0.108
73920556|NCT02282020|147369043|SUPERIORITY||Odds Ratio (OR)|2.24||||0.092|TWO_SIDED|95.0|0.88|6.86||Estimated from an unadjusted logistic regression model|Regression, Logistic||An odds ratio \> 1 favours the olaparib arm|||6.86|0.88|0.092
73920557|NCT02282020|147369044|SUPERIORITY||Odds Ratio (OR)|2.4||||0.004|TWO_SIDED|95.0|1.32|4.39||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Regression, Logistic||An odds ratio \> 1 favours the olaparib arm|||4.39|1.32|0.004
73920558|NCT02282020|147369045|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.014|TWO_SIDED|95.0|0.42|0.91||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.91|0.42|0.014
73920559|NCT02282020|147369046|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.213|TWO_SIDED|95.0|0.56|1.14||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.14|0.56|0.213
73920560|NCT02282020|147369047|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.699|TWO_SIDED|95.0|0.76|1.51||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.51|0.76|0.699
73920561|NCT02282020|147369048|SUPERIORITY||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.12|0.27||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.27|0.12|<0.001
73920562|NCT02282020|147369049|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.66||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.66|0.33|<0.001
73920563|NCT02282020|147369050|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.055|TWO_SIDED|95.0|0.51|1.01||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.01|0.51|0.055
73920564|NCT04309656|147369061|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|85.85||||0.0001|TWO_SIDED|90.0|81.21|90.75|||ANOVA|||||90.75|81.21|0.0001
73920565|NCT04309656|147369061|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|92.99||||0.3001|TWO_SIDED|90.0|82.65|104.62|||ANOVA|||||104.62|82.65|0.3001
74028074|NCT01380093|147610070|SUPERIORITY_OR_OTHER||LS Mean Difference|411.4|||<|0.0001|TWO_SIDED|95.0|354.3|468.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||468.6|354.3|<0.0001
73920566|NCT04309656|147369062|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|100.6||||0.6686|TWO_SIDED|90.0|98.23|103.03|||ANOVA|||||103.03|98.23|0.6686
73920567|NCT04309656|147369062|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|89.7||||0.0745|TWO_SIDED|90.0|81.2|99.1|||ANOVA|||||99.10|81.20|0.0745
73920568|NCT04309656|147369063|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|101.03||||0.4683|TWO_SIDED|90.0|98.65|103.47|||ANOVA|||||103.47|98.65|0.4683
73920569|NCT04309656|147369063|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|89.63||||0.0734|TWO_SIDED|90.0|81.1|99.05|||ANOVA|||||99.05|81.10|0.0734
73920570|NCT00303498|147369068|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|43.0||||0.0302|||||||ANCOVA|Change at Week 24: P-value was obtained from the non-parametric analysis of covariance (ANCOVA) controlling for baseline treadmill exercise time.||The median of the treatment difference was calculated using the Hodges-Lehmann estimator.||||0.0302
73920571|NCT00303498|147369069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5||||0.495|||||||ANCOVA|Change at Week 24: P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.4950
73920572|NCT00303498|147369070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.6||||0.3874|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||Change at Week 24 for PLAX 2D mode||||0.3874
73920573|NCT00303498|147369070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.8||||0.7038|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||Change at Week 24 for PSAX M-mode||||0.7038
73920574|NCT00303498|147369071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.9||||0.8998|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.8998
73967335|NCT05063994|147471853|SUPERIORITY|Superiority of Chronocort to Cortef with respect to the dose response after 28 weeks of randomized treatment was declared if the two-sided 95% CI for the difference in response rates between the 2 treatment arms (Chronocort minus Cortef) was wholly above zero, provided that non-inferiority of Chronocort to Cortef with respect to the biochemical response had been declared under the primary efficacy objective.|Treatment Difference|25.3|STANDARD_ERROR_OF_MEAN|11.24||0.012|TWO_SIDED|95.0|3.3|47.3||One-sided superiority. The Ge et al (2011) method was used to calculate the estimate, standard error, confidence interval and P-value for the treatment difference from the results of a logistic regression analysis.|Regression, Logistic|||||47.3|3.3|0.012
73967336|NCT05063994|147471854|SUPERIORITY|Superiority of Chronocort to Cortef (with respect to the total daily dose after 28 weeks of randomized treatment) was declared if the two-sided 95% CI for the difference in means between the 2 treatment arms (Chronocort minus Cortef) was wholly below zero, provided that non-inferiority of Chronocort to Cortef in terms of biochemical response had been declared under the primary efficacy objective, and superiority of Chronocort to Cortef in terms of dose response has been declared.|Treatment Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.66||0.0005|TWO_SIDED|95.0|-9.2|-2.5||One-sided superiority.|MMRM|||||-2.5|-9.2|0.0005
73967337|NCT03703700|147471867|OTHER||Risk Ratio (RR)|1.23||||0.042|TWO_SIDED|95.0|1.01|1.5|||Chi-squared|||||1.50|1.01|0.042
73967338|NCT03703700|147471868|OTHER|||||||0.781|||||||Wilcoxon (Mann-Whitney)|||||||0.781
73967339|NCT03703700|147471869|OTHER|||||||0.609|||||||Wilcoxon (Mann-Whitney)|||||||0.609
73967340|NCT03703700|147471870|OTHER|||||||0.528|||||||Wilcoxon (Mann-Whitney)|||||||0.528
73967341|NCT03703700|147471871|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.880
73967342|NCT03703700|147471872|OTHER|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||||||0.289
73967343|NCT03703700|147471873|OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.860
73967344|NCT03703700|147471874|OTHER|||||||0.163|||||||Wilcoxon (Mann-Whitney)|||||||0.163
73920575|NCT00303498|147369072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.7||||0.7245|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.7245
73967345|NCT03703700|147471875|OTHER|||||||0.197|||||||Wilcoxon (Mann-Whitney)|||||||0.197
73967346|NCT03703700|147471876|OTHER|||||||0.178|||||||Wilcoxon (Mann-Whitney)|||||||0.178
73920576|NCT00303498|147369073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5||||0.8649|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.8649
73920577|NCT00303498|147369074|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5909||||||The statistical analysis (P value) was performed on the composite change for all categories.|Cochran-Mantel-Haenszel|||Change at Week 24||||0.5909
73967347|NCT03703700|147471877|OTHER|||||||0.549|||||||Wilcoxon (Mann-Whitney)|||||||0.549
73967348|NCT03703700|147471878|OTHER||Risk Ratio (RR)|1.19||||0.035|TWO_SIDED|95.0|1.01|1.4|||Chi-squared|||||1.40|1.01|0.035
73967349|NCT03703700|147471879|OTHER||Risk Ratio (RR)|1.18||||0.034|TWO_SIDED|95.0|1.01|1.37|||Chi-squared|||||1.37|1.01|0.034
73967350|NCT03703700|147471880|OTHER||Risk Ratio (RR)|1.22||||0.022|TWO_SIDED|95.0|1.03|1.45|||Chi-squared|||||1.45|1.03|0.022
73967351|NCT03703700|147471881|OTHER||Risk Ratio (RR)|0.94||||0.707|TWO_SIDED|95.0|0.68|1.3|||Chi-squared|||||1.30|0.68|0.707
73920578|NCT01493570|147369096|OTHER||Ratio CSF to Plasma in %|28.31||||1|TWO_SIDED|90.0|25.418|31.532||p-value for ratio outside interval 80% - 125%|ANOVA||Intra Individual geometric coefficient of variation (gCV \[%\]) = 17.50 .|Dose-adjusted CSF to plasma ratio for Cmax. The Analysis of Variance (ANOVA) model was used with 'subject nested within treatment' considered as random effect.||31.532|25.418|1.0000
73967352|NCT03703700|147471882|OTHER||Risk Ratio (RR)|0.97||||0.878|TWO_SIDED|95.0|0.66|1.42|||Chi-squared|||||1.42|0.66|0.878
73967353|NCT03703700|147471883|OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Singleton||||0.564
73967354|NCT03703700|147471883|OTHER|||||||0.417|||||||Wilcoxon (Mann-Whitney)|||Twin||||0.417
73967355|NCT03703700|147471884|OTHER|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||Singleton||||0.985
73967356|NCT03703700|147471884|OTHER|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Twin||||0.157
73967357|NCT03703700|147471885|OTHER||Risk Ratio (RR)|1.07||||0.789|TWO_SIDED|95.0|0.65|1.78|||Chi-squared|||||1.78|0.65|0.789
73967358|NCT03703700|147471886|OTHER||Risk Ratio (RR)|1.09||||0.769|TWO_SIDED|95.0|0.61|1.94|||Chi-squared|||||1.94|0.61|0.769
73967359|NCT03703700|147471887|OTHER||Risk Ratio (RR)|0.41||||0.59|TWO_SIDED|95.0|0.04|4.45|||Fisher Exact|||||4.45|0.04|0.590
73967360|NCT03703700|147471888|OTHER||Risk Ratio (RR)|2.04||||0.465|TWO_SIDED|95.0|0.4|10.39|||Fisher Exact|||||10.39|0.40|0.465
73967361|NCT04490915|147471950|SUPERIORITY||LS Mean Difference|-17.022|STANDARD_ERROR_OF_MEAN|3.433|<|0.0001|TWO_SIDED|95.0|-23.802|-10.243|||ANCOVA||LS Mean Difference of Crinecerfont - Placebo|||-10.243|-23.802|<0.0001
73967362|NCT03149315|147471962|SUPERIORITY|Values for grouped data were reported as mean ± SD and were calculated using Graphpad Prism 7 software (La Jolla, CA), which was also used for generating figures and for statistical analyses. Changes in skin test area (wheal and flare) were analyzed at each time point (after 2 doses, 4 doses, etc) using Friedman tests for grouped analysis and Wilcoxon signed rank tests between pairs.|||||<|0.0001||||||The above p value reflects the statistical analysis of skin test area between baseline and 2 doses of ibrutinib.|Wilcoxon (Mann-Whitney)|Changes in skin test area at each time point were analyzed using Friedman tests for grouped analysis and Wilcoxon signed rank tests between pairs.||||||<0.0001
73967363|NCT03149315|147471963|SUPERIORITY|Changes in BAT were analyzed at each time point (after 2 doses, 4 doses, etc) using repeated measures ANOVA for grouped analysis and paired Students t tests between pairs. A p value \< 0.05 was considered significant.|||||<|0.001||||||The above p value reflects the statistical analysis of BAT between baseline and 2 doses of ibrutinib.|ANOVA|Changes in BAT were analyzed at each time point using repeated measures ANOVA for grouped analysis and paired Students t tests between pairs.||||||<0.001
73967364|NCT05406921|147471989|SUPERIORITY||Mean Difference (Net)|0.32|||<|0.05|TWO_SIDED||||||ANOVA|||This was a feasibility study and not powered to detect significant differences pre-/post-intervention.||||<0.05
73967365|NCT02724878|147472054|SUPERIORITY||Response Rate|33.0|||||TWO_SIDED|80.0|25.0|42.0||||||A sample size of 60 would provide 95% power to distinguish the ORR rate of 25% from 10% (historical control) with 1-sided alpha of 0.07. The treatment would be considered effective if 10 or more responses are observed out of 60 patients.||42|25|
73967366|NCT03175029|147472074|SUPERIORITY||Mean Difference (Final Values)|10.552|||<|0.001|TWO_SIDED|95.0|5.514|15.59|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BCI in the TAC-302 group||15.590|5.514|<0.001
73967367|NCT03175029|147472074|SUPERIORITY||Mean Difference (Final Values)|-0.826||||0.819|TWO_SIDED|95.0|-8.676|7.023|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BCI in the Placebo group||7.023|-8.676|0.819
73967368|NCT03175029|147472074|SUPERIORITY||Mean Difference (Final Values)|11.378|STANDARD_ERROR_OF_MEAN|4.454||0.015|TWO_SIDED|95.0|2.345|20.411|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BCI from baseline to Week 12||20.411|2.345|0.015
73967369|NCT03175029|147472075|SUPERIORITY||Mean Difference (Final Values)|10.604|STANDARD_DEVIATION|8.76|<|0.001|TWO_SIDED|95.0|5.753|15.455|||t-test, 2 sided|||Baseline vs. Week 12 for the mean PIP1 in the TAC-302 group||15.455|5.753|<0.001
73967370|NCT03175029|147472075|SUPERIORITY||Mean Difference (Final Values)|4.926|STANDARD_DEVIATION|7.62||0.138|TWO_SIDED|95.0|-2.121|11.973|||t-test, 2 sided|||Baseline vs. Week 12 for the mean PIP1 in the Placebo group||11.973|-2.121|0.138
73967371|NCT03175029|147472075|SUPERIORITY||Mean Difference (Final Values)|5.678|STANDARD_ERROR_OF_MEAN|3.861||0.157|TWO_SIDED|95.0|-2.375|13.731|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean PIP1 from baseline to Week 12||13.731|-2.375|0.157
73967372|NCT03175029|147472076|SUPERIORITY||Mean Difference (Final Values)|10.91|STANDARD_DEVIATION|26.48||0.006|TWO_SIDED|95.0|3.22|18.59|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||18.59|3.22|0.006
74028075|NCT01380093|147610071|SUPERIORITY_OR_OTHER||LS Mean Difference|-310.0|||<|0.0001|TWO_SIDED|95.0|-384.5|-235.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-235.5|-384.5|<0.0001
74088479|NCT01221090|147730269|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Followed a healthful eating plan."||||0.68
73967373|NCT03175029|147472076|SUPERIORITY||Mean Difference (Final Values)|2.42|STANDARD_DEVIATION|20.09||0.57|TWO_SIDED|95.0|-6.27|11.1|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||11.10|-6.27|0.570
73967374|NCT03175029|147472076|SUPERIORITY||Mean Difference (Final Values)|8.49|STANDARD_ERROR_OF_MEAN|6.24||0.178|TWO_SIDED|95.0|-3.96|20.95|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||20.95|-3.96|0.178
73967375|NCT03175029|147472077|SUPERIORITY||Mean Difference (Final Values)|18.41|STANDARD_DEVIATION|24.39|<|0.001|TWO_SIDED|95.0|9.13|27.69|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||27.69|9.13|<0.001
73967376|NCT03175029|147472077|SUPERIORITY||Mean Difference (Final Values)|2.88|STANDARD_DEVIATION|15.7||0.489|TWO_SIDED|95.0|-5.81|11.58|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||11.58|-5.81|0.489
73967377|NCT03175029|147472077|SUPERIORITY||Mean Difference (Final Values)|15.53|STANDARD_ERROR_OF_MEAN|6.96||0.031|TWO_SIDED|95.0|1.48|29.58|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||29.58|1.48|0.031
73967378|NCT03175029|147472078|SUPERIORITY||Mean Difference (Final Values)|23.57|STANDARD_DEVIATION|25.54|<|0.001|TWO_SIDED|95.0|11.26|35.88|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||35.88|11.26|<0.001
73967379|NCT03175029|147472078|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|17.18||0.708|TWO_SIDED|95.0|-10.19|14.4|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||14.40|-10.19|0.708
73967380|NCT03175029|147472078|SUPERIORITY||Mean Difference (Final Values)|21.47|STANDARD_ERROR_OF_MEAN|9.02||0.025|TWO_SIDED|95.0|2.96|39.98|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||39.98|2.96|0.025
73971400|NCT03974178|147483465|OTHER|The hypothesis H0 (pdeath = 8.5% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Fatality rate|0.0||||0.0201|TWO_SIDED|90.0|0.0|6.58||The rate of deaths possibly related to r-HAT or to fexinidazole at the end of hospitalization was compared to the predefined unacceptable rate of 8.5%.|one-sided exact test|Clopper Pearson exact method||"The proportion of deaths (pdeath) is compared to the threshold of 8.5%, with H0 being pdeath = 8.5% or more.~The 90% confidence interval of the fatality rate is calculated with the Clopper-Pearson method."||6.58|0|0.0201
73971401|NCT03974178|147483466|OTHER|The hypothesis H0 (pfailure at the end of hospitalization = 9% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|0.0||||0.0158|TWO_SIDED|90.0|0.0|6.58||The rate of failures at the end of hospitalization was compared to the predefined unacceptable rate of 9%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at the end of hospitalization (pfailure) is compared to the threshold of 9%, with H0 being pfailure = 9% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||6.58|0|0.0158
73971402|NCT03974178|147483467|OTHER|The hypothesis H0 (pfailure at 12 months = 12% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|2.27||||0.0253|TWO_SIDED|90.0|0.12|10.34||The rate of failures at 12 months was compared to the predefined unacceptable rate of 12%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at 12 months (pfailure) is compared to the threshold of 12%, with H0 being pfailure = 12% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||10.34|0.12|0.0253
73920579|NCT02772081|147369109|SUPERIORITY||Adjusted difference|-15.4||||0.39|TWO_SIDED|95.0|-47.9|17.1|||Cochran-Mantel-Haenszel|||First Administration; Treatment comparison. Adjusted difference, its 95% confidence interval (CI) and p-value are estimated using Cochran-Mantel-Haenszel test||17.1|-47.9|0.390
73920580|NCT02772081|147369115|SUPERIORITY||Median Difference (Final Values)|5.0||||0.563|TWO_SIDED|95.0|-13.8|23.8|||Wilcoxon (Mann-Whitney)|||Duration of standalone oxygen supplementation||23.8|-13.8|0.563
73920581|NCT02772081|147369115|SUPERIORITY||Median Difference (Final Values)|1.0||||0.612|TWO_SIDED|95.0|-19.7|21.7|||Wilcoxon (Mann-Whitney)|||Duration of NIV||21.7|-19.7|0.612
73920582|NCT02772081|147369118|SUPERIORITY||Adjusted mean difference|-0.619||||0.137|TWO_SIDED|95.0|-1.447|0.21|||Mixed model for repeated measures|||T0, Treatment comparison. The analysis was based on an mixed model for repeated measures (MMRM) with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.210|-1.447|0.137
73920583|NCT02772081|147369118|SUPERIORITY||Adjusted mean difference|0.268||||0.534|TWO_SIDED|95.0|-0.604|1.14|||Mixed model for repeated measures|||5 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.140|-0.604|0.534
73920584|NCT02772081|147369118|SUPERIORITY||Adjusted mean difference|0.27||||0.53|TWO_SIDED|95.0|-0.597|1.136|||Mixed model for repeated measures|||15 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.136|-0.597|0.530
73920585|NCT02772081|147369118|SUPERIORITY||Adjusted mean difference|0.641||||0.091|TWO_SIDED|95.0|-0.108|1.389|||Mixed model for repeated measures|||30 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.389|-0.108|0.091
73920586|NCT02772081|147369118|SUPERIORITY||Adjusted mean difference|0.463||||0.04|TWO_SIDED|95.0|0.023|0.903|||Mixed model for repeated measures|||1 hour, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.903|0.023|0.040
73920587|NCT02772081|147369118|SUPERIORITY||Adjusted mean difference|0.166||||0.532|TWO_SIDED|95.0|-0.371|0.703|||Mixed model for repeated measures|||6 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.703|-0.371|0.532
73967381|NCT01426425|147472088|SUPERIORITY_OR_OTHER_LEGACY||Chronic effectiveness prob at 6 months|0.926|||<|0.0001|TWO_SIDED|95.0|0.895|0.948|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.83~Ha: PE \> 0.83~Where PE is the probability of a subject achieving chronic effectiveness success at the 6-month follow-up and 0.83 (83%) is the pre-specified performance goal."||0.948|0.895|<0.0001
73967382|NCT01426425|147472089|SUPERIORITY_OR_OTHER_LEGACY||Safety failure probability at 6 months|0.01|||<|0.0001|TWO_SIDED|95.0|0.004|0.027|||Kaplan-Meier log-log 95% CI||The chronic safety failure probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: Ps ≥ 0.07~Ha: Ps \< 0.07~Where Ps is the probability of a subject experiencing at least one safety event through 6 months with a 0.07 pre-specified performance goal."||0.027|0.004|<0.0001
73967383|NCT01426425|147472090|SUPERIORITY_OR_OTHER_LEGACY||Chronic effectiveness prob at 6 months|0.973|||<|0.0001|TWO_SIDED|95.0|0.95|0.985|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.80~Ha: PE \> 0.80~Where PE is the probability of a subject achieving chronic effectiveness success at 6-month follow-up, and 0.80 is the pre-specified performance goal. As pre-defined in the study protocol, this hypothesis is tested if the primary effectiveness objective null hypothesis (Ho) is rejected."||0.985|0.950|<0.0001
73967384|NCT03281291|147472097|OTHER||Vaccine Efficacy|29.7|||||TWO_SIDED|95.0|14.7|42.1|||Regression, Cox||VE = 1 minus the Hazard Ratio (HR). HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy (VE) in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for R012-20 Group vs Control Group.||42.1|14.7|
73967385|NCT03281291|147472097|OTHER||Vaccine Efficacy|31.2|||||TWO_SIDED|95.0|16.4|43.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for R012-14-mD Group vs Control Group.||43.3|16.4|
73967386|NCT03281291|147472097|OTHER||Vaccine Efficacy|24.6|||||TWO_SIDED|95.0|9.0|37.6|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx012-14-mFxD Group vs Control Group.||37.6|9.0|
73967387|NCT03281291|147472097|OTHER||Vaccine Efficacy|28.8|||||TWO_SIDED|95.0|13.9|41.1|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx017-mFxD Group vs Control Group.||41.1|13.9|
73967388|NCT03281291|147472098|OTHER||Vaccine Efficacy|42.8|||||TWO_SIDED|95.0|30.7|52.8|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 14, for R012-20 + R012-14-mD Pooled Group vs Control Group.||52.8|30.7|
73920588|NCT02772081|147369118|SUPERIORITY||Adjusted mean difference|0.048||||0.877|TWO_SIDED|95.0|-0.578|0.674|||Mixed model for repeated measures|||12 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.674|-0.578|0.877
73920589|NCT02772081|147369118|SUPERIORITY||Adjusted mean difference|0.244||||0.356|TWO_SIDED|95.0|-0.289|0.776|||Mixed model for repeated measures|||24 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.776|-0.289|0.356
73920590|NCT02772081|147369118|SUPERIORITY||Adjusted mean difference|0.303||||0.258|TWO_SIDED|95.0|-0.235|0.841|||Mixed model for repeated measures|||48 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.841|-0.235|0.258
73967389|NCT03281291|147472098|OTHER||Vaccine Efficacy|36.7|||||TWO_SIDED|95.0|21.2|49.2|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 14, for Fx012-14-mFxD Group vs Control Group.||49.2|21.2|
73967390|NCT03281291|147472098|OTHER||Vaccine Efficacy|41.4|||||TWO_SIDED|95.0|26.7|53.1|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 7.5 and 19, for Fx017-mFxD Group vs Control Group.||53.1|26.7|
73967391|NCT03281291|147472099|OTHER||Vaccine Efficacy|29.6|||||TWO_SIDED|95.0|15.4|41.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for R012-20 Group vs Control Group.||41.5|15.4|
73967392|NCT03281291|147472099|OTHER||Vaccine Efficacy|30.6|||||TWO_SIDED|95.0|16.6|42.2|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for R012-14-mD Group vs Control Group.||42.2|16.6|
73967393|NCT03281291|147472099|OTHER||Vaccine Efficacy|27.4|||||TWO_SIDED|95.0|13.1|39.4|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for Fx012-14-mFxD Group vs Control Group.||39.4|13.1|
73967394|NCT03281291|147472099|OTHER||Vaccine Efficacy|26.3|||||TWO_SIDED|95.0|11.9|38.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for Fx017-mFxD Group vs Control Group.||38.3|11.9|
73967395|NCT03281291|147472100|OTHER||Vaccine Efficacy|41.8|||||TWO_SIDED|95.0|28.6|52.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for R012-20 Group vs Control Group.||52.5|28.6|
73967396|NCT03281291|147472100|OTHER||Vaccine Efficacy|39.9|||||TWO_SIDED|95.0|26.8|50.6|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for R012-14-mD Group vs Control Group.||50.6|26.8|
74028076|NCT01380093|147610071|SUPERIORITY_OR_OTHER||LS Mean Difference|185.2|||<|0.0001|TWO_SIDED|95.0|110.8|259.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||259.5|110.8|<0.0001
74028077|NCT01380093|147610071|SUPERIORITY_OR_OTHER||LS Mean Difference|495.1|||<|0.0001|TWO_SIDED|95.0|420.6|569.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||569.7|420.6|<0.0001
73920591|NCT02772081|147369118|SUPERIORITY||Adjusted mean difference|0.022||||0.945|TWO_SIDED|95.0|-0.616|0.66|||Mixed model for repeated measures|||72 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.660|-0.616|0.945
73967397|NCT03281291|147472100|OTHER||Vaccine Efficacy|33.6|||||TWO_SIDED|95.0|19.3|45.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for Fx012-14-mFxD Group vs Control Group.||45.3|19.3|
73967398|NCT03281291|147472100|OTHER||Vaccine Efficacy|40.6|||||TWO_SIDED|95.0|27.2|51.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 7.5 and 31, for Fx017-mFxD Group vs Control Group.||51.5|27.2|
73967399|NCT03281291|147472101|OTHER||Additive difference|-1.5|||||TWO_SIDED|95.0|-1.979|-1.022|||Wald Test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for R012-20 Group vs Control Group.||-1.022|-1.979|
74028078|NCT01380093|147610072|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.5|||<|0.0001|TWO_SIDED|95.0|-38.7|-22.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-22.3|-38.7|<0.0001
73967400|NCT03281291|147472101|OTHER||Additive difference|-1.544|||||TWO_SIDED|95.0|-2.027|-1.061|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for R012-14-mD Group vs Control Group.||-1.061|-2.027|
73967401|NCT03281291|147472101|OTHER||Additive difference|-1.575|||||TWO_SIDED|95.0|-2.065|-1.085|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for Fx012-14-mFxD Group vs Control Group.||-1.085|-2.065|
73967402|NCT03281291|147472101|OTHER||Additive difference|-1.11|||||TWO_SIDED|95.0|-1.635|-0.586|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for Fx017-mFxD Group vs Control Group.||-0.586|-1.635|
73967403|NCT03281291|147472102|OTHER||Additive difference|-0.769|||||TWO_SIDED|95.0|-1.068|-0.469|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 14, for R012-20 + R012-14-mD Pooled Group vs Control Group.||-0.469|-1.068|
73967404|NCT03281291|147472102|OTHER||Additive difference|-0.786|||||TWO_SIDED|95.0|-1.133|-0.439|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 14, for Fx012-14-mFxD groups vs Control Group.||-0.439|-1.133|
73967405|NCT03281291|147472102|OTHER||Additive difference|-1.275|||||TWO_SIDED|95.0|-1.592|-0.959|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 7.5 to 19, for Fx017-mFxD groups vs Control Group.||-0.959|-1.592|
73967406|NCT03281291|147472103|OTHER||Additive difference|-2.686|||||TWO_SIDED|95.0|-3.448|-1.924|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for R012-20 Group vs Control Group.||-1.924|-3.448|
73967407|NCT03281291|147472103|OTHER||Additive difference|-2.452|||||TWO_SIDED|95.0|-3.217|-1.686|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for R012-14-mD Group vs Control Group.||-1.686|-3.217|
73967408|NCT03281291|147472103|OTHER||Additive difference|-2.585|||||TWO_SIDED|95.0|-3.345|-1.824|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for Fx012-14-mFxD Group vs Control Group.||-1.824|-3.345|
73967409|NCT03281291|147472103|OTHER||Additive difference|-1.897|||||TWO_SIDED|95.0|-2.726|-1.067|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for Fx017-mFxD Group vs Control Group.||-1.067|-2.726|
74028079|NCT01380093|147610072|SUPERIORITY_OR_OTHER||LS Mean Difference|30.8|||<|0.0001|TWO_SIDED|95.0|22.6|39.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||39.0|22.6|<0.0001
74028080|NCT01380093|147610072|SUPERIORITY_OR_OTHER||LS Mean Difference|61.3|||<|0.0001|TWO_SIDED|95.0|53.1|69.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||69.5|53.1|<0.0001
73967410|NCT03281291|147472104|OTHER||Additive difference|-1.633|||||TWO_SIDED|95.0|-2.252|-1.015|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for R012-20 group vs Control Group.||-1.015|-2.252|
74028081|NCT01380093|147610073|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8671|TWO_SIDED|95.0|-1.0|0.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.8|-1.0|0.8671
73920592|NCT02772081|147369118|SUPERIORITY||Adjusted mean difference|-0.075||||0.766|TWO_SIDED|95.0|-0.586|0.436|||Mixed model for repeated measures|||120 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.436|-0.586|0.766
73920593|NCT02772081|147369119|SUPERIORITY||Adjusted mean difference|0.051||||0.59|TWO_SIDED|95.0|-0.141|0.243|||Mixed model for repeated measures|||T0, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.243|-0.141|0.590
73967411|NCT03281291|147472104|OTHER||Additive difference|-1.997|||||TWO_SIDED|95.0|-2.601|-1.393|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for R012-14 group vs Control Group.||-1.393|-2.601|
73967412|NCT03281291|147472104|OTHER||Additive difference|-1.776|||||TWO_SIDED|95.0|-2.399|-1.153|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for Fx012-14-mFxD group vs Control Group.||-1.153|-2.399|
73967413|NCT03281291|147472104|OTHER||Additive difference|-1.843|||||TWO_SIDED|95.0|-2.527|-1.158|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 7.5 to 31, for Fx017-mFxD group vs Control Group.||-1.158|-2.527|
73967414|NCT04556656|147472167|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.162||0.167|TWO_SIDED|95.0|-0.54|0.09|||Mixed Models Analysis|||In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.||0.09|-0.54|0.1670
73967415|NCT04556656|147472168|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.162||0.1598|TWO_SIDED|95.0|-0.55|0.09|||Mixed Models Analysis|||In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.||0.09|-0.55|0.1598
73967416|NCT04556656|147472169|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.148||0.4544|TWO_SIDED|95.0|-0.4|0.18|||Mixed Models Analysis|||In the MMRM, change in cUHDRS score from baseline was the dependent variable, while independent variables included treatment arm, baseline cUHDRS, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level. No imputation was performed on missing data.||0.18|-0.4|0.4544
73967417|NCT04556656|147472170|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.156||0.0038|TWO_SIDED|95.0|0.15|0.76|||Mixed Models Analysis|||"From baseline to Week 26.~In the MMRM model, change in cUHDRS score from baseline was the dependent variable and independent variables included treatment group, baseline cUHDRS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data."||0.76|0.15|0.0038
73967418|NCT04556656|147472170|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.179||0.0135|TWO_SIDED|95.0|0.09|0.8|||Mixed Models Analysis|||From baseline to Week 39||0.80|0.09|0.0135
74028082|NCT01380093|147610073|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.0001|TWO_SIDED|95.0|0.9|2.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.7|0.9|0.0001
74086682|NCT03396874|147727006|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|91.25|||<|1e-07|TWO_SIDED|95.0|84.19|100.0||p-value = 2.9e-15|Exact binomial proportion test|||PPV, composite standard, soft tissues: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In soft tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|84.19|<0.0000001
73920594|NCT02772081|147369119|SUPERIORITY||Adjusted mean difference|-0.051||||0.511|TWO_SIDED|95.0|-0.21|0.107|||Mixed model for repeated measures|||5 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.107|-0.210|0.511
74028083|NCT01380093|147610073|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|||<|0.0001|TWO_SIDED|95.0|1.0|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.0|<0.0001
74088480|NCT01221090|147730270|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust Variance Estimation.||"This analysis was to compare the quality of life measure, Number of days physical health was not good in the past 30 days at the 12 month follow-up visit."||||0.685
73861460|NCT04411420|147268788|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.877|TWO_SIDED|95.0|-0.19|0.17||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.17|-0.19|0.877
73920595|NCT02772081|147369119|SUPERIORITY||Adjusted mean difference|-0.05||||0.488|TWO_SIDED|95.0|-0.196|0.096|||Mixed model for repeated measures|||15 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.096|-0.196|0.488
73920596|NCT02772081|147369119|SUPERIORITY||Adjusted mean difference|-0.11||||0.091|TWO_SIDED|95.0|-0.239|0.019|||Mixed model for repeated measures|||30 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.019|-0.239|0.091
73920597|NCT02772081|147369119|SUPERIORITY||Adjusted mean difference|-0.024||||0.344|TWO_SIDED|95.0|-0.076|0.027|||Mixed model for repeated measures|||1 hour, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.027|-0.076|0.344
73920598|NCT02772081|147369119|SUPERIORITY||Adjusted mean difference|-0.026||||0.376|TWO_SIDED|95.0|-0.084|0.033|||Mixed model for repeated measures|||6 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.033|-0.084|0.376
73920599|NCT02772081|147369119|SUPERIORITY||Adjusted mean difference|-0.04||||0.396|TWO_SIDED|95.0|-0.135|0.055|||Mixed model for repeated measures|||12 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.055|-0.135|0.396
73920600|NCT02772081|147369119|SUPERIORITY||Adjusted mean difference|-0.026||||0.268|TWO_SIDED|95.0|-0.074|0.021|||Mixed model for repeated measures|||24 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.021|-0.074|0.268
73920601|NCT02772081|147369119|SUPERIORITY||Adjusted mean difference|-0.037||||0.147|TWO_SIDED|95.0|-0.089|0.014|||Mixed model for repeated measures|||48 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.014|-0.089|0.147
73920602|NCT02772081|147369119|SUPERIORITY||Adjusted mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.055|0.055|||Mixed model for repeated measures|||72 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.055|-0.055|0.994
73920603|NCT02772081|147369119|SUPERIORITY||Adjusted mean difference|-0.004||||0.853|TWO_SIDED|95.0|-0.048|0.04|||Mixed model for repeated measures|||120 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.040|-0.048|0.853
73967419|NCT04556656|147472170|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.193||0.0351|TWO_SIDED|95.0|0.03|0.79|||Mixed Models Analysis|||From baseline to Week 52||0.79|0.03|0.0351
74028084|NCT01380093|147610074|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-17.0|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.0|-17.0|<0.0001
73920604|NCT02772081|147369120|SUPERIORITY||Adjusted mean difference|-10.4||||0.09|TWO_SIDED|95.0|-22.6|1.7|||Mixed model for repeated measures|||T0; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||1.7|-22.6|0.090
73920605|NCT02772081|147369120|SUPERIORITY||Adjusted mean difference|-0.3||||0.917|TWO_SIDED|95.0|-6.4|5.8|||Mixed model for repeated measures|||5 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.8|-6.4|0.917
73920606|NCT02772081|147369120|SUPERIORITY||Adjusted mean difference|-1.5||||0.668|TWO_SIDED|95.0|-8.5|5.6|||Mixed model for repeated measures|||15 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.6|-8.5|0.668
73920607|NCT02772081|147369120|SUPERIORITY||Adjusted mean difference|4.0||||0.149|TWO_SIDED|95.0|-1.5|9.6|||Mixed model for repeated measures|||30 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||9.6|-1.5|0.149
73920608|NCT02772081|147369120|SUPERIORITY||Adjusted mean difference|1.8||||0.318|TWO_SIDED|95.0|-1.9|5.5|||Mixed model for repeated measures|||1 hour; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.5|-1.9|0.318
74028085|NCT01380093|147610074|SUPERIORITY_OR_OTHER||LS Mean Difference|8.8|||<|0.0001|TWO_SIDED|95.0|4.8|12.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||12.8|4.8|<0.0001
73920609|NCT02772081|147369120|SUPERIORITY||Adjusted mean difference|1.6||||0.148|TWO_SIDED|95.0|-0.6|3.7|||Wilcoxon (Mann-Whitney)|||6 hour; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||3.7|-0.6|0.148
73967420|NCT04556656|147472170|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.197||0.1683|TWO_SIDED|95.0|-0.12|0.66|||Mixed Models Analysis|||From baseline to Week 65.||0.66|-0.12|0.1683
73967421|NCT04556656|147472170|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.223||0.5315|TWO_SIDED|95.0|-0.3|0.58|||Mixed Models Analysis|||From baseline to Week 78||0.58|-0.30|0.5315
73920610|NCT02772081|147369120|SUPERIORITY||Adjusted mean difference|3.3||||0.333|TWO_SIDED|95.0|-3.6|10.2|||Mixed model for repeated measures|||12 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||10.2|-3.6|0.333
73920611|NCT02772081|147369120|SUPERIORITY||Adjusted mean difference|0.9||||0.56|TWO_SIDED|95.0|-2.2|4.0|||Mixed model for repeated measures|||24 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.0|-2.2|0.560
73920612|NCT02772081|147369120|SUPERIORITY||Adjusted mean difference|2.0||||0.089|TWO_SIDED|95.0|-0.3|4.3|||Mixed model for repeated measures|||48 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.3|-0.3|0.089
73920613|NCT02772081|147369120|SUPERIORITY||Adjusted mean difference|1.9||||0.115|TWO_SIDED|95.0|-0.5|4.4|||Mixed model for repeated measures|||72 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.4|-0.5|0.115
73920614|NCT02772081|147369120|SUPERIORITY||Adjusted mean difference|1.1||||0.284|TWO_SIDED|95.0|-1.0|3.3|||Mixed model for repeated measures|||120 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||3.3|-1.0|0.284
73920615|NCT02772081|147369121|SUPERIORITY||Adjusted difference|-15.7||||0.22|TWO_SIDED|95.0|-39.6|8.2|||Cochran-Mantel-Haenszel|||Any intubation procedure in first 72 hours of life.||8.2|-39.6|0.220
73920616|NCT02772081|147369121|SUPERIORITY||Adjusted difference|4.9||||0.741|TWO_SIDED|95.0|-22.8|32.5|||Cochran-Mantel-Haenszel|||Any intubation procedure within 36 weeks PMA.||32.5|-22.8|0.741
73920617|NCT02772081|147369122|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.333|TWO_SIDED|95.0|-32.3|16.3|||Wilcoxon (Mann-Whitney)|||Duration of invasive MV in first 28 days PNA.||16.3|-32.3|0.333
73920618|NCT02772081|147369122|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.334|TWO_SIDED|95.0|-49.5|33.5|||Wilcoxon (Mann-Whitney)|||Duration of invasive MV within 36 weeks PMA.||33.5|-49.5|0.334
73920619|NCT02772081|147369123|SUPERIORITY||Adjusted difference|-28.6||||0.596|TWO_SIDED|95.0|-120.9|63.6|||Wilcoxon (Mann-Whitney)|||Duration of invasive mechanical ventilation.||63.6|-120.9|0.596
73920620|NCT02772081|147369124|SUPERIORITY||CMH adjusted difference|-18.6||||0.219|TWO_SIDED|95.0|-47.0|9.8||The percentage of neonates needing invasive MV in the first 72 hours of life, was compared between the treatment groups using the Cochran-Mantel-Haenszel (CMH) test, adjusted for gestational age (GA) group.|Cochran-Mantel-Haenszel|||Invasive MV in the first 72 hours of life.||9.8|-47.0|0.219
73920621|NCT02772081|147369124|SUPERIORITY||Adjusted difference|-3.4||||0.826|TWO_SIDED|95.0|-33.5|26.7|||Cochran-Mantel-Haenszel|||Invasive MV in first 28 days PNA||26.7|-33.5|0.826
73920622|NCT02772081|147369124|SUPERIORITY||Adjusted difference|-3.4||||0.826|TWO_SIDED|95.0|-33.5|26.7|||Cochran-Mantel-Haenszel|||Invasive MV within 36 weeks PMA.||26.7|-33.5|0.826
73920623|NCT02598076|147369131|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
73967422|NCT04556656|147472171|SUPERIORITY||Mean Difference (Final Values)|-21.15|STANDARD_ERROR_OF_MEAN|9.406||0.0253|TWO_SIDED|95.0|-39.66|-2.64|||Mixed Models Analysis||Negative change = improvement.|From baseline to Week 26. In the MMRM model, change in Q-Motor Finger Tapping IOI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Finger Tapping IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed.||-2.64|-39.66|0.0253
73967423|NCT04556656|147472171|SUPERIORITY||Mean Difference (Final Values)|-14.31|STANDARD_ERROR_OF_MEAN|9.853||0.1474|TWO_SIDED|95.0|-33.71|5.08|||Mixed Models Analysis|||From baseline to Week 52.||5.08|-33.71|0.1474
73967424|NCT04556656|147472171|SUPERIORITY||Mean Difference (Final Values)|-24.71|STANDARD_ERROR_OF_MEAN|10.185||0.0159|TWO_SIDED|95.0|-44.76|-4.67|||Mixed Models Analysis|||From baseline to Week 65.||-4.67|-44.76|0.0159
73920624|NCT02598076|147369132|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||||||0.034
73920625|NCT02598076|147369133|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
73920626|NCT02598076|147369134|SUPERIORITY|||||||0.095|||||||Fisher Exact|||||||0.095
73920627|NCT02598076|147369135|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
73920628|NCT03227029|147369141|OTHER||% vaccine recipients with solicited AEs|64.0|||||TWO_SIDED|90.0|46.0|80.0|||||Proportions of study participants were calculated and presented with 90% exact confidence intervals. This highlights that we are 95% sure that the true proportion is not higher that the upper limit of the confidence interval.|||80|46|
73920629|NCT03227029|147369141|OTHER||% vaccine recipients with solicited AEs|84.0|||||TWO_SIDED|90.0|67.0|94.0||||||||94|67|
73920630|NCT03227029|147369141|OTHER||% placebo recipients with solicited AEs|58.0|||||TWO_SIDED|90.0|32.0|82.0||||||||82|32|
73920631|NCT03227029|147369142|OTHER||% vaccine recipients with usolicited AEs|36.0|||||TWO_SIDED|90.0|20.0|54.0||||||||54|20|
73920632|NCT03227029|147369142|OTHER||% vaccine recipients with usolicited AEs|52.0|||||TWO_SIDED|90.0|34.0|69.0||||||||69|34|
73920633|NCT03227029|147369142|OTHER||% placebo recipients with usolicited AEs|42.0|||||TWO_SIDED|90.0|18.0|68.0||||||||68|18|
73920634|NCT03227029|147369144|OTHER||% recipients infected with vaccine virus|88.0|||||TWO_SIDED|90.0|72.0|97.0||||||||97|72|
73920635|NCT03227029|147369144|OTHER||% recipients infected with vaccine virus|96.0|||||TWO_SIDED|90.0|82.0|100.0||||||||100|82|
73920636|NCT03227029|147369144|OTHER||% recipients infected with vaccine virus|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
73920637|NCT03227029|147369147|OTHER||% with >=4 fold rise in RSV-PRNT|60.0|||||TWO_SIDED|90.0|42.0|76.0||||||||76|42|
73920638|NCT03227029|147369147|OTHER||% with >=4 fold rise in RSV-PRNT|92.0|||||TWO_SIDED|90.0|76.0|98.0||||||||98|76|
73920639|NCT03227029|147369147|OTHER||% with >=4 fold rise in RSV-PRNT|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
73967425|NCT04556656|147472171|SUPERIORITY||Mean Difference (Final Values)|-22.9|STANDARD_ERROR_OF_MEAN|10.38||0.0283|TWO_SIDED|95.0|-43.34|-2.45|||Mixed Models Analysis|||From baseline to Week 78.||-2.45|-43.34|0.0283
73967426|NCT04556656|147472172|SUPERIORITY||Mean Difference (Final Values)|-38.06|STANDARD_ERROR_OF_MEAN|10.999||0.0007|TWO_SIDED|95.0|-59.74|-16.37|||Mixed Models Analysis|||From baseline to Week 26. In MMRM model, change in Q-Motor Pronation/Supination ITI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Q-Motor Pronation/Supination ITI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||-16.37|-59.74|0.0007
73967427|NCT04556656|147472172|SUPERIORITY||Mean Difference (Final Values)|-20.21|STANDARD_ERROR_OF_MEAN|12.547||0.1087|TWO_SIDED|95.0|-44.95|4.53|||Mixed Models Analysis|||From baseline to Week 52.||4.53|-44.95|0.1087
73920640|NCT03227029|147369147|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
73920641|NCT03227029|147369147|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
73920642|NCT03227029|147369148|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
73920643|NCT03227029|147369148|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
73920644|NCT03227029|147369149|OTHER||% with >=4 fold rise in RSV F protein|60.0|||||TWO_SIDED|90.0|42.0|76.0||||||||76|42|
73920645|NCT03227029|147369149|OTHER||% with >=4 fold rise in RSV F protein|92.0|||||TWO_SIDED|90.0|76.0|98.0||||||||98|76|
73920646|NCT03227029|147369149|OTHER||% with >=4 fold rise in RSV F protein|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
73920647|NCT03227029|147369149|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
73920648|NCT03227029|147369149|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
73920649|NCT03227029|147369150|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
73920650|NCT03227029|147369150|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
73920651|NCT01506479|147369162|SUPERIORITY||Mean Difference (Final Values)|14.3|||<|0.0001|TWO_SIDED|95.0|12.0|16.6|||t-test, 2 sided|||||16.6|12.0|<0.0001
74028086|NCT01380093|147610074|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8|||<|0.0001|TWO_SIDED|95.0|17.8|25.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||25.8|17.8|<0.0001
73967428|NCT04556656|147472172|SUPERIORITY||Mean Difference (Final Values)|-23.92|STANDARD_ERROR_OF_MEAN|11.541||0.0395|TWO_SIDED|95.0|-46.68|-1.16|||Mixed Models Analysis|||From baseline to Week 65.||-1.16|-46.68|0.0395
73920652|NCT01506479|147369163|OTHER||Mean Difference (Final Values)|2.9||||0.34|ONE_SIDED|90.0||4.6||The a priori threshold for statistical significance was 0.10|t-test, 1 sided|||The null hypothesis is that the vigorous exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference between the mean change in the control group and the mean change in the vigorous exercise group). The alternative hypothesis is that vigorous exercise does not warrant further investigation.||4.6||0.34
73920653|NCT01506479|147369163|OTHER||Mean Difference (Final Values)|1.2||||0.03|ONE_SIDED|90.0||2.8||The a priori threshold for statistical significance was set to 0.10. If the p-value is less than 0.10, the null hypothesis is rejected in favor of the alternative (moderate exercise does not warrant further investigation).|t-test, 1 sided||"The estimate is the difference between the control group and the moderate exercise group.~The upper bound of the confidence interval should be compared to the futility threshold of 3.5 to reject or not reject the null hypothesis."|The null hypothesis is that the moderate exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference in the mean change between the control group and the moderate exercise group). The alternative hypothesis is that moderate exercise does not warrant further investigation .||2.8||0.03
73920654|NCT01506479|147369164|SUPERIORITY|||||||0.1334|||||||t-test, 2 sided|||||||0.1334
73920655|NCT01896531|147369217|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.12|||=|0.56|TWO_SIDED|90.0|0.81|1.55|||Log Rank|||All randomized participants||1.55|0.81|= 0.56
73920656|NCT01896531|147369217|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.07|||=|0.86|TWO_SIDED|90.0|0.54|2.11|||Log Rank|||Participants with PTEN loss tumors||2.11|0.54|= 0.86
73920657|NCT01896531|147369218|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.52|||=|0.0234|TWO_SIDED|90.0|1.12|2.07|||Log Rank|||All randomized participants||2.07|1.12|= 0.0234
73920658|NCT01896531|147369218|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.66|||=|0.2867|TWO_SIDED|90.0|0.75|3.65|||Log Rank|||Participants with PTEN loss tumors||3.65|0.75|= 0.2867
73920659|NCT01896531|147369218|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.66|||=|0.1369|TWO_SIDED|90.0|0.94|2.93|||Log Rank|||Participants who are Akt Dx+||2.93|0.94|= 0.1369
73920660|NCT01896531|147369219|SUPERIORITY||Difference in Response Rates|-5.2|||=|0.5202|TWO_SIDED|90.0|-18.46|8.06|||Cochran-Mantel-Haenszel|||All randomized participants||8.06|-18.46|= 0.5202
73920661|NCT01896531|147369219|SUPERIORITY||Difference in Response Rates|-23.33|||=|0.2035|TWO_SIDED|90.0|-52.24|5.58|||Cochran-Mantel-Haenszel|||Participants with PTEN loss tumors||5.58|-52.24|= 0.2035
73920662|NCT01896531|147369219|SUPERIORITY||Difference in Response Rates|-4.35|||=|0.7697|TWO_SIDED|90.0|-28.48|19.79|||Cochran-Mantel-Haenszel|||Participants who are Akt Dx+||19.79|-28.48|= 0.7697
73920663|NCT01896531|147369220|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.14|||=|0.5974|TWO_SIDED|90.0|0.76|1.73|||Log Rank|||All randomized participants||1.73|0.76|= 0.5974
73920664|NCT01896531|147369220|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.71|||=|0.5385|TWO_SIDED|90.0|0.28|1.79|||Log Rank|||Participants with PTEN loss tumors||1.79|0.28|= 0.5385
73920665|NCT01896531|147369220|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.78|||=|0.6097|TWO_SIDED|90.0|0.35|1.75|||Log Rank|||Participants who are Akt Dx+||1.75|0.35|= 0.6097
73920666|NCT00770289|147369226|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.899|||<|0.0001|TWO_SIDED|95.0|0.886|0.911||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.911|0.886|<0.0001
73920667|NCT00770289|147369226|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.797|||<|0.0001|TWO_SIDED|95.0|0.771|0.82||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.820|0.771|<0.0001
73920668|NCT00770289|147369226|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.765|||<|0.0001|TWO_SIDED|95.0|0.736|0.791||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.791|0.736|<0.0001
73920669|NCT01958008|147369321|SUPERIORITY_OR_OTHER||Slope|1.2674|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|95.0|1.0636|1.4713|||Regression, Linear|Power model that describes the functional relationship between the dose and pharmacokinetic endpoint Cmax,ss||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model||1.4713|1.0636|
73920670|NCT01958008|147369322|SUPERIORITY_OR_OTHER||Slope|1.2139|STANDARD_ERROR_OF_MEAN|0.081|||TWO_SIDED|95.0|1.0519|1.3759|||Regression, Linear|Power model that describes the functional relationship between the dose and pharmacokinetic endpoint AUC tau,ss||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model||1.3759|1.0519|
73920671|NCT02028065|147369330|SUPERIORITY_OR_OTHER||Difference in incidence|5.3|||||TWO_SIDED|95.0|-0.9|10.7|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26\[4\]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).||10.7|-0.9|
73920672|NCT02028065|147369330|SUPERIORITY_OR_OTHER||Difference in incidence|8.1|||||TWO_SIDED|95.0|1.7|14.2|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen(Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26\[4\]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).||14.2|1.7|
73920673|NCT02028065|147369331|SUPERIORITY_OR_OTHER||Difference in incidence|0.0|||||TWO_SIDED|95.0|-4.8|2.5|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|||2.5|-4.8|
73920674|NCT02028065|147369331|SUPERIORITY_OR_OTHER||Difference in incidence|0.7|||||TWO_SIDED|95.0|-4.2|3.7|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|||3.7|-4.2|
73920675|NCT00867009|147369369|SUPERIORITY_OR_OTHER||Percentage of participants with response|38.5|||||TWO_SIDED|80.0|32.3|45.09||||||||45.09|32.30|
73920676|NCT00867009|147369370|SUPERIORITY_OR_OTHER||Median number of months|5.82|||||TWO_SIDED|80.0|4.4|6.7||||||||6.70|4.40|
73920677|NCT00867009|147369371|SUPERIORITY_OR_OTHER||Percentage of participants with response|45.0|||||TWO_SIDED|80.0|39.0|51.0||||||||51|39|
73920678|NCT00867009|147369372|SUPERIORITY_OR_OTHER||Percentage of participants with response|59.6|||||TWO_SIDED|80.0|53.06|65.94||||||||65.94|53.06|
73920679|NCT00459667|147369390|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|17.4||||||95.0|14.4|20.7||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||20.7|14.4|
73967429|NCT04556656|147472172|SUPERIORITY||Mean Difference (Final Values)|-22.23|STANDARD_ERROR_OF_MEAN|13.587||0.1038|TWO_SIDED|95.0|-49.08|4.61|||Mixed Models Analysis|||From baseline to Week 78.||4.61|-49.08|0.1038
74028087|NCT01380093|147610075|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.3|||<|0.0001|TWO_SIDED|95.0|-55.3|-35.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.3|-55.3|<0.0001
73920680|NCT00459667|147369390|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|15.8||||||95.0|13.1|18.9||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||18.9|13.1|
73920681|NCT00459667|147369390|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|31.1||||||95.0|24.4|38.4||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||38.4|24.4|
74028088|NCT01380093|147610075|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.0001|TWO_SIDED|95.0|14.6|34.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.5|14.6|<0.0001
74028089|NCT01380093|147610075|SUPERIORITY_OR_OTHER||LS Mean Difference|69.8|||<|0.0001|TWO_SIDED|95.0|59.9|79.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||79.8|59.9|<0.0001
73920682|NCT00459667|147369391|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|31.7||||||95.0|28.0|35.7||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||35.7|28.0|
73920683|NCT00459667|147369391|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|26.2||||||95.0|22.8|29.8||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||29.8|22.8|
73920684|NCT00459667|147369391|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|31.7||||||95.0|24.9|39.0||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||39.0|24.9|
73920685|NCT00556712|147369401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.82|||Log Rank|||||0.82|0.62|<0.0001
73920686|NCT00556712|147369405|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0097|TWO_SIDED|95.0|0.72|0.96|||Log Rank|||||0.96|0.72|0.0097
73920687|NCT00556712|147369408|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.005|TWO_SIDED|95.0|0.66|0.93|||Log Rank|||||0.93|0.66|0.0050
73920688|NCT00556712|147369411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.1768|TWO_SIDED|95.0|0.51|1.14|||Log Rank|||||1.14|0.51|0.1768
73920689|NCT00556712|147369414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4797|TWO_SIDED|95.0|0.49|1.4|||Log Rank|||||1.40|0.49|0.4797
73920690|NCT00556712|147369416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.61|0.82|||Log Rank|||||0.82|0.61|<0.0001
73920691|NCT00556712|147369418|SUPERIORITY_OR_OTHER||Difference in Response Rates|6.53||||0.0006|TWO_SIDED|95.0|2.7|10.3|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||10.3|2.7|0.0006
73920692|NCT00556712|147369420|SUPERIORITY_OR_OTHER||Difference in Response Upgrade Rates|4.2||||0.0007|TWO_SIDED|95.0|1.6|6.7|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||6.7|1.6|0.0007
73920693|NCT00556712|147369422|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|9.8||||0.0035|TWO_SIDED|95.0|3.1|16.4|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD rate.||16.4|3.1|0.0035
73920694|NCT00556712|147369422|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|13.4|||<|0.0001|TWO_SIDED|95.0|7.1|19.7|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD \> 12 weeks rate.||19.7|7.1|<0.0001
73920695|NCT00556712|147369424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.3787|TWO_SIDED|95.0|0.74|1.12|||Log Rank|||||1.12|0.74|0.3787
73920696|NCT00556712|147369426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82|||Log Rank|||||0.82|0.58|< 0.0001
73920697|NCT00556712|147369429|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5385|TWO_SIDED|95.0|0.87|1.31|||Log Rank|||||1.31|0.87|0.5385
73920698|NCT00556712|147369432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.653|TWO_SIDED|95.0|0.79|1.16|||Log Rank|||||1.16|0.79|0.6530
73920699|NCT01031069|147369491|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\>) 0.5 for HPV-16 type.|Adjusted GMT ratio|2.95|||||TWO_SIDED|95.0|1.92|4.52||||||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|4.52|1.92|
73920700|NCT01031069|147369491|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\>) 0.5 for HPV-18 type.|Adjusted GMT ratio|7.83|||||TWO_SIDED|95.0|4.84|12.66||||||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|12.66|4.84|
73920701|NCT01031069|147369492|SUPERIORITY|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-18 type, with a statistically significant p-value.|Adjusted GMT ratio|7.44|||<|0.0001|TWO_SIDED|95.0|4.79|11.54|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, assessed following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|11.54|4.79|<0.0001
73920702|NCT01031069|147369492|SUPERIORITY|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-16 type, with a statistically significant p-value.|Adjusted GMT ratio|2.74|||<|0.0001|TWO_SIDED|95.0|1.83|4.11|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|4.11|1.83|<0.0001
74028090|NCT01380093|147610076|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.1|||<|0.0001|TWO_SIDED|95.0|-129.3|-88.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-88.8|-129.3|<0.0001
73920703|NCT01031069|147369509|SUPERIORITY|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-18 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|5.38|||<|0.0001|TWO_SIDED|97.5|3.2|9.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.||9.06|3.20|<0.0001
73920704|NCT01031069|147369509|SUPERIORITY|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-16 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|3.05|||<|0.0001|TWO_SIDED|97.5|1.84|5.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.||5.06|1.84|<0.0001
74028091|NCT01380093|147610076|SUPERIORITY_OR_OTHER||LS Mean Difference|60.1|||<|0.0001|TWO_SIDED|95.0|39.9|80.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||80.4|39.9|<0.0001
74028092|NCT01380093|147610076|SUPERIORITY_OR_OTHER||LS Mean Difference|169.2|||<|0.0001|TWO_SIDED|95.0|148.9|189.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||189.5|148.9|<0.0001
74086683|NCT03396874|147727006|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|93.59|||<|1e-07|TWO_SIDED|95.0|86.99|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, soft tissues: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In soft tissues, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|86.99|<0.0000001
74086684|NCT03396874|147727006|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|95.17|||<|1e-07|TWO_SIDED|95.0|91.12|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, bone: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In bone tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|91.12|<0.0000001
74088481|NCT01221090|147730270|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days mental health was not good in the past 30 days at the 12 month follow-up visit."||||0.997
73920705|NCT00353262|147369634|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.9|||||TWO_SIDED|90.0|0.79|1.02||||||Cycle 2, Day 1 versus Cycle 1, Day 1||1.02|0.79|
73920706|NCT00353262|147369634|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.76|0.99||||||Cycle 3, Day 1 versus Cycle 1, Day 1||0.99|0.76|
73920707|NCT00353262|147369634|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.85|1.1||||||Cycle 3, Day 1 to Cycle 2, Day 1||1.10|0.85|
73920708|NCT00353262|147369635|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|1.01|1.08||||||Cycle 2, Day 1 versus Cycle 1, Day 2||1.08|1.01|
73920709|NCT00353262|147369635|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.98|1.05||||||Cycle 3, Day 1 to Cycle 1, Day 2||1.05|0.98|
73920710|NCT00353262|147369635|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.94|1.0||||||Cycle 3, Day 1 to Cycle 2, Day 1||1.00|0.94|
73920711|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.83|1.24||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1||1.24|0.83|
73920712|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.16|||||TWO_SIDED|90.0|0.94|1.42||||||Capecitabine: Cycle 3, Day 1 to Cycle 2, Day 1||1.42|0.94|
73920713|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.17|||||TWO_SIDED|90.0|0.96|1.44||||||Capecitabine: Cycle 3, Day 1 to Cycle 1, Day 1||1.44|0.96|
73920714|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.69|1.08||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1||1.08|0.69|
73920715|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.86|1.34||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1||1.34|0.86|
73920716|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.25|||||TWO_SIDED|90.0|1.0|1.55||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.55|1.00|
73920717|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.81|||||TWO_SIDED|90.0|0.66|1.01||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1||1.01|0.66|
73920718|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.79|||||TWO_SIDED|90.0|0.64|0.97||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1||0.97|0.64|
73920719|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.78|1.19||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1||1.19|0.78|
74028093|NCT01380093|147610077|SUPERIORITY_OR_OTHER||LS Mean Difference|-207.0|||<|0.0001|TWO_SIDED|95.0|-242.0|-172.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-172.1|-242.0|<0.0001
74028094|NCT01380093|147610077|SUPERIORITY_OR_OTHER||LS Mean Difference|118.7|||<|0.0001|TWO_SIDED|95.0|83.9|153.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||153.5|83.9|<0.0001
73920720|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1||1.04|0.91|
73920721|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.9|1.04||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1||1.04|0.90|
73920722|NCT00353262|147369636|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.93|1.07||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1||1.07|0.93|
73920723|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.74|||||TWO_SIDED|90.0|0.61|0.9||||||5'-DFUR: Cycle 2, Day 1 versus Cycle 1, Day 1||0.90|0.61|
73920724|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.64|||||TWO_SIDED|90.0|0.53|0.79||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 1, Day 1||0.79|0.53|
73920725|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.71|1.06||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.06|0.71|
73920726|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|90.0|0.63|1.08||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1||1.08|0.63|
73920727|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.03|||||TWO_SIDED|90.0|0.78|1.34||||||Capecitabine: Cycle 3, Day 1 versus Cycle 2, Day 1||1.34|0.78|
73920728|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.65|1.1||||||Capecitabine: Cycle 3, Day 1 versus Cycle 1, Day 1||1.10|0.65|
73920729|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.65|1.18||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1||1.18|0.65|
73920730|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.71|1.3||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1||1.30|0.71|
73920731|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.1|||||TWO_SIDED|90.0|0.81|1.49||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.49|0.81|
73920732|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.74|||||TWO_SIDED|90.0|0.56|0.98||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1||0.98|0.56|
73920733|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.58|||||TWO_SIDED|90.0|0.44|0.76||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1||0.76|0.44|
73920734|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.78|||||TWO_SIDED|90.0|0.59|1.03||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1||1.03|0.59|
73920735|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1||1.00|0.83|
73920736|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.76|0.91||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1||0.91|0.76|
74088482|NCT01221090|147730270|SUPERIORITY_OR_OTHER|||||||0.3067||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days poor physical/mental health prevented usual activity in the past 30 days at the 12 month follow-up visit."||||0.3067
74088483|NCT01286558|147730332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||||95.0|-0.22|3.14|||ANCOVA|||||3.14|-0.22|
73920737|NCT00353262|147369638|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1||1.00|0.83|
73920738|NCT00353262|147369640|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.2|||||TWO_SIDED|90.0|1.09|1.33||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.33|1.09|
73920739|NCT00353262|147369640|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.34|||||TWO_SIDED|90.0|1.21|1.48||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.48|1.21|
73920740|NCT00353262|147369640|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.01|1.23||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.23|1.01|
73920741|NCT00353262|147369642|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.09|0.96|
73920742|NCT00353262|147369642|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.08|0.95|
73920743|NCT00353262|147369642|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.05|0.93|
73920744|NCT00353262|147369642|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.94|1.09||||||Free Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.09|0.94|
73920745|NCT00353262|147369642|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.92|1.08||||||Free Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.08|0.92|
73920746|NCT00353262|147369642|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.91|1.07||||||Free Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.07|0.91|
73920747|NCT01103284|147369658|SUPERIORITY_OR_OTHER|||||||0.33||||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The Mixed-Effect Model Repeated Measure (MMRM) was adjusted for the following baseline covariates: age, C-peptide, insulin dose by body weight and AUC||||||0.33
73967430|NCT04556656|147472173|SUPERIORITY||Mean Difference (Final Values)|-30.38|STANDARD_ERROR_OF_MEAN|12.902||0.0193|TWO_SIDED|95.0|-55.78|-4.98|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in Pronation/Supination IOI Mean from BL was the dependent variable and independent variables included treatment group, BL Pronation/Supination IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), treatment by categorical week interaction, conc. use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||-4.98|-55.78|0.0193
73967431|NCT04556656|147472173|SUPERIORITY||Mean Difference (Final Values)|-16.84|STANDARD_ERROR_OF_MEAN|15.17||0.268|TWO_SIDED|95.0|-46.69|13.02|||Mixed Models Analysis|||From baseline to Week 52.||13.02|-46.69|0.2680
73920748|NCT01103284|147369659|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED|||||A priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC.||||||0.68
73920749|NCT01103284|147369660|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC||||||0.44
73967432|NCT04556656|147472173|SUPERIORITY||Mean Difference (Final Values)|-22.79|STANDARD_ERROR_OF_MEAN|14.829||0.1255|TWO_SIDED|95.0|-51.97|6.4|||Mixed Models Analysis|||From baseline to Week 65.||6.4|-51.97|0.1255
74088484|NCT01286558|147730333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||||95.0|-0.36|4.64|||ANCOVA|||||4.64|-0.36|
73920750|NCT01103284|147369662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.07|TWO_SIDED|95.0|-0.02|0.79||Standard multiple imputation was used to predict the number and timing of hypoglycemic events after discontinuing the study for subjects who did not remain in the study until Month 25.|negative binomial regression|||The number of hypoglycemia events during the study was analyzed using a negative binomial regression model, with number of events as the dependent variable, and treatment, age, baseline daily insulin dose, and baseline C-peptide as covariates. The log of duration in the study for each patient was used as an offset variable in the model.||0.79|-0.02|0.07
73920751|NCT01346839|147369676|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Cox|||||||<0.05
73920752|NCT01199289|147369767|SUPERIORITY||LS Mean Difference|-0.068||||0.5838|TWO_SIDED|95.0|-0.311|0.175|||ANCOVA|||||0.175|-0.311|0.5838
73920753|NCT01199289|147369767|SUPERIORITY||LS Mean Difference|-0.075||||0.5391|TWO_SIDED|95.0|-0.316|0.166|||ANCOVA|||||0.166|-0.316|0.5391
73920754|NCT01199289|147369767|SUPERIORITY||LS Mean Difference|-0.113||||0.3583|TWO_SIDED|95.0|-0.355|0.129|||ANCOVA|||||0.129|-0.355|0.3583
73920755|NCT01199289|147369768|SUPERIORITY||LS Mean Difference|-0.047||||0.4076|TWO_SIDED|95.0|-0.157|0.064|||ANCOVA|||Pre-Bronchodilator||0.064|-0.157|0.4076
73920756|NCT01199289|147369768|SUPERIORITY||LS Mean Difference|-0.022||||0.6915|TWO_SIDED|95.0|-0.13|0.086|||ANCOVA|||Pre-Bronchodilator||0.086|-0.130|0.6915
73920757|NCT01199289|147369768|SUPERIORITY||LS Mean Difference|-0.019||||0.7271|TWO_SIDED|95.0|-0.126|0.088|||ANCOVA|||Pre-Bronchodilator||0.088|-0.126|0.7271
73920758|NCT01199289|147369768|SUPERIORITY||LS Mean Difference|0.005||||0.921|TWO_SIDED|95.0|-0.086|0.095|||ANCOVA|||Post-Bronchodilator||0.095|-0.086|0.9210
73920759|NCT01199289|147369768|SUPERIORITY||LS Mean Difference|0.07||||0.1139|TWO_SIDED|95.0|-0.017|0.157|||ANCOVA|||Post-Bronchodilator||0.157|-0.017|0.1139
73920760|NCT01199289|147369768|SUPERIORITY||LS Mean Difference|0.021||||0.6426|TWO_SIDED|95.0|-0.066|0.107|||ANCOVA|||Post-Bronchodilator||0.107|-0.066|0.6426
73920761|NCT01199289|147369769|SUPERIORITY||LS Mean Difference|-16.847||||0.0262|TWO_SIDED|95.0|-31.686|-2.009|||ANCOVA|||AM||-2.009|-31.686|0.0262
73920762|NCT01199289|147369769|SUPERIORITY||LS Mean Difference|-6.723||||0.3627|TWO_SIDED|95.0|-21.239|7.793|||ANCOVA|||AM||7.793|-21.239|0.3627
73920763|NCT01199289|147369769|SUPERIORITY||LS Mean Difference|-5.488||||0.4507|TWO_SIDED|95.0|-19.791|8.814|||ANCOVA|||AM||8.814|-19.791|0.4507
73920764|NCT01199289|147369769|SUPERIORITY||LS Mean Difference|-10.426||||0.1228|TWO_SIDED|95.0|-23.686|2.834|||ANCOVA|||PM||2.834|-23.686|0.1228
73920765|NCT01199289|147369769|SUPERIORITY||LS Mean Difference|-6.738||||0.3092|TWO_SIDED|95.0|-19.758|6.281|||ANCOVA|||PM||6.281|-19.758|0.3092
73920766|NCT01199289|147369769|SUPERIORITY||LS Mean Difference|-8.043||||0.2167|TWO_SIDED|95.0|-20.831|4.744|||ANCOVA|||PM||4.744|-20.831|0.2167
73920767|NCT01199289|147369770|SUPERIORITY||LS Mean Difference|0.331||||0.5157|TWO_SIDED|95.0|-0.67|1.332|||ANCOVA|||||1.332|-0.670|0.5157
73920768|NCT01199289|147369770|SUPERIORITY||LS Mean Difference|-0.234||||0.6434|TWO_SIDED|95.0|-1.229|0.76|||ANCOVA|||||0.760|-1.229|0.6434
73920769|NCT01199289|147369770|SUPERIORITY||LS Mean Difference|-0.199||||0.6954|TWO_SIDED|95.0|-1.196|0.799|||ANCOVA|||||0.799|-1.196|0.6954
73920770|NCT01199289|147369771|SUPERIORITY||LS Mean Difference|-0.283||||0.5577|TWO_SIDED|95.0|-1.231|0.665|||ANCOVA|||||0.665|-1.231|0.5577
73920771|NCT01199289|147369771|SUPERIORITY||LS Mean Difference|0.038||||0.9366|TWO_SIDED|95.0|-0.904|0.98|||ANCOVA|||||0.980|-0.904|0.9366
73920772|NCT01199289|147369771|SUPERIORITY||LS Mean Difference|0.138||||0.7745|TWO_SIDED|95.0|-0.808|1.084|||ANCOVA|||||1.084|-0.808|0.7745
73920773|NCT01199289|147369772|SUPERIORITY||LS Mean Difference|0.026||||0.8524|TWO_SIDED|95.0|-0.251|0.303|||ANCOVA|||||0.303|-0.251|0.8524
73920774|NCT01199289|147369772|SUPERIORITY||LS Mean Difference|-0.033||||0.8139|TWO_SIDED|95.0|-0.305|0.24|||ANCOVA|||||0.240|-0.305|0.8139
73920775|NCT01199289|147369772|SUPERIORITY||LS Mean Difference|-0.002||||0.9881|TWO_SIDED|95.0|-0.281|0.276|||ANCOVA|||||0.276|-0.281|0.9881
73920776|NCT01199289|147369773|SUPERIORITY|With use of SABA|LS Mean Difference|-0.062||||0.1213|TWO_SIDED|95.0|-0.141|0.017|||ANCOVA|||||0.017|-0.141|0.1213
73920777|NCT01199289|147369773|SUPERIORITY|With use of SABA|LS Mean Difference|-0.017||||0.6643|TWO_SIDED|95.0|-0.095|0.061|||ANCOVA|||||0.061|-0.095|0.6643
73920778|NCT01199289|147369773|SUPERIORITY||LS Mean Difference|-0.042||||0.2879|TWO_SIDED|95.0|-0.121|0.036|||ANCOVA|With use of SABA||||0.036|-0.121|0.2879
73920779|NCT01199289|147369773|SUPERIORITY|Without use of SABA|LS Mean Difference|-0.074||||0.0546|TWO_SIDED|95.0|-0.15|0.001|||ANCOVA|||||0.001|-0.150|0.0546
73920780|NCT01199289|147369773|SUPERIORITY||LS Mean Difference|-0.004||||0.9078|TWO_SIDED|95.0|-0.08|0.071|||ANCOVA|||Without use of SABA||0.071|-0.080|0.9078
73920781|NCT01199289|147369773|SUPERIORITY||LS Mean Difference|-0.035||||0.3616|TWO_SIDED|95.0|-0.111|0.04|||ANCOVA|||Without use of SABA||0.040|-0.111|0.3616
73920782|NCT02723084|147369777|NON_INFERIORITY|The percentage of participants achieving SVR12 was calculated for each arm and a 2- sided 95% confidence interval (CI) for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the CI for the difference was above the noninferiority margin of -10%, then arm A was considered non-inferior to arm B.|Risk Difference (RD)|4.3|||||TWO_SIDED|95.0|-3.5|12.1|||||95% CI was calculated using the normal approximation to the binomial distribution.|Difference in SVR12 rates (Arm A - Arm B)||12.1|-3.5|
73920783|NCT00127712|147369792|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
73920784|NCT00127712|147369793|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
73920785|NCT00127712|147369794|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
73920786|NCT00127712|147369795|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
73920787|NCT02642614|147369797|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.59|STANDARD_ERROR_OF_MEAN|0.51||0.154|TWO_SIDED|90.0|0.93|2.72|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 5 milligram BI 1026706 divided by Placebo."|Adjusted means were calculated by exponentiating Least Square (LS) means of corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive pharmacokinetic (PK) sub-study participation and Multiple-breath washout (MBW) sub-study participation)||2.72|0.93|0.1540
74088485|NCT01286558|147730334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||||95.0|-2.58|0.15|||ANCOVA|||||0.15|-2.58|
73920788|NCT02642614|147369797|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.58|STANDARD_ERROR_OF_MEAN|0.49||0.143|TWO_SIDED|90.0|0.94|2.65|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 25 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)||2.65|0.94|0.1430
73920789|NCT02642614|147369797|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.44|STANDARD_ERROR_OF_MEAN|0.45||0.2398|TWO_SIDED|90.0|0.86|2.41|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 100 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)||2.41|0.86|0.2398
73920790|NCT02328755|147369852|OTHER|Single group|cumulative incidence|0.39|||||TWO_SIDED|95.0|0.24|0.58||||||The analysis applies only to the first row, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).||0.58|0.24|
73920791|NCT02328755|147369853|OTHER|Single group|Kaplan-Meier|55.0|||||TWO_SIDED|95.0|40.0|75.0||||||The analysis applies only to the first row, data at 6 months, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).|Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|75|40|
73920792|NCT02328755|147369853|OTHER|Single group|Kaplan-Meier|33.0|||||TWO_SIDED|95.0|19.0|58.0||||||The analysis applies only to the 3rd row, data at 24 months, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).|Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|58|19|
73920793|NCT02328755|147369854|OTHER|Single group|||||||||||||||||Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|||
73920794|NCT02328755|147369855|OTHER|Single group|||||||||||||||||GVHD proportion estimates and corresponding 95% confidence intervals were calculated using methods of Fine and Gray.|||
73920795|NCT02328755|147369856|OTHER|Single group|||||||||||||||||Non-relapse mortality estimates and corresponding 95% confidence intervals were calculated using methods of Fine and Gray.|||
73920796|NCT05022784|147369858|OTHER||||||<|0.0001|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compares the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||<.0001
73920797|NCT05022784|147369859|OTHER||||||<|0.0001|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||<.0001
73920798|NCT05022784|147369860|OTHER|||||||0.37|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.37
73920799|NCT05022784|147369861|OTHER|||||||0.477|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.477
73920800|NCT05022784|147369862|OTHER|||||||0.644|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.644
73920801|NCT05022784|147369863|OTHER|||||||0.206|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.206
73920802|NCT05022784|147369864|OTHER|||||||0.052|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.052
73920803|NCT05022784|147369865|OTHER|||||||0.044|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.044
73920804|NCT05022784|147369866|OTHER|||||||0.525|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.525
74088486|NCT01286558|147730335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||||95.0|-4.16|0.35|||ANCOVA|||||0.35|-4.16|
73920805|NCT05022784|147369867|OTHER|||||||0.024|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.024
73920806|NCT05022784|147369868|OTHER|||||||0.016|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.016
73920807|NCT05022784|147369869|OTHER|||||||0.913|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.913
73920808|NCT05022784|147369870|OTHER|||||||0.448|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.448
73920809|NCT05022784|147369871|OTHER|||||||0.515|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.515
73920810|NCT05022784|147369872|OTHER|||||||0.829|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.829
73920811|NCT05022784|147369873|OTHER|||||||0.471|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.471
74088487|NCT01286558|147730336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||||95.0|-2.57|0.79|||ANCOVA|||||0.79|-2.57|
74088488|NCT01286558|147730337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||||95.0|-4.27|0.99|||ANCOVA|||||0.99|-4.27|
73920812|NCT05022784|147369874|OTHER|||||||0.915|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.915
73920813|NCT05022784|147369875|OTHER|||||||0.19|||||||Chi-squared|||||||0.190
73920814|NCT05022784|147369876|OTHER|||||||0.928|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.928
73920815|NCT05022784|147369877|OTHER|||||||0.49|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.490
73920816|NCT05022784|147369878|OTHER|||||||0.667|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.667
73920817|NCT05022784|147369879|OTHER|||||||0.032|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.032
74028095|NCT01380093|147610077|SUPERIORITY_OR_OTHER||LS Mean Difference|325.8|||<|0.0001|TWO_SIDED|95.0|290.8|360.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||360.7|290.8|<0.0001
73920818|NCT05022784|147369880|OTHER|||||||0.721|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.721
73920819|NCT05022784|147369881|OTHER|||||||0.352|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.352
74028096|NCT01380093|147610078|SUPERIORITY_OR_OTHER||LS Mean Difference|-268.2|||<|0.0001|TWO_SIDED|95.0|-313.2|-223.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-223.2|-313.2|<0.0001
73920820|NCT05022784|147369882|OTHER|||||||0.136|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.136
73920821|NCT05022784|147369883|OTHER|||||||0.27|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.270
73920822|NCT05022784|147369884|OTHER|||||||0.306|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.306
73920823|NCT05022784|147369885|OTHER|||||||0.145|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.145
73920824|NCT05022784|147369886|OTHER|||||||0.109|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.109
73920825|NCT05022784|147369887|OTHER|||||||0.454|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.454
73920826|NCT05022784|147369888|OTHER|||||||0.96|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.960
73920827|NCT05022784|147369889|OTHER|||||||0.265|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.265
73920828|NCT05022784|147369890|OTHER|||||||0.026|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.026
73920829|NCT05022784|147369891|OTHER|||||||0.016|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.016
73920830|NCT05022784|147369892|OTHER|||||||0.937|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.937
73920831|NCT05022784|147369893|OTHER|||||||0.948|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.948
74028097|NCT01380093|147610078|SUPERIORITY_OR_OTHER||LS Mean Difference|147.0|||<|0.0001|TWO_SIDED|95.0|102.1|191.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||191.9|102.1|<0.0001
74028098|NCT01380093|147610078|SUPERIORITY_OR_OTHER||LS Mean Difference|415.2|||<|0.0001|TWO_SIDED|95.0|370.2|460.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||460.2|370.2|<0.0001
74088489|NCT01272921|147730369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|||<|0.001|TWO_SIDED|95.0|0.49|0.54|||Z score|||||0.54|0.49|<0.001
74088490|NCT01272921|147730369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.18|0.21|||Z score|||||0.21|0.18|<0.001
73920832|NCT05022784|147369894|OTHER|||||||0.574|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.574
73920833|NCT05022784|147369895|OTHER|||||||0.491|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.491
73920834|NCT05022784|147369896|OTHER|||||||0.432|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.432
73920835|NCT00708162|147369903|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the EVG group was at least 10% worse than the RAL group with respect to percentage of participants achieving and maintaining HIV-1 RNA \< 50 copies/mL through Week 48; alternative hypothesis: the EVG group was less than 10% worse than the RAL group.|Difference in percentages|1.1|||||TWO_SIDED|95.0|-6.0|8.2|||||The difference in percentages and its 95% confidence interval (CI) were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using Mantel-Haenszel (MH) proportions and normal approximation.|The planned sample size of 700 HIV-1 infected participants, (350 in each group) was estimated to provide at least 85% power to establish noninferiority in the percentage of participants achieving and maintaining confirmed HIV-1 RNA \< 50 copies/mL through Week 48. For sample size and power computation, it was assumed that both elvitegravir and raltegravir arms have a response rate of 0.74, that a noninferiority margin was 0.10, and that the significance level of the test was 1-sided 0.025 level.||8.2|-6.0|
73920836|NCT00708162|147369904|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the EVG arm was at least 10% worse than the RAL arm with respect to percentage of participants achieving and maintaining HIV-1 RNA \< 50 copies/mL through Week 48; alternative hypothesis: the EVG arm was less than 10% worse than the RAL arm.|Difference in percentages|2.6|||||TWO_SIDED|95.0|-4.6|9.9|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||9.9|-4.6|
73920837|NCT00708162|147369905|SUPERIORITY_OR_OTHER||Difference in percentages|0.9|||||TWO_SIDED|95.0|-6.0|7.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||7.7|-6.0|
74028099|NCT01380093|147610079|SUPERIORITY_OR_OTHER||LS Mean Difference|-336.0|||<|0.0001|TWO_SIDED|95.0|-395.4|-276.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-276.6|-395.4|<0.0001
74028100|NCT01380093|147610079|SUPERIORITY_OR_OTHER||LS Mean Difference|165.6|||<|0.0001|TWO_SIDED|95.0|106.4|224.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||224.8|106.4|<0.0001
73920838|NCT00708162|147369906|SUPERIORITY_OR_OTHER||Difference in percentages|0.9|||||TWO_SIDED|95.0|-6.4|8.2|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||8.2|-6.4|
74028101|NCT01380093|147610079|SUPERIORITY_OR_OTHER||LS Mean Difference|501.6|||<|0.0001|TWO_SIDED|95.0|442.2|561.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||561.0|442.2|<0.0001
74028102|NCT01380093|147610080|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.8|||<|0.0001|TWO_SIDED|95.0|-40.7|-26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-26.8|-40.7|<0.0001
74028103|NCT01380093|147610080|SUPERIORITY_OR_OTHER||LS Mean Difference|26.7|||<|0.0001|TWO_SIDED|95.0|19.7|33.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.6|19.7|<0.0001
73920839|NCT00708162|147369907|SUPERIORITY_OR_OTHER||Difference in percentages|2.2|||||TWO_SIDED|95.0|-5.0|9.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||9.3|-5.0|
74028104|NCT01380093|147610080|SUPERIORITY_OR_OTHER||LS Mean Difference|60.4|||<|0.0001|TWO_SIDED|95.0|53.4|67.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||67.4|53.4|<0.0001
74028105|NCT01380093|147610081|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.3345|TWO_SIDED|95.0|-0.4|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.3|-0.4|0.3345
74028106|NCT01380093|147610081|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|||<|0.0001|TWO_SIDED|95.0|1.5|3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.3|1.5|<0.0001
74028107|NCT01380093|147610081|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.1|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.1|<0.0001
74028108|NCT01380093|147610082|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.0453|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.0|-2.0|0.0453
74028109|NCT01380093|147610082|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.5637|TWO_SIDED|95.0|-0.7|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.3|-0.7|0.5637
73920840|NCT00708162|147369908|SUPERIORITY_OR_OTHER||Difference in percentages|-0.5|||||TWO_SIDED|95.0|-7.9|6.8|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||6.8|-7.9|
73920841|NCT00708162|147369913|SUPERIORITY_OR_OTHER||Difference in percentages|0.2|||||TWO_SIDED|95.0|-6.9|7.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||7.3|-6.9|
73920842|NCT00708162|147369914|SUPERIORITY_OR_OTHER||Difference in percentages|-2.9|||||TWO_SIDED|95.0|-10.2|4.4|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||4.4|-10.2|
73920843|NCT00708162|147369915|SUPERIORITY_OR_OTHER||Difference in percentages|-2.0|||||TWO_SIDED|95.0|-8.6|4.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||4.7|-8.6|
73920844|NCT00708162|147369916|SUPERIORITY_OR_OTHER||Difference in percentages|-1.7|||||TWO_SIDED|95.0|-8.8|5.5|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||5.5|-8.8|
73920845|NCT00708162|147369917|SUPERIORITY_OR_OTHER||Difference in log10 copies/mL|0.01|||||TWO_SIDED|95.0|-0.16|0.19|||||The difference in least squares means (LSM) and its 95% CI were obtained using an analysis of variance model (ANOVA) adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||0.19|-0.16|
73920846|NCT00708162|147369918|SUPERIORITY_OR_OTHER||Difference in log10 copies/mL|0.05|||||TWO_SIDED|95.0|-0.12|0.22|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||0.22|-0.12|
73920847|NCT00708162|147369919|SUPERIORITY_OR_OTHER||Difference in cells/mm^3|-9.0|||||TWO_SIDED|95.0|-33.0|16.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||16|-33|
73920848|NCT00708162|147369920|SUPERIORITY_OR_OTHER||Difference in cells/mm^3|7.0|||||TWO_SIDED|95.0|-25.0|39.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||39|-25|
73920849|NCT00708643|147369925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0047|STANDARD_ERROR_OF_MEAN|2.2863|||TWO_SIDED|98.75|-3.0047|2.7153|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A will provide a lower level of limbal hyperemia than the habitual lens.||2.7153|-3.0047|
73920850|NCT00708643|147369926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0804|STANDARD_ERROR_OF_MEAN|0.7605|||TWO_SIDED|99.0|-0.0804|1.8821|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides better comfort than the habitual lens by having a lower rating on the scale.||1.8821|-0.0804|
73920851|NCT00708643|147369927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2228|STANDARD_ERROR_OF_MEAN|1.7002|||TWO_SIDED|99.0|0.2228|4.6564|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A provides a lowe level of upper lid margin staining than the habitual lens.||4.6564|0.2228|
73920852|NCT00708643|147369928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2596|STANDARD_ERROR_OF_MEAN|1.1873|||TWO_SIDED|98.75|1.2596|4.2599|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|||4.2599|1.2596|
73920853|NCT00708643|147369929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8625|STANDARD_ERROR_OF_MEAN|2.3407|||TWO_SIDED|98.75|-0.8625|5.0524|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides a lower level of tarsal hyperemia than the habitual lens.||5.0524|-0.8625|
73920854|NCT00708643|147369930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.241|STANDARD_ERROR_OF_MEAN|1.6975|||TWO_SIDED|98.75|-0.241|4.0043|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides lower levels of corneal staining than the habitual lens.||4.0043|-0.2410|
74086685|NCT03396874|147727006|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|100.0|||<|1e-07|TWO_SIDED|95.0|97.85|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, bone: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In bone, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|97.85|<0.0000001
73920855|NCT03720470|147370012|SUPERIORITY||Difference in percentage|23.1|||<|0.0001|TWO_SIDED|95.0|14.7|31.4|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||31.4|14.7|<0.0001
73920856|NCT03720470|147370012|SUPERIORITY||Difference in Percentage|34.8|||<|0.0001|TWO_SIDED|95.0|26.1|43.5|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.5|26.1|<0.0001
73920857|NCT03720470|147370013|SUPERIORITY||Difference in percentage|31.9|||<|0.0001|TWO_SIDED|95.0|22.2|41.6|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||41.6|22.2|<0.0001
74086686|NCT00588731|147727011|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.90
74086687|NCT00588731|147727012|SUPERIORITY_OR_OTHER|||||||0.76|||||||ANOVA|||||||0.76
73920858|NCT03720470|147370013|SUPERIORITY||Difference in Percentage|43.2|||<|0.0001|TWO_SIDED|95.0|33.7|52.7|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||52.7|33.7|<0.0001
73920859|NCT03720470|147370014|SUPERIORITY||Difference in percentage|17.9||||0.0002|TWO_SIDED|95.0|9.5|26.3|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||26.3|9.5|0.0002
74086688|NCT00346164|147727018|OTHER||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
73920860|NCT03720470|147370014|SUPERIORITY||Difference in Percentage|34.9|||<|0.0001|TWO_SIDED|95.0|26.0|43.7|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.7|26.0|<.0001
73920861|NCT03720470|147370014|SUPERIORITY||Difference in Percentage|5.2||||0.2084|TWO_SIDED|95.0|-2.9|13.4|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||13.4|-2.9|0.2084
73920862|NCT03720470|147370014|SUPERIORITY||Difference in Percentage|22.1|||<|0.0001|TWO_SIDED|95.0|13.5|30.7|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||30.7|13.5|<0.0001
73920863|NCT03720470|147370015|OTHER||Difference in Percentage|22.1|||<|0.0001|TWO_SIDED|95.0|13.7|30.5|||Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||30.5|13.7|<0.0001
73920864|NCT03720470|147370015|OTHER||Difference in Percentage|35.0|||<|0.0001|TWO_SIDED|95.0|26.3|43.7|||Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.7|26.3|<0.0001
73920865|NCT03720470|147370015|OTHER||Difference in Percentage|-3.5|||||TWO_SIDED|95.0|-12.2|5.2||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||5.2|-12.2|
73920866|NCT03720470|147370015|OTHER||Difference in Percentage|9.4|||||TWO_SIDED|95.0|0.4|18.5||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||18.5|0.4|
73920867|NCT03720470|147370016|OTHER||Difference in percentage|24.1|||<|0.0001|TWO_SIDED|95.0|14.0|34.1|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||34.1|14.0|<0.0001
73920868|NCT03720470|147370016|OTHER||Difference in Percentage|30.1|||<|0.0001|TWO_SIDED|95.0|20.3|39.8|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||39.8|20.3|<0.0001
73920869|NCT03720470|147370016|OTHER||Difference in Percentage|-2.7|||||TWO_SIDED|95.0|-9.6|4.2||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||4.2|-9.6|
73920870|NCT03720470|147370016|OTHER||Difference in Percentage|3.1|||||TWO_SIDED|95.0|-3.3|9.6||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||9.6|-3.3|
74086689|NCT00346164|147727019|OTHER|||||||0.0049|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .||||0.0049
74086690|NCT00346164|147727020|OTHER||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
74028110|NCT01380093|147610082|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.011|TWO_SIDED|95.0|0.3|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.3|0.3|0.0110
74028111|NCT01380093|147610083|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.9||||0.0041|TWO_SIDED|95.0|-8.2|-1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.6|-8.2|0.0041
73920871|NCT00453921|147370043|OTHER||||||<|0.04||||||For active therapy/placebo relative to both placebo|Kruskal-Wallis|||||||<0.04
73920872|NCT00453921|147370045|EQUIVALENCE|Looking for statistical difference, p \< .01, between groups looking at change scores|||||<|0.05|||||||ANOVA|||||||<0.05
73920873|NCT00453921|147370046|EQUIVALENCE|group differences|||||<|0.05|||||||ANCOVA|||||||<0.05
73920874|NCT00453921|147370049|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
73920875|NCT00453921|147370049|SUPERIORITY||||||<|0.05||||||a priopr|ANCOVA|||||||<0.05
73920876|NCT00530764|147370064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.33|TWO_SIDED|95.0|0.72|2.6|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each of the Sativex treatment groups and placebo. The estimated response rates, odds ratios, 95% CIs for the odds ratios and p-values were presented.||2.60|0.72|0.33
73920877|NCT00530764|147370064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.62|TWO_SIDED|95.0|0.46|1.76|||Regression, Logistic|||As for Sativex Low dose versus placebo||1.76|0.46|0.62
73920878|NCT00530764|147370064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.61|TWO_SIDED|95.0|0.62|2.28|||Regression, Logistic|||As for Sativex Low dose versus placebo||2.28|0.62|0.61
73920879|NCT00530764|147370065|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.5||||0.0077|TWO_SIDED|95.0|-21.35|-3.33|||Wilcoxon rank sum tests|||Each of the active treatment groups were compared with placebo using pairwise Wilcoxon rank-sum tests. The Hodges-Lehmann estimates and 95% CI for the median differences were also presented.||-3.33|-21.35|0.0077
73920880|NCT00530764|147370065|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.97||||0.67|TWO_SIDED|95.0|-11.04|7.14|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo||7.14|-11.04|0.67
73920881|NCT00530764|147370065|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.75||||0.039|TWO_SIDED|95.0|-17.14|0.0|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo||0.00|-17.14|0.039
73920882|NCT00530764|147370066|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.75||||0.006|TWO_SIDED|95.0|-1.28|-0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors.||-0.22|-1.28|0.006
73920883|NCT00530764|147370066|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.09||||0.75|TWO_SIDED|95.0|-0.62|0.44|||ANCOVA|||As for Sativex low dose versus placebo||0.44|-0.62|0.75
73920884|NCT00530764|147370066|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.36||||0.19|TWO_SIDED|95.0|-0.89|0.18|||ANCOVA|||As for Sativex low dose versus placebo||0.18|-0.89|0.19
73920885|NCT00530764|147370067|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.73||||0.011|TWO_SIDED|95.0|-1.3|-0.17|||ANCOVA|||The change in mean pain NRS score (worst pain) was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.||-0.17|-1.30|0.011
73920886|NCT00530764|147370067|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.35||||0.14|TWO_SIDED|95.0|-0.81|0.11|||ANCOVA|||As for Sativex low dose versus placebo||0.11|-0.81|0.14
73920887|NCT00530764|147370067|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.24||||0.4|TWO_SIDED|95.0|-0.81|0.32|||ANCOVA|||As for Sativex low dose versus placebo||0.32|-0.81|0.40
73920888|NCT00530764|147370068|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.88||||0.003|TWO_SIDED|95.0|-1.45|-0.31|||ANCOVA|||The change in mean sleep disturbance NRS score was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.||-0.31|-1.45|0.003
73920889|NCT00530764|147370068|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.08||||0.78|TWO_SIDED|95.0|-0.65|0.49|||ANCOVA|||As for Sativex low dose versus placebo||0.49|-0.65|0.78
73920890|NCT00530764|147370068|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.33||||0.26|TWO_SIDED|95.0|-0.9|0.24|||ANCOVA|||As for Sativex low dose versus placebo.||0.24|-0.90|0.26
73920891|NCT00467259|147370078|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
73920892|NCT00467259|147370079|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
74028112|NCT01380093|147610083|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.2178|TWO_SIDED|95.0|-1.2|5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.3|-1.2|0.2178
74028113|NCT01380093|147610083|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0|||<|0.0001|TWO_SIDED|95.0|3.7|10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||10.3|3.7|<0.0001
73920893|NCT00467259|147370080|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's Exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
74028114|NCT01380093|147610084|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.4||||0.0001|TWO_SIDED|95.0|-28.8|-9.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.9|-28.8|0.0001
73920894|NCT00828347|147370088|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Fisher Exact|||||||0.036
73920895|NCT01129960|147370089|SUPERIORITY_OR_OTHER|||||||0.3726|||||||Dunnett's test (analysis of covariance)|||||||0.3726
73920896|NCT01129960|147370089|SUPERIORITY_OR_OTHER|||||||0.8034|||||||Dunnett's test (analysis of covariance)|||||||0.8034
73920897|NCT01129960|147370089|SUPERIORITY_OR_OTHER|||||||0.1391|||||||Dunnett's test (analysis of covariance)|||||||0.1391
73920898|NCT02056340|147370095|OTHER|||||||0.611||||||Threshold for significaance was p value \<0.05.|Mixed Models Analysis|||We used a linear mixed-effects model which accounted for all measurements taken and the time that those measurements were taken.||||0.611
73920899|NCT02056340|147370096|OTHER|||||||0.029||||||P value reflects baseline to 72 hours between groups. A p-value \<0.05 will be considered significant.|Mixed Models Analysis|||The primary comparison was at 72 hours for the self-reported influenza severity score.||||0.029
73920900|NCT00775645|147370143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.17|TWO_SIDED|95.0|-2.2|0.4|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||0.4|-2.2|0.17
73920901|NCT00775645|147370144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.92|TWO_SIDED|95.0|-3.0|2.7|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||2.7|-3|0.92
73920902|NCT00775645|147370145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2|TWO_SIDED|95.0|-0.7|3.3|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||3.3|-0.7|0.20
73920903|NCT00775645|147370146|SUPERIORITY|||||||0.46|||||||Regression, Linear|Adjusted for randomization stratification factors.||||||0.46
73920904|NCT03194698|147370172|SUPERIORITY|||||||0.0312|||||||Wilcoxon (Mann-Whitney)|||||||0.0312
73920905|NCT03194698|147370173|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
73920906|NCT03194698|147370174|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
73920907|NCT00665847|147370186|SUPERIORITY_OR_OTHER||Proportion|52.5|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|42.7|62.2|||||The standard error for a proportion was calculated as the square root of the variance divided by the number of patients. The variance for a proportion is equal to p\*(1-p), with p being the proportion.|||62.2|42.7|
73920908|NCT03388294|147370192|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|7.32||||0.028|TWO_SIDED||||||Mixed Models Analysis|||||||0.028
73920909|NCT03388294|147370193|OTHER||Mean Difference (Net)|12.75|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||The focus for this analysis is change over time||||<0.001
73920910|NCT03388294|147370194|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||||||0.87
73920911|NCT03388294|147370195|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.61||||0.006|TWO_SIDED||||||Mixed Models Analysis|||||||0.006
73920912|NCT03388294|147370196|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
73920913|NCT03388294|147370197|OTHER|The focus for this analysis is change over time||||||0.849|||||||Mixed Models Analysis|||||||0.849
73920914|NCT03388294|147370198|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.2||||0.063|TWO_SIDED||||||Mixed Models Analysis|||||||0.063
73920915|NCT03388294|147370199|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.48|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73920916|NCT03388294|147370203|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|-2.9||||0.036|TWO_SIDED||||||Mixed Models Analysis|||||||0.036
73920917|NCT03388294|147370204|OTHER|The focus for this analysis is change over time||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
73920918|NCT03388294|147370205|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.36||||0.864|TWO_SIDED||||||Mixed Models Analysis|||||||0.864
73920919|NCT03388294|147370206|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|3.14||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
73920920|NCT03388294|147370207|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.02||||0.881|TWO_SIDED||||||Mixed Models Analysis|||||||0.881
74028115|NCT01380093|147610084|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.151|TWO_SIDED|95.0|-2.6|16.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||16.3|-2.6|0.1510
74028116|NCT01380093|147610084|SUPERIORITY_OR_OTHER||LS Mean Difference|26.2|||<|0.0001|TWO_SIDED|95.0|16.8|35.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||35.7|16.8|<0.0001
74028117|NCT01380093|147610085|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|95.0|-75.9|-34.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-34.4|-75.9|<0.0001
74028118|NCT01380093|147610085|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||0.0796|TWO_SIDED|95.0|-2.2|39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||39.2|-2.2|0.0796
73920921|NCT03388294|147370208|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.02||||0.846|TWO_SIDED||||||Mixed Models Analysis|||||||0.846
73920922|NCT03143569|147370219|OTHER|||||||0.45|||||||Fisher Exact|||||||.45
73920923|NCT03143569|147370220|OTHER|||||||1|||||||Fisher Exact|||||||1.0
73920924|NCT03143569|147370221|OTHER|||||||1|||||||Fisher Exact|||||||1.0
73920925|NCT03143569|147370222|OTHER|||||||1|||||||Fisher Exact|||||||1.0
73920926|NCT03143569|147370223|OTHER|||||||0.018|||||||Chi-squared|||||||.018
73931013|NCT01462357|147391797|NON_INFERIORITY|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.23|||||TWO_SIDED|95.0|0.2|0.26|||ANOVA|||Immune response to anti-HPV-18 in terms of GMT: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||0.26|0.20|
73931014|NCT01462357|147391798|SUPERIORITY|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-18 antibodies.|GMT ratio|4.52||||0.0001|TWO_SIDED|95.0|3.97|5.13|||ANOVA|||Anti-HPV-18 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.||5.13|3.97|0.0001
73931015|NCT01462357|147391798|SUPERIORITY|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-16 antibodies.|GMT ratio|1.69||||0.0001|TWO_SIDED|95.0|1.49|1.91|||ANOVA|||Anti-HPV-16 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.||1.91|1.49|0.0001
73931016|NCT00025883|147391828|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within GLD group.||||<0.001
73931017|NCT00025883|147391828|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within PLD group.||||0.004
73931018|NCT00025883|147391829|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within GLD group.||||0.05
73931019|NCT00025883|147391829|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within PLD group.||||0.02
73931020|NCT02908529|147391843|SUPERIORITY||Median Difference (Final Values)|-15.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73931021|NCT05569954|147391860|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-1.6|||||TWO_SIDED|95.0|-4.0|0.7|||||V116 minus PPSV23|Injection site erythema: estimated difference in percent||0.7|-4.0|
73931022|NCT05569954|147391860|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|3.7|||||TWO_SIDED|95.0|-1.2|8.7|||||V116 minus PPSV23|Injection site pain: estimated difference in percent||8.7|-1.2|
73931023|NCT05569954|147391860|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.6|||||TWO_SIDED|95.0|-1.6|2.7|||||V116 minus PPSV23|Injection site swelling: estimated difference in percent||2.7|-1.6|
73931024|NCT05569954|147391861|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.9|||||TWO_SIDED|95.0|-2.9|4.6|||||V116 minus PPSV23|Fatigue: estimated difference in percent||4.6|-2.9|
73931025|NCT05569954|147391861|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|1.7||||||95.0|-1.8|5.1|||||V116 minus PPSV23|Headache: estimated difference in percent||5.1|-1.8|
73931026|NCT05569954|147391861|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-0.7||||||95.0|-3.1|1.7|||||V116 minus PPSV23|Myalgia: estimated difference in percent||1.7|-3.1|
73931027|NCT05569954|147391861|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-0.3||||||95.0|-1.5|0.9|||||V116 minus PPSV23|Pyrexia: estimated difference in percent||0.9|-1.5|
73931028|NCT05569954|147391862|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.0||||||95.0|-0.5|0.5|||||V116 minus PPSV23|Vaccine-Related Serious Adverse Events||0.5|-0.5|
73931029|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.23||1-sided|cLDA model||V116/PPSV23|Serotype 3: V116/PPSV23 GMT Ratio||1.23|0.96|<0.001
73931030|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.47|||<|0.001|TWO_SIDED|95.0|1.29|1.68||1-sided|cLDA model||V116/PPSV23|Serotype 7F: V116/PPSV23 GMT Ratio||1.68|1.29|<0.001
73931031|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.17|||<|0.001|TWO_SIDED|95.0|1.04|1.32||1-sided|cLDA model||V116/PPSV23|Serotype 8: V116/PPSV23 GMT Ratio||1.32|1.04|<0.001
74028119|NCT01380093|147610085|SUPERIORITY_OR_OTHER||LS Mean Difference|73.6|||<|0.0001|TWO_SIDED|95.0|52.9|94.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||94.4|52.9|<0.0001
74028120|NCT01380093|147610086|SUPERIORITY_OR_OTHER||LS Mean Difference|-82.8|||<|0.0001|TWO_SIDED|95.0|-112.9|-52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-52.7|-112.9|<0.0001
73920927|NCT01705288|147370256|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis||||0.36
73920928|NCT01705288|147370257|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis||||0.05
73920929|NCT01705288|147370258|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
73920930|NCT00501293|147370269|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.028
73920931|NCT00501293|147370269|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||<0.001
73920932|NCT00501293|147370270|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.027
73920933|NCT00501293|147370270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||<0.001
73920934|NCT00501293|147370273|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.071
73920935|NCT00501293|147370273|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||0.017
73920936|NCT03316131|147370286|OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|-8.67|9.22||||||||9.22|-8.67|
73920937|NCT03316131|147370287|OTHER||Geometric mean ratio|1.14|||||TWO_SIDED|90.0|1.03|1.25||||||Treatment A/Treatment B, for Verinurad||1.25|1.03|
73920938|NCT03316131|147370287|OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.88|1.07||||||Treatment A/Treatment B, for M1||1.07|0.88|
73920939|NCT03316131|147370287|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.91|1.08||||||Treatment A/Treatment B, for M8||1.08|0.91|
73920940|NCT03316131|147370288|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad||1.13|1.00|
73920941|NCT03316131|147370288|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||Treatment A/Treatment B, for M1||1.02|0.90|
73920942|NCT03316131|147370288|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8||1.04|0.94|
73920943|NCT03316131|147370292|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad||1.13|1.00|
73920944|NCT03316131|147370292|OTHER||Geometric mean ratio|0.96||||||90.0|0.9|1.02||||||Treatment A/Treatment B, for M1||1.02|0.90|
73920945|NCT03316131|147370292|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8||1.04|0.94|
73920946|NCT01409564|147370293|SUPERIORITY_OR_OTHER|||||||0.14|||||||Repeated ANOVA|Uncorrected, Repeated ANOVA||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Parietal Lobe in two groups on two data points (baseline, 24-week).||||0.14
73920947|NCT01409564|147370293|SUPERIORITY_OR_OTHER|||||||0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Parietal Lobe in two groups on two data points (baseline, 24-week).||||0.08
73920948|NCT01409564|147370293|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).||||<0.01
74028121|NCT01380093|147610086|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.078|TWO_SIDED|95.0|-3.1|56.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||56.9|-3.1|0.0780
74028122|NCT01380093|147610086|SUPERIORITY_OR_OTHER||LS Mean Difference|109.7|||<|0.0001|TWO_SIDED|95.0|79.6|139.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||139.8|79.6|<0.0001
74028123|NCT01380093|147610087|SUPERIORITY_OR_OTHER||LS Mean Difference|-111.9|||<|0.0001|TWO_SIDED|95.0|-153.7|-70.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-70.2|-153.7|<0.0001
73920949|NCT01409564|147370293|SUPERIORITY_OR_OTHER|||||||0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).||||0.08
73920950|NCT01409564|147370294|SUPERIORITY_OR_OTHER|||||||0.93|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of ADAS-Cog scores on three data points (Baseline, 12-week, 24-week)||||0.93
73920951|NCT01409564|147370295|SUPERIORITY_OR_OTHER|||||||0.15|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of MMSE scores on three data points (Baseline, 12-week, 24-week)||||0.15
73920952|NCT01409564|147370296|SUPERIORITY_OR_OTHER|||||||0.82|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of ADCS-ADL scores on three data points (Baseline, 12-week, 24-week)||||0.82
73920953|NCT01409564|147370297|SUPERIORITY_OR_OTHER|||||||0.79|||||||Chi-squared|||Repeated ANOVA, tested for group\*time interaction effect of Summed CDR scores on three data points (Baseline, 12-week, 24-week)||||0.79
73920954|NCT01409564|147370298|SUPERIORITY_OR_OTHER|||||||0.87|||||||Chi-squared|||Distribution of Fazekas scale in two groups according to Chi-square test results.||||0.87
73931032|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.12|||<|0.001||95.0|1.0|1.26||1-sided|cLDA model||V116/PPSV23|Serotype 9N: V116/PPSV23 GMT Ratio||1.26|1.00|<0.001
74028124|NCT01380093|147610087|SUPERIORITY_OR_OTHER||LS Mean Difference|33.9||||0.1089|TWO_SIDED|95.0|-7.8|75.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||75.5|-7.8|0.1089
73861461|NCT04411420|147268788|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.36|TWO_SIDED|95.0|-0.29|0.11|||Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.11|-0.29|0.360
73861462|NCT04411420|147268789|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.858|TWO_SIDED|95.0|-0.23|0.28||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.28|-0.23|0.858
73861463|NCT04411420|147268789|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.688|TWO_SIDED|95.0|-0.32|0.21||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.21|-0.32|0.688
73861464|NCT04411420|147268789|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.833|TWO_SIDED|95.0|-0.32|0.26||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.26|-0.32|0.833
73861465|NCT04411420|147268790|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.259|TWO_SIDED|95.0|-0.18|0.64||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.64|-0.18|0.259
73861466|NCT04411420|147268790|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.068|TWO_SIDED|95.0|-0.03|0.81||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.81|-0.03|0.068
73920955|NCT01042236|147370321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.88||0.4907|TWO_SIDED|95.0|-1.18|2.41||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||2.41|-1.18|0.4907
73920956|NCT01042236|147370321|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.88||0.5944|TWO_SIDED|95.0|-2.27|1.32||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.32|-2.27|0.5944
73920957|NCT01042236|147370322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.94||0.987|TWO_SIDED|95.0|-1.91|1.94||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.94|-1.91|0.9870
73920958|NCT01042236|147370322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.94||0.4167|TWO_SIDED|95.0|-2.71|1.15||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.15|-2.71|0.4167
73967433|NCT04556656|147472173|SUPERIORITY||Mean Difference (Final Values)|-22.72|STANDARD_ERROR_OF_MEAN|17.777||0.2024|TWO_SIDED|95.0|-57.72|12.28|||Mixed Models Analysis|||From baseline to Week 78.||12.28|-57.72|0.2024
73861467|NCT04411420|147268790|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.514|TWO_SIDED|95.0|-0.29|0.57||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.57|-0.29|0.514
73861468|NCT04411420|147268791|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.895|TWO_SIDED|95.0|-0.22|0.2||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.20|-0.22|0.895
73967434|NCT04556656|147472174|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.179||0.2088|TWO_SIDED|95.0|-0.13|0.58|||Mixed Models Analysis|||"From baseline to Week 26.~In the MMRM model, change in UHDRS-TFC score from baseline was the dependent variable and independent variables included treatment group, Baseline UHDRS-TFC, region, categorical week, Baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data."||0.58|-0.13|0.2088
73967435|NCT04556656|147472174|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.188||0.2991|TWO_SIDED|95.0|-0.17|0.57|||Mixed Models Analysis|||From baseline to Week 39.||0.57|-0.17|0.2991
73920959|NCT01042236|147370323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.12||0.9403|TWO_SIDED|95.0|-0.24|0.26||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.26|-0.24|0.9403
73920960|NCT01042236|147370323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.1881|TWO_SIDED|95.0|-0.42|0.09||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.09|-0.42|0.1881
73920961|NCT01042236|147370324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.8602|TWO_SIDED|95.0|-0.26|0.22||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.22|-0.26|0.8602
73920962|NCT01042236|147370324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1271|TWO_SIDED|95.0|-0.43|0.06||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.06|-0.43|0.1271
73920963|NCT00665353|147370407|SUPERIORITY_OR_OTHER||proportion|0.158||||0.29|ONE_SIDED|90.0|0.059|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.10. The hypothesized response rate was 0.30.|||0.059|0.29
73920964|NCT00665353|147370410|SUPERIORITY_OR_OTHER||proportion|0.053||||0.42|ONE_SIDED|90.0|0.001|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.02. The hypothesized response rate was 0.15.|||0.001|0.42
73920965|NCT02451839|147370418|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||< 0.001
73920966|NCT02451839|147370419|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920967|NCT02451839|147370420|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920968|NCT02451839|147370421|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920969|NCT02451839|147370422|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920970|NCT02451839|147370423|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920971|NCT02451839|147370424|SUPERIORITY|||||||0.015|||||||paired t-test|||||||0.015
73920972|NCT02451839|147370425|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920973|NCT02451839|147370426|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
73920974|NCT02451839|147370427|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920975|NCT02451839|147370428|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920976|NCT02451839|147370429|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
73920977|NCT02451839|147370430|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920978|NCT02451839|147370431|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920979|NCT02451839|147370432|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920980|NCT02451839|147370433|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73920981|NCT03103919|147370435|SUPERIORITY||Mean Difference (Final Values)|-4.31|||=|0.134|TWO_SIDED|95.0|-10.04|1.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||1.41|-10.04|=0.134
73920982|NCT03103919|147370436|SUPERIORITY||Mean Difference (Final Values)|0.01|||=|0.982|TWO_SIDED|95.0|-0.44|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.45|-0.44|=0.982
73920983|NCT03103919|147370437|SUPERIORITY||Mean Difference (Final Values)|-0.18|||=|0.566|TWO_SIDED|95.0|-0.81|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.45|-0.81|=0.566
73967436|NCT04556656|147472174|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.205||0.2116|TWO_SIDED|95.0|-0.15|0.66|||Mixed Models Analysis|||From baseline to Week 52.||0.66|-0.15|0.2116
73967437|NCT04556656|147472174|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.215||0.8242|TWO_SIDED|95.0|-0.38|0.47|||Mixed Models Analysis|||From baseline to Week 65.||0.47|-0.38|0.8242
73967438|NCT04556656|147472174|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.231||0.5918|TWO_SIDED|95.0|-0.33|0.58|||Mixed Models Analysis|||From baseline to Week 78.||0.58|-0.33|0.5918
74086691|NCT00346164|147727021|OTHER|||||||0.0096|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of the resection extent of the primary tumor (less than total resection; margin -; margin +) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), disease extent (non-metastatic; metastatic), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and histologic (POG) grade.||||0.0096
74086692|NCT00346164|147727022|OTHER||||||<|0.0001|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
74086693|NCT00346164|147727023|OTHER|||||||0.0228|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .||||0.0228
74086694|NCT00346164|147727025|OTHER||Kappa statistic|0.82|||||TWO_SIDED|95.0|0.76|0.88||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.||0.88|0.76|
74086695|NCT00346164|147727026|OTHER||Kappa statistic|0.42|||||TWO_SIDED|95.0|0.36|0.48||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.||0.48|0.36|
73861469|NCT04411420|147268791|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.438|TWO_SIDED|95.0|-0.13|0.3||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.30|-0.13|0.438
73861470|NCT04411420|147268791|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.89|TWO_SIDED|95.0|-0.24|0.21||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.21|-0.24|0.890
73920984|NCT03103919|147370438|SUPERIORITY||Mean Difference (Final Values)|-0.07|||=|0.72|TWO_SIDED|95.0|-0.5|0.35|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.35|-0.50|=0.720
73920985|NCT03103919|147370439|SUPERIORITY||Mean Difference (Final Values)|0.15|||=|0.443|TWO_SIDED|95.0|-0.24|0.53|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.53|-0.24|=0.443
73920986|NCT03103919|147370440|SUPERIORITY||Mean Difference (Final Values)|-0.09|||=|0.777|TWO_SIDED|95.0|-0.75|0.57|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.57|-0.75|=0.777
73967439|NCT04556656|147472175|SUPERIORITY||Mean Difference (Final Values)|3.16|STANDARD_ERROR_OF_MEAN|1.326||0.0178|TWO_SIDED|95.0|0.55|5.77|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in SWR score from baseline was the dependent variable and independent variables included treatment group, baseline SWR, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||5.77|0.55|0.0178
74086696|NCT01998243|147727127|SUPERIORITY||Risk Ratio (RR)|1.2||||0.689|TWO_SIDED|95.0|0.53|2.6|||Chi-squared||risk ratio (RR)|||2.60|0.53|0.689
74086697|NCT01998243|147727128|SUPERIORITY||Risk Ratio (RR)|1.59||||0.144|TWO_SIDED|95.0|0.84|3.01|||Chi-squared||all in all balloon and postsurgical morbidity in group A vs. group B.|||3.01|0.84|0.144
73920987|NCT03103919|147370441|SUPERIORITY||Mean Difference (Final Values)|-0.01|||=|0.947|TWO_SIDED|95.0|-0.33|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.31|-0.33|=0.947
74086698|NCT01998243|147727129|SUPERIORITY|||||||0.937|||||||Wilcoxon (Mann-Whitney)|||||||0.937
74086699|NCT01998243|147727130|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
74086700|NCT01998243|147727131|SUPERIORITY|||||||0.673|||||||Fisher Exact|||||||0.673
74086701|NCT04569786|147727146|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|0.92||||0.649|TWO_SIDED|90.0|0.63|1.34||1-sided|Longitudinal data analysis (LDA) method|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.34|0.63|0.649
74086702|NCT04569786|147727146|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|1.0||||0.495||90.0|0.68|1.48||1-sided|LDA model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.48|0.68|0.495
74086703|NCT04569786|147727146|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|1.1||||0.339|TWO_SIDED|90.0|0.75|1.6||1-sided|LDA Model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.60|0.75|0.339
74028125|NCT01380093|147610087|SUPERIORITY_OR_OTHER||LS Mean Difference|145.8|||<|0.0001|TWO_SIDED|95.0|104.1|187.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||187.5|104.1|<0.0001
74028126|NCT01380093|147610088|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.8|-8.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-8.6|-18.8|<0.0001
74028127|NCT01380093|147610088|SUPERIORITY_OR_OTHER||LS Mean Difference|6.0||||0.0215|TWO_SIDED|95.0|0.9|11.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.1|0.9|0.0215
74086704|NCT04569786|147727146|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|2.26|||<|0.001|TWO_SIDED|90.0|1.56|3.28||1-sided|LDA Model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||3.28|1.56|<0.001
74086705|NCT01684878|147727161|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.88||||0.4983|TWO_SIDED|95.0|0.62|1.27|||2 sided log-rank|||The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan vs paclitaxel), previous anti-angiogenic therapy (yes versus no), and progression-free interval (PFI) since platinum therapy (\< 3 months versus 3-6 months). A hazard ratio \< 1 favored the pertuzumab + chemotherapy treatment arm.||1.27|0.62|0.4983
74086706|NCT01684878|147727163|SUPERIORITY_OR_OTHER||Difference in response rate|6.06||||0.4102|TWO_SIDED|95.0|6.0|18.3|||Fisher Exact||Approximate 95% CI for difference of 2 rates using Hauck-Anderson method.|||18.3|6.0|0.4102
74086707|NCT01684878|147727168|SUPERIORITY_OR_OTHER||Hazard ratio (stratified)|0.9||||0.596|TWO_SIDED|95.0|0.61|1.32|||2 sided log-rank||A hazard ratio \< 1 favored the Pertuzumab + Chemotherapy treatment group|The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan versus paclitaxel), previous angiogenic therapy (yes versus no) and PFI since platinum therapy (\<3 months versus 3-6 months).||1.32|0.61|0.5960
73920988|NCT03103919|147370442|SUPERIORITY||Mean Difference (Final Values)|-0.27|||=|0.306|TWO_SIDED|95.0|-0.79|0.26|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.26|-0.79|=0.306
73920989|NCT03103919|147370443|SUPERIORITY||Mean Difference (Final Values)|0.03|||=|0.819|TWO_SIDED|95.0|-0.25|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.31|-0.25|=0.819
73920990|NCT03103919|147370444|SUPERIORITY||Mean Difference (Final Values)|0.07|||=|0.663|TWO_SIDED|95.0|-0.26|0.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.||||0.41|-0.26|=0.663
73920991|NCT03103919|147370445|SUPERIORITY||Mean Difference (Final Values)|-0.2|||=|0.197|TWO_SIDED|95.0|-0.51|0.11|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.||||0.11|-0.51|=0.197
73920992|NCT03103919|147370448|SUPERIORITY||Odds Ratio (OR)|1.14|||=|0.876|TWO_SIDED|95.0|0.23|5.66||P-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment and center.|Regression, Logistic||Odds ratio was calculated as Control Group/Experimental Group (Rotigotine + Standard Care SS / Rotigotine + Standard Care + Kinesia-360™ wearable device SS) calculated using logistic regression with factors for treatment and center.|||5.66|0.23|=0.876
73920993|NCT01291173|147370450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.014||||0.8825|TWO_SIDED|95.0|-0.203|0.175|||Mixed Models Analysis|||||0.175|-0.203|0.8825
74028128|NCT01380093|147610088|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7|||<|0.0001|TWO_SIDED|95.0|14.6|24.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||24.8|14.6|<0.0001
74086708|NCT00810888|147727169|SUPERIORITY|||||||1||||||not adjusted for multiple comparisons as a prior hypothesis critical value \<0.05|Fisher Exact|||Fisher's exact test||||1.00
74086709|NCT00810888|147727170|SUPERIORITY|||||||0.66|||||||Fisher Exact|||Only the randomized subjects will be compared||||0.66
74086710|NCT00810888|147727171|SUPERIORITY||Sensitivity|38.5||||0.004|TWO_SIDED|95.0|17.6|64.6|||Fisher Exact|||||64.6|17.6|0.004
73920994|NCT01291173|147370450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.258||||0.0077|TWO_SIDED|95.0|-0.446|-0.069|||Mixed Models Analysis|||||-0.069|-0.446|0.0077
73920995|NCT01291173|147370450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.345||||0.0004|TWO_SIDED|95.0|-0.534|-0.155|||Mixed Models Analysis|||||-0.155|-0.534|0.0004
73920996|NCT01291173|147370451|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4676|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.4676
73920997|NCT01291173|147370451|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0198|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0198
73920998|NCT01291173|147370451|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0031
73920999|NCT01291173|147370452|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3341|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.3341
73921000|NCT01291173|147370452|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0063
74028129|NCT01380093|147610089|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3||||0.0007|TWO_SIDED|95.0|-3.6|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.0|-3.6|0.0007
74028130|NCT01380093|147610089|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.0455|TWO_SIDED|95.0|0.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.6|0.0|0.0455
73921001|NCT01291173|147370452|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0022
73921002|NCT01291173|147370453|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0937|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0937
73921003|NCT01291173|147370453|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0127
73921004|NCT01291173|147370453|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0009
73921005|NCT01291173|147370456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0091|TWO_SIDED|95.0|||||Chi-squared|||||||0.0091
73921006|NCT01291173|147370456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED|95.0|||||Chi-squared|||||||0.0004
73921007|NCT01291173|147370456|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Chi-squared|||||||<0.0001
73921008|NCT01291173|147370457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.97||||0.0142|TWO_SIDED|95.0|-5.34|-0.6|||Mixed Models Analysis|||||-0.60|-5.34|0.0142
73921009|NCT01291173|147370457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.25||||0.0075|TWO_SIDED|95.0|-5.62|-0.88|||Mixed Models Analysis|||||-0.88|-5.62|0.0075
73921010|NCT01291173|147370457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.93|||<|0.0001|TWO_SIDED|95.0|-7.3|-2.56|||Mixed Models Analysis|||||-2.56|-7.30|<0.0001
74028131|NCT01380093|147610089|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6|||<|0.0001|TWO_SIDED|95.0|2.3|4.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.9|2.3|<0.0001
73921011|NCT01291173|147370458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15||||0.7538|TWO_SIDED|95.0|-1.11|0.8|||Mixed Models Analysis|||||0.80|-1.11|0.7538
73921012|NCT01291173|147370458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49||||0.3062|TWO_SIDED|95.0|-0.45|1.44|||Mixed Models Analysis|||||1.44|-0.45|0.3062
73921013|NCT01291173|147370458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14||||0.7697|TWO_SIDED|95.0|-0.81|1.09|||Mixed Models Analysis|||||1.09|-0.81|0.7697
73921014|NCT01291173|147370459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53||||0.2046|TWO_SIDED|95.0|-0.29|1.35|||Mixed Models Analysis|||||1.35|-0.29|0.2046
73921015|NCT01291173|147370459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3348|TWO_SIDED|95.0|-0.42|1.22|||Mixed Models Analysis|||||1.22|-0.42|0.3348
73921016|NCT01291173|147370459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81||||0.0505|TWO_SIDED|95.0|0.0|1.63|||Mixed Models Analysis|||||1.63|-0.00|0.0505
73921017|NCT01291173|147370460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0371|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.0371
73921018|NCT01291173|147370460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.1380
73921019|NCT01291173|147370460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0459|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.0459
73921020|NCT01291173|147370460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0278|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||0.0278
73921021|NCT01291173|147370460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||0.0022
73921022|NCT01291173|147370460|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||<0.0001
74028132|NCT01380093|147610090|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.3749|TWO_SIDED|95.0|-0.9|0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.3|-0.9|0.3749
74086711|NCT00810888|147727172|SUPERIORITY||Specificity|94.2||||0.004|TWO_SIDED|95.0|85.6|98.1|||Fisher Exact|||||98.1|85.6|0.004
73921023|NCT01291173|147370460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0149|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||0.0149
73921024|NCT01291173|147370460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||0.0009
73921025|NCT01291173|147370460|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||<0.0001
73921026|NCT01291173|147370461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9||||0.03|TWO_SIDED|95.0|-7.44|-0.38|||Mixed Models Analysis|||||-0.38|-7.44|0.030
73921027|NCT01291173|147370461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4||||0.002|TWO_SIDED|95.0|-8.95|-1.94|||Mixed Models Analysis|||||-1.94|-8.95|0.002
73921028|NCT01291173|147370461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|||<|0.001|TWO_SIDED|95.0|-11.99|-4.92|||Mixed Models Analysis|||||-4.92|-11.99|<0.001
73921029|NCT01291173|147370462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.65||||0.0824|TWO_SIDED|95.0|-5.64|0.34|||Mixed Models Analysis|||||0.34|-5.64|0.0824
73921030|NCT01291173|147370462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.07||||0.1725|TWO_SIDED|95.0|-5.05|0.91|||Mixed Models Analysis|||||0.91|-5.05|0.1725
73921031|NCT01291173|147370462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.71||||0.0148|TWO_SIDED|95.0|-6.69|-0.73|||Mixed Models Analysis|||||-0.73|-6.69|0.0148
73921032|NCT01291173|147370463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.25||||0.2504|TWO_SIDED|95.0|-0.89|3.38|||Mixed Models Analysis|||Aggregate Physical Score||3.38|-0.89|0.2504
73921033|NCT01291173|147370463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.09||||0.309|TWO_SIDED|95.0|-1.02|3.21|||Mixed Models Analysis|||Aggregate Physical Score||3.21|-1.02|0.3090
73921034|NCT01291173|147370463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.0216|TWO_SIDED|95.0|0.37|4.64|||Mixed Models Analysis|||Aggregate Physical Score||4.64|0.37|0.0216
73921035|NCT01291173|147370463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.9587|TWO_SIDED|95.0|-2.75|2.9|||Mixed Models Analysis|||Aggregate Mental Score||2.90|-2.75|0.9587
73921036|NCT01291173|147370463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64||||0.653|TWO_SIDED|95.0|-2.17|3.45|||Mixed Models Analysis|||Aggregate Mental Score||3.45|-2.17|0.6530
73921037|NCT01291173|147370463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.9814|TWO_SIDED|95.0|-2.79|2.86|||Mixed Models Analysis|||Aggregate Mental Score||2.86|-2.79|0.9814
73921038|NCT00810407|147370486|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||"The factor tested was diagnosis. The null hypothesis was that there was no association between diagnosis and the number of participants with treatment-related adverse events."||||<0.001
73921039|NCT00810407|147370487|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||"The factor tested was gender. The null hypothesis was that there was no association between gender and the number of participants with treatment-related adverse events."||||<0.001
73921040|NCT00810407|147370488|SUPERIORITY_OR_OTHER|||||||0.587|||||||Fisher Exact|||"The factor tested was age. The null hypothesis was that there was no association between age of participants and the number of participants with treatment-related adverse events."||||0.587
73921041|NCT00810407|147370488|SUPERIORITY_OR_OTHER|||||||0.428|||||||Cochran-Armitage (EXACT)|||"The factor tested was age. The null hypothesis was that there was no ordinal trend in the number of participants with treatment-related adverse events across the age at baseline."||||0.428
73921042|NCT03108027|147370496|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6096|||||TWO_SIDED|90.0|0.538|0.6811|||Mixed Models Analysis|||||0.6811|0.5380|
73921043|NCT03108027|147370496|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6152|||||TWO_SIDED|90.0|0.5437|0.6868|||Mixed Models Analysis|||||0.6868|0.5437|
73921044|NCT03108027|147370496|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-0.0057|||||TWO_SIDED|90.0|-0.076|0.0647|||Mixed Models Analysis|||||0.0647|-0.0760|
73921045|NCT03108027|147370497|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6206|||||TWO_SIDED|90.0|0.5335|0.7077|||Mixed Models Analysis|||||0.7077|0.5335|
73921046|NCT03108027|147370497|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.7347|||||TWO_SIDED|90.0|0.6469|0.8225|||Mixed Models Analysis|||||0.8225|0.6469|
73921047|NCT03108027|147370497|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-0.1141|||||TWO_SIDED|90.0|-0.197|-0.0311|||Mixed Models Analysis|||||-0.0311|-0.1970|
73921048|NCT03108027|147370498|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|72.1|||||TWO_SIDED|90.0|61.3|82.9|||Mixed Models Analysis|||Morning average PEF||82.9|61.3|
74086712|NCT00810888|147727173|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
73921049|NCT03108027|147370498|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|86.9|||||TWO_SIDED|90.0|76.1|97.8|||Mixed Models Analysis|||Morning average PEF||97.8|76.1|
73921050|NCT03108027|147370498|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-14.8|||||TWO_SIDED|90.0|-25.6|-4.1|||Mixed Models Analysis|||Morning average PEF||-4.1|-25.6|
73921051|NCT03108027|147370498|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|73.1|||||TWO_SIDED|90.0|61.9|84.2|||Mixed Models Analysis|||Evening average PEF||84.2|61.9|
73921052|NCT03108027|147370498|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|58.7||||||90.0|47.5|69.9|||Mixed Models Analysis|||Evening average PEF||69.9|47.5|
73921053|NCT03108027|147370498|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|14.4|||||TWO_SIDED|90.0|3.3|25.5|||Mixed Models Analysis|||Evening average PEF||25.5|3.3|
73921054|NCT00268996|147370505|SUPERIORITY_OR_OTHER||Adjusted percentage change|-11.717||||0.348|TWO_SIDED|95.0|-31.995|14.607|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|||14.607|-31.995|0.348
73921055|NCT00268996|147370506|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.082||||0.22|TWO_SIDED|95.0|-0.214|0.049|||ANCOVA||Difference in adjusted means is shown (Darapladib 160 mg EC tablet - Placebo).|||0.049|-0.214|0.220
73921056|NCT00268996|147370507|SUPERIORITY_OR_OTHER||Adjusted percentage change|3.977||||0.751|TWO_SIDED|95.0|-18.331|32.379|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|||32.379|-18.331|0.751
73921057|NCT00268996|147370508|SUPERIORITY_OR_OTHER||Adjusted percentage change|-60.737|||<|0.001|TWO_SIDED|95.0|-63.486|-57.78|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet at Week 26 (LOCF)||-57.780|-63.486|<0.001
73921058|NCT00268996|147370508|SUPERIORITY_OR_OTHER||Adjusted percentage change|-59.326|||<|0.001|TWO_SIDED|95.0|-62.21|-56.222|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet at Week 52 (LOCF)||-56.222|-62.210|<0.001
73921059|NCT00268996|147370509|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.253||||0.945|TWO_SIDED|95.0|-6.998|7.504|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||7.504|-6.998|0.945
73921060|NCT00268996|147370510|SUPERIORITY_OR_OTHER||Difference in adjusted means|-0.062||||0.898|TWO_SIDED|95.0|-1.009|0.886|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||0.886|-1.009|0.898
73921061|NCT00268996|147370511|SUPERIORITY_OR_OTHER||Difference in adjusted means|-5.165||||0.012|TWO_SIDED|95.0|-9.185|-1.145|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||-1.145|-9.185|0.012
73921062|NCT00268996|147370512|SUPERIORITY_OR_OTHER||Difference in adjusted means|-1.967||||0.047|TWO_SIDED|95.0|-3.912|-0.022|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||-0.022|-3.912|0.047
74086713|NCT00810888|147727174|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
73921063|NCT00268996|147370513|SUPERIORITY_OR_OTHER||Adjusted percentage change|6.958||||0.487|TWO_SIDED|95.0|-11.568|29.364|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Week 26 (LOCF): Comparison between Placebo vs Darapladib 160 mg EC tablet||29.364|-11.568|0.487
74086714|NCT00810888|147727175|OTHER|A Kappa test of overall agreement was used|Kappa|0.77|||||TWO_SIDED|95.0|0.61|0.93|||||A kappa of \>0.75 is considered excellent agreement|||0.93|0.61|
73921064|NCT00268996|147370513|SUPERIORITY_OR_OTHER||Adjusted percentage change|12.255||||0.247|TWO_SIDED|95.0|-7.725|36.562|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Week 52 (LOCF): Comparison between Placebo Vs Darapladib 160 mg EC tablet||36.562|-7.725|0.247
73921065|NCT00268996|147370514|SUPERIORITY_OR_OTHER||Adjusted percentage change|-1.112||||0.687|TWO_SIDED|95.0|-6.363|4.433|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||4.433|-6.363|0.687
73921066|NCT00268996|147370514|SUPERIORITY_OR_OTHER||Adjusted percentage change|-3.237||||0.29|TWO_SIDED|95.0|-8.976|2.865|||ANOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|||2.865|-8.976|0.290
74086715|NCT00810888|147727176|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||Groups 1 and 2 only the spot positive subjects randomized to interventional drug or placebo||||0.25
74086716|NCT02248662|147727288|OTHER|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0||||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Regression, Logistic|Adjusted percentages for receipt of mastectomy were calculated by setting covariates to their observed mean values.|This group is the reference group.|Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.||||<0.05
73921067|NCT00268996|147370515|SUPERIORITY_OR_OTHER||Adjusted percentage change|16.725||||0.022|TWO_SIDED|95.0|2.232|33.271|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||33.271|2.232|0.022
73921068|NCT00268996|147370515|SUPERIORITY_OR_OTHER||Adjusted percentage change|9.256||||0.252|TWO_SIDED|95.0|-6.136|27.172|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||27.172|-6.136|0.252
74086717|NCT02248662|147727288|OTHER|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.05|||<|0.05|TWO_SIDED|95.0|0.71|1.56||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Chi-squared|||Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.||1.56|0.71|<0.05
73921069|NCT00268996|147370516|SUPERIORITY_OR_OTHER||Adjusted percentage change|15.449||||0.196|TWO_SIDED|95.0|-7.204|43.632|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26||43.632|-7.204|0.196
73921070|NCT00268996|147370516|SUPERIORITY_OR_OTHER||Adjusted percentage change|38.567||||0.024|TWO_SIDED|95.0|4.355|83.997|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52||83.997|4.355|0.024
73921071|NCT00268996|147370517|SUPERIORITY_OR_OTHER||Adjusted percentage change|-2.098||||0.79|TWO_SIDED|95.0|-16.303|14.517|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||14.517|-16.303|0.790
73921072|NCT00268996|147370517|SUPERIORITY_OR_OTHER||Adjusted percentage change|1.986||||0.818|TWO_SIDED|95.0|-13.807|20.673|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||20.673|-13.807|0.818
73921073|NCT00268996|147370518|SUPERIORITY_OR_OTHER||Adjusted percentage change|-0.252||||0.98|TWO_SIDED|95.0|-18.151|21.561|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||21.561|-18.151|0.980
73921074|NCT00268996|147370518|SUPERIORITY_OR_OTHER||Adjusted percentage change|-8.585||||0.663|TWO_SIDED|95.0|-39.007|37.012|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||37.012|-39.007|0.663
73921075|NCT00268996|147370520|SUPERIORITY_OR_OTHER||Adjusted treatment Difference|1.758||||0.811|TWO_SIDED|95.0|-12.675|16.192|||ANCOVA||Difference in adjusted means are shown (Darapladib 160mg EC tablet once daily - Placebo).|For vessel volume||16.192|-12.675|0.811
73921076|NCT00268996|147370520|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.627||||0.708|TWO_SIDED|95.0|-11.171|16.425|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet once daily - Placebo).|For lumen volume||16.425|-11.171|0.708
73921077|NCT00268996|147370521|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.012||||0.873|TWO_SIDED|95.0|-0.16|0.136||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area||0.136|-0.160|0.873
73921078|NCT00268996|147370521|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.048||||0.756|TWO_SIDED|95.0|-0.258|0.354|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area||0.354|-0.258|0.756
73921079|NCT00268996|147370521|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.061||||0.687|TWO_SIDED|95.0|-0.237|0.36|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean lumen area||0.360|-0.237|0.687
74086718|NCT02248662|147727288|OTHER||Odds Ratio (OR)|1.9|||<|0.05|TWO_SIDED|95.0|1.27|2.84|||Chi-squared|||||2.84|1.27|<0.05
73921080|NCT00268996|147370522|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.584||||0.854|TWO_SIDED|95.0|-6.819|5.65|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue volume||5.650|-6.819|0.854
74028133|NCT01380093|147610090|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.7939|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.7|-0.5|0.7939
73921081|NCT00268996|147370522|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|1.926||||0.418|TWO_SIDED|95.0|-2.748|6.6||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty volume||6.600|-2.748|0.418
73921082|NCT00268996|147370523|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.0||||0.021|TWO_SIDED|95.0|0.299|3.701|||ANOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue as % of VH plaque||3.701|0.299|0.021
73921083|NCT00268996|147370523|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.739||||0.54|TWO_SIDED|95.0|-1.635|3.114|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty as percentage of VH plaque||3.114|-1.635|0.540
73921084|NCT01528254|147370561|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001|TWO_SIDED|95.0|0.45|0.58|||Regression, Cox|||||0.58|0.45|<0.001
73921085|NCT01528254|147370562|OTHER||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.042|TWO_SIDED|95.0|-0.05|0.0|||Mixed Models Analysis|||||0.00|-0.05|0.042
73921086|NCT01528254|147370563|OTHER||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.19||0.635|TWO_SIDED|95.0|-0.29|0.47|||Mixed Models Analysis|||||0.47|-0.29|0.635
73921087|NCT01528254|147370564|OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.53|TWO_SIDED|95.0|-0.05|0.02|||Mixed Models Analysis|||||0.02|-0.05|0.530
73921088|NCT01528254|147370565|OTHER||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.32||0.381|TWO_SIDED|95.0|-0.35|0.9|||Mixed Models Analysis|||||0.90|-0.35|0.381
74086719|NCT03234608|147727293|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.32||0.56|TWO_SIDED|95.0|-0.44|0.81||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||0.81|-0.44|0.56
73921089|NCT01528254|147370566|OTHER||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.23||0.744|TWO_SIDED|95.0|-0.53|0.38|||Mixed Models Analysis|||From Week 13 to end of Period 1||0.38|-0.53|0.744
73921090|NCT01528254|147370566|OTHER||Slope|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.017|TWO_SIDED|95.0|-0.91|-0.09|||Mixed Models Analysis|||From Week 13 to end of Period 2||-0.09|-0.91|0.017
73921091|NCT01528254|147370566|OTHER||Slope|-0.58|STANDARD_ERROR_OF_MEAN|0.21||0.006|TWO_SIDED|95.0|-0.99|-0.17|||Mixed Models Analysis|||From Week 13 to end of study||-0.17|-0.99|0.006
73921092|NCT01528254|147370567|OTHER||Slope|-5.03|STANDARD_ERROR_OF_MEAN|2.16||0.02|TWO_SIDED|95.0|-9.26|-0.79|||Mixed Models Analysis|||From Week 13 to end of Period 1||-0.79|-9.26|0.020
73921093|NCT01528254|147370567|OTHER||Slope|-5.08|STANDARD_ERROR_OF_MEAN|1.73||0.003|TWO_SIDED|95.0|-8.46|-1.69|||Mixed Models Analysis|||From Week 13 to end of Period 2||-1.69|-8.46|0.003
73921094|NCT01528254|147370567|OTHER||Slope|-5.38|STANDARD_ERROR_OF_MEAN|1.64||0.001|TWO_SIDED|95.0|-8.61|-2.16|||Mixed Models Analysis|||From Week 13 to end of study||-2.16|-8.61|0.001
73921095|NCT00923598|147370574|EQUIVALENCE|A method by Armitage et al was used, where by equivalence of treatments would be concluded if the 95% CI for the difference fell within the prespecified tolerated interval. Under these assumptions, a trial with 36 subjects (72 limbs) would correctly conclude there is no treatment difference with probability 80%, and incorrectly conclude equivalence when there is a difference of 20% with probability 5%.|Mean Difference (Final Values)|3.0||||0.05|TWO_SIDED|95.0|-10.0|17.0|||Fisher Exact|||||17|-10|0.05
73921096|NCT02669433|147370588|SUPERIORITY||Mean Difference (Final Values)|-2.01||||0.158|TWO_SIDED|95.0|-4.8|0.79||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.79|-4.80|0.158
73921097|NCT02669433|147370588|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.6069|TWO_SIDED|95.0|-2.08|3.55||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||3.55|-2.08|0.6069
73921098|NCT02669433|147370589|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.6531|TWO_SIDED|95.0|-2.55|1.6|||Mixed Models Analysis||Placebo - active|||1.60|-2.55|0.6531
73921099|NCT02669433|147370589|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.5274|TWO_SIDED|95.0|-1.41|2.75||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||2.75|-1.41|0.5274
74086720|NCT03234608|147727294|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.79||0.73|TWO_SIDED|95.0|-1.28|1.84||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||1.84|-1.28|0.73
73921100|NCT02669433|147370590|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.3953|TWO_SIDED|95.0|-0.2|0.5||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.5|-0.2|0.3953
73921101|NCT02669433|147370590|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.7008|TWO_SIDED|95.0|-0.28|0.42||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.42|-0.28|0.7008
73921102|NCT00576927|147370592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.655|TWO_SIDED|95.0|0.156|8.717||p-value suspect because of sparse cell counts|Chi-squared|||||8.717|0.156|0.655
74028134|NCT01380093|147610090|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.2524|TWO_SIDED|95.0|-0.3|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.0|-0.3|0.2524
74028135|NCT01380093|147610091|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7||||0.1211|TWO_SIDED|95.0|-3.8|0.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.5|-3.8|0.1211
73921103|NCT02157298|147370640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1053|<|0.0001|TWO_SIDED|95.0|-0.81|-0.39||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-0.39|-0.81|<0.0001
73921104|NCT02157298|147370641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|5.301|<|0.0001|TWO_SIDED|95.0|-33.2|-12.2||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-12.2|-33.2|<0.0001
73921105|NCT02157298|147370642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.255|<|0.0001|TWO_SIDED|95.0|-1.7|-0.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-0.7|-1.7|<0.0001
73921106|NCT02157298|147370643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.4017||0.0743|TWO_SIDED|95.0|-1.51|0.07||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||0.07|-1.51|0.0743
73921107|NCT02157298|147370644|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.4|STANDARD_ERROR_OF_MEAN|3.769||0.3727|TWO_SIDED|95.0|-4.0|10.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Tsitatis, Davidian, Zhang \& Lu, with adjustment with adjustment for baseline value and DPP-4||H0: proportion(dapa) minus proportion(placebo) = 0 versus alternative HA: proportion(dapa) minus proportion(placebo) =/= 0||10.7|-4.0|0.3727
73921108|NCT03171415|147370648|SUPERIORITY||||||>|0.05|TWO_SIDED|5.0|||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||>0.05
73967440|NCT04556656|147472175|SUPERIORITY||Mean Difference (Final Values)|2.89|STANDARD_ERROR_OF_MEAN|1.518||0.0576|TWO_SIDED|95.0|-0.09|5.88|||Mixed Models Analysis|||From baseline to Week 39.||5.88|-0.09|0.0576
73967441|NCT04556656|147472175|SUPERIORITY||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|1.493||0.0418|TWO_SIDED|95.0|0.11|5.99|||Mixed Models Analysis|||From baseline to Week 52.||5.99|0.11|0.0418
73967442|NCT04556656|147472175|SUPERIORITY||Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|1.719||0.1775|TWO_SIDED|95.0|-1.06|5.71|||Mixed Models Analysis|||From baseline to Week 65.||5.71|-1.06|0.1775
73967443|NCT04556656|147472175|SUPERIORITY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.772||0.2627|TWO_SIDED|95.0|-1.5|5.48|||Mixed Models Analysis|||From baseline to Week 78.||5.48|-1.50|0.2627
73967444|NCT04556656|147472176|SUPERIORITY||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|0.712||0.1586|TWO_SIDED|95.0|-0.4|2.41|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.41|-0.4|0.1586
73921109|NCT03171415|147370648|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups, at day 28 and Day 56||||<0.05
73921110|NCT03171415|147370648|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||<0.05
73921111|NCT03171415|147370648|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||<0.05
73921112|NCT03171415|147370649|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73921113|NCT03171415|147370649|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73921114|NCT03171415|147370649|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73921115|NCT03171415|147370649|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73921116|NCT03171415|147370655|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73967445|NCT04556656|147472176|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.701||0.2144|TWO_SIDED|95.0|-0.51|2.25|||Mixed Models Analysis|||From baseline to Week 39. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.25|-0.51|0.2144
73967446|NCT04556656|147472176|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.793||0.9119|TWO_SIDED|95.0|-1.65|1.48|||Mixed Models Analysis|||From baseline to Week 52. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.48|-1.65|0.9119
74028136|NCT01380093|147610091|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.1997|TWO_SIDED|95.0|-0.7|3.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.5|-0.7|0.1997
74028137|NCT01380093|147610091|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1||||0.0057|TWO_SIDED|95.0|0.9|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.2|0.9|0.0057
73921117|NCT04059094|147370657|OTHER||Adjusted means difference|1.5|STANDARD_ERROR_OF_MEAN|2.45||0.5468|TWO_SIDED|95.0|-3.5|6.5|||Mixed model with repeated measurements||Adjusted means difference was calculated as value from BI 1265162 200μg minus value from placebo group.|Mixed Model for Repeated Measures (MMRM) with fixed effects for baseline, visit, treatment, treatment-by-visit interaction, baseline-by-visit interaction, and random effect for patient was applied. No hypothesis testing was performed, as this trial was prematurely discontinued. MMRM only included data from 200µg BI and placebo, as the sample size of the BI 20µg, BI 50µg and BI 100µg dose levels was limited because of the premature discontinuation of the trial.||6.5|-3.5|0.5468
73921118|NCT04059094|147370658|OTHER||Adjuste means difference|2.1|STANDARD_ERROR_OF_MEAN|1.83||0.3039|TWO_SIDED|95.0|-2.4|6.5|||ANCOVA||Adjusted means difference was calculated as value from BI 1265162 200μg minus value from placebo group.|ANCOVA based on analysis of covariance with fixed effects for baseline and treatment was applied. Statistical analysis was performed for 200μg BI and placebo groups only. No hypothesis testing was performed, as this trial was prematurely discontinued. ANCOVA only included data from 200µg BI and placebo, as the sample size of the BI 20µg, BI 50µg and BI 100µg dose levels was limited because of the premature discontinuation of the trial.||6.5|-2.4|0.3039
73921119|NCT00883116|147370674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.0397|TWO_SIDED|95.0|1.0|1.7|||Log Rank|||||1.7|1.0|0.0397
73921120|NCT00883116|147370675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.8011|TWO_SIDED|95.0|0.8|1.3|||Log Rank|||||1.3|0.8|0.8011
73921121|NCT03715764|147370678|SUPERIORITY|||||||0.87||||||Results for the final model, variable GROUP, adjusted for confounders.|Mixed Models Analysis|||||||0.87
73921122|NCT03715764|147370678|SUPERIORITY||||||<|0.001||||||Results for the final model for the variable TIME, adjusted for confounders.|Mixed Models Analysis|||||||<0.001
73921123|NCT03715764|147370678|SUPERIORITY|||||||0.18||||||Results for the final model, variable Group x Time (Statistical interaction of group and time), adjusted for confounders.|Mixed Models Analysis|||||||0.18
73921124|NCT03715764|147370679|SUPERIORITY|||||||0.56||||||Results for the final model, variable GROUP, adjusted for confounders.|Mixed Models Analysis|||||||0.56
73921125|NCT03715764|147370679|SUPERIORITY|||||||0.0049||||||Results for the final model, variable TIME, adjusted for confounders.|Mixed Models Analysis|||||||0.0049
73967447|NCT04556656|147472176|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.844||0.7339|TWO_SIDED|95.0|-1.38|1.95|||Mixed Models Analysis|||From baseline to Week 65. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.95|-1.38|0.7339
73967448|NCT04556656|147472176|SUPERIORITY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.859||0.6213|TWO_SIDED|95.0|-1.27|2.12|||Mixed Models Analysis|||From baseline to Week 78. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.12|-1.27|0.6213
73967449|NCT04556656|147472177|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.777||0.8205|TWO_SIDED|95.0|-1.71|1.36|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.36|-1.71|0.8205
74086721|NCT03234608|147727295|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.17||0.94|TWO_SIDED|95.0|-0.35|0.33||The threshold for statistical significance was p\<0.05.|Regression, Linear|||Statistical analysis for Individual Level Healthcare Self-Efficacy Sub-scale.||0.33|-0.35|0.94
73921126|NCT03715764|147370679|SUPERIORITY|||||||0.49||||||Results for the final model, adjusted for confounders, for the variable Group x Time (Statistical interaction of group and time).|Mixed Models Analysis|||||||0.49
73921127|NCT03715764|147370680|SUPERIORITY|Used as a confounder in the mixed effect model analysis for primary outcome. All participants enrolled in the study were included in the 12 months analysis.|||||<|0.2||||||Confounding variables with p-values \< 0.2 were carried forward to the final model.|Mixed Models Analysis|||||||<0.2
73921128|NCT03715764|147370681|SUPERIORITY|Used as a confounder in the mixed effect model analysis for primary outcome. All participants enrolled in the study were included in the 12 months analysis.|||||<|0.2||||||Confounding variables with p-values \< 0.2 were carried forward to the final model.|Mixed Models Analysis|||||||<0.2
73921129|NCT00818662|147370686|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.8||||0.476||95.0|-3.1|1.5|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||1.5|-3.1|0.476
74086722|NCT03234608|147727295|SUPERIORITY||Slope|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.65|TWO_SIDED|95.0|-0.33|0.52|||Regression, Linear|||Statistical analysis for Relationship-Dependent Healthcare Self-Efficacy Sub-scale||0.52|-0.33|0.65
73921130|NCT00818662|147370686|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.53||95.0|-1.6|3.0|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||3.0|-1.6|0.530
73921131|NCT00818662|147370687|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.812||95.0|-2.9|3.7|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||3.7|-2.9|0.812
73921132|NCT00818662|147370687|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.9||||0.602||95.0|-4.3|2.5|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||2.5|-4.3|0.602
73921133|NCT00818662|147370688|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.7||||0.368||95.0|-2.3|0.8|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)|||0.8|-2.3|0.368
73921134|NCT00818662|147370688|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.8||||0.319||95.0|-0.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)|||2.4|-0.8|0.319
73921135|NCT00818662|147370689|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.3||||0.778||95.0|-1.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)|||2.4|-1.8|0.778
73921136|NCT00818662|147370689|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.2||||0.851||95.0|-2.3|1.9|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)|||1.9|-2.3|0.851
73921137|NCT00818662|147370690|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.1||||0.306||95.0|-0.1|0.3|||Mixed Models Analysis|||||0.3|-0.1|0.306
73921138|NCT00818662|147370690|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.3||||0.028||95.0|0.0|0.5|||Mixed Models Analysis|||||0.5|0.0|0.028
73921139|NCT00818662|147370691|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.1||||0.66||95.0|-0.3|0.2|||Mixed Models Analysis|||||0.2|-0.3|0.660
73921140|NCT00818662|147370691|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.766||95.0|-0.2|0.3|||Mixed Models Analysis|||||0.3|-0.2|0.766
73921141|NCT00818662|147370692|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.9||||0.206||95.0|-1.0|4.8|||ANCOVA|||||4.8|-1.0|0.206
73921142|NCT00818662|147370692|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.4||||0.331||95.0|-4.3|1.5|||ANCOVA|||||1.5|-4.3|0.331
73921143|NCT00818662|147370693|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.64||95.0|-2.1|3.4|||ANCOVA|||||3.4|-2.1|0.640
73967450|NCT04556656|147472177|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.067||0.4028|TWO_SIDED|95.0|-3.0|1.21|||Mixed Models Analysis|||From baseline to Week 39. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.21|-3.0|0.4028
73967451|NCT04556656|147472177|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.051||0.7577|TWO_SIDED|95.0|-2.4|1.75|||Mixed Models Analysis|||From baseline to Week 52. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.75|-2.4|0.7577
73967452|NCT04556656|147472177|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|1.158||0.7605|TWO_SIDED|95.0|-2.64|1.93|||Mixed Models Analysis|||From baseline to Week 65. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.93|-2.64|0.7605
74086723|NCT03234608|147727296|SUPERIORITY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|0.52||0.66|TWO_SIDED|95.0|-1.25|0.79||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||0.79|-1.25|0.66
73921144|NCT00818662|147370693|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|2.5||||0.075||95.0|-0.3|5.3|||ANCOVA|||||5.3|-0.3|0.075
73921145|NCT00818662|147370694|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.1||||0.093||95.0|-0.2|2.3|||ANCOVA|||||2.3|-0.2|0.093
73921146|NCT00818662|147370694|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.1||||0.094||95.0|-0.2|2.3|||ANCOVA|||||2.3|-0.2|0.094
74086724|NCT03234608|147727297|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.78||0.85|TWO_SIDED|95.0|-1.4|1.69||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||1.69|-1.40|0.85
73921147|NCT00818662|147370695|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.1||||0.096||95.0|-2.3|0.2|||ANCOVA|||||0.2|-2.3|0.096
73921148|NCT00818662|147370695|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.0||||0.123||95.0|-2.2|0.3|||ANCOVA|||||0.3|-2.2|0.123
73921149|NCT00818662|147370696|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.167||95.0|-0.2|1.0|||ANCOVA|||||1.0|-0.2|0.167
73921150|NCT00818662|147370696|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.998||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.998
73921151|NCT00818662|147370697|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.173||95.0|-0.2|0.9|||ANCOVA|||||0.9|-0.2|0.173
73921152|NCT00818662|147370697|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.1||||0.744||95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.744
73921153|NCT00818662|147370698|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.5||||0.238||95.0|-1.0|4.0|||ANCOVA|||||4.0|-1.0|0.238
73921154|NCT00818662|147370698|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.1||||0.4||95.0|-3.6|1.4|||ANCOVA|||||1.4|-3.6|0.400
73921155|NCT00818662|147370699|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.6||||0.695||95.0|-3.6|2.4|||ANCOVA|||||2.4|-3.6|0.695
73921156|NCT00818662|147370699|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.3||||0.41||95.0|-4.5|1.9|||ANCOVA|||||1.9|-4.5|0.410
73921157|NCT00818662|147370700|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.988||95.0|-1.5|1.5|||ANCOVA|||||1.5|-1.5|0.988
73921158|NCT00818662|147370700|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.555||95.0|-1.0|1.9|||ANCOVA|||||1.9|-1.0|0.555
73921159|NCT00818662|147370701|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.5||||0.783||95.0|-12.2|9.2|||ANCOVA|||||9.2|-12.2|0.783
73921160|NCT00818662|147370701|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-2.1||||0.7||95.0|-13.1|8.8|||ANCOVA|||||8.8|-13.1|0.700
73921161|NCT00818662|147370702|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-15.2||||0.191||95.0|-38.0|7.7|||ANCOVA|||||7.7|-38.0|0.191
73921162|NCT00818662|147370702|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.6||||0.892||95.0|-25.4|22.1|||ANCOVA|||||22.1|-25.4|0.892
73921163|NCT00818662|147370703|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.1||||0.588||95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.588
73921164|NCT00818662|147370703|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.2||||0.351||95.0|-0.5|0.2|||ANCOVA|||||0.2|-0.5|0.351
73921165|NCT01686633|147370723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.045|0.171|||ANCOVA|||||0.171|0.045|<0.001
73921166|NCT01686633|147370723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|||||TWO_SIDED|95.0|-0.037|0.086||||||||0.086|-0.037|
73921167|NCT00613938|147370752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.4|STANDARD_ERROR_OF_MEAN|11.9|<|0.001||95.0|39.01|85.73||Comparisons of tapentadol dose groups and placebo was performed with Hochberg procedure for adjustment for the multiple tests.|ANCOVA||The results shown are the treatment group differences between Tapentadol IR 50mg group and placebo.|Null hypothesis: There are no differences in pain intensity measured by SPID-48 hours between any of tapentadol dose groups and placebo. ANCOVA model with factors of treatment, center and baseline pain intensity score was used for the primary analysis.||85.73|39.01|<0.001
73921168|NCT02636868|147370758|SUPERIORITY|||||||0.363||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline fraction of inspired oxygen (FiO₂) in model||Null hypothesis is no difference across treatment groups||||0.363
73921169|NCT02636868|147370758|SUPERIORITY|||||||0.36||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatments||||0.360
73921170|NCT02636868|147370758|SUPERIORITY|||||||0.461||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatments||||0.461
73921171|NCT02636868|147370759|SUPERIORITY|||||||0.401||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.401
73967453|NCT04556656|147472177|SUPERIORITY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|1.323||0.6694|TWO_SIDED|95.0|-2.05|3.18|||Mixed Models Analysis|||From baseline to Week 78. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||3.18|-2.05|0.6694
73921172|NCT02636868|147370759|SUPERIORITY|||||||0.372||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.372
73921173|NCT02636868|147370759|SUPERIORITY|||||||0.648||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.648
73921174|NCT02636868|147370760|SUPERIORITY|||||||0.996||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference across treatments||||0.996
73921175|NCT02636868|147370760|SUPERIORITY|||||||0.951||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference between treatments||||0.951
73921176|NCT02636868|147370760|SUPERIORITY|||||||0.995||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference between treatments||||0.995
73921177|NCT02636868|147370761|SUPERIORITY|||||||0.312||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatment groups||||0.312
74028138|NCT01380093|147610092|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.8||||0.0057|TWO_SIDED|95.0|-16.7|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.0|-16.7|0.0057
74086725|NCT03200535|147727303|SUPERIORITY|Superiority analysis|||||<|0.001|||||||Chi-squared|||||||<0.001
74086726|NCT03200535|147727304|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73921178|NCT02636868|147370761|SUPERIORITY|||||||0.094||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatment groups||||0.094
73921179|NCT02636868|147370761|SUPERIORITY|||||||0.414||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model.||Null hypothesis of no difference between treatment groups||||0.414
73921180|NCT02636868|147370762|SUPERIORITY|||||||0.099||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline fraction of inspired oxygen (FiO2) in model||Null hypothesis of no difference between treatment groups||||0.099
73921181|NCT02636868|147370762|SUPERIORITY|||||||0.09||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO2 in model||Null hypothesis of no difference between treatments||||0.090
73921182|NCT02636868|147370762|SUPERIORITY|||||||0.461||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO2 in model||Null hypothesis of no difference between treatment groups||||0.461
73921183|NCT02636868|147370763|SUPERIORITY|||||||0.534||||||A priori threshold for statistical significance set at 0.05|ANOVA|treatment and pooled site in model||Null hypothesis of no treatment between treatments||||0.534
73921184|NCT02636868|147370763|SUPERIORITY|||||||0.48||||||A priori threshold for statistical significance set at 0.05|ANOVA|Treatment and pooled site in model||Null hypothesis of no difference between treatment groups||||0.480
73861471|NCT04411420|147268792|SUPERIORITY||Median Difference (Final Values)|-0.01||||0.508|TWO_SIDED|95.0|-0.04|0.02||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.02|-0.04|0.508
73921185|NCT02636868|147370763|SUPERIORITY|||||||0.313||||||A priori threshold for statistical significance set at 0.05|ANOVA|Treatment and pooled site in model||Null hypothesis of no difference between treatment groups||||0.313
73921186|NCT02801942|147370827|OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|3.307|||TWO_SIDED|95.0|-4.59|9.21|||||The mean difference in circulating B lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||9.21|-4.59|
73921187|NCT02801942|147370827|OTHER||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|2.398|||TWO_SIDED|95.0|-1.46|8.54|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||8.54|-1.46|
73921188|NCT02801942|147370827|OTHER||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|1.854|||TWO_SIDED|95.0|-6.87|0.86|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||0.86|-6.87|
73921189|NCT02801942|147370827|OTHER||Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|4.482||||95.0|-11.86|6.84|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||6.84|-11.86|
73921190|NCT02801942|147370828|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|2.658|||TWO_SIDED|95.0|-2.22|8.98|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.98|-2.22|
73921191|NCT02801942|147370828|OTHER||Mean Difference (Final Values)|8.59|STANDARD_ERROR_OF_MEAN|5.833|||TWO_SIDED|95.0|-3.72|20.91|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||20.91|-3.72|
73967454|NCT03498651|147472178|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|1.04|1.16|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||1.16|1.04|
73967455|NCT03498651|147472178|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.43|0.2|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.20|-0.43|
74028139|NCT01380093|147610092|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5||||0.1918|TWO_SIDED|95.0|-2.3|11.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.4|-2.3|0.1918
74028140|NCT01380093|147610092|SUPERIORITY_OR_OTHER||LS Mean Difference|14.4|||<|0.0001|TWO_SIDED|95.0|7.5|21.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||21.2|7.5|<0.0001
73921192|NCT02801942|147370828|OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|2.347|||TWO_SIDED|95.0|-6.53|3.38|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.38|-6.53|
73921193|NCT02801942|147370828|OTHER||Mean Difference (Final Values)|-8.31|STANDARD_ERROR_OF_MEAN|5.221|||TWO_SIDED|95.0|-19.32|2.71|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.71|-19.32|
73921194|NCT02801942|147370829|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-0.9|2.75|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.75|-0.90|
73921195|NCT02801942|147370829|OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.07|0.19|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.19|-0.07|
73921196|NCT02801942|147370829|OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-3.41|2.84|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.|||2.84|-3.41|
73921197|NCT02801942|147370829|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.1|0.13|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.|||0.13|-0.10|
73921198|NCT02801942|147370829|OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|95.0|-0.19|0.31|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.31|-0.19|
73921199|NCT02801942|147370829|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|1.482|||TWO_SIDED|95.0|-3.23|2.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.96|-3.23|
73921200|NCT02801942|147370830|OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|2.231|||TWO_SIDED|95.0|-3.14|6.23|||||The mean difference in B-cells in (Healthy participants versus NOT1D participants) iLN has been presented.|||6.23|-3.14|
73921201|NCT02801942|147370830|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.25|0.34|||||The mean difference in CD56bright sNK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.25|
73921202|NCT02801942|147370830|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.253|||TWO_SIDED|95.0|-0.54|0.52|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.52|-0.54|
73921203|NCT02801942|147370830|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.15|0.1|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.10|-0.15|
73921204|NCT02801942|147370830|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|-0.21|0.34|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.21|
73921205|NCT02801942|147370830|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.487|||TWO_SIDED|95.0|-1.1|0.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.96|-1.10|
73921206|NCT02801942|147370831|OTHER||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.326|||TWO_SIDED|95.0|-1.73|3.8|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.80|-1.73|
73921207|NCT02801942|147370831|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|2.324|||TWO_SIDED|95.0|-7.54|2.16|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.|||2.16|-7.54|
73921208|NCT02801942|147370831|OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.738|||TWO_SIDED|95.0|-1.12|1.95|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.|||1.95|-1.12|
73921209|NCT02801942|147370832|OTHER||Mean Difference (Final Values)|6.84|STANDARD_ERROR_OF_MEAN|5.564|||TWO_SIDED|95.0|-4.92|18.6|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||18.60|-4.92|
73921210|NCT02801942|147370832|OTHER||Mean Difference (Final Values)|-7.89|STANDARD_ERROR_OF_MEAN|7.918|||TWO_SIDED|95.0|-24.77|9.0|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.|||9.00|-24.77|
73921211|NCT02801942|147370832|OTHER||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|2.379|||TWO_SIDED|95.0|-6.66|3.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.73|-6.66|
73921212|NCT02801942|147370833|OTHER||Mean Difference (Final Values)|1.33|STANDARD_ERROR_OF_MEAN|4.558|||TWO_SIDED|95.0|-8.17|10.84|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||10.84|-8.17|
73967456|NCT03498651|147472179|SUPERIORITY||Mean Difference (Net)|-0.63|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.69|-0.57|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.57|-0.69|
74028141|NCT01380093|147610093|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.5||||0.0013|TWO_SIDED|95.0|-50.2|-12.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-12.9|-50.2|0.0013
74028142|NCT01380093|147610093|SUPERIORITY_OR_OTHER||LS Mean Difference|14.9||||0.1136|TWO_SIDED|95.0|-3.7|33.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.5|-3.7|0.1136
73921213|NCT02801942|147370833|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|4.658|||TWO_SIDED|95.0|-11.57|7.86|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.86|-11.57|
73921214|NCT02801942|147370834|OTHER||Mean Difference (Final Values)|12.23|STANDARD_ERROR_OF_MEAN|5.658|||TWO_SIDED|95.0|0.38|24.09|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||24.09|0.38|
73921215|NCT02801942|147370834|OTHER||Mean Difference (Final Values)|-10.87|STANDARD_ERROR_OF_MEAN|6.961|||TWO_SIDED|95.0|-25.52|3.78|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.78|-25.52|
74028143|NCT01380093|147610093|SUPERIORITY_OR_OTHER||LS Mean Difference|46.5|||<|0.0001|TWO_SIDED|95.0|27.8|65.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||65.1|27.8|<0.0001
73921216|NCT02801942|147370837|OTHER||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|6.329|||TWO_SIDED|95.0|-11.41|14.99|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||14.99|-11.41|
73921217|NCT02801942|147370837|OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-4.6|4.91|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||4.91|-4.60|
73921218|NCT02801942|147370837|OTHER||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|3.297|||TWO_SIDED|95.0|-2.5|11.26|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||11.26|-2.50|
73921219|NCT02801942|147370837|OTHER||Mean Difference (Final Values)|-6.06|STANDARD_ERROR_OF_MEAN|5.729|||TWO_SIDED|95.0|-18.01|5.89|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||5.89|-18.01|
73921220|NCT02801942|147370837|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-0.67|0.6|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||0.60|-0.67|
73921221|NCT02801942|147370838|OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|3.133|||TWO_SIDED|95.0|-5.33|7.73|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.73|-5.33|
73921222|NCT02801942|147370838|OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.466|||TWO_SIDED|95.0|-3.73|2.41|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.41|-3.73|
73921223|NCT02801942|147370838|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|-7.67|3.96|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.96|-7.67|
73921224|NCT02801942|147370838|OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|6.342|||TWO_SIDED|95.0|-12.54|13.87|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||13.87|-12.54|
73921225|NCT02801942|147370838|OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.492|||TWO_SIDED|95.0|-1.71|0.36|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.36|-1.71|
73921226|NCT02801942|147370841|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.236|||TWO_SIDED|95.0|-0.84|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.16|-0.84|
73921227|NCT02801942|147370842|OTHER||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|4.362|||TWO_SIDED|95.0|-15.37|2.96|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.96|-15.37|
73921228|NCT02801942|147370843|OTHER||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.269|||TWO_SIDED|95.0|-1.61|3.68|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.68|-1.61|
73921229|NCT02801942|147370843|OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|3.152|||TWO_SIDED|95.0|-8.12|5.03|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||5.03|-8.12|
73921230|NCT02801942|147370843|OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|2.089|||TWO_SIDED|95.0|-4.59|4.13|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||4.13|-4.59|
73921231|NCT02801942|147370843|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|3.835|||TWO_SIDED|95.0|-7.08|8.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||8.92|-7.08|
74028144|NCT01380093|147610094|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.6||||0.0006|TWO_SIDED|95.0|-83.2|-24.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-24.0|-83.2|0.0006
74086727|NCT01181531|147727309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|5.3||0.346|TWO_SIDED|95.0|-15.4|5.4||Unadjusted. Model contains baseline stratification factor for type of Vitamin D administered at the site|Mixed Models Analysis||Cinacalcet - Vitamin D|Null hypothesis: no difference in % change from baseline in PTH comparing the two treatment arms.||5.4|-15.4|0.346
73921232|NCT02801942|147370843|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|95.0|-0.4|0.21|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.21|-0.40|
73921233|NCT02801942|147370844|OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.236||||95.0|-0.23|0.75|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.75|-0.23|
73921234|NCT02801942|147370844|OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|3.943|||TWO_SIDED|95.0|-10.2|6.29|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.29|-10.20|
73921235|NCT02801942|147370844|OTHER||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.621|||TWO_SIDED|95.0|-5.38|9.69|||||The mean difference in Effector Memory Conv T cells(Healthy participants versus NOT1D participants) in iLN has been presented.|||9.69|-5.38|
73921236|NCT02801942|147370844|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|4.629|||TWO_SIDED|95.0|-10.47|8.86|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.86|-10.47|
73921237|NCT02801942|147370844|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.268|||TWO_SIDED|95.0|-0.77|0.34|||||The mean difference in Stem cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.77|
74028145|NCT01380093|147610094|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2||||0.1207|TWO_SIDED|95.0|-6.3|52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||52.7|-6.3|0.1207
74086728|NCT01181531|147727310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.11|TWO_SIDED|95.0|0.92|2.29||Stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D|||2.29|0.92|0.110
73921238|NCT02801942|147370845|OTHER||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|2.556|||TWO_SIDED|95.0|-10.42|0.25|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.25|-10.42|
73921239|NCT02801942|147370845|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.15|0.07|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.07|-0.15|
73921240|NCT02801942|147370845|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.428|||TWO_SIDED|95.0|-3.08|2.88|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.88|-3.08|
73921241|NCT02801942|147370845|OTHER||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|4.294|||TWO_SIDED|95.0|-6.87|11.05|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||11.05|-6.87|
73921242|NCT02801942|147370845|OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|2.382|||TWO_SIDED|95.0|-4.94|5.0|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||5.00|-4.94|
74086729|NCT01181531|147727311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.346|TWO_SIDED|95.0|0.74|2.39||stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D|||2.39|0.74|0.346
73921243|NCT02801942|147370845|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.112|||TWO_SIDED|95.0|-2.31|2.32|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.32|-2.31|
73921244|NCT02801942|147370845|OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|95.0|-2.73|1.55|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.55|-2.73|
73921245|NCT02801942|147370845|OTHER||Mean Difference (Final Values)|1.57|STANDARD_ERROR_OF_MEAN|1.474|||TWO_SIDED|95.0|-1.51|4.64|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||4.64|-1.51|
73921246|NCT02801942|147370845|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.504|||TWO_SIDED|95.0|-1.05|1.05|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.05|-1.05|
73921247|NCT02801942|147370846|OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|3.607|||TWO_SIDED|95.0|-5.99|9.07|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||9.07|-5.99|
74028146|NCT01380093|147610094|SUPERIORITY_OR_OTHER||LS Mean Difference|76.8|||<|0.0001|TWO_SIDED|95.0|47.3|106.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||106.4|47.3|<0.0001
73921248|NCT02801942|147370846|OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.855|||TWO_SIDED|95.0|-2.43|1.18|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.18|-2.43|
73921249|NCT02801942|147370846|OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.391|||TWO_SIDED|95.0|-2.49|3.31|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.31|-2.49|
73921250|NCT02801942|147370846|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.824|||TWO_SIDED|95.0|-9.39|2.39|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.39|-9.39|
73921251|NCT02801942|147370846|OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.738|||TWO_SIDED|95.0|-1.29|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.78|-1.29|
73921252|NCT02801942|147370846|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.544|||TWO_SIDED|95.0|-0.73|1.54|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.54|-0.73|
73921253|NCT02801942|147370846|OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|1.246|||TWO_SIDED|95.0|-2.12|3.07|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.07|-2.12|
73921254|NCT02801942|147370846|OTHER||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|2.641|||TWO_SIDED|95.0|-2.45|8.55|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.55|-2.45|
73921255|NCT02801942|147370846|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|95.0|-0.92|0.96|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.96|-0.92|
73921256|NCT02801942|147370847|OTHER||Mean Difference (Final Values)|-4.83|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-10.71|1.05|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.05|-10.71|
73921257|NCT02801942|147370847|OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.953|||TWO_SIDED|95.0|-2.82|1.16|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.16|-2.82|
73921258|NCT02801942|147370847|OTHER||Mean Difference (Final Values)|-2.88|STANDARD_ERROR_OF_MEAN|1.536||||95.0|-6.08|0.33|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.33|-6.08|
73921259|NCT02801942|147370847|OTHER||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|0.963|||TWO_SIDED|95.0|-0.2|3.81|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.81|-0.20|
73921260|NCT02801942|147370847|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.289|||TWO_SIDED|95.0|-2.99|2.39|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.39|-2.99|
73921261|NCT02801942|147370847|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|1.907|||TWO_SIDED|95.0|-0.59|7.36|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.36|-0.59|
74028147|NCT01380093|147610095|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.8||||0.0008|TWO_SIDED|95.0|-118.6|-33.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-33.0|-118.6|0.0008
74028148|NCT01380093|147610095|SUPERIORITY_OR_OTHER||LS Mean Difference|31.8||||0.141|TWO_SIDED|95.0|-10.8|74.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||74.5|-10.8|0.1410
74028149|NCT01380093|147610095|SUPERIORITY_OR_OTHER||LS Mean Difference|107.7|||<|0.0001|TWO_SIDED|95.0|64.9|150.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||150.5|64.9|<0.0001
74028150|NCT01380093|147610096|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.0|||<|0.0001|TWO_SIDED|95.0|-14.4|-5.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-5.6|-14.4|<0.0001
74028151|NCT01380093|147610096|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.0529|TWO_SIDED|95.0|-0.1|8.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.7|-0.1|0.0529
73861472|NCT04411420|147268792|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.03|0.03||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.03|-0.03|0.992
73861473|NCT04411420|147268792|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.389|TWO_SIDED|95.0|-0.05|0.02||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.02|-0.05|0.389
73861474|NCT01062061|147268836|SUPERIORITY_OR_OTHER|||||||0.9733||95.0|||||Chi-squared|||||||0.9733
73921262|NCT02801942|147370847|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|1.413|||TWO_SIDED|95.0|-4.11|1.78|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.78|-4.11|
73921263|NCT02801942|147370848|OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.918|||TWO_SIDED|95.0|-5.6|6.63|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.63|-5.60|
73921264|NCT02801942|147370848|OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.842|||TWO_SIDED|95.0|-7.93|-0.26|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||-0.26|-7.93|
73921265|NCT02801942|147370848|OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|1.209|||TWO_SIDED|95.0|-4.34|1.24|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.24|-4.34|
74028152|NCT01380093|147610096|SUPERIORITY_OR_OTHER||LS Mean Difference|14.3|||<|0.0001|TWO_SIDED|95.0|9.9|18.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.7|9.9|<0.0001
73861475|NCT01062061|147268837|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Chi-squared|||||||0.0001
73921266|NCT02801942|147370848|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.725|||TWO_SIDED|95.0|-4.51|2.77|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.77|-4.51|
73921267|NCT02801942|147370848|OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|2.193|||TWO_SIDED|95.0|-5.02|4.09|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.09|-5.02|
73921268|NCT02801942|147370848|OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|3.405|||TWO_SIDED|95.0|-6.52|7.68|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.68|-6.52|
73921269|NCT02801942|147370848|OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.811|||TWO_SIDED|95.0|-2.21|1.4|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.40|-2.21|
73921270|NCT02801942|147370849|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.601|||TWO_SIDED|95.0|-0.86|1.65|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.65|-0.86|
73921271|NCT02801942|147370850|OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.929|||TWO_SIDED|95.0|-2.18|1.7|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.70|-2.18|
73921272|NCT02801942|147370851|OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|95.0|0.02|1.87|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.87|0.02|
74028153|NCT01380093|147610097|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0806|TWO_SIDED|95.0|-3.8|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-3.8|0.0806
73861476|NCT00098722|147268847|SUPERIORITY_OR_OTHER||LS mean difference|-1.021|STANDARD_ERROR_OF_MEAN|0.1802|||TWO_SIDED|97.5|-1.426|-0.616||||||The difference between the treatment least square means (LS means) adjusted for randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.616|-1.426|
73921273|NCT02801942|147370851|OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.04|0.38|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.38|-2.04|
73921274|NCT02801942|147370852|OTHER||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|4.299|||TWO_SIDED|95.0|-11.81|6.27|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.27|-11.81|
73921275|NCT02801942|147370852|OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|95.0|-0.04|4.44|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.44|-0.04|
73921276|NCT02801942|147370853|OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|2.214|||TWO_SIDED|95.0|-5.91|3.32|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.32|-5.91|
73921277|NCT02801942|147370853|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|0.28|1.57|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|0.28|
73921278|NCT02801942|147370853|OTHER||Mean Difference (Final Values)|4.21|STANDARD_ERROR_OF_MEAN|3.017|||TWO_SIDED|95.0|-2.08|10.51|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||10.51|-2.08|
73921279|NCT02801942|147370853|OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.985|||TWO_SIDED|95.0|-3.03|1.08|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.08|-3.03|
73921280|NCT02801942|147370853|OTHER||Mean Difference (Final Values)|-4.86|STANDARD_ERROR_OF_MEAN|3.802|||TWO_SIDED|95.0|-12.8|3.07|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.07|-12.80|
73921281|NCT02801942|147370853|OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|4.733|||TWO_SIDED|95.0|-1.27|18.47|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||18.47|-1.27|
73921282|NCT02801942|147370854|OTHER||Mean Difference (Final Values)|6.53|STANDARD_ERROR_OF_MEAN|4.905||||95.0|-3.78|16.85|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||16.85|-3.78|
73921283|NCT02801942|147370854|OTHER||Mean Difference (Final Values)|-8.54|STANDARD_ERROR_OF_MEAN|4.595|||TWO_SIDED|95.0|-18.17|1.1|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.10|-18.17|
73967457|NCT03498651|147472179|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_DEVIATION|0.17|||TWO_SIDED|95.0|-0.26|0.39|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.39|-0.26|
73967458|NCT03498651|147472180|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|0.42|0.54|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.||"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|0.54|0.42|
73967459|NCT03498651|147472180|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.23|0.39|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.39|-0.23|
74028154|NCT01380093|147610097|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.2769|TWO_SIDED|95.0|-0.9|3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.1|-0.9|0.2769
74028155|NCT01380093|147610097|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0056|TWO_SIDED|95.0|0.9|5.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.0|0.9|0.0056
74028156|NCT01380093|147610098|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.11|TWO_SIDED|95.0|-1.7|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-1.7|0.1100
74086730|NCT00987831|147727312|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|30.0||||0.2738|TWO_SIDED|95.0|5.0|95.0||Definition of Moderate Disease was \</= 3 BILAG B (moderate) organ scores, no A (severe) scores and SLEDAI \</=10. Severe disease was \> 3 BILAG B or \>/= BILAG A or SLEDAI \> 10 or meets definition for severe flare on the SELENA SLEDAI Flare Index|Log Rank|||||95|5|0.2738
73921284|NCT02801942|147370854|OTHER||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|2.519|||TWO_SIDED|95.0|-3.23|7.45|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.45|-3.23|
73921285|NCT02801942|147370854|OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-0.98|7.59|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.59|-0.98|
73921286|NCT02801942|147370854|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|4.026|||TWO_SIDED|95.0|-8.23|8.67|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||8.67|-8.23|
73921287|NCT02801942|147370854|OTHER||Mean Difference (Final Values)|8.31|STANDARD_ERROR_OF_MEAN|4.595|||TWO_SIDED|95.0|-1.32|17.95|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||17.95|-1.32|
73921288|NCT02801942|147370855|OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.601|||TWO_SIDED|95.0|-0.94|1.57|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|-0.94|
73921289|NCT02801942|147370855|OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|95.0|0.0|1.28|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.28|0.00|
73921290|NCT02801942|147370855|OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|95.0|-0.33|1.11|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.11|-0.33|
73921291|NCT02801942|147370855|OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.78|0.47|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.47|-0.78|
73921292|NCT02801942|147370856|OTHER||Mean Difference (Final Values)|1.78|STANDARD_ERROR_OF_MEAN|0.989|||TWO_SIDED|95.0|-0.3|3.86|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.86|-0.30|
73921293|NCT02801942|147370856|OTHER||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|4.716|||TWO_SIDED|95.0|-12.45|7.35|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.35|-12.45|
74086731|NCT04243096|147727314|OTHER||Mean Difference (Final Values)|4.62|||<|0.0001|TWO_SIDED|95.0|2.6|6.64|||Mixed Models Analysis|||||6.64|2.60|<0.0001
73921294|NCT02801942|147370856|OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.957|||TWO_SIDED|95.0|-1.86|2.14|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.14|-1.86|
73921295|NCT02801942|147370856|OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|0.872|||TWO_SIDED|95.0|0.9|4.58|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.58|0.90|
73921296|NCT02801942|147370857|OTHER||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|1.344|||TWO_SIDED|95.0|-2.23|3.38|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.38|-2.23|
73921297|NCT02801942|147370857|OTHER||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|0.1|1.57|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|0.10|
73967460|NCT03498651|147472181|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_DEVIATION|0.02|||TWO_SIDED|95.0|-0.6|-0.51|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.51|-0.60|
73967461|NCT03498651|147472181|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.13|||TWO_SIDED|95.0|-0.23|0.27|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.27|-0.23|
73967462|NCT03498651|147472182|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.46|-0.37|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.37|-0.46|
73967463|NCT03498651|147472182|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.14|||TWO_SIDED|95.0|-0.23|0.32|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.32|-0.23|
73967464|NCT03498651|147472183|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.39|-0.27|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.27|-0.39|
74028157|NCT01380093|147610098|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9421|TWO_SIDED|95.0|-1.0|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.9|-1.0|0.9421
74028158|NCT01380093|147610098|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.1266|TWO_SIDED|95.0|-0.2|1.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.7|-0.2|0.1266
74028159|NCT01380093|147610099|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6||||0.0723|TWO_SIDED|95.0|-5.3|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-5.3|0.0723
74028160|NCT01380093|147610099|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.4515|TWO_SIDED|95.0|-1.7|3.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.8|-1.7|0.4515
73921298|NCT02801942|147370857|OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.594|||TWO_SIDED|95.0|-0.41|2.07|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.07|-0.41|
73921299|NCT02801942|147370857|OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|95.0|-1.54|0.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.92|-1.54|
73921300|NCT02801942|147370858|OTHER||Mean Difference (Final Values)|3.01|STANDARD_ERROR_OF_MEAN|1.728|||TWO_SIDED|95.0|-0.62|6.63|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.63|-0.62|
73921301|NCT02801942|147370858|OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|4.392|||TWO_SIDED|95.0|-11.33|7.21|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.21|-11.33|
73921302|NCT02801942|147370858|OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|2.042|||TWO_SIDED|95.0|-14.56|17.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||17.13|-14.56|
73921303|NCT02801942|147370858|OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|0.843|||TWO_SIDED|95.0|0.36|3.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.92|0.36|
73921304|NCT02801942|147370859|OTHER||Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|3.097|||TWO_SIDED|95.0|-4.24|8.83|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.83|-4.24|
73967465|NCT03498651|147472183|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.14|0.48|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.48|-0.14|
73921305|NCT02801942|147370859|OTHER||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|2.334|||TWO_SIDED|95.0|-0.47|9.39|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||9.39|-0.47|
73921306|NCT02801942|147370859|OTHER||Mean Difference (Final Values)|11.54|STANDARD_ERROR_OF_MEAN|7.693|||TWO_SIDED|95.0|-5.24|28.32|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||28.32|-5.24|
73921307|NCT02801942|147370859|OTHER||Mean Difference (Final Values)|5.64|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-7.73|19.01|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||19.01|-7.73|
73921308|NCT02801942|147370859|OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|3.336|||TWO_SIDED|95.0|-8.46|5.71|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.71|-8.46|
73921309|NCT02801942|147370859|OTHER||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|1.755|||TWO_SIDED|95.0|-5.54|1.98|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.98|-5.54|
73921310|NCT02801942|147370859|OTHER||Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-21.58|4.98|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.98|-21.58|
73921311|NCT02801942|147370859|OTHER||Mean Difference (Final Values)|-8.31|STANDARD_ERROR_OF_MEAN|6.019|||TWO_SIDED|95.0|-21.49|4.87|||||The mean difference in Naive B Lymphocytes by (Healthy participants versus NOT1D participants) core biopsy method has been presented.|||4.87|-21.49|
73921312|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|2.538|||TWO_SIDED|95.0|-0.54|10.48|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||10.48|-0.54|
73921313|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|95.0|-8.37|4.61|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.61|-8.37|
73921314|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|-0.26|0.54|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.54|-0.26|
73921315|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.147|||TWO_SIDED|95.0|-0.37|0.27|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.27|-0.37|
73921316|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.402|||TWO_SIDED|95.0|-1.27|0.49|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.49|-1.27|
73921317|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.312|||TWO_SIDED|95.0|-0.33|1.07|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.07|-0.33|
73967466|NCT01566695|147472195|SUPERIORITY||Rate Difference|18.9||||0.0005|TWO_SIDED|95.0|8.3|29.6||2 sided|Stratified Mantel-Haenszel Chi-squared|Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2||||29.6|8.3|0.0005
73967467|NCT01566695|147472199|SUPERIORITY||Rate Difference|21.6|||<|0.0001|TWO_SIDED|95.0|11.9|31.3||2 sided|Stratified Mantel-Haenszel; Chi-squared|Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2||||31.3|11.9|<0.0001
73967468|NCT01566695|147472200|SUPERIORITY|||||||0.4347|||||||Two-Sided Unstratified Log Rank Test|||||||0.4347
73921318|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|95.0|-0.16|0.13|||||The mean difference in CD56lo CD16- by (Healthy participants versus NOT1D participants) FNA method has been presented.|||0.13|-0.16|
73861477|NCT00098722|147268847|SUPERIORITY_OR_OTHER||LS mean difference|-1.042|STANDARD_ERROR_OF_MEAN|0.1786|||TWO_SIDED|97.5|-1.444|-0.64||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.640|-1.444|
73921319|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|95.0|-0.17|0.12|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.12|-0.17|
73921320|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED|95.0|-0.03|0.47|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.47|-0.03|
73921321|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|95.0|-0.59|0.4|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.40|-0.59|
73921322|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.766|||TWO_SIDED|95.0|-1.72|1.6|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.60|-1.72|
73921323|NCT02801942|147370860|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.417|||TWO_SIDED|95.0|-0.99|0.82|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.82|-0.99|
73921324|NCT02801942|147370861|OTHER||Mean Difference (Final Values)|13.72|STANDARD_ERROR_OF_MEAN|7.475|||TWO_SIDED|95.0|-2.72|30.15|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||30.15|-2.72|
73967469|NCT01566695|147472202|SUPERIORITY|HI-E|Rate Difference|10.9||||0.1467|TWO_SIDED|95.0|-2.0|23.7|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||23.7|-2.0|0.1467
73861478|NCT00098722|147268848|SUPERIORITY_OR_OTHER||LS mean difference|-0.961|STANDARD_ERROR_OF_MEAN|0.1856|||TWO_SIDED|97.5|-1.379|-0.544||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.544|-1.379|
73921325|NCT02801942|147370861|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|7.566|||TWO_SIDED|95.0|-16.85|16.78|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||16.78|-16.85|
73921326|NCT02801942|147370861|OTHER||Mean Difference (Final Values)|-20.03|STANDARD_ERROR_OF_MEAN|8.586|||TWO_SIDED|95.0|-38.98|-1.08|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.|||-1.08|-38.98|
73921327|NCT02801942|147370861|OTHER||Mean Difference (Final Values)|4.25|STANDARD_ERROR_OF_MEAN|12.739|||TWO_SIDED|95.0|-24.14|32.65|||||The mean difference in CD56lo CD16+ by (Healthy participants versus NOT1D participants) core biopsy method has been presented.|||32.65|-24.14|
73921328|NCT02801942|147370861|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|2.429|||TWO_SIDED|95.0|-5.54|5.26|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.26|-5.54|
73921329|NCT02801942|147370861|OTHER||Mean Difference (Final Values)|-2.79|STANDARD_ERROR_OF_MEAN|4.148|||TWO_SIDED|95.0|-12.31|6.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.73|-12.31|
73921330|NCT02801942|147370862|OTHER||Mean Difference (Final Values)|8.25|STANDARD_ERROR_OF_MEAN|7.673|||TWO_SIDED|95.0|-8.58|25.08|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||25.08|-8.58|
73921331|NCT02801942|147370862|OTHER||Mean Difference (Final Values)|16.22|STANDARD_ERROR_OF_MEAN|6.189|||TWO_SIDED|95.0|3.17|29.26|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||29.26|3.17|
73921332|NCT02801942|147370862|OTHER||Mean Difference (Final Values)|-7.89|STANDARD_ERROR_OF_MEAN|10.509|||TWO_SIDED|95.0|-31.03|15.25|||||The mean difference in Plasmacytoid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||15.25|-31.03|
73921333|NCT02801942|147370862|OTHER||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|5.781|||TWO_SIDED|95.0|-26.04|-1.66|||||The mean difference in (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||-1.66|-26.04|
73921334|NCT02801942|147370864|OTHER||Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|3.561|||TWO_SIDED|95.0|-9.05|5.82|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.82|-9.05|
73921335|NCT02801942|147370864|OTHER||Mean Difference (Final Values)|4.01|STANDARD_ERROR_OF_MEAN|3.418|||TWO_SIDED|95.0|-3.13|11.16|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||11.16|-3.13|
73921336|NCT02801942|147370864|OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|1.428|||TWO_SIDED|95.0|-3.14|2.82|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.82|-3.14|
73921337|NCT02801942|147370864|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|1.851|||TWO_SIDED|95.0|-5.03|2.71|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.71|-5.03|
73921338|NCT02801942|147370864|OTHER||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|3.132|||TWO_SIDED|95.0|-8.65|4.43|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.43|-8.65|
73921339|NCT02801942|147370864|OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|3.071|||TWO_SIDED|95.0|-8.0|4.81|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.81|-8.00|
73921340|NCT02801942|147370864|OTHER||Mean Difference (Final Values)|3.51|STANDARD_ERROR_OF_MEAN|6.594|||TWO_SIDED|95.0|-10.21|17.24|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||17.24|-10.21|
74086732|NCT04243096|147727315|OTHER||Mean Difference (Final Values)|-0.04|||<|0.0001|TWO_SIDED|95.0|-0.06|-0.02|||Mixed Models Analysis|||||-0.02|-0.06|<0.0001
73921341|NCT02801942|147370864|OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|7.155|||TWO_SIDED|95.0|-17.1|12.74|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||12.74|-17.10|
73921342|NCT02801942|147370864|OTHER||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.708|||TWO_SIDED|95.0|-2.42|0.58|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.58|-2.42|
73967470|NCT01566695|147472202|SUPERIORITY|≥ 1.5 g/dL Hemoglobin Increase|Rate Diffrence|17.9||||0.0002|TWO_SIDED|95.0|8.8|26.9|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||26.9|8.8|0.0002
73967471|NCT01566695|147472202|SUPERIORITY|RBC Transfusion Reduction|Rate Difference|10.9||||0.1431|TWO_SIDED|95.0|-1.9|23.6|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||23.6|-1.9|0.1431
73967472|NCT01566695|147472203|SUPERIORITY||Rate Difference|17.0||||0.0007|TWO_SIDED|95.0|7.5|26.4|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||26.4|7.5|0.0007
74086733|NCT04243096|147727316|OTHER||Mean Difference (Final Values)|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.01|||Mixed Models Analysis|||||-0.01|-0.03|<0.0001
74086734|NCT04243096|147727317|OTHER||Mean Difference (Final Values)|-0.03|||<|0.0001|TWO_SIDED|95.0|-0.04|-0.02|||Mixed Models Analysis|||||-0.02|-0.04|<0.0001
74086735|NCT04243096|147727318|OTHER||Mean Difference (Final Values)|-0.01|||<|0.0001|TWO_SIDED|95.0|-0.01|0.0|||Mixed Models Analysis|||||0.00|-0.01|<0.0001
74086736|NCT04243096|147727319|OTHER||Mean Difference (Final Values)|-0.01||||0.0013|TWO_SIDED|95.0|-0.02|-0.01|||Mixed Models Analysis|||||-0.01|-0.02|0.0013
73921343|NCT02801942|147370864|OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.372|||TWO_SIDED|95.0|-1.19|0.35|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.35|-1.19|
73921344|NCT02801942|147370866|OTHER||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|2.545|||TWO_SIDED|95.0|-11.56|0.78|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.78|-11.56|
73921345|NCT02801942|147370866|OTHER||Mean Difference (Final Values)|-7.03|STANDARD_ERROR_OF_MEAN|7.114|||TWO_SIDED|95.0|-22.22|8.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy FNA method has been presented.|||8.16|-22.22|
73967473|NCT01566695|147472206|OTHER||Hazard Ratio (HR)|1.08||||0.6257|TWO_SIDED|95.0|0.79|1.49|||Log Rank||||Cox proportional hazards model with stratifies factors|1.49|0.79|0.6257
73967474|NCT01566695|147472212|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.214
73967475|NCT01566695|147472213|SUPERIORITY|||||||0.446|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.446
73967476|NCT01566695|147472214|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.248
73967477|NCT01566695|147472215|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.058
74086737|NCT04243096|147727320|OTHER||Mean Difference (Final Values)|-0.02||||0.0003|TWO_SIDED|95.0|-0.02|-0.01|||Mixed Models Analysis|||||-0.01|-0.02|0.0003
74086738|NCT04243096|147727321|OTHER||Mean Difference (Final Values)|0.03|||<|0.0001|TWO_SIDED|95.0|0.02|0.04|||Mixed Models Analysis|||||0.04|0.02|<0.0001
74086739|NCT04243096|147727322|OTHER||Mean Difference (Final Values)|0.09|||<|0.0001|TWO_SIDED|95.0|0.06|0.13|||Mixed Models Analysis|||||0.13|0.06|<0.0001
74086740|NCT04243096|147727326|OTHER||Mean Difference (Final Values)|9.96|||<|0.0001|TWO_SIDED|95.0|6.6|13.31|||Mixed Models Analysis|||||13.31|6.60|<0.0001
74086741|NCT04243096|147727327|OTHER||Mean Difference (Final Values)|13.07|||<|0.0001|TWO_SIDED|95.0|9.65|16.48|||Mixed Models Analysis|adjusted for age, sex, BMI, and presence of comorbidities.|Change from baseline to week 12|||16.48|9.65|<0.0001
74086742|NCT04243096|147727328|OTHER||Median Difference (Final Values)|-17.5||||0.1196|TWO_SIDED|95.0|-39.7|4.61|||Mixed Models Analysis|||||4.61|-39.7|0.1196
74086743|NCT04243096|147727330|OTHER||Mean Difference (Final Values)|0.11|||<|0.0001|TWO_SIDED|95.0|-0.04|0.25|||Mixed Models Analysis|||||0.25|-0.04|<0.0001
74086744|NCT04243096|147727331|OTHER||Mean Difference (Final Values)|-1.83|||<|0.0001|TWO_SIDED|95.0|-5.76|2.09|||Mixed Models Analysis|||||2.09|-5.76|<0.0001
74086745|NCT04243096|147727332|OTHER||Mean Difference (Final Values)|-0.15|||<|0.0001|TWO_SIDED|95.0|-0.46|0.16|||Mixed Models Analysis|||||0.16|-0.46|<0.0001
74086746|NCT04243096|147727333|OTHER||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-2.22|-0.08|||Mixed Models Analysis|||||-0.08|-2.22|<0.0001
74086747|NCT04243096|147727334|OTHER||Mean Difference (Final Values)|-0.08|||<|0.0001|TWO_SIDED|95.0|-3.37|3.22|||Mixed Models Analysis|||||3.22|-3.37|<0.0001
74086748|NCT04243096|147727335|OTHER||Mean Difference (Final Values)|6.21||||0.0134|TWO_SIDED|95.0|1.31|11.11|||Mixed Models Analysis|||||11.11|1.31|0.0134
74086749|NCT04243096|147727336|OTHER||Median Difference (Final Values)|1.75|||<|0.0001|TWO_SIDED|95.0|1.16|2.34|||Mixed Models Analysis|||||2.34|1.16|<0.0001
74086750|NCT04243096|147727337|OTHER||Median Difference (Final Values)|-1.19||||0.003|TWO_SIDED|95.0|-1.97|-0.41|||Mixed Models Analysis|||||-0.41|-1.97|0.0030
74086751|NCT04243096|147727338|OTHER||Mean Difference (Final Values)|0.45|||<|0.0001|TWO_SIDED|95.0|0.23|0.67|||Mixed Models Analysis|||||0.67|0.23|<0.0001
74086752|NCT04243096|147727339|OTHER||Mean Difference (Final Values)|35.18|||<|0.0001|TWO_SIDED|95.0|18.7|51.67|||Mixed Models Analysis|||||51.67|18.70|<0.0001
74086753|NCT04243096|147727340|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.57|-1.39|||Mixed Models Analysis|||||-1.39|-2.57|<0.0001
73861479|NCT00098722|147268848|SUPERIORITY_OR_OTHER||LS mean difference|-1.109|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|97.5|-1.523|-0.695||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.695|-1.523|
73921346|NCT02801942|147370867|OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.358|||TWO_SIDED|95.0|-0.36|1.14|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.14|-0.36|
73921347|NCT02801942|147370867|OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|95.0|-0.25|0.52|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.52|-0.25|
73921348|NCT02801942|147370867|OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-9.02|8.64|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.64|-9.02|
73921349|NCT02801942|147370867|OTHER||Mean Difference (Final Values)|-3.72|STANDARD_ERROR_OF_MEAN|4.223|||TWO_SIDED|95.0|-12.57|5.13|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.13|-12.57|
73921350|NCT02801942|147370867|OTHER||Mean Difference (Final Values)|2.25|STANDARD_ERROR_OF_MEAN|4.034|||TWO_SIDED|95.0|-6.16|10.66|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||10.66|-6.16|
73861480|NCT00098722|147268849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|95.0|2.56|8.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \[\<\] 100,000 or greater than or equal to \[\>=\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\>) 1 favors maraviroc.||8.23|2.56|<0.0001
73861481|NCT00098722|147268849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.01|||<|0.0001|TWO_SIDED|95.0|3.35|10.78|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||10.78|3.35|<0.0001
73861482|NCT00098722|147268849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||<|0.0001|TWO_SIDED|95.0|2.25|7.2|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.20|2.25|<0.0001
73861483|NCT00098722|147268849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.47|7.85|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.85|2.47|<0.0001
73861484|NCT00098722|147268850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.69|||<|0.0001|TWO_SIDED|95.0|2.72|8.1|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.10|2.72|<0.0001
73861485|NCT00098722|147268850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.01|||<|0.0001|TWO_SIDED|95.0|2.91|8.62|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.62|2.91|<0.0001
73861486|NCT00098722|147268850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.13|6.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.32|2.13|<0.0001
73861487|NCT00098722|147268850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.64|||<|0.0001|TWO_SIDED|95.0|2.69|8.02|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.02|2.69|<0.0001
73861488|NCT00098722|147268851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|2.64|7.92|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.92|2.64|<0.0001
73861489|NCT00098722|147268851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.42|||<|0.0001|TWO_SIDED|95.0|3.13|9.39|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||9.39|3.13|<0.0001
73861490|NCT00098722|147268851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.29|7.0|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.00|2.29|<0.0001
73921351|NCT02801942|147370867|OTHER||Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|3.994|||TWO_SIDED|95.0|-6.27|10.39|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.39|-6.27|
73921352|NCT02801942|147370867|OTHER||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|5.727|||TWO_SIDED|95.0|-14.09|9.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.92|-14.09|
73921353|NCT02801942|147370867|OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|4.976|||TWO_SIDED|95.0|-9.91|10.87|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.87|-9.91|
73921354|NCT02801942|147370867|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.314|||TWO_SIDED|95.0|-0.67|0.65|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.65|-0.67|
73921355|NCT02801942|147370867|OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.325|||TWO_SIDED|95.0|-1.1|0.26|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.26|-1.10|
73921356|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|4.671|||TWO_SIDED|95.0|-2.8|16.81|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||16.81|-2.80|
74028161|NCT01380093|147610099|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.0121|TWO_SIDED|95.0|0.8|6.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||6.4|0.8|0.0121
74086754|NCT02792218|147727356|SUPERIORITY||rate ratio|0.495|||<|0.001|TWO_SIDED|95.0|0.375|0.655|||negative binomial regression model|||Obtained from fitting a negative binomial regression model with log-link to the number of relapses, adjusted for treatment and region as factors, number of relapses in previous year, baseline EDSS, baseline number of Gd-enhancing lesions and the patient's age at baseline as covariates. The natural log of the time-in-study was used as offset to annualize the relapse rate.||0.655|0.375|<0.001
73921357|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|-3.93|STANDARD_ERROR_OF_MEAN|4.828|||TWO_SIDED|95.0|-14.02|6.17|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.17|-14.02|
73921358|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.651|||TWO_SIDED|95.0|-2.69|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.16|-2.69|
73921359|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|1.507|||TWO_SIDED|95.0|-3.21|3.24|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.24|-3.21|
73921360|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|95.0|-2.78|4.33|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.33|-2.78|
73921361|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.339|||TWO_SIDED|95.0|-2.75|2.85|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.85|-2.75|
74028162|NCT01380093|147610100|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.0||||0.0059|TWO_SIDED|95.0|-18.7|-3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.3|-18.7|0.0059
74086755|NCT02792218|147727357|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.003|TWO_SIDED|95.0|0.5|0.863|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.863|0.500|0.003
73921362|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|3.631|||TWO_SIDED|95.0|-8.56|6.63|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.63|-8.56|
73921363|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|-6.03|STANDARD_ERROR_OF_MEAN|2.708|||TWO_SIDED|95.0|-11.69|-0.38|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||-0.38|-11.69|
73921364|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.889|||TWO_SIDED|95.0|-1.98|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.78|-1.98|
73921365|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.787|||TWO_SIDED|95.0|-1.07|2.24|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.24|-1.07|
73921366|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.613|||TWO_SIDED|95.0|-0.85|1.72|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.72|-0.85|
73921367|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|95.0|-0.8|1.56|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.56|-0.80|
73921368|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|1.546|||TWO_SIDED|95.0|-2.71|3.76|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.76|-2.71|
73921369|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-2.95|3.79|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.79|-2.95|
73921370|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.356|||TWO_SIDED|95.0|-4.84|9.14|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.14|-4.84|
73921371|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|2.481|||TWO_SIDED|95.0|-1.25|9.15|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||9.15|-1.25|
73921372|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.627|||TWO_SIDED|95.0|-1.28|1.38|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.38|-1.28|
73921373|NCT02801942|147370868|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.438|||TWO_SIDED|95.0|-0.93|0.91|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.91|-0.93|
73921374|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-7.4|8.0|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.00|-7.40|
73921375|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|2.694|||TWO_SIDED|95.0|-4.9|6.35|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.35|-4.90|
73921376|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|2.377|||TWO_SIDED|95.0|-9.89|0.08|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.08|-9.89|
73921377|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|-3.29|STANDARD_ERROR_OF_MEAN|1.682|||TWO_SIDED|95.0|-6.82|0.24|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.24|-6.82|
73921378|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|95.0|-2.67|2.1|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.10|-2.67|
73921379|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|1.929|||TWO_SIDED|95.0|-7.2|1.59|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.59|-7.20|
73921380|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|2.117|||TWO_SIDED|95.0|-5.98|3.11|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.11|-5.98|
73921381|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.047|||TWO_SIDED|95.0|-4.59|3.99|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.99|-4.59|
73921382|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|2.645|||TWO_SIDED|95.0|-6.99|4.06|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.06|-6.99|
73921383|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|2.185|||TWO_SIDED|95.0|-4.05|5.11|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.11|-4.05|
73921384|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|4.299|||TWO_SIDED|95.0|-11.23|6.73|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.73|-11.23|
73921385|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|3.42|STANDARD_ERROR_OF_MEAN|3.472|||TWO_SIDED|95.0|-3.84|10.67|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.67|-3.84|
73967478|NCT01566695|147472216|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.130
73967479|NCT01566695|147472217|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.123
73967480|NCT01566695|147472218|SUPERIORITY|||||||0.069|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.069
73967481|NCT01566695|147472219|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.078
73967482|NCT01566695|147472220|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.073
73967483|NCT01566695|147472221|SUPERIORITY||Common Odds Raatio|0.77||||0.56|TWO_SIDED|95.0|0.54|1.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|1.30|0.54|0.560
73967484|NCT01566695|147472222|SUPERIORITY||Common Odds Raatio|0.72||||0.48|TWO_SIDED|95.0|0.29|1.78|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|1.78|0.29|0.480
73967485|NCT01566695|147472223|SUPERIORITY||Common Odds Ratio|1.67||||0.197|TWO_SIDED|95.0|0.76|3.65|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.65|0.76|0.197
73967486|NCT01566695|147472224|SUPERIORITY||Common Odds Ratio|2.14||||0.121|TWO_SIDED|95.0|0.82|5.57|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|5.57|0.82|0.121
73967487|NCT01566695|147472225|SUPERIORITY||Common Odds Ratio|2.0||||0.075|TWO_SIDED|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.30|0.93|0.075
73967488|NCT01566695|147472226|SUPERIORITY||Common Odds Ratio|1.58||||0.222|TWO_SIDED|95.0|0.76|3.29|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.29|0.76|0.222
74028163|NCT01380093|147610100|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.28|TWO_SIDED|95.0|-3.5|11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.8|-3.5|0.2800
73921386|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|1.153|||TWO_SIDED|95.0|-3.3|2.0|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.00|-3.30|
73921387|NCT02801942|147370869|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.869|||TWO_SIDED|95.0|-2.06|1.72|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.72|-2.06|
73921388|NCT02801942|147370870|OTHER||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|1.304|||TWO_SIDED|95.0|-2.27|3.19|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.19|-2.27|
73921389|NCT02801942|147370870|OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.056|||TWO_SIDED|95.0|-3.24|1.36|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.36|-3.24|
73921390|NCT02801942|147370871|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|5.069|||TWO_SIDED|95.0|-11.91|9.58|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.58|-11.91|
73967489|NCT01566695|147472227|SUPERIORITY||Common Odds Ratio|1.65||||0.249|TWO_SIDED|95.0|0.71|3.83|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.83|0.71|0.249
73967490|NCT01566695|147472228|SUPERIORITY||Common Odds Ratio|2.03||||0.082|TWO_SIDED|95.0|0.92|4.48|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.48|0.92|0.082
73921391|NCT02801942|147370871|OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|5.301|||TWO_SIDED|95.0|-15.85|7.1|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||7.10|-15.85|
73921392|NCT02801942|147370871|OTHER||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|1.374|||TWO_SIDED|95.0|-1.62|4.59|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.59|-1.62|
73921393|NCT02801942|147370871|OTHER||Mean Difference (Final Values)|2.91|STANDARD_ERROR_OF_MEAN|1.291|||TWO_SIDED|95.0|-0.05|5.88|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.88|-0.05|
73921394|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|4.86|STANDARD_ERROR_OF_MEAN|3.083|||TWO_SIDED|95.0|-1.6|11.31|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||11.31|-1.60|
74028164|NCT01380093|147610100|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1||||0.0002|TWO_SIDED|95.0|7.5|22.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||22.8|7.5|0.0002
73921395|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|8.21|STANDARD_ERROR_OF_MEAN|6.78|||TWO_SIDED|95.0|-6.15|22.57|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||22.57|-6.15|
73921396|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|-11.19|STANDARD_ERROR_OF_MEAN|5.812|||TWO_SIDED|95.0|-23.48|1.11|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.11|-23.48|
73921397|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|-5.89|STANDARD_ERROR_OF_MEAN|3.855|||TWO_SIDED|95.0|-14.14|2.37|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.37|-14.14|
73921398|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|1.65|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|95.0|-3.54|6.84|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.84|-3.54|
73921399|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|2.57|STANDARD_ERROR_OF_MEAN|2.937|||TWO_SIDED|95.0|-3.84|8.98|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||8.98|-3.84|
73921400|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|2.781|||TWO_SIDED|95.0|-2.67|9.12|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.12|-2.67|
73921401|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|1.337|||TWO_SIDED|95.0|0.55|6.21|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.21|0.55|
73921402|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|4.736|||TWO_SIDED|95.0|-11.49|8.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.58|-11.49|
73921403|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|1.88|STANDARD_ERROR_OF_MEAN|4.142|||TWO_SIDED|95.0|-6.81|10.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.58|-6.81|
73921404|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|10.45|STANDARD_ERROR_OF_MEAN|5.79|||TWO_SIDED|95.0|-2.01|22.92|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||22.92|-2.01|
73921405|NCT02801942|147370872|OTHER||Mean Difference (Final Values)|6.17|STANDARD_ERROR_OF_MEAN|4.913|||TWO_SIDED|95.0|-4.24|16.59|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||16.59|-4.24|
73921406|NCT02801942|147370873|OTHER||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|0.696|||TWO_SIDED|95.0|-0.08|2.83|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.83|-0.08|
73921407|NCT02801942|147370873|OTHER||Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|1.324|||TWO_SIDED|95.0|-0.61|4.98|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.98|-0.61|
73967491|NCT01566695|147472229|SUPERIORITY||Common Odds Ratio|1.86||||0.153|TWO_SIDED|95.0|0.79|4.34|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.34|0.79|0.153
73921408|NCT02801942|147370873|OTHER||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|6.389|||TWO_SIDED|95.0|-14.66|12.85|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||12.85|-14.66|
73921409|NCT02801942|147370873|OTHER||Mean Difference (Final Values)|-4.19|STANDARD_ERROR_OF_MEAN|4.862|||TWO_SIDED|95.0|-14.71|6.33|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.33|-14.71|
73921410|NCT02801942|147370873|OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.234|||TWO_SIDED|95.0|-2.73|2.47|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.47|-2.73|
73921411|NCT02801942|147370873|OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.859|||TWO_SIDED|95.0|-1.45|2.28|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.28|-1.45|
73967492|NCT01566695|147472230|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73921412|NCT02801942|147370873|OTHER||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|1.205|||TWO_SIDED|95.0|0.64|5.78|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.78|0.64|
73921413|NCT02801942|147370873|OTHER||Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|0.712|||TWO_SIDED|95.0|0.75|3.79|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.79|0.75|
73921414|NCT02801942|147370874|OTHER||Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|0.4|6.15|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.15|0.40|
73921415|NCT02801942|147370874|OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|2.109|||TWO_SIDED|95.0|-1.68|7.17|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||7.17|-1.68|
73921416|NCT02801942|147370874|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|6.712|||TWO_SIDED|95.0|-14.49|14.48|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||14.48|-14.49|
73921417|NCT02801942|147370874|OTHER||Mean Difference (Final Values)|-4.12|STANDARD_ERROR_OF_MEAN|3.947|||TWO_SIDED|95.0|-12.67|4.43|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.43|-12.67|
73921418|NCT02801942|147370874|OTHER||Mean Difference (Final Values)|1.33|STANDARD_ERROR_OF_MEAN|2.967|||TWO_SIDED|95.0|-5.48|8.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.13|-5.48|
73921419|NCT02801942|147370874|OTHER||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|2.287|||TWO_SIDED|95.0|-4.36|6.84|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.84|-4.36|
73921420|NCT02801942|147370874|OTHER||Mean Difference (Final Values)|2.69|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|95.0|0.54|4.84|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.84|0.54|
73921421|NCT02801942|147370874|OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|0.737|||TWO_SIDED|95.0|0.03|3.13|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.13|0.03|
73921422|NCT03182829|147370907|NON_INFERIORITY|non-inferiority was chosen|Mean Difference (Final Values)|100.0|||<|0.05|TWO_SIDED|95.0|90.0|100.0|||Chi-squared||||Fisher's exact test|100|90|<0.05
73921423|NCT00254540|147370908|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|48.0||||||95.0|27.8|68.7||||||||68.7|27.8|
73967493|NCT01566695|147472231|SUPERIORITY|||||||0.046|||||||Fisher Exact|||||||0.046
73967494|NCT01566695|147472232|SUPERIORITY|||||||0.134|||||||Fisher Exact|||||||0.134
73967495|NCT01566695|147472233|SUPERIORITY|||||||0.324|||||||Fisher Exact|||||||0.324
73967496|NCT01566695|147472234|SUPERIORITY|||||||0.442|||||||Fisher Exact|||||||0.442
73967497|NCT01566695|147472235|SUPERIORITY|||||||0.063|||||||Fisher Exact|||||||0.063
73967498|NCT01566695|147472236|SUPERIORITY|||||||0.198|||||||Fisher Exact|||||||0.198
73967499|NCT01566695|147472237|SUPERIORITY|||||||0.972|||||||Fisher Exact|||||||0.972
73967500|NCT01566695|147472238|SUPERIORITY|||||||0.601|||||||Fisher Exact|||||||0.601
73967501|NCT01566695|147472239|SUPERIORITY|||||||0.07|||||||Fisher Exact|||||||0.070
73921424|NCT00254540|147370908|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|46.2||||||95.0|26.6|66.6||||||||66.6|26.6|
73921425|NCT00225251|147370924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|||<|0.05|||||||t-test, 2 sided|||||||<.05
73921426|NCT01313767|147370941|NON_INFERIORITY_OR_EQUIVALENCE|90% of the power, 0.45 of non-inferiority margin|Mean Difference (Final Values)|0.17||||0.1347|TWO_SIDED|95.0|-0.05|0.4|||t-test, 2 sided|||The difference between the two groups was provided with 95% CI. If the upper limit of CI is no greater than 0.45 (non-inferiority margin), the study group was determined not inferior to the control group. Additionally, difference between groups in change from baseline to week 4 in wrist flexor MAS score was compared using two sample t-test.||0.40|-0.05|0.1347
73921427|NCT01313767|147370942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.2591|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in wrist flexor MAS score was compared using two sample t-test.||||0.2591
73921428|NCT01313767|147370942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.3395|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in wrist flexor MAS score was compared using two sample t-test.||||0.3395
73921429|NCT01313767|147370943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0675|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in elbow flexor MAS score was compared using two sample t-test.||||0.0675
73921430|NCT01313767|147370943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0605|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in elbow flexor MAS score was compared using two sample t-test.||||0.0605
73921431|NCT01313767|147370943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.0429|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in elbow flexor MAS score was compared using two sample t-test.||||0.0429
73921432|NCT01313767|147370944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.6954|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in finger flexor MAS score was compared using two sample t-test.||||0.6954
73921433|NCT01313767|147370944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.6024|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in finger flexor MAS score was compared using two sample t-test.||||0.6024
73921434|NCT01313767|147370944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9316|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in finger flexor MAS score was compared using two sample t-test.||||0.9316
73967502|NCT01566695|147472240|SUPERIORITY|||||||0.436|||||||Fisher Exact|||||||0.436
73967503|NCT01566695|147472241|SUPERIORITY|||||||0.683|||||||Fisher Exact|||||||0.683
73967504|NCT05956002|147472245|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.66|||||TWO_SIDED|90.0|91.33|98.12|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2mg mini tablets in applesauce vs etrasimod 2mg clinical IR tablet mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.12|91.33|
74028165|NCT01380093|147610101|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.7||||0.0001|TWO_SIDED|95.0|-54.8|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.6|-54.8|0.0001
73921435|NCT01313767|147370945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.2284|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in thumb flexor MAS score was compared using two sample t-test.||||0.2284
73921436|NCT01313767|147370945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.3221|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in thumb flexor MAS score was compared using two sample t-test.||||0.3221
73921437|NCT01313767|147370945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.593|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in thumb flexor MAS score was compared using two sample t-test.||||0.5930
73921438|NCT01313767|147370946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.1585|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.1585
73921439|NCT01313767|147370946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0028||||0.9596|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.9596
73921440|NCT01313767|147370946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0304||||0.6164|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.6164
73921441|NCT01313767|147370947|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.098||||0.1802|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1802
73921442|NCT01313767|147370947|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1164||||0.1176|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1176
73921443|NCT01313767|147370947|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1138||||0.1252|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1252
73921444|NCT01313767|147370948|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.098||||0.3431|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in finger flexor was compared using Pearson's chi-square test.||||0.3431
73921445|NCT01313767|147370948|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1097||||0.1329|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in finger flexor was compared using Pearson's chi-square test||||0.1329
73921446|NCT01313767|147370948|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0853||||0.2611|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in finger flexor was compared using Pearson's chi-square test||||0.2611
73921447|NCT01313767|147370949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0654||||0.4623|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.4623
73921448|NCT01313767|147370949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1194||||0.2007|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.2007
73921449|NCT01313767|147370949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0172||||0.8553|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.8553
73921450|NCT01313767|147370950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.604|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.6040
73921451|NCT01313767|147370950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.3233|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.3233
73921452|NCT01313767|147370950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.4469|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.4469
73921453|NCT01313767|147370951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.122|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.1220
73921454|NCT01313767|147370951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.1016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.1016
73921455|NCT01313767|147370951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.2235|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.2235
73921456|NCT01313767|147370952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.503|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.5030
73921457|NCT01313767|147370952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.6934|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.6934
73921458|NCT01313767|147370952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9574|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.9574
74028166|NCT01380093|147610101|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2||||0.1488|TWO_SIDED|95.0|-4.8|31.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||31.2|-4.8|0.1488
73921459|NCT01313767|147370953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.7237|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of pain was compared using wilcoxon rank sum test.||||0.7237
73921460|NCT01313767|147370953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.7237|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of pain was compared using wilcoxon rank sum test.||||0.7237
73921461|NCT01313767|147370953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.4017|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of pain was compared using wilcoxon rank sum test.||||0.4017
73921462|NCT01313767|147370954|SUPERIORITY_OR_OTHER|||||||0.2346|TWO_SIDED||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.||||0.2346
73921463|NCT01313767|147370955|SUPERIORITY_OR_OTHER|||||||0.9513|TWO_SIDED||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.||||0.9513
73921464|NCT01313767|147370956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8088|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.8088
73921465|NCT01313767|147370956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.3702|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.3702
73921466|NCT01313767|147370956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.1497|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.1497
73921467|NCT01313767|147370957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.9634|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.9634
73921468|NCT01313767|147370957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.7302|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.7302
73921469|NCT01313767|147370957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.7715|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.7715
73921470|NCT01313767|147370958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9362|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.9362
73921471|NCT01313767|147370958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.7998|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.7998
73921472|NCT01313767|147370958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.5436|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.5436
73921473|NCT01313767|147370959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.7014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.7014
73921474|NCT01313767|147370959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8884|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.8884
73921475|NCT01313767|147370959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.284|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.2840
73921476|NCT01287897|147370960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|10.5||0.3406|TWO_SIDED|90.0|-13.0|21.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|Generalized linear mixed model (GLMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||21.7|-13.0|0.3406
73921477|NCT01287897|147370960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|11.0||0.0438|TWO_SIDED|90.0|0.7|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||36.7|0.7|0.0438
73921478|NCT01287897|147370961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|STANDARD_ERROR_OF_MEAN|13.6||0.2258|TWO_SIDED|90.0|-12.1|32.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||32.6|-12.1|0.2258
73921479|NCT01287897|147370962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|10.5||0.2627|TWO_SIDED|90.0|-10.6|23.9||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||23.9|-10.6|0.2627
74086756|NCT02792218|147727358|SUPERIORITY||Hazard Ratio (HR)|0.652||||0.029|TWO_SIDED|95.0|0.445|0.956|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.956|0.445|0.029
73921480|NCT01287897|147370962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.8|STANDARD_ERROR_OF_MEAN|10.9||0.0425|TWO_SIDED|90.0|0.8|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||36.7|0.8|0.0425
73921481|NCT01287897|147370963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1|STANDARD_ERROR_OF_MEAN|13.7||0.1362|TWO_SIDED|90.0|-7.5|37.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||37.6|-7.5|0.1362
74086757|NCT02792218|147727359|SUPERIORITY||Hazard Ratio (HR)|0.676||||0.012|TWO_SIDED|95.0|0.498|0.917|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.917|0.498|0.012
73921482|NCT01287897|147370964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|7.0||0.1527|TWO_SIDED|90.0|-4.3|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 2.||18.6|-4.3|0.1527
73921483|NCT01287897|147370964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.1|STANDARD_ERROR_OF_MEAN|9.1||0.0235|TWO_SIDED|90.0|3.1|33.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 4.||33.2|3.1|0.0235
73921484|NCT01287897|147370964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|9.9||0.0792|TWO_SIDED|90.0|-2.3|30.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 6.||30.2|-2.3|0.0792
73921485|NCT01287897|147370964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|STANDARD_ERROR_OF_MEAN|11.0||0.1909||90.0|-8.4|27.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 10.||27.6|-8.4|0.1909
73921486|NCT01287897|147370964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|6.8||0.1981|TWO_SIDED|90.0|-5.4|17.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 2.||17.0|-5.4|0.1981
73921487|NCT01287897|147370964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|STANDARD_ERROR_OF_MEAN|9.3||0.0132|TWO_SIDED|90.0|5.3|35.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 4.||35.8|5.3|0.0132
74086758|NCT02792218|147727360|SUPERIORITY||Hazard Ratio (HR)|0.607||||0.022|TWO_SIDED|95.0|0.396|0.93|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.930|0.396|0.022
73921488|NCT01287897|147370964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1|STANDARD_ERROR_OF_MEAN|10.1||0.0063|TWO_SIDED|90.0|8.6|41.7|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 6.||41.7|8.6|0.0063
73921489|NCT01287897|147370964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.7|STANDARD_ERROR_OF_MEAN|11.2||0.0138|TWO_SIDED|90.0|6.2|43.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 10.||43.1|6.2|0.0138
73921490|NCT01287897|147370965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4|STANDARD_ERROR_OF_MEAN|10.2||0.0662|TWO_SIDED|90.0|-1.4|32.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 2.||32.1|-1.4|0.0662
73921491|NCT01287897|147370965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.5|STANDARD_ERROR_OF_MEAN|10.0||0.1708|TWO_SIDED|90.0|-6.9|25.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 4.||25.8|-6.9|0.1708
73921492|NCT01287897|147370965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|11.1||0.2416|TWO_SIDED|90.0|-10.5|26.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 6.||26.0|-10.5|0.2416
73921493|NCT01287897|147370965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.1|STANDARD_ERROR_OF_MEAN|14.1||0.088|TWO_SIDED|90.0|-4.1|42.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 10.||42.3|-4.1|0.0880
73967505|NCT05956002|147472245|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.96|||||TWO_SIDED|90.0|91.69|98.34|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.34|91.69|
73921494|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|3.2||0.261|TWO_SIDED|90.0|-3.2|7.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 2.||7.2|-3.2|0.2610
73921495|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.8||0.4291|TWO_SIDED|90.0|-5.6|7.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 4.||7.0|-5.6|0.4291
73921496|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|6.0||0.5791|TWO_SIDED|90.0|-11.0|8.6|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 6.||8.6|-11.0|0.5791
73921497|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|8.0||0.7544|TWO_SIDED|90.0|-18.8|7.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 8.||7.7|-18.8|0.7544
73921498|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|9.2||0.2308||90.0|-8.3|21.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 10.||21.9|-8.3|0.2308
73921499|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|7.1||0.5038|TWO_SIDED|90.0|-11.8|11.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 12.||11.7|-11.8|0.5038
73921500|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|4.9||0.0498|TWO_SIDED|90.0|0.0|16.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 2.||16.0|0.0|0.0498
73921501|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.3|STANDARD_ERROR_OF_MEAN|7.6||0.0155|TWO_SIDED|90.0|3.9|28.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 4.||28.7|3.9|0.0155
73921502|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|8.5||0.0399|TWO_SIDED|90.0|0.9|28.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 6.||28.9|0.9|0.0399
73921503|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|9.6||0.1866|TWO_SIDED|90.0|-7.2|24.3|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 8.||24.3|-7.2|0.1866
73921504|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|10.3||0.0415|TWO_SIDED|90.0|0.9|34.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 10.||34.7|0.9|0.0415
73921505|NCT01287897|147370966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|9.5||0.0408|TWO_SIDED|90.0|0.9|32.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 12.||32.1|0.9|0.0408
73967506|NCT05956002|147472245|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|85.86|||||TWO_SIDED|90.0|82.9|88.92|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||88.92|82.90|
73861491|NCT00098722|147268851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.08|||<|0.0001|TWO_SIDED|95.0|2.91|8.89|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.89|2.91|<0.0001
73861492|NCT00098722|147268852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55|||<|0.0001|TWO_SIDED|95.0|1.95|6.48|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.48|1.95|<0.0001
73921506|NCT01287897|147370967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|5.3||0.1342|TWO_SIDED|90.0|-2.8|14.5|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 2.||14.5|-2.8|0.1342
73921507|NCT01287897|147370967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|4.3||0.2623|TWO_SIDED|90.0|-4.3|9.8|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 4.||9.8|-4.3|0.2623
73921508|NCT01287897|147370967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|6.3||0.3324|TWO_SIDED|90.0|-7.7|13.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 6.||13.2|-7.7|0.3324
73921509|NCT01287897|147370967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|7.5||0.6637|TWO_SIDED|90.0|-15.5|9.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 8.||9.1|-15.5|0.6637
73921510|NCT01287897|147370967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|9.0||0.2721||90.0|-9.3|20.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 10.||20.2|-9.3|0.2721
73921511|NCT01287897|147370967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|7.8||0.3022|TWO_SIDED|90.0|-8.8|16.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 12.||16.9|-8.8|0.3022
73921512|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|7.0||0.2687|TWO_SIDED|90.0|-7.2|15.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 2.||15.8|-7.2|0.2687
73921513|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|7.4||0.246|TWO_SIDED|90.0|-7.1|17.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 4.||17.3|-7.1|0.2460
73921514|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.2|STANDARD_ERROR_OF_MEAN|9.3||0.0633|TWO_SIDED|90.0|-1.1|29.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 6.||29.5|-1.1|0.0633
73921515|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|9.9||0.4036|TWO_SIDED|90.0|-13.8|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 8.||18.6|-13.8|0.4036
73921516|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|10.2||0.1921||90.0|-7.9|25.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 10.||25.6|-7.9|0.1921
73921517|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.5|STANDARD_ERROR_OF_MEAN|10.3||0.1541|TWO_SIDED|90.0|-6.5|27.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 12.||27.5|-6.5|0.1541
73921518|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|6.5||0.4893|TWO_SIDED|90.0|-10.5|10.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 2.||10.9|-10.5|0.4893
73921519|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|STANDARD_ERROR_OF_MEAN|8.6||0.0619|TWO_SIDED|90.0|-0.9|27.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 4.||27.4|-0.9|0.0619
73921520|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.7|STANDARD_ERROR_OF_MEAN|9.3||0.029|TWO_SIDED|90.0|2.3|33.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 6.||33.1|2.3|0.0290
74028167|NCT01380093|147610101|SUPERIORITY_OR_OTHER||LS Mean Difference|49.9|||<|0.0001|TWO_SIDED|95.0|31.8|67.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||67.9|31.8|<0.0001
73921521|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|10.7||0.0988|TWO_SIDED|90.0|-3.8|31.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 8.||31.4|-3.8|0.0988
73921522|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.2|STANDARD_ERROR_OF_MEAN|10.8||0.0549|TWO_SIDED|90.0|-0.5|35.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 10.||35.0|-0.5|0.0549
73921523|NCT01287897|147370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|10.5||0.092|TWO_SIDED|90.0|-3.3|31.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 12.||31.3|-3.3|0.0920
73921524|NCT01287897|147370969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|6.8||0.4031|TWO_SIDED|90.0|-9.5|12.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 2.||12.9|-9.5|0.4031
73921525|NCT01287897|147370969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|9.6||0.1219|TWO_SIDED|90.0|-4.6|26.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 4.||26.8|-4.6|0.1219
73921526|NCT01287897|147370969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|STANDARD_ERROR_OF_MEAN|10.0||0.16|TWO_SIDED|90.0|-6.5|26.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 6.||26.4|-6.5|0.1600
73921527|NCT01287897|147370969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|10.3||0.6019|TWO_SIDED|90.0|-19.5|14.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 8.||14.2|-19.5|0.6019
74028168|NCT01380093|147610102|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.1|||<|0.0001|TWO_SIDED|95.0|-88.5|-31.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-31.6|-88.5|<0.0001
73921528|NCT01287897|147370969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|STANDARD_ERROR_OF_MEAN|12.3||0.1601||90.0|-8.0|32.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 10.||32.5|-8.0|0.1601
73921529|NCT01287897|147370969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|11.7||0.2622|TWO_SIDED|90.0|-11.8|26.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 12.||26.6|-11.8|0.2622
73921530|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|12.22||0.2173|TWO_SIDED|90.0|-29.8|10.6|||Linear mixed model (LMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 2.||10.6|-29.8|0.2173
73921531|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0|STANDARD_ERROR_OF_MEAN|12.95||0.1778|TWO_SIDED|90.0|-33.4|9.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 4.||9.4|-33.4|0.1778
73921532|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|16.37||0.1661|TWO_SIDED|90.0|-43.0|11.2|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 6.||11.2|-43.0|0.1661
73921533|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|17.66||0.1993|TWO_SIDED|90.0|-44.1|14.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 8.||14.3|-44.1|0.1993
73921534|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|19.66||0.0632|TWO_SIDED|90.0|-62.7|2.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 10.||2.3|-62.7|0.0632
73921535|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|19.71||0.1975|TWO_SIDED|90.0|-49.4|15.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 12.||15.8|-49.4|0.1975
73921536|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|12.25||0.5868|TWO_SIDED|90.0|-17.6|22.9|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 2.||22.9|-17.6|0.5868
73921537|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|12.93||0.0243|TWO_SIDED|90.0|-47.0|-4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 4.||-4.3|-47.0|0.0243
73931033|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.37|1.77|||cLDA model||V116/PPSV23|Serotype 10A: V116/PPSV23 GMT Ratio||1.77|1.37|<0.001
74028169|NCT01380093|147610102|SUPERIORITY_OR_OTHER||LS Mean Difference|20.4||||0.1556|TWO_SIDED|95.0|-8.0|48.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||48.7|-8.0|0.1556
73861493|NCT00098722|147268852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.0005|TWO_SIDED|95.0|1.59|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odd ratio \>1 favors maraviroc.||5.23|1.59|0.0005
73967507|NCT05956002|147472245|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|93.24|||||TWO_SIDED|90.0|89.76|96.84|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||96.84|89.76|
74028170|NCT01380093|147610102|SUPERIORITY_OR_OTHER||LS Mean Difference|80.4|||<|0.0001|TWO_SIDED|95.0|52.0|108.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||108.9|52.0|<0.0001
73861494|NCT00098722|147268852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.26|7.92|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.92|2.26|<0.0001
73861495|NCT00098722|147268852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.2|7.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.64|2.20|<0.0001
73861496|NCT00098722|147268854|SUPERIORITY_OR_OTHER||LS mean difference|47.94|STANDARD_ERROR_OF_MEAN|13.383|||TWO_SIDED|95.0|21.64|74.25||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||74.25|21.64|
73861497|NCT00098722|147268854|SUPERIORITY_OR_OTHER||LS mean difference|38.12|STANDARD_ERROR_OF_MEAN|13.313|||TWO_SIDED|95.0|11.96|64.28||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||64.28|11.96|
73861498|NCT00098722|147268854|SUPERIORITY_OR_OTHER||LS mean difference|52.15|STANDARD_ERROR_OF_MEAN|14.803|||TWO_SIDED|95.0|23.06|81.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||81.25|23.06|
73861499|NCT00098722|147268854|SUPERIORITY_OR_OTHER||LS mean difference|58.46|STANDARD_ERROR_OF_MEAN|14.725|||TWO_SIDED|95.0|29.53|87.4||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||87.40|29.53|
73861500|NCT00098722|147268855|SUPERIORITY_OR_OTHER||LS mean difference|218.57|STANDARD_ERROR_OF_MEAN|71.225|||TWO_SIDED|95.0|78.59|358.54||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||358.54|78.59|
73861501|NCT00098722|147268855|SUPERIORITY_OR_OTHER||LS mean difference|133.22|STANDARD_ERROR_OF_MEAN|70.855|||TWO_SIDED|95.0|-6.03|272.47||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||272.47|-6.03|
73861502|NCT00098722|147268855|SUPERIORITY_OR_OTHER||LS mean difference|136.93|STANDARD_ERROR_OF_MEAN|57.85|||TWO_SIDED|95.0|23.24|250.62||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||250.62|23.24|
73861503|NCT00098722|147268855|SUPERIORITY_OR_OTHER||LS mean difference|140.25|STANDARD_ERROR_OF_MEAN|57.55|||TWO_SIDED|95.0|27.15|253.35||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||253.35|27.15|
73861504|NCT00098722|147268856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.29|0.56|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.56|0.29|<0.0001
73861505|NCT00098722|147268856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.23|0.46|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.46|0.23|<0.0001
73861506|NCT00098722|147268857|SUPERIORITY_OR_OTHER||LS mean difference|-0.876|STANDARD_ERROR_OF_MEAN|0.1534|||TWO_SIDED|95.0|-1.177|-0.575||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.575|-1.177|
73861507|NCT00098722|147268857|SUPERIORITY_OR_OTHER||LS mean difference|-0.882|STANDARD_ERROR_OF_MEAN|0.1521|||TWO_SIDED|95.0|-1.181|-0.584||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.584|-1.181|
73861508|NCT00098722|147268857|SUPERIORITY_OR_OTHER||LS mean difference|-0.855|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-1.189|-0.521||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.521|-1.189|
73921538|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.4|STANDARD_ERROR_OF_MEAN|16.12||0.0834|TWO_SIDED|90.0|-49.0|4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 6.||4.3|-49.0|0.0834
73921539|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.8|STANDARD_ERROR_OF_MEAN|17.43||0.0499|TWO_SIDED|90.0|-57.7|0.0|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 8.||-0.0|-57.7|0.0499
73921540|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.9|STANDARD_ERROR_OF_MEAN|19.45||0.0111|TWO_SIDED|90.0|-77.1|-12.7|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 10.||-12.7|-77.1|0.0111
73921541|NCT01287897|147370970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.5|STANDARD_ERROR_OF_MEAN|19.49||0.0221|TWO_SIDED|90.0|-71.7|-7.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 12.||-7.3|-71.7|0.0221
73921542|NCT01287897|147370971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|18.27||0.3157|TWO_SIDED|90.0|-39.0|21.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 2.||21.4|-39.0|0.3157
73921543|NCT01287897|147370971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|18.28||0.4171|TWO_SIDED|90.0|-34.0|26.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 4.||26.4|-34.0|0.4171
73967508|NCT05956002|147472246|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.36|||||TWO_SIDED|90.0|90.97|97.89|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.89|90.97|
73967509|NCT05956002|147472246|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.75|||||TWO_SIDED|90.0|91.41|98.2|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.20|91.41|
74028171|NCT01380093|147610103|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.0||||0.0001|TWO_SIDED|95.0|-124.8|-43.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-43.2|-124.8|0.0001
74028172|NCT01380093|147610103|SUPERIORITY_OR_OTHER||LS Mean Difference|27.4||||0.1826|TWO_SIDED|95.0|-13.3|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||68.1|-13.3|0.1826
74086759|NCT02792218|147727361|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.092|TWO_SIDED|95.0|0.952|1.952|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||1.952|0.952|0.092
73921544|NCT01287897|147370971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|18.79||0.3837|TWO_SIDED|90.0|-36.6|25.5|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 6.||25.5|-36.6|0.3837
73921545|NCT01287897|147370971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|19.27||0.3204|TWO_SIDED|90.0|-40.8|22.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 8.||22.8|-40.8|0.3204
73921546|NCT01287897|147370971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.9|STANDARD_ERROR_OF_MEAN|19.64||0.0649|TWO_SIDED|90.0|-62.3|2.6|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 10.||2.6|-62.3|0.0649
73921547|NCT01287897|147370971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.0|STANDARD_ERROR_OF_MEAN|19.87||0.0598|TWO_SIDED|90.0|-63.9|1.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 12.||1.8|-63.9|0.0598
74028173|NCT01380093|147610103|SUPERIORITY_OR_OTHER||LS Mean Difference|111.4|||<|0.0001|TWO_SIDED|95.0|70.6|152.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||152.2|70.6|<0.0001
74086760|NCT02792218|147727362|SUPERIORITY||Hazard Ratio (HR)|1.186||||0.516|TWO_SIDED|95.0|0.709|1.983|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||1.983|0.709|0.516
74086761|NCT02792218|147727363|SUPERIORITY||rate ratio|0.025|||<|0.001|TWO_SIDED|95.0|0.013|0.049|||negative binomial regression model|||||0.049|0.013|<.001
74086762|NCT02792218|147727364|SUPERIORITY||rate ratio|0.26|||<|0.001|TWO_SIDED|95.0|0.21|0.33|||negative binomial regression model|||Month 12||0.33|0.21|<.001
73861509|NCT00098722|147268857|SUPERIORITY_OR_OTHER||LS mean difference|-1.033|STANDARD_ERROR_OF_MEAN|0.1685|||TWO_SIDED|95.0|-1.364|-0.701||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.701|-1.364|
73861510|NCT02351349|147268867|OTHER|paired t test pre compared to post readings||||||0.0143|||||||t-test, 2 sided|||||||0.0143
73861511|NCT02351349|147268868|OTHER|as above||||||0.1416|||||||t-test, 2 sided|||pre and post comparison of time up and go in intervention group||||0.1416
73861512|NCT02351349|147268869|OTHER|||||||0.9013|||||||t-test, 2 sided|||pre and post value comparison with paired t test was carried out||||0.9013
73921548|NCT00065507|147370976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.18|||Regression, Linear|Linear regression model adjusted for baseline HBV DNA and LVDr status.||||-1.18|-2.30|<0.0001
73921549|NCT00065507|147370977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.85|-0.96|||Regression, Linear|adjusted for baseline HBV DNA and LVDr Status||||-0.96|-1.85|<0.0001
73921550|NCT00065507|147370978|SUPERIORITY_OR_OTHER||Mean Percent Difference|32.7|||<|0.0001|TWO_SIDED|95.0|20.2|45.2|||Cochran-Mantel-Haenszel|||||45.2|20.2|<0.0001
73921551|NCT00065507|147370979|SUPERIORITY_OR_OTHER||Mean percent treatment difference|38.0|||<|0.0001|TWO_SIDED|95.0|24.8|50.3|||Cochran-Mantel-Haenszel|||||50.3|24.8|<0.0001
73921552|NCT00065507|147370980|SUPERIORITY_OR_OTHER||percent treatment difference|19.2||||0.0193|TWO_SIDED|95.0|3.7|34.6|||Cochran-Mantel-Haenszel|||Week 24 treatment difference||34.6|3.7|0.0193
73921553|NCT00065507|147370980|SUPERIORITY_OR_OTHER||percent treatment difference|16.4||||0.0425|TWO_SIDED|95.0|0.9|32.0|||Cochran-Mantel-Haenszel|||Week 48 treatment difference||32.0|0.9|0.0425
73921554|NCT00065507|147370986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.51|TWO_SIDED|95.0|-1.63|0.82|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 24||0.82|-1.63|0.51
73861513|NCT01610596|147268875|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73861514|NCT01519674|147268879|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.24||||0.011||95.0|0.06|0.43||No corrections for multiplicity were performed.|Regression, Linear|||"The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by:~H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Met and BID+Sita+Met)."||0.43|0.06|0.011
73921555|NCT00065507|147370986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|||<|0.0001|TWO_SIDED|95.0|-1.08|1.88|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 48||1.88|-1.08|<0.0001
73921556|NCT00065507|147370994|SUPERIORITY_OR_OTHER||Difference Estimate|10.4|||||TWO_SIDED|95.0|-4.5|25.2||||||Difference estimate ETV - ADV at Week 48||25.2|-4.5|
73921557|NCT00065507|147370995|SUPERIORITY_OR_OTHER||Difference Estimate|-0.4|||||TWO_SIDED|95.0|-8.7|8.0||||||Difference Estimate at Week 48||8.0|-8.7|
73921558|NCT00065507|147370996|SUPERIORITY_OR_OTHER||Difference Estimate|-7.2|||||TWO_SIDED|95.0|-21.3|6.9||||||Difference Estimate at Week 48||6.9|-21.3|
73921559|NCT00065507|147370997|SUPERIORITY_OR_OTHER||Difference Estimate|5.7|||||TWO_SIDED|95.0|-0.3|11.7||||||Difference Estimate at Week 48||11.7|-0.3|
73921560|NCT00065507|147370998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2|TWO_SIDED|95.0|0.46|1.18|||Regression, Cox|Cox proportional hazard model, adjusted for age \<=45 versus age \>45 years, gender, and race (white versus non-white).||treatment comparison of HCC-free survival at Week 48||1.18|0.46|0.20
73921561|NCT00227903|147371017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0||||Not corrected for multiple comparison|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power||||0.88
73921562|NCT00227903|147371018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0|||||Fisher Exact|||||||0.08
73921563|NCT00227903|147371019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0||||Not corrected for multiple comparison.|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power.||||0.88
73921564|NCT00227903|147371020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||95.0|||||Fisher Exact|||||||0.41
73921565|NCT00227903|147371021|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77||||0.79|TWO_SIDED|95.0|0.36|1.67|||Regression, Logistic|||||1.67|0.36|0.79
73921566|NCT00227903|147371022|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.79|TWO_SIDED|95.0|0.42|2.62|||Regression, Logistic|||||2.62|0.42|0.79
73921567|NCT00227903|147371023|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.88|TWO_SIDED|95.0|0.34|2.72|||Regression, Logistic|||||2.72|0.34|0.88
73921568|NCT00227903|147371024|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.88|TWO_SIDED|95.0|0.57|2.57|||Regression, Logistic|||||2.57|0.57|0.88
73861515|NCT01519674|147268879|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.11||||0.231||95.0|-0.3|0.07|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).||0.07|-0.30|0.231
73861516|NCT01519674|147268879|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.36|||<|0.001||95.0|-0.54|-0.17|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).||-0.17|-0.54|<0.001
73861517|NCT01519674|147268880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.022||95.0|0.39|0.93|||Regression, Logistic|||||0.93|0.39|0.022
73861518|NCT01519674|147268880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.618||95.0|0.73|1.71|||Regression, Logistic|||||1.71|0.73|0.618
73861519|NCT01519674|147268880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.005||95.0|1.2|2.85|||Regression, Logistic|||||2.85|1.20|0.005
73861520|NCT01519674|147268881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.02||95.0|0.38|0.92|||Regression, Logistic|||||0.92|0.38|0.020
73921569|NCT00227903|147371025|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77||||0.5|TWO_SIDED|95.0|0.32|1.84|||Regression, Logistic|||||1.84|0.32|0.50
73921570|NCT00227903|147371026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
73921571|NCT00227903|147371027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
73921572|NCT00227903|147371028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
73921573|NCT00227903|147371029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
73921574|NCT00227903|147371030|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.5|TWO_SIDED|95.0|0.27|2.11|||Regression, Logistic|||||2.11|0.27|0.50
73921575|NCT00227903|147371031|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.07|TWO_SIDED|95.0|0.44|3.14|||Regression, Logistic|||||3.14|0.44|0.07
73921576|NCT00227903|147371032|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.07|TWO_SIDED|95.0|0.47|4.52|||Regression, Logistic|||||4.52|0.47|0.07
73921577|NCT00227903|147371033|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.07|TWO_SIDED|95.0|0.08|1.02|||Regression, Logistic|||||1.02|0.08|0.07
73921578|NCT00227903|147371034|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.62||||0.07|TWO_SIDED|95.0|0.1|3.9|||Regression, Logistic|||||3.90|0.10|0.07
73921579|NCT00227903|147371035|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.91|TWO_SIDED|95.0|0.32|4.2|||Regression, Logistic|||||4.20|0.32|0.91
73921580|NCT00227903|147371036|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.91|TWO_SIDED|95.0|0.35|5.07|||Regression, Logistic|||||5.07|0.35|0.91
73921581|NCT00227903|147371037|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.85||||0.91|TWO_SIDED|95.0|0.14|5.23|||Regression, Logistic|||||5.23|0.14|0.91
73921582|NCT00227903|147371038|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.91|TWO_SIDED|95.0|0.21|7.12|||Regression, Logistic|||||7.12|0.21|0.91
73921583|NCT00227903|147371039|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.04|TWO_SIDED|95.0|0.46|3.55|||Regression, Logistic|||||3.55|0.46|.04
73921584|NCT00227903|147371040|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.04|TWO_SIDED|95.0|0.35|4.17|||Regression, Logistic|||||4.17|0.35|0.04
73921585|NCT00227903|147371041|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.25||||0.04|TWO_SIDED|95.0|0.04|1.63|||Regression, Logistic|||||1.63|0.04|0.04
73921586|NCT00227903|147371042|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.04|TWO_SIDED|95.0|0.04|3.74|||Regression, Logistic|||||3.74|0.04|0.04
73921587|NCT00227903|147371043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||||||0.01
73921588|NCT00227903|147371044|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
73921589|NCT01172847|147371051|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.91|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir||1.05|0.91|
73921590|NCT01172847|147371051|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.95|1.02|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate||1.02|0.95|
73921591|NCT01172847|147371052|SUPERIORITY_OR_OTHER||mean exposure ratio|1.03|||||TWO_SIDED|90.0|1.0|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of rimantadine||1.06|1.00|
73921592|NCT01172847|147371053|SUPERIORITY_OR_OTHER||mean exposure ratio|0.86|||||TWO_SIDED|90.0|0.77|0.96|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir||0.96|0.77|
73921593|NCT01172847|147371053|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate||1.05|0.92|
73921594|NCT01172847|147371054|SUPERIORITY_OR_OTHER||mean exposure ratio|1.03|||||TWO_SIDED|90.0|0.99|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|mean exposure ratio of rimantadine||1.06|0.99|
73921595|NCT01163279|147371059|SUPERIORITY_OR_OTHER|||||||0.03||||||Statistical analysis applies to post intervention performance category|Chi-squared|||||||0.03
73921596|NCT01163279|147371059|SUPERIORITY_OR_OTHER|||||||0.32||||||Statistical analysis applies to post intervention satisfaction category|Chi-squared|||||||0.32
73921597|NCT01163279|147371059|SUPERIORITY_OR_OTHER|||||||0.54||||||Statistical analysis applies to 3-month follow up performance category|Chi-squared|||||||0.54
73921598|NCT01163279|147371059|SUPERIORITY_OR_OTHER|||||||0.26||||||Statistical analysis applies to 3-month follow up satisfaction category|Chi-squared|||||||0.26
73921599|NCT01163279|147371060|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
73921600|NCT01163279|147371061|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
73921601|NCT01163279|147371062|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
73921602|NCT01163279|147371063|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
73921603|NCT01163279|147371064|SUPERIORITY_OR_OTHER||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.1
73921604|NCT01163279|147371064|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
73921605|NCT01163279|147371065|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.05
73921606|NCT01163279|147371065|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||>0.05
73921607|NCT01163279|147371066|SUPERIORITY_OR_OTHER||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.1
73921608|NCT01163279|147371066|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
73921609|NCT01163279|147371067|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
73921610|NCT01163279|147371068|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||>0.05
73921611|NCT01163279|147371068|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
73921612|NCT01163279|147371069|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
73921613|NCT02632552|147371101|EQUIVALENCE|Using a pre-intervention rate of 18 for both intervention and control, and a post-control change of 1, assuming an alpha of 0.05, we have power (0.8) to detect a difference of differences in change in mean urgent care/ED utilization of 0.75 with a standard deviation equal to the control mean; however, the equivalence boundary did not apply because this is a pragmatic trial.|Incidence Rate Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.15||0.45|TWO_SIDED|95.0|0.85|1.45|||Mixed Effects Negative Binomial Model|A segmented negative binomial regression model was used to estimate changes in ED/urgent care utilization between the intervention and control groups.||||1.45|0.85|0.45
73921614|NCT02632552|147371102|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-1.8||||0.05|TWO_SIDED|95.0|-7.21|3.61|||Mixed Models Analysis|||||3.61|-7.21|0.05
73921615|NCT02632552|147371103|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.38||0.03|TWO_SIDED|95.0|0.08|1.57|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||1.57|0.08|0.03
73921616|NCT02632552|147371104|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.75|TWO_SIDED|95.0|-0.41|0.29|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||0.29|-0.41|0.75
73921617|NCT02632552|147371105|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.74|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||0.70|-0.50|0.74
73921618|NCT02632552|147371106|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.87||0.63|TWO_SIDED|95.0|-2.21|1.29|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||1.29|-2.21|0.63
73921619|NCT02632552|147371107|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta of Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|1.26||0.23|TWO_SIDED|95.0|-0.97|4.05|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||4.05|-0.97|0.23
73921620|NCT02632552|147371108|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|2.8||0.38|TWO_SIDED|95.0|-7.95|3.1||MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.|Mixed Models Analysis|||||3.10|-7.95|0.38
73921621|NCT02632552|147371109|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-2.79|STANDARD_ERROR_OF_MEAN|3.2||0.38|TWO_SIDED|95.0|-9.1|3.52|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||3.52|-9.10|0.38
73921622|NCT02574247|147371131|OTHER|||||||0.34|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -9 dB SNR||||0.34
73921623|NCT02574247|147371131|OTHER|||||||0.64|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -6 dB SNR||||0.64
73921624|NCT02574247|147371131|OTHER|||||||0.24|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -6 dB SNR||||0.24
73921625|NCT02574247|147371131|OTHER|||||||0.2|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -3 dB SNR||||0.20
73921626|NCT02574247|147371134|OTHER|||||||0.03|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM slope||||0.03
73861521|NCT01519674|147268881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.286||95.0|0.81|2.07|||Regression, Logistic|||||2.07|0.81|0.286
73921627|NCT02574247|147371134|OTHER|||||||0.04|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for row IEEE slope||||0.04
73921628|NCT05167734|147371189|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.02|TWO_SIDED|95.0|0.1|1.2|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|values greater than 0 infer higher hemoglobin in active intervention|||1.2|0.1|0.02
73921629|NCT05167734|147371190|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.04|TWO_SIDED|95.0|0.0|1.1|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|adjusted mean difference|3-months post hospitalization||1.1|0.0|0.04
73921630|NCT05167734|147371190|SUPERIORITY||Mean Difference (Net)|0.2||||0.42|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission||Hospital Discharge||0.7|-0.3|0.42
73921631|NCT05167734|147371191|SUPERIORITY|||||||0.352|||||||Mixed Models Analysis|||||||0.352
73921632|NCT05167734|147371192|SUPERIORITY||||||<|0.001||||||threshold for significance - p\<0.05|Mixed Models Analysis|||||||<0.001
73921633|NCT05167734|147371193|SUPERIORITY||Odds Ratio (OR)|1.03||||0.94|TWO_SIDED|95.0|0.44|2.4|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|Hospital Discharge||2.40|0.44|0.94
73967510|NCT05956002|147472246|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|85.44|||||TWO_SIDED|90.0|82.43|88.55|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||88.55|82.43|
73967511|NCT05956002|147472246|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|93.28|||||TWO_SIDED|90.0|89.61|97.1|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.10|89.61|
73967512|NCT05956002|147472247|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.7|||||TWO_SIDED|90.0|90.38|99.22|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||99.22|90.38|
74086763|NCT02792218|147727364|SUPERIORITY||rate ratio|0.22|||<|0.001|TWO_SIDED|95.0|0.15|0.34|||negative binomial regression model|||Month 24||0.34|0.15|<.001
73861522|NCT01519674|147268881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2|||<|0.001||95.0|1.39|3.47|||Regression, Logistic|||||3.47|1.39|<0.001
73861523|NCT01519674|147268882|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.13||||0.52||95.0|-0.26|0.52|||Regression, Linear|||||0.52|-0.26|0.520
73861524|NCT01519674|147268882|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.05||||0.788||95.0|-0.34|0.45|||Regression, Linear|||||0.45|-0.34|0.788
73921634|NCT05167734|147371193|SUPERIORITY||Odds Ratio (OR)|1.79||||0.18|TWO_SIDED|95.0|0.76|4.2|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||4.20|0.76|0.18
73921635|NCT05167734|147371193|SUPERIORITY||Odds Ratio (OR)|1.23||||0.64|TWO_SIDED|95.0|0.51|3.0|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||3.00|0.51|0.64
73921636|NCT05167734|147371194|SUPERIORITY||Odds Ratio (OR)|1.81||||0.23|TWO_SIDED|95.0|0.68|4.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|Hospital discharge||4.80|0.68|0.23
73921637|NCT05167734|147371194|SUPERIORITY||Odds Ratio (OR)|2.43||||0.09|TWO_SIDED|95.0|0.87|6.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||6.80|0.87|0.09
73921638|NCT05167734|147371194|SUPERIORITY||Odds Ratio (OR)|2.52||||0.084|TWO_SIDED|95.0|0.88|7.2|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||7.20|0.88|0.084
73861525|NCT01519674|147268882|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.07||||0.708||95.0|-0.46|0.31|||Regression, Linear|||||0.31|-0.46|0.708
73861526|NCT01519674|147268883|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.28||||0.291||95.0|-0.24|0.81|||Regression, Linear|||||0.81|-0.24|0.291
73861527|NCT01519674|147268883|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.88||||0.001||95.0|-1.41|-0.35|||Regression, Linear|||||-0.35|-1.41|0.001
73861528|NCT01519674|147268883|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.16|||<|0.001||95.0|-1.69|-0.64|||Regression, Linear|||||-0.64|-1.69|<0.001
73861529|NCT01519674|147268884|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.85||||0.005||95.0|0.26|1.45|||Regression, Linear|||||1.45|0.26|0.005
73967513|NCT05956002|147472247|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|92.72|||||TWO_SIDED|90.0|88.59|97.04|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.04|88.59|
73967514|NCT05956002|147472247|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|87.24|||||TWO_SIDED|90.0|83.35|91.31|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||91.31|83.35|
74028174|NCT01380093|147610104|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.7|||<|0.0001|TWO_SIDED|95.0|-16.4|-7.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-7.0|-16.4|<0.0001
74028175|NCT01380093|147610104|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.0811|TWO_SIDED|95.0|-0.5|8.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.9|-0.5|0.0811
74028176|NCT01380093|147610104|SUPERIORITY_OR_OTHER||LS Mean Difference|15.9|||<|0.0001|TWO_SIDED|95.0|11.1|20.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||20.6|11.1|<0.0001
74028177|NCT01380093|147610105|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5||||0.0007|TWO_SIDED|95.0|-3.8|-1.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.1|-3.8|0.0007
74028178|NCT01380093|147610105|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.1631|TWO_SIDED|95.0|-0.4|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.3|-0.4|0.1631
73967515|NCT05956002|147472247|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|92.59|||||TWO_SIDED|90.0|88.24|97.17|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.17|88.24|
73967516|NCT03940963|147472258|NON_INFERIORITY|The visual analog scale (VAS, 0-100 scale) pain score change from baseline value to 12 months was tested for non-inferiority of neurectomy with Axoguard Nerve Cap to standard neurectomy alone using closed testing procedures.||||||0.011||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.011
73967517|NCT03940963|147472261|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.485||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.485
73967518|NCT03940963|147472262|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.259||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.259
73967519|NCT03940963|147472263|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.14||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.140
73967520|NCT03940963|147472264|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.544||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.544
74028179|NCT01380093|147610105|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|||<|0.0001|TWO_SIDED|95.0|2.1|4.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.8|2.1|<0.0001
74028180|NCT01380093|147610106|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2||||0.2117|TWO_SIDED|95.0|-3.1|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.7|-3.1|0.2117
74028181|NCT01380093|147610106|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.0345|TWO_SIDED|95.0|0.2|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.0|0.2|0.0345
74028182|NCT01380093|147610106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0011|TWO_SIDED|95.0|1.4|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.2|1.4|0.0011
74028183|NCT01380093|147610107|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.2||||0.0002|TWO_SIDED|95.0|-18.4|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-6.0|-18.4|0.0002
74086764|NCT02792218|147727364|SUPERIORITY||rate ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.15|0.22|||negative binomial regression model|||End of Study||0.22|0.15|<.001
74086765|NCT02792218|147727365|SUPERIORITY||Geo-mean ratio|0.93||||0.011|TWO_SIDED|95.0|0.89|0.98|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 3||0.98|0.89|0.011
74086766|NCT02792218|147727365|SUPERIORITY||Geo-mean ratio|0.73|||<|0.001|TWO_SIDED|95.0|0.69|0.77|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 12||0.77|0.69|<.001
74086767|NCT02792218|147727365|SUPERIORITY||Geo-mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.72|0.82|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 24||0.82|0.72|<.001
73861530|NCT01519674|147268884|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.52||||0.085||95.0|-0.07|1.12|||Regression, Linear|||||1.12|-0.07|0.085
73967521|NCT03940963|147472266|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.049||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.049
73967522|NCT01787383|147472371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.13
73967523|NCT01787383|147472372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|TWO_SIDED||||||Regression, Logistic|||||||0.34
73861531|NCT01519674|147268884|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.33||||0.275||95.0|-0.92|0.26|||Regression, Linear|||||0.26|-0.92|0.275
73861532|NCT01519674|147268885|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.12||||0.674||95.0|-0.7|0.45|||Regression, Linear|||||0.45|-0.70|0.674
73861533|NCT01519674|147268885|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.72||||0.015||95.0|0.14|1.3|||Regression, Linear|||||1.30|0.14|0.015
73861534|NCT01519674|147268885|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.84||||0.004||95.0|0.27|1.41|||Regression, Linear|||||1.41|0.27|0.004
73861535|NCT01519674|147268886|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.31||||0.08||95.0|-0.04|0.65|||Regression, Linear|||||0.65|-0.04|0.080
73861536|NCT01519674|147268886|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.09||||0.613||95.0|-0.26|0.43|||Regression, Linear|||||0.43|-0.26|0.613
73861537|NCT01519674|147268886|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.22||||0.213||95.0|-0.56|0.13|||Regression, Linear|||||0.13|-0.56|0.213
73861538|NCT01519674|147268889|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.29||||0.8||95.0|-1.97|2.56|||Regression, Linear|||||2.56|-1.97|0.800
73861539|NCT01519674|147268889|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.02||||0.989||95.0|-2.26|2.29|||Regression, Linear|||||2.29|-2.26|0.989
73861540|NCT01519674|147268889|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.28||||0.809||95.0|-2.52|1.97|||Regression, Linear|||||1.97|-2.52|0.809
73861541|NCT02317809|147268898|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|114.45|||||TWO_SIDED|90.0|110.87|118.15|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||118.15|110.87|
73861542|NCT02317809|147268899|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|106.99|||||TWO_SIDED|90.0|101.42|112.86|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||112.86|101.42|
73861543|NCT02317809|147268900|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|112.67|||||TWO_SIDED|90.0|106.44|119.27|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||119.27|106.44|
73861544|NCT02317809|147268901|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|103.27|||||TWO_SIDED|90.0|93.16|114.47|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||114.47|93.16|
73861545|NCT03523273|147268942|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73861546|NCT03523273|147268943|SUPERIORITY|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
73861547|NCT02590562|147268993|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||F test|||||||<0.0001
73861548|NCT02590562|147268994|SUPERIORITY_OR_OTHER|||||||0.0108|TWO_SIDED||||||F test|||||||0.0108
73861549|NCT03180398|147269000|SUPERIORITY|It was hoped to compare radiomics features, using non-parametric tests, but this was not possible because of the small number of patients accrued.|||||||||||||||||Not enough patients were accrued for radiomics analysis. PI left institution and country. Analysis could not be completed.|||
73861550|NCT03180398|147269001|OTHER|Analysis could not be completed.|||||||||||||||||PI left institution and country. Analysis could not be completed.|||
73861551|NCT00598078|147269006|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANOVA|||||||0.013
73861552|NCT00598078|147269006|SUPERIORITY_OR_OTHER|||||||0.713||95.0|||||ANOVA|||||||0.713
73861553|NCT00598078|147269006|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANOVA|||||||0.038
73861554|NCT02699450|147269015|SUPERIORITY||Difference in Least Squares Means|1.4||||0.37|TWO_SIDED|80.0|-0.6|3.4||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.4|-0.6|0.37
73861555|NCT02699450|147269015|SUPERIORITY||Difference in Least Squares Means|3.6||||0.03|TWO_SIDED|80.0|1.5|5.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||5.6|1.5|0.03
73861556|NCT02699450|147269016|SUPERIORITY||Difference in Least Squares Means|1.3||||0.63|TWO_SIDED|80.0|-2.3|5.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||5.0|-2.3|0.63
73967524|NCT01787383|147472373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|TWO_SIDED||||||Regression, Logistic|||||||0.088
73967525|NCT01787383|147472374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.20
73967526|NCT01787383|147472375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.38
73967527|NCT01787383|147472376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.033
73967528|NCT01787383|147472377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.37
73967529|NCT01787383|147472378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.66
73967530|NCT04533347|147472379|SUPERIORITY|||||||0.1879|TWO_SIDED|95.0|||||Fisher Exact|||Assuming an 85% clinical recovery rate in the TQ group and a 70% clinical recovery rate in the placebo group, sample sizes of 125 per treatment group were expected to achieve 80% power with a two-sided alpha of 0.05.||||0.1879
73967531|NCT03562377|147472415|NON_INFERIORITY|The difference in response rates was calculated using the Mantel-Haenszel estimate of the risk difference stratified by baseline disease severity together with the 2-sided 95% CI. Non-inferiority of tralokinumab was demonstrated if the lower limit of the 95% CI was greater than -25%. Power calculation assumed 160 subjects in the per protocol analysis set, providing 98% power to establish non-inferiority, assuming response rates of 80% in both treatment groups and a non-inferiority margin of -25%|Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-11.3|3.1|||Mantel Haenszel|||||3.1|-11.3|
74086768|NCT02792218|147727366|SUPERIORITY||Mean Difference (Net)|0.07||||0.118|TWO_SIDED|95.0|-0.02|0.15|||random coefficient model|||||0.15|-0.02|0.118
74086769|NCT02792218|147727369|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.002|TWO_SIDED|95.0|0.486|0.847|||Regression, Cox|||||0.847|0.486|0.002
74086770|NCT02792218|147727370|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.008|TWO_SIDED|95.0|0.481|0.898|||Regression, Cox|||||0.898|0.481|0.008
73861557|NCT02699450|147269017|SUPERIORITY||Difference in Least Squares Means|2.3||||0.15|TWO_SIDED|80.0|0.2|4.3||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.3|0.2|0.15
73921639|NCT05167734|147371195|SUPERIORITY||Mean Difference (Net)|218.0||||0.13|TWO_SIDED|95.0|-73.0|510.0|||Mixed Models Analysis|adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, and baseline ADLs|scores greater than 0 reflect greater ambulatory distance in active intervention|1-month post hospitalization||510|-73|0.13
73921640|NCT05167734|147371195|SUPERIORITY||Median Difference (Net)|178.0||||0.27|TWO_SIDED|95.0|-154.0|510.0|||Mixed Models Analysis|adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, baseline ADLs||3-months post hospitalization||510|-154|0.27
73921641|NCT05167734|147371196|SUPERIORITY||Odds Ratio (OR)|2.49||||0.12|TWO_SIDED|95.0|0.79|7.8|||proportional odds|adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||7.80|0.79|0.12
73921642|NCT05167734|147371196|SUPERIORITY||Odds Ratio (OR)|3.1||||0.07|TWO_SIDED|95.0|0.91|10.5|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||10.5|0.91|0.07
73921643|NCT05167734|147371197|SUPERIORITY||Odds Ratio (OR)|0.5||||0.29|TWO_SIDED|95.0|0.14|1.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization for anxiety score||1.80|0.14|0.29
73921644|NCT05167734|147371197|SUPERIORITY||Odds Ratio (OR)|0.68||||0.57|TWO_SIDED|95.0|0.18|2.6|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization for anxiety score||2.60|0.18|0.57
73921645|NCT05167734|147371197|SUPERIORITY||Odds Ratio (OR)|0.36||||0.12|TWO_SIDED|95.0|0.1|1.3|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization for depression score||1.30|0.10|0.12
73921646|NCT05167734|147371197|SUPERIORITY||Odds Ratio (OR)|0.62||||0.48|TWO_SIDED|95.0|0.16|2.4|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization for depression score||2.40|0.16|0.48
73921647|NCT05167734|147371198|SUPERIORITY||Odds Ratio (OR)|1.48||||0.56|TWO_SIDED|95.0|0.39|5.6|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||5.60|0.39|0.56
73921648|NCT05167734|147371198|SUPERIORITY||Odds Ratio (OR)|9.16||||0.02|TWO_SIDED|95.0|1.4|59.9|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||59.9|1.40|0.02
73921649|NCT05167734|147371199|SUPERIORITY||Odds Ratio (OR)|0.16||||0.09|TWO_SIDED|95.0|0.02|1.4|||Regression, Logistic|adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|||1.40|0.02|0.09
73921650|NCT05167734|147371201|SUPERIORITY||Odds Ratio (OR)|0.73||||0.48|TWO_SIDED|95.0|0.3|1.8|||Regression, Logistic|logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention|3-months post hospitalization||1.80|0.30|0.48
73921651|NCT05167734|147371202|SUPERIORITY||Odds Ratio (OR)|2.13||||0.54|TWO_SIDED|95.0|0.19|24.0|||Regression, Logistic|logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention|3-months post hospitalization||24.0|0.19|0.54
73921652|NCT02604212|147371208|SUPERIORITY||LS Mean Difference|-0.042|STANDARD_ERROR_OF_MEAN|0.102||0.6815|TWO_SIDED|95.0|-0.243|0.159|||MMRM|||||0.159|-0.243|0.6815
73921653|NCT02604212|147371208|SUPERIORITY||LS Mean Difference|-0.438|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.638|-0.237|||MMRM|||||-0.237|-0.638|<.0001
73921654|NCT02604212|147371208|SUPERIORITY||LS Mean Difference|-0.396|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.569|-0.223|||MMRM|||||-0.223|-0.569|<.0001
73921655|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.208|STANDARD_ERROR_OF_MEAN|0.083||0.0131|TWO_SIDED|95.0|-0.372|-0.044|||MMRM|||Day 15||-0.044|-0.372|0.0131
73921656|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.247|STANDARD_ERROR_OF_MEAN|0.084||0.0036|TWO_SIDED|95.0|-0.412|-0.082|||MMRM|||Day 15||-0.082|-0.412|0.0036
73921657|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.039|STANDARD_ERROR_OF_MEAN|0.077||0.6136|TWO_SIDED|95.0|-0.192|0.113|||MMRM|||Day 15||0.113|-0.192|0.6136
73921658|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.085|STANDARD_ERROR_OF_MEAN|0.083||0.3104|TWO_SIDED|95.0|-0.249|0.08|||MMRM|||Day 29||0.080|-0.249|0.3104
73967532|NCT03562377|147472416|NON_INFERIORITY|The difference in response rates was calculated using the Mantel-Haenszel estimate of the risk difference stratified by baseline disease severity together with the 2-sided 95% CI. Non-inferiority of tralokinumab was demonstrated if the lower limit of the 95% CI was greater than -25%. Power calculation assumed 160 subjects in the per protocol analysis set, providing 98% power to establish non-inferiority, assuming response rates of 80% in both treatment groups and a non-inferiority margin of -25%|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-9.2|12.8|||Mantel Haenszel|||||12.8|-9.2|
73967533|NCT03562377|147472417|SUPERIORITY||Risk Difference (RD)|11.4||||0.049|TWO_SIDED|95.0|0.2|22.6||The p-value was adjusted for multiplicity by a pre-specified testing hierarchy. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.|Cochran-Mantel-Haenszel|The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by baseline disease severity (moderate or severe).||||22.6|0.2|0.049
73921659|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.174|STANDARD_ERROR_OF_MEAN|0.084||0.0401|TWO_SIDED|95.0|-0.34|-0.008|||MMRM|||Day 29||-0.008|-0.340|0.0401
73921660|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.077||0.2494|TWO_SIDED|95.0|-0.242|0.063|||MMRM|||Day 29||0.063|-0.242|0.2494
73921661|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.211|STANDARD_ERROR_OF_MEAN|0.085||0.0149|TWO_SIDED|95.0|-0.38|-0.042|||MMRM|||Day 43||-0.042|-0.380|0.0149
73921662|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.319|STANDARD_ERROR_OF_MEAN|0.086||0.0003|TWO_SIDED|95.0|-0.489|-0.149|||MMRM|||Day 43||-0.149|-0.489|0.0003
73921663|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.108|STANDARD_ERROR_OF_MEAN|0.078||0.1655|TWO_SIDED|95.0|-0.262|0.045|||MMRM|||Day 29||0.045|-0.262|0.1655
73921664|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.088||0.0889|TWO_SIDED|95.0|-0.324|0.023|||MMRM|||Day 57||0.023|-0.324|0.0889
73921665|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.322|STANDARD_ERROR_OF_MEAN|0.088||0.0004|TWO_SIDED|95.0|-0.497|-0.147|||MMRM|||Day 57||-0.147|-0.497|0.0004
73921666|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.172|STANDARD_ERROR_OF_MEAN|0.078||0.0298|TWO_SIDED|95.0|-0.326|-0.017|||MMRM|||Day 57||-0.017|-0.326|0.0298
73921667|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.184|STANDARD_ERROR_OF_MEAN|0.089||0.0415|TWO_SIDED|95.0|-0.361|-0.007|||MMRM|||Day 71||-0.007|-0.361|0.0415
73921668|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.441|STANDARD_ERROR_OF_MEAN|0.091|<|0.0001|TWO_SIDED|95.0|-0.62|-0.261|||MMRM|||Day 71||-0.261|-0.620|<.0001
74028184|NCT01380093|147610107|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4||||0.0081|TWO_SIDED|95.0|2.3|14.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||14.6|2.3|0.0081
73921669|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.257|STANDARD_ERROR_OF_MEAN|0.079||0.0015|TWO_SIDED|95.0|-0.413|-0.1|||MMRM|||Day 71||-0.100|-0.413|0.0015
73921670|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.086|STANDARD_ERROR_OF_MEAN|0.092||0.351|TWO_SIDED|95.0|-0.268|0.096|||MMRM|||Day 85||0.096|-0.268|0.3510
73921671|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.404|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.59|-0.219|||MMRM|||Day 85||-0.219|-0.590|<.0001
73921672|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.318|STANDARD_ERROR_OF_MEAN|0.082||0.0002|TWO_SIDED|95.0|-0.481|-0.156|||MMRM|||Day 85||-0.156|-0.481|0.0002
73921673|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.151|STANDARD_ERROR_OF_MEAN|0.096||0.1198|TWO_SIDED|95.0|-0.341|0.04|||MMRM|||Day 99||0.040|-0.341|0.1198
73921674|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.516|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.708|-0.325|||MMRM|||Day 99||-0.325|-0.708|<.0001
73921675|NCT02604212|147371209|SUPERIORITY||LS Mean Difference|-0.366|STANDARD_ERROR_OF_MEAN|0.085|<|0.0001|TWO_SIDED|95.0|-0.535|-0.197|||MMRM|||Day 99||-0.197|-0.535|<.0001
73921676|NCT02604212|147371210|SUPERIORITY|||||||0.0867|||||||Fisher Exact|||||||0.0867
73921677|NCT02604212|147371210|SUPERIORITY|||||||0.6285|||||||Fisher Exact|||||||0.6285
73921678|NCT02604212|147371210|SUPERIORITY|||||||0.7214|||||||Fisher Exact|||||||0.7214
73921679|NCT02604212|147371211|SUPERIORITY|||||||0.0325|||||||Fisher Exact|||||||0.0325
73921680|NCT02604212|147371211|SUPERIORITY|||||||0.1409|||||||Fisher Exact|||||||0.1409
73861558|NCT02699450|147269017|SUPERIORITY||Difference in Least Squares Means|2.9||||0.04|TWO_SIDED|80.0|1.1|4.7||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.7|1.1|0.04
73861559|NCT02699450|147269018|SUPERIORITY||Difference in Least Squares Means|0.8||||0.94|TWO_SIDED|80.0|-11.3|12.8||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||12.8|-11.3|0.94
73861560|NCT02699450|147269018|SUPERIORITY||Difference in Least Squares Means|7.3||||0.46|TWO_SIDED|80.0|-5.4|19.9||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||19.9|-5.4|0.46
73921681|NCT02604212|147371211|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
73861561|NCT02699450|147269019|SUPERIORITY||Difference in Percentage of Participants|6.4||||0.56|TWO_SIDED|80.0|-7.7|20.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||20.5|-7.7|0.56
73921682|NCT02604212|147371212|SUPERIORITY|||||||0.0824|||||||Fisher Exact|||||||0.0824
73921683|NCT02604212|147371212|SUPERIORITY|||||||0.2217|||||||Fisher Exact|||||||0.2217
73921684|NCT02604212|147371212|SUPERIORITY|||||||0.1409|||||||Fisher Exact|||||||0.1409
73921685|NCT02604212|147371213|SUPERIORITY|||||||0.0625|||||||Fisher Exact|||||||0.0625
73921686|NCT02604212|147371213|SUPERIORITY|||||||0.0684|||||||Fisher Exact|||||||0.0684
73921687|NCT02604212|147371213|SUPERIORITY|||||||0.2105|||||||Fisher Exact|||||||0.2105
73921688|NCT02604212|147371214|SUPERIORITY|||||||0.175|||||||Fisher Exact|||||||0.1750
73921689|NCT02604212|147371214|SUPERIORITY|||||||0.0229|||||||Fisher Exact|||||||0.0229
73921690|NCT02604212|147371214|SUPERIORITY|||||||0.0294|||||||Fisher Exact|||||||0.0294
73921691|NCT02604212|147371215|SUPERIORITY|||||||0.4615|||||||Fisher Exact|||||||0.4615
73921692|NCT02604212|147371215|SUPERIORITY|||||||0.0508|||||||Fisher Exact|||||||0.0508
73921693|NCT02604212|147371215|SUPERIORITY|||||||0.0769|||||||Fisher Exact|||||||0.0769
73921694|NCT02604212|147371216|SUPERIORITY|||||||0.0699|||||||Fisher Exact|||||||0.0699
73921695|NCT02604212|147371216|SUPERIORITY|||||||0.0179|||||||Fisher Exact|||||||0.0179
73921696|NCT02604212|147371216|SUPERIORITY|||||||0.043|||||||Fisher Exact|||||||0.0430
73921697|NCT02604212|147371217|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
73921698|NCT02604212|147371217|SUPERIORITY|||||||0.0849|||||||Fisher Exact|||||||0.0849
73921699|NCT02604212|147371217|SUPERIORITY|||||||0.0849|||||||Fisher Exact|||||||0.0849
73921700|NCT01119131|147371227|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED||||||ANOVA|||||||0.699
73921701|NCT01119131|147371228|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||ANOVA|||||||0.308
73921702|NCT01119131|147371229|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED||||||ANOVA|||||||0.419
73921703|NCT01119131|147371230|SUPERIORITY_OR_OTHER|||||||0.253|TWO_SIDED||||||ANOVA|||||||0.253
73921704|NCT01119131|147371231|SUPERIORITY_OR_OTHER|||||||0.793|TWO_SIDED||||||ANOVA|||||||0.793
73921705|NCT01119131|147371233|SUPERIORITY_OR_OTHER|||||||0.949|TWO_SIDED||||||ANOVA|||||||0.949
73921706|NCT01119131|147371234|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANOVA|||||||0.957
73921707|NCT04339296|147371238|EQUIVALENCE|An independent sample t-test was performed between intervention and control group to determine if the difference of the mean medication adherence is equal to zero (null hypothesis).|Mean Difference (Net)|7.18|||<|0.01|TWO_SIDED|||||Statistical test was set at 95% confidence level.|t-test, 2 sided||Medication Adherence Difference = Intervention Adherence - Control Adherence|||||<0.01
73921708|NCT04339296|147371239|EQUIVALENCE|The null hypothesis assumes that the true mean difference for intervention participants self-reported medication adherence scores (from baseline to 6-month) is equal to zero.|Mean Difference (Net)|-1.5|||<|0.01|TWO_SIDED|||||Statistical test was set at 95% confidence level.|t-test, 2 sided||Mean difference (intervention participants self-reported score) = baseline minus 6-month.|||||<0.01
73921709|NCT04339296|147371239|EQUIVALENCE|The null hypothesis assumes that the true mean difference for control participants self-reported medication adherence scores (from baseline to 6-month) is equal to zero.|Mean Difference (Net)|-1.07||||0.07|TWO_SIDED|||||Statistical tests was set at 95% confidence level.|t-test, 2 sided||Mean difference (control participants self-reported score) = baseline minus 6-month.|||||0.07
73931034|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|2.05|||<|0.001||95.0|1.82|2.31|||cLDA model||V116/PPSV23|Serotype 11A: V116/PPSV23 GMT Ratio||2.31|1.82|<0.001
73921710|NCT04446377|147371247|SUPERIORITY|The alternative hypothesis for the statistical testing was that LAM-002A would induce greater changes in viral load from Day 1 to Day 4 than would Placebo.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.51||0.35|TWO_SIDED|95.0|-1.47|0.53||Pre-specified 2-sided significance level of 0.20|Mixed Models Analysis|ANCOVA linear mixed model to evaluate the relative differences between the LAM-002A and Placebo groups in the log10 viral load from Day 1 to Day 4.|The difference between the groups (LAM-002A vs Placebo).|The analysis tested whether the viral load in nasopharyngeal samples was lower at Day 4 in those receiving LAM-002A compared to Placebo.||0.53|-1.47|0.35
73921711|NCT04446377|147371249|SUPERIORITY|The alternative hypothesis for the statistical testing was that LAM-002A would reduce the cumulative rate of hospitalization or death during the 28-day period comprising 10 days of study drug administration and a further 18 days of observation.|Odds Ratio (OR)|2.03||||0.55|TWO_SIDED|95.0|0.18|22.89|||Log Rank|||||22.89|0.18|0.55
73921712|NCT04446377|147371251|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-1.4|||||TWO_SIDED|||||||||Risk Difference from generalized estimating equations (GEE) logistic regression at Baseline||||
73921713|NCT04446377|147371251|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-1.0|||||TWO_SIDED|||||||||Risk Difference from GEE Logistic Regression at Day 1||||
73921714|NCT04446377|147371251|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-8.8|||||TWO_SIDED|||||||||Risk Difference from GEE logistic regression at Day 4||||
73921715|NCT04446377|147371251|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-3.7|||||TWO_SIDED|||||||||Risk Difference from GEE logistic regression at Day 11||||
73921716|NCT04446377|147371252|SUPERIORITY|The alternative hypothesis for the statistical testing was that, relative to Placebo, LAM-002A would result in a greater proportion of participants with a SARS-CoV-2 viral load \<LLOQ on Day 4.|Relative Risk|2.51||||0.2|TWO_SIDED|95.0|0.74|8.48||Prespecified significance level of 0.20.|Fisher Exact|||||8.48|0.74|0.20
73921717|NCT03557151|147371259|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.33||0.895|TWO_SIDED|95.0|-0.68|0.6|||Mixed Models Analysis|||Transdisciplinary Care is being compared to Usual Care using the Time 2 HbA1c (as baseline) and Time 5 HbA1c (as the outcome) controlling for race/ethnicity, gender, and age of the patient. The interaction of condition and time is used to evaluate the treatment effect. Missing data were not imputed.||0.60|-0.68|0.895
73921718|NCT03557151|147371260|SUPERIORITY||Slope|2.29|STANDARD_ERROR_OF_MEAN|2.34||0.33|TWO_SIDED|95.0|-2.29|6.88|||Mixed Models Analysis|||TC is being compared to UC using baseline and 12 month data, controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to examine the treatment effect. Missing data were not imputed.||6.88|-2.29|.33
73967534|NCT03562377|147472418|SUPERIORITY||Risk Difference (RD)|12.7||||0.057|TWO_SIDED|95.0|-0.2|25.7||The p-value was adjusted for multiplicity by a pre-specified testing hierarchy. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.|Cochran-Mantel-Haenszel|The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by baseline disease severity (moderate or severe).||||25.7|-0.2|0.057
73921719|NCT03557151|147371261|SUPERIORITY||Slope|4.1|STANDARD_ERROR_OF_MEAN|2.25||0.07|TWO_SIDED|95.0|-0.32|8.53|||Mixed Models Analysis|||TC is being compared to UC using baseline and 12 month data and controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to evaluate the treatment effect. Missing data are not imputed.||8.53|-.32|.07
74086771|NCT00810602|147727386|SUPERIORITY_OR_OTHER||Percent Cumulative Incidence of GVHD|22.0|||||TWO_SIDED|95.0|13.0|36.0||||||Hypothesis: The addition of vorinostat will reduce the incidence of grade 2-4 acute graft versus host disease (GVHD) to 25% or lower by day 100.||36|13|
73921720|NCT03557151|147371262|SUPERIORITY||Slope|-2.38|STANDARD_ERROR_OF_MEAN|3.77||0.527|TWO_SIDED|95.0|-9.77|5.0|||Mixed Models Analysis|||This analysis included baseline and 12-month data. The interaction of condition (TC or UC) and time was used to examine the treatment effect. Child sex, age, and race/ethnicity were covariates. Missing data were not imputed.||5.0|-9.77|.527
73921721|NCT03557151|147371263|SUPERIORITY||Slope|-3.3|STANDARD_ERROR_OF_MEAN|2.89||0.253|TWO_SIDED|95.0|-8.94|2.35|||Mixed Models Analysis|||This analysis uses baseline and 12 month data. The interaction of condition and time is used to evaluate the treatment effect. Child sex, age, and race/ethnicity were used as covariates. Missing data were not imputed.||2.35|-8.94|.253
73921722|NCT03557151|147371264|SUPERIORITY||Slope|9.69|STANDARD_ERROR_OF_MEAN|3.77||0.01|TWO_SIDED|95.0|2.31|17.08|||Mixed Models Analysis|||This analysis included baseline and 12 month data. The condition by time interaction was used to evaluate the treatment effect. Child age, sex, and race/ethnicity were included as covariates. Missing data were not imputed.||17.08|2.31|0.01
74086772|NCT00810602|147727388|SUPERIORITY_OR_OTHER||Percent Cumulative Incidence of GVHD|16.0|||||TWO_SIDED|95.0|8.0|30.0||||||||30|8|
74086773|NCT01745952|147727393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9819|TWO_SIDED||||||negative binomial model + overdispersion|||||||0.9819
74086774|NCT02688387|147727475|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0667|||||TWO_SIDED|90.0|0.9657|1.1784|||||X1 Vs R1, ambrisentan|||1.1784|0.9657|
74086775|NCT02688387|147727475|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0353|||||TWO_SIDED|90.0|0.9293|1.1534|||||X2 Vs R2, ambrisentan|||1.1534|0.9293|
73967535|NCT01180634|147472428|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.0715|TWO_SIDED|95.0|0.96|1.84||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||1.84|0.96|0.0715
73967536|NCT01180634|147472429|SUPERIORITY||LSMean difference|1.41||||0.0213|TWO_SIDED|95.0|0.21|2.6|||Repeared Measures Model||Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||2.60|0.21|0.0213
73967537|NCT01180634|147472430|SUPERIORITY||LSMean difference|-0.63||||0.0002|TWO_SIDED|95.0|-0.95|-0.3|||Repeated Measures Model||Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.|||-0.30|-0.95|0.0002
73967538|NCT01180634|147472431|SUPERIORITY||LSMean difference|0.28||||0.8335|TWO_SIDED|95.0|-2.3|2.85|||Repeated Measures Model||Estimates were determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12 to 18 years, \> 18 years), Baseline FEV1 (\<55%, ≥ 55%), and Baseline value.|||2.85|-2.30|0.8335
73967539|NCT01180634|147472432|SUPERIORITY||LSMean difference|2.42||||0.0122|TWO_SIDED|95.0|0.53|4.31|||Repeated Measures Model|||||4.31|0.53|0.0122
73967540|NCT01180634|147472433|SUPERIORITY||Cox Proportional Hazard|0.82||||0.3|TWO_SIDED|95.0|0.6|1.12||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||1.12|0.60|0.3000
73967541|NCT01180634|147472434|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.867|TWO_SIDED|95.0|0.47|2.04||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||2.04|0.47|0.8670
73921723|NCT03557151|147371265|SUPERIORITY||Slope|0.45|STANDARD_ERROR_OF_MEAN|2.07||0.83|TWO_SIDED|95.0|-3.62|4.35|||Mixed Models Analysis|||This analysis uses baseline and 12-month data. The interaction between condition and time is used to evaluate the treatment effect. Child age, sex, and race/ethnicity were covariates. Missing data were not imputed.||4.35|-3.62|.83
73967542|NCT04419168|147472436|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.57|TWO_SIDED|95.0|-1.3|2.37|||Mixed Models Analysis|||||2.37|-1.30|.57
73967543|NCT04419168|147472437|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.79|TWO_SIDED|95.0|-0.46|0.61|||Mixed Models Analysis|||||0.61|-0.46|0.79
74028185|NCT01380093|147610107|SUPERIORITY_OR_OTHER||LS Mean Difference|20.6|||<|0.0001|TWO_SIDED|95.0|14.4|26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||26.8|14.4|<0.0001
74028186|NCT01380093|147610108|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-55.6|-20.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-20.8|-55.6|<0.0001
73921724|NCT01414075|147371266|OTHER|||||||0.0757||||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.0757
73921725|NCT01414075|147371266|OTHER|||||||0.063||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.0630
73921726|NCT01414075|147371266|OTHER|||||||0.8653||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.8653
73967544|NCT04419168|147472438|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.75|TWO_SIDED|95.0|-1.55|1.12|||Mixed Models Analysis|||||1.12|-1.55|0.75
73967545|NCT04419168|147472439|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.31|TWO_SIDED|95.0|-0.6|1.87|||Mixed Models Analysis|||||1.87|-0.60|0.31
73967546|NCT04419168|147472440|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.91|TWO_SIDED|95.0|-1.77|1.99|||Mixed Models Analysis|||These results correspond to ASCQ-Me Social Functioning Impact only.||1.99|-1.77|0.91
73967547|NCT04419168|147472440|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.05|TWO_SIDED|95.0|-0.03|3.46|||Mixed Models Analysis|||These results correspond to ASCQ-Me Emotional Impact only.||3.46|-0.03|0.05
73967548|NCT04419168|147472441|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.12|TWO_SIDED|95.0|-0.31|2.56|||Mixed Models Analysis|||||2.56|-0.31|0.12
73967549|NCT04419168|147472442|SUPERIORITY||Mean Difference (Final Values)|-0.0024||||0.91|TWO_SIDED|95.0|-0.0443|0.0395|||Mixed Models Analysis|||||0.0395|-0.0443|0.91
73967550|NCT04419168|147472443|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.68|TWO_SIDED|95.0|-1.61|2.48|||Mixed Models Analysis|||||2.48|-1.61|0.68
73967551|NCT04419168|147472444|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.75|TWO_SIDED|95.0|-0.46|0.63|||Mixed Models Analysis|||||0.63|-0.46|0.75
73967552|NCT04419168|147472445|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.14|TWO_SIDED|95.0|-2.56|0.35|||Mixed Models Analysis|||||0.35|-2.56|0.14
74028187|NCT01380093|147610108|SUPERIORITY_OR_OTHER||LS Mean Difference|34.4||||0.0002|TWO_SIDED|95.0|17.0|51.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||51.7|17.0|0.0002
74028188|NCT01380093|147610108|SUPERIORITY_OR_OTHER||LS Mean Difference|72.6|||<|0.0001|TWO_SIDED|95.0|55.2|90.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||90.0|55.2|<0.0001
74028189|NCT01380093|147610109|SUPERIORITY_OR_OTHER||LS Mean Difference|-100.3|||<|0.0001|TWO_SIDED|95.0|-142.2|-58.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-58.4|-142.2|<0.0001
73861562|NCT02699450|147269020|SUPERIORITY||Difference in Least Squares Means|6.6||||0.43|TWO_SIDED|80.0|-4.0|17.2||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||17.2|-4.0|0.43
73861563|NCT02699450|147269020|SUPERIORITY||Difference in Least Squares Means|7.2||||0.34|TWO_SIDED|80.0|-2.6|17.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||17.0|-2.6|0.34
73921727|NCT01414075|147371266|OTHER|||||||0.8982||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.8982
73967553|NCT04419168|147472446|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.75|TWO_SIDED|95.0|-1.69|1.21|||Mixed Models Analysis|||||1.21|-1.69|0.75
73921728|NCT01722071|147371324|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 18 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.890
73921729|NCT01722071|147371324|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 8 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.422
73921730|NCT01722071|147371324|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 10 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.814
73921731|NCT00680043|147371341|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|97.5|-0.79|0.29|||ANOVA|||||0.29|-0.79|
73921732|NCT00680043|147371341|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|97.5|-0.56|0.52|||ANOVA|||||0.52|-0.56|
73921733|NCT00680043|147371343|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.84|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.84|
73921734|NCT00680043|147371343|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.92|1.03|||Cochran-Mantel-Haenszel|||||1.03|0.92|
73921735|NCT00553150|147371344|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|70.0|||||TWO_SIDED|||||||||||||
73921736|NCT03061331|147371350|SUPERIORITY||Least Squares Mean Difference|0.1||||0.9277|TWO_SIDED|95.0|-2.5|2.7|||Mixed Model Repeated Measure (MMRM)|||||2.7|-2.5|0.9277
73921737|NCT02625259|147371367|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.36|||||TWO_SIDED|90.0|1.0|1.83||||||Analysis of variance was performed for calculating 90 percent (%) confidence intervals (CIs) for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet versus capsule dosage form.||1.83|1.00|
73967554|NCT04419168|147472447|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.49|TWO_SIDED|95.0|-1.3|2.71|||Mixed Models Analysis|||These results correspond to ASCQ-Me Social Functioning Impact only.||2.71|-1.30|0.49
73967555|NCT04419168|147472447|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.037|TWO_SIDED|95.0|0.12|3.88|||Mixed Models Analysis|||These results correspond to ASCQ-Me Emotional Impact only.||3.88|0.12|0.037
73967556|NCT04419168|147472448|SUPERIORITY||Mean Difference (Final Values)|2.13||||0.008|TWO_SIDED|95.0|0.56|3.71|||Mixed Models Analysis|||||3.71|0.56|0.008
73921738|NCT02625259|147371367|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.2|||||TWO_SIDED|90.0|0.86|1.67||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with food versus without food.||1.67|0.86|
73921739|NCT02625259|147371367|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.03|||||TWO_SIDED|90.0|0.02|0.07||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.07|0.02|
73921740|NCT02625259|147371369|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.47|||||TWO_SIDED|90.0|0.98|2.18||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet versus capsule dosage form.||2.18|0.98|
73921741|NCT02625259|147371369|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.76|||||TWO_SIDED|90.0|1.11|2.78||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with food versus without food.||2.78|1.11|
73967557|NCT04419168|147472449|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.56|TWO_SIDED|95.0|-1.51|0.82|||Mixed Models Analysis|||||0.82|-1.51|0.56
73967558|NCT04419168|147472450|SUPERIORITY||Mean Difference (Final Values)|-0.0013||||0.95|TWO_SIDED|95.0|-0.0464|0.0437|||Mixed Models Analysis|||||0.0437|-0.0464|0.95
73967559|NCT04419168|147472451|SUPERIORITY||Incidence Rate Ratio|1.11||||0.49|TWO_SIDED|95.0|0.83|1.48|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||1.48|0.83|0.49
73967560|NCT04419168|147472452|SUPERIORITY||Incidence Rate Ratio|1.43||||0.1|TWO_SIDED|95.0|0.93|2.18|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||2.18|0.93|0.10
73921742|NCT02625259|147371369|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.02|||||TWO_SIDED|90.0|0.01|0.04||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.04|0.01|
73921743|NCT02625259|147371370|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.53|||||TWO_SIDED|90.0|0.93|2.51||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet versus capsule dosage form.||2.51|0.93|
73921744|NCT02625259|147371370|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.5|||||TWO_SIDED|90.0|1.0|2.25||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with food versus without food.||2.25|1.00|
73921745|NCT02625259|147371370|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.08|||||TWO_SIDED|90.0|0.03|0.18||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.18|0.03|
73921746|NCT00513474|147371372|SUPERIORITY|||||||0.036|||||||Gray's test for competing risks|||||||.036
73921747|NCT01765153|147371424|SUPERIORITY_OR_OTHER|||||||0.04366667|||||||t-test, 2 sided|||||||0.04366667
73921748|NCT01662908|147371575|OTHER||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|10.74|||TWO_SIDED|95.0|-12.7|30.2||||||||30.2|-12.7|
73921749|NCT00312494|147371580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1077||95.0||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||N=135/arm (405 total) for 85% power for 2-sample t-test (2-sided alpha=0.05) based on true mean difference=3.5 and SD=10. Interim Analysis (IA) to validate sample-size assumptions and adjust sample-size if needed. Based on IA results total sample-size increased to N=223/arm (669 total) to maintain desired power. Null Hypothesis=No statistically significant difference between add-on ziprasidone (higher, lower dose) and add-on placebo groups with respect to the population mean for primary endpoint||||0.1077
73921750|NCT00312494|147371580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4274||95.0||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||Week 3 Mixed Model Repeated Measures (MMRM) with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score. Tests were 2-sided and performed at the 0.05 significance level.||||0.4274
73921751|NCT00312494|147371581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4025||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.4025
73921752|NCT00312494|147371581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.2830
73921753|NCT00312494|147371581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4125||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.4125
73921754|NCT00312494|147371581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1527||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.1527
73921755|NCT00312494|147371582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0101||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0101
73921756|NCT00312494|147371582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0694||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0694
73921757|NCT00312494|147371582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0183||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0183
73921758|NCT00312494|147371582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0176||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0176
73921759|NCT00312494|147371582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2302||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.2302
73921760|NCT00312494|147371582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0796||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0796
73921761|NCT00312494|147371583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6191||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.6191
73921762|NCT00312494|147371583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5629||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.5629
73967561|NCT04419168|147472453|SUPERIORITY||Incidence Rate Ratio|1.31||||0.22|TWO_SIDED|95.0|0.85|2.03|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||2.03|0.85|0.22
74028190|NCT01380093|147610109|SUPERIORITY_OR_OTHER||LS Mean Difference|93.9|||<|0.0001|TWO_SIDED|95.0|52.1|135.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||135.7|52.1|<0.0001
74028191|NCT01380093|147610109|SUPERIORITY_OR_OTHER||LS Mean Difference|194.2|||<|0.0001|TWO_SIDED|95.0|152.3|236.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||236.1|152.3|<0.0001
74086776|NCT02688387|147727475|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9839|||||TWO_SIDED|90.0|0.9288|1.0423|||||X1 Vs R1, tadalafil|||1.0423|0.9288|
73921763|NCT00312494|147371583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9049||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.9049
73921764|NCT00312494|147371583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7153||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.7153
73921765|NCT00312494|147371583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.2420
73921766|NCT00312494|147371583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6121||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.6121
73967562|NCT05009251|147472454|SUPERIORITY|||||||0.054|||||||Regression, Linear|||This analysis compared groups that were informed they were high risk (High Risk Only, High Risk Based on Medical Records, High Risk Based on Algorithm) to Reminder Control patients who were sent messages that did not disclose their risk status. Null hypothesis: messages that inform patients they are high risk do not increase flu vaccination rate vs. messages that do not disclose risk status; Alternative hypothesis: messages that inform patients they are high risk increase flu vaccination rate.||||.054
73921767|NCT00312494|147371584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6138||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.6138
73921768|NCT00312494|147371584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6536||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.6536
73921769|NCT00312494|147371584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4758||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.4758
73921770|NCT00312494|147371584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7581||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.7581
73921771|NCT00312494|147371584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2221||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.2221
74028192|NCT01380093|147610110|SUPERIORITY_OR_OTHER||LS Mean Difference|-147.4|||<|0.0001|TWO_SIDED|95.0|-205.1|-89.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-89.6|-205.1|<0.0001
74028193|NCT01380093|147610110|SUPERIORITY_OR_OTHER||LS Mean Difference|134.1|||<|0.0001|TWO_SIDED|95.0|76.5|191.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||191.7|76.5|<0.0001
74086777|NCT02688387|147727475|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9656|||||TWO_SIDED|90.0|0.9151|1.0188|||||X2 Vs R2, tadalafil|||1.0188|0.9151|
73921772|NCT00312494|147371584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5665||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.5665
73921773|NCT00312494|147371585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1063||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.||||0.1063
73921774|NCT00312494|147371585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2499||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.||||0.2499
73921775|NCT00312494|147371585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0876||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.||||0.0876
73921776|NCT00312494|147371585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3623||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.||||0.3623
73967563|NCT05009251|147472454|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||This analysis compared groups that were informed they were high risk (High Risk Only, High Risk Based on Medical Records, High Risk Based on Algorithm) to No-Contact Control patients who were not sent messages. Null hypothesis: messages that inform patients they are high risk do not increase flu vaccination rate relative to no messages; Alternative hypothesis: messages that inform patients they are high risk increase flu vaccination rate.||||<.001
73967564|NCT05009251|147472454|SUPERIORITY|||||||0.24|||||||Regression, Linear|||This analysis compared groups who received messages including risk reasons (High Risk Based on Medical Records, High Risk Based on Algorithm) to messages that mentioned patients' risk status but do not include reasons (High Risk Only). Null hypothesis: messages that include risk reasons do not increase flu vaccination rate relative to high-risk messages that do not include risk reasons; Alternative hypothesis: messages including risk reasons are more effective at increasing vaccination rates.||||.240
73967565|NCT05009251|147472454|SUPERIORITY|||||||0.047|||||||Regression, Linear|||Null hypothesis: flu-shot messages that do not mention high-risk status do not increase vaccination relative to no messages; Alternative hypothesis: flu shot messages that do not mention high-risk status increase flu shots relative to no messages.||||.047
74028194|NCT01380093|147610110|SUPERIORITY_OR_OTHER||LS Mean Difference|281.5|||<|0.0001|TWO_SIDED|95.0|223.7|339.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||339.2|223.7|<0.0001
74086778|NCT02688387|147727476|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.03|||||TWO_SIDED|90.0|0.9965|1.0646|||||X1 Vs R1, ambrisentan|||1.0646|0.9965|
73921777|NCT00312494|147371585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4686||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.||||0.4686
73967566|NCT05009251|147472454|SUPERIORITY|||||||0.781||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Only and High Risk Based on Medical Records messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Only and High Risk Based on Medical Records.||||.781
74086779|NCT02688387|147727476|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0141|||||TWO_SIDED|90.0|0.982|1.0473|||||X2 Vs R2, ambrisentan|||1.0473|0.9820|
74086780|NCT02688387|147727476|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9693|||||TWO_SIDED|90.0|0.931|1.0092|||||X1 Vs R1, tadalafil|||1.0092|0.9310|
73921778|NCT00312494|147371585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2202||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.||||0.2202
73921779|NCT00312494|147371586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0728||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.||||0.0728
73921780|NCT00312494|147371586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3174||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.||||0.3174
74028195|NCT01380093|147610111|SUPERIORITY_OR_OTHER||LS Mean Difference|-201.4|||<|0.0001|TWO_SIDED|95.0|-279.3|-123.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-123.6|-279.3|<0.0001
73921781|NCT00312494|147371587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.||||0.4460
73921782|NCT00312494|147371587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3253||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.||||0.3253
73921783|NCT02127567|147371607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.5|2.7|||Mixed Models Analysis|||||2.7|1.5|<0.001
73921784|NCT02127567|147371608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||<|0.01|TWO_SIDED|95.0|1.1|4.4|||Mixed Models Analysis|||||4.4|1.1|<0.01
73921785|NCT02127567|147371609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.44|TWO_SIDED|95.0|-0.7|2.0|||Mixed Models Analysis|||||2.0|-0.7|0.44
73921786|NCT02127567|147371610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|||<|0.01|TWO_SIDED|95.0|0.8|3.6|||Mixed Models Analysis|||||3.6|0.8|<0.01
73921787|NCT02127567|147371611|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.8|||<|0.01|TWO_SIDED|95.0|0.7|2.9|||Mixed Models Analysis|||||2.9|0.7|<0.01
73921788|NCT02127567|147371612|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.78|TWO_SIDED|95.0|-2.0|1.3|||Mixed Models Analysis|||||1.3|-2.0|0.78
73921789|NCT02127567|147371613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4|||<|0.01|TWO_SIDED|95.0|4.1|6.7|||Mixed Models Analysis|||||6.7|4.1|<0.01
74086781|NCT02688387|147727476|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0157|||||TWO_SIDED|90.0|0.9553|1.0799|||||X2 Vs R2, tadalafil|||1.0799|0.9553|
73921790|NCT02127567|147371614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.002|TWO_SIDED|95.0|0.5|2.3|||Mixed Models Analysis|||||2.3|0.5|0.002
73921791|NCT01969240|147371681|SUPERIORITY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|0.46|0.86||||||||0.86|0.46|
73921792|NCT01969240|147371682|SUPERIORITY||||||<|0.013|||||||t-test, 2 sided|The a-priori significance level was 0.05.||||||<0.013
73921793|NCT01969240|147371683|SUPERIORITY||Mean Difference (Final Values)|10.3|||||TWO_SIDED|95.0|9.1|11.5||||||||11.5|9.1|
73921794|NCT01969240|147371684|SUPERIORITY|||||||0.998|||||||Regression, Logistic|||||||0.998
73921795|NCT01969240|147371685|SUPERIORITY||||||<|0.001|||||||negative binomial model|||||||<0.001
73921796|NCT01969240|147371686|SUPERIORITY||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-4.8|-0.9||||||||-0.90|-4.8|
73921797|NCT01969240|147371687|SUPERIORITY||Median Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-0.2|3.6||||||||3.6|-0.2|
73921798|NCT00412854|147371692|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.61|||||TWO_SIDED|95.0|-1.68|3.39||||||"Difference in seroprotection rates against diphteria toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose primary vaccination course."||3.39|-1.68|
73921799|NCT00412854|147371692|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in seroprotection rates against tetanus toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
73921800|NCT00412854|147371693|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|2.47|||||TWO_SIDED|95.0|0.15|6.18||||||"Difference in seroprotection rates against PRP:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||6.18|0.15|
73921801|NCT00412854|147371694|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in vaccine response rates against PT:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
73931035|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.63|||<|0.001|TWO_SIDED|95.0|1.4|1.9|||cLDA model||V116/PPSV23|Serotype 12F: V116/PPSV23 GMT Ratio||1.90|1.40|<0.001
73931036|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|2.02|||<|0.001|TWO_SIDED|95.0|1.77|2.31|||cLDA model||V116/PPSV23|Serotype 17F: V116/PPSV23GMT Ratio||2.31|1.77|<0.001
73921802|NCT00412854|147371694|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in vaccine response rates against FHA:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
73921803|NCT00412854|147371694|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|1.23|||||TWO_SIDED|95.0|-2.17|5.07||||||"Difference in vaccine response rates against PRN:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||5.07|-2.17|
73921804|NCT04483011|147371707|SUPERIORITY||Mean Difference (Net)|2.12|STANDARD_DEVIATION|4.72||0.034|TWO_SIDED|||||\< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Dave 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.034
73921805|NCT04483011|147371707|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|2.79||0.265|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation of Comparator.||||0.265
73921806|NCT04483011|147371707|SUPERIORITY||Mean Difference (Net)|2.12|STANDARD_DEVIATION|4.72||0.044|TWO_SIDED|||||\< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator groups.||||0.044
73921807|NCT04483011|147371708|SUPERIORITY||Mean Difference (Net)|1.33|STANDARD_DEVIATION|1.88||0.008|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation of RiaGev.||||0.008
73921808|NCT04483011|147371708|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_DEVIATION|1.34||0.297|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.297
73921809|NCT04483011|147371708|SUPERIORITY||Mean Difference (Net)|1.33|STANDARD_DEVIATION|1.88||0.04|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator supplementation.||||0.04
73921810|NCT04483011|147371709|SUPERIORITY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|6.57||0.004|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in the RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.004
74086782|NCT02688387|147727477|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0278|||||TWO_SIDED|90.0|0.9943|1.0623|||||X1 Vs R1, ambrisentan|||1.0623|0.9943|
73921811|NCT04483011|147371709|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|3.88||0.64|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.640
73921812|NCT04483011|147371709|SUPERIORITY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|6.57||0.014|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator supplementation.||||0.014
73921813|NCT04483011|147371710|SUPERIORITY||Mean Difference (Net)|-1037.92|STANDARD_DEVIATION|1590.74||0.013|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 8 over Day 1 is reported.|A comparison before and after RiaGev supplementation.||||0.013
73921814|NCT04483011|147371710|SUPERIORITY||Mean Difference (Net)|-302.08|STANDARD_DEVIATION|1427.42||0.382|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 8 over Day 1 is reported.|A comparison before before and after supplementation with Comparator.||||0.382
73921815|NCT04483011|147371711|SUPERIORITY||Mean Difference (Net)|-135.13|STANDARD_DEVIATION|2153.66||0.793|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 8 over Day 1 baseline is reported.|A comparison between before and after RiaGev supplementation||||0.793
73921816|NCT04483011|147371711|SUPERIORITY||Mean Difference (Net)|-134.79|STANDARD_DEVIATION|1830.16||0.758|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 8 over Day 1 baseline is reported.|A comparison between before and after supplementation with Comparator.||||0.758
73921817|NCT04483011|147371712|SUPERIORITY||Mean Difference (Net)|70.2|STANDARD_DEVIATION|123.89||0.003|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation||||0.003
73921818|NCT04483011|147371712|SUPERIORITY||Mean Difference (Net)|15.55|STANDARD_DEVIATION|88.62||0.766|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.766
73921819|NCT04483011|147371713|SUPERIORITY||Mean Difference (Net)|24.01|STANDARD_DEVIATION|58.2||0.029|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 is reported.|A comparison between RiaGev and Comparator groups after 7-day supplementation.||||0.029
73921820|NCT04483011|147371714|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_DEVIATION|0.32||0.034|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 is reported.|A comparison between RiaGev and Comparator groups.||||0.034
73921821|NCT04483011|147371715|SUPERIORITY||Mean Difference (Net)|-8.33|STANDARD_DEVIATION|12.99||0.014|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.014
73921822|NCT04483011|147371715|SUPERIORITY||Mean Difference (Net)|-2.56|STANDARD_DEVIATION|5.66||0.049|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.049
73921823|NCT03518073|147371719|SUPERIORITY||Posterior Mean Ratio|1.1|||||TWO_SIDED|95.0|0.959|1.265|||||Posterior mean ratio with 95% credible interval is reported.|||1.265|0.959|
74028196|NCT01380093|147610111|SUPERIORITY_OR_OTHER||LS Mean Difference|169.1|||<|0.0001|TWO_SIDED|95.0|91.5|246.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||246.7|91.5|<0.0001
74028197|NCT01380093|147610111|SUPERIORITY_OR_OTHER||LS Mean Difference|370.5|||<|0.0001|TWO_SIDED|95.0|292.7|448.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||448.4|292.7|<0.0001
73921824|NCT03518073|147371719|SUPERIORITY||Posterior Mean Ratio|1.05|||||TWO_SIDED|95.0|0.907|1.209|||||Posterior mean ratio with 95% credible interval is reported.|||1.209|0.907|
73921825|NCT03518073|147371720|SUPERIORITY||Posterior Mean Ratio|1.11|||||TWO_SIDED|95.0|0.943|1.29|||||Posterior mean ratio with 95% credible interval is reported.|||1.290|0.943|
73921826|NCT03518073|147371720|SUPERIORITY||Posterior Mean Ratio|0.89|||||TWO_SIDED|95.0|0.737|1.053|||||Posterior mean ratio with 95% credible interval is reported.|||1.053|0.737|
73921827|NCT03518073|147371721|SUPERIORITY||Posterior Mean Ratio|1.06|||||TWO_SIDED|95.0|0.873|1.284|||||Posterior mean ratio with 95% credible interval is reported.|||1.284|0.873|
73921828|NCT03518073|147371721|SUPERIORITY||Posterior Mean Ratio|1.21|||||TWO_SIDED|95.0|1.006|1.453|||||Posterior mean ratio with 95% credible interval is reported.|||1.453|1.006|
73921829|NCT03518073|147371722|SUPERIORITY||Posterior Mean Ratio|1.12|||||TWO_SIDED|95.0|0.963|1.3|||||Posterior mean ratio with 95% credible interval is reported.|||1.300|0.963|
73921830|NCT03518073|147371722|SUPERIORITY||Posterior Mean Ratio|0.95|||||TWO_SIDED|95.0|0.805|1.119|||||Posterior mean ratio with 95% credible interval is reported.|||1.119|0.805|
73921831|NCT03518073|147371723|SUPERIORITY||Posterior Mean Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.221|||||Posterior mean ratio with 95% credible interval is reported.|||1.221|0.880|
73921832|NCT03518073|147371723|SUPERIORITY||Posterior Mean Ratio|0.89|||||TWO_SIDED|95.0|0.742|1.065|||||Posterior mean ratio with 95% credible interval is reported.|||1.065|0.742|
73921833|NCT03518073|147371724|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.253|TWO_SIDED|95.0|-0.01|0.05|||Mixed Models Analysis|||||0.05|-0.01|0.253
73921834|NCT03518073|147371724|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.354|TWO_SIDED|95.0|-0.02|0.05|||Mixed Models Analysis|||||0.05|-0.02|0.354
73921835|NCT03518073|147371725|SUPERIORITY||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|1.554||0.691|TWO_SIDED|95.0|-2.44|3.68|||Mixed Models Analysis|||||3.68|-2.44|0.691
73921836|NCT03518073|147371725|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.599||0.749|TWO_SIDED|95.0|-2.64|3.66|||Mixed Models Analysis|||||3.66|-2.64|0.749
73921837|NCT03045081|147371728|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. GEE allows for the analysis of repeated measures with unknown covariance structure and uses all available data that participants provide, even if follow-up data are missing (ie, intent-to-treat analysis). Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; i.e., as treated 'completer' analysis) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interactions.|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in pain self efficacy over time compared to the usual care group.||||<0.05
73921838|NCT03045081|147371728|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 values \< 0.05 considered statistically significant for group x time interactions.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain self-efficacy over time compared to the usual care group. This analysis was limited to those participants who provided data at each of the study time points ('completer analysis').||||<0.05
73921839|NCT03045081|147371729|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; 'study completers') were evaluated (see Statistical Analysis 2).||||||0.068||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group. Note: this questionnaire has 2 subscales, Activity Engagement and Pain Willingness. Intent-to-treat and as treated analyses were conducted for each subscale.||||0.068
73921840|NCT03045081|147371729|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 \<0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group.This analysis was limited to those participants who provided data at each of the study time points ('completer' analysis).||||<0.05
73921841|NCT03045081|147371729|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.||||||0.173||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group.||||0.173
73931037|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.42|||<|0.001|TWO_SIDED|95.0|1.26|1.6|||cLDA model||V116/PPSV23|Serotype 19A: V116/PPSV23 GMT Ratio||1.60|1.26|<0.001
74028198|NCT01380093|147610112|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.4|||<|0.0001|TWO_SIDED|95.0|-23.8|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.0|-23.8|<0.0001
73921842|NCT03045081|147371729|OTHER|Generalized estimating equations were used to test this hypothesis.||||||0.167||||||Wald χ2 \>0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).||||0.167
73921843|NCT03045081|147371730|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).||||||0.176||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group.||||0.176
73921844|NCT03045081|147371730|OTHER|Generalized estimating equations were used to test this hypothesis.||||||0.143||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).||||0.143
73921845|NCT03045081|147371731|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values \< 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group.||||<0.05
73921846|NCT03045081|147371731|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.001||||||Wald χ2 \< 0.05 were considered statistically significant for the group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points (i.e., 'completer' analysis).||||<0.001
73921847|NCT03045081|147371733|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).||||||0.102||||||Wald χ2 p-values \< 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group.||||0.102
73921848|NCT03045081|147371733|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each time point (as treated, 'completer' analysis).||||<0.05
73921849|NCT01853046|147371736|SUPERIORITY_OR_OTHER||LS Mean|1.14|||||TWO_SIDED|90.0|0.796|1.63||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of regorafenib calculated by re-transformation of the logarithmic data from ANOVAs.||1.63|0.796|
73967567|NCT05009251|147472454|SUPERIORITY|||||||0.361||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Only and High Risk Based on Algorithm messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Only and High Risk Based on Algorithm.||||.361
73921850|NCT01853046|147371736|SUPERIORITY_OR_OTHER||LS-means|0.684|||||TWO_SIDED|90.0|0.397|1.18||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-2 calculated by re-transformation of the logarithmic data from ANOVAs.||1.18|0.397|
73921851|NCT01853046|147371736|SUPERIORITY_OR_OTHER||LS-means|0.446|||||TWO_SIDED|90.0|0.2|0.996||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-5 calculated by re-transformation of the logarithmic data from ANOVAs||0.996|0.200|
73921852|NCT02057198|147371773|SUPERIORITY||Slope|-0.15||||0.52|TWO_SIDED|95.0|-0.34|0.05||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||||0.05|-0.34|0.52
73921853|NCT02057198|147371773|SUPERIORITY||Slope|-0.17||||0.66|TWO_SIDED|95.0|-0.69|0.35||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||||0.35|-0.69|0.66
73921854|NCT02057198|147371774|SUPERIORITY||||||<|0.001|||||||Chi square (2 proportion test)|||||||<0.001
73921855|NCT02057198|147371774|SUPERIORITY|||||||0.01|||||||Chi square (2 proportion test)|||||||0.01
73921856|NCT02057198|147371775|SUPERIORITY|||||||0.99|||||||Chi square (2 proportion test)|||||||0.99
74028199|NCT01380093|147610112|SUPERIORITY_OR_OTHER||LS Mean Difference|25.7|||<|0.0001|TWO_SIDED|95.0|18.3|33.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.1|18.3|<0.0001
73921857|NCT02057198|147371775|SUPERIORITY|||||||0.52|||||||Chi square (2 proportion test)|||||||0.52
73921858|NCT02057198|147371776|SUPERIORITY||Slope|-0.43||||0.05|TWO_SIDED|95.0|-0.67|-0.19|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.||-0.19|-0.67|0.05
73921859|NCT02057198|147371776|SUPERIORITY||Slope|-0.85||||0.002|TWO_SIDED|95.0|-1.14|-0.57|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.||-0.57|-1.14|0.002
73921860|NCT02057198|147371778|SUPERIORITY|||||||0.48|||||||Chi square (two proportion test)|||||||0.48
73921861|NCT02057198|147371778|SUPERIORITY|||||||0.66|||||||Chi square (two proportion test)|||||||0.66
73921862|NCT01985581|147371779|SUPERIORITY_OR_OTHER||LS mean difference|-3.0||||0.0392|TWO_SIDED|95.0|-5.9|-0.2|||ANOVA|||||-0.2|-5.9|0.0392
73921863|NCT01985581|147371780|SUPERIORITY_OR_OTHER||LS mean difference|0.3||||0.894|TWO_SIDED|95.0|-4.0|4.6|||ANOVA|||||4.6|-4.0|0.894
73921864|NCT01985581|147371781|SUPERIORITY_OR_OTHER||LS mean difference|-6.2||||0.0001|TWO_SIDED|95.0|-9.1|-3.2|||ANOVA|||||-3.2|-9.1|0.0001
73921865|NCT01985581|147371783|SUPERIORITY_OR_OTHER||LS mean difference|0.3||||0.8706|TWO_SIDED|95.0|-3.2|3.7|||ANOVA|||||3.7|-3.2|0.8706
73921866|NCT03878745|147371787|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> 0, we can conclude in superiority.|Overall Mean|0.21|||||TWO_SIDED|95.0|0.07|0.35||||||||0.35|0.07|
73967568|NCT05009251|147472454|SUPERIORITY|||||||0.77||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Based on Medical Records and High Risk Based on Algorithm messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Based on Medical Records and High Risk Based on Algorithm.||||.770
73921867|NCT03878745|147371788|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.6|1.6||||||||1.6|-1.6|
73921868|NCT03878745|147371789|OTHER||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.6|0.1||||||||0.1|-3.6|
73921869|NCT03878745|147371790|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Terumo PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Median Difference (Final Values)|-0.5|||<|0.001|ONE_SIDED|95.0||-0.026|||Mixed Models Analysis|||||-0.026||<0.001
73921870|NCT03878745|147371791|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.2|1.2||||||||1.2|-1.2|
73921871|NCT00546637|147371835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1959||95.0|-0.9|0.2||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (Net) = Least squares mean|The null hypothesis was that the mean change from Baseline in 24-hour micturition-related urgency was the same at Week 12 for the two treatment groups: fesoterodine + alpha-blocker vs. placebo + alpha-blocker. It was estimated that 900 randomized subjects would have 85% power to detect a mean difference of -0.93(SD = 4.15) between the 2 treatments on the primary endpoint,mean reduction of micturition-related urgency episodes/24hr from Baseline to Week 12,assuming a 10% non-evaluability rate.||0.2|-0.9|0.1959
73921872|NCT00546637|147371836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0621||95.0|-1.0|0.0||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|||0.0|-1.0|0.0621
73921873|NCT00546637|147371838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0056||95.0|-0.8|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.1|-0.8|0.0056
73921874|NCT00546637|147371838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.009||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||-0.1|-0.7|0.0090
74028200|NCT01380093|147610112|SUPERIORITY_OR_OTHER||LS Mean Difference|42.1|||<|0.0001|TWO_SIDED|95.0|34.7|49.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||49.5|34.7|<0.0001
73921875|NCT00546637|147371839|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4||||0.0012
73921876|NCT00546637|147371839|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 12||||0.0027
73921877|NCT00546637|147371840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1112||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.2|0.1112
73921878|NCT00546637|147371840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0855||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.0|-0.3|0.0855
73921879|NCT00546637|147371842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.3847||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.3847
73921880|NCT00546637|147371842|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.4449||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.4449
73967569|NCT00616967|147472473|SUPERIORITY_OR_OTHER_LEGACY||Pathological complete response rate|0.274|||||TWO_SIDED|95.0|0.169|0.402|||||The Estimation Parameter provided above is for overall pCR for both arms combined. We estimated pCR for each arm separately as well.|Patients were stratified by hormone receptor status and randomly assigned to either arm 1 or 2. This study was designed using Simon's two-stage design for each arm in parallel. Interim analysis of early stopping for futility was conducted for the first 32 patients (16 patients per arm) and the study proceeded as more than 2 patients achieved a pCR in each arm (31 patients per arm). This design had 80% power to detect a 25% pCR rate versus a null rate of 10% with a type I error rate of 0.10.||0.402|0.169|
73967570|NCT00616967|147472473|SUPERIORITY_OR_OTHER_LEGACY||pCR in placebo arm (arm 1)|0.29|||||TWO_SIDED|95.0|0.142|0.48||||||||0.48|0.142|
73967571|NCT00616967|147472473|SUPERIORITY_OR_OTHER_LEGACY||pCR in vorinostat arm (arm 2)|0.258|||||TWO_SIDED|95.0|0.119|0.446||||||||0.446|0.119|
73967572|NCT00616967|147472476|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.1||||0.023|TWO_SIDED|95.0|1.3|22.7|||Regression, Logistic|||The estimates provided are based upon a multivariate analysis using a logistic regression adjusting for hormone receptor status. Patients with ≥50% reduction in SULmax were more likely to achieve a pCR.||22.7|1.3|0.023
73967573|NCT02910583|147472485|SUPERIORITY||Difference in Rates|4.7||||0.1475|TWO_SIDED|95.0|-1.6|10.9||P-value is from Z test for the difference of two proportions based on Kaplan-Meier estimates with standard error of each arm computed using Greenwood's formula.|Z test||comparison: ibrutininb vs. placebo|||10.9|-1.6|0.1475
73967574|NCT02910583|147472486|SUPERIORITY||||||<|0.0001||||||One-sided P-value from asymptotic test for the binomial proportion (CRR \<= 37% vs CRR \> 37%).|asymptotic test for binomial proportion|||||||< 0.0001
73967575|NCT05059262|147472515|SUPERIORITY||Difference in ORR|39.0|||<|0.0001|TWO_SIDED|95.0|28.4|49.6||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on Interactive Response Technology (IRT).|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT|||49.6|28.4|<0.0001
73967576|NCT05059262|147472516|SUPERIORITY||Difference in ORR|67.2|||<|0.0001|TWO_SIDED|95.0|57.0|77.3||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT.|||77.3|57.0|<0.0001
73967577|NCT05059262|147472517|SUPERIORITY||LS Mean Difference|14.6||||0.0077|TWO_SIDED|95.0|4.0|25.3||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.)+joint type (knee, ankle, or other)+the most impaired ROM baseline value.|Mixed model repeated measures|||||25.3|4.0|0.0077
73967578|NCT05059262|147472518|SUPERIORITY||LS Mean Difference|3.3||||0.0007|TWO_SIDED|95.0|1.4|5.2||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+PROMIS-PF baseline value.|Mixed model repeated measures|||||5.2|1.4|0.0007
74086783|NCT02688387|147727477|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0144|||||TWO_SIDED|90.0|0.9832|1.0466|||||X2 Vs R2, ambrisentan|||1.0466|0.9832|
73921881|NCT00546637|147371844|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.33||||0.0062||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.0062
73921882|NCT00546637|147371844|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.0825||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.0825
73921883|NCT00546637|147371845|SUPERIORITY_OR_OTHER|||||||0.0025||95.0||||P-value for median was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4||||0.0025
73921884|NCT00546637|147371846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1748||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.3|0.1748
73921885|NCT00546637|147371846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6572||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.2|-0.1|0.6572
73967579|NCT05059262|147472519|SUPERIORITY||LS Mean Difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.1||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+Worst Stiffness NRS baseline value.|Mixed model repeated measures|||||-1.1|-2.5|<0.0001
73921886|NCT00546637|147371848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.0051||95.0|-2.9|-0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.5|-2.9|0.0051
73921887|NCT00546637|147371848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1231||95.0|-2.3|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.3|-2.3|0.1231
73921888|NCT00546637|147371849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.3579||95.0|-1.0|0.4||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.4|-1.0|0.3579
73921889|NCT00546637|147371849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9274||95.0|-0.8|0.7||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.7|-0.8|0.9274
73921890|NCT00546637|147371850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0223||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.1|-0.7|0.0223
73921891|NCT00546637|147371850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1744||95.0|-0.6|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.1|-0.6|0.1744
73921892|NCT00546637|147371851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7564||95.0|-0.4|0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.5|-0.4|0.7564
73921893|NCT00546637|147371851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.401||95.0|-0.3|0.7||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.7|-0.3|0.4010
73921894|NCT00546637|147371852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1472||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.2|0.1472
73967580|NCT05059262|147472520|SUPERIORITY||LS Mean Difference|7.4||||0.0155|TWO_SIDED|95.0|1.4|13.4||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+VAS baseline value.|Mixed model repeated measures|||||13.4|1.4|0.0155
73967581|NCT05059262|147472521|SUPERIORITY||Difference in responder rate|26.2||||0.0056|TWO_SIDED|95.0|9.5|42.8||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT.|||42.8|9.5|0.0056
74028201|NCT01380093|147610113|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4||||0.0253|TWO_SIDED|95.0|-2.6|-0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.2|-2.6|0.0253
74028202|NCT01380093|147610113|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|1.6|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.0|1.6|<0.0001
73921895|NCT00546637|147371852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5839||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.1|-0.2|0.5839
73921896|NCT00546637|147371853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6621||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q1||0.2|-0.1|0.6621
73967582|NCT03205800|147472524|SUPERIORITY||||||<|0.05|||||||Wilcoxon signed rank test|||||||<0.05
73967583|NCT04501861|147472596|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure.|Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.043|0.022|||Mixed Models Analysis|||||0.022|-0.043|0.53
74028203|NCT01380093|147610113|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2|||<|0.0001|TWO_SIDED|95.0|3.0|5.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.4|3.0|<0.0001
74028204|NCT01380093|147610114|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1||||0.0062|TWO_SIDED|95.0|-3.7|-0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.6|-3.7|0.0062
73921897|NCT00546637|147371853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.5|-0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q2||-0.2|-0.5|<.0001
73921898|NCT00546637|147371853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3242||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q3||0.2|-0.1|0.3242
73921899|NCT00546637|147371853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1604||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q4||0.0|-0.3|0.1604
73921900|NCT00546637|147371853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4102||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q5||0.1|-0.2|0.4102
73921901|NCT00546637|147371853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3079||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q6||0.2|-0.1|0.3079
73921902|NCT00546637|147371853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4066|TWO_SIDED|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q7||0.2|-0.1|0.4066
73967584|NCT04501861|147472596|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who with preop PH received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure. The number of patients in norepinephrine group is 52 and in vasopressin group is 40. The significance level was 0.05 for all analyses. All tests were 2-sided. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-0.022||||0.26|TWO_SIDED|95.0|-0.061|0.016|||Mixed Models Analysis|||mPAP-to-MAP ratio was compared between patients with pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension.||0.016|-0.061|0.26
73967585|NCT04501861|147472596|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who without preop PH received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure. The number of patients in norepinephrine group is 31 and in vasopressin group is 29. The significance level was 0.05 for all analyses. All tests were 2-sided. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-0.0035||||0.88|TWO_SIDED|95.0|-0.05|0.043|||Mixed Models Analysis|||mPAP-to-MAP ratio was compared between patients without pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension.||0.043|-0.05|0.88
74028205|NCT01380093|147610114|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.4998|TWO_SIDED|95.0|-1.0|2.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.0|-1.0|0.4998
74028206|NCT01380093|147610114|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0008|TWO_SIDED|95.0|1.1|4.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.2|1.1|0.0008
74028207|NCT01380093|147610115|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.0||||0.0009|TWO_SIDED|95.0|-11.1|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.0|-11.1|0.0009
74028208|NCT01380093|147610115|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.2693|TWO_SIDED|95.0|-1.8|6.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||6.3|-1.8|0.2693
74028209|NCT01380093|147610115|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.3|13.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||13.3|5.3|<0.0001
74028210|NCT01380093|147610116|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.2||||0.0042|TWO_SIDED|95.0|-27.2|-5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-5.3|-27.2|0.0042
74028211|NCT01380093|147610116|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.1139|TWO_SIDED|95.0|-2.2|19.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||19.6|-2.2|0.1139
73921903|NCT00546637|147371854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1595||95.0|0.0|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q1||0.3|-0.0|0.1595
74028212|NCT01380093|147610116|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0|||<|0.0001|TWO_SIDED|95.0|14.1|35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||35.9|14.1|<0.0001
73921904|NCT00546637|147371854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0614||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q2||0.0|-0.3|0.0614
73921905|NCT00546637|147371854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2032||95.0|-0.1|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q3||0.3|-0.1|0.2032
73921906|NCT00546637|147371854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0631||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q4||0.0|-0.3|0.0631
73921907|NCT00546637|147371854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9706||95.0|-0.2|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q5||0.2|-0.2|0.9706
73921908|NCT00546637|147371854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8058||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q6||0.2|-0.1|0.8058
73921909|NCT00546637|147371854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3302|TWO_SIDED|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q7||0.2|-0.1|0.3302
73921910|NCT00546637|147371855|SUPERIORITY_OR_OTHER|||||||0.1136||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.1136
73967586|NCT04501861|147472597|EQUIVALENCE|Imbalanced confounders such as female, coronary artery disease, preoperative ejection fraction, surgery type, primary or repeat surgery, and bypass time were additionally adjusted. A different inverse probability of treatment weighting was fit for secondary analysis and a linear mixed regression model with random intercept to account for intra-week correlation to estimate the effect of norepinephrine on right ventricular free wall strain using the new obtained stabilized weights|Mean Difference (Final Values)|-1.8||||0.37|TWO_SIDED|95.0|-6.0|2.3|||Mixed Models Analysis|||||2.3|-6.0|0.37
73971403|NCT04508309|147483471|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.09|||||TWO_SIDED|98.3|0.891|1.327|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||1.327|0.891|
74028213|NCT01380093|147610117|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.9|||<|0.0001|TWO_SIDED|95.0|-42.1|-27.7||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-27.7|-42.1|<0.0001
74028214|NCT01380093|147610117|SUPERIORITY_OR_OTHER||LS Mean Difference|27.2|||<|0.0001|TWO_SIDED|95.0|20.1|34.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.4|20.1|<0.0001
74028215|NCT01380093|147610117|SUPERIORITY_OR_OTHER||LS Mean Difference|62.1|||<|0.0001|TWO_SIDED|95.0|54.9|69.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||69.4|54.9|<0.0001
74028216|NCT01380093|147610118|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.1||||0.0039|TWO_SIDED|95.0|-58.5|-11.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.7|-58.5|0.0039
73921911|NCT00546637|147371856|SUPERIORITY_OR_OTHER|||||||0.5775||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.5775
73921912|NCT00546637|147371857|SUPERIORITY_OR_OTHER|||||||0.7433||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.7433
73921913|NCT00546637|147371858|SUPERIORITY_OR_OTHER|||||||0.9402||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.9402
73921914|NCT00546637|147371859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|0.9||0.004||95.0|-4.5|-0.9||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.9|-4.5|0.0040
73921915|NCT00546637|147371859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|1.0||0.0068||95.0|-4.8|-0.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||-0.8|-4.8|0.0068
73921916|NCT00546637|147371860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.9||0.0412||95.0|0.1|3.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||3.6|0.1|0.0412
73921917|NCT00546637|147371860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|1.0||0.1373||95.0|-0.5|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12||3.4|-0.5|0.1373
73921918|NCT00546637|147371861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.0||0.0941||95.0|-0.3|3.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4||3.8|-0.3|0.0941
73921919|NCT00546637|147371861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.1||0.2273||95.0|-0.8|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||3.4|-0.8|0.2273
73921920|NCT00546637|147371862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.1||0.0507||95.0|0.0|4.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||4.3|-0.0|0.0507
73921921|NCT00546637|147371862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.2||0.1136||95.0|-0.4|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12||4.1|-0.4|0.1136
73921922|NCT00546637|147371863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.1||0.0845||95.0|-0.3|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||4.1|-0.3|0.0845
73921923|NCT00546637|147371863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.2||0.0662||95.0|-0.2|4.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||4.6|-0.2|0.0662
73921924|NCT00546637|147371864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|0.9||0.1085||95.0|-0.3|3.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4||3.2|-0.3|0.1085
73921925|NCT00546637|147371864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.9||0.7685||95.0|-1.6|2.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||2.1|-1.6|0.7685
73921926|NCT00546637|147371865|SUPERIORITY_OR_OTHER||Median Difference (Net)|6.0||||0.0005||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.0005
73921927|NCT00546637|147371865|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.0|||<|0.0001||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 8||||<.0001
73921928|NCT00546637|147371865|SUPERIORITY_OR_OTHER||Median Difference (Net)|9.0||||0.0003||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.0003
74028217|NCT01380093|147610118|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3||||0.1026|TWO_SIDED|95.0|-4.0|42.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||42.7|-4.0|0.1026
74028218|NCT01380093|147610118|SUPERIORITY_OR_OTHER||LS Mean Difference|54.4|||<|0.0001|TWO_SIDED|95.0|31.0|77.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||77.8|31.0|<0.0001
73921929|NCT00546637|147371866|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.4||||0.2251||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|||||0.2251
73921930|NCT01074450|147371869|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.93|||||TWO_SIDED|90.0|94.23|108.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.1|94.23|
73921931|NCT01074450|147371870|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.71|||||TWO_SIDED|90.0|99.74|109.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.92|99.74|
73921932|NCT01074450|147371871|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.15|||||TWO_SIDED|90.0|99.05|109.52|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.52|99.05|
73921933|NCT00680745|147371872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.0867|<|0.0001|TWO_SIDED|95.0|-0.61|-0.27||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.27|-0.61|<0.0001
73921934|NCT00680745|147371872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.0885|<|0.0001|TWO_SIDED|95.0|-0.67|-0.32||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).||-0.32|-0.67|<0.0001
73921935|NCT00680745|147371872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.0873|<|0.0001|TWO_SIDED|95.0|-0.86|-0.51||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).||-0.51|-0.86|<0.0001
73921936|NCT00680745|147371873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.3153||0.141|TWO_SIDED|95.0|-1.08|0.15||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||0.15|-1.08|0.1410
74028219|NCT01380093|147610119|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.3||||0.0051|TWO_SIDED|95.0|-73.1|-13.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-13.5|-73.1|0.0051
74028220|NCT01380093|147610119|SUPERIORITY_OR_OTHER||LS Mean Difference|25.3||||0.0941|TWO_SIDED|95.0|-4.4|55.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||55.0|-4.4|0.0941
73921937|NCT00680745|147371873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.3217||0.0091|TWO_SIDED|95.0|-1.47|-0.21||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.21|-1.47|0.0091
73921938|NCT00680745|147371873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.3168|<|0.0001|TWO_SIDED|95.0|-2.17|-0.92||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.92|-2.17|<0.0001
73921939|NCT00680745|147371874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.5|STANDARD_ERROR_OF_MEAN|6.874|||TWO_SIDED|95.0|-45.0|-18.0||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-18.0|-45.0|
73931038|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.66|||<|0.001|TWO_SIDED|95.0|1.46|1.88|||cLDA model||V116/PPSV23|Serotype 20A: V116/PPSV23 GMT Ratio||1.88|1.46|<0.001
73931039|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.53|||<|0.001|TWO_SIDED|95.0|1.34|1.75|||cLDA model||V116/PPSV23|Serotype 22F: V116/PPSV23 GMT Ratio||1.75|1.34|<0.001
74028221|NCT01380093|147610119|SUPERIORITY_OR_OTHER||LS Mean Difference|68.6|||<|0.0001|TWO_SIDED|95.0|38.8|98.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||98.4|38.8|<0.0001
74028222|NCT01380093|147610120|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0||||0.0083|TWO_SIDED|95.0|-85.0|-13.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-13.1|-85.0|0.0083
74028223|NCT01380093|147610120|SUPERIORITY_OR_OTHER||LS Mean Difference|32.3||||0.0766|TWO_SIDED|95.0|-3.5|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||68.1|-3.5|0.0766
74028224|NCT01380093|147610120|SUPERIORITY_OR_OTHER||LS Mean Difference|81.3|||<|0.0001|TWO_SIDED|95.0|45.4|117.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||117.3|45.4|<0.0001
73931040|NCT05569954|147391863|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.76|1.04|||cLDA model||V116/PPSV23|Serotype 33F: V116/PPSV23 GMT Ratio||1.04|0.76|<0.001
74028225|NCT01380093|147610121|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.0||||0.0018|TWO_SIDED|95.0|-12.9|-3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.1|-12.9|0.0018
74028226|NCT01380093|147610121|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8||||0.0527|TWO_SIDED|95.0|-0.1|9.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||9.7|-0.1|0.0527
74028227|NCT01380093|147610121|SUPERIORITY_OR_OTHER||LS Mean Difference|12.8|||<|0.0001|TWO_SIDED|95.0|7.9|17.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17.7|7.9|<0.0001
74086784|NCT02688387|147727477|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9612|||||TWO_SIDED|90.0|0.9265|0.9972|||||X1 Vs R1, tadalafil|||0.9972|0.9265|
74086785|NCT02688387|147727477|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0122|||||TWO_SIDED|90.0|0.9562|1.0715|||||X2 Vs R2, tadalafil|||1.0715|0.9562|
73921940|NCT00680745|147371874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0|STANDARD_ERROR_OF_MEAN|6.968||0.0002|TWO_SIDED|95.0|-39.7|-12.3||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-12.3|-39.7|0.0002
73921941|NCT00680745|147371874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.9|STANDARD_ERROR_OF_MEAN|6.77|<|0.0001|TWO_SIDED|95.0|-42.2|-15.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-15.6|-42.2|<0.0001
73921942|NCT00680745|147371875|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.7|STANDARD_ERROR_OF_MEAN|4.265|||TWO_SIDED|95.0|5.4|22.1||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||22.1|5.4|
73921943|NCT00680745|147371875|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.3|STANDARD_ERROR_OF_MEAN|4.392||0.0001|TWO_SIDED|95.0|8.7|25.9||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||25.9|8.7|0.0001
73921944|NCT00680745|147371875|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|4.457|<|0.0001|TWO_SIDED|95.0|9.9|27.4||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||27.4|9.9|<0.0001
73921945|NCT00680745|147371876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.4159|||TWO_SIDED|95.0|-1.19|0.45||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||0.45|-1.19|
73921946|NCT00680745|147371876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.4234||0.0262|TWO_SIDED|95.0|-1.78|-0.11||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.11|-1.78|0.0262
74028228|NCT01380093|147610122|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.3986|TWO_SIDED|95.0|-1.4|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.6|-1.4|0.3986
74028229|NCT01380093|147610122|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.0023|TWO_SIDED|95.0|0.6|2.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.5|0.6|0.0023
74028230|NCT01380093|147610122|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.0002|TWO_SIDED|95.0|1.0|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.9|1.0|0.0002
74086786|NCT02688387|147727478|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0153|||||TWO_SIDED|90.0|0.9348|1.1027|||||Y1 Vs R3, ambrisentan|||1.1027|0.9348|
74086787|NCT02688387|147727478|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9758|||||TWO_SIDED|90.0|0.9044|1.0529|||||Y1 Vs R3, tadalafil|||1.0529|0.9044|
73921947|NCT00680745|147371876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.4211|<|0.0001|TWO_SIDED|98.0|-2.5|-0.84||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.84|-2.50|<0.0001
73967587|NCT04501861|147472597|EQUIVALENCE|We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by considering patients who have preoperative pulmonary hypertension. The number of patients in norepinephrine group is 34 and in vasopressin group is 28. The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-2.1||||0.39|TWO_SIDED|95.0|-7.1|2.8|||Mixed Models Analysis|||RV free wall strain compare between patients with pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension;||2.8|-7.1|0.39
73967588|NCT04501861|147472597|EQUIVALENCE|We're going to explore the interaction between preoperative pulmonary arterial hypertension status and treatment group by equivalence analysis. The number of patients in norepinephrine group is 22 and in vasopressin group is 18.The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-1.5||||0.63|TWO_SIDED|95.0|-7.6|4.6|||Mixed Models Analysis|||"We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by separately considering patients who did not have preoperative pulmonary hypertension.~Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension."||4.6|-7.6|0.63
73967589|NCT01007591|147472631|SUPERIORITY||Mean Difference (Final Values)|-6.02||||0.75|TWO_SIDED|95.0|-43.7|31.7|||ANOVA|Treatment comparison using an ANOVA model with age group and treatment as design variables.||||31.7|-43.7|0.75
73967590|NCT04083235|147472636|OTHER||Hazard Ratio (HR)|0.83||||0.04|TWO_SIDED|95.0|0.7|0.99|||Stratified log-rank test||The HR and 95% confidence interval (CI) was based on a stratified Cox proportional hazards regression model, stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status, region and liver metastases as per IWRS.|||0.99|0.70|0.04
73967591|NCT04083235|147472637|OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.83|||Stratified log-rank test||The HR and 95% CI was based on a stratified Cox proportional hazards regression model, stratified by baseline ECOG performance status, region and liver metastases as per IWRS.|||0.83|0.58|<0.0001
74028231|NCT01380093|147610123|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.2||||0.0029|TWO_SIDED|95.0|-18.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4|-18|0.0029
74028232|NCT01380093|147610123|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1||||0.0286|TWO_SIDED|95.0|1.0|15.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||15|1|0.0286
73921948|NCT00680745|147371877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|3.522|||TWO_SIDED|95.0|-21.8|-7.9||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-7.9|-21.8|
73921949|NCT00680745|147371877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|STANDARD_ERROR_OF_MEAN|3.594|<|0.0001|TWO_SIDED|95.0|-26.3|-12.2||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-12.2|-26.3|<0.0001
73921950|NCT00680745|147371877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.5|STANDARD_ERROR_OF_MEAN|3.545|<|0.0001|TWO_SIDED|95.0|-33.5|-19.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-19.5|-33.5|<0.0001
73921951|NCT02612428|147371878|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.762|TWO_SIDED|95.0|0.509|1.64|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.||1.640|0.509|0.762
73921952|NCT02612428|147371879|SUPERIORITY|||||||0.6829|||||||Chi-squared|||||||0.6829
73921953|NCT02612428|147371880|SUPERIORITY|||||||0.048|||||||Chi-squared|||||||0.048
73921954|NCT00137423|147371884|SUPERIORITY_OR_OTHER||Objective Response Rate|28.3||||||95.0|16.8|42.3|||F distribution|||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was \<=5% versus alternative hypothesis that true response rate was \>=15% with 90% power and alpha level of 0.05. If number of OR\> =11 null hypothesis that true response rate was \<=5% could be rejected with a target α error rate of 0.05.||42.3|16.8|
74028233|NCT01380093|147610123|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|||<|0.0001|TWO_SIDED|95.0|12.0|27.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||27|12|<0.0001
74086788|NCT02688387|147727479|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.039|||||TWO_SIDED|90.0|1.0168|1.0617|||||Y1 Vs R3, ambrisentan|||1.0617|1.0168|
73861564|NCT02699450|147269021|SUPERIORITY||Difference in Least Squares Means|9.5||||0.27|TWO_SIDED|80.0|-1.6|20.6||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||20.6|-1.6|0.27
73861565|NCT02699450|147269021|SUPERIORITY||Difference in Least Squares Means|6.8||||0.45|TWO_SIDED|80.0|-4.9|18.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||18.5|-4.9|0.45
73921955|NCT00137423|147371884|SUPERIORITY_OR_OTHER||Objective Response Rate|11.5||||||95.0|4.4|23.4|||F distribution|||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was \<=5% versus alternative hypothesis that true response rate was \>=15% with 90% power and alpha level of 0.05. If number of OR\> =11 null hypothesis that true response rate was \<=5% could be rejected with a target α error rate of 0.05.||23.4|4.4|
73921956|NCT00137423|147371888|SUPERIORITY_OR_OTHER||1-year survival rate|77.4||||||95.0|63.6|86.5|||Kaplan-Meier method||valid presentation only if at least 1 patient has overall survival \>=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.|||86.5|63.6|
73921957|NCT00137423|147371888|SUPERIORITY_OR_OTHER||1-year survival rate|66.0||||||95.0|51.6|77.1|||Kaplan-Meier method||valid presentation only if at least 1 patient has overall survival \>=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.|||77.1|51.6|
73921958|NCT01928329|147371892|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.0816|TWO_SIDED|95.0|-0.5|0.03||The \<0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).||||0.03|-0.50|0.0816
73921959|NCT01928329|147371893|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.912|TWO_SIDED|95.0|-0.28|0.25||The \<0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).||||0.25|-0.28|0.912
73967592|NCT04083235|147472638|OTHER||Odds Ratio (OR)|1.26||||0.11|TWO_SIDED|95.0|0.95|1.69|||Cochran-Mantel-Haenszel||OR, 95% CI and p-value were obtained from the Cochran-Mantel-Haenszel test adjusting by baseline ECOG performance status, region and liver metastases as per IWRS.|||1.69|0.95|0.11
73967593|NCT01804816|147472654|EQUIVALENCE|a=0.05||||||0.063|||||||t-test, 2 sided|||||||0.063
74028234|NCT01380093|147610124|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.0||||0.005|TWO_SIDED|95.0|-22.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4|-22|0.0050
74028235|NCT01380093|147610124|SUPERIORITY_OR_OTHER||LS Mean Difference|8.2||||0.07|TWO_SIDED|95.0|-1.0|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17|-1|0.0700
73921960|NCT01928329|147371894|SUPERIORITY||Z score|-0.801||||0.423|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.423
73921961|NCT01928329|147371895|SUPERIORITY||Z score|-1.312||||0.189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.189
73967594|NCT01804816|147472655|EQUIVALENCE|a = 0.05||||||0.005|||||||t-test, 2 sided|||Based on results from prior small clinical trials we estimate the need for 20 patients enrolled to reach 80% statistical power.||||0.005
73967595|NCT01804816|147472655|EQUIVALENCE|a=0.05||||||0.002|||||||t-test, 2 sided|||||||0.002
73967596|NCT01804816|147472655|EQUIVALENCE|a=0.05||||||0.441|||||||t-test, 2 sided|||||||0.441
73967597|NCT01804816|147472656|EQUIVALENCE|a=0.05||||||0.729|||||||t-test, 2 sided|||||||0.729
74028236|NCT01380093|147610124|SUPERIORITY_OR_OTHER||LS Mean Difference|21.2|||<|0.0001|TWO_SIDED|95.0|12.0|30.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||30|12|<0.0001
74028237|NCT01380093|147610125|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.5|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.9|0.5|<0.0001
74028238|NCT01380093|147610125|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.3|-0.8|<0.0001
74028239|NCT01380093|147610125|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.0|-1.5|<0.0001
74028240|NCT01380093|147610126|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|||<|0.0001|TWO_SIDED|95.0|1.9|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.9|1.9|<0.0001
74028241|NCT01380093|147610126|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.3|-2.2|<0.0001
73921962|NCT01341964|147371911|SUPERIORITY||Median Difference (Final Values)|0.05||||0.66|TWO_SIDED||||||t-test, 2 sided|not normally distributed, values were log-transformed.||||||0.66
73921963|NCT01516424|147371914|NON_INFERIORITY_OR_EQUIVALENCE|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|3.69|||<|0.05|TWO_SIDED|95.0|-0.36|7.75||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is ITT analysis data.|"ANCOVA was employed to compare the changes of PANSS scores at week 8 relative to the baseline in these 2 groups. Least Squares Means for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone\> 7.0)."||7.75|-0.36|<0.05
73921964|NCT01516424|147371914|NON_INFERIORITY_OR_EQUIVALENCE|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|2.94|||<|0.05|TWO_SIDED|95.0|-0.76|6.65||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is PPS analysis data.|"ANCOVA was employed to compare the changes of PANSS total scores at end of treatment relative to the baseline in these 2 groups. LSMeans for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone\> 7.0)."||6.65|-0.76|<0.05
73921965|NCT00597766|147371919|SUPERIORITY_OR_OTHER||GroupXtime interaction|-0.17||||0.16|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,92)=2.06, p=0.16|Linear mixed model|1st order antedependence covariance structure||"Hypothesis that 60mg group would have greater pain relief than the the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."||||0.16
73921966|NCT00597766|147371919|SUPERIORITY_OR_OTHER||group x time interaction|-0.04||||0.77|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,90)=0.1, p=0.77|linear mixed model|first order antedependent covariance structure||"Hypothesis that 40mg group would have greater pain reduction than the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."||||0.77
73921967|NCT00597766|147371920|SUPERIORITY_OR_OTHER||group x time interaction|-0.3||||0.2|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.7, p=0.2|Linear mixed model|first order antedpendent covariance structure||This study was not powered for secondary outcomes. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.2
73921968|NCT00597766|147371920|SUPERIORITY_OR_OTHER||group x time interaction|-0.02||||0.9|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=0.0, p=0.9|linear mixed model|1st order antedependence covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.9
73921969|NCT00597766|147371921|SUPERIORITY_OR_OTHER||Groupxtime interaction|1.3||||0.2|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.6, p=0.2|linear mixed model|unstructured covariance structure||The study was not powered for secondary analyses. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.2
73921970|NCT00597766|147371921|SUPERIORITY_OR_OTHER||Groupxtime interaction|1.1||||0.3|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.0, p=0.3|linear mixed model|Unstructured covariance structure||Secondary outcomes were not powered for analysis. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.3
73967598|NCT03400059|147472658|SUPERIORITY||Mean Difference (Final Values)|-2.23||||0.0132|TWO_SIDED|95.0|-4.11|-0.49||"analysis of covariance (ANCOVA) model containing terms for treatment, baseline value and medication overuse.~Group-sequential analysis using updated boundaries from interim analysis"|ANCOVA|||||-0.49|-4.11|0.0132
73967599|NCT03400059|147472659|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0014|TWO_SIDED|95.0|-4.32|-1.04|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse||||-1.04|-4.32|0.0014
73967600|NCT03400059|147472660|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.0048|TWO_SIDED|95.0|-4.06|-0.73|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse||||-0.73|-4.06|0.0048
73967601|NCT03400059|147472661|SUPERIORITY||Mean Difference (Final Values)|-2.87||||0.0008|TWO_SIDED|95.0|-4.54|-1.2|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||-1.20|-4.54|0.0008
73967602|NCT03400059|147472662|SUPERIORITY||Mean Difference (Final Values)|-1.53||||0.0598|TWO_SIDED|95.0|-3.12|0.06|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||0.06|-3.12|0.0598
73921971|NCT00597766|147371922|SUPERIORITY_OR_OTHER||group x time interaction|0.4||||0.8|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=0.06, p=0.8|linear mixed model|first order antedepentent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.8
73921972|NCT00597766|147371922|SUPERIORITY_OR_OTHER||group x time interaction|1.7||||0.3|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.1, p=0.3|linear mixed model|first order antedependent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.3
73921973|NCT00840294|147371943|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
73921974|NCT01340898|147371984|SUPERIORITY_OR_OTHER||Percentage of subjects|100.0|||||TWO_SIDED|95.0|98.9|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup A one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||100|98.9|
73921975|NCT01340898|147371984|SUPERIORITY_OR_OTHER||Percentage of subjects|99.7|||||TWO_SIDED|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup C one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants.||100|98.3|
73921976|NCT01340898|147371984|SUPERIORITY_OR_OTHER||Percentage of subjects|99.4|||||TWO_SIDED|95.0|97.8|99.9|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup W-135 one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||99.9|97.8|
73921977|NCT01340898|147371984|SUPERIORITY_OR_OTHER||Percentage of subjects|99.7|||||TWO_SIDED|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup Y one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||100|98.3|
73921978|NCT04501666|147372031|SUPERIORITY||Strata adjusted percentage difference|40.1|||<|0.0001|TWO_SIDED|95.0|29.4|50.8||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||50.8|29.4|< 0.0001
73921979|NCT04501666|147372032|SUPERIORITY||Strata adjusted percentage difference|14.6||||0.0025|TWO_SIDED|95.0|6.7|22.6||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||22.6|6.7|0.0025
73921980|NCT04501666|147372034|SUPERIORITY||Strata adjusted percentage difference|31.7|||<|0.0001|TWO_SIDED|95.0|23.0|40.4||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||40.4|23.0|< 0.0001
73921981|NCT04501666|147372035|SUPERIORITY||Strata adjusted percentage difference|30.5|||<|0.0001|TWO_SIDED|95.0|22.3|38.7||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.7|22.3|< 0.0001
73921982|NCT04501666|147372036|SUPERIORITY||Strata adjusted percentage difference|38.0|||<|0.0001|TWO_SIDED|95.0|27.8|48.2||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||48.2|27.8|< 0.0001
73931041|NCT05569954|147391863|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|3.31|||<|0.001|TWO_SIDED|95.0|2.84|3.87||1-sided|cLDA model||V116/PPSV23|Serotype 6A: V116/PPSV23 GMT Ratio||3.87|2.84|<0.001
74086789|NCT02688387|147727479|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9806|||||TWO_SIDED|90.0|0.9106|1.056|||||Y1 Vs R3, tadalafil|||1.0560|0.9106|
73921983|NCT04501666|147372037|SUPERIORITY||Strata adjusted percentage difference|22.7|||<|0.0001|TWO_SIDED|95.0|14.7|30.7||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||30.7|14.7|< 0.0001
73921984|NCT04501666|147372038|SUPERIORITY||Strata adjusted percentage difference|18.7|||<|0.0001|TWO_SIDED|95.0|12.3|25.0||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||25.0|12.3|< 0.0001
73921985|NCT01338493|147372055|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73921986|NCT01338493|147372056|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73921987|NCT00056407|147372070|SUPERIORITY_OR_OTHER||Relative Risk Reduction|23.3|||<|0.0001||95.0|15.6|30.3||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data given are for the overall assessment.|||30.3|15.6|<0.0001
73921988|NCT00056407|147372071|SUPERIORITY_OR_OTHER||Relative Risk Reduction|23.1|||<|0.0001||95.0|15.5|30.0||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data are given are for the overall assessment.|||30.0|15.5|<0.0001
73921989|NCT00056407|147372072|SUPERIORITY_OR_OTHER||Relative Risk Reduction|22.8|||<|0.0001||95.0|15.2|29.8||The p value is given for the overall assessment.|Mantel-Cox||Estimation data are given for the overall assessment.|||29.8|15.2|<0.0001
73921990|NCT00056407|147372095|SUPERIORITY_OR_OTHER||Difference in adjusted means|18.8|||<|0.001||95.0|17.3|20.4|||general linear model, t-test||The adjusted mean difference was calculated as the difference between the adjusted means (-6.1 and 12.7) for the placebo and Dutasteride arms, respectively.|||20.4|17.3|<0.001
73921991|NCT00319644|147372107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0||||0.26||95.0|||||Chi-squared|||The chi-square test(or Fisher exact test where needed) was used to compare proportions with dichotomous variables. The Student-t test was used for quantitative variables woth normal distribution, and Mann-Whitney-U test was used for data not normally distributed.||||0.26
73921992|NCT00786487|147372239|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73967603|NCT03400059|147472663|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.031|TWO_SIDED|95.0|-3.63|-0.17|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||-0.17|-3.63|0.0310
73967604|NCT03400059|147472664|SUPERIORITY|||||||0.0102|||||||Chi-squared|||||||0.0102
73921993|NCT00786487|147372239|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73921994|NCT00605813|147372296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."||||0.003
73921995|NCT00605813|147372297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||<0.001
73967605|NCT03400059|147472665|SUPERIORITY|||||||0.1615|||||||Chi-squared|||||||0.1615
73921996|NCT00605813|147372298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with or without non-pharmaceutical therapies in the participants of responders."||||0.040
73921997|NCT00605813|147372299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was present or past history of intentional suicidal ideation. The null hypothesis is there is no difference between present or past history of intentional suicidal ideation (including suicide attempt) in the participants of responders."||||0.004
73921998|NCT02493608|147372332|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73921999|NCT02493608|147372333|OTHER|||||||0.218||||||POD 1|t-test, 2 sided|||||||0.218
73922000|NCT02493608|147372333|OTHER|||||||0.638||||||POD 2|t-test, 2 sided|||||||0.638
73922001|NCT02493608|147372334|OTHER|||||||0.113|||||||t-test, 2 sided|||||||0.113
73922002|NCT00174915|147372335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL versus \[v.\] \>1.5 mg/dL).||||||<0.001
73922003|NCT00174915|147372335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73967606|NCT03400059|147472666|SUPERIORITY|||||||0.0798|||||||Chi-squared|||||||0.0798
73967607|NCT03400059|147472667|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.1300
73967608|NCT03400059|147472668|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.066|TWO_SIDED|||||posthoc|Van-Elteren|||||||0.0660
73967609|NCT03400059|147472669|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.0152|TWO_SIDED|||||posthoc|Van-Elteren|||||||0.0152
73967610|NCT04638829|147472713|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
73967611|NCT04638829|147472714|OTHER|||||||0.0093|||||||t-test, 2 sided|||||||0.0093
73967612|NCT04638829|147472715|OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
73967613|NCT04638829|147472716|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73967614|NCT02807636|147472739|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0073|TWO_SIDED|95.0|0.7|0.96||inverse normal combination|Log Rank|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||0.96|0.70|0.0073
73967615|NCT02807636|147472740|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.023|TWO_SIDED|95.0|0.73|1.0||one-sided, inverse normal combination|Regression, Cox|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.0|0.73|0.0230
73967616|NCT02807636|147472741|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.3968|TWO_SIDED|95.0|0.82|1.16|||Log Rank|one-sided||Stratification factors: PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.16|0.82|0.3968
73967617|NCT02807636|147472746|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0373|TWO_SIDED|95.0|0.73|1.01||inverse normal combination|Regression, Cox|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.01|0.73|0.0373
73967618|NCT02807636|147472747|SUPERIORITY||Difference in Event Free Rate|5.0||||0.1509|TWO_SIDED|95.0|-1.82|11.81|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||11.81|-1.82|0.1509
73967619|NCT02807636|147472748|SUPERIORITY||Difference in Event Free Rate|3.36||||0.3761|TWO_SIDED|95.0|-4.08|10.79|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||10.79|-4.08|0.3761
73967620|NCT02807636|147472749|SUPERIORITY||Difference in Event Free Rate|-8.29||||0.0083|TWO_SIDED|95.0|-14.45|-2.13|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||-2.13|-14.45|0.0083
73967621|NCT02807636|147472750|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0542|TWO_SIDED|95.0|0.64|1.0|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.00|0.64|0.0542
73967622|NCT02807636|147472751|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6139|TWO_SIDED|95.0|0.74|1.19|||Log Rank|||Strata are: PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.19|0.74|0.6139
74028242|NCT01380093|147610126|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|||<|0.0001|TWO_SIDED|95.0|-4.6|-3.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.6|-4.6|<0.0001
73922004|NCT00174915|147372335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922005|NCT00174915|147372335|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|25.7||||||97.5|16.7|34.7||||||||34.7|16.7|
73967623|NCT02807636|147472752|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.554|TWO_SIDED|95.0|0.86|1.32|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.32|0.86|0.5540
74028243|NCT01380093|147610127|SUPERIORITY_OR_OTHER||LS Mean Difference|4.9|||<|0.0001|TWO_SIDED|95.0|3.9|5.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.8|3.9|<0.0001
73967624|NCT02807636|147472753|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.0241|TWO_SIDED|95.0|1.03|1.62|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.62|1.03|0.0241
73967625|NCT02807636|147472757|SUPERIORITY||Hazard Ratio (HR)|1.42||||1|TWO_SIDED|95.0|1.19|1.69|||Log Rank|||Stratification factors: PD-L1 status and Bajorin risk score/presence of liver metastases and investigator choice of chemotherapy.||1.69|1.19|1.0000
73967626|NCT04088630|147472767|SUPERIORITY|||||||0.0427||||||p\<0.05 considered significant. Between group pairwise comparisons performed with Bonferroni correction.|Fisher Exact|||Difference in proportion of subjects with cardiac events up to 30 days post-ictus tested between three groups.||||0.0427
73967627|NCT04088630|147472768|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Difference in proportion of subjects with nosocomial infections up to 90 days post-ictus tested between three groups. No pairwise comparisons performed.||||0.19
73967628|NCT04088630|147472769|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Difference in proportion of subjects with neurologic decline up to 30 days post-ictus tested between three groups. No pairwise comparisons performed.||||0.30
74028244|NCT01380093|147610127|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|||<|0.0001|TWO_SIDED|95.0|-6.3|-4.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4.3|-6.3|<0.0001
74028245|NCT01380093|147610127|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.1|||<|0.0001|TWO_SIDED|95.0|-11.1|-9.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.2|-11.1|<0.0001
73967629|NCT03381261|147472806|OTHER|While descriptive statistics were presented in the original mRNA units using median and interquartile range (25th, 75th), statistical group comparison and effect sizes were reported as the ratio of the geometric means.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73967630|NCT05634226|147472807|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
73967631|NCT05634226|147472808|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
73967632|NCT05493423|147472814|NON_INFERIORITY|The null hypothesis is that the difference between the rates of completed hemodialysis sessions for the test and control groups is less than or equal to the non-inferiority margin (indicating inferior success rate). Rejection of the null hypothesis indicates the data supports the alternative hypothesis that the difference between the rates of successfully completed HD sessions for the test and control groups is at least the non-inferiority margin (indicating non-inferior success rate).||||||0.008|||||||Farrington-Manning|non-inferiority margin = 0.08||||||.008
73967633|NCT05493423|147472814|EQUIVALENCE|non-inferiority margin = 0.08||||||0.002|||||||Equivalence Test with paired data|||||||.002
73967634|NCT05493423|147472815|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
73967635|NCT05493423|147472816|SUPERIORITY|||||||0.84||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.84
73967636|NCT05493423|147472817|SUPERIORITY|||||||0.132|||||||t-test, 2 sided|||||||0.132
73967637|NCT05493423|147472818|SUPERIORITY|||||||0.84||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.84
74086790|NCT02688387|147727480|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0365|||||TWO_SIDED|90.0|1.0138|1.0596|||||Y1 Vs R3, ambrisentan|||1.0596|1.0138|
74086791|NCT02688387|147727480|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9821|||||TWO_SIDED|90.0|0.9145|1.0547|||||Y1 Vs R3, tadalafil|||1.0547|0.9145|
74086792|NCT02688387|147727481|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1176|||||TWO_SIDED|90.0|1.0166|1.2287|||||Y2 Vs R4, ambrisentan|||1.2287|1.0166|
73967638|NCT05493423|147472819|SUPERIORITY|||||||0.197||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.197
73967639|NCT05493423|147472820|SUPERIORITY|||||||0.424|||||||t-test, 2 sided|||||||0.424
74028246|NCT01380093|147610128|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6|||<|0.0001|TWO_SIDED|95.0|6.6|10.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||10.7|6.6|<0.0001
74028247|NCT01380093|147610128|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.8|||<|0.0001|TWO_SIDED|95.0|-15.9|-11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.8|-15.9|<0.0001
74028248|NCT01380093|147610128|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|95.0|-24.5|-20.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-20.4|-24.5|<0.0001
74028249|NCT01380093|147610129|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7|||<|0.0001|TWO_SIDED|95.0|8.7|14.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||14.7|8.7|<0.0001
74028250|NCT01380093|147610129|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|||<|0.0001|TWO_SIDED|95.0|-24.5|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.6|-24.5|<0.0001
74028251|NCT01380093|147610129|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.2|||<|0.0001|TWO_SIDED|95.0|-36.2|-30.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-30.2|-36.2|<0.0001
74028252|NCT01380093|147610130|SUPERIORITY_OR_OTHER||LS Mean Difference|17.5|||<|0.0001|TWO_SIDED|95.0|11.6|23.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||23.3|11.6|<0.0001
74028253|NCT01380093|147610130|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.7|||<|0.0001|TWO_SIDED|95.0|-43.6|-31.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-31.9|-43.6|<0.0001
73967640|NCT05493423|147472821|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
73967641|NCT05493423|147472822|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to as 0 by the statistical software.|t-test, 2 sided|||||||0
73967642|NCT05493423|147472823|SUPERIORITY|||||||0.57||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.57
73967643|NCT05493423|147472824|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
73861566|NCT02699450|147269022|SUPERIORITY||Difference in Least Squares Means|-0.6||||0.96|TWO_SIDED|80.0|-16.8|15.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||15.5|-16.8|0.96
73861567|NCT02699450|147269023|SUPERIORITY||Difference in Least Squares Means|9.9||||0.19|TWO_SIDED|80.0|0.1|19.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||19.7|0.1|0.19
73861568|NCT02699450|147269023|SUPERIORITY||Difference in Least Squares Means|4.2||||0.57|TWO_SIDED|80.0|-5.3|13.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||13.6|-5.3|0.57
73861569|NCT02699450|147269024|SUPERIORITY||Difference in Least Squares Means|-2.8||||0.64|TWO_SIDED|80.0|-10.5|4.9||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.9|-10.5|0.64
73861570|NCT02699450|147269024|SUPERIORITY||Difference in Least Squares Means|-1.8||||0.78|TWO_SIDED|80.0|-9.8|6.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||6.2|-9.8|0.78
73861571|NCT02699450|147269025|SUPERIORITY||Difference in Least Squares Means|-2.3||||0.78|TWO_SIDED|80.0|-12.7|8.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||8.2|-12.7|0.78
73861572|NCT02699450|147269026|SUPERIORITY||Difference in Least Squares Means|-0.5||||0.93|TWO_SIDED|80.0|-7.7|6.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||6.7|-7.7|0.93
73861573|NCT02699450|147269026|SUPERIORITY||Difference in Least Squares Means|-2.0||||0.69|TWO_SIDED|80.0|-8.3|4.4||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.4|-8.3|0.69
73861574|NCT02699450|147269027|SUPERIORITY||Difference in Least Squares Means|-6.5||||0.69|TWO_SIDED|80.0|-27.8|14.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||14.7|-27.8|0.69
73922006|NCT00174915|147372335|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|42.7||||||97.5|34.0|51.3||||||||51.3|34.0|
73922007|NCT00174915|147372335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922008|NCT00174915|147372335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922009|NCT00174915|147372335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73967644|NCT05493423|147472825|SUPERIORITY|||||||0.211|||||||t-test, 2 sided|||||||0.211
73967645|NCT05493423|147472826|SUPERIORITY|||||||0.804||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.804
73967646|NCT05493423|147472827|SUPERIORITY|||||||0.307||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.307
73967647|NCT05493423|147472828|SUPERIORITY|||||||0.315||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.315
73967648|NCT05285618|147472842|OTHER|A linear mixed model accounted for repeated measures ('subject\_id' as a random factor). No power calculation was performed, but the sample size (1,485 observations, 6 subjects) supports robust estimation.||||||0.002||||||P-values are unadjusted for multiple comparisons, as the analysis focused on a limited number of predictors. The a priori threshold for statistical significance was set at p\<0.05.|Mixed Models Analysis|||The model tested whether stimulation delay ('abs\_delay'), retinal distance ('dist\_ret'), and their interaction ('abs\_delay:dist\_ret') affect the number of elicited phosphenes ('num\_phosphenes').|We hypothesize that the parameter 'dist\_ret' may influence the number of phosphenes perceived ('num\_phosphenes'), while the roles of 'abs\_delay' and its interaction with 'dist\_ret' may be less pronounced. Further evaluation of these parameters will be conducted in the Results section|||0.002
73967649|NCT03892616|147472858|OTHER||Ratio of adjusted geometric means [%]|97.4|||||TWO_SIDED|90.0|82.3|115.3|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||115.3|82.3|
73967650|NCT03892616|147472858|OTHER||Ratio of adjusted geometric means [%]|183.0|||||TWO_SIDED|90.0|154.0|217.4|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||217.4|154.0|
73967651|NCT03892616|147472858|OTHER||Ratio of adjusted geometric means [%]|114.8|||||TWO_SIDED|90.0|96.5|136.6|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||136.6|96.5|
73967652|NCT03892616|147472858|OTHER||Ratio of adjusted geometric means [%]|66.5|||||TWO_SIDED|90.0|55.5|79.5|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||79.5|55.5|
73967653|NCT03892616|147472859|OTHER||Ratio of adjusted geometric means [%]|60.2|||||TWO_SIDED|90.0|55.3|65.5|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||65.5|55.3|
73967654|NCT03892616|147472859|OTHER||Ratio of adjusted geometric means [%]|71.5|||||TWO_SIDED|90.0|65.6|78.0|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||78.0|65.6|
73967655|NCT03892616|147472859|OTHER||Ratio of adjusted geometric means [%]|177.9|||||TWO_SIDED|90.0|162.8|194.3|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||194.3|162.8|
73922010|NCT00174915|147372335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
74028254|NCT01380093|147610130|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|95.0|-61.1|-49.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-49.3|-61.1|<0.0001
74028255|NCT01380093|147610131|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||<|0.0001|TWO_SIDED|95.0|0.8|1.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.4|0.8|<0.0001
73861575|NCT02699450|147269027|SUPERIORITY||Difference in Least Squares Means|-22.8||||0.18|TWO_SIDED|80.0|-44.5|-1.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-1.2|-44.5|0.18
73922011|NCT00174915|147372335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922012|NCT00174915|147372335|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.479
73922013|NCT00174915|147372335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922014|NCT00174915|147372336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922015|NCT00174915|147372336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922016|NCT00174915|147372336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922017|NCT00174915|147372336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922018|NCT00174915|147372336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922019|NCT00174915|147372336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
74086793|NCT02688387|147727481|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1196|||||TWO_SIDED|90.0|1.0429|1.2019|||||Y2 Vs R4, tadalafil|||1.2019|1.0429|
73922020|NCT00174915|147372336|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.011
73922021|NCT00174915|147372336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922022|NCT00174915|147372336|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.091
73922023|NCT00174915|147372336|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922024|NCT00174915|147372337|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922025|NCT00174915|147372337|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922026|NCT00174915|147372337|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922027|NCT00174915|147372337|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922028|NCT00174915|147372337|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
74086794|NCT02688387|147727482|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0353|||||TWO_SIDED|90.0|1.0009|1.071|||||Y2 Vs R4, ambrisentan|||1.0710|1.0009|
73922029|NCT00174915|147372337|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
74028256|NCT01380093|147610131|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.5|-2.1|<0.0001
73861576|NCT02699450|147269028|SUPERIORITY||Difference in Least Squares Means|-49.2||||0.07|TWO_SIDED|80.0|-84.2|-14.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||-14.2|-84.2|0.07
73861577|NCT02699450|147269029|SUPERIORITY||Difference in Least Squares Means|-17.3||||0.28|TWO_SIDED|80.0|-38.0|3.4||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.4|-38.0|0.28
73861578|NCT02699450|147269029|SUPERIORITY||Difference in Least Squares Means|-29.2||||0.05|TWO_SIDED|80.0|-47.8|-10.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-10.6|-47.8|0.05
73922030|NCT00174915|147372337|SUPERIORITY_OR_OTHER|||||||0.074||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.074
73922031|NCT00174915|147372337|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922032|NCT00174915|147372337|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.001
74028257|NCT01380093|147610131|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.2|-2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-2.6|-3.2|<0.0001
73922033|NCT00174915|147372337|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
73922034|NCT00174915|147372338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922035|NCT00174915|147372338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922036|NCT00174915|147372338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922037|NCT00174915|147372338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922038|NCT00174915|147372338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
74028258|NCT01380093|147610132|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5||||0.0262|TWO_SIDED|95.0|0.3|4.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.6|0.3|0.0262
74028259|NCT01380093|147610132|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.418|TWO_SIDED|95.0|-1.3|3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.0|-1.3|0.4180
73922039|NCT00174915|147372338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922040|NCT00174915|147372338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922041|NCT00174915|147372338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
74086795|NCT02688387|147727482|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0362|||||TWO_SIDED|90.0|0.991|1.0834|||||Y2 Vs R4, tadalafil|||1.0834|0.9910|
73922042|NCT00174915|147372338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922043|NCT00174915|147372338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
74028260|NCT01380093|147610132|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.1479|TWO_SIDED|95.0|-3.7|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.6|-3.7|0.1479
74086796|NCT02688387|147727483|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0351|||||TWO_SIDED|90.0|1.0002|1.0713|||||Y2 Vs R4, ambrisentan|||1.0713|1.0002|
74086797|NCT02688387|147727483|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0324|||||TWO_SIDED|90.0|0.9929|1.0734|||||Y2 Vs R4, tadalafil|||1.0734|0.9929|
74086798|NCT01115855|147727535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.36||||||Cox Proportional Hazard Model with baseline New York Heart Association (NYHA) cohort (II, III/IV) and baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) covariates.||1.36|0.53|
74086799|NCT01115855|147727536|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.56|1.31||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.31|0.56|
74086800|NCT01115855|147727537|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.77|||||TWO_SIDED|95.0|0.81|3.87||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||3.87|0.81|
74086801|NCT01115855|147727538|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.4|||||TWO_SIDED|95.0|0.92|6.24||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||6.24|0.92|
74086802|NCT01115855|147727539|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.44|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||0.97|0.44|
74086803|NCT01115855|147727540|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.45|1.25||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.25|0.45|
74086804|NCT01115855|147727541|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.45|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||0.97|0.45|
74086805|NCT01115855|147727542|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.49|1.33||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>=-50 ml/min/1.73 m\^2) covariates.||1.33|0.49|
74086806|NCT01115855|147727543|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.45|1.1||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.10|0.45|
74086807|NCT01115855|147727544|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.53|1.28||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.28|0.53|
74086808|NCT01115855|147727545|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.18|3.53||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||3.53|0.18|
73922044|NCT00174915|147372339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922045|NCT00174915|147372339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
74028261|NCT01380093|147610133|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.0181|TWO_SIDED|90.0|0.07|0.35|||Mixed Models Analysis|||Tmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.35|0.07|0.0181
73922046|NCT00174915|147372339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922047|NCT00174915|147372339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922048|NCT00174915|147372339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922049|NCT00174915|147372339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73967656|NCT03892616|147472859|OTHER||Ratio of adjusted geometric means [%]|152.9|||||TWO_SIDED|90.0|139.5|167.7|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||167.7|139.5|
73967657|NCT03892616|147472860|OTHER||Ratio of adjusted geometric means [%]|60.3|||||TWO_SIDED|90.0|55.4|65.7|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||65.7|55.4|
74028262|NCT01380093|147610134|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.75|||<|0.0001|TWO_SIDED|90.0|0.68|0.83|||Mixed Models Analysis|||Natural log transformed Cmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.83|0.68|<0.0001
74028263|NCT01380093|147610135|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.77||||0.0004|TWO_SIDED|90.0|0.69|0.86|||Mixed Models Analysis|||Natural log transformed AUC (0-1) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.86|0.69|0.0004
73922050|NCT00174915|147372339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922051|NCT00174915|147372339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
74028264|NCT01380093|147610136|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86||||0.0065|TWO_SIDED|90.0|0.79|0.94|||Mixed Models Analysis|||Natural log transformed AUC (0-2) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.94|0.79|0.0065
74028265|NCT01380093|147610137|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.98||||0.6399|TWO_SIDED|90.0|0.91|1.06|||Mixed Models Analysis|||Natural log transformed AUC (0-4) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.06|0.91|0.6399
74028266|NCT01380093|147610138|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0||||0.9057|TWO_SIDED|90.0|0.94|1.08|||Mixed Models Analysis|||Natural log transformed AUC (0-8) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.08|0.94|0.9057
74028267|NCT01380093|147610139|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.03||||0.425|TWO_SIDED|90.0|0.97|1.1|||Mixed Models Analysis|||Natural log transformed AUC (0-12) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.10|0.97|0.4250
74028268|NCT01380093|147610140|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.1||||0.0204|TWO_SIDED|90.0|1.03|1.18|||Mixed Models Analysis|||Natural log transformed AUC (0-24) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.18|1.03|0.0204
74028269|NCT01380093|147610141|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.32||||0.0005|TWO_SIDED|90.0|1.17|1.49|||Mixed Models Analysis|||Natural log transformed AUC (0-∞) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.49|1.17|0.0005
74028270|NCT00201201|147610164|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic (1,161)=4.44,p=0.035).||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use. Non-parametric tests (Cochran-Mantel-Haenszel statistic), based on rank scores, controlling for participant code were used for the transformed behavior risk scores within groups.||||0.035
74028271|NCT00201201|147610165|SUPERIORITY_OR_OTHER|||||||0.0204||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||.0204
74028272|NCT00201201|147610166|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||.0001
73922052|NCT00174915|147372339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922053|NCT00174915|147372339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
73922054|NCT00174915|147372340|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.789
73922055|NCT00174915|147372340|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.320
73922056|NCT00174915|147372340|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.381
73922057|NCT00174915|147372340|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.809
73922058|NCT00174915|147372340|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.154
73922059|NCT00174915|147372340|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.247
73922060|NCT00174915|147372340|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.415
73922061|NCT00174915|147372340|SUPERIORITY_OR_OTHER|||||||0.649||95.0||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.649
73922062|NCT00174915|147372340|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.807
73922063|NCT00174915|147372340|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.844
73922064|NCT00174915|147372341|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.699
73922065|NCT00174915|147372341|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.822
73922066|NCT00174915|147372341|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.579
73922067|NCT00174915|147372341|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.679
73922068|NCT00174915|147372341|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.278
74086809|NCT01115855|147727546|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.07|17.85||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||17.85|0.07|
74086810|NCT01115855|147727547|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.11|||||TWO_SIDED|95.0|0.39|11.56||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||11.56|0.39|
73922069|NCT00174915|147372341|SUPERIORITY_OR_OTHER|||||||0.104||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.104
73922070|NCT00174915|147372341|SUPERIORITY_OR_OTHER|||||||0.56||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.560
73922071|NCT00174915|147372341|SUPERIORITY_OR_OTHER|||||||0.309||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.309
73922072|NCT00174915|147372341|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.759
73922073|NCT00174915|147372341|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.385
73922074|NCT00174915|147372342|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.949
73922075|NCT00174915|147372342|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.050
73922076|NCT00174915|147372342|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.577
73922077|NCT00174915|147372342|SUPERIORITY_OR_OTHER|||||||0.598||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.598
73922078|NCT00174915|147372342|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.062
73922079|NCT00174915|147372342|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.969
73922080|NCT00174915|147372342|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.056
73922081|NCT00174915|147372342|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.659
73922082|NCT00174915|147372342|SUPERIORITY_OR_OTHER|||||||0.197||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.197
73922083|NCT00174915|147372342|SUPERIORITY_OR_OTHER|||||||0.521||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.521
73922084|NCT00174915|147372343|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.683
73922085|NCT00174915|147372343|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.078
73922086|NCT00174915|147372343|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.442
73922087|NCT00174915|147372343|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.990
73922088|NCT00174915|147372343|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.077
73922089|NCT00174915|147372343|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.662
73922090|NCT00174915|147372343|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.139
73967658|NCT03892616|147472860|OTHER||Ratio of adjusted geometric means [%]|71.1|||||TWO_SIDED|90.0|65.2|77.6|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||77.6|65.2|
73967659|NCT03892616|147472860|OTHER||Ratio of adjusted geometric means [%]|175.8|||||TWO_SIDED|90.0|160.8|192.2|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||192.2|160.8|
73967660|NCT03892616|147472860|OTHER||Ratio of adjusted geometric means [%]|150.2|||||TWO_SIDED|90.0|136.9|164.7|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||164.7|136.9|
73967661|NCT03892616|147472861|OTHER||Ratio of adjusted geometric means [%]|56.5|||||TWO_SIDED|90.0|51.8|61.7|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||61.7|51.8|
73967662|NCT03892616|147472861|OTHER||Ratio of adjusted geometric means [%]|70.5|||||TWO_SIDED|90.0|64.4|77.1|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||77.1|64.4|
73922091|NCT00174915|147372343|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.705
73922092|NCT00174915|147372343|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.337
73922093|NCT00174915|147372343|SUPERIORITY_OR_OTHER|||||||0.643||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.643
73922094|NCT00174915|147372344|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.645
73922095|NCT00174915|147372344|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.756
73922096|NCT00174915|147372344|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.428
73922097|NCT00174915|147372344|SUPERIORITY_OR_OTHER|||||||0.076||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons..|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL)||||||0.076
73922098|NCT00174915|147372344|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.106
73922099|NCT00174915|147372344|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.069
73922100|NCT00174915|147372344|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.837
73922101|NCT00174915|147372344|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.749
74028273|NCT00201201|147610167|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||0.0001
74028274|NCT00201201|147610168|SUPERIORITY_OR_OTHER|||||||0.0431||95.0|||||t-test, 2 sided|||||||0.0431
74028275|NCT00201201|147610169|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||t-test, 2 sided|||Analyzed at 0 and 12 weeks.||||<.10
74028276|NCT01342640|147610174|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 20 was analyzed using paired t-test.||||<0.0001
74028277|NCT01342640|147610175|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 24 was analyzed using paired t-test.||||<.0001
74028278|NCT01342640|147610176|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 28 was analyzed using paired t-test.||||<.0001
74028279|NCT04382651|147610206|SUPERIORITY||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|2.225||0.33|TWO_SIDED|90.0|-2.7|4.7||1-Sided|ANCOVA|||||4.7|-2.7|0.33
74028280|NCT01873742|147610212|OTHER|The BDI's Cronbach's alpha was .93 at start of therapy, and .95 at the end of therapy.|Mean Difference (Final Values)|1.01|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
74086811|NCT01115855|147727548|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.66||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||5.66|0.05|
74086812|NCT01115855|147727549|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.16|8.04||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||8.04|0.16|
73922102|NCT00174915|147372344|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.581
73922103|NCT00174915|147372344|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.311
73922104|NCT00183092|147372345|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.43||||0.43|TWO_SIDED|95.0|0.58|3.53|||Regression, Cox|||||3.53|0.58|0.43
73931042|NCT05569954|147391863|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|4.61|||<|0.001|TWO_SIDED|95.0|3.99|5.33||1-sided|cLDA model||V116/PPSV23|Serotype 15A: V116/PPSV23 GMT Ratio||5.33|3.99|<0.001
74028281|NCT02075255|147610237|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|33.3|||<|0.001|TWO_SIDED|95.0|16.7|50.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate is used.|||50.00|16.70|<0.001
74028282|NCT02075255|147610237|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|37.5|||<|0.001|TWO_SIDED|95.0|20.8|50.0|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||50.00|20.80|<0.001
74028283|NCT02075255|147610238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.22|7.57|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.||||7.57|2.22|<0.001
74028284|NCT02075255|147610238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.001|TWO_SIDED|95.0|2.22|7.63|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.||||7.63|2.22|<0.001
74028285|NCT02075255|147610239|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|50.0|||<|0.001|TWO_SIDED|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||66.70|25.00|<0.001
74028286|NCT02075255|147610239|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|50.0|||<|0.001|TWO_SIDED|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||66.70|25.00|<0.001
74028287|NCT02075255|147610240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.001|TWO_SIDED|95.0|1.79|7.22|||Cochran-Mantel-Haenszel|Controlling for region.||||7.22|1.79|<0.001
74028288|NCT02075255|147610240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.57|5.86|||Cochran-Mantel-Haenszel|Controlling for region.||||5.86|1.57|<0.001
74028289|NCT02075255|147610241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23|||<|0.001|TWO_SIDED|95.0|1.92|14.21|||Cochran-Mantel-Haenszel|Controlling for region.||||14.21|1.92|<0.001
74028290|NCT02075255|147610241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19||||0.002|TWO_SIDED|95.0|1.58|11.12|||Cochran-Mantel-Haenszel|Controlling for region.||||11.12|1.58|0.002
74028291|NCT02075255|147610242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.012|TWO_SIDED|95.0|0.21|0.83|||Cochran-Mantel-Haenszel|Controlling for region.||||0.83|0.21|0.012
74028292|NCT02075255|147610242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.053|TWO_SIDED|95.0|0.27|1.01|||Cochran-Mantel-Haenszel|Controlling for region.||||1.01|0.27|0.053
74028293|NCT02075255|147610243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.6|6.23|||Cochran-Mantel-Haenszel|Controlling for region.||||6.23|1.60|<0.001
73861579|NCT02699450|147269030|SUPERIORITY||Difference in Least Squares Means|-12.4||||0.36|TWO_SIDED|80.0|-29.7|5.0||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||5.0|-29.7|0.36
73922105|NCT00183092|147372346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5||||0.54||95.0||||Threshold for statistical significance = 0.05. One subject in the placebo group was administered only 25 items on the MMSE due to visual impairment, and this subject's score was scaled based on percentage correct.|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||.54
73861580|NCT02699450|147269030|SUPERIORITY||Difference in Least Squares Means|-21.1||||0.13|TWO_SIDED|80.0|-38.7|-3.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-3.5|-38.7|0.13
73861581|NCT02699450|147269031|SUPERIORITY||Difference in Least Squares Means|-38.6||||0.07|TWO_SIDED|80.0|-65.9|-11.3||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||-11.3|-65.9|0.07
73861582|NCT02699450|147269032|SUPERIORITY||Difference in Least Squares Means|-20.1||||0.12|TWO_SIDED|80.0|-36.4|-3.8||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-3.8|-36.4|0.12
73861583|NCT02699450|147269032|SUPERIORITY||Difference in Least Squares Means|-26.7||||0.02|TWO_SIDED|80.0|-41.3|-12.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-12.0|-41.3|0.02
73861584|NCT02699450|147269033|SUPERIORITY||Difference in Percentage of Participants|-4.08||||0.4948|TWO_SIDED|80.0|-7.7|-0.46||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-0.46|-7.70|0.4948
73861585|NCT02699450|147269033|SUPERIORITY||Difference in Percentage of Participants|-4.08||||0.496|TWO_SIDED|80.0|-7.7|-0.46||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-0.46|-7.70|0.4960
73922106|NCT00183092|147372347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.9||||0.36||95.0||||significance threshold p=0.05|Quade's rank analysis of covariance|||The difference between scores, adjusted for Month-0 performance.||||.36
73922107|NCT00183092|147372348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.01||95.0||||Significance threshold p\<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||.01
73922108|NCT00183092|147372349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.03||95.0||||Threshold for significance p\<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.03
74028294|NCT02075255|147610243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.002|TWO_SIDED|95.0|1.41|5.31|||Cochran-Mantel-Haenszel|Controlling for region.||||5.31|1.41|0.002
74028295|NCT02075255|147610244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.001|TWO_SIDED|95.0|0.16|0.65|||Cochran-Mantel-Haenszel|Controlling for region.||||0.65|0.16|0.001
74028296|NCT02075255|147610244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|||<|0.001|TWO_SIDED|95.0|0.14|0.56|||Cochran-Mantel-Haenszel|Controlling for region.||||0.56|0.14|<0.001
73861586|NCT02699450|147269034|SUPERIORITY||Difference in Percentage of Participants|-2.8||||1|TWO_SIDED|80.0|-11.08|5.49||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||5.49|-11.08|1.0000
73861587|NCT02699450|147269035|SUPERIORITY||Difference in Percentage of Participants|-6.12||||0.5759|TWO_SIDED|80.0|-15.41|3.17||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.17|-15.41|0.5759
73861588|NCT02699450|147269035|SUPERIORITY||Difference in Percentage of Participants|3.15||||0.7437|TWO_SIDED|80.0|-5.02|11.33||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||11.33|-5.02|0.7437
73861589|NCT02699450|147269036|SUPERIORITY||Difference in Percentage of Participants|2.02||||1|TWO_SIDED|80.0|-8.6|12.64||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||12.64|-8.60|1.0000
73861590|NCT00700102|147269064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0062|TWO_SIDED|95.0|0.69|0.94|||Log Rank|||||0.94|0.69|0.0062
73861591|NCT00700102|147269065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1713|TWO_SIDED|95.0|0.77|1.05|||Log Rank|||Kaplan Meier Estimate||1.05|0.77|0.1713
73861592|NCT00700102|147269067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.59|0.78|||Log Rank|||||0.78|0.59|<.0001
73922109|NCT00183092|147372350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.92||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.92
73861593|NCT00700102|147269068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.3113|TWO_SIDED|95.0|-1.5|4.5|||Chi-squared|||||4.5|-1.5|0.3113
73861594|NCT00700102|147269068|SUPERIORITY_OR_OTHER|||||||0.4315|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4315
73861595|NCT02525939|147269070|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.12|TWO_SIDED|95.0|0.75|1.03||The estimated HR was presented with a 95% CI and a p-value. The primary analysis was conducted at the 0.05 significance level.|Stratified Cox proportional hazard model|||A stratified Cox proportional hazards model was used to analyze the primary endpoint. This model included treatment as a main effect, and region and acute coronary syndrome (ACS) index event type as stratification factors. The null and alternative hypotheses tested with the above Cox model were: H0: λ = 1 vs HA: λ ≠ 1, where λ is the, assumed constant, hazard ratio (HR) for the time to occurrence of the composite events of the primary endpoint for the dalcetrapib and placebo treated groups.||1.03|0.75|0.12
73861596|NCT02525939|147269071|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.95|TWO_SIDED|95.0|0.88|1.13|||Stratified Cox proportional hazard model|||Secondary endpoints were expressed as time to event and an analysis similar to that for the primary endpoint was conducted. In order to control the family-wise Type I error that results from the multiplicity of endpoints, the secondary endpoints were formally tested using the Hochberg's step-up procedure only if the primary analysis results in significant treatment effect at p\<0.05. Otherwise, statistical tests for the secondary endpoints were presented solely for illustrative purposes.||1.13|0.88|0.95
73861597|NCT02525939|147269072|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.27|TWO_SIDED|95.0|0.79|1.07|||Stratified Cox proportional hazard model|||Secondary endpoints were expressed as time to event and an analysis similar to that for the primary endpoint was conducted. In order to control the family-wise Type I error that results from the multiplicity of endpoints, the secondary endpoints were formally tested using the Hochberg's step-up procedure only if the primary analysis results in significant treatment effect at p\<0.05. Otherwise, statistical tests for the secondary endpoints were presented solely for illustrative purposes.||1.07|0.79|0.27
73922110|NCT00183092|147372351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.71||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.71
73967663|NCT03892616|147472861|OTHER||Ratio of adjusted geometric means [%]|185.3|||||TWO_SIDED|90.0|169.4|202.8|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||202.8|169.4|
73922111|NCT00183092|147372352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.7||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted change (worsening) in the quinacrine group.||||0.70
73922112|NCT03060447|147372354|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 1: Day 2||||0.55
73967664|NCT03892616|147472861|OTHER||Ratio of adjusted geometric means [%]|158.4|||||TWO_SIDED|90.0|144.3|173.9|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||173.9|144.3|
74086813|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-102.93|STANDARD_ERROR_OF_MEAN|47.13|||TWO_SIDED|95.0|-195.92|-9.94||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-9.94|-195.92|
74086814|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-95.77|STANDARD_ERROR_OF_MEAN|44.54|||TWO_SIDED|95.0|-184.51|-7.04||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-7.04|-184.51|
74086815|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-125.09|STANDARD_ERROR_OF_MEAN|35.15|||TWO_SIDED|95.0|-195.5|-54.68||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-54.68|-195.50|
74086816|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.94|STANDARD_ERROR_OF_MEAN|51.12|||TWO_SIDED|95.0|-232.77|-31.11||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-31.11|-232.77|
74086817|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-132.39|STANDARD_ERROR_OF_MEAN|52.77|||TWO_SIDED|95.0|-240.94|-23.84||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-23.84|-240.94|
73922113|NCT03060447|147372354|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 1: Day 8||||0.54
74086818|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-117.18|STANDARD_ERROR_OF_MEAN|51.76|||TWO_SIDED|95.0|-221.49|-12.87||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-12.87|-221.49|
74086819|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-101.5|STANDARD_ERROR_OF_MEAN|61.05|||TWO_SIDED|95.0|-267.36|64.36||||||Change from baseline at Month 29 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||64.36|-267.36|
74086820|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-110.78|STANDARD_ERROR_OF_MEAN|92.42|||TWO_SIDED|95.0|-307.49|85.93||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||85.93|-307.49|
74086821|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-119.62|STANDARD_ERROR_OF_MEAN|158.84|||TWO_SIDED|95.0|-2137.82|1898.59||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1898.59|-2137.82|
74086822|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-144.6|STANDARD_ERROR_OF_MEAN|200.56|||TWO_SIDED|90.0|-2692.95|2403.76||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||2403.76|-2692.95|
74086823|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-77.26|STANDARD_ERROR_OF_MEAN|966.09|||TWO_SIDED|95.0|-2131.88|1977.37||||||Change from baseline at Month 48 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1977.37|-2131.88|
73922114|NCT03060447|147372354|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 2: Day 1||||0.54
74086824|NCT01115855|147727551|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-102.3|STANDARD_ERROR_OF_MEAN|35.67|||TWO_SIDED|95.0|-172.61|-32.0||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-32.00|-172.61|
73922115|NCT03060447|147372354|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 2: Day 8||||0.54
73922116|NCT03060447|147372354|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 3: Day 1||||0.54
73922117|NCT03060447|147372354|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 3: Day 8||||0.57
73922118|NCT03060447|147372354|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 1||||0.54
73967665|NCT03843151|147472862|OTHER||Ratio|192.67|||||TWO_SIDED|90.0|175.19|211.89|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 14.9."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||211.89|175.19|
73967666|NCT03843151|147472863|OTHER||Ratio|120.72|||||TWO_SIDED|90.0|105.69|137.87|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 21.7."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||137.87|105.69|
73967667|NCT03843151|147472864|OTHER||Ratio|120.72|||||TWO_SIDED|90.0|105.69|137.87|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 13.3."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||137.87|105.69|
73967668|NCT01781468|147472868|SUPERIORITY|||||||0.9601|||||||Fisher Exact|||||||0.9601
73967669|NCT01781468|147472869|SUPERIORITY|||||||0.7877|||||||Fisher Exact|||||||0.7877
73967670|NCT01781468|147472870|SUPERIORITY|||||||0.3272|||||||Kruskal-Wallis|||||||0.3272
73967671|NCT01781468|147472871|SUPERIORITY|||||||0.9122|||||||Kruskal-Wallis|||Baseline to Week 4||||0.9122
73967672|NCT01781468|147472871|SUPERIORITY|||||||0.8559|||||||Kruskal-Wallis|||Baseline to Week 8||||0.8559
73967673|NCT04986501|147472873|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
73967674|NCT04986501|147472875|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
74028297|NCT02075255|147610245|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.22|0.66|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.||||0.66|0.22|<0.001
74028298|NCT02075255|147610245|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.17|0.57|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.||||0.57|0.17|<0.001
74028299|NCT02075255|147610246|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.291|TWO_SIDED|95.0|0.14|1.64|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.||||1.64|0.14|0.291
74028300|NCT02075255|147610246|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.12||||0.042|TWO_SIDED|95.0|0.01|0.63|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.||||0.63|0.01|0.042
74028301|NCT02075255|147610247|SUPERIORITY_OR_OTHER||Rate ratio|0.45||||0.003|TWO_SIDED|95.0|0.27|0.76|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.||||0.76|0.27|0.003
74028302|NCT02075255|147610247|SUPERIORITY_OR_OTHER||Rate ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.17|0.53|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.||||0.53|0.17|<0.001
74028303|NCT02075255|147610248|SUPERIORITY_OR_OTHER||Rate ratio|0.44||||0.187|TWO_SIDED|95.0|0.13|1.49|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.||||1.49|0.13|0.187
74028304|NCT02075255|147610248|SUPERIORITY_OR_OTHER||Rate ratio|0.07||||0.018|TWO_SIDED|95.0|0.01|0.63|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.||||0.63|0.01|0.018
74028305|NCT02075255|147610250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.153|TWO_SIDED|95.0|-0.04|0.251|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.||||0.251|-0.040|0.153
74028306|NCT02075255|147610250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112||||0.129|TWO_SIDED|95.0|-0.033|0.258|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.||||0.258|-0.033|0.129
74028307|NCT02075255|147610251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.947|TWO_SIDED|95.0|-0.35|0.32|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.32|-0.35|0.947
74028308|NCT02075255|147610251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.291|TWO_SIDED|95.0|-0.51|0.16|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.16|-0.51|0.291
73922119|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 2||||0.52
73922120|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 4||||0.52
73922121|NCT03060447|147372354|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 8||||0.61
73922122|NCT03060447|147372354|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 5: Day 1||||0.54
73922123|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 5: Day 8||||0.52
73922124|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 6: Day 1||||0.52
73922125|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 6: Day 4||||0.52
73922126|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 6: Day 8||||0.52
73922127|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 7: Day 1||||0.52
74028309|NCT02075255|147610252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.18|0.18|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.18|-0.18|0.998
73922128|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 7 - Day 8||||0.52
73922129|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 8: Day 1||||0.52
73922130|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 8: Day 8||||0.52
73922131|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 9: Day 1||||0.52
73922132|NCT03060447|147372354|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 9: Day 8||||1.00
73922133|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 10: Day 1||||0.52
73922134|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 2||||0.52
73922135|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 4||||0.52
74028310|NCT02075255|147610252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.177|TWO_SIDED|95.0|-0.3|0.05|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.05|-0.30|0.177
73922136|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 8||||0.52
73922137|NCT03060447|147372354|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 14||||0.52
73922138|NCT03060447|147372355|SUPERIORITY|||||||0.035|||||||Log Rank|P-value between treatment groups was based on log-rank test.||≥ 50 Copies/mL||||0.035
73922139|NCT03060447|147372355|SUPERIORITY|||||||0.024|||||||Log Rank|P-value between treatment groups was based on log-rank test.||≥ 200 Copies/mL||||0.024
73922140|NCT03060447|147372356|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|P-values between treatment groups were based on Wilcoxon rank sum test.||||||0.67
73922141|NCT03060447|147372357|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|P-values between treatment groups were based on Wilcoxon rank sum test.||||||0.78
73922142|NCT03060447|147372358|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Baseline||||0.34
73922143|NCT03060447|147372358|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 1: Day 2||||0.11
73922144|NCT03060447|147372358|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 1: Day 8||||0.81
73922145|NCT03060447|147372358|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 1||||0.83
73922146|NCT03060447|147372358|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 2||||0.12
73922147|NCT03060447|147372358|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 8||||0.45
73922148|NCT03060447|147372358|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 1||||0.25
73922149|NCT03060447|147372358|SUPERIORITY|||||||0.053|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 2||||0.053
73922150|NCT03060447|147372358|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 8||||0.16
73922151|NCT03060447|147372358|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, ATI Remission Visit||||0.27
73922152|NCT03060447|147372358|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Baseline||||0.35
73922153|NCT03060447|147372358|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 1: Day 2||||0.013
73922154|NCT03060447|147372358|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 1: Day 8||||0.15
73922155|NCT03060447|147372358|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 1||||0.30
74028311|NCT02075255|147610253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.973|TWO_SIDED|95.0|-0.17|0.17|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.17|-0.17|0.973
73967675|NCT03930342|147472878|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.83|1.07|||Regression, Logistic|Used marginal standardization to estimate relative risk from logistic regression||Results here reflect analysis of the relative risk for AEP that is a combination of risk from baseline to the 3 month timepoint and risk between the 3 month timepoint and 6 month timepoint. This reflects changes in AEP risk across the course of exposure to the intervention (baseline to 3 month) and enduring change post-exposure (3 months to 6 months)||1.07|0.83|
73967676|NCT05034952|147472927|SUPERIORITY|||||||0.3914|||||||ANCOVA|||||||0.3914
74028312|NCT02075255|147610253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.48|TWO_SIDED|95.0|-0.23|0.11|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.11|-0.23|0.480
74086825|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-364.65|STANDARD_ERROR_OF_MEAN|763.83|||TWO_SIDED|95.0|-1863.06|1133.76||||||Change from baseline at Month 5 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1133.76|-1863.06|
74086826|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-247.14|STANDARD_ERROR_OF_MEAN|711.26|||TWO_SIDED|95.0|-1642.43|1148.14||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1148.14|-1642.43|
73967677|NCT05034952|147472927|SUPERIORITY|||||||0.1266|||||||ANCOVA|||||||0.1266
73967678|NCT05034952|147472927|SUPERIORITY|||||||0.0097|||||||ANCOVA|||||||0.0097
73967679|NCT05034952|147472928|SUPERIORITY|||||||0.5476|||||||ANCOVA|||||||0.5476
73967680|NCT05034952|147472928|SUPERIORITY|||||||0.0825|||||||ANCOVA|||||||0.0825
74028313|NCT02075255|147610254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.397|TWO_SIDED|95.0|-1.44|0.57|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.||||0.57|-1.44|0.397
74086827|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-370.14|STANDARD_ERROR_OF_MEAN|699.58|||TWO_SIDED|95.0|-1742.51|1002.22||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1002.22|-1742.51|
74086828|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-664.09|STANDARD_ERROR_OF_MEAN|11059.62|||TWO_SIDED|95.0|-141189.93|139861.75||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||139861.75|-141189.93|
74086829|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-414.99|STANDARD_ERROR_OF_MEAN|3071.77|||TWO_SIDED|95.0|-39445.52|38615.54||||||Change from baseline at Month 21 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||38615.54|-39445.52|
74086830|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|23.86|STANDARD_ERROR_OF_MEAN|10794.85|||TWO_SIDED|95.0|-21649.89|21697.6||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||21697.60|-21649.89|
74086831|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-245.23|STANDARD_ERROR_OF_MEAN|6698.57|||TWO_SIDED|95.0|-85358.69|84868.22||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||84868.22|-85358.69|
74086832|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|170.49|STANDARD_ERROR_OF_MEAN|10730.38|||TWO_SIDED|95.0|-21375.69|21716.66||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||21716.66|-21375.69|
74086833|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-58.77|STANDARD_ERROR_OF_MEAN|12765.3|||TWO_SIDED|95.0|-30160.25|30042.7||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||30042.70|-30160.25|
74086834|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-212.25|STANDARD_ERROR_OF_MEAN|11073.11|||TWO_SIDED|90.0|-22723.82|22299.33||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||22299.33|-22723.82|
74086835|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-80.16|STANDARD_ERROR_OF_MEAN|11486.21|||TWO_SIDED|95.0|-146026.28|145865.96||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||145865.96|-146026.28|
74086836|NCT01115855|147727552|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-187.72|STANDARD_ERROR_OF_MEAN|240.96|||TWO_SIDED|95.0|-662.67|287.23||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||287.23|-662.67|
73967681|NCT05034952|147472928|SUPERIORITY|||||||0.0036|||||||ANCOVA|||||||0.0036
73967682|NCT05034952|147472929|SUPERIORITY|||||||0.4712|||||||Cochran-Mantel-Haenszel|||||||0.4712
73967683|NCT05034952|147472929|SUPERIORITY|||||||0.1635|||||||Cochran-Mantel-Haenszel|||||||0.1635
73922156|NCT03060447|147372358|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 2||||0.003
73922157|NCT03060447|147372358|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 8||||0.49
73922158|NCT03060447|147372358|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 1||||0.25
73922159|NCT03060447|147372358|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 2||||0.055
73922160|NCT03060447|147372358|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 8||||0.90
73967684|NCT05034952|147472929|SUPERIORITY|||||||0.1158|||||||Cochran-Mantel-Haenszel|||||||0.1158
73967685|NCT05034952|147472930|SUPERIORITY|||||||0.2882|||||||Cochran-Mantel-Haenszel|||||||0.2882
73967686|NCT05034952|147472930|SUPERIORITY|||||||0.2344|||||||Cochran-Mantel-Haenszel|||||||0.2344
73967687|NCT05034952|147472930|SUPERIORITY|||||||0.1724|||||||Cochran-Mantel-Haenszel|||||||0.1724
73967688|NCT05034952|147472931|SUPERIORITY|||||||0.1343|||||||Cochran-Mantel-Haenszel|||||||0.1343
73967689|NCT05034952|147472931|SUPERIORITY|||||||0.4501|||||||Cochran-Mantel-Haenszel|||||||0.4501
73967690|NCT05034952|147472931|SUPERIORITY|||||||0.1009|||||||Cochran-Mantel-Haenszel|||||||0.1009
73967691|NCT02111798|147472937|SUPERIORITY|||||||0.889|||||||Mixed Models Analysis|||Comparisons were conducted as a function of medication condition, collapsed across abstinence initiation and relapse prevention groups, according to a priori-stated statistical analysis.||||0.889
73967692|NCT02111798|147472938|SUPERIORITY|||||||0.605|||||||Mixed Models Analysis|||Comparisons were conducted as a function of medication condition, collapsed across abstinence initiation and relapse prevention groups, according to a priori-stated statistical analysis.||||0.605
73967693|NCT03761537|147472939|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.1||||0.018|TWO_SIDED|95.0|2.5|25.7||This endpoint was the first endpoint in the sequential testing hierarchy.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.7|2.5|0.018
74028314|NCT02075255|147610254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.41||||0.006|TWO_SIDED|95.0|-2.42|-0.41|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.||||-0.41|-2.42|0.006
74028315|NCT02075255|147610255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.25||||0.143|TWO_SIDED|95.0|-6.58|45.07|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.||||45.07|-6.58|0.143
73922161|NCT03060447|147372358|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, ATI Remission Visit||||0.39
73922162|NCT03060447|147372358|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Baseline||||0.75
73922163|NCT03060447|147372358|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 1: Day 2||||<0.001
74028316|NCT02075255|147610255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.01||||0.023|TWO_SIDED|95.0|4.26|55.76|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.||||55.76|4.26|0.023
74028317|NCT02075255|147610256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.19||||0.237|TWO_SIDED|95.0|-10.08|40.46|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.||||40.46|-10.08|0.237
74028318|NCT02075255|147610256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.52||||0.014|TWO_SIDED|95.0|6.32|56.71|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.||||56.71|6.32|0.014
73922164|NCT03060447|147372358|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 1: Day 8||||0.69
73922165|NCT03060447|147372358|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 1||||0.15
73922166|NCT03060447|147372358|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 2||||0.018
73922167|NCT03060447|147372358|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 8||||0.030
73922168|NCT03060447|147372358|SUPERIORITY|||||||0.087|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 1||||0.087
73922169|NCT03060447|147372358|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 2||||<0.001
73922170|NCT03060447|147372358|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 8||||0.066
73922171|NCT03060447|147372358|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, ATI Remission||||0.86
73922172|NCT03060447|147372358|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Baseline||||0.19
74028319|NCT02075255|147610257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.742|TWO_SIDED|95.0|-0.08|0.11|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.||||0.11|-0.08|0.742
74028320|NCT02075255|147610257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.693|TWO_SIDED|95.0|-0.11|0.07|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.||||0.07|-0.11|0.693
73922173|NCT03060447|147372358|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 1: Day 2||||0.021
73922174|NCT03060447|147372358|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 1: Day 8||||0.31
73922175|NCT03060447|147372358|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 1||||0.10
73922176|NCT03060447|147372358|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 2||||0.018
73922177|NCT03060447|147372358|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 8||||0.69
73922178|NCT03060447|147372358|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 1||||0.46
73922179|NCT03060447|147372358|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 2||||0.21
73922180|NCT03060447|147372358|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 8||||0.67
74028321|NCT02075255|147610258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.139|TWO_SIDED|95.0|-0.55|0.08|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.||||0.08|-0.55|0.139
74028322|NCT02075255|147610258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.001|TWO_SIDED|95.0|-0.86|-0.23|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.||||-0.23|-0.86|0.001
74028323|NCT02075255|147610259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.165||||0.658|TWO_SIDED|95.0|0.592|2.295|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.||||2.295|0.592|0.658
74028324|NCT02075255|147610259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.661||||0.155|TWO_SIDED|95.0|0.826|3.34|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.||||3.340|0.826|0.155
74086837|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.71|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-0.55|3.96||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||3.96|-0.55|
73922181|NCT03060447|147372358|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, ATI Remission||||0.60
73922182|NCT03060447|147372359|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 1: Day 2||||0.002
73922183|NCT03060447|147372359|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 4: Day 1||||0.58
73922184|NCT03060447|147372359|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 4: Day 2||||0.009
73922185|NCT03060447|147372359|SUPERIORITY|ISG15, Dose 10: Day 1||||||0.031|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.031
73922186|NCT03060447|147372359|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 10: Day 2||||0.001
73922187|NCT03060447|147372359|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 1: Day 2||||0.003
73922188|NCT03060447|147372359|SUPERIORITY|||||||0.057|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 4: Day 1||||0.057
73922189|NCT03060447|147372359|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 4: Day 2||||0.009
73922190|NCT03060447|147372359|SUPERIORITY|||||||0.057|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 10: Day 1||||0.057
73922191|NCT03060447|147372359|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 10: Day 2||||0.005
73922192|NCT03060447|147372359|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 1: Day 2||||<0.001
73922193|NCT03060447|147372359|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 4: Day 1||||0.17
73922194|NCT03060447|147372359|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 4: Day 2||||0.003
73922195|NCT03060447|147372359|SUPERIORITY|MX1, Dose 10: Day 1||||||0.1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.100
73922196|NCT03060447|147372359|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 10: Day 2||||<0.001
73922197|NCT03060447|147372360|SUPERIORITY|||||||0.7469|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Baseline||||0.7469
73922198|NCT03060447|147372360|SUPERIORITY|||||||0.1207|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 1||||0.1207
73922199|NCT03060447|147372360|SUPERIORITY|||||||0.4113|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 2||||0.4113
73922200|NCT03060447|147372360|SUPERIORITY|||||||0.1113|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 4||||0.1113
73922201|NCT03060447|147372360|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 6: Day 1||||0.2410
73922202|NCT03060447|147372360|SUPERIORITY|||||||0.1098|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 6: Day 4||||0.1098
74028325|NCT02075255|147610260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.151|TWO_SIDED|95.0|-0.08|0.53|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.||||0.53|-0.08|0.151
73861598|NCT00086502|147269137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.73|<|0.001||95.0|-0.85|-0.54||"Model terms: treatment; baseline; prior antihyperglycemic~agent (AHA) therapy \[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\]"|ANCOVA|||||-0.54|-0.85|<0.001
73861599|NCT00086502|147269138|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7|STANDARD_DEVIATION|30.9|<|0.001||95.0|-24.3|-11.0||Model terms: treatment; baseline; prior antihyperglycemic agent (AHA) therapy \[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\]|ANCOVA|||||-11.0|-24.3|<0.001
73861600|NCT01643876|147269140|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.5|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: in individuals with denture stomatitis, there are no difference in the extent of palatal inflammation before and 3 months after palatal brushing. Assuming that the minimal practically important pre/post difference in the mean change score is 20 percent and the standard deviation of the distribution of the change in score is 0.8, a sample size of 44 participants is required to ensure a power of 90 % of rejecting the null hypothesis if it is indeed false.||||<0.0001
73861601|NCT01643876|147269141|SUPERIORITY_OR_OTHER||Median Difference (Net)|-57.5|||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: in individuals with denture stomatitis, there are no difference in the number of Candida Colony-Forming Units (CFUs), before and 3 months after palatal brushing.||||<0.05
73861602|NCT02469714|147269142|SUPERIORITY||Mean Difference (Final Values)|0.66||||0.04|TWO_SIDED||||||ANCOVA|||Between group comparison of total scheduled appointments from 1-13 months||||.04
73922203|NCT03060447|147372360|SUPERIORITY|||||||0.0369|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 1||||0.0369
73922204|NCT03060447|147372360|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 2||||0.0814
73967694|NCT03761537|147472940|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|9.7||||0.106|TWO_SIDED|95.0|-2.0|21.4||This endpoint was the second endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||21.4|-2.0|0.106
74086838|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|95.0|0.07|5.42||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||5.42|0.07|
73861603|NCT02469714|147269142|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.008|TWO_SIDED||||||ANCOVA|||Between group comparison of total achieved appointments from 1-13 months||||.008
73861604|NCT02469714|147269143|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.135|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.135
73861605|NCT02469714|147269144|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.077|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.077
73861606|NCT02469714|147269145|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.0005|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.0005
73861607|NCT02469714|147269146|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.06|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.060
73861608|NCT02469714|147269147|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.073|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.073
73861609|NCT02469714|147269148|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.34|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.34
73861610|NCT02469714|147269149|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.21|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.21
73861611|NCT01515475|147269150|OTHER||Risk Difference (RD)|3.0||||0.72|TWO_SIDED|95.0|-12.0|18.0|||Barnard's Exact Test|||||18|-12|0.72
73861612|NCT01515475|147269150|OTHER||Risk Difference (RD)|-13.0||||0.14|TWO_SIDED|95.0|-31.0|4.0|||Barnard's Exact Test|||||4|-31|0.14
73922205|NCT03060447|147372360|SUPERIORITY|||||||0.1658|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 4||||0.1658
73922206|NCT03060447|147372360|SUPERIORITY|||||||0.9431|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 14||||0.9431
73922207|NCT03060447|147372360|SUPERIORITY|||||||0.6514|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Baseline||||0.6514
73922208|NCT03060447|147372360|SUPERIORITY|||||||0.0821|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 1||||0.0821
73922209|NCT03060447|147372360|SUPERIORITY|||||||0.2353|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 2||||0.2353
73922210|NCT03060447|147372360|SUPERIORITY|||||||0.1779|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 4||||0.1779
73922211|NCT03060447|147372360|SUPERIORITY|||||||0.7491|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 6: Day 1||||0.7491
73922212|NCT03060447|147372360|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 6: Day 4||||0.0700
73922213|NCT03060447|147372360|SUPERIORITY|||||||0.3711|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 1||||0.3711
73922214|NCT03060447|147372360|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 2||||0.0814
73922215|NCT03060447|147372360|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 4||||0.0700
73922216|NCT03060447|147372360|SUPERIORITY|||||||0.8303|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 14||||0.8303
73922217|NCT03060447|147372360|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Baseline||||0.9530
73922218|NCT03060447|147372360|SUPERIORITY|||||||0.1735|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 1||||0.1735
73922219|NCT03060447|147372360|SUPERIORITY|||||||0.2971|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 2||||0.2971
73922220|NCT03060447|147372360|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 4||||1.0000
73967695|NCT03761537|147472941|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-8.6|||<|0.001|TWO_SIDED|95.0|-13.0|-4.2||This was the third endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Treatment effect at each visit adjusted for baseline SCORAD interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-4.2|-13.0|<0.001
73967696|NCT03761537|147472942|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-1.5||||0.009|TWO_SIDED|95.0|-2.6|-0.4||This was the fourth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Treatment effect at each visit adjusted for baseline DLQI interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-0.4|-2.6|0.009
74086839|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.86|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|1.11|6.6||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||6.60|1.11|
73922221|NCT03060447|147372360|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 6: Day 1||||1.0000
73922222|NCT03060447|147372360|SUPERIORITY|||||||0.3374|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 6: Day 4||||0.3374
73922223|NCT03060447|147372360|SUPERIORITY|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 1||||0.7656
73922224|NCT03060447|147372360|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 2||||0.0814
73922225|NCT03060447|147372360|SUPERIORITY|||||||0.3374|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 4||||0.3374
73922226|NCT03060447|147372360|SUPERIORITY|||||||0.432|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 14||||0.4320
73922227|NCT03060447|147372360|SUPERIORITY|||||||0.8597|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Baseline||||0.8597
73922228|NCT03060447|147372360|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 1||||1.0000
73922229|NCT03060447|147372360|SUPERIORITY|||||||0.0306|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 2||||0.0306
73922230|NCT03060447|147372360|SUPERIORITY|||||||0.8345|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 4||||0.8345
73922231|NCT03060447|147372360|SUPERIORITY|||||||0.9151|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 6: Day 1||||0.9151
73922232|NCT03060447|147372360|SUPERIORITY|||||||0.1098|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 6: Day 4||||0.1098
73922233|NCT03060447|147372360|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 1||||1.0000
73922234|NCT03060447|147372360|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 2||||0.0814
73922235|NCT03060447|147372360|SUPERIORITY|||||||0.4555|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 4||||0.4555
73922236|NCT03060447|147372360|SUPERIORITY|||||||0.6171|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 14||||0.6171
73922237|NCT03060447|147372360|SUPERIORITY|||||||0.0677|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Baseline||||0.0677
73922238|NCT03060447|147372360|SUPERIORITY|||||||0.4712|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 1||||0.4712
73922239|NCT03060447|147372360|SUPERIORITY|||||||0.6889|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 2||||0.6889
73922240|NCT03060447|147372360|SUPERIORITY|||||||0.1437|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 4||||0.1437
73922241|NCT03060447|147372360|SUPERIORITY|||||||0.7491|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 6: Day 1||||0.7491
73922242|NCT03060447|147372360|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 6: Day 4||||0.0700
73922243|NCT03060447|147372360|SUPERIORITY|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 1||||0.7656
73922244|NCT03060447|147372360|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 2||||0.1752
73922245|NCT03060447|147372360|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 4||||0.0700
73922246|NCT03060447|147372360|SUPERIORITY|CD69+CD56brCD16dim, Dose 10: Day 14||||||0.2246|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.2246
73922247|NCT03274440|147372378|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.577|||||||Linear mixed effects regression|||Test for interaction effect between condition and time (includes all three groups and all time points)||||.577
73922248|NCT03274440|147372378|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.|||||<|0.001|||||||Linear mixed effects regression|F=10.50; df=6, 10||Test for main effect of time (includes all three groups and all time points)||||<.001
73922249|NCT03274440|147372378|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.72|||||||Linear mixed effects regression|||Test for main effect of condition (includes all three groups and all time points)||||.72
74086840|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.86|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|1.81|7.9||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.90|1.81|
73922250|NCT03274440|147372379|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.577|||||||Linear mixed effects regression|||Test for interaction between condition and time||||.577
73922251|NCT03274440|147372379|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.|||||<|0.001|||||||Linear mixed effects regression|F=7.00, df=6,10||Test for main effect of time||||<.001
73922252|NCT03274440|147372379|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.002|||||||Linear mixed effects regression|F=6.26, df=2, 10||Test for main effect of condition||||.002
73922253|NCT04984993|147372389|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 0 versus alternative hypothesis: mu \>0, where mu is the population mean change from baseline in the EF domain of the IIEF questionnaire at week 24.||||<0.001
73922254|NCT04984993|147372390|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 15 minutes.||||<0.001
73922255|NCT04984993|147372390|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 10 minutes.||||<0.001
73922256|NCT04984993|147372390|OTHER|||||||0.89||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 5 minutes.||||0.890
73922257|NCT04984993|147372391|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||||||<0.001
73922258|NCT04984993|147372391|OTHER|||||||0.3327||||||Significance level of 0.025|t-test, 1 sided|||||||0.3327
73922259|NCT04984993|147372391|OTHER||||||>|0.999||||||Significance level of 0.025|t-test, 1 sided|||||||>0.999
73922260|NCT02865187|147372392|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|7.0||0.71|TWO_SIDED|95.0|-7.4|5.1||a priori threshold for significance was set at p\<0.05|t-test, 2 sided|||||5.1|-7.4|0.71
73922261|NCT02865187|147372393|SUPERIORITY||Chi square|0.0||||1|TWO_SIDED|||||a priori threshold for significance was set at p\< 0.05.|Chi-squared|||||||1.00
73922262|NCT00385996|147372432|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Binomial distribution|Binomial distribution and test proportion =0.50||One arm phase 2 trial. This study is designed to asses response rate and defined as the percentage of subjects achieving at least 50% tumor volume. One-sided alpha is set at no more than 5% and the power no less than 90%,and the null hypothesis of RR of less than 10% and alternative hypothesis of RR of greater than 30%, a total of 30 patients will be enrolled (Fleming 1982).At least 7 responders out of 30 patients are needed to reject the null hypothesis of a 10% RR.||||<0.01
73922263|NCT00385996|147372434|OTHER||TTP [% without disease at 24 months]|63.6|||||TWO_SIDED|95.0|43.4|83.8|||||Using the Kaplan-Meier method.|One arm study||83.8|43.4|
73971404|NCT04508309|147483471|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.78|||||TWO_SIDED|98.3|1.455|2.176|||||GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% CI was used.||2.176|1.455|
74028326|NCT02075255|147610260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.004|TWO_SIDED|95.0|0.14|0.76|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.||||0.76|0.14|0.004
74028327|NCT02075255|147610261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.538||||0.22|TWO_SIDED|95.0|0.773|3.06|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.||||3.060|0.773|0.220
73922264|NCT00385996|147372435|OTHER||% alive without disease at 25 months|72.7|||||TWO_SIDED|95.0|54.1|91.3|||||Using the Kaplan-Meier method.|One arm study||91.3|54.1|
73922265|NCT04249310|147372439|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.32|2.46|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox-regression was used to estimate the hazard ratios and 95% confidence intervals.|||2.46|0.32|
73922266|NCT04249310|147372440|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.63|1.15|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Moderate or Severe COPD Exacerbation||1.15|0.63|
73922267|NCT04249310|147372440|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.43|1.01|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Moderate COPD Exacerbation||1.01|0.43|
73922268|NCT04249310|147372440|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.62|1.31|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Severe COPD Exacerbation||1.31|0.62|
74086841|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.65|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|2.36|8.94||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||8.94|2.36|
73922269|NCT02707991|147372458|SUPERIORITY||Mean Difference (Final Values)|22.0|STANDARD_ERROR_OF_MEAN|0.115||0.036|ONE_SIDED|||||one-sided test|z-test for difference in proportions|||||||0.036
73922270|NCT02733991|147372460|SUPERIORITY||Mean Difference (Final Values)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.51|-2.25|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm|||-2.25|-3.51|<0.0001
73922271|NCT02733991|147372461|SUPERIORITY||Mean Difference (Final Values)|-42.62|||<|0.0001|TWO_SIDED|95.0|-52.01|-33.19|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm|||-33.19|-52.01|<0.0001
73922272|NCT02733991|147372462|NON_INFERIORITY|Non-inferiority margin of 40 min/day|Mean Difference (Final Values)|-38.8|||||ONE_SIDED|97.5||-0.46|||||Model based Estimated mean; difference = control arm - treatment arm|||-0.46||
73922273|NCT02733991|147372462|SUPERIORITY||Mean Difference (Final Values)|38.8||||0.0474|TWO_SIDED|95.0|0.46|77.11|||Mixed Models Analysis||Model based Estimated mean; Difference = Treatment arm - Control arm|||77.11|0.46|0.0474
73922274|NCT04191499|147372463|SUPERIORITY||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.32|0.59|||Log Rank|||Hazard ratios were estimated by Cox regression. Hazard ratios and log-rank p-values are using stratified methods by stratifying Visceral Disease, Endocrine Resistance, and Region.||0.59|0.32|<0.0001
73922275|NCT02141997|147372477|SUPERIORITY_OR_OTHER||||||=|0.863|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.863
73922276|NCT02141997|147372477|SUPERIORITY_OR_OTHER||||||=|0.414|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.414
73922277|NCT02141997|147372477|SUPERIORITY_OR_OTHER||||||=|0.196|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.196
73922278|NCT04105998|147372488|SUPERIORITY|Exploratory analysis without power calculation||||||0.64|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.64
73922279|NCT04105998|147372489|SUPERIORITY|Exploratory analysis without power calculation||||||0.19|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.19
73922280|NCT04105998|147372490|SUPERIORITY|Exploratory analysis without power calculation||||||0.067|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.067
73922281|NCT04105998|147372491|SUPERIORITY|Exploratory analysis without power calculation||||||0.25|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.25
73922282|NCT04105998|147372492|SUPERIORITY|Exploratory analysis without power calculation||||||0.058|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.058
73922283|NCT04105998|147372493|SUPERIORITY|Exploratory analysis without power calculation||||||0.111|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.111
73922284|NCT00416078|147372513|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||F test of time X group effect F(1,3)=.26|Mixed Models Analysis|||intent to treat||||.65
73922285|NCT00416078|147372514|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|||||t test of differential change over time in the two groups t(30)=.67|Mixed Models Analysis|||intent to treat analysis||||.51
73922286|NCT00416078|147372515|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|||||t test of differential change over time in the two groups t(29)=.27|Mixed Models Analysis|||intent to treat analysis||||.79
73922287|NCT00416078|147372516|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||t test for differential change over time in the two groups t(29)=.70|Mixed Models Analysis|||intent to treat analysis||||.49
73922288|NCT00416078|147372517|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||t test for differential change over time in the two groups t(29)=.43|Mixed Models Analysis|||intent to treat analysis||||.67
73922289|NCT00416078|147372518|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Fisher Exact|||||||.64
74028328|NCT02075255|147610261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.783||||0.108|TWO_SIDED|95.0|0.882|3.605|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.||||3.605|0.882|0.108
74028329|NCT02075255|147610265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-162.2|||<|0.001|TWO_SIDED|95.0|-220.1|-104.3|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit|Percent change|||-104.3|-220.1|<0.001
74028330|NCT02075255|147610265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-159.4|||<|0.001|TWO_SIDED|95.0|-217.9|-100.9|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit.|Percent change|||-100.9|-217.9|<0.001
73922290|NCT01698801|147372540|SUPERIORITY_OR_OTHER||Overall dichotomized response rate|87.5|||<|0.0001|TWO_SIDED|95.0|74.269|100.0||One sample binomial test for the overall response rate was performed to provide p-value (significance level: 0.05) based on EE population. The hypotheses of interest are: H0: p = 0.3, H1: p ≠ 0.3, where p is overall response.|Binomial test for dichotomized response|||||100|74.269|<0.0001
73922291|NCT03761147|147372546|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73922292|NCT03232281|147372563|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was confirmed.|Rate difference (%)|-0.7|||||TWO_SIDED|95.0|-4.41|2.58|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||2.58|-4.41|
73922293|NCT03232281|147372564|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-1.3|||||TWO_SIDED|95.0|-5.26|1.93|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.93|-5.26|
73967697|NCT03761537|147472943|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|15.6||||0.005|TWO_SIDED|95.0|4.8|26.3||This endpoint was the fifth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||26.3|4.8|0.005
74028331|NCT01088412|147610271|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.77|||||TWO_SIDED|95.0|2.24|5.96||||||Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.||5.96|2.24|
74028332|NCT01088412|147610272|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.71|||||TWO_SIDED|95.0|0.39|1.2||||||Epidemiological comparison between incidence of primary malignancies in study versus general population registry data, stratified by age and gender.||1.20|0.39|
74028333|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.03|||||TWO_SIDED|95.0|2.14|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All DM (T1, T2 and DM Not Otherwise Specified \[NOS\] Combined)"||4.15|2.14|
74028334|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|2.74|||||TWO_SIDED|95.0|1.72|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD DM (T1, T2 and DM NOS Combined)"||4.15|1.72|
74028335|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|4.91|||||TWO_SIDED|95.0|1.8|10.69||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS DM (T1, T2 and DM NOS Combined)"||10.69|1.80|
74086842|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.44|STANDARD_ERROR_OF_MEAN|1.68|||TWO_SIDED|95.0|0.12|6.75||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||6.75|0.12|
74028336|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.1|||||TWO_SIDED|95.0|0.84|7.93||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS DM (T1, T2 and DM NOS Combined)"||7.93|0.84|
74028337|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|11.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D DM (T1, T2 and DM NOS Combined)"||11.83|0.00|
74028338|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.0|||||TWO_SIDED|95.0|0.36|10.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA DM (T1, T2 and DM NOS Combined)"||10.83|0.36|
74028339|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|4.55|||||TWO_SIDED|95.0|1.24|11.66||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other DM (T1, T2 and DM NOS Combined)"||11.66|1.24|
74028340|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|24.3||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown DM (T1, T2 and DM NOS Combined)"||24.30|0.00|
74028341|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.92|||||TWO_SIDED|95.0|0.56|1.44||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T1 DM."||1.44|0.56|
73861613|NCT01515475|147269158|OTHER||Mean Difference (Final Values)|0.6||||0.002|TWO_SIDED|99.0|0.11|1.09||Results are considered statistically significant if p\<0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||1.09|0.11|0.002
73861614|NCT01515475|147269158|OTHER||Mean Difference (Final Values)|0.58||||0.002|TWO_SIDED|99.0|0.1|1.06||Results are considered statistically significant if p\<0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||1.06|0.10|0.002
73861615|NCT01515475|147269158|OTHER||Mean Difference (Final Values)|0.16||||0.53|TWO_SIDED|99.0|-0.51|0.84||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||0.84|-0.51|0.53
73861616|NCT01515475|147269158|OTHER||Mean Difference (Final Values)|0.22||||0.38|TWO_SIDED|99.0|-0.43|0.86||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||0.86|-0.43|0.38
73861617|NCT01515475|147269159|OTHER||Mean Difference (Final Values)|-25.0||||0.013|TWO_SIDED|99.0|-49.0|1.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||"Analysis for the more hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups."||1|-49|0.013
73861618|NCT01515475|147269159|OTHER||Hazard Ratio, log|-18.0||||0.08|TWO_SIDED|99.0|-42.0|8.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||"Analysis for the less hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups."||8|-42|0.08
73861619|NCT01515475|147269160|OTHER||Mean Difference (Final Values)|0.01||||0.22|TWO_SIDED|99.0|-0.02|0.04|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.04|-0.02|0.22
73861620|NCT01515475|147269160|OTHER||Mean Difference (Final Values)|-0.02||||0.41|TWO_SIDED|99.0|-0.06|0.03|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.03|-0.06|0.41
73861621|NCT01515475|147269160|OTHER||Mean Difference (Final Values)|-0.05||||0.02|TWO_SIDED|99.0|-0.12|0.01|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.01|-0.12|0.02
73861622|NCT01515475|147269160|OTHER||Mean Difference (Final Values)|-0.07||||0.15|TWO_SIDED|99.0|-0.19|0.05|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.05|-0.19|0.15
73861623|NCT01515475|147269161|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||13|-18|0.51
73861624|NCT01515475|147269161|OTHER||Mean Difference (Final Values)|-2.0||||0.79|TWO_SIDED|99.0|-18.0|14.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||14|-18|0.79
73861625|NCT01515475|147269162|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||13|-18|0.51
73861626|NCT01515475|147269162|OTHER||Mean Difference (Final Values)|-4.0||||0.68|TWO_SIDED|99.0|-24.0|16.0||Results are considered statistically significant if p≤0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||16|-24|0.68
73861627|NCT01515475|147269163|OTHER||Mean Difference (Final Values)|-0.04||||0.21|TWO_SIDED|99.0|-0.12|0.05||Results are considered statistically significant if p\<0.01|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.||0.05|-0.12|0.21
73861628|NCT01515475|147269163|OTHER||Mean Difference (Final Values)|-0.03||||0.25|TWO_SIDED|99.0|-0.1|0.04||Results are considered statistically significant if p≤0.01.|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.||0.04|-0.10|0.25
73861629|NCT01515475|147269164|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups||13|-18|0.51
73861630|NCT01515475|147269164|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|99.0|-17.0|17.0||No p-value, because there was 0% difference||||Barnard's exact test used to compare proportions between treatment groups.||17|-17|
73861631|NCT01515475|147269165|OTHER||Mean Difference (Final Values)|0.02||||0.74|TWO_SIDED|99.0|-0.11|0.14||Results are considered statistically significant if p\<0.01.|ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit, anisometropia at the most recent visit, and stereoacuity at enrollment.||0.14|-0.11|0.74
73861632|NCT01515475|147269165|OTHER||Mean Difference (Final Values)|-0.1||||0.15|TWO_SIDED|99.0|-0.4|0.1|||ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit and anisometropia at the most recent visit.||0.1|-0.4|0.15
73861633|NCT01515475|147269166|OTHER||Mean Difference (Final Values)|5.0||||0.53|TWO_SIDED|99.0|-14.0|26.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups||26|-14|0.53
73861634|NCT01515475|147269166|OTHER||Mean Difference (Final Values)|-19.0||||0.02|TWO_SIDED|99.0|-40.0|2.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups.||2|-40|0.02
73861635|NCT01511809|147269195|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A lower limit of the 95% confidence interval of the difference between the two proportions of treatment failure (triple therapy-monotherapy) below the pre-specified margin of non-inferiority of -10% established inferiority. A sample size of 342 patients (171 per treatment arm) provided 80% power (one-sided, alpha 0.05) to establish non-inferiority of ATV/r monotherapy as compared to ATV/r triple therapy with an overall treatment failure (TF) rate of 15% at week 48.|difference between TF proportions|15.0|||||TWO_SIDED|||||||||"Here are reported the results of the 48-week interim analyses according to the intention-to-treat (ITT) principle. ITT=F (with re-intensification=failure) and the ITT=S (with re-intensification=success) treatment failure results are shown.~Based on the efficacy data review, in June 2013, an independent Data and Safety Monitoring Board (DSMB) recommended to stop further patients' enrolment and to follow-up the enrolled patients until 96 weeks, after having signed an updated informed consent."||||
73922294|NCT03232281|147372564|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-2.7|||||TWO_SIDED|95.0|-6.8|-0.16|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||-0.16|-6.80|
73922295|NCT03232281|147372565|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-1.3|||||TWO_SIDED|95.0|-5.26|1.93|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.93|-5.26|
73922296|NCT03232281|147372565|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-4.1|||||TWO_SIDED|95.0|-8.93|-0.52|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||-0.52|-8.93|
73922297|NCT03232281|147372565|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-2.7|||||TWO_SIDED|95.0|-7.44|1.17|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 12. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.17|-7.44|
73922298|NCT02132767|147372572|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
73922299|NCT02132767|147372573|SUPERIORITY_OR_OTHER|||||||0.003|||||||Log Rank|||||||0.003
73922300|NCT02132767|147372574|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|||||||0.14
73922301|NCT02132767|147372575|SUPERIORITY_OR_OTHER|||||||0.71|||||||Chi-squared|||||||0.71
73861636|NCT00130923|147269197|SUPERIORITY||difference in treatment slopes|-0.043|STANDARD_ERROR_OF_MEAN|0.021||0.054|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment slopes in a mixed model and its standard error.|||||0.054
73922302|NCT02132767|147372576|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
73922303|NCT02132767|147372577|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
73967698|NCT03761537|147472944|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.1||||0.014|TWO_SIDED|95.0|2.9|25.3||This endpoint was the sixth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.3|2.9|0.014
73922304|NCT02132767|147372578|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
73922305|NCT02132767|147372579|SUPERIORITY_OR_OTHER|||||||0.73|||||||Regression, Poisson|||||||0.73
73922306|NCT00778700|147372592|SUPERIORITY||Least Squares (LS) Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.406||0.0041|TWO_SIDED|90.0|-1.85|-0.51|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.51|-1.85|0.0041
73922307|NCT00778700|147372592|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.408||0.0007|TWO_SIDED|90.0|-2.08|-0.73|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.73|-2.08|0.0007
73922308|NCT00778700|147372592|SUPERIORITY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.407||0.0035|TWO_SIDED|90.0|-1.88|-0.53|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.53|-1.88|0.0035
73922309|NCT04008030|147372621|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.62||||0.0003|TWO_SIDED|95.0|0.48|0.81||Boundary for statistical significance p-value \< 0.0095.|Log Rank|Log-rank test stratified by the same factors as used in the Cox proportional hazard model.|a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.81|0.48|0.0003
73922310|NCT04008030|147372622|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.14|0.32||Boundary for statistical significance p-value \< 0.0209.|Log Rank|Log-rank test stratified by the same factors as used in the Cox proportional hazard model.|From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.|||0.32|0.14|<0.0001
73922311|NCT04008030|147372624|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.52|0.79|||||from a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.79|0.52|
73922312|NCT04008030|147372625|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.32|||||TWO_SIDED|95.0|0.23|0.46|||||From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.|||0.46|0.23|
73922313|NCT04008030|147372627|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.6||||||95.0|0.45|0.8|||||from a Cox proportional hazard model stratified by tumor sidedness (left vs right) and prior lines of therapy (0, 1, ≥ 2) per IRT.|||0.80|0.45|
73922314|NCT04008030|147372628|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.63||||||95.0|0.48|0.83|||||from a Cox proportional hazard model stratified by tumor sidedness (left vs right) and prior lines of therapy (0, 1, ≥ 2) per IRT.|||0.83|0.48|
73922315|NCT04008030|147372629|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.2||||||95.0|0.12|0.31|||||From a stratified Cox proportional hazard model by tumor sidedness (left vs. right) as entered into the IRT.|||0.31|0.12|
73922316|NCT04008030|147372630|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.2||||||95.0|0.12|0.31|||||From a stratified Cox proportional hazard model by tumor sidedness (left vs. right) as entered into the IRT.|||0.31|0.12|
73922317|NCT04008030|147372631|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.64||||||95.0|0.52|0.79|||||from a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.79|0.52|
73922318|NCT04008030|147372632|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.62||||||95.0|0.48|0.8|||||Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.80|0.48|
73922319|NCT04008030|147372634|SUPERIORITY|Arm B over Arm A|Odds Ratio (OR)|1.77||||0.0011||95.0|1.26|2.5||Boundary for statistical significance p-value \< 0.006|Cochran-Mantel-Haenszel|Two-sided p-value from stratified CMH Test.|||Stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT|2.50|1.26|0.0011
73922320|NCT04008030|147372635|SUPERIORITY|Arm B over Arm C|Odds Ratio (OR)|7.02||||||95.0|3.91|12.62|||||Stratified by tumor sidedness (left vs. right)|||12.62|3.91|
73922321|NCT04008030|147372635|SUPERIORITY|Arm B over Arm A|Odds Ratio (OR)|1.67||||||95.0|1.06|2.63|||||Stratified by tumor sidedness (left vs. right)|||2.63|1.06|
73922322|NCT04008030|147372636|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.45|0.83|||||From a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.83|0.45|
73922323|NCT01304966|147372643|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 1 sided|||||||0.013
73922324|NCT00003901|147372647|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.59||||0.007|TWO_SIDED|95.0|1.13|2.23|||Regression, Cox|||||2.23|1.13|0.007
73922325|NCT00003901|147372648|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.886|TWO_SIDED|95.0|0.69|1.54|||Regression, Cox|||||1.54|0.69|0.886
73922326|NCT00003901|147372649|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.63||||0.009|TWO_SIDED|95.0|1.13|2.36|||Regression, Cox|||||2.36|1.13|0.009
73922327|NCT00003901|147372650|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.78||||0.332|TWO_SIDED|95.0|0.48|1.28|||Regression, Cox|||||1.28|0.48|0.332
73971405|NCT04508309|147483471|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|2.37|||||TWO_SIDED|98.3|1.942|2.903|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.903|1.942|
73967699|NCT03761537|147472945|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|7.3||||0.228|TWO_SIDED|95.0|-4.6|19.2||This endpoint was the seventh endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|HaenszMantelel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||19.2|-4.6|0.228
73861637|NCT00130923|147269198|SUPERIORITY||Difference in treatment means|-0.62|STANDARD_ERROR_OF_MEAN|0.29||0.035|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.035
73861638|NCT00130923|147269199|SUPERIORITY||difference in treatment means|0.056|STANDARD_ERROR_OF_MEAN|0.099||0.57|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.57
73861639|NCT00130923|147269200|SUPERIORITY||difference in treatment means|2.65|STANDARD_ERROR_OF_MEAN|2.68||0.32|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient difference in treatment means in a mixed model and its standard error.|||||.32
73861640|NCT00130923|147269201|SUPERIORITY||difference in treatment means|0.93|STANDARD_ERROR_OF_MEAN|1.19||0.44|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.44
73861641|NCT00130923|147269202|SUPERIORITY|||||||0.003|||||||Chi-squared|Statistical test of hypothesis. Value of the Chi-squared statistic is 9.08||||||.003
73861642|NCT04557787|147269206|SUPERIORITY||Mean Difference (Final Values)|28.4||||0.001|TWO_SIDED|95.0|12.2|44.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||44.6|12.2|0.001
73861643|NCT04557787|147269206|SUPERIORITY||Mean Difference (Final Values)|28.2||||0.001|TWO_SIDED|95.0|12.0|44.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||44.4|12.0|0.001
73861644|NCT04557787|147269206|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.983|TWO_SIDED|95.0|-16.0|16.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||16.3|-16.0|0.983
73861645|NCT04557787|147269207|SUPERIORITY||Mean Difference (Final Values)|33.2|||<|0.001|TWO_SIDED|95.0|17.0|49.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.4|17.0|<0.001
73861646|NCT04557787|147269207|SUPERIORITY||Mean Difference (Final Values)|29.7|||<|0.001|TWO_SIDED|95.0|13.5|46.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||46.0|13.5|<0.001
73861647|NCT04557787|147269207|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.667|TWO_SIDED|95.0|-12.6|19.7||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||19.7|-12.6|0.667
73861648|NCT04557787|147269208|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.503|TWO_SIDED|95.0|-14.2|7.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||7.0|-14.2|0.503
73861649|NCT04557787|147269208|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.916|TWO_SIDED|95.0|-10.1|11.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||11.2|-10.1|0.916
73861650|NCT04557787|147269208|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.438|TWO_SIDED|95.0|-14.8|6.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied||6.5|-14.8|0.438
73861651|NCT04557787|147269209|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.955|TWO_SIDED|95.0|-10.3|10.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||10.9|-10.3|0.955
73922328|NCT00527943|147372668|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.92||||0.072|TWO_SIDED|95.0|0.85|1.01|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.01|0.85|0.072
73922329|NCT00527943|147372669|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.018|TWO_SIDED|95.0|0.81|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.81|0.018
73922330|NCT00527943|147372670|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.36|||<|0.001|TWO_SIDED|95.0|1.18|1.57|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.57|1.18|<0.001
73922331|NCT00527943|147372671|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.41|||<|0.001|TWO_SIDED|95.0|1.29|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.54|1.29|<0.001
73922332|NCT00527943|147372672|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.038|TWO_SIDED|95.0|0.84|1.0|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.00|0.84|0.038
73922333|NCT00527943|147372673|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.027|TWO_SIDED|95.0|0.81|0.99|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.99|0.81|0.027
73922334|NCT00527943|147372674|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.94||||0.174|TWO_SIDED|95.0|0.87|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.87|0.174
73922335|NCT00527943|147372675|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.108|TWO_SIDED|95.0|0.86|1.02|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.02|0.86|0.108
73922336|NCT00527943|147372676|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.963|TWO_SIDED|95.0|0.83|1.22|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.22|0.83|0.963
73922337|NCT00527943|147372677|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.021|TWO_SIDED|95.0|0.79|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.79|0.021
73922338|NCT00527943|147372678|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.418|TWO_SIDED|95.0|0.83|1.58|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.58|0.83|0.418
73922339|NCT00527943|147372679|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.07||||0.493|TWO_SIDED|95.0|0.88|1.31|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.31|0.88|0.493
73931043|NCT05569954|147391863|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|2.92|||<|0.001||95.0|2.5|3.42||1-sided|cLDA model||V116/PPSV23|Serotype 15C: V116/PPSV23 GMT Ratio||3.42|2.50|<0.001
74086843|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|1.85|||TWO_SIDED|95.0|-0.06|7.25||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.25|-0.06|
74086844|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.65|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|0.86|8.44||||||Change from baseline at Month 33 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||8.44|0.86|
73922340|NCT00527943|147372680|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.05||||0.515|TWO_SIDED|95.0|0.9|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.23|0.90|0.515
73922341|NCT00527943|147372681|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.606|TWO_SIDED|95.0|0.7|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.23|0.70|0.606
73922342|NCT00598663|147372712|SUPERIORITY||Mean Difference (Final Values)|0.43|||<|0.0001|ONE_SIDED|97.5|||||ANCOVA|ANOVA with adjustment for period effect and subject as random effect. Period was included in the model regardless of statistical significance.||||||<0.0001
73922343|NCT03742037|147372732|SUPERIORITY||LS mean difference to placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.54||0.4749|TWO_SIDED|95.0|-1.45|0.68|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||0.68|-1.45|0.4749
73922344|NCT03742037|147372732|SUPERIORITY||LS mean to placebo|-0.57|STANDARD_ERROR_OF_MEAN|0.54||0.2941|TWO_SIDED|95.0|-1.65|0.49|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||0.49|-1.65|0.2941
73922345|NCT03742037|147372732|SUPERIORITY||LS mean difference to placebo|0.01|STANDARD_ERROR_OF_MEAN|0.54||0.9802|TWO_SIDED|95.0|-1.05|1.08|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||1.08|-1.05|0.9802
73922346|NCT03742037|147372732|SUPERIORITY||LS mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.54||0.0291|TWO_SIDED|95.0|-2.25|-0.12|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||-0.12|-2.25|0.0291
73922347|NCT03742037|147372733|SUPERIORITY||Odds Ratio (OR)|1.01||||0.974|TWO_SIDED|95.0|0.54|1.9|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||1.9|0.54|0.974
73922348|NCT03742037|147372733|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2845|TWO_SIDED|95.0|0.75|2.65|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.65|0.75|0.2845
73922349|NCT03742037|147372733|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5115|TWO_SIDED|95.0|0.66|2.32|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.32|0.66|0.5115
73922350|NCT03742037|147372733|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5115|TWO_SIDED|95.0|0.66|2.32|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.32|0.66|0.5115
73922351|NCT01857232|147372779|SUPERIORITY|||||||0.004|||||||Regression, Logistic|||||||0.004
73922352|NCT01857232|147372779|SUPERIORITY|||||||0.0987|||||||Regression, Logistic|||||||0.0987
73922353|NCT01857232|147372779|SUPERIORITY|||||||0.1041|||||||Regression, Logistic|||||||0.1041
73922354|NCT01857232|147372780|SUPERIORITY|||||||0.0235|||||||Chi-squared, Corrected|1-sided||||||0.0235
74086845|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.85|STANDARD_ERROR_OF_MEAN|1.94|||TWO_SIDED|95.0|0.02|7.68||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.68|0.02|
73922355|NCT01857232|147372780|SUPERIORITY|||||||0.1651|||||||Chi-squared, Corrected|1-sided||||||0.1651
73922356|NCT01857232|147372780|SUPERIORITY|||||||0.1332|||||||Chi-squared, Corrected|1-sided||||||0.1332
73922357|NCT00969150|147372783|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.49||||0.2492|TWO_SIDED|95.0|-4.02|1.05|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||1.05|-4.02|0.2492
73922358|NCT00969150|147372784|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.54||||0.5625|TWO_SIDED|95.0|-2.38|1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||1.29|-2.38|0.5625
73931044|NCT05569954|147391863|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|4.5|||<|0.001|TWO_SIDED|95.0|3.99|5.09||1-sided|cLDA model||V116/PPSV23|Serotype 16F: V116/PPSV23 GMT Ratio||5.09|3.99|<0.001
73931045|NCT05569954|147391863|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|5.74|||<|0.001|TWO_SIDED|95.0|4.81|6.85||1-sided|cLDA model||V116/PPSV23|Serotype 23A: V116/PPSV23 GMT Ratio||6.85|4.81|<0.001
73931046|NCT05569954|147391863|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|16.42|||<|0.001|TWO_SIDED|95.0|13.46|20.03||1-sided|cLDA model||V116/PPSV23|Serotype 23B: V116/PPSV23 GMT Ratio||20.03|13.46|<0.001
74086846|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|2.31|||TWO_SIDED|90.0|0.08|9.25||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||9.25|0.08|
73861652|NCT04557787|147269209|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.118|TWO_SIDED|95.0|-19.2|2.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||2.2|-19.2|0.118
73861653|NCT04557787|147269209|SUPERIORITY||Mean Difference (Final Values)|8.8||||0.104|TWO_SIDED|95.0|-1.8|19.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||19.5|-1.8|0.104
73922359|NCT03204305|147372806|SUPERIORITY||t-test|-2.51||||0.02|TWO_SIDED|||||p \< 0.05 for all analyses. Bonferroni corrections were made to reduce family-wise error rate.|t-test, 2 sided|Composite VT was compared using independent t-tests.||VT in the 8 volumes of interest were analyzed using linear regression model group coded encoded as a dummy variable \[1=females cannabis users; 2= female healthy controls\], age as a covariate, and VT for VOIs (ventral striatum, amygdala, putamen, cingulate, globus pallidus, insula, frontal cortex, and hippocampus) as dependent variables, followed by post hoc Tukey's HSD between between groups.||||0.02
73922360|NCT03204305|147372806|SUPERIORITY||t-test|-2.36||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
73922361|NCT03204305|147372806|SUPERIORITY||t-test|-2.35||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
73922362|NCT03204305|147372806|SUPERIORITY||t-test|-2.23||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
73922363|NCT03204305|147372807|SUPERIORITY||t test|-2.52||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
74086847|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-1.82|10.07||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||10.07|-1.82|
73861654|NCT04557787|147269210|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.352|TWO_SIDED|95.0|-0.22|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-0.22|0.352
73861655|NCT04557787|147269210|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.98|TWO_SIDED|95.0|-0.41|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-0.41|0.980
74086848|NCT01115855|147727553|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|0.56|5.8||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||5.80|0.56|
74086849|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-61.53|STANDARD_ERROR_OF_MEAN|59.75|||TWO_SIDED|95.0|-186.44|63.37||||||Change from baseline at Month 5: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||63.37|-186.44|
73922364|NCT00735787|147372856|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Fisher Exact|||The primary null hypothesis for this study was that there was no difference in the proportion of subjects that achieved PGA clear or almost clear at Week 16 between the adalimumab and placebo groups. Analysis was done using a two-sided Fisher's exact test at alpha level=0.05.||||0.014
73922365|NCT01566461|147372889|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||z-test|||||||<0.001
73922366|NCT01566461|147372890|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73922367|NCT01566461|147372891|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73922368|NCT01566461|147372892|SUPERIORITY_OR_OTHER|||||||0.926|TWO_SIDED||||||Chi-squared|||||||0.926
73922369|NCT01566461|147372893|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73922370|NCT01566461|147372894|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73922371|NCT01566461|147372895|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||t-test, 1 sided|||||||0.859
73922372|NCT01566461|147372896|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
73922373|NCT01566461|147372897|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED||||||Chi-squared|||||||0.096
73922374|NCT01566461|147372898|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73922375|NCT01566461|147372899|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED||||||Chi-squared|||||||0.121
73922376|NCT01566461|147372900|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
73922377|NCT01566461|147372901|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73922378|NCT01566461|147372902|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||t-test, 1 sided|||||||0.095
73922379|NCT01566461|147372903|SUPERIORITY_OR_OTHER|||||||0.878|TWO_SIDED||||||t-test, 1 sided|||||||0.878
73922380|NCT01566461|147372904|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 1 sided|||||||0.590
73922381|NCT01566461|147372905|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED||||||Chi-squared|||||||0.302
73922382|NCT01566461|147372906|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED||||||Chi-squared|||||||0.111
73922383|NCT01566461|147372907|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Chi-squared|||||||0.103
73922384|NCT01566461|147372908|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||t-test, 1 sided|||||||0.049
73922385|NCT04958785|147372930|SUPERIORITY||Hazard Ratio (HR)|0.456||||0.1617|TWO_SIDED|95.0|0.147|1.409|||Log Rank||Hazard Ratio (HR) along with its 2-sided 95% confidence interval (CI) were estimated using the Cox proportional hazards regression model.|||1.409|0.147|0.1617
74086850|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.94|STANDARD_ERROR_OF_MEAN|54.2|||TWO_SIDED|95.0|-131.27|81.39||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||81.39|-131.27|
73922386|NCT04958785|147372932|SUPERIORITY||Odds Ratio (OR)|2.037|||||TWO_SIDED|95.0|0.379|10.938|||||Odds ratios and corresponding 95% CIs were estimated using chi-square test.|||10.938|0.379|
73861656|NCT04557787|147269210|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.339|TWO_SIDED|95.0|-0.21|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-0.21|0.339
73861657|NCT04557787|147269211|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.62|0.42||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.42|-0.62|0.700
73861658|NCT04557787|147269211|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.227|TWO_SIDED|95.0|-0.2|0.84||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.84|-0.20|0.227
73861659|NCT04557787|147269211|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.112|TWO_SIDED|95.0|-0.94|0.1||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.10|-0.94|0.112
73922387|NCT03274687|147372940|NON_INFERIORITY|The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -5.||||||0.98|||||||t-test, 1 sided|||Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 \< -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 90% power for this endpoint and 91% power for the bowel endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.||||0.98
73922388|NCT03274687|147372941|NON_INFERIORITY|The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -6.||||||0.96|||||||t-test, 1 sided|||Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 \< -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 91% power for this endpoint and 90% power for the urinary endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.||||0.96
73922389|NCT03274687|147372942|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||End of RT||||0.70
73922390|NCT03274687|147372942|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||6 months||||0.67
73922391|NCT03274687|147372942|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||1 year||||0.66
73861660|NCT04557787|147269212|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.013|TWO_SIDED|95.0|0.22|1.17||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.17|0.22|0.013
73922392|NCT03274687|147372943|SUPERIORITY|||||||0.0011|||||||t-test, 2 sided|||End of RT||||0.0011
73922393|NCT03274687|147372943|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||6 months||||0.93
73861661|NCT04557787|147269212|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.065|TWO_SIDED|95.0|-0.05|1.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.51|-0.05|0.065
73861662|NCT04557787|147269212|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.497|TWO_SIDED|95.0|-0.51|1.04||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.04|-0.51|0.497
73922394|NCT03274687|147372943|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||1 year||||0.30
73922395|NCT03274687|147372944|SUPERIORITY|||||||0.29|||||||Gray's test|Two-sided significance level 0.05||Protocol definition of biochemical failure||||0.29
73922396|NCT03274687|147372944|SUPERIORITY|||||||0.22|||||||Gray's test|Two-sided significance level 0.05||Phoenix definition of biochemical failure||||0.22
73922397|NCT03274687|147372945|SUPERIORITY|||||||0.96||||||Two-sided significance level 0.05|Gray's test|||||||0.96
73922398|NCT03274687|147372946|SUPERIORITY|||||||0.35||||||Two-sided significance level 0.05|Gray's test|||||||0.35
73922399|NCT03274687|147372947|SUPERIORITY|||||||0.41||||||Two-sided significance level 0.05|Gray's test|||||||0.41
73922400|NCT03274687|147372948|SUPERIORITY|||||||0.6||||||Two-sided significance level 0.05|Gray's test|||||||0.60
73922401|NCT03274687|147372950|SUPERIORITY||Hazard Ratio (HR)|1.58||||0.61|TWO_SIDED|95.0|0.26|9.47||Two-side significance level 0.05|Log Rank||Reference = COPORT|||9.47|0.26|0.61
73922402|NCT03274687|147372951|SUPERIORITY|||||||0.53|||||||Chi-squared|||Patients with any grade 3 or higher adverse event of any attribution||||0.53
73922403|NCT03274687|147372951|SUPERIORITY|||||||0.6929|||||||Chi-squared|||Patients with any grade 3 or higher gastrointestinal adverse event of any attribution||||0.6929
73922404|NCT03274687|147372951|SUPERIORITY|||||||0.2605|||||||Chi-squared|||Patients with any grade 3 or higher genitourinary adverse event of any attribution||||0.2605
73922405|NCT00594997|147372989|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||p\<0.05 threshold for statistical significance|Regression, Linear|||||||<0.0001
73922406|NCT05104476|147373004|SUPERIORITY||Bayesian Progression Model|0.81|||||TWO_SIDED|95.0|0.56|1.13|||||Reported here is the estimated effect parameter from the Bayesian Progression Model and the associated Credibility Interval for the active arm.|||1.13|0.56|
73922407|NCT04600414|147373038|SUPERIORITY||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.03|0.38|||Multi-level model to account for cluster|||||0.38|0.03|<0.001
73922408|NCT04600414|147373039|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.532|TWO_SIDED|95.0|-4.97|2.57|||Multi-level model to account for cluster|||||2.57|-4.97|0.532
73922409|NCT00531817|147373091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.85|||<|0.0001|TWO_SIDED|95.0|12.29|25.42||The p-value was not adjusted. The primary objective was a single comparison with an a priori threshold of 0.05 for statistical significance.|Fisher Exact|||Power calculation: Assuming placebo+DMARDs response rate of 15% and tocilizumab 8 mg/kg+DMARDs response rate of 28% based on previous trials, a sample size of 570 patients (2:1 ratio, tocilizumab+DMARDs n=380 and placebo+DMARDs n=190) will provide \> 90% power to detect a difference between 2 treatment arms with 5% Type I error with a 2-sided Fisher's exact test. Null Hypothesis: The percentage of patients responding in each treatment group (tocilizumab+DMARDs vs placebo+ DMARDs) is the same.||25.42|12.29|<0.0001
73922410|NCT03338855|147373101|SUPERIORITY||Least Square (LS) Mean Difference|-1.068|STANDARD_ERROR_OF_MEAN|1.014||0.3047|TWO_SIDED|95.0|-3.183|1.047|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta RD (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||1.047|-3.183|0.3047
73922411|NCT03338855|147373102|SUPERIORITY||LS Mean Difference|-1.705|STANDARD_ERROR_OF_MEAN|0.517||0.0036|TWO_SIDED|95.0|-2.784|-0.625|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta EGP (basal vs low insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.625|-2.784|0.0036
73922412|NCT03338855|147373102|SUPERIORITY||LS Mean Difference|-2.292|STANDARD_ERROR_OF_MEAN|0.409|<|0.0001|TWO_SIDED|95.0|-3.146|-1.438|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta EGP (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-1.438|-3.146|<0.0001
73922413|NCT03338855|147373103|SUPERIORITY||LS Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.009||0.1842|TWO_SIDED|95.0|-0.006|0.03|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta RER (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||0.030|-0.006|0.1842
73922414|NCT03338855|147373104|SUPERIORITY||LS Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.005||0.0001|TWO_SIDED|95.0|-0.033|-0.013|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of 24-hour RER between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.013|-0.033|0.0001
73922415|NCT03338855|147373105|SUPERIORITY||LS Mean Difference|-0.109|STANDARD_ERROR_OF_MEAN|0.065||0.1095|TWO_SIDED|95.0|-0.245|0.027|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of energy expenditure between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||0.027|-0.245|0.1095
73922416|NCT03338855|147373106|SUPERIORITY||LS Mean Difference|-246.7|STANDARD_ERROR_OF_MEAN|464.3||0.6005|TWO_SIDED|95.0|-1209.5|716.2|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of fat mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||716.2|-1209.5|0.6005
73922417|NCT03338855|147373106|SUPERIORITY||LS Mean Difference|-666.5|STANDARD_ERROR_OF_MEAN|301.1||0.0376|TWO_SIDED|95.0|-1291.0|-41.9|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of lean mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-41.9|-1291.0|0.0376
73922418|NCT03338855|147373107|SUPERIORITY||LS Mean Difference|-1.256|STANDARD_ERROR_OF_MEAN|0.289||0.0003|TWO_SIDED|95.0|-1.854|-0.657|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of total mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.657|-1.854|0.0003
73922419|NCT03338855|147373108|SUPERIORITY||LS Mean Difference|-244.301|STANDARD_ERROR_OF_MEAN|165.168||0.1555|TWO_SIDED|95.0|-590.002|101.401|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of FGF21 AUC between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||101.401|-590.002|0.1555
73922420|NCT02335099|147373116|SUPERIORITY||Odds Ratio (OR)|3.77||||0.32|TWO_SIDED|95.0|0.27|217.52|||Fisher Exact|||||217.52|0.27|0.32
73922421|NCT02335099|147373117|SUPERIORITY||Cox Proportional Hazard|0.86||||0.82|TWO_SIDED|95.0|0.23|3.2|||Log Rank|||||3.20|0.23|0.82
73922422|NCT02461225|147373118|SUPERIORITY||||||<|0.0005|||||||Fisher Exact|||||||<.0005
73922423|NCT02461225|147373119|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73922424|NCT00484939|147373120|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
73931047|NCT05569954|147391863|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|3.39|||<|0.001||95.0|2.97|3.87||1-sided|cLDA model||V116/PPSV23|Serotype 24F: V116/PPSV23 GMT Ratio||3.87|2.97|<0.001
74086851|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.57|STANDARD_ERROR_OF_MEAN|43.18|||TWO_SIDED|95.0|-97.28|72.13||||||Change from baseline at Month 13 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||72.13|-97.28|
74086852|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-78.47|STANDARD_ERROR_OF_MEAN|72.78|||TWO_SIDED|95.0|-221.25|64.31||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||64.31|-221.25|
73922425|NCT00484939|147373121|SUPERIORITY_OR_OTHER|||||||0.029|||||||Fisher Exact|||This statistical analysis compared the number of responders in the 2 treatment groups. A responder was defined as any participant with a best overall response of complete response or partial response. There were 28 responders in the bevacizumab + capecitabine group and 14 responders in the capecitabine group.||||0.029
73922426|NCT00484939|147373124|SUPERIORITY_OR_OTHER|||||||0.13|||||||Log Rank|||||||0.130
73922427|NCT01474876|147373139|SUPERIORITY_OR_OTHER|||||||0.0164|TWO_SIDED||||||Regression, Logistic|||Treatment response and participant age||||0.0164
73922428|NCT01474876|147373139|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0||||0.0200
73922429|NCT01474876|147373139|SUPERIORITY_OR_OTHER|||||||0.0867|TWO_SIDED||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0||||0.0867
73922430|NCT01474876|147373139|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Regression, Logistic|||Remission and participant age||||0.0001
73922431|NCT01474876|147373139|SUPERIORITY_OR_OTHER|||||||0.0734|TWO_SIDED||||||Regression, Logistic|||Remission and positive tuberculosis screening at Visit 0||||0.0734
73922432|NCT01474876|147373139|SUPERIORITY_OR_OTHER|||||||0.0438|TWO_SIDED||||||Regression, Logistic|||Remission and male gender||||0.0438
73922433|NCT01474876|147373139|SUPERIORITY_OR_OTHER|||||||0.503|TWO_SIDED||||||Regression, Logistic|||Remission and BASDAI score at Visit 0||||0.5030
73922434|NCT01474876|147373148|SUPERIORITY_OR_OTHER|||||||0.0576|TWO_SIDED||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0||||0.0576
74028342|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.76|||||TWO_SIDED|95.0|0.36|1.4||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T1DM."||1.40|0.36|
73922435|NCT01474876|147373148|SUPERIORITY_OR_OTHER|||||||0.1739|TWO_SIDED||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0||||0.1739
73922436|NCT01474876|147373148|SUPERIORITY_OR_OTHER|||||||0.0733|TWO_SIDED||||||Regression, Logistic|||Remission and Psoriasis at Visit 0||||0.0733
73922437|NCT01474876|147373148|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Regression, Logistic|||Remission and BASDAI at Visit 0||||0.5000
74028343|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|1.5|||||TWO_SIDED|95.0|0.31|4.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T1DM."||4.38|0.31|
74028344|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|1.42|||||TWO_SIDED|95.0|0.29|4.14||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T1DM."||4.14|0.29|
73922438|NCT02226003|147373206|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.49|-0.84|||Constrained Longitudinal Data Analysis|||||-0.84|-1.49|< 0.001
73922439|NCT02226003|147373206|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.24|||<|0.001|TWO_SIDED|95.0|-1.57|-0.91|||Constrained Longitudinal Data Analysis|||||-0.91|-1.57|< 0.001
73922440|NCT02226003|147373207|SUPERIORITY_OR_OTHER||Difference in Percentage vs Placebo|2.6|||||TWO_SIDED|95.0|-11.2|16.4||||||||16.4|-11.2|
73922441|NCT02226003|147373207|SUPERIORITY_OR_OTHER||Difference in Percentage vs Placebo|2.5|||||TWO_SIDED|95.0|-11.4|16.4||||||||16.4|-11.4|
73922442|NCT02226003|147373209|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-38.94|||<|0.001|TWO_SIDED|95.0|-49.93|-27.96|||Constrained Longitudinal Data Analysis|||||-27.96|-49.93|< 0.001
73922443|NCT02226003|147373209|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-46.05|||<|0.001|TWO_SIDED|95.0|-57.09|-35.02|||Constrained Longitudinal Data Analysis|||||-35.02|-57.09|< 0.001
73922444|NCT02226003|147373210|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-62.42|||<|0.001|TWO_SIDED|95.0|-80.47|-44.37|||Constrained Longitudinal Data Analysis|||||-44.37|-80.47|< 0.001
73922445|NCT02226003|147373210|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-69.65|||<|0.001|TWO_SIDED|95.0|-87.83|-51.46|||Constrained Longitudinal Data Analysis|||||-51.46|-87.83|< 0.001
73922446|NCT02226003|147373211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.88|||<|0.001|TWO_SIDED|95.0|2.81|16.83|||Logistic regression model|||||16.83|2.81|< 0.001
73922447|NCT02226003|147373211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.39|||<|0.001|TWO_SIDED|95.0|2.98|18.31|||Logistic regression model|||||18.31|2.98|< 0.001
73922448|NCT02226003|147373212|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.0|||<|0.001|TWO_SIDED|95.0|-2.99|-1.01|||Constrained Longitudinal Data Analysis|||||-1.01|-2.99|< 0.001
73922449|NCT02226003|147373212|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.1|||<|0.001|TWO_SIDED|95.0|-3.1|-1.11|||Constrained Longitudinal Data Analysis|||||-1.11|-3.10|< 0.001
73922450|NCT02226003|147373213|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-4.44||||0.011|TWO_SIDED|95.0|-7.87|-1.01|||Constrained Longitudinal Data Analysis|||||-1.01|-7.87|0.011
73922451|NCT02226003|147373213|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-6.39|||<|0.001|TWO_SIDED|95.0|-9.83|-2.95|||Constrained Longitudinal Data Analysis|||||-2.95|-9.83|< 0.001
73922452|NCT02226003|147373214|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.65||||0.184|TWO_SIDED|95.0|-4.09|0.79|||Constrained Longitudinal Data Analysis|||||0.79|-4.09|0.184
73922453|NCT02226003|147373214|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.18||||0.08|TWO_SIDED|95.0|-4.62|0.26|||Constrained Longitudinal Data Analysis|||||0.26|-4.62|0.080
73922454|NCT02467465|147373216|SUPERIORITY|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||||||0.175
73922455|NCT02467465|147373217|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.250
73922456|NCT02467465|147373218|SUPERIORITY|||||||0.466|||||||Wilcoxon (Mann-Whitney)|||||||0.466
73922457|NCT02467465|147373220|SUPERIORITY|||||||0.737|||||||Wilcoxon (Mann-Whitney)|||||||0.737
73922458|NCT02467465|147373221|SUPERIORITY|||||||0.275|||||||Wilcoxon (Mann-Whitney)|||||||0.275
73922459|NCT02467465|147373222|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
73922460|NCT02467465|147373224|SUPERIORITY|||||||0.849|||||||Wilcoxon (Mann-Whitney)|||||||0.849
74028345|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|7.23||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T1DM."||7.23|0.00|
73922461|NCT02467465|147373225|SUPERIORITY|||||||0.425|||||||Wilcoxon (Mann-Whitney)|||||||0.425
73922462|NCT02467465|147373226|SUPERIORITY|||||||0.487|||||||Wilcoxon (Mann-Whitney)|||||||0.487
73922463|NCT02467465|147373228|SUPERIORITY|||||||0.651|||||||t-test, 1 sided|||||||0.651
73922464|NCT02467465|147373229|SUPERIORITY|||||||0.387|||||||t-test, 1 sided|||||||0.387
73922465|NCT02467465|147373230|SUPERIORITY|||||||0.755|||||||t-test, 1 sided|||||||0.755
73922466|NCT02467465|147373232|SUPERIORITY|||||||0.032|||||||t-test, 1 sided|||||||0.032
73922467|NCT02467465|147373233|SUPERIORITY|||||||0.058|||||||t-test, 1 sided|||||||0.058
73922468|NCT02467465|147373234|SUPERIORITY|||||||0.279|||||||t-test, 1 sided|||||||0.279
73922469|NCT01499563|147373235|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.4||0.017|TWO_SIDED|95.0|-11.1|-0.4|||Mixed Effects model for Repeated Measure||95% CI for LS Mean difference are with Bonferroni correction|The study was powered for prespecified comparison of both doses of ITI-007 with placebo using a Bonferroni correction for multiple comparisons. The study was not statistically powered to include multiple comparisons of risperidone to placebo and thus, this comparison is not presented here.||-0.4|-11.1|0.017
73922470|NCT01499563|147373235|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|2.4||0.708|TWO_SIDED|95.0|-6.3|4.5|||Mixed Effects Model for Repeated Measure||95% CI for LS Mean difference are with Bonferroni correction|The study was powered for prespecified comparison of both doses of ITI-007 with placebo using a Bonferroni correction for multiple comparisons. The study was not statistically powered to include multiple comparisons of risperidone to placebo and thus, this comparison is not presented here.||4.5|-6.3|0.708
74028346|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|3.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T1DM."||3.38|0.00|
74028347|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio]|2.09|||||TWO_SIDED|95.0|0.43|6.1||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T1DM."||6.10|0.43|
74028348|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio]|0.0|||||TWO_SIDED|95.0|0.0|14.84||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T1DM."||14.84|0.00|
74028349|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.79|||||TWO_SIDED|95.0|2.24|5.96||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T2 DM."||5.96|2.24|
74028350|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.93|||||TWO_SIDED|95.0|2.03|6.87||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T2DM."||6.87|2.03|
74028351|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|6.46|||||TWO_SIDED|95.0|1.33|18.89||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T2DM."||18.89|1.33|
74028352|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|7.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T2DM."||7.52|0.00|
73922471|NCT00597012|147373248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4||||0.26|TWO_SIDED|95.0|-1.8|6.5|||ANCOVA|||"The primary analysis was implemented with an analysis of covariance with changes in the WOMAC physical-function score from baseline to 6 months as the dependent variable, treatment as the independent variable of interest, and study site as a covariate.~The primary analysis used a modified intention-to-treat approach in which patients who did not withdraw from the study were evaluated in the group to which they were randomly assigned."||6.5|-1.8|0.26
73922472|NCT00597012|147373249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.9||||0.16|TWO_SIDED|95.0|-1.2|7.0|||ANCOVA|||||7.0|-1.2|0.16
73922473|NCT00597012|147373250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.1||||0.68|TWO_SIDED|95.0|-4.4|6.6|||ANCOVA|||||6.6|-4.4|0.68
73922474|NCT00202644|147373286|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-100.5|STANDARD_ERROR_OF_MEAN|39.93|||TWO_SIDED|95.0|-179.42|-21.49||||||||-21.49|-179.42|
74028353|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|31.16||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T2DM."||31.16|0.00|
74028354|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|7.9|||||TWO_SIDED|95.0|0.96|28.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T2DM."||28.52|0.96|
74028355|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.0|||||TWO_SIDED|95.0|0.08|16.7||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T2DM."||16.70|0.08|
74028356|NCT01088412|147610279|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|63.97||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T2DM."||63.97|0.00|
74028357|NCT01208181|147610289|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-0.29||||0.004|TWO_SIDED|95.0|-0.49|-0.09|||Tukey-Ciminera-Heysetrend test|||||-0.09|-0.49|0.004
74028358|NCT01208181|147610289|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-0.27||||0.034|TWO_SIDED|95.0|-0.48|-0.06|||Tukey-Ciminera-Heysetrend test|||||-0.06|-0.48|0.034
74028359|NCT01208181|147610290|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-7.99|||<|0.001|TWO_SIDED|95.0|-11.85|-4.13|||Tukey-Ciminera-Heyse trend test|||||-4.13|-11.85|<0.001
73922475|NCT00202644|147373287|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-113.1|STANDARD_ERROR_OF_MEAN|37.56|||TWO_SIDED|95.0|-187.4|-38.83||||||Month 3||-38.83|-187.40|
73922476|NCT00202644|147373287|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-68.3|STANDARD_ERROR_OF_MEAN|43.83|||TWO_SIDED|95.0|-154.95|18.43||||||Month 36||18.43|-154.95|
73922477|NCT00951808|147373365|SUPERIORITY_OR_OTHER||optimal threshold level of sPLA2|48.0|STANDARD_DEVIATION|5.0|||TWO_SIDED|95.0|38.0|58.0|||||The optimal threshold level (TL) was determined to be the same for all analysis groups.|The optimal threshold level (TL), determined via receiver operating characteristic (ROC) curve analysis, maximizes the difference between the true positive rate (TPR) and the false positive rate (FPR). Since there is no corresponding analytic standard deviation (SD) for this value, we computed a robust SD based upon the interquartile range (IQR)/1.35 from a bootstrap sample of optimal TLs.||58|38|
73922478|NCT05247229|147373369|SUPERIORITY||Slope|0.37||||0.05|TWO_SIDED|95.0|0.0|0.73|||Chi-squared|||Q10 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.73|0.00|0.05
73922479|NCT05247229|147373369|SUPERIORITY||Slope|0.22||||0.36|TWO_SIDED|95.0|-0.25|0.7|||Chi-squared|||Q13 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.70|-0.25|0.36
73922480|NCT05247229|147373370|SUPERIORITY||Slope|-0.42||||0.12|TWO_SIDED|95.0|-0.96|0.11|||Chi-squared|||Q6 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.11|-0.96|0.12
73922481|NCT05247229|147373370|SUPERIORITY||Slope|0.41||||0.21|TWO_SIDED|95.0|-0.23|1.05|||Chi-squared|||Q7 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||1.05|-0.23|0.21
74028360|NCT01208181|147610290|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-10.7|||<|0.001|TWO_SIDED|95.0|-14.74|-6.66|||Tukey-Ciminera-Heyse trend test|||||-6.66|-14.74|<0.001
74086853|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-79.63|STANDARD_ERROR_OF_MEAN|67.42|||TWO_SIDED|95.0|-211.88|52.63||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||52.63|-211.88|
74086854|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|19.35|STANDARD_ERROR_OF_MEAN|88.95|||TWO_SIDED|95.0|-230.01|268.71||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||268.71|-230.01|
74086855|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.05|STANDARD_ERROR_OF_MEAN|88.27|||TWO_SIDED|95.0|-194.21|152.11||||||Change from baseline at Month 29: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||152.11|-194.21|
73922482|NCT05247229|147373370|SUPERIORITY||Slope|0.07||||0.78|TWO_SIDED|95.0|-0.41|0.54|||Chi-squared|||Q15 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.54|-0.41|0.78
73922483|NCT05247229|147373371|SUPERIORITY||Slope|0.51||||0.01|TWO_SIDED|95.0|0.16|0.86|||Chi-squared|||Q1 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.86|0.16|0.01
73922484|NCT05247229|147373371|SUPERIORITY||Slope|0.09||||0.67|TWO_SIDED|95.0|-0.34|0.52|||Chi-squared|||Q2 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.52|-0.34|0.67
73922485|NCT05247229|147373371|SUPERIORITY||Slope|0.13||||0.35|TWO_SIDED|95.0|-0.15|0.41|||Chi-squared|||Q3 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.41|-0.15|0.35
73922486|NCT05247229|147373371|SUPERIORITY||Slope|0.09||||0.73|TWO_SIDED|95.0|-0.43|0.61|||Chi-squared|||Q4 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.61|-0.43|0.73
73922487|NCT05247229|147373371|SUPERIORITY||Slope|0.2||||0.23|TWO_SIDED|95.0|-0.13|0.52|||Chi-squared|||Q5 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.52|-0.13|0.23
74028361|NCT01208181|147610291|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|0.02||||0.73|TWO_SIDED|95.0|-0.1|0.14|||Tukey-Ciminera-Heysetrend test|||||0.14|-0.10|0.730
74028362|NCT01208181|147610292|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-2.71||||0.019|TWO_SIDED|95.0|-4.98|-0.45|||Tukey-Ciminera-Heyse trend test|||||-0.45|-4.98|0.019
74028363|NCT01208181|147610293|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares mean|1.61||||0.327|TWO_SIDED|80.0|-0.49|3.71|||covariance model|||||3.71|-0.49|0.327
74028364|NCT01751646|147610383|OTHER|||||||0.1166||||||P-value from Wilcoxon rank sum test for change between baseline and Week 48 Vitamin D vs. Placebo|Wilcoxon (Mann-Whitney)|||||||0.1166
74028365|NCT01751646|147610385|OTHER|||||||0.8383|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.8383
73922488|NCT05247229|147373371|SUPERIORITY||Slope|0.71||||0|TWO_SIDED|95.0|0.27|1.15|||Chi-squared|||Q9 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||1.15|0.27|0.00
73922489|NCT05247229|147373371|SUPERIORITY||Slope|0.37||||0.05|TWO_SIDED|95.0|0.0|0.73|||Chi-squared|||Q10 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.73|0.00|0.05
73922490|NCT05247229|147373371|SUPERIORITY||Slope|0.37||||0.1|TWO_SIDED|95.0|-0.07|0.82|||Chi-squared|||Q11 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.82|-0.07|0.10
73922491|NCT05247229|147373371|SUPERIORITY||Slope|0.3||||0.32|TWO_SIDED|95.0|-0.3|0.91|||Chi-squared|||Q12 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.91|-0.30|0.32
73922492|NCT05247229|147373371|SUPERIORITY||Slope|0.22||||0.36|TWO_SIDED|95.0|-0.25|0.7|||Chi-squared|||Q13 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.70|-0.25|0.36
73967700|NCT03761537|147472946|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-8.9|||<|0.001|TWO_SIDED|95.0|-13.2|-4.6||This endpoint was the eighth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Unstructured covariance matrix. Adjusted for baseline SCORAD in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-4.6|-13.2|<0.001
73967701|NCT03761537|147472947|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-1.6||||0.005|TWO_SIDED|95.0|-2.7|-0.5||This endpoint was the ninth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Unstructured covariance matrix. Adjusted for baseline DLQI in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-0.5|-2.7|0.005
73967702|NCT03761537|147472948|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.3||||0.014|TWO_SIDED|95.0|2.9|25.6||This endpoint was the tenth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.6|2.9|0.014
74086856|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-40.79|STANDARD_ERROR_OF_MEAN|79.91|||TWO_SIDED|95.0|-197.55|115.97||||||Change from baseline at Month 33: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||115.97|-197.55|
73922493|NCT05247229|147373371|SUPERIORITY||Slope|0.35||||0.11|TWO_SIDED|95.0|-0.07|0.78|||Chi-squared|||Q14 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.78|-0.07|0.11
73922494|NCT02472795|147373374|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.39|TWO_SIDED|95.0|-0.56|0.22|||ANCOVA|||||0.22|-0.56|0.39
73922495|NCT02472795|147373374|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.02|TWO_SIDED|95.0|-0.91|0.09|||ANCOVA|||||0.09|-0.91|0.02
73922496|NCT02472795|147373374|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.95|-0.19|||ANCOVA|||||-0.19|-0.95|0.004
73922497|NCT02472795|147373374|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.19||0.06|TWO_SIDED|95.0|-0.75|0.02|||ANCOVA|||||0.02|-0.75|0.06
73922498|NCT02472795|147373376|SUPERIORITY||Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.134||0.2837|TWO_SIDED|95.0|-0.413|0.123|||ANCOVA|||||0.123|-0.413|0.2837
73922499|NCT02472795|147373376|SUPERIORITY||Mean Difference (Final Values)|-0.515|STANDARD_ERROR_OF_MEAN|0.14||0.0006|TWO_SIDED|95.0|-0.797|-0.234|||ANCOVA|||||-0.234|-0.797|0.0006
73922500|NCT02472795|147373376|SUPERIORITY||Mean Difference (Final Values)|-0.565|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.825|-0.305|||ANCOVA|||||-0.305|-0.825|0.0001
73922501|NCT02472795|147373376|SUPERIORITY||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.147|<|0.0001|TWO_SIDED|95.0|-1.173|-0.586|||ANCOVA|||||-0.586|-1.173|<0.0001
73922502|NCT02472795|147373378|SUPERIORITY||Mean Difference (Final Values)|-13.214|STANDARD_ERROR_OF_MEAN|9.626||0.1755|TWO_SIDED|95.0|-32.513|6.085|||ANCOVA|||||6.085|-32.513|0.1755
73922503|NCT02472795|147373378|SUPERIORITY||Mean Difference (Final Values)|-39.311|STANDARD_ERROR_OF_MEAN|10.096||0.0003|TWO_SIDED|95.0|-59.552|-19.069|||ANCOVA|||||-19.069|-59.552|0.0003
73922504|NCT02472795|147373378|SUPERIORITY||Mean Difference (Final Values)|-47.278|STANDARD_ERROR_OF_MEAN|9.329|<|0.0001|TWO_SIDED|95.0|-65.981|-28.574|||ANCOVA|||||-28.574|-65.981|<0.0001
73922505|NCT02472795|147373378|SUPERIORITY||Mean Difference (Final Values)|-56.452|STANDARD_ERROR_OF_MEAN|10.541|<|0.0001|TWO_SIDED|95.0|-77.585|-35.32|||ANCOVA|||||-35.320|-77.585|<0.0001
73922506|NCT02432846|147373429|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.978||||0.964|TWO_SIDED|95.0|0.371|2.579|||Log Rank|||||2.579|0.371|0.964
73922507|NCT02432846|147373429|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.619||||0.163|TWO_SIDED|95.0|0.314|1.222|||Log Rank|||||1.222|0.314|0.163
73922508|NCT02432846|147373429|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.732||||0.25|TWO_SIDED|95.0|0.421|1.27|||Log Rank|||||1.270|0.421|0.250
73922509|NCT02432846|147373430|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.756||||0.596|TWO_SIDED|95.0|0.268|2.134|||Log Rank|||||2.134|0.268|0.596
73922510|NCT02432846|147373430|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.661||||0.285|TWO_SIDED|95.0|0.308|1.418|||Log Rank|||||1.418|0.308|0.285
73922511|NCT02432846|147373430|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.699||||0.24|TWO_SIDED|95.0|0.378|1.29|||Log Rank|||||1.290|0.378|0.240
73922512|NCT02432846|147373431|OTHER|Exploratory superiority (non-powered)|||||=|0.812|||||||Log Rank|||||||= 0.812
73922513|NCT02432846|147373432|OTHER|Exploratory superiority (non-powered)|||||=|0.861|||||||Log Rank|||||||= 0.861
73922514|NCT01770379|147373444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.2001|TWO_SIDED|95.0|0.79|3.03|||Regression, Logistic|||||3.03|0.79|0.2001
73922515|NCT01770379|147373444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1574|TWO_SIDED|95.0|0.83|3.15|||Regression, Logistic|||||3.15|0.83|0.1574
73922516|NCT03045887|147373468|OTHER||Ratio|0.41|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|90.0|0.27|0.61|||||AUC(0-t). Standard error of mean was on logged scale|||0.61|0.27|
74086857|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-44.48|STANDARD_ERROR_OF_MEAN|103.29|||TWO_SIDED|95.0|-247.11|158.15||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||158.15|-247.11|
74086858|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.69|STANDARD_ERROR_OF_MEAN|107.06|||TWO_SIDED|90.0|-238.31|182.93||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||182.93|-238.31|
73922517|NCT03045887|147373468|OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|90.0|0.65|1.47|||||AUC(0-t).Standard error of mean was on logged scale|||1.47|0.65|
73922518|NCT03045887|147373468|OTHER||Ratio|1.33|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|1.01|1.74|||||AUC(0-t).Standard error of mean was on logged scale|||1.74|1.01|
73922519|NCT03045887|147373468|OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|0.69|1.62|||||AUC(0-t).Standard error of mean was on logged scale|||1.62|0.69|
73922520|NCT03045887|147373468|OTHER||Ratio|1.25|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|0.95|1.64|||||AUC(0-t).Standard error of mean was on logged scale|||1.64|0.95|
73922521|NCT03045887|147373469|OTHER||Ratio|1.22|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|90.0|1.01|1.47|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for AUC(0-24) is presented|||1.47|1.01|
73922522|NCT03045887|147373470|OTHER||ratio|0.78|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.61|0.99||||||||0.99|0.61|
73922523|NCT03045887|147373470|OTHER||ratio|0.96|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.75|1.22||||||||1.22|0.75|
73922524|NCT03045887|147373470|OTHER||ratio|0.81|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|0.68|0.97||||||||0.97|0.68|
73922525|NCT03045887|147373470|OTHER||ratio|0.66|STANDARD_ERROR_OF_MEAN|0.154|||TWO_SIDED|90.0|0.51|0.86||||||||0.86|0.51|
73922526|NCT03045887|147373470|OTHER||ratio|0.76|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|0.63|0.9||||||||0.90|0.63|
73922527|NCT03045887|147373471|OTHER||ratio|1.14|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|0.96|1.36|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Cmax is presented|||1.36|0.96|
73922528|NCT03045887|147373477|OTHER||Ratio|2.06|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|90.0|1.67|2.55|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Ctau is presented.|||2.55|1.67|
73922529|NCT01912287|147373482|SUPERIORITY||Odds Ratio (OR)|2.46||||0.03|TWO_SIDED|95.0|1.12|5.42|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. SE at post-treatment||5.42|1.12|.03
73922530|NCT01912287|147373482|SUPERIORITY||Odds Ratio, log|5.0|||<|0.001|TWO_SIDED|95.0|2.12|11.82|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of CBT vs. SE at post-treatment||11.82|2.12|<.001
73922531|NCT01912287|147373482|SUPERIORITY||Odds Ratio (OR)|0.49||||0.07|TWO_SIDED|95.0|0.24|1.03|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. CBT at post-treatment||1.03|0.24|0.07
73922532|NCT03914326|147373487|SUPERIORITY|Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor.|Hazard Ratio (HR)|0.86||||0.0028|TWO_SIDED|95.0|0.77|0.96|||Regression, Cox|||||0.96|0.77|0.0028
73922533|NCT03226392|147373515|SUPERIORITY||Mean Difference (Net)|-0.031||||0.214|TWO_SIDED|95.0|-0.08|0.018|||ANCOVA|||||0.018|-0.080|0.214
73922534|NCT03226392|147373516|SUPERIORITY||Mean Difference (Net)|-0.1||||0.035|TWO_SIDED|0.035|-0.19|0.01|||ANCOVA|||||0.01|-0.19|0.035
73922535|NCT03226392|147373517|SUPERIORITY||Mean Difference (Net)|0.093||||0.893|TWO_SIDED|95.0|-0.2|0.17|||ANCOVA|||||0.17|-0.20|0.893
73922536|NCT03226392|147373518|SUPERIORITY||Mean Difference (Net)|0.061||||0.448|TWO_SIDED|95.0|-0.07|0.17|||ANCOVA|||||0.17|-0.07|0.448
73967703|NCT02437318|147472951|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.00065|TWO_SIDED|95.0|0.5|0.85||(one-sided)|Log Rank|||||0.85|0.50|0.00065
73967704|NCT04321031|147472994|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.02|0.2|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the statistical analysis plan (SAP).||0.20|-0.02|
73967705|NCT04321031|147472994|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|90.0|-0.03|0.24|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.24|-0.03|
73967706|NCT04321031|147472994|SUPERIORITY||Risk Difference (RD)|0.12|||||TWO_SIDED|90.0|-0.03|0.26|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.26|-0.03|
74028366|NCT01751646|147610388|OTHER|||||||0.1378|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.1378
74028367|NCT01751646|147610390|OTHER|||||||0.4686|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.4686
74028368|NCT01751646|147610392|OTHER|||||||0.7601|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.7601
74028369|NCT01751646|147610394|OTHER|||||||0.3978|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.3978
74028370|NCT01751646|147610396|OTHER|||||||0.1187|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.1187
74028371|NCT01751646|147610399|OTHER|||||||0.5098|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.5098
74028372|NCT01751646|147610400|OTHER|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.2550
74028373|NCT01751646|147610401|OTHER|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.6499
74028374|NCT01751646|147610402|OTHER|||||||0.2348|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.2348
74028375|NCT01751646|147610405|OTHER|||||||0.2648|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.2648
74028376|NCT01751646|147610408|OTHER|||||||0.3728|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.3728
74028377|NCT01751646|147610411|OTHER|||||||0.7825|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.7825
73922537|NCT04788953|147373519|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects tobit regression model (censored normal). Group (Solriamfetol, Placebo), visit (Baseline, End-of-Treatment), trial (1-4) main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||The statistical null hypothesis was that solriamfetol does not improve change in MWT scores versus placebo after 4 weeks of treatment (H0: µsol - µpl ≤ 0). Study was designed to have 97% power to detect a difference of 5.7 minutes or greater on MWT sleep latency (α=0.05, assumed σ=7.2) with 100 participants. Blinded interim power analysis on the baseline data conducted in October 2023 indicated the trial would have \>99% power to detect a similar difference with only 74 participants.||||<0.001
74028378|NCT01751646|147610414|OTHER|||||||0.195|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.1950
74028379|NCT01751646|147610417|OTHER|||||||0.7127|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.7127
74028380|NCT01751646|147610420|OTHER|||||||0.4676|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4676
74028381|NCT01751646|147610423|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0210
74028382|NCT01751646|147610426|OTHER|||||||0.0144|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0144
74028383|NCT01751646|147610429|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||< 0.0001
74028384|NCT01751646|147610432|OTHER|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0814
74028385|NCT01751646|147610435|OTHER|||||||0.4808|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4808
74028386|NCT01751646|147610438|OTHER|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.3870
74028387|NCT01751646|147610441|OTHER|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.4290
74028388|NCT01751646|147610442|OTHER|||||||0.9186|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.9186
74028389|NCT01751646|147610443|OTHER|||||||0.4016|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4016
74028390|NCT01751646|147610444|OTHER|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.5810
74028391|NCT01751646|147610445|OTHER|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.1570
74028392|NCT01751646|147610451|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to week 48||||<0.0001
73967707|NCT04321031|147472994|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|90.0|-0.04|0.28|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.28|-0.04|
73967708|NCT04321031|147472995|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.04|0.32||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.32|-0.04|
73967709|NCT04321031|147472995|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.11|0.27||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.27|-0.11|
73967710|NCT04321031|147472995|SUPERIORITY||Risk Difference (RD)|0.12|||||TWO_SIDED|90.0|-0.07|0.3||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.30|-0.07|
73967711|NCT04321031|147472995|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.07|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|0.07|
73967712|NCT04321031|147472995|SUPERIORITY||Risk Difference (RD)|0.07|||||TWO_SIDED|90.0|-0.12|0.27||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.27|-0.12|
73967713|NCT04321031|147472995|SUPERIORITY||Risk Difference (RD)|0.25|||||TWO_SIDED|90.0|0.04|0.42||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.42|0.04|
73967714|NCT04321031|147472995|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|50.0|0.08|0.23||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|0.08|
73967715|NCT04321031|147472995|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|90.0|-0.03|0.31||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.31|-0.03|
74028393|NCT01751646|147610451|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to Week 48||||<0.0001
73967716|NCT04321031|147472995|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|50.0|0.09|0.26||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.26|0.09|
73967717|NCT04321031|147472995|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|90.0|-0.03|0.35||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.35|-0.03|
73967718|NCT04321031|147472996|SUPERIORITY||Least Square (LS) Mean|-25.98|||||TWO_SIDED|90.0|-58.42|-2.57||||||||-2.57|-58.42|
73967719|NCT04321031|147472996|SUPERIORITY||LS Mean|-35.41|||||TWO_SIDED|90.0|-69.41|-5.42||||||||-5.42|-69.41|
73967720|NCT04321031|147472996|SUPERIORITY||LS Mean|-40.54|||||TWO_SIDED|90.0|-75.55|-7.32||||||||-7.32|-75.55|
73967721|NCT04321031|147472996|SUPERIORITY||LS Mean|-44.74|||||TWO_SIDED|90.0|-81.72|-8.42||||||||-8.42|-81.72|
73967722|NCT04321031|147472997|SUPERIORITY||LS Mean|-41.82|||||TWO_SIDED|90.0|-62.57|-9.57||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-9.57|-62.57|
73967723|NCT04321031|147472997|SUPERIORITY||LS Mean|-43.33|||||TWO_SIDED|90.0|-62.37|-14.64||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-14.64|-62.37|
73967724|NCT04321031|147472997|SUPERIORITY||LS Mean|-59.35|||||TWO_SIDED|90.0|-73.95|-36.55||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-36.55|-73.95|
73967725|NCT04321031|147472997|SUPERIORITY||LS Mean|-68.21|||||TWO_SIDED|90.0|-79.72|-50.15||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-50.15|-79.72|
73967726|NCT04321031|147472997|SUPERIORITY||LS Mean|-50.46|||||TWO_SIDED|90.0|-69.53|-19.44||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-19.44|-69.53|
74028394|NCT01751646|147610454|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline||||< 0.0001
74028395|NCT01751646|147610454|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline||||< 0.0001
74028396|NCT02973815|147610459|OTHER||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.065||0.342|TWO_SIDED|95.0|-0.194|0.067|||Regression, Linear|||This was adjusted for the baseline BMI-Z score, child sex, baseline child age, and economic assistance||0.067|-0.194|0.342
74028397|NCT02973815|147610460|OTHER||Mean Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.73104||0.09|TWO_SIDED|95.0|-0.2|2.71|||Regression, Linear|||Adjusted for: baseline HFI Fruit value, and economic assistance status||2.71|-0.20|0.09
73861663|NCT04557787|147269213|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.027|TWO_SIDED|95.0|0.06|0.88||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.88|0.06|0.027
73861664|NCT04557787|147269213|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.005|TWO_SIDED|95.0|0.19|1.02||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.02|0.19|0.005
73861665|NCT04557787|147269213|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.532|TWO_SIDED|95.0|-0.54|0.28||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.28|-0.54|0.532
73861666|NCT04557787|147269214|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.461|TWO_SIDED|95.0|-0.26|0.56||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.56|-0.26|0.461
73922538|NCT04788953|147373520|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol, Placebo), visit (Baseline, End-of-Treatment), trial (1-4) main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||<0.001
73922539|NCT04788953|147373521|SUPERIORITY|||||||0.01||||||"Chi-squared tests performed on dichotomized CGI-Change data (Improved \[very much improved, much improved, minimally improved\] vs. Not Improved \[no change, minimally worse, much worse, very much worse\])."|Chi-squared|P-value is difference between groups.||||||0.01
73922540|NCT04788953|147373523|SUPERIORITY|Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.||||||0.02|||||||Mixed Models Analysis|P-value is difference between groups.||||||0.02
73922541|NCT04788953|147373524|SUPERIORITY|||||||0.64||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.64
73922542|NCT04788953|147373525|SUPERIORITY|||||||0.04||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.04
73922543|NCT04788953|147373526|SUPERIORITY|||||||0.61||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and Condition (Baseline vs. Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.61
73861667|NCT04557787|147269214|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.12|TWO_SIDED|95.0|-0.09|0.73||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.73|-0.09|0.120
73922544|NCT04788953|147373527|SUPERIORITY|||||||0.57||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and Condition (Baseline vs. Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.57
73922545|NCT04788953|147373528|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||<0.001
73922546|NCT00469092|147373530|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is shown if the upper limit of the 95% CI is less than 0.4%. Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%. Equivalence is shown if the upper limit of the 95% CI for the difference is lower than 0.4% and the lower limit of the 95% CI is greater than -0.4%.|Mean Difference (Net)|-0.16||||0.029||95.0|-0.3|-0.02||P-value is for the test for difference in means equals 0 against the alternative that the difference is different from 0.|Regression, Linear|||HbA1c was compared between the treatment groups by fitting a linear regression model (ANCOVA) with treatment and country as factors and the baseline values as a continuous covariate. Mean and SE are estimated from the model.||-0.02|-0.30|0.029
73922547|NCT00469092|147373531|SUPERIORITY_OR_OTHER|||||||0.0059||95.0||||P-value for parallelism is overall test for parallel time profiles between treatment groups i.e. time by treatment group interaction effect.|Mixed Models Analysis|||The profiles were compared between the treatment groups by fitting a repeated measures mixed model including treatment, time, the treatment-by-time interaction and country as fixed effects, and subject as random effect.||||0.0059
73922548|NCT00469092|147373532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.914||||||95.0|0.57|1.47|||||The OR and 95% CI is for the HbA1c \<= 6.5% treatment target.|||1.47|0.57|
73922549|NCT00469092|147373532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||||95.0|0.67|1.54|||||The OR and 95% CI is for the HbA1c \< 7.0% treatment target.|||1.54|0.67|
73922550|NCT00469092|147373532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||||95.0|0.72|1.77|||||The OR and 95% CI is for the reduction more than 1.0% from baseline treatment target.|||1.77|0.72|
73922551|NCT00469092|147373532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.905||||||95.0|0.59|1.38|||||The OR and 95% CI is for the HbA1c \< 7% no nocturnal (00:00-06:00) hypoglycemia treatment target|||1.38|0.59|
73922552|NCT00469092|147373532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.181||||||95.0|0.74|1.87|||||The OR and 95% CI is for the HbA1c \< 7%, no daytime (06:01-23:59) hypoglycemia treatment target|||1.87|0.74|
73922553|NCT00469092|147373532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.122||||||95.0|0.69|1.82|||||The OR and 95% CI is for the HbA1c \< 7%, no hypoglycemia treatment target.|||1.82|0.69|
73922554|NCT00469092|147373533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||||95.0|-2.4|2.48|||||The mean difference and 95% CI is for the burden score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.48|-2.40|
73922555|NCT00469092|147373533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||||95.0|-3.56|3.11|||||The mean difference and 95% CI is for the efficacy score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||3.11|-3.56|
73967727|NCT04321031|147472997|SUPERIORITY||LS Mean|-69.27|||||TWO_SIDED|90.0|-81.08|-50.07||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-50.07|-81.08|
73967728|NCT04321031|147472997|SUPERIORITY||LS Mean|-21.8|||||TWO_SIDED|50.0|-34.02|-7.32||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-7.32|-34.02|
73967729|NCT04321031|147472997|SUPERIORITY||LS Mean|-21.8|||||TWO_SIDED|90.0|-48.51|18.76||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||18.76|-48.51|
74086859|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.46|STANDARD_ERROR_OF_MEAN|96.48|||TWO_SIDED|95.0|-221.17|158.24||||||Change from baseline at Month 48: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||158.24|-221.17|
74086860|NCT01115855|147727554|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.04|STANDARD_ERROR_OF_MEAN|28.85|||TWO_SIDED|95.0|-58.91|54.83||||||Change from baseline at Month 13 :ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||54.83|-58.91|
74086861|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.21|0.37||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.37|-0.21|
73922556|NCT00469092|147373533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||||95.0|-3.14|2.35|||||The mean difference and 95% CI is for the symptoms score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.35|-3.14|
73931048|NCT05569954|147391863|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|11.89|||<|0.001|TWO_SIDED|95.0|10.16|13.91||1-sided|cLDA model||V116/PPSV23|Serotype 31: V116/PPSV23 GMT Ratio||13.91|10.16|<0.001
73931049|NCT05569954|147391863|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|6.17|||<|0.001|TWO_SIDED|95.0|5.54|6.87||1-sided|cLDA model||V116/PPSV23|Serotype 35B: V116/PPSV23 GMT Ratio||6.87|5.54|<0.001
73931050|NCT05569954|147391864|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|26.0|||<|0.001|TWO_SIDED|95.0|20.9|31.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 6A: V116-PPSV23 Percentage Difference||31.0|20.9|<0.001
73931051|NCT05569954|147391864|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|39.4|||<|0.001|TWO_SIDED|95.0|33.6|44.8||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 15A: V116-PPSV23 Percentage Difference||44.8|33.6|<0.001
73931052|NCT05569954|147391864|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|11.7||||0.214|TWO_SIDED|95.0|7.5|15.9||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 15C: V116-PPSV23 Percentage Difference||15.9|7.5|0.214
73931053|NCT05569954|147391864|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|42.9|||<|0.001|TWO_SIDED|95.0|37.8|47.8||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 16F: V116-PPSV23 Percentage Difference||47.8|37.8|<0.001
73967730|NCT04321031|147472997|SUPERIORITY||LS Mean|-37.97|||||TWO_SIDED|50.0|-49.4|-23.95||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-23.95|-49.40|
73967731|NCT04321031|147472997|SUPERIORITY||LS Mean|-37.97|||||TWO_SIDED|90.0|-62.41|2.37||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||2.37|-62.41|
74086862|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.34|0.3||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.30|-0.34|
74086863|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.27|0.39||||||Change from baseline at Month 13: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.39|-0.27|
74086864|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.41|0.45||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.45|-0.41|
74086865|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.56|0.24||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.24|-0.56|
74086866|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.55|0.25||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.25|-0.55|
74086867|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.49|0.31||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.31|-0.49|
74086868|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.57|0.44||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.44|-0.57|
74086869|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.5|0.54||||||Change from baseline at Month 37 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.54|-0.50|
74086870|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.44|0.83||||||Change from baseline at Month 42 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.83|-0.44|
74086871|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.63|0.89||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.89|-0.63|
74086872|NCT01115855|147727556|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.11||||||Change from baseline at Week 4 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.11|-0.36|
74086873|NCT02960438|147727562|SUPERIORITY||Difference of arms|2.2||||0.374|TWO_SIDED|95.0|-19.96|24.46|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||24.46|-19.96|0.374
73861668|NCT04557787|147269214|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.404|TWO_SIDED|95.0|-0.58|0.24||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.24|-0.58|0.404
73861669|NCT04557787|147269215|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.478|TWO_SIDED|95.0|-0.33|0.71||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.71|-0.33|0.478
73861670|NCT04557787|147269215|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.824|TWO_SIDED|95.0|-0.46|0.58||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.58|-0.46|0.824
73861671|NCT04557787|147269215|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.626|TWO_SIDED|95.0|-0.39|0.65||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.65|-0.39|0.626
73861672|NCT04557787|147269216|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.03|TWO_SIDED|95.0|0.09|1.64||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.64|0.09|0.030
73861673|NCT04557787|147269216|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.027|TWO_SIDED|95.0|0.11|1.66||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.66|0.11|0.027
73861674|NCT04557787|147269216|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.956|TWO_SIDED|95.0|-0.8|0.75||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.75|-0.80|0.956
73861675|NCT04557787|147269217|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.084|TWO_SIDED|95.0|-0.05|0.78||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.78|-0.05|0.084
73861676|NCT04557787|147269217|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.063|TWO_SIDED|95.0|-0.02|0.81||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.81|-0.02|0.063
73861677|NCT04557787|147269217|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.885|TWO_SIDED|95.0|-0.44|0.38||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.38|-0.44|0.885
73861678|NCT01969500|147269222|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|3.81||0.85|TWO_SIDED|95.0|-8.37|6.96|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks|||6.96|-8.37|.85
73861679|NCT01969500|147269223|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.67||0.44|TWO_SIDED|95.0|-4.66|2.06|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks|||2.06|-4.66|.44
73861680|NCT00613080|147269235|SUPERIORITY_OR_OTHER||Proportion (reported as percentage)|51.0||||0.93|TWO_SIDED||||||Chi-squared|||This study was designed for a one-sided chi-square test to detect at least 12% reduction in the 40% rate of ≥ grade 2 treatment-related preoperative GI AEs from the conventional radiotherapy / capecitabine /oxaliplatin arm of study RTOG-0247 (NCT00081289) with 80% power and a one-sided type I error rate of 0.10.||||0.93
73861681|NCT02726880|147269273|SUPERIORITY||F|1.13||||0.296|TWO_SIDED||||||ANCOVA|Number of days of gaming in the past week, measured at baseline, is included as a covariate in the model.||||||.296
73861682|NCT04384107|147269288|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-1.1|||=|0.641|TWO_SIDED|95.0|-5.9|3.6|||Miettinen & Nurminen|||Injection site erythema||3.6|-5.9|= 0.641
73861683|NCT04384107|147269288|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.2|||=|0.937|TWO_SIDED|95.0|-6.1|5.6|||Miettinen & Nurminen|||Injection site induration||5.6|-6.1|= 0.937
73861684|NCT04384107|147269288|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|7.1|||=|0.036|TWO_SIDED|95.0|0.5|13.8|||Miettinen & Nurminen|||Injection site pain||13.8|0.5|= 0.036
73861685|NCT04384107|147269288|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-4.0|||=|0.208|TWO_SIDED|95.0|-10.2|2.2|||Miettinen & Nurminen|||Injection site swelling||2.2|-10.2|= 0.208
73922557|NCT00469092|147373533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||||95.0|-2.36|2.14|||Regression, Linear||The mean difference and 95% CI is for the overall score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|Diab MedSat measure was scored as an overall score as well as three subscale scores, and transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.14|-2.36|
73922558|NCT02024867|147373536|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 120 per group was calculated according to an assumed treatment cure rate of 95% with 10 days of antibiotics, and a non-inferiority margin of 7% (allowing up to 88% cure rate with 3 days of antibiotics), to achieve a power of 0.80 (alpha=0.05). An additional 25 patients were recruited to account for an estimated 10% lost to follow-up.|Rate Difference|4.0||||0.25|TWO_SIDED|95.0|-1.5|9.5|||Chi-squared|||||9.5|-1.5|0.25
73922559|NCT02024867|147373537|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.7||||0.02|TWO_SIDED|95.0|2.1|19.2|||Chi-squared|||||19.2|2.1|0.02
73922560|NCT02024867|147373538|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.1||||0.03|TWO_SIDED|95.0|2.1|18.2|||Chi-squared|||||18.2|2.1|0.03
74028398|NCT02973815|147610461|OTHER||Mean Difference (Net)|1.23|STANDARD_ERROR_OF_MEAN|0.61||0.047|TWO_SIDED|95.0|0.02|2.44|||Regression, Linear|||Adjusted for: baseline HFI Vegetable value, and economic assistance status||2.44|0.02|0.047
73861686|NCT04384107|147269289|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.4|||=|0.912|TWO_SIDED|95.0|-6.7|6.0|||Miettinen & Nurminen|||Decreased appetite||6.0|-6.7|= 0.912
74086874|NCT02960438|147727562|SUPERIORITY||Difference of arms|11.1||||0.102|TWO_SIDED|95.0|-7.42|29.64|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||29.64|-7.42|0.102
74086875|NCT02960438|147727562|SUPERIORITY||Difference of arms|9.3||||0.188|TWO_SIDED|95.0|-9.25|27.77|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||27.77|-9.25|0.188
74086876|NCT02322788|147727589|SUPERIORITY_OR_OTHER||Estimated mean ratio|1.87|||<|0.001|TWO_SIDED|95.0|1.52|2.29|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||2.29|1.52|<0.001
73922561|NCT02024867|147373539|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|0.1|||>|0.05|TWO_SIDED|95.0|-6.9|7.0|||Chi-squared|||||7.0|-6.9|>0.05
73922562|NCT02024867|147373540|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.3||||0.046|TWO_SIDED|95.0|0.8|19.9|||Chi-squared|||||19.9|0.8|0.046
73922563|NCT02024867|147373541|NON_INFERIORITY_OR_EQUIVALENCE|described previously|rate difference|0.0|||>|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||>0.05
73922564|NCT00706979|147373597|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.008|TWO_SIDED|95.0|1.1|1.4|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate of any ever-occurring quit attempt.||1.4|1.1|0.008
73922565|NCT00706979|147373598|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.09|TWO_SIDED|95.0|1.0|1.7|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate of 7 days of abstinence at some point during the study.||1.7|1.0|0.09
73922566|NCT00706979|147373599|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.004|TWO_SIDED|95.0|1.1|1.5|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate for the primary outcome of any 24hr quit attempt.||1.5|1.1|0.004
73922567|NCT00706979|147373600|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.3|TWO_SIDED|95.0|0.9|1.6|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate for 7 days of abstinence at the six month follow-up.||1.6|0.9|0.3
73922568|NCT03992781|147373601|SUPERIORITY||Relative change|-53.1|||<|0.001|||||||t-test|||Relative change in CUDOS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
73922569|NCT03992781|147373602|SUPERIORITY||Relative change|-35.4|||<|0.001|||||||t-test|||Relative change in CUDOS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
73922570|NCT03992781|147373603|SUPERIORITY||Relative change|-33.2|||<|0.001|||||||t-test|||Relative change in CUXOS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
73922571|NCT03992781|147373603|SUPERIORITY||Relative change|-47.1|||<|0.001|||||||t-test|||Relative change in CUXOS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
73967732|NCT04321031|147472998|SUPERIORITY||Risk Difference (RD)|0.21|||||TWO_SIDED|90.0|0.09|0.32|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.32|0.09|
73967733|NCT04321031|147472998|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.15|0.37|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.37|0.15|
73922572|NCT03992781|147373604|SUPERIORITY||Relative change|-27.6|||<|0.001|||||||t-test|||Relative change in JSEQ score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
73922573|NCT03992781|147373604|SUPERIORITY||Relative change|-34.5|||<|0.001|||||||t-test|||Relative change in JSEQ score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
73922574|NCT03992781|147373605|SUPERIORITY||Relative change|-43.4|||<|0.001|||||||t-test|||Relative change in VAS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
73922575|NCT03992781|147373605|SUPERIORITY||Relative change|-35.4|||<|0.001|||||||t-test|||Relative change in VAS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
73922576|NCT03164928|147373613|SUPERIORITY||Least Squares Mean Difference|0.11||||0.68|TWO_SIDED|95.0|-0.45|0.673|||ANCOVA|||||0.673|-0.450|0.68
73922577|NCT03164928|147373614|SUPERIORITY||Least Squares Mean Difference|0.17||||0.34|TWO_SIDED|95.0|-0.194|0.542|||Repeated Measures Model|||Month 6||0.542|-0.194|0.34
73922578|NCT03164928|147373614|SUPERIORITY||Least Squares Mean Difference|0.03||||0.93|TWO_SIDED|95.0|-0.609|0.661|||Repeated Measures Model|||Month 18||0.661|-0.609|0.93
73922579|NCT03164928|147373614|SUPERIORITY||Least Squares Mean Difference|0.11||||0.74|TWO_SIDED|95.0|-0.572|0.795|||Repeated Measures Model|||Month 24||0.795|-0.572|0.74
73922580|NCT03164928|147373614|SUPERIORITY||Least Squares Means Difference|-0.8||||0.12|TWO_SIDED|95.0|-1.848|0.239|||Repeated Measures Model|||Month 36||0.239|-1.848|0.12
73922581|NCT03164928|147373615|SUPERIORITY||Least Squares Mean Difference|-0.41||||0.19|TWO_SIDED|95.0|-1.05|0.223|||Repeated Measures Model|||Month 6 (Total Hip)||0.223|-1.050|0.19
73922582|NCT03164928|147373615|SUPERIORITY||Least Squares Mean Difference|-0.06||||0.83|TWO_SIDED|95.0|-0.631|0.515|||Repeated Measures Model|||Month 12 (Total Hip)||0.515|-0.631|0.83
73922583|NCT03164928|147373615|SUPERIORITY||Least Squares Mean Difference|-0.27||||0.51|TWO_SIDED|95.0|-1.108|0.565|||Repeated Measures Model|||Month 18 (Total Hip)||0.565|-1.108|0.51
73922584|NCT03164928|147373615|SUPERIORITY||Least Squares Mean Difference|-0.18||||0.69|TWO_SIDED|95.0|-1.098|0.746|||Repeated Measures Model|||Month 24 (Total Hip)||0.746|-1.098|0.69
73922585|NCT03164928|147373615|SUPERIORITY||Least Squares Mean Difference|-0.09||||0.89|TWO_SIDED|95.0|-1.465|1.286|||Repeated Measures Model|||Month 36 (Total Hip)||1.286|-1.465|0.89
73922586|NCT03164928|147373615|SUPERIORITY||Least Squares Mean Difference|-0.18||||0.64|TWO_SIDED|95.0|-0.969|0.614|||Repeated Measures Model|||Month 6 (Femoral Neck)||0.614|-0.969|0.64
73922587|NCT03164928|147373615|SUPERIORITY||Least Squares Mean Difference|0.1||||0.83|TWO_SIDED|95.0|-0.808|1.0|||Repeated Measures Model|||Month 12 (Femoral Neck)||1.000|-0.808|0.83
73922588|NCT03164928|147373615|SUPERIORITY||Least Squares Mean Difference|0.37||||0.48|TWO_SIDED|95.0|-0.697|1.442|||Repeated Measures Model|||Month 18 (Femoral Neck)||1.442|-0.697|0.48
73922589|NCT03164928|147373615|SUPERIORITY||Least Squares Mean Difference|0.11||||0.86|TWO_SIDED|95.0|-1.222|1.443|||Repeated Measures Model|||Month 24 (Femoral Neck)||1.443|-1.222|0.86
73922590|NCT03164928|147373615|SUPERIORITY||Least Squares Mean Difference|0.38||||0.66|TWO_SIDED|95.0|-1.378|2.13|||Repeated Measures Model|||Month 36 (Femoral Neck)||2.130|-1.378|0.66
73922591|NCT02278263|147373627|SUPERIORITY||||||<|0.05|||||||ANOVA|||Assuming a common standard deviation of 412 mL, to detect a difference of 300 mL of blood loss between the two treatment arms (sTXA and tTXA) and the placebo group, a sample size of 125 participants is required for a statistical power of 0.85, and a type I error of 0.05. The sample size required was 125 participants in total. The was increased by 15% to allow for expected dropouts. Therefore, a minimum of 147 patients was required for the study.||||<0.05
73922592|NCT03997383|147373637|SUPERIORITY||Median Difference (Net)|14.693||||0.0162|TWO_SIDED|95.0|0.693|28.692||P-value was determined by the Wilcoxon Rank Sum test,stratified by baseline tafamidis use.Analysis was performed on the 100 multiply-imputed datasets.|Wilcoxon Rank Sum Test||Median difference estimated by the Hodges-Lehmann method, stratified by baseline tafamidis use. Analysis was performed on the 100 multiply-imputed datasets.|||28.692|0.693|0.0162
73922593|NCT03997383|147373638|SUPERIORITY||Least squares (LS) mean difference|3.709|STANDARD_ERROR_OF_MEAN|1.796||0.0397|TWO_SIDED|95.0|0.176|7.242||P-value was analyzed using mixed model repeated measures (MMRM) as described in the Statistical analysis plan.|MMRM|||||7.242|0.176|0.0397
73922594|NCT03997383|147373639|SUPERIORITY||Stratified Win Ratio|1.27||||0.0574|TWO_SIDED|95.0|0.99|1.61|||Z-test|P-value was analyzed by a z-test using the mean and variance of the log-transformed win ratio estimate.||||1.61|0.99|0.0574
73967734|NCT04321031|147472998|SUPERIORITY||Risk Difference (RD)|0.29|||||TWO_SIDED|90.0|0.18|0.39|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.39|0.18|
73967735|NCT04321031|147472998|SUPERIORITY||Risk Difference (RD)|0.31|||||TWO_SIDED|90.0|0.19|0.42|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.42|0.19|
73922595|NCT03997383|147373640|SUPERIORITY||Hazard Ratio (HR)|0.997||||0.9888|TWO_SIDED|95.0|0.62|1.602|||Andersen-Gill||HR was derived using an Andersen-Gill model, including the treatment arm, type of ATTR amyloidosis, baseline New York Heart Association (NYHA) class, and age as covariates.|||1.602|0.620|0.9888
73922596|NCT03997383|147373641|SUPERIORITY||Hazard Ratio (HR)|0.883||||0.5609|TWO_SIDED|95.0|0.582|1.341|||Modified Andersen-Gill|P-value was derived using the modified Andersen-Gill model stratified by baseline tafamidis use.|HR was derived using the modified Andersen-Gill model stratified by baseline tafamidis use, including treatment arm, type of ATTR amyloidosis, baseline NYHA class, and age as covariates.|||1.341|0.582|0.5609
73922597|NCT03033511|147373653|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.537|TWO_SIDED|95.0|0.84|1.36||stratified log-rank test|Log Rank|||||1.36|0.84|0.537
73922598|NCT03033511|147373654|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.237|TWO_SIDED|95.0|0.92|1.36||stratified log-rank test|Log Rank|||||1.36|0.92|0.237
73922599|NCT03033511|147373655|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.36|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|-3.08|2.35||||||Change at Week 6||2.35|-3.08|
73922600|NCT03033511|147373655|SUPERIORITY||LS Mean of Difference|-10.43|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-14.58|-6.29||||||Change at Week 12||-6.29|-14.58|
73922601|NCT03033511|147373655|SUPERIORITY||LS Mean of Difference|-27.67|STANDARD_ERROR_OF_MEAN|10.57|||TWO_SIDED|95.0|-46.19|-9.16||||||Change at Week 18||-9.16|-46.19|
73922602|NCT03033511|147373655|SUPERIORITY||LS Mean of Difference|-18.44|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-38.28|1.39||||||Change at Week 24||1.39|-38.28|
73922603|NCT03033511|147373655|SUPERIORITY||LS Mean of Difference|-22.0|STANDARD_ERROR_OF_MEAN|11.27|||TWO_SIDED|95.0|-42.63|-1.37||||||Change at Week 30||-1.37|-42.63|
73967736|NCT04321031|147472999|SUPERIORITY||Risk Difference (RD)|0.23|||||TWO_SIDED|90.0|0.04|0.51||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.51|0.04|
73922604|NCT03033511|147373655|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 36||||
73922605|NCT03033511|147373655|SUPERIORITY||LS Mean of Difference|3.33|||||TWO_SIDED|||||||||Change at Week 42||||
73922606|NCT03033511|147373655|SUPERIORITY||LS Mean of Difference|-56.67|||||TWO_SIDED|||||||||Change at Week 48||||
73922607|NCT03033511|147373655|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 60||||
73922608|NCT03033511|147373655|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 66||||
73922609|NCT03033511|147373655|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 78||||
73922610|NCT03033511|147373655|SUPERIORITY||LS Mean of Difference|-9.17|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|95.0|-12.16|-6.19||||||Change at Final Visit||-6.19|-12.16|
73922611|NCT00455429|147373676|SUPERIORITY_OR_OTHER|||||||0.6|||||||Cochran-Mantel-Haenszel|||||||0.600
73922612|NCT00455429|147373676|SUPERIORITY_OR_OTHER|||||||0.822|||||||Cochran-Mantel-Haenszel|||||||0.822
73922613|NCT00455429|147373676|SUPERIORITY_OR_OTHER|||||||0.656|||||||Cochran-Mantel-Haenszel|||||||0.656
73922614|NCT00455429|147373677|SUPERIORITY_OR_OTHER||LS Mean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.63||0.427|TWO_SIDED|95.0|-9.7|2.9|||Dunnett-Hsu|||||2.90|-9.70|0.427
73922615|NCT00455429|147373677|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.55||0.922|TWO_SIDED|95.0|-7.37|4.82|||Dunnett-Hsu|||||4.82|-7.37|0.922
73922616|NCT00455429|147373677|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.24||0.919|TWO_SIDED|95.0|-6.49|4.21|||Dunnett-Hsu|||||4.21|-6.49|0.919
73922617|NCT00455429|147373678|SUPERIORITY_OR_OTHER||LS Mean difference|3.7|STANDARD_ERROR_OF_MEAN|8.15||0.941|TWO_SIDED|95.0|-15.83|23.18|||Dunnett-Hsu|||||23.18|-15.83|0.941
73922618|NCT00455429|147373678|SUPERIORITY_OR_OTHER||LS Mean Difference|14.2|STANDARD_ERROR_OF_MEAN|8.07||0.196|TWO_SIDED|95.0|-5.12|33.52|||Dunnett-Hsu|||||33.52|-5.12|0.196
73922619|NCT00455429|147373678|SUPERIORITY_OR_OTHER||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|7.08||0.096|TWO_SIDED|95.0|-2.0|31.86|||Dunnett-Hsu|||||31.86|-2.00|0.096
73922620|NCT00455429|147373679|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Logistic|||||||0.460
73922621|NCT00455429|147373679|SUPERIORITY_OR_OTHER|||||||0.479|||||||Regression, Logistic|||||||0.479
73922622|NCT00455429|147373679|SUPERIORITY_OR_OTHER|||||||0.462|||||||Regression, Logistic|||||||0.462
73922623|NCT00455429|147373680|SUPERIORITY_OR_OTHER|||||||0.363|||||||Regression, Logistic|||||||0.363
73922624|NCT00455429|147373680|SUPERIORITY_OR_OTHER|||||||0.968|||||||Regression, Logistic|||||||0.968
73922625|NCT00455429|147373680|SUPERIORITY_OR_OTHER|||||||0.501|||||||Regression, Logistic|||||||0.501
73922626|NCT00455429|147373681|SUPERIORITY_OR_OTHER|||||||0.333|||||||Regression, Logistic|||||||0.333
73922627|NCT00455429|147373681|SUPERIORITY_OR_OTHER|||||||0.527|||||||Regression, Logistic|||||||0.527
73922628|NCT00455429|147373681|SUPERIORITY_OR_OTHER|||||||0.353|||||||Regression, Logistic|||||||0.353
73922629|NCT00455429|147373682|SUPERIORITY_OR_OTHER|||||||0.631|||||||Regression, Logistic|||||||0.631
73922630|NCT00455429|147373682|SUPERIORITY_OR_OTHER|||||||0.523|||||||Regression, Logistic|||||||0.523
73922631|NCT00455429|147373682|SUPERIORITY_OR_OTHER|||||||0.101|||||||Regression, Logistic|||||||0.101
73922632|NCT00455429|147373683|SUPERIORITY_OR_OTHER|||||||0.429|||||||Regression, Logistic|||||||0.429
73922633|NCT00455429|147373683|SUPERIORITY_OR_OTHER|||||||0.206|||||||Regression, Logistic|||||||0.206
73922634|NCT00455429|147373683|SUPERIORITY_OR_OTHER|||||||0.107|||||||Regression, Logistic|||||||0.107
73922635|NCT00455429|147373684|SUPERIORITY_OR_OTHER|||||||0.097|||||||Regression, Logistic|||||||0.097
73922636|NCT00455429|147373684|SUPERIORITY_OR_OTHER|||||||0.077|||||||Regression, Logistic|||||||0.077
73922637|NCT00455429|147373684|SUPERIORITY_OR_OTHER|||||||0.489|||||||Regression, Logistic|||||||0.489
73922638|NCT00455429|147373685|SUPERIORITY_OR_OTHER|||||||0.566|||||||Regression, Logistic|||||||0.566
73922639|NCT00455429|147373685|SUPERIORITY_OR_OTHER|||||||0.382|||||||Regression, Logistic|||||||0.382
73922640|NCT00455429|147373685|SUPERIORITY_OR_OTHER|||||||0.282|||||||Regression, Logistic|||||||0.282
73922641|NCT00455429|147373686|SUPERIORITY_OR_OTHER|||||||0.206|||||||Regression, Logistic|||||||0.206
73922642|NCT00455429|147373686|SUPERIORITY_OR_OTHER|||||||0.433|||||||Regression, Logistic|||||||0.433
73922643|NCT00455429|147373686|SUPERIORITY_OR_OTHER|||||||0.29|||||||Regression, Logistic|||||||0.290
73922644|NCT00455429|147373687|SUPERIORITY_OR_OTHER|||||||0.484|||||||Regression, Logistic|||||||0.484
73922645|NCT00455429|147373687|SUPERIORITY_OR_OTHER|||||||0.952|||||||Regression, Logistic|||||||0.952
73922646|NCT00455429|147373687|SUPERIORITY_OR_OTHER|||||||0.35|||||||Regression, Logistic|||||||0.350
73922647|NCT04351087|147373713|EQUIVALENCE|Power analysis based on (MCID) for the KOOS-Pain, alpha 0.05 \& SD 15 points, 88 patients (44/group) would be required to detect a 9-point difference between treatment groups with 80% power. Due to change in regulatory requirements during accrual, enrollment was halted at 79 patients with 71 meeting inclusion criteria. A repeated power calculation demonstrated that the study achieved 56% power to detect a between-group difference in excess of the 9-point MCID for the KOOS-Pain.|Mean Difference (Final Values)|2.17||||0.69|TWO_SIDED|95.0|-8.57|12.92|||t-test, 2 sided|||||12.92|-8.57|0.69
73922648|NCT05517382|147373771|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||At baseline||||0.20
73922649|NCT05517382|147373771|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||At Post game||||0.59
73922650|NCT05517382|147373771|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||At 3 month||||0.94
73922651|NCT05517382|147373771|SUPERIORITY|||||||0.55|||||||GEE|Controlling for baseline thriving status, this reflects the interaction between the intervention group and time.||||||0.55
73922652|NCT05517382|147373772|SUPERIORITY||Mean Difference (Net)|-0.09||||0.1759|TWO_SIDED|95.0|-0.23|0.04|||Mixed Models Analysis||Group effect.|At post game.||0.04|-0.23|0.1759
73922653|NCT05517382|147373772|SUPERIORITY||Mean Difference (Net)|-0.16||||0.0857|TWO_SIDED|95.0|-0.35|0.02|||Mixed Models Analysis||Group effect.|At 3 month||0.02|-0.35|0.0857
73922654|NCT01641692|147373782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066||||0.036|TWO_SIDED|95.0|0.004|0.127|||Mixed Models Analysis|||||0.127|0.004|0.036
73922655|NCT01641692|147373782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.331|TWO_SIDED|95.0|-0.03|0.09|||Mixed Models Analysis|||||0.090|-0.030|0.331
73922656|NCT01641692|147373782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.272|TWO_SIDED|95.0|-0.027|0.095|||Mixed Models Analysis|||||0.095|-0.027|0.272
73922657|NCT01641692|147373782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.005|TWO_SIDED|95.0|0.026|0.149|||Mixed Models Analysis|||||0.149|0.026|0.005
73922658|NCT01641692|147373782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.722|TWO_SIDED|95.0|-0.05|0.073|||Mixed Models Analysis|||||0.073|-0.050|0.722
73922659|NCT01641692|147373782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057||||0.076|TWO_SIDED|95.0|-0.006|0.119|||Mixed Models Analysis|||||0.119|-0.006|0.076
73922660|NCT01641692|147373782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051||||0.101|TWO_SIDED|95.0|-0.01|0.113|||Mixed Models Analysis|||||0.113|-0.010|0.101
73922661|NCT01641692|147373785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.1|1.7|||Mixed Models Analysis|||||1.7|-2.1|0.840
73861687|NCT04384107|147269289|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|5.9|||=|0.108|TWO_SIDED|95.0|-1.3|13.0|||Miettinen & Nurminen|||Irritability||13.0|-1.3|= 0.108
73967737|NCT04321031|147472999|SUPERIORITY||Risk Difference (RD)|0.37|||||TWO_SIDED|90.0|0.13|0.63||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.63|0.13|
73861688|NCT04384107|147269289|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.0|||=|0.792|TWO_SIDED|95.0|-6.4|8.4|||Miettinen & Nurminen|||Somnolence||8.4|-6.4|= 0.792
73861689|NCT04384107|147269289|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.3|||=|0.843|TWO_SIDED|95.0|-3.5|2.8|||Miettinen & Nurminen|||Urticaria||2.8|-3.5|= 0.843
73861690|NCT04384107|147269290|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.4|1.3||||||||1.3|-1.4|
73861691|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 1: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
73922662|NCT01641692|147373785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.553|TWO_SIDED|95.0|-2.4|1.3|||Mixed Models Analysis|||||1.3|-2.4|0.553
73922663|NCT01641692|147373785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.121|TWO_SIDED|95.0|-0.4|3.3|||Mixed Models Analysis|||||3.3|-0.4|0.121
73922664|NCT01641692|147373785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.814|TWO_SIDED|95.0|-2.1|1.7|||Mixed Models Analysis|||||1.7|-2.1|0.814
73922665|NCT01641692|147373785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.683|TWO_SIDED|95.0|-1.5|2.3|||Mixed Models Analysis|||||2.3|-1.5|0.683
73967738|NCT04321031|147472999|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|90.0|0.04|0.49||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.49|0.04|
73861692|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|2.3|||<|0.001|TWO_SIDED|95.0|1.0|4.5|||Miettinen and Nurminen|||Serotype 3: Participants With IgG ≥0.35 μg/mL||4.5|1.0|< 0.001
73861693|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.1|||Miettinen and Nurminen|||Serotype 4: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|< 0.001
73861694|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.2|||<|0.001|TWO_SIDED|95.0|-3.0|-0.1|||Miettinen and Nurminen|||Serotype 5: Participants With IgG ≥0.35 μg/mL||-0.1|-3.0|< 0.001
73861695|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.9|||<|0.001|TWO_SIDED|95.0|-2.6|0.2|||Miettinen and Nurminen|||Serotype 6A: Participants With IgG ≥0.35 μg/mL||0.2|-2.6|< 0.001
73922666|NCT01641692|147373785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.456|TWO_SIDED|95.0|-1.2|2.7|||Mixed Models Analysis|||||2.7|-1.2|0.456
73922667|NCT01641692|147373785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.399|TWO_SIDED|95.0|-2.7|1.1|||Mixed Models Analysis|||||1.1|-2.7|0.399
73922668|NCT01641692|147373786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.03|TWO_SIDED|95.0|0.2|3.2|||Mixed Models Analysis|||||3.2|0.2|0.030
73922669|NCT01641692|147373786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.077|TWO_SIDED|95.0|-0.1|2.8|||Mixed Models Analysis|||||2.8|-0.1|0.077
73967739|NCT04321031|147472999|SUPERIORITY||Risk Difference (RD)|0.54|||||TWO_SIDED|90.0|0.26|0.75||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.75|0.26|
73922670|NCT01641692|147373786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.01|TWO_SIDED|95.0|0.5|3.5|||Mixed Models Analysis|||||3.5|0.5|0.010
73922671|NCT01641692|147373786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.002|TWO_SIDED|95.0|0.9|3.9|||Mixed Models Analysis|||||3.9|0.9|0.002
73922672|NCT01641692|147373786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.005|TWO_SIDED|95.0|0.7|3.7|||Mixed Models Analysis|||||3.7|0.7|0.005
73922673|NCT01641692|147373786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.001|TWO_SIDED|95.0|1.2|4.3|||Mixed Models Analysis|||||4.3|1.2|<0.001
73922674|NCT01641692|147373786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.054|TWO_SIDED|95.0|0.0|3.0|||Mixed Models Analysis|||||3.0|0.0|0.054
73922675|NCT01641692|147373787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.752|TWO_SIDED|95.0|-1.4|2.0|||Mixed Models Analysis|||||2.0|-1.4|0.752
73922676|NCT01641692|147373787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.072|TWO_SIDED|95.0|-0.1|3.2|||Mixed Models Analysis|||||3.2|-0.1|0.072
73922677|NCT01641692|147373787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.503|TWO_SIDED|95.0|-1.1|2.2|||Mixed Models Analysis|||||2.2|-1.1|0.503
73922678|NCT01641692|147373787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.476|TWO_SIDED|95.0|-1.1|2.3|||Mixed Models Analysis|||||2.3|-1.1|0.476
73922679|NCT01641692|147373787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.084|TWO_SIDED|95.0|-0.2|3.2|||Mixed Models Analysis|||||3.2|-0.2|0.084
73922680|NCT01641692|147373787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.97|TWO_SIDED|95.0|-1.8|1.7|||Mixed Models Analysis|||||1.7|-1.8|0.970
73922681|NCT01641692|147373787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.423|TWO_SIDED|95.0|-2.4|1.0|||Mixed Models Analysis|||||1.0|-2.4|0.423
73922682|NCT00657241|147373829|SUPERIORITY|All hemodynamic variables are continuous and all participants received both treatments, so paired-t analysis could be used. While paired t-tests do not necessarily require a power and sample size analysis, we estimated that 30 subjects were sufficient to detect an 8% difference in CTTI between comparators at p\<0.05 with a conservatively estimated power of 0.8.|||||<|0.05|||||||t-test, 2 sided|||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||<0.05
73922683|NCT00657241|147373831|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
73922684|NCT00657241|147373832|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|Paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
73922685|NCT00657241|147373833|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
73922686|NCT00657241|147373834|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
73967740|NCT04321031|147472999|SUPERIORITY||Risk Difference (RD)|0.34|||||TWO_SIDED|90.0|0.1|0.61||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.61|0.10|
73967741|NCT04321031|147472999|SUPERIORITY||Risk Difference (RD)|0.48|||||TWO_SIDED|90.0|0.2|0.72||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.72|0.20|
73922687|NCT05027438|147373918|SUPERIORITY||Mean Difference (Net)|-7.58|STANDARD_DEVIATION|5.19|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 1.42 (large \>=0.35)|||<0.001
73922688|NCT05027438|147373918|SUPERIORITY||Mean Difference (Net)|-7.06|STANDARD_DEVIATION|4.4|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 1.54 (large \>=0.35)|||<0.001
73922689|NCT05027438|147373919|SUPERIORITY||Mean Difference (Net)|58.55|STANDARD_DEVIATION|43.98||0.004|TWO_SIDED|||||Bonferroni correction|Friedman test|||% change in medication dose from baseline to post-treatment||||0.004
73922690|NCT05027438|147373919|SUPERIORITY||Mean Difference (Net)|62.26|STANDARD_DEVIATION|54.93||0.005|TWO_SIDED|||||Bonferroni correction|Friedman test|||% change in medication dose from baseline to 3-month follow-up||||0.005
73922691|NCT05027438|147373920|SUPERIORITY||Proportion (%)|31.8||||0.052|TWO_SIDED||||||Cochran's Q test|Bonferroni correction||baseline to post-treatment||||0.052
73922692|NCT05027438|147373920|SUPERIORITY||Proportion (%)|60.0|||<|0.001|TWO_SIDED||||||Cochran's Q test|Bonferroni correction||baseline to 3-month follow-up||||<0.001
73922693|NCT05027438|147373921|SUPERIORITY||Mean Difference (Net)|-16.67|STANDARD_DEVIATION|20.57|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 0.54 (large \>=0.35)|||<0.001
73922694|NCT05027438|147373921|SUPERIORITY||Mean Difference (Net)|-17.11|STANDARD_DEVIATION|22.11|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 0.47 (large \>=0.35)|||<0.001
73922695|NCT05027438|147373922|SUPERIORITY||Mean Difference (Net)|-6.24|STANDARD_DEVIATION|20.34||0.101|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 0.10 (small \>=0.02)|||0.101
73967742|NCT04321031|147472999|SUPERIORITY||Risk Difference (RD)|0.32|||||TWO_SIDED|50.0|0.24|0.39||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.39|0.24|
73922696|NCT05027438|147373922|SUPERIORITY||Mean Difference (Net)|-10.34|STANDARD_DEVIATION|18.28|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 0.34 (medium; large \>=0.35)|||<0.001
73922697|NCT05027438|147373923|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_DEVIATION|6.0|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (positive value indicates improvement)|baseline to post-treatment|effect size (f2) = 0.87 (large \>=0.35)|||<0.001
73922698|NCT05027438|147373923|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_DEVIATION|6.0|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (positive value indicates improvement)|baseline to 3-month follow-up|effect size (f2) = 0.96 (large \>=0.35)|||<0.001
73967743|NCT04321031|147472999|SUPERIORITY||Risk Difference (RD)|0.32|||||TWO_SIDED|90.0|0.12|0.48||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.48|0.12|
73967744|NCT04321031|147472999|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|50.0|0.06|0.23||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|0.06|
73967745|NCT04321031|147472999|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.06|0.33||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.33|-0.06|
73967746|NCT04321031|147473000|SUPERIORITY||Risk Difference (RD)|-0.05|||||TWO_SIDED|90.0|-0.16|0.02|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.02|-0.16|
73967747|NCT04321031|147473000|SUPERIORITY||Risk Difference (RD)|-0.07|||||TWO_SIDED|90.0|-0.2|0.03|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.03|-0.20|
73967748|NCT04321031|147473000|SUPERIORITY||Risk Difference (RD)|-0.09|||||TWO_SIDED|90.0|-0.23|0.04|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.04|-0.23|
73967749|NCT04321031|147473000|SUPERIORITY||Risk Difference (RD)|-0.1|||||TWO_SIDED|90.0|-0.26|0.05|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.05|-0.26|
73967750|NCT04321031|147473001|SUPERIORITY||Risk Difference (RD)|-0.07|||||TWO_SIDED|90.0|-0.21|0.13||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.13|-0.21|
73967751|NCT04321031|147473001|SUPERIORITY||Risk Difference (RD)|-0.14|||||TWO_SIDED|90.0|-0.25|0.02||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.02|-0.25|
74086877|NCT02322788|147727589|SUPERIORITY_OR_OTHER||Estimated mean ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.46|2.2|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||2.20|1.46|<0.001
73967752|NCT04321031|147473001|SUPERIORITY||Risk Difference (RD)|-0.02|||||TWO_SIDED|90.0|-0.17|0.17||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.17|-0.17|
74086878|NCT02322788|147727589|NON_INFERIORITY_OR_EQUIVALENCE|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.92|||||TWO_SIDED|95.0|0.75|1.13|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||1.13|0.75|
73967753|NCT04321031|147473001|SUPERIORITY||Risk Difference (RD)|0.02|||||TWO_SIDED|90.0|-0.15|0.22||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.22|-0.15|
73967754|NCT04321031|147473001|SUPERIORITY||Risk Difference (RD)|-0.22|||||TWO_SIDED|90.0|-0.3|-0.05||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||-0.05|-0.30|
73967755|NCT04321031|147473001|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.13|0.26||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.26|-0.13|
73967756|NCT04321031|147473001|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|50.0|-0.03|0.12||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.12|-0.03|
73967757|NCT04321031|147473001|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.12|0.23||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|-0.12|
73967758|NCT04321031|147473001|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|50.0|0.17|0.38||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.38|0.17|
73967759|NCT04321031|147473001|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.06|0.53||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.53|0.06|
73967760|NCT04321031|147473002|SUPERIORITY||Risk Difference (RD)|0.03|||||TWO_SIDED|90.0|-0.01|0.08|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.08|-0.01|
73967761|NCT04321031|147473002|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.02|0.09|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.09|-0.02|
73922699|NCT05027438|147373924|SUPERIORITY||Mean Difference (Net)|-7.48|STANDARD_DEVIATION|6.08|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates improvement)|Sleep Disturbance - higher scores indicate more sleep disturbance. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.|effect size (f2) = 1.14 (large \>=0.35)|||<0.001
73922700|NCT05027438|147373924|SUPERIORITY||Mean Difference (Net)|-7.82|STANDARD_DEVIATION|5.62|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates improvement)|Sleep Disturbance - higher scores indicate more sleep disturbance. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.|effect size (f2) = 1.21 (large \>=0.35)|||<0.001
73922701|NCT05027438|147373925|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_DEVIATION|0.21||0.22|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (positive value indicates improvement)||effect size (f2) = 0.18 (medium \>=0.15)|||0.22
73922702|NCT05027438|147373925|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.12|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (positive value indicates improvement)||effect size (f2) = 1.99 (large \>=0.35)|||<0.001
73922703|NCT00861146|147373950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Chi-squared|df = 1||||||<.01
73967762|NCT04321031|147473002|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.02|0.11|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.11|-0.02|
73967763|NCT04321031|147473002|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.02|0.12|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.12|-0.02|
73967764|NCT04321031|147473003|SUPERIORITY||Risk Difference (RD)|0.09|||||TWO_SIDED|90.0|-0.01|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|-0.01|
73967765|NCT04321031|147473003|SUPERIORITY||Risk Difference (RD)|0.03|||||TWO_SIDED|90.0|-0.02|0.29||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.29|-0.02|
73967766|NCT04321031|147473003|SUPERIORITY||Risk Difference (RD)|0.09|||||TWO_SIDED|90.0|-0.01|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|-0.01|
73967767|NCT04321031|147473003|SUPERIORITY||Risk Difference (RD)|0.17|||||TWO_SIDED|90.0|0.01|0.57||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.57|0.01|
73967768|NCT04321031|147473003|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.02|0.33||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.33|-0.02|
73967769|NCT04321031|147473003|SUPERIORITY||Risk Difference (RD)|0.17|||||TWO_SIDED|90.0|0.01|0.58||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.58|0.01|
73967770|NCT04321031|147473003|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|50.0|0.02|0.16||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.16|0.02|
73922704|NCT00861146|147373951|SUPERIORITY_OR_OTHER_LEGACY||mixed model regression analyses (F)|2.04|||>|0.15|||||||mixed model regression analyses|||Drinking outcomes assessed using the timeline follow-back were evaluated with mixed model regression analyses using maximum likelihood estimation. Time was measured in three monthly periods and treated as a repeated factor (due to the fixed time period between estimates).||||> .15
73922705|NCT00861146|147373952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|df=1||||||<.001
73967771|NCT04321031|147473003|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.04|0.3||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.30|-0.04|
73922706|NCT02981342|147373953|SUPERIORITY|||||||0.0495|||||||Cochran-Mantel-Haenszel|||||||0.0495
74028399|NCT02973815|147610462|OTHER||Mean Difference (Net)|0.48|STANDARD_ERROR_OF_MEAN|0.2||0.019|TWO_SIDED|95.0|0.08|0.88|||Regression, Linear|||Adjusted for: baseline healthfulness score and economic assistance status||0.88|0.08|0.019
74028400|NCT02973815|147610463|OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.12||0.218|TWO_SIDED|95.0|-0.4|0.09|||Regression, Linear|||Adjusted for: baseline vegetable intake, child age (baseline), parent education status (bachelors or higher vs lower)||0.09|-0.4|0.218
74028401|NCT02973815|147610464|OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.2||0.066|TWO_SIDED|95.0|-0.03|0.77|||Regression, Linear|||Adjusted for: baseline fruit intake, child age (baseline), parent education status (bachelors or higher vs lower)||0.77|-0.03|0.066
74028402|NCT02973815|147610465|OTHER||Mean Difference (Net)|-4.79|STANDARD_ERROR_OF_MEAN|4.41||0.28|TWO_SIDED|95.0|-13.56|3.98|||Regression, Linear|||Adjusted for: baseline MVPA, child age (baseline), and child sex||3.98|-13.56|0.28
73922707|NCT02981342|147373953|SUPERIORITY|||||||0.023|||||||Cochran-Mantel-Haenszel|||||||0.0230
73922708|NCT02981342|147373954|SUPERIORITY|||||||0.0085|||||||Log Rank|||||||0.0085
73922709|NCT02981342|147373954|SUPERIORITY|||||||0.0123|||||||Log Rank|||||||0.0123
73922710|NCT02981342|147373955|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1
73922711|NCT02981342|147373955|SUPERIORITY|||||||0.3017|||||||Cochran-Mantel-Haenszel|||||||0.3017
73922712|NCT02981342|147373960|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1
73922713|NCT02981342|147373960|SUPERIORITY|||||||0.3017|||||||Cochran-Mantel-Haenszel|||||||0.3017
73922714|NCT02981342|147373962|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.1938|TWO_SIDED|95.0|0.782|3.272|||Log Rank|||||3.272|0.782|0.1938
73967772|NCT04321031|147473003|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|50.0|0.06|0.24||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.24|0.06|
73967773|NCT04321031|147473003|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|90.0|-0.01|0.44||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.44|-0.01|
73967774|NCT04321031|147473004|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|90.0|0.05|0.31|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.31|0.05|
73967775|NCT04321031|147473004|SUPERIORITY||Risk Difference (RD)|0.23|||||TWO_SIDED|90.0|0.09|0.36|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.36|0.09|
73967776|NCT04321031|147473004|SUPERIORITY||Risk Difference (RD)|0.25|||||TWO_SIDED|90.0|0.1|0.38|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.38|0.10|
73967777|NCT04321031|147473004|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.11|0.4|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.40|0.11|
73967778|NCT04321031|147473005|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.04|0.36||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.36|-0.04|
73922715|NCT02981342|147373962|SUPERIORITY||Hazard Ratio (HR)|1.533||||0.2477|TWO_SIDED|95.0|0.746|3.15|||Log Rank|||||3.150|0.746|0.2477
73967779|NCT04321031|147473005|SUPERIORITY||Risk Difference (RD)|0.35|||||TWO_SIDED|90.0|0.15|0.53||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.53|0.15|
73922716|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.74||0.383|TWO_SIDED|95.0|-0.84|2.13|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours||2.13|-0.84|0.383
73922717|NCT02981342|147373964|SUPERIORITY||LSMean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.79||0.692|TWO_SIDED|95.0|-1.91|1.28|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours||1.28|-1.91|0.692
73922718|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.66||0.469|TWO_SIDED|95.0|-0.85|1.8|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours||1.80|-0.85|0.469
73922719|NCT02981342|147373964|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.776|TWO_SIDED|95.0|-1.62|1.22|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours||1.22|-1.62|0.776
73922720|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.7||0.328|TWO_SIDED|95.0|-0.72|2.11|||Mixed Models Analysis|||Pain on the Average||2.11|-0.72|0.328
73922721|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.74||0.954|TWO_SIDED|95.0|-1.45|1.54|||Mixed Models Analysis|||Pain on the Average||1.54|-1.45|0.954
73922722|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.8||0.35|TWO_SIDED|95.0|-0.85|2.36|||Mixed Models Analysis|||Pain Right Now||2.36|-0.85|0.350
73922723|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.85||0.405|TWO_SIDED|95.0|-1.01|2.44|||Mixed Models Analysis|||Pain right now.||2.44|-1.01|0.405
73922724|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.73||0.565|TWO_SIDED|95.0|-1.06|1.91|||Mixed Models Analysis|||Pain Interfered General Activity||1.91|-1.06|0.565
73922725|NCT02981342|147373964|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.79||0.848|TWO_SIDED|95.0|-1.74|1.43|||Mixed Models Analysis|||Pain Interfered General Activity||1.43|-1.74|0.848
73922726|NCT02981342|147373964|SUPERIORITY||LSMean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.65||0.928|TWO_SIDED|95.0|-1.37|1.25|||Mixed Models Analysis|||Pain Interfered with Mood||1.25|-1.37|0.928
73922727|NCT02981342|147373964|SUPERIORITY||LSMean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.69||0.65|TWO_SIDED|95.0|-1.71|1.08|||Mixed Models Analysis|||Pain Interfered with Mood||1.08|-1.71|0.650
73922728|NCT02981342|147373964|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.86||0.865|TWO_SIDED|95.0|-1.89|1.6|||Mixed Models Analysis|||Pain Interfered Walking Ability||1.60|-1.89|0.865
73922729|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.92||0.497|TWO_SIDED|95.0|-1.23|2.5|||Mixed Models Analysis|||Pain Interfered Walking Ability||2.50|-1.23|0.497
73922730|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.89|STANDARD_ERROR_OF_MEAN|0.8||0.272|TWO_SIDED|95.0|-0.72|2.5|||Mixed Models Analysis|||Pain Interfered with Normal Work||2.50|-0.72|0.272
73922731|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.47|STANDARD_ERROR_OF_MEAN|0.85||0.583|TWO_SIDED|95.0|-1.25|2.19|||Mixed Models Analysis|||Pain Interfered with Normal Work||2.19|-1.25|0.583
73922732|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.82||0.876|TWO_SIDED|95.0|-1.53|1.79|||Mixed Models Analysis|||Pain Interfered with Relations||1.79|-1.53|0.876
73922733|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.88||0.644|TWO_SIDED|95.0|-1.37|2.19|||Mixed Models Analysis|||Pain Interfered with relations.||2.19|-1.37|0.644
73922734|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.85||0.384|TWO_SIDED|95.0|-0.97|2.48|||Mixed Models Analysis|||Pain Interfered with Sleep||2.48|-0.97|0.384
73922735|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.89||0.318|TWO_SIDED|95.0|-0.9|2.71|||Mixed Models Analysis|||||2.71|-0.90|0.318
73922736|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.97||0.407|TWO_SIDED|95.0|-1.15|2.78|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life||2.78|-1.15|0.407
73922737|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.52|STANDARD_ERROR_OF_MEAN|1.04||0.62|TWO_SIDED|95.0|-1.58|2.62|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life||2.62|-1.58|0.620
73922738|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.475|TWO_SIDED|95.0|-0.9|1.91|||Mixed Models Analysis|||BPI-Mean Interference Score||1.91|-0.90|0.475
73922739|NCT02981342|147373964|SUPERIORITY||LSMean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.74||0.54|TWO_SIDED|95.0|-1.04|1.96|||Mixed Models Analysis|||BPI-Mean Interference Score||1.96|-1.04|0.540
73922740|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-1.39|STANDARD_ERROR_OF_MEAN|5.98||0.818|TWO_SIDED|95.0|-13.46|10.68|||Mixed Models Analysis|||Global health status||10.68|-13.46|0.818
73922741|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-3.8|STANDARD_ERROR_OF_MEAN|6.06||0.533|TWO_SIDED|95.0|-16.03|8.42|||Mixed Models Analysis|||Global health status||8.42|-16.03|0.533
73922742|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-2.79|STANDARD_ERROR_OF_MEAN|6.75||0.681|TWO_SIDED|95.0|-16.4|10.82|||Mixed Models Analysis|||Functional Scales: Physical functioning||10.82|-16.40|0.681
73967780|NCT04321031|147473005|SUPERIORITY||Risk Difference (RD)|0.26|||||TWO_SIDED|90.0|0.06|0.46||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.46|0.06|
74086879|NCT02322788|147727589|NON_INFERIORITY_OR_EQUIVALENCE|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||1.08|0.72|
73922743|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-9.02|STANDARD_ERROR_OF_MEAN|6.75||0.189|TWO_SIDED|95.0|-22.63|4.59|||Mixed Models Analysis|||Functional Scales: Physical functioning||4.59|-22.63|0.189
73922744|NCT02981342|147373965|SUPERIORITY||LSMean Difference|0.96|STANDARD_ERROR_OF_MEAN|9.54||0.921|TWO_SIDED|95.0|-18.29|20.21|||Mixed Models Analysis|||Functional Scales: Role functioning||20.21|-18.29|0.921
73922745|NCT02981342|147373965|SUPERIORITY||LSMean Difference|0.01|STANDARD_ERROR_OF_MEAN|9.62||0.999|TWO_SIDED|95.0|-19.4|19.42|||Mixed Models Analysis|||Functional Scales: Role functioning.||19.42|-19.40|0.999
73922746|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-4.26|STANDARD_ERROR_OF_MEAN|6.91||0.541|TWO_SIDED|95.0|-18.2|9.68|||Mixed Models Analysis|||Functional Scales: Emotional functioning||9.68|-18.20|0.541
73922747|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-6.95|STANDARD_ERROR_OF_MEAN|7.05||0.33|TWO_SIDED|95.0|-21.17|7.27|||Mixed Models Analysis|||Functional Scales: Emotional functioning||7.27|-21.17|0.330
73922748|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-2.04|STANDARD_ERROR_OF_MEAN|6.29||0.747|TWO_SIDED|95.0|-14.74|10.66|||Mixed Models Analysis|||Functional Scales: Cognitive Functioning||10.66|-14.74|0.747
73922749|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-5.25|STANDARD_ERROR_OF_MEAN|6.43||0.419|TWO_SIDED|95.0|-18.22|7.73|||Mixed Models Analysis|||Functional Scales: Cognitive functioning||7.73|-18.22|0.419
73922750|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-4.02|STANDARD_ERROR_OF_MEAN|7.53||0.596|TWO_SIDED|95.0|-19.23|11.19|||Mixed Models Analysis|||Functional Scales: Social functioning||11.19|-19.23|0.596
73922751|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-19.12|STANDARD_ERROR_OF_MEAN|7.71||0.017|TWO_SIDED|95.0|-34.68|-3.55|||Mixed Models Analysis|||Functional Scales: Social functioning||-3.55|-34.68|0.017
73922752|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-0.77|STANDARD_ERROR_OF_MEAN|7.57||0.919|TWO_SIDED|95.0|-16.03|14.49||Social Scales: Fatigue|Mixed Models Analysis|||Symptoms Scales: Fatigue||14.49|-16.03|0.919
73922753|NCT02981342|147373965|SUPERIORITY||LSMean Difference|8.48|STANDARD_ERROR_OF_MEAN|7.54||0.267|TWO_SIDED|95.0|-6.72|23.69|||Mixed Models Analysis|||Symptom Scales: Fatigue||23.69|-6.72|0.267
73922754|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-1.45|STANDARD_ERROR_OF_MEAN|8.54||0.866|TWO_SIDED|95.0|-18.66|15.77|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting||15.77|-18.66|0.866
73922755|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-3.9|STANDARD_ERROR_OF_MEAN|8.59||0.652|TWO_SIDED|95.0|-21.23|13.43|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting||13.43|-21.23|0.652
73922756|NCT02981342|147373965|SUPERIORITY||LSMean Difference|7.11|STANDARD_ERROR_OF_MEAN|8.67||0.417|TWO_SIDED|95.0|-10.39|24.6|||Mixed Models Analysis|||Symptom Scales: Pain||24.60|-10.39|0.417
73922757|NCT02981342|147373965|SUPERIORITY||LSMean Difference|4.36|STANDARD_ERROR_OF_MEAN|8.69||0.618|TWO_SIDED|95.0|-13.16|21.89|||Mixed Models Analysis|||Symptom Scales: Pain||21.89|-13.16|0.618
73922758|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-10.84|STANDARD_ERROR_OF_MEAN|8.44||0.206|TWO_SIDED|95.0|-27.85|6.18|||Mixed Models Analysis|||Symptom Scales: Dyspnoea||6.18|-27.85|0.206
73922759|NCT02981342|147373965|SUPERIORITY||LSMean Difference|4.86|STANDARD_ERROR_OF_MEAN|8.4||0.566|TWO_SIDED|95.0|-12.08|21.8|||Mixed Models Analysis|||Symptom Scales: Dyspnoea||21.80|-12.08|0.566
73922760|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-7.02|STANDARD_ERROR_OF_MEAN|7.93||0.38|TWO_SIDED|95.0|-23.01|8.96|||Mixed Models Analysis|||Symptom Scales: Insomnia||8.96|-23.01|0.380
73922761|NCT02981342|147373965|SUPERIORITY||LSMean Difference|1.52|STANDARD_ERROR_OF_MEAN|7.99||0.85|TWO_SIDED|95.0|-14.6|17.64|||Mixed Models Analysis|||Symptom Scales: Insomnia||17.64|-14.60|0.850
73861696|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-3.9|||<|0.001|TWO_SIDED|95.0|-6.9|-1.3|||Miettinen and Nurminen|||Serotype 6B: Participants With IgG ≥0.35 μg/mL||-1.3|-6.9|< 0.001
73861697|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 7F: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
73922762|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-2.79|STANDARD_ERROR_OF_MEAN|8.91||0.756|TWO_SIDED|95.0|-20.78|15.21|||Mixed Models Analysis|||Symptom Scales: Appetite loss||15.21|-20.78|0.756
73922763|NCT02981342|147373965|SUPERIORITY||LSMean Difference|3.02|STANDARD_ERROR_OF_MEAN|9.31||0.747|TWO_SIDED|95.0|-15.77|21.82|||Mixed Models Analysis|||Symptom Scales: Appetite loss||21.82|-15.77|0.747
73922764|NCT02981342|147373965|SUPERIORITY||LSMean Difference|9.47|STANDARD_ERROR_OF_MEAN|9.23||0.311|TWO_SIDED|95.0|-9.16|28.09|||Mixed Models Analysis|||Symptom Scales: Constipation||28.09|-9.16|0.311
73922765|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-9.97|STANDARD_ERROR_OF_MEAN|9.3||0.29|TWO_SIDED|95.0|-28.75|8.8|||Mixed Models Analysis|||Symptom Scales: Constipation||8.80|-28.75|0.290
74086880|NCT04039919|147727600|OTHER||Geometric LS Mean ratio|0.785|||||TWO_SIDED|90.0|0.6513|0.9461||||||The log-transformed PK parameters was analyzed by a mixed analysis of variance (ANOVA) with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.||0.9461|0.6513|
74086881|NCT04039919|147727601|OTHER||Geometric LS Mean Ratio|0.8342|||||TWO_SIDED|90.0|0.6999|0.9942||||||The log-transformed PK parameters was analyzed by a mixed ANOVA with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.||0.9942|0.6999|
74086882|NCT05918822|147727625|OTHER|A mixed-effects model was applied to log (ln)-transformed plasma maribavir Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as random effect. Point estimates and their associated 90% confidence intervals (CIs) were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimate and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|82.19|||||TWO_SIDED|90.0|74.31|90.91|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||90.91|74.31|
73922766|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-10.57|STANDARD_ERROR_OF_MEAN|10.58||0.323|TWO_SIDED|95.0|-31.93|10.78|||Mixed Models Analysis|||Symptom Scales: Diarrhoea||10.78|-31.93|0.323
73922767|NCT02981342|147373965|SUPERIORITY||LSMean Difference|-4.8|STANDARD_ERROR_OF_MEAN|10.54||0.651|TWO_SIDED|95.0|-26.08|16.48|||Mixed Models Analysis|||Symptom Scales: Diarrhoea||16.48|-26.08|0.651
73922768|NCT02981342|147373965|SUPERIORITY||LSMean Difference|1.51|STANDARD_ERROR_OF_MEAN|7.47||0.841|TWO_SIDED|95.0|-13.57|16.59|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties||16.59|-13.57|0.841
73922769|NCT02981342|147373965|SUPERIORITY||LSMean Difference|7.26|STANDARD_ERROR_OF_MEAN|7.57||0.344|TWO_SIDED|95.0|-8.03|22.54|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties||22.54|-8.03|0.344
73922770|NCT02389998|147373974|SUPERIORITY||||||<|0.03|||||||ANCOVA|||||||<0.03
73922771|NCT02389998|147373975|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||.001
73922772|NCT02389998|147373976|SUPERIORITY|||||||0.3|||||||McNemar|||||||0.3
73922773|NCT03814746|147373996|SUPERIORITY||Rate ratio|1.08|||>|0.999|TWO_SIDED|95.0|0.76|1.55|||negative binomial regression model|||||1.55|0.76|> 0.999
73922774|NCT03814746|147373996|SUPERIORITY||Rate ratio|0.89|||>|0.999|TWO_SIDED|95.0|0.62|1.27|||negative binomial regression model|||||1.27|0.62|> 0.999
73922775|NCT03814746|147373997|SUPERIORITY||Rate ratio|1.21|||||TWO_SIDED|95.0|0.87|1.7|||negative binomial regression model|||||1.70|0.87|
73922776|NCT03814746|147373997|SUPERIORITY||Rate ratio|0.83|||||TWO_SIDED|95.0|0.59|1.17|||negative binomial regression model|||||1.17|0.59|
73922777|NCT03814746|147374002|SUPERIORITY||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.92|1.97|||Cox Model|for time to first occurrence of VOC||||1.97|0.92|
73922778|NCT03814746|147374002|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.72|1.58|||Cox Model|for time to first occurrence of VOC||||1.58|0.72|
73922779|NCT03814746|147374002|SUPERIORITY|for time to second occurrence of VOC|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.81|2.04|||Cox Model|||||2.04|0.81|
73922780|NCT03814746|147374002|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.59|1.54|||Cox Model|for time to second occurrence of VOC||||1.54|0.59|
73922781|NCT03814746|147374003|SUPERIORITY||Rate ratio|1.03|||||TWO_SIDED|95.0|0.75|1.43|||Negative binomial regression model|for the Annualized rate of all visits to clinics, emergency rooms and hospitalizations||||1.43|0.75|
73922782|NCT03814746|147374003|SUPERIORITY||Rate ratio|0.82|||||TWO_SIDED|95.0|0.59|1.14|||Negative binomial regression model|for the Annualized rate of all visits to clinics, emergency rooms and hospitalizations||||1.14|0.59|
73922783|NCT03814746|147374003|SUPERIORITY||Rate ratio|1.11|||||TWO_SIDED|95.0|0.77|1.59|||Negative binomial regression model|for the Annualized rate of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.59|0.77|
73922784|NCT03814746|147374003|SUPERIORITY||Rate ratio|0.87|||||TWO_SIDED|95.0|0.6|1.25|||Negative binomial regression model|for the Annualized rate of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.25|0.60|
73922785|NCT03814746|147374004|SUPERIORITY||Rate ratio|1.34|||||TWO_SIDED|95.0|0.85|2.09|||Negative binomial regression model|for the Annualized days of all visits to clinics, emergency rooms and hospitalizations||||2.09|0.85|
73967781|NCT04321031|147473005|SUPERIORITY||Risk Difference (RD)|0.48|||||TWO_SIDED|90.0|0.27|0.63||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.63|0.27|
73967782|NCT04321031|147473005|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|90.0|-0.03|0.38||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.38|-0.03|
73967783|NCT04321031|147473005|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|90.0|0.18|0.58||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.58|0.18|
73967784|NCT04321031|147473005|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|50.0|0.15|0.28||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.28|0.15|
73967785|NCT04321031|147473005|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|90.0|0.03|0.35||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.35|0.03|
73967786|NCT04321031|147473005|SUPERIORITY||Risk Difference (RD)|0.24|||||TWO_SIDED|50.0|0.16|0.32||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.32|0.16|
73967787|NCT04321031|147473005|SUPERIORITY||Risk Difference (RD)|0.24|||||TWO_SIDED|90.0|0.03|0.42||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.42|0.03|
73967788|NCT03143153|147473011|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.001|TWO_SIDED|98.6|0.46|0.9||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model.|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.||0.90|0.46|0.0010
73967789|NCT03143153|147473011|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.001|TWO_SIDED|95.0|0.49|0.84||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.||0.84|0.49|0.0010
73967790|NCT03143153|147473011|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|99.5|0.37|0.8||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.80|0.37|<0.0001
73967791|NCT03143153|147473011|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.71||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.71|0.41|<0.0001
74086883|NCT05918822|147727625|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90 percent (%) CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|57.72|||||TWO_SIDED|90.0|52.18|63.84|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||63.84|52.18|
73967792|NCT03143153|147473012|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8958|TWO_SIDED|98.5|0.73|1.43||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.43|0.73|0.8958
73967793|NCT03143153|147473012|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8958|TWO_SIDED|95.0|0.78|1.34||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.34|0.78|0.8958
73967794|NCT03143153|147473012|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0023|TWO_SIDED|98.5|0.46|0.92||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.92|0.46|0.0023
73967795|NCT03143153|147473012|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0023|TWO_SIDED|95.0|0.49|0.86||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.86|0.49|0.0023
73967796|NCT03143153|147473013|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.011||95.0|0.65|0.95||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||0.95|0.65|0.0110
73967797|NCT03143153|147473013|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.011||98.2|0.62|0.98||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||0.98|0.62|0.0110
73967798|NCT03143153|147473013|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0021||99.1|0.58|0.96||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.96|0.58|0.0021
74028403|NCT02973815|147610466|OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.928|TWO_SIDED|95.0|-0.31|0.34|||Regression, Linear|||Adjusted for: baseline screentime, child age (baseline), and child sex||0.34|-0.31|0.928
74028404|NCT02613572|147610467|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
74028405|NCT02613572|147610468|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||||||0.009
74028406|NCT02613572|147610469|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
74028407|NCT02613572|147610470|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.30
74028408|NCT02613572|147610471|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||||||0.14
73861698|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 9V: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
73861699|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.9|1.1|||Miettinen and Nurminen|||Serotype 14: Participants With IgG ≥0.35 μg/mL||1.1|-1.9|< 0.001
73922786|NCT03814746|147374004|SUPERIORITY||Rate ratio|0.88|||||TWO_SIDED|95.0|0.57|1.38|||Negative binomial regression model|for the Annualized days of all visits to clinics, emergency rooms and hospitalizations||||1.38|0.57|
73922787|NCT03814746|147374004|SUPERIORITY||Rate ratio|1.27|||||TWO_SIDED|95.0|0.77|2.09|||Negative binomial regression model|for the Annualized days of VOC-related visits to clinics, emergency rooms and hospitalizations||||2.09|0.77|
74086884|NCT05918822|147727625|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir Cmax with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|49.03|||||TWO_SIDED|90.0|40.07|60.0|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||60.00|40.07|
73922788|NCT03814746|147374004|SUPERIORITY||Rate ratio|0.87|||||TWO_SIDED|95.0|0.52|1.44|||Negative binomial regression model|for the Annualized days of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.44|0.52|
74028409|NCT02613572|147610472|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|||||||0.69
74028410|NCT02342561|147610488|SUPERIORITY_OR_OTHER|||||||0.601|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||At end of surgery||||0.601
74028411|NCT02342561|147610488|SUPERIORITY_OR_OTHER|||||||0.823|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||After skin disinfection||||0.823
74028412|NCT02342561|147610489|SUPERIORITY_OR_OTHER|||||||0.731|TWO_SIDED||||||Fisher Exact|||Difference in prevalence of CoNs between the 2 groups was analysed. The null-hypothesis was no difference.||||0.731
74028413|NCT01748695|147610496|SUPERIORITY_OR_OTHER|||||||0.834||||||Based on a linear mixed measures model with treatment and period included as fixed effects, subject included as a random effect and between- and within- subject baseline covariates included.|Regression, Linear|||||||0.834
74028414|NCT01333189|147610502|SUPERIORITY_OR_OTHER||||||=|0.329|TWO_SIDED||||||Mixed Models Analysis|||||||=0.329
74028415|NCT01333189|147610503|SUPERIORITY_OR_OTHER||||||=|0.891|TWO_SIDED||||||Mixed Models Analysis|||||||=0.891
74028416|NCT01333189|147610504|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||Mixed Models Analysis|||||||=0.021
74028417|NCT01333189|147610505|SUPERIORITY_OR_OTHER||||||=|0.509|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.509
74028418|NCT01333189|147610505|SUPERIORITY_OR_OTHER||||||=|0.5|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.500
74028419|NCT01333189|147610505|SUPERIORITY_OR_OTHER||||||=|0.607|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.607
74028420|NCT01333189|147610506|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||Mixed Models Analysis|||||||=0.068
74028421|NCT01333189|147610507|SUPERIORITY_OR_OTHER||||||=|0.48|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.480
74028422|NCT01333189|147610507|SUPERIORITY_OR_OTHER||||||=|0.12|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.120
74028423|NCT01333189|147610507|SUPERIORITY_OR_OTHER||||||=|0.668|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.668
74028424|NCT01333189|147610508|SUPERIORITY_OR_OTHER||||||=|0.511|TWO_SIDED||||||Mixed Models Analysis|||||||=0.511
74028425|NCT01333189|147610509|SUPERIORITY_OR_OTHER||||||=|0.402|TWO_SIDED||||||Mixed Models Analysis|||||||=0.402
74028426|NCT01333189|147610510|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||Mixed Models Analysis|||||||=0.021
74028427|NCT01333189|147610511|SUPERIORITY_OR_OTHER||||||=|0.686|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.686
74028428|NCT01333189|147610511|SUPERIORITY_OR_OTHER||||||=|0.434|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.434
74028429|NCT01333189|147610511|SUPERIORITY_OR_OTHER||||||=|0.227|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.227
74028430|NCT01333189|147610512|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||Mixed Models Analysis|||||||=0.068
74028431|NCT01333189|147610513|SUPERIORITY_OR_OTHER||||||=|0.16|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.160
74028432|NCT01333189|147610513|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.008
74028433|NCT01333189|147610513|SUPERIORITY_OR_OTHER||||||=|0.877|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.877
73967799|NCT03143153|147473013|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0021|TWO_SIDED|95.0|0.61|0.9||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.90|0.61|0.0021
73967800|NCT03143153|147473014|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|1.04|1.52|||||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.52|1.04|
73967801|NCT03143153|147473014|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0355|TWO_SIDED|95.0|0.67|0.99||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.99|0.67|0.0355
73967802|NCT03143153|147473014|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0355|TWO_SIDED|98.5|0.64|1.04||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||1.04|0.64|0.0355
73967803|NCT02312557|147473016|OTHER||Proportion|0.19|||<|0.01|TWO_SIDED|95.0|0.09|0.29|||One-sample binomial test of proportion|||||0.29|0.09|<0.01
73967804|NCT02736409|147473036|SUPERIORITY||Difference in Proportion|-0.19||||0.131|TWO_SIDED|95.0|-0.452|0.082|||Fisher Exact|||||0.082|-0.452|0.131
73967805|NCT05722704|147473112|SUPERIORITY||Median Difference (Net)|0.118|STANDARD_DEVIATION|0.05||0.986|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.986
73967806|NCT05722704|147473113|SUPERIORITY||Median Difference (Net)|0.016|STANDARD_DEVIATION|0.05|<|0.118|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.118
74086885|NCT05918822|147727626|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|97.59|||||TWO_SIDED|90.0|91.39|104.2|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||104.20|91.39|
73967807|NCT05722704|147473114|SUPERIORITY||Median Difference (Net)|95.0|STANDARD_DEVIATION|0.05||0.225|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.225
73967808|NCT05722704|147473115|SUPERIORITY||Median Difference (Net)|95.0|STANDARD_DEVIATION|0.05||0.424|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.424
73967809|NCT03138512|147473174|SUPERIORITY||Cox Proportional Hazard|0.95||||0.6676||95.0|0.75|1.2|||Log Rank|||||1.20|0.75|0.6676
73967810|NCT03138512|147473174|SUPERIORITY||Cox Proportional Hazard|0.93||||0.6556||95.0|0.67|1.28|||Log Rank|||||1.28|0.67|0.6556
73967811|NCT03138512|147473175|SUPERIORITY||Cox Proportional Hazard|1.26||||0.2436||95.0|0.85|1.85|||Log Rank|||Treatment Part A||1.85|0.85|0.2436
73967812|NCT03138512|147473175|SUPERIORITY||Cox Proportional Hazard|1.36||||0.45||95.0|0.61|3.07|||Log Rank|||Treatment Part B||3.07|0.61|0.4500
73967813|NCT03138512|147473177|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.89|1.67||||||||1.67|0.89|
74028434|NCT02218203|147610514|OTHER|We report the interaction between the lidocaine dose response and dextromethorphan dose response. The type of statistical test was a linear regression model with Chi-square test.|Lidocaine dose*dextromethorphan dose|0.0042|STANDARD_ERROR_OF_MEAN|0.002||0.0322|TWO_SIDED|95.0|0.0004|0.0081|||Pearson's Chi-squared test||The estimated value is an estimated interaction term, and not a P-value.|We performed a lidocaine dose response clinical trial nested within a dextromethorphan clinical trial to evaluate a potential interaction between lidocaine dose and dextromethorphan dose (pain intensity; Gracely scale).||0.0081|0.0004|0.0322
74028435|NCT04799782|147610542|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
74086886|NCT05918822|147727626|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|82.05|||||TWO_SIDED|90.0|76.84|87.61|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||87.61|76.84|
73967814|NCT03138512|147473178|SUPERIORITY||Cox Proportional Hazard|0.75||||||95.0|0.33|1.68||||||||1.68|0.33|
73967815|NCT04382404|147473199|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.63|1.15|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of Velpatasvir in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 449.39 (77.12).||1.15|0.63|
73967816|NCT04382404|147473200|OTHER||Geometric mean ratio|1.19|||||TWO_SIDED|90.0|0.88|1.6|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of Sofosbuvir in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 1226.16 (59.46).||1.60|0.88|
73967817|NCT04382404|147473201|OTHER||Geometric mean ratio|0.57|||||TWO_SIDED|90.0|0.49|0.67|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of GS-331007 in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 1312.17 (32.55).||0.67|0.49|
74028436|NCT04799782|147610543|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
74028437|NCT02606877|147610544|OTHER||T1/R1 Ratio (%)|88.58|STANDARD_DEVIATION|45.1|||TWO_SIDED|90.0|65.4|119.97|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||119.97|65.40|
73861700|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.2|||<|0.001|TWO_SIDED|95.0|-3.0|-0.1|||Miettinen and Nurminen|||Serotype 18C: Participants With IgG ≥0.35 μg/mL||-0.1|-3.0|< 0.001
73861701|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 19A: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
73861702|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.1|||Miettinen and Nurminen|||Serotype 19F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|< 0.001
73861703|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.8|||<|0.001|TWO_SIDED|95.0|-4.0|-0.2|||Miettinen and Nurminen|||Serotype 23F: Participants With IgG ≥0.35 μg/mL||-0.2|-4.0|< 0.001
73861704|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|2.0|||<|0.001|TWO_SIDED|95.0|0.4|4.3|||Miettinen and Nurminen|||Serotype 22F: Participants With IgG ≥0.35 μg/mL||4.3|0.4|<0.001
73861705|NCT04384107|147269291|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-6.8|||=|0.048|TWO_SIDED|95.0|-10.6|-3.5|||Miettinen and Nurminen|||Serotype 33F: Participants With IgG ≥0.35 μg/mL||-3.5|-10.6|= 0.048
73922789|NCT00518323|147374023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|3.17||0.508||95.0|-8.36|4.16||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||4.16|-8.36|0.508
73922790|NCT00518323|147374023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|STANDARD_ERROR_OF_MEAN|3.27||0.006||95.0|-16.58|-3.67||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||-3.67|-16.58|0.006
73922791|NCT00518323|147374023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6|STANDARD_ERROR_OF_MEAN|3.29||0.086||95.0|-13.07|-0.09||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||-0.09|-13.07|0.086
73967818|NCT04382404|147473202|OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.67|1.23|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Area under the plasma concentration versus time curve tau of Velpatasvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 3570.65 (72.04).||1.23|0.67|
74086887|NCT05918822|147727626|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|70.0|||||TWO_SIDED|90.0|60.11|81.51|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||81.51|60.11|
73861706|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.55|0.67|||Linear model|||Serotype 1: IgG GMC Ratio||0.67|0.55|< 0.001
73861707|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.85|||<|0.001|TWO_SIDED|95.0|1.67|2.05|||Linear model|||Serotype 3: IgG GMC Ratio||2.05|1.67|< 0.001
73861708|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.76|0.93|||Linear model|||Serotype 4: IgG GMC Ratio||0.93|0.76|< 0.001
73861709|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.69|0.87|||Linear model|||Serotype 5: IgG GMC Ratio||0.87|0.69|< 0.001
73861710|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.56|||=|0.019|TWO_SIDED|95.0|0.5|0.63|||Linear model|||Serotype 6A: IgG GMC Ratio||0.63|0.50|= 0.019
73861711|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.59|||=|0.015|TWO_SIDED|95.0|0.51|0.68|||Linear model|||Serotype 6B: IgG GMC Ratio||0.68|0.51|= 0.015
73861712|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.75|0.94|||Linear model|||Serotype 7F: IgG GMC Ratio||0.94|0.75|< 0.001
73861713|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.78|0.97|||Linear model|||Serotype 9V: IgG GMC Ratio||0.97|0.78|< 0.001
73861714|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.66|0.85|||Linear model|||Serotype 14: IgG GMC Ratio||0.85|0.66|< 0.001
73861715|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.82|||Linear model|||Serotype 18C: IgG GMC Ratio||0.82|0.67|< 0.001
73861716|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.65|||<|0.001|TWO_SIDED|95.0|0.59|0.72|||Linear model|||Serotype 19A: IgG GMC Ratio||0.72|0.59|< 0.001
73861717|NCT04384107|147269292|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.69|0.82|||Linear model|||Serotype 19F: IgG GMC Ratio||0.82|0.69|< 0.001
73861718|NCT04384107|147269293|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|107.45|||||TWO_SIDED|95.0|96.18|120.03||||||Serotype 22F: IgG GMC Ratio||120.03|96.18|
73861719|NCT04384107|147269293|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|32.48|||||TWO_SIDED|95.0|27.72|38.05||||||Serotype 33F: IgG GMC Ratio||38.05|27.72|
73861720|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|-0.3|||||TWO_SIDED|95.0|-1.7|0.8||||||Serotype 1: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|
73861721|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|3.3|||||TWO_SIDED|95.0|1.8|5.8||||||Serotype 3: Participants With IgG ≥0.35 μg/mL||5.8|1.8|
73861722|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|-0.3|||||TWO_SIDED|95.0|-1.7|0.8||||||Serotype 4: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|
73861723|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 5: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
73861724|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 6A: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
73861725|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 6B: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
73861726|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 7F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
73861727|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 9V: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
73922792|NCT00518323|147374024|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.968
73922793|NCT00518323|147374024|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||<0.001
73922794|NCT00518323|147374024|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.021
73922795|NCT00518323|147374025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.1||0.846||95.0|-4.54|3.73||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||3.73|-4.54|0.846
73922796|NCT00518323|147374025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|2.17|<|0.001||95.0|4.28|12.82||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||12.82|4.28|<0.001
73922797|NCT00518323|147374025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|2.18||0.067||95.0|-0.28|8.33||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||8.33|-0.28|0.067
73922798|NCT00518323|147374026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|4.27||0.058||95.0|-0.29|16.56||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||16.56|-0.29|0.058
73922799|NCT00518323|147374026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.8|STANDARD_ERROR_OF_MEAN|4.4|<|0.001||95.0|8.08|25.43||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||25.43|8.08|<0.001
73861728|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 14: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
73861729|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 18C: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
73861730|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 19A: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
73922800|NCT00518323|147374026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.5|STANDARD_ERROR_OF_MEAN|4.43||0.003||95.0|4.76|22.23||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||22.23|4.76|0.003
73922801|NCT00518323|147374027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|4.15||0.237||95.0|-13.11|3.26||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||3.26|-13.11|0.237
73861731|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 19F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
73861732|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.3|||||TWO_SIDED|95.0|-1.1|1.9||||||Serotype 23F: Participants With IgG ≥0.35 μg/mL||1.9|-1.1|
73922802|NCT00518323|147374027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|4.28||0.119||95.0|-15.15|1.74||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||1.74|-15.15|0.119
74028438|NCT02606877|147610545|OTHER||T1/R1 Ratio (%)|80.63|STANDARD_DEVIATION|74.6|||TWO_SIDED|90.0|51.27|126.79|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||126.79|51.27|
74028439|NCT02606877|147610546|OTHER||T2/R2 Ratio (%)|97.17|STANDARD_DEVIATION|14.1|||TWO_SIDED|90.0|87.84|107.48|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||107.48|87.84|
73922803|NCT00518323|147374027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.34||0.574||95.0|-11.0|6.11||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||6.11|-11.00|0.574
74028440|NCT02606877|147610547|OTHER||T2/R2 Ratio (%)|99.49|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|87.94|112.56|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||112.56|87.94|
74028441|NCT02606877|147610548|OTHER||T1/R1 Ratio (%)|89.49|STANDARD_DEVIATION|44.3|||TWO_SIDED|90.0|66.33|120.73|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||120.73|66.33|
74028442|NCT02989727|147610549|SUPERIORITY||ANOVA estimate|1.88|STANDARD_ERROR_OF_MEAN|3.51||0.59|TWO_SIDED||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.||||.59
74028443|NCT02989727|147610550|SUPERIORITY||ANOVA estimate|0.5|STANDARD_ERROR_OF_MEAN|2.56||0.84|TWO_SIDED||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.||||.84
74028444|NCT02989727|147610551|SUPERIORITY||Cox Proportional Hazard|1.2|STANDARD_ERROR_OF_MEAN|0.1||0.08|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."||||.08
74086888|NCT05918822|147727627|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|99.94|||||TWO_SIDED|90.0|94.12|106.11|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUC0-infinity of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||106.11|94.12|
73861733|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|94.8|||||TWO_SIDED|95.0|91.8|96.7||||||Serotype 22F: Participants With IgG ≥0.35 μg/mL||96.7|91.8|
74028445|NCT02989727|147610551|SUPERIORITY||Cox Proportional Hazard|1.08|STANDARD_ERROR_OF_MEAN|0.12||0.53|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."||||.53
74028446|NCT02989727|147610559|SUPERIORITY||Cox Proportional Hazard|1.27|STANDARD_ERROR_OF_MEAN|0.11||0.02|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."||||.02
74028447|NCT02989727|147610559|SUPERIORITY||Cox Proportional Hazard|1.05|STANDARD_ERROR_OF_MEAN|0.13||0.73|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."||||.73
74028448|NCT04192448|147610590|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|1.82||||0.28|TWO_SIDED|95.0|-29.82|26.19|||t-test, 1 sided|This t-test examined the difference in sexual aggression intentions between those in the Alcohol condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of sexual aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||26.19|-29.82|.28
74086889|NCT05918822|147727627|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|81.68|||||TWO_SIDED|90.0|76.93|86.73||||||Comparison of AUC0-infinity of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||86.73|76.93|
74086890|NCT05918822|147727627|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|88.92|||||TWO_SIDED|90.0|76.94|102.78|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUC0-infinity of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||102.78|76.94|
74086891|NCT00572039|147727669|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.079||||0.47|TWO_SIDED|95.0|-0.14|0.29|||ANCOVA|||To test the efficacy of PST to improve TVF functional reserve measures at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average TVF scores were examined, adjusting for baseline TVF score and the vision severity stratification variable. To approximate an interval scale and compensate for ceiling and floor effects, we linearized TVF scores using a logit transform. 106 PST and 112 ST participants provided data at 3 months.||0.29|-0.14|.47
74086892|NCT00572039|147727670|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4||||0.7|TWO_SIDED|95.0|-1.96|2.77|||ANCOVA|||To test the efficacy of PST to improve NE-VFQ scores at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average NEI-VFQ scores were examined, adjusting for baseline score and the vision severity stratification variable.||2.77|-1.96|.7
74086893|NCT03852524|147727673|SUPERIORITY||Median Difference (Net)|11.0||||0.81|TWO_SIDED||||||Log Rank|||The sample size (41 patients per study group; 82 patients total) for this superiority trial was calculated with a power of 90% (alpha = 0.05) and based on the assumption that 50% of subjects in the placebo group would experience a bowel movement by postoperative day 3, as compared to 85% in the treatment group. Additionally, a 10% lost-to-follow up rate was assumed.||||0.81
74086894|NCT02973321|147727677|OTHER|The overall Type 1 error for multiple comparisons of the HbA1c and body weight was controlled by a Hierarchical testing procedure. Testing was performed in following sequence: 1. 1st trend test for HbA1c, 2. 1st trend test for body weight, 3. 2nd trend test for HbA1c, 4. 2nd trend test for body weight, 5. 3rd trend test for HbA1c, 6. 3rd trend test for body weight.|||||<|0.0001||||||Hierarchical testing procedure continued only, if the previous comparison was statistically significant. Threshold for significance at 0.05 level.|ANCOVA|1st trend test||Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Overall 1st trend test based on a contrast with coefficients of +3, +1, -1, -3 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide. Here it is test 1 of testing order.||||< 0.0001
74086895|NCT02973321|147727677|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-0.956|STANDARD_ERROR_OF_MEAN|0.206|<|0.0001|TWO_SIDED|95.0|-1.359|-0.552||Threshold for significance at 0.05 level.|ANCOVA|2nd Trend test||Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Second Trend test based on a contrast with coefficients of 0, +1, 0, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 3 of hierarchical testing sequence.||-0.552|-1.359|< 0.0001
74086896|NCT02973321|147727677|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-0.854|STANDARD_ERROR_OF_MEAN|0.209|<|0.0001|TWO_SIDED|95.0|-1.264|-0.444||Threshold for significance at 0.05 level.|ANCOVA|3rd Trend test||Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Third Trend test based on a contrast with coefficients of 0, 0, +1, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 5 of hierarchical testing sequence.||-0.444|-1.264|< 0.0001
74086897|NCT02973321|147727678|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.||||||0.0012||||||Threshold for significance at 0.05 level.|ANCOVA|1st Trend test||Placebo, SAR425899 0.12,0.16,0.20 mg: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 2 of hierarchical testing sequence.||||0.0012
73922804|NCT01086540|147374028|SUPERIORITY||Median Difference (Final Values)|23.1|STANDARD_ERROR_OF_MEAN|14.71||0.12|TWO_SIDED||||||Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 24.|The null hypothesis was that the mean change in 6MWD between baseline and Week 24 does not differ between rituximab and placebo. A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 24.||||0.12
73922805|NCT01086540|147374029|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.71||0.42|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis|||A repeated measures mixed model was fit with PVR as the outcome and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.42
73861734|NCT04384107|147269294|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|88.5|||||TWO_SIDED|95.0|84.5|91.6||||||Serotype 33F: Participants With IgG ≥0.35 μg/mL||91.6|84.5|
73922806|NCT01086540|147374030|SUPERIORITY||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|15.1||0.28|TWO_SIDED|||||Week 48 value. P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 48.||||0.28
73922807|NCT01086540|147374030|SUPERIORITY||Mean Difference (Final Values)|25.1|STANDARD_ERROR_OF_MEAN|11.5||0.031|TWO_SIDED|||||Week 24 value. P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 24.|A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 48.||||0.031
73922808|NCT01086540|147374031|SUPERIORITY|||||||0.92||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to clinical worsening were compared using a log-rank test.||||0.92
73861735|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.53|||||TWO_SIDED|95.0|0.47|0.59||||||Serotype 1: IgG GMC Ratio||0.59|0.47|
73922809|NCT01086540|147374032|SUPERIORITY|||||||0.36||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to change or addition of PAH medications were compared using a log-rank test.||||0.36
73922810|NCT01086540|147374033|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.7||0.81|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with the mental component score as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.81
73922811|NCT01086540|147374034|SUPERIORITY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|2.1||0.3|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with the physical component score as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.30
73922812|NCT01086540|147374035|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.58|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with HAQ-DI as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.58
73922813|NCT01086540|147374036|SUPERIORITY|||||||0.47||||||P-values not adjusted for multiple comparisons.|Regression, Linear|||A Poisson model was used to describe the rate of new digital ulcers (per week) as the outcome with treatment, number of digital ulcers at Baseline, and if the measurement was affected by changed or new PAH therapeutic agents as covariates.||||0.47
73922814|NCT01086540|147374037|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|5.7||0.43|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with severity of Raynaud's (0 to 100) as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.43
73922815|NCT01086540|147374038|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.8||0.65|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with DLCO as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.65
73922816|NCT01086540|147374040|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|9.7||0.42|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis|||A repeated measures mixed model was fit with percent change in PVR as the outcome and baseline PVR, treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.42
73922817|NCT01086540|147374045|SUPERIORITY|||||||0.17||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to all-cause mortality were compared using a log-rank test.||||0.17
73922818|NCT01086540|147374046|SUPERIORITY|||||||0.35||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to all-cause mortality were compared using a log-rank test.||||0.35
73922819|NCT04949165|147374152|NON_INFERIORITY|The study employed a non-inferiority design with a non-inferiority margin of 1 g/dL for haemoglobin levels at 4 months, a 1-sided alpha level of 0.025, at least 85% power and under the assumption that the true difference in the means was 0.3 g/dL. The estimated sample size also allowed for up to 10% loss to follow- up or iron supplementation for those initially not requiring supplements, thus the sample size was 292.||||||0.025||||||Non-inferiority threshold of -1 g/dL for the lower bound of the 97.5% CI.|t-test, 1 sided|||||||0.025
73967819|NCT04382404|147473203|OTHER||Geometric mean ratio|1.39|||||TWO_SIDED|90.0|1.06|1.78||||||Area under the plasma concentration versus time curve tau of Sofosbuvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 1483.83 (66.43).|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|1.78|1.06|
74086898|NCT02973321|147727678|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant|LS Mean difference|-3.57|STANDARD_ERROR_OF_MEAN|0.887|<|0.0001|TWO_SIDED|95.0|-5.309|-1.832||Threshold for significance at 0.05 level.|ANCOVA|2nd Trend test||SAR425899 0.16 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 4 of hierarchical testing sequence.||-1.832|-5.309|< 0.0001
74086899|NCT02973321|147727678|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-2.517|STANDARD_ERROR_OF_MEAN|0.891||0.0047|TWO_SIDED|95.0|-4.264|-0.77||Threshold for significance at 0.05 level.|ANCOVA|3rd Trend test||3rd Trend Test: SAR425899 0.12 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 6 of hierarchical testing sequence.||-0.77|-4.264|0.0047
74086900|NCT03297294|147727699|SUPERIORITY|at week 12|least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.101|TWO_SIDED|95.0|-1.4|0.1|||ANCOVA|||||0.1|-1.4|0.101
73922820|NCT06273124|147374153|SUPERIORITY||Kaplan-Meier 7 Day Survival Estimate|95.0|||<|0.001|TWO_SIDED|95.0|94.0|97.0|||Bootstrapping Kaplan-Meier estimates|||Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.||97|94|<0.001
73922821|NCT06273124|147374154|SUPERIORITY||Kaplan-Meier 7 Day Survival Estimate|95.0|||<|0.001|TWO_SIDED|95.0|93.0|96.0|||Bootstrapping Kaplan-Meier estimates|||Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.||96|93|<0.001
73922822|NCT00894322|147374421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.269||0.0013|TWO_SIDED|95.0|-1.5|-0.4||Treatment group and HbA1c stratum at screening were factors. Placebo was reference group.|ANOVA|||||-0.40|-1.50|0.0013
73922823|NCT00894322|147374422|SUPERIORITY_OR_OTHER|||||||0.0033|||||||Cochran-Mantel-Haenszel|Adjusted for HbA1c strata at screening.||||||0.0033
73922824|NCT00894322|147374423|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.835||0.2285|TWO_SIDED|95.0|-2.73|0.68|||ANOVA|treatment group and HbA1c stratum at screening were factors.||Least square mean (LS) mean, 95% confidence interval (CI) and p-value calculated for the changes in weight from baseline in participants in cohort 2 treated with exenatide with placebo as reference group.||0.68|-2.73|0.2285
73922825|NCT00894322|147374424|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.4|STANDARD_ERROR_OF_MEAN|12.8||0.0035|TWO_SIDED|95.0|-66.5|-14.3|||ANOVA|treatment group and HbA1c stratum at screening were factors.||||-14.3|-66.5|0.0035
73922826|NCT00399360|147374496|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||||||0.37
73922827|NCT00399360|147374497|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
73922828|NCT00399360|147374498|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.08
73922829|NCT00399360|147374499|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||||||0.13
73922830|NCT00399360|147374500|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
74086901|NCT03297294|147727700|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.168|TWO_SIDED|95.0|-1.3|0.2|||ANCOVA|||At week 12||0.2|-1.3|0.168
74086902|NCT03297294|147727704|SUPERIORITY||Odds Ratio (OR)|1.6||||0.255|TWO_SIDED|95.0|0.7|3.9|||Regression, Logistic|||Week 12||3.9|0.7|0.255
74086903|NCT03297294|147727705|SUPERIORITY||Odds Ratio (OR)|2.8||||0.1|TWO_SIDED|95.0|0.8|9.6|||Regression, Logistic|||||9.6|0.8|0.100
74086904|NCT02563769|147727739|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
73922831|NCT00399360|147374501|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
73922832|NCT00399360|147374502|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||||||0.10
73922833|NCT00399360|147374503|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|||||||0.63
73922834|NCT00399360|147374504|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
73922835|NCT00399360|147374505|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
73922836|NCT01412021|147374506|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
73922837|NCT01412021|147374507|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
73922838|NCT01412021|147374508|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
73922839|NCT01412021|147374509|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
73922840|NCT01412021|147374510|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
73922841|NCT01412021|147374512|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
73922842|NCT01412021|147374514|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
73922843|NCT01412021|147374515|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
73922844|NCT01412021|147374516|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922845|NCT01412021|147374517|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922846|NCT01412021|147374518|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922847|NCT01412021|147374519|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922848|NCT01412021|147374520|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922849|NCT01412021|147374521|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922850|NCT01412021|147374522|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922851|NCT01412021|147374523|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922852|NCT01412021|147374524|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
74086905|NCT02563769|147727739|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
74086906|NCT01610063|147727755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Comparison for QIDS-C16||||<0.0001
74086907|NCT01610063|147727756|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups for HAMD-17||||<0.0001
73861736|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|1.71|||||TWO_SIDED|95.0|1.53|1.9||||||Serotype 3: IgG GMC Ratio||1.90|1.53|
73861737|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05||||||Serotype 4: IgG GMC Ratio||1.05|0.80|
73922853|NCT01412021|147374526|SUPERIORITY|||||||0.0132|||||||paired t-test|||||||0.0132
73922854|NCT01412021|147374527|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922855|NCT01412021|147374528|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73967820|NCT04382404|147473204|OTHER||Geometric mean ratio|0.62|||||TWO_SIDED|90.0|0.55|0.71||||||Area under the plasma concentration versus time curve tau of Sofosbuvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 15361.31 (22.35).|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|0.71|0.55|
73967821|NCT04382404|147473205|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|95.0|0.91|2.25||||||The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|2.25|0.91|
73967822|NCT04382404|147473206|OTHER||Geometric mean ratio|1.91|||||TWO_SIDED|95.0|1.14|3.19|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.||3.19|1.14|
73967823|NCT04382404|147473207|OTHER||Geometric mean ratio|1.5|||||TWO_SIDED|95.0|0.87|2.6|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.||2.60|0.87|
73967824|NCT04382404|147473208|OTHER||Geometric mean ratio|0.53|||||TWO_SIDED|95.0|0.5|0.56|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.56|.50|
73967825|NCT04382404|147473209|OTHER||Geometric mean ratio|0.53|||||TWO_SIDED|95.0|0.49|0.58|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.58|.49|
73967826|NCT04382404|147473210|OTHER||Geometric mean ratio|0.55|||||TWO_SIDED|95.0|0.48|0.64|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.64|.48|
73967827|NCT05687916|147473240|SUPERIORITY||LS Mean Difference Estimate|-0.24|STANDARD_ERROR_OF_MEAN|3.277|=|0.989|TWO_SIDED|95.0|-6.67|6.18||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||6.18|-6.67|=0.989
73861738|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.67|||||TWO_SIDED|95.0|0.59|0.75||||||Serotype 5: IgG GMC Ratio||0.75|0.59|
73967828|NCT05687916|147473240|SUPERIORITY||LS Mean Difference Estimate|2.4|STANDARD_ERROR_OF_MEAN|3.227|=|0.916|TWO_SIDED|95.0|-3.93|8.72||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||8.72|-3.93|=0.916
73861739|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.64|||||TWO_SIDED|95.0|0.56|0.73||||||Serotype 6A: IgG GMC Ratio||0.73|0.56|
73861740|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.74|||||TWO_SIDED|95.0|0.65|0.84||||||Serotype 6B: IgG GMC Ratio||0.84|0.65|
73922856|NCT01412021|147374529|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922857|NCT01412021|147374530|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922858|NCT01412021|147374531|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922859|NCT01412021|147374532|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922860|NCT01412021|147374533|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922861|NCT01412021|147374534|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922862|NCT01412021|147374535|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
73922863|NCT04262232|147374563|SUPERIORITY||Mean Difference (Net)|-1.8||||0.0001|TWO_SIDED|95.0|-2.6|-0.95|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||-0.95|-2.6|0.0001
73922864|NCT04262232|147374564|SUPERIORITY||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|1.17|1.63|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||1.63|1.17|<0.0001
73922865|NCT04262232|147374566|SUPERIORITY||Mean Difference (Net)|-2.8||||0.01|TWO_SIDED|95.0|-4.99|-0.61|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||-0.61|-4.99|0.01
73922866|NCT04262232|147374568|SUPERIORITY||Mean Difference (Net)|0.5||||0.51|TWO_SIDED|95.0|-1.02|2.02|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||2.02|-1.02|0.51
73922867|NCT00670800|147374583|SUPERIORITY_OR_OTHER|||||||0.143||95.0|||||t-test, 2 sided|||||||0.143
73922868|NCT00670800|147374583|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||||||0.900
73922869|NCT00670800|147374583|SUPERIORITY_OR_OTHER|||||||0.133||95.0|||||t-test, 2 sided|||||||0.133
73922870|NCT00670800|147374584|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||||||0.049
73922871|NCT00670800|147374584|SUPERIORITY_OR_OTHER|||||||0.717||95.0|||||t-test, 2 sided|||||||0.717
73922872|NCT00670800|147374584|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||||||0.038
73922873|NCT00670800|147374585|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||t-test, 2 sided|||||||0.498
73922874|NCT00670800|147374585|SUPERIORITY_OR_OTHER|||||||0.835||95.0|||||t-test, 2 sided|||||||0.835
73922875|NCT00670800|147374585|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||t-test, 2 sided|||||||0.606
73922876|NCT00670800|147374586|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||t-test, 2 sided|||||||0.118
73922877|NCT00670800|147374586|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||t-test, 2 sided|||||||0.581
73967829|NCT05687916|147473241|SUPERIORITY||LS Mean Difference Estimate|-0.32|STANDARD_ERROR_OF_MEAN|1.656|=|0.989|TWO_SIDED|95.0|-3.57|2.92||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.|LS in LS Mean Difference denotes least squares.|||2.92|-3.57|=0.989
74086908|NCT01610063|147727757|OTHER|||||||0.002|||||||t-test, 2 sided|||Comparison for PHQ-9||||0.002
74086909|NCT02105701|147727831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
74086910|NCT02105701|147727831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
73922878|NCT00670800|147374586|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||t-test, 2 sided|||||||0.190
73922879|NCT04736199|147374587|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.0001|TWO_SIDED|95.0|0.413|0.707||One-sided|Log Rank|||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.707|0.413|<0.0001
73922880|NCT04736199|147374588|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.1007|TWO_SIDED|95.0|0.591|1.118||One-sided|Log Rank||significance level of 0.0185 (one-sided)|Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||1.118|0.591|0.1007
73922881|NCT04736199|147374589|OTHER||Hazard Ratio (HR)|0.404|||||TWO_SIDED|95.0|0.321|0.508||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.508|0.321|
73922882|NCT04736199|147374590|OTHER||Hazard Ratio (HR)|0.401|||||TWO_SIDED|95.0|0.288|0.558||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.558|0.288|
73922883|NCT04736199|147374591|OTHER||Hazard Ratio (HR)|0.306|||||TWO_SIDED|95.0|0.231|0.405||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.405|0.231|
73922884|NCT04736199|147374592|OTHER||Rate difference|44.3|||||TWO_SIDED|95.0|37.4|51.2||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||51.2|37.4|
73922885|NCT04736199|147374593|OTHER||Hazard Ratio (HR)|0.721|||||TWO_SIDED|95.0|0.544|0.957||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.957|0.544|
73922886|NCT04318080|147374595|SUPERIORITY|Analysis tested whether ORR with tislelizumab was superior to a historical ORR of 45% using a one-sided binomial exact test (α = 0.05).|Z-test|2.62||||0.0044|TWO_SIDED|||||One-sided p-value based on a binomial exact test comparing observed ORR to historical rate of 45%.|Binomial Exact Test|||The primary analysis was conducted on both cohorts combined, A binomial exact test was performed to test the null hypothesis (H0: ORR = 45% based on previous clinical trials) and alternative hypothesis (ORR \>45%). If the one-sided p-value was ≤ 0.05, tislelizumab was considered to statistically significantly increase ORR compared to the historical control.||||0.0044
73922887|NCT01921179|147374650|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on neurocognitive performance Attention and Executive Function Overall Domain Z Score|||||<|0.01|||||||ANOVA|||||||<0.01
73922888|NCT01921179|147374651|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare neurocognitive performance on Overall Attention /Executive Function overall score at baseline and at 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA|Repeated measure MANOVA was used to compare performance on neurocognitive domain scores at baseline and at 6+ month follow-up post-GOALS training||||||<0.001
73922889|NCT01921179|147374652|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance|||||>|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance||||||>0.05
73922890|NCT01921179|147374653|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare performance on Goal Processing Scale Overall domain scores at baseline and 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA|||||||<0.001
73922891|NCT01921179|147374654|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on emotional regulation measures - POMS Total score|||||<|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS versus the BHE training on emotional regulation measures - POMS Total score||||||<0.05
73922892|NCT01921179|147374655|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare participants' self-report on POMS Total Mood Disturbance overall score at baseline and 6+ month post-GOALS training follow-up|||||<|0.01|||||||ANOVA|||||||<0.01
73922893|NCT01466348|147374765|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.6||||0.0008|TWO_SIDED|95.0|1.5|5.6|||ANOVA|No baseline covariate adjustment was carried out.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||5.6|1.5|0.0008
73922894|NCT01466348|147374766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.5|||<|0.0001|TWO_SIDED|95.0|4.5|8.4|||ANOVA|No baseline covariate adjustment was applied.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||8.4|4.5|<0.0001
73922895|NCT03989440|147374787|SUPERIORITY||LS Mean Difference|0.54||||0.59|TWO_SIDED|95.0|-1.48|2.55|||Mixed Models Analysis|||||2.55|-1.48|0.59
73922896|NCT03989440|147374788|SUPERIORITY||LS Mean Difference|-1.56||||0.13|TWO_SIDED|95.0|-3.62|0.5|||Mixed Models Analysis|||||0.50|-3.62|0.13
73922897|NCT03989440|147374789|SUPERIORITY||LS Mean Difference|-1.16||||0.16|TWO_SIDED|95.0|-2.81|0.5|||Mixed Models Analysis|||||0.50|-2.81|0.16
73922898|NCT03989440|147374790|SUPERIORITY||% Difference in responder rate|-9.3||||0.68|TWO_SIDED|95.0|-43.3|25.4|||Fisher Exact|||||25.4|-43.3|0.68
73922899|NCT01955161|147374840|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.9591|TWO_SIDED|95.0|-0.59|1.26||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.26|-0.59|0.9591
73922900|NCT01955161|147374840|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||1|TWO_SIDED|95.0|-0.88|0.98||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.98|-0.88|1.000
73922901|NCT01955161|147374841|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.37|1.21||Corrected for multiplicity according toe the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.21|-1.37|1.000
73967830|NCT05687916|147473241|SUPERIORITY||LS Mean Difference Estimate|-3.06|STANDARD_ERROR_OF_MEAN|1.59|=|0.216|TWO_SIDED|95.0|-6.18|0.06||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||0.06|-6.18|=0.216
73967831|NCT03332017|147473243|SUPERIORITY|||||||0.0017|||||||Cochran-Mantel-Haenszel|P-value was stratified by rituximab-refractory status, number of prior lines of therapy, and geographic region per interactive response technology.||||||0.0017
73967832|NCT01809691|147473296|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.08|TWO_SIDED|95.0|0.72|1.02|||Regression, Cox|||||1.02|0.72|.080
73967833|NCT01809691|147473297|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.51|0.67|||Regression, Cox|||||0.67|0.51|<0.001
73967834|NCT03661840|147473301|SUPERIORITY||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|17.0||0.82|TWO_SIDED|95.0|-31.0|39.0||Unadjusted model comparing the mean difference (change from 12 weeks - baseline) in outcome by intervention group.|Regression, Linear|||Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.||39|-31|0.82
73967835|NCT03661840|147473302|SUPERIORITY||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|6.4||0.06|TWO_SIDED|95.0|-0.7|25.0||Unadjusted model comparing the change in outcome by intervention group|Regression, Linear|||||25|-0.7|0.06
73967836|NCT03661840|147473302|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.05|TWO_SIDED||||||ANOVA|||Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.||||0.05
73967837|NCT04401800|147473313|SUPERIORITY|||||||0.0002|||||||Binomial exact test|||||||0.0002
73967838|NCT04401800|147473315|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||||||< 0.0001
73967839|NCT04401800|147473316|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by the Investigator||||< 0.0001
73861741|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.92||||||Serotype 7F: IgG GMC Ratio||0.92|0.71|
73861742|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.73|0.94||||||Serotype 9V: IgG GMC Ratio||0.94|0.73|
73861743|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||Serotype 14: IgG GMC Ratio||0.96|0.74|
73861744|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.14||||||Serotype 18C: IgG GMC Ratio||1.14|0.87|
73861745|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92||||||Serotype 19A: IgG GMC Ratio||0.92|0.73|
73861746|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.75|0.94||||||Serotype 19F: IgG GMC Ratio||0.94|0.75|
73861747|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.7||||||Serotype 23F: IgG GMC Ratio||0.70|0.52|
73861748|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|86.74|||||TWO_SIDED|95.0|77.61|96.95||||||Serotype 22F: IgG GMC Ratio||96.95|77.61|
73861749|NCT04384107|147269295|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|45.44|||||TWO_SIDED|95.0|40.07|51.54||||||Serotype 33F: IgG GMC Ratio||51.54|40.07|
73861750|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.66|||||TWO_SIDED|95.0|0.55|0.78||||||Serotype 1: OPA GMT Ratio||0.78|0.55|
73922902|NCT01955161|147374841|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.29|1.31||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.31|-1.29|1.000
73922903|NCT01955161|147374842|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.15|0.2||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.20|-0.15|1.000
74086911|NCT02105701|147727831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
73861751|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.23|1.59||||||Serotype 3: OPA GMT Ratio||1.59|1.23|
73861752|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1||||||Serotype 4: OPA GMT Ratio||1.10|0.85|
73861753|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.8|1.04||||||Serotype 5: OPA GMT Ratio||1.04|0.80|
73861754|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 6A: OPA GMT Ratio||0.89|0.65|
73861755|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.69|0.95||||||Serotype 6B: OPA GMT Ratio||0.95|0.69|
73861756|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.95||||||Serotype 7F: OPA GMT Ratio||0.95|0.70|
73861757|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 9V: OPA GMT Ratio||0.94|0.71|
73861758|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.97|1.38||||||Serotype 14: OPA GMT Ratio||1.38|0.97|
73861759|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.11||||||Serotype 18C: OPA GMT Ratio||1.11|0.90|
73861760|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.68|||||TWO_SIDED|95.0|0.61|0.77||||||Serotype 19A: OPA GMT Ratio||0.77|0.61|
73922904|NCT01955161|147374842|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.34|0.02||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, ADAS-cog total score and either ADCS-ADL23 total score or ADCS CGIC had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.02|-0.34|1.000
73922905|NCT01245270|147374851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"For the incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed.~Values obtained following the control and extract capsules were compared by paired t-tests."|t-test, 2 sided|||||||0.003
73922906|NCT01245270|147374852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028||95.0||||For incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed. Values obtained following the control and extract capsules were compared by paired t-tests.|t-test, 2 sided|||||||0.028
73922907|NCT01277523|147374861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.055||0.0457|TWO_SIDED|95.0|0.002|0.22||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.220|0.002|0.0457
73922908|NCT01277523|147374861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.055||0.1039|TWO_SIDED|95.0|-0.019|0.198||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.198|-0.019|0.1039
73922909|NCT01277523|147374862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.059||0.0509|TWO_SIDED|95.0|0.0|0.231||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.231|-0.000|0.0509
73922910|NCT01277523|147374862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.058||0.3605|TWO_SIDED|95.0|-0.061|0.168||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.168|-0.061|0.3605
73922911|NCT01277523|147374863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.059||0.1264|TWO_SIDED|95.0|-0.026|0.207|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.207|-0.026|0.1264
73922912|NCT01277523|147374863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.059||0.2845|TWO_SIDED|95.0|-0.053|0.179|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.179|-0.053|0.2845
73922913|NCT01277523|147374864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.053||0.0338|TWO_SIDED|95.0|0.009|0.217|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.217|0.009|0.0338
73922914|NCT01277523|147374864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.053||0.0999|TWO_SIDED|95.0|-0.017|0.191|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.191|-0.017|0.0999
73922915|NCT01277523|147374865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.057||0.1252|TWO_SIDED|95.0|-0.024|0.198|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.198|-0.024|0.1252
73922916|NCT01277523|147374865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.056||0.3549|TWO_SIDED|95.0|-0.058|0.163|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.163|-0.058|0.3549
73922917|NCT01277523|147374866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.088||0.1819|TWO_SIDED|95.0|-0.055|0.292|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.292|-0.055|0.1819
73922918|NCT01277523|147374866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.088||0.5448|TWO_SIDED|95.0|-0.119|0.226|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.226|-0.119|0.5448
73922919|NCT01277523|147374868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.082||0.4762|TWO_SIDED|95.0|-0.102|0.219|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.219|-0.102|0.4762
73922920|NCT01277523|147374868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.081||0.6558|TWO_SIDED|95.0|-0.123|0.196|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.196|-0.123|0.6558
73967840|NCT04401800|147473316|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by Central Site Imaging Facility||||< 0.0001
73861761|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.04||||||Serotype 19F: OPA GMT Ratio||1.04|0.84|
73922921|NCT01277523|147374870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.153||0.996|TWO_SIDED|95.0|-0.301|0.3|||Mixed Models Analysis|||||0.300|-0.301|0.9960
73922922|NCT01277523|147374870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.151||0.703|TWO_SIDED|95.0|-0.355|0.239|||Mixed Models Analysis|||||0.239|-0.355|0.7030
73922923|NCT01277523|147374871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.094||0.7309|TWO_SIDED|95.0|-0.217|0.153|||Mixed Models Analysis|||||0.153|-0.217|0.7309
73922924|NCT01277523|147374871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.093||0.5954|TWO_SIDED|95.0|-0.232|0.133|||Mixed Models Analysis|||||0.133|-0.232|0.5954
73922925|NCT01277523|147374872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.083||0.2841|TWO_SIDED|95.0|-0.074|0.252|||Mixed Models Analysis|||||0.252|-0.074|0.2841
73922926|NCT01277523|147374872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.082||0.795|TWO_SIDED|95.0|-0.14|0.182|||Mixed Models Analysis|||||0.182|-0.140|0.7950
73922927|NCT01277523|147374873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.9671|TWO_SIDED|95.0|0.07|16.95|||Regression, Cox|||||16.95|0.07|0.9671
73967841|NCT04401800|147473317|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by the Investigator||||< 0.0001
73922928|NCT01277523|147374873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.5557|TWO_SIDED|95.0|0.19|22.7|||Regression, Cox|||||22.70|0.19|0.5557
74086912|NCT02105701|147727831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
74086913|NCT02105701|147727834|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
73922929|NCT01277523|147374874|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.3567|TWO_SIDED|95.0|0.41|1.38|||Regression, Cox|||||1.38|0.41|0.3567
73922930|NCT01277523|147374874|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1168|TWO_SIDED|95.0|0.32|1.14|||Regression, Cox|||||1.14|0.32|0.1168
73922931|NCT03928847|147374876|SUPERIORITY|The mean EGCG blood levels were compared among 450 mg, 600 mg, and 750 mg groups.|Mean Difference (Net)|250.0|||||TWO_SIDED|||||||||||||
73922932|NCT03928847|147374877|OTHER|ELISA data from each patient before and after EGCG treatment were compared and analyzed with the use of the Wilcoxon signed-rank test (two-tailed).|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73922933|NCT03928847|147374878|OTHER|ELISA data from each patient before and after EGCG treatment were compared and analyzed with the use of the Wilcoxon signed-rank test (two-tailed).|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73922934|NCT03928847|147374879|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
73922935|NCT03928847|147374880|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
73922936|NCT03928847|147374881|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
73922937|NCT01881230|147374882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.692||||0.0183|TWO_SIDED|95.0|1.089|2.629|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||2.629|1.089|0.0183
73922938|NCT01881230|147374882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.581||||0.0152|TWO_SIDED|95.0|0.373|0.904|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||0.904|0.373|0.0152
73922939|NCT01881230|147374882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8599|TWO_SIDED|95.0|0.676|1.597|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||1.597|0.676|0.8599
73922940|NCT01881230|147374885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.375||||0.1579|TWO_SIDED|95.0|0.882|2.143|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||2.143|0.882|0.1579
73922941|NCT01881230|147374885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.2945|TWO_SIDED|95.0|0.52|1.221|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||1.221|0.520|0.2945
73922942|NCT01881230|147374885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.101||||0.6691|TWO_SIDED|95.0|0.71|1.708|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||1.708|0.710|0.6691
73922943|NCT00112502|147374889|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.8|1.7||||||||1.7|0.8|
73922944|NCT00112502|147374890|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.6|1.2||||||||1.2|0.6|
73922945|NCT00112502|147374891|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|1.8||||||||1.8|0.9|
73922946|NCT00112502|147374892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.6|1.3||||||||1.3|0.6|
73922947|NCT00112502|147374894|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.5||||||||1.5|0.7|
73922948|NCT00112502|147374895|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
73922949|NCT00112502|147374896|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.8|1.8||||||||1.8|0.8|
73922950|NCT00112502|147374897|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.1||||||||1.1|0.5|
73922951|NCT00870363|147374915|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
73922952|NCT02357901|147374922|SUPERIORITY||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test|||||||<0.0001
73922953|NCT02357901|147374922|SUPERIORITY||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test|||||||<0.0001
73922954|NCT02357901|147374923|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel|||||||<0.0001
73922955|NCT02357901|147374923|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel|||||||<0.0001
73922956|NCT02357901|147374924|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
73922957|NCT02357901|147374924|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
73922958|NCT02357901|147374925|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
73922959|NCT02357901|147374925|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
73967842|NCT04401800|147473317|SUPERIORITY|||||||0.0002|||||||Binomial exact test|||ORR as Assessed by Central Site Imaging Facility||||0.0002
74086914|NCT02105701|147727834|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
74086915|NCT02105701|147727834|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
74086916|NCT02105701|147727834|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
74086917|NCT02148445|147727835|SUPERIORITY|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%.||||||0.88|||||||Chi-squared|||||||0.88
73922960|NCT02357901|147374926|SUPERIORITY||LSM difference|-9.4|STANDARD_ERROR_OF_MEAN|2.62||0.0003|TWO_SIDED|95.0|-14.56|-4.3||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-4.30|-14.56|0.0003
73922961|NCT02357901|147374926|SUPERIORITY||LSM difference|-12.4|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-17.51|-7.28||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-7.28|-17.51|<0.0001
73922962|NCT02357901|147374927|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
73922963|NCT02357901|147374927|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
73922964|NCT02357901|147374928|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
73922965|NCT02357901|147374928|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
73967843|NCT05671029|147473341|NON_INFERIORITY|Null hypothesis: difference to placebo of change from baseline QTcF ≥ 10 ms.|Prediction @ mean max concentration|0.8|||<|0.05|TWO_SIDED|90.0|-1.3|2.9|||Mixed Models Analysis|||||2.9|-1.3|<0.05
73967844|NCT02651428|147473365|SUPERIORITY||Hazard Ratio (HR)|0.29||||0.0006|TWO_SIDED|95.0|0.14|0.62||The threshold significance level at the interim and final statistical analyses for the primary efficacy endpoint was 0.0294.|Log Rank||The numerator for the hazard ratio was the estimated hazard for the Neutrolin treatment arm, and the denominator was the estimated hazard for the Heparin treatment arm.|The null hypothesis was that there was no difference in the survival functions for CRBSI between the two treatments. Based on 80% power to detect a 55% reduction in the risk of CRBSI relative to the control treatment, a 1:1 randomization, a 2-sided log-rank test, one interim analysis using the method of Pocock, and an overall alpha of 0.05, it was determined that 56 CRBSIs would be needed. These are the results of the final analysis.||0.62|0.14|0.0006
74086918|NCT02148445|147727836|SUPERIORITY|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%. This sample size will provide comparable power for looking at 6 month sustained cessation.||||||0.55|||||||Chi-squared|||||||0.55
73922966|NCT02357901|147374929|SUPERIORITY||LSM difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.96|-0.46||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.46|-0.96|<0.0001
73922967|NCT02357901|147374929|SUPERIORITY||LSM difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.12|-0.62||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.62|-1.12|<0.0001
73922968|NCT02357901|147374930|SUPERIORITY||LSM difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.89|-0.33||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.33|-0.89|<0.0001
73922969|NCT02357901|147374930|SUPERIORITY||LSM difference|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.41||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.41|-0.97|<0.0001
73922970|NCT02357901|147374931|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.38||0.3143|TWO_SIDED|95.0|-1.13|0.36||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||0.36|-1.13|0.3143
73922971|NCT02357901|147374931|SUPERIORITY||LSM difference|-1.0|STANDARD_ERROR_OF_MEAN|0.38||0.0101|TWO_SIDED|95.0|-1.72|-0.23||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.23|-1.72|0.0101
73922972|NCT02357901|147374932|SUPERIORITY||LSM difference|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0726|TWO_SIDED|95.0|-3.29|0.14||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||0.14|-3.29|0.0726
73922973|NCT02357901|147374932|SUPERIORITY||LSM difference|-2.6|STANDARD_ERROR_OF_MEAN|0.87||0.0028|TWO_SIDED|95.0|-4.32|-0.9||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.90|-4.32|0.0028
73922974|NCT02357901|147374933|SUPERIORITY||LSM difference|7.5|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|5.81|9.2||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.||||9.20|5.81|<0.0001
73922975|NCT02357901|147374933|SUPERIORITY||LSM difference|7.5|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|5.82|9.21||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.||||9.21|5.82|<0.0001
73922976|NCT04259762|147374937|OTHER|This is a summary of the total number of participants in the focus groups who endorsed the particular theme.|Proportion endorsing themes|1.0|||||TWO_SIDED|||||||||All focus groups were summarized together and, therefore, the denominators (N=85 \[Community\], N=11 \[Provider\]) for each theme are the same. Further, the focus groups only made qualitative (and no quantitative) assessments/endoresement of themes. No formal comparisons among groups were made.||||
73922977|NCT04259762|147374939|OTHER|Formal statistical comparisons were not made.|Proportion endorsing attempt to screen|0.567|||||TWO_SIDED|95.0|0.303|0.831|||||"Pooled estimate of attempt to screening. Using R:~n1 \<- c(20,28,11,15,26,23,21); nt \<- c(45,50,45,50,50,50,22) p1 \<- n1/nt; v1 \<- p1\*(1-p1)/nt fit \<- lm(p1 \~ 1,weight=1/v1) summary(fit)$coef\[1\] + qt(.975,6)\*c(0,-1,1)\*summary(fit)$coef\[2\]"|||0.831|0.303|
73922978|NCT01203046|147374940|NON_INFERIORITY_OR_EQUIVALENCE|It was used for the calculation of statistical power an author of 5% level, it was felt that the difference between the minimum value of non inferiority does not exceed 10%.|Odds Ratio (OR)|2.65|||<|0.05|TWO_SIDED|95.0|0.35|19.83|||Regression, Logistic|||||19.83|0.35|<0.05
73922979|NCT01203046|147374941|NON_INFERIORITY_OR_EQUIVALENCE|Consider a 5% confidence level, the power of assigned contrast was 80% to detect a difference minima of at least 10% of equivalence between the analyzed groups.|Odds Ratio (OR)|1.18|||<|0.05|TWO_SIDED|95.0|0.21|6.51|||Regression, Logistic|||||6.51|0.21|<0.05
73922980|NCT02293655|147374943|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|2.6||0.55|TWO_SIDED||||||t-test, 2 sided|||Compared at Baseline Time point||||0.55
73922981|NCT02293655|147374943|SUPERIORITY||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|2.3||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison at MPH Maintenance Visit (Week 8)||||.30
73922982|NCT02293655|147374943|SUPERIORITY||Mean Difference (Final Values)|4.01|STANDARD_ERROR_OF_MEAN|3.9||0.28|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 1 (Week 9)||||.28
73861762|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.63|||||TWO_SIDED|95.0|0.53|0.74||||||Serotype 23F: OPA GMT Ratio||0.74|0.53|
73922983|NCT02293655|147374943|SUPERIORITY||Mean Difference (Final Values)|9.64|STANDARD_ERROR_OF_MEAN|2.5||0|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 2 (Week 10)||||.00
73922984|NCT02293655|147374943|SUPERIORITY||Mean Difference (Final Values)|7.96|STANDARD_ERROR_OF_MEAN|3.2||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 3 (Week 12)||||.01
73922985|NCT02293655|147374944|SUPERIORITY||Mean Difference (Final Values)|36.04|STANDARD_ERROR_OF_MEAN|25.4||0.32|TWO_SIDED||||||t-test, 2 sided|||Compared at baseline timepoint||||.32
73922986|NCT02293655|147374944|SUPERIORITY||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|30.1||0.9|TWO_SIDED||||||t-test, 2 sided|||Compared at Maintenance Time Point (week 8)||||.90
73922987|NCT02293655|147374944|SUPERIORITY||Mean Difference (Final Values)|100.81|STANDARD_ERROR_OF_MEAN|37.5||0.007|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 1 (week 9)||||.007
73922988|NCT02293655|147374944|SUPERIORITY||Mean Difference (Final Values)|49.07|STANDARD_ERROR_OF_MEAN|56.6||0.26|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 2 (week 10)||||.26
73922989|NCT02293655|147374944|SUPERIORITY||Mean Difference (Final Values)|123.9|STANDARD_ERROR_OF_MEAN|37.6||0.01|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 3 (week 12)||||.01
73922990|NCT02293655|147374945|SUPERIORITY||Mean Difference (Final Values)|31.13|STANDARD_ERROR_OF_MEAN|32.9||0.33|TWO_SIDED||||||t-test, 2 sided|||Comparison at Baseline||||.33
73922991|NCT02293655|147374945|SUPERIORITY||Mean Difference (Final Values)|56.86|STANDARD_ERROR_OF_MEAN|29.5||0.06|TWO_SIDED||||||t-test, 2 sided|||Comparison at Maintenance (week 8)||||.06
73922992|NCT02293655|147374945|SUPERIORITY||Mean Difference (Final Values)|108.78|STANDARD_ERROR_OF_MEAN|46.8||0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 1 (week 9)||||.05
73922993|NCT02293655|147374945|SUPERIORITY||Mean Difference (Final Values)|118.12|STANDARD_ERROR_OF_MEAN|44.2||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 2 (week 10)||||.008
73922994|NCT02293655|147374945|SUPERIORITY||Mean Difference (Final Values)|77.09|STANDARD_ERROR_OF_MEAN|42.9||0.07|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 3 (week 12)||||.07
73922995|NCT01519414|147375014|OTHER|||||||0.02|||||||Log Rank|||||||0.02
73922996|NCT00391274|147375043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.1326||95.0|0.76|8.25||Logistic regression of best overall tumor response (complete response + partial response).|Regression, Logistic|Treatment was the only covariate.||||8.25|0.76|0.1326
73922997|NCT00391274|147375044|SUPERIORITY_OR_OTHER|||||||0.7704||95.0|||||Log Rank|||||||0.7704
73922998|NCT00391274|147375044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.7784||95.0|0.75|1.46|||Regression, Cox|Treatment was the only covariate.||||1.46|0.75|0.7784
73922999|NCT00391274|147375047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.4921||95.0|0.78|1.68||P-value for Overall Survival (up to 24 months)|Regression, Cox|Treatment was the only covariate.||||1.68|0.78|0.4921
73923000|NCT00391274|147375047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9256|TWO_SIDED|95.0|0.74|1.4||P-value for Overall Survival (up to 30 months)|Regression, Cox|||||1.40|0.74|0.9256
73967845|NCT02651428|147473366|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4161|TWO_SIDED|95.0|0.9|1.29||The threshold for statistical significance was p \< 0.05.|Log Rank||The numerator for the hazard ratio was the estimated hazard for the Neutrolin treatment arm, and the denominator was the estimated hazard for the Heparin treatment arm.|The null hypothesis was that there was no difference in the time until catheter removal for any reason between the two treatments.||1.29|0.90|0.4161
73923001|NCT03341533|147375053|EQUIVALENCE|The null hypothesis is that there is no difference in NPIS between the two groups.|difference in medians|0.0||||0.39|TWO_SIDED||||||Kruskal-Wallis|||||||0.39
73923002|NCT03341533|147375054|EQUIVALENCE|The null hypothesis is that there is no difference in MME use on the hospital floor between groups.|Difference of medians|-4.5||||0.88|TWO_SIDED||||||Kruskal-Wallis||Ice packs - Usual care|||||0.88
73923003|NCT03341533|147375055|EQUIVALENCE|The null hypothesis is that the outpatient MME consumption will be the same across the two groups.|difference in medians|-7.5||||0.75|TWO_SIDED||||||Kruskal-Wallis||Ice packs - Usual Care|||||0.75
73923004|NCT03341533|147375056|EQUIVALENCE|The null hypothesis is that the postoperative BPI pain severity score will be the same between groups|difference in medians|-0.3||||0.8|TWO_SIDED||||||Kruskal-Wallis||Ice Packs - Usual Care|||||0.80
73923005|NCT04035161|147375066|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.15|0.16||||||"Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.16|-0.15|
73923006|NCT04035161|147375066|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|-0.24|||||TWO_SIDED|95.0|-0.43|-0.05||||||"Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||-0.05|-0.43|
73923007|NCT04035161|147375066|SUPERIORITY||Mean Difference (Final Values)|1.82|||||TWO_SIDED|95.0|1.66|1.97||||||"Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||1.97|1.66|
73923008|NCT04035161|147375066|SUPERIORITY||Mean Difference (Final Values)|2.38|||||TWO_SIDED|95.0|2.19|2.56||||||"Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||2.56|2.19|
73967846|NCT05592418|147473380|SUPERIORITY||Mean Difference (Final Values)|0.0288||||0.9851|TWO_SIDED|95.0|-3.0397|3.0972|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||3.0972|-3.0397|0.9851
73967847|NCT05592418|147473381|SUPERIORITY||Mean Difference (Final Values)|-1.9076||||0.3095|TWO_SIDED|95.0|-5.6279|1.8128|||ANCOVA|||||1.8128|-5.6279|0.3095
73967848|NCT05592418|147473382|SUPERIORITY||Mean Difference (Final Values)|0.6086||||0.7663|TWO_SIDED|95.0|-3.4656|4.6829|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||4.6829|-3.4656|0.7663
74086919|NCT02148445|147727837|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
74086920|NCT02148445|147727838|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73923009|NCT04035161|147375069|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.08|0.23||||||"Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.23|-0.08|
73923010|NCT04035161|147375069|SUPERIORITY||Mean Difference (Final Values)|1.99|||||TWO_SIDED|95.0|1.84|2.15||||||"Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||2.15|1.84|
73923011|NCT05778786|147375126|SUPERIORITY|A superiority margin of 0.0 logMAR was used.|Least-Square Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.012|||ONE_SIDED|95.0||-0.1|||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 9 subjects provide at least 99% statistical power to test for superiority.||-0.10||
74086921|NCT02148445|147727839|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
74086922|NCT02148445|147727840|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||||||0.39
73923012|NCT05778786|147375127|SUPERIORITY|A superiority margin of 62 points was used.|Least-quares mean|69.4|STANDARD_ERROR_OF_MEAN|2.13|||ONE_SIDED|95.0|65.2||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 165 subjects provide at least 99% statistical power to test for superiority.|||65.2|
73923013|NCT05778786|147375128|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.974|STANDARD_DEVIATION|0.01|||TWO_SIDED|95.0|0.95|0.989|||Bayesian beta- binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.989|0.950|
73923014|NCT05778786|147375129|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.989|STANDARD_DEVIATION|0.0054|||TWO_SIDED|95.0|0.976|0.997|||Bayesian beta-binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.997|0.976|
73923015|NCT05778786|147375130|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.989|STANDARD_DEVIATION|0.0053|||TWO_SIDED|95.0|0.977|0.997|||Bayesian beta- binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.997|0.977|
73923016|NCT05778786|147375131|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Central Posterior Proportion|0.003|STANDARD_DEVIATION|0.0028|||TWO_SIDED|95.0|0.0|0.01|||Bayesian beta-binomial model|Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.01 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible Interval.||0.010|0.000|
73923017|NCT05778786|147375132|SUPERIORITY|A superiority margin of 58 points was used.|Least-squares Mean|66.1|STANDARD_ERROR_OF_MEAN|2.48|||ONE_SIDED|95.0|61.2||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.|||61.2|
73923018|NCT05778786|147375133|SUPERIORITY|A superiority margin of 61 points was used.|Least-squares Mean|69.9|STANDARD_ERROR_OF_MEAN|1.66|||ONE_SIDED|95.0|66.6||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.|||66.6|
73923019|NCT03658538|147375145|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.025|TWO_SIDED|95.0|-8.2|-0.5||P-value corresponds to the statistical significance of the group difference (active vs. control) in the primary outcome, and was not adjusted for the multiple comparison and based on the a priori threshold for statistical significance (P\<0.05).|Generalized Linear Mixed Model (GLMM)|The analysis was adjusted for covariates.||||-0.5|-8.2|0.025
73923020|NCT03658538|147375146|SUPERIORITY|||||||0.061||||||P-value corresponds to the statistical significance of the group difference (active vs. control) in the primary outcome, and was not adjusted for the multiple comparison and based on the a priori threshold for statistical significance (P\<0.05).|Generalized Linear Mixed Model (GLMM)|The analysis was adjusted for covariates.||||||0.061
73923021|NCT02446990|147375155|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.08|STANDARD_ERROR_OF_MEAN|0.06||0.1969|TWO_SIDED|95.0|0.96|1.2|||Regression, Cox|||||1.2|0.96|0.1969
73923022|NCT02446990|147375156|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06|STANDARD_ERROR_OF_MEAN|0.07||0.3461|TWO_SIDED|95.0|0.94|1.21|||Regression, Cox|||||1.21|0.94|0.3461
73923023|NCT02446990|147375157|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.1|STANDARD_ERROR_OF_MEAN|0.09||0.2493|TWO_SIDED|95.0|0.94|1.28|||Regression, Cox|||||1.28|0.94|0.2493
73923024|NCT02446990|147375158|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06|STANDARD_ERROR_OF_MEAN|0.09||0.5162|TWO_SIDED|95.0|0.89|1.26|||Regression, Cox|||||1.26|0.89|0.5162
73923025|NCT02446990|147375159|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.35|STANDARD_ERROR_OF_MEAN|0.29||0.1647|TWO_SIDED|95.0|0.88|2.05|||Regression, Cox|||||2.05|0.88|0.1647
73923026|NCT02446990|147375160|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.04|STANDARD_ERROR_OF_MEAN|0.08||0.6024|TWO_SIDED|95.0|0.9|1.21|||Regression, Cox|||||1.21|0.90|0.6024
73923027|NCT02446990|147375161|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.89||||0.1458|TWO_SIDED|95.0|0.75|1.04|||Regression, Cox|||||1.04|0.75|0.1458
73923028|NCT02446990|147375162|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.0||||0.979|TWO_SIDED|95.0|0.89|1.12|||Regression, Cox|||||1.12|0.89|0.9790
73923029|NCT02446990|147375163|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.4299|TWO_SIDED|95.0|0.92|1.22|||Regression, Cox|||||1.22|0.92|0.4299
73923030|NCT02446990|147375164|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.97||||0.5916|TWO_SIDED|95.0|0.88|1.08|||Regression, Cox|||||1.08|0.88|0.5916
73923031|NCT02446990|147375165|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.98||||0.6963|TWO_SIDED|95.0|0.89|1.08|||Regression, Cox|||||1.08|0.89|0.6963
73923032|NCT02446990|147375166|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.2222|TWO_SIDED|95.0|0.96|1.18|||Regression, Cox|||||1.18|0.96|0.2222
73923033|NCT02446990|147375167|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.3671|TWO_SIDED|95.0|0.94|1.18|||Regression, Cox|||||1.18|0.94|0.3671
73923034|NCT02446990|147375168|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.97||||0.5285|TWO_SIDED|95.0|0.87|1.07|||Regression, Cox|||||1.07|0.87|0.5285
73923035|NCT01064401|147375169|SUPERIORITY_OR_OTHER||Rate Ratio|0.55|||<|0.0001|TWO_SIDED|95.0|0.469|0.645||Estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline EDSS (≤ 2.5 vs \> 2.5) and baseline age (≤ 35 vs \> 35 years).|Negative Binomial Regression|||||0.645|0.469|< 0.0001
73967849|NCT05592418|147473383|SUPERIORITY||Mean Difference (Final Values)|23.7749||||0.3162|TWO_SIDED|95.0|-23.2463|70.7962|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||70.7962|-23.2463|0.3162
73967850|NCT05592418|147473384|SUPERIORITY|||||||||||||||||P-value is from The Cochran-Mantel-Haenszel test (CMH) stratified by stratification factors|Since all patients analyzed achieved MCID, there are no comparison results|||
73967851|NCT05592418|147473385|SUPERIORITY||Mean Difference (Final Values)|-3.2342||||0.4232|TWO_SIDED|95.0|-11.2586|4.7901|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||4.7901|-11.2586|0.4232
73967852|NCT05592418|147473386|SUPERIORITY||Mean Difference (Final Values)|-0.5161||||0.7823|TWO_SIDED|95.0|-4.2356|3.2035|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||3.2035|-4.2356|0.7823
73967853|NCT05592418|147473388|SUPERIORITY||Mean Difference (Final Values)|0.2779||||0.5185|TWO_SIDED|95.0|-0.5775|1.1333|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo.|||1.1333|-0.5775|0.5185
73967854|NCT05592418|147473389|OTHER||||||||||||||||||No patients were hospitalized.|||
74028449|NCT04192448|147610590|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-1.0||||0.39|TWO_SIDED|95.0|-33.01|35.01|||t-test, 1 sided|This t-test examined the difference in sexual aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Anger condition and those in the Control condition. A negative value indicates greater likelihood of sexual aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||35.01|-33.01|.39
73967855|NCT05592418|147473391|SUPERIORITY||Mean Difference (Final Values)|169.389||||0.2175|TWO_SIDED|95.0|-105.892|444.6702|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo.|444.6702|-105.892|0.2175
74028450|NCT04192448|147610591|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|0.25||||0.33|TWO_SIDED|95.0|-2.88|2.63|||t-test, 1 sided|This t-test examined the difference in physical aggression intentions between those in the Alcohol Condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of physical aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||2.63|-2.88|.33
74028451|NCT04192448|147610591|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-0.25||||0.33|TWO_SIDED|95.0|-2.53|2.88|||t-test, 1 sided|The t-test examined the difference in physical aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Anger condition and those in the Control condition. A negative value indicates greater likelihood of physical aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||2.88|-2.53|.33
74086923|NCT02148445|147727841|SUPERIORITY|||||||0.42|||||||t-test, 1 sided|||||||0.42
74086924|NCT02148445|147727842|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
74086925|NCT02148445|147727843|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
73861763|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|560.46|||||TWO_SIDED|95.0|474.05|662.63||||||Serotype 22F: OPA GMT Ratio||662.63|474.05|
73861764|NCT04384107|147269296|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|196.14|||||TWO_SIDED|95.0|141.85|271.21||||||Serotype 33F: OPA GMT Ratio||271.21|141.85|
73967856|NCT05592418|147473392|SUPERIORITY||Mean Difference (Final Values)|-56.9984||||0.2086|TWO_SIDED|95.0|-147.021|33.0241|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|33.0241|-147.021|0.2086
73967857|NCT05592418|147473393|SUPERIORITY||Mean Difference (Final Values)|0.1733||||0.0975|TWO_SIDED|95.0|-0.0327|0.3792|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|0.3792|-0.0327|0.0975
73967858|NCT05592418|147473395|SUPERIORITY||Mean Difference (Final Values)|20.7131||||0.4545|TWO_SIDED|95.0|-34.4079|75.8341|||ANCOVA||LS Mean Difference - LS Mean of Ampligen® - LS Mean of Placebo|||75.8341|-34.4079|0.4545
73967859|NCT05592418|147473396|SUPERIORITY||Mean Difference (Final Values)|44.1231||||0.0333|TWO_SIDED|95.0|4.6338|83.6123|||ANCOVA||LS Mean Difference - LS Mean of Ampligen® - LS Mean of Placebo|||83.6123|4.6338|0.0333
74086926|NCT02148445|147727845|SUPERIORITY|||||||0.08|||||||Chi-squared|||Month 3 self-reported abstinence||||0.08
74086927|NCT02148445|147727845|SUPERIORITY|||||||0.06|||||||Chi-squared|||Month 3 biochemically verified abstinence||||0.06
74086928|NCT02148445|147727845|SUPERIORITY|||||||0.22|||||||Chi-squared|||Month 6, self-reported abstinence||||0.22
73923036|NCT01064401|147375169|SUPERIORITY_OR_OTHER||Percent Reduction|45.0|||||TWO_SIDED|95.0|35.5|53.1||||||||53.1|35.5|
73923037|NCT01064401|147375170|SUPERIORITY_OR_OTHER||Percent Reduction|54.4|||<|0.0001|TWO_SIDED|95.0|46.9|60.8||Estimated from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs \> 35 years).|Negative Binomial Regression|The logarithmic transformation of the scan number of the MRI assessment was included in the model as the 'offset' parameter.||||60.8|46.9|< 0.0001
73923038|NCT01064401|147375171|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.1575|TWO_SIDED|95.0|0.66|1.07||Based on Cox Proportional Hazards model, adjusted by baseline EDSS values as continuous variable, history of prior IFN beta use, and baseline age (≤ 35 vs \> 35 years).|Cox Proportional Hazard|||||1.07|0.66|0.1575
73923039|NCT01064401|147375171|SUPERIORITY_OR_OTHER||Percent Reduction|16.1|||||TWO_SIDED|95.0|-7.0|34.2||||||||34.2|-7.0|
73923040|NCT01064401|147375172|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.59|||<|0.0001|TWO_SIDED|95.0|0.5|0.69||Based on Cox proportional hazards model, adjusted for baseline relapse rate, history of prior IFN beta use, baseline EDSS (EDSS ≤ 2.5 vs EDSS \> 2.5) and baseline age (≤ 35 vs \> 35 years).|Cox Proportional Hazard|||||0.69|0.50|< 0.0001
73923041|NCT01064401|147375172|SUPERIORITY_OR_OTHER||Percent Reduction in Risk of Relapse|40.9|||||TWO_SIDED|95.0|30.8|49.5||||||||49.5|30.8|
73923042|NCT01064401|147375173|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.0176|TWO_SIDED|95.0|0.6|0.95||Based on logistic regression model, adjusted for baseline MSIS-29 physical score, baseline Beck Depression Inventory (BDI) score, history of prior IFN beta use, and baseline age (≤ 35 vs \> 35 years).|Regression, Logistic|||||0.95|0.60|0.0176
73923043|NCT01064401|147375173|SUPERIORITY_OR_OTHER||Percent Reduction in Odds of Worsening|24.2|||||TWO_SIDED|95.0|4.7|39.6||||||||39.6|4.7|
73923044|NCT02738151|147375213|NON_INFERIORITY|Non-inferiority of Toujeo vs Tresiba was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<0.3%.|Least Square (LS) Mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.152|0.051||Threshold for significance at 0.025 level.|Mixed Models Analysis||Toujeo vs. Tresiba|A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit, and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates.||0.051|-0.152|<.0001
73967860|NCT03001414|147473397|SUPERIORITY||Mean Difference (Final Values)|13.7|STANDARD_ERROR_OF_MEAN|16.69||0.42|TWO_SIDED|95.0|-20.08|47.48|||ANOVA|Global test of difference between the arms analyzed as absolute change from baseline.||Due to sample size restriction, the primary analysis plan was modified to analyze change from baseline to each time point using repeated measures of ANOVA.||47.48|-20.08|0.42
73967861|NCT03001414|147473397|SUPERIORITY||Mean Difference (Final Values)|13.7||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Calculation of raw change from baseline in meters using non-parametric Wilcoxon test.||||0.57
73967862|NCT03001414|147473397|SUPERIORITY||Mean Difference (Final Values)|4.55||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Secondary analysis of primary outcome using non-parametric Wilcoxon test of percent change from baseline.||||||0.53
73967863|NCT03001414|147473398|SUPERIORITY|Change from baseline calculated in meters using non-parametric analysis.|Mean Difference (Final Values)|41.97||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of these arms is in accordance with the statistical analysis plan.||||0.10
73967864|NCT03001414|147473399|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The selected arm for this outcome measure is in accordance with the statistical analysis plan.||||0.50
73967865|NCT03001414|147473400|SUPERIORITY||Mean Difference (Final Values)|22.92||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Comparison of change from baseline in meters at 6 and 12 months.||Selection of the arm for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.88
73967866|NCT03001414|147473401|SUPERIORITY||Mean Difference (Final Values)|0.132||||0.81|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.81
73967867|NCT03001414|147473402|SUPERIORITY||Median Difference (Final Values)|2.06||||0.63|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.63
73967868|NCT03001414|147473403|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.25
73967869|NCT03001414|147473404|SUPERIORITY||Mean Difference (Final Values)|5.6||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|This analysis represents the results for the Physical Component score of the questionnaire.||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||1.0
73967870|NCT03001414|147473404|SUPERIORITY||Median Difference (Final Values)|0.1||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This analysis represents the difference in score for the mental component of the questionnaire.|Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.64
73967871|NCT03001414|147473405|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.4|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This analysis represents the difference in score for the physical component of the questionnaire.|Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.40
73923045|NCT02738151|147375213|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.052||0.3302|TWO_SIDED|95.0|-0.152|0.051|||Mixed Models Analysis|||Superiority of Toujeo over Tresiba was demonstrated if the upper bound of the two-sided 95% CI for the difference in the mean change in HbA1c from baseline to Week 24 between Toujeo over Tresiba on ITT population was \<0 (zero).||0.051|-0.152|0.3302
73923046|NCT01975909|147375234|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of SARA (i.e., greater percent decrease of SARA score from baseline) as compared to the sham TMS.||||||0.29|||||||t-test, 2 sided|||||||0.29
73923047|NCT01975909|147375235|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 25-foot walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.47|||||||t-test, 2 sided|||||||0.47
73923048|NCT01975909|147375236|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 9-hole peg test (i.e., greater percent decrease of time to complete the test from baseline) as compared to the sham TMS.||||||0.12|||||||t-test, 2 sided|||||||0.12
73923049|NCT01975909|147375237|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 90-second walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.69|||||||t-test, 2 sided|||||||0.69
73923050|NCT01975909|147375238|EQUIVALENCE|We hypothesized that the real TMS would improve the standing postural control stability (i.e., greater percent decrease increase of postural sway speed from baseline) as compared to the sham TMS.||||||0.009|||||||t-test, 2 sided|||||||0.009
73923051|NCT01975909|147375239|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of TUG test (i.e., greater percent decrease of time to complete TUG test from baseline) as compared to the sham TMS.||||||0.18|||||||t-test, 2 sided|||||||0.18
73923052|NCT03649711|147375244|OTHER|Post treatment values were compared using ANCOVA||||||0.002|||||||ANCOVA|||||||0.002
73923053|NCT03649711|147375244|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||mean changes in values were compared by Wilcoxon rank sum test adjusted for multiple comparisons (Bonferonni method) between CKD-ticagrelor arm, and the non-CKD controls||||0.18
73923054|NCT03649711|147375245|OTHER|||||||0.22|||||||ANCOVA|||CKD groups randomized were compared for post treatment values.||||0.22
73923055|NCT05478252|147375249|NON_INFERIORITY|Non-inferiority of insulin semaglutide J versus insulin semaglutide B was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 2.5%. Non-inferiority was investigated on the FAS.|Treatment difference|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.3|0.08|||ANCOVA|||||0.08|-0.30|<.0001
73923056|NCT00858442|147375263|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks = 0.953, P\> 0.449 in group without PRP and in PRP group shapiro Wilks=0.946, P \> 0.259.~The data were normally distributed, with equal variances (Test of levene: F = 0.1234, P\> 0.99)"|Mean Difference (Final Values)|-2.452|STANDARD_ERROR_OF_MEAN|2.452|>|0.1574|TWO_SIDED|95.0|-7.332|2.428||Applies t-test for equality of means. t = -1.016 is obtained. p\> 0.1574|t-test, 1 sided|||||2.428|-7.332|>0.1574
73923057|NCT00858442|147375264|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks =0.972, P\> 0.687 in group without PRP and in PRP group shapiro Wilks = 0.964, P \> 0.410.~The data were normally distributed, with equal variances (Test of levene: F = 3.153, P\> 0.082)"|Mean Difference (Final Values)|-0.27186|STANDARD_ERROR_OF_MEAN|0.50519|>|0.593|TWO_SIDED|95.0|-1.28561|0.74189||Applies t-test for equality of means. t = -0.538 is obtained. p\> 0.593|t-test, 2 sided|||||0.74189|-1.28561|>0.593
73923058|NCT00858442|147375265|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks=0.822, P\<0.001 in group without PRP, and in PRP group shapiro Wilks =0.910, P\<0.017.~The data were no normally distributed, with equal variances (Test of levene, F=1.324, P\>0.255)"|||||>|0.398|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mean rank group without PRP= 28.88 Mean rank group with PRP= 26.31 Z value = -0.027||||||>0.398
73923059|NCT03329690|147375278|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|CMH test with region as a stratification factor||||||<0.0001
73923060|NCT02337907|147375296|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.073||0.7907|TWO_SIDED|95.0|-0.163|0.124||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.124|-0.163|0.7907
73923061|NCT02337907|147375296|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.075||0.7622|TWO_SIDED|95.0|-0.125|0.171||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.171|-0.125|0.7622
73931054|NCT05569954|147391864|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|35.9|||<|0.001||95.0|29.6|41.8||1-sided|Stratified Miettinen & Nurminen method||V16 minus PPSV23|Serotype 23A: V116-PPSV23 Percentage Difference||41.8|29.6|<0.001
73931055|NCT05569954|147391864|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|42.4|||<|0.001|TWO_SIDED|95.0|37.6|47.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 23B: V116-PPSV23 Percentage Difference||47.0|37.6|<0.001
73931056|NCT05569954|147391864|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|35.9|||<|0.001||95.0|30.6|41.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 24F: V116-PPSV23 Percentage Difference||41.0|30.6|<0.001
73931057|NCT05569954|147391864|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|56.2|||<|0.001|TWO_SIDED|95.0|51.5|60.5||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 31: V116-PPSV23 Percentage Difference||60.5|51.5|<0.001
73931058|NCT05569954|147391864|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|58.7|||<|0.001||95.0|54.6|62.7||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 35B: V116-PPSV23 Percentage Difference||62.7|54.6|<0.001
73923062|NCT02337907|147375296|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.071||0.8789|TWO_SIDED|95.0|-0.13|0.152||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.152|-0.130|0.8789
73923063|NCT02337907|147375296|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.074||0.0609|TWO_SIDED|95.0|-0.285|0.006||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.006|-0.285|0.0609
73923064|NCT02337907|147375296|SUPERIORITY|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.053||0.5687|TWO_SIDED|95.0|-0.135|0.074||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.074|-0.135|0.5687
73923065|NCT02337907|147375297|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.8694|TWO_SIDED|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.120|-0.101|0.8694
73967872|NCT03001414|147473405|SUPERIORITY||Mean Difference (Final Values)|15.4||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||This analysis represents the change in score for the mental component of the questionnaire.|||0.23
73967873|NCT03665597|147473414|OTHER|Geometric Least-Square Mean Ratio (GMR) = GM of Pembrolizumab 130 mg/mL SC/GM of Pembrolizumab 200 mg IV|GMR|0.73|||||TWO_SIDED|90.0|0.68|0.78||||||||0.78|0.68|
73967874|NCT03665597|147473414|OTHER|GMR = GM of Pembrolizumab 165 mg/mL SC/GM of Pembrolizumab 200 mg IV|GMR|0.69|||||TWO_SIDED|90.0|0.64|0.74||||||||0.74|0.64|
73967875|NCT03665597|147473415|OTHER|GMR = GM of Pembrolizumab 130 mg/mL SC/GM of Pembrolizumab 200 mg IV|Geometric Least-Square Mean Ratio|0.4|||||TWO_SIDED|90.0|0.36|0.44||||||||0.44|0.36|
73967876|NCT03665597|147473415|OTHER|GMR = GM of Pembrolizumab 165 mg/mL SC/GM of Pembrolizumab 200 mg IV|Geometric Least-Square Mean Ratio|0.38|||||TWO_SIDED|90.0|0.34|0.41||||||||0.41|0.34|
74028452|NCT04192448|147610592|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|0.67||||0.23|TWO_SIDED|95.0|-8.0|6.67|||t-test, 1 sided|The t-test examined differences in psychological aggression intentions between those in the Alcohol condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of psych aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||6.67|-8.00|.23
74028453|NCT04192448|147610592|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-0.17||||0.44|TWO_SIDED|95.0|-10.84|11.17|||t-test, 1 sided|The t-test examined the difference in psychological aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A negative value indicates greater likelihood of psych aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||11.17|-10.84|.44
74028454|NCT00128206|147610599|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.51|||>|0.05||95.0|0.13|2.01|||Chi-squared|||The null hypothesis was that there would be no difference in toxicity by study group, and a sample of 360 participants (180 in each group)was estimated to have sufficient power to detect a difference.||2.01|.13|>.05
74028455|NCT03270085|147610602|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74028456|NCT03270085|147610603|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
74028457|NCT03270085|147610604|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
74086929|NCT02148445|147727845|SUPERIORITY|||||||0.34|||||||Chi-squared|||Month 6, biochemically verified abstinence||||0.34
73923066|NCT02337907|147375297|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.057||0.9512|TWO_SIDED|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.109|-0.116|0.9512
73923067|NCT02337907|147375297|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.056||0.9321|TWO_SIDED|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.115|-0.105|0.9321
73923068|NCT02337907|147375297|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.057||0.1288|TWO_SIDED|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.025|-0.199|0.1288
73923069|NCT02337907|147375297|SUPERIORITY|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.041||0.6492|TWO_SIDED|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.061|-0.098|0.6492
73923070|NCT02337907|147375298|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|1.066||0.5287|TWO_SIDED|95.0|-1.43|2.77||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||2.77|-1.43|0.5287
73923071|NCT02337907|147375298|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.099||0.7105|TWO_SIDED|95.0|-2.57|1.76||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.76|-2.57|0.7105
73967877|NCT04831216|147473437|OTHER|||||||0.0107||||||The p-value reflects results of analysis of change in HbA1c from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0107
73967878|NCT04831216|147473438|OTHER|||||||0.7927||||||The p-value reflects results of analysis of change in skin carotenoid levels from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.7927
73967879|NCT04831216|147473439|OTHER|||||||0.4651||||||The p-value reflects results of analysis of change in HEI score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.4651
73967880|NCT04831216|147473440|OTHER|||||||0.2439||||||The p-value reflects results of analysis of change in BMI from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.2439
73967881|NCT04831216|147473442|OTHER|||||||0.6794||||||The p-value reflects results of analysis of change in DMSES scale score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.6794
74086930|NCT02148445|147727845|SUPERIORITY|||||||0.66|||||||Chi-squared|||Month 12, self-reported abstinence||||0.66
74086931|NCT02148445|147727846|SUPERIORITY|||||||0.0149|||||||Mixed Models Analysis|||||||0.0149
74086932|NCT02148445|147727847|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73861765|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.53|||||TWO_SIDED|95.0|0.38|0.75||||||Serotype 1: OPA GMT Ratio||0.75|0.38|
74086933|NCT02148445|147727848|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
73923072|NCT02337907|147375298|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.064||0.3822|TWO_SIDED|95.0|-1.16|3.03||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.03|-1.16|0.3822
73923073|NCT02337907|147375298|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.066||0.6472|TWO_SIDED|95.0|-2.59|1.61||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.61|-2.59|0.6472
73923074|NCT02337907|147375299|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7551|TWO_SIDED|95.0|-0.46|0.64||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.64|-0.46|0.7551
73923075|NCT02337907|147375299|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.28||0.3643|TWO_SIDED|95.0|-0.29|0.8||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.80|-0.29|0.3643
73923076|NCT02337907|147375299|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7822|TWO_SIDED|95.0|-0.45|0.6||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.60|-0.45|0.7822
73923077|NCT02337907|147375299|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.6889|TWO_SIDED|95.0|-0.43|0.65||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.65|-0.43|0.6889
73923078|NCT02337907|147375300|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.933||0.1595|TWO_SIDED|95.0|-0.52|3.15||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.15|-0.52|0.1595
73923079|NCT02337907|147375300|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.962||0.2455|TWO_SIDED|95.0|-0.77|3.01||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.01|-0.77|0.2455
73931059|NCT05569954|147391865|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4 fold rise from baseline to 30 days postvaccination being \>50 percentage points (1-sided p-value \<0.025)."||||||0.093||||||1-sided|Clopper-Pearson method|||Serotype 6C||||0.093
73931060|NCT05569954|147391865|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4 fold rise from baseline to 30 days postvaccination being \>50 percentage points (1-sided p-value \<0.025)."|||||<|0.001||||||1-sided|Clopper-Pearson method|||Serotype 15B||||<0.001
73931061|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|1.04|1.25|||||V116/PPSV23|Serotype 3: V116/PPSV23 GMC Ratio||1.25|1.04|
73931062|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.86|||||TWO_SIDED|95.0|1.65|2.1|||||V116/PPSV23|Serotype 7F: V116/PPSV23 GMC Ratio||2.10|1.65|
73931063|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.17|||||TWO_SIDED|95.0|1.04|1.31|||||V116/PPSV23|Serotype 8: V116/PPSV23 GMC Ratio||1.31|1.04|
73931064|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.55|||||TWO_SIDED|95.0|1.37|1.76|||||V116/PPSV23|Serotype 9N: V116/PPSV23 GMC Ratio||1.76|1.37|
74086934|NCT02148445|147727849|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
73861766|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.28|2.03||||||Serotype 3: OPA GMT Ratio||2.03|1.28|
73931065|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.03|||||TWO_SIDED|95.0|1.79|2.31|||||V116/PPSV23|Serotype 10A: V116/PPSV23 GMC Ratio||2.31|1.79|
73923080|NCT02337907|147375300|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|0.94||0.1732|TWO_SIDED|95.0|-0.57|3.13||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.13|-0.57|0.1732
73923081|NCT02337907|147375300|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|2.47|STANDARD_ERROR_OF_MEAN|0.936||0.0088|TWO_SIDED|95.0|0.63|4.31||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||4.31|0.63|0.0088
73931066|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.2|||||TWO_SIDED|95.0|1.97|2.46|||||V116/PPSV23|Serotype 11A: V116/PPSV23 GMC Ratio||2.46|1.97|
74028458|NCT02340104|147610605|EQUIVALENCE|Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as model with treatment as a fixed effect and participant and error as random effects.|Ratio of Geometric LS Means|0.789|||||TWO_SIDED|90.0|0.769|0.81|||||Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as independent variables, where participant was fitted as a random effect.|||0.810|0.769|
74028459|NCT01269125|147610606|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|STANDARD_ERROR_OF_MEAN|0.0||0.8|TWO_SIDED|95.0|-0.2|0.3|||Chi-squared|||||0.3|-0.2|0.80
74028460|NCT01269125|147610610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.05|STANDARD_ERROR_OF_MEAN|0.0||0.8||95.0|-0.2|0.3|||Chi-squared|||||0.3|-0.2|0.80
74028461|NCT01269125|147610610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.48||95.0|-0.4|0.2|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||0.2|-0.4|0.48
74028462|NCT01269125|147610610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-0.15|STANDARD_ERROR_OF_MEAN|0.0||0.22||95.0|-0.4|0.1|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||0.1|-0.4|0.22
74028463|NCT01040832|147610611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.793|TWO_SIDED|95.0|0.7|1.6|||Stratified log rank|||||1.6|0.7|0.793
74028464|NCT01040832|147610612|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Cochran-Mantel-Haenszel|||||||>0.999
74086935|NCT02148445|147727850|SUPERIORITY|||||||0.0918|||||||Mixed Models Analysis|||||||0.0918
74086936|NCT03450629|147727851|EQUIVALENCE|8 AM +/- 30 min||||||0.0006|||||||t-test, 2 sided|||||||0.0006
74086937|NCT03450629|147727851|EQUIVALENCE|10 AM +/- 30 min||||||0.0291|||||||t-test, 2 sided|||||||0.0291
74028465|NCT01040832|147610613|SUPERIORITY_OR_OTHER|||||||0.557||95.0|||||Cochran-Mantel-Haenszel|||||||0.557
74028466|NCT00663858|147610635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.592|STANDARD_ERROR_OF_MEAN|0.662||0.371|TWO_SIDED|95.0|-1.894|0.709|||ANOVA|||||0.709|-1.894|0.371
74028467|NCT00663858|147610635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.711|STANDARD_ERROR_OF_MEAN|0.722||0.3253|TWO_SIDED|95.0|-709.0|2.132|||ANCOVA|||||2.132|-0709|0.3253
74028468|NCT00663858|147610635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.324|STANDARD_ERROR_OF_MEAN|0.62||0.0333|TWO_SIDED|95.0|-2.542|-0.106|||ANCOVA|||||-0.106|-2.542|0.0333
74028469|NCT02940886|147610636|NON_INFERIORITY|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.13|0.13|||||Mixed Model for Repeated Measurement was used for testing and included the fixed categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."||0.13|-0.13|
74028470|NCT02940886|147610637|OTHER||95% two-sided CI (iron isomaltoside)|0.3|||||TWO_SIDED|95.0|0.06|0.88||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."||0.88|0.06|
74086938|NCT03450629|147727851|EQUIVALENCE|4 PM +/- 30 min||||||0.0002|||||||t-test, 2 sided|||||||0.0002
74086939|NCT04230876|147727852|SUPERIORITY||partial eta squared|0.047|||=|0.269|TWO_SIDED|||||Within the 28 participants, changes in the COSI scores after four weeks using the Amptify were compared to the changes after four weeks watching 20 minutes of CC TV (F(1,26)=1.28).|ANOVA|||||||=0.269
74086940|NCT04230876|147727853|SUPERIORITY||partial eta squared|0.031|||=|0.401|TWO_SIDED|||||Changes in the IOI-HA scores measured after four weeks using the Amptify were compared to the changes seen after four weeks of CC TV every day (F(1,23)=.733).|ANOVA|||||||=0.401
74086941|NCT04230876|147727854|SUPERIORITY||partial eta squared|0.0|||=|0.968|TWO_SIDED|||||Changes in the APHAB benefit scores after four weeks using the Amptify were compared to the improvements seen after four weeks of CC TV every day (F(1,25)=.002).|ANOVA|||||||=0.968
74086942|NCT04230876|147727855|SUPERIORITY||partial eta squared|0.028|||=|0.392|TWO_SIDED|||||Changes in the SSQ-12 scores after four weeks using the Amptify were compared to the improvements seen after four weeks watching 20 minutes of CC TV (F(1,26)=.756).|ANOVA|||||||=0.392
73923082|NCT02876900|147375301|SUPERIORITY|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.634||0.003|TWO_SIDED|95.0|-8.06|-1.64||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-1.64|-8.06|0.003
73923083|NCT02876900|147375301|SUPERIORITY|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-9.81|-3.4||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-3.4|-9.81|<0.001
73923084|NCT02876900|147375302|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.16||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-0.16|-0.55|<0.001
73923085|NCT02876900|147375302|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.64|-0.25||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-0.25|-0.64|<0.001
73923086|NCT04327388|147375354|SUPERIORITY||Hazard Ratio (HR)|1.026||||0.9561|TWO_SIDED|95.0|0.751|1.402|||Log-rank test|Analyzed based on logrank test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|Hazard ratio for estimation of treatment effect of each sarilumab dose versus placebo was assessed by cox proportional hazard model stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|||1.402|0.751|0.9561
73923087|NCT04327388|147375354|SUPERIORITY||Hazard Ratio (HR)|1.135||||0.3376|TWO_SIDED|95.0|0.835|1.543|||Log-rank test|Analyzed based on logrank test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|Hazard ratio for estimation of treatment effect of each sarilumab dose versus placebo was assessed by cox proportional hazard model stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|||1.543|0.835|0.3376
73967882|NCT04831216|147473443|OTHER|||||||0.1043||||||The p-value reflects results of analysis of change in oral health behavior from baseline to post-intervention.|Mixed Models Analysis|Cumulative logit mixed effects model included time, age, household size, gender, race, education, and employment.||Cumulative logit mixed effects model (using PROC GLIMMIX) for repeated measures used all available participant data. This model is specifically designed for ordinal outcomes. Analyses do not include imputed missing values.||||0.1043
73967883|NCT04831216|147473444|OTHER||||||<|0.0001||||||The p-value reflects results of analysis of change in PAID-5 scale score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||<0.0001
73967884|NCT04831216|147473446|OTHER|||||||0.5332||||||The p-value reflects results of analysis of change in number of visits to food pantries in the past 30 days from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.5332
73967885|NCT04831216|147473447|OTHER|||||||0.0468||||||The p-value reflects results of analysis of change in ARMS-D scale scores from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0468
73967886|NCT04831216|147473450|OTHER||||||<|0.0001||||||The p-value reflects results of analysis of change in days per week following general healthful diet from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||<0.0001
74028471|NCT02940886|147610637|OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.91|0.71||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.71|-0.91|
73923088|NCT04327388|147375355|SUPERIORITY||Difference in percentage|-1.7||||0.628|TWO_SIDED|95.0|-9.27|5.81|||Cochran-Mantel-Haenszel|By Cochran-Mantel-Haenszel test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.||||5.81|-9.27|0.6280
73923089|NCT04327388|147375355|SUPERIORITY||Difference in percentage|0.2||||0.8478|TWO_SIDED|95.0|-6.93|7.41|||Cochran-Mantel-Haenszel|By Cochran-Mantel-Haenszel test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.||||7.41|-6.93|0.8478
73923090|NCT03559257|147375390|SUPERIORITY||LSMean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.92|-2.32|||Mixed Models Analysis|||||-2.32|-3.92|<0.0001
73923091|NCT03559257|147375391|SUPERIORITY||LSMean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.41|-1.72|||Mixed Models Analysis|||||-1.72|-3.41|<0.0001
73923092|NCT03559257|147375392|SUPERIORITY||Odds Ratio (OR)|3.935|||<|0.0001|TWO_SIDED|95.0|2.719|5.693|||pseudo likelihood-based repeated measure|||||5.693|2.719|<0.0001
73923093|NCT03559257|147375393|SUPERIORITY||Odds Ratio (OR)|3.481|||<|0.0001|TWO_SIDED|95.0|2.252|5.381|||Pseudo likelihood-based repeated measure|||||5.381|2.252|<0.0001
73923094|NCT03559257|147375394|SUPERIORITY||LSMean Difference|12.53|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|9.19|15.87|||Mixed Models Analysis|||||15.87|9.19|<0.0001
73923095|NCT03559257|147375395|SUPERIORITY||LSMean Difference|11.51|STANDARD_ERROR_OF_MEAN|2.22|<|0.0001|TWO_SIDED|95.0|7.14|15.89|||Mixed Models Analysis|||||15.89|7.14|<0.0001
73923096|NCT03559257|147375396|SUPERIORITY||Odds Ratio (OR)|5.878||||0.0001|TWO_SIDED|95.0|2.374|14.554|||Pseudo likelihood-based repeated measure|||||14.554|2.374|0.0001
74028472|NCT02940886|147610637|NON_INFERIORITY|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.48|-0.57|
74028473|NCT02940886|147610638|SUPERIORITY|||||||0.5695|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher's exact test.||||0.5695
73923097|NCT03559257|147375397|SUPERIORITY||Odds Ratio (OR)|999.999|||<|0.0001|TWO_SIDED|95.0|548.706|999.999|||Pseudo likelihood-based repeated measure||Estimated value and upper bound are \>999.999|||999.999|548.706|<0.0001
73923098|NCT03559257|147375398|SUPERIORITY||Odds Ratio (OR)|5.012|||<|0.0001|TWO_SIDED|95.0|2.352|10.679|||pseudo likelihood-based repeated measure|||||10.679|2.352|<0.0001
73923099|NCT03559257|147375399|SUPERIORITY||Odds Ratio (OR)|999.99|||<|0.0001|TWO_SIDED|95.0|999.99|999.99|||Pseudo likelihood-based repeated measure||Point estimate, upper limit and lower limit are \>999.99|||999.99|999.99|<0.0001
73923100|NCT03559257|147375400|SUPERIORITY||LSMean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-4.14|-2.65|||Mixed Models Analysis|||||-2.65|-4.14|<0.0001
73923101|NCT03559257|147375401|SUPERIORITY||LSMean Difference|-3.13|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.96|-2.29|||Mixed Models Analysis|||||-2.29|-3.96|<0.0001
73923102|NCT03559257|147375402|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73923103|NCT03559257|147375403|SUPERIORITY||LSMean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-1.58|-0.54|||Mixed Models Analysis|||||-0.54|-1.58|<0.0001
73923104|NCT03559257|147375404|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Activity Impairment.||||<0.0001
73923105|NCT03559257|147375404|SUPERIORITY|||||||0.388|||||||ANCOVA|||Absenteeism.||||0.3880
73923106|NCT03559257|147375404|SUPERIORITY|||||||0.0004|||||||ANCOVA|||Presenteeism.||||0.0004
73923107|NCT03559257|147375404|SUPERIORITY|||||||0.0003|||||||ANCOVA|||Work impairment.||||0.0003
73923108|NCT03559257|147375405|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
73923109|NCT03559257|147375406|SUPERIORITY|||||||0.1267|||||||ANCOVA|||||||0.1267
73923110|NCT03559257|147375407|SUPERIORITY|||||||0.163|||||||ANCOVA|||||||0.1630
73923111|NCT03559257|147375408|SUPERIORITY|||||||0.0277|||||||ANCOVA|||||||0.0277
73923112|NCT01519960|147375409|OTHER||Odds Ratio (OR)|5.43|||=|0.0043|TWO_SIDED|95.0|1.54|19.2|||Cochran-Mantel-Haenszel|||Analysis stratified by hepatitis B virus (HBV) genotype A versus non-A genotypes and alanine aminotransferase (ALT) less than (\<) 5 times (×) upper limit of normal (ULN) versus greater than or equal to (≥) 5 × ULN at Baseline. The OR was calculated using Group B as reference.||19.2|1.54|= 0.0043
73923113|NCT01519960|147375409|OTHER||||||=|0.3732|||||||Breslow-Day|||||||= 0.3732
73931067|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.99|||||TWO_SIDED|95.0|1.72|2.3|||||V116/PPSV23|Serotype 12F: V116/PPSV23 GMC Ratio||2.30|1.72|
73931068|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.39|||||TWO_SIDED|95.0|2.12|2.7|||||V116/PPSV23|Serotype 17F: V116/PPSV23 GMC Ratio||2.70|2.12|
73931069|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.49|||||TWO_SIDED|95.0|1.32|1.67||||||Serotype 19A: V116/PPSV23 GMC Ratio|V116/PPSV23|1.67|1.32|
73931070|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.86|||||TWO_SIDED|95.0|1.65|2.1|||||V116/PPSV23|Serotype 20A: V116/PPSV23 GMC Ratio||2.10|1.65|
73931071|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.77|||||TWO_SIDED|95.0|1.55|2.02|||||V116/PPSV23|Serotype 22F: V116/PPSV23 GMC Ratio||2.02|1.55|
73931072|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.22|||||TWO_SIDED|95.0|1.08|1.37|||||V116/PPSV23|Serotype 33F: V116/PPSV23 GMC Ratio||1.37|1.08|
73931073|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|3.78|||||TWO_SIDED|95.0|3.29|4.35|||||V116/PPSV23|Serotype 6A: V116/PPSV23 GMC Ratio||4.35|3.29|
73931074|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|8.92|||||TWO_SIDED|95.0|7.89|10.09|||||V116/PPSV23|Serotype 15A: V116/PPSV23 GMC Ratio||10.09|7.89|
73931075|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|3.43|||||TWO_SIDED|95.0|3.01|3.92|||||V116/PPSV23|Serotype 15C: V116/PPSV23 GMC Ratio||3.92|3.01|
74086943|NCT04230876|147727856|SUPERIORITY||partial eta squared|0.005|||=|0.72|TWO_SIDED|||||Among the 28 participants, changes in the hours per day of hearing aid usage seen after four weeks using the Amptify were compared to the changes seen after four weeks of CC TV every day (F(1,26)=.131).|ANOVA|||||||=0.720
74086944|NCT04230876|147727857|SUPERIORITY||partial eta squared|0.052|||=|0.242|TWO_SIDED|||||Changes in the NU-6 seen after four weeks using the Amptify were compared to the changes seen after four weeks watching 20 minutes of CC TV (F(1,26)=1.43).|ANOVA|||||||=0.242
74086945|NCT00739973|147727877|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-9.97|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-12.81|-7.12|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-7.12|-12.81|<0.001
73923114|NCT01387347|147375482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.2596|||||||t-test, 2 sided|||Inferior corneal fluorescein staining score at Day 29(primary sign) was summarized using descriptive statistics (number of observations, mean, standard deviation, median, minimum, and maximum). Active treatment was compared to placebo using a two-sample t-test assuming unequal variances, assessed at the α = 0.05 level||||0.2596
73923115|NCT01387347|147375482|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||t-test, 2 sided|||Comparison of central corneal fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0075
73923116|NCT01387347|147375482|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||t-test, 2 sided|||Comparison of superior corneal fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0210
73923117|NCT01387347|147375483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.3734|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups uses a two-sample t-test assuming unequal variances, assessed at the alpha = 0.05 level.||||0.3734
73923118|NCT01387347|147375483|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED||||||t-test, 2 sided|||Comparison of discomfort score between the placebo and Thymosin beta 4 groups on Day 28||||0.0244
73923119|NCT00561080|147375488|NON_INFERIORITY_OR_EQUIVALENCE|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|Geometric Mean Titer Ratio (GMTR)|1.11||||0.948|TWO_SIDED|95.0|1.02|1.22|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1|||1.22|1.02|0.948
73967887|NCT04831216|147473451|OTHER|||||||0.0649||||||The p-value reflects results of analysis of change in days per week following specific diet recommendations from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0649
73967888|NCT04831216|147473452|OTHER|||||||0.0049||||||The p-value reflects results of analysis of change in days per week engaging in exercise from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0049
73967889|NCT04831216|147473453|OTHER|||||||0.0086||||||The p-value reflects results of analysis of change in days per week conducted blood glucose testing from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0086
74086946|NCT00739973|147727878|SUPERIORITY_OR_OTHER||Least Square mean Difference|-4.82|STANDARD_ERROR_OF_MEAN|1.47||0.001|TWO_SIDED|95.0|-7.7|-1.94|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-1.94|-7.70|0.001
73861767|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.93||||||Serotype 4: OPA GMT Ratio||0.93|0.57|
73923120|NCT00561080|147375488|NON_INFERIORITY_OR_EQUIVALENCE|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|GMTR|0.78|||>|0.999|TWO_SIDED|95.0|0.73|0.85|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1|||0.85|0.73|>0.999
73923121|NCT00561080|147375489|SUPERIORITY_OR_OTHER||GMFR|2.35|||||TWO_SIDED|95.0|2.11|2.62|||||GMFR=GMT Post Dose/GMT Pre Dose|||2.62|2.11|
73923122|NCT00561080|147375491|SUPERIORITY_OR_OTHER||GMT Ratio|1.06|||||TWO_SIDED|95.0|0.96|1.17|||||GMT Ratio = Group 2 GMT/Group 1 GMT|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model||1.17|0.96|
73923123|NCT00561080|147375491|SUPERIORITY_OR_OTHER||GMT Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.19|||||GMT Ratio = GMT Group 3/GMT Group 1|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model||1.19|0.98|
73923124|NCT03194555|147375521|SUPERIORITY||Risk Difference (RD)|-2.17||||0.4267|TWO_SIDED|95.0|-3.67|8.01|||Chi-squared|||||8.01|-3.67|0.4267
73923125|NCT03194555|147375522|SUPERIORITY||Risk Difference (RD)|2.0||||0.268|TWO_SIDED|95.0|-18.46|66.83|||Chi-squared|||||66.83|-18.46|0.268
74028474|NCT02940886|147610639|SUPERIORITY|||||||0.3913|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.||||0.3913
74028475|NCT02940886|147610641|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0077|TWO_SIDED|95.0|1.27|4.72|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥2 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||4.72|1.27|0.0077
74028476|NCT02940886|147610641|SUPERIORITY||Odds Ratio (OR)|2.42|||<|0.0001|TWO_SIDED|95.0|1.8|3.26|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥2 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||3.26|1.80|<0.0001
73861768|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.13||||||Serotype 5: OPA GMT Ratio||1.13|0.66|
73861769|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.91||||||Serotype 6A: OPA GMT Ratio||0.91|0.57|
73861770|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.66|||||TWO_SIDED|95.0|0.52|0.83||||||Serotype 6B: OPA GMT Ratio||0.83|0.52|
73861771|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.68|1.07||||||Serotype 7F: OPA GMT Ratio||1.07|0.68|
73861772|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.65|||||TWO_SIDED|95.0|0.5|0.84||||||Serotype 9V: OPA GMT Ratio||0.84|0.50|
73861773|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.48|||||TWO_SIDED|95.0|1.16|1.9||||||Serotype 14: OPA GMT Ratio||1.90|1.16|
73861774|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.95|1.48||||||Serotype 18C: OPA GMT Ratio||1.48|0.95|
73861775|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.6|1.01||||||Serotype 19A: OPA GMT Ratio||1.01|0.60|
73861776|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.23|||||TWO_SIDED|95.0|1.0|1.52||||||Serotype 19F: OPA GMT Ratio||1.52|1.00|
73861777|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.37|||||TWO_SIDED|95.0|0.28|0.49||||||Serotype 23F: OPA GMT Ratio||0.49|0.28|
73861778|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|155.88|||||TWO_SIDED|95.0|101.84|238.59||||||Serotype 22F: OPA GMT Ratio||238.59|101.84|
73861779|NCT04384107|147269297|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|16.81|||||TWO_SIDED|95.0|11.74|24.08||||||Serotype 33F: OPA GMT Ratio||24.08|11.74|
73861780|NCT00316524|147269309|NON_INFERIORITY|The non-inferiority margin to show that Group 4 (vaccinia experienced subjects receiving a single vaccination) is non-inferior to Group 1 (vaccinia naive subjects receiving 2 vaccinations) in terms of seroconversion rate 2 weeks after the last vaccination was predefined as -5% for the difference in seroconversion rates|Difference in seroconversion rates (%)|-3.4|||||ONE_SIDED|97.5|-7.36||||||||||-7.36|
74028477|NCT02940886|147610641|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1049|TWO_SIDED|95.0|0.96|1.58|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥2 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.58|0.96|0.1049
73861781|NCT01800318|147269327|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||RM Anova of effects of treatment groups on PIPP scores: .|ANOVA|||||||0.07
73861782|NCT01800318|147269327|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and sham NESAP.||||<0.05
74028478|NCT02940886|147610641|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7032|TWO_SIDED|95.0|0.8|1.38|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥2 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.38|0.80|0.7032
73861783|NCT01800318|147269327|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with NESAP and oral water.||||<0.01
73861784|NCT01800318|147269327|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and NESAp combined.||||<0.05
73861785|NCT01800318|147269327|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|Bonferroni||t test comparing baseline PIPP score with heel stick PIPP scores in standard care group (Sham NESAP with oral water).||||<0.01
73861786|NCT01800318|147269328|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.9
73861787|NCT01800318|147269329|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.9
73861788|NCT01800318|147269331|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANOVA|F4.048||||||0.008
73861789|NCT02937766|147269359|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.25||0.093|TWO_SIDED|95.0|-0.1|0.9|||t-test, 2 sided|The t-test tested the hypothesis of no treatment difference between treatment groups.||||0.9|-0.1|0.093
74028479|NCT02940886|147610642|SUPERIORITY|||||||0.088|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.||||0.0880
74028480|NCT02940886|147610643|SUPERIORITY||Odds Ratio (OR)|1.14||||0.242|TWO_SIDED|95.0|0.92|1.41|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of \>12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.||1.41|0.92|0.2420
73861790|NCT02937766|147269360|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.234|TWO_SIDED|95.0|-0.2|0.7||The t-test tested the hypothesis of no treatment difference between treatment groups.|t-test, 2 sided|||||0.7|-0.2|0.234
73923126|NCT03194555|147375523|SUPERIORITY||Risk Difference (RD)|3.0||||0.0926|TWO_SIDED|95.0|-17.2|67.4|||Chi-squared|||||67.4|-17.2|0.0926
73923127|NCT03194555|147375524|SUPERIORITY||Risk Difference (RD)|2.0||||0.2894|TWO_SIDED|95.0|-17.2|67.4|||Chi-squared|||||67.4|-17.2|0.2894
73861791|NCT00046930|147269365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0|||||Log Rank|Stratified on age (\< 70 vs. \>=70) and type of leukemia (de novo AML, secondary RAEB-t, or secondary RAEB AML)||The study was designed to have 80% power to detect a non-proportional hazards difference in OS at the one-sided 0.025 significance level of 30.2% vs 39.6%, 12.8% vs 27.1% and 7.0% vs 14.0% at 1 years, 2 years, and full information for zosuquidar and placebo, respectively.||||0.28
73861792|NCT00046930|147269366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16||95.0|||||Log Rank|Stratified on age and type of leukemia||||||0.16
73861793|NCT00046930|147269367|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.617|TWO_SIDED|95.0|0.77|1.65||Test was stratified on age and type of leukemia.|Mantel Haenszel||Zosuquidar/Placebo|Test of difference in the CR (complete remission) rate between the arms.||1.65|0.77|0.617
73861794|NCT01149486|147269397|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.45|||||TWO_SIDED|90.0|80.2|108.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.88|80.20|
73923128|NCT03194555|147375525|SUPERIORITY||Risk Difference (RD)|-1.83||||0.5724|TWO_SIDED|95.0|-5.1557|8.8157|||Chi-squared|||||8.8157|-5.1557|0.5724
73967890|NCT04831216|147473454|OTHER|||||||0.0243||||||The p-value reflects results of analysis of change in days per week conducting food checks from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0243
74028481|NCT02940886|147610644|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8746|TWO_SIDED|95.0|0.81|1.28|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."||1.28|0.81|0.8746
74086947|NCT00739973|147727879|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-13.85|STANDARD_ERROR_OF_MEAN|1.44|<|0.001|TWO_SIDED|95.0|-16.68|-11.0|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-11.0|-16.68|<0.001
74086948|NCT00739973|147727880|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-13.2|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-16.04|-10.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-10.4|-16.04|<0.001
73923129|NCT03194555|147375526|SUPERIORITY||Risk Difference (RD)|-9.84||||0.2998|TWO_SIDED|95.0|-11.15|30.83|||Chi-squared|||||30.83|-11.15|0.2998
73923130|NCT03194555|147375527|SUPERIORITY||Risk Difference (RD)|-11.67||||0.2673|TWO_SIDED||||||Chi-squared|||||||0.2673
73923131|NCT03194555|147375530|SUPERIORITY||Risk Difference (RD)|28.76||||0.3527|TWO_SIDED|95.0|-94.5005|36.9805|||Chi-squared|||||36.9805|-94.5005|0.3527
73923132|NCT03194555|147375531|SUPERIORITY||Risk Difference (RD)|-1.95||||0.5246|TWO_SIDED||||||Chi-squared|||||||0.5246
73923133|NCT03194555|147375533|SUPERIORITY||Risk Difference (RD)|0.34||||0.8649|TWO_SIDED||||||Chi-squared|||||||0.8649
73967891|NCT04831216|147473455|OTHER|||||||0.2861||||||The p-value reflects results of analysis of change in smoking status (yes/no) from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.2861
73967892|NCT04831216|147473456|OTHER|||||||0.9933||||||The p-value reflects results of analysis of change in days per week adhering to prescribed medications from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.9933
73967893|NCT01212029|147473565|OTHER|One sample t-tests of standardized regression coefficients of RMSSD predicting O2Hb during baseline||||||0.008||||||t-test was performed 16 times for 16 fNIRS channels. The reported p-value is an uncorrected value for channel 10.|t-test, 2 sided|||Null hypothesis: there is no significant correlation between RMSSD and O2Hb levels during baseline||||0.008
73967894|NCT01212029|147473566|OTHER|||||||0.0105|||||||Tukey method|||||||0.0105
73967895|NCT03336333|147473581|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.63||One-sided|Log Rank|||||0.63|0.28|<0.0001
73967896|NCT05481216|147473641|OTHER|Unadjusted and adjusted hazard ratios (HR) will be calculated using a proportional Cox regression model. The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.73|2.29||||||||2.29|0.73|
73967897|NCT05481216|147473641|OTHER||Adjusted Hazard Ratio|1.3|||||TWO_SIDED|95.0|0.73|2.29||||||The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.||2.29|0.73|
73967898|NCT05481216|147473645|OTHER|||||||0.009|||||||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19.||||0.009
73967899|NCT05481216|147473666|OTHER||Odds Ratio (OR)|0.85||||0.033|TWO_SIDED|95.0|0.74|0.99|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||0.99|0.74|0.033
73967900|NCT05481216|147473667|OTHER||Odds Ratio (OR)|1.93||||0.012|TWO_SIDED|95.0|1.16|3.22|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||3.22|1.16|0.012
74086949|NCT00739973|147727881|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.77|-4.22|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-4.22|-7.77|<0.001
73923134|NCT01831154|147375534|SUPERIORITY_OR_OTHER|||||||0.512|||||||Chi-squared|Chi-squared value of 1.34 and Cramer's V .190||Cross tabulation with statistical testing with chi-square and Cramer's V was performed on infection to determine if there was any difference in surgical site infections between the interventional groups in 30 day period.||||0.512
73923135|NCT01831154|147375535|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||||||0.024
73923136|NCT01831154|147375537|SUPERIORITY_OR_OTHER|||||||0.132|||||||ANOVA|||||||0.132
73923137|NCT01831154|147375538|SUPERIORITY_OR_OTHER|||||||0.908||||||A one way ANOVA was used to determine if participants in the tight glycemic group had shorter intensive care unit (ICU) length of stay (LOS) than participants in the other interventional groups.|ANOVA|||||||0.908
73923138|NCT02448654|147375554|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.18
73923139|NCT02448654|147375555|SUPERIORITY|||||||0.03||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.03
73923140|NCT02448654|147375556|SUPERIORITY|||||||0.037||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.037
73923141|NCT03255382|147375557|OTHER||Adjusted percentage difference|73.3|||<|0.001|TWO_SIDED|95.0|61.3|85.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (prior phototherapy \[yes/no\]).||85.3|61.3|< 0.001
73923142|NCT03255382|147375558|OTHER||Adjusted percentage difference|46.8|||<|0.001|TWO_SIDED|95.0|32.8|60.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||60.8|32.8|< 0.001
73923143|NCT03255382|147375559|OTHER||Adjusted percentage difference|63.4|||<|0.001|TWO_SIDED|95.0|50.2|76.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||76.6|50.2|< 0.001
73923144|NCT03255382|147375560|OTHER||Adjusted percentage difference|53.1|||<|0.001|TWO_SIDED|95.0|40.4|65.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||65.7|40.4|< 0.001
74086950|NCT00739973|147727882|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.91||0.001|TWO_SIDED|95.0|-4.77|-1.19|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-1.19|-4.77|0.001
74086951|NCT00739973|147727883|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.63|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-10.39|-6.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-6.87|-10.39|<0.001
73923145|NCT03255382|147375561|OTHER||Adjusted percentage difference|39.6|||<|0.001|TWO_SIDED|95.0|27.3|51.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||51.9|27.3|< 0.001
73923146|NCT03255382|147375562|OTHER||Adjusted percentage difference|36.3|||<|0.001|TWO_SIDED|95.0|24.1|48.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||48.5|24.1|< 0.001
73923147|NCT03255382|147375563|OTHER||Adjusted percentage difference|46.4|||<|0.001|TWO_SIDED|95.0|33.7|59.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||59.0|33.7|< 0.001
73923148|NCT03255382|147375564|OTHER||Adjusted percentage difference|9.9||||0.047|TWO_SIDED|95.0|0.1|19.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||19.7|0.1|0.047
73923149|NCT03255382|147375565|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.5|53.8|< 0.001
73923150|NCT03255382|147375566|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.3|79.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.9|53.3|< 0.001
73923151|NCT03255382|147375567|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.5|53.8|< 0.001
73923152|NCT03255382|147375568|OTHER||Adjusted percentage difference|56.5|||<|0.001|TWO_SIDED|95.0|43.0|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.0|43.0|< 0.001
73923153|NCT03255382|147375569|OTHER||Adjusted percentage difference|64.8|||<|0.001|TWO_SIDED|95.0|52.5|77.2|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||77.2|52.5|< 0.001
73923154|NCT03255382|147375570|OTHER||Adjusted percentage difference|1.7||||0.392|TWO_SIDED|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||5.4|-2.1|0.392
73923155|NCT03255382|147375571|OTHER||Adjusted percentage difference|36.6|||<|0.001|TWO_SIDED|95.0|23.8|49.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||49.3|23.8|< 0.001
73923156|NCT03255382|147375572|OTHER||Adjusted percentage difference|56.6|||<|0.001|TWO_SIDED|95.0|43.2|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.0|43.2|< 0.001
73923157|NCT03255382|147375573|OTHER||Adjusted percentage difference|64.9|||<|0.001|TWO_SIDED|95.0|51.5|78.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||78.3|51.5|< 0.001
73923158|NCT03255382|147375574|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.3|79.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.8|53.3|< 0.001
74086952|NCT00739973|147727884|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.17|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-9.94|-6.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-6.40|-9.94|<0.001
74086953|NCT00739973|147727885|SUPERIORITY_OR_OTHER||Least Sqaure Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.92||0.011|TWO_SIDED|95.0|-4.14|-0.53|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.53|-4.14|0.011
74086954|NCT00739973|147727886|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-10.81|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-12.57|-9.05|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-9.05|-12.57|<0.001
73923159|NCT03255382|147375575|OTHER||Adjusted percentage difference|0.0||||0.991|TWO_SIDED|95.0|-2.0|2.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||2.1|-2.0|0.991
73923160|NCT03255382|147375576|OTHER||Adjusted percentage difference|3.3||||0.323|TWO_SIDED|95.0|-3.2|9.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||9.8|-3.2|0.323
73923161|NCT03255382|147375577|OTHER||Adjusted percentage difference|21.5|||<|0.001|TWO_SIDED|95.0|10.4|32.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||32.6|10.4|< 0.001
73923162|NCT03255382|147375578|OTHER||Adjusted percentage difference|33.1|||<|0.001|TWO_SIDED|95.0|20.7|45.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||45.5|20.7|< 0.001
73923163|NCT03255382|147375579|OTHER||Adjusted percentage difference|41.3|||<|0.001|TWO_SIDED|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||55.3|27.3|< 0.001
73923164|NCT03255382|147375580|OTHER||Adjusted percentage difference|44.7|||<|0.001|TWO_SIDED|95.0|30.9|58.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||58.5|30.9|< 0.001
73923165|NCT03255382|147375581|OTHER||Least Squares Mean Difference|-7.19|STANDARD_ERROR_OF_MEAN|0.825|<|0.001|TWO_SIDED|95.0|-8.82|-5.56|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-5.56|-8.82|< 0.001
73923166|NCT03255382|147375582|OTHER||Least Squares Mean Difference|-9.58|STANDARD_ERROR_OF_MEAN|0.936|<|0.001|TWO_SIDED|95.0|-11.43|-7.72|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.72|-11.43|< 0.001
73923167|NCT03255382|147375583|OTHER||Least Squares Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|0.972|<|0.001|TWO_SIDED|95.0|-10.72|-6.87|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.87|-10.72|< 0.001
73923168|NCT03255382|147375584|OTHER||Least Squares Mean Difference|-7.78|STANDARD_ERROR_OF_MEAN|0.958|<|0.001|TWO_SIDED|95.0|-9.68|-5.88|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.88|-9.68|< 0.001
73923169|NCT03255382|147375585|OTHER||Least Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|1.101|<|0.001|TWO_SIDED|95.0|-10.07|-5.71|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.71|-10.07|< 0.001
73967901|NCT05481216|147473668|OTHER||Odds Ratio (OR)|0.99||||0.458|TWO_SIDED|95.0|0.95|1.02|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||1.02|0.95|0.458
74086955|NCT00739973|147727887|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.79|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.56|-3.03|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-3.03|-6.56|<0.001
74086956|NCT00739973|147727888|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.98|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|-5.78|-2.18|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-2.18|-5.78|<0.001
73923170|NCT03255382|147375586|OTHER||Least Squares Mean Difference|-8.39|STANDARD_ERROR_OF_MEAN|1.175|<|0.001|TWO_SIDED|95.0|-10.71|-6.06|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.06|-10.71|< 0.001
73923171|NCT03255382|147375587|OTHER||Adjusted percentage difference|29.7|||<|0.001|TWO_SIDED|95.0|17.1|42.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||42.4|17.1|< 0.001
73923172|NCT03255382|147375588|OTHER||Adjusted percentage difference|66.7|||<|0.001|TWO_SIDED|95.0|53.4|80.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||80.0|53.4|< 0.001
73923173|NCT03255382|147375589|OTHER||Adjusted percentage difference|56.8|||<|0.001|TWO_SIDED|95.0|42.7|70.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.8|42.7|< 0.001
73923174|NCT03255382|147375590|OTHER||Adjusted percentage difference|59.9|||<|0.001|TWO_SIDED|95.0|46.3|73.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||73.6|46.3|< 0.001
73923175|NCT03255382|147375591|OTHER||Adjusted percentage difference|44.9|||<|0.001|TWO_SIDED|95.0|30.8|59.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||59.1|30.8|< 0.001
73923176|NCT03255382|147375592|OTHER||Adjusted percentage difference|55.0|||<|0.001|TWO_SIDED|95.0|41.2|68.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||68.8|41.2|< 0.001
73923177|NCT03255382|147375593|OTHER||Adjusted percentage difference|1.7||||0.392|TWO_SIDED|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||5.4|-2.1|0.392
73923178|NCT03255382|147375594|OTHER||Adjusted percentage difference|8.4||||0.048|TWO_SIDED|95.0|0.1|16.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||16.7|0.1|0.048
74086957|NCT00739973|147727889|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-9.64|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-11.41|-7.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-7.87|-11.41|<0.001
73923179|NCT03255382|147375595|OTHER||Adjusted percentage difference|18.3||||0.001|TWO_SIDED|95.0|7.1|29.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||29.5|7.1|0.001
73923180|NCT03255382|147375596|OTHER||Adjusted percentage difference|33.0|||<|0.001|TWO_SIDED|95.0|20.2|45.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||45.9|20.2|< 0.001
73923181|NCT03255382|147375597|OTHER||Adjusted percentage difference|41.3|||<|0.001|TWO_SIDED|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||55.3|27.3|< 0.001
73923182|NCT03255382|147375598|OTHER||Adjusted percentage difference|46.4|||<|0.001|TWO_SIDED|95.0|32.6|60.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||60.1|32.6|< 0.001
73923183|NCT03255382|147375599|OTHER||Adjusted percentage difference|19.8||||0.001|TWO_SIDED|95.0|7.6|31.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||31.9|7.6|0.001
73923184|NCT03255382|147375600|OTHER||Adjusted percentage difference|38.3|||<|0.001|TWO_SIDED|95.0|25.0|51.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||51.5|25.0|< 0.001
73861795|NCT01149486|147269398|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.45|||||TWO_SIDED|90.0|93.15|106.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.18|93.15|
73923185|NCT03255382|147375601|OTHER||Least Squares Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.5|-2.0|||van Elteren test|||P-values were calculated by stratified van Elteren test.||-2.0|-4.5|< 0.001
73967902|NCT05481216|147473669|OTHER||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|1.61|4.57|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||4.57|1.61|<0.001
73967903|NCT05481216|147473670|OTHER||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.34|2.25|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||2.25|1.34|<0.001
73923186|NCT03255382|147375602|OTHER||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-5.1|-2.7|||van Elteren test|||P-values were calculated by stratified van Elteren test.||-2.7|-5.1|< 0.001
74086958|NCT00739973|147727890|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.26|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-8.0|-4.51|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-4.51|-8.00|<0.001
73923187|NCT03255382|147375603|OTHER||Least Squares Mean Difference|1.146|||<|0.001|TWO_SIDED|95.0|0.764|1.528|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||1.528|0.764|< 0.001
73923188|NCT03255382|147375604|OTHER||Least Squares Mean Difference|1.32|||<|0.001|TWO_SIDED|95.0|0.936|1.704|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||1.704|0.936|< 0.001
73923189|NCT03255382|147375605|OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-3.6|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.1|-3.6|< 0.001
73923190|NCT03255382|147375606|OTHER||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.66|<|0.001|TWO_SIDED|95.0|-4.3|-1.6|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.6|-4.3|< 0.001
73923191|NCT03255382|147375607|OTHER||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.307||0.352|TWO_SIDED|95.0|-0.9|0.32|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.32|-0.90|0.352
73923192|NCT03255382|147375608|OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.296||0.315|TWO_SIDED|95.0|-0.88|0.29|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.29|-0.88|0.315
73923193|NCT03255382|147375609|OTHER||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|-6.9|-2.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-2.7|-6.9|< 0.001
73923194|NCT03255382|147375610|OTHER||Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|-12.6|-6.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.1|-12.6|< 0.001
73923195|NCT03255382|147375611|OTHER||Least Squares Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|1.51|<|0.001|TWO_SIDED|95.0|-13.2|-7.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.2|-13.2|< 0.001
73923196|NCT03255382|147375612|OTHER||Least Squares Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|1.51|<|0.001|TWO_SIDED|95.0|-12.8|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.8|-12.8|< 0.001
73923197|NCT03255382|147375613|OTHER||Least Squares Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-12.4|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.8|-12.4|< 0.001
73923198|NCT03255382|147375614|OTHER||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|-12.9|-7.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.1|-12.9|< 0.001
73923199|NCT03255382|147375615|OTHER||Least Squares Mean Difference|4.49|STANDARD_ERROR_OF_MEAN|1.385||0.002|TWO_SIDED|95.0|1.74|7.23|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||7.23|1.74|0.002
73923200|NCT03255382|147375616|OTHER||Least Squares Mean Difference|4.63|STANDARD_ERROR_OF_MEAN|1.322|<|0.001|TWO_SIDED|95.0|2.01|7.25|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||7.25|2.01|< 0.001
73923201|NCT03255382|147375617|OTHER||Least Squares Mean Difference|6.66|STANDARD_ERROR_OF_MEAN|1.787|<|0.001|TWO_SIDED|95.0|3.11|10.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||10.20|3.11|< 0.001
73923202|NCT03255382|147375618|OTHER||Least Squares Mean Difference|7.85|STANDARD_ERROR_OF_MEAN|1.784|<|0.001|TWO_SIDED|95.0|4.31|11.38|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||11.38|4.31|< 0.001
73923203|NCT03255382|147375619|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.7|-1.2|< 0.001
73923204|NCT03255382|147375620|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.8|-1.3|< 0.001
73923205|NCT03255382|147375621|OTHER||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.2|-0.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.9|-3.2|< 0.001
73923206|NCT03255382|147375622|OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.5|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.1|-3.5|< 0.001
73923207|NCT03255382|147375623|OTHER||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-4.3|-1.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.9|-4.3|< 0.001
73923208|NCT03255382|147375624|OTHER||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-4.4|-1.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.8|-4.4|< 0.001
73923209|NCT03255382|147375625|OTHER||Adjusted percentage difference|38.3|||<|0.001|TWO_SIDED|95.0|23.6|53.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||53.1|23.6|< 0.001
73967904|NCT04005716|147473671|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.004|TWO_SIDED|95.0|0.61|0.93|||Log Rank|Stratified log rank test with ECOG performance status, and investigator chosen platinum as stratification factors.|The hazard ratio was estimated using a stratified Cox regression model with Efron's method for ties, stratified by ECOG performance status and investigator-selected platinum agents, with Arm B as the reference group.|The null hypothesis stated that the overall survival in Arm A (Tislelizumab + Chemotherapy) is less than or equal to that in Arm B (the placebo group), while the alternative hypothesis posits that the overall survival in Arm A is greater than that in Arm B.||0.93|0.61|0.0040
73967905|NCT04005716|147473672|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.78|||Log Rank|One-sided log-rank test p-value, stratified by ECOG performance status (1 vs 0) and type of platinum therapy (carboplatin vs cisplatin).|The hazard ratio was estimated using a stratified Cox regression model with Efron's method for ties, stratified by ECOG performance status and investigator-selected platinum agents, with Arm B as the reference group.|||0.78|0.52|<0.0001
74086959|NCT00739973|147727891|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.92||0.004|TWO_SIDED|95.0|-4.42|-0.83|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.83|-4.42|0.004
73923210|NCT03255382|147375626|OTHER||Adjusted percentage difference|56.8|||<|0.001|TWO_SIDED|95.0|42.7|70.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.9|42.7|< 0.001
73923211|NCT03255382|147375627|OTHER||Least Squares Mean Difference|-7.4|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|-9.6|-5.1|||ANCOVA|||P-values were calculated using ANCOVA with prior phototherapy (yes/no), baseline value, and treatment in the model.||-5.1|-9.6|< 0.001
73923212|NCT03255382|147375628|OTHER||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|-9.7|-5.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.5|-9.7|< 0.001
73923213|NCT03255382|147375629|OTHER||Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.23|<|0.001|TWO_SIDED|95.0|-9.0|-4.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-4.1|-9.0|< 0.001
73923214|NCT03255382|147375630|OTHER||Least Squares Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|1.53|<|0.001|TWO_SIDED|95.0|-11.1|-5.0|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.0|-11.1|< 0.001
73923215|NCT03255382|147375631|OTHER||Least Squares Mean Difference|0.087|STANDARD_ERROR_OF_MEAN|0.0215|<|0.001|TWO_SIDED|95.0|0.045|0.13|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.130|0.045|< 0.001
73923216|NCT03255382|147375632|OTHER||Least Squares Mean Difference|0.059|STANDARD_ERROR_OF_MEAN|0.0186||0.002|TWO_SIDED|95.0|0.022|0.096|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.096|0.022|0.002
73923217|NCT03255382|147375633|OTHER||Least Squares Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|9.4|20.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||20.5|9.4|< 0.001
73923218|NCT03255382|147375634|OTHER||Least Squares Mean Difference|16.8|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|11.4|22.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||22.2|11.4|< 0.001
73923219|NCT03255382|147375635|OTHER||Least Squares Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-16.6|-6.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-6.2|-16.6|< 0.001
73923220|NCT03255382|147375636|OTHER||Least Squares Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-19.1|-8.4|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-8.4|-19.1|< 0.001
73923221|NCT03255382|147375637|OTHER||Least Squares Mean Difference|-17.3|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-24.8|-9.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-9.8|-24.8|< 0.001
73923222|NCT03255382|147375638|OTHER||Least Squares Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-28.8|-14.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-14.2|-28.8|< 0.001
73923223|NCT03706794|147375674|SUPERIORITY||Mann-Whitney U|43.0||||0.829|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.829
73923224|NCT03706794|147375675|SUPERIORITY||Mann-Whitney U|45.5||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
73923225|NCT03706794|147375676|SUPERIORITY||Mann-Whitney U|45.5||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
73923226|NCT03706794|147375677|SUPERIORITY||Mann-Whitney U|46.0||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
73923227|NCT03706794|147375678|SUPERIORITY||Mann-Whitney U|52.0||||0.315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.315
73923228|NCT03526458|147375698|SUPERIORITY||Mean Difference (Final Values)|16.6|STANDARD_ERROR_OF_MEAN|5.6||0.012|TWO_SIDED|95.0|4.4|28.9|||t-test, 2 sided|||||28.9|4.4|0.012
73923229|NCT03526458|147375699|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|7.3||0.132|TWO_SIDED|95.0|-3.6|26.3|||t-test, 2 sided|||||26.3|-3.6|0.132
73923230|NCT03526458|147375700|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|2.7||0.654|TWO_SIDED|95.0|-4.4|6.9|||t-test, 2 sided|||||6.9|-4.4|0.654
74028482|NCT02940886|147610645|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.0001|TWO_SIDED|95.0|3.58|5.71|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."||5.71|3.58|<0.0001
74028483|NCT02940886|147610646|SUPERIORITY||Mean Difference (Final Values)|0.26|||<|0.0001|TWO_SIDED|95.0|0.19|0.34|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.34|0.19|<0.0001
73923231|NCT03526458|147375701|SUPERIORITY|||||||0.299|||||||Chi-squared|||||||0.299
73923232|NCT03526458|147375702|SUPERIORITY|||||||0.076|||||||Chi-squared|||||||0.076
73923233|NCT03526458|147375703|SUPERIORITY||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|143.9||0.943|TWO_SIDED|95.0|-286.0|306.8|||t-test, 2 sided|||||306.8|-286|0.943
73923234|NCT03526458|147375704|SUPERIORITY|||||||0.185|||||||Chi-squared|||||||0.185
73923235|NCT00529542|147375705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.58|TWO_SIDED|95.0|-9.3|5.3||All hypotheses tests were two-sided.|Linear mixed-effects models|Linear mixed-effects models were fit to continuous outcomes to assess the change from baseline to 6 weeks between groups.|This analysis revealed that the required sample size was 235 subjects per group for 80% power to detect an absolute 2% increase in FMD with Atorvastatin vs. Placebo. We stopped the trial because we had insufficient funds for the required sample size.|This study was initiated as a pilot study with the goal of enrolling 19 women in each group, which we hypothesized would provide 80% power to detect an absolute difference in the change in FMD from baseline between the two groups (Atorvastatin vs. Placebo) of 3.75%, assuming a common standard deviation (SD) of 4%, using a two-sided, two-sample t-test with α=0.05. Recruitment was slow due to strict inclusion/ exclusion criteria so we analyzed our data after the first 20 women completed the study.||5.3|-9.3|0.58
73923236|NCT00529542|147375706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.39|TWO_SIDED|95.0|-0.9|2.3|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||2.3|-0.9|0.39
73923237|NCT00529542|147375707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-70.8|||<|0.001|TWO_SIDED|95.0|-95.2|-46.4|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-46.4|-95.2|<0.001
73923238|NCT00529542|147375708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.6|||<|0.001|TWO_SIDED|95.0|-79.3|-35.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-35.9|-79.3|<0.001
73923239|NCT00529542|147375709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4||||0.26|TWO_SIDED|95.0|-2.7|9.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||9.5|-2.7|0.26
73923240|NCT00529542|147375710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-82.2|||<|0.001|TWO_SIDED|95.0|-126.2|-38.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-38.1|-126.2|<0.001
73923241|NCT00529542|147375711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.45|TWO_SIDED|95.0|-12.4|5.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||5.8|-12.4|0.45
73931076|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|9.84|||||TWO_SIDED|95.0|8.83|10.97|||||V116/PPSV23|Serotype 16F: V116/PPSV23 GMC Ratio||10.97|8.83|
73931077|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|7.59|||||TWO_SIDED|95.0|6.68|8.61|||||V116/PPSV23|Serotype 23A: V116/PPSV23 GMC Ratio||8.61|6.68|
73931078|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|4.79|||||TWO_SIDED|95.0|4.26|5.38|||||V116/PPSV23|Serotype 23B: V116/PPSV23 GMC Ratio||5.38|4.26|
73931079|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|21.19||||||95.0|18.98|23.65|||||V116/PPSV23|Serotype 24F: V116/PPSV23 GMC Ratio||23.65|18.98|
73861796|NCT01149486|147269399|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||TWO_SIDED|90.0|93.1|106.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.12|93.10|
73861797|NCT01149486|147269400|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|111.62|||||TWO_SIDED|90.0|101.47|122.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||122.79|101.47|
73923242|NCT00529542|147375712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.33|TWO_SIDED|95.0|-2.8|7.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||7.9|-2.8|0.33
73923243|NCT00529542|147375713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|586.0||||0.61|TWO_SIDED|95.0|-1811.0|2983.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||2983|-1811|0.61
73923244|NCT00529542|147375714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3385.0||||0.07|TWO_SIDED|95.0|-287.0|7056.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||7056|-287|0.07
73923245|NCT00529542|147375715|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.88|TWO_SIDED|95.0|-24.1|27.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||27.8|-24.1|0.88
73923246|NCT00529542|147375716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.6|-0.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-0.5|-1.6|<0.001
73923247|NCT00529542|147375717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-364.3||||0.02|TWO_SIDED|95.0|-655.3|-73.2|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-73.2|-655.3|0.02
73923248|NCT00529542|147375718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.21|TWO_SIDED|95.0|-6.4|1.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||1.5|-6.4|0.21
73923249|NCT00529542|147375719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9||||0.27|TWO_SIDED|95.0|-16.9|5.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||5.0|-16.9|0.27
73923250|NCT00529542|147375720|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.8||||0.05|TWO_SIDED|95.0|-15.8|0.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||0.1|-15.8|0.05
73923251|NCT00529542|147375721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.5||||0.48|TWO_SIDED|95.0|-6.8|13.7|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||13.7|-6.8|0.48
73923252|NCT00529542|147375722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.63|TWO_SIDED|95.0|-0.6|1.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||1.0|-0.6|0.63
73923253|NCT02587065|147375723|OTHER||Spearman's correlation coefficient|-0.85||||0.56|TWO_SIDED|95.0|-3.72|2.02|||Mixed-effects REML regression|||Adjusted change of convenience satisfaction domain of TSQM-9.||2.02|-3.72|0.56
73923254|NCT00827983|147375736|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-3.1||||0.37|TWO_SIDED|95.0|-9.9|3.7|||Chi-squared|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc\>= Pe + d(-10%) H1 : Pc\< Pe + d(-10%)"||3.7|-9.9|0.37
73967906|NCT04005716|147473673|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.9|1.96|||||Odds ratio was calculated using Cochran-Mantel-Haenszel estimates and stratified by ECOG performance (1 vs 0) and platinum (Carboplatin vs Cisplatin)|||1.96|0.90|
73923255|NCT00827983|147375737|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.1||||0.37|TWO_SIDED|95.0|-9.87|3.68|||Chi-squared|||||3.68|-9.87|0.37
73923256|NCT00827983|147375738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.33||0.85|TWO_SIDED|95.0|-4.7|5.8|||t-test, 2 sided|||||5.8|-4.7|0.85
73923257|NCT02113956|147375740|SUPERIORITY||Incident Rate Ratio (IRR)|1.42|||||TWO_SIDED|95.0|0.79|2.57|||Poisson regression||Adjusted for age and baseline number of condomless sex acts|||2.57|0.79|
73967907|NCT04005716|147473680|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.642|1.33|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-C30 Physical Functioning Score||1.330|0.642|
73967908|NCT04005716|147473680|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.473|1.123|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-LC13 Coughing Score||1.123|0.473|
73967909|NCT04005716|147473680|OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.485|1.057|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-LC13 Chest Pain Score||1.057|0.485|
73923258|NCT02113956|147375741|SUPERIORITY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.36|1.12|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|1.12|0.36|
73923259|NCT02113956|147375742|SUPERIORITY||Incident Rate Ratio|0.95|||||TWO_SIDED|95.0|0.45|2.02|||Poisson||||Adjusted for age and baseline number of condomless sex acts|2.02|0.45|
73923260|NCT02113956|147375743|SUPERIORITY||Incident Rate Ratio (IRR)|0.62|||||TWO_SIDED|95.0|0.12|3.18|||Poisson||||Adjusted for age and baseline number of condomless sex acts|3.18|0.12|
73923261|NCT02113956|147375744|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.23|0.997|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|0.997|0.23|
73923262|NCT02113956|147375745|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.38|2.53|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|2.53|0.38|
73923263|NCT02113956|147375746|SUPERIORITY||Odds Ratio (OR)|3.42|||||TWO_SIDED|95.0|1.65|7.09|||Regression, Logistic||||Adjusted for age and baseline rate of HIV testing|7.09|1.65|
73923264|NCT02113956|147375747|SUPERIORITY||Incident Risk Ratio (IRR)|0.58|||||TWO_SIDED|95.0|0.22|1.5|||Poisson||||Adjusted for age and baseline number of condomless sex acts|1.5|0.22|
73923265|NCT02113956|147375748|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.6|2.09|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|2.09|0.6|
73923266|NCT02113956|147375749|SUPERIORITY||Incident Rate Ratio (IRR)|0.6|||||TWO_SIDED|95.0|0.22|1.68|||||||Adjusted for age and baseline number of condomless sex acts|1.68|0.22|
73923267|NCT02113956|147375750|SUPERIORITY||Incident Rate Ratio (IRR)|1.1|||||TWO_SIDED|95.0|0.01|92.03|||||||Adjusted for age and baseline number of condomless sex acts|92.03|0.01|
73923268|NCT02113956|147375751|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.46|1.88|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|1.88|0.46|
73923269|NCT02113956|147375752|SUPERIORITY||Odds Ratio (OR)|3.4|||||TWO_SIDED|95.0|0.88|16.95|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|16.95|0.88|
73923270|NCT02113956|147375753|SUPERIORITY||Odds Ratio (OR)|3.39|||||TWO_SIDED|95.0|1.52|7.58|||Regression, Logistic||||Adjusted for age and baseline rate of HIV testing|7.58|1.52|
73923271|NCT01602380|147375754|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.797||||0.0486|TWO_SIDED|95.0|0.637|0.999||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A hazard ratio \< 1 favours fulvestrant.|If the true PFS HR for comparison of fulvestrant vs. anastrozole was 0.69 (likely to correspond to a 45% prolongation of PFS) the study had 90% power to demonstrate a statistically significant difference for PFS with a one-sided type 1 error of 2.5% (two-sided 5%).||0.999|0.637|0.0486
73967910|NCT02120456|147473690|SUPERIORITY||Rate ratio|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.58|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.58|0.34|<0.001
73967911|NCT02120456|147473690|SUPERIORITY||Rate ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.44|0.73|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.73|0.44|<0.001
73923272|NCT01602380|147375755|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.966||||0.7579|TWO_SIDED|95.0|0.773|1.206||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A HR of \<1 favours fulvestrant.|65% OS maturity||1.206|0.773|0.7579
73923273|NCT01602380|147375756|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.074||||0.729|TWO_SIDED|95.0|0.716|1.614||2-sided p-value|Regression, Logistic|||||1.614|0.716|0.7290
73923274|NCT01602380|147375758|SUPERIORITY_OR_OTHER_LEGACY||Rato of EDoR|1.52||||0.0367|TWO_SIDED|95.0|1.03|2.26||2-sided p-value|Method of Ellis et al|||||2.26|1.03|0.0367
73923275|NCT01602380|147375759|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.253||||0.3045|TWO_SIDED|95.0|0.815|1.932||2-sided p-value|Regression, Logistic|||||1.932|0.815|0.3045
73923276|NCT01602380|147375761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of EDoCB|1.26||||0.0561||95.0|0.99|1.59||2-sided p-value|Method of Ellis et al|||||1.59|0.99|0.0561
73923277|NCT01602380|147375762|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.2846|TWO_SIDED|95.0|0.7|1.11||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline|A hazard ratio \< 1 favours fulvestrant.|Comparative statistical analysis for time to deterioration of TOI score is presented (fulvestrant versus anastrozole).||1.11|0.70|0.2846
73923278|NCT01602380|147375762|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0844|TWO_SIDED|95.0|0.66|1.03||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline|A hazard ratio \< 1 favours fulvestrant.|Comparative statistical analysis for time to deterioration of FACT-B total score is presented (fulvestrant versus anastrozole).||1.03|0.66|0.0844
73923279|NCT02921776|147375769|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
73923280|NCT02921776|147375770|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.55
73923281|NCT02921776|147375771|OTHER|||||||0.1|||||||Effect size|Effect size =-0.29||||||0.10
73923282|NCT02921776|147375771|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||.10
73923283|NCT02921776|147375772|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Benzodiazepine exposure||||0.02
73923284|NCT02921776|147375772|SUPERIORITY|||||||0.291|||||||Mixed Models Analysis|||Opioid Exposure||||0.291
73923285|NCT02921776|147375773|SUPERIORITY||Mean Difference (Final Values)|3.04||||0.38|TWO_SIDED||||||t-test, 2 sided|||||||0.38
73923286|NCT02921776|147375774|SUPERIORITY|||||||0.32|TWO_SIDED|95.0|||||Chi-squared|||||||0.32
73923287|NCT02921776|147375775|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.19|4.72|||Mixed Models Analysis|||||4.72|0.19|0.93
73967912|NCT02120456|147473690|SUPERIORITY||Rate ratio|1.26||||0.058|TWO_SIDED|95.0|0.99|1.6|||Negative binominal regression|||||1.60|0.99|0.058
73967913|NCT02120456|147473691|SUPERIORITY||Ratio of clearance rates|1.05||||0.94|TWO_SIDED|95.0|0.3|4.73|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||4.73|0.30|0.94
73967914|NCT02120456|147473691|SUPERIORITY||Ratio of clearance rates|1.0||||1|TWO_SIDED|95.0|0.28|4.51|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||4.51|0.28|1.00
73923288|NCT02921776|147375776|SUPERIORITY||Mean Difference (Final Values)|10.6||||0.07|TWO_SIDED||||||t-test, 2 sided|||||||0.07
73923289|NCT02921776|147375778|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
73923290|NCT02921776|147375779|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Baseline||||0.94
73923291|NCT02921776|147375779|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Patient Extubation or Discharge from ICU||||0.89
73923292|NCT02921776|147375779|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||1-Month||||0.38
73923293|NCT02921776|147375779|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||3-Month||||0.63
73923294|NCT02921776|147375779|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||.73
73923295|NCT02921776|147375780|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Baseline||||0.82
73923296|NCT02921776|147375780|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||Patient extubation or discharge from ICU||||0.84
73967915|NCT02120456|147473691|SUPERIORITY||Ratio of clearance rates|0.95||||0.93|TWO_SIDED|95.0|0.31|2.89|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||2.89|0.31|0.93
73967916|NCT02120456|147473692|SUPERIORITY||Ratio of clearance rates|2.88||||0.003|TWO_SIDED|95.0|1.36|7.85|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||7.85|1.36|0.003
73967917|NCT02120456|147473692|SUPERIORITY||Ratio of clearance rates|2.84||||0.004|TWO_SIDED|95.0|1.35|7.74|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||7.74|1.35|0.004
73967918|NCT02120456|147473692|SUPERIORITY||Ratio of clearance rates|0.99||||0.95|TWO_SIDED|95.0|0.66|1.47|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||1.47|0.66|0.95
73967919|NCT02243709|147473715|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
73923297|NCT02921776|147375780|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||1-month||||0.96
73923298|NCT02921776|147375780|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||3-Month||||0.17
73967920|NCT04169373|147473734|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|26.4|||<|0.0001|TWO_SIDED|95.0|17.9|34.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.||34.9|17.9|<0.0001
73967921|NCT04169373|147473735|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|22.2|||<|0.0001|TWO_SIDED|95.0|12.1|32.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP status.|Response Rate Difference = Upadacitinib - Placebo|"Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.~Binary endpoints in Study 2 were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the main stratification factor of positivity for MRI inflammation in the sacroiliac joints and screening hsCRP status (MRI-positive and hsCRP \> ULN vs MRI-positive and hsCRP ≤ ULN vs MRI-negative and hsCRP \> ULN)."||32.3|12.1|<0.0001
73923299|NCT02921776|147375780|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||.39
73923300|NCT02921776|147375781|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||1-month||||0.26
73923301|NCT02921776|147375781|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||3-month||||0.25
73923302|NCT02921776|147375781|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||6-month||||0.79
73923303|NCT02921776|147375789|SUPERIORITY||Odds Ratio (OR)|0.23||||0.05|TWO_SIDED|95.0|0.05|1.01|||t-test, 2 sided|||||1.01|0.05|0.05
73923304|NCT02921776|147375789|SUPERIORITY||Odds Ratio (OR)|0.27||||0.1|TWO_SIDED|95.0|0.06|1.3|||Regression, Linear|||Adjusted for baseline communication difficulty||1.30|0.06|0.10
73923305|NCT03939897|147375850|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.506|||||||Log Rank|||||||0.5060
73923306|NCT03939897|147375853|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.2989|||||||Log Rank|||||||0.2989
73923307|NCT00380978|147375874|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence|Risk Ratio (RR)|1.04||||0.65|TWO_SIDED|95.0|0.9|1.2|||Chi-squared, Corrected|||Group sample sizes of 800 in each group achieve 80% power to detect equivalence when the margin of equivalence extends from 0.1 to 0.25||1.20|0.90|0.65
73923308|NCT00380978|147375875|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98||||0.63|TWO_SIDED|95.0|0.8|1.2|||Chi-squared|||There rate of instrumented vaginal delivery will be equal in both groups.||1.20|0.80|0.63
73923309|NCT00380978|147375876|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Log Rank|||||||0.047
73923310|NCT00380978|147375877|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Chi-squared|||||||0.35
73923311|NCT00380978|147375878|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0|||<|0.005|TWO_SIDED|95.0|-4.0|-3.0|||Wilcoxon (Mann-Whitney)|||||-3|-4|<0.005
73923312|NCT00380978|147375879|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Chi-squared, Corrected|||||||<0.005
73923313|NCT00380978|147375880|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Fisher Exact|||||||0.11
73923314|NCT00380978|147375881|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Chi-squared, Corrected|||||||<0.005
73923315|NCT01729754|147375884|SUPERIORITY||Difference in percentages|59.8|||<|0.001|TWO_SIDED|95.0|52.9|65.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and confidence intervals (CIs) are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||65.9|52.9|<0.001
73923316|NCT01729754|147375884|SUPERIORITY||Difference in percentages|55.5|||<|0.001|TWO_SIDED|95.0|48.3|61.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||61.8|48.3|<0.001
73923317|NCT01729754|147375885|SUPERIORITY||Difference in percentages|54.7|||<|0.001|TWO_SIDED|95.0|47.9|60.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||60.8|47.9|<0.001
73923318|NCT01729754|147375885|SUPERIORITY||Difference in percentages|50.2|||<|0.001|TWO_SIDED|95.0|43.2|56.5||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||56.5|43.2|<0.001
73923319|NCT01729754|147375888|SUPERIORITY||Difference in percentages|19.2|||<|0.001|TWO_SIDED|95.0|11.5|26.7||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||26.7|11.5|<0.001
73923320|NCT01729754|147375888|SUPERIORITY||Difference in percentages|20.1|||<|0.001|TWO_SIDED|95.0|12.4|27.6||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||27.6|12.4|<0.001
73923321|NCT01729754|147375891|SUPERIORITY||Difference in percentages|24.1|||<|0.001|TWO_SIDED|95.0|16.2|31.7|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||31.7|16.2|<0.001
73923322|NCT01729754|147375891|SUPERIORITY||Difference in percentages|19.6|||<|0.001|TWO_SIDED|95.0|11.7|27.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights|||27.3|11.7|<0.001
73923323|NCT01729754|147375894|SUPERIORITY||Difference in percentages|35.3|||<|0.001|TWO_SIDED|95.0|29.2|41.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||41.1|29.2|<0.001
73923324|NCT01729754|147375894|SUPERIORITY||Difference in percentages|37.5|||<|0.001|TWO_SIDED|95.0|31.1|43.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights|||43.4|31.1|<0.001
73931080|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|8.69|||||TWO_SIDED|95.0|7.82|9.65|||||V116/PPSV23|Serotype 31: V116/PPSV23 GMC Ratio||9.65|7.82|
73931081|NCT05569954|147391867|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|15.53|||||TWO_SIDED|95.0|14.13|17.07|||||V116/PPSV23|Serotype 35B: V116/PPSV23 GMC Ratio||17.07|14.13|
73931082|NCT01660412|147391871|OTHER||Mean Difference (Final Values)|1.42|STANDARD_DEVIATION|2.17|<|0.0001|TWO_SIDED|95.0|0.85|2.0|||t-test, 2 sided|||||2.00|0.85|<0.0001
73931083|NCT06893809|147391883|SUPERIORITY||Median Difference (Net)|10.0|STANDARD_DEVIATION|5.0||0.05|TWO_SIDED|95.0|10.0|20.0|||Kruskal-Wallis|||Sixty male patients scheduled for TURP surgery were divided into three equal groups. The results were evaluated at a 95% confidence interval, with significance set at p \< 0.05. This was achieved using SPSS 15.0. Between-group comparisons were performed using One-way ANOVA, Kruskal-Wallis, Wilcoxon Signed Ranks, and Friedman tests. Within-group comparisons used Wilcoxon Signed Ranks tests, and Friedman tests were used for differences over time.||20|10|0.05
73931084|NCT06893809|147391883|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0|>|0.05|TWO_SIDED|95.0|0.0|0.0||No adjustment for multiple comparisons was applied. Non-parametric method used due to ordinal scale structure.|Kruskal-Wallis||Patient and surgeon satisfaction were compared across study arms.|The aim of this analysis is to compare the three groups in terms of patient and surgeon satisfaction using a superiority approach. The null hypothesis is that there is no difference in satisfaction scores between the groups. Statistical significance was set at p \< 0.05.||0|0|>0.05
73931085|NCT06893809|147391885|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.05|TWO_SIDED|95.0|0.5|1.6|||Kruskal-Wallis|Non-parametric test used due to ordinal scale and non-normal distribution.|Sensory block levels compared across study arms using numerical dermatomal codes.|||1.6|0.5|0.05
73931086|NCT06893809|147391887|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.22|<|0.05|TWO_SIDED|95.0|0.07|0.93|||Kruskal-Wallis||Dermatomal regression levels were compared across groups at 60 minutes.|||0.93|0.07|<0.05
73931087|NCT04524403|147391920|SUPERIORITY||Least Squares Mean Difference|0.24||||0.787|TWO_SIDED|95.0|-1.52|2.01|||Mixed Models Analysis|||||2.01|-1.52|0.7870
73931088|NCT04524403|147391920|SUPERIORITY||Least Squares Mean Difference|0.75||||0.4018|TWO_SIDED|95.0|-1.01|2.51|||Mixed Models Analysis|||||2.51|-1.01|0.4018
73931089|NCT04524403|147391921|SUPERIORITY||Least Squares Mean Difference|0.5||||0.5228|TWO_SIDED|95.0|-1.03|2.02|||Mixed Models Analysis|||||2.02|-1.03|0.5228
73967922|NCT04169373|147473735|OTHER||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|1.7|4.5|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.5|1.7|
73923325|NCT01729754|147375894|SUPERIORITY||Difference in percentages|15.2|||<|0.001|TWO_SIDED|95.0|8.3|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.1|8.3|<0.001
73967923|NCT04169373|147473736|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Least Squares (LS) Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.85|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.85|-1.20|<0.0001
73967924|NCT04169373|147473737|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.47|-2.33|||ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.33|-5.47|<0.0001
73923326|NCT01729754|147375894|SUPERIORITY||Difference in percentages|17.4|||<|0.001|TWO_SIDED|95.0|10.3|24.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||24.4|10.3|<0.001
73923327|NCT01729754|147375895|OTHER||Difference in percentages|27.1|||<|0.001|TWO_SIDED|95.0|19.1|34.7||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||34.7|19.1|<0.001
73923328|NCT01729754|147375895|OTHER||Difference in percentages|24.9|||<|0.001|TWO_SIDED|95.0|17.0|32.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||32.6|17.0|<0.001
73923329|NCT01729754|147375898|SUPERIORITY||Difference in percentages|11.7|||<|0.001|TWO_SIDED|95.0|7.8|16.0|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||16.0|7.8|<0.001
73923330|NCT01729754|147375898|SUPERIORITY||Difference in percentages|12.4|||<|0.001|TWO_SIDED|95.0|8.5|16.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||16.6|8.5|<0.001
73923331|NCT01729754|147375898|SUPERIORITY||Difference in percentages|7.0||||0.001|TWO_SIDED|95.0|2.8|11.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||11.6|2.8|0.001
73923332|NCT01729754|147375898|SUPERIORITY||Difference in percentages|7.6|||<|0.001|TWO_SIDED|95.0|3.3|12.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||12.3|3.3|<0.001
73967925|NCT04169373|147473738|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|26.4|||<|0.0001|TWO_SIDED|95.0|18.0|34.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||34.8|18.0|<0.0001
73967926|NCT04169373|147473739|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.9|36.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||36.3|17.9|<0.0001
74086960|NCT00739973|147727892|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-11.1|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-12.85|-9.35|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-9.35|-12.85|<0.001
73923333|NCT01729754|147375899|SUPERIORITY||Difference in percentages|15.7|||<|0.001|TWO_SIDED|95.0|9.4|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.1|9.4|<0.001
73923334|NCT01729754|147375899|SUPERIORITY||Difference in percentages|11.7|||<|0.001|TWO_SIDED|95.0|5.6|17.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||17.9|5.6|<0.001
73923335|NCT01729754|147375903|OTHER||Difference in least squares means|-8.2|||<|0.001|TWO_SIDED|95.0|-9.3|-7.2|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-7.2|-9.3|<0.001
73923336|NCT01729754|147375903|OTHER||Difference in least squares means|-8.3|||<|0.001|TWO_SIDED|95.0|-9.3|-7.3|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-7.3|-9.3|<0.001
73923337|NCT01729754|147375903|OTHER||Difference in least squares means|-1.3||||0.002|TWO_SIDED|95.0|-2.1|-0.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-0.5|-2.1|0.002
73923338|NCT01729754|147375903|OTHER||Difference in least squares means|-1.4||||0.001|TWO_SIDED|95.0|-2.2|-0.6|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-0.6|-2.2|0.001
73923339|NCT01729754|147375904|OTHER||Difference in least squares means|-1.7|||<|0.001|TWO_SIDED|95.0|-2.4|-1.0|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-1.0|-2.4|<0.001
73923340|NCT01729754|147375904|OTHER||Difference in least squares means|-2.2|||<|0.001|TWO_SIDED|95.0|-2.9|-1.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-1.5|-2.9|<0.001
73923341|NCT01729754|147375907|OTHER||Difference in percentages|39.3|||<|0.001|TWO_SIDED|95.0|31.8|46.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||46.1|31.8|<0.001
73923342|NCT01729754|147375907|OTHER||Difference in percentages|32.1|||<|0.001|TWO_SIDED|95.0|24.5|39.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||39.1|24.5|<0.001
73931090|NCT04524403|147391922|SUPERIORITY||Odds Ratio (OR)|1.781||||0.2537|TWO_SIDED|95.0|0.661|4.802|||Regression, Logistic|||||4.802|0.661|0.2537
73931091|NCT04524403|147391922|SUPERIORITY||Odds Ratio (OR)|0.916||||0.874|TWO_SIDED|95.0|0.308|2.722|||Regression, Logistic|||||2.722|0.308|0.8740
73931092|NCT04524403|147391923|SUPERIORITY||Least Squares Mean Difference|0.0||||0.987|TWO_SIDED|95.0|-0.021|0.021|||Mixed Models Analysis|||||0.021|-0.021|0.9870
73931093|NCT04524403|147391923|SUPERIORITY||Least Squares Mean Difference|0.008||||0.4624|TWO_SIDED|95.0|-0.013|0.029|||Mixed Models Analysis|||||0.029|-0.013|0.4624
73931094|NCT00368940|147391927|SUPERIORITY||Cohen D at week 12|0.6||||0.005|TWO_SIDED|95.0|0.13|1.06|||Mixed Models Analysis|||||1.06|0.13|0.005
73931095|NCT00368940|147391928|SUPERIORITY||Cohen D at week 12|0.67||||0.001|TWO_SIDED|95.0|0.2|1.14|||Mixed Models Analysis|||||1.14|0.20|0.001
73931096|NCT00368940|147391929|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||||||0.0268
73931097|NCT00368940|147391930|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73931098|NCT01221441|147391967|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
73931099|NCT01221441|147391968|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
73931100|NCT01221441|147391969|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The efficacy evaluation at week 104 evaluated KOOS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for KOOS is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
73931101|NCT01221441|147391970|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The efficacy evaluation at week 104 evaluated Lysholm score with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for Lysholm score is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
74086961|NCT00739973|147727893|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.83|STANDARD_ERROR_OF_MEAN|1.48||0.056|TWO_SIDED|95.0|-5.73|-0.07|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.07|-5.73|0.056
74086962|NCT00739973|147727894|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-17.08|STANDARD_ERROR_OF_MEAN|1.44|<|0.001||95.0|-19.91|-14.3|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-14.3|-19.91|<0.001
74086963|NCT00739973|147727895|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.45|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-9.29|-3.62|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-3.62|-9.29|<0.001
74086964|NCT00739973|147727896|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-8.9|-3.11|||ANCOVA|A two-way analysis of covariance model with treatment and region asntwo factors, and the baseline as a covariate.||||-3.11|-8.90|<0.001
73923343|NCT01729754|147375907|OTHER||Difference in percentages|11.9||||0.003|TWO_SIDED|95.0|4.1|19.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||19.5|4.1|0.003
73923344|NCT01729754|147375907|OTHER||Difference in percentages|4.8||||0.221|TWO_SIDED|95.0|-2.9|12.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||12.5|-2.9|0.221
73923345|NCT01729754|147375908|OTHER||Difference in percentages|25.7|||<|0.001|TWO_SIDED|95.0|17.7|33.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||33.4|17.7|<0.001
73923346|NCT01729754|147375908|OTHER||Difference in percentages|15.0|||<|0.001|TWO_SIDED|95.0|6.9|22.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.9|6.9|<0.001
73923347|NCT00773292|147375918|OTHER|change from baseline||||||0.24|||||||t-test, 2 sided|||||||0.24
73923348|NCT04608500|147375925|SUPERIORITY||Mean Difference (Final Values)|3.85|STANDARD_ERROR_OF_MEAN|0.861|<|0.0001|TWO_SIDED|95.0|2.16|5.54|||ANCOVA|Analysis of covariance (ANCOVA) model includes treatment, Baseline inflammatory lesion count, and analysis center.||||5.54|2.16|<0.0001
73923349|NCT04608500|147375926|SUPERIORITY||Risk Ratio (RR)|1.263||||0.0077|TWO_SIDED|95.0|1.064|1.499||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||||1.499|1.064|0.0077
73923350|NCT04608500|147375927|SUPERIORITY||Risk Ratio (RR)|1.193||||0.0189|TWO_SIDED|95.0|1.024|1.39||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.390|1.024|0.0189
73967927|NCT04169373|147473740|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|10.9|||<|0.0001|TWO_SIDED|95.0|6.0|15.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||15.8|6.0|<0.0001
73967928|NCT04169373|147473741|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.96|-1.11|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.11|-1.96|<0.0001
73967929|NCT04169373|147473742|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.14|-1.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.24|-2.14|<0.0001
74086965|NCT00739973|147727897|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-15.03|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-17.88|-12.2|||ANCOVA|||||-12.2|-17.88|<0.001
74086966|NCT00739973|147727898|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.82|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-10.63|-5.02|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-5.02|-10.63|<0.001
74086967|NCT00739973|147727899|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.16|STANDARD_ERROR_OF_MEAN|1.47||0.143|TWO_SIDED|95.0|-5.04|0.73|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||0.73|-5.04|0.143
74086968|NCT00739973|147727900|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-16.4|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-19.21|-13.6|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-13.6|-19.21|<0.001
73923351|NCT04608500|147375928|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|2.672|<|0.0001|TWO_SIDED|95.0|6.05|16.54|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||||16.54|6.05|<0.0001
73923352|NCT04608500|147375929|SUPERIORITY||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|0.821|<|0.0001|TWO_SIDED|95.0|2.77|5.99|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||Statistical Analysis For Week 4||5.99|2.77|<0.0001
73923353|NCT04608500|147375929|SUPERIORITY||Mean Difference (Final Values)|5.07|STANDARD_ERROR_OF_MEAN|0.793|<|0.0001|TWO_SIDED|95.0|3.52|6.63|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||Statistical Analysis For Week 8||6.63|3.52|<0.0001
73923354|NCT04608500|147375930|SUPERIORITY||Risk Ratio (RR)|1.715||||0.0114|TWO_SIDED|95.0|1.129|2.605||p-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical Analysis For Week 4||2.605|1.129|0.0114
73923355|NCT04608500|147375930|SUPERIORITY||Risk Ratio (RR)|1.319||||0.0061|TWO_SIDED|95.0|1.082|1.607||p-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical Analysis For Week 8||1.607|1.082|0.0061
73923356|NCT01959542|147375952|OTHER|Pearson's product-moment correlation|Pearson's product-moment correlation|-0.53||||0.09|TWO_SIDED|95.0|-86.0|0.1|||Pearson's product-moment correlation|||||0.10|-086|0.09
73923357|NCT01959542|147375953|OTHER||Pearson's product-moment correlation|-0.62||||0.03|TWO_SIDED|95.0|-0.62|-0.15|||Pearson's product-moment correlation|Pearson's product moment correlation||||-0.15|-0.62|0.03
73923358|NCT03388138|147375975|NON_INFERIORITY|Non-inferiority of the etafilcon A with ketotifen lens relative to the etafilcon A lens was established if the upper limit of the 95% confidence interval was below 0.1 logMAR.|Least-Square Mean Difference|0.0017|STANDARD_ERROR_OF_MEAN|0.01169|||TWO_SIDED|95.0|-0.021|0.025|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as etafilcon A with ketotifen - etafilcon A|||0.025|-0.021|
73923359|NCT03388138|147375976|NON_INFERIORITY|Non-inferiority of the etafilcon A with ketotifen lens relative to the etafilcon A lens was established if the upper limit of the 95% confidence interval was below 0.1 logMAR.|Least-Square Mean Difference|0.0007|STANDARD_ERROR_OF_MEAN|0.01158|||TWO_SIDED|95.0|-0.022|0.024|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as etafilcon A with ketotifen - etafilcon A|||0.024|-0.022|
73923360|NCT01268111|147375979|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|||||||0.4
73923361|NCT00587483|147376009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.427|TWO_SIDED|95.0|0.48|1.37||An alpha of 0.0167 was used to account for multiple comparisons among the 3 groups. Given the total of 3 comparisons, 0.05/3 = 0.0167 was used in the calculation.|Regression, Logistic|||The expected overall incidence of ventricular fibrillation after removal of the aortic clamp is at least 70%. Using a chi square analysis with 80% power and an alpha of 0.0167, we estimate that we will need 113 patients in each group to show a 30% reduction in the incidence of ventricular fibrillation with amiodarone.||1.37|0.48|0.427
73923362|NCT00587483|147376009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.117|TWO_SIDED|95.0|0.39|1.11|||Regression, Logistic|||||1.11|0.39|0.117
73967930|NCT04169373|147473743|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|34.0|||<|0.0001|TWO_SIDED|95.0|26.2|41.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||41.8|26.2|<0.0001
73923363|NCT00587483|147376009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.433|TWO_SIDED|95.0|0.47|1.37|||Regression, Logistic|||||1.37|0.47|0.433
73923364|NCT00587483|147376010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.215|TWO_SIDED|95.0|0.45|1.19|||Regression, Logistic|||||1.19|0.45|0.215
73923365|NCT00587483|147376010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.008|TWO_SIDED|95.0|0.32|0.84|||Regression, Logistic|||||0.84|0.32|0.008
73923366|NCT00587483|147376010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.424|TWO_SIDED|95.0|0.52|1.33|||Regression, Logistic|||||1.33|0.52|0.424
74028484|NCT02940886|147610646|SUPERIORITY||Mean Difference (Final Values)|0.29|||<|0.0001|TWO_SIDED|95.0|0.19|0.38|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.38|0.19|<0.0001
74028485|NCT02940886|147610646|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.1091|TWO_SIDED|95.0|-0.02|0.2|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.20|-0.02|0.1091
74028486|NCT02940886|147610647|SUPERIORITY||Mean Difference (Final Values)|267.7|||<|0.0001|TWO_SIDED|95.0|246.3|289.0|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||289.0|246.3|<0.0001
73861798|NCT01149486|147269401|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||TWO_SIDED|90.0|99.58|112.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.41|99.58|
73967931|NCT04169373|147473744|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.17|||<|0.0001|TWO_SIDED|95.0|-1.55|-0.8|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.80|-1.55|<0.0001
73861799|NCT01149486|147269402|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.55|||||TWO_SIDED|90.0|99.64|111.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.82|99.64|
73923367|NCT02063516|147376025|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||It was calculated that 80 adult patients randomized from different surgical department would have 80% power to detect a difference in 2 point in mean. Sampling size was determined using 2 sided t-test (alpha=0.05).||||0.04
73923368|NCT02063516|147376026|SUPERIORITY_OR_OTHER|||||||0.836|TWO_SIDED|95.0|||||Chi-squared|||||||0.836
73923369|NCT02063516|147376027|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 30 minutes to maintain cuff pressure 60cmH2O||||0.0035
73923370|NCT02063516|147376027|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 60 minutes to maintain cuff pressure 60cmH2O||||0.003
73923371|NCT02063516|147376027|SUPERIORITY_OR_OTHER|||||||0.0042|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 90 minutes to maintain cuff pressure 60cmH2O||||0.0042
73923372|NCT02063516|147376027|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 120 minutes to maintain cuff pressure 60cmH2O||||0.004
73923373|NCT01996826|147376038|OTHER|Based on prior studies endothelial rejection episodes tend to occur in the range of about 60% of transplants. We used rates ranging from 50 to 70 % to compute the sample size. We specified the probability of a type 1 error equal to 0.05, study power equal to 80%, a follow-up period of 12 months, and 4% loss to follow-up. Calculations resulted in sample size estimates of between 65 and 124 participants.|Hazard Ratio (HR)|0.35||||0.1|TWO_SIDED|95.0|0.12|1.14|||Log Rank|||Endothelial rejection rates in patients in the treatment group and the control group were calculated using the Kaplan-Meier survival curve. The Kaplan-Meier/product limit estimator is a non-parametric statistical test used to show the probability of an event occurring at a given time interval. The Kaplan-Meier estimator is used to show what the probability of corneal transplant rejection (and therefore transplant survival) after administration of the active treatment or control.||1.14|0.12|0.10
73967932|NCT04169373|147473745|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|13.2|||<|0.0001|TWO_SIDED|95.0|7.4|19.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||19.0|7.4|<0.0001
73967933|NCT04169373|147473746|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.07|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.24|-3.90|<0.0001
73967934|NCT04169373|147473747|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.47|-1.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.24|-2.47|<0.0001
73923374|NCT01996826|147376039|OTHER|The count of ocular adverse events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.|Risk Ratio (RR)|0.92||||0.36|TWO_SIDED|95.0|0.78|1.06|||Fisher Exact|||The incidence of Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||1.06|0.78|0.36
73923375|NCT01996826|147376039|OTHER|Mild ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.63|1.4|||Fisher Exact|||The number of mild severity Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||1.4|0.63|0.82
73861800|NCT01149486|147269403|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.78|||||TWO_SIDED|90.0|98.96|115.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||115.23|98.96|
73923376|NCT01996826|147376039|OTHER|Moderate severity ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.95|||>|0.99|TWO_SIDED|95.0|0.41|2.2|||Fisher Exact|||The number of moderate severity Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||2.2|0.41|>0.99
73923377|NCT01996826|147376039|OTHER|Severe ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.63||||0.51|TWO_SIDED|95.0|0.2|1.9|||Fisher Exact|||Severe ocular adverse events for subjects in intervention group and control group were counted and compared.||1.9|0.20|0.51
73923378|NCT01996826|147376040|OTHER|The incidence of Systematic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were calculated and compared.|Risk Ratio (RR)|0.92||||0.24|TWO_SIDED|95.0|0.79|1.02|||Fisher Exact|||||1.02|0.79|0.24
73923379|NCT01996826|147376040|OTHER|Mild severity systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.62||||0.4|TWO_SIDED|95.0|0.68|3.9|||Fisher Exact|||The number of mild systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||3.9|0.68|0.40
73923380|NCT01996826|147376040|OTHER|Moderate severity systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.95|||>|0.99|TWO_SIDED|95.0|0.26|14.5|||Fisher Exact|||The number of moderate severity systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||14.5|0.26|>0.99
73923381|NCT01996826|147376040|OTHER|Severe systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.9|||>|0.99|TWO_SIDED|95.0|0.26|14.5|||Fisher Exact|||The number of severe systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||14.5|0.26|>0.99
73923382|NCT01514760|147376050|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANCOVA|||This a comparison for participants with uncontrolled asthma at baseline and change in scores over time.||||0.03
73923383|NCT02418468|147376058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.262|TWO_SIDED|95.0|-0.26|0.07|||mixed models for repeated measures (MMRM|||||0.07|-0.26|0.262
73923384|NCT01592344|147376065|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0048
73923385|NCT01592344|147376066|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73967935|NCT04169373|147473748|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.46|-0.18|||ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.18|-0.46|<0.0001
73923386|NCT01592344|147376067|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73967936|NCT04169373|147473749|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.9|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.9|-2.0|<0.0001
73967937|NCT04169373|147473750|OTHER||LS Mean Difference|-3.31|||<|0.0001|TWO_SIDED|95.0|-4.5|-2.12||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.12|-4.50|<0.0001
73923387|NCT01592344|147376068|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73923388|NCT00944450|147376150|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence bounds = (0.80, 1.25) for AUC geometric mean ratio (B/A)|Geometric Mean Ratio|1.05||||||90.0|1.02|1.07||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)||1.07|1.02|
73923389|NCT00944450|147376151|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence bounds = (0.80, 1.25) for Cmax geometric mean ratio (B/A)|Geometric Mean Ratio|1.07||||||90.0|0.94|1.22||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)||1.22|0.94|
73923390|NCT03011307|147376167|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference in score on a scale|0.1||||0.75|TWO_SIDED|95.0|0.0|0.2||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||.2|0|0.75
74086969|NCT03078478|147727904|SUPERIORITY||Treatment rate ratio|0.88||||0.1715|TWO_SIDED|95.0|0.73|1.06|||Regression, Cox|||The number of episodes is analysed using a negative binomial regression model (log link) with the logarithm of the time period in which a hypoglycaemic episode was considered treatment emergent as offset. The model includes treatment, number of OADs, region, sex and dosing time as fixed factors, and age as a covariate. Missing values are imputed through multiple imputation by treatment arm, based on a Poisson model.||1.06|0.73|0.1715
73923391|NCT03011307|147376168|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference|0.1||||0.057|TWO_SIDED|95.0|0.0|0.2||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||0.2|0.0|0.057
73923392|NCT03011307|147376169|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference in Daily Steps|-402.0||||0.41|TWO_SIDED|95.0|-1358.0|553.0||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||553|-1358|0.41
73923393|NCT03011307|147376170|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Mean Difference (Final Values)|344.0|||<|0.001|TWO_SIDED|95.0|173.0|515.0||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Slope Difference|||"The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.~The slope is the number of daily steps divided by the natural log of time in days."||515|173|<0.001
73923394|NCT03011307|147376171|SUPERIORITY|A likelihood-ratio test for change in World Health Organization Disability Assessment Score 2.0 value was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference: score on a scale|-5.9||||0.002|TWO_SIDED|95.0|-9.5|-2.3||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline World Health Organization Disability Assessment Score 2.0 value, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||-2.3|-9.5|0.002
73923395|NCT03011307|147376172|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference|1.5||||0.001|TWO_SIDED|95.0|0.6|2.4||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||2.4|0.6|0.001
73923396|NCT03011307|147376173|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Mean Difference (Final Values)|0.00035||||0.537|TWO_SIDED|95.0|-0.00085|0.0015||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Intercept difference: Opioid probability|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||.0015|-.00085|0.537
73967938|NCT04169373|147473751|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.85|-0.45|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.45|-0.85|<0.0001
73923397|NCT03011307|147376174|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference: Opioid probability|-0.166||||0.01|TWO_SIDED|95.0|-0.172|-0.16||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||-0.160|-0.172|0.010
73923398|NCT03011307|147376175|SUPERIORITY||Mean Difference (Net)|3.0|STANDARD_DEVIATION|14.0||0.55|TWO_SIDED||||||Regression, Linear|||Scores were compared statistically at baseline and 2 months between groups using a generalized linear model with time as a fixed factor.||||.55
73923399|NCT03011307|147376176|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.2||0.46|TWO_SIDED||||||Regression, Linear|||Groups were compared over time from baseline to 2 months using a generalized linear model with time as a fixed factor.||||0.46
73923400|NCT03011307|147376177|SUPERIORITY||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.84||0.38|TWO_SIDED||||||Regression, Linear|||Groups were compared between preoperative and 2 month postoperative sessions using linear regression with time as a fixed factor.||||0.38
73923401|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the geometric mean ratio (GMR) for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.71|0.9||||||Serotype 1: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.90|0.71|
73923402|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.78|0.93||||||Serotype 3: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.93|0.78|
73923403|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.71|0.93||||||Serotype 4: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.93|0.71|
73923404|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.74|0.94||||||Serotype 5: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.94|0.74|
73923405|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.66|0.88||||||Serotype 6A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.88|0.66|
73923406|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.73|0.95||||||Serotype 6B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.95|0.73|
73923407|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.86|||||TWO_SIDED|95.0|0.77|0.96||||||Serotype 7F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.96|0.77|
73923408|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.93|||||TWO_SIDED|95.0|0.82|1.05||||||Serotype 9V: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.05|0.82|
73923409|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.89|1.13||||||Serotype 14: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.13|0.89|
73923410|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.74|0.97||||||Serotype 18C: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.97|0.74|
73923411|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.71|0.9||||||Serotype 19A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.90|0.71|
73923412|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.7|0.91||||||Serotype 19F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.91|0.70|
73923413|NCT03760146|147376242|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.7|0.97||||||Serotype 23F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.97|0.70|
73923414|NCT03760146|147376243|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.55|||||TWO_SIDED|95.0|0.49|0.62||||||Serotype 8: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.62|0.49|
73923415|NCT03760146|147376243|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.86|||||TWO_SIDED|95.0|1.63|2.12||||||Serotype 10A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.12|1.63|
73923416|NCT03760146|147376243|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.75|||||TWO_SIDED|95.0|1.52|2.01||||||Serotype 11A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.01|1.52|
73923417|NCT03760146|147376243|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.27|1.72||||||Serotype 12F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.72|1.27|
74086970|NCT02339090|147727924|NON_INFERIORITY|Threshold for significance: annualized height velocity between somavaratan and daily rhGH ≤ -2.0 cm/year|LS Mean Difference|-1.28|||||TWO_SIDED|95.0|-2.32|-0.24||||||An ANCOVA model will be used to determine the adjusted (least squares) means and standard error (SE) to determine the confidence interval (CI) of the difference. ANCOVA model included treatment group, region, and gender as fixed effects; with baseline age and baseline IGF-I SDS as covariates.||-0.24|-2.32|
74086971|NCT00749411|147727964|NON_INFERIORITY|GSK233705/GW642444 were declared non-inferior to placebo for heart rate if the upper limit of the 95% confidence interval for the estimated treatment difference for weighted mean heart rate was less than +10bpm.|Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-5.5|3.5|||||Analysis performed using a Repeated Measures Model with covariates of baseline pulse rate, sex, age, smoking status, treatment and Day and Day by treatment and Day by baseline interactions.|||3.5|-5.5|
74086972|NCT04052698|147727970|NON_INFERIORITY|1-sided test where the mean ratio is less than 0.5 utilizing a negative binomial counting regression model. One-sided alpha level of 2.5%.|Mean Difference (Final Values)|0.1645|||<|0.0001|TWO_SIDED|95.0|0.10194|0.26558|||Regression, Linear|||||0.26558|0.10194|<0.0001
73923418|NCT03760146|147376243|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.12|||||TWO_SIDED|95.0|2.62|3.71||||||Serotype 15B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||3.71|2.62|
73923419|NCT03760146|147376243|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.99|||||TWO_SIDED|95.0|1.7|2.32||||||Serotype 22F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.32|1.70|
73923420|NCT03760146|147376243|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.38|||||TWO_SIDED|95.0|1.21|1.57||||||Serotype 33F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.57|1.21|
73923421|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.26||||||Serotype 1: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.26|0.84|
73923422|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.06|||||TWO_SIDED|95.0|0.92|1.22||||||Serotype 3: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.22|0.92|
73923423|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.1|||||TWO_SIDED|95.0|0.87|1.38||||||Serotype 4: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.38|0.87|
73923424|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||Serotype 5: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.07|0.72|
73923425|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.21|||||TWO_SIDED|95.0|0.95|1.53||||||Serotype 6A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.53|0.95|
74086973|NCT04052698|147727972|NON_INFERIORITY|1-sided test where the mean ratio is less than 0.5 utilizing a negative binomial counting regression model. One-sided alpha level of 2.5%.|Mean Difference (Final Values)|0.1389|||<|0.0001|TWO_SIDED|95.0|0.07664|0.25187|||Regression, Linear|||||0.25187|0.07664|<0.0001
74086974|NCT02756637|147727984|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.98|1.11||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.||1.11|0.98|
74086975|NCT02756637|147727984|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.9|1.14||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.||1.14|0.90|
74086976|NCT04034355|147727985|SUPERIORITY||Risk Ratio (RR)|1.521||||0.028|TWO_SIDED|95.0|1.0462|2.2113|||Cochran-Mantel-Haenszel|||||2.2113|1.0462|0.0280
73923426|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.25|||||TWO_SIDED|95.0|1.0|1.56||||||Serotype 6B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|1.00|
73923427|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.89|||||TWO_SIDED|95.0|0.74|1.07||||||Serotype 7F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.07|0.74|
73923428|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.83|1.26||||||Serotype 9V: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.26|0.83|
73923429|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.25|||||TWO_SIDED|95.0|1.01|1.54||||||Serotype 14: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.54|1.01|
73923430|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.33|||||TWO_SIDED|95.0|1.06|1.68||||||Serotype 18C: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.68|1.06|
74086977|NCT03581188|147728008|SUPERIORITY||Odds Ratio (OR)|3.5|||||TWO_SIDED|95.0|0.9|14.0||||||Odds ratios report differences between groups at follow-up.||14|0.9|
74086978|NCT03581188|147728009|SUPERIORITY||Odds Ratio (OR)|2.2|||||TWO_SIDED|95.0|0.8|5.7||||||||5.7|0.8|
73923431|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||Serotype 19A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.25|0.85|
73923432|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.8|1.22||||||Serotype 19F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.22|0.80|
73923433|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.68|||||TWO_SIDED|95.0|1.27|2.22||||||Serotype 23F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.22|1.27|
73923434|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.97|||||TWO_SIDED|95.0|0.78|1.2||||||Serotype 8: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.20|0.78|
73923435|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.28||||||Serotype 10A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.28|0.84|
73923436|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.22|||||TWO_SIDED|95.0|0.96|1.56||||||Serotype 11A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|0.96|
73923437|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.11|||||TWO_SIDED|95.0|0.88|1.39||||||Serotype 12F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.39|0.88|
73923438|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.17|||||TWO_SIDED|95.0|0.88|1.56||||||Serotype 15B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|0.88|
73923439|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||Serotype 22F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.17|0.69|
73923440|NCT03760146|147376244|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.81|1.3||||||Serotype 33F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.30|0.81|
73923441|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.23|||||TWO_SIDED|95.0|1.01|1.5||||||Serotype 1: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.50|1.01|
73967939|NCT04169373|147473752|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.06|||<|0.0001|TWO_SIDED|95.0|-4.08|-2.04|||ANCOVA|ANCOVA model including treatment, main stratification factor, treatment and stratification factor interaction and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.04|-4.08|<0.0001
74028487|NCT02940886|147610647|SUPERIORITY||Mean Difference (Final Values)|41.7|||<|0.0001|TWO_SIDED|95.0|25.6|57.8|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||57.8|25.6|<0.0001
73967940|NCT04169373|147473753|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|20.1||||0.0001|TWO_SIDED|95.0|10.1|30.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.1|10.1|0.0001
74086979|NCT03581188|147728011|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|1.1|2.1||||||||2.1|1.1|
73923442|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.87|1.16||||||Serotype 3: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.16|0.87|
73923443|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.31|||||TWO_SIDED|95.0|2.65|4.13||||||Serotype 4: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.13|2.65|
73923444|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||Serotype 5: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.36|0.91|
73923445|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.84|||||TWO_SIDED|95.0|3.06|4.83||||||Serotype 6A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.83|3.06|
74086980|NCT03581188|147728012|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.6|2.0||||||||2|0.6|
74086981|NCT03581188|147728013|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|-2.0|23.0||||||For new melanoma diagnoses, we calculated the difference in proportions and confidence intervals using the χ2 method without continuity correction. We included baseline measurement of the outcome in the models as a covariate to estimate between group difference in change from baseline.||23|-2|
74086982|NCT03581188|147728014|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|2.0|19.0||||||New melanoma diagnoses prompted at unscheduled visit||19|2|
73923446|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.41|||||TWO_SIDED|95.0|2.73|4.26||||||Serotype 6B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.26|2.73|
73923447|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.58|||||TWO_SIDED|95.0|1.3|1.91||||||Serotype 7F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.91|1.30|
73923448|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.5|||||TWO_SIDED|95.0|2.83|4.33||||||Serotype 9V: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.33|2.83|
73923449|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.39|||||TWO_SIDED|95.0|1.93|2.96||||||Serotype 14: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.96|1.93|
73923450|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.2|||||TWO_SIDED|95.0|2.53|4.04||||||Serotype 18C: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.04|2.53|
73923451|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.31|||||TWO_SIDED|95.0|1.91|2.81||||||Serotype 19A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.81|1.91|
73923452|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.17|||||TWO_SIDED|95.0|1.76|2.68||||||Serotype 19F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.68|1.76|
73923453|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|4.8|||||TWO_SIDED|95.0|3.65|6.32||||||Serotype 23F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||6.32|3.65|
73923454|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.71|||||TWO_SIDED|95.0|1.38|2.12||||||Serotype 8: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.12|1.38|
73923455|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.62|||||TWO_SIDED|95.0|1.31|2.0||||||Serotype 10A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.00|1.31|
73923456|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.04|1.68||||||Serotype 11A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.68|1.04|
74086983|NCT03581188|147728014|SUPERIORITY||Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|-9.0|10.0||||||New melanoma diagnoses prompted at scheduled visit||10|-9|
74086984|NCT03581188|147728015|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-5.8|3.0||||||||3|-5.8|
74086985|NCT03535857|147728016|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.546|TWO_SIDED|95.0|||||Pairwise t- test|||||||0.546
74086986|NCT02190279|147728026|OTHER|||||||0.0033|||||||ANOVA|||At 1 hour post injection.||||0.0033
73923457|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.91|||||TWO_SIDED|95.0|1.51|2.41||||||Serotype 12F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.41|1.51|
73923458|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.52|||||TWO_SIDED|95.0|1.13|2.05||||||Serotype 15B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.05|1.13|
73923459|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.69|||||TWO_SIDED|95.0|1.3|2.2||||||Serotype 22F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.20|1.30|
73923460|NCT03760146|147376245|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.4|||||TWO_SIDED|95.0|1.1|1.79||||||Serotype 33F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.79|1.10|
73923461|NCT00449644|147376255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.77||||0.0034|TWO_SIDED|95.0|2.26|61.23|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||61.23|2.26|0.0034
73923462|NCT00449644|147376256|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.44|||<|0.0001|TWO_SIDED|95.0|1.57|3.8|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||3.80|1.57|<0.0001
74086987|NCT02190279|147728026|OTHER|||||||0.012|||||||ANOVA|||At 2 hour post injection.||||0.012
74086988|NCT02190279|147728027|EQUIVALENCE|One way analysis variance.|||||<|0.05|||||||variance|||||||<0.05
74086989|NCT04403399|147728050|SUPERIORITY||Mean Difference (Final Values)|-3.62||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.003
73923463|NCT00449644|147376257|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.14||||0.0022|TWO_SIDED|95.0|1.51|6.53|||Cox-proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||6.53|1.51|0.0022
73923464|NCT00449644|147376258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.029|TWO_SIDED|95.0|1.05|2.59|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||MGIT negative (Responders)||2.59|1.05|0.0290
73923465|NCT00449644|147376259|SUPERIORITY_OR_OTHER||Risk Difference (RD)|38.9|STANDARD_ERROR_OF_MEAN|12.38||0.003|TWO_SIDED|95.0|13.97|63.88|||Regression, Logistic|Treatment as covariate||Week 8||63.88|13.97|0.003
73923466|NCT00449644|147376259|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.7|STANDARD_ERROR_OF_MEAN|13.12||0.237|TWO_SIDED|95.0|-10.7|42.17|||Regression, Logistic|Treatment as covariate||Week 24||42.17|-10.70|0.237
73923467|NCT00449644|147376259|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.9|STANDARD_ERROR_OF_MEAN|15.02||0.5564|TWO_SIDED|95.0|-21.37|39.18|||Regression, Logistic|Treatment as covariate||Week 104 (Stage 1 Trial End)||39.18|-21.37|0.5564
73923468|NCT00449644|147376260|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.2|STANDARD_ERROR_OF_MEAN|7.9||0.008|TWO_SIDED|95.0|5.59|36.83|||Regression, Logistic|Treatment as covariate||Week 24||36.83|5.59|0.008
73923469|NCT00449644|147376260|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|STANDARD_ERROR_OF_MEAN|8.27||0.069|TWO_SIDED|95.0|-1.21|31.51|||Regression, Logistic|Treatment as covariate||Week 72||31.51|-1.21|0.069
73923470|NCT00449644|147376260|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.2|STANDARD_ERROR_OF_MEAN|8.54||0.035|TWO_SIDED|95.0|1.28|35.08|||Regression, Logistic|Treatment as covariate||Week 120||35.08|1.28|0.035
73923471|NCT01082965|147376261|SUPERIORITY_OR_OTHER||Leasts Square (LS) Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.265||0.9742|TWO_SIDED|95.0|-0.6|0.58||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Mixed model for repeated measures (MMRM) was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, Apolipoprotein E (ApoE) genotype, site as covariates.||0.58|-0.60|0.9742
73923472|NCT01082965|147376262|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.232||0.9638|TWO_SIDED|95.0|-0.51|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.49|-0.51|0.9638
73923473|NCT01082965|147376263|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.153||0.2548|TWO_SIDED|95.0|-0.53|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.16|-0.53|0.2548
73923474|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.057||0.6316|TWO_SIDED|95.0|-0.18|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.12|-0.18|0.6316
73923475|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.063||0.6256|TWO_SIDED|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.12|0.6256
73923476|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.059||0.5847|TWO_SIDED|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.12|0.5847
74086990|NCT04403399|147728051|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
74086991|NCT04403399|147728052|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.03|TWO_SIDED||||||Mixed Models Analysis|||||||0.03
73923477|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.123||0.1555|TWO_SIDED|95.0|-0.46|0.09||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.09|-0.46|0.1555
73923478|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.151||0.2416|TWO_SIDED|95.0|-0.51|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.51|0.2416
74086992|NCT00546910|147728069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.001|TWO_SIDED|95.0|0.52|0.87||P-value is for Time Active overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Time Active was tested at rank 8.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.87|0.52|<0.001
73923479|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.134||0.807|TWO_SIDED|95.0|-0.33|0.26||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.26|-0.33|0.8070
73923480|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.189||0.6828|TWO_SIDED|95.0|-0.59|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.43|-0.59|0.6828
73923481|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.109||0.8987|TWO_SIDED|95.0|-0.26|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.29|-0.26|0.8987
74086993|NCT00546910|147728069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|||<|0.001|TWO_SIDED|95.0|0.98|1.57||P-value is for Distance overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Distance was tested at rank 5.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.57|0.98|<0.001
73923482|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.117||0.8922|TWO_SIDED|95.0|-0.28|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.25|-0.28|0.8922
73923483|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.203||0.7555|TWO_SIDED|95.0|-0.39|0.52||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.52|-0.39|0.7555
73923484|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.218||0.1928|TWO_SIDED|95.0|-0.18|0.79||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.79|-0.18|0.1928
73923485|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.161||0.4946|TWO_SIDED|95.0|-0.26|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.49|-0.26|0.4946
73923486|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.196||0.7029|TWO_SIDED|95.0|-0.56|0.4||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.40|-0.56|0.7029
73923487|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.171||0.1085|TWO_SIDED|95.0|-0.68|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.68|0.1085
73923488|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.132||0.3588|TWO_SIDED|95.0|-0.44|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.18|-0.44|0.3588
73923489|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.151||0.3053|TWO_SIDED|95.0|-0.2|0.53||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.53|-0.20|0.3053
73923490|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.9861|TWO_SIDED|95.0|-0.36|0.36||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.36|-0.36|0.9861
73923491|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6558|TWO_SIDED|95.0|-0.41|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.28|-0.41|0.6558
73923492|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.145||0.9471|TWO_SIDED|95.0|-0.53|0.51||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.51|-0.53|0.9471
73923493|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.186||0.2136|TWO_SIDED|95.0|-0.77|0.23||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.23|-0.77|0.2136
73923494|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.189||0.6435|TWO_SIDED|95.0|-0.47|0.67||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.67|-0.47|0.6435
73923495|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.086||0.0659|TWO_SIDED|95.0|-0.41|0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.02|-0.41|0.0659
73923496|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.7687|TWO_SIDED|95.0|-0.41|0.31||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.31|-0.41|0.7687
73967941|NCT04169373|147473753|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.6|4.2|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.2|1.6|
73967942|NCT04169373|147473754|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|8.8||||0.0063|TWO_SIDED|95.0|2.5|15.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||15.2|2.5|0.0063
73967943|NCT04169373|147473754|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|1.3|7.0|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||7.0|1.3|
74028488|NCT02940886|147610647|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.115|TWO_SIDED|95.0|-20.3|2.2|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.2|-20.3|0.1150
74028489|NCT02940886|147610647|SUPERIORITY||Mean Difference (Final Values)|-8.3||||0.0812|TWO_SIDED|95.0|-17.7|1.0|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.0|-17.7|0.0812
73923497|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.163||0.1061|TWO_SIDED|95.0|-0.73|0.1||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.10|-0.73|0.1061
73923498|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.124||0.3925|TWO_SIDED|95.0|-0.41|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.41|0.3925
73923499|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.161||0.1991|TWO_SIDED|95.0|-0.58|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.58|0.1991
73923500|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.151||0.5176|TWO_SIDED|95.0|-0.45|0.24||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.24|-0.45|0.5176
73923501|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.143||0.314|TWO_SIDED|95.0|-0.5|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.18|-0.50|0.3140
73923502|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.171||0.6348|TWO_SIDED|95.0|-0.46|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.29|-0.46|0.6348
74086994|NCT00546910|147728069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.81|1.35||P-value is for Area overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Area was tested at rank 6.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.35|0.81|<0.001
73923503|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.165||0.1491|TWO_SIDED|95.0|-0.64|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.12|-0.64|0.1491
73923504|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.192||0.4226|TWO_SIDED|95.0|-0.59|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.27|-0.59|0.4226
73967944|NCT04169373|147473755|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.92||||0.0004|TWO_SIDED|95.0|-1.42|-0.41|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.41|-1.42|0.0004
74028490|NCT02940886|147610648|SUPERIORITY||Mean Difference (Final Values)|11.4|||<|0.0001|TWO_SIDED|95.0|10.1|12.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||12.7|10.1|<0.0001
73923505|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.228||0.9778|TWO_SIDED|95.0|-0.49|0.5||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.50|-0.49|0.9778
73923506|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.179||0.9456|TWO_SIDED|95.0|-0.4|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.43|-0.40|0.9456
73923507|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.162||0.2299|TWO_SIDED|95.0|-0.55|0.15||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.15|-0.55|0.2299
74086995|NCT00546910|147728069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.78|1.22||P-value is for Microevents overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Microevents was tested at rank 3.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.22|0.78|<0.001
74086996|NCT00546910|147728069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|||<|0.001|TWO_SIDED|95.0|0.18|0.58||P-value is for Motion Simplicity overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Motion Simplicity was tested at rank 9.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.58|0.18|<0.001
73923508|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.188||0.5069|TWO_SIDED|95.0|-0.54|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.28|-0.54|0.5069
73923509|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.143||0.3524|TWO_SIDED|95.0|-0.45|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.17|-0.45|0.3524
73923510|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.358||0.4182|TWO_SIDED|95.0|-0.8|1.47||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||1.47|-0.80|0.4182
73923511|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_DEVIATION|0.326||0.363|TWO_SIDED|95.0|-0.42|1.04||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||1.04|-0.42|0.3630
73923512|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.263||0.9837|TWO_SIDED|95.0|-0.73|0.74||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.74|-0.73|0.9837
73923513|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.102||0.0974|TWO_SIDED|95.0|-0.04|0.42||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.42|-0.04|0.0974
73923514|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.067||0.1246|TWO_SIDED|95.0|-0.04|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.27|-0.04|0.1246
73923515|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.119||0.619|TWO_SIDED|95.0|-0.2|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.20|0.6190
73923516|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.635|TWO_SIDED|95.0|-0.39|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.25|-0.39|0.6350
73923517|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.164||0.8205|TWO_SIDED|95.0|-0.4|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.40|0.8205
74086997|NCT00546910|147728070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.6|||<|0.001|TWO_SIDED|95.0|8.2|14.99||P-value for ADHD-RS Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)||14.99|8.20|<0.001
73923518|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.123||0.2959|TWO_SIDED|95.0|-0.42|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.42|0.2959
73923519|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.194||0.552|TWO_SIDED|95.0|-0.56|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.56|0.5520
73923520|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.22||0.9046|TWO_SIDED|95.0|-0.5|0.45||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.45|-0.50|0.9046
73923521|NCT01082965|147376264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.125||0.0402|TWO_SIDED|95.0|-0.62|-0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||-0.02|-0.62|0.0402
73923522|NCT01082965|147376265|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|12.11||0.688|TWO_SIDED|95.0|-21.82|31.82||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||31.82|-21.82|0.6880
73923523|NCT01082965|147376265|SUPERIORITY_OR_OTHER||LS Mean Difference|9.79|STANDARD_ERROR_OF_MEAN|9.143||0.3157|TWO_SIDED|95.0|-11.3|30.87||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||30.87|-11.30|0.3157
73923524|NCT01082965|147376265|SUPERIORITY_OR_OTHER||LS Mean Difference|9.86|STANDARD_ERROR_OF_MEAN|8.921||0.3228|TWO_SIDED|95.0|-13.56|33.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||33.28|-13.56|0.3228
73923525|NCT01082965|147376266|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.39|STANDARD_ERROR_OF_MEAN|3.479||0.254|TWO_SIDED|95.0|-12.9|4.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total IR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||4.12|-12.90|0.2540
73923526|NCT01082965|147376266|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.95||0.7684|TWO_SIDED|95.0|-4.17|5.37||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total DR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||5.37|-4.17|0.7684
73923527|NCT01082965|147376267|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.059||0.494|TWO_SIDED|95.0|-0.09|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.17|-0.09|0.4940
73923528|NCT01082965|147376267|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.057||0.1031|TWO_SIDED|95.0|-0.02|0.22||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.22|-0.02|0.1031
73923529|NCT01082965|147376267|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.048||0.3277|TWO_SIDED|95.0|-0.06|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.16|-0.06|0.3277
73923530|NCT01082965|147376267|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.029||0.6585|TWO_SIDED|95.0|-0.05|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.05|0.6585
74086998|NCT00546910|147728071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.11|||<|0.001|TWO_SIDED|95.0|0.76|1.46||P-value for CGI-S ADHD score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)||1.46|0.76|<0.001
73923531|NCT01082965|147376267|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.8863|TWO_SIDED|95.0|-0.07|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.07|0.8863
73923532|NCT01082965|147376267|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.044||0.4388|TWO_SIDED|95.0|-0.06|0.13||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.13|-0.06|0.4388
73923533|NCT01559012|147376269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_DEVIATION|2.7||0.001|TWO_SIDED|95.0|1.05|3.32||A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01 and a beta \> 0.90.|Wilcoxon (Mann-Whitney)|Statistical signiﬁcance was assessed by the use of Mann-Whitney U test. P \< 0.05 was deﬁned as statistically signiﬁcant||This is an analysis between groups of intervention clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.||3.32|1.05|0.001
73967945|NCT04169373|147473756|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.12||||0.0001|TWO_SIDED|95.0|-1.68|-0.55|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.55|-1.68|0.0001
74086999|NCT00546910|147728072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.74|||<|0.001|TWO_SIDED|95.0|3.55|7.92||P-value for Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||7.92|3.55|<0.001
73861801|NCT01149486|147269404|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.37|||||TWO_SIDED|90.0|98.75|106.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.14|98.75|
73923534|NCT01559012|147376269|NON_INFERIORITY_OR_EQUIVALENCE|A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01|within patient variation|1.83|||<|0.02|TWO_SIDED|95.0|0.43|3.24|||Wilcoxon (Mann-Whitney)|||This is a within patient variation between clonidine and placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean +/- Standard Deviation (SD).||3.24|0.43|<0.02
73923535|NCT01559012|147376270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.009|TWO_SIDED|95.0|1.78|11.5|||Wilcoxon (Mann-Whitney)|||Analysis within groups clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||11.5|1.78|0.009
73923536|NCT01559012|147376270|NON_INFERIORITY_OR_EQUIVALENCE|A sample size modeling for crossover studies (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01|within patient variation|7.5|||<|0.01|TWO_SIDED|95.0|2.17|12.83|||Wilcoxon (Mann-Whitney)|||Analysis within-patient. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.||12.83|2.17|<0.01
73967946|NCT04169373|147473757|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|23.8|||<|0.0001|TWO_SIDED|95.0|14.2|33.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.4|14.2|<0.0001
73967947|NCT04169373|147473757|OTHER||Odds Ratio (OR)|3.2|||||TWO_SIDED|95.0|1.9|5.4|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||5.4|1.9|
73967948|NCT04169373|147473758|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|10.9||||0.0035|TWO_SIDED|95.0|3.6|18.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||18.3|3.6|0.0035
73923537|NCT01559012|147376271|SUPERIORITY_OR_OTHER||difference of percentage of positivity|0.3||||0|TWO_SIDED|95.0|0.04|0.47|||Wilcoxon (Mann-Whitney)|||"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"||0.47|0.04|0.000
73923538|NCT01559012|147376272|SUPERIORITY_OR_OTHER||mean values|0.8||||0.013|TWO_SIDED|95.0|0.13|1.57|||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||1.57|0.13|0.013
73923539|NCT01559012|147376273|SUPERIORITY_OR_OTHER||days off-therapy %|29.0||||0.051|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||||0.051
73923540|NCT01559012|147376274|SUPERIORITY_OR_OTHER||proportion|0.0||||0.0089|TWO_SIDED|95.0|||||Fisher Exact|||||||0.0089
73967949|NCT04169373|147473758|OTHER||Odds Ratio (OR)|2.7|||||TWO_SIDED|95.0|1.3|5.6|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||5.6|1.3|
73967950|NCT04169373|147473759|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.68|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.68|-1.60|<0.0001
73967951|NCT04169373|147473760|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-2.23|||<|0.0001|TWO_SIDED|95.0|-3.26|-1.21|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-1.21|-3.26|<0.0001
74087000|NCT00546910|147728072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.96||||0.001|TWO_SIDED|95.0|2.49|5.44||P-value for Evening subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||5.44|2.49|0.001
74087001|NCT00546910|147728072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|||<|0.002|TWO_SIDED|95.0|0.42|1.93||P-value for Morning subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.93|0.42|<0.002
73923541|NCT01559012|147376277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0||||0.01|TWO_SIDED|95.0|0.9|10.9|||Wilcoxon (Mann-Whitney)|||||10.9|0.9|0.01
73923542|NCT01559012|147376278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.055|TWO_SIDED|95.0|0.3|6.3|||Wilcoxon (Mann-Whitney)|||||6.3|0.3|0.055
73923543|NCT00853723|147376319|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.0005|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline by day 15 in all three arms.|Kruskal-Wallis|||||||<0.0005
73923544|NCT00853723|147376320|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups.|Kruskal-Wallis|The threshold for stasistical significance was p=0.05||||||<0.05
73923545|NCT00853723|147376321|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline at Day 60 and at Day 90 for the PTH group and at day 90 for the PTHrP 400 and PTHrP 600 groups .|Kruskal-Wallis|||||||<0.05
73923546|NCT00853723|147376322|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in PTHrP 400 and 600 groups.|Kruskal-Wallis|The threshold for stastistical significance was p=0.05||||||<0.05
73923547|NCT00853723|147376323|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in the PTHrP 400 group|Kruskal-Wallis|The threshold for stastistical significance was p=0.05||||||<0.05
73923548|NCT00853723|147376324|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical signifcance was p=0.05||||||>0.05
73923549|NCT00853723|147376325|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||>0.05
73923550|NCT00853723|147376326|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005|TWO_SIDED|||||The reported p-value corresponds to change from baseline at Day 15 and 30 in the PTHrP 400 group and at Day 15 in the PTHrP 600 group|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05||||||<0.0005
73923551|NCT00853723|147376327|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds to PTH group on Day 60 compared to the PTHrP 400|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05||||||<0.05
73923552|NCT00853723|147376327|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the PTH group on Day 30 compared to the PTHrP 400 group and Day 60 compared to the PTHRp 600 group|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.005
73967952|NCT04169373|147473761|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.78|||<|0.0001|TWO_SIDED|95.0|-2.56|-1.0|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-1.00|-2.56|<0.0001
73967953|NCT04169373|147473762|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|22.8|||<|0.0001|TWO_SIDED|95.0|12.2|33.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.4|12.2|<0.0001
74087002|NCT00546910|147728072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|||<|0.001|TWO_SIDED|95.0|0.31|0.93||P-value for Item 11 (difficulty falling asleep).|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.93|0.31|<0.001
73923553|NCT00853723|147376327|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005|TWO_SIDED|||||The reported p-value correspond to the PTH group on Day 15 compared to the PTHrP 400 group and Day 15 and 30 compared to the PTHrP 600 group.|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.0005
73923554|NCT00853723|147376328|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the increase from baseline to D90 in the PTHrP 400 group.|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05||||||<0.005
73923555|NCT00853723|147376329|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p value corresponds to an increased from baseline at all time points in all Arms/groups as well as to the increase in the in the PTHrP 400 group at Day 60 and 90 compared to the PTHrP 600 and PTH groups .|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05||||||<0.05
73923556|NCT00853723|147376329|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the comparison of the PTHrP 400 group at Day 15 to the PTHrP 600 and PTH groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.005
73923557|NCT00853723|147376330|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds to an increase compared to baseline in the PTHrP 600 group at D15 and D30|F-test, one way analysis of variance|The threshold for stastistical significance was p=0.05||||||<0.05
73923558|NCT00853723|147376330|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.005|TWO_SIDED|||||the reported p-value corresponds to change from baseline in the PTHrP 400 group at Day 15,30, 60 and 90 and the PTH group at day 90.|Kruskal-Wallis|the threshold for statistical significance was p=0.05||||||<0.005
73923559|NCT00853723|147376331|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds the PTH group on Day 15 compared to the PTHrP 400 group and to the PTHrP 600 group at Day 30 and Day 60|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.05
73923560|NCT00853723|147376331|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.0005|TWO_SIDED|||||Thre reported p-value correspond to the PTH group compared to the PTHrp 600 group at day 15|Kruskal-Wallis|the threshold for statistical significance was p=0.05||||||<0.0005
73923561|NCT03479307|147376350|SUPERIORITY||Mean Difference (Final Values)|-0.71|||<|0.0001|TWO_SIDED|95.0|-1.013|-0.407|||ANCOVA|||Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 4b (including all time points).||-0.407|-1.013|< 0.0001
73923562|NCT03479307|147376350|SUPERIORITY||Mean Difference (Final Values)|-1.167|||<|0.0001|TWO_SIDED|95.0|-1.439|-0.895|||ANCOVA|||Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).||-0.895|-1.439|< 0.0001
73923563|NCT03479307|147376350|SUPERIORITY||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.413|-0.868|||ANCOVA|||Treatment Difference (95% CI): Ketotifen Ophthalmic Solution 0.025% (Zaditen) arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).||-0.868|-1.413|< 0.0001
73923564|NCT03479307|147376350|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|0.009||||0.0007|ONE_SIDED|97.5||0.235|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 3 minutes Post-CAC (non-inferiority test).||0.235||0.0007
73923565|NCT03479307|147376350|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|-0.077||||0.0002|ONE_SIDED|97.5||0.175|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 5 minutes Post-CAC (non-inferiority test).||0.175||0.0002
73967954|NCT04169373|147473762|OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|1.6|4.0|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.0|1.6|
73923566|NCT03479307|147376350|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|-0.159|||<|0.0001|ONE_SIDED|97.5||0.101|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 7 minutes Post-CAC (non-inferiority test).||0.101||< 0.0001
73923567|NCT01464346|147376351|SUPERIORITY_OR_OTHER||Intercept from ANCOVA as agreement rate|88.01|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED|95.0|85.69|90.33|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept||||90.33|85.69|<0.05
73923568|NCT01464346|147376352|SUPERIORITY_OR_OTHER||Intercept from ANCOVA as agreement rate|90.52|STANDARD_ERROR_OF_MEAN|0.9|<|0.05|TWO_SIDED|95.0|88.77|92.28|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept||||92.28|88.77|< 0.05
73923569|NCT02295995|147376359|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for physical activity in this sample was 1.37|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
73923570|NCT02295995|147376360|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for PCL-5 in this sample was 0.38|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
73923571|NCT02295995|147376361|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for 6-minute walk in this sample was 0.50|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
73923572|NCT01787175|147376373|SUPERIORITY_OR_OTHER||Difference in time to complete A&P|-17.73||||0.047|TWO_SIDED|95.0|-35.24|-0.23|||Mixed-effects linear model|||Null hypothesis: Participants will require the same amount of time to complete assessments and plans using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||-0.23|-35.24|0.047
73923573|NCT01787175|147376374|SUPERIORITY_OR_OTHER||Value of problem scores for A&P complete|0.04||||0.15|TWO_SIDED|95.0|-0.01|0.09|||Mixed-effects linear model|||Null hypothesis: Participants will receive the same scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||0.09|-0.01|0.15
73923574|NCT01787175|147376375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.005|TWO_SIDED|95.0|1.22|2.98|||Regression, Logistic|||Null hypothesis: Participants will receive the same proportion of acceptable scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||2.98|1.22|0.005
73923575|NCT04350788|147376391|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for patient.||||0.02
73923576|NCT04350788|147376391|SUPERIORITY|||||||0.25|||||||t-test, 1 sided|||We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for partner.||||0.25
73923577|NCT04350788|147376392|SUPERIORITY|||||||0.36|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in general domain.||||0.36
73923578|NCT04350788|147376392|SUPERIORITY|||||||0.38|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in content domain.||||0.38
73923579|NCT04350788|147376392|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in navigation domain.||||0.02
73923580|NCT04350788|147376392|SUPERIORITY|||||||0.62|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in general domain.||||0.62
73923581|NCT04350788|147376392|SUPERIORITY|||||||0.65|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in content domain.||||0.65
73923582|NCT04350788|147376392|SUPERIORITY|||||||0.45|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in navigation domain.||||0.45
73923583|NCT04350788|147376393|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||0.35
73923584|NCT04350788|147376394|SUPERIORITY|||||||0.01|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in urinary domain.||||0.01
73923585|NCT04350788|147376394|SUPERIORITY|||||||0.41|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in bowel domain.||||0.41
73923586|NCT04350788|147376394|SUPERIORITY|||||||0.21|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in sexual domain.||||0.21
73923587|NCT04350788|147376394|SUPERIORITY|||||||0.52|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in hormonal domain.||||0.52
73923588|NCT04350788|147376394|SUPERIORITY|||||||0.79|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in urinary domain.||||0.79
73923589|NCT04350788|147376394|SUPERIORITY|||||||0.84|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in bowel domain.||||0.84
73923590|NCT04350788|147376394|SUPERIORITY|||||||0.82|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in sexual domain.||||0.82
73923591|NCT04350788|147376394|SUPERIORITY|||||||0.33|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in hormonal domain.||||0.33
73923592|NCT04350788|147376395|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
73923593|NCT04350788|147376395|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
73923594|NCT04350788|147376396|SUPERIORITY|||||||0.05|||||||generalized linear regression|||||||0.05
73923595|NCT04350788|147376397|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.10
73923596|NCT04350788|147376398|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
73923597|NCT04350788|147376399|SUPERIORITY|||||||0.49|||||||Mixed Models Analysis|||||||0.49
73923598|NCT04350788|147376400|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
73923599|NCT04350788|147376401|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
73923600|NCT04350788|147376402|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.55
73923601|NCT02255981|147376411|OTHER|Non-inferiority could be considered if the outcomes were comparable to the most known studies yet published or, in the case of non-treatable disorder, if the acupuncture treatment got to maintain the VA and prevent the losses. There are many known studies with conventional treatment and estimations of the worsening of vision in this pathologies on the time without treatment.|Mean Difference (Final Values)|15.392|||<|0.05|TWO_SIDED|95.0||||"Using the SPSS program and the non-parametrical technic of Wilcoxon it was determined the p-value.~It should be noted that the null hypothesis is that all these eyes should have a zero gain or perhaps a loss in VA at two years of follow-up."|t-test, 1 sided|From this estimation, it is induced that there are differences in results before and after the treatment.|The datum corresponds to the difference in letters seen between exams at the start and the final examination for all participants. Calculi were made by a Microsoft Excel Descriptive Statistics program.|"Besides that it is of interest to compare with the published studies outcomes, realized with anti-VEGF treatments, and with the known expectations of AV lost without treatment, the data were converted in letters ETDRS chart and here are registered the mean number of letters gained or lost in each group.~Ho: Differences between mean measurements before and after are similar H1: Differences between mean measurements before and after are different."|The null hypothesis was no gain or loss in VA. The alternative hypothesis was stabilization or some gain in letters seen over the baseline count.The published studies report a small gain in VA in about a third of participants and only in cases of NV-AMD with conventional treatment, and an expectancy of loss of vision in the other non treated or non-treatable macular diseases. Some of the participants in this trial had had ocular injections without positive change. Non-inferiority in this trial means outcomes of similar magnitude to the known studies.|||<0.05
74087003|NCT00546910|147728073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.66|1.35||P-value is for Reaction Time Variation overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Reaction time variation was tested at rank 1.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.35|0.66|<0.001
74087004|NCT00546910|147728073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||<|0.001|TWO_SIDED|95.0|0.46|0.93||P-value is for Omission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Omission error was tested at rank 7.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.93|0.46|<0.001
74087005|NCT00546910|147728073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|||<|0.001|TWO_SIDED|95.0|0.17|0.65||P-value is for Mean Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Mean reaction time was tested at rank 2.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.65|0.17|<0.001
74087006|NCT00546910|147728073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|0.26|0.73||P-value is for Normalized Variation of Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Normalized Variation of Reaction Time was tested at rank 10.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.73|0.26|<0.001
73923602|NCT01046682|147376423|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon rank sum test|||Using data from a different population, ie, patients with peripheral artery disease, and a different intervention, ie, omega-3 fatty acids, 15 participants were needed per group to achieve 80% power to detect a difference in means of -3.6% (the difference between the control group mean of -0.3% and a treatment group mean of 3.3%) assuming a common standard deviation of 3.3 using a two group t-test with a 0.05 two-sided significance level. 5 patients added to each arm in case nonparametric.||||<0.05
73923603|NCT02246673|147376448|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-28.18|||<|0.0001|TWO_SIDED|95.0|-33.85|-22.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||-22.51|-33.85|<0.0001
73967955|NCT04169373|147473763|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.1||||0.1781|TWO_SIDED|95.0|-0.25|0.05|||ANCOVA|ANCOVA model including treatment and main stratification factor MRI and hsCRP status as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||0.05|-0.25|0.1781
73967956|NCT04169373|147473764|OTHER||LS Mean Difference|-0.7||||0.0193|TWO_SIDED|95.0|-1.3|-0.1|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.1|-1.3|0.0193
73967957|NCT04169373|147473765|SUPERIORITY||Response Rate Difference|20.1||||0.0003|TWO_SIDED|95.0|9.3|30.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.9|9.3|0.0003
73923604|NCT02246673|147376448|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-25.29|||<|0.0001|TWO_SIDED|95.0|-31.23|-19.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||-19.34|-31.23|<0.0001
73923605|NCT02246673|147376448|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-29.15|||<|0.0001|TWO_SIDED|95.0|-33.15|-25.15|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||-25.15|-33.15|<0.0001
73923606|NCT02246673|147376448|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-22.25|||<|0.0001|TWO_SIDED|95.0|-26.36|-18.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||-18.14|-26.36|<0.0001
73967958|NCT04169373|147473766|OTHER||LS Mean Difference|-1.13||||0.0206|TWO_SIDED|95.0|-2.08|-0.17||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and main stratification factors MRI and hsCRP status as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.17|-2.08|0.0206
73923607|NCT02246673|147376448|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-17.52|||<|0.0001|TWO_SIDED|95.0|-21.54|-13.5|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||-13.50|-21.54|<0.0001
73923608|NCT02246673|147376448|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-15.51|||<|0.0001|TWO_SIDED|95.0|-19.53|-11.49|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||-11.49|-19.53|<0.0001
73923609|NCT02246673|147376448|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-9.74|||<|0.0001|TWO_SIDED|95.0|-13.97|-5.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||-5.51|-13.97|<0.0001
73923610|NCT02246673|147376448|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-4.98||||0.0221|TWO_SIDED|95.0|-9.19|-0.76|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4||-0.76|-9.19|0.0221
73923611|NCT02246673|147376448|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-35.38|||<|0.0001|TWO_SIDED|95.0|-38.89|-31.87|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-31.87|-38.89|<0.0001
73923612|NCT02246673|147376448|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-27.08|||<|0.0001|TWO_SIDED|95.0|-30.6|-23.57|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-23.57|-30.60|<0.0001
73923613|NCT02246673|147376448|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-31.26|||<|0.0001|TWO_SIDED|95.0|-34.77|-27.75|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-27.75|-34.77|<0.0001
73923614|NCT02246673|147376449|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|24.27||||0.0002|TWO_SIDED|95.0|12.57|35.98|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||35.98|12.57|0.0002
73923615|NCT02246673|147376449|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|20.08||||0.0013|TWO_SIDED|95.0|8.38|31.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||31.79|8.38|0.0013
73923616|NCT02246673|147376449|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|23.7|||<|0.0001|TWO_SIDED|95.0|14.23|33.17|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||33.17|14.23|<0.0001
73923617|NCT02246673|147376449|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|18.37||||0.0008|TWO_SIDED|95.0|8.3|28.44|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||28.44|8.30|0.0008
73923618|NCT02246673|147376449|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|18.82||||0.0101|TWO_SIDED|95.0|4.86|32.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||32.79|4.86|0.0101
73923619|NCT02246673|147376449|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|20.52||||0.0055|TWO_SIDED|95.0|6.56|34.48|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||34.48|6.56|0.0055
73923620|NCT02246673|147376449|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|10.36||||0.0065|TWO_SIDED|95.0|3.13|17.59|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||17.59|3.13|0.0065
73923621|NCT02246673|147376449|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|1.79||||0.614|TWO_SIDED|95.0|-5.37|8.94|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4||8.94|-5.37|0.6140
73967959|NCT04169373|147473768|SUPERIORITY||Response Rate Difference|17.6||||0.0004|TWO_SIDED|95.0|7.9|27.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||27.3|7.9|0.0004
73967960|NCT04169373|147473769|SUPERIORITY||Response Rate Difference|21.9|||<|0.0001|TWO_SIDED|95.0|13.2|30.6||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.6|13.2|<0.0001
73923622|NCT02246673|147376449|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|30.83||||0.0002|TWO_SIDED|95.0|15.62|46.04|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||46.04|15.62|0.0002
73923623|NCT02246673|147376449|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|24.38||||0.0019|TWO_SIDED|95.0|9.63|39.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||39.14|9.63|0.0019
73923624|NCT02246673|147376449|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|26.35||||0.0009|TWO_SIDED|95.0|11.59|41.11|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||41.11|11.59|0.0009
73923625|NCT02246673|147376450|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|139.11|||<|0.0001|TWO_SIDED|95.0|93.92|184.31|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||184.31|93.92|<0.0001
73923626|NCT02246673|147376450|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|174.47|||<|0.0001|TWO_SIDED|95.0|125.52|233.42|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||233.42|125.52|<0.0001
73923627|NCT02246673|147376450|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|168.03|||<|0.0001|TWO_SIDED|95.0|123.13|212.93|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||212.93|123.13|<0.0001
73923628|NCT02246673|147376450|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|188.75|||<|0.0001|TWO_SIDED|95.0|138.04|239.46|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||239.46|138.04|<0.0001
73861802|NCT01149486|147269405|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.3|||||TWO_SIDED|90.0|98.72|106.01|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.01|98.72|
73923629|NCT02246673|147376450|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|70.43||||0.0005|TWO_SIDED|95.0|33.74|107.12|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||107.12|33.74|0.0005
73861803|NCT01344629|147269470|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|100.9||||||90.0|97.7|104.2||No statistical test|ANOVA|||||104.2|97.7|
73923630|NCT02246673|147376450|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|91.5|||<|0.0001|TWO_SIDED|95.0|54.81|128.19|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||128.19|54.81|<0.0001
73923631|NCT02246673|147376450|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|40.11|||<|0.0001|TWO_SIDED|95.0|25.17|55.05|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||55.05|25.17|<0.0001
73923632|NCT02246673|147376450|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|15.96||||0.035|TWO_SIDED|95.0|1.2|30.71|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||30.71|1.20|0.0350
73923633|NCT02246673|147376450|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|236.08|||<|0.0001|TWO_SIDED|95.0|178.29|293.86|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||293.86|178.29|<0.0001
73967961|NCT04169373|147473770|SUPERIORITY||Response Rate Difference|23.1|||<|0.0001|TWO_SIDED|95.0|12.4|33.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.7|12.4|<0.0001
74087007|NCT00546910|147728074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|0.31|0.68||P-value is for Commission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Commission Error was tested at rank 4.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.68|0.31|<0.001
74087008|NCT00546910|147728074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.022|TWO_SIDED|95.0|0.02|0.31||P-value is for Anticipatory Response overall for morning, noon and evening. Anticipatory Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.31|0.02|0.022
73923634|NCT02246673|147376450|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|146.2|||<|0.0001|TWO_SIDED|95.0|90.4|202.01|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||202.01|90.40|<0.0001
73923635|NCT02246673|147376450|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|176.57|||<|0.0001|TWO_SIDED|95.0|120.77|232.38|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||232.38|120.77|<0.0001
73861804|NCT01344629|147269471|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|97.2||||||90.0|87.2|108.3||No statistical test|ANOVA|||||108.3|87.2|
73861805|NCT01344629|147269472|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|101.7||||||90.0|98.3|105.2||No statistical test|ANOVA|||||105.2|98.3|
73923636|NCT02246673|147376451|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|135.82|||<|0.0001|TWO_SIDED|95.0|93.33|178.32|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||178.32|93.33|<0.0001
73923637|NCT02246673|147376451|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|178.58|||<|0.0001|TWO_SIDED|95.0|129.25|227.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||227.90|129.25|<0.0001
73923638|NCT02246673|147376451|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|163.98|||<|0.0001|TWO_SIDED|95.0|120.8|207.16|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||207.16|120.80|<0.0001
73923639|NCT02246673|147376451|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|169.93|||<|0.0001|TWO_SIDED|95.0|122.82|217.03|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||217.03|122.82|<0.0001
73923640|NCT02246673|147376451|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|59.6||||0.0007|TWO_SIDED|95.0|28.85|90.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||90.34|28.85|0.0007
73923641|NCT02246673|147376451|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|73.54|||<|0.0001|TWO_SIDED|95.0|42.79|104.28|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||104.28|42.79|<0.0001
73923642|NCT02246673|147376451|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|33.7|||<|0.0001|TWO_SIDED|95.0|21.21|46.2|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||46.20|21.21|<0.0001
73967962|NCT02226276|147473771|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74087009|NCT00546910|147728075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.001|TWO_SIDED|95.0|0.69|1.18||P-value is for Error Rate overall for morning, noon and evening. Error Rate was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.18|0.69|<0.001
73923643|NCT02246673|147376451|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|27.08||||0.0001|TWO_SIDED|95.0|14.58|39.58|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||39.58|14.58|0.0001
73923644|NCT02246673|147376451|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|188.83|||<|0.0001|TWO_SIDED|95.0|152.55|225.1|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||225.10|152.55|<0.0001
73923645|NCT02246673|147376451|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|116.83|||<|0.0001|TWO_SIDED|95.0|81.76|151.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||151.90|81.76|<0.0001
73923646|NCT02246673|147376451|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|151.66|||<|0.0001|TWO_SIDED|95.0|116.59|186.73|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||186.73|116.59|<0.0001
73923647|NCT05413369|147376481|NON_INFERIORITY|The non-inferiority was assessed using the upper bound of the 2-sided 95% confidence interval (CI). Non-inferiority p-value was calculated from a non-inferiority margin of 0.3%.|Least Squares (LS) Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.33|-0.07|||ANCOVA|Treatment groups and randomization stratum of previous oral anti-diabetic drug(OADs) as fixed effects,and baseline HbA1c continuous value as covariate||Statistical analysis for change from baseline in HbA1c||-0.07|-0.33|<0.001
73923648|NCT05413369|147376482|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|97.5|-0.35|-0.05|||ANCOVA|Treatment groups and randomization stratum of previous as fixed effects, and baseline HbA1c continuous value as covariate||Statistical analysis for change from baseline in HbA1c||-0.05|-0.35|0.003
73923649|NCT05413369|147376483|SUPERIORITY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|97.5|-2.32|-0.66|||ANCOVA|Treatment groups, randomization stratums of HbA1c and previous OADs as fixed effects, and baseline body weight continuous value as covariate.||Statistical analysis for change from baseline in body weight||-0.66|-2.32|<0.001
73923650|NCT05413369|147376484|SUPERIORITY||Odds Ratio (OR)|1.89|||<|0.001|TWO_SIDED|97.5|1.25|2.85|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c||Statistical analysis for percentage of participants reaching HbA1c value \<7% at Week 24||2.85|1.25|<0.001
73967963|NCT02226276|147473772|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73967964|NCT03135548|147473773|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||TWO_SIDED|95.0|-0.19|0.338|||Wilson/Newcombe|95% confidence intervals (CI) are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.338|-0.190|
73967965|NCT03135548|147473773|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||TWO_SIDED|95.0|-0.19|0.338|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.338|-0.190|
73923651|NCT05413369|147376485|SUPERIORITY||Odds Ratio (OR)|2.59|||<|0.001|TWO_SIDED|95.0|1.79|3.76|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c and body weight.||Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24||3.76|1.79|<0.001
73923652|NCT05413369|147376486|SUPERIORITY||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.52|3.6|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c and body weight.||Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24 and no hypoglycemia during treatment||3.60|1.52|<0.001
73967966|NCT03135548|147473775|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.095|||||TWO_SIDED|95.0|-0.289|0.086|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.086|-0.289|
74028491|NCT02940886|147610648|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.0001|TWO_SIDED|95.0|1.2|3.6|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||3.6|1.2|0.0001
73923653|NCT00720057|147376500|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The treatment differences between the two groups were tested each at the 5% two-sided significant level using a hierarchal testing procedure to control the overall type 1 error. SPID16-24 was eligible for testing only after a statistically significant difference between the two arms with respect to SPID0-24 was observed. The SPIDs were analyzed via ANCOVA model with treatment and trial site as fixed effects and baseline pain intensity score as the covariate.||||<0.001
73923654|NCT00720057|147376501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73923655|NCT00720057|147376502|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73923656|NCT00720057|147376503|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||The statistics are from the Kaplan-Meier method. The median for naproxen treatment arm was not estimable from Kaplan-Meier method, therefore it is presented as the maximum value from the full range.||||<0.001
73923657|NCT00720057|147376504|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73923658|NCT00720057|147376505|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
73923659|NCT00189228|147376532|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||t-test, 2 sided|||This is not a drug study.||||<0.01
73967967|NCT03135548|147473775|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.115|||||TWO_SIDED|95.0|-0.116|0.348|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.348|-0.116|
73923660|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.8096|||<|0.0001|TWO_SIDED|95.0|15.0866|26.5327|||Mixed Models Analysis|Mixed-effect model was implemented with Restricted Maximum Likelihood (REML) estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95 percent (%) Confidence Interval (CI) were obtained from the model.||26.5327|15.0866|<0.0001
73923661|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4625|||<|0.0001|TWO_SIDED|95.0|18.7321|30.1929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.1929|18.7321|<0.0001
73923662|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5792||||0.8428|TWO_SIDED|95.0|-6.3385|5.18|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.1800|-6.3385|0.8428
73923663|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9993||||0.4957|TWO_SIDED|95.0|-7.7832|3.7845|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.7845|-7.7832|0.4957
73923664|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9683||||0.7431|TWO_SIDED|95.0|-4.8567|6.7932|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.7932|-4.8567|0.7431
73923665|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.3889|||<|0.0001|TWO_SIDED|95.0|-27.1044|-15.6734|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.6734|-27.1044|<0.0001
73923666|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.809|||<|0.0001|TWO_SIDED|95.0|-28.5584|-17.0596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.0596|-28.5584|<0.0001
73923667|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-19.8414|||<|0.0001|TWO_SIDED|95.0|-25.6435|-14.0393|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.0393|-25.6435|<0.0001
73923668|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0418|||<|0.0001|TWO_SIDED|95.0|-30.6705|-19.413|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.4130|-30.6705|<0.0001
73923669|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.4618|||<|0.0001|TWO_SIDED|95.0|-32.1455|-20.7782|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.7782|-32.1455|<0.0001
73923670|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4943|||<|0.0001|TWO_SIDED|95.0|-29.244|-17.7445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.7445|-29.2440|<0.0001
73923671|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4538||||0.572|TWO_SIDED|95.0|-6.5274|3.6198|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.6198|-6.5274|0.5720
73923672|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9938||||0.0006|TWO_SIDED|95.0|-14.0695|-3.918|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.9180|-14.0695|0.0006
73923673|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8686||||0.4704|TWO_SIDED|95.0|-3.2342|6.9713|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.9713|-3.2342|0.4704
73923674|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0725||||0.4255|TWO_SIDED|95.0|-3.0533|7.1984|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.1984|-3.0533|0.4255
73923675|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3425||||0.8959|TWO_SIDED|95.0|-5.5053|4.8204|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.8204|-5.5053|0.8959
73923676|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3224||||0.1967|TWO_SIDED|95.0|-1.7402|8.385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.3850|-1.7402|0.1967
73923677|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5264||||0.1733|TWO_SIDED|95.0|-1.5676|8.6203|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.6203|-1.5676|0.1733
73923678|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1113||||0.6697|TWO_SIDED|95.0|-4.0285|6.2512|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2512|-4.0285|0.6697
73923679|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8623|||<|0.0001|TWO_SIDED|95.0|5.8712|15.8535|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||15.8535|5.8712|<0.0001
73923680|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0663|||<|0.0001|TWO_SIDED|95.0|6.0281|16.1045|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.1045|6.0281|<0.0001
73923681|NCT00975481|147376545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6513||||0.001|TWO_SIDED|95.0|3.5552|13.7474|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||13.7474|3.5552|0.0010
73923682|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.6388|||<|0.0001|TWO_SIDED|95.0|10.5727|22.7049|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||22.7049|10.5727|<0.0001
73923683|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.8432|||<|0.0001|TWO_SIDED|95.0|13.7627|25.9238|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||25.9238|13.7627|<0.0001
73967968|NCT03135548|147473776|OTHER|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|7.24|||||TWO_SIDED|95.0|-20.01|34.48|||Student's t-distribution|CIs were based on Student's t-distribution.||||34.48|-20.01|
73967969|NCT03135548|147473776|OTHER|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-28.35|16.7|||Student's t-distribution|CIs were based on Student's t-distribution.||||16.70|-28.35|
73923684|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6121||||0.6029|TWO_SIDED|95.0|-7.7209|4.4967|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.4967|-7.7209|0.6029
74087010|NCT00546910|147728075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.178|TWO_SIDED|95.0|0.05|0.28||P-value is for Multi Response overall for morning, noon and evening. Multi Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.28|0.05|0.178
74087011|NCT03407612|147728076|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.67|||||||t-test, 2 sided|||This analysis considers the baseline HOS-ADL measures.||||0.67
74087012|NCT03407612|147728076|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.73|||||||t-test, 2 sided|||This analysis considers the 6 week postoperative HOS-ADL measures.||||0.73
73923685|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9241||||0.3477|TWO_SIDED|95.0|-9.0571|3.2089|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.2089|-9.0571|0.3477
73923686|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0908||||0.9769|TWO_SIDED|95.0|-6.085|6.2667|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2667|-6.0850|0.9769
73923687|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.2509|||<|0.0001|TWO_SIDED|95.0|-24.3155|-12.1864|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-12.1864|-24.3155|<0.0001
73923688|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5629|||<|0.0001|TWO_SIDED|95.0|-25.6616|-13.4642|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-13.4642|-25.6616|<0.0001
73923689|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.548|||<|0.0001|TWO_SIDED|95.0|-22.7036|-10.3923|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.3923|-22.7036|<0.0001
73923690|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4554|||<|0.0001|TWO_SIDED|95.0|-27.4199|-15.4908|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.4908|-27.4199|<0.0001
73923691|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7673|||<|0.0001|TWO_SIDED|95.0|-28.7925|-16.7422||Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Mixed Models Analysis|||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.7422|-28.7925|<0.0001
73967970|NCT03135548|147473777|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.143|||||TWO_SIDED|95.0|-0.346|0.049|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.||||0.049|-0.346|
73967971|NCT03135548|147473777|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.015|||||TWO_SIDED|95.0|-0.213|0.252|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.||||0.252|-0.213|
73967972|NCT04650087|147473786|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.44|1.95||||||||1.95|0.44|
73967973|NCT04650087|147473787|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.83|1.31||||||||1.31|0.83|
73967974|NCT04650087|147473788|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.78|1.24||||||||1.24|0.78|
73967975|NCT04650087|147473789|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.44|1.74||||||||1.74|0.44|
73967976|NCT04650087|147473790|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.58|2.12||||||||2.12|0.58|
73967977|NCT04650087|147473791|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.29|3.42||||||||3.42|0.29|
73967978|NCT04650087|147473792|SUPERIORITY||Risk Ratio (RR)|0.33|||||TWO_SIDED|95.0|0.03|3.18||||||||3.18|0.03|
73967979|NCT04650087|147473793|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.34|2.28||||||||2.28|0.34|
74087013|NCT03407612|147728076|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.87|||||||t-test, 2 sided|||This analysis considers the 12 week postoperative HOS-ADL measures.||||0.87
73923692|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.7524|||<|0.0001|TWO_SIDED|95.0|-25.8485|-13.6563|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-13.6563|-25.8485|<0.0001
73923693|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0888||||0.0006|TWO_SIDED|95.0|5.3225|18.8551|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.8551|5.3225|0.0006
73923694|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0768||||0.0038|TWO_SIDED|95.0|3.3132|16.8403|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.8403|3.3132|0.0038
73923695|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1875||||0.2257|TWO_SIDED|95.0|-10.989|2.6139|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.6139|-10.9890|0.2257
73923696|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8589||||0.8042|TWO_SIDED|95.0|-7.6927|5.975|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9750|-7.6927|0.8042
73923697|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6335||||0.6399|TWO_SIDED|95.0|-8.5177|5.2506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.2506|-8.5177|0.6399
73923698|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2763|||<|0.0001|TWO_SIDED|95.0|-23.0228|-9.5229|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.5229|-23.0228|<0.0001
73923699|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9477||||0.0002|TWO_SIDED|95.0|-19.7374|-6.158|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.1580|-19.7374|0.0002
73923700|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7223||||0.0001|TWO_SIDED|95.0|-20.572|-6.8727|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.8727|-20.5720|0.0001
73967980|NCT03519581|147473859|OTHER|The primary statistical analysis was an intention-to-treat analysis. The primary outcome was analyzed by Kruskal-Wallis test because the data was non-parametric.||||||0.76|||||||Kruskal-Wallis|||The target sample size for the study was 30 eyes, based on power calculations to achieve 80% power assuming 40% of sham-treated eyes will reach the vision loss threshold within 2 years, while SML treatment will reduce that value to 15%, using a 2:1 ratio for randomization (2 treatment : 1 sham).||||.76
73967981|NCT03519581|147473860|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||.16
73967982|NCT03519581|147473861|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
73967983|NCT03519581|147473862|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||.68
73967984|NCT03519581|147473863|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
73967985|NCT03519581|147473864|SUPERIORITY|Two-tailed t-tests and mixed effects regression models||||||0.5|||||||t-test, 2 sided|||||||.50
73967986|NCT04410042|147473886|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.4|||||||Wilcoxon rank sum test|||||||0.4000
73967987|NCT04410042|147473887|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.4286|||||||Wilcoxon rank sum test|||||||0.4286
73967988|NCT04410042|147473888|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.9307|||||||Wilcoxon rank sum test|||||||0.9307
73967989|NCT04410042|147473889|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.0714|||||||Wilcoxon rank sum test|||||||0.0714
73967990|NCT04410042|147473890|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.9004|||||||Wilcoxon rank sum test|||||||0.9004
73967991|NCT04640298|147473895|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
73967992|NCT04640298|147473896|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
73967993|NCT04640298|147473897|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
74087014|NCT03407612|147728076|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.78|||||||t-test, 2 sided|||This analysis considers the 6 month postoperative HOS-ADL measures.||||0.78
73923701|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2643|||<|0.0001|TWO_SIDED|95.0|-20.9226|-7.606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-7.6060|-20.9226|<0.0001
73923702|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9356||||0.0016|TWO_SIDED|95.0|-17.6548|-4.2165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.2165|-17.6548|0.0016
73923703|NCT00975481|147376546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7103||||0.0008|TWO_SIDED|95.0|-18.5055|-4.9151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.9151|-18.5055|0.0008
73923704|NCT00975481|147376547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.009|||<|0.0001|TWO_SIDED|95.0|13.7265|34.2916|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||34.2916|13.7265|<0.0001
73923705|NCT00975481|147376547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.4156|||<|0.0001|TWO_SIDED|95.0|19.116|39.7151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||39.7151|19.1160|<0.0001
73923706|NCT00975481|147376547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3979||||0.2239|TWO_SIDED|95.0|-16.7479|3.9521|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.9521|-16.7479|0.2239
73923707|NCT00975481|147376547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1396||||0.4326|TWO_SIDED|95.0|-14.5328|6.2526|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2526|-14.5328|0.4326
73967994|NCT03649659|147473933|SUPERIORITY||Odds Ratio (OR)|4.06|||<|0.0001|TWO_SIDED|99.9|2.54|6.48|||Regression, Logistic|Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.||||6.48|2.54|<0.0001
73967995|NCT03649659|147473934|SUPERIORITY||Odds Ratio (OR)|4.78|||<|0.0001|TWO_SIDED|99.9|2.84|8.05||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||8.05|2.84|<0.0001
73923708|NCT00975481|147376547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7283||||0.7447|TWO_SIDED|95.0|-12.195|8.7383|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.7383|-12.1950|0.7447
73967996|NCT03649659|147473935|SUPERIORITY||Odds Ratio (OR)|5.84|||<|0.0001|TWO_SIDED|99.9|3.59|9.51||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||9.51|3.59|<0.0001
73967997|NCT03649659|147473936|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8942|TWO_SIDED|99.9|0.25|3.54||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||3.54|0.25|0.8942
73967998|NCT05089734|147473950|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0534|TWO_SIDED|95.0|0.68|1.04||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||1.04|0.68|0.0534
73967999|NCT05089734|147473951|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1938|TWO_SIDED|95.0|0.77|1.11||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||1.11|0.77|0.1938
73968000|NCT05089734|147473952|SUPERIORITY||Difference in Proportions|-4.3||||0.9255|TWO_SIDED|95.0|-10.1|1.5||The 1-sided p-value is calculated using Cochran Mantel-Haenszel test adjusted for randomization stratification factors of histology, and best response to last prior immune therapy received.|Cochran-Mantel-Haenszel|||||1.5|-10.1|0.9255
73968001|NCT05089734|147473957|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.002|TWO_SIDED|95.0|0.61|0.91||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||0.91|0.61|0.0020
73968002|NCT05089734|147473958|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0125|TWO_SIDED|95.0|0.66|0.97||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||0.97|0.66|0.0125
73968003|NCT03779204|147473988|OTHER||Mean Difference (Final Values)|-2.0||||0.18|TWO_SIDED|95.0|-5.0|1.0|||ANCOVA|||||1.0|-5.0|0.18
74087015|NCT03407612|147728077|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.25|||||||t-test, 2 sided|||||||0.25
73923709|NCT00975481|147376547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.4069|||<|0.0001|TWO_SIDED|95.0|-40.6795|-20.1343|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1343|-40.6795|<0.0001
73923710|NCT00975481|147376547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.1487|||<|0.0001|TWO_SIDED|95.0|-38.4812|-17.8161|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.8161|-38.4812|<0.0001
73923711|NCT00975481|147376547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7374|||<|0.0001|TWO_SIDED|95.0|-36.1651|-15.3096|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.3096|-36.1651|<0.0001
73968004|NCT03779204|147473989|OTHER||Mean Difference (Final Values)|-1.4||||0.44|TWO_SIDED|95.0|-5.0|2.3|||ANCOVA|||||2.3|-5.0|0.44
73968005|NCT03779204|147473990|OTHER||Mean Difference (Final Values)|7.3||||0.38|TWO_SIDED|95.0|-9.7|24.4|||ANCOVA|||||24.4|-9.7|.38
73968006|NCT03779204|147473991|OTHER||Mean Difference (Final Values)|0.6||||0.76|TWO_SIDED|95.0|-3.3|4.4|||ANCOVA|||||4.4|-3.3|0.76
73968007|NCT03779204|147473992|OTHER|||||||0.68|||||||ANCOVA|||||||0.68
73968008|NCT03779204|147473993|OTHER||Mean Difference (Final Values)|-7.2||||0.12|TWO_SIDED|95.0|-16.4|2.0|||ANCOVA|||||2.0|-16.4|0.12
73968009|NCT03779204|147473994|OTHER||Mean Difference (Final Values)|-4.4||||0.34|TWO_SIDED|95.0|-13.7|5.0|||ANCOVA|||||5.0|-13.7|0.34
73968010|NCT03779204|147473996|OTHER||Mean Difference (Final Values)|-1.3||||0.62|TWO_SIDED|95.0|-6.6|4.0|||ANCOVA|||||4.0|-6.6|0.62
73968011|NCT04150718|147473999|OTHER||||||<|0.05||||||a priori threshold for statistical significance set at \<0.05|ANOVA|Repeated measures ANOVA, main effect of time, F(1,35) =4.73||||||<0.05
73968012|NCT04150718|147474000|OTHER||||||<|0.05||||||a priori threshold for statistical significance set at p\<0.05.|ANOVA|Repeated Measures ANOVA, main effect of time, F(1,39) = 4.20||||||<0.05
73968013|NCT04150718|147474001|OTHER||||||<|0.001||||||a priori threshold for statistical significance set at p \<0.05|ANOVA|Repeated measures ANOVA interaction, F(1,48) = 61.849||||||<0.001
73968014|NCT05493787|147474015|SUPERIORITY|||||||0.003||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Active Control message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending an Active Control message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.003
73968015|NCT05493787|147474015|SUPERIORITY||||||<|0.001||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Ease message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending an Ease message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||<.001
73968016|NCT05493787|147474015|SUPERIORITY||||||<|0.001||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Waiting for You message message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Waiting for You message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||<.001
73968017|NCT05493787|147474015|SUPERIORITY|||||||0.003||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent a Protect Yourself - Rare message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Protect Yourself - Rare Message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.003
73968018|NCT05493787|147474015|SUPERIORITY|||||||0.035||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent a Protect Yourself - Frequent message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Protect Yourself - Frequent message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.035
74087016|NCT03407612|147728078|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.04|||||||t-test, 2 sided|||||||0.04
74087017|NCT01316419|147728096|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Mean SBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||<0.0001
74087018|NCT01316419|147728099|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Mean DBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||<0.0001
74087019|NCT01316419|147728101|SUPERIORITY_OR_OTHER|||||||0.1099|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.1099
74087020|NCT01316419|147728102|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0197
74087021|NCT01316419|147728103|SUPERIORITY_OR_OTHER|||||||0.4543|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.4543
73923712|NCT00975481|147376547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.8134|||<|0.0001|TWO_SIDED|95.0|-45.9257|-25.7012|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-25.7012|-45.9257|<0.0001
73923713|NCT00975481|147376547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.5552|||<|0.0001|TWO_SIDED|95.0|-43.7675|-23.3429|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-23.3429|-43.7675|<0.0001
73923714|NCT00975481|147376547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1439|||<|0.0001|TWO_SIDED|95.0|-41.4754|-20.8124|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.8124|-41.4754|<0.0001
73923715|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.8779|||<|0.0001|TWO_SIDED|95.0|19.5658|30.1899|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.1899|19.5658|<0.0001
73923716|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.9857|||<|0.0001|TWO_SIDED|95.0|20.667|31.3043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||31.3043|20.6670|<0.0001
73923717|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0544||||0.4489|TWO_SIDED|95.0|-3.2911|7.3998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.3998|-3.2911|0.4489
73923718|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5743||||0.8329|TWO_SIDED|95.0|-4.7941|5.9427|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9427|-4.7941|0.8329
73923719|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6863||||0.5387|TWO_SIDED|95.0|-3.7203|7.0929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.0929|-3.7203|0.5387
73923720|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8235|||<|0.0001|TWO_SIDED|95.0|-28.1283|-17.5187|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.5187|-28.1283|<0.0001
74028492|NCT02940886|147610648|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.0162|TWO_SIDED|95.0|0.2|2.1|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.1|0.2|0.0162
74028493|NCT02940886|147610648|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.0569|TWO_SIDED|95.0|0.0|1.8|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.8|0.0|0.0569
74087022|NCT01316419|147728104|SUPERIORITY_OR_OTHER|||||||0.0152|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0152
74087023|NCT01316419|147728105|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0013
74087024|NCT01316419|147728106|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The change of QOL data collected using the EQ VAS is analyzed by paired t-test|Paired t test|||||||<0.0001
74087025|NCT01316419|147728108|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Mean LDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.0006
73923721|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.3036|||<|0.0001|TWO_SIDED|95.0|-29.64|-18.9672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.9672|-29.6400|<0.0001
73923722|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.1916|||<|0.0001|TWO_SIDED|95.0|-28.5768|-17.8064|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.8064|-28.5768|<0.0001
73923723|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9313|||<|0.0001|TWO_SIDED|95.0|-29.1559|-18.7066|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.7066|-29.1559|<0.0001
73923724|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4114|||<|0.0001|TWO_SIDED|95.0|-30.6869|-20.1358|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1358|-30.6869|<0.0001
73923725|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2994|||<|0.0001|TWO_SIDED|95.0|-29.6361|-18.9626|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.9626|-29.6361|<0.0001
73923726|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4301||||0.5349|TWO_SIDED|95.0|-5.9725|3.1123|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.1123|-5.9725|0.5349
73923727|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1367||||0.0001|TWO_SIDED|95.0|-13.6684|-4.605|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.6050|-13.6684|0.0001
73923728|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3357||||0.5637|TWO_SIDED|95.0|-3.2244|5.8958|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.8958|-3.2244|0.5637
73923729|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4065||||0.8612|TWO_SIDED|95.0|-4.1779|4.9909|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.9909|-4.1779|0.8612
73923730|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9175||||0.6954|TWO_SIDED|95.0|-3.7022|5.5373|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.5373|-3.7022|0.6954
73968019|NCT05493787|147474015|SUPERIORITY|||||||0.593||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Ease messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Ease messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.593
74087026|NCT01316419|147728109|SUPERIORITY_OR_OTHER|||||||0.4248|TWO_SIDED|||||Mean HDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.4248
74087027|NCT01316419|147728110|SUPERIORITY_OR_OTHER|||||||0.5579|TWO_SIDED|||||Mean Triglyceride change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.5579
74087028|NCT01316419|147728111|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Mean total cholesterol change from baseline at the last visit will be analyzed by paired t-test|Paired t-test|||||||0.0006
74087029|NCT00455962|147728116|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||Using previously collected data from a group of 18 predominantly Caucasian women undergoing a similar infusion we determined that 22 women would be necessary to identify a 30% difference in peak LH levels, the primary outcome measure, between AAW and CW with 80% power at a significance level of 0.05.||||0.69
73923731|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7658||||0.2287|TWO_SIDED|95.0|-1.7552|7.2868|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.2868|-1.7552|0.2287
73923732|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8366||||0.4267|TWO_SIDED|95.0|-2.7158|6.389|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.3890|-2.7158|0.4267
73923733|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3476||||0.314|TWO_SIDED|95.0|-2.2429|6.9381|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.9381|-2.2429|0.3140
73923734|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4724|||<|0.0001|TWO_SIDED|95.0|5.9992|14.9456|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.9456|5.9992|<0.0001
73923735|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.5432|||<|0.0001|TWO_SIDED|95.0|5.032|14.0544|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.0544|5.0320|<0.0001
73923736|NCT00975481|147376548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0542|||<|0.0001|TWO_SIDED|95.0|5.494|14.6144|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.6144|5.4940|<0.0001
73923737|NCT00975481|147376549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4728|||<|0.0001|TWO_SIDED|95.0|9.4718|19.4737|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||19.4737|9.4718|<0.0001
73923738|NCT00975481|147376549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7284|||<|0.0001|TWO_SIDED|95.0|14.7131|24.7437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||24.7437|14.7131|<0.0001
73923739|NCT00975481|147376549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2088||||0.9348|TWO_SIDED|95.0|-4.8289|5.2466|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.2466|-4.8289|0.9348
73923740|NCT00975481|147376549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7271||||0.5009|TWO_SIDED|95.0|-6.7841|3.3299|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.3299|-6.7841|0.5009
73923741|NCT00975481|147376549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3325||||0.8975|TWO_SIDED|95.0|-5.4245|4.7595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.7595|-5.4245|0.8975
74087030|NCT01197417|147728119|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment||Null hypothesis of equal distributions of primary length of stay between treatment arms within all randomization strata||||0.24
74087031|NCT01197417|147728120|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.12
74087032|NCT01197417|147728121|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.39
74087033|NCT01197417|147728122|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||<0.01
73923742|NCT00975481|147376549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.264|||<|0.0001|TWO_SIDED|95.0|-19.266|-9.2619|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.2619|-19.2660|<0.0001
73923743|NCT00975481|147376549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1999|||<|0.0001|TWO_SIDED|95.0|-21.2294|-11.1704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-11.1704|-21.2294|<0.0001
73923744|NCT00975481|147376549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.8053|||<|0.0001|TWO_SIDED|95.0|-19.8822|-9.7283|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.7283|-19.8822|<0.0001
73923745|NCT00975481|147376549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5195|||<|0.0001|TWO_SIDED|95.0|-24.4361|-14.603|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.6030|-24.4361|<0.0001
73923746|NCT00975481|147376549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4555|||<|0.0001|TWO_SIDED|95.0|-26.423|-16.488|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.4880|-26.4230|<0.0001
73923747|NCT00975481|147376549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0609|||<|0.0001|TWO_SIDED|95.0|-25.0872|-15.0345|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.0345|-25.0872|<0.0001
73923748|NCT00975481|147376550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1634|||<|0.0001|TWO_SIDED|95.0|1.9014|4.4254|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.4254|1.9014|<0.0001
73923749|NCT00975481|147376550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6706|||<|0.0001|TWO_SIDED|95.0|3.4066|5.9346|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9346|3.4066|<0.0001
73923750|NCT00975481|147376550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1478||||0.8184|TWO_SIDED|95.0|-1.1217|1.4173|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.4173|-1.1217|0.8184
73923751|NCT00975481|147376550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2211||||0.7324|TWO_SIDED|95.0|-1.054|1.4963|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.4963|-1.0540|0.7324
73923752|NCT00975481|147376550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0946||||0.8844|TWO_SIDED|95.0|-1.1898|1.3791|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.3791|-1.1898|0.8844
74087034|NCT01197417|147728123|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.11
74087035|NCT01197417|147728124|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.78
74087036|NCT01197417|147728125|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.46
73923753|NCT00975481|147376550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0156|||<|0.0001|TWO_SIDED|95.0|-4.2754|-1.7558|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.7558|-4.2754|<0.0001
73923754|NCT00975481|147376550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9423|||<|0.0001|TWO_SIDED|95.0|-4.2101|-1.6745|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.6745|-4.2101|<0.0001
73923755|NCT00975481|147376550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0688|||<|0.0001|TWO_SIDED|95.0|-4.3484|-1.7891|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.7891|-4.3484|<0.0001
73923756|NCT00975481|147376550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5228|||<|0.0001|TWO_SIDED|95.0|-5.7651|-3.2805|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.2805|-5.7651|<0.0001
73923757|NCT00975481|147376550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4495|||<|0.0001|TWO_SIDED|95.0|-5.7031|-3.1959|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.1959|-5.7031|<0.0001
73923758|NCT00975481|147376550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.576|||<|0.0001|TWO_SIDED|95.0|-5.8438|-3.3081|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.3081|-5.8438|<0.0001
73923759|NCT00975481|147376551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.0798|||<|0.0001|TWO_SIDED|95.0|34.0453|58.1142|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||58.1142|34.0453|<0.0001
73923760|NCT00975481|147376551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.8771|||<|0.0001|TWO_SIDED|95.0|37.8247|61.9295|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||61.9295|37.8247|<0.0001
73923761|NCT00975481|147376551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5797||||0.9248|TWO_SIDED|95.0|-12.6918|11.5325|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.5325|-12.6918|0.9248
73923762|NCT00975481|147376551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3632||||0.5857|TWO_SIDED|95.0|-15.5264|8.8|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.8000|-15.5264|0.5857
73923763|NCT00975481|147376551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4225||||0.4768|TWO_SIDED|95.0|-7.827|16.6719|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.6719|-7.8270|0.4768
74087037|NCT03919448|147728126|EQUIVALENCE|The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|101.55||||0.9766|TWO_SIDED|90.0|90.19|114.34||Power of ANOVA: 0,93|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||114.34|90.19|0.9766
73923764|NCT00975481|147376551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.6594|||<|0.0001|TWO_SIDED|95.0|-58.6804|-34.6385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-34.6385|-58.6804|<0.0001
73923765|NCT00975481|147376551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.443|||<|0.0001|TWO_SIDED|95.0|-61.5346|-37.3514|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-37.3514|-61.5346|<0.0001
73923766|NCT00975481|147376551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.6573|||<|0.0001|TWO_SIDED|95.0|-53.86|-29.4546|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-29.4546|-53.8600|<0.0001
73923767|NCT00975481|147376551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.4567|||<|0.0001|TWO_SIDED|95.0|-62.2925|-38.621|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-38.6210|-62.2925|<0.0001
73923768|NCT00975481|147376551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.2403|||<|0.0001|TWO_SIDED|95.0|-65.1923|-41.2882|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-41.2882|-65.1923|<0.0001
73923769|NCT00975481|147376551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.4546|||<|0.0001|TWO_SIDED|95.0|-57.5459|-33.3633|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-33.3633|-57.5459|<0.0001
73923770|NCT00975481|147376552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.845|||<|0.0001|TWO_SIDED|95.0|34.6464|59.0436|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||59.0436|34.6464|<0.0001
73923771|NCT00975481|147376552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|57.5013|||<|0.0001|TWO_SIDED|95.0|45.3036|69.6991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||69.6991|45.3036|<0.0001
73923772|NCT00975481|147376552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0913||||0.4129|TWO_SIDED|95.0|-17.3421|7.1595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.1595|-17.3421|0.4129
73923773|NCT00975481|147376552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1893||||0.8488|TWO_SIDED|95.0|-13.4954|11.1168|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.1168|-13.4954|0.8488
73923774|NCT00975481|147376552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1995||||0.4086|TWO_SIDED|95.0|-7.1963|17.5954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||17.5954|-7.1963|0.4086
73968020|NCT05493787|147474015|SUPERIORITY|||||||0.052||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Waiting for You messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.052
73923775|NCT00975481|147376552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.9363|||<|0.0001|TWO_SIDED|95.0|-64.1108|-39.7618|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-39.7618|-64.1108|<0.0001
73861806|NCT01344629|147269473|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|110.1||||||90.0|95.8|124.4||No statistical test|ANOVA|||||124.4|95.8|
73861807|NCT01344629|147269474|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|91.4||||||90.0|85.6|97.6||No statistical test|ANOVA|||||97.6|85.6|
73861808|NCT01344629|147269475|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.4||||||90.0|102.4|116.8||No statistical test|ANOVA|||||116.8|102.4|
73861809|NCT01344629|147269476|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.0||||||90.0|101.5|117.1||No statistical test|ANOVA|||||117.1|101.5|
73861810|NCT04063787|147269484|EQUIVALENCE|The null hypothesis is the difference is zero. Thus the equivalence margin equals zero.|Mean Difference (Final Values)|0.408|STANDARD_DEVIATION|1.05||0.012|TWO_SIDED||||||t-test, 2 sided|Paired t-test||Compare before and after use of Fist Assist||||0.012
73861811|NCT05545644|147269488|SUPERIORITY||Hedges g|0.48|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
73861812|NCT05545644|147269489|SUPERIORITY||Hedges g|0.37|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
73861813|NCT05545644|147269490|SUPERIORITY||Hedges g|0.04|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
73861814|NCT05545644|147269490|SUPERIORITY|Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).|Mean Difference (Final Values)|0.19|||||TWO_SIDED||||||||||Hedges g = .04; SE = .42|||
73861815|NCT05545644|147269491|SUPERIORITY||Hedges g|0.44|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
73861816|NCT00554099|147269493|SUPERIORITY_OR_OTHER||Mean Difference vs. Placebo|-3.0|STANDARD_ERROR_OF_MEAN|1.69||0.3781|ONE_SIDED|90.0||-0.809|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||-0.809||0.3781
73861817|NCT00554099|147269493|SUPERIORITY_OR_OTHER||Mean Difference vs. Placebo|-1.4|STANDARD_ERROR_OF_MEAN|1.74||0.6285|ONE_SIDED|90.0||0.815|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||0.815||0.6285
73861818|NCT00554099|147269493|SUPERIORITY_OR_OTHER||Mean Difference vs. Asacol|1.6|STANDARD_ERROR_OF_MEAN|1.58||0.4365|ONE_SIDED|90.0||3.573|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||3.573||0.4365
73861819|NCT00554099|147269494|SUPERIORITY_OR_OTHER||Difference vs. Placebo|21.1|STANDARD_ERROR_OF_MEAN|12.53||0.0576|ONE_SIDED|90.0|5.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||5.1|0.0576
73923776|NCT00975481|147376552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.0343|||<|0.0001|TWO_SIDED|95.0|-60.2801|-35.7885|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.7885|-60.2801|<0.0001
73968021|NCT05493787|147474015|SUPERIORITY|||||||0.952||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Protect Yourself - Rare messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Protect Yourself - Rare messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.952
73861820|NCT00554099|147269494|SUPERIORITY_OR_OTHER||Difference vs. Placebo|6.8|STANDARD_ERROR_OF_MEAN|13.27||0.3248|ONE_SIDED|90.0|-10.2||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-10.2|0.3248
73861821|NCT00554099|147269494|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-14.4|STANDARD_ERROR_OF_MEAN|12.87||0.8596|ONE_SIDED|90.0|-30.8||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-30.8|0.8596
73861822|NCT00554099|147269495|SUPERIORITY_OR_OTHER||Difference vs. Placebo|16.7|STANDARD_ERROR_OF_MEAN|14.0||0.1266|ONE_SIDED|90.0|-1.3||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-1.3|0.1266
73861823|NCT00554099|147269495|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-20.8|STANDARD_ERROR_OF_MEAN|14.13||0.9288|ONE_SIDED|90.0|-38.9||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-38.9|0.9288
73861824|NCT00554099|147269495|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-37.5|STANDARD_ERROR_OF_MEAN|12.98||0.9962|ONE_SIDED|90.0|-54.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-54.1|0.9962
73861825|NCT00554099|147269496|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|-1.4|STANDARD_ERROR_OF_MEAN|2.784||0.3082|ONE_SIDED|90.0||2.196|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||2.196||0.3082
73861826|NCT00554099|147269496|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|0.083|STANDARD_ERROR_OF_MEAN|2.903||0.5113|ONE_SIDED|90.0||3.832|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||3.832||0.5113
73968022|NCT05493787|147474015|SUPERIORITY|||||||0.386||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Protect Yourself - Frequent messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.386
73968023|NCT05493787|147474015|SUPERIORITY|||||||0.498||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Waiting for You messages. Analysis combines across November and December send dates.||||.498
73968024|NCT05493787|147474015|SUPERIORITY|||||||0.935||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Protect Yourself - Rare messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Protect Yourself - Rare messages. Analysis combines across November and December send dates.||||.935
73968025|NCT05493787|147474015|SUPERIORITY|||||||0.504||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Protect Yourself - Frequent message messages. Analysis combines across November and December send dates.||||.504
73861827|NCT00554099|147269496|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Mesalamine|1.483|STANDARD_ERROR_OF_MEAN|2.836||0.6988|ONE_SIDED|90.0||5.145|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||5.145||0.6988
73968026|NCT05493787|147474015|SUPERIORITY|||||||0.19||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Rare and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Rare and Waiting for You messages. Analysis combines across November and December send dates.||||.190
73968027|NCT05493787|147474015|SUPERIORITY|||||||0.027||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Frequent messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Frequent and Waiting for You messages. Analysis combines across November and December send dates.||||.027
73968028|NCT05493787|147474015|SUPERIORITY|||||||0.854||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Rare and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Rare and Protect Yourself - Frequent messages. Analysis combines across November and December send dates.||||.854
73968029|NCT05493787|147474015|SUPERIORITY|||||||0.637||||||The reported p-value (2-tailed) is for the interaction term between message send date (November, December) and message (any message arm no message)|Regression, Linear|||"Null Hypothesis: Messages sent in November and December are equally effective at promoting flu-shot self-scheduling. Alternative hypothesis: Messages sent in November and December are differentially effective.~To test the alternative hypothesis, all message arms (Active control, Ease, Waiting for you, Protect yourself - rare, Protect yourself - frequent) were combined and compared with Passive control."||||.637
74087038|NCT03919448|147728126|EQUIVALENCE|The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|100.95||||0.9766|TWO_SIDED|90.0|89.75|113.55||Power of ANOVA: 0,93|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||113.55|89.75|0.9766
73968030|NCT06074523|147474072|EQUIVALENCE|Comparing three conditions in a basic science experiment in healthy adults.|partial eta squared|0.81|||<|0.001|TWO_SIDED||||||ANOVA|||Comparing Cued Suppression Task; Positive, Negative, and Neutral Cue condtions||||<.001
73968031|NCT06074523|147474073|EQUIVALENCE|P\<.05 criterion|cohen's d|0.24||||0.08|TWO_SIDED||||||t-test, 2 sided|||Comparing performance on target absent and target present trials||||.08
73968032|NCT06074523|147474074|OTHER||Slope|-0.37||||0.007|TWO_SIDED|95.0|-0.5803|-0.1135|||correlation|||Relationship between Cued Attention Negative Cue Benefit (Neutral Cue RT- Negative Cue RT) and working memory capacity.||-0.1135|-0.5803|.007
74087039|NCT03919448|147728126|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|100.59||||0.9766|TWO_SIDED|90.0|88.16|114.77|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||114.77|88.16|0.9766
73861828|NCT00554099|147269497|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|-0.428|STANDARD_ERROR_OF_MEAN|3.067||0.4448|ONE_SIDED|90.0||3.541|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||3.541||0.4448
73861829|NCT00554099|147269497|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|0.825|STANDARD_ERROR_OF_MEAN|3.151||0.6029|ONE_SIDED|90.0||4.903|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||4.903||0.6029
73923777|NCT00975481|147376552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.6455|||<|0.0001|TWO_SIDED|95.0|-53.9964|-29.2946|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-29.2946|-53.9964|<0.0001
73923778|NCT00975481|147376552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.5926|||<|0.0001|TWO_SIDED|95.0|-74.5881|-50.5971|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-50.5971|-74.5881|<0.0001
73923779|NCT00975481|147376552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.6906|||<|0.0001|TWO_SIDED|95.0|-70.7965|-46.5847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-46.5847|-70.7965|<0.0001
73923780|NCT00975481|147376552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-52.3018|||<|0.0001|TWO_SIDED|95.0|-64.5427|-40.0609|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-40.0609|-64.5427|<0.0001
73923781|NCT00975481|147376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4604||||0.0016|TWO_SIDED|95.0|6.321|26.5998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||26.5998|6.3210|0.0016
73923782|NCT00975481|147376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.9971|||<|0.0001|TWO_SIDED|95.0|17.8247|38.1696|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||38.1696|17.8247|<0.0001
73923783|NCT00975481|147376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1425||||0.8254|TWO_SIDED|95.0|-11.3591|9.0742|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||9.0742|-11.3591|0.8254
73923784|NCT00975481|147376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.747||||0.8858|TWO_SIDED|95.0|-9.5075|11.0015|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.0015|-9.5075|0.8858
73923785|NCT00975481|147376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4279||||0.5128|TWO_SIDED|95.0|-6.8972|13.7529|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||13.7529|-6.8972|0.5128
73923786|NCT00975481|147376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6028||||0.0008|TWO_SIDED|95.0|-27.7485|-7.4572|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-7.4572|-27.7485|0.0008
73923787|NCT00975481|147376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7134||||0.0028|TWO_SIDED|95.0|-25.9136|-5.5132|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-5.5132|-25.9136|0.0028
73923788|NCT00975481|147376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0325||||0.0135|TWO_SIDED|95.0|-23.3295|-2.7355|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.7355|-23.3295|0.0135
73968033|NCT06074523|147474075|OTHER||Slope|-0.27||||0.046|TWO_SIDED|95.0|-0.5015|-0.002414|||correlation|||Correlation of Inattentive Traits subscale and learned suppression (difference in RT between target absent and target present trials)||-0.002414|-0.5015|.046
73968034|NCT04318548|147474166|NON_INFERIORITY|NI was to be demonstrated if the lower limit (LL) of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against M14459 (fHbp) strain was above (\>) 0.5|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.06|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority (NI) of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.06|0.77|
73968035|NCT04318548|147474166|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against 96217 (NadA) strain was \>0.5|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.04|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.04|0.75|
73968036|NCT04318548|147474166|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against NZ98/254 (PorA) strain was \>0.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.12|0.76|
74028494|NCT02940886|147610649|SUPERIORITY||Mean Difference (Final Values)|43.7|||<|0.0001|TWO_SIDED|95.0|38.1|49.3|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||49.3|38.1|<0.0001
74028495|NCT02940886|147610649|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.0375|TWO_SIDED|95.0|0.3|9.8|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||9.8|0.3|0.0375
74028496|NCT02940886|147610649|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.6027|TWO_SIDED|95.0|-4.0|2.3|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||2.3|-4.0|0.6027
74028497|NCT02940886|147610649|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8207|TWO_SIDED|95.0|-2.7|3.4|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||3.4|-2.7|0.8207
74028498|NCT02940886|147610650|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.0422|TWO_SIDED|95.0|0.04|2.01|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||2.01|0.04|0.0422
73923789|NCT00975481|147376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.1396|||<|0.0001|TWO_SIDED|95.0|-39.1071|-19.1721|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.1721|-39.1071|<0.0001
74028499|NCT02940886|147610650|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.4646|TWO_SIDED|95.0|-1.44|0.66|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.66|-1.44|0.4646
73923790|NCT00975481|147376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.2502|||<|0.0001|TWO_SIDED|95.0|-37.3224|-17.178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.1780|-37.3224|<0.0001
73923791|NCT00975481|147376553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.5693|||<|0.0001|TWO_SIDED|95.0|-34.7614|-14.3772|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.3772|-34.7614|<0.0001
73923792|NCT00975481|147376554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2535||||0.0005|TWO_SIDED|95.0|0.5623|1.9446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.9446|0.5623|0.0005
73923793|NCT00975481|147376554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.501|||<|0.0001|TWO_SIDED|95.0|2.8073|4.1948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.1948|2.8073|<0.0001
73923794|NCT00975481|147376554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3418||||0.3347|TWO_SIDED|95.0|-0.3559|1.0396|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.0396|-0.3559|0.3347
73923795|NCT00975481|147376554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3208||||0.3678|TWO_SIDED|95.0|-0.3808|1.0225|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.0225|-0.3808|0.3678
73923796|NCT00975481|147376554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.9197|TWO_SIDED|95.0|-0.6686|0.7406|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.7406|-0.6686|0.9197
73923797|NCT00975481|147376554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9117||||0.0099|TWO_SIDED|95.0|-1.6013|-0.222|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2220|-1.6013|0.0099
73923798|NCT00975481|147376554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9326||||0.0088|TWO_SIDED|95.0|-1.6269|-0.2384|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2384|-1.6269|0.0088
73923799|NCT00975481|147376554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2175||||0.0008|TWO_SIDED|95.0|-1.9171|-0.5178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.5178|-1.9171|0.0008
73923800|NCT00975481|147376554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1592|||<|0.0001|TWO_SIDED|95.0|-3.838|-2.4804|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.4804|-3.8380|<0.0001
73923801|NCT00975481|147376554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1802|||<|0.0001|TWO_SIDED|95.0|-3.8656|-2.4947|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.4947|-3.8656|<0.0001
73923802|NCT00975481|147376554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.465|||<|0.0001|TWO_SIDED|95.0|-4.1583|-2.7717|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.7717|-4.1583|<0.0001
73861830|NCT00554099|147269497|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Mesalamine|1.253|STANDARD_ERROR_OF_MEAN|2.996||0.6615|ONE_SIDED|90.0||5.129|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||5.129||0.6615
73861831|NCT00554099|147269498|SUPERIORITY_OR_OTHER||Difference vs. Placebo|2.6|STANDARD_ERROR_OF_MEAN|4.2||0.7165|ONE_SIDED|90.0||7.9|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||7.9||0.7165
73861832|NCT00554099|147269498|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-2.4|STANDARD_ERROR_OF_MEAN|2.41||0.1708|ONE_SIDED|90.0||0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||0.6||0.1708
73861833|NCT00554099|147269498|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-5.0|STANDARD_ERROR_OF_MEAN|3.45||0.1039|ONE_SIDED|90.0||-0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||-0.6||0.1039
73923803|NCT00975481|147376555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2943|||<|0.0001|TWO_SIDED|95.0|4.0783|6.5102|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.5102|4.0783|<0.0001
73968037|NCT04318548|147474166|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against M13520 (NHBA) strain was \>0.5|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.06|0.73|
73968038|NCT04318548|147474167|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men A serogroup was \>0.5.|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.78|1.14|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men A, at one month after the vaccination with MenACWY (at Day 31).||1.14|0.78|
73968039|NCT04318548|147474167|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men C serogroup was \>0.5.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.86|1.44|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men C, at one month after the vaccination with MenACWY (at Day 31).||1.44|0.86|
73968040|NCT04318548|147474167|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men W serogroup was \>0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.21|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men W, at one month after the vaccination with MenACWY (at Day 31).||1.21|0.82|
73968041|NCT04318548|147474167|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men Y serogroup was \>0.5.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.84|1.27|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men Y, at one month after the vaccination with MenACWY (at Day 31).||1.27|0.84|
73968042|NCT04318548|147474169|OTHER||GMT Ratio|0.76|||||TWO_SIDED|95.0|0.64|0.91|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis M14459 (fHbp) strain at one month after the fisrt vaccination with rMenB+OMV NZ (at Day 31).||0.91|0.64|
73968043|NCT04318548|147474169|OTHER||GMT Ratio|0.62|||||TWO_SIDED|95.0|0.49|0.77|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis 96217 (NadA) strain at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.77|0.49|
73861834|NCT00554099|147269499|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-7.5|STANDARD_ERROR_OF_MEAN|8.21||0.1907|ONE_SIDED|90.0||3.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||3.0||0.1907
73861835|NCT00554099|147269499|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-8.2|STANDARD_ERROR_OF_MEAN|8.4||0.173|ONE_SIDED|90.0||2.5|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||2.5||0.1730
73861836|NCT00554099|147269499|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-0.7|STANDARD_ERROR_OF_MEAN|7.61||0.4613|ONE_SIDED|90.0||9.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||9.0||0.4613
73861837|NCT00554099|147269500|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-2.9|STANDARD_ERROR_OF_MEAN|11.7||0.3983|ONE_SIDED|90.0||12.1|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||12.1||0.3983
74028500|NCT02940886|147610650|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.5703|TWO_SIDED|95.0|-1.39|0.76|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.76|-1.39|0.5703
73861838|NCT00554099|147269500|SUPERIORITY_OR_OTHER||Difference vs. Placebo|6.0|STANDARD_ERROR_OF_MEAN|12.66||0.6721|ONE_SIDED|90.0||22.2|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||22.2||0.6721
73923804|NCT00975481|147376555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8983|||<|0.0001|TWO_SIDED|95.0|5.6799|8.1167|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.1167|5.6799|<0.0001
73923805|NCT00975481|147376555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6545||||0.2917|TWO_SIDED|95.0|-0.5676|1.8767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.8767|-0.5676|0.2917
73923806|NCT00975481|147376555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8489||||0.1738|TWO_SIDED|95.0|-0.3784|2.0763|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.0763|-0.3784|0.1738
73923807|NCT00975481|147376555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9372||||0.1373|TWO_SIDED|95.0|-0.3024|2.1767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.1767|-0.3024|0.1373
73923808|NCT00975481|147376555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6397|||<|0.0001|TWO_SIDED|95.0|-5.8537|-3.4257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.4257|-5.8537|<0.0001
73923809|NCT00975481|147376555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4453|||<|0.0001|TWO_SIDED|95.0|-5.6662|-3.2244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.2244|-5.6662|<0.0001
73923810|NCT00975481|147376555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3571|||<|0.0001|TWO_SIDED|95.0|-5.5887|-3.1255|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.1255|-5.5887|<0.0001
73923811|NCT00975481|147376555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2437|||<|0.0001|TWO_SIDED|95.0|-7.4397|-5.0477|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-5.0477|-7.4397|<0.0001
73923812|NCT00975481|147376555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0493|||<|0.0001|TWO_SIDED|95.0|-7.2568|-4.8419|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.8419|-7.2568|<0.0001
74028501|NCT01306058|147610695|NON_INFERIORITY|Paired T-test. Two tailed.|||||<|0.05|||||||Wilcoxon signed rank test|||||||<0.05
74028502|NCT01306058|147610696|NON_INFERIORITY|Paired T-test. Two tailed.|||||<|0.0001||||||Cycle 1 day 15 vs. cycle 1 day 1|Wilcoxon signed rank test|||||||<0.0001
74028503|NCT01306058|147610696|NON_INFERIORITY|Cycle 2 day 1 vs. cycle 1 day 1. Paired T-test. Two tailed.|||||<|0.0001|||||||Wilcoxon signed rank test|||||||<0.0001
74028504|NCT01306058|147610696|NON_INFERIORITY|eos (end of study) vs. cycle 1 day 1. Paired T-test. Two tailed.||||||0.0009|||||||Wilcoxon signed rank test|||||||0.0009
73861839|NCT00554099|147269500|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|8.9|STANDARD_ERROR_OF_MEAN|12.23||0.7703|ONE_SIDED|90.0||24.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||24.6||0.7703
73861840|NCT02008357|147269529|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.26|TWO_SIDED|95.0|-0.816|0.22|||Natural Cubic Spline (NCS) method|||||0.220|-0.816|0.260
73923813|NCT00975481|147376555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9611|||<|0.0001|TWO_SIDED|95.0|-7.1812|-4.741|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.7410|-7.1812|<0.0001
73968044|NCT04318548|147474169|OTHER||GMT Ratio|0.73|||||TWO_SIDED|95.0|0.58|0.91|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis NZ98/254 (PorA) strain at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.91|0.58|
73923814|NCT00975481|147376556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.6205|||<|0.0001|TWO_SIDED|95.0|-33.1192|-20.1219|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1219|-33.1192|<0.0001
73923815|NCT00975481|147376556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.5724|||<|0.0001|TWO_SIDED|95.0|-39.1073|-26.0375|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.0375|-39.1073|<0.0001
73923816|NCT00975481|147376556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8966||||0.5685|TWO_SIDED|95.0|-4.6607|8.454|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.4540|-4.6607|0.5685
73923817|NCT00975481|147376556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5761||||0.2848|TWO_SIDED|95.0|-10.159|3.0068|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.0068|-10.1590|0.2848
73923818|NCT00975481|147376556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1754||||0.344|TWO_SIDED|95.0|-9.7855|3.4347|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.4347|-9.7855|0.3440
73923819|NCT00975481|147376556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5172|||<|0.0001|TWO_SIDED|95.0|22.0454|34.989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||34.9890|22.0454|<0.0001
73968045|NCT04318548|147474169|OTHER||GMT Ratio|0.76|||||TWO_SIDED|95.0|0.64|0.9|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis M13520 (NHBA) at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.90|0.64|
73861841|NCT02008357|147269531|SUPERIORITY||LS Mean difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.28||0.1|TWO_SIDED|95.0|-0.089|1.02|||Natural Cubic Spline (NCS) method|||||1.020|-0.089|0.100
73923820|NCT00975481|147376556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0445|||<|0.0001|TWO_SIDED|95.0|16.5383|29.5506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||29.5506|16.5383|<0.0001
73923821|NCT00975481|147376556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4452|||<|0.0001|TWO_SIDED|95.0|16.8772|30.0131|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.0131|16.8772|<0.0001
73923822|NCT00975481|147376556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.469|||<|0.0001|TWO_SIDED|95.0|28.1136|40.8244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||40.8244|28.1136|<0.0001
73923823|NCT00975481|147376556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.9963|||<|0.0001|TWO_SIDED|95.0|22.5734|35.4192|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||35.4192|22.5734|<0.0001
73923824|NCT00975481|147376556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.397|||<|0.0001|TWO_SIDED|95.0|22.8946|35.8994|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||35.8994|22.8946|<0.0001
73923825|NCT00975481|147376557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.6044|||<|0.0001|TWO_SIDED|95.0|33.4091|59.7996|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||59.7996|33.4091|<0.0001
73968046|NCT03771898|147474196|SUPERIORITY|Survival probability free of loss of locomotion estimated up to Week 106 (or two years).|Difference in survival probability (%)|-2.2|||=|0.585|TWO_SIDED|95.0|-22.2|17.7||One-sided, over time intervals during entire follow-up. Stratified generalized log-rank test was used, where matching identification created from matching process in SAS PSMATCH Procedure used as strata.|Log Rank||For the shared time interval up to Week 106 (or two years).|Interval censoring survival analysis.||17.7|-22.2|=0.585
73968047|NCT05563246|147474223|SUPERIORITY||LS Mean Difference (Final Values)|-47.61|||<|0.001|TWO_SIDED|95.0|-57.68|-35.14|||Mixed Models Analysis|||||-35.14|-57.68|<.001
73968048|NCT05563246|147474223|SUPERIORITY||LS Mean Difference (Final Values)|-81.66|||<|0.001|TWO_SIDED|95.0|-84.62|-78.13|||Mixed Models Analysis|||||-78.13|-84.62|<.001
73968049|NCT05563246|147474223|SUPERIORITY||LS Mean Difference (Final Values)|-85.77|||<|0.001|TWO_SIDED|95.0|-88.03|-83.09|||Mixed Models Analysis|||||-83.09|-88.03|<.001
73968050|NCT05563246|147474224|SUPERIORITY||LS Mean Difference (Final Values)|-40.38|||<|0.001|TWO_SIDED|95.0|-50.45|-28.27|||Mixed Models Analysis|||||-28.27|-50.45|<.001
73968051|NCT05563246|147474224|SUPERIORITY||LS Mean Difference (Final Values)|-69.95|||<|0.001|TWO_SIDED|95.0|-74.23|-64.96|||Mixed Models Analysis|||||-64.96|-74.23|<.001
73968052|NCT05563246|147474224|SUPERIORITY||LS Mean Difference (Final Values)|-68.9|||<|0.001|TWO_SIDED|95.0|-73.27|-63.81|||Mixed Models Analysis|||||-63.81|-73.27|<.001
73968053|NCT05563246|147474225|SUPERIORITY||Risk Difference (RD)|58.15|||<|0.001|TWO_SIDED|95.0|40.3|75.99|||Regression, Logistic|||||75.99|40.30|<.001
73968054|NCT05563246|147474225|SUPERIORITY||Risk Difference (RD)|89.87|||<|0.001|TWO_SIDED|95.0|81.54|98.2|||Regression, Logistic|||||98.20|81.54|<.001
73968055|NCT05563246|147474225|SUPERIORITY||Risk Difference (RD)|90.71|||<|0.001|TWO_SIDED|95.0|82.8|98.62|||Regression, Logistic|||||98.62|82.80|<.001
73968056|NCT05563246|147474226|SUPERIORITY||Risk Difference (RD)|35.18|||<|0.001|TWO_SIDED|95.0|18.9|51.46|||Regression, Logistic|||||51.46|18.90|<.001
73968057|NCT05563246|147474226|SUPERIORITY||Risk Difference (RD)|78.18|||<|0.001|TWO_SIDED|95.0|67.7|88.65|||Regression, Logistic|||||88.65|67.70|<.001
73968058|NCT05563246|147474226|SUPERIORITY||Risk Difference (RD)|73.62|||<|0.001|TWO_SIDED|95.0|63.65|83.58|||Regression, Logistic|||||83.58|63.65|<.001
73968059|NCT05563246|147474227|SUPERIORITY||LS Mean Difference (Final Values)|-8.94||||0.11|TWO_SIDED|95.0|-18.84|2.17|||Mixed Models Analysis|||||2.17|-18.84|0.110
73968060|NCT05563246|147474227|SUPERIORITY||LS Mean Difference (Final Values)|-13.05||||0.004|TWO_SIDED|95.0|-20.92|-4.4|||Mixed Models Analysis|||||-4.40|-20.92|0.004
73968061|NCT05563246|147474227|SUPERIORITY||LS Mean Difference (Final Values)|-16.13|||<|0.001|TWO_SIDED|95.0|-23.69|-7.84|||Mixed Models Analysis|||||-7.84|-23.69|<.001
73923826|NCT00975481|147376557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.7222|||<|0.0001|TWO_SIDED|95.0|37.5038|63.9407|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||63.9407|37.5038|<0.0001
73968062|NCT05563246|147474228|SUPERIORITY||LS Mean Difference (Final Values)|35.27||||0.131|TWO_SIDED|95.0|-8.63|100.27|||Mixed Models Analysis|||||100.27|-8.63|0.131
73968063|NCT05563246|147474228|SUPERIORITY||LS Mean Difference (Final Values)|8.32||||0.627|TWO_SIDED|95.0|-21.62|49.7|||Mixed Models Analysis|||||49.70|-21.62|0.627
73968064|NCT05563246|147474228|SUPERIORITY||LS Mean Difference (Final Values)|-6.08||||0.701|TWO_SIDED|95.0|-31.89|29.51|||Mixed Models Analysis|||||29.51|-31.89|0.701
73968065|NCT02167867|147474232|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||t=+7.76||||<0.0001
73968066|NCT04784559|147474246|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8751|TWO_SIDED|95.0|0.727|1.53||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors,|Plitidepsin 2.5 mg arm versus Control arm||1.53|0.727|0.8751
73968067|NCT04784559|147474246|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.0625|TWO_SIDED|95.0|0.96|1.96||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||1.96|0.960|0.0625
73968068|NCT04784559|147474247|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.5945|TWO_SIDED|95.0|0.655|1.37||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 2.5 mg arm versus Control arm||1.37|0.655|0.5945
73968069|NCT04784559|147474247|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3358|TWO_SIDED|95.0|0.827|1.7||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||1.70|0.827|0.3358
74028505|NCT01666444|147610698|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.22||||0.923|ONE_SIDED|92.0||1.48||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (\<= 6 months vs \> 6 months), and performance status (0 vs 1).|Treatment Hazard ratio for overall survival (PLD+VTX relative to PLD+placebo). Survival is measured from date of enrollment and randomization on the study until death from any cause, or date of last contact.|The null hypothesis is that the hazards of death are equal for both treatment groups. The primary assessment of this hypothesis was done with a stratified logrank test and the study was to be considered sufficiently mature to assess this hypothesis when at least 211 deaths had occurred among all individuals enrolled. Type I error was to be set to 0.08 for a one-sided test and the power for detecting a 30% reduction in the hazard (hazard ratio=0.70) due to VTX-2337 was 88.2%.||1.48||0.923
74028506|NCT01666444|147610699|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.21||||0.943|ONE_SIDED|98.0||1.56||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (\<= 6 months vs \> 6 months), and performance status (0 vs 1).||The null hypothesis is that the hazards of first progression or death are equal for both treatment groups. The primary assessment was to use a stratified logrank test and the study was to be considered sufficiently mature when survival is mature for analysis. Type I error was to be set to 0.02 for a one-sided test and the power for detecting a 31% reduction in the hazard (hazard ratio=0.69) due to VTX-2337 was expected to be approximately 83%.||1.56||0.943
74028507|NCT04011436|147610721|SUPERIORITY|In the bivariate analysis, a comparison was initially made of each of the domains of the Kujala test, for the assessment of pain at baseline, assessing the differences between the intervention groups using the chi-square or Fisher's exact tests. The Spearman correlation coefficient was used to evaluate the relationship between two continuous variables, such as Q angle and anterior knee pain, assessing the correlation marginally and conditionally on each of the treatment groups.|difference in frequency distribution|0.05|||<|0.05|TWO_SIDED|95.0|0.025|0.05|||Fisher Exact|we also used Chi-squared for the domains of pain and limp.||||0.05|0.025|<0.05
74028508|NCT04011436|147610722|SUPERIORITY|For the analysis of the differences in medians between the groups, taking into account that the outcomes did not present a normal distribution, and assuming the assumption of independence of the variables, the non-parametric Mann-Whitney U test was used.|Median Difference (Final Values)|0.058|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated Value was done for the assessment of change in pain with Visual Analogue Scale.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
74028509|NCT04011436|147610723|SUPERIORITY||Median Difference (Final Values)|0.75|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated value was calculated for Change in Patellofemoral Misalignment With Q Angle´s Exam.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
74028510|NCT04011436|147610724|SUPERIORITY||Median Difference (Final Values)|0.001|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated Value was calculated for the change in core strength with McGill´s Exam.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
74087040|NCT03919448|147728127|EQUIVALENCE|The comparable bioavailability was achieved if 90% confidence intervals (CIs) for the test to reference ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|90.82||||0.3617|TWO_SIDED|90.0|81.21|101.57||Power of ANOVA: 0,95|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||101.57|81.21|0.3617
74087041|NCT03919448|147728127|EQUIVALENCE|The comparable bioavailability was achieved if 90% confidence intervals (CIs) for the test to reference ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|94.87||||0.3617|TWO_SIDED|90.0|84.91|105.99||Power of ANOVA: 0.95|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||105.99|84.91|0.3617
74028511|NCT04011436|147610725|SUPERIORITY||Median Difference (Final Values)|0.67|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated value was calculated for the change in Quadriceps and Gluteus Strength With Squat´s Test.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
74028512|NCT04011436|147610726|SUPERIORITY||Median Difference (Final Values)|0.55|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||"Estimated value was calculated for the change in Static Balance with Single Leg Stance.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||<0.05
74028513|NCT04011436|147610727|SUPERIORITY||Median Difference (Final Values)|0.492|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||"Estimated value was calculated for the change in the total amount of Physical Activity reported in minutes.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||<0.05
74028514|NCT01371838|147610763|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated in CE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in CE Population. If non-inferioirity was achieved then a test of superioirty was conducted whereby if lower limit of 95% CI for the difference was \>0% superioirty was concluded.|Risk Difference (RD)|9.9|||||TWO_SIDED|95.0|2.8|17.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE in adult subjects with CABP.||17.1|2.8|
73923827|NCT00975481|147376557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6987||||0.9174|TWO_SIDED|95.0|-13.9815|12.584|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||12.5840|-13.9815|0.9174
74028515|NCT01371838|147610764|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.7|||||TWO_SIDED|95.0|4.9|16.4||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||16.4|4.9|
74028516|NCT01371838|147610765|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.5|||||TWO_SIDED|95.0|1.8|15.4||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||15.4|1.8|
74028517|NCT01371838|147610766|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.0|||||TWO_SIDED|95.0|6.8|19.2||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments. If lower limit of 95% CI for the risk difference was \>0% superioirty was concluded in this population.|||19.2|6.8|
74028518|NCT01371838|147610767|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|2.7|27.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||27.1|2.7|
74028519|NCT01371838|147610768|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.2|25.8||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||25.8|-2.2|
74028520|NCT01371838|147610771|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|2.7|27.1||||RD is (Ceftaroline-Ceftriaxone) microbiologically favourable outcome rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||27.1|2.7|
73923828|NCT00975481|147376557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5629||||0.5002|TWO_SIDED|95.0|-17.9006|8.7749|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.7749|-17.9006|0.5002
74028521|NCT01371838|147610772|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.2|25.8||||RD is (Ceftaroline-Ceftriaxone) microbiologically favourable outcome rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||25.8|-2.2|
74028522|NCT01371838|147610773|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.0|||||TWO_SIDED|95.0|6.8|19.2||||RD is Ceftaroline minus Ceftriaxone overall success rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||19.2|6.8|
74028523|NCT01371838|147610774|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.9|||||TWO_SIDED|95.0|2.8|17.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||17.1|2.8|
74028524|NCT01371838|147610775|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-2.5|3.0||||RD is Ceftaroline minus Ceftriaxone No-relapse rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||3.0|-2.5|
74028525|NCT01371838|147610776|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-2.4|4.5||||RD is Ceftaroline minus Ceftriaxone No-relapse rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||4.5|-2.4|
74028526|NCT00641043|147610785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.71|-0.3|||ANCOVA|||Linagliptin vs. Placebo||-0.30|-0.71|<0.0001
74028527|NCT00641043|147610786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.52|-0.24|||ANCOVA|||Linagliptin vs. Placebo||-0.24|-0.52|<0.0001
74028528|NCT00641043|147610787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.67|-0.32|||ANCOVA|||Linagliptin vs. Placebo||-0.32|-0.67|<0.0001
74028529|NCT00641043|147610788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.32|||ANCOVA|||Linagliptin vs. Placebo||-0.32|-0.70|<0.0001
73861842|NCT02008357|147269533|SUPERIORITY||LS Mean difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.34||0.082|TWO_SIDED|95.0|-1.265|0.076|||Natural Cubic Spline (NCS) method|||||0.076|-1.265|0.082
73968070|NCT04784559|147474248|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7252|TWO_SIDED|95.0|0.604|2.06||2-sided|p-value based on proportional odds model|Proportional odds model with fixed effects of treatment group and randomisation stratification factors|Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors|Plitidepsin 2.5 mg arm versus Control arm||2.06|0.604|0.7252
73968071|NCT04784559|147474248|SUPERIORITY||Odds Ratio (OR)|1.69||||0.091|TWO_SIDED|95.0|0.92|3.11||2-sided|p-value based on proportional odds model|Proportional odds model with fixed effects of treatment group and randomisation stratification factors|Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||3.11|0.920|0.0910
73968072|NCT03420833|147474253|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
73968073|NCT03420833|147474253|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||0.009
74028530|NCT00641043|147610789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001||95.0|-21.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-21.1|<0.0001
74028531|NCT00641043|147610790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001||95.0|-22.3|-10.5|||ANCOVA|||Linagliptin vs. Placebo||-10.5|-22.3|<0.0001
74028532|NCT00641043|147610791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|STANDARD_ERROR_OF_MEAN|3.2|<|0.0001||95.0|-19.5|-7.0|||ANCOVA|||Linagliptin vs. Placebo||-7.0|-19.5|<0.0001
74028533|NCT00641043|147610792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-20.5|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-20.5|<0.0001
73861843|NCT02008357|147269535|SUPERIORITY||LS Mean difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.0073|<|0.001|TWO_SIDED|95.0|-0.057|-0.028|||ANCOVA|||||-0.028|-0.057|<0.001
73861844|NCT02008357|147269536|SUPERIORITY||LS Mean difference (Final Values)|3.239|STANDARD_ERROR_OF_MEAN|32.8719||0.922|TWO_SIDED|95.0|-62.02|68.498|||ANCOVA|||Cerebrospinal fluid Tau Protein Immunoassay||68.498|-62.020|0.922
73861845|NCT02008357|147269536|SUPERIORITY||LS Mean difference (Final Values)|-0.965|STANDARD_ERROR_OF_MEAN|2.6535||0.717|TWO_SIDED|95.0|-6.241|4.311|||ANCOVA|||Cerebrospinal Fluid Phosphorylated Tau Protein Immunoassay||4.311|-6.241|0.717
73968074|NCT03420833|147474256|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
73968075|NCT03420833|147474258|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
73968076|NCT03420833|147474258|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
73968077|NCT04927065|147474268|OTHER||Geometric Mean Ratio (GMR)|2.5|||||TWO_SIDED|95.0|2.0|3.0|||||Omicron BA.1 Variant (B.1.1.529) nAB: Part A.2 versus Part A.1|||3.0|2.0|
73968078|NCT04927065|147474268|OTHER||GMR|2.0|||||TWO_SIDED|95.0|1.7|2.3|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||2.3|1.7|
73968079|NCT04927065|147474269|OTHER||Geometric Mean Ratio (GMR)|6.3|||||TWO_SIDED|95.0|4.5|8.9|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||8.9|4.5|
73968080|NCT04927065|147474269|OTHER||GMR|2.8|||||TWO_SIDED|95.0|2.1|3.6|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||3.6|2.1|
74028534|NCT00641043|147610793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.103||||0.0051||95.0|1.25|3.539|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||3.539|1.25|0.0051
74028535|NCT00641043|147610795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.348||||0.3547||95.0|0.716|2.537|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||2.537|0.716|0.3547
74028536|NCT00641043|147610797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.823|||<|0.0001||95.0|2.286|6.394|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||6.394|2.286|<0.0001
73861846|NCT02008357|147269537|SUPERIORITY||LS Mean difference (Final Values)|12738.449|STANDARD_ERROR_OF_MEAN|998.7048|<|0.001|TWO_SIDED|95.0|10757.047|14719.851|||ANCOVA|||Cerebrospinal Fluid Amyloid Beta 1-40 Modified ELISA - INNOTEST||14719.851|10757.047|<0.001
73968081|NCT04927065|147474270|OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-3.1|5.6|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||5.6|-3.1|
73968082|NCT04927065|147474270|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||||
73968083|NCT04927065|147474271|OTHER||Percentage Difference|-1.3|||||TWO_SIDED|95.0|-6.9|4.3|||||Omicron variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||4.3|-6.9|
73968084|NCT04927065|147474271|OTHER||Percentage Difference|-2.6|||||TWO_SIDED|95.0|-9.6|4.5|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||4.5|-9.6|
73968085|NCT04927065|147474272|OTHER||Percentage Difference|12.9|||||TWO_SIDED|95.0|4.1|21.6|||||Omicron BA.1 variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||21.6|4.1|
73968086|NCT04927065|147474272|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||||
73968087|NCT04927065|147474273|OTHER||Percentage Difference|2.9|||||TWO_SIDED|95.0|-11.4|17.1|||||Omicron BA.1 variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||17.1|-11.4|
74028537|NCT00474630|147610798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.28|||<|0.001||95.0|-4.34|-2.22|||ANCOVA|||||-2.22|-4.34|<0.001
74028538|NCT00474630|147610799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||ANCOVA|||||-0.27|-0.71|<0.001
74028539|NCT00474630|147610800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.001|TWO_SIDED|95.0|2.15|5.5|||Regression, Logistic|||||5.50|2.15|<0.001
74028540|NCT00474630|147610801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.4||||0.007|TWO_SIDED||||||ANCOVA|||||||0.007
74028541|NCT00474630|147610802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.32|||<|0.001|TWO_SIDED|95.0|1.8|4.84|||ANCOVA|||||4.84|1.80|<0.001
74028542|NCT00474630|147610803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.85||||0.065|TWO_SIDED|95.0|-16.21|0.5|||ANCOVA|||||0.50|-16.21|0.065
74028543|NCT00474630|147610804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.08|||||TWO_SIDED|95.0|-3.57|-0.59||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.59|-3.57|
73923829|NCT00975481|147376557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3982||||0.3482|TWO_SIDED|95.0|-7.0337|19.8301|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||19.8301|-7.0337|0.3482
73923830|NCT00975481|147376557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.3031|||<|0.0001|TWO_SIDED|95.0|-60.4869|-34.1193|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-34.1193|-60.4869|<0.0001
73968088|NCT04927065|147474273|OTHER||Percentage Difference|-7.1|||||TWO_SIDED|95.0|-21.6|7.3|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||7.3|-21.6|
73968089|NCT04927065|147474274|OTHER||GMR|1.777|||||TWO_SIDED|95.0|1.523|2.073|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.073|1.523|
73968090|NCT04927065|147474275|OTHER||Percentage Difference|0.6|||||TWO_SIDED|95.0|-1.7|3.0|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||3.0|-1.7|
73968091|NCT04927065|147474276|OTHER||Percentage Difference|17.9|||||TWO_SIDED|95.0|9.8|26.0|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||26.0|9.8|
73968092|NCT04927065|147474277|OTHER||GMR|1.744|||||TWO_SIDED|97.5|1.492|2.04|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.040|1.492|
73968093|NCT04927065|147474277|OTHER||GMR|1.211|||||TWO_SIDED|97.5|1.074|1.366|||||SARS-CoV-2 (D614G) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||1.366|1.074|
73861847|NCT02008357|147269537|SUPERIORITY||LS Mean difference (Final Values)|996.411|STANDARD_ERROR_OF_MEAN|60.7404|<|0.001|TWO_SIDED|95.0|875.873|1116.948||p-value using ANCOVA model for endpoint measures: CHG = Baseline + APOE4 + AGE + Treatment.|ANCOVA|||Cerebrospinal Fluid Amyloid Beta 1-42 Mod Modified ELISA - INNOTEST||1116.948|875.873|<0.001
73968094|NCT04927065|147474278|OTHER||GMR|1.676|||||TWO_SIDED|97.5|1.396|2.013|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.013|1.396|
73968095|NCT04927065|147474278|OTHER||GMR|1.105|||||TWO_SIDED|97.5|0.97|1.26|||||SARS-CoV-2 (D614G) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||1.260|0.970|
73968096|NCT04927065|147474279|OTHER||Percentage Difference|1.5|||||TWO_SIDED|97.5|-1.1|4.1|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||4.1|-1.1|
73968097|NCT04927065|147474280|OTHER||Percentage Difference|21.5|||||TWO_SIDED|97.5|12.8|30.2|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||30.2|12.8|
73968098|NCT04927065|147474281|OTHER||Percentage Difference|1.8|||||TWO_SIDED|97.5|-1.9|5.6|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||5.6|-1.9|
73968099|NCT04927065|147474282|OTHER||Percentage Difference|20.6|||||TWO_SIDED|97.5|12.4|28.7|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||28.7|12.4|
73968100|NCT04927065|147474283|OTHER||GMR|6.412|||||TWO_SIDED|95.0|5.369|7.658|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||7.658|5.369|
73968101|NCT04927065|147474283|OTHER||GMR|1.967|||||TWO_SIDED|95.0|1.708|2.265|||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.265|1.708|
73968102|NCT04927065|147474284|OTHER||Percentage Difference|12.2|||||TWO_SIDED|95.0|6.9|17.4|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||17.4|6.9|
73968103|NCT04927065|147474284|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||||
73968104|NCT04927065|147474285|OTHER||Percentage Difference|54.7|||||TWO_SIDED|95.0|47.5|61.8|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||61.8|47.5|
73968105|NCT04927065|147474285|OTHER||Percentage Difference|37.6|||||TWO_SIDED|95.0|29.3|45.9|||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||45.9|29.3|
73968106|NCT04927065|147474294|OTHER||GMR|0.836|||||TWO_SIDED|95.0|0.745|0.938|||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||0.938|0.745|
73968107|NCT04927065|147474295|OTHER||SRR Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg 95% CI could not be calculated due to the SRR difference is 0.|||||
73968108|NCT04927065|147474296|OTHER||SRR Difference|-13.1|||||TWO_SIDED|95.0|-21.2|-5.0|||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||-5.0|-21.2|
73968109|NCT04927065|147474297|OTHER||SRR Difference|0.0|||||TWO_SIDED|97.5|||||||SARS-CoV-2 (D614G) nAb at Day 29: Part G versus Part F (Cohort 2) mRNA-1273 95% CI could not be calculated due to the SRR difference is 0.|||||
73968110|NCT04927065|147474297|OTHER||SRR Difference|0.9|||||TWO_SIDED|97.5|-1.6|3.5|||||SARS-CoV-2 (D614G) nAb at Day 91: Part G versus Part F (Cohort 2) mRNA-1273|||3.5|-1.6|
73968111|NCT04927065|147474297|OTHER||SRR Difference|-0.1|||||TWO_SIDED|95.0|-2.3|2.1|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||2.1|-2.3|
73968112|NCT04927065|147474297|OTHER||SRR Difference|-1.9|||||TWO_SIDED|95.0|-5.3|1.5|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.5|-5.3|
73968113|NCT04927065|147474298|OTHER||SRR Difference|10.9|||||TWO_SIDED|97.5|1.7|20.1|||||SARS-CoV-2 (D614G) nAb at Day 29: Part G versus Part F (Cohort 2) mRNA-1273|||20.1|1.7|
73968114|NCT04927065|147474298|OTHER||SRR Difference|9.2|||||TWO_SIDED|97.5|1.4|17.0|||||SARS-CoV-2 (D614G) nAb at Day 91: Part G versus Part F (Cohort 2) mRNA-1273|||17.0|1.4|
73923831|NCT00975481|147376557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.1672|||<|0.0001|TWO_SIDED|95.0|-64.4276|-37.9069|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-37.9069|-64.4276|<0.0001
73923832|NCT00975481|147376557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.2062|||<|0.0001|TWO_SIDED|95.0|-53.589|-26.8234|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.8234|-53.5890|<0.0001
73923833|NCT00975481|147376557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.421|||<|0.0001|TWO_SIDED|95.0|-64.3974|-38.4445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-38.4445|-64.3974|<0.0001
73923834|NCT00975481|147376557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.2851|||<|0.0001|TWO_SIDED|95.0|-68.3904|-42.1798|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-42.1798|-68.3904|<0.0001
73923835|NCT00975481|147376557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.3241|||<|0.0001|TWO_SIDED|95.0|-57.5825|-31.0656|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-31.0656|-57.5825|<0.0001
73923836|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.3823|||<|0.0001|TWO_SIDED|95.0|-62.1244|-30.6401|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI was obtained from the model.||-30.6401|-62.1244|<0.0001
73923837|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.5199|||<|0.0001|TWO_SIDED|95.0|-67.2633|-35.7765|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.7765|-67.2633|<0.0001
73923838|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0366||||0.4524|TWO_SIDED|95.0|-9.7924|21.8657|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||21.8657|-9.7924|0.4524
73923839|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4423||||0.762|TWO_SIDED|95.0|-13.4599|18.3446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.3446|-13.4599|0.7620
73923840|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1573||||0.9846|TWO_SIDED|95.0|-15.8609|16.1754|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.1754|-15.8609|0.9846
74087042|NCT03919448|147728127|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|95.73||||0.3617|TWO_SIDED|90.0|84.82|108.05|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||108.05|84.82|0.3617
73923841|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.4189|||<|0.0001|TWO_SIDED|95.0|36.7157|68.1221|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||68.1221|36.7157|<0.0001
73968115|NCT04927065|147474298|OTHER||SRR Difference|10.1|||||TWO_SIDED|95.0|3.0|17.2|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||17.2|3.0|
73968116|NCT04927065|147474298|OTHER||SRR Difference|4.3|||||TWO_SIDED|95.0|-5.0|13.6|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||13.6|-5.0|
73861848|NCT02008357|147269538|SUPERIORITY||LS Mean difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.0388||0.161|TWO_SIDED|95.0|-0.131|0.022|||ANCOVA|||Total hippocampal volume||0.022|-0.131|0.161
73861849|NCT02008357|147269538|SUPERIORITY||LS Mean difference (Final Values)|0.351|STANDARD_ERROR_OF_MEAN|0.4513||0.437|TWO_SIDED|95.0|-0.535|1.236|||ANCOVA|||Total Lateral Ventricular Volume||1.236|-0.535|0.437
73968117|NCT04927065|147474300|OTHER||GMR|1.818|||||TWO_SIDED|95.0|1.469|2.249|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||2.249|1.469|
73861850|NCT02945553|147269546|OTHER|Mixed model analysis of variance|Mean Difference (Final Values)|1596.0|STANDARD_DEVIATION|202.0|<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73861851|NCT02945553|147269551|OTHER||Mean Difference (Net)|30.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73968118|NCT04927065|147474302|OTHER||SRR Difference|0.0|||||TWO_SIDED|95.0|-2.6|2.5|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||2.5|-2.6|
73861852|NCT03553498|147269552|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
73861853|NCT03553498|147269553|SUPERIORITY|||||||0.989|||||||Chi-squared|||||||0.989
73861854|NCT03553498|147269554|SUPERIORITY|||||||0.414|||||||Chi-squared|||||||0.414
73923842|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.8246|||<|0.0001|TWO_SIDED|95.0|33.0228|64.6264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||64.6264|33.0228|<0.0001
73968119|NCT04927065|147474304|OTHER||SRR Difference|25.5|||||TWO_SIDED|95.0|16.9|34.1|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||34.1|16.9|
73923843|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.5395|||<|0.0001|TWO_SIDED|95.0|30.5968|62.4823|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||62.4823|30.5968|<0.0001
73923844|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|57.5565|||<|0.0001|TWO_SIDED|95.0|42.0679|73.0451|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||73.0451|42.0679|<0.0001
73968120|NCT04927065|147474305|OTHER||SRR Difference|5.0|||||TWO_SIDED|95.0|0.3|9.8|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||9.8|0.3|
73968121|NCT04927065|147474305|OTHER||SRR Difference|5.6|||||TWO_SIDED|95.0|-0.3|11.5|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||11.5|-0.3|
73968122|NCT04927065|147474306|OTHER||SRR Difference|14.5|||||TWO_SIDED|95.0|6.7|22.3|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||22.3|6.7|
73968123|NCT04927065|147474306|OTHER||SRR Difference|8.0|||||TWO_SIDED|95.0|-2.1|18.0|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||18.0|-2.1|
73861855|NCT03553498|147269555|SUPERIORITY|||||||0.153|||||||Chi-squared|||||||0.153
73968124|NCT04927065|147474307|OTHER||GMR|1.637|||||TWO_SIDED|95.0|1.243|2.155|||||SARS-CoV-2 (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||2.155|1.243|
73968125|NCT04927065|147474307|OTHER||GMR|1.373|||||TWO_SIDED|95.0|0.953|1.976|||||SARS-CoV-2 (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.976|0.953|
73968126|NCT04927065|147474307|OTHER||GMR|1.271|||||TWO_SIDED|95.0|1.051|1.537|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||1.537|1.051|
73968127|NCT04927065|147474307|OTHER||GMR|1.101|||||TWO_SIDED|95.0|0.83|1.461|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.461|0.830|
73968128|NCT03378570|147474354|OTHER|comparative effectiveness trial||||||0.945|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.945
73968129|NCT03378570|147474355|OTHER|comparative effectiveness trial||||||0.828|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.828
73968130|NCT03378570|147474356|OTHER|comparative effectiveness trial||||||0.252|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.252
74028544|NCT00474630|147610805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75|||||TWO_SIDED|95.0|1.79|7.88||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||7.88|1.79|
74028545|NCT00474630|147610806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||||TWO_SIDED|95.0|1.5|4.04||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.04|1.50|
73861856|NCT02741570|147269558|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0469|TWO_SIDED|97.51|0.59|1.03|||Log Rank|stratified regular log-rank test||||1.03|0.59|0.0469
73861857|NCT02741570|147269559|SUPERIORITY||Cox Proportional Hazard|0.95||||0.4951|TWO_SIDED|97.9|0.8|1.13|||Log Rank|stratified regular log-rank test||||1.13|0.80|0.4951
73861858|NCT02741570|147269560|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|0.68|0.95||||||||0.95|0.68|
73861859|NCT02741570|147269561|SUPERIORITY||Cox Proportional Hazard|1.4|||||TWO_SIDED|95.0|1.19|1.63|||||All Randomized Participants|||1.63|1.19|
73861860|NCT02741570|147269561|SUPERIORITY||Cox Proportional Hazard|1.0|||||TWO_SIDED|95.0|0.77|1.3|||||All Randomized PD-L1 CPS \>= 20 Participants|||1.30|0.77|
73861861|NCT02741570|147269564|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||||0.97|0.60|
73861862|NCT02741570|147269565|SUPERIORITY||Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.82|1.08||||||||1.08|0.82|
73861863|NCT03343080|147269591|SUPERIORITY|||||||0.776|||||||Wilcoxon (Mann-Whitney)|||||||0.776
73861864|NCT03343080|147269592|SUPERIORITY|||||||0.296|||||||t-test, 2 sided|||4 hours post-extubation||||0.296
73861865|NCT01241760|147269593|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% confidence interval of the difference in proportions was above the pre-determined non-inferiority margin of -11%, non-inferiority was established.|Difference in proportion of response, %|1.5||||||95.0|-4.9|12.0|||Regression, Logistic|The 95% confidence interval of the difference in proportions was estimated using a logistic regression model.|Observed data|||12|-4.9|
73968131|NCT03378570|147474357|OTHER|||||||0.505||||||p value for response rate|Chi-squared|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.505
73968132|NCT03378570|147474357|OTHER|||||||0.888||||||p value for remission rate|Chi-squared|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.888
73968133|NCT03378570|147474358|OTHER|||||||0.994|||||||Chi-squared|p value for response rates||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.994
73968134|NCT03378570|147474358|OTHER|||||||0.911|||||||Chi-squared|p value for remission rates||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.911
73968135|NCT03378570|147474359|OTHER|||||||0.778|||||||t-test, 2 sided|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.778
73968136|NCT03378570|147474360|OTHER|comparative effectiveness trial||||||0.951|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||.951
73968137|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.278|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Positive Affect.||||.278
73968138|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.024|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, General Life Satisfaction.||||.024
73968139|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.439|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Meaning \& Purpose.||||.439
73968140|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.025|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Emotional Support.||||.025
73968141|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.007|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Instrumental Support.||||.007
74028546|NCT00474630|147610807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.35|0.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.86|0.35|
74028547|NCT00474630|147610808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|0.27|7.57||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||7.57|0.27|
74087043|NCT03919448|147728128|EQUIVALENCE|80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|90.46||||0.3529|TWO_SIDED|90.0|80.64|101.47||Power of ANOVA: 0.94|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||101.47|80.64|0.3529
73968142|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.014|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Friendship.||||.014
73968143|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.398|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Loneliness.||||.398
73968144|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.064|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Rejection.||||.064
73968145|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.368|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Hostility.||||.368
73968146|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.504|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Self-Efficacy.||||.504
73968147|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.371|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Stress.||||.371
73968148|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.438|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Affect.||||.438
74028548|NCT00474630|147610809|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|0.55|12.67||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||12.67|0.55|
74028549|NCT00474630|147610810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.89|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
74028550|NCT00474630|147610811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.13|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
74087044|NCT03919448|147728128|EQUIVALENCE|80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|95.02||||0.3529|TWO_SIDED|90.0|84.8|106.49||Power of ANOVA: 0.94|ANOVA|||||106.49|84.80|0.3529
74087045|NCT03919448|147728128|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|95.19||||0.3529|TWO_SIDED|90.0|84.17|107.67|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||107.67|84.17|0.3529
73923845|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.9622|||<|0.0001|TWO_SIDED|95.0|38.3293|69.5952|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||69.5952|38.3293|<0.0001
73923846|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.6772|||<|0.0001|TWO_SIDED|95.0|35.866|67.4884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||67.4884|35.8660|<0.0001
73923847|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.4454||||0.0003|TWO_SIDED|95.0|17.7051|57.1857|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||57.1857|17.7051|0.0003
73923848|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.6714|||<|0.0001|TWO_SIDED|95.0|22.2888|61.054|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||61.0540|22.2888|<0.0001
73923849|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.7583||||0.0744|TWO_SIDED|95.0|-37.2956|1.7789|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.7789|-37.2956|0.0744
73968149|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.096|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Somatic Arousal.||||.096
73968150|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.132|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Sadness.||||.132
73968151|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.951|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Affect.||||.951
73861866|NCT01636713|147269609|SUPERIORITY_OR_OTHER||Least squares mean difference|0.151|||<|0.001|TWO_SIDED|95.0|0.11|0.191|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.191|0.110|<0.001
73968152|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.852|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Hostility.||||.852
73968153|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.083|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Physical Aggression.||||.083
73968154|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.391|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Negative Affect.||||.391
73968155|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.014|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Social Satisfaction.||||.014
73923850|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5551||||0.3458|TWO_SIDED|95.0|-29.5573|10.4471|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||10.4471|-29.5573|0.3458
73923851|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.792||||0.9375|TWO_SIDED|95.0|-19.1777|20.7616|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||20.7616|-19.1777|0.9375
73923852|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.2037|||<|0.0001|TWO_SIDED|95.0|-74.8113|-35.5961|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.5961|-74.8113|<0.0001
73923853|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.0005|||<|0.0001|TWO_SIDED|95.0|-67.002|-26.9989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.9989|-67.0020|<0.0001
73923854|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.6534||||0.0004|TWO_SIDED|95.0|-56.7246|-16.5822|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.5822|-56.7246|0.0004
73923855|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-59.4297|||<|0.0001|TWO_SIDED|95.0|-78.5162|-40.3433|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-40.3433|-78.5162|<0.0001
73923856|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.2265|||<|0.0001|TWO_SIDED|95.0|-70.8131|-31.6399|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-31.6399|-70.8131|<0.0001
73923857|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8794||||0.0001|TWO_SIDED|95.0|-60.4726|-21.2862|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-21.2862|-60.4726|0.0001
73923858|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.5197||||0.0102|TWO_SIDED|95.0|5.7096|41.3298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.3298|5.7096|0.0102
73923859|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.7321||||0.0021|TWO_SIDED|95.0|10.3632|45.1011|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||45.1011|10.3632|0.0021
73923860|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7334||||0.5935|TWO_SIDED|95.0|-22.2807|12.814|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||12.8140|-22.2807|0.5935
74087046|NCT01652729|147728135|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.2167||0.001|TWO_SIDED|95.0|-1.15|-0.3|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.30|-1.15|0.0010
73861867|NCT01636713|147269609|SUPERIORITY_OR_OTHER||Least squares mean difference|0.216|||<|0.001|TWO_SIDED|95.0|0.175|0.257|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference= UMEC/VI 125/25 µg minus Placebo.|||0.257|0.175|<0.001
73923861|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5486||||0.6945|TWO_SIDED|95.0|-14.3397|21.437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||21.4370|-14.3397|0.6945
73923862|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2936||||0.4177|TWO_SIDED|95.0|-10.4975|25.0847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||25.0847|-10.4975|0.4177
73923863|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.2531||||0.0019|TWO_SIDED|95.0|-45.802|-10.7042|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.7042|-45.8020|0.0019
73923864|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9711||||0.0299|TWO_SIDED|95.0|-37.9541|-1.988|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.9880|-37.9541|0.0299
73923865|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2261||||0.0759|TWO_SIDED|95.0|-34.1785|1.7264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.7264|-34.1785|0.0759
73923866|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.4655||||0.0002|TWO_SIDED|95.0|-49.2278|-15.7032|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.7032|-49.2278|0.0002
73923867|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1835||||0.0069|TWO_SIDED|95.0|-41.5832|-6.7838|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.7838|-41.5832|0.0069
73923868|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4385||||0.0222|TWO_SIDED|95.0|-37.8861|-2.991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.9910|-37.8861|0.0222
73923869|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.589||||0.0002|TWO_SIDED|95.0|12.0126|37.1654|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||37.1654|12.0126|0.0002
73923870|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.11|||<|0.0001|TWO_SIDED|95.0|16.4903|41.7298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.7298|16.4903|<0.0001
73923871|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6428||||0.6809|TWO_SIDED|95.0|-10.0309|15.3165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||15.3165|-10.0309|0.6809
73923872|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3215||||0.6067|TWO_SIDED|95.0|-16.0415|9.3985|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||9.3985|-16.0415|0.6067
73861868|NCT03780959|147269612|SUPERIORITY|||||||0.003|||||||Mantel Haenszel|Stratified by study center and the number of active joints at randomization||||||0.0030
73861869|NCT03780959|147269613|SUPERIORITY|||||||0.0001|||||||Log Rank|||||||0.0001
73923873|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4722||||0.3999|TWO_SIDED|95.0|-7.335|18.2795|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.2795|-7.3350|0.3999
73923874|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.9461||||0.0007|TWO_SIDED|95.0|-34.5327|-9.3596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.3596|-34.5327|0.0007
74087047|NCT01652729|147728135|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1638||0.0209|TWO_SIDED|95.0|-0.7|-0.06|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.06|-0.70|0.0209
74087048|NCT01652729|147728135|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2278||0.1347|TWO_SIDED|95.0|-0.79|0.11|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||0.11|-0.79|0.1347
74087049|NCT01652729|147728136|SUPERIORITY_OR_OTHER|||||||0.0489|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c \<7% at Week 28.||||0.0489
74087050|NCT01652729|147728136|SUPERIORITY_OR_OTHER|||||||0.0103|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c \<7% at Week 28.||||0.0103
73923875|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.9105|||<|0.0001|TWO_SIDED|95.0|-40.564|-15.257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.2570|-40.5640|<0.0001
73923876|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1168||||0.0036|TWO_SIDED|95.0|-31.8907|-6.3428|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.3428|-31.8907|0.0036
73923877|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.4672|||<|0.0001|TWO_SIDED|95.0|-38.8298|-14.1046|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.1046|-38.8298|<0.0001
73923878|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.4315|||<|0.0001|TWO_SIDED|95.0|-44.925|-19.938|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.9380|-44.9250|<0.0001
73968156|NCT03378570|147474361|OTHER|comparative effectiveness trial||||||0.109|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Psychological Well Being.||||.109
74087051|NCT01652729|147728137|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|5.96||0.0924|TWO_SIDED|95.0|-21.8|1.7|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||1.7|-21.8|0.0924
73968157|NCT03378570|147474362|SUPERIORITY|||||||0.231||||||Week 6 timepoint p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~First Visit p = 0.875 Week 1 p = 0.084 Week 2 p = 0.277 Week 3 p = 0.686 Week 4 p = 0.369 Week 5 p = 0.806"||||||0.231
73968158|NCT03378570|147474363|SUPERIORITY|||||||0.963||||||Week 6-7 Follow-up p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~Evaluation p = 0.570 Week 2-3 Follow-up p = 0.063 Week 4-5 Follow-up p = 0.792"||||||0.963
73968159|NCT03378570|147474364|SUPERIORITY|||||||0.051||||||Week 6 timepoint p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~First Visit p = 0.772 Week 1 p = 0.194 Week 2 p = 0.127 Week 3 p = 0.196 Week 4 p = 0.079 Week 5 p = 0.187"||||||0.051
73968160|NCT03443323|147474373|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (OTMP skills \[COSS-P, COSS-T\]).|Mixed Models Analysis|||||||<.001
73968161|NCT03443323|147474374|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (OTMP skills \[COSS-P, COSS-T\]).|Mixed Models Analysis|||||||<.001
73968162|NCT03443323|147474375|SUPERIORITY|||||||0.007||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (homework performance \[HPC, HPQ-T\]).|Mixed Models Analysis|||||||0.007
73968163|NCT03443323|147474376|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (homework performance \[HPC, HPQ-T\]).|Mixed Models Analysis|||||||<.001
73861870|NCT03689244|147269637|SUPERIORITY||Ratio of Geometric LS mean|0.95||||0.412|TWO_SIDED|95.0|0.84|1.07|||ANCOVA|||Ratio of Geometric mean of Selexipag to Placebo was reported.||1.07|0.84|0.412
73861871|NCT02700165|147269639|OTHER||sucess proportion|78.6|||||TWO_SIDED|95.0|49.2|95.3|||||Independent physician reviewers correctly identified 13/14, 11/14 and 10/14, respectively for an overall percentage of correct identification of 34/42 or 81%. Two of three reviewers correctly identified 11/14 (78.6%) photos.|||95.3|49.2|
73861872|NCT02011490|147269643|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|5.42|||||TWO_SIDED|90.0|4.12|7.11|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an analysis of variance (ANOVA) linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||7.11|4.12|
73861873|NCT02011490|147269643|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|2.42|||||TWO_SIDED|90.0|1.84|3.17|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||3.17|1.84|
73861874|NCT02011490|147269644|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|5.49|||||TWO_SIDED|90.0|4.18|7.22|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||7.22|4.18|
73861875|NCT02011490|147269644|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|2.42|||||TWO_SIDED|90.0|1.84|3.18|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||3.18|1.84|
73923879|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.6378||||0.0003|TWO_SIDED|95.0|-36.2802|-10.9954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.9954|-36.2802|0.0003
73923880|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6675||||0.9728|TWO_SIDED|95.0|-39.708|41.043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.0430|-39.7080|0.9728
73923881|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.7977||||0.0246|TWO_SIDED|95.0|6.1059|79.4894|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||79.4894|6.1059|0.0246
73861876|NCT02011490|147269645|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|90.0|0.73|1.21|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||1.21|0.73|
73861877|NCT02011490|147269645|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.92|||||TWO_SIDED|90.0|0.72|1.18|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||1.18|0.72|
73861878|NCT03697993|147269663|OTHER||Risk Difference (RD)|-18.0||||0.264|TWO_SIDED|95.0|-43.4|8.7|||Multiple imputation using Wald method|||||8.7|-43.4|0.264
73861879|NCT03697993|147269667|OTHER||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-26.2|24.3|||Fisher Exact|||||24.3|-26.2|1.000
73861880|NCT03697993|147269668|OTHER||Odds Ratio (OR)|0.9||||0.894|TWO_SIDED|95.0|0.3|2.5|||Proportional odds model using Wald test|||||2.5|0.3|0.894
73861881|NCT03697993|147269669|OTHER||Risk Difference (RD)|0.0||||0.973|TWO_SIDED|95.0|-26.3|25.3|||Multiple imputation using Wald method|||||25.3|-26.3|0.973
73861882|NCT02698371|147269672|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance between baseline and 24 month follow-up;||||0.025
73861883|NCT02698371|147269672|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.189
73861884|NCT02698371|147269672|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;||||0.189
73861885|NCT02698371|147269672|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance from baseline to 24 month follow-up;||||0.025
73861886|NCT02698371|147269672|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.747
73861887|NCT02698371|147269672|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;||||0.747
73861888|NCT02698371|147269672|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.070
73861889|NCT02698371|147269672|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional-FDI comparison between G1G2 and G3G4 and G5G6 Arms success rate from baseline to 24 month recall. For Esthetic and Biological-FDI comparison p values were \> 0.05. Adjusted P-values.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;||||0.070
73861890|NCT02698371|147269672|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms retention rate from baseline to 24 month recall. Adjusted P-values.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;||||0.070
73861891|NCT02698371|147269673|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.025
73861892|NCT02698371|147269673|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.189
73861893|NCT02698371|147269673|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;||||0.189
73861894|NCT02698371|147269673|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.025
73861895|NCT02698371|147269673|EQUIVALENCE|alpha value of 0.05 was considered||||||0.154|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.154
73861896|NCT02698371|147269673|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;||||0.747
73861897|NCT02698371|147269673|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.070
73861898|NCT02698371|147269673|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;||||0.070
73923882|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5411||||0.7068|TWO_SIDED|95.0|-33.785|48.8672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||48.8672|-33.7850|0.7068
73968164|NCT03443323|147474377|SUPERIORITY||||||<|0.06||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (academic performance \[ACES, APS\]).|Mixed Models Analysis|||||||<.06
73861899|NCT02698371|147269673|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;||||0.070
73861900|NCT02698371|147269674|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Esthetic of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Esthetic outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||1.000
73861901|NCT02698371|147269674|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Functional outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||1.000
73861902|NCT02698371|147269674|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.998||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Biologic FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Biological outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||0.998
73861903|NCT02698371|147269675|EQUIVALENCE|alpha value of 0.05 was considered||||||0.029||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Luster Performance at 24 Month Follow-up recall.||||0.029
73861904|NCT02698371|147269675|EQUIVALENCE|alpha value of 0.05 was considered||||||0.002||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall;||||0.002
74028551|NCT00474630|147610812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64|||||TWO_SIDED|95.0|1.36|5.14||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||5.14|1.36|
74028552|NCT00474630|147610813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37|||||TWO_SIDED|95.0|-0.77|3.51||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.51|-0.77|
74028553|NCT00474630|147610814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.62|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
74028554|NCT00474630|147610816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.98|||||TWO_SIDED|95.0|-9.22|-0.74||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.74|-9.22|
74087052|NCT01652729|147728137|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.9|STANDARD_ERROR_OF_MEAN|8.037||0.0001|TWO_SIDED|95.0|-46.7|-15.1|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-15.1|-46.7|0.0001
73861905|NCT02698371|147269675|EQUIVALENCE|alpha value of 0.05 was considered||||||0.618||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall.||||0.618
73861906|NCT02698371|147269676|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.009||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.||||0.009
73861907|NCT02698371|147269676|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.059||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.||||0.059
73923883|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7069||||0.5492|TWO_SIDED|95.0|-26.0358|47.4496|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||47.4496|-26.0358|0.5492
73923884|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1248||||0.5899|TWO_SIDED|95.0|-31.3098|53.5595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||53.5595|-31.3098|0.5899
73923885|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8736||||0.6998|TWO_SIDED|95.0|-29.8691|43.6163|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||43.6163|-29.8691|0.6998
73923886|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0394||||0.6187|TWO_SIDED|95.0|-31.4818|51.5606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||51.5606|-31.4818|0.6187
73923887|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4573||||0.5863|TWO_SIDED|95.0|-29.0355|49.9502|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||49.9502|-29.0355|0.5863
74028555|NCT00474630|147610817|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.43|||||TWO_SIDED|95.0|-7.48|4.62||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.62|-7.48|
74087053|NCT01652729|147728138|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.4058||0.8625|TWO_SIDED|95.0|-0.73|0.87||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||0.87|-0.73|0.8625
73861908|NCT02698371|147269676|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.829||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Staining Margin performance at 24 month follow-up recall.||||0.829
73861909|NCT02698371|147269677|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) Colour Stability-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||<0.001
73861910|NCT02698371|147269677|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||<0.001
73968165|NCT03443323|147474378|SUPERIORITY||||||>|0.0083||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (academic performance \[ACES, APS\]).|Mixed Models Analysis|||||||>.0083
73968166|NCT03443323|147474379|SUPERIORITY||||||>|0.05||||||Statistical significance was evaluated using a threshold p value of .05.|Mixed Models Analysis|||||||>.05
74028556|NCT00474630|147610818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|||||TWO_SIDED|95.0|-1.02|3.33||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.33|-1.02|
73861911|NCT02698371|147269677|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.064||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||0.064
73923888|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.2566||||0.0832|TWO_SIDED|95.0|-75.608|5.0948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.0948|-75.6080|0.0832
73923889|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.0907||||0.0827|TWO_SIDED|95.0|-68.7519|4.5704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.5704|-68.7519|0.0827
73923890|NCT00975481|147376558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.6728||||0.1386|TWO_SIDED|95.0|-74.5352|11.1895|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.1895|-74.5352|0.1386
73923891|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3637||||0.1691|TWO_SIDED|95.0|-0.1566|0.884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.8840|-0.1566|0.1691
73923892|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8444||||0.0017|TWO_SIDED|95.0|0.3238|1.365|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.3650|0.3238|0.0017
73923893|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2093||||0.4305|TWO_SIDED|95.0|-0.3141|0.7327|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.7327|-0.3141|0.4305
73968167|NCT03443323|147474380|SUPERIORITY||||||>|0.05||||||Statistical significance was evaluated using a threshold p value of .05.|Mixed Models Analysis|||||||>.05
74028557|NCT00474630|147610819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||||TWO_SIDED|95.0|-1.04|1.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.86|-1.04|
74028558|NCT00474630|147610820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.62|||||TWO_SIDED|95.0|0.59|2.65||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.65|0.59|
73923894|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1206||||0.6517|TWO_SIDED|95.0|-0.4064|0.6476|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.6476|-0.4064|0.6517
73923895|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0374||||0.8892|TWO_SIDED|95.0|-0.5666|0.4919|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.4919|-0.5666|0.8892
73923896|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1544||||0.5576|TWO_SIDED|95.0|-0.6737|0.3649|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.3649|-0.6737|0.5576
73923897|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2431||||0.3594|TWO_SIDED|95.0|-0.7658|0.2796|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.2796|-0.7658|0.3594
73923898|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4011||||0.1355|TWO_SIDED|95.0|-0.9291|0.127|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.1270|-0.9291|0.1355
73923899|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6351||||0.0153|TWO_SIDED|95.0|-1.1466|-0.1236|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.1236|-1.1466|0.0153
73968168|NCT04610892|147474406|SUPERIORITY||Least Square Mean difference|-8.3797||||0.065||90.0|-17.498|0.7387||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||0.7387|-17.4980|0.065
73968169|NCT04610892|147474406|SUPERIORITY||Least Square Mean difference|2.3915||||0.747||90.0|-3.5338|8.3167||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||8.3167|-3.5338|0.747
73968170|NCT04610892|147474406|SUPERIORITY||Least Square Mean difference|0.5766||||0.563||90.0|-5.4389|6.5921||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||6.5921|-5.4389|0.563
73968171|NCT04610892|147474406|SUPERIORITY||Least Square Mean difference|1.5204||||0.685||90.0|-3.6657|6.7064||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||6.7064|-3.6657|0.685
73968172|NCT04610892|147474407|SUPERIORITY||Geometric LS mean ratio estimate|1.12||||0.854||90.0|0.94|1.33||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.33|0.94|0.854
74028559|NCT00474630|147610821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43|||||TWO_SIDED|95.0|-0.42|1.27||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.27|-0.42|
74028560|NCT00474630|147610822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|||||TWO_SIDED|96.0|-0.76|0.85||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.85|-0.76|
74028561|NCT03088605|147610839|SUPERIORITY||Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|90.0|-0.7|0.0|||ANCOVA|||Change from Baseline. ANCOVA model includes baseline scores as a covariate||0|-0.7|0.02
74028562|NCT03088605|147610840|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0001|TWO_SIDED|90.0|-1.4|0.5|||ANCOVA|||Change form baseline. ANCOVA model includes baseline score as a covariate.||0.5|-1.4|0.0001
74028563|NCT03088605|147610841|SUPERIORITY||Mean Difference (Net)|-1.42||||0.03|TWO_SIDED|90.0|-2.36|-0.47|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||-0.47|-2.36|0.03
74028564|NCT03088605|147610842|SUPERIORITY||Mean Difference (Net)|0.199||||0.39|TWO_SIDED|90.0|-0.177|0.575|||ANCOVA|||Change from Baseline; ANCOVA model includes baseline score as a covariate.||0.575|-0.177|0.39
74087054|NCT01652729|147728138|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.5419||0.0198|TWO_SIDED|95.0|-2.34|-0.2||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.20|-2.34|0.0198
73923900|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7238||||0.0065|TWO_SIDED|95.0|-1.2418|-0.2059|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2059|-1.2418|0.0065
73923901|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8818||||0.0011|TWO_SIDED|95.0|-1.4042|-0.3594|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.3594|-1.4042|0.0011
73923902|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1614|||<|0.0001|TWO_SIDED|95.0|-2.9373|-1.3856|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.3856|-2.9373|<0.0001
73923903|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0336|||<|0.0001|TWO_SIDED|95.0|-3.8085|-2.2587|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.2587|-3.8085|<0.0001
73923904|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2791||||0.4804|TWO_SIDED|95.0|-1.0586|0.5004|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.5004|-1.0586|0.4804
73923905|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.9519|TWO_SIDED|95.0|-0.7608|0.8087|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.8087|-0.7608|0.9519
73923906|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.497||||0.2152|TWO_SIDED|95.0|-1.286|0.2921|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.2921|-1.2860|0.2152
73923907|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8824|||<|0.0001|TWO_SIDED|95.0|1.1094|2.6553|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.6553|1.1094|<0.0001
73923908|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1854|||<|0.0001|TWO_SIDED|95.0|1.407|2.9638|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.9638|1.4070|<0.0001
73923909|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6645|||<|0.0001|TWO_SIDED|95.0|0.8786|2.4503|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.4503|0.8786|<0.0001
73923910|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7545|||<|0.0001|TWO_SIDED|95.0|1.9912|3.5179|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.5179|1.9912|<0.0001
73968173|NCT04610892|147474407|SUPERIORITY||Geometric LS mean ratio estimate|1.06||||0.79||90.0|0.94|1.18||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.18|0.94|0.790
73968174|NCT04610892|147474407|SUPERIORITY||Geometric LS mean ratio estimate|1.0||||0.498||90.0|0.89|1.12||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.12|0.89|0.498
73968175|NCT04610892|147474407|SUPERIORITY||Geometric LS mean ratio estimate|1.03||||0.678||90.0|0.93|1.13||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.13|0.93|0.678
73968176|NCT04610892|147474408|SUPERIORITY||Least Squares mean difference|-1.44||||0.99||90.0|-2.44|-0.43||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.43|-2.44|0.990
74028565|NCT03088605|147610843|SUPERIORITY||Mean Difference (Net)|0.2||||0.97|TWO_SIDED|90.0|-1.7|2.0|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||2.0|-1.7|0.97
74028566|NCT03088605|147610844|SUPERIORITY||Mean Difference (Net)|-0.23||||0.06|TWO_SIDED|90.0|-0.48|0.03|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||0.03|-0.48|0.06
73923911|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0576|||<|0.0001|TWO_SIDED|95.0|2.2858|3.8294|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.8294|2.2858|<0.0001
73923912|NCT00975481|147376559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5366|||<|0.0001|TWO_SIDED|95.0|1.7578|3.3155|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.3155|1.7578|<0.0001
73923913|NCT01895855|147376572|SUPERIORITY|The lower, two sided 95% confidence bound on protective efficacy must be \>/= 30%.|Vaccine Efficacy|90.3|||||ONE_SIDED|95.1|62.7||||||Confidence intervals for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.|||62.7|
73923914|NCT01895855|147376573|SUPERIORITY|The lower, two sided 95% confidence bound on protective efficacy must be \>/= 30%.|Vaccine Efficacy|79.5|||||ONE_SIDED|95.1|49.9||||||Confidence intervals for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.|||49.9|
73923915|NCT01895855|147376574|SUPERIORITY|||||||0.0073|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0073
73923916|NCT01895855|147376575|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenge 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
73923917|NCT01895855|147376576|SUPERIORITY||Vaccine Efficacy|84.5|||||TWO_SIDED|95.0|67.0|100.0|||||Confidence interval for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||100.0|67.0|
73923918|NCT01895855|147376577|SUPERIORITY||Vaccine Efficacy|50.8|||||TWO_SIDED|95.0|33.6|66.8|||||Confidence interval for protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||66.8|33.6|
73923919|NCT01895855|147376578|SUPERIORITY|||||||0.0025|||||||Fisher Exact|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0025
73968177|NCT04610892|147474408|SUPERIORITY||Least Squares mean difference|-0.21||||0.697||90.0|-0.87|0.45||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.45|-0.87|0.697
73968178|NCT04610892|147474408|SUPERIORITY||Least Squares mean difference|-0.42||||0.849||90.0|-1.08|0.25||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.25|-1.08|0.849
73968179|NCT04610892|147474408|SUPERIORITY||Least Squares mean difference|-0.31||||0.811||90.0|-0.89|0.27||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.27|-0.89|0.811
73923920|NCT01895855|147376579|SUPERIORITY|||||||0.0159|||||||Fisher Exact|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0159
73968180|NCT04610892|147474409|SUPERIORITY||Least Squares mean difference|-3.5||||0.972||90.0|-6.49|-0.5||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.50|-6.49|0.972
73968181|NCT04610892|147474409|SUPERIORITY||Least Squares mean difference|-1.1||||0.777||90.0|-3.49|1.3||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.30|-3.49|0.777
73968182|NCT04610892|147474409|SUPERIORITY||Least Squares mean difference|-0.32||||0.596||90.0|-2.54|1.89||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.89|-2.54|0.596
73968183|NCT04610892|147474409|SUPERIORITY||Least Squares mean difference|-0.63||||0.698||90.0|-2.64|1.38||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.38|-2.64|0.698
73923921|NCT01895855|147376580|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
73923922|NCT01895855|147376581|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
73923923|NCT01895855|147376582|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
73923924|NCT01895855|147376583|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
73923925|NCT03642717|147376636|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in Glycosylated hemoglobin (HbA1c) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
73923926|NCT03642717|147376639|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in Fasting Plasma Glucose (FPG) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
73923927|NCT03642717|147376640|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in body weight at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
73923928|NCT03642717|147376641|OTHER|||||||0.0076||||||Paired t-test was applied comparing the difference in mean of change in systolic blood pressure (SBP) at Last Visit versus at Baseline.|Paired t-test|||||||0.0076
74028567|NCT00958568|147610850|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||Power estimate assumes approximately 1230 participants enter SPII. With a 60% drop-out/disqualification rate in SPII, then 492 participants enter SPIII. If 26% of participants drop out during SPIII, then 364 participants enter SPIV. Assuming 20% drop-out rate, 25% relapse rate on OFC and 40% relapse rate for fluoxetine (hazard ratio = 0.56), the log-rank test is 80% powered to detect a difference at a 2-sided 0.05 level. A total of 95 relapse events during SPIV should satisfy these assumptions.||||<0.001
74028568|NCT00958568|147610851|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
74028569|NCT00958568|147610852|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
74028570|NCT00958568|147610853|SUPERIORITY_OR_OTHER|||||||0.713||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||0.713
74028571|NCT00958568|147610854|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
73923929|NCT03642717|147376642|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in diastolic blood pressure (DBP) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
73923930|NCT00946712|147376645|OTHER||Hazard Ratio (HR)|0.93||||0.22|TWO_SIDED|95.0|0.83|1.04|||Log Rank|A stratified log rank test was used.||||1.04|0.83|0.22
73923931|NCT00946712|147376646|OTHER||Hazard Ratio (HR)|0.92||||0.4|TWO_SIDED|95.0|0.75|1.12|||Log Rank|A stratified log rank test was used.||||1.12|0.75|0.40
74028572|NCT00958568|147610855|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||<0.001
74028573|NCT00958568|147610856|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||0.831
74028574|NCT00958568|147610857|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||<0.001
74087055|NCT01652729|147728139|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.96|STANDARD_ERROR_OF_MEAN|15.71||0.0248|TWO_SIDED|95.0|-67.23|-4.68||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (\< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.||||-4.68|-67.23|0.0248
73923932|NCT00946712|147376647|OTHER||Hazard Ratio (HR)|0.81||||0.054|TWO_SIDED|95.0|0.66|1.0|||Log Rank|A stratified log rank test was used.||||1.00|0.66|0.054
73923933|NCT00946712|147376649|OTHER||Hazard Ratio (HR)|0.99||||0.83|TWO_SIDED|95.0|0.88|1.1|||Log Rank|A stratified log rank test was used.||||1.10|0.88|0.83
73923934|NCT00946712|147376651|OTHER|||||||0.48|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.||||||0.48
73923935|NCT00946712|147376652|OTHER|||||||0.06|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.||||||0.060
73923936|NCT04665050|147376654|OTHER|Estimated difference and confidence interval (CI) are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7|||||V116 minus PNEUMOVAX™23|Injection Site Erythema||12.7|-12.7|
73923937|NCT04665050|147376654|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|-11.8|||||TWO_SIDED|95.0|-30.0|7.3|||||V116 minus PNEUMOVAX™23|Injection Site Pain||7.3|-30.0|
73923938|NCT04665050|147376654|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||V116 minus PNEUMOVAX™23|Injection Site Swelling||14.1|-14.1|
73923939|NCT04665050|147376655|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|3.9|||||TWO_SIDED|95.0|-9.4|17.5|||||V116 minus PNEUMOVAX™23|Fatigue||17.5|-9.4|
73923940|NCT04665050|147376655|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-9.9|9.9|||||V116 minus PNEUMOVAX™23|Arthralgia||9.9|-9.9|
73923941|NCT04665050|147376655|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|-2.0|||||TWO_SIDED|95.0|-17.5|13.6|||||V116 minus PNEUMOVAX™23|Myalgia||13.6|-17.5|
73923942|NCT04665050|147376655|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7|||||V116 minus PNEUMOVAX™23|Headache||12.7|-12.7|
74028575|NCT00958568|147610861|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Remission rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||0.047
74087056|NCT01652729|147728139|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.89|STANDARD_ERROR_OF_MEAN|19.66||0.2914|TWO_SIDED|95.0|-60.02|18.25||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (\< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.||||18.25|-60.02|0.2914
73861912|NCT02698371|147269678|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.006||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.006
73861913|NCT02698371|147269678|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.020
73861914|NCT02698371|147269678|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.054||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.054
73861915|NCT02698371|147269679|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.01||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.010
73861916|NCT02698371|147269679|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.071||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.071
73861917|NCT02698371|147269679|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.898||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.898
73861918|NCT02698371|147269680|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.317
73861919|NCT02698371|147269680|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.18||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.180
73861920|NCT02698371|147269680|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.918||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.918
73923943|NCT04665050|147376656|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-7.1|7.1|||||V116 minus PNEUMOVAX™23|||7.1|-7.1|
73923944|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.07|2.4|||||V116/PNEUMOVAX™23|Serotype 3||2.40|1.07|
74028576|NCT00958568|147610862|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.91|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.46|-1.36||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-1.36|-4.46|<0.001
73923945|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.21|||||TWO_SIDED|95.0|0.69|2.11|||||V116/PNEUMOVAX™23|Serotype 7F||2.11|0.69|
73923946|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.0|||||TWO_SIDED|95.0|1.24|3.24|||||V116/PNEUMOVAX™23|Serotype 19A||3.24|1.24|
73923947|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.92|||||TWO_SIDED|95.0|1.04|3.57|||||V116/PNEUMOVAX™23|Serotype 22F||3.57|1.04|
73923948|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.71|1.86|||||V116/PNEUMOVAX™23|Serotype 33F||1.86|0.71|
73923949|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.78|||||TWO_SIDED|95.0|1.24|2.58|||||V116/PNEUMOVAX™23|Serotype 8||2.58|1.24|
74028577|NCT00958568|147610863|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.82|||<|0.001|TWO_SIDED|95.0|-5.39|-2.24||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.||||-2.24|-5.39|<0.001
73923950|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.89|||||TWO_SIDED|95.0|1.19|3.0|||||V116/PNEUMOVAX™23|Serotype 9N||3.00|1.19|
74028578|NCT00958568|147610864|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.002|TWO_SIDED|95.0|-0.55|-0.12||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-0.12|-0.55|0.002
73861921|NCT02698371|147269681|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||0.317
73861922|NCT02698371|147269681|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||.317
73861923|NCT02698371|147269681|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.575||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion \& Abfraction-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||0.575
73861924|NCT02698371|147269682|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.020
73861925|NCT02698371|147269682|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.107||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.107
73861926|NCT02698371|147269682|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.592||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.592
73923951|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.71|||||TWO_SIDED|95.0|1.47|5.0|||||V116/PNEUMOVAX™23|Serotype 10A||5.00|1.47|
73923952|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.43|||||TWO_SIDED|95.0|1.52|3.89|||||V116/PNEUMOVAX™23|Serotype 11A||3.89|1.52|
73923953|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.4|||||TWO_SIDED|95.0|1.2|4.83|||||V116/PNEUMOVAX™23|Serotype 12F||4.83|1.20|
73861927|NCT02698371|147269683|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
73861928|NCT02698371|147269683|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
73861929|NCT02698371|147269683|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
73923954|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.57|||||TWO_SIDED|95.0|1.59|4.17|||||V116/PNEUMOVAX™23|Serotype 17F||4.17|1.59|
73923955|NCT04665050|147376657|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.28|||||TWO_SIDED|95.0|1.46|3.56|||||V116/PNEUMOVAX™23|Serotype 20A||3.56|1.46|
73923956|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.54|||||TWO_SIDED|95.0|1.08|2.21|||||V116/PNEUMOVAX™23|Serotype 3||2.21|1.08|
73923957|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.21|||||TWO_SIDED|95.0|1.36|3.6|||||V116/PNEUMOVAX™23|Serotype 7F||3.60|1.36|
73923958|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.16|||||TWO_SIDED|95.0|1.45|3.23|||||V116/PNEUMOVAX™23|Serotype 19A||3.23|1.45|
74028579|NCT00958568|147610867|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.72||0.007|TWO_SIDED|95.0|-3.36|-0.53||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.||||-0.53|-3.36|0.007
74028580|NCT00958568|147610868|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
74087057|NCT01311557|147728150|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Pertussis toxoid (PT) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.843|1.05||||||||1.05|0.843|
74087058|NCT01311557|147728150|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% CI was constructed around each of the ratios: anti-Filamentous hemagglutinin (FHA) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.944|1.13||||||||1.13|0.944|
73861930|NCT02698371|147269684|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.011||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.011
73861931|NCT02698371|147269684|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.034||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.034
73861932|NCT02698371|147269684|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.885||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.885
73861933|NCT02698371|147269685|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||1.000
73861934|NCT02698371|147269685|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||0.317
73861935|NCT02698371|147269685|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.403||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||0.403
73923959|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.33|||||TWO_SIDED|95.0|1.36|3.99|||||V116/PNEUMOVAX™23|Serotype 22F||3.99|1.36|
73923960|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.52|||||TWO_SIDED|95.0|0.97|2.37|||||V116/PNEUMOVAX™23|Serotype 33F||2.37|0.97|
73923961|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.88|||||TWO_SIDED|95.0|1.32|2.68|||||V116/PNEUMOVAX™23|Serotype 8||2.68|1.32|
73923962|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.37|||||TWO_SIDED|95.0|1.49|3.74|||||V116/PNEUMOVAX™23|Serotype 9N||3.74|1.49|
73923963|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.16|||||TWO_SIDED|95.0|1.28|3.65|||||V116/PNEUMOVAX™23|Serotype 10A||3.65|1.28|
73923964|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.92|||||TWO_SIDED|95.0|1.28|2.89|||||V116/PNEUMOVAX™23|Serotype 11A||2.89|1.28|
73923965|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.49|||||TWO_SIDED|95.0|1.94|6.27|||||V116/PNEUMOVAX™23|Serotype 12F||6.27|1.94|
73923966|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.88|||||TWO_SIDED|95.0|1.92|4.31|||||V116/PNEUMOVAX™23|Serotype 17F||4.31|1.92|
73923967|NCT04665050|147376658|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.05|||||TWO_SIDED|95.0|1.3|3.25|||||V116/PNEUMOVAX™23|Serotype 20A||3.25|1.30|
73923968|NCT04665050|147376659|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|3.58|||||TWO_SIDED|95.0|1.86|6.88|||||V116/PNEUMOVAX™23|Serotype 6A||6.88|1.86|
73861936|NCT02698371|147269686|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.020
73861937|NCT02698371|147269686|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.020
73861938|NCT02698371|147269686|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.04||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.040
73861939|NCT02698371|147269687|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||<0.001
73861940|NCT02698371|147269687|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||<0.001
73861941|NCT02698371|147269687|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.211||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||0.211
73861942|NCT02698371|147269688|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.102||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.102
73861943|NCT02698371|147269688|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.18||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.180
73861944|NCT02698371|147269688|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.99||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.990
73861945|NCT02698371|147269689|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.157||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.157
73861946|NCT02698371|147269689|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.317
73861947|NCT02698371|147269689|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.334||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.334
73923969|NCT04665050|147376659|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|6.23|||||TWO_SIDED|95.0|3.54|10.98|||||V116/PNEUMOVAX™23|Serotype 15A||10.98|3.54|
73923970|NCT04665050|147376659|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|2.33|||||TWO_SIDED|95.0|1.23|4.39|||||V116/PNEUMOVAX™23|Serotype 15C||4.39|1.23|
73923971|NCT04665050|147376659|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|10.06|||||TWO_SIDED|95.0|5.39|18.78|||||V116/PNEUMOVAX™23|Serotype 16F||18.78|5.39|
73923972|NCT04665050|147376659|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|42.09|||||TWO_SIDED|95.0|19.67|90.03|||||V116/PNEUMOVAX™23|Serotype 23A||90.03|19.67|
73923973|NCT04665050|147376659|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|12.37|||||TWO_SIDED|95.0|6.97|21.94|||||V116/PNEUMOVAX™23|Serotype 23B||21.94|6.97|
73923974|NCT04665050|147376659|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|24.82|||||TWO_SIDED|95.0|11.65|52.86|||||V116/PNEUMOVAX™23|Serotype 24F||52.86|11.65|
73923975|NCT04665050|147376659|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|25.66|||||TWO_SIDED|95.0|14.65|44.93|||||V116/PNEUMOVAX™23|Serotype 31||44.93|14.65|
73923976|NCT04665050|147376659|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|14.3|||||TWO_SIDED|95.0|8.72|23.47|||||V116/PNEUMOVAX™23|Serotype 35B||23.47|8.72|
73968184|NCT04610892|147474410|SUPERIORITY||Least Squares mean difference|-1.29||||0.981||90.0|-2.32|-0.27||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.27|-2.32|0.981
73968185|NCT04610892|147474410|SUPERIORITY||Least Squares mean difference|-0.8||||0.974||90.0|-1.47|-0.12||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.12|-1.47|0.974
73968186|NCT04610892|147474410|SUPERIORITY||Least Squares mean difference|-0.86||||0.983||90.0|-1.53|-0.2||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.20|-1.53|0.983
73968187|NCT04610892|147474410|SUPERIORITY||Least Squares mean difference|-0.83||||0.99||90.0|-1.42|-0.25||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.25|-1.42|0.990
73968188|NCT04610892|147474411|SUPERIORITY||Least Squares mean difference|-2.14||||0.959||90.0|-4.16|-0.12||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.12|-4.16|0.959
73968189|NCT04610892|147474411|SUPERIORITY||Least Squares mean difference|-2.92||||0.998||90.0|-4.53|-1.31||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-1.31|-4.53|0.998
73968190|NCT04610892|147474411|SUPERIORITY||Least Squares mean difference|-1.35||||0.939||90.0|-2.79|0.09||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.09|-2.79|0.939
73968191|NCT04610892|147474411|SUPERIORITY||Least Squares mean difference|-1.94||||0.991||90.0|-3.27|-0.62||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.62|-3.27|0.991
73968192|NCT04610892|147474412|SUPERIORITY||Least Squares mean difference|-16.137||||0.077||90.0|-34.7829|2.5089||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.5089|-34.7829|0.077
74087059|NCT01311557|147728150|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% CI was constructed around each of the ratios: Anti-Pertactin (PRN) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.05|||||TWO_SIDED|95.0|0.928|1.18||||||||1.18|0.928|
73968193|NCT04610892|147474412|SUPERIORITY||Least Squares mean difference|-0.5927||||0.468||90.0|-12.7267|11.5413||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||11.5413|-12.7267|0.468
73968194|NCT04610892|147474412|SUPERIORITY||Least Squares mean difference|-0.1767||||0.491||90.0|-12.4678|12.1144||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||12.1144|-12.4678|0.491
73968195|NCT04610892|147474412|SUPERIORITY||Least Squares mean difference|-0.393||||0.476||90.0|-11.0022|10.2162||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||10.2162|-11.0022|0.476
73968196|NCT04610892|147474413|SUPERIORITY||Least Squares mean difference|-4.3435||||0.136||90.0|-10.8637|2.1768||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.1768|-10.8637|0.136
73923977|NCT04665050|147376660|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.0|||||TWO_SIDED|95.0|1.73|5.19|||||V116/PNEUMOVAX™23|Serotype 6A||5.19|1.73|
73923978|NCT04665050|147376660|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.03|||||TWO_SIDED|95.0|4.61|13.98|||||V116/PNEUMOVAX™23|Serotype 15A||13.98|4.61|
73923979|NCT04665050|147376660|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.14|||||TWO_SIDED|95.0|1.77|5.58|||||V116/PNEUMOVAX™23|Serotype 15C||5.58|1.77|
73923980|NCT04665050|147376660|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|13.06|||||TWO_SIDED|95.0|8.45|20.19|||||V116/PNEUMOVAX™23|Serotype 16F||20.19|8.45|
73923981|NCT04665050|147376660|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.55|||||TWO_SIDED|95.0|5.19|14.09|||||V116/PNEUMOVAX™23|Serotype 23A||14.09|5.19|
73923982|NCT04665050|147376660|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|4.15|||||TWO_SIDED|95.0|2.72|6.36|||||V116/PNEUMOVAX™23|Serotype 23B||6.36|2.72|
73923983|NCT04665050|147376660|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|28.68|||||TWO_SIDED|95.0|16.59|49.58|||||V116/PNEUMOVAX™23|Serotype 24F||49.58|16.59|
73923984|NCT04665050|147376660|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|10.27|||||TWO_SIDED|95.0|6.71|15.73|||||V116/PNEUMOVAX™23|Serotype 31||15.73|6.71|
73923985|NCT04665050|147376660|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|15.95|||||TWO_SIDED|95.0|11.62|21.9|||||V116/PNEUMOVAX™23|Serotype 35B||21.90|11.62|
73923986|NCT03245008|147376682|SUPERIORITY||Least Squares Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.57|-0.86||Adjusted P-value|Mixed Models Analysis|||||-0.86|-1.57|<0.001
73923987|NCT03245008|147376682|SUPERIORITY||Least Squares Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.21||0.103|TWO_SIDED|95.0|-0.76|0.07||Adjusted P-value|Mixed Models Analysis|||||0.07|-0.76|0.103
73923988|NCT03245008|147376683|SUPERIORITY||Least Squares Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.6|-0.92||Adjusted P-value|Mixed Models Analysis|||||-0.92|-1.60|<0.001
73923989|NCT03245008|147376683|SUPERIORITY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.84|-0.05||||||||-0.05|-0.84|
73923990|NCT01876485|147376702|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 4. The value of HbA1c at 4 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."||||0.003
73923991|NCT01876485|147376702|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.6|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 10 months. The value of HbA1c at 10 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."||||.60
73923992|NCT01876485|147376703|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 4 months. The value of DDS at 4 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.||||0.003
73968197|NCT04610892|147474413|SUPERIORITY||Least Squares mean difference|-1.2369||||0.316||90.0|-5.4796|3.0059||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||3.0059|-5.4796|0.316
73968198|NCT04610892|147474413|SUPERIORITY||Least Squares mean difference|-0.7015||||0.394||90.0|-5.0096|3.6065||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||3.6065|-5.0096|0.394
73968199|NCT04610892|147474413|SUPERIORITY||Least Squares mean difference|-0.9799||||0.332||90.0|-4.6927|2.7329||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.7329|-4.6927|0.332
73968200|NCT05520190|147474423|SUPERIORITY||Standardized Response Mean|-0.47|||||TWO_SIDED||||||||Baseline Attitude score - 1-month Attitude score / SD of average change|||||
73968201|NCT05520190|147474424|SUPERIORITY||Standardized Response Mean|-0.23|||||TWO_SIDED||||||||Baseline Norm score - 1-month Norm score / SD of average change|||||
73968202|NCT05520190|147474425|SUPERIORITY||Standardized Response Mean|-0.03|||||TWO_SIDED||||||||Baseline Perceived Behavioral Control score - 1-month Perceived Behavioral Control score / SD of average change|||||
74028581|NCT00958568|147610869|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.248
73968203|NCT05520190|147474426|SUPERIORITY||Standardized Response Mean|-0.16|||||TWO_SIDED||||||||Baseline Intention score - 1-month Intention score / SD of average change|||||
73968204|NCT05520190|147474427|SUPERIORITY||Standardized Response Mean|0.35|||||TWO_SIDED||||||||Baseline drinks per day - 1-month drinks per day / avg change in drinks per day|||||
73968205|NCT05520190|147474428|SUPERIORITY||Standardized Response Mean|0.35|||||TWO_SIDED||||||||Baseline drinking days - 1-month drinking days / SD of avg change in drinking days|||||
73923993|NCT01876485|147376703|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 10 months. The value of DDS at 10 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.||||.003
73968206|NCT05520190|147474429|SUPERIORITY||Standardized Response Mean|0.3|||||TWO_SIDED||||||||Baseline binge drinking days - 1-month binge drinking days / avg change in binge drinking days|||||
74028582|NCT00958568|147610870|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
73923994|NCT05760300|147376711|OTHER||Geometric Least-squares Mean Ratio|84.5|||||TWO_SIDED|90.0|60.1|119.0|||||Parametric (normal theory) analysis of covariance (ANOVA) model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||119|60.1|
73968207|NCT05520190|147474430|SUPERIORITY||Standardized Response Mean|1.23|||||TWO_SIDED||||||||Baseline depression - 1-month depression / SD of avg change in depression|||||
73968208|NCT05520190|147474431|SUPERIORITY||Standardized Response Mean|1.06|||||TWO_SIDED||||||||Baseline anxiety - 1-month anxiety / SD avg change in anxiety|||||
73968209|NCT05520190|147474432|SUPERIORITY||Standardized Response Mean|0.9|||||TWO_SIDED||||||||Baseline PTSD - 1-month PTSd / SD avg change in PTSD|||||
73968210|NCT05520190|147474433|SUPERIORITY||Standardized Response Mean|0.6|||||TWO_SIDED||||||||Baseline insomnia - 1-month insomnia / SD avg change in insomnia|||||
73968211|NCT05520190|147474434|SUPERIORITY||Standardized Response Mean|0.58|||||TWO_SIDED||||||||Baseline Alcohol Screen - 1-month Alcohol Screen / SD avg change|||||
73968212|NCT05520190|147474435|SUPERIORITY||Standardized Response Mean|-0.39|||||TWO_SIDED||||||||Baseline behavioral beliefs - 1-month behavioral beliefs / avg change in behavioral beliefs|||||
74028583|NCT00958568|147610871|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|4.47||0.839|TWO_SIDED|95.0|-9.71|7.89||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||7.89|-9.71|0.839
74028584|NCT00958568|147610872|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.352
73861948|NCT02698371|147269690|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.132||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.132
73861949|NCT02698371|147269690|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.257||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.257
73861950|NCT02698371|147269690|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.918||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.918
73861951|NCT01999218|147269707|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares Means|0.1|||||TWO_SIDED|95.0|-0.02|0.22|||||Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.|||0.22|-0.02|
73861952|NCT01999218|147269707|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares means|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||"Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.~Time was treated as a categorical variable."|||0.30|0.06|
73861953|NCT01999218|147269708|OTHER|Based on Miettinen \& Nurminen method|Difference in % vs. Glimepiride|1.6|||||TWO_SIDED|95.0|-4.5|7.7||||||||7.7|-4.5|
73861954|NCT01999218|147269708|OTHER|Based on Miettinen \& Nurminen method|Difference in % vs. Glimepiride|0.5|||||TWO_SIDED|95.0|-5.6|6.5||||||||6.5|-5.6|
73861955|NCT01999218|147269709|OTHER||Difference in % vs. Glimepiride|3.0|||||TWO_SIDED|95.0|-0.3|6.4||||||||6.4|-0.3|
73861956|NCT01999218|147269709|OTHER||Difference in % vs. Glimepiride|1.5|||||TWO_SIDED|95.0|-1.7|4.7||||||||4.7|-1.7|
73861957|NCT01999218|147269710|OTHER||Difference in % vs. Glimepiride|-14.0|||<|0.001|TWO_SIDED|95.0|-18.4|-9.8|||Based on Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method|-9.8|-18.4|<0.001
73861958|NCT01999218|147269710|OTHER||Difference in % vs. Glimepiride|-16.1|||<|0.001|TWO_SIDED|95.0|-20.3|-12.2|||Based on Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method|-12.2|-20.3|<0.001
73861959|NCT01999218|147269711|OTHER||Difference in LSM vs. Glimepiride|-4.29|||<|0.001|TWO_SIDED|95.0|-4.77|-3.8|||Constrained Longitudinal Data analysis||LSM=Least Squares Means||Constrained Longitudinal Data analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.80|-4.77|<0.001
73861960|NCT01999218|147269711|OTHER||Difference in the LSM vs. Glimepiride|-3.87|||<|0.001|TWO_SIDED|95.0|-4.36|-3.38|||Constrained Longitudinal Data Analysis||||Constrained Longitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.38|-4.36|<0.001
73861961|NCT01999218|147269712|OTHER||Difference in the LSM vs. Glimepiride|-4.77|||<|0.001|TWO_SIDED|95.0|-6.29|-3.25|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.25|-6.29|<0.001
73861962|NCT01999218|147269712|OTHER||Difference in the LSM vs. Glimepiride|-3.2|||<|0.001|TWO_SIDED|0.001|-4.73|-1.67|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-1.67|-4.73|<0.001
73861963|NCT00734071|147269786|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.911||0.518|TWO_SIDED|95.0|-1.2|2.38||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||2.38|-1.20|0.518
73923995|NCT05760300|147376711|OTHER||Geometric Least-squares Mean Ratio|104.0|||||TWO_SIDED|90.0|80.8|133.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||133|80.8|
73923996|NCT05760300|147376712|OTHER||Geometric Least-squares Mean Ratio|106.0|||||TWO_SIDED|90.0|63.6|175.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||175|63.6|
73923997|NCT05760300|147376712|OTHER||Geometric Least-squares Mean Ratio|108.0|||||TWO_SIDED|90.0|77.8|151.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||151|77.8|
73923998|NCT05760300|147376713|OTHER||Geometric Least-squares Mean Ratio|83.8|||||TWO_SIDED|90.0|67.4|104.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||104|67.4|
73861964|NCT00734071|147269787|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.542||0.685|TWO_SIDED|95.0|-1.29|0.85||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05).||0.85|-1.29|0.685
73861965|NCT00734071|147269788|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.984|TWO_SIDED|95.0|-0.27|0.28||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||0.28|-0.27|0.984
73861966|NCT00734071|147269789|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.866||0.703|TWO_SIDED|95.0|-1.38|2.04||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||2.04|-1.38|0.703
73923999|NCT05760300|147376713|OTHER||Geometric Least-squares Mean Ratio|100.0|||||TWO_SIDED|90.0|56.2|179.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||179|56.2|
73968213|NCT05520190|147474436|SUPERIORITY||Standardized Response Mean|-0.62|||||TWO_SIDED||||||||Baseline normative beliefs - 1-month normative beliefs / SD avg change in normative beliefs|||||
73968214|NCT05520190|147474437|SUPERIORITY||Standardized Response Mean|-0.83|||||TWO_SIDED||||||||Baseline control beliefs - 1-month control beliefs / SD avg change in control beliefs|||||
73968215|NCT01999075|147474438|SUPERIORITY||Mean Difference (Net)|1.9||||0.68|TWO_SIDED|95.0|-6.9|10.7||The a priori threshold for statistical significance was a two-sided p-value of 0.05.|ANCOVA||"The mean difference between the intervention and the control group in the change from baseline to 2 years was estimated.~Estimates presented here are based on multiple imputation of missing values."|||10.7|-6.9|0.68
73968216|NCT01999075|147474442|SUPERIORITY||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-1.92|2.18||||||Difference in change in peak cough flow (L/min) from baseline to 2 years, between conventional treatment and intervention group.||2.18|-1.92|
73968217|NCT01999075|147474443|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
74028585|NCT00958568|147610872|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
73861967|NCT00734071|147269790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||0.602|TWO_SIDED|95.0|0.713|1.795|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.795|0.713|0.602
73861968|NCT00734071|147269791|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|1.558||0.995|TWO_SIDED|95.0|-3.09|3.07||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||3.07|-3.09|0.995
73968218|NCT01999075|147474444|SUPERIORITY|||||||1|||||||Mixed Models Analysis|||||||1.00
73968219|NCT01999075|147474445|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
73968220|NCT03683719|147474448|SUPERIORITY||||||<|0.001||||||"P-values were adjusted for multiple comparisons. Models with an adjusted p-value \<0.025 were statistically sign. different from a flat dose-response model. Model: IGA-CHE TS = Treatment + Region + Baseline IGA-CHE.~Model selected: Emax model"|Multiple contrast test|||The primary endpoint was evaluated by determining if there was a dose-response relationship between the IGA-CHE response rate at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve.||||<0.001
73968221|NCT03683719|147474448|SUPERIORITY||Risk Difference (RD)|13.29|||>|0.05|TWO_SIDED|95.0|0.34|26.24||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||26.24|0.34|>0.05
74087060|NCT01311557|147728150|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was constructed around each of the ratios: anti-Fimbriae types 2 and 3 (FIM) GMT Group 1 / GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.|GMT Ratio|0.882|||||TWO_SIDED|95.0|0.731|1.06||||||||1.06|0.731|
73924000|NCT05760300|147376714|OTHER||Geometric Least-squares Mean Ratio|96.5|||||TWO_SIDED|90.0|65.1|143.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||143|65.1|
74028586|NCT00958568|147610872|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
74028587|NCT00958568|147610873|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|4.12||0.703|TWO_SIDED|95.0|-9.69|6.54||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||6.54|-9.69|0.703
74028588|NCT00958568|147610874|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.139
73861969|NCT00734071|147269792|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|2.951||0.731|TWO_SIDED|95.0|-4.79|6.83||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||6.83|-4.79|0.731
73861970|NCT03323736|147269843|SUPERIORITY|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.80) exceeded the 68% success rate performance goal.|Credible Interval|0.86|||||TWO_SIDED|95.0|0.8|0.91||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.||0.91|0.80|
73861971|NCT03323736|147269843|SUPERIORITY|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.82) exceeded the 68% success rate performance goal.|Credible Interval|0.89|||||TWO_SIDED|95.0|0.82|0.93||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.||0.93|0.82|
73924001|NCT05760300|147376714|OTHER||Geometric Least-squares Mean Ratio|77.8|||||TWO_SIDED|90.0|42.7|142.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||142|42.7|
73924002|NCT05760300|147376719|OTHER||Geometric Least-squares Mean Ratio|160.0|||||TWO_SIDED|90.0|97.2|263.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||263|97.2|
73924003|NCT05760300|147376719|OTHER||Geometric Least-squares Mean Ratio|65.9|||||TWO_SIDED|90.0|35.0|124.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||124|35.0|
73924004|NCT05760300|147376719|OTHER||Geometric Least-squares Mean Ratio|86.7|||||TWO_SIDED|90.0|53.3|141.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||141|53.3|
74028589|NCT00958568|147610874|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.746
74028590|NCT00958568|147610874|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.458
73861972|NCT03323736|147269844|SUPERIORITY|Comparison of mean tube placement FPS-R score to a performance goal of 4.2.||||||0.0072||||||Mean FPS-R score hypothesized to be less than (superior to) a performance goal of 4.2, at a significance level of 0.025 (p\<0.025).|t-test, 1 sided|||||||0.0072
73861973|NCT03323736|147269845|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>80%, at alpha = 0.025.|mid-P method for single proportion|||Tube Patency endpoint would be successfully met if the percentage of subjects with patent tubes was greater than (superior to) 80% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
73861974|NCT03323736|147269846|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>88%, at alpha = 0.025.|mid-P method for single proportion|||Tube Retention endpoint would be successfully met if the percentage of subjects with retained tubes was greater than (superior to) 88% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
73924005|NCT05760300|147376719|OTHER||Geometric Least-squares Mean Ratio|72.6|||||TWO_SIDED|90.0|50.4|105.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||105|50.4|
73924006|NCT05760300|147376720|OTHER||Geometric Least-squares Mean Ratio|139.0|||||TWO_SIDED|90.0|87.8|221.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||221|87.8|
73924007|NCT05760300|147376720|OTHER||Geometric Least-squares Mean Ratio|66.8|||||TWO_SIDED|90.0|37.3|120.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||120|37.3|
73924008|NCT05760300|147376720|OTHER||Geometric Least-squares Mean Ratio|85.7|||||TWO_SIDED|90.0|54.5|135.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||135|54.5|
73924009|NCT05760300|147376720|OTHER||Geometric Least-squares Mean Ratio|70.3|||||TWO_SIDED|90.0|49.4|100.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||100|49.4|
73924010|NCT05760300|147376721|OTHER||Geometric Least-squares Mean Ratio|84.2|||||TWO_SIDED|90.0|32.7|217.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||217|32.7|
73924011|NCT05760300|147376721|OTHER||Geometric Least-squares Mean Ratio|58.0|||||TWO_SIDED|90.0|30.1|112.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||112|30.1|
73924012|NCT05760300|147376721|OTHER||Geometric Least-squares Mean Ratio|85.6|||||TWO_SIDED|90.0|54.1|135.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||135|54.1|
74028591|NCT00958568|147610875|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.73|STANDARD_ERROR_OF_MEAN|1.15||0.001|TWO_SIDED|95.0|-5.99|-1.47||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-1.47|-5.99|0.001
73861975|NCT03323736|147269847|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>85%, at alpha = 0.025.|mid-P method for single proportion|||The Anesthesia Effectiveness endpoint would be successfully met if the percentage of subjects with successful anesthesia was greater than (superior to) 85% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
73924013|NCT05760300|147376721|OTHER||Geometric Least-squares Mean Ratio|69.6|||||TWO_SIDED|90.0|48.9|99.2|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||99.2|48.9|
73924014|NCT03628703|147376728|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
73924015|NCT02117999|147376734|NON_INFERIORITY|Sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D.|||||<|0.05|||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values. The relationship between the change in Kmax at 12 months and baseline parameters was assessed using Pearson's correlation analysis for either group.||||<0.05
73924016|NCT02117999|147376735|NON_INFERIORITY|sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D. The sample size of the study was 34 cases (allocation ratio of 2:1)|Mean Difference (Final Values)|35.0||||0.05|TWO_SIDED||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values.||||0.05
73924017|NCT01252940|147376755|NON_INFERIORITY_OR_EQUIVALENCE|A 95% confidence interval (CI) for the difference between treatment groups in the percentages of virologic success was constructed using normal approximation. Noninferiority was assessed using a conventional 95% CI approach, with a noninferiority margin of 12%. It would be concluded that the FTC/RPV/TDF STR group was not inferior to the SBR group if the lower bound of the 2-sided 95% CI of the difference (FTC/RPV/TDF STR - SBR) in the response rate was greater than -12%.|Mean Difference (Net)|3.8|||||TWO_SIDED|95.0|-1.6|9.1||||||||9.1|-1.6|
73924018|NCT02496533|147376781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8|||<|0.001|TWO_SIDED|||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported anxiety as self-reported change of VAS between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.001
73924019|NCT02496533|147376782|SUPERIORITY_OR_OTHER||||||<|0.02||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported systolic blood pressure measurements between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.02
73968222|NCT03683719|147474448|SUPERIORITY||Risk Difference (RD)|-0.03|||>|0.05|TWO_SIDED|95.0|-10.44|10.39||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||10.39|-10.44|>0.05
74028592|NCT00958568|147610876|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.004
74028593|NCT00958568|147610877|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
73924020|NCT02496533|147376782|SUPERIORITY_OR_OTHER||||||<|0.09||||||No multiple comparisons were conducted in this analysis. P-Value not adjusted for multiple comparisons. No interim analyses were performed.|ANOVA|||H0: No difference in reported diastolic blood pressure between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.09
73924021|NCT02496533|147376783|SUPERIORITY_OR_OTHER||||||<|0.009||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported respiration rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.009
73924022|NCT02496533|147376784|SUPERIORITY_OR_OTHER||||||<|0.45||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported pulse rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.45
73924023|NCT01280552|147376798|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Stratified for age and MGMT methylation status|Log Rank|||Stratified log rank p value stratified for age and MGMT methylation status||||0.010
73924024|NCT01280552|147376800|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Analyses were stratified for age and MGMT methylation status.|Log Rank|||||||0.033
73924025|NCT02016625|147376801|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis (H0): ratio is outside of interval (80%, 125%) vs. alternative hypothesis (H1): ratio is inside of interval (80%, 125%)|gMean ratio (%)|108.2|STANDARD_ERROR_OF_MEAN|11.5||0.0033|TWO_SIDED|90.0|99.992|117.076|||ANOVA||ratio of cyclo + FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|Geometric mean (gMean) ratio of cyclo + FDV to cyclo treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||117.076|99.992|0.0033
73861976|NCT02262078|147269879|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
73924026|NCT02016625|147376802|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) vs. H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|106.6|STANDARD_ERROR_OF_MEAN|11.7||0.0019|TWO_SIDED|90.0|98.36|115.534|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||115.534|98.360|0.0019
73924027|NCT02016625|147376803|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|90.14|STANDARD_ERROR_OF_MEAN|16.6||0.0457|TWO_SIDED|90.0|80.281|101.205|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||101.205|80.281|0.0457
73924028|NCT02016625|147376804|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|140.98|STANDARD_ERROR_OF_MEAN|35.8||0.8122|TWO_SIDED|90.0|111.772|177.833|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||177.833|111.772|0.8122
73924029|NCT02016625|147376805|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|116.92|STANDARD_ERROR_OF_MEAN|11.0||0.065|TWO_SIDED|90.0|108.674|125.801|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||125.801|108.674|0.0650
73924030|NCT02016625|147376806|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|122.68|STANDARD_ERROR_OF_MEAN|23.9||0.4181|TWO_SIDED|90.0|104.8|143.6|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||143.60|104.80|0.4181
73924031|NCT02016625|147376807|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|127.41|STANDARD_ERROR_OF_MEAN|16.8||0.6207|TWO_SIDED|90.0|114.453|141.827|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||141.827|114.453|0.6207
73924032|NCT02016625|147376808|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|136.85|STANDARD_ERROR_OF_MEAN|22.4||0.8592|TWO_SIDED|90.0|118.683|157.793|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||157.793|118.683|0.8592
73968223|NCT03683719|147474448|SUPERIORITY||Risk Difference (RD)|28.22|||<|0.001|TWO_SIDED|95.0|13.8|42.64||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||42.64|13.8|<0.001
73861977|NCT01688739|147269882|OTHER||Ratio of Geometric Means|1.1||||0.7595|TWO_SIDED|90.0|0.8|1.4|||ANCOVA||Migraine participants / Healthy Participants|||1.4|0.8|0.7595
73861978|NCT01688739|147269884|OTHER||Ratio of Geometric Means|1.1||||0.5481|TWO_SIDED|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants|||1.4|0.9|0.5481
73971406|NCT04508309|147483472|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.25|||||TWO_SIDED|98.3|1.022|1.539|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||1.539|1.022|
73861979|NCT01688739|147269885|OTHER||Ratio of Geometric Means|1.1||||0.5506|TWO_SIDED|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants|||1.4|0.9|0.5506
73924033|NCT02016625|147376809|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.15|STANDARD_ERROR_OF_MEAN|28.5||0.0269|TWO_SIDED|90.0|82.857|118.644|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||118.644|82.857|0.0269
73924034|NCT02016625|147376810|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|93.85|STANDARD_ERROR_OF_MEAN|25.1||0.0493|TWO_SIDED|90.0|80.059|110.022|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||110.022|80.059|0.0493
73924035|NCT02016625|147376811|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.54|STANDARD_ERROR_OF_MEAN|10.0||0|TWO_SIDED|90.0|93.375|106.115|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||106.115|93.375|0.0000
73924036|NCT02016625|147376812|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|96.16|STANDARD_ERROR_OF_MEAN|12.9||0.0008|TWO_SIDED|90.0|88.53|104.45|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||104.45|88.53|0.0008
73968224|NCT03683719|147474448|SUPERIORITY||Risk Difference (RD)|29.61|||<|0.001|TWO_SIDED|95.0|14.56|44.67||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||44.67|14.56|<0.001
73968225|NCT03683719|147474449|SUPERIORITY||||||<|0.0001||||||"P-values were adjusted for multiple comparisons. Models with an adj. p-value \<0.025 were statistically sign. different from a flat dose-response model. Model: Change = Treatment + Baseline + Region + Baseline IGA-CHE.~Model selected: Emax model"|Multiple contrast test|||"The secondary endpoint Change from baseline to Week 16 in HECSI score was evaluated by determining if there was a dose-response relationship between the change from baseline in HECSI score at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve."||||<0.0001
73968226|NCT03683719|147474449|SUPERIORITY||Mean Difference (Net)|-13.41|||<|0.01|TWO_SIDED|95.0|-22.82|-4.01||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-4.01|-22.82|<0.01
73968227|NCT03683719|147474449|SUPERIORITY||Mean Difference (Net)|-9.53|||<|0.05|TWO_SIDED|95.0|-19.04|-0.02||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-0.02|-19.04|<0.05
74087061|NCT03478865|147728156|SUPERIORITY||Mean Difference (Final Values)|-2.54||||0.259|TWO_SIDED|95.0|-7.91|2.83||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 2 for Cohort 1)."||2.83|-7.91|0.259
74087062|NCT03478865|147728156|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.818|TWO_SIDED|95.0|-4.66|4.12||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 1 for Cohort 2)."||4.12|-4.66|0.818
73861980|NCT04172467|147269888|OTHER|To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.|Hazard Ratio (HR)|4.49|||<|0.001|TWO_SIDED|95.0|3.72|5.42||For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).|Regression, Cox|The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.||For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.||5.42|3.72|<0.001
73861981|NCT04172467|147269888|OTHER|To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.|Hazard Ratio (HR)|2.52|||<|0.001|TWO_SIDED|95.0|1.98|3.21||For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).|Regression, Cox|The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.||For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.||3.21|1.98|<0.001
73861982|NCT03369431|147269894|SUPERIORITY|||||||0.784|||||||t-test, 2 sided|||"Null hypothesis is that there is no difference in the percentage change from baseline in the ATEC Total between Vivomixx and Placebo.~A sample size of 72 participants was needed to determine an effect size of 0.50 with 80% power, with a type 1 error of 5% using a two-sided test. This calculation is based on the assumed effect size of the primary outcome measure, the ATEC. The minimally clinically important difference based on the primary outcome measure with this instrument was 15 points."||||0.784
73861983|NCT03369431|147269895|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Abdominal Pain between Vivomixx and Placebo.||||0.357
73861984|NCT03369431|147269895|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Gaseousness between Vivomixx and Placebo.||||0.290
73861985|NCT03369431|147269895|SUPERIORITY|||||||0.418|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Diarrhoea between Vivomixx and Placebo.||||0.418
73861986|NCT03369431|147269895|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Constipation between Vivomixx and Placebo.||||0.734
73861987|NCT03369431|147269895|SUPERIORITY|||||||0.362|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Pain on Stooling between Vivomixx and Placebo.||||0.362
73861988|NCT03369431|147269895|SUPERIORITY|||||||0.705|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Difficulty Swallowing between Vivomixx and Placebo.||||0.705
73861989|NCT03369431|147269895|SUPERIORITY|||||||0.589|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in change from baseline in frequency of vomiting between Vivomixx and placebo||||0.589
73924037|NCT02155738|147376813|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Aim 1: Quantify the impact of IV acetaminophen on 1a) postoperative pain scores ... 1a) To achieve this aim, we will measure the degree of postoperative pain using visual analog scales (VAS) at multiple specified time points throughout the postoperative period; we report on change from Baseline VAS at 24 Hours Postop. Null Hypothesis is that there is no difference between subgroups in VAS scores. Sample size was determined considering significant differences in VAS scores.||||<0.05
73861990|NCT03369431|147269895|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon signed rank||Null hypothesis is that there is no difference in change from baseline in frequency of blood in stool between Vivomixx and placebo||||1.0
73861991|NCT03369431|147269895|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon signed rank||Null hypothesis is that there is no difference in change from baseline in frequency of blood in vomit between Vivomixx and placebo||||1.0
73861992|NCT03369431|147269896|SUPERIORITY|||||||0.635|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline of ABC Irritability score between Vivomixx and Placebo||||0.635
73861993|NCT03369431|147269896|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||The null hypothesis is that there is no difference in the change from baseline of ABC Lethargy/social withdrawal score between Vivomixx and Placebo.||||0.367
73861994|NCT03369431|147269896|SUPERIORITY|||||||0.609|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in the ABC Stereotypic behaviour between Vivomixx and Placebo.||||0.609
73861995|NCT03369431|147269896|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|Paired samples t-test||Null hypothesis is that there is no difference in the change from baseline of the ABC Hyperactivity/Noncompliance between Vivomixx and Placebo.||||0.805
73861996|NCT03369431|147269896|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank test used.||Null hypothesis is that there is no difference in the change from baseline of the ABC Inappropriate Speech between Vivomixx and Placebo.||||0.985
73861997|NCT03369431|147269897|SUPERIORITY|||||||0.661|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||||||0.661
73924038|NCT02155738|147376814|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||1b) We will use equianalgesic dosage tables to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. We hypothesize that those patients receiving preemptive IV acetaminophen will have lower postoperative VAS scores and reduced narcotic requirements compared to placebo.||||<0.05
74087063|NCT03478865|147728157|SUPERIORITY||Mean Difference (Final Values)|-3.56||||0.365|TWO_SIDED|95.0|-13.24|6.12||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the post-treatment follow-up visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 3 for Cohort 1)."||6.12|-13.24|0.365
73861998|NCT06504524|147269907|OTHER||Hazard Ratio (HR)|1.128|||=|0.615|TWO_SIDED|95.0|0.705|1.804|||Regression, Cox||IPTW hazard ratio (HR) were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.804|0.705|=0.615
73861999|NCT06504524|147269908|OTHER||Hazard Ratio (HR)|1.18|||=|0.4429|TWO_SIDED|95.0|0.85|1.64|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.64|0.85|=0.4429
73862000|NCT06504524|147269909|OTHER||Hazard Ratio (HR)|0.66|||=|0.12|TWO_SIDED|95.0|0.39|1.115|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.115|0.390|=0.120
73862001|NCT06504524|147269910|OTHER||Hazard Ratio (HR)|0.52|||=|0.0011|TWO_SIDED|95.0|0.38|0.71|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.71|0.38|=0.0011
73862002|NCT06504524|147269911|OTHER||Hazard Ratio (HR)|0.759|||=|0.503|TWO_SIDED|95.0|0.337|1.71|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.710|0.337|=0.503
73862003|NCT06504524|147269912|OTHER||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.26|0.57|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.57|0.26|<0.0001
73862004|NCT06504524|147269913|OTHER||Hazard Ratio (HR)|0.918|||=|0.706|TWO_SIDED|95.0|0.587|1.436|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.436|0.587|=0.706
73862005|NCT06504524|147269914|OTHER||Hazard Ratio (HR)|0.68|||=|0.0182|TWO_SIDED|95.0|0.52|0.88|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.88|0.52|=0.0182
73924039|NCT01190254|147376816|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-4.8||||0.07|TWO_SIDED|95.0|-9.9|0.4||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.4|-9.9|0.070
73924040|NCT01190254|147376816|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.6||||0.064|TWO_SIDED|95.0|-10.7|-0.5||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.5|-10.7|0.064
73924041|NCT01190254|147376816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||||||p-value (adjusted to control Type I error in multiple testing) for Linear dose-response pattern (Placebo\<2.5 mg\<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.064
73924042|NCT01190254|147376816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||||||p-value (adjusted to control Type I error in multiple testing) for Convex dose-response pattern (Placebo\<2.5 mg=5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.046
73924043|NCT01190254|147376816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||||||p-value (adjusted to control Type I error in multiple testing) for Concave dose-response pattern (Placebo=2.5 mg\<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.273
74028594|NCT00958568|147610878|SUPERIORITY_OR_OTHER||LS Mean Difference|13.27|STANDARD_ERROR_OF_MEAN|7.62||0.083|TWO_SIDED|95.0|-1.72|28.26||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||28.26|-1.72|0.083
74028595|NCT00958568|147610879|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.029
73862006|NCT00733135|147269917|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||GEE|||||||<0.05
73862007|NCT00824005|147269923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.9||0.169|TWO_SIDED|95.0|-0.42|2.34||No adjustment for multiple comparisons|t-test, 2 sided|||Compare the change in the cell group to the change in the placebo group.||2.34|-0.42|0.169
73862008|NCT00824005|147269924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|23.9||0.856|TWO_SIDED|95.0|-10.05|12.07|||t-test, 2 sided|||Change in the difference of end systolic volume over time.||12.07|-10.05|0.856
73862009|NCT00824005|147269925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|22.3||0.835|TWO_SIDED|95.0|-12.5|10.1||Is the change in percent reversible defect the same between the two groups|t-test, 2 sided|||Change in percent of the defect that is reversible||10.1|-12.5|0.835
73924044|NCT01190254|147376817|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.2||||0.218|TWO_SIDED|95.0|-0.5|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-0.5|0.218
73924045|NCT01190254|147376817|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.3||||0.024||95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.0|-0.6|0.024
73924046|NCT01190254|147376818|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.6||||0.067|TWO_SIDED|95.0|-3.3|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-3.3|0.067
73924047|NCT01190254|147376818|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.1||||0.012|TWO_SIDED|95.0|-3.8|-0.5|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.5|-3.8|0.012
73924048|NCT01190254|147376819|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.097|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.097
73924049|NCT01190254|147376819|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.099|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.099
73924050|NCT01190254|147376820|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.7||||0.062|TWO_SIDED|95.0|-5.6|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-5.6|0.062
74087064|NCT03478865|147728157|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.48|TWO_SIDED|95.0|-12.94|19.41||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the post-treatment follow-up visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 2 for Cohort 2)."||19.41|-12.94|0.480
74087065|NCT02418455|147728170|SUPERIORITY||LS Mean|-61.0|STANDARD_ERROR_OF_MEAN|6.409|<|0.0001|TWO_SIDED|95.0|-73.56|-48.44||P-values are from generalized estimating equation (GEE) model including baseline value and visit as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||||-48.44|-73.56|< 0.0001
73924051|NCT01190254|147376820|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-3.2||||0.025|TWO_SIDED|95.0|-6.0|-0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.4|-6.0|0.025
73924052|NCT01190254|147376821|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.1||||0.098|TWO_SIDED|95.0|-4.6|0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.4|-4.6|0.098
73924053|NCT01190254|147376821|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.3||||0.071|TWO_SIDED|95.0|-4.8|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-4.8|0.071
73924054|NCT01190254|147376822|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.4||||0.106|TWO_SIDED|95.0|-3.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-3.1|0.106
73924055|NCT01190254|147376822|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.9||||0.026|TWO_SIDED|95.0|-3.6|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.2|-3.6|0.026
73924056|NCT01190254|147376823|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.083|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.083
74087066|NCT02418455|147728178|SUPERIORITY|||||||0.2655|||||||t-test|||||||0.2655
74087067|NCT02418455|147728179|SUPERIORITY||LS Mean|-0.99|STANDARD_ERROR_OF_MEAN|0.396||0.0122|TWO_SIDED|95.0|-1.77|-0.22||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12||-0.22|-1.77|0.0122
74087068|NCT02418455|147728179|SUPERIORITY||LS Mean|-1.21|STANDARD_ERROR_OF_MEAN|0.461||0.0086|TWO_SIDED|95.0|-2.12|-0.31||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24||-0.31|-2.12|0.0086
73924057|NCT01190254|147376823|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.3||||0.067|TWO_SIDED|95.0|-2.7|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-2.7|0.067
73924058|NCT01190254|147376824|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.131|TWO_SIDED|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-2.1|0.131
74087069|NCT02418455|147728179|SUPERIORITY||LS Mean|-0.98|STANDARD_ERROR_OF_MEAN|0.31||0.0016|TWO_SIDED|95.0|-1.58|-0.37||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 48||-0.37|-1.58|0.0016
73862010|NCT00824005|147269928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.471|TWO_SIDED|95.0|-0.3|0.14|||t-test, 2 sided|||Difference in the change between the two groups||0.14|-0.30|0.471
73862011|NCT00824005|147269929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25|STANDARD_DEVIATION|0.784||0.227|TWO_SIDED|95.0|-0.66|0.16|||t-test, 2 sided|||Change in average improvement in Canadian Class Score over time between the two groups.||0.16|-0.66|0.227
73924059|NCT01190254|147376824|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.135|TWO_SIDED|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-2.1|0.135
73968228|NCT03683719|147474449|SUPERIORITY||Mean Difference (Net)|-20.29|||<|0.0001|TWO_SIDED|95.0|-29.56|-11.02||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-11.02|-29.56|<0.0001
73924060|NCT01190254|147376825|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.0||||0.071|TWO_SIDED|95.0|-2.0|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-2.0|0.071
73924061|NCT01190254|147376825|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.8||||0.12|TWO_SIDED|95.0|-1.9|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-1.9|0.120
74087070|NCT02418455|147728179|SUPERIORITY||LS Mean|-0.57|STANDARD_ERROR_OF_MEAN|0.428||0.1792|TWO_SIDED|95.0|-1.41|0.26||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96||0.26|-1.41|0.1792
74087071|NCT02418455|147728179|SUPERIORITY||LS Mean|-0.35|STANDARD_ERROR_OF_MEAN|0.255||0.1731|TWO_SIDED|95.0|-0.85|0.15||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144||0.15|-0.85|0.1731
74087072|NCT02418455|147728180|SUPERIORITY||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.213||0.0843|TWO_SIDED|95.0|-0.78|0.05||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12||0.05|-0.78|0.0843
73862012|NCT00824005|147269930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.176|STANDARD_ERROR_OF_MEAN|0.845||0.361|TWO_SIDED|95.0|-0.56|0.21|||t-test, 2 sided|||Difference in the change in NYHA score between the two groups||0.21|-0.56|0.361
73862013|NCT00824005|147269931|SUPERIORITY_OR_OTHER||Difference in the proportion of particip|0.04|STANDARD_DEVIATION|0.045||0.28|TWO_SIDED|95.0|-0.01|0.09|||Chi-squared|||Difference in the change in anti-anginal meds across groups||0.09|-0.01|0.28
73862014|NCT00824005|147269932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|104.0|STANDARD_DEVIATION|409.0||0.302|TWO_SIDED|95.0|-95.0|303.0|||t-test, 2 sided|||Change in six minute walk distance||303|-95|0.302
73862015|NCT00824005|147269933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.7|STANDARD_DEVIATION|176.0||0.55|TWO_SIDED|95.0|-150.0|80.0|||t-test, 2 sided|||Difference in the change in BNP(reg) between cell and placebo group||80|-150|0.55
73862016|NCT00824005|147269934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.5|STANDARD_DEVIATION|31.2||0.198|TWO_SIDED|95.0|-5.03|23.93|||t-test, 2 sided|||Change in the difference of end diastolic volume between the two groups over time.||23.93|-5.03|0.198
73862017|NCT00824005|147269935|SUPERIORITY_OR_OTHER||Difference in the incidence rates|-0.047|STANDARD_ERROR_OF_MEAN|0.044||0.47|TWO_SIDED|95.0|-0.133|0.039|||t-test, 2 sided|||The difference in the incidence of major adverse cardiac events between the two groups over time. (Incidence rate)||0.039|-0.133|0.47
73862018|NCT00824005|147269936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|8.4||0.7|TWO_SIDED|95.0|-4.78|3.36|||t-test, 2 sided|||Difference in the change between the two groups||3.36|-4.78|0.7
73924062|NCT01190254|147376826|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.4||||0.263|TWO_SIDED|95.0|-1.2|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-1.2|0.263
73924063|NCT01190254|147376826|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.5||||0.146|TWO_SIDED|95.0|-1.3|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-1.3|0.146
73924064|NCT01190254|147376827|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.028|TWO_SIDED|95.0|1.1|3.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response|||3.6|1.1|0.028
73924065|NCT01190254|147376827|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.048|TWO_SIDED|95.0|1.0|3.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response|||3.3|1.0|0.048
73924066|NCT01190254|147376828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.576||||||p-value is for Log Rank test of difference in time to event (PANSS 30% response) curves between the three treatment groups|Log Rank|||||||0.576
73924067|NCT01190254|147376828|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3||||0.171|TWO_SIDED|95.0|0.9|2.0|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo|||2.0|0.9|0.171
73924068|NCT01190254|147376828|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2||||0.368|TWO_SIDED|95.0|0.8|1.8|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo|||1.8|0.8|0.368
73924069|NCT01190254|147376829|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.3||||0.094|TWO_SIDED|95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.0|-0.6|0.094
73924070|NCT01190254|147376829|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.5||||0.003|TWO_SIDED|95.0|-0.8|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.2|-0.8|0.003
73924071|NCT01190254|147376830|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||0.177|TWO_SIDED|95.0|0.8|2.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe \[Africa/Latin America sites assigned to this region\]) and treatment|OR was adjusted for region. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving CGI-I response|||2.8|0.8|0.177
73924072|NCT01190254|147376830|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.114|TWO_SIDED|95.0|0.9|2.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe \[Africa/Latin America sites assigned to this region\]) and treatment|OR was adjusted for region. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving CGI-I response|||2.9|0.9|0.114
73924073|NCT01190254|147376831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||||||p-value is for Log Rank test of difference in time to event (CGI-I response) curves between the three treatment groups|Log Rank|||||||0.057
74087073|NCT02418455|147728180|SUPERIORITY||LS Mean|-0.02|STANDARD_ERROR_OF_MEAN|0.513||0.9618|TWO_SIDED|95.0|-1.03|0.98||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24||0.98|-1.03|0.9618
73862019|NCT03458702|147269937|EQUIVALENCE|It would be expected at baseline that there were no differences between groups.|||||>|0.05|||||||t-test, 2 sided|||||||>.05
73862020|NCT03458702|147269937|SUPERIORITY||||||<|0.001|||||||ANOVA|||ANOVA for TIME||||<0.001
73862021|NCT03458702|147269938|EQUIVALENCE|It would be expected at baseline there would be no difference between groups.|||||>|0.05|||||||ANOVA|||||||>.05
73862022|NCT03458702|147269938|SUPERIORITY||||||<|0.001|||||||ANOVA|||ANOVA: Condition x Time Interaction||||<0.001
73862023|NCT03458702|147269938|SUPERIORITY|||||||0.005|||||||ANOVA|||ANOVA: TIME||||0.005
73862024|NCT03458702|147269939|EQUIVALENCE|It would be hypothesized that there would not be a difference at baseline.|||||>|0.05|||||||ANOVA|||||||> .05
73862025|NCT03458702|147269939|SUPERIORITY|||||||0.042|||||||ANOVA|||ANOVA: CONDITION X TIME INTERACTION||||0.042
74028596|NCT00958568|147610879|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.014
74028597|NCT00958568|147610879|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.054
74028598|NCT00958568|147610880|SUPERIORITY_OR_OTHER||LS Mean Difference|5.89|STANDARD_ERROR_OF_MEAN|1.87||0.002|TWO_SIDED|95.0|2.22|9.56||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||9.56|2.22|0.002
74028599|NCT00958568|147610881|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value is for Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.031
73924074|NCT01190254|147376831|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.4||||0.135|TWO_SIDED|95.0|0.9|2.3|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo|||2.3|0.9|0.135
74028600|NCT00958568|147610881|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
74087074|NCT02418455|147728180|SUPERIORITY||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.391||0.6954|TWO_SIDED|95.0|-0.92|0.61||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|GEE model|||Change at Week 48||0.61|-0.92|0.6954
74087075|NCT02418455|147728180|SUPERIORITY||LS Mean|0.22|STANDARD_ERROR_OF_MEAN|0.364||0.5492|TWO_SIDED|95.0|-0.5|0.93||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96||0.93|-0.50|0.5492
73924075|NCT01190254|147376831|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.8||||0.01|TWO_SIDED|95.0|1.2|2.9|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo|||2.9|1.2|0.010
73924076|NCT01190254|147376832|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.4||||0.417|TWO_SIDED|95.0|-2.0|4.8|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||4.8|-2.0|0.417
73924077|NCT01190254|147376832|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.2||||0.017|TWO_SIDED|95.0|0.8|7.6|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||7.6|0.8|0.017
73924078|NCT01190254|147376833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.6||||0.6|TWO_SIDED|95.0|-1.6|2.8|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||2.8|-1.6|0.600
73924079|NCT01190254|147376833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.1||||0.064|TWO_SIDED|95.0|-0.1|4.3|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||4.3|-0.1|0.064
73924080|NCT01190254|147376834|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.407|TWO_SIDED|95.0|-0.13|0.33|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||0.33|-0.13|0.407
73924081|NCT01190254|147376834|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.19||||0.111|TWO_SIDED|95.0|-0.04|0.42|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||0.42|-0.04|0.111
74028601|NCT00958568|147610881|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value is for Normal to Impaired. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.344
74028602|NCT00958568|147610881|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||P-value is for Normal/Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.072
74028603|NCT00958568|147610882|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|2.96|4.88||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||4.88|2.96|<0.001
74028604|NCT00958568|147610883|SUPERIORITY_OR_OTHER||||||<|0.001||||||The threshold for statistical significance was 0.05.|Fisher Exact|||||||<0.001
74028605|NCT00958568|147610884|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||P-value is for suicidal ideation. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.392
74028606|NCT00958568|147610885|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.95||0.421|TWO_SIDED|95.0|-5.42|2.27||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||2.27|-5.42|0.421
74028607|NCT01745055|147610902|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|103.06|||||TWO_SIDED|90.0|99.0|107.29||||||Natural log transformed, AUC (0-12) of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.29|99.00|
73924082|NCT02603809|147376835|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"||||<0.001
73924083|NCT02603809|147376835|SUPERIORITY||LS Mean|-1.31|STANDARD_ERROR_OF_MEAN|1.548||0.8117|TWO_SIDED|95.0|-5.1|2.49|||ANCOVA|with Dunnett correction.||||2.49|-5.10|0.8117
73924084|NCT02603809|147376835|SUPERIORITY||LS Mean|-4.93|STANDARD_ERROR_OF_MEAN|1.532||0.0053|TWO_SIDED|95.0|-8.68|-1.17|||ANCOVA|with Dunnett correction.||||-1.17|-8.68|0.0053
73924085|NCT02603809|147376835|SUPERIORITY||LS Mean|-6.99|STANDARD_ERROR_OF_MEAN|1.554|<|0.0001|TWO_SIDED|95.0|-10.8|-3.19|||ANCOVA|with Dunnett correction.||||-3.19|-10.80|<.0001
73924086|NCT02603809|147376835|SUPERIORITY||LS Mean|-4.95|STANDARD_ERROR_OF_MEAN|1.549||0.0057|TWO_SIDED|95.0|-8.75|-1.15|||ANCOVA|with Dunnett correction.||||-1.15|-8.75|0.0057
73924087|NCT02603809|147376836|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran-rprojects.org/web/packages/DoseFinding.)"||||<0.001
73924088|NCT02603809|147376836|SUPERIORITY||LS Mean|-2.45|STANDARD_ERROR_OF_MEAN|2.445||0.7071|TWO_SIDED|95.0|-8.44|3.54|||ANCOVA|with Dunnett correction.||||3.54|-8.44|0.7071
73924089|NCT02603809|147376836|SUPERIORITY||LS Mean|-7.05|STANDARD_ERROR_OF_MEAN|2.42||0.0138|TWO_SIDED|95.0|-12.98|-1.12|||ANCOVA|with Dunnett correction.||||-1.12|-12.98|0.0138
73924090|NCT02603809|147376836|SUPERIORITY||LS Mean|-9.9|STANDARD_ERROR_OF_MEAN|2.457||0.0003|TWO_SIDED|95.0|-15.92|-3.88|||ANCOVA|with Dunnett correction.||||-3.88|-15.92|0.0003
74087076|NCT02418455|147728180|SUPERIORITY||LS Mean|-0.56|STANDARD_ERROR_OF_MEAN|0.503||0.2618|TWO_SIDED|95.0|-1.55|0.42||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144||0.42|-1.55|0.2618
73924091|NCT02603809|147376836|SUPERIORITY||LS Mean|-7.58|STANDARD_ERROR_OF_MEAN|0.0077||0.0077|TWO_SIDED|95.0|-13.58|-1.59|||ANCOVA|with Dunnett correction.||||-1.59|-13.58|0.0077
73924092|NCT02603809|147376842|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"||||<0.001
73924093|NCT02603809|147376842|SUPERIORITY||LS Mean|-1.75|STANDARD_ERROR_OF_MEAN|1.401||0.5356|TWO_SIDED|95.0|-5.19|1.69|||ANCOVA|with Dunnett correction.||||1.69|-5.19|0.5356
73924094|NCT02603809|147376842|SUPERIORITY||LS Mean|-5.82|STANDARD_ERROR_OF_MEAN|1.396||0.0001|TWO_SIDED|95.0|-9.25|-2.4|||ANCOVA|with Dunnett correction.||||-2.40|-9.25|0.0001
73924095|NCT02603809|147376842|SUPERIORITY||LS Mean|-7.5|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-10.96|-4.04|||ANCOVA|with Dunnett correction.||||-4.04|-10.96|<.0001
73924096|NCT02603809|147376842|SUPERIORITY||LS Mean|-5.65|STANDARD_ERROR_OF_MEAN|1.41||0.0003|TWO_SIDED|95.0|-9.11|-2.19|||ANCOVA|with Dunnett correction.||||-2.19|-9.11|0.0003
73924097|NCT04729127|147376843|OTHER|||||||0.79|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.79
73924098|NCT04729127|147376843|OTHER|||||||0.27|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.27
73924099|NCT04729127|147376844|OTHER|||||||0.04|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.04
73924100|NCT04729127|147376844|OTHER|||||||0.02|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.02
73924101|NCT04729127|147376845|OTHER|||||||0.78|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.78
73924102|NCT04729127|147376845|OTHER|||||||0.89|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.89
73924103|NCT04729127|147376846|OTHER|||||||0.07|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.07
73924104|NCT04729127|147376846|OTHER|||||||0.88|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.88
73862026|NCT03458702|147269939|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||ANOVA: TIME||||<0.001
73924105|NCT04729127|147376849|OTHER|||||||0.26|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.26
74087077|NCT01557920|147728215|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||pathological swallows under anesthesia vs. wakefulness: 25.9% vs. 4.9%|Mixed Models Analysis|||||||0.001
73862027|NCT03458702|147269940|EQUIVALENCE|A difference at baseline was not expected.|||||>|0.05|||||||ANOVA|||||||>.05
73862028|NCT03458702|147269940|SUPERIORITY|||||||0.016|||||||ANOVA|||ANOVA: TIME||||0.016
73924106|NCT04729127|147376849|OTHER|||||||0.74|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.74
73924107|NCT00887354|147376851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean|0.04|||<|0.0001|TWO_SIDED|95.0|0.025|0.055|||Mixed Models Analysis|||||0.055|0.025|<.0001
73924108|NCT01010906|147376878|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for mild HI participants.|Geometric Least-Square Mean Ratio|1.82|||||TWO_SIDED|90.0|0.96|3.43||||||||3.43|0.96|
73924109|NCT01010906|147376878|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for moderate HI participants.|Geometric Least-Square Mean Ratio|3.11|||||TWO_SIDED|90.0|1.6|6.04||||||||6.04|1.60|
73924110|NCT01010906|147376878|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for severe HI participants.|Geometric Least-Square Mean Ratio|8.42|||||TWO_SIDED|90.0|5.2|13.64||||||||13.64|5.20|
73924111|NCT01010906|147376879|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|1.57|||||TWO_SIDED|90.0|0.76|3.24||||||||3.24|0.76|
73924112|NCT01010906|147376879|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|2.21|||||TWO_SIDED|90.0|1.21|4.03||||||||4.03|1.21|
73924113|NCT01010906|147376879|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|6.16|||||TWO_SIDED|90.0|3.9|9.71||||||||9.71|3.90|
73924114|NCT00525174|147376882|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Regression, Logistic|||Logistic regression was performed comparing the proportions of patients in each treatment group who had no improvement or worsening in amblyopic eye visual acuity from baseline to 24 weeks (change from baseline \<= +4 letters for E-ETDRS testing).||||0.02
73924115|NCT00525174|147376883|NON_INFERIORITY_OR_EQUIVALENCE|The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.|Mean Difference (Net)|0.38|||||ONE_SIDED|95.0||0.76|||ANCOVA|The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity.||The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.||0.76||
73924116|NCT00525174|147376883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.09|TWO_SIDED|95.0|-0.06|0.83|||ANCOVA|The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity.||In addition to the test of non-inferiority, an efficacy test of Patching over Bangerter filters was also completed.||0.83|-0.06|0.09
73924117|NCT00525174|147376883|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Mixed Models Analysis|||Treatment group difference in rate of improvement was evaluated using a population averaged linear mixed model after performing an inverse transformation of time to obtain linearity.||||0.20
73924118|NCT00525174|147376883|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|||The relationship between the fellow eye blur from the Bangerter filter at baseline and amblyopic improvement at the 24-week outcome was evaluated with an ANCOVA model with acuity in the fellow eye being categorized as better than versus equal to or worse than acuity in the amblyopic eye.||||0.49
73924119|NCT00525174|147376883|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|||The association of fixation preference while the Bangerter filter was over the fellow eye at baseline (amblyopic eye, fellow eye, alternates) with 24-week amblyopic eye acuity was evaluated in an ANCOVA model.||||0.21
73924120|NCT00525174|147376885|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic eye visual acuity within 1 line of the fellow eye or better.||||0.27
73968229|NCT03683719|147474449|SUPERIORITY||Mean Difference (Net)|-15.59|||<|0.01|TWO_SIDED|95.0|-24.82|-6.36||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-6.36|-24.82|<0.01
74087078|NCT01557920|147728215|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Comparison of pathological swallow-rate increase by carbon-dioxide during anesthesia and wakefulness||||<0.001
73862029|NCT03458702|147269941|EQUIVALENCE|no difference is expected at baseline|||||>|0.05|||||||ANOVA|||||||>.05
73924121|NCT00525174|147376886|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic visual acuity 20/25 or better at 24 weeks.||||0.86
73924122|NCT00525174|147376886|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Cox|||The time to first achieve amblyopic eye visual acuity of 20/25 or better was evaluated using a Cox proportional hazard model.||||0.28
73924123|NCT00525174|147376887|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients with 3 or more lines of amblyopic eye visual acuity improvement from baseline to 24 weeks.||||0.61
73924124|NCT00525174|147376890|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.||||0.90
73924125|NCT00525174|147376891|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.||||0.88
73924126|NCT00525174|147376893|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANCOVA|||A treatment group difference in the fellow eye visual acuity at 24 weeks was evaluated in an ANCOVA model adjusted for the baseline fellow eye acuity.||||0.07
74028608|NCT01745055|147610903|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|102.71|||||TWO_SIDED|90.0|93.79|112.47||||||Natural log transformed, Cmax of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||112.47|93.79|
74028609|NCT01745055|147610904|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|89.53|||||TWO_SIDED|90.0|77.38|103.57||||||Natural log transformed, AUClast of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||103.57|77.38|
73862030|NCT03458702|147269941|SUPERIORITY|||||||0.026|||||||ANOVA|||ANOVA:TIME||||0.026
73862031|NCT03458702|147269942|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|||||||<.05
73924127|NCT00525174|147376893|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Fisher Exact|||The Fisher exact test was used to compare the proportion of subjects in each treatment group who tested 2 or more logMAR lines worse in the fellow eye at 24 weeks compared with baseline.||||0.21
73924128|NCT00525174|147376894|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 6 weeks.||||0.03
73924129|NCT00525174|147376895|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 24 weeks.||||<0.001
73924130|NCT00525174|147376896|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 6 weeks.||||0.90
73924131|NCT00525174|147376897|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 24 weeks.||||0.01
73924132|NCT00525174|147376898|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 6 weeks.||||0.12
73924133|NCT00525174|147376899|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 24 weeks.||||0.001
73924134|NCT00525174|147376900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 6 weeks.||||<0.001
73924135|NCT00525174|147376901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 24 weeks.||||<0.001
73924136|NCT00914810|147376902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.55|TWO_SIDED|95.0|-0.8|1.5|||t-test, 2 sided|||||1.5|-0.8|0.55
74087079|NCT01557920|147728220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The number of swallows per hour: 1.7±3.3 during anesthesia vs. 28.0±22.3 during wakefulness|Mixed Models Analysis|||||||<0.001
73924137|NCT00914810|147376903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.5|||<|0.0001|TWO_SIDED|95.0|7.4|13.6|||t-test, 2 sided|||||13.6|7.4|<0.0001
73924138|NCT01327300|147376914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72||||0.001||95.0|||||t-test, 2 sided|||"The GIS scoring system is from 1-7 with one being a worse outcome and 7 the better outcome.~Comparisons below list the p values for comparison of difference in GIS between baseline and mesalamine."||||.001
73924139|NCT01327300|147376914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.008||95.0|||||t-test, 2 sided|||Comparisons of mean difference in GIS scores between baseline and placebo is made below.||||0.008
73924140|NCT01327300|147376915|SUPERIORITY_OR_OTHER|||||||0.873|||||||Wilcoxon (Mann-Whitney)|||Correlation coefficients were used for each of three biomarkers in relation to other biomarkers and to the questionnaires and patient's symptoms.||||0.873
73924141|NCT01327300|147376915|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|Pearson's linear coefficient||The study tested three biomarkers and symptom domains at baseline and the end of 12 weeks of placebo using the Mann-Whitney test, as well as correlations between domains with Pearson's linear correlation coefficient.||||0.810
73924142|NCT01327300|147376916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.5||||0.67|||||||t-test, 2 sided|Two-tailed P values are listed for baseline versus 12 weeks of mesalamine||"The FBDSI score is based on the severity of abdominal pian. Severity is rated as the following:~None= 0 points Mild= (1-36) Moderate =(37-110) Severe= (\>110 points)"||||0.67
73924143|NCT01327300|147376916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0||||0.77|||||||t-test, 2 sided|||See prior description of the FBDSI score. Change in the FBDSI after 12 weeks of intervention is made using a two sided t-test.||||0.77
73924144|NCT01327300|147376917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0||||0.61|||||||t-test, 2 sided|||For the IBS QOL we compared the change in IBS-Quality of Life (IBS-QOL) after 12 weeks of mesalamine.||||0.61
73924145|NCT01327300|147376917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2||||0.33|||||||t-test, 2 sided|||Comparison of change in IBS-Quality of Life (IBS-QOL)from baseline after 12 weeks of intervention was made.||||0.33
73924146|NCT01327300|147376918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.71||95.0|||||t-test, 2 sided|||Comparison of the change in HADS score of baseline to 12 weeks of mesalamine is made.||||0.71
73924147|NCT01327300|147376918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.57||95.0|||||t-test, 2 sided|||Comparison of change in HADS score between baseline and after 12 weeks of placebo is made.||||0.57
73924148|NCT01327300|147376919|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||Comparison of the lactulose/mannitol ratio is made after a 12 week intervention with mesalamine to 12 weeks of placebo.||||0.55
73924149|NCT02807350|147376924|OTHER||Risk Difference (RD)|19.0|||||TWO_SIDED|95.0|7.0|29.0||||||\>1 point analysis||29|7|
73924150|NCT02807350|147376924|OTHER|\>2 points analysis|Risk Difference (RD)|20.0|||||TWO_SIDED|95.0|10.0|28.0||||||||28|10|
73924151|NCT02807350|147376925|OTHER|\>1 analysis|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-7.0|15.0||||||||15|-7|
73924152|NCT02807350|147376925|OTHER|\>2 analysis|Risk Difference (RD)|8.0|||||TWO_SIDED|95.0|-2.0|17.0||||||||17|-2|
73924153|NCT02529137|147376973|NON_INFERIORITY|the non-inferiority margin was set at 4%|difference|0.4|||||TWO_SIDED|95.0|-0.3|1.01||||||||1.01|-0.30|
73924154|NCT03036098|147376980|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0032|TWO_SIDED|95.0|0.64|0.97|||Log Rank|Stratified weighted log-rank test||||0.97|0.64|0.0032
73924155|NCT03036098|147376987|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0018|TWO_SIDED|95.0|0.59|0.88|||Log Rank|Stratified weighted log-rank test||||0.88|0.59|0.0018
73924156|NCT03036098|147376988|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0171|TWO_SIDED|95.0|0.63|0.96|||Log Rank|Stratified weighted log-rank test||||0.96|0.63|0.0171
73924157|NCT03453684|147376992|OTHER||Overall SE of the estimate|0.009|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.45 Standard error of the estimate of w\^2: 0.39|||||
73924158|NCT03453684|147376993|OTHER||Overall Standard Error of the Estimate|9.85|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.61 Standard error of the estimate of ꙍ\^2 (intersubject variability): \^a (fixed to 0)|||||
73924159|NCT03453684|147376994|OTHER||Overall Standard Error of the Estimate|8.37|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.02 Standard error of the estimate of ꙍ\^2 (intersubject variability): \^a (fixed to 0)|||||
73924160|NCT03453684|147376995|OTHER||Overall Standard Error of the Estimate|4.83|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.003 Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.03|||||
73924161|NCT03453684|147376996|OTHER||Overall Standard Error of the Estimate|17.21|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.13|||||
73862032|NCT01874275|147269947|SUPERIORITY_OR_OTHER|||||||0.2413|TWO_SIDED||||||Mixed Models Analysis|||||||0.2413
74087080|NCT02075606|147728224|OTHER||Odds Ratio (OR)|0.17|||=|0.126|TWO_SIDED|95.0|0.02|1.65|||Regression, Logistic|||Clinical symptomatic response as dependent variable and CTC presence at baseline as explanatory variable was used to perform the logistic regression analysis.||1.65|0.02|=0.126
73862033|NCT00168103|147269955|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.525||||0.0025|TWO_SIDED|95.0|-2.217|-0.033||1-sided P-value. The a priori threshold was 0.024 (overall Type 1 error 0.025 adjusted for alpha spending for an interim analysis).|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodges-Lehmann estimate.|||-0.033|-2.217|0.0025
73862034|NCT00168103|147269956|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1088||||0.0014|TWO_SIDED|80.0|0.0392|0.3023||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Fisher Exact|1-sided|The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|Worsened intensity was evaluated between 2 and 4 hours after start of study treatment relative to baseline for at least 1 of the HAE symptoms present at baseline.||0.3023|0.0392|0.0014
73862035|NCT00168103|147269957|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.292||||0.0237|TWO_SIDED|80.0|-5.15|-1.05||1-sided, exploratory test.|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodge-Lehmann estimate.|This was an exploratory analysis.||-1.050|-5.150|0.0237
73862036|NCT00168103|147269958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1714|||||TWO_SIDED|95.0|0.0642|0.4575|||||The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|This was an exploratory analysis.||0.4575|0.0642|
73862037|NCT00168103|147269959|SUPERIORITY_OR_OTHER|||||||0.0329|TWO_SIDED|80.0||||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Wilcoxon (Mann-Whitney)|1-sided||||||0.0329
73862038|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted difference|0.18|||||TWO_SIDED|95.0|-0.11|0.46|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 29||0.46|-0.11|
73862039|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.09|||||TWO_SIDED|95.0|-0.34|0.17|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 57||0.17|-0.34|
73862040|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.08|||||TWO_SIDED|95.0|-0.37|0.2|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 85||0.20|-0.37|
73862041|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.23|||||TWO_SIDED|95.0|-0.5|0.04|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 113||0.04|-0.50|
73862042|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|0.03|||||TWO_SIDED|95.0|-0.26|0.32|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 141||0.32|-0.26|
73862043|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.13|||||TWO_SIDED|95.0|-0.41|0.15|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 169||0.15|-0.41|
73862044|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.12|||||TWO_SIDED|95.0|-0.38|0.13|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 197||0.13|-0.38|
73862045|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.04|||||TWO_SIDED|95.0|-0.32|0.25|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 225||0.25|-0.32|
74087081|NCT02310763|147728249|SUPERIORITY||Mean Difference (Net)|1.293|STANDARD_ERROR_OF_MEAN|1.022||0.2088|TWO_SIDED|95.0|-0.7343|3.32||The significance level is 0.05.|ANCOVA||Least square mean difference was calculated by placebo minus domagrozumab.|||3.3200|-0.7343|0.2088
73862046|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|0.08|||||TWO_SIDED|95.0|-0.19|0.36|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 253||0.36|-0.19|
73862047|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|0.13|||||TWO_SIDED|95.0|-0.12|0.38|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 281||0.38|-0.12|
73862048|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.03|||||TWO_SIDED|95.0|-0.27|0.22|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 309||0.22|-0.27|
73862049|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.03|||||TWO_SIDED|95.0|-0.37|0.31|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 337||0.31|-0.37|
73862050|NCT00989235|147269962|SUPERIORITY_OR_OTHER||Adjusted Difference|0.23|||||TWO_SIDED|95.0|-0.09|0.55|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 365||0.55|-0.09|
73862051|NCT00989235|147269963|SUPERIORITY_OR_OTHER||estimate of difference|0.4|||||TWO_SIDED|95.0|-17.2|18.0|||normal approximation|For 95% CI: normal approximation with continuity correction.||||18.0|-17.2|
73862052|NCT00989235|147269964|SUPERIORITY_OR_OTHER||estimate of difference|-8.6|||||TWO_SIDED|95.0|-20.3|3.2|||normal approximation|For 95% CI: normal approximation with continuity correction.||||3.2|-20.3|
73862053|NCT00989235|147269966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.45|1.69|||Cox proportional hazards model||Hazard ratio determined by a Cox proportional hazards model with treatment as the only covariate.|Through Month 12||1.69|0.45|
73924162|NCT03453684|147376997|OTHER||SE of the estimate of Typical Value|0.2|||||TWO_SIDED|||||||||||||
73924163|NCT03453684|147376998|OTHER||SE of the estimate of Typical Value|2.1|||||TWO_SIDED||||||||Standard error of the estimate of Typical value should be read as: 2.1E-06 Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.24|||||
73924164|NCT03453684|147376999|OTHER||SE of the estimate of Typical Value|2.3|||||TWO_SIDED||||||||Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.08|||||
73924165|NCT03453684|147377000|OTHER||Overall Standard Error of the Estimate|10.8|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.02|||||
73924166|NCT03453684|147377001|OTHER||SE of the estimate of Typical Value|0.9|||||TWO_SIDED|||||||||||||
74087082|NCT02310763|147728253|SUPERIORITY||Mean Difference (Net)|-0.0845||||0.9191|TWO_SIDED|95.0|-1.7354|1.5663||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||1.5663|-1.7354|0.9191
74087083|NCT02310763|147728253|SUPERIORITY||Mean Difference (Net)|0.5837||||0.7642|TWO_SIDED|95.0|-3.2978|4.4652||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.4652|-3.2978|0.7642
74087084|NCT02310763|147728253|SUPERIORITY||Mean Difference (Net)|0.2712||||0.9423|TWO_SIDED|95.0|-7.3799|7.9223||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||7.9223|-7.3799|0.9423
74087085|NCT02310763|147728254|SUPERIORITY||Mean Difference (Net)|0.0||||0.9993|TWO_SIDED|95.0|-0.0693|0.0693||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||0.0693|-0.0693|0.9993
73924167|NCT02063854|147377002|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.1346|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.||||||0.1346
73924168|NCT02063854|147377002|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.6711|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.||||||0.6711
73924169|NCT02063854|147377002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.92|0.001||||||||0.001|-1.920|
73924170|NCT02063854|147377002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-2.617|-0.794||||||||-0.794|-2.617|
73924171|NCT02063854|147377002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||||TWO_SIDED|95.0|-0.166|1.658||||||||1.658|-0.166|
73924172|NCT03538158|147377013|SUPERIORITY||Slope|5.7||||0.82|TWO_SIDED|95.0|-287.7|299.1|||Mixed Models Analysis|F(2,131)=.07||||299.1|-287.7|.82
74087086|NCT02310763|147728254|SUPERIORITY||Mean Difference (Net)|-0.0259||||0.5464|TWO_SIDED|95.0|-0.1107|0.0589||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||0.0589|-0.1107|0.5464
74087087|NCT02310763|147728254|SUPERIORITY||Mean Difference (Net)|-0.042||||0.3041|TWO_SIDED|95.0|-0.1227|0.0386||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||0.0386|-0.1227|0.3041
74087088|NCT02310763|147728255|SUPERIORITY||Mean Difference (Net)|0.8||||0.3522|TWO_SIDED|95.0|-0.9|2.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||2.5|-0.9|0.3522
74087089|NCT02310763|147728255|SUPERIORITY||Mean Difference (Net)|2.5||||0.0061|TWO_SIDED|95.0|0.7|4.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.2|0.7|0.0061
74087090|NCT02310763|147728255|SUPERIORITY|Week 49|Mean Difference (Net)|1.6||||0.1268|TWO_SIDED|95.0|-0.5|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|||3.8|-0.5|0.1268
74087091|NCT02310763|147728256|SUPERIORITY||Mean Difference (Net)|-0.4||||0.7337|TWO_SIDED|95.0|-2.9|2.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 17||2.1|-2.9|0.7337
74087092|NCT02310763|147728256|SUPERIORITY||Mean Difference (Net)|0.2||||0.8893|TWO_SIDED|95.0|-2.4|2.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 33||2.7|-2.4|0.8893
74087093|NCT02310763|147728256|SUPERIORITY||Mean Difference (Net)|-1.5||||0.2939|TWO_SIDED|95.0|-4.3|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 49||1.3|-4.3|0.2939
74087094|NCT02310763|147728256|SUPERIORITY||Mean Difference (Net)|0.8||||0.5995|TWO_SIDED|95.0|-2.1|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 17||3.6|-2.1|0.5995
74087095|NCT02310763|147728256|SUPERIORITY||Mean Difference (Net)|2.9||||0.0385|TWO_SIDED|95.0|0.2|5.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 33||5.6|0.2|0.0385
73924173|NCT03538158|147377014|SUPERIORITY||Slope|0.5||||0.97|TWO_SIDED|95.0|-3.5|4.4|||Mixed Models Analysis|F(2,75)=.03||||4.4|-3.5|.97
73924174|NCT00525733|147377035|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Chi-squared|||||||0.46
73924175|NCT02188589|147377056|EQUIVALENCE|The difference between the mean baseline and mean follow-up NOSE scores was evaluated by paired t-test with significance indicated by p\<0.05.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73924176|NCT00878709|147377073|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.008|TWO_SIDED|95.0|0.49|0.9|||Log Rank|The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.||0.90|0.49|0.008
73924177|NCT00878709|147377075|SUPERIORITY||Hazard Ratio (HR)|0.952||||0.6914|TWO_SIDED|95.0|0.747|1.212|||Log Rank|||The 2-sided P-value was based on stratified log-rank test (stratification factors: prior Trastuzumab (concurrent or sequential), nodal status (\<=3 or \>=4) and ER/PgR status (positive or negative). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.212|0.747|0.6914
73924178|NCT00878709|147377076|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.45|0.83|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Disease-free survival including ductal carcinoma in situ (DFS-DCIS) in neratinib arm compared to placebo arm.||0.83|0.45|
73924179|NCT00878709|147377078|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.05|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Distant disease free survival (DDFS) in neratinib arm compared to placebo arm.||1.05|0.52|
73924180|NCT00878709|147377080|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.51|1.04|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Time to distant recurrence (TTDR) in neratinib arm compared to placebo arm.||1.04|0.51|
73924181|NCT00878709|147377084|OTHER||Hazard Ratio (HR)|0.73||||0.008|TWO_SIDED|95.0|0.57|0.92||The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Log Rank||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.||0.92|0.57|0.008
74087096|NCT02310763|147728256|SUPERIORITY||Mean Difference (Net)|0.0||||0.9927|TWO_SIDED|95.0|-3.3|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 49||3.2|-3.3|0.9927
73862054|NCT00989235|147269967|SUPERIORITY_OR_OTHER||estimate of difference|-1.1|||||TWO_SIDED|95.0|-12.9|10.7|||normal approximation|For 95% CI: normal approximation with continuity correction.||||10.7|-12.9|
73924182|NCT00878709|147377086|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.56|0.89|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||0.89|0.56|
73924183|NCT00878709|147377087|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||1.01|0.6|
73924184|NCT00878709|147377088|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.6|1.03|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||1.03|0.60|
73924185|NCT00768300|147377099|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.66||P-value was based on a stratified log-rank test with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable usual interstitial pneumonia (UIP) based on core pathology review.|Log Rank||The hazard ratio was based on a stratified Cox proportional hazards model with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable UIP based on core pathology review.|||2.66|1.14|0.010
73924186|NCT00768300|147377101|SUPERIORITY_OR_OTHER||Point estimate|4.29||||0.086|TWO_SIDED|95.0|-0.805|9.376||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% confidence interval (CI) were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||9.376|-0.805|0.086
73924187|NCT00768300|147377102|SUPERIORITY_OR_OTHER||Point estimate|2.85||||0.25|TWO_SIDED|95.0|-2.2|7.9||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and its 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||7.90|-2.20|0.250
74028610|NCT01745055|147610905|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|87.25|||||TWO_SIDED|90.0|76.03|100.12||||||Natural log transformed, Cmax of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||100.12|76.03|
74028611|NCT04498910|147610916|SUPERIORITY||Difference in Estimated change|-1.1|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.0|-3.6|1.2|||Bayesian Mixed Model Analysis|||||1.2|-3.6|
74087097|NCT02310763|147728257|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6049|TWO_SIDED|95.0|-1.7|1.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||1.0|-1.7|0.6049
73862055|NCT00989235|147269968|SUPERIORITY_OR_OTHER||estimate of difference|-7.7|||||TWO_SIDED|95.0|-22.6|7.3|||normal approximation|95% CI: normal approximation with continuity correction.||||7.3|-22.6|
73924188|NCT00768300|147377103|SUPERIORITY_OR_OTHER||Point estimate|16.0||||0.15|TWO_SIDED|95.0|-5.0|37.0||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||37.00|-5.00|0.150
73924189|NCT00768300|147377106|SUPERIORITY_OR_OTHER||Point estimate|0.5||||0.793|TWO_SIDED|95.0|0.0|1.0||The p-value was based on a Wilcoxon rank sum test stratified by baseline pulmonary hypertension (Yes/No) and surgical lung biopsy was performed with definite or probable UIP based on core pathology review (Yes/No).|Wilcoxon (Mann-Whitney)||The point estimate and 95% confidence interval were based on the Hodges-Lehmann Estimate of treatment effect|||1.00|0.00|0.793
73924190|NCT00651755|147377155|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.2|||||TWO_SIDED|90.0|1.08|1.33|||90% CI||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,CP, between Aprepitant treatment to control Group.|||1.33|1.08|
73924191|NCT00651755|147377156|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|ratio Geometric mean AUC|0.75|STANDARD_DEVIATION|0.29|||TWO_SIDED|95.0|0.65|0.86|||equivalence analysis||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group|||0.86|0.65|
74028612|NCT04498910|147610917|SUPERIORITY||Difference in Estimated change|-1.5|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-4.2|1.0|||Bayesian Mixed Model Analysis|||||1.0|-4.2|
74028613|NCT00909090|147610923|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
74028614|NCT00909090|147610924|SUPERIORITY|||||||0.21|||||||Regression, Linear|||Analysis compared mean differences between placebo and intervention at the 12-month time point.||||0.21
74028615|NCT00909090|147610925|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||Analysis compared mean change from baseline to 12-month time points.||||0.01
74028616|NCT00909090|147610926|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||analysis conducted on mean change over one year, between groups||||0.02
74028617|NCT00611455|147610932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86|||<|0.001|TWO_SIDED|95.0|1.67|4.91|||Cochran-Mantel-Haenszel|||||4.91|1.67|<0.001
73924192|NCT00651755|147377157|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|0.97|STANDARD_DEVIATION|0.35|||TWO_SIDED|90.0|0.83|1.13|||equivalence analysis|The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment to the control group|Ratio Geometric Mean AUC of Analyte, 4-OHCP, between Aprepitant treatment to control Group|||1.13|0.83|
73924193|NCT00651755|147377158|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.04|STANDARD_DEVIATION|0.68|||TWO_SIDED|90.0|0.82|1.33|||equivalence analysis||Ratio Geometric Mean AUC (Area Under Curve) of Analyte, VC, Between Aprepitant treatment to control Group.|||1.33|0.82|
73924194|NCT00651755|147377159|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.08|STANDARD_DEVIATION|0.17||||90.0|1.02|1.15|||equivalence analysis||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group.|||1.15|1.02|
73924195|NCT00651755|147377160|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.16|STANDARD_DEVIATION|0.47|||TWO_SIDED|90.0|1.01|1.32|||equivalence analysis||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,PL, Between Aprepitant treatment to control Group.|||1.32|1.01|
73924196|NCT02404285|147377161|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73968230|NCT03683719|147474450|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.05||||||"IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.05
74087098|NCT02310763|147728257|SUPERIORITY||Mean Difference (Net)|1.7||||0.2065|TWO_SIDED|95.0|-1.0|4.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.4|-1.0|0.2065
74087099|NCT02310763|147728257|SUPERIORITY||Mean Difference (Net)|0.0||||0.9391|TWO_SIDED|95.0|-1.3|1.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||1.2|-1.3|0.9391
73924197|NCT02404285|147377163|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73924198|NCT00624052|147377175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||||95.0|0.47|1.66|||Cochran-Mantel-Haenszel|||||1.66|0.47|
73924199|NCT00624052|147377175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28||||||95.0|0.14|0.59|||Cochran-Mantel-Haenszel|||||0.59|0.14|
73924200|NCT00624052|147377175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||||95.0|0.12|0.48|||Cochran-Mantel-Haenszel|||||0.48|0.12|
73924201|NCT00624052|147377175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||||95.0|0.17|0.59|||Cochran-Mantel-Haenszel|||||0.59|0.17|
73924202|NCT00624052|147377175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||||95.0|0.15|0.49|||Cochran-Mantel-Haenszel|||||0.49|0.15|
73924203|NCT00624052|147377175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||||95.0|0.42|1.68|||Cochran-Mantel-Haenszel|||||1.68|0.42|
73924204|NCT01286012|147377193|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
73924205|NCT01286012|147377194|SUPERIORITY_OR_OTHER|||||||0.915|||||||Cochran-Mantel-Haenszel|||||||0.915
73924206|NCT01286012|147377195|SUPERIORITY_OR_OTHER|||||||0.6714|||||||Cochran-Mantel-Haenszel|||||||0.6714
73924207|NCT01286012|147377196|SUPERIORITY_OR_OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
73924208|NCT01286012|147377197|SUPERIORITY_OR_OTHER|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
73968231|NCT03683719|147474450|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||>|0.1||||||"IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||>0.1
73968232|NCT03683719|147474450|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.0001||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.0001
73968233|NCT03683719|147474450|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.01||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.01
73968234|NCT05081583|147474451|OTHER||AUC ratio (geometric mean)|0.88|||||TWO_SIDED|90.0|0.82|0.96||||||The predefined no effect range was 0.80-1.25; that is, if the geometric mean ratio lay outside this range, a pharmacokinetic interaction was evident.||0.96|0.82|
73862056|NCT00989235|147269969|SUPERIORITY_OR_OTHER||estimate of difference|-10.6|||||TWO_SIDED|95.0|-31.1|10.0|||normal approximation|95% CI: normal approximation with continuity correction.||||10.0|-31.1|
73862057|NCT02266875|147270037|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
73924209|NCT00663052|147377205|SUPERIORITY_OR_OTHER||Proportion difference|18.34||||0.0015|TWO_SIDED|95.0|6.8|29.88|||Fisher Exact||Primary endpoint used 95% CI to compare to prespecified target rates for each treatment arm.|With 125 participants/group, estimation was: 1)approximately 90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 50% in ETN 50 mg QW, assuming true rate is 65% or greater; 2)90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 60% in 50 mg BIW, assuming true rate is 74% or greater. The 95% CI widths on these are approximately ±8.8%, indicating PASI 75 for ETN 50 mg QW and ETN 50 mg BIW must be at least 58.8% \& 68.8%, respectively to reject null hypotheses.||29.88|6.80|0.0015
73924210|NCT00663052|147377206|SUPERIORITY_OR_OTHER||Proportion difference|3.14||||0.3605|TWO_SIDED|95.0|-3.88|10.16|||Fisher Exact|||Comparison between treatment groups at Week 2||10.16|-3.88|0.3605
73924211|NCT00663052|147377206|SUPERIORITY_OR_OTHER||Proportion difference|17.91||||0.0013|TWO_SIDED|95.0|6.5|29.32|||Fisher Exact|||Comparison between treatment groups at Week 4||29.32|6.50|0.0013
73924212|NCT00663052|147377206|SUPERIORITY_OR_OTHER||Proportion difference|19.6||||0.0011|TWO_SIDED|95.0|7.51|31.7|||Fisher Exact|||Comparison between treatment groups at Week 8||31.70|7.51|0.0011
73924213|NCT00663052|147377206|SUPERIORITY_OR_OTHER||Proportion difference|20.09|||<|0.0001|TWO_SIDED|95.0|9.77|30.4|||Fisher Exact|||Comparison between treatment groups at Week 12||30.40|9.77|<.0001
73968235|NCT05081583|147474452|OTHER|The predefined no effect range was 0.80-1.25; that is, if the geometric mean ratio lay outside this range, a pharmacokinetic interaction was evident.|Cmax ratio (geometric mean)|0.93|||||TWO_SIDED|90.0|0.85|1.01||||||||1.01|0.85|
74028618|NCT00062738|147611026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.05|TWO_SIDED|95.0|0.8|15.9|||Fisher Exact|||For the responder analysis, an LOCF approach was used in which a clinical response was operationally defined as at least a 50% reduction in the HAM-D score from baseline to 8 weeks. Clinical response was cross-tabulated with treatment and Fisher exact test was used to distinguish differences among these groups.||15.9|0.8|<.05
74028619|NCT01507545|147611028|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.7335|TWO_SIDED|95.0|0.76|1.67|||One-sided log-rank test|||||1.67|0.76|0.7335
74028620|NCT01507545|147611029|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.9498|TWO_SIDED|95.0|0.93|2.19|||One-sided log-rank test|||||2.19|0.93|0.9498
74028621|NCT01507545|147611030|SUPERIORITY||Difference of arms|-2.4||||0.333|TWO_SIDED|95.0|-6.992|2.23|||Fisher Exact|||||2.230|-6.992|0.333
74087100|NCT02310763|147728258|SUPERIORITY||Mean Difference (Net)|1.8||||0.8499|TWO_SIDED|95.0|-16.7|20.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||20.3|-16.7|0.8499
73862058|NCT02266875|147270038|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
73924214|NCT00663052|147377206|SUPERIORITY_OR_OTHER||Proportion difference|14.38||||0.001|TWO_SIDED|95.0|5.39|23.37|||Fisher Exact|||Comparison between treatment groups at Week 16||23.37|5.39|0.0010
73924215|NCT00663052|147377206|SUPERIORITY_OR_OTHER||Proportion difference|10.75||||0.0087|TWO_SIDED|95.0|2.35|19.16|||Fisher Exact|||Comparison between treatment groups at Week 20||19.16|2.35|0.0087
73924216|NCT00663052|147377206|SUPERIORITY_OR_OTHER||Proportion difference|11.46||||0.0068|TWO_SIDED|95.0|2.77|20.15|||Fisher Exact|||Comparison between treatment groups at Week 24||20.15|2.77|0.0068
73924217|NCT00663052|147377207|SUPERIORITY_OR_OTHER||Proportion difference|1.5||||0.2435|TWO_SIDED|95.0|-1.31|4.32|||Fisher Exact|||Comparison between treatment groups at Week 2||4.32|-1.31|0.2435
73924218|NCT00663052|147377207|SUPERIORITY_OR_OTHER||Proportion difference|1.64||||0.5929|TWO_SIDED|95.0|-4.4|7.67|||Fisher Exact|||Comparison between treatment groups at Week 4||7.67|-4.40|0.5929
73924219|NCT00663052|147377207|SUPERIORITY_OR_OTHER||Proportion difference|13.44||||0.0156|TWO_SIDED|95.0|2.02|24.86|||Fisher Exact|||Comparison between treatment groups at Week 8||24.86|2.02|0.0156
73924220|NCT00663052|147377207|SUPERIORITY_OR_OTHER||Proportion difference|25.18|||<|0.0001|TWO_SIDED|95.0|12.89|37.47|||Fisher Exact|||Comparison between treatment groups at Week 12||37.47|12.89|<.0001
73968236|NCT05081583|147474453|OTHER||Half-life ratio (geometric mean)|1.01|||||TWO_SIDED|90.0|0.93|1.07||||||||1.07|0.93|
73862059|NCT02312765|147270054|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
73862060|NCT02481713|147270055|NON_INFERIORITY|All analyses were two-tailed with alpha set at 0.05||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
73862061|NCT02481713|147270056|SUPERIORITY||Risk Ratio (RR)|1.46||||0.0001|TWO_SIDED|95.0|1.25|1.69|||Regression, zero-inflated Poisson|||||1.69|1.25|.0001
73924221|NCT00663052|147377207|SUPERIORITY_OR_OTHER||Proportion difference|21.84||||0.0003|TWO_SIDED|95.0|9.82|33.85|||Fisher Exact|||Comparison between treatment groups at Week 16||33.85|9.82|0.0003
73924222|NCT00663052|147377207|SUPERIORITY_OR_OTHER||Proportion difference|19.8||||0.0006|TWO_SIDED|95.0|8.23|31.38|||Fisher Exact|||Comparison between treatment groups at Week 20||31.38|8.23|0.0006
73924223|NCT00663052|147377207|SUPERIORITY_OR_OTHER||Proportion difference|18.34||||0.0015|TWO_SIDED|95.0|6.8|29.88|||Fisher Exact|||Comparison between treatment groups at Week 24||29.88|6.80|0.0015
73924224|NCT00663052|147377208|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74||The P-value at Week 2 was not applicable as the percentage of participants achieving 90% improvement in PASI in both treatment groups were 0%.|Fisher Exact|||Comparison between treatment groups at Week 2||0.74|-0.74|
73968237|NCT05081583|147474454|OTHER||Renal clearance ratio (geometric mean)|0.97|||||TWO_SIDED|90.0|0.84|1.12||||||||1.12|0.84|
73968238|NCT05081583|147474455|OTHER||AUC ratio (geometric mean)|0.97|||||TWO_SIDED|90.0|0.81|1.15||||||||1.15|0.81|
73968239|NCT03056040|147474462|NON_INFERIORITY|A difference in percent change in LDH between the ravulizumab and eculizumab treatment groups at Day 183 along with a 2-sided 95% confidence interval (CI) was calculated. Noninferiority margin (NIM) was based on the upper bound of the 95% CI. NIM was 15%.|Treatment Difference|-9.21|||||TWO_SIDED|95.0|-18.84|0.42|||||Treatment difference was estimated for ravulizumab - eculizumab.|Adjusting for a possible 10% dropout rate, a minimum of 192 participants were estimated to provide 90% power to demonstrate noninferiority of ravulizumab to eculizumab.||0.42|-18.84|
73924225|NCT00663052|147377208|SUPERIORITY_OR_OTHER||Proportion difference|0.02||||1|TWO_SIDED|95.0|-2.77|2.81|||Fisher Exact|||Comparison between treatment groups at Week 4||2.81|-2.77|1.0000
73924226|NCT00663052|147377208|SUPERIORITY_OR_OTHER||Proportion difference|3.94||||0.2611|TWO_SIDED|95.0|-3.2|11.07|||Fisher Exact|||Comparison between treatment groups at Week 8||11.07|-3.20|0.2611
73924227|NCT00663052|147377208|SUPERIORITY_OR_OTHER||Proportion difference|18.37||||0.0002|TWO_SIDED|95.0|8.3|28.45|||Fisher Exact|||Comparison between treatment groups at Week 12||28.45|8.30|0.0002
73968240|NCT03056040|147474463|NON_INFERIORITY|NIM was based on the upper bound of the 95% CI. NIM was 20%.|Treatment Difference|-5.1|||||TWO_SIDED|95.0|-18.99|8.89|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with BTH was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.||8.89|-18.99|
73968241|NCT03056040|147474464|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM margin was -3.|Treatment Difference|1.47|||||TWO_SIDED|95.0|-0.21|3.15|||||Treatment difference was estimated for ravulizumab - eculizumab.|||3.15|-0.21|
73968242|NCT03056040|147474465|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|5.5|||||TWO_SIDED|95.0|-4.27|15.68|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants achieving transfusion avoidance was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug||15.68|-4.27|
74028622|NCT01753518|147611053|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.053
74028623|NCT01753518|147611054|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
74028624|NCT01753518|147611055|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Fisher Exact|||Comparison for staple expulsion or suture trimming||||0.25
74028625|NCT01753518|147611055|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Fisher Exact|||Comparison for Surgical Site Infection||||0.06
74028626|NCT01753518|147611055|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Fisher Exact|||Comparison for Superficial Wound Separation||||0.21
74087101|NCT02310763|147728258|SUPERIORITY||Mean Difference (Net)|8.9||||0.4008|TWO_SIDED|95.0|-12.0|29.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||29.8|-12.0|0.4008
73924228|NCT00663052|147377208|SUPERIORITY_OR_OTHER||Proportion difference|17.31||||0.0031|TWO_SIDED|95.0|5.43|29.19|||Fisher Exact|||Comparison between treatment groups at Week 16||29.19|5.43|0.0031
73924229|NCT00663052|147377208|SUPERIORITY_OR_OTHER||Proportion difference|15.92||||0.0081|TWO_SIDED|95.0|3.8|28.04|||Fisher Exact|||Comparison between treatment groups at Week 20||28.04|3.80|0.0081
73968243|NCT03056040|147474466|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|1.4|||||TWO_SIDED|95.0|-10.41|13.31|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with stabilized hemoglobin was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.||13.31|-10.41|
73924230|NCT00663052|147377208|SUPERIORITY_OR_OTHER||Proportion difference|16.78||||0.0064|TWO_SIDED|95.0|4.46|29.1|||Fisher Exact|||Comparison between treatment groups at Week 24||29.10|4.46|0.0064
73924231|NCT00663052|147377209|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74||The P-value at Week 2 was to be calculated by Fisher Exact method but was not estimable as the percentage of participants achieving 100% improvement in PASI in both treatment groups were 0%.||||Comparison between treatment groups at Week 2||0.74|-0.74|
73924232|NCT00663052|147377209|SUPERIORITY_OR_OTHER||Proportion difference|-0.73||||1|TWO_SIDED|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4||1.44|-2.90|1.0000
73924233|NCT00663052|147377209|SUPERIORITY_OR_OTHER||Proportion difference|-1.46||||0.4983|TWO_SIDED|95.0|-4.21|1.29|||Fisher Exact|||Comparison between treatment groups at Week 8||1.29|-4.21|0.4983
73924234|NCT00663052|147377209|SUPERIORITY_OR_OTHER||Proportion difference|1.57||||0.4957|TWO_SIDED|95.0|-3.23|6.37|||Fisher Exact|||Comparison between treatment groups at Week 12||6.37|-3.23|0.4957
74028627|NCT01753518|147611055|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Fisher Exact|||Comparison for Seroma||||0.49
74028628|NCT01753518|147611055|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Fisher Exact|||Comparison for Hematoma||||0.50
74028629|NCT01753518|147611056|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Tylenol use.||||0.48
74028630|NCT01753518|147611056|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Ibuprofen use.||||0.30
74028631|NCT01753518|147611056|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Toradol use.||||0.85
74028632|NCT01753518|147611056|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Oxycodone use.||||0.78
74028633|NCT01753518|147611058|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Fisher Exact|||"Comparison for negative responses to Appearance of incision question."||||0.51
74028634|NCT01753518|147611058|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Chi-squared|||"Comparison for negative responses to Would recommend treatment to friends question."||||0.098
74028635|NCT01753518|147611058|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Chi-squared|||"Comparison of negative responses to Willingness to use treatment again question."||||0.57
74028636|NCT01753518|147611058|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Fisher Exact|||"Comparison of negative responses to Overall satisfaction question."||||0.41
74028637|NCT01753518|147611059|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Chi-squared|||"Comparison between arms for appearance of incision."||||0.85
74028638|NCT01753518|147611059|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Chi-squared|||"Comparison between arms for recommend treatment."||||0.004
74028639|NCT01753518|147611059|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"Comparison between arms for willingness to use treatment again."||||<0.001
74028640|NCT01753518|147611060|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73862062|NCT04375397|147270074|SUPERIORITY||Adjusted risk difference (%)|5.8|||=|0.599|TWO_SIDED|80.0|-9.2|20.4|||Miettinen-Nurminen method||Ibrutinib 420 mg + SOC - Placebo + SOC Miettinen-Nurminen (MN) CI for the adjusted risk difference across strata|The difference in response rates between the experimental arm and the control arm were analyzed using the Miettinen-Nurminen (MN) method, adjusting for the stratification factor of prescription for remdesivir. The MN test p-value for testing the rate difference = 0 at two-sided alpha = 0.2.||20.4|-9.2|=0.599
73862063|NCT04375397|147270074|SUPERIORITY||Adjusted risk difference (%)|5.8|||=|0.599|TWO_SIDED|95.0|-18.1|28.7|||Miettinen-Nurminen method||Ibrutinib 420 mg + SOC - Placebo + SOC Miettinen-Nurminen (MN) CI for the adjusted risk difference across strata|The difference in response rates between the experimental arm and the control arm were analyzed using the Miettinen-Nurminen (MN) method, adjusting for the stratification factor of prescription for remdesivir. The MN test p-value for testing the rate difference = 0 at twosided alpha = 0.2.||28.7|-18.1|=0.599
73862064|NCT04375397|147270075|SUPERIORITY||Odds Ratio (OR)|1.17|||=|0.886|TWO_SIDED|95.0|0.13|10.44|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -3~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||10.44|0.13|=0.886
73924235|NCT00663052|147377209|SUPERIORITY_OR_OTHER||Proportion difference|3.14||||0.3115|TWO_SIDED|95.0|-3.24|9.52|||Fisher Exact|||Comparison between treatment groups at Week 16||9.52|-3.24|0.3115
73924236|NCT00663052|147377209|SUPERIORITY_OR_OTHER||Proportion difference|6.99||||0.0773|TWO_SIDED|95.0|-1.13|15.1|||Fisher Exact|||Comparison between treatment groups at Week 20||15.10|-1.13|0.0773
73924237|NCT00663052|147377209|SUPERIORITY_OR_OTHER||Proportion difference|5.53||||0.183|TWO_SIDED|95.0|-2.82|13.87|||Fisher Exact|||Comparison between treatment groups at Week 24||13.87|-2.82|0.1830
73924238|NCT00663052|147377210|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.3||||0.0103|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||-0.3|-2.3|0.0103
73924239|NCT00663052|147377210|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.8||||0.0031|TWO_SIDED|95.0|-3.0|-0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.6|-3.0|0.0031
74028641|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar painful.||||0.35
74028642|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar itching.||||0.48
73862065|NCT04375397|147270075|SUPERIORITY||Odds Ratio (OR)|0.64|||=|0.705|TWO_SIDED|95.0|0.06|6.43|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -2~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||6.43|0.06|=0.705
73862066|NCT04375397|147270075|SUPERIORITY||Odds Ratio (OR)|0.0|||=|0.996|TWO_SIDED|95.0|0.0||The upper limit of this 95% CI is infinite.||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -1~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"|||0.00|=0.996
73924240|NCT00663052|147377210|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-3.0|||<|0.0001|TWO_SIDED|95.0|-4.4|-1.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-1.7|-4.4|<0.0001
73924241|NCT00663052|147377210|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-3.6|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-2.2|-5.0|<0.0001
73924242|NCT00663052|147377210|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.0|-1.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-1.5|-4.0|<0.0001
73924243|NCT00663052|147377210|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.1||||0.0012|TWO_SIDED|95.0|-3.3|-0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.8|-3.3|0.0012
73924244|NCT00663052|147377210|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.0||||0.0042|TWO_SIDED|95.0|-3.4|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.7|-3.4|0.0042
73924245|NCT00663052|147377211|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 50. Log rank test used to compare groups; CI based on product-limit method.||||<0.0001
73924246|NCT00663052|147377211|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 75. Log rank test used to compare groups; CI based on product-limit method.||||<0.0001
73924247|NCT00663052|147377211|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 90. Log rank test used to compare groups; CI based on product-limit method.||||0.0053
73924248|NCT00663052|147377211|SUPERIORITY_OR_OTHER|||||||0.0432|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 100. Log rank test used to compare groups; CI based on product-limit method.||||0.0432
73924249|NCT00663052|147377212|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74|||Fisher Exact|||Comparison between treatment groups at Week 2||0.74|-0.74|
73924250|NCT00663052|147377212|SUPERIORITY_OR_OTHER||Proportion difference|-0.73||||1|TWO_SIDED|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4||1.44|-2.90|1.0000
74028643|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar color is different.||||0.034
74028644|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar stiffness is different.||||0.041
73862067|NCT04375397|147270075|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 0~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
73862068|NCT04375397|147270075|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 1~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
73862069|NCT04375397|147270075|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 3~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
73924251|NCT00663052|147377212|SUPERIORITY_OR_OTHER||Proportion difference|0.04||||1|TWO_SIDED|95.0|-3.58|3.67|||Fisher Exact|||Comparison between treatment groups at Week 8||3.67|-3.58|1.0000
73924252|NCT00663052|147377212|SUPERIORITY_OR_OTHER||Proportion difference|6.1||||0.0401|TWO_SIDED|95.0|-0.26|12.47|||Fisher Exact|||Comparison between treatment groups at Week 12||12.47|-0.26|0.0401
73924253|NCT00663052|147377212|SUPERIORITY_OR_OTHER||Proportion difference|3.29||||0.4415|TWO_SIDED|95.0|-4.95|11.54|||Fisher Exact|||Comparison between treatment groups at Week 16||11.54|-4.95|0.4415
73924254|NCT00663052|147377212|SUPERIORITY_OR_OTHER||Proportion difference|8.6||||0.0617|TWO_SIDED|95.0|-0.67|17.87|||Fisher Exact|||Comparison between treatment groups at Week 20||17.87|-0.67|0.0617
73924255|NCT00663052|147377212|SUPERIORITY_OR_OTHER||Proportion difference|8.64||||0.072|TWO_SIDED|95.0|-0.96|18.24|||Fisher Exact|||Comparison between treatment groups at Week 24||18.24|-0.96|0.0720
73862070|NCT04375397|147270076|SUPERIORITY||Difference in Medians|-1.5|||=|0.801|TWO_SIDED||||||Van Elteren's test||Ibrutinib 420 mg + SOC - Placebo + SOC|Median days spent on supplemental oxygen was compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.801
73968244|NCT00450658|147474489|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.5||||0.0018|TWO_SIDED|95.0|3.0|15.9|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjects developing UGI (gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative proportion of subjects developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||15.9|3.0|0.0018
73968245|NCT00450658|147474490|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|8.2||||0.0051|TWO_SIDED|95.0|1.9|14.4|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.||||14.4|1.9|0.0051
74028645|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar thickness is different.||||0.23
73924256|NCT00663052|147377213|SUPERIORITY_OR_OTHER||Proportion difference|-1.45||||0.6223|TWO_SIDED|95.0|-5.07|2.16|||Fisher Exact|||Comparison between treatment groups at Week 2||2.16|-5.07|0.6223
73924257|NCT00663052|147377213|SUPERIORITY_OR_OTHER||Proportion difference|6.21||||0.1|TWO_SIDED|95.0|-1.56|13.98|||Fisher Exact|||Comparison between treatment groups at Week 4||13.98|-1.56|0.1000
73924258|NCT00663052|147377213|SUPERIORITY_OR_OTHER||Proportion difference|15.59||||0.0037|TWO_SIDED|95.0|4.53|26.65|||Fisher Exact|||Comparison between treatment groups at Week 8||26.65|4.53|0.0037
73924259|NCT00663052|147377213|SUPERIORITY_OR_OTHER||Proportion difference|22.04||||0.0004|TWO_SIDED|95.0|9.75|34.33|||Fisher Exact|||Comparison between treatment groups at Week 12||34.33|9.75|0.0004
73924260|NCT00663052|147377213|SUPERIORITY_OR_OTHER||Proportion difference|13.46||||0.0285|TWO_SIDED|95.0|0.94|25.97|||Fisher Exact|||Comparison between treatment groups at Week 16||25.97|0.94|0.0285
74028646|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar more irregular.||||0.13
74028647|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: overall opinion.||||0.11
73924261|NCT00663052|147377213|SUPERIORITY_OR_OTHER||Proportion difference|15.05||||0.0139|TWO_SIDED|95.0|2.67|27.43|||Fisher Exact|||Comparison between treatment groups at Week 20||27.43|2.67|0.0139
73924262|NCT00663052|147377213|SUPERIORITY_OR_OTHER||Proportion difference|19.56||||0.0012|TWO_SIDED|95.0|7.38|31.74|||Fisher Exact|||Comparison between treatment groups at Week 24||31.74|7.38|0.0012
73924263|NCT00663052|147377214|SUPERIORITY_OR_OTHER||Proportion difference|5.01||||0.3956|TWO_SIDED|95.0|-6.01|16.03|||Fisher Exact|||Comparison between treatment groups at Week 2||16.03|-6.01|0.3956
73924264|NCT00663052|147377214|SUPERIORITY_OR_OTHER||Proportion difference|8.66||||0.1754|TWO_SIDED|95.0|-3.82|21.14|||Fisher Exact|||Comparison between treatment groups at Week 4||21.14|-3.82|0.1754
73924265|NCT00663052|147377214|SUPERIORITY_OR_OTHER||Proportion difference|13.81||||0.0207|TWO_SIDED|95.0|1.9|25.72|||Fisher Exact|||Comparison between treatment groups at Week 8||25.72|1.90|0.0207
73924266|NCT00663052|147377214|SUPERIORITY_OR_OTHER||Proportion difference|19.38|||<|0.0001|TWO_SIDED|95.0|9.23|29.53|||Fisher Exact|||Comparison between treatment groups at Week 12||29.53|9.23|<0.0001
73924267|NCT00663052|147377214|SUPERIORITY_OR_OTHER||Proportion difference|13.54||||0.0044|TWO_SIDED|95.0|3.79|23.29|||Fisher Exact|||Comparison between treatment groups at Week 16||23.29|3.79|0.0044
73924268|NCT00663052|147377214|SUPERIORITY_OR_OTHER||Proportion difference|10.62||||0.0223|TWO_SIDED|95.0|1.11|20.13|||Fisher Exact|||Comparison between treatment groups at Week 20||20.13|1.11|0.0223
73924269|NCT00663052|147377214|SUPERIORITY_OR_OTHER||Proportion difference|11.37||||0.0133|TWO_SIDED|95.0|1.96|20.78|||Fisher Exact|||Comparison between treatment groups at Week 24||20.78|1.96|0.0133
74028648|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: vascularity.||||0.68
73862071|NCT04375397|147270077|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|80.0|-6.7|7.3|||Miettinen-Nurminen|||"At Day 7-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||7.3|-6.7|=1.000
73924270|NCT00663052|147377215|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear (0,1). Log rank test used to compare groups; CI based on product-limit method.||||0.0003
73924271|NCT00663052|147377215|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear/Mild (0,1,2). Log rank test used to compare groups; CI based on product-limit method.||||0.0022
73924272|NCT00663052|147377216|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0193|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||-0.0|-0.3|0.0193
73924273|NCT00663052|147377216|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0114|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.4|0.0114
73924274|NCT00663052|147377216|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0006|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.5|0.0006
73968246|NCT00450658|147474491|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.9||||0.0017|TWO_SIDED|95.0|0.8|7.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||The secondary efficacy endpoint was the proportion of subjects developing duodenal ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative proportion of subjects developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||7.1|0.8|0.0017
73968247|NCT05071807|147474532|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-1.17|1.33|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and BMI (kg/m2)||To detect a 1.2 percentage point (standard deviation 2.4; effect size 0.5) between-group difference in the change in FMD with 80% power (α=0.05), it was estimated that a sample size of 128 participants was needed (64 per group)||1.33|-1.17|
73968248|NCT05071807|147474533|SUPERIORITY||Mean Difference (Net)|-7.2|||||TWO_SIDED|95.0|-12.3|-2.1|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-2.1|-12.3|
73968249|NCT05071807|147474534|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-0.8|2.9|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||2.9|-0.8|
74028649|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pigmentation.||||0.18
74028650|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: thickness||||0.75
73968250|NCT05071807|147474535|SUPERIORITY||Mean Difference (Net)|-16.4|||||TWO_SIDED|95.0|-30.0|-2.9|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-2.9|-30.0|
73924275|NCT00663052|147377216|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.3|-0.7|<0.0001
73924276|NCT00663052|147377216|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0058|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.1|-0.5|0.0058
73924277|NCT00663052|147377216|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0018|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.1|-0.6|0.0018
74028651|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: relief.||||0.36
73924278|NCT00663052|147377216|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0009|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.2|-0.6|0.0009
73924279|NCT00663052|147377217|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.6396|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.2|-0.3|0.6396
73924280|NCT00663052|147377217|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0074|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.7|0.0074
73924281|NCT00663052|147377217|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0007|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.9|0.0007
74028652|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pliability.||||0.78
74028653|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: surface area.||||0.76
74028654|NCT01753518|147611061|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: overall opinion.||||0.97
73924282|NCT00663052|147377217|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.5|-1.1|<0.0001
73924283|NCT00663052|147377217|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5||||0.004|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.1|-0.8|0.0040
73924284|NCT00663052|147377217|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0004|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.3|-0.9|0.0004
73924285|NCT00663052|147377217|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.1799|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.1|-0.5|0.1799
73924286|NCT00663052|147377218|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.7757|TWO_SIDED|95.0|-0.2|0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.3|-0.2|0.7757
73924287|NCT00663052|147377218|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.2112|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||0.1|-0.4|0.2112
73924288|NCT00663052|147377218|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.5467|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||0.2|-0.3|0.5467
73924289|NCT00663052|147377218|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.3684|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.1|-0.4|0.3684
73924290|NCT00663052|147377218|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||-0.2046|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||0.1|-0.4|-0.2046
73924291|NCT00663052|147377218|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0649|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||0.0|-0.5|0.0649
73924292|NCT00663052|147377218|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.8683|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.2|-0.3|0.8683
73924293|NCT00663052|147377219|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.8898|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.2|-0.3|0.8898
73924294|NCT00663052|147377219|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.009|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.7|0.0090
73968251|NCT05071807|147474536|SUPERIORITY||Mean Difference (Net)|-75.3|||||TWO_SIDED|95.0|-144.0|-6.93|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Total LDL particle mean difference||-6.93|-144|
73924295|NCT00663052|147377219|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0028|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.7|0.0028
73924296|NCT00663052|147377219|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.3|-0.9|0.0001
73968252|NCT05071807|147474536|SUPERIORITY||Mean Difference (Net)|-27.9|||||TWO_SIDED|95.0|-69.3|13.4|||Regression, Linear|adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)||For Large LDL particle subclass||13.4|-69.3|
73968253|NCT05071807|147474537|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.56|0.75|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||Results for total HDL particle count||0.75|-0.56|
73968254|NCT05071807|147474537|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.75|0.8||||Adjusted for baseline value, age, sex, and BMI||Results for Small HDL particles||0.80|-0.75|
73924297|NCT00663052|147377219|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.3|-0.9|<0.0001
73924298|NCT00663052|147377219|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5||||0.0016|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.2|-0.8|0.0016
73924299|NCT00663052|147377219|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0602|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.0|-0.6|0.0602
73968255|NCT05071807|147474537|SUPERIORITY||Mean Difference (Net)|-0.33|||||TWO_SIDED|95.0|-0.85|0.19|||Regression, Linear|Adjusted for baseline value, age, sex, and BMI||Results for Medium HDL||0.19|-0.85|
74028655|NCT01214434|147611062|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
73924300|NCT00663052|147377222|SUPERIORITY_OR_OTHER||Proportion difference|0.42||||1|TWO_SIDED|95.0|-7.7|8.55|||Fisher Exact|||Comparison between treatment groups at Week 12||8.55|-7.70|1.0000
73924301|NCT00663052|147377222|SUPERIORITY_OR_OTHER||Proportion difference|3.94||||0.4213|TWO_SIDED|95.0|-5.75|13.63|||Fisher Exact|||Comparison between treatment groups at Week 16||13.63|-5.75|0.4213
73924302|NCT00663052|147377222|SUPERIORITY_OR_OTHER||Proportion difference|3.98||||0.4039|TWO_SIDED|95.0|-5.38|13.35|||Fisher Exact|||Comparison between treatment groups at Week 20||13.35|-5.38|0.4039
73924303|NCT00663052|147377222|SUPERIORITY_OR_OTHER||Proportion difference|2.5||||0.6168|TWO_SIDED|95.0|-6.87|11.88|||Fisher Exact|||Comparison between treatment groups at Week 24||11.88|-6.87|0.6168
73924304|NCT00663052|147377223|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.862|TWO_SIDED|95.0|-2.8|2.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||||2.3|-2.8|0.8620
73924305|NCT00663052|147377224|SUPERIORITY_OR_OTHER||Proportion difference|5.68||||0.3525|TWO_SIDED|95.0|-6.05|17.4|||Fisher Exact|||Comparison between treatment groups at Week 2||17.40|-6.05|0.3525
73924306|NCT00663052|147377224|SUPERIORITY_OR_OTHER||Proportion difference|14.7||||0.0202|TWO_SIDED|95.0|2.19|27.2|||Fisher Exact|||Comparison between treatment groups at Week 4||27.20|2.19|0.0202
73924307|NCT00663052|147377224|SUPERIORITY_OR_OTHER||Proportion difference|14.41||||0.0178|TWO_SIDED|95.0|2.17|26.64|||Fisher Exact|||Comparison between treatment groups at Week 8||26.64|2.17|0.0178
73924308|NCT00663052|147377224|SUPERIORITY_OR_OTHER||Proportion difference|21.52|||<|0.0001|TWO_SIDED|95.0|11.02|32.03|||Fisher Exact|||Comparison between treatment groups at Week 12||32.03|11.02|<0.0001
73924309|NCT00663052|147377224|SUPERIORITY_OR_OTHER||Proportion difference|10.53||||0.0325|TWO_SIDED|95.0|0.43|20.64|||Fisher Exact|||Comparison between treatment groups at Week 16||20.64|0.43|0.0325
73924310|NCT00663052|147377224|SUPERIORITY_OR_OTHER||Proportion difference|12.04||||0.0129|TWO_SIDED|95.0|2.1|21.97|||Fisher Exact|||Comparison between treatment groups at Week 20||21.97|2.10|0.0129
73968256|NCT05071807|147474538|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-3.09|3.13|||Regression, Linear|were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Results from brachial systolic blood pressure are reported below||3.13|-3.09|
73968257|NCT05071807|147474538|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.67|2.07|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for Brachial Diastolic Blood pressure||2.07|-1.67|
74028656|NCT01214434|147611064|SUPERIORITY_OR_OTHER||||||=|0.03||95.0|||||t-test, 2 sided|||||||=0.03
73924311|NCT00663052|147377224|SUPERIORITY_OR_OTHER||Proportion difference|11.28||||0.0209|TWO_SIDED|95.0|1.26|21.3|||Fisher Exact|||Comparison between treatment groups at Week 24||21.30|1.26|0.0209
73924312|NCT00663052|147377225|SUPERIORITY_OR_OTHER||Proportion difference|12.1||||0.0461|TWO_SIDED|95.0|-0.24|24.44|||Fisher Exact|||Comparison between treatment groups at Week 2||24.44|-0.24|0.0461
73924313|NCT00663052|147377225|SUPERIORITY_OR_OTHER||Proportion difference|8.83||||0.1314|TWO_SIDED|95.0|-2.44|20.1|||Fisher Exact|||Comparison between treatment groups at Week 4||20.10|-2.44|0.1314
73968258|NCT05071807|147474539|SUPERIORITY||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-3.24|2.28|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for central systolic blood pressure||2.28|-3.24|
73924314|NCT00663052|147377225|SUPERIORITY_OR_OTHER||Proportion difference|11.2||||0.0289|TWO_SIDED|95.0|0.65|21.74|||Fisher Exact|||Comparison between treatment groups at Week 8||21.74|0.65|0.0289
73924315|NCT00663052|147377225|SUPERIORITY_OR_OTHER||Proportion difference|8.52||||0.0433|TWO_SIDED|95.0|-0.04|17.07|||Fisher Exact|||Comparison between treatment groups at Week 12||17.07|-0.04|0.0433
73924316|NCT00663052|147377225|SUPERIORITY_OR_OTHER||Proportion difference|7.06||||0.0902|TWO_SIDED|95.0|-1.32|15.43|||Fisher Exact|||Comparison between treatment groups at Week 16||15.43|-1.32|0.0902
73924317|NCT00663052|147377225|SUPERIORITY_OR_OTHER||Proportion difference|7.79||||0.063|TWO_SIDED|95.0|-0.68|16.26|||Fisher Exact|||Comparison between treatment groups at Week 20||16.26|-0.68|0.0630
73924318|NCT00663052|147377225|SUPERIORITY_OR_OTHER||Proportion difference|7.7||||0.0907|TWO_SIDED|95.0|-1.53|16.93|||Fisher Exact|||Comparison between treatment groups at Week 24||16.93|-1.53|0.0907
73924319|NCT00663052|147377228|SUPERIORITY_OR_OTHER||Proportion difference|3.25||||0.6255|TWO_SIDED|95.0|-9.39|15.9|||Fisher Exact|||Comparison between treatment groups at Week 2||15.90|-9.39|0.6255
73924320|NCT00663052|147377228|SUPERIORITY_OR_OTHER||Proportion difference|9.3||||0.1292|TWO_SIDED|95.0|-2.85|21.45|||Fisher Exact|||Comparison between treatment groups at Week 4||21.45|-2.85|0.1292
73924321|NCT00663052|147377228|SUPERIORITY_OR_OTHER||Proportion difference|11.86||||0.0251|TWO_SIDED|95.0|0.94|22.78|||Fisher Exact|||Comparison between treatment groups at Week 8||22.78|0.94|0.0251
73924322|NCT00663052|147377228|SUPERIORITY_OR_OTHER||Proportion difference|14.16||||0.0055|TWO_SIDED|95.0|3.68|24.64|||Fisher Exact|||Comparison between treatment groups at Week 12||24.64|3.68|0.0055
73924323|NCT00663052|147377228|SUPERIORITY_OR_OTHER||Proportion difference|11.99||||0.0159|TWO_SIDED|95.0|1.78|22.2|||Fisher Exact|||Comparison between treatment groups at Week 16||22.20|1.78|0.0159
73924324|NCT00663052|147377228|SUPERIORITY_OR_OTHER||Proportion difference|9.05||||0.0672|TWO_SIDED|95.0|-1.08|19.18|||Fisher Exact|||Comparison between treatment groups at Week 20||19.18|-1.08|0.0672
73924325|NCT00663052|147377228|SUPERIORITY_OR_OTHER||Proportion difference|10.51||||0.0351|TWO_SIDED|95.0|0.27|20.75|||Fisher Exact|||Comparison between treatment groups at Week 24||20.75|0.27|0.0351
73924326|NCT00663052|147377229|SUPERIORITY_OR_OTHER||Proportion difference|6.24||||0.2283|TWO_SIDED|95.0|-4.11|16.58|||Fisher Exact|||Comparison between treatment groups at Week 2||16.58|-4.11|0.2283
73924327|NCT00663052|147377229|SUPERIORITY_OR_OTHER||Proportion difference|5.49||||0.2326|TWO_SIDED|95.0|-3.68|14.66|||Fisher Exact|||Comparison between treatment groups at Week 4||14.66|-3.68|0.2326
73924328|NCT00663052|147377229|SUPERIORITY_OR_OTHER||Proportion difference|10.0||||0.0165|TWO_SIDED|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 8||18.52|1.47|0.0165
74028657|NCT01214434|147611065|SUPERIORITY_OR_OTHER||||||=|0.6||95.0|||||t-test, 2 sided|||||||=0.6
74028658|NCT01214434|147611066|SUPERIORITY_OR_OTHER||||||=|0.24||95.0|||||t-test, 2 sided|||||||=.24
74028659|NCT01214434|147611067|SUPERIORITY_OR_OTHER||||||=|0.8||95.0|||||t-test, 2 sided|||||||=0.8
73924329|NCT00663052|147377229|SUPERIORITY_OR_OTHER||Proportion difference|10.0||||0.0165|TWO_SIDED|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 12||18.52|1.47|0.0165
73924330|NCT00663052|147377229|SUPERIORITY_OR_OTHER||Proportion difference|4.85||||0.2536|TWO_SIDED|95.0|-3.46|13.15|||Fisher Exact|||Comparison between treatment groups at Week 16||13.15|-3.46|0.2536
73924331|NCT00663052|147377229|SUPERIORITY_OR_OTHER||Proportion difference|5.6||||0.1761|TWO_SIDED|95.0|-2.59|13.78|||Fisher Exact|||Comparison between treatment groups at Week 20||13.78|-2.59|0.1761
73862072|NCT04375397|147270077|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|95.0|-14.4|15.5|||Miettinen-Nurminen|||"At Day 7-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||15.5|-14.4|=1.000
73862073|NCT04375397|147270077|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|80.0|-6.7|7.3|||Miettinen-Nurminen|||"At Day 14-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||7.3|-6.7|=1.000
73862074|NCT04375397|147270077|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|95.0|-14.4|15.5|||Miettinen-Nurminen|||"At Day 14-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||15.5|-14.4|=1.000
73924332|NCT00663052|147377229|SUPERIORITY_OR_OTHER||Proportion difference|4.01||||0.3943|TWO_SIDED|95.0|-5.18|13.2|||Fisher Exact|||Comparison between treatment groups at Week 24||13.20|-5.18|0.3943
73924333|NCT00663052|147377230|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.5748|TWO_SIDED|95.0|-1.5|0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.8|-1.5|0.5748
73924334|NCT00663052|147377230|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.2||||0.0471|TWO_SIDED|95.0|-2.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.0|-2.4|0.0471
73924335|NCT00663052|147377230|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.0||||0.0025|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.7|-3.3|0.0025
73924336|NCT00663052|147377230|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.2||||0.0009|TWO_SIDED|95.0|-3.5|-0.9|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.9|-3.5|0.0009
73924337|NCT00663052|147377230|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.9||||0.0015|TWO_SIDED|95.0|-3.1|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.7|-3.1|0.0015
73924338|NCT00663052|147377230|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.5||||0.0197|TWO_SIDED|95.0|-2.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.2|-2.7|0.0197
73924339|NCT00663052|147377230|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.3||||0.0506|TWO_SIDED|95.0|-2.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.0|-2.6|0.0506
73924340|NCT00663052|147377231|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.04||||0.0435|TWO_SIDED|95.0|0.0|0.09|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.09|0.00|0.0435
73924341|NCT00663052|147377231|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.05||||0.0275|TWO_SIDED|95.0|0.01|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.10|0.01|0.0275
74028660|NCT03503773|147611071|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.2682|TWO_SIDED|95.0|-4.8|1.7|||ANCOVA||There was no formal hypothesis testing conducted in the study. 95% CIs are intended to be descriptive in nature only|The null hypothesis to be tested is that there is no difference in the change in 24 hour mean SBP between treatment and sham control. The Type I error rate for rejecting the null hypothesis will be set at an alpha level of 0.05.||1.7|-4.8|0.2682
73924342|NCT00663052|147377232|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.9473|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.7|-0.7|0.9473
73924343|NCT00663052|147377232|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.8217|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.6|-0.8|0.8217
73924344|NCT00663052|147377233|SUPERIORITY_OR_OTHER||Difference of Adjusted Mean Change|-0.7||||0.0539|TWO_SIDED|95.0|-1.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.0|-1.4|0.0539
73924345|NCT00663052|147377233|SUPERIORITY_OR_OTHER||Difference of Adjusted Mean Change|-0.5||||0.1494|TWO_SIDED|95.0|-1.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.2|-1.3|0.1494
73924346|NCT00663052|147377239|SUPERIORITY_OR_OTHER|||||||0.2139|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 12||||0.2139
73924347|NCT00663052|147377239|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 24||||1.0000
74028661|NCT03503773|147611072|SUPERIORITY|||||||0.6964|||||||ANCOVA|||Difference between treatment arms||||0.6964
74028662|NCT03503773|147611073|SUPERIORITY|||||||0.0775|||||||ANCOVA|||Between group difference||||0.0775
73862075|NCT04375397|147270077|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|80.0|-1.7|14.8|||Miettinen-Nurminen|||"At Day 21-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||14.8|-1.7|=0.267
73862076|NCT04375397|147270077|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|95.0|-9.6|22.8|||Miettinen-Nurminen|||"At Day 21-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||22.8|-9.6|=0.267
73862077|NCT04375397|147270077|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|80.0|-1.7|14.8|||Miettinen-Nurminen|||"At Day 28-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||14.8|-1.7|=0.267
73862078|NCT04375397|147270077|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|95.0|-9.6|22.8|||Miettinen-Nurminen|||"At Day 28-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||22.8|-9.6|=0.267
73862079|NCT04375397|147270078|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|80.0|-24.8|3.3|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 7~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||3.3|-24.8|=0.314
73862080|NCT04375397|147270078|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|95.0|-32.8|12.0|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 7~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||12.0|-32.8|=0.314
73862081|NCT04375397|147270078|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|80.0|-24.8|3.3|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 14~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||3.3|-24.8|=0.314
73862082|NCT04375397|147270078|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|95.0|-32.8|12.0|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 14~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||12.0|-32.8|=0.314
73862083|NCT04375397|147270078|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|80.0|-20.4|9.2|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 21~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||9.2|-20.4|=0.599
73862084|NCT04375397|147270078|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|95.0|-28.7|18.1|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 21~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||18.1|-28.7|=0.599
73924348|NCT00663052|147377241|SUPERIORITY_OR_OTHER|||||||0.2443|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 12||||0.2443
73924349|NCT00663052|147377241|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 24||||1.0000
73924350|NCT00663052|147377242|SUPERIORITY_OR_OTHER|||||||0.0807|TWO_SIDED||||||ANCOVA|||Comparison of treatment groups at Week 12||||0.0807
73924351|NCT00663052|147377242|SUPERIORITY_OR_OTHER|||||||0.1454|TWO_SIDED||||||ANCOVA|||Comparison of treatment groups at Week 24||||0.1454
74087102|NCT02310763|147728258|SUPERIORITY||Mean Difference (Net)|-1.5||||0.916|TWO_SIDED|95.0|-30.0|27.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||27.0|-30.0|0.9160
73924352|NCT06002958|147377244|OTHER||Cohen's d|-0.29|||||TWO_SIDED|95.0|-0.815|0.255|||||Inner|||0.255|-0.815|
73924353|NCT06002958|147377244|OTHER||Cohen's d|0.02|||||TWO_SIDED|95.0|-0.503|0.545|||||Outer|||0.545|-0.503|
74028663|NCT03503773|147611075|SUPERIORITY|||||||0.4734|||||||ANCOVA|||Between group difference||||0.4734
74028664|NCT03503773|147611077|SUPERIORITY|||||||0.0341|||||||ANCOVA|||||||0.0341
74028665|NCT03503773|147611079|SUPERIORITY||Mean Difference (Final Values)|-0.029||||0.573|TWO_SIDED|95.0|-0.132|0.073|||Fisher Exact|||||0.073|-0.132|0.573
74028666|NCT00514449|147611121|OTHER||number of voxels in a cluster|2037.0||||0.004|TWO_SIDED|||||p value is adjusted for multiple comparisons|ANCOVA||Time by treatment group interaction term|||||0.004
73924354|NCT06002958|147377244|OTHER||Cohen's d|-0.32|||||TWO_SIDED|95.0|-0.85|0.225|||||Individual|||0.225|-0.850|
73924355|NCT06002958|147377244|OTHER||Cohen's d|0.01|||||TWO_SIDED|95.0|-0.85|0.534|||||Process|||0.534|-0.850|
73924356|NCT00877058|147377250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.05|TWO_SIDED|95.0|0.15|0.48|||Chi-squared|||||0.48|0.15|<0.05
73924357|NCT00877058|147377250|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.001|TWO_SIDED|0.05|0.24|0.68|||Chi-squared|||||0.68|0.24|0.001
73924358|NCT00877058|147377251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56|||<|0.05|TWO_SIDED|95.0|0.96|2.52|||Chi-squared|||||2.52|0.96|<0.05
73924359|NCT00877058|147377251|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||<|0.05|TWO_SIDED|95.0|0.79|2.08|||Chi-squared|||||2.08|0.79|<0.05
73924360|NCT00877058|147377252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||<|0.05|TWO_SIDED|95.0|0.31|0.97|||Chi-squared|||||0.97|0.31|<0.05
73924361|NCT00877058|147377252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||<|0.05|TWO_SIDED|95.0|0.33|1.02|||Chi-squared|||||1.02|0.33|<0.05
73924362|NCT03971695|147377266|OTHER||Adjusted geometric mean (gMean) ratio(%)|100.26|||||TWO_SIDED|90.0|90.18|111.48|||||Intra-individual geometric coefficient of variance (gCV) = 14.2. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||111.48|90.18|
73924363|NCT03971695|147377266|OTHER||Adjusted geometric mean (gMean) ratio(%)|91.63|||||TWO_SIDED|90.0|85.37|98.35|||||Intra-individual geometric coefficient of variance (gCV) = 9.5. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||98.35|85.37|
73924364|NCT03971695|147377267|OTHER||Adjusted geometric mean (gMean) ratio(%)|98.01|||||TWO_SIDED|90.0|84.2|114.08|||||Intra-individual geometric coefficient of variance (gCV) = 20.5. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||114.08|84.20|
73924365|NCT03971695|147377267|OTHER||Adjusted geometric mean (gMean) ratio(%)|77.52|||||TWO_SIDED|90.0|68.11|88.22|||||Intra-individual geometric coefficient of variance (gCV) = 17.4. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||88.22|68.11|
73924366|NCT03971695|147377271|OTHER||Adjusted geometric mean (gMean) ratio(%)|96.42|||||TWO_SIDED|90.0|86.96|106.9|||||Intra-individual geometric coefficient of variance (gCV) = 13.9. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||106.90|86.96|
73924367|NCT03971695|147377271|OTHER||Adjusted geometric mean (gMean) ratio(%)|91.27|||||TWO_SIDED|90.0|85.4|97.54|||||Intra-individual geometric coefficient of variance (gCV) = 8.9. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||97.54|85.40|
73924368|NCT03739112|147377288|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for relative vaccine efficacy (VE) was \> -20%.|percent VE|8.8|||||TWO_SIDED|95.0|-16.7|28.7|||||VE of VLP vaccine versus Fluarix = (1-ARVv/ARVc) x 100% where ARVv = attack rate in participants vaccinated with the Quadrivalent VLP Influenza vaccine and ARVc = attack rate in participants vaccinated with an active Fluarix.|||28.7|-16.7|
73924369|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.14|STANDARD_ERROR_OF_MEAN|0.037||0.1351|TWO_SIDED|95.0|0.96|1.35|||ANOVA|||CREM; Placebo vs GSK256066 1 mcg||1.35|0.96|0.1351
73924370|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.19|STANDARD_ERROR_OF_MEAN|0.037||0.0383|TWO_SIDED|95.0|1.01|1.41|||ANOVA|||CREM; Placebo vs GSK256066 10 mcg||1.41|1.01|0.0383
73924371|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.2|STANDARD_ERROR_OF_MEAN|0.037||0.0325|TWO_SIDED|95.0|1.02|1.43|||ANOVA|||CREM; Placebo vs GSK256066 50 mcg||1.43|1.02|0.0325
73924372|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.42|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|1.2|1.68|||ANOVA|||CREM; Placebo vs GSK256066 200 mcg||1.68|1.20|<0.0001
73924373|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.45|STANDARD_ERROR_OF_MEAN|0.049||0.0015|TWO_SIDED|95.0|1.16|1.82|||ANOVA|||DUSP1; Placebo vs GSK256066 1 mcg||1.82|1.16|0.0015
73924374|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.049||0.0002|TWO_SIDED|95.0|1.24|1.93|||ANOVA|||DUSP1; Placebo vs GSK256066 10 mcg||1.93|1.24|0.0002
73924375|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.74|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.38|2.17|||ANOVA|||DUSP1; Placebo vs GSK256066 50 mcg||2.17|1.38|<0.0001
73924376|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.75|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|1.4|2.18|||ANOVA|||DUSP1; Placebo vs GSK256066 200 mcg||2.18|1.40|<0.0001
73924377|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.49|STANDARD_ERROR_OF_MEAN|0.043||0.0001|TWO_SIDED|95.0|1.22|1.81|||ANOVA|||FOSL2; Placebo vs GSK256066 1 mcg||1.81|1.22|0.0001
73924378|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.52|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.25|1.85|||ANOVA|||FOSL2; Placebo vs GSK256066 10 mcg||1.85|1.25|<0.0001
73924379|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.68|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.38|2.05|||ANOVA|||FOSL2; Placebo vs GSK256066 50 mcg||2.05|1.38|<0.0001
73924380|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.28|1.89|||ANOVA|||FOSL2; Placebo vs GSK256066 200 mcg||1.89|1.28|<0.0001
73924381|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.064||0.0034|TWO_SIDED|95.0|1.16|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 1 mcg||2.07|1.16|0.0034
73924382|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.063||0.0029|TWO_SIDED|95.0|1.17|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 10 mcg||2.07|1.17|0.0029
73924383|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.74|STANDARD_ERROR_OF_MEAN|0.064||0.0003|TWO_SIDED|95.0|1.3|2.33|||ANOVA|||IRS2; Placebo vs GSK256066 50 mcg||2.33|1.30|0.0003
73862085|NCT04375397|147270078|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|80.0|-20.4|9.2|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 28~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||9.2|-20.4|=0.599
73862086|NCT04375397|147270078|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|95.0|-28.7|18.1|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 28~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||18.1|-28.7|=0.599
73862087|NCT04375397|147270079|SUPERIORITY||||||=|0.851|||||||Log Rank|||For the analysis of mechanical ventilation-free survival, the distribution of time to event was estimated by treatment group using Kaplan-Meier methodology and compared between the experimental arm and the control arm using the log-rank test stratified by prescription for remdesivir.||||=0.851
73862088|NCT04375397|147270080|SUPERIORITY||Difference in Medians|0.0|||=|0.745|TWO_SIDED||||||Van Elteren's test||Ibrutinib 420 mg + SOC - Placebo + SOC|Median days spent on mechanical ventilation were compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.745
73862089|NCT04375397|147270081|SUPERIORITY||Difference in Medians|-0.5|||=|0.977|TWO_SIDED||||||Van Elteren's test]||Ibrutinib 420 mg + SOC - Placebo + SOC|Median duration of hospitalization was compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.977
73862090|NCT04375397|147270082|SUPERIORITY||||||=|0.969|||||||Log Rank|||For the analysis of time to discharge from hospital, the distribution of time to event was estimated by treatment group using Kaplan-Meier methodology and compared between the experimental arm and the control arm using the log-rank test stratified by prescription for remdesivir.||||=0.969
73862091|NCT00610441|147270111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6996||||0.0147|TWO_SIDED|97.5|-10.911|-0.4881||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|Mixed Model for Repeated Measurements||Mixed Model for Repeated Measurements (MMRM) with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||-0.4881|-10.911|0.0147
73924384|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.56|STANDARD_ERROR_OF_MEAN|0.063||0.0027|TWO_SIDED|95.0|1.17|2.08|||ANOVA|||IRS2; Placebo vs GSK256066 200 mcg||2.08|1.17|0.0027
73924385|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.54|STANDARD_ERROR_OF_MEAN|0.092||0.0448|TWO_SIDED|95.0|1.01|2.34|||ANOVA|||NR4A2; Placebo vs GSK256066 1 mcg||2.34|1.01|0.0448
73924386|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.87|STANDARD_ERROR_OF_MEAN|0.091||0.0033|TWO_SIDED|95.0|1.24|2.83|||ANOVA|||NR4A2; Placebo vs GSK256066 10 mcg||2.83|1.24|0.0033
73924387|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|2.16|STANDARD_ERROR_OF_MEAN|0.092||0.0004|TWO_SIDED|95.0|1.42|3.3|||ANOVA|||NR4A2; Placebo vs GSK256066 50 mcg||3.30|1.42|0.0004
73924388|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|2.03|STANDARD_ERROR_OF_MEAN|0.091||0.001||95.0|1.34|3.08|||ANOVA|||NR4A2; Placebo vs GSK256066 200 mcg||3.08|1.34|0.0010
73924389|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.03|STANDARD_ERROR_OF_MEAN|0.072||0.8718|TWO_SIDED|95.0|0.74|1.43|||ANOVA|||PDE4A; Placebo vs GSK256066 1 mcg||1.43|0.74|0.8718
73924390|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.18|STANDARD_ERROR_OF_MEAN|0.071||0.3078|TWO_SIDED|95.0|0.86|1.63|||ANOVA|||PDE4A; Placebo vs GSK256066 10 mcg||1.63|0.86|0.3078
73924391|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.19|STANDARD_ERROR_OF_MEAN|0.072||0.2909|TWO_SIDED|95.0|0.86|1.66|||ANOVA|||PDE4A; Placebo vs GSK256066 50 mcg||1.66|0.86|0.2909
73924392|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.38|STANDARD_ERROR_OF_MEAN|0.071||0.0539|TWO_SIDED|95.0|0.99|1.91|||ANOVA|||PDE4A; Placebo vs GSK256066 200 mcg||1.91|0.99|0.0539
73924393|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.06|STANDARD_ERROR_OF_MEAN|0.081||0.7393|TWO_SIDED|95.0|0.74|1.54|||ANOVA|||RGS1; Placebo vs GSK256066 1 mcg||1.54|0.74|0.7393
73924394|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.21|STANDARD_ERROR_OF_MEAN|0.08||0.2967|TWO_SIDED|95.0|0.84|1.74|||ANOVA|||RGS1; Placebo vs GSK256066 10 mcg||1.74|0.84|0.2967
73924395|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.37|STANDARD_ERROR_OF_MEAN|0.081||0.0934|TWO_SIDED|95.0|0.95|1.98|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg||1.98|0.95|0.0934
73924396|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|1.37|STANDARD_ERROR_OF_MEAN|0.08||0.0919|TWO_SIDED|95.0|0.95|1.97|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg||1.97|0.95|0.0919
73924397|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|2.72|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|2.11|3.51|||ANOVA|||SNF1LK; Placebo vs GSK256066 1 mcg||3.51|2.11|<0.0001
73924398|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|3.04|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|2.37|3.9|||ANOVA|||SNF1LK; Placebo vs GSK256066 10 mcg||3.90|2.37|<0.0001
73968259|NCT05071807|147474539|SUPERIORITY||Median Difference (Net)|0.21|||||TWO_SIDED|95.0|-1.69|2.1|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for central diastolic blood pressure||2.10|-1.69|
73924399|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|3.28|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|2.54|4.23|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg||4.23|2.54|<0.0001
73924400|NCT00464568|147377328|SUPERIORITY_OR_OTHER||Treatment Ratios|3.32|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|2.59|4.27|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg||4.27|2.59|<0.0001
73924401|NCT00464568|147377343|SUPERIORITY_OR_OTHER||Mean treatment difference|-0.5545|STANDARD_DEVIATION|7.79598||0.647226|||||||Mixed effects analysis of variance model|||Placebo vs GSK256066 1 mcg: VASP||||0.647226
73968260|NCT05071807|147474540|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.26|0.24|||Regression, Linear|were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||0.24|-0.26|
74028667|NCT00942708|147611128|OTHER|Single group evaluation of change in PVR between 12 weeks and baseline (T-test for one group, 2-sided, p\<0.05 considered significant)||||||0.09|||||||t-test, 1 sided|||||||0.09
74028668|NCT01426386|147611160|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|7.9|||<|0.001|TWO_SIDED|95.0|5.69|10.18||The a priori threshold for statistical significance was 5% (two-sided)|ANCOVA|Number of oocytes retrieved as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||10.18|5.69|<0.001
73862092|NCT00610441|147270111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9926||||0.591|TWO_SIDED|97.5|-3.2961|5.2814||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||5.2814|-3.2961|0.5910
73862093|NCT00610441|147270112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.8506|||||TWO_SIDED|95.0|1.799|26.0878|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||26.0878|1.7990|
73862094|NCT00610441|147270112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9461|||||TWO_SIDED|95.0|0.3119|2.8701|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||2.8701|0.3119|
73862095|NCT00610441|147270113|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.2468|||||TWO_SIDED|95.0|0.6712|58.1395|||||Since no participants in the Placebo group achieved a 50% reduction, the comparison was done using a Cochran-Mantel-Haenszel method and 0.5 was added to both groups.|||58.1395|0.6712|
73862096|NCT00610441|147270113|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1453|||||TWO_SIDED|95.0|0.0152|1.388|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||1.3880|0.0152|
73862097|NCT00610441|147270116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2074|||||TWO_SIDED|95.0|0.5654|2.5785|||||Proportional odds model with fixed effects for treatment and period.|||2.5785|0.5654|
73862098|NCT00610441|147270116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8548|||||TWO_SIDED|95.0|0.6951|4.9494|||||Proportional odds model with fixed effects for treatment and period.|||4.9494|0.6951|
73862099|NCT00610441|147270117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3149|||||TWO_SIDED|95.0|0.5402|3.2008|||||Proportional odds model with fixed effects for treatment and period.|||3.2008|0.5402|
73862100|NCT00610441|147270117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3982|||||TWO_SIDED|95.0|0.524|3.7309|||||Proportional odds model with fixed effects for treatment and period.|||3.7309|0.5240|
73862101|NCT00610441|147270118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3163||||0.6155|TWO_SIDED|97.5|-1.8138|1.1812||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.1812|-1.8138|0.6155
73862102|NCT00610441|147270118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2934||||0.133|TWO_SIDED|97.5|-0.7449|3.3317||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||3.3317|-0.7449|0.1330
73862103|NCT00610441|147270119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5501||||0.3907|TWO_SIDED|97.5|-0.9427|2.0429||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||2.0429|-0.9427|0.3907
73862104|NCT00610441|147270119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0065||||0.9872|TWO_SIDED|97.5|-0.9486|0.9357||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||0.9357|-0.9486|0.9872
73862105|NCT00610441|147270120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1543||||0.7828|TWO_SIDED|97.5|-1.4898|1.1811||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.1811|-1.4898|0.7828
73862106|NCT00610441|147270120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4222||||0.2883|TWO_SIDED|97.5|-0.5187|1.363||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.3630|-0.5187|0.2883
73924402|NCT00464568|147377343|SUPERIORITY_OR_OTHER||Mean treatment difference|-0.3816|STANDARD_DEVIATION|9.00754||0.95084|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: VASP||||0.95084
73924403|NCT00464568|147377343|SUPERIORITY_OR_OTHER||Mean treatment difference|0.0256|STANDARD_DEVIATION|9.24118||0.53499|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 50 mcg: VASP||||0.53499
73862107|NCT00610441|147270121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9685||||0.6532|TWO_SIDED|97.5|-5.9599|4.0229|||MMRM|To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||4.0229|-5.9599|0.6532
73924404|NCT00464568|147377343|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.3371|STANDARD_DEVIATION|7.5459||0.81527|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: VASP||||0.81527
73924405|NCT00464568|147377343|SUPERIORITY_OR_OTHER||Mean treatment difference|-2.8053|STANDARD_DEVIATION|10.88217||0.32998|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 1 mcg: pVASP||||0.32998
73924406|NCT00464568|147377343|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.6602|STANDARD_DEVIATION|12.30724||0.65729|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: pVASP||||0.65729
73924407|NCT00464568|147377343|SUPERIORITY_OR_OTHER||Mean treatment difference|0.156|STANDARD_DEVIATION|4.73976||0.89831|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 50 mcg: pVASP||||0.89831
73924408|NCT00464568|147377343|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.5165|STANDARD_DEVIATION|12.70748||0.84479|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: pVASP||||0.84479
73924409|NCT00930579|147377391|OTHER|This study used two-sided t-tests to compare changes within group- before and after metformin treatment.|Mean Difference (Final Values)|-0.006||||0.98|TWO_SIDED||||||paired t-test|||Null hypothesis: there will be no statistically significant change between the amount of Ki-67 (protein involved in cell proliferation) in participants' tumor cells before and after taking the prescribed dose of Metformin, as measured at the 5% significance level.||||0.98
73924410|NCT00791518|147377430|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||||95.0|0.1|0.4|||||Least squares mean differences are calculated as \<80% group minus \>=80% group and are adjusted for Investigator.|||0.4|0.1|
73924411|NCT00791518|147377431|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||||95.0|0.2|0.4|||||Least squares mean differences are calculated as \<50% group minus \>=50% group and was adjusted for Investigator.|||0.4|0.2|
73924412|NCT00791518|147377436|SUPERIORITY_OR_OTHER||Least squares mean difference|0.7||||||95.0|-0.4|1.7|||||Least squares mean differences are calculated as \<80% group minus \>=80% group and was adjusted for Investigator.|||1.7|-0.4|
73924413|NCT00791518|147377437|SUPERIORITY_OR_OTHER||Least squares mean difference|0.9||||||95.0|-0.2|2.1|||||Least squares mean differences are calculated as \<50% group minus \>=50% group and was adjusted for Investigator.|||2.1|-0.2|
73924414|NCT01520363|147377439|SUPERIORITY||Mean Difference (Net)|-1.182|STANDARD_DEVIATION|4.294||0.211|TWO_SIDED|95.0|-3.086|0.722|||t-test, 2 sided|df=21|||t= -1.291; p=.211|.722|-3.086|.211
73924415|NCT01520363|147377439|SUPERIORITY||Median Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.67||0.949|TWO_SIDED|95.0|-1.345|1.432|||t-test, 2 sided|df=22||||1.432|-1.345|.949
73924416|NCT01520363|147377440|SUPERIORITY||Mean Difference (Final Values)|0.333|STANDARD_DEVIATION|2.456||0.541|TWO_SIDED|95.0|-0.785|1.451||df=20|t-test, 2 sided|df=20|||t=0.622; p=.541|1.451|-0.785|.541
73924417|NCT01520363|147377440|SUPERIORITY||Mean Difference (Net)|-0.042|STANDARD_DEVIATION|2.956||0.946|TWO_SIDED|95.0|-1.29|1.206||df=23|t-test, 2 sided||||t=-.069; p=0.946|1.206|-1.290|.946
73924418|NCT01520363|147377441|SUPERIORITY||Mean Difference (Net)|-0.227|STANDARD_DEVIATION|3.116||0.736|TWO_SIDED|95.0|-1.609|1.154|||t-test, 2 sided|df=21|||t=-0.342; p=0.736|1.154|-1.609|.736
74087103|NCT02310763|147728259|SUPERIORITY||Mean Difference (Net)|0.115||||0.5726|TWO_SIDED|95.0|-0.287|0.517||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 17||0.517|-0.287|0.5726
73924419|NCT01520363|147377441|SUPERIORITY||Mean Difference (Net)|0.409|STANDARD_DEVIATION|3.5||0.589|TWO_SIDED|95.0|-1.143|1.961|||t-test, 2 sided||||t=0.548; p=0.589|1.961|-1.143|.589
73924420|NCT01520363|147377442|SUPERIORITY||Mean Difference (Net)|-1.429|STANDARD_DEVIATION|3.203||0.05|TWO_SIDED|95.0|-2.886|0.029|||t-test, 2 sided|df=20|||t=-2.044; p=0.05|0.029|-2.886|.05
73924421|NCT01520363|147377442|SUPERIORITY||Mean Difference (Net)|0.042|STANDARD_DEVIATION|3.862||0.958|TWO_SIDED|95.0|-1.589|1.672|||t-test, 2 sided||||t=0.053; p=0.958|1.672|-1.589|0.958
73924422|NCT01520363|147377443|SUPERIORITY||Median Difference (Net)|0.227|STANDARD_DEVIATION|1.51||0.488|TWO_SIDED|95.0|-0.442|0.897|||t-test, 2 sided|df=21|||t=0.706; p=0.488|0.897|-0.442|0.488
73924423|NCT01520363|147377443|SUPERIORITY||Median Difference (Net)|0.24|STANDARD_DEVIATION|1.535||0.442|TWO_SIDED|95.0|-0.394|0.874|||t-test, 2 sided|df=24|||t=0.782; p=0.442|0.874|-0.394|0.442
73924424|NCT01520363|147377444|SUPERIORITY||Mean Difference (Net)|0.682|STANDARD_DEVIATION|2.317||0.182|TWO_SIDED|95.0|-0.346|1.709|||t-test, 2 sided|df=21|||t=1.380; p=0.182|1.709|-0.346|0.182
73924425|NCT01520363|147377444|SUPERIORITY||Mean Difference (Net)|1.16|STANDARD_DEVIATION|1.864|<|0.005|TWO_SIDED|95.0|0.391|1.929|||t-test, 2 sided|df=24|||t=3.112; p=0.005|1.929|0.391|<0.005
73924426|NCT01520363|147377445|SUPERIORITY||Mean Difference (Net)|0.091|STANDARD_DEVIATION|3.504||0.9|TWO_SIDED|95.0|-1.463|1.644|||t-test, 2 sided||||t=0.122; p=0.90|1.644|-1.463|0.90
73924427|NCT01520363|147377445|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|2.551||0.356|TWO_SIDED|95.0|-0.573|1.533|||t-test, 2 sided|df=24|||t=0.941; p=0.356|1.533|-0.573|0.356
73924428|NCT01520363|147377446|SUPERIORITY||Mean Difference (Net)|0.136|STANDARD_DEVIATION|3.06||0.836|TWO_SIDED|95.0|-1.22|1.493|||t-test, 2 sided||||t=0.209; p=0.836|1.493|-1.220|0.836
74087104|NCT02310763|147728259|SUPERIORITY||Mean Difference (Net)|-0.163||||0.4334|TWO_SIDED|95.0|-0.574|0.248||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 33||0.248|-0.574|0.4334
73862108|NCT00610441|147270121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1022||||0.5247|TWO_SIDED|97.5|-2.8951|5.0996||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||5.0996|-2.8951|0.5247
73862109|NCT02639338|147270149|SUPERIORITY|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|Binomial Test|||||||<0.001
73924429|NCT01520363|147377446|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_DEVIATION|2.698||0.826|TWO_SIDED|95.0|-0.993|1.233|||t-test, 2 sided|df=24|||t=0.222; p=0.826|1.233|-0.993|0.826
73924430|NCT01520363|147377447|SUPERIORITY||Mean Difference (Net)|-3.38|STANDARD_ERROR_OF_MEAN|4.18||0.42|TWO_SIDED|95.0|-11.8|5.05|||t-test, 2 sided|||||5.05|-11.80|0.42
73924431|NCT01520363|147377448|SUPERIORITY||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|2.97|<|0.73|TWO_SIDED|95.0|-7.02|4.96|||t-test, 2 sided|||||4.96|-7.02|<0.73
73924432|NCT01520363|147377449|SUPERIORITY||Mean Difference (Net)|8.4615|STANDARD_DEVIATION|32.8016||0.371|TWO_SIDED|95.0|-11.3603|28.2834|||t-test, 2 sided|df=12|||t=0.903; p=0.371|28.2834|-11.3603|0.371
73924433|NCT01520363|147377449|SUPERIORITY||Mean Difference (Net)|4.9917|STANDARD_DEVIATION|18.0163||0.358|TWO_SIDED|95.0|-6.4553|16.4387|||t-test, 2 sided|df=11|t=0.960; p=0.358|||16.4387|-6.4553|0.358
73924434|NCT01520363|147377450|SUPERIORITY||Mean Difference (Net)|3.09412|STANDARD_DEVIATION|24.06228||0.603|TWO_SIDED|95.0|-9.27756|15.4658|||t-test, 2 sided|df=16|t=0.530; p=0.603|||15.46580|-9.27756|0.603
73924435|NCT01520363|147377450|SUPERIORITY||Mean Difference (Net)|2.42857|STANDARD_DEVIATION|11.21479||0.432|TWO_SIDED|95.0|-4.04665|8.9038|||t-test, 2 sided|df=13|t=0.810; p=0.432|||8.90380|-4.04665|0.432
73924436|NCT01520363|147377451|SUPERIORITY||Mean Difference (Net)|11.765|STANDARD_DEVIATION|26.276||0.083|TWO_SIDED|95.0|-1.745|25.275|||t-test, 2 sided|df=16|||t=1.846; p=0.083|25.275|-1.745|0.083
73968261|NCT05071807|147474541|SUPERIORITY||Mean Difference (Net)|-1.65|||||TWO_SIDED|95.0|-4.25|0.95|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||0.95|-4.25|
73924437|NCT01520363|147377451|SUPERIORITY||Mean Difference (Net)|7.5|STANDARD_DEVIATION|14.378||0.073|TWO_SIDED|95.0|-0.802|15.802|||t-test, 2 sided|df=13|||t=1.952; p=0.073|15.802|-0.802|0.073
73924438|NCT01520363|147377452|SUPERIORITY||Mean Difference (Net)|3.7474|STANDARD_DEVIATION|26.711||0.549|TWO_SIDED|95.0|-9.1269|16.6217|||t-test, 2 sided|df=18|t=0.612; p=0.549|||16.6217|-9.1269|0.549
73924439|NCT01520363|147377452|SUPERIORITY||Mean Difference (Net)|0.7143|STANDARD_DEVIATION|16.5084||0.874|TWO_SIDED|95.0|-8.8174|10.246|||t-test, 2 sided|df=13|t=0.162; p=0.874|||10.2460|-8.8174|0.874
73924440|NCT01520363|147377453|SUPERIORITY||Mean Difference (Net)|3.8167|STANDARD_DEVIATION|40.2609||0.693|TWO_SIDED|95.0|-16.2046|23.8379|||t-test, 2 sided|df=17|t=0.402; p=0.693|||23.8379|-16.2046|0.693
73924441|NCT01520363|147377453|SUPERIORITY||Mean Difference (Net)|0.84|STANDARD_DEVIATION|27.8994||0.909|TWO_SIDED|95.0|-14.6102|16.2902|||t-test, 2 sided|df=14|t=0.117; p=0.909|||16.2902|-14.6102|0.909
73924442|NCT01520363|147377454|SUPERIORITY||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.64||0.21|TWO_SIDED|95.0|-2.17|0.52|||t-test, 2 sided|||||0.52|-2.17|0.21
73924443|NCT01520363|147377455|SUPERIORITY||Mean Difference (Net)|0.74|STANDARD_ERROR_OF_MEAN|0.68||0.28|TWO_SIDED|95.0|-0.66|2.15|||t-test, 2 sided|||||2.15|-0.66|0.28
73924444|NCT02073279|147377486|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.0184|TWO_SIDED|95.0|0.23|0.89|||Log Rank|||Stratified by prior therapy (B-cell depleting therapy or immunosuppressants/others) and most recent attack (first attack or relapse).||0.89|0.23|0.0184
73924445|NCT02073279|147377487|SUPERIORITY||Mean Difference (Final Values)|3.215|STANDARD_ERROR_OF_MEAN|4.178||0.4436||95.0|-5.086|11.515|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||11.515|-5.086|0.4436
73968262|NCT05071807|147474542|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-0.6|3.0|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||3.0|-0.6|
73924446|NCT02073279|147377488|SUPERIORITY||Mean Difference (Final Values)|2.107|STANDARD_ERROR_OF_MEAN|1.567||0.1824||95.0|-1.008|5.221|||ANCOVA|ANCOVA model included treatment group as fixed effect. Baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||5.221|-1.008|0.1824
73968263|NCT05071807|147474543|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-2.3|1.6|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||1.6|-2.3|
73968264|NCT05071807|147474544|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.1|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||0.1|0.0|
73968265|NCT05071807|147474545|SUPERIORITY||Mean Difference (Net)|9.4|||||TWO_SIDED|95.0|5.0|13.7||When a significant group by time point interaction was detected, post hoc testing was conducted and the Tukey-Kramer method was used to adjust for multiple comparisons.|Mixed Models Analysis|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||13.7|5.0|
73968266|NCT05071807|147474546|SUPERIORITY||Median Difference (Net)|-8.1|||||TWO_SIDED|95.0|-14.5|-1.7|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-1.7|-14.5|
73968267|NCT05071807|147474547|SUPERIORITY||Mean Difference (Net)|-25.5|||||TWO_SIDED|95.0|-98.6|47.5|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Results for medium subclass; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.||47.5|-98.6|
73968268|NCT05071807|147474547|SUPERIORITY||Mean Difference (Net)|1.86|||||TWO_SIDED|95.0|-91.8|95.5|||Regression, Linear|adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)||Results for Small LDL particles; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.||95.5|-91.8|
73924447|NCT01265849|147377526|SUPERIORITY|||||||0.4051||||||For the primary efficacy measure a two-sided p-value of 0.05 or less is considered to be statistically significant in comparing the LI+CIZ+SOC treatment vs. SOC alone for superiority.|Log Rank|Log Rank statistic is based on an unstratified analysis.||The primary objective was to compare overall survival in the LI + CIZ + SOC group to that in the SOC alone group for superiority of the former.||||0.4051
73924448|NCT01265849|147377526|SUPERIORITY|||||||0.5402|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.5402
73924449|NCT01265849|147377526|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.4128|TWO_SIDED|95.0|0.89|1.32|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.32|0.89|0.4128
73924450|NCT01265849|147377526|SUPERIORITY|||||||0.7181|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.7181
73924451|NCT01265849|147377526|SUPERIORITY|||||||0.948|||||||Log Rank|This log Rank p-value is based on a stratified analysis.||||||0.9480
73924452|NCT01265849|147377526|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6101|TWO_SIDED|95.0|0.81|1.42|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A hazard Ratio \< 1.0 would favor LI + SOC.|||1.42|0.81|0.6101
73924453|NCT01265849|147377527|SUPERIORITY|||||||0.0478|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.0478
73924454|NCT01265849|147377527|SUPERIORITY|||||||0.0137|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.0137
73924455|NCT01265849|147377527|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0236|TWO_SIDED|95.0|0.48|0.95|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||0.95|0.48|0.0236
73968269|NCT05071807|147474548|SUPERIORITY||Mean Difference (Net)|0.35|||||TWO_SIDED|95.0|0.07|0.63|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||0.63|0.07|
73924456|NCT01265849|147377527|SUPERIORITY|||||||0.4115|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.4115
73924457|NCT01265849|147377527|SUPERIORITY|||||||0.2862|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.|||This HR is presented as (LI + SOC) / SOC. A HR \< 1.0 favors LI+SOC. Wald p-value for this HR is 0.3859.|||0.2862
73924458|NCT01265849|147377527|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3859|TWO_SIDED|95.0|0.52|1.29|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.29|0.52|0.3859
73968270|NCT01963793|147474550|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.58|TWO_SIDED|95.0|-7.12|4.11|||t-test, 2 sided|||||4.11|-7.12|0.58
74087105|NCT02310763|147728259|SUPERIORITY||Mean Difference (Net)|-0.126||||0.5767|TWO_SIDED|95.0|-0.573|0.321||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 49||0.321|-0.573|0.5767
73924459|NCT01265849|147377528|SUPERIORITY|||||||0.7304||||||P-values are not adjusted for multiple comparisons.|Log Rank|This Log Rank P-value is based on an unstratified analysis.||The secondary endpoint LRC failure is analyzed similar to the primary OS endpoint. The primary comparison is LI+CIZ+SOC vs SOC; LI+SOC vs SOC results are also reported.||||0.7304
73924460|NCT01265849|147377528|SUPERIORITY|||||||0.7171||||||P-values are reported unadjusted for multiplicity.|Log Rank|The Log Rank statistic is based on a stratified analysis.||||||0.7171
73924461|NCT01265849|147377528|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.802|TWO_SIDED|95.0|0.79|1.36|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.36|0.79|0.8020
73924462|NCT01265849|147377528|SUPERIORITY|||||||0.4231|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.4231
73924463|NCT01265849|147377528|SUPERIORITY|||||||0.6998|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.6998
73924464|NCT01265849|147377528|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.3944|TWO_SIDED|95.0|0.81|1.69|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.69|0.81|0.3944
73924465|NCT01265849|147377529|SUPERIORITY|||||||0.6142|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.6142
73924466|NCT01265849|147377529|SUPERIORITY|||||||0.3024|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.3024
73924467|NCT01265849|147377529|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.42082|TWO_SIDED|95.0|0.55|1.28|||Regression, Cox||A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.28|0.55|0.42082
73924468|NCT01265849|147377529|SUPERIORITY|||||||0.9784|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.9784
73924469|NCT01265849|147377529|SUPERIORITY|||||||0.8461||||||This Log Rank statistic is based on a stratified analysis.|Log Rank|||||||0.8461
73924470|NCT01265849|147377529|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.8131|TWO_SIDED|95.0|0.53|1.65|||Regression, Cox||A Hazard Ratio of \< 1.0 would favor LI + SOC.|||1.65|0.53|0.8131
73924471|NCT01265849|147377530|SUPERIORITY|||||||0.3303|||||||Log Rank|This Log Rank statistic is from an unstratified analysis.||This secondary endpoint PFS is analyzed similar to OS and LRC.||||0.3303
73924472|NCT01265849|147377530|SUPERIORITY|||||||0.6669|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.6669
73924473|NCT01265849|147377530|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3728|TWO_SIDED|95.0|0.9|1.31|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.31|0.90|0.3728
73924474|NCT01265849|147377530|SUPERIORITY|||||||0.5739|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.5739
73924475|NCT01265849|147377530|SUPERIORITY|||||||0.8162|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.8162
73924476|NCT01265849|147377530|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.4728|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.43|0.84|0.4728
74028669|NCT01426386|147611161|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|11.1|||<|0.001|TWO_SIDED|95.0|6.78|15.48||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Follicular volume as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||15.48|6.78|<0.001
74028670|NCT01426386|147611162|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|0.8|||<|0.001|TWO_SIDED|95.0|0.56|1.11||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Log(estradiol) as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor, log(dose) and log(baseline estradiol) as covariates||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||1.11|0.56|<0.001
73862110|NCT02639338|147270149|SUPERIORITY|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|2-sided exact 1-sample binomial test|||||||<0.001
73862111|NCT01428336|147270164|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.06|||||TWO_SIDED|95.0|-0.2|0.6||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT||0.60|-0.20|
73862112|NCT01428336|147270164|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.07|||||TWO_SIDED|95.0|-0.69|-0.01||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT||-0.01|-0.69|
73862113|NCT01428336|147270164|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.06|||||TWO_SIDED|95.0|-0.65|0.04||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT||0.04|-0.65|
73862114|NCT01428336|147270165|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.12|||||TWO_SIDED|95.0|-0.24|0.65||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT - free cortisol||0.65|-0.24|
73862115|NCT01428336|147270165|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.18|||||TWO_SIDED|95.0|-0.91|-0.15||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT - free cortisol||-0.15|-0.91|
73862116|NCT01428336|147270165|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.19|||||TWO_SIDED|95.0|-0.94|-0.14||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT - free cortisol||-0.14|-0.94|
73862117|NCT02525094|147270174|SUPERIORITY||Odds Ratio (OR)|1.97|||||TWO_SIDED|95.0|0.9|4.33||||||||4.33|0.90|
73862118|NCT02138240|147270189|OTHER|Pre-post comparison|||||<|0.001|||||||Wilcoxon signed rank sum|||||||<0.001
73862119|NCT02138240|147270192|OTHER|Pre-post comparison of baseline median weight to median weight at 6-month follow up||||||0.21|||||||Wilcoxon signed rank sum|||||||0.21
73862120|NCT01751776|147270197|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.0506|STANDARD_ERROR_OF_MEAN|0.4242|||TWO_SIDED|95.0|1.1843|2.9168|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for Cmax was explored after the first adminstration of BI 65564 on Day 1.||2.9168|1.1843|
74087106|NCT02310763|147728259|SUPERIORITY||Mean Difference (Net)|-0.022||||0.9274|TWO_SIDED|95.0|-0.489|0.446||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 17||0.446|-0.489|0.9274
73862121|NCT01751776|147270197|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.4227|STANDARD_ERROR_OF_MEAN|0.1644|||TWO_SIDED|95.0|1.0869|1.7584|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for Cmax was explored after the last (fourth) adminstration of BI 65564 on Day 22.||1.7584|1.0869|
73862122|NCT01751776|147270198|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.0091|STANDARD_ERROR_OF_MEAN|0.1706|||TWO_SIDED|95.0|1.6607|2.3575|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for AUC 0-infinity was explored after the last adminstration of BI 65564 on Day 22.||2.3575|1.6607|
73862123|NCT01751776|147270199|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.4225|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|95.0|1.0876|1.7574|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for AUCtau was explored after the last administration of BI 65564 on Day 22.||1.7574|1.0876|
73862124|NCT01751776|147270201|OTHER||Mean Difference (Net)|22.7|||||||||||||Mean Difference in percentage|Observed difference of ACR20 response for BI 120mg - Placebo||||
73862125|NCT01751776|147270201|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Mean Difference (Net)|33.0|||||||||||||Mean Difference in percentage|Expected difference of ACR20 response for BI 120mg - Placebo||||
73862126|NCT01751776|147270201|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|99.9||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 0%||||
73968271|NCT01552473|147474572|OTHER|This is a functional Magnetic Resonance Imaging analysis. We aimed to determine whether functional brain network connectivity was equivalent between the two intervention arms prior to the interventions beginning. This was computed in significant numbers of connections between the two groups.|pNBS|0.0001||||0.01|TWO_SIDED|||||This is a p-value that is used in Network Based Statistics analysis for resting-state functional brain network data.|Network Based Statistics analysis|This is a type of statistical analysis used to test for group differences among functional connectivity levels between two or more groups.|This analysis evaluated monotonic changes from time point 1 (pre-intervention) to time points 2 (immediate post-intervention) and 3 (12 weeks post-intervention) that may have occurred between the SMART and BHW groups.|A network-based statistics analysis was carried out to determine brain connectivity differences observed at time points two (initial post-intervention testing phase) and three (the final post-intervention phase) occurring three months post-intervention.||||0.01
73862127|NCT01751776|147270201|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|99.7||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 5%||||
73862128|NCT01751776|147270201|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|98.7||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 10%||||
73862129|NCT01751776|147270201|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|96.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 15%||||
73862130|NCT01751776|147270201|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|90.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 20%||||
73862131|NCT01751776|147270201|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|79.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 25%||||
73862132|NCT01751776|147270201|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|62.5||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 30%||||
73862133|NCT01751776|147270201|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|42.9||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 35%||||
73862134|NCT01751776|147270201|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|24.5||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 40%||||
73862135|NCT01751776|147270201|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|11.1||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 45%||||
73968272|NCT02754882|147474601|EQUIVALENCE|Pre-defined equivalence margin was \[0.737, 1.357\]|Risk Ratio (RR)|1.11|||||TWO_SIDED|90.0|0.975|1.269|||||SB8 vs. Avastin|||1.269|0.975|
73968273|NCT02671903|147474622|SUPERIORITY||Fixed Effect for Treatment|0.25||||0.3|TWO_SIDED|95.0|-0.23|0.73|||Mixed Models Analysis|||Change in treatment effect taken from mixed-model output||0.73|-0.23|0.3
73968274|NCT04258709|147474634|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||.1200
73862136|NCT01751776|147270202|SUPERIORITY_OR_OTHER_LEGACY||Risk difference, unadjusted|18.2||||0.0754|TWO_SIDED|95.0|-6.6|38.6|||One-sided exact test (see description)|One-sided exact test for superiority testing|The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||38.6|-6.6|0.0754
73924477|NCT01265849|147377531|SUPERIORITY|||||||0.1797|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.1797
73924478|NCT01265849|147377531|SUPERIORITY|||||||0.0159|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.0159
73862137|NCT01751776|147270202|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|20.0|||||TWO_SIDED|95.0|-4.6|39.0|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-Tumour Necrosis Factor (TNF)|adjusted||39.0|-4.6|
73924479|NCT01265849|147377531|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0896|TWO_SIDED|95.0|0.55|1.04|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio of \< 1.0 would favor LI + CIZ + SOC.|||1.04|0.55|0.0896
73924480|NCT01265849|147377531|SUPERIORITY|||||||0.5175|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.5175
73924481|NCT01265849|147377531|SUPERIORITY|||||||0.453|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.4530
73924482|NCT01265849|147377531|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4376|TWO_SIDED|95.0|0.54|1.3|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.30|0.54|0.4376
73924483|NCT01265849|147377532|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|2.395||0.21|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|Approximately 30% of participants completed the QOL instrument at first administration (Month2), thus the study did not have the power for QoL comparisons. These completer analyses are descriptive only.||||0.2100
73924484|NCT01265849|147377532|SUPERIORITY||Mean Difference (Net)|4.67|STANDARD_ERROR_OF_MEAN|3.401||0.1701|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + SOC.|Approximately 30% of participants completed the QOL instrument at last administration (Month 36), thus the study did not have power for QoL comparisons. These completer analyses are descriptive only.||||0.1701
73924485|NCT01265849|147377533|SUPERIORITY|This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Median Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.397||0.5871|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|LI + CIZ + SOC, Standard of Care (SOC)||||0.5871
73924486|NCT01265849|147377533|SUPERIORITY||Mean Difference (Net)|4.46|STANDARD_ERROR_OF_MEAN|3.247||0.17|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.1700
73968275|NCT04258709|147474634|SUPERIORITY||Odds Ratio (OR)|0.593||||0.0474|TWO_SIDED|95.0|0.352|0.9907|||Regression, Logistic||Adjusted for race, Iowa Infant Feeding Attitudes Score at baseline, infant gestational age, NICU admission, maternal age at enrollment, WIC enrollment at baseline, maternal pre-pregnancy BMI. This is an adjusted odds ratio.|||.9907|.352|.0474
73968276|NCT04258709|147474635|SUPERIORITY|||||||0.5201|||||||t-test, 1 sided|||||||.5201
73968277|NCT04258709|147474635|SUPERIORITY||Slope|0.1399||||0.9178|TWO_SIDED|95.0|-2.5299|2.8098|||Regression, Linear|||||2.8098|-2.5299|.9178
73968278|NCT04258709|147474636|SUPERIORITY|||||||0.8614|||||||t-test, 1 sided|||||||.8614
73968279|NCT04258709|147474636|SUPERIORITY||Odds Ratio (OR)|1.0763||||0.7836|TWO_SIDED|95.0|0.6364|1.8216|||Regression, Logistic|||||1.8216|.6364|.7836
74087107|NCT02310763|147728259|SUPERIORITY||Mean Difference (Net)|-0.439||||0.0469|TWO_SIDED|95.0|-0.872|-0.006||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 33||-0.006|-0.872|0.0469
73924487|NCT01265849|147377534|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|2.183||0.6296|TWO_SIDED|||||This p-value for head and neck pain at Long Term Follow-up Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.6296
73924488|NCT01265849|147377534|SUPERIORITY||Mean Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|3.103||0.7454|TWO_SIDED|||||This p-value for head and neck pain at Long Term Follow-up Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.7454
73968280|NCT04258709|147474637|SUPERIORITY|||||||0.9788|||||||Chi-squared|||||||.9788
73968281|NCT04258709|147474637|SUPERIORITY||Odds Ratio (OR)|1.0307||||0.9119|TWO_SIDED|95.0|0.603|1.7067|||Regression, Logistic|||||1.7067|.603|.9119
73968282|NCT04258709|147474638|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.2173|TWO_SIDED|95.0|0.4192|1.216|||Regression, Logistic|||||1.216|.4192|.2173
73968283|NCT04258709|147474639|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.5209|TWO_SIDED|95.0|0.4192|1.216|||Regression, Logistic|||||1.216|.4192|.5209
73968284|NCT04258709|147474642|SUPERIORITY|||||||0.4258|||||||Chi-squared|||||||.4258
73968285|NCT04258709|147474642|SUPERIORITY||Odds Ratio (OR)|0.8882||||0.6246|TWO_SIDED|95.0|0.5523|1.4283|||Regression, Logistic|||||1.4283|.5523|.6246
73968286|NCT04258709|147474643|SUPERIORITY|||||||0.5613|||||||Chi-squared|||||||.5613
73968287|NCT04258709|147474643|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.2173|TWO_SIDED|95.0|0.4206|1.2178|||Regression, Logistic|||||1.2178|.4206|.2173
73968288|NCT04258709|147474644|SUPERIORITY|||||||0.6291|||||||Chi-squared|||||||.6291
73968289|NCT04258709|147474644|SUPERIORITY||Odds Ratio (OR)|1.1955||||0.5426|TWO_SIDED|95.0|0.8745|1.3931|||Regression, Logistic|||||1.3931|.8745|.5426
73862138|NCT01751776|147270203|SUPERIORITY_OR_OTHER_LEGACY||risk difference, unadjusted|4.5||||0.3938|TWO_SIDED|95.0|-18.4|22.3|||one-sided exact test (see description)|one-sided exact test for superiority testing.|The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||22.3|-18.4|0.3938
73862139|NCT01751776|147270203|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|4.0|||||TWO_SIDED|95.0|-18.9|21.1|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-TNF history|adjusted||21.1|-18.9|
73862140|NCT01751776|147270206|SUPERIORITY_OR_OTHER_LEGACY||Risk difference|6.8|||||TWO_SIDED|95.0|-17.6|32.7|||||The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||32.7|-17.6|
73862141|NCT01751776|147270206|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|8.9|||||TWO_SIDED|95.0|-15.9|34.2|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-TNF history|adjusted||34.2|-15.9|
73862142|NCT01751776|147270207|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean|-0.14|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|95.0|-0.67|0.39|||||difference calculated as BI 655064 120mg minus placebo. The ANCOVA model was used. In this model the mean was adjusted for region, anti-TNF history and baseline DAS28-CRP.|difference calculated as BI 655064 120mg minus placebo.||0.39|-0.67|
73862143|NCT01122108|147270214|SUPERIORITY_OR_OTHER||||||<|0.05||||||If a sequence was not found to be statistically significant, then that term was removed from final model. Normality of residuals was investigated for each outcome variable using the Shapiro-Wilk test.|repeated measures analysis of variance|Sensitivity analyses were run to evaluate possible product by sequence interactions||"The BASA scale was previously developed to effectively compare differing Bile acid sequestrant forumulations. The BASA scale should differentiate subject acceptability of Colesevelam HCl 3.75 vs Cholestyramine 12g based upon the sum of ratings for taste, texture, appearance and mixability.~If normality hypothesis was rejected, then further inspection of the distribution utilizing normal quantile-quantile and kernel density plots was employed."||||<0.05
73968290|NCT04258709|147474645|SUPERIORITY|||||||0.9071|||||||Chi-squared|||||||.9071
73862144|NCT03159104|147270259|SUPERIORITY||Median Difference (Final Values)|5.0||||0.0113|TWO_SIDED|95.0|1.0|9.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|The difference between final and initial total scholastic skill score was calculated for each participant. Wilcoxon test was used for comparison of these differences because data distribution differs from normal.||9|1|0.0113
73862145|NCT03159104|147270260|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0608|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||5|0|0.0608
73968291|NCT04258709|147474645|SUPERIORITY||Odds Ratio (OR)|1.0233||||0.9328|TWO_SIDED|95.0|0.7751|1.2084|||Regression, Logistic|||||1.2084|.7751|.9328
73862146|NCT03159104|147270261|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0824|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||0|0|0.0824
73862147|NCT03159104|147270262|SUPERIORITY||Median Difference (Final Values)|0.0||||0.2391|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||1|0|0.2391
73862148|NCT03159104|147270263|SUPERIORITY|||||||0.0033|||||||Fisher Exact|||||||0.0033
73862149|NCT03159104|147270264|SUPERIORITY|||||||0.0012|||||||Wilcoxon (Mann-Whitney)|||||||0.0012
73968292|NCT04258709|147474646|SUPERIORITY||Slope|0.8213||||0.5548|TWO_SIDED|95.0|-1.9161|3.5588|||Regression, Linear|||||3.5588|-1.9161|.5548
73968293|NCT04258709|147474647|SUPERIORITY||Slope|1.2412||||0.3861|TWO_SIDED|95.0|-1.5771|4.0594|||Regression, Linear|||||4.0594|-1.5771|.3861
74087108|NCT02310763|147728259|SUPERIORITY||Mean Difference (Net)|-0.166||||0.4362|TWO_SIDED|95.0|-0.587|0.255||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 49||0.255|-0.587|0.4362
73862150|NCT04732949|147270270|OTHER||Hazard Ratio (HR)|1.06||||0.509|TWO_SIDED|95.0|0.89|1.27|||Cox proportional hazard model|||Hazard Ratio for time to hospital discharge - SNG001 vs Placebo||1.27|0.89|0.509
73862151|NCT04732949|147270271|OTHER||Hazard Ratio (HR)|1.02||||0.888|TWO_SIDED|95.0|0.81|1.28|||Cox proportional hazard model|||Hazard Ratio for time to OSCI recovery - SNG001 vs Placebo||1.28|0.81|0.888
73862152|NCT04732949|147270272|OTHER||Odds Ratio (OR)|0.71||||0.161|TWO_SIDED|95.0|0.44|1.15|||Regression, Logistic|||Odds Ratio for progression to severe disease or death - SNG001 vs Placebo||1.15|0.44|0.161
73862153|NCT04732949|147270273|OTHER||Odds Ratio (OR)|0.85||||0.61|TWO_SIDED|95.0|0.45|1.61|||Regression, Logistic|||Odds Ratio for intubation or death - SNG001 vs Placebo||1.61|0.45|0.610
73862154|NCT04732949|147270274|OTHER||Odds Ratio (OR)|0.79||||0.544|TWO_SIDED|95.0|0.38|1.67|||Regression, Logistic|||Odds Ratio for death - SNG001 vs Placebo||1.67|0.38|0.544
73968294|NCT04258709|147474648|SUPERIORITY|||||||0.4779|||||||t-test, 1 sided|||||||.4779
74087109|NCT02310763|147728260|SUPERIORITY||Mean Difference (Net)|-0.156||||0.5557|TWO_SIDED|95.0|-0.679|0.367||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 17||0.367|-0.679|0.5557
73968295|NCT04258709|147474649|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73968296|NCT04258709|147474649|SUPERIORITY||Odds Ratio (OR)|0.9508||||0.9163|TWO_SIDED|95.0|0.3669|2.4621|||Regression, Logistic|||||2.4621|.3669|.9163
73968297|NCT04258709|147474650|SUPERIORITY||Odds Ratio (OR)|1.1084||||0.8031|TWO_SIDED|95.0|0.4937|2.4882|||Regression, Logistic|||||2.4882|.4937|.8031
73968298|NCT04258709|147474651|SUPERIORITY||Odds Ratio (OR)|1.1346||||0.8175|TWO_SIDED|95.0|0.3882|3.3161|||Regression, Logistic|||||3.3161|.3882|.8175
73968299|NCT04258709|147474652|SUPERIORITY||Odds Ratio (OR)|0.6964||||0.434|TWO_SIDED|95.0|0.2813|1.7241|||Regression, Logistic|||||1.7241|.2813|.434
73968300|NCT04258709|147474653|SUPERIORITY||Odds Ratio (OR)|1.2533||||0.4968|TWO_SIDED|95.0|0.6534|2.4041|||Regression, Logistic|||||2.4041|.6534|.4968
73968301|NCT04258709|147474654|SUPERIORITY||Odds Ratio (OR)|1.0288||||0.9005|TWO_SIDED|95.0|0.659|1.6062|||Regression, Logistic|||||1.6062|.659|.9005
73968302|NCT04258709|147474655|SUPERIORITY||Slope|-1.4018||||0.127|TWO_SIDED|95.0|-3.2052|0.4015|||Regression, Linear|||||.4015|-3.2052|.127
74087110|NCT02310763|147728260|SUPERIORITY||Mean Difference (Net)|-0.303||||0.2669|TWO_SIDED|95.0|-0.841|0.235||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 33||0.235|-0.841|0.2669
73924489|NCT01265849|147377534|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|2.465||0.7452|TWO_SIDED|||||This p-value for Long Term Follow-up for swallowing at month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.7452
73924490|NCT01265849|147377534|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|3.496||0.771|TWO_SIDED|||||This p-value for Long Term Follow-up for swallowing at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.7710
73924491|NCT01265849|147377535|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|2.185||0.6337|TWO_SIDED|||||This p-value for Long Term Follow-up for head and neck pain at Month 36 is not adjusted for multiplicity|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.6337
73924492|NCT01265849|147377535|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.962||0.945|TWO_SIDED|||||This p-value for Long Term Follow-up for head and neck pain at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.9450
73924493|NCT01265849|147377535|SUPERIORITY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|2.465||0.4071|TWO_SIDED|||||This p-value for Long Term Follow-up for Swallowing at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI+ CIZ + SOC.|||||0.4071
73924494|NCT01265849|147377535|SUPERIORITY||Mean Difference (Net)|-7.29|STANDARD_ERROR_OF_MEAN|3.347||0.0296|TWO_SIDED|||||This p-value for Long Term Follow-up for Swallowing at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.0296
73924495|NCT01265849|147377536|SUPERIORITY|Statistical tests were for a significant treatment effect in the Cox Proportional Hazards model including treatment, disease stage, tumor location, and geographical region.|% of significant test results|21.6|||<|0.05|TWO_SIDED|95.0|17.0|26.9||"Under the null hypothesis of no effect the expected number of significant test results would be balanced between treatments.~The expected number (%) of statistically significant results would be approximately 14 (5%) of 282."|Regression, Cox|||"Treatment comparisons of LI+CIZ+SOC v. SOC were repeated at all levels of HP, HP ratios, and HP combinations for endpoints OS, PFS, and LRC.~Significant outcomes for the treatment term in the model (two-sided p\<0.05) were accumulated."||26.9|17.0|<0.05
73924496|NCT01265849|147377537|SUPERIORITY||Percent (%) of Participants|8.1|||<|0.0001|TWO_SIDED|95.0|5.6|11.2|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + CIZ + SOC and SOC.||11.2|5.6|<.0001
73924497|NCT01265849|147377537|SUPERIORITY||Percent (%) of Participants|9.7|||<|0.0001|TWO_SIDED|95.0|4.7|14.7|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + SOC and SOC.||14.7|4.7|<0.0001
73924498|NCT01265849|147377538|SUPERIORITY||Percent (%) of Participants|15.2|||<|0.0001|TWO_SIDED|95.0|9.6|20.8|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + CIZ + SOC and SOC.||20.8|9.6|<0.0001
73924499|NCT01265849|147377538|SUPERIORITY||Percent (%) of Participants|18.5|||<|0.0001|TWO_SIDED|95.0|8.2|28.9|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + SOC and SOC.||28.9|8.2|<0.0001
73924500|NCT01265849|147377539|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI + CIZ + SOC.||||0.0007
74087111|NCT02310763|147728260|SUPERIORITY||Mean Difference (Net)|-0.161||||0.4665|TWO_SIDED|95.0|-0.598|0.276||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 49||0.276|-0.598|0.4665
74087112|NCT02310763|147728260|SUPERIORITY||Mean Difference (Net)|-0.083||||0.7335|TWO_SIDED|95.0|-0.564|0.399||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 17||0.399|-0.564|0.7335
73968303|NCT04258709|147474656|SUPERIORITY||Slope|-1.8958||||0.07|TWO_SIDED|95.0|-3.9475|0.1559|||Regression, Linear|||||.1559|-3.9475|.07
74087113|NCT02310763|147728260|SUPERIORITY||Mean Difference (Net)|-0.361||||0.1695|TWO_SIDED|95.0|-0.877|0.156||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 33||0.156|-0.877|0.1695
73924501|NCT01265849|147377539|SUPERIORITY|||||||0.0434|||||||Fisher Exact|||The null hypothesis is that survival is unrelated to objective response versus the alternative that response is predictive of increased survival in subjects receiving LI + SOC.||||0.0434
73924502|NCT01265849|147377539|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The null hypothesis is that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI, considering both treatment groups combined.||||<0.0001
73924503|NCT01265849|147377540|SUPERIORITY|||||||0.0101|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for low risk participants receiving LI + CIZ + SOC.||||0.0101
73968304|NCT04258709|147474657|SUPERIORITY||Slope|-0.506||||0.6299|TWO_SIDED|95.0|-2.574|1.562|||Regression, Linear|||||1.562|-2.574|.6299
73924504|NCT01265849|147377540|SUPERIORITY|||||||0.4843|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for low risk participants receiving LI + SOC.||||0.4843
73924505|NCT01265849|147377540|SUPERIORITY||||||<|0.0067||||||The null hypothesis is that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI, considering both treatment groups combined.|Fisher Exact|||||||<0.0067
73924506|NCT01265849|147377541|SUPERIORITY||Hazard Ratio (HR)|0.348||||0.0131|TWO_SIDED|95.0|0.152|0.801|||Regression, Cox|||Null hypothesis is that the Hazard Ratio (HR) for low risk subjects responding to LI (combined arms LI + CIZ + SOC, LI + SOC) is \>=1.0 versus the alternative hypothesis that subjects responding to LI are at reduced risk of death (HR \< 1.0).||0.801|0.152|0.0131
73924507|NCT01265849|147377541|SUPERIORITY||Hazard Ratio (HR)|0.246||||0.0181|TWO_SIDED|95.0|0.077|0.787|||Regression, Cox|||Null hypothesis is that the Hazard Ratio (HR) for low risk subjects responding to LI + CIZ + SOC is \>=1.0 versus the alternative hypothesis that subjects responding to LI + CIZ + SOC are at reduced risk of death (HR \< 1.0).||0.787|0.077|0.0181
73924508|NCT00003641|147377568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.964|TWO_SIDED||||||Log Rank|stratified on the stratification factors used for randomization||||||0.964
73924509|NCT00003641|147377569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558|TWO_SIDED||||||Log Rank|Stratified on the stratification factors used for randomization||||||0.558
73924510|NCT03886220|147377595|SUPERIORITY||Odds Ratio (OR)|3.22||||0.035|TWO_SIDED|95.0|1.086|9.546||P-value for test of difference between elagolix dose group and placebo is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|Regression, Logistic|||||9.546|1.086|0.035
73924511|NCT00483223|147377622|OTHER|||||||0.54|||||||t-test, 2 sided|||H0: no association between expression ratio and response rate Ha: Participants with expression ratio greater than 2 would have higher response rate||||0.54
73924512|NCT01344161|147377625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.001|TWO_SIDED|95.0|||||ANCOVA|An analysis of covariance (ANCOVA) was used to adjust mean differences on all variables.||||||0.001
73924513|NCT03759379|147377629|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|2.44|<|1e-07|TWO_SIDED|95.0|-21.78|-12.22||P=3.542E-12|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset) and continuous covariate (baseline value).||-12.22|-21.78|<0.0000001
73924514|NCT03759379|147377630|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|-16.2|STANDARD_ERROR_OF_MEAN|2.8|<|1e-07|TWO_SIDED|95.0|-21.7|-10.8||P=5.426E-09|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset baseline NIS) and continuous covariate (baseline value).||-10.8|-21.7|<0.0000001
73924515|NCT03759379|147377631|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|0.131|STANDARD_ERROR_OF_MEAN|0.031|<|1e-07|TWO_SIDED|95.0|0.07|0.193||P=3.103E-05|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset, baseline NIS) and continuous covariate (baseline value).||0.193|0.070|<0.0000001
73924516|NCT02967692|147377658|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.042|TWO_SIDED|95.0|0.655|1.027|||Log Rank|||||1.027|0.655|0.042
73862155|NCT04732949|147270275|OTHER||Odds Ratio (OR)|1.18||||0.323|TWO_SIDED|95.0|0.85|1.64|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 7) - SNG001 vs Placebo||1.64|0.85|0.323
73924517|NCT02967692|147377666|SUPERIORITY||Hazard Ratio (HR)|1.183||||0.2975|TWO_SIDED|95.0|0.865|1.619|||Log Rank|||||1.619|0.865|0.2975
73924518|NCT01536379|147377679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.4|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|95.0|-109.5|40.7||||||||40.7|-109.5|
73924519|NCT01536379|147377700|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|204.35|||||TWO_SIDED|95.0|90.0|550.0|||||Week 24 comparison|||550.00|90.00|
73924520|NCT01536379|147377700|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-33.06|||||TWO_SIDED|95.0|-169.84|25.0|||||Week 52 comparison|||25.00|-169.84|
73924521|NCT01536379|147377701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1232.4|STANDARD_ERROR_OF_MEAN|25735.56|||TWO_SIDED|95.0|-50457.0|52921.8|||||Week 24 comparison|||52921.8|-50457.0|
73924522|NCT01536379|147377701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13128.35|STANDARD_ERROR_OF_MEAN|24165.18|||TWO_SIDED|95.0|-61868.9|35612.2|||||Week 52 comparison|||35612.2|-61868.9|
73924523|NCT01536379|147377702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-31.3|3.7|||||Week 24 comparison|||3.7|-31.3|
73924524|NCT01536379|147377702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|7.68|||TWO_SIDED|95.0|-8.6|22.2|||||Week 52 comparison|||22.2|-8.6|
73924525|NCT01536379|147377703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2791.0|STANDARD_ERROR_OF_MEAN|4651.1|||TWO_SIDED|95.0|-12105.0|6524.0|||||Week 24 comparison|||6524|-12105|
73924526|NCT01536379|147377703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-458.0|STANDARD_ERROR_OF_MEAN|4501.8|||TWO_SIDED|95.0|-9487.0|8572.0|||||Week 52 comparison|||8572|-9487|
73924527|NCT01536379|147377704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|1.156|||TWO_SIDED|95.0|-3.59|1.01|||||Week 24 comparison|||1.01|-3.59|
73924528|NCT01536379|147377704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.017|||TWO_SIDED|95.0|-1.24|2.82|||||Week 52 comparison|||2.82|-1.24|
73924529|NCT01536379|147377705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30326.9|STANDARD_ERROR_OF_MEAN|34677.86|||TWO_SIDED|95.0|-100559.1|39905.3|||||Week 24 comparison|||39905.3|-100559.1|
73924530|NCT01536379|147377705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46955.3|STANDARD_ERROR_OF_MEAN|32594.81|||TWO_SIDED|95.0|-113218.9|19308.3|||||Week 52 comparison|||19308.3|-113218.9|
73924531|NCT01536379|147377706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-10.1|4.2|||||Week 24 comparison|||4.2|-10.1|
73924532|NCT01536379|147377706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|-7.2|6.3|||||Week 52 comparison|||6.3|-7.2|
73924533|NCT01536379|147377707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|648.3|STANDARD_ERROR_OF_MEAN|12618.44|||TWO_SIDED|95.0|-24661.1|25957.7|||||Week 24 comparison|||25957.7|-24661.1|
73924534|NCT01536379|147377707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5618.9|STANDARD_ERROR_OF_MEAN|12153.03|||TWO_SIDED|95.0|-29994.8|18757.0|||||Week 52 comparison|||18757.0|-29994.8|
73924535|NCT01536379|147377708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|-3.2|3.5|||||Week 24 comparison|||3.5|-3.2|
73924536|NCT01536379|147377708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|95.0|-3.5|2.3|||||Week 52 comparison|||2.3|-3.5|
73924537|NCT01536379|147377709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|1.255|||TWO_SIDED|95.0|-4.07|0.98|||||Week 24 comparison|||0.98|-4.07|
73924538|NCT01536379|147377709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.329|||TWO_SIDED|95.0|-3.68|1.67|||||Week 52 comparison|||1.67|-3.68|
73924539|NCT01536379|147377710|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.067|||||TWO_SIDED|95.0|-0.638|0.505|||||Week 24 comparison|||0.505|-0.638|
73968305|NCT04258709|147474658|SUPERIORITY||Odds Ratio (OR)|0.7573||||0.3835|TWO_SIDED|95.0|0.4029|1.4138|||Regression, Logistic|||||1.4138|.4029|.3835
73968306|NCT04258709|147474659|SUPERIORITY||Odds Ratio (OR)|0.784||||0.459|TWO_SIDED|95.0|0.409|1.4912|||Regression, Logistic|||||1.4912|.409|.459
73968307|NCT04258709|147474660|SUPERIORITY||Odds Ratio (OR)|0.9338||||0.8499|TWO_SIDED|95.0|0.458|1.9039|||Regression, Logistic|||||1.9039|.458|.8499
73968308|NCT05521308|147474745|SUPERIORITY||Mean Difference (Final Values)|0.38|||<|0.001|TWO_SIDED|95.0|0.2|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #1, Variation #2 and Same counts.||1.00|0.20|<0.001
74087114|NCT02310763|147728260|SUPERIORITY||Mean Difference (Net)|-0.189||||0.3783|TWO_SIDED|95.0|-0.612|0.234||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 49||0.234|-0.612|0.3783
74087115|NCT02310763|147728261|SUPERIORITY||Mean Difference (Net)|-0.586||||0.1078|TWO_SIDED|95.0|-1.303|0.13||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 17||0.130|-1.303|0.1078
73924540|NCT01536379|147377710|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.267|||||TWO_SIDED|95.0|-0.838|0.305|||||Week 52 comparison|||0.305|-0.838|
73968309|NCT05521308|147474745|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.02|TWO_SIDED|95.0|0.41|6.05|||t-test, 2 sided|||This is to see if there is a difference between Variation #1 and Variation #2 preference counts per participant.||6.05|0.41|0.02
73924541|NCT01536379|147377711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|52.06|||TWO_SIDED|95.0|-105.9|100.3|||||Week 24 comparison|||100.3|-105.9|
73924542|NCT01536379|147377711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|47.52|||TWO_SIDED|95.0|-107.1|81.4|||||Week 52 comparison|||81.4|-107.1|
73924543|NCT01536379|147377712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.92|STANDARD_ERROR_OF_MEAN|9.44|||TWO_SIDED|95.0|-31.56|5.71|||||Week 24 comparison|||5.71|-31.56|
73924544|NCT01536379|147377712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|8.315|||TWO_SIDED|95.0|-19.11|13.72|||||Week 52 comparison|||13.72|-19.11|
73924545|NCT01536379|147377713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.225|||TWO_SIDED|95.0|-4.84|3.96||||||||3.96|-4.84|
73924546|NCT04916600|147377718|SUPERIORITY||Difference in percentages|22.0||||0.043|TWO_SIDED|||||The threshold for statistical significance was p = .05|Chi-squared||Treatment difference = Active device \>=24 hour group - remainder of participants (Active \<24 hr, Sham \>=24 hr, and Sham \<24 hr groups)|||||.043
73924547|NCT04916600|147377719|SUPERIORITY||Mean Difference (Net)|-3.4||||0.032|TWO_SIDED|||||The threshold for statistical significance was p = .05|t-test, 2 sided|df=101||||||.032
73924548|NCT04447417|147377732|OTHER||Point estimate|0.43|||<=|0.0001|TWO_SIDED|90.0|0.37|0.49||One-sided p-value. Threshold for significance at 0.05 level.|linear mixed model||Point estimate obtained was back-transformed by exponentiation|TEWL data for linear mixed model was log-transformed to account for right skewness of data and heteroskedasticity. The linear mixed effect on log (TEWL) included age, sex, number of STS, localization on the body, visit, number of STS-by-visit interaction and number of STS-by-age interaction as fixed effects. Model was run on data on lesional skin area.||0.49|0.37|<=0.0001
73924549|NCT00066066|147377762|SUPERIORITY_OR_OTHER||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.||||>0.05
73924550|NCT00066066|147377762|SUPERIORITY_OR_OTHER||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.||||>0.05
73924551|NCT00066066|147377762|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.||||<0.05
73968310|NCT05521308|147474745|SUPERIORITY||Mean Difference (Final Values)|0.35|||<|0.001|TWO_SIDED|95.0|0.18|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #1, Variation #3 and Same counts.||1.00|0.18|<0.001
73968311|NCT05521308|147474745|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.54|TWO_SIDED|95.0|-1.36|3.55|||t-test, 2 sided|||This is to see if there is a difference between Variation #1 and Variation #3 preference counts per participant.||3.55|-1.36|.54
73924552|NCT00066066|147377762|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.||||<0.05
73924553|NCT00066066|147377762|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.||||<0.05
73924554|NCT00066066|147377762|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.||||>0.05
73924555|NCT00697515|147377902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
73924556|NCT00697515|147377903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||ANOVA|||2.0 hours post-dose||||0.0017
73924557|NCT00697515|147377903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
73924558|NCT00697515|147377903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
73924559|NCT00697515|147377903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
73968312|NCT05521308|147474745|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.231|TWO_SIDED|95.0|0.0|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #2, Variation #3, and Same counts.||1.00|0|.231
73968313|NCT05521308|147474747|SUPERIORITY||Cramer's V|0.14||||0.13|TWO_SIDED||||||Chi-squared|This is to see if there is a difference in preference counts between standard curve, variation #4, and # of times they were rated as the same. -Indoor||||||.13
73968314|NCT05521308|147474747|SUPERIORITY||Cramer's V|0.2||||0.04|TWO_SIDED|||||This is to see if there is a difference in preference counts between standard curve, variation #4, and # of time they were rated as the same. -Outdoor|Chi-squared|||||||0.04
73968315|NCT05521308|147474747|SUPERIORITY||Cramer's V|0.2||||0.04|TWO_SIDED||||||Chi-squared|||The number of participants that showed overall preference toward variation #4 vs. the standard curve vs. no preference. - Outdoors.||||0.04
73968316|NCT05521308|147474748|SUPERIORITY||Effect Size|0.26|||<|0.001|TWO_SIDED|95.0|0.1|1.0|||ANOVA|Initally this is to see if there is a differnce between Unaided, Aided #1 and Aided #2.||Standard Curve vs Variation #4||1.00|0.10|<0.001
73968317|NCT05521308|147474748|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.855|TWO_SIDED|95.0|-2.83|2.35||Post-Hoc Pairwise Comparison|t-test, 2 sided|Standard Curve vs Variation #4||||2.35|-2.83|0.855
73968318|NCT03924986|147474798|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.38|0.73|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|The null hypothesis to be tested is that progression-free survival (PFS) in Arm A is less than or equal to PFS in Arm B. This is compared against the alternative hypothesis, which posits that PFS in Arm A is greater than PFS in Arm B.||0.73|0.38|
74087116|NCT02310763|147728261|SUPERIORITY||Mean Difference (Net)|0.046||||0.8967|TWO_SIDED|95.0|-0.654|0.746||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 33||0.746|-0.654|0.8967
74087117|NCT02310763|147728261|SUPERIORITY||Mean Difference (Net)|-0.378||||0.3196|TWO_SIDED|95.0|-1.128|0.371||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 49||0.371|-1.128|0.3196
73924560|NCT00697515|147377903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
73924561|NCT00697515|147377903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
73924562|NCT00697515|147377904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||Average over the treatment day||||<0.0001
73924563|NCT00697515|147377904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANOVA|||2.0 hours post-dose||||0.0010
73924564|NCT00697515|147377904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
73968319|NCT03924986|147474799|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.11|3.07|||||||Arm B was the reference group, and the odds ratio between arms was calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by gender and liver metastases status.|3.07|1.11|
73968320|NCT03924986|147474801|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.51|1.05|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|||1.05|0.51|
73862156|NCT04732949|147270275|OTHER||Odds Ratio (OR)|1.17||||0.406|TWO_SIDED|95.0|0.81|1.7|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 14) - SNG001 vs Placebo||1.70|0.81|0.406
73924565|NCT00697515|147377904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
73924566|NCT00697515|147377904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
73924567|NCT00697515|147377904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
73924568|NCT00697515|147377904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
73924569|NCT00697515|147377905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||Over the treatment day||||<0.0001
73924570|NCT00697515|147377905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031||95.0|||||ANOVA|||2.0 hours post-dose||||0.0031
73924571|NCT00697515|147377905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
73924572|NCT00697515|147377905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
73924573|NCT00697515|147377905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
73924574|NCT00697515|147377905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
73924575|NCT00697515|147377905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
73924576|NCT00697515|147377906|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73924577|NCT00697515|147377907|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
73924578|NCT00697515|147377910|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Prescott's Test|||||||<0.0001
73924579|NCT00697515|147377911|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73924580|NCT00697515|147377913|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73924581|NCT00697515|147377914|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73924582|NCT03054857|147377933|SUPERIORITY||Risk Ratio (RR)|1.532||||0.289|TWO_SIDED|95.0|0.689|3.406|||Chi-squared|||||3.406|0.689|0.289
73924583|NCT03054857|147377934|SUPERIORITY||Risk Ratio (RR)|1.329||||0.636|TWO_SIDED|95.0|0.409|4.319|||Chi-squared|||||4.319|0.409|0.636
73924584|NCT03054857|147377936|SUPERIORITY||Mean Difference (Final Values)|-1.053|STANDARD_DEVIATION|0.792||0.187|TWO_SIDED|95.0|-2.626|0.52|||t-test, 2 sided|||||0.52|-2.626|0.187
73924585|NCT03054857|147377937|SUPERIORITY||Mean Difference (Final Values)|-4.644|STANDARD_DEVIATION|7.606||0.543|TWO_SIDED|95.0|-19.74|10.45|||t-test, 2 sided|||||10.45|-19.74|0.543
73924586|NCT02603432|147377938|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0005|TWO_SIDED|95.0|0.556|0.863||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model.||||0.863|0.556|0.0005
73924587|NCT02603432|147377961|SUPERIORITY||Cox Proportional Hazard|1.26||||0.913|ONE_SIDED|95.0|0.901||||Log Rank||||||0.901|0.9130
73924588|NCT02666183|147377975|OTHER||Estimated marginal mean difference|-2.251||||0.162|TWO_SIDED|95.0|-5.051|0.55|||ANCOVA|Covariates: DCG age, gender, race, income||||0.550|-5.051|0.162
73924589|NCT02666183|147377975|OTHER||Estimated marginal mean difference|-3.663||||0.007|TWO_SIDED|95.0|-6.538|-0.789|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.789|-6.538|0.007
73924590|NCT02666183|147377975|OTHER||Estimated marginal mean difference|-1.413||||0.714|TWO_SIDED|95.0|-4.29|1.464|||ANCOVA|Covariates: DCG age, gender, race, income||||1.464|-4.290|0.714
73924591|NCT02666183|147377976|OTHER||Estimated marginal mean difference|-0.531||||0.173|TWO_SIDED|95.0|-1.297|0.234|||ANCOVA|Covariates: DCG age, gender, race, income||||0.234|-1.297|0.173
73862157|NCT04732949|147270275|OTHER||Odds Ratio (OR)|0.96||||0.828|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 21) - SNG001 vs Placebo||1.43|0.64|0.828
73924592|NCT02666183|147377976|OTHER||Estimated marginal mean difference|-1.456||||0.001|TWO_SIDED|95.0|-2.241|-0.671|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.671|-2.241|0.001
73924593|NCT02666183|147377976|OTHER||Estimated marginal mean difference|-0.925||||0.021|TWO_SIDED|95.0|-1.711|-0.139|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.139|-1.711|0.021
73924594|NCT02666183|147377977|OTHER||Estimated marginal mean difference|-0.984||||0.323|TWO_SIDED|95.0|-2.939|0.971|||ANCOVA|Covariates: DCG age, gender, race, income||||0.971|-2.939|0.323
73924595|NCT02666183|147377977|OTHER||Estimated marginal mean difference|-1.768||||0.086|TWO_SIDED|95.0|-3.785|0.249|||ANCOVA|Covariates: DCG age, gender, race, income||||0.249|-3.785|0.086
73924596|NCT02666183|147377977|OTHER||Estimated marginal mean difference|-0.784||||0.443|TWO_SIDED|95.0|-2.794|1.226|||ANCOVA|Covariates: DCG age, gender, race, income||||1.226|-2.794|0.443
73924597|NCT05954052|147377979|SUPERIORITY||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|9.0||0.1807|TWO_SIDED|95.0|-6.24|14.24|||Wilcoxon (Mann-Whitney)|||For the analysis of (ABC) scores at baseline and 12 weeks in this single-arm, open-label pilot study (n=6 participants, all with paired data including the early dropout), we use superiority test, This aligns with the study's hypothesis that oral glutathione supplementation would lead to an improvement (i.e., a decrease in ABC scores, indicating reduced irritability). Superiority testing evaluates whether the post-treatment mean (or median) is significantly lower than the baseline||14.24|-6.24|0.1807
73924598|NCT02584504|147377985|SUPERIORITY||Least Square (LS) Mean Difference|-39.5|||<|0.0001|TWO_SIDED|97.5|-46.5|-32.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis|Threshold for significance at 0.025 level.|Alirocumab 150 mg Q4W vs. Placebo|Alirocumab 150 mg Q4W group was compared to placebo group using an appropriate contrast statement.||-32.4|-46.5|<0.0001
73924599|NCT02584504|147377985|SUPERIORITY||LS Mean Difference|-65.8|||<|0.0001|TWO_SIDED|97.5|-72.9|-58.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q2W group was compared to placebo group using an appropriate contrast statement.||-58.7|-72.9|<0.0001
73924600|NCT02584504|147377985|OTHER|Statistical test was not planned because this comparison was for a descriptive purpose.|LS Mean Difference|-26.3|||||TWO_SIDED|95.0|-32.5|-20.0|||||Alirocumab 150 mg Q4W group vs Alirocumab 150 mg Q2W|Alirocumab 150 mg Q4W group was compared to Alirocumab 150 mg Q2W group using an appropriate contrast statement.||-20.0|-32.5|
73924601|NCT02584504|147377986|SUPERIORITY||LS Mean Difference|-40.6|||<|0.0001|TWO_SIDED|97.5|-47.4|-33.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Hierarchical procedure for comparisons of Alirocumab 150 mg Q4W versus Placebo Q2W and Alirocumab 150 mg Q2W versus Placebo Q2W were processed separately.||-33.8|-47.4|<0.0001
73924602|NCT02584504|147377986|SUPERIORITY||LS Mean Difference|-67.4|||<|0.0001|TWO_SIDED|97.5|-74.2|-60.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-60.5|-74.2|<0.0001
73924603|NCT02584504|147377987|SUPERIORITY||LS Mean Difference|-50.5|||<|0.0001|TWO_SIDED|97.5|-56.6|-44.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-44.5|-56.6|<0.0001
73862158|NCT04732949|147270275|OTHER||Odds Ratio (OR)|0.92||||0.706|TWO_SIDED|95.0|0.61|1.4|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 28) - SNG001 vs Placebo||1.40|0.61|0.706
73924604|NCT02584504|147377987|SUPERIORITY||LS Mean Difference|-66.2|||<|0.0001|TWO_SIDED|97.5|-72.3|-60.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-60.1|-72.3|<0.0001
73862159|NCT04732949|147270276|OTHER||Odds Ratio (OR)|1.71||||0.101|TWO_SIDED|95.0|0.9|3.22|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 7) - SNG001 vs Placebo||3.22|0.90|0.101
73862160|NCT04732949|147270276|OTHER||Odds Ratio (OR)|0.99||||0.942|TWO_SIDED|95.0|0.67|1.45|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 14) - SNG001 vs Placebo||1.45|0.67|0.942
74028671|NCT01426386|147611164|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|3.2|||<|0.001|TWO_SIDED|95.0|1.71|4.78||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Fertilised oocytes as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||4.78|1.71|<0.001
74028672|NCT01426386|147611166|OTHER|Treatment groups were compared using the chi-squared test.||||||0.248||||||No adjustment for multiplicity was applied for the secondary endpoints|Chi-squared|||||||0.248
74028673|NCT01096667|147611169|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.97||||0.034|TWO_SIDED|80.0|-5.05|-0.89||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.89|-5.05|0.034
74028674|NCT01096667|147611169|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.0||||0.01|TWO_SIDED|80.0|-6.17|-1.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.82|-6.17|0.010
74028675|NCT01096667|147611169|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.69||||0.012|TWO_SIDED|80.0|-5.78|-1.6||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.60|-5.78|0.012
74028676|NCT01096667|147611169|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.21||||0.024|TWO_SIDED|80.0|-5.3|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.13|-5.30|0.024
73862161|NCT04732949|147270276|OTHER||Odds Ratio (OR)|0.96||||0.824|TWO_SIDED|95.0|0.68|1.35|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 21) - SNG001 vs Placebo||1.35|0.68|0.824
73862162|NCT04732949|147270276|OTHER||Odds Ratio (OR)|0.92||||0.613|TWO_SIDED|95.0|0.66|1.28|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 28) - SNG001 vs Placebo||1.28|0.66|0.613
73862163|NCT04732949|147270278|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.41|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|||SNG001 vs Placebo||0.3|-0.1|0.410
73862164|NCT04271475|147270304|SUPERIORITY||Least square mean|-16.1|STANDARD_ERROR_OF_MEAN|8.2||0.974|TWO_SIDED|95.0|-32.34|0.16|||MMRM||Least square mean and SE of the mean was estimated by mixed model repeated measurements method.|||0.16|-32.34|0.974
74028677|NCT01096667|147611171|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.7||||0.018|TWO_SIDED|80.0|-5.94|-1.46||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.46|-5.94|0.018
74028678|NCT01096667|147611171|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.43||||0.008|TWO_SIDED|80.0|-6.78|-2.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-2.09|-6.78|0.008
74028679|NCT01096667|147611171|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.99||||0.002|TWO_SIDED|80.0|-7.24|-2.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-2.74|-7.24|0.002
74028680|NCT01096667|147611171|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.92||||0.013|TWO_SIDED|80.0|-6.16|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.67|-6.16|0.013
74028681|NCT01096667|147611172|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.19||||0.152|TWO_SIDED|80.0|-4.93|0.54||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.54|-4.93|0.152
74028682|NCT01096667|147611172|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.18||||0.078|TWO_SIDED|80.0|-6.06|-0.3||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.30|-6.06|0.078
74028683|NCT01096667|147611172|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.02||||0.174|TWO_SIDED|80.0|-4.79|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.74|-4.79|0.174
74028684|NCT01096667|147611172|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.01||||0.174|TWO_SIDED|80.0|-4.77|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.74|-4.77|0.174
74028685|NCT01096667|147611174|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.01||||0.047|TWO_SIDED|80.0|-7.09|-0.94||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-0.94|-7.09|0.047
74028686|NCT01096667|147611174|SUPERIORITY_OR_OTHER||Difference in least squares means|-7.16||||0.002|TWO_SIDED|80.0|-10.25|-4.07||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-4.07|-10.25|0.002
74028687|NCT01096667|147611174|SUPERIORITY_OR_OTHER||Difference in least squares means|-6.2||||0.005|TWO_SIDED|80.0|-9.28|-3.11||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-3.11|-9.28|0.005
74028688|NCT01096667|147611174|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.37||||0.033|TWO_SIDED|80.0|-7.41|-1.33||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.33|-7.41|0.033
74028689|NCT01096667|147611176|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.66||||0.007|TWO_SIDED|80.0|-4.03|-1.29||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.29|-4.03|0.007
74028690|NCT01096667|147611176|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.11||||0.003|TWO_SIDED|80.0|-4.55|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.67|-4.55|0.003
74028691|NCT01096667|147611176|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.27||||0.018|TWO_SIDED|80.0|-3.65|-0.88||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-0.88|-3.65|0.018
74087118|NCT02310763|147728261|SUPERIORITY||Mean Difference (Net)|-0.689||||0.0526|TWO_SIDED|95.0|-1.386|0.008||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 17||0.008|-1.386|0.0526
73924605|NCT02584504|147377988|SUPERIORITY||LS Mean Difference|-51.4|||<|0.0001|TWO_SIDED|97.5|-57.4|-45.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-45.4|-57.4|<0.0001
74087119|NCT02310763|147728261|SUPERIORITY||Mean Difference (Net)|-0.336||||0.3739|TWO_SIDED|95.0|-1.082|0.41||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 33||0.410|-1.082|0.3739
74087120|NCT02310763|147728261|SUPERIORITY||Mean Difference (Net)|-0.322||||0.4019|TWO_SIDED|95.0|-1.079|0.436||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 49||0.436|-1.079|0.4019
74087121|NCT02310763|147728262|SUPERIORITY||Mean Difference (Net)|-0.107||||0.7676|TWO_SIDED|95.0|-0.825|0.61||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 17||0.610|-0.825|0.7676
74087122|NCT02310763|147728262|SUPERIORITY||Mean Difference (Net)|-0.322||||0.4127|TWO_SIDED|95.0|-1.098|0.454||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 33||0.454|-1.098|0.4127
74087123|NCT02310763|147728262|SUPERIORITY||Mean Difference (Net)|0.113||||0.7815|TWO_SIDED|95.0|-0.693|0.919||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 49||0.919|-0.693|0.7815
74087124|NCT02310763|147728262|SUPERIORITY||Mean Difference (Net)|-0.236||||0.4975|TWO_SIDED|95.0|-0.924|0.451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 17||0.451|-0.924|0.4975
74087125|NCT02310763|147728262|SUPERIORITY||Mean Difference (Net)|-0.467||||0.2646|TWO_SIDED|95.0|-1.294|0.359||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 33||0.359|-1.294|0.2646
74087126|NCT02310763|147728262|SUPERIORITY||Mean Difference (Net)|-0.149||||0.732|TWO_SIDED|95.0|-1.008|0.71||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 49||0.710|-1.008|0.7320
74087127|NCT02310763|147728263|SUPERIORITY||Mean Difference (Net)|-0.044||||0.8569|TWO_SIDED|95.0|-0.525|0.437||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 17||0.437|-0.525|0.8569
73862165|NCT00159913|147270321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.71|STANDARD_ERROR_OF_MEAN|3.98||0.056||95.0|-0.19|15.6||No adjustments for multiple comparisons have been made.|ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||15.60|-0.19|0.056
73924606|NCT02584504|147377988|SUPERIORITY||LS Mean Difference|-67.3|||<|0.0001|TWO_SIDED|97.5|-73.3|-61.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-61.3|-73.3|<0.0001
74087128|NCT02310763|147728263|SUPERIORITY||Mean Difference (Net)|-0.154||||0.5495|TWO_SIDED|95.0|-0.663|0.355||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 33||0.355|-0.663|0.5495
74087129|NCT02310763|147728263|SUPERIORITY||Mean Difference (Net)|-0.023||||0.934|TWO_SIDED|95.0|-0.566|0.521||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 49||0.521|-0.566|0.9340
74087130|NCT02310763|147728263|SUPERIORITY||Mean Difference (Net)|-0.236||||0.3279|TWO_SIDED|95.0|-0.711|0.239||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 17||0.239|-0.711|0.3279
74087131|NCT02310763|147728263|SUPERIORITY||Mean Difference (Net)|-0.757||||0.0086|TWO_SIDED|95.0|-1.318|-0.196||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 33||-0.196|-1.318|0.0086
74087132|NCT02310763|147728263|SUPERIORITY||Mean Difference (Net)|-0.439||||0.2328|TWO_SIDED|95.0|-1.165|0.286||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 49||0.286|-1.165|0.2328
74087133|NCT02310763|147728264|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.211||||0.8908|TWO_SIDED|95.0|-2.8353|3.2573|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||3.2573|-2.8353|0.8908
73924607|NCT02584504|147377989|SUPERIORITY||LS Mean Difference|-26.2|||<|0.0001|TWO_SIDED|97.5|-32.5|-19.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-19.9|-32.5|<0.0001
74087134|NCT02310763|147728265|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.819||||0.4748|TWO_SIDED|95.0|-1.4514|3.0895|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||3.0895|-1.4514|0.4748
74087135|NCT02310763|147728266|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0097||||0.807|TWO_SIDED|95.0|-0.0692|0.0887|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||0.0887|-0.0692|0.8070
74087136|NCT02310763|147728267|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0506||||0.3643|TWO_SIDED|95.0|-0.0594|0.1607|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||0.1607|-0.0594|0.3643
74087137|NCT02310763|147728268|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-2.9||||0.0483|TWO_SIDED|95.0|-5.7|0.0|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||0|-5.7|0.0483
73924608|NCT02584504|147377989|SUPERIORITY||LS Mean Difference|-51.9|||<|0.0001|TWO_SIDED|97.5|-58.3|-45.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-45.5|-58.3|<0.0001
73924609|NCT02584504|147377990|SUPERIORITY||LS Mean Difference|-27.2|||<|0.0001|TWO_SIDED|97.5|-33.5|-20.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-20.9|-33.5|<0.0001
73924610|NCT02584504|147377990|SUPERIORITY||LS Mean Difference|-53.4|||<|0.0001|TWO_SIDED|97.5|-59.7|-47.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-47.1|-59.7|<0.0001
73924611|NCT02584504|147377991|SUPERIORITY||LS Mean Difference|-31.3|||<|0.0001|TWO_SIDED|97.5|-37.7|-25.0||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-25.0|-37.7|<0.0001
73924612|NCT02584504|147377991|SUPERIORITY||LS Mean Difference|-56.2|||<|0.0001|TWO_SIDED|97.5|-62.5|-49.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-49.8|-62.5|<0.0001
73924613|NCT02584504|147377992|SUPERIORITY||LS Mean Difference|-32.4|||<|0.0001|TWO_SIDED|97.5|-38.6|-26.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-26.3|-38.6|<0.0001
73924614|NCT02584504|147377992|SUPERIORITY||LS Mean Difference|-57.6|||<|0.0001|TWO_SIDED|97.5|-63.8|-51.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-51.4|-63.8|<0.0001
73924615|NCT02584504|147377993|SUPERIORITY||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|97.5|-27.4|-17.6||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-17.6|-27.4|<0.0001
73924616|NCT02584504|147377993|SUPERIORITY||LS Mean Difference|-41.4|||<|0.0001|TWO_SIDED|97.5|-46.4|-36.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-36.5|-46.4|<0.0001
73924617|NCT02584504|147377994|SUPERIORITY||Odds Ratio (OR)|61.2|||<|0.0001|TWO_SIDED|97.5|13.9|268.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||268.9|13.9|<0.0001
73924618|NCT02584504|147377994|SUPERIORITY||Odds Ratio (OR)|281.4|||<|0.0001|TWO_SIDED|97.5|33.3|2382.2||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||2382.2|33.3|<0.0001
73924619|NCT02584504|147377995|SUPERIORITY||Odds Ratio (OR)|102.8|||<|0.0001|TWO_SIDED|97.5|19.0|556.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||556.8|19.0|<0.0001
74028692|NCT01096667|147611176|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.19||||0.021|TWO_SIDED|80.0|-3.56|-0.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-0.82|-3.56|0.021
73862166|NCT00159913|147270321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.81|STANDARD_ERROR_OF_MEAN|5.0||||95.0|-6.11|13.73|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||13.73|-6.11|
73862167|NCT00159913|147270321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.33|STANDARD_ERROR_OF_MEAN|4.84||||95.0|1.72|20.94|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||20.94|1.72|
73924620|NCT02584504|147377995|SUPERIORITY||Odds Ratio (OR)|500.8|||<|0.0001|TWO_SIDED|97.5|47.9|5230.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||5230.9|47.9|<0.0001
73924621|NCT02584504|147377996|SUPERIORITY||Adjusted Mean Difference|-32.9|||<|0.0001|TWO_SIDED|97.5|-43.4|-22.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-22.5|-43.4|<0.0001
73924622|NCT02584504|147377996|SUPERIORITY||Adjusted Mean Difference|-50.9|||<|0.0001|TWO_SIDED|97.5|-61.5|-40.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-40.3|-61.5|<0.0001
74028693|NCT01096667|147611177|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.99||||0.004|TWO_SIDED|80.0|-4.43|-1.55||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.55|-4.43|0.004
73924623|NCT02584504|147377997|SUPERIORITY||LS Mean Difference|5.7||||0.0241|TWO_SIDED|97.5|0.0|11.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||11.3|0.0|0.0241
73924624|NCT02584504|147377997|SUPERIORITY||LS Mean Difference|7.8||||0.0022|TWO_SIDED|97.5|2.1|13.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||13.5|2.1|0.0022
73924625|NCT02584504|147377998|SUPERIORITY||Adjusted Mean Difference|5.9||||0.2645|TWO_SIDED|97.5|-5.9|17.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||17.7|-5.9|0.2645
73924626|NCT02584504|147377998|SUPERIORITY||Adjusted Mean Difference|-11.6||||0.0299|TWO_SIDED|97.5|-23.5|0.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||0.4|-23.5|0.0299
73924627|NCT02066467|147378031|OTHER||||||<|0.0001|||||||exact binominal methodology|||||||<0.0001
73924628|NCT02066467|147378033|OTHER||||||<|0.0001|||||||exact binominal methodology|||||||<0.0001
73924629|NCT00456521|147378034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.21|||<|0.001||95.0|-5.56|-2.86|||ANCOVA|||||-2.86|-5.56|<0.001
73924630|NCT00456521|147378035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.89|||<|0.001||95.0|2.02|4.13|||Regression, Logistic|||||4.13|2.02|<0.001
73924631|NCT00456521|147378036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92|||<|0.001|TWO_SIDED|95.0|1.95|4.37|||Regression, Logistic|||||4.37|1.95|<0.001
73924632|NCT00456521|147378037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.21|||<|0.001|TWO_SIDED|95.0|-4.82|-1.6|||ANCOVA|||||-1.60|-4.82|<0.001
73968321|NCT03924986|147474802|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.38|0.76|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|The null hypothesis to be tested is that progression-free survival (PFS) in Arm A is less than or equal to PFS in Arm B. This is compared against the alternative hypothesis, which posits that PFS in Arm A is greater than PFS in Arm B.||0.76|0.38|
74028694|NCT01096667|147611177|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.75||||0.01|TWO_SIDED|80.0|-4.26|-1.24||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.24|-4.26|0.010
74028695|NCT01096667|147611177|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.64||||0.01|TWO_SIDED|80.0|-4.09|-1.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.19|-4.09|0.010
74028696|NCT01096667|147611177|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.57||||0.011|TWO_SIDED|80.0|-4.0|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.13|-4.00|0.011
74028697|NCT01096667|147611178|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.5||||0.048|TWO_SIDED|80.0|-4.43|-0.57||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.57|-4.43|0.048
74087138|NCT02310763|147728269|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-3.9||||0.0146|TWO_SIDED|95.0|-7.0|-0.8|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||-0.8|-7.0|0.0146
73924633|NCT00456521|147378038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.11||||0.004|TWO_SIDED||||||ANCOVA|||||||0.004
73924634|NCT00456521|147378039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.53||||0.003|TWO_SIDED||||||ANCOVA|||||||0.003
73924635|NCT00456521|147378040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.23|||<|0.001|TWO_SIDED|95.0|1.52|4.95|||ANCOVA|||||4.95|1.52|<0.001
73924636|NCT00456521|147378041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.14||||0.001|TWO_SIDED|95.0|1.23|5.04|||ANCOVA|||||5.04|1.23|0.001
73924637|NCT00456521|147378042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.37||||0.003|TWO_SIDED||||||ANCOVA|||||||0.003
73924638|NCT00456521|147378043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.98||||0.165|TWO_SIDED||||||ANCOVA|||||||0.165
73924639|NCT00456521|147378044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.28|||||TWO_SIDED|95.0|-3.34|0.79||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.79|-3.34|
73924640|NCT00456521|147378045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|||||TWO_SIDED|95.0|-7.26|1.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.86|-7.26|
73924641|NCT00456521|147378046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.55|||||TWO_SIDED|95.0|0.97|4.14||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.14|0.97|
73924642|NCT00456521|147378047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37|||||TWO_SIDED|95.0|0.25|2.49||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.49|0.25|
74028698|NCT01096667|147611178|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.54||||0.013|TWO_SIDED|80.0|-5.58|-1.51||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.51|-5.58|0.013
74028699|NCT01096667|147611178|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.88||||0.111|TWO_SIDED|80.0|-3.82|0.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.09|-3.82|0.111
73862168|NCT00159913|147270321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.98|STANDARD_ERROR_OF_MEAN|4.85||||95.0|-1.64|17.6|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||17.60|-1.64|
73862169|NCT00159913|147270322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.2||0.172||95.0|-7.5|1.3|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||1.3|-7.5|0.172
73862170|NCT00159913|147270322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|3.1||||95.0|-4.5|7.6|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||7.6|-4.5|
73924643|NCT00456521|147378048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.7|0.87||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.87|-0.70|
73924644|NCT00456521|147378049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.85|0.63||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.63|-0.85|
73924645|NCT00456521|147378050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.78|0.6||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.60|-0.78|
73924646|NCT00456521|147378051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.29|||||TWO_SIDED|95.0|-9.16|-1.42||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-1.42|-9.16|
73924647|NCT02596854|147378084|NON_INFERIORITY|α=0.025 with a margin of Δ=0.5 were used for non-inferiority testing|Median Difference (Net)|-0.428|STANDARD_ERROR_OF_MEAN|0.3522|<|0.001|TWO_SIDED|95.0|-0.428|-0.269||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)||Notably, no separate comparative statistical analysis was performed for the 1.5T and 3.0T subgroups, which were pooled for analysis. All patients underwent both synthetic MR and commercial conventional MR in a single arm.|Non-inferiority of synthetic MR versus conventional commercial MR the hypothesis can be stated as H0: S ≤ -Δ and HA: S \> -Δ.|To mitigate possible bias, the hypothesis test was executed via pre-programmed SAS module, which does not show the data for individual synthetic and conventional group values. The data for these individual groups is thus not currently available as part of the study report held by the sponsor or submitted to FDA. Thus, this data cannot be presented without additional analysis (re-programming) of the original SAS used to perform the study. Data were only reported as the difference between synthetic - conventional to determine non-inferiority, and data for individual crossovers (synthetic vs. conventional) were not calculated.The raw conventional scan images and those post-processed with the research software were combined as pre-specified in the study protocol|-0.269|-0.428|<0.001
73924648|NCT03615326|147378150|SUPERIORITY|The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.61|0.87|||Log Rank|One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|PFS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||0.87|0.61|0.0002
73968322|NCT00999804|147474884|SUPERIORITY_OR_OTHER_LEGACY||proportion of pCR|0.25|||||TWO_SIDED||||||||No comparison is required between the 24 weeks arm and 12 weeks arm. The study is designed as the 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design and required 20 or more responses in the first 55 evaluable patients.|"The study was planned to enroll 136 patients if the original cohort (n=90) was deemed successful. The 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design. The 12 weeks arm accrued as long as the 24 weeks arm is open.~The analysis of the first cohort indicated that 15 pCR were observed , which did not meet the required 20 or more responses. The accrual was closed early and the study has a total of 128 participants."||||
74028700|NCT01096667|147611178|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.58||||0.148|TWO_SIDED|80.0|-3.51|0.36||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.36|-3.51|0.148
73862171|NCT00159913|147270322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.7||||95.0|-8.9|1.9|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||1.9|-8.9|
73862172|NCT00159913|147270322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-12.4|-2.1|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||-2.1|-12.4|
74028701|NCT01096667|147611180|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.2||||0.196|TWO_SIDED|80.0|-3.01|0.6||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.60|-3.01|0.196
73862173|NCT00159913|147270323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.0||0.041||95.0|-8.0|-0.2|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||-0.2|-8.0|0.041
73862174|NCT00159913|147270323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.7||||95.0|-5.9|4.7|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||4.7|-5.9|
74028702|NCT01096667|147611180|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.05||||0.229|TWO_SIDED|80.0|-2.86|0.77||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.77|-2.86|0.229
73924649|NCT03615326|147378151|SUPERIORITY|The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Hazard Ratio (HR)|0.8||||0.004|TWO_SIDED|95.0|0.67|0.94|||Log Rank|One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|OS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||0.94|0.67|0.0040
73924650|NCT03615326|147378152|SUPERIORITY|The difference in percentage and its 95% confidence interval (CI) were estimated using the Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Difference in Percentage|12.6||||0.0002|TWO_SIDED|95.0|5.6|19.4||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen Method|||ORR in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||19.4|5.6|0.00020
73924651|NCT02864251|147378179|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0528|TWO_SIDED|95.0|0.56|1.0||Log-rank test stratified by PD-L1 expression (\>= 1% vs \<1%/indeterminate/not evaluable), brain metastases (presence vs absence), smoking history (current/former vs never smoker), and prior osimertinib use (yes vs no) from IRT.|Log Rank||Arm A over Arm C Stratified Cox proportional hazard model.|||1.00|0.56|0.0528
73924652|NCT02864251|147378179|SUPERIORITY||Hazard Ratio (HR)|2.07|||||TWO_SIDED|95.0|1.43|2.99|||||Arm B over Arm C Stratified Cox proportional hazard model.|||2.99|1.43|
73924653|NCT02864251|147378180|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.218|TWO_SIDED|95.0|0.62|1.12|||Log Rank||Hazard Ratio (Arm A over Arm C) is based on a stratified Cox proportional hazard model|||1.12|0.62|0.2180
73924654|NCT02864251|147378180|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.75|1.52|||||Hazard Ratio (Arm B over Arm C) is based on a stratified Cox proportional hazard model.|||1.52|0.75|
73924655|NCT02864251|147378181|SUPERIORITY||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.75|2.16|||||Strata adjusted odds ratio (Arm A over Arm C) using Mantel-Haenszel method.|||2.16|0.75|
73924656|NCT00973479|147378241|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73924657|NCT00973479|147378242|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73924658|NCT00973479|147378243|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA of van der Waerden scores|||||||<0.001
73968323|NCT00999804|147474885|SUPERIORITY_OR_OTHER_LEGACY||proportion of patients with AE|0.72|||||TWO_SIDED||||||||61 out of 85 patients (72%) in the 24-week arm had at least 1 adverse events.|This outcome is to establish the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy. No comparison between the 2 arms is required.||||
73968324|NCT00999804|147474886|SUPERIORITY_OR_OTHER_LEGACY||proportion of tpCR in 24 weeks arm|0.1|||||TWO_SIDED|||||||||No comparison between the two arms is required.||||
74087139|NCT02310763|147728270|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-31.6||||0.1669|TWO_SIDED|95.0|-76.9|13.6|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||13.6|-76.9|0.1669
74087140|NCT02310763|147728271|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-66.3||||0.0267|TWO_SIDED|95.0|-124.5|-8.1|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||-8.1|-124.5|0.0267
74028703|NCT01096667|147611180|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.02||||0.017|TWO_SIDED|80.0|-4.83|-1.2||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.20|-4.83|0.017
73924659|NCT00973479|147378244|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73924660|NCT00973479|147378245|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA of van der Waerden scores|||||||<0.001
73924661|NCT00362115|147378246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0631|TWO_SIDED|95.0|-5.96|0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.16|-5.96|0.0631
73968325|NCT00999804|147474887|SUPERIORITY_OR_OTHER_LEGACY||proportion of CR+PR in 24 weeks arm|0.69|||||TWO_SIDED|||||||||No comparison between the 2 arm is required for this study.||||
73924662|NCT00362115|147378246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.0008|TWO_SIDED|95.0|-8.33|-2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.20|-8.33|0.0008
73924663|NCT00362115|147378246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.0188|TWO_SIDED|95.0|-6.73|-0.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.61|-6.73|0.0188
73924664|NCT00362115|147378246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0003|TWO_SIDED|95.0|-8.8|-2.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.63|-8.80|0.0003
73968326|NCT05229146|147474888|SUPERIORITY|||||||0.191||||||No adjustment for multiple comparisons.|t-test, 1 sided|t-statistic = .913, df = 10||One-sided paired-samples t-test comparing baseline to responses immediately following the intervention (approximately one week after baseline).||||.191
74087141|NCT02310763|147728272|SUPERIORITY||Mean Difference (Net)|-0.0692||||0.7033|TWO_SIDED|95.0|-0.4345|0.2961||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.2961|-0.4345|0.7033
73924665|NCT00362115|147378246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.0177|TWO_SIDED|95.0|-6.77|-0.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.65|-6.77|0.0177
73924666|NCT00362115|147378246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.855||95.0|-2.72|3.27||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.27|-2.72|0.8550
73924667|NCT00362115|147378246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1719|TWO_SIDED|95.0|-5.08|0.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.91|-5.08|0.1719
73924668|NCT00362115|147378246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7469|TWO_SIDED|95.0|-3.49|2.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.50|-3.49|0.7469
73924669|NCT00362115|147378246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.1001|TWO_SIDED|95.0|-5.55|0.49||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.49|-5.55|0.1001
73924670|NCT00362115|147378246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7294|TWO_SIDED|95.0|-3.52|2.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.47|-3.52|0.7294
73924671|NCT00362115|147378247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0111|TWO_SIDED|95.0|-10.84|-1.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.41|-10.84|0.0111
73924672|NCT00362115|147378247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||<|0.0001|TWO_SIDED|95.0|-15.51|-6.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.08|-15.51|< 0.0001
73924673|NCT00362115|147378247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8|||<|0.0001|TWO_SIDED|95.0|-14.53|-5.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.10|-14.53|< 0.0001
73968327|NCT05229146|147474888|SUPERIORITY|||||||0.043||||||Not adjusted for multiple comparisons.|t-test, 1 sided|t-statistic = 1.92, df = 9||One-sided paired-samples t-test comparing baseline to responses at two week follow-up (approximately four weeks after baseline).||||.043
73968328|NCT05229146|147474889|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.319|TWO_SIDED|||||No adjustments were made. DF = 15.|t-test, 2 sided|||Comparison is between future orientation subscale pre- and post-subscale scores.||||.319
73968329|NCT05229146|147474889|SUPERIORITY||Mean Difference (Final Values)|-0.711||||0.488|TWO_SIDED||||||t-test, 2 sided|No adjustments were made. DF = 15.||Comparison between immediate-orientation subscales.||||.488
73968330|NCT05229146|147474890|SUPERIORITY||Mean Difference (Final Values)|0.438||||0.34|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||Performed a paired-samples one-sided t-test comparing positive parenting before the intervention to after the intervention.||||.34
74087142|NCT02310763|147728272|SUPERIORITY||Mean Difference (Net)|0.2114||||0.6893|TWO_SIDED|95.0|-0.8472|1.27||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||1.27|-0.8472|0.6893
74087143|NCT02310763|147728272|SUPERIORITY||Mean Difference (Net)|-2.6439||||0.6469|TWO_SIDED|95.0|-14.4292|9.1414||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||9.1414|-14.4292|0.6469
73968331|NCT05229146|147474890|SUPERIORITY||Mean Difference (Final Values)|-0.363||||0.362|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||Performed a one-sided paired-samples t-test to compare negative parenting before and after the intervention.||||.362
73968332|NCT05229146|147474891|SUPERIORITY||Mean Difference (Final Values)|-3.77|||<|0.001|ONE_SIDED||||||t-test, 1 sided|No adjustments, DF = 15||Used a one-sided paired samples t-test to examine changes in the parental involvement subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||<.001
74087144|NCT02310763|147728273|SUPERIORITY||Mean Difference (Net)|-0.3289||||0.1353|TWO_SIDED|95.0|-0.7649|0.1072||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1072|-0.7649|0.1353
73924674|NCT00362115|147378247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.02|-7.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.52|-17.02|< 0.0001
73924675|NCT00362115|147378247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5||||0.0005|TWO_SIDED|95.0|-13.19|-3.76||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.76|-13.19|0.0005
73924676|NCT00362115|147378247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.2768|TWO_SIDED|95.0|-2.06|7.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.17|-2.06|0.2768
73924677|NCT00362115|147378247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.3688|TWO_SIDED|95.0|-6.74|2.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.51|-6.74|0.3688
73968333|NCT05229146|147474891|SUPERIORITY||Median Difference (Final Values)|-1.14||||0.137|ONE_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in the positive parenting subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.137
73968334|NCT05229146|147474891|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.018|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15.||Used a one-sided paired samples t-test to examine changes in the inconsistent discipline subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.018
74087145|NCT02310763|147728273|SUPERIORITY||Mean Difference (Net)|0.3457||||0.7648|TWO_SIDED|95.0|-1.9614|2.6528||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||2.6528|-1.9614|0.7648
73924678|NCT00362115|147378247|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1||||0.6293|TWO_SIDED|95.0|-5.75|3.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.48|-5.75|0.6293
73924679|NCT00362115|147378247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.1298|TWO_SIDED|95.0|-8.25|1.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.06|-8.25|0.1298
73924680|NCT00362115|147378247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9315|TWO_SIDED|95.0|-4.41|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.82|-4.41|0.9315
73924681|NCT00362115|147378248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.0016|TWO_SIDED|95.0|-13.17|-3.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.09|-13.17|0.0016
73924682|NCT00362115|147378248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-15.17|-5.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.09|-15.17|< 0.0001
73924683|NCT00362115|147378248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.0001|TWO_SIDED|95.0|-17.8|-7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.72|-17.80|< 0.0001
73924684|NCT00362115|147378248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.36|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.20|-16.36|< 0.0001
73924685|NCT00362115|147378248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7|||<|0.0001|TWO_SIDED|95.0|-15.75|-5.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.63|-15.75|< 0.0001
73924686|NCT00362115|147378248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9909|TWO_SIDED|95.0|-4.96|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.91|-4.96|0.9909
73924687|NCT00362115|147378248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.4213|TWO_SIDED|95.0|-6.96|2.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.92|-6.96|0.4213
73924688|NCT00362115|147378248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.0646|TWO_SIDED|95.0|-9.59|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.28|-9.59|0.0646
74028704|NCT01096667|147611180|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.84||||0.021|TWO_SIDED|80.0|-4.63|-1.06||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.06|-4.63|0.021
73924689|NCT00362115|147378248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.2107|TWO_SIDED|95.0|-8.15|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.80|-8.15|0.2107
73924690|NCT00362115|147378248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.3059|TWO_SIDED|95.0|-7.54|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.37|-7.54|0.3059
74028705|NCT01096667|147611182|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.22||||0.039|TWO_SIDED|80.0|-3.83|-0.61||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.61|-3.83|0.039
74028706|NCT01096667|147611182|SUPERIORITY_OR_OTHER||Difference in least squares means|0.07||||0.521|TWO_SIDED|80.0|-1.63|1.77||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||1.77|-1.63|0.521
74028707|NCT01096667|147611182|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.39||||0.031|TWO_SIDED|80.0|-4.02|-0.75||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.75|-4.02|0.031
74028708|NCT01096667|147611182|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.56||||0.11|TWO_SIDED|80.0|-3.19|0.07||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.07|-3.19|0.110
74028709|NCT01096667|147611183|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.38||||0.007|TWO_SIDED|80.0|-5.13|-1.63||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.63|-5.13|0.007
73924691|NCT00362115|147378249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1653|TWO_SIDED|95.0|-5.69|0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.98|-5.69|0.1653
73924692|NCT00362115|147378249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.0151|TWO_SIDED|95.0|-7.5|-0.81||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.81|-7.50|0.0151
73924693|NCT00362115|147378249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.048|TWO_SIDED|95.0|-6.7|-0.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.03|-6.70|0.0480
73924694|NCT00362115|147378249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0098|TWO_SIDED|95.0|-7.81|-1.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.08|-7.81|0.0098
73924695|NCT00362115|147378249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0113|TWO_SIDED|95.0|-7.68|-0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.98|-7.68|0.0113
74028710|NCT01096667|147611183|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.48||||0.37|TWO_SIDED|80.0|-2.33|1.38||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||1.38|-2.33|0.370
73924696|NCT00362115|147378249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.3416|TWO_SIDED|95.0|-1.68|4.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.84|-1.68|0.3416
73924697|NCT00362115|147378249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8973|TWO_SIDED|95.0|-3.49|3.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.06|-3.49|0.8973
73924698|NCT00362115|147378249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.7292|TWO_SIDED|95.0|-2.69|3.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.84|-2.69|0.7292
73924699|NCT00362115|147378249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7646|TWO_SIDED|95.0|-3.79|2.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.79|-3.79|0.7646
74028711|NCT01096667|147611183|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.65||||0.029|TWO_SIDED|80.0|-4.43|-0.87||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.87|-4.43|0.029
73924700|NCT00362115|147378249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8133|TWO_SIDED|95.0|-3.67|2.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.88|-3.67|0.8133
73924701|NCT00362115|147378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-12.51|-4.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.51|-12.51|< 0.0001
73924702|NCT00362115|147378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||<|0.0001|TWO_SIDED|95.0|-17.31|-8.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.90|-17.31|< 0.0001
73924703|NCT00362115|147378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|||<|0.0001|TWO_SIDED|95.0|-16.27|-7.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.95|-16.27|< 0.0001
73924704|NCT00362115|147378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.0001|TWO_SIDED|95.0|-21.07|-12.46||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-12.46|-21.07|< 0.0001
73924705|NCT00362115|147378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.4|||<|0.0001|TWO_SIDED|95.0|-17.58|-9.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.17|-17.58|< 0.0001
73924706|NCT00362115|147378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.3735|TWO_SIDED|95.0|-2.1|5.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.58|-2.10|0.3735
73924707|NCT00362115|147378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.1668|TWO_SIDED|95.0|-6.91|1.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.20|-6.91|0.1668
73924708|NCT00362115|147378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.3629|TWO_SIDED|95.0|-5.86|2.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.15|-5.86|0.3629
73862175|NCT00159913|147270323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-9.3|0.3|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||0.3|-9.3|
73924709|NCT00362115|147378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0022|TWO_SIDED|95.0|-10.67|-2.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.36|-10.67|0.0022
73924710|NCT00362115|147378250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1303|TWO_SIDED|95.0|-7.18|0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.93|-7.18|0.1303
73924711|NCT00362115|147378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4|||<|0.0001|TWO_SIDED|95.0|-8.12|-2.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.72|-8.12|< 0.0001
73924712|NCT00362115|147378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.33|-5.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.65|-11.33|< 0.0001
73924713|NCT00362115|147378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.90|-11.52|< 0.0001
73924714|NCT00362115|147378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||<|0.0001|TWO_SIDED|95.0|-13.73|-7.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.91|-13.73|< 0.0001
73924715|NCT00362115|147378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||<|0.0001|TWO_SIDED|95.0|-12.31|-6.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.64|-12.31|< 0.0001
74028712|NCT01096667|147611183|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.64||||0.118|TWO_SIDED|80.0|-3.42|0.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.13|-3.42|0.118
73924716|NCT00362115|147378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.1249|TWO_SIDED|95.0|-0.56|4.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.61|-0.56|0.1249
73924717|NCT00362115|147378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.4542|TWO_SIDED|95.0|-3.79|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.70|-3.79|0.4542
73924718|NCT00362115|147378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.3574|TWO_SIDED|95.0|-3.97|1.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.44|-3.97|0.3574
73924719|NCT00362115|147378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.0184|TWO_SIDED|95.0|-6.18|-0.57||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.57|-6.18|0.0184
73924720|NCT00362115|147378251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.145|TWO_SIDED|95.0|-4.77|0.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.70|-4.77|0.1450
73924721|NCT00362115|147378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9||||0.0009|TWO_SIDED|95.0|-12.46|-3.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.26|-12.46|0.0009
73924722|NCT00362115|147378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-18.46|-8.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.77|-18.46|< 0.0001
73924723|NCT00362115|147378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-17.21|-7.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.63|-17.21|< 0.0001
73924724|NCT00362115|147378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-22.83|-12.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-12.92|-22.83|< 0.0001
73924725|NCT00362115|147378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.52|-8.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.84|-18.52|< 0.0001
73924726|NCT00362115|147378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9424|TWO_SIDED|95.0|-4.25|4.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.58|-4.25|0.9424
73924727|NCT00362115|147378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.0189|TWO_SIDED|95.0|-10.26|-0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.93|-10.26|0.0189
73924728|NCT00362115|147378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0612|TWO_SIDED|95.0|-9.01|0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.21|-9.01|0.0612
73924729|NCT00362115|147378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.63|-5.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.07|-14.63|< 0.0001
73924730|NCT00362115|147378252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0175|TWO_SIDED|95.0|-10.33|-1.0||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.00|-10.33|0.0175
73968335|NCT05229146|147474891|SUPERIORITY||Mean Difference (Final Values)|2.39||||0.015|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15.||Used a one-sided paired samples t-test to examine changes in the use of corporal punishment subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.015
73968336|NCT05229146|147474891|SUPERIORITY||Mean Difference (Final Values)|2.23||||0.021|ONE_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in the poor parental monitoring/supervision subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.021
74087146|NCT02310763|147728273|SUPERIORITY||Mean Difference (Net)|8.2893||||0.3562|TWO_SIDED|95.0|-9.6409|26.2194||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||26.2194|-9.6409|0.3562
73862176|NCT00159913|147270323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|2.3||||95.0|-11.7|-2.7|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||-2.7|-11.7|
73924731|NCT00362115|147378253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.0108|TWO_SIDED|95.0|-7.26|-0.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.95|-7.26|0.0108
73924732|NCT00362115|147378253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|||<|0.0001|TWO_SIDED|95.0|-11.16|-4.55||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.55|-11.16|< 0.0001
73924733|NCT00362115|147378253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.82|-5.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.26|-11.82|< 0.0001
73924734|NCT00362115|147378253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|||<|0.0001|TWO_SIDED|95.0|-13.98|-7.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.20|-13.98|< 0.0001
73924735|NCT00362115|147378253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||<|0.0001|TWO_SIDED|95.0|-12.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.90|-12.52|< 0.0001
74087147|NCT02310763|147728274|SUPERIORITY||Mean Difference (Net)|-0.5582||||0.1163||95.0|-1.2615|0.1451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1451|-1.2615|0.1163
73924736|NCT00362115|147378253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.306|TWO_SIDED|95.0|-1.45|4.59||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.59|-1.45|0.3060
73924737|NCT00362115|147378253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.1823|TWO_SIDED|95.0|-5.37|1.02||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.02|-5.37|0.1823
73924738|NCT00362115|147378253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0751|TWO_SIDED|95.0|-6.01|0.29||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.29|-6.01|0.0751
74087148|NCT02310763|147728274|SUPERIORITY||Mean Difference (Net)|0.0944||||0.9503|TWO_SIDED|95.0|-3.0798|3.2686||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.2686|-3.0798|0.9503
73924739|NCT00362115|147378253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0034|TWO_SIDED|95.0|-8.18|-1.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.64|-8.18|0.0034
73924740|NCT00362115|147378253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0306|TWO_SIDED|95.0|-6.72|-0.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.33|-6.72|0.0306
73924741|NCT00362115|147378254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.0061|TWO_SIDED|95.0|-13.9|-2.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.33|-13.90|0.0061
73924742|NCT00362115|147378254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.5||||0.0002|TWO_SIDED|95.0|-17.56|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.44|-17.56|0.0002
73924743|NCT00362115|147378254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-18.34|-6.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.28|-18.34|< 0.0001
74087149|NCT02310763|147728274|SUPERIORITY||Mean Difference (Net)|-11.2881||||0.2947|TWO_SIDED|95.0|-32.8328|10.2566||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||10.2566|-32.8328|0.2947
73924744|NCT00362115|147378254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|||<|0.0001|TWO_SIDED|95.0|-23.75|-11.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.34|-23.75|< 0.0001
73924745|NCT00362115|147378254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|||<|0.0001|TWO_SIDED|95.0|-19.86|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.80|-19.86|< 0.0001
73924746|NCT00362115|147378254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.9355|TWO_SIDED|95.0|-5.74|5.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.28|-5.74|0.9355
73924747|NCT00362115|147378254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.2223|TWO_SIDED|95.0|-9.41|2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.20|-9.41|0.2223
73924748|NCT00362115|147378254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1328|TWO_SIDED|95.0|-10.19|1.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.35|-10.19|0.1328
73924749|NCT00362115|147378254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7||||0.0016|TWO_SIDED|95.0|-15.61|-3.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.70|-15.61|0.0016
73968337|NCT05229146|147474892|SUPERIORITY||Mean Difference (Final Values)|0.878||||0.197|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15||Used a one-sided paired-samples t-test to examine changes in emotion regulation subscale from pre-intervention to post-intervention.||||.197
74087150|NCT02310763|147728275|SUPERIORITY||Mean Difference (Net)|0.0159||||0.8229|TWO_SIDED|95.0|-0.127|0.1588||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1588|-0.1270|0.8229
73924750|NCT00362115|147378254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.0437|TWO_SIDED|95.0|-11.7|-0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.17|-11.70|0.0437
73924751|NCT00362115|147378255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0417|TWO_SIDED|95.0|-8.39|-0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.16|-8.39|0.0417
73924752|NCT00362115|147378255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0053|TWO_SIDED|95.0|-10.44|-1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.84|-10.44|0.0053
73968338|NCT05229146|147474892|SUPERIORITY||Mean Difference (Final Values)|0.857||||0.203|ONE_SIDED||||||t-test, 1 sided|No adjustments, DF = 15.||Used a one-sided paired-samples t-test to examine changes in lability/negativity subscale from pre-intervention to post-intervention.||||.203
73968339|NCT03850678|147474921|SUPERIORITY|||||||0.774|||||||ANOVA|||This analysis examined Q10 for those participants who completed the compression speed experiment (instant, fast, slow).||||.774
73968340|NCT03850678|147474921|SUPERIORITY||||||<|0.001|||||||ANOVA|||This analysis examined Q10 for those participants who completed the compression channel conditions (4, 8, 16).||||<.001
73968341|NCT03850678|147474921|SUPERIORITY|||||||0.167|||||||ANOVA|||This analysis compared Q10 for those participants who completed the unaided and aided conditions.||||.167
73968342|NCT03850678|147474922|SUPERIORITY|||||||0.741|||||||ANOVA|||Statistical analysis of number of compression channels (unaided, 4 channel, 16 channels)||||.741
73862177|NCT00159913|147270324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|2.36||0.795||95.0|-4.07|5.3|||ANCOVA|The model included the covariates etiology and weight group||||5.30|-4.07|0.795
73862178|NCT00159913|147270324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.62|STANDARD_ERROR_OF_MEAN|2.99||||95.0|-3.31|8.54|||ANCOVA|The model included the covariates etiology and weight group||||8.54|-3.31|
73862179|NCT00159913|147270324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|2.92||||95.0|-7.09|4.5|||ANCOVA|The model included the covariates etiology and weight group||||4.50|-7.09|
73862180|NCT00159913|147270324|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|2.9||||95.0|-5.24|6.28|||ANCOVA|The model included the covariates etiology and weight group||||6.28|-5.24|
73862181|NCT00159913|147270325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.24|STANDARD_ERROR_OF_MEAN|6.2||0.139||95.0|-3.05|21.54|||ANCOVA|The model included the covariates etiology and weight group||||21.54|-3.05|0.139
73924753|NCT00362115|147378255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8||||0.0004|TWO_SIDED|95.0|-12.12|-3.56||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.56|-12.12|0.0004
73924754|NCT00362115|147378255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|||<|0.0001|TWO_SIDED|95.0|-13.97|-5.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.16|-13.97|< 0.0001
73924755|NCT00362115|147378255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-13.6|-5.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.03|-13.60|< 0.0001
73862182|NCT00159913|147270325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.34|STANDARD_ERROR_OF_MEAN|7.84||||95.0|-5.21|25.9|||ANCOVA|The model included the covariates etiology and weight group||||25.90|-5.21|
73862183|NCT00159913|147270325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.43|STANDARD_ERROR_OF_MEAN|7.67||||95.0|-3.78|26.64|||ANCOVA|The model included the covariates etiology and weight group||||26.64|-3.78|
73862184|NCT00159913|147270325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|7.62||||95.0|-9.16|21.08|||ANCOVA|The model included the covariates etiology and weight group||||21.08|-9.16|
73862185|NCT00159913|147270326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.1||0.172||95.0|-7.1|1.3|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.3|-7.1|0.172
73862186|NCT00159913|147270326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.9||||95.0|-5.5|5.9|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||5.9|-5.5|
73862187|NCT00159913|147270326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-8.5|1.7|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.7|-8.5|
73862188|NCT00159913|147270326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-10.3|-0.7|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||-0.7|-10.3|
73862189|NCT00159913|147270327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.3||0.015||95.0|0.14|1.34|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.34|0.14|0.015
73862190|NCT00159913|147270327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.41||||95.0|-0.1|1.52|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.52|-0.10|
73862191|NCT00159913|147270327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.37||||95.0|-0.12|1.35|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.35|-0.12|
73862192|NCT00159913|147270327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.35||||95.0|0.21|1.58|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.58|0.21|
73862193|NCT00159913|147270328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.64||0.44||95.0|-1.77|0.77|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||0.77|-1.77|0.440
73862194|NCT00159913|147270328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.88||||95.0|-1.91|1.57|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.57|-1.91|
73862195|NCT00159913|147270328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.78||||95.0|-1.73|1.36|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.36|-1.73|
73862196|NCT00159913|147270328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.75||||95.0|-2.61|0.33|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||0.33|-2.61|
73924756|NCT00362115|147378255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.6372|TWO_SIDED|95.0|-2.97|4.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.85|-2.97|0.6372
73924757|NCT00362115|147378255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.6588|TWO_SIDED|95.0|-5.05|3.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.20|-5.05|0.6588
73924758|NCT00362115|147378255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2082|TWO_SIDED|95.0|-6.72|1.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.47|-6.72|0.2082
73924759|NCT00362115|147378255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0437|TWO_SIDED|95.0|-8.57|-0.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.12|-8.57|0.0437
73924760|NCT00362115|147378255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.0495|TWO_SIDED|95.0|-8.19|-0.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.01|-8.19|0.0495
73924761|NCT00362115|147378256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4||||0.0007|TWO_SIDED|95.0|-14.74|-3.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.97|-14.74|0.0007
73924762|NCT00362115|147378256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.4|||<|0.0001|TWO_SIDED|95.0|-19.02|-7.73||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.73|-19.02|< 0.0001
73924763|NCT00362115|147378256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.0003|TWO_SIDED|95.0|-16.0|-4.83||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.83|-16.00|0.0003
73924764|NCT00362115|147378256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.3|||<|0.0001|TWO_SIDED|95.0|-23.11|-11.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.47|-23.11|< 0.0001
73924765|NCT00362115|147378256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-18.01|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.78|-18.01|< 0.0001
73924766|NCT00362115|147378256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.2594|TWO_SIDED|95.0|-2.17|8.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||8.01|-2.17|0.2594
73924767|NCT00362115|147378256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.6859|TWO_SIDED|95.0|-6.46|4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.26|-6.46|0.6859
73924768|NCT00362115|147378256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.4898|TWO_SIDED|95.0|-3.43|7.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.15|-3.43|0.4898
73924769|NCT00362115|147378256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0||||0.076|TWO_SIDED|95.0|-10.55|0.53||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.53|-10.55|0.0760
73924770|NCT00362115|147378256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9647|TWO_SIDED|95.0|-5.44|5.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.21|-5.44|0.9647
73968343|NCT03850678|147474922|SUPERIORITY|||||||0.062||||||Due to Levene's Test for Equality of Variances, equal variances were not assumed.|t-test, 1 sided|||Spatial Release from Masking, unaided.||||.062
73862197|NCT00159913|147270329|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|1.93||0.75||95.0|-4.45|3.21|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.||||3.21|-4.45|0.750
73924771|NCT00362115|147378257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.0002|TWO_SIDED|95.0|-11.13|-3.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.43|-11.13|0.0002
73924772|NCT00362115|147378257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.01|-6.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.97|-15.01|< 0.0001
73924773|NCT00362115|147378257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.59|-4.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.64|-12.59|< 0.0001
73924774|NCT00362115|147378257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-17.79|-9.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.50|-17.79|< 0.0001
73924775|NCT00362115|147378257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-12.69|-4.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.70|-12.69|< 0.0001
73924776|NCT00362115|147378257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.279|TWO_SIDED|95.0|-1.63|5.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.62|-1.63|0.2790
73924777|NCT00362115|147378257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3772|TWO_SIDED|95.0|-5.53|2.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.10|-5.53|0.3772
73924778|NCT00362115|147378257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.7302|TWO_SIDED|95.0|-3.11|4.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.43|-3.11|0.7302
73924779|NCT00362115|147378257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0302|TWO_SIDED|95.0|-8.31|-0.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.42|-8.31|0.0302
73924780|NCT00362115|147378257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.7644|TWO_SIDED|95.0|-3.22|4.38||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.38|-3.22|0.7644
73862198|NCT00159913|147270329|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|2.57||||95.0|-4.21|5.95|||ANCOVA|||||5.95|-4.21|
73862199|NCT00159913|147270329|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.49||||95.0|-4.68|5.15|||ANCOVA|||||5.15|-4.68|
73862200|NCT00159913|147270329|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.96|STANDARD_ERROR_OF_MEAN|2.23||||95.0|-7.37|1.45|||ANCOVA|||||1.45|-7.37|
73862201|NCT00159913|147270330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|1.51||0.784||95.0|-3.41|2.58|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.||||2.58|-3.41|0.784
73862202|NCT00159913|147270330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.97||||95.0|-3.49|4.3|||ANCOVA|||||4.30|-3.49|
73862203|NCT00159913|147270330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|1.96||||95.0|-5.99|1.77|||ANCOVA|||||1.77|-5.99|
73862204|NCT00159913|147270330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|1.77||||95.0|-3.06|3.97|||ANCOVA|||||3.97|-3.06|
73862205|NCT00159913|147270331|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83||||0.184||95.0|0.75|4.45|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||4.45|0.75|0.184
73862206|NCT00159913|147270331|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.6||||0.409||95.0|0.18|2.01|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||2.01|0.18|0.409
73862207|NCT00159913|147270331|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.146||95.0|0.75|6.69|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||6.69|0.75|0.146
73862208|NCT00159913|147270331|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.52||||0.006||95.0|1.56|13.1|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||13.10|1.56|0.006
73862209|NCT00159913|147270332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.89|STANDARD_ERROR_OF_MEAN|4.35||0.179||95.0|-2.74|14.53|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||14.53|-2.74|0.179
73862210|NCT00159913|147270332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|5.35||||95.0|-9.49|11.77|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||11.77|-9.49|
73862211|NCT00159913|147270332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|5.36||||95.0|0.66|21.96|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||21.96|0.66|
73862212|NCT00159913|147270332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.24|STANDARD_ERROR_OF_MEAN|5.16||||95.0|-5.02|15.5|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||15.50|-5.02|
73862213|NCT01394614|147270339|SUPERIORITY_OR_OTHER||Incidence-rate difference|0.41|||||TWO_SIDED||||||||Difference between the incidence rate of exposed-to-vaccine cases (0.52) and that of unexposed cases (0.11) is 0.41 per 100,000 persons-years|||||
73862214|NCT01394614|147270339|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.32|||||TWO_SIDED|95.0|1.5|11.12|||||Risk of developing narcolepsy if exposed to H1N1 vaccination (using the 16-week post-vaccination period as reference).|||11.12|1.5|
73862215|NCT01318070|147270340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.179|||||TWO_SIDED|95.0|-0.224|-0.135||||||||-0.135|-0.224|
73862216|NCT01318070|147270340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.225|-0.135||||||||-0.135|-0.225|
73862217|NCT01318070|147270341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.363|||||TWO_SIDED|95.0|-0.434|-0.292||||||||-0.292|-0.434|
73862218|NCT01318070|147270341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.359|||||TWO_SIDED|95.0|-0.432|-0.287||||||||-0.287|-0.432|
73862219|NCT01318070|147270342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.588|||||TWO_SIDED|95.0|-0.692|-0.484||||||||-0.484|-0.692|
73862220|NCT01318070|147270342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.635|||||TWO_SIDED|95.0|-0.743|-0.526||||||||-0.526|-0.743|
73862221|NCT01318070|147270343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83|||||TWO_SIDED|95.0|-13.2|-4.47||||||||-4.47|-13.20|
73862222|NCT01318070|147270343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.06|||||TWO_SIDED|95.0|-17.86|-8.26||||||||-8.26|-17.86|
73862223|NCT01318070|147270344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.24|||||TWO_SIDED|95.0|-16.22|-6.25||||||||-6.25|-16.22|
73862224|NCT01318070|147270344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.82|||||TWO_SIDED|95.0|-20.0|-9.63||||||||-9.63|-20.00|
73862225|NCT01318070|147270345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.88|||||TWO_SIDED|95.0|-18.09|-7.68||||||||-7.68|-18.09|
73862226|NCT01318070|147270345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.08|||||TWO_SIDED|95.0|-22.64|-11.53||||||||-11.53|-22.64|
73862227|NCT01318070|147270346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.46|||||TWO_SIDED|95.0|-18.51|-6.4||||||||-6.40|-18.51|
73862228|NCT01318070|147270346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.49|||||TWO_SIDED|95.0|-22.78|-10.19||||||||-10.19|-22.78|
73862229|NCT01318070|147270347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.31|||||TWO_SIDED|95.0|-21.51|-3.1||||||||-3.10|-21.51|
73862230|NCT01318070|147270347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.19|||||TWO_SIDED|95.0|-30.43|-11.95||||||||-11.95|-30.43|
73862231|NCT01318070|147270348|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.717|||||TWO_SIDED|95.0|-0.848|-0.586||||||||-0.586|-0.848|
73862232|NCT01318070|147270348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.773|||||TWO_SIDED|95.0|-0.913|-0.634||||||||-0.634|-0.913|
73862233|NCT01173029|147270380|NON_INFERIORITY_OR_EQUIVALENCE|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|1.7||||0.19|TWO_SIDED|95.0|0.7|4.1||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' tests Yates's corrected Chi-squared or Fisher's exact test, when appropriate Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"||4.1|0.7|0.19
73924781|NCT00362115|147378258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.4||||0.0001|TWO_SIDED|95.0|-12.7|-4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.19|-12.70|0.0001
73924782|NCT00362115|147378258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.19|-9.24||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.24|-18.19|< 0.0001
73924783|NCT00362115|147378258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|||<|0.0001|TWO_SIDED|95.0|-16.66|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.80|-16.66|< 0.0001
73968344|NCT03850678|147474923|SUPERIORITY|||||||0.805|||||||Regression, Linear|||Linear regression of score for the reading span (independent variable) to Q10 (dependent variable, 16 channel compression condition) for the participants who completed the compression channel experiment.||||.805
73968345|NCT01573442|147474928|SUPERIORITY|||||||0.4952|||||||Wilcoxon (Mann-Whitney)|||||||0.4952
73968346|NCT01573442|147474929|SUPERIORITY|||||||0.2116|||||||Fisher Exact|||||||0.2116
73968347|NCT01573442|147474930|SUPERIORITY|||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||0.6760
73968348|NCT01573442|147474931|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 1||||0.029
74028713|NCT01096667|147611184|SUPERIORITY_OR_OTHER||Difference in least squares means|0.02||||0.506|TWO_SIDED|80.0|-1.96|2.0||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||2.00|-1.96|0.506
73924784|NCT00362115|147378258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-22.51|-13.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-13.35|-22.51|< 0.0001
73968349|NCT01573442|147474931|SUPERIORITY|||||||0.8214|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 2||||0.8214
73968350|NCT01573442|147474931|SUPERIORITY|||||||0.4952|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 3||||0.4952
73968351|NCT01573442|147474931|SUPERIORITY|||||||0.5232|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 4||||0.5232
73968352|NCT01573442|147474931|SUPERIORITY|||||||0.5522|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 5||||0.5522
73968353|NCT01573442|147474931|SUPERIORITY|||||||0.7005|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 6||||0.7005
73924785|NCT00362115|147378258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.21|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.25|-18.21|< 0.0001
74028714|NCT01096667|147611184|SUPERIORITY_OR_OTHER||Difference in least squares means|1.61||||0.838|TWO_SIDED|80.0|-0.49|3.71||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||3.71|-0.49|0.838
73968354|NCT01573442|147474935|SUPERIORITY|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.139
73968355|NCT01573442|147474936|SUPERIORITY|||||||0.8761|||||||Wilcoxon (Mann-Whitney)|||||||0.8761
73968356|NCT01573442|147474937|SUPERIORITY|||||||0.0176|||||||Wilcoxon (Mann-Whitney)|||||||0.0176
73968357|NCT01573442|147474938|SUPERIORITY|||||||0.7077|||||||Wilcoxon (Mann-Whitney)|||||||0.7077
73968358|NCT01573442|147474939|SUPERIORITY|||||||0.8748|||||||Wilcoxon (Mann-Whitney)|||||||0.8748
73968359|NCT01573442|147474940|SUPERIORITY|||||||0.4335|||||||Wilcoxon (Mann-Whitney)|||||||0.4335
73968360|NCT01573442|147474941|SUPERIORITY|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||||||0.286
73968361|NCT01573442|147474942|SUPERIORITY|||||||0.7694|||||||Wilcoxon (Mann-Whitney)|||||||0.7694
73968362|NCT01573442|147474943|SUPERIORITY|||||||0.9609|||||||Wilcoxon (Mann-Whitney)|||||||0.9609
73968363|NCT04166773|147474953|SUPERIORITY||Odds Ratio (OR)|7.45|||<|0.001|TWO_SIDED|95.0|2.27|24.44|||Regression, Logistic||Odds ratio, Confidence Interval (CI), and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||24.44|2.27|<0.001
73968364|NCT04166773|147474953|SUPERIORITY||Odds Ratio (OR)|11.86|||<|0.001|TWO_SIDED|95.0|3.59|39.11|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||39.11|3.59|<0.001
73968365|NCT04166773|147474953|SUPERIORITY||Odds Ratio (OR)|19.63|||<|0.001|TWO_SIDED|95.0|5.73|67.25|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||67.25|5.73|<0.001
73968366|NCT04166773|147474954|SUPERIORITY||Odds Ratio (OR)|3.01||||0.025|TWO_SIDED|95.0|1.15|7.9|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||7.90|1.15|0.025
73968367|NCT04166773|147474954|SUPERIORITY||Odds Ratio (OR)|2.37||||0.074|TWO_SIDED|95.0|0.92|6.13|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors|||6.13|0.92|0.074
73968368|NCT04166773|147474954|SUPERIORITY||Odds Ratio (OR)|2.47||||0.063|TWO_SIDED|95.0|0.95|6.4|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||6.40|0.95|0.063
74028715|NCT01096667|147611184|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.82||||0.123|TWO_SIDED|80.0|-3.82|0.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.19|-3.82|0.123
74028716|NCT01096667|147611184|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.07||||0.246|TWO_SIDED|80.0|-3.06|0.93||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.93|-3.06|0.246
73862234|NCT01173029|147270381|NON_INFERIORITY_OR_EQUIVALENCE|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|2.6||||0.01|TWO_SIDED|95.0|1.01|7.3||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' test Yates' corrected Chi-squared or Fisher's exact test Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"||7.3|1.01|0.01
73924786|NCT00362115|147378258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.6905|TWO_SIDED|95.0|-3.26|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.91|-3.26|0.6905
73924787|NCT00362115|147378258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0433|TWO_SIDED|95.0|-8.76|-0.13||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.13|-8.76|0.0433
73924788|NCT00362115|147378258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.1736|TWO_SIDED|95.0|-7.22|1.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.31|-7.22|0.1736
73924789|NCT00362115|147378258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7||||0.0001|TWO_SIDED|95.0|-13.08|-4.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.23|-13.08|0.0001
73924790|NCT00362115|147378258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.0429|TWO_SIDED|95.0|-8.77|-0.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANOVA|||||-0.14|-8.77|0.0429
73862235|NCT01173029|147270381|NON_INFERIORITY_OR_EQUIVALENCE|Proportional-risk hypothesis was tested using the correlation between Schoenfeld's residuals and time (Schoenfeld's global test). The correlation rho was -0.08, Chi-squared was 0.12, and p was 0.73. Therefore, the hypothesis of proportional risk was accepted, validating the correct application model.|Hazard Ratio (HR)|2.2||||0.04|TWO_SIDED|95.0|1.1|4.8||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic groups|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for both groups.||Cox proportional hazard model for the composite endpoint (stroke + myocardial infarction) was assessed. By taking pseudo-resistant arterial hypertension as baseline reference, the hazard ratio for the composite endpoint was calculated.||4.8|1.1|0.04
73924791|NCT00362115|147378259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0009|TWO_SIDED|95.0|-7.77|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-7.77|0.0009
73924792|NCT00362115|147378259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|||<|0.0001|TWO_SIDED|95.0|-11.33|-5.32||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.32|-11.33|< 0.0001
73968369|NCT04166773|147474955|SUPERIORITY||Odds Ratio (OR)|0.91||||0.893|TWO_SIDED|95.0|0.25|3.4|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||3.40|0.25|0.893
73968370|NCT04166773|147474955|SUPERIORITY||Odds Ratio (OR)|0.73||||0.647|TWO_SIDED|95.0|0.18|2.87|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||2.87|0.18|0.647
73968371|NCT04166773|147474955|SUPERIORITY||Odds Ratio (OR)|0.39||||0.246|TWO_SIDED|95.0|0.08|1.91|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||1.91|0.08|0.246
73968372|NCT04166773|147474956|SUPERIORITY||Odds Ratio (OR)|6.94|||<|0.001|TWO_SIDED|95.0|2.41|20.0|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||20.00|2.41|<0.001
73968373|NCT04166773|147474956|SUPERIORITY||Odds Ratio (OR)|10.46|||<|0.001|TWO_SIDED|95.0|3.36|32.61|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||32.61|3.36|<0.001
73968374|NCT04166773|147474956|SUPERIORITY||Odds Ratio (OR)|12.85|||<|0.001|TWO_SIDED|95.0|3.87|42.65|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||42.65|3.87|<0.001
73924793|NCT00362115|147378259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.63|-5.67||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.67|-11.63|< 0.0001
73924794|NCT00362115|147378259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-14.34|-8.18||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.18|-14.34|< 0.0001
73924795|NCT00362115|147378259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|||<|0.0001|TWO_SIDED|95.0|-12.37|-6.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.36|-12.37|< 0.0001
73924796|NCT00362115|147378259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.2068|TWO_SIDED|95.0|-0.98|4.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.50|-0.98|0.2068
73968375|NCT04166773|147474957|SUPERIORITY||LS Mean difference (Final Values)|-8.81|STANDARD_ERROR_OF_MEAN|1.632|<|0.001|TWO_SIDED|95.0|-12.04|-5.58|||Mixed Models Analysis|||||-5.58|-12.04|<0.001
73968376|NCT04166773|147474957|SUPERIORITY||LS Mean difference (Final Values)|-8.83|STANDARD_ERROR_OF_MEAN|1.566|<|0.001|TWO_SIDED|95.0|-11.93|-5.73|||Mixed Models Analysis|||||-5.73|-11.93|<0.001
74028717|NCT01096667|147611186|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.2||||0.005|TWO_SIDED|80.0|-6.3|-2.1||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-2.10|-6.30|0.005
73862236|NCT01173029|147270382|SUPERIORITY_OR_OTHER||C-statistic|0.66|||<|0.01|TWO_SIDED|95.0|0.56|0.76||At an optimal value of \>3, polygenic risk score yielded 90% sensitivity and 40% specificity for composite endpoint.|z test|Area under receiver operating characteristic curve.|The optimal cutoff value for polygenic risk score was set to \>3.|Receiver operating characteristic curve analysis for the polygenic score as predictor of composite endpoint (stroke + myocardial infarction)||0.76|0.56|<0.01
73862237|NCT01173029|147270382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.9||||0.04|TWO_SIDED|95.0|1.2|9.2||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic group|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for polygenic risk score\<=3 and \>3.||Cox proportional hazard model of the polygenic risk score\<=3 and \> 3 for the composite endpoint (stroke + myocardial infarction). By taking polygenic risk score\<=3, the hazard ratio for the composite endpoint was calculated for polygenic risk score\>3 .||9.2|1.2|0.04
73862238|NCT00870194|147270416|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority Margin of 0.4%||||||0.012||95.0|||||Mixed Model Repeated Measures|||||||.012
73862239|NCT00870194|147270416|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.4%|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.12||0.012|TWO_SIDED|95.0|0.07|0.53|||Mixed Model Repeated Measures||Standard Error of the Least Square Mean|Power calculation: 80% assuming 200 patients (100 in each arm), no true difference and 1.0% standard deviation.||0.53|0.07|.012
73862240|NCT00870194|147270417|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Fisher's Exact Test|||||||.038
73862241|NCT00870194|147270418|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Fisher's Exact Test|||||||.027
73862242|NCT00870194|147270419|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher's Exact Test|||||||.480
73924797|NCT00362115|147378259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.2622|TWO_SIDED|95.0|-4.56|1.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.25|-4.56|0.2622
73924798|NCT00362115|147378259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.173|TWO_SIDED|95.0|-4.85|0.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.88|-4.85|0.1730
73862243|NCT00870194|147270420|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||||||.038
73862244|NCT00870194|147270421|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Mixed Model Repeated Measures|||||||.266
73968377|NCT04166773|147474957|SUPERIORITY||LS Mean difference (Final Values)|-10.02|STANDARD_ERROR_OF_MEAN|1.591|<|0.001|TWO_SIDED|95.0|-13.17|-6.87|||Mixed Models Analysis|||||-6.87|-13.17|<0.001
73968378|NCT04166773|147474958|SUPERIORITY||LS Mean difference (Final Values)|-10.42|STANDARD_ERROR_OF_MEAN|1.976|<|0.001|TWO_SIDED|95.0|-14.32|-6.52|||Mixed Models Analysis|||||-6.52|-14.32|<0.001
73862245|NCT00870194|147270422|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Mixed Model Repeated Measures|||||||.095
73862246|NCT00870194|147270423|SUPERIORITY_OR_OTHER|||||||0.567||95.0|||||Mixed Model Repeated Measures|||||||.567
73862247|NCT00870194|147270424|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||Mixed Model Repeated Measures|||||||.207
73862248|NCT00870194|147270425|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||||||.055
73862249|NCT00870194|147270426|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||ANCOVA|||||||.269
73862250|NCT00870194|147270427|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||ANCOVA|||||||.622
73862251|NCT00870194|147270428|SUPERIORITY_OR_OTHER|||||||0.888||95.0|||||ANCOVA|||||||.888
73924799|NCT00362115|147378259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.0025|TWO_SIDED|95.0|-7.56|-1.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.62|-7.56|0.0025
73862252|NCT00870194|147270429|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Fisher's Exact Test|||||||.287
73862253|NCT00870194|147270430|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||Fisher's Exact Test|||||||.498
73862254|NCT00870194|147270431|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Fisher's Exact Test|||||||.247
73862255|NCT00870194|147270432|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher's Exact Test|||||||1.00
73862256|NCT01443130|147270456|SUPERIORITY_OR_OTHER|||||||0.2441||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2441
73862257|NCT01443130|147270456|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.000
73862258|NCT01443130|147270457|SUPERIORITY_OR_OTHER|||||||0.4941||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4941
73862259|NCT01443130|147270457|SUPERIORITY_OR_OTHER|||||||0.499||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4990
73924800|NCT00362115|147378259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.0681|TWO_SIDED|95.0|-5.6|0.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.20|-5.60|0.0681
73968379|NCT04166773|147474958|SUPERIORITY||LS Mean difference (Final Values)|-13.19|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-17.05|-9.32|||Mixed Models Analysis|||||-9.32|-17.05|<0.001
73968380|NCT04166773|147474958|SUPERIORITY||LS Mean difference (Final Values)|-16.84|STANDARD_ERROR_OF_MEAN|1.957|<|0.001|TWO_SIDED|95.0|-20.71|-12.98|||Mixed Models Analysis|||||-12.98|-20.71|<0.001
74087151|NCT02310763|147728275|SUPERIORITY||Mean Difference (Net)|-0.0132||||0.7709|TWO_SIDED|95.0|-0.1036|0.0772||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||0.0772|-0.1036|0.7709
73862260|NCT01443130|147270458|SUPERIORITY_OR_OTHER|||||||0.3089||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.3089
73862261|NCT01443130|147270458|SUPERIORITY_OR_OTHER|||||||0.6973||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.6973
73862262|NCT01443130|147270459|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||1.00
73862263|NCT01443130|147270459|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.00
73924801|NCT00362115|147378260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.0004|TWO_SIDED|95.0|-13.28|-3.87||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.87|-13.28|0.0004
73924802|NCT00362115|147378260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.26|-7.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.42|-17.26|< 0.0001
73862264|NCT01443130|147270460|SUPERIORITY_OR_OTHER|||||||0.4979||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4979
73862265|NCT01443130|147270460|SUPERIORITY_OR_OTHER|||||||0.1166||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1166
73862266|NCT01443130|147270461|SUPERIORITY_OR_OTHER|||||||0.6237||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.6237
73862267|NCT01443130|147270461|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.000
73968381|NCT04717492|147474975|OTHER||Cox Proportional Hazard|1.01||||0.962|TWO_SIDED|95.0|0.66|1.54||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to death, or first hospitalization or revascularization event was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.54|0.66|0.962
73924803|NCT00362115|147378260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.51|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.78|-16.51|< 0.0001
73968382|NCT04717492|147474977|OTHER||Cox Proportional Hazard|1.11||||0.694|TWO_SIDED|95.0|0.65|1.92||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to CVD-related death or hospitalization/revascularization was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.92|0.65|0.694
73968383|NCT04717492|147474979|OTHER||Cox Proportional Hazard|0.75||||0.476|TWO_SIDED|95.0|0.34|1.66||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to respiratory/COPD-related death or hospitalization was analyzed using Cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.66|0.34|0.476
73968384|NCT04176965|147474994|NON_INFERIORITY|Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in means between the 2 groups (FINEVISION HP - AcrySof SN60AT). Non-inferiority margin = 0.10 logMAR.|Mean difference|0.045|STANDARD_ERROR_OF_MEAN|0.0084|<|0.0001|TWO_SIDED|90.0|0.0316|0.0592|||t-test, 1 sided|||||0.0592|0.0316|<0.0001
73924804|NCT00362115|147378260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.38|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.25|-19.38|< 0.0001
73924805|NCT00362115|147378260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.53|-7.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.70|-17.53|< 0.0001
73968385|NCT04176965|147474995|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73924806|NCT00362115|147378260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.1479|TWO_SIDED|95.0|-1.17|7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.72|-1.17|0.1479
73924807|NCT00362115|147378260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.8382|TWO_SIDED|95.0|-5.16|4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.19|-5.16|0.8382
73924808|NCT00362115|147378260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9317|TWO_SIDED|95.0|-4.42|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.82|-4.42|0.9317
73924809|NCT00362115|147378260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.3169|TWO_SIDED|95.0|-7.29|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.37|-7.29|0.3169
73924810|NCT00362115|147378260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.7488|TWO_SIDED|95.0|-5.44|3.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.91|-5.44|0.7488
73924811|NCT00362115|147378261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.0001|TWO_SIDED|95.0|-9.98|-3.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.40|-9.98|< 0.0001
73924812|NCT00362115|147378261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-12.76|-5.86||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.86|-12.76|< 0.0001
73924813|NCT00362115|147378261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.05|-5.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-12.05|< 0.0001
73924814|NCT00362115|147378261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||<|0.0001|TWO_SIDED|95.0|-13.92|-6.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.79|-13.92|< 0.0001
73924815|NCT00362115|147378261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||<|0.0001|TWO_SIDED|95.0|-13.11|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.20|-13.11|< 0.0001
73924816|NCT00362115|147378261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.4188|TWO_SIDED|95.0|-1.83|4.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.40|-1.83|0.4188
74028718|NCT01096667|147611186|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.12||||0.248|TWO_SIDED|80.0|-3.23|0.99||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.99|-3.23|0.248
74087152|NCT02310763|147728275|SUPERIORITY||Mean Difference (Net)|0.0889||||0.3746|TWO_SIDED|95.0|-0.1219|0.2996||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.2996|-0.1219|0.3746
73924817|NCT00362115|147378261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.4255|TWO_SIDED|95.0|-4.62|1.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.95|-4.62|0.4255
73924818|NCT00362115|147378261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.6869|TWO_SIDED|95.0|-3.91|2.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.58|-3.91|0.6869
73924819|NCT00362115|147378261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1678|TWO_SIDED|95.0|-5.77|1.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.01|-5.77|0.1678
73924820|NCT00362115|147378261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3132|TWO_SIDED|95.0|-4.96|1.6||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.60|-4.96|0.3132
73924821|NCT00362115|147378262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0||||0.0005|TWO_SIDED|95.0|-12.48|-3.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.52|-12.48|0.0005
73924822|NCT00362115|147378262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|||<|0.0001|TWO_SIDED|95.0|-15.24|-5.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.93|-15.24|< 0.0001
73924823|NCT00362115|147378262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.7|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.44|-14.70|< 0.0001
73924824|NCT00362115|147378262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|||<|0.0001|TWO_SIDED|95.0|-17.95|-8.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.42|-17.95|< 0.0001
73924825|NCT00362115|147378262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|||<|0.0001|TWO_SIDED|95.0|-16.74|-7.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.48|-16.74|< 0.0001
73924826|NCT00362115|147378262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.8103|TWO_SIDED|95.0|-4.79|3.75||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.75|-4.79|0.8103
73924827|NCT00362115|147378262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1702|TWO_SIDED|95.0|-7.57|1.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.34|-7.57|0.1702
73924828|NCT00362115|147378262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2504|TWO_SIDED|95.0|-7.02|1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.84|-7.02|0.2504
73924829|NCT00362115|147378262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0144|TWO_SIDED|95.0|-10.28|-1.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.14|-10.28|0.0144
73924830|NCT00362115|147378262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.0402|TWO_SIDED|95.0|-9.06|-0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.21|-9.06|0.0402
73924831|NCT00362115|147378263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2||||0.0014|TWO_SIDED|95.0|-8.41|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-8.41|0.0014
73924832|NCT00362115|147378263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||<|0.0001|TWO_SIDED|95.0|-10.82|-4.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.22|-10.82|< 0.0001
73924833|NCT00362115|147378263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2|||<|0.0001|TWO_SIDED|95.0|-11.51|-4.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.93|-11.51|< 0.0001
73924834|NCT00362115|147378263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|||<|0.0001|TWO_SIDED|95.0|-12.49|-5.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.72|-12.49|< 0.0001
73924835|NCT00362115|147378263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|||<|0.0001|TWO_SIDED|95.0|-10.87|-4.3||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.30|-10.87|< 0.0001
73924836|NCT00362115|147378263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.5519|TWO_SIDED|95.0|-2.11|3.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.95|-2.11|0.5519
73968386|NCT04176965|147474996|NON_INFERIORITY|Noninferiority of FINEVISION HP compared to control in percentages of first operative eyes with secondary surgical interventions related to the optical properties of the IOL was evaluated using two-sided 90% Farrington method confidence intervals around the difference in percentages between the 2 groups. If the upper limit of the confidence interval is less than 1.4%, the FINEVISION HP IOL will be considered statistically non-inferior to the control IOL.|Difference in percentages|0.3|||||TWO_SIDED|90.0|-0.76|1.36||||||||1.36|-0.76|
73968387|NCT04176965|147475001|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74087153|NCT02310763|147728276|SUPERIORITY||Mean Difference (Net)|-0.0934||||0.2294|TWO_SIDED|95.0|-0.2481|0.0613||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.0613|-0.2481|0.2294
74087154|NCT02310763|147728276|SUPERIORITY||Mean Difference (Net)|-0.0117||||0.8485|TWO_SIDED|95.0|-0.1339|0.1105||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.1105|-0.1339|0.8485
73924837|NCT00362115|147378263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3938|TWO_SIDED|95.0|-4.54|1.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.79|-4.54|0.3938
73924838|NCT00362115|147378263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1949|TWO_SIDED|95.0|-5.21|1.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.07|-5.21|0.1949
73924839|NCT00362115|147378263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0732|TWO_SIDED|95.0|-6.21|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.28|-6.21|0.0732
73924840|NCT00362115|147378263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3669|TWO_SIDED|95.0|-4.59|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.70|-4.59|0.3669
73924841|NCT00362115|147378264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2||||0.0019|TWO_SIDED|95.0|-14.94|-3.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.41|-14.94|0.0019
73924842|NCT00362115|147378264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.0008|TWO_SIDED|95.0|-16.15|-4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.26|-16.15|0.0008
73924843|NCT00362115|147378264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9||||0.004|TWO_SIDED|95.0|-14.88|-2.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.85|-14.88|0.0040
73968388|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Cystoid macular oedema. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
74087155|NCT02310763|147728276|SUPERIORITY||Mean Difference (Net)|0.0562||||0.6645|TWO_SIDED|95.0|-0.2187|0.3312||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.3312|-0.2187|0.6645
73968389|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Cystoid macular oedema. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968390|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Hypopyon. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
74087156|NCT02310763|147728277|SUPERIORITY||Mean Difference (Net)|-0.1013||||0.2101|TWO_SIDED|95.0|-0.2622|0.0597||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.0597|-0.2622|0.2101
74087157|NCT02310763|147728277|SUPERIORITY||Mean Difference (Net)|-0.0359||||0.4603|TWO_SIDED|95.0|-0.1326|0.0608||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.0608|-0.1326|0.4603
74087158|NCT02310763|147728277|SUPERIORITY||Mean Difference (Net)|0.1039||||0.3739|TWO_SIDED|95.0|-0.1386|0.3463||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.3463|-0.1386|0.3739
73924844|NCT00362115|147378264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6||||0.0001|TWO_SIDED|95.0|-18.96|-6.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.22|-18.96|0.0001
73924845|NCT00362115|147378264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.0004|TWO_SIDED|95.0|-16.85|-4.89||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.89|-16.85|0.0004
73924846|NCT00362115|147378264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.3499|TWO_SIDED|95.0|-8.39|2.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.98|-8.39|0.3499
73924847|NCT00362115|147378264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.2115|TWO_SIDED|95.0|-9.61|2.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.14|-9.61|0.2115
73924848|NCT00362115|147378264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.4279|TWO_SIDED|95.0|-8.34|3.54||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.54|-8.34|0.4279
73924849|NCT00362115|147378264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0566|TWO_SIDED|95.0|-12.41|0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.17|-12.41|0.0566
73924850|NCT00362115|147378264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1435|TWO_SIDED|95.0|-10.3|1.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.50|-10.30|0.1435
73924851|NCT00362115|147378265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.1162|TWO_SIDED|95.0|-6.16|0.68||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.68|-6.16|0.1162
73924852|NCT00362115|147378265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.2494|TWO_SIDED|95.0|-5.69|1.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.48|-5.69|0.2494
73924853|NCT00362115|147378265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.4247|TWO_SIDED|95.0|-5.01|2.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.12|-5.01|0.4247
73924854|NCT00362115|147378265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.3007|TWO_SIDED|95.0|-5.79|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.80|-5.79|0.3007
73924855|NCT00362115|147378265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.1195|TWO_SIDED|95.0|-6.67|0.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.77|-6.67|0.1195
73924856|NCT00362115|147378265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.2032|TWO_SIDED|95.0|-5.76|1.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.23|-5.76|0.2032
73924857|NCT00362115|147378265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3787|TWO_SIDED|95.0|-5.27|2.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.01|-5.27|0.3787
73924858|NCT00362115|147378265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.5967|TWO_SIDED|95.0|-4.59|2.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.64|-4.59|0.5967
73924859|NCT00362115|147378265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.4345|TWO_SIDED|95.0|-5.36|2.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.31|-5.36|0.4345
73924860|NCT00362115|147378265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.1954|TWO_SIDED|95.0|-6.24|1.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.28|-6.24|0.1954
73968391|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Hypopyon. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
74087159|NCT02310763|147728278|SUPERIORITY||Mean Difference (Net)|-0.3||||0.8925|TWO_SIDED|95.0|-4.5|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||3.9|-4.5|0.8925
73862268|NCT01443130|147270462|SUPERIORITY_OR_OTHER|||||||0.5187||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.5187
73862269|NCT01443130|147270462|SUPERIORITY_OR_OTHER|||||||0.2163||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.2163
73862270|NCT01443130|147270463|SUPERIORITY_OR_OTHER|||||||0.5959||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.5959
73862271|NCT01443130|147270463|SUPERIORITY_OR_OTHER|||||||0.8127||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.8127
73862272|NCT01443130|147270464|SUPERIORITY_OR_OTHER|||||||0.2566||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2566
73862273|NCT01443130|147270464|SUPERIORITY_OR_OTHER|||||||0.7839||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.7839
73924861|NCT03965962|147378266|NON_INFERIORITY|The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control group (Group 2) was greater than (\>) -5% at Day 28.|Difference in Percentage|-0.42|||||TWO_SIDED|95.0|-2.33|4.35||||||||4.35|-2.33|
73924862|NCT03965962|147378266|NON_INFERIORITY|The two-sided 95 % CI was calculated based on the Wilson score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control group (Group 3) was \> -5% at Day 28.|Difference in Percentage|0.86|||||TWO_SIDED|95.0|-1.32|6.5||||||||6.50|-1.32|
73924863|NCT00867451|147378278|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<.05
73924864|NCT01408030|147378286|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.97|||||||ANOVA|||||||0.97
73862274|NCT01443130|147270465|SUPERIORITY_OR_OTHER|||||||0.2553||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2553
73862275|NCT01443130|147270465|SUPERIORITY_OR_OTHER|||||||0.4354||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4354
73924865|NCT01408030|147378287|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.47|||||||ANOVA|||||||.47
73924866|NCT01408030|147378288|OTHER|Two sided testing was performed with a significance level of 0.05.|||||<|0.001||||||"A mixed-model repeated-measures ANOVA was used to analyze ESS for drug and time (baseline, week 12) effects.~Listed P value is for time effect."|Mixed Models Analysis|Clinical site and patient were included in the model as random effects.||||||<0.001
73924867|NCT01408030|147378289|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.43|||||||ANCOVA|Adjusted for baseline values and random effect of clinic site.||||||0.43
73924868|NCT01408030|147378290|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.42|||||||Fisher Exact|||||||0.42
73924869|NCT01408030|147378291|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.08|||||||Fisher Exact|||||||0.08
73924870|NCT00729183|147378292|SUPERIORITY_OR_OTHER||Difference in LS Means|3.49|||<|0.001|TWO_SIDED|95.0|2.66|4.32|||Longitudinal Data Analysis (LDA) Model|||A longitudinal ANCOVA was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% confidence interval (CI). The model, applied on all time points during treatment (Screening Visit \[BL\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted Least Squares (LS) mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.||4.32|2.66|<0.001
73924871|NCT00729183|147378293|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.2|||||TWO_SIDED|95.0|-12.3|7.9||||||Estimated difference (versus Placebo) and CI were based on the Miettinen \& Nurminen method.||7.9|-12.3|
73924872|NCT00729183|147378294|SUPERIORITY_OR_OTHER||Difference in Percentage|4.4|||||TWO_SIDED|95.0|-3.2|12.3||||||Estimated difference (versus Placebo) and CI were based on the Miettinen \& Nurminen method.||12.3|-3.2|
73968392|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Endophthalmitis. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73862276|NCT01443130|147270466|SUPERIORITY_OR_OTHER|||||||0.369||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.3690
73924873|NCT00729183|147378295|SUPERIORITY_OR_OTHER||Difference in LS Means|5.39|||<|0.001|TWO_SIDED|95.0|4.36|6.42|||LDA|||A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted LS mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.||6.42|4.36|<0.001
73924874|NCT00729183|147378296|SUPERIORITY_OR_OTHER||Difference in LS Means|1.57|||<|0.001|TWO_SIDED|95.0|0.88|2.25|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.25|0.88|<0.001
73924875|NCT00729183|147378296|SUPERIORITY_OR_OTHER||Difference in LS Means|3.32|||<|0.001|TWO_SIDED|95.0|2.39|4.26|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||4.26|2.39|<0.001
73924876|NCT00729183|147378297|SUPERIORITY_OR_OTHER||Difference in LS Means|1.48||||0.001|TWO_SIDED|95.0|0.6|2.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.35|0.60|0.001
73924877|NCT00729183|147378297|SUPERIORITY_OR_OTHER||Difference in LS Means|3.81|||<|0.001|TWO_SIDED|95.0|2.69|4.93|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||4.93|2.69|<0.001
73968393|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Endophthalmitis. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968394|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968395|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73924878|NCT00729183|147378298|SUPERIORITY_OR_OTHER||Difference in LS Means|2.19|||<|0.001|TWO_SIDED|95.0|1.09|3.29|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||3.29|1.09|<0.001
73968396|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Pupillary block.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968397|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Pupillary block.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73862277|NCT01443130|147270466|SUPERIORITY_OR_OTHER|||||||0.4947||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4947
73862278|NCT01443130|147270467|SUPERIORITY_OR_OTHER|||||||0.063||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.0630
73924879|NCT00729183|147378298|SUPERIORITY_OR_OTHER||Difference in LS Means|5.48|||<|0.001|TWO_SIDED|95.0|4.08|6.89|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||6.89|4.08|<0.001
73924880|NCT00729183|147378299|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.03|TWO_SIDED|95.0|0.07|1.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||1.35|0.07|0.030
73924881|NCT00729183|147378299|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7|||<|0.001|TWO_SIDED|95.0|0.97|2.43|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||2.43|0.97|<0.001
73924882|NCT00729183|147378300|SUPERIORITY_OR_OTHER||Difference in LS Means|1.71||||0.001|TWO_SIDED|95.0|0.69|2.73|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.73|0.69|0.001
73924883|NCT00729183|147378300|SUPERIORITY_OR_OTHER||Difference in LS Means|2.7|||<|0.001|TWO_SIDED|95.0|1.62|3.78|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||3.78|1.62|<0.001
73924884|NCT00729183|147378301|SUPERIORITY_OR_OTHER||Difference in LS Means|0.16||||0.697|TWO_SIDED|95.0|-0.63|0.95|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||0.95|-0.63|0.697
74028719|NCT01096667|147611186|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.84||||0.01|TWO_SIDED|80.0|-5.95|-1.73||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.73|-5.95|0.010
73862279|NCT01443130|147270467|SUPERIORITY_OR_OTHER|||||||0.4184||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4184
73862280|NCT01443130|147270468|SUPERIORITY_OR_OTHER|||||||0.0268||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.0268
73924885|NCT00729183|147378301|SUPERIORITY_OR_OTHER||Difference in LS Means|1.22||||0.013|TWO_SIDED|95.0|0.27|2.18|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||2.18|0.27|0.013
73924886|NCT00729183|147378302|SUPERIORITY_OR_OTHER||Difference in LS Means|8.01|||<|0.001|TWO_SIDED|95.0|6.03|9.99|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||9.99|6.03|<0.001
73924887|NCT00729183|147378302|SUPERIORITY_OR_OTHER||Difference in LS Means|11.46|||<|0.001|TWO_SIDED|95.0|8.96|13.97|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||13.97|8.96|<0.001
73924888|NCT00729183|147378303|SUPERIORITY_OR_OTHER||Difference in LS Means|5.68|||<|0.001|TWO_SIDED|95.0|3.77|7.58|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||7.58|3.77|<0.001
73924889|NCT00729183|147378303|SUPERIORITY_OR_OTHER||Difference in LS Means|9.38|||<|0.001|TWO_SIDED|95.0|6.98|11.77|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||11.77|6.98|<0.001
73924890|NCT00729183|147378304|SUPERIORITY_OR_OTHER||Difference in LS Means|-54.03|||<|0.001|TWO_SIDED|95.0|-64.81|-43.26|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||-43.26|-64.81|<0.001
73924891|NCT00729183|147378304|SUPERIORITY_OR_OTHER||Difference in LS Means|-45.59|||<|0.001|TWO_SIDED|95.0|-62.22|-28.96|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||-28.96|-62.22|<0.001
73924892|NCT00729183|147378305|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.34|||<|0.001|TWO_SIDED|95.0|-37.77|-12.92|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo.||-12.92|-37.77|<0.001
73924893|NCT00729183|147378305|SUPERIORITY_OR_OTHER||Difference in LS Means|-9.07||||0.225|TWO_SIDED|95.0|-23.69|5.56|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo.||5.56|-23.69|0.225
73968398|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Retinal detachment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968399|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Retinal detachment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968400|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Secondary surgical intervention.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968401|NCT04176965|147475002|NON_INFERIORITY|Cumulative: Secondary surgical intervention.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968402|NCT04176965|147475002|NON_INFERIORITY|Persistent: Corneal stroma oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968403|NCT04176965|147475002|NON_INFERIORITY|Persistent: Corneal stroma oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
74028720|NCT01096667|147611186|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.33||||0.02|TWO_SIDED|80.0|-5.4|-1.25||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.25|-5.40|0.020
74028721|NCT01096667|147611188|SUPERIORITY_OR_OTHER||Difference in least squares means|42.18||||0|TWO_SIDED|80.0|31.42|52.94||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||52.94|31.42|0.000
74028722|NCT01096667|147611188|SUPERIORITY_OR_OTHER||Difference in least squares means|60.39||||0|TWO_SIDED|80.0|49.47|71.31||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||71.31|49.47|0.000
73924894|NCT02867709|147378306|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0285|TWO_SIDED|95.0|1.09|2.22||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.22|1.09|0.0285
73924895|NCT02867709|147378306|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0129|TWO_SIDED|95.0|1.14|2.29||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.29|1.14|0.0129
73924896|NCT02867709|147378307|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0711|TWO_SIDED|95.0|1.02|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||1.83|1.02|0.0711
73924897|NCT02867709|147378307|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0129|TWO_SIDED|95.0|1.25|2.2||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.20|1.25|0.0129
73924898|NCT02867709|147378308|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0711|TWO_SIDED|95.0|1.25|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.17|1.25|0.0711
73968404|NCT04176965|147475002|NON_INFERIORITY|Persistent: Cystoid macular oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968405|NCT04176965|147475002|NON_INFERIORITY|Persistent: Cystoid macular oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968406|NCT04176965|147475002|NON_INFERIORITY|Persistent: Iritis.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968407|NCT04176965|147475002|NON_INFERIORITY|Persistent: Iritis.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968408|NCT04176965|147475002|NON_INFERIORITY|Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968409|NCT04176965|147475002|NON_INFERIORITY|Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
73968410|NCT04072380|147475017|SUPERIORITY|||||||0.024||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.024
73968411|NCT04072380|147475018|SUPERIORITY|||||||0.009||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.009
73968412|NCT04072380|147475019|SUPERIORITY|||||||0.734||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.734
73968413|NCT04072380|147475020|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73968414|NCT04072380|147475021|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73968415|NCT03033576|147475035|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.04|TWO_SIDED|90.0|0.41|0.97||Pre-specified one-sided alpha=0.1|Log Rank|||The statistical design assumed exponential PFS with a median of 3.0 months on the ipilimumab group (null hypothesis). The study was powered to detect a change in median PFS to 6.0 months in the combination therapy group (corresponding to an HR of 0.50). A total of 84 participants (63 randomized to combination group and 21 to ipilimumab group) with 78 events (across both groups) would provide 89% power for a one-sided alpha of 10% using a log-rank test.||0.97|0.41|0.04
73968416|NCT03033576|147475038|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.28|TWO_SIDED|90.0|0.5|1.39|||Log Rank|||||1.39|0.50|0.28
73968417|NCT01606215|147475102|OTHER|||||||0.84|||||||t-test, 2 sided|||Week 4 data||||0.84
73968418|NCT01606215|147475102|OTHER|||||||0.62|||||||t-test, 2 sided|||Week 12 data||||0.62
73968419|NCT01606215|147475102|OTHER|||||||0.61|||||||t-test, 2 sided|||Week 24 data||||0.61
73968420|NCT01606215|147475105|OTHER|||||||0.77|||||||t-test, 2 sided|||Week 4||||0.77
73924899|NCT02867709|147378308|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0129|TWO_SIDED|95.0|1.35|2.32||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.32|1.35|0.0129
73968421|NCT01606215|147475105|OTHER|||||||0.68|||||||t-test, 2 sided|||Week 12||||0.68
73968422|NCT01606215|147475105|OTHER|Week 24||||||0.48|||||||t-test, 2 sided|||Week 24||||0.48
73968423|NCT04709783|147475143|OTHER|One group pre-post test.|Median Difference (Final Values)|-2.67||||0.01|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.01
73968424|NCT04709783|147475144|OTHER||Median Difference (Final Values)|-2.49||||0.01|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
73968425|NCT04709783|147475145|OTHER||Median Difference (Final Values)|-1.84||||0.07|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.07
73968426|NCT04709783|147475146|OTHER||Median Difference (Final Values)|-2.37||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
73924900|NCT02867709|147378309|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0711|TWO_SIDED|95.0|1.33|2.48||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.48|1.33|0.0711
73924901|NCT02867709|147378309|SUPERIORITY||Odds Ratio (OR)|2.16||||0.0129|TWO_SIDED|95.0|1.59|2.92||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.92|1.59|0.0129
73924902|NCT02867709|147378310|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0711|TWO_SIDED|95.0|1.04|2.53||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.53|1.04|0.0711
73924903|NCT02867709|147378310|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0129|TWO_SIDED|95.0|1.2|2.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.83|1.20|0.0129
73924904|NCT02867709|147378311|SUPERIORITY||Odds Ratio (OR)|1.28||||0.1833|TWO_SIDED|95.0|0.96|1.72||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||1.72|0.96|0.1833
73924905|NCT02867709|147378311|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0167|TWO_SIDED|95.0|1.14|2.02||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.02|1.14|0.0167
73968427|NCT04648033|147475168|OTHER||Probability of DLT at dose level 4|0.116|||||TWO_SIDED|95.0|0.032|0.26||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE-CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.26|0.032|
73968428|NCT03131648|147475176|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|8.6||||0.002|TWO_SIDED|95.0|4.1|13.1||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||13.1|4.1|0.002
73968429|NCT03131648|147475177|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|12.1|||<|0.001|TWO_SIDED|95.0|6.5|17.7||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||17.7|6.5|<0.001
73968430|NCT03131648|147475178|SUPERIORITY||Risk Difference (RD)|9.7||||0.002|TWO_SIDED|95.0|4.4|15.0||Based on the primary analysis of the primary estimand 'Composite', subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.|Cochran-Mantel-Haenszel|Tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Reduction of Worst Daily Pruritus NRS weekly average ≥4 at Week 16 was tested after the sequential testing of IGA 0/1 and EASI75 if these tests showed statistical significance.||15|4.4|0.002
74028723|NCT01096667|147611188|SUPERIORITY_OR_OTHER||Difference in least squares means|70.34||||0|TWO_SIDED|80.0|59.58|81.1||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||81.10|59.58|0.000
74028724|NCT01096667|147611188|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.63||||0.713|TWO_SIDED|80.0|-15.22|5.96||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||5.96|-15.22|0.713
74028725|NCT01096667|147611190|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.1||||0.007|TWO_SIDED|80.0|-27.45|-8.75||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-8.75|-27.45|0.007
74028726|NCT01096667|147611190|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.81||||0|TWO_SIDED|80.0|-44.19|-25.43||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-25.43|-44.19|0.000
74087160|NCT02310763|147728278|SUPERIORITY||Mean Difference (Net)|1.2||||0.2107|TWO_SIDED|95.0|-0.7|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.2|-0.7|0.2107
74028727|NCT01096667|147611190|SUPERIORITY_OR_OTHER||Difference in least squares means|-35.42||||0|TWO_SIDED|80.0|-44.78|-26.07||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-26.07|-44.78|0.000
74087161|NCT02310763|147728278|SUPERIORITY||Mean Difference (Net)|1.3||||0.2298|TWO_SIDED|95.0|-0.9|3.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.5|-0.9|0.2298
73924906|NCT02867709|147378312|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1066|TWO_SIDED|95.0|1.04|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.83|1.04|0.1066
73924907|NCT02867709|147378312|SUPERIORITY||Odds Ratio (OR)|1.39||||0.044|TWO_SIDED|95.0|1.05|1.84||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.84|1.05|0.0440
73924908|NCT02867709|147378313|SUPERIORITY||Odds Ratio (OR)|1.1||||0.9522|TWO_SIDED|95.0|0.81|1.49||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.49|0.81|0.9522
73924909|NCT02867709|147378313|SUPERIORITY||Odds Ratio (OR)|1.12||||0.9522|TWO_SIDED|95.0|0.83|1.51||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.51|0.83|0.9522
73924910|NCT05497284|147378314|OTHER|Probability (LTP001 is better than placebo)|Slope|-2.6|STANDARD_DEVIATION|2.07|||TWO_SIDED|80.0|-6.9|1.3||Probability that LTP001 is better than placebo is 10.3%|Baysesian random slope model|Bayesian random slope model to assess the difference in reduction rate (slope) in years between the treatment group and placebo group.||||1.3|-6.9|
73924911|NCT03878446|147378324|SUPERIORITY||Treatment difference|-1.4|||||TWO_SIDED|95.0|-3.2|0.4||||||||0.4|-3.2|
73924912|NCT03878446|147378324|SUPERIORITY||Treatment difference|0.7|||||TWO_SIDED|95.0|-1.1|2.5||||||||2.5|-1.1|
73924913|NCT03878446|147378324|SUPERIORITY||Treatment difference|-0.9|||||TWO_SIDED|95.0|-2.6|0.9||||||||0.9|-2.6|
73924914|NCT03878446|147378324|SUPERIORITY||Treatment difference|-0.6|||||TWO_SIDED|95.0|-2.4|1.2||||||||1.2|-2.4|
73924915|NCT05214768|147378334|SUPERIORITY||Least Square Mean Difference|-223.2|STANDARD_ERROR_OF_MEAN|74.98||0.003|TWO_SIDED|95.0|-370.2|-76.3|||ANCOVA|||||-76.3|-370.2|0.003
73924916|NCT00567892|147378372|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.944|TWO_SIDED|95.0|-6.0|4.0||All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|Wilcoxon signed rank test|Since the assumptions of parametric tests were not met we used non-parametric tests for the analysis.||The null hypothesis for this study was the difference between the change in THI score due to active rTMS treatment and the change in THI score due to rTMS sham was not different from 0.||4|-6|0.944
73924917|NCT00567892|147378372|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0||||0.674|TWO_SIDED|95.0|-9.0|10.0|||Wilcoxon signed rank test|The assumptions of parametric tests were not met.|All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|The null hypothesis for this study was the difference between the change in THI score due to 4 weeks active rTMS treatment and the change in THI score due to 4 weeks rTMS sham was not different from 0.||10|-9|0.674
73968431|NCT03131648|147475179|SUPERIORITY|Multiplicity adjustment using the Holm method.|Difference of least square means|-10.4|||<|0.001|TWO_SIDED|95.0|-14.4|-6.5||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or after initiation of rescue medication were not included in the analysis.||-6.5|-14.4|<0.001
74028728|NCT01096667|147611190|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.61||||0.467|TWO_SIDED|80.0|-9.86|8.65||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||8.65|-9.86|0.467
73924918|NCT03265249|147378404|SUPERIORITY||Median Difference (Final Values)|5.7||||0.8|TWO_SIDED|95.0|-17.5|29.0|||Mixed Models Analysis|||||29|-17.5|0.80
73968432|NCT03131648|147475180|SUPERIORITY|Multiplicity adjustment using Holm method.|Difference of least square means|-2.1||||0.002|TWO_SIDED|95.0|-3.4|-0.8||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-0.8|-3.4|0.002
74028729|NCT01096667|147611191|SUPERIORITY_OR_OTHER||Difference in least squares means|-5.54||||0.224|TWO_SIDED|80.0|-14.89|3.82||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||3.82|-14.89|0.224
74028730|NCT01096667|147611191|SUPERIORITY_OR_OTHER||Difference in least squares means|-17.0||||0.011|TWO_SIDED|80.0|-26.39|-7.61||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-7.61|-26.39|0.011
73924919|NCT00706641|147378482|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||paired t-test|||Tumor samples from 20 patients were analyzed for expression of pSFK. A paired t-Test was used to calculate the significance of the difference in expression levels before and after treatment.||||0.003
74028731|NCT01096667|147611191|SUPERIORITY_OR_OTHER||Difference in least squares means|-26.59||||0|TWO_SIDED|80.0|-35.84|-17.33||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-17.33|-35.84|0.000
73924920|NCT00706641|147378485|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||paired t-test|||||||0.20
73924921|NCT00706641|147378486|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||paired t-test|||||||0.42
73924922|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.109|1.535||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95.||1.535|0.109|
73924923|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.43|3.282||||||Univariate Cox regression: Hazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker IGF1R.||3.282|0.430|
73924924|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.306|2.425||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker c-MET.||2.425|0.306|
73924925|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.164|1.453||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: \<median / ≥median) for the biomarker PTEN.||1.453|0.164|
73924926|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.377|3.16||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker HER2.||3.160|0.377|
73924927|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.409|4.132||||||Univariate Cox regression Hazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.||4.132|0.409|
73924928|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.183|||||TWO_SIDED|95.0|0.226|6.197||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||6.197|0.226|
73924929|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.989|||||TWO_SIDED|95.0|0.378|10.47||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||10.470|0.378|
73924930|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.732|||||TWO_SIDED|95.0|0.235|12.783||||||Univariate Cox regression Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||12.783|0.235|
73924931|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.||4.968|0.067|
73924932|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.743|||||TWO_SIDED|95.0|0.082|6.72||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.||6.720|0.082|
73924933|NCT00885755|147378619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073|||||TWO_SIDED|95.0|0.274|4.199||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.||4.199|0.274|
73924934|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.12|1.79||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95 HER2.||1.790|0.120|
73924935|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.394|3.518||||||Univariate Cox regressionHazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker IGF1R.||3.518|0.394|
73968433|NCT03131648|147475181|SUPERIORITY||Risk Difference (RD)|6.0||||0.68|TWO_SIDED|95.0|-21.8|33.7||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.~P value was considered non-significant."|Cochran-Mantel-Haenszel|This test was not statistically significant and hence next maintenance endpoint in the sequential testing procedure was not evaluated.|Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||33.7|-21.8|0.68
73968434|NCT03131648|147475181|SUPERIORITY||Risk Difference (RD)|-9.5||||0.5|TWO_SIDED|95.0|-37.1|18.0||Test not evaluated for significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||18.0|-37.1|0.50
73924936|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.268|2.514||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker c-met.||2.514|0.268|
73924937|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.183|1.768||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: \< median / ≥median) for the marker PTEN.||1.768|0.183|
73924938|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.242|2.733||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker HER2.||2.733|0.242|
73968435|NCT03131648|147475182|SUPERIORITY||Risk Difference (RD)|21.2||||0.056|TWO_SIDED|95.0|-0.2|42.6||Test not evaluated for significance. Based on the primary analysis of the primary estimand 'composite'. Subjects who received rescue medication or were transferred to open-label treatment are considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||42.6|-0.2|0.056
73924939|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.337|3.632||||||Univariate Cox regressionHazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.||3.632|0.337|
73924940|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.957|||||TWO_SIDED|95.0|0.172|5.336||||||Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||5.336|0.172|
73924941|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.666|||||TWO_SIDED|95.0|0.298|9.305||||||Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||9.305|0.298|
73924942|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.732|||||TWO_SIDED|95.0|0.235|12.783||||||Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||12.783|0.235|
73924943|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.||4.968|0.067|
73924944|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.956|||||TWO_SIDED|95.0|0.098|9.319||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.||9.319|0.098|
73924945|NCT00885755|147378622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.292|||||TWO_SIDED|95.0|0.296|5.64||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.||5.640|0.296|
73924946|NCT00885755|147378630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.03|||||TWO_SIDED|95.0|0.001|0.641||||||Univariate logistic regression Odds ratio (Positive / Negative) for the biomarker p95 HER 2.||0.641|0.001|
73924947|NCT00885755|147378630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.208|||||TWO_SIDED|95.0|0.017|2.6||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /\<median) for the biomarker IGF1R.||2.600|0.017|
73924948|NCT00885755|147378630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.143|||||TWO_SIDED|95.0|0.169|27.103||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥ median /\<median) for the biomarker c-MET.||27.103|0.169|
73924949|NCT00885755|147378630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.875|||||TWO_SIDED|95.0|0.15|23.396||||||Univariate logistic regression Odds ratio (Cytoplasm H-Score: ≥ median /\< median) for the biomarker PTEN.||23.396|0.150|
73924950|NCT00885755|147378630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.857|||||TWO_SIDED|95.0|0.091|8.075||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /\< median) for the biomarker HER2.||8.075|0.091|
73924951|NCT00885755|147378630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.148|||||TWO_SIDED|95.0|0.012|1.9||||||Univariate logistic regression Odds ratio (PI3K mutation status: WT versus M) for the biomarker PI3K Amino Acids.||1.900|0.012|
73924952|NCT00885755|147378630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.053|18.915||||||Univariate logistic regressionOdds ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||18.915|0.053|
73924953|NCT00885755|147378630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.083|||||TWO_SIDED|95.0|0.004|1.945||||||Univariate logistic regression Odds ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H||1.945|0.004|
73924954|NCT01817725|147378653|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73924955|NCT01549964|147378671|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.108|<|0.001|TWO_SIDED|95.0|-0.77|-0.34||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.34|-0.77|<0.001
73924956|NCT01549964|147378671|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|0.15|0.49||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||0.49|0.15|<0.001
73924957|NCT01549964|147378671|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-1.03|-0.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.60|-1.03|<0.001
73924958|NCT01549964|147378671|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.524|TWO_SIDED|95.0|-0.12|0.23||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||0.23|-0.12|0.524
73924959|NCT01549964|147378672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.05|TWO_SIDED|95.0|1.0|5.08||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||5.08|1.00|0.050
73924960|NCT01549964|147378672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.23|0.67||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||0.67|0.23|<0.001
73924961|NCT01549964|147378672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.06|||<|0.001|TWO_SIDED|95.0|2.24|11.42||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||11.42|2.24|<0.001
73968436|NCT03131648|147475182|SUPERIORITY||Risk Difference (RD)|11.7||||0.27|TWO_SIDED|95.0|-8.7|32.0||Test not evaluated for significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||32.0|-8.7|0.27
73968437|NCT03131648|147475185|SUPERIORITY|"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Risk Difference (RD)|20.1|||<|0.001|TWO_SIDED|95.0|13.3|26.8|||Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||26.8|13.3|<0.001
74028732|NCT01096667|147611191|SUPERIORITY_OR_OTHER||Difference in least squares means|8.65||||0.886|TWO_SIDED|80.0|-0.56|17.87||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||17.87|-0.56|0.886
74028733|NCT00465738|147611209|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Newcombe-Wilson confidence interval for the difference between the response rates of the groups was calculated. The lower bound of the Newcombe-Wilson CI for the difference of proportions was compared to the non-inferiority margin of -25%.|difference in response rates|10.6|||||TWO_SIDED|95.0|-4.4|24.9|||||difference in response rates = response rate for high volume dilution group (20 U/ml) - response rate for low volume dilution group (50 U/ml)|Null hypothesis: The response rate for the low volume dilution group (50 U/ml) is greater than the response rate for the high volume dilution group (20 U/ml).||24.9|-4.4|
73924962|NCT01549964|147378672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.493|TWO_SIDED|95.0|0.5|1.39||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||1.39|0.50|0.493
73924963|NCT01549964|147378673|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-33.8|-16.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-16.6|-33.8|<0.001
73924964|NCT01549964|147378673|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|3.49||0.142|TWO_SIDED|95.0|-12.0|1.7||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||1.7|-12.0|0.142
73924965|NCT01549964|147378673|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-39.9|-22.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-22.6|-39.9|<0.001
74028734|NCT00515463|147611260|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7|||||Risk difference \> 0 indicates that incidence of binding anti-denosumab antibodies in denosumab PFS is greater than denosumab vial. 95% CI based on a normal approximation with continuity correction.|||0.7|-0.7|
74028735|NCT00515463|147611261|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7||||||||0.7|-0.7|
74028736|NCT01591018|147611354|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||Pre-study calculations using chi-square test with a continuity correction showed that ≥60 patients in each group were needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8.|Chi-squared, Corrected|||Sample size was based on an expected 20% reduction of new ischemic lesions on DW-MRI in the sonolysis group (estimated prevalence, 10%) compared with the control group (estimated prevalence, 30%).||||<0.05
74028737|NCT03136705|147611357|SUPERIORITY||trend analysis|1.009||||0.3738|TWO_SIDED|95.0|0.989|1.031|||Mixed Models Analysis|||linear mixed model for repeated measures data||1.031|0.989|0.3738
74028738|NCT03136705|147611358|SUPERIORITY||trend analysis|0.0043||||0.854|TWO_SIDED|95.0|-0.0414|0.0499|||Mixed Models Analysis|||linear mixed model for repeated measures data||0.0499|-0.0414|0.854
74028739|NCT03136705|147611359|SUPERIORITY||trend analysis|20.38||||0.0648|TWO_SIDED|95.0|-1.26|42.03|||Mixed Models Analysis|||linear mixed model for repeated measures data||42.03|-1.26|0.0648
74028740|NCT04655586|147611362|SUPERIORITY|||||||0.4715||||||All rNAPc2 vs. Heparin|Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.4715
74028741|NCT04655586|147611363|SUPERIORITY|||||||0.1883|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.1883
74028742|NCT04655586|147611366|SUPERIORITY|||||||1|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||1.0
74028743|NCT04655586|147611367|SUPERIORITY|||||||0.0254|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.0254
73862281|NCT01443130|147270468|SUPERIORITY_OR_OTHER|||||||0.1646||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1646
74028744|NCT04655586|147611368|SUPERIORITY|||||||0.0535|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.0535
74028745|NCT04655586|147611369|SUPERIORITY|||||||0.83|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.8300
74028746|NCT02927171|147611385|OTHER|||||||0.17|||||||t-test, 1 sided|||||||0.17
74028747|NCT02677701|147611389|SUPERIORITY||Mean Difference (Net)|3.44||||0.0846|TWO_SIDED|95.0|-0.48|7.35|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||7.35|-0.48|0.0846
74028748|NCT02677701|147611390|SUPERIORITY||Mean Difference (Net)|1.31||||0.51|TWO_SIDED|95.0|-2.64|5.26|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||5.26|-2.64|0.51
74028749|NCT02677701|147611391|SUPERIORITY||Mean Difference (Net)|-2.89||||0.17|TWO_SIDED|95.0|-7.01|1.22|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||1.22|-7.01|0.17
74028750|NCT02677701|147611392|SUPERIORITY||Mean Difference (Net)|1.53||||0.56|TWO_SIDED|95.0|-3.7|6.77||Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).|Regression, Linear|||||6.77|-3.70|0.56
74028751|NCT02677701|147611393|SUPERIORITY||Mean Difference (Net)|0.75||||0.043|TWO_SIDED|95.0|0.03|1.47||Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).|Regression, Linear|||||1.47|0.03|0.043
74028752|NCT03494725|147611451|SUPERIORITY|||||||0.757||||||Outcome was subjected to transformation to meet model assumptions. The threshold for statistical significance was p=0.05.|Mixed Models Analysis|Linear mixed model||The sample size was computed for a repeated measurement ANOVA with two groups and seven repeated measurements (power=0.85, α=0.05, f=0.1). The calculation resulted in a group size of 56 participants each, which was rounded up to 60 participants per treatment group to account for attrition.||||0.757
74028753|NCT04083144|147611485|SUPERIORITY||η2|0.01||||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
74028754|NCT04083144|147611486|SUPERIORITY||η2|0.16||||0.76|TWO_SIDED||||||Mixed Models Analysis|||||||0.76
74028755|NCT04083144|147611487|SUPERIORITY||η2|0.02||||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
74028756|NCT04083144|147611488|SUPERIORITY||η2|0.07||||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
74028757|NCT04083144|147611489|SUPERIORITY||η2|0.17||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
74028758|NCT00149825|147611497|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Chi-squared|This is a one-tailed test||We hypothesized that compared with MED+CTRL, a greater percent of participants randomized to MED+CBTI will experience remission of depression||||.13
74028759|NCT00149825|147611498|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||We hypothesized that compared with MED+CTRL, a greater percent of participants in MED+CBTI will experience remission of insomnia.||||.05
74028760|NCT03694522|147611508|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0727|TWO_SIDED|95.0|0.44|1.04|||Stratified log-rank test|Adjusted for randomization stratification factors of geographic region and administration of mFOLFOX6 single dose prior to randomization.|Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||1.04|0.44|0.0727
74028761|NCT03694522|147611509|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0268|TWO_SIDED|95.0|0.35|0.95|||Stratified log-rank test|Adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||0.95|0.35|0.0268
73924966|NCT01549964|147378673|SUPERIORITY_OR_OTHER||Least Square Mean difference|-11.2|STANDARD_ERROR_OF_MEAN|3.53||0.002|TWO_SIDED|95.0|-18.1|-4.2||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-4.2|-18.1|0.002
73924967|NCT02449174|147378675|SUPERIORITY|||||||0.8958|||||||Chi-squared, Corrected|||||||0.8958
73924968|NCT02449174|147378676|SUPERIORITY|||||||0.2059|||||||Chi-squared, Corrected|||||||0.2059
73924969|NCT01272830|147378677|SUPERIORITY|||||||0.0063||||||Significance threshold p\<0.05|paired t-test|||Change from baseline data.||||0.0063
73924970|NCT01272830|147378677|SUPERIORITY||||||>|0.05||||||Significant threshold p\<0.05|paired t-test|||Changes from baseline data||||>0.05
73924971|NCT01272830|147378678|SUPERIORITY|||||||0.0226||||||Significance threshold p\<0.5|paired|||Change from baseline data (HSS pain walking)||||0.0226
73924972|NCT01272830|147378678|SUPERIORITY|||||||0.0375||||||Significance threshold P\<0.05|paired t-test|||Change from baseline data (HSS total score)||||0.0375
73924973|NCT01272830|147378678|SUPERIORITY|||||||0.0391||||||Significance threshold p\<0.05|paired t-test|||Change from baseline data (KSS knee pain)||||0.0391
73924974|NCT01272830|147378678|SUPERIORITY|||||||0.2137|||||||paired t-test|||Changes from baseline data (HSS pain walking)||||0.2137
73968438|NCT03131648|147475186|SUPERIORITY||Risk Difference (RD)|10.3|||<|0.001|TWO_SIDED|95.0|6.4|14.1||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||14.1|6.4|<0.001
74028762|NCT03694522|147611510|SUPERIORITY||Difference|13.1||||0.106|TWO_SIDED|95.0|-2.8|29.0|||Cochran-Mantel-Haenszel|P-value was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions||||29.0|-2.8|0.1060
73924975|NCT01272830|147378678|SUPERIORITY|||||||0.1312|||||||paired t-test|||Change from baseline data (HSS total score)||||0.1312
73924976|NCT01272830|147378678|SUPERIORITY|||||||0.1578|||||||paired t-test|||Change from baseline data (KSS knee pain)||||0.1578
73924977|NCT01272830|147378679|SUPERIORITY|||||||0.0083||||||Significance threshold p\<0.05|t-test|||Changes from baseline data||||0.0083
73924978|NCT01272830|147378679|SUPERIORITY||||||>|0.05||||||Significant threshold p\<0.05|paired t-test|||Change from baseline data||||>0.05
74028763|NCT03694522|147611512|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.38|0.94|||||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||0.94|0.38|
74087162|NCT02310763|147728279|SUPERIORITY||Mean Difference (Net)|3.5||||0.0554|TWO_SIDED|95.0|-0.1|7.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||7.1|-0.1|0.0554
73924979|NCT01272830|147378680|SUPERIORITY|||||||0.01||||||Significance threshold p\<0.05|ANOVA|||Change from baseline data||||0.01
73924980|NCT01272830|147378680|SUPERIORITY||||||>|0.05|||||||paired t-test|Significant threshold p\<0.05||Changes from baseline data||||>0.05
73924981|NCT00751348|147378681|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-measles was above -10%.|Difference in percentage|-1.36|||<|0.05|TWO_SIDED|95.0|-3.77|1.66||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-measles seroconversion rates.||1.66|-3.77|<0.05
73924982|NCT00751348|147378681|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-mumps was above -10%.|Difference in percentage|-5.34|||<|0.05|TWO_SIDED|95.0|-10.4|0.38||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-mumps seroconversion rates.||0.38|-10.4|<0.05
73924983|NCT00751348|147378681|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-rubella was above -10%.|Difference in percentage|-0.34|||<|0.05|TWO_SIDED|95.0|-1.88|2.06||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-rubella seroconversion rates.||2.06|-1.88|<0.05
73924984|NCT00751348|147378681|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-VZV was above -10%.|Difference in percentage|-1.06|||<|0.05|TWO_SIDED|95.0|-3.07|1.44||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-varicella zoster virus (anti-VZV) seroconversion rates.||1.44|-3.07|<0.05
73924985|NCT02039674|147378694|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|26.3||||0.0016|TWO_SIDED|95.0|8.9|42.1|||Miettinen & Nurminen Method|||||42.1|8.9|0.0016
73924986|NCT02039674|147378695|SUPERIORITY|||||||0.0858|||||||Exact binomial distribution for testing|HO: ORR ≤20% versus H1: ORR \>20%||||||0.0858
73924987|NCT02039674|147378697|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54||||0.00252|TWO_SIDED|95.0|0.35|0.83|||Log Rank|One-sided p-value based on log-rank test||||0.83|0.35|0.00252
74087163|NCT02310763|147728279|SUPERIORITY||Mean Difference (Net)|1.6||||0.2027|TWO_SIDED|95.0|-0.9|4.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||4.0|-0.9|0.2027
73924988|NCT02039674|147378698|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.06762|TWO_SIDED|95.0|0.45|1.12|||Log Rank|One-sided p-value based on log-rank test||||1.12|0.45|0.06762
73924989|NCT01358357|147378700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.078|TWO_SIDED|95.0|0.49|1.04||A hazard ratio of time to recurrence and its corresponding 95% Wald CI were estimated for the lurasidone arm vs.placebo arm, using a Cox proportional hazards model.Cox model included treatment effect as fixed effect, and stratified by pooled country.|Cox Proportional Hazards Model|||It was assumed that the recurrence event rates during the double-blind phase were to be 24% and 39% for subjects treated with lurasidone and placebo, respectively. A total of 120 recurrence events were required to achieve 90% power to detect the 15% difference in subjects who had a recurrence event during the double-blind phase between the treatment groups using a log-rank test with two sided alpha level of 0.05.||1.04|0.49|<0.078
73924990|NCT01358357|147378701|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72|||<|0.034|TWO_SIDED|95.0|0.54|0.98||A HR of time to discontinuation and corresponding 95% Wald CI were est. for lurasidone arm vs.the placebo arm, using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect,stratified by pooled country.|Cox Proportional Hazards Model|||||0.98|0.54|<0.034
73924991|NCT01358357|147378702|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72||||0.113|TWO_SIDED|95.0|0.48|1.08||A HR of time to recurrence and its corresponding 95% Wald CI were estimated for lurasidone arm vs. placebo arm,using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect stratified by pooled country.|Cox Proportional hazard Model|||||1.08|0.48|0.113
73924992|NCT01358357|147378704|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.09||||0.406|TWO_SIDED|95.0|-0.29|0.12||analysis of ANCOVA model contains treatment ,pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.12|-0.29|0.406
73924993|NCT01358357|147378705|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.11||||0.162|TWO_SIDED|95.0|-0.26|0.04||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.04|-0.26|0.162
73924994|NCT01358357|147378706|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.07||||0.496|TWO_SIDED|95.0|-0.27|0.13||Analysis of covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.13|-0.27|0.496
73968439|NCT03131648|147475187|SUPERIORITY||Difference of least square means|-6.4|||<|0.001|TWO_SIDED|95.0|-8.8|-4.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change will be imputed as 0.||-4.1|-8.8|<0.001
74028764|NCT02760407|147611513|SUPERIORITY||Risk Difference (RD)|0.27|||<|0.0001|TWO_SIDED|97.5|0.183|0.352|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rate for the 64 mg q4w treatment group at Week 12 was expected to be at least 50% resulting in an expected difference in ACR20 response rates of 25 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.352|0.183|<0.0001
73862282|NCT01443130|147270469|SUPERIORITY_OR_OTHER|||||||0.4501||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4501
73968440|NCT03131648|147475188|SUPERIORITY||Risk Difference (RD)|5.7||||0.007|TWO_SIDED|95.0|2.5|8.9||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered nonresponders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||8.9|2.5|0.007
73924995|NCT01358357|147378707|SUPERIORITY_OR_OTHER||LS mean difference|-0.8||||0.128|TWO_SIDED|95.0|-1.8|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pool country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.2|-1.8|0.128
73924996|NCT01358357|147378708|SUPERIORITY_OR_OTHER||LS mean difference lurasdione vs.Placebo|-0.5||||0.485|TWO_SIDED|95.0|-1.9|0.9||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.9|-1.9|0.485
73924997|NCT01358357|147378709|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.582|TWO_SIDED|95.0|-0.8|0.5||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.5|-0.8|0.582
73968441|NCT03131648|147475189|SUPERIORITY||Risk Difference (RD)|14.1|||<|0.001|TWO_SIDED|95.0|8.6|19.6||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference stratified by region and disease severity.|||19.6|8.6|<0.001
73968442|NCT03131648|147475190|SUPERIORITY||Difference of least square means|-0.9|||<|0.001|TWO_SIDED|95.0|-1.4|-0.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 1 change will be imputed as 0.||-0.4|-1.4|<0.001
74028765|NCT02760407|147611513|SUPERIORITY||Risk Difference (RD)|0.258|||<|0.0001|TWO_SIDED|97.5|0.171|0.341|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rate for the 64 mg q2w treatment group at Week 12 was expected to be at least 55%, resulting in an expected difference in ACR20 response rate of 30 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.341|0.171|<0.0001
73924998|NCT01358357|147378710|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.01||||0.42|TWO_SIDED|95.0|-0.5|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.2|-0.5|0.420
74028766|NCT02760407|147611514|SUPERIORITY||Risk Difference (RD)|0.224|||<|0.0001|TWO_SIDED|95.0|0.148|0.298|||Chi-squared|2x2 chi-square test||The ACR20 response rate for adalimumab was expected to be at least 52.5% at Week 12.||0.298|0.148|<0.0001
74087164|NCT02310763|147728279|SUPERIORITY||Mean Difference (Net)|2.9||||0.0926|TWO_SIDED|95.0|-0.5|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||6.3|-0.5|0.0926
74087165|NCT02310763|147728280|SUPERIORITY||Mean Difference (Net)|2.0||||0.3597|TWO_SIDED|95.0|-2.4|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||6.3|-2.4|0.3597
74087166|NCT02310763|147728280|SUPERIORITY||Mean Difference (Net)|0.5||||0.7345|TWO_SIDED|95.0|-2.3|3.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.3|-2.3|0.7345
73924999|NCT01358357|147378711|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.2||||0.788|TWO_SIDED|95.0|-1.6|1.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||1.2|-1.6|0.788
74087167|NCT02310763|147728280|SUPERIORITY||Mean Difference (Net)|4.0||||0.032|TWO_SIDED|95.0|0.4|7.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||7.7|0.4|0.0320
73862283|NCT01443130|147270469|SUPERIORITY_OR_OTHER|||||||0.1758||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1758
73925000|NCT01358357|147378712|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.1||||0.38|TWO_SIDED|95.0|-0.3|0.1||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.1|-0.3|0.380
73925001|NCT01358357|147378713|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|0.37||||0.772|TWO_SIDED|95.0|-2.14|2.88||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||2.88|-2.14|0.772
73925002|NCT01826487|147378714|OTHER||Mean Difference (Final Values)|12.98|STANDARD_ERROR_OF_MEAN|10.415||0.213|TWO_SIDED|95.0|-7.44|33.39||Threshold for significance at 0.05. Secondary endpoints were tested for significance, only if the primary endpoint was statistically significant.|Mixed Models Analysis|||Analysis was performed using analysis of covariance (ANCOVA) method including stratification factors for age (less than \[\<\] 9 years versus \[vs.\] greater than or equal to \[\>=\] 9 years), duration of use of corticosteroids at baseline (approx. \>=6 to \<12 months vs. \>=12 months), and baseline 6MWD category (\>=350 meters vs \<350 meters), as well as baseline 6MWD as covariate.||33.39|-7.44|0.213
73925003|NCT02136576|147378725|SUPERIORITY|||||||0.72||||||"This p-value is for the Air Schiff comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||0.72
73925004|NCT02136576|147378725|SUPERIORITY|||||||0.93||||||"This p-value is for the Air VAS comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.93
73968443|NCT03131648|147475191|SUPERIORITY||Risk Difference (RD)|15.2|||<|0.001|TWO_SIDED|95.0|9.2|21.3||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||21.3|9.2|<0.001
73968444|NCT03131648|147475192|SUPERIORITY||Risk Difference (RD)|13.0||||0.001|TWO_SIDED|95.0|5.4|20.5||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||20.5|5.4|0.001
73968445|NCT05324124|147475193|OTHER||Ratio of Geometric Least Squares Mean|0.952|||||TWO_SIDED|90.0|0.876|1.03||||||||1.03|0.876|
73968446|NCT05324124|147475194|OTHER||Ratio of Geometric Least Squares Mean|0.949|||||TWO_SIDED|90.0|0.869|1.04||||||||1.04|0.869|
73968447|NCT05324124|147475195|OTHER||Ratio of Geometric Least Squares Mean|0.829|||||TWO_SIDED|90.0|0.744|0.925||||||||0.925|0.744|
73968448|NCT04760678|147475231|OTHER|Fisher's exact test||||||0.107|||||||Fisher Exact|||||||0.107
74087168|NCT02310763|147728281|SUPERIORITY||Mean Difference (Net)|1.2||||0.3345|TWO_SIDED|95.0|-1.3|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||3.8|-1.3|0.3345
74087169|NCT02310763|147728281|SUPERIORITY||Mean Difference (Net)|-1.2||||0.14|TWO_SIDED|95.0|-2.9|0.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.4|-2.9|0.1400
74087170|NCT02310763|147728281|SUPERIORITY||Mean Difference (Net)|-0.9||||0.6764|TWO_SIDED|95.0|-5.4|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.6|-5.4|0.6764
74087171|NCT02310763|147728282|SUPERIORITY||Mean Difference (Net)|6.5||||0.097|TWO_SIDED|95.0|-1.2|14.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||14.2|-1.2|0.0970
74087172|NCT02310763|147728282|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6919|TWO_SIDED|95.0|-1.9|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||1.3|-1.9|0.6919
73925005|NCT02136576|147378725|SUPERIORITY|||||||0.77||||||"This p-value is for the WaterSchiff comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.77
73925006|NCT02136576|147378725|SUPERIORITY|||||||0.93||||||"This p-value is for the WaterVAS comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.93
73925007|NCT00537381|147378726|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.728||||0.014|TWO_SIDED|95.0|1.112|2.686|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.|||2.686|1.112|0.014
73925008|NCT00537381|147378727|SUPERIORITY_OR_OTHER|||||||0.795|||||||Fisher Exact|||||||0.795
73925009|NCT00537381|147378728|SUPERIORITY_OR_OTHER|||||||0.018|||||||Fisher Exact|||||||0.018
73925010|NCT00537381|147378729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.476||||0.163|TWO_SIDED|95.0|0.853|2.522|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.|||2.522|0.853|0.163
73925011|NCT02590939|147378733|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73925012|NCT02590939|147378734|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73968449|NCT01748448|147475251|SUPERIORITY||Cox Proportional Hazard|1.27|||=|0.324|TWO_SIDED|95.0|0.79|2.03|||Fisher Exact|||||2.03|0.79|= 0.324
73968450|NCT02907099|147475258|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.5
73968451|NCT02907099|147475259|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.5
73968452|NCT03675282|147475279|SUPERIORITY||Mean Difference (Final Values)|19.8||||0.66|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 (Baseline vs. 24 months)||||0.66
73968453|NCT03675282|147475279|SUPERIORITY||Mean Difference (Final Values)|-21.3||||0.63|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 (Baseline vs. 24 months)||||0.63
73968454|NCT03675282|147475279|SUPERIORITY||Mean Difference (Final Values)|0.87||||0.99|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder (Baseline vs. 24 months)||||0.99
73968455|NCT03675282|147475279|SUPERIORITY||Mean Difference (Final Values)|11.5||||0.67|TWO_SIDED||||||paired t-test|||Healthy Controls (Baseline vs. 24 months)||||0.67
73968456|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-0.625||||0.4|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part I (Baseline vs. 24 months)||||0.40
73968457|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-1.453||||0.4|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part II (Baseline vs. 24 months)||||0.40
73925013|NCT02590939|147378735|SUPERIORITY|||||||0.666||||||Statistical significance threshold set to 0.05|Fisher Exact|||||||0.666
73925014|NCT02590939|147378736|SUPERIORITY|||||||0.026||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.026
73925015|NCT02590939|147378737|SUPERIORITY|||||||1||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||1
73925016|NCT02590939|147378738|SUPERIORITY|||||||0.037||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.037
73925017|NCT02590939|147378739|SUPERIORITY|||||||0.028||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.028
73925018|NCT02590939|147378740|SUPERIORITY|||||||0.062||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.062
73925019|NCT01698463|147378776|OTHER||||||<|0.05||||||\<0.05 (threshold for significance).|Wilcoxon (Mann-Whitney)|||||||<0.05
73925020|NCT04709575|147378777|SUPERIORITY||linear mixed-effect model|-0.995||||0.0497|TWO_SIDED|95.0|-1.9886|-0.0011|||LS Mean Difference|||||-0.0011|-1.9886|0.0497
73925021|NCT05477875|147378852|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.538|||||||Wilcoxon (Mann-Whitney)|||||||0.538
73925022|NCT05477875|147378853|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.538|||||||ANOVA|||||||0.538
73925023|NCT05477875|147378854|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.516|||||||ANOVA|||||||0.516
73925024|NCT05477875|147378855|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and PROWL-SS from (1-100) as the dependent variable."|||||<|0.851|||||||ANOVA|||||||<0.851
73925025|NCT05477875|147378856|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and QIRC from (1-100) as the dependent variable."|||||<|0.543|||||||ANOVA|||||||<0.543
73925026|NCT05477875|147378857|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and OSDI from (0-48) as the dependent variable."||||||0.725|||||||ANOVA|||||||0.725
73925027|NCT05477875|147378858|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.516|||||||ANOVA|||||||0.516
73925028|NCT04865354|147378892|NON_INFERIORITY|Noninferiority to be concluded if least squares means difference upper confidence limit is less than 0.05.|Least Squares Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0034|||ONE_SIDED|95.0||0.009||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.||LSM results based on general linear mixed effects model with terms for lens, period and sequence as fixed effects, subject as a random effect|Difference = PRECISION1 minus Clariti 1-Day|||0.009||
73968458|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-6.15||||0.04|TWO_SIDED|||||Parkinson Disease - Stage 1 UPDRS Part III (Baseline vs. 24 months)|paired t-test|||||||0.04
73968459|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-0.056||||0.94|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part IV (Baseline vs. 24 months)||||0.94
73968460|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-0.414||||0.53|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part I (Baseline vs. 24 months)||||0.53
73968461|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-1.779||||0.38|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part II (Baseline vs. 24 months)||||0.38
73968462|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-3.59||||0.24|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part III (Baseline vs. 24 months)||||0.24
73968463|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-0.376||||0.73|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part IV (Baseline vs. 24 months)||||0.73
73968464|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-1.187||||0.16|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part I (Baseline vs. 24 months)||||0.16
73968465|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-0.154||||0.75|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part II (Baseline vs. 24 months)||||0.75
73968466|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-0.829||||0.28|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part III (Baseline vs. 24 months)||||0.28
73968467|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-0.077||||0.85|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part IV (Baseline vs. 24 months)||||0.85
73968468|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|0.204||||0.78|TWO_SIDED||||||paired t-test|||Healthy Controls UPDRS Part I (Baseline vs. 24 months)||||0.78
73968469|NCT03675282|147475280|SUPERIORITY||Mean Difference (Final Values)|-0.381||||0.03|TWO_SIDED||||||paired t-test|||Healthy Controls UPDRS Part IV (Baseline vs. 24 months)||||0.03
74028767|NCT02760407|147611514|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined non-inferiority margin of -12%.|Risk Difference (RD)|0.045|||||TWO_SIDED|97.5|-0.022|0.112||||||A noninferiority margin of 12% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.112|-0.022|
74028768|NCT02760407|147611514|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined non-inferiority margin of -12%.|Risk Difference (RD)|0.034|||||TWO_SIDED|97.5|-0.035|0.102||||||A noninferiority margin of 12% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.102|-0.035|
74087173|NCT02310763|147728282|SUPERIORITY||Mean Difference (Net)|-1.0||||0.6736|TWO_SIDED|95.0|-5.8|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.9|-5.8|0.6736
73968470|NCT03675282|147475281|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.3|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 (Baseline vs. 24 months)||||0.30
73968471|NCT03675282|147475281|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.94|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 (Baseline vs. 24 months)||||0.94
73968472|NCT03675282|147475281|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.45|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder (Baseline vs. 24 months)||||0.45
73968473|NCT03675282|147475281|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8|TWO_SIDED||||||paired t-test|||Healthy Controls (Baseline vs. 24 months)||||0.80
73968474|NCT05875142|147475282|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0008|||||||t-test, 1 sided|||T compared with TM||||0.0008
73968475|NCT05875142|147475282|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||5.03e-06|||||||t-test, 1 sided|||T compared with TMC.||||0.00000503
73968476|NCT05875142|147475283|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0176|||||||t-test, 1 sided|||T compared with T||||0.0176
73968477|NCT05875142|147475283|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0056|||||||t-test, 1 sided|||Comparing T with TMC.||||0.0056
73968478|NCT05875142|147475284|NON_INFERIORITY|test of non-inferiority is H0: control\<=treatment vs HA: control\>treatment||||||0.4066|||||||t-test, 1 sided|||T compared with TM||||0.4066
73968479|NCT05875142|147475284|NON_INFERIORITY|test of non-inferiority is H0: control\<=treatment vs HA: control\>treatment||||||0.4045|||||||t-test, 1 sided|||T compared with TMC||||0.4045
73968480|NCT03232138|147475292|EQUIVALENCE|2-sided P-value in the analysis|Mean Difference (Final Values)|0.22||||0.452|TWO_SIDED|95.0|0.03|0.41||Hypothesis: sulforaphane treatment slows or reverse the progression of lung histological lesions or lower the dysplasia score.|ANCOVA|ANCOVA model includes baseline average endobronchial histopathological scores,age,sex,cigarettes per day,years of smoking, years since quit smoking.||Derived from ANCOVA model with adjustment for baseline average endobronchial histopathological scores, age, sex, cigarettes per day, years of smoking, and years since quit smoking.||0.41|0.03|0.452
73968481|NCT03232138|147475292|EQUIVALENCE|2-sided P-value in the analysis|Mean Difference (Final Values)|0.12||||0.452|TWO_SIDED|95.0|-0.04|0.28||Hypothesis: sulforaphane treatment slows or reverse the progression of lung histological lesions or lower the dysplasia score.|ANCOVA|ANCOVA model includes baseline average endobronchial histopathological scores,age,sex,cigarettes per day,years of smoking, years since quit smoking||Derived from ANCOVA model with adjustment for baseline average endobronchial histopathological scores, age, sex, cigarettes per day, years of smoking, and years since quit smoking.||0.28|-0.04|0.452
73968482|NCT03232138|147475293|EQUIVALENCE|2-sided P-value in the analysis||||||0.738||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||All positive nuclei. Mean (95%CI) changes in baseline.||||0.738
74028769|NCT02760407|147611515|SUPERIORITY||Risk Difference (RD)|0.332|||<|0.0001|TWO_SIDED|97.5|0.257|0.397|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 is estimated to be 10% in the placebo group and 22% in the 64 mg q4w OKZ group, resulting in an expected difference of 12 percentage points between respective OKZ group and placebo.||0.397|0.257|<0.0001
74087174|NCT02310763|147728283|SUPERIORITY||Mean Difference (Net)|0.0||||0.9582|TWO_SIDED|95.0|-1.5|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||1.5|-1.5|0.9582
73925029|NCT01925404|147378893|SUPERIORITY|We fitted difference-in-differences (DID) models between the two measurement waves and four study arms. The effect of the intervention was modeled as the wave by study arm interaction. All models used random effects to account for intra-class correlation within each park as well as fixed effects to account for observation times (time of day, weekend versus weekdays).||||||0.0063||||||Significance threshold. p=0.05|negative binomial distribution|||Comparison of change from baseline;||||.0063
73968483|NCT03232138|147475293|EQUIVALENCE|2-sided P-value in the analysis||||||0.78||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Weak-intensity positive nuclei. Mean (95%CI) baseline.||||0.780
73968484|NCT03232138|147475293|EQUIVALENCE|2-sided P-value in the analysis||||||0.733||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Moderate intensity positive nuclei. Mean (95%CI) changes in baseline.||||0.733
73968485|NCT03232138|147475293|EQUIVALENCE|2-sided P-value in the analysis||||||0.751||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Strong-Intensity positive nuclei. Mean (95%CI) changes in baseline.||||0.751
73968486|NCT03232138|147475293|EQUIVALENCE|2-sided P-value in the analysis||||||0.014||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of Ki-67 positive nuclei||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.014
73968487|NCT03232138|147475293|EQUIVALENCE|2-sided P-value in the analysis||||||0.056|||||||Covariance|Analysis of Covariance adjustment age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Week intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.056
73968488|NCT03232138|147475293|EQUIVALENCE|2-sided P-value in the analysis||||||0.028|||||||Analysis of Covariance|Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Moderate Intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.028
73925030|NCT04254978|147378914|SUPERIORITY||||||<|0.0001|||||||Exact binomial distribution|||Comparison of the true response rate of bomedemstat to a fixed efficacy target of 5%: Null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p \> 0.05||||<.0001
73968489|NCT03232138|147475293|EQUIVALENCE|2-sided P-value in the analysis||||||0.004|||||||Analysis of Covariance|Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.004
73968490|NCT03232138|147475294|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline for positive cells. TUNEL positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.377||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies compared with the place|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||All positive nuclei. Mean (95%CI) baseline.||||0.377
74087175|NCT02310763|147728283|SUPERIORITY||Mean Difference (Net)|-0.1||||0.8629|TWO_SIDED|95.0|-1.8|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||1.5|-1.8|0.8629
73968491|NCT03232138|147475294|EQUIVALENCE|2-sided P-value in the analysis||||||0.413||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Weak-intensity positive nuclei. Mean (95%CI) baseline.||||0.413
73968492|NCT03232138|147475294|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline Moderate-intensity positive nuclei. TUNEL positive (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.338||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies compared with the place|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Moderate Intensity positive nuclei. Mean (95%CI) at baseline.||||0.338
73968493|NCT03232138|147475294|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline for positive cells. TUNEL positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.547||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Strong-intensity positive nuclei. Mean (95%CI) baseline.||||0.547
73968494|NCT03232138|147475294|EQUIVALENCE|used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.291||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.291
74087176|NCT02310763|147728283|SUPERIORITY||Mean Difference (Net)|-0.9||||0.6746|TWO_SIDED|95.0|-5.5|3.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.7|-5.5|0.6746
73925031|NCT02094716|147378915|SUPERIORITY|||||||0.6084|||||||Chi-squared|||||||0.6084
73925032|NCT02094716|147378917|SUPERIORITY|||||||0.6937|||||||Chi-squared|||||||0.6937
73925033|NCT02094716|147378918|SUPERIORITY|||||||0.101|||||||Fisher Exact|||||||0.1010
73925034|NCT02094716|147378918|SUPERIORITY|||||||0.0764|||||||Fisher Exact|||||||0.0764
73925035|NCT02515942|147378921|SUPERIORITY|Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.|Treatment Effect|-0.35||||0.0636|TWO_SIDED|80.0|-0.64|-0.06|||ANCOVA|||||-0.06|-0.64|0.0636
73925036|NCT02515942|147378921|SUPERIORITY||Treatment Effect|-0.29||||0.1019|TWO_SIDED|80.0|-0.59|0.0|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.||0.00|-0.59|0.1019
73925037|NCT02515942|147378921|SUPERIORITY||Treatment Effect|0.06||||0.5987|TWO_SIDED|80.0|-0.24|0.35|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.||0.35|-0.24|0.5987
73925038|NCT02515942|147378922|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.5029|TWO_SIDED|80.0|-0.11|0.11|||Mixed Models Analysis|||Change from baseline at Day 85||0.11|-0.11|0.5029
73925039|NCT02515942|147378922|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.682|TWO_SIDED|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85||0.14|-0.07|0.6820
73968495|NCT03232138|147475294|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.552||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Weak-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.552
73968496|NCT03232138|147475294|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.205||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Moderate-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.205
73968497|NCT03232138|147475294|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.295||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Strong-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.295
73968498|NCT03232138|147475295|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.295||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||All positive nuclei. Mean (95%CI) at baseline.||||0.295
74028770|NCT02760407|147611515|SUPERIORITY||Risk Difference (RD)|0.325|||<|0.0001|TWO_SIDED|97.5|0.25|0.391|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 is estimated to be 10% in the placebo group and 30% in the 64 mg q2w OKZ group, resulting in an expected difference of 20 percentage points between respective OKZ group and placebo.||0.391|0.250|<0.0001
74028771|NCT02760407|147611516|SUPERIORITY||Risk Difference (RD)|0.256|||<|0.0001|TWO_SIDED|95.0|0.191|0.313|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity response rate for adalimumab was expected to be at least 27% at Week 12.||0.313|0.191|<0.0001
74087177|NCT02310763|147728284|SUPERIORITY||Mean Difference (Net)|-5.8||||0.7483|TWO_SIDED|95.0|-42.4|30.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||30.7|-42.4|0.7483
74087178|NCT02310763|147728284|SUPERIORITY||Mean Difference (Net)|-1.3||||0.9053|TWO_SIDED|95.0|-23.9|21.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||21.2|-23.9|0.9053
73925040|NCT02515942|147378922|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.6826|TWO_SIDED|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85||0.14|-0.07|0.6826
73925041|NCT02515942|147378922|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.12||||0.1545|TWO_SIDED|80.0|-0.28|0.03|||Mixed Models Analysis|||Change from baseline at Day 169||0.03|-0.28|0.1545
74087179|NCT02310763|147728284|SUPERIORITY||Mean Difference (Net)|13.1||||0.6896|TWO_SIDED|95.0|-53.4|79.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||79.7|-53.4|0.6896
73925042|NCT02515942|147378922|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.13||||0.1398|TWO_SIDED|80.0|-0.29|0.02|||Mixed Models Analysis|||Change from baseline at Day 169||0.02|-0.29|0.1398
73925043|NCT02515942|147378922|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.01||||0.4717|TWO_SIDED|80.0|-0.16|0.14|||Mixed Models Analysis|||Change from baseline at Day 169||0.14|-0.16|0.4717
73925044|NCT02515942|147378922|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.25||||0.053|TWO_SIDED|80.0|-0.45|-0.05|||Mixed Models Analysis|||Change from baseline at Day 253||-0.05|-0.45|0.0530
73925045|NCT02515942|147378922|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.17||||0.1386|TWO_SIDED|80.0|-0.37|0.03|||Mixed Models Analysis|||Change from baseline at Day 253||0.03|-0.37|0.1386
73925046|NCT02515942|147378922|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.08||||0.7087|TWO_SIDED|80.0|-0.11|0.27|||Mixed Models Analysis|||Change from baseline at Day 253||0.27|-0.11|0.7087
73925047|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.72||||0.9243|TWO_SIDED|80.0|-5.15|-0.29|||Mixed Models Analysis|||Change from baseline at Day 2||-0.29|-5.15|0.9243
73968499|NCT03232138|147475295|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.242||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||weak intensity positive nuclei. Mean (95%CI) at baseline.||||0.242
73968500|NCT03232138|147475295|EQUIVALENCE|-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.985||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Moderate intensity positive nuclei. Mean (95%CI) at baseline.||||0.985
73968501|NCT03232138|147475295|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.547||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Strong intensity positive nuclei. Mean (95%CI) at baseline.||||0.547
73968502|NCT03232138|147475295|EQUIVALENCE|used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.778||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.778
74087180|NCT02310763|147728285|SUPERIORITY||Mean Difference (Net)|-3.7||||0.8117|TWO_SIDED|95.0|-34.8|27.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||27.5|-34.8|0.8117
74087181|NCT02310763|147728285|SUPERIORITY||Mean Difference (Net)|7.3||||0.6018|TWO_SIDED|95.0|-20.6|35.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||35.2|-20.6|0.6018
73925048|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.51||||0.3929|TWO_SIDED|80.0|-1.89|2.91|||Mixed Models Analysis|||Change from baseline at Day 2||2.91|-1.89|0.3929
73925049|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.23||||0.0418|TWO_SIDED|80.0|0.85|5.61|||Mixed Models Analysis|||Change from baseline at Day 2||5.61|0.85|0.0418
73925050|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.32||||0.5632|TWO_SIDED|80.0|-2.91|2.27|||Mixed Models Analysis|||Change from baseline at Day 8||2.27|-2.91|0.5632
73968503|NCT03232138|147475295|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker||||||0.685||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Weak intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.685
73968504|NCT03232138|147475295|EQUIVALENCE|-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker||||||0.469||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Moderate intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.469
73968505|NCT03232138|147475295|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarke||||||0.052||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.052
73968506|NCT03232138|147475296|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung cancer. the objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RNA integrity number or RIN.|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.1||0.82|TWO_SIDED|||||Hypothesis: Sulforaphane treatment downregulate these genes whose over-expressions are associated with risk of lung cancer.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after 12-month sulforaphane treatment.|||||0.82
73968507|NCT03232138|147475297|EQUIVALENCE|This analysis was focused on the gene set that were found to be down-regulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated down-regulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.5|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate these genes whose down-expressions are associated with lung cancer risk.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after 12-month sulforaphane treatment.|||||0.50
73968508|NCT03232138|147475298|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung pre-malignant lesions. The objective was to examine if sulforaphane treatment for 12 months would have any significant impact on the expression of these pre-malignant lesions associated upregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.15|STANDARD_ERROR_OF_MEAN|0.15||0.32|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would downregulate these genes whose over-expressions are associated with risk of lung pre-malignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.32
73968509|NCT03232138|147475299|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung pre-malignant lesions. The objective was to examine if sulforaphane treatment for 12 months would have any significant impact on the expression of these pre-malignant lesions associated downregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate these genes whose down-regulated expressions are associated with risk of lung pre-malignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.5
74028772|NCT02760407|147611516|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined noninferiority margin of -7.5%.|Risk Difference (RD)|0.076|||||TWO_SIDED|97.5|0.004|0.147||||||A noninferiority margin of 7.5% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.147|0.004|
74087182|NCT02310763|147728285|SUPERIORITY||Mean Difference (Net)|16.3||||0.7152|TWO_SIDED|95.0|-73.4|106.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||106.0|-73.4|0.7152
73925051|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2575|TWO_SIDED|80.0|-1.25|3.83|||Mixed Models Analysis|||Change from baseline at Day 8||3.83|-1.25|0.2575
73925052|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.61||||0.2058|TWO_SIDED|80.0|-0.91|4.12|||Mixed Models Analysis|||Change from baseline at Day 8||4.12|-0.91|0.2058
73925053|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8392|TWO_SIDED|80.0|-4.44|0.57|||Mixed Models Analysis|||Change from baseline at Day 15||0.57|-4.44|0.8392
73925054|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effecgt|-0.12||||0.5255|TWO_SIDED|80.0|-2.59|2.35|||Mixed Models Analysis|||Change from baseline at Day 15||2.35|-2.59|0.5255
73925055|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.81||||0.1685|TWO_SIDED|80.0|-0.61|4.24|||Mixed Models Analysis|||Change from baseline at Day 15||4.24|-0.61|0.1685
73925056|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment|-2.01||||0.8544|TWO_SIDED|80.0|-4.45|0.43|||Mixed Models Analysis|||Change from baseline at Day 29||0.43|-4.45|0.8544
73925057|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.03||||0.1402|TWO_SIDED|80.0|-0.38|4.44|||Mixed Models Analysis|||Change from baseline at Day 29||4.44|-0.38|0.1402
73925058|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.03||||0.015|TWO_SIDED|80.0|1.67|6.4|||Mixed Models Analysis|||Change from baseline at Day 29||6.40|1.67|0.0150
73925059|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.14||||0.4682|TWO_SIDED|80.0|-2.11|2.39|||Mixed Models Analysis|||Change from baseline at Day 30||2.39|-2.11|0.4682
73925060|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.38||||0.4125|TWO_SIDED|80.0|-1.84|2.6|||Mixed Models Analysis|||Change from baseline at Day 30||2.60|-1.84|0.4125
73925061|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.24||||0.4431|TWO_SIDED|80.0|-1.94|2.42|||Mixed Models Analysis|||Change from baseline at Day 30||2.42|-1.94|0.4431
73925062|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.04||||0.6924|TWO_SIDED|80.0|-3.72|1.63|||Mixed Models Analysis|||Change from baseline at Day 57||1.63|-3.72|0.6924
73925063|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.61||||0.616|TWO_SIDED|80.0|-3.26|2.04|||Mixed Models Analysis|||Change from baseline at Day 57||2.04|-3.26|0.6160
73925064|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.44||||0.4149|TWO_SIDED|80.0|-2.18|3.06|||Mixed Models Analysis|||Change from baseline at Day 57||3.06|-2.18|0.4149
73925065|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2582|TWO_SIDED|80.0|-1.27|3.85|||Mixed Models Analysis|||Change from baseline at Day 85||3.85|-1.27|0.2582
74087183|NCT02310763|147728286|SUPERIORITY||Mean Difference (Net)|7.0||||0.719|TWO_SIDED|95.0|-32.1|46.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||46.1|-32.1|0.7190
73925066|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.81||||0.3402|TWO_SIDED|80.0|-1.72|3.34|||Mixed Models Analysis|||Change from baseline at Day 85||3.34|-1.72|0.3402
73925067|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.48||||0.5976|TWO_SIDED|80.0|-2.99|2.03|||Mixed Models Analysis|||Change from baseline at Day 85||2.03|-2.99|0.5976
73925068|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.5||||0.5916|TWO_SIDED|80.0|-3.3|2.29|||Mixed Models Analysis|||Change from baseline at Day 113||2.29|-3.30|0.5916
73968510|NCT03232138|147475300|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|||||Sulforaphane treatment would downregulate the expression of these genes whose upregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung cancer.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.012
73968511|NCT03232138|147475301|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.38|STANDARD_ERROR_OF_MEAN|0.12||0.0045|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate the expression of these genes whose downregulated expressions in nasal epithelial cells have been found to be associated with risk of lung cancer.|Mixed Models Analysis||Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.0045
73968512|NCT03232138|147475302|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.17|STANDARD_ERROR_OF_MEAN|0.16||0.32|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would downregulate the expression of these genes whose upregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung premalignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.32
73968513|NCT03232138|147475303|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated downregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.27|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate the expression of these genes whose downregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung premalignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.27
73968514|NCT03232138|147475304|EQUIVALENCE|Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer||||||0.59||||||For severity by treatment group.|Fisher Exact|||||||0.590
74087184|NCT02310763|147728286|SUPERIORITY||Mean Difference (Net)|-15.8||||0.4634|TWO_SIDED|95.0|-58.9|27.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||27.3|-58.9|0.4634
74087185|NCT02310763|147728286|SUPERIORITY||Mean Difference (Net)|3.9||||0.94|TWO_SIDED|95.0|-100.7|108.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||108.5|-100.7|0.9400
73925069|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5564|TWO_SIDED|80.0|-3.05|2.45|||Mixed Models Analysis|||Change from baseline at Day 113||2.45|-3.05|0.5564
73925070|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.2||||0.4625|TWO_SIDED|80.0|-2.53|2.93|||Mixed Models Analysis|||Change from baseline at Day 113||2.93|-2.53|0.4625
74087186|NCT02310763|147728290|SUPERIORITY||Mean Difference (Net)|2.945||||0.0087|TWO_SIDED|95.0|0.7597|5.1309||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||5.1309|0.7597|0.0087
73925071|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8221|TWO_SIDED|80.0|-4.64|0.76|||Mixed Models Analysis|||Change from baseline at Day 141||0.76|-4.64|0.8221
73925072|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.98||||0.3179|TWO_SIDED|80.0|-1.68|3.64|||Mixed Models Analysis|||Change from baseline at Day 141||3.64|-1.68|0.3179
73925073|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.92||||0.0773|TWO_SIDED|80.0|0.29|5.55|||Mixed Models Analysis|||Change from baseline at Day 141||5.55|0.29|0.0773
73925074|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6708|TWO_SIDED|80.0|-3.71|1.81|||Mixed Models Analysis|||Change from baseline at Day 169||1.81|-3.71|0.6708
73925075|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.99||||0.679|TWO_SIDED|80.0|-3.71|1.74|||Mixed Models Analysis|||Change from baseline at Day 169||1.74|-3.71|0.6790
73925076|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.04||||0.507|TWO_SIDED|80.0|-2.72|2.64|||Mixed Models Analysis|||Change from baseline at Day 169||2.64|-2.72|0.5070
73925077|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5487|TWO_SIDED|80.0|-3.44|2.84|||Mixed Models Analysis|||Change from baseline at Day 197||2.84|-3.44|0.5487
73925078|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.25||||0.6973|TWO_SIDED|80.0|-4.35|1.85|||Mixed Models Analysis|||Change from baseline at Day 197||1.85|-4.35|0.6973
73925079|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6548|TWO_SIDED|80.0|-4.0|2.11|||Mixed Models Analysis|||Change from baseline at Day 197||2.11|-4.00|0.6548
74087187|NCT02310763|147728290|SUPERIORITY||Mean Difference (Net)|2.918||||0.0536|TWO_SIDED|95.0|-0.0461|5.8811||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||5.8811|-0.0461|0.0536
73925080|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.35||||0.5533|TWO_SIDED|80.0|-3.76|3.05|||Mixed Models Analysis|||Change from baseline at Day 225||3.05|-3.76|0.5533
73925081|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3358|TWO_SIDED|80.0|-2.25|4.46|||Mixed Models Analysis|||Change from baseline at Day 225||4.46|-2.25|0.3358
73925082|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.46||||0.285|TWO_SIDED|80.0|-1.85|4.77|||Mixed Models Analysis|||Change from baseline at Day 225||4.77|-1.85|0.2850
73925083|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.55||||0.5778|TWO_SIDED|80.0|-4.14|3.04|||Mixed Models Analysis|||Change from baseline at Day 253||3.04|-4.14|0.5778
73925084|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.3||||0.2018|TWO_SIDED|80.0|-1.24|5.85|||Mixed Models Analysis|||Change from baseline at Day 253||5.85|-1.24|0.2018
73925085|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.85||||0.1457|TWO_SIDED|80.0|-0.62|6.32|||Mixed Models Analysis|||Change from baseline at Day 253||6.32|-0.62|0.1457
73925086|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.56||||0.5758|TWO_SIDED|80.0|-4.29|3.18|||Mixed Models Analysis|||Change from baseline at Day 281||3.18|-4.29|0.5758
73925087|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.85||||0.3833|TWO_SIDED|80.0|-2.84|4.55|||Mixed Models Analysis|||Change from baseline at Day 281||4.55|-2.84|0.3833
73925088|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.41||||0.3083|TWO_SIDED|80.0|-2.21|5.02|||Mixed Models Analysis|||Change from baseline at Day 281||5.02|-2.21|0.3083
73968515|NCT03232138|147475304|EQUIVALENCE|Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer||||||0.131||||||For attribution by treatment group.|Fisher Exact|||||||0.131
73968516|NCT05260684|147475330|OTHER||Hazard Ratio (HR)|1.32||||0.02|TWO_SIDED|95.0|1.05|1.65|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Dabrafenib+Trametinib relative to Encorafenib+Binimetinib (reference).||1.65|1.05|0.02
73968517|NCT05260684|147475330|OTHER||Hazard Ratio (HR)|1.17||||0.47|TWO_SIDED|95.0|0.76|1.79|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Vemurafenib + Cobimetinib relative to Encorafenib+Binimetinib (reference).||1.79|0.76|0.47
74087188|NCT02310763|147728290|SUPERIORITY||Mean Difference (Net)|4.087||||0.0298|TWO_SIDED|95.0|0.4069|7.7677||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||7.7677|0.4069|0.0298
74087189|NCT02310763|147728291|SUPERIORITY||Mean Difference (Net)|1.575||||0.0684|TWO_SIDED|95.0|-0.1213|3.2715||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||3.2715|-0.1213|0.0684
74087190|NCT02310763|147728291|SUPERIORITY||Mean Difference (Net)|2.612||||0.0376|TWO_SIDED|95.0|0.1521|5.0711||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||5.0711|0.1521|0.0376
73968518|NCT05260684|147475331|OTHER||Hazard Ratio (HR)|1.49|||<|0.001|TWO_SIDED|95.0|1.2|1.87|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Dabrafenib+Trametinib relative to Encorafenib+Binimetinib (reference).||1.87|1.20|<0.001
74087191|NCT02310763|147728291|SUPERIORITY||Mean Difference (Net)|3.208||||0.0411|TWO_SIDED|95.0|0.1318|6.2844||The significance level is 0.05|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||6.2844|0.1318|0.0411
74087192|NCT01040793|147728341|SUPERIORITY_OR_OTHER||Ratio to placebo|1.118|STANDARD_ERROR_OF_MEAN|0.04||0.0018||95.0|1.043|1.199|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo|||1.199|1.043|0.0018
73925089|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.54||||0.7063|TWO_SIDED|80.0|-5.19|2.11|||Mixed Models Analysis|||Change from baseline at Day 309||2.11|-5.19|0.7063
73968519|NCT05260684|147475331|OTHER||Hazard Ratio (HR)|1.2||||0.4|TWO_SIDED|95.0|0.79|1.82|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Vemurafenib + Cobimetinib relative to Encorafenib+Binimetinib (reference).||1.82|0.79|0.40
73968520|NCT03891667|147475351|SUPERIORITY||Odds Ratio (OR)|4.0|||||TWO_SIDED|95.0|0.21|75.66||||||||75.66|.21|
73968521|NCT03891667|147475352|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.05|9.47||||||||9.47|0.05|
73968522|NCT00534469|147475366|OTHER|Two-sided test.||||||0.43||||||Log-rank test (Mantel-Haenszel test). This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Log Rank|||Null hypothesis: All four groups are drawn from the same distribution. Alternative hypothesis: At least one of the groups has measurably different survival from the others.||||0.43
73968523|NCT05717907|147475369|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.000
73968524|NCT04359108|147475453|OTHER|||||||0.02|||||||ANOVA|||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||0.02
73968525|NCT04359108|147475453|OTHER|||||||0.22|||||||t-test, 2 sided|||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||0.22
73968526|NCT04359108|147475453|OTHER|||||||0.017|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.017
74087193|NCT01040793|147728341|SUPERIORITY_OR_OTHER||Ratio to placebo|1.105|STANDARD_ERROR_OF_MEAN|0.039||0.0052||95.0|1.03|1.184|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo|||1.184|1.030|0.0052
73925090|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.14||||0.2227|TWO_SIDED|80.0|-1.46|5.74|||Mixed Models Analysis|||Change from baseline at Day 309||5.74|-1.46|0.2227
73925091|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0907|TWO_SIDED|80.0|0.15|7.21|||Mixed Models Analysis|||Change from baseline at Day 309||7.21|0.15|0.0907
73925092|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.17||||0.4799|TWO_SIDED|80.0|-4.23|4.57|||Mixed Models Analysis|||Change from baseline at Day 337||4.57|-4.23|0.4799
73925093|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.2||||0.5237|TWO_SIDED|80.0|-4.54|4.14|||Mixed Models Analysis|||Change from baseline at Day 337||4.14|-4.54|0.5237
73925094|NCT02515942|147378924|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.37||||0.5451|TWO_SIDED|80.0|-4.62|3.87|||Mixed Models Analysis|||Change from baseline at Day 337||3.87|-4.62|0.5451
73925095|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.15||||0.4609|TWO_SIDED|80.0|-1.79|2.09|||Mixed Models Analysis|||Change from baseline at Day 2||2.09|-1.79|0.4609
73925096|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.3771|TWO_SIDED|80.0|-1.44|2.37|||Mixed Models Analysis|||Change from baseline at Day 2||2.37|-1.44|0.3771
73925097|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.32||||0.4161|TWO_SIDED|80.0|-1.6|2.24|||Mixed Models Analysis|||Change from baseline at Day 2||2.24|-1.60|0.4161
73925098|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.88||||0.9385|TWO_SIDED|80.0|-5.26|-0.49|||Mixed Models Analysis|||Change from baseline at Day 29||-0.49|-5.26|0.9385
74087194|NCT01040793|147728342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.035||0.0155||95.0|0.016|0.152|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.152|0.016|0.0155
74087195|NCT01040793|147728342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.098|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.234|0.098|<0.0001
73925099|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.4||||0.5862|TWO_SIDED|80.0|-2.76|1.96|||Mixed Models Analysis|||Change from baseline at Day 29||1.96|-2.76|0.5862
73925100|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.48||||0.0875|TWO_SIDED|80.0|0.14|4.82|||Mixed Models Analysis|||Change from baseline at Day 29||4.82|0.14|0.0875
73925101|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.53||||0.4059|TWO_SIDED|80.0|-2.32|3.37|||Mixed Models Analysis|||Change from baseline at Day 57||3.37|-2.32|0.4059
73925102|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.24||||0.286|TWO_SIDED|80.0|-1.58|4.05|||Mixed Models Analysis|||Change from baseline at Day 57||4.05|-1.58|0.2860
73925103|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.71||||0.3727|TWO_SIDED|80.0|-2.1|3.52|||Mixed Models Analysis|||Change from baseline at Day 57||3.52|-2.10|0.3727
73968527|NCT04359108|147475453|OTHER|||||||0.98|||||||t-test, 2 sided|||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.98
73968528|NCT04359108|147475453|OTHER|||||||0.014|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||0.014
74028773|NCT02760407|147611516|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined noninferiority margin of -7.5%.|Risk Difference (RD)|0.069|||||TWO_SIDED|97.5|-0.003|0.141||||||A noninferiority margin of 7.5% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.141|-0.003|
74028774|NCT02760407|147611517|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|97.5|-0.29|-0.09|||ANCOVA|||||-0.09|-0.29|<0.0001
73925104|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.91||||0.336|TWO_SIDED|80.0|-1.85|3.66|||Mixed Models Analysis|||Change from baseline at Day 85||3.66|-1.85|0.3360
73925105|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.95||||0.0316|TWO_SIDED|80.0|1.24|6.66|||Mixed Models Analysis|||Change from baseline at Day 85||6.66|1.24|0.0316
73925106|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.04||||0.0762|TWO_SIDED|80.0|0.32|5.76|||Mixed Models Analysis|||Change from baseline at Day 85||5.76|0.32|0.0762
73925107|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0544|TWO_SIDED|80.0|0.75|6.61|||Mixed Models Analysis|||Change from baseline at Day 113||6.61|0.75|0.0544
74028775|NCT02760407|147611517|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|97.5|-0.33|-0.12|||ANCOVA|||||-0.12|-0.33|<0.0001
73925108|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.91||||0.1955|TWO_SIDED|80.0|-0.95|4.77|||Mixed Models Analysis|||Change from baseline at Day 113||4.77|-0.95|0.1955
73925109|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.77||||0.7844|TWO_SIDED|80.0|-4.65|1.12|||Mixed Models Analysis|||Change from baseline at Day 113||1.12|-4.65|0.7844
73925110|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.49||||0.2973|TWO_SIDED|80.0|-2.11|5.08|||Mixed Models Analysis|||Change from baseline at Day 141||5.08|-2.11|0.2973
73968529|NCT04359108|147475453|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
73968530|NCT04359108|147475453|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
73968531|NCT04359108|147475453|OTHER|||||||0.156|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.156
73968532|NCT04359108|147475453|OTHER|||||||0.541|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.541
73968533|NCT04359108|147475453|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
74028776|NCT02760407|147611517|OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|95.0|-0.28|-0.1||||||||-0.10|-0.28|
74028777|NCT02760407|147611518|SUPERIORITY||Risk Difference (RD)|0.275|||<|0.0001|TWO_SIDED|97.5|0.192|0.349|||Chi-squared|2x2 chi-square test||||0.349|0.192|<0.0001
74028778|NCT02760407|147611518|SUPERIORITY||Risk Difference (RD)|0.278|||<|0.0001|TWO_SIDED|97.5|0.195|0.353|||Chi-squared|2x2 chi-square test||||0.353|0.195|<0.0001
74028779|NCT02760407|147611518|OTHER||Risk Difference (RD)|0.237|||||TWO_SIDED|95.0|0.165|0.303||||||||0.303|0.165|
74028780|NCT02760407|147611519|SUPERIORITY||Risk Difference (RD)|0.08||||0.0003|TWO_SIDED|97.5|0.031|0.123|||Chi-squared|2x2 chi-square test||||0.123|0.031|0.0003
74028781|NCT02760407|147611519|SUPERIORITY||Risk Difference (RD)|0.069||||0.001|TWO_SIDED|97.5|0.02|0.111|||Chi-squared|2x2 chi-square test||||0.111|0.020|0.001
74028782|NCT02760407|147611519|OTHER||Risk Difference (RD)|0.089|||||TWO_SIDED|95.0|0.046|0.127||||||||0.127|0.046|
74028783|NCT01748760|147611520|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Chi-squared|||||||.87
74028784|NCT03245814|147611521|SUPERIORITY||Odds Ratio (OR)|0.22|||<|0.001|TWO_SIDED|95.0|0.12|0.42|||Ordinal cumulative probability model|Covariates included baseline score \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.42|0.12|<.001
74028785|NCT03245814|147611522|SUPERIORITY||Odds Ratio (OR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.4|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.40|0.11|<.001
74028786|NCT03245814|147611523|SUPERIORITY||Odds Ratio (OR)|0.45||||0.02|TWO_SIDED|95.0|0.23|0.86|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.86|0.23|.02
73925111|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.33||||0.3127|TWO_SIDED|80.0|-2.18|4.84|||Mixed Models Analysis|||Change from baseline at Day 141||4.84|-2.18|0.3127
73925112|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.16||||0.5227|TWO_SIDED|80.0|-3.67|3.36|||Mixed Models Analysis|||Change from baseline at Day 141||3.36|-3.67|0.5227
73968534|NCT04359108|147475453|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.10"|||
73968535|NCT04359108|147475453|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.00"|||
73925113|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.63||||0.7643|TWO_SIDED|80.0|-4.54|1.28|||Mixed Models Analysis|||Change from baseline at Day 169||1.28|-4.54|0.7643
73968536|NCT04359108|147475453|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.88"|||
74028787|NCT03245814|147611524|SUPERIORITY||Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.13|0.5|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.50|0.13|<.001
74028788|NCT03245814|147611525|SUPERIORITY||Odds Ratio (OR)|0.34||||0.001|TWO_SIDED|95.0|0.18|0.64|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.64|0.18|.001
74028789|NCT03245814|147611526|SUPERIORITY||Odds Ratio (OR)|2.83||||0.003|TWO_SIDED|95.0|1.47|5.45|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||5.45|1.47|.003
74028790|NCT03245814|147611527|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.12|0.48|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.48|0.12|<.001
74028791|NCT03245814|147611528|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.0|7.38|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||7.38|2.00|<.001
74028792|NCT03245814|147611529|SUPERIORITY||Odds Ratio (OR)|4.49|||<|0.001|TWO_SIDED|95.0|2.28|8.83|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||8.83|2.28|<.001
74028793|NCT03245814|147611530|SUPERIORITY||Odds Ratio (OR)|3.73|||<|0.001|TWO_SIDED|95.0|1.88|7.4|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||7.40|1.88|<.001
74028794|NCT03245814|147611531|SUPERIORITY||Odds Ratio (OR)|2.33||||0.02|TWO_SIDED|95.0|1.22|4.47|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||4.47|1.22|.02
74028795|NCT03245814|147611532|SUPERIORITY||Odds Ratio (OR)|0.39||||0.009|TWO_SIDED|95.0|0.2|0.75|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.75|0.20|.009
74028796|NCT03245814|147611533|SUPERIORITY||Slope|0.42|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED||||||Mixed Models Analysis|Mixed effects regression models to account for repeated measures (multiple assessments per day) within individuals.||||||0.002
73925114|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.38||||0.7331|TWO_SIDED|80.0|-4.25|1.48|||Mixed Models Analysis|||Change from baseline at Day 169||1.48|-4.25|0.7331
73925115|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.25||||0.4557|TWO_SIDED|80.0|-2.59|3.09|||Mixed Models Analysis|||Change from baseline at Day 169||3.09|-2.59|0.4557
74087196|NCT01040793|147728343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.366|STANDARD_ERROR_OF_MEAN|0.214||0.1176||95.0|-0.757|0.085|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.085|-0.757|0.1176
73925116|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.29||||0.4549|TWO_SIDED|80.0|-2.97|3.55|||Mixed Models Analysis|||Change from baseline at Day 197||3.55|-2.97|0.4549
73925117|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.93||||0.3535|TWO_SIDED|80.0|-2.26|4.13|||Mixed Models Analysis|||Change from baseline at Day 197||4.13|-2.26|0.3535
73925118|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.65||||0.397|TWO_SIDED|80.0|-2.54|3.84|||Mixed Models Analysis|||Change from baseline at Day 197||3.84|-2.54|0.3970
73968537|NCT04359108|147475453|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.6"|||
73968538|NCT04359108|147475453|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A \*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
73968539|NCT04359108|147475453|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.10"|||
73968540|NCT04359108|147475453|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.45"|||
73968541|NCT04359108|147475453|OTHER|||||||||||||||||Navigate to Destination Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.02"|||
73925119|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.78||||0.2714|TWO_SIDED|80.0|-1.99|5.55|||Mixed Models Analysis|||Change from baseline at Day 225||5.55|-1.99|0.2714
73925120|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.72||||0.2741|TWO_SIDED|80.0|-1.97|5.41|||Mixed Models Analysis|||Change from baseline at Day 225||5.41|-1.97|0.2741
73968542|NCT04359108|147475454|OTHER|||||||0.3|||||||ANOVA|||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||0.30
73968543|NCT04359108|147475454|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
73968544|NCT04359108|147475454|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
73968545|NCT04359108|147475454|OTHER|||||||0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.01
73968546|NCT04359108|147475454|OTHER|||||||0.93|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.93
73925121|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.06||||0.5084|TWO_SIDED|80.0|-3.74|3.62|||Mixed Models Analysis|||Change from baseline at Day 225||3.62|-3.74|0.5084
73925122|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.82||||0.1537|TWO_SIDED|80.0|-0.73|6.37|||Mixed Models Analysis|||Change from baseline at Day 253||6.37|-0.73|0.1537
73925123|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.79||||0.2542|TWO_SIDED|80.0|-1.69|5.27|||Mixed Models Analysis|||Change from baseline at Day 253||5.27|-1.69|0.2542
73925124|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.03||||0.6504|TWO_SIDED|80.0|-4.46|2.4|||Mixed Models Analysis|||Change from baseline at Day 253||2.40|-4.46|0.6504
73925125|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.3||||0.3405|TWO_SIDED|80.0|-2.78|5.38|||Mixed Models Analysis|||Change from baseline at Day 281||5.38|-2.78|0.3405
73925126|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.41||||0.2194|TWO_SIDED|80.0|-1.59|6.42|||Mixed Models Analysis|||Change from baseline at Day 281||6.42|-1.59|0.2194
73968547|NCT04359108|147475454|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
73968548|NCT04359108|147475454|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.27"|||
74087197|NCT01040793|147728343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.214||0.7591||95.0|-0.486|0.355|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.355|-0.486|0.7591
73925127|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3596|TWO_SIDED|80.0|-2.87|5.09|||Mixed Models Analysis|||Change from baseline at Day 281||5.09|-2.87|0.3596
73925128|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.07||||0.5086|TWO_SIDED|80.0|-4.04|3.9|||Mixed Models Analysis|||Change from baseline at Day 309||3.90|-4.04|0.5086
73925129|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.33||||0.2211|TWO_SIDED|80.0|-1.57|6.23|||Mixed Models Analysis|||Change from baseline at Day 309||6.23|-1.57|0.2211
73925130|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.4||||0.2126|TWO_SIDED|80.0|-1.47|6.26|||Mixed Models Analysis|||Change from baseline at Day 309||6.26|-1.47|0.2126
73968549|NCT04359108|147475454|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.00"|||
74087198|NCT01040793|147728344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.094|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.234|0.094|<0.0001
73925131|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.56||||0.2053|TWO_SIDED|80.0|-1.44|6.55|||Mixed Models Analysis|||Change from baseline at Day 337||6.55|-1.44|0.2053
73925132|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.2||||0.2353|TWO_SIDED|80.0|-1.72|6.12|||Mixed Models Analysis|||Change from baseline at Day 337||6.12|-1.72|0.2353
73925133|NCT02515942|147378925|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.36||||0.5471|TWO_SIDED|80.0|-4.24|3.53|||Mixed Models Analysis|||Change from baseline at Day 337||3.53|-4.24|0.5471
73925134|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.74||||0.0913|TWO_SIDED|80.0|-5.38|-0.11|||Mixed Models Analysis|||Change from baseline at Day 2||-0.11|-5.38|0.0913
73925135|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.28||||0.4454|TWO_SIDED|80.0|-2.89|2.33|||Mixed Models Analysis|||Change from baseline at Day 2||2.33|-2.89|0.4454
73925136|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8861|TWO_SIDED|80.0|-0.16|5.08|||Mixed Models Analysis|||Change from baseline at Day 2||5.08|-0.16|0.8861
73968550|NCT04359108|147475454|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.75"|||
73968551|NCT04359108|147475454|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.60"|||
73968552|NCT04359108|147475454|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A\*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
73968553|NCT04359108|147475454|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.72"|||
73925137|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.16||||0.713|TWO_SIDED|80.0|-1.49|3.8|||Mixed Models Analysis|||Change from baseline at Day 29||3.80|-1.49|0.7130
73925138|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.37||||0.8759|TWO_SIDED|80.0|-0.26|5.01|||Mixed Models Analysis|||Change from baseline at Day 29||5.01|-0.26|0.8759
73968554|NCT04359108|147475454|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.47"|||
73968555|NCT04359108|147475454|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 3.81"|||
73862284|NCT03461406|147270488|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 4 Minutes (Parenchymous)||1.09|0.92|< 0.001
73925139|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.22||||0.7256|TWO_SIDED|80.0|-1.39|3.82|||Mixed Models Analysis|||Change from baseline at Day 29||3.82|-1.39|0.7256
73925140|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.17||||0.3111|TWO_SIDED|80.0|-4.22|1.88|||Mixed Models Analysis|||Change from baseline at Day 57||1.88|-4.22|0.3111
73925141|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.7||||0.236|TWO_SIDED|80.0|-4.73|1.34|||Mixed Models Analysis|||Change from baseline at Day 57||1.34|-4.73|0.2360
73925142|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.53||||0.411|TWO_SIDED|80.0|-3.55|2.49|||Mixed Models Analysis|||Change from baseline at Day 57||2.49|-3.55|0.4110
73925143|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.13||||0.5247|TWO_SIDED|80.0|-2.57|2.83|||Mixed Models Analysis|||Change from baseline at Day 85||2.83|-2.57|0.5247
73925144|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.37||||0.0534|TWO_SIDED|80.0|-6.04|-0.7|||Mixed Models Analysis|||Change from baseline at Day 85||-0.70|-6.04|0.0534
73925145|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.5||||0.0475|TWO_SIDED|80.0|-6.18|-0.82|||Mixed Models Analysis|||Change from baseline at Day 85||-0.82|-6.18|0.0475
73925146|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.92||||0.0575|TWO_SIDED|80.0|-7.11|-0.74|||Mixed Models Analysis|||Change from baseline at Day 113||-0.74|-7.11|0.0575
73925147|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.16||||0.1876|TWO_SIDED|80.0|-5.29|0.97|||Mixed Models Analysis|||Change from baseline at Day 113||0.97|-5.29|0.1876
73925148|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.76||||0.7644|TWO_SIDED|80.0|-1.38|4.91|||Mixed Models Analysis|||Change from baseline at Day 113||4.91|-1.38|0.7644
73925149|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.85||||0.0838|TWO_SIDED|80.0|-7.42|-0.28|||Mixed Models Analysis|||Change from baseline at Day 141||-0.28|-7.42|0.0838
73925150|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.38||||0.4444|TWO_SIDED|80.0|-3.89|3.13|||Mixed Models Analysis|||Change from baseline at Day 141||3.13|-3.89|0.4444
73968556|NCT04359108|147475455|OTHER||||||<|0.001|||||||ANOVA|navigation system mode and test block as factors||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
74087199|NCT01040793|147728344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.125|0.265|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.265|0.125|<0.0001
74087200|NCT01040793|147728345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.034||0.0245||95.0|0.01|0.146|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.146|0.010|0.0245
74028797|NCT01164501|147611541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.62|-0.39||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild or moderate renal impaired patients was the first step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal impairment and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.39|-0.62|<0.0001
74028798|NCT01164501|147611542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.72|-0.32||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild renal impaired patients was the second step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.32|-0.72|<0.0001
74028799|NCT01164501|147611542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.88|-0.49||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in mild renal impaired patients was the third step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.49|-0.88|<0.0001
74028800|NCT01164501|147611543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.56|-0.28||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in moderate renal impaired patients was the fourth step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.28|-0.56|<0.0001
74028801|NCT01004107|147611548|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
74028802|NCT01004107|147611549|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74028803|NCT01004107|147611550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74028804|NCT01004107|147611551|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74087201|NCT01040793|147728345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.105|0.24|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.240|0.105|<0.0001
74087202|NCT01040793|147728346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.074|STANDARD_ERROR_OF_MEAN|0.07||0.2897||95.0|-0.211|0.063|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.063|-0.211|0.2897
74087203|NCT01040793|147728346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.069||0.7199||95.0|-0.162|0.112|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.112|-0.162|0.7199
74087204|NCT01040793|147728347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.146||0.5313||95.0|-0.196|0.379|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.379|-0.196|0.5313
74028805|NCT01004107|147611554|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74028806|NCT01004107|147611555|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74028807|NCT00394914|147611565|SUPERIORITY_OR_OTHER|||||||0.973|||||||Cochran-Mantel-Haenszel|||||||0.973
74028808|NCT00394914|147611566|SUPERIORITY_OR_OTHER|||||||0.425|||||||Cochran-Mantel-Haenszel|||||||0.425
74028809|NCT00872898|147611595|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.2||||0.1197|TWO_SIDED|95.0|-4.9|0.6|||mixed-model for repeated measures|||||0.6|-4.9|0.1197
74028810|NCT00872898|147611596|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.9781|TWO_SIDED|95.0|-7.2|7.0|||mixed-model for repeated measures|||||7.0|-7.2|0.9781
74028811|NCT00872898|147611597|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4||||0.1459|TWO_SIDED|95.0|-3.2|0.5|||mixed-model for repeated measures|||||0.5|-3.2|0.1459
74028812|NCT00872898|147611598|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.8||||0.1344|TWO_SIDED|95.0|-1.9|0.3|||mixed-model for repeated measures|||||0.3|-1.9|0.1344
74028813|NCT00872898|147611599|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.7|TWO_SIDED|95.0|-1.5|1.0|||mixed-model for repeated measures|||||1.0|-1.5|0.7000
74028814|NCT00872898|147611600|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.9069|TWO_SIDED|95.0|-1.3|1.1|||mixed-model for repeated measures|||||1.1|-1.3|0.9069
74028815|NCT00872898|147611601|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.3||||0.4679|TWO_SIDED|95.0|-1.2|0.6|||mixed-model for repeated measures|||||0.6|-1.2|0.4679
74028816|NCT00872898|147611602|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9598|TWO_SIDED|95.0|-1.3|1.3|||mixed-model for repeated measures|||||1.3|-1.3|0.9598
74028817|NCT00872898|147611603|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9898|TWO_SIDED|95.0|-1.3|1.3|||mixed-model for repeated measures|||||1.3|-1.3|0.9898
74028818|NCT00872898|147611604|SUPERIORITY_OR_OTHER||Least squares mean difference|0.5||||0.4228|TWO_SIDED|95.0|-0.7|1.6|||mixed-model for repeated measures|||||1.6|-0.7|0.4228
74028819|NCT00872898|147611605|SUPERIORITY_OR_OTHER||Least squares mean difference|1.4||||0.0201|TWO_SIDED|95.0|0.2|2.5|||mixed-model for repeated measures|||||2.5|0.2|0.0201
74028820|NCT00872898|147611606|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.6889|TWO_SIDED|95.0|-1.3|0.9|||mixed-model for repeated measures|||||0.9|-1.3|0.6889
74087205|NCT01040793|147728347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.341|STANDARD_ERROR_OF_MEAN|0.146||0.0198||95.0|0.055|0.628|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.628|0.055|0.0198
74087206|NCT01040793|147728348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.053||0.1048||95.0|-0.19|0.018|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.018|-0.190|0.1048
74087207|NCT01040793|147728348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.053||0.0246||95.0|-0.224|-0.015|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.015|-0.224|0.0246
73925151|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.47||||0.8977|TWO_SIDED|80.0|-0.04|6.97|||Mixed Models Analysis|||Change from baseline at Day 141||6.97|-0.04|0.8977
73925152|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4917|TWO_SIDED|80.0|-2.92|2.82|||Mixed Models Analysis|||Change from baseline at Day 169||2.82|-2.92|0.4917
73925153|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4909|TWO_SIDED|80.0|-2.89|2.79|||Mixed Models Analysis|||Change from baseline at Day 169||2.79|-2.89|0.4909
73925154|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.4992|TWO_SIDED|80.0|-2.82|2.81|||Mixed Models Analysis|||Change from baseline at Day 169||2.81|-2.82|0.4992
73925155|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.09||||0.3285|TWO_SIDED|80.0|-4.25|2.07|||Mixed Models Analysis|||Change from baseline at Day 197||2.07|-4.25|0.3285
73925156|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.45||||0.1568|TWO_SIDED|80.0|-5.57|0.67|||Mixed Models Analysis|||Change from baseline at Day 197||0.67|-5.57|0.1568
73925157|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.36||||0.2867|TWO_SIDED|80.0|-4.46|1.74|||Mixed Models Analysis|||Change from baseline at Day 197||1.74|-4.46|0.2867
73968557|NCT04359108|147475455|OTHER||||||<|0.01|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
73968558|NCT04359108|147475455|OTHER|||||||0.037||||||within-participant, 2 sided t-test|t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.037
73862285|NCT03461406|147270488|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8|Relative risk|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.16|||Cochran-Mantel-Haenszel|||Hemostasis by 4 Minutes (Soft Tissue)||1.16|0.91|< 0.001
73925158|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.93||||0.0798|TWO_SIDED|80.0|-7.51|-0.35|||Mixed Models Analysis|||Change from baseline at Day 225||-0.35|-7.51|0.0798
73925159|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.47||||0.2962|TWO_SIDED|80.0|-5.0|2.06|||Mixed Models Analysis|||Change from baseline at Day 225||2.06|-5.00|0.2962
73968559|NCT04359108|147475455|OTHER|||||||0.34|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.34
73968560|NCT04359108|147475455|OTHER|||||||0.1|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||0.10
73968561|NCT04359108|147475455|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
73968562|NCT04359108|147475455|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
73968563|NCT04359108|147475455|OTHER|||||||0.67|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.67
73968564|NCT04359108|147475455|OTHER|||||||0.23|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.23
73968565|NCT04359108|147475455|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
73968566|NCT04359108|147475455|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.79"|||
74087208|NCT01040793|147728349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.318|-0.108|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.108|-0.318|<0.0001
74087209|NCT01040793|147728349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.187|STANDARD_ERROR_OF_MEAN|0.054||0.0005||95.0|-0.293|-0.082|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.082|-0.293|0.0005
74087210|NCT01040793|147728350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|0.071|0.228|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.228|0.071|0.0002
73925160|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8163|TWO_SIDED|80.0|-1.05|5.98|||Mixed Models Analysis|||Change from baseline at Day 225||5.98|-1.05|0.8163
73925161|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.64||||0.0708|TWO_SIDED|80.0|-6.81|-0.47|||Mixed Models Analysis|||Change from baseline at Day 253||-0.47|-6.81|0.0708
73925162|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.575|TWO_SIDED|80.0|-2.67|3.59|||Mixed Models Analysis|||Change from baseline at Day 253||3.59|-2.67|0.5750
73925163|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.1||||0.956|TWO_SIDED|80.0|1.03|7.17|||Mixed Models Analysis|||Change from baseline at Day 253||7.17|1.03|0.9560
73925164|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.22||||0.1283|TWO_SIDED|80.0|-6.86|0.42|||Mixed Models Analysis|||Change from baseline at Day 281||0.42|-6.86|0.1283
73925165|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.28||||0.2085|TWO_SIDED|80.0|-5.88|1.33|||Mixed Models Analysis|||Change from baseline at Day 281||1.33|-5.88|0.2085
73925166|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.94||||0.6335|TWO_SIDED|80.0|-2.61|4.49|||Mixed Models Analysis|||Change from baseline at Day 281||4.49|-2.61|0.6335
73925167|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.64||||0.1778|TWO_SIDED|80.0|-6.31|1.03|||Mixed Models Analysis|||Change from baseline at Day 309||1.03|-6.31|0.1778
73925168|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.7||||0.4027|TWO_SIDED|80.0|-4.33|2.94|||Mixed Models Analysis|||Change from baseline at Day 309||2.94|-4.33|0.4027
73925169|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.94||||0.757|TWO_SIDED|80.0|-1.64|5.53|||Mixed Models Analysis|||Change from baseline at Day 309||5.53|-1.64|0.7570
74028821|NCT00872898|147611607|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||0.7481|TWO_SIDED|95.0|-0.9|1.2|||mixed-model for repeated measures|||||1.2|-0.9|0.7481
74028822|NCT00872898|147611608|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.95|TWO_SIDED|95.0|-1.2|1.1|||mixed-model for repeated measures|||||1.1|-1.2|0.9500
74028823|NCT00044044|147611614|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
74028824|NCT00044044|147611615|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
74028825|NCT00044044|147611616|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
74028826|NCT00044044|147611617|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
74028827|NCT02179398|147611628|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Chi-squared|||||||1
74028828|NCT02179398|147611629|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Chi-squared|||||||1
74028829|NCT02179398|147611630|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|95.0|||||Chi-squared|||Power calculation suggested 97 patients should be enrolled in each group to give 80% power at the 5% level of significance to detect a 20% difference in antibiotic prescription rate||||0.810
74087211|NCT01040793|147728350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.04||0.0001||95.0|0.076|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.233|0.076|0.0001
73925170|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.9||||0.1132|TWO_SIDED|80.0|-8.03|0.23|||Mixed Models Analysis|||Change from baseline at Day 337||0.23|-8.03|0.1132
73925171|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.71||||0.1965|TWO_SIDED|80.0|-6.8|1.37|||Mixed Models Analysis|||Change from baseline at Day 337||1.37|-6.80|0.1965
73968567|NCT04359108|147475455|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.38"|||
73968568|NCT04359108|147475455|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.24"|||
74087212|NCT01040793|147728351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.162|0.303|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.303|0.162|<0.0001
73968569|NCT04359108|147475455|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.85"|||
73968570|NCT04359108|147475455|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A\*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
73968571|NCT04359108|147475455|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.18"|||
73968572|NCT04359108|147475455|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.97"|||
73968573|NCT04359108|147475455|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.23"|||
73968574|NCT04359108|147475456|OTHER||||||<|0.001|||||||ANOVA|Single-factor test on navigation system mode||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
74087213|NCT01040793|147728351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.133|0.273|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.273|0.133|<0.0001
74087214|NCT01040793|147728352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.056||0.3109||95.0|-0.053|0.166|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.166|-0.053|0.3109
74087215|NCT01040793|147728352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.056||0.608||95.0|-0.081|0.138|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.138|-0.081|0.6080
73968575|NCT04359108|147475456|OTHER|||||||0.17|||||||t-test, 2 sided|||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||0.17
73968576|NCT04359108|147475456|OTHER||||||<|0.01|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||<0.01
73968577|NCT04359108|147475456|OTHER|||||||0.33|||||||t-test, 2 sided|||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.33
74087216|NCT01040793|147728353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.056||0.6809||95.0|-0.087|0.133|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.133|-0.087|0.6809
73925172|NCT02515942|147378926|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.18||||0.6471|TWO_SIDED|80.0|-2.85|5.21|||Mixed Models Analysis|||Change from baseline at Day 337||5.21|-2.85|0.6471
73925173|NCT02310919|147378935|NON_INFERIORITY|For the non-inferiority hypothesis testing of the primary outcome, a one-sided 95% CI was constructed for the relative risk. The alternative trigger will be considered non-inferior to the standard trigger if the lower bound of the one-sided CI of the relative risk is not less than 0.8 (i.e. risk reduction limit of 20%).|Risk Ratio (RR)|0.91|||||ONE_SIDED|95.0|0.83|||Using the standard trigger as the reference, the relative risk (i.e. risk ratio) (RR) with 95% confidence interval (CI) for the probability of the outcome was calculated using log-binomial regression models with application of GEE.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The alternative trigger will be considered non-inferior to the standard hCG trigger if it is at least 80% as effective at inducing oocyte competence. Considering a cluster size of 15 oocytes and an estimated intra-cluster correlation of 0.1, we calculated that approximately 50 participants were needed in each study arm when the non-inferiority difference is -0.1 (i.e. 20% of 0.5 total competent proportion) with a power of 0.8 and a one-sided alpha of 0.05.|||0.83|
73925174|NCT02310919|147378936|SUPERIORITY||Risk Ratio (RR)|0.85||||0.06|TWO_SIDED|95.0|0.71|1.01||The statistical significance was based on a two-sided alpha of 0.05.|generalized linear model with log link|Comparison was done using generalized linear modeling with log link function|The numerator was the outcome with the alternative trigger, and the denominator was the outcome with the standard trigger.|The null hypothesis was that there would be no difference in number of oocytes retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.01|0.71|0.06
73925175|NCT02310919|147378937|SUPERIORITY||Risk Ratio (RR)|0.87||||0.13|TWO_SIDED|95.0|0.72|1.04||The statistical significance was based on a two-sided alpha of 0.05.|generalized linear model with log link|Comparison was done using generalized linear modeling with log link function.|The numerator was the outcome with the alternative trigger, and the denominator was the outcome with the standard trigger.|The null hypothesis was that there would be no difference in the number of MII oocytes retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.04|0.72|0.13
73925176|NCT02310919|147378938|SUPERIORITY||Risk Ratio (RR)|0.97||||0.47|TWO_SIDED|95.0|0.9|1.05||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in oocyte maturity rate retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.05|0.90|0.47
73925177|NCT02310919|147378939|SUPERIORITY||Risk Ratio (RR)|0.88||||0.01|TWO_SIDED|95.0|0.76|0.97||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|||0.97|0.76|0.01
73925178|NCT02310919|147378940|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.9|1.1||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in ICSI fertilization rate retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.10|0.90|0.95
73925179|NCT02310919|147378941|SUPERIORITY||Risk Ratio (RR)|0.95||||0.52|TWO_SIDED|95.0|0.81|1.12||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in the percentage of high quality cleavage-stage embryos between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.12|0.81|0.52
73925180|NCT02310919|147378942|SUPERIORITY||Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.84|1.16||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|||1.16|0.84|0.87
73925181|NCT02310919|147378943|SUPERIORITY||Risk Ratio (RR)|1.01||||1|TWO_SIDED|95.0|0.59|1.74||The statistical significance was based on a two-sided alpha of 0.05.|Fisher Exact||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in livebirths in fresh transfers between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.74|0.59|1.0
73925182|NCT02310919|147378944|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in bloating scores from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.98
73925183|NCT02310919|147378945|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in abdominal circumference from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.39
74087217|NCT01040793|147728353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.858||95.0|-0.1|0.12|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.120|-0.100|0.8580
73925184|NCT02310919|147378946|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in body weight from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.41
73925185|NCT02310919|147378947|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73925186|NCT02310919|147378948|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73925187|NCT02310919|147378949|SUPERIORITY|||||||0.08||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.08
73925188|NCT02310919|147378950|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73925189|NCT02310919|147378951|SUPERIORITY|||||||0.67||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.67
73925190|NCT02310919|147378952|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73925191|NCT02310919|147378953|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73925192|NCT02310919|147378954|SUPERIORITY|||||||0.49||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.49
73925193|NCT02310919|147378955|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73968578|NCT04359108|147475456|OTHER||||||<|0.01|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
73862286|NCT03461406|147270489|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 7 Minutes (Parenchymous)||1.09|0.92|< 0.001
73925194|NCT02310919|147378956|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73925195|NCT02310919|147378957|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73925196|NCT02310919|147378958|SUPERIORITY|||||||0.16||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.16
73925197|NCT02310919|147378959|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73925198|NCT02310919|147378960|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73925199|NCT02310919|147378961|SUPERIORITY|||||||0.95||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.95
73925200|NCT02310919|147378962|SUPERIORITY|||||||0.07||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.07
73925201|NCT02310919|147378963|SUPERIORITY|||||||0.66||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.66
73925202|NCT02436759|147378964|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Two-sided t-test with treatment as a fixed factor and baseline score as a covariate||||||<0.0001
73925203|NCT02436759|147378965|SUPERIORITY|||||||0.12|||||||ANCOVA|Two-sided t-test||||||0.12
73925204|NCT00277212|147378966|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.552||||0.058|TWO_SIDED|95.0|0.296|1.03||stratified Log-Rank test, controlling for type of index mood episode|Log Rank||Cox's proportional hazards model, with type of index modd episode as stratification factor, and randomized treatment group as covariate.|||1.030|0.296|0.058
73925205|NCT00277212|147378967|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.671||||0.055|TWO_SIDED|95.0|0.446|1.011||p-value for equality of survival curves|Log Rank|stratified log-rank test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.011|0.446|0.055
73925206|NCT00277212|147378968|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.784||||0.381|TWO_SIDED|95.0|0.454|1.354||p-value for equality of survival curves|Log Rank|stratified log-rank test, conrolling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.354|0.454|0.381
73925207|NCT00277212|147378969|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.871||||0.295|TWO_SIDED|95.0|0.672|1.128||p-value for equality of survival curves|Log Rank|stratified Log-Rank Test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.128|0.672|0.295
73925208|NCT00277212|147378971|SUPERIORITY_OR_OTHER||Treatement Difference|2.24||||0.001|TWO_SIDED|95.0|0.91|3.57||ANOVA (main effects=double-blind treatment, covariate=index mood episode) used for baseline comparisons. ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons|ANCOVA||Aripiprazole vs. placebo|Week 52 LOCF||3.57|0.91|0.001
73925209|NCT00277212|147378972|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.56||||0.073|TWO_SIDED|95.0|0.29|1.07|||Cochran-Mantel-Haenszel||aripiprazole/placebo|Week 52 LOCF||1.07|0.29|0.073
73925210|NCT00277212|147378972|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||Cochran-Mantel-Haenszel|||At Any Time||||0.194
73925211|NCT00277212|147378973|SUPERIORITY_OR_OTHER||relative risk|3.41||||0.007|TWO_SIDED|95.0|1.3|8.94|||Cochran-Mantel-Haenszel|||Week 52 LOCF||8.94|1.30|0.007
73925212|NCT00277212|147378973|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
73968579|NCT04359108|147475457|OTHER|||||||0.023|||||||ANOVA|2X2 within-participant test with factors of resolution and field-of-view||Significance of Resolution: test for null hypothesis of equivalent performance between low and high resolution vision modes||||0.023
73968580|NCT04359108|147475457|OTHER|||||||0.039|||||||ANOVA|2X2 within-participant test with factors of resolution and field-of-view||Significance of Resolution: test for null hypothesis of equivalent performance between low and high field-of-view vision modes||||0.039
73968581|NCT04359108|147475457|OTHER|||||||0.801|||||||ANOVA|2x2 within-participant test with factors of resolution and field-of-view||Significance of Interaction between Resolution and Field-of-View: test for null hypothesis of no interaction||||.801
73925213|NCT00277212|147378974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.467|TWO_SIDED|95.0|-2.37|1.09||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA model, with double-blind treatment as main effects and index mood episode as covariate, is used for Baseline comparisons.|aripiprazole - placebo|Baseline||1.09|-2.37|0.467
73925214|NCT00277212|147378974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|95.0|-0.06|0.78||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 12||0.78|-0.06|
73925215|NCT00277212|147378974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||||TWO_SIDED|95.0|0.19|1.3||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||1.30|0.19|
73925216|NCT00277212|147378974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|||||TWO_SIDED|95.0|0.08|1.86||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 36||1.86|0.08|
73925217|NCT00277212|147378974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|-0.08|1.92||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||1.92|-0.08|
73925218|NCT00277212|147378974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.001|TWO_SIDED|95.0|0.31|1.26||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)||1.26|0.31|0.001
73925219|NCT00277212|147378974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.002|TWO_SIDED|95.0|0.23|1.04||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from baseline||1.04|0.23|0.002
73925220|NCT00277212|147378980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.971|TWO_SIDED|95.0|-0.35|0.34||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, with double-blind treatment as main effects, is used for Baseline comparisons.|aripiprazole - placebo|Baseline||0.34|-0.35|0.971
73925221|NCT00277212|147378980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.03|0.51||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 8||0.51|-0.03|
73925222|NCT00277212|147378980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.13|0.6||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||0.60|-0.13|
73971407|NCT04508309|147483472|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.68|||||TWO_SIDED|98.3|1.372|2.069|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.069|1.372|
74087218|NCT01040793|147728354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.148|0.073|<0.0001
73925223|NCT00277212|147378980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.06|0.55||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 36||0.55|-0.06|
73925224|NCT00277212|147378980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||||TWO_SIDED|95.0|-0.06|0.65||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||0.65|-0.06|
74087219|NCT01040793|147728354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.148|0.073|<0.0001
73862287|NCT03461406|147270489|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 7 Minutes (Soft tissue)||1.09|0.92|< 0.001
73925225|NCT00277212|147378980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.095|TWO_SIDED|95.0|-0.04|0.52||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)||0.52|-0.04|0.095
74028830|NCT02519231|147611710|SUPERIORITY||Mean Difference (Net)|-1.76|STANDARD_ERROR_OF_MEAN|5.0||0.11|TWO_SIDED|95.0||||The threshold for statistical significance was p =0.05|t-test, 2 sided|For days with bleeding/spotting outcomes, we used independent t-tests to compare the unadjusted mean difference between groups.|Treatment Difference = Naproxen - Placebo|We originally planned to enroll 60 subjects based on other similar studies that evaluated treatment for bleeding among women using contraception; as reported by Cohen et al., a sample size of 42 provided 80% power to detect a difference of 7 bleeding/spotting days in 30 days by two-sample t-test, allowing for an expected 20% drop-out.|We designed the study to include another site, in addition to the UW site enrolled participants. After 6 months of failed active recruitment at the other site, we discontinued that site from the study. Resources did not permit us to contract with an alternative recruitment site, and thus the protocol was revised to enroll 32 participants at the Seattle site only.|||.11
73925226|NCT00277212|147378980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.061|TWO_SIDED|95.0|-0.01|0.63||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripirazole - placebo|Highest change from Baseline||0.63|-0.01|0.061
73925227|NCT00277212|147378981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.458||95.0|-0.25|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, controlling for treatment, is used for baseline estimates.|aripiprazole - placebo|Baseline||0.11|-0.25|0.458
73925228|NCT00277212|147378981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.05|0.26||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 8||0.26|-0.05|
73925229|NCT00277212|147378981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.11|0.2||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||0.20|-0.11|
73925230|NCT00277212|147378981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|0.0|0.42||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 36||0.42|0.00|
73925231|NCT00277212|147378981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.05|0.16||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at week 52||0.16|-0.05|
74028831|NCT02519231|147611711|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
74028832|NCT01707147|147611730|OTHER||Mean Difference (Final Values)|-0.77|STANDARD_DEVIATION|1.5|<|0.0001|TWO_SIDED|95.0|-0.83|-0.71|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.|||-0.71|-0.83|<0.0001
73862288|NCT03461406|147270490|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.|Relative risk|0.98|||<|0.001|TWO_SIDED|95.0|0.94|1.02|||Cochran-Mantel-Haenszel|||Hemostasis by 10 Minutes (Parenchymous)||1.02|0.94|< 0.001
73925232|NCT00277212|147378981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.515|TWO_SIDED|95.0|-0.22|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)||0.11|-0.22|0.515
73925233|NCT00277212|147378981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.73|TWO_SIDED|95.0|-0.16|0.23||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline||0.23|-0.16|0.730
73925234|NCT00277212|147378982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.435|TWO_SIDED|95.0|-0.08|0.2||Means, mean differences, 95% confidence intervals for the differences, and the p-values are based on ANOVA/ANCOVA model.|ANOVA|ANOVA, controlling for treatment, used for baseline estimates.|aripiprazole - placebo|Baseline||0.20|-0.08|0.435
74028833|NCT01707147|147611733|OTHER||Mean Difference (Final Values)|-18.05|STANDARD_DEVIATION|61.84|<|0.0001|TWO_SIDED|95.0|-20.98|-15.12|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.|||-15.12|-20.98|<0.0001
74028834|NCT03320512|147611746|SUPERIORITY||Average Treatment Effect|0.15||||0.04965|TWO_SIDED|95.0|0.0|0.29|||TMLE estimation of ATE and Wald test|Targeted Maximum Likelihood Estimation (TMLE) Average Treatment Effect (ATE)||Month 3 The analysis includes the intent-to-treat population||0.29|0.00|0.04965
73925235|NCT00277212|147378982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|0.04|0.3||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 8||0.30|0.04|
73925236|NCT00277212|147378982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.11|0.17||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 24||0.17|-0.11|
73925237|NCT00277212|147378982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.13|0.13||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 36||0.13|-0.13|
73925238|NCT00277212|147378982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.08|0.14||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||0.14|-0.08|
73925239|NCT00277212|147378982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.358|TWO_SIDED|95.0|-0.06|0.17||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)||0.17|-0.06|0.358
73925240|NCT00277212|147378982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.021|TWO_SIDED|95.0|0.03|0.31||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline||0.31|0.03|0.021
73925241|NCT03336216|147378992|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|60.0|1.19|1.82||||||||1.82|1.19|
73925242|NCT03336216|147378992|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|60.0|0.77|1.3||||||||1.30|0.77|
73925243|NCT03336216|147378992|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|60.0|0.6|1.03||||||||1.03|0.60|
73925244|NCT03336216|147378993|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|60.0|1.33|2.02||||||||2.02|1.33|
74028835|NCT03320512|147611746|SUPERIORITY||Average Treatment Effect|-0.04||||0.62|TWO_SIDED|95.0|-0.21|0.13|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population||0.13|-0.21|0.62
74087220|NCT01040793|147728355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.151|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.233|0.151|<0.0001
73862289|NCT03461406|147270490|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 10 Minutes (Soft tissue)||1.09|0.92|< 0.001
73925245|NCT03336216|147378993|SUPERIORITY||Hazard Ratio (HR)|1.13||||||60.0|0.87|1.46||||||||1.46|0.87|
73925246|NCT03336216|147378993|SUPERIORITY||Hazard Ratio (HR)|0.72||||||60.0|0.55|0.94||||||||0.94|0.55|
73925247|NCT03336216|147378996|SUPERIORITY||Strata adjusted difference|1.8||||0.6537||95.0|-5.5|9.0||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||9.0|-5.5|0.6537
73925248|NCT03336216|147378996|SUPERIORITY||Strata adjusted difference|12.5||||0.0951||95.0|3.1|21.9||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||21.9|3.1|0.0951
73925249|NCT03336216|147378996|SUPERIORITY||Strata adjusted difference|5.0||||0.5171||95.0|-8.0|18.1||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||18.1|-8.0|0.5171
73925250|NCT03336216|147378997|SUPERIORITY||Strata adjusted difference|-0.8||||0.8505|TWO_SIDED|95.0|-9.4|7.7||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||7.7|-9.4|0.8505
73925251|NCT03336216|147378997|SUPERIORITY||Strata adjusted difference|1.5||||0.8144|TWO_SIDED|95.0|-9.9|12.8||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||12.8|-9.9|0.8144
73925252|NCT03336216|147378997|SUPERIORITY||Strata adjusted difference|0.7||||0.9087|TWO_SIDED|95.0|-10.7|12.1||Stratified CMH test stratified by ECOG and prior chemotherapy.|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||12.1|-10.7|0.9087
73925253|NCT03336216|147379000|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.76|1.96|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.96|0.76|
74028836|NCT03320512|147611747|SUPERIORITY||Average Treatment Effect|0.12||||0.11|TWO_SIDED|95.0|-0.03|0.26|||TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population||0.26|-0.03|0.11
74028837|NCT03320512|147611747|SUPERIORITY||Average Treatment Effect|0.06||||0.38|TWO_SIDED|95.0|-0.08|0.21|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population||0.21|-0.08|0.38
74087221|NCT01040793|147728355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.153|0.236|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.236|0.153|<0.0001
73862290|NCT00973102|147270496|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.47||||0.252|TWO_SIDED|95.0|1.16|5.25|||Barnard's unconditional Exact Test|||||5.25|1.16|.252
74087222|NCT01040793|147728356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.036||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.191|0.047|0.0013
74028838|NCT03320512|147611748|SUPERIORITY||Average Treatment Effect|0.04||||0.68|TWO_SIDED|95.0|-0.09|0.16||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.16|-0.09|0.68
74028839|NCT03320512|147611748|SUPERIORITY||Average Treatment Effect|0.11||||0.53|TWO_SIDED|95.0|-0.03|0.25||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.25|-0.03|0.53
74087223|NCT01040793|147728356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.191|0.047|0.0013
73925254|NCT03336216|147379000|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.59|1.86|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.86|0.59|
73925255|NCT03336216|147379000|SUPERIORITY||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.45|1.46|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.46|0.45|
73925256|NCT01231581|147379028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.352|TWO_SIDED|95.0|0.66|1.32|||Log Rank||Hazard ratios are estimated using a Pike estimator.|||1.32|0.66|0.352
73925257|NCT03616912|147379035|SUPERIORITY||Odds Ratio (OR)|1.57||||0.016|TWO_SIDED|95.0|1.09|2.27|||Regression, Logistic|||||2.27|1.09|0.016
73925258|NCT03616912|147379036|SUPERIORITY||Odds Ratio (OR)|1.14||||0.47|TWO_SIDED|95.0|0.79|1.65|||Regression, Logistic|||||1.65|0.79|0.470
73925259|NCT03616912|147379037|SUPERIORITY||Odds Ratio (OR)|0.96||||0.839|TWO_SIDED|95.0|0.63|1.45|||Regression, Logistic|||||1.45|0.63|0.839
74028840|NCT03320512|147611749|SUPERIORITY||Average Treatment Effect|0.06||||0.53|TWO_SIDED|95.0|-0.02|0.15||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.15|-0.02|0.53
74028841|NCT03320512|147611749|SUPERIORITY||Average Treatment Effect|0.0||||0.96|TWO_SIDED|95.0|-0.12|0.12||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.12|-0.12|0.96
74028842|NCT03320512|147611750|SUPERIORITY||Average Treatment Effect|0.08||||0.93|TWO_SIDED|95.0|-0.84|1.0||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.00|-0.84|0.93
74028843|NCT03320512|147611750|SUPERIORITY||Average Treatment Effect|-1.12||||0.6|TWO_SIDED|95.0|-4.16|1.91||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.91|-4.16|0.60
74028844|NCT03320512|147611751|SUPERIORITY||Average Treatment Effect|0.73||||0.6|TWO_SIDED|95.0|-1.03|2.48||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||2.48|-1.03|0.60
74087224|NCT01040793|147728357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.196|0.333|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.333|0.196|<0.0001
73862291|NCT00973102|147270497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.895|||||||t-test, 2 sided|||||||.895
74087225|NCT01040793|147728357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.350|0.212|<0.0001
73925260|NCT03616912|147379037|SUPERIORITY||Odds Ratio (OR)|1.19||||0.391|TWO_SIDED|95.0|0.8|1.79|||Regression, Logistic|||||1.79|0.80|0.391
73925261|NCT03616912|147379039|SUPERIORITY||Odds Ratio (OR)|0.94||||0.82|TWO_SIDED|95.0|0.53|1.66|||Regression, Logistic|||||1.66|0.53|0.820
73925262|NCT03616912|147379039|SUPERIORITY||Odds Ratio (OR)|1.18||||0.565|TWO_SIDED|95.0|0.67|2.08|||Regression, Logistic|||||2.08|0.67|0.565
73925263|NCT03616912|147379040|SUPERIORITY||LS Mean Difference Final Values|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.598|TWO_SIDED|95.0|-0.52|0.3|||Mixed Models Analysis|||||0.30|-0.52|0.598
73925264|NCT03616912|147379040|SUPERIORITY||LS Mean Difference Final Values|-0.09|STANDARD_ERROR_OF_MEAN|0.21||0.674|TWO_SIDED|95.0|-0.5|0.32|||Mixed Models Analysis|||||0.32|-0.50|0.674
73925265|NCT03616912|147379041|SUPERIORITY||LS Mean Difference Final Values|0.02|STANDARD_ERROR_OF_MEAN|0.85||0.979|TWO_SIDED|95.0|-1.65|1.7|||Mixed Models Analysis|||||1.70|-1.65|0.979
73925266|NCT03616912|147379041|SUPERIORITY||LS Mean Difference Final Values|-0.36|STANDARD_ERROR_OF_MEAN|0.86||0.678|TWO_SIDED|95.0|-2.03|1.32|||Mixed Models Analysis|||||1.32|-2.03|0.678
73925267|NCT03616912|147379042|SUPERIORITY||Odds Ratio (OR)|1.02||||0.965|TWO_SIDED|95.0|0.43|2.42|||Regression, Logistic|||||2.42|0.43|0.965
73925268|NCT03616912|147379042|SUPERIORITY||Odds Ratio (OR)|1.22||||0.661|TWO_SIDED|95.0|0.51|2.92|||Regression, Logistic|||||2.92|0.51|0.661
73925269|NCT03616912|147379043|SUPERIORITY||LS Mean Difference Final Values|0.24|STANDARD_ERROR_OF_MEAN|0.43||0.578|TWO_SIDED|95.0|-0.61|1.08|||Mixed Models Analysis|||||1.08|-0.61|0.578
73925270|NCT03616912|147379043|SUPERIORITY||LS Mean Difference Final Values|-0.44|STANDARD_ERROR_OF_MEAN|0.433||0.309|TWO_SIDED|95.0|-1.29|0.41|||Mixed Models Analysis|||||0.41|-1.29|0.309
73925271|NCT03616912|147379044|SUPERIORITY||LS Mean Difference Final Values|-0.29|STANDARD_ERROR_OF_MEAN|0.277||0.287|TWO_SIDED|95.0|-0.84|0.25|||Mixed Models Analysis|||||0.25|-0.84|0.287
73925272|NCT03616912|147379044|SUPERIORITY||LS Mean Difference Final Values|-0.44|STANDARD_ERROR_OF_MEAN|0.278||0.113|TWO_SIDED|95.0|-0.99|0.11|||Mixed Models Analysis|||||0.11|-0.99|0.113
73925273|NCT01649375|147379060|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0967|TWO_SIDED|95.0|0.9|3.67|||Regression, Logistic|Missing ASAS responses considered nonresponders||||3.67|0.90|0.0967
73925274|NCT01649375|147379060|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.0001|TWO_SIDED|95.0|2.14|8.96|||Regression, Logistic|Missing ASAS responses considered nonresponders||||8.96|2.14|<.0001
73925275|NCT01649375|147379061|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0194|TWO_SIDED|95.0|1.19|7.48|||Regression, Logistic|Missing ASAS responses considered nonresponders||||7.48|1.19|0.0194
73925276|NCT01649375|147379061|SUPERIORITY||Odds Ratio (OR)|5.07|||<|0.0004|TWO_SIDED|95.0|2.06|12.44|||Regression, Logistic|Missing ASAS responses considered nonresponders||||12.44|2.06|<.0004
73925277|NCT01649375|147379062|SUPERIORITY||Mean Difference (Net)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.71|||Mixed Models Analysis|||||0.71|0.41|<0.0001
73925278|NCT01649375|147379062|SUPERIORITY||Mean Difference (Net)|0.49|||<|0.0001|TWO_SIDED|95.0|0.37|0.64|||Mixed Models Analysis|||||0.64|0.37|<0.0001
73925279|NCT01649375|147379063|SUPERIORITY||Odds Ratio (OR)|6.13||||0.0003|TWO_SIDED|95.0|2.31|16.26|||Regression, Logistic|Missing ASAS responses considered nonresponders||||16.26|2.31|0.0003
73925280|NCT01649375|147379063|SUPERIORITY||Odds Ratio (OR)|9.15|||<|0.0001|TWO_SIDED|95.0|3.47|24.12|||Regression, Logistic|Missing ASAS responses considered nonresponders||||24.12|3.47|<.0001
73925281|NCT01649375|147379064|SUPERIORITY||Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|0.353|<|0.0001|TWO_SIDED|95.0|-1.77|-0.37|||Mixed Models Analysis|||||-0.37|-1.77|<0.0001
73925282|NCT01649375|147379064|SUPERIORITY||Mean Difference (Net)|-1.34|STANDARD_ERROR_OF_MEAN|0.353||0.0002|TWO_SIDED|95.0|-2.04|-0.65|||Mixed Models Analysis|||||-0.65|-2.04|0.0002
73925283|NCT01649375|147379065|SUPERIORITY||Mean Difference (Net)|2.84|STANDARD_ERROR_OF_MEAN|1.108||0.011|TWO_SIDED|95.0|0.66|5.03|||Mixed Models Analysis|||||5.03|0.66|0.0110
73968582|NCT06393088|147475474|SUPERIORITY|It was calculated that 24 participants randomized 1:1 between 2 arms would have at least an 85% power to detect a difference in pain relief of 30 points as measured using a Visual Analog Device. The actual difference in the mean of the change in pain level, as measured using a Visual Analog Scale, between the two independent groups is 41.67. Results of the post trial calculation was a 95.7% power to detect the difference in pain relief using 29 randomized participants.|Mean Difference (Net)|41.67|||<|0.01|TWO_SIDED|95.0|20.15|61.67||The threshold is P-value \<.0.05 for statistical significance A bootstrap N=20,000 was used for all estimates|t-test, 2 sided|||"Null Hypothesis:~There is not a statistically significant difference in nociceptive musculoskeletal pain when using an IR REHAB device when compared with a sham (placebo) device as a therapy in an approved and standardized clinical protocol."||61.67|20.15|<0.01
73968583|NCT02515773|147475475|SUPERIORITY||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|||||This is a calculated p-value less than 0.001|ANCOVA|||||||<0.001
73968584|NCT02515773|147475476|SUPERIORITY||Mean Difference (Net)|0.07||||0.044|TWO_SIDED||||||ANCOVA|||||||0.044
73925284|NCT01649375|147379065|SUPERIORITY||Mean Difference (Net)|4.14|STANDARD_ERROR_OF_MEAN|1.105||0.0002|TWO_SIDED|95.0|1.96|6.32|||Mixed Models Analysis|||||6.32|1.96|0.0002
73925285|NCT01649375|147379066|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.748||0.0096|TWO_SIDED|95.0|-3.43|-0.48|||Mixed Models Analysis|||||-0.48|-3.43|0.0096
73925286|NCT01649375|147379066|SUPERIORITY||Mean Difference (Net)|-2.63|STANDARD_ERROR_OF_MEAN|0.743||0.0005|TWO_SIDED|95.0|-4.09|-1.16|||Mixed Models Analysis|||||-1.16|-4.09|0.0005
73925287|NCT01649375|147379067|SUPERIORITY||Odds Ratio (OR)|4.28||||0.0325|TWO_SIDED|95.0|1.13|16.21|||Regression, Logistic|Missing ASAS responses considered nonresponders||||16.21|1.13|0.0325
73925288|NCT01649375|147379067|SUPERIORITY||Odds Ratio (OR)|3.91||||0.0471|TWO_SIDED|95.0|1.02|15.01|||Regression, Logistic|Missing ASAS responses considered nonresponders||||15.01|1.02|0.0471
73925289|NCT01124604|147379072|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.46||||95.0|-1.04|0.8|||||Test for no difference between treatments was derived from Analysis of covariance (ANCOVA) model with factors treatment, disease and Baseline pain intensity as covariate.|||0.80|-1.04|
73925290|NCT01856790|147379089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.05
73925291|NCT01856790|147379090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.002
73925292|NCT01856790|147379092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.97
73925293|NCT01856790|147379096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon Matched Pairs signed rank tests|||||||.001
73925294|NCT01856790|147379097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.005
73925295|NCT04091646|147379099|SUPERIORITY||Odds Ratio (OR)|4.95|||<|0.0001|TWO_SIDED|95.0|2.51|9.76|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 8 Odds Ratio||9.76|2.51|<0.0001
73925296|NCT04091646|147379100|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0033|TWO_SIDED|95.0|1.46|7.52|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 2 Odds Ratio||7.52|1.46|0.0033
73925297|NCT04091646|147379100|SUPERIORITY||Odds Ratio (OR)|3.78||||0.0002|TWO_SIDED|95.0|1.94|7.38|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 4 Odds Ratio||7.38|1.94|0.0002
73925298|NCT04091646|147379101|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 2 Erythema Score||||<0.0001
73925299|NCT04091646|147379101|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 4 Erythema Score||||<0.0001
73925300|NCT04091646|147379101|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 8 Erythema Score||||<0.0001
73925301|NCT04091646|147379102|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0065|TWO_SIDED|95.0|1.49|17.13|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 2||17.13|1.49|0.0065
73968585|NCT02515773|147475477|SUPERIORITY||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|||||This is a calculated p-value less than 0.001|ANCOVA|||||||<0.001
73925302|NCT04091646|147379102|SUPERIORITY||Odds Ratio (OR)|5.36||||0.0002|TWO_SIDED|95.0|2.15|13.38|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 4||13.38|2.15|0.0002
73925303|NCT04091646|147379102|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0021|TWO_SIDED|95.0|1.5|6.63|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 8||6.63|1.50|0.0021
73925304|NCT04091646|147379103|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 2 Scaling Score||||<0.0001
73925305|NCT04091646|147379103|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 4 Scaling Score||||<0.0001
73925306|NCT04091646|147379103|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 8 Scaling Score||||<0.0001
73925307|NCT04091646|147379104|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0759|TWO_SIDED|95.0|0.9|4.33|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 2||4.33|0.90|0.0759
73925308|NCT04091646|147379104|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0122|TWO_SIDED|95.0|1.18|4.61|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 4||4.61|1.18|0.0122
73925309|NCT04091646|147379104|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0003|TWO_SIDED|95.0|1.74|6.55|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 8||6.55|1.74|0.0003
73968586|NCT02515773|147475478|SUPERIORITY||Mean Difference (Net)|0.09||||0.041|TWO_SIDED||||||ANCOVA|||||||0.041
73968587|NCT04749615|147475521|NON_INFERIORITY|Noninferiority Margin = (-Infinity, 1.28)||||||0.11|||||||t-test, 1 sided|||||||0.11
73968588|NCT04749615|147475522|NON_INFERIORITY|a noninferiority margin of 1.0 and 10% attrition|Mean Difference (Final Values)|0.05||||0.5|TWO_SIDED|95.0||||this is the calculated p-value.|t-test, 2 sided|||||||0.5
73968589|NCT05026320|147475550|EQUIVALENCE|The primary efficacy hypothesis to be tested was the equality of tenderness (algometry) over the initial 72 hours (algometry AUC 0-72).||||||0.0221|||||||ANCOVA|||||||0.0221
74028845|NCT03320512|147611751|SUPERIORITY||Average Treatment Effect|-0.91||||0.6|TWO_SIDED|95.0|-2.86|1.04||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.04|-2.86|0.60
73925310|NCT04091646|147379106|SUPERIORITY||Odds Ratio (OR)|3.62||||0.0007|TWO_SIDED|95.0|1.72|7.63|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 2||7.63|1.72|0.0007
73925311|NCT04091646|147379106|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0009|TWO_SIDED|95.0|1.63|6.68|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 4||6.68|1.63|0.0009
73925312|NCT04091646|147379106|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0007|TWO_SIDED|95.0|1.6|6.35|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 8||6.35|1.60|0.0007
73925313|NCT01762943|147379107|SUPERIORITY|||||||0.27|||||||repeated measures ANOVA|F=1.40, df=2,26||||||.27
73925314|NCT01762943|147379108|SUPERIORITY|||||||0.018|||||||repeated measures ANOVA|F=6.29, df=1,28||||||.018
73925315|NCT02120950|147379137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.7||||0.548|TWO_SIDED|95.0|-2.9|1.6|||ANCOVA|||||1.6|-2.9|0.5480
73925316|NCT02120950|147379138|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|0.6||||0.7402|TWO_SIDED|95.0|-3.1|4.3|||Cochran-Mantel-Haenszel|||||4.3|-3.1|0.7402
73925317|NCT02120950|147379140|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1||||0.0682|TWO_SIDED|95.0|0.0|0.2|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham - AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.|||0.2|0.0|0.0682
73925318|NCT02120950|147379141|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1||||0.164|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham - AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.|||0.3|-0.1|0.1640
73968590|NCT05478499|147475554|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.0001|TWO_SIDED|95.0|2.5|15.3|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Full Analysis Set||15.3|2.5|<0.0001
73968591|NCT05478499|147475554|SUPERIORITY||Odds Ratio (OR)|7.0|||<|0.0001|TWO_SIDED|95.0|2.7|18.4|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Patient sub-population (s-PGA ≥ 3)||18.4|2.7|<0.0001
73968592|NCT05478499|147475555|SUPERIORITY||Odds Ratio (OR)|40.2|||<|0.0001||95.0|4.6|352.0|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Full Analysis Set||352.0|4.6|<0.0001
73968593|NCT05478499|147475555|SUPERIORITY||Odds Ratio (OR)|37.3|||<|0.0001|TWO_SIDED|95.0|4.4|317.6|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Patient sub-population (s-PGA ≥ 3)||317.6|4.4|<0.0001
73968594|NCT05478499|147475556|SUPERIORITY||Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-3.3|-1.6|||analysis of covariance model||analysis of covariance model|Full Analysis Set||-1.6|-3.3|<0.0001
73968595|NCT05478499|147475556|SUPERIORITY||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.3|-1.5|||analysis of covariance model||analysis of covariance model|Patient sub-population (s-PGA ≥ 3)||-1.5|-3.3|<0.0001
73968596|NCT05478499|147475557|SUPERIORITY||Odds Ratio (OR)|23.9|||<|0.0001|TWO_SIDED|95.0|5.4|105.6|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|||105.6|5.4|<0.0001
73968597|NCT02962895|147475563|SUPERIORITY||Least Squares Mean Difference|0.75||||0.5161|TWO_SIDED|95.0|-1.52|3.02|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||3.02|-1.52|0.5161
73925319|NCT02120950|147379144|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-5.6||||0.2348|TWO_SIDED|95.0|-14.9|3.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 5||3.7|-14.9|0.2348
73925320|NCT02120950|147379144|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-2.2||||0.6877|TWO_SIDED|95.0|-13.1|8.6|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 10||8.6|-13.1|0.6877
73925321|NCT02120950|147379144|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-4.0||||0.4556|TWO_SIDED|95.0|-14.5|6.5|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 15||6.5|-14.5|0.4556
73925322|NCT02120950|147379145|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|1.7||||0.5372|TWO_SIDED|95.0|-3.7|7.2|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 5||7.2|-3.7|0.5372
73925323|NCT02120950|147379145|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|0.6||||0.7569|TWO_SIDED|95.0|-3.4|4.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 10||4.7|-3.4|0.7569
73925324|NCT02120950|147379145|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-0.6||||0.7402|TWO_SIDED|95.0|-4.3|3.1|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 15||3.1|-4.3|0.7402
73925325|NCT02120950|147379146|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-6.0||||0.3244|TWO_SIDED|95.0|-17.8|5.9|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|||5.9|-17.8|0.3244
73925326|NCT02120950|147379147|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1||||0.7109|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with leakage in FA at baseline and Week 52. Baseline values were not carried forward.||0.6|-0.9|0.7109
73925327|NCT02120950|147379148|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.1||||0.8355|TWO_SIDED|95.0|-9.2|11.3|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for CST at baseline and Week 52. Baseline values were not carried forward.||11.3|-9.2|0.8355
73968598|NCT02962895|147475563|SUPERIORITY||Least Squares Mean Difference|-0.55||||0.6332|TWO_SIDED|95.0|-2.8|1.71|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||1.71|-2.80|0.6332
73968599|NCT02962895|147475563|SUPERIORITY||Least Squares Mean Difference|-1.92||||0.0921|TWO_SIDED|95.0|-4.15|0.32|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||0.32|-4.15|0.0921
73968600|NCT02962895|147475565|SUPERIORITY||Least Squares Mean Difference|0.32||||0.4457|TWO_SIDED|95.0|-0.5|1.13|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||1.13|-0.50|0.4457
73968601|NCT02962895|147475565|SUPERIORITY||Least Square Mean Difference|0.01||||0.301|TWO_SIDED|95.0|-0.79|0.82|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||0.82|-0.79|0.301
73968602|NCT02962895|147475565|SUPERIORITY||Least Square Mean Difference|-0.06||||0.8858|TWO_SIDED|95.0|-0.86|0.74|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||0.74|-0.86|0.8858
73968603|NCT02962895|147475567|SUPERIORITY||Least Squares Mean Difference|-1.93||||0.3424|TWO_SIDED|95.0|-5.93|2.07|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||2.07|-5.93|0.3424
73968604|NCT02962895|147475567|SUPERIORITY||Least Squares Mean Difference|-2.56||||0.2092|TWO_SIDED|95.0|-6.58|1.45|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||1.45|-6.58|0.2092
73968605|NCT02962895|147475567|SUPERIORITY||Least Squares Mean Difference|0.31||||0.874|TWO_SIDED|95.0|-3.58|4.2|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||4.20|-3.58|0.8740
73968606|NCT02962895|147475569|SUPERIORITY||Least Squares Mean Difference|-1.02||||0.5768|TWO_SIDED|95.0|-4.61|2.57|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo / Mental Component Score||2.57|-4.61|0.5768
74087226|NCT01040793|147728358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.156|0.405|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.405|0.156|<0.0001
74087227|NCT01040793|147728358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.166|0.416|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.416|0.166|<0.0001
74087228|NCT01040793|147728359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.441|0.719|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.719|0.441|<0.0001
74087229|NCT01040793|147728359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.552|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001||95.0|0.412|0.691|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.691|0.412|<0.0001
74087230|NCT01352182|147728365|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
74087231|NCT01352182|147728366|SUPERIORITY|||||||1||||||threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||1.0
74087232|NCT01352182|147728367|SUPERIORITY|||||||0.154||||||threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.154
73925328|NCT02120950|147379149|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7||||0.5069|TWO_SIDED|95.0|-2.9|1.4|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for NEI VFQ-25 score at baseline and Week 52.||1.4|-2.9|0.5069
74028846|NCT03320512|147611752|SUPERIORITY||Average Treatment Effect|-0.06||||0.6|TWO_SIDED|95.0|-0.2|0.08||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.08|-0.20|0.60
74028847|NCT03320512|147611752|SUPERIORITY||Average Treatment Effect|-0.06||||0.6|TWO_SIDED|95.0|-0.21|0.09||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.09|-0.21|0.60
74028848|NCT03320512|147611752|SUPERIORITY||Average Treatment Effect|-0.13||||0.53|TWO_SIDED|95.0|-0.3|0.03||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.03|-0.30|0.53
74028849|NCT03320512|147611752|SUPERIORITY||Average Treatment Effect|-0.08||||0.6|TWO_SIDED|95.0|-0.24|0.08||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.08|-0.24|0.60
74028850|NCT03320512|147611752|SUPERIORITY||Average Treatment Effect|-0.11||||0.53|TWO_SIDED|95.0|-0.25|0.04||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.04|-0.25|0.53
74028851|NCT03320512|147611752|SUPERIORITY||Average Treatment Effect|-0.07||||0.6|TWO_SIDED|95.0|-0.2|0.07||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.07|-0.20|0.60
74028852|NCT03320512|147611753|SUPERIORITY||Average Treatment Effect|0.11|||||TWO_SIDED|95.0|-0.07|0.29|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.29|-0.07|
74028853|NCT03320512|147611753|SUPERIORITY||Average Treatment Effect|0.19|||||TWO_SIDED|95.0|0.03|0.34|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.34|0.03|
74087233|NCT01352182|147728368|SUPERIORITY|||||||0.683||||||significance threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.683
74087234|NCT01352182|147728369|SUPERIORITY|||||||0.08||||||significance threshold p\<0.05|t-test, 2 sided|||||||0.08
74087235|NCT01352182|147728370|OTHER|linear regression|Slope|-1.44|STANDARD_ERROR_OF_MEAN|0.3741||0.003|TWO_SIDED||||||Regression, Linear|||||||0.003
74087236|NCT02260258|147728414|EQUIVALENCE|Time variable log transformed and compared using linear regression controlling for shock stratification and site. Effect estimate represents geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.0||||0.82|TWO_SIDED|95.0|0.7|1.4||A priori threshold for significance 0.05|Regression, Linear|||||1.4|0.7|0.82
74087237|NCT02260258|147728415|EQUIVALENCE|LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out all patients (N = 37 in NMB and 43 in Usual Care)|Incidence rate ratio|1.4||||0.09|TWO_SIDED|95.0|1.0|1.9|||Negative binomial regression|||All patients analyzed (N = 37 in NMB and 43 in Usual Care)||1.9|1.0|0.09
74087238|NCT02260258|147728415|EQUIVALENCE|LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out on ICU survivors alone (n = 14 in NMB and 14 in Control)|Incidence rate ratio|1.3||||0.35|TWO_SIDED|95.0|0.8|2.0|||Negative binomial regression|||ICU survivors alone analyzed (n = 14 in each arm)||2.0|0.8|0.35
74087239|NCT02260258|147728416|EQUIVALENCE|Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes all patients (n=37 in NMB and n = 43 in control). Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.3||||0.18|TWO_SIDED|95.0|0.9|1.9|||Regression, Linear|Duration log transformed and so parameter estimate represents geometric mean difference.||Anaysis for the full data (n= 37 in NMB and 43 in Control)||1.9|0.9|0.18
73925329|NCT02120950|147379150|SUPERIORITY_OR_OTHER_LEGACY||Difference %|-0.6||||0.8423|TWO_SIDED|95.0|-6.3|5.1||The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12.|Cochran-Mantel-Haenszel||CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12.|||5.1|-6.3|0.8423
73925330|NCT02424383|147379151|OTHER||||||||||||||||||Freedom from Target LesionRevascularization (TLR) were reported through 12 months with frequency counts, percentages and 95% confidence intervals from exact binomial test. In addition, Kaplan-Meier tables and curves were created.|||
73925331|NCT02424383|147379152|OTHER||||||||||||||||||Freedom from composite of safety events from the time following the index procedure through 30 days post procedure were reported with frequency counts, percentages and 95% confidence intervals from exact binomial test. Kaplan-Meier tables and curves were also calculated.|||
73925332|NCT02438722|147379167|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.44|TWO_SIDED|95.0|0.5|1.36|||Log Rank|||||1.36|0.50|0.44
73925333|NCT02438722|147379168|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.72|1.43|||Log Rank|||||1.43|0.72|0.94
73925334|NCT02438722|147379170|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.54|TWO_SIDED|95.0|0.64|1.26|||Log Rank|||||1.26|0.64|0.54
73968607|NCT02962895|147475569|SUPERIORITY||Least Squares Mean Difference|0.68||||0.7113|TWO_SIDED|95.0|-2.93|4.28|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo / Mental Component Score||4.28|-2.93|0.7113
73968608|NCT02962895|147475569|SUPERIORITY||Least Squares Mean Difference|1.0||||0.5722|TWO_SIDED|95.0|-2.49|4.48|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo / Mental Component Score||4.48|-2.49|0.5722
73968609|NCT02962895|147475569|SUPERIORITY||Least Squares Mean Difference|1.84||||0.4138|TWO_SIDED|95.0|-1.59|3.83|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo / Physical Component Score||3.83|-1.59|0.4138
73968610|NCT02962895|147475569|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.4663|TWO_SIDED|95.0|-3.72|1.71|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo / Physical Component Score||1.71|-3.72|0.4663
73968611|NCT02962895|147475569|SUPERIORITY||Least Squares Mean Difference|1.84||||0.1694|TWO_SIDED|95.0|-0.79|4.47|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo / Physical Component Score||4.47|-0.79|0.1694
73968612|NCT02962895|147475571|SUPERIORITY||Least Squares Mean Difference|-4.17||||0.2671|TWO_SIDED|95.0|-11.56|3.22|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||3.22|-11.56|0.2671
73968613|NCT02962895|147475571|SUPERIORITY||Least Squares Mean Difference|-4.49||||0.2248|TWO_SIDED|95.0|-11.78|2.79|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||2.79|-11.78|0.2248
73968614|NCT02962895|147475571|SUPERIORITY||Least Squares Mean Difference|-8.36||||0.0224|TWO_SIDED|95.0|-15.51|-1.2|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||-1.20|-15.51|0.0224
73925335|NCT02438722|147379171|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.73|1.39|||Log Rank|||||1.39|0.73|0.95
73925336|NCT00909779|147379179|NON_INFERIORITY_OR_EQUIVALENCE|"The study was powered under a one-sided alternative hypothesis, in which arformoterol is superior to placebo, with a hazard ratio of 0.80 or less. To achieve 80% power, it was necessary to observe 86 total events for the primary endpoint adjusted for interim analysis. Assuming an annual event proportion of 17.3% in the placebo group and 30% lost to follow-up, we anticipated to randomize approximately 900 subjects (450 per arm).~The non-inferiority margin for the hazard ratio is 1.4."|Hazard Ratio (HR)|0.606|||||TWO_SIDED|95.0|0.425|0.864|||Regression, Cox||Hazard ratio was calculated as arformoterol vs. placebo.|"The null hypothesis is: There is 40% or higher excess risk of the primary events in the arformoterol group relative to placebo (a constant hazard ratio of 1.4).~The primary analysis was a Cox proportional hazards regression model, with treatment group, baseline smoking status, sex, age, BMI, and baseline FEV1 as covariates. The hazard ratio and 90% two-sided confidence interval for the hazard ratio (adjusted for the interim analysis) comparing arformoterol to placebo were estimated."||0.864|0.425|
73925337|NCT00117559|147379188|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<.05
73925338|NCT02738333|147379193|NON_INFERIORITY|A sample size of 100 participants per treatment group would provide over 90% power to establish non-inferiority in the SVR12 rates between the LDV/SOF group and SOF+RBV group. Sample size was based on the assumptions that the clinically meaningful non-inferiority margin is 10%, both groups have a SVR12 rate of 96%, and the significance level is 0.025 one-sided.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.3|7.1|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||7.1|-5.3|
73968615|NCT02962895|147475573|SUPERIORITY||Least Squares Mean Difference|2.27||||0.6457|TWO_SIDED|95.0|-7.46|12.0|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||12.00|-7.46|0.6457
73968616|NCT02962895|147475573|SUPERIORITY||Least Squares Mean Difference|3.26||||0.5132|TWO_SIDED|95.0|-6.55|13.06|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||13.06|-6.55|0.5132
73968617|NCT02962895|147475573|SUPERIORITY||Least Squares Mean Difference|-4.77||||95|TWO_SIDED|95.0|-14.21|4.68|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||4.68|-14.21|95
73968618|NCT02962895|147475574|SUPERIORITY||Least Squares Mean Difference|0.11||||0.271|TWO_SIDED|95.0|-0.08|0.3|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo (Stimulated salivary flow rate)||0.30|-0.08|0.2710
73968619|NCT02962895|147475574|SUPERIORITY||Least Squares Mean Difference|0.13||||0.1618|TWO_SIDED|95.0|-0.05|0.32|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo (Stimulated salivary flow rate)||0.32|-0.05|0.1618
73925339|NCT00579826|147379232|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
73925340|NCT00579826|147379233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
73925341|NCT00579826|147379234|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
73925342|NCT00579826|147379235|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
73925343|NCT00579826|147379236|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
73925344|NCT04191382|147379237|OTHER|Other descriptive analysis|Ratio of Geometric Means|1.08|||||TWO_SIDED|95.0|0.72|1.63||||||Geometric LS-means ratio of proportional change was the ratio of geometric LS-means of the proportional change between groups (Amcenestrant 400 mg versus Letrozole 2.5 mg).||1.63|0.72|
73925345|NCT04191382|147379237|OTHER|Other descriptive analysis|Ratio of Geometric Means|1.42|||||TWO_SIDED|95.0|0.95|2.12||||||Geometric LS-means ratio of proportional change was the ratio of geometric LS-means of the proportional change between groups (Amcenestrant 200 mg versus Letrozole 2.5 mg).||2.12|0.95|
73925346|NCT01748643|147379244|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
73925347|NCT01748643|147379245|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
73925348|NCT01748643|147379246|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
73925349|NCT01748643|147379247|SUPERIORITY|||||||0.97|||||||t-test, 1 sided|||||||0.97
73925350|NCT01748643|147379248|SUPERIORITY|||||||0.64|||||||t-test, 1 sided|||||||0.64
73925351|NCT01748643|147379249|SUPERIORITY|||||||0.58|||||||t-test, 1 sided|||||||0.58
73968620|NCT02962895|147475574|SUPERIORITY||Least Squares Mean Difference|0.2||||0.0374|TWO_SIDED|95.0|0.01|0.38|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo (Stimulated salivary flow rate)||0.38|0.01|0.0374
73968621|NCT02962895|147475574|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9559|TWO_SIDED|95.0|-0.09|0.09|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo (Unstimulated salivary flow rate)||0.09|-0.09|0.9559
74028854|NCT03320512|147611753|SUPERIORITY||Average Treatment Effect|-0.06|||||TWO_SIDED|95.0|-0.27|0.15|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.15|-0.27|
73925352|NCT02009046|147379318|SUPERIORITY||Odds Ratio (OR)|1.09||||0.643|TWO_SIDED|95.0|0.75|1.6|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.60|0.75|0.6430
73925353|NCT02009046|147379318|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3718|TWO_SIDED|95.0|0.39|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.44|0.39|0.3718
73925354|NCT02009046|147379319|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8083|TWO_SIDED|95.0|0.67|1.37|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.37|0.67|0.8083
73925355|NCT02009046|147379319|SUPERIORITY||Odds Ratio (OR)|0.6||||0.1083|TWO_SIDED|95.0|0.32|1.13|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.13|0.32|0.1083
73925356|NCT02009046|147379320|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1006|TWO_SIDED|95.0|0.35|1.1|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.10|0.35|0.1006
73925357|NCT02009046|147379320|SUPERIORITY||Odds Ratio (OR)|0.49||||0.2117|TWO_SIDED|95.0|0.16|1.53|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.53|0.16|0.2117
73925358|NCT02009046|147379321|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0218|TWO_SIDED|95.0|1.05|1.78|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.78|1.05|0.0218
73925359|NCT02009046|147379321|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0211|TWO_SIDED|95.0|1.09|2.75|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.75|1.09|0.0211
73925360|NCT02009046|147379322|SUPERIORITY||Odds Ratio (OR)|1.25||||0.1763|TWO_SIDED|95.0|0.9|1.73|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.73|0.90|0.1763
73925361|NCT02009046|147379322|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5869|TWO_SIDED|95.0|0.45|1.58|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.58|0.45|0.5869
73925362|NCT02009046|147379323|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8102|TWO_SIDED|95.0|0.75|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.44|0.75|0.8102
73925363|NCT02009046|147379323|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2956|TWO_SIDED|95.0|0.39|1.34|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.34|0.39|0.2956
73925364|NCT02009046|147379324|SUPERIORITY||Odds Ratio (OR)|1.13||||0.4645|TWO_SIDED|95.0|0.82|1.56|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.56|0.82|0.4645
73925365|NCT02009046|147379324|SUPERIORITY||Odds Ratio (OR)|0.77||||0.3809|TWO_SIDED|95.0|0.43|1.4|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.40|0.43|0.3809
73925366|NCT02009046|147379325|SUPERIORITY||Odds Ratio (OR)|0.75||||0.1335|TWO_SIDED|95.0|0.52|1.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.09|0.52|0.1335
73925367|NCT02009046|147379325|SUPERIORITY||Odds Ratio (OR)|0.56||||0.0741|TWO_SIDED|95.0|0.29|1.06|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.06|0.29|0.0741
73925368|NCT02009046|147379326|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9085|TWO_SIDED|95.0|0.54|2.01|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.01|0.54|0.9085
73968622|NCT02962895|147475574|SUPERIORITY||Least Squares Mean Difference|0.0||||0.929|TWO_SIDED|95.0|-0.09|0.08|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo (Unstimulated salivary flow rate)||0.08|-0.09|0.9290
73968623|NCT02962895|147475574|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.7276|TWO_SIDED|95.0|-0.1|0.07|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo (Unstimulated salivary flow rate)||0.07|-0.10|0.7276
73862292|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||||90.0|-3.8|1.59|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.59|-3.80|
73925369|NCT02009046|147379326|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8059|TWO_SIDED|95.0|0.36|3.62|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||3.62|0.36|0.8059
73925370|NCT02009046|147379327|SUPERIORITY||Odds Ratio (OR)|0.87||||0.6861|TWO_SIDED|95.0|0.44|1.71|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.71|0.44|0.6861
73925371|NCT02009046|147379327|SUPERIORITY||Odds Ratio (OR)|0.0||||0.9973|TWO_SIDED||||||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|No results provided, as model would not converge.|||||0.9973
73925372|NCT02009046|147379328|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0002|TWO_SIDED|95.0|1.39|2.8|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.80|1.39|0.0002
73968624|NCT05894577|147475580|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.92|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.92|
73968625|NCT05894577|147475581|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.14|7.07|||||Low event rate precluded covariate adjustment.|No hypothesis test or decision rule was evaluated.||7.07|0.14|
73968626|NCT05894577|147475584|SUPERIORITY|Posterior probability of efficacy (P(HR\<1))|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.45|1.84|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.84|0.45|
73968627|NCT05894577|147475585|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.5|2.29|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||2.29|0.50|
73968628|NCT05894577|147475586|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.16|1.49|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.49|0.16|
73968629|NCT05894577|147475587|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.33|2.96|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||2.96|0.33|
73968630|NCT05894577|147475588|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.71|1.31|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.31|0.71|
73968631|NCT05894577|147475588|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.75|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.51|0.75|
73968632|NCT05894577|147475588|OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.84|1.88|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.88|0.84|
73968633|NCT05894577|147475588|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.65|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.60|0.65|
74028855|NCT03320512|147611753|SUPERIORITY||Average Treatment Effect|-0.02|||||TWO_SIDED|95.0|-0.21|0.16|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.16|-0.21|
74028856|NCT03320512|147611754|SUPERIORITY||Average Treatment Effect|0.11|||||TWO_SIDED|95.0|-0.05|0.26|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.26|-0.05|
74028857|NCT03320512|147611754|SUPERIORITY||Average Treatment Effect|0.13|||||TWO_SIDED|95.0|-0.04|0.29|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.29|-0.04|
73925373|NCT02009046|147379328|SUPERIORITY||Odds Ratio (OR)|2.71||||0.003|TWO_SIDED|95.0|1.44|5.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||5.09|1.44|0.0030
73925374|NCT00620828|147379329|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Patient cohort was inclusive of patient undergoing single TKA from June 2007 to July 2008. Effect size was calculated for the numeric pain rating scale at the immediate post-operative period, 4-hour, 8-hour , 12-hour, and 24-hour time periods as a means to assess post-operative pain control.||||<0.05
73925375|NCT00620828|147379330|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||Significant differences in Fentanyl PCA pump usage across study arms were assessed for the 4-8h,8-12h,and 12h-24h time frames.||||.05
73925376|NCT00620828|147379331|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||This analysis was performed on data collected 24-hours post-operatively for patient cohort.||||.05
73925377|NCT00620828|147379332|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort.||||.05
73925378|NCT00620828|147379333|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||Straight leg raise data collected at 4-hours, 8-hours, 12-hours and 24-hours post-operatively for patient cohort.||||.05
73925379|NCT00335972|147379338|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For MAP with a noninferiority delta of 7.5 mmHg and expected the SD of 12, we needed a maximum of N= 65 per group. Incorporating the two interim and one final analyses, we thus planned a maximum sample size of N=71/group (N=142 total).|Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|95.0|-13.0|-5.0||Noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest). Bonferroni correction was used for superiority testing and 97.5% CI were reported.|repeated measures ANOVA||mean difference: Dexmedetomidine arm - Remifentanil arm|||-5|-13|<0.001
73925380|NCT00335972|147379338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|97.5|-13.0|-4.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test||-4|-13|<0.001
73925381|NCT00335972|147379339|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For VRS pain, the standard deviation (SD) was expected to be about 1.75, such that with a noninferiority delta of 1, we needed a maximum of N= 66 per group|Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest).|repeated measures ANOVA model||mean difference: Dexmedetomidine arm - Remifentanil arm|||-1.1|-2.7|<0.001
73925382|NCT00335972|147379339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|97.5|-2.8|-0.9||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test||-0.9|-2.8|<0.001
73925383|NCT00335972|147379340|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority.we needed a maximum of N= 65 per group. We assumed for opioids that the coefficient of variation (SD/mean) was about 0.4, resulting in a similar sample size (64/group) with noninferiority deltas of 20% of the observed mean|Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest)|Wilcoxon (Mann-Whitney)||mean difference: Dexmedetomidine arm - Remifentanil|||-5|-10|<0.001
73925384|NCT00335972|147379340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|97.5|-10.0|-3.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI)|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority||-3|-10|<0.001
73862293|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||||90.0|-3.55|-0.31|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.31|-3.55|
73925385|NCT03090100|147379419|NON_INFERIORITY|Non-inferiority margin of 10%|Difference in percentage|14.2|||<|0.001|TWO_SIDED|95.0|9.2|19.2|||z-test|||||19.2|9.2|<0.001
73925386|NCT03090100|147379419|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73925387|NCT03090100|147379420|NON_INFERIORITY|Non-inferiority margin of 10%|Difference in percentage|4.3|||<|0.001|TWO_SIDED|95.0|-0.2|8.9|||z-test|||||8.9|-0.2|<0.001
73925388|NCT03090100|147379420|SUPERIORITY|||||||0.062|||||||Cochran-Mantel-Haenszel|||||||0.062
73925389|NCT03090100|147379421|OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-12.2|-1.7||||||||-1.7|-12.2|
73925390|NCT03090100|147379422|OTHER||Difference in percentage|-2.3|||||TWO_SIDED|95.0|-6.0|1.2||||||||1.2|-6.0|
73925391|NCT03090100|147379423|OTHER||Difference in percentage|9.7|||||TWO_SIDED|95.0|3.8|15.5||||||||15.5|3.8|
73925392|NCT03090100|147379424|OTHER||Difference in percentage|11.6|||||TWO_SIDED|95.0|5.8|17.4||||||||17.4|5.8|
73925393|NCT03090100|147379425|OTHER||Difference in percentage|9.7|||||TWO_SIDED|95.0|4.9|14.5||||||||14.5|4.9|
73925394|NCT03090100|147379426|OTHER||Difference in percentage|7.8|||||TWO_SIDED|95.0|2.3|13.2||||||||13.2|2.3|
73925395|NCT03090100|147379427|OTHER||Difference in percentage|-0.3|||||TWO_SIDED|95.0|-3.5|3.1||||||||3.1|-3.5|
73925396|NCT03090100|147379428|OTHER||Difference in percentage|-1.4|||||TWO_SIDED|95.0|-6.2|3.4||||||||3.4|-6.2|
73925397|NCT03090100|147379429|OTHER||Difference in percentage|9.8|||||TWO_SIDED|95.0|4.2|15.3||||||||15.3|4.2|
73925398|NCT03090100|147379430|OTHER||Difference in percentage|-0.1|||||TWO_SIDED|95.0|-4.2|3.9||||||||3.9|-4.2|
73925399|NCT03090100|147379431|OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-5.0|3.3||||||||3.3|-5.0|
73925400|NCT00159588|147379437|SUPERIORITY|||||||0.056||||||Between-group analysis|Kruskal-Wallis|||Kruskal-Wallis test||||0.056
73925401|NCT00159588|147379438|SUPERIORITY|Between-group analysis||||||0.012||||||Between-group analysis|t-test, 2 sided|Kruskal-Wallis test||Kruskal-Wallis test||||0.012
73925402|NCT04920123|147379446|SUPERIORITY|||||||0.997||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.997
73925403|NCT04920123|147379447|SUPERIORITY|||||||0.5||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.500
73925404|NCT04920123|147379448|SUPERIORITY|||||||0.821||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.821
73925405|NCT04920123|147379449|SUPERIORITY|||||||0.995||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.995
73925406|NCT04920123|147379450|NON_INFERIORITY|Higher scores indicate more severe depression.||||||0.076|||||||t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.076
73925407|NCT04920123|147379451|SUPERIORITY|||||||0.432|||||||t-test, 1 sided|The threshold for statistical significance was p=0.05||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.432
73925408|NCT04920123|147379452|SUPERIORITY|Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||||0.75|||||||t-test, 1 sided|||||||0.750
73925409|NCT05352815|147379459|SUPERIORITY|Change in HbA1c from baseline to week 52 is analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors and baseline HbA1c as covariate. Missing HbA1c values at week 52 are imputed by using multiple imputation. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.|Treatment difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.57|||ANCOVA|||||-0.57|-0.76|<0.0001
73925410|NCT02759120|147379469|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.83|TWO_SIDED|95.0|0.71|1.53|||Regression, Cox|||||1.53|0.71|0.83
73925411|NCT02759120|147379470|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.65|TWO_SIDED|95.0|0.7|1.78|||Regression, Cox|||||1.78|0.70|0.65
73925412|NCT02759120|147379471|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.25|TWO_SIDED|95.0|0.82|2.17|||Regression, Cox|||||2.17|0.82|0.25
73925413|NCT02759120|147379472|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.13|TWO_SIDED|95.0|0.91|2.01|||Regression, Cox|||||2.01|0.91|0.13
73925414|NCT02759120|147379473|SUPERIORITY||Risk Ratio (RR)|1.21||||0.4|TWO_SIDED|95.0|0.78|1.89|||Regression, Cox|||||1.89|0.78|0.40
73925415|NCT02759120|147379474|SUPERIORITY||Risk Ratio (RR)|1.29||||0.16|TWO_SIDED|95.0|0.9|1.83|||Regression, Cox|||||1.83|0.90|0.16
73925416|NCT02759120|147379475|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.19|TWO_SIDED|95.0|-0.56|2.83|||Regression, Cox|||||2.83|-0.56|0.19
73925417|NCT02759120|147379476|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.51|TWO_SIDED|95.0|-1.67|3.35|||Regression, Cox|||||3.35|-1.67|0.51
73925418|NCT02759120|147379477|SUPERIORITY||Risk Ratio (RR)|0.71||||0.13|TWO_SIDED|95.0|0.46|1.11|||Regression, Cox|||||1.11|0.46|0.13
73925419|NCT02759120|147379478|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.76|TWO_SIDED|95.0|-4.64|3.39|||Regression, Cox|||||3.39|-4.64|0.76
74028858|NCT03320512|147611754|SUPERIORITY||Average Treatment Effect|0.09|||||TWO_SIDED|95.0|-0.08|0.26|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.26|-0.08|
73925420|NCT02759120|147379479|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.54|TWO_SIDED|95.0|-0.24|0.46|||Regression, Cox|||||0.46|-0.24|0.54
73925421|NCT02759120|147379480|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.99|TWO_SIDED|95.0|-0.79|0.8|||Regression, Linear|||||0.80|-0.79|0.99
73925422|NCT02759120|147379481|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.76|TWO_SIDED|95.0|-4.64|3.39|||Regression, Cox|||||3.39|-4.64|0.76
73925423|NCT02759120|147379482|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.63|TWO_SIDED|95.0|-0.031|0.051|||Regression, Cox|||||0.051|-0.031|0.63
73925424|NCT02759120|147379483|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.15|TWO_SIDED|95.0|-0.007|0.043|||Regression, Cox|||||0.043|-0.007|0.15
73925425|NCT02759120|147379484|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.53|TWO_SIDED|95.0|-1.11|2.15|||Regression, Cox|||||2.15|-1.11|0.53
73925426|NCT02759120|147379485|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.75|TWO_SIDED|95.0|-1.61|2.2|||Regression, Linear|||||2.20|-1.61|0.75
73925427|NCT00278954|147379505|SUPERIORITY_OR_OTHER||SABI per subject per year|0.0||||0.01||99.0|0.0|0.101|||Poisson regression with log link||Mean SABI rate = 0 per subject per year. 1-sided 99% upper confidence bound could not be calculated.|The estimated serious acute bacterial infection (SABI) rate was calculated by dividing no. of infections by no.of subject years. The exponential of the upper limit of the 98% 2-sided Confidence Interval (CI) gave the upper, 1-sided, 99% confidence bound, estimated using Poisson regression. The equivalent upper bound per subject year was obtained by dividing this figure by total subject years.||0.101|0|0.01
73925428|NCT04452331|147379572|SUPERIORITY|||||||0.06|||||||Regression, Linear|Adjusted for clinical site||Diastolic BP||||0.06
73925429|NCT04452331|147379572|SUPERIORITY|||||||0.9|||||||Regression, Linear|||Systolic BP||||0.90
73925430|NCT04452331|147379574|SUPERIORITY|||||||0.29|||||||Regression, Linear|||||||.29
73925431|NCT04452331|147379575|SUPERIORITY|||||||0.1|||||||Regression, Logistic|||||||.10
73925432|NCT04452331|147379576|SUPERIORITY|||||||0.44|||||||Regression, Linear|||||||0.44
73925433|NCT04452331|147379577|SUPERIORITY|||||||0.01|||||||Regression, Linear|||||||0.01
73925434|NCT04452331|147379578|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||||||0.01
73925435|NCT04452331|147379579|SUPERIORITY|||||||0.54|||||||Regression, negative binomial|||||||0.54
73925436|NCT04452331|147379580|SUPERIORITY|||||||0.74|||||||Regression, negative binomial|||||||0.74
73925437|NCT04452331|147379581|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
73925438|NCT04452331|147379581|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
73925439|NCT04452331|147379582|SUPERIORITY||||||<|0.001|||||||Regression, negative binomial|||||||<0.001
73925440|NCT04452331|147379582|SUPERIORITY|||||||0.03|||||||Regression, negative binomial|||||||0.03
73925441|NCT04452331|147379583|SUPERIORITY||||||<|0.001|||||||Regression, poisson|||||||<0.001
73925442|NCT04452331|147379583|SUPERIORITY|||||||0.08|||||||Regression, poisson|||||||0.08
73925443|NCT04452331|147379584|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Mixed effects logistic regression including random effect of visit, to incorporate clustering of prescriptions within visits.||||||<.001
73925444|NCT04452331|147379584|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|Mixed effects logistic regression including random effect of visit, to incorporate clustering of prescriptions within visits.||||||0.98
73925445|NCT04452331|147379585|SUPERIORITY|||||||0.2|||||||Regression, Linear|||Systolic BP||||0.20
73925446|NCT04452331|147379585|SUPERIORITY|||||||0.82|||||||Regression, Linear|||Systolic BP||||0.82
73925447|NCT04452331|147379585|SUPERIORITY|||||||0.12|||||||Regression, Linear|||Diastolic BP||||0.12
73925448|NCT04452331|147379585|SUPERIORITY|||||||0.1|||||||Regression, Linear|||Diastolic BP||||0.10
73925449|NCT01232920|147379600|SUPERIORITY_OR_OTHER|||||||0.09|||||||Fisher Exact|||||||0.09
73925450|NCT02211131|147379612|OTHER||Hazard Ratio (HR)|0.75||||0.07|TWO_SIDED|80.0|0.58|0.96||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.96|0.58|0.070
74028859|NCT03320512|147611754|SUPERIORITY||Average Treatment Effect|0.03|||||TWO_SIDED|95.0|-0.13|0.19|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.19|-0.13|
73925451|NCT02211131|147379613|OTHER||Hazard Ratio (HR)|0.76||||0.092|TWO_SIDED|80.0|0.6|0.97||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.97|0.60|0.092
74028860|NCT03320512|147611755|SUPERIORITY||Average Treatment Effect|0.09||||0.11|TWO_SIDED|95.0|-0.02|0.19|||TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.19|-0.02|0.11
74028861|NCT03320512|147611755|SUPERIORITY||Average Treatment Effect|-0.01||||0.82|TWO_SIDED|95.0|-0.14|0.11|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.11|-0.14|0.82
73925452|NCT02211131|147379615|OTHER||Treatment Difference|4.3||||0.594|TWO_SIDED|80.0|-6.9|15.3||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||An 80% approximate exact CI for between-arm differences in binary rate is calculated using Wilson's score method with continuity correction.|||15.3|-6.9|0.594
73925453|NCT02211131|147379616|OTHER||Treatment Difference|14.4||||0.003|TWO_SIDED|80.0|7.4|21.6||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||80% exact CI for binary rate of each arm is calculated using the Clopper Pearson method.|||21.6|7.4|0.003
73925454|NCT02211131|147379621|OTHER||Hazard Ratio (HR)|0.54||||0.05|TWO_SIDED|80.0|0.36|0.81||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.81|0.36|0.050
73925455|NCT00755131|147379647|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Sample size determination was based on a t-test assuming a normal distribution with non-equal variance with the mean and standard deviation for the experimental group (postinfarction patients) of HMGB1 levels equal to 15 ± 7 and 2 ± 1 ng/dl for the control group derived from a previous study, respectively. The required sample size was calculated to be 30 subjects per group to detect on the size of one SD with α value of 0.05 (two-sided) and power (1 - β) of 0.8.||||<0.05
73925456|NCT00755131|147379648|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73925457|NCT00755131|147379649|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73925458|NCT03167879|147379671|SUPERIORITY||Odds Ratio (OR)|10.63|||||TWO_SIDED|95.0|2.79|40.49||||||||40.49|2.79|
73925459|NCT03167879|147379672|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.25|2.09||||||||2.09|0.25|
73925460|NCT03167879|147379673|SUPERIORITY||Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.02|257.6||||||||257.6|0.02|
73925461|NCT01480076|147379684|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 3: Mixed effect model for repeated measures with visit, baseline PCS score, baseline Expanded Disability Status Scale (EDSS) score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925462|NCT01480076|147379684|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925463|NCT01480076|147379684|SUPERIORITY_OR_OTHER||least squares mean|0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0007|TWO_SIDED||||||mixed effect model|||Difference of Month 3 versus Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
73925464|NCT01480076|147379684|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within-group p-value|mixed effect model|||Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925465|NCT01480076|147379684|SUPERIORITY_OR_OTHER||least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2531|TWO_SIDED||||||mixed effect model|||Difference of Month 6 versus Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2531
74028862|NCT03320512|147611756|SUPERIORITY||Average Treatment Effect|8.95||||0.05|TWO_SIDED|95.0|0.07|17.83||The a priori threshold for statistical significance is 0.025.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||17.83|0.07|0.05
74028863|NCT03320512|147611756|SUPERIORITY||Average Treatment Effect|-3.69||||0.45|TWO_SIDED|95.0|-13.33|5.95|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||5.95|-13.33|0.45
73925466|NCT01480076|147379684|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925467|NCT01480076|147379684|SUPERIORITY_OR_OTHER||least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2299|TWO_SIDED||||||mixed effect model|||Difference of Month 9 versus Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2299
73925468|NCT01480076|147379685|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925469|NCT01480076|147379685|SUPERIORITY_OR_OTHER|||||||0.5405|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5405
73925470|NCT01480076|147379685|SUPERIORITY_OR_OTHER||least squares mean|3.7|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925471|NCT01480076|147379685|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925472|NCT01480076|147379685|SUPERIORITY_OR_OTHER|||||||0.7272|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7272
73925473|NCT01480076|147379685|SUPERIORITY_OR_OTHER||least squares mean|4.3|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925474|NCT01480076|147379685|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925475|NCT01480076|147379685|SUPERIORITY_OR_OTHER|||||||0.7484|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7484
73925476|NCT01480076|147379685|SUPERIORITY_OR_OTHER||least squares mean|3.0|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925477|NCT01480076|147379685|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925478|NCT01480076|147379685|SUPERIORITY_OR_OTHER|||||||0.1877|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1877
73925479|NCT01480076|147379685|SUPERIORITY_OR_OTHER||least squares mean|4.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925480|NCT01480076|147379685|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968634|NCT05894577|147475588|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.57|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.36|0.57|
73925481|NCT01480076|147379685|SUPERIORITY_OR_OTHER|||||||0.546|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5460
73925482|NCT01480076|147379685|SUPERIORITY_OR_OTHER||least squares mean|3.3|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925483|NCT01480076|147379686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925484|NCT01480076|147379686|SUPERIORITY_OR_OTHER|||||||0.9073|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9073
73925485|NCT01480076|147379686|SUPERIORITY_OR_OTHER||least squares mean|3.0|STANDARD_ERROR_OF_MEAN|0.89||0.0009|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0009
73925486|NCT01480076|147379686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925487|NCT01480076|147379686|SUPERIORITY_OR_OTHER|||||||0.5542|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5542
73925488|NCT01480076|147379686|SUPERIORITY_OR_OTHER||least squares mean|4.8|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925489|NCT01480076|147379686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925490|NCT01480076|147379686|SUPERIORITY_OR_OTHER|||||||0.581|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5810
73925491|NCT01480076|147379686|SUPERIORITY_OR_OTHER||least squares mean|2.7|STANDARD_ERROR_OF_MEAN|1.08||0.014|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0140
73925492|NCT01480076|147379686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925493|NCT01480076|147379686|SUPERIORITY_OR_OTHER|||||||0.4138|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4138
73968635|NCT05894577|147475588|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.69|2.0|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||2.00|0.69|
73968636|NCT05894577|147475589|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.66|1.15|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.15|0.66|
73968637|NCT05894577|147475589|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.63|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.14|0.63|
73925494|NCT01480076|147379686|SUPERIORITY_OR_OTHER||least squares mean|1.3|STANDARD_ERROR_OF_MEAN|1.19||0.274|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2740
73925495|NCT01480076|147379686|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925496|NCT01480076|147379686|SUPERIORITY_OR_OTHER|||||||0.6453|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6453
73968638|NCT05894577|147475589|OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.56|1.08|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.08|0.56|
73968639|NCT05894577|147475589|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.73|1.45|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.45|0.73|
73968640|NCT05894577|147475589|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.71|1.4|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.40|0.71|
73968641|NCT05894577|147475589|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.6|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.60|
73968642|NCT05894577|147475590|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.7|1.31|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.31|0.70|
74028864|NCT03320512|147611757|SUPERIORITY||Incremental cost effectiveness ratio|25.79|||||TWO_SIDED|95.0|-194.05|236.81|||||The confidence interval was created using percentile bootstrap.|Participants were included if they were at an active site with cost data and had a 3-month binary TFV measure.||236.81|-194.05|
74028865|NCT00638846|147611758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.739|||||TWO_SIDED|97.4|1.136|1.739|||Generalized Linear Model||Odds ratio was senofilcon A toric / balafilcon A toric|Alternative hypothesis is senofilcon A toric is superior to balfilcon A toric by having less degrees of rotation||1.739|1.136|
74028866|NCT00638846|147611759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.138|||||TWO_SIDED|97.4|0.624|1.138|||Generalized Linear Model||Odds ratio was senofilcon A toric/balafilcon A toric|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less degrees of instability.||1.138|0.624|
74028867|NCT00638846|147611760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1307|STANDARD_ERROR_OF_MEAN|0.2856|||TWO_SIDED|97.5|-1.1307|-0.568|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon At toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less time required to fit.||-0.5680|-1.1307|
73925497|NCT01480076|147379686|SUPERIORITY_OR_OTHER||least squares mean|3.1|STANDARD_ERROR_OF_MEAN|1.18||0.009|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0090
73925498|NCT01480076|147379687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968643|NCT05894577|147475590|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.72|1.4|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.40|0.72|
73968644|NCT05894577|147475590|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.55|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.20|0.55|
73968645|NCT05894577|147475590|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.62|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.39|0.62|
73968646|NCT05894577|147475590|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.65|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.46|0.65|
73968647|NCT05894577|147475590|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.48|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.48|
73862294|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.99||||||90.0|-7.69|-2.3|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.30|-7.69|
73862295|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||||90.0|-4.58|-1.34|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.34|-4.58|
73968648|NCT05894577|147475591|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.62|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.24|0.62|
73968649|NCT05894577|147475591|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.65|1.38|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.38|0.65|
73968650|NCT05894577|147475591|OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.49|1.13|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.13|0.49|
73968651|NCT05894577|147475591|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.67|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.55|0.67|
73968652|NCT05894577|147475591|OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.51|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.19|0.51|
73968653|NCT05894577|147475591|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.49|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.49|
73968654|NCT05894577|147475592|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.41|0.77|
73968655|NCT05894577|147475592|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.82|1.69|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.69|0.82|
73968656|NCT05894577|147475592|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.52|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.52|
73968657|NCT05894577|147475592|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.65|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.43|0.65|
73968658|NCT05894577|147475592|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.63|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.41|0.63|
73968659|NCT05894577|147475592|OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.44|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.19|0.44|
73968660|NCT05894577|147475593|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.75|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.39|0.75|
73968661|NCT05894577|147475593|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.76|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.44|0.76|
73968662|NCT05894577|147475593|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.84|1.71|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.71|0.84|
73968663|NCT05894577|147475593|OTHER||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.76|1.71|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.71|0.76|
73925499|NCT01480076|147379687|SUPERIORITY_OR_OTHER|||||||0.2475|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2475
73925500|NCT01480076|147379687|SUPERIORITY_OR_OTHER||least squares mean|-8.2|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968664|NCT05894577|147475593|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.67|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.46|0.67|
73925501|NCT01480076|147379687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925502|NCT01480076|147379687|SUPERIORITY_OR_OTHER|||||||0.2422|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2422
73925503|NCT01480076|147379687|SUPERIORITY_OR_OTHER||least squares mean|-10.9|STANDARD_ERROR_OF_MEAN|1.72|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925504|NCT01480076|147379687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925505|NCT01480076|147379687|SUPERIORITY_OR_OTHER|||||||0.1262|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1262
73968665|NCT05894577|147475593|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.62|1.59|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.59|0.62|
73968666|NCT05894577|147475594|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.74|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.14|0.74|
73968667|NCT05894577|147475594|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.79|1.22|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.22|0.79|
73968668|NCT05894577|147475594|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.71|1.08|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.08|0.71|
74028868|NCT00638846|147611761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.368|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|97.4|0.07001|0.368|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A is superior to balafilcon A.||0.3680|0.07001|
73925506|NCT01480076|147379687|SUPERIORITY_OR_OTHER||least squares mean|-7.6|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968669|NCT05894577|147475594|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.21|0.80|
73968670|NCT05894577|147475594|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.29|0.84|
73968671|NCT05894577|147475594|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.68|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.14|0.68|
73925507|NCT01480076|147379687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925508|NCT01480076|147379687|SUPERIORITY_OR_OTHER|||||||0.8858|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8858
73925509|NCT01480076|147379687|SUPERIORITY_OR_OTHER||least squares mean|-8.6|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925510|NCT01480076|147379687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925511|NCT01480076|147379687|SUPERIORITY_OR_OTHER|||||||0.2111|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2111
73925512|NCT01480076|147379687|SUPERIORITY_OR_OTHER||least squares mean|-5.8|STANDARD_ERROR_OF_MEAN|2.16||0.0072|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0072
73968672|NCT05894577|147475595|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|-0.24|||||TWO_SIDED|95.0|-0.6|0.1|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.1|-0.6|
73968673|NCT05894577|147475596|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimated means|0.31|||||TWO_SIDED|95.0|-0.13|0.75|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.75|-0.13|
73968674|NCT03476460|147475638|NON_INFERIORITY|"We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable.~The non-inferiority of oral hydration would be shown if the upper limit of the 95% CI of the absolute risk difference between the groups was less than 5% (non-inferiority margin, indicated by the black dashed line)"|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.8|7.0|||||The 95% confidence interval for the difference between the two independent proportions was calculated according to Wilson's method.|Sample size was calculated to assess the non-inferiority of oral compared to intravenous hydration. We expected a primary outcome rate of 7% in the intravenous arm. We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable. Thus, 266 participants, 133 per arm, were required to ensure at least 80% power at a significance level of α = 2.5% (one-sided).||7.0|-4.8|
73968675|NCT03476460|147475639|SUPERIORITY|||||||0.299||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||Comparison between means of both arms at 24h from baseline||||0.299
73968676|NCT03476460|147475640|SUPERIORITY|||||||0.477||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||Comparison between means of both arms at 48h from baseline||||0.477
73968677|NCT03476460|147475641|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.042||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.042
73968678|NCT03476460|147475642|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.121||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.121
73968679|NCT03476460|147475643|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.418||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.418
73968680|NCT03476460|147475644|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.901||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.901
73968681|NCT03476460|147475645|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.72||||||A p-value \<0.05 (two-sided) was considered for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.720
73968682|NCT03476460|147475646|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.688||||||A p-value \<0.05 (two-sided) was considered for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.688
73968683|NCT03476460|147475647|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.535||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.535
73968684|NCT03476460|147475648|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.338||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.338
73968685|NCT03476460|147475649|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.764||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.764
73968686|NCT03476460|147475650|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.458||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.458
73925513|NCT01480076|147379688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925514|NCT01480076|147379688|SUPERIORITY_OR_OTHER|||||||0.5577|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5577
73925515|NCT01480076|147379688|SUPERIORITY_OR_OTHER||least squares mean|-6.7|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925516|NCT01480076|147379688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925517|NCT01480076|147379688|SUPERIORITY_OR_OTHER|||||||0.9365|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9365
73925518|NCT01480076|147379688|SUPERIORITY_OR_OTHER||least squares mean|-9.4|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925519|NCT01480076|147379688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925520|NCT01480076|147379688|SUPERIORITY_OR_OTHER|||||||0.2008|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2008
73925521|NCT01480076|147379688|SUPERIORITY_OR_OTHER||least squares mean|-5.1|STANDARD_ERROR_OF_MEAN|1.98||0.0102|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0102
73925522|NCT01480076|147379688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925523|NCT01480076|147379688|SUPERIORITY_OR_OTHER|||||||0.7134|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7134
73925524|NCT01480076|147379688|SUPERIORITY_OR_OTHER||least squares mean|-6.0|STANDARD_ERROR_OF_MEAN|2.2||0.0066|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0066
73925525|NCT01480076|147379688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925526|NCT01480076|147379688|SUPERIORITY_OR_OTHER|||||||0.8202|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8202
74028869|NCT00638846|147611762|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is -0.4.|Mean Difference (Final Values)|-0.0688|STANDARD_ERROR_OF_MEAN|0.1648|||TWO_SIDED|97.5|-0.0688|-0.0197|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having a lower grade fo corneal staining.||-0.0197|-0.0688|
73925527|NCT01480076|147379688|SUPERIORITY_OR_OTHER||least squares mean|-6.4|STANDARD_ERROR_OF_MEAN|2.28||0.0049|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0049
73925528|NCT01480076|147379689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925529|NCT01480076|147379689|SUPERIORITY_OR_OTHER|||||||0.1324|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1324
73925530|NCT01480076|147379689|SUPERIORITY_OR_OTHER||least squares mean|-2.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925531|NCT01480076|147379689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925532|NCT01480076|147379689|SUPERIORITY_OR_OTHER|||||||0.4759|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4759
73925533|NCT01480076|147379689|SUPERIORITY_OR_OTHER||least squares mean|-1.9|STANDARD_ERROR_OF_MEAN|0.59||0.0016|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
73925534|NCT01480076|147379689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error||||<0.0001
73925535|NCT01480076|147379689|SUPERIORITY_OR_OTHER|||||||0.2489|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2489
73925536|NCT01480076|147379689|SUPERIORITY_OR_OTHER||least squares mean|-2.2|STANDARD_ERROR_OF_MEAN|0.71||0.0017|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0017
73925537|NCT01480076|147379689|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968687|NCT03476460|147475651|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.893||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.893
73968688|NCT03476460|147475652|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.645||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.645
73968689|NCT03640312|147475680|SUPERIORITY||Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.18||Adjusting for baseline systolic blood pressure.|Mixed Models Analysis|Difference in Least Squared Means (LSM). Random participant effect, fixed baseline, study arm, and time effects.||||1.18|-10.74|0.114
73968690|NCT03640312|147475681|SUPERIORITY|Adjusted for baseline systolic blood pressure.|Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.18|||Mixed Models Analysis|||||1.18|-10.74|0.114
73968691|NCT03640312|147475682|SUPERIORITY||Mean Difference (Net)|-4.86|STANDARD_ERROR_OF_MEAN|1.87||0.012|TWO_SIDED|95.0|-8.62|-1.11||Adjusted Least Squares Mean.|Mixed Models Analysis|||Adjusted for baseline diastolic blood pressure.||-1.11|-8.62|0.012
73968692|NCT03640312|147475683|SUPERIORITY||Mean Difference (Net)|-4.86|STANDARD_ERROR_OF_MEAN|1.87||0.012|TWO_SIDED|95.0|-8.62|-1.11|||Mixed Models Analysis|||||-1.11|-8.62|0.012
73968693|NCT03640312|147475684|SUPERIORITY||Odds Ratio (OR)|2.4||||0.077|TWO_SIDED|95.0|0.91|6.35|||Mixed Models Analysis|Generalized Linear Mixed Model (binomial distribution assumption with logit link).||||6.35|0.91|0.077
73925538|NCT01480076|147379689|SUPERIORITY_OR_OTHER|||||||0.0126|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0126
73968694|NCT03640312|147475685|SUPERIORITY||Odds Ratio (OR)|0.13||||0.003|TWO_SIDED|95.0|0.03|0.48|||Regression, Logistic|||Logistic regression model adjusting for baseline systolic and diastolic blood pressure.||0.48|0.03|0.003
73968695|NCT03640312|147475686|SUPERIORITY||Odds Ratio (OR)|0.8||||0.71|TWO_SIDED|95.0|0.24|2.69|||Mixed Models Analysis|||Generalized linear mixed model adjusting for baseline systolic and diastolic blood pressure. Random participant effects. Fixed baseline systolic, diastolic, study arm, and time effects.||2.69|0.24|0.710
74028870|NCT00638846|147611763|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.368|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|97.4|0.07001|0.368|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric.||0.3680|0.07001|
73925539|NCT01480076|147379689|SUPERIORITY_OR_OTHER||least squares mean|-3.1|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925540|NCT01480076|147379689|SUPERIORITY_OR_OTHER|||||||0.0033|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0033
73925541|NCT01480076|147379689|SUPERIORITY_OR_OTHER|||||||0.1758|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1758
73925542|NCT01480076|147379689|SUPERIORITY_OR_OTHER||least squares mean|-1.9|STANDARD_ERROR_OF_MEAN|0.84||0.0246|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0246
73925543|NCT01480076|147379690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
74028871|NCT02428140|147611764|SUPERIORITY||Risk Ratio (RR)|3.29||||0.003|TWO_SIDED|95.0|1.45|7.42|||t-test, 2 sided|||||7.42|1.45|0.003
73925544|NCT01480076|147379690|SUPERIORITY_OR_OTHER|||||||0.0111|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0111
74028872|NCT02428140|147611765|SUPERIORITY||Risk Difference (RD)|10.7||||0.005|TWO_SIDED|95.0|3.4|17.9|||t-test, 2 sided|||||17.9|3.4|.005
74028873|NCT02428140|147611766|SUPERIORITY||Risk Difference (RD)|2.7||||0.28|TWO_SIDED|95.0|-1.0|6.3|||t-test, 2 sided|||||6.3|-1.0|0.28
74028874|NCT02428140|147611768|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.8|1.8||||||||1.8|-1.8|
73968696|NCT03640312|147475687|SUPERIORITY||Odds Ratio (OR)|0.64||||0.437|TWO_SIDED|95.0|0.21|1.98|||Regression, Logistic|||Logistic regression model adjusting for baseline systolic and diastolic blood pressure.||1.98|0.21|0.437
73968697|NCT03640312|147475688|SUPERIORITY||Mean Difference (Net)|-3.45|STANDARD_ERROR_OF_MEAN|2.01||0.09|TWO_SIDED|95.0|-7.49|0.59||Adjusted for baseline T score|ANCOVA|||Statistical test for difference in Physical Health T Score||0.59|-7.49|0.09
73968698|NCT03640312|147475688|SUPERIORITY||Mean Difference (Net)|0.55|STANDARD_ERROR_OF_MEAN|1.88||0.77|TWO_SIDED|95.0|-3.22|4.32||Adjusted for baseline mental health T score|ANCOVA|||Statistical test for difference in Mental Health T Score||4.32|-3.22|0.77
73968699|NCT03640312|147475689|SUPERIORITY||Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.182|||Mixed Models Analysis|||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.||1.182|-10.74|0.114
73968700|NCT03640312|147475690|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.49|TWO_SIDED|95.0|-0.15|0.02|||Fisher Exact|||||0.02|-0.15|0.49
73968701|NCT03640312|147475691|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.21|TWO_SIDED|95.0|-0.33|0.03|||Chi-squared|||||0.03|-0.33|0.21
73968702|NCT03640312|147475692|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.18|TWO_SIDED|95.0|-0.41|0.08|||Chi-squared|||||0.08|-0.41|0.18
74028875|NCT02428140|147611769|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-3.2|3.2||||||||3.2|-3.2|
74028876|NCT00945750|147611811|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the AUC geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.01||||||90.0|0.94|1.09||||||||1.09|0.94|
74028877|NCT00945750|147611812|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the Cmax geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.14||||||||1.14|0.93|
73862296|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.88||||||90.0|-7.58|-2.19|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.19|-7.58|
73862297|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82||||||90.0|-5.44|-2.2|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.20|-5.44|
73925545|NCT01480076|147379690|SUPERIORITY_OR_OTHER||least squares mean|11.1|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925546|NCT01480076|147379690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925547|NCT01480076|147379690|SUPERIORITY_OR_OTHER|||||||0.097|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0970
73925548|NCT01480076|147379690|SUPERIORITY_OR_OTHER||least squares mean|11.1|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925549|NCT01480076|147379690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925550|NCT01480076|147379690|SUPERIORITY_OR_OTHER|||||||0.0789|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0789
73925551|NCT01480076|147379690|SUPERIORITY_OR_OTHER||least squares mean|9.7|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925552|NCT01480076|147379690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925553|NCT01480076|147379690|SUPERIORITY_OR_OTHER|||||||0.0284|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0284
73925554|NCT01480076|147379690|SUPERIORITY_OR_OTHER||least squares mean|11.2|STANDARD_ERROR_OF_MEAN|2.16|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925555|NCT01480076|147379690|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925556|NCT01480076|147379690|SUPERIORITY_OR_OTHER|||||||0.0108|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0108
73968703|NCT03640312|147475693|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.56|TWO_SIDED|95.0|-0.24|0.13|||Mixed Models Analysis|||||0.13|-0.24|0.56
73925557|NCT01480076|147379690|SUPERIORITY_OR_OTHER||least squares mean|12.3|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925558|NCT01480076|147379691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925559|NCT01480076|147379691|SUPERIORITY_OR_OTHER|||||||0.8392|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8392
73925560|NCT01480076|147379691|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0162|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0162
73925561|NCT01480076|147379691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925562|NCT01480076|147379691|SUPERIORITY_OR_OTHER|||||||0.6956|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6956
73925563|NCT01480076|147379691|SUPERIORITY_OR_OTHER||least squares mean|0.06|STANDARD_ERROR_OF_MEAN|0.02||0.0042|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0042
73925564|NCT01480076|147379691|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925565|NCT01480076|147379691|SUPERIORITY_OR_OTHER|||||||0.7949|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7949
73925566|NCT01480076|147379691|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0679|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0679
73925567|NCT01480076|147379691|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
73925568|NCT01480076|147379691|SUPERIORITY_OR_OTHER|||||||0.8053|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8053
73968704|NCT03640312|147475694|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.45||0.12|TWO_SIDED|95.0|-1.61|0.19||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis|||||0.19|-1.61|0.12
73968705|NCT03640312|147475695|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.95||0.94|TWO_SIDED|95.0|-1.84|1.99||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis||The model estimated mean differences, adjusted for covariates, will not be equal to the raw mean differences observed.|||1.99|-1.84|0.94
73968706|NCT03640312|147475696|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.55|TWO_SIDED|95.0|-0.07|0.04||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis|||||0.04|-0.07|0.55
74028878|NCT00945750|147611813|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11||||||90.0|1.04|1.2||||||||1.20|1.04|
74028879|NCT00945750|147611814|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12||||||90.0|1.02|1.24||||||||1.24|1.02|
73925569|NCT01480076|147379691|SUPERIORITY_OR_OTHER||least squares mean|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.2638|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2638
73925570|NCT01480076|147379691|SUPERIORITY_OR_OTHER|||||||0.0007|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
73925571|NCT01480076|147379691|SUPERIORITY_OR_OTHER|||||||0.8502|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8502
73925572|NCT01480076|147379691|SUPERIORITY_OR_OTHER||least squares mean|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0917|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0917
73925573|NCT01480076|147379692|SUPERIORITY_OR_OTHER|||||||0.1795|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1795
73925574|NCT01480076|147379692|SUPERIORITY_OR_OTHER|||||||0.0715|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0715
73925575|NCT01480076|147379692|SUPERIORITY_OR_OTHER||least squares mean|5.8|STANDARD_ERROR_OF_MEAN|4.6||0.2065|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2065
73925576|NCT01480076|147379692|SUPERIORITY_OR_OTHER|||||||0.1649|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1649
73925577|NCT01480076|147379692|SUPERIORITY_OR_OTHER|||||||0.4894|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4894
73925578|NCT01480076|147379692|SUPERIORITY_OR_OTHER||least squares mean|1.0|STANDARD_ERROR_OF_MEAN|5.89||0.8611|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8611
73925579|NCT01480076|147379692|SUPERIORITY_OR_OTHER|||||||0.0073|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0073
73968707|NCT05093829|147475777|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup A if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||2.0|-1.0|
73968708|NCT05093829|147475777|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup A if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.8|||||TWO_SIDED|95.0|-0.6|3.7||||||For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||3.7|-0.6|
73925580|NCT01480076|147379692|SUPERIORITY_OR_OTHER|||||||0.1343|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1343
73862298|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||||90.0|-4.74|0.64|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.64|-4.74|
73862299|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76||||||90.0|-3.38|-0.15|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.15|-3.38|
73925581|NCT01480076|147379692|SUPERIORITY_OR_OTHER||least squares mean|2.3|STANDARD_ERROR_OF_MEAN|5.09||0.6468|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6468
73925582|NCT01480076|147379692|SUPERIORITY_OR_OTHER|||||||0.6441|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6441
73925583|NCT01480076|147379692|SUPERIORITY_OR_OTHER|||||||0.2176|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2176
73968709|NCT05093829|147475777|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup C if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-0.5|||||TWO_SIDED|95.0|-2.3|1.9||||||For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||1.9|-2.3|
73968710|NCT05093829|147475777|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup C if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-0.8|||||TWO_SIDED|95.0|-3.3|2.5||||||For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||2.5|-3.3|
73968711|NCT05093829|147475777|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup W if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-3.0|||||TWO_SIDED|95.0|-6.3|0.8||||||For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||0.8|-6.3|
73968712|NCT05093829|147475777|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup W if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.3|||||TWO_SIDED|95.0|-1.8|3.5||||||For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||3.5|-1.8|
74028880|NCT02531035|147611817|SUPERIORITY||Percentage difference|13.4|||<|0.001|TWO_SIDED|95.0|8.97|17.81||P-values from Cochran-Mantel-Haenszel test stratified by different levels of stratification factors of BMI at Screening(\<25 kg/m\^2,\>=25 kg/m\^2),Week -2 A1C(\<=9.0%, \>9.0%),and using continuous subcutaneous insulin infusion(CSII) at Screening(yes,no).|Cochran-Mantel-Haenszel|||||17.81|8.97|< 0.001
74028881|NCT02531035|147611818|SUPERIORITY||Least Squares Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.54|-0.38|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m\^2, \>=25 kg/m\^2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.38|-0.54|< 0.001
73862300|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08||||||90.0|-4.77|0.62|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.62|-4.77|
73968713|NCT05093829|147475777|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup Y if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-3.0|||||TWO_SIDED|95.0|-5.4|-0.4||||||For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||-0.4|-5.4|
73925584|NCT01480076|147379692|SUPERIORITY_OR_OTHER||least squares mean|8.5|STANDARD_ERROR_OF_MEAN|7.91||0.2814|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2814
73925585|NCT01480076|147379692|SUPERIORITY_OR_OTHER|||||||0.7533|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7533
73925586|NCT01480076|147379692|SUPERIORITY_OR_OTHER|||||||0.0653|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0653
73925587|NCT01480076|147379692|SUPERIORITY_OR_OTHER||least squares mean|11.4|STANDARD_ERROR_OF_MEAN|6.65||0.0876|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0876
73925588|NCT01480076|147379693|SUPERIORITY_OR_OTHER|||||||0.0281|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0281
73925589|NCT01480076|147379693|SUPERIORITY_OR_OTHER|||||||0.0654|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0654
73925590|NCT01480076|147379693|SUPERIORITY_OR_OTHER||least squares mean|4.3|STANDARD_ERROR_OF_MEAN|4.47||0.34|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3400
73925591|NCT01480076|147379693|SUPERIORITY_OR_OTHER|||||||0.0012|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0012
73925592|NCT01480076|147379693|SUPERIORITY_OR_OTHER|||||||0.749|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7490
73925593|NCT01480076|147379693|SUPERIORITY_OR_OTHER||least squares mean|-5.1|STANDARD_ERROR_OF_MEAN|5.53||0.3592|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3592
73925594|NCT01480076|147379693|SUPERIORITY_OR_OTHER|||||||0.0015|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0015
73925595|NCT01480076|147379693|SUPERIORITY_OR_OTHER|||||||0.2967|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2967
73925596|NCT01480076|147379693|SUPERIORITY_OR_OTHER||least squares mean|-0.9|STANDARD_ERROR_OF_MEAN|5.34||0.8735|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8735
73925597|NCT01480076|147379693|SUPERIORITY_OR_OTHER|||||||0.1696|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1696
73968714|NCT05093829|147475777|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup Y if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|1.4|||||TWO_SIDED|95.0|-0.6|4.8||||||For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||4.8|-0.6|
73968715|NCT05093829|147475778|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval (CI) for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). The CI is estimated using bootstrap resampling stratified by vaccine arm, and the 95% CI is estimated as the interval between the 2.5th and 97.5th percentiles of the bootstrap empirical distribution. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|2.3|||||TWO_SIDED|95.0|0.3|4.7||||||For the 9-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup W is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.||4.7|0.3|
73968716|NCT05093829|147475778|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval (CI) for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). The CI is estimated using bootstrap resampling stratified by vaccine arm, and the 95% CI is estimated as the interval between the 2.5th and 97.5th percentiles of the bootstrap empirical distribution. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|1.9|||||TWO_SIDED|95.0|0.004|4.4||||||For the 15-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup Y is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.||4.4|0.004|
73968717|NCT05093829|147475782|SUPERIORITY|NmCV-5 will be deemed superior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes 0.30 (30%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|82.5|||||TWO_SIDED|95.0|76.4|87.2||||||For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||87.2|76.4|
73968718|NCT05093829|147475782|SUPERIORITY|NmCV-5 will be deemed superior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes 0.30 (30%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|68.4|||||TWO_SIDED|95.0|61.3|74.7||||||For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||74.7|61.3|
74028882|NCT02531035|147611819|SUPERIORITY||Least squares mean difference|-2.98|||<|0.001|TWO_SIDED|95.0|-3.31|-2.66|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m\^2, \>=25 kg/m\^2), randomization stratum of Week -2 A1C (\<=9%, \>9%), randomization stratum of Use of CSII at Screening (Yes, No), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline weight-by-time interaction as a covariate.||-2.66|-3.31|< 0.001
74028883|NCT02531035|147611820|SUPERIORITY||Least Squares Mean Difference|-3.5|||=|0.002|TWO_SIDED|95.0|-5.7|-1.3|||MMRM|||Testing according to the hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m2, \>=25 kg/m2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by- time interaction as fixed categorical effects, and Baseline SBP-by-time interaction as a covariate.||-1.3|-5.7|= 0.002
74028884|NCT02531035|147611821|SUPERIORITY||Least squares mean difference|-12.32|||<|0.001|TWO_SIDED|95.0|-18.17|-6.48|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m2, \>=25 kg/m2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-6.48|-18.17|< 0.001
74087240|NCT02260258|147728416|EQUIVALENCE|Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes patients surviving to discontinuation of mechanical ventilation (n=14 in each group). Two patients discharged from the hospital on mechanical ventilation have duration truncated at time of discharge and are considered survivors to extubation. Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.4||||0.32|TWO_SIDED|95.0|0.7|2.9|||Regression, Linear|Duration log transformed and so parameter estimate represents geometric mean difference.||Anaysis for the patients surviving to extubation (n= 14 in both groups)||2.9|0.7|0.32
74087241|NCT02260258|147728417|EQUIVALENCE|Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios|Odds Ratio (OR)|1.3||||0.63|TWO_SIDED|95.0|0.5|3.3|||Regression, Logistic|||||3.3|0.5|0.63
73925598|NCT01480076|147379693|SUPERIORITY_OR_OTHER|||||||0.0089|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0089
73862301|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||||90.0|-2.49|0.74|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.74|-2.49|
73925599|NCT01480076|147379693|SUPERIORITY_OR_OTHER||least squares mean|14.9|STANDARD_ERROR_OF_MEAN|6.83||0.0297|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0297
73925600|NCT01480076|147379693|SUPERIORITY_OR_OTHER|||||||0.8806|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8806
73925601|NCT01480076|147379693|SUPERIORITY_OR_OTHER|||||||0.217|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2170
73925602|NCT01480076|147379693|SUPERIORITY_OR_OTHER||least squares mean|8.1|STANDARD_ERROR_OF_MEAN|6.86||0.2392|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2392
73968719|NCT05093829|147475783|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to measles if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.||2.0|-1.0|
73925603|NCT01480076|147379694|SUPERIORITY_OR_OTHER|||||||0.0219|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0219
73925604|NCT01480076|147379694|SUPERIORITY_OR_OTHER|||||||0.1259|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1259
73925605|NCT01480076|147379694|SUPERIORITY_OR_OTHER||least squares mean|3.6|STANDARD_ERROR_OF_MEAN|5.68||0.5312|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5312
73925606|NCT01480076|147379694|SUPERIORITY_OR_OTHER|||||||0.0022|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0022
73925607|NCT01480076|147379694|SUPERIORITY_OR_OTHER|||||||0.4968|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4968
73968720|NCT05093829|147475783|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to measles if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.1||||||For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.||2.1|-1.0|
73968721|NCT05093829|147475784|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to rubella if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|-4.3|||||TWO_SIDED|95.0|-10.5|2.6||||||For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.||2.6|-10.5|
73925608|NCT01480076|147379694|SUPERIORITY_OR_OTHER||least squares mean|-3.2|STANDARD_ERROR_OF_MEAN|6.64||0.6283|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6283
73925609|NCT01480076|147379694|SUPERIORITY_OR_OTHER|||||||0.0016|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
73925610|NCT01480076|147379694|SUPERIORITY_OR_OTHER|||||||0.6631|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6631
73925611|NCT01480076|147379694|SUPERIORITY_OR_OTHER||least squares mean|-4.8|STANDARD_ERROR_OF_MEAN|6.77||0.477|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4770
73925612|NCT01480076|147379694|SUPERIORITY_OR_OTHER|||||||0.4027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4027
73925613|NCT01480076|147379694|SUPERIORITY_OR_OTHER|||||||0.1077|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1077
73925614|NCT01480076|147379694|SUPERIORITY_OR_OTHER||least squares mean|13.5|STANDARD_ERROR_OF_MEAN|9.98||0.1781|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1781
73925615|NCT01480076|147379694|SUPERIORITY_OR_OTHER|||||||0.2422|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2422
73925616|NCT01480076|147379694|SUPERIORITY_OR_OTHER|||||||0.0994|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0994
73925617|NCT01480076|147379694|SUPERIORITY_OR_OTHER||least squares mean|8.8|STANDARD_ERROR_OF_MEAN|7.13||0.2194|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2194
73925618|NCT01480076|147379695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925619|NCT01480076|147379695|SUPERIORITY_OR_OTHER|||||||0.086|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0860
73925620|NCT01480076|147379695|SUPERIORITY_OR_OTHER||least squares mean|-7.3|STANDARD_ERROR_OF_MEAN|2.2||0.001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0010
73925621|NCT01480076|147379695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
74087242|NCT02260258|147728418|EQUIVALENCE|Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios|Odds Ratio (OR)|1.7||||0.35|TWO_SIDED|95.0|0.6|4.7|||Regression, Logistic|||||4.7|0.6|0.35
73968722|NCT05093829|147475784|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to rubella if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.1||||||For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.||2.1|-1.0|
73968723|NCT05093829|147475785|NON_INFERIORITY|The NmCV-5 co-administered yellow fever vaccine will be deemed non-inferior to the MenACWY-TT co-administered yellow fever vaccine in eliciting seroprotective response to yellow fever if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|-1.9|||||TWO_SIDED|95.0|-4.2|0.6||||||For this comparison, the proportion of infants with a seroprotective response to yellow fever vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seroprotective response to yellow fever vaccine in the NmCV-5 arm to determine the difference in proportions.||0.6|-4.2|
73968724|NCT05093829|147475786|OTHER||Ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.8|
73968725|NCT05093829|147475786|OTHER||Ratio of geometric mean titers|1.2|||||TWO_SIDED|95.0|1.0|1.6|||||NmCV-5 divided by MenACWY-TT|For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.6|1.0|
73968726|NCT05093829|147475786|OTHER||Ratio of geometric mean titers|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||NmCV-5 divided by MenACWY-TT|For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||0.6|0.4|
73968727|NCT05093829|147475786|OTHER||Ratio of geometric mean titers|0.4|||||TWO_SIDED|95.0|0.3|0.5|||||NmCV-5 divided by MenACWY-TT|For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||0.5|0.3|
73968728|NCT05093829|147475786|OTHER||Ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.6|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.6|
73968729|NCT05093829|147475786|OTHER||Ratio of geometric mean titers|1.6|||||TWO_SIDED|95.0|1.1|2.1|||||NmCV-5 divided by MenACWY-TT|For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||2.1|1.1|
73968730|NCT05093829|147475786|OTHER||Ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.6|1.0|||||NmCV-5 divided by MenACWY-TT|For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.0|0.6|
74028885|NCT00500149|147611840|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose||||<0.0001
74028886|NCT00500149|147611840|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose||||<0.0001
74028887|NCT00500149|147611840|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose||||<0.0001
74028888|NCT00500149|147611840|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose||||<0.0001
74028889|NCT00500149|147611840|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose||||<0.0001
74028890|NCT00500149|147611840|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose||||<0.0001
74028891|NCT00500149|147611840|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose||||<0.0001
74028892|NCT00500149|147611841|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose||||< 0.0001
74087243|NCT01886937|147728425|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
74087244|NCT03314662|147728430|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5|GMT ratio (aTIV/aQIV)|1.16|||||TWO_SIDED|95.0|1.05|1.27|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aTIV/aQIV - for strain A/H1N1||1.27|1.05|
74087245|NCT03314662|147728430|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5|GMT ratio: (aTIV/aQIV|0.99|||||TWO_SIDED|95.0|0.9|1.09|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log 10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aTIV/aQIV - performed for strain A/H3N2||1.09|0.90|
74087246|NCT03314662|147728430|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5.|GMT ratio: aTIV/aQIV|0.99|||||TWO_SIDED|95.0|0.9|1.08|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aQIV/aTIV - performed for strain B/Yamagata||1.08|0.90|
74087247|NCT03314662|147728430|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5.|GMT ratio: (aTIV/aQIV)]|0.98|||||TWO_SIDED|95.0|0.89|1.08|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aQIV/aTIV - performed for strain B/Victoria||1.08|0.89|
73862302|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||||90.0|-4.99|0.39|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.39|-4.99|
73925622|NCT01480076|147379695|SUPERIORITY_OR_OTHER|||||||0.2777|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2777
73925623|NCT01480076|147379695|SUPERIORITY_OR_OTHER||least squares mean|-10.4|STANDARD_ERROR_OF_MEAN|2.76||0.0002|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
74028893|NCT00500149|147611841|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose||||<0.0001
74028894|NCT00500149|147611841|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose||||<0.0001
74087248|NCT03314662|147728431|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)|3.23|||||TWO_SIDED|95.0|-1.3|7.76||||||Comparison Group Selection: aTIV minus aQIV - for strain A/H1N1||7.76|-1.30|
74087249|NCT03314662|147728431|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)|0.37|||||TWO_SIDED|95.0|-4.23|4.96||||||Comparison Group Selection: aTIV minus aQIV - for strain A/H3N2||4.96|-4.23|
74087250|NCT03314662|147728431|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)]|-0.93|||||TWO_SIDED|95.0|-5.13|3.27||||||Comparison Group Selection: aTIV minus aQIV - for strain B-Yamagata||3.27|-5.13|
73862303|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||||90.0|-2.47|0.77|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.77|-2.47|
73862304|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.22||||||90.0|-6.91|-1.52|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.52|-6.91|
73862305|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.51||||||90.0|-4.13|-0.9|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.90|-4.13|
73862306|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||||90.0|-4.63|0.76|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.76|-4.63|
73862307|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32||||||90.0|-3.94|-0.7|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.70|-3.94|
73925624|NCT01480076|147379695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925625|NCT01480076|147379695|SUPERIORITY_OR_OTHER|||||||0.1078|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1078
73925626|NCT01480076|147379695|SUPERIORITY_OR_OTHER||least squares mean|-7.6|STANDARD_ERROR_OF_MEAN|2.87||0.0082|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0082
74028895|NCT00500149|147611841|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose||||<0.0001
73862308|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.36||||||90.0|-8.22|-0.5|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.50|-8.22|
73862309|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.93||||||90.0|-6.29|-1.56|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.56|-6.29|
73862310|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.91||||||90.0|-10.77|-3.05|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-3.05|-10.77|
73925627|NCT01480076|147379695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968731|NCT05093829|147475786|OTHER||Ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.8|
73925628|NCT01480076|147379695|SUPERIORITY_OR_OTHER|||||||0.1838|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1838
73925629|NCT01480076|147379695|SUPERIORITY_OR_OTHER||least squares mean|-6.3|STANDARD_ERROR_OF_MEAN|3.02||0.0364|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0364
73925630|NCT01480076|147379695|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925631|NCT01480076|147379695|SUPERIORITY_OR_OTHER|||||||0.1714|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1714
73925632|NCT01480076|147379695|SUPERIORITY_OR_OTHER||least squares mean|-4.8|STANDARD_ERROR_OF_MEAN|3.14||0.1259|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1259
73925633|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925634|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925635|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925636|NCT01480076|147379696|SUPERIORITY_OR_OTHER|||||||0.0004|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0004
73925637|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925638|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925639|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925640|NCT01480076|147379696|SUPERIORITY_OR_OTHER|||||||0.0069|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0069
73925641|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925642|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
74028896|NCT00500149|147611841|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose||||<0.0001
74028897|NCT00500149|147611841|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose||||<0.001
73925643|NCT01480076|147379696|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
73925644|NCT01480076|147379696|SUPERIORITY_OR_OTHER|||||||0.0006|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0006
73925645|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925646|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925647|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925648|NCT01480076|147379696|SUPERIORITY_OR_OTHER|||||||0.004|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0040
73968732|NCT05093829|147475786|OTHER||Ratio of geometric mean titers|1511.1|||||TWO_SIDED|95.0|1169.5|1952.4|||||NmCV-5 divided by MenACWY-TT|For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1952.4|1169.5|
73968733|NCT05093829|147475786|OTHER||Ratio of geometric mean titers|767.3|||||TWO_SIDED|95.0|553.2|1064.4|||||NmCV-5 divided by MenACWY-TT|For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1064.4|553.2|
73968734|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|2756.4|||||TWO_SIDED|95.0|1976.3|3844.5|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3844.5|1976.3|
74028898|NCT00500149|147611841|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose||||<0.0001
74028899|NCT00521339|147611864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
73925649|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73968735|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|2506.9|||||TWO_SIDED|95.0|1404.0|4476.1|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||4476.1|1404.0|
73925650|NCT01480076|147379696|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925651|NCT01480076|147379696|SUPERIORITY_OR_OTHER|||||||0.0047|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0047
73925652|NCT01480076|147379696|SUPERIORITY_OR_OTHER|||||||0.0118|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0118
74028900|NCT00521339|147611865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
74028901|NCT00521339|147611866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
74028902|NCT00521339|147611867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74028903|NCT00521339|147611868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.632|||||||Wilcoxon (Mann-Whitney)|||||||0.632
74028904|NCT00521339|147611869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||||||0.242
74028905|NCT00521339|147611870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329|||||||Wilcoxon (Mann-Whitney)|||||||0.329
74028906|NCT00521339|147611871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.130
74028907|NCT00521339|147611873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.008
74028908|NCT00521339|147611874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
74028909|NCT00521339|147611875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
74028910|NCT00521339|147611877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
73925653|NCT01480076|147379697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925654|NCT01480076|147379697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925655|NCT01480076|147379697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925656|NCT01480076|147379697|SUPERIORITY_OR_OTHER|||||||0.1398|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1398
73925657|NCT01480076|147379697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925658|NCT01480076|147379697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925659|NCT01480076|147379697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925660|NCT01480076|147379697|SUPERIORITY_OR_OTHER|||||||0.0935|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0935
73925661|NCT01480076|147379697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925662|NCT01480076|147379697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
74028911|NCT00521339|147611878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
73925663|NCT01480076|147379697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
74028912|NCT00521339|147611879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
74028913|NCT00521339|147611880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
73925664|NCT01480076|147379697|SUPERIORITY_OR_OTHER|||||||0.076|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0760
74028914|NCT00521339|147611881|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74028915|NCT00521339|147611882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
74028916|NCT00521339|147611883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
74028917|NCT00521339|147611884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539|||||||Wilcoxon (Mann-Whitney)|||||||0.539
74028918|NCT00521339|147611885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
74028919|NCT00521339|147611886|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|||||||0.339
74028920|NCT00521339|147611887|SUPERIORITY_OR_OTHER_LEGACY|||||||0.898|||||||Wilcoxon (Mann-Whitney)|||||||0.898
74028921|NCT00521339|147611888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
74028922|NCT00089843|147611899|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|3.2|||<|0.0001|TWO_SIDED|95.0|1.8|4.6||This p value was for the effect of Actonel (risedronate) on bone mineral density of the spine.|Factorial analysis|||Factorial analysis||4.6|1.8|<0.0001
74028923|NCT00089843|147611899|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-0.6||||0.41|TWO_SIDED|95.0|-2.0|0.8||This p value was for the effect of testosterone on bone mineral density of the spine.|Factorial analysis|||Factorial analysis||0.8|-2.0|0.41
74028924|NCT00089843|147611900|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-41.0||||0.002|TWO_SIDED|95.0||||This p value was for the effect of Actonel (risedronate).|Factorial analysis|||Factorial analysis||||0.002
73925665|NCT01480076|147379697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925666|NCT01480076|147379697|SUPERIORITY_OR_OTHER|||||||0.0019|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0019
73925667|NCT01480076|147379697|SUPERIORITY_OR_OTHER|||||||0.0037|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0037
73925668|NCT01480076|147379697|SUPERIORITY_OR_OTHER|||||||0.2489|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2489
73925669|NCT01480076|147379697|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925670|NCT01480076|147379697|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
73925671|NCT01480076|147379697|SUPERIORITY_OR_OTHER|||||||0.0052|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0052
73925672|NCT01480076|147379697|SUPERIORITY_OR_OTHER|||||||0.7714|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7714
73925673|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925674|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925675|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925676|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925677|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
74028925|NCT00089843|147611900|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-11.0||||0.39||95.0||||This p value was for the effect of testosterone.|Factorial analysis|||Factorial analysis||||0.39
73925678|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925679|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925680|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
74028926|NCT03567291|147611975|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.78|TWO_SIDED|95.0|-3.4|2.6|||ANCOVA|||||2.6|-3.4|0.78
73925681|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925682|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925683|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925684|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925685|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
74087251|NCT03314662|147728431|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|Other [SCR difference (aTIV minus aQIV)]|-1.26|||||TWO_SIDED|95.0|-5.07|2.55||||||Comparison Group Selection: aTIV minus aQIV - for strain B-Victoria||2.55|-5.07|
73925686|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
74087252|NCT03314662|147728434|SUPERIORITY|Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was \<1. The superiority comparison was based on the Full Analysis Set (FAS) Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22.|GMT ratio|0.64|||||TWO_SIDED|95.0|0.58|0.7||||||B/Yamagata strain: GMT Ratio (aTIV/aQIV)||0.70|0.58|
73925687|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925688|NCT01480076|147379698|SUPERIORITY_OR_OTHER|||||||0.0009|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0009
73925689|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925690|NCT01480076|147379698|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925691|NCT01480076|147379698|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
73925692|NCT01480076|147379698|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
73925693|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925694|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925695|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
74087253|NCT03314662|147728434|SUPERIORITY|Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was \<1. The superiority comparison was based on the FAS Immunogenicity.|GMT ratio|0.71|||||TWO_SIDED|95.0|0.64|0.78||||||B/Victoria Strain: GMT Ratio (aTIV/aQIV)||0.78|0.64|
74087254|NCT03314662|147728437|SUPERIORITY|Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was \<0, for both B strains. The superiority comparison was based on the FAS Immunogenicity.|SCR difference|-11.96|||||TWO_SIDED|95.0|-15.12|-8.81||||||B/Yamagata Strain: SCR Difference (aTIV-1 - aQIV).||-8.81|-15.12|
74087255|NCT03314662|147728437|SUPERIORITY|Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was \<0, for both B strains. The superiority comparison was based on the FAS Immunogenicity.|SCR difference|-10.82|||||TWO_SIDED|95.0|-13.54|-8.11||||||B/Victoria Strain: SCR Difference (aTIV-2 - aQIV)||-8.11|-13.54|
74087256|NCT00925301|147728446|SUPERIORITY||Difference|12.5||||0.2996|TWO_SIDED|95.0|-13.4|37.3|||Cochran-Mantel-Haenszel|p-value from Cochran-Mantel-Haenszel test stratified by sex|The difference between the percentage of successes between migalastat and placebo treatment groups|||37.3|-13.4|0.2996
74087257|NCT00925301|147728449|OTHER|Mixed effects model for repeated measures (MMRM) approach with fixed effects of treatment, time (Month 6 and Month 12), mutation type (amenable or non-amenable), time by treatment interaction, time by mutation type interaction, and the baseline value as a covariate. An unstructured covariance matrix to account for repeated measures within a participant was assumed.||||||0.014||||||Significant at the 0.050 level|MMRM|||||||0.014
73862311|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.79||||||90.0|-8.15|-3.42|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-3.42|-8.15|
73862312|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8||||||90.0|-9.66|-1.94|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.94|-9.66|
73925696|NCT01480076|147379699|SUPERIORITY_OR_OTHER|||||||0.0032|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0032
73925697|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925698|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925699|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925700|NCT01480076|147379699|SUPERIORITY_OR_OTHER|||||||0.0021|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0021
73925701|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
74087258|NCT00925301|147728450|OTHER||Difference LSMeans|-0.3||||0.0078|TWO_SIDED|95.0|-0.6|-0.1||Significant at the 0.010 level|ANCOVA|||The change from Baseline in the average number of kidney ICs was analyzed using an ANCOVA model with covariate adjustment for the baseline value and factors for treatment group and the treatment by baseline interaction.||-0.1|-0.6|0.0078
74087259|NCT01117766|147728451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.537||0.7319|TWO_SIDED|95.0|-1.29|0.92|||ANCOVA|||Week 3 (Visits 3 and 6)||0.92|-1.29|0.7319
74087260|NCT01117766|147728451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.536||0.3404|TWO_SIDED|95.0|-1.61|0.57|||ANCOVA|||Week 4 (Visits 4 and 7)||0.57|-1.61|0.3404
74087261|NCT01117766|147728452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.32|STANDARD_ERROR_OF_MEAN|26.872||0.6539|TWO_SIDED|95.0|-70.2|45.56|||ANCOVA|||Week 3 (Visits 3 and 6)||45.56|-70.20|0.6539
74087262|NCT01117766|147728452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.91|STANDARD_ERROR_OF_MEAN|25.807||0.3678|TWO_SIDED|95.0|-78.54|30.72|||ANCOVA|||Week 4 (Visits 4 and 7)||30.72|-78.54|0.3678
74087263|NCT01117766|147728453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.342||0.0071|TWO_SIDED|95.0|-1.84|-0.35|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||-0.35|-1.84|0.0071
73925702|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925703|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925704|NCT01480076|147379699|SUPERIORITY_OR_OTHER|||||||0.0097|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0097
73925705|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925706|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73862313|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.65||||||90.0|-9.01|-4.29|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-4.29|-9.01|
73925707|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925708|NCT01480076|147379699|SUPERIORITY_OR_OTHER|||||||0.0103|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0103
73925709|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925710|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925711|NCT01480076|147379699|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925712|NCT01480076|147379699|SUPERIORITY_OR_OTHER|||||||0.1227|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1227
73925713|NCT01480076|147379700|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925714|NCT01480076|147379700|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925715|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.1754|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1754
73925716|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.0192|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0192
73968736|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|1179.0|||||TWO_SIDED|95.0|709.8|1958.6|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1958.6|709.8|
73925717|NCT01480076|147379700|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925718|NCT01480076|147379700|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925719|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
73925720|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.0157|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0157
73925721|NCT01480076|147379700|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925722|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
73925723|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.1012|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1012
73925724|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.0749|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0749
73925725|NCT01480076|147379700|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925726|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.0455|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0455
73925727|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.4699|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4699
74028927|NCT01103349|147611976|SUPERIORITY||Adjusted mean treatment differences|3.87|STANDARD_DEVIATION|1.494||0.005|TWO_SIDED|95.0|0.931|6.809||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (BI671800 ED 400 mg bid) ≤ Mean FEV1 % predicted trough change from baseline (placebo)||6.809|0.931|0.0050
73925728|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.0235|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0235
73925729|NCT01480076|147379700|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925730|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.1978|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1978
73925731|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.1977|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1977
73925732|NCT01480076|147379700|SUPERIORITY_OR_OTHER|||||||0.225|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2250
73925733|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925734|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925735|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925736|NCT01480076|147379701|SUPERIORITY_OR_OTHER|||||||0.0649|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0649
73925737|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925738|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925739|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925740|NCT01480076|147379701|SUPERIORITY_OR_OTHER|||||||0.1138|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1138
73925741|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925742|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925743|NCT01480076|147379701|SUPERIORITY_OR_OTHER|||||||0.0003|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0003
73925744|NCT01480076|147379701|SUPERIORITY_OR_OTHER|||||||0.185|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1850
73925745|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925746|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968737|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|1096.2|||||TWO_SIDED|95.0|513.4|2340.6|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2340.6|513.4|
73968738|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|288.7|||||TWO_SIDED|95.0|212.6|392.0|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||392.0|212.6|
74087264|NCT01117766|147728453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|0.37||0.1294|TWO_SIDED|95.0|-1.36|0.19|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.19|-1.36|0.1294
73925747|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925748|NCT01480076|147379701|SUPERIORITY_OR_OTHER|||||||0.0887|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0887
73925749|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925750|NCT01480076|147379701|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925751|NCT01480076|147379701|SUPERIORITY_OR_OTHER|||||||0.0011|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0011
73925752|NCT01480076|147379701|SUPERIORITY_OR_OTHER|||||||0.1853|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1853
73925753|NCT01480076|147379702|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925754|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0005|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0005
73925755|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
73925756|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0167|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0167
73925757|NCT01480076|147379702|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
74028928|NCT01103349|147611976|SUPERIORITY||Adjusted mean treatment differences|2.369|STANDARD_DEVIATION|1.567||0.0657||95.0|-0.713|5.452||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd) ≤ Mean FEV1 % predicted trough change from baseline (placebo)||5.452|-0.713|0.0657
73925758|NCT01480076|147379702|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925759|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0024|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0024
73925760|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0669|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0669
73925761|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0018|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0018
74087265|NCT01117766|147728454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.54|STANDARD_ERROR_OF_MEAN|25.298||0.03|TWO_SIDED|95.0|-116.12|-6.96|||ANCOVA|||Week 3 (Visits 3 and 6)||-6.96|-116.12|0.0300
73925762|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0004|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
73925763|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.019|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0190
73925764|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0106|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0106
73925765|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0009|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0009
73925766|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.1937|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1937
73925767|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0445|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0445
73925768|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.6475|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6475
73925769|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0097|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0097
73925770|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0386|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0386
73925771|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0219|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0219
73925772|NCT01480076|147379702|SUPERIORITY_OR_OTHER|||||||0.0076|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0076
73925773|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.1471|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1471
73925774|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.5503|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5503
73925775|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.3854|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3854
74087266|NCT01117766|147728454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.06|STANDARD_ERROR_OF_MEAN|26.501||0.0844|TWO_SIDED|95.0|-105.67|7.55|||ANCOVA|||Week 4 (Visits 4 and 7)||7.55|-105.67|0.0844
73925776|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.4893|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4893
73925777|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.2166|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2166
74028929|NCT01103349|147611976|SUPERIORITY||Adjusted mean treatment differences|1.501|STANDARD_DEVIATION|1.602||0.1748|TWO_SIDED|95.0|-1.652|4.653||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (BI671800 ED 400 mg bid) ≤ Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd)||4.653|-1.652|0.1748
73925778|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.4149|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4149
73925779|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.3849|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3849
73925780|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.898|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8980
73925781|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.0046|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0046
73925782|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.0594|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0594
73925783|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.2975|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2975
73925784|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.7155|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7155
73925785|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.507|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5070
74028930|NCT01103349|147611977|SUPERIORITY||Adjusted mean treatment differences|-0.28|STANDARD_DEVIATION|0.118||0.0092|TWO_SIDED|95.0|-0.512|-0.048||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||-0.048|-0.512|0.0092
74028931|NCT01103349|147611977|SUPERIORITY||Adjusted mean treatment differences|-0.18|STANDARD_DEVIATION|0.124||0.0732|TWO_SIDED|95.0|-0.423|0.063||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.063|-0.423|0.0732
74028932|NCT01103349|147611977|SUPERIORITY||Adjusted mean treatment differences|-0.1|STANDARD_DEVIATION|0.126||0.2139|TWO_SIDED|95.0|-0.347|0.147||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.147|-0.347|0.2139
74028933|NCT00090285|147611978|SUPERIORITY_OR_OTHER||Risk Difference (RD)|90.6||||||95.0|70.1|98.2|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter.|||98.2|70.1|
74028934|NCT00090285|147611986|SUPERIORITY_OR_OTHER||Risk Difference (RD)|77.5||||||95.0|39.6|93.3||||||||93.3|39.6|
74028935|NCT00090285|147611987|SUPERIORITY_OR_OTHER||Risk Difference (RD)|85.5||||||95.0|77.0|91.3|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.|||91.3|77.0|
74028936|NCT00090285|147611988|SUPERIORITY_OR_OTHER||Risk Difference (RD)|51.0||||||95.0|40.3|59.9|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.|||59.9|40.3|
73925786|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.5848|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5848
73925787|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.802|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8020
74028937|NCT02639182|147612007|SUPERIORITY|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.||||||0.983||||||The stratification factors were the ECOG PS at baseline and the number of prior systemic renal cell carcinoma (RCC) regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|||||||0.983
74028938|NCT02639182|147612008|SUPERIORITY|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.|Hazard Ratio (HR)|1.423||||0.11|TWO_SIDED|95.0|0.924|2.192||The stratification factors were the ECOG PS at baseline and the number of prior systemic RCC regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|||||2.192|0.924|0.110
74028939|NCT02639182|147612009|SUPERIORITY||Odds Ratio (OR)|0.4||||0.062|TWO_SIDED|95.0|0.1|1.1||A Cochran-Mantel-Haenszel (CMH) analysis of the ORR, stratified for baseline ECOG-PS and number of prior systemic therapies for RCC, was conducted at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Stratified Mantel-Haenszel estimate of the odds ratio for experiencing objective response, with the axitinib arm as the reference level, was reported.||||1.1|0.1|0.062
74028940|NCT02639182|147612010|SUPERIORITY||Hazard Ratio (HR)|0.376||||0.439||95.0|0.031|4.482||The stratification factors were the ECOG PS at baseline and the number of prior systemic RCC regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.||||4.482|0.031|0.439
74028941|NCT02639182|147612011|SUPERIORITY|||||||0.746||||||Test conducted at a 2-sided significance level of 0.05. The stratification factors were the ECOG PS at baseline and number of prior systemic RCC regimens.|Log Rank|||||||0.746
74028942|NCT02639182|147612012|SUPERIORITY|A CMH analysis of the DCR, stratified for baseline ECOG-PS and number of prior systemic therapies for RCC, was conducted at a two-sided significance level of 0.05.|Odds Ratio (OR)|0.5||||0.152|TWO_SIDED|95.0|0.2|1.3||The stratified Mantel-Haenszel estimate of the odds ratio for experiencing objective response, with the axitinib arm as the reference level, was reported as a measure of relative treatment effect, along with its two-sided 95% CI.|Cochran-Mantel-Haenszel|||||1.3|0.2|0.152
74028943|NCT03069690|147612029|SUPERIORITY||Mean Difference (Net)|-0.3996|STANDARD_ERROR_OF_MEAN|2.665||0.8|TWO_SIDED|95.0|-5.649|4.85||The value was not adjusted for multiple comparisons.|ANCOVA|||||4.850|-5.649|.80
73925788|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.254|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2540
73925789|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.9057|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9057
73925790|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.9679|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9679
73925791|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.5875|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5875
73925792|NCT01480076|147379703|SUPERIORITY_OR_OTHER|||||||0.744|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7440
73925793|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.0032|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0032
73925794|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.0828|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0828
73925795|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.7756|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7756
73925796|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.22|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2200
73925797|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
73925798|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.0061|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0061
73925799|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.6258|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6258
73925800|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.6987|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6987
73925801|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.0025|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0025
73925802|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.0021|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0021
73925803|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.4385|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4385
73925804|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.2275|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2275
73925805|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.0446|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0446
73925806|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.5757|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5757
73925807|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.8936|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8936
74028944|NCT03069690|147612029|SUPERIORITY||Mean Difference (Net)|-3.387|STANDARD_ERROR_OF_MEAN|2.755||0.8|TWO_SIDED|95.0|-8.813|2.039||The value was not adjusted for multiple comparisons.|ANCOVA|||||2.039|-8.813|.80
73925808|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.5675|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5675
73925809|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.2539|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2539
73925810|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.6673|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6673
73925811|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.0849|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0849
73925812|NCT01480076|147379704|SUPERIORITY_OR_OTHER|||||||0.1187|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1187
74028945|NCT03069690|147612029|SUPERIORITY||Mean Difference (Net)|-1.1729|STANDARD_ERROR_OF_MEAN|2.72||0.8|TWO_SIDED|95.0|-6.53|4.184||The value was not adjusted for multiple comparisons.|ANCOVA|||||4.184|-6.530|.80
73925813|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.0022|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0022
73925814|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.0299|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0299
73925815|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.8135|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8135
73925816|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.3526|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3526
73925817|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
73925818|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.0039|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0039
73925819|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.6924|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6924
73925820|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.7639|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7639
73925821|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.0013|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0013
73925822|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.0011|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0011
73925823|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.434|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4340
73925824|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.4224|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4224
73925825|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.1628|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1628
73925826|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.5666|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5666
73968739|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|654.5|||||TWO_SIDED|95.0|385.5|1111.0|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1111.0|385.5|
73968740|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|287.9|||||TWO_SIDED|95.0|213.9|387.5|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||387.5|213.9|
74028946|NCT00591227|147612035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||t-test, 1 sided|||||||0.58
73925827|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.8315|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8315
73925828|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.3852|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3852
74028947|NCT00117338|147612055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.775||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.08|-0.06|0.775
73925829|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.0652|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0652
73925830|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.5719|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5719
73925831|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.9237|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9237
73925832|NCT01480076|147379705|SUPERIORITY_OR_OTHER|||||||0.131|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1310
73925833|NCT01480076|147379706|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925834|NCT01480076|147379706|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925835|NCT01480076|147379706|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
73925836|NCT01480076|147379706|SUPERIORITY_OR_OTHER|||||||0.0003|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0003
73925837|NCT01480076|147379706|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925838|NCT01480076|147379706|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925839|NCT01480076|147379706|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
73925840|NCT01480076|147379706|SUPERIORITY_OR_OTHER|||||||0.0102|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0102
73925841|NCT01480076|147379706|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
74028948|NCT00117338|147612056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.931||95.0|-0.41|0.45|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.45|-0.41|0.931
74028949|NCT00117338|147612057|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99||||0.975||95.0|0.61|1.61|||Regression, Logistic|Model terms: treatment and baseline FEV1 as covariate||||1.61|0.61|0.975
73925842|NCT01480076|147379706|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925843|NCT01480076|147379706|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
73925844|NCT01480076|147379706|SUPERIORITY_OR_OTHER|||||||0.0012|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0012
73925845|NCT01480076|147379706|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73862314|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.27||||||90.0|-8.13|-0.41|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.41|-8.13|
73925846|NCT01480076|147379706|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925847|NCT01480076|147379706|SUPERIORITY_OR_OTHER|||||||0.0026|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0026
73925848|NCT01480076|147379706|SUPERIORITY_OR_OTHER|||||||0.0161|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0161
73925849|NCT01480076|147379706|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925850|NCT01480076|147379706|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
73925851|NCT01480076|147379706|SUPERIORITY_OR_OTHER|||||||0.1151|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1151
73925852|NCT01480076|147379706|SUPERIORITY_OR_OTHER|||||||0.004|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0040
73968741|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|834.6|||||TWO_SIDED|95.0|496.7|1402.3|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1402.3|496.7|
73925853|NCT01480076|147379707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925854|NCT01480076|147379707|SUPERIORITY_OR_OTHER|||||||0.6769|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6769
73925855|NCT01480076|147379707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
74028950|NCT00117338|147612058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.612||95.0|-0.05|0.09|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.09|-0.05|0.612
73925856|NCT01480076|147379707|SUPERIORITY_OR_OTHER|||||||0.578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5780
73925857|NCT01480076|147379707|SUPERIORITY_OR_OTHER||difference of LS means|3.4|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925858|NCT01480076|147379707|SUPERIORITY_OR_OTHER||difference of LS means|4.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925859|NCT01480076|147379707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925860|NCT01480076|147379707|SUPERIORITY_OR_OTHER|||||||0.8886|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8886
73925861|NCT01480076|147379707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925862|NCT01480076|147379707|SUPERIORITY_OR_OTHER|||||||0.3221|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3221
73925863|NCT01480076|147379707|SUPERIORITY_OR_OTHER||difference of LS means|3.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925864|NCT01480076|147379707|SUPERIORITY_OR_OTHER||difference of LS means|5.3|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925865|NCT01480076|147379707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925866|NCT01480076|147379707|SUPERIORITY_OR_OTHER|||||||0.4668|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4668
73925867|NCT01480076|147379707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925868|NCT01480076|147379707|SUPERIORITY_OR_OTHER|||||||0.5695|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5695
73925869|NCT01480076|147379707|SUPERIORITY_OR_OTHER||difference of LS means|2.4|STANDARD_ERROR_OF_MEAN|0.88||0.0058|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0058
74028951|NCT00117338|147612059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.774||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.08|-0.06|0.774
74028952|NCT00117338|147612060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.173||95.0|-0.02|0.11|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.11|-0.02|0.173
73862315|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||||90.0|-6.01|-1.29|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.29|-6.01|
73862316|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||||90.0|-5.91|1.81|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.81|-5.91|
73862317|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||||90.0|-3.46|1.27|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.27|-3.46|
73925870|NCT01480076|147379707|SUPERIORITY_OR_OTHER||difference of LS means|4.6|STANDARD_ERROR_OF_MEAN|1.4||0.001|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0010
73925871|NCT01480076|147379707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925872|NCT01480076|147379707|SUPERIORITY_OR_OTHER|||||||0.204|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2040
73925873|NCT01480076|147379707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
74028953|NCT00117338|147612061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||ANCOVA|ANCOVA model (Nonparametric) based on Tukey's normalized ranks with terms treatment, region (US, non-US) and baseline FEV1 as covariate||||||0.580
74028954|NCT02385123|147612067|OTHER||||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
73925874|NCT01480076|147379707|SUPERIORITY_OR_OTHER|||||||0.6306|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6306
73925875|NCT01480076|147379707|SUPERIORITY_OR_OTHER||difference of LS means|3.9|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non- responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925876|NCT01480076|147379707|SUPERIORITY_OR_OTHER||difference of LS means|4.7|STANDARD_ERROR_OF_MEAN|1.51||0.002|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0020
73925877|NCT01480076|147379707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
74028955|NCT02385123|147612068|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
73925878|NCT01480076|147379707|SUPERIORITY_OR_OTHER|||||||0.4052|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4052
73925879|NCT01480076|147379707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968742|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|1068.4|||||TWO_SIDED|95.0|683.3|1670.6|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1670.6|683.3|
74028956|NCT02385123|147612069|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
74028957|NCT02385123|147612070|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people|||
74028958|NCT02385123|147612071|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
74028959|NCT02385123|147612072|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
74028960|NCT02385123|147612073|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
74028961|NCT02385123|147612074|OTHER|||||||||||||||||A single group analysis was used to determine this outcome measure.|A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
73925880|NCT01480076|147379707|SUPERIORITY_OR_OTHER|||||||0.8626|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8626
73925881|NCT01480076|147379707|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|0.93||0.0004|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
73925882|NCT01480076|147379707|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|1.49||0.0263|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0263
73968743|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|1933.1|||||TWO_SIDED|95.0|1224.7|3051.1|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3051.1|1224.7|
73925883|NCT01480076|147379708|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925884|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.8999|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8999
73925885|NCT01480076|147379708|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925886|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.7156|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7156
73925887|NCT01480076|147379708|SUPERIORITY_OR_OTHER||difference of LS means|2.9|STANDARD_ERROR_OF_MEAN|1.03||0.005|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0050
73925888|NCT01480076|147379708|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|1.68||0.049|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0490
73925889|NCT01480076|147379708|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968744|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|3163.1|||||TWO_SIDED|95.0|2247.5|4451.7|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||4451.7|2247.5|
73925890|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.274|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2740
73925891|NCT01480076|147379708|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925892|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.5556|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5556
73925893|NCT01480076|147379708|SUPERIORITY_OR_OTHER||difference of LS means|5.2|STANDARD_ERROR_OF_MEAN|1.15|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925894|NCT01480076|147379708|SUPERIORITY_OR_OTHER||difference of LS means|3.7|STANDARD_ERROR_OF_MEAN|1.88||0.0476|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0476
73925895|NCT01480076|147379708|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968745|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|1524.1|||||TWO_SIDED|95.0|913.5|2543.0|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2543.0|913.5|
74028962|NCT02385123|147612075|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
73925896|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.8627|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8627
73968746|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|799.4|||||TWO_SIDED|95.0|532.9|1199.4|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1199.4|532.9|
73968747|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|1469.2|||||TWO_SIDED|95.0|995.3|2168.8|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2168.8|995.3|
73968748|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|549.4|||||TWO_SIDED|95.0|371.8|811.8|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||811.8|371.8|
73968749|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|642.6|||||TWO_SIDED|95.0|309.2|1335.9|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1335.9|309.2|
73968750|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|2630.0|||||TWO_SIDED|95.0|2037.6|3394.6|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3394.6|2037.6|
73968751|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|2.0|||||TWO_SIDED|95.0|1.2|3.4|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3.4|1.2|
73968752|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|1431.2|||||TWO_SIDED|95.0|905.2|2262.9|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2262.9|905.2|
73968753|NCT05093829|147475788|OTHER||Ratio of geometric mean titers|1.7|||||TWO_SIDED|95.0|0.9|3.3|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3.3|0.9|
73968754|NCT06132867|147475807|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90 percent (%) confidence intervals (CIs) were calculated using the exponentiation of the difference between treatment least square means (LSM) from the analyses on the natural log-transformed of Cmax.|Geometric Mean Ratio (GMR) (%)|92.2|||||TWO_SIDED|90.0|86.98|97.74|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||97.74|86.98|
74028963|NCT02385123|147612076|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
73968755|NCT06132867|147475808|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUClast.|GMR (%)|96.0|||||TWO_SIDED|90.0|88.48|104.16|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||104.16|88.48|
74028964|NCT02385123|147612077|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
73925897|NCT01480076|147379708|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925898|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.4312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4312
73925899|NCT01480076|147379708|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|1.27||0.0305|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0305
73925900|NCT01480076|147379708|SUPERIORITY_OR_OTHER||difference of LS means|2.6|STANDARD_ERROR_OF_MEAN|2.03||0.2059|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2059
73925901|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.0008|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0008
73968756|NCT06132867|147475809|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUCinf.|GMR (%)|95.84|||||TWO_SIDED|90.0|88.81|103.42|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||103.42|88.81|
73968757|NCT00667251|147475831|OTHER||Hazard Ratio (HR)|1.367||||0.001|TWO_SIDED|95.0|1.133|1.648|||Log Rank|||PFS at the time of Primary Analysis (IIT population)||1.648|1.133|0.0010
73968758|NCT00667251|147475831|OTHER||Hazard Ratio (HR)|1.484||||0.0002|TWO_SIDED|95.0|1.204|1.829|||Log Rank|||PFS at the time of Primary Analysis (Central HER2+ population)||1.829|1.204|0.0002
73968759|NCT00667251|147475832|OTHER||Hazard Ratio (HR)|1.3722|||||TWO_SIDED|95.0|1.1466|1.6422|||||Stratified HR for LTax/L versus TTax/T|PFS at the time of Final Analysis (IIT population)||1.6422|1.1466|
73968760|NCT00667251|147475832|OTHER||Hazard Ratio (HR)|1.4968|||||TWO_SIDED|95.0|1.2251|1.8288|||||Stratified HR for LTax/L versus TTax/T|PFS at the time of Final Analysis (Central HER2+ population)||1.8288|1.2251|
73968761|NCT00667251|147475833|OTHER||Hazard Ratio (HR)|1.3786|||||TWO_SIDED|95.0|1.0246|1.8549|||||Stratified HR for LTax/L versus TTax/T|Overall Survival (OS) (IIT population)||1.8549|1.0246|
73968762|NCT00667251|147475834|OTHER||Hazard Ratio (HR)|1.5818|||||TWO_SIDED|95.0|1.1181|2.2379|||||Stratified HR for LTax/L versus TTax/T|Overall Survival (OS) (Central HER2+ population)||2.2379|1.1181|
74028965|NCT02385123|147612078|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
74028966|NCT02385123|147612079|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
74028967|NCT02385123|147612080|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
73968763|NCT00667251|147475837|OTHER||Hazard Ratio (HR)|1.0916|||||TWO_SIDED|95.0|0.7271|1.6389|||||Stratified HR for LTax/L versus TTax/T|Time to Central Nervous System (CNS) metastasis (IIT population)||1.6389|0.7271|
73968764|NCT00667251|147475838|OTHER||Hazard Ratio (HR)|1.0951|||||TWO_SIDED|95.0|0.7144|1.6787|||||Stratified HR for LTax/L versus TTax/T|Time to Central Nervous System (CNS) metastasis (Central HER2+ population)||1.6787|0.7144|
73968765|NCT00667251|147475843|OTHER||Hazard Ratio (HR)|1.0091|||||TWO_SIDED|95.0|0.809|1.2586|||||Stratified HR for LTax/L versus TTax/T|Time to Response (TTR) (IIT population)||1.2586|0.8090|
73968766|NCT00667251|147475844|OTHER||Hazard Ratio (HR)|0.9573|||||TWO_SIDED|95.0|0.7544|1.2148|||||Stratified HR for LTax/L versus TTax/T|Time to Response (TTR) (Central HER2+ population)||1.2148|0.7544|
73968767|NCT00667251|147475845|OTHER||Hazard Ratio (HR)|1.4866|||||TWO_SIDED|95.0|1.1479|1.9251|||||Stratified HR for LTax/L versus TTax/T|Duration of Response (DoR) (IIT population)||1.9251|1.1479|
73968768|NCT00667251|147475846|OTHER||Hazard Ratio (HR)|1.5594|||||TWO_SIDED|95.0|1.1767|2.0666|||||Stratified HR for LTax/L versus TTax/T|Duration of Response (DoR) (Central HER2+ population)||2.0666|1.1767|
73968769|NCT02995434|147475865|EQUIVALENCE|As reliable estimates of expected effect size were unknown, the study was powered to detect a medium effect (0.5 SD change), considered a reasonable clinically meaningful impact to obtain 80% power based on a repeated measures analysis of variance (RM ANOVA) with 2-tailed alpha of .05 model.|Mean Difference (Net)|-2.08|||||TWO_SIDED|95.0|-3.86|-0.3|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|Null hypothesis: There is no difference between the reported daily pain experiences of participants during, or after exposure to VR immersive environments, overall and within four different VR immersive environments, compared to the equivalent applications experienced on a 2D computer screen.||-0.30|-3.86|
73925902|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.3685|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3685
73925903|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.0016|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
73925904|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.9862|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9862
73925905|NCT01480076|147379708|SUPERIORITY_OR_OTHER||difference of LS means|0.8|STANDARD_ERROR_OF_MEAN|1.38||0.5561|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5561
73925906|NCT01480076|147379708|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|2.32||0.2281|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2281
73925907|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.0006|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0006
73925908|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.6004|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6004
73925909|NCT01480076|147379708|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925910|NCT01480076|147379708|SUPERIORITY_OR_OTHER|||||||0.904|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9040
73925911|NCT01480076|147379708|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|1.38||0.0401|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0401
73925912|NCT01480076|147379708|SUPERIORITY_OR_OTHER||difference of LS means|4.1|STANDARD_ERROR_OF_MEAN|2.23||0.0651|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0651
73925913|NCT01480076|147379709|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968770|NCT02995434|147475865|EQUIVALENCE|As reliable estimates of expected effect size were unknown, the study was powered to detect a medium effect (0.5 SD change), considered a reasonable clinically meaningful impact to obtain 80% power based on a repeated measures analysis of variance (RM ANOVA) with 2-tailed alpha of .05 model|Mean Difference (Net)|0.53|||||TWO_SIDED|95.0|-1.24|2.37|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||2.37|-1.24|
73925914|NCT01480076|147379709|SUPERIORITY_OR_OTHER|||||||0.454|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4540
73925915|NCT01480076|147379709|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968771|NCT02995434|147475866|EQUIVALENCE|See section for primary outcome.|Mean Difference (Net)|1.08|||||TWO_SIDED|95.0|-1.59|3.95|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||3.95|-1.59|
73968772|NCT02995434|147475866|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|2.16|||||TWO_SIDED|95.0|-0.55|5.08|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.08|-0.55|
73925916|NCT01480076|147379709|SUPERIORITY_OR_OTHER|||||||0.2949|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2949
73968773|NCT02995434|147475866|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-2.64|3.42|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||3.42|-2.64|
73968774|NCT02995434|147475866|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|2.56|||||TWO_SIDED|95.0|-0.08|5.48|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.48|-0.08|
73968775|NCT02995434|147475867|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.37|||||TWO_SIDED|95.0|-0.71|1.5|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.5|-0.71|
73862318|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||||90.0|-6.16|1.56|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.56|-6.16|
73925917|NCT01480076|147379709|SUPERIORITY_OR_OTHER||difference of LS means|-8.1|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925918|NCT01480076|147379709|SUPERIORITY_OR_OTHER||difference of LS means|-9.0|STANDARD_ERROR_OF_MEAN|3.16||0.0046|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0046
73968776|NCT02995434|147475867|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.62|||||TWO_SIDED|95.0|-0.49|1.89|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.89|-0.49|
73968777|NCT02995434|147475867|EQUIVALENCE|See comments in primary outcome|Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-1.19|1.09|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.09|-1.19|
73968778|NCT02995434|147475867|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.33|||||TWO_SIDED|95.0|-0.88|1.57|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.57|-0.88|
73968779|NCT02995434|147475868|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|2.48|||||TWO_SIDED|95.0|0.02|4.7|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||4.70|0.02|
73968780|NCT02995434|147475868|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|2.04|||||TWO_SIDED|95.0|-0.42|4.39|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||4.39|-0.42|
73968781|NCT02995434|147475868|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|3.79|||||TWO_SIDED|95.0|1.02|6.08|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||6.08|1.02|
73968782|NCT02995434|147475868|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|3.18|||||TWO_SIDED|95.0|0.68|5.69|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.69|0.68|
73968783|NCT02995434|147475869|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-2.31|||||TWO_SIDED|95.0|-5.63|0.98|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||0.98|-5.63|
73968784|NCT02995434|147475869|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-7.35|-0.48|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||-0.48|-7.35|
73968785|NCT02995434|147475869|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-0.87|||||TWO_SIDED|95.0|-4.11|2.62|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||2.62|-4.11|
73968786|NCT02995434|147475869|EQUIVALENCE|See comments in primary outcome|Median Difference (Net)|-2.95|||||TWO_SIDED|95.0|-6.1|0.41|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method.|||0.41|-6.10|
73968787|NCT04873401|147475939|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.49||0.928|TWO_SIDED|95.0|0.39|2.79|||Regression, Logistic|||||2.79|0.39|0.928
73968788|NCT04873401|147475940|SUPERIORITY||Median Difference (Final Values)|-0.173|STANDARD_ERROR_OF_MEAN|0.147||0.24|TWO_SIDED|95.0|-0.24|0.115|||Regression, Linear|||||0.115|-0.24|0.240
73968789|NCT04873401|147475941|SUPERIORITY||Slope|0.1171|STANDARD_ERROR_OF_MEAN|0.062||0.367|TWO_SIDED|95.0|0.05|0.29|||Regression, Linear|||||0.29|0.05|0.367
73968790|NCT04873401|147475942|SUPERIORITY||Slope|0.171|STANDARD_ERROR_OF_MEAN|0.062||0.005|TWO_SIDED|95.0|0.05|0.29|||Regression, Linear|||||0.29|0.05|0.005
73968791|NCT05178316|147475946|SUPERIORITY||Least squares mean difference|0.31|STANDARD_ERROR_OF_MEAN|2.175|=|0.8862|TWO_SIDED|95.0|-3.98|4.6|||Mixed Models Analysis|||||4.60|-3.98|=0.8862
73968792|NCT05178316|147475946|SUPERIORITY||Least squares mean difference|-0.74|STANDARD_ERROR_OF_MEAN|1.817|=|0.6832|TWO_SIDED|95.0|-4.32|2.84|||Mixed Models Analysis|||||2.84|-4.32|=0.6832
73925919|NCT01480076|147379709|SUPERIORITY_OR_OTHER||difference of LS means|-12.6|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925920|NCT01480076|147379709|SUPERIORITY_OR_OTHER|||||||0.502|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5020
73925921|NCT01480076|147379709|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925922|NCT01480076|147379709|SUPERIORITY_OR_OTHER|||||||0.2157|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2157
74028968|NCT02385123|147612082|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
73925923|NCT01480076|147379709|SUPERIORITY_OR_OTHER||difference of LS means|-11.2|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925924|NCT01480076|147379709|SUPERIORITY_OR_OTHER||difference of LS means|-10.0|STANDARD_ERROR_OF_MEAN|3.3||0.0026|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0026
73925925|NCT01480076|147379709|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925926|NCT01480076|147379709|SUPERIORITY_OR_OTHER|||||||0.3435|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3435
73925927|NCT01480076|147379709|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968793|NCT05178316|147475947|SUPERIORITY||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.204|=|0.4522|TWO_SIDED|95.0|-0.55|0.25|||Mixed Models Analysis|||||0.25|-0.55|=0.4522
73968794|NCT05178316|147475947|SUPERIORITY||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.169|=|0.2032|TWO_SIDED|95.0|-0.55|0.12|||Mixed Models Analysis|||||0.12|-0.55|=0.2032
73968795|NCT05178316|147475948|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.165|=|0.717|TWO_SIDED|95.0|-0.38|0.26|||Mixed Models Analysis|||||0.26|-0.38|=0.7170
73925928|NCT01480076|147379709|SUPERIORITY_OR_OTHER|||||||0.1357|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1357
73968796|NCT05178316|147475948|SUPERIORITY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.137|=|0.2423|TWO_SIDED|95.0|-0.43|0.11|||Mixed Models Analysis|||||0.11|-0.43|=0.2423
73968797|NCT03457142|147475950|OTHER|No formal test, a confidence interval estimate for the grade 3+ treatment related AE rate.|grade 3+ treatment related AE rate|0.33|||||TWO_SIDED|90.0|0.17|0.54||||||||0.54|0.17|
73968798|NCT01333969|147475962|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.043|TWO_SIDED|95.0|-1.4|-0.02|||GEE|Regression analysis using the generalized estimating equations (GEE) method to compare the changes over time in VAS scores at rest and with exercise||||-0.02|-1.40|.043
73968799|NCT01333969|147475963|OTHER||Mean Difference (Final Values)|0.043||||0.043|TWO_SIDED||||||t-test, 2 sided|||||||.043
73968800|NCT01333969|147475964|SUPERIORITY||Mean Difference (Final Values)|0.584||||0.584|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.584
73968801|NCT01333969|147475965|SUPERIORITY||Mean Difference (Final Values)|0.763||||0.763|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.763
73925929|NCT01480076|147379709|SUPERIORITY_OR_OTHER||difference of LS means|-7.8|STANDARD_ERROR_OF_MEAN|2.22||0.0004|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
73925930|NCT01480076|147379709|SUPERIORITY_OR_OTHER||difference of LS means|-7.0|STANDARD_ERROR_OF_MEAN|3.58||0.0511|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0511
73925931|NCT01480076|147379709|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925932|NCT01480076|147379709|SUPERIORITY_OR_OTHER|||||||0.8703|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8703
73925933|NCT01480076|147379709|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968802|NCT01333969|147475966|SUPERIORITY||Mean Difference (Final Values)|0.602||||0.602|TWO_SIDED||||||GEE|Regression analyses based on the generalized estimating equations (GEE) method||||||.602
73925934|NCT01480076|147379709|SUPERIORITY_OR_OTHER|||||||0.9049|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9049
73968803|NCT01333969|147475967|SUPERIORITY||Mean Difference (Final Values)|0.8656||||0.8656|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.8656
73968804|NCT01333969|147475968|SUPERIORITY||Mean Difference (Final Values)|0.8422||||0.8422|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.8422
73968805|NCT01333969|147475969|SUPERIORITY||Mean Difference (Final Values)|0.526||||0.526|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.526
74028969|NCT02385123|147612083|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
74028970|NCT02385123|147612084|OTHER|Single group analysis.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
73925935|NCT01480076|147379709|SUPERIORITY_OR_OTHER||difference of LS means|-7.6|STANDARD_ERROR_OF_MEAN|2.44||0.0019|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0019
73968806|NCT01333969|147475970|SUPERIORITY||Mean Difference (Final Values)|0.526||||0.526|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.526
73968807|NCT04274764|147476000|OTHER|||||||0.7399|||||||Chi-squared|||||||0.7399
73968808|NCT01926496|147476003|SUPERIORITY||Risk Ratio (RR)|0.89||||0.03|TWO_SIDED|95.0|0.8|0.99|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||0.99|0.80|0.03
73968809|NCT01926496|147476004|SUPERIORITY||Risk Ratio (RR)|0.95||||0.18|TWO_SIDED|95.0|0.87|1.03|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||1.03|0.87|0.18
73968810|NCT01926496|147476005|SUPERIORITY||Risk Ratio (RR)|0.66|||<|0.001|TWO_SIDED|95.0|0.52|0.84|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||0.84|0.52|<0.001
73968811|NCT02677298|147476007|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73968812|NCT02677298|147476008|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary Outcome Measure shows a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||<0.001
73968813|NCT02677298|147476009|SUPERIORITY|||||||0.003||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.003
73925936|NCT01480076|147379709|SUPERIORITY_OR_OTHER||difference of LS means|-12.3|STANDARD_ERROR_OF_MEAN|4.15||0.0033|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0033
73925937|NCT01480076|147379709|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925938|NCT01480076|147379709|SUPERIORITY_OR_OTHER|||||||0.4087|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4087
73925939|NCT01480076|147379709|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925940|NCT01480076|147379709|SUPERIORITY_OR_OTHER|||||||0.2755|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2755
73925941|NCT01480076|147379709|SUPERIORITY_OR_OTHER||difference of LS means|-5.7|STANDARD_ERROR_OF_MEAN|2.52||0.0251|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0251
73925942|NCT01480076|147379709|SUPERIORITY_OR_OTHER||difference of LS means|-6.7|STANDARD_ERROR_OF_MEAN|4.08||0.0989|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0989
73925943|NCT01480076|147379710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925944|NCT01480076|147379710|SUPERIORITY_OR_OTHER|||||||0.8767|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8767
73925945|NCT01480076|147379710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925946|NCT01480076|147379710|SUPERIORITY_OR_OTHER|||||||0.3673|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3673
73968814|NCT02677298|147476010|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Investigator's In-clinic Assessment||||<0.001
73925947|NCT01480076|147379710|SUPERIORITY_OR_OTHER||difference of LS means|-6.8|STANDARD_ERROR_OF_MEAN|1.91||0.0004|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
73968815|NCT02677298|147476010|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Subject's In-clinic Assessment||||<0.001
73968816|NCT02677298|147476011|SUPERIORITY|||||||0.084||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for responders rates at week 20||||0.084
73925948|NCT01480076|147379710|SUPERIORITY_OR_OTHER||difference of LS means|-6.9|STANDARD_ERROR_OF_MEAN|3.12||0.0273|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0273
73925949|NCT01480076|147379710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925950|NCT01480076|147379710|SUPERIORITY_OR_OTHER|||||||0.9091|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9091
73925951|NCT01480076|147379710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925952|NCT01480076|147379710|SUPERIORITY_OR_OTHER|||||||0.7718|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7718
73925953|NCT01480076|147379710|SUPERIORITY_OR_OTHER||difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|2.11|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925954|NCT01480076|147379710|SUPERIORITY_OR_OTHER||difference of LS means|-10.1|STANDARD_ERROR_OF_MEAN|3.5||0.0038|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0038
73925955|NCT01480076|147379710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925956|NCT01480076|147379710|SUPERIORITY_OR_OTHER|||||||0.272|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2720
73925957|NCT01480076|147379710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925958|NCT01480076|147379710|SUPERIORITY_OR_OTHER|||||||0.4767|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4767
73968817|NCT02677298|147476012|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for the Modified Skindex-16 (GL-QoL) Emotional domain change from baseline at week 4||||<0.001
73925959|NCT01480076|147379710|SUPERIORITY_OR_OTHER||difference of LS means|-4.5|STANDARD_ERROR_OF_MEAN|2.32||0.0553|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0553
73968818|NCT02677298|147476012|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||This test was performed for the Modified Skindex-16 (GL-QoL) Functioning domain - Change from baseline at Week 4||||<0.001
74087267|NCT01117766|147728455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.478||0.7506|TWO_SIDED|95.0|-0.83|1.14|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||1.14|-0.83|0.7506
74028971|NCT02385123|147612085|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
74028972|NCT02385123|147612086|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
73862319|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.43||||||90.0|-5.79|-1.06|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.06|-5.79|
73925960|NCT01480076|147379710|SUPERIORITY_OR_OTHER||difference of LS means|-6.9|STANDARD_ERROR_OF_MEAN|3.73||0.0632|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0632
73925961|NCT01480076|147379710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925962|NCT01480076|147379710|SUPERIORITY_OR_OTHER|||||||0.9398|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9398
73925963|NCT01480076|147379710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925964|NCT01480076|147379710|SUPERIORITY_OR_OTHER|||||||0.5655|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5655
73925965|NCT01480076|147379710|SUPERIORITY_OR_OTHER||difference of LS means|-5.9|STANDARD_ERROR_OF_MEAN|2.54||0.0204|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0204
73925966|NCT01480076|147379710|SUPERIORITY_OR_OTHER||difference of LS means|-6.4|STANDARD_ERROR_OF_MEAN|4.37||0.1414|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1414
73925967|NCT01480076|147379710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925968|NCT01480076|147379710|SUPERIORITY_OR_OTHER|||||||0.6279|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6279
73968819|NCT02677298|147476012|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||This test was performed for the Modified Skindex-16 (GL-QoL) Overall score||||<0.001
73968820|NCT02677298|147476012|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test was performed for the FACE-Q Appraisal of Lines Between Eyebrows Scale - Change from Baseline at Week 4||||<0.001
73925969|NCT01480076|147379710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925970|NCT01480076|147379710|SUPERIORITY_OR_OTHER|||||||0.2239|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2239
73925971|NCT01480076|147379710|SUPERIORITY_OR_OTHER||difference of LS means|-7.5|STANDARD_ERROR_OF_MEAN|2.67||0.0049|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0049
73925972|NCT01480076|147379710|SUPERIORITY_OR_OTHER||difference of LS means|-4.1|STANDARD_ERROR_OF_MEAN|4.32||0.3457|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3457
73925973|NCT01480076|147379711|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925974|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.2087|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2087
73925975|NCT01480076|147379711|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925976|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.4487|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4487
73925977|NCT01480076|147379711|SUPERIORITY_OR_OTHER||difference of LS means|-2.1|STANDARD_ERROR_OF_MEAN|0.64||0.0013|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0013
73925978|NCT01480076|147379711|SUPERIORITY_OR_OTHER||difference of LS means|-2.7|STANDARD_ERROR_OF_MEAN|1.15||0.0188|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0188
73925979|NCT01480076|147379711|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
74028973|NCT02385123|147612087|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
73925980|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.4243|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4243
73925981|NCT01480076|147379711|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925982|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.9989|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9989
73925983|NCT01480076|147379711|SUPERIORITY_OR_OTHER||difference of LS means|-1.6|STANDARD_ERROR_OF_MEAN|0.68||0.0207|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0207
73925984|NCT01480076|147379711|SUPERIORITY_OR_OTHER||difference of LS means|-2.9|STANDARD_ERROR_OF_MEAN|1.18||0.0161|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0161
73925985|NCT01480076|147379711|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925986|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.4256|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4256
73925987|NCT01480076|147379711|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73925988|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.3313|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3313
73925989|NCT01480076|147379711|SUPERIORITY_OR_OTHER||difference of LS means|-1.9|STANDARD_ERROR_OF_MEAN|0.83||0.0238|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0238
73925990|NCT01480076|147379711|SUPERIORITY_OR_OTHER||difference of LS means|-3.4|STANDARD_ERROR_OF_MEAN|1.39||0.015|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0150
73925991|NCT01480076|147379711|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
74028974|NCT02385123|147612088|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
74028975|NCT03626415|147612089|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|94.4|||||TWO_SIDED|90.0|62.96|141.55|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||141.55|62.96|
73925992|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.0171|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0171
74028976|NCT03626415|147612089|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adusted Geometric Means|105.53|||||TWO_SIDED|90.0|70.38|158.24|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||158.24|70.38|
73925993|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.0007|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
73925994|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.5146|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5146
73925995|NCT01480076|147379711|SUPERIORITY_OR_OTHER||difference of LS means|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0003|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0003
73925996|NCT01480076|147379711|SUPERIORITY_OR_OTHER||difference of LS means|-2.7|STANDARD_ERROR_OF_MEAN|1.72||0.1224|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1224
74028977|NCT03626415|147612090|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|133.33|||||TWO_SIDED|90.0|86.17|206.28|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||206.28|86.17|
74028978|NCT03626415|147612090|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|153.99|||||TWO_SIDED|90.0|99.52|238.25|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||238.25|99.52|
73925997|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.0168|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0168
73925998|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.2272|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2272
73925999|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.057|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0570
73926000|NCT01480076|147379711|SUPERIORITY_OR_OTHER|||||||0.5832|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5832
73926001|NCT01480076|147379711|SUPERIORITY_OR_OTHER||difference of LS means|-1.8|STANDARD_ERROR_OF_MEAN|0.94||0.0561|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0561
73926002|NCT01480076|147379711|SUPERIORITY_OR_OTHER||difference of LS means|-1.9|STANDARD_ERROR_OF_MEAN|1.86||0.2971|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2971
73926003|NCT01480076|147379712|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926004|NCT01480076|147379712|SUPERIORITY_OR_OTHER|||||||0.0029|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0029
74028979|NCT03626415|147612091|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|75.94|||||TWO_SIDED|90.0|57.39|100.47|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||100.47|57.39|
74028980|NCT03626415|147612091|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|84.14|||||TWO_SIDED|90.0|63.59|111.33|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||111.33|63.59|
74028981|NCT03626415|147612092|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|95.74|||||TWO_SIDED|90.0|72.71|126.08|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||126.08|72.71|
74028982|NCT03626415|147612092|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|114.82|||||TWO_SIDED|90.0|87.19|151.2|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||151.20|87.19|
73926005|NCT01480076|147379712|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968821|NCT02677298|147476012|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test was performed for the FACE-Q Age Appraisal VAS score||||<0.001
73968822|NCT03210272|147476033|OTHER||Geometric Mean Ratio T/R (%)|155.6|||||TWO_SIDED|90.0|130.66|185.3|||||intra-individual gCV (%) = 18.1|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||185.30|130.66|
73968823|NCT03210272|147476033|OTHER||Ratio T/R (%)|240.12|||||TWO_SIDED|90.0|196.25|293.81|||||intra-individual gCV (%) = 27.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||293.81|196.25|
73968824|NCT03210272|147476034|OTHER||Geometric Mean Ratio T/R (%)|156.37|||||TWO_SIDED|90.0|132.73|184.22|||||intra-individual gCV (%) = 17.0|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||184.22|132.73|
73968825|NCT03210272|147476034|OTHER||Ratio T/R (%)|245.56|||||TWO_SIDED|90.0|200.7|300.44|||||intra-individual gCV (%) = 27.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||300.44|200.70|
73968826|NCT03210272|147476035|OTHER||Geometric Mean Ratio T/R (%)|158.74|||||TWO_SIDED|90.0|114.25|220.56|||||intra-individual gCV (%) = 34.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||220.56|114.25|
73968827|NCT03210272|147476035|OTHER||Ratio T/R (%)|246.13|||||TWO_SIDED|90.0|203.37|297.89|||||intra-individual gCV (%) = 26.2|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||297.89|203.37|
73968828|NCT03039023|147476054|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.2||||||A p-value \<0.05 was considered significant.|Wilcoxon signed-rank test|||||||0.20
73968829|NCT03039023|147476054|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
73968830|NCT03039023|147476054|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
73968831|NCT03039023|147476054|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
73968832|NCT03039023|147476054|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.27||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.27
73968833|NCT03039023|147476055|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.1||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.10
73968834|NCT03039023|147476055|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.0002||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.0002
73968835|NCT03039023|147476055|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.01||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.01
73968836|NCT03039023|147476055|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.006||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.006
73968837|NCT03039023|147476055|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.79||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.79
73968838|NCT03039023|147476056|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.28||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.28
73968839|NCT03039023|147476056|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
73968840|NCT03039023|147476056|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
73968841|NCT03039023|147476056|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
73968842|NCT03039023|147476056|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.11||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.11
73968843|NCT03039023|147476057|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.005||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.005
73968844|NCT03039023|147476057|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.001
73968845|NCT03039023|147476057|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.001
73968846|NCT03039023|147476057|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.009||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.009
73968847|NCT03039023|147476057|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.04||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.04
73968848|NCT03039023|147476058|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.93||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.93
73926006|NCT01480076|147379712|SUPERIORITY_OR_OTHER|||||||0.8041|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8041
73926007|NCT01480076|147379712|SUPERIORITY_OR_OTHER||difference of LS means|11.8|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926008|NCT01480076|147379712|SUPERIORITY_OR_OTHER||difference of LS means|9.4|STANDARD_ERROR_OF_MEAN|3.1||0.0026|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0026
73926009|NCT01480076|147379712|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926010|NCT01480076|147379712|SUPERIORITY_OR_OTHER|||||||0.0689|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0689
73968849|NCT03039023|147476058|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.01||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.01
74028983|NCT02345434|147612122|SUPERIORITY||Mean Difference (Final Values)|3.53|||||TWO_SIDED|95.0|-6.35|13.4||||||||13.4|-6.35|
74028984|NCT02345434|147612123|SUPERIORITY||Mean Difference (Final Values)|-0.79|||||TWO_SIDED|95.0|-3.68|2.1||||||||2.1|-3.68|
74087268|NCT01117766|147728455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.299||0.9673|TWO_SIDED|95.0|-0.61|0.64|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.64|-0.61|0.9673
73926011|NCT01480076|147379712|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926012|NCT01480076|147379712|SUPERIORITY_OR_OTHER|||||||0.7182|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7182
73926013|NCT01480076|147379712|SUPERIORITY_OR_OTHER||difference of LS means|11.6|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968850|NCT03039023|147476058|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.003||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.003
73968851|NCT03039023|147476058|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.04||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.04
73968852|NCT03039023|147476058|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.99||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.99
73968853|NCT03039023|147476059|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.02||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.02
74028985|NCT02926573|147612127|SUPERIORITY||Median Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.27|0.94||||||||0.94|-0.27|
74028986|NCT02926573|147612128|SUPERIORITY||Percent Difference|9.2|||||TWO_SIDED|95.0|-3.0|21.0||||||||21|-3.0|
74028987|NCT02926573|147612130|SUPERIORITY||Percent Difference|-2.0|||||TWO_SIDED|95.0|-15.0|11.0|||||"The estimation parameter is based on those participants who answered they were very satisfied with overall pain control."|||11|-15|
74028988|NCT02926573|147612131|SUPERIORITY||Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-3.4|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||18.3|-3.4|
74028989|NCT02926573|147612131|SUPERIORITY||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|-2.9|20.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||20.3|-2.9|
74028990|NCT02926573|147612131|SUPERIORITY||Mean Difference (Final Values)|7.2|||||TWO_SIDED|95.0|-4.6|18.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||18.9|-4.6|
74087269|NCT01117766|147728456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.642||0.5502|TWO_SIDED|95.0|-0.99|1.78|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||1.78|-0.99|0.5502
73926014|NCT01480076|147379712|SUPERIORITY_OR_OTHER||difference of LS means|9.8|STANDARD_ERROR_OF_MEAN|3.57||0.0061|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0061
73926015|NCT01480076|147379712|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926016|NCT01480076|147379712|SUPERIORITY_OR_OTHER|||||||0.0179|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0179
73926017|NCT01480076|147379712|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926018|NCT01480076|147379712|SUPERIORITY_OR_OTHER|||||||0.6911|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6911
73926019|NCT01480076|147379712|SUPERIORITY_OR_OTHER||difference of LS means|10.8|STANDARD_ERROR_OF_MEAN|2.31|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926020|NCT01480076|147379712|SUPERIORITY_OR_OTHER||difference of LS means|7.1|STANDARD_ERROR_OF_MEAN|3.85||0.0666|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0666
73926021|NCT01480076|147379712|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926022|NCT01480076|147379712|SUPERIORITY_OR_OTHER|||||||0.0158|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0158
74028991|NCT02926573|147612131|SUPERIORITY||Mean Difference (Final Values)|5.1|||||TWO_SIDED|95.0|-6.6|16.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|||16.8|-6.6|
74028992|NCT02926573|147612131|SUPERIORITY||Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-3.6|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||18.3|-3.6|
74028993|NCT02926573|147612131|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-5.6|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||21.6|-5.6|
73926023|NCT01480076|147379712|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73968854|NCT03039023|147476059|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
73968855|NCT03039023|147476059|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
73968856|NCT03039023|147476059|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.001
73968857|NCT03039023|147476059|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.02||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.02
73968858|NCT03064217|147476089|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73968859|NCT05516147|147476090|SUPERIORITY||||||<|0.01||||||A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.|t-test, 2 sided|||A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.||||<.01
73968860|NCT05516147|147476091|SUPERIORITY||||||<|0.01||||||A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.|t-test, 2 sided|A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.||A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.||||<.01
73968861|NCT05516147|147476092|SUPERIORITY|||||||0.06||||||A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.|t-test, 2 sided|A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.||A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.||||0.06
74028994|NCT02926573|147612131|SUPERIORITY||Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|-3.5|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||23.8|-3.5|
73926024|NCT01480076|147379712|SUPERIORITY_OR_OTHER|||||||0.6684|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6684
73926025|NCT01480076|147379712|SUPERIORITY_OR_OTHER||difference of LS means|11.6|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926026|NCT01480076|147379712|SUPERIORITY_OR_OTHER||difference of LS means|10.5|STANDARD_ERROR_OF_MEAN|4.28||0.0141|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0141
73926027|NCT01480076|147379712|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926028|NCT01480076|147379712|SUPERIORITY_OR_OTHER|||||||0.0042|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0042
73926029|NCT01480076|147379712|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926030|NCT01480076|147379712|SUPERIORITY_OR_OTHER|||||||0.7329|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7329
73926031|NCT01480076|147379712|SUPERIORITY_OR_OTHER||difference of LS means|13.2|STANDARD_ERROR_OF_MEAN|2.65|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926032|NCT01480076|147379712|SUPERIORITY_OR_OTHER||difference of LS means|10.1|STANDARD_ERROR_OF_MEAN|4.49||0.0242|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0242
73968862|NCT05516147|147476093|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||A one-sample t-test was used to assess whether the mean was different from a known Non Engagement mean of 0.40 for standard programming.||||<.01
74028995|NCT02926573|147612132|SUPERIORITY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-0.9|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||22.3|-0.9|
73968863|NCT05516147|147476095|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||baseline score vs. post-treatment, paired sample t-test||||0.81
73968864|NCT05516147|147476096|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.20
73968865|NCT05516147|147476097|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.83
74028996|NCT02926573|147612132|SUPERIORITY||Mean Difference (Final Values)|9.1|||||TWO_SIDED|95.0|-3.4|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||21.6|-3.4|
73968866|NCT05516147|147476098|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.320
73968867|NCT05908344|147476157|OTHER|Effect size determination|Cohen's d|-0.24|||||TWO_SIDED|||||||||Comparison for NREM1 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design||||
73968868|NCT05908344|147476157|OTHER|Effect size determination|Cohen's d|-0.15|||||TWO_SIDED|||||||||Comparison for NREM2 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
73968869|NCT05908344|147476157|OTHER|Effect size determination|Cohen's d|0.69|||||TWO_SIDED|||||||||Comparison for NREM3 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
73968870|NCT05908344|147476157|OTHER|Effect size determination|Cohen's d|-0.82|||||TWO_SIDED|||||||||Comparison for REM minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
73968871|NCT05908344|147476158|OTHER|Effect size determination|Cohen's d|-0.04|||||TWO_SIDED|||||||||Comparison for NREM1 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
73968872|NCT05908344|147476158|OTHER|Effect size determination|Cohen's d|0.24|||||TWO_SIDED|||||||||Comparison for NREM2 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
73968873|NCT05908344|147476158|OTHER|Effect size determination|Cohen's d|0.8|||||TWO_SIDED|||||||||Comparison for NREM3 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
74028997|NCT02926573|147612132|SUPERIORITY||Mean Difference (Final Values)|6.3|||||TWO_SIDED|95.0|-6.1|18.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||18.6|-6.1|
74087270|NCT01117766|147728456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.5||0.8536|TWO_SIDED|95.0|-1.15|0.96|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.96|-1.15|0.8536
74028998|NCT02926573|147612132|SUPERIORITY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-7.3|17.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|||17.8|-7.3|
73968874|NCT05908344|147476158|OTHER|Effect size determination|Cohen's d|-0.78|||||TWO_SIDED|||||||||Comparison for REM percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
73968875|NCT05908344|147476159|OTHER|Effect size determination|Cohen's d|0.11|||||TWO_SIDED|||||||||Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
73968876|NCT05546749|147476172|SUPERIORITY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.93||0.17|TWO_SIDED|95.0|-3.1|0.54|||Mixed Models Analysis|||A mixed effects model was performed to predict pain intensity by arm at weeks 3 and 6, controlling for baseline pain intensity score.||0.54|-3.1|0.17
73968877|NCT05546749|147476173|SUPERIORITY||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|13.6||0.32|TWO_SIDED|95.0|-40.3|13.1|||Mixed Models Analysis|||A mixed effects model was used to predict opioid craving score by arm at weeks 3 and 6, controlling for baseline opioid craving score.||13.1|-40.3|0.32
73968878|NCT05546749|147476182|SUPERIORITY||Mean Difference (Final Values)|-9.7|STANDARD_ERROR_OF_MEAN|6.1||0.137|TWO_SIDED|95.0|-23.1|3.6|||Regression, Linear||RelieVRx was associated with lower stress score.|We performed a mixed effects model to predict stress score at week 6 by arm, controlling for baseline stress score.||3.6|-23.1|0.137
73968879|NCT03652688|147476232|SUPERIORITY||F|14.463|||<|0.001|TWO_SIDED||||||ANOVA|||The unit of analyses was the individual, nested within groups.||||<0.001
73968880|NCT03652688|147476233|SUPERIORITY|||||||0.08|||||||Chi-squared, Corrected|||||||.08
73968881|NCT03652688|147476234|SUPERIORITY|||||||0.954|||||||Chi-squared, Corrected|||||||0.954
73968882|NCT03652688|147476235|SUPERIORITY||Chi-Square|4.436||||0.035|TWO_SIDED||||||Chi-squared, Corrected|||||||.035
73968883|NCT03652688|147476236|SUPERIORITY||Chi-Square|2.615||||0.106|TWO_SIDED||||||Chi-squared, Corrected|||||||.106
73968884|NCT03652688|147476237|SUPERIORITY||Chi-Square|11.636|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
73968885|NCT05746494|147476317|OTHER|Omnibus analysis||||||0.023|||||||ANOVA|||||||0.023
73968886|NCT05746494|147476318|OTHER|Omnibus analysis||||||0.042|||||||Multilevel Modeling|||||||0.042
73968887|NCT05746494|147476319|OTHER|Omnibus analysis||||||0.98|||||||t-test, 2 sided|||||||0.980
73968888|NCT05746494|147476320|OTHER|Omnibus analysis||||||0.01|||||||Multilevel Modeling|||||||0.010
73968889|NCT05746494|147476321|OTHER|Omnibus analysis||||||0.064|||||||t-test, 2 sided|||||||0.064
73968890|NCT05746494|147476322|OTHER|Omnibus analysis||||||0.306|||||||t-test, 2 sided|||||||0.306
73968891|NCT05746494|147476323|OTHER|Omnibus analysis||||||0.041|||||||t-test, 2 sided|||||||0.041
73968892|NCT05746494|147476324|OTHER|Omnibus analysis||||||0.019|||||||t-test, 2 sided|||||||0.019
73968893|NCT03736720|147476325|OTHER|No statistical test.|Proportion|0.091|||||TWO_SIDED|80.0|0.033|0.301|||||Estimated using Jeffrey's prior method.|||0.301|0.033|
73968894|NCT03736720|147476331|SUPERIORITY|||||||0.289|||||||Sign test|two-sided test.||Comparing the pre-treatment and end of treatment QoL scores.||||0.289
73968895|NCT05409183|147476333|OTHER||LS Mean of Treatment Difference|26.473|STANDARD_ERROR_OF_MEAN|9.216||0.0032|TWO_SIDED|95.0|7.847|45.099|||ANCOVA|||||45.099|7.847|0.0032
73968896|NCT03194217|147476336|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.7||0.668|TWO_SIDED|95.0|-1.68|1.08|||ANCOVA|||||1.08|-1.68|0.668
73968897|NCT03194217|147476336|SUPERIORITY||Mean Difference (Final Values)|0.88|STANDARD_ERROR_OF_MEAN|0.7||0.213|TWO_SIDED|95.0|-0.5|2.26|||ANCOVA|||||2.26|-0.50|0.213
74028999|NCT02926573|147612132|SUPERIORITY||Mean Difference (Final Values)|11.2|||||TWO_SIDED|95.0|-1.4|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||23.8|-1.4|
74029000|NCT02926573|147612132|SUPERIORITY||Mean Difference (Final Values)|14.9|||||TWO_SIDED|95.0|-0.1|29.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||29.9|-0.1|
74029001|NCT02926573|147612132|SUPERIORITY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|-2.8|26.0|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||26.0|-2.8|
74087271|NCT01117766|147728457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|0.586||0.0132|TWO_SIDED|95.0|-2.73|-0.34|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.|Week 3 (Visits 3 and 6)||-0.34|-2.73|0.0132
73968898|NCT03194217|147476336|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.7||0.575|TWO_SIDED|95.0|-1.76|0.98|||ANCOVA|||||0.98|-1.76|0.575
73968899|NCT04489771|147476346|SUPERIORITY|P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC risk categories (favorable vs. intermediate or poor).|Difference in Percentage|-0.5||||0.5312|TWO_SIDED|95.0|-14.0|12.9||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen||Belzutifan 200 mg minus Belzutifan 120 mg|||12.9|-14.0|0.5312
73968900|NCT04489771|147476347|OTHER||Hazard Ratio (HR)|0.94||||0.3861|TWO_SIDED|95.0|0.63|1.4||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Log Rank|One-sided nominal p-value based on log-rank test stratified by IMDC risk group (favorable vs. intermediate or poor).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate or poor).|||1.40|0.63|0.3861
73968901|NCT04489771|147476349|OTHER|One-sided nominal p-value, difference in percentage and associated 95% CIs were based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate or poor).|Miettinen & Nurminen method|-6.3||||0.7832|TWO_SIDED|95.0|-21.7|9.4|||Miettinen & Nurminen method|||||9.4|-21.7|0.7832
73968902|NCT04489771|147476350|OTHER||Hazard Ratio (HR)|1.11||||0.6448|TWO_SIDED|95.0|0.65|1.9||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Log Rank|One-sided nominal p-value based on log-rank test stratified by IMDC risk group (favorable vs. intermediate or poor).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate or poor).|||1.90|0.65|0.6448
74029002|NCT02926573|147612133|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-14.7|11.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||11.9|-14.7|
73926033|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
73926034|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.9151|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9151
74029003|NCT02926573|147612133|SUPERIORITY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-8.6|19.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||19.2|-8.6|
73862320|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||||90.0|-7.33|0.39|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.39|-7.33|
73968903|NCT03241459|147476357|NON_INFERIORITY|15.0% is the absolute noninferiority margin (50% of the difference in primary patency rate between IN.PACT Admiral DCB and PTA).|Difference in percentage|-3.7||||0.0029|ONE_SIDED|97.5|-11.7|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.|Farrington-Manning test||For subjects missing primary effectiveness endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.|The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to efficacy endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.|||-11.7|0.0029
73968904|NCT03241459|147476358|NON_INFERIORITY|10.0% is the absolute noninferiority margin (50% of the difference in primary safety endpoint rate between IN.PACT Admiral DCB and PTA).|Difference in percentage|2.0|||<|0.0001|ONE_SIDED|97.5|-4.1|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 10% and a one-sided significance level of 0.025.|Farrington-Manning test||For subjects missing primary safety endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.|The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to safety endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.|||-4.1|<.0001
73968905|NCT03241459|147476359|SUPERIORITY|||||||0.579|TWO_SIDED|95.0||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||The incidence estimates will be reported along with a p-value from a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||0.579
73968906|NCT03241459|147476360|SUPERIORITY|||||||1||||||Both arms demonstrated 100% success, therefore, Fisher's exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||1.00
73968907|NCT03241459|147476361|SUPERIORITY|||||||1||||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||1.000
73968908|NCT03241459|147476362|SUPERIORITY|||||||0.494||||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||||||0.494
74029004|NCT02926573|147612133|SUPERIORITY||Mean Difference (Final Values)|10.9|||||TWO_SIDED|95.0|-2.4|24.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||24.2|-2.4|
74029005|NCT02926573|147612133|SUPERIORITY||Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-6.6|20.7|||||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|20.7|-6.6|
74029006|NCT02926573|147612133|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-6.4|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||22.3|-6.4|
73926035|NCT01480076|147379713|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926036|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.6128|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6128
73926037|NCT01480076|147379713|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0331|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0331
73926038|NCT01480076|147379713|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1919|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1919
73926039|NCT01480076|147379713|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926040|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.4481|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4481
73926041|NCT01480076|147379713|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926042|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.5454|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5454
73926043|NCT01480076|147379713|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0516|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0516
73926044|NCT01480076|147379713|SUPERIORITY_OR_OTHER||difference of LS means|0.09|STANDARD_ERROR_OF_MEAN|0.04||0.0175|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0175
73926045|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
73968909|NCT03241459|147476363|NON_INFERIORITY|The Farrington and Manning test for noninferiority of proportions at a one-sided significance level of 0.025.|Difference in percentage|-1.9||||0.0059|ONE_SIDED|97.5|-12.1|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.|Farrington-Manning test|||The objective is to assess whether the primary patency rate of subjects in the SurVeil DCB group is noninferior to that of the IN.PACT Admiral DCB group:|||-12.1|0.0059
73926046|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.9371|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9371
73968910|NCT03241459|147476364|SUPERIORITY|Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 12 months.||||||0.699||||||12-Month P-Value|Fisher Exact|||The main analysis of the secondary endpoints will be carried out using the ITT analysis set.||||0.699
73926047|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0056
73926048|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.5475|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5475
73926049|NCT01480076|147379713|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0699|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0699
73926050|NCT01480076|147379713|SUPERIORITY_OR_OTHER||difference of LS means|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.587|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5870
73926051|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.0245|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0245
73926052|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.9926|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9926
73926053|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
73926054|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.6368|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6368
73926055|NCT01480076|147379713|SUPERIORITY_OR_OTHER||difference of LS means|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3358|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3358
73968911|NCT03241459|147476364|SUPERIORITY|Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 24 months.||||||1||||||24-Month P-Value|Fisher Exact|||The main analysis of the secondary endpoints will be carried out using the ITT analysis set.||||1.0
73968912|NCT03241459|147476365|SUPERIORITY|||||||0.699|TWO_SIDED|95.0||||6-Month P-Value|Fisher Exact|||||||0.699
73968913|NCT03241459|147476365|SUPERIORITY|||||||0.447||||||12-Month P-Value|Fisher Exact|||||||0.447
73862321|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.26||||||90.0|-5.62|-0.9|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.90|-5.62|
73968914|NCT03241459|147476365|SUPERIORITY|||||||0.589||||||24-Month P-Value|Fisher Exact|||||||0.589
73968915|NCT03241459|147476366|SUPERIORITY|||||||1||||||P-Value at 6-Months|Fisher Exact|||||||1.0
73968916|NCT03241459|147476366|SUPERIORITY|||||||0.823||||||P-Value at 12-Months|Fisher Exact|||||||0.823
73968917|NCT03241459|147476366|SUPERIORITY|||||||0.454||||||P-Value at 24-Months|Fisher Exact|||||||0.454
73968918|NCT03241459|147476367|SUPERIORITY|||||||0.535||||||P-Value at 6-Months|Fisher Exact|||||||0.535
73968919|NCT03241459|147476367|SUPERIORITY|||||||0.86||||||P-Value at 12-Months|Fisher Exact|||||||0.860
73968920|NCT03241459|147476367|SUPERIORITY|||||||0.39||||||P-Value at 24-Months|Fisher Exact|||||||0.390
73968921|NCT03241459|147476368|SUPERIORITY|||||||1||||||Both arms demonstrated 0 amputations at 6 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||||||1.00
73968922|NCT03241459|147476368|SUPERIORITY|||||||1||||||Both arms demonstrated 0 amputations at 12 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||||||1.00
73968923|NCT03241459|147476368|SUPERIORITY|||||||1||||||P-Value at 24-Months|Fisher Exact|||||||1.0
73926056|NCT01480076|147379713|SUPERIORITY_OR_OTHER||difference of LS means|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.5089|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5089
73926057|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.0141|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0141
73926058|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.428|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4280
73926059|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
73926060|NCT01480076|147379713|SUPERIORITY_OR_OTHER|||||||0.3827|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3827
73926061|NCT01480076|147379713|SUPERIORITY_OR_OTHER||difference of LS means|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0748|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0748
73926062|NCT01480076|147379713|SUPERIORITY_OR_OTHER||least squares mean|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.5663|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5663
73926063|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.1544|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1544
73926064|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.0167|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0167
73926065|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.3868|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3868
73862322|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||||90.0|-4.13|3.59|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||3.59|-4.13|
73926066|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.2214|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2214
73968924|NCT03241459|147476369|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73968925|NCT03241459|147476369|SUPERIORITY|||||||0.472||||||P-Value at 24-Months|Fisher Exact|||||||0.472
73968926|NCT03241459|147476370|SUPERIORITY|||||||0.193||||||P-Value for change in Rutherford Classification from BL to 1-Month|Wilcoxon (Mann-Whitney)|||||||0.193
73968927|NCT03241459|147476370|SUPERIORITY|||||||0.14||||||P-Value for change in Rutherford Classification from BL to 6-Months|Wilcoxon (Mann-Whitney)|||||||0.140
73968928|NCT03241459|147476370|SUPERIORITY|||||||0.372||||||P-Value for change in Rutherford Classification from BL to 12-Months|Wilcoxon (Mann-Whitney)|||||||0.372
73968929|NCT03241459|147476370|SUPERIORITY|||||||0.104||||||P-Value for change in Rutherford Classification from BL to 24-Months|Wilcoxon (Mann-Whitney)|||||||0.104
73968930|NCT03241459|147476371|SUPERIORITY|||||||0.32||||||P-Value for change in PARC from BL to 1-Month|Wilcoxon (Mann-Whitney)|||||||0.320
74087272|NCT01117766|147728457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.467||0.0403|TWO_SIDED|95.0|-1.95|-0.05|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.|Week 4 (Visits 4 and 7)||-0.05|-1.95|0.0403
73926067|NCT01480076|147379714|SUPERIORITY_OR_OTHER||difference of LS means|8.9|STANDARD_ERROR_OF_MEAN|4.96||0.0743|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0743
73926068|NCT01480076|147379714|SUPERIORITY_OR_OTHER||difference of LS means|-17.2|STANDARD_ERROR_OF_MEAN|12.22||0.1601|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1601
73926069|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.1251|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1251
73926070|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.1764|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1764
73926071|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.5528|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5528
73926072|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.108|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1080
73926073|NCT01480076|147379714|SUPERIORITY_OR_OTHER||difference of LS means|4.6|STANDARD_ERROR_OF_MEAN|6.27||0.4644|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4644
73926074|NCT01480076|147379714|SUPERIORITY_OR_OTHER||difference of LS means|-30.6|STANDARD_ERROR_OF_MEAN|17.91||0.0887|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0887
73926075|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.0071|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0071
73968931|NCT03241459|147476371|SUPERIORITY|||||||0.132||||||P-Value for change in PARC from BL to 6-Months|Wilcoxon (Mann-Whitney)|||||||0.132
73968932|NCT03241459|147476371|SUPERIORITY|||||||0.248||||||P-Value for change in PARC from BL to 12-Months|Wilcoxon (Mann-Whitney)|||||||0.248
73968933|NCT03241459|147476371|SUPERIORITY|||||||0.194||||||P-Value for change in PARC from BL to 24-Months|Wilcoxon (Mann-Whitney)|||||||0.194
73968934|NCT03241459|147476372|SUPERIORITY|||||||0.789||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 6-Months|Fisher Exact|||||||0.789
73968935|NCT03241459|147476372|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73968936|NCT03241459|147476372|SUPERIORITY|||||||0.041||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 12-Months.|Fisher Exact|||||||0.041
73968937|NCT03241459|147476372|SUPERIORITY|||||||1||||||P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 12-Months.|Fisher Exact|||||||1.0
73968938|NCT03241459|147476372|SUPERIORITY|||||||0.401||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 24-Months.|Fisher Exact|||||||0.401
73968939|NCT03241459|147476372|SUPERIORITY|||||||1||||||P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 24-Months.|Fisher Exact|||||||1.0
73968940|NCT03241459|147476373|OTHER|||||||0.995||||||P-value for change in WIQ from BL to 1-Month: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.995
73968941|NCT03241459|147476373|SUPERIORITY|||||||0.158||||||P-value for change in WIQ from BL to 1-month: Walking distance score|Wilcoxon (Mann-Whitney)|||||||0.158
73968942|NCT03241459|147476373|SUPERIORITY|||||||0.695||||||P-value for change in WIQ from BL to 1-month: Walking speed score|Wilcoxon (Mann-Whitney)|||||||0.695
74087273|NCT01117766|147728458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.433||0.6631|TWO_SIDED|95.0|-1.12|0.74|||ANCOVA|||Week 3 (Visits 3 and 6)||0.74|-1.12|0.6631
74087274|NCT01117766|147728458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|0.465||0.0022|TWO_SIDED|95.0|-2.48|-0.59|||ANCOVA|||Week 4 (Visits 4 and 7)||-0.59|-2.48|0.0022
73862323|NCT00853840|147270498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26||||||90.0|-4.62|0.1|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.10|-4.62|
73926076|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.064|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0640
73926077|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.1552|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1552
73926078|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.5979|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5979
73926079|NCT01480076|147379714|SUPERIORITY_OR_OTHER||difference of LS means|4.3|STANDARD_ERROR_OF_MEAN|5.58||0.4444|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4444
73926080|NCT01480076|147379714|SUPERIORITY_OR_OTHER||difference of LS means|-10.7|STANDARD_ERROR_OF_MEAN|12.27||0.3863|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3863
73968943|NCT03241459|147476373|SUPERIORITY|||||||0.086||||||P-value for change in WIQ from BL to 1-Month: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.086
74029007|NCT02926573|147612133|SUPERIORITY||Mean Difference (Final Values)|15.7|||||TWO_SIDED|95.0|-0.4|31.7|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||31.7|-0.4|
73862324|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.95||||||90.0|4.18|9.72|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||9.72|4.18|
73926081|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.6352|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6352
73926082|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.1265|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1265
73926083|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.6161|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6161
73968944|NCT03241459|147476373|SUPERIORITY|||||||0.331||||||P-value for change in WIQ from BL to 12-Months: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.331
73968945|NCT03241459|147476373|SUPERIORITY|||||||0.58||||||P-value for change in WIQ from BL to 12-Months: Walking Distance Score|Wilcoxon (Mann-Whitney)|||||||0.580
73926084|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.528|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5280
73968946|NCT03241459|147476373|SUPERIORITY|||||||0.563||||||P-value for change in WIQ from BL to 12-Months: Walking Speed Score|Wilcoxon (Mann-Whitney)|||||||0.563
73968947|NCT03241459|147476373|SUPERIORITY|||||||0.27||||||P-value for change in WIQ from BL to 12-Months: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.270
73968948|NCT03241459|147476373|SUPERIORITY|||||||0.869||||||P-value for change in WIQ from BL to 24-Months: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.869
73968949|NCT03241459|147476373|SUPERIORITY|||||||0.837||||||P-value for change in WIQ from BL to 24-Months: Walking Distance Score|Wilcoxon (Mann-Whitney)|||||||0.837
74029008|NCT02926573|147612133|SUPERIORITY||Mean Difference (Final Values)|16.7|||||TWO_SIDED|95.0|0.0|33.4|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||33.4|0.0|
74029009|NCT00858702|147612135|SUPERIORITY_OR_OTHER|||||||0.0158||95.0||||No consideration for multiplicity|Fisher Exact|||||||0.0158
73862325|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.51||||||90.0|2.73|8.28|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||8.28|2.73|
73926085|NCT01480076|147379714|SUPERIORITY_OR_OTHER||difference of LS means|11.5|STANDARD_ERROR_OF_MEAN|8.51||0.1769|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1769
73926086|NCT01480076|147379714|SUPERIORITY_OR_OTHER||difference of LS means|-16.0|STANDARD_ERROR_OF_MEAN|22.24||0.4743|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4743
73926087|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.6901|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6901
73926088|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.0245|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0245
73926089|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.7707|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7707
73926090|NCT01480076|147379714|SUPERIORITY_OR_OTHER|||||||0.4989|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4989
73968950|NCT03241459|147476373|SUPERIORITY|||||||0.674||||||P-value for change in WIQ for BL to 24-Months: Walking Speed Score|Wilcoxon (Mann-Whitney)|||||||0.674
73968951|NCT03241459|147476373|SUPERIORITY|||||||0.563||||||P-value for change in WIQ for BL to 24-Months: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.563
73968952|NCT03241459|147476374|SUPERIORITY|||||||0.237||||||P-value for change in 6MWT from BL to 12-Months|t-test, 2 sided|||||||0.237
73968953|NCT03241459|147476374|SUPERIORITY|||||||0.04||||||P-value for change in 6MWT from BL to 24-Months|t-test, 2 sided|||||||0.040
73968954|NCT03241459|147476375|SUPERIORITY|||||||0.772||||||P-value for change in PAQ from BL to 1-Month: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.772
73968955|NCT03241459|147476375|SUPERIORITY|||||||0.93||||||P-value for change in PAQ from BL to 1-Month: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.930
74029010|NCT00858702|147612136|SUPERIORITY_OR_OTHER|||||||0.0566||95.0||||No consideration for multiplicity|Fisher Exact|||||||0.0566
73968956|NCT03241459|147476375|SUPERIORITY|||||||0.546||||||P-value for change in PAQ from BL to 1-Month: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.546
73968957|NCT03241459|147476375|SUPERIORITY|||||||0.621||||||P-value for change in PAQ from BL to 1-Month: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.621
73926091|NCT01480076|147379714|SUPERIORITY_OR_OTHER||difference of LS means|15.2|STANDARD_ERROR_OF_MEAN|7.31||0.0387|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0387
73968958|NCT03241459|147476375|SUPERIORITY|||||||0.133||||||P-value for change in PAQ from BL to 1-Month: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.133
73968959|NCT03241459|147476375|SUPERIORITY|||||||0.592||||||P-value for change in PAQ from BL to 1-Month: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.592
73968960|NCT03241459|147476375|SUPERIORITY|||||||0.601||||||P-value for change in PAQ from BL to 1-Month: Summary Score|Wilcoxon (Mann-Whitney)|||||||0.601
73968961|NCT03241459|147476375|SUPERIORITY|||||||0.185||||||P-value for change in PAQ from BL to 12-Months: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.185
73968962|NCT03241459|147476375|SUPERIORITY|||||||0.856||||||P-value for change in PAQ from BL to 12-Months: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.856
73968963|NCT03241459|147476375|SUPERIORITY|||||||0.541||||||P-value for change in PAQ from BL to 12-Months: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.541
73968964|NCT03241459|147476375|SUPERIORITY|||||||0.731||||||P-value for change in PAQ from BL to 12-Months: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.731
73968965|NCT03241459|147476375|SUPERIORITY|||||||0.696||||||P-value for change in PAQ from BL to 12-Months: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.696
74029011|NCT00858702|147612137|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No consideration for multiplicity|Fisher Exact|||||||<0.001
74029012|NCT02544984|147612146|SUPERIORITY|||||||0.473|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||The numbers of unscheduled clinic visits due to respiratory symptoms are compared.||||0.473
73968966|NCT03241459|147476375|SUPERIORITY|||||||0.716||||||P-value for change in PAQ from BL to 12-Months: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.716
73968967|NCT03241459|147476375|SUPERIORITY|||||||0.797||||||P-value for change in PAQ from BL to 12-Months: Summary Score|Wilcoxon (Mann-Whitney)|||||||0.797
73968968|NCT03241459|147476375|SUPERIORITY|||||||0.29||||||P-value for change in PAQ from BL to 24-Months: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.290
73968969|NCT03241459|147476375|SUPERIORITY|||||||0.473||||||P-value for change in PAQ from BL to 24-Months: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.473
73968970|NCT03241459|147476375|SUPERIORITY|||||||0.278||||||P-value for change in PAQ from BL to 24-Months: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.278
73968971|NCT03241459|147476375|SUPERIORITY|||||||0.974||||||P-value for change in PAQ from BL to 24-Months: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.974
74029013|NCT02544984|147612146|SUPERIORITY|||||||0.505|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Unscheduled clinic visits due to symptoms other than respiratory symptoms are compared||||0.505
74029014|NCT02544984|147612146|SUPERIORITY|||||||0.047|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of emergency room visits are compared||||0.047
74029015|NCT02544984|147612146|SUPERIORITY|||||||0.675|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of hospital admissions are compared||||0.675
73862326|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.64||||||90.0|0.87|6.42|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.42|0.87|
73968972|NCT03241459|147476375|SUPERIORITY|||||||0.266||||||P-value for change in PAQ from BL to 24-Months: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.266
73968973|NCT03241459|147476375|SUPERIORITY|||||||0.656||||||P-value for change in PAQ from BL to 24-Months: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.656
73968974|NCT03241459|147476375|SUPERIORITY|||||||0.959||||||P-value for change in PAQ from BL to 12-Months:Summary Score|Wilcoxon (Mann-Whitney)|||||||0.959
73968975|NCT03241459|147476376|SUPERIORITY|||||||1||||||P-Value at 36-Months|Fisher Exact|||||||1.0
73968976|NCT03241459|147476376|SUPERIORITY|||||||0.903||||||P-Value at 48-Months|Fisher Exact|||||||0.903
73968977|NCT03241459|147476376|SUPERIORITY|||||||1||||||P-Value at 60-Months|Fisher Exact|||||||1.0
73968978|NCT03241459|147476377|SUPERIORITY|||||||0.913|||||||Fisher Exact|P-Value at 36-Months||||||0.913
73968979|NCT03241459|147476377|SUPERIORITY|||||||1|||||||Fisher Exact|P-Value at 48-Months||||||1.0
73968980|NCT03241459|147476377|SUPERIORITY|||||||0.839||||||P-Value at 60-Months|Fisher Exact|||||||0.839
73968981|NCT03241459|147476378|SUPERIORITY|||||||1||||||P-Value at 36-Months|Fisher Exact|||||||1.0
73968982|NCT03241459|147476378|SUPERIORITY|||||||0.5|||||||Fisher Exact|P-Value at 48-Months||||||0.5
73968983|NCT03241459|147476378|SUPERIORITY|||||||0.251|||||||Fisher Exact|P-Value at 60-Months||||||0.251
73968984|NCT03241459|147476379|SUPERIORITY|||||||0.478||||||P-Value at 36-Months|Fisher Exact|||||||0.478
73968985|NCT03241459|147476379|SUPERIORITY|||||||0.605||||||P-Value at 48-Months|Fisher Exact|||||||0.605
73968986|NCT03241459|147476379|SUPERIORITY|||||||0.345||||||P-Value at 60-Months|Fisher Exact|||||||0.345
73968987|NCT05480124|147476380|SUPERIORITY|||||||0.609|||||||t-test, 2 sided|||||||0.609
73968988|NCT05480124|147476382|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
73968989|NCT05480124|147476383|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
73968990|NCT05480124|147476384|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||||||0.383
73968991|NCT05480124|147476385|SUPERIORITY|||||||0.201|||||||t-test, 2 sided|||||||0.201
73968992|NCT02761057|147476391|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.019|TWO_SIDED|95.0|0.37|0.97|||Regression, Cox|||A proportional hazards model was used to compare the Hazard Ratio (HR) for PFS.||0.97|0.37|0.019
73968993|NCT02761057|147476392|SUPERIORITY|||||||0.1|||||||Chi-squared|||The Chi-Square test will be used to compare RR between sunitinib and cabozantinib.||||0.10
73968994|NCT02761057|147476393|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.47|1.51|||Log Rank|||The log-rank test will be used to compare OS.||1.51|0.47|
73968995|NCT03365882|147476440|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.44|TWO_SIDED|95.0|0.43|1.45|||Log Rank|||||1.45|0.43|0.44
73968996|NCT03365882|147476442|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
73968997|NCT04323137|147476444|SUPERIORITY|||||||0.0035|||||||Regression, Logistic|||"This analysis compared all groups that were informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm) to control patients who were not sent a message.~Null hypothesis: informing patients they are high risk for flu and flu-related complications does not increase flu vaccination rate; Alternative hypothesis: informing patients they are high risk for flu and flu-related complications increases flu vaccination rate"||||0.0035
73968998|NCT04323137|147476444|SUPERIORITY|||||||0.613||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk only and High risk based on medical records messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk only and High risk based on medical records. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||.613
74029016|NCT02544984|147612147|SUPERIORITY|||||||0.435|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||||||0.435
74029017|NCT00700752|147612207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1636|STANDARD_ERROR_OF_MEAN|0.1887|||TWO_SIDED|95.0|0.789|1.1636|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus balafilcon A.|Alternative hypothesis is senofilcon A is superior to balafilcon A for comfort.||1.1636|0.7890|
74029018|NCT02522377|147612229|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.22|STANDARD_ERROR_OF_MEAN|3.28||0.72|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.72
74087275|NCT01117766|147728459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|0.722||0.1753|TWO_SIDED|95.0|-2.6|0.53|||ANCOVA|||Week 3 (Visits 3 and 6)||0.53|-2.60|0.1753
73968999|NCT04323137|147476444|SUPERIORITY|||||||0.889||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk only and High risk based on algorithm messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk only and High risk based on algorithm messages. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||0.889
73969000|NCT04323137|147476444|SUPERIORITY|||||||0.714||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk based on medical records and High risk based on algorithm messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk based on medical records and High risk based on algorithm messages. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||.714
73969001|NCT04323137|147476445|SUPERIORITY|||||||0.181||||||This p-value is from the same regression as the top 10% risk vs. top 3% risk contrast (analysis 2).|Regression, Logistic|||"This analysis tested whether vaccination differed in patients with the same risk level who were sent messages with a vague verbal (high risk) vs. specific numeric (top 10%) risk framing.~This analysis was limited to those informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm)."||||.181
73969002|NCT04323137|147476445|SUPERIORITY|||||||0.301||||||This p-value is from the same regression as the high risk vs. top 10% risk contrast (analysis 1).|Regression, Logistic|||"This analysis tested whether vaccination differed in patients with the same numeric risk phrasing are differentially affected due to different specific risk levels (3% vs. 10%).~This analysis was limited to those informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm)."||||.301
73926092|NCT01480076|147379714|SUPERIORITY_OR_OTHER||difference of LS means|-11.7|STANDARD_ERROR_OF_MEAN|15.88||0.4635|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4635
73926093|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.1392|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1392
73969003|NCT04229992|147476462|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level||"1. GG genotype and magnesium treatment vs GG genotype and placebo;~2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo."||||<0.05
73969004|NCT04229992|147476463|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level||"1. GG genotype and magnesium treatment vs GG genotype and placebo;~2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo"||||<0.05
73969005|NCT03770273|147476464|OTHER|||||||0.774|||||||Regression, Linear|||||||0.7740
74029019|NCT02522377|147612230|SUPERIORITY|Superiority test based upon group differences pooled across infusions in mixed effect model|Mean Difference (Final Values)|1.98|STANDARD_ERROR_OF_MEAN|6.4||0.77|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=7.836.|Midazolam - Ketamine Infusions|||||0.77
74029020|NCT02522377|147612231|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|1.12||0.4|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.40
73969006|NCT03770273|147476466|OTHER|||||||0.1071|||||||Regression, Linear|||||||0.1071
73969007|NCT03770273|147476467|OTHER|||||||0.4904|||||||Regression, Linear|||||||0.4904
73969008|NCT03770273|147476468|OTHER|||||||0.1399|||||||Regression, Linear|||||||0.1399
73969009|NCT05177848|147476479|OTHER|||||||0.9793||||||"A linear mixed effects model tested the interaction between group and condition on the rate of substitution~Results:~Condition: X2(6) = 4.30, p = 0.64 Group: X2(1) 0.22, p = 0.64 Condition:Group: X2(6) = 1.15, p = 0.98"|Mixed Models Analysis|||||||0.9793
73969010|NCT05177848|147476480|OTHER|||||||0.29||||||"A linear mixed effects model tested the interaction between group and condition on Q0 (derived intensity).~Results:~Condition: X2(6) = 6.59, p = 0.36 Group: X2(1) = 0.07, p = 0.79 Condition:Group: X2(6) = 7.38, p = 0.29"|Mixed Models Analysis|||||||0.29
73969011|NCT05177848|147476480|OTHER|||||||0.46||||||"A linear mixed effects model tested the interaction between group and condition on Alpha (demand elasticity).~Results:~Condition: X2(6) = 0.0001, p = 1.00 Group: X2(1) = 0.00, p = 0.99 Condition:Group: X2(6) = 5.65, p = 0.46"|Mixed Models Analysis|||||||0.46
73969012|NCT01084876|147476498|EQUIVALENCE|The therapeutic equivalence between CT-P6 and Herceptin is concluded if the 95% confidence interval (CI) for the risk difference (CT-P6 - Herceptin) estimate in ORR ITRC review during the Main Study Treatment Period is entirely within the predefined equivalence margin of -0.15 to 0.15.|Risk Difference (RD)|-0.0535|||||TWO_SIDED|95.0|-0.143|0.036||||||||0.036|-0.143|
73969013|NCT05386758|147476506|OTHER||Gemetric Mean Ratio (GMR)|1.24|||||TWO_SIDED|90.0|0.94|1.64||||||||1.64|0.94|
73969014|NCT05386758|147476507|OTHER||Geometric Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|0.9|1.62||||||||1.62|0.90|
74029021|NCT02522377|147612232|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.78|STANDARD_ERROR_OF_MEAN|0.54||0.009|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.3634.|Midazolam - Ketamine Infusions|||||0.009
74087276|NCT01117766|147728459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|0.588||0.0198|TWO_SIDED|95.0|-2.75|-0.27|||ANCOVA|||Week 4 (Visits 4 and 7)||-0.27|-2.75|0.0198
73862327|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.89||||||90.0|0.12|5.67|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||5.67|0.12|
73862328|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.06||||||90.0|-0.71|4.83|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||4.83|-0.71|
73926094|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.1448|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1448
73926095|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.0187|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0187
73926096|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.292|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2920
73926097|NCT01480076|147379715|SUPERIORITY_OR_OTHER||difference of LS means|4.2|STANDARD_ERROR_OF_MEAN|4.95||0.3968|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3968
73969015|NCT04509674|147476568|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.2061|TWO_SIDED|95.0|0.76|1.06||"Null hypothesis: there is no difference regarding the risk of the endpoint in question between empagliflozin and placebo.~p\<=0.05 required for testing of subsequent key secondary endpoint hypotheses"|Regression, Cox||Empagliflozin vs. Placebo|The primary endpoint was analysed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.||1.06|0.76|0.2061
73969016|NCT04509674|147476569|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.87||||0.2423|TWO_SIDED|95.0|0.68|1.1|||Negative binomial regression||Empagliflozin vs. Placebo|||1.10|0.68|0.2423
73969017|NCT04509674|147476570|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.92||||0.2867|TWO_SIDED|95.0|0.78|1.07|||Negative binomial regression||Empagliflozin vs. Placebo|||1.07|0.78|0.2867
74029022|NCT02522377|147612233|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|3.72|STANDARD_ERROR_OF_MEAN|3.71||0.34|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.34
73969018|NCT04509674|147476571|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.87||||0.0463|TWO_SIDED|95.0|0.7654|0.9978|||Negative binomial regression||Empagliflozin vs. Placebo|||0.9978|0.7654|0.0463
73969019|NCT04509674|147476572|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|1.06||||0.6311|TWO_SIDED|95.0|0.83|1.35|||Negative binomial regression||Empagliflozin vs. Placebo|||1.35|0.83|0.6311
74029023|NCT02522377|147612234|SUPERIORITY||Odds Ratio (OR)|0.36||||0.58|TWO_SIDED|95.0|0.01|7.2|||Fisher Exact||Odds Ratio of Midazolam (numerator) to Ketamine Infusions (denominator)|||7.20|0.01|0.58
73862329|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.45||||||90.0|2.68|8.22|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||8.22|2.68|
73862330|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12||||||90.0|1.34|6.89|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.89|1.34|
73926098|NCT01480076|147379715|SUPERIORITY_OR_OTHER||difference of LS means|5.1|STANDARD_ERROR_OF_MEAN|10.95||0.642|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6420
73926099|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.01|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0100
73969020|NCT04509674|147476573|OTHER|The statistical analysis was performed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.|Hazard Ratio (HR)|1.03||||0.8124||95.0|0.81|1.31|||Regression, Cox||Empagliflozin vs. Placebo|||1.31|0.81|0.8124
73969021|NCT03721952|147476652|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.13|STANDARD_ERROR_OF_MEAN|0.323||0.688|TWO_SIDED|95.0|-0.505|0.764|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average depression score \& negative sign of estimate defined as higher average depression score, over 3 follow-up points for the intervention group vs. the control group.|Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||0.764|-0.505|0.688
73969022|NCT03721952|147476652|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.510
74029024|NCT01765712|147612240|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.55|TWO_SIDED|95.0|-1.99|1.03|||t-test, 2 sided|||||1.03|-1.99|0.55
74029025|NCT04036136|147612281|EQUIVALENCE|The equivalence margin is 0.|Mean Difference (Final Values)|-0.36||||0.724|TWO_SIDED|95.0|-2.41|1.68|||ANCOVA|||Model covariates are Baseline SHAPS, age, and sex.||1.68|-2.41|0.724
74029026|NCT04036136|147612282|EQUIVALENCE|The equivalence margin is 0.|Mean Difference (Final Values)|-0.043||||0.292|TWO_SIDED|95.0|-0.124|0.038|||Regression, Linear|||Model covariates are Baseline fMRI, age, and sex.||0.038|-0.124|0.292
74087277|NCT01117766|147728460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.29|STANDARD_ERROR_OF_MEAN|6.292||0.4999|TWO_SIDED|95.0|-17.13|8.54|||ANCOVA|||||8.54|-17.13|0.4999
73926100|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.8634|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8634
73969023|NCT03721952|147476653|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.143|STANDARD_ERROR_OF_MEAN|0.323||0.658|TWO_SIDED|95.0|-0.491|0.777|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average anxiety score \& negative sign of estimate defined as higher average anxiety score, over 3 follow-up points for the intervention group vs. the control group.|Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||0.777|-0.491|0.658
73969024|NCT03721952|147476653|SUPERIORITY|||||||0.268|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.268
73969025|NCT03721952|147476654|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.2|STANDARD_ERROR_OF_MEAN|0.077||0.01|TWO_SIDED|95.0|-0.353|-0.048|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average quality-of-relationship score \& negative sign of estimate defined as higher average quality-of-relationship score over 3 follow-up points for intervention vs control groups.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||-0.048|-0.353|0.010
73969026|NCT03721952|147476654|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.175
74029027|NCT04036136|147612283|EQUIVALENCE|The equivalence margin is 0.|Median Difference (Final Values)|-0.148||||0.084|TWO_SIDED|95.0|-0.316|0.02||The equivalence margin is 0.|Regression, Linear|||Model covariates are Baseline fMRI, age, and sex.||0.020|-0.316|0.084
74029028|NCT02961764|147612292|SUPERIORITY||Odds Ratio (OR)|0.289|||<|0.001|TWO_SIDED|95.0|0.156|0.532|||Fisher Exact|||||0.532|0.156|<0.001
74029029|NCT02961764|147612293|SUPERIORITY|||||||0.005|||||||t-test, 1 sided|||||||0.005
74029030|NCT02961764|147612294|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|||||||0.050
74029031|NCT02961764|147612296|SUPERIORITY|||||||0.002|||||||t-test, 1 sided|||||||0.002
74029032|NCT01422304|147612327|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.38|1.29|||Cochran-Mantel-Haenszel||Relative risk is Sugammadex versus Usual Care|Cochran-Mantel-Haenszel method was stratified for renal function (estimated creatinine clearance \< or ≥ 60 mL/min) and prophylactic antithrombotic therapy (including low molecular weight heparin \[LMWH\], including unfractionated heparin \[UFH\], or not including either LMWH or UFH)||1.29|0.38|
74087278|NCT00438659|147728461|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
74087279|NCT00440115|147728473|SUPERIORITY|Power calculations demonstrated that 250 participants per group would have 95% power to compare combined high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.12||||0.54|TWO_SIDED|95.0|0.78|1.61|||Mixed Models Analysis||(High-intensity disease management and moderate-intensity disease management) vs pharmacotherapy management|||1.61|0.78|0.54
73926101|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.0134|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0134
73926102|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.8147|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8147
73926103|NCT01480076|147379715|SUPERIORITY_OR_OTHER||difference of LS means|-5.1|STANDARD_ERROR_OF_MEAN|6.06||0.4035|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4035
73926104|NCT01480076|147379715|SUPERIORITY_OR_OTHER||difference of LS means|-4.8|STANDARD_ERROR_OF_MEAN|14.25||0.7385|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7385
73926105|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.0139|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0139
73926106|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.5207|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5207
73926107|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.0091|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0091
73926108|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.2312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2312
73926109|NCT01480076|147379715|SUPERIORITY_OR_OTHER||difference of LS means|-1.8|STANDARD_ERROR_OF_MEAN|5.89||0.7578|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7578
73926110|NCT01480076|147379715|SUPERIORITY_OR_OTHER||difference of LS means|7.9|STANDARD_ERROR_OF_MEAN|13.42||0.5575|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5575
74029033|NCT01422304|147612328|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR) (%)|5.5|||||TWO_SIDED|95.0|3.7|7.3|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||7.3|3.7|
73926111|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.4486|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4486
73926112|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.0102|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0102
73926113|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.1185|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1185
73926114|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.7523|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7523
73926115|NCT01480076|147379715|SUPERIORITY_OR_OTHER||difference of LS means|17.1|STANDARD_ERROR_OF_MEAN|7.38||0.0214|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0214
73926116|NCT01480076|147379715|SUPERIORITY_OR_OTHER||difference of LS means|0.4|STANDARD_ERROR_OF_MEAN|19.12||0.9826|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9826
73969027|NCT03721952|147476655|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.021|STANDARD_ERROR_OF_MEAN|0.092||0.817|TWO_SIDED|95.0|-0.203|0.16|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average quality-of-relationship score \& negative sign of estimate defined as higher average quality-of-relationship score, over 3 follow-up points for intervention vs control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.160|-0.203|0.817
73969028|NCT03721952|147476655|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.949
73969029|NCT03721952|147476656|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.45|STANDARD_ERROR_OF_MEAN|0.239||0.06|TWO_SIDED|95.0|-0.919|0.02|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average preparation score \& negative sign of estimate defined as higher average preparation score, over 3 follow-up points for intervention vs control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.020|-0.919|0.060
73969030|NCT03721952|147476656|SUPERIORITY|||||||0.701|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.701
73969031|NCT03721952|147476657|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.393||||0.053|TWO_SIDED|95.0|-0.791|0.005|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average goal-concordant care \& negative sign of estimate defined as higher average goal-concordant care, over 3 follow-up points for intervention group vs. control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.005|-0.791|0.053
73969032|NCT03721952|147476657|SUPERIORITY|||||||0.039|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.039
73969033|NCT03721952|147476658|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.636||||0.239|TWO_SIDED|95.0|-0.425|1.7|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.||Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||1.700|-0.425|0.239
73969034|NCT03721952|147476658|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.170
74029034|NCT01422304|147612328|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|0.9||||||95.0|-0.9|2.8|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||2.8|-0.9|
74029779|NCT03151148|147614041|SUPERIORITY||Geometric mean ratio (GMR)|32.638||||0.057|TWO_SIDED|95.0|0.8994|1184.4298|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1184.4298|0.8994|0.057
73926117|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.6627|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6627
73926118|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.4674|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4674
73926119|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.2965|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2965
73926120|NCT01480076|147379715|SUPERIORITY_OR_OTHER|||||||0.1778|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1778
73926121|NCT01480076|147379715|SUPERIORITY_OR_OTHER||difference of LS means|6.6|STANDARD_ERROR_OF_MEAN|7.65||0.3903|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3903
73926122|NCT01480076|147379715|SUPERIORITY_OR_OTHER||difference of LS means|16.8|STANDARD_ERROR_OF_MEAN|15.53||0.2794|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2794
73926123|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.0628|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0628
73926124|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.1166|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1166
73926125|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.0451|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0451
73926126|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.9327|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9327
73969035|NCT03721952|147476659|SUPERIORITY||Slope|0.089|STANDARD_ERROR_OF_MEAN|0.041||0.029|TWO_SIDED|95.0|0.009|0.169|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher proportion of readmissions \& negative sign of estimate defined as lower proportion of readmissions, for the intervention group vs. the control group|Superior outcome for Group2 (Patient-Intervention)||0.169|0.009|0.029
73969036|NCT03721952|147476660|SUPERIORITY||Slope|1.078|STANDARD_ERROR_OF_MEAN|0.808||0.183|TWO_SIDED|95.0|-0.511|2.666|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||2.666|-0.511|0.183
73926127|NCT01480076|147379716|SUPERIORITY_OR_OTHER||difference of LS means|5.1|STANDARD_ERROR_OF_MEAN|6.28||0.4177|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4177
73862331|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.45||||||90.0|0.68|6.22|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.22|0.68|
73926128|NCT01480076|147379716|SUPERIORITY_OR_OTHER||difference of LS means|-7.9|STANDARD_ERROR_OF_MEAN|14.64||0.5885|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5885
73926129|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.0059|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0059
73926130|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.3467|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3467
73926131|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.0654|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0654
73926132|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.3965|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3965
73926133|NCT01480076|147379716|SUPERIORITY_OR_OTHER||difference of LS means|-1.3|STANDARD_ERROR_OF_MEAN|7.11||0.8548|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8548
73969037|NCT03721952|147476661|SUPERIORITY||Slope|1.687|STANDARD_ERROR_OF_MEAN|3.157||0.593|TWO_SIDED|95.0|-4.518|7.892|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||7.892|-4.518|0.593
73969038|NCT03721952|147476662|SUPERIORITY||Slope|4.365|STANDARD_ERROR_OF_MEAN|6.987||0.533|TWO_SIDED|95.0|-9.367|18.097|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||18.097|-9.367|0.533
73969039|NCT03721952|147476663|SUPERIORITY||Slope|1.07|STANDARD_ERROR_OF_MEAN|1.07||0.318|TWO_SIDED|95.0|-1.032|3.173|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||3.173|-1.032|0.318
73969040|NCT03721952|147476664|SUPERIORITY||Slope|4.117|STANDARD_ERROR_OF_MEAN|3.506||0.241|TWO_SIDED|95.0|-2.773|11.007|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||11.007|-2.773|0.241
73969041|NCT03721952|147476665|SUPERIORITY||Slope|8.195|STANDARD_ERROR_OF_MEAN|7.466||0.273|TWO_SIDED|95.0|-6.479|22.868|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||22.868|-6.479|0.273
73969042|NCT03721952|147476666|SUPERIORITY||Slope|-0.0000009|STANDARD_ERROR_OF_MEAN|0.00000248||0.71|TWO_SIDED|95.0|-0.0000057|0.0000039|||other type of regression|Regression \[gamma family, link function g(u)=u-0.9\], outcome on random group (0=control, 1=intervention), adjusted for hospital, robust SEs.||Superior outcome for Group2 (Patient-Intervention)||0.0000039|-0.0000057|0.710
73862332|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.33||||||90.0|3.7|10.95|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||10.95|3.70|
73926134|NCT01480076|147379716|SUPERIORITY_OR_OTHER||difference of LS means|-25.1|STANDARD_ERROR_OF_MEAN|21.35||0.2405|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2405
74029035|NCT01422304|147612329|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|3.0|||||TWO_SIDED|95.0|1.3|4.7|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||4.7|1.3|
74029036|NCT01422304|147612329|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|0.9|||||TWO_SIDED|95.0|-1.0|2.9|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||2.9|-1.0|
74029037|NCT01422304|147612330|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-0.6|||||TWO_SIDED|95.0|-3.0|1.8|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.8|-3.0|
74029038|NCT01422304|147612331|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-1.4|||||TWO_SIDED|95.0|-3.4|0.5|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||0.5|-3.4|
74029039|NCT01422304|147612332|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-0.9|||||TWO_SIDED|95.0|-3.1|1.2|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.2|-3.1|
74029040|NCT01422304|147612333|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|0.3|||||TWO_SIDED|95.0|-0.7|1.5|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.5|-0.7|
74029041|NCT01422304|147612335|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-45.0|30.5|||Generalized Linear Model||Difference is Sugammadex versus Usual Care. A negative value indicates that the average adjusted drainage volume was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site.||30.5|-45.0|
73926135|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0056
73926136|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.8105|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8105
73926137|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.047|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0470
73926138|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.6067|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6067
73926139|NCT01480076|147379716|SUPERIORITY_OR_OTHER||difference of LS means|-6.0|STANDARD_ERROR_OF_MEAN|7.56||0.4309|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4309
73926140|NCT01480076|147379716|SUPERIORITY_OR_OTHER||difference of LS means|0.5|STANDARD_ERROR_OF_MEAN|16.09||0.9761|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9761
74029042|NCT01422304|147612336|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-2.7|||||TWO_SIDED|95.0|-7.4|2.0|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence, adjusted for strata and investigational site|Miettinen and Nurminen Method was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site||2.0|-7.4|
73926141|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.6261|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6261
73969043|NCT03721952|147476667|SUPERIORITY||Slope|0.00000113|STANDARD_ERROR_OF_MEAN|0.00000215||0.599|TWO_SIDED|95.0|-0.000003|0.0000053|||other type of regression|Regression \[inverse Gaussian family, link function g(u)=u-0.9\], outcome on random group (0=control,1=intervention), adjusted for hospital, robust SEs.||Superior outcome for Group2 (Patient-Intervention)||0.0000053|-0.0000030|0.599
73969044|NCT04541147|147476725|EQUIVALENCE|Test if the number of doses in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Mean Difference (Final Values)|6.9|STANDARD_DEVIATION|10.1||0.16|TWO_SIDED|95.0|-2.9|16.7|||t-test, 2 sided|||||16.7|-2.9|0.16
73969045|NCT04541147|147476726|EQUIVALENCE|Test if the average pain score in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|1.4||0.56|TWO_SIDED|95.0|-1.8|1.0|||t-test, 2 sided|||||1.0|-1.8|0.56
73926142|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.086|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0860
73926143|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.2884|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2884
73926144|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.8854|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8854
74029043|NCT01422304|147612337|SUPERIORITY_OR_OTHER_LEGACY||GMR|1.1|||||TWO_SIDED|95.0|0.98|1.24|||Generalized Linear Model||GMR is Sugammadex versus Usual Care|Generalized Linear Model was applied to transfusion volume transformed to the log-scale, adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site. Result and 95% Confidence Interval was transformed back to the original scale.||1.24|0.98|
74087280|NCT00440115|147728473|SUPERIORITY|Power calculations indicated that 250 participants per group would have 80% power to compare high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.33||||0.18|TWO_SIDED|95.0|0.88|2.02|||Mixed Models Analysis||High-intensity disease management vs moderate-intensity disease management|||2.02|0.88|0.18
73926145|NCT01480076|147379716|SUPERIORITY_OR_OTHER||difference of LS means|16.9|STANDARD_ERROR_OF_MEAN|10.88||0.1226|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1226
73926146|NCT01480076|147379716|SUPERIORITY_OR_OTHER||difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|26.07||0.7249|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7249
73969046|NCT04541147|147476727|EQUIVALENCE|Test if the Number of participants with post-operative complications in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.15||1|TWO_SIDED|95.0|-0.22|0.36|||Fisher Exact|||||0.36|-0.22|1.00
73969047|NCT04064164|147476772|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.004||||||Dear (root word)|Chi-squared|X-squared = 8.4 df=1||||||.004
73969048|NCT04064164|147476772|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App. Significant associations indicated the human and app were accurately identifying true positives (1:1) or true negatives (0:0).|||||<|0.001||||||Sweet (root word)|Chi-squared|X-squared = 20.20 df=1||||||<.001
73969049|NCT04064164|147476772|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.02||||||Girl (root word)|Chi-squared|X-squared = 5.08, df=1||||||.02
73969050|NCT04064164|147476772|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.1||||||Honey (root word)|Chi-squared|X-squared = 2.7, df= 1||||||.10
74029044|NCT01422304|147612338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-0.4|3.1|||Generalized Linear Model||Difference is Sugammadex versus Usual Care. A positive value indicates that the average adjusted reduction in Hgb at Visit 3 (bleeding index) was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy), investigational site and baseline hemoglobin value.||3.1|-0.4|
74087281|NCT03069417|147728478|SUPERIORITY|Conducted at post-treatment time point.||||||0.11|||||||Mixed Models Analysis|||||||0.11
73926147|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.5129|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5129
74087282|NCT03069417|147728478|SUPERIORITY|Conducted at 3-month follow-up time point.||||||0.56|||||||Mixed Models Analysis|||||||0.56
73926148|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.1138|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1138
73926149|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.1086|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1086
73926150|NCT01480076|147379716|SUPERIORITY_OR_OTHER|||||||0.5746|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5746
73926151|NCT01480076|147379716|SUPERIORITY_OR_OTHER||difference of LS means|10.8|STANDARD_ERROR_OF_MEAN|8.07||0.1831|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1831
73926152|NCT01480076|147379716|SUPERIORITY_OR_OTHER||difference of LS means|2.1|STANDARD_ERROR_OF_MEAN|15.54||0.8917|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8917
73926153|NCT01480076|147379717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926154|NCT01480076|147379717|SUPERIORITY_OR_OTHER|||||||0.1152|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1152
73926155|NCT01480076|147379717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926156|NCT01480076|147379717|SUPERIORITY_OR_OTHER|||||||0.4578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4578
73926157|NCT01480076|147379717|SUPERIORITY_OR_OTHER||difference of LS means|-6.4|STANDARD_ERROR_OF_MEAN|2.56||0.0125|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0125
73926158|NCT01480076|147379717|SUPERIORITY_OR_OTHER||difference of LS means|-10.2|STANDARD_ERROR_OF_MEAN|4.23||0.0158|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0158
73969051|NCT04064164|147476772|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.85||||||Baby (root word)|Chi-squared|X-squared = 12.2, df = 1||||||0.85
74087283|NCT03069417|147728479|SUPERIORITY|Main effect for time calculated at 3-month follow-up time point.|Fixed effects coefficient (β)|-12.7|||<|0.05|TWO_SIDED|95.0|-22.29|-3.15||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.15|-22.29|< 0.05
74087284|NCT03069417|147728480|SUPERIORITY|Interaction evaluated at post-treatment time point.|Fixed effects coefficient (β)|-11.1|||<|0.005|TWO_SIDED|95.0|-18.41|-3.83||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.83|-18.41|< 0.005
74029045|NCT01422304|147612339|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-1.6|||||TWO_SIDED|95.0|-6.3|3.1|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||3.1|-6.3|
73926159|NCT01480076|147379717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926160|NCT01480076|147379717|SUPERIORITY_OR_OTHER|||||||0.2894|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2894
73926161|NCT01480076|147379717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926162|NCT01480076|147379717|SUPERIORITY_OR_OTHER|||||||0.723|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7230
73926163|NCT01480076|147379717|SUPERIORITY_OR_OTHER||difference of LS means|-9.3|STANDARD_ERROR_OF_MEAN|3.2||0.0038|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0038
73926164|NCT01480076|147379717|SUPERIORITY_OR_OTHER||difference of LS means|-13.9|STANDARD_ERROR_OF_MEAN|5.37||0.0097|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0097
73926165|NCT01480076|147379717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926166|NCT01480076|147379717|SUPERIORITY_OR_OTHER|||||||0.0628|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0628
73926167|NCT01480076|147379717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926168|NCT01480076|147379717|SUPERIORITY_OR_OTHER|||||||0.9232|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9232
73926169|NCT01480076|147379717|SUPERIORITY_OR_OTHER||difference of LS means|-5.2|STANDARD_ERROR_OF_MEAN|3.37||0.1249|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1249
74029046|NCT00866294|147612341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.8|-1.1||The hypothesis test was conducted with a two-sided significance level of 5% to show the superiority of paroxetine CR relative to placebo.|ANCOVA|The primary analysis was based on an ANCOVA with a model adjusting for baseline HAM-D total score and region (Japan and South Korea).|Mean difference = paroxetine CR minus placebo|||-1.1|-3.8|<0.001
74029047|NCT00916721|147612348|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|Multiple significance testing:we adjusted p-value by controlling the expected proportion of falsely rejected hypotheses:false discovery rate,Benjamini||||||0.05
73926170|NCT01480076|147379717|SUPERIORITY_OR_OTHER||difference of LS means|-14.1|STANDARD_ERROR_OF_MEAN|5.42||0.0093|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0093
73926171|NCT01480076|147379717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926172|NCT01480076|147379717|SUPERIORITY_OR_OTHER|||||||0.0937|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0937
73926173|NCT01480076|147379717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926174|NCT01480076|147379717|SUPERIORITY_OR_OTHER|||||||0.7814|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7814
73926175|NCT01480076|147379717|SUPERIORITY_OR_OTHER||difference of LS means|-3.9|STANDARD_ERROR_OF_MEAN|3.47||0.2561|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2561
73926176|NCT01480076|147379717|SUPERIORITY_OR_OTHER||difference of LS means|-13.6|STANDARD_ERROR_OF_MEAN|6.07||0.0255|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0255
73926177|NCT01480076|147379717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73926178|NCT01480076|147379717|SUPERIORITY_OR_OTHER|||||||0.7241|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7241
73969052|NCT04059484|147476788|SUPERIORITY||Hazard Ratio (HR)|1.051||||0.6437|TWO_SIDED|95.0|0.789|1.4||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025 level.|Stratified Log-Rank test|Stratified on presence of visceral metastasis, prior treatment with CDK4/6 inhibitors and ECOG according to IRT.|Amcenestrant versus PCEM|A hierarchical testing procedure was used to ensure a strong control of the overall Type I error. Testing was then performed sequentially in order the outcome measures was reported and continued when previous outcome measure was statistically significant at one-sided 2.5% for the primary and the first secondary outcome.||1.4|0.789|0.6437
73969053|NCT01000961|147476839|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority endpoint of the clinical trial would be achieved if the upper limit of the 95.8% CI of the difference between RP103 and Cystagon® was less than the a-priori 0.3 non-inferiority margin, which would correspond to an observed p-value less than or equal to 0.02104|Mean Difference (Final Values)|0.0785||||0.0001|TWO_SIDED|95.8|0.0107|0.1464|||t-test, 1 sided||95.8% confidence interval was used instead of 95% to take into account a sample size re-estimation calculation that was performed after 20 patients were enrolled.|16-subject study will have 90% power to reject the null hypothesis of non-inferiority at the 0.025 level of significance with a non-inferiority margin of 0.3. Final analysis was performed at a nominal significance level of 0.02104.||0.1464|0.0107|0.0001
73969054|NCT01000961|147476840|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.4|||||TWO_SIDED|95.0|1.17|1.67||||||||1.67|1.17|
73969055|NCT01000961|147476841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|105.0|||||TWO_SIDED|95.0|90.0|150.0||||||||150|90|
73969056|NCT01000961|147476842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.03|||||TWO_SIDED|95.0|1.75|2.39||||||||2.39|1.75|
74029048|NCT02101411|147612376|OTHER|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Hazard Ratio (HR)|1.19|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Chi-squared|The differences among the three PRU groups (\<85, 85-208,\>208) and ADEs were compared using the Chi-squared test.||The differences among the three PRU groups (\<85, 85-208,\>208) and MACE rate at 24 months were compared using the Chi-squared test. was recorded.||||0.002
73926179|NCT01480076|147379717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
73969057|NCT03896789|147476896|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.95|TWO_SIDED|95.0|-3.3|3.5||The primary outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.|Mixed Models Analysis|Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.||"Null hypothesis: Assuming no difference between usual care (control) and PEGASUS (intervention).~We used 2011-2012 results from prior pilot work in Argentina (58.6% TBI guideline adherence) to determine a sample size of 432 eligible patients (216 per arm) for the planned parallel cluster RCT, which would have 80% power to detect a 18.7% higher ICU TBI guideline adherence rate with programme implementation, with a two-sided alpha of 5%, and an intraclass coefficient of 0.05."||3.5|-3.3|.95
73969058|NCT03896789|147476902|SUPERIORITY||Mean Difference (Final Values)|7.9||||0.01|TWO_SIDED|95.0|1.9|13.8||The outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.|Mixed Models Analysis|Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.||||13.8|1.9|.01
73969059|NCT05794243|147476933|OTHER||Ratio of Geometric Least Squares Means|0.13|||||TWO_SIDED|90.0|0.0741|0.228|||Mixed Models Analysis|||AUC (0-∞) was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The least square means (LSMs) and differences in LSMs were back transformed to produce the ratio between geometric least square means (GLSMs).||0.228|0.0741|
73969060|NCT05794243|147476933|OTHER||Ratio of Geometric Least Squares Means|0.399|||||TWO_SIDED|90.0|0.237|0.669|||Mixed Models Analysis|||AUC (0-∞) was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.669|0.237|
74087285|NCT03069417|147728480|SUPERIORITY|Main effect for time at 3-month follow-up time point.|Fixed effects coefficient (β)|-13.8|||<|0.005|TWO_SIDED|95.0|-22.5|-5.17||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-5.17|-22.50|< 0.005
74087286|NCT03069417|147728482|SUPERIORITY|Main effect for condition.|Fixed effects coefficient (β)|-10.1|||<|0.05|TWO_SIDED|95.0|-19.58|-0.67||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-0.67|-19.58|< 0.05
73969061|NCT05794243|147476935|OTHER||Ratio of Geometric Least Squares Means|0.106|||||TWO_SIDED|90.0|0.062|0.182|||Mixed Models Analysis|||Cmax was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.182|0.0620|
73969062|NCT05794243|147476935|OTHER||Ratio of Geometric Least Squares Means|0.343|||||TWO_SIDED|90.0|0.206|0.569|||Mixed Models Analysis|||Cmax was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.569|0.206|
73969063|NCT04788511|147476936|SUPERIORITY||Estimated Treatment Difference|7.8|||<|0.0001|TWO_SIDED|95.0|4.8|10.9|||ANCOVA|||The responses at week 52 were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\<35.0 kg/m\^2, BMI\>=35.0 kg/m\^2) as factors and baseline KCCQ-CSS as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.||10.9|4.8|<0.0001
73969064|NCT04788511|147476937|SUPERIORITY||Estimated Treatment Difference|-10.7|||<|0.0001|TWO_SIDED|95.0|-11.9|-9.4|||ANCOVA|||The responses were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\<35.0 kg/m\^2, BMI\>=35.0 kg/m\^2) as factors and baseline body weight (kg) as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.||-9.4|-11.9|<0.0001
73969065|NCT03637660|147476951|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.002|TWO_SIDED|90.0|-0.15|0.03||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|To assess the primary efficacy endpoint, the number and proportion of participants with a serological response by Month 6 and the 95% confidence interval were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis for the primary objective was that the difference in proportion of participants with serological responses between the three-dose and one-dose groups was at least 10%||0.03|-0.15|0.002
74087287|NCT03069417|147728482|SUPERIORITY|Main effect for time at post-treatment time point.|Fixed effects coefficient (β)|-12.8|||<|0.01|TWO_SIDED|95.0|-22.14|-3.37||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.37|-22.14|< 0.01
74087288|NCT03069417|147728483|SUPERIORITY|Main effect for condition.|Fixed effects coefficient (β)|6.2|||<|0.05|TWO_SIDED|95.0|0.5|11.88||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||11.88|0.50|< 0.05
74087289|NCT04117945|147728500|SUPERIORITY|||||||0.8874|||||||One-sided unstratified log-rank|||||||0.8874
74087290|NCT04117945|147728501|SUPERIORITY|||||||0.9683|||||||One-sided unstratified log-rank|||||||0.9683
74087291|NCT04117945|147728502|SUPERIORITY|||||||0.0448|||||||One-sided unstratified log-rank|||||||0.0448
74087292|NCT04117945|147728503|SUPERIORITY|||||||0.9007|||||||One-sided unstratified log-rank|||||||0.9007
74087293|NCT01917968|147728516|SUPERIORITY||Adjusted difference in percentages|6.5||||0.056|TWO_SIDED|90.0|-0.2|13.2||Statistical significance is considered at 0.05 level.|Z statistics|P-value is calculated using a Z statistics from the propensity score adjusted estimates. Missing values are handled using multiple imputation.||||13.2|-0.2|0.056
73926180|NCT01480076|147379717|SUPERIORITY_OR_OTHER|||||||0.0427|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0427
73926181|NCT01480076|147379717|SUPERIORITY_OR_OTHER||difference of LS means|-7.2|STANDARD_ERROR_OF_MEAN|3.67||0.0498|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0498
73926182|NCT01480076|147379717|SUPERIORITY_OR_OTHER||difference of LS means|0.7|STANDARD_ERROR_OF_MEAN|5.95||0.9078|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9078
73926183|NCT02439320|147379762|SUPERIORITY||Odds Ratio (OR)|2.2|||<|0.001|TWO_SIDED|95.0|1.6|3.0|||Regression, Logistic|||||3.0|1.6|<0.001
73926184|NCT02439320|147379762|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|2.0|3.6|||Regression, Logistic|||||3.6|2.0|<0.001
73926185|NCT02439320|147379763|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
73926186|NCT02439320|147379763|SUPERIORITY||Odds Ratio, log|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
73926187|NCT02439320|147379764|SUPERIORITY||Odds Ratio, log|2.4|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
74029049|NCT02101411|147612376|OTHER|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Hazard Ratio (HR)|1.02|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Chi-squared|||The differences among the three PRU groups (\<85, 85-208,\>208) and ADEs were compared using the Chi-squared test.||||0.002
74029050|NCT01240811|147612408|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
73926188|NCT02439320|147379764|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.001|TWO_SIDED|95.0|1.9|3.3|||Regression, Logistic|||||3.3|1.9|<0.001
74029051|NCT01240811|147612408|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
73926189|NCT02439320|147379765|SUPERIORITY||Odds Ratio (OR)|1.7|||=|0.029|TWO_SIDED|95.0|1.1|2.8|||Regression, Logistic|||||2.8|1.1|=0.029
73926190|NCT02439320|147379765|SUPERIORITY||Odds Ratio (OR)|2.1|||=|0.002|TWO_SIDED|95.0|1.3|3.4|||Regression, Logistic|||||3.4|1.3|=0.002
73926191|NCT02439320|147379766|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5|||Regression, Logistic|||||0.5|0.3|<0.001
73926192|NCT02439320|147379766|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.2|0.4|||Regression, Logistic|||||0.4|0.2|<0.001
73926193|NCT02439320|147379767|SUPERIORITY||Odds Ratio, log|0.7||||0.12|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||||1.1|0.5|0.120
73926194|NCT02439320|147379767|SUPERIORITY||Odds Ratio (OR)|0.6||||0.035|TWO_SIDED|95.0|0.4|1.0|||Regression, Logistic|||||1.0|0.4|0.035
73926195|NCT02439320|147379769|SUPERIORITY||Odds Ratio (OR)|1.1||||0.386|TWO_SIDED|95.0|0.9|1.4|||Regression, Linear|||||1.4|0.9|0.386
73926196|NCT02439320|147379769|SUPERIORITY||Odds Ratio (OR)|1.1||||0.47|TWO_SIDED|95.0|0.9|1.4|||Regression, Linear|||||1.4|0.9|0.470
73926197|NCT02439320|147379770|SUPERIORITY||Odds Ratio (OR)|1.4||||0.006|TWO_SIDED|95.0|1.1|1.8|||Regression, Logistic|||||1.8|1.1|0.006
73926198|NCT02439320|147379770|SUPERIORITY||Odds Ratio (OR)|1.3||||0.037|TWO_SIDED|95.0|1.0|1.6|||Regression, Logistic|||||1.6|1.0|0.037
73926199|NCT02439320|147379771|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.5|2.4|||Regression, Logistic|||||2.4|1.5|<0.001
73926200|NCT02439320|147379771|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.4|2.2|||Regression, Logistic|||||02.2|1.4|<0.001
73926201|NCT02972632|147379775|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
73926202|NCT02972632|147379775|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
73926203|NCT02972632|147379776|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
73926204|NCT02972632|147379776|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
73926205|NCT02972632|147379777|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
73926206|NCT02972632|147379777|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
73926207|NCT02972632|147379778|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
73926208|NCT02972632|147379779|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
74029052|NCT01240811|147612409|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||Difference in paired change in Nugent score from baseline to 2 months||||0.08
74029053|NCT01240811|147612410|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||Change in quantity of H2O2 producing Lactobacilli species by qPCR||||0.46
74029054|NCT01240811|147612410|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||Change in quantity of Garnerella vaginalis species by qPCR||||0.62
74029055|NCT03990766|147612411|SUPERIORITY||Risk Difference (RD)|3.3|||||TWO_SIDED|95.0|-35.6|42.3||||||||42.3|-35.6|
74029056|NCT03990766|147612412|SUPERIORITY||Median Difference (Net)|1.0|||||TWO_SIDED|95.0|-3.0|5.0||||||||5|-3|
74087294|NCT01917968|147728517|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.20 (power 80%), 298 subjects (149 subjects per arm) are needed to detect non-inferiority with a margin of 10%.|Adjusted difference in percentages|-0.4|||||TWO_SIDED|90.0|-2.7|1.9|||||The propensity score adjusted difference in SAE rate of Uphold LITE transvaginal mesh (TVM) vs. NTR was estimated.|||1.9|-2.7|
73926209|NCT02972632|147379780|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
73926210|NCT02245841|147379782|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||< .001
73926211|NCT02245841|147379783|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||<0.001
73926212|NCT02245841|147379784|SUPERIORITY|||||||0.002|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||0.002
73926213|NCT02245841|147379785|SUPERIORITY|||||||0.05|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||0.050
73926214|NCT02245841|147379786|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||<0.001
73926215|NCT01835743|147379790|SUPERIORITY_OR_OTHER||||||<|5e-05|TWO_SIDED||||||Fisher Exact|||||||<0.00005
73926216|NCT01835743|147379791|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|t-test for two independent samples to compare the change in VAS scores across the evaluation period between the two procedure administration groups||||||<0.0001
73926217|NCT03054870|147379815|NON_INFERIORITY|The non-inferiority margin was determined from a separate study where 6 blinded readers read and re-read 75 Xe-133 planar ventilation imaging studies in 2 read sessions separated by a minimum of 4 weeks. The readers scored the 6 regions of the lung using the same ventilation scoring metric used in this study. Based on analysis of the read/re-read results, 60% was established as a suitable margin for establishing the non-inferiority of Technegas compared to Xe-133.|||||<|0.0141||||||P-value is one-sided; for testing non-inferiority the associated critical value for PA is provided by lower bound of the 97.18% confidence interval.|Mixed Models Analysis|Binary agreement scores between Technegas and Xe-133 ventilation scores by subject-lung region served as the dependent variable in the model.||PA between Technegas and Xe-133 from analysis of each of the 3 blinded readers' ventilation scores was subjected to the following test of null (H0) versus alternate hypotheses (HA): H0: PA \<= 60% versus HA: PA \> 60%. The original sample size of 240 subjects was based on 90% power and one-sided alpha=0.025. For the unplanned interim analysis of 200 subjects, testing for non-inferiority used one-sided alpha=0.0141 (critical value provided by lower bound of the 97.18% confidence interval).|Binary agreement scores were analyzed for each reader separately using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement (PA). For the study to be considered a success, the null hypothesis had to be rejected for at least 2 of the 3 blinded readers for the primary efficacy endpoint.|||<0.0141
73969066|NCT03637660|147476959|EQUIVALENCE|The alternative hypothesis was that the two treatment groups were unequal.|||||<|0.001||||||P-value was calculated based on 2-sided Pearson Chi-Square test. Difference in proportion was reported with the Wilson 95% CI|Chi-squared|||The number and proportion of participants who were compliant to the treatment, receiving all assigned doses within the assigned visit windows. The null hypothesis was no difference between two treatment groups.||||< 0.001
73969067|NCT03637660|147476961|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.05||||0.022|TWO_SIDED|90.0|-0.17|0.07||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning|||The number and proportion of participants with serological response by month 6 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.07|-0.17|0.022
74029057|NCT03990766|147612413|SUPERIORITY||Median Difference (Net)|-10.0|||||TWO_SIDED|95.0|-15.0|-4.0||||||The within-subject change in QOD-NS scores from baseline and 6 weeks was calculated for each individual patient. Then the median of all the patients' change in score for each cohort was calculated. Because these were within-subject changes in scores, the median difference values for each cohort do not necessarily correspond with simply subtracting the median change in score in the theophylline cohort from the median change in score in the placebo cohort.||-4|-15|
73926218|NCT03054870|147379816|NON_INFERIORITY|The non-inferiority margin was determined from a separate study where 6 blinded readers read and re-read 75 Xe-133 planar ventilation imaging studies in 2 read sessions separated by a minimum of 4 weeks. The readers scored the 6 regions of the lung using the same ventilation scoring metric used in this study. Based on analysis of the read/re-read results, 60% was established as a suitable margin for establishing the non-inferiority of Technegas compared to Xe-133.|||||<|0.0141||||||P-value is one-sided; for testing non-inferiority the associated critical value for PA is provided by lower bound of the 97.18% confidence interval.|Mixed Models Analysis|Binary agreement scores between Technegas and Xe-133 ventilation scores by subject-lung region served as the dependent variable in the model.||PA between Technegas and Xe-133 from analysis of each of the 3 blinded readers' ventilation scores was subjected to the following test of null (H0) versus alternate hypotheses (HA): H0: PA \<= 60% versus HA: PA \> 60%. The original sample size of 240 subjects was based on 90% power and one-sided alpha=0.025. For the unplanned interim analysis of 200 subjects, testing for non-inferiority used one-sided alpha=0.0141 (critical value provided by lower bound of the 97.18% confidence interval).|Binary agreement scores were analyzed for each reader separately using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement (PA). For the study to be considered a success, the null hypothesis had to be rejected for at least 2 of the 3 blinded readers for the primary efficacy endpoint.|||<0.0141
73926219|NCT03054870|147379817|OTHER||||||||||||||||||Estimates of inter-observer percent agreement were obtained as follows. For each reader-pair, binary agreement scores by subject and lung region were analyzed using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement.|||
73926220|NCT03054870|147379818|OTHER||||||||||||||||||For each pair of readers, by lung region estimates of kappa statistics and their corresponding 95% confidence intervals were generated from cross-tabulation frequencies of the readers' ventilation scores using SAS® PROC FREQ and the AGREE option.|||
73926221|NCT01154218|147379819|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.56|||||TWO_SIDED|90.0|91.49|108.33||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.33|91.49|
73926222|NCT01154218|147379819|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|106.93|||||TWO_SIDED|90.0|98.26|116.35||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||116.35|98.26|
73926223|NCT01154218|147379819|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|85.76|||||TWO_SIDED|90.0|78.88|93.25||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||93.25|78.88|
73926224|NCT01154218|147379820|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|99.6|||||TWO_SIDED|90.0|91.3|108.66||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.66|91.30|
73926225|NCT01154218|147379820|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|107.56|||||TWO_SIDED|90.0|98.58|117.35||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.35|98.58|
73926226|NCT01154218|147379820|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|85.52|||||TWO_SIDED|90.0|78.45|93.22||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||93.22|78.45|
73926227|NCT01154218|147379823|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|106.97|||||TWO_SIDED|90.0|96.55|118.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.51|96.55|
73926228|NCT01154218|147379823|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|111.32|||||TWO_SIDED|90.0|100.47|123.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||123.33|100.47|
73926229|NCT01154218|147379823|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|86.22|||||TWO_SIDED|90.0|77.89|95.43||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||95.43|77.89|
73969068|NCT03637660|147476961|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.037|TWO_SIDED|90.0|-0.22|0.09||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning|||The number and proportion of participants with serological response by month 6 among participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.09|-0.22|0.037
74029058|NCT03990766|147612414|SUPERIORITY||Median Difference (Net)|7.0|||||TWO_SIDED|95.0|-2.0|17.0||||||The within-subject change in ODOR scores from baseline and 6 weeks was calculated for each individual patient. Then the median of all the patients' change in score for each cohort was calculated. Because these were within-subject changes in scores, the median difference values for each cohort do not necessarily correspond with simply subtracting the median change in score in the theophylline cohort from the median change in score in the placebo cohort. We confirmed the reported results.||17|-2|
73862333|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83||||||90.0|3.2|10.45|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||10.45|3.20|
73926230|NCT01154218|147379826|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|100.03|||||TWO_SIDED|90.0|90.16|110.97||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.97|90.16|
73926231|NCT01154218|147379826|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.85|||||TWO_SIDED|90.0|98.11|120.77||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||120.77|98.11|
73926232|NCT01154218|147379826|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|74.87|||||TWO_SIDED|90.0|67.55|82.98||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||82.98|67.55|
73926233|NCT01154218|147379827|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|100.08|||||TWO_SIDED|90.0|90.46|110.73||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.73|90.46|
73926234|NCT01154218|147379827|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.47|||||TWO_SIDED|90.0|98.03|120.02||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||120.02|98.03|
73926235|NCT01154218|147379827|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|76.59|||||TWO_SIDED|90.0|69.23|84.74||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||84.74|69.23|
73926236|NCT01154218|147379828|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|102.11|||||TWO_SIDED|90.0|92.84|112.31||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||112.31|92.84|
73926237|NCT01154218|147379828|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.87|||||TWO_SIDED|90.0|98.98|119.75||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||119.75|98.98|
73926238|NCT01154218|147379828|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|71.94|||||TWO_SIDED|90.0|65.46|79.05||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||79.05|65.46|
73926239|NCT00108160|147379932|SUPERIORITY_OR_OTHER|||||||0.356||||||No adjustments were made for multiple comparisons.|Chi-squared|||Our null hypothesis was that no significant effect of mupirocin ointment (treatment) on S. aureus re-infection would be seen at 18 months compared with placebo ointment. Based on prior studies, we estimated that 198 participants would need to be enrolled assuming a 20% dropout rate; 84 participants per arm would be required to detect a 66% decrease in re-infection from 30% to 10% with a significance level alpha of 0.05 and a power of 0.9.||||0.356
73926240|NCT01331148|147379980|OTHER|||||||0.0507|||||||t-test, 2 sided|||Due to the longitudinal nature of the data and presence of missing values, repeated measures analyses were conducted using the MIXED procedure in SAS. Spearman's rank correlation coefficient was used to quantify the relationship between PedsQL scores with 25OHD concentrations and pain days. Two-way analysis of variance models compared PedsQL scores between treatment groups over time.||||0.0507
73969069|NCT03637660|147476962|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.05||||0.002|TWO_SIDED|90.0|-0.14|0.04||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by Month 12 and the 95% confidence interval (CI) were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.04|-0.14|0.002
74029059|NCT01543490|147612415|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was 2-sided and performed using a significance (alpha) level of 0.05.|Risk Difference (RD)|8.5|STANDARD_ERROR_OF_MEAN|4.03||0.0354|TWO_SIDED|95.0|0.2|16.6||The p-value was from a 2-sided Fisher's exact test.|Fisher Exact|The point estimate of treatment effect (ISV-305 compared with Vehicle) was reported using Fisher's exact test.|The risk difference was obtained by taking the difference in proportions (ISV-305 minus Vehicle). A 2-sided exact unconditional 95% confidence interval (CI) was calculated.|||16.6|0.2|0.0354
73926241|NCT00004888|147380023|SUPERIORITY_OR_OTHER||Overall Response Rate|0.474|||||TWO_SIDED|95.0|0.31|0.642||||||||0.642|0.31|
73926242|NCT00004888|147380023|SUPERIORITY_OR_OTHER||Overall Response Rate|0.457|||||TWO_SIDED|95.0|0.309|0.61||||||||0.61|0.309|
73926243|NCT02174848|147380045|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone.||||0.0500
73926244|NCT02174848|147380045|SUPERIORITY|||||||0.9781|||||||t-test, 2 sided|||This comparison is for the extension study, during which patients in both groups received deferiprone.||||0.9781
73926245|NCT02174848|147380046|SUPERIORITY|||||||0.0206|||||||paired t-test|||||||0.0206
73926246|NCT02174848|147380047|SUPERIORITY|||||||0.2684|||||||paired t-test|||||||0.2684
73926247|NCT02174848|147380048|SUPERIORITY|||||||0.0821|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone||||0.0821
73926248|NCT02174848|147380048|SUPERIORITY|||||||0.5885|||||||t-test, 2 sided|||For the placebo-DFP group, the comparison is of the scores at the start vs. the end of the extension study; for the DFP-DFP group, the comparison is of the scores at the start vs. the end of the initial study||||0.5885
73926249|NCT02174848|147380049|SUPERIORITY|||||||0.3306|||||||t-test, 2 sided|||||||0.3306
73969070|NCT03637660|147476963|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.011|TWO_SIDED|90.0|-0.18|0.05||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-infected participants by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by month 12 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.05|-0.18|0.011
73969071|NCT03637660|147476963|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.03||||0.064|TWO_SIDED|90.0|-0.18|0.11||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by month 12 amont participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.11|-0.18|0.064
73969072|NCT05603143|147476991|OTHER|||||||0.3161|||||||Log Rank|||||||0.3161
73969073|NCT05603143|147476995|OTHER|||||||0.3219|||||||Log Rank|||||||0.3219
74029060|NCT01543490|147612416|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoint was 2-sided and performed using a significance (alpha) level of 0.05, and missing data imputed using the LOCF approach.|Risk Difference (RD)|7.1|STANDARD_ERROR_OF_MEAN|4.07||0.1036|TWO_SIDED|95.0|-1.3|15.0||The p-value was from a 2-sided Fisher's exact test.|Fisher Exact|The point estimate of treatment effect (ISV-305 compared with Vehicle) was reported using Fisher's exact test.|The risk difference was obtained by taking the difference in proportions (ISV-305 minus Vehicle). A 2-sided exact unconditional 95% CI was calculated.|||15.0|-1.3|0.1036
74029061|NCT03918642|147612424|SUPERIORITY||Mean Difference (Net)|-1.59|||<|0.001|TWO_SIDED|95.0|-2.35|-0.83|||Mixed Models Analysis|||||-0.83|-2.35|<0.001
74029062|NCT03918642|147612425|SUPERIORITY||Mean Difference (Net)|-1.01||||0.01|TWO_SIDED|95.0|-1.78|-0.24|||Mixed Models Analysis|||||-0.24|-1.78|0.01
73926250|NCT00644969|147380076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.74||||0.0457|TWO_SIDED|95.0|1.03|21.78|||Regression, Logistic|||||21.78|1.03|0.0457
73926251|NCT00644969|147380077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18||||0.0901|TWO_SIDED|95.0|0.75|50.71|||Regression, Logistic|||||50.71|0.75|0.0901
73926252|NCT00644969|147380078|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.1524|TWO_SIDED|95.0|0.82|3.68|||Regression, Logistic|||Week 12||3.68|0.82|0.1524
73926253|NCT00644969|147380078|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9235|TWO_SIDED|95.0|0.45|2.05|||Regression, Logistic|||Week 24||2.05|0.45|0.9235
73926254|NCT00644969|147380079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.0077|TWO_SIDED|95.0|-6.32|-0.99|||ANCOVA||Least squares mean difference|Week 12 treatment difference||-0.99|-6.32|0.0077
73926255|NCT00644969|147380079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.9022|TWO_SIDED|95.0|-3.99|3.52|||ANCOVA||Least squares mean difference|Week 24 treatment difference||3.52|-3.99|0.9022
73926256|NCT03244865|147380080|NON_INFERIORITY|Non-inferiority will be verified if the RMSE between the two systems is within 7 BPM. A complete power analysis was not included as this is a pilot study.|||||<|0.1||||||Pilot Study|t-test, 2 sided|||There is only one ARM in the study. Standard monitoring and LaborView monitoring will be collected simultaneously and analyzed.||||<.1
73969074|NCT05603143|147476996|OTHER||Hazard Ratio (HR)|1.496||||0.6568|TWO_SIDED|95.0|0.25|8.952|||Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.|||8.952|0.250|0.6568
74029063|NCT03918642|147612426|SUPERIORITY||Mean Difference (Net)|0.28|||<|0.001|TWO_SIDED|95.0|0.12|0.45|||Mixed Models Analysis|||||0.45|0.12|<0.001
74029064|NCT03918642|147612427|SUPERIORITY||Mean Difference (Net)|-1.42||||0.14|TWO_SIDED|95.0|-3.3|0.46|||Mixed Models Analysis|||||0.46|-3.30|0.14
74029065|NCT03918642|147612428|SUPERIORITY||Mean Difference (Net)|0.21||||0.85|TWO_SIDED|95.0|-1.99|2.42|||Mixed Models Analysis|||||2.42|-1.99|0.85
74029066|NCT03918642|147612429|SUPERIORITY||Mean Difference (Net)|-3.06||||0.03|TWO_SIDED|95.0|-5.88|-0.25|||Mixed Models Analysis|||||-0.25|-5.88|0.03
74029067|NCT03918642|147612430|SUPERIORITY||Mean Difference (Net)|-2.39||||0.02|TWO_SIDED|95.0|-4.33|-0.45|||Mixed Models Analysis|||||-0.45|-4.33|0.02
73926257|NCT00666757|147380088|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the remission rates at 12 week endpoint between treatment groups.||||0.26
73926258|NCT00666757|147380089|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-week endpoint.||||0.07
73926259|NCT00666757|147380090|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). Repeated Measures Analysis. The analysis will contrast the remission remission rates at 12-week endpoint.||||0.03
73926260|NCT00666757|147380091|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.||||0.09
73926261|NCT00666757|147380092|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.||||0.001
73926262|NCT00666757|147380093|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.002
73926263|NCT00666757|147380094|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.001
73926264|NCT00666757|147380095|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.003
73926265|NCT00666757|147380096|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.01
73926266|NCT00666757|147380097|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.02
73926267|NCT00666757|147380098|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.20
73926268|NCT00666757|147380099|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Only those patients who had at least moderate pain at baseline (defined as baseline BPI Average 24-Hour Pain Score greater than or equal to 3). Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.03
73926269|NCT00666757|147380100|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.03
73926270|NCT00666757|147380101|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.002
73926271|NCT00666757|147380102|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.01
73926272|NCT00666757|147380103|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||Between group P-value|ANCOVA|||||||0.07
73926273|NCT00666757|147380104|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||Between group P-value|ANCOVA|||||||0.34
73926274|NCT00666757|147380105|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.02
73926275|NCT00666757|147380106|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.01
73926276|NCT00666757|147380107|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.97
73926277|NCT00666757|147380108|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.32
73926278|NCT00666757|147380109|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||Between group P-value|ANCOVA|||Transformed absolute score||||0.12
73926279|NCT00666757|147380110|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Between group P-value|ANCOVA|||Transformed Absolute Score||||0.16
73926280|NCT00666757|147380111|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.002
73926281|NCT00666757|147380112|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.53
73926282|NCT00952341|147380124|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.007
73926283|NCT00952341|147380125|SUPERIORITY_OR_OTHER|||||||0.942||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.942
73926284|NCT00952341|147380126|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.001
73926285|NCT00952341|147380127|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy."||||0.003
73926286|NCT00952341|147380128|SUPERIORITY_OR_OTHER|||||||0.882||95.0|||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.||||0.882
73926287|NCT00952341|147380129|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.||||0.001
73926288|NCT01589445|147380148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.06|STANDARD_DEVIATION|39.47|<|0.161||95.0|-88.0|118.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TC||118|-88.0|<0.161
73926289|NCT01589445|147380148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.66|STANDARD_DEVIATION|143.22|<|0.913|TWO_SIDED|95.0|-397.0|976.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TG||976|-397.0|<0.913
73926290|NCT01589445|147380148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|9.59|<|0.322|TWO_SIDED|95.0|-35.0|19.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HDL||19.0|-35.0|<0.322
73926291|NCT01589445|147380148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.62|STANDARD_DEVIATION|32.05|<|0.21|TWO_SIDED|95.0|-113.8|76.2||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||LDL||76.2|-113.8|<0.210
73926292|NCT01589445|147380149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_DEVIATION|2.41|<|0.05|TWO_SIDED|95.0|-7.9|8.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, Multiple Logistic Regression (MLR), OR, Pearson Correlation)|ANOVA||The group 001 was divided according to Pro12Pro and Pro12Ala groups.There was no Ala12Ala group.These two groups were compared also in accordance with all parameters (glycemic levels, insulin levels, lipid profiles, BMI).|Change from Baseline in FSG at 3rd month||8.0|-7.9|<0.05
73926293|NCT01589445|147380150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|STANDARD_DEVIATION|1.07|>|0.05|TWO_SIDED|95.0|-4.4|2.4||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||||2.4|-4.4|>0.05
73926294|NCT01589445|147380151|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.12|<|0.001|TWO_SIDED|95.0|-0.4|0.27||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||||0.27|-0.40|<0.001
73926295|NCT01589445|147380151|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|STANDARD_DEVIATION|4.25|<|0.004|TWO_SIDED|95.0|-14.12|15.52||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA IR||15.52|-14.12|<0.004
73926296|NCT01589445|147380152|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.79|STANDARD_DEVIATION|84.46|<|0.808|TWO_SIDED|95.0|-346.4|328.1||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA B||328.10|-346.40|<0.808
73969075|NCT05603143|147476997|OTHER||Hazard Ratio (HR)|2.99||||0.319|TWO_SIDED|95.0|0.311|28.74|||Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.|||28.740|0.311|0.3190
73969076|NCT05603143|147476998|OTHER|||||||0.3161|||||||Log Rank|||||||0.3161
73969077|NCT05603143|147476999|OTHER||Hazard Ratio (HR)|1.425||||0.0859|TWO_SIDED|95.0|0.961|2.112||P-value was based on stratified Log-rank test with randomization stratification factors as the strata.|Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factors as covariates.|||2.112|0.961|0.0859
74087295|NCT02449473|147728547|SUPERIORITY|The model included treatment group as fixed effect and baseline log-transformed airway submucosal eosinophils as a continuous covariate. No interaction terms were included in the model. The analysis was performed using log-transformed data. All group comparisons from analysis of covariance (ANCOVA) model were based on Type III sums of squares.|Least square (LS) geometric mean ratio|1.43||||0.3862|TWO_SIDED|95.0|0.63|3.27|||ANCOVA|||Comparison of change from baseline, expressed as a ratio, in airway submucosal eosinophils; Tralo 300 mg Q2W vs placebo. The null hypothesis was that the change in airway submucosal eosinophils at Week 12 on tralokinumab was equal to the corresponding change on placebo.||3.27|0.63|0.3862
73926297|NCT01589445|147380152|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.53|STANDARD_DEVIATION|54.0|<|0.025|TWO_SIDED|95.0|-148.7|180.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA S||180|-148.70|<0.025
73926298|NCT01589445|147380153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|STANDARD_DEVIATION|10.2|<|0.039|TWO_SIDED|95.0|-27.04|26.52||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||FSI||26.52|-27.04|<0.039
73926299|NCT01451775|147380164|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|84.04|STANDARD_DEVIATION|6.4|||TWO_SIDED|90.0|80.856|87.344|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation.|||87.344|80.856|
73926300|NCT01451775|147380164|NON_INFERIORITY_OR_EQUIVALENCE|This is an analysis of dose proportionality|Slope|0.9367|STANDARD_ERROR_OF_MEAN|0.0178|||TWO_SIDED|95.0|0.8988|0.9746||Does proportionality would be assumed if the 95% confidence interval includes one.|ANCOVA|ANCOVA with logarithm of the dose fitted as a continuous covariate and sequence, subjects within sequence, period included as categorical variables.||||0.9746|0.8988|
73926301|NCT01451775|147380165|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|63.22|STANDARD_DEVIATION|18.1|||TWO_SIDED|90.0|56.736|70.439|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation.|||70.439|56.736|
73969078|NCT05603143|147477000|OTHER||Treatment Difference (vs Placebo)|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.83|-0.33|||MMRM||Least-squares mean (SE), 95% CI and P value were from MMRM with baseline viral load and randomization strata as covariates.|||-0.33|-0.83|< 0.0001
73969079|NCT03097549|147477007|SUPERIORITY||Estimated difference|-3.1||||0.001|TWO_SIDED|95.0|-4.8|-1.3|||Mixed Models Analysis|||Comparison of mean scores using a linear mixed model, incorporating baseline data and accounting for all available data. Sample size calculation: We anticipated ICIQ-UI SF improvements of 2.5 points in the treatment group and 0.9 points in the information group. Detecting this difference with 80% power, a two-sided test, and a significance level of P\<.05 would require a sample size of 49 in each group. With an expected drop-out rate of 20%, we needed approximately 60 participants in each group.||-1.3|-4.8|0.001
73969080|NCT03097549|147477008|SUPERIORITY||Estimated difference|-6.3||||0.004|TWO_SIDED|95.0|-10.5|-2.1|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-2.1|-10.5|0.004
73969081|NCT03097549|147477009|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: There is no difference in the number of urinary leakage episodes between the treatment app users and the information app users at follow-up.~ITT analysis. Missing data: 5 participants in the treatment group and 2 participants in the information group had a missing value at follow-up, and for those, the difference was set to 0 (ie, no change)."||||<0.001
73862334|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.02||||||90.0|1.4|8.65|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.65|1.40|
73862335|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.72||||||90.0|1.09|8.34|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.34|1.09|
73862336|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.05||||||90.0|0.43|7.67|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||7.67|0.43|
73862337|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.36||||||90.0|2.73|9.98|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||9.98|2.73|
73862338|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.08||||||90.0|1.45|8.7|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.70|1.45|
73862339|NCT00853840|147270499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||||90.0|-1.74|5.51|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||5.51|-1.74|
73926302|NCT01451775|147380165|NON_INFERIORITY_OR_EQUIVALENCE|This is an analysis of dose proportionality|Slope|0.9065|STANDARD_DEVIATION|0.0495|||TWO_SIDED|95.0|0.8011|1.012||Does proportionality would be assumed if the 95% confidence interval includes one.|ANCOVA|ANCOVA with logarithm of the dose fitted as a continuous covariate and sequence, subjects within sequence, period included as categorical variables.||||1.0120|0.8011|
73926303|NCT02016482|147380183|SUPERIORITY_OR_OTHER||Difference in percentage|43.2|||<|0.001|TWO_SIDED|95.0|32.8|53.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||For US regulatory purposes, ranked first secondary endpoint.||53.6|32.8|< 0.001
73926304|NCT02016482|147380184|SUPERIORITY_OR_OTHER||Difference in percentage|42.0|||<|0.001|TWO_SIDED|95.0|30.8|53.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked sixth secondary endpoint. For US regulatory purposes, this was the primary endpoint.||53.2|30.8|< 0.001
73862340|NCT00966719|147270503|OTHER||Risk Ratio (RR)|0.84||||0.4|TWO_SIDED|95.0|0.56|1.24|||Fisher Exact|||||1.24|0.56|0.40
74087296|NCT02449473|147728548|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A restricted maximum likelihood (REML) approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.21||||0.0546|TWO_SIDED|95.0|1.0|1.48|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood eosinophil count; Tralo 300 mg Q2W vs placebo.||1.48|1.00|0.0546
73862341|NCT00966719|147270504|OTHER||Risk Ratio (RR)|1.15||||1|TWO_SIDED|95.0|0.44|3.02|||Fisher Exact|||||3.02|0.44|1
73862342|NCT00966719|147270505|OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.91|1.1|||Fisher Exact|||||1.10|0.91|1
73862343|NCT00966719|147270506|OTHER||Risk Ratio (RR)|1.03||||0.78|TWO_SIDED|95.0|0.85|1.26|||Fisher Exact|||||1.26|0.85|0.78
73862344|NCT00966719|147270507|OTHER||Risk Ratio (RR)|2.94||||0.32|TWO_SIDED|95.0|0.32|27.3|||Fisher Exact|||||27.30|0.32|0.32
73862345|NCT00966719|147270508|OTHER||Risk Ratio (RR)|1.5||||0.09|TWO_SIDED|95.0|0.95|2.38|||Fisher Exact|||||2.38|0.95|0.09
73862346|NCT00966719|147270509|OTHER||Risk Ratio (RR)|1.03||||0.77|TWO_SIDED|95.0|0.83|1.27|||Fisher Exact|||||1.27|0.83|0.77
73862347|NCT00966719|147270510|OTHER||Risk Ratio (RR)|1.36||||0.6|TWO_SIDED|95.0|0.58|3.15|||Fisher Exact|||||3.15|0.58|0.6
73862348|NCT01710527|147270511|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed Cmax fell within the acceptance range of 80 to 125%.|Ratio (%)|96.85||||0.3125|TWO_SIDED|90.0|91.86|102.11|||ANOVA||Analysis was performed on log transformed geometric least square means.|||102.11|91.86|0.3125
73862349|NCT01710527|147270512|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-t fell within the acceptance range of 80 to 125%.|Ratio (%)|102.52||||0.2701|TWO_SIDED|90.0|98.74|106.45|||ANOVA|||Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-t||106.45|98.74|0.2701
73862350|NCT01710527|147270512|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-infinity fell within the acceptance range of 80 to 125%.|Ratio (%)|102.44||||0.2702|TWO_SIDED|90.0|98.78|106.23|||ANOVA||Analysis was performed on log transformed geometric least square means.|Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-infinity.||106.23|98.78|0.2702
73926305|NCT02016482|147380185|SUPERIORITY_OR_OTHER||LS Mean|-44.8|||<|0.001|TWO_SIDED|95.0|-53.5|-36.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked first secondary endpoint. For US regulatory purposes, ranked second secondary endpoint.||-36.0|-53.5|< 0.001
73926306|NCT02016482|147380186|SUPERIORITY_OR_OTHER||Difference in percentage|6.6||||0.008|TWO_SIDED|95.0|1.8|11.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked second secondary endpoint. For US regulatory purposes, ranked third secondary endpoint.||11.3|1.8|0.008
74029068|NCT03918642|147612431|SUPERIORITY||Mean Difference (Net)|-2.49||||0.006|TWO_SIDED|95.0|-4.3|-0.68|||Mixed Models Analysis|||||-0.68|-4.30|0.006
73926307|NCT02016482|147380187|SUPERIORITY_OR_OTHER||LS Mean Percent Change|-2.6|||<|0.001|TWO_SIDED|95.0|-3.3|-2.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked third secondary endpoint. For US regulatory purposes, ranked fourth secondary endpoint.||-2.0|-3.3|< 0.001
73926308|NCT02016482|147380188|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.001|TWO_SIDED|95.0|-3.6|-2.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked fourth secondary endpoint. For US regulatory purposes, ranked fifth secondary endpoint.||-2.2|-3.6|< 0.001
73926309|NCT02016482|147380189|SUPERIORITY_OR_OTHER||Difference in percentage|57.9||||0.002|TWO_SIDED|95.0|33.8|82.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked fifth secondary endpoint. For US regulatory purposes, ranked sixth secondary endpoint.||82.0|33.8|0.002
73926310|NCT02016482|147380190|SUPERIORITY_OR_OTHER||Difference in percentage|43.3|||<|0.001|TWO_SIDED|95.0|31.3|55.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||55.2|31.3|< 0.001
73926311|NCT02016482|147380191|SUPERIORITY_OR_OTHER||Difference in percentage|44.8|||<|0.001|TWO_SIDED|95.0|33.2|56.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||56.5|33.2|< 0.001
73926312|NCT02016482|147380192|SUPERIORITY_OR_OTHER||Difference in percentage|18.6|||<|0.001|TWO_SIDED|95.0|10.6|26.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||26.6|10.6|< 0.001
73926313|NCT02016482|147380193|SUPERIORITY_OR_OTHER||Difference in percentage|36.0|||<|0.001|TWO_SIDED|95.0|25.0|46.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||46.9|25.0|< 0.001
73926314|NCT02016482|147380194|SUPERIORITY_OR_OTHER||Difference in percentage|13.3|||<|0.001|TWO_SIDED|95.0|6.5|20.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||20.0|6.5|<0.001
73926315|NCT02016482|147380195|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|||<|0.001|TWO_SIDED|95.0|-4.3|-2.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-2.8|-4.3|< 0.001
73926316|NCT02016482|147380196|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.9|||<|0.001|TWO_SIDED|95.0|-46.9|-30.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-30.8|-46.9|< 0.001
73926317|NCT02016482|147380197|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.6|||<|0.001|TWO_SIDED|95.0|-33.5|-23.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-23.7|-33.5|< 0.001
74029069|NCT03918642|147612432|SUPERIORITY||Mean Difference (Net)|-1.95||||0.11|TWO_SIDED|95.0|-4.34|0.45|||Mixed Models Analysis|||||0.45|-4.34|0.11
73926318|NCT02016482|147380198|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.1|||<|0.001|TWO_SIDED|95.0|-58.3|-41.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-41.9|-58.3|< 0.001
73926319|NCT02016482|147380199|SUPERIORITY_OR_OTHER||Difference in percentage|7.4||||0.004|TWO_SIDED|95.0|2.4|12.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||12.4|2.4|0.004
73926320|NCT02016482|147380200|SUPERIORITY_OR_OTHER||Difference in percentage|18.5|||<|0.001|TWO_SIDED|95.0|10.1|26.8||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||26.8|10.1|< 0.001
73926321|NCT02016482|147380201|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|||<|0.001|TWO_SIDED|95.0|-3.1|-1.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-1.9|-3.1|< 0.001
73926322|NCT02016482|147380202|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.2|||<|0.001|TWO_SIDED|95.0|-50.0|-30.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-30.4|-50.0|< 0.001
73926323|NCT02016482|147380203|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.5|||<|0.001|TWO_SIDED|95.0|-23.6|-15.3||Across all strata, P values were calculated from ANCOVA with stratum, Baseline value, and treatment in the model.|ANCOVA|||||-15.3|-23.6|< 0.001
73926324|NCT02016482|147380204|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.1|||<|0.001|TWO_SIDED|95.0|-10.0|-6.1||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-6.1|-10.0|< 0.001
73926325|NCT02016482|147380205|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.2|||<|0.001|TWO_SIDED|95.0|-87.3|-55.0||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-55.0|-87.3|< 0.001
74029070|NCT03918642|147612433|SUPERIORITY||Mean Difference (Net)|-4.39||||0.03|TWO_SIDED|95.0|-8.44|-0.34|||Mixed Models Analysis|||||-0.34|-8.44|0.03
74029071|NCT03918642|147612434|SUPERIORITY||Mean Difference (Net)|-3.76||||0.07|TWO_SIDED|95.0|-7.83|0.32|||Mixed Models Analysis|||||0.32|-7.83|0.07
74029072|NCT03918642|147612435|SUPERIORITY||Mean Difference (Net)|1.23||||0.005|TWO_SIDED|95.0|0.36|2.1|||Mixed Models Analysis|||||2.10|0.36|0.005
74029073|NCT03918642|147612436|SUPERIORITY||Mean Difference (Net)|0.95||||0.17|TWO_SIDED|95.0|-0.4|2.29|||Mixed Models Analysis|||||2.29|-0.40|0.17
73926326|NCT02016482|147380206|SUPERIORITY_OR_OTHER||Difference in percentage|51.1|||<|0.001|TWO_SIDED|95.0|38.6|63.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 75||63.5|38.6|< 0.001
74029074|NCT03918642|147612437|SUPERIORITY||Mean Difference (Net)|-1.85||||0.11|TWO_SIDED|95.0|-4.14|0.44|||Mixed Models Analysis|||||0.44|-4.14|0.11
74029075|NCT03918642|147612438|SUPERIORITY||Mean Difference (Net)|-2.57||||0.11|TWO_SIDED|95.0|-5.73|0.6|||Mixed Models Analysis|||||0.60|-5.73|0.11
74029076|NCT03918642|147612439|SUPERIORITY||Mean Difference (Net)|-0.78||||0.33|TWO_SIDED|95.0|-2.33|0.78|||Mixed Models Analysis|||||0.78|-2.33|0.33
74029077|NCT03918642|147612440|SUPERIORITY||Mean Difference (Net)|-0.3||||0.69|TWO_SIDED|95.0|-1.74|1.14|||Mixed Models Analysis|||||1.14|-1.74|0.69
74029078|NCT03918642|147612441|SUPERIORITY||Mean Difference (Net)|1.46|||<|0.001|TWO_SIDED|95.0|0.77|2.15|||Mixed Models Analysis|||||2.15|0.77|<0.001
74029079|NCT03918642|147612442|SUPERIORITY||Mean Difference (Net)|1.24|||<|0.001|TWO_SIDED|95.0|0.62|1.86|||Mixed Models Analysis|||||1.86|0.62|<0.001
74029080|NCT03918642|147612443|SUPERIORITY||Odds Ratio (OR)|21.54|||<|0.001|TWO_SIDED|95.0|4.66|99.56|||Mixed Models Analysis|||||99.56|4.66|<0.001
74029081|NCT03918642|147612444|SUPERIORITY||Odds Ratio (OR)|7.24||||0.006|TWO_SIDED|95.0|1.74|30.06|||Mixed Models Analysis|||||30.06|1.74|0.006
73926327|NCT02016482|147380206|SUPERIORITY_OR_OTHER||Difference in percentage|52.5|||<|0.001|TWO_SIDED|95.0|39.9|65.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 50||65.0|39.9|< 0.001
73926328|NCT02016482|147380206|SUPERIORITY_OR_OTHER||Difference in percentage|40.9|||<|0.001|TWO_SIDED|95.0|29.0|52.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 90||52.9|29.0|< 0.001
73926329|NCT02016482|147380206|SUPERIORITY_OR_OTHER||Difference in percentage|26.4|||<|0.001|TWO_SIDED|95.0|15.8|36.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 100||36.9|15.8|< 0.001
73926330|NCT02016482|147380207|SUPERIORITY_OR_OTHER||Difference in percentage|52.2|||<|0.001|TWO_SIDED|95.0|40.8|63.7||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||63.7|40.8|< 0.001
73926331|NCT02016482|147380208|SUPERIORITY_OR_OTHER||Difference in percentage|24.8|||<|0.001|TWO_SIDED|95.0|15.3|34.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||34.3|15.3|< 0.001
73926332|NCT02016482|147380209|SUPERIORITY_OR_OTHER||Difference in percentage|90.4|||<|0.001|TWO_SIDED|95.0|72.5|108.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||108.3|72.5|< 0.001
73926333|NCT02016482|147380210|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.1|||<|0.001|TWO_SIDED|95.0|-13.9|-8.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-8.4|-13.9|< 0.001
73926334|NCT02016482|147380211|SUPERIORITY_OR_OTHER||LS Mean Difference|-80.6|||<|0.001|TWO_SIDED|95.0|-97.9|-63.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-63.3|-97.9|< 0.001
73926335|NCT02016482|147380212|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.9|||<|0.001|TWO_SIDED|95.0|-64.0|-37.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-37.8|-64.0|< 0.001
73926336|NCT02016482|147380213|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.7|||<|0.001|TWO_SIDED|95.0|-73.1|-42.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-42.4|-73.1|< 0.001
73926337|NCT02016482|147380214|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.1|-0.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-0.7|-1.1|< 0.001
73926338|NCT02016482|147380215|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.7|||<|0.001|TWO_SIDED|95.0|-33.9|-21.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-21.6|-33.9|< 0.001
73926339|NCT02016482|147380216|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-7.8|-4.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-4.5|-7.8|< 0.001
73926340|NCT02016482|147380217|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||<|0.001|TWO_SIDED|95.0|7.1|24.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||DLQI = 0||24.3|7.1|< 0.001
73926341|NCT02016482|147380217|SUPERIORITY_OR_OTHER||Difference in percentage|27.1|||<|0.001|TWO_SIDED|95.0|16.7|37.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||DLQI = 0/1||37.4|16.7|< 0.001
73926342|NCT02016482|147380218|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.416|TWO_SIDED|95.0|-1.0|2.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Absenteeism||2.5|-1.0|0.416
73926343|NCT02016482|147380218|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.3|||<|0.001|TWO_SIDED|95.0|-22.9|-11.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Presenteeism||-11.6|-22.9|< 0.001
73862351|NCT01688921|147270576|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.88|1.12||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.12|0.88|
73862352|NCT01688921|147270577|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.96|1.21||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.21|0.96|
73862353|NCT01688921|147270578|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.83|1.06||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.06|0.83|
73862354|NCT01688921|147270579|NON_INFERIORITY_OR_EQUIVALENCE|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points.|Seroconversion Rate Difference|0.8|||||TWO_SIDED|95.0|-4.8|6.5||||||For a sample size of 550 per group each test has an individual power of \> 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||6.5|-4.8|
73862355|NCT01688921|147270580|NON_INFERIORITY_OR_EQUIVALENCE|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates(rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points|Seroconversion Rate Difference|1.3|||||TWO_SIDED|95.0|-4.5|7.1||||||For a sample size of 550 per group each test has an individual power of \> 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||7.1|-4.5|
73862356|NCT01688921|147270581|NON_INFERIORITY_OR_EQUIVALENCE|"Seroconversion rate was defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer.~The upper-bound of the two-sided 95% CI on the difference in seroconversion rates for the A/H1N1, A/H3N2, and B strains did not exceed 10 percentage points (6.5, 7.1, and 5.9 respectively)."|Seroconversion Rate Difference|0.3|||||TWO_SIDED|95.0|-5.2|5.9||||||For a sample size of 550 per group each test has an individual power of \> 91% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||5.9|-5.2|
73862357|NCT01688921|147270582|NON_INFERIORITY_OR_EQUIVALENCE|Immediate adverse events were reported within 30 minutes of receiving the vaccination; therefore, they are all considered related to study treatment.|||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73862358|NCT01688921|147270583|NON_INFERIORITY_OR_EQUIVALENCE|The safety population included subjects who received the vaccination and for whom follow-up data were available for a specific safety analysis. Therefore, the denominators for different safety tables vary, depending on the availability of the data.|||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73862359|NCT02358044|147270586|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||<|0.001|TWO_SIDED|95.0|3.6|15.3|||Miettinen & Nurminen Method|||"Primary Analysis Approach: Non-Inferiority~Analyses of the percentage of participants achieving SVR12 was conducted using the Miettinen \& Nurminen (M\&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided."||15.3|3.6|<0.001
73926344|NCT02016482|147380218|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.2|||<|0.001|TWO_SIDED|95.0|-21.0|-9.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Overall work impairment||-9.3|-21.0|< 0.001
73926345|NCT02016482|147380218|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.4|||<|0.001|TWO_SIDED|95.0|-27.3|-15.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Activity impairment||-15.4|-27.3|< 0.001
73926346|NCT02016482|147380219|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|||<|0.001|TWO_SIDED|95.0|0.1|0.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||0.2|0.1|< 0.001
73926347|NCT02016482|147380220|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5||||0.012|TWO_SIDED|95.0|1.2|9.8||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||9.8|1.2|0.012
74029082|NCT03918642|147612445|SUPERIORITY||Odds Ratio (OR)|11.77||||0.002|TWO_SIDED|95.0|2.38|58.25|||Mixed Models Analysis|||||58.25|2.38|0.002
74029083|NCT03918642|147612446|SUPERIORITY||Odds Ratio (OR)|6.58||||0.05|TWO_SIDED|95.0|0.99|43.67|||Mixed Models Analysis|||||43.67|0.99|0.05
74029084|NCT03918642|147612447|SUPERIORITY||Odds Ratio (OR)|13.93||||0.06|TWO_SIDED|95.0|0.86|225.44|||Mixed Models Analysis|||||225.44|0.86|0.06
74029085|NCT03918642|147612448|SUPERIORITY||Odds Ratio (OR)|5.61||||0.22|TWO_SIDED|95.0|0.35|89.3|||Mixed Models Analysis|||||89.30|0.35|0.22
74029086|NCT03825042|147612449|SUPERIORITY||Mean Difference (Final Values)|-21.01||||0|TWO_SIDED|95.0|-26.8|-15.2|||ANCOVA|||||-15.20|-26.80|0.0000
74029087|NCT03825042|147612450|SUPERIORITY||Mean Difference (Final Values)|-6.08||||0|TWO_SIDED|95.0|-8.45|-3.61|||ANCOVA|||||-3.61|-8.45|0.0000
74029088|NCT03825042|147612451|SUPERIORITY||Mean Difference (Final Values)|-14.56||||0|TWO_SIDED|95.0|-20.02|-9.11|||ANCOVA|||||-9.11|-20.02|0.0000
74029089|NCT02316470|147612452|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74029090|NCT02316470|147612452|SUPERIORITY_OR_OTHER|||||||0.0261|||||||Cochran-Mantel-Haenszel|||||||0.0261
74029091|NCT02316470|147612452|SUPERIORITY_OR_OTHER|||||||0.0364|||||||Cochran-Mantel-Haenszel|||||||0.0364
74029092|NCT02316470|147612452|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74029093|NCT02316470|147612452|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74029094|NCT02316470|147612452|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74029095|NCT02316470|147612452|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74029096|NCT02316470|147612453|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was \<0.0001 at each time point (Day 14, 28, 35, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
74029097|NCT02316470|147612454|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was \<0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
74029098|NCT02316470|147612455|SUPERIORITY_OR_OTHER||||||<|0.0001||||||the p-value was \<0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
74029099|NCT05057988|147612509|OTHER|paired T test|Mean Difference (Net)|1.04|STANDARD_DEVIATION|1.8|<|0.001|TWO_SIDED|95.0|0.53|1.55|||t-test, 2 sided|||||1.55|0.53|<.001
74029100|NCT05057988|147612510|OTHER|Paired T test|Mean Difference (Net)|0.98|STANDARD_DEVIATION|8.17||0.208|TWO_SIDED|95.0|-1.42|3.37|||t-test, 2 sided|||||3.37|-1.42|.208
74029101|NCT05057988|147612511|OTHER|Paired T test|Mean Difference (Net)|0.86|STANDARD_DEVIATION|1.2|<|0.001|TWO_SIDED|95.0|0.52|1.2|||t-test, 2 sided|||||1.20|0.52|<.001
74029102|NCT05057988|147612512|OTHER|Paired t test|Mean Difference (Net)|0.81|STANDARD_DEVIATION|5.65||0.328|TWO_SIDED|95.0|-0.84|2.47|||t-test, 1 sided|||||2.47|-.84|.328
74029103|NCT05057988|147612513|OTHER|Paired T test|Mean Difference (Final Values)|2.71|STANDARD_DEVIATION|4.95|<|0.001|TWO_SIDED|95.0|1.26|4.16|||t-test, 1 sided|||||4.16|1.26|<.001
74029104|NCT05057988|147612514|OTHER|Paired T test|Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|6.38||0.486|TWO_SIDED|95.0|-1.22|2.53|||t-test, 1 sided|||||2.53|-1.22|.486
73862360|NCT02358044|147270586|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentage|8.8||||0.001|TWO_SIDED|95.0|3.6|15.3|||Miettinen & Nurminen Method|The lower bound of 95% CIs was compared to zero to evaluate superiority. The M=F approach was used to handle missing values.||"Secondary Analysis Approach: Superiority~Analyses of the percentage of participants achieving SVR12 was conducted using the M\&N method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir +elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% CIs and p-values were provided."||15.3|3.6|0.001
73862361|NCT02358044|147270587|SUPERIORITY_OR_OTHER||Difference in Percentage|-41.7|||||TWO_SIDED|95.0|-51.1|-31.9||||||The percentage of participants with an event were assessed via point estimates with 95% CIs provided for between-group comparisons.||-31.9|-51.1|
73862362|NCT02358044|147270589|SUPERIORITY_OR_OTHER||Difference in Percentage|-27.0|||<|0.001|TWO_SIDED|95.0|-35.5|-19.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Total Tier 1 AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-19.6|-35.5|<0.001
73862363|NCT02358044|147270589|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.4||||0.078|TWO_SIDED|95.0|-6.8|0.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Serious drug-related AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||0.6|-6.8|0.078
73862364|NCT02358044|147270589|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.8||||0.312|TWO_SIDED|95.0|-4.4|2.1||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"DC due to drug-related AE:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||2.1|-4.4|0.312
73862365|NCT02358044|147270589|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.7|||<|0.001|TWO_SIDED|95.0|-19.7|-8.0||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Neutrophil count \<0.75 x 10\^9/L:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-8.0|-19.7|<0.001
73862366|NCT02358044|147270589|SUPERIORITY_OR_OTHER||Difference in Percentage|-13.5|||<|0.001|TWO_SIDED|95.0|-20.8|-7.9||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Hemoglobin \<10 g/dL:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-7.9|-20.8|<0.001
73862367|NCT02358044|147270590|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||||TWO_SIDED|95.0|3.3|15.7||||||Analyses of the percentage of participants achieving SVR24 was conducted using the Miettinen \& Nurminen (M\&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided.||15.7|3.3|
73862368|NCT01739803|147270593|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||To control for experiment-wise Type I error rate in this analysis, a comparison-wise alpha of 0.01 was used.|Mixed Models Analysis|||We projected mean composite adherence rate for all participants to be approximately 80% ± 15. We anticipated at least 10% increase in intervention group adherence at end of intervention. To have 80% power to detect expected difference of 10% at the 2-tailed 5% significance level, sample size needed to be at least 36 RTRs per group. We took a conservative approach, in combination with anticipated attrition over the course of study, and increased enrollment.||||<0.05
73862369|NCT01739803|147270594|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
73862370|NCT01739803|147270595|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.05||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
73862371|NCT00969436|147270598|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.||5.09|-2.52|
74029105|NCT05057988|147612515|OTHER|Paired T test|Mean Difference (Final Values)|-0.24|STANDARD_DEVIATION|7.57||0.832|TWO_SIDED|95.0|-2.46|1.99|||t-test, 2 sided|||||1.99|-2.46|.832
74029106|NCT05057988|147612516|OTHER|Paired T test|Mean Difference (Net)|-0.43|STANDARD_DEVIATION|3.06||0.34|TWO_SIDED|95.0|-1.33|0.47|||t-test, 2 sided|||||0.47|-1.33|.340
73862372|NCT00969436|147270598|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.||5.09|-2.52|
73926348|NCT02016482|147380221|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1||||0.025|TWO_SIDED|95.0|-2.0|-0.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS anxiety score||-0.1|-2.0|0.025
73926349|NCT02016482|147380221|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3||||0.005|TWO_SIDED|95.0|-2.3|-0.4||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS depression score||-0.4|-2.3|0.005
74087297|NCT02449473|147728549|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed differential sputum eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.57||||0.6334|TWO_SIDED|95.0|0.06|6.0|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in differential sputum eosinophils; Tralo 300 mg Q2W vs placebo.||6.00|0.06|0.6334
74087298|NCT02449473|147728550|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed blood free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.11||||0.3769|TWO_SIDED|95.0|0.88|1.4|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood free ECP concentration; Tralo 300 mg Q2W vs placebo.||1.40|0.88|0.3769
73926350|NCT02016482|147380222|SUPERIORITY_OR_OTHER||Difference in percentage|2.5||||0.164|TWO_SIDED|95.0|-0.9|6.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Chi-squared|||||6|-0.9|0.164
73926351|NCT02016482|147380223|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-3.4|-2.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-2.1|-3.4|< 0.001
73969082|NCT03097549|147477010|SUPERIORITY||Estimated difference|-1.8|||<|0.001|TWO_SIDED|95.0|-2.8|-0.9|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-0.9|-2.8|<0.001
74087299|NCT02449473|147728551|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed sputum free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.49||||0.1126|TWO_SIDED|95.0|0.2|1.2|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in sputum free ECP concentration; Tralo 300 mg Q2W vs placebo.||1.20|0.20|0.1126
74087300|NCT03064438|147728558|SUPERIORITY||Difference of Least Squares (LS) Mean|1.8|STANDARD_ERROR_OF_MEAN|1.95||0.366|TWO_SIDED|95.0|-2.162|5.727|||t-test, 2 sided|||||5.727|-2.162|0.366
74087301|NCT03064438|147728559|SUPERIORITY|||||||0.1099|||||||Van Elteren test|||Percent change from baseline at Week 2||||0.1099
74087302|NCT03064438|147728559|SUPERIORITY|||||||0.1653|||||||Van Elteren test|||Percent change from baseline at Week 4||||0.1653
74087303|NCT03064438|147728559|SUPERIORITY|||||||0.8437|||||||Van Elteren test|||Percent change from baseline at Week 8||||0.8437
73926352|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|0.74||||0|TWO_SIDED|95.0|0.68|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Non-smoker)||0.82|0.68|0.000
73926353|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.32||||0|TWO_SIDED|95.0|1.14|1.52|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Ex-smoker)||1.52|1.14|0.000
73926354|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.04||||0|TWO_SIDED|95.0|0.93|1.17|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Smoker)||1.17|0.93|0.000
73926355|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|0.95||||0.755|TWO_SIDED|95.0|0.8|1.13|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Non-smoker)||1.13|0.80|0.755
73926356|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.32||||0.426|TWO_SIDED|95.0|0.95|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Ex-smoker)||1.83|0.95|0.426
73969083|NCT03097549|147477011|SUPERIORITY||Estimated difference|-1.6||||0.016|TWO_SIDED|95.0|-2.8|-0.3|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-0.3|-2.8|0.016
73969084|NCT03097549|147477012|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference in usage between treatment group and information group at follow-up.||||0.01
74087304|NCT03064438|147728559|SUPERIORITY|||||||0.4644|||||||Van Elteren test|||Percent change from baseline at Week 12||||0.4644
74087305|NCT03064438|147728560|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74087306|NCT03064438|147728561|SUPERIORITY||Difference of LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.91||0.495|TWO_SIDED|95.0|-2.571|5.211|||t-test, 2 sided|||Change from baseline at Week 2||5.211|-2.571|0.495
74087307|NCT03064438|147728561|SUPERIORITY||Difference of LS Mean|-1.5|STANDARD_ERROR_OF_MEAN|1.74||0.399|TWO_SIDED|95.0|-5.014|2.045|||t-test, 2 sided|||Change from baseline at Week 4||2.045|-5.014|0.399
74087308|NCT03064438|147728561|SUPERIORITY||Difference of LS Mean|2.2|STANDARD_ERROR_OF_MEAN|2.07||0.29|TWO_SIDED|95.0|-1.965|6.407|||t-test, 2 sided|||Change from baseline at Week 8||6.407|-1.965|0.290
74087309|NCT03064438|147728561|SUPERIORITY||Difference of LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.83||0.343|TWO_SIDED|95.0|-1.953|5.469|||t-test, 2 sided|||Change from baseline at Week 12||5.469|-1.953|0.343
74087310|NCT03064438|147728562|SUPERIORITY||Difference of LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.75||0.407|TWO_SIDED|95.0|-0.894|2.155|||t-test, 2 sided|||Change from baseline at Week 2||2.155|-0.894|0.407
74087311|NCT03064438|147728562|SUPERIORITY||Difference of LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.36||0.291|TWO_SIDED|95.0|-0.342|1.109|||t-test, 2 sided|||Change from baseline at Week 4||1.109|-0.342|0.291
73862373|NCT00969436|147270598|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.51|5.02||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.||5.02|-2.51|
73862374|NCT00969436|147270598|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|4.17|||||TWO_SIDED|95.0|1.37|11.57||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.||11.57|1.37|
73862375|NCT00969436|147270598|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.46|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.||5.09|-2.46|
73862376|NCT00969436|147270598|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.48|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.||5.09|-2.48|
73862377|NCT00969436|147270598|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.48|5.02||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.||5.02|-2.48|
73862378|NCT00969436|147270598|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|2.77|||||TWO_SIDED|95.0|-1.59|10.29||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.||10.29|-1.59|
73926357|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.77|1.12|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Smoker)||1.12|0.77|0.930
73862379|NCT02789410|147270607|SUPERIORITY|||||||0.132|||||||Wilcoxon (Mann-Whitney)|||||||0.132
73862380|NCT02789410|147270608|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.590
73862381|NCT02789410|147270609|SUPERIORITY|||||||0.971|||||||Wilcoxon (Mann-Whitney)|||||||0.971
73862382|NCT03474081|147270612|SUPERIORITY||Mean Difference (Net)|0.095|STANDARD_ERROR_OF_MEAN|0.0167|<|0.001|TWO_SIDED|95.0|0.062|0.128||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.128|0.062|<0.001
73862383|NCT03474081|147270613|SUPERIORITY||Mean Difference (Net)|0.122|STANDARD_ERROR_OF_MEAN|0.0144|<|0.001|TWO_SIDED|95.0|0.094|0.15||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.150|0.094|<0.001
73926358|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|0.78||||0|TWO_SIDED|95.0|0.72|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Non-smoker)||0.84|0.72|0.000
73926359|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.25||||0|TWO_SIDED|95.0|1.1|1.42|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Ex-smoker)||1.42|1.10|0.000
73969085|NCT03097549|147477013|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference in improvement between the treatment group and the information group att follow-up.||||<0.001
73926360|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.08||||0|TWO_SIDED|95.0|0.98|1.19|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Smoker)||1.19|0.98|0.000
73926361|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|0.98||||0.755|TWO_SIDED|95.0|0.84|1.14|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Non-smoker)||1.14|0.84|0.755
73926362|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.13||||0.426|TWO_SIDED|95.0|0.84|1.52|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Ex-smoker)||1.52|0.84|0.426
73926363|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|0.98||||0.93|TWO_SIDED|95.0|0.81|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Smoker)||1.12|0.81|0.930
73926364|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|0.79||||0|TWO_SIDED|95.0|0.74|0.84|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Non-smoker)||0.84|0.74|0.000
73926365|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.19||||0|TWO_SIDED|95.0|1.08|1.32|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Ex-smoker)||1.32|1.08|0.000
73969086|NCT05492318|147477019|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric least square mean|105.67|||||TWO_SIDED|90.0|91.72|121.74||||||"Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV.~Cmax"||121.74|91.72|
73926366|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.16||||0|TWO_SIDED|95.0|1.08|1.26|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Smoker)||1.26|1.08|0.000
73926367|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|0.82||||0.755|TWO_SIDED|95.0|0.6|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Non-smoker)||1.13|0.60|0.755
73926368|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.48||||0.426|TWO_SIDED|95.0|0.82|2.52|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Ex-smoker)||2.52|0.82|0.426
73926369|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.0||||0.93|TWO_SIDED|95.0|0.7|1.4|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Smoker)||1.40|0.70|0.930
73926370|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|0.54||||0|TWO_SIDED|95.0|0.49|0.6|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Non-smoker)||0.60|0.49|0.000
73926371|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.51||||0|TWO_SIDED|95.0|1.29|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Ex-smoker)||1.76|1.29|0.000
73926372|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.72||||0|TWO_SIDED|95.0|1.54|1.93|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)||1.93|1.54|0.000
73926373|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|0.91||||0.755|TWO_SIDED|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Non-smoker)||1.17|0.72|0.755
73926374|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|1.25||||0.426|TWO_SIDED|95.0|0.78|1.95|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Ex-smoker)||1.95|0.78|0.426
73926375|NCT03441633|147380224|SUPERIORITY||Odds Ratio (OR)|0.92||||0.93|TWO_SIDED|95.0|0.7|1.2|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)||1.20|0.70|0.930
73926376|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|0.99||||0|TWO_SIDED|95.0|0.9|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (No intake)||1.09|0.90|0.000
73926377|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.11||||0|TWO_SIDED|95.0|0.98|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Moderate intake)||1.25|0.98|0.000
74029107|NCT05057988|147612518|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.31||0.37|TWO_SIDED|95.0|-0.34|0.89|||t-test, 2 sided|paired sample t test||paired sample t test||0.89|-0.34|0.370
74029108|NCT05057988|147612518|OTHER|Paired T test|Mean Difference (Net)|0.28|STANDARD_DEVIATION|2.09||0.37|TWO_SIDED|95.0|-0.34|0.89|||t-test, 2 sided|||||.89|-.34|.370
74029109|NCT00859898|147612524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.1056|<|0.0001|TWO_SIDED|95.0|-0.74|-0.32||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||||-0.32|-0.74|<0.0001
74029110|NCT00859898|147612524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1072|<|0.0001|TWO_SIDED|95.0|-0.75|-0.33||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||||-0.33|-0.75|<0.0001
74029111|NCT00859898|147612524|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change in HbA1c from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 0.35%.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1054|||TWO_SIDED|95.0|-0.22|0.2|||ANCOVA|treatment group as an effect and the baseline value as a covariate||||0.20|-0.22|
74029112|NCT00859898|147612524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1054||0.9144|TWO_SIDED|95.0|-0.22|0.2||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR||0.20|-0.22|0.9144
74029113|NCT00859898|147612525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|3.558|<|0.0001|TWO_SIDED|95.0|-20.9|-7.0||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-7.0|-20.9|<0.0001
74029114|NCT00859898|147612525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.5|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001|TWO_SIDED|95.0|-32.6|-18.5||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-18.5|-32.6|<0.0001
74029115|NCT00859898|147612525|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change FPG from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 15 mg/dL.|Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|3.566|||TWO_SIDED|95.0|-18.6|-4.6|||ANCOVA|treatment group as an effect and the baseline value as a covariate||||-4.6|-18.6|
74029116|NCT00859898|147612525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|3.566||0.0012|TWO_SIDED|95.0|-18.6|-4.6||two-sided significance level at α=0.05.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR||-4.6|-18.6|0.0012
74087312|NCT03064438|147728562|SUPERIORITY||Difference of LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.734|TWO_SIDED|95.0|-0.763|1.073|||t-test, 2 sided|||Change from baseline at Week 8||1.073|-0.763|0.734
74087313|NCT03064438|147728562|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.57||0.952|TWO_SIDED|95.0|-1.128|1.197|||t-test, 2 sided|||Change from baseline in pustule lesions at Week 12||1.197|-1.128|0.952
73862384|NCT03474081|147270614|SUPERIORITY||Mean Difference (Net)|0.087|STANDARD_ERROR_OF_MEAN|0.0159|<|0.001|TWO_SIDED|95.0|0.056|0.118||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.118|0.056|<0.001
73862385|NCT01831817|147270618|SUPERIORITY_OR_OTHER||Mean change difference|-0.1||||0.4321|TWO_SIDED|95.0|-0.35|0.15|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference was First named treatment-second named treatment that a negative difference implied the mean of the second named treatment was larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.15|-0.35|0.4321
73862386|NCT01831817|147270618|SUPERIORITY_OR_OTHER||Mean change difference|-0.48||||0.0002|TWO_SIDED|95.0|-0.73|-0.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.23|-0.73|0.0002
73862387|NCT01831817|147270618|SUPERIORITY_OR_OTHER||Mean change difference|-0.49||||0.0002|TWO_SIDED|95.0|-0.74|-0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.24|-0.74|0.0002
73862388|NCT01831817|147270618|SUPERIORITY_OR_OTHER||Mean change difference|0.38||||0.0028|TWO_SIDED|95.0|0.13|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.63|0.13|0.0028
73862389|NCT01831817|147270618|SUPERIORITY_OR_OTHER||Mean change difference|0.39||||0.0022|TWO_SIDED|95.0|0.14|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline waas the same for both treatments in all pairwise comparisons||0.63|0.14|0.0022
73862390|NCT01831817|147270618|SUPERIORITY_OR_OTHER||Mean change difference|-0.01||||0.9606|TWO_SIDED|95.0|-0.25|0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.24|-0.25|0.9606
73862391|NCT01831817|147270619|SUPERIORITY_OR_OTHER||Mean change difference|0.04||||0.803|TWO_SIDED|95.0|-0.3|0.38|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.38|-0.30|0.8030
73862392|NCT01831817|147270619|SUPERIORITY_OR_OTHER||Mean change difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.48|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.48|-1.16|<0.0001
73862393|NCT01831817|147270619|SUPERIORITY_OR_OTHER||Mean change difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.53|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.53|-1.20|<0.0001
73862394|NCT01831817|147270619|SUPERIORITY_OR_OTHER||Mean change difference|0.86|||<|0.0001|TWO_SIDED|95.0|0.53|1.19|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||1.19|0.53|<0.0001
73926378|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.52||||0.164|TWO_SIDED|95.0|0.94|2.45|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Risk consumption)||2.45|0.94|0.164
73926379|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.03||||0.826|TWO_SIDED|95.0|0.87|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (No intake)||1.22|0.87|0.826
73926380|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.16||||0.19|TWO_SIDED|95.0|0.94|1.43|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Moderate intake)||1.43|0.94|0.190
73926381|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|0.58||||0.526|TWO_SIDED|95.0|0.18|1.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Risk consumption)||1.57|0.18|0.526
74029117|NCT00859898|147612526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|4.598||0.0012|TWO_SIDED|95.0|5.9|23.9||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||23.9|5.9|0.0012
74087314|NCT03064438|147728563|SUPERIORITY||Difference of LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.313|TWO_SIDED|95.0|-0.215|0.069|||t-test, 2 sided|||Change from baseline at Week 2||0.069|-0.215|0.313
73926382|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|0.84||||0|TWO_SIDED|95.0|0.77|0.91|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (No intake)||0.91|0.77|0.000
73926383|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.12||||0|TWO_SIDED|95.0|1.01|1.24|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Moderate intake)||1.24|1.01|0.000
73926384|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.17||||0.164|TWO_SIDED|95.0|0.76|1.83|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Risk consumption)||1.83|0.76|0.164
73926385|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.09||||0.826|TWO_SIDED|95.0|0.95|1.26|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (No intake)||1.26|0.95|0.826
73926386|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|0.93||||0.19|TWO_SIDED|95.0|0.77|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Moderate intake)||1.13|0.77|0.190
73926387|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.26||||0.526|TWO_SIDED|95.0|0.62|2.65|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Risk consumption)||2.65|0.62|0.526
73926388|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.36||||0|TWO_SIDED|95.0|1.28|1.45|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (No intake)||1.45|1.28|0.000
73926389|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.24||||0|TWO_SIDED|95.0|1.14|1.35|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Moderate intake)||1.35|1.14|0.000
73969087|NCT05492318|147477019|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric least square mean|91.56|||||TWO_SIDED|90.0|86.16|97.31||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||97.31|86.16|
73969088|NCT05492318|147477019|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|92.13|||||TWO_SIDED|90.0|75.97|111.73||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||111.73|75.97|
73969089|NCT05492318|147477019|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|93.59|||||TWO_SIDED|90.0|83.72|104.63||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||104.63|83.72|
73969090|NCT05492318|147477019|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|124.02|||||TWO_SIDED|90.0|114.38|134.47||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||134.47|114.38|
74087315|NCT03064438|147728563|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.942|TWO_SIDED|95.0|-0.141|0.152|||t-test, 2 sided|||Change from baseline at Week 4||0.152|-0.141|0.942
73926390|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.36||||0.164|TWO_SIDED|95.0|0.98|1.95|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Risk consumption)||1.95|0.98|0.164
73926391|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.04||||0.826|TWO_SIDED|95.0|0.76|1.41|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (No intake)||1.41|0.76|0.826
73926392|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.22||||0.19|TWO_SIDED|95.0|0.82|1.76|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Moderate intake)||1.76|0.82|0.190
73926393|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.21||||0.526|TWO_SIDED|95.0|0.17|4.5|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Risk consumption)||4.50|0.17|0.526
73926394|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.28||||0|TWO_SIDED|95.0|1.16|1.42|||Chi-squared|||Warfarin vs. Apixaban in naive participants (No intake)||1.42|1.16|0.000
73926395|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.25||||0|TWO_SIDED|95.0|1.1|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Moderate intake)||1.43|1.10|0.000
73926396|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|0.92||||0.164|TWO_SIDED|95.0|0.49|1.64|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Risk consumption)||1.64|0.49|0.164
73926397|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|1.06||||0.826|TWO_SIDED|95.0|0.84|1.34|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (No intake)||1.34|0.84|0.826
73926398|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|0.91||||0.19|TWO_SIDED|95.0|0.66|1.23|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Moderate intake)||1.23|0.66|0.190
73926399|NCT03441633|147380225|SUPERIORITY||Odds Ratio (OR)|0.64||||0.526|TWO_SIDED|95.0|0.09|2.36|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Risk consumption)||2.36|0.09|0.526
73926400|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.36||||0|TWO_SIDED|95.0|1.2|1.53|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.53|1.20|0.000
73926401|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.01||||0.014|TWO_SIDED|95.0|0.89|1.15|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 2 - Urban area)||1.15|0.89|0.014
73926402|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.87||||0|TWO_SIDED|95.0|0.77|0.99|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 3 - Urban area)||0.99|0.77|0.000
73926403|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.86||||0|TWO_SIDED|95.0|0.75|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 4 - Urban area)||0.97|0.75|0.000
73926404|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.85||||0.013|TWO_SIDED|95.0|0.74|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 5 - Urban area)||0.97|0.74|0.013
73969091|NCT05492318|147477019|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|117.47|||||TWO_SIDED|90.0|104.78|131.69||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Max||131.69|104.78|
73969092|NCT05492318|147477019|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of geometric LS means|139.28|||||TWO_SIDED|90.0|128.71|150.67||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||150.67|128.71|
73926405|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.05||||0.157|TWO_SIDED|95.0|0.84|1.31|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.31|0.84|0.157
73926406|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.03||||0.124|TWO_SIDED|95.0|0.82|1.29|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.29|0.82|0.124
73926407|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.77||||0.062|TWO_SIDED|95.0|0.61|0.96|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||0.96|0.61|0.062
73926408|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.98||||0.079|TWO_SIDED|95.0|0.78|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.22|0.78|0.079
73926409|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.09||||0.14|TWO_SIDED|95.0|0.86|1.38|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.38|0.86|0.140
73926410|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.31||||0|TWO_SIDED|95.0|1.17|1.45|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.45|1.17|0.000
73926411|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.97||||0.014|TWO_SIDED|95.0|0.87|1.09|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 2 - Urban area)||1.09|0.87|0.014
73926412|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.01||||0|TWO_SIDED|95.0|0.91|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 3 - Urban area)||1.12|0.91|0.000
73926413|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.94||||0|TWO_SIDED|95.0|0.85|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 4 - Urban area)||1.05|0.85|0.000
73926414|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.83||||0.013|TWO_SIDED|95.0|0.74|0.93|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 5 - Urban area)||0.93|0.74|0.013
73926415|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.92||||0.157|TWO_SIDED|95.0|0.76|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.13|0.76|0.157
73926416|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.98||||0.124|TWO_SIDED|95.0|0.81|1.2|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.20|0.81|0.124
73969093|NCT05492318|147477019|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of geometric LS means|141.61|||||TWO_SIDED|90.0|122.36|163.88||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||163.88|122.36|
73969094|NCT05492318|147477020|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|73.68|||||TWO_SIDED|90.0|60.77|89.33||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||89.33|60.77|
74029118|NCT00859898|147612526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|4.73||0.0165|TWO_SIDED|95.0|2.1|20.6||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||20.6|2.1|0.0165
74087316|NCT03064438|147728563|SUPERIORITY||Difference of LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.284|TWO_SIDED|95.0|-0.067|0.226|||t-test, 2 sided|||Change from baseline in nodule lesions at Week 8||0.226|-0.067|0.284
73926417|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.79||||0.062|TWO_SIDED|95.0|0.65|0.96|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||0.96|0.65|0.062
74087317|NCT03064438|147728563|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.542|TWO_SIDED|95.0|-0.198|0.105|||t-test, 2 sided|||Change from baseline at Week 12||0.105|-0.198|0.542
74087318|NCT03064438|147728564|SUPERIORITY||Difference of LS Mean|2.0|STANDARD_ERROR_OF_MEAN|2.04||0.333|TWO_SIDED|95.0|-2.135|6.139|||t-test, 2 sided|||Change from baseline at Week 2||6.139|-2.135|0.333
74087319|NCT03064438|147728564|SUPERIORITY||Difference of LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.9||0.591|TWO_SIDED|95.0|-4.882|2.822|||t-test, 2 sided|||Change from baseline at Week 4||2.822|-4.882|0.591
74087320|NCT03064438|147728564|SUPERIORITY||Difference of LS Mean|2.5|STANDARD_ERROR_OF_MEAN|2.12||0.254|TWO_SIDED|95.0|-1.84|6.758|||t-test, 2 sided|||Change from baseline at Week 8||6.758|-1.840|0.254
74087321|NCT03064438|147728564|SUPERIORITY||Difference of LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.95||0.356|TWO_SIDED|95.0|-2.131|5.779|||t-test, 2 sided|||Change from baseline at Week 12||5.779|-2.131|0.356
74087322|NCT01002794|147728673|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||Power calculation: The sample size calculation was based on the change in KOOS4 from baseline to two year follow-up. To detect a 10 point difference with a standard deviation of 15, with a level of power of 90%, level of significance of 0.05, and an estimated 15% dropout rate at two years, we determined that we would need 56 participants in each group. To allow for a 20% crossover rate, we randomised 140 participants.||||<0.05
73926418|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.23||||0.079|TWO_SIDED|95.0|1.02|1.48|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.48|1.02|0.079
73926419|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.21||||0.14|TWO_SIDED|95.0|0.99|1.49|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.49|0.99|0.140
74087323|NCT03662308|147728709|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
74087324|NCT02065713|147728716|SUPERIORITY||||||=|0.026|||||||Wilcoxon (Mann-Whitney)|||||||=0.026
73926420|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.96||||0|TWO_SIDED|95.0|0.88|1.05|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.05|0.88|0.000
73926421|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.91||||0.014|TWO_SIDED|95.0|0.84|0.99|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 2 - Urban area)||0.99|0.84|0.014
73926422|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.83||||0|TWO_SIDED|95.0|0.76|0.9|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 3 - Urban area)||0.90|0.76|0.000
73926423|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.84||||0|TWO_SIDED|95.0|0.77|0.91|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 4 - Urban area)||0.91|0.77|0.000
73926424|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.92||||0.013|TWO_SIDED|95.0|0.85|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 5 - Urban area)||1.00|0.85|0.013
74087325|NCT03614494|147728717|SUPERIORITY||Risk Difference (RD)|31.4|||<|0.0001|TWO_SIDED|95.0|26.2|36.4|||Chi-squared|||||36.4|26.2|<0.0001
73862395|NCT01831817|147270619|SUPERIORITY_OR_OTHER||Mean change difference|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||1.23|0.58|<0.0001
73862396|NCT01831817|147270619|SUPERIORITY_OR_OTHER||Mean change difference|-0.04||||0.7872|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.28|-0.37|0.7872
73862397|NCT01831817|147270620|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.9642|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.9642
73862398|NCT01831817|147270620|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.0016|TWO_SIDED|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|0.00|0.0016
73862399|NCT01831817|147270620|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.01|TWO_SIDED|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|0.00|0.0100
73862400|NCT01831817|147270620|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.002|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|0.00|0.0020
73862401|NCT01831817|147270620|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.0122|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|0.00|0.0122
73862402|NCT01831817|147270620|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.7138|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.7138
74087326|NCT03614494|147728718|SUPERIORITY||Odds Ratio (OR)|0.197||||0.036|TWO_SIDED|95.0|0.021|0.906|||Logistic regression, Firth's bias reduct|||||0.906|0.021|0.036
74087327|NCT00418522|147728719|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.19|||<|0.0001||95.0|-0.38|0.0|||ANCOVA||A confidence interval (CI) approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.||0|-0.38|<0.0001
73862403|NCT01831817|147270621|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.9834|TWO_SIDED|95.0|-5.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|-5.00|0.9834
73862404|NCT01831817|147270621|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|5.0||||0.0001|TWO_SIDED|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||15.00|0.00|0.0001
73862405|NCT01831817|147270621|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|2.5||||0.0003|TWO_SIDED|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||15.00|0.00|0.0003
73862406|NCT01831817|147270621|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|-5.0|||<|0.0001|TWO_SIDED|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|-10.00|<0.0001
73862407|NCT01831817|147270621|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|-5.0||||0.0002|TWO_SIDED|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|-10.00|0.0002
73862408|NCT01831817|147270621|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.2894|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.2894
73862409|NCT01831817|147270622|SUPERIORITY_OR_OTHER||Mean change difference|-0.24||||0.5555|TWO_SIDED|95.0|-1.03|0.56|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.56|-1.03|0.5555
73926425|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.03||||0.157|TWO_SIDED|95.0|0.68|1.54|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.54|0.68|0.157
73926426|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.84||||0.124|TWO_SIDED|95.0|0.53|1.29|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.29|0.53|0.124
73926427|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.75||||0.062|TWO_SIDED|95.0|0.48|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||1.13|0.48|0.062
73926428|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.88||||0.079|TWO_SIDED|95.0|0.57|1.33|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.33|0.57|0.079
73926429|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.05||||0.14|TWO_SIDED|95.0|0.67|1.59|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.59|0.67|0.140
73926430|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.39||||0|TWO_SIDED|95.0|0.32|0.47|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 1 - Urban area)||0.47|0.32|0.000
73926431|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.84||||0.014|TWO_SIDED|95.0|0.73|0.97|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 2 - Urban area)||0.97|0.73|0.014
73926432|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.7||||0|TWO_SIDED|95.0|1.51|1.91|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 3 - Urban area)||1.91|1.51|0.000
73926433|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.86||||0|TWO_SIDED|95.0|1.65|2.1|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 4 - Urban area)||2.10|1.65|0.000
73926434|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.94||||0.013|TWO_SIDED|95.0|0.82|1.08|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 5 - Urban area)||1.08|0.82|0.013
73926435|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.35||||0.157|TWO_SIDED|95.0|1.0|1.8|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.80|1.00|0.157
73862410|NCT01831817|147270622|SUPERIORITY_OR_OTHER||Mean change difference|-0.06||||0.8769|TWO_SIDED|95.0|-0.86|0.73|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.73|-0.86|0.8769
73862411|NCT01831817|147270622|SUPERIORITY_OR_OTHER||Mean change difference|-0.76||||0.0562|TWO_SIDED|95.0|-1.55|0.02|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.02|-1.55|0.0562
73862412|NCT01831817|147270622|SUPERIORITY_OR_OTHER||Mean change difference|-0.18||||0.6562|TWO_SIDED|95.0|-0.95|0.6|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.60|-0.95|0.6562
73862413|NCT01831817|147270622|SUPERIORITY_OR_OTHER||Mean change difference|0.53||||0.1788|TWO_SIDED|95.0|-0.24|1.3|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||1.30|-0.24|0.1788
73862414|NCT01831817|147270622|SUPERIORITY_OR_OTHER||Mean change difference|-0.7||||0.0734|TWO_SIDED|95.0|-1.47|0.07|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.07|-1.47|0.0734
73862415|NCT01831817|147270623|SUPERIORITY_OR_OTHER||Mean change difference|0.19||||0.6727|TWO_SIDED|95.0|-0.71|1.1|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||1.10|-0.71|0.6727
73862416|NCT01831817|147270623|SUPERIORITY_OR_OTHER||Mean change difference|-1.24||||0.0072|TWO_SIDED|95.0|-2.14|-0.34|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||-0.34|-2.14|0.0072
73862417|NCT01831817|147270623|SUPERIORITY_OR_OTHER||Mean change difference|-1.27||||0.0056|TWO_SIDED|95.0|-2.16|-0.38|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||-0.38|-2.16|0.0056
73969095|NCT05492318|147477020|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|70.38|||||TWO_SIDED|90.0|57.94|85.5||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||85.50|57.94|
73862418|NCT01831817|147270623|SUPERIORITY_OR_OTHER||Mean change diference|1.43||||0.0016|TWO_SIDED|95.0|0.56|2.31|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||2.31|0.56|0.0016
73862419|NCT01831817|147270623|SUPERIORITY_OR_OTHER||Mean change difference|1.46||||0.0011|TWO_SIDED|95.0|0.59|2.33|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||2.33|0.59|0.0011
73926436|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|1.41||||0.124|TWO_SIDED|95.0|1.04|1.88|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.88|1.04|0.124
73926437|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.76||||0.062|TWO_SIDED|95.0|0.55|1.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||1.05|0.55|0.062
73926438|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.92||||0.079|TWO_SIDED|95.0|0.67|1.26|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.26|0.67|0.079
73969096|NCT05492318|147477020|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|65.31|||||TWO_SIDED|90.0|53.33|79.98||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||79.98|53.33|
74087328|NCT00418522|147728719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0516||95.0|-0.38|0.0|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).||0|-0.38|0.0516
74087329|NCT00418522|147728720|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.0052||95.0|1.22|3.14|||Regression, Logistic|||||3.14|1.22|0.0052
73862420|NCT01831817|147270623|SUPERIORITY_OR_OTHER||Mean change difference|-0.03||||0.9413|TWO_SIDED|95.0|-0.9|0.84|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.84|-0.90|0.9413
73926439|NCT03441633|147380226|SUPERIORITY||Odds Ratio (OR)|0.81||||0.14|TWO_SIDED|95.0|0.56|1.15|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.15|0.56|0.140
73926440|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.91|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.25|0.91|0.000
73926441|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.38||||0.202|TWO_SIDED|95.0|0.58|3.23|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||3.23|0.58|0.202
73926442|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.98||||0|TWO_SIDED|95.0|0.88|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.09|0.88|0.000
73926443|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.84||||0.003|TWO_SIDED|95.0|0.76|0.93|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||0.93|0.76|0.003
74087330|NCT00418522|147728721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0022||95.0|1.29|3.15|||Regression, Logistic|||||3.15|1.29|0.0022
73862421|NCT01742065|147270636|SUPERIORITY|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclinic correlation coefficient was 0.05 after model covariates adjustment.|Mean Difference (Final Values)|3.4||||0.05|TWO_SIDED|95.0|0.1|6.8||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.||||6.8|.1|.05
73862422|NCT01742065|147270637|OTHER|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclass correlation coefficient was 0.05 after covariable adjustment.|Mean Difference (Final Values)|3.8||||0.02|TWO_SIDED|95.0|0.6|7.0||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.||||7|.6|.02
73862423|NCT00541346|147270653|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|26.3|||<|0.001|TWO_SIDED|95.0|19.6|33.1||Posterior-Predictive Probability of Mean Change (Pre-Post) Score at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||33.1|19.6|<0.001
73862424|NCT00541346|147270654|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|23.1|||<|0.001|TWO_SIDED|95.0|16.9|29.3||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||29.3|16.9|<0.001
73862425|NCT00541346|147270655|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|10.9|||<|0.001|TWO_SIDED|95.0|5.4|16.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.||Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||16.8|5.4|<0.001
73862426|NCT00541346|147270656|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|7.2|||<|0.001|TWO_SIDED|95.0|3.3|11.1||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||11.1|3.3|<0.001
73862427|NCT00541346|147270657|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|4.1|||<|0.01||95.0|1.2|6.9||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||6.9|1.2|<0.01
73926444|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.82||||0.083|TWO_SIDED|95.0|0.66|1.03|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.03|0.66|0.083
73926445|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.99||||0.011|TWO_SIDED|95.0|0.68|6.18|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||6.18|0.68|0.011
73926446|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.89||||0.227|TWO_SIDED|95.0|0.75|1.06|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.06|0.75|0.227
74087331|NCT00418522|147728722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.248||95.0|0.4|1.27|||Regression, Logistic|||||1.27|0.40|0.2480
74087332|NCT00418522|147728723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.57||||0.6091||95.0|-7.31|12.46|||ANCOVA|||||12.46|-7.31|0.6091
74087333|NCT00418522|147728724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.96|||<|0.0001||95.0|22.66|43.25|||ANCOVA|||Time 0 (fasting) at Week 26.||43.25|22.66|<0.0001
74087334|NCT00418522|147728724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||<|0.0001||95.0|16.55|40.59|||ANCOVA|||Time 30 at Week 26.||40.59|16.55|<0.0001
73862428|NCT00541346|147270658|SUPERIORITY_OR_OTHER||Bayesian random intercept model.|3.5|||<|0.001|TWO_SIDED|95.0|1.8|5.2||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||5.2|1.8|<0.001
73862429|NCT00541346|147270659|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-10.9|||<|0.001|TWO_SIDED|95.0|-16.8|-5.4||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||-5.4|-16.8|<0.001
73862430|NCT00541346|147270660|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|1.94|||>|0.21|TWO_SIDED|95.0|-2.98|6.82||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||6.82|-2.98|>0.21
73862431|NCT00541346|147270661|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-3.4|||>|0.06|TWO_SIDED|95.0|-7.9|0.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||0.80|-7.9|>0.06
73862432|NCT00541346|147270662|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-5.26|||<|0.01|TWO_SIDED|95.0|-9.37|-1.18||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||-1.18|-9.37|<0.01
73862433|NCT00541346|147270663|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|7.6|||>|0.11|TWO_SIDED|95.0|-5.6|20.7||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||20.7|-5.6|>0.11
73862434|NCT05160766|147270672|OTHER||Difference of means in percent|12.557|STANDARD_ERROR_OF_MEAN|5.661||0.03143|TWO_SIDED|95.0|1.168|23.946|||ANCOVA|||The statistical analysis reflects Part A of the study.||23.946|1.168|0.03143
73862435|NCT05160766|147270672|OTHER||Difference of means in percent|4.331|STANDARD_ERROR_OF_MEAN|1.671||0.0101|TWO_SIDED|95.0|1.04|7.621|||ANCOVA|||This statistical analysis reflects Part B of the study.||7.621|1.04|0.0101
73862436|NCT05160766|147270673|OTHER||Difference of means in percent|12.168|STANDARD_ERROR_OF_MEAN|5.88||0.04405|TWO_SIDED|95.0|0.338|23.998|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|23.998|0.338|0.04405
73862437|NCT05160766|147270673|OTHER||Difference of means in percent|14.212|STANDARD_ERROR_OF_MEAN|5.767||0.01744|TWO_SIDED|95.0|2.61|25.814|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.351 (beta)."|25.814|2.61|0.01744
73862438|NCT05160766|147270673|OTHER||Difference of means in percent|14.239|STANDARD_ERROR_OF_MEAN|5.932||0.02039|TWO_SIDED|95.0|2.305|26.173|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.1 (gamma)."|26.173|2.305|0.02039
73862439|NCT05160766|147270673|OTHER||Difference of means in percent|9.331|STANDARD_ERROR_OF_MEAN|4.636||0.04989|TWO_SIDED|95.0|0.005|18.656|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.1 (omicron)."|18.656|0.005|0.04989
73862440|NCT05160766|147270673|OTHER||Difference of means in percent|10.312|STANDARD_ERROR_OF_MEAN|4.373||0.02259|TWO_SIDED|95.0|1.514|19.111|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4 (omicron)."|19.111|1.514|0.02259
73862441|NCT05160766|147270673|OTHER||Difference of means in percent|11.601|STANDARD_ERROR_OF_MEAN|4.634||0.01583|TWO_SIDED|95.0|2.279|20.924|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|20.924|2.279|0.01583
74087335|NCT00418522|147728724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.96||||0.0044||95.0|5.96|31.96|||ANCOVA|||Time 60 at Week 26.||31.96|5.96|0.0044
74087336|NCT00418522|147728724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.69||||0.3168||95.0|-6.45|19.83|||ANCOVA|||Time 90 at Week 26.||19.83|-6.45|0.3168
73862442|NCT05160766|147270673|OTHER||Difference of means in percent|11.863|STANDARD_ERROR_OF_MEAN|4.323||0.00856|TWO_SIDED|95.0|3.166|20.56|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.5 (omicron)."|20.56|3.166|0.00856
73862443|NCT05160766|147270673|OTHER||Difference of means in percent|6.83|STANDARD_ERROR_OF_MEAN|2.244||0.00258|TWO_SIDED|95.0|2.41|11.249|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|11.249|2.41|0.00258
73862444|NCT05160766|147270673|OTHER||Difference of means in percent|6.048|STANDARD_ERROR_OF_MEAN|2.244||0.00748|TWO_SIDED|95.0|1.63|10.466|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.351 (beta)."|10.466|1.63|0.00748
73862445|NCT05160766|147270673|OTHER||Difference of means in percent|7.302|STANDARD_ERROR_OF_MEAN|2.782||0.00922|TWO_SIDED|95.0|1.821|12.782|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.1 (gamma)."|12.782|1.821|0.00922
73862446|NCT05160766|147270673|OTHER||Difference of means in percent|4.791|STANDARD_ERROR_OF_MEAN|2.646||0.07136|TWO_SIDED|95.0|-0.419|10.001|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.1 (omicron)."|10.001|-0.419|0.07136
73862447|NCT05160766|147270673|OTHER||Difference of means in percent|3.965|STANDARD_ERROR_OF_MEAN|2.196||0.07218|TWO_SIDED|95.0|-0.36|8.29|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4 (omicron)."|8.29|-0.36|0.07218
73862448|NCT05160766|147270673|OTHER||Difference of means in percent|4.82|STANDARD_ERROR_OF_MEAN|2.202||0.02949|TWO_SIDED|95.0|0.484|9.155|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|9.155|0.484|0.02949
73862449|NCT05160766|147270673|OTHER||Difference of means in percent|3.926|STANDARD_ERROR_OF_MEAN|2.263||0.08403|TWO_SIDED|95.0|-0.531|8.382|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.5 (omicron)."|8.382|-0.531|0.08403
73862450|NCT05160766|147270676|OTHER||Difference of means in percent|8.835|STANDARD_ERROR_OF_MEAN|11.03||0.42797|TWO_SIDED|95.0|-13.475|31.145|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|31.145|-13.475|0.42797
73862451|NCT05160766|147270676|OTHER||Difference of means in percent|3.54|STANDARD_ERROR_OF_MEAN|10.575||0.73961|TWO_SIDED|95.0|-17.85|24.929|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.351 (beta)."|24.929|-17.85|0.73961
73862452|NCT05160766|147270676|OTHER||Difference of means in percent|8.086|STANDARD_ERROR_OF_MEAN|10.683||0.4537|TWO_SIDED|95.0|-13.524|29.695|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.1 (gamma)."|29.695|-13.524|0.45370
73926447|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.23||||0|TWO_SIDED|95.0|1.03|1.47|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.47|1.03|0.000
74029780|NCT03151148|147614041|SUPERIORITY||Geometric mean ratio (GMR)|11.539||||0.181|TWO_SIDED|95.0|0.318|418.7586|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||418.7586|0.3180|0.181
73862453|NCT05160766|147270676|OTHER||Difference of means in percent|1.636|STANDARD_ERROR_OF_MEAN|10.187||0.87323|TWO_SIDED|95.0|-18.969|22.241|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.1 (omicron)."|22.241|-18.969|0.87323
73862454|NCT05160766|147270676|OTHER||Difference of means in percent|0.81|STANDARD_ERROR_OF_MEAN|9.848||0.93489|TWO_SIDED|95.0|-19.109|20.728|||ANCOVA|||This statistical analysis relfects Part A of the study.|"The above provided values refer to the variant BA.4 (omicron)."|20.728|-19.109|0.93489
73862455|NCT05160766|147270676|OTHER||Difference of means in percent|3.511|STANDARD_ERROR_OF_MEAN|10.845||0.74784|TWO_SIDED|95.0|-18.425|25.448|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|25.448|-18.425|0.74784
73862456|NCT05160766|147270676|OTHER||Difference of means in percent|2.088|STANDARD_ERROR_OF_MEAN|10.409||0.84202|TWO_SIDED|95.0|-18.966|23.143|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.5 (omicron)."|23.143|-18.966|0.84202
73862457|NCT05160766|147270676|OTHER||Difference of means in percent|5.807|STANDARD_ERROR_OF_MEAN|4.068||0.15477|TWO_SIDED|95.0|-2.207|13.821|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|13.821|-2.207|0.15477
73862458|NCT05160766|147270676|OTHER||Difference of means in percent|3.52|STANDARD_ERROR_OF_MEAN|3.984||0.37773|TWO_SIDED|95.0|-4.327|11.368|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.351 (beta)."|11.368|-4.327|0.37773
73862459|NCT05160766|147270676|OTHER||Difference of means in percent|4.413|STANDARD_ERROR_OF_MEAN|4.18||0.29212|TWO_SIDED|95.0|-3.821|12.647|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.1 (gamma)."|12.647|-3.821|0.29212
73862460|NCT05160766|147270676|OTHER||Difference of means in percent|5.961|STANDARD_ERROR_OF_MEAN|4.04||0.1414|TWO_SIDED|95.0|-1.998|13.919|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.1 (omicron)."|13.919|-1.998|0.14140
73862461|NCT05160766|147270676|OTHER||Difference of means in percent|2.199|STANDARD_ERROR_OF_MEAN|3.875||0.5709|TWO_SIDED|95.0|-5.434|9.832|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4 (omicron)."|9.832|-5.434|0.57090
73862462|NCT05160766|147270676|OTHER||Difference of means in percent|6.528|STANDARD_ERROR_OF_MEAN|4.071||0.11012|TWO_SIDED|95.0|-1.491|14.548|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|14.548|-1.491|0.11012
73926448|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.01||||0|TWO_SIDED|95.0|0.88|1.16|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.16|0.88|0.000
73862463|NCT05160766|147270676|OTHER||Difference of means in percent|4.239|STANDARD_ERROR_OF_MEAN|4.06||0.29755|TWO_SIDED|95.0|-3.759|12.237|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.5 (omicron)."|12.237|-3.759|0.29755
73862464|NCT05160766|147270681|OTHER||Difference of means in percent|9.64|STANDARD_ERROR_OF_MEAN|11.191||0.39426|TWO_SIDED|95.0|-12.995|32.275|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.2 (gamma)."|32.275|-12.995|0.39426
73926449|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.22||||0.202|TWO_SIDED|95.0|0.58|2.66|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||2.66|0.58|0.202
73926450|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.95||||0|TWO_SIDED|95.0|0.87|1.04|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.04|0.87|0.000
73969097|NCT05492318|147477020|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|62.18|||||TWO_SIDED|90.0|50.86|75.95||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate. Cmax||75.95|50.86|
73969098|NCT05492318|147477025|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric LS means|107.35|||||TWO_SIDED|90.0|103.35|111.49||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||111.49|103.35|
73969099|NCT05492318|147477025|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|106.18|||||TWO_SIDED|90.0|100.84|111.8||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||111.80|100.84|
73969100|NCT05492318|147477025|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|121.77|||||TWO_SIDED|90.0|117.56|126.12||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||126.12|117.56|
73969101|NCT05492318|147477025|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|122.97|||||TWO_SIDED|90.0|115.08|131.41||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||131.41|115.08|
73969102|NCT05492318|147477025|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|137.42|||||TWO_SIDED|90.0|128.09|147.43||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-t||147.43|128.09|
73969103|NCT05492318|147477025|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|131.21|||||TWO_SIDED|90.0|122.47|140.59||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-t||140.59|122.47|
74029119|NCT00859898|147612527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.1807||0.0133|TWO_SIDED|95.0|-0.81|-0.09||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|: treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.09|-0.81|0.0133
73862465|NCT05160766|147270681|OTHER||Difference of means in percent|8.764|STANDARD_ERROR_OF_MEAN|10.765||0.42055|TWO_SIDED|95.0|-13.011|30.539|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617."|30.539|-13.011|0.42055
73969104|NCT05492318|147477025|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|157.77|||||TWO_SIDED|90.0|147.49|168.76||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam. - AUC0-t||168.76|147.49|
73969105|NCT05492318|147477025|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|158.3|||||TWO_SIDED|90.0|145.23|172.54||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: - AUC0-t||172.54|145.23|
73969106|NCT05492318|147477026|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.9|||||TWO_SIDED|90.0|58.43|83.64||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics - AUC0-t||83.64|58.43|
74087337|NCT00418522|147728724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.9222||95.0|-12.12|13.39|||ANCOVA|||Time 120 at Week 26.||13.39|-12.12|0.9222
73862466|NCT05160766|147270681|OTHER||Difference of means in percent|8.472|STANDARD_ERROR_OF_MEAN|10.953||0.44391|TWO_SIDED|95.0|-13.683|30.627|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617.1 (kappa)."|30.627|-13.683|0.44391
73862467|NCT05160766|147270681|OTHER||Difference of means in percent|8.483|STANDARD_ERROR_OF_MEAN|10.82||0.43775|TWO_SIDED|95.0|-13.402|30.368|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant AY.3 (delta)."|30.368|-13.402|0.43775
73862468|NCT05160766|147270681|OTHER||Difference of means in percent|6.19|STANDARD_ERROR_OF_MEAN|9.892||0.53511|TWO_SIDED|95.0|-13.819|26.2|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant AY.4.2 (delta)."|26.2|-13.819|0.53511
73926451|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.87||||0.003|TWO_SIDED|95.0|0.8|0.95|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||0.95|0.80|0.003
73926452|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.97||||0.083|TWO_SIDED|95.0|0.8|1.17|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.17|0.80|0.083
73926453|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.06||||0.011|TWO_SIDED|95.0|0.02|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||1.05|0.02|0.011
74029120|NCT00859898|147612527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.1817||0.0036|TWO_SIDED|95.0|-0.89|-0.18||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.18|-0.89|0.0036
74087338|NCT00418522|147728724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.695||95.0|-14.51|9.69|||ANCOVA|||Time 180 at Week 26.||9.69|-14.51|0.6950
73926454|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.84||||0.227|TWO_SIDED|95.0|0.72|0.98|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||0.98|0.72|0.227
73926455|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.16||||0|TWO_SIDED|95.0|0.99|1.35|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.35|0.99|0.000
73926456|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.63||||0|TWO_SIDED|95.0|1.47|1.82|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.82|1.47|0.000
73926457|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.7||||0.202|TWO_SIDED|95.0|0.98|3.25|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||3.25|0.98|0.202
73926458|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.29||||0|TWO_SIDED|95.0|1.2|1.38|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.38|1.20|0.000
73926459|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.94||||0.003|TWO_SIDED|95.0|0.88|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||1.00|0.88|0.003
73926460|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.86||||0.083|TWO_SIDED|95.0|0.56|1.28|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.28|0.56|0.083
74087339|NCT00418522|147728725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.61||||0.1207||95.0|-21.76|2.54|||ANCOVA|||Post-Breakfast, Week 26.||2.54|-21.76|0.1207
74087340|NCT00418522|147728725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.11|||<|0.0001||95.0|-39.77|-18.44|||ANCOVA|||Post-Lunch, Week 26.||-18.44|-39.77|<0.0001
74087341|NCT00418522|147728725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.76|||<|0.0001||95.0|-44.17|-23.35|||ANCOVA|||Post-Dinner, Week 26.||-23.35|-44.17|<0.0001
74087342|NCT00418522|147728726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21||||0.0735||95.0|-0.5|10.91|||ANCOVA|||Total Cholesterol at Week 26.||10.91|-0.50|0.0735
74087343|NCT00418522|147728726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.0017||95.0|0.79|3.39|||ANCOVA|||HDL-c at Week 26.||3.39|0.79|0.0017
74087344|NCT00418522|147728726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43||||0.1369||95.0|-1.1|7.96|||ANCOVA|||LDL-c at Week 26.||7.96|-1.10|0.1369
73926461|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.49||||0.011|TWO_SIDED|95.0|0.13|8.58|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||8.58|0.13|0.011
73926462|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.04||||0.227|TWO_SIDED|95.0|0.75|1.42|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.42|0.75|0.227
73926463|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.12||||0|TWO_SIDED|95.0|0.81|1.55|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.55|0.81|0.000
73926464|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.5||||0|TWO_SIDED|95.0|1.28|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.76|1.28|0.000
73926465|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.04||||0.202|TWO_SIDED|95.0|0.36|2.73|||Chi-squared|||Warfarin vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||2.73|0.36|0.202
73926466|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.28||||0|TWO_SIDED|95.0|1.15|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.43|1.15|0.000
73926467|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.95||||0.003|TWO_SIDED|95.0|0.86|1.06|||Chi-squared|||Warfarin vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||1.06|0.86|0.003
73926468|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.27||||0.083|TWO_SIDED|95.0|0.95|1.68|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.68|0.95|0.083
73926469|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|1.37||||0.011|TWO_SIDED|95.0|0.18|6.21|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||6.21|0.18|0.011
73926470|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.92||||0.227|TWO_SIDED|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.17|0.72|0.227
73926471|NCT03441633|147380227|SUPERIORITY||Odds Ratio (OR)|0.67||||0|TWO_SIDED|95.0|0.5|0.87|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||0.87|0.50|0.000
74087345|NCT00418522|147728726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26||||0.5684||95.0|-10.4|18.92|||ANCOVA|||Triglycerides at Week 26.||18.92|-10.40|0.5684
74087346|NCT00418522|147728727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.5673||95.0|-0.58|1.06|||ANCOVA|||hs-CRP at Week 26.||1.06|-0.58|0.5673
74087347|NCT00418522|147728727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.6099||95.0|-2.97|1.75|||ANCOVA|||Leptin at Week 26.||1.75|-2.97|0.6099
74087348|NCT00418522|147728727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.28||||0.7684||95.0|-12.94|17.51|||ANCOVA|||Spot urine microalbumin at Week 26.||17.51|-12.94|0.7684
74087349|NCT00418522|147728728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.5005||95.0|-0.69|1.42|||ANCOVA|||Adiponectin at Week 26.||1.42|-0.69|0.5005
73862469|NCT05160766|147270681|OTHER||Difference of means in percent|4.552|STANDARD_ERROR_OF_MEAN|10.801||0.67576|TWO_SIDED|95.0|-17.295|26.399|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617.3."|26.399|-17.295|0.67576
73862470|NCT05160766|147270681|OTHER||Difference of means in percent|8.438|STANDARD_ERROR_OF_MEAN|11.168||0.45443|TWO_SIDED|95.0|-14.15|31.027|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.526.1 (iota)."|31.027|-14.15|0.45443
73862471|NCT05160766|147270681|OTHER||Difference of means in percent|8.901|STANDARD_ERROR_OF_MEAN|10.218||0.38904|TWO_SIDED|95.0|-11.768|29.569|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2+L452M (omicron)."|29.569|-11.768|0.38904
73862472|NCT05160766|147270681|OTHER||Difference of means in percent|7.302|STANDARD_ERROR_OF_MEAN|10.11||0.47466|TWO_SIDED|95.0|-13.147|27.751|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2+L452R (omicron)."|27.751|-13.147|0.47466
73862473|NCT05160766|147270681|OTHER||Difference of means in percent|2.878|STANDARD_ERROR_OF_MEAN|9.824||0.7711|TWO_SIDED|95.0|-16.993|22.749|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.12.1 (omicron)."|22.749|-16.993|0.77110
73862474|NCT05160766|147270681|OTHER||Difference of means in percent|1.753||||0.86646|TWO_SIDED|95.0|-19.195|22.701|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.75 (omicron)."|22.701|-19.195|0.86646
73862475|NCT05160766|147270681|OTHER||Difference of means in percent|5.42|STANDARD_ERROR_OF_MEAN|9.705||0.57972|TWO_SIDED|95.0|-14.21|25.049|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.75.2 (omicron)."|25.049|-14.21|0.57972
73926472|NCT03441633|147380228|SUPERIORITY||Odds Ratio (OR)|0.68||||0|TWO_SIDED|95.0|0.61|0.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants||0.75|0.61|0.000
73926473|NCT03441633|147380228|SUPERIORITY||Odds Ratio (OR)|0.85||||0.052|TWO_SIDED|95.0|0.63|1.15|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants||1.15|0.63|0.052
73926474|NCT03441633|147380228|SUPERIORITY||Odds Ratio (OR)|0.73||||0|TWO_SIDED|95.0|0.67|0.8|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants||0.80|0.67|0.000
73926475|NCT03441633|147380228|SUPERIORITY||Odds Ratio (OR)|0.79||||0.052|TWO_SIDED|95.0|0.61|1.03|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants||1.03|0.61|0.052
73926476|NCT03441633|147380228|SUPERIORITY||Odds Ratio (OR)|1.26||||0|TWO_SIDED|95.0|1.17|1.36|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants||1.36|1.17|0.000
73926477|NCT03441633|147380228|SUPERIORITY||Odds Ratio (OR)|0.74||||0.052|TWO_SIDED|95.0|0.45|1.27|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants||1.27|0.45|0.052
74087350|NCT00418522|147728728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.685||95.0|-0.03|0.04|||ANCOVA|||ApoB at Week 26.||0.04|-0.03|0.6850
73926478|NCT03441633|147380228|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.95|1.21|||Chi-squared|||Warfarin vs. Apixaban in naive participants||1.21|0.95|0.000
73926479|NCT03441633|147380228|SUPERIORITY||Odds Ratio (OR)|0.57||||0.052|TWO_SIDED|95.0|0.4|0.84|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants||0.84|0.40|0.052
73926480|NCT03441633|147380229|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0|TWO_SIDED|95.0|-0.26|-0.17|||ANOVA|||Dabigatran vs. Apixaban in naive participants (HAS - BLED)||-0.17|-0.26|0.000
74087351|NCT00418522|147728729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.7||||0.1856||95.0|-43.37|160.77|||ANCOVA|||||160.77|-43.37|0.1856
74087352|NCT00418522|147728730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.72||||0.1862||95.0|-51.34|13.89|||ANCOVA|||||13.89|-51.34|0.1862
74087353|NCT00418522|147728736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.0055||95.0|0.35|2.04|||ANCOVA|||||2.04|0.35|0.0055
73862476|NCT05160766|147270681|OTHER||Difference of means in percent|1.17|STANDARD_ERROR_OF_MEAN|9.408||0.90166|TWO_SIDED|95.0|-17.859|20.199|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.3 (omicron)."|20.199|-17.859|0.90166
73862477|NCT05160766|147270681|OTHER||Difference of means in percent|1.018|STANDARD_ERROR_OF_MEAN|10.44||0.92279|TWO_SIDED|95.0|-20.099|22.136|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BF.7 (omicron)."|22.136|-20.099|0.92279
73862478|NCT05160766|147270681|OTHER||Difference of means in percent|3.532|STANDARD_ERROR_OF_MEAN|9.496||0.71191|TWO_SIDED|95.0|-15.675|22.74|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BQ.1 (omicron)."|22.74|-15.675|0.71191
73862479|NCT05160766|147270681|OTHER||Difference of means in percent|2.995|STANDARD_ERROR_OF_MEAN|8.755||0.73415|TWO_SIDED|95.0|-14.714|20.703|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BQ.1.1 (omicron)."|20.703|-14.714|0.73415
73862480|NCT05160766|147270681|OTHER||Difference of means in percent|7.157|STANDARD_ERROR_OF_MEAN|9.548||0.45798|TWO_SIDED|95.0|-12.155|26.469|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant XBB.1 (omicron)."|26.469|-12.155|0.45798
73862481|NCT05160766|147270681|OTHER||Difference of means in percent|4.819|STANDARD_ERROR_OF_MEAN|4.055||0.23582|TWO_SIDED|95.0|-3.169|12.808|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.2 (gamma)."|12.808|-3.169|0.23582
73862482|NCT05160766|147270681|OTHER||Difference of means in percent|5.312|STANDARD_ERROR_OF_MEAN|4.074||0.19354|TWO_SIDED|95.0|-2.713|13.337|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617."|13.337|-2.713|0.19354
73862483|NCT05160766|147270681|OTHER||Difference of means in percent|5.714|STANDARD_ERROR_OF_MEAN|4.155||0.17033|TWO_SIDED|95.0|-2.471|13.899|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617.1 (kappa)."|13.899|-2.471|0.17033
73926481|NCT03441633|147380229|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.001|TWO_SIDED|95.0|-0.18|-0.01|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (HAS - BLED)||-0.01|-0.18|0.001
73926482|NCT03441633|147380229|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0|TWO_SIDED|95.0|-0.23|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (HAS - BLED)||-0.15|-0.23|0.000
73926483|NCT03441633|147380229|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.001|TWO_SIDED|95.0|-0.19|-0.04|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (HAS - BLED)||-0.04|-0.19|0.001
74029121|NCT00859898|147612528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.3401|<|0.0001|TWO_SIDED|95.0|-2.64|-1.3||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-1.30|-2.64|<0.0001
74029122|NCT00859898|147612528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3362|<|0.0001|TWO_SIDED|95.0|-2.03|-0.71||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate||Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.71|-2.03|<0.0001
74029123|NCT02487745|147612604|SUPERIORITY||Odds Ratio (OR)|2.29||||0.05|TWO_SIDED|95.0|||||Regression, Logistic|||||||.05
74087354|NCT00418522|147728737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.0053||95.0|0.12|0.71|||ANCOVA|||||0.71|0.12|0.0053
74087355|NCT00418522|147728739|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.27|||<|0.0001||95.0|-0.47|-0.08|||ANCOVA||A CI approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.||-0.08|-0.47|<0.0001
74087356|NCT00418522|147728739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0062||95.0|-0.47|-0.08|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).||-0.08|-0.47|0.0062
74087357|NCT02695719|147728740|SUPERIORITY||Median Values of CI|1.0||||0.007|TWO_SIDED|95.0|0.1|1.9||No adjustment was made as there was only one primary comparison.|Van Elteren Test|The Van Elteren test is a stratified version of the Wilcoxon-Mann-Whitney test which provides approximate sample size for the van Elteren analysis.|CI was estimated by inverting the hypothesis test.|Assuming equal allocation, a power of 90%, an alpha level of 0.05 for a 2-sided test, a placebo mean of 4 (standard deviation of 2.7), and a treatment mean of 5.9 (standard deviation of 4) for SBM frequency at Week 1 and using Wilcoxon-Mann-Whitney test, a total sample size of 146 is required. Analysis was conducted using van Elteren test.||1.9|0.1|0.007
74087358|NCT00483548|147728747|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.36|STANDARD_ERROR_OF_MEAN|1.37||0.7921||95.0|-3.07|2.34||Due to planned interim analysis of primary endpoint, to control type I error at 2-sided alpha=0.05, a nominal 2-sided p-value ≤0.0476 needed at final analysis to reject the null hypothesis of no treatment effect.|ANCOVA Mixed-effects repeated-measures|No other adjustment made for multiple comparisons since all comparisons, except for single primary comparison, are considered secondary.|Mixed-effects repeated-measures (MMRM) analysis of covariance model: fixed categorical effects of treatment, country, mood stabilizer type, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.|N=141 per arm (282 total) needed for 85% power for 2-sided alpha=0.05 based on true mean difference=4.0 and standard deviation (SD)=11.0 for primary endpoint. Interim Analysis (IA) planned when 60% of subjects had completed study or discontinued prematurely to assess efficacy (nominal 2-sided p-value less than or equal to \[≤\] 0.0076) or futility (nominal 2-sided p-value greater than or equal to \[≥\] 0.5099).||2.34|-3.07|0.7921
74087359|NCT00483548|147728748|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.7223||95.0|-0.25|0.36|||ANCOVA Mixed-effects repeated-measures|||Week 6; MMRM analysis of covariance model with fixed categorical effects of treatment, country, type of mood stabilizer, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.||0.36|-0.25|0.7223
74087360|NCT00483548|147728749|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.846||||0.5029||95.0|0.52|1.38|||Regression, Logistic||Odds ratio measures the odds of achieving remission (MADRS total score ≤ 12) from ziprasidone treated subjects versus placebo; a value \> 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.38|0.52|0.5029
74087361|NCT00483548|147728750|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.949||||0.8266||95.0|0.59|1.52|||Regression, Logistic||Odds ratio measures the odds of achieving response (≥ 50 % reduction in MADRS total score) from ziprasidone treated subjects versus placebo; a value \> 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.52|0.59|0.8266
74087362|NCT00483548|147728751|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.939||||0.7924||95.0|0.59|1.5||Logistic regression model with treatment, country, and type of mood stabilizer.|Regression, Logistic|||Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.50|0.59|0.7924
73926484|NCT03441633|147380229|SUPERIORITY||Mean Difference (Final Values)|0.5||||0|TWO_SIDED|95.0|0.47|0.53|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (HAS - BLED)||0.53|0.47|0.000
74029124|NCT02487745|147612605|SUPERIORITY||Odds Ratio (OR)|3.88||||0.05|TWO_SIDED|95.0|||||Regression, Logistic|||||||.05
74029125|NCT05232097|147612616|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: the median of differences of the rumination score before and after therapy equals 0.||||0.005
74029126|NCT05232097|147612617|OTHER|||||||0.11|||||||Chi-squared|||The null hypothesis is that the same number of patients has intragastric pressure peaks indicating rumination before and after therapy.||||0.11
74029127|NCT05232097|147612618|OTHER|||||||0.06|||||||t-test, 2 sided|||Null hypothesis: The differences of means of 15D before and after therapy equals 0.||||0.060
74029128|NCT05232097|147612619|OTHER|||||||0.865|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The median of differences of WHODAS 2.0 before and after therapy equals 0.||||0.865
74029129|NCT05232097|147612620|OTHER|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis : the differences of median BDI before and after behavioral therapy equals 0.||||0.149
74029130|NCT05232097|147612621|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The differences of median of BAI before and after behavioral therapy equals 0.||||1.000
73862484|NCT05160766|147270681|OTHER||Difference of means in percent|5.934|STANDARD_ERROR_OF_MEAN|3.997||0.13895|TWO_SIDED|95.0|-1.94|13.808|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant AY.3 (delta)."|13.808|-1.94|0.13895
73926485|NCT03441633|147380229|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.001|TWO_SIDED|95.0|-0.32|-0.02|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (HAS - BLED)||-0.02|-0.32|0.001
73926486|NCT03441633|147380229|SUPERIORITY||Mean Difference (Final Values)|0.17||||0|TWO_SIDED|95.0|0.12|0.23|||ANOVA|||Warfarin vs. Apixaban in naive participants (HAS - BLED)||0.23|0.12|0.000
73926487|NCT03441633|147380229|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (HAS - BLED)||-0.10|-0.37|0.001
73926488|NCT03441633|147380230|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0|TWO_SIDED|95.0|-0.24|-0.12|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHADS2)||-0.12|-0.24|0.000
73969107|NCT05492318|147477026|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|71.43|||||TWO_SIDED|90.0|58.67|86.98||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||86.98|58.67|
73969108|NCT05492318|147477026|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.94|||||TWO_SIDED|90.0|58.82|83.15||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||83.15|58.82|
73926489|NCT03441633|147380230|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0|TWO_SIDED|95.0|-0.35|-0.12|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHADS2)||-0.12|-0.35|0.000
73926490|NCT03441633|147380230|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0|TWO_SIDED|95.0|-0.28|-0.18|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHADS2)||-0.18|-0.28|0.000
73926491|NCT03441633|147380230|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0|TWO_SIDED|95.0|-0.31|-0.11|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHADS2)||-0.11|-0.31|0.000
73926492|NCT03441633|147380230|SUPERIORITY||Mean Difference (Final Values)|0.21||||0|TWO_SIDED|95.0|0.17|0.25|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHADS2)||0.25|0.17|0.000
73969109|NCT05492318|147477026|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|72.3|||||TWO_SIDED|90.0|59.92|87.25||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||87.25|59.92|
73969110|NCT05492318|147477027|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|107.55|||||TWO_SIDED|90.0|103.35|111.49||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV: AUC0-inf||111.49|103.35|
73969111|NCT05492318|147477027|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|112.17|||||TWO_SIDED|90.0|106.21|118.46||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-inf||118.46|106.21|
73969112|NCT05492318|147477027|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|124.01|||||TWO_SIDED|90.0|119.44|128.76||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-inf||128.76|119.44|
74029131|NCT05232097|147612622|OTHER|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The differences of median weight before and after therapy equals 0.||||0.102
73926493|NCT03441633|147380230|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0|TWO_SIDED|95.0|-0.7|-0.3|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHADS2)||-0.30|-0.70|0.000
74029132|NCT01327339|147612628|SUPERIORITY_OR_OTHER||percentage of participants|5.9|||||TWO_SIDED|95.0|4.3|7.8|||||The estimated value represents the percentage of participants with an adverse event.|||7.8|4.3|
73926494|NCT03441633|147380230|SUPERIORITY||Mean Difference (Final Values)|0.08||||0|TWO_SIDED|95.0|0.01|0.14|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHADS2)||0.14|0.01|0.000
73926495|NCT03441633|147380230|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0|TWO_SIDED|95.0|-0.54|-0.2|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHADS2)||-0.20|-0.54|0.000
73926496|NCT03441633|147380231|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0|TWO_SIDED|95.0|-0.42|-0.26|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.26|-0.42|0.000
73926497|NCT03441633|147380231|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0|TWO_SIDED|95.0|-0.46|-0.19|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.19|-0.46|0.000
73926498|NCT03441633|147380231|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0|TWO_SIDED|95.0|-0.45|-0.32|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.32|-0.45|0.000
73926499|NCT03441633|147380231|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0|TWO_SIDED|95.0|-0.39|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.15|-0.39|0.000
74029133|NCT01847547|147612644|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||||95.0|0.64|1.7|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.70|0.64|
74087363|NCT00483548|147728752|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.68|STANDARD_ERROR_OF_MEAN|0.89||0.0594||95.0|-3.42|0.07|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.07|-3.42|0.0594
73862485|NCT05160766|147270681|OTHER||Difference of means in percent|4.222|STANDARD_ERROR_OF_MEAN|3.812||0.26924|TWO_SIDED|95.0|-3.288|11.732|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant AY.4.2 (delta)."|11.732|-3.288|0.26924
74087364|NCT00483548|147728752|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.25|STANDARD_ERROR_OF_MEAN|1.03||0.223||95.0|-3.27|0.77|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.77|-3.27|0.2230
74087365|NCT00483548|147728752|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.43|STANDARD_ERROR_OF_MEAN|1.09||0.6971||95.0|-2.57|1.72|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.72|-2.57|0.6971
74087366|NCT00483548|147728752|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.68|STANDARD_ERROR_OF_MEAN|1.12||0.5485||95.0|-2.89|1.54|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.54|-2.89|0.5485
74087367|NCT00483548|147728752|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.25|STANDARD_ERROR_OF_MEAN|1.19||0.8322||95.0|-2.6|2.1|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.10|-2.60|0.8322
74087368|NCT00483548|147728753|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.1771||95.0|-0.29|0.05|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.29|0.1771
74087369|NCT00483548|147728753|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1765||95.0|-0.37|0.07|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.07|-0.37|0.1765
74087370|NCT00483548|147728753|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6765||95.0|-0.27|0.18|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.18|-0.27|0.6765
74087371|NCT00483548|147728753|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.977||95.0|-0.24|0.25|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.25|-0.24|0.9770
74087372|NCT00483548|147728753|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7907||95.0|-0.3|0.23|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.23|-0.30|0.7907
74087373|NCT00483548|147728754|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0392||95.0|-0.43|-0.01|||ANOVA|||Week 1; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||-0.01|-0.43|0.0392
74087374|NCT00483548|147728754|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2803||95.0|-0.38|0.11|||ANOVA|||Week 2; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.11|-0.38|0.2803
74087375|NCT00483548|147728754|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.9835||95.0|-0.26|0.26|||ANOVA|||Week 3; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.26|-0.26|0.9835
74087376|NCT00483548|147728754|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.06|STANDARD_ERROR_OF_MEAN|0.15||0.7062||95.0|-0.34|0.23|||ANOVA|||Week 4; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.23|-0.34|0.7062
74087377|NCT00483548|147728754|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.01|STANDARD_ERROR_OF_MEAN|0.15||0.9518||95.0|-0.31|0.29|||ANOVA|||Week 5; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.29|-0.31|0.9518
73926500|NCT03441633|147380231|SUPERIORITY||Mean Difference (Final Values)|0.19||||0|TWO_SIDED|95.0|0.14|0.24|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHA2DS2Vasc)||0.24|0.14|0.000
74087378|NCT00483548|147728754|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.4757||95.0|-0.2|0.42||Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.|ANOVA|||Week 6; LOCF||0.42|-0.20|0.4757
74087379|NCT00483548|147728755|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.35|STANDARD_ERROR_OF_MEAN|0.75||0.6362||95.0|-1.12|1.82|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.82|-1.12|0.6362
74087380|NCT00483548|147728755|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.59|STANDARD_ERROR_OF_MEAN|0.8||0.4565||95.0|-0.98|2.17|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.17|-0.98|0.4565
74087381|NCT00483548|147728755|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.61|STANDARD_ERROR_OF_MEAN|0.86||0.477||95.0|-1.08|2.3|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.30|-1.08|0.4770
74087382|NCT00483548|147728756|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.7|STANDARD_ERROR_OF_MEAN|0.46||0.1277||95.0|-0.2|1.6|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.60|-0.20|0.1277
74087383|NCT00483548|147728756|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.64|STANDARD_ERROR_OF_MEAN|0.53||0.2345||95.0|-0.41|1.68|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.68|-0.41|0.2345
74087384|NCT00483548|147728756|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.13|STANDARD_ERROR_OF_MEAN|0.6||0.8337||95.0|-1.05|1.3|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.30|-1.05|0.8337
74087385|NCT00483548|147728756|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.43|STANDARD_ERROR_OF_MEAN|0.59||0.4646||95.0|-0.73|1.59|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.59|-0.73|0.4646
74087386|NCT00483548|147728756|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.5|STANDARD_ERROR_OF_MEAN|0.59||0.3993||95.0|-0.67|1.67|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.67|-0.67|0.3993
74087387|NCT00483548|147728756|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.19|STANDARD_ERROR_OF_MEAN|0.65||0.7647||95.0|-1.08|1.46|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.46|-1.08|0.7647
73862486|NCT05160766|147270681|OTHER||Difference of means in percent|5.49|STANDARD_ERROR_OF_MEAN|3.996||0.1708|TWO_SIDED|95.0|-2.382|13.362|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617.3."|13.362|-2.382|0.17080
73862487|NCT05160766|147270681|OTHER||Difference of means in percent|5.567|STANDARD_ERROR_OF_MEAN|4.188||0.18502|TWO_SIDED|95.0|-2.683|13.818|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.526.1 (iota)."|13.818|-2.683|0.18502
73862488|NCT05160766|147270681|OTHER||Difference of means in percent|3.438|STANDARD_ERROR_OF_MEAN|3.938||0.38344|TWO_SIDED|95.0|-4.318|11.195|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2+L452M (omicron)."|11.195|-4.318|0.38344
73862489|NCT05160766|147270681|OTHER||Difference of means in percent|3.279|STANDARD_ERROR_OF_MEAN|3.982||0.411|TWO_SIDED|95.0|-4.565|11.124|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2+L452R (omicron)."|11.124|-4.565|0.41100
73862490|NCT05160766|147270681|OTHER||Difference of means in percent|2.67|STANDARD_ERROR_OF_MEAN|4.014||0.5066|TWO_SIDED|95.0|-5.237|10.577|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.12.1 (omicron)."|10.577|-5.237|0.50660
73862491|NCT05160766|147270681|OTHER||Difference of means in percent|4.535|STANDARD_ERROR_OF_MEAN|4.242||0.28604|TWO_SIDED|95.0|-3.82|12.891|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.75 (omicron)."|12.891|-3.82|0.28604
73862492|NCT05160766|147270681|OTHER||Difference of means in percent|6.259|STANDARD_ERROR_OF_MEAN|3.98||0.11715|TWO_SIDED|95.0|-1.582|14.1|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.75.2 (omicron)."|14.1|-1.582|0.11715
73862493|NCT05160766|147270681|OTHER||Difference of means in percent|3.818|STANDARD_ERROR_OF_MEAN|3.957||0.33567|TWO_SIDED|95.0|-3.978|11.613|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.3 (omicron)."|11.613|-3.978|0.33567
73926501|NCT03441633|147380231|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0|TWO_SIDED|95.0|-0.86|-0.37|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.37|-0.86|0.000
73926502|NCT03441633|147380231|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0|TWO_SIDED|95.0|-0.18|-0.01|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.01|-0.18|0.000
73926503|NCT03441633|147380231|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0|TWO_SIDED|95.0|-0.64|-0.21|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.21|-0.64|0.000
73926504|NCT03441633|147380232|SUPERIORITY||Odds Ratio (OR)|1.88||||0.008|TWO_SIDED|95.0|0.77|5.3|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants||5.30|0.77|0.008
73926505|NCT03441633|147380232|SUPERIORITY||Odds Ratio (OR)|0.62||||0.008|TWO_SIDED|95.0|0.33|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants||1.12|0.33|0.008
74087388|NCT00483548|147728757|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|4.24|STANDARD_ERROR_OF_MEAN|1.65||0.0108||95.0|0.99|7.5|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||7.50|0.99|0.0108
73862494|NCT05160766|147270681|OTHER||Difference of means in percent|5.775|STANDARD_ERROR_OF_MEAN|4.022||0.15232|TWO_SIDED|95.0|-2.147|13.697|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BF.7 (omicron)."|13.697|-2.147|0.15232
73862495|NCT05160766|147270681|OTHER||Difference of means in percent|4.808|STANDARD_ERROR_OF_MEAN|3.845||0.21234|TWO_SIDED|95.0|-2.766|12.383|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BQ.1 (omicron)."|12.383|-2.766|0.21234
73862496|NCT05160766|147270681|OTHER||Difference of means in percent|4.58|STANDARD_ERROR_OF_MEAN|3.78||0.22687|TWO_SIDED|95.0|-2.866|12.026|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BQ.1.1 (omicron)."|12.026|-2.866|0.22687
73862497|NCT05160766|147270681|OTHER||Difference of means in percent|3.498|STANDARD_ERROR_OF_MEAN|4.047||0.38832|TWO_SIDED|95.0|-4.475|11.47|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant XBB.1 (omicron)."|11.47|-4.475|0.38832
73862498|NCT02853435|147270682|OTHER||Ratio of geometric LS means|1.0417|||||TWO_SIDED|90.0|0.9809|1.1063|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).|||1.1063|0.9809|
73862499|NCT02853435|147270682|OTHER||Ratio of geometric LS means|1.1108|||||TWO_SIDED|90.0|1.0459|1.1797|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).|||1.1797|1.0459|
73862500|NCT02853435|147270683|OTHER||Ratio of geometric LS means|1.0408|||||TWO_SIDED|90.0|0.9792|1.1062|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).|||1.1062|0.9792|
73862501|NCT02853435|147270683|OTHER||Ratio of geometric LS means|1.1138|||||TWO_SIDED|90.0|1.0479|1.1838|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).|||1.1838|1.0479|
73862502|NCT02853435|147270685|OTHER||Ratio of geometric LS means|0.9586|||||TWO_SIDED|90.0|0.844|1.0888|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.|||1.0888|0.8440|
73926506|NCT03441633|147380232|SUPERIORITY||Odds Ratio (OR)|0.55||||0.008|TWO_SIDED|95.0|0.2|1.99|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants||1.99|0.20|0.008
73926507|NCT03441633|147380232|SUPERIORITY||Odds Ratio (OR)|0.39||||0.008|TWO_SIDED|95.0|0.18|0.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants||0.86|0.18|0.008
73926508|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|1.41||||0|TWO_SIDED|95.0|1.14|1.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Poor adherence)||1.75|1.14|0.000
74087389|NCT00483548|147728758|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-4.56|STANDARD_ERROR_OF_MEAN|1.35||0.001||95.0|-7.24|-1.87|||ANCOVA|||Total SDS: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||-1.87|-7.24|0.0010
74087390|NCT00483548|147728759|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.44|STANDARD_ERROR_OF_MEAN|0.28||0.123|TWO_SIDED|95.0|-1.0|0.12|||ANCOVA|||Days Lost: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.12|-1.00|0.1230
74087391|NCT00483548|147728759|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.17|STANDARD_ERROR_OF_MEAN|0.34||0.6232|TWO_SIDED|95.0|-0.84|0.5|||ANCOVA|||Days Unproductive: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.50|-0.84|0.6232
74087392|NCT00483548|147728760|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0096||95.0|0.04|0.31|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.31|0.04|0.0096
74087393|NCT00483548|147728760|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.8134||95.0|-0.13|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.16|-0.13|0.8134
74087394|NCT00483548|147728760|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0226||95.0|0.02|0.29|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.29|0.02|0.0226
74087395|NCT00483548|147728761|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0193||95.0|0.02|0.23|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.23|0.02|0.0193
74087396|NCT00483548|147728761|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.4745||0.16|-0.07|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.16|-0.07|0.4745
74087397|NCT00483548|147728761|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.07|STANDARD_ERROR_OF_MEAN|0.06||0.2613||95.0|-0.05|0.19|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.19|-0.05|0.2613
74087398|NCT00483548|147728762|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0271||95.0|0.01|0.21|||ANCOVA|||Total score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.21|0.01|0.0271
74087399|NCT00483548|147728762|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7462||95.0|-0.07|0.05|||ANCOVA|||Total score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.07|0.7462
74087400|NCT00483548|147728762|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.9574||95.0|-0.08|0.08|||ANCOVA|||Total score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.08|-0.08|0.9574
74087401|NCT00483548|147728762|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0844||95.0|-0.01|0.1|||ANCOVA|||Global severity score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.10|-0.01|0.0844
74087402|NCT00483548|147728762|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.5779||95.0|-0.04|0.06|||ANCOVA|||Global severity score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.06|-0.04|0.5779
73926509|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.67||||0|TWO_SIDED|95.0|0.55|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Good adherence)||0.82|0.55|0.000
73926510|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.03|2.01|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Over adherence)||2.01|0.03|0.000
73926511|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|1.58||||0|TWO_SIDED|95.0|1.23|2.04|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Poor adherence)||2.04|1.23|0.000
73926512|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.44||||0|TWO_SIDED|95.0|0.34|0.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Good adherence)||0.57|0.34|0.000
73926513|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.43||||0|TWO_SIDED|95.0|0.02|3.73|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Over adherence)||3.73|0.02|0.000
73926514|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.66||||0|TWO_SIDED|95.0|0.52|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Poor adherence)||0.84|0.52|0.000
73926515|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|1.14||||0|TWO_SIDED|95.0|0.95|1.36|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Good adherence)||1.36|0.95|0.000
73926516|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.52||||0|TWO_SIDED|95.0|0.06|3.41|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Over adherence)||3.41|0.06|0.000
73926517|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.65||||0|TWO_SIDED|95.0|0.5|0.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Poor adherence)||0.85|0.50|0.000
73926518|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|1.11||||0|TWO_SIDED|95.0|0.9|1.37|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Good adherence)||1.37|0.90|0.000
73926519|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.22|5.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Over adherence)||5.85|0.22|0.000
74087403|NCT00483548|147728762|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7455||95.0|-0.05|0.06|||ANCOVA|||Global severity score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.06|-0.05|0.7455
73862503|NCT02853435|147270685|OTHER||Ratio of geometric LS means|1.1487|||||TWO_SIDED|90.0|1.0113|1.3047|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.|||1.3047|1.0113|
73862504|NCT02853435|147270686|OTHER||Median Difference (Final Values)|-0.233||||0.309|TWO_SIDED|90.0|-0.267|0.0||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.|||0.000|-0.267|0.309
73862505|NCT02853435|147270686|OTHER||Median Difference (Final Values)|-0.492|||<|0.001|TWO_SIDED|90.0|-0.5|-0.25||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.|||-0.250|-0.500|<0.001
73862506|NCT00996801|147270793|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.96||||0.012|TWO_SIDED|95.0|-3.58|-0.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.35|-3.58|0.012
73862507|NCT00996801|147270793|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.81||||0.019|TWO_SIDED|95.0|-3.37|-0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.25|-3.37|0.019
73926520|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|3.37||||0|TWO_SIDED|95.0|2.86|3.99|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Poor adherence)||3.99|2.86|0.000
73969113|NCT05492318|147477027|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|134.29|||||TWO_SIDED|90.0|126.15|142.96||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV. AUC0-inf||142.96|126.15|
73926521|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.11||||0|TWO_SIDED|95.0|0.09|0.13|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Good adherence)||0.13|0.09|0.000
73926522|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.34||||0|TWO_SIDED|95.0|0.11|1.52|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Over adherence)||1.52|0.11|0.000
73926523|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|1.23||||0|TWO_SIDED|95.0|0.78|1.91|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Poor adherence)||1.91|0.78|0.000
73969114|NCT05492318|147477027|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|138.75|||||TWO_SIDED|90.0|129.05|149.18||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-inf||149.18|129.05|
74029134|NCT01847547|147612645|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||||95.0|0.69|1.36|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.36|0.69|
74029135|NCT01847547|147612646|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||||95.0|0.62|2.45|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.45|0.62|
74029136|NCT01847547|147612647|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||||95.0|0.15|0.59|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.59|0.15|
74087404|NCT00483548|147728762|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3278||95.0|-0.02|0.05|||ANCOVA|||Incapacitation score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.02|0.3278
73862508|NCT00996801|147270793|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.82||||0.019|TWO_SIDED|95.0|-3.23|-0.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.41|-3.23|0.019
73862509|NCT00996801|147270794|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.64|||<|0.001|TWO_SIDED|95.0|-3.9|-1.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.38|-3.90|<0.001
73862510|NCT00996801|147270794|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.62|||<|0.001|TWO_SIDED|95.0|-3.83|-1.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.40|-3.83|<0.001
73862511|NCT00996801|147270794|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.12|||<|0.001|TWO_SIDED|95.0|-3.22|-1.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.02|-3.22|<0.001
73926524|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.01||||0|TWO_SIDED|95.0|0.0|0.09|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Good adherence)||0.09|0.00|0.000
73926525|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|2.07||||0|TWO_SIDED|95.0|0.07|18.0|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Over adherence)||18.00|0.07|0.000
73926526|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.58||||0|TWO_SIDED|95.0|0.45|0.75|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Poor adherence)||0.75|0.45|0.000
73926527|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.51||||0|TWO_SIDED|95.0|0.41|0.63|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Good adherence)||0.63|0.41|0.000
74087405|NCT00483548|147728762|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9097||95.0|-0.03|0.03|||ANCOVA|||Incapacitation score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.03|-0.03|0.9097
73926528|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|29.4||||0|TWO_SIDED|95.0|11.01|123.8|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Over adherence)||123.80|11.01|0.000
73926529|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|1.31||||0|TWO_SIDED|95.0|0.91|1.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Poor adherence)||1.86|0.91|0.000
73926530|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.05|0.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Good adherence)||0.17|0.05|0.000
73926531|NCT03441633|147380233|SUPERIORITY||Odds Ratio (OR)|9.73||||0|TWO_SIDED|95.0|2.81|46.5|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Over adherence)||46.50|2.81|0.000
73926532|NCT03441633|147380234|SUPERIORITY||Odds Ratio (OR)|1.08||||0|TWO_SIDED|95.0|0.92|1.27|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Discontinuation first year)||1.27|0.92|0.000
74087406|NCT00483548|147728762|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9864||95.0|-0.04|0.04|||ANCOVA|||Incapacitation score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.04|-0.04|0.9864
74087407|NCT00483548|147728763|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|1.52|STANDARD_ERROR_OF_MEAN|2.54||0.5519||95.0|-3.5|6.53|||ANCOVA|||Total Q-LES-Q: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||6.53|-3.50|0.5519
74087408|NCT00483548|147728763|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.5238||95.0|-0.35|0.18|||ANCOVA|||Medications: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.18|-0.35|0.5238
73862512|NCT00996801|147270794|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.74||||0.376|TWO_SIDED|95.0|-1.99|0.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.52|-1.99|0.376
73926533|NCT03441633|147380234|SUPERIORITY||Odds Ratio (OR)|1.45||||0|TWO_SIDED|95.0|1.15|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Discontinuation first year)||1.83|1.15|0.000
73926534|NCT03441633|147380234|SUPERIORITY||Odds Ratio (OR)|1.09||||0|TWO_SIDED|95.0|0.93|1.27|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Discontinuation first year)||1.27|0.93|0.000
73926535|NCT03441633|147380234|SUPERIORITY||Odds Ratio (OR)|1.18||||0|TWO_SIDED|95.0|0.96|1.47|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Discontinuation first year)||1.47|0.96|0.000
74087409|NCT00483548|147728763|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.09|STANDARD_ERROR_OF_MEAN|0.14||0.536||95.0|-0.19|0.36|||ANCOVA|||Overall life satisfaction: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.36|-0.19|0.5360
73862513|NCT00996801|147270794|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.71||||0.376|TWO_SIDED|95.0|-1.93|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.50|-1.93|0.376
74087410|NCT00868296|147728798|SUPERIORITY_OR_OTHER|||||||0.857||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in length z-score.||||0.857
74087411|NCT00868296|147728798|SUPERIORITY_OR_OTHER|||||||0.901||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in weight z-score.||||0.901
74087412|NCT00868296|147728798|SUPERIORITY_OR_OTHER|||||||0.807||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in head circumference z-score.||||0.807
73926536|NCT03441633|147380234|SUPERIORITY||Odds Ratio (OR)|0.89||||0|TWO_SIDED|95.0|0.79|1.01|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Discontinuation first year)||1.01|0.79|0.000
73926537|NCT03441633|147380234|SUPERIORITY||Odds Ratio (OR)|4.82||||0|TWO_SIDED|95.0|3.14|7.55|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Discontinuation first year)||7.55|3.14|0.000
74087413|NCT00868296|147728798|SUPERIORITY_OR_OTHER|||||||0.595|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.||||0.595
74087414|NCT00868296|147728798|SUPERIORITY_OR_OTHER|||||||0.016|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.||||0.016
74087415|NCT00868296|147728798|SUPERIORITY_OR_OTHER|||||||0.347|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.||||0.347
74087416|NCT00868296|147728798|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.||||0.040
74087417|NCT00868296|147728798|SUPERIORITY_OR_OTHER|||||||0.892|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.||||0.892
74087418|NCT00868296|147728798|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.||||0.006
74087419|NCT00573170|147728805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.378|TWO_SIDED|95.0|0.7|2.5||Compares odds ratio.|Generalized Estimating Equations|||||2.5|0.7|0.378
74029137|NCT01847547|147612648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||||95.0|0.15|0.67|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.||0.67|0.15|
74029138|NCT01847547|147612649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27||||||95.0|0.09|0.84|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.84|0.09|
74029139|NCT01847547|147612650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||||95.0|0.78|2.01|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.01|0.78|
74029140|NCT01847547|147612652|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||||95.0|0.48|1.14|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.14|0.48|
74087420|NCT03476317|147728837|EQUIVALENCE|Median difference in calprotectin for controls from day 12 to baseline||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
74087421|NCT01439724|147728899|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.158||||0.05|TWO_SIDED|95.0|0.05|0.498|||Chi-squared|||The primary end point of the study was the incidence of grade 3-4 oral mucositis (OM) according to the WHO scale. Assuming an α =0.05 and a β = 0.20, with the estimates of proportion being 0.40 for placebo (P0) and 0.15 for LLLT (P1) a total of 94 patients were evaluated. One-sided test error was the basis for the sample size determination and all the reported P-values were derived from two-sided statistical tests. P-values less than or equal to 0.05 were considered statistically significant.||0.498|0.050|0.05
74087422|NCT04019054|147728904|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group.||||||0.518|||||||ANOVA|||||||0.518
74087423|NCT04019054|147728905|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Analysis described here is within-group differences.||||||0.008||||||a priori threshold for significance of p=0.05. Observed power η2=0.39.|ANOVA|||||||0.008
74087424|NCT04019054|147728905|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Analysis described here is between-group differences.|||||>|0.05||||||a priori threshold for significance of p=0.05.|ANOVA|||||||>0.05
74029141|NCT01847547|147612653|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||||95.0|0.47|2.2|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.20|0.47|
74087425|NCT04019054|147728906|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Result described here is within-group difference over time.||||||0.004||||||a priori threshold for significance p=0.05. Result above describes within group testing over time. Observed power η2=0.43.|ANOVA|||||||0.004
74087426|NCT04019054|147728906|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Result described here is the between-group comparison|||||>|0.05||||||a priori threshold for significance p=0.05|ANOVA|||||||>0.05
74087427|NCT04019054|147728907|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.01||||||Threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of skin conductance level (SCL) as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<0.01
74087428|NCT04019054|147728907|SUPERIORITY|||||||0.029||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||The second statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of skin conductance level (SCL) (as a function of step and timepoint).||||0.029
74087429|NCT04019054|147728908|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
74087430|NCT04019054|147728908|SUPERIORITY|||||||0.63||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of step and timepoint.||||0.63
74029142|NCT01847547|147612654|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||||95.0|0.21|1.98|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.98|0.21|
74029143|NCT01847547|147612655|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||||95.0|0.5|1.08|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.08|0.50|
74029144|NCT01847547|147612656|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||||95.0|0.21|0.76|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.76|0.21|
74029145|NCT01847547|147612657|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.58|1.55|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.55|0.58|
74029146|NCT01847547|147612658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||||95.0|0.32|5.72|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||5.72|0.32|
74029147|NCT01847547|147612659|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||||95.0|0.83|3.08|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||3.08|0.83|
74029148|NCT01847547|147612660|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||||95.0|0.57|3.7|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||3.70|0.57|
74029149|NCT01847547|147612661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.67|1.35|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.||1.35|0.67|
74029150|NCT01847547|147612662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||||95.0|0.79|2.01|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.01|0.79|
74087431|NCT04019054|147728908|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance of p=0.05|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of treatment group and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
74087432|NCT04019054|147728908|SUPERIORITY||||||<|0.001||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of group and timepoint.||||<0.001
74029151|NCT01158950|147612670|SUPERIORITY|||||||0.032||||||The threshold for statistical significance was set to p \< 0.05.|Fisher transformation|||The comparison group represents the difference in ICR and the baseline impulsiveness scale.||||0.032
74029152|NCT01158950|147612671|SUPERIORITY||||||<|0.05||||||The threshold is set to p \< 0.05, corrected for multiple comparisons.|Fisher transformation|Statistical tests are computed across multiple subregions (voxels) within each area. Thus, the correlation coefficient above is a summary score.||||||< 0.05
74029153|NCT00510692|147612674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06||||0.005|TWO_SIDED|95.0|-1.78|-0.35|||ANCOVA|||||-0.35|-1.78|0.005
74029154|NCT01845077|147612679|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||TWO_SIDED|90.0|95.3|103.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.5|95.3|
74029155|NCT01845077|147612679|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|101.5|||||TWO_SIDED|90.0|98.4|104.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||One patient was excluded from this analysis due to the lack of the 72h sample for the L+M1000 fed treatment.||104.7|98.4|
74029156|NCT01845077|147612679|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|100.9|||||TWO_SIDED|90.0|98.2|103.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.7|98.2|
74029157|NCT01845077|147612680|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|94.9|||||TWO_SIDED|90.0|86.8|103.6|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.6|86.8|
74029158|NCT01845077|147612680|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||TWO_SIDED|90.0|90.2|103.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.8|90.2|
74029159|NCT01845077|147612680|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|108.6||||||90.0|99.5|118.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||118.5|99.5|
74029160|NCT01845077|147612681|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.7|||||TWO_SIDED|90.0|97.1|110.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||110.8|97.1|
74029161|NCT01845077|147612681|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|105.3|||||TWO_SIDED|90.0|99.9|111.0|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||111.0|99.9|
74029162|NCT01845077|147612681|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||TWO_SIDED|90.0|90.2|104.1|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||104.1|90.2|
74029163|NCT01845077|147612682|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||TWO_SIDED|90.0|86.8|108.2|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||108.2|86.8|
74087433|NCT04019054|147728908|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of step and group. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
73862514|NCT00996801|147270794|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.22||||0.699|TWO_SIDED|95.0|-1.32|0.88||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.88|-1.32|0.699
73926538|NCT03441633|147380234|SUPERIORITY||Odds Ratio (OR)|1.41||||0|TWO_SIDED|95.0|1.19|1.67|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Discontinuation first year)||1.67|1.19|0.000
74087434|NCT04019054|147728908|SUPERIORITY|||||||0.047||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of step and group.||||0.047
74087435|NCT04019054|147728909|SUPERIORITY||Mann Whitney U statistic|13.5|STANDARD_ERROR_OF_MEAN|9.58||0.027|TWO_SIDED|||||a priori threshold for significance of p=0.05|Wilcoxon (Mann-Whitney)|||2-sided Mann-Whitney U Test (nonparametric) utilized to compare the ability of the groups to tolerate treatment intensity.||||0.027
74029164|NCT01845077|147612682|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.7|||||TWO_SIDED|90.0|96.1|103.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.5|96.1|
74029165|NCT01845077|147612682|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|95.9|||||TWO_SIDED|90.0|86.7|106.0|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||106.0|86.7|
74029166|NCT01845077|147612683|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||TWO_SIDED|90.0|86.6|108.2|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||108.2|86.6|
74029167|NCT01845077|147612683|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.4|||||TWO_SIDED|90.0|95.6|103.4|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.4|95.6|
73926539|NCT03441633|147380234|SUPERIORITY||Odds Ratio (OR)|2.92||||0|TWO_SIDED|95.0|2.12|4.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Discontinuation first year)||4.05|2.12|0.000
73926540|NCT03441633|147380235|SUPERIORITY||Mean Difference (Final Values)|3.63||||0|TWO_SIDED|95.0|3.02|4.24|||ANOVA|||Dabigatran vs. Apixaban in naive participants (NDDDs)||4.24|3.02|0.000
73926541|NCT03441633|147380235|SUPERIORITY||Mean Difference (Final Values)|0.11||||0|TWO_SIDED|95.0|-0.77|0.98|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (NDDDs)||0.98|-0.77|0.000
73926542|NCT03441633|147380235|SUPERIORITY||Mean Difference (Final Values)|1.51||||0|TWO_SIDED|95.0|0.84|2.17|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (NDDDs)||2.17|0.84|0.000
73926543|NCT03441633|147380235|SUPERIORITY||Mean Difference (Final Values)|1.98||||0|TWO_SIDED|95.0|1.16|2.8|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (NDDDs)||2.80|1.16|0.000
73926544|NCT03441633|147380235|SUPERIORITY||Mean Difference (Final Values)|0.9||||0|TWO_SIDED|95.0|0.41|1.39|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (NDDDs)||1.39|0.41|0.000
73926545|NCT03441633|147380235|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0|TWO_SIDED|95.0|-4.32|-0.18|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (NDDDs)||-0.18|-4.32|0.000
73926546|NCT03441633|147380235|SUPERIORITY||Mean Difference (Final Values)|28.52||||0|TWO_SIDED|95.0|27.56|29.48|||ANOVA|||Warfarin vs. Apixaban in naive participants (NDDDs)||29.48|27.56|0.000
73926547|NCT03441633|147380235|SUPERIORITY||Mean Difference (Final Values)|1.93||||0|TWO_SIDED|95.0|-1.05|4.9|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (NDDDs)||4.90|-1.05|0.000
73926548|NCT02872116|147380238|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|98.4|0.59|0.86|||Log Rank|||||0.86|0.59|<0.0001
74029168|NCT01845077|147612683|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||TWO_SIDED|90.0|90.1|109.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||109.5|90.1|
74029169|NCT01845077|147612684|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.5|||||TWO_SIDED|90.0|84.8|109.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||109.8|84.8|
74087436|NCT04019054|147728911|OTHER|A pair of chi-square analyses were performed to validate blinding of the study (based on questionnaires completed by subjects and raters). Given the small sample size, Fisher's exact method was utilized. The number of correct and incorrect guesses for each group were examined once for the subject guesses and once for the rater's guesses.|||||>|0.05|||||||Fisher Exact|For the subjects, p=0.64 using Fisher's exact method. For the raters, p=1 using Fisher's exact method.||||||>.05
74087437|NCT04019054|147728912|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
73926549|NCT02872116|147380239|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|98.0|0.56|0.81|||Log Rank|||||0.81|0.56|<0.0001
73926550|NCT03089606|147380271|OTHER|2-tailed Fisher's exact test||||||0.08|||||||2-tailed Fisher's exact test|||Null hypothesis. No association between baseline C11-AMT PET SUVmax value and antitumor response to pembrolizumab.||||0.08
73926551|NCT02486042|147380313|OTHER|T-test for equality in means. The p-value threshold for significance was p \< 0.05.||||||0.22|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T0 blood samples in the Standard of Care versus Omegaven group||||0.22
73926552|NCT02486042|147380313|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.15|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T0 blood samples in the Standard of Care versus Omegaven group||||0.15
73926553|NCT02486042|147380313|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.78|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T0 blood samples in the Standard of Care versus Omegaven group||||0.78
73926554|NCT02486042|147380317|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.43|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T1 blood samples in the Standard of Care versus Omegaven group||||0.43
73926555|NCT02486042|147380317|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.44|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T1 blood samples in the Standard of Care versus Omegaven group||||0.44
73926556|NCT02486042|147380317|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.5|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T1 blood samples in the Standard of Care versus Omegaven group||||0.50
73926557|NCT02486042|147380318|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.001|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T2 blood samples in the Standard of Care versus Omegaven group||||0.001
73926558|NCT02486042|147380318|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.001|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T2 blood samples in the Standard of Care versus Omegaven group||||0.001
73926559|NCT02486042|147380318|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.01|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T2 blood samples in the Standard of Care versus Omegaven group||||0.01
74029170|NCT01845077|147612684|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.2|||||TWO_SIDED|90.0|98.9|107.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||107.7|98.9|
73862515|NCT00996801|147270795|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.04||||0.002|TWO_SIDED|95.0|-3.43|-0.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.64|-3.43|0.002
73862516|NCT00996801|147270795|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.29||||0.035|TWO_SIDED|95.0|-2.48|-0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.09|-2.48|0.035
73862517|NCT00996801|147270795|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.76||||0.009|TWO_SIDED|95.0|-3.14|-0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.38|-3.14|0.009
73862518|NCT00996801|147270795|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.86||||0.335|TWO_SIDED|95.0|-2.26|0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.54|-2.26|0.335
73862519|NCT00996801|147270795|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.11||||0.857|TWO_SIDED|95.0|-1.3|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.08|-1.30|0.857
73862520|NCT00996801|147270795|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.59||||0.542|TWO_SIDED|95.0|-1.96|0.79||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.79|-1.96|0.542
73862521|NCT00996801|147270796|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.24|||<|0.001|TWO_SIDED|95.0|-4.91|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.57|-4.91|<0.001
73926560|NCT02530450|147380320|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Testing the change between two time points within each group using Wilcoxon signed rank test.||||< 0.05
73926561|NCT00566150|147380322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|TWO_SIDED|95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.||||0.29
73926562|NCT00566150|147380323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|TWO_SIDED|95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.||||0.07
73926563|NCT00566150|147380324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||Statistical significance was p\<0.05|Fisher Exact|Fisher's exact test was used to test for significance between groups.||Week 6||||.038
73926564|NCT00566150|147380325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79||95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups.||||0.79
74087438|NCT04019054|147728912|SUPERIORITY||||||>|0.05||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of step and timepoint.||||>.05
73862522|NCT00996801|147270796|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.18|||<|0.001|TWO_SIDED|95.0|-4.78|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.57|-4.78|<0.001
73862523|NCT00996801|147270796|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.2|||<|0.001|TWO_SIDED|95.0|-4.66|-1.74||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.74|-4.66|<0.001
73862524|NCT00996801|147270796|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.27||||0.18|TWO_SIDED|95.0|-2.93|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.40|-2.93|0.180
73862525|NCT00996801|147270796|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.2||||0.18|TWO_SIDED|95.0|-2.81|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.40|-2.81|0.180
73862526|NCT00996801|147270796|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.22||||0.18|TWO_SIDED|95.0|-2.68|0.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.23|-2.68|0.180
73862527|NCT00996801|147270797|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.36||||0.001|TWO_SIDED|95.0|-2.18|-0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.54|-2.18|0.001
73926565|NCT00788827|147380346|OTHER||||||<|0.05|||||||Mixed Models Analysis|||Each participants Hba1c (%) lab result was analysed pre and post stem cell infusion to achieve 2 mean readings per participant.||||<0.05
73969115|NCT05492318|147477027|OTHER||GMR corresponds to the ratio of the Geom|134.18|||||TWO_SIDED|90.0|124.19|144.97||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: AUC0-inf||144.97|124.19|
73969116|NCT05492318|147477027|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|162.76|||||TWO_SIDED|90.0|151.13|175.28||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: AUC0-inf||175.28|151.13|
73969117|NCT05492318|147477027|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|161.2|||||TWO_SIDED|90.0|147.8|175.82||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-inf||175.82|147.80|
74087439|NCT04019054|147728912|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance of p=0.05|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of treatment group and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
74087440|NCT04019054|147728912|SUPERIORITY||||||<|0.001||||||a priori threshold for significance of p=0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of group and timepoint.||||<.001
74087441|NCT04019054|147728912|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of step and group. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
74087442|NCT04019054|147728912|SUPERIORITY|||||||0.024||||||a priori threshold for significance of p=0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of step and group.||||0.024
74087443|NCT03877926|147728922|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 1 and Lot 2 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.01|||||TWO_SIDED|95.0|0.93|1.1||||||||1.10|0.93|
74087444|NCT03877926|147728922|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 1 and Lot 3 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.05|||||TWO_SIDED|95.0|0.96|1.14||||||||1.14|0.96|
74087445|NCT03877926|147728922|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 2 and Lot 3 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.04|||||TWO_SIDED|95.0|0.95|1.13||||||||1.13|0.95|
73969118|NCT05492318|147477028|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.96|||||TWO_SIDED|90.0|58.83|83.2||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||83.20|58.83|
74087446|NCT03877926|147728924|OTHER||Percentage of participants|66.3|||||TWO_SIDED|95.0|64.5|68.1||||||||68.1|64.5|
74087447|NCT03877926|147728925|NON_INFERIORITY|A non-inferiority margin of -15% was used for the difference in percentage of AV7909 participants (pooled from three AV7909 study groups \[Lot 1, 2, and 3\]) vs. BioThrax participants who achieved TNA NF50 ≥0.29 at Day 64. The success criterion was defined as the lower bound of 95% confidence interval of the difference in the percentage of AV7909 vs. BioThrax participants being greater than -15%.|Difference in percentage|24.5|||||TWO_SIDED|95.0|20.0|29.2||||||||29.2|20.0|
73969119|NCT05492318|147477028|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|71.65|||||TWO_SIDED|90.0|59.08|86.88||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||86.88|59.08|
73969120|NCT05492318|147477028|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|70.37|||||TWO_SIDED|90.0|59.64|83.03||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||83.03|59.64|
73969121|NCT05492318|147477028|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|73.45|||||TWO_SIDED|90.0|60.79|88.75||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate. AUC0-inf||88.75|60.79|
74087448|NCT03877926|147728926|OTHER|Relative risk of serious adverse events incidence between AV7909 (combined from all three AV7909 lots) and BioThrax.|Relative risk (AV7909/BioThrax)|2.5|||||TWO_SIDED|95.0|0.9|6.5|||||The 95% CI of the relative risk was derived using the Farrington-Manning relative risk score statistic.|||6.5|0.9|
74087449|NCT03877926|147728927|OTHER|Success criteria was defined as the lower bound for the 95% CI for the proportion of participants pooled from all three AV7909 study groups with TNA NF50 ≥0.15 to be ≥67%.|Percentage of participants|97.8|||||TWO_SIDED|95.0|97.2|98.3||||||||98.3|97.2|
74087450|NCT03877926|147728929|OTHER|Relative risk of adverse events of special interest (events of autoimmune etiology) incidence between AV7909 (combined from all three AV7909 lots) and BioThrax.|Relative risk (AV7909/BioThrax)|1.3|||||TWO_SIDED|95.0|0.3|5.0|||||The 95% CI of the relative risk was derived using the Farrington-Manning relative risk score statistic.|||5.0|0.3|
74087451|NCT02240186|147728935|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
73969122|NCT04282148|147477136|SUPERIORITY||||||<|0.0001|||||||Z test using Kaplan Meier survival estim|||||||<0.0001
73969123|NCT03524612|147477165|OTHER||||||<|0.0001|||||||Clopper Pearson test|||||||<0.0001
73969124|NCT04770532|147477189|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin degludec) was strictly below 0.3%.|Treatment difference|-0.22|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.08|||ANCOVA|||The response and change from baseline in response after 26 weeks were analysed using an analysis of covariance (ANCOVA) model with treatment, region and personal continuous glucose monitoring (CGM) device use as fixed factors, and baseline response as covariate.||-0.08|-0.37|<0.0001
74087452|NCT02240186|147728936|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
73862528|NCT00996801|147270797|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.51||||0.001|TWO_SIDED|95.0|-2.46|-0.55||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.55|-2.46|0.001
73862529|NCT00996801|147270797|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.92|||<|0.001|TWO_SIDED|95.0|-2.93|-0.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.91|-2.93|<0.001
73862530|NCT00996801|147270797|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.37||||0.383|TWO_SIDED|95.0|-1.21|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.46|-1.21|0.383
73862531|NCT00996801|147270797|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.52||||0.383|TWO_SIDED|95.0|-1.49|0.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.45|-1.49|0.383
73862532|NCT00996801|147270797|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.94||||0.084|TWO_SIDED|95.0|-1.96|0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.09|-1.96|0.084
73969125|NCT05457647|147477201|OTHER|The accuracy and precision of the theranostic imaging biomarkers, including both the riboflavin score and theranostic score, to predict CXL treatment outcome were determined by calculating the proportion of correctly classified eyes and the positive predictive value respectively.|Proportion|91.0|||||TWO_SIDED|95.0|||||||The study set a minimum threshold of 85 for the the combined use of the theranostic imaging biomarkers' accuracy and precision in predicting the propensity of CXL to halt disease progression at 1 year in the study population.|Accuracy and precision of the combined use of theranostic imaging biomarkers generated by the UV-A device to predict the propensity of CXL in flattening the Kmax value at 12-months.||||
73862533|NCT00996801|147270798|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.47||||0.68|TWO_SIDED|95.0|-1.88|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.94|-1.88|0.680
73862534|NCT00996801|147270798|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.01||||0.993|TWO_SIDED|95.0|-1.3|1.28||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.28|-1.30|0.993
73862535|NCT00996801|147270798|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.1||||0.23|TWO_SIDED|95.0|-2.67|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.46|-2.67|0.230
74087453|NCT02240186|147728937|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
74087454|NCT00860743|147728955|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|ANOVA|||||||0.001
73862536|NCT00996801|147270798|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.84||||0.333|TWO_SIDED|95.0|-2.29|0.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.61|-2.29|0.333
73862537|NCT00996801|147270798|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.37||||0.577|TWO_SIDED|95.0|-1.69|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.94|-1.69|0.577
73862538|NCT00996801|147270798|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.47||||0.078|TWO_SIDED|95.0|-3.07|0.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.12|-3.07|0.078
73862539|NCT00996801|147270799|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.99||||0.094|TWO_SIDED|95.0|-4.22|0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.25|-4.22|0.094
73862540|NCT00996801|147270799|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.66||||0.157|TWO_SIDED|95.0|-3.82|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.50|-3.82|0.157
73862541|NCT00996801|147270799|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.57||||0.157|TWO_SIDED|95.0|-3.53|0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.38|-3.53|0.157
73862542|NCT00996801|147270799|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.43||||0.937|TWO_SIDED|95.0|-2.61|1.76||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.76|-2.61|0.937
74087455|NCT00860743|147728956|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||||||0.2
74087456|NCT02776553|147728959|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||0.49
74087457|NCT02776553|147728960|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
74087458|NCT02776553|147728961|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
73969126|NCT05457647|147477202|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of Kmax value at 12-months follow-up visit.||||<0.05
73969127|NCT05457647|147477203|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of ECD value at 12-months follow-up visit.||||<0.05
73969128|NCT05457647|147477204|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of MSER value at 12-months follow-up visit.||||<0.05
73969129|NCT05457647|147477205|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of CDVA value at 12-months follow-up visit.||||<0.05
73969130|NCT05457647|147477206|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of UDVA value at 12-months follow-up visit.||||<0.05
73969131|NCT05457647|147477207|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of CCT value at 12-months follow-up visit.||||<0.05
73969132|NCT05457647|147477208|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively. Bonferroni correction was applied to analysis of exploratory outcome measures of stratification groups.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73969133|NCT04938492|147477209|SUPERIORITY||Slope|2.08|||>|0.05|TWO_SIDED||||||Latent growth modeling|||||||>.05
73969134|NCT04938492|147477210|SUPERIORITY||Slope|0.19|||<|0.001|TWO_SIDED||||||Latent growth modeling|||||||<.001
73969135|NCT04938492|147477211|SUPERIORITY||Slope|0.22|||<|0.01|TWO_SIDED||||||Latent growth modeling|||||||<.01
73969136|NCT04938492|147477212|SUPERIORITY||Slope|0.23|||>|0.05|TWO_SIDED||||||Latent growth modeling|||||||>.05
73969137|NCT02683447|147477213|OTHER|Correlation||||||0.039||||||P \< 0.05 is considered statistically significant.|Pearson correlation|||||||0.039
73969138|NCT02683447|147477214|OTHER|Correlation|||||<|0.01||||||P \< 0.05 is considered statically significant.|Pearson correlation|||ACLS correct score||||<0.01
73969139|NCT02683447|147477214|OTHER|Correlation||||||0.322||||||P \< 0.05 is considered statically significant.|Pearson correlation|||ACLS risk score||||0.322
73969140|NCT02921230|147477250|SUPERIORITY|||||||0.0077|||||||Chi-squared|||||||0.0077
73969141|NCT02143726|147477281|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0918|TWO_SIDED|95.0|0.23|1.33|||Log Rank|Stratified 1-sided log-rank test (stratified by ECOG performance status, prior systemic treatment for hürthle thyroid cancer, and treating site).||||1.33|0.23|0.0918
73969142|NCT02143726|147477283|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.3976|TWO_SIDED|95.0|0.53|4.96|||Log Rank|||||4.96|0.53|0.3976
73969143|NCT03953508|147477308|OTHER|Analysis of covariance test|||||>|0.05||||||Threshold for significance is p\<.05|ANCOVA|||||||>.05
73969144|NCT03953508|147477309|OTHER|T-test comparing differences, the null hypothesis is that the groups are equal|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
73969145|NCT03953508|147477310|OTHER|Analysis of variance test comparing average breakpoint for menthol and non-menthol smokers|||||<|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||<.05
73969146|NCT03953508|147477311|OTHER|T-test|||||<|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||<.05
73969147|NCT03953508|147477312|OTHER|Analysis of variance|||||>|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||>.05
73969148|NCT03953508|147477313|OTHER|Analysis of variance|||||<|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||<.05
73969149|NCT03953508|147477314|OTHER|T-test|||||<|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||<.05
73969150|NCT03953508|147477315|OTHER|Fisher's exact test|||||>|0.05||||||Threshold for significance is p\<.05|Fisher Exact|||||||>.05
74087459|NCT01056640|147728969|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31|STANDARD_ERROR_OF_MEAN|0.2865||0.05|TWO_SIDED|95.0|0.747|2.297|||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test, 2-sample t-test and Chi-square analysis were all used.||All analyses were performed using an intent-to-treat method. Wilcoxon rank sum test, 2-sample t test, or Chi-Square analysis was used to compare baseline characteristics. The primary end points of combined and individual percentages of hospitalizations and ED visits were compared using Chi-Square test. Statistical adjustment was planned only if there were statistical differences in clinical variables between the groups. All tests for significance used a 2-sided P value of .05.||2.297|0.747|0.05
74087460|NCT04740931|147728978|NON_INFERIORITY|If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.5|1.6|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. The final sample size provided \>90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).||1.6|-2.5|
74087461|NCT04740931|147728978|SUPERIORITY||Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|1.04||0.6715|TWO_SIDED|95.0|-2.5|1.6||Tested at a two-sided p\<0.0497 significance level.|Mixed Model of Repeated Measures||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The final sample size provided \>80% power for a 3.5-letter superiority assessment of faricimab over aflibercept (at a two-sided 0.0497 significance level).||1.6|-2.5|0.6715
74087462|NCT04740931|147728980|OTHER||Difference in CMH Weighted Percentage|-1.5|||||TWO_SIDED|95.0|-8.4|5.3||||||||5.3|-8.4|
74087463|NCT04740931|147728996|OTHER||Difference in Adjusted Means|-1.2|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.7|0.3||||||||0.3|-2.7|
74087464|NCT01043926|147729035|NON_INFERIORITY_OR_EQUIVALENCE|"AUC(0-∞) GMR = AUC(0-∞) GM for Moderate Hepatic Insufficiency Participants ÷ AUC(0-∞) GM for Healthy Participants~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the AUC(0-∞) GMR fell below 2.00, then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.74|1.43|||ANCOVA|||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."||1.43|0.74|
73969151|NCT03953508|147477316|OTHER|T-test|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
73969152|NCT03953508|147477317|OTHER|T-test|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
73862543|NCT00996801|147270799|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.1||||0.992|TWO_SIDED|95.0|-2.21|2.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.01|-2.21|0.992
73969153|NCT02100813|147477322|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.31|||<|0.001|TWO_SIDED|95.0|0.23|0.42|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.42|0.23|<0.001
73969154|NCT02100813|147477322|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.18|0.33|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.33|0.18|<0.001
73969155|NCT02100813|147477322|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.79|||=|0.096|TWO_SIDED|95.0|0.59|1.04|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||1.04|0.59|=0.096
73969156|NCT02100813|147477323|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|7.02|||=|0.007|TWO_SIDED|95.0|1.53|124.0|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||124|1.53|=0.007
73969157|NCT02100813|147477323|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|8.82|||=|0.001|TWO_SIDED|95.0|1.99|154.5|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||154.5|1.99|=0.001
73969158|NCT02100813|147477323|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|1.26|||=|0.43|TWO_SIDED|95.0|0.72|2.31|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.31|0.72|=0.43
73969159|NCT02100813|147477324|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|8.73|||<|0.001|TWO_SIDED|95.0|2.93|51.66|||Log binomial regression|||||51.66|2.93|<0.001
73969160|NCT02100813|147477324|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|9.55|||<|0.001|TWO_SIDED|95.0|3.22|56.4|||Log binomial regression|||||56.4|3.22|<0.001
73969161|NCT02100813|147477324|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|1.09|||=|0.55|TWO_SIDED|95.0|0.81|1.49|||Log binomial regression|||||1.49|0.81|=0.55
73969162|NCT04856163|147477331|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
73969163|NCT04856163|147477332|SUPERIORITY|||||||0.21|||||||discrete-time survival model|||||||0.21
73969164|NCT04856163|147477333|SUPERIORITY|||||||0.28|||||||Regression, Logistic|||||||0.28
73969165|NCT04856163|147477334|SUPERIORITY|||||||0.05|||||||Regression, Linear|||||||0.05
73926566|NCT01527682|147380351|OTHER||Proportion|76.7|||||TWO_SIDED|95.0|64.1|89.4|||||||The statistical analysis was performed according to study design. Using a Fleming single stage design (A'Hern approach) setting the probability of erroneously concluding that the responders rate is greater than 35% at 5% (one-sided alpha=0.05) and the probability of correctly concluding that the responders rate is at least 50% at 80% (beta error = 0.20), the minimum number of responder eyes was set at 31 out of 68, since this result is associated with a lower limit of the 90% exact confidence interval of 35.2%.|89.4|64.1|
73926567|NCT01586819|147380354|SUPERIORITY||Z score|-3.3902||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have lower scores on the facial wrinkle severity scale post-treatment.||||.002
73969166|NCT03158714|147477357|SUPERIORITY||Mean Difference (Net)|0.033||||0.005|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.005
73969167|NCT03158714|147477357|SUPERIORITY||Mean Difference (Net)|0.02||||0.101|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.101
73926568|NCT01586819|147380355|SUPERIORITY||Z score|3.6115||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have higher difference scores, pre- to post-treatment, on the facial wrinkle severity scale suggesting a more pronounced effect of the chemical peel in combination with the Botox A therapy.||||.001
73926569|NCT03979638|147380367|SUPERIORITY||Estimated percent change|-10.8||||0.1424|TWO_SIDED|95.0|-23.5|4.0|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||4.0|-23.5|0.1424
73969168|NCT03158714|147477358|SUPERIORITY||Mean Difference (Net)|3.96|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Regression, Linear|Utilized multi-level modeling to account for nested data (individuals within couples), and controlled for baseline levels of outcome in regression.||||||< .001
73969169|NCT03158714|147477358|SUPERIORITY||Mean Difference (Net)|4.09|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Regression, Linear|Utilized multi-level modeling to account for nested data (individuals within couples), and controlled for baseline levels of outcome in regression.||||||< .001
74087465|NCT01043926|147729036|NON_INFERIORITY_OR_EQUIVALENCE|"Cmax GMR = Cmax GM for Moderate Hepatic Insufficiency Participants ÷ Cmax GM for Healthy Participants~A 90% CI for the Cmax GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the Cmax GMR fell below 2.00, then the hypothesis would be met and the Cmax of suvorexant would be similar in both groups of participants. That is, if the true ratio of the geometric mean Cmax is no more than 2.00."|Cmax Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.68|1.29|||ANCOVA|||"The GM for each participant group and the corresponding 95% CI were calculated for Cmax using an ANCOVA model.~The Cmax GMR of the 2 participant groups was used to test the primary hypothesis, which was that the Cmax of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."||1.29|0.68|
74087466|NCT00104247|147729053|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74087467|NCT02598895|147729054|OTHER|||||||||||||||||The primary efficacy endpoint was percent patients achieving PSA decline of 50% or more from baseline (PSA50), assessed in the time prior to disease progression, unacceptable toxicity or 1 year after the last study medication. The historical comparison was PSA50 of 26%. The target response rate was 60%. The study followed an optimal two-stage Simon design (Simon, 1989) where the null hypothesis that the true PSA response rate PSA50 was 0.26 was tested against a one-sided alternative.|See above|||
74087468|NCT01192399|147729066|OTHER||||||<|0.0001|||||||Sign test|||||||<0.0001
74087469|NCT00784134|147729142|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.027||||0.554|TWO_SIDED|95.0|-0.062|0.115|||Chi-squared|||||0.115|-0.062|0.554
74087470|NCT00784134|147729142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.465|TWO_SIDED|95.0|0.75|1.87||Multivariable logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume.|Multivariable Logit Model|||||1.87|0.75|0.465
74087471|NCT00784134|147729143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.484|TWO_SIDED|95.0|0.63|1.25||Generalized ordered logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical) compares odds ratio for mRS score \> K v. \<= K for K = 1 - 4; Alt v. Sal.|Generalized ordered Logit Model|||||1.25|0.63|0.484
74087472|NCT00784134|147729143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.71||The same generalized ordered logit model, adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical), compares odds ratio for mRS score greater than 5 versus mRS score equal or less than 5 (dead versus alive).|Generalized ordered Logit Model|||||0.71|0.28|<0.001
74087473|NCT00784134|147729144|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.026||||0.552|TWO_SIDED|95.0|-0.059|0.111|||Chi-squared|||||0.111|-0.059|0.552
74087474|NCT00784134|147729144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.35|TWO_SIDED|95.0|0.8|1.9||Multivariable logit model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Multivariable Logit Model|||||1.90|0.80|0.350
74087475|NCT00784134|147729145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.428|TWO_SIDED|95.0|0.78|1.8||Random effects model with site as random effect adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Random Effects Model|||||1.80|0.78|0.428
74087476|NCT00784134|147729146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.384|TWO_SIDED|95.0|0.75|2.1|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 30 days||2.10|0.75|0.384
74087477|NCT00784134|147729146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.964|TWO_SIDED|95.0|0.62|1.64|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 180 days||1.64|0.62|0.964
74087478|NCT00784134|147729147|SUPERIORITY_OR_OTHER|||||||0.0056|||||||Log Rank|||||||0.0056
74087479|NCT00784134|147729148|SUPERIORITY_OR_OTHER||||||<|0.001|||||||AUC/ Logit Model|||||||<0.001
74087480|NCT00784134|147729149|SUPERIORITY_OR_OTHER|||||||0.771|||||||Kruskal-Wallis|||||||0.771
73926570|NCT03979638|147380367|SUPERIORITY||Estimated percent change|-6.1||||0.4602|TWO_SIDED|95.0|-20.8|11.2|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||11.2|-20.8|0.4602
73926571|NCT03979638|147380367|SUPERIORITY||Estimated percent change|-7.8||||0.4181|TWO_SIDED|95.0|-24.4|12.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||12.5|-24.4|0.4181
73926572|NCT03979638|147380367|SUPERIORITY||Estimated percent change|-16.7||||0.0855|TWO_SIDED|95.0|-32.3|2.6|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||2.6|-32.3|0.0855
74087481|NCT00784134|147729150|SUPERIORITY_OR_OTHER|||||||0.098|||||||Kruskal-Wallis|||||||0.098
74087482|NCT00784134|147729151|SUPERIORITY_OR_OTHER|||||||0.45|||||||Generalized Linear Models|||||||0.450
74087483|NCT00784134|147729152|SUPERIORITY_OR_OTHER|||||||0.501|||||||Chi-squared|||||||0.501
74087484|NCT00784134|147729153|SUPERIORITY_OR_OTHER|||||||0.795|||||||Chi-squared|||||||0.795
74087485|NCT00784134|147729154|SUPERIORITY_OR_OTHER|||||||0.784|||||||Chi-squared|||||||0.784
74087486|NCT00784134|147729155|SUPERIORITY_OR_OTHER|||||||0.592|||||||Chi-squared|||||||0.592
74087487|NCT00784134|147729156|SUPERIORITY_OR_OTHER|||||||0.105|||||||Chi-squared|||||||0.105
74087488|NCT00784134|147729157|SUPERIORITY_OR_OTHER|||||||0.152|||||||Chi-squared|||||||0.152
74087489|NCT00784134|147729158|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.055||||0.055|TWO_SIDED|95.0|-0.111|0.008|||Fisher Exact|||||0.008|-0.111|0.055
74087490|NCT00784134|147729159|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.035||||0.202|TWO_SIDED|95.0|-0.084|0.014|||Fisher Exact|||||0.014|-0.084|0.202
74087491|NCT00784134|147729160|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||0.771|TWO_SIDED|95.0|-0.022|0.03|||Fisher Exact|||||0.030|-0.022|0.771
74087492|NCT00784134|147729161|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||0.811|TWO_SIDED|95.0|-0.028|0.036|||Fisher Exact|||||0.036|-0.028|0.811
74087493|NCT00784134|147729162|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.144||||0.0017|TWO_SIDED|95.0|-0.23|-0.057|||Fisher Exact|||||-0.057|-0.230|0.0017
74087494|NCT00784134|147729163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.006|TWO_SIDED|95.0|0.41|0.86|||Cox Proportional Hazards Model|Adjusted Cox Proportional Hazards Model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||||0.86|0.41|0.006
74087495|NCT00784134|147729164|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.064||||0.41|TWO_SIDED|95.0|-0.088|0.217|||Chi-squared|||||0.217|-0.088|0.410
74087496|NCT00784134|147729165|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.016||||0.781|TWO_SIDED|95.0|-0.096|0.128|||Chi-squared|||||0.128|-0.096|0.781
74087497|NCT00784134|147729166|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.773|TWO_SIDED|95.0|-0.113|0.152|||Chi-squared|||||0.152|-0.113|0.773
74087498|NCT00784134|147729167|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.032||||0.587|TWO_SIDED|95.0|-0.085|0.151|||Chi-squared|||||0.151|-0.085|0.587
74087499|NCT00784134|147729168|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.015||||0.775|TWO_SIDED|95.0|-0.09|0.121|||Chi-squared|||||0.121|-0.09|0.775
74087500|NCT00784134|147729169|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.019||||0.808|TWO_SIDED|95.0|-0.132|0.169|||Chi-squared|||||0.169|-0.132|0.808
74087501|NCT00784134|147729170|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.033||||0.625|TWO_SIDED|95.0|-0.165|0.099|||Chi-squared|||||0.099|-0.165|0.625
74087502|NCT00784134|147729171|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.087||||0.191|TWO_SIDED|95.0|-0.043|0.218|||Chi-squared|||||0.218|-0.043|0.191
74087503|NCT00784134|147729172|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0066||||0.949|TWO_SIDED|95.0|-0.197|0.211|||Chi-squared|||||0.211|-0.197|0.949
74087504|NCT00784134|147729173|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.014||||0.812|TWO_SIDED|95.0|-0.098|0.126|||Chi-squared|||||0.126|-0.098|0.812
74087505|NCT00784134|147729174|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.059||||0.394|TWO_SIDED|95.0|-0.076|0.194|||Chi-squared|||||0.194|-0.076|0.394
74087506|NCT00784134|147729175|SUPERIORITY_OR_OTHER|||||||0.312|||||||Wilcoxon (Mann-Whitney)|||||||0.312
74087507|NCT00784134|147729176|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.075||||0.087|TWO_SIDED|95.0|-0.011|0.16||Analysis of dichotomous eGOS, comparing Upper Severe Disability scores to Lower Severe Disability scores|Chi-squared|||||0.160|-0.011|0.087
74087508|NCT00784134|147729176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.064|TWO_SIDED|95.0|0.98|2.43||Adjusted Multivariable Logit Model comparing eGOS scores of Upper Severe Disability or greater versus Lower Severe Disability and worse; Alteplase versus Saline|Multivariable Logit Model|||||2.43|0.98|0.064
74087509|NCT00784134|147729176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.336|TWO_SIDED|95.0|0.7|2.89||Adjusted generalized ordered logit model odds ratios for eGOS scores of Moderate Disability or worse versus Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model|||||2.89|0.70|0.336
74087510|NCT00784134|147729176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.783|TWO_SIDED|95.0|0.57|1.52||Adjusted generalized ordered logit model odds ratios for eGOS scores of Upper Severe Disability or worse versus Moderate Disability + Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model|||||1.52|0.57|0.783
74087511|NCT00784134|147729177|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
74087512|NCT00784134|147729178|SUPERIORITY_OR_OTHER|||||||0.312|||||||t-test, 2 sided|||||||0.312
74087513|NCT00784134|147729179|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
74087514|NCT00784134|147729180|SUPERIORITY_OR_OTHER|||||||0.478|||||||t-test, 2 sided|||||||0.478
74087515|NCT00784134|147729181|SUPERIORITY_OR_OTHER|||||||0.634|||||||t-test, 2 sided|||||||0.634
74087516|NCT00784134|147729182|SUPERIORITY_OR_OTHER|||||||0.255|||||||t-test, 2 sided|||||||0.255
73862544|NCT00996801|147270799|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.01||||0.992|TWO_SIDED|95.0|-1.93|1.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.90|-1.93|0.992
73862545|NCT00996801|147270800|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.47||||0.824|TWO_SIDED|95.0|-2.5|1.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.56|-2.50|0.824
73862546|NCT00996801|147270800|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.42||||0.824|TWO_SIDED|95.0|-2.28|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.43|-2.28|0.824
73862547|NCT00996801|147270800|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.96||||0.624|TWO_SIDED|95.0|-3.23|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.31|-3.23|0.624
73862548|NCT00996801|147270800|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.78||||0.7|TWO_SIDED|95.0|-1.25|2.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.82|-1.25|0.700
73862549|NCT00996801|147270800|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.83||||0.7|TWO_SIDED|95.0|-1.39|3.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.06|-1.39|0.700
73862550|NCT00996801|147270800|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.3||||0.759|TWO_SIDED|95.0|-1.6|2.19||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.19|-1.60|0.759
73862551|NCT00996801|147270801|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.22||||0.227|TWO_SIDED|95.0|-39.15|6.72||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||6.72|-39.15|0.227
73926573|NCT03979638|147380368|SUPERIORITY||Estimated percent change|-20.3||||0.001|TWO_SIDED|95.0|-29.9|-9.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-9.5|-29.9|0.0010
73926574|NCT03979638|147380368|SUPERIORITY||Estimated percent change|-17.7||||0.0186|TWO_SIDED|95.0|-29.9|-3.3|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-3.3|-29.9|0.0186
73926575|NCT03979638|147380368|SUPERIORITY||Estimated percent change|-19.4||||0.032|TWO_SIDED|95.0|-33.9|-1.9|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-1.9|-33.9|0.0320
73862552|NCT00996801|147270801|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.85||||0.853|TWO_SIDED|95.0|-17.9|21.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||21.61|-17.90|0.853
73862553|NCT00996801|147270801|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-13.14||||0.327|TWO_SIDED|95.0|-35.67|9.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||9.39|-35.67|0.327
73862554|NCT00996801|147270801|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.74||||0.94|TWO_SIDED|95.0|-23.91|18.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||18.43|-23.91|0.940
73862555|NCT00996801|147270801|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|15.33||||0.273|TWO_SIDED|95.0|-7.86|38.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||38.52|-7.86|0.273
73862556|NCT00996801|147270801|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.33||||0.973|TWO_SIDED|95.0|-19.23|19.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||19.90|-19.23|0.973
73862557|NCT00996801|147270802|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.48||||0.01|TWO_SIDED|95.0|-2.66|-0.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.29|-2.66|0.010
73926576|NCT03979638|147380368|SUPERIORITY||Estimated percent change|-27.0||||0.0026|TWO_SIDED|95.0|-40.3|-10.8|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-10.8|-40.3|0.0026
73926577|NCT03979638|147380369|SUPERIORITY||Estimated percent change|-28.1||||0.0005|TWO_SIDED|95.0|-39.5|-14.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-14.5|-39.5|0.0005
73926578|NCT03979638|147380369|SUPERIORITY||Estimated percent change|-28.4||||0.0003|TWO_SIDED|95.0|-39.7|-15.0|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-15.0|-39.7|0.0003
74087517|NCT00784134|147729183|SUPERIORITY_OR_OTHER|||||||0.224|||||||t-test, 2 sided|||||||0.224
74087518|NCT00784134|147729184|SUPERIORITY_OR_OTHER|||||||0.882|||||||t-test, 2 sided|||||||0.882
73926579|NCT03979638|147380369|SUPERIORITY||Estimated percent change|-29.5||||0.0014|TWO_SIDED|95.0|-42.7|-13.2|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-13.2|-42.7|0.0014
73926580|NCT03979638|147380369|SUPERIORITY||Estimated percent change|-32.4||||0.0006|TWO_SIDED|95.0|-45.3|-16.4|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-16.4|-45.3|0.0006
73926581|NCT02586896|147380378|SUPERIORITY|||||||0.29|||||||ANOVA|||||||0.29
73926582|NCT02586896|147380380|SUPERIORITY|||||||0.91|||||||ANOVA|||||||0.91
73926583|NCT02586896|147380381|SUPERIORITY|||||||0.09|||||||ANOVA|||||||0.09
73926584|NCT02586896|147380382|SUPERIORITY|||||||0.54|||||||ANOVA|||||||0.54
73926585|NCT00851799|147380440|SUPERIORITY_OR_OTHER||Difference in annual rate of change|-4.7||||0.013|TWO_SIDED|97.5|-8.9|-0.4||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort C: DRV/RTV + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||-0.4|-8.9|0.013
73926586|NCT00851799|147380440|SUPERIORITY_OR_OTHER||Difference in annual rate of change|-2.8||||0.15|TWO_SIDED|97.5|-7.0|1.5||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||1.5|-7.0|0.15
73926587|NCT00851799|147380440|SUPERIORITY_OR_OTHER||Difference in annual rate of change|1.9||||0.31|TWO_SIDED|97.5|-2.4|6.2||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort C: DRV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||6.2|-2.4|0.31
73926588|NCT00851799|147380441|SUPERIORITY_OR_OTHER||Difference in Change|0.24||||0.53|TWO_SIDED|97.5|-0.63|1.11||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort A: ATV/RTV+FTC/TDF - Cohort C: DRV/RTV+FTC/TDF); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||1.11|-0.63|0.53
73969170|NCT03158714|147477359|SUPERIORITY||Mean Difference (Net)|0.343||||0.003|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.003
74087519|NCT00784134|147729185|SUPERIORITY_OR_OTHER|||||||0.551|||||||t-test, 2 sided|||||||0.551
74087520|NCT00784134|147729186|SUPERIORITY_OR_OTHER|||||||0.224|||||||t-test, 2 sided|||||||0.224
74087521|NCT00784134|147729187|SUPERIORITY_OR_OTHER|||||||0.376|||||||t-test, 2 sided|||||||0.376
74087522|NCT03346070|147729221|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.0075|TWO_SIDED|95.0|1.18|3.1|||Log Rank||Cox regression model|||3.10|1.18|0.0075
73926589|NCT00851799|147380441|SUPERIORITY_OR_OTHER||Difference in Change (%)|-0.21||||0.53|TWO_SIDED|97.5|-0.98|0.55||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort B - Cohort A and C); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||0.55|-0.98|0.53
74087523|NCT03346070|147729221|SUPERIORITY||Hazard Ratio (HR)|25.9|||<|0.0001|TWO_SIDED|95.0|9.72|69.03|||Log Rank||Cox regression model|||69.03|9.72|<0.0001
74087524|NCT03346070|147729221|SUPERIORITY||Hazard Ratio (HR)|61.4|||<|0.0001|TWO_SIDED|95.0|14.13|266.77|||Log Rank||Cox regression model|||266.77|14.13|<0.0001
74087525|NCT03346070|147729221|SUPERIORITY||Hazard Ratio (HR)|2.38||||0.0005|TWO_SIDED|95.0|1.44|3.93|||Log Rank||Cox regression model|||3.93|1.44|0.0005
74087526|NCT03346070|147729221|SUPERIORITY||Hazard Ratio (HR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.5|3.01|||Log Rank||Cox regression model|||3.01|1.50|<0.0001
74087527|NCT03346070|147729222|SUPERIORITY||Difference in percentage|2.3||||0.602|TWO_SIDED|95.0|-9.6|15.0|||Miettinen & Nurminen method|||||15.0|-9.6|0.602
74087528|NCT03346070|147729222|SUPERIORITY||Difference in percentage|0.2||||0.969|TWO_SIDED|95.0|-13.4|13.5|||Miettinen & Nurminen method|||||13.5|-13.4|0.969
74087529|NCT03346070|147729222|SUPERIORITY||Difference in percentage|2.6||||0.567|TWO_SIDED|95.0|-8.7|15.0|||Miettinen & Nurminen method|||||15.0|-8.7|0.567
74087530|NCT03346070|147729222|SUPERIORITY||Difference in percentage|2.6||||0.571|TWO_SIDED|95.0|-8.8|15.0|||Miettinen & Nurminen method|||||15.0|-8.8|0.571
74087531|NCT03346070|147729222|SUPERIORITY||Difference in percentage|-0.2||||0.95|TWO_SIDED|95.0|-11.6|10.9|||Miettinen & Nurminen method|||||10.9|-11.6|0.950
74087532|NCT03346070|147729222|SUPERIORITY||Difference in percentage|2.9||||0.528|TWO_SIDED|95.0|-8.4|15.9|||Miettinen & Nurminen method|||||15.9|-8.4|0.528
73926590|NCT04365556|147380485|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance is p\<.05|ANCOVA|||||||<0.001
73926591|NCT04365556|147380486|SUPERIORITY|||||||0.69|||||||ANCOVA|||||||0.69
74087533|NCT03346070|147729222|SUPERIORITY||Difference in percentage|1.3||||0.709|TWO_SIDED|95.0|-6.8|9.6|||Miettinen & Nurminen method|||||9.6|-6.8|0.709
74087534|NCT03346070|147729223|SUPERIORITY||Difference in percentage|2.2||||0.738|TWO_SIDED|95.0|-12.3|17.4|||Miettinen & Nurminen method|||||17.4|-12.3|0.738
74087535|NCT03346070|147729223|SUPERIORITY||Difference in percentage|11.1||||0.077|TWO_SIDED|95.0|-1.7|26.3|||Miettinen & Nurminen method|||||26.3|-1.7|0.077
74087536|NCT03346070|147729223|SUPERIORITY||Difference in percentage|2.4||||0.717|TWO_SIDED|95.0|-12.0|16.4|||Miettinen & Nurminen method|||||16.4|-12.0|0.717
74087537|NCT03346070|147729223|SUPERIORITY||Difference in percentage|5.0||||0.486|TWO_SIDED|95.0|-9.9|19.7|||Miettinen & Nurminen method|||||19.7|-9.9|0.486
74087538|NCT03346070|147729223|SUPERIORITY||Difference in percentage|-1.2||||0.849|TWO_SIDED|95.0|-16.2|12.4|||Miettinen & Nurminen method|||||12.4|-16.2|0.849
73926592|NCT01023581|147380498|SUPERIORITY_OR_OTHER||LS mean difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.96|-0.37||For each set of comparisons in the primary analysis, the null hypothesis was rejected only if both comparisons between a combination and its constituent doses were statistically significant at the 2-sided 2.5% level.|ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||The primary efficacy analysis consisted of 2 separate sets of comparisons between each BID combination of alogliptin and metformin (alogliptin/metformin 12.5/500 mg BID and 12.5/1000 mg BID) and its constituent doses of alogliptin and metformin. The null hypothesis was that the combination of alogliptin and metformin had no additional effect on glycemic control at Week 26 either when compared with the constituent dose of alogliptin or with the constituent dose of metformin.||-0.37|-0.96|<0.001
73926593|NCT01023581|147380498|SUPERIORITY_OR_OTHER||LS mean difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.87|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate||||-0.27|-0.87|<0.001
73926594|NCT01023581|147380498|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|||<|0.001|TWO_SIDED|95.0|-1.29|-0.71|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||||-0.71|-1.29|<0.001
73926595|NCT01023581|147380498|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.73|-0.16|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||||-0.16|-0.73|<0.001
73926596|NCT03760796|147380555|OTHER||Hazard Ratio (HR)|0.48||||0.018|TWO_SIDED|95.0|0.26|0.88||The a priori threshold for statistical significance was \<0.05.|Regression, Cox|Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics.||||0.88|0.26|0.018
73926597|NCT03760796|147380556|OTHER|A Markov Model of cost-effectiveness, based on 30-day readmission rates, was built to assess the Incremental Cost-Effectiveness Ratio (ICER) of adopting the Corrie Platform compared to standard of care for post AMI patients; taking into account the estimated cost of Corrie ($2,750 per patient for a 1-year use term). The reported value is a ratio of the relative cost of intervention compared to the standard of care divided by the change in the outcome, quality-adjusted life years (QALYs).|Incremental Cost-Effectiveness Ratio|-7.0|||||TWO_SIDED||||||||A negative ICER means the intervention cost is lower than the cost of standard of care, while the denominator was positive. A positive ICER means the intervention cost is greater than the cost of standard of care, while the denominator was positive.|||||
73926598|NCT03760796|147380570|OTHER||Hazard Ratio (HR)|1.45||||0.33|TWO_SIDED|95.0|0.69|2.98||The a priori threshold for statistical significance was \<0.05.|Regression, Cox|Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics.||||2.98|0.69|0.33
73926599|NCT05664490|147380575|SUPERIORITY||Risk Ratio (RR)|0.88||||0.44|TWO_SIDED|95.0|0.64|1.22||The threshold for statistical significance is 0.05.|Poisson regression|We used Poisson regression with a log-link and robust standard errors to assess the effect of our intervention on PrEP adherence at Week 12|The Standard of Care Mental Health Services arm was the reference category for the risk ratio.|||1.22|0.64|0.44
74087539|NCT03346070|147729223|SUPERIORITY||Difference in percentage|-4.9||||0.339|TWO_SIDED|95.0|-18.2|6.7|||Miettinen & Nurminen method|||||6.7|-18.2|0.339
74087540|NCT03346070|147729223|SUPERIORITY||Difference in percentage|6.6||||0.149|TWO_SIDED|95.0|-2.6|16.8|||Miettinen & Nurminen method|||||16.8|-2.6|0.149
74087541|NCT03346070|147729224|SUPERIORITY||Difference in percentage|-2.7||||0.299|TWO_SIDED|95.0|-13.9|6.7|||Miettinen & Nurminen method|||||6.7|-13.9|0.299
74087542|NCT03346070|147729224|SUPERIORITY||Difference in percentage|0.0|||>|0.999|TWO_SIDED|95.0|-9.9|9.4|||Miettinen & Nurminen method|||||9.4|-9.9|>0.999
74087543|NCT03346070|147729224|SUPERIORITY||Difference in percentage|-2.6||||0.326|TWO_SIDED|95.0|-13.7|7.0|||Miettinen & Nurminen method|||||7.0|-13.7|0.326
74087544|NCT03346070|147729224|SUPERIORITY||Difference in percentage|-2.5||||0.335|TWO_SIDED|95.0|-13.6|7.1|||Miettinen & Nurminen method|||||7.1|-13.6|0.335
74087545|NCT03346070|147729224|SUPERIORITY||Difference in percentage|0.3||||0.935|TWO_SIDED|95.0|-11.1|11.9|||Miettinen & Nurminen method|||||11.9|-11.1|0.935
74087546|NCT03346070|147729224|SUPERIORITY||Difference in percentage|-2.7||||0.326|TWO_SIDED|95.0|-13.8|7.3|||Miettinen & Nurminen method|||||7.3|-13.8|0.326
74087547|NCT03346070|147729224|SUPERIORITY||Difference in percentage|-1.4||||0.299|TWO_SIDED|95.0|-7.5|3.5|||Miettinen & Nurminen method|||||3.5|-7.5|0.299
74087548|NCT03346070|147729225|SUPERIORITY||Difference in percentage|0.1|||||TWO_SIDED|95.0|-12.7|13.1|||||Miettinen and Nurminen method|||13.1|-12.7|
74087549|NCT03346070|147729225|SUPERIORITY||Difference in percentage|-3.6|||||TWO_SIDED|95.0|-19.6|12.2|||||Miettinen and Nurminen method|||12.2|-19.6|
74087550|NCT03346070|147729225|SUPERIORITY||Difference in percentage|5.1|||||TWO_SIDED|95.0|-8.1|19.7|||||Miettinen and Nurminen method|||19.7|-8.1|
74087551|NCT03346070|147729225|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-18.0|13.1|||||Miettinen and Nurminen method|||13.1|-18.0|
74087552|NCT03346070|147729225|SUPERIORITY||Difference in percentage|4.4|||||TWO_SIDED|95.0|-9.6|19.2|||||Miettinen and Nurminen method|||19.2|-9.6|
74087553|NCT03346070|147729225|SUPERIORITY||Difference in percentage|2.2|||||TWO_SIDED|95.0|-12.5|17.0|||||Miettinen and Nurminen method|||17.0|-12.5|
74087554|NCT03346070|147729225|SUPERIORITY||Difference in percentage|-1.8|||||TWO_SIDED|95.0|-11.4|7.8|||||Miettinen and Nurminen method|||7.8|-11.4|
74087555|NCT03346070|147729226|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-15.2|9.1|||||Miettinen and Nurminen method|||9.1|-15.2|
74087556|NCT03346070|147729226|SUPERIORITY||Difference in percentage|-8.5|||||TWO_SIDED|95.0|-22.3|1.3|||||Miettinen and Nurminen method|||1.3|-22.3|
74087557|NCT03346070|147729226|SUPERIORITY||Difference in percentage|-5.3|||||TWO_SIDED|95.0|-18.8|6.8|||||Miettinen and Nurminen method|||6.8|-18.8|
74087558|NCT03346070|147729226|SUPERIORITY||Difference in percentage|-8.0|||||TWO_SIDED|95.0|-21.2|1.8|||||Miettinen and Nurminen method|||1.8|-21.2|
74087559|NCT03346070|147729226|SUPERIORITY||Difference in percentage|-2.9|||||TWO_SIDED|95.0|-17.0|10.5|||||Miettinen and Nurminen method|||10.5|-17.0|
74087560|NCT03346070|147729226|SUPERIORITY||Difference in percentage|0.5|||||TWO_SIDED|95.0|-14.0|15.5|||||Miettinen and Nurminen method|||15.5|-14.0|
74087561|NCT03346070|147729226|SUPERIORITY||Difference in percentage|-5.5|||||TWO_SIDED|95.0|-13.9|1.2|||||Miettinen and Nurminen method|||1.2|-13.9|
74087562|NCT03346070|147729227|SUPERIORITY||Difference in percentage|-2.4|||||TWO_SIDED|95.0|-13.4|7.3|||||Miettinen and Nurminen method|||7.3|-13.4|
74087563|NCT03346070|147729227|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-12.3|10.8|||||Miettinen and Nurminen method|||10.8|-12.3|
74087564|NCT03346070|147729227|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-13.7|7.0|||||Miettinen and Nurminen method|||7.0|-13.7|
74087565|NCT03346070|147729227|SUPERIORITY||Difference in percentage|0.2|||||TWO_SIDED|95.0|-11.2|11.7|||||Miettinen and Nurminen method|||11.7|-11.2|
74087566|NCT03346070|147729227|SUPERIORITY||Difference in percentage|-0.2|||||TWO_SIDED|95.0|-11.5|11.0|||||Miettinen and Nurminen method|||11.0|-11.5|
74087567|NCT03346070|147729227|SUPERIORITY||Difference in percentage|0.2|||||TWO_SIDED|95.0|-11.0|12.0|||||Miettinen and Nurminen method|||12.0|-11.0|
74087568|NCT03346070|147729228|SUPERIORITY||Difference in percentage|3.0|||||TWO_SIDED|95.0|-10.8|16.9|||||Miettinen and Nurminen method|||16.9|-10.8|
74087569|NCT03346070|147729228|SUPERIORITY||Difference in percentage|-76.1|||||TWO_SIDED|95.0|-87.2|-57.6|||||Miettinen and Nurminen method|||-57.6|-87.2|
74087570|NCT03346070|147729228|SUPERIORITY||Difference in percentage|-78.7|||||TWO_SIDED|95.0|-88.8|-61.1|||||Miettinen and Nurminen method|||-61.1|-88.8|
74087571|NCT03346070|147729228|SUPERIORITY||Difference in percentage|2.8|||||TWO_SIDED|95.0|-7.2|14.2|||||Miettinen and Nurminen method|||14.2|-7.2|
74087572|NCT03346070|147729228|SUPERIORITY||Difference in percentage|2.9|||||TWO_SIDED|95.0|-4.8|11.0|||||Miettinen and Nurminen method|||11.0|-4.8|
74087573|NCT03346070|147729229|SUPERIORITY||Ratio of geometric means|0.64|||||TWO_SIDED|95.0|0.48|0.86|||||Log transformation and t-distribution|||0.86|0.48|
74087574|NCT03346070|147729229|SUPERIORITY||Ratio of geometric means|0.09|||||TWO_SIDED|95.0|0.06|0.12|||||Log transformation and t-distribution|||0.12|0.06|
74087575|NCT03346070|147729229|SUPERIORITY||Ratio of geometric means|0.14|||||TWO_SIDED|95.0|0.1|0.19|||||Log transformation and t-distribution|||0.19|0.10|
74087576|NCT03346070|147729229|SUPERIORITY||Ratio of geometric means|0.54|||||TWO_SIDED|95.0|0.4|0.71|||||Log transformation and t-distribution|||0.71|0.40|
74087577|NCT03346070|147729229|SUPERIORITY||Ratio of geometric means|0.59|||||TWO_SIDED|95.0|0.48|0.72|||||Log transformation and t-distribution|||0.72|0.48|
74087578|NCT03346070|147729230|SUPERIORITY||Ratio of geometric means|0.63|||||TWO_SIDED|95.0|0.5|0.8|||||Log transformation and t-distribution|||0.80|0.50|
74087579|NCT03346070|147729230|SUPERIORITY||Ratio of geometric means|0.09|||||TWO_SIDED|95.0|0.07|0.13|||||Log transformation and t-distribution|||0.13|0.07|
74087580|NCT03346070|147729230|SUPERIORITY||Ratio of geometric means|0.15|||||TWO_SIDED|95.0|0.11|0.2|||||Log transformation and t-distribution|||0.20|0.11|
74087581|NCT03346070|147729230|SUPERIORITY||Ratio of geometric means|0.56|||||TWO_SIDED|95.0|0.44|0.72|||||Log transformation and t-distribution|||0.72|0.44|
74087582|NCT03346070|147729230|SUPERIORITY||Ratio of geometric means|0.6|||||TWO_SIDED|95.0|0.51|0.7|||||Log transformation and t-distribution|||0.70|0.51|
74087583|NCT03346070|147729231|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.54|0.81|||||Log transformation and t-distribution|||0.81|0.54|
74087584|NCT03346070|147729231|SUPERIORITY||Ratio of geometric means|0.13|||||TWO_SIDED|95.0|0.09|0.17|||||Log transformation and t-distribution|||0.17|0.09|
73862558|NCT00996801|147270802|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.14||||0.053|TWO_SIDED|95.0|-2.29|0.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.01|-2.29|0.053
73862559|NCT00996801|147270802|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.15||||0.053|TWO_SIDED|95.0|-2.19|-0.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.11|-2.19|0.053
73862560|NCT00996801|147270802|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.58||||0.509|TWO_SIDED|95.0|-1.77|0.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.60|-1.77|0.509
73862561|NCT00996801|147270802|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.25||||0.843|TWO_SIDED|95.0|-1.27|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.77|-1.27|0.843
73862562|NCT00996801|147270802|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.26||||0.843|TWO_SIDED|95.0|-1.43|0.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.92|-1.43|0.843
73862563|NCT00996801|147270803|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|86.33|||<|0.001|TWO_SIDED|95.0|64.87|108.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||108.29|64.87|<0.001
73862564|NCT00996801|147270803|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|82.14|||<|0.001|TWO_SIDED|95.0|63.0|101.66||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||101.66|63.00|<0.001
73926600|NCT05664490|147380576|SUPERIORITY||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.71|1.42||The threshold for statistical significance was 0.05.|Poisson regression|We used Poisson regression with a log-link and robust standard errors to assess the effect of our intervention on reduced CMD symptoms at Week 12.|The reference category for the risk ratio presented is the Standard of Care Mental Health Services arm.|||1.42|0.71|0.99
74029171|NCT01845077|147612684|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|107.7|||||TWO_SIDED|90.0|92.5|125.4|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||125.4|92.5|
74087585|NCT03346070|147729231|SUPERIORITY||Ratio of geometric means|0.19|||||TWO_SIDED|95.0|0.14|0.27|||||Log transformation and t-distribution|||0.27|0.14|
74087586|NCT03346070|147729231|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.52|0.83|||||Log transformation and t-distribution|||0.83|0.52|
73926601|NCT05664490|147380577|SUPERIORITY||Risk Ratio (RR)|1.4||||0.03|TWO_SIDED|95.0|1.03|1.89||The threshold for statistical significance was 0.05|Poisson regression|We used Poisson regression with a log-link to estimate to assess the effect of our intervention on PrEP adherence at Week 4.|The Standard of Care Mental Health Services arm was the reference category for the risk ratio.|||1.89|1.03|0.03
73926602|NCT05664490|147380578|SUPERIORITY||Risk Ratio (RR)|0.81||||0.37|TWO_SIDED|95.0|0.5|1.29||The threshold for statistical significance was 0.05|Poisson regression|We used Poisson regression with a log-link to assess the effect of the intervention on common mental disorders at Week 4.|The Standard of Care Mental Health Services arm was the reference category.|||1.29|0.50|0.37
73862565|NCT00996801|147270803|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|107.26|||<|0.001|TWO_SIDED|95.0|82.03|133.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||133.23|82.03|<0.001
73862566|NCT00996801|147270803|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.87||||0.104|TWO_SIDED|95.0|-3.8|49.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||49.68|-3.80|0.104
73862567|NCT00996801|147270803|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|18.68||||0.123|TWO_SIDED|95.0|-5.11|42.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||42.56|-5.11|0.123
73862568|NCT00996801|147270803|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|43.8||||0.003|TWO_SIDED|95.0|12.85|75.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||75.06|12.85|0.003
73862569|NCT00996801|147270804|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|187.31|||<|0.001|TWO_SIDED|95.0|154.44|221.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||221.25|154.44|<0.001
74029172|NCT03461289|147612699|SUPERIORITY||Difference of Proportion|0.71|||<|0.0001|TWO_SIDED|95.0|0.48|0.87|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 6 out of 23 (26.1%) babies were alive and did not need mechanical ventilation at 14 months of age.|0.87|0.48|<0.0001
74029173|NCT03242759|147612744|OTHER|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.505
74087587|NCT03346070|147729231|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.57|0.77|||||Log transformation and t-distribution|||0.77|0.57|
73926603|NCT01334723|147380587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||||95.0|0.35|0.412|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.412|0.350|
73926604|NCT01334723|147380587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.294||||||95.0|0.235|0.368|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.368|0.235|
73926605|NCT01334723|147380588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.613||||||95.0|0.562|0.668|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.668|0.562|
73969171|NCT03158714|147477359|SUPERIORITY||Mean Difference (Net)|0.172||||0.152|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.152
73969172|NCT01160211|147477378|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0063|TWO_SIDED|95.0|0.45|0.88||Pike estimate of the treatment hazard ratio, \<1 indicates a lower risk compared with trastuzumab + AI.|Log Rank|using a two-sided stratified log-rank test (based on stratification factors)||Null hypothesis H0: λ ≥ 1 or to reject it in favor of the alternative hypothesis HA: λ \<1, where λ is the hazard ratio (HR) between Treatment Group A and Treatment Group B for progression-free survival.||0.88|0.45|0.0063
73969173|NCT01160211|147477380|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.44|0.79||||||||0.79|0.44|
73969174|NCT01160211|147477380|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.66|1.15||||||||1.15|0.66|
73969175|NCT01160211|147477380|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.51|0.92||||||||0.92|0.51|
73969176|NCT01160211|147477386|SUPERIORITY||Least square difference|-1.79|STANDARD_ERROR_OF_MEAN|2.111|||TWO_SIDED|95.0|-5.95|2.36||||||FACT-B total score||2.36|-5.95|
73969177|NCT01160211|147477386|SUPERIORITY||Least square difference|-3.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-8.09|0.29||||||FACT-B total score||0.29|-8.09|
73969178|NCT01160211|147477386|SUPERIORITY||Least square difference|-1.5|STANDARD_ERROR_OF_MEAN|1.739|||TWO_SIDED|95.0|-4.92|1.92||||||FACT-G total score||1.92|-4.92|
73969179|NCT01160211|147477386|SUPERIORITY||Least square difference|-3.1|STANDARD_ERROR_OF_MEAN|1.751|||TWO_SIDED|95.0|-6.55|0.34||||||FACT-G total score||0.34|-6.55|
73969180|NCT01160211|147477386|SUPERIORITY||Least square difference|-2.7|STANDARD_ERROR_OF_MEAN|1.502|||TWO_SIDED|95.0|-5.66|0.25||||||FACT-B trial outcome index (TOI)||0.25|-5.66|
73969181|NCT01160211|147477386|SUPERIORITY||Least square difference|-3.61|STANDARD_ERROR_OF_MEAN|1.512|||TWO_SIDED|95.0|-6.59|-0.64||||||FACT-B trial outcome index (TOI)||-0.64|-6.59|
73926606|NCT01334723|147380588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.542||||||95.0|0.427|0.689|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.689|0.427|
73969182|NCT01160211|147477386|SUPERIORITY||Least square difference|-1.46|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.82|-0.11||||||Physical well-being (PWB)||-0.11|-2.82|
73969183|NCT01160211|147477386|SUPERIORITY||Least square difference|-1.54|STANDARD_ERROR_OF_MEAN|0.693|||TWO_SIDED|95.0|-2.9|-0.18||||||Physical well-being (PWB)||-0.18|-2.90|
73969184|NCT01160211|147477386|SUPERIORITY||Least square difference|0.39|STANDARD_ERROR_OF_MEAN|0.711|||TWO_SIDED|95.0|-1.01|1.79||||||Social family wellbeing (SWB)||1.79|-1.01|
73969185|NCT01160211|147477386|SUPERIORITY||Least square difference|-0.55|STANDARD_ERROR_OF_MEAN|0.715|||TWO_SIDED|95.0|-1.96|0.86||||||Social family wellbeing (SWB)||0.86|-1.96|
73969186|NCT01160211|147477386|SUPERIORITY||Least square difference|0.54|STANDARD_ERROR_OF_MEAN|0.568|||TWO_SIDED|95.0|-0.57|1.66||||||Emotional wellbeing (EWB)||1.66|-0.57|
73969187|NCT01160211|147477386|SUPERIORITY||Least square difference|0.4|STANDARD_ERROR_OF_MEAN|0.571|||TWO_SIDED|95.0|-0.72|1.53||||||Emotional wellbeing (EWB)||1.53|-0.72|
73926607|NCT01334723|147380589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.519||||||95.0|0.472|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.570|0.472|
73969188|NCT01160211|147477386|SUPERIORITY||Least square difference|-0.99|STANDARD_ERROR_OF_MEAN|0.646|||TWO_SIDED|95.0|-2.26|0.28||||||Functional wellbeing (FWB)||0.28|-2.26|
73969189|NCT01160211|147477386|SUPERIORITY||Least square difference|-1.32|STANDARD_ERROR_OF_MEAN|0.649|||TWO_SIDED|95.0|-2.6|-0.04||||||Functional wellbeing (FWB)||-0.04|-2.60|
73969190|NCT01160211|147477386|SUPERIORITY||Least square difference|-0.35|STANDARD_ERROR_OF_MEAN|0.665|||TWO_SIDED|95.0|-1.66|0.95||||||Breast cancer subscale (BCS)||0.95|-1.66|
73969191|NCT01160211|147477386|SUPERIORITY||Least square difference|-0.83|STANDARD_ERROR_OF_MEAN|0.668|||TWO_SIDED|95.0|-2.14|0.48||||||Breast cancer subscale (BCS)||0.48|-2.14|
73969192|NCT02561585|147477407|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.97|TWO_SIDED|95.0|-12.05|11.65||t-test in a baseline adjusted linear model|t-test, 2 sided|t-test, 2 sided on a 5% level||||11.65|-12.05|0.97
73969193|NCT03134196|147477421|SUPERIORITY||Hazard Ratio (HR)|0.78|STANDARD_DEVIATION|0.11|||TWO_SIDED|95.0|0.5|1.06||||||||1.06|0.5|
73969194|NCT03134196|147477422|SUPERIORITY||Hazard Ratio (HR)|0.74|STANDARD_DEVIATION|0.04|||TWO_SIDED|95.0|0.56|0.99||||||||0.99|0.56|
73969195|NCT00875277|147477427|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73969196|NCT00875277|147477427|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73969197|NCT00875277|147477427|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73969198|NCT00875277|147477427|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73926608|NCT01334723|147380589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.436||||||95.0|0.333|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.570|0.333|
73926609|NCT01289847|147380609|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||one-sample Poisson rate|||For the primary efficacy analysis, the SABI rate for GAMMAPLEX and the upper bound of its one-sided 99% confidence interval (CI) were estimated by using the exact method for a one-sample Poisson rate.||||0.01
73926610|NCT01289847|147380610|SUPERIORITY_OR_OTHER|||||||0.01|ONE_SIDED|99.0|||||one-sample Poisson method|||||||0.01
73969199|NCT00875277|147477427|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73969200|NCT00875277|147477427|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73969201|NCT00875277|147477427|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
73969202|NCT00875277|147477427|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||0.082
73969203|NCT00875277|147477427|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||0.009
73969204|NCT00875277|147477427|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
73969205|NCT00875277|147477427|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73969206|NCT00875277|147477427|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73926611|NCT05876273|147380615|OTHER|The statistical analysis included general linear models (GLM), with repeated measures (NAP vs UMPC) and a covariate the 1-hour average CGM level prior to initiating either controller. This covariate was used to compute the adjusted performance differences between NAP and UMPC. The data was analyzed using the GLM procedures of IBM SPSS 28.0.||||||0.2||||||1-hour average CGM level prior to initiating either controller was included as a covariate in the analysis. This covariate was used to compute the adjusted performance differences between NAP and UMPC.|GLM with Repeated Measures|General linear models (GLM), with repeated measures (NAP vs UMPC)||||||0.2
73926612|NCT03552575|147380620|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.19|TWO_SIDED|95.0|-4.8|1.0|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||1.0|-4.8|0.19
73926613|NCT03552575|147380621|SUPERIORITY||Ratio of adjusted geometric means|0.85||||0.31|TWO_SIDED|95.0|0.63|1.16|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, and use of diuretics at baseline||||1.16|0.63|0.31
73926614|NCT03552575|147380622|SUPERIORITY||Ratio of adjusted geometric means|0.87||||0.41|TWO_SIDED|95.0|0.62|1.22|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, and use of diuretics at baseline||||1.22|0.62|0.41
73926615|NCT03552575|147380623|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.1|TWO_SIDED|95.0|-6.8|0.6|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.6|-6.8|0.10
73926616|NCT03552575|147380624|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.29|TWO_SIDED|95.0|-6.6|2.0|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||2.0|-6.6|0.29
73926617|NCT03552575|147380625|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.46|TWO_SIDED|95.0|-2.0|0.9|||Regression, Linear|adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.9|-2.0|0.46
73926618|NCT03552575|147380626|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.16|TWO_SIDED|95.0|-3.5|0.6|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.6|-3.5|0.16
73926619|NCT03552575|147380627|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.56
73926620|NCT01405963|147380636|OTHER||Treatment Difference|7.65||||0.09|TWO_SIDED|95.0|-1.3|16.6|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures analysis of covariance (ANCOVA) that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||16.60|-1.30|0.09
73926621|NCT01405963|147380636|OTHER||Treatment Difference|9.91||||0.02|TWO_SIDED|95.0|1.59|18.23|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||18.23|1.59|0.02
73926622|NCT01405963|147380637|OTHER||Treatment Difference|-4.35||||0.11|TWO_SIDED|95.0|-9.8|1.1|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures analysis of covariance (ANCOVA) that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||1.10|-9.80|0.11
74087588|NCT02551679|147729243|SUPERIORITY||Cox Proportional Hazard|2.046||||0.258|TWO_SIDED|95.0|0.577|7.255|||ANCOVA|||The primary hypothesis of this study is that ACP-01 is superior to placebo in terms of the earlier time from treatment with Investigational Medicinal Product (IMP) to either de-novo gangrene, or doubling of wound size, or major amputation, or death.||7.255|0.577|0.258
73926623|NCT01405963|147380637|OTHER||Treatment Difference|-4.66||||0.07|TWO_SIDED|95.0|-9.71|0.39|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.39|-9.71|0.07
73926624|NCT01405963|147380641|OTHER||Treatment Difference|8.57||||0.05|TWO_SIDED|95.0|0.01|17.13|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||17.13|0.01|0.05
73969207|NCT00875277|147477427|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73969208|NCT00875277|147477427|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73969209|NCT00875277|147477427|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
73969210|NCT04292223|147477485|OTHER|Comparison of the 16-week value with the baseline value|Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|8.8|19.3|||Mixed Models Analysis|||||19.3|8.8|<0.0001
73926625|NCT01405963|147380641|OTHER||Treatment Difference|10.27||||0.06|TWO_SIDED|95.0|-0.46|21.0|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||21.00|-0.46|0.06
73926626|NCT01405963|147380642|OTHER||Treatment Difference|-6.08||||0.03|TWO_SIDED|95.0|-11.56|-0.6|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||-0.60|-11.56|0.03
73926627|NCT01405963|147380642|OTHER||Treatment Difference|-7.44||||0.03|TWO_SIDED|95.0|-14.22|-0.66|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||-0.66|-14.22|0.03
73926628|NCT01405963|147380643|OTHER||Treatment Difference|0.33||||0.05|TWO_SIDED|95.0|-0.01|0.68|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.68|-0.01|0.05
73926629|NCT01405963|147380643|OTHER||Treatment Difference|0.39||||0.08|TWO_SIDED|95.0|-0.06|0.84|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.84|-0.06|0.08
73926630|NCT01405963|147380644|OTHER||Treatment Difference|0.28||||0.03|TWO_SIDED|95.0|0.03|0.53|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.53|0.03|0.03
73926631|NCT01405963|147380644|OTHER||Treatment Difference|0.33||||0.06|TWO_SIDED|95.0|-0.01|0.66|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.66|-0.01|0.06
73926632|NCT01405963|147380645|OTHER||Treatment Difference|0.41||||0.01|TWO_SIDED|95.0|0.12|0.7|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.70|0.12|0.01
73926633|NCT01405963|147380645|OTHER||Treatment Difference|0.42||||0.01|TWO_SIDED|95.0|0.11|0.72|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.72|0.11|0.01
73926634|NCT01405963|147380646|OTHER||Treatment Difference|0.24||||0.02|TWO_SIDED|95.0|0.04|0.45|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.45|0.04|0.02
73969211|NCT00753545|147477491|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||<|1e-05|TWO_SIDED|95.0|0.25|0.49|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.49|0.25|<0.00001
73969212|NCT00753545|147477492|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.55|0.95|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.95|0.55|0.02
73969213|NCT00753545|147477496|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-27.1||||0.03185|TWO_SIDED|95.0|-51.9|-2.4|||ANCOVA|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||LS mean \< 0 favours olaparib||-2.4|-51.9|0.03185
73862570|NCT00996801|147270804|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|200.29|||<|0.001|TWO_SIDED|95.0|161.21|240.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||240.91|161.21|<0.001
73862571|NCT00996801|147270804|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|224.3|||<|0.001|TWO_SIDED|95.0|180.19|270.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||270.39|180.19|<0.001
73862572|NCT00996801|147270804|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|48.29||||0.034|TWO_SIDED|95.0|3.75|93.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||93.11|3.75|0.034
73862573|NCT00996801|147270804|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|61.27||||0.019|TWO_SIDED|95.0|8.8|114.22||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||114.22|8.80|0.019
73862574|NCT00996801|147270804|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|85.28||||0.002|TWO_SIDED|95.0|26.7|144.63||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||144.63|26.70|0.002
73862575|NCT00996801|147270805|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|133.03|||<|0.001|TWO_SIDED|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||156.75|110.01|<0.001
73926635|NCT01405963|147380646|OTHER||Treatment Difference|0.18||||0.15|TWO_SIDED|95.0|-0.07|0.44|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.44|-0.07|0.15
73926636|NCT00176592|147380655|SUPERIORITY|This includes p value for rank sum test treatment comparison. This includes p value for rank sum test treatment comparison of intention to treat study population.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||This includes p value for rank sum test treatment comparison. This includes p value for rank sum test treatment comparison of intention to treat study population.||||<0.05
73969214|NCT00753545|147477500|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||<|1e-05|TWO_SIDED|95.0|0.25|0.47|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.47|0.25|<0.00001
73969215|NCT00753545|147477504|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.22|TWO_SIDED|95.0|0.88|1.71|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.71|0.88|0.22
73969216|NCT00753545|147477505|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.67|TWO_SIDED|95.0|0.75|1.56|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.56|0.75|0.67
73969217|NCT00753545|147477506|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.38|TWO_SIDED|95.0|0.83|1.64|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.64|0.83|0.38
73969218|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|-0.37||||0.011|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M2-M3)||||0.011
73969219|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|-0.69||||0.008|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M3-M6)||||0.008
74029174|NCT03242759|147612744|OTHER|||||||0.181|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.181
73862576|NCT00996801|147270805|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|133.03||||0.001|TWO_SIDED|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||156.75|110.01|0.001
73862577|NCT00996801|147270805|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|131.53|||<|0.001|TWO_SIDED|95.0|110.7|152.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||152.94|110.70|<0.001
73862578|NCT00996801|147270805|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|169.8|||<|0.001|TWO_SIDED|95.0|141.59|199.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||199.11|141.59|<0.001
73862579|NCT00996801|147270805|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|58.57|||<|0.001|TWO_SIDED|95.0|29.42|88.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||88.04|29.42|<0.001
73862580|NCT00996801|147270805|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|57.07|||<|0.001|TWO_SIDED|95.0|30.76|83.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||83.64|30.76|<0.001
73926637|NCT05045144|147380722|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC Ratio|1.02|||||TWO_SIDED|95.0|0.92|1.13|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 2 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.13|0.92|
73926638|NCT05045144|147380722|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.85|1.05|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.05|0.85|
73926639|NCT05045144|147380722|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.83|1.03|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 2 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.03|0.83|
73969220|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|0.08||||0.662|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. iners at baseline and during Nuvaring Use (M2-M3)||||0.662
73969221|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|0.48||||0.41|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. iners at baseline and during Nuvaring Use (M3-M6)||||0.41
73969222|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|0.23||||0.164|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. crispatus at baseline and during Nuvaring Use (M2-M3)||||0.164
73969223|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|0.35||||0.183|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|||Mean quantity of L. crispatus at baseline and during Nuvaring Use (M3-M6)||||0.183
73969224|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|0.12||||0.506|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. jensenii at baseline and during Nuvaring Use (M2-M3)||||0.506
74087589|NCT01546142|147729251|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.983|||<|0.001|TWO_SIDED|95.0|2.311|3.849|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||3.849|2.311|<0.001
73969225|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|0.38||||0.119|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. jensenii at baseline and during Nuvaring Use (M3-M6)||||0.119
74087590|NCT01546142|147729252|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|6.271|||<|0.001|TWO_SIDED|95.0|2.908|13.52|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||13.520|2.908|<0.001
74087591|NCT01546142|147729253|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|7.838|||<|0.001|TWO_SIDED|95.0|3.299|18.622|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||18.622|3.299|<0.001
74087592|NCT01546142|147729254|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||||<0.001
74087593|NCT00440466|147729256|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment of -0.3 g/dL between QW and Q2W groups, a pooled standard deviation of 1.5 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 200 subjects (100 per group) would provide 90% power to demonstrate that Q2W group would not inferior to QW group for an overall 2-sided 0.05 significance level.|Difference of Least Squares Means|-0.03|STANDARD_ERROR_OF_MEAN|0.092|||TWO_SIDED|95.0|-0.208|0.153|||ANCOVA|||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-2-weeks (Q2W) and once-weekly (QW) groups would be lower than -1 g/dL.||0.153|-0.208|
74087594|NCT00440466|147729256|NON_INFERIORITY_OR_EQUIVALENCE|Under the same assumptions in the sample size calculation for the QW and the Q2W, 100 subjects would be needed for the Q4W. However, because Study EPO-AKD-3001 and the current study both included QW and Q2W groups, the sample size would add up to 200 for each group if combined, the sample size in the Q4W group in the current study was increased to 200 subjects in order to enroll a comparable and sufficiently large number of subjects in each of the 3 extended dosing groups across the 2 studies.|Difference of Least Squares Means|-0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|95.0|-0.249|0.063|||ANCOVA|||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-4-weeks (Q4W) and once-weekly (QW) groups would be lower than -1 g/dL.||0.063|-0.249|
74087595|NCT00440466|147729258|SUPERIORITY_OR_OTHER||Difference in percentage of participants|10.9|||||TWO_SIDED|95.0|0.1|21.7|||95% Confidence Interval|||||21.7|0.1|
74087596|NCT00440466|147729258|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-9.1|11.2|||95% of Confidence Interval|||||11.2|-9.1|
74087597|NCT00440466|147729259|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.13|||||TWO_SIDED|95.0|-0.113|0.372|||ANOVA|||||0.372|-0.113|
74087598|NCT00440466|147729259|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.11|||||TWO_SIDED|95.0|-0.098|0.32|||ANOVA|||||0.320|-0.098|
74087599|NCT00440466|147729260|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.2|||||TWO_SIDED|95.0|-2.0|18.3|||95% of Confidence Interval|||||18.3|-2.0|
74087600|NCT00440466|147729260|SUPERIORITY_OR_OTHER||Difference in percentage of participants|10.3||||||95.0|1.5|19.2|||95% of Confidence Interval|||||19.2|1.5|
74087601|NCT00440466|147729261|SUPERIORITY_OR_OTHER||Difference in percentage of participants|5.7|||||TWO_SIDED|95.0|-7.7|19.1|||95% of Confidence Interval|||||19.1|-7.7|
74087602|NCT00440466|147729261|SUPERIORITY_OR_OTHER||Difference in percentage of participants|9.1|||||TWO_SIDED|95.0|-2.5|20.6|||95% of Confidence Interval|||||20.6|-2.5|
74087603|NCT00440466|147729262|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-3.2|||||TWO_SIDED|95.0|-15.8|9.5|||95% of Confidence Interval|||||9.5|-15.8|
74087604|NCT00440466|147729262|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-3.0|||||TWO_SIDED|95.0|-13.9|8.0|||95% of Confidence Interval|||||8.0|-13.9|
74087605|NCT00440466|147729263|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.08||||||95.0|-0.367|0.208|||ANOVA|||||0.208|-0.367|
74087606|NCT00440466|147729263|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.206|0.289|||ANOVA|||||0.289|-0.206|
73926640|NCT05045144|147380723|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for the A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.72|||||TWO_SIDED|95.0|0.63|0.82|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).||0.82|0.63|
73969226|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|0.1||||0.51|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of Megasphaera at baseline and during Nuvaring Use (M2-M3)||||0.510
73969227|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|-0.3||||0.168|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of Megasphaera at baseline and during Nuvaring Use (M3-M6)||||0.168
73969228|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|0.07||||0.454|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of BVAB2 at baseline and during Nuvaring Use (M2-M3)||||0.454
73969229|NCT02432404|147477507|OTHER||Mean Difference (Final Values)|-0.1||||0.471|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of BVAB2 at baseline and during Nuvaring Use (M3-M6)||||0.471
73969230|NCT04963270|147477509|SUPERIORITY||Difference in Adjusted Mean|-1.02|STANDARD_DEVIATION|0.44||0.0196|TWO_SIDED|95.0|-1.88|-0.16|||ANCOVA and Conditional Mean Imputation|||||-0.16|-1.88|0.0196
73969231|NCT04963270|147477510|SUPERIORITY||Difference in Adjusted Mean|-1.02|STANDARD_ERROR_OF_MEAN|0.41||0.0123|TWO_SIDED|95.0|-1.82|-0.22|||ANCOVA and Conditional Mean Imputation|||||-0.22|-1.82|0.0123
73969232|NCT04963270|147477511|SUPERIORITY||Difference in Response Rate|-12.7||||0.088|TWO_SIDED|95.0|-27.3|1.9|||Cochran-Mantel-Haenszel|||Stratified Analysis||1.9|-27.3|0.088
73969233|NCT04963270|147477512|SUPERIORITY||Difference in Response Rate|-10.5||||0.137|TWO_SIDED|95.0|-24.2|3.3|||Cochran-Mantel-Haenszel|||Stratified Analysis||3.3|-24.2|0.137
73969234|NCT04963270|147477513|SUPERIORITY||Difference in Adjusted Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.6||0.0062|TWO_SIDED|95.0|-2.8|-0.46|||ANCOVA and Conditional Mean Imputation|||||-0.46|-2.80|0.0062
73969235|NCT04963270|147477514|SUPERIORITY||Difference in adjusted Mean|-1.68|STANDARD_ERROR_OF_MEAN|0.57||0.0034|TWO_SIDED|95.0|-2.8|-0.56|||ANCOVA and Conditional Mean Imputation|||||-0.56|-2.80|0.0034
73969236|NCT04963270|147477515|SUPERIORITY||Difference in Adjusted Mean|-1.51|STANDARD_ERROR_OF_MEAN|0.94||0.1094|TWO_SIDED|95.0|-3.36|0.34|||ANCOVA and Conditional Mean Imputation|||||0.34|-3.36|0.1094
73969237|NCT04963270|147477516|SUPERIORITY||Difference in Adjusted Mean|-1.39|STANDARD_ERROR_OF_MEAN|0.85||0.0999|TWO_SIDED|95.0|-3.05|0.27|||ANCOVA and Conditional Mean Imputation|||||0.27|-3.05|0.0999
73969238|NCT04963270|147477517|SUPERIORITY||Difference in Adjusted Mean|-2.2|STANDARD_ERROR_OF_MEAN|1.1||0.0456|TWO_SIDED|95.0|-4.36|-0.04|||ANCOVA and Conditional Mean Imputation|||||-0.04|-4.36|0.0456
73969239|NCT04963270|147477518|SUPERIORITY||Difference in Adjusted Mean|-2.11|STANDARD_ERROR_OF_MEAN|1.02||0.0382|TWO_SIDED|95.0|-4.1|-0.11|||ANCOVA and Conditional Mean Imputation|||||-0.11|-4.10|0.0382
73969240|NCT04963270|147477519|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-18.7||||0.013|TWO_SIDED|95.0|-33.5|-3.9|||Cochran-Mantel-Haenszel|||||-3.9|-33.5|0.013
73969241|NCT04963270|147477520|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-22.0||||0.002|TWO_SIDED|95.0|-36.2|-7.9|||Cochran-Mantel-Haenszel|||||-7.9|-36.2|0.002
73969242|NCT04963270|147477521|SUPERIORITY||Difference in Adjusted Mean|-2.99|STANDARD_ERROR_OF_MEAN|0.81||0.0002|TWO_SIDED|95.0|-4.57|-1.41|||ANCOVA and Conditional Mean Imputation|||||-1.41|-4.57|0.0002
73969243|NCT04963270|147477522|SUPERIORITY||Difference in Adjusted Mean|-3.0|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|-4.47|-1.53|||ANCOVA and Conditional Mean Imputation|||||-1.53|-4.47|<0.0001
73969244|NCT04963270|147477523|SUPERIORITY||Difference in Response Rate|-21.0||||0.004|TWO_SIDED|95.0|-35.4|-6.6|||Cochran-Mantel-Haenszel|||||-6.6|-35.4|0.004
73969245|NCT04963270|147477524|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-19.4||||0.005|TWO_SIDED|95.0|-32.8|-5.9|||Cochran-Mantel-Haenszel|||||-5.9|-32.8|0.005
73969246|NCT04963270|147477525|SUPERIORITY||Difference in Response Rate|-1.7||||0.847|TWO_SIDED|95.0|-19.4|15.9|||Cochran-Mantel-Haenszel|||||15.9|-19.4|0.847
73969247|NCT04963270|147477526|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-4.3||||0.441|TWO_SIDED|95.0|-15.4|6.7|||Cochran-Mantel-Haenszel|||||6.7|-15.4|0.441
73969248|NCT04963270|147477527|SUPERIORITY||Difference in Response Rate|8.5||||0.115|TWO_SIDED|95.0|-2.1|19.0|||Cochran-Mantel-Haenszel|||||19|-2.1|0.115
73969249|NCT04963270|147477528|SUPERIORITY|Stratified Analysis|Difference in Response Rate|8.8||||0.077|TWO_SIDED|95.0|-1.0|18.6|||Cochran-Mantel-Haenszel|||||18.6|-1|0.077
73969250|NCT04963270|147477529|SUPERIORITY||Risk Difference|-6.77||||0.1314|TWO_SIDED|95.0|-17.25|3.7|||Cochran-Mantel-Haenszel|||||3.70|-17.25|0.1314
73969251|NCT04963270|147477530|SUPERIORITY|Stratified Analysis|Risk Difference|-5.07||||0.2264|TWO_SIDED|95.0|-14.74|4.61|||Cochran-Mantel-Haenszel|||||4.61|-14.74|0.2264
73969252|NCT04963270|147477531|SUPERIORITY||Difference in Adjusted Mean|3.44|STANDARD_ERROR_OF_MEAN|1.45||0.0179|TWO_SIDED|95.0|0.59|6.29|||ANCOVA and Conditional Mean Imputation|||||6.29|0.59|0.0179
73969253|NCT04963270|147477532|SUPERIORITY|Stratified Analysis|Difference in Adjusted Mean|3.73|STANDARD_ERROR_OF_MEAN|1.37||0.0066|TWO_SIDED|95.0|1.04|6.42|||ANCOVA and Conditional Mean Imputation|||||6.42|1.04|0.0066
73926641|NCT05045144|147380723|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Washington/02/2019 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.79|1.1|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).||1.10|0.79|
73926642|NCT05045144|147380723|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Phuket/3073/2013 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.69|0.93|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).||0.93|0.69|
73926643|NCT05045144|147380724|NON_INFERIORITY|The non-inferiority of RSV MAT vaccine is demonstrated for RSV A neutralizing antibody titers, if the LL of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by RSV MAT vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.87|||||TWO_SIDED|95.0|0.78|0.97|||GMC ratio|||To demonstrate the immunological non-inferiority of the RSV MAT vaccine when co-administered with Flu D-QIV vaccine, compared to RSV MAT vaccine given alone as measured by the ratio of GMTs of RSV A neutralizing antibody titers at 30 days post administration (Day 31).||0.97|0.78|
73969254|NCT04026555|147477542|SUPERIORITY||Risk Ratio (RR)|1.43|||<|0.001|TWO_SIDED|95.0|1.16|1.78|||Regression, Poisson|||IPTW Poisson regression was used to model the number of escalations per visit with an offset of the log transformed length of stay normalized per 1000 bed days. Treatment effect is expressed in terms of adjusted incidence rate ratio (IRR) per 1000 patient bed days.||1.78|1.16|< 0.001
73969255|NCT04026555|147477543|SUPERIORITY||Risk Ratio (RR)|1.74|||<|0.001|TWO_SIDED|95.0|1.39|2.18||Correction for multiple comparisons was performed on all key outcomes within the primary and secondary hypotheses, respectively, using the false discovery rate method (FDR).|Regression, Logistic|||IPTW log-binomial regres- sion models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).||2.18|1.39|<0.001
74087607|NCT01005329|147729269|OTHER||||||||||||||||||The rate of the acute specified AEs (adverse events) from previous (and prior to ClinicalTrials.gov requirements) Radiation Therapy Oncology Group (RTOG) trial 9708 of RT + cisplatin was 44% and the hypothesis is that the addition of bevacizumab to IMRT + cisplatin will not increase this rate beyond 60%. This study was designed with a 1-sided, upper bound confidence interval to estimate this AE rate. Twenty-seven evaluable patients were required to have 95% confidence that the true grade 3+ non-hematologic treatment-related AE rate is not greater than 60%. Please note that this is a 95% ONE-SIDED confidence bound which is equivalent to the upper bound of a two-sided 90% confidence interval.|||
74087608|NCT02462486|147729308|NON_INFERIORITY|For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.|Percentage Difference|-1.2|||||TWO_SIDED|95.0|-5.0|2.4|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||2.4|-5.0|
73926644|NCT05045144|147380725|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|3.44|||||TWO_SIDED|95.0|-3.44|10.29|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).||10.29|-3.44|
73969256|NCT04026555|147477546|SUPERIORITY||Risk Ratio (RR)|0.76||||0.045|TWO_SIDED|95.0|0.58|0.99||Correction for multiple comparisons was performed on all key outcomes within the primary and secondary hypotheses, respectively, using the false discovery rate method (FDR).|Regression, Logistic|||IPTW log-binomial regression models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).||0.99|0.58|0.045
73969257|NCT04026555|147477551|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.14|TWO_SIDED|95.0|0.98|1.18|||Regression, Cox|||||1.18|0.98|0.14
73969258|NCT06321809|147477585|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses.||total scale score comparison||||0.24
73969259|NCT06321809|147477585|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.001
73969260|NCT06321809|147477585|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.03
74087609|NCT02462486|147729308|NON_INFERIORITY|For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.|Percentage Difference|-4.6|||||TWO_SIDED|95.0|-9.0|-0.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||-0.5|-9.0|
74087610|NCT02462486|147729309|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.1|-2.4|2.0|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||2.0|-2.4|
73969261|NCT06321809|147477585|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.003
73969262|NCT06321809|147477586|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||Weight comparison||||0.08
73862581|NCT00996801|147270805|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|95.34|||<|0.001|TWO_SIDED|95.0|60.4|130.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||130.91|60.40|<0.001
73862582|NCT00996801|147270806|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|53.86|||<|0.001|TWO_SIDED|95.0|39.31|68.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||68.60|39.31|<0.001
73862583|NCT00996801|147270806|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|53.81|||<|0.001|TWO_SIDED|95.0|41.37|66.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||66.38|41.37|<0.001
73862584|NCT00996801|147270806|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|55.47|||<|0.001|TWO_SIDED|95.0|41.19|69.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||69.94|41.19|<0.001
73862585|NCT00996801|147270806|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|20.53||||0.009|TWO_SIDED|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||35.03|5.96|0.009
73926645|NCT05045144|147380725|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Washington/02/2019 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|4.15|||||TWO_SIDED|95.0|-2.04|10.32|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).||10.32|-2.04|
73969263|NCT06321809|147477587|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||BMI Comparison||||0.13
73969264|NCT06321809|147477588|SUPERIORITY|||||||0.63|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||Waist Circumference Comparison||||0.63
73969265|NCT06321809|147477589|SUPERIORITY|||||||0.89|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||LDL Cholesterol Comparison||||0.89
73969266|NCT05235750|147477633|OTHER||Mean Difference (Net)|0.2||||0.83|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for RSES.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for RSES.|We analyzed short- (at 6 weeks post-baseline or T3) and longer-term differences (at 8 weeks post-baseline or T4) for the RSES, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.83
73969267|NCT05235750|147477633|OTHER||Mean Difference (Net)|-0.2||||0.91|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for RSES.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for RSES.|||||.91
73969268|NCT05235750|147477634|OTHER||Mean Difference (Net)|-2.1||||0.45|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACT-G.|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACT-G at scale, factor and item levels expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.45
74029175|NCT03242759|147612745|OTHER|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.571
74029176|NCT03242759|147612745|OTHER|||||||0.232|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.232
73862586|NCT00996801|147270806|SUPERIORITY_OR_OTHER||Difference in Least Mean Squares|20.47||||0.009|TWO_SIDED|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||35.03|5.96|0.009
73862587|NCT00996801|147270806|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.13||||0.009|TWO_SIDED|95.0|4.47|39.89||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||39.89|4.47|0.009
73862588|NCT01657760|147270833|EQUIVALENCE|80% power to detect difference p\<0.05 two tailed|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.03||0.87|TWO_SIDED|||||ANOVA, uncorrected for MC.|ANOVA|||||||0.87
73862589|NCT01694108|147270857|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann-Whitney-test comparing the decisional conflict scores of participating mothers vs. declining mothers.||||||<0.001
73862590|NCT02936284|147270903|SUPERIORITY||Mean Difference (Net)|0.196||||0.016|TWO_SIDED||||||Mixed Models Analysis|mixed effect regression model including covariates: child sex, child birth weight, breastfeeding duration, percent class attendance and covid grouping|difference between music and play group change|||||0.016
73862591|NCT02936284|147270904|SUPERIORITY||Mean Difference (Net)|29.9||||0.7|TWO_SIDED||||||Mixed Models Analysis||music group vs. play group baseline to 24 months|mixed effect regression analysis, unstructured covariance, no covariates. Reporting group x time interaction||||0.70
73926646|NCT05045144|147380725|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Phuket/3073/2013 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|4.08|||||TWO_SIDED|95.0|-2.46|10.58|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).||10.58|-2.46|
73926647|NCT00323492|147380748|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.42||||0.034||95.0|-0.86|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were applied.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.03|-0.86|0.034
73969269|NCT05235750|147477634|OTHER||Mean Difference (Net)|-3.3||||0.29|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACT-G.|||||.29
73969270|NCT05235750|147477634|OTHER||Mean Difference (Net)|0.8||||0.46|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|||||.46
73969271|NCT05235750|147477634|OTHER||Mean Difference (Net)|0.2||||0.79|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|||||.79
73926648|NCT00323492|147380749|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.36||||0.031||95.0|-0.67|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum text|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.03|-0.67|0.031
73926649|NCT00323492|147380750|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.1||||0.009||95.0|-0.18|-0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.02|-0.18|0.009
73926650|NCT00323492|147380751|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.64|||<|0.001||95.0|-1.01|-0.27||No adjustments for multiple comparisons were made.|Wicoxon Rank Sum test|no adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.27|-1.01|< 0.001
73926651|NCT00323492|147380752|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.1||||0.51||95.0|-0.44|0.19||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||0.19|-0.44|0.51
73926652|NCT00323492|147380753|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.79||95.0|-0.03|0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||0.02|-0.03|0.79
73926653|NCT00323492|147380754|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.86
73969272|NCT05235750|147477634|OTHER||Mean Difference (Net)|-2.1||||0.05|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|||||.05
74029177|NCT03242759|147612746|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
74029178|NCT03242759|147612746|OTHER|||||||0.375|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.375
74029179|NCT03242759|147612747|OTHER|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.027
74029180|NCT03242759|147612747|OTHER|||||||0.938|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.938
74029181|NCT03242759|147612748|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.001
74029182|NCT03242759|147612748|OTHER|||||||0.048|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.048
73926654|NCT00323492|147380756|SUPERIORITY_OR_OTHER|||||||0.65||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.65
73926655|NCT00323492|147380757|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.||||0.11
73969273|NCT05235750|147477634|OTHER||Mean Difference (Net)|-2.4||||0.03|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|||||.03
73969274|NCT05235750|147477634|OTHER||Mean Difference (Net)|-0.2||||0.82|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|||||.82
73969275|NCT05235750|147477634|OTHER||Mean Difference (Net)|-0.5||||0.58|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|||||.58
73969276|NCT05235750|147477634|OTHER||Mean Difference (Net)|-0.8||||0.56|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|||||.56
73969277|NCT05235750|147477634|OTHER||Mean Difference (Net)|-0.7||||0.58|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|||||.58
73969278|NCT05235750|147477634|OTHER||Mean Difference (Net)|-0.2||||0.58|TWO_SIDED|||||"The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|||||.58
73969279|NCT05235750|147477634|OTHER||Mean Difference (Net)|-0.3||||0.34|TWO_SIDED|||||"The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\] for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|||||.34
73969280|NCT05235750|147477634|OTHER||Mean Difference (Net)|0.4||||0.27|TWO_SIDED|||||"The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|||||.27
73969281|NCT05235750|147477634|OTHER||Mean Difference (Net)|0.0||||0.62|TWO_SIDED|||||"The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|||||.62
73862592|NCT02936284|147270905|SUPERIORITY||Mean Difference (Net)|0.073||||0.54|TWO_SIDED||||||Mixed Models Analysis||increase in weight for length z-score for music group|mixed-effect regression analysis with covariates: child sex, birth weight, breastfeeding duration, percent class attendance and covid categories||||0.540
73926656|NCT00323492|147380757|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.||||0.34
73926657|NCT00323492|147380758|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments were made.|Fisher Exact|No adjustments were made.||Null Hypothesis: treatment is not associated with the observed virologic response. Alternative Hypothesis: treatment is associated with the observed virologic response||||1.00
73969282|NCT05235750|147477635|OTHER||Mean Difference (Net)|-0.6||||0.76|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACIT-Sp-12 at scale and factor levels, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.76
74029183|NCT03242759|147612749|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.018
73926658|NCT01466387|147380761|NON_INFERIORITY_OR_EQUIVALENCE|GMC TF+YF+MenACWY-CRM/GMC TF+YF.|Ratio of GMC|1.14|||||TWO_SIDED|95.0|0.81|1.6||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two-sided 95% confidence interval around the observed ratio of geometric mean concentrations between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.||1.6|0.81|
73926659|NCT01466387|147380762|NON_INFERIORITY_OR_EQUIVALENCE|GMT TF+YF+MenACWY/GMT TF+YF.|Ratio of GMT.|0.96|||||TWO_SIDED|95.0|0.65|1.41||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.||1.41|0.65|
73926660|NCT01466387|147380763|NON_INFERIORITY_OR_EQUIVALENCE|GMT JE + Rab + MenACWY-CRM/GMT JE + Rab.|Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.7|1.16||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and centers as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between the second dose of Japanese Encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese Encephalitis and rabies virus vaccines given alone was greater than 0.5.||1.16|0.7|
73926661|NCT01466387|147380764|NON_INFERIORITY_OR_EQUIVALENCE|GMC JE + Rab + MenACWY-CRM/GMC JE + Rab.|Ratio of GMC|0.91|||||TWO_SIDED|95.0|0.71|1.17||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean concentrations between the second dose of Japanese encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese encephalitis and rabies virus vaccines given alone was greater than 0.5.||1.17|0.71|
73926662|NCT02968979|147380797|OTHER|||||||0.0032|||||||likelihood-ratio test|||Statistical analysis applies to all rows and columns.||||0.0032
73926663|NCT02968979|147380797|OTHER|||||||0.0008|||||||Chi-squared|||"Statistical Analysis 2 for Frequency of the Different Stages of Cachexia, excluding the refractory cachexia stage, in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.~Statistical analysis applies to all rows and columns."||||0.0008
73862593|NCT03921554|147270915|SUPERIORITY||Estimated change (52 weeks - baseline)|0.9|||<|0.0005|TWO_SIDED|95.0|0.5|1.2||The a priori threshold for statistical significance was \< 0.05.|Wald test||We fit a GEE model with AGS score as outcome and an indicator variable for 52 weeks. An exchangeable correlation structure was used to model intra-participant association of AGS scores. The model allowed for up to 2 measurements per participant.|"We are testing the null hypothesis is that the change from baseline (52 weeks - baseline) in AGS is zero.~45 participants had 2 measurements (at baseline and 52 weeks); 6 participants had 1 measurement (at baseline). All participants were included in the analysis."||1.2|0.5|<0.0005
73926664|NCT02968979|147380807|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
73926665|NCT02968979|147380807|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
73926666|NCT02968979|147380807|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
73926667|NCT02968979|147380807|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
73926668|NCT02968979|147380807|OTHER|||||||0.1085|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||0.1085
73926669|NCT02968979|147380807|OTHER|||||||0.0482||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||0.0482
73926670|NCT02968979|147380807|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
73926671|NCT02968979|147380807|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
73926672|NCT02968979|147380807|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
73926673|NCT02968979|147380807|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
73926674|NCT00896337|147380818|SUPERIORITY_OR_OTHER||9-month major adverse event rate|3.4|||<|0.0001|TWO_SIDED|95.0|0.9|8.5||A one-sided exact-test was used to test the hypothesis that the primary endpoint rate in the Epic-treated cohort is less than the predefined performance goal of 17.0%.|One-sided exact-test|||MAE rate was compared to a predefined performance goal of 17.0%, based on literature-derived expected rate of 8.0% for iliac stenting plus a 9.0% margin. Study had 87% statistical power to show the MAE rate (accounting for 9-month attrition of \<=15%) is less than the performance goal, assuming a 9-month MAE rate of 8.0%. If the exact one-sided 95% upper confidence bound of the observed rate is lower than the performance goal, the Epic stent would be considered to have acceptable performance.||8.5|0.9|<0.0001
74029184|NCT03242759|147612749|OTHER|||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.125
74029185|NCT03242759|147612750|OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.073
74029186|NCT03242759|147612750|OTHER|||||||0.755|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.755
74029187|NCT03242759|147612751|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
74029188|NCT03242759|147612751|OTHER|||||||0.281|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.281
74029189|NCT03242759|147612752|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
73926675|NCT02678676|147380892|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.3444|TWO_SIDED|95.0|0.88|1.04||No adjustment to the p-value|Regression, Cox|||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.||1.04|0.88|0.3444
74029190|NCT03242759|147612752|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.008
74087611|NCT02462486|147729309|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.1|-3.8|0.6|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||0.6|-3.8|
74087612|NCT02462486|147729310|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.1|-7.1|14.0|||||MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||14.0|-7.1|
73862594|NCT03921554|147270916|SUPERIORITY||Estimated change (Day 673 - Day 0)|1.09|||<|0.0005|TWO_SIDED|95.0|0.57|1.62||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model of AGS on day of treatment (modeled with cubic splines with knots at days 0, 84, 168, 336, 506, 673, and 1006). Goodness of fit criteria were used to select GEE model with AR(1) correlation structure.|We estimate change from Day 0 to Day 673 of treatment (Day 673 minus Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||1.62|0.57|<0.0005
73926676|NCT02678676|147380893|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.||1.16|0.83|
73926677|NCT01538862|147380905|SUPERIORITY|||||||0.82|||||||Regression, Linear|||||||0.82
73926678|NCT01400516|147380908|SUPERIORITY||Median Difference (Final Values)|9.5||||0.28|TWO_SIDED|||||A p-value \< 0.05 is considered statistically significant.|Linear mixed model||control-teriparatide|||||0.28
73926679|NCT01412866|147380911|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|df=1||||||0.08
73926680|NCT00082433|147380951|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.0005||95.0|0.69|0.9|||Log Rank|||The analysis was conducted when 903 progressions or deaths (446 in combination:457 in capecitabine) were observed in 960 participants.||.90|.69|.0005
73926681|NCT00082433|147380952|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.89|||<|0.0001||95.0|1.44|2.5|||Cochran-Mantel-Haenszel|||||2.50|1.44|<.0001
73926682|NCT00082433|147380956|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.||||<0.0001
74087613|NCT02462486|147729310|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.1|-4.7|16.5|||||MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||16.5|-4.7|
73926683|NCT00082433|147380957|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.1162||95.0|0.78|1.03||The test was stratified by (taxane resistance \[yes/no\], measurable disease versus non-measurable disease, prior chemotherapy for metastatic disease \[yes/no\], and anthracycline resistance \[yes/no\]).|Log Rank|The analysis was conducted at the 0.05 level and no adjustments were performed||This primary analysis was a comparison between the 2 treatment arms using a 2-sided, α=0.05 level log-rank test (to reject the null hypothesis of equality of survival). The analysis was conducted when 880 deaths (430 in combination:450 in capecitabine) were observed from the 1221 randomized participants.||1.03|.78|.1162
74087614|NCT02462486|147729311|SUPERIORITY||Percentage Difference|1.4|||||TWO_SIDED|95.0|-5.5|8.4|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||8.4|-5.5|
74087615|NCT02462486|147729311|SUPERIORITY||Percentage Difference|-2.3|||||TWO_SIDED|95.0|-9.1|4.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||4.5|-9.1|
74087616|NCT02462486|147729312|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.1|-3.5|0.3|||||MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.|||0.3|-3.5|
73926684|NCT00082433|147380957|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.0231||95.0|0.75|0.98|||Regression, Cox|||This prespecified secondary analysis was a Cox model adjusted for age, Karnofsky performance status, number of organ sites, estrogen receptor status, hepatic impairment, time from diagnosis, liver/lung metastases.||.98|.75|.0231
74029191|NCT03242759|147612753|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
74029192|NCT03242759|147612753|OTHER|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.031
74029193|NCT03242759|147612755|OTHER||||||<|0.001|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
74029194|NCT03242759|147612755|OTHER|||||||0.939|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.939
74029195|NCT03242759|147612756|OTHER|||||||0.169|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.169
74029196|NCT03242759|147612756|OTHER|||||||0.545|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.545
74029197|NCT03242759|147612757|OTHER|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.333
73926685|NCT01796197|147380960|SUPERIORITY||Pathelogic Complete Response Rate|40.0|||||TWO_SIDED||||||Two stage design, exact method||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 15% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 40% then the regimen is worthy of further study.|Null Hypothesis: pCR rate is less than or equal to 15% Alternative Hypothesis: pCR rate is greater than or equal to 40% Hypothesized False Positive Rate (alpha) : 3.9% Hypothesized False Negative Rate (1-beta) : 9.9%||||
73926686|NCT03314584|147381045|SUPERIORITY||||||<|0|||||||Mixed Models Analysis|F=21.662, df = 1||||||<0.000
73926687|NCT03314584|147381046|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|F=5.624, df=1||||||0.004
73926688|NCT03314584|147381047|SUPERIORITY|||||||0.046|||||||Mixed Models Analysis|F=3.092, df=1||||||0.046
73926689|NCT03314584|147381048|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|F=4.022, df=1||||||0.018
73926690|NCT03314584|147381049|SUPERIORITY|||||||0.598|||||||Mixed Models Analysis|F=0.279, df=1||||||0.598
73926691|NCT03314584|147381050|SUPERIORITY|||||||0.296|||||||Mixed Models Analysis|F=1.101, df=1||||||0.296
73969283|NCT05235750|147477635|OTHER||Mean Difference (Net)|-2.1||||0.19|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|||||.19
73969284|NCT05235750|147477635|OTHER||Mean Difference (Net)|-1.0||||0.35|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|||||.35
73926692|NCT03314584|147381051|SUPERIORITY|||||||0.033|||||||Mixed Models Analysis|F=4.672, df = 1||||||0.033
74029198|NCT03242759|147612757|OTHER|||||||0.786|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.786
73926693|NCT03314584|147381052|SUPERIORITY|||||||0.606|||||||Mixed Models Analysis|F=0.268, df=1||||||0.606
73926694|NCT03314584|147381053|SUPERIORITY|||||||0.287|||||||Mixed Models Analysis|F=1.142, df=1||||||0.287
73926695|NCT03314584|147381054|SUPERIORITY|||||||0.049|||||||Mixed Models Analysis|F=4.039, df=1||||||0.049
73926696|NCT03314584|147381055|SUPERIORITY|||||||0.338|||||||Mixed Models Analysis|F=1.084, df=1||||||0.338
73926697|NCT04302389|147381077|OTHER||||||<|0.001|||||||t-test, 2 sided|||This was a within-subject comparison at two timepoints (baseline, 3 months)||||<0.001
74029199|NCT03242759|147612758|OTHER|||||||0.245|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.245
74029200|NCT03242759|147612758|OTHER|||||||0.454|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.454
74029201|NCT03242759|147612759|OTHER|||||||0.543|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.543
74029202|NCT03242759|147612759|OTHER|||||||0.733|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.733
74029203|NCT03242759|147612760|OTHER|||||||0.046|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.046
74029204|NCT03242759|147612760|OTHER|||||||0.898|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.898
73926698|NCT04214288|147381098|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0167||90.0|0.42|0.82|||Log Rank|The analysis was performed using a stratified Cox Proportional Hazards model.|A hazard ratio \< 1 favours AZD9833 to be associated with a longer progression-free survival than fulvestrant.|||0.82|0.42|0.0167
73926699|NCT04214288|147381098|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.009||90.0|0.46|0.89|||Log Rank|The analysis was performed using a stratified Cox Proportional Hazards model.|A hazard ratio \< 1 favours AZD9833 to be associated with a longer progression-free survival than fulvestrant.|||0.89|0.46|0.0090
73926700|NCT04214288|147381099|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4828||90.0|0.63|3.31|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||3.31|0.63|0.4828
73926701|NCT04214288|147381099|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3691||90.0|0.69|3.67|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||3.67|0.69|0.3691
73926702|NCT04214288|147381103|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2554|TWO_SIDED|90.0|0.84|2.64|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||2.64|0.84|0.2554
73926703|NCT04214288|147381103|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1658||90.0|0.91|2.89|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||2.89|0.91|0.1658
73926704|NCT02121483|147381123|SUPERIORITY_OR_OTHER||Slope|0.949|STANDARD_ERROR_OF_MEAN|0.1075|||TWO_SIDED|95.0|0.7276|1.1704|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-inf. Based on the estimate for the slope parameter β, a 2-sided 95% confidence interval (CI) for the slope was computed.|||1.1704|0.7276|
73926705|NCT02121483|147381124|SUPERIORITY_OR_OTHER||Slope|0.9597|STANDARD_ERROR_OF_MEAN|0.1088|||TWO_SIDED|95.0|0.7356|1.1838|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-tz. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.|||1.1838|0.7356|
73926706|NCT02121483|147381125|SUPERIORITY_OR_OTHER||Slope|0.8554|STANDARD_ERROR_OF_MEAN|0.1481|||TWO_SIDED|95.0|0.5504|1.1603|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and Cmax. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.|||1.1603|0.5504|
73926707|NCT01420289|147381131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|15.0||0.086|TWO_SIDED|95.0|10.0|80.0|||t-test, 2 sided|||||80|10|0.086
74029205|NCT02522481|147612769|SUPERIORITY|||||||0.0896|||||||McNemar|||Sensitivity: superiority test comparing CE-DSE and UE-DSE based on the difference||||0.0896
73926708|NCT01420289|147381132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.05|TWO_SIDED|95.0|10.0|100.0|||t-test, 2 sided|||||100|10|<0.05
73926709|NCT01928862|147381135|OTHER||Treatment difference|-31.3|||||TWO_SIDED|90.0|-58.8|0.8||||||Confidence interval (CI) of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||0.8|-58.8|
73926710|NCT01928862|147381135|OTHER||Treatment Difference|6.3|||||TWO_SIDED|90.0|-25.3|36.9||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||36.9|-25.3|
73926711|NCT01928862|147381135|OTHER||Treatment Difference|-4.5|||||TWO_SIDED|90.0|-33.5|26.3||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||26.3|-33.5|
73926712|NCT04649164|147381141|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||Paired t-tests comparing peer mentors' baseline and 16-week scores, and caregiver mentees' baseline and 16-week scores, respectively||||0.36
73926713|NCT04649164|147381143|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.30
73926714|NCT04649164|147381144|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
73926715|NCT04649164|147381145|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
73969285|NCT05235750|147477635|OTHER||Mean Difference (Net)|-1.9||||0.99|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|||||.99
73969286|NCT05235750|147477635|OTHER||Mean Difference (Net)|0.4||||0.46|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|||||.46
73926716|NCT04649164|147381148|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
73926717|NCT02053753|147381160|NON_INFERIORITY_OR_EQUIVALENCE|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometrc Means (CP4:CP2)|1.084|||||TWO_SIDED|90.0|0.995|1.181|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.|||1.181|0.995|
73926718|NCT02053753|147381161|NON_INFERIORITY_OR_EQUIVALENCE|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometric Means (CP4:CP2)|1.028|||||TWO_SIDED|90.0|0.934|1.131|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.|||1.131|0.934|
73926719|NCT04064294|147381176|SUPERIORITY|||||||0.63||||||the threshold for statistical significance was p = 0.05|ANOVA|degrees of freedom = 78||||||0.63
73926720|NCT04064294|147381177|SUPERIORITY|||||||0.09||||||the threshold for statistical significance was p = 0.05|ANOVA|degrees of freedom = 78||||||0.09
73926721|NCT04064294|147381178|SUPERIORITY|||||||0.011|||||||Chi-squared|threshold for significance is 0.05, degrees of freedom = 2||||||0.011
73969287|NCT05235750|147477635|OTHER||Mean Difference (Net)|-0.7||||0.24|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|||||.24
74029206|NCT02522481|147612769|SUPERIORITY||||||<|0.0001|||||||McNemar|||Specificity: superiority test comparing CE-DSE and UE-DSE based on the difference||||<0.0001
73926722|NCT04064294|147381179|SUPERIORITY|||||||0.033|||||||ANOVA|degrees of freedom = 75||||||0.033
73926723|NCT03450707|147381180|OTHER||Mean Difference (Final Values)|0.34||||0.72|TWO_SIDED|95.0|-1.82|2.5||"Mixed model controlling for repeated measures within patients used to get a mean difference in lactate between the thiamine and placebo groups at 24 hours.~Lactate imputed using a penalty (20pc increase) for patients who expired."|Mixed Models Analysis|P-value is for the comparison at 24 hours from the mixed model (i.e, not a global p-value)||||2.50|-1.82|0.72
73926724|NCT03450707|147381181|OTHER||Mean Difference (Final Values)|-0.38||||0.43|TWO_SIDED|95.0|-1.34|0.58|||Regression, Linear|||As AUC-VO2s turned out to be normally distributed, we used a linear regression model to compare mean AUC-VO2s between treatment groups controlling for average temperature.||0.58|-1.34|0.43
73926725|NCT03450707|147381182|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test, testing the null hypothesis that there is no difference in the distribution of 72-hour lactates between thiamine and placebo groups.|No parameter estimated other than p-value = 0.88 from Wilcoxon rank-sum test.|||0.88
73926726|NCT03450707|147381183|OTHER||Mean Difference (Final Values)|0.4||||0.072|TWO_SIDED|95.0|0.01|0.8||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH specific activity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||0.80|0.01|0.072
73926727|NCT03450707|147381184|OTHER||Mean Difference (Final Values)|2.4||||0.044|TWO_SIDED|95.0|0.1|4.7||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH activity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||4.7|0.1|0.044
73926728|NCT03450707|147381185|OTHER||Mean Difference (Final Values)|-48.5||||0.828|TWO_SIDED|95.0|-297.0|200.0||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH quantity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||200.0|-297.0|0.828
73926729|NCT03450707|147381188|OTHER||Mean Difference (Final Values)|2.34||||0.1|TWO_SIDED|95.0|0.47|4.22||Mixed model controlling for repeated measures within patients used to get a mean difference in SOFA scores between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model.||||4.22|0.47|0.10
73969288|NCT05235750|147477635|OTHER||Mean Difference (Net)|-0.4||||0.55|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|||||.55
73969289|NCT05235750|147477635|OTHER||Mean Difference (Net)|-0.9||||0.8|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|||||.80
73969290|NCT05235750|147477635|OTHER||Mean Difference (Net)|-1.5||||0.34|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|||||.34
73969291|NCT05235750|147477635|OTHER||Mean Difference (Net)|-3.0||||0.91|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|||||.91
73969292|NCT05235750|147477636|OTHER||Mean Difference (Net)|1.1||||0.14|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for two subscales HADS-A and HADS-D respectively, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.14
73969293|NCT05235750|147477636|OTHER||Mean Difference (Net)|1.2||||0.14|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|||||.14
73969294|NCT05235750|147477636|OTHER||Median Difference (Net)|0.6||||0.32|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|||||.32
73969295|NCT05235750|147477636|OTHER||Mean Difference (Net)|0.9||||0.2|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|||||.20
73969296|NCT02301910|147477642|NON_INFERIORITY|The calculation was carried out taking into account the power of 80%||||||0.87|||||||ANOVA|||||||0.87
73969297|NCT03115476|147477650|OTHER||Hazard Ratio (HR)|1.43||||0.43|TWO_SIDED|95.0|0.61|3.9|||likelihood ratio test|||Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio||3.9|0.61|0.43
73969298|NCT03115476|147477651|OTHER||Hazard Ratio (HR)|1.99|||<|0.01|TWO_SIDED|95.0|1.17|3.62|||likelihood ratio test|||relative difference between treatment groups (ingenol disoxate gel vs vehicle) expressed as hazard ratio||3.62|1.17|<0.01
73969299|NCT03976362|147477666|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.004|TWO_SIDED|95.0|0.63|0.93||One-sided p-value based on log-rank test stratified by Eastern Cooperative Cancer Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||0.93|0.63|0.0040
74029207|NCT04003155|147612895|SUPERIORITY||LSMean Difference|-1.87|STANDARD_ERROR_OF_MEAN|0.42|<|0.001||95.0|-2.69|-1.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Least squares Mean (LSM), Standard error (SE), Confidence interval (CI), Mixed model repeated measures (MMRM), Change from Baseline (CFB), Dependent variable (dv), Treatment (tr), Week (wk), Baseline (bl), Weight (wt)||-1.05|-2.69|<0.001
74087617|NCT02462486|147729312|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.1|-3.9|-0.1|||||MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.|||-0.1|-3.9|
73969300|NCT03976362|147477667|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5481|TWO_SIDED|95.0|0.83|1.24||One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.24|0.83|0.5481
74029208|NCT04003155|147612895|SUPERIORITY||LSMean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.42|<|0.001||95.0|-2.89|-1.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.25|-2.89|<0.001
73926730|NCT03450707|147381190|OTHER||Mean Difference (Final Values)|-1.0||||0.43|TWO_SIDED|95.0|-3.6|1.6||Mixed model controlling for repeated measures within patients used to get a mean difference in Basal Respiration between the thiamine and placebo groups at 24 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.|Mean difference uses a non-logged version of the variable.|||1.6|-3.6|0.43
73926731|NCT03450707|147381191|OTHER||Mean Difference (Final Values)|0.76||||0.02|TWO_SIDED|95.0|-0.27|1.78||Mixed model controlling for repeated measures within patients used to get a mean difference in creatinine between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||1.78|-0.27|0.02
73926732|NCT00481195|147381193|SUPERIORITY_OR_OTHER|||||||0.0439||95.0|||||ANOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an analysis of variance (ANOVA) with treatment ands concurrent treatment for bipolar disorders as factors. A significant treatment-by baseline interaction was observed in the total score that violates the assumption of parallelism on which an ANCOVA is based, so the data was analyzed using ANOVA without baseline as a covariate rather than ANCOVA.||||0.0439
73926733|NCT00481195|147381194|SUPERIORITY_OR_OTHER|||||||0.0795||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0795
73926734|NCT00481195|147381195|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0272
73926735|NCT00481195|147381196|SUPERIORITY_OR_OTHER|||||||0.0802||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0802
73926736|NCT00481195|147381197|SUPERIORITY_OR_OTHER|||||||0.2407||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2407
73926737|NCT00481195|147381198|SUPERIORITY_OR_OTHER|||||||0.0502||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0502
73969301|NCT03976362|147477670|OTHER||Difference in LS Means|0.37||||0.8238|TWO_SIDED|95.0|-2.91|3.66||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||3.66|-2.91|0.8238
73969302|NCT03976362|147477671|OTHER||Hazard Ratio (HR)|0.87||||0.3083|TWO_SIDED|95.0|0.66|1.14||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.|||1.14|0.66|0.3083
73969303|NCT03976362|147477672|OTHER||Difference in Least Square Means|1.68||||0.4686|TWO_SIDED|95.0|-2.87|6.23||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||6.23|-2.87|0.4686
73926738|NCT00481195|147381199|SUPERIORITY_OR_OTHER|||||||0.0612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0612
73926739|NCT00481195|147381200|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.1980
73926740|NCT00481195|147381201|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.8960
73926741|NCT00481195|147381202|SUPERIORITY_OR_OTHER|||||||0.2575||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.2575
73926742|NCT00481195|147381203|SUPERIORITY_OR_OTHER|||||||0.3129||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.3129
74029209|NCT04003155|147612895|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
73926743|NCT00481195|147381204|SUPERIORITY_OR_OTHER|||||||0.1565||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1565
73926744|NCT00481195|147381205|SUPERIORITY_OR_OTHER|||||||0.6737||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.6737
73926745|NCT00481195|147381206|SUPERIORITY_OR_OTHER|||||||0.2249||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2249
74029210|NCT04003155|147612895|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
73926746|NCT00481195|147381207|SUPERIORITY_OR_OTHER|||||||0.0862||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0862
73926747|NCT00481195|147381208|SUPERIORITY_OR_OTHER|||||||0.9281||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.9281
73926748|NCT00481195|147381209|SUPERIORITY_OR_OTHER|||||||0.4428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.4428
73926749|NCT00481195|147381210|SUPERIORITY_OR_OTHER|||||||0.0965||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0965
73969304|NCT03976362|147477673|OTHER||Hazard Ratio (HR)|1.01||||0.9174|TWO_SIDED|95.0|0.76|1.35||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.35|0.76|0.9174
73969305|NCT03976362|147477674|OTHER||Difference in Least Square Means|3.83||||0.0245|TWO_SIDED|95.0|0.5|7.16||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||7.16|0.50|0.0245
73969306|NCT03976362|147477675|OTHER||Hazard Ratio (HR)|1.24||||0.2133|TWO_SIDED|95.0|0.88|1.75||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.75|0.88|0.2133
73969307|NCT03976362|147477676|OTHER||Hazard Ratio (HR)|0.18||||0.9381|TWO_SIDED|95.0|-4.27|4.62||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||4.62|-4.27|0.9381
73969308|NCT03976362|147477677|OTHER||Hazard Ratio (HR)|0.97||||0.8464|TWO_SIDED|95.0|0.72|1.31||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.31|0.72|0.8464
73969309|NCT03976362|147477678|OTHER||Difference in Least Square Means|-2.81||||0.087|TWO_SIDED|95.0|-6.02|0.41||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||0.41|-6.02|0.0870
73969310|NCT03976362|147477679|OTHER||Hazard Ratio (HR)|1.6||||0.002|TWO_SIDED|95.0|1.18|2.16||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||2.16|1.18|0.0020
73969311|NCT00613106|147477680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4228||95.0|||||Cochran-Mantel-Haenszel|||||||0.4228
73969312|NCT02876588|147477768|SUPERIORITY||Odds Ratio (OR)|1.03||||0.6|TWO_SIDED|95.0|0.9|1.2||Random-effects logistic regression models were constructed, using RAR order sessions as the outcome, randomization group as the independent variable, and the clinician as the random intercept to account for nesting of order sessions within clinicians|Regression, Logistic|||||1.20|.90|.60
73969313|NCT02876588|147477769|SUPERIORITY||Odds Ratio (OR)|1.03||||0.68|TWO_SIDED|95.0|0.89|1.19||Random-effects logistic regression models were constructed, using RAR order sessions as the outcome, randomization group as the independent variable, the clinician as the random intercept to account for nesting of order sessions within clinicians|Regression, Logistic|||||1.19|.89|.68
73969314|NCT02876588|147477770|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73926750|NCT00481195|147381211|SUPERIORITY_OR_OTHER|||||||0.5389||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.5389
73926751|NCT00481195|147381212|SUPERIORITY_OR_OTHER|||||||0.0793||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0793
73926752|NCT00481195|147381213|SUPERIORITY_OR_OTHER|||||||0.3814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3814
73926753|NCT00481195|147381214|SUPERIORITY_OR_OTHER|||||||0.8099||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.8099
73969315|NCT05590403|147477836|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is less than (\<) 1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||1.09|0.83|
73969316|NCT05590403|147477837|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-2.65|||||TWO_SIDED|95.0|-8.54|3.28|||||The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||3.28|-8.54|
73969317|NCT05590403|147477838|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.79|1.02|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||1.02|0.79|
73969318|NCT05590403|147477839|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-3.95|||||TWO_SIDED|95.0|-10.39|2.53|||||The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||2.53|-10.39|
73969319|NCT05590403|147477840|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.96|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||0.96|0.73|
74029211|NCT04003155|147612896|SUPERIORITY||LSMean difference|-2.39|STANDARD_ERROR_OF_MEAN|0.44|<|0.001||95.0|-3.25|-1.52||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.52|-3.25|<0.001
74029212|NCT04003155|147612896|SUPERIORITY||LSMean Difference|-2.55|STANDARD_ERROR_OF_MEAN|0.43|<|0.001||95.0|-3.4|-1.7||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.70|-3.40|<0.001
74029213|NCT04003155|147612896|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
74029214|NCT04003155|147612896|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
74029215|NCT04003155|147612897|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.012||95.0|-0.27|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.03|-0.27|0.012
74029216|NCT04003155|147612897|SUPERIORITY||LSMean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.002||95.0|-0.3|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.07|-0.30|0.002
74087618|NCT00508027|147729333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_DEVIATION|1.7|<|0.05|||||||t-test, 2 sided|||Ho: There is no change in plasma biomarker levels before and after simivastatin treatment. With 12 patients in each group and assuming a 5% risk of Type I error (two-tailed α = 0.05) and estimated SD for the change in NOx (or sVCAM-1) of 48%, power will be 80% to detect a 40% change from baseline for each group, and a 55% difference in the change in biomarker levels between dose groups. Matched paired t-tests were used to measure changes in biomarker levels from baseline.||||<0.05
74087619|NCT02740179|147729359|SUPERIORITY|||||||0.72||||||P value for Change in Coronary Flow Reserve on Cardiac PET|t-test, 2 sided|||||||0.72
73926754|NCT00481195|147381215|SUPERIORITY_OR_OTHER|||||||0.0968||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0968
73926755|NCT00481195|147381216|SUPERIORITY_OR_OTHER|||||||0.1605||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1605
74087620|NCT02740179|147729360|SUPERIORITY|||||||0.03||||||P value for Change in Stress Myocardial Blood Flow on Cardiac MRI|t-test, 2 sided|||||||0.03
74087621|NCT02740179|147729361|SUPERIORITY|||||||0.38|||||||Kruskal-Wallis|||||||0.38
74029217|NCT04003155|147612897|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
74087622|NCT02740179|147729362|SUPERIORITY|||||||0.09|||||||Kruskal-Wallis|||||||0.09
74087623|NCT02740179|147729363|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Analyses performed on log transformation of data||||||0.03
74087624|NCT02740179|147729364|SUPERIORITY|||||||0.09||||||P value for Change in Plasma IL-6|t-test, 2 sided|Analyses performed after log transformation of data||||||0.09
73926756|NCT00481195|147381217|SUPERIORITY_OR_OTHER|||||||0.1869||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1869
73926757|NCT00481195|147381218|SUPERIORITY_OR_OTHER|||||||0.0817||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0817
73926758|NCT00481195|147381219|SUPERIORITY_OR_OTHER|||||||0.3712||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3712
73926759|NCT00481195|147381220|SUPERIORITY_OR_OTHER|||||||0.5427||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.5427
73926760|NCT00481195|147381221|SUPERIORITY_OR_OTHER|||||||0.3463||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3463
73926761|NCT00481195|147381222|SUPERIORITY_OR_OTHER|||||||0.273||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2730
73926762|NCT00481195|147381223|SUPERIORITY_OR_OTHER|||||||0.7791||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.7791
73926763|NCT00481195|147381224|SUPERIORITY_OR_OTHER|||||||0.9007||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.9007
73926764|NCT00481195|147381225|SUPERIORITY_OR_OTHER|||||||0.6431||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.6431
73926765|NCT00481195|147381226|SUPERIORITY_OR_OTHER|||||||0.6631||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder.||||||0.6631
73926766|NCT00481195|147381227|SUPERIORITY_OR_OTHER|||||||0.9768||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.9768
73926767|NCT00481195|147381228|SUPERIORITY_OR_OTHER|||||||0.9873||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment fro bipolar disorder||||||0.9873
73926768|NCT00481195|147381229|SUPERIORITY_OR_OTHER|||||||0.4567||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.4567
73926769|NCT00481195|147381230|SUPERIORITY_OR_OTHER|||||||0.6475||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.6475
73926770|NCT00481195|147381231|SUPERIORITY_OR_OTHER|||||||0.5066||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.5066
73926771|NCT00481195|147381232|SUPERIORITY_OR_OTHER|||||||0.4438||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.4438
73926772|NCT03343483|147381233|SUPERIORITY||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|1.06||0.896|TWO_SIDED|95.0|-2.21|1.93|||Mixed Models Analysis|||||1.93|-2.21|.896
73926773|NCT03343483|147381234|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.8|TWO_SIDED||||||ANOVA|||||||0.80
73926774|NCT03343483|147381235|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
73926775|NCT03343483|147381236|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
73926776|NCT03343483|147381237|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
73926777|NCT03343483|147381238|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.57|TWO_SIDED||||||Mixed Models Analysis|||||||0.57
73926778|NCT03975647|147381245|OTHER||Hazard Ratio (HR)|0.759||||0.0163|TWO_SIDED|95.0|0.607|0.95|||Log Rank||HR was calculated from Cox proportional hazards model. (line of treatment for metastatic: first versus \[vs\] other; hormone receptor status: negative vs positive; presence or history of brain metastases: yes vs no; ECOG status: 0,1 at randomization.|||0.950|0.607|0.0163
73926779|NCT03975647|147381247|OTHER||Hazard Ratio (HR)|0.639||||0.0078|TWO_SIDED|95.0|0.459|0.891|||Log Rank||HR was calculated from Cox proportional hazards model. (line of treatment for metastatic: first versus \[vs\] other; hormone receptor status: negative vs positive; presence or history of brain metastases: yes vs no; ECOG status: 0,1 at randomization.|||0.891|0.459|0.0078
73926780|NCT03975647|147381248|OTHER|||||||0.2055|||||||Cochran-Mantel-Haenszel|||||||0.2055
73926781|NCT02404350|147381258|SUPERIORITY||Odds Ratio (OR)|4.02|||<|0.0001|TWO_SIDED|95.0|2.78|5.79|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||5.79|2.78|<0.0001
73926782|NCT02404350|147381258|SUPERIORITY||Odds Ratio (OR)|3.38|||<|0.0001|TWO_SIDED|95.0|2.35|4.87|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||4.87|2.35|<0.0001
73926783|NCT02404350|147381258|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|3.16|6.63|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||6.63|3.16|<0.0001
74029218|NCT04003155|147612897|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
74087625|NCT02740179|147729365|SUPERIORITY|||||||0.36||||||P value for Change in Plasma hsCRP|t-test, 2 sided|Analyses performed after log transformation of data||||||0.36
73926784|NCT02404350|147381259|SUPERIORITY||Difference in Mean|-0.61|STANDARD_ERROR_OF_MEAN|0.22||0.0061|TWO_SIDED||||||Non-parametric ANCOVA model||\*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0061
73969320|NCT05590403|147477841|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-6.67|||||TWO_SIDED|95.0|-12.26|-1.12|||||The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||-1.12|-12.26|
73969321|NCT05590403|147477842|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.71|0.91|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||0.91|0.71|
73969322|NCT05590403|147477843|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-7.31|||||TWO_SIDED|95.0|-13.52|-1.09|||||The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||-1.09|-13.52|
73969323|NCT03701399|147477879|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.7581|TWO_SIDED|95.0|-0.47|0.34|||Mixed Models Analysis||Model based summary statistics were from a mixed model with repeated measures, including fixed effects for treatment, randomization stratum (SCA genotype group), visit, treatment-by-visit interaction, and country, baseline score as a covariate|All SCA participants||0.34|-0.47|0.7581
73969324|NCT03701399|147477879|SUPERIORITY||Least square mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.28||0.045|TWO_SIDED|95.0|-1.11|-0.01|||Mixed Models Analysis||Model based summary statistics were from a mixed model with repeated measures, including fixed effects for treatment, randomization stratum (SCA genotype group), visit, treatment-by-visit interaction, and country.|SCA3 genotype participants||-0.01|-1.11|0.0450
73969325|NCT04342494|147477890|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PHQ-9 score via analysis of covariance.||||||0.31|||||||ANCOVA|||||||0.31
73969326|NCT04342494|147477891|EQUIVALENCE|Average mood score obtained from daily measurements analyzed via analysis of variance||||||0.0073|||||||ANOVA|||||||0.0073
73969327|NCT04342494|147477892|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PANSI-PI score via analysis of covariance||||||0.03|||||||ANCOVA|||||||0.03
73969328|NCT04342494|147477893|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PANSI-NSI score via analysis of covariance||||||0.71|||||||ANCOVA|||||||0.71
74087626|NCT02740179|147729366|SUPERIORITY|||||||0.88||||||P value for Change in Plasma MCP-1|t-test, 2 sided|Analyses performed after log transformation of data||||||0.88
73969329|NCT04342494|147477894|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline GAD-7 score via analysis of covariance||||||0.31|||||||ANCOVA|||||||0.31
73969330|NCT05119023|147477899|OTHER|||||||0.39||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language Severity and Characterization of learning: SRT Observational Learning Scores||||0.39
73969331|NCT05119023|147477899|OTHER||||||<|0.01||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language severity and Characterization of learning: AGL Observational Learning Scores||||<0.01
73969332|NCT05119023|147477899|OTHER|||||||0.95||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language severity and Characterization of learning: AGL Rule-based Learning Scores||||0.95
73969333|NCT05119023|147477900|OTHER|Sample underpowered for regression so correlation examined||||||0.36||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Attention and Characterization of learning: SRT Observational Learning Scores||||0.36
73969334|NCT05119023|147477900|OTHER|||||||0.09|||||||Pearson's correlation|The threshold for statistical significance was p = 0.05||Examination of Attention and Characterization of learning: AGL Observational Learning Scores||||0.09
73969335|NCT05119023|147477900|OTHER|||||||0.32||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Attention and Characterization of learning: AGL Rule Based Learning||||0.32
73969336|NCT05119023|147477901|OTHER|Sample underpowered for regression so correlation examined||||||0.64||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Working Memory and Characterization of learning: SRT Observational Learning Scores||||0.64
73969337|NCT05119023|147477901|OTHER|||||||0.01||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Working Memory and Characterization of learning: AGL Observational Learning Scores||||0.01
73969338|NCT05119023|147477901|OTHER|||||||0.79|||||||Pearson's correlation|||Examination of Working Memory and Characterization of learning: AGL Rule-based Learning Scores||||0.79
73969339|NCT05119023|147477902|OTHER|Sample underpowered for regression so correlation examined||||||0.9||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Executive Function and Characterization of learning: SRT Observational Learning Scores||||0.90
73969340|NCT05119023|147477902|OTHER|||||||0.09||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Executive Function and Characterization of learning: AGL Observational Learning Scores||||0.09
74087627|NCT02740179|147729367|SUPERIORITY|||||||0.17||||||P value for Change in Plasma sCD163|t-test, 2 sided|Analyses performed after log transformation of data||||||0.17
73862595|NCT03921554|147270917|SUPERIORITY||Estimated change (52 weeks - baseline)|2.2||||0.295|TWO_SIDED|95.0|-1.9|6.4||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||6.4|-1.9|0.295
73862596|NCT03921554|147270917|SUPERIORITY||Estimated change (52 weeks - baseline)|7.0||||0.007|TWO_SIDED|95.0|1.9|12.0||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||12.0|1.9|0.007
73862597|NCT03921554|147270917|SUPERIORITY||Estimated change (52 weeks - baseline)|0.26||||0.932|TWO_SIDED|95.0|-5.7|6.2||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||6.2|-5.7|0.932
73862598|NCT03921554|147270918|SUPERIORITY||Estimated change (Day 3 - Day 0)|-8.76|||<|0.0005|TWO_SIDED|95.0|-11.7|-5.81||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a QLS model of ISG on day of treatment and indicator variable for post-treatment. Goodness of fit criteria were used to select QLS model with exchangeable correlation structure.|We estimate change from pre to post treatment (Day 3 minus Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||-5.81|-11.7|<0.0005
73862599|NCT03921554|147270919|SUPERIORITY||Estimated change (day 335 minus day 0)|-0.11||||0.002|TWO_SIDED|95.0|-0.18|-0.04||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model of diary average score on day of treatment and indicator variable for post-treatment. Goodness of fit criteria were used to select GEE model with exchangeable correlation structure.|We estimate change from Day 0 to Day 335 (Day 335 - Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||-0.04|-0.18|0.002
73862600|NCT03859739|147270920|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.79|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 2.44 %.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
73862601|NCT03859739|147270920|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.97|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 7.60%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
73926785|NCT02404350|147381259|SUPERIORITY||Difference in Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.13||0.0048|TWO_SIDED||||||Non-parametric ANCOVA model||\*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0048
73926786|NCT02404350|147381259|SUPERIORITY||Difference in Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.13||0.0003|||||||Non-parametric ANCOVA model||For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0003
73969341|NCT05119023|147477902|OTHER|||||||0.24|||||||Pearson's correlation|||Examination of Executive Function and Characterization of learning: AGL Rule-based Learning Scores||||0.24
73969342|NCT04806451|147477916|SUPERIORITY||LS Mean Difference|-267.775|STANDARD_ERROR_OF_MEAN|68.313||0.0002|TWO_SIDED|95.0|-403.427|-132.124|||ANCOVA|||||-132.124|-403.427|0.0002
73969343|NCT05835336|147477923|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|7.45|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73862602|NCT03859739|147270920|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.58|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 74.99%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
74087628|NCT02740179|147729368|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|Analyses performed after log transformation of data||||||0.28
74087629|NCT02740179|147729369|SUPERIORITY|||||||0.32|||||||Kruskal-Wallis|||||||0.32
74087630|NCT02740179|147729370|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
73926787|NCT02404350|147381260|SUPERIORITY||Odds Ratio (OR)|10.15|||<|0.0001|TWO_SIDED|95.0|5.52|18.63|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||18.63|5.52|<0.0001
73926788|NCT02404350|147381260|SUPERIORITY||Odds Ratio (OR)|11.66|||<|0.0001|TWO_SIDED|95.0|6.37|21.37|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||21.37|6.37|<0.0001
73969344|NCT05835336|147477924|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
74087631|NCT02740179|147729371|SUPERIORITY|||||||0.73|||||||Kruskal-Wallis|||||||0.73
73926789|NCT02404350|147381260|SUPERIORITY||Odds Ratio (OR)|18.06|||<|0.0001|TWO_SIDED|95.0|9.56|34.12|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||34.12|9.56|<0.0001
73926790|NCT02404350|147381261|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.0001|TWO_SIDED|95.0|2.31|8.83|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||8.83|2.31|<0.0001
73926791|NCT02404350|147381261|SUPERIORITY||Odds Ratio (OR)|6.14|||<|0.0001|TWO_SIDED|95.0|3.18|11.87|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||11.87|3.18|<0.0001
73926792|NCT02404350|147381261|SUPERIORITY||Odds Ratio (OR)|12.55|||<|0.0001|TWO_SIDED|95.0|6.43|24.48|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||24.48|6.43|<0.0001
73926793|NCT02404350|147381262|SUPERIORITY||Odds Ratio, log|5.37|||<|0.0001|TWO_SIDED|95.0|3.3|8.73|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||8.73|3.30|<0.0001
73926794|NCT02404350|147381262|SUPERIORITY||Odds Ratio (OR)|6.37|||<|0.0001|TWO_SIDED|95.0|3.93|10.32|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||10.32|3.93|<0.0001
73926795|NCT02404350|147381262|SUPERIORITY||Odds Ratio (OR)|7.43|||<|0.0001|TWO_SIDED|95.0|4.61|12.0|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||12.00|4.61|<0.0001
73926796|NCT02404350|147381263|SUPERIORITY|Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure|Treatment contrast in LS mean (Change)|-0.24|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.32|-0.15|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.15|-0.32|<0.0001
73926797|NCT02404350|147381263|SUPERIORITY||Treatment Contrast in LS mean (Change)|-0.23|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.32|-0.14|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.14|-0.32|<0.0001
73926798|NCT02404350|147381263|SUPERIORITY||Treatment Contrast inj LS mean (Change)|-0.33|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.42|-0.24|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.24|-0.42|<0.0001
73926799|NCT02404350|147381264|SUPERIORITY||Treatment contrast in LS mean (Change)|-0.66|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.47|-0.85|<0.0001
73969345|NCT05835336|147477925|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|3.55||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
74087632|NCT02740179|147729372|SUPERIORITY|||||||0.56|||||||Kruskal-Wallis|||||||0.56
74087633|NCT02740179|147729373|SUPERIORITY|||||||0.03|||||||Kruskal-Wallis|||||||0.03
74087634|NCT02740179|147729374|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
74087635|NCT04625062|147729375|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.72|TWO_SIDED||||||paired t-test, two-tailed|df = 6|Traditional treatment condition - biofeedback treatment condition|||||.72
74087636|NCT03827018|147729378|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0263|TWO_SIDED|95.0|0.15|0.92||Comparison of KPL-301 and placebo with respect to time to flare calculated by using a log-rank test stratified by randomization strata.|Log Rank||95% confidence interval was calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata.|||0.92|0.15|0.0263
73926800|NCT02404350|147381264|SUPERIORITY||Treatment Contrast in LS Mean (Change)|-0.66|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.47|-0.85|<0.0001
73926801|NCT02404350|147381264|SUPERIORITY||Treatment contrast in LS mean (Change)|-0.86|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-1.05|-0.67|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.67|-1.05|<0.0001
73969346|NCT05835336|147477926|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|5.16||||0.032|TWO_SIDED||||||t-test, 2 sided|||||||0.032
73969347|NCT05835336|147477928|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|7.58||||0.035|TWO_SIDED||||||t-test, 2 sided|||||||0.035
73969348|NCT05835336|147477929|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|-1.13||||0.521|TWO_SIDED||||||t-test, 2 sided|||||||.521
73969349|NCT02023866|147477978|OTHER|||||||0.1875|||||||Wilcoxon Signed Rank|||Section I - Current Function Null hypothesis = change from baseline is 0.||||0.1875
73969350|NCT02023866|147477978|OTHER|||||||1|||||||Wilcoxin Signed Rank|||Section II - System Specific Involvement Null hypothesis = change from baseline is 0.||||1.0000
73969351|NCT02023866|147477978|OTHER|||||||0.0781|||||||Wilcoxin Signed Rank|||Section III - Current Clinical Assessment Null hypothesis = change from baseline is 0.||||0.0781
73969352|NCT02023866|147477978|OTHER|||||||0.2941|||||||t-test, 2 sided|One-sample t-test||Section IV - Quality of Life Null hypothesis = change from baseline is 0.||||0.2941
74029219|NCT04003155|147612898|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002||95.0|-0.39|-0.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.09|-0.39|0.002
74029220|NCT04003155|147612898|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.007||95.0|-0.35|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.06|-0.35|0.007
74029221|NCT04003155|147612898|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
74087637|NCT03827018|147729379|SUPERIORITY||Difference in proportions|33.3||||0.0038|TWO_SIDED|95.0|10.7|55.8||Two-sided p-value and 95% CI for the difference in sustained remission between two arms using normal approximation. Placebo arm is the reference.|normal approximation|||Secondary endpoints were analyzed in hierarchical order.||55.8|10.7|0.0038
73926802|NCT02404350|147381265|SUPERIORITY||Odds Ratio (OR)|0.75||||0.225|TWO_SIDED|95.0|0.47|1.19|||Regression, Logistic|||||1.19|0.47|0.2250
73926803|NCT02404350|147381265|SUPERIORITY||Odds Ratio (OR)|0.45||||0.0004|TWO_SIDED|95.0|0.29|0.7|||Regression, Logistic|||||0.70|0.29|0.0004
73926804|NCT02404350|147381265|SUPERIORITY||Odds Ratio, log|0.44||||0.0004|TWO_SIDED|95.0|0.28|0.69|||Regression, Logistic|||||0.69|0.28|0.0004
73926805|NCT02404350|147381266|SUPERIORITY||Odds Ratio (OR)|0.37||||0.0004|TWO_SIDED|95.0|0.22|0.65|||Regression, Logistic|||||0.65|0.22|0.0004
73926806|NCT02404350|147381266|SUPERIORITY||Odds Ratio (OR)|0.34||||0.0003|TWO_SIDED|95.0|0.19|0.6|||Regression, Logistic|||||0.60|0.19|0.0003
73926807|NCT02404350|147381266|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.13|0.44|||Regression, Logistic|||||0.44|0.13|<0.0001
73926808|NCT04007523|147381339|OTHER|Fisher's Exact Test||||||0.653|||||||Fisher Exact|||||||0.653
73926809|NCT04007523|147381339|OTHER|Fisher's Exact Test||||||0.614|||||||Fisher Exact|||||||0.614
73969353|NCT05210608|147478051|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.55||0.29|TWO_SIDED|95.0|-0.85|2.18||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||We analyzed whether significant changes occurred between baseline and the post-treatment assessment.||2.18|-.85|.29
73969354|NCT05210608|147478051|SUPERIORITY||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.45||0.48|TWO_SIDED|95.0|-3.45|5.79||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||We analyzed whether significant changes occurred between baseline and the 1 month follow up||5.79|-3.45|.48
73969355|NCT05210608|147478052|SUPERIORITY||Mean Difference (Final Values)|37.7|STANDARD_ERROR_OF_MEAN|14.8|=|0.015|TWO_SIDED|95.0|19.9|102.1||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||We analyzed whether there were significant differences in number of total cigarettes smoked per week from baseline to Post-treatment.||102.10|19.90|=0.015
73969356|NCT05210608|147478052|SUPERIORITY||Mean Difference (Final Values)|17.03|STANDARD_ERROR_OF_MEAN|24.69||0.08|TWO_SIDED|95.0|-14.57|142.57|||t-test, 2 sided|||We analyzed whether there were significant differences in number of total cigarettes smoked per week from baseline to 1 month follow-up.||142.57|-14.57|.08
73969357|NCT05210608|147478053|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|3.64||0.9|TWO_SIDED|95.0|-9.86|8.86|||t-test, 2 sided|||We analyzed whether there were significant differences in carbon monoxide ppm from baseline to Post-treatment.||8.86|-9.86|.90
73969358|NCT05210608|147478053|SUPERIORITY||Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|11.29||0.32|TWO_SIDED|95.0|-49.42|22.42|||t-test, 2 sided|||We analyzed whether there were significant difference in carbon monoxide ppm from baseline to the 1 month follow-up.||22.42|-49.42|.32
74029222|NCT04003155|147612898|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
73926810|NCT04007523|147381339|OTHER|Fisher's Exact Test||||||0.999|||||||Fisher Exact|||||||0.999
73926811|NCT04652479|147381361|OTHER|||||||0.0028||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0028
73926812|NCT04652479|147381361|OTHER|||||||0.0005||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0005
73926813|NCT04652479|147381362|OTHER|||||||0.0027||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0027
73926814|NCT04652479|147381362|OTHER|||||||0.0043||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0043
73926815|NCT04652479|147381363|OTHER|||||||0.0003||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0003
74087638|NCT03827018|147729380|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0277|TWO_SIDED|95.0|0.27|0.95||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||0.95|0.27|0.0277
74087639|NCT03827018|147729381|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.0378|TWO_SIDED|95.0|0.19|0.98||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||0.98|0.19|0.0378
73926816|NCT04652479|147381363|OTHER|||||||0.0003||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0003
73926817|NCT04652479|147381364|OTHER|||||||0.161||||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Between-group analysis of change from baseline||||0.161
73926818|NCT04652479|147381364|OTHER||Mean Difference (Net)|-35.66||||0.201|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Within-group analysis of change from baseline||||0.201
73926819|NCT04652479|147381364|OTHER||Mean Difference (Net)|-67.65||||0.001|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Within-group analysis of change from baseline||||0.001
73926820|NCT04652479|147381365|OTHER|||||||0.145||||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Between-group analysis of change from baseline||||0.145
73926821|NCT04652479|147381365|OTHER||Mean Difference (Net)|-31.88||||0.111|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided||Change in percentage|Within-group analysis of change from baseline||||0.111
73926822|NCT04652479|147381365|OTHER||Mean Difference (Net)|-53.37||||0.001|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided||Change in percentage|Within-group analysis of change from baseline||||0.001
73926823|NCT05544786|147381369|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|113.13|||||TWO_SIDED|90.0|102.77|124.53|||||The ratios (and 90% confidence Intervals \[CIs\]) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||124.53|102.77|
73926824|NCT05544786|147381369|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|121.91|||||TWO_SIDED|90.0|110.75|134.2|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||134.20|110.75|
73926825|NCT05544786|147381369|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|125.49|||||TWO_SIDED|90.0|114.43|137.61|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||137.61|114.43|
73926826|NCT05544786|147381369|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|121.09|||||TWO_SIDED|90.0|110.42|132.79|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||132.79|110.42|
73926827|NCT05544786|147381370|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|113.62|||||TWO_SIDED|90.0|102.96|125.4|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||125.40|102.96|
73926828|NCT05544786|147381370|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|122.53|||||TWO_SIDED|90.0|111.02|135.22|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||135.22|111.02|
73926829|NCT05544786|147381370|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|126.55|||||TWO_SIDED|90.0|115.0|139.27|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||139.27|115.00|
73969359|NCT05210608|147478054|SUPERIORITY||Mean Difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|4.36||0.18|TWO_SIDED|95.0|-5.1|19.1|||t-test, 2 sided|||We analyzed whether there were significant differences in working memory scores from baseline to post-treatment.||19.10|-5.10|.18
73926830|NCT05544786|147381370|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|122.28|||||TWO_SIDED|90.0|111.11|134.57|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||134.57|111.11|
73926831|NCT05544786|147381371|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|110.28|||||TWO_SIDED|90.0|99.01|122.82|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||122.82|99.01|
73926832|NCT05544786|147381371|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|140.97|||||TWO_SIDED|90.0|126.57|157.01|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||157.01|126.57|
73926833|NCT05544786|147381371|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|149.83|||||TWO_SIDED|90.0|132.86|168.96|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||168.96|132.86|
73926834|NCT05544786|147381371|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|147.05|||||TWO_SIDED|90.0|130.4|165.83|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||165.83|130.40|
73926835|NCT05544786|147381372|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|96.76|||||TWO_SIDED|90.0|87.31|107.23|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||107.23|87.31|
73926836|NCT05544786|147381372|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|86.86|||||TWO_SIDED|90.0|78.38|96.26|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||96.26|78.38|
74087640|NCT03827018|147729382|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0651|TWO_SIDED|95.0|0.22|1.06||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||1.06|0.22|0.0651
74087641|NCT03827018|147729383|OTHER|Descriptive statistic|Least Squares (LS) means difference|-326.45||||0.0667|TWO_SIDED|95.0|-675.99|23.09||Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable.|ANCOVA|||||23.09|-675.99|0.0667
73926837|NCT05544786|147381372|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|99.29|||||TWO_SIDED|90.0|87.39|112.8|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||112.80|87.39|
73926838|NCT05544786|147381372|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|79.29|||||TWO_SIDED|90.0|70.07|89.73|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||89.73|70.07|
73926839|NCT05544786|147381373|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|95.92|||||TWO_SIDED|90.0|86.45|106.44|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||106.44|86.45|
73926840|NCT05544786|147381373|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|86.5|||||TWO_SIDED|90.0|77.96|95.98|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||95.98|77.96|
74029223|NCT04003155|147612899|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.8||0.489||95.0|-2.0|1.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||1.0|-2.0|0.489
74029224|NCT04003155|147612899|SUPERIORITY||LSMean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.155||95.0|-2.5|0.4||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.4|-2.5|0.155
73862603|NCT03859739|147270920|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.78|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 87.41%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
73862604|NCT03859739|147270928|OTHER||Standard Error (SE)|0.146|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 0.25%.|The posterior probability (PP) that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
73862605|NCT03859739|147270928|OTHER||SE|0.146|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 65.41%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
73862606|NCT03859739|147270928|OTHER||SE|0.133|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 99.99%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
73862607|NCT03859739|147270928|OTHER||SE|0.163|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 99.98%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
73862608|NCT00689793|147271005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|2.5||0.69|TWO_SIDED|95.0|0.0|10.0||Significant level of treatment effect was set at p\<0.05|Regression, Linear|Level of fatigue at four weeks:dependant variable. Group allocation and level of fatigue at baseline: independant variables.||The null hypothesis was that there was no difference in fatigue VAS scores between the treatment and placebo groups at 4 weeks||10|0|0.69
73862609|NCT00689793|147271006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|6.5|<|0.05||95.0|0.0|10.0|||Regression, Linear|Hemoglobin value at four weeks : dependant variable. Group allocation and hemoglobin value at baseline : independant variables.||||10|0|<0.05
73862610|NCT00689793|147271007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|8.0|<|0.05|TWO_SIDED|95.0|0.0|30.0|||Regression, Linear|Ferritin level at 4 weeks : dependant variable. Group allocation and ferritin level at baseline: independant variables.||||30|0|<0.05
73862611|NCT00689793|147271008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|3.0||0.05|TWO_SIDED|95.0|0.0|6.0|||Regression, Linear|Aerobic capacity at 4 weeks : dependant variables. Group allocation and aerobic capacity at baseline : independant variable.||||6|0|0.05
73862612|NCT03968159|147271011|SUPERIORITY||LSM difference|-0.9|STANDARD_ERROR_OF_MEAN|0.82||0.2956|TWO_SIDED|95.0|-2.5|0.8|||Mixed-effects model for repeated measure|||||0.8|-2.5|0.2956
73862613|NCT01842581|147271034|NON_INFERIORITY|Threshold for significance=upper bound of the 2-sided 95% confidence interval (CI) for hazard ratio less than (\<) 1.56.|Hazard Ratio (HR)|1.959||||0.0359|TWO_SIDED|95.0|1.045|3.672|||Score statistics|||Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.||3.672|1.045|0.0359
73926841|NCT05544786|147381373|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|88.29|||||TWO_SIDED|90.0|72.97|106.83|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||106.83|72.97|
73926842|NCT05544786|147381373|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|77.49|||||TWO_SIDED|90.0|64.04|93.76|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||93.76|64.04|
73926843|NCT05544786|147381374|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|101.92|||||TWO_SIDED|90.0|87.71|118.44|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||118.44|87.71|
73926844|NCT05544786|147381374|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|92.4|||||TWO_SIDED|90.0|79.52|107.38|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||107.38|79.52|
73926845|NCT05544786|147381374|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|97.04|||||TWO_SIDED|90.0|78.4|120.1|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||120.10|78.40|
73926846|NCT05544786|147381374|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|70.45|||||TWO_SIDED|90.0|56.92|87.19|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||87.19|56.92|
73926847|NCT05544786|147381375|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|96.5|||||TWO_SIDED|90.0|90.08|103.37|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||103.37|90.08|
73926848|NCT05544786|147381376|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|96.63|||||TWO_SIDED|90.0|90.13|103.59|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||103.59|90.13|
73926849|NCT05544786|147381377|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|98.15|||||TWO_SIDED|90.0|87.28|110.36|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||110.36|87.28|
73926850|NCT05544786|147381378|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|78.49|||||TWO_SIDED|90.0|72.42|85.07|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||85.07|72.42|
73926851|NCT05544786|147381379|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|87.77|||||TWO_SIDED|90.0|69.45|110.92|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||110.92|69.45|
73926852|NCT05544786|147381380|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|72.6|||||TWO_SIDED|90.0|56.87|92.68|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||92.68|56.87|
73926853|NCT01774786|147381413|SUPERIORITY|The study was designed to have 80% power to show a significant difference with respect to the primary endpoint.|Hazard Ratio (HR)|0.84||||0.0565|TWO_SIDED|95.0|0.71|1.0||The actual p-value significance threshold required for OS was 0.0455, after alpha spent at the interim analysis was taken into account.|Stratified Log-Rank|Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|HR was calculated as pertuzumab arm vs. placebo arm.|Primary Analysis. The null hypothesis is that the survival distribution of OS is the same in the two treatment arms.||1.00|0.71|0.0565
73926854|NCT01774786|147381413|OTHER|Exploratory|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.72|0.99|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Final Analysis||0.99|0.72|
73862614|NCT01842581|147271035|SUPERIORITY|2-sided test at a significance level of 0.05.|Hazard Ratio (HR)|1.739||||0.0985|TWO_SIDED|95.0|0.894|3.382||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by analysis region. Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.||3.382|0.894|0.0985
73926855|NCT01774786|147381414|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.62|0.86||As pre-specified in the protocol, a p-value was only to be calculated for PFS if OS was statistically significant.|||A stratified Cox proportional hazards regression model was used to estimate the HR between the pertuzumab arm vs. the placebo arm.|Primary Analysis||0.86|0.62|
73926856|NCT01774786|147381414|OTHER|Exploratory|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.62|0.85|||||A stratified Cox proportional hazards regression model was used to estimate the HR between the pertuzumab arm vs. the placebo arm.|Final Analysis||0.85|0.62|
73926857|NCT01774786|147381415|OTHER|Exploratory|Difference in Objective Response|8.4|||||TWO_SIDED|95.0|0.89|15.91|||||Difference in objective response was calculated as the pertuzumab arm minus placebo arm.|Primary Analysis of Objective Response Rate||15.91|0.89|
73926858|NCT01774786|147381415|OTHER|Exploratory|Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.04|1.89|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|Primary Analysis of Objective Response Rate||1.89|1.04|
73926859|NCT01774786|147381416|OTHER|Exploratory|Difference in Objective Response|8.4|||||TWO_SIDED|95.0|0.89|15.91|||||Difference in objective response was calculated as the pertuzumab arm minus placebo arm.|Final Analysis of Objective Response Rate||15.91|0.89|
74087642|NCT03827018|147729384|OTHER|Descriptive statistic|Difference in percentages|31.0||||0.0201|TWO_SIDED|95.0|11.1|50.8||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||50.8|11.1|0.0201
74087643|NCT03827018|147729385|OTHER|Descriptive statistic|Difference in percentages|9.5||||0.5533|TWO_SIDED|95.0|-8.7|27.8||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||27.8|-8.7|0.5533
74087644|NCT03827018|147729386|OTHER|Descriptive statistics|Difference in percentages|39.3||||0.0031|TWO_SIDED|95.0|17.2|61.3||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||61.3|17.2|0.0031
74087645|NCT03827018|147729387|OTHER|Descriptive statistics|Least Squares (LS) means difference|-380.82||||0.1629|TWO_SIDED|95.0|-919.66|158.02||Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable|ANCOVA|||||158.02|-919.66|0.1629
74087646|NCT00605917|147729415|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was starting dose. The null hypothesis is there is no difference between three types of starting dose in the participants of responders."||||<0.001
74087647|NCT00605917|147729416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.002
74087648|NCT00605917|147729417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was family history of psychiatric disorder. The null hypothesis is there is no difference between with and without family history of psychiatric disorder in the participants of responders."||||0.032
74087649|NCT00605917|147729418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was smoking status. The null hypothesis is there is no difference between three types of smoking status in the participants of responders."||||<0.001
74087650|NCT00605917|147729419|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||<0.001
74087651|NCT00605917|147729420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with and without non-pharmaceutical therapies in the participants of responders."||||0.001
74087652|NCT00605917|147729421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was history of treatment prior to administration of Sertraline. The null hypothesis is there is no difference between with and without history of treatment prior to administration of Sertraline in the participants of responders."||||0.028
74087653|NCT00605917|147729422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."||||<0.001
73926860|NCT01774786|147381416|OTHER|Exploratory|Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.04|1.89|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|Final Analysis of Objective Response Rate||1.89|1.04|
73926861|NCT01774786|147381417|OTHER|Exploratory|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.64|1.06|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Primary Analysis||1.06|0.64|
73926862|NCT01774786|147381417|OTHER|Exploratory|Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.62|0.98|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Final Analysis||0.98|0.62|
74087654|NCT00605917|147729423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED|||||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."|Chi-squared|not adjusted, p=0.050||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."||||0.030
73926863|NCT01774786|147381418|OTHER|Exploratory|Difference in Clinical Benefit Rate|3.37|||||TWO_SIDED|95.0|-2.34|9.07|||||Difference in clinical benefit rate was calculated as the pertuzumab arm minus placebo arm.|||9.07|-2.34|
73926864|NCT01774786|147381418|OTHER|Exploratory|Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.86|1.88|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|||1.88|0.86|
74087655|NCT00605917|147729424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.013
74087656|NCT00605917|147729425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."||||0.004
74087657|NCT00605917|147729426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was drinking status. The null hypothesis is there is no difference between five types of drinking status in the participants of responders."||||0.004
73926865|NCT03556579|147381427|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-1.01|-0.36|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Without Distance Filter||-0.36|-1.01|
73969360|NCT05210608|147478054|SUPERIORITY||Mean Difference (Final Values)|-12.64|STANDARD_ERROR_OF_MEAN|5.14||0.18|TWO_SIDED|95.0|-25.38|7.38|||t-test, 2 sided|||We analyzed whether there were significant differences in working memory scores from baseline to the 1 month follow up.||7.38|-25.38|.18
74087658|NCT02443545|147729461|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.0000
74087659|NCT02443545|147729461|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.0000
74087660|NCT02443545|147729461|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.0000
74087661|NCT02443545|147729462|OTHER|One-sample t-test, to determine whether the change from baseline in MRI T2\* was significantly different from 0.||||||0.3146|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.3146
74087662|NCT02443545|147729462|OTHER|One-sample t-test, to determine whether the change from baseline in MRI T2\* was significantly different from 0.||||||0.9454|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.9454
74087663|NCT02443545|147729462|OTHER|One-sample t-test, to determine whether the change from baseline in MRI 2\* was significantly different from 0.||||||0.4336|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.4336
74087664|NCT02443545|147729463|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.9952|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.9952
74087665|NCT02443545|147729463|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.0008|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.0008
74087666|NCT02443545|147729463|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.042|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.0420
74087667|NCT00536484|147729465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002||95.0|-1.1|-0.4||Significance level p \<0.05|ANCOVA|Terms for treatment, center and baseline as covariate and baseline by treatment interaction.|The LS mean difference \& 95% CI were calculated at mean baseline = 12.9 (centered baseline used in model)|Null hypothesis: the mean change from baseline in micturitions per 24 hours in the fesoterodine group is the same as in the placebo group at Week 12. A sample size of 350 in each arm had at least 85% power to detect a difference of 0.8 between flexible dose fesoterodine \& placebo assuming a standard deviation of 3.52 using a 2-sample t-test with a 0.05 2-sided significance level. Accounting for 10% of randomized subjects not having the primary endpoint data, 390 subjects were needed in each arm||-0.4|-1.1|0.0002
74087668|NCT00536484|147729466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0136||95.0|-0.8|-0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment, baseline covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline||-0.1|-0.8|0.0136
74087669|NCT00536484|147729466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002||95.0|-1.1|-0.3||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline||-0.3|-1.1|0.0002
74087670|NCT00536484|147729467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1057||95.0|-0.9|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||0.1|-0.9|0.1057
74087671|NCT00536484|147729467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0338||95.0|-1.1|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-0.0|-1.1|0.0338
74087672|NCT00536484|147729467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0003||95.0|-1.5|-0.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.5|-1.5|0.0003
73862615|NCT00353873|147271040|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|7.6|STANDARD_ERROR_OF_MEAN|3.01||0.012|TWO_SIDED|95.0|1.7|13.5|||ANCOVA|||||13.5|1.7|0.012
73969361|NCT05851573|147478080|OTHER||||||<|0.05|||||||t-test, 2 sided|df = 9||||||< .05
73969362|NCT05851573|147478081|OTHER||||||=|0.775|||||||t-test, 2 sided|df = 9||||||= .775
74087673|NCT00536484|147729468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1666||95.0|-0.6|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||0.1|-0.6|0.1666
74087674|NCT00536484|147729468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0506||95.0|-0.8|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||0.0|-0.8|0.0506
73862616|NCT00353873|147271041|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|9.3|STANDARD_ERROR_OF_MEAN|3.08||0.003|TWO_SIDED|95.0|3.2|15.3|||ANCOVA|||||15.3|3.2|0.003
73862617|NCT00353873|147271042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.389|TWO_SIDED|95.0|0.7|2.4|||Regression, Logistic|||||2.4|0.7|0.389
73862618|NCT00353873|147271043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.535|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||||1.9|0.7|0.535
73862619|NCT00530920|147271053|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.43||||0.997|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||0.997
73862620|NCT00530920|147271053|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.55||||1|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||1
73862621|NCT00530920|147271053|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.47||||0.998|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||0.998
73926866|NCT03556579|147381427|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-1.45|-0.81|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Without Distance Filter||-0.81|-1.45|
73926867|NCT03556579|147381428|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-8.86|STANDARD_ERROR_OF_MEAN|2.173|||TWO_SIDED|95.0|-13.16|-4.55|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-4.55|-13.16|
73926868|NCT03556579|147381428|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-24.93|STANDARD_ERROR_OF_MEAN|2.173|||TWO_SIDED|95.0|-29.24|-20.62|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-20.62|-29.24|
73969363|NCT05851573|147478082|OTHER||||||=|0.444|||||||t-test, 2 sided|df = 10||||||= .444
73969364|NCT05851573|147478083|OTHER|||||||0.959|||||||t-test, 2 sided|df = 9||||||.959
73862622|NCT00707746|147271074|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||It was estimated that the standard deviation of the percent change in LDL-C was 20%. A sample size of 30 patients was planned for this study: 20 patients in the mipomersen group and 10 patients in the placebo group. A 2-sided t-test with an alpha level of 0.05 was expected to provide ≥90% power to detect a 30% difference in LDL-C percent reduction between the 2 groups (35% reduction for the mipomersen group and 5% reduction for the placebo group).||||<0.001
73862623|NCT00707746|147271077|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon signed rank sum|||||||<0.001
73862624|NCT00707746|147271079|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
73862625|NCT00707746|147271081|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
73969365|NCT05851573|147478084|OTHER|||||||0.068|||||||t-test, 2 sided|df = 9||||||.068
73969366|NCT05851573|147478085|OTHER||||||=|0.119|||||||t-test, 2 sided|df = 10||||||= .119
73969367|NCT05851573|147478086|OTHER||||||=|0.258|||||||t-test, 2 sided|df = 10||||||= .258
73862626|NCT00707746|147271083|SUPERIORITY_OR_OTHER|||||||0.005||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.005
73862627|NCT00707746|147271085|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
73862628|NCT00707746|147271087|SUPERIORITY_OR_OTHER|||||||0.006||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.006
73969368|NCT05851573|147478087|OTHER||||||=|0.593|||||||t-test, 2 sided|df = 10||||||= .593
73969369|NCT04114877|147478088|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
73969370|NCT04114877|147478089|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
73969371|NCT04114877|147478090|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
73969372|NCT04114877|147478091|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
73969373|NCT04114877|147478092|SUPERIORITY|||||||0.455|||||||Fisher Exact|||||||0.455
73969374|NCT04295798|147478093|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.02|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to gait speed from baseline to immediately post intervention.||||0.02
73862629|NCT00707746|147271089|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
73926869|NCT03556579|147381429|SUPERIORITY|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.15|0.23|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||0.23|0.15|
73862630|NCT00707746|147271091|SUPERIORITY_OR_OTHER|||||||0.784||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.784
73969375|NCT04295798|147478094|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.02|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to standing postural sway speed from baseline to immediately post intervention.||||0.02
74087675|NCT00536484|147729468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0014||95.0|-1.0|-0.2||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.2|-1.0|0.0014
74087676|NCT00536484|147729469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.2054||95.0|-0.4|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline||0.1|-0.4|0.2054
74087677|NCT00536484|147729469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0225||95.0|-0.6|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline||-0.0|-0.6|0.0225
74087678|NCT00536484|147729469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0167||95.0|-0.6|-0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline||-0.1|-0.6|0.0167
74087679|NCT00536484|147729470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8019||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 2 minus Baseline||0.1|-0.2|0.8019
74087680|NCT00536484|147729470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3881||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 6 minus Baseline||0.1|-0.2|0.3881
74087681|NCT00536484|147729470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.324||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 12 minus Baseline||0.1|-0.2|0.3240
74087682|NCT00536484|147729471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8279||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 2 minus Baseline||0.1|-0.2|0.8279
74087683|NCT00536484|147729471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5059||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 6 minus Baseline||0.1|-0.2|0.5059
74087684|NCT00536484|147729471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0806||95.0|-0.4|0.0||Significance level p \<0.05|ANOVA|||Week 12 minus Baseline||0.0|-0.4|0.0806
74087685|NCT00536484|147729472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0203||95.0|-3.2|-0.3||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||-0.3|-3.2|0.0203
74087686|NCT00536484|147729472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.8||0.0007||95.0|-4.2|-1.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-1.1|-4.2|0.0007
74087687|NCT00536484|147729472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-4.9|-1.7||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-1.7|-4.9|<0.0001
74087688|NCT00536484|147729473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001||95.0|-10.7|-4.9||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline||-4.9|-10.7|<0.0001
74087689|NCT00536484|147729474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001||95.0|5.3|11.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Concern domain"||11.5|5.3|<0.0001
74087690|NCT00536484|147729474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001||95.0|3.9|10.2||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Coping domain"||10.2|3.9|<0.0001
73862631|NCT00707746|147271093|SUPERIORITY_OR_OTHER|||||||0.079||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.079
73862632|NCT05260333|147271097|OTHER||correlation coefficient|0.81||||0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0001
73862633|NCT01075971|147271145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|||<|0.0001|TWO_SIDED|95.0|1.35|2.19||Analysis of variance with repeated measurements (daily scores from day 1 to day 5) for the whole set of patients was performed adjusted on the formulation (SL vs. FDT). Other independent factors were the subject and the day.|Analysis of variance|||||2.19|1.35|<0.0001
73969376|NCT04295798|147478095|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.04|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to stride time variability from baseline to immediately post intervention.||||0.04
73969377|NCT04295798|147478096|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.56|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task gait speed from baseline to immediately post intervention.||||0.56
73969378|NCT04295798|147478097|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.07|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task gait speed from baseline to immediately post intervention.||||0.07
73969379|NCT04295798|147478098|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.74|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task stride time variability from baseline to immediately post intervention.||||0.74
73969380|NCT04295798|147478099|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.33|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task stride time variability from baseline to immediately post intervention.||||0.33
73969381|NCT04295798|147478100|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.16|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to standing postural sway area from baseline to immediately post intervention.||||0.16
73969382|NCT04295798|147478101|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.52|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task postural sway speed from baseline to immediately post intervention.||||0.52
74029225|NCT04003155|147612900|SUPERIORITY||LSMean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.53|-1.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-1.09|-2.53|<0.001
74029226|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-1.25|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-1.97|-0.53||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.53|-1.97|<0.001
74029227|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.75|-1.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.19|-2.75|<0.001
74029228|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.6|-1.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.05|-2.60|<0.001
74029229|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.79|-1.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.19|-2.79|<0.001
74087691|NCT00536484|147729474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.6||0.0036||95.0|1.5|7.8||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate||"Week 12 minus Baseline~Sleep domain"||7.8|1.5|0.0036
74029230|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.9|-1.31||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.31|-2.90|<0.001
74087692|NCT00536484|147729474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0007||95.0|1.6|5.8||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Social interaction domain"||5.8|1.6|0.0007
73862634|NCT02827500|147271164|SUPERIORITY||Odds Ratio, log|5.19||||0.002|TWO_SIDED|95.0|1.88|14.33|||Regression, Logistic|||||14.33|1.88|0.002
73926870|NCT03556579|147381430|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Ratio|0.55|||||TWO_SIDED|95.0|0.46|0.65|||Generalized linear mixed model|Generalized Linear mixed model with a lognormal distribution using the Kenward and Roger method for the denominator degrees of freedom.||||0.65|0.46|
73926871|NCT03556579|147381431|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-1.07|-0.15|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||-0.15|-1.07|
73926872|NCT03556579|147381432|SUPERIORITY|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.14|0.23|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||0.23|0.14|
73862635|NCT02827500|147271165|SUPERIORITY|||||||0.011|||||||Regression, Linear|||||||0.011
73969383|NCT04295798|147478102|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.01|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task postural sway speed from baseline to immediately post intervention.||||0.01
73862636|NCT02827500|147271166|SUPERIORITY|||||||0.011|||||||Regression, Linear|||The null hypothesis tested was that there is no difference in change in heart rate between the treatment arms.||||0.011
73926873|NCT03556579|147381433|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-30.56|STANDARD_ERROR_OF_MEAN|2.555|||TWO_SIDED|95.0|-31.66|-25.46|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control.|||-25.46|-31.66|
73862637|NCT02827500|147271167|SUPERIORITY|||||||0.054||||||The apriori threshold for statistical significance is alpha=0.05.|Chi-squared, Corrected|The p-value is obtained using the F-test (combination of Chi-Squared tests) due to multiple imputation.||The null hypothesis tested was that there is no difference between the treatment arms in the proportion of patients with heart rate \< 70 BPM.||||0.054
73862638|NCT02827500|147271168|SUPERIORITY|||||||0.717|||||||Regression, Linear|||||||0.717
73926874|NCT03556579|147381433|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-15.38|STANDARD_ERROR_OF_MEAN|2.555|||TWO_SIDED|95.0|-20.48|-10.27|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test Minus Control.|||-10.27|-20.48|
73926875|NCT00744627|147381442|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.81|STANDARD_ERROR_OF_MEAN|0.981|<|0.001|TWO_SIDED|95.0|-5.74|-1.88||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||-1.88|-5.74|<0.001
73926876|NCT00744627|147381443|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.555|<|0.001|TWO_SIDED|95.0|-3.39|-1.2||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis||||-1.20|-3.39|<0.001
74087693|NCT00536484|147729474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001||95.0|3.6|8.9||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~HRQL scale score total"||8.9|3.6|<0.0001
74087694|NCT00536484|147729475|SUPERIORITY_OR_OTHER|||||||0.0087||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2||||0.0087
74087695|NCT00536484|147729475|SUPERIORITY_OR_OTHER|||||||0.0008||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6||||0.0008
74087696|NCT00536484|147729475|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12||||0.0006
74087697|NCT00536484|147729476|SUPERIORITY_OR_OTHER|||||||0.0129||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2||||0.0129
74087698|NCT00536484|147729476|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6||||0.0100
74087699|NCT00536484|147729476|SUPERIORITY_OR_OTHER|||||||0.0009||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12||||0.0009
74087700|NCT00536484|147729477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.9|-0.4||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||-0.4|-0.9|<0.0001
74087701|NCT00536484|147729477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.1|-0.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-0.5|-1.1|<0.0001
74087702|NCT00536484|147729477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.3|-0.7||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.7|-1.3|<0.0001
74087703|NCT01506908|147729478|SUPERIORITY_OR_OTHER||Least squares means difference|-15.9|||<|0.0001|TWO_SIDED|95.0|-21.6|-10.2|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 5 minutes||-10.2|-21.6|<0.0001
74087704|NCT01506908|147729479|SUPERIORITY_OR_OTHER||Least squares means difference|-4.2||||0.0511|TWO_SIDED|95.0|-8.4|0.0|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 1 minute.||0.0|-8.4|0.0511
74087705|NCT01506908|147729480|SUPERIORITY_OR_OTHER||Least squares means difference|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.7|-6.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 3 minutes.||-6.4|-16.7|<0.0001
74087706|NCT01506908|147729481|SUPERIORITY_OR_OTHER||Least squares means difference|-17.8|||<|0.0001|TWO_SIDED|95.0|-23.8|-11.7|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 7 minutes.||-11.7|-23.8|<0.0001
73862639|NCT02827500|147271169|SUPERIORITY|||||||0.784|||||||Regression, Linear|||||||0.784
73926877|NCT00744627|147381444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|-0.73|-0.19||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-0.19|-0.73|<0.001
73926878|NCT00744627|147381445|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.901||0.031|TWO_SIDED|95.0|-3.74|-0.18||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-0.18|-3.74|0.031
74029231|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.87|-1.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.27|-2.87|<0.001
74029232|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.18|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.98|-1.39||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.39|-2.98|<0.001
74029233|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.11|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.92|-1.3||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.30|-2.92|<0.001
74029234|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-3.19|-1.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.59|-3.19|<0.001
74029235|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-2.95|-1.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.25|-2.95|<0.001
74029236|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.27|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.11|-1.42||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.42|-3.11|<0.001
74087707|NCT01506908|147729482|SUPERIORITY_OR_OTHER||Least square mean difference|-17.9|||<|0.0001|TWO_SIDED|95.0|-24.4|-11.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 10 minutes.||-11.4|-24.4|<0.0001
74087708|NCT00562120|147729516|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED|||||P-value was based on one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.302
73926879|NCT00744627|147381446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.393|||<|0.001|TWO_SIDED|95.0|1.496|3.83||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||3.830|1.496|<0.001
74029237|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.25|-1.54||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.54|-3.25|<0.001
74029238|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.23|-1.55||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.55|-3.23|<0.001
74087709|NCT00562120|147729516|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.134
74029239|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-2.93|-1.22||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.22|-2.93|<0.001
74029240|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.0|-1.31||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.31|-3.00|<0.001
74029241|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.21|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.05|-1.37||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.37|-3.05|<0.001
74029242|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.98|-1.33||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.33|-2.98|<0.001
74029243|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.34|-1.62||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.62|-3.34|<0.001
73969384|NCT04295798|147478103|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.39|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task postural sway area from baseline to immediately post intervention||||0.39
73969385|NCT04295798|147478104|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.18|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task postural sway area from baseline to immediately post intervention.||||0.18
73969386|NCT06429319|147478105|SUPERIORITY||F value|5.919||||0.004|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of one and two NOLTREX™ courses was used ANCOVA adjusted for the baseline value with fixed factor of treatment group."||No sample size calculation was performed. Maximum expected number of participants for OLE was 72 patients randomized to the NOLTREX™ group in the parent study (IA/PAAG-SI/OA/2019). A total of 65 patients entered the OLE. The study did not have a formal hypothesis. The between-group comparison of changes from baseline (OLE visit 0) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.004
74029244|NCT04003155|147612900|SUPERIORITY||LSMean Difference|-2.45|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.3|-1.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.60|-3.30|<0.001
74029245|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.006|TWO_SIDED|95.0|-0.17|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.03|-0.17|0.006
74029246|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.006|TWO_SIDED|95.0|-0.17|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.03|-0.17|0.006
74029247|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.05||0.003|TWO_SIDED|95.0|-0.24|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.05|-0.24|0.003
74087710|NCT00562120|147729516|SUPERIORITY_OR_OTHER|||||||0.229|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.229
74087711|NCT00562120|147729516|SUPERIORITY_OR_OTHER|||||||0.544|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.544
74087712|NCT00562120|147729516|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.710
74087713|NCT00562120|147729516|SUPERIORITY_OR_OTHER|||||||0.816|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.816
74087714|NCT00562120|147729517|SUPERIORITY_OR_OTHER|||||||0.269|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.269
74087715|NCT00562120|147729517|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.097
74029248|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|-0.25|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.06|-0.25|0.002
74029249|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.004|TWO_SIDED|95.0|-0.27|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.05|-0.27|0.004
74029250|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.003|TWO_SIDED|95.0|-0.28|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.06|-0.28|0.003
74029251|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.29|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.05|-0.29|0.006
73969387|NCT06429319|147478105|SUPERIORITY||LS-means difference|-37.64|STANDARD_ERROR_OF_MEAN|56.34||0.783|TWO_SIDED|95.0|-172.98|97.7||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||97.70|-172.98|0.783
73969388|NCT06429319|147478105|SUPERIORITY||LS-means difference|81.94|STANDARD_ERROR_OF_MEAN|60.45||0.37|TWO_SIDED|95.0|-63.28|227.16|||Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||227.16|-63.28|0.370
73969389|NCT06429319|147478105|SUPERIORITY||LS-means difference|119.58|STANDARD_ERROR_OF_MEAN|34.76||0.003|TWO_SIDED|95.0|36.09|203.07||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||203.07|36.09|0.003
73969390|NCT06429319|147478105|SUPERIORITY||F value|2.78||||0.07|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of one and two NOLTREX™ courses was used ANCOVA adjusted for the baseline value with fixed factor of treatment group."||The between-group comparison of changes from baseline (visit 1 study 1) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.070
73969391|NCT06429319|147478109|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"BASELINE (study 1 visit 1)~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.030
73969392|NCT06429319|147478109|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"BASELINE (OLE visit 0)~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.002
73969393|NCT06429319|147478109|SUPERIORITY|||||||0.007||||||The threshold for statistical significance was p \<0.05.|ANOVA|||"visit 3~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.007
73969394|NCT06429319|147478109|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"visit 5~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||<0.001
74087716|NCT00562120|147729517|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.252
74087717|NCT00562120|147729517|SUPERIORITY_OR_OTHER|||||||0.479|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.479
74087718|NCT00562120|147729517|SUPERIORITY_OR_OTHER|||||||0.521|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.521
74087719|NCT00562120|147729517|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.952
74087720|NCT00562120|147729518|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.130
74087721|NCT00562120|147729518|SUPERIORITY_OR_OTHER|||||||0.663|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.663
74087722|NCT00562120|147729518|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.138
74087723|NCT00562120|147729518|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.124
74087724|NCT00562120|147729518|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.134
74087725|NCT00562120|147729518|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.978
74087726|NCT00562120|147729519|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.357
74087727|NCT00562120|147729519|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.952
73926880|NCT00744627|147381447|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.267|<|0.001|TWO_SIDED|95.0|-7.61|-2.6||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-2.60|-7.61|<0.001
73926881|NCT00744627|147381448|SUPERIORITY_OR_OTHER||LS Mean Difference|8.78|STANDARD_ERROR_OF_MEAN|2.774||0.002|TWO_SIDED|95.0|3.32|14.25||SF-36 social functioning subscore was the last endpoint to be tested in the hierarchical testing sequence.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||Results presented are for the number of participants at week 8 only.||14.25|3.32|0.002
73926882|NCT01883427|147381486|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Not significant|Wilcoxon (Mann-Whitney)|||Too few included to reach power||||>0.05
73926883|NCT00502697|147381535|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The original proposed sample size for this study was 300. This sample size was based on previous evidence that indicated that a reduction of 15% in the rate of preterm birth would be detectable with groups of 150. Because of concerns with systemic changes in the study's health care delivery environment, an interim analysis was conducted after 200 women had delivered. As a result of that analysis a decision was made to stop recruitment.||||.64
73926884|NCT00589108|147381568|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 2 years post-surgery.||||0.64
73926885|NCT00589108|147381568|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 5 years post-surgery.||||0.80
73926886|NCT00589108|147381569|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||P-value for the difference for the Knee Society Function Score between the three groups at 5 years post-surgery.||||0.06
73926887|NCT00589108|147381570|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||P-value for the difference for the Knee Society Pain Score between the three groups at 5 years post-surgery.||||0.87
73926888|NCT00589108|147381571|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 2 years post-surgery.||||0.44
73926889|NCT00589108|147381571|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 5 years post-surgery.||||0.08
73926890|NCT00589108|147381572|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||P-value for the difference between the percentage of knees surviving between the three groups at 5 years post-surgery.||||0.92
73926891|NCT01713868|147381577|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was significant, we presented results from the interaction model.||||||0.03||||||Adjusted education effect p=0.34. Adjusted mHealth effect p\<0.001. Test for interaction p=0.01. Adjusted education only effect p=0.74. Adjusted mHealth only effect p=0.02. Adjusted mHealth and education effect: p=0.03|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction.We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||0.03
73926892|NCT01713868|147381578|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect: p=0.22. Adjusted mHealth effect p\<0.001. Test for interaction p=0.08.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up,this led to a sample of n=1600.||||<0.001
73926893|NCT01713868|147381579|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.07. Adjusted mHealth effect p\<0.001. Test for interaction p=0.54|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||<0.001
73969395|NCT06429319|147478110|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"Fisher's exact test was used to determine whether there is a significant difference between 3 groups.~visit 3"||||<0.001
73969396|NCT06429319|147478110|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||"visit 5~Fisher's exact test was used to determine whether there is a significant difference between 3 groups."||||<0.001
73969397|NCT06429319|147478111|SUPERIORITY|||||||0.018||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"visit 3~Fisher's exact test was used to determine whether there was a significant difference between 3 groups."||||0.018
73969398|NCT06429319|147478111|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"visit 5~Fisher's exact test was used to determine whether there was a significant difference between 3 groups."||||<0.001
73969399|NCT06429319|147478114|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution.||||0.010
73969400|NCT01369355|147478170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.040
73969401|NCT01369355|147478170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.005
73969402|NCT01369355|147478171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.033
73969403|NCT01369355|147478171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.018
73969404|NCT01369355|147478172|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.||||||0.189
74029252|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.004|TWO_SIDED|95.0|-0.29|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.06|-0.29|0.004
73969405|NCT01369355|147478172|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.||||||0.007
74029253|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.33|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.07|-0.33|0.003
74087728|NCT00562120|147729519|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.480
73969406|NCT01369355|147478173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.035
74087729|NCT00562120|147729519|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.043
73969407|NCT01369355|147478173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.004
73969408|NCT01369355|147478174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.||||||0.140
73969409|NCT01369355|147478174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.||||||0.102
73969410|NCT05349500|147478199|SUPERIORITY||Mean Difference (Final Values)|-11.0||||0.019|TWO_SIDED|95.0|-20.1|-1.9|||Mixed Models Analysis|||||-1.9|-20.1|0.019
74029254|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.13|-0.38|<0.001
74029255|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.11|-0.37|<0.001
74087730|NCT00562120|147729519|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.087
73862640|NCT01058941|147271179|OTHER||Mean Difference (Net)|-0.42||||0.82|TWO_SIDED|95.0|-3.97|3.13||We used a significance level of p = 0.025 for our measure of ADL changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.||3.13|-3.97|0.82
73969411|NCT05349500|147478200|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.286|TWO_SIDED|95.0|-14.1|4.3|||Mixed Models Analysis|||||4.3|-14.1|0.286
73969412|NCT05349500|147478201|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.046|TWO_SIDED|95.0|-4.0|0.0|||Mixed Models Analysis|||||-0.0|-4.0|0.046
73969413|NCT05349500|147478202|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.128|TWO_SIDED|95.0|-3.8|0.5|||Mixed Models Analysis|||||0.5|-3.8|0.128
73969414|NCT05349500|147478203|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.031|TWO_SIDED|95.0|-14.3|-0.7|||Mixed Models Analysis|||||-0.7|-14.3|0.031
73969415|NCT05349500|147478204|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.564|TWO_SIDED|95.0|-8.8|4.9|||Mixed Models Analysis|||||4.9|-8.8|0.564
74087731|NCT00562120|147729519|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.753
74087732|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.011
74087733|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.127
74087734|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.103
73969416|NCT05349500|147478205|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.349|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.349
74087735|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.218
74087736|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.905
74087737|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.273|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.273
74087738|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
74087739|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.055|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.055
74087740|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.012
74087741|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.048
74087742|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.496|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.496
74087743|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.190
74087744|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
74087745|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.019
74087746|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.009
74087747|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.061
74087748|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.778|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.778
74087749|NCT00562120|147729520|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.102
74087750|NCT00562120|147729521|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
73969417|NCT05349500|147478206|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.303|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||||0.2|-0.6|0.303
73969418|NCT05349500|147478207|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.507|TWO_SIDED|95.0|-0.1|0.2|||Mixed Models Analysis|||||0.2|-0.1|0.507
73969419|NCT05349500|147478208|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.729|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||||0.2|-0.2|0.729
73969420|NCT05349500|147478209|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.421|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||||0.1|-0.2|0.421
73969421|NCT05349500|147478210|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.648|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||||0.1|-0.2|0.648
73969422|NCT05349500|147478211|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.034|TWO_SIDED|95.0|0.3|6.5|||Mixed Models Analysis|||||6.5|0.3|0.034
73926894|NCT01713868|147381580|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.33. Adjusted mHealth effect p\<0.001. Test for interaction p=0.29.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||<0.001
73926895|NCT01713868|147381581|OTHER|Causal mediation analysis|Difference in proportions|0.16|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
73969423|NCT05349500|147478212|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.315|TWO_SIDED|95.0|-2.1|6.3|||Mixed Models Analysis|||||6.3|-2.1|0.315
74029256|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.39|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.13|-0.39|<0.001
74029257|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.15|-0.41|<0.001
74087751|NCT00562120|147729521|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
74087752|NCT00562120|147729521|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
73969424|NCT05349500|147478213|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.444|TWO_SIDED|95.0|-21.5|48.2|||Mixed Models Analysis|||||48.2|-21.5|0.444
73969425|NCT05349500|147478214|SUPERIORITY||Mean Difference (Final Values)|9.3||||0.638|TWO_SIDED|95.0|-30.6|49.2|||Mixed Models Analysis|||||49.2|-30.6|0.638
73969426|NCT05349500|147478215|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.688|TWO_SIDED|95.0|-13.4|8.9|||Mixed Models Analysis|||||8.9|-13.4|0.688
73969427|NCT05349500|147478216|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.709|TWO_SIDED|95.0|-2.5|1.7|||Mixed Models Analysis|||||1.7|-2.5|0.709
73969428|NCT05349500|147478217|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.089|TWO_SIDED|95.0|-3.3|0.2|||Mixed Models Analysis|||||0.2|-3.3|0.089
73969429|NCT05349500|147478218|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.066|TWO_SIDED|95.0|-1.0|30.8|||Mixed Models Analysis|||||30.8|-1.0|0.066
73969430|NCT01987895|147478227|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-1.4|||||TWO_SIDED|95.0|-7.2|4.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|||4.3|-7.2|
74087753|NCT00562120|147729521|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.217
74087754|NCT00562120|147729521|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.156
74087755|NCT00562120|147729521|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.848
74087756|NCT04184999|147729537|SUPERIORITY||F-Statistic|207.4|||<|0.01|TWO_SIDED||||||ANOVA|||||||<.01
74087757|NCT00545688|147729538|SUPERIORITY_OR_OTHER||Difference in Response rates|16.82||||0.0094|TWO_SIDED|95.0|3.5|30.1||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||30.1|3.5|0.0094
74087758|NCT00545688|147729538|SUPERIORITY_OR_OTHER|||||||0.0141|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0141
74087759|NCT00545688|147729538|SUPERIORITY_OR_OTHER||Difference in Response rates|-12.15||||0.0198|TWO_SIDED|95.0|-23.8|-0.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||-0.5|-23.8|0.0198
74087760|NCT00545688|147729538|SUPERIORITY_OR_OTHER|||||||0.0198|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0198
74087761|NCT00545688|147729538|SUPERIORITY_OR_OTHER||Difference in Response rates|-21.84||||0.001|TWO_SIDED|95.0|-35.1|-8.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||-8.5|-35.1|0.0010
73862641|NCT01058941|147271180|OTHER||Mean Difference (Net)|-3.68||||0.001|TWO_SIDED|95.0|-5.9|-1.46||We used a significance level of p = 0.025 for our measure of ADAS-cog changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.||-1.46|-5.90|0.001
73862642|NCT01274611|147271181|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|0.8|||<|0.01|||||||t-test, 2 sided|||||||<0.01
73862643|NCT01274611|147271182|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|15.0|||>|0.01|||||||t-test, 2 sided|||||||>0.01
73862644|NCT00897390|147271193|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.042|||||TWO_SIDED|90.0|1.009|1.075||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.075|1.009|
73862645|NCT00897390|147271193|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.988|||||TWO_SIDED|90.0|0.958|1.019||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.019|0.958|
73862646|NCT00897390|147271195|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.045|||||TWO_SIDED|90.0|1.013|1.077||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.077|1.013|
73862647|NCT00897390|147271195|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.992|||||TWO_SIDED|90.0|0.962|1.022||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.022|0.962|
73926896|NCT01713868|147381582|OTHER|Causal mediation analysis|Difference in proportions|0.14|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
73926897|NCT01713868|147381583|OTHER|Causal mediation analysis|Difference in proportions|0.14|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
74029258|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.11|-0.37|<0.001
74029259|NCT04003155|147612901|SUPERIORITY||MMRM|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.12|-0.41|<0.001
74087762|NCT00545688|147729538|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0030
73926898|NCT01713868|147381584|OTHER|Causal mediation analysis|Difference in proportions|0.15|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
73926899|NCT03026257|147381585|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
73926900|NCT03026257|147381585|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
73969431|NCT01987895|147478227|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-2.4|||||TWO_SIDED|95.0|-8.1|3.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT||3.2|-8.1|
74087763|NCT00545688|147729553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.2983|TWO_SIDED|95.0|0.34|1.4|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||1.40|0.34|0.2983
73969432|NCT01987895|147478228|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-4.1|||||TWO_SIDED|95.0|-9.2|1.0|||||CI for the difference between two proportions are estimated using the Wilson' score method|||1.0|-9.2|
73969433|NCT01987895|147478229|SUPERIORITY|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|3.3|||||TWO_SIDED|95.0|-4.3|10.8|||||CI for the difference between two proportions are estimated using the Wilson's score method|||10.8|-4.3|
73969434|NCT01987895|147478230|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.6016|TWO_SIDED|95.0|0.8|1.14||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank|||||1.14|0.80|0.6016
73969435|NCT01987895|147478231|SUPERIORITY||Least Square Mean difference|0.002||||0.9814|TWO_SIDED|95.0|-0.2|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores||0.20|-0.20|0.9814
73969436|NCT01987895|147478231|SUPERIORITY||Least Square Mean difference|0.087||||0.2879|TWO_SIDED|95.0|-0.07|0.25||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores||0.25|-0.07|0.2879
73969437|NCT01987895|147478231|SUPERIORITY||Least Square Mean difference|0.05||||0.488|TWO_SIDED|95.0|-0.09|0.19||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the systemic / other symptoms domain scores||0.19|-0.09|0.4880
73969438|NCT01987895|147478232|OTHER||Difference between 2 proportions|-1.8|||||TWO_SIDED|95.0|-6.5|2.9|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||2.9|-6.5|
73969439|NCT01987895|147478233|OTHER||Difference between 2 proportions|-1.9|||||TWO_SIDED|95.0|-6.2|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||2.3|-6.2|
73969440|NCT01987895|147478234|OTHER||Difference between 2 proportions|3.7|||||TWO_SIDED|95.0|-3.4|10.7|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||10.7|-3.4|
73969441|NCT01987895|147478235|OTHER|Sensitivity analysis|Difference between 2 proportions|1.1|||||TWO_SIDED|95.0|-6.5|8.7|||||CI for the difference between two proportions are estimated using the Wilson's score method|||8.7|-6.5|
73969442|NCT05364671|147478237|SUPERIORITY|||||||0.0088||||||A priori threshold for statistical significance is set to 0.04|Chi-squared|||||||0.0088
74087764|NCT00545688|147729553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.4722|TWO_SIDED|95.0|0.68|2.3|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||2.30|0.68|0.4722
74087765|NCT00545688|147729553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.05||||0.0268|TWO_SIDED|95.0|1.07|3.93|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||3.93|1.07|0.0268
74087766|NCT00545688|147729553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1805|TWO_SIDED|95.0|0.28|1.27|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||1.27|0.28|0.1805
73926901|NCT03026257|147381585|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
73926902|NCT03026257|147381585|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
73926903|NCT03026257|147381585|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
73969443|NCT05364671|147478238|SUPERIORITY|||||||0.0025||||||A priori threshold for statistical significance is set to 0.005|Wilcoxon (Mann-Whitney)|||Mean differences (Raphamin vs. Placebo) were compared||||0.0025
73926904|NCT03026257|147381585|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
73926905|NCT03026257|147381585|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
73926906|NCT03026257|147381585|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
73926907|NCT05228470|147381612|OTHER|Null hypothesis of ORR by BICR was 30%.||||||0.0076|||||||Exact binomial test|||||||0.0076
73969444|NCT05364671|147478240|SUPERIORITY|||||||0.2607|||||||Wilcoxon (Mann-Whitney)|||Mean differences (Raphamin vs. Placebo) were compared||||0.2607
73969445|NCT05364671|147478241|SUPERIORITY|||||||0.7601|||||||Fisher Exact|||"This analysis applies to Day 6 row."||||0.7601
73969446|NCT05364671|147478241|SUPERIORITY|||||||0.7685|||||||Fisher Exact|||"This analysis applies to Day 10 row."||||0.7685
73969447|NCT05364671|147478242|SUPERIORITY|||||||0.052|||||||Fisher Exact|||||||0.052
73969448|NCT05364671|147478243|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
73862648|NCT00897390|147271196|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.077|||||TWO_SIDED|90.0|0.978|1.185||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.185|0.978|
74087767|NCT00545688|147729553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.5901|TWO_SIDED|95.0|0.42|1.64|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||1.64|0.42|0.5901
73926908|NCT05620576|147381638|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.61|0.82|||||Posterior mean difference with 95% credible interval is reported.|||0.82|-0.61|
73926909|NCT05620576|147381639|SUPERIORITY||Posterior Mean Difference|0.26|||||TWO_SIDED|95.0|-0.47|0.99|||||Posterior mean difference with 95% credible interval is reported.|||0.99|-0.47|
73926910|NCT05620576|147381640|SUPERIORITY||Posterior Mean Difference|0.33|||||TWO_SIDED|95.0|-0.11|0.78|||||Posterior mean difference with 95% credible interval is reported.|||0.78|-0.11|
74087768|NCT00545688|147729553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.16||||0.025|TWO_SIDED|95.0|1.08|4.32|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||4.32|1.08|0.0250
74087769|NCT02953678|147729573|OTHER||Exact method for binomial distributions|54.9|||||TWO_SIDED|95.0|42.7|66.8||||||||66.8|42.7|
74087770|NCT01730040|147729598|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.1|||<|0.0001|TWO_SIDED|99.0|-55.9|-22.2|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-22.2|-55.9|< 0.0001
74087771|NCT01730040|147729598|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.6|||=|0.0004|TWO_SIDED|99.0|-40.7|-6.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||-6.5|-40.7|= 0.0004
74087772|NCT01730040|147729598|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.2|||<|0.0001|TWO_SIDED|99.0|-65.0|-33.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-33.5|-65|< 0.0001
74087773|NCT01730040|147729598|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.6|||<|0.0001|TWO_SIDED|99.0|-48.4|-16.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.9|-48.4|< 0.0001
74087774|NCT01730040|147729598|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|99.0|-47.4|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.4|-47.4|<0.0001
74087775|NCT01730040|147729599|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.5|||<|0.0001|TWO_SIDED|99.0|-59.2|-25.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1% level.||-25.7|-59.2|< 0.0001
74087776|NCT01730040|147729599|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.9|||=|0.0002|TWO_SIDED|99.0|-41.9|-7.8||Threshold for significance≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.8|-41.9|= 0.0002
74087777|NCT01730040|147729599|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.8|||<|0.0001|TWO_SIDED|99.0|-69.2|-36.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-36.5|-69.2|< 0.0001
74087778|NCT01730040|147729599|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|||<|0.0001|TWO_SIDED|99.0|-51.3|-18.6|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Analysis description as per the statistical analysis 1 of this endpoint.||-18.6|-51.3|< 0.0001
74087779|NCT01730040|147729599|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.4|||<|0.0001|TWO_SIDED|99.0|-50.0|-16.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.8|-50.0|< 0.0001
74087780|NCT01730040|147729600|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.8|||<|0.0001|TWO_SIDED|99.0|-54.0|-25.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.6|-54|<0.0001
74087781|NCT01730040|147729600|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|99.0|-40.0|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-40.0|<0.0001
74087782|NCT01730040|147729600|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.0|||<|0.0001|TWO_SIDED|99.0|-47.7|-24.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-24.3|-47.7|<0.0001
74087783|NCT01730040|147729600|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|99.0|-39.2|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.4|-39.2|<0.0001
74087784|NCT01730040|147729600|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.9|||<|0.0001|TWO_SIDED|99.0|-32.8|-8.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.9|-32.8|<0.0001
74087785|NCT01730040|147729601|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.5|||<|0.0001|TWO_SIDED|99.0|-55.8|-33.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-33.1|-55.8|<0.0001
74087786|NCT01730040|147729601|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.6|||<|0.0001|TWO_SIDED|99.0|-38.0|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.2|-38.0|<0.0001
73926911|NCT05620576|147381641|SUPERIORITY||Posterior Mean Difference|0.2|||||TWO_SIDED|95.0|-0.56|0.96|||||Posterior mean difference with 95% credible interval is reported.|||0.96|-0.56|
73926912|NCT05620576|147381642|SUPERIORITY||Posterior Mean Difference|-0.77|||||TWO_SIDED|95.0|-9.41|7.75|||||Posterior mean difference with 95% credible interval is reported.|||7.75|-9.41|
73926913|NCT05620576|147381643|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.51|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.51|
73926914|NCT05620576|147381644|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.11|
73926915|NCT05620576|147381645|SUPERIORITY||Posterior Mean Difference|23.02|||||TWO_SIDED|95.0|-108.05|152.33|||||Posterior mean difference with 95% credible interval is reported.|||152.33|-108.05|
73926916|NCT01921829|147381674|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
74029260|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.35|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.06|-0.35|0.004
73926917|NCT01921829|147381675|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
73926918|NCT01921829|147381677|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
73926919|NCT01921829|147381678|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
73926920|NCT01921829|147381679|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
73926921|NCT01921829|147381680|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
73926922|NCT01921829|147381681|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
73926923|NCT01921829|147381682|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
73926924|NCT01921829|147381683|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
73926925|NCT01921829|147381684|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
73926926|NCT01921829|147381685|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
73926927|NCT01921829|147381686|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
73926928|NCT01921829|147381687|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
73926929|NCT01921829|147381688|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
73926930|NCT01921829|147381689|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
73926931|NCT01921829|147381690|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
73926932|NCT01921829|147381691|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
73926933|NCT01921829|147381692|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
73926934|NCT01921829|147381693|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
73926935|NCT01921829|147381694|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
73926936|NCT04476030|147381695|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.55||0.0004|TWO_SIDED|95.0|-3.0|-0.9|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||-0.9|-3.0|0.0004
73926937|NCT04476030|147381696|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.56||0.0054|TWO_SIDED|95.0|-2.7|-0.5|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||-0.5|-2.7|0.0054
73926938|NCT04476030|147381697|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.7||0.2477|TWO_SIDED|95.0|-2.2|0.6|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|Day 15||0.6|-2.2|0.2477
73926939|NCT04476030|147381697|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.79||0.9248|TWO_SIDED|95.0|-1.6|1.5|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|Day 42||1.5|-1.6|0.9248
73926940|NCT04476030|147381698|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.65||0.4458|TWO_SIDED|95.0|-1.8|0.8|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.8|-1.8|0.4458
74029261|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.13|-0.43|<0.001
73926941|NCT04476030|147381699|SUPERIORITY||Odds Ratio (OR)|1.15||||0.4946|TWO_SIDED|95.0|0.78|1.69|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15|Generalized estimating equation is abbreviated as GEE in the method of estimation section.|1.69|0.78|0.4946
73926942|NCT04476030|147381699|SUPERIORITY||Odds Ratio (OR)|0.82||||0.3579|TWO_SIDED|95.0|0.55|1.24|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 42||1.24|0.55|0.3579
73926943|NCT04476030|147381700|SUPERIORITY||Odds Ratio (OR)|1.41||||0.1417|TWO_SIDED|95.0|0.89|2.24|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15||2.24|0.89|0.1417
73926944|NCT04476030|147381700|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7872|TWO_SIDED|95.0|0.62|1.44|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 42||1.44|0.62|0.7872
73926945|NCT04476030|147381701|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1993|TWO_SIDED|95.0|-0.4|0.1|||MMRM||Model used was the MMRM with treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.1|-0.4|0.1993
73926946|NCT04476030|147381702|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0079|TWO_SIDED|95.0|1.21|3.47|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 3||3.47|1.21|0.0079
73926947|NCT04476030|147381702|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6588|TWO_SIDED|95.0|0.74|1.62|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15||1.62|0.74|0.6588
73862649|NCT00897390|147271196|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.987|||||TWO_SIDED|90.0|0.9|1.083||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.083|0.900|
73862650|NCT00897390|147271199|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974|||||TWO_SIDED|90.0|0.921|1.03||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.030|0.921|
73862651|NCT00897390|147271199|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.966||||||90.0|0.915|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.020|0.915|
73969449|NCT05364671|147478244|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
73969450|NCT05364671|147478245|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.10
73969451|NCT05364671|147478246|SUPERIORITY|||||||0.92||||||"The p-value associated with treatment\*visit interaction of pulse rate (heart rate) from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.92
74029262|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.37|-0.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.08|-0.37|0.002
74029263|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.12|-0.43|<0.001
74087787|NCT01730040|147729601|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.3|||<|0.0001|TWO_SIDED|99.0|-48.1|-24.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-24.5|-48.1|<0.0001
74087788|NCT01730040|147729601|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.7|||<|0.0001|TWO_SIDED|99.0|-39.6|-15.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.8|-39.6|<0.0001
74087789|NCT01730040|147729601|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.2|||<|0.0001|TWO_SIDED|99.0|-32.2|-8.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.2|-32.2|<0.0001
74087790|NCT01730040|147729602|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|99.0|-42.0|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-16.6|-42.0|<0.0001
74087791|NCT01730040|147729602|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.6|||<|0.0001|TWO_SIDED|99.0|-36.6|-10.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-10.7|-36.6|<0.0001
74087792|NCT01730040|147729602|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.4|||<|0.0001|TWO_SIDED|99.0|-50.8|-26.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-26.0|-50.8|<0.0001
74087793|NCT01730040|147729602|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.9|||<|0.0001|TWO_SIDED|99.0|-43.2|-18.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.6|-43.2|<0.0001
73969452|NCT05364671|147478247|SUPERIORITY|||||||0.44||||||"The p-value associated with treatment\*visit interaction of respiration rate (breathing rate) from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.44
73969453|NCT05364671|147478248|SUPERIORITY|||||||0.9||||||"The p-value associated with treatment\*visit interaction of SpO2 from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.90
73969454|NCT05364671|147478249|SUPERIORITY|||||||0.3||||||"The p-value associated with treatment\*visit interaction of SBP from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.30
73969455|NCT05364671|147478249|SUPERIORITY|||||||0.94||||||"The p-value associated with treatment\*visit interaction of DBP from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.94
73862652|NCT00897390|147271200|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.962||||||90.0|0.906|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.020|0.906|
73969456|NCT02359890|147478251|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with events|2.6|||||TWO_SIDED|95.0|0.7|6.5|||||The 2-sided 95% confidence interval is derived using the exact Clopper-Pearson interval.|||6.5|0.7|
73969457|NCT02359890|147478253|SUPERIORITY_OR_OTHER_LEGACY||Percentage of patient with acute success|96.2|||||TWO_SIDED|95.0|92.0|98.6|||||The 2-sided 95% confidence interval is derived using the exact Clopper-Pearson interval|||98.6|92.0|
73969458|NCT05256017|147478255|OTHER||Excess rate (ER)|-1.5|||||TWO_SIDED|95.0|-7.2|3.7||||||||3.7|-7.2|
73969459|NCT05256017|147478256|OTHER||Excess rate (ER)|-0.9|||||TWO_SIDED|95.0|-4.1|1.4|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|Occurrence and excess rate (95% CI) of any TEAEs (by PT, for PTs reported in ≥1% of participants in either arm) from the investigational product administration (Day 1) to the Month 4 follow-up visit.||1.4|-4.1|
73926948|NCT04476030|147381703|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.06||0.2322|TWO_SIDED|95.0|-3.4|0.8|||MMRM||Model used was the MMRM with treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.8|-3.4|0.2322
73926949|NCT04476030|147381704|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5439|TWO_SIDED|95.0|0.76|1.68|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|||1.68|0.76|0.5439
73926950|NCT04476030|147381705|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7054|TWO_SIDED|95.0|0.7|1.69|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|||1.69|0.70|0.7054
73926951|NCT04476030|147381706|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62||0.4188|TWO_SIDED|95.0|-1.7|0.7|||MMRM||Model used was the MMRM with treatment, baseline HAM-A total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.7|-1.7|0.4188
73926952|NCT04476030|147381708|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7758|TWO_SIDED|95.0|-1.4|1.0|||MMRM||Model used was the MMRM with treatment, baseline PHQ-9 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||1.0|-1.4|0.7758
73926953|NCT05394025|147381714|SUPERIORITY||Interaction|0.02||||0.77|TWO_SIDED|95.0|-0.13|0.18|||likelihood ratio test||Beta for time by COVID-19 status|Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.||0.18|-0.13|0.77
73969460|NCT05256017|147478257|OTHER||Excess rate (ER)|0.4|||||TWO_SIDED|95.0|-1.6|1.6|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.6|-1.6|
73969461|NCT05256017|147478258|OTHER||Excess rate (ER)|-0.5|||||TWO_SIDED|95.0|-3.2|1.4|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.4|-3.2|
73969462|NCT05256017|147478259|OTHER||Excess rate (ER)|-0.6|||||TWO_SIDED|95.0|-2.6|0.6|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.6|-2.6|
74029264|NCT04003155|147612901|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.4|-0.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.09|-0.40|0.002
73969463|NCT05256017|147478260|OTHER||Excess rate (ER)|-0.2|||||TWO_SIDED|95.0|-2.2|0.8|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.8|-2.2|
73969464|NCT05256017|147478261|OTHER||Excess rate (ER)|-0.3|||||TWO_SIDED|95.0|-2.3|0.7|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.7|-2.3|
73926954|NCT05394025|147381714|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.6|TWO_SIDED|95.0|-0.44|0.67|||likelihood ratio test||Beta coefficient for mean difference in mean longitudinal I/ADL score|Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model I/ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.||0.67|-0.44|0.60
73926955|NCT01536496|147381715|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Chi-squared|||Chi-square test||||0.04
74029265|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-15.52|STANDARD_ERROR_OF_MEAN|3.29|<|0.001|TWO_SIDED|95.0|-21.99|-9.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-9.06|-21.99|<0.001
74029266|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-12.22|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-18.69|-5.74||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-5.74|-18.69|<0.001
74029267|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-17.3|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-24.32|-10.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-10.27|-24.32|<0.001
74029268|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-18.29|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-25.3|-11.29||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-11.29|-25.30|<0.001
74029269|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-18.13|STANDARD_ERROR_OF_MEAN|3.63|<|0.001|TWO_SIDED|95.0|-25.25|-11.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-11.00|-25.25|<0.001
74029270|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-21.19|STANDARD_ERROR_OF_MEAN|3.61|<|0.001|TWO_SIDED|95.0|-28.29|-14.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-14.09|-28.29|<0.001
74029271|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-16.75|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-24.24|-9.26||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-9.26|-24.24|<0.001
74029272|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-21.05|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-28.5|-13.61||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-13.61|-28.50|<0.001
74029273|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-17.57|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-25.02|-10.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-10.12|-25.02|<0.001
74029274|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-21.78|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-29.18|-14.39||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-14.39|-29.18|<0.001
74029275|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-18.39|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-26.03|-10.75||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-10.75|-26.03|<0.001
74029276|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-23.83|STANDARD_ERROR_OF_MEAN|3.85|<|0.001|TWO_SIDED|95.0|-31.39|-16.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-16.27|-31.39|<0.001
74029277|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-18.29|STANDARD_ERROR_OF_MEAN|4.09|<|0.001|TWO_SIDED|95.0|-26.33|-10.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-10.25|-26.33|<0.001
74087794|NCT01730040|147729602|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.6|||<|0.0001|TWO_SIDED|99.0|-40.1|-15.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.1|-40.1|<0.0001
74087795|NCT01730040|147729603|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.6|||<|0.0001|TWO_SIDED|99.0|-44.6|-20.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.6|-44.6|<0.0001
74087796|NCT01730040|147729603|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|99.0|-37.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.8|-37.3|<0.0001
73926956|NCT01344447|147381740|SUPERIORITY_OR_OTHER||Percentage difference|22.3|||<|0.0001|TWO_SIDED|95.1|20.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||20.4|<0.0001
74029278|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-21.41|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-29.35|-13.48||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-13.48|-29.35|<0.001
73926957|NCT01344447|147381740|SUPERIORITY_OR_OTHER||Percentage difference|63.8|||<|0.0001|TWO_SIDED|95.1|60.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||60.9|<0.0001
73926958|NCT01344447|147381740|SUPERIORITY_OR_OTHER||Percentage difference|19.6|||<|0.0001|TWO_SIDED|95.1|17.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||17.8|<0.0001
73926959|NCT01344447|147381740|SUPERIORITY_OR_OTHER||Percentage difference|15.0|||<|0.0001|TWO_SIDED|95.1|13.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||13.3|<0.0001
73926960|NCT01344447|147381740|SUPERIORITY_OR_OTHER||Percentage difference|18.5|||<|0.0001|TWO_SIDED|95.1|16.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||16.5|<0.0001
74029279|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-20.16|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.14|-12.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-12.19|-28.14|<0.001
74087797|NCT01730040|147729603|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.3|||<|0.0001|TWO_SIDED|99.0|-51.2|-25.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-25.4|-51.2|<0.0001
74087798|NCT01730040|147729603|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|99.0|-42.6|-17.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.1|-42.6|<0.0001
74087799|NCT01730040|147729603|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.4|||<|0.0001|TWO_SIDED|99.0|-39.4|-13.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-13.4|-39.4|<0.0001
74087800|NCT01730040|147729604|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.4|||<|0.0001|TWO_SIDED|99.0|-44.7|-16.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-16.1|-44.7|<0.0001
74087801|NCT01730040|147729604|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.6|||=|0.0002|TWO_SIDED|99.0|-36.1|-7.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.1|-36.1|=0.0002
74087802|NCT01730040|147729604|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.1|||<|0.0001|TWO_SIDED|99.0|-54.7|-27.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-27.5|-54.7|<0.0001
74087803|NCT01730040|147729604|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.2|||<|0.0001|TWO_SIDED|99.0|-43.7|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.6|-43.7|<0.0001
74087804|NCT01730040|147729604|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.6|||<|0.0001|TWO_SIDED|99.0|-40.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.8|-40.3|<0.0001
74087805|NCT01730040|147729605|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.0|||<|0.0001|TWO_SIDED|99.0|-47.0|-19.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-19.0|-47.0|<0.0001
74087806|NCT01730040|147729605|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|99.0|-36.6|-8.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.1|-36.6|<0.0001
74087807|NCT01730040|147729605|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.6|||<|0.0001|TWO_SIDED|99.0|-57.4|-29.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-29.7|-57.4|<0.0001
74087808|NCT01730040|147729605|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.1|||<|0.0001|TWO_SIDED|99.0|-46.0|-18.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.3|-46.0|<0.0001
74087809|NCT01730040|147729605|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|99.0|-41.4|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-13.2|-41.4|<0.0001
74087810|NCT01730040|147729606|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.1|||<|0.0001|TWO_SIDED|99.0|-32.9|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-13.2|-32.9|<0.0001
74087811|NCT01730040|147729606|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|99.0|-25.8|-5.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-5.8|-25.8|<0.0001
74087812|NCT01730040|147729606|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.9|||<|0.0001|TWO_SIDED|99.0|-39.4|-18.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.4|-39.4|<0.0001
73969465|NCT05256017|147478262|OTHER||Excess rate (ER)|3.2|||||TWO_SIDED|95.0|0.3|5.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||5.3|0.3|
73969466|NCT05256017|147478263|OTHER||Excess rate (ER)|-0.1|||||TWO_SIDED|95.0|-2.4|1.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.3|-2.4|
73969467|NCT05256017|147478264|OTHER||Excess rate (ER)|-1.1|||||TWO_SIDED|95.0|-3.5|0.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.3|-3.5|
73969468|NCT05256017|147478265|OTHER||Excess rate (ER)|1.0|||||TWO_SIDED|95.0|-3.7|5.1||||||Occurrence and excess rate (95% CI) of any TEAEs reported during hospitalization.||5.1|-3.7|
73969469|NCT05256017|147478265|OTHER||Excess rate (ER)|-3.3|||||TWO_SIDED|95.0|-8.2|0.9||||||Occurrence and excess rate (95% CI) of any TEAEs reported after the hospitalization period.||0.9|-8.2|
73926961|NCT01344447|147381741|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.7|||||TWO_SIDED|95.1|-3.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-3.6|
73926962|NCT01344447|147381741|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||TWO_SIDED|95.1|-5.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.4|
73926963|NCT01344447|147381741|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||TWO_SIDED|95.1|-4.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-4.7|
73926964|NCT01344447|147381741|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|3.2|||||TWO_SIDED|95.1|-5.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.9|
73926965|NCT01344447|147381741|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|21.5|||||TWO_SIDED|95.1|14.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||14.1|
73926966|NCT01344447|147381742|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|8.8|||||TWO_SIDED|95.1|7.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.7|
73926967|NCT01344447|147381742|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|30.3|||||TWO_SIDED|95.1|28.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||28.6|
73926968|NCT01344447|147381742|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||TWO_SIDED|95.1|8.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||8.5|
73926969|NCT01344447|147381742|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|7.6|||||TWO_SIDED|95.1|6.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||6.6|
73926970|NCT01344447|147381742|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.1|||||TWO_SIDED|95.1|7.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.9|
74087813|NCT01730040|147729606|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.9|||<|0.0001|TWO_SIDED|99.0|-32.4|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.4|-32.4|<0.0001
73926971|NCT01344447|147381743|SUPERIORITY_OR_OTHER||percentage|61.7|||||ONE_SIDED|95.1|55.3||||One sided 95.1% confidence interval|||Majority reader|||55.3|
74087814|NCT01730040|147729606|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.4|||<|0.0001|TWO_SIDED|99.0|-29.1|-7.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.7|-29.1|<0.0001
73926972|NCT01344447|147381743|SUPERIORITY_OR_OTHER||percentage|60.3|||||ONE_SIDED|95.1|53.6||||One sided 95.1% confidence interval|||Blinded Reader 1|||53.6|
73926973|NCT01344447|147381743|SUPERIORITY_OR_OTHER||percentage|59.6|||||ONE_SIDED|95.1|53.1||||One sided 95.1% confidence interval|||Blinded Reader 2|||53.1|
73926974|NCT01344447|147381743|SUPERIORITY_OR_OTHER||percentage|58.7|||||ONE_SIDED|95.1|52.2||||One sided 95.1% confidence interval|||Blinded Reader 3|||52.2|
73969470|NCT05256017|147478266|OTHER||Excess rate (ER)|-1.0|||||TWO_SIDED|95.0|-3.1|0.0||||||||0.0|-3.1|
73969471|NCT05256017|147478267|OTHER||Excess rate (ER)|-1.5|||||TWO_SIDED|95.0|-7.2|3.7||||||Of note, all AEs reported during this study were TEAEs.||3.7|-7.2|
73969472|NCT05256017|147478285|OTHER||Placebo-corrected change from baseline|-0.4|||||TWO_SIDED|90.0|-2.1|1.4||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||1.4|-2.1|
73969473|NCT05256017|147478286|OTHER||Placebo-corrected change from baseline|-0.5|||||TWO_SIDED|90.0|-22.0|21.1||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||21.1|-22.0|
74087815|NCT01730040|147729607|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.5|||<|0.0001|TWO_SIDED|99.0|-41.6|-21.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.3|-41.6|<0.0001
74087816|NCT01730040|147729607|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.3|||<|0.0001|TWO_SIDED|99.0|-35.4|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.2|-35.4|<0.0001
74087817|NCT01730040|147729607|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.7|||<|0.0001|TWO_SIDED|99.0|-35.9|-17.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.5|-35.9|<0.0001
74087818|NCT01730040|147729607|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.2|||<|0.0001|TWO_SIDED|99.0|-31.5|-12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.9|-31.5|<0.0001
74087819|NCT01730040|147729607|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.9|||<|0.0001|TWO_SIDED|99.0|-25.2|-6.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-6.6|-25.2|<0.0001
74087820|NCT01730040|147729608|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.5|||<|0.0001|TWO_SIDED|99.0|-45.3|-21.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.6|-45.3|<0.0001
74087821|NCT01730040|147729608|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.4|||<|0.0001|TWO_SIDED|99.0|-35.2|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-35.2|<0.0001
74087822|NCT01730040|147729608|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|99.0|-39.0|-19.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-19.6|-39.0|<0.0001
74087823|NCT01730040|147729608|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|99.0|-32.3|-12.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.7|-32.3|<0.0001
74087824|NCT01730040|147729608|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.8|||<|0.0001|TWO_SIDED|99.0|-24.7|-4.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-4.9|-24.7|<0.0001
74087825|NCT01730040|147729609|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.6|||<|0.0001|TWO_SIDED|99.0|-31.4|-13.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-13.8|-31.4|<0.0001
74087826|NCT01730040|147729609|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|99.0|-24.6|-7.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.0|-24.6|<0.0001
74087827|NCT01730040|147729609|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.1|||<|0.0001|TWO_SIDED|99.0|-26.9|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.4|-26.9|<0.0001
74087828|NCT01730040|147729609|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.4|||<|0.0001|TWO_SIDED|99.0|-23.3|-7.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.6|-23.3|<0.0001
74087829|NCT01730040|147729609|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.8|||=|0.0015|TWO_SIDED|99.0|-17.7|-1.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-1.9|-17.7|=0.0015
74087830|NCT01730040|147729610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.7|||<|0.0001|TWO_SIDED|99.0|3.9|71.7||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||71.7|3.9|<0.0001
73926975|NCT01344447|147381743|SUPERIORITY_OR_OTHER||percentage|61.5|||||ONE_SIDED|95.1|56.7||||One sided 95.1% confidence interval|||Clinical investigator|||56.7|
73926976|NCT01344447|147381744|SUPERIORITY_OR_OTHER||percentage|98.0|||||ONE_SIDED|95.1|97.7||||One sided 95.1% confidence interval|||Majority reader|||97.7|
73926977|NCT01344447|147381744|SUPERIORITY_OR_OTHER||percentage|97.6|||||ONE_SIDED|95.1|97.3||||One sided 95.1% confidence interval|||Blinded Reader 1|||97.3|
73926978|NCT01344447|147381744|SUPERIORITY_OR_OTHER||percentage|97.2|||||ONE_SIDED|95.1|96.9||||One sided 95.1% confidence interval|||Blinded Reader 2|||96.9|
73926979|NCT01344447|147381744|SUPERIORITY_OR_OTHER||percentage|98.0|||||ONE_SIDED|95.1|97.7||||One sided 95.1% confidence interval|||Blinded Reader 3|||97.7|
73926980|NCT01344447|147381744|SUPERIORITY_OR_OTHER||percentage|99.2|||||ONE_SIDED|95.1|98.9||||One sided 95.1% confidence interval|||Clinical investigator|||98.9|
74087831|NCT01730040|147729610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||=|0.0284|TWO_SIDED|99.0|0.8|14.6||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||14.6|0.8|=0.0284
73926981|NCT01344447|147381745|SUPERIORITY_OR_OTHER||Diameter difference|0.21|STANDARD_DEVIATION|0.8|||||||||Mean Difference|||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point||||
73926982|NCT01344447|147381745|SUPERIORITY_OR_OTHER||Diameter difference|0.0|STANDARD_DEVIATION|0.79|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point||||
73926983|NCT01344447|147381745|SUPERIORITY_OR_OTHER||Diameter difference|0.29|STANDARD_DEVIATION|0.87|||||||||Mean Difference|||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point||||
73926984|NCT01344447|147381745|SUPERIORITY_OR_OTHER||Diameter difference|0.01|STANDARD_DEVIATION|0.8|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point||||
73926985|NCT01344447|147381745|SUPERIORITY_OR_OTHER||Diameter difference|0.48|STANDARD_DEVIATION|0.98|||||||||Mean Difference|||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at normal point||||
73926986|NCT01344447|147381745|SUPERIORITY_OR_OTHER||Diameter difference|0.33|STANDARD_DEVIATION|1.01|||||||||Mean Difference|||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at normal point||||
73926987|NCT01344447|147381745|SUPERIORITY_OR_OTHER||Diameter difference|0.02|STANDARD_DEVIATION|0.81|||||||||Mean Difference|||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at narrowest point||||
73926988|NCT01344447|147381745|SUPERIORITY_OR_OTHER||Diameter difference|0.11|STANDARD_DEVIATION|0.79|||||||||Mean Difference|||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at narrowest point||||
73926989|NCT03249779|147381764|SUPERIORITY|||||||0.0396|||||||t-test, 2 sided|||||||0.0396
73926990|NCT03249779|147381765|SUPERIORITY|||||||0.133|||||||t-test, 2 sided|||||||0.1330
73926991|NCT02932904|147381793|SUPERIORITY||Least square (LS) Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|1.04||0.009|TWO_SIDED|95.0|0.69|4.78||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA with last observation carried forward (LOCF) model was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||4.78|0.69|0.009
73926992|NCT02932904|147381793|SUPERIORITY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.017||0.303|TWO_SIDED|95.0|-0.95|3.05||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.05|-0.95|0.303
73926993|NCT02932904|147381794|SUPERIORITY||LS Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.627||0.072|TWO_SIDED|95.0|-0.1|2.37|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.37|-0.10|0.072
74087832|NCT01730040|147729610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|83.2|||<|0.0001|TWO_SIDED|99.0|11.6|596.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||596.8|11.6|<0.0001
74087833|NCT01730040|147729610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.2|||=|0.0025|TWO_SIDED|99.0|1.3|38.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||38.3|1.3|=0.0025
74087834|NCT01730040|147729610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.1|||=|0.0011|TWO_SIDED|99.0|1.6|52.2||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||52.2|1.6|=0.0011
74087835|NCT01730040|147729611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|128.4|||<|0.0001|TWO_SIDED|99.0|14.2|1157.0||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1157|14.2|<0.0001
74087836|NCT01730040|147729611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.9|||=|0.0015|TWO_SIDED|99.0|1.6|75.4||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||75.4|1.6|=0.0015
74087837|NCT01730040|147729611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.7|||=|0.0008|TWO_SIDED|99.0|1.8|101.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||101.1|1.8|=0.0008
74087838|NCT01730040|147729612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|116.8|||<|0.0001|TWO_SIDED|99.0|14.7|927.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||927.5|14.7|<0.0001
74087839|NCT01730040|147729612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.2|||<|0.0001|TWO_SIDED|99.0|2.5|68.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||68.8|2.5|<0.0001
74087840|NCT01730040|147729612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.9|||=|0.0004|TWO_SIDED|99.0|1.9|51.9||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||51.9|1.9|=0.0004
74087841|NCT01730040|147729613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|162.1|||<|0.0001|TWO_SIDED|99.0|17.3|1520.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1520.5|17.3|<0.0001
74087842|NCT01730040|147729613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.8|||<|0.0001|TWO_SIDED|99.0|3.1|126.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||126.3|3.1|<0.0001
74087843|NCT01730040|147729613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.9|||=|0.0002|TWO_SIDED|99.0|2.2|88.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||88.1|2.2|=0.0002
73926994|NCT02932904|147381794|SUPERIORITY||LS Mean Difference|1.29|STANDARD_ERROR_OF_MEAN|0.612||0.035|TWO_SIDED|95.0|0.09|2.5|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.50|0.09|0.035
73926995|NCT02932904|147381794|SUPERIORITY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.846||0.149|TWO_SIDED|95.0|-0.44|2.89|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.89|-0.44|0.149
73926996|NCT02932904|147381794|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.828||0.303|TWO_SIDED|95.0|-0.78|2.48|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.48|-0.78|0.303
73926997|NCT02932904|147381794|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.906||0.028|TWO_SIDED|95.0|0.22|3.78|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.78|0.22|0.028
73969474|NCT05256017|147478287|OTHER||Placebo-corrected change from baseline|-1.1|||||TWO_SIDED|90.0|-3.6|1.3||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||1.3|-3.6|
73969475|NCT05256017|147478288|OTHER||Placebo-corrected change from baseline|-0.7|||||TWO_SIDED|90.0|-1.9|0.4||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||0.4|-1.9|
74029280|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-21.17|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-29.04|-13.3||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-13.30|-29.04|<0.001
73926998|NCT02932904|147381794|SUPERIORITY||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.886||0.645|TWO_SIDED|95.0|-1.33|2.15|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.15|-1.33|0.645
73926999|NCT02932904|147381794|SUPERIORITY||LS Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|0.943||0.043|TWO_SIDED|95.0|0.06|3.77|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.77|0.06|0.043
73927000|NCT02932904|147381794|SUPERIORITY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|0.923||0.465|TWO_SIDED|95.0|-1.14|2.49|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.49|-1.14|0.465
73927001|NCT02932904|147381795|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.616||0.009|TWO_SIDED|95.0|-2.84|-0.41|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.41|-2.84|0.009
73927002|NCT02932904|147381795|SUPERIORITY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.834||0.123|TWO_SIDED|95.0|-2.93|0.35|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.35|-2.93|0.123
73927003|NCT02932904|147381795|SUPERIORITY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|0.892||0.039|TWO_SIDED|95.0|-3.61|-0.1|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.10|-3.61|0.039
73927004|NCT02932904|147381795|SUPERIORITY||LS Mean Difference|-2.49|STANDARD_ERROR_OF_MEAN|0.929||0.008|TWO_SIDED|95.0|-4.32|-0.66|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.66|-4.32|0.008
73927005|NCT02932904|147381795|SUPERIORITY||LS Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|1.024||0.007|TWO_SIDED|95.0|-4.78|-0.75|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.75|-4.78|0.007
73927006|NCT02932904|147381796|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.612||0.419|TWO_SIDED|95.0|-1.7|0.71|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.71|-1.70|0.419
73927007|NCT02932904|147381796|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.6||0.581|TWO_SIDED|95.0|-1.51|0.85|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.85|-1.51|0.581
73927008|NCT02932904|147381796|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.828||0.938|TWO_SIDED|95.0|-1.69|1.56|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.56|-1.69|0.938
73927009|NCT02932904|147381796|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.814||0.592|TWO_SIDED|95.0|-2.04|1.17|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.17|-2.04|0.592
74029281|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-16.67|STANDARD_ERROR_OF_MEAN|4.1|<|0.001|TWO_SIDED|95.0|-24.73|-8.61||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-8.61|-24.73|<0.001
73927010|NCT02932904|147381796|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.886||0.87|TWO_SIDED|95.0|-1.6|1.89|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.89|-1.60|0.870
73927011|NCT02932904|147381796|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.871||0.098|TWO_SIDED|95.0|-3.16|0.27|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.27|-3.16|0.098
73927012|NCT02932904|147381796|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.923||0.532|TWO_SIDED|95.0|-2.39|1.24|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.24|-2.39|0.532
73927013|NCT02932904|147381796|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.907||0.046|TWO_SIDED|95.0|-3.6|-0.03|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.03|-3.60|0.046
73927014|NCT02932904|147381796|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.018||0.977|TWO_SIDED|95.0|-2.03|1.97|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.97|-2.03|0.977
73927015|NCT02932904|147381796|SUPERIORITY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.0||0.087|TWO_SIDED|95.0|-3.68|0.25|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.25|-3.68|0.087
73927016|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.515|TWO_SIDED|95.0|0.037|5.201|||Regression, Logistic|||Week 1||5.201|0.037|0.515
73969476|NCT05256017|147478289|OTHER||Placebo-corrected change from baseline|-10.9|||||TWO_SIDED|90.0|-15.3|-6.6||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-6.6|-15.3|
73969477|NCT05256017|147478290|OTHER||Placebo-corrected change from baseline|-11.5|||||TWO_SIDED|90.0|-14.4|-8.7||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-8.7|-14.4|
74029282|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-18.89|STANDARD_ERROR_OF_MEAN|4.05|<|0.001|TWO_SIDED|95.0|-26.84|-10.94||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-10.94|-26.84|<0.001
74029283|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-17.88|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-25.77|-9.99||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-9.99|-25.77|<0.001
74029284|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-19.5|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-27.28|-11.72||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-11.72|-27.28|<0.001
74029285|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-20.32|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.3|-12.35||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-12.35|-28.30|<0.001
74029286|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-22.14|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-30.0|-14.28||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-14.28|-30.00|<0.001
73927017|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.59||||0.677|TWO_SIDED|95.0|0.049|7.051|||Regression, Logistic|||Week 1||7.051|0.049|0.677
74029287|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-20.08|STANDARD_ERROR_OF_MEAN|4.13|<|0.001|TWO_SIDED|95.0|-28.19|-11.96||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-11.96|-28.19|<0.001
74029288|NCT04003155|147612902|SUPERIORITY||LSMean Difference|-24.18|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-32.16|-16.2||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-16.20|-32.16|<0.001
74029289|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|3.245|||<|0.001|TWO_SIDED|95.0|1.823|5.999||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||5.999|1.823|<0.001
74029290|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.964|||<|0.001|TWO_SIDED|95.0|1.658|5.497||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||5.497|1.658|<0.001
74029291|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.187||||0.001|TWO_SIDED|95.0|1.363|3.549||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||3.549|1.363|0.001
74029292|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.847|||<|0.001|TWO_SIDED|95.0|1.786|4.601||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.601|1.786|<0.001
73927018|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.47||||0.72|TWO_SIDED|95.0|0.181|11.912|||Regression, Logistic|||Week 1||11.912|0.181|0.720
73927019|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.65||||0.732|TWO_SIDED|95.0|0.053|7.861|||Regression, Logistic|||Week 1||7.861|0.053|0.732
73927020|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.87||||0.913|TWO_SIDED|95.0|0.066|11.303|||Regression, Logistic|||Week 1||11.303|0.066|0.913
73927021|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.37||||0.164|TWO_SIDED|95.0|0.09|1.507|||Regression, Logistic|||Week 2||1.507|0.090|0.164
73927022|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.25||||0.098|TWO_SIDED|95.0|0.05|1.287|||Regression, Logistic|||Week 2||1.287|0.050|0.098
73927023|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.2||||0.758|TWO_SIDED|95.0|0.383|3.731|||Regression, Logistic|||Week 2||3.731|0.383|0.758
73927024|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.256|TWO_SIDED|95.0|0.107|1.814|||Regression, Logistic|||Week 2||1.814|0.107|0.256
73927025|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.3||||0.154|TWO_SIDED|95.0|0.059|1.561|||Regression, Logistic|||Week 2||1.561|0.059|0.154
73927026|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.36||||0.16|TWO_SIDED|95.0|0.087|1.497|||Regression, Logistic|||Week 3||1.497|0.087|0.160
73927027|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.744|TWO_SIDED|95.0|0.252|2.679|||Regression, Logistic|||Week 3||2.679|0.252|0.744
73927028|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.43||||0.194|TWO_SIDED|95.0|0.636|9.317|||Regression, Logistic|||Week 3||9.317|0.636|0.194
73927029|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.88||||0.871|TWO_SIDED|95.0|0.181|4.261|||Regression, Logistic|||Week 3||4.261|0.181|0.871
73969478|NCT05256017|147478291|OTHER||Placebo-corrected change from baseline|-11.7|||||TWO_SIDED|90.0|-14.9|-8.6||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-8.6|-14.9|
73969479|NCT05256017|147478292|OTHER||Estimate|-10.7|STANDARD_DEVIATION|1.72|||TWO_SIDED|90.0|-13.5|-7.85||||||Estimated ΔΔQTcF (in ms) computed from a concentration-response (C-R) model between dry blood spot concentration of acoziborole and changes from baseline in QTcF parameter||-7.85|-13.5|
73969480|NCT03536754|147478310|SUPERIORITY||LSM Ratio|1.23|STANDARD_ERROR_OF_MEAN|1.171||0.1924|TWO_SIDED|90.0|0.95|1.6||≤ 0.1924|Mixed effects model for repeated measure|||||1.6|0.95|0.1924
73969481|NCT03536754|147478310|SUPERIORITY||LSM Ratio|1.35|STANDARD_ERROR_OF_MEAN|1.172||0.0612|TWO_SIDED|90.0|1.04|1.76||≤ 0.0612|Mixed effects model for repeated measure|||||1.76|1.04|0.0612
73969482|NCT03536754|147478310|SUPERIORITY||LSM Ratio|1.05|STANDARD_ERROR_OF_MEAN|1.169||0.7653|TWO_SIDED|90.0|0.81|1.36||≤ 0.7653|Mixed effects model for repeated measure|||||1.36|0.81|0.7653
73969483|NCT03536754|147478310|SUPERIORITY||LSM Ratio|1.2|STANDARD_ERROR_OF_MEAN|1.136||0.1537|TWO_SIDED|90.0|0.97|1.48||≤ 0.1537|Mixed effects model for repeated measure|||||1.48|0.97|0.1537
73969484|NCT05486078|147478510|OTHER|Repeated measures ANOVA||||||0.001|||||||ANOVA|||Hip abduction strength was analyzed using repeated measures ANOVA. The assumption of sphericity was tested and Bonferroni correction was applied for pairwise comparisons. A p-value \< 0.001 was considered statistically significant.||||0.001
73969485|NCT05486078|147478511|OTHER|McNemar Exact Test|||||<|0.0001||||||P-value derived from McNemar exact test comparing binary outcome (improved vs. unchanged). Statistical significance threshold set at p \< 0.05.|McNemar|McNemar Exact Test||MRI improvement was assessed using paired evaluation of inflammatory signs (edema) at baseline and Week 24. McNemar exact test was used for within-subject categorical comparison.||||< 0.0001
73969486|NCT05486078|147478512|OTHER|Friedman Test Within-group||||||0.992|||||||Friedman Test Within-group|||Analgesic use (units/week) was analyzed over time using the Friedman test for repeated measures. No significant variation across follow-up visits was found.||||0.992
73969487|NCT03897465|147478591|NON_INFERIORITY|Pre-specified non-inferiority margin was 10%|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-10.0||Upper Limit= +Infinity|||||Descriptive analysis of the primary endpoint was provided on per protocol population. The overall difference LomatuellPro (LP) - UrgoTul (UT) of the % of patients meeting main efficacy criterion was calculated with 95% bilateral confidence interval (CI). If lower limit of the 95% CI did not exceed the -10% value of pre-specified non-inferiority margin, non-inferiority had to be accepted. As a sensitivity analysis, the same analysis was performed on mITT (modified Intention-to-treat) population.|||-10|
73969488|NCT02132936|147478640|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55|||<|0.001|TWO_SIDED|95.0|1.46|4.46|||Mantel Haenszel|||"Mantel-Haenszel odds of treatment success in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing PGA values."||4.46|1.46|<0.001
73969489|NCT02132936|147478641|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18|||=|0.001|TWO_SIDED|95.0|1.37|3.47|||Mantel Haenszel|||"Mantel-Haenszel odds of having PASI 75 in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing data."||3.47|1.37|=0.001
73969490|NCT02132936|147478642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
73969491|NCT02132936|147478643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.||||<0.001
73969492|NCT02132936|147478644|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.33|TWO_SIDED||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.||||=0.33
74087844|NCT01730040|147729614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.1|||=|0.0004|TWO_SIDED|99.0|-36.3|-5.9||Threshold for significance ≤ 0.01.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-5.9|-36.3|=0.0004
74087845|NCT01730040|147729614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.9|||<|0.0001|TWO_SIDED|99.0|-40.2|-11.6||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-40.2|<0.0001
74087846|NCT01730040|147729614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.0|||<|0.0001|TWO_SIDED|99.0|-45.6|-16.4||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.4|-45.6|<0.0001
74087847|NCT01730040|147729615|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||=|0.4456|TWO_SIDED|99.0|-7.0|12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification).||12.9|-7.0|=0.4456
74087848|NCT01552369|147729622|SUPERIORITY|||||||0.0396|||||||Mantel Haenszel|||||||0.0396
74087849|NCT01552369|147729622|SUPERIORITY||Hazard Ratio (HR)|2.22||||0.048|TWO_SIDED|95.0|1.01|7.3|||Competing risk regression|Death was considered a competing risk.|The risk of CMV disease is 2.2x higher in the prophylaxis group when compared to the preemptive group|||7.3|1.01|0.048
74087850|NCT01552369|147729623|SUPERIORITY|log-rank test for equality of survivor functions||||||0.19|||||||Log Rank|||||||0.19
73969493|NCT03839940|147478722|SUPERIORITY||||||<|0.9999|||||||Fisher Exact|||||||< 0.9999
73969494|NCT03839940|147478723|SUPERIORITY|||||||0.3346|||||||Wilcoxon (Mann-Whitney)|||||||0.3346
73969495|NCT03839940|147478739|SUPERIORITY||||||<|0.70361|||||||Fisher Exact|||Female Population.||||< 0.70361
74087851|NCT01552369|147729624|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6|TWO_SIDED|95.0|0.45|1.58|||Mantel Haenszel||The odds of rejection in prophylaxis group compared to preemptive group|||1.58|0.45|0.60
74087852|NCT01552369|147729625|SUPERIORITY||Odds Ratio (OR)|0.95||||0.96|TWO_SIDED|95.0|0.13|6.92|||Mantel Haenszel||The odds of graft loss in prophylaxis group compared to preemptive group|||6.92|0.13|0.96
74087853|NCT01552369|147729626|SUPERIORITY||Odds Ratio (OR)|3.24||||0.014|TWO_SIDED|95.0|1.21|8.69|||Mantel Haenszel||Odds of late disease in prophylaxis group compared to preemptive|||8.69|1.21|0.014
73969496|NCT03839940|147478739|SUPERIORITY||||||<|0.4667|||||||Fisher Exact|||Male population.||||<0.4667
73969497|NCT03839940|147478740|SUPERIORITY||||||<|1|||||||Fisher Exact|||Black or African American population||||<1.0
73969498|NCT03839940|147478740|SUPERIORITY||||||<|1|||||||Fisher Exact|||White population||||<1.0
73969499|NCT03839940|147478741|SUPERIORITY||||||<|1|||||||Fisher Exact|||Not Hispanic or Latino population.||||<1.0
73969500|NCT03839940|147478742|SUPERIORITY||||||<|0.1701|||||||Wilcoxon (Mann-Whitney)|||Female population.||||<0.1701
73969501|NCT03839940|147478742|SUPERIORITY||||||<|0.4811|||||||Wilcoxon (Mann-Whitney)|||Male population.||||<0.4811
73969502|NCT03839940|147478743|SUPERIORITY||||||<|1|||||||Wilcoxon (Mann-Whitney)|||Black or African American Population||||<1.0
74087854|NCT01552369|147729627|SUPERIORITY||Odds Ratio (OR)|1.17||||0.64|TWO_SIDED|95.0|0.61|2.23|||Mantel Haenszel||Odds of bacterial infection in prophylaxis subjects compared to preemptive|||2.23|0.61|0.64
73969503|NCT03839940|147478743|SUPERIORITY||||||<|0.5029|||||||Wilcoxon (Mann-Whitney)|||White Population||||<0.5029
73969504|NCT03839940|147478744|SUPERIORITY||||||<|0.295|||||||Wilcoxon (Mann-Whitney)|||Not Hispanic or Latino Population||||<0.2950
74087855|NCT01552369|147729628|SUPERIORITY||Odds Ratio (OR)|2.25||||0.18|TWO_SIDED|95.0|0.66|7.62|||Mantel Haenszel||Odds of fungal disease in prophylaxis group compared to preemptive|||7.62|0.66|0.18
74087856|NCT01552369|147729629|SUPERIORITY|||||||0.24|||||||Fisher Exact|||||||0.24
74087857|NCT01552369|147729630|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
74087858|NCT01552369|147729631|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.57
73927030|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.0||||0.329|TWO_SIDED|95.0|0.497|8.037|||Regression, Logistic|||Week 3||8.037|0.497|0.329
73927031|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.42||||0.187|TWO_SIDED|95.0|0.119|1.514|||Regression, Logistic|||Week 4||1.514|0.119|0.187
74029293|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.096||||0.002|TWO_SIDED|95.0|1.326|3.345||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.345|1.326|0.002
73927032|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.729|TWO_SIDED|95.0|0.273|2.476|||Regression, Logistic|||Week 4||2.476|0.273|0.729
73927033|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.71||||0.133|TWO_SIDED|95.0|0.739|9.917|||Regression, Logistic|||Week 4||9.917|0.739|0.133
74029294|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|3.333|||<|0.001|TWO_SIDED|95.0|2.121|5.302||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||5.302|2.121|<0.001
74087859|NCT01552369|147729632|SUPERIORITY|||||||0.61|||||||Chi-squared|||||||0.61
74087860|NCT02631837|147729633|NON_INFERIORITY|Our hypothesis was that women would accept a higher conversion rate of 15% for vNOTESbased on a telephone interview of 10 women treated by total vaginal NOTES hysterectomy. Women were asked to choose among ﬁve cut-off rates (5, 10, 15, 20 or 25%). Most women indicated 15%. We would conclude non-inferiority when the upper limit of the one-sided 95% conﬁdence interval for the difference in the proportions of women between both comparisons would be below 15%.||||||0.0221||||||The Farrington-Manning test for non-inferiority was performed with 5% significance level and yielded P = 0.0221 in a sensitivity analysis assuming one conversion in the vNOTES and 0 conversions in the laparoscopy group.|Farrington-Manning|||||||0.0221
73927034|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.852|TWO_SIDED|95.0|0.266|4.961|||Regression, Logistic|||Week 4||4.961|0.266|0.852
73927035|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.23||||0.24|TWO_SIDED|95.0|0.585|8.472|||Regression, Logistic|||Week 4||8.472|0.585|0.240
73927036|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.55||||0.317|TWO_SIDED|95.0|0.166|1.789|||Regression, Logistic|||Week 5||1.789|0.166|0.317
73927037|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.79|TWO_SIDED|95.0|0.41|3.233|||Regression, Logistic|||Week 5||3.233|0.410|0.790
73969505|NCT00085735|147478758|NON_INFERIORITY|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis of comparing LDCSI vs. SDCSI, a one-sided 80% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by RT group (IFRT vs. PFRT)). If the upper confidence limit is lower than 1.6, LDCSI would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.5|||||ONE_SIDED|80.0||1.9||||||The comparison is based on all eligible randomized patients 3-7 years of age without anaplastic histology or excess residual disease or disseminated disease by central review per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed to have power of 0.80 to detect a 10% reduction in cure rate due to the use of LDCSI compared to SDCSI.||1.9||
74029295|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.061||||0.001|TWO_SIDED|95.0|1.323|3.233||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||3.233|1.323|0.001
74029296|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|3.025|||<|0.001|TWO_SIDED|95.0|1.947|4.746||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.746|1.947|<0.001
74029297|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.363|3.357||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||3.357|1.363|<0.001
74029298|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|3.223|||<|0.001|TWO_SIDED|95.0|2.067|5.08||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||5.080|2.067|<0.001
74029299|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.049||||0.002|TWO_SIDED|95.0|1.317|3.21||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.210|1.317|0.002
74087861|NCT02631837|147729634|SUPERIORITY||Risk Difference (RD)|-0.34||||0.007|TWO_SIDED|95.0|-0.56|-0.13|||Fisher Exact|||||-0.13|-0.56|0.007
74087862|NCT02631837|147729634|SUPERIORITY|||||||0.007|||||||Fisher Exact|||||||0.007
74087863|NCT02631837|147729636|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.006|TWO_SIDED|95.0|-10.0|-1.8|||Mann-Whitney U test|Two-sided test||||-1.8|-10|0.006
74087864|NCT02631837|147729637|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
74087865|NCT02631837|147729638|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||> 0.05
74087866|NCT02631837|147729639|SUPERIORITY||Risk Difference (RD)|-0.29||||0.009|TWO_SIDED|95.0|-0.47|-0.1|||Fisher Exact|||||-0.10|-0.47|0.009
74087867|NCT02631837|147729640|SUPERIORITY|||||||0.106|||||||Fisher Exact|||||||0.106
74029300|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|3.097|||<|0.001|TWO_SIDED|95.0|1.994|4.858||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.858|1.994|<0.001
74087868|NCT02631837|147729641|SUPERIORITY||Median Difference (Final Values)|-34.0|||<|0.01|TWO_SIDED|95.0|-46.0|-22.0|||Mann-Whitney U test|||||-22|-46|< 0.01
74087869|NCT02631837|147729642|SUPERIORITY|||||||0.7604||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.7604
74087870|NCT02631837|147729643|SUPERIORITY|||||||0.3071||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3071
74087871|NCT02631837|147729644|SUPERIORITY|||||||0.4541||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.4541
74087872|NCT02631837|147729645|SUPERIORITY|||||||0.4514||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.4514
74087873|NCT02631837|147729646|SUPERIORITY|||||||0.3473||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3473
74087874|NCT02631837|147729647|SUPERIORITY|We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.||||||0.3473||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3473
74087875|NCT02631837|147729649|SUPERIORITY||Mean Difference (Final Values)|-555.8||||0.11|TWO_SIDED|95.0||36.0|||Mann-Whitney U test|||||36|-1,044|0.110
74087876|NCT02597582|147729666|NON_INFERIORITY_OR_EQUIVALENCE|"A previous study found that the mean operation time was 165 minutes for patients undergoing LigaSure vessel sealing system-assisted total laryngectomy plus neck dissection and 195 minutes for those receiving conventional hemostasis.~With a difference in operative duration of 30 minutes between the two groups,9 the estimated sample size needed to demonstrate a two-sided significance level of 0.05 with 80% power should be at least 18 participants in each treatment arm."||||||0.022|||||||t-test, 2 sided|||||||0.022
74087877|NCT02597582|147729667|NON_INFERIORITY_OR_EQUIVALENCE|As above||||||0.266|||||||t-test, 2 sided|||||||0.266
74087878|NCT02597582|147729668|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.06|||||||t-test, 2 sided|||||||0.060
74087879|NCT02597582|147729670|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.524|||||||t-test, 2 sided|||||||0.524
74087880|NCT02597582|147729671|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.037|||||||Wilcoxon (Mann-Whitney)|||||||0.037
74087881|NCT02997657|147729678|SUPERIORITY|||||||0.71|||||||Chi-squared|||||||0.71
74087882|NCT02997657|147729679|SUPERIORITY|||||||0.81|||||||Chi-squared|||||||0.81
74087883|NCT02997657|147729680|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
74087884|NCT02997657|147729681|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
74087885|NCT02997657|147729682|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
74087886|NCT02997657|147729683|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
74087887|NCT02997657|147729684|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
74087888|NCT01567826|147729711|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|||||||0.01
74087889|NCT01567826|147729712|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||||||0.02
74087890|NCT02062801|147729719|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Chi-squared|||||||0.18
74087891|NCT02062801|147729720|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Chi-squared|||||||0.97
74029301|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|1.984||||0.002|TWO_SIDED|95.0|1.28|3.097||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.097|1.280|0.002
74029302|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|3.062|||<|0.001|TWO_SIDED|95.0|1.977|4.788||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||4.788|1.977|<0.001
74029303|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.748|||<|0.001|TWO_SIDED|95.0|1.774|4.294||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||4.294|1.774|<0.001
74087892|NCT02062801|147729721|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Chi-squared|||||||.56
74087893|NCT01612884|147729722|OTHER|Student's T-test||||||0.85|||||||t-test, 2 sided|||||||0.85
74087894|NCT01612884|147729723|OTHER|Chi-Square||||||0.93|||||||Chi-squared|||||||0.93
74087895|NCT01612884|147729724|OTHER|Chi-Square|||||>|0.05|||||||Chi-squared|||||||>0.05
73969506|NCT00085735|147478758|NON_INFERIORITY|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis comparing IFRT vs. PFRT, a one-sided 94% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by age group and RT group (LDCSI vs. SDCSI)). If the upper confidence limit is lower than 1.6, IFRT would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.0|||||ONE_SIDED|94.0||1.3||||||The comparison is based on all eligible randomized patients 3-21 years of age without anaplastic histology or excess residual disease or disseminated disease by central review as per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed with power of 0.94 to detect a 10% reduction in cure rate and power of 0.65 to detect a 5% reduction in cure rate, due to the use of IFRT compared to PFRT.||1.3||
73969507|NCT04473222|147478784|SUPERIORITY||Odds Ratio, log|-0.15||||0.026|TWO_SIDED||||||t-test, 2 sided||The logit represents the difference in log odds per 1-week change in time for the intervention group relative to enhanced usual care.|||||.026
73969508|NCT04473222|147478785|SUPERIORITY||Odds Ratio, log|-0.2||||0.032|TWO_SIDED||||||t-test, 2 sided||The logit represents the difference in log odds per 1-week change in time for the intervention group relative to enhanced usual care.|||||0.032
74087896|NCT02790034|147729739|SUPERIORITY||Mean Difference (Final Values)|-5.292|STANDARD_ERROR_OF_MEAN|11.3184||0.6411|TWO_SIDED|95.0|-27.741|17.157|||Mixed Models Analysis|||Primary inferential comparison between treatment groups used a restricted maximum likelihood (REML)-based, mixed-effects repeated measures model approach (MMRM) with 95% CI for the difference between treatment groups for % change from baseline in the number of apnea episodes. Model included % change from baseline as response, the fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, and the continuous terms age and baseline value as covariate.||17.157|-27.741|0.6411
74087897|NCT02790034|147729739|SUPERIORITY||Mean Difference (Final Values)|-16.966|STANDARD_ERROR_OF_MEAN|13.1869||0.2011|TWO_SIDED|95.0|-43.119|9.186|||Mixed Models Analysis|||Primary inferential comparison between treatment groups used a restricted maximum likelihood (REML)-based, mixed-effects repeated measures model approach (MMRM) with 95% CI for the difference between treatment groups for % change from baseline in the number of apnea episodes. Model included % change from baseline as response, the fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, and the continuous terms age and baseline value as covariate.||9.186|-43.119|0.2011
74087898|NCT03440424|147729746|OTHER||Percent ratio of geometric mean|157.86|||||TWO_SIDED|90.0|118.18|210.87|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||210.87|118.18|
74087899|NCT03440424|147729746|OTHER||Percent ratio of geometric mean|122.2|||||TWO_SIDED|90.0|91.49|163.24|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||163.24|91.49|
74087900|NCT03440424|147729747|OTHER||Percent ratio of geometric mean|122.31|||||TWO_SIDED|90.0|98.95|151.17|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||151.17|98.95|
73969509|NCT04473222|147478786|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.009||0.01|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||.010
74087901|NCT03440424|147729747|OTHER||Percent ratio of geometric mean|103.24|||||TWO_SIDED|90.0|83.53|127.61|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||127.61|83.53|
74087902|NCT03440424|147729748|OTHER||Percent ratio of geometric mean|125.26|||||TWO_SIDED|90.0|96.76|162.16|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||162.16|96.76|
74087903|NCT03440424|147729748|OTHER||Percent ratio of geometric mean|115.2|||||TWO_SIDED|90.0|88.98|149.13|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||149.13|88.98|
74087904|NCT03440424|147729749|OTHER||Percent ratio of geometric mean|131.91|||||TWO_SIDED|90.0|96.46|180.4|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||180.40|96.46|
74087905|NCT03440424|147729749|OTHER||Percent ratio of geometric mean|149.52|||||TWO_SIDED|90.0|109.34|204.47|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||204.47|109.34|
74087906|NCT03440424|147729750|OTHER||Percent ratio of geometric mean|125.03|||||TWO_SIDED|90.0|87.96|177.74|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||177.74|87.96|
74087907|NCT03440424|147729750|OTHER||Percent ratio of geometric mean|153.56|||||TWO_SIDED|90.0|106.39|221.66|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||221.66|106.39|
74087908|NCT03440424|147729751|OTHER||Percent ratio of geometric mean|128.88|||||TWO_SIDED|90.0|88.35|188.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||188.02|88.35|
74087909|NCT03440424|147729751|OTHER||Percent ratio of geometric mean|166.55|||||TWO_SIDED|90.0|112.31|246.99|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||246.99|112.31|
74087910|NCT03440424|147729752|OTHER||Percent ratio of geometric mean|96.97|||||TWO_SIDED|90.0|70.15|134.06|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||134.06|70.15|
74087911|NCT03440424|147729752|OTHER||Percent ratio of geometric mean|72.05|||||TWO_SIDED|90.0|52.12|99.6|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||99.60|52.12|
73927038|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|3.64||||0.073|TWO_SIDED|95.0|0.888|14.911|||Regression, Logistic|||Week 5||14.911|0.888|0.073
73927039|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.98||||0.371|TWO_SIDED|95.0|0.442|8.902|||Regression, Logistic|||Week 5||8.902|0.442|0.371
73927040|NCT02932904|147381797|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|4.19||||0.046|TWO_SIDED|95.0|1.027|17.063|||Regression, Logistic|||Week 5||17.063|1.027|0.046
73927041|NCT02932904|147381800|SUPERIORITY||LS Mean Difference|3.38|STANDARD_ERROR_OF_MEAN|1.082||0.002|TWO_SIDED|95.0|1.25|5.51||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||5.51|1.25|0.002
73927042|NCT02932904|147381800|SUPERIORITY||LS Mean Difference|1.63|STANDARD_ERROR_OF_MEAN|1.068||0.129|TWO_SIDED|95.0|-0.47|3.73||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.73|-0.47|0.129
73927043|NCT02932904|147381801|SUPERIORITY||LS Mean Difference|4.31|STANDARD_ERROR_OF_MEAN|1.078|<|0.001|TWO_SIDED|95.0|2.19|6.43||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||6.43|2.19|<0.001
73927044|NCT02932904|147381801|SUPERIORITY||LS Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|1.072||0.005|TWO_SIDED|95.0|0.95|5.17||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||5.17|0.95|0.005
73927045|NCT04414553|147381855|SUPERIORITY|||||||0.29||||||Threshold for statistical significance was \<0.05|t-test, 2 sided|||This compares pre/post data.||||0.29
73927046|NCT04414553|147381856|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
73927047|NCT04414553|147381857|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
73927048|NCT04414553|147381858|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
73927049|NCT04414553|147381859|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||||||0.062
73927050|NCT03969992|147381868|SUPERIORITY|||||||0.1924||||||A closed test procedure is used to protect the type I error rate; the order of testing was: AeroFact high dose compared to control and if significant (p-value \<0.05), the AeroFact low dose was compared to the control.|Generalized estimating equation method|||||||0.1924
73927051|NCT03317431|147381888|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD1 expression.||||<0.01
73927052|NCT03317431|147381889|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD2 expression.||||>0.01
73927053|NCT03317431|147381890|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with TH expression.||||>0.01
73927054|NCT03317431|147381891|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DDC expression.||||>0.01
73969510|NCT04473222|147478787|SUPERIORITY||Slope|0.009|STANDARD_ERROR_OF_MEAN|0.009||0.161|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.161
73927055|NCT03317431|147381892|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with Ac-a-tubulin expression.||||<0.01
73927056|NCT03519971|147381901|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.247|TWO_SIDED|95.0|0.647|1.123|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||The hazard ratio (HR) and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for age \[\< 65 versus (vs.) \>= 65 years\] and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.||1.123|0.647|0.247
73927057|NCT03519971|147381902|SUPERIORITY||Difference in percentages|0.2||||0.976|TWO_SIDED|99.5|-15.2|16.3|||Cochran-Mantel-Haenszel|The analysis was performed using a Cochran-Mantel-Haenszel (CMH) test, stratified by age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).|The CIs for difference in percentages were estimated using Miettinen and Nurminen's method.|||16.3|-15.2|0.976
73969511|NCT04473222|147478788|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.01||0.006|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.006
73927058|NCT03519971|147381903|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|1.03||||0.823|TWO_SIDED|95.0|0.778|1.386|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.386|0.778|0.823
73969512|NCT04473222|147478789|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.045|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.045
73969513|NCT04473222|147478790|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.685|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.685
73969514|NCT04473222|147478791|SUPERIORITY||Slope|0.42|STANDARD_ERROR_OF_MEAN|1.22||0.734|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.734
73969515|NCT04473222|147478792|SUPERIORITY||Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.019|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.019
73969516|NCT04473222|147478793|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.776|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.776
73969517|NCT04636528|147478820|EQUIVALENCE|A minimal detectable difference of 11.2 points was selected based on the psychometric properties of the scale. Considering a power of 80%, a 2-sided 0.05 significance level, and a 10% dropout rate, 82 patients would be necessary to detect an 11.2-point difference between the 2 groups.|Median Difference (Net)|-1.8||||0.75|TWO_SIDED|95.0|-13.5|9.8||The threshold for statistical significance was set at 0.05.|quantile mixed-effects model|a robust method on the medians||||9.8|-13.5|0.75
73969518|NCT04636528|147478820|EQUIVALENCE||Odds Ratio (OR)|0.84||||0.71|TWO_SIDED|95.0|0.32|2.16||The threshold for statistical significance was set at 0.05.|Regression, Logistic|||||2.16|0.32|0.71
73969519|NCT04636528|147478821|EQUIVALENCE||Median Difference (Net)|-0.6||||0.12|TWO_SIDED|95.0|-1.4|-0.2||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||-0.2|-1.4|0.12
73969520|NCT04636528|147478822|EQUIVALENCE||Median Difference (Net)|-2.2||||0.89|TWO_SIDED|95.0|-34.6|30.2||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|||||30.2|-34.6|0.89
73969521|NCT04636528|147478823|EQUIVALENCE||Median Difference (Net)|-0.3||||0.51|TWO_SIDED|95.0|-1.0|0.5|||Quantile mixed-effects model|a robust method on the medians||||0.5|-1.0|0.51
73969522|NCT04636528|147478824|EQUIVALENCE||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|t-test, 2 sided|||||||<0.001
73969523|NCT04636528|147478825|EQUIVALENCE||Median Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.5|0.6||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||0.6|-1.5|<.001
73969524|NCT04636528|147478826|EQUIVALENCE||Median Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||-0.5|-1.4|<.001
73969525|NCT04636528|147478827|EQUIVALENCE||Median Difference (Net)|-0.5||||0.27|TWO_SIDED|95.0|-1.3|0.4||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|A robust method on the medians.||||0.4|-1.3|.27
73969526|NCT04636528|147478828|EQUIVALENCE||Difference in proportions|11.8||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
73969527|NCT04636528|147478829|EQUIVALENCE||Mean Difference (Final Values)|12.7|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73969528|NCT04636528|147478830|EQUIVALENCE||Mean Difference (Final Values)|67.7||||0.36|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.36
73969529|NCT04636528|147478831|EQUIVALENCE||Mean Difference (Final Values)|1.62|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73969530|NCT04908722|147478850|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.15|||||TWO_SIDED|97.5|0.926|1.44||||||Group 1 (1 dose) vs Group 3 (1 dose)||1.440|0.926|
73969531|NCT04908722|147478850|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.8||||||97.5|0.641|1.0||||||Group 5 (1 dose) vs Group 3 (1 dose)||1.00|0.641|
73969532|NCT04908722|147478850|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.07|||||TWO_SIDED|97.5|0.844|1.356||||||Group 2 (1 dose) vs Group 3 (1 dose)||1.356|0.844|
73969533|NCT04908722|147478850|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.94|||||TWO_SIDED|97.5|0.742|1.193||||||Group 4 (1 dose) vs Group 3 (1 dose)||1.193|0.742|
73969534|NCT04908722|147478850|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.81|||||TWO_SIDED|97.5|0.648|1.007||||||Group 6 (1 dose) vs Group 3 (1 dose)||1.007|0.648|
73969535|NCT04908722|147478851|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.53|||||TWO_SIDED|97.5|1.992|3.207||||||Group 1 (2 doses) vs Group 3 (1 dose)||3.207|1.992|
73969536|NCT04908722|147478851|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.41|||||TWO_SIDED|97.5|1.088|1.815||||||Group 1 (2 doses) vs Group 3 (2 doses)||1.815|1.088|
73969537|NCT04908722|147478851|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.79|||||TWO_SIDED|97.5|1.408|2.265||||||Group 5 (2 doses) vs Group 3 (1 dose)||2.265|1.408|
73969538|NCT04908722|147478851|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.99|||||TWO_SIDED|97.5|0.769|1.282||||||Group 5 (2 doses) vs Group 3 (2 doses)||1.282|0.769|
73969539|NCT04908722|147478851|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.37|||||TWO_SIDED|97.5|1.829|3.007||||||Group 2 (2 doses) vs Group 3 (1 dose)||3.007|1.829|
73969540|NCT04908722|147478851|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.32|||||TWO_SIDED|97.5|1.0|1.739||||||Group 2 (2 doses) vs Group 3 (2 doses)||1.739|1.000|
73927059|NCT03519971|147381904|SUPERIORITY|For the comparison between treatments, the Kaplan-Meier estimator of survival at 24 months for each treatment was used to obtain the HR and the test is based on the method described in Klein 2007. To account for the stratification factors, the estimates and test statistics in each strata were combined by weighting inversely proportionately according to each within stratum variance.|Hazard Ratio (HR)|1.04||||0.847|TWO_SIDED|95.0|0.716|1.502|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.502|0.716|0.847
73927060|NCT03519971|147381905|SUPERIORITY|The analysis was performed using a CMH test, stratified by age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).|Difference in percentages|0.0|||||TWO_SIDED|95.0|-4.8|3.0|||||The CIs for difference in percentages was calculated using Miettinen and Nurminen's method.|||3.0|-4.8|
73927061|NCT03519971|147381908|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|0.95||||0.79|TWO_SIDED|95.0|0.649|1.413|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.413|0.649|0.790
73927062|NCT03519971|147381909|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|0.81||||0.132|TWO_SIDED|95.0|0.614|1.071|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.071|0.614|0.132
73927063|NCT04654117|147381919|SUPERIORITY|Multilevel model predicting the effect of the overall consultation model on manual adherence, averaged across clinicians.|unstandardized beta|0.33|STANDARD_ERROR_OF_MEAN|3.85|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
73927064|NCT04654117|147381920|SUPERIORITY||unstandardized beta|0.04|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
73927065|NCT04654117|147381921|OTHER|multilevel modeling|multilevel modeling|2.56|STANDARD_ERROR_OF_MEAN|0.74|<|0.05|TWO_SIDED||||||multilevel modeling|||||||<.05
73927066|NCT04654117|147381922|SUPERIORITY||ANOVA|17.0|||<|0.05|TWO_SIDED||||||ANOVA|||||||<.05
73927067|NCT04654117|147381923|OTHER|multilevel model|multilevel model|0.04|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
73927068|NCT04654117|147381924|OTHER|multilevel model|multilevel model (beta)|-0.27|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
73927069|NCT04544293|147381929|SUPERIORITY||Mean Difference (Net)|6.0||||0.0007|TWO_SIDED|95.0|2.5|9.4|||Mixed Models Analysis|Modelled using MMRM adjusted for baseline % predicted DLCOadj, treatment, visit, region, severity stratification and treatment-visit interaction.|Difference from placebo|||9.4|2.5|0.0007
73927070|NCT04544293|147381930|SUPERIORITY||Mean Difference (Net)|6.9||||0.0008|TWO_SIDED|95.0|2.9|10.9||Modelled using MMRM adjusted for baseline % predicted DLCOadj, treatment, visit, region, severity stratification and treatment-visit interaction.|Mixed Models Analysis||Difference from Placebo|||10.9|2.9|0.0008
73927071|NCT04544293|147381931|SUPERIORITY||Mean Difference (Net)|-6.59||||0.0072|TWO_SIDED|95.0|-11.4|-1.79|||Mixed Models Analysis|||||-1.79|-11.40|0.0072
73927072|NCT04544293|147381932|SUPERIORITY||Mean Difference (Net)|-7.81||||0.0149|TWO_SIDED|95.0|-14.1|-1.52|||Mixed Models Analysis|||||-1.52|-14.10|0.0149
73969541|NCT04908722|147478851|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.2|||||TWO_SIDED|97.5|1.697|2.841||||||Group 4 (2 doses) vs Group 3 (1 dose)||2.841|1.697|
73969542|NCT04908722|147478851|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.22|||||TWO_SIDED|97.5|0.928|1.606||||||Group 4 (2 doses) vs Group 3 (2 doses)||1.606|0.928|
73969543|NCT04908722|147478851|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.7|||||TWO_SIDED|97.5|1.348|2.148||||||Group 6 (2 doses) vs Group 3 (1 dose)||2.148|1.348|
73969544|NCT04908722|147478851|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.95|||||TWO_SIDED|97.5|0.736|1.217||||||Group 6 (2 doses) vs Group 3 (2 doses)||1.217|0.736|
73969545|NCT02319759|147478861|SUPERIORITY||Percent difference|39.7|||<|0.001|TWO_SIDED|95.0|25.3|54.1|||Cochran-Mantel-Haenszel|||||54.1|25.3|<0.001
73969546|NCT02319759|147478862|SUPERIORITY||Percentage (%) Difference|66.1|||<|0.001|TWO_SIDED|95.0|53.8|78.4|||Cochran-Mantel-Haenszel|||||78.4|53.8|<0.001
73969547|NCT02319759|147478863|SUPERIORITY||Least Square Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.471|-0.148|||MMRM|MMRM stands for Mixed-effects Model Repeated Measures||||-0.148|-0.471|<0.001
74029304|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.379|||<|0.001|TWO_SIDED|95.0|1.536|3.712||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||3.712|1.536|<0.001
74029305|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.051||||0.001|TWO_SIDED|95.0|1.329|3.186||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.186|1.329|0.001
74029306|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.701|||<|0.001|TWO_SIDED|95.0|1.75|4.204||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||4.204|1.750|<0.001
73927073|NCT04544293|147381933|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0845|TWO_SIDED|95.0|-0.06|0.89|||Mixed Models Analysis|||||0.89|-0.06|0.0845
73927074|NCT04544293|147381934|SUPERIORITY||Mean Difference (Net)|-4.87||||0.1046|TWO_SIDED|95.0|-10.76|1.01|||Mixed Models Analysis|||||1.01|-10.76|0.1046
73969548|NCT03131154|147478905|OTHER||Hazard Ratio (HR)|1.129|||||TWO_SIDED|95.0|0.643|1.982|||||Cox proportional hazards model|||1.982|0.643|
73969549|NCT03131154|147478906|OTHER||Hazard Ratio (HR)|2.619|||||TWO_SIDED|95.0|0.989|6.939|||||Cox proportional hazards model|||6.939|0.989|
73969550|NCT06424236|147478907|SUPERIORITY||Least square (LS) mean|-0.1166|STANDARD_DEVIATION|0.29505||0.0117|TWO_SIDED|95.0|-0.206|-0.0272|||Mixed Model for Repeated Measures (MMRM)|||Week 52: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.0272|-0.2060|0.0117
73969551|NCT06424236|147478907|OTHER||LS mean|-0.4648|STANDARD_DEVIATION|0.46591|<|0.0001|TWO_SIDED|95.0|-0.5971|-0.3326|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.3326|-0.5971|<0.0001
73969552|NCT06424236|147478907|OTHER||LS mean|-0.7062|STANDARD_DEVIATION|0.43787|<|0.0001|TWO_SIDED|95.0|-0.8821|-0.5303|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.5303|-0.8821|<0.0001
74029307|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.725|||<|0.001|TWO_SIDED|95.0|1.742|4.306||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||4.306|1.742|<0.001
74029308|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|3.921|||<|0.001|TWO_SIDED|95.0|2.505|6.214||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||6.214|2.505|<0.001
74029309|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.104|||<|0.001|TWO_SIDED|95.0|1.363|3.27||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.270|1.363|<0.001
73927075|NCT04544293|147381935|SUPERIORITY||Mean Difference (Net)|-5.99||||0.1216|TWO_SIDED|95.0|-13.57|1.59|||Mixed Models Analysis|||||1.59|-13.57|0.1216
73927076|NCT04544293|147381936|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.0234|TWO_SIDED|95.0|0.07|1.03|||Mixed Models Analysis||Change from baseline compared to placebo.|||1.03|0.07|0.0234
73927077|NCT04544293|147381937|SUPERIORITY||Mean Difference (Final Values)|-4.01||||0.1043|TWO_SIDED|95.0|-8.84|0.83|||Mixed Models Analysis|||||0.83|-8.84|0.1043
73927078|NCT04903249|147381955|OTHER|||||||0.137|||||||t-test, 2 sided|||||||0.137
73927079|NCT04903249|147381956|OTHER|||||||0.293|||||||t-test, 2 sided|||||||0.293
73927080|NCT04903249|147381957|OTHER|||||||0.609|||||||t-test, 2 sided|||||||0.609
73927081|NCT04903249|147381963|OTHER|||||||0.025|||||||t-test, 2 sided|||||||0.025
73927082|NCT04903249|147381964|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73927083|NCT04903249|147381965|OTHER|||||||0.327|||||||t-test, 2 sided|||||||.327
73927084|NCT04903249|147381966|OTHER|||||||0.479|||||||t-test, 2 sided|||||||0.479
73927085|NCT04903249|147381967|OTHER|||||||0.424|||||||t-test, 2 sided|||||||0.424
73927086|NCT04903249|147381968|OTHER|||||||0.279|||||||t-test, 2 sided|||||||0.279
73927087|NCT04903249|147381969|OTHER|||||||0.052|||||||t-test, 2 sided|||||||0.052
73927088|NCT04681482|147381970|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.54|0.7|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of MB between cohorts.||0.70|0.54|<0.001
73927089|NCT04681482|147381972|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.088|TWO_SIDED|95.0|0.66|1.03|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of stroke/SE between cohorts.||1.03|0.66|0.088
73927090|NCT04681482|147381974|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.6|0.76|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of net clinical benefit between cohorts.||0.76|0.60|<0.001
73927091|NCT03608774|147381983|SUPERIORITY||Risk Difference (RD)|0.26|||<|0.001|TWO_SIDED|95.0|0.16|0.36||Protocol pre-specified an interim analysis of the primary outcome using O'Brien-Fleming bounds to maintain an overall 5% alpha level. The trial was stopped at the interim analysis. P-value was derived using stage-wise ordering of the sample space.|Chi-squared||Protocol pre-specified an interim analysis of the primary outcome using O'Brien-Fleming bounds to maintain an overall 5% alpha level. The trial was stopped at the interim analysis. Estimates were derived using stage-wise ordering of the sample space.|||0.36|0.16|<0.001
73927092|NCT03608774|147381984|OTHER||Risk Difference (RD)|0.11|||||TWO_SIDED|95.0|0.0|0.22||||||||0.22|0.00|
73927093|NCT03608774|147381985|OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.01|0.21||||||||0.21|-0.01|
73927094|NCT03608774|147381986|OTHER||Risk Difference (RD)|0.26|||||TWO_SIDED|95.0|0.15|0.38||||||||0.38|0.15|
73927095|NCT03608774|147381987|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.28|0.7||||||||0.70|-0.28|
73927096|NCT03608774|147381988|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.28|0.7||||||||0.70|-0.28|
73969553|NCT06424236|147478908|SUPERIORITY|Recurrent progression was defined as any progression which was either the first increase in CDR-SB above baseline or any progression above the highest preceding post-baseline value identified as a progression, where progression above the preceding value must be observed at 2 consecutive measurements unless the progression occurs at the last measurement.|Hazard Ratio (HR)|1.32||||0.4535|TWO_SIDED|95.0|0.64|2.7|||Regression, Cox|||The time to recurrent progression in CDR - sum of boxes. Baseline Asymptomatic Participants: Estimate and confidence interval was based on the Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. The OLE gantenerumab mITT analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point.||2.70|0.64|0.4535
73969554|NCT06424236|147478908|OTHER|Recurrent progression was defined as any progression which was either the first increase in CDR-SB above baseline or any progression above the highest preceding post-baseline value identified as a progression, where progression above the preceding value must be observed at 2 consecutive measurements unless the progression occurs at the last measurement.|Hazard Ratio (HR)|1.18||||0.4848|TWO_SIDED|95.0|0.74|1.86|||Regression, Cox|||The time to recurrent progression in CDR - sum of boxes. Baseline Symptomatic Participants: Estimate and confidence interval was based on the Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. The OLE gantenerumab mITT analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point.||1.86|0.74|0.4848
73969555|NCT06424236|147478909|OTHER||Hazard Ratio (HR)|0.93||||0.8855|TWO_SIDED|95.0|0.33|2.58|||Regression, Cox|||Time to first progression in CDR-Global score. Baseline Asymptomatic Participants: Estimate and confidence interval was based on Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. Time to first progression was defined as time from baseline to first visit where CDR-Global Score was greater than baseline value, where progression must be observed at 2 consecutive measurements unless progression occurs at last measurement.||2.58|0.33|0.8855
73969556|NCT06424236|147478909|OTHER||Hazard Ratio (HR)|0.72||||0.4497|TWO_SIDED|95.0|0.3|1.69|||Regression, Cox|||Time to first progression in CDR-Global score. Baseline Symptomatic Participants: Estimate and confidence interval was based on Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. Time to first progression was defined as time from baseline to first visit where CDR-Global Score was greater than baseline value, where progression must be observed at 2 consecutive measurements unless progression occurs at last measurement.||1.69|0.30|0.4497
73969557|NCT06424236|147478910|SUPERIORITY||LS mean|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.76|TWO_SIDED|95.0|-0.46|0.33|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with compound symmetry covariance matrix.||0.33|-0.46|0.760
73969558|NCT06424236|147478910|OTHER||LS mean|-1.21|STANDARD_ERROR_OF_MEAN|0.715||0.093|TWO_SIDED|95.0|-2.63|0.2|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.20|-2.63|0.093
73969559|NCT06424236|147478911|OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.989|TWO_SIDED|95.0|-0.43|0.44|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.44|-0.43|0.989
73969560|NCT06424236|147478911|OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.533||0.714|TWO_SIDED|95.0|-0.86|1.25|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||1.25|-0.86|0.714
73969561|NCT06424236|147478912|OTHER||LS mean|-0.03|STANDARD_ERROR_OF_MEAN|0.077||0.738|TWO_SIDED|95.0|-0.18|0.13|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.13|-0.18|0.738
73969562|NCT06424236|147478912|OTHER||LS mean|0.19|STANDARD_ERROR_OF_MEAN|0.222||0.395|TWO_SIDED|95.0|-0.28|0.66|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.66|-0.28|0.395
73969563|NCT06424236|147478913|OTHER||LS mean|-2.176|STANDARD_DEVIATION|2.89551|<|0.0001|TWO_SIDED|95.0|-2.9469|-1.4051|||MMRM|||Week 56: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-1.4051|-2.9469|<0.0001
74029310|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|2.953|||<|0.001|TWO_SIDED|95.0|1.912|4.602||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.602|1.912|<0.001
74029311|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|1.894||||0.005|TWO_SIDED|95.0|1.22|2.961||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||2.961|1.220|0.005
74087912|NCT03440424|147729752|OTHER||Percent ratio of geometric mean|84.36|||||TWO_SIDED|90.0|60.21|118.19|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||118.19|60.21|
74087913|NCT03440424|147729752|OTHER||Percent ratio of geometric mean|65.7|||||TWO_SIDED|90.0|46.89|92.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||92.05|46.89|
74087914|NCT03440424|147729752|OTHER||Percent ratio of geometric mean|94.74|||||TWO_SIDED|90.0|68.37|131.3|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||131.30|68.37|
74087915|NCT03440424|147729752|OTHER||Percent ratio of geometric mean|76.56|||||TWO_SIDED|90.0|55.24|106.09|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||106.09|55.24|
73927097|NCT04477304|147382006|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.12|-0.07||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.07|-0.12|<0.001
73927098|NCT04477304|147382007|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.23|-0.16||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.16|-0.23|<0.001
73927099|NCT04477304|147382008|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.1|-0.06||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.06|-0.10|<0.001
73927100|NCT04477304|147382009|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.08|-0.03||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.03|-0.08|<0.001
73927101|NCT04477304|147382010|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.392|TWO_SIDED|95.0|-0.03|-0.01||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.01|-0.03|0.392
73927102|NCT04477304|147382011|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.13|-0.05||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.05|-0.13|<0.001
73927103|NCT05083442|147382020|SUPERIORITY||Mean Difference (Net)|0.8||||0.19|TWO_SIDED|95.0|-0.4|1.9|||ANCOVA||Estimated difference between groups from analysis of covariance with baseline fat mass included as the covariate.|Groups were compared using analysis of covariance with baseline included as the covariate.||1.9|-0.4|0.19
73927104|NCT05083442|147382021|SUPERIORITY||Mean Difference (Net)|0.3||||0.745|TWO_SIDED|95.0|-1.5|2.1|||ANCOVA||Estimated difference between groups from analysis of covariance with baseline fat mass included as the covariate.|Groups were compared using analysis of covariance with baseline included as the covariate.||2.1|-1.5|0.745
73927105|NCT00499096|147382025|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
73927106|NCT01067768|147382032|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.5|1.3|||||The primary outcome analysis was performed using relative risk (RR) between the rate of urinary tract infection per 1,000 days of exposure of the test subjects to intervention and that of patients undergoing routine care.|The sample size was calculated for the primary outcome. An infection rate 15 per 1,000 urinary catheter days in the control group and an expected reduction in the intervention group 40% clinically important effect. Mapping one to one, 5% alpha error and beta error 20%.||1.3|0.50|
73927107|NCT01067768|147382033|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||The difference between groups was evaluated with a U test Mann Whitney. The difference was statistically significant with p values less than 0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis: On average catheterization are the same in patients with daily review of the indication and control group patients||||0.016
73927108|NCT03387813|147382034|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1624|TWO_SIDED|95.0|0.74|1.05|||Anderson-Gill model (robust sandwich)|||||1.05|0.74|0.1624
73927109|NCT03387813|147382038|EQUIVALENCE|Clinical equivalence was met if the lower limit of the confidence interval (CI) of ln(HR) for the primary endpoint in Elevated NT-proBNP/BNP only vs. prior HFH only subjects is \> -0.2877 and the upper limit is \< 0.2877.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|90.0|0.44|0.6||||||||0.60|0.44|
73927110|NCT03387813|147382042|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0958|TWO_SIDED|95.0|0.7|1.03|||Anderson-Gill model (robust sandwich)|||||1.03|0.70|0.0958
73927111|NCT03387813|147382046|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0644|TWO_SIDED|95.0|0.68|1.01|||Anderson-Gill model (robust sandwich)|||||1.01|0.68|0.0644
73927112|NCT03387813|147382050|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8867|TWO_SIDED|95.0|0.61|1.77|||Anderson-Gill model (robust sandwich)|||||1.77|0.61|0.8867
73927113|NCT03387813|147382054|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7119|TWO_SIDED|95.0|0.7|1.7|||Anderson-Gill model (robust sandwich)|||||1.70|0.70|0.7119
73927114|NCT03387813|147382058|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|1.44||0.3484|TWO_SIDED|95.0|-4.16|1.47|||t-test, 1 sided|||||1.47|-4.16|0.3484
73927115|NCT03387813|147382058|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|1.47||0.6684|TWO_SIDED|95.0|-3.51|2.26|||t-test, 1 sided|||||2.26|-3.51|0.6684
73927116|NCT03387813|147382060|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|1.37||0.9901|TWO_SIDED|95.0|-2.68|2.71|||t-test, 1 sided|||||2.71|-2.68|0.9901
73927117|NCT03387813|147382060|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|1.41||0.2947|TWO_SIDED|95.0|-1.29|4.24|||t-test, 1 sided|||||4.24|-1.29|0.2947
73927118|NCT03387813|147382062|SUPERIORITY||Mean Difference (Final Values)|4.14|STANDARD_ERROR_OF_MEAN|7.36||0.5741|TWO_SIDED|95.0|-10.32|18.6|||t-test, 1 sided|||||18.60|-10.32|0.5741
73927119|NCT03387813|147382062|SUPERIORITY||Mean Difference (Final Values)|2.93|STANDARD_ERROR_OF_MEAN|7.81||0.7077|TWO_SIDED|95.0|-12.41|18.27|||t-test, 1 sided|||||18.27|-12.41|0.7077
74087916|NCT03440424|147729754|OTHER||Percent ratio of geometric mean|99.14|||||TWO_SIDED|90.0|76.91|127.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||127.81|76.91|
73927120|NCT03387813|147382065|EQUIVALENCE|Clinical equivalence was met if the lower limit of the CI of ln(HR) for the primary endpoint in Elevated NT-proBNP/BNP only vs. prior HFH only subjects is \> -0.2877 and the upper limit is \< 0.2877.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|90.0|0.38|0.55||||||||0.55|0.38|
73927121|NCT03387813|147382069|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
73927122|NCT03387813|147382073|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
73927123|NCT03387813|147382077|OTHER|||||||0.0001|||||||ANOVA|||||||0.0001
74087917|NCT03440424|147729754|OTHER||Percent ratio of geometric mean|69.66|||||TWO_SIDED|90.0|54.03|89.79|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||89.79|54.03|
74087918|NCT03440424|147729754|OTHER||Percent ratio of geometric mean|78.98|||||TWO_SIDED|90.0|62.88|99.21|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||99.21|62.88|
74087919|NCT03440424|147729754|OTHER||Percent ratio of geometric mean|63.2|||||TWO_SIDED|90.0|50.31|79.38|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||79.38|50.31|
74087920|NCT03440424|147729754|OTHER||Percent ratio of geometric mean|94.56|||||TWO_SIDED|90.0|68.5|130.51|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||130.51|68.50|
74087921|NCT03440424|147729754|OTHER||Percent ratio of geometric mean|71.81|||||TWO_SIDED|90.0|52.03|99.12|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||99.12|52.03|
74087922|NCT03440424|147729755|OTHER||Percent ratio of geometric mean|106.7|||||TWO_SIDED|90.0|83.95|135.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||135.62|83.95|
74087923|NCT03440424|147729755|OTHER||Percent ratio of geometric mean|85.68|||||TWO_SIDED|90.0|67.41|108.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||108.90|67.41|
74087924|NCT03440424|147729755|OTHER||Percent ratio of geometric mean|75.41|||||TWO_SIDED|90.0|62.28|91.31|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||91.31|62.28|
74087925|NCT03440424|147729755|OTHER||Percent ratio of geometric mean|76.0|||||TWO_SIDED|90.0|62.76|92.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||92.02|62.76|
74087926|NCT03440424|147729755|OTHER||Percent ratio of geometric mean|95.55|||||TWO_SIDED|90.0|71.92|126.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||126.94|71.92|
74087927|NCT03440424|147729755|OTHER||Percent ratio of geometric mean|74.48|||||TWO_SIDED|90.0|56.06|98.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||98.94|56.06|
74087928|NCT03440424|147729756|OTHER||Percent ratio of geometric mean|113.04|||||TWO_SIDED|90.0|85.16|150.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||150.05|85.16|
74087929|NCT03440424|147729756|OTHER||Percent ratio of geometric mean|103.74|||||TWO_SIDED|90.0|78.16|137.7|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||137.70|78.16|
74087930|NCT03440424|147729756|OTHER||Percent ratio of geometric mean|78.62|||||TWO_SIDED|90.0|62.57|98.78|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||98.78|62.57|
74087931|NCT03440424|147729756|OTHER||Percent ratio of geometric mean|101.0|||||TWO_SIDED|90.0|80.38|126.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||126.90|80.38|
74087932|NCT03440424|147729756|OTHER||Percent ratio of geometric mean|109.49|||||TWO_SIDED|90.0|81.07|147.88|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||147.88|81.07|
73862653|NCT00897390|147271200|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974||||||90.0|0.92|1.032||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.032|0.920|
73862654|NCT00897390|147271201|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.937|||||TWO_SIDED|90.0|0.864|1.016||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.016|0.864|
73862655|NCT00897390|147271201|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.964|||||TWO_SIDED|90.0|0.891|1.042||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.042|0.891|
73927124|NCT03387813|147382083|OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.39|0.54|||Anderson-Gill model (robust sandwich)|||||0.54|0.39|<0.0001
73927125|NCT03387813|147382084|OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.53|0.76|||Anderson-Gill model (robust sandwich)|||||0.76|0.53|<0.001
73927126|NCT03387813|147382089|SUPERIORITY||Least Square Means Difference (T vs C)|1.53|STANDARD_ERROR_OF_MEAN|0.64||0.016|TWO_SIDED|95.0|0.29|2.78|||Mixed Models Analysis|||Comparisons of PA Systolic Pressure at 6 months between Treatment vs Control group||2.78|0.29|0.0160
73927127|NCT03387813|147382089|SUPERIORITY||Least Square Means Difference (T vs C)|0.79|STANDARD_ERROR_OF_MEAN|0.39||0.0427|TWO_SIDED|95.0|0.03|1.56|||Mixed Models Analysis|||Comparisons of PA Diastolic Pressure at 6 months between Treatment vs Control group.||1.56|0.03|0.0427
73927128|NCT03387813|147382089|SUPERIORITY||Least Square Means Difference (T vs C)|1.13|STANDARD_ERROR_OF_MEAN|0.48||0.0188|TWO_SIDED|95.0|0.19|2.08|||Mixed Models Analysis|||Comparisons of PA Mean Pressure at 6 months between Treatment vs Control group.||2.08|0.19|0.0188
73969564|NCT06424236|147478913|OTHER||LS mean|-4.8434|STANDARD_DEVIATION|3.78771|<|0.0001|TWO_SIDED|95.0|-5.8609|-3.826|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-3.8260|-5.8609|<0.0001
73969565|NCT06424236|147478913|OTHER||LS mean|-5.762|STANDARD_DEVIATION|3.31129|<|0.0001|TWO_SIDED|95.0|-6.9679|-4.5561|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-4.5561|-6.9679|<0.0001
73969566|NCT06424236|147478914|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.022||0.055|TWO_SIDED|95.0|0.0|0.09|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with variance components covariance matrix.||0.09|0.00|0.055
73927129|NCT03387813|147382089|SUPERIORITY||Least Square Means Difference (T vs C)|0.63|STANDARD_ERROR_OF_MEAN|0.66||0.3405|TWO_SIDED|95.0|-0.66|1.92|||Mixed Models Analysis|||Comparisons of PA Systolic Pressure at 12 months between Treatment vs Control group.||1.92|-0.66|0.3405
73927130|NCT03387813|147382089|SUPERIORITY||Least Square Means Difference (T vs C)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6174|TWO_SIDED|95.0|-0.59|0.99|||Mixed Models Analysis|||Comparisons of PA Diastolic Pressure at 12 months between Treatment vs Control group.||0.99|-0.59|0.6174
73927131|NCT03387813|147382089|SUPERIORITY||Least Square Means Difference (T vs C)|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.4231|TWO_SIDED|95.0|-0.58|1.38|||Mixed Models Analysis|||Comparisons of PA Mean Pressure at 12 months between Treatment vs Control group.||1.38|-0.58|0.4231
74029312|NCT04003155|147612903|SUPERIORITY||Odds Ratio (OR)|3.156|||<|0.001|TWO_SIDED|95.0|2.035|4.944||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||4.944|2.035|<0.001
73927132|NCT03387813|147382090|SUPERIORITY|||||||0.0214|||||||t-test, 2 sided|||Comparison of PA Systolic Pressure AUC between Treatment and Control group.||||0.0214
73927133|NCT03387813|147382090|OTHER|||||||0.1002|||||||t-test, 2 sided|||Comparison of PA Diastolic Pressure AUC between Treatment and Control group.||||0.1002
74029313|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|3.158||||0.322|TWO_SIDED|95.0|0.398|64.304||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||64.304|0.398|0.322
74029314|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|3.925||||0.225|TWO_SIDED|95.0|0.569|77.353||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||77.353|0.569|0.225
73927134|NCT03387813|147382090|OTHER|||||||0.0402|||||||t-test, 2 sided|||Comparison of PA Mean Pressure AUC between Treatment and Control group.||||0.0402
73927135|NCT03387813|147382091|SUPERIORITY||Least Square Means Difference (T vs C)|37.19|STANDARD_ERROR_OF_MEAN|75.52||0.6227|TWO_SIDED|95.0|-111.38|185.77|||Mixed Models Analysis|||Comparisons of change from baseline in BNP levels at 6 months between Treatment vs Control group||185.77|-111.38|0.6227
73927136|NCT03387813|147382092|SUPERIORITY||Least Square Means Difference (T vs C)|59.78|STANDARD_ERROR_OF_MEAN|76.87||0.4373|TWO_SIDED|95.0|-91.44|211.01|||Mixed Models Analysis|||Comparisons of change from baseline in BNP levels at 12 months between Treatment vs Control group||211.01|-91.44|0.4373
73927137|NCT03387813|147382093|SUPERIORITY||Least Square Means Difference (T vs C)|468.1|STANDARD_ERROR_OF_MEAN|256.65||0.0692|TWO_SIDED|95.0|-37.09|973.3|||Mixed Models Analysis|||Comparisons of change from baseline in NT-proBNP levels at 6months between Treatment vs Control group||973.30|-37.09|0.0692
73927138|NCT03387813|147382094|SUPERIORITY||Least Square Means Difference (T vs C)|284.67|STANDARD_ERROR_OF_MEAN|268.72||0.2903|TWO_SIDED|95.0|-244.27|813.6|||Mixed Models Analysis|||Comparisons of change from baseline in NT-proBNP levels at 12 months between Treatment vs Control group||813.60|-244.27|0.2903
73927139|NCT03387813|147382095|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.78|||Anderson-Gill model (robust sandwich)|||||0.78|0.53|<0.0001
73927140|NCT03387813|147382096|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.57|0.81|||Anderson-Gill model (robust sandwich)|||||0.81|0.57|<0.0001
73927141|NCT03792672|147382126|SUPERIORITY||Least square mean (LSM) difference|115.0|STANDARD_ERROR_OF_MEAN|144.0||0.4278|TWO_SIDED|90.0|-128.0|359.0||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||359|-128|0.4278
74029315|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|6.334||||0.089|TWO_SIDED|95.0|1.064|120.422||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||120.422|1.064|0.089
73927142|NCT03792672|147382126|SUPERIORITY||LSM difference|338.0|STANDARD_ERROR_OF_MEAN|147.0||0.0269|TWO_SIDED|90.0|90.5|585.0||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||585|90.5|0.0269
73927143|NCT03792672|147382127|SUPERIORITY||LSM difference|-0.388|STANDARD_ERROR_OF_MEAN|0.582||0.5089|TWO_SIDED|90.0|-1.37|0.595||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||0.595|-1.37|0.5089
73927144|NCT03792672|147382127|SUPERIORITY||LSM difference|-0.209|STANDARD_ERROR_OF_MEAN|0.581||0.7208|TWO_SIDED|90.0|-1.19|0.773||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||0.773|-1.19|0.7208
73927145|NCT03792672|147382128|SUPERIORITY||LSM difference|14.0|STANDARD_ERROR_OF_MEAN|17.1||0.4174|TWO_SIDED|90.0|-14.8|42.8||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 50 ms peak-to-peak amplitude||42.8|-14.8|0.4174
73927146|NCT03792672|147382128|SUPERIORITY||LSM difference|15.1|STANDARD_ERROR_OF_MEAN|17.1||0.3832|TWO_SIDED|90.0|-25.3|31.5||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 50 ms peak-to-peak amplitude||31.5|-25.3|0.3832
73927147|NCT03792672|147382128|SUPERIORITY||LSM difference|-0.326|STANDARD_ERROR_OF_MEAN|4.09||0.9368|TWO_SIDED|90.0|-7.23|6.58||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 100 ms peak-to-peak amplitude||6.58|-7.23|0.9368
73927148|NCT03792672|147382128|SUPERIORITY||LSM difference|3.71|STANDARD_ERROR_OF_MEAN|4.16||0.379|TWO_SIDED|90.0|-3.32|10.7||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 100 ms peak-to-peak amplitude||10.7|-3.32|0.3790
73927149|NCT03792672|147382128|SUPERIORITY||LSM difference|7.36|STANDARD_ERROR_OF_MEAN|6.41||0.258|TWO_SIDED|90.0|-3.44|18.2||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 200 ms peak-to-peak amplitude||18.2|-3.44|0.2580
73927150|NCT03792672|147382128|SUPERIORITY||LSM difference|9.36|STANDARD_ERROR_OF_MEAN|6.41||0.1524|TWO_SIDED|90.0|-1.45|20.2|||Mixed Models Analysis|||LICI 200 ms peak-to-peak amplitude||20.2|-1.45|0.1524
73927151|NCT03792672|147382128|SUPERIORITY||LSM difference|17.2|STANDARD_ERROR_OF_MEAN|7.21||0.022|TWO_SIDED|90.0|5.06|29.4||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 300 ms peak-to-peak amplitude||29.4|5.06|0.0220
73927152|NCT03792672|147382128|SUPERIORITY||LSM difference|9.58|STANDARD_ERROR_OF_MEAN|7.23||0.1927|TWO_SIDED|90.0|-2.59|21.8||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 300 ms peak-to-peak amplitude||21.8|-2.59|0.1927
73862656|NCT02564978|147271214|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.39|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.39
73927153|NCT03792672|147382129|SUPERIORITY||LSM difference|-5.65|STANDARD_ERROR_OF_MEAN|9.59||0.559|TWO_SIDED|90.0|-21.8|10.5||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||SICI 2 ms peak-to-peak amplitude||10.5|-21.8|0.5590
73927154|NCT03792672|147382129|SUPERIORITY||LSM difference|-16.1|STANDARD_ERROR_OF_MEAN|9.72||0.1049|TWO_SIDED|90.0|-32.5|0.242|||Mixed Models Analysis|||SICI 2 ms peak-to-peak amplitude||0.242|-32.5|0.1049
73927155|NCT03792672|147382129|SUPERIORITY||LSM difference|-16.7|STANDARD_ERROR_OF_MEAN|13.5||0.2238|TWO_SIDED|90.0|-39.4|6.06||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||SICI 5 ms peak-to-peak amplitude||6.06|-39.4|0.2238
73927156|NCT03792672|147382129|SUPERIORITY||LSM difference|-18.3|STANDARD_ERROR_OF_MEAN|13.6||0.1847|TWO_SIDED|90.0|-41.3|4.56|||Mixed Models Analysis|||SICI 5 ms peak-to-peak amplitude||4.56|-41.3|0.1847
73927157|NCT03583996|147382144|OTHER||Negative Likelihood Ratio (NLR)|0.293|||||TWO_SIDED|95.0|0.097|0.882||||||The performance goal for validation of DSI ≤18.3 was the upper limit of the confidence interval (CI) for negative likelihood ratio (NLR) to rule out an NLR of \>0.52. For the null and alternate hypotheses, the upper limit of the 95% CI was NLR \>0.52 and the upper limit of the 95% CI was NLR \<=0.52, respectively. The confidence level for the CI was adjusted to maintain a 1-sided type I error rate of 0.025.||0.882|0.097|
73927158|NCT03583996|147382144|OTHER||Sensitivity|0.917|||||TWO_SIDED|95.0|0.775|0.982||||||The performance goal for validation of DSI \<= 18.3 was the observed sensitivity must have been \>0.85. The confidence level for the confidence interval (CI) was adjusted to maintain a 1-sided type I error rate of 0.025.||0.982|0.775|
73927159|NCT03583996|147382145|OTHER||Odds Ratio (OR)|1.094|||<|0.0001|TWO_SIDED|95.0|1.047|1.143||The odds ratio was for a 1-unit increase in DSI based on continuous DSI.|Regression, Logistic|Unadjusted (no covariates)||||1.143|1.047|<0.0001
73927160|NCT03583996|147382145|OTHER||Odds Ratio (OR)|1.109|||<|0.0001|TWO_SIDED|95.0|1.058|1.163|||Regression, Logistic|Adjusted for demographic covariates, including age, race, sex, BMI, and ethnicity.||||1.163|1.058|<0.0001
73927161|NCT03583996|147382145|OTHER||Odds Ratio (OR)|1.092|||<|0.001|TWO_SIDED|95.0|1.041|1.145|||Regression, Logistic|Adjusted for severity of liver disease covariates, compensated cirrhosis (CP class A)||||1.145|1.041|<0.001
73927162|NCT03583996|147382145|OTHER||Odds Ratio (OR)|1.089|||<|0.001|TWO_SIDED|95.0|1.038|1.142|||Regression, Logistic|Adjusted for severity of liver disease covariates, decompensated cirrhosis (CP class B)||||1.142|1.038|<0.001
73927163|NCT04534764|147382146|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least Square Mean Difference|-0.016|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.039|0.006|||Mixed Models Analysis||LS Mean difference was calculated as Test - Control.|High Luminance Low Contrast||0.006|-0.039|
73927164|NCT04534764|147382146|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least Square Mean Difference|0.009|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.014|0.031|||Mixed Models Analysis||LS Mean difference was calculated as Test - Control.|Low Luminance High Contrast||0.031|-0.014|
73927165|NCT03161483|147382147|SUPERIORITY||Stratified difference|11.4||||0.214|TWO_SIDED|95.0|-6.57|29.0|||Cochran-Mantel-Haenszel|||||29.00|-6.57|0.214
73927166|NCT03161483|147382147|SUPERIORITY||Stratified difference|5.0||||0.512|TWO_SIDED|95.0|-9.77|19.48|||Cochran-Mantel-Haenszel|||||19.48|-9.77|0.512
73927167|NCT03161483|147382147|SUPERIORITY||Stratified difference|19.4||||0.011|TWO_SIDED|95.0|4.12|33.42|||Cochran-Mantel-Haenszel|||||33.42|4.12|0.011
73927168|NCT03161483|147382148|SUPERIORITY||Stratified difference|10.3||||0.264|TWO_SIDED|95.0|-7.66|27.97|||Cochran-Mantel-Haenszel|||||27.97|-7.66|0.264
73927169|NCT03161483|147382148|SUPERIORITY||Stratified difference|6.5||||0.399|TWO_SIDED|95.0|-8.45|21.0|||Cochran-Mantel-Haenszel|||||21.00|-8.45|0.399
73927170|NCT03161483|147382148|SUPERIORITY||Stratified difference|19.3||||0.012|TWO_SIDED|95.0|4.01|33.36|||Cochran-Mantel-Haenszel|||||33.36|4.01|0.012
73927171|NCT03161483|147382149|SUPERIORITY||Stratified difference|24.0||||0.446|TWO_SIDED|95.0|-12.38|53.11|||Cochran-Mantel-Haenszel|||||53.11|-12.38|0.446
73927172|NCT03161483|147382149|SUPERIORITY||Stratified difference|5.3|||>|0.999|TWO_SIDED|95.0|-27.64|39.38|||Cochran-Mantel-Haenszel|||||39.38|-27.64|>0.999
73927173|NCT03161483|147382149|SUPERIORITY||Stratified difference|14.2||||0.488|TWO_SIDED|95.0|-19.54|44.48|||Cochran-Mantel-Haenszel|||||44.48|-19.54|0.488
73969567|NCT06424236|147478914|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.034||0.188|TWO_SIDED|95.0|-0.02|0.11|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.11|-0.02|0.188
73969568|NCT06424236|147478915|OTHER||LS mean|0.0067|STANDARD_DEVIATION|0.0124||0.0001|TWO_SIDED|95.0|0.0034|0.01|||MMRM|||Week 52: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0100|0.0034|0.0001
73927174|NCT03161483|147382150|SUPERIORITY||Stratified difference|12.4||||0.092|TWO_SIDED|95.0|-2.74|24.07|||Cochran-Mantel-Haenszel|||||24.07|-2.74|0.092
73927175|NCT03161483|147382150|SUPERIORITY||Stratified difference|-5.3||||0.434|TWO_SIDED|95.0|-18.43|8.06|||Cochran-Mantel-Haenszel|||||8.06|-18.43|0.434
73927176|NCT03161483|147382150|SUPERIORITY||Stratified difference|8.0||||0.182|TWO_SIDED|95.0|-3.88|19.65|||Cochran-Mantel-Haenszel|||||19.65|-3.88|0.182
73927177|NCT03161483|147382151|SUPERIORITY||Stratified difference|12.1||||0.098|TWO_SIDED|95.0|-2.98|23.78|||Cochran-Mantel-Haenszel|||||23.78|-2.98|0.098
73927178|NCT03161483|147382151|SUPERIORITY||Stratified difference|-4.3||||0.521|TWO_SIDED|95.0|-17.36|8.92|||Cochran-Mantel-Haenszel|||||8.92|-17.36|0.521
73927179|NCT03161483|147382151|SUPERIORITY||Stratified difference|6.8||||0.267|TWO_SIDED|95.0|-5.24|18.55|||Cochran-Mantel-Haenszel|||||18.55|-5.24|0.267
73969569|NCT06424236|147478915|OTHER||LS mean|0.0251|STANDARD_DEVIATION|0.02262|<|0.0001|TWO_SIDED|95.0|0.0189|0.0312|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0312|0.0189|<0.0001
73969570|NCT06424236|147478915|OTHER||LS mean|0.0357|STANDARD_DEVIATION|0.02467|<|0.0001|TWO_SIDED|95.0|0.0266|0.0447|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0447|0.0266|<0.0001
73969571|NCT06424236|147478916|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.081||0.644|TWO_SIDED|95.0|-0.12|0.2|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.20|-0.12|0.644
73969572|NCT06424236|147478916|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.111||0.745|TWO_SIDED|95.0|-0.18|0.26|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.26|-0.18|0.745
73969573|NCT04213872|147478917|OTHER|||||||0.01|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCI 25.4 (14.2) 17.3 (10.5) \*-8.1 (3.7) .01~\*reduction in scores indicate improvement."||||.01
73969574|NCT04213872|147478918|OTHER|||||||0.03|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCA 16.0 (5.1) 19.2 (5.3) 3.2 (0.2) .03||||.03
73969575|NCT04213872|147478919|OTHER|||||||0.04|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogQOL 3.7 (3.8) 1.8 (2.2) \*-1.9 (1.6) .04~\*lower scores signifying better outcomes."||||.04
73969576|NCT04213872|147478920|OTHER|||||||0.04|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogOth 1.5 (2.1) 0.2 (0.4) \*-1.3 (1.7) .04~\*lower scores signifying better outcomes."||||.04
74087933|NCT03440424|147729756|OTHER||Percent ratio of geometric mean|105.2|||||TWO_SIDED|90.0|77.89|142.08|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||142.08|77.89|
73927180|NCT03161483|147382152|SUPERIORITY||Difference in adjusted mean|0.7||||0.116|TWO_SIDED|95.0|-0.2|1.5|||longitudinal data analysis model|||||1.5|-0.2|0.116
73969577|NCT04213872|147478921|OTHER|||||||0.01|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value WAIS-III Letter/Number 10.7 (3.2) 12.7 (2.8) 2.0 (0.4) .01||||.01
74087934|NCT03440424|147729757|OTHER||Percent ratio of geometric mean|115.38|||||TWO_SIDED|90.0|83.51|159.42|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||159.42|83.51|
73927181|NCT03161483|147382152|SUPERIORITY||Difference in adjusted mean|0.7||||0.094|TWO_SIDED|95.0|-0.1|1.6|||longitudinal data analysis model|||||1.6|-0.1|0.094
73927182|NCT03161483|147382152|SUPERIORITY||Difference in adjusted mean|0.1||||0.881|TWO_SIDED|95.0|-0.6|0.8|||longitudinal data analysis model|||||0.8|-0.6|0.881
73927183|NCT03161483|147382153|SUPERIORITY||Difference in adjusted mean|1.1||||0.16|TWO_SIDED|95.0|-0.4|2.6|||longitudinal data analysis model|||||2.6|-0.4|0.160
73927184|NCT03161483|147382153|SUPERIORITY||Difference in adjusted mean|1.3||||0.056|TWO_SIDED|95.0|0.0|2.6|||longitudinal data analysis model|||||2.6|0.0|0.056
73927185|NCT03161483|147382153|SUPERIORITY||Difference in adjusted mean|0.3||||0.621|TWO_SIDED|95.0|-1.0|1.6|||longitudinal data analysis model|||||1.6|-1.0|0.621
73927186|NCT03161483|147382155|SUPERIORITY||Difference in adjusted mean|-1.1||||0.546|TWO_SIDED|95.0|-4.7|2.5|||longitudinal data analysis model|||||2.5|-4.7|0.546
73969578|NCT04213872|147478922|OTHER|||||||0.6|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value~WAIS-III Digit Span Forward and Backward 19.2 (4.8) 19.7 (4.4) 0.5 (0.4) .60"||||.60
73969579|NCT04213872|147478923|OTHER|||||||0.03|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value PSQI 1.5 (0.8) 0.9 (0.7) \*-0.6 (0.1) .03~\*Lower scores mean better outcomes."||||.03
73969580|NCT04213872|147478924|OTHER|||||||0.05|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Anxiety 9.2 (7.7) 4.2 (3.7) \*-5.0 (4.0) .05~\*Lower scores mean better outcomes."||||.05
73969581|NCT04213872|147478925|OTHER|||||||0.08|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Depression 4.1 (4.9) 2.0 (3.0) \*-2.1 (1.9) .08~\*Lower scores mean better outcomes."||||.08
74087935|NCT03440424|147729757|OTHER||Percent ratio of geometric mean|116.97|||||TWO_SIDED|90.0|84.66|161.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||161.62|84.66|
73927187|NCT03161483|147382155|SUPERIORITY||Difference in adjusted mean|-0.6||||0.681|TWO_SIDED|95.0|-3.7|2.4|||longitudinal data analysis model|||||2.4|-3.7|0.681
73927188|NCT03161483|147382155|SUPERIORITY||Difference in adjusted mean|1.4||||0.35|TWO_SIDED|95.0|-1.6|4.4|||longitudinal data analysis model|||||4.4|-1.6|0.350
74087936|NCT03440424|147729757|OTHER||Percent ratio of geometric mean|78.46|||||TWO_SIDED|90.0|61.06|100.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||100.81|61.06|
74087937|NCT03440424|147729757|OTHER||Percent ratio of geometric mean|116.76|||||TWO_SIDED|90.0|89.95|151.56|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||151.56|89.95|
74087938|NCT03440424|147729757|OTHER||Percent ratio of geometric mean|94.97|||||TWO_SIDED|90.0|70.31|128.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||128.28|70.31|
74087939|NCT03440424|147729757|OTHER||Percent ratio of geometric mean|103.59|||||TWO_SIDED|90.0|75.43|142.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||142.28|75.43|
74087940|NCT03702049|147729765|OTHER|Change in score at 3 months|Mean Difference (Final Values)|-0.24||||0.603|TWO_SIDED||||||Mixed Models Analysis|||Change in score at 3 months||||0.603
73927189|NCT03161483|147382156|SUPERIORITY|\<= 7.5 mg/day|Stratified difference|0.2|||>|0.999|TWO_SIDED|95.0|-15.13|15.91|||longitudinal data analysis model|||||15.91|-15.13|>0.999
73927190|NCT03161483|147382156|SUPERIORITY|\< 10 mg/day|Stratified difference|-3.2|||>|0.999|TWO_SIDED|95.0|-17.74|13.0|||longitudinal data analysis model|||||13.00|-17.74|>0.999
73927191|NCT03161483|147382157|SUPERIORITY||Difference in adjusted means|2.8||||0.535|TWO_SIDED|95.0|-6.0|11.6|||longitudinal data analysis model|||||11.6|-6.0|0.535
73927192|NCT03161483|147382157|SUPERIORITY||Difference in adjusted means|4.2||||0.309|TWO_SIDED|95.0|-3.9|12.2|||longitudinal data analysis model|||||12.2|-3.9|0.309
73927193|NCT03161483|147382157|SUPERIORITY||Difference in adjusted means|6.5||||0.091|TWO_SIDED|95.0|-1.0|14.1|||longitudinal data analysis model|||||14.1|-1.0|0.091
73927194|NCT02767427|147382160|EQUIVALENCE|An equivalence test on data from a parallel-group design with sample sizes of 18 in the reference group and 18 in the treatment group achieves 80% power. The significance was set at 5%. The standard deviation was 1.00, and the equivalence limits were set at -1.00 and 1.00.|||||<|0.05|||||||t-test, 1 sided|Two one-sided t-tests were conducted with 18 in each group.||||||<0.05
73927195|NCT05389657|147382187|SUPERIORITY||Odds Ratio (OR)|0.617||||0.47|TWO_SIDED|95.0|0.167|2.283|||Regression, Logistic|multilevel logistic regression||We used logistic multilevel models to examine the impact of training assignment (reference = live training) on training completion, with a random intercept at the agency level. Covariates included prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||2.283|0.167|0.47
73927196|NCT05389657|147382188|SUPERIORITY||adjusted group difference unstandardized|-1.268||||0.29|TWO_SIDED|95.0|-3.618|1.083|||Regression, Linear|multilevel linear regression with restricted maximum likelihood (REML) estimation||We used linear multilevel models with restricted maximum likelihood (REML) estimation to examine the impact of training assignment (reference = live training) on knowledge acquisition at post-training, with a random intercept at the agency level. Covariates included baseline FBT-KA score, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||1.083|-3.618|.29
74087941|NCT03702049|147729765|OTHER|Change at 6 months|Mean Difference (Final Values)|-0.12||||0.805|TWO_SIDED||||||Mixed Models Analysis|||6 month outcome||||0.805
74087942|NCT03702049|147729766|OTHER||Odds Ratio (OR)|0.83||||0.672|TWO_SIDED|95.0|0.39|1.79|||Regression, Logistic|||3 month outcome||1.79|0.39|0.672
74087943|NCT03702049|147729766|OTHER||Odds Ratio (OR)|0.49||||0.165|TWO_SIDED|95.0|0.18|1.34|||Regression, Logistic|||6 month outcome||1.34|0.18|0.165
74087944|NCT03702049|147729767|OTHER||Mean Difference (Final Values)|-0.31||||0.719|TWO_SIDED||||||Mixed Models Analysis|||3 month outcome||||0.719
74087945|NCT03702049|147729767|OTHER||Mean Difference (Final Values)|0.43||||0.626|TWO_SIDED||||||Mixed Models Analysis|||6 month outcome||||0.626
74087946|NCT03702049|147729768|OTHER||Mean Difference (Final Values)|0.83||||0.1668|TWO_SIDED|95.0|-0.36|2.03|||t-test, 2 sided|||||2.03|-0.36|0.1668
74087947|NCT03702049|147729769|OTHER||Mean Difference (Final Values)|1.5||||0.9198|TWO_SIDED|95.0|-29.6|32.7|||t-test, 2 sided|||3 month outcome||32.7|-29.6|0.9198
74087948|NCT03702049|147729769|OTHER||Mean Difference (Final Values)|12.5||||0.5015|TWO_SIDED|95.0|-25.6|50.7|||t-test, 2 sided|||6 month||50.7|-25.6|0.5015
74087949|NCT01715896|147729770|SUPERIORITY_OR_OTHER||Percent difference|-3.5||||0.666|TWO_SIDED|90.0|-16.8|9.8|||Logit response Model||P-value and 90% unconditional exact confidence interval (CI) was calculated using the model of logit (response) = strata + treatment.|||9.8|-16.8|0.666
74087950|NCT01715896|147729771|SUPERIORITY_OR_OTHER||Percent difference|-8.6||||0.293|TWO_SIDED|90.0|-22.0|4.8|||Logit response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||4.8|-22.0|0.293
74087951|NCT01715896|147729772|SUPERIORITY_OR_OTHER||Percent difference|-9.8||||0.156|TWO_SIDED|90.0|-21.1|1.4|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||1.4|-21.1|0.156
74087952|NCT01715896|147729773|SUPERIORITY_OR_OTHER||Percent difference|-11.6||||0.108|TWO_SIDED|90.0|-23.2|0.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||0.0|-23.2|0.108
74087953|NCT01715896|147729774|SUPERIORITY_OR_OTHER||Percent difference|-10.3||||0.208|TWO_SIDED|90.0|-23.7|3.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||3.0|-23.7|0.2080
73927197|NCT05389657|147382189|SUPERIORITY||Odds Ratio (OR)|1.16||||0.92|TWO_SIDED|95.0|0.07|19.293|||Regression, Logistic|multilevel logistic regression||We used logistic multilevel models to examine the impact of training assignment (reference = live training) on engagement in FBT consultation at 12 months, with a random intercept at the agency level. Covariates included baseline intent to seek FBT consultation, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||19.293|0.070|0.92
73969582|NCT04213872|147478926|OTHER|||||||0.3|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value BDNF 0.11 (0.9) 0.30 (0.7) 0.19 (0.2) .30~Higher scores mean better outcomes."||||.30
73969583|NCT04213872|147478927|OTHER|||||||0.8|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value NF-kB1 171.7 (25.4) 173.7 (21.6) 2.0 (3.8) .80~Higher scores mean better outcomes."||||.80
74029316|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|5.026||||0.143|TWO_SIDED|95.0|0.797|96.916||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||96.916|0.797|0.143
73969584|NCT04213872|147478928|OTHER|||||||0.61|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value TP53 12.3 (2.7) 13.1 (5.5) 0.8 (2.8) .61||||.61
73969585|NCT03339713|147478929|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.55|1.11|||t-test, 1 sided|||A/Michigan strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.11|0.55|<.001
73969586|NCT03339713|147478929|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.59|1.12|||t-test, 1 sided|||A/Hong Kong strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.12|0.59|<.001
73969587|NCT03339713|147478929|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|1.0|||<|0.001|TWO_SIDED|90.0|0.77|1.34|||t-test, 1 sided|||B/Brisbane strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.34|0.77|<.001
73969588|NCT03339713|147478929|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|1.0|||<|0.001|TWO_SIDED|90.0|0.76|1.36|||t-test, 1 sided|||B/Phuket strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.36|0.76|<.001
73969589|NCT01715285|147478965|SUPERIORITY||Hazard Ratio (HR)|0.466|||<|0.0001|TWO_SIDED|95.0|0.394|0.55|||Log Rank|||||0.550|0.394|<0.0001
73969590|NCT01715285|147478966|SUPERIORITY||Hazard Ratio (HR)|0.661|||<|0.0001|TWO_SIDED|95.0|0.564|0.775|||Log Rank|||||0.775|0.564|< 0.0001
73969591|NCT05505292|147478972|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
74029317|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|1.257||||0.711|TWO_SIDED|95.0|0.37|4.468||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.468|0.370|0.711
73969592|NCT05505292|147478973|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
73969593|NCT05505292|147478974|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
73969594|NCT05505292|147478975|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
73969595|NCT05505292|147478976|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
74087954|NCT01715896|147729781|SUPERIORITY_OR_OTHER||Adjusted Mean difference|-7.42||||0.213|TWO_SIDED|90.0|-17.24|2.4|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term.|||2.40|-17.24|0.213
74087955|NCT01715896|147729783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.129|TWO_SIDED|90.0|0.36|1.04|||Proportional odds analysis||Odds ratio, 90% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor.|||1.04|0.36|0.129
74087956|NCT01715896|147729784|SUPERIORITY_OR_OTHER||Percent difference|-11.6||||0.108||90.0|-23.2|0.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.||0.0|-23.2|0.108
74087957|NCT01715896|147729784|SUPERIORITY_OR_OTHER||Percent difference|-11.7||||0.145|TWO_SIDED|90.0|-24.8|1.4|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|The analysis reported DAS28 (CRP) low disease activity response.||1.4|-24.8|0.145
74087958|NCT01715896|147729785|SUPERIORITY_OR_OTHER|||||||0.328|||||||Log Rank|P-value was calculated using the Log rank test.||||||0.328
74087959|NCT01715896|147729786|SUPERIORITY_OR_OTHER|||||||0.003|||||||Weibull model|P-value was calculated using an Weibull model.||||||0.003
74087960|NCT01715896|147729787|SUPERIORITY_OR_OTHER||Percent difference|-1.7||||0.795|TWO_SIDED|90.0|-12.4|9.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|P-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.||9.0|-12.4|0.795
74087961|NCT01715896|147729788|SUPERIORITY_OR_OTHER||Percent difference|-11.7||||0.048|TWO_SIDED|90.0|-21.0|-2.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-2.5|-21.0|0.048
74087962|NCT01715896|147729789|SUPERIORITY_OR_OTHER||Percent difference|-11.9||||0.035|TWO_SIDED|90.0|-20.6|-3.1|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-3.1|-20.6|0.035
74087963|NCT01715896|147729790|SUPERIORITY_OR_OTHER||Percent difference|-7.5||||0.061|TWO_SIDED|90.0|-13.6|-1.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-1.5|-13.6|0.061
74087964|NCT01715896|147729791|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01||||0.993|TWO_SIDED|90.0|-1.33|1.32|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in swollen joint count at Day 169.||1.32|-1.33|0.993
74087965|NCT01715896|147729791|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.23||||0.424|TWO_SIDED|90.0|-1.31|3.77|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in Tender joint count at Day 169.||3.77|-1.31|0.424
73927198|NCT01907828|147382190|OTHER|||||||0.22|||||||Log Rank|||Kaplan-Meier analysis performed to provide freedom from atrial fibrillation rates at one year for each randomization arm using date of ablation procedure to date of first event.||||0.22
73927199|NCT01907828|147382194|SUPERIORITY|||||||0.2766|||||||Paired Student's t-test|||||||0.2766
73927200|NCT01907828|147382195|SUPERIORITY|||||||0.7663|||||||Wilcoxon signed-rank test|||||||0.7663
73969596|NCT05505292|147478977|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
73927201|NCT01907828|147382198|SUPERIORITY||Mean Difference (Final Values)|-5.86|STANDARD_DEVIATION|15.21||0.0849|TWO_SIDED|95.0|-12.61|0.88|||Paired Student's t-test|||Change in ASBP at 12 months||0.88|-12.61|0.0849
73927202|NCT01907828|147382198|SUPERIORITY||Mean Difference (Final Values)|-5.82|STANDARD_DEVIATION|7.45||0.0014|TWO_SIDED|95.0|-9.12|-2.52|||Paired Student's t-test|||Change in ADBP at 12 months||-2.52|-9.12|0.0014
73927203|NCT01907828|147382198|SUPERIORITY||Mean Difference (Final Values)|-3.07|STANDARD_DEVIATION|19.21||0.5599|TWO_SIDED|95.0|-14.16|8.02|||Paired Student's t-test|||Change in ASBP at 12 months.||8.02|-14.16|0.5599
74087966|NCT01715896|147729792|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.89||||0.272|TWO_SIDED|90.0|-2.46|12.24|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||12.24|-2.46|0.272
74087967|NCT01715896|147729793|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.46||||0.319|TWO_SIDED|90.0|-2.92|11.84|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||11.84|-2.92|0.319
74087968|NCT01715896|147729794|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.16||||0.64|TWO_SIDED|90.0|-0.42|0.74|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||0.74|-0.42|0.640
74087969|NCT01715896|147729795|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.18||||0.055|TWO_SIDED|90.0|0.03|0.34|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||0.34|0.03|0.055
74087970|NCT01715896|147729796|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.06||||0.752|TWO_SIDED|90.0|0.79|1.41|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.|||1.41|0.79|0.752
74087971|NCT01715896|147729797|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.05||||0.725|TWO_SIDED|90.0|0.84|1.3|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.|||1.30|0.84|0.725
74087972|NCT05212883|147729806|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||Comparison of the likelihood to test before gathering for age \< 18 vs. age \>= 18.||1.3|0.8|
73927204|NCT01907828|147382198|SUPERIORITY||Mean Difference (Final Values)|-8.43|STANDARD_DEVIATION|9.42||0.0052|TWO_SIDED|95.0|-13.87|-2.99|||Paired Student's t-test|||Change in ADBP at 12 months||-2.99|-13.87|0.0052
73927205|NCT01907828|147382199|SUPERIORITY||Mean Difference (Final Values)|-5.71|STANDARD_DEVIATION|14.84||0.1326|TWO_SIDED|95.0|-13.34|1.93|||Paired Student's t-test|||Change in ASBP at 24 months||1.93|-13.34|0.1326
73969597|NCT05505292|147478978|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Question 1a Change from baseline to week 8 in lifitegrast vs vehicle||||0.62
73927206|NCT01907828|147382199|SUPERIORITY||Mean Difference (Final Values)|-6.94|STANDARD_DEVIATION|6.06||0.0002|TWO_SIDED|95.0|-10.06|-3.83|||Paired Student's t-test|||Change in ADBP at 24 months||-3.83|-10.06|0.0002
73927207|NCT01907828|147382199|SUPERIORITY||Mean Difference (Final Values)|-8.58|STANDARD_DEVIATION|12.41||0.0354|TWO_SIDED|95.0|-16.47|-0.7|||Paired Student's t-test|||Change in ASBP at 24 months||-0.70|-16.47|0.0354
73927208|NCT01907828|147382199|SUPERIORITY||Mean Difference (Final Values)|-10.33|STANDARD_DEVIATION|8.53||0.0015|TWO_SIDED|95.0|-15.75|-4.91|||Paired Student's t-test|||Change in ADBP at 24 months||-4.91|-15.75|0.0015
73927209|NCT01907828|147382200|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|24.4||0.5399|TWO_SIDED|95.0|-6.0|11.3|||Paired Student's t-test|||Change in OSBP at 12 months.||11.3|-6.0|0.5399
73927210|NCT01907828|147382200|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|11.8||0.8489|TWO_SIDED|95.0|-4.6|3.8|||Paired Student's t-test|||Change in Office Diastolic Blood Pressure (ODBP) at 12 months||3.8|-4.6|0.8489
73927211|NCT01907828|147382200|SUPERIORITY|Change in Office Systolic Blood Pressure (OSBP) at 12 months.|Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|30.0||0.7999|TWO_SIDED|95.0|-14.6|18.6|||Paired Student's t-test|||||18.6|-14.6|0.7999
73927212|NCT01907828|147382200|SUPERIORITY||Mean Difference (Final Values)|-5.4|STANDARD_DEVIATION|15.8||0.2076|TWO_SIDED|95.0|-14.2|3.4|||Paired Student's t-test|||Change in ODBP at 12 months||3.4|-14.2|0.2076
73927213|NCT01907828|147382201|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|22.3||0.882|TWO_SIDED|95.0|-7.9|9.1|||Paired Student's t-test|||Change in OSBP at 24 months||9.1|-7.9|0.8820
73927214|NCT01907828|147382201|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|11.0||0.8019|TWO_SIDED|95.0|-3.7|4.7|||Paired Student's t-test|||Change in ODBP at 24 months||4.7|-3.7|0.8019
73969598|NCT05505292|147478978|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Question 1b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.53
73927215|NCT01907828|147382201|SUPERIORITY||Mean Difference (Final Values)|7.4|STANDARD_DEVIATION|22.9||0.2177|TWO_SIDED|95.0|-4.8|19.6|||Paired Student's t-test|||Change in OSBP at 24 months||19.6|-4.8|0.2177
73927216|NCT01907828|147382201|SUPERIORITY||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|15.5||0.4502|TWO_SIDED|95.0|-11.2|5.2|||Paired Student's t-test|||Change in ODBP at 24 months||5.2|-11.2|0.4502
73927217|NCT01073865|147382209|NON_INFERIORITY_OR_EQUIVALENCE|The lower limit of the CI of the difference is greater than or equal to -17.5%. This non-inferiority margin was pre-defined in the study protocol.|Risk Difference (RD)|1.29|||||TWO_SIDED|95.0|-11.4|13.9|||||%PFS at 24 weeks for Zoladex 10.8mg - %PFS at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in %PFS at 24 weeks calculated using the score method recommended by Newcombe et al||13.90|-11.40|
73927218|NCT01073865|147382210|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.02|||||TWO_SIDED|95.0|-15.47|9.67|||||ORR at 24 weeks for Zoladex 10.8mg - ORR at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in ORR at 24 weeks calculated using the score method recommended by Newcombe et al||9.67|-15.47|
73927219|NCT03917420|147382247|OTHER|Correlation|Spearman's Rho|-0.455|||||TWO_SIDED|||||||||||||
73927220|NCT03917420|147382248|OTHER|Correlation|Spearman's Rho|0.152|||||TWO_SIDED|||||||||||||
73927221|NCT03917420|147382249|OTHER|Correlation|Spearman's Rho|0.564|||||TWO_SIDED|||||||||||||
73927222|NCT03917420|147382250|OTHER|Correlation|Spearman's Rho|0.285|||||TWO_SIDED|||||||||||||
73927223|NCT03373383|147382266|SUPERIORITY||Percent reduction|17.2|||=|0.102|TWO_SIDED|95.0|-3.8|33.9||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||33.9|-3.8|=0.102
73927224|NCT03373383|147382266|SUPERIORITY||Percent reduction|19.1|||=|0.064|TWO_SIDED|95.0|-1.2|35.4||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||35.4|-1.2|=0.064
73927225|NCT03373383|147382266|SUPERIORITY||Percent reduction|19.2|||=|0.063|TWO_SIDED|95.0|-1.2|35.5||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||35.5|-1.2|=0.063
73927226|NCT03373383|147382266|SUPERIORITY||Percent reduction|12.4|||=|0.248|TWO_SIDED|95.0|-9.7|30.1||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp\[diff\]), where diff was the model estimate of the log ratio between each PSL group and placebo group.||30.1|-9.7|=0.248
73927227|NCT03373383|147382267|SUPERIORITY||Odds Ratio (OR)|2.72|||=|0.081|TWO_SIDED|95.0|0.88|8.39||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||8.39|0.88|=0.081
73969599|NCT05505292|147478978|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Question 2a change from baseline to week 8 in lifitegrast vs vehicle groups||||0.66
73969600|NCT05505292|147478978|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Question 2b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.81
73862657|NCT02564978|147271215|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.48|TWO_SIDED|95.0|-0.06|0.03||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.03|-0.06|0.48
73862658|NCT02564978|147271215|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.15|TWO_SIDED|95.0|-0.24|0.04||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.04|-0.24|0.15
73862659|NCT02564978|147271215|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.15|TWO_SIDED|95.0|-0.09|0.01||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes (Study eye + QFE) together. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.01|-0.09|0.15
73927228|NCT03373383|147382267|SUPERIORITY||Odds Ratio (OR)|2.37|||=|0.137|TWO_SIDED|95.0|0.76|7.41||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||7.41|0.76|=0.137
73927229|NCT03373383|147382267|SUPERIORITY||Odds Ratio (OR)|2.16|||=|0.192|TWO_SIDED|95.0|0.68|6.89||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||6.89|0.68|=0.192
73927230|NCT03373383|147382267|SUPERIORITY||Odds Ratio (OR)|3.14|||=|0.041|TWO_SIDED|95.0|1.05|9.42||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||9.42|1.05|=0.041
73927231|NCT03373383|147382271|SUPERIORITY||Odds Ratio (OR)|2.09|||=|0.045|TWO_SIDED|95.0|1.02|4.3||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||4.30|1.02|=0.045
73927232|NCT03373383|147382271|SUPERIORITY||Odds Ratio (OR)|1.91|||=|0.079|TWO_SIDED|95.0|0.93|3.93||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.93|0.93|=0.079
73927233|NCT03373383|147382271|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.338|TWO_SIDED|95.0|0.68|3.02||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.02|0.68|=0.338
73927234|NCT03373383|147382271|SUPERIORITY||Odds Ratio (OR)|1.88|||=|0.087|TWO_SIDED|95.0|0.91|3.87||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.87|0.91|=0.087
73927235|NCT03373383|147382272|OTHER||Median Difference (Net)|7.4|||=|0.316|TWO_SIDED|95.0|-6.59|21.89||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||21.89|-6.59|=0.316
73927236|NCT03373383|147382272|OTHER||Median Difference (Net)|9.99|||=|0.133|TWO_SIDED|95.0|-3.15|23.26||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||23.26|-3.15|=0.133
73927237|NCT03373383|147382272|OTHER||Median Difference (Net)|8.19|||=|0.203|TWO_SIDED|95.0|-3.95|21.37||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||21.37|-3.95|=0.203
73969601|NCT05505292|147478978|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Question 3a change from baseline to week 8 in lifitegrast vs vehicle groups||||>0.999
73927238|NCT03373383|147382272|OTHER||Median Difference (Net)|2.39|||=|0.784|TWO_SIDED|95.0|-13.65|17.79||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||17.79|-13.65|=0.784
73927239|NCT02907359|147382301|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6063|TWO_SIDED|95.0|0.74|1.19||OS between Guadecitabine vs Treatment Choice using stratified log-rank test. Due to pre-specified hierarchical testing plan, other endpoints were not evaluated for statistical significance.|Stratified Log-rank test|||||1.19|0.74|0.6063
73927240|NCT02739269|147382315|SUPERIORITY|||||||0.479|||||||Chi-squared|||||||0.479
73927241|NCT02739269|147382316|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
73927242|NCT00923559|147382317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.69|STANDARD_ERROR_OF_MEAN|3.04||0.006||95.0|2.64|14.74||Null hypothesis MIP and CHC care should yield equal outcomes. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom (df) = 68.3||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||14.74|2.64|.006
73927243|NCT00923559|147382318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.57|STANDARD_ERROR_OF_MEAN|1.06||0.018|TWO_SIDED|95.0|0.46|4.68||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom (df) = 69.3||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||4.68|0.46|.018
73927244|NCT00923559|147382319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.24||0.266|TWO_SIDED|95.0|-0.21|0.75||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom = 73.4||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.75|-0.21|.266
73927245|NCT00923559|147382320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.052|TWO_SIDED|95.0|0.0|0.32||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.32|0.00|.052
73927246|NCT00923559|147382321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|0.38||0.031|TWO_SIDED|95.0|-1.61|-0.08|||Regression, Linear|Degrees of freedom (df) = 61.2||see under the PIR-GAS||-0.08|-1.61|.031
73927247|NCT00923559|147382322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.158|TWO_SIDED|95.0|-0.05|0.31|||Mixed Models Analysis|Degrees of freedom (df) = 71.2||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.31|-0.05|.158
73927248|NCT01951157|147382323|SUPERIORITY||The exact binomial estimator|29.2|||||TWO_SIDED|95.0|13.2|48.4||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed.||48.4|13.2|
73927249|NCT01951157|147382323|SUPERIORITY||The exact binomial estimator|19.0|||||TWO_SIDED|95.0|5.7|37.9||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed||37.9|5.7|
73927250|NCT01951157|147382323|SUPERIORITY||The exact binomial estimator|28.0|||||TWO_SIDED|95.0|12.6|46.7||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed||46.7|12.6|
73927251|NCT01951157|147382324|SUPERIORITY|Pre-specified|||||=|0.3873|||||||Log Rank|||||||= 0.3873
73927252|NCT01951157|147382328|SUPERIORITY|Pre-specified|||||=|0.0177|||||||Log Rank|||||||= 0.0177
73927253|NCT01951157|147382329|SUPERIORITY_OR_OTHER_LEGACY|Pre-specified||||||0.3526|||||||Log Rank|||||||0.3526
73927254|NCT01951157|147382330|SUPERIORITY|Pre-specified||||||0.9026|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.||||0.9026
73927255|NCT01951157|147382330|SUPERIORITY|||||||0.9862|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.||||0.9862
73927256|NCT01951157|147382330|SUPERIORITY|||||||0.8057|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of ilcoxon signed ranks test repeat-measure analyses of variance.||||0.8057
73927257|NCT05218018|147382331|OTHER|||||||0.002|||||||t-test, 2 sided|||||||.002
73927258|NCT00329407|147382335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-6.58|-3.14|||Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This was a within subject analysis. The null hypothesis was that there would be no significant difference in least squares means values obtained for the baseline and week 10 assessment weeks.||-3.14|-6.58|<0.0001
73927259|NCT00329407|147382336|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0|STANDARD_ERROR_OF_MEAN|2.7||0.001|ONE_SIDED|95.0||||There would a significant reduction in COWAT scores between baseline and Week 10.|Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This is a within subject comparison of COWAT scores botained for the baseline session and the Week 10 session. The null hypothesis is that there would be no difference between these scores.||||0.001
73927260|NCT00978068|147382337|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.59||||0.04|TWO_SIDED|95.0|0.36|0.97|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.||0.97|0.36|0.04
73927261|NCT00978068|147382338|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Cox Proportional-Hazards|||||||0.13
73927262|NCT00978068|147382339|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.8||||0.87|TWO_SIDED|95.0|0.06|11.16|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.||11.16|0.06|0.87
73927263|NCT00978068|147382340|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.14|TWO_SIDED|95.0|0.45|1.12|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.|||1.12|0.45|0.14
73927264|NCT00978068|147382341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.004|TWO_SIDED|95.0|0.14|0.68|||Cox Proportional-Hazards|Adjustment for repeated measures in same participant.|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.|||0.68|0.14|0.004
73927265|NCT00978068|147382342|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.004|TWO_SIDED|95.0|0.22|0.76|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient.|Group 1 represents the numerator in the hazard ratio. Group 2 represents the denominator in the hazard ratio.|||0.76|0.22|0.004
73927266|NCT02120794|147382364|NON_INFERIORITY|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.125|0.395||||||||0.395|0.125|
73862660|NCT02564978|147271216|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.61|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.61
73927267|NCT01644175|147382373|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.9|||<|0.0001|TWO_SIDED|95.0|-52.5|-39.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-39.3|-52.5|<0.0001
73927268|NCT01644175|147382374|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.9|||<|0.0001|TWO_SIDED|95.0|-56.2|-43.6||Threshold for significance was ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-43.6|-56.2|<0.0001
73927269|NCT01644175|147382375|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.4|||<|0.0001|TWO_SIDED|95.0|-53.6|-41.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.3|-53.6|<0.0001
73927270|NCT01644175|147382376|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.3|||<|0.0001|TWO_SIDED|95.0|-55.3|-43.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.3|-55.3|<0.0001
73927271|NCT01644175|147382377|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-41.3|-30.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.3|-41.3|<0.0001
73927272|NCT01644175|147382378|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-43.0|-32.0||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.0|-43.0|<0.0001
73927273|NCT01644175|147382379|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-43.5|-31.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.4|-43.5|<0.0001
73969602|NCT05505292|147478978|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Question 3b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.47
73927274|NCT01644175|147382380|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.4|||<|0.0001|TWO_SIDED|95.0|-46.4|-34.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.4|-46.4|<0.0001
73927275|NCT01644175|147382381|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.0|||<|0.0001|TWO_SIDED|95.0|-29.3|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.7|-29.3|<0.0001
73927276|NCT01644175|147382382|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-43.7|-32.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.7|-43.7|<0.0001
73927277|NCT01644175|147382383|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.1|||<|0.0001|TWO_SIDED|95.0|-46.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.9|-46.2|<0.0001
73969603|NCT05505292|147478978|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Question 4 change from baseline to week 8 in lifitegrast vs vehicle groups||||0.52
73969604|NCT05505292|147478978|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Question 5 change from baseline to week 8 in lifitegrast vs vehicle groups||||0.69
73969605|NCT03959696|147478979|SUPERIORITY||Mean Difference (Net)|0.36||||0.011|TWO_SIDED|95.0|0.08|0.64||A priori threshold for statistical significance is .05|Regression, Linear|We used a linear regression model with Generalized Estimating Equations (GEE) techniques to account for the patients-within-physicians data structure|Mean difference is the Training + Notification arm minus the Notification only arm|The null hypothesis SDMP is equal in the two arms||.64|.08|.011
73969606|NCT03959696|147478980|SUPERIORITY||Mean Difference (Net)|1.77||||0.36|TWO_SIDED|95.0|-2.01|5.55||A priori threshold for statistical significance is .05|Regression, Linear|We used a linear regression model with Generalized Estimating Equations (GEE) techniques to account for the patients-within-physicians data structure||The null hypothesis is that the two arms have the same knowledge score||5.55|-2.01|0.36
73969607|NCT03959696|147478981|SUPERIORITY|We will have 81% power to detect a difference of 14% in rates (e.g. decrease from 61% to 47%).||||||0.47|||||||Regression, Logistic|||We will compare the percentages of patients who received their preferred screening in the 12 months after the visit across the two groups using logistic regression model with the GEE approach to adjust for clustering of patients within clinicians.||||0.47
73969608|NCT03959696|147478982|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
74029318|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|1.57||||0.441|TWO_SIDED|95.0|0.508|5.328||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||5.328|0.508|0.441
73927278|NCT01644175|147382384|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.4|||<|0.0001|TWO_SIDED|95.0|-31.1|-21.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.7|-31.1|<0.0001
73969609|NCT03959696|147478983|SUPERIORITY||Risk Difference (RD)|9.4||||0.032|TWO_SIDED|95.0|0.9|18.0|||Chi-squared|||Null hypothesis was equal screening rate in both arms||18.0|0.9|0.032
73969610|NCT03959696|147478984|SUPERIORITY||Risk Difference (RD)|1.5||||0.64|TWO_SIDED||||||Chi-squared|||||||0.64
73969611|NCT02677805|147478991|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73969612|NCT02677805|147478992|SUPERIORITY|||||||0.087||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary Outcome Measure shows a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.087
74029319|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|5.351||||0.032|TWO_SIDED|95.0|1.383|35.172||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||35.172|1.383|0.032
73927279|NCT01644175|147382385|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|95.0|-51.6|-34.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.3|-51.6|<0.0001
73927280|NCT01644175|147382386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|38.5|||<|0.0001|TWO_SIDED|95.0|16.5|89.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||89.8|16.5|<0.0001
73969613|NCT02677805|147478993|SUPERIORITY|||||||0.121||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.121
73969614|NCT02677805|147478994|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Investigator's In-clinic Assessment||||<0.001
73969615|NCT02677805|147478994|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Subject's In-clinic Assessment||||<0.001
74029320|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|3.059||||0.175|TWO_SIDED|95.0|0.693|21.086||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||21.086|0.693|0.175
74087973|NCT02502734|147729818|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.|Mean Difference (Final Values)|-0.052|||||TWO_SIDED|95.0|-0.1217|0.0176||Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025,1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.|ANCOVA|Analysis performed using ANCOVA with covariates period-level baseline and subject-level baseline lower-leg length, age, gender, treatment and period.||||0.0176|-0.1217|
73927281|NCT01644175|147382387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|50.0|||<|0.0001|TWO_SIDED|95.0|20.6|121.0||Threshold for significance ≤ 0.05|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||121.0|20.6|<0.0001
73927282|NCT01644175|147382388|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.6|||<|0.0001|TWO_SIDED|95.0|-21.3|-7.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-7.9|-21.3|<0.0001
73927283|NCT01644175|147382389|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.0001|TWO_SIDED|95.0|3.6|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11.0|3.6|0.0001
73927284|NCT01644175|147382390|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6||||0.8699|TWO_SIDED|95.0|-8.3|7.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.0|-8.3|0.8699
73927285|NCT01324349|147382454|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0|||<|0.0001|||||||Log Rank||Median difference equals control median minus Hemostatic Patch median in minutes.|The primary effectiveness endpoint was time to hemostasis. The Kaplan-Meier method was used to estimate the survival distribution and to obtain the estimated median time to hemostasis for each treatment. Subjects who did not achieve hemostasis by 10 minutes were to be censored as of that time point. For each treatment, 95% Brookmeyer-Crowley confidence intervals for the median were computed based upon the sign test.||||<0.0001
73927286|NCT01324349|147382455|SUPERIORITY_OR_OTHER||Risk Difference (RD)|23.2||||0.0339|TWO_SIDED|95.0|1.9|47.3|||Suissa and Shuster test||Risk difference equals percentage hemostasis for Hemostatic Patch minus percentage hemostasis for control.|The secondary effectiveness endpoint was hemostasis within 3 minutes. The number and percentage of subjects who achieved hemostasis within 3 minutes are presented for each treatment group. The proportions of subjects who achieved hemostasis within 3 minutes were compared between treatments using the Suissa and Shuster test. Additionally, a 95% Blyth-Still-Casella confidence interval for the true proportion was computed for each treatment.||47.3|1.9|0.0339
73969616|NCT02677805|147478995|SUPERIORITY|||||||0.218||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for responders rates at week 20||||0.218
73969617|NCT02677805|147478996|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4||||<0.001
73969618|NCT02677805|147478996|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4||||<0.001
73969619|NCT02677805|147478996|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4.||||<0.001
73969620|NCT02677805|147478996|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4||||<0.001
73969621|NCT02677805|147478996|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Age Appraisal VAS score||||<0.001
73969622|NCT02547233|147479057|SUPERIORITY||Ratio of clearance rates|30.55|||<|0.001|TWO_SIDED|95.0|4.28|218.0|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|||218.0|4.28|<0.001
73969623|NCT02547233|147479058|SUPERIORITY||Ratio of clearance rates|12.26|||<|0.001|TWO_SIDED|95.0|4.73|31.78|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||31.78|4.73|<0.001
73969624|NCT02547233|147479059|SUPERIORITY||Ratio of clearance rates|10.31|||<|0.001|TWO_SIDED|95.0|4.43|23.97|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||23.97|4.43|<0.001
74029321|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|4.225||||0.071|TWO_SIDED|95.0|1.039|28.29||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||28.290|1.039|0.071
74029322|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|5.22||||0.035|TWO_SIDED|95.0|1.348|34.323||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||34.323|1.348|0.035
74029323|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|7.064||||0.011|TWO_SIDED|95.0|1.912|45.64||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||45.640|1.912|0.011
74029324|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|6.949||||0.012|TWO_SIDED|95.0|1.881|44.892||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||44.892|1.881|0.012
74029325|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|5.344||||0.032|TWO_SIDED|95.0|1.381|35.134||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||35.134|1.381|0.032
74029326|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|7.514||||0.008|TWO_SIDED|95.0|2.055|48.354||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||48.354|2.055|0.008
74029327|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|3.238||||0.026|TWO_SIDED|95.0|1.222|10.148||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||10.148|1.222|0.026
74029328|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|3.438||||0.019|TWO_SIDED|95.0|1.311|10.714||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||10.714|1.311|0.019
74029329|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|2.626||||0.037|TWO_SIDED|95.0|1.101|6.951||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||6.951|1.101|0.037
74029330|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|2.758||||0.027|TWO_SIDED|95.0|1.167|7.263||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||7.263|1.167|0.027
74029331|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|1.69||||0.21|TWO_SIDED|95.0|0.753|3.968||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.968|0.753|0.210
74029332|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|2.01||||0.087|TWO_SIDED|95.0|0.923|4.634||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.634|0.923|0.087
74029333|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|2.1||||0.148|TWO_SIDED|95.0|0.795|6.157||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||6.157|0.795|0.148
74029334|NCT04003155|147612904|SUPERIORITY||Odds Ratio (OR)|3.262||||0.015|TWO_SIDED|95.0|1.329|9.194||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||9.194|1.329|0.015
74029335|NCT02778867|147612918|OTHER|||||||0.58||||||α \< 0.05|Fisher Exact|Two-sided||||||0.58
74029336|NCT02778867|147612919|OTHER|||||||0.06||||||α \< 0.05|Fisher Exact|Two sided||||||0.06
74029337|NCT02778867|147612922|OTHER|||||||0.9||||||α \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.90
74029338|NCT02778867|147612923|OTHER|||||||0.22||||||α \< 0.05|t-test, 2 sided|Two sample t-test||||||0.22
74029339|NCT02778867|147612924|OTHER|||||||0.71||||||α \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.71
74029340|NCT02795767|147613027|OTHER||ABR Ratio|0.01|||||TWO_SIDED|95.0|0.006|0.023|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.|||0.023|0.006|
74029341|NCT02795767|147613028|OTHER||ABR Ratio|0.1|||||TWO_SIDED|95.0|0.051|0.21|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.|||0.210|0.051|
74029342|NCT02553915|147613057|OTHER|Comparisons were made for each biomarker within each arm pre and post 12 weeks of treatment.|||||<|0.1|||||||Kruskal-Wallis|||To evaluate whether a dose-response relationship exists between dose of EPA and decrease either in plasma IL-6 levels or in mitogen-stimulated PBMC TNF-α expression and secretion, when compared with placebo. \[Time Frame: 12 weeks\]. Comparisons were made within each arm pre and post 12 weeks of treatment.||||<0.10
74029343|NCT02553915|147613058|SUPERIORITY||||||<|0.1|||||||ANOVA|||"To evaluate:~1. whether EPA treatment produces a decrease in ratings of depression severity, when compared with placebo-treated subjects; and~2. whether the changes in IL-6 or mitogen- stimulated PBMC TNF-α expression mediate changes observed in ratings of depression.~\[Time Frame: 12 weeks\]"||||<0.1
74029344|NCT02553915|147613059|OTHER||||||<|0.01|||||||Kruskal-Wallis|||Change in IDS-C30 scores were compared pre and post 12 weeks of treatment with each intervention, within each arm.||||<0.01
73862661|NCT02564978|147271216|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.08||0.43|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on qualifying fellow eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.43
73862662|NCT02564978|147271216|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.89|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||Study eye + QFE: study \& qualifying fellow eyes analyzed as separate observations. Estimate: difference in rate of change in mean of appropriately transformed GA area between treatment and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study and qualifying fellow eyes together. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.89
73862663|NCT02564978|147271217|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.44|TWO_SIDED|95.0|-0.4|0.9||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.9|-0.4|0.44
73862664|NCT02564978|147271217|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.21|TWO_SIDED|95.0|-0.8|0.2||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.2|-0.8|0.21
73862665|NCT02564978|147271217|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.52|TWO_SIDED|95.0|-0.4|0.8||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.8|-0.4|0.52
73862666|NCT02564978|147271218|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.48|TWO_SIDED|95.0|-0.4|0.9||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.9|-0.4|0.48
73862667|NCT02564978|147271218|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.09|TWO_SIDED|95.0|-0.9|0.1||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.1|-0.9|0.09
73862668|NCT02564978|147271218|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.54|TWO_SIDED|95.0|-0.4|0.7||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.7|-0.4|0.54
73862669|NCT02564978|147271219|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.2|TWO_SIDED|95.0|-0.4|1.8||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||1.8|-0.4|0.20
73969625|NCT02547233|147479060|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.37||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.37|0.25|<0.001
74029345|NCT02553915|147613060|OTHER|Exploratory.|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in mitogen-stimulated PBMC IL-6. \[Time Frame: 12 weeks\] Comparisons were made between pre and post treatment levels in each of the 4 treatment arms.||||<0.1
73927287|NCT01324349|147382456|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.5||||0.5029|||||||Fisher Exact||Risk difference equals percent of subjects with any treatment emergent adverse events in control group minus percent of subjects with any treatment emergent adverse events in Hemostatic Patch group.|The incidence of subjects experiencing treatment-emergent adverse events (TEAEs) (defined under this protocol as Adverse Events) was summarized by MedDRA system organ class (SOC) and preferred term (PT) for each treatment group for the safety population. Tests for differences between the two treatments in the proportion of subjects experiencing any adverse event were made using Fisher's Exact Test.||||0.5029
73927288|NCT03200899|147382469|SUPERIORITY|||||||0.926|||||||ANCOVA|||||||0.926
73927289|NCT03200899|147382470|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.750
73927290|NCT03200899|147382471|SUPERIORITY|||||||0.129|||||||ANCOVA|||||||0.129
73927291|NCT03200899|147382472|SUPERIORITY|||||||0.152|||||||ANCOVA|||||||0.152
73927292|NCT03200899|147382473|SUPERIORITY|||||||0.037|||||||ANCOVA|||||||0.037
73927293|NCT03200899|147382474|SUPERIORITY|||||||0.297|||||||ANCOVA|||||||0.297
73927294|NCT03200899|147382475|SUPERIORITY|||||||0.293|||||||ANCOVA|||||||0.293
73927295|NCT03200899|147382476|SUPERIORITY|||||||0.045|||||||ANCOVA|||||||0.045
73927296|NCT04646499|147382479|SUPERIORITY|||||||0.34|||||||Sign test|||||||0.34
73927297|NCT04646499|147382480|SUPERIORITY|||||||0.024|||||||Sign test|||||||0.024
73927298|NCT04646499|147382481|SUPERIORITY|||||||0.083|||||||Sign test|||||||0.083
73927299|NCT04646499|147382482|SUPERIORITY|||||||0.049|||||||Sign test|||||||0.049
73927300|NCT04646499|147382483|SUPERIORITY|||||||0.31|||||||Sign test|||||||0.31
73927301|NCT02818218|147382556|SUPERIORITY||correlation coefficient|0.0005||||0.944|TWO_SIDED|98.3|-0.161|0.17|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.170|-0.161|0.944
73927302|NCT02818218|147382557|SUPERIORITY||correlation coefficient|0.27|||<|0.001|TWO_SIDED|98.3|0.11|0.42|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.42|0.11|<0.001
73927303|NCT02818218|147382558|SUPERIORITY||correlation coefficient|0.34|||<|0.001|TWO_SIDED|98.3|0.19|0.48|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.48|0.19|<0.001
73927304|NCT02818218|147382560|SUPERIORITY||correlation coefficient|0.07||||0.298|TWO_SIDED|98.3|-0.1|0.24|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.24|-0.10|0.298
73927305|NCT02818218|147382561|SUPERIORITY||correlation coefficient|0.22||||0.002|TWO_SIDED|98.3|0.05|0.37|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.37|0.05|0.002
73927306|NCT02818218|147382562|SUPERIORITY||correlation coefficient|0.33|||<|0.001|TWO_SIDED|98.3|0.17|0.47|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.47|0.17|<0.001
73927307|NCT00136084|147382569|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.624||||0.1559||95.0|0.832|3.205||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.041 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using a Monte Carlo approximation (10000 permutations) to an exact, risk-group stratified, test.|The odds ratio is defined as the ratio of the odds that a LDAC patient is MRD positive to the odds that a HDAC patient is MRD positive.|The study was designed to test the null hypothesis that HDAC and LDAC result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 186 MRD-evaluable patients in a 5-stage O'Brien-Fleming group sequential design gives 80% power at the 5% level to detect a change in the MRD-positive proportion from 0.50 to 0.30. The design was developed using East statistical software.||3.205|.832|.1559
73927308|NCT00136084|147382570|SUPERIORITY_OR_OTHER||Binomial proportion|0.733||||||95.0|0.449|0.922|||Binomial proportion|||Estimate of the proportion of negative minimal residual disease.||.922|.449|
73927309|NCT00136084|147382571|SUPERIORITY_OR_OTHER||Binomial proportion|0.931||||||95.0|0.772|0.992|||Binomial proportion|||||.992|.772|
73927310|NCT00136084|147382572|SUPERIORITY_OR_OTHER||Binomial proportion|0.9||||||95.0|0.735|0.979|||Binomial proportion|||||.979|.735|
73927311|NCT00136084|147382574|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
73927312|NCT00136084|147382575|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.0139||||0.2287|TWO_SIDED|95.0|-0.0365|0.00873|||Regression, Logistic|||||0.00873|-0.0365|0.2287
73927313|NCT00116831|147382614|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for atheroma volume|-4.58||||||95.0||||||||||||
73927314|NCT00116831|147382615|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for lumen volume|0.32||||||95.0||||||||||||
73927315|NCT00116831|147382616|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for vessel volume|-3.56||||||95.0||||||||||||
73927316|NCT00116831|147382618|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for atheroma area|-0.13||||||95.0||||||||||||
73927317|NCT00116831|147382619|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for lumen area|0.02||||||95.0||||||||||||
73927318|NCT00116831|147382620|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for vessel area|-0.11||||||95.0||||||||||||
73927319|NCT00116831|147382623|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-0.64||||0.1221||95.0|-1.457|0.173|||ANCOVA|||||0.173|-1.457|0.1221
73927320|NCT00116831|147382624|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-5.12||||||95.0||||||||||||
73927321|NCT00116831|147382626|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-1.72||||||95.0||||||||||||
73927322|NCT00116831|147382628|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-0.11||||||95.0||||||||||||
73927323|NCT00116831|147382629|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.1||||||95.0||||||||||||
74029346|NCT02553915|147613061|OTHER|Exploratory|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in the expression of inflammation pathway-related genes. \[Time Frame: 12 weeks\] (We evaluated gene expression of IL-6 and TNF-α.)||||<0.1
74029347|NCT02746679|147613129|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
74029348|NCT02746679|147613130|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74029349|NCT02746679|147613131|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74029350|NCT02746679|147613132|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||||||0.024
74029351|NCT02746679|147613133|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
74029352|NCT02746679|147613134|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.001
74087974|NCT01483625|147729824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0569|STANDARD_ERROR_OF_MEAN|0.055||0.3025|TWO_SIDED|95.0|-0.0516|0.1654|||Mixed effect repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Random:Patient. A spatial power covariance structure was used.||Tiotropium 18 mcg minus Placebo||0.1654|-0.0516|0.3025
74087975|NCT01483625|147729825|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|STANDARD_ERROR_OF_MEAN|0.44||0.7823|TWO_SIDED|95.0|0.9053|1.078|||2sample t quantiles with pooled variance|||Comparison Tiotropium 18 mcg Vs Placebo||1.0780|0.9053|0.7823
74087976|NCT01483625|147729826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0099|STANDARD_ERROR_OF_MEAN|0.0806||0.9025|TWO_SIDED|95.0|-0.1489|0.1686||Comparison Tiotropium 18 mcg Vs Placebo at Week 12|Mixed effects repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Patient was random. A spatial power covariance structure was used.||||0.1686|-0.1489|0.9025
73927324|NCT00116831|147382630|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.88||||||95.0||||||||||||
73927325|NCT00116831|147382631|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-47.23||||||95.0||||||||||||
74029353|NCT02746679|147613135|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.003
74029354|NCT02746679|147613136|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.024
74029355|NCT02746679|147613137|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.004
74029356|NCT02746679|147613138|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
74029357|NCT02746679|147613139|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
74029358|NCT02746679|147613140|SUPERIORITY_OR_OTHER|||||||0.277|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.277
74029359|NCT02746679|147613141|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.001
74029360|NCT01520922|147613174|SUPERIORITY_OR_OTHER||Percentage of participants|95.0|||||TWO_SIDED|95.0|84.53|99.44|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 90 mg/m\^2.|||99.44|84.53|
74029361|NCT01520922|147613174|SUPERIORITY_OR_OTHER||Percentage of participants|74.0|||||TWO_SIDED|95.0|59.67|84.74|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 70 mg/m\^2.|||84.74|59.67|
74029362|NCT01797029|147613245|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
74029363|NCT00798967|147613306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Cochran-Mantel-Haenszel (CMH) test adjusted for the randomization stratification variable (\<= 6 or \> 6 L/week of PN at baseline)|Cochran-Mantel-Haenszel|||||||0.002
74029364|NCT00798967|147613307|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Last Dosing Visit||||< 0.001
74029365|NCT01377467|147613308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.059|STANDARD_ERROR_OF_MEAN|0.967|<|0.001|TWO_SIDED|95.0|3.137|6.98|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|We calculated that a sample size of 43 patients per group would provide a statistical power of 86% to detect a 4% difference in the percentage change of areal BMD at the total lumbar spine at 12 months, using a two-sided t-test with an α-level of 0.05 and assuming a mean ± SD change of 4 ± 6% in the denosumab group and 0 ± 6% in the control group. To account for a dropout rate of 5%, it was planned to randomize a total of 90 patients.||6.980|3.137|<0.001
74087977|NCT01483625|147729829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.061|STANDARD_ERROR_OF_MEAN|3.0115||0.1797|TWO_SIDED|95.0|-10.0157|1.8938|||t-test, 2 sided|95% confidence interval is based on 2 sample t quantiles using pooled variance.||Comparison Tiotropium 18 mcg Vs Placebo Over 12 Weeks||1.8938|-10.0157|0.1797
74087978|NCT05444543|147729834|SUPERIORITY||Odds Ratio (OR)|0.089||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
74087979|NCT05444543|147729835|SUPERIORITY||Odds Ratio (OR)|1.1|||>|0.99|TWO_SIDED||||||Chi-squared|||||||>0.99
73927326|NCT00116831|147382632|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-16.9||||||95.0||||||||||||
73927327|NCT00116831|147382634|SUPERIORITY_OR_OTHER||Ratio to GLP as % difference from GLP|30.591||||||95.0||||||||||||
74029366|NCT01377467|147613309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.895|STANDARD_ERROR_OF_MEAN|0.887||0.035|TWO_SIDED|95.0|0.132|3.659|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.659|0.132|0.035
74029367|NCT01377467|147613310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.059|STANDARD_ERROR_OF_MEAN|1.201||0.38|TWO_SIDED|95.0|-1.329|3.447|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.447|-1.329|0.380
74029368|NCT01377467|147613311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.567|STANDARD_ERROR_OF_MEAN|0.806|<|0.001|TWO_SIDED|95.0|2.975|6.178|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||6.178|2.975|<0.001
73927328|NCT00116831|147382635|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|7.642||||||95.0||||||||||||
73927329|NCT00116831|147382636|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|7.316||||||95.0||||||||||||
74029369|NCT01377467|147613312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.756|STANDARD_ERROR_OF_MEAN|0.662||0.009|TWO_SIDED|95.0|0.44|3.072|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.072|0.440|0.009
74029370|NCT01377467|147613313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.035|STANDARD_ERROR_OF_MEAN|1.085||0.064|TWO_SIDED|95.0|-0.122|4.193|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||4.193|-0.122|0.064
73927330|NCT00116831|147382637|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|15.731||||||95.0||||||||||||
73927331|NCT00116831|147382638|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|3.998||||||95.0||||||||||||
73927332|NCT00116831|147382639|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|11.728||||||95.0||||||||||||
73927333|NCT00116831|147382640|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-6.768||||||95.0||||||||||||
73927334|NCT00116831|147382641|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-14.478||||||95.0||||||||||||
73927335|NCT00116831|147382642|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.462||||||95.0||||||||||||
73927336|NCT00116831|147382643|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.0164||||||95.0||||||||||||
73927337|NCT00116831|147382644|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.118||||||95.0||||||||||||
73927338|NCT00116831|147382645|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.14||||||95.0||||||||||||
73969626|NCT05329220|147479155|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.89||||0.635|TWO_SIDED|97.5|0.5|1.57||P-value corresponds to Cohort 1 ABNCoV2 comparison to Cohort 1 Comirnaty|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||1.57|0.50|0.6350
74029371|NCT01377467|147613314|SUPERIORITY_OR_OTHER||between-subjects effect|10.466|||<|0.001|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p=0.007. Time\*treatment interaction: p=0.002. The a priori threshold for statistical significance is \<0.05.|||||<0.001
73927339|NCT00380393|147382649|OTHER||Vaccine Efficacy|52.9|||<|0.001|TWO_SIDED|95.0|28.1|69.1|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum||69.1|28.1|<0.001
73927340|NCT00380393|147382649|OTHER||Vaccine Efficacy|55.0|||<|0.001|TWO_SIDED|95.0|31.4|70.4|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum||70.4|31.4|<0.001
74029372|NCT01377467|147613315|SUPERIORITY_OR_OTHER||between-subjects effect|275622.016|||<|0.001|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.012. The a priori threshold for statistical significance is \<0.05.|||||<0.001
74087980|NCT00707447|147729865|SUPERIORITY_OR_OTHER||||||<|0.05||||||There was only one primary outcome variable, thus no adjustments for multiple comparisons were made.|t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons||||<.05
73927341|NCT00380393|147382650|OTHER||Vaccine efficacy|54.6|||<|0.001|TWO_SIDED|95.0|31.2|70.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||70.0|31.2|<0.001
73927342|NCT00380393|147382650|OTHER||Vaccine efficacy|56.5|||<|0.001|TWO_SIDED|95.0|34.2|71.2|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum.||71.2|34.2|<0.001
73927343|NCT00380393|147382651|OTHER||Vaccine efficacy|55.8||||0.0003|TWO_SIDED|95.0|31.0|71.7|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||71.7|31.0|0.0003
73927344|NCT00380393|147382651|OTHER||Vaccine efficacy|57.9|||<|0.001|TWO_SIDED|95.0|34.3|73.0|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.0|34.3|<0.001
73927345|NCT00380393|147382652|OTHER||Vaccine efficacy|58.0|||<|0.001|TWO_SIDED|95.0|34.8|73.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.0|34.8|<0.001
73927346|NCT00380393|147382652|OTHER||Vaccine efficacy|59.5|||<|0.001|TWO_SIDED|95.0|37.1|73.9|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.9|37.1|<0.001
73927347|NCT01933048|147382671|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.43|||||||Farrington-Manning Method|based on margin of 0.05||A/H1N1||||0.43
73927348|NCT01933048|147382671|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.8|||||||Farrington-Manning Method|based on margin of 0.05||A/H3N2||||0.80
73927349|NCT01933048|147382671|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.55|||||||Farrington-Manning Method|based on margin of 0.05||B/Yamagata||||0.55
73927350|NCT01933048|147382671|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.16|||||||Farrington-Manning Method|based on margin of 0.05||B/Brisbane||||0.16
73927351|NCT02404311|147382720|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
73927352|NCT02404311|147382720|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
73862670|NCT02564978|147271219|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.02|TWO_SIDED|95.0|0.4|3.1||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||3.1|0.4|0.02
73862671|NCT02564978|147271219|SUPERIORITY|Number of eyes contributing to this analysis exceeds the number of eyes contributing to the study eye only analysis since one participant had relevant data for the qualifying fellow eye but not the study eye.|Mean Difference (Final Values)|1.0||||0.06|TWO_SIDED|95.0|0.0|2.0||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||2.0|0.0|0.06
73862672|NCT04332614|147271273|SUPERIORITY||Odds Ratio (OR)|0.8791371||||0.0248|TWO_SIDED|95.0|0.7856042|0.9838058||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9838058|0.7856042|0.0248
73862673|NCT04332614|147271273|SUPERIORITY||Odds Ratio (OR)|0.5980109|||<|0.0001|TWO_SIDED|95.0|0.5159511|0.6931219||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.6931219|0.5159511|<0.0001
73862674|NCT04332614|147271273|SUPERIORITY||Odds Ratio (OR)|0.8380003||||0.0133|TWO_SIDED|95.0|0.7285712|0.9638653||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9638653|0.7285712|0.0133
73862675|NCT04332614|147271274|SUPERIORITY||Odds Ratio (OR)|0.3700794|||<|0.0001|TWO_SIDED|95.0|0.2870513|0.4771231||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4771231|0.2870513|<0.0001
73862676|NCT04332614|147271274|SUPERIORITY||Odds Ratio (OR)|0.285144|||<|0.0001|TWO_SIDED|95.0|0.1881589|0.4321194||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4321194|0.1881589|<0.0001
73862677|NCT04332614|147271274|SUPERIORITY||Odds Ratio (OR)|0.5565905||||0.0003|TWO_SIDED|95.0|0.4059477|0.7631354||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.7631354|0.4059477|0.0003
73927353|NCT02404311|147382720|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
73927354|NCT02404311|147382721|OTHER||Geometric Mean difference (Net)|0.914|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
74029373|NCT01377467|147613316|SUPERIORITY_OR_OTHER||between-subjects effect|0.717||||0.014|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p\<0.001. The a priori threshold for statistical significance is \<0.05.|||||0.014
73862678|NCT04332614|147271275|SUPERIORITY||Odds Ratio (OR)|0.72429741||||0.103|TWO_SIDED|95.0|0.49167734|1.0669736||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.0669736|0.49167734|0.103
73862679|NCT04332614|147271275|SUPERIORITY||Odds Ratio (OR)|0.63578603||||0.12|TWO_SIDED|95.0|0.35943749|1.1246013||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.1246013|0.35943749|0.120
73862680|NCT04332614|147271275|SUPERIORITY||Odds Ratio (OR)|1.06482385||||0.789|TWO_SIDED|95.0|0.67282661|1.6852036||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.6852036|0.67282661|0.789
73862681|NCT04332614|147271276|SUPERIORITY||Odds Ratio (OR)|0.8837908||||0.0286|TWO_SIDED|95.0|0.7912382|0.9871694||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9871694|0.7912382|0.0286
73862682|NCT04332614|147271276|SUPERIORITY||Odds Ratio (OR)|0.6000149|||<|0.0001|TWO_SIDED|95.0|0.5193168|0.6932528||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.6932528|0.5193168|<0.0001
73927355|NCT02404311|147382721|OTHER||Geometric Mean difference (Net)|0.945|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
73927356|NCT02404311|147382721|OTHER||Geometric Mean difference (Net)|0.895|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
73927357|NCT02404311|147382722|OTHER||Proportion Difference (Net)|0.0||||0.0215|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0215
74029374|NCT01377467|147613317|SUPERIORITY_OR_OTHER||between-subjects effect|0.707||||0.068|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.047. The a priori threshold for statistical significance is \<0.05.|||||0.068
74029375|NCT01377467|147613318|SUPERIORITY_OR_OTHER||between-subjects effect|99952.126||||0.114|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.047. The a priori threshold for statistical significance is \<0.05.|||||0.114
74087981|NCT00707447|147729866|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons||||<.05
73927358|NCT02404311|147382722|OTHER||Proportion Difference (Net)|0.0||||0.0003|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0003
73927359|NCT02404311|147382722|OTHER||Proportion Difference (Net)|0.228||||0.001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0010
73862683|NCT04332614|147271276|SUPERIORITY||Odds Ratio (OR)|0.8225743||||0.0055|TWO_SIDED|95.0|0.7167043|0.9440832|||Regression, Logistic|||||0.9440832|0.7167043|0.0055
73927360|NCT02404311|147382723|OTHER||Geometric Mean difference (Net)|0.0|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
73927361|NCT02404311|147382723|OTHER||Geometric Mean difference (Net)|0.0|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
73927362|NCT02404311|147382723|OTHER||Geometric Mean difference (Net)|6.099||||0.0002|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0002
73927363|NCT02404311|147382724|OTHER||Proportion Difference (Net)|0.018||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
73927364|NCT02404311|147382724|OTHER||Proportion Difference (Net)|0.036||||0.6698|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.6698
73927365|NCT02404311|147382724|OTHER||Proportion Difference (Net)|0.125||||0.1435|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.1435
73927366|NCT02404311|147382725|OTHER||Geometric Mean difference (Net)|0.965||||0.9661|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.9661
74087982|NCT00707447|147729867|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74087983|NCT00707447|147729868|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74087984|NCT00707447|147729869|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74087985|NCT00707447|147729870|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74087986|NCT00707447|147729871|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74087987|NCT00707447|147729872|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74087988|NCT00707447|147729873|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74087989|NCT00707447|147729874|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74087990|NCT01682148|147729881|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a responder rate (π) of 63% in the reference group, a clinically relevant delta (Δ) of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.0986|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.0986
74087991|NCT01682148|147729881|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.5682|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.5682
74087992|NCT01682148|147729881|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.8543|TWO_SIDED|5.0|-0.363|0.0284||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.8543
74087993|NCT01682148|147729881|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.9167|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.9167
73927367|NCT02404311|147382725|OTHER||Geometric Mean difference (Net)|1.118||||0.8593|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.8593
73927368|NCT02404311|147382725|OTHER||Geometric Mean difference (Net)|1.138||||0.4396|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.4396
73927369|NCT00526058|147382736|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the Futura system to the Secura system would be demonstrated if the upper bound of the 90% confidence interval (CI) for the difference between the two systems (Secura-Futura) in percent change of LDL-C measurements from pre- to post-treatment is less than the noninferiority margin 5.7%.||||||0.005|TWO_SIDED|90.0|||||ANOVA|||||||0.005
73927370|NCT00218296|147382739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.04|TWO_SIDED|95.0|0.26|0.99|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.99|0.26|0.04
73927371|NCT00218296|147382740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28||||0.019|TWO_SIDED|95.0|0.07|0.83|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.83|0.07|0.019
73927372|NCT00218296|147382741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.03|TWO_SIDED|95.0|0.18|0.94|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.94|0.18|0.03
73927373|NCT00218296|147382742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.002|TWO_SIDED|95.0|0.004|0.48|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.48|0.004|.002
73927374|NCT00218296|147382743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.056|TWO_SIDED|95.0|0.2|1.03|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||1.03|0.20|0.056
73927375|NCT00218296|147382744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.002|TWO_SIDED|95.0|0.004|0.48||There were no adjustments in the analysis.|Chi-squared||The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.48|0.004|0.002
73927376|NCT01203072|147382787|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance level for Cochran-Armitage test and comparison using Shirley-Williams method was set at one-sided, 0.025. For other tests, significance level and confidence coefficient were set at two-sided, 0.05 and 0.95, respectively, unless specified|Cochran-Armitage|||As the primary analysis, the dose-response relationship in the incidence of thromboembolic event was verified using the Cochran-Armitage test.||||<0.001
73969627|NCT05329220|147479155|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.8||||0.0002|TWO_SIDED|97.5|0.7|0.92||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.92|0.70|0.0002
74029376|NCT01377467|147613319|SUPERIORITY_OR_OTHER||between-subjects effect|84.83||||0.578|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.593. The a priori threshold for statistical significance is \<0.05.|||||0.578
73927377|NCT03735667|147382827|NON_INFERIORITY|A Bayesian analysis based on 10,000 samples from the posterior distribution, using a piecewise exponential survival model. The criteria for non-inferiority is met if the posterior probability of non-inferiority is greater than the non-inferiority test threshold.|||||||||||||||||A Bayesian analysis was used to test the non-inferiority hypothesis for the primary endpoint using a non-inferiority margin of 8%. The pre-specified success criteria (the non-inferiority test threshold) was a posterior probability of non-inferiority greater than 97.5%. The observed posterior probability of non-inferiority was 77.9%. The posterior median percentage difference in the rate of the primary outcome was 6.63% (95% Bayesian credible interval: 3.04% to 10.20%).|||
73927378|NCT01094548|147382856|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
74029377|NCT01377467|147613320|SUPERIORITY_OR_OTHER||between-subjects effect|248.686||||0.607|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.296. The a priori threshold for statistical significance is \<0.05.|||||0.607
74029378|NCT01377467|147613321|SUPERIORITY_OR_OTHER||z value|-2.342||||0.019|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.019
73927379|NCT01094548|147382860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.431||||0.094|TWO_SIDED|95.0|0.157|1.185|||Log Rank|||||1.185|0.157|0.0940
73927380|NCT01094548|147382861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.3919|TWO_SIDED|95.0|0.261|1.698|||Log Rank|||||1.698|0.261|0.3919
73927381|NCT00591942|147382897|NON_INFERIORITY|95% CI were used|KM Survival Curves|0.5637||||0.5637|TWO_SIDED||||||Chi-squared|df=1||||||0.5637
73927382|NCT02063737|147382898|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3882||||0.083|TWO_SIDED|95.0|-0.8272|0.0508|||Mixed Models Analysis|adjusting for shift length|Adjusted difference between intervention groups (intervention - control) from the linear mixed model adjusting for shift length and repeated measures within individuals.|||0.0508|-0.8272|0.0830
73927383|NCT02063737|147382899|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.0114
73927384|NCT02063737|147382900|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||ANCOVA|adjusting for the baseline measure||||||.99
73927385|NCT02063737|147382901|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||ANCOVA|adjusted for baseline measure||||||0.0927
73927386|NCT02063737|147382902|SUPERIORITY_OR_OTHER|||||||0.0578|TWO_SIDED||||||ANCOVA|adjusting for the baseline measure||||||0.0578
73927387|NCT02063737|147382903|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.69
73927388|NCT02063737|147382904|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.65
73969628|NCT05329220|147479156|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.76||||0.0008|TWO_SIDED|97.5|0.64|0.91||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron variant BA.4/BA.5|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.91|0.64|0.0008
73969629|NCT05329220|147479156|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.69|||<|0.0001|TWO_SIDED|97.5|0.59|0.81||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron Variant XBB.1.5.|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.81|0.59|<0.0001
73927389|NCT02063737|147382905|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.95
73927390|NCT02063737|147382906|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.21
73927391|NCT02063737|147382907|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.51
73927392|NCT02063737|147382908|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.28
73927393|NCT02063737|147382909|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.0930
73927394|NCT02063737|147382910|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.56
73927395|NCT02063737|147382911|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.20
73927396|NCT00694369|147382939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|ANOVA|"Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value~for 120-mg dose comparison is significant)."||||||<0.001
73927397|NCT00694369|147382939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|ANOVA|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)||||||<0.001
73969630|NCT04204265|147479159|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
73927398|NCT00694369|147382939|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.06||||||95.0|-1.37|1.48|||||Difference in Least squares means (LS Means) (etoricoxib minus ibuprofen)|||1.48|-1.37|
73927399|NCT00694369|147382939|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.43||||||95.0|-0.73|1.6|||||Difference in LS Means (etoricoxib minus ibuprofen)|||1.60|-0.73|
73927400|NCT00694369|147382939|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus cetaminophen/codeine) is -2.41.|Difference in LS Means|3.9||||||95.0|2.04|5.76|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)|||5.76|2.04|
73927401|NCT00694369|147382939|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus acetaminophen/codeine) is -2.41.|Difference in LS Means|4.27||||||95.0|2.61|5.94|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)|||5.94|2.61|
73927402|NCT00694369|147382939|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.38||||||95.0|-1.8|1.05|||||Difference in LS Means (etoricoxib 120 mg minus etoricoxib 90 mg)|||1.05|-1.80|
73927403|NCT00694369|147382939|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|10.59||||||95.0|8.72|12.47|||||Difference in LS Means (ibuprofen 2400 mg minus placebo)|||12.47|8.72|
73927404|NCT00694369|147382939|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|6.75||||||95.0|4.53|8.97|||||Difference in LS Means (acetaminophen 2400 mg/codeine 240 mg minus placebo)|||8.97|4.53|
73927405|NCT00694369|147382940|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant).||||||<0.001
73927406|NCT00694369|147382940|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)||||||<0.001
73927407|NCT00694369|147382940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.161||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used, and the nominal p-value for 90-mg dose comparison was not reported.||||||0.161
73927408|NCT00694369|147382940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.||||||0.014
73927409|NCT00694369|147382940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.||||||0.007
73927410|NCT00314236|147382941|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||ANCOVA|||||||0.011
73927411|NCT00314236|147382942|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||ANCOVA|||||||0.033
73927412|NCT00746941|147383040|SUPERIORITY_OR_OTHER|||||||0.7132|||||||Student's t-test|||||||0.7132
73969631|NCT04204265|147479160|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
73969632|NCT04204265|147479161|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
74029379|NCT01377467|147613322|SUPERIORITY_OR_OTHER||z value|-2.049||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
73862684|NCT04332614|147271277|SUPERIORITY||Odds Ratio (OR)|0.3948795|||<|0.0001|TWO_SIDED|95.0|0.310437|0.5022914||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.5022914|0.3104370|<0.0001
73927413|NCT00746941|147383041|SUPERIORITY_OR_OTHER|||||||0.9086|||||||Student's t-test|||||||0.9086
73927414|NCT03316885|147383050|OTHER|The performance target in support of the primary effectiveness was percentage of eyes achieving objective monocular BCDVA at 1 year postoperative (Visit 5A) compared to the a priori SPE percentage of 92.5%. This is for the All Implanted Analysis Set (AAS) (as reported in EN ISO 11979-7:2014).|Comparison|100.0|||||ONE_SIDED|95.0||100.0||||||||100.0||
73927415|NCT03316885|147383051|OTHER|The performance target in support of the primary effectiveness was percentage of eyes achieving objective monocular BCDVA at 1 year postoperative (Visit 5A) compared to the a priori SPE percentage of 92.5%. This is for the All Implanted Analysis Set (AAS) (as reported in EN ISO 11979-7:2014).|Comparison|100.0|||||ONE_SIDED|95.0||100.0||||||||100.0||
73927416|NCT02180412|147383078|OTHER||Slope|7.76||||0.0434|TWO_SIDED|95.0|2.14|13.37|||ANCOVA|||ALA Day 1 vs Day 2||13.37|2.14|.0434
73927417|NCT02180412|147383078|OTHER||Slope|16.29||||0.0003|TWO_SIDED|95.0|11.32|21.25|||ANCOVA|||ALA Day 1 vs Day 3||21.25|11.32|.0003
73927418|NCT02180412|147383078|OTHER||Slope|15.98||||0.0198|TWO_SIDED|95.0|6.7|25.26|||ANCOVA|||ALA Day 1 vs Day 4||25.26|6.7|.0198
73927419|NCT02180412|147383078|OTHER||Slope|10.69||||0.158|TWO_SIDED|95.0|-1.67|22.49|||ANCOVA|||PBG Day 1 vs Day 2||22.49|-1.67|.158
73927420|NCT02180412|147383078|OTHER||Slope|24.52||||0.0127|TWO_SIDED|95.0|11.3|37.74|||ANCOVA|||PGB Day 1 vs Day 3||37.74|11.3|.0127
73927421|NCT02180412|147383078|OTHER||Slope|28.45||||0.0328|TWO_SIDED|95.0|9.64|47.27|||ANCOVA|||PBG Day 1 vs Day 4||47.27|9.64|.0328
73927422|NCT02180412|147383078|OTHER||Slope|12.2||||0.9993|TWO_SIDED|95.0|-465.4|489.8|||ANCOVA|||Total Porphyrins Day 1 vs Day 2||489.8|-465.4|.9993
73927423|NCT02180412|147383078|OTHER||Slope|454.5||||0.2915|TWO_SIDED|95.0|-200.87|1109.86|||ANCOVA|||Total Porphyrins Day 1 vs Day 3||1109.86|-200.87|.2915
73927424|NCT02180412|147383078|OTHER||Slope|326.12||||0.4382|TWO_SIDED|95.0|-292.0|944.25|||ANCOVA|||Total Porphyrins Day 1 vs Day 4||944.25|-292|.4382
73927425|NCT00680901|147383083|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3492|TWO_SIDED|95.0|0.73|1.12||Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Log Rank||Pike estimator of HR was based on the stratified log rank test.|Primary Analysis: OS (PE population)||1.12|0.73|0.3492
73927426|NCT00680901|147383084|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3244|TWO_SIDED|95.0|0.74|1.1||Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Log Rank||Pike estimator of HR was based on the stratified log rank test.|Primary Analysis: OS (ITT population)||1.10|0.74|0.3244
73927427|NCT04809220|147383102|SUPERIORITY||LS Mean Difference|-0.29|||<|0.001|TWO_SIDED|95.0|-0.43|-0.14|||Mixed Models Analysis|||||-0.14|-0.43|<.001
73927428|NCT04809220|147383103|SUPERIORITY||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.47|-0.15|||Mixed Models Analysis|||||-0.15|-0.47|<.001
73969633|NCT03931174|147479178|SUPERIORITY|Unit of analysis is the provider level. All 186 providers (95 ATTC, 91 E-ATTC) who enrolled in the study are included in the analysis.|Odds Ratio (OR)|2.41|STANDARD_ERROR_OF_MEAN|0.53||0.097|TWO_SIDED|95.0|0.85|6.81||CM Exposure is reported as the estimated proportion of providers delivering 10 or more CM sessions to at least one patient in a mixed model accounting for nesting.|Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||6.81|0.85|0.097
73969634|NCT03931174|147479179|SUPERIORITY|Unit of analysis is the provider level. All 186 providers (95 ATTC, 91 E-ATTC) who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.31||0.02|TWO_SIDED|95.0|0.11|1.32|||t-test, 2 sided|T-test adjusted for inequality of variances||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||1.32|0.11|0.02
74029380|NCT01377467|147613323|SUPERIORITY_OR_OTHER||z value|-0.937||||0.371|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.371
74029381|NCT01377467|147613324|SUPERIORITY_OR_OTHER||z value|-2.752||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.005
74029382|NCT01377467|147613325|SUPERIORITY_OR_OTHER||z value|-2.166||||0.031|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.031
74029383|NCT01377467|147613326|SUPERIORITY_OR_OTHER||z value|-1.288||||0.212|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.212
74029384|NCT01377467|147613327|SUPERIORITY_OR_OTHER||z value|-1.64||||0.108|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.108
74029385|NCT01377467|147613328|SUPERIORITY_OR_OTHER||z value|-1.991||||0.048|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.048
74029386|NCT00336492|147613331|SUPERIORITY_OR_OTHER|||||||0.146|||||||Chi-squared|||||||0.146
74029387|NCT00227877|147613332|SUPERIORITY||Adjusted Relative Risk Ratio|1.39|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|1.08|1.8|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.80|1.08|< 0.05
73927429|NCT04809220|147383104|SUPERIORITY||Odds Ratio (OR)|1.15||||0.56|TWO_SIDED|95.0|0.71|1.87|||Generalized Linear Mixed Model (GLM)|||For HbA1c ≤6.5%||1.87|0.71|0.560
73927430|NCT04809220|147383104|SUPERIORITY||Odds Ratio (OR)|1.61||||0.028|TWO_SIDED|95.0|1.05|2.45|||Generalized Linear Mixed Model (GLM)|||For HbA1c \< 7%||2.45|1.05|0.028
73927431|NCT04809220|147383105|SUPERIORITY||LS Mean Difference|-9.4|||<|0.001|TWO_SIDED|95.0|-14.4|-4.3|||Mixed Models Analysis|||||-4.3|-14.4|<.001
73927432|NCT04809220|147383106|SUPERIORITY||LS Mean Difference|-7.2||||0.002|TWO_SIDED|95.0|-11.7|-2.7|||ANCOVA|||Morning premeal-fasting||-2.7|-11.7|0.002
73927433|NCT04809220|147383106|SUPERIORITY||LS Mean Difference|-10.1||||0.016|TWO_SIDED|95.0|-18.3|-1.9|||ANCOVA|||Morning 2-hour post meal||-1.9|-18.3|0.016
73927434|NCT04809220|147383106|SUPERIORITY||LS Mean Difference|-8.3||||0.007|TWO_SIDED|95.0|-14.2|-2.3|||ANCOVA|||Midday premeal||-2.3|-14.2|0.007
73927435|NCT04809220|147383106|SUPERIORITY||LS Mean Difference|-12.5||||0.002|TWO_SIDED|95.0|-20.5|-4.5|||ANCOVA|||Midday 2-hour post meal||-4.5|-20.5|0.002
74029388|NCT00227877|147613333|SUPERIORITY||Adjusted Relative Risk Ratio|0.7|STANDARD_ERROR_OF_MEAN|0.25||0.32|TWO_SIDED|95.0|0.34|1.42|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.42|0.34|.32
74029389|NCT00227877|147613334|SUPERIORITY||Adjusted Relative Risk Ratio|1.8|STANDARD_ERROR_OF_MEAN|0.55||0.05|TWO_SIDED|95.0|0.99|3.27|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|||Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|3.27|.99|0.05
73927436|NCT04809220|147383106|SUPERIORITY||LS Mean Difference|-3.9||||0.158|TWO_SIDED|95.0|-9.3|1.5|||ANCOVA|||Evening premeal||1.5|-9.3|0.158
73927437|NCT04809220|147383106|SUPERIORITY||LS Mean Difference|-11.3||||0.004|TWO_SIDED|95.0|-19.0|-3.7|||ANCOVA|||Evening 2-hour post meal||-3.7|-19.0|0.004
73927438|NCT04809220|147383107|SUPERIORITY||LS Mean Difference|-0.3||||0.213|TWO_SIDED|95.0|-0.8|0.2|||Mixed Models Analysis|||||0.2|-0.8|0.213
73927439|NCT02641379|147383115|SUPERIORITY_OR_OTHER|||||||0.1002|||||||Chi-squared|||For Genotype I, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.1002
73927440|NCT02641379|147383115|SUPERIORITY_OR_OTHER|||||||0.0184|||||||Chi-squared|||For Genotype I, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.0184
73927441|NCT02641379|147383115|SUPERIORITY_OR_OTHER|||||||0.091|||||||Chi-squared|||For Genotype IV, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.0910
73927442|NCT02641379|147383115|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||For Genotype IV, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||1.0000
73927443|NCT02641379|147383116|SUPERIORITY_OR_OTHER|||||||0.0021||||||The SVR rate i.e., 32.1% participants with genotype I who achieved SVR with 95 % confidence interval of 20.3 to 46.0 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype I.||||0.0021
73927444|NCT02641379|147383116|SUPERIORITY_OR_OTHER|||||||0.3031||||||The SVR rate i.e., 20.0% participants with genotype IV who achieved SVR with 95 % confidence interval of 0.5 to 71.6 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype IV||||0.3031
73927445|NCT00181961|147383136|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||.016
73927446|NCT01667978|147383137|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73927447|NCT02531321|147383141|OTHER|Unpaired t test with Welch's correction|||||<|0.05|||||||t-test, 2 sided|||||||<.05
73927448|NCT00692770|147383144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||=|0.258329|TWO_SIDED|95.0|0.78|1.134||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.134|0.78|=0.258329
73927449|NCT00692770|147383145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.891|||=|0.121383|TWO_SIDED|95.0|0.735|1.081||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.081|0.735|=0.121383
73927450|NCT00692770|147383146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.995|||=|0.484742|TWO_SIDED|95.0|0.761|1.3||One-sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.3|0.761|=0.484742
73927451|NCT00692770|147383147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||<|0.0001|TWO_SIDED|95.0|0.025|0.052|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D index score. Statistical tests were performed with a 2 sided type I error of 5%.||0.052|0.025|<0.0001
73927452|NCT00692770|147383148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.978|||<|0.0001|TWO_SIDED|95.0|1.797|4.159|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D VAS score. Statistical tests were performed with a 2 sided type I error of 5%.||4.159|1.797|<0.0001
73927453|NCT00692770|147383149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||<|0.0001|TWO_SIDED|95.0|3.5|6.7|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-HEP score. Statistical tests were performed with a 2 sided type I error of 5%.||6.7|3.5|<0.0001
73927454|NCT00692770|147383150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.4|3.6|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-G score. Statistical tests were performed with a 2 sided type I error of 5%.||3.6|1.4|<0.0001
73927455|NCT00692770|147383151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.562|||||TWO_SIDED|95.0|1.241|1.965|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||1.965|1.241|
73927456|NCT00692770|147383152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.747|||||TWO_SIDED|95.0|1.407|2.17|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||2.170|1.407|
73927457|NCT00692770|147383153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|1.206|2.018|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||2.018|1.206|
73927458|NCT02917031|147383178|SUPERIORITY||Mean Difference (Final Values)|-2.595||||0.252|TWO_SIDED|95.0|-7.04|1.85|||ANCOVA|||Change from baseline, saxagliptin versus placebo.||1.850|-7.040|0.252
73927459|NCT02917031|147383179|SUPERIORITY||Mean Difference (Final Values)|-1.631||||0.425|TWO_SIDED|95.0|-5.635|2.373|||ANCOVA|||Saxagliptin: Change from baseline||2.373|-5.635|0.425
73927460|NCT02917031|147383180|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.925|TWO_SIDED|95.0|-1.996|2.197|||ANCOVA|||"Saxagliptin vs Placebo:~Change from baseline"||2.197|-1.996|0.925
73927461|NCT02917031|147383181|SUPERIORITY||Mean Difference (Final Values)|-3.605||||0.105|TWO_SIDED|95.0|-7.97|0.76|||ANCOVA|||Saxagliptin vs placebo: Change from baseline||0.760|-7.970|0.105
73927462|NCT02917031|147383182|SUPERIORITY||Ratio for relative change|0.971||||0.796|TWO_SIDED|95.0|0.777|1.214|||ANCOVA|||Saxagliptin vs placebo: Change from baseline||1.214|0.777|0.796
73969635|NCT03931174|147479180|SUPERIORITY|Unit of analysis is the organization-level. Total number of organizations included in the analysis is 28 (14 ATTC, 14 E-ATTC).|Chi-square test statistic value|0.662||||0.43|TWO_SIDED||||||Chi-squared|Pearson Chi-Square||These analyses are unadjusted.||||0.430
73969636|NCT03931174|147479181|SUPERIORITY|Analyses are at the patient-level. All patients who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|-0.695|STANDARD_ERROR_OF_MEAN|0.313||0.034|TWO_SIDED|95.0|-1.3|-0.08|||Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||-0.08|-1.30|.034
73927463|NCT03722017|147383187|SUPERIORITY||Risk Ratio (RR)|0.91||||0.006|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge Timepoint||||0.006
73927464|NCT03722017|147383187|SUPERIORITY||Risk Ratio (RR)|0.93||||0.11|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the SNF Discharge Timepoint||||0.110
73927465|NCT03722017|147383187|SUPERIORITY||Risk Ratio (RR)|0.92||||0.06|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow-Up Timepoint||||0.060
73927466|NCT03722017|147383188|SUPERIORITY||Mean Difference (Net)|-0.049||||0.738|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge Timepoint||||0.738
73927467|NCT03722017|147383188|SUPERIORITY||Mean Difference (Net)|0.001||||0.995|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the SNF Discharge Timepoint||||0.995
73927468|NCT03722017|147383188|SUPERIORITY||Mean Difference (Net)|0.058||||0.721|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow Up Timepoint||||0.721
73927469|NCT03711162|147383205|SUPERIORITY||Least square (LS) mean difference|22.7|STANDARD_ERROR_OF_MEAN|38.12||0.5525|TWO_SIDED|95.0|-52.3|97.6||P-value: based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from the mixed model.||||97.6|-52.3|0.5525
73927470|NCT03711162|147383205|SUPERIORITY||LS mean difference|-26.7|STANDARD_ERROR_OF_MEAN|37.53||0.4776|TWO_SIDED|95.0|-100.5|47.1||P-value: based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||47.1|-100.5|0.4776
73927471|NCT03711162|147383206|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9648|TWO_SIDED|95.0|0.56|1.74|||Regression, Logistic|||||1.74|0.56|0.9648
73927472|NCT03711162|147383206|SUPERIORITY||Odds Ratio (OR)|1.05||||0.853|TWO_SIDED|95.0|0.6|1.84|||Regression, Logistic|||||1.84|0.60|0.8530
73927473|NCT03711162|147383207|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.5|2.05|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.|||2.05|0.50|
73927474|NCT03711162|147383207|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.47|1.88|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.|||1.88|0.47|
73927475|NCT03711162|147383208|SUPERIORITY||LS mean difference|-0.5||||0.785|TWO_SIDED|95.0|-4.4|3.3|||Mixed Models Analysis||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|||3.3|-4.4|0.7850
73927476|NCT03711162|147383208|SUPERIORITY||LS mean difference|0.3||||0.8617|TWO_SIDED|95.0|-3.4|4.1|||Mixed Models Analysis||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|||4.1|-3.4|0.8617
73927477|NCT03711162|147383209|SUPERIORITY||LS Mean difference|19.4|STANDARD_ERROR_OF_MEAN|33.68|||TWO_SIDED|95.0|-46.9|85.7|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||85.7|-46.9|
73969637|NCT03931174|147479182|SUPERIORITY|Analyses are at the patient-level. All patients who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.314||0.27|TWO_SIDED|95.0|-0.82|0.41|||Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.41|-0.82|0.27
73862685|NCT04332614|147271277|SUPERIORITY||Odds Ratio (OR)|0.2790595|||<|0.0001|TWO_SIDED|95.0|0.1875017|0.4153254||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4153254|0.1875017|<0.0001
73862686|NCT04332614|147271277|SUPERIORITY||Odds Ratio (OR)|0.6097538||||0.0011|TWO_SIDED|95.0|0.4528751|0.8209762||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.8209762|0.4528751|0.0011
73862687|NCT04332614|147271278|SUPERIORITY||Odds Ratio (OR)|1.0049587||||0.976|TWO_SIDED|95.0|0.72693253|1.3893201||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.3893201|0.72693253|0.976
73862688|NCT04332614|147271278|SUPERIORITY||Odds Ratio (OR)|0.7576895||||0.246|TWO_SIDED|95.0|0.4741259|1.2108458||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.2108458|0.47412590|0.246
73862689|NCT04332614|147271278|SUPERIORITY||Odds Ratio (OR)|1.1728665||||0.428|TWO_SIDED|95.0|0.79090107|1.7393021||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.7393021|0.79090107|0.428
73862690|NCT04332614|147271279|SUPERIORITY||Odds Ratio (OR)|0.9980487||||1|TWO_SIDED|95.0|0.8680298|1.147543||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.147543|0.8680298|1
73862691|NCT04332614|147271279|SUPERIORITY||Odds Ratio (OR)|0.8953032||||0.276|TWO_SIDED|95.0|0.7771682|1.031395||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.031395|0.7771682|0.276
73862692|NCT04332614|147271279|SUPERIORITY||Odds Ratio (OR)|0.8970536||||0.289|TWO_SIDED|95.0|0.7785981|1.033531||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.033531|0.7785981|0.289
73862693|NCT04332614|147271280|SUPERIORITY||Odds Ratio (OR)|0.9313889||||0.94591|TWO_SIDED|95.0|0.6003591|1.444944||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.444944|0.6003591|0.94591
73927478|NCT03711162|147383209|SUPERIORITY||LS Mean difference|-29.1|STANDARD_ERROR_OF_MEAN|32.95|||TWO_SIDED|95.0|-93.9|35.8|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||35.8|-93.9|
73927479|NCT03711162|147383210|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.68|1.95|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.95|0.68|
73927480|NCT03711162|147383210|SUPERIORITY||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.74|2.09|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||2.09|0.74|
73862694|NCT04332614|147271280|SUPERIORITY||Odds Ratio (OR)|1.8998642||||0.0041|TWO_SIDED|95.0|1.2809137|2.817898||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.817898|1.2809137|0.0041
73927481|NCT03711162|147383211|SUPERIORITY||LS mean difference|3.7|||||TWO_SIDED|95.0|-11.5|19.0|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||19.0|-11.5|
73927482|NCT03711162|147383211|SUPERIORITY||LS mean difference|2.9|||||TWO_SIDED|95.0|-11.1|16.8|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||16.8|-11.1|
73927483|NCT03711162|147383212|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.65|1.78|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||1.78|0.65|
73862695|NCT04332614|147271280|SUPERIORITY||Odds Ratio (OR)|2.0398184||||0.0015|TWO_SIDED|95.0|1.3648075|3.048678||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||3.048678|1.3648075|0.0015
73862696|NCT04332614|147271281|SUPERIORITY||Odds Ratio (OR)|1.180837||||0.829|TWO_SIDED|95.0|0.6750639|2.065546||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.065546|0.6750639|0.829
73862697|NCT04332614|147271281|SUPERIORITY||Odds Ratio (OR)|1.432003||||0.404|TWO_SIDED|95.0|0.8279689|2.476702||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.476702|0.8279689|0.404
73862698|NCT04332614|147271281|SUPERIORITY||Odds Ratio (OR)|1.212702||||0.753|TWO_SIDED|95.0|0.7161724|2.05348||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.053480|0.7161724|0.753
73862699|NCT04332614|147271282|SUPERIORITY||Odds Ratio (OR)|0.9747188||||0.9284|TWO_SIDED|95.0|0.8501783|1.1175028||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.1175028|0.8501783|0.9284
73862700|NCT04332614|147271282|SUPERIORITY||Odds Ratio (OR)|0.8518974||||0.0612|TWO_SIDED|95.0|0.741461|0.9787827||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||0.9787827|0.7414610|0.0612
73862701|NCT04332614|147271282|SUPERIORITY||Odds Ratio (OR)|0.873993||||0.1407|TWO_SIDED|95.0|0.7602296|1.0047804||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.0047804|0.7602296|0.1407
73927484|NCT03711162|147383212|SUPERIORITY||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.76|1.98|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||1.98|0.76|
73927485|NCT03711162|147383215|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.44|3.81|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||3.81|0.44|
73927486|NCT03711162|147383215|SUPERIORITY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.42|3.5|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||3.50|0.42|
73927487|NCT03711162|147383216|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.66|4.08|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.08|0.66|
73927488|NCT03711162|147383216|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.36|2.61|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||2.61|0.36|
73927489|NCT03711162|147383217|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.66|4.08|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.08|0.66|
73927490|NCT03711162|147383217|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.36|2.61|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||2.61|0.36|
73927491|NCT03711162|147383218|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.59|1.91|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||1.91|0.59|
73927492|NCT03711162|147383218|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.43|1.46|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||1.46|0.43|
73927493|NCT03711162|147383219|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.59|1.91|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.|||1.91|0.59|
73927494|NCT03711162|147383219|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.43|1.46|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.|||1.46|0.43|
73927495|NCT00394212|147383259|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||P-value from non-parametric Mann-Whitney-Wilcoxon test comparing treatments.|Wilcoxon (Mann-Whitney)|||Based on a 2-group test of means for unequal variance and unequal sample size (2:1 randomization ratio) with alpha = 0.05 and a power of 80%, the sample size required was 132; 88 subjects in the Transoral Suturing arm and 44 in the Sham Endoscopy arm. The study was prematurely discontinued due to reasons unrelated to safety and effectiveness and therefore was underpowered for evaluation of the primary and secondary hypotheses.||||0.066
73927496|NCT00394212|147383260|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||P-value from two-sided Fisher's exact test comparing percents achieving 15% EWL at 6 months for the two treatments.|Fisher Exact|||||||0.317
73927497|NCT00394212|147383261|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.|Fisher Exact|||||||0.019
73927498|NCT00394212|147383262|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.|Fisher Exact|||||||0.174
73927499|NCT03240133|147383265|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|-6.98||||0.0024|TWO_SIDED|95.0|-11.37|-2.6|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 750mg berotralstat or placebo.||-2.6|-11.37|0.0024
73927500|NCT03240133|147383265|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|-2.1||||0.6424|TWO_SIDED|95.0|-11.49|7.29|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 500mg berotralstat or placebo.||7.29|-11.49|0.6424
73927501|NCT03240133|147383265|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|0.57||||0.8283|TWO_SIDED|95.0|-4.9|6.03|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 250mg berotralstat or placebo.||6.03|-4.9|0.8283
73927502|NCT03240133|147383266|SUPERIORITY||Odds Ratio (OR)|0.196||||0.0029|TWO_SIDED|95.0|0.069|0.559|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 750 mg-treated-attack requiring SOC-Rx was 0.196 that of a placebo attack.||0.559|0.069|0.0029
73927503|NCT03240133|147383266|SUPERIORITY||Odds Ratio (OR)|0.472||||0.4048|TWO_SIDED|95.0|0.074|2.988|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 500 mg-treated-attack requiring SOC-Rx was 0.472 that of a placebo attack.||2.988|0.074|0.4048
73927504|NCT03240133|147383266|SUPERIORITY||Odds Ratio (OR)|0.587||||0.5984|TWO_SIDED|95.0|0.073|4.733|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 250 mg-treated-attack requiring SOC-Rx was 0.587 that of a placebo attack.||4.733|0.073|0.5984
73927505|NCT00110812|147383277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|134.0|||<|0.001|TWO_SIDED|95.0|70.0|198.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.||||198|70|<.001
73927506|NCT00110812|147383277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|133.0|||<|0.001|TWO_SIDED|95.0|68.0|199.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.||||199|68|<.001
73927507|NCT00110812|147383279|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.31||||0.01|TWO_SIDED|95.0|0.08|0.54|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.||||.54|.08|.01
73927508|NCT00110812|147383279|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.36||||0.003|TWO_SIDED|95.0|0.12|0.6|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.||||.60|.12|.003
73927509|NCT00110812|147383280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|65.8||||0.009||95.0|||||ANOVA|ANOVA with stratification by region and adjustment for baseline CD4||||||.009
73927510|NCT00110812|147383280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|58.2||||0.02||95.0|||||ANOVA|stratified by region and adjusted for baseline CD4||||||.02
73927511|NCT00110812|147383283|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.08||||0.14|TWO_SIDED|95.0|0.59|43.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 alone compared to patients not taking IL-2.|||43.6|0.59|.14
73927512|NCT00110812|147383283|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.56||||0.08|TWO_SIDED|95.0|0.8|53.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 plus pericycle HAART compared to patients not receiving IL-2|||53.6|0.80|.08
73969638|NCT03931174|147479183|SUPERIORITY|Analyses are at the provider-level. Only those providers who completed the post-implementation survey (at the end of the 9-month implementation phase) were included in the analysis.|Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.191||0.011|TWO_SIDED|95.0|-0.88|0.12||Means were compared between conditions in an independent-samples T-test.|t-test, 2 sided|T-test adjusted for inequality of variances||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.12|-0.88|.011
73969639|NCT03931174|147479184|SUPERIORITY|Analyses are at the provider-level. Only those providers who completed the post-implementation survey (at the end of the 9-month implementation phase) were included in the analysis.|Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.232||0.218|TWO_SIDED|95.0|-0.75|0.17||Means of leadership engagement scores were compared between conditions in an independent-samples T-test.|t-test, 2 sided|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.17|-0.75|.218
73969640|NCT03492216|147479233|SUPERIORITY||Risk Difference (RD)|7.6||||0.0025|TWO_SIDED|95.0|2.7|12.5|||Regression, Logistic||adjusted risk difference for non-hazardous alcohol use, alcohol incentive groups compared to no alcohol incentive groups. logistic regression model adjusted for INH incentive arm, participant sex, and study site.|||12.5|2.7|0.0025
73927513|NCT00110812|147383284|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58||||0.048|TWO_SIDED|95.0|0.34|0.99|||Regression, Cox||IL-2 without ART vs control group|||.99|.34|.048
73927514|NCT00110812|147383284|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.17|0.62|||Regression, Cox||IL-2 with pericycle HAART compared to control|||.62|.17|<.001
73927515|NCT00110812|147383285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.34||||0.03|TWO_SIDED|95.0|0.03|0.64|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA||||0.64|0.03|.03
73927516|NCT00110812|147383285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.54|||<|0.001|TWO_SIDED|95.0|0.24|0.85|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA||||0.85|0.24|<.001
73927517|NCT00110812|147383288|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.45||||0.59|TWO_SIDED|95.0|0.38|5.45|||Regression, Cox|Stratification by region.|IL-2 group compared to control group|||5.45|0.38|.59
73927518|NCT00110812|147383289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-55.9|STANDARD_ERROR_OF_MEAN|28.4||0.05||95.0|||||ANOVA|Last measured CD4 is imputed if month 24 CD4 count is missing. Analysis is adjusted for baseline CD4.|IL-2 group minus control group CD4.|||||.05
73927519|NCT00110812|147383291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.03|TWO_SIDED|95.0|0.52|0.97|||Regression, Cox||IL-2 groups vs. control|||.97|.52|.03
73927520|NCT03865329|147383296|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
73927521|NCT03865329|147383297|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
73927522|NCT03865329|147383299|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
73927523|NCT03865329|147383300|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
73927524|NCT01988571|147383324|SUPERIORITY|Power described in protocol.|Mean Difference (Net)|0.1608|STANDARD_ERROR_OF_MEAN|0.7787||0.84|TWO_SIDED||||||ANCOVA|Adjusted for multiple imputation of missing data||Linear models adjusting for baseline values and utilized multiple imputation for missing data.||||0.84
73927525|NCT00004412|147383334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.05|TWO_SIDED||||||Fisher Exact|||Percentage of ulcers undergoing partial and complete healing compared at 12 weeks. Mean Ulcer areas were calculated utilizing computerized planimetry, ulcer area tracings, and photography for baseline and 12 weeks and compared between the two study Arms.||||0.05
73927526|NCT02346136|147383337|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.62|TWO_SIDED|95.0|-0.62|0.37||Tested as two-tailed p\<0.025 to accommodate two co-primary outcomes|Mixed Models Analysis|||||0.37|-0.62|0.62
73927527|NCT02346136|147383338|SUPERIORITY||Risk Ratio (RR)|0.535||||0.194|TWO_SIDED|95.0|0.182|1.57|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.|||1.57|0.182|0.194
73927528|NCT02346136|147383339|SUPERIORITY||Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|0.94||0.5|TWO_SIDED|95.0|-2.53|1.24|||Mixed Models Analysis|||||1.24|-2.53|.50
73927529|NCT02346136|147383340|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED|95.0|-0.04|0.05|||Mixed Models Analysis|||Gait NW velocity variable||.05|-.04|.85
73927530|NCT02346136|147383340|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.26|TWO_SIDED|95.0|-0.02|0.06|||Mixed Models Analysis|||Gait DT velocity variable||.06|-.02|.26
73927531|NCT02346136|147383341|SUPERIORITY||Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.02||0.84|TWO_SIDED|95.0|-0.04|0.03|||Mixed Models Analysis|||||0.03|-0.04|0.84
73927532|NCT02346136|147383342|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.71||0.26|TWO_SIDED|95.0|-0.61|2.22|||Mixed Models Analysis|||||2.22|-0.61|.26
73927533|NCT02346136|147383343|SUPERIORITY||Median Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|7.29||0.92|TWO_SIDED|95.0|-13.9|15.3|||Mixed Models Analysis|||||15.3|-13.9|.92
73927534|NCT02346136|147383344|SUPERIORITY||Median Difference (Net)|1.36|STANDARD_ERROR_OF_MEAN|9.28||0.88|TWO_SIDED|95.0|-17.2|19.9|||Mixed Models Analysis|||||19.9|-17.2|.88
73927535|NCT02346136|147383345|SUPERIORITY||Mean Difference (Net)|0.85|STANDARD_ERROR_OF_MEAN|1.43||0.55|TWO_SIDED|95.0|-2.0|3.71|||Mixed Models Analysis|||Physical component score||3.71|-2.00|.55
73927536|NCT02346136|147383345|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.66||0.51|TWO_SIDED|95.0|-4.41|2.21|||Mixed Models Analysis|||Mental component score||2.21|-4.41|.51
73927537|NCT02346136|147383346|SUPERIORITY||Median Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.0||0.69|TWO_SIDED|95.0|-1.6|2.41|||Mixed Models Analysis|||||2.41|-1.60|.69
73927538|NCT02346136|147383347|SUPERIORITY||Mean Difference (Net)|2.14|STANDARD_ERROR_OF_MEAN|2.56||0.41|TWO_SIDED|95.0|-2.98|7.26||to accommodate two co-primary outcomes|Mixed Models Analysis|||||7.26|-2.98|0.41
73927539|NCT02346136|147383349|SUPERIORITY||Risk Ratio (RR)|0.476||||0.06|TWO_SIDED|95.0|0.216|1.05|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.|||1.05|0.216|0.060
74029390|NCT00227877|147613335|SUPERIORITY||Adjusted Relative Risk Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED|95.0|0.53|1.16|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.16|.53|0.23
73927540|NCT02346136|147383350|SUPERIORITY||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|0.81||0.13|TWO_SIDED|95.0|-0.4|2.94|||Mixed Models Analysis|||||2.94|-0.40|0.13
74029391|NCT00227877|147613336|SUPERIORITY||Adjusted Relative Risk Ratio|1.52|STANDARD_ERROR_OF_MEAN|0.34||0.07|TWO_SIDED|95.0|0.97|2.36|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.|||2.36|.97|.07
73927541|NCT01052545|147383356|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Descriptive statistics were used to estimate the incidence rates per 1,000 bed-days and 95% confidence intervals (CI) for urine cultures ordered, ASB overtreatment and CAUTI under-treatment in each study period.|Regression, Logistic|to test whether there was a significant difference in monthly urine cultures ordered between the two study sites over time.||||||<0.05
73927542|NCT01052545|147383362|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||We used χ2 test, Fisher's exact test and one-way ANOVA to determine if patient-level covariates differed between the baseline, intervention and maintenance periods at each study site.|Regression, Logistic|||||||<0.05
73927543|NCT00453999|147383363|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED||||||Log Rank|Differences between groups by log-rank statistic stratified by oxygen saturation and duration of illness at randomization, and flu season.||||||0.306
73927544|NCT00453999|147383364|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Sore Throat: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
73927545|NCT00453999|147383364|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Nasal Congestion: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
73927546|NCT00453999|147383364|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Cough: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
73927547|NCT00453999|147383364|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Aches and Pains: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
73927548|NCT00453999|147383364|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Fatigue: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
73927549|NCT00453999|147383364|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Headache: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
73927550|NCT00453999|147383364|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Feeling Feverish: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
73927551|NCT00453999|147383365|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Log Rank|||||||0.276
73927552|NCT00453999|147383367|SUPERIORITY_OR_OTHER|||||||0.994|TWO_SIDED||||||Log Rank|||||||0.994
73927553|NCT00453999|147383368|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 12 hours||||>0.05
73927554|NCT00453999|147383368|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 24 hours||||>0.05
73927555|NCT00453999|147383368|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 36 hours||||>0.05
73927556|NCT00453999|147383368|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 48 hours||||>0.05
73927557|NCT00453999|147383368|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 72 hours||||>0.05
73927558|NCT00453999|147383368|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 96 hours||||>0.05
73927559|NCT00802412|147383370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.51|TWO_SIDED|95.0|0.4|6.5|||Regression, Logistic|||||6.5|0.4|0.51
73927560|NCT00802412|147383370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.45|TWO_SIDED|95.0|0.66|2.55|||Regression, Cox|||||2.55|0.66|.45
73927561|NCT04120610|147383411|OTHER||Correlation|0.26|||||TWO_SIDED|95.0|0.1|0.41||||||Descriptive analysis of endpoint with no hypothesis.||0.41|0.10|
73927562|NCT04120610|147383412|OTHER||Correlation|-0.26|||||TWO_SIDED|95.0|-0.46|-0.03||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||-0.03|-0.46|
73927563|NCT04120610|147383412|OTHER||Correlation|-0.33|||||TWO_SIDED|95.0|-0.51|-0.12||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||-0.12|-0.51|
73927564|NCT04120610|147383412|OTHER||Correlation|-0.13|||||TWO_SIDED|95.0|-0.38|0.14||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||0.14|-0.38|
73927565|NCT04120610|147383413|OTHER||Correlation|-0.34|||||TWO_SIDED|95.0|-0.52|-0.12||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||-0.12|-0.52|
73927566|NCT04120610|147383413|OTHER||Correlation|-0.35|||||TWO_SIDED|95.0|-0.52|-0.15||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||-0.15|-0.52|
73927567|NCT04120610|147383413|OTHER||Correlation|-0.24|||||TWO_SIDED|95.0|-0.47|0.02||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||0.02|-0.47|
73927568|NCT04120610|147383414|OTHER||Correlation|0.15|||||TWO_SIDED|95.0|-0.08|0.36||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.36|-0.08|
73927569|NCT04120610|147383414|OTHER||Correlation|0.19|||||TWO_SIDED|95.0|-0.02|0.39||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.39|-0.02|
73927570|NCT04120610|147383414|OTHER||Correlation|0.24|||||TWO_SIDED|95.0|-0.02|0.47||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.47|-0.02|
73927571|NCT03712410|147383420|OTHER|Group Comparisons||||||0.186||||||p-value for Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)|Kruskal-Wallis|||||||0.1860
73927572|NCT03712410|147383420|OTHER|Group Comparisons||||||0.2752||||||p-value for Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)|Kruskal-Wallis|||||||0.2752
73927573|NCT03712410|147383420|OTHER|Group Comparisons||||||0.6233||||||p-value for Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)|Kruskal-Wallis|||||||0.6233
73927574|NCT03712410|147383421|OTHER|Group Comparison||||||0.5638||||||p-value for Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)|Wilcoxon (Mann-Whitney)|||||||0.5638
73927575|NCT03712410|147383421|OTHER|Group Comparisons||||||0.9848||||||p-value for Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)|Wilcoxon (Mann-Whitney)|||||||0.9848
73927576|NCT03712410|147383421|OTHER|Group Comparisons||||||0.9169||||||p-value for Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)|Wilcoxon (Mann-Whitney)|||||||0.9169
73927577|NCT03712410|147383422|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Generalised Anxiety Disorder Assessment (GAD-7) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
73927578|NCT03712410|147383422|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Patient Health Questionnaire 9 (PHQ9) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
73927579|NCT03712410|147383422|OTHER|Group Comparisons||||||0.0155||||||p-value for Caregiver Quality of Life Index (CQLI-R) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||0.0155
73927580|NCT03712410|147383422|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Generalised Anxiety Disorder Assessment (GAD-7) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
73927581|NCT03712410|147383422|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Patient Health Questionnaire 9 (PHQ9) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
73927582|NCT03712410|147383422|OTHER|Group Comparisons||||||0.0504||||||p-value for Caregiver Quality of Life Index (CQLI-R) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||0.0504
73927583|NCT06049043|147383430|SUPERIORITY||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|0.04||0.26|TWO_SIDED|95.0|-14.02|3.84|||t-test, 2 sided|||||3.84|-14.02|0.26
73927584|NCT06049043|147383431|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|4.84||0.44|TWO_SIDED|95.0|-13.43|5.85|||t-test, 2 sided|||||5.85|-13.43|0.44
73927585|NCT06049043|147383432|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.44||0.62|TWO_SIDED|95.0|-0.66|1.1|||t-test, 2 sided|||||1.10|-0.66|0.62
73927586|NCT06049043|147383433|SUPERIORITY||Mean Difference (Final Values)|6.34|STANDARD_ERROR_OF_MEAN|0.04||0.16|TWO_SIDED|95.0|-2.5|15.18|||t-test, 2 sided|||||15.18|-2.50|0.16
73927587|NCT06049043|147383433|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.28|TWO_SIDED|95.0|-0.13|0.04|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.04|-0.13|0.28
73927588|NCT06049043|147383434|SUPERIORITY||Mean Difference (Final Values)|1.98|STANDARD_ERROR_OF_MEAN|4.67||0.67|TWO_SIDED|95.0|-7.31|11.28|||t-test, 2 sided|||||11.28|-7.31|0.67
73927589|NCT06049043|147383434|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED|95.0|-0.12|0.08|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.08|-0.12|0.69
73927590|NCT06049043|147383435|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.32||0.09|TWO_SIDED|95.0|-0.09|1.18|||t-test, 2 sided|||||1.18|-0.09|0.09
73927591|NCT06049043|147383435|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|0.36||0.71|TWO_SIDED|95.0|-0.86|0.59|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.59|-0.86|0.71
73927592|NCT06049043|147383436|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.34||0.08|TWO_SIDED|95.0|-0.07|1.27|||t-test, 2 sided|||||1.27|-0.07|0.08
73927593|NCT06049043|147383436|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.42||0.39|TWO_SIDED|95.0|-1.21|0.48|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.48|-1.21|0.39
73927594|NCT06049043|147383438|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.22||0.89|TWO_SIDED|95.0|-0.95|0.82|||t-test, 2 sided|||||0.82|-0.95|0.89
73927595|NCT01354496|147383445|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.03|||||TWO_SIDED|90.0|0.897|1.18|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.18|0.897|
74029392|NCT00227877|147613337|SUPERIORITY||Adjusted Relative Risk Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.41||0.93|TWO_SIDED|95.0|0.42|2.21|||Regression, Logistic||Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.|||2.21|.42|.93
73927596|NCT01354496|147383446|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.06|||||TWO_SIDED|90.0|0.922|1.22|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.22|0.922|
73927597|NCT01354496|147383447|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.02|||||TWO_SIDED|90.0|0.896|1.16|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.16|0.896|
73927598|NCT01354496|147383448|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.882|1.15|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.15|0.882|
73927599|NCT01354496|147383450|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.993|||||TWO_SIDED|90.0|0.951|1.04|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.04|0.951|
73927600|NCT01354496|147383450|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.943|||||TWO_SIDED|90.0|0.905|0.983|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||0.983|0.905|
73927601|NCT01354496|147383451|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.98|||||TWO_SIDED|90.0|0.926|1.04|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.04|0.926|
73927602|NCT01354496|147383451|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.94|||||TWO_SIDED|90.0|0.891|0.993|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||0.993|0.891|
73927603|NCT01228747|147383456|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-56.13|STANDARD_ERROR_OF_MEAN|6.15|<|0.0001|TWO_SIDED|95.0|-68.24|-44.02||Statistical testing was 2-sided, and was performed using a significance (α) level of 0.05.|ANCOVA|||"The statistical hypotheses, null hypothesis (H0) and alternate hypothesis (H1), are stated below:~H0: μLEV = μPBO vs. H1: μLEV ≠ μPBO~ANCOVA on the endpoint percentage change from Combined Baseline of GTC seizures per week using treatment and country as factors (categorical predictors) and Combined Baseline GTC seizure frequency per week as a covariate (a continuous predictor) where μLEV and μPBO are adjusted means for LEV and PBO, respectively."||-44.02|-68.24|<0.0001
73927604|NCT04982250|147383476|SUPERIORITY||Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-26.0|11.0|||||Risk differences (RD) with 95% confidence intervals (CI) were estimated using regression models with Gaussian distributions, identify links, study group fixed effects, and index peer random effects (to adjust for clustering).|The sample size calculation was based on the primary PrEP initiation outcome at follow-up; 80 clusters (40 per study group) provided 80% power to detect a 17% difference in PrEP initiation between the enhanced (80%) and standard (63%) groups, assuming three referred peers per cluster (75% of those recommended), an intra-cluster correlation coefficient of 0.05, and an alpha level of 0.05.||11|-26|
73927605|NCT04982250|147383481|SUPERIORITY||Risk Difference (RD)|39.0|||||TWO_SIDED|95.0|24.0|54.0||||||||54|24|
73927606|NCT04982250|147383482|SUPERIORITY||Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-10.0|13.0||||||||13|-10|
73927607|NCT04982250|147383483|SUPERIORITY||Risk Difference (RD)|-19.0|||||TWO_SIDED|95.0|-40.0|2.0||||||||2|-40|
73927608|NCT04982250|147383484|SUPERIORITY||Median Difference (Final Values)|-16.9|||||TWO_SIDED|95.0|-36.3|2.5||||||||2.5|-36.3|
73927609|NCT04982250|147383485|SUPERIORITY||Median Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.2|1.1||||||||1.1|-0.2|
73927610|NCT04258605|147383505|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<.0001
73927611|NCT04258605|147383506|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
73927612|NCT04258605|147383507|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
73927613|NCT04258605|147383508|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
73969641|NCT03492216|147479234|SUPERIORITY||Risk Difference (RD)|-0.2||||0.9435|TWO_SIDED|95.0|-7.0|6.5|||Regression, Logistic||adjusted risk difference for \>90% INH adherence, INH incentive group compared to no INH incentives. logistic regression model adjusted for alcohol incentive arm, participant sex and study site.|||6.5|-7.0|0.9435
73969642|NCT03492216|147479237|SUPERIORITY||Risk Difference (RD)|-2.5||||0.26|TWO_SIDED|95.0|-6.8|1.9|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 2 (escalating incentives; EtG tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||1.9|-6.8|0.26
73969643|NCT03492216|147479237|SUPERIORITY||Risk Difference (RD)|0.7||||0.7|TWO_SIDED|95.0|-2.8|4.1|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 3 (escalating incentives; IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||4.1|-2.8|0.70
73969644|NCT03492216|147479237|SUPERIORITY||Risk Difference (RD)|1.3||||0.42|TWO_SIDED|95.0|-1.9|4.5|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 4 (escalating incentives; EtG and IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||4.5|-1.9|0.42
73969645|NCT05020249|147479277|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
73969646|NCT05020249|147479278|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
73969647|NCT05020249|147479279|SUPERIORITY|||||||0.08||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||0.080
73927614|NCT00828191|147383534|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-2.5||||0.52|TWO_SIDED|95.0|-9.4|4.4|||Fisher Exact|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc\>= Pe + d(-10%) H1 : Pc\< Pe + d(-10%)"||4.4|-9.4|0.52
73927615|NCT00828191|147383535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.48||0.54|TWO_SIDED|95.0|-7.6|4.0|||ANOVA|||||4.0|-7.6|0.54
73927616|NCT00828191|147383536|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.0||||0.62|TWO_SIDED|95.0|-8.8|4.8|||Fisher Exact|||||4.8|-8.8|0.62
73927617|NCT02196324|147383587|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.34|=|0.0111|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|||||-0.2|-1.5|= 0.0111
73927618|NCT02196324|147383588|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.43|=|0.0248|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||||-0.1|-1.8|= 0.0248
73927619|NCT02196324|147383589|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.47||0.0005|TWO_SIDED|95.0|-2.6|-0.7|||Mixed Models Analysis|||||-0.7|-2.6|0.0005
73969648|NCT05020249|147479280|SUPERIORITY|||||||0.08||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||0.080
73969649|NCT05020249|147479281|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
73862702|NCT04332614|147271283|SUPERIORITY||Odds Ratio (OR)|0.9089673||||0.8848|TWO_SIDED|95.0|0.6109603|1.352333||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.352333|0.6109603|0.8848
73927620|NCT02196324|147383595|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.4|0.0||||||Week 2||-0.0|-1.4|
73927621|NCT02196324|147383595|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.7|-0.1||||||Week 4||-0.1|-1.7|
73927622|NCT02196324|147383595|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0175|TWO_SIDED|95.0|-2.0|-0.2||p-value assume equal variance|t-test, 2 sided|||Week 8||-0.2|-2.0|0.0175
73969650|NCT05020249|147479282|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
73969651|NCT05020249|147479283|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
73927623|NCT02196324|147383596|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-3.1|1.6||||||Week 2||1.6|-3.1|
73927624|NCT02196324|147383596|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.7|2.3||||||Week 4||2.3|-2.7|
73927625|NCT02196324|147383596|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-3.6|2.1||||||Week 8||2.1|-3.6|
73927626|NCT02196324|147383597|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.4|0.1||||||Week 2||0.1|-0.4|
73927627|NCT02196324|147383597|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.4|0.2||||||Week 4||0.2|-0.4|
73927628|NCT02196324|147383597|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||Week 8||0.1|-0.6|
73927629|NCT02196324|147383598|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.0625|TWO_SIDED|95.0|-0.02|0.72||p-value assume equal variance.|t-test, 2 sided|||||0.72|-0.02|0.0625
73927630|NCT01888497|147383817|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|13.82|||<|0.001|TWO_SIDED|95.0|10.85|17.4||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam versus (vs) placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||17.40|10.85|<0.001
73969652|NCT05020249|147479284|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
73969653|NCT05020249|147479285|SUPERIORITY||Odds Ratio (OR)|81.25|||<|0.001|TWO_SIDED|95.0|8.216|803.544||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio of scalp IGA response for bimekizumab group compared with placebo group using CMH.||803.544|8.216|<0.001
73969654|NCT05020249|147479286|SUPERIORITY||Odds Ratio (OR)|12.353||||0.007|TWO_SIDED|95.0|1.447|105.443||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio of DLQI total score response for bimekizumab group compared with placebo group using CMH.||105.443|1.447|0.007
73969655|NCT05020249|147479287|SUPERIORITY||LS Mean Difference|-80.444|||<|0.001|TWO_SIDED|95.0|-102.509|-58.379|||ANCOVA|||||-58.379|-102.509|<0.001
73969656|NCT01073566|147479306|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Pre-study power calculations determined that 28 completed subjects provided 90% power to detect equivalence for the primary endpoint of MDBG of bolus-patch compared to pen/syringe using a 2-sided alpha level of 0.05, when the margin of equivalence for MDBG is 1.11 mmol/L, the true mean difference is 0.0, and the standard deviation of the differences is 1.72 mmol/L.|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.24||0.098|TWO_SIDED|95.0|-0.97|0.16|||ANOVA||Finesse versus usual injection device.|A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.||0.16|-0.97|0.098
73927631|NCT01888497|147383817|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95 percent (%) confidence interval (CI) was 2.4 cm.|Hodges-Lehman estimate|0.55|||||TWO_SIDED|95.0|-0.66|2.33|||||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||2.33|-0.66|
73927632|NCT01888497|147383817|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|1.02||||0.134|TWO_SIDED|95.0|-0.39|2.51||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||2.51|-0.39|0.134
73927633|NCT01888497|147383817|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|2.37|||<|0.001|TWO_SIDED|95.0|1.01|3.98||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||3.98|1.01|<0.001
73927634|NCT01888497|147383818|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.36|||<|0.001|TWO_SIDED|95.0|0.26|0.47||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.47|0.26|<0.001
73927635|NCT01888497|147383818|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95% CI was 0.1 m/sec.|Hodges-Lehman estimate|-0.01|||||TWO_SIDED|95.0|-0.07|0.05|||||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.05|-0.07|
73927636|NCT01888497|147383818|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.07||||0.012|TWO_SIDED|95.0|0.02|0.12||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.12|0.02|0.012
73927637|NCT01888497|147383818|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.06||||0.014|TWO_SIDED|95.0|0.01|0.12||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.12|0.01|0.014
73927638|NCT01888497|147383819|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|103.25|||<|0.001|TWO_SIDED|95.0|72.0|130.5||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||130.50|72.00|<0.001
73927639|NCT01888497|147383819|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95% CI was 8 lanes.|Hodges-Lehman estimate|5.0|||||TWO_SIDED|95.0|-4.0|16.5|||||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||16.50|-4.00|
73927640|NCT01888497|147383819|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|3.0||||0.213|TWO_SIDED|95.0|-3.0|9.0||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||9.00|-3.00|0.213
73927641|NCT01888497|147383819|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|11.0||||0.003|TWO_SIDED|95.0|4.0|20.5||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||20.50|4.00|0.003
73927642|NCT03034954|147383823|OTHER|||||||0.3||||||Reported p-value represents Time (baseline to post-tDCS) x Condition (Active or Sham) interaction for all OLTT Accuracy Measures. If the multivariate statistic is not significant no univariate statistical analyses are completed.|Repeated Measures ANOVA|repeated measures (OLTT baseline and post-tDCS); between-subjects (active vs. sham)||We used a multivariate statistic to compare OLTT means (Free Recall Total Error, Free Recall Average Error, Cued Recall Total Error, Cued Recall Average Error, Recognition Total Correct) at baseline (Version B) to post HD-tDCS OLTT means (Version C), by groups (active vs. sham). The overall statistic represents the simultaneous comparison of baseline OLTT measures to post HD-tDCS OLTT measures.||||.300
74029393|NCT00227877|147613338|SUPERIORITY||Adjusted Relative Risk Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.5||0.78|TWO_SIDED|95.0|0.27|2.7|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.|||2.70|.27|.78
73927643|NCT03034954|147383825|OTHER|||||||0.044||||||Statistic represents the interaction between Time (baseline to post-tDCS) by Condition (Active vs. Sham).|Repeated Measures ANOVA|||A Repeated Measures ANOVA was used to compare baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham). The multivariate analyses included OLTT Response Times (i.e., Free Recall Average Response Time, Cued Recall Average Response Time, Recognition Average Response Time)||||.044
73927644|NCT03034954|147383825|OTHER|||||||0.006|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Free Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.006
73927645|NCT03034954|147383828|OTHER|||||||0.15|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Cued Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.15
73927646|NCT03034954|147383830|OTHER|||||||0.3|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Recognition Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.3
73927647|NCT03034954|147383835|OTHER|||||||0.45|||||||MANOVA|||A Multivariate ANOVA was used to compare Active vs. Sham groups on discriminability measures (i.e. 0-back d', 2-back d', semantic 2-back d') and calculated working memory measures (i.e., 2-back d' minus 0-back d', semantic 2-back d' minus 0-back d').||||.450
73927648|NCT03034954|147383836|OTHER|||||||0.078|||||||Chi-squared|||Chi-squared tests were conducted to determine group differences in actual condition assignment vs. estimated/perceived condition||||.078
73927649|NCT03034954|147383837|OTHER|||||||0.233|||||||Fisher Exact|||||||.233
73927650|NCT03034954|147383839|OTHER|||||||0.6|||||||Fisher Exact|||||||.600
73927651|NCT03034954|147383840|OTHER|||||||0.999|||||||Fisher Exact|||||||.999
73969657|NCT01073566|147479307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.8|-0.17|||ANOVA||Finesse versus usual injection device|This was conducted at a 2-sided alpha level of 0.05 and confidence intervals (CI) were calculated at 95%, 2-sided. A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.||-0.17|-0.80|0.004
73927652|NCT03034954|147383841|OTHER|||||||0.281|||||||Fisher Exact|||||||.281
73927653|NCT03034954|147383842|OTHER|||||||0.082|||||||Fisher Exact|||||||.082
73927654|NCT03034954|147383843|OTHER|||||||0.49|||||||Fisher Exact|||||||.490
73927655|NCT03034954|147383844|OTHER|||||||0.488|||||||Fisher Exact|||||||.488
73927656|NCT03034954|147383845|OTHER|||||||0.219|||||||Fisher Exact|||||||.219
73927657|NCT02431754|147383847|SUPERIORITY_OR_OTHER|||||||0.0937|||||||Normal approximation (Z-test)|||||||0.0937
73927658|NCT02431754|147383848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.1485|TWO_SIDED|95.0|-1.69|0.26|||Mixed Models Analysis|||||0.26|-1.69|0.1485
73927659|NCT01218516|147383866|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.3519|TWO_SIDED|80.0|0.92|1.63||Per Primary Analysis Cut-Off Date|Log Rank|||||1.63|0.92|0.3519
73969658|NCT01073566|147479308|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||Higher number is better. The answers were scored on a scale of 0-100 to standardize as described in the original papers.||||<0.001
73927660|NCT01218516|147383866|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.34||||0.1555|TWO_SIDED|80.0|1.03|1.74||Per Final Analysis Cut-Off Date|Log Rank|||||1.74|1.03|0.1555
73927661|NCT01714310|147383877|SUPERIORITY|||||||0.58||||||Group: F=.31, df=1/140|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.58
73927662|NCT01714310|147383877|SUPERIORITY|||||||0.85||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.03, df=1/140||||||.85
73927663|NCT01714310|147383877|SUPERIORITY|||||||0.26||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=1.28, df=1/140||||||.26
73927664|NCT01714310|147383878|SUPERIORITY|||||||0.97||||||Group: F=0.00, df=1/44|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).||||||.97
73927665|NCT01714310|147383878|SUPERIORITY||||||<|0.0002||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=136.22, df=1/44||||||<.0002
73927666|NCT01714310|147383878|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=64.90, df=1/44||||||<.0001
73927667|NCT01714310|147383879|SUPERIORITY||||||<|0.0001||||||Time: F=41.85, df=1/89, p\<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
73927668|NCT01714310|147383880|SUPERIORITY||||||<|0.0001||||||Time: F=26.65, df=1/92, p \<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
73927669|NCT01714310|147383881|SUPERIORITY||||||<|0.0001||||||Time: F=40.35, df=1/89, p \< .0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
73927670|NCT01714310|147383882|SUPERIORITY||||||<|0.0001||||||Time: F=26.36, df=1/29, p \<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
73927671|NCT01714310|147383883|SUPERIORITY|||||||0.44||||||Group: F=.60, df=1/157|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.44
73927672|NCT01714310|147383883|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=22.39, df=1/157||||||<.0001
73927673|NCT01714310|147383883|SUPERIORITY|||||||0.04||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=4.40, df=1/157||||||.04
73969659|NCT01389856|147479315|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
73969660|NCT01389856|147479316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3407|TWO_SIDED||||||Log Rank|||||||0.3407
73927674|NCT01714310|147383884|SUPERIORITY|||||||0.05||||||Group: F=3.81, df=1/145|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||No significant group\*time interactions. Group trend likely due to baseline differences.|||.05
73927675|NCT01714310|147383884|SUPERIORITY|||||||0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Tie: F=15.28, df=1/145||||||.0001
73927676|NCT01714310|147383884|SUPERIORITY|||||||0.02||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=5.42, df=1/145||||||.02
73927677|NCT01714310|147383885|SUPERIORITY|||||||0.76|||||||Chi-squared|Chi Square = .10, df=1, p=.76||||||.76
73927678|NCT01714310|147383886|SUPERIORITY|||||||0.38||||||Group: F=.78, df=1/220|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).||||||.38
73927679|NCT01714310|147383886|SUPERIORITY|||||||0.42||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.66, df=1/220||||||.42
73927680|NCT01714310|147383886|SUPERIORITY|||||||0.13||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.66, df=1/220||||||.13
73927681|NCT01714310|147383887|SUPERIORITY|||||||0.21||||||Group: F=1.56, df=1/222|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.21
73927682|NCT01714310|147383887|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=63.11, df=1/222||||||<.0001
73927683|NCT01714310|147383887|SUPERIORITY|||||||0.0004||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=12.86, df=1/222||||||.0004
73927684|NCT01714310|147383888|SUPERIORITY|||||||0.02||||||Group: F=5.42, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.02
73969661|NCT01389856|147479317|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2399|TWO_SIDED||||||Log Rank|||||||0.2399
73927685|NCT01714310|147383888|SUPERIORITY|||||||0.18||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.77, df=1/223||||||.18
73927686|NCT01714310|147383888|SUPERIORITY|||||||0.49||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.47, df=1/223||||||.49
73927687|NCT01714310|147383889|SUPERIORITY|||||||0.9||||||Group: F=.02, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.90
73927688|NCT01714310|147383889|SUPERIORITY|||||||0.21||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.60, df=1/223||||||.21
73927689|NCT01714310|147383889|SUPERIORITY|||||||0.73||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.12, df=1/223||||||.73
73927690|NCT01714310|147383890|SUPERIORITY|||||||0.15||||||Group: F=2.05, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.15
73927691|NCT01714310|147383890|SUPERIORITY|||||||0.59||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.29, df=1/223||||||.59
73927692|NCT01714310|147383890|SUPERIORITY|||||||0.14||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=2.15, df=1/223||||||.14
73927693|NCT02822508|147383894|SUPERIORITY|||||||0.034|||||||Cochran-Mantel-Haenszel|||||||0.034
73927694|NCT01604343|147383900|SUPERIORITY_OR_OTHER||Percentage Difference|28.4|||<|0.001|TWO_SIDED|95.0|22.8|33.8|||Cochran-Mantel-Haenszel|||||33.8|22.8|< 0.001
73927695|NCT01604343|147383900|SUPERIORITY_OR_OTHER||Percentage Difference|27.1|||<|0.001|TWO_SIDED|95.0|21.6|32.6|||Cochran-Mantel-Haenszel|||||32.6|21.6|< 0.001
73927696|NCT01604343|147383901|SUPERIORITY_OR_OTHER||||||<|0.001|||||||van der waerden ANOVA|||||||< 0.001
73927697|NCT01604343|147383901|SUPERIORITY_OR_OTHER||||||<|0.001|||||||van der waerden ANOVA|||||||< 0.001
73927698|NCT01604343|147383902|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.226|||<|0.001|TWO_SIDED|95.0|-0.29|-0.17|||ANCOVA|||||-0.17|-0.29|<0.001
73927699|NCT01604343|147383902|SUPERIORITY_OR_OTHER||LS mean difference|-0.256|||<|0.001|TWO_SIDED|95.0|-0.32|-0.2|||ANCOVA|||||-0.20|-0.32|<0.001
73927700|NCT01604343|147383903|SUPERIORITY_OR_OTHER||Percentage Difference|17.8|||<|0.001|TWO_SIDED|95.0|13.1|22.4|||Cochran-Mantel-Haenszel|||||22.4|13.1|< 0.001
73927701|NCT01604343|147383903|SUPERIORITY_OR_OTHER||Percentage Difference|20.8|||<|0.001|TWO_SIDED|95.0|16.1|25.6|||Cochran-Mantel-Haenszel|||||25.6|16.1|< 0.001
73927702|NCT01604343|147383904|SUPERIORITY_OR_OTHER||Percentage Difference|20.5|||<|0.001|TWO_SIDED|95.0|16.4|24.6|||Cochran-Mantel-Haenszel|||||24.6|16.4|< 0.001
73927703|NCT01604343|147383904|SUPERIORITY_OR_OTHER||Percentage Difference|19.9|||<|0.001|TWO_SIDED|95.0|15.8|24.0|||Cochran-Mantel-Haenszel|||||24.0|15.8|< 0.001
73927704|NCT01604343|147383905|SUPERIORITY_OR_OTHER||Percentage Difference|3.6||||0.001|TWO_SIDED|95.0|1.4|5.8|||Cochran-Mantel-Haenszel|||||5.8|1.4|0.001
73927705|NCT01604343|147383905|SUPERIORITY_OR_OTHER||Percentage Difference|7.2|||<|0.001|TWO_SIDED|95.0|4.6|9.8|||Cochran-Mantel-Haenszel|||||9.8|4.6|< 0.001
73969662|NCT01389856|147479319|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
73969663|NCT01389856|147479320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2235|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.2235
73969664|NCT01389856|147479321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1468|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1468
73927706|NCT04998136|147383936|SUPERIORITY||Treatment difference|-12.99|||<|0.0001|TWO_SIDED|95.0|-15.28|-10.7|||ANCOVA|||Treatment policy Estimand. The primary endpoint was analysed using an analysis of covariance (ANCOVA) model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial observation period.||-10.70|-15.28|<0.0001
73927707|NCT04998136|147383937|SUPERIORITY||Treatment Difference|-13.4|||<|0.0001|TWO_SIDED|95.0|-15.7|-11.11|||MMRM|||Hypothetical Estimand. The primary endpoint was analysed using mixed model for repeated measurements (MMRM). All responses prior to first discontinuation of treatment (or dose reduction, or initiation of other anti-obesity medication or bariatric surgery) were included in MMRM with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.||-11.11|-15.70|<0.0001
73927708|NCT04998136|147383938|SUPERIORITY||Odds Ratio (OR)|88.87|||<|0.0001|TWO_SIDED|95.0|21.96|359.61|||Regression, Logistic|||Treatment policy estimand. The primary endpoint was analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial period.||359.61|21.96|<0.0001
73927709|NCT04998136|147383939|SUPERIORITY||Odds Ratio (OR)|253.47|||<|0.0001|TWO_SIDED|95.0|38.41|1672.57|||Regression, Logistic|||Hypothetical estimand. MMRM was used with randomized treatment as factor and baseline body weight as covariate. The MMRM was performed on body weight (kg) and individual missing week 44 responses were predicted from the MMRM, each participant was then classified for body weight loss \>= 5% and analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.||1672.57|38.41|<0.0001
73927710|NCT03754959|147383976|OTHER||Ratio|97.9|||||TWO_SIDED|90.0|90.2|106.2|||||Ratio is calculated with Placebo+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.2|90.2|
73927711|NCT03754959|147383976|OTHER||Ratio|95.9|||||TWO_SIDED|90.0|89.9|102.4|||||Ratio is calculated with BI 1358894 10 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|||102.4|89.9|
73927712|NCT03754959|147383976|OTHER||Ratio|101.0|||||TWO_SIDED|90.0|96.3|106.1|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.1|96.3|
73927713|NCT03754959|147383976|OTHER||Ratio|93.7|||||TWO_SIDED|90.0|86.8|101.1|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||101.1|86.8|
73927714|NCT03754959|147383976|OTHER||Ratio|93.1|||||TWO_SIDED|90.0|87.3|99.3|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||99.3|87.3|
73927715|NCT03754959|147383976|OTHER||Ratio|90.0|||||TWO_SIDED|90.0|83.8|96.7|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||96.7|83.8|
73927716|NCT03754959|147383977|OTHER||Ratio|105.7|||||TWO_SIDED|90.0|95.6|116.9|||||Ratio is calculated with Placebo+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||116.9|95.6|
74087994|NCT01682148|147729881|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.6052|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.6052
73927717|NCT03754959|147383977|OTHER||Ratio|117.5|||||TWO_SIDED|90.0|106.5|129.6|||||Ratio is calculated with BI 1358894 10 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||129.6|106.5|
73927718|NCT03754959|147383977|OTHER||Ratio|112.6|||||TWO_SIDED|90.0|102.9|123.1|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||123.1|102.9|
73969665|NCT01389856|147479322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0789|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0789
73969666|NCT01389856|147479323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3723|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3723
73969667|NCT01389856|147479324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0569|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0569
73927719|NCT03754959|147383977|OTHER||Ratio|110.3|||||TWO_SIDED|90.0|90.1|135.1|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||135.1|90.1|
73927720|NCT03754959|147383977|OTHER||Ratio|96.4|||||TWO_SIDED|90.0|84.5|110.1|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||110.1|84.5|
73927721|NCT03754959|147383977|OTHER||Ratio|89.3|||||TWO_SIDED|90.0|74.9|106.4|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.4|74.9|
73927722|NCT03754959|147383978|OTHER||Ratio|98.3|||||TWO_SIDED|90.0|84.2|114.8|||||Ratio is calculated with Placebo+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||114.8|84.2|
73927723|NCT03754959|147383978|OTHER||Ratio|98.0|||||TWO_SIDED|90.0|87.9|109.3|||||Ratio is calculated with BI 1358894 10mg +Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||109.3|87.9|
73927724|NCT03754959|147383978|OTHER||Ratio|117.5|||||TWO_SIDED|90.0|102.6|134.6|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||134.6|102.6|
73927725|NCT03754959|147383978|OTHER||Ratio|94.5|||||TWO_SIDED|90.0|85.5|104.4|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||104.4|85.5|
73927726|NCT03754959|147383978|OTHER||Ratio|98.2|||||TWO_SIDED|90.0|87.3|99.3|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||99.3|87.3|
73927727|NCT03754959|147383978|OTHER||Ratio|98.0|||||TWO_SIDED|90.0|84.3|114.0|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||114.0|84.3|
73927728|NCT03754959|147383979|OTHER||Ratio|95.5|||||TWO_SIDED|90.0|81.3|112.1|||||Ratio is calculated with Placebo+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||112.1|81.3|
73927729|NCT03754959|147383979|OTHER||Ratio|105.7|||||TWO_SIDED|90.0|91.5|122.0|||||Ratio is calculated with BI 1358894 10mg +Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||122.0|91.5|
73927730|NCT03754959|147383979|OTHER||Ratio|116.3|||||TWO_SIDED|90.0|90.9|148.7|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||148.7|90.9|
73927731|NCT03754959|147383979|OTHER||Ratio|106.8|||||TWO_SIDED|90.0|92.4|123.4|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||123.4|92.4|
73969668|NCT01389856|147479325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1015|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1015
73969669|NCT01389856|147479326|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0824|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0824
73969670|NCT01389856|147479327|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3863|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3863
73969671|NCT01389856|147479328|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3936|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3936
73969672|NCT01389856|147479329|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2436|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.2436
73969673|NCT01389856|147479330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1756|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1756
73969674|NCT01389856|147479331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1155|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1155
73969675|NCT01389856|147479332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1400
73927732|NCT03754959|147383979|OTHER||Ratio|83.9|||||TWO_SIDED|90.0|71.2|98.9|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||98.9|71.2|
73927733|NCT03754959|147383979|OTHER||Ratio|87.2|||||TWO_SIDED|90.0|73.5|103.5|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||103.5|73.5|
73927734|NCT03144180|147383989|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.|Confidence Interval for a mean|49.0|STANDARD_DEVIATION|47.0|||TWO_SIDED|95.0|15.459|82.571||||||||82.571|15.459|
73927735|NCT03144180|147383990|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.0295||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||0.0295
73927736|NCT03144180|147383991|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.403||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||0.403
73927737|NCT03663283|147383992|SUPERIORITY|||||||0.0197|||||||Wilcoxon (Mann-Whitney)|||||||.0197
73927738|NCT03663283|147383993|SUPERIORITY|||||||0.584|||||||Wilcoxon (Mann-Whitney)|||72 hours||||0.584
73927739|NCT03663283|147383993|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||3 weeks||||.5800
73927740|NCT03663283|147383994|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
73927741|NCT03663283|147383995|SUPERIORITY|||||||0.7018|||||||Wilcoxon (Mann-Whitney)|||72 hours||||.7018
73927742|NCT03663283|147383995|SUPERIORITY|||||||0.5327|||||||Wilcoxon (Mann-Whitney)|||Week 3||||.5327
73927743|NCT00606892|147384005|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Significant treatment or treatment-by-time interactions were followed up by post hoc comparisons of placebo vs. varenicline for time (Pre- vs. Post-Nicotine infusion) and testing block (Smoking Block vs. Negative Affect Block).|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model with fixed main effect terms of treatment (placebo or varenicline) and time of measurement (Pre-Nicotine or Post-Nicotine) was utilized. Interactions between main effect terms were also analyzed.||||<0.05
73927744|NCT00606892|147384006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_DEVIATION|40.0|<|0.3|TWO_SIDED|95.0|||||ANOVA|F(1,10)=1.1||||||<0.3
73927745|NCT00606892|147384007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0||||Values of p\<0.05 were considered statistically significant, based on 2-tailed tests. Significant treatment, or treatment-by-time interactions were followed by post hoc comparisons. To account for multiple testing, significance was set at p\<0.016.|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model including fixed main effects for treatment condition (placebo or varenicline), time of measurement and interactions between treatment and time, was utilized. Because multiple measurements were collected before and after each nicotine dose, a change score (maximum post dose score - pre dose baseline) was used in the analysis.||||<0.05
73927746|NCT00606892|147384008|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Post hoc comparisons of effects of varenicline versus placebo for different nicotine doses were performed and significance was adjusted for multiple testing using a p value of P\<0.016|ANOVA|Two-tailed tests were applied for main effects with P\<0.05||A mixed-effect, repeated-measures, crossover model was used with fixed main effects for treatment (placebo or varenicline), and time after treatment. Interactions between main effects were also analyzed.||||<0.05
73927747|NCT04753164|147384045|OTHER|Mixed effects model for Repeated Measures: Change from baseline in the number of BE days per week = baseline number of BE days per week + sex (Male; Female) + BMI group (\< 30 ; ≥ 30 kg/m2) + treatment + visit + treatment × visit + baseline × visit.|LS Mean Difference to Placebo|0.0||||0.9992|TWO_SIDED|95.0|-0.69|0.69|||Mixed effects model f. repeated measures|||||0.69|-0.69|0.9992
73927748|NCT04180020|147384115|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
73927749|NCT00405548|147384132|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73927750|NCT00405548|147384133|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
73927751|NCT00405548|147384134|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73927752|NCT00405548|147384135|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the BNP group.||||0.004
73927753|NCT00405548|147384135|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the Placebo group.||||0.43
73927754|NCT00811577|147384159|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.57
73969676|NCT05604508|147479351|OTHER||Odds Ratio (OR)|0.735|||||TWO_SIDED|95.0|0.347|1.553|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline cigarette use intentions|||1.553|0.347|
73969677|NCT05604508|147479351|OTHER||Odds Ratio (OR)|0.471|||||TWO_SIDED|95.0|0.234|0.947|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline cigarette use intentions.|||0.947|0.234|
73927755|NCT00811577|147384159|SUPERIORITY_OR_OTHER|||||||0.56||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.56
73927756|NCT00811577|147384159|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.61
73927757|NCT00811577|147384159|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.80
73927758|NCT00811577|147384160|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.47
73927759|NCT00811577|147384160|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.080
73927760|NCT00811577|147384160|SUPERIORITY_OR_OTHER|||||||0.96||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.96
73927761|NCT00811577|147384160|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.22
73927762|NCT00811577|147384161|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.87
73969678|NCT05604508|147479352|OTHER||Odds Ratio (OR)|1.503|||||TWO_SIDED|95.0|0.727|3.107|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline vaping intentions|||3.107|0.727|
73969679|NCT05604508|147479352|OTHER||Odds Ratio (OR)|0.878|||||TWO_SIDED|95.0|0.398|1.938|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline vaping intentions|||1.938|0.398|
73927763|NCT00811577|147384161|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.15
73927764|NCT00811577|147384161|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.77
73969680|NCT05604508|147479353|OTHER||Odds Ratio (OR)|0.619|||||TWO_SIDED|95.0|0.295|1.301|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline smokeless use intentions|||1.301|0.295|
73969681|NCT05604508|147479353|OTHER||Odds Ratio (OR)|0.489|||||TWO_SIDED|95.0|0.237|1.006|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco, baseline smokeless use intentions|||1.006|0.237|
73969682|NCT05604508|147479354|OTHER||Odds Ratio (OR)|1.428|||||TWO_SIDED|95.0|0.72|2.832|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline LCC use intentions|||2.832|0.720|
73969683|NCT05604508|147479354|OTHER||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.681|2.96|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline LCC use intentions|||2.960|0.681|
73969684|NCT04971681|147479400|SUPERIORITY||||||<|0.27|||||||t-test, 2 sided|||||||<0.27
73969685|NCT04971681|147479401|SUPERIORITY||||||<|0.1|||||||t-test, 2 sided|||||||<0.10
73969686|NCT00686335|147479402|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_DEVIATION|6.07|||TWO_SIDED|95.0|-13.5|-2.2||As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.|Other|As this was an explorative study, no hypothesis testing was performed. All analyses were descriptive.||As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.||-2.2|-13.5|
73969687|NCT01743807|147479420|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73969688|NCT03344094|147479467|OTHER|changes in subsets paired and unpaired t-tests, ANOVA||||||0.05|||||||ANOVA|||||||0.05
73927765|NCT00811577|147384161|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.75
73927766|NCT00811577|147384161|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.050
73927767|NCT00811577|147384161|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.83
73927768|NCT00811577|147384161|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.37
73927769|NCT00811577|147384161|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.43
73927770|NCT00811577|147384162|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.16
73927771|NCT00811577|147384162|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.14
74087995|NCT01682148|147729881|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.5369|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.5369
73927772|NCT00811577|147384162|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.69
73927773|NCT00811577|147384162|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.89
73927774|NCT00811577|147384162|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.30
73927775|NCT00811577|147384162|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.46
73927776|NCT00811577|147384163|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.086
73927777|NCT00811577|147384163|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.66
74029394|NCT00227877|147613339|SUPERIORITY||Adjusted Relative Risk Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.15||0.13|TWO_SIDED|95.0|0.51|1.09|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.|||1.09|.51|.13
74029395|NCT00227877|147613340|SUPERIORITY||Adjusted Relative Risk Ratio|0.66|STANDARD_ERROR_OF_MEAN|0.11||0.66|TWO_SIDED|95.0|0.48|0.91|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.|||.91|.48|.66
74029396|NCT00227877|147613341|SUPERIORITY||Adjusted Relative Risk Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.35|TWO_SIDED|95.0|0.64|1.17||Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.|||1.17|.64|.35
73969689|NCT03808818|147479470|EQUIVALENCE|the smallest detectable difference will be 22%|Odds Ratio (OR)|2.3||||0.0046|TWO_SIDED|95.0|1.28|4.13||No correction for multiple comparisons|Chi-squared|||"For self-reported 7-day point prevalence abstinence at 6-months, with a sample size of 140 in each arm then smallest detectable difference will be 22% with 80% power. Subsequent analyses will use a Bonferroni corrected alpha of 0.002 using with an estimated control rate of 31%.~The primary analysis will be performed from an intent-to-treat perspective. Chi-square tests will be used to compare the outcomes between treatment groups."||4.13|1.28|0.0046
73969690|NCT03808818|147479471|EQUIVALENCE|the smallest detectable difference will be 22% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 28%.|Odds Ratio (OR)|1.86||||0.035|TWO_SIDED|95.0|1.04|3.33|||Chi-squared|||7-day point prevalence abstinence at 3-months, with a sample size of 140 in each arm then smallest detectable difference will be 18% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 20%||3.33|1.04|0.035
73927778|NCT00811577|147384163|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.069
73969691|NCT03808818|147479472|EQUIVALENCE|the smallest detectable difference will be 21% with 80% power and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%.||||||0.016|||||||Chi-squared|||power calculations assumed a sample size of 140 in each arm and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%||||0.016
73969692|NCT03808818|147479474|EQUIVALENCE|no margin||||||0.069|||||||Chi-squared|||||||0.069
73969693|NCT03808818|147479475|EQUIVALENCE|no margin||||||0.86|||||||Chi-squared|||||||0.86
73969694|NCT03808818|147479487|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
73969695|NCT03808818|147479488|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
73927779|NCT00811577|147384163|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.68
73927780|NCT00811577|147384163|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.095
73927781|NCT00811577|147384163|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.62
73927782|NCT00811577|147384164|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject's gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.||||0.44
73927783|NCT00811577|147384164|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject's gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.||||0.41
73927784|NCT02442778|147384171|SUPERIORITY||Least Squares (LS) Mean Difference|0.4||||0.789|TWO_SIDED|95.0|-2.7|3.5||MMRM included fixed effect treatment,visit,treatment-by-visit,baseline,baseline-by-visit,baseline Neuropsychiatric Inventory Agitation/Aggression(NPI AA)(≤6 vs. \>6),falls risk assessment,baseline concomitant use of antipsychotic medications,cohorts.|MMRM|||||3.5|-2.7|0.789
73969696|NCT03808818|147479489|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
73969697|NCT03808818|147479491|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
73969698|NCT05415722|147479497|SUPERIORITY||Mean Difference (Final Values)|-11.39|STANDARD_ERROR_OF_MEAN|7.48||0.1303|TWO_SIDED|95.0|-26.178|3.406|||ANCOVA|||Arm 1 compared to Placebo||3.406|-26.178|0.1303
73969699|NCT05415722|147479497|SUPERIORITY||Mean Difference (Final Values)|-23.47|STANDARD_ERROR_OF_MEAN|7.924||0.0036|TWO_SIDED|95.0|-39.14|-7.799|||ANCOVA|||Arm 2 compared to Placebo||-7.799|-39.140|0.0036
73969700|NCT05415722|147479497|SUPERIORITY||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|7.96|<|0.0001|TWO_SIDED|95.0|-56.545|-25.064|||ANCOVA|||Arm 3 compared to Placebo||-25.064|-56.545|<0.0001
73969701|NCT05415722|147479498|SUPERIORITY||Mean Difference (Final Values)|-31.9|STANDARD_ERROR_OF_MEAN|20.87||0.1289|TWO_SIDED|95.0|-73.17|9.39|||ANCOVA|||Arm 1 compared to Placebo||9.39|-73.17|0.1289
73969702|NCT05415722|147479498|SUPERIORITY||Mean Difference (Final Values)|-29.3|STANDARD_ERROR_OF_MEAN|21.65||0.179|TWO_SIDED|95.0|-72.08|13.58|||ANCOVA|||Arm 2 compared to Placebo||13.58|-72.08|0.1790
73969703|NCT05415722|147479498|SUPERIORITY||Mean Difference (Final Values)|-75.7|STANDARD_ERROR_OF_MEAN|21.96||0.0008|TWO_SIDED|95.0|-119.08|-32.23|||ANCOVA|||Arm 3 compared to Placebo||-32.23|-119.08|0.0008
73969704|NCT05415722|147479499|SUPERIORITY||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|7.895||0.0358|TWO_SIDED|95.0|-32.352|-1.128|||ANCOVA|||Arm 4 compared to Placebo||-1.128|-32.352|0.0358
73969705|NCT05415722|147479499|SUPERIORITY||Mean Difference (Final Values)|-43.73|STANDARD_ERROR_OF_MEAN|7.647|<|0.0001|TWO_SIDED|95.0|-58.858|-28.612|||ANCOVA|||Arm 5 compared to Placebo||-28.612|-58.858|<0.0001
73969706|NCT05415722|147479500|SUPERIORITY||Mean Difference (Final Values)|-62.6|STANDARD_ERROR_OF_MEAN|22.09||0.0053|TWO_SIDED|95.0|-106.33|-18.96|||ANCOVA|||Arm 4 compared to Placebo||-18.96|-106.33|0.0053
73969707|NCT05415722|147479500|SUPERIORITY||Mean Difference (Final Values)|-69.2|STANDARD_ERROR_OF_MEAN|21.13||0.0014|TWO_SIDED|95.0|-110.97|-27.39|||ANCOVA|||Arm 5 compared to Placebo||-27.39|-110.97|0.0014
73969708|NCT03031470|147479566|SUPERIORITY|||||||0.688|||||||Fisher Exact|Analysis is based on exact Fisher test to compare treatments.||||||0.688
73969709|NCT03031470|147479567|SUPERIORITY|||||||0.7|||||||Fisher Exact|Analysis is based on exact Fisher test to compare treatments.||||||0.700
73969710|NCT03031470|147479568|SUPERIORITY||||||>|0.999|||||||Fisher Exact|Treatment groups were compared for frequency of allograft nonfunction using Fisher exact test||||||>0.999
73969711|NCT03031470|147479569|SUPERIORITY|||||||0.308|||||||Fisher Exact|||||||0.308
73969712|NCT03031470|147479570|SUPERIORITY|||||||0.601|||||||Fisher Exact|||||||0.601
73969713|NCT03031470|147479572|SUPERIORITY|||||||0.574|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for degree of allograft steatosis using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.574
73969714|NCT03031470|147479573|SUPERIORITY|||||||0.843|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for duration of cold ischemia using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.843
73969715|NCT03031470|147479574|SUPERIORITY|||||||0.701|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for duration of earm ischemia using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.701
73969716|NCT03031470|147479584|SUPERIORITY|"General survival and graft survival (graft loss will be qualified as an event for graft survival) within 1 year were presented with Kaplan-Mayer curves and survival time median with 95% CI. Treatment groups will be compared using logrank test."||||||0.416|||||||Log Rank|||||||0.416
73969717|NCT03461276|147479588|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|A 1-sided t-test with a significance level of 0.025 was employed.||"The trial was considered successfully confirmatory regarding efficacy (immunogenicity) of ABvac40 if the average MΔ of anti-Aβ40 antibody signal (OD in ELISA) in the ABvac40 group was significantly greater than the average MΔ of anti-Aβ40 antibody signal in the Placebo group. i.e.~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) ≤ average MΔ anti-Aβ40 (placebo).~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) \> average MΔ anti-Aβ40 (placebo)."||||<0.0001
73969718|NCT03461276|147479588|SUPERIORITY|Additional test|||||<|0.0001||||||1-sided|Wilcoxon (Mann-Whitney)|||||||<0.0001
73969719|NCT03461276|147479588|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|2.96|3.34|||ANCOVA|||The average MΔ of anti-Aβ40 antibody signal between the two treatment groups was compared using an ANCOVA model, using the MΔ anti-Aβ40 antibody signal as the dependent variable, baseline anti-Aβ40 antibody signal (OD in ELISA) as covariate and treatment group and amyloid positivity as fixed effects.||3.34|2.96|<0.0001
73969720|NCT03461276|147479588|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|t-test (sensitivity hypothesis). A 1-sided t-test with a significance level of 0.025 was employed.||"1-sided t-test to compare the ABvac40 and placebo groups.~The primary analysis (t-test) was repeated, using the mITT Analysis Set to test the hypothesis:~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) - average MΔ anti-Aβ40 (placebo) ≤ 1.778~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) - average MΔ anti-Aβ40 (placebo) \> 1.778 The alternative hypothesis was confirmed."||||<0.0001
73969721|NCT03461276|147479588|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||"The change in anti-Aβ40 antibody signal from baseline to each post-baseline efficacy visit was analyzed using a Mixed-Model Repeated Measures (MMRM), using the mITT Analysis Set.~Dependent variable: change from baseline in anti-Aβ40 antibody signal. Fixed effects: treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity. Covariates: baseline anti-Aβ40 antibody signal and baseline age; Repeated measure: measures within-patient at each visit."||||<0.05
73969722|NCT03461276|147479595|OTHER||||||<|0.001|||||||Mixed Models Analysis|||MMRM - Week 50A||||<0.001
73969723|NCT03461276|147479595|OTHER||||||=|0.047|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.047
73969724|NCT03461276|147479596|OTHER||||||=|0.9936|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9936
73969725|NCT03461276|147479596|OTHER||||||=|0.0391||||||MMRM - Week 6A|Mixed Models Analysis|||MMRM - Week 6A||||= 0.0391
73969726|NCT03461276|147479596|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 10A||||< 0.0001
73969727|NCT03461276|147479596|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 14A||||< 0.0001
73969728|NCT03461276|147479596|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 18A||||< 0.0001
73969729|NCT03461276|147479596|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 24A||||< 0.0001
73969730|NCT03461276|147479596|OTHER||||||=|0.0299|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0299
73969731|NCT03461276|147479596|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
73969732|NCT03461276|147479596|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
73969733|NCT03461276|147479596|OTHER||||||=|0.1267|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1267
73969734|NCT03461276|147479596|OTHER|MMRM - Week 104A|||||=|0.2477|||||||Mixed Models Analysis|||||||= 0.2477
73969735|NCT03461276|147479597|OTHER||||||=|0.2151|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.2151
73969736|NCT03461276|147479597|OTHER||||||=|0.0169|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.0169
73969737|NCT03461276|147479597|OTHER||||||=|0.0008|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.0008
73969738|NCT03461276|147479597|OTHER||||||=|0.0002|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0002
73969739|NCT03461276|147479597|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 18A||||< 0.0001
73969740|NCT03461276|147479597|OTHER||||||=|0.0023|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.0023
73969741|NCT03461276|147479597|OTHER||||||=|0.0021|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0021
73969742|NCT03461276|147479597|OTHER||||||=|0.0007|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.0007
73969743|NCT03461276|147479597|OTHER||||||=|0.0012|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.0012
73969744|NCT03461276|147479597|OTHER||||||=|0.0018|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.0018
73969745|NCT03461276|147479597|OTHER||||||=|0.738|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.738
73969746|NCT03461276|147479598|OTHER||||||=|0.7623|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.7623
73969747|NCT03461276|147479598|OTHER||||||=|0.1506|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.1506
73969748|NCT03461276|147479598|OTHER||||||=|0.1071|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.1071
73969749|NCT03461276|147479598|OTHER||||||=|0.0212|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0212
73862703|NCT04332614|147271283|SUPERIORITY||Odds Ratio (OR)|1.6914929||||0.0127|TWO_SIDED|95.0|1.1762411|2.43245||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.432450|1.1762411|0.0127
73927785|NCT02442778|147384171|SUPERIORITY||LS Mean Difference|-2.0||||0.2|TWO_SIDED|95.0|-5.0|1.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.0|-5.0|0.200
73927786|NCT02442778|147384172|SUPERIORITY||LS Mean Difference|0.1||||0.484|TWO_SIDED|95.0|-0.2|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.2|0.484
73927787|NCT02442778|147384172|SUPERIORITY||LS Mean Difference|-0.1||||0.704|TWO_SIDED|95.0|-0.3|0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.2|-0.3|0.704
73927788|NCT02442778|147384173|SUPERIORITY||LS Mean Difference|-0.3||||0.416|TWO_SIDED|95.0|-0.9|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.9|0.416
73927789|NCT02442778|147384173|SUPERIORITY||LS Mean Difference|-0.6||||0.066|TWO_SIDED|95.0|-1.3|0.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.0|-1.3|0.066
73927790|NCT02442778|147384174|SUPERIORITY||LS Mean Difference|-0.2||||0.249|TWO_SIDED|95.0|-0.5|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.5|0.249
73862704|NCT04332614|147271283|SUPERIORITY||Odds Ratio (OR)|1.8608951||||0.0033|TWO_SIDED|95.0|1.2800275|2.705356||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.705356|1.2800275|0.0033
73927791|NCT02442778|147384174|SUPERIORITY||LS Mean Difference|-0.2||||0.199|TWO_SIDED|95.0|-0.5|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.5|0.199
73927792|NCT02442778|147384175|SUPERIORITY||LS Mean Difference|0.0||||0.975|TWO_SIDED|95.0|-0.7|0.7||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.7|-0.7|0.975
73927793|NCT02442778|147384175|SUPERIORITY||LS Mean Difference|-0.3||||0.334|TWO_SIDED|95.0|-1.0|0.3||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.3|-1.0|0.334
73927794|NCT02442778|147384176|SUPERIORITY||LS Mean Difference|-0.1||||0.934|TWO_SIDED|95.0|-2.4|2.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.2|-2.4|0.934
73927795|NCT02442778|147384176|SUPERIORITY||LS Mean Difference|1.1||||0.342|TWO_SIDED|95.0|-1.2|3.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||3.4|-1.2|0.342
73927796|NCT02442778|147384177|SUPERIORITY||LS Mean Difference|0.0||||0.888|TWO_SIDED|95.0|-0.7|0.6||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.6|-0.7|0.888
73927797|NCT02442778|147384177|SUPERIORITY||LS Mean Difference|-0.7||||0.019|TWO_SIDED|95.0|-1.3|-0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||-0.1|-1.3|0.019
73927798|NCT02442778|147384178|SUPERIORITY||LS Mean Difference|0.6||||0.756|TWO_SIDED|95.0|-2.9|4.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||4.0|-2.9|0.756
73927799|NCT02442778|147384178|SUPERIORITY||LS Mean Difference|-3.6||||0.038|TWO_SIDED|95.0|-7.0|-0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||-0.2|-7.0|0.038
73927800|NCT02442778|147384179|SUPERIORITY||LS Mean Difference|-0.1||||0.468|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.468
73927801|NCT02442778|147384179|SUPERIORITY||LS Mean Difference|-0.1||||0.158|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.158
73927802|NCT02442778|147384180|SUPERIORITY||LS Mean Difference|0.1||||0.4|TWO_SIDED|95.0|-0.2|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.2|0.400
73969750|NCT03461276|147479598|OTHER||||||=|0.0014|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.0014
73969751|NCT03461276|147479598|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 24A||||< 0.0001
73969752|NCT03461276|147479598|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 40A||||< 0.0001
73927803|NCT02442778|147384180|SUPERIORITY||LS Mean Difference|-0.1||||0.566|TWO_SIDED|95.0|-0.3|0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.2|-0.3|0.566
73969753|NCT03461276|147479598|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
73927804|NCT02442778|147384181|SUPERIORITY||LS Mean Difference|0.0||||0.751|TWO_SIDED|95.0|-0.2|0.3||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.3|-0.2|0.751
73927805|NCT02442778|147384181|SUPERIORITY||LS Mean Difference|-0.1||||0.32|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.320
73927806|NCT02442778|147384182|SUPERIORITY||LS Mean Difference|0.3||||0.782|TWO_SIDED|95.0|-1.8|2.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.4|-1.8|0.782
73927807|NCT02442778|147384182|SUPERIORITY||LS Mean Difference|0.0||||0.991|TWO_SIDED|95.0|-2.1|2.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.0|-2.1|0.991
73927808|NCT02442778|147384183|SUPERIORITY||LS Mean Difference|0.6||||0.038|TWO_SIDED|95.0|0.0|1.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.2|0.0|0.038
73927809|NCT02442778|147384183|SUPERIORITY||LS Mean Difference|0.0||||0.911|TWO_SIDED|95.0|-0.6|0.5||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.5|-0.6|0.911
73969754|NCT03461276|147479598|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
73969755|NCT03461276|147479598|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 77A||||< 0.0001
73969756|NCT03461276|147479598|OTHER||||||=|0.0251|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0251
73969757|NCT03461276|147479599|OTHER||||||=|0.6515|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.6515
74029397|NCT00227877|147613342|SUPERIORITY||Adjusted Relative Risk Ratio|0.63|STANDARD_ERROR_OF_MEAN|0.1|<|0.01|TWO_SIDED|95.0|0.46|0.87|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.|||.87|.46|<.01
73927810|NCT02442778|147384185|SUPERIORITY||LS Mean Difference|1.0||||0.236|TWO_SIDED|95.0|-0.6|2.6||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.6|-0.6|0.236
74029398|NCT00227877|147613343|SUPERIORITY||Adjusted Relative Risk Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|0.54|0.98|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.|||.98|.54|< 0.05
73927811|NCT02442778|147384185|SUPERIORITY||LS Mean Difference|0.3||||0.684|TWO_SIDED|95.0|-1.3|1.9||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.9|-1.3|0.684
73927812|NCT01165138|147384189|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.136||||0.002|TWO_SIDED|95.0|0.051|0.222|||ANCOVA|||||0.222|0.051|0.002
73927813|NCT01165138|147384189|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.087|0.258|||ANCOVA|||||0.258|0.087|<0.001
73927814|NCT01165138|147384189|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.036||||0.405|TWO_SIDED|95.0|-0.048|0.12|||ANCOVA|||||0.120|-0.048|0.405
73927815|NCT01165138|147384190|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.186||||0.003|TWO_SIDED|95.0|0.062|0.31|||ANCOVA|||||0.310|0.062|0.003
73927816|NCT01165138|147384190|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.302|||<|0.001|TWO_SIDED|95.0|0.178|0.426|||ANCOVA|||||0.426|0.178|<0.001
73969758|NCT03461276|147479599|OTHER||||||=|0.7447|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.7447
73969759|NCT03461276|147479599|OTHER||||||=|0.4518|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.4518
74029399|NCT00633139|147613348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4013|TWO_SIDED||||||ANCOVA|||||||0.4013
74029400|NCT00633139|147613349|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275|TWO_SIDED|95.0|||||ANCOVA|||||||0.2750
73927817|NCT01165138|147384190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116||||0.06|TWO_SIDED|95.0|-0.005|0.236|||ANCOVA|||||0.236|-0.005|0.060
73969760|NCT03461276|147479599|OTHER||||||=|0.5416|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.5416
73969761|NCT03461276|147479599|OTHER||||||=|0.3504|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.3504
73969762|NCT03461276|147479599|OTHER||||||=|0.2109|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.2109
73969763|NCT03461276|147479599|OTHER||||||=|0.0049|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0049
74029401|NCT00633139|147613350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1363|TWO_SIDED|95.0|||||ANCOVA|||||||0.1363
74029402|NCT02160977|147613353|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74029403|NCT02160977|147613354|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73969764|NCT03461276|147479599|OTHER||||||=|0.0498|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.0498
73969765|NCT03461276|147479599|OTHER||||||=|0.2181|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2181
73969766|NCT03461276|147479599|OTHER||||||=|0.2087|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.2087
73969767|NCT03461276|147479599|OTHER||||||=|0.8599|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8599
73969768|NCT03461276|147479600|OTHER||||||=|0.9469|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9469
73969769|NCT03461276|147479600|OTHER||||||=|0.9063|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.9063
73969770|NCT03461276|147479600|OTHER||||||=|0.3418|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.3418
73927818|NCT00962104|147384211|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.78|||<|0.001|TWO_SIDED|95.0|-7.66|-3.91||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline CAARS-Inv:SV 18-Item Total ADHD Symptom score .|ANCOVA|||||-3.91|-7.66|<0.001
74087996|NCT01682148|147729881|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.7732|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.7732
74087997|NCT01682148|147729881|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.1758|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.1758
74087998|NCT01682148|147729883|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-0.1324||||0.24|TWO_SIDED|95.0|-0.3531|0.0884||Based on a generalised linear model including factors for treatment, spasticity pattern, country and MAS baseline score.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0884|-0.3531|0.2400
74087999|NCT01682148|147729884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9448|TWO_SIDED|95.0|||||ANOVA|Analysis of variance (ANOVA) included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 4.||||0.9448
74088000|NCT01682148|147729884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5458|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 12.||||0.5458
74088001|NCT01682148|147729885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4006|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country.||||||0.4006
74088002|NCT01682148|147729886|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5747|||||||Mann-Whitney U-test|||||||0.5747
74088003|NCT01682148|147729887|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1802|||||||Mann-Whitney U-test|||||||0.1802
74088004|NCT00350402|147729918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.254|STANDARD_ERROR_OF_MEAN|2.028|<|0.001|TWO_SIDED|95.0|3.147|11.362|||t-test, 2 sided|df = 38; t = 3.576|Treatment effect size: Cohen's D =1.142|Hypothesis: Parkinson patients assigned to high intensity IMST will show greater improvement in facial movement (entropy) relative to those undergoing Sham IMST.||11.362|3.147|< 0.001
74088005|NCT00350402|147729919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.36|STANDARD_ERROR_OF_MEAN|4.955|<|0.459|TWO_SIDED|95.0|-16.41|3.68|||t-test, 2 sided|||Hypothesis: Scores on PDQ-39 would show bigger change for the IMST group than the Sham treatment group. The sample size was not powered for the PDQ-39 (but rather for the primary outcome variable).||3.68|-16.41|<0.459
73927819|NCT00962104|147384212|SUPERIORITY_OR_OTHER||Slope|4.76|||<|0.001|TWO_SIDED|95.0|1.97|7.56||First gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|ANCOVA|Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline AAQoL total score.||||7.56|1.97|<0.001
73927820|NCT00962104|147384213|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.82||||0.289|TWO_SIDED|95.0|-5.2|1.56||Second gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|ANCOVA|Least Squares Mean difference between 2 treatment groups from Type III sum of squares analysis of covariance model:Change=treatment+country+baseline.||||1.56|-5.20|0.289
73927821|NCT00962104|147384214|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.18|||<|0.001|TWO_SIDED|95.0|-8.13|-4.22|||Mixed Models Analysis|||||-4.22|-8.13|<0.001
74088006|NCT00350402|147729920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.426|STANDARD_ERROR_OF_MEAN|4.221|<|0.018|TWO_SIDED|95.0|1.874|18.978|||t-test, 2 sided|t-value = 2.47, with 37 df||Hypothesis: Changes in MIP following treatment would be greater for participants in the IMST versus the Sham treatment group. This is a validity check on for the IMST intervention.||18.978|1.874|<0.018
74088007|NCT00350402|147729921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.129|STANDARD_ERROR_OF_MEAN|2.492|<|0.047|TWO_SIDED|95.0|0.0834|10.17||No adjustment necessary|t-test, 2 sided|38 df, t= 2.058 However, due to inequality of variance (Levine test), the adjusted p-value = \<0.049, and adjusted df = 27.3||Hypothesis: Facial entropy changes would be greater in IMST group than sham treatment group. Sample size was based on preliminary data suggesting total N of 40 would be adequate for detecting change in entropy (of approximately 50%).||10.17|.0834|<0.047
74088008|NCT00063882|147729947|SUPERIORITY||Cox Proportional Hazard|0.82||||0.21|TWO_SIDED|95.0|0.6|1.12||One-sided significance level of 0.025|Greenwood's T||Reference level = Brachytherapy only|Target sample size was 586; 532 patients were needed to test hypothesis of better FFP in the EBRT + Brachytherapy arm over the Brachytherapy Only arm. The trial is designed to detect a 10% improvement in 5-year FFP with 90% power, 1-sided alpha of 0.025. The Z-test statistic for the difference between the 2 5-year FFP rates with the standard errors estimated by Greenwood's method will be used.||1.12|0.60|0.21
74088009|NCT00063882|147729948|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.63|1.54||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.54|0.63|0.95
73862705|NCT04332614|147271284|SUPERIORITY||Odds Ratio (OR)|0.8619131||||0.759|TWO_SIDED|95.0|0.5709078|1.301251||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.301251|0.5709078|0.759
73927822|NCT00962104|147384215|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.18|||<|0.001|TWO_SIDED|95.0|-8.21|-4.14|||Mixed Models Analysis|||||-4.14|-8.21|<0.001
73927823|NCT00962104|147384216|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.59||||0.001|TWO_SIDED|95.0|-5.73|-1.45||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-1.45|-5.73|0.001
73927824|NCT00962104|147384216|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.29|||<|0.001|TWO_SIDED|95.0|-9.28|-3.31||This is the p-value for the Raw MI score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-3.31|-9.28|<0.001
73927825|NCT00962104|147384216|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.76|||<|0.001|TWO_SIDED|95.0|-14.75|-4.78||This is the p-value for the Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-4.78|-14.75|<0.001
73927826|NCT00962104|147384217|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.93||||0.092|TWO_SIDED|95.0|-4.18|0.32||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.32|-4.18|0.092
73927827|NCT00962104|147384217|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.62||||0.272|TWO_SIDED|95.0|-4.52|1.28||This is the p-value for the Raw MI Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||1.28|-4.52|0.272
73927828|NCT00962104|147384217|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.55||||0.153|TWO_SIDED|95.0|-8.43|1.32||This is the p-value for the Raw Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||1.32|-8.43|0.153
73927829|NCT00962104|147384218|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.67|-0.27||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-0.27|-0.67|<0.001
73927830|NCT00962104|147384219|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed using an analysis of variance (ANOVA) with term for treatment and country.|ANOVA|||||||<0.001
73927831|NCT00962104|147384220|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05||||0.869|TWO_SIDED|95.0|-0.71|0.6||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.60|-0.71|0.869
73927832|NCT00962104|147384221|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05||||0.87|TWO_SIDED|95.0|-0.59|0.5||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.50|-0.59|0.870
73927833|NCT02013167|147384222|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.012|TWO_SIDED|95.0|0.55|0.93|||Stratified Log Rank|Stratified by age (\< 35 years; ≥ 35 years), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).|Hazard ratio obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicated a lower average event rate and longer survival time for blinatumomab relative to SOC chemotherapy.|||0.93|0.55|0.012
73927834|NCT02013167|147384223|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|17.9|||<|0.001|TWO_SIDED|95.0|9.6|26.2|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (\< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).||||26.2|9.6|< 0.001
73862706|NCT04332614|147271284|SUPERIORITY||Odds Ratio (OR)|1.0950508||||0.897|TWO_SIDED|95.0|0.7331329|1.635633||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.635633|0.7331329|0.897
73927835|NCT02013167|147384224|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|19.3|||<|0.001|TWO_SIDED|95.0|9.9|28.7|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (\< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).||||28.7|9.9|< 0.001
73927836|NCT02013167|147384225|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.43|0.71|||||The hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer survival for Blinatumomab relative to SOC Chemotherapy.|||0.71|0.43|
73927837|NCT00603746|147384234|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.275|||<|0.001||95.0|0.18|0.37|||ANCOVA|||||0.370|0.180|<0.001
73927838|NCT00603746|147384234|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.272|||<|0.001|TWO_SIDED|95.0|0.178|0.367|||ANCOVA|||||0.367|0.178|<0.001
73927839|NCT00603746|147384234|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.264|||<|0.001|TWO_SIDED|95.0|0.171|0.357|||ANCOVA|||||0.357|0.171|<0.001
73927840|NCT00603746|147384234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|||<|0.001|TWO_SIDED|95.0|0.131|0.32|||ANCOVA|||||0.320|0.131|<0.001
73927841|NCT00603746|147384234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|||<|0.001|TWO_SIDED|95.0|0.105|0.291|||ANCOVA|||||0.291|0.105|<0.001
73927842|NCT01113879|147384262|OTHER||||||<|0.001|TWO_SIDED|85.0|||||Weighted Tau U|||Weighted Tau U effect size mean values in Block 1 of treatment (no aerobic exercise or stretching) were compared to weighted Tau U mean values in Block 2 of treatment (aerobic exercise or stretching adjuvant).||||< 0.001
73927843|NCT00615056|147384275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.273||||0.8268|TWO_SIDED|95.0|0.769|2.108||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||2.108|0.769|0.8268
73927844|NCT00615056|147384275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.041||||0.5498|TWO_SIDED|95.0|0.553|1.041||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||1.041|0.553|0.5498
73927845|NCT00615056|147384276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.355||||0.8828|TWO_SIDED|95.0|0.82|2.238||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||2.238|0.820|0.8828
73969771|NCT03461276|147479600|OTHER||||||=|0.0236|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0236
73927846|NCT00615056|147384276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.689||||0.1159|TWO_SIDED|95.0|0.373|1.273||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||1.273|0.373|0.1159
73927847|NCT00615056|147384277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.4552|TWO_SIDED|95.0|-15.8|17.7|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.||17.7|-15.8|0.4552
73927848|NCT00615056|147384277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.5235|TWO_SIDED|95.0|-19.1|18.0|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.||18.0|-19.1|0.5235
74029404|NCT02160977|147613355|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73927849|NCT00717769|147384282|SUPERIORITY|||||||0.519|||||||ANCOVA|||Change from Baseline to Day 8||||0.519
73927850|NCT00717769|147384282|SUPERIORITY|||||||0.032|||||||ANCOVA|||Change from Baseline to Day 15||||0.032
73927851|NCT00717769|147384282|SUPERIORITY|||||||0.008|||||||ANCOVA|||Change from Baseline to Day 22||||0.008
73927852|NCT00717769|147384282|SUPERIORITY|||||||0.006|||||||ANCOVA|||Change from Baseline to Day 29||||0.006
73927853|NCT00717769|147384284|SUPERIORITY|||||||0.533|||||||ANCOVA|||Change from Baseline to Day 8||||0.533
73927854|NCT00717769|147384284|SUPERIORITY|||||||0.009|||||||ANCOVA|||Change from Baseline to Day 15||||0.009
73927855|NCT00717769|147384284|SUPERIORITY|||||||0.002|||||||ANCOVA|||Change from Baseline to Day 22||||0.002
73927856|NCT00717769|147384284|SUPERIORITY|||||||0.003|||||||ANCOVA|||Change from Baseline to Day 29||||0.003
73927857|NCT01852292|147384378|OTHER|Double Criteria for PFS|Cox Proportional Hazard|0.646|||||TWO_SIDED|95.0|0.44|0.94||||||||0.94|0.44|
73927858|NCT01852292|147384379|OTHER|Double criteria for OS|Cox Proportional Hazard|0.72|||||TWO_SIDED|95.0|0.49|1.04||||||||1.04|0.49|
73927859|NCT02586012|147384404|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73927860|NCT02586012|147384405|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73927861|NCT02586012|147384406|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73927862|NCT04013191|147384408|OTHER||Point Estimate|0.928|||||TWO_SIDED|90.0|0.725|1.19|||ANOVA|||The analysis of variance (ANOVA) model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.19|0.725|
73927863|NCT04013191|147384409|OTHER||Point Estimate|1.22|||||TWO_SIDED|90.0|0.894|1.67|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.67|0.894|
73927864|NCT04013191|147384410|OTHER||Point Estimate|1.22|||||TWO_SIDED|90.0|0.893|1.68|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.68|0.893|
73927865|NCT04013191|147384411|OTHER||Point Estimate|1.02|||||TWO_SIDED|90.0|0.829|1.26|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.26|0.829|
73927866|NCT04013191|147384412|OTHER||Point Estimate|1.18|||||TWO_SIDED|90.0|0.908|1.53|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.53|0.908|
73927867|NCT02904057|147384422|SUPERIORITY||Difference between proportion|92.1|||<|0.0001|TWO_SIDED|95.0|73.4|98.8|||Fisher Exact|||Imputed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with confidence interval (CI) was calculated using an exact approach.||98.8|73.4|<0.0001
73927868|NCT02904057|147384422|SUPERIORITY||Difference between proportion|92.1|||<|0.0001|TWO_SIDED|95.0|73.4|98.8|||Fisher Exact|||Observed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with CI was calculated using an exact approach.||98.8|73.4|<0.0001
73927869|NCT01275066|147384424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|9.35||0.0174||95.0||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.||||||0.0174
73927870|NCT01275066|147384424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|9.29||0.9542||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.||||||0.9542
73927871|NCT01275066|147384425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|1.66||0.4935||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.||||||0.4935
73927872|NCT01275066|147384425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.66||0.7783||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.||||||0.7783
73927873|NCT01275066|147384426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.7|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.||||||<0.0001
73927874|NCT01275066|147384426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|4.19|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.||||||<0.0001
74088010|NCT00063882|147729949|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.97|TWO_SIDED|95.0|0.64|1.58||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.58|0.64|0.97
74088011|NCT00063882|147729950|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.77|TWO_SIDED|95.0|0.36|3.9||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||3.90|0.36|0.77
73927875|NCT00934544|147384435|SUPERIORITY_OR_OTHER||Kaplan-Meir estimate|28.1|STANDARD_DEVIATION|22.123|<|0.0001|TWO_SIDED|95.0|21.3|36.6|||Cochran-Mantel-Haenszel|||||36.6|21.3|<0.0001
73927876|NCT00782210|147384500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.135|<0.0001
73927877|NCT00782210|147384500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.214|0.139|<0.0001
73927878|NCT00782210|147384501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.128|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.128|0.054|<0.0001
73927879|NCT00782210|147384501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.064|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.137|0.064|<0.0001
73969772|NCT03461276|147479600|OTHER||||||=|0.0012|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.0012
73969773|NCT03461276|147479600|OTHER||||||=|0.0004|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.0004
73969774|NCT03461276|147479600|OTHER||||||=|0.0008|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0008
73969775|NCT03461276|147479600|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
74088012|NCT00063882|147729951|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.33|3.13||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||3.13|0.33|0.99
73969776|NCT03461276|147479600|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
73969777|NCT03461276|147479600|OTHER||||||=|0.1255|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1255
73969778|NCT03461276|147479600|OTHER||||||=|0.4232|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.4232
73969779|NCT03461276|147479601|OTHER||||||=|0.9211|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9211
73969780|NCT03461276|147479601|OTHER||||||=|0.2817|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.2817
73969781|NCT03461276|147479601|OTHER||||||=|0.2984|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.2984
73969782|NCT03461276|147479601|OTHER||||||=|0.8402|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.8402
73969783|NCT03461276|147479601|OTHER||||||=|0.4428|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.4428
73969784|NCT03461276|147479601|OTHER||||||=|0.4156|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.4156
73969785|NCT03461276|147479601|OTHER||||||=|0.8706|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.8706
73927880|NCT00782210|147384502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.113|0.233|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.233|0.113|<0.0001
73927881|NCT00782210|147384502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.108|0.229|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.229|0.108|<0.0001
73927882|NCT00782210|147384503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.201|0.128|<0.0001
73927883|NCT00782210|147384503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.139|<0.0001
73927884|NCT00782210|147384504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.144|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.144|<0.0001
73927885|NCT00782210|147384504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.156|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.156|<0.0001
73969786|NCT03461276|147479601|OTHER||||||=|0.8691|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.8691
73969787|NCT03461276|147479601|OTHER||||||=|0.2188|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2188
73969788|NCT03461276|147479601|OTHER||||||=|0.1448|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1448
73969789|NCT03461276|147479601|OTHER||||||=|0.5004|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5004
73969790|NCT03461276|147479602|OTHER||||||=|0.1058|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.1058
73969791|NCT03461276|147479602|OTHER||||||=|0.0922|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0922
73969792|NCT03461276|147479603|OTHER||||||=|0.9313|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.9313
73969793|NCT03461276|147479603|OTHER||||||=|0.2243|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2243
73969794|NCT03461276|147479603|OTHER||||||=|0.0952|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0952
73969795|NCT03461276|147479604|OTHER||||||=|0.3599|||||||Mixed Models Analysis|||MMRM - Week 24A - left||||= 0.3599
73969796|NCT03461276|147479604|OTHER||||||=|0.8913|||||||Mixed Models Analysis|||MMRM - Week 50A - left||||= 0.8913
73969797|NCT03461276|147479604|OTHER||||||=|0.4736|||||||Mixed Models Analysis|||MMRM - Week 104A - left||||= 0.4736
74088013|NCT00063882|147729952|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.81|TWO_SIDED|95.0|0.46|2.76||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||2.76|0.46|0.81
74088014|NCT00063882|147729953|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.22|TWO_SIDED|95.0|0.51|1.17||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.17|0.51|0.22
73927886|NCT00782210|147384505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.133|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.207|0.133|<0.0001
73927887|NCT00782210|147384505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.13|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.204|0.130|<0.0001
73927888|NCT00782210|147384506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.136|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.212|0.136|<0.0001
73927889|NCT00782210|147384506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.123|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.199|0.123|<0.0001
73927890|NCT00782210|147384507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.134|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.211|0.134|<0.0001
73927891|NCT00782210|147384507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.131|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.208|0.131|<0.0001
73927892|NCT00782210|147384508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|0.059|<0.0001
73927893|NCT00782210|147384508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.075|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.147|0.075|<0.0001
73927894|NCT00782210|147384509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|0.059|<0.0001
73927895|NCT00782210|147384509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.127|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.127|0.054|<0.0001
73927896|NCT00782210|147384510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.061|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.135|0.061|<0.0001
73927897|NCT00782210|147384510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.064|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.138|0.064|<0.0001
73927898|NCT00782210|147384511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.049|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|0.049|<0.0001
73927899|NCT00782210|147384511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.051|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.126|0.051|<0.0001
73927900|NCT00782210|147384512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.130|0.054|<0.0001
73927901|NCT00782210|147384512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.048|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.123|0.048|<0.0001
73927902|NCT00782210|147384513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.069|0.145|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.145|0.069|<0.0001
73969798|NCT03461276|147479604|OTHER||||||=|0.9095|||||||Mixed Models Analysis|||MMRM - Week 24A - right||||= 0.9095
73969799|NCT03461276|147479604|OTHER||||||=|0.8744|||||||Mixed Models Analysis|||MMRM - Week 50A - right||||= 0.8744
73969800|NCT03461276|147479604|OTHER||||||=|0.9307|||||||Mixed Models Analysis|||MMRM - Week 104A - right||||= 0.9307
73969801|NCT03461276|147479605|OTHER||||||=|0.3982|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.3982
73969802|NCT03461276|147479605|OTHER||||||=|0.7035|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7035
73969803|NCT03461276|147479605|OTHER||||||=|0.6334|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6334
73969804|NCT03461276|147479606|OTHER||||||=|0.2193|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2193
73969805|NCT03461276|147479606|OTHER||||||=|0.5543|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5543
73969806|NCT03461276|147479607|OTHER||||||=|0.7324|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7324
73969807|NCT03461276|147479607|OTHER||||||=|0.1719|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.1719
74029405|NCT00410280|147613360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.44||||0.0947|TWO_SIDED|95.0|-14.04|1.15|||ANOVA|||Repeated measures analysis of variance (ANOVA) model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95 % confidence interval (CI) and p-value were derived from the model.||1.15|-14.04|0.0947
74029406|NCT00410280|147613361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.24||||0.2673|TWO_SIDED|95.0|-11.84|3.35|||ANOVA|||Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||3.35|-11.84|0.2673
74029407|NCT00410280|147613362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8||||0.0391|TWO_SIDED|95.0|-46.35|-1.24|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-1.24|-46.35|0.0391
73927903|NCT00782210|147384513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.068|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|0.068|<0.0001
73927904|NCT00782210|147384514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.055|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.130|0.055|<0.0001
73927905|NCT00782210|147384514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.053|0.129|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.129|0.053|<0.0001
73927906|NCT00782210|147384515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.115|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.194|0.115|<0.0001
73927907|NCT00782210|147384515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.131|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.211|0.131|<0.0001
73927908|NCT00782210|147384516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.137|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.137|<0.0001
73927909|NCT00782210|147384516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.15|0.23|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.230|0.150|<0.0001
73927910|NCT00782210|147384517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.212|0.132|<0.0001
73927911|NCT00782210|147384517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.132|<0.0001
73862707|NCT04332614|147271284|SUPERIORITY||Odds Ratio (OR)|1.2704886||||0.498|TWO_SIDED|95.0|0.8377249|1.926816||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.926816|0.8377249|0.498
73927912|NCT00782210|147384518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.123|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.204|0.123|<0.0001
73927913|NCT00782210|147384518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.124|<0.0001
73927914|NCT00782210|147384519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.134|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.216|0.134|<0.0001
73927915|NCT00782210|147384519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.192|0.110|<0.0001
73927916|NCT00782210|147384520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.128|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.211|0.128|<0.0001
73927917|NCT00782210|147384520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.121|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.205|0.121|<0.0001
74088015|NCT00063882|147729954|SUPERIORITY||Odds Ratio (OR)|1.13||||0.53|TWO_SIDED|95.0|0.76|1.67||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ GU/GI||1.67|0.76|0.53
73927918|NCT00782210|147384521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.216|0.359|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.359|0.216|<0.0001
73927919|NCT00782210|147384521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.258|0.401|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.401|0.258|<0.0001
73927920|NCT00782210|147384522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.224|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.368|0.224|<0.0001
73927921|NCT00782210|147384522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.327|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.255|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.399|0.255|<0.0001
73927922|NCT00782210|147384523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.181|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.327|0.181|<0.0001
73927923|NCT00782210|147384523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.22|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.366|0.220|<0.0001
73927924|NCT00782210|147384524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.201|0.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.348|0.201|<0.0001
73927925|NCT00782210|147384524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.219|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.366|0.219|<0.0001
73927926|NCT00782210|147384525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.309|0.161|<0.0001
73927927|NCT00782210|147384525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.18|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.329|0.180|<0.0001
73927928|NCT00782210|147384526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.169|0.319|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.319|0.169|<0.0001
73927929|NCT00782210|147384526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.271|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.196|0.346|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.346|0.196|<0.0001
73927930|NCT00782210|147384527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.076|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.218|0.076|<0.0001
73927931|NCT00782210|147384527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.113|0.255|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.255|0.113|<0.0001
73927932|NCT00782210|147384528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.037||0.0003||95.0|0.059|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.059|0.0003
73927933|NCT00782210|147384528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.036||0.0001||95.0|0.069|0.213|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.213|0.069|0.0001
73969808|NCT03461276|147479608|OTHER||||||=|0.7977|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7977
73969809|NCT03461276|147479608|OTHER||||||=|0.8828|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8828
73969810|NCT03461276|147479609|OTHER||||||=|0.7954|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7954
73969811|NCT03461276|147479609|OTHER||||||=|0.5895|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5895
73969812|NCT03461276|147479610|OTHER||||||=|0.743|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.743
73969813|NCT03461276|147479610|OTHER||||||=|0.832|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.832
73969814|NCT03461276|147479611|OTHER||||||=|0.2283|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2283
73969815|NCT03461276|147479611|OTHER||||||=|0.886|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.886
73969816|NCT03461276|147479612|OTHER||||||=|0.909|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.909
73927934|NCT00782210|147384529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.037||0.0019||95.0|0.043|0.187|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.187|0.043|0.0019
73969817|NCT03461276|147479612|OTHER||||||=|0.8498|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8498
73969818|NCT03461276|147479613|OTHER||||||=|0.8711|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.8711
73969819|NCT03461276|147479613|OTHER||||||=|0.1098|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.1098
73969820|NCT03461276|147479613|OTHER||||||=|0.6179|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.6179
73969821|NCT03461276|147479613|OTHER||||||=|0.3715|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3715
73969822|NCT03461276|147479614|OTHER||||||=|0.8949|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.8949
73969823|NCT03461276|147479614|OTHER||||||=|0.8712|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.8712
73969824|NCT03461276|147479614|OTHER||||||=|0.8748|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.8748
73969825|NCT03461276|147479614|OTHER||||||=|0.6402|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6402
73969826|NCT03461276|147479615|OTHER||||||=|0.552|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.552
73969827|NCT03461276|147479615|OTHER||||||=|0.9371|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.9371
73969828|NCT03461276|147479615|OTHER||||||=|0.2354|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.2354
73969829|NCT03461276|147479615|OTHER||||||=|0.4608|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.4608
73969830|NCT03461276|147479616|OTHER||||||=|0.3246|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.3246
73969831|NCT03461276|147479616|OTHER||||||=|0.8047|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.8047
73969832|NCT03461276|147479616|OTHER||||||=|0.916|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.916
73969833|NCT03461276|147479616|OTHER||||||=|0.9582|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.9582
73969834|NCT03461276|147479617|OTHER||||||=|0.777|||||||Mixed Models Analysis|||MMRM - Week 24A - Trail A||||= 0.777
73969835|NCT03461276|147479617|OTHER||||||=|0.1727|||||||Mixed Models Analysis|||MMRM - Week 50A - Trail A||||= 0.1727
73969836|NCT03461276|147479617|OTHER||||||=|0.0218|||||||Mixed Models Analysis|||MMRM - Week 77A - Trail A||||= 0.0218
73969837|NCT03461276|147479617|OTHER||||||=|0.2789|||||||Mixed Models Analysis|||MMRM - Week 104A - Trail A||||= 0.2789
73969838|NCT03461276|147479617|OTHER||||||=|0.2261|||||||Mixed Models Analysis|||MMRM - Week 24A - Trail B||||= 0.2261
73969839|NCT03461276|147479617|OTHER||||||=|0.9743|||||||Mixed Models Analysis|||MMRM - Week 50A - Trail B||||= 0.9743
73969840|NCT03461276|147479617|OTHER||||||=|0.2556|||||||Mixed Models Analysis|||MMRM - Week 77A - Trail B||||= 0.2556
73969841|NCT03461276|147479617|OTHER||||||=|0.1008|||||||Mixed Models Analysis|||MMRM - Week 104A - Trail B||||= 0.1008
73969842|NCT03461276|147479618|OTHER||||||=|0.6189|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.6189
73969843|NCT03461276|147479618|OTHER||||||=|0.6937|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.6937
73969844|NCT03461276|147479618|OTHER||||||=|0.6981|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6981
73969845|NCT03461276|147479620|OTHER||||||=|0.2863|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2863
73969846|NCT03461276|147479620|OTHER||||||=|0.3703|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3703
73969847|NCT03461276|147479621|OTHER||||||=|0.9663|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.9663
73969848|NCT03461276|147479621|OTHER||||||=|0.3843|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3843
73969849|NCT03461276|147479622|SUPERIORITY||||||<|0.0001||||||A 1-sided t-test with a significance level of 0.025 was employed.|t-test, 1 sided|||"The trial was considered successfully confirmatory regarding efficacy (immunogenicity) of ABvac40 if the average MΔ of anti-Aβ40 antibody signal (OD in ELISA) in the ABvac40 group was significantly greater than the average MΔ of anti-Aβ40 antibody signal in the Placebo group. i.e.~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) ≤ average MΔ anti-Aβ40 (placebo).~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) \> average MΔ anti-Aβ40 (placebo)"||||< 0.0001
73969850|NCT03461276|147479622|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
73969851|NCT03461276|147479622|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|3.02|3.4|||ANCOVA|||||3.4|3.02|< 0.0001
73969852|NCT03848065|147479633|OTHER||Difference in Percentages|17.8||||0.004|TWO_SIDED|95.0|9.0|31.4|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Erythema (Redness)||31.4|9.0|0.004
73969853|NCT03848065|147479633|OTHER||Difference in Percentages|4.7||||0.15|TWO_SIDED|95.0|-3.7|15.5|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Erythema (Redness)||15.5|-3.7|0.150
73969854|NCT03848065|147479633|OTHER||Difference in Percentages|-13.1||||0.054|TWO_SIDED|95.0|-27.6|0.2|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Erythema (Redness)||0.2|-27.6|0.054
73969855|NCT03848065|147479633|OTHER||Difference in Percentages|13.1||||0.091|TWO_SIDED|95.0|-2.3|28.8|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Induration (Hard Lump)||28.8|-2.3|0.091
73969856|NCT03848065|147479633|OTHER||Difference in Percentages|-9.1||||0.044|TWO_SIDED|95.0|-21.2|-0.4|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Induration (Hard Lump)||-0.4|-21.2|0.044
73969857|NCT03848065|147479633|OTHER||Difference in Percentages|-22.2||||0.001|TWO_SIDED|95.0|-36.4|-12.5|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Induration (Hard Lump)||-12.5|-36.4|0.001
73969858|NCT03848065|147479633|OTHER||Difference in Percentages|9.7||||0.333|TWO_SIDED|95.0|-10.0|28.9|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Pain||28.9|-10.0|0.333
74029408|NCT00410280|147613362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.17||||0.1326|TWO_SIDED|95.0|-39.72|5.39|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||5.39|-39.72|0.1326
74029409|NCT00410280|147613363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.76||||0.0423|TWO_SIDED|95.0|-19.16|-0.35|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-0.35|-19.16|0.0423
73927935|NCT00782210|147384529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.088|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.233|0.088|<0.0001
73927936|NCT00782210|147384530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.037||0.0005||95.0|0.057|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.057|0.0005
73927937|NCT00782210|147384530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.089|0.235|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.235|0.089|<0.0001
73927938|NCT00782210|147384531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.037||0.0261||95.0|0.01|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.156|0.010|0.0261
73969859|NCT03848065|147479633|OTHER||Difference in Percentages|-3.2||||0.76|TWO_SIDED|95.0|-23.4|17.2|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Pain||17.2|-23.4|0.760
73969860|NCT03848065|147479633|OTHER||Difference in Percentages|-13.0||||0.205|TWO_SIDED|95.0|-32.2|7.1|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Pain||7.1|-32.2|0.205
73969861|NCT03848065|147479633|OTHER||Difference in Percentages|13.0||||0.128|TWO_SIDED|95.0|-3.9|29.7|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Swelling||29.7|-3.9|0.128
73969862|NCT03848065|147479633|OTHER||Difference in Percentages|-2.0||||0.779|TWO_SIDED|95.0|-17.0|13.0|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Swelling||13.0|-17.0|0.779
73969863|NCT03848065|147479633|OTHER||Difference in Parentages|-15.0||||0.076|TWO_SIDED|95.0|-31.5|1.7|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Swelling||1.7|-31.5|0.076
73969864|NCT03848065|147479634|OTHER||Difference in Percentages|-10.6||||0.282|TWO_SIDED|95.0|-29.1|8.7|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Decreased Appetite (Appetite Loss)||8.7|-29.1|0.282
73969865|NCT03848065|147479634|OTHER||Difference in Percentages|-9.9||||0.317|TWO_SIDED|95.0|-28.7|9.5|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Decreased Appetite (Appetite Loss)||9.5|-28.7|0.317
73927939|NCT00782210|147384531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.037||0.001||95.0|0.05|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.050|0.0010
73927940|NCT00782210|147384532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.038||0.0154||95.0|0.018|0.165|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.165|0.018|0.0154
73969866|NCT03848065|147479634|OTHER||Difference in Percentages|0.7||||0.948|TWO_SIDED|95.0|-19.2|20.4|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Decreased Appetite (Appetite Loss)||20.4|-19.2|0.948
73969867|NCT03848065|147479634|OTHER||Difference in Percentages|10.5||||0.303|TWO_SIDED|95.0|-9.4|29.6|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Somnolence (Drowsiness)||29.6|-9.4|0.303
73969868|NCT03848065|147479634|OTHER||Difference in Percentages|-4.0||||0.681|TWO_SIDED|95.0|-22.6|15.0|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Somnolence (Drowsiness)||15.0|-22.6|0.681
73969869|NCT03848065|147479634|OTHER||Difference in Percentages|-14.4||||0.153|TWO_SIDED|95.0|-33.2|5.4|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Somnolence (Drowsiness)||5.4|-33.2|0.153
73969870|NCT03848065|147479634|OTHER||Difference in Percentages|10.7||||0.237|TWO_SIDED|95.0|-7.2|28.2|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Irritability||28.2|-7.2|0.237
74088016|NCT00063882|147729954|SUPERIORITY||Odds Ratio (OR)|1.06||||0.73|TWO_SIDED|95.0|0.73|1.53||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ Overall||1.53|0.73|0.73
74088017|NCT00063882|147729954|SUPERIORITY||Odds Ratio (OR)|1.09||||0.81|TWO_SIDED|95.0|0.54|2.19||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ GU/GI||2.19|0.54|0.81
74088018|NCT00063882|147729954|SUPERIORITY||Odds Ratio (OR)|0.93||||0.82|TWO_SIDED|95.0|0.51|1.69||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ Overall||1.69|0.51|0.82
74088019|NCT00063882|147729955|SUPERIORITY||Hazard Ratio (HR)|2.37||||0.01|TWO_SIDED|95.0|1.2|4.68||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ GU/GI||4.68|1.20|0.01
73927941|NCT00782210|147384532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.038||0.0011||95.0|0.049|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.049|0.0011
73927942|NCT00782210|147384533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.038||0.0006||95.0|0.057|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.205|0.057|0.0006
73927943|NCT00782210|147384533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.08|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.080|<0.0001
73927944|NCT00782210|147384534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.038||0.0134||95.0|0.019|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.168|0.019|0.0134
73927945|NCT00782210|147384534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.038||0.0025||95.0|0.04|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.190|0.040|0.0025
73927946|NCT00782210|147384535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.187|0.339|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.339|0.187|<0.0001
73927947|NCT00782210|147384535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.225|0.376|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.376|0.225|<0.0001
73927948|NCT00782210|147384536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.188|0.341|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.341|0.188|<0.0001
73927949|NCT00782210|147384536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.216|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.368|0.216|<0.0001
74029410|NCT00410280|147613363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.06||||0.3902|TWO_SIDED|95.0|-13.46|5.35|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||5.35|-13.46|0.3902
74029411|NCT00410280|147613364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.05||||0.0302|TWO_SIDED|95.0|-36.21|-1.9|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-1.90|-36.21|0.0302
73927950|NCT00782210|147384537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.174|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.328|0.174|<0.0001
73927951|NCT00782210|147384537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.203|0.358|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.358|0.203|<0.0001
73927952|NCT00782210|147384538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.174|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.329|0.174|<0.0001
73927953|NCT00782210|147384538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.183|0.338|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.338|0.183|<0.0001
73927954|NCT00782210|147384539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.153|<0.0001
73927955|NCT00782210|147384539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.154|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.311|0.154|<0.0001
73927956|NCT00782210|147384540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.168|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.327|0.168|<0.0001
73927957|NCT00782210|147384540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.181|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.340|0.181|<0.0001
74088020|NCT00063882|147729955|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.029|TWO_SIDED|95.0|1.06|3.1||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ Overall||3.10|1.06|0.029
73927958|NCT00782210|147384541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.181|0.422|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.422|0.181|<0.0001
73927959|NCT00782210|147384541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.128|0.37|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.370|0.128|<0.0001
73927960|NCT00782210|147384542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.357|STANDARD_ERROR_OF_MEAN|4.253||0.0018|TWO_SIDED|95.0|5.005|21.709|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||21.709|5.005|0.0018
73927961|NCT00782210|147384542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.457|STANDARD_ERROR_OF_MEAN|4.248||0.0003|TWO_SIDED|95.0|7.114|23.8|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||23.800|7.114|0.0003
73927962|NCT00782210|147384543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.186|STANDARD_ERROR_OF_MEAN|4.245|<|0.0001|TWO_SIDED|95.0|8.849|25.523|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||25.523|8.849|<0.0001
73927963|NCT00782210|147384543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.56|STANDARD_ERROR_OF_MEAN|4.226||0.0006|TWO_SIDED|95.0|6.259|22.86|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||22.860|6.259|0.0006
73927964|NCT00782210|147384544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.182||0.0045|TWO_SIDED|95.0|-0.878|-0.162|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.162|-0.878|0.0045
73927965|NCT00782210|147384544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.648|STANDARD_ERROR_OF_MEAN|0.182||0.0004|TWO_SIDED|95.0|-1.005|-0.291|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.291|-1.005|0.0004
73927966|NCT00782210|147384545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.582|STANDARD_ERROR_OF_MEAN|0.202||0.0041|TWO_SIDED|95.0|-0.979|-0.185|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.185|-0.979|0.0041
73927967|NCT00782210|147384545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.792|STANDARD_ERROR_OF_MEAN|0.202||0.0001|TWO_SIDED|95.0|-1.189|-0.394|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.394|-1.189|0.0001
73927968|NCT00782210|147384546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.104|STANDARD_ERROR_OF_MEAN|0.354||0.0019|TWO_SIDED|95.0|-1.799|-0.409|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.409|-1.799|0.0019
73927969|NCT00782210|147384546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.435|STANDARD_ERROR_OF_MEAN|0.354|<|0.0001|TWO_SIDED|95.0|-2.13|-0.74|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.740|-2.130|<0.0001
73927970|NCT00782210|147384547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.3|-0.7|<0.0001
73927971|NCT00782210|147384547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.3|-0.7|<0.0001
73927972|NCT00782210|147384548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
73927973|NCT00782210|147384548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.2|-0.6|<0.0001
73927974|NCT00782210|147384549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
73927975|NCT00782210|147384549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
73927976|NCT00782210|147384550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0109||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0109
73969871|NCT03848065|147479634|OTHER||Difference in Percentages|7.4||||0.406|TWO_SIDED|95.0|-10.3|25.0|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Irritability||25.0|-10.3|0.406
73969872|NCT03848065|147479634|OTHER||Difference in Percentages|-3.3||||0.729|TWO_SIDED|95.0|-21.8|15.5|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Irritability||15.5|-21.8|0.729
73969873|NCT03848065|147479634|OTHER||Difference in Percentages|4.6||||0.385|TWO_SIDED|95.0|-7.1|17.5|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Urticaria (Hives/Welts)||17.5|-7.1|0.385
73969874|NCT03848065|147479634|OTHER||Difference in Percentages|2.1||||0.719|TWO_SIDED|95.0|-11.0|15.4|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Urticaria (Hives/Welts)||15.4|-11.0|0.719
73969875|NCT03848065|147479634|OTHER||Difference in Percentages|-2.5||||0.61|TWO_SIDED|95.0|-14.9|8.9|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Urticaria (Hives/Welts)||8.9|-14.9|0.610
73969876|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||8.5|-8.1|
73969877|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||8.5|-7.9|
73969878|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||7.9|-8.1|
73927977|NCT00782210|147384550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0031||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0031
73927978|NCT00782210|147384551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.728|STANDARD_ERROR_OF_MEAN|0.124||0.0658|TWO_SIDED|95.0|0.522|1.016|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.016|0.522|0.0658
73927979|NCT00782210|147384551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.799|STANDARD_ERROR_OF_MEAN|0.133||0.1701|TWO_SIDED|95.0|0.576|1.107|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.107|0.576|0.1701
73927980|NCT00782210|147384552|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.656|STANDARD_ERROR_OF_MEAN|0.247||0.2754|TWO_SIDED|95.0|0.313|1.374|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.374|0.313|0.2754
73927981|NCT00782210|147384552|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|STANDARD_ERROR_OF_MEAN|0.342||0.9792|TWO_SIDED|95.0|0.521|1.961|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.961|0.521|0.9792
73927982|NCT00782210|147384553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739|STANDARD_ERROR_OF_MEAN|0.142||0.1194|TWO_SIDED|95.0|0.506|1.078|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.078|0.506|0.1194
74029412|NCT00410280|147613364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.19||||0.1289|TWO_SIDED|95.0|-30.34|3.97|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||3.97|-30.34|0.1289
74029413|NCT00410280|147613365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.8469|TWO_SIDED|95.0|-0.79|0.96|||Mixed Models Analysis|||Screening: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.96|-0.79|0.8469
73927983|NCT00782210|147384553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.811|STANDARD_ERROR_OF_MEAN|0.153||0.257|TWO_SIDED|95.0|0.561|1.174|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.174|0.561|0.2570
73927984|NCT00782210|147384554|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7815|STANDARD_ERROR_OF_MEAN|0.138||0.1631|TWO_SIDED|95.0|0.5524|1.1054|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.1054|0.5524|0.1631
73927985|NCT00782210|147384554|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8456|STANDARD_ERROR_OF_MEAN|0.1467||0.3342|TWO_SIDED|95.0|0.6015|1.1889|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.1889|0.6015|0.3342
73927986|NCT00782210|147384555|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.655|STANDARD_ERROR_OF_MEAN|0.2664||0.2985|TWO_SIDED|95.0|0.2947|1.4556|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.4556|0.2947|0.2985
73927987|NCT00782210|147384555|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1211|STANDARD_ERROR_OF_MEAN|0.4103||0.755|TWO_SIDED|95.0|0.5464|2.3003|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.3003|0.5464|0.7550
73927988|NCT00782210|147384556|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8081|STANDARD_ERROR_OF_MEAN|0.163||0.2911|TWO_SIDED|95.0|0.5438|1.2008|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.2008|0.5438|0.2911
73927989|NCT00782210|147384556|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8485|STANDARD_ERROR_OF_MEAN|0.1686||0.4086|TWO_SIDED|95.0|0.5743|1.2535|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.2535|0.5743|0.4086
73927990|NCT00265616|147384559|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
73927991|NCT00265616|147384560|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Fisher Exact|||||||0.67
73927992|NCT00265616|147384561|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
73927993|NCT00265616|147384563|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Fisher Exact|||||||0.4
73927994|NCT00265616|147384564|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
73927995|NCT00654381|147384565|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.04|-0.7|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12||-0.7|-1.04|<0.0001
73927996|NCT00654381|147384565|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.05|-0.71|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12||-0.71|-1.05|<0.0001
73927997|NCT00654381|147384566|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0003|TWO_SIDED|95.0|-0.49|-0.15|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||||-0.15|-0.49|0.0003
73927998|NCT00654381|147384566|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.21|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26||-0.21|-0.56|<0.0001
73927999|NCT00654381|147384570|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-25.4|-14.0|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12||-14.0|-25.4|<0.0001
73928000|NCT00654381|147384570|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-26.2|-14.7|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12||-14.7|-26.2|<0.0001
73928001|NCT00654381|147384571|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|3.1||0.0239|TWO_SIDED|95.0|-13.0|-0.9|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs Voglibose at week 26||-0.9|-13.0|0.0239
73928002|NCT00654381|147384571|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|3.1||0.0015|TWO_SIDED|95.0|-15.8|-3.8|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26||-3.8|-15.8|0.0015
73928003|NCT02623803|147384590|SUPERIORITY|||||||0.1459|||||||Wilcoxon (Mann-Whitney)|||||||0.1459
73928004|NCT02623803|147384591|SUPERIORITY|||||||0.205|||||||Wilcoxon (Mann-Whitney)|||||||0.2050
73928005|NCT02623803|147384592|SUPERIORITY|||||||0.3989|||||||Wilcoxon (Mann-Whitney)|||||||0.3989
73928006|NCT02623803|147384593|SUPERIORITY|||||||0.5285|||||||Wilcoxon (Mann-Whitney)|||||||0.5285
73928007|NCT02623803|147384594|SUPERIORITY|||||||0.0697|||||||Wilcoxon (Mann-Whitney)|||||||0.0697
73928008|NCT02623803|147384595|SUPERIORITY|||||||0.1029|||||||Wilcoxon (Mann-Whitney)|||||||0.1029
73928009|NCT02623803|147384596|SUPERIORITY|||||||0.3136|||||||Wilcoxon (Mann-Whitney)|||||||0.3136
73928010|NCT02623803|147384597|SUPERIORITY|||||||0.2196|||||||Wilcoxon (Mann-Whitney)|||||||0.2196
73928011|NCT02623803|147384598|SUPERIORITY|||||||0.3057|||||||Wilcoxon (Mann-Whitney)|||||||0.3057
73928012|NCT02623803|147384599|SUPERIORITY|||||||0.0404|||||||Wilcoxon (Mann-Whitney)|||||||0.0404
73928013|NCT02623803|147384600|SUPERIORITY|||||||0.5314|||||||Wilcoxon (Mann-Whitney)|||||||0.5314
73928014|NCT02623803|147384601|SUPERIORITY|||||||0.3166|||||||Wilcoxon (Mann-Whitney)|||||||0.3166
73928015|NCT02623803|147384602|SUPERIORITY|||||||0.2363|||||||Wilcoxon (Mann-Whitney)|||||||0.2363
73928016|NCT02623803|147384603|SUPERIORITY|||||||0.9171|||||||Wilcoxon (Mann-Whitney)|||||||0.9171
73928017|NCT02623803|147384604|SUPERIORITY|||||||0.4194|||||||Wilcoxon (Mann-Whitney)|||||||0.4194
73928018|NCT02623803|147384605|SUPERIORITY|||||||0.7073|||||||Wilcoxon (Mann-Whitney)|||||||0.7073
73928019|NCT02623803|147384606|SUPERIORITY|||||||0.5107|||||||Wilcoxon (Mann-Whitney)|||||||0.5107
73928020|NCT02623803|147384607|SUPERIORITY|||||||0.8339|||||||Wilcoxon (Mann-Whitney)|||||||0.8339
73928021|NCT02623803|147384608|SUPERIORITY|||||||0.8927|||||||Wilcoxon (Mann-Whitney)|||||||0.8927
73928022|NCT01675882|147384621|SUPERIORITY||Relative risk|1.81||||0.0292|TWO_SIDED|95.0|1.05|3.11|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05. Thus, no conclusion can be made on the comparison of viaskin peanut 50 µg vs placebo.||3.11|1.05|0.0292
73928023|NCT01675882|147384621|SUPERIORITY||Relative risk|1.64||||0.1074|TWO_SIDED|95.0|0.95|2.85|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05.||2.85|0.95|0.1074
73928024|NCT01675882|147384621|SUPERIORITY||Relative risk|2.0||||0.0108|TWO_SIDED|95.0|1.18|3.38|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05.||3.38|1.18|0.0108
73928025|NCT01675882|147384622|SUPERIORITY||Relative risk|2.95||||0.0035|TWO_SIDED|95.0|1.34|6.49|||Fisher Exact|||||6.49|1.34|0.0035
73928026|NCT01675882|147384622|SUPERIORITY||Relative risk|2.38||||0.0453|TWO_SIDED|95.0|1.04|5.47|||Fisher Exact|||||5.47|1.04|0.0453
73928027|NCT01675882|147384622|SUPERIORITY||Relative risk|2.77||||0.0076|TWO_SIDED|95.0|1.25|6.14|||Fisher Exact|||||6.14|1.25|0.0076
73928028|NCT01675882|147384623|SUPERIORITY||Relative risk|1.5||||0.7112|TWO_SIDED|95.0|0.51|4.43|||Fisher Exact|||||4.43|0.51|0.7112
73928029|NCT01675882|147384623|SUPERIORITY||Relative risk|0.47||||0.4048|TWO_SIDED|95.0|0.1|2.28|||Fisher Exact|||||2.28|0.10|0.4048
73969879|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114- SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||8.5|-8.1|
73969880|NCT03848065|147479636|OTHER||Difference in Percentages|-2.2|||||TWO_SIDED|95.0|-11.7|6.3|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||6.3|-11.7|
73928030|NCT01675882|147384623|SUPERIORITY||Relative risk|1.75||||0.4705|TWO_SIDED|95.0|0.62|4.95|||Fisher Exact|||||4.95|0.62|0.4705
73928031|NCT01675882|147384624|SUPERIORITY||Relative risk|0.5||||0.5921|TWO_SIDED|95.0|0.13|1.9|||Fisher Exact|||||1.90|0.13|0.5921
73928032|NCT01675882|147384624|SUPERIORITY||Relative risk|1.43||||0.326|TWO_SIDED|95.0|0.71|2.88|||Fisher Exact|||||2.88|0.71|0.3260
73928033|NCT01675882|147384624|SUPERIORITY||Relative risk|1.05||||1|TWO_SIDED|95.0|0.46|2.38|||Fisher Exact|||||2.38|0.46|1.0000
73928034|NCT01675882|147384625|SUPERIORITY||Difference in LS mean|70.2||||0.0607|TWO_SIDED|95.0|-2.41|193.69||P-value was based on type III sum of squares from analysis of covariance (ANCOVA) model on log transformed values for peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The least squares (LS) mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||193.69|-2.41|0.0607
73969881|NCT03848065|147479636|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-6.0|11.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||11.6|-6.0|
74029414|NCT00410280|147613365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9995|TWO_SIDED|95.0|-0.86|0.86|||Mixed Models Analysis|||Day 14: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.86|-0.86|0.9995
73928035|NCT01675882|147384625|SUPERIORITY||Difference in LS mean|97.5||||0.015|TWO_SIDED|95.0|14.45|237.82||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||237.82|14.45|0.0150
73928036|NCT01675882|147384625|SUPERIORITY||Difference in LS mean|242.2|||<|0.0001|TWO_SIDED|95.0|100.03|482.65||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||482.65|100.03|<0.0001
73928037|NCT01675882|147384626|SUPERIORITY||Difference in LS mean|73.9||||0.0372|TWO_SIDED|95.0|2.96|225.85||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||225.85|2.96|0.0372
73928038|NCT01675882|147384626|SUPERIORITY||Difference in LS mean|96.7||||0.0143|TWO_SIDED|95.0|12.92|278.11||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||278.11|12.92|0.0143
73928039|NCT01675882|147384626|SUPERIORITY||Difference in LS mean|260.3|||<|0.0001|TWO_SIDED|95.0|89.83|625.95||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||625.95|89.83|<0.0001
73928040|NCT01675882|147384627|SUPERIORITY||Difference in LS mean|26.1||||0.6596|TWO_SIDED|95.0|-59.58|236.0||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||236.00|-59.58|0.6596
73969882|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||8.5|-8.1|
73969883|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||8.5|-7.9|
73969884|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||7.9|-8.1|
73969885|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||8.5|-8.1|
73928041|NCT01675882|147384627|SUPERIORITY||Difference in LS mean|8.9||||0.8702|TWO_SIDED|95.0|-65.9|189.96||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||189.96|-65.90|0.8702
73928042|NCT01675882|147384627|SUPERIORITY||Difference in LS mean|158.9||||0.063|TWO_SIDED|95.0|-5.5|562.31||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||562.31|-5.50|0.0630
73928043|NCT01675882|147384628|SUPERIORITY||Difference in LS mean|-80.2||||0.6776|TWO_SIDED|95.0|-237.22|782.24||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||782.24|-237.22|0.6776
73928044|NCT01675882|147384628|SUPERIORITY||Difference in LS mean|158.8||||0.5068|TWO_SIDED|95.0|-166.1|1478.83||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1478.83|-166.10|0.5068
73928045|NCT01675882|147384628|SUPERIORITY||Difference in LS mean|53.8||||0.7972|TWO_SIDED|95.0|-193.9|1085.38||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1085.38|-193.90|0.7972
73928046|NCT01675882|147384629|SUPERIORITY||Difference in LS mean|120.0||||0.0444|TWO_SIDED|95.0|2.3|321.8||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||321.80|2.30|0.0444
74029415|NCT00410280|147613365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.528|TWO_SIDED|95.0|-1.14|0.59|||Mixed Models Analysis|||Day 35: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.59|-1.14|0.5280
74029416|NCT01522651|147613381|OTHER|Pairwise Comparative analysis|Percentage Difference|-19.8|STANDARD_ERROR_OF_MEAN|25.7||0.493|TWO_SIDED|95.0|-57.5|51.5||An equal-slopes analysis of covariance (ANCOVA) model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||51.5|-57.5|0.493
74029417|NCT01522651|147613381|OTHER|Pairwise Comparative analysis|Percentage Difference|8.8|STANDARD_ERROR_OF_MEAN|32.9||0.78|TWO_SIDED|95.0|-40.2|98.2||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||98.2|-40.2|0.780
74029418|NCT01522651|147613381|OTHER|Pairwise Comparative analysis|Percentage Difference|-57.0|STANDARD_ERROR_OF_MEAN|13.4||0.008|TWO_SIDED|95.0|-76.8|-20.1||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||-20.1|-76.8|0.008
73928047|NCT01675882|147384629|SUPERIORITY||Difference in LS mean|147.6||||0.0175|TWO_SIDED|95.0|19.67|365.51||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||365.51|19.67|0.0175
73928048|NCT01675882|147384629|SUPERIORITY||Difference in LS mean|386.0|||<|0.0001|TWO_SIDED|95.0|159.67|771.16||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||771.16|159.67|<0.0001
73928049|NCT01675882|147384630|SUPERIORITY||Difference in LS mean|-0.6||||0.251|TWO_SIDED|95.0|-1.55|0.52||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||0.52|-1.55|0.2510
73928050|NCT01675882|147384630|SUPERIORITY||Difference in LS mean|-0.2||||0.682|TWO_SIDED|95.0|-1.24|1.05||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1.05|-1.24|0.6820
73928051|NCT01675882|147384630|SUPERIORITY||Difference in LS mean|0.8||||0.2117|TWO_SIDED|95.0|-0.42|2.47||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||2.47|-0.42|0.2117
73928052|NCT01675882|147384632|SUPERIORITY||Difference in LS mean|17.4||||0.0337|TWO_SIDED|95.0|1.17|38.82||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||38.82|1.17|0.0337
73928053|NCT01675882|147384632|SUPERIORITY||Difference in LS mean|26.2||||0.002|TWO_SIDED|95.0|8.38|49.45||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||49.45|8.38|0.0020
73928054|NCT01675882|147384632|SUPERIORITY||Difference in LS mean|20.0||||0.012|TWO_SIDED|95.0|3.85|40.91||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||40.91|3.85|0.0120
73928055|NCT01675882|147384636|SUPERIORITY||Difference in LS mean|1.2|||<|0.0001|TWO_SIDED|95.0|0.72|1.9||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1.90|0.72|<0.0001
73928056|NCT01675882|147384636|SUPERIORITY||Difference in LS mean|1.3|||<|0.0001|TWO_SIDED|95.0|0.79|2.01||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||2.01|0.79|<0.0001
73928057|NCT01675882|147384636|SUPERIORITY||Difference in LS mean|2.1|||<|0.0001|TWO_SIDED|95.0|1.39|3.11||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||3.11|1.39|<0.0001
73928058|NCT00735371|147384647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||ANCOVA|||||||0.0056
73928059|NCT00735371|147384647|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
73928060|NCT00735371|147384647|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
73928061|NCT00735371|147384648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0235||95.0|||||Cochran-Mantel-Haenszel|||||||0.0235
73928062|NCT00735371|147384648|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73928063|NCT00735371|147384648|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73928064|NCT00994448|147384650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.3|STANDARD_ERROR_OF_MEAN|8.6||0.08|TWO_SIDED|95.0|1.8|34.3|||t-test, 2 sided|||t test for mean of days retained in the bupropion versus placebo groups||34.3|1.8|0.08
73928065|NCT00436748|147384653|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Exact|||The null hypothesis for the Darbepoetin Alfa QW group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.||||<0.001
73928066|NCT00436748|147384653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293|||||||Exact|||The null hypothesis for the Darbepoetin Alfa Q2W group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.||||0.293
73928067|NCT01610791|147384669|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in ALT from Baseline to Week 24||||<0.001
73928068|NCT01610791|147384669|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in AST from Baseline to Week 24||||<0.001
73928069|NCT01610791|147384670|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Diffrence in total cholesterol from baseline to Week 24||||<0.001
73928070|NCT01610791|147384670|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in LDL cholesterol from baseline to Week 24||||<0.001
73928071|NCT04164901|147384725|SUPERIORITY||Cox Proportional Hazard|0.39|||<|1e-07|TWO_SIDED|95.0|0.27|0.56|||Kaplan-Meier|||||0.56|0.27|<0.0000001
73928072|NCT04164901|147384728|SUPERIORITY||Odds Ratio (OR)|4.88||||0.003|TWO_SIDED|95.0|1.56|15.25|||Cochran-Mantel-Haenszel||Odds ratio was calculated with placebo as the control (denominator).|||15.25|1.56|0.003
73928073|NCT04164901|147384735|SUPERIORITY||Cox Proportional Hazard|0.35||||2.4e-07|TWO_SIDED|95.0|0.23|0.54|||Kaplan-Meier|||||0.54|0.23|0.00000024
73928074|NCT00449956|147384809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||||95.0|-1.3|-0.06|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.|||-0.06|-1.30|
73928075|NCT00449956|147384809|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 1.2 mmHg|Mean Difference (Final Values)|0.28||||||95.0|-0.22|0.78|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.|||0.78|-0.22|
73928076|NCT02272413|147384832|EQUIVALENCE|The null hypothesis was to be rejected in favor of equivalence if the 2-sided 90% confidence interval (CI) for the ratio in best ORR between the treatments was entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||TWO_SIDED|90.0|0.7697|0.9506|||Log-binomial regression|||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).||0.9506|0.7697|
73928077|NCT02272413|147384832|EQUIVALENCE|Additional analysis of the primary endpoint was performed for Japan according to a local protocol amendment Japan. For the submission in Japan, to conclude on equivalence, the 2-sided 95% CI for the ratio of best ORR between the treatments had to be entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||TWO_SIDED|95.0|0.7543|0.97|||Log-binomial regression|||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).||0.9700|0.7543|
73928078|NCT02272413|147384833|OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.99|1.37|||Score exact method|||At least 1 AE selected for comparability assessment, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.37|0.99|
73928079|NCT02272413|147384833|OTHER||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.88|1.88|||Score exact method|||Infusion reactions, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.88|0.88|
73928080|NCT02272413|147384833|OTHER||Risk Ratio|1.2|||||TWO_SIDED|95.0|0.64|2.32|||Score exact method|||Thromboembolic events, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||2.32|0.64|
73928081|NCT02272413|147384833|OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.51|2.76|||Score exact method|||Febrile neutropenia, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||2.76|0.51|
73928082|NCT02272413|147384833|OTHER||Risk Ratio (RR)|3.43|||||TWO_SIDED|95.0|0.79|32.82|||Score exact method|||Gastrointestinal perforations, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||32.82|0.79|
73928083|NCT02272413|147384833|OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.66|1.39|||Score exact method|||Hypertension, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.39|0.66|
73928084|NCT02272413|147384833|OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.74|1.57|||Score exact method|||Proteinuria, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.57|0.74|
73928085|NCT02272413|147384833|OTHER||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.28|10.79|||Score exact method|||Pulmonary haemorrhage, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||10.79|0.28|
73969886|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||8.5|-7.9|
73928086|NCT02272413|147384833|OTHER||Risk Ratio (RR)|1.24|||||TWO_SIDED|95.0|0.88|1.74|||Score exact method|||Other hemorrhages, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.74|0.88|
73928087|NCT02272413|147384833|OTHER||Risk Ratio (RR)|1.26|||||TWO_SIDED|95.0|0.47|3.57|||Score excat method|||Wound healing complications/ abscesses/ fistulas, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||3.57|0.47|
73928088|NCT02272413|147384834|OTHER||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|1.02|1.45|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.45|1.02|
73928089|NCT02272413|147384835|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|1.0|1.51|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.51|1.00|
73928090|NCT02272413|147384836|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.88|1.48|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.48|0.88|
73928091|NCT01874262|147384923|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
73928092|NCT01524627|147384927|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||||||0.0004
73928093|NCT01524627|147384927|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
73928094|NCT01696435|147384959|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.62|TWO_SIDED|95.0|0.87|1.09||P-value was not adjusted for multiple comparisons. A priori, two-sided tests with an alpha level of 0.025 were used to account for the 2 co-primary outcomes (depression event and mood scores).|Regression, Cox||Active treatment vs. Placebo comparison|||1.09|.87|0.62
74029419|NCT01522651|147613381|OTHER|Pairwise Comparative analysis|Percentage Difference|-42.6|STANDARD_ERROR_OF_MEAN|17.5||0.072|TWO_SIDED|95.0|-68.7|5.2||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||5.2|-68.7|0.072
73928095|NCT01696435|147384959|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.03|TWO_SIDED|95.0|1.01|1.26||P-value was not adjusted for multiple comparisons. A priori, two-sided tests with an alpha level of 0.025 were used to account for the 2 co-primary outcomes (depression event and mood scores).|Regression, Cox||Active treatment vs. Placebo comparison|||1.26|1.01|0.03
73928096|NCT01696435|147384960|SUPERIORITY||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-0.04|0.05|||Mixed Models Analysis|||Test of whether the mean difference in change comparing the treatment groups is different than zero. See full SAP for all details.||0.05|-0.04|
73928097|NCT01696435|147384960|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|||Test of whether the mean difference in change comparing the treatment groups is different than zero. See full SAP for all details.||0.07|-0.01|
73928098|NCT01696435|147384961|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.88|TWO_SIDED|95.0|0.87|1.13||P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.|Regression, Cox||Active treatment vs. Placebo comparison|||1.13|0.87|0.88
73928099|NCT01696435|147384961|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.02|TWO_SIDED|95.0|1.03|1.33||P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.|Regression, Cox||Active treatment vs. Placebo comparison|||1.33|1.03|0.02
73928100|NCT01696435|147384962|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.67|TWO_SIDED|95.0|0.76|1.19|||Regression, Cox||Active treatment vs. Placebo comparison|P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.||1.19|0.76|0.67
73928101|NCT01696435|147384962|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.88|TWO_SIDED|95.0|0.82|1.27|||Regression, Cox||Active treatment vs. Placebo comparison|P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.||1.27|0.82|0.88
73928102|NCT01344369|147384999|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.44|||||TWO_SIDED|90.0|93.08|112.75|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.75|93.08|
73928103|NCT01344369|147385000|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.58|||||TWO_SIDED|90.0|96.66|104.66|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.66|96.66|
74029420|NCT01522651|147613381|OTHER|Pairwise Comparative analysis||||||0.315||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.315
73928104|NCT01344369|147385001|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.85|||||TWO_SIDED|90.0|96.43|105.48|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.48|96.43|
73928105|NCT01344369|147385002|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.59|||||TWO_SIDED|90.0|93.69|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.00|93.69|
73928106|NCT01344369|147385003|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.68|||||TWO_SIDED|90.0|92.76|100.77|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.77|92.76|
73928107|NCT01344369|147385004|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.44|||||TWO_SIDED|90.0|92.22|100.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.84|92.22|
73928108|NCT02223767|147385115|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|||||||0.025
73928109|NCT02223767|147385116|SUPERIORITY|||||||0.08|||||||t-test, 1 sided|||||||0.08
73928110|NCT02342704|147385118|SUPERIORITY_OR_OTHER|||||||0.126|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 4||||0.1260
73928111|NCT02342704|147385118|SUPERIORITY_OR_OTHER|||||||0.3525|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 4||||0.3525
73928112|NCT02342704|147385118|SUPERIORITY_OR_OTHER|||||||0.0127|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 12||||0.0127
73862708|NCT00385723|147271305|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED|95.0|-0.19|-0.028||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months||-0.028|-0.19|0.03
73928113|NCT02342704|147385118|SUPERIORITY_OR_OTHER|||||||0.0299|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 12||||0.0299
73928114|NCT02342704|147385118|SUPERIORITY_OR_OTHER|||||||0.0123|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 24||||0.0123
73928115|NCT02342704|147385118|SUPERIORITY_OR_OTHER|||||||0.0076|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 24||||0.0076
73928116|NCT02342704|147385119|SUPERIORITY_OR_OTHER|||||||0.5318|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T1 Lesion Volume Change||||0.5318
73928117|NCT02342704|147385119|SUPERIORITY_OR_OTHER|||||||0.0528|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T2 Lesion Volume Change||||0.0528
73928118|NCT02342704|147385121|SUPERIORITY_OR_OTHER|||||||0.2632|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||||||0.2632
73928119|NCT02347527|147385130|SUPERIORITY|||||||0.038|||||||ANOVA|||||||0.038
73928120|NCT02347527|147385130|SUPERIORITY|||||||0.036|||||||ANOVA|||||||0.036
73928121|NCT02347527|147385131|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
73928122|NCT02347527|147385132|OTHER|||||||0.04|||||||Pearson's correlation|||Relationship between change in high-calorie food ratings and subsequent food intake (kcals).||||0.040
73928123|NCT02347527|147385132|OTHER|||||||0.92|||||||Pearson's correlation|||Relationship between change in high-calorie food ratings and subsequent food intake (kcals).||||0.92
73928124|NCT00283439|147385137|SUPERIORITY_OR_OTHER|||||||0.9654||||||One-sided test|Satterhwaite t-test|||||||0.9654
73928125|NCT00283439|147385137|SUPERIORITY_OR_OTHER|||||||0.869||||||One-sided test|Satterhwaite t-test|||||||0.8690
73928126|NCT00283439|147385137|SUPERIORITY_OR_OTHER|||||||0.7133||||||One-sided test|Satterhwaite t-test|||||||0.7133
73928127|NCT00283439|147385138|SUPERIORITY_OR_OTHER|||||||0.294|||||||Fisher Exact|||||||0.294
73928128|NCT00283439|147385138|SUPERIORITY_OR_OTHER|||||||0.608|||||||Fisher Exact|||||||0.608
73928129|NCT00283439|147385138|SUPERIORITY_OR_OTHER|||||||0.603|||||||Fisher Exact|||||||0.603
73928130|NCT00283439|147385139|SUPERIORITY_OR_OTHER|||||||0.091|||||||Satterhwaite t-test|||||||0.091
73928131|NCT00283439|147385139|SUPERIORITY_OR_OTHER|||||||0.3|||||||Satterhwaite t-test|||||||0.300
73928132|NCT00283439|147385139|SUPERIORITY_OR_OTHER|||||||0.881|||||||Satterhwaite t-test|||||||0.881
73928133|NCT00283439|147385140|SUPERIORITY_OR_OTHER|||||||0.576|||||||Fisher Exact|||||||0.576
73928134|NCT00283439|147385140|SUPERIORITY_OR_OTHER|||||||0.588|||||||Fisher Exact|||||||0.588
73928135|NCT00283439|147385140|SUPERIORITY_OR_OTHER|||||||0.421|||||||Fisher Exact|||||||0.421
73928136|NCT01632891|147385144|SUPERIORITY|Test used alpha level of 0.05||||||1|||||||Fisher Exact|||Compare proportions of Pf SCP clearance between treatment arms||||1.00
73928137|NCT04206293|147385171|SUPERIORITY||Least Squares (LS) Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.9||0.0736|TWO_SIDED|95.0|-0.2|3.6|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||3.6|-0.2|0.0736
73928138|NCT04206293|147385171|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.0||0.5259|TWO_SIDED|95.0|-1.5|2.8|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||2.8|-1.5|0.5259
73928139|NCT04206293|147385172|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.2||0.8848|TWO_SIDED|95.0|-2.8|2.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||2.4|-2.8|0.8848
73928140|NCT04206293|147385172|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.8||0.9505|TWO_SIDED|95.0|-1.8|1.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.7|-1.8|0.9505
73928141|NCT04206293|147385173|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.6||0.0007|TWO_SIDED|95.0|1.4|4.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||4.0|1.4|0.0007
73928142|NCT04206293|147385173|SUPERIORITY||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.7||0.0033|TWO_SIDED|95.0|0.9|3.9|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||3.9|0.9|0.0033
73928143|NCT04206293|147385174|SUPERIORITY||LS Mean Difference|-0.095|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|-0.119|-0.07|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Uf: Change from Baseline to Day 28||-0.070|-0.119|<0.0001
73928144|NCT04206293|147385174|SUPERIORITY||LS Mean Difference|-0.071|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|-0.094|-0.048|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Uf: Change from Baseline to Day 84||-0.048|-0.094|<0.0001
73928145|NCT04206293|147385174|SUPERIORITY||LS Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.116|-0.061|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ue: Change from Baseline to Day 28||-0.061|-0.116|<0.0001
74088021|NCT00063882|147729956|SUPERIORITY||Effect size|0.4|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary||||<0.0001
73928146|NCT04206293|147385174|SUPERIORITY||LS Mean Difference|-0.081|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|-0.102|-0.061|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ue: Change from Baseline to Day 84||-0.061|-0.102|<0.0001
73928147|NCT04206293|147385174|SUPERIORITY||LS Mean Difference|-0.079|STANDARD_ERROR_OF_MEAN|0.018||0.0003||95.0|-0.116|-0.041|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ur: Change from Baseline to Day 28||-0.041|-0.116|0.0003
73928148|NCT04206293|147385174|SUPERIORITY||LS Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|-0.103|-0.044|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ur: Change from Baseline to Day 84||-0.044|-0.103|0.0001
73928149|NCT04206293|147385174|SUPERIORITY||LS Mean Difference|-0.081|STANDARD_ERROR_OF_MEAN|0.017||0.0002|TWO_SIDED|95.0|-0.117|-0.045|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ua: Change from Baseline to Day 28||-0.045|-0.117|0.0002
73928150|NCT04206293|147385174|SUPERIORITY||LS Mean Difference|-0.077|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.103|-0.052|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ua: Change from Baseline to Day 84||-0.052|-0.103|<0.0001
73928151|NCT04206293|147385175|SUPERIORITY||LS Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.014||0.5786|TWO_SIDED|95.0|-0.038|0.022|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q1: Change from Baseline to Day 28||0.022|-0.038|0.5786
73928152|NCT04206293|147385175|SUPERIORITY||LS Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.012||0.069|TWO_SIDED|95.0|-0.049|0.002|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q1: Change from Baseline to Day 84||0.002|-0.049|0.0690
73928153|NCT04206293|147385175|SUPERIORITY||LS Mean Difference|-0.021|STANDARD_ERROR_OF_MEAN|0.016||0.1934|TWO_SIDED|95.0|-0.054|0.012|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q2: Change from Baseline to Day 28||0.012|-0.054|0.1934
73928154|NCT04206293|147385175|SUPERIORITY||LS Mean Difference|-0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0194|TWO_SIDED|95.0|-0.062|-0.006|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q2: Change from Baseline to Day 84||-0.006|-0.062|0.0194
74088022|NCT00063882|147729956|SUPERIORITY||Effect size|0.09||||0.33|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary- Incontinence||||0.33
74088023|NCT00063882|147729956|SUPERIORITY||Effect size|0.44|||<|0.0001|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Irritative||||<0.0001
73928155|NCT04206293|147385175|SUPERIORITY||LS Mean Difference|0.013|STANDARD_ERROR_OF_MEAN|0.007||0.0652|TWO_SIDED|95.0|-0.001|0.028|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q3: Change from Baseline to Day 28||0.028|-0.001|0.0652
74029421|NCT01522651|147613381|OTHER|Pairwise Comparative analysis||||||0.049||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.049
73928156|NCT04206293|147385175|SUPERIORITY||LS Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.006||0.0756|TWO_SIDED|95.0|-0.001|0.024|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q3: Change from Baseline to Day 84||0.024|-0.001|0.0756
73969887|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||7.9|-8.1|
73969888|NCT03848065|147479636|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|6.3|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||6.3|-11.9|
73969889|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||8.5|-7.9|
73969890|NCT03848065|147479636|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||5.8|-11.9|
73969891|NCT03848065|147479636|OTHER||Difference in Percentages|-9.1|||||TWO_SIDED|95.0|-21.2|-0.2|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||-0.2|-21.2|
73969892|NCT03848065|147479636|OTHER||Difference in Percentages|-6.7|||||TWO_SIDED|95.0|-17.9|2.1|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||2.1|-17.9|
73969893|NCT03848065|147479636|OTHER||Difference in Percentages|-2.4|||||TWO_SIDED|95.0|-15.6|10.2|||||Difference=% V114 SC minus % V114 IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||10.2|-15.6|
73969894|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114 SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||8.5|-8.1|
73969895|NCT03848065|147479636|OTHER||Difference in Percentages|-2.2|||||TWO_SIDED|95.0|-11.7|6.3|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||6.3|-11.7|
73928157|NCT04206293|147385176|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|2.68||0.8409|TWO_SIDED|95.0|-6.19|5.1|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||5.10|-6.19|0.8409
73928158|NCT04206293|147385176|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|3.98||0.9183|TWO_SIDED|95.0|-9.18|8.35|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||8.35|-9.18|0.9183
73969896|NCT03848065|147479636|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-6.0|11.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||11.6|-6.0|
73969897|NCT03848065|147479636|OTHER||Differences in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||8.5|-8.1|
73969898|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||8.5|-7.9|
73969899|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||7.9|-8.1|
73969900|NCT03848065|147479636|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|6.3|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||6.3|-11.9|
73969901|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||8.5|-7.9|
73969902|NCT03848065|147479636|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||5.8|-11.9|
73969903|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||8.5|-8.1|
73969904|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||8.5|-7.9|
73969905|NCT03848065|147479636|OTHER||Differences in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||7.9|-8.1|
73969906|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||8.5|-8.1|
73969907|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||8.5|-7.9|
73969908|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||7.9|-8.1|
73969909|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||8.5|-8.1|
73969910|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||8.5|-7.9|
74029422|NCT01522651|147613381|OTHER|Pairwise Comparative analysis||||||0.275||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.275
74029423|NCT01522651|147613381|OTHER|Pairwise Comparative analysis||||||0.002||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.002
74088024|NCT00063882|147729956|SUPERIORITY||Effect size|0.31||||0.001|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Bowel||||0.001
74088025|NCT00063882|147729956|SUPERIORITY||Effect size|0.12||||0.23|TWO_SIDED||||||t-test, 2 sided|||Sexual|Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|||0.23
73928159|NCT04206293|147385177|SUPERIORITY||LS Mean Difference|70.0|STANDARD_ERROR_OF_MEAN|77.0||0.4128|TWO_SIDED|95.0|-142.0|282.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||282|-142|0.4128
73928160|NCT04206293|147385177|SUPERIORITY||LS Mean Difference|-82.0|STANDARD_ERROR_OF_MEAN|79.0||0.3851|TWO_SIDED|95.0|-355.0|191.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||191|-355|0.3851
73928161|NCT04206293|147385178|SUPERIORITY||LS Mean Difference|6.52|STANDARD_ERROR_OF_MEAN|3.44||0.0798|TWO_SIDED|95.0|-0.89|13.93|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||13.93|-0.89|0.0798
73969911|NCT03848065|147479636|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||7.9|-8.1|
73969912|NCT03848065|147479636|OTHER||Difference in Percentages|0.1|||||TWO_SIDED|95.0|-9.8|10.4|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||10.4|-9.8|
73969913|NCT03848065|147479636|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.7|12.4|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||12.4|-5.7|
73928162|NCT04206293|147385178|SUPERIORITY||LS Mean Difference|5.56|STANDARD_ERROR_OF_MEAN|3.27||0.1142|TWO_SIDED|95.0|-1.55|12.67|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||12.67|-1.55|0.1142
73928163|NCT04206293|147385179|SUPERIORITY||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.82||0.2592|TWO_SIDED|95.0|-0.78|2.71|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ra: Change from Baseline to Day 28||2.71|-0.78|0.2592
73928164|NCT04206293|147385179|SUPERIORITY||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.69||0.1341|TWO_SIDED|95.0|-0.38|2.57|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ra: Change from Baseline to Day 84||2.57|-0.38|0.1341
73928165|NCT04206293|147385179|SUPERIORITY||LS Mean Difference|5.91|STANDARD_ERROR_OF_MEAN|4.55||0.2138|TWO_SIDED|95.0|-3.79|15.61|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Rz: Change from Baseline to Day 28||15.61|-3.79|0.2138
73928166|NCT04206293|147385179|SUPERIORITY||LS Mean Difference|8.22|STANDARD_ERROR_OF_MEAN|4.2||0.07|TWO_SIDED|95.0|-0.77|17.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Rz: Change from Baseline to Day 84||17.20|-0.77|0.0700
73928167|NCT04206293|147385180|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|2.17||0.9608|TWO_SIDED|95.0|-4.7|4.91|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||4.91|-4.70|0.9608
73928168|NCT04206293|147385180|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|2.79||0.6192|TWO_SIDED|95.0|-7.48|4.64|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||4.64|-7.48|0.6192
73928169|NCT04206293|147385181|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.08||0.8322|TWO_SIDED|95.0|-0.2|0.16|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.16|-0.20|0.8322
73969914|NCT03848065|147479636|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||5.8|-11.9|
73969915|NCT03848065|147479636|OTHER||Difference in Percentages|90.7|||||TWO_SIDED|95.0|77.2|96.4|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||96.4|77.2|
73969916|NCT03848065|147479636|OTHER||Difference in Percentages|95.2|||||TWO_SIDED|95.0|84.1|98.7|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||98.7|84.1|
73969917|NCT03848065|147479636|OTHER||Difference in Percentages|-4.5|||||TWO_SIDED|95.0|-15.2|3.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||3.6|-15.2|
73969918|NCT03848065|147479636|OTHER||Difference in Percentages|81.8|||||TWO_SIDED|95.0|67.9|90.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||90.5|67.9|
73969919|NCT03848065|147479636|OTHER||Difference in Percentages|88.9|||||TWO_SIDED|95.0|76.4|95.2|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||95.2|76.4|
73969920|NCT03848065|147479636|OTHER||Difference in Percentages|-7.1|||||TWO_SIDED|95.0|-22.7|8.2|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||8.2|-22.7|
74088026|NCT00063882|147729957|SUPERIORITY||Effect size|0.38||||0.0002|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary||||0.0002
74088027|NCT00063882|147729957|SUPERIORITY||Effect size|0.08||||0.42|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Incontinence||||0.42
73928170|NCT04206293|147385181|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.1334|TWO_SIDED|95.0|-0.25|0.04|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.04|-0.25|0.1334
73928171|NCT04206293|147385182|SUPERIORITY||LS Mean Difference|-5.09|STANDARD_ERROR_OF_MEAN|7.78||0.5221|TWO_SIDED|95.0|-21.56|11.38|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||11.38|-21.56|0.5221
73928172|NCT04206293|147385182|SUPERIORITY||LS Mean Difference|6.74|STANDARD_ERROR_OF_MEAN|8.07||0.4174|TWO_SIDED|95.0|-10.55|24.03|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||24.03|-10.55|0.4174
73928173|NCT04206293|147385183|SUPERIORITY||LS Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|2.58||0.3052|TWO_SIDED|95.0|-2.9|8.44|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||8.44|-2.90|0.3052
73928174|NCT04206293|147385183|SUPERIORITY||LS Mean Difference|9.99|STANDARD_ERROR_OF_MEAN|2.57||0.0016|TWO_SIDED|95.0|4.48|15.5|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||15.50|4.48|0.0016
73969921|NCT03848065|147479637|OTHER||Geometric Mean Concentration (GMC) Ratio|0.76|||||TWO_SIDED|95.0|0.58|1.0|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an analysis of variance (ANOVA) model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 1||1.00|0.58|
73928175|NCT04206293|147385184|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.48||0.1672|TWO_SIDED|95.0|-0.33|1.73|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||1.73|-0.33|0.1672
73928176|NCT04206293|147385184|SUPERIORITY||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.29||0.0881|TWO_SIDED|95.0|-0.1|1.21|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.21|-0.10|0.0881
73928177|NCT04206293|147385185|SUPERIORITY||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.28||0.0577|TWO_SIDED|95.0|-0.02|1.17|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||1.17|-0.02|0.0577
73928178|NCT04206293|147385185|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.5224|TWO_SIDED|95.0|-0.85|0.45|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.45|-0.85|0.5224
73928179|NCT04206293|147385186|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2666|TWO_SIDED|95.0|-0.6|0.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.2|-0.6|0.2666
73928180|NCT04206293|147385186|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4366|TWO_SIDED|95.0|-0.3|0.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.7|-0.3|0.4366
73928181|NCT04206293|147385187|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4197|TWO_SIDED|95.0|-0.6|0.3|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||a\*: Change from Baseline to Day 28||0.3|-0.6|0.4197
73928182|NCT04206293|147385187|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.914|TWO_SIDED|95.0|-0.6|0.5|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||a\*: Change from Baseline to Day 84||0.5|-0.6|0.9140
73928183|NCT04206293|147385187|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7604|TWO_SIDED|95.0|-0.6|0.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||b\*: Change from Baseline to Day 28||0.4|-0.6|0.7604
73928184|NCT04206293|147385187|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.5936|TWO_SIDED|95.0|-1.0|0.6|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||b\*: Change from Baseline to Day 84||0.6|-1.0|0.5936
73928185|NCT04206293|147385187|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0808|TWO_SIDED|95.0|-0.9|0.1|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||L\*: Change from Baseline to Day 28||0.1|-0.9|0.0808
73928186|NCT04206293|147385187|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1633|TWO_SIDED|95.0|-1.0|0.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||L\*: Change from Baseline to Day 84||0.2|-1.0|0.1633
73928187|NCT04206293|147385188|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.1977|TWO_SIDED|95.0|-1.6|0.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.4|-1.6|0.1977
73969922|NCT03848065|147479637|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.13|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|||1.13|0.65|
73928188|NCT04206293|147385188|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.7535|TWO_SIDED|95.0|-2.2|1.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.7|-2.2|0.7535
73969923|NCT03848065|147479637|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.68|1.16|||||GMC Ratio=GMC V114-SC/GMC V114-IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|||1.16|0.68|
73862709|NCT00385723|147271305|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.004|TWO_SIDED|95.0|-0.22|-0.052||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||-0.052|-0.22|0.004
73928189|NCT04206293|147385189|SUPERIORITY||LS Mean Difference|4.35|STANDARD_ERROR_OF_MEAN|3.95||0.2905|TWO_SIDED|95.0|-4.16|12.85|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||12.85|-4.16|0.2905
73928190|NCT04206293|147385189|SUPERIORITY||LS Mean Difference|17.27|STANDARD_ERROR_OF_MEAN|6.37||0.0241|TWO_SIDED|95.0|2.84|31.69|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||31.69|2.84|0.0241
73928191|NCT01454934|147385205|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.1343|TWO_SIDED|95.0|0.95|1.41||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||Hazard Ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||1.41|0.95|0.1343
73928192|NCT01454934|147385206|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.3946|TWO_SIDED|95.0|0.9|1.32||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||The hazard ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option, and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||1.32|0.90|0.3946
73969924|NCT03848065|147479637|OTHER||GMC Ratio|1.3|||||TWO_SIDED|95.0|0.96|1.76|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||1.76|0.96|
73969925|NCT03848065|147479637|OTHER||GMC Ratio|1.49|||||TWO_SIDED|95.0|1.1|2.01|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||2.01|1.10|
73969926|NCT03848065|147479637|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.65|1.18|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||1.18|0.65|
73928193|NCT01454934|147385207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3034||||||The P-value was stratified by histology, TPC option, and geographic region.|Cochran-Mantel-Haenszel|||OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||||0.3034
73928194|NCT00430092|147385208|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mantel Haenszel|||||||<0.0001
73928195|NCT02624284|147385291|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on latency to smoke. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.94|||||||Regression, Linear|||||||0.94
73928196|NCT02624284|147385292|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on number of cigarettes smoked. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.53|||||||Regression, Linear|||||||0.53
73928197|NCT02624284|147385294|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on days of abstinence. Age, sex, race and nicotine dependence were included as covariates.||||||0.78|||||||Regression, Linear|||||||0.78
73928198|NCT00048542|147385392|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Chi-square test|||The study was sized to detect a difference in the proportion of subjects (40%) between placebo and the active adalimumab dose group who would experience disease flare assuming a placebo rate of 70% vs. a rate of 30% in the active group. Assuming a binomial distribution, an alpha of 0.05, 80% power, two-sided test, and an initial monotherapy responder rate of 70%, a minimum of 29 subjects were needed per treatment group within the appropriate strata.||||0.031
73928199|NCT00048542|147385394|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-square test|||||||0.015
73928200|NCT00048542|147385395|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Log Rank|||||||0.029
73928201|NCT00048542|147385396|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Log Rank|||||||0.031
73928202|NCT00048542|147385397|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Pearson's Chi-square test|||||||0.061
73928203|NCT00048542|147385397|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Pearson's Chi-square test|||||||0.028
73928204|NCT00048542|147385398|SUPERIORITY_OR_OTHER|||||||0.103||95.0|||||Pearson's Chi-square test|||||||0.103
73928205|NCT00048542|147385398|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Pearson's Chi-square test|||||||0.028
73928206|NCT00048542|147385399|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||Pearson's Chi-square test|||||||0.156
73928207|NCT00048542|147385399|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Pearson's Chi-square test|||||||0.002
73928208|NCT02462967|147385440|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
73969927|NCT03848065|147479637|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.58|0.9|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||0.90|0.58|
73969928|NCT03848065|147479637|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.65|1.0|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||1.00|0.65|
73969929|NCT03848065|147479637|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.72|1.11|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||1.11|0.72|
73969930|NCT03848065|147479637|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.6|1.16|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.16|0.60|
73928209|NCT02462967|147385440|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
73928210|NCT02462967|147385441|SUPERIORITY|||||||0.447|||||||ANCOVA|||||||0.447
73928211|NCT02462967|147385441|SUPERIORITY|||||||0.921|||||||ANCOVA|||||||0.921
73928212|NCT02462967|147385442|SUPERIORITY|||||||0.522|||||||ANCOVA|||||||0.522
73928213|NCT02462967|147385442|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
73928214|NCT02462967|147385443|SUPERIORITY|||||||0.943|||||||ANCOVA|||||||0.943
73969931|NCT03848065|147479637|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.69|1.31|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.31|0.69|
73928215|NCT02462967|147385443|SUPERIORITY|||||||0.492|||||||ANCOVA|||||||0.492
73928216|NCT02462967|147385444|SUPERIORITY|||||||0.832|||||||ANCOVA|||||||0.832
73928217|NCT02462967|147385444|SUPERIORITY|||||||0.558|||||||ANCOVA|||||||0.558
73928218|NCT02462967|147385445|SUPERIORITY|||||||0.362|||||||ANCOVA|||||||0.362
73928219|NCT02462967|147385445|SUPERIORITY|||||||0.602|||||||ANCOVA|||||||0.602
73928220|NCT02462967|147385446|SUPERIORITY|||||||0.633|||||||Chi-squared|||||||0.633
73928221|NCT02462967|147385446|SUPERIORITY|||||||0.814|||||||Chi-squared|||||||0.814
73928222|NCT00544076|147385501|EQUIVALENCE|The equivalence margin that would be possible to detect (had the protocol reached intended accrual) was 20%,|||||>|0.1||||||no adjustments were made.|Fisher Exact|||||||>0.1
73928223|NCT00544076|147385502|OTHER||||||>|0.1||||||no adjustments done|Chi-squared|no adjustments||compare percentage of patients potent at 6 and 18 months across pairs of treatment arms (arm I vs arm II, arm I vs arm III, arm II vs arm III)||||>0.1
73928224|NCT00544076|147385503|OTHER||||||>|0.2||||||no adjustments done.|ANOVA|||||||>0.2
73928225|NCT00544076|147385504|OTHER||Mean Difference (Final Values)|0.08||||0.08|TWO_SIDED|||||no adjustments|ANOVA|no adjustments for df||"ANOVA test to compare difference of penile length (from baseline to month 18) across arms.~calculations are underpowered, as study did not accrue or retain patients as intended, and many patients declined to have measurements taken."||||0.08
73928226|NCT00847288|147385528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.0043|TWO_SIDED|95.0|1.1|2.0||Cox proportional hazard model was fitted with the group effect and other key baseline variables. The p-value for the main group effect is 0.0043, with an estimated hazard ratio of 1.5, monthly vs quarterly.|Regression, Cox|||"Let TM and TQ denote the median survival time to initiation of clinical action in monthly and quarterly review groups respectively. Null Hypothesis (HO): The time to initiation of clinical action is not affected by review frequency (monthly versus quarterly): TM=TQ Alternative Hypothesis (HA): The time to initiation of clinical action is affected by review frequency (monthly versus quarterly): TM≠TQ~Cox proportional hazard model will be fitted to estimate the hazard ratio."||2.0|1.1|0.0043
73928227|NCT00847288|147385530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0001|TWO_SIDED|95.0|1.2|1.74|||logistic GEE for repeated observations|||The probability of action taken in three months interval is evaluated using the generalized estimating equations (GEE) method under a logistic regression model. Univariate analysis is performed first for potential predictors and only those with a p-value less than 0.10 through univariate analysis are included in the multivariate model. Here we report the odds ratio of monthly arm against quarterly arm, adjusting for OptiVol crossing, new or chronic device, and AF or no AF.||1.74|1.20|0.0001
73928228|NCT03274986|147385593|SUPERIORITY||Least Squares Mean Difference|-0.164|STANDARD_ERROR_OF_MEAN|0.0168|<|0.001|TWO_SIDED|95.0|-0.197|-0.131||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.131|-0.197|<0.001
73928229|NCT03274986|147385594|NON_INFERIORITY|Non-Inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.052|STANDARD_ERROR_OF_MEAN|0.0127|||ONE_SIDED|95.0||0.073||The hypothesis test was based on a two-sample t-test, with a type I error rate of 0.05, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF). The 1-sided 95% Upper Confidence Limit is presented.|||0.073||
73928230|NCT03274986|147385595|OTHER||Difference in depth of focus|0.54|||||TWO_SIDED|||||Hypothesis testing was not pre-specified.|||Difference in depth of focus (DFT015 - SN60WF)|||||
73928231|NCT03274986|147385599|SUPERIORITY||Least Squares Mean Difference|-0.156|STANDARD_ERROR_OF_MEAN|0.0206|<|0.001|TWO_SIDED|95.0|-0.197|-0.115||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.115|-0.197|<0.001
73928232|NCT03274986|147385600|OTHER||Difference in percentage|18.0|||||TWO_SIDED|95.0|9.65|27.37|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||27.37|9.65|
73928233|NCT00403273|147385650|SUPERIORITY|||||||0.01||||||p-value not adjusted for multiple comparisons; the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.01
73928234|NCT00403273|147385651|SUPERIORITY_OR_OTHER||comparison of proportions|0.65|||<|0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons was made, since we analyzed only one primary outcome. 19 patients per group were needed for 80% power and 24 patients per group for 90% power to detect a difference of 43% in proportion with primary outcome|comparison of proportions|compare proportion of patients with clinically meaningful change in 0-10 VAS pain (at least 2-point reduction on VAS pain) at 2-mths \& all timepoints|we hypothesized a greater proportion with meaningful reduction in pain on 0-10 scale in intervention versus placebo group.|For primary outcome analysis, we compared the proportion of responders with clinically meaningful change \[improvement\] in 0-10 VAS Pain, i.e. those with 2-point reduction in 0-10 VAS pain score at 2-mths, in the 2 groups using comparison of proportions. Proportion of responders were also analyzed at all efficacy timepoints using generalized estimating equation (GEE) modeling. We used GEE for between-group comparisons in secondary outcomes at all efficacy endpoints, adjusted for baseline scores.||||<0.05
73928235|NCT00403273|147385652|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
73928236|NCT00403273|147385653|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
73928237|NCT00403273|147385654|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
73928238|NCT00403273|147385655|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
73928239|NCT00403273|147385656|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
73969932|NCT03848065|147479637|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.21|0.64|
74088028|NCT00063882|147729957|SUPERIORITY||Effect size|0.44|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Irritative||||<0.0001
74088029|NCT00063882|147729957|SUPERIORITY||Effect size|0.42|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Bowel||||<0.0001
74088030|NCT00063882|147729957|SUPERIORITY||Effect size|0.27||||0.0072|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Sexual||||0.0072
74088031|NCT01103479|147729963|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.65||||0.32|TWO_SIDED|95.0|0.62|4.38||Random effects model adjusting for clustering by clinic|Mixed Models Analysis|||||4.38|0.62|0.32
74088032|NCT01103479|147729964|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8||||0.28|TWO_SIDED|95.0|0.53|1.2||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis|||||1.20|0.53|0.28
74088033|NCT01103479|147729965|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43||||0.42|TWO_SIDED|95.0|0.6|3.43||Random effects model adjusted for clustering by clinic|Mixed Models Analysis|||||3.43|0.60|0.42
74088034|NCT01103479|147729966|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.05||||0.38|TWO_SIDED|95.0|0.94|1.18||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis|||||1.18|0.94|0.38
73928240|NCT01336738|147385662|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.164||0.6803|TWO_SIDED|80.0|-0.13|0.29||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on LS mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.29|-0.13|0.6803
74088035|NCT02709486|147729967|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0088|TWO_SIDED|95.0|-0.81|-0.12||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.12|-0.81|0.0088
74088036|NCT02709486|147729967|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18||0.0006|TWO_SIDED|95.0|-0.97|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.97|0.0006
73928241|NCT01336738|147385662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.166||0.0017|TWO_SIDED|80.0|-0.71|-0.28||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.28|-0.71|0.0017
74088037|NCT02709486|147729968|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.18||0.0008|TWO_SIDED|95.0|-0.93|-0.24||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-0.93|0.0008
74088038|NCT02709486|147729968|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.36||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.36|-1.05|<.0001
73928242|NCT01336738|147385662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.168||0.0003|TWO_SIDED|80.0|-0.8|-0.36||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.36|-0.80|0.0003
74088039|NCT02709486|147729969|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.1092|TWO_SIDED|95.0|-0.24|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.24|0.1092
73928243|NCT01336738|147385662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.162|<|0.0001|TWO_SIDED|80.0|-0.91|-0.5||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.50|-0.91|<0.0001
73928244|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|5.292||0.4757|TWO_SIDED|95.0|-6.64|14.2||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||14.20|-6.64|0.4757
73928245|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|5.296||0.8031|TWO_SIDED|95.0|-9.11|11.75||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.75|-9.11|0.8031
73928246|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.22|STANDARD_ERROR_OF_MEAN|5.364||0.549|TWO_SIDED|95.0|-13.78|7.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.34|-13.78|0.5490
73928247|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.07|STANDARD_ERROR_OF_MEAN|5.34||0.0051|TWO_SIDED|95.0|-25.58|-4.55||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.55|-25.58|0.0051
73928248|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|5.02||0.6291|TWO_SIDED|95.0|-12.31|7.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.46|-12.31|0.6291
73928249|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|STANDARD_ERROR_OF_MEAN|5.001||0.4396|TWO_SIDED|95.0|-5.98|13.72||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.72|-5.98|0.4396
73928250|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.56|STANDARD_ERROR_OF_MEAN|5.03||0.1934|TWO_SIDED|95.0|-16.46|3.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.34|-16.46|0.1934
73928251|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.32|STANDARD_ERROR_OF_MEAN|5.039||0.0007|TWO_SIDED|95.0|-27.24|-7.4||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.40|-27.24|0.0007
73928252|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|5.201||0.5479|TWO_SIDED|95.0|-7.11|13.37||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.37|-7.11|0.5479
73928253|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.14|STANDARD_ERROR_OF_MEAN|5.209||0.4276|TWO_SIDED|95.0|-14.39|6.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||6.12|-14.39|0.4276
73928254|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.38|STANDARD_ERROR_OF_MEAN|5.235||0.1596|TWO_SIDED|95.0|-17.69|2.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.92|-17.69|0.1596
73928255|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.83|STANDARD_ERROR_OF_MEAN|5.198|<|0.0001|TWO_SIDED|95.0|-33.06|-12.6||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-12.60|-33.06|<0.0001
73969933|NCT03848065|147479637|OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.47|0.84|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||0.84|0.47|
73928256|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.855||0.8509|TWO_SIDED|95.0|-12.63|10.43||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||10.43|-12.63|0.8509
73928257|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.53|STANDARD_ERROR_OF_MEAN|5.913||0.1505|TWO_SIDED|95.0|-20.17|3.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.12|-20.17|0.1505
73928258|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.62|STANDARD_ERROR_OF_MEAN|5.94||0.2662|TWO_SIDED|95.0|-18.31|5.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.08|-18.31|0.2662
73928259|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.52|STANDARD_ERROR_OF_MEAN|5.818||0.0003|TWO_SIDED|95.0|-32.97|-10.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-10.07|-32.97|0.0003
73928260|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|6.94||0.7724|TWO_SIDED|95.0|-15.68|11.66||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.66|-15.68|0.7724
73969934|NCT03848065|147479637|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.52|0.93|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||0.93|0.52|
73969935|NCT03848065|147479637|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.68|1.21|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||1.21|0.68|
73862710|NCT00385723|147271306|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.41|STANDARD_ERROR_OF_MEAN|0.1||0.0003|TWO_SIDED|95.0|-0.62|-0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months.||-0.21|-0.62|0.0003
73928261|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|6.986||0.9202|TWO_SIDED|95.0|-14.47|13.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.07|-14.47|0.9202
73928262|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|6.998||0.8183|TWO_SIDED|95.0|-15.4|12.18||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.18|-15.40|0.8183
73928263|NCT01336738|147385663|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.96|STANDARD_ERROR_OF_MEAN|6.821||0.0003|TWO_SIDED|95.0|-38.4|-11.53||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-11.53|-38.40|0.0003
73928264|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.048||0.2327|TWO_SIDED|80.0|-0.1|0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.03|-0.10|0.2327
73928265|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.048||0.358|TWO_SIDED|80.0|-0.08|0.04||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.04|-0.08|0.3580
73928266|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.049||0.0036|TWO_SIDED|80.0|-0.2|-0.07||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.07|-0.20|0.0036
73928267|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.049||0.1251|TWO_SIDED|80.0|-0.12|0.01||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.01|-0.12|0.1251
73928268|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.066||0.3466|TWO_SIDED|80.0|-0.11|0.06||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.06|-0.11|0.3466
73969936|NCT03848065|147479637|OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.36|0.79|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||0.79|0.36|
73969937|NCT03848065|147479637|OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.41|0.9|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||0.90|0.41|
73928269|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.066||0.0439|TWO_SIDED|80.0|-0.2|-0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.03|-0.20|0.0439
73928270|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.067||0.004|TWO_SIDED|80.0|-0.27|-0.09||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.27|0.0040
73928271|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.065||0.0009|TWO_SIDED|80.0|-0.29|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.12|-0.29|0.0009
73969938|NCT03848065|147479637|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.59|1.3|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||1.30|0.59|
74088040|NCT02709486|147729969|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.0051|TWO_SIDED|95.0|-0.32|-0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.32|0.0051
73928272|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.096||0.1405|TWO_SIDED|80.0|-0.23|0.02||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.23|0.1405
73969939|NCT03848065|147479637|OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.46|0.81|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||0.81|0.46|
73969940|NCT03848065|147479637|OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.52|0.9|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||0.90|0.52|
73969941|NCT03848065|147479637|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.67|1.17|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||1.17|0.67|
73969942|NCT03848065|147479637|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.57|0.99|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||0.99|0.57|
73969943|NCT03848065|147479637|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.13|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||1.13|0.65|
73969944|NCT03848065|147479637|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.67|1.15|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||1.15|0.67|
73969945|NCT03848065|147479637|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.6|1.19|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.19|0.60|
73969946|NCT03848065|147479637|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.72|1.43|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.43|0.72|
73969947|NCT03848065|147479637|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.59|1.16|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.16|0.59|
73969948|NCT03848065|147479637|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.53|0.9|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||0.90|0.53|
73969949|NCT03848065|147479637|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.54|0.92|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||0.92|0.54|
73969950|NCT03848065|147479637|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.76|1.27|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||1.27|0.76|
73969951|NCT03848065|147479637|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.66|1.15|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||1.15|0.66|
74088041|NCT02709486|147729970|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.94|-0.4|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-0.94|<.0001
73928273|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.097||0.0067|TWO_SIDED|80.0|-0.36|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.12|-0.36|0.0067
73928274|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.098||0.0001|TWO_SIDED|80.0|-0.5|-0.24||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.24|-0.50|0.0001
73928275|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.094||0.0002|TWO_SIDED|80.0|-0.46|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.22|-0.46|0.0002
73928276|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.135||0.4887|TWO_SIDED|80.0|-0.18|0.17||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.17|-0.18|0.4887
73928277|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.137||0.002|TWO_SIDED|80.0|-0.57|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.22|-0.57|0.0020
73928278|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|80.0|-0.76|-0.41||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.41|-0.76|<0.0001
73928279|NCT01336738|147385664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|80.0|-0.76|-0.42||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.42|-0.76|<0.0001
73928280|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.225||0.2067|TWO_SIDED|95.0|-0.16|0.73||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.73|-0.16|0.2067
73969952|NCT03848065|147479637|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.55|0.96|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||0.96|0.55|
73969953|NCT03848065|147479637|OTHER||GMC Ratio|1.19|||||TWO_SIDED|95.0|0.9|1.57|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||1.57|0.90|
73969954|NCT03848065|147479637|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.57|0.89|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||0.89|0.57|
73969955|NCT03848065|147479637|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.62|0.95|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||0.95|0.62|
73969956|NCT03848065|147479637|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.75|1.15|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||1.15|0.75|
73969957|NCT03848065|147479637|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.57|1.09|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.09|0.57|
73969958|NCT03848065|147479637|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.58|1.09|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.09|0.58|
73969959|NCT03848065|147479637|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.73|1.36|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.36|0.73|
74088042|NCT02709486|147729970|SUPERIORITY||Least Square Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.0149|TWO_SIDED|95.0|-0.61|-0.07|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.07|-0.61|0.0149
73928281|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.224||0.8602|TWO_SIDED|95.0|-0.4|0.48||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.48|-0.40|0.8602
73928282|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.225||0.92|TWO_SIDED|95.0|-0.47|0.42||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.42|-0.47|0.9200
73928283|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.223||0.0399|TWO_SIDED|95.0|0.02|0.9||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.90|0.02|0.0399
73928284|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.242||0.2266|TWO_SIDED|95.0|-0.18|0.77||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.77|-0.18|0.2266
73928285|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.241||0.8493|TWO_SIDED|95.0|-0.43|0.52||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.43|0.8493
73928286|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.242||0.9511|TWO_SIDED|95.0|-0.49|0.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.46|-0.49|0.9511
73969960|NCT03848065|147479637|OTHER||GMC Ratio|134.88|||||TWO_SIDED|95.0|88.91|204.62|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||204.62|88.91|
73969961|NCT03848065|147479637|OTHER||GMC Ratio|204.6|||||TWO_SIDED|95.0|135.18|309.69|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||309.69|135.18|
73969962|NCT03848065|147479637|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.44|0.99|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||0.99|0.44|
73969963|NCT03848065|147479637|OTHER||GMC Ratio|25.11|||||TWO_SIDED|95.0|15.34|41.13|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||41.13|15.34|
73969964|NCT03848065|147479637|OTHER||GMC Ratio|34.18|||||TWO_SIDED|95.0|20.93|55.83|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||55.83|20.93|
73969965|NCT03848065|147479637|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.45|1.19|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||1.19|0.45|
73928287|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.241||0.1369|TWO_SIDED|95.0|-0.11|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.83|-0.11|0.1369
73928288|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.272||0.1562|TWO_SIDED|95.0|-0.15|0.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.92|-0.15|0.1562
73928289|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.272||0.4913|TWO_SIDED|95.0|-0.72|0.35||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.35|-0.72|0.4913
73928290|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.272||0.513|TWO_SIDED|95.0|-0.36|0.71||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.71|-0.36|0.5130
73969966|NCT03848065|147479638|OTHER||Difference in Percentages|2.5|||||TWO_SIDED|95.0|-7.7|13.9|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||13.9|-7.7|
73969967|NCT03848065|147479638|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-10.8|12.0|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||12.0|-10.8|
73969968|NCT03848065|147479638|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-8.0|13.0|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||13.0|-8.0|
73969969|NCT03848065|147479638|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.8|12.4|||||Difference = % V114 SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||12.4|-5.8|
73969970|NCT03848065|147479638|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.7|12.4|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||12.4|-5.7|
73969971|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||7.9|-8.1|
73862711|NCT00385723|147271306|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.43|STANDARD_ERROR_OF_MEAN|0.11||0.0002|TWO_SIDED|95.0|-0.64|-0.22||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||-0.22|-0.64|0.0002
73928291|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.269||0.0298|TWO_SIDED|95.0|0.06|1.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.12|0.06|0.0298
73928292|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.363||0.3196|TWO_SIDED|95.0|-0.35|1.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.08|-0.35|0.3196
73928293|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.367||0.8884|TWO_SIDED|95.0|-0.77|0.67||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.67|-0.77|0.8884
73928294|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.365||0.7325|TWO_SIDED|95.0|-0.59|0.84||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.84|-0.59|0.7325
73928295|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.357||0.3395|TWO_SIDED|95.0|-0.36|1.04||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.04|-0.36|0.3395
73928296|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.41||0.7514|TWO_SIDED|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.68|0.7514
73928297|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.413||0.7529|TWO_SIDED|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.68|0.7529
73928298|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.411||0.9638|TWO_SIDED|95.0|-0.79|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.83|-0.79|0.9638
73928299|NCT01336738|147385666|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67|STANDARD_ERROR_OF_MEAN|0.404||0.0962|TWO_SIDED|95.0|-0.12|1.47||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.47|-0.12|0.0962
73928300|NCT03003520|147385671|SUPERIORITY||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact|||||||>0.99
73928301|NCT03003520|147385671|SUPERIORITY||AUC-ROC|0.477||||0.872|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their CD8 density.||||0.872
73928302|NCT03003520|147385672|SUPERIORITY|||||||0.0403||||||Significance defined as 0.05.|Fisher Exact|||||||0.0403
73969972|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||8.5|-8.1|
73969973|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||8.5|-7.9|
73928303|NCT03003520|147385672|SUPERIORITY||AUC-ROC|0.583||||0.523|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of total cells.||||0.523
73969974|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114 SC minus % V114 IM. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||7.9|-8.1|
73928304|NCT03003520|147385673|SUPERIORITY||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact|||||||>0.99
73928305|NCT03003520|147385673|SUPERIORITY||AUC-ROC|0.583||||0.557|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of tumor cells.||||0.557
73928306|NCT03003520|147385674|SUPERIORITY|||||||0.662||||||Significance defined as 0.05.|Fisher Exact|||||||0.662
73969975|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||8.5|-8.1|
73969976|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||8.5|-7.9|
73969977|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||7.9|-8.1|
73969978|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||8.5|-8.1|
73928307|NCT03003520|147385674|SUPERIORITY||AUC-ROC|0.6||||0.399|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their IFNG-Score.||||0.399
73928308|NCT01332149|147385677|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.148||0.0559|TWO_SIDED|95.0|-0.58|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. No multiple comparisons adjustment was made.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.01|-0.58|0.0559
73928309|NCT01332149|147385678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0527|TWO_SIDED|95.0|-0.47|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.47|0.0527
73928310|NCT01332149|147385678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.121||0.0279|TWO_SIDED|95.0|-0.5|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.03|-0.50|0.0279
73928311|NCT01332149|147385678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.121||0.0508|TWO_SIDED|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.48|0.0508
73928312|NCT01332149|147385678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.121||0.0349|TWO_SIDED|95.0|-0.49|-0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.02|-0.49|0.0349
73928313|NCT01332149|147385678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.122||0.0672|TWO_SIDED|95.0|-0.46|0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.02|-0.46|0.0672
73928314|NCT01332149|147385678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.122||0.0469|TWO_SIDED|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.00|-0.48|0.0469
73928315|NCT01332149|147385678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.122||0.028|TWO_SIDED|95.0|-0.51|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.03|-0.51|0.0280
73928316|NCT01332149|147385678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.122||0.014|TWO_SIDED|95.0|-0.54|-0.06||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.06|-0.54|0.0140
73928317|NCT01332149|147385678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.122||0.0375|TWO_SIDED|95.0|-0.49|-0.01||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.01|-0.49|0.0375
73928318|NCT01332149|147385678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.105||0.0164|TWO_SIDED|95.0|-0.46|-0.05||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis||Overall change was estimated from the mixed effect model treatment main effect.|Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.46|0.0164
73928319|NCT01332149|147385680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.143||0.134|TWO_SIDED|95.0|-0.49|0.07||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.07|-0.49|0.1340
73928320|NCT01332149|147385681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.127||0.3438|TWO_SIDED|95.0|-0.37|0.13||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.13|-0.37|0.3438
73969979|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||8.5|-7.9|
73969980|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||7.9|-8.1|
74088043|NCT02709486|147729970|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.08|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.08|<.0001
73928321|NCT01332149|147385681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.128||0.2482|TWO_SIDED|95.0|-0.4|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.10|-0.40|0.2482
73928322|NCT01332149|147385681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.129||0.2249|TWO_SIDED|95.0|-0.41|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.10|-0.41|0.2249
73969981|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||8.5|-8.1|
73928323|NCT01332149|147385681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.129||0.1094|TWO_SIDED|95.0|-0.46|0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.05|-0.46|0.1094
73969982|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||8.5|-7.9|
73969983|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||7.9|-8.1|
73969984|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 3||8.5|-8.1|
73969985|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||"Difference = % V114-IM minus % PCV13~-SC. The 95% CI is based on the Miettinen and Nurminen method."|Poliovirus Type 3||8.5|-7.9|
73969986|NCT03848065|147479638|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 3||7.9|-8.1|
73969987|NCT03865498|147479670|SUPERIORITY||Odds Ratio (OR)|7.029|||<|0.0001|TWO_SIDED|95.0|4.919|10.323||McNemar's Chi-squared test (paired) with continuity correction to the test slightly more conservative|McNemar|||Hypothesis: There will be significant pre/post-intervention differences in isolated macro-level network structures for African American dementia caregiver networks.||10.323|4.919|< 0.0001
73969988|NCT03865498|147479670|SUPERIORITY||Odds Ratio (OR)|17.385|||<|0.0001|TWO_SIDED|95.0|9.963|33.157||McNemar's Chi-squared test (paired) with continuity correction to the test slightly more conservative|McNemar|||Hypothesis: There will be significant pre/post-intervention differences in isolated macro-level network structures for Hispanic dementia caregiver networks.||33.157|9.963|<0.0001
73969989|NCT03865498|147479670|SUPERIORITY||Odds Ratio (OR)|1.021||||0.924|TWO_SIDED|95.0|0.787|1.325||Pearson's Chi-squared test with Yates' continuity correction|Chi-squared, Corrected|||There will be no significant differences in isolated macro-level network structure from Tweets between Hispanic and African American dementia caregiver networks.||1.325|0.787|0.924
73969990|NCT03865498|147479671|SUPERIORITY|Pre-post mean difference|Mean Difference (Final Values)|0.628|||<|0.0001|TWO_SIDED|95.0|0.513|0.742|||a paired t-test|||Hypothesis: There will be significant pre/post-intervention differences in emotional valence score detected from Tweets for African American dementia caregiver networks.||0.742|0.513|<0.0001
73969991|NCT03865498|147479671|SUPERIORITY|Pre-post mean difference|Mean Difference (Final Values)|1.41|||<|0.0001|TWO_SIDED|95.0|1.189|1.631|||a paired t-test|||Hypothesis: There will be significant pre/post-intervention differences in emotional valence score detected from Tweets for Hispanic dementia caregiver networks.||1.631|1.189|<0.0001
73969992|NCT03865498|147479671|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.6|TWO_SIDED|95.0|-0.186|0.107|||t-test, 2 sided|||There will be no significant differences in emotional valence score detected from Tweets between Hispanic and African American dementia caregiver networks.||0.107|-0.186|0.600
73969993|NCT03852472|147479806|OTHER||% Difference (Avacopan - Placebo)|-8.4||||0.1321|TWO_SIDED|95.0|-18.7|2.4||P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment).|Cochran-Mantel-Haenszel|||||2.4|-18.7|0.1321
73969994|NCT03852472|147479806|OTHER||% Difference (Avacopan - Placebo)|4.3||||0.4503|TWO_SIDED|95.0|-6.9|15.5||P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment)|Cochran-Mantel-Haenszel|||||15.5|-6.9|0.4503
73969995|NCT03852472|147479807|OTHER||Least Squares Mean|0.6|STANDARD_ERROR_OF_MEAN|1.17||0.5784|TWO_SIDED|95.0|-1.7|2.9|||Mixed model for repeated measures|||||2.9|-1.7|0.5784
73862712|NCT00385723|147271307|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.8|TWO_SIDED|95.0|-0.64|0.18||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||0.18|-0.64|0.80
73928324|NCT01332149|147385681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.129||0.2095|TWO_SIDED|95.0|-0.41|0.09||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.09|-0.41|0.2095
73928325|NCT01332149|147385681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.129||0.0531|TWO_SIDED|95.0|-0.5|0.0||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.50|0.0531
73928326|NCT01332149|147385681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1628|TWO_SIDED|95.0|-0.44|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.07|-0.44|0.1628
73928327|NCT01332149|147385681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.077|TWO_SIDED|95.0|-0.48|0.02||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.02|-0.48|0.0770
73928328|NCT01332149|147385681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1651|TWO_SIDED|95.0|-0.43|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.07|-0.43|0.1651
73928329|NCT01332149|147385681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.1006|TWO_SIDED|95.0|-0.4|0.04||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.04|-0.40|0.1006
74088044|NCT02709486|147729970|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.07|<.0001
73928330|NCT01332149|147385682|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.1309|TWO_SIDED|95.0|0.93|1.74||Analysis was two-sided and performed at the 0.05 significance level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.||||1.74|0.93|0.1309
73928331|NCT01332149|147385685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.25|STANDARD_ERROR_OF_MEAN|1.628||0.0463|TWO_SIDED|95.0|-6.45|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||-0.05|-6.45|0.0463
73928332|NCT01332149|147385686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.061||0.2748|TWO_SIDED|95.0|-0.19|0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.05|-0.19|0.2748
73928333|NCT01332149|147385688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|1.577||0.4758|TWO_SIDED|95.0|-4.22|1.97||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||1.97|-4.22|0.4758
73928334|NCT01332149|147385689|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.31|STANDARD_ERROR_OF_MEAN|2.22||0.1363|TWO_SIDED|95.0|-1.05|7.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||7.67|-1.05|0.1363
73928335|NCT01332149|147385690|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|1.371||0.8808|TWO_SIDED|95.0|-2.49|2.9||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||2.90|-2.49|0.8808
73928336|NCT01332149|147385691|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.11||0.0887|TWO_SIDED|95.0|-0.03|0.4||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.40|-0.03|0.0887
73969996|NCT03852472|147479807|OTHER||Least Squares Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.17||0.2253|TWO_SIDED|95.0|-3.7|0.9|||Mixed effects model for repeated measure|||||0.9|-3.7|0.2253
73862713|NCT00385723|147271307|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.2|STANDARD_ERROR_OF_MEAN|0.21||1|TWO_SIDED|95.0|-0.61|0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||0.21|-0.61|1.0
73969997|NCT03161028|147479831|SUPERIORITY|||||||0.51||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||For the model evaluating the primary outcome (change in T25FW), T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). Any participants who were unable to complete the T25FW at any timepoint after baseline were assigned a value of 199 seconds, a statistical technique known as Winsorizing.||||0.51
73969998|NCT03161028|147479832|SUPERIORITY|||||||0.902|||||||Mixed Models Analysis|||||||0.902
73969999|NCT03161028|147479833|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.90
73970000|NCT03161028|147479834|SUPERIORITY|||||||0.084|||||||Mixed Models Analysis|||||||0.084
73970001|NCT03161028|147479835|SUPERIORITY|||||||0.134|||||||Chi-squared|||||||0.134
73928337|NCT01332149|147385692|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.7929|TWO_SIDED|95.0|0.72|1.53||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.||1.53|0.72|0.7929
73928338|NCT01332149|147385693|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.973||0.596|TWO_SIDED|95.0|-2.83|4.92||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||4.92|-2.83|0.5960
73928339|NCT01332149|147385694|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|1.536||0.8216|TWO_SIDED|95.0|-3.36|2.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||2.67|-3.36|0.8216
73928340|NCT01332149|147385695|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.177||0.4829|TWO_SIDED|95.0|-3.14|1.49||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||1.49|-3.14|0.4829
73928341|NCT01332149|147385696|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.073||0.0431|TWO_SIDED|95.0|-0.29|0.0||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.||-0.00|-0.29|0.0431
73928342|NCT01332149|147385697|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.074||0.0602|TWO_SIDED|95.0|-0.28|0.01||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.||0.01|-0.28|0.0602
73970005|NCT04828005|147479920|NON_INFERIORITY|Alternative hypothesis: Nalmefene reversal not less than 80% naloxone reversal|||||<|0.0009|||||||Mixed Models Analysis|||||||<0.0009
73970006|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.998|TWO_SIDED|95.0|-17.81|17.86|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||17.86|-17.81|0.998
73970007|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.445|TWO_SIDED|95.0|-24.73|10.93||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||10.93|-24.73|0.445
73970008|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|2.51||||0.781|TWO_SIDED|95.0|-15.33|20.36||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||20.36|-15.33|0.781
73970009|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|-3.09||||0.732|TWO_SIDED|95.0|-20.93|14.75||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||14.75|-20.93|0.732
73970010|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.212|TWO_SIDED|95.0|-6.53|29.14||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||29.14|-6.53|0.212
73970011|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|-6.44||||0.476|TWO_SIDED|95.0|-24.27|11.39|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||11.39|-24.27|0.476
73970012|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.962|TWO_SIDED|95.0|-17.4|18.26|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||18.26|-17.40|0.962
73970013|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.211|TWO_SIDED|95.0|-6.96|31.16|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||31.16|-6.96|0.211
73970014|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|2.67||||0.782|TWO_SIDED|95.0|-16.4|21.73|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||21.73|-16.40|0.782
74029424|NCT01522651|147613381|OTHER|Pairwise Comparative analysis||||||0.028||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.028
74088045|NCT02709486|147729970|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.92|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.32|-0.92|<.0001
73862714|NCT01299571|147271316|SUPERIORITY_OR_OTHER||Percentage of participants|3.8||||||95.0|3.2|4.4|||||The estimated value represents the percentage of participants with adverse events.|||4.4|3.2|
73862715|NCT01189292|147271319|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.0||||0.001|TWO_SIDED|95.0|12.0|42.0|||Chi-squared|||null hypothesis: Incidence of PONV is the same in both treatment arms||42|12|0.001
73928343|NCT01332149|147385699|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.207||0.4172|TWO_SIDED|95.0|-0.57|0.24||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.24|-0.57|0.4172
73928344|NCT01332149|147385700|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3724|TWO_SIDED|95.0|-0.62|0.23||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.23|-0.62|0.3724
73928345|NCT01920932|147385711|SUPERIORITY||Binomial proportions|31.25|||||TWO_SIDED|90.0||||The comparison of the complete rate between the first 32 evaluable participants and the historical control of HOD99 unfavorable risk patients was estimated by the binomial proportions test.||||In the historical control (HOD99) 17% of patients had CR at week 8. Sample size for this objective is calculated based on a binomial distribution to test H0: p=17% vs. Ha: p\>17%, where p is the true CR rate after 2 cycles of AEPA. 32 patients are needed to detect 20% increase of CR rate with 80% power and 5% type I error. If it shows efficacy, the response results will be reported, and the study will continue to enroll for a total of 77 patients to assess response and EFS.||||
73928346|NCT01920932|147385713|SUPERIORITY|||||||0.004|||||||Fisher Exact|||Comparison of proportion of patient's complete response rate between HLHR13 and HOD99 (NCT00145600) unfavorable risk arm 2 (UR2).||||0.004
73928347|NCT01920932|147385714|SUPERIORITY|||||||0.0008|||||||Log Rank|||The comparison of the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2) was done by the two-sample log-rank test.||||0.0008
73970015|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|14.72||||0.129|TWO_SIDED|95.0|-4.34|33.78|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||33.78|-4.34|0.129
73970016|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|13.27||||0.171|TWO_SIDED|95.0|-5.8|32.35|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||32.35|-5.80|0.171
74029425|NCT01522651|147613381|OTHER|Pairwise Comparative analysis||||||0.334||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.334
74029426|NCT02658656|147613384|SUPERIORITY||Risk Ratio (RR)|0.91||||0.798|TWO_SIDED|95.0|0.45|1.85|||Chi-squared|||||1.85|.45|0.798
73928348|NCT01920932|147385719|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
73928349|NCT01920932|147385719|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.002
74029427|NCT02658656|147613385|SUPERIORITY||Risk Ratio (RR)|0.97||||0.935|TWO_SIDED|95.0|0.44|2.15|||Chi-squared|||||2.15|0.44|0.935
74029428|NCT02658656|147613386|SUPERIORITY||Risk Ratio (RR)|0.93||||0.829|TWO_SIDED|95.0|0.49|1.79|||Chi-squared|||||1.79|0.49|0.829
73928350|NCT01920932|147385719|SUPERIORITY|||||||0.067|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T4, completion of radiation (approximately 8 months)||||0.067
74029429|NCT02658656|147613387|SUPERIORITY||Risk Ratio (RR)|1.09||||0.809|TWO_SIDED|95.0|0.56|2.11|||Chi-squared|||||2.11|0.56|0.809
73862716|NCT01189292|147271320|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.0||||0.006|TWO_SIDED|95.0|7.0|40.0|||Chi-squared|||per protocol analysis||40|7|0.006
73928351|NCT01920932|147385719|SUPERIORITY|||||||0.115|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.115
73928352|NCT01920932|147385719|SUPERIORITY|||||||0.455|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.455
73928353|NCT01920932|147385719|SUPERIORITY|||||||0.636|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T4, completion of radiation (approximately 8 months)||||0.636
73928354|NCT01920932|147385719|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
73970017|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|15.56||||0.108|TWO_SIDED|95.0|-3.49|34.62|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||34.62|-3.49|0.108
73970018|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|4.24||||0.661|TWO_SIDED|95.0|-14.83|23.3|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||23.30|-14.83|0.661
74029430|NCT02658656|147613388|SUPERIORITY||Risk Ratio (RR)|1.15||||0.717|TWO_SIDED|95.0|0.54|2.47|||Chi-squared|||||2.47|0.54|0.717
73928355|NCT01920932|147385719|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||<.001
73928356|NCT01920932|147385719|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T4, completion of radiation (approximately 8 months)||||0.006
73928357|NCT01920932|147385719|SUPERIORITY|||||||0.099|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.099
73928358|NCT01920932|147385719|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.050
73928359|NCT01920932|147385719|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T4, completion of radiation (approximately 8 months)||||0.520
73928360|NCT01920932|147385719|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.024
73928361|NCT01920932|147385719|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.011
73970019|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|14.21||||0.142|TWO_SIDED|95.0|-4.85|33.27|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||33.27|-4.85|0.142
73970020|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|11.98||||0.216|TWO_SIDED|95.0|-7.08|31.04|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||31.04|-7.08|0.216
73970021|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|7.38||||0.445|TWO_SIDED|95.0|-11.71|26.48|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||26.48|-11.71|0.445
74029431|NCT02658656|147613389|SUPERIORITY||Risk Ratio (RR)|1.11||||0.738|TWO_SIDED|95.0|0.61|2.02|||Chi-squared|||||2.02|0.61|0.738
73928362|NCT01920932|147385719|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T4, completion of radiation (approximately 8 months)||||0.009
73928363|NCT01920932|147385719|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
73928364|NCT01920932|147385719|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||<.001
73928365|NCT01920932|147385719|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T4, completion of radiation (approximately 8 months)||||0.035
73928366|NCT01920932|147385719|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.037
73928367|NCT01920932|147385719|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.043
73928368|NCT01920932|147385719|SUPERIORITY|||||||0.044|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T4, completion of radiation (approximately 8 months)||||0.044
73928369|NCT01920932|147385719|SUPERIORITY|||||||0.091|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.091
73928370|NCT01920932|147385719|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.248
73928371|NCT01920932|147385719|SUPERIORITY|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T4, completion of radiation (approximately 8 months)||||0.069
73928372|NCT01920932|147385719|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.010
73928373|NCT01920932|147385719|SUPERIORITY|||||||0.292|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.292
73928374|NCT01920932|147385719|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T4, completion of radiation (approximately 8 months)||||0.429
73928375|NCT01920932|147385720|SUPERIORITY|||||||0.975|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T1, At Diagnosis (baseline)||||0.975
73928376|NCT01920932|147385720|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||PedsQL v.4.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.032
73928377|NCT01920932|147385720|SUPERIORITY|||||||0.497|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.497
73928378|NCT01920932|147385720|SUPERIORITY|||||||0.399|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T4, completion of radiation (approximately 8 months)||||0.399
73928379|NCT01920932|147385720|SUPERIORITY|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T1, At Diagnosis (baseline)||||0.451
73970022|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|16.13||||0.096|TWO_SIDED|95.0|-2.92|35.19|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||35.19|-2.92|0.096
73970023|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|11.89||||0.22|TWO_SIDED|95.0|-7.19|30.96|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||30.96|-7.19|0.220
73970024|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|12.71||||0.189|TWO_SIDED|95.0|-6.35|31.78|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||31.78|-6.35|0.189
73970025|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|-2.67||||0.782|TWO_SIDED|95.0|-21.75|16.41|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||16.41|-21.75|0.782
73970026|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.528|TWO_SIDED|95.0|-12.98|25.18|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||25.18|-12.98|0.528
73970027|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|2.34||||0.795|TWO_SIDED|95.0|-15.45|20.12|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||20.12|-15.45|0.795
73970028|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|-6.13||||0.497|TWO_SIDED|95.0|-23.96|11.69|||mean difference|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||11.69|-23.96|0.497
73970029|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|7.44||||0.409|TWO_SIDED|95.0|-10.34|25.21|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.21|-10.34|0.409
73970030|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|7.89||||0.382|TWO_SIDED|95.0|-9.92|25.7|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.70|-9.92|0.382
73970031|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|7.74||||0.39|TWO_SIDED|95.0|-10.05|25.54|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.54|-10.05|0.390
73970032|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|-3.72||||0.68|TWO_SIDED|95.0|-21.54|14.1|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||14.10|-21.54|0.680
73970033|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.927|TWO_SIDED|95.0|-16.99|18.65|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||18.65|-16.99|0.927
73970034|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|6.02||||0.508|TWO_SIDED|95.0|-11.95|23.98||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 120 minutes post injection||23.98|-11.95|0.508
73970035|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|-3.65||||0.688|TWO_SIDED|95.0|-21.66|14.35|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||14.35|-21.66|0.688
73970036|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|16.08||||0.079|TWO_SIDED|95.0|-1.88|34.03|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||34.03|-1.88|0.079
73970037|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.323|TWO_SIDED|95.0|-8.96|26.96|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||26.96|-8.96|0.323
73970038|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|11.23||||0.183|TWO_SIDED|95.0|-5.39|27.85|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||27.85|-5.39|0.183
73970039|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|-2.61||||0.756|TWO_SIDED|95.0|-19.24|14.02|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||14.02|-19.24|0.756
73928380|NCT01920932|147385720|SUPERIORITY|||||||0.198|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.198
73928381|NCT01920932|147385720|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.967
73928382|NCT01920932|147385720|SUPERIORITY|||||||0.647|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T4, completion of radiation (approximately 8 months)||||0.647
73928383|NCT01920932|147385720|SUPERIORITY|||||||0.145|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T1, At Diagnosis (baseline)||||0.145
73928384|NCT01920932|147385720|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
73970040|NCT04802967|147479948|SUPERIORITY||Mean Difference (Final Values)|3.96||||0.638|TWO_SIDED|95.0|-12.68|20.59|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||20.59|-12.68|0.638
73970041|NCT01824875|147479977|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.46|1.07|||||Hazard ratio of Arm B/Arm A|||1.07|0.46|
73970042|NCT01824875|147479978|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
73928385|NCT01920932|147385720|SUPERIORITY|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.073
73928386|NCT01920932|147385720|SUPERIORITY|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T4, completion of radiation (approximately 8 months)||||0.156
73928387|NCT01920932|147385720|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T1, At Diagnosis (baseline)||||0.844
73928388|NCT01920932|147385720|SUPERIORITY|||||||0.206|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.206
73928389|NCT01920932|147385720|SUPERIORITY|||||||0.491|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.491
73862717|NCT01189292|147271323|SUPERIORITY_OR_OTHER|||||||0.674|TWO_SIDED||||||Mixed Models Analysis|mixed model over the mean ranks at all time points measured (4, 8, 16, 24, 32, 48 hours)||||||0.674
73928390|NCT01920932|147385720|SUPERIORITY|||||||0.906|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T4, completion of radiation (approximately 8 months)||||0.906
73928391|NCT01920932|147385720|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T1, At Diagnosis (baseline)||||0.580
73928392|NCT01920932|147385720|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.012
73928393|NCT01920932|147385720|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.010
74029432|NCT02026908|147613414|OTHER|Paired T- test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated with threshold of significance \<0.05.|t-test, 2 sided||A p-value was calculated. Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|||||0.0001
73928394|NCT01920932|147385720|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T4, completion of radiation (approximately 8 months)||||0.005
73928395|NCT03240575|147385743|SUPERIORITY||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.027||0.0543|TWO_SIDED|95.0|-0.001|0.105|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.105|-0.001|0.0543
73928396|NCT03240575|147385744|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.027||0.0011|TWO_SIDED|95.0|0.037|0.144|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.144|0.037|0.0011
73928397|NCT03240575|147385745|SUPERIORITY||Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.027||0.8593|TWO_SIDED|95.0|-0.048|0.058|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.058|-0.048|0.8593
73928398|NCT03240575|147385746|SUPERIORITY||Mean Difference (Net)|0.098|STANDARD_ERROR_OF_MEAN|0.029||0.001|TWO_SIDED|95.0|0.04|0.156|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.156|0.040|0.0010
73928399|NCT00913744|147385821|SUPERIORITY_OR_OTHER||Difference in proportions|12.3||||0.262|TWO_SIDED|95.0|-3.7|28.4|||Fisher Exact|P-value is from Fisher's exact test, comparing sham and ocriplasmin.||||28.4|-3.7|0.262
73928400|NCT00357370|147385847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1898|||TWO_SIDED|95.0|-1.08|-0.32|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-0.32|-1.08|
73928401|NCT00357370|147385847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.1903|||TWO_SIDED|95.0|-1.16|-0.4|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-0.40|-1.16|
73928402|NCT00357370|147385848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.44|STANDARD_ERROR_OF_MEAN|11.4753|||TWO_SIDED|95.0|-38.37|7.48|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||7.48|-38.37|
73928403|NCT00357370|147385848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.44|STANDARD_ERROR_OF_MEAN|11.4574|||TWO_SIDED|95.0|-50.33|-4.55|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-4.55|-50.33|
74029433|NCT02026908|147613415|OTHER|Paired t test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.0001
74029434|NCT02026908|147613416|OTHER|Paired T test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.0001
74029435|NCT02026908|147613417|OTHER|Paired T Test|p value|0.05||||0.0001|TWO_SIDED|||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided|||||||0.0001
73928404|NCT00357370|147385852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|3.8302|||TWO_SIDED|95.0|-10.69|4.6|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||4.60|-10.69|
73928405|NCT00357370|147385852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52|STANDARD_ERROR_OF_MEAN|3.8291|||TWO_SIDED|95.0|-10.17|5.12|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||5.12|-10.17|
73928406|NCT00404352|147385889|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||<0.001
73928407|NCT00404352|147385889|SUPERIORITY_OR_OTHER|||||||0.008|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.008
73928408|NCT00404352|147385889|SUPERIORITY_OR_OTHER|||||||0.009|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.009
73928409|NCT00404352|147385890|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||<0.001
73928410|NCT00404352|147385890|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.002
73928411|NCT00404352|147385890|SUPERIORITY_OR_OTHER|||||||0.774|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.774
73928412|NCT01417481|147385923|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||>0.05
73928413|NCT01417481|147385924|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||>0.05
73928414|NCT01417481|147385925|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||>0.05
73928415|NCT01417481|147385926|SUPERIORITY_OR_OTHER||||||=|0.061|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.061
73928416|NCT01417481|147385927|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.068
73928417|NCT01417481|147385928|SUPERIORITY_OR_OTHER||||||=|0.04|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.040
73928418|NCT01417481|147385929|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||<0.05
73928419|NCT01417481|147385930|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, paired analysis was done. The hypothesis was that glycine will improve variables, thus significance was set at one-tail.||||||<0.05
73928420|NCT01417481|147385931|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||<0.01
73928421|NCT01417481|147385932|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||>0.05
73928422|NCT04630093|147385941|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline vs. 6 months after receiving panel-based pharmacogenetic testing||||0.001
73928423|NCT04296396|147385945|NON_INFERIORITY|A non-inferiority design assumed a noninferiority margin of 5%. For 90% power and 0.025 significance level 1-sided, a total sample size of 4,300 participants was required to state that the IOPP is not inferior to the fixed amount of 20 tablets. Given the short window to assess pain at 1-week post-discharge, a 20% missing rate was incorporated which gives a final sample size of 5,500 (2,750 per group).|Risk Difference (RD)|0.67|||||TWO_SIDED|95.0|-2.03|3.37|||||The risk difference is the rate in the fixed group minus the rate in the IOPP group. IOPP was to be determined as non-inferior if the lower 95% confidence limit for the risk difference is -5 percentage points or greater (i.e., closer to zero).|||3.37|-2.03|
73928424|NCT04296396|147385946|SUPERIORITY||Risk Ratio (RR)|1.22||||0.046|TWO_SIDED|96.25|0.99|1.51|||Chi-squared||Confidence interval is 96.25% due to false discovery rate adjustment|||1.51|0.99|0.046
73928425|NCT04296396|147385947|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73928426|NCT04296396|147385948|SUPERIORITY||Median Difference (Net)|-5.0|||<|0.001|TWO_SIDED|97.5|-6.6|-3.5|||quantile regression||Confidence interval is 97.5% due to false discovery rate adjustment|||-3.5|-6.6|<0.001
73928427|NCT04296396|147385949|SUPERIORITY||Median Difference (Net)|-15.0|||<|0.001|TWO_SIDED|98.75|-19.2|-10.8|||quartile regression||Confidence interval is 98.75% due to false discovery rate adjustment|||-10.8|-19.2|<0.001
73970043|NCT01098812|147479984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.0|STANDARD_DEVIATION|75.0|<|0.0001|ONE_SIDED|90.0|25.0|||Primary study endpoint; therefore, no adjustment for multiple comparisons. The planned alpha level for testing was 0.025.|t-test, 1 sided|||Toric IOL results for mean percent reduction in cyl compared to control results at 6 months. Null hypothesis = mean reduction for toric eyes is \<= to that of control eyes; alternate hypothesis = mean reduction for toric eyes is \> the control. There is 80% power to detect \>=31% difference in mean percent reduction in cylinder (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder) between IOL groups.|||25|<0.0001
73970044|NCT01098812|147479985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.15||0.0009|ONE_SIDED|90.0||-0.03||P-value compared to alpha level adjusted for multiplicity of 0.0125.|t-test, 1 sided|||Used LogMAR values for visual acuity; The null hypothesis is that the mean UCDVA for toric eyes is worse than or equal to that for control eyes; the alternate hypothesis is that the mean UCDVA for toric eyes is better than that for control eyes. There is 80% power to detect \>=0.06 LogMAR difference in mean UCDVA between IOL groups.||-0.03||0.0009
73862718|NCT01189292|147271324|SUPERIORITY_OR_OTHER|||||||0.835|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.835
73928428|NCT04296396|147385950|SUPERIORITY||Median Difference (Net)|0.0||||1|TWO_SIDED|95.0|0.0|0.0|||quantile regression|||||0|0|1.0
73928429|NCT04296396|147385951|SUPERIORITY||Risk Ratio (RR)|0.96||||0.52|TWO_SIDED|95.0|0.85|1.09|||Chi-squared|||||1.09|0.85|0.52
73928430|NCT04296396|147385952|SUPERIORITY||Risk Ratio (RR)|0.99||||0.15|TWO_SIDED|95.0|0.98|1.0|||Regression, Linear|||||1.00|0.98|0.15
73928431|NCT01077960|147385955|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73928432|NCT01077960|147385956|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73928433|NCT01077960|147385957|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73928434|NCT01077960|147385958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73928435|NCT01077960|147385959|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
73928436|NCT01077960|147385960|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
73928437|NCT01465464|147386016|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.435|TWO_SIDED|95.0|0.878|1.352|||Log Rank|||||1.352|0.878|0.435
73928438|NCT01554618|147386018|SUPERIORITY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.33||0.012|TWO_SIDED|95.0|-1.51|-0.19|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline HbA1c value (continuous) and baseline HbA1c by visit interaction as fixed effects, using an unstructured covariance matrix.||-0.19|-1.51|0.012
73970045|NCT05337306|147480125|SUPERIORITY|ANCOVA controlling for study arm and baseline||||||0.049||||||a priori threshold .05; no adjustment for multiple comparisons|ANCOVA|covariates include arm and baseline level of outcome||Last Observation Carried Forward (LOCF) for those lost to follow up; null hypothesis group 1 follow-up outcome = group 2 follow-up outcome.||||.049
73970046|NCT05337306|147480126|SUPERIORITY|||||||0.04||||||a priori threshold .05; no adjustment for multiple comparisons|ANCOVA|Covariates include trial arm and baseline level of outcome.||LOCF for lost to follow-up||||.040
73970047|NCT05337306|147480127|SUPERIORITY|||||||0.22|||||||ANCOVA|covariates include trial arm and baseline level of outcome.||LOCF for dropout/lost to follow up||||.220
73970048|NCT02310646|147480245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Treatment sequence effect: p=0.28; gender effect: p=0.20; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and gender as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: gender (male, female)."||||0.2
73970049|NCT02310646|147480245|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.001||||||Treatment sequence effect: p=0.34; age effect: p=0.001; threshold for statistical significance: p\<0.05.|Regression, Logistic|2-factor logistic regression with age and treatment sequence as factors||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: age (18-39 years, 40-59 years, ≥60 years)."||||=0.001
73970050|NCT02310646|147480245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||Treatment sequence effect: p=0.34; baseline disease severity effect: p=0.29; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and baseline disease severity as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: Baseline disease severity (mild, moderate, severe)."||||0.29
73970051|NCT02310646|147480245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||Treatment sequence effect: p=0.33; distribution phenotype (localised, widespread) effect: p=0.55; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and distribution phenotype (localised, widespread) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: distribution phenotype (localised, widespread)."||||0.55
73970052|NCT02310646|147480245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||||||Treatment sequence effect: p=0.32; plaque size (≤3 mm diameter, \>3 mm diameter): p=0.25; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and plaque size as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: plaque size (≤3 mm diameter, \>3 mm diameter)."||||0.25
73970053|NCT02310646|147480245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||||||Treatment sequence effect: p=0.34; skin thickness phenotype (≤0.75 mm, \>0.75 mm) effect: p=0.41; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and skin thickness phenotype as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: skin thickness phenotype (≤0.75 mm, \>0.75 mm)."||||0.41
73970054|NCT02310646|147480245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Treatment sequence effect: p=0.30; onset phenotype (≤40 years of age, \>40 years of age) effect: p=0.20; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and onset phenotype (≤40 years of age, \>40 years of age) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: onset phenotype (≤40 years of age, \>40 years of age)."||||0.20
73970055|NCT02310646|147480246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||"The total TPUQ score for the gel and the foam (mean score 29.9 vs. mean score 26.8; p=0.007).~Threshold for statistical significance: p\<0.05."|Wilcoxon Rank Sum Test|Wilcoxon rank sum test comparing the period difference (within subject difference between study treatments) between both treatment sequences.||Subjects in the analysis are 212 - full analysis set. All subjects received both study treatments. Total TPUQ score (summary score item 1-25) superiority comparison gel versus foam.||||0.007
73970056|NCT02310646|147480247|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison foam versus latest topical treatment.||||<0.001
73970057|NCT02310646|147480247|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison gel versus latest topical treatment.||||<0.001
73970058|NCT04137367|147480259|OTHER|||||||0.05|||||||Mixed Models Analysis|||We estimated a priori that a total of 100 participants would be needed to detect a difference between ABM and sham condition, with a two-tailed α of 0.05 and (1-β) of .80. Power calculation was based on the assumption that 50 % of the participants allocated to ABM would report a minimum of 3 points reduction on BDI-II at six months, compared to 20 % in the sham condition. Assuming 15 % lost to follow up, power calculation indicated the need for 50 participants in each condition||||.05
73970059|NCT02547363|147480298|SUPERIORITY||||||<|0.001|||||||Fisher exact test|||||||<0.001
73862719|NCT00316888|147271346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218|||||||one sample binomial test|||Null hypothesis is that the local failure rate at 3 years is no more than 35%.||||0.218
73928439|NCT01554618|147386021|SUPERIORITY||LS Mean Difference|-21.6|STANDARD_ERROR_OF_MEAN|13.7||0.119|TWO_SIDED|95.0|-49.0|5.7|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline fasting plasma glucose value, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline fasting plasma glucose by visit interaction as fixed effects, using an unstructured covariance matrix.||5.7|-49.0|0.119
73928440|NCT01554618|147386022|SUPERIORITY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|1.189||0.307|TWO_SIDED|95.0|-3.59|1.15|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline body weight, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline body weight by visit interaction as fixed effects, using an unstructured covariance matrix.||1.15|-3.59|0.307
73928441|NCT01554618|147386023|SUPERIORITY||LS Mean Difference|94.9|STANDARD_ERROR_OF_MEAN|95.26||0.323|TWO_SIDED|95.0|-95.6|285.5|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline fasting insulin, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline fasting insulin by visit interaction as fixed effects, using an unstructured covariance matrix.||285.5|-95.6|0.323
73928442|NCT01554618|147386024|SUPERIORITY||Difference|14.8||||0.077|TWO_SIDED|95.0|1.9|27.7|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c \< 6.5%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||27.7|1.9|0.077
73928443|NCT01554618|147386024|SUPERIORITY||Difference|14.8||||0.077|TWO_SIDED|95.0|1.9|27.7|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c ≤ 6.5%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||27.7|1.9|0.077
73928444|NCT01554618|147386024|SUPERIORITY||Difference|22.7||||0.02|TWO_SIDED|95.0|6.5|39.0|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c \< 7.0%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||39.0|6.5|0.020
73928445|NCT01554618|147386026|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.61||0.284|TWO_SIDED|95.0|-8.0|2.4|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in SBP:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline SBP, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline SBP by visit interaction as fixed effects, using an unstructured covariance matrix."||2.4|-8.0|0.284
73928446|NCT01554618|147386026|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.77||0.376|TWO_SIDED|95.0|-2.0|5.1|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in DBP:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline DBP, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline DBP by visit interaction as fixed effects, using an unstructured covariance matrix."||5.1|-2.0|0.376
73928447|NCT01554618|147386028|SUPERIORITY||LS Mean Difference|90.37|STANDARD_ERROR_OF_MEAN|69.207||0.211|TWO_SIDED|95.0|-57.27|238.0|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in HOMA-B:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline HOMA-B, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline HOMA-B by visit interaction as fixed effects, using an unstructured covariance matrix."||238.00|-57.27|0.211
73928448|NCT01554618|147386028|SUPERIORITY||LS Mean Difference|-6.75|STANDARD_ERROR_OF_MEAN|6.173||0.289|TWO_SIDED|95.0|-19.8|6.29|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in HOMA-S:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline HOMA-S, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline HOMA-S by visit interaction as fixed effects, using an unstructured covariance matrix."||6.29|-19.80|0.289
73928449|NCT02244580|147386047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.423||||0.0018|TWO_SIDED|95.0|0.246|0.726|||Regression, Cox|||||0.726|0.246|0.0018
73928450|NCT02244580|147386048|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.001|TWO_SIDED|95.0|0.25|0.71|||Regression, Cox|||||0.71|0.25|0.001
73862720|NCT00316888|147271346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592|||||||one sample binomial test|||The null hypothesis is that the local failure rate at 3 years is no more than 35%.||||0.592
73928451|NCT01495585|147386054|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.||||0.03
73928452|NCT01495585|147386054|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.||||<0.0001
73928453|NCT01495585|147386055|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
73928454|NCT01495585|147386055|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
73862721|NCT00815191|147271355|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority delta of 0.5°C|Mean Difference (Final Values)|0.091|||<|0.0001|TWO_SIDED|95.0|-0.139|0.321|||ANOVA|Repeated measures ANOVA||||0.321|-0.139|<0.0001
73928455|NCT04448210|147386056|SUPERIORITY||||||<|0.25|||||||ANOVA|||||||<.25
73928456|NCT04448210|147386057|SUPERIORITY|||||||0.72|||||||ANOVA|||||||.72
73928457|NCT04448210|147386058|SUPERIORITY|||||||0.16|||||||ANOVA|||||||.16
73928458|NCT04448210|147386059|SUPERIORITY|||||||0.43|||||||ANOVA|||||||.43
73928459|NCT04448210|147386060|SUPERIORITY|||||||0.69|||||||ANOVA|||||||.69
73928460|NCT04448210|147386061|SUPERIORITY|||||||0.38|||||||ANOVA|||||||.38
73928461|NCT04448210|147386062|SUPERIORITY|||||||0.94|||||||ANOVA|||||||.94
73970060|NCT02547363|147480299|SUPERIORITY||Ratio of clearance rates|62.59|||<|0.001|TWO_SIDED|95.0|8.68|451.08|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||451.08|8.68|<0.001
73970061|NCT02547363|147480300|SUPERIORITY||Ratio of clearance rates|59.21|||<|0.001|TWO_SIDED|95.0|8.44|415.35|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||415.35|8.44|<0.001
73970062|NCT02547363|147480301|SUPERIORITY||Week 8 AK count ratio|0.27|||<|0.001|TWO_SIDED|95.0|0.23|0.32|||Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.32|0.23|<0.001
73970063|NCT05977530|147480385|SUPERIORITY||comparison of ranks in Wilcoxon|0.0|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.01
73970064|NCT04382664|147480386|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.845|TWO_SIDED|80.0|0.694|1.309|||Regression, Cox|||||1.309|0.694|0.845
73970065|NCT01733316|147480400|SUPERIORITY|||||||0.0048||||||Paired t-test testing the null hypothesis that the population average difference during the Cystagon® phase is equal to the population average difference during the RP103 phase.|Paired t-test, two-sided|||||||0.0048
73970066|NCT01674140|147480409|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.52|TWO_SIDED|95.0|0.77|1.14|||Log Rank|||||1.14|0.77|0.52
73970067|NCT01674140|147480410|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.84|TWO_SIDED|95.0|0.75|1.26|||Log Rank|||||1.26|0.75|0.84
73970068|NCT01674140|147480412|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.32|TWO_SIDED|95.0|0.74|1.1|||Log Rank|||||1.10|0.74|0.32
73970069|NCT05239455|147480418|OTHER|The FDA requires one-sided 95% lower confidence limit for the population proportion of success is greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75%. Allows for low recoveries (\<75%) in 2/20 or 3/24 volunteers.|95% Confidence Interval|88.5|||||ONE_SIDED|95.0|72.81||||||A one-sided confidence interval for the proportion of successes was determined using the Clopper-Pearson exact method for a 95% confidence interval.|The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.|Proportion of successes greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75% was calculated.||72.81|
73970070|NCT05239455|147480419|OTHER|The FDA criteria requires LR-RBC mean 24-hour recovery ≥ 75% with standard deviation (SD) ≤ 9%||||||||||||||||The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.|Mean and standard deviation were calculated.|||
73928462|NCT04448210|147386063|SUPERIORITY|||||||0.94|||||||ANOVA|||||||.94
73928463|NCT04448210|147386064|SUPERIORITY|||||||0.3|||||||ANOVA|||||||.30
73928464|NCT01399593|147386271|SUPERIORITY||Proportion difference|-3.9||||0.76|TWO_SIDED|95.0|-23.9|16.3|||Fisher Exact|||||16.3|-23.9|0.76
73970071|NCT03945292|147480488|SUPERIORITY||Difference|-66.81|STANDARD_ERROR_OF_MEAN|5.107|<|0.0001|TWO_SIDED|95.0|-77.18|-56.45||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|Mixed model repeated measures (MMRM)|NAFLD=non-alcoholic fatty liver disease; NSH=non-alcoholic steatohepatitis||||-56.45|-77.18|< 0.0001
73970072|NCT03945292|147480488|SUPERIORITY||Difference|-90.03|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-100.72|-79.34||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|MMRM|||||-79.34|-100.72|< 0.0001
73970073|NCT03945292|147480488|SUPERIORITY||Difference|-97.57|STANDARD_ERROR_OF_MEAN|5.24|<|0.0001|TWO_SIDED|95.0|-108.21|-86.94||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|MMRM|||||-86.94|-108.21|< 0.0001
73970074|NCT03945292|147480492|SUPERIORITY||Least Squares (LS) Mean Difference|-129.31|STANDARD_ERROR_OF_MEAN|36.409||0.0021|TWO_SIDED|95.0|-205.52|-53.11||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-53.11|-205.52|0.0021
73928465|NCT00249470|147386274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.8||||0.004|TWO_SIDED|95.0|2.03|16.56|||General Estimating Equation (GEE)|||||16.56|2.03|.004
73928466|NCT00249470|147386275|SUPERIORITY||Odds Ratio (OR)|0.91|||=|0.82|TWO_SIDED|95.0|0.4|2.08|||General Estimating Equation (GEE)|||||2.08|0.40|=0.82
73928467|NCT00249470|147386276|SUPERIORITY||Odds Ratio (OR)|3.37||||0.04|TWO_SIDED|95.0|1.21|9.37|||General Estimating Equation (GEE)|||||9.37|1.21|0.04
73928468|NCT00244712|147386277|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the ABC/3TC to the TDF/FTC would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 \[ABC/3TC minus TDF/FTC\] was -12% or greater.|difference in response percentage|0.39||||0.913||95.0|-6.63|7.4|||Cochran-Mantel-Haenszel||Difference in response percentage = percentage in Arm 1 minus percentage in Arm 2|||7.40|-6.63|0.913
73928469|NCT00500370|147386294|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||<0.0001
73928470|NCT00500370|147386295|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||<0.0001
73928471|NCT00500370|147386296|SUPERIORITY_OR_OTHER|||||||0.6766||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.6766
73928472|NCT00500370|147386297|SUPERIORITY_OR_OTHER|||||||0.0393||95.0|||||Cochran-Mantel-Haenszel|||||||0.0393
73928473|NCT00500370|147386298|SUPERIORITY_OR_OTHER|||||||0.1808||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1808
73928474|NCT00500370|147386299|SUPERIORITY_OR_OTHER|||||||0.1204||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1204
73970075|NCT03945292|147480492|SUPERIORITY||LS Mean Difference|-124.03|STANDARD_ERROR_OF_MEAN|37.207||0.0035|TWO_SIDED|95.0|-201.9|-46.15||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-46.15|-201.9|0.0035
73928475|NCT00500370|147386300|SUPERIORITY_OR_OTHER|||||||0.6651||95.0|||||ANCOVA|||||||0.6651
73928476|NCT00500370|147386301|SUPERIORITY_OR_OTHER|||||||0.1204||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1204
73928477|NCT00500370|147386302|SUPERIORITY_OR_OTHER|||||||0.8479||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.8479
73928478|NCT00500370|147386303|SUPERIORITY_OR_OTHER|||||||0.2151||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.2151
73928479|NCT00500370|147386304|SUPERIORITY_OR_OTHER|||||||0.7619||95.0|||||ANCOVA|||||||0.7619
73928480|NCT00500370|147386305|SUPERIORITY_OR_OTHER|||||||0.8973||95.0|||||ANCOVA|||||||0.8973
73928481|NCT00500370|147386306|SUPERIORITY_OR_OTHER|||||||0.6507||95.0|||||Cochran-Mantel-Haenszel|||||||0.6507
73928482|NCT00500370|147386307|SUPERIORITY_OR_OTHER|||||||0.2593||95.0|||||Cochran-Mantel-Haenszel|||||||0.2593
73928483|NCT00500370|147386308|SUPERIORITY_OR_OTHER|||||||0.2919||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.2919
73928484|NCT00500370|147386309|SUPERIORITY_OR_OTHER|||||||0.0293||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.0293
73928485|NCT05627518|147386323|OTHER||Ratio|1.9954|||<|0.0001|TWO_SIDED|95.0|1.8399|2.1641|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|The Ratio of geometric mean AUCinf comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.1641|1.8399|<0.0001
73928486|NCT05627518|147386323|OTHER||Ratio|2.125|||<|0.0001|TWO_SIDED|95.0|1.9664|2.2963|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|AUClast: Ratio of geometric mean AUClast comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.2963|1.9664|<0.0001
73928487|NCT05627518|147386324|OTHER|Ratio|Ratio|2.3167|||<|0.0001|TWO_SIDED|95.0|2.0922|2.5652|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|Ratio of geometric mean Cmax comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.5652|2.0922|<0.0001
73970076|NCT03945292|147480492|SUPERIORITY||LS Mean Difference|-140.58|STANDARD_ERROR_OF_MEAN|30.906||0.0002|TWO_SIDED|95.0|-205.27|-75.89||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-75.89|-205.27|0.0002
73970077|NCT03945292|147480494|SUPERIORITY||LS Mean Difference|-98.07|STANDARD_ERROR_OF_MEAN|20.291||0.0001|TWO_SIDED|95.0|-140.53|-55.6||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-55.6|-140.53|0.0001
73970078|NCT03945292|147480494|SUPERIORITY||LS Mean Difference|-109.56|STANDARD_ERROR_OF_MEAN|21.616|<|0.0001|TWO_SIDED|95.0|-154.81|-64.32||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-64.32|-154.81|< 0.0001
73970079|NCT03945292|147480494|SUPERIORITY||LS Mean Difference|-118.04|STANDARD_ERROR_OF_MEAN|17.16|<|0.0001|TWO_SIDED|95.0|-153.95|-82.12||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-82.12|-153.95|< 0.0001
73928488|NCT05627518|147386325|OTHER|Ratio|Ratio|0.757|||<|0.0001|TWO_SIDED|95.0|0.7009|0.8177|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUCinf comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.8177|0.7009|<0.0001
73928489|NCT05627518|147386325|OTHER|Ratio|Ratio|0.7684|||<|0.0001|TWO_SIDED|95.0|0.7102|0.8313|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUClast comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.8313|0.7102|<0.0001
73928490|NCT05627518|147386326|OTHER|Ratio|Ratio|0.2548|||<|0.0001|TWO_SIDED|95.0|0.1999|0.3247|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean Cmax comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.3247|0.1999|<0.0001
73928491|NCT05627518|147386327|OTHER|Ratio|Ratio|3.0245|||<|0.0001|TWO_SIDED|95.0|2.5098|3.6446|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean AUCinf comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||3.6446|2.5098|<0.0001
73928492|NCT05627518|147386327|OTHER|Ratio|Ratio|3.5277|||<|0.0001|TWO_SIDED|95.0|2.9076|4.2799|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean AUClast comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||4.2799|2.9076|<0.0001
74029436|NCT02026908|147613418|OTHER|Paired T test|p value|0.05||||0.008|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|||||0.008
74029437|NCT03504774|147613444|OTHER||Mean Difference (Net)|0.6||||0.3|TWO_SIDED||||||Mixed Models Analysis|||analysis of the change from baseline in CD28 expression||||0.30
74029438|NCT03504774|147613445|OTHER||Mean Difference (Net)|0.9||||0.82|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 52||||0.82
74029439|NCT03504774|147613445|OTHER||Mean Difference (Net)|1.2||||0.053|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis on the change from baseline to week 58||||0.053
73928493|NCT05627518|147386328|OTHER|Ratio|Ratio|3.0245|||<|0.0001|TWO_SIDED|95.0|2.5098|3.6446|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean Cmax comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||3.6446|2.5098|<0.0001
73928494|NCT05627518|147386329|OTHER|Ratio|Ratio|0.4923|||<|0.0001|TWO_SIDED|95.0|0.4131|0.5867|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUCinf comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.5867|0.4131|<0.0001
73928495|NCT05627518|147386329|OTHER|Ratio|Ratio|0.4923|||<|0.0001|TWO_SIDED|95.0|0.4047|0.5989|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUClast comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.5989|0.4047|<0.0001
73928496|NCT05627518|147386330|OTHER|Ratio|Ratio|0.2522|||<|0.0001|TWO_SIDED|95.0|0.198|0.3211|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean Cmax comparing test formulation fed (treatment C) vs. reference formulation fasted (treatment B). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.3211|0.1980|<0.0001
74029440|NCT03504774|147613445|OTHER||Mean Difference (Net)|0.3||||0.062|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from week 52 to week 58||||0.062
74029441|NCT03504774|147613445|OTHER||Mean Difference (Net)|0.2||||0.3|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 52||||0.30
73928497|NCT04041869|147386347|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||In order to test the effect of the intervention on physical activity, linear mixed models examined changes in steps per day from study baseline (week 0) to the end of the active intervention (week 8).||||<0.01
73928498|NCT02970968|147386368|SUPERIORITY|||||||0.0099|||||||Mixed Models Analysis|||||||.0099
73928499|NCT02970968|147386369|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|||||||.0160
73928500|NCT02970968|147386370|SUPERIORITY|||||||0.039|||||||Mixed Models Analysis|||||||.039
73928501|NCT02970968|147386371|SUPERIORITY|||||||0.0223|||||||Mixed Models Analysis|||||||.0223
73928502|NCT02970968|147386372|SUPERIORITY|||||||0.0497|||||||Mixed Models Analysis|||||||.0497
73928503|NCT02970968|147386373|SUPERIORITY|||||||0.0207|||||||Mixed Models Analysis|||||||.0207
73928504|NCT02970968|147386374|SUPERIORITY|||||||0.0429|||||||Mixed Models Analysis|||||||.0429
73928505|NCT02970968|147386375|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
73928506|NCT02970968|147386376|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||.0003
73928507|NCT02970968|147386377|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||||||.023
73928508|NCT02970968|147386378|SUPERIORITY|||||||0.0078|||||||Mixed Models Analysis|||||||.0078
73928509|NCT02970968|147386379|SUPERIORITY|||||||0.0294|||||||Mixed Models Analysis|||||||.0294
73928510|NCT02970968|147386380|SUPERIORITY|||||||0.0229|||||||Mixed Models Analysis|||||||.0229
73928511|NCT02970968|147386381|SUPERIORITY|||||||0.0018|||||||Mixed Models Analysis|||||||.0018
73928512|NCT02970968|147386382|SUPERIORITY|||||||0.0013|||||||Mixed Models Analysis|||||||.0013
73928513|NCT02970968|147386383|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||.0001
73928514|NCT02970968|147386384|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||.018
73928515|NCT02970968|147386385|SUPERIORITY|||||||0.0164|||||||Mixed Models Analysis|||||||.0164
73928516|NCT02970968|147386386|SUPERIORITY|||||||0.0053|||||||Mixed Models Analysis|||||||.0053
73928517|NCT02970968|147386387|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||.0020
73928518|NCT00071812|147386421|SUPERIORITY_OR_OTHER||percent difference from placebo|18.8||||0.0097|TWO_SIDED|95.0|4.8|32.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||32.8|4.8|0.0097
73928519|NCT00071812|147386421|SUPERIORITY_OR_OTHER||percent difference from placebo|9.4||||0.1677|TWO_SIDED|95.0|-3.9|22.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||22.7|-3.9|0.1677
73928520|NCT00071812|147386421|SUPERIORITY_OR_OTHER||percent difference from placebo|12.2||||0.0796|TWO_SIDED|95.0|-1.3|25.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||25.8|-1.3|0.0796
74029442|NCT03504774|147613445|OTHER||Mean Difference (Net)|1.0||||0.54|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 58||||0.54
74029443|NCT03504774|147613445|OTHER||Mean Difference (Net)|1.2||||0.82|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from week 52 to week 58||||0.82
74029444|NCT03504774|147613446|OTHER||Mean Difference (Net)|4.8||||0.25|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 52||||0.25
74029445|NCT03504774|147613446|OTHER||Mean Difference (Net)|10.8||||0.24|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 58||||0.24
73862722|NCT01291836|147271356|SUPERIORITY_OR_OTHER_LEGACY||Area under Receiver-Operator Curve (ROC)|0.658|||||TWO_SIDED|95.0|0.586|0.73||||||Null Hypothesis: ROC AUC of 0.58; using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|0.73|0.586|
73928521|NCT00071812|147386422|SUPERIORITY_OR_OTHER||percent difference from placebo|5.4||||0.2074|TWO_SIDED|95.0|-3.0|13.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||13.7|-3.0|0.2074
73928522|NCT00071812|147386422|SUPERIORITY_OR_OTHER||percent difference from placebo|4.1||||0.3177|TWO_SIDED|95.0|-4.0|12.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||12.2|-4.0|0.3177
73928523|NCT00071812|147386422|SUPERIORITY_OR_OTHER||percent difference from placebo|9.7||||0.0418|TWO_SIDED|95.0|0.3|19.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||19.2|0.3|0.0418
73928524|NCT00071812|147386423|SUPERIORITY_OR_OTHER||percent difference from placebo|2.7||||0.4299|TWO_SIDED|95.0|-4.0|9.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||9.3|-4.0|0.4299
73928525|NCT00071812|147386423|SUPERIORITY_OR_OTHER||percent difference from placebo|-1.5||||0.5393|TWO_SIDED|95.0|-6.3|3.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||3.3|-6.3|0.5393
73928526|NCT00071812|147386423|SUPERIORITY_OR_OTHER||percent difference from placebo|-0.1||||0.9769|TWO_SIDED|95.0|-5.6|5.4||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||5.4|-5.6|0.9769
73928527|NCT00071812|147386424|SUPERIORITY_OR_OTHER|||||||0.1752||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.1752
73928528|NCT00071812|147386424|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.3440
73928529|NCT00071812|147386424|SUPERIORITY_OR_OTHER|||||||0.4308||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.4308
73928530|NCT00071812|147386427|SUPERIORITY_OR_OTHER|||||||0.0958||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using last observation carried forward (LOCF) imputation.||||0.0958
73928531|NCT00071812|147386427|SUPERIORITY_OR_OTHER|||||||0.7864||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.7864
73928532|NCT00071812|147386427|SUPERIORITY_OR_OTHER|||||||0.0051||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.0051
73928533|NCT00071812|147386428|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.0960
73928534|NCT00071812|147386428|SUPERIORITY_OR_OTHER|||||||0.2859||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.2859
73928535|NCT00071812|147386428|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.0109
73928536|NCT00071812|147386429|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.1940
73928537|NCT00071812|147386429|SUPERIORITY_OR_OTHER|||||||0.2561||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.2561
73862723|NCT01291836|147271357|SUPERIORITY_OR_OTHER_LEGACY||ROC AUC|0.65|||||TWO_SIDED|95.0|0.598|0.702||||||Null Hypothesis: AUC ≤0.55, using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|0.702|0.598|
73862724|NCT02576860|147271379|SUPERIORITY|||||||0.799|||||||ANCOVA|||||||0.799
73928538|NCT00071812|147386429|SUPERIORITY_OR_OTHER|||||||0.8707||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.8707
73928539|NCT04127786|147386439|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95 percent (%) confidence interval (CI) of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was greater than (\>) -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.3||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Pediatric (\< 18 years)||4.3|-1.4|
73928540|NCT04127786|147386439|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|1.2|||||TWO_SIDED|95.0|-0.6|6.4||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Adult (\>=18 years)||6.4|-0.6|
73928541|NCT04127786|147386439|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.4||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Pediatric (\< 18 years)||4.4|-1.4|
73928542|NCT04127786|147386439|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.5|4.6||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Adult (\>= 18 years)||4.6|-1.5|
73928543|NCT04127786|147386440|SUPERIORITY|If the non-inferiority for VRVg-2 versus comparator vaccines was reached at Day 42, then superiority was demonstrated if the overall observed percentage of participants with an RVNA titer \>= 0.5 IU/mL at Day 42 was at least 99% in the VRVg-2 Group, with the lower limit of the 95% CI at least 97%.|Percentage Difference|100.0|||||TWO_SIDED|95.0|99.3|100.0||||||The secondary immunogenicity outcome measures were evaluated sequentially following a fixed-sequence method.||100|99.3|
73928544|NCT04127786|147386441|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.3||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Pediatric (\< 18 years)||4.3|-1.4|
73928545|NCT04127786|147386441|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-1.9|2.7||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Adult (\>=18 years)||2.7|-1.9|
73928546|NCT04127786|147386441|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.5||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Pediatric (\< 18 years)||4.5|-1.4|
73928547|NCT04127786|147386441|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-0.5|5.3||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Adult (\>= 18 years)||5.3|-0.5|
73928548|NCT04127786|147386442|NON_INFERIORITY|If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.4|||||Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Pediatric (\< 18 years)||4.4|-1.4|
73928549|NCT04127786|147386442|NON_INFERIORITY|If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.|Percentage Difference|-1.7|||||TWO_SIDED|95.0|-3.1|3.0|||||Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Adult (\>= 18 years)||3.0|-3.1|
73928550|NCT04127786|147386444|NON_INFERIORITY|If the superiority objective of VRVg-2 was reached at Day 28, the non-inferiority of 2-dose Imovax Rabies® at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the 2-dose Imovax Rabies® at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Percentage Difference|-1.3|||||TWO_SIDED|95.0|-4.4|1.3||||||Imovax Rabies® at Day 28 versus Imovax Rabies® at Day 42||1.3|-4.4|
74029446|NCT03504774|147613446|OTHER||Mean Difference (Net)|6.0||||0.61|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from week 52 to week 58||||0.61
73862725|NCT02576860|147271380|SUPERIORITY|||||||0.858|||||||Cochran-Mantel-Haenszel|||||||0.858
73862726|NCT01541917|147271386|SUPERIORITY_OR_OTHER||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.06|-0.02|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since group procedures were initiated.|Multilevel growth model evaluating average change over time (regardless of group) on the outcome variable||-.02|-.06|<.001
73928551|NCT04144166|147386521|OTHER||||||||||||||See above|||"Mean value for visual CRT and median value for device CRI were calculated for each participant. 3 values were measured (each) for CRT and CRI. Mean value is equal to SUM(m1,m2,m3)/3.~Median value was then calculated for the set (57) of calculated mean visual CRT and mean device CRI. Median value is equal to the middle value of the series of mean values. All measurements are in units of seconds."|See above|||
73928552|NCT00805935|147386555|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.000
73928553|NCT00805935|147386555|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
73970080|NCT03945292|147480496|SUPERIORITY||LS Mean Difference|-180.7|STANDARD_ERROR_OF_MEAN|74.087||0.0247|TWO_SIDED|95.0|-335.77|-25.64||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-25.64|-335.77|0.0247
73970081|NCT03945292|147480496|SUPERIORITY||LS Mean Difference|-163.79|STANDARD_ERROR_OF_MEAN|73.513||0.0382|TWO_SIDED|95.0|-317.65|-9.93||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-9.93|-317.65|0.0382
73970082|NCT03945292|147480496|SUPERIORITY||LS Mean Difference|-193.2|STANDARD_ERROR_OF_MEAN|63.089||0.0064|TWO_SIDED|95.0|-325.25|-61.15||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-61.15|-325.25|0.0064
73970083|NCT05403827|147480532|SUPERIORITY|||||||0.5019|||||||Control-Based Mean Imputation|||||||0.5019
73970084|NCT05403827|147480533|SUPERIORITY|||||||0.2028|||||||Control-Based Mean Imputation|||||||0.2028
73970085|NCT05403827|147480534|SUPERIORITY|||||||0.1914|||||||Control-Based Mean Imputation|||||||0.1914
73928554|NCT00805935|147386555|SUPERIORITY_OR_OTHER|||||||0.481||95.0|||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the menotropin treatments arms.||||0.481
73970086|NCT05403827|147480535|SUPERIORITY|||||||0.2512|||||||Control-Based Mean Imputation|||||||0.2512
73970087|NCT05403827|147480536|SUPERIORITY|||||||0.7906|||||||Control-Based Mean Imputation|||||||0.7906
73970088|NCT05403827|147480537|SUPERIORITY|||||||0.5343|||||||Control-Based Mean Imputation|||||||0.5343
73970089|NCT05403827|147480538|SUPERIORITY|||||||0.3757|||||||Control-Based Mean Imputation|||||||0.3757
73970090|NCT03628924|147480549|SUPERIORITY||Treatment difference|12.6|||=|0.166|TWO_SIDED|95.0|-4.6|29.8|||Cochran-Mantel-Haenszel|||||29.8|-4.6|= 0.166
73970091|NCT03628924|147480549|SUPERIORITY||Treatment difference|6.6|||=|0.459|TWO_SIDED|95.0|-10.3|23.6|||Cochran-Mantel-Haenszel|||||23.6|-10.3|= 0.459
73970092|NCT02043678|147480670|SUPERIORITY||Hazard Ratio (HR)|1.122||||0.2636|TWO_SIDED|95.0|0.917|1.374|||Cox Proportional Hazards Model|||||1.374|0.917|0.2636
73970093|NCT02043678|147480671|SUPERIORITY||Hazard Ratio (HR)|1.151||||0.1194|TWO_SIDED|95.0|0.964|1.374|||Cox Proportional Hazards model|||||1.374|0.964|0.1194
73970094|NCT02043678|147480672|SUPERIORITY||Hazard Ratio (HR)|1.152||||0.1283|TWO_SIDED|95.0|0.96|1.383|||Cox Proportional Hazards Model|||||1.383|0.960|0.1283
73928555|NCT00805935|147386555|SUPERIORITY_OR_OTHER|||||||0.483|TWO_SIDED|95.0|||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the follitropin beta treatment group.||||0.483
73928556|NCT01166594|147386593|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73928557|NCT01993108|147386596|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||.02
73928558|NCT01993108|147386596|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.118|TWO_SIDED||||||t-test, 2 sided|||||||.118
73928559|NCT01993108|147386596|SUPERIORITY||Median Difference (Final Values)|0.02||||0.349|TWO_SIDED||||||t-test, 2 sided|||||||.349
73970095|NCT02043678|147480673|SUPERIORITY||Hazard Ratio (HR)|1.145||||0.1669|TWO_SIDED|95.0|0.945|1.389|||Cox Proportional Hazards Model|||||1.389|0.945|0.1669
73970096|NCT02043678|147480674|SUPERIORITY||Hazard Ratio (HR)|1.033||||0.7871|TWO_SIDED|95.0|0.816|1.308|||Cox Proportional Hazards Model|||||1.308|0.816|0.7871
73928560|NCT01993108|147386596|SUPERIORITY||Median Difference (Final Values)|0.02||||0.348|TWO_SIDED||||||t-test, 2 sided|||||||.348
73928561|NCT01993108|147386597|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.019|TWO_SIDED||||||t-test, 2 sided|||||||.019
73928562|NCT01993108|147386597|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.24|TWO_SIDED||||||t-test, 2 sided|||||||.240
73928563|NCT01993108|147386597|SUPERIORITY||Median Difference (Final Values)|0.06||||0.081|TWO_SIDED||||||t-test, 2 sided|||||||.081
73928564|NCT01993108|147386597|SUPERIORITY||Median Difference (Final Values)|0.04||||0.247|TWO_SIDED||||||t-test, 2 sided|||||||.247
73928565|NCT01993108|147386598|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.049|TWO_SIDED||||||t-test, 2 sided|||||||.049
73928566|NCT01993108|147386598|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.497|TWO_SIDED||||||t-test, 2 sided|||||||.497
73928567|NCT01993108|147386598|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.814|TWO_SIDED||||||t-test, 2 sided|||||||.814
73928568|NCT01993108|147386598|SUPERIORITY||Mean Difference (Net)|0.01||||0.593|TWO_SIDED||||||t-test, 2 sided|||||||.593
73970097|NCT02043678|147480675|SUPERIORITY||Hazard Ratio (HR)|1.126||||0.2467|TWO_SIDED|95.0|0.921|1.378|||Cox Proportional Hazards Model|||||1.378|0.921|0.2467
73970098|NCT03216057|147480696|SUPERIORITY|The sample size was calculated that 130 subjects randomized in a 1:1 fashion between the 2 arms have 85% power to detect a difference of at least 20% in triglyceride percentage changes compared with placebo at week 12, assuming a common standard deviation in percentage change of 35%, a 2-sided α = 0.05, and we add 20% for lost follow-up, finally the number of subjects for each arm was 65.|Mean Difference (Net)|-24.5|||<|0.01|TWO_SIDED|95.0|-32.7|-16.2|||t-test, 2 sided|||||-16.2|-32.7|<0.01
73970099|NCT03216057|147480697|SUPERIORITY||Mean Difference (Net)|-59.9|||<|0.01|TWO_SIDED|95.0|-83.0|-36.8|||t-test, 2 sided|||||-36.8|-83.0|<0.01
73970100|NCT03216057|147480698|SUPERIORITY||Mean Difference (Net)|-9.0||||0.01|TWO_SIDED|95.0|-16.1|-1.9|||t-test, 2 sided|||||-1.9|-16.1|0.01
73970101|NCT03216057|147480699|SUPERIORITY||Mean Difference (Net)|-4.9||||0.3|TWO_SIDED|95.0|-15.8|6.05|||t-test, 2 sided|||||6.05|-15.8|0.3
73970102|NCT03216057|147480700|SUPERIORITY||Mean Difference (Net)|-12.4|||<|0.01|TWO_SIDED|95.0|-21.2|-3.5|||t-test, 2 sided|||||-3.5|-21.2|<0.01
73970103|NCT03216057|147480701|SUPERIORITY||Mean Difference (Net)|-2.2||||0.02|TWO_SIDED|95.0|-4.1|-0.3|||t-test, 2 sided|||||-0.3|-4.1|0.02
73928569|NCT01993108|147386599|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.926|TWO_SIDED||||||t-test, 2 sided|||||||.926
73928570|NCT01993108|147386599|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.126|TWO_SIDED||||||t-test, 2 sided|||||||.126
73928571|NCT01993108|147386599|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.852|TWO_SIDED||||||t-test, 2 sided|||||||.852
73928572|NCT01993108|147386599|SUPERIORITY||Median Difference (Final Values)|0.11||||0.552|TWO_SIDED||||||t-test, 2 sided|||||||.552
73928573|NCT02775344|147386630|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.198|TWO_SIDED||||||Chi-squared, Corrected|||||||0.198
73970104|NCT03216057|147480702|SUPERIORITY||Mean Difference (Net)|-1.2||||0.6|TWO_SIDED|95.0|-6.3|3.8|||t-test, 2 sided|||||3.8|-6.3|0.6
73970105|NCT03216057|147480703|SUPERIORITY||Mean Difference (Net)|1.9||||0.1|TWO_SIDED|95.0|-0.9|4.9|||t-test, 2 sided|||||4.9|-0.9|0.1
73970106|NCT03216057|147480704|SUPERIORITY||Mean Difference (Net)|13.4|||<|0.01|TWO_SIDED|95.0|5.8|21.0|||t-test, 2 sided|||||21|5.8|<0.01
73970107|NCT03216057|147480705|SUPERIORITY||Mean Difference (Net)|0.8|||<|0.01|TWO_SIDED|95.0|0.4|1.2|||t-test, 2 sided|||||1.2|0.4|<0.01
73928574|NCT02775344|147386631|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.393|TWO_SIDED||||||Chi-squared, Corrected|||||||0.393
73928575|NCT02402452|147386649|OTHER||Geometric Least-Square Mean(GLSM)Ratio %|172.92|||||TWO_SIDED|90.0|97.93|305.33||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.||305.33|97.93|
73928576|NCT02402452|147386650|OTHER||GLSM Ratio (%)|171.27|||||TWO_SIDED|90.0|97.65|300.38||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.||300.38|97.65|
73928577|NCT02402452|147386651|OTHER||GLSM Ratio (%)|145.43|||||TWO_SIDED|90.0|83.77|252.48||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of Cmax for the comparison groups using two 1-sided tests.||252.48|83.77|
73928578|NCT00559962|147386653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68|||<|0.001|TWO_SIDED|95.0|2.3|7.07|||ANOVA|||One-way analysis of variance (ANOVA) to compare the absolute change from baseline to Week 12 in percent hepatic fat between AEGR-755 5 mg and placebo.||7.07|2.30|<0.001
73928579|NCT00559962|147386654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.92|||<|0.001|TWO_SIDED|95.0|2.27|7.57||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||7.57|2.27|<0.001
73928580|NCT00559962|147386654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68|||<|0.001|TWO_SIDED|95.0|2.3|7.07||(All comparisons)|ANOVA|||||7.07|2.30|<0.001
73928581|NCT00559962|147386654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.91|||<|0.001|TWO_SIDED|95.0|1.73|6.1||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||6.10|1.73|<0.001
73928582|NCT00559962|147386654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.82|||<|0.001|TWO_SIDED|95.0|4.31|11.33||(All comparisons)|ANOVA|||||11.33|4.31|<0.001
73928583|NCT00559962|147386654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||<|0.001|TWO_SIDED|95.0|1.58|5.72||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||5.72|1.58|<0.001
73928584|NCT00559962|147386654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.66|||<|0.001|TWO_SIDED|95.0|4.22|11.11||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||11.11|4.22|<0.001
73928585|NCT00559962|147386654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.51|||<|0.001|TWO_SIDED|95.0|5.16|9.86||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||9.86|5.16|<0.001
73928586|NCT01461096|147386655|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.35|TWO_SIDED|95.1|0.47|1.31||P-value was unadjusted for multiple comparisons and a P-value less than 5% was the threshold for statistical significance.|generalized log-rank test (Sun 1996)|The generalized log-rank test (Sun 1996) was performed to evaluate whether participants in the two arms had the same survival rate.|qHPV group represented the numerator for the hazard ratio and Placebo group represented the denominator.|||1.31|0.47|0.350
73928587|NCT00915798|147386685|SUPERIORITY_OR_OTHER||F|0.56||||0.46|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Frontal BOLD during abstinence in smokers and nonsmokers||||0.46
73970108|NCT04568603|147480706|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the 90% CI for the geometric mean ratio (GMR) of methadone+ ISL to methadone alone is contained within the interval (0.70, 1.43).|GMR|1.03|||||TWO_SIDED|90.0|1.0|1.07||||||||1.07|1.00|
73970109|NCT04568603|147480707|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.03|||||TWO_SIDED|90.0|0.99|1.07||||||||1.07|0.99|
73970110|NCT04568603|147480708|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 1.43.|GMR|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||||1.09|0.96|
73970111|NCT04568603|147480709|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.06|||||TWO_SIDED|90.0|1.03|1.1||||||||1.10|1.03|
73970112|NCT04568603|147480711|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.01|||||TWO_SIDED|90.0|0.94|1.09||||||||1.09|0.94|
73862727|NCT01541917|147271386|SUPERIORITY_OR_OTHER||Slope|-0.014|STANDARD_ERROR_OF_MEAN|0.021||0.51|TWO_SIDED|95.0|-0.055|0.027|||Multilevel growth model||The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.027|-.055|.51
73862728|NCT01541917|147271387|SUPERIORITY_OR_OTHER||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|0.27|0.46|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||.46|.27|<.001
73928588|NCT00915798|147386685|SUPERIORITY_OR_OTHER||F|6.64||||0.012|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05|Diagnosis by smoking status interaction.|Parietal BOLD during abstinence in smokers and nonsmokers||||0.012
73928589|NCT00915798|147386685|SUPERIORITY_OR_OTHER||F|211.2||||0.04|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05|Main effect for smoking status.|Occipital BOLD during abstinence in smokers and nonsmokers.||||0.04
73928590|NCT00915798|147386685|SUPERIORITY_OR_OTHER||F|1.6||||0.22|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Frontal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.22
73928591|NCT00915798|147386685|SUPERIORITY_OR_OTHER||F|0.43||||0.51|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Parietal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.51
73970113|NCT04568603|147480712|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.08|||||TWO_SIDED|90.0|1.04|1.13||||||||1.13|1.04|
73928592|NCT00915798|147386685|SUPERIORITY_OR_OTHER||F|0.16||||0.69|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Occipital BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.69
73928593|NCT02281552|147386716|NON_INFERIORITY|Non-inferiority of tofacitinib MR 11 mg QD to IR 5 mg BID was concluded if the upper bound of the 2-sided 95% confidence interval of differences between the treatment groups (MR 11 mg QD - IR 5 mg BID) at Week 12 was less than the pre-specified non-inferiority margin of 0.6.|Least Square (LS) mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.17|0.69||||||Analysis was conducted using a linear mixed effect model with repeated measures (MMRM), which included treatment (tofacitinib MR 11 mg QD and IR 5 mg BID), visit, and treatment by visit interaction as fixed effects and participants as a random effect.||0.69|0.17|
73970114|NCT04568603|147480714|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.03|||||TWO_SIDED|90.0|0.99|1.07||||||||1.07|0.99|
73970115|NCT04568603|147480715|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||||1.08|0.95|
73970116|NCT04568603|147480716|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.07|||||TWO_SIDED|90.0|1.03|1.11||||||||1.11|1.03|
73970117|NCT04564742|147480720|SUPERIORITY||Win Ratio (WR)|1.34|||<|0.001|TWO_SIDED|95.0|1.2|1.5||A closed testing procedure including a pre-specified hierarchical ordering of the primary and secondary endpoints was utilised. No multiplicity control was placed on the exploratory endpoints.|Win Ratio Analysis|||The primary objective of the study was to determine if the clinical benefit of dapagliflozin was superior as compared with placebo, utilizing a hierarchical composite endpoint and win-ratio (WR) method. With a presumed WR of 1.20, 4000 patients were provide an 80% statistical power for the primary endpoint, maintaining a 1:1 allocation between treatments. The primary analysis was based on the intention-to-treat principle using the Full Analysis Set.||1.50|1.20|<0.001
73970118|NCT03313076|147480728|SUPERIORITY||Slope|-0.84||||0.276|TWO_SIDED|95.0|-2.32|0.63||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||||0.63|-2.32|0.276
73970119|NCT03313076|147480728|SUPERIORITY||Slope|0.72||||0.336|TWO_SIDED|95.0|-0.71|2.14||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||||2.14|-0.71|0.336
73970120|NCT03313076|147480728|SUPERIORITY||Slope|-2.33||||0.004|TWO_SIDED|95.0|-3.76|-0.9||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||Sensitivity analysis adjusting for an influential observation (using the dfbeta approach) that could produce spurious results from a small trial dataset||-0.9|-3.76|0.004
74029447|NCT03504774|147613446|OTHER||Mean Difference (Net)|8.5||||0.034|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 52||||0.034
73928594|NCT03465878|147386745|SUPERIORITY||Ratio of geometric least squares means|0.999||||0.9813|TWO_SIDED|95.0|0.918|1.09|||Mixed Models Analysis|||||1.09|0.918|0.9813
73928595|NCT03465878|147386745|SUPERIORITY||Ratio of geometric least squares means|1.06||||0.1638|TWO_SIDED|95.0|0.976|1.15|||Mixed Models Analysis|||||1.15|0.976|0.1638
73928596|NCT03465878|147386745|SUPERIORITY||Ratio of geometric least squares means|1.01||||0.7623|TWO_SIDED|95.0|0.933|1.1|||Mixed Models Analysis|||||1.10|0.933|0.7623
73928597|NCT03465878|147386745|SUPERIORITY||Ratio of geometric least squares means|1.04||||0.2952|TWO_SIDED|95.0|0.962|1.13|||Mixed Models Analysis|||||1.13|0.962|0.2952
74029448|NCT03504774|147613446|OTHER||Mean Difference (Net)|0.8||||0.45|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 58||||0.45
73928598|NCT03465878|147386745|SUPERIORITY||Ratio of geometric least squares means|0.97||||0.4052|TWO_SIDED|95.0|0.901|1.04|||Mixed Models Analysis|||||1.04|0.901|0.4052
73928599|NCT03465878|147386745|SUPERIORITY||Ratio of geometric least squares means|1.02||||0.5314|TWO_SIDED|95.0|0.948|1.11|||Mixed Models Analysis|||||1.11|0.948|0.5314
73928600|NCT02540954|147386755|NON_INFERIORITY|Non-inferiority margin is 5 letters.|Least squares mean difference|0.22|||<|0.0001|TWO_SIDED|95.0|-1.51|1.96|||ANCOVA|||||1.96|-1.51|< 0.0001
73928601|NCT02540954|147386756|NON_INFERIORITY|Non inferiority margin is 7%.|Treatment difference in %|1.1|||||TWO_SIDED|95.0|-3.7|6.0||||||||6.0|-3.7|
73928602|NCT02540954|147386761|OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-4.152|0.392||||||||0.392|-4.152|
73928603|NCT02643251|147386794|SUPERIORITY|||||||0.3361|||||||Mixed Models Analysis|||||||0.3361
73928604|NCT02365636|147386811|SUPERIORITY||LSM difference from placebo|0.32||||0.13|TWO_SIDED|95.0|-0.094|0.726||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.||0.726|-0.094|0.130
73928605|NCT02365636|147386811|SUPERIORITY||LSM difference from placebo|0.24||||0.245|TWO_SIDED|95.0|-0.167|0.652||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.||0.652|-0.167|0.245
73928606|NCT02365636|147386812|SUPERIORITY||LSM difference from placebo|0.32||||0.128|TWO_SIDED|95.0|-0.093|0.735||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.735|-0.093|0.128
73928607|NCT02365636|147386812|SUPERIORITY||LSM difference from placebo|0.27||||0.194|TWO_SIDED|95.0|-0.14|0.688||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.688|-0.140|0.194
73928608|NCT02365636|147386813|SUPERIORITY||LSM difference from placebo|0.28||||0.177|TWO_SIDED|95.0|-0.128|0.691||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.||0.691|-0.128|0.177
73928609|NCT02365636|147386813|SUPERIORITY||LSM difference from placebo|0.2||||0.325|TWO_SIDED|95.0|-0.204|0.614||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.||0.614|-0.204|0.325
73970121|NCT03313076|147480728|SUPERIORITY||Slope|0.92||||0.139|TWO_SIDED|95.0|-0.25|2.09||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||Sensitivity analysis adjusting for an influential observation (using the dfbeta approach) that could produce spurious results from a small trial dataset||2.09|-0.25|0.139
73970122|NCT03904147|147480740|SUPERIORITY||Win Ratio|1.44||||0.0311|TWO_SIDED||||||Finkelstein-Schoenfeld Method||The Win Ratio provides an estimation of the treatment effect.|||||0.0311
73970123|NCT03904147|147480741|SUPERIORITY|||||||0.0008|||||||exact test|||||||0.0008
73970124|NCT03904147|147480742|SUPERIORITY||||||<|0.0001|||||||Z test|||||||<0.0001
73970125|NCT03904147|147480743|SUPERIORITY||||||<|0.0001|||||||ANCOVA model|||||||<0.0001
73970126|NCT03904147|147480744|SUPERIORITY||||||<|0.0001|||||||Chi-square test|||||||<0.0001
73970127|NCT03904147|147480745|SUPERIORITY|||||||0.2482|||||||ANCOVA model|||||||0.2482
73970128|NCT03904147|147480746|SUPERIORITY||||||<|0.0001|||||||Exact test|||||||<0.0001
73970129|NCT03904147|147480747|SUPERIORITY||||||<|0.0001|||||||Binomial exact method|||||||<0.0001
73970130|NCT03904147|147480748|SUPERIORITY|||||||0.109|||||||normal approximation|||||||0.1090
73970131|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|-1.29||||0.27|TWO_SIDED|95.0|-3.6|1.03|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||1.03|-3.60|0.27
73970132|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|-0.25||||0.83|TWO_SIDED|95.0|-2.53|2.04|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||2.04|-2.53|0.83
73970133|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|-2.01||||0.08|TWO_SIDED|95.0|-4.3|0.28|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.28|-4.30|0.08
73970134|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|-1.56||||0.16|TWO_SIDED|95.0|-3.77|0.65|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.65|-3.77|0.16
73970135|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|-1.65||||0.14|TWO_SIDED|95.0|-3.84|0.54|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.54|-3.84|0.14
73970136|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|-2.46||||0.04|TWO_SIDED|95.0|-4.47|-0.17|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||-0.17|-4.47|0.04
73970137|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|2.46||||0.04|TWO_SIDED|95.0|0.17|4.74|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||4.74|0.17|0.04
73928610|NCT02365636|147386814|SUPERIORITY||LSM difference from placebo|0.29||||0.202|TWO_SIDED|95.0|-0.158|0.741||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.741|-0.158|0.202
73928611|NCT02365636|147386814|SUPERIORITY||LSM difference from placebo|0.457||||0.457|TWO_SIDED|95.0|-0.28|0.621||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.621|-0.280|0.457
73928612|NCT02365636|147386815|SUPERIORITY||Odds Ratio (OR)|0.92||||0.815|TWO_SIDED|95.0|0.456|1.856||5% level of significance|Regression, Logistic|||\>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||1.856|0.456|0.815
73928613|NCT02365636|147386815|SUPERIORITY||Odds Ratio (OR)|1.05||||0.893|TWO_SIDED|95.0|0.52|2.117||5% level of significance|Regression, Logistic|||\>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||2.117|0.520|0.893
73928614|NCT02365636|147386815|SUPERIORITY||Odds Ratio (OR)|0.74||||0.43|TWO_SIDED|95.0|0.357|1.55||5% level of significance|Regression, Logistic|||\>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||1.550|0.357|0.430
73928615|NCT02365636|147386815|SUPERIORITY||Odds Ratio (OR)|1.02||||0.967|TWO_SIDED|95.0|0.494|2.088||5% level of significance|Regression, Logistic|||\>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||2.088|0.494|0.967
73928616|NCT02365636|147386816|SUPERIORITY||LSM of difference with placebo|2.2||||0.251|TWO_SIDED|95.0|-1.55|5.92||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||5.92|-1.55|0.251
73928617|NCT02365636|147386816|SUPERIORITY||LSM difference from placebo|1.3||||0.495|TWO_SIDED|95.0|-2.46|5.07||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||5.07|-2.46|0.495
73928618|NCT02365636|147386816|SUPERIORITY||LSM difference from placebo|3.1||||0.123|TWO_SIDED|95.0|-0.84|7.06||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||7.06|-0.84|0.123
73928619|NCT02365636|147386816|SUPERIORITY||LSM difference from placebo|2.8||||0.16|TWO_SIDED|95.0|-1.12|6.77||5% level of significance.|miex model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||6.77|-1.12|0.160
73928620|NCT02365636|147386817|SUPERIORITY||LSM difference from placebo|1.3||||0.609|TWO_SIDED|95.0|-3.81|6.48||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.||||6.48|-3.81|0.609
73928621|NCT02365636|147386817|SUPERIORITY||LSM difference with placebo|2.1||||0.427|TWO_SIDED|95.0|-3.05|7.19||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.||||7.19|-3.05|0.427
73928622|NCT02365636|147386818|SUPERIORITY||LSM difference from placebo|0.2||||0.166|TWO_SIDED|95.0|-0.07|0.43||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.43|-0.07|0.166
73928623|NCT02365636|147386818|SUPERIORITY||LSM difference from placebo|0.3||||0.046|TWO_SIDED|95.0|0.0|0.51||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.51|0.00|0.046
73928624|NCT02365636|147386818|SUPERIORITY||LSM difference from placebo|0.2||||0.152|TWO_SIDED|95.0|-0.08|0.53||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.53|-0.08|0.152
73970138|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|1.17||||0.32|TWO_SIDED|95.0|-1.14|3.48|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.48|-1.14|0.32
73970139|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|2.21||||0.06|TWO_SIDED|95.0|-0.08|4.5|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||4.50|-0.08|0.06
73970140|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|0.45||||0.7|TWO_SIDED|95.0|-1.84|2.73|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||2.73|-1.84|0.70
73970141|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|0.9||||0.42|TWO_SIDED|95.0|-1.31|3.1|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.10|-1.31|0.42
73970142|NCT01037881|147480751|SUPERIORITY||Difference in least squares mean|0.81||||0.47|TWO_SIDED|95.0|-1.38|3.0|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.00|-1.38|0.47
73970143|NCT00764751|147480757|SUPERIORITY||Mean Difference (Final Values)|15.4|||=|0.003|TWO_SIDED|95.0|5.6|25.0|||Paired t-test|||||25|5.6|=0.003
73970144|NCT00764751|147480757|SUPERIORITY||Mean Difference (Final Values)|-17.1||||0.07|TWO_SIDED|95.0|-36.0|1.9|||Paired t-test|||||1.9|-36.0|0.07
73970145|NCT04563546|147480766|OTHER||||||<|0.001||||||Unadjusted p-value. Threshold for statistical significance = 0.05|Chi-squared|||||||<0.001
73970146|NCT04563546|147480767|OTHER|||||||0.739|||||||Chi-squared|||||||0.739
73970147|NCT04563546|147480768|OTHER||||||<|0.001||||||Unadjusted p-value. Threshold for statistical significance = 0.05|Chi-squared|||||||<0.001
73970148|NCT04413708|147480833|SUPERIORITY||Risk Ratio (RR)|1.62||||0.41|TWO_SIDED|95.0|0.5|5.17|||Fisher Exact|||||5.17|0.50|0.41
73970149|NCT04413708|147480834|SUPERIORITY||Risk Ratio (RR)|1.07||||1|TWO_SIDED|95.0|0.61|1.9|||Fisher Exact|||||1.90|0.61|1.0
73970150|NCT03994653|147480848|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|2.07|4.12|||Fisher Exact|||"Fishers exact test, conducted at each month prior to diagnosis comparing total purchases of relevant products (pain and indigestion medication) compared with all purchases in both cases and controls.~Power calculation: we used a power calculation assuming the Fisher Exact Test to calculate the minimum group size to detect a difference in purchase proportions that we hypothesised with 80% statistical power."||4.12|2.07|<0.001
73970151|NCT02465268|147480885|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.196|TWO_SIDED|95.0|0.77|2.16|||Log Rank|||||2.16|0.77|0.196
74029449|NCT03504774|147613446|OTHER||Mean Difference (Net)|7.7||||0.12|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from week 52 to week 58||||0.12
74029450|NCT03504774|147613446|OTHER||Mean Difference (Net)|1.0||||0.83|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 52||||0.83
74029451|NCT03504774|147613446|OTHER||Mean Difference (Net)|2.0||||0.67|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 58||||0.67
73970152|NCT02465268|147480885|SUPERIORITY||Hazard Ratio (HR)|1.63||||0.196|TWO_SIDED|95.0|0.99|2.7|||Log Rank|||||2.70|0.99|0.196
73970153|NCT02465268|147480886|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.354|TWO_SIDED|95.0|0.6|1.61|||Log Rank|||||1.61|0.60|0.354
73970154|NCT02465268|147480886|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.354|TWO_SIDED|95.0|0.87|2.33|||Log Rank|||||2.33|0.87|0.354
74029452|NCT03504774|147613446|OTHER||Mean Difference (Net)|1.0||||0.8|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from week 52 to week 58||||0.80
74029453|NCT03504774|147613446|OTHER||Mean Difference (Net)|1.7||||0.46|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 52||||0.46
73970155|NCT02465268|147480887|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
73970156|NCT02465268|147480887|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
73970157|NCT02465268|147480887|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
73970158|NCT02465268|147480889|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
73970159|NCT02465268|147480889|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
73970160|NCT02465268|147480889|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
73970161|NCT02465268|147480890|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||||||0.6
73970162|NCT02465268|147480890|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||||||0.6
73970163|NCT02465268|147480890|OTHER|||||||0.6|||||||Kruskal-Wallis|||||||0.6
73970164|NCT02465268|147480892|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
73970165|NCT02465268|147480892|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
73970166|NCT02465268|147480892|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
73970167|NCT03133546|147480898|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.84|TWO_SIDED|95.0|0.68|1.37||significance level: 5%|Regression, Cox|Univariate Cox for PFS with treatment effect only|The HR for Osimertinib plus Bevacizumab versus Osimertinib alone is provided.|"Assumption: Median PFS with osimertinib 11 months Target: Detect a 36% improvement in PFS (HR=0.64, corresponding to an increase in median PFS to 17.2 months) under osimertinib and bevacizumab (80% power, at one-sided significant level of 5%)~126 events required"||1.37|0.68|0.84
73970168|NCT03468868|147480904|NON_INFERIORITY|We chose a non-inferiority margin of 10% (or 0.10 feet per second) for this population.|Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|1.1|<|0.01|TWO_SIDED|95.0|-0.14|0.44|||t-test, 2 sided|||||0.44|-0.14|<0.01
73970169|NCT03468868|147480905|SUPERIORITY||Mean Difference (Final Values)|72.46|STANDARD_DEVIATION|384.1||0.16|TWO_SIDED|95.0|-29.56|174.5|||t-test, 2 sided|||||174.5|-29.56|0.16
73970170|NCT03468868|147480906|SUPERIORITY||Mean Difference (Final Values)|-4.71|STANDARD_DEVIATION|24.96||0.13|TWO_SIDED|95.0|-10.84|1.41|||t-test, 2 sided|||||1.41|-10.84|0.13
73970171|NCT03468868|147480907|SUPERIORITY||Mean Difference (Final Values)|0.88|STANDARD_DEVIATION|18.22||0.7|TWO_SIDED|95.0|-3.55|5.32|||t-test, 2 sided|||||5.32|-3.55|0.70
73970172|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|6.71||0.43|TWO_SIDED|95.0|-0.97|2.3|||t-test, 2 sided|||NeuroQOL Anxiety Domain||2.30|-0.97|0.43
73970173|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|6.16||0.75|TWO_SIDED|95.0|-1.26|1.74|||t-test, 2 sided|||NeuroQOL Depression Domain||1.74|-1.26|0.75
74029454|NCT03504774|147613446|OTHER||Mean Difference (Net)|3.2||||0.48|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 58||||0.48
74029455|NCT03504774|147613446|OTHER||Mean Difference (Net)|3.2||||0.25|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from week 52 to week 58||||0.25
74029456|NCT03504774|147613446|OTHER||Mean Difference (Net)|2.6||||0.14|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 52||||0.14
74029457|NCT03504774|147613446|OTHER||Mean Difference (Net)|0.6||||0.73|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 58||||0.73
74029458|NCT03504774|147613446|OTHER||Mean Difference (Net)|2.0||||0.16|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from week 52 to week 58||||0.16
74029459|NCT03504774|147613446|OTHER||Mean Difference (Net)|1.8||||0.47|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 52||||0.47
73970174|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_DEVIATION|7.54||0.35|TWO_SIDED|95.0|-2.71|0.97|||t-test, 2 sided|||NeuroQOL Fatigue Domain||0.97|-2.71|0.35
73970175|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|3.83||0.91|TWO_SIDED|95.0|-0.88|0.99|||t-test, 2 sided|||NeuroQOL Upper Extremity Function Domain||0.99|-0.88|0.91
73970176|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|1.52|STANDARD_DEVIATION|5.44||0.02|TWO_SIDED|95.0|0.2|2.85|||t-test, 2 sided|||NeuroQOL Lower Extremity Function Domain||2.85|0.20|0.02
73970177|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.29|TWO_SIDED|95.0|-2.54|0.76|||t-test, 2 sided|||NeuroQOL Cognitive Function Domain||0.76|-2.54|0.29
73970178|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|1.08||||0.11|TWO_SIDED|95.0|-0.26|2.42|||t-test, 2 sided|||NeuroQOL Emotional and Behavioral Dyscontrol Domain||2.42|-0.26|0.11
73970179|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_DEVIATION|7.13||0.54|TWO_SIDED|95.0|-1.19|2.28|||t-test, 2 sided|||NeuroQOL Positive Affect and Well-Being Domain||2.28|-1.19|0.54
73970180|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_DEVIATION|5.76||0.41|TWO_SIDED|95.0|-2.0|0.81|||t-test, 2 sided|||NeuroQOL Sleep Disturbance Domain||0.81|-2.00|0.41
73970181|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|6.65||0.63|TWO_SIDED|95.0|-1.22|2.02|||t-test, 2 sided|||NeuroQOL Ability to Participate in Social Roles and Activities Domain||2.02|-1.22|0.63
73970182|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|7.44||0.48|TWO_SIDED|95.0|-1.16|2.47|||t-test, 2 sided|||NeuroQOL Satisfaction with Social Roles and Activities Domain||2.47|-1.16|0.48
73970183|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|5.68||0.92|TWO_SIDED|95.0|-1.32|1.45|||t-test, 2 sided|||NeuroQOL Stigma Domain||1.45|-1.32|0.92
73970184|NCT03468868|147480908|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_DEVIATION|3.45||0.28|TWO_SIDED|95.0|-1.31|0.37|||t-test, 2 sided|||NeuroQOL Communication Domain||0.37|-1.31|0.28
73970185|NCT03468868|147480909|SUPERIORITY||Mean Difference (Final Values)|-2.48|STANDARD_DEVIATION|20.63||0.34|TWO_SIDED|95.0|-7.55|2.6|||t-test, 2 sided|||MSIS Physical||2.60|-7.55|0.34
73970186|NCT03468868|147480909|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_DEVIATION|21.37||0.24|TWO_SIDED|95.0|-6.63|3.88|||t-test, 2 sided|||MSIS Psychological||3.88|-6.63|0.24
73970187|NCT03468868|147480910|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_DEVIATION|8.91||0.74|TWO_SIDED|95.0|-1.83|2.56|||t-test, 2 sided|||MFIS Cognitive||2.56|-1.83|0.74
73970188|NCT03468868|147480910|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|8.03||0.04|TWO_SIDED|95.0|-4.07|-0.12|||t-test, 2 sided|||MFIS Physical||-0.12|-4.07|0.04
73970189|NCT03468868|147480910|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_DEVIATION|2.17||0.59|TWO_SIDED|95.0|-0.68|0.39|||t-test, 2 sided|||MFIS Psychosocial||0.39|-0.68|0.59
73970190|NCT03468868|147480910|SUPERIORITY||Mean Difference (Final Values)|-1.88|STANDARD_DEVIATION|17.0||0.38|TWO_SIDED|95.0|-6.05|2.3|||t-test, 2 sided|||MFIS Total||2.30|-6.05|0.38
73970191|NCT03468868|147480911|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|1.18||0.87|TWO_SIDED|95.0|-0.34|0.29|||t-test, 2 sided|||||0.29|-0.34|0.87
73970192|NCT03468868|147480912|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_DEVIATION|2.21||0.05|TWO_SIDED|95.0|-1.08|0.0|||t-test, 2 sided|||||0.00|-1.08|0.05
73970193|NCT05399459|147480913|SUPERIORITY||Adjusted percentage difference|19.4|||<|0.0001|TWO_SIDED|95.0|12.0|26.8|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg - placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||26.8|12.0|<0.0001
73970194|NCT05399459|147480914|SUPERIORITY||Adjusted percentage difference|22.7|||<|0.0001|TWO_SIDED|95.0|14.5|30.9|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg - placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||30.9|14.5|<0.0001
73970195|NCT05399459|147480915|SUPERIORITY||Adjusted percentage difference|14.8||||0.0011|TWO_SIDED|95.0|5.9|23.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||23.6|5.9|0.0011
73970196|NCT05399459|147480916|SUPERIORITY||Adjusted percentage difference|18.8|||<|0.0001|TWO_SIDED|95.0|10.1|27.4|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||27.4|10.1|<0.0001
73970197|NCT05399459|147480917|SUPERIORITY||Adjusted percentage difference|31.7|||<|0.0001|TWO_SIDED|95.0|23.2|40.3|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||40.3|23.2|<0.0001
73970198|NCT05399459|147480918|SUPERIORITY||Adjusted percentage difference|-19.7|||<|0.0001|TWO_SIDED|95.0|-27.8|-11.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||-11.6|-27.8|<0.0001
73970199|NCT05399459|147480919|SUPERIORITY||Adjusted percentage difference|33.1|||<|0.0001|TWO_SIDED|95.0|24.7|41.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||41.6|24.7|<0.0001
73970200|NCT05399459|147480920|SUPERIORITY||Adjusted percentage difference|10.1||||0.0707|TWO_SIDED|95.0|-0.9|21.1||P-value \> 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||21.1|-0.9|0.0707
73970201|NCT00986856|147480931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|13.2|||<|0.01||95.0|1.4|120.4||Test for the hypothesis of odds ratio equal to 1.|Cochran-Mantel-Haenszel|||||120.4|1.4|<0.01
73970202|NCT00986856|147480932|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.7||||0.023||95.0|1.1|28.6|||Cochran-Mantel-Haenszel|||||28.6|1.1|0.023
73970203|NCT00986856|147480933|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7||||0.54|TWO_SIDED|95.0|0.3|8.1|||Cochran-Mantel-Haenszel|||||8.1|0.3|0.54
73970204|NCT00986856|147480934|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.7||||0.1|TWO_SIDED|95.0|0.8|8.8|||Cochran-Mantel-Haenszel|||||8.8|0.8|0.1
73970205|NCT00986856|147480935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Cochran-Mantel-Haenszel|||||||0.1
73970206|NCT00986856|147480936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5||||0.043||95.0|0.9|83.5|||Cochran-Mantel-Haenszel|||||83.5|0.9|0.043
73928625|NCT02365636|147386818|SUPERIORITY||LSM difference from placebo|0.1||||0.342|TWO_SIDED|95.0|-0.16|0.46||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.46|-0.16|0.342
73928626|NCT02365636|147386819|SUPERIORITY||LSM difference from placebo|0.2||||0.311|TWO_SIDED|95.0|-0.22|0.7||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.70|-0.22|0.311
73928627|NCT02365636|147386819|SUPERIORITY||LSM difference from placebo|0.3||||0.262|TWO_SIDED|95.0|-0.2|0.73||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.73|-0.20|0.262
73928628|NCT02365636|147386819|SUPERIORITY||LSM difference from placebo|0.5||||0.065|TWO_SIDED|95.0|-0.03|0.97||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.97|-0.03|0.065
73928629|NCT02365636|147386819|SUPERIORITY||LSM difference from placebo|0.3||||0.296|TWO_SIDED|95.0|-0.23|0.76||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.76|-0.23|0.296
73928630|NCT02365636|147386820|SUPERIORITY|||||||0.245||||||5% level of significance|Regression, Cox|||||||0.245
73928631|NCT02365636|147386820|SUPERIORITY|||||||0.304||||||5% level of significance|Regression, Cox|||||||0.304
73928632|NCT02365636|147386821|SUPERIORITY||LSM difference from placebo|-0.1||||0.556|TWO_SIDED|95.0|-0.61|0.33||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.33|-0.61|0.556
73928633|NCT02365636|147386821|SUPERIORITY||LSM difference from placebo|-0.2||||0.482|TWO_SIDED|95.0|-0.65|0.31||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.31|-0.65|0.482
73928634|NCT02365636|147386821|SUPERIORITY||LSM difference from placebo|-0.3||||0.333|TWO_SIDED|95.0|-0.81|0.28||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.28|-0.81|0.333
73928635|NCT02365636|147386821|SUPERIORITY||LSM difference from placebo|-0.1||||0.833|TWO_SIDED|95.0|-0.62|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.50|-0.62|0.833
74088046|NCT02709486|147729970|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.07|<.0001
73928636|NCT02365636|147386822|SUPERIORITY||LSM difference from placebo|-0.2||||0.563|TWO_SIDED|95.0|-0.75|0.41||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.41|-0.75|0.563
73928637|NCT02365636|147386822|SUPERIORITY||LSM difference from placebo|-0.1||||0.804|TWO_SIDED|95.0|-0.64|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.50|-0.64|0.804
73928638|NCT02365636|147386822|SUPERIORITY||LSM difference from placebo|0.1||||0.714|TWO_SIDED|95.0|-0.49|0.71||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.71|-0.49|0.714
73928639|NCT02365636|147386822|SUPERIORITY||LSM difference from placebo|0.0||||0.871|TWO_SIDED|95.0|-0.64|0.55||5% level of siignificance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.55|-0.64|0.871
73928640|NCT01236196|147386834|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
73928641|NCT01236196|147386835|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
73928642|NCT01236196|147386836|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
73928643|NCT01236196|147386837|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.09
73928644|NCT01802775|147386839|OTHER||Treatment Difference|-3.9|||||TWO_SIDED|95.0|-17.3|9.5||||||Treatment difference was edoxaban - clopidogrel. For the treatment difference, 95% Confidence interval was calculated using a normal approximation to the binomial distribution.||9.5|-17.3|
73928645|NCT00386256|147386844|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.||||<.05
73928646|NCT00386256|147386845|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.||||<.05
73928647|NCT01096784|147386849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0642||95.0|||||CMH Row Mean Score Test|||||||0.0642
73928648|NCT03064126|147386867|SUPERIORITY||Risk Difference (RD)|0.166||||0.0017|ONE_SIDED|97.5|0.0553||||Chi-squared||||||0.0553|0.0017
73928649|NCT03064126|147386868|NON_INFERIORITY|A Chi-Square Test was used to assess the hypothesis for the difference in 12-month MAE-free rate with non-inferiority margin (-10%).|Risk Difference (RD)|0.106|||<|0.0001|ONE_SIDED|97.5|0.0248||||Chi-squared||||||0.0248|<0.0001
73928650|NCT00846742|147386937|SUPERIORITY|||||||0.0003||||||Comparison of proportion of patients' complete response rate between HOD99 (NCT number: NCT00145600) and HOD08|Exact Binominal Test|||The proportion of patients' complete response rate was provided with a 95% confidence interval.||||0.0003
73928651|NCT00846742|147386942|SUPERIORITY||Hazard Ratio (HR)|0.969||||0.732|TWO_SIDED|95.0|0.81|1.159|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure with a 1-year increase in age.|||1.159|0.810|0.732
73928652|NCT00846742|147386943|SUPERIORITY||Hazard Ratio (HR)|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing males to females.|Male vs. Female, with Female as the reference level||0.000|0.000|<0.001
73928653|NCT00846742|147386944|SUPERIORITY||Hazard Ratio (HR)|30101.41|||<|0.001|TWO_SIDED|95.0|3329.573|272135.5|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing Stage IIA to Stage IA.|Stage IIA vs. Stage IA, with Stage IA as the reference level||272135.500|3329.573|<0.001
73928654|NCT00846742|147386945|SUPERIORITY||Hazard Ratio (HR)|34027.68|||<|0.001|TWO_SIDED|95.0|4072.872|284291.6|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing Classical (all combined) to Nodular Lymphocyte Predominant Hodgkin Lymphoma.|Classical (all combined) vs. Nodular lymphocyte predominant, with Nodular lymphocyte predominant as the reference level||284291.600|4072.872|<0.001
73928655|NCT00846742|147386946|SUPERIORITY|||||||0.461|||||||Log Rank|||Comparing the 2-year EFS between HOD08 Participants and HOD99 Participants||||0.461
73928656|NCT00846742|147386946|SUPERIORITY|||||||1|||||||Log Rank|||Comparing the 2-year OS between HOD08 Participants and HOD99 Participants||||1.000
73928657|NCT00846742|147386946|SUPERIORITY|||||||0.836|||||||Gray's test|||Comparing the 2-year CI of Local Failure between HOD08 Participants and HOD99 Participants||||0.836
73928658|NCT00846742|147386948|SUPERIORITY|||||||0.384|||||||Log Rank|||Comparing the 2-year EFS between HOD08 - CR and HOD99 - CR||||0.384
73928659|NCT00846742|147386948|SUPERIORITY|||||||1|||||||Log Rank|||Comparing the 2-year OS between HOD08 - CR and HOD99 - CR||||1.000
73928660|NCT00846742|147386948|SUPERIORITY|||||||0.386|||||||Gray's test|||Comparing the 2-year CI of Local Failure between HOD08 - CR and HOD99 - CR||||0.386
73928661|NCT00846742|147386949|SUPERIORITY|||||||0.986|||||||Log Rank|||Comparing the 2-year EFS of patients treated without and with RT||||0.986
73928662|NCT03909165|147386956|OTHER||Geometric Mean Ratio (GMR)|0.83|||||TWO_SIDED|90.0|0.56|1.21||||||2 mg/kg AUC0-inf Geometric Mean Ratio (GMR) = Birth to 27 days AUC0-inf Geometric Mean (GM) / 28 days to \< 3 months AUC0-inf GM.||1.21|0.56|
73928663|NCT03909165|147386956|OTHER||Geometric Mean Ratio (GMR)|1.41|||||TWO_SIDED|90.0|1.0|1.98||||||2 mg/kg AUC0-inf GMR = 28 days to \< 3 months AUC0-inf GM / 3 to \< 6 months AUC0-inf GM.||1.98|1.00|
73928664|NCT03909165|147386956|OTHER||Geometric Mean Ratio (GMR)|0.82|||||TWO_SIDED|90.0|0.6|1.11||||||2 mg/kg AUC0-inf GMR = 3 to \< 6 months AUC0-inf GM / 6 months to \< 2 years AUC0-inf GM.||1.11|0.60|
73928665|NCT03909165|147386956|OTHER||Geometric Mean Ratio (GMR)|1.23|||||TWO_SIDED|90.0|0.96|1.56||||||4 mg/kg AUC0-inf GMR = Birth to 27 days AUC0-inf GM / 28 days to \< 3 months AUC0-inf GM.||1.56|0.96|
73928666|NCT03909165|147386956|OTHER||Geometric Mean Ratio (GMR)|1.29|||||TWO_SIDED|90.0|1.03|1.62||||||4 mg/kg AUC0-inf GMR = 28 days to \< 3 months AUC0-inf GM / 3 to \< 6 months AUC0-inf GM.||1.62|1.03|
73928667|NCT03909165|147386956|OTHER||Geometric Mean Ratio (GMR)|0.89|||||TWO_SIDED|90.0|0.7|1.13||||||4 mg/kg AUC0-inf GMR = 3 to \< 6 months AUC0-inf GM / 6 months to \< 2 years AUC0-inf GM.||1.13|0.70|
73970207|NCT00986856|147480937|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.8||||0.007||95.0|1.5|109.6|||Cochran-Mantel-Haenszel|||||109.6|1.5|0.007
73970208|NCT00986856|147480938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_DEVIATION|2.0||0.008||95.0|-4.8|-0.8|||Regression, Linear|||||-0.8|-4.8|0.008
73928668|NCT03909165|147386957|OTHER||Geometric Mean Ratio (GMR)|0.91|||||TWO_SIDED|90.0|0.67|1.23||||||2 mg/kg AUC0-1hr GMR = Birth to 27 days AUC0-1hr GM / 28 days to \< 3 months AUC0-1hr GM.||1.23|0.67|
73928669|NCT03909165|147386957|OTHER||Geometric Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|0.92|1.69||||||2 mg/kg AUC0-1hr GMR = 28 days to \< 3 months AUC0-1hr GM / 3 to \< 6 months AUC0-1hr GM.||1.69|0.92|
73970209|NCT03020199|147480939|SUPERIORITY||Odds Ratio (OR)|16.8|||<|0.0001|TWO_SIDED|95.0|5.9|48.3|||Regression, Logistic||Logistic regression model with treatment as an explanatory variable and subset of significant covariates (including Baseline PASI score, age, BMI and their interaction terms with treatment) selected using forward selection method.|Week 52 PASI 90||48.3|5.9|<0.0001
73970210|NCT03020199|147480940|SUPERIORITY||Odds Ratio (OR)|0.8||||0.653|TWO_SIDED|95.0|0.3|2.1|||Regression, Logistic||Exact logistic regression method for Treatment group comparison, without using any covariates.|Week 104 PASI 90||2.1|0.3|0.6530
73970211|NCT05583578|147480942|SUPERIORITY|||||||0.012||||||The Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.012
73928670|NCT03909165|147386957|OTHER||Geometric Mean Ratio (GMR)|0.83|||||TWO_SIDED|90.0|0.64|1.08||||||2 mg/kg AUC0-1hr GMR = 3 to \< 6 months AUC0-1hr GM / 6 months to \< 2 years AUC0-1hr GM.||1.08|0.64|
73928671|NCT03909165|147386957|OTHER||Geometric Mean Ratio (GMR)|0.86|||||TWO_SIDED|90.0|0.7|1.06||||||4 mg/kg AUC0-1hr GMR = Birth to 27 days AUC0-1hr GM / 28 days to \< 3 months AUC0-1hr GM.||1.06|0.70|
73928672|NCT03909165|147386957|OTHER||Geometric Mean Ratio (GMR)|1.07|||||TWO_SIDED|90.0|0.89|1.29||||||4 mg/kg AUC0-1hr GMR = 28 days to \< 3 months AUC0-1hr GM / 3 to \< 6 months AUC0-1hr GM.||1.29|0.89|
73928673|NCT03909165|147386957|OTHER||Geometric Mean Ratio (GMR)|0.97|||||TWO_SIDED|90.0|0.8|1.17||||||4 mg/kg AUC0-1hr GMR = 3 to \< 6 months AUC0-1hr GM / 6 months to \< 2 years AUC0-1hr GM.||1.17|0.80|
73928674|NCT03909165|147386959|OTHER||Geometric Mean Ratio (GMR)|0.92|||||TWO_SIDED|90.0|0.61|1.4||||||2 mg/kg Cmax GMR = Birth to 27 days Cmax GM / 28 days to \< 3 months Cmax GM.||1.40|0.61|
73970212|NCT05583578|147480942|OTHER||Cohen's d (effect size)|0.98|||||TWO_SIDED||||||||Effect sizes greater than (d = 0.80) were considered large.|Post-intervention changes in walking speed||||
73970213|NCT05583578|147480943|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.39
73970214|NCT05583578|147480943|SUPERIORITY||Cohen's d (effect size)|0.31|||||TWO_SIDED||||||||Effect sizes ranging from 0.21 to 0.79 were considered moderate, anything ≥0.80 were considered large.|||||
73928675|NCT03909165|147386959|OTHER||Geometric Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.7|1.7||||||2 mg/kg Cmax GMR = 28 days to \< 3 months Cmax GM / 3 to \< 6 months Cmax GM.||1.70|0.70|
73928676|NCT03909165|147386959|OTHER||Geometric Mean Ratio (GMR)|0.92|||||TWO_SIDED|90.0|0.63|1.36||||||2 mg/kg Cmax GMR = 3 to \< 6 months Cmax GM / 6 months to \< 2 years Cmax GM.||1.36|0.63|
73928677|NCT03909165|147386959|OTHER||Geometric Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.7|1.26||||||4 mg/kg Cmax GMR = Birth to 27 days Cmax GM / 28 days to \< 3 months Cmax GM.||1.26|0.70|
73928678|NCT03909165|147386959|OTHER||Geometric Mean Ratio (GMR)|0.68|||||TWO_SIDED|90.0|0.52|0.89||||||4 mg/kg Cmax GMR = 28 days to \< 3 months Cmax GM / 3 to \< 6 months Cmax GM.||0.89|0.52|
73928679|NCT03909165|147386959|OTHER||Geometric Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.83|1.43||||||4 mg/kg AUC0-1hr GMR = 3 to \< 6 months Cmax GM / 6 months to \< 2 years Cmax GM.||1.43|0.83|
73928680|NCT03909165|147386964|SUPERIORITY||Hazard Ratio (HR)|2.4|||=|0.0002|TWO_SIDED|95.0|1.37|4.18||Two-sided p-value based on log-rank test stratified by neuromuscular blocking agent and age groups.|Log Rank|||The Hazard Ratio (HR) for the pairwise comparison of Sugammadex 2 mg/kg vs. Neostigmine + (Glycopyrrolate or Atropine) was based on a Cox regression model with Efron's method of tie handling with covariates of treatment, age (continuous) and stratified by neuromuscular blocking agent.||4.18|1.37|= 0.0002
73928681|NCT03909165|147386965|OTHER||Difference in Percentage|7.6|||||TWO_SIDED|95.0|-14.2|29.5||||||The difference in percentage of participants with an AE in sugammadex 2 mg/kg group versus the Neostigmine + (Glycopyrrolate or Atropine) group was based on the Miettinen and Nurminen method stratified by neuromuscular blocking agent and age group.||29.5|-14.2|
73928682|NCT03909165|147386965|OTHER||Difference in Percentage|5.9|||||TWO_SIDED|95.0|-13.5|26.7||||||The difference in percentage of participants with an AE in sugammadex 4 mg/kg group versus the Neostigmine + (Glycopyrrolate or Atropine) group was based on the Miettinen and Nurminen method stratified by neuromuscular blocking agent and age group.||26.7|-13.5|
73928683|NCT04609020|147386967|SUPERIORITY||Mean Difference (Final Values)|46.6|STANDARD_DEVIATION|23.61|<|0.0001|ONE_SIDED|97.5|40.58|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||40.58|<0.0001
73928684|NCT04609020|147386968|SUPERIORITY||Mean Difference (Final Values)|35.3|STANDARD_DEVIATION|22.36|<|0.0001|ONE_SIDED|97.5|29.61|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||29.61|<0.0001
73862729|NCT01541917|147271387|SUPERIORITY_OR_OTHER||Slope|0.053|STANDARD_ERROR_OF_MEAN|0.101||0.59|TWO_SIDED|95.0|-0.144|0.252|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.252|-.144|.59
73928685|NCT04609020|147386969|SUPERIORITY||Mean Difference (Final Values)|27.6|STANDARD_DEVIATION|23.23|<|0.0001|ONE_SIDED|97.5|21.5|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||21.50|<0.0001
73970215|NCT05201079|147480944|SUPERIORITY||Odds Ratio (OR)|2.395||||0.228|TWO_SIDED|97.79|0.54|10.624||Alpha: 0.0221|Regression, Logistic||Numerator: fidaxomicin; denominator: MBK-01|||10.624|0.540|0.228
73970216|NCT05201079|147480950|SUPERIORITY|||||||||||||||||Alpha value used: 0.0221|Statistical analysis using Odds Ratio cannot be performed because there are zero patients with bad progress in MBK-01 group.|||
73928686|NCT04609020|147386970|SUPERIORITY||Mean Difference (Final Values)|22.9|STANDARD_DEVIATION|20.56|<|0.0001|ONE_SIDED|97.5|17.65|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||17.65|<0.0001
73928687|NCT04609020|147386971|SUPERIORITY||Mean Difference (Final Values)|43.1|STANDARD_DEVIATION|22.25|<|0.0001|ONE_SIDED|97.5|37.48|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||37.48|<0.0001
73928688|NCT02107599|147386976|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Asymptotic Z-test|||||||0.0001
73928689|NCT02107599|147386977|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.0060
73928690|NCT02107599|147386977|SUPERIORITY_OR_OTHER|||||||0.1229|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.1229
73928691|NCT02107599|147386977|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.0260
73928692|NCT05583903|147387010|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73928693|NCT05583903|147387011|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.26
73928694|NCT05583903|147387012|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
73928695|NCT05583903|147387013|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
73928696|NCT05583903|147387014|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73928697|NCT05583903|147387015|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
73928698|NCT05583903|147387016|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
73970217|NCT05201079|147480951|SUPERIORITY||Score (logrank) test|1.25||||0.3|TWO_SIDED|||||Alpha: 0.0221|Regression, Cox|Degrees of freedom: 1||||||0.300
73970218|NCT05201079|147480953|SUPERIORITY||Score (logrank) test|0.02||||0.9|TWO_SIDED|||||Alpha: 0.0221|Regression, Cox|Degrees of freedom: 1||||||0.900
73970219|NCT05201079|147480964|SUPERIORITY|||||||0.749||||||Main effect of the Group for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 0.104.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.749
74029460|NCT03504774|147613446|OTHER||Mean Difference (Net)|1.1||||0.84|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 58||||0.84
73928699|NCT05583903|147387017|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
73928700|NCT05583903|147387018|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
73928701|NCT05583903|147387019|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
73928702|NCT05583903|147387020|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
73928703|NCT05583903|147387021|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
73928704|NCT05583903|147387022|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
73928705|NCT05583903|147387023|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
73928706|NCT05583903|147387024|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
73928707|NCT05179421|147387035|OTHER|NONMEM applies nonlinear mixed effects modeling to evaluate the relationship between predicted drug concentration after administration from known pharmacokinetics and a pharmacodynamic effect, in this case being a reduction in pain from sustained heat application.|||||<|0.05|||||||Mixed Models Analysis|||Pain scores over time will first be modeled using NONMEM with derived parameters of maximum effect (Emax) and doses to produce a 50% and 90% maximum drug effect (C50 and C90, respectively), the steepness of the dose response curve (γ), and the time to peak effect. Inter-subject variability (e.g., biological variability) will evaluate additive, proportional, and exponential models. Residual intrasubject variability (e.g., noise) will typically require an additive and multiplicative error model.||||<0.05
73928708|NCT03746522|147387038|OTHER|||||||0.0006||||||P-value was one-sided and compared with alpha = 0.025.|Rubin's Rule|||||||0.0006
73928709|NCT03746522|147387039|OTHER|||||||0.0005||||||p-value was one-sided and compared with alpha = 0.025|Rubin's Rule|||||||0.0005
73928710|NCT03746522|147387040|OTHER||||||<|0.0001||||||p-value was one-sided and compared with alpha=0.025.|Rubin's Rule|||||||<0.0001
73928711|NCT03746522|147387041|OTHER||||||<|0.0001||||||p-value was one-sided and compared with alpha = 0.025.|Rubin's Rule|||||||<0.0001
73928712|NCT01479621|147387042|SUPERIORITY_OR_OTHER|||||||0.0001||||||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed followed by pairwise comparisons of each Fp MDPI dose versus placebo.||||0.0001
73862730|NCT01541917|147271388|SUPERIORITY_OR_OTHER||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.1|0.14|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable||.14|.10|<.001
73928713|NCT01479621|147387042|SUPERIORITY_OR_OTHER||LSM difference|0.149||||0.0005|TWO_SIDED|95.0|0.066|0.233||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|mixed model for repeated measures|||This is the second analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.233|0.066|0.0005
73862731|NCT01541917|147271388|SUPERIORITY_OR_OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.63|TWO_SIDED|95.0|-0.05|0.03|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.03|-.05|.63
73928714|NCT01479621|147387042|SUPERIORITY_OR_OTHER||LSM difference|0.126||||0.0027|TWO_SIDED|95.0|0.044|0.208|||mixed model for repeated measures|||This is the third analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.208|0.044|0.0027
73928715|NCT01479621|147387042|SUPERIORITY_OR_OTHER||LSM difference|0.111||||0.0086|TWO_SIDED|95.0|0.028|0.194|||mixed model for repeated measures|||This is the fourth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.194|0.028|0.0086
73928716|NCT01479621|147387042|SUPERIORITY_OR_OTHER||LSM difference|0.052||||0.2227|TWO_SIDED|95.0|-0.032|0.136|||mixed model for repeated measures|||This is the fifth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.136|-0.032|0.2227
73928717|NCT01479621|147387043|SUPERIORITY_OR_OTHER|||||||0.0017||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).||||0.0017
73928718|NCT01479621|147387043|SUPERIORITY_OR_OTHER||LSM difference|18.29||||0.006|TWO_SIDED|95.0|5.28|31.29||Significance at 0.05|mixed model for repeated measures|||||31.29|5.28|0.0060
73928719|NCT01479621|147387043|SUPERIORITY_OR_OTHER||LSM difference|20.32||||0.0018|TWO_SIDED|95.0|7.61|33.03||Significance at 0.05|mixed model for repeated measures|||||33.03|7.61|0.0018
73928720|NCT01479621|147387043|SUPERIORITY_OR_OTHER||LSM difference|11.75||||0.0741|TWO_SIDED|95.0|-1.15|24.64||Significance at 0.05|mixed model for repeated measures|||||24.64|-1.15|0.0741
73928721|NCT01479621|147387043|SUPERIORITY_OR_OTHER||LSM difference|21.72||||0.0011|TWO_SIDED|95.0|8.73|34.72||Significance at 0.05|mixed model for repeated measures|||||34.72|8.73|0.0011
73928722|NCT01479621|147387044|SUPERIORITY_OR_OTHER|||||||0.0434||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).||||0.0434
73862732|NCT01541917|147271389|SUPERIORITY_OR_OTHER||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.02|TWO_SIDED|95.0|-0.18|-0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||-.01|-.18|.02
73928723|NCT01479621|147387044|SUPERIORITY_OR_OTHER||LSM difference|11.06||||0.0852|TWO_SIDED|95.0|-1.54|23.66||Significance at 0.05|mixed model for repeated measures|||||23.66|-1.54|0.0852
73928724|NCT01479621|147387044|SUPERIORITY_OR_OTHER||LSM difference|12.78||||0.0411|TWO_SIDED|95.0|0.52|25.04||Significance at 0.05|mixed model for repeated measures|||||25.04|0.52|0.0411
73928725|NCT01479621|147387044|SUPERIORITY_OR_OTHER||LSM difference|9.28||||0.1428|TWO_SIDED|95.0|-3.14|21.69||Significance at 0.05|mixed model for repeated measures|||||21.69|-3.14|0.1428
73928726|NCT01479621|147387044|SUPERIORITY_OR_OTHER||LSM difference|18.23||||0.0046|TWO_SIDED|95.0|5.64|30.82||Significance at 0.05|mixed model for repeated measures|||||30.82|5.64|0.0046
73928727|NCT01479621|147387045|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|2.76||||0.66685|TWO_SIDED|95.0|-10.07|15.6|||GEE|The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||15.60|-10.07|0.66685
73928728|NCT01479621|147387045|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|6.76||||0.26741|TWO_SIDED|95.0|-5.43|18.94||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||18.94|-5.43|0.26741
74029461|NCT03504774|147613446|OTHER||Mean Difference (Net)|0.7||||0.55|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from week 52 to week 58||||0.55
74029462|NCT03504774|147613447|OTHER||Mean Difference (Net)|2269.0||||0.23|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 52||||0.23
74029463|NCT03504774|147613447|OTHER||Mean Difference (Net)|1311.0||||0.12|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 58||||0.12
74029464|NCT03504774|147613447|OTHER||Mean Difference (Net)|958.0||||0.79|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from week 52 to week 58||||0.79
74029465|NCT03504774|147613447|OTHER||Mean Difference (Net)|347.0||||0.29|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 52||||0.29
74029466|NCT03504774|147613447|OTHER||Mean Difference (Net)|4364.0||||0.29|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 58||||0.29
74029467|NCT03504774|147613447|OTHER||Mean Difference (Net)|4017.0||||0.42|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from week 52 to week 58||||0.42
74029468|NCT00719576|147613468|SUPERIORITY|The Wilks lambda test statistic and associated single P value from the MANOVA model were used to test the statistical significance of the difference in the co-primary endpoint between MACI and microfracture.||||||0.001|||||||MANOVA|||The changes from Baseline to Week 104 in KOOS Pain and Function (SRA) scores (co-primary efficacy parameter) were analyzed with a multivariate analysis of variance (MANOVA) model, with the last observation carried forward (LOCF) method for handling missing data. Terms included in the model are treatment and center as class variables and baseline KOOS pain and Function (SRA) as continuous covariates.||||0.001
74029469|NCT00719576|147613469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.717||||||Differences between groups were tested using analysis of variance|ANOVA|ANOVA with terms for treatment and center||||||.717
73928729|NCT01479621|147387045|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|10.45||||0.09964|TWO_SIDED|95.0|-2.24|23.15||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||23.15|-2.24|0.09964
73928730|NCT01479621|147387045|SUPERIORITY_OR_OTHER||Slope|12.78||||0.03825|TWO_SIDED|95.0|0.44|25.11||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||25.11|0.44|0.03825
73928731|NCT01479621|147387046|SUPERIORITY_OR_OTHER|||||||0.2841||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.2841
73928732|NCT01479621|147387046|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||<0.0001
73928733|NCT01479621|147387046|SUPERIORITY_OR_OTHER|||||||0.0008||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.0008
73928734|NCT01479621|147387046|SUPERIORITY_OR_OTHER|||||||0.001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.0010
73928735|NCT01479621|147387052|SUPERIORITY_OR_OTHER||LSM difference|-0.114||||0.0058|TWO_SIDED|95.0|-0.195|-0.033||Significance at 0.05|mixed model for repeated measures|||||-0.033|-0.195|0.0058
73928736|NCT01479621|147387052|SUPERIORITY_OR_OTHER||LSM difference|0.034||||0.4083|TWO_SIDED|95.0|-0.046|0.114||Significance at 0.05|mixed model for repeated measures|||||0.114|-0.046|0.4083
73928737|NCT01479621|147387052|SUPERIORITY_OR_OTHER||LSM difference|0.011||||0.7882|TWO_SIDED|95.0|-0.068|0.089||Significance at 0.05|mixed model for repeated measures|||||0.089|-0.068|0.7882
73928738|NCT01479621|147387052|SUPERIORITY_OR_OTHER||LSM difference|-0.002||||0.9586|TWO_SIDED|95.0|-0.082|0.078||Significance at 0.05|mixed model for repeated measures|||||0.078|-0.082|0.9586
73928739|NCT01479621|147387052|SUPERIORITY_OR_OTHER||LSM difference|-0.062||||0.1306|TWO_SIDED|95.0|-0.143|0.018||Significance at 0.05|mixed model for repeated measures|||||0.018|-0.143|0.1306
73928740|NCT01479621|147387053|SUPERIORITY_OR_OTHER||LSM difference|-17.66||||0.0068|TWO_SIDED|95.0|-30.43|-4.89||Significance at 0.05|mixed model for repeated measures|||||-4.89|-30.43|0.0068
73928741|NCT01479621|147387053|SUPERIORITY_OR_OTHER||LSM difference|0.69||||0.9135|TWO_SIDED|95.0|-11.84|13.23||Significance at 0.05|mixed model for repeated measures|||||13.23|-11.84|0.9135
73928742|NCT01479621|147387053|SUPERIORITY_OR_OTHER||LSM difference|2.67||||0.6689|TWO_SIDED|95.0|-9.58|14.92||Significance at 0.05|mixed model for repeated measures|||||14.92|-9.58|0.6689
73928743|NCT01479621|147387053|SUPERIORITY_OR_OTHER||LSM difference|-5.69||||0.3691|TWO_SIDED|95.0|-18.12|6.74||Significance at 0.05|mixed model for repeated measures|||||6.74|-18.12|0.3691
73928744|NCT01479621|147387053|SUPERIORITY_OR_OTHER||LSM difference|4.24||||0.5072|TWO_SIDED|95.0|-8.31|16.78||Significance at 0.05|mixed model for repeated measures|||||16.78|-8.31|0.5072
73928745|NCT01479621|147387054|SUPERIORITY_OR_OTHER||LSM difference|-15.26||||0.0158|TWO_SIDED|95.0|-27.63|-2.88||Significance at 0.05|mixed model for repeated measures|||||-2.88|-27.63|0.0158
73928746|NCT01479621|147387054|SUPERIORITY_OR_OTHER||LSM difference|-4.48||||0.4709|TWO_SIDED|95.0|-16.69|7.721||Significance at 0.05|mixed model for repeated measures|||||7.721|-16.69|0.4709
73928747|NCT01479621|147387054|SUPERIORITY_OR_OTHER||LSM difference|-2.68||||0.6572|TWO_SIDED|95.0|-14.55|9.19||Significance at 0.05|mixed model for repeated measures|||||9.19|-14.55|0.6572
73928748|NCT01479621|147387054|SUPERIORITY_OR_OTHER||LSM difference|-5.98||||0.3292|TWO_SIDED|95.0|-18.01|6.05||Significance at 0.05|mixed model for repeated measures|||||6.05|-18.01|0.3292
73928749|NCT01479621|147387054|SUPERIORITY_OR_OTHER||LSM difference|3.05||||0.6237|TWO_SIDED|95.0|-9.16|15.26||Significance at 0.05|mixed model for repeated measures|||||15.26|-9.16|0.6237
73928750|NCT05422053|147387065|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of Control-IQ Use (13 Weeks) compared to Control-IQ Start||||<0.001
73928751|NCT02439775|147387088|SUPERIORITY|||||||0.1194||||||p\<0.05 required for significance|ANCOVA|||||||0.1194
73928752|NCT00739752|147387102|SUPERIORITY||Risk Ratio (RR)|0.99|||=|0.885|TWO_SIDED|95.0|0.88|1.12|||Regression, Poisson|||The two gain-framed groups were compared to the two loss-framed groups using poisson regression.||1.12|.88|=.885
73928753|NCT00739752|147387102|SUPERIORITY||Risk Ratio (RR)|1.17|||<|0.01|TWO_SIDED|95.0|1.06|1.31|||Regression, Poisson|||Groups receiving any framed interventions (gain-framed or loss-framed) were compared to those in the two non-framed control groups.||1.31|1.06|<.01
73928754|NCT00739752|147387102|SUPERIORITY||Risk Ratio (RR)|1.16|||<|0.01|TWO_SIDED|95.0|1.05|1.28|||Regression, Poisson|||The 3 vaccine-recommended groups were compared with the 3 vaccine-offered groups using poisson regression.||1.28|1.05|<.01
73928755|NCT03925727|147387129|SUPERIORITY||Mean Difference (Net)|1.4||||0.5533|TWO_SIDED|95.0|-3.2|6.0|||ANCOVA|||||6|-3.2|0.5533
73928756|NCT03925727|147387130|SUPERIORITY||Mean Difference (Net)|-0.6||||0.0192|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||||-0.1|-1.1|0.0192
73928757|NCT01393743|147387143|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-30.81||||0.0001|TWO_SIDED|95.0|-45.49|-15.244||The P-value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.||-15.244|-45.49|0.0001
73928758|NCT01393743|147387144|SUPERIORITY_OR_OTHER|||||||0.0019||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel|||||||0.0019
73928759|NCT01393743|147387146|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.45||||0.0018|TWO_SIDED|95.0|-40.668|-8.518||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.||-8.518|-40.668|0.0018
74029470|NCT00719576|147613470|SUPERIORITY|||||||0.92|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Row Mean Score Chi-Square||Differences between groups were tested by the Cochran-Mantel-Haenszel row mean score chi-squared test for defect fill.||||.920
73862733|NCT01541917|147271389|SUPERIORITY_OR_OTHER||Slope|-0.009|STANDARD_ERROR_OF_MEAN|0.084||0.91|TWO_SIDED|95.0|-0.174|0.155|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.155|-.174|.91
73862734|NCT01541917|147271390|SUPERIORITY_OR_OTHER||Slope|0.0316|STANDARD_ERROR_OF_MEAN|0.004|<|0.001|TWO_SIDED|95.0|0.02|0.04|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable||.04|.02|<.001
73862735|NCT01541917|147271390|SUPERIORITY_OR_OTHER||Slope|-0.004|STANDARD_ERROR_OF_MEAN|0.008||0.67|TWO_SIDED|95.0|-0.02|0.013|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.013|-.02|.67
73928760|NCT01393743|147387147|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.25||||0.3478|TWO_SIDED|95.0|-53.054|26.989||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|Median Difference to Placebo for Absence Seizures||26.989|-53.054|0.3478
73928761|NCT01393743|147387147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.87||||0.61|TWO_SIDED|95.0|-15.338|59.938|||ANCOVA|||Median Difference to Placebo for Myoclonic Seizure||59.938|-15.338|0.61
73928762|NCT01393743|147387148|SUPERIORITY_OR_OTHER|||||||0.1826||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel|||||||0.1826
73928763|NCT01393743|147387149|SUPERIORITY_OR_OTHER|||||||0.4653|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Absence Seizures||||0.4653
73928764|NCT01393743|147387149|SUPERIORITY_OR_OTHER|||||||0.3694|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Myoclonic Seizures||||0.3694
73928765|NCT02321462|147387164|NON_INFERIORITY|Non-inferiority would be demonstrated if the lower limit of the 95% confidence intervals (CI) of the difference was higher than the predefined noninferiority margin (-15%).|Adjusted difference|-0.46|||||TWO_SIDED|95.0|-4.22|3.29|||||To investigate noninferiority of Eziclen compared to Fortrans®, the adjusted difference between these 2 groups was calculated with 95% CI of the adjusted difference.|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status (No IBD, IBD) was used.||3.29|-4.22|
73928766|NCT02321462|147387165|SUPERIORITY||Adjusted difference|0.15|||=|0.0249|TWO_SIDED|95.0|0.02|0.28|||ANOVA|A 2-way analysis of variance model (ANOVA) with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score.||0.28|0.02|=0.0249
73928767|NCT02321462|147387165|SUPERIORITY||Adjusted difference|0.11|||=|0.0382|TWO_SIDED|95.0|0.01|0.22|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score.||0.22|0.01|=0.0382
73928768|NCT02321462|147387165|SUPERIORITY||Adjusted difference|0.06|||=|0.2538|TWO_SIDED|95.0|-0.04|0.16|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Left Colon BBPS Score.||0.16|-0.04|=0.2538
73928769|NCT02321462|147387165|SUPERIORITY||Adjusted difference|0.33|||=|0.0256|TWO_SIDED|95.0|0.04|0.62|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Global BBPS Score.||0.62|0.04|=0.0256
73928770|NCT02321462|147387166|SUPERIORITY||Adjusted difference|0.11|||=|0.084|TWO_SIDED|95.0|-0.02|0.24|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score (per protocol population).||0.24|-0.02|=0.0840
73928771|NCT02321462|147387166|SUPERIORITY||Treatment difference|0.08|||=|0.132|TWO_SIDED|95.0|-0.02|0.18|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score (per protocol population).||0.18|-0.02|=0.1320
73970220|NCT05201079|147480964|SUPERIORITY|||||||0.62||||||Main effect of the Visit for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 0.249.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.620
73970221|NCT05201079|147480964|SUPERIORITY|||||||0.16||||||Main effect of the Group x Visit interaction for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 2.024.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.160
73862736|NCT01541917|147271391|SUPERIORITY_OR_OTHER||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.58|TWO_SIDED|95.0|-0.01|0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||.01|-.01|.58
73928772|NCT02321462|147387167|SUPERIORITY||Adjusted difference|-6.94|||=|0.2199|TWO_SIDED|95.0|-17.53|3.64|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of polyps.||3.64|-17.53|=0.2199
73928773|NCT02321462|147387167|SUPERIORITY||Adjusted difference|1.87|||=|0.6325|TWO_SIDED|95.0|-6.25|9.99|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of adenomas.||9.99|-6.25|=0.6325
73928774|NCT02321462|147387167|SUPERIORITY||Adjusted difference|-1.55|||=|0.7086|TWO_SIDED|95.0|-9.64|6.54|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of other lesions.||6.54|-9.64|=0.7086
73862737|NCT01541917|147271391|SUPERIORITY_OR_OTHER||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.007||0.49|TWO_SIDED|95.0|-0.009|0.018|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.018|-.009|.49
73862738|NCT00121641|147271392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.33||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.33|-0.90|<.0001
73862739|NCT00121641|147271392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.93|-0.36||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.36|-0.93|<.0001
73928775|NCT02321462|147387168|SUPERIORITY||Adjusted difference|0.01|||=|0.9927|TWO_SIDED|95.0|-3.12|3.14|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||||3.14|-3.12|=0.9927
73928776|NCT02321462|147387169|SUPERIORITY||Adjusted difference|-0.3|||=|0.7039|TWO_SIDED|95.0|-1.88|1.27|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||||1.27|-1.88|=0.7039
73928777|NCT02321462|147387170|SUPERIORITY||Adjusted difference|0.1|||=|0.1891|TWO_SIDED|95.0|-0.05|0.25|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||||0.25|-0.05|=0.1891
73928778|NCT02321462|147387171|SUPERIORITY||Adjusted difference|13.35|||=|0.0011|TWO_SIDED|95.0|6.37|20.32|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||||20.32|6.37|=0.0011
73928779|NCT05409235|147387184|SUPERIORITY||difference in percentage of participants|-1.064||||0.573|TWO_SIDED|90.0|-10.578|8.449|||Mantel Haenszel|MH test is adjusted for the randomization stratification factor (Screening DRSS score 47 or 53 or 61B).|A single imputation (non-response) when applying composite variable strategy. MI based for missing data at Week 24, assuming MAR when applying hypothetical strategy. Kept in the analysis when applying treatment policy strategy.|The study was powered to provide a 90% probability to detect a 20% difference between each treatment arm and the combined vehicle control.||8.449|-10.578|0.5730
73928780|NCT05409235|147387184|SUPERIORITY||difference in percentage of participants|-1.152||||0.575|TWO_SIDED|90.0|-11.178|8.874|||Mantel Haenszel|||||8.874|-11.178|0.5750
73928781|NCT05409235|147387185|SUPERIORITY||difference in percentage of participants|3.119||||0.7276|TWO_SIDED|90.0|-5.314|11.592|||Mantel Haenszel|||||11.592|-5.314|0.7276
73928782|NCT05409235|147387185|SUPERIORITY||difference in percentage of participants|5.779||||0.8492|TWO_SIDED|90.0|-3.424|14.982|||Mantel Haenszel|||||14.982|-3.424|0.8492
73928783|NCT05409235|147387186|SUPERIORITY||difference in percentage of participants|-1.863||||0.3097|TWO_SIDED|90.0|-8.036|4.309|||Mantel Haenszel|||||4.309|-8.036|0.3097
73928784|NCT05409235|147387186|SUPERIORITY||difference in percentage of participants|-1.596||||0.3414|TWO_SIDED|90.0|-8.021|4.829|||Mantel Haenszel|||||4.829|-8.021|0.3414
73970222|NCT05201079|147480964|SUPERIORITY|||||||0.614||||||Main effect of the Group for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 0.257.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.614
73928785|NCT05409235|147387187|SUPERIORITY||Cox Proportional Hazard|0.899||||0.397|TWO_SIDED|90.0|0.4378|1.8467|||Log Rank|||||1.8467|0.4378|0.397
73862740|NCT00121641|147271392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.02|-0.44||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.44|-1.02|<.0001
73970223|NCT05201079|147480964|SUPERIORITY|||||||0.007||||||Main effect of the Visit for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 7.705. Effect size = 0.046.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.007
73928786|NCT05409235|147387187|SUPERIORITY||Cox Proportional Hazard|1.113||||0.605|TWO_SIDED|90.0|0.5596|2.2117|||Log Rank|||||2.2117|0.5596|0.605
73928787|NCT05409235|147387188|SUPERIORITY||difference in percentage of participants|-10.622||||0.0619|TWO_SIDED|90.0|-21.972|0.728|||Mantel Haenszel|||||0.728|-21.972|0.0619
73928788|NCT05409235|147387188|SUPERIORITY||difference in percentage of participants|-4.942||||0.2483|TWO_SIDED|90.0|-16.897|7.013|||Mantel Haenszel|||||7.013|-16.897|0.2483
73928789|NCT05409235|147387189|SUPERIORITY||Cox Proportional Hazard|0.807||||0.237|TWO_SIDED|90.0|0.4675|1.392|||Log Rank|||||1.3920|0.4675|0.237
73928790|NCT05409235|147387189|SUPERIORITY||Cox Proportional Hazard|1.279||||0.766|TWO_SIDED|90.0|0.7795|2.0981|||Log Rank|||||2.0981|0.7795|0.766
73928791|NCT05409235|147387190|SUPERIORITY||difference in percentage of participants|-6.389||||0.2022|TWO_SIDED|90.0|-18.994|6.215|||Mantel Haenszel|||||6.215|-18.994|0.2022
73928792|NCT05409235|147387190|SUPERIORITY||difference in percentage of participants|-1.043||||0.4476|TWO_SIDED|90.0|-14.07|11.984|||Mantel Haenszel|||||11.984|-14.070|0.4476
73928793|NCT05409235|147387191|SUPERIORITY||Hazard Ratio (HR)|0.843||||0.268|TWO_SIDED|90.0|0.533|1.334||log-rank test stratified by randomization stratification factor|Log Rank|||||1.334|0.533|0.268
73928794|NCT05409235|147387191|SUPERIORITY||Hazard Ratio (HR)|1.145||||0.304|TWO_SIDED|90.0|0.738|1.775|||Log Rank|||||1.775|0.738|0.304
73928795|NCT05409235|147387192|SUPERIORITY||Odds Ratio (OR)|1.102||||0.428|TWO_SIDED|90.0|0.4573|2.657|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||2.6570|0.4573|0.428
73970224|NCT05201079|147480964|SUPERIORITY|||||||0.718||||||Main effect of the Group x Visit interaction for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 0.132.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.718
73970225|NCT05201079|147480964|SUPERIORITY|||||||0.494||||||Main effect of the Group for the General Health area of the SF-36 questionnaire. F statistic (1,56) = 0.474.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.494
73970226|NCT05201079|147480964|SUPERIORITY|||||||0.339||||||Main effect of the Visit for the General Health area of the SF-36 questionnaire. F statistic (1,56) = 0.932.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.339
73970227|NCT05201079|147480964|SUPERIORITY|||||||0.38||||||Main effect of the Group x Visit interaction for the General health area of the SF-36 questionnaire. F statistic (1,56) = 0.783.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.380
73970228|NCT05201079|147480964|SUPERIORITY|||||||0.79||||||Main effect of the Group for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 0.072|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.790
73970229|NCT05201079|147480964|SUPERIORITY|||||||0.498||||||Main effect of the Visit for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 0.465.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.498
73970230|NCT05201079|147480964|SUPERIORITY|||||||0.023||||||Main effect of the Group x Visit interaction for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 5.490.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.023
73970231|NCT05201079|147480964|SUPERIORITY|||||||0.553||||||Main effect of the Group for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.356.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.553
73970232|NCT05201079|147480964|SUPERIORITY|||||||0.718||||||Main effect of the Visit for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.132.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.718
73970233|NCT05201079|147480964|SUPERIORITY|||||||0.574||||||Main effect of the Group x Visit interaction for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.319.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.574
73970234|NCT05201079|147480964|SUPERIORITY|||||||0.49||||||Main effect of the Group for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 0.482.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.490
73970235|NCT05201079|147480964|SUPERIORITY|||||||0.032||||||Main effect of the Visit for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 4.850|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.032
73970236|NCT05201079|147480964|SUPERIORITY|||||||0.145||||||Main effect of the Group x Visit interaction for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 2.181.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.145
73970237|NCT05201079|147480964|SUPERIORITY|||||||0.467||||||Main effect of the Group for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 0.535.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.467
73970238|NCT05201079|147480964|SUPERIORITY|||||||0.1||||||Main effect of the Visit for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 2.795|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.100
73970239|NCT05201079|147480964|SUPERIORITY|||||||0.89||||||Main effect of the Group x Visit interaction for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 0.019.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.890
73970240|NCT05201079|147480964|SUPERIORITY|||||||0.742||||||Main effect of the Group for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 0.109.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.742
73970241|NCT05201079|147480964|SUPERIORITY||||||<|0.001||||||Main effect of the Visit for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 21.912. Effect size = 0.109.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||<0.001
73970242|NCT05201079|147480964|SUPERIORITY|||||||0.089||||||Main effect of the Group x Visit interaction for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 2.986.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.089
73970243|NCT04752709|147480965|OTHER||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.0001
73970244|NCT05692960|147480981|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|FSFI Total, HRI Cohen's d|1.37|||||TWO_SIDED|95.0|0.62|2.1||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for FSFI total, FSFI lubrication, FSFI pain, and FSFI desire subscales. Means and 95% confidence intervals were also calculated.||2.10|.62|
73970245|NCT05692960|147480981|SUPERIORITY||FSFI Total, VVA Cohen's d|1.63|||||TWO_SIDED|95.0|0.86|2.37||||||||2.37|.86|
73970246|NCT05692960|147480981|SUPERIORITY||FSFI Lubrication, HRI Cohen's d|1.2|||||TWO_SIDED|95.0|0.49|1.87||||||||1.87|.49|
73970247|NCT05692960|147480981|SUPERIORITY||FSFI Lubrication, VVA Cohen's d|1.85|||||TWO_SIDED|95.0|1.02|2.66||||||||2.66|1.02|
73970248|NCT05692960|147480981|SUPERIORITY||FSFI Pain, HRI Cohen's d|0.77|||||TWO_SIDED|95.0|0.16|1.36||||||||1.36|.16|
73970249|NCT05692960|147480981|SUPERIORITY||FSFI Pain, VVA Cohen's d|0.82|||||TWO_SIDED|95.0|0.24|1.38||||||||1.38|.24|
73970250|NCT05692960|147480981|SUPERIORITY||FSFI Desire, HRI Cohen's d|1.15|||||TWO_SIDED|95.0|0.46|1.82||||||||1.82|.46|
73970251|NCT05692960|147480981|SUPERIORITY||FSFI Desire, VVA Cohen's d|1.21|||||TWO_SIDED|95.0|0.55|1.86||||||||1.86|.55|
73970252|NCT05692960|147480982|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|BITS, HRI Cohen's d|1.0|||||TWO_SIDED|95.0|0.34|1.63||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for the BITS. Means and 95% confidence intervals were also calculated.||1.63|.34|
73970253|NCT05692960|147480982|SUPERIORITY||BITS, VVA Cohen's d|0.5|||||TWO_SIDED|95.0|0.03|1.01||||||||1.01|.03|
73970254|NCT05692960|147480983|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|PROMIS Interest, HRI Cohen's d|1.1|||||TWO_SIDED|95.0|0.41|1.75||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-test for PROMIS interest, lubrication and satisfaction subscales. Means and 95% confidence intervals were also calculated.||1.75|.41|
73970255|NCT05692960|147480983|SUPERIORITY||PROMIS Interest, VVA Cohen's d|0.64|||||TWO_SIDED|95.0|0.09|1.18||||||||1.18|.09|
73970256|NCT05692960|147480983|SUPERIORITY||PROMIS Satisfaction, HRI Cohen's d|1.19|||||TWO_SIDED|95.0|0.45|1.89||||||||1.89|.45|
73970257|NCT05692960|147480983|SUPERIORITY||PROMIS Satisfaction, VVA Cohen's d|0.8|||||TWO_SIDED|95.0|0.13|1.44||||||||1.44|.13|
73970258|NCT05692960|147480983|SUPERIORITY||PROMIS Lubrication, HRI Cohen's d|1.79|||||TWO_SIDED|95.0|0.88|2.67||||||||2.67|.88|
73970259|NCT05692960|147480983|SUPERIORITY||PROMIS Lubrication, VVA Cohen's d|1.63|||||TWO_SIDED|95.0|0.74|2.5||||||||2.50|.74|
73970260|NCT05386030|147480984|NON_INFERIORITY|The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB\> d0 where, pA is the response rate for saypha® VOLUME Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested based on Farrington-Manning-statistics with a one-sided type I error rate level of 0.025.|||||<|0.0001||||||Confirmatory testing will be performed in a hierarchical ordering: First analysis will be performed on the per protocol dataset, and if the corresponding p-value is below 0.025, the analysis will be performed on the full analysis dataset.|Farrington-Manning test|||||||<0.0001
73970261|NCT05386030|147480985|NON_INFERIORITY|The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB\> d0 where, pA is the response rate for saypha® VOLUME Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested based on Farrington-Manning-statistics with a one-sided type I error rate level of 0.025.|||||<|0.0001||||||Confirmatory testing will be performed in a hierarchical ordering: First analysis will be performed on the per protocol dataset, and if the corresponding p-value is below 0.025, the analysis will be performed on the full analysis dataset.|Farrington-Manning test|||||||<0.0001
73970262|NCT04719832|147481007|SUPERIORITY|Analysis performed using a negative binomial model with covariates of treatment, exacerbation history (2, 3, 4+), baseline inhaled CS dose (medium, high), geographical region, baseline percent predicted Forced Expiratory Volume in one second (FEV1), and offset of log (total time in the study in years).|Rate Ratio|0.42|||<|0.001|TWO_SIDED|95.0|0.3|0.59|||Negative binomial distribution|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.||0.59|0.30|< 0.001
73970263|NCT04719832|147481008|SUPERIORITY||Difference in Least Square Means|-3.36|||=|0.08|TWO_SIDED|95.0|-7.11|0.39|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline SGRQ total score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline SGRQ total score and visit by treatment group||0.39|-7.11|= 0.080
73970264|NCT04719832|147481009|SUPERIORITY||Difference in Least Square Means|-0.04|||=|0.69|TWO_SIDED|95.0|-0.27|0.18|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.||0.18|-0.27|= 0.690
73970265|NCT04719832|147481010|SUPERIORITY||Difference in Least Square Means|-0.001|||=|0.991|TWO_SIDED|95.0|-0.089|0.088|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.||0.088|-0.089|= 0.991
73970266|NCT04719832|147481011|SUPERIORITY||Difference in Least Square Means|-0.09|||=|0.65|TWO_SIDED|95.0|-0.5|0.31|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.||0.31|-0.50|= 0.650
73928796|NCT05409235|147387192|SUPERIORITY||Odds Ratio (OR)|1.119||||0.419|TWO_SIDED|90.0|0.45|2.7846|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||2.7846|0.4500|0.419
73928797|NCT05409235|147387193|SUPERIORITY||difference in percentage of participants|-1.544||||0.6716|TWO_SIDED|90.0|-7.26|4.172|||Mantel Haenszel|||||4.172|-7.260|0.6716
73928798|NCT05409235|147387193|SUPERIORITY||difference in percentage of participants|-3.412||||0.8414|TWO_SIDED|90.0|-9.025|2.2|||Mantel Haenszel|||||2.200|-9.025|0.8414
73928799|NCT05409235|147387194|SUPERIORITY||Mean Difference (Net)|-0.5325||||0.647|TWO_SIDED|90.0|-2.8478|1.7827|||ANCOVA|||||1.7827|-2.8478|0.647
73928800|NCT05409235|147387194|SUPERIORITY||Mean Difference (Net)|-2.2849||||0.945|TWO_SIDED|90.0|-4.6356|0.0658|||ANCOVA|||||0.0658|-4.6356|0.945
74029471|NCT00719576|147613471|SUPERIORITY|||||||0.016||||||KOOS Response Rate: a participant is regarded as a responder for KOOS if a 10-point improvement in both KOOS Pain and Function (SRA) scores was achieved with respect to Baseline. Otherwise, the patient is regarded as a nonresponder.|Cochran-Mantel-Haenszel|p-value was calculated for response categories 'Responded' and 'Not responded' using a Cochran-Mantel-Haenszel χ2 Test stratified by Center||Differences between groups were tested by the Cochran-Mantel-Haenszel chi-squared test stratified by center for responders.||||0.016
74029472|NCT00719576|147613473|SUPERIORITY||||||<|0.001||||||KOOS activities of daily living p-value \<0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||<0.001
74029473|NCT00719576|147613473|SUPERIORITY|||||||0.029||||||KOOS knee-related quality of life p-value 0.029|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||0.029
73928801|NCT05409235|147387195|SUPERIORITY||Odds Ratio (OR)|1.108||||0.367|TWO_SIDED|90.0|0.6722|1.8276|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||1.8276|0.6722|0.367
73928802|NCT05409235|147387195|SUPERIORITY||Odds Ratio (OR)|0.717||||0.857|TWO_SIDED|90.0|0.4295|1.1981|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||1.1981|0.4295|0.857
73928803|NCT05409235|147387196|SUPERIORITY||Mean Difference (Net)|4.1531||||0.437|TWO_SIDED|90.0|-38.793|47.0991|||ANCOVA|||||47.0991|-38.7930|0.437
73928804|NCT05409235|147387196|SUPERIORITY||Mean Difference (Net)|-16.2461||||0.733|TWO_SIDED|90.0|-59.2538|26.7616|||ANCOVA|||||26.7616|-59.2538|0.733
73928805|NCT05409235|147387197|SUPERIORITY||Mean Difference (Net)|4.0634||||0.77|TWO_SIDED|90.0|-4.9712|13.098|||ANCOVA|||||13.0980|-4.9712|0.770
73928806|NCT05409235|147387197|SUPERIORITY||Mean Difference (Net)|-1.0507||||0.424|TWO_SIDED|90.0|-10.1046|8.0032|||ANCOVA|||||8.0032|-10.1046|0.424
73928807|NCT05409235|147387198|SUPERIORITY||Mean Difference (Net)|0.0205||||0.606|TWO_SIDED|90.0|-0.1043|0.1452|||ANCOVA|||||0.1452|-0.1043|0.606
73928808|NCT05409235|147387198|SUPERIORITY||Mean Difference (Net)|0.0083||||0.544|TWO_SIDED|90.0|-0.1161|0.1326|||ANCOVA|||||0.1326|-0.1161|0.544
73928809|NCT05409235|147387199|SUPERIORITY||difference in percentage of participants|-1.544||||0.406|TWO_SIDED|90.0|-12.247|9.158|||Mantel Haenszel|||||9.158|-12.247|0.406
73928810|NCT05409235|147387199|SUPERIORITY||difference in percentage of participants|1.763||||0.605|TWO_SIDED|90.0|-9.114|12.64|||Mantel Haenszel|||||12.640|-9.114|0.605
73928811|NCT05409235|147387200|SUPERIORITY||Hazard Ratio (HR)|0.916||||0.404|TWO_SIDED|90.0|0.5068|1.6556|||Log Rank|||||1.6556|0.5068|0.404
73928812|NCT05409235|147387200|SUPERIORITY||Hazard Ratio (HR)|1.128||||0.624|TWO_SIDED|90.0|0.6399|1.9868|||Log Rank|||||1.9868|0.6399|0.624
73928813|NCT05409235|147387201|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.478|TWO_SIDED|90.0|0.2473|3.6295|||Log Rank|Comparisons are made using the log-rank test stratified by randomization stratification factor.||||3.6295|0.2473|0.478
73928814|NCT05409235|147387201|SUPERIORITY||Hazard Ratio (HR)|1.296||||0.631|TWO_SIDED|90.0|0.3688|4.5512|||Log Rank|Comparisons are made using the log-rank test stratified by randomization stratification factor||||4.5512|0.3688|0.631
73928815|NCT05409235|147387202|SUPERIORITY||difference in percentage of participants|-13.7727||||0.045|TWO_SIDED|90.0|-27.1319|-0.4134|||Mantel Haenszel|||||-0.4134|-27.1319|0.0450
73928816|NCT05409235|147387202|SUPERIORITY||difference in percentage of participants|-3.8234||||0.3304|TWO_SIDED|90.0|-18.1549|10.5081|||Mantel Haenszel|||||10.5081|-18.1549|0.3304
73928817|NCT05409235|147387203|SUPERIORITY||difference in percentage of participants|-14.8877||||0.0275|TWO_SIDED|90.0|-27.6462|-2.1293|||Mantel Haenszel|||||-2.1293|-27.6462|0.0275
73928818|NCT05409235|147387203|SUPERIORITY||difference in percentage of participants|-7.5535||||0.179|TWO_SIDED|90.0|-21.0688|5.9617|||Mantel Haenszel|||||5.9617|-21.0688|0.1790
73928819|NCT01282424|147387219|SUPERIORITY||||||<|0.0001||||||The null hypothesis is ≤ 20%.|Exact binomial test|||||||< 0.0001
73928820|NCT04976530|147387234|SUPERIORITY||win ratio|1.07||||0.748|TWO_SIDED|95.0|0.72|1.58|||Finkelstein Schoenfeld test|||||1.58|0.72|0.748
73928821|NCT04976530|147387235|SUPERIORITY||win ratio|1.33||||0.202|TWO_SIDED|95.0|0.86|2.04|||Finkelstein Schoenfeld test|||||2.04|0.86|0.202
73928822|NCT04976530|147387236|SUPERIORITY||win ratio|1.17||||0.451|TWO_SIDED|95.0|0.79|1.73|||Finkelstein Schoenfeld test|||||1.73|0.79|0.451
73928823|NCT04976530|147387237|SUPERIORITY||win ratio|1.59||||0.041|TWO_SIDED|95.0|1.02|2.46|||Finkelstein Schoenfeld test|||||2.46|1.02|0.041
73928824|NCT04976530|147387238|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
73928825|NCT04976530|147387239|SUPERIORITY|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||||||0.079
73928826|NCT04976530|147387240|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|||||||0.427
73928827|NCT04976530|147387241|SUPERIORITY|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||||||0.042
73928828|NCT03750903|147387246|OTHER|||||||0.05|||||||ANOVA|||||||0.05
73928829|NCT00773175|147387287|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.5||||0.5064|TWO_SIDED|95.0|-221.2|86.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||86.2|-221.2|0.5064
74088047|NCT02709486|147729970|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.05|<.0001
74088048|NCT02709486|147729970|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.09|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.44|-1.09|<.0001
73928830|NCT00773175|147387287|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.0||||0.0325|TWO_SIDED|95.0|-54.6|102.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||102.7|-54.6|0.0325
73928831|NCT00773175|147387288|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-174.7||||0.8915|TWO_SIDED|95.0|-340.3|-9.1||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||-9.1|-340.3|0.8915
73928832|NCT00773175|147387288|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-58.6||||0.5469|TWO_SIDED|95.0|-137.5|20.3||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||20.3|-137.5|0.5469
73928833|NCT00773175|147387290|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.0||||0.5035|TWO_SIDED|95.0|-220.6|86.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||86.7|-220.6|0.5035
74088049|NCT02709486|147729970|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.17||0.0005|TWO_SIDED|95.0|-0.93|-0.26|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.93|0.0005
73928834|NCT00773175|147387290|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.6||||0.0314|TWO_SIDED|95.0|-54.0|103.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||103.2|-54.0|0.0314
73928835|NCT00773175|147387294|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||TWO_SIDED|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||9.4|-69.5|
73928836|NCT00773175|147387294|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||TWO_SIDED|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||-3.1|-77.3|
73928837|NCT00773175|147387295|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||TWO_SIDED|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||9.4|-69.5|
73970267|NCT04719832|147481012|SUPERIORITY||Difference in Least Square Means|-0.08|||=|0.647|TWO_SIDED|95.0|-0.42|0.26|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.||0.26|-0.42|= 0.647
73970268|NCT05228457|147481014|SUPERIORITY|13 participants were randomized to receive active TMS, and 13 were randomized to receive sham TMS. 1 participant from each group withdrew, resulting in their exclusion from the analysis. Therefore, 24 participants were randomized to active (n = 12) or sham (n = 12) aiTBS groups. The analysis examined MADRS scores measured at baseline and post-treatment. A priori hypotheses were that active aiTBS would demonstrate measurable differences in MADRS scores compared to the sham group.|Mean Difference (Final Values)|-14.8|||<|0.001|TWO_SIDED|95.0|-19.94|-9.56|||t-test, 2 sided||The primary outcome was the between-group (Active vs Sham) difference in MADRS scores at the end of the treatment period. Results, including mean scores, standard deviations, confidence intervals, and p-value for the between-group comparisons.|||-9.56|-19.94|<0.001
73970269|NCT05228457|147481015|SUPERIORITY||Z-transformed Pearson's r values|-0.014||||0.04|TWO_SIDED||||||t-test, 2 sided|||Z-transformed Pearson's r values of average voxel-wise connectivity within the DMN||||0.04
73862741|NCT00121641|147271393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.6|STANDARD_ERROR_OF_MEAN|5.53||0.0002|TWO_SIDED|95.0|-31.47|-9.72||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-9.72|-31.47|0.0002
73928838|NCT00773175|147387295|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||TWO_SIDED|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||-3.1|-77.3|
73928839|NCT00773175|147387297|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|0.3|5.5|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||5.5|0.3|
73862742|NCT00121641|147271393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73|STANDARD_ERROR_OF_MEAN|5.48||0.0074|TWO_SIDED|95.0|-25.5|-3.97||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-3.97|-25.50|0.0074
73928840|NCT00773175|147387297|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-0.2|4.7|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||4.7|-0.2|
73928841|NCT00773175|147387298|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.8|1.9|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||1.9|-2.8|
73928842|NCT00773175|147387298|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.4|0.8|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||0.8|-3.4|
73928843|NCT00773175|147387309|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|0.1|0.3|||||Treatment difference = SC minus IV|||0.3|0.1|
73928844|NCT00773175|147387310|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0658|TWO_SIDED|95.0|-0.9|0.0|||ANOVA|From Analysis of Variance (ANOVA) model with center and treatment as factors.|Treatment difference = SC minus IV.|||0.0|-0.9|0.0658
73928845|NCT00773175|147387311|SUPERIORITY||Mean Difference (Net)|-1.0||||0.6208|TWO_SIDED|95.0|-4.8|2.9|||ANOVA|From ANOVA model with center and treatment as factors|Treatment difference = SC minus IV|||2.9|-4.8|0.6208
73928846|NCT00773175|147387313|SUPERIORITY|||||||0.0685||||||Cochran-Mantel-Haenszel (CMH) test controlling for center|Cochran-Mantel-Haenszel|Question 1||||||0.0685
73928847|NCT00773175|147387313|SUPERIORITY|||||||0.0004||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2||||||0.0004
73928848|NCT00773175|147387313|SUPERIORITY|||||||0.6861||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 3||||||0.6861
73928849|NCT00773175|147387313|SUPERIORITY|||||||0.2323||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4||||||0.2323
73928850|NCT00773175|147387314|SUPERIORITY|||||||0.0033||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Effectiveness||||||0.0033
73928851|NCT00773175|147387314|SUPERIORITY||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Degree of difficulty||||||< 0.0001
73970270|NCT04898673|147481028|SUPERIORITY||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-6.08|-4.37|||ANOVA|||||-4.37|-6.08|<0.001
73970271|NCT04898673|147481029|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.39||0.67|TWO_SIDED|95.0|-2.31|3.51|||ANOVA|||||3.51|-2.31|0.670
73970272|NCT04898673|147481030|NON_INFERIORITY|Non-inferiority margin=-10% words correct; CP1110 non-inferior to CP1000 if the lower limit of the confidence interval for the difference \> -10% words correct.|Mean Difference (Final Values)|-3.75|STANDARD_ERROR_OF_MEAN|1.55||0.026|TWO_SIDED|95.0|-7.0|-0.5|||ANOVA|||||-0.50|-7.00|0.026
73970273|NCT04898673|147481031|NON_INFERIORITY|Non-inferiority margin=-10% words correct; CP1110 non-inferior to CP1000 if the lower limit of the confidence interval for the difference \> -10% words correct.|Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.37||0.411|TWO_SIDED|95.0|-4.02|1.72|||ANOVA|||||1.72|-4.02|0.411
73970274|NCT01152450|147481043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.102|0.196|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.196|0.102|<0.0001
73970275|NCT01152450|147481043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.111|0.205|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.205|0.111|<0.0001
73970276|NCT01152450|147481043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.024||||95.0|-0.038|0.056|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.056|-0.038|
73928852|NCT00773175|147387315|SUPERIORITY|||||||0.2012||||||CMH test controlling for Center|Cochran-Mantel-Haenszel|Question 1||||||0.2012
73928853|NCT00773175|147387315|SUPERIORITY||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2||||||< 0.0001
73928854|NCT00773175|147387315|SUPERIORITY|||||||0.1302||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4||||||0.1302
73928855|NCT00773175|147387315|SUPERIORITY|||||||0.0852||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 5||||||0.0852
73928856|NCT00773175|147387315|SUPERIORITY|||||||0.0275||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 6||||||0.0275
74088050|NCT02709486|147729970|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0004|TWO_SIDED|95.0|-0.93|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.93|0.0004
74088051|NCT02709486|147729972|SUPERIORITY||Least Square Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.95|-0.42|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-0.95|<.0001
73928857|NCT00773175|147387321|SUPERIORITY|||||||0.0247|||||||Wilcoxon (Mann-Whitney)|||||||0.0247
73928858|NCT00773175|147387322|SUPERIORITY|||||||0.0007||||||CMH test controlling for center|Cochran-Mantel-Haenszel|||||||0.0007
73928859|NCT01904604|147387382|SUPERIORITY_OR_OTHER||Risk Difference (RD)|33.8||||0.005|TWO_SIDED|33.8|10.2|57.5||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.||57.5|10.2|0.005
73928860|NCT01904604|147387382|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.0||||0.003|TWO_SIDED|36.0|12.6|59.4||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.||59.4|12.6|0.003
73928861|NCT01904604|147387382|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.2||||0.48|TWO_SIDED|2.2|-25.8|30.1||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||||30.1|-25.8|0.48
73928862|NCT01904604|147387386|SUPERIORITY_OR_OTHER|||||||0.8||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.80
73928863|NCT01904604|147387386|SUPERIORITY_OR_OTHER|||||||0.008||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.008
73928864|NCT01904604|147387386|SUPERIORITY_OR_OTHER|||||||0.01||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.01
73928865|NCT05124665|147387390|EQUIVALENCE|Hypothesis is that proportion of contacts accepting HIV testing between two study arms is equivalent.|Odds Ratio (OR)|4.6||||0.004|TWO_SIDED|95.0|1.6|12.9|||Mixed Models Analysis|Cluster adjusted for household.||||12.9|1.6|0.004
73928866|NCT05124665|147387390|EQUIVALENCE|Hypothesis is proportion of contacts accepting HIV testing is equivalent between the two study arms|Mean Difference (Net)|6.0||||0.006|TWO_SIDED|95.0|2.0|10.0|||t-test, 2 sided||Estimated value and confidence interval reflects the values multiplied by 100 (converting decimal to percentage).|||10|2|0.006
73928867|NCT05124665|147387391|EQUIVALENCE|Hypothesis is that the change in stigma score is equivalent between the two study arms.|Slope|2.2||||0.358|TWO_SIDED|95.0|-2.5|6.9|||Mixed Models Analysis|||Van Rie Perceived TB and HIV Stigma scales adapted and validated in the Ugandan context are used. Scores range from 0 to 100 (standardized scale)||6.9|-2.5|0.358
73928868|NCT05124665|147387392|EQUIVALENCE|Hypothesis is that the difference in stigma score is equivalent between the two study arms|Slope|2.61||||0.199|TWO_SIDED|95.0|-1.38|6.59|||Mixed Models Analysis|||||6.59|-1.38|0.199
73928869|NCT05124665|147387393|EQUIVALENCE|Hypothesis is no effect from perceived HIV Stigma on HIV Test Uptake|Coefficient from Structural Equation|0.00087||||0.03|TWO_SIDED|95.0|0.00007|0.00167|||Structural Equation Modeling|||||0.00167|0.00007|0.03
73928870|NCT05124665|147387394|EQUIVALENCE|Hypothesis is that TB stigma has no effect of HIV test uptake|Coefficient Structural Equation Model|0.0002||||0.64|TWO_SIDED|95.0|-0.0007|0.0011|||Structural Equation Modeling|||||0.0011|-0.0007|0.64
73928871|NCT05124665|147387395|EQUIVALENCE|Hypothesis is that proportion of index patient nominated household contacts accepting HIV testing is equivalent between two study arms||||||0.452|||||||Chi-squared|||||||0.452
73928872|NCT05124665|147387396|NON_INFERIORITY|Hypothesis is that the first tester's decision to test does not impact subsequent household contacts decision to test for HIV.|Risk Ratio (RR)|1.23||||0.264|TWO_SIDED|95.0|0.86|1.76|||Regression, Logistic|||||1.76|0.86|0.264
73928873|NCT05124665|147387397|EQUIVALENCE|Hypothesis is that the index patient and contact nominations will match equally regardless of study arm.|||||<|0.001|||||||Chi-squared|||||||<0.001
73928874|NCT01481116|147387409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
73970277|NCT01152450|147481044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.328|STANDARD_ERROR_OF_MEAN|5.19|<|0.0001||95.0|11.084|31.573|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||31.573|11.084|<0.0001
73928875|NCT01481116|147387409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
73928876|NCT01481116|147387409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
73928877|NCT01481116|147387409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
73928878|NCT01481116|147387410|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.707||0.065|TWO_SIDED|95.0|-2.7|0.08||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78||0.08|-2.70|0.065
73928879|NCT01481116|147387410|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.678||0.034|TWO_SIDED|95.0|-2.78|-0.11||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78||-0.11|-2.78|0.034
73928880|NCT02633956|147387427|OTHER|Estimation|Least Square Mean Difference|13.79|STANDARD_ERROR_OF_MEAN|5.75|||TWO_SIDED|95.0|2.28|25.3||||||||25.30|2.28|
73928881|NCT02633956|147387427|OTHER|Estimation|Least Square Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|5.61|||TWO_SIDED|95.0|-2.18|20.3||||||||20.30|-2.18|
73928882|NCT02633956|147387427|OTHER|Estimation|Least Square Mean Difference|20.13|STANDARD_ERROR_OF_MEAN|6.39|||TWO_SIDED|95.0|7.33|32.92||||||||32.92|7.33|
73928883|NCT02633956|147387428|OTHER|Estimation|Least Square Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.07|0.75||||||||0.75|0.07|
73928884|NCT02633956|147387428|OTHER|Estimation|Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.25|0.42||||||||0.42|-0.25|
73928885|NCT02633956|147387428|OTHER|Estimation|Least Square Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.14|0.89||||||||0.89|0.14|
73928886|NCT02633956|147387429|OTHER|Estimation|Least Square Mean Difference|103.61|STANDARD_ERROR_OF_MEAN|69.51|||TWO_SIDED|95.0|-35.58|242.81||||||||242.81|-35.58|
73928887|NCT02633956|147387429|OTHER|Estimation|Least Square Mean Difference|114.8|STANDARD_ERROR_OF_MEAN|68.08|||TWO_SIDED|95.0|-21.53|251.13||||||||251.13|-21.53|
73928888|NCT02633956|147387429|OTHER|Estimation|Least Square Mean Difference|215.05|STANDARD_ERROR_OF_MEAN|79.51|||TWO_SIDED|95.0|55.84|374.26||||||||374.26|55.84|
73928889|NCT02704364|147387484|SUPERIORITY||Hodges-Lehmann estimate|-14.0|STANDARD_ERROR_OF_MEAN|21.4||0.434|TWO_SIDED|95.0|-68.0|28.0|||Wilcoxon (Mann-Whitney)|||||28.0|-68.0|0.434
73928890|NCT02704364|147387484|SUPERIORITY||Hodges-Lehmann estimate|13.0|STANDARD_ERROR_OF_MEAN|25.0||0.646|TWO_SIDED|95.0|-41.0|71.0|||Wilcoxon (Mann-Whitney)|||||71.0|-41.0|0.646
73928891|NCT02975934|147387502|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.36|0.69|||Log Rank|||||0.69|0.36|<0.001
73928892|NCT02975934|147387503|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||||0.80|0.47|<0.001
73928893|NCT02975934|147387504|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.5044|TWO_SIDED|95.0|0.68|1.2|||Log Rank|||||1.20|0.68|0.5044
73928894|NCT02975934|147387505|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9368|TWO_SIDED|95.0|0.78|1.26|||Log Rank|||||1.26|0.78|0.9368
73928895|NCT02075840|147387533|SUPERIORITY||Hazard Ratio, stratified|0.47|||<|0.0001|TWO_SIDED|95.0|0.34|0.65|||Log Rank|||Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.||0.65|0.34|<0.0001
73928896|NCT02075840|147387535|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.7|||Log Rank|Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.||||0.70|0.36|<0.0001
73928897|NCT02075840|147387537|SUPERIORITY|IRC, RECIST v1.1 Stratified Analysis (by race (Asian vs non-Asian) and CNS metastases at baseline by IRC)|Cause-Specific Hazard Ratio|0.16|||<|0.0001|TWO_SIDED|95.0|0.1|0.28|||Log Rank|||||0.28|0.10|<0.0001
73928898|NCT02075840|147387539|SUPERIORITY||Difference in Overall Response Rates|7.4||||0.0936|TWO_SIDED|95.0|-1.71|16.5||Stratified analysis|Mantel Haenszel|||||16.50|-1.71|0.0936
73928899|NCT02075840|147387541|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2405|TWO_SIDED|95.0|0.48|1.2||Stratified analysis|Log Rank|||||1.20|0.48|0.2405
73928900|NCT02075840|147387552|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2079|TWO_SIDED|95.0|0.46|1.19|||Log Rank|Stratified analysis||Fatigue||1.19|0.46|0.2079
73928901|NCT02075840|147387552|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.1137|TWO_SIDED|95.0|0.88|3.15||Stratified analysis|Log Rank|||Dyspnea||3.15|0.88|0.1137
73928902|NCT02075840|147387554|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.7042|TWO_SIDED|95.0|0.44|1.74||Stratified analysis|Log Rank|||Coughing||1.74|0.44|0.7042
73928903|NCT02075840|147387554|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.0285|TWO_SIDED|95.0|1.05|2.92||Stratified analysis|Log Rank|||Dyspnea||2.92|1.05|0.0285
73928904|NCT02075840|147387554|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.2377|TWO_SIDED|95.0|0.79|2.61||Stratified analysis|Log Rank|||Pain in arm and shoulder||2.61|0.79|0.2377
73928905|NCT02075840|147387554|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0796|TWO_SIDED|95.0|0.24|1.1||Stratified analysis|Log Rank|||Pain in chest||1.10|0.24|0.0796
73928906|NCT02075840|147387554|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.6435|TWO_SIDED|95.0|0.72|1.68||Stratified analysis|Log Rank|||Composite score||1.68|0.72|0.6435
73928907|NCT01103934|147387578|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.09
73928908|NCT01103934|147387579|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
73928909|NCT00792610|147387582|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|STANDARD_DEVIATION|0.05|<|0.05||95.0|0.05|0.15|||t-test, 2 sided|||Chi-square analysis and Fischer's exact test were used for comparing group proportions between seropositive and seronegative participants. GMT and their 95% confidence intervals were also calculated using the software developed by Kirkman, T.W. (18) An ANOVA test was performed to compare the difference of the three groups at one, six and seven months categorized by the anti-HBs titers at 7-10 days after the booster.||.15|.05|<0.05
73928910|NCT04889625|147387583|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.0085|||TWO_SIDED|95.0|-0.017|0.017|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Distance (4m)||0.017|-0.017|
73928911|NCT04889625|147387583|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.0108|||TWO_SIDED|95.0|-0.051|-0.008|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Intermediate (64cm)||-0.008|-0.051|
73928912|NCT04889625|147387583|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|-0.036|STANDARD_ERROR_OF_MEAN|0.0129|||TWO_SIDED|95.0|-0.062|-0.011|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Near (40cm)||-0.011|-0.062|
73970278|NCT01152450|147481044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.357|STANDARD_ERROR_OF_MEAN|5.225|<|0.0001||95.0|12.044|32.67|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||32.670|12.044|<0.0001
73928913|NCT04889625|147387584|NON_INFERIORITY|This study was powered to demonstrate the primary hypotheses. However, the final sample size calculation was deemed large enough to test for Non-inferiority of the Test relative to the Control. A non-inferiority margin of -5 points was used.|least-square mean difference|6.3|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|2.0|10.5|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A (C3)- delefilcon A|||10.5|2.0|
73928914|NCT02659020|147387613|SUPERIORITY||Hazard Ratio (HR)|0.945||||0.775|TWO_SIDED|95.0|0.639|1.397||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.397|0.639|0.775
73928915|NCT02659020|147387623|SUPERIORITY||Hazard Ratio (HR)|0.667||||0.148|TWO_SIDED|95.0|0.385|1.158||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.158|0.385|0.148
73928916|NCT02659020|147387624|SUPERIORITY||Hazard Ratio (HR)|0.692||||0.055|TWO_SIDED|95.0|0.476|1.007||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.007|0.476|0.055
73928917|NCT02659020|147387624|SUPERIORITY||Hazard Ratio (HR)|0.828||||0.482|TWO_SIDED|95.0|0.49|1.398||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank|||||1.398|0.490|0.482
73928918|NCT02659020|147387625|SUPERIORITY||Odds Ratio (OR)|1.589||||0.1891|TWO_SIDED|95.0|0.794|3.179||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||3.179|0.794|0.1891
73970279|NCT01152450|147481044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.029|STANDARD_ERROR_OF_MEAN|5.242||||95.0|-9.318|11.376|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||11.376|-9.318|
73970280|NCT01152450|147481045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.92|STANDARD_ERROR_OF_MEAN|5.026|<|0.0001||95.0|20.001|39.839|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||39.839|20.001|<0.0001
73970281|NCT01152450|147481045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.657|STANDARD_ERROR_OF_MEAN|5.042|<|0.0001||95.0|18.707|38.606|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||38.606|18.707|<0.0001
73928919|NCT02659020|147387625|SUPERIORITY||Odds Ratio (OR)|2.668||||0.0642|TWO_SIDED|95.0|0.923|7.71||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||7.710|0.923|0.0642
73928920|NCT02659020|147387626|SUPERIORITY||Odds Ratio (OR)|1.106||||0.7724|TWO_SIDED|95.0|0.558|2.194||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||2.194|0.558|0.7724
73928921|NCT02659020|147387626|SUPERIORITY||Odds Ratio (OR)|1.222||||0.6508|TWO_SIDED|95.0|0.513|2.911||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||2.911|0.513|0.6508
73928922|NCT02659020|147387627|SUPERIORITY||Hazard Ratio (HR)|0.661||||0.073|TWO_SIDED|95.0|0.419|1.041||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.041|0.419|0.073
73928923|NCT02659020|147387627|SUPERIORITY||Hazard Ratio (HR)|0.703||||0.225|TWO_SIDED|95.0|0.395|1.253||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.253|0.395|0.225
73928924|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|1.213||||0.332|TWO_SIDED|95.0|0.834|1.764||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Fatigue||1.764|0.834|0.332
73928925|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.389|TWO_SIDED|95.0|0.514|1.287||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Nausea and vomiting||1.287|0.514|0.389
73928926|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|0.598||||0.02|TWO_SIDED|95.0|0.386|0.926||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Pain||0.926|0.386|0.020
73928927|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.821|TWO_SIDED|95.0|0.622|1.442||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Dyspnoea||1.442|0.622|0.821
73928928|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|0.931||||0.812|TWO_SIDED|95.0|0.574|1.509||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Insomnia||1.509|0.574|0.812
73928929|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.162|TWO_SIDED|95.0|0.893|2.055||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Appetite loss||2.055|0.893|0.162
73928930|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|0.881||||0.619|TWO_SIDED|95.0|0.55|1.413||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Constipation||1.413|0.550|0.619
73928931|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|1.134||||0.597|TWO_SIDED|95.0|0.746|1.724||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Diarrhoea||1.724|0.746|0.597
73970282|NCT01152450|147481045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.264|STANDARD_ERROR_OF_MEAN|5.056||||95.0|-11.243|8.716|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||8.716|-11.243|
73928932|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|0.766||||0.38|TWO_SIDED|95.0|0.425|1.381||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Financial difficulties||1.381|0.425|0.380
73928933|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|1.046||||0.877|TWO_SIDED|95.0|0.635|1.723||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Fatigue||1.723|0.635|0.877
74088052|NCT02709486|147729972|SUPERIORITY||Least Square Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.14||0.0014|TWO_SIDED|95.0|-0.7|-0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.70|0.0014
73928934|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|1.102||||0.791|TWO_SIDED|95.0|0.568|2.139||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Nausea and vomiting||2.139|0.568|0.791
73928935|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.487|TWO_SIDED|95.0|0.454|1.443||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Pain||1.443|0.454|0.487
73928936|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|1.014||||0.976|TWO_SIDED|95.0|0.556|1.85||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Dyspnoea||1.850|0.556|0.976
73928937|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|1.694||||0.111|TWO_SIDED|95.0|0.882|3.25||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Insomnia||3.250|0.882|0.111
73928938|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|1.108||||0.76|TWO_SIDED|95.0|0.62|1.979||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Appetite loss||1.979|0.620|0.760
73928939|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|1.119||||0.747|TWO_SIDED|95.0|0.586|2.135||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Constipation||2.135|0.586|0.747
73928940|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|1.367||||0.33|TWO_SIDED|95.0|0.726|2.576||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Diarrhoea||2.576|0.726|0.330
73928941|NCT02659020|147387628|SUPERIORITY||Hazard Ratio (HR)|1.373||||0.411|TWO_SIDED|95.0|0.636|2.965||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Financial difficulties||2.965|0.636|0.411
73928942|NCT04382911|147387631|EQUIVALENCE|A 2x2 table was constructed among all patients with histopathologically identified endometriosis (true positive) to compare sensitivity for FES PET/MRI versus sensitivity of conventional MRI.||||||0.317|||||||McNemar|||||||0.317
73928943|NCT04382911|147387634|OTHER|A random effects linear regression model, modeling SUV-max as a function of the pain rating, while controlling for patient-level covariates (BMI, race, age) was performed. The investigators included physician as a random effect to account for physician-level correlation.|Slope|0.748||||0.24|TWO_SIDED||||||Pearson's Correlation Coefficient|||||||0.24
73928944|NCT04382911|147387634|OTHER|The investigators will implement a random effects linear regression model, modeling SUV-max as a function of EHP-30, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation.|Slope|0.406||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
73970283|NCT01152450|147481046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.12|0.218|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.218|0.120|<0.0001
73928945|NCT04521166|147387635|OTHER|A linear mixed model was used to assess whether there was a difference between Settings 1 and 2.|Slope|-0.0099|STANDARD_ERROR_OF_MEAN|0.01572||0.5291|TWO_SIDED|95.0|-0.04075|0.02095||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 1 is significantly different from the slope for Setting 2|||0.02095|-0.04075|0.5291
73928946|NCT04521166|147387635|OTHER|A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 3.|Slope|0.1329|STANDARD_ERROR_OF_MEAN|0.0174|<|0.001|TWO_SIDED|95.0|0.0988|0.1671||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 3 is significantly different from the slope for Setting 2|||0.1671|0.09880|<0.001
73928947|NCT04521166|147387635|OTHER|A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 4.|Slope|0.2016|STANDARD_ERROR_OF_MEAN|0.01812|<|0.0001|TWO_SIDED|95.0|0.166|0.2371||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 4 is significantly different from the slope for Setting|||0.2371|0.1660|<.0001
73928948|NCT04521166|147387635|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)||||0.242
73970284|NCT01152450|147481046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.136|0.234|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.234|0.136|<0.0001
73970285|NCT01152450|147481046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.025||||95.0|-0.033|0.065|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.065|-0.033|
74029474|NCT00719576|147613473|SUPERIORITY||||||<|0.001||||||KOOS other symptoms p-value \<0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||<0.001
73928949|NCT04521166|147387635|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)||||0.242
73928950|NCT04521166|147387635|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).||||0.242
74029475|NCT00631488|147613478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.9||||0.002|TWO_SIDED|95.0|5.2|22.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval (CI) for the between group difference.||22.7|5.2|0.002
74029476|NCT00631488|147613478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||<|0.001|TWO_SIDED|95.0|-26.5|-9.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-9.2|-26.5|<0.001
73928951|NCT04521166|147387635|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).||||0.242
73970286|NCT01152450|147481047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.077|0.181|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.181|0.077|<0.0001
73970287|NCT01152450|147481047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.079|0.183|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.183|0.079|<0.0001
73970288|NCT01152450|147481047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.05|0.054|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.054|-0.050|
74029477|NCT00631488|147613479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1||||0.05|TWO_SIDED|95.0|0.0|18.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||18.2|0.0|0.050
74029478|NCT00631488|147613479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.001|TWO_SIDED|95.0|-28.0|-10.1|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-10.1|-28.0|<0.001
73928952|NCT02614547|147387637|SUPERIORITY||Least Squares Mean Difference|-12.22|STANDARD_ERROR_OF_MEAN|4.081||0.008|TWO_SIDED|95.0|-20.77|-3.67|||MMRM|||Mixed Effects Model for Repeated Measure (MMRM) used an unstructured covariance model time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-3.67|-20.77|0.008
73928953|NCT02614547|147387638|SUPERIORITY||Odds Ratio (OR)|4.08||||0.198|TWO_SIDED|95.0|0.49|37.67|||Fisher Exact|||60 Hours||37.67|0.49|0.198
73928954|NCT02614547|147387638|SUPERIORITY||Odds Ratio (OR)|16.0||||0.023|TWO_SIDED|95.0|1.31|239.57|||Fisher Exact|||Day 7||239.57|1.31|0.023
73928955|NCT02614547|147387638|SUPERIORITY||Odds Ratio (OR)|6.22||||0.086|TWO_SIDED|95.0|0.7|62.08|||Fisher Exact|||Day 30||62.08|0.70|0.086
73928956|NCT02614547|147387639|SUPERIORITY||Odds Ratio (OR)|23.33||||0.008|TWO_SIDED|95.0|1.56|1152.71|||Fisher Exact|||60 Hours||1152.71|1.56|0.008
73928957|NCT02614547|147387639|SUPERIORITY|||||||0.003|||||||Fisher Exact|||Day 7||||0.003
73928958|NCT02614547|147387639|SUPERIORITY||Odds Ratio (OR)|10.5||||0.03|TWO_SIDED|95.0|1.01|140.57|||Fisher Exact|||Day 30||140.57|1.01|0.030
74029479|NCT00631488|147613480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.6||||0.056|TWO_SIDED|95.0|-0.6|45.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||45.8|-0.6|0.056
74029480|NCT00631488|147613480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.6|||<|0.001|TWO_SIDED|95.0|-67.3|-21.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-21.8|-67.3|<0.001
73928959|NCT02614547|147387640|SUPERIORITY||Least Squares Mean Difference|-15.86|STANDARD_ERROR_OF_MEAN|5.536||0.01|TWO_SIDED|95.0|-27.5|-4.22|||MMRM|||60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.22|-27.50|0.010
73928960|NCT02614547|147387640|SUPERIORITY||Least Square Mean Difference|-15.96|STANDARD_ERROR_OF_MEAN|5.448||0.009|TWO_SIDED|95.0|-27.43|-4.5|||MMRM|||Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.50|-27.43|0.009
73928961|NCT02614547|147387640|SUPERIORITY||Least Square Mean Difference|-15.07|STANDARD_ERROR_OF_MEAN|5.213||0.01|TWO_SIDED|95.0|-26.05|-4.09|||MMRM|||Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.09|-26.05|0.010
73928962|NCT02614547|147387641|SUPERIORITY||Odds Ratio (OR)|7.0||||0.08|TWO_SIDED|95.0|0.73|90.81|||Fisher Exact|||60 Hours||90.81|0.73|0.080
73928963|NCT02614547|147387641|SUPERIORITY||Odds Ratio (OR)|16.0||||0.023|TWO_SIDED|95.0|1.31|239.57|||Fisher Exact|||Day 7||239.57|1.31|0.023
73928964|NCT02614547|147387641|SUPERIORITY||Odds Ratio (OR)|10.67||||0.03|TWO_SIDED|95.0|1.04|142.2|||Fisher Exact|||Day 30||142.20|1.04|0.030
73928965|NCT02614547|147387642|SUPERIORITY||Least Squares Mean Difference|-6.05|STANDARD_ERROR_OF_MEAN|2.466||0.025|TWO_SIDED|95.0|-11.24|-0.86|||MMRM|||60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-0.86|-11.24|0.025
73928966|NCT02614547|147387642|SUPERIORITY||Least Squares Mean Difference|-6.46|STANDARD_ERROR_OF_MEAN|2.427||0.016|TWO_SIDED|95.0|-11.57|-1.34|||MMRM|||Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-1.34|-11.57|0.016
73928967|NCT02614547|147387642|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|2.568||0.018|TWO_SIDED|95.0|-12.25|-1.35|||MMRM|||Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-1.35|-12.25|0.018
73928968|NCT02614547|147387644|SUPERIORITY||Least Squares Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|2.461||0.457|TWO_SIDED|95.0|-3.3|7.04|||ANCOVA|||60 Hours||7.04|-3.30|0.457
73928969|NCT02614547|147387644|SUPERIORITY||Least Square Mean|-1.47|STANDARD_ERROR_OF_MEAN|-1.47||0.613|TWO_SIDED|95.0|-7.5|4.55|||ANCOVA|||Day 7||4.55|-7.50|0.613
73928970|NCT02614547|147387644|SUPERIORITY||Least Square Mean|-2.1|STANDARD_ERROR_OF_MEAN|2.871||0.474|TWO_SIDED|95.0|-8.13|3.93|||ANCOVA|||Day 30||3.93|-8.13|0.474
73928971|NCT01120210|147387663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.0595|TWO_SIDED|90.0|-0.016|0.564|||ANCOVA|one-sided p-value and one-sided alpha=0.05||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 5 ng/kg/min dose.||0.564|-0.016|0.0595
73928972|NCT01120210|147387663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.0215|TWO_SIDED|90.0|0.064|0.595||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 15 ng/kg/min dose.||0.595|0.064|0.0215
73928973|NCT01120210|147387663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.0049|TWO_SIDED|90.0|0.214|0.921||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 30 ng/kg/min dose.||0.921|0.214|0.0049
74088053|NCT02709486|147729972|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.09|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.09|<.0001
73928974|NCT01120210|147387664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.4729|TWO_SIDED|90.0|-2.312|2.131||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 5 ng/kg/min dose.||2.131|-2.312|0.4729
73928975|NCT01120210|147387664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.2123|TWO_SIDED|90.0|-4.164|1.464||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 15 ng/kg/min dose.||1.464|-4.164|0.2123
73928976|NCT01120210|147387664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.58||||0.0821|TWO_SIDED|90.0|-5.639|0.483||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 30 ng/kg/min dose.||0.483|-5.639|0.0821
74088054|NCT02709486|147729972|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.08|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.08|<.0001
74088055|NCT02709486|147729972|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.93|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-0.93|<.0001
73862743|NCT00121641|147271393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.81|STANDARD_ERROR_OF_MEAN|5.58|<|0.0001|TWO_SIDED|95.0|-33.79|-11.84||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-11.84|-33.79|<.0001
73928977|NCT01120210|147387665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.7682|TWO_SIDED|95.0|-2.527|1.879||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 5 ng/kg/min dose.||1.879|-2.527|0.7682
73928978|NCT01120210|147387665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.4107|TWO_SIDED|95.0|-1.764|4.235||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 15 ng/kg/min dose.||4.235|-1.764|0.4107
73928979|NCT01120210|147387665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16||||0.1811|TWO_SIDED|95.0|-1.046|5.372||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 30 ng/kg/min dose.||5.372|-1.046|0.1811
73928980|NCT01120210|147387666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.803|TWO_SIDED|95.0|-6.06|4.718||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 5 ng/kg/min dose.||4.718|-6.060|0.8030
73928981|NCT01120210|147387666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.4923|TWO_SIDED|95.0|-7.781|3.801||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 15 ng/kg/min dose.||3.801|-7.781|0.4923
73928982|NCT01120210|147387666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77||||0.3152|TWO_SIDED|95.0|-11.251|3.708||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 30 ng/kg/min dose.||3.708|-11.251|0.3152
73970289|NCT01152450|147481048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.179|0.084|<0.0001
73970290|NCT01152450|147481048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.179|0.084|<0.0001
73970291|NCT01152450|147481048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.024||||95.0|-0.048|0.047|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.047|-0.048|
74029481|NCT00631488|147613481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.001|TWO_SIDED|95.0|1.7|6.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||6.7|1.7|0.001
73928983|NCT01120210|147387667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36||||0.1561||95.0|-8.047|1.331||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 5 ng/kg/min dose.||1.331|-8.047|0.1561
74029482|NCT00631488|147613481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|||<|0.001|TWO_SIDED|95.0|10.7|15.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||15.7|10.7|<0.001
74029483|NCT00631488|147613482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.001|TWO_SIDED|95.0|-9.5|-3.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference||-3.8|-9.5|<0.001
74029484|NCT00631488|147613482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.001|TWO_SIDED|95.0|-14.1|-8.5|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||-8.5|-14.1|<0.001
73928984|NCT01120210|147387667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55||||0.0282|TWO_SIDED|95.0|-10.482|-0.622||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 15 ng/kg/min dose.||-0.622|-10.482|0.0282
74088056|NCT02709486|147729972|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.06|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.06|<.0001
73862744|NCT00121641|147271394|SUPERIORITY_OR_OTHER||Difference in Proportions|11.1||||0.1141|TWO_SIDED|95.0|-3.1|24.9||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||24.9|-3.1|0.1141
73928985|NCT01120210|147387667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.08||||0.0043|TWO_SIDED|95.0|-11.818|-2.332||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 30 ng/kg/min dose.||-2.332|-11.818|0.0043
73928986|NCT01120210|147387668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.9769|TWO_SIDED|95.0|-16.347|16.823||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in left ventricular end systolic volume (LVESV) at the end of the 30 ng/kg/min dose.||16.823|-16.347|0.9769
74029485|NCT00103194|147613492|SUPERIORITY_OR_OTHER||PSA response rate|0.0|||||TWO_SIDED|90.0|0.0|8.2||||||||8.2|0|
74029486|NCT00103194|147613493|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Mixed Models Analysis|The analysis is testing the null hypothesis that there is no difference between the pre-treatment and post-treatment PSA slopes.||||||0.006
74029487|NCT03864237|147613513|SUPERIORITY||beta coefficient for condition|0.53|STANDARD_ERROR_OF_MEAN|0.93||0.568|TWO_SIDED|95.0|-1.31|2.37|||Regression, Linear|Regression controls for baseline value of outcome and sex to determine pre-post change in the outcome as a function of condition.||||2.37|-1.31|0.568
73928987|NCT01120210|147387669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.98||||0.8297|TWO_SIDED|95.0|-16.592|20.551||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEDV at the end of the 30 ng/kg/min dose.||20.551|-16.592|0.8297
73928988|NCT01120210|147387670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.865|TWO_SIDED|95.0|-3.352|3.968||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEF at the end of the 30 ng/kg/min dose.||3.968|-3.352|0.8650
73862745|NCT00121641|147271394|SUPERIORITY_OR_OTHER||Difference in Proportions|14.0||||0.0443|TWO_SIDED|95.0|-0.1|27.6||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||27.6|-0.1|0.0443
73928989|NCT01120210|147387671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95||||0.3748|TWO_SIDED|95.0|-1.204|3.102||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in FS at the end of the 30 ng/kg/min dose.||3.102|-1.204|0.3748
73928990|NCT01120210|147387672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.08||||0.2123|TWO_SIDED|95.0|-4.198|18.359||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 5 ng/kg/min dose.||18.359|-4.198|0.2123
73928991|NCT01120210|147387672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.78||||0.1083|TWO_SIDED|95.0|-2.016|19.575||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.||19.575|-2.016|0.1083
73928992|NCT01120210|147387672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.16||||0.018|TWO_SIDED|95.0|2.557|25.771||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 30 ng/kg/min dose.||25.771|2.557|0.0180
73928993|NCT01120210|147387673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.4841|TWO_SIDED|95.0|-5.308|2.554||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 5 ng/kg/min dose.||2.554|-5.308|0.4841
73928994|NCT01120210|147387673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.6665|TWO_SIDED|95.0|-5.567|3.594||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.||3.594|-5.567|0.6665
73928995|NCT01120210|147387673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.6904|TWO_SIDED|95.0|-4.107|6.148||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 30 ng/kg/min dose.||6.148|-4.107|0.6904
73928996|NCT01120210|147387674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.6304|TWO_SIDED|95.0|-2.197|3.588||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 5 ng/kg/min dose.||3.588|-2.197|0.6304
73928997|NCT01120210|147387674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.842|TWO_SIDED|95.0|-3.851|3.153||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 15 ng/kg/min dose.||3.153|-3.851|0.8420
73928998|NCT01120210|147387674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.6658|TWO_SIDED|95.0|-4.138|2.669||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 30 ng/kg/min dose.||2.669|-4.138|0.6658
73928999|NCT01120210|147387675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-264.36||||0.051|TWO_SIDED|95.0|-529.875|1.147||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 5 ng/kg/min dose.||1.147|-529.875|0.0510
73929000|NCT01120210|147387675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-383.32||||0.0006|TWO_SIDED|95.0|-592.781|-173.867||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 15 ng/kg/min dose.||-173.867|-592.781|0.0006
73929001|NCT01120210|147387675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-527.77||||0.0001|TWO_SIDED|95.0|-764.07|-291.478||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 30 ng/kg/min dose.||-291.478|-764.070|0.0001
73929002|NCT05320029|147387741|NON_INFERIORITY|If the two-side 95%CI limit of the difference between the two groups is greater than the non-inferiority margin of -10%, the non-inferiority hypothesis of this study is valid|Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.0458|0.0458|||Newcombe-Wilson|||||0.0458|-0.0458|<0.05
73929003|NCT01494610|147387850|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.508|||||TWO_SIDED|90.0|1.366|1.665|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.665|1.366|
73929004|NCT01494610|147387850|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.598|||||TWO_SIDED|90.0|1.369|1.864|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.864|1.369|
73929005|NCT01494610|147387850|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.421|||||TWO_SIDED|90.0|1.274|1.584|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.584|1.274|
73929006|NCT01494610|147387851|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.928|||||TWO_SIDED|90.0|0.886|0.971|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||0.971|0.886|
74029488|NCT03864237|147613514|SUPERIORITY||beta coefficient for condition|1.22|STANDARD_ERROR_OF_MEAN|0.69||0.077|TWO_SIDED|95.0|-0.13|2.59|||Regression, Linear|||||2.59|-0.13|0.077
74029489|NCT03864237|147613515|SUPERIORITY||beta coefficient for condition|-1.21|STANDARD_ERROR_OF_MEAN|1.17||0.3|TWO_SIDED|95.0|-3.52|1.11|||Regression, Linear|||||1.11|-3.52|0.30
74029490|NCT03864237|147613516|SUPERIORITY||beta coefficient for condition|0.84|STANDARD_ERROR_OF_MEAN|1.09||0.44|TWO_SIDED|95.0|-1.31|3.0|||Regression, Linear|||||3.0|-1.31|0.44
74029491|NCT03864237|147613517|SUPERIORITY||Beta coefficient for condition|-0.25|STANDARD_ERROR_OF_MEAN|1.29||0.845|TWO_SIDED|95.0|-2.81|2.3|||Regression, Linear|||||2.30|-2.81|0.845
74029492|NCT03864237|147613518|SUPERIORITY||Beta coefficient for condition|0.3|STANDARD_ERROR_OF_MEAN|1.01||0.77|TWO_SIDED|95.0|-1.72|2.31|||Regression, Linear|||||2.31|-1.72|0.77
74029493|NCT03864237|147613519|SUPERIORITY||Beta coefficient for condition|1.77|STANDARD_ERROR_OF_MEAN|1.4||0.21|TWO_SIDED|95.0|-1.0|4.54|||Regression, Linear|||||4.54|-1.0|0.21
74029494|NCT02546856|147613520|NON_INFERIORITY|For the hypothesis that the relative dose of BBs would reach 52% by the end of the study and using an equivalence margin of 7%, we would need 157 patients per group for an alpha level of significance of 0.05 and a statistical power of 80% (beta of 0.80).|Mean Difference (Final Values)|14.8|||<|0.001|TWO_SIDED|95.0|7.5|22.1|||t-test, 2 sided|||||22.1|7.5|<0.001
74029495|NCT02546856|147613521|EQUIVALENCE|equivalence margin of 5%|Difference in percentages|1.4||||0.52|TWO_SIDED|95.0|-3.33|6.32|||Chi-squared|||||6.32|-3.33|0.52
74029496|NCT02546856|147613522|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|2.1||||0.31|TWO_SIDED|95.0|-1.9|6.1|||Chi-squared|||||6.1|-1.9|0.31
74029497|NCT02546856|147613523|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|-0.63||||0.85|TWO_SIDED|95.0|-7.1|5.85|||Chi-squared|||||5.85|-7.1|0.85
74029498|NCT02546856|147613524|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|2.12||||0.44|TWO_SIDED|95.0|-3.3|7.54|||Chi-squared|||||7.54|-3.3|0.44
74029499|NCT02546856|147613526|NON_INFERIORITY|equivalence margin of 5%|Difference in percentages|0.7||||0.56|TWO_SIDED|95.0|-1.6|3.04|||Chi-squared|||||3.04|-1.6|0.56
74029500|NCT02546856|147613530|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|0.07||||0.96|TWO_SIDED|95.0|-2.69|2.83|||t-test, 2 sided|||||2.83|-2.69|0.96
74029501|NCT02546856|147613531|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|16.47||||0.97|TWO_SIDED|95.0|-781.0|748.0|||t-test, 2 sided|||||748|-781|0.97
74029502|NCT02546856|147613532|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|7.28||||0.44|TWO_SIDED|95.0|-11.27|25.83|||t-test, 2 sided|||||25.83|-11.27|0.44
74029503|NCT02546856|147613534|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|-0.91||||0.75|TWO_SIDED|95.0|-6.63|4.81|||t-test, 2 sided|||||4.81|-6.63|0.75
74029504|NCT02546856|147613535|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|0.04||||0.2|TWO_SIDED|95.0|-0.2|0.28|||t-test, 2 sided|||||0.28|-0.2|0.20
74029505|NCT02546856|147613536|EQUIVALENCE|equivalence margin of 5%|Difference in percentages|-5.5||||0.01|TWO_SIDED|95.0|-9.7|-1.4|||Chi-squared|||||-1.4|-9.7|0.01
74029506|NCT02546856|147613537|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|-0.68||||0.71|TWO_SIDED|95.0|-4.2|2.87|||Chi-squared|Equivalence margin of 7%||||2.87|-4.2|0.71
74029507|NCT02546856|147613538|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|16.5|||<|0.001|TWO_SIDED|95.0|8.7|24.3|||t-test, 2 sided|||||24.3|8.7|<0.001
74029508|NCT02546856|147613539|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|0.9||||0.93|TWO_SIDED|95.0|-15.1|17.1|||t-test, 2 sided|||||17.1|-15.1|0.93
74029509|NCT02546856|147613540|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|0.5||||0.86|TWO_SIDED|95.0|-7.1|8.2|||t-test, 2 sided|||||8.2|-7.1|0.86
74029510|NCT01097616|147613544|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.6|||<|1e-05|TWO_SIDED|95.0|12.0|27.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||27.1|12.0|<0.00001
74029511|NCT01097616|147613545|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.7|||<|1e-05|TWO_SIDED|95.0|11.9|27.6||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||27.6|11.9|<0.00001
74029512|NCT01097616|147613546|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-26.3|||<|1e-05|TWO_SIDED|95.0|-33.5|-19.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-19.2|-33.5|<0.00001
74088057|NCT02709486|147729972|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.11|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.11|<.0001
73929007|NCT01494610|147387851|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.892|||||TWO_SIDED|90.0|0.848|0.939|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||0.939|0.848|
73929008|NCT01494610|147387851|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.966|||||TWO_SIDED|90.0|0.889|1.049|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.049|0.889|
73929009|NCT00384813|147387928|SUPERIORITY_OR_OTHER||regression coefficient|0.33||||0.23||||||For both baseline to 4 month analyses (see above p value) and baseline to 10 month analyses, the variable of intervention group did not contribute significant additional variance.|Regression, Linear|||||||0.23
73929010|NCT00749931|147387992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74029513|NCT01097616|147613547|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-22.9|||<|1e-05|TWO_SIDED|95.0|-30.3|-15.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-15.4|-30.3|<0.00001
74088058|NCT02709486|147729972|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.15|<.0001
74088059|NCT02709486|147729972|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.0|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.34|-1.00|<.0001
73929011|NCT00749931|147387993|SUPERIORITY_OR_OTHER||Relative reduction|0.47||||0.002|||||||Fisher Exact|||||||0.002
73929012|NCT01153581|147387996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73929013|NCT01806896|147388013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.68||0.68|TWO_SIDED|90.0|-3.56|2.15||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effects and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Day 28)||2.15|-3.56|0.68
73929014|NCT01806896|147388015|SUPERIORITY_OR_OTHER||Least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.79|TWO_SIDED|90.0|-0.72|0.52||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew\>Neut Left VS)||0.52|-0.72|0.79
73929015|NCT01806896|147388015|SUPERIORITY_OR_OTHER||Least square mean|-0.15|STANDARD_ERROR_OF_MEAN|0.37||0.7|TWO_SIDED|90.0|-0.8|0.51||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew\>Neut Right VS)||0.51|-0.80|0.70
73929016|NCT01806896|147388015|SUPERIORITY_OR_OTHER||Least square mean|-0.25|STANDARD_ERROR_OF_MEAN|0.37||0.51|TWO_SIDED|90.0|-0.89|0.4||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out\_win\_Rew\>Out\_win N Left VS)||0.40|-0.89|0.51
73929017|NCT01806896|147388015|SUPERIORITY_OR_OTHER||Least square mean|-0.53|STANDARD_ERROR_OF_MEAN|0.33||0.13|TWO_SIDED|90.0|-1.1|0.04||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out\_win\_Rew\>Out\_win N Right VS)||0.04|-1.10|0.13
73929018|NCT01806896|147388018|SUPERIORITY_OR_OTHER||Least square mean|7.3|STANDARD_ERROR_OF_MEAN|3.57||0.04|TWO_SIDED|90.0|1.43|13.18||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Neutral) Day 28||13.18|1.43|0.04
73929019|NCT01806896|147388018|SUPERIORITY_OR_OTHER||Least square mean|7.57|STANDARD_ERROR_OF_MEAN|3.57||0.03|TWO_SIDED|90.0|1.69|13.45||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Positive) Day 28||13.45|1.69|0.03
73929020|NCT01806896|147388018|SUPERIORITY_OR_OTHER||Least square mean|7.28|STANDARD_ERROR_OF_MEAN|3.56||0.04|TWO_SIDED|90.0|1.41|13.15||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Negative) Day 28||13.15|1.41|0.04
73929021|NCT01806896|147388018|SUPERIORITY_OR_OTHER||Least square mean|0.98|STANDARD_ERROR_OF_MEAN|3.58||0.78|TWO_SIDED|90.0|-4.91|6.87||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.01 Euro) Day 28||6.87|-4.91|0.78
74088060|NCT02709486|147729972|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.0|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.00|<.0001
74088061|NCT02709486|147729974|SUPERIORITY||Least Square Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.33|-0.12|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.12|-0.33|<.0001
73929022|NCT01806896|147388018|SUPERIORITY_OR_OTHER||Least square mean|4.78|STANDARD_ERROR_OF_MEAN|3.58||0.18|TWO_SIDED|90.0|-1.11|10.67||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.1 Euro) Day 28||10.67|-1.11|0.18
73862746|NCT00121641|147271394|SUPERIORITY_OR_OTHER||Difference in Proportions|17.1||||0.0133|TWO_SIDED|95.0|2.8|31.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||31.0|2.8|0.0133
73929023|NCT01806896|147388018|SUPERIORITY_OR_OTHER||Least square mean|16.35|STANDARD_ERROR_OF_MEAN|3.58|<|0.01|TWO_SIDED|90.0|10.46|22.24||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-1 Euro) Day 28||22.24|10.46|<0.01
73929024|NCT02434770|147388021|EQUIVALENCE|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.84|||||TWO_SIDED|95.0|0.65|1.08|||||Lot 1 / Lot 2|||1.08|0.65|
73929025|NCT02434770|147388021|NON_INFERIORITY|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was \> 0.5.|Ratio of Geometric Mean Titers|1.08|||||TWO_SIDED|95.0|0.87|1.34|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.34|0.87|
73929026|NCT02434770|147388022|EQUIVALENCE|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.92|||||TWO_SIDED|95.0|0.73|1.15|||||Lot 1 / Lot 2|||1.15|0.73|
73929027|NCT02434770|147388022|NON_INFERIORITY|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was \> 0.5.|Ratio of Geometric Mean Titers|1.47|||||TWO_SIDED|95.0|1.21|1.79|||||BBIBP bOPV Lot 1 + Lot 2 / BioFarma bOPV|||1.79|1.21|
73929028|NCT02434770|147388023|NON_INFERIORITY|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|1.5|||||TWO_SIDED|95.0|-0.5|4.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For serotype 1||4.6|-0.5|
73929029|NCT02434770|147388023|NON_INFERIORITY|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|2.2|||||TWO_SIDED|95.0|-0.1|5.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For Serotype 3||5.6|-0.1|
73929030|NCT02434770|147388023|OTHER|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|-0.4|||||TWO_SIDED|95.0|-3.0|2.1|||||Lot 1 - Lot 2|For Serotype 1||2.1|-3.0|
73929031|NCT02434770|147388023|NON_INFERIORITY|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|0.1|||||TWO_SIDED|95.0|-2.6|2.8|||||Lot 1 - Lot 2|For Serotype 3||2.8|-2.6|
73929032|NCT02434770|147388024|NON_INFERIORITY|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be \> 0.5.|Ratio of Geometric Mean Titers|1.2|||||TWO_SIDED|95.0|0.89|1.63|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.63|0.89|
74029514|NCT01097616|147613548|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.4||||0.00298|TWO_SIDED|95.0|-12.3|-2.5||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-2.5|-12.3|0.00298
73929033|NCT02434770|147388025|OTHER||Difference in seroprotection rate|-0.09||||0.5586|TWO_SIDED|95.0|-3.86|4.48|||Fisher's exact 1-tailed test|Fisher's exact 1-tailed test of a lower rate in Lots 1+2|BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|||4.48|-3.86|0.5586
73929034|NCT02434770|147388026|NON_INFERIORITY|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be \> 0.5.|Ratio of Geometric Mean Titers|0.99|||||TWO_SIDED|95.0|0.71|1.38|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.38|0.71|
73929035|NCT00245765|147388027|SUPERIORITY||Odds Ratio (OR)|40.2|||<|0.001|TWO_SIDED|95.0|13.7|150.3|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||150.3|13.7|<0.001
73929036|NCT00245765|147388027|SUPERIORITY||Odds Ratio (OR)|73.4|||<|0.001|TWO_SIDED|95.0|23.5|292.6|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||292.6|23.5|<0.001
73929037|NCT00245765|147388028|SUPERIORITY||Odds Ratio (OR)|64.1|||<|0.001|TWO_SIDED|95.0|12.7|1169.1|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors. Confidence limits are based on likelihood ratio statistics.||||1169.1|12.7|<0.001
73929038|NCT00245765|147388028|SUPERIORITY||Odds Ratio (OR)|162.6|||<|0.001|TWO_SIDED|95.0|31.4|2999.2|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||2999.2|31.4|<0.001
73929039|NCT01966926|147388046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|chi square|2.05||||0.15|TWO_SIDED|||||P-value was unadjusted, with an a priori threshold for statistical significance set at p \<.05.|Chi-squared|1 degree of freedom||||||.15
73929040|NCT01966926|147388047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.96||||0.61||||||P-value not adjusted for multiple comparisons; a priori threshold of \<0.05 for statistical significance|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.61
73929041|NCT01966926|147388048|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.95||||0.5||||||P-value is unadjusted; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.50
73929042|NCT01966926|147388049|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.87||||0.15||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.15
73929043|NCT01966926|147388050|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.91||||0.3||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,26||Repeated measures analysis from baseline to six months.||||0.30
73929044|NCT01966926|147388051|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.93||||0.17||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 1,28||Repeated measures analysis from three to six months.||||0.17
73929045|NCT04074317|147388083|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.|||||<|0.0001||||||Least-squares geometric means for ln-transformed data.|ANOVA|||||||<0.0001
73929046|NCT04074317|147388083|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.||||||0.694|||||||ANOVA|||||||0.694
73929047|NCT04074317|147388083|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.|||||<|0.0001|||||||ANOVA|||||||<0.0001
73929048|NCT04074317|147388084|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups.|LS Mean Difference|-21.29||||0.041|TWO_SIDED|95.0|-41.23|-1.36|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||-1.36|-41.23|0.041
73929049|NCT04074317|147388084|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups.|LS Mean Difference|-7.45||||0.453|TWO_SIDED|95.0|-31.43|16.54|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||16.54|-31.43|0.453
73929050|NCT04074317|147388084|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|13.85||||0.161|TWO_SIDED|95.0|-8.46|36.15|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||36.15|-8.46|0.161
73929051|NCT04074317|147388084|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|-23.93|||<|0.001|TWO_SIDED|95.0|-35.37|-12.48|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||-12.48|-35.37|<0.001
73929052|NCT04074317|147388084|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|3.1||||0.564|TWO_SIDED|95.0|-7.8|14.0|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||14.00|-7.80|0.564
73929053|NCT04074317|147388084|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|27.03|||<|0.001|TWO_SIDED|95.0|15.96|38.09|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||38.09|15.96|<0.001
73929054|NCT04074317|147388084|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|-1.74||||0.813|TWO_SIDED|95.0|-16.7|13.22|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||13.22|-16.70|0.813
74029515|NCT01097616|147613549|SUPERIORITY_OR_OTHER||[Difference in Least Squares Means|-8.4||||0.00019|TWO_SIDED|95.0|-12.8|-4.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-4.0|-12.8|0.00019
74029516|NCT01097616|147613550|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-11.2||||2e-05|TWO_SIDED|95.0|-16.3|-6.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.1|-16.3|0.00002
74029517|NCT01097616|147613551|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-9.4||||0.00037|TWO_SIDED|95.0|-14.6|-4.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-4.3|-14.6|0.00037
73929055|NCT04074317|147388084|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|2.35||||0.73|TWO_SIDED|95.0|-11.47|16.17|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||16.17|-11.47|0.730
73929056|NCT04074317|147388084|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|4.09||||0.582|TWO_SIDED|95.0|-10.97|19.15|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||19.15|-10.97|0.582
73929057|NCT04074317|147388090|EQUIVALENCE|"Bioequivalence would require 90% confidence intervals of the geometric mean ratio to be contained within the 80-125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|37.04|||<|0.0001|TWO_SIDED|90.0|31.36|43.75||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||43.75|31.36|<0.0001
73929058|NCT04074317|147388091|OTHER||Ratio of least-square means|435.96|||<|0.0001|TWO_SIDED|||||Results of the statistical evaluation of ANOVA (alpha = 0.05) for the hypothesis of equal treatment effects.|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||<0.0001
73929059|NCT04074317|147388092|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|60.44||||0.0075|TWO_SIDED|90.0|45.41|80.43||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||80.43|45.41|0.0075
73929060|NCT04074317|147388092|EQUIVALENCE|"Bioequivalence would require 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|93.32||||0.6773|TWO_SIDED|90.0|70.14|124.16||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA|Based on Least-Squares geometric means for ln-transformed data.|"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||124.16|70.14|0.6773
73929061|NCT04074317|147388092|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|97.43||||0.8768|TWO_SIDED|90.0|72.94|130.14||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||130.14|72.94|0.8768
73929062|NCT04074317|147388093|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|53.83|||<|0.0001|TWO_SIDED|90.0|44.51|65.11||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was ana analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||65.11|44.51|<0.0001
74029518|NCT01097616|147613552|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|13.6||||7e-05|TWO_SIDED|95.0|6.9|20.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||20.3|6.9|0.00007
74029519|NCT01097616|147613552|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|21.4|||<|1e-05|TWO_SIDED|95.0|15.5|27.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||27.4|15.5|<0.00001
74088062|NCT02709486|147729974|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.0022|TWO_SIDED|95.0|-0.27|-0.06|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.27|0.0022
73929063|NCT04074317|147388093|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|73.16||||0.0192|TWO_SIDED|90.0|61.06|87.67||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||87.67|61.06|0.0192
73929064|NCT04074317|147388093|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|135.91||||0.0244|TWO_SIDED|90.0|113.1|163.31||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||163.31|113.10|0.0244
73929065|NCT04074317|147388094|OTHER||Ratio of least-square means|73.53||||0.2541|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||0.2541
73929066|NCT04074317|147388094|OTHER||Ratio of least-squares means|103.89|||>|0.9999|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||>0.9999
73929067|NCT04074317|147388094|OTHER||Ratio of least-square means|141.29||||0.1747|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||Ratio calculated as Regular Insulin least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||0.1747
73929068|NCT04074317|147388095|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|53.16|||<|0.0001|TWO_SIDED|90.0|43.59|64.83||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||64.83|43.59|<0.0001
73970292|NCT01152450|147481049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.03||0.0002||95.0|0.053|0.17|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.170|0.053|0.0002
73970293|NCT01152450|147481049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.074|0.191|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.191|0.074|<0.0001
73862747|NCT00121641|147271395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6221.0|STANDARD_ERROR_OF_MEAN|1701.3||0.0003|TWO_SIDED|95.0|-9570.0|-2872.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-2872|-9570|0.0003
73862748|NCT00121641|147271395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6249.0|STANDARD_ERROR_OF_MEAN|1675.1||0.0002|TWO_SIDED|95.0|-9546.0|-2952.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-2952|-9546|0.0002
73929069|NCT04074317|147388095|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|65.24||||0.0018|TWO_SIDED|90.0|54.02|78.8||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||78.80|54.02|0.0018
73929070|NCT04074317|147388095|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|122.73||||0.2391|TWO_SIDED|90.0|101.33|148.66||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||148.66|101.33|0.2391
73929071|NCT04074317|147388095|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|54.2|||<|0.0001|TWO_SIDED|90.0|47.58|61.73||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||61.73|47.58|<0.0001
73929072|NCT04074317|147388095|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|71.29||||0.0002|TWO_SIDED|90.0|62.99|80.69||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||80.69|62.99|0.0002
73929073|NCT04074317|147388095|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|131.55||||0.0026|TWO_SIDED|90.0|116.01|149.17||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||149.17|116.01|0.0026
73970294|NCT01152450|147481049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.03||||95.0|-0.037|0.08|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.080|-0.037|
73970295|NCT01152450|147481050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.035||0.0515||95.0|0.0|0.136|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.136|0.000|0.0515
73970296|NCT01152450|147481050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.035||0.1058||95.0|-0.012|0.124|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.124|-0.012|0.1058
73970297|NCT01152450|147481050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.035||||95.0|-0.08|0.057|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.057|-0.080|
73970298|NCT01152450|147481051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.073|0.177|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.177|0.073|<0.0001
74088063|NCT02709486|147729974|SUPERIORITY||Least Square Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.35|-0.14|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.35|<.0001
73929074|NCT04074317|147388095|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|51.34|||<|0.0001|TWO_SIDED|90.0|46.74|56.39||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||56.39|46.74|<0.0001
73862749|NCT00121641|147271395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7437.0|STANDARD_ERROR_OF_MEAN|1707.6|<|0.0001|TWO_SIDED|95.0|-10798.0|-4076.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-4076|-10798|<.0001
73862750|NCT01014455|147271439|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||t-test, 2 sided|||||||0.672
73929075|NCT04074317|147388095|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|78.24||||0.0003|TWO_SIDED|90.0|71.39|85.76||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||85.76|71.39|0.0003
73929076|NCT04074317|147388095|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|152.41|||<|0.0001|TWO_SIDED|90.0|138.91|167.22||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||167.22|138.91|<0.0001
73929077|NCT01101841|147388096|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA|||||||<0.0001
73929078|NCT01101841|147388096|SUPERIORITY_OR_OTHER|||||||0.0001||||||Week 12 frequency|Rank transformed ANCOVA|||||||0.0001
73929079|NCT01101841|147388097|SUPERIORITY_OR_OTHER|||||||0.0066||||||Week 24 persistence of effect|Logit model|||||||0.0066
73929080|NCT01101841|147388112|SUPERIORITY_OR_OTHER|||||||0.0368||||||Week 4 severity|Rank transformed ANCOVA|||||||0.0368
73929081|NCT01101841|147388112|SUPERIORITY_OR_OTHER|||||||0.0064||||||Week 12 severity|Rank transformed ANCOVA|||||||0.0064
73929082|NCT00653224|147388119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.33|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.33|<0.001
73929083|NCT00653224|147388120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.52|<0.001
73929084|NCT00653224|147388121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|||<|0.001||95.0|-0.47|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.15|-0.47|<0.001
73929085|NCT00653224|147388122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.52|<0.001
73929086|NCT00653224|147388123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.042||95.0|-0.49|-0.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.01|-0.49|0.042
73929087|NCT00653224|147388124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.014||95.0|-0.52|-0.06||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.52|0.014
73929088|NCT00653224|147388125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.036||95.0|-0.51|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.02|-0.51|0.036
73929089|NCT00653224|147388126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.01||95.0|-0.48|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.07|-0.48|0.010
73929090|NCT00653224|147388127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.026||95.0|-0.43|-0.03||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.03|-0.43|0.026
73929091|NCT00653224|147388128|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25||||0.018||95.0|-0.45|-0.04||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.04|-0.45|0.018
73970299|NCT01152450|147481051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.026||0.0002||95.0|0.048|0.152|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.152|0.048|0.0002
73970300|NCT01152450|147481051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.077|0.027|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.027|-0.077|
73970301|NCT01152450|147481052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.027||0.0051||95.0|0.023|0.129|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.129|0.023|0.0051
73970302|NCT01152450|147481052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.027||0.0123||95.0|0.015|0.12|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.120|0.015|0.0123
73970303|NCT01152450|147481052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.027||||95.0|-0.061|0.045|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.045|-0.061|
73862751|NCT01184417|147271454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|||||TWO_SIDED|95.0|4.0|32.0||||||||32|4|
73929092|NCT00653224|147388129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.002||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.47|0.002
73929093|NCT00653224|147388130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.006||95.0|-0.41|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.07|-0.41|0.006
73970304|NCT01152450|147481053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.027||0.0042||95.0|0.025|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.130|0.025|0.0042
73970305|NCT01152450|147481053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.027||0.0747||95.0|-0.005|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.100|-0.005|0.0747
74029520|NCT01097616|147613553|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|16.3||||0.00016|TWO_SIDED|95.0|7.9|24.8|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||24.8|7.9|0.00016
74029521|NCT01097616|147613554|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|10.7||||0.01711|TWO_SIDED|95.0|1.9|19.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||19.5|1.9|0.01711
74029522|NCT01097616|147613555|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-32.5|||<|1e-05|TWO_SIDED|95.0|-39.3|-25.7|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-25.7|-39.3|<0.00001
74029523|NCT01097616|147613555|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-38.4|||<|1e-05|TWO_SIDED|95.0|-44.5|-32.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-32.3|-44.5|<0.00001
74029524|NCT01097616|147613556|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-26.4|||<|1e-05|TWO_SIDED|95.0|-34.3|-18.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-18.4|-34.3|<0.00001
74029525|NCT01097616|147613557|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.6||||9e-05|TWO_SIDED|95.0|-24.8|-8.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-8.3|-24.8|0.00009
74029526|NCT01097616|147613558|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.6||||0.01564|TWO_SIDED|95.0|-10.2|-1.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-1.1|-10.2|0.01564
74029527|NCT01097616|147613558|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.7||||0.00609|TWO_SIDED|95.0|-9.7|-1.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-1.6|-9.7|0.00609
73970306|NCT01152450|147481053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.027||||95.0|-0.082|0.023|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.023|-0.082|
73970307|NCT01152450|147481057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.055|0.147|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.147|0.055|<0.0001
73970308|NCT01152450|147481057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.023||0.0004||95.0|0.038|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.130|0.038|0.0004
73862752|NCT01184417|147271455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||||TWO_SIDED|95.0|4.0|49.0||||||||49|4|
73862753|NCT01184417|147271456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.0|||||TWO_SIDED|95.0|-4.0|82.0||||||||82|-4|
73862754|NCT01184417|147271458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-11.0|23.0||||||||23|-11|
73862755|NCT01355796|147271474|SUPERIORITY||Mean Difference (Net)|1.49|STANDARD_ERROR_OF_MEAN|1.66|<|0.05|TWO_SIDED|95.0|-1.76|4.75|||Mixed Models Analysis|||||4.75|-1.76|<0.05
73862756|NCT04728594|147271490|SUPERIORITY||Odds Ratio (OR)|2.11|||<|0.001|TWO_SIDED|95.0|1.65|2.69||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||2.69|1.65|<.001
73862757|NCT04728594|147271490|SUPERIORITY||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.77|2.87||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||2.87|1.77|<.001
73862758|NCT04728594|147271490|SUPERIORITY||Odds Ratio (OR)|1.07|||<|0.001|TWO_SIDED|95.0|0.88|1.3||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||1.30|0.88|<.001
73862759|NCT00128713|147271512|SUPERIORITY_OR_OTHER|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.83
73862760|NCT00128713|147271512|SUPERIORITY_OR_OTHER|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.83
73862761|NCT00128713|147271512|SUPERIORITY_OR_OTHER|||||||0.66||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.66
73862762|NCT00128713|147271513|SUPERIORITY_OR_OTHER|||||||0.02||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.02
73862763|NCT00128713|147271513|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
73929094|NCT00653224|147388131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.003||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.47|0.003
73970309|NCT01152450|147481057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.023||||95.0|-0.063|0.03|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.030|-0.063|
73862764|NCT00128713|147271513|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
73862765|NCT00128713|147271514|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
73862766|NCT00128713|147271514|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
73862767|NCT00128713|147271514|SUPERIORITY_OR_OTHER|||||||0.16||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.16
73862768|NCT00128713|147271516|SUPERIORITY_OR_OTHER|||||||0.51||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.51
73862769|NCT00128713|147271516|SUPERIORITY_OR_OTHER|||||||0.82||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.82
73862770|NCT00128713|147271516|SUPERIORITY_OR_OTHER|||||||0.68||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.68
73862771|NCT01264770|147271517|SUPERIORITY_OR_OTHER||Treatment difference|0.56||||0.006|TWO_SIDED|90.0|0.23|0.9|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.90|0.23|0.006
73970310|NCT01152450|147481058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.242|STANDARD_ERROR_OF_MEAN|4.091|<|0.0001||95.0|22.167|38.317|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||38.317|22.167|<0.0001
73862772|NCT01264770|147271517|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.022|TWO_SIDED|90.0|0.14|0.84|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.84|0.14|0.022
73929095|NCT00653224|147388132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.61|<0.001
73929096|NCT00653224|147388133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||<|0.001||95.0|-0.57|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-0.57|<0.001
73929097|NCT00653224|147388134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.61|<0.001
73929098|NCT00653224|147388135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.59|<0.001
73929099|NCT00653224|147388136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.001||95.0|-0.55|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-0.55|<0.001
73970311|NCT01152450|147481058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.31|STANDARD_ERROR_OF_MEAN|4.089|<|0.0001||95.0|26.24|42.38|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||42.380|26.240|<0.0001
73970312|NCT01152450|147481058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.068|STANDARD_ERROR_OF_MEAN|4.094||||95.0|-4.012|12.148|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||12.148|-4.012|
73929100|NCT00653224|147388137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.59|<0.001
73970313|NCT01152450|147481059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.769||0.6747||95.0|-1.195|1.841|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||1.841|-1.195|0.6747
73970314|NCT01152450|147481059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.389|STANDARD_ERROR_OF_MEAN|0.774||0.6159||95.0|-1.138|1.916|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||1.916|-1.138|0.6159
73970315|NCT01152450|147481059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.777||||95.0|-1.468|1.599|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||1.599|-1.468|
73970316|NCT01152450|147481060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.142||0.5906||95.0|-0.358|0.204|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.204|-0.358|0.5906
73970317|NCT01152450|147481060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.143||0.2208||95.0|-0.458|0.106|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.106|-0.458|0.2208
73929101|NCT00653224|147388138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.21|-0.63|<0.001
73970318|NCT01152450|147481060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.143||||95.0|-0.382|0.184|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.184|-0.382|
74088064|NCT02709486|147729974|SUPERIORITY||Least Square Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.43|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.43|<.0001
73929102|NCT00653224|147388139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.001||95.0|-0.56|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.56|<0.001
73929103|NCT00653224|147388140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.22|-0.63|<0.001
73929104|NCT00653224|147388141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|||<|0.001||95.0|-0.53|-0.13||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.13|-0.53|<0.001
73929105|NCT00653224|147388142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.15|-0.52|<0.001
73929106|NCT00653224|147388143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.53|-0.14||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.14|-0.53|<0.001
73929107|NCT00653224|147388144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.32|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T5SS over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.32|<0.001
73970319|NCT01152450|147481061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.082||0.9797||95.0|-0.163|0.159|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.159|-0.163|0.9797
73970320|NCT01152450|147481061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.082||0.4518||95.0|-0.223|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.100|-0.223|0.4518
73970321|NCT01152450|147481061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.082||||95.0|-0.222|0.102|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.102|-0.222|
73970322|NCT01152450|147481062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.074||0.4089||95.0|-0.207|0.085|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.085|-0.207|0.4089
73970323|NCT01152450|147481062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.074|STANDARD_ERROR_OF_MEAN|0.074||0.3185||95.0|-0.221|0.072|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.072|-0.221|0.3185
73929108|NCT00653224|147388145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001||95.0|-1.39|-0.36||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T5SS over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.36|-1.39|<0.001
73929109|NCT00653224|147388146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.001||95.0|-1.2|-0.49||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.49|-1.20|<0.001
73929110|NCT00653224|147388147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|||<|0.001||95.0|-1.18|-0.35||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.35|-1.18|<0.001
73929111|NCT00653224|147388148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.001||95.0|-1.17|-0.45||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.17|<0.001
73929112|NCT00653224|147388149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.17|-0.31||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.31|-1.17|<0.001
73929113|NCT00653224|147388150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.005||95.0|-1.26|-0.22||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.22|-1.26|0.005
73929114|NCT00653224|147388151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.18|-0.3||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.30|-1.18|<0.001
73970324|NCT01152450|147481062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.074||||95.0|-0.16|0.134|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.134|-0.160|
73970325|NCT01152450|147481063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031||0.9626||95.0|-0.059|0.062|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.062|-0.059|0.9626
73970326|NCT01152450|147481063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.031||0.9102||95.0|-0.058|0.065|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.065|-0.058|0.9102
73929115|NCT00653224|147388152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001||95.0|-0.87|-0.3||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.30|-0.87|<0.001
73970327|NCT01152450|147481063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.031||||95.0|-0.059|0.063|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.063|-0.059|
73929116|NCT00653224|147388153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.91|-0.24||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.24|-0.91|<0.001
73929117|NCT00653224|147388154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.86|-0.28||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.28|-0.86|<0.001
73929118|NCT00653224|147388155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.34|-0.13||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.13|-0.34|<0.001
73929119|NCT00653224|147388156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.09||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.09|-0.34|<0.001
73929120|NCT00653224|147388157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.33|-0.12||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.12|-0.33|<0.001
73929121|NCT00653224|147388158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.11||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.11|-0.32|<0.001
73929122|NCT00653224|147388159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.008||95.0|-0.3|-0.05||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.30|0.008
73929123|NCT00653224|147388160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.09||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.09|-0.30|<0.001
73929124|NCT00653224|147388161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.384||95.0|-0.15|0.06||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.06|-0.15|0.384
73970328|NCT05778695|147481064|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Median Difference (Net)|-14.0|STANDARD_DEVIATION|22.02||0.875|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.875
73970329|NCT05778695|147481064|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Mean Difference (Net)|-2.0|STANDARD_DEVIATION|15.166||0.739|TWO_SIDED|95.0|-16.026|12.026||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|||||12.026|-16.026|0.739
73970330|NCT05778695|147481065|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Median Difference (Net)|0.0|STANDARD_DEVIATION|0.34||0.37|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.37
73970331|NCT01799265|147481090|NON_INFERIORITY|The 95% upper limit of the prediction interval was calculated using the formula (μ ) ̂+t\_(k-2)\^α √((τ\^2 ) ̂+〖(SE) ̂(μ ̂ )〗\^2 ),where (μ ) ̂is the estimate average AHI across all studies, (τ\^2 ) ̂ is the between-study variation, t\_(k-2)\^α is the critical value for a t-distribution, k is the number of studies in the meta-analysis, and k-2 are the degrees of freedom for the t distribution. Meta-analyzed statistics to compute the prediction interval were (μ ) ̂=5.0, SE(μ ̂ )=0.9, and (τ\^2 ) ̂=8.0||||||0.05|||||||t-test, 1 sided|A p-value of .05 was used.||"Hypothesis testing for the primary endpoint was conducted using a one-sided test of non-inferiority with the following null and alternative hypotheses at the 0.05 significance level using the MIXED procedure in SAS, version 9.3:~H\_0:(ϕ\_m ) ̂≥6.9 H\_A:(ϕ\_m ) ̂\<6.9 where (ϕ\_m ) ̂ is the estimated AHI difference between Transcend Auto and REMstar Auto from the model described in 3.5.1."||||.05
73970332|NCT03381196|147481101|SUPERIORITY|||||||0.0216|||||||Gehan-Wilcoxon test|||||||0.0216
73970333|NCT05260112|147481110|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73970334|NCT05260112|147481111|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73970335|NCT05260112|147481112|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73970336|NCT05260112|147481113|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73929125|NCT00653224|147388162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.063||95.0|-0.24|0.01||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.24|0.063
73929126|NCT00653224|147388163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.124||95.0|-0.19|0.02||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.02|-0.19|0.124
73970337|NCT05260112|147481114|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
73970338|NCT05260112|147481115|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73970339|NCT06019559|147481116|SUPERIORITY|||||||0.0756||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|MMRM model with gender, treatment, visit and treatment-by-visit interaction as fixed effect, and baseline body weight as a covariate.||||||0.0756
73929127|NCT00653224|147388164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.002||95.0|-0.28|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.28|0.002
73929128|NCT00653224|147388165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.016||95.0|-0.28|-0.03||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.03|-0.28|0.016
74029528|NCT01097616|147613559|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.4||||0.05191|TWO_SIDED|95.0|-10.9|0.0|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||0.0|-10.9|0.05191
74029529|NCT01097616|147613560|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.2||||0.03771|TWO_SIDED|95.0|-10.2|-0.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-0.3|-10.2|0.03771
73929129|NCT00653224|147388166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.003||95.0|-0.27|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.27|0.003
73929130|NCT00653224|147388167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.088||95.0|-0.2|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.20|0.088
73929131|NCT00653224|147388168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.117||95.0|-0.23|0.03||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.03|-0.23|0.117
73929132|NCT00653224|147388169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.065||95.0|-0.21|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.21|0.065
73929133|NCT00653224|147388170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.32|<0.001
73929134|NCT00653224|147388171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.002||95.0|-0.33|-0.08||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.33|0.002
73929135|NCT00653224|147388172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.32|<0.001
73862773|NCT01264770|147271517|SUPERIORITY_OR_OTHER||Treatment difference|0.22||||0.28|TWO_SIDED|90.0|-0.12|0.56|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.56|-0.12|0.280
73929136|NCT00653224|147388173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.30|<0.001
73929137|NCT00653224|147388174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.006||95.0|-0.29|-0.05||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.29|0.006
73929138|NCT00653224|147388175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
73929139|NCT00653224|147388176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||<|0.001||95.0|-0.31|-0.1||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.31|<0.001
73929140|NCT00653224|147388177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.011||95.0|-0.29|-0.04||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.04|-0.29|0.011
73970340|NCT06019559|147481116|SUPERIORITY|||||||0.0008||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|(MMRM) model with gender, treatment, visit and treatment-by-visit interaction as fixed effect, and baseline body weight as a covariate.||For the primary endpoint of percentage change from baseline in body weight, a sample size of 150 participants (stratified by gender and randomized 1:1:1 into three treatment arms) provided \>95% power to detect a treatment difference of 4% weight reduction after 13 weeks of treatment with a 2-sided alpha of 0.05, assuming a standard deviation of 4% and 20% drop out.||||0.0008
73970341|NCT06019559|147481117|SUPERIORITY|||||||0.8366||||||The threshold for significance was p = 0.05.|Regression, Logistic|||||||0.8366
73970342|NCT06019559|147481117|SUPERIORITY|||||||0.1848||||||The threshold for significance was p = 0.05.|Regression, Logistic|||||||0.1848
73970343|NCT06019559|147481118|SUPERIORITY|||||||0.0616||||||The threshold for significance was p = 0.05.|Mixed Models Analysis|||||||0.0616
73929141|NCT00653224|147388178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
73970344|NCT06019559|147481118|SUPERIORITY|||||||0.0004||||||The threshold for significance was p = 0.05.|Mixed Models Analysis|||||||0.0004
73970345|NCT01574274|147481185|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73970346|NCT01574274|147481186|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Day 4 NSAA Level||||0.07
73970347|NCT01574274|147481186|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Day 11 NSAA Level||||0.29
73970348|NCT01574274|147481186|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||Day 18 NSAA Level||||0.0002
73970349|NCT01574274|147481186|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Day 25 NSAA Level||||<0.0001
73970350|NCT01574274|147481186|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Week 7 NSAA Level||||<0.0001
73970351|NCT01574274|147481186|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Week 13 NSAA Level||||0.87
73970352|NCT01574274|147481186|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Week 19 NSAA Level||||0.83
73970353|NCT01574274|147481186|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Week 25 NSAA Level||||0.94
73970354|NCT01814813|147481194|SUPERIORITY|||||||0.16|||||||Log Rank|||||||0.16
73970355|NCT01814813|147481195|SUPERIORITY||||||<|0.01|||||||Log Rank|||||||<0.01
73970356|NCT01814813|147481196|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
73970357|NCT05089019|147481197|EQUIVALENCE|Equivalence margin 80% to 125%|Ratio of Geometric LS Mean|0.889|||||TWO_SIDED|94.12|0.81|0.976|||Mixed Models Analysis|Ratio of Geometric Least Square (LS) Mean||||0.976|0.810|
73929142|NCT00653224|147388179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.004||95.0|-0.27|-0.05||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.27|0.004
73970358|NCT05089019|147481198|EQUIVALENCE|Equivalence margin 80% to 125%.|Ratio of Geometric LS Mean|0.927|||||TWO_SIDED|94.12|0.882|0.975|||Mixed Models Analysis|||||0.975|0.882|
73970359|NCT05089019|147481199|EQUIVALENCE|Equivalence margin 80% to 125%|Ratio of Geometric LS Mean|0.891|||||TWO_SIDED|94.12|0.834|0.951|||Mixed Models Analysis|||||0.951|0.834|
73970360|NCT03858634|147481200|SUPERIORITY||Least squares (LS) mean difference|-3.3|STANDARD_ERROR_OF_MEAN|3.31||0.398|TWO_SIDED|80.0|-8.68|2.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||2.17|-8.68|0.3980
73970361|NCT03858634|147481200|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|1.23||0.6653|TWO_SIDED|80.0|-2.17|1.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||1.09|-2.17|0.6653
73970362|NCT03858634|147481200|SUPERIORITY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.14||0.0711|TWO_SIDED|80.0|-11.63|-3.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-3.56|-11.63|0.0711
73970363|NCT03858634|147481200|SUPERIORITY||LS mean difference|-3.1|STANDARD_ERROR_OF_MEAN|1.2||0.0186|TWO_SIDED|80.0|-4.7|-1.51||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-1.51|-4.70|0.0186
73929143|NCT00653224|147388180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.1||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.34|<0.001
73929144|NCT00653224|147388181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
73929145|NCT00653224|147388182|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test is generally used to detect 'shift alternatives'. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.||||<0.001
73929146|NCT00653224|147388183|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test (Lehmann, 1975 page 23) is generally used to detect 'shift alternatives'. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.||||<0.001
73929147|NCT00653224|147388184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.027||95.0|-2.56|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-2.56|0.027
73929148|NCT00653224|147388185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.554||95.0|-1.56|0.84||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.84|-1.56|0.554
73929149|NCT00653224|147388186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.015||95.0|-2.72|-0.29||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.29|-2.72|0.015
73929150|NCT00653224|147388187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.016||95.0|-8.34|-0.86||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.86|-8.34|0.016
74088065|NCT02709486|147729974|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.0029|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.28|0.0029
73929151|NCT00653224|147388188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33||||0.017||95.0|-7.88|-0.79||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.79|-7.88|0.017
73929152|NCT00653224|147388189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.25||||0.027||95.0|-8.02|-0.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.47|-8.02|0.027
73929153|NCT00653224|147388190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44||||0.023||95.0|-8.25|-0.63||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.63|-8.25|0.023
73929154|NCT00653224|147388191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.56||||0.015||95.0|-8.23|-0.89||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.89|-8.23|0.015
73929155|NCT00653224|147388192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.11||||0.036||95.0|-7.95|-0.27||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.27|-7.95|0.036
73970364|NCT03858634|147481202|SUPERIORITY||LS mean difference|-7.3|STANDARD_ERROR_OF_MEAN|14.76||0.6533|TWO_SIDED|80.0|-31.52|16.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||16.84|-31.52|0.6533
73970365|NCT03858634|147481202|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|10.51||0.9077|TWO_SIDED|80.0|-15.16|12.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||12.69|-15.16|0.9077
73970366|NCT03858634|147481202|SUPERIORITY||LS mean difference|-61.2|STANDARD_ERROR_OF_MEAN|33.18||0.2065|TWO_SIDED|80.0|-123.73|1.39||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||1.39|-123.73|0.2065
73970367|NCT03858634|147481202|SUPERIORITY||LS mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.19||0.1133|TWO_SIDED|80.0|-9.56|-1.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-1.07|-9.56|0.1133
73929156|NCT00653224|147388193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51||||0.102||95.0|-9.95|0.93||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.93|-9.95|0.102
73929157|NCT00653224|147388194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.493||95.0|-5.66|2.78||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||2.78|-5.66|0.493
73970368|NCT03858634|147481202|SUPERIORITY||LS mean difference|-16.7|STANDARD_ERROR_OF_MEAN|21.76||0.4997|TWO_SIDED|80.0|-52.29|18.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||18.98|-52.29|0.4997
73970369|NCT03858634|147481202|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|11.85||0.9919|TWO_SIDED|80.0|-15.83|15.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||15.59|-15.83|0.9919
73929158|NCT00653224|147388195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38||||0.117||95.0|-9.91|1.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||1.15|-9.91|0.117
73929159|NCT00653224|147388196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.58||||0.409||95.0|-15.65|6.49||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||6.49|-15.65|0.409
73929160|NCT00653224|147388197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.54||||0.432||95.0|-16.1|7.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||7.01|-16.10|0.432
73929161|NCT00653224|147388198|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.24||||0.45||95.0|-15.46|6.99||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||6.99|-15.46|0.450
73929162|NCT00653224|147388199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.37||||0.251||95.0|-17.4|4.67||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||4.67|-17.40|0.251
73929163|NCT00653224|147388200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.06||||0.258||95.0|-19.48|5.36||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||5.36|-19.48|0.258
73929164|NCT00653224|147388201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.96||||0.288||95.0|-17.13|5.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||5.22|-17.13|0.288
73929165|NCT00653224|147388202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.91|||<|0.001||95.0|-9.34|-2.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-2.47|-9.34|<0.001
73929166|NCT00653224|147388203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.62|||<|0.001||95.0|-9.88|-3.35||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-3.35|-9.88|<0.001
73929167|NCT00653224|147388204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69||||0.001||95.0|-9.16|-2.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-2.21|-9.16|0.001
73929168|NCT00653224|147388205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.027||95.0|-1.29|-0.08||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-1.29|0.027
74029530|NCT01097616|147613563|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-9.6||||0.00041|TWO_SIDED|95.0|-14.9|-4.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-4.3|-14.9|0.00041
73929169|NCT00653224|147388206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.535||95.0|-0.7|0.37||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.37|-0.70|0.535
73929170|NCT00653224|147388207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.042||95.0|-1.26|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.02|-1.26|0.042
73929171|NCT00653224|147388208|SUPERIORITY_OR_OTHER|||||||0.171||95.0||||If the p-value of this estimated difference is lower than 5% the change from baseline is considered as different between the two treatment groups.|Repeated measure analysis (CATMOD)|||The Null Hypothesis is expressed as follows: 'The change from baseline to endpoint visit in score category (ESS score \< 8 or \>= 8) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||||0.171
73970370|NCT03858634|147481202|SUPERIORITY||LS mean difference|-89.2|STANDARD_ERROR_OF_MEAN|28.56||0.0891|TWO_SIDED|80.0|-143.03|-35.31||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-35.31|-143.03|0.0891
73970371|NCT03858634|147481202|SUPERIORITY||LS mean difference|-9.4|STANDARD_ERROR_OF_MEAN|5.47||0.1029|TWO_SIDED|80.0|-16.67|-2.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-2.12|-16.67|0.1029
74088066|NCT02709486|147729974|SUPERIORITY||Least Square Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.37|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.37|<.0001
74088067|NCT02709486|147729974|SUPERIORITY||Least Square Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.4|-0.17|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.40|<.0001
73929172|NCT00640510|147388228|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||A sample size of at least 15 patients per group was necessary to verify that the decrease in PANSS-EC total score was significantly greater in the IM olanzapine group than the placebo group using Student's t-test with a power of 90% at a two-sided significance level of 5%.||||0.940
73970372|NCT03858634|147481202|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|32.93||0.5538|TWO_SIDED|80.0|-75.82|32.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||32.05|-75.82|0.5538
73929173|NCT00640510|147388229|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Change from Baseline to 15 minutes. Change = Timepoint minus Baseline.|t-test, 2 sided|||||||1.000
73929174|NCT00640510|147388229|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-value for Change from Baseline to 30 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.620
73929175|NCT00640510|147388229|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-value for Change from Baseline to 60 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.784
73929176|NCT00640510|147388229|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value for Change from Baseline to 90 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.756
73929177|NCT00640510|147388230|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
73929178|NCT00640510|147388231|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 30 Minutes.|Fisher Exact|||||||1.000
73929179|NCT00640510|147388231|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 60 Minutes.|Fisher Exact|||||||1.000
73970373|NCT03858634|147481202|SUPERIORITY||LS mean difference|-11.9|STANDARD_ERROR_OF_MEAN|11.78||0.3252|TWO_SIDED|80.0|-27.51|3.73||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||3.73|-27.51|0.3252
73970374|NCT03858634|147481202|SUPERIORITY||LS mean difference|-93.8|STANDARD_ERROR_OF_MEAN|34.1||0.1106|TWO_SIDED|80.0|-158.11|-29.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-29.52|-158.11|0.1106
73929180|NCT00640510|147388231|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 90 Minutes.|Fisher Exact|||||||1.000
73929181|NCT00640510|147388231|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 2 Hours.|Fisher Exact|||||||1.000
73929182|NCT01956110|147388259|NON_INFERIORITY|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing pregnancy rate was demonstrated.|Treatment difference|-0.9|||||TWO_SIDED|95.0|-5.9|4.1||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% confidence interval (CI) derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.1|-5.9|
73929183|NCT01956110|147388260|NON_INFERIORITY|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing implantation rate was demonstrated.|Treatment difference|-0.6|||||TWO_SIDED|95.0|-6.1|4.8||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.8|-6.1|
73929184|NCT01956110|147388261|NON_INFERIORITY|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.7|3.4||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||3.4|-6.7|
73970375|NCT03858634|147481202|SUPERIORITY||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|7.17||0.0123|TWO_SIDED|80.0|-29.48|-10.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-10.40|-29.48|0.0123
73970376|NCT03858634|147481202|SUPERIORITY||LS mean difference|-28.9|STANDARD_ERROR_OF_MEAN|35.86||0.4791|TWO_SIDED|80.0|-87.63|29.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||29.81|-87.63|0.4791
73970377|NCT03858634|147481202|SUPERIORITY||LS mean difference|-5.5|STANDARD_ERROR_OF_MEAN|12.66||0.6684|TWO_SIDED|80.0|-22.28|11.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||11.27|-22.28|0.6684
74029531|NCT01097616|147613563|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3||||2e-05|TWO_SIDED|95.0|-15.0|-5.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-5.5|-15.0|0.00002
73929185|NCT01956110|147388262|NON_INFERIORITY|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.4|||||TWO_SIDED|95.0|-7.0|4.2||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.2|-7.0|
73929186|NCT01956110|147388263|OTHER|A logistic regression model was fitted to the data including AMH, log(AMH)\^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor.|||||=|0.001||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: \<4 or \>=15 oocytes retrieved||||=0.001
73929187|NCT01956110|147388263|OTHER|A logistic regression model was fitted to the data including AMH, log(AMH)2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor.|||||=|0.002||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: \<4 or \>=20 oocytes retrieved||||=0.002
73929188|NCT01956110|147388264|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.291||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade)||||=0.291
73970378|NCT03858634|147481202|SUPERIORITY||LS mean difference|-79.7|STANDARD_ERROR_OF_MEAN|26.28||0.0937|TWO_SIDED|80.0|-129.22|-30.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-30.13|-129.22|0.0937
73970379|NCT03858634|147481202|SUPERIORITY||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|9.75||0.012|TWO_SIDED|80.0|-40.21|-14.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-14.27|-40.21|0.0120
73970380|NCT03858634|147481202|SUPERIORITY||LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|41.95||0.4927|TWO_SIDED|80.0|-101.39|36.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||36.02|-101.39|0.4927
73929189|NCT01956110|147388264|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.644||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe)||||=0.644
74029532|NCT01097616|147613564|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3||||0.0004|TWO_SIDED|95.0|-16.0|-4.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-4.6|-16.0|0.00040
73929190|NCT01956110|147388264|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.005||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Preventive interventions||||=0.005
73929191|NCT01956110|147388264|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.046||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade) and/or preventive interventions||||=0.046
73929192|NCT01956110|147388264|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.019||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe) and/or preventive interventions||||=0.019
73929193|NCT01956110|147388265|EQUIVALENCE|Treatment groups were compared using a logistic regression model with treatment and age (\<35, 35- 37, and 38-40 years) as factors.|Odds Ratio (OR)|1.38|||=|0.302|TWO_SIDED|95.0|0.74|2.57||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison: Cycle cancelled due to poor response||2.57|0.74|=0.302
74088068|NCT02709486|147729974|SUPERIORITY||Least Square Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.43|-0.2|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-0.43|<.0001
74088069|NCT02709486|147729974|SUPERIORITY||Least Square Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0352|TWO_SIDED|95.0|-0.26|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.01|-0.26|0.0352
74088070|NCT02709486|147729974|SUPERIORITY||Least Square Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.37|-0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.13|-0.37|<.0001
73929194|NCT01956110|147388265|EQUIVALENCE|Treatment groups were compared using a logistic regression model with treatment and age (\<35, 35-37, and 38-40 years) as factors.|Odds Ratio (OR)|0.42||||0.019|TWO_SIDED|95.0|0.2|0.9||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison:Triggering with GnRH agonist||0.9|0.2|0.019
73929195|NCT01956110|147388266|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.692|||||||van Elteren|||Treatment comparison: Number of oocytes retrieved||||=0.692
73929196|NCT01956110|147388267|OTHER|"A logistic regression model was fitted to the data including AMH, log(AMH)\^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor.~A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor."|||||=|0.019||||||Inclusion of treatment provides a better fit to the data|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||The relation between ovarian response potential (AMH at screening) and probability of achieving the targeted response was modelled using logistic regression models.||||=0.019
73929197|NCT01956110|147388268|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.909|||||||van Elteren|||Treatment comparison: Number of metaphase II oocytes||||=0.909
73929198|NCT01956110|147388269|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).||||||0.53|||||||van Elteren|||Treatment comparison: Fertilisation rate||||0.53
73929199|NCT01956110|147388270|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.59|||||||van Elteren|||Treatment comparison: Number of embryos||||=0.59
73929200|NCT01956110|147388270|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.414|||||||van Elteren|||Treatment comparison: Good quality embryos||||=0.414
73929201|NCT01956110|147388271|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.344|||||||van Elteren|||Treatment comparison: Number of blastocysts||||= 0.344
73929202|NCT01956110|147388271|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.58|||||||van Elteren|||Treatment comparison: Good-quality blastocysts||||= 0.58
73929203|NCT01956110|147388272|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||<|0.001|||||||van Elteren|||Treatment comparison: Total gonadotropin dose||||<0.001
73929204|NCT01956110|147388273|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.062|||||||van Elteren|||Treatment comparison: Number of stimulation days||||=0.062
73970381|NCT03858634|147481202|SUPERIORITY||LS mean difference|-10.9|STANDARD_ERROR_OF_MEAN|13.9||0.4409|TWO_SIDED|80.0|-29.35|7.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||7.49|-29.35|0.4409
73970382|NCT03858634|147481202|SUPERIORITY||LS mean difference|-90.7|STANDARD_ERROR_OF_MEAN|34.58||0.1197|TWO_SIDED|80.0|-155.96|-25.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-25.54|-155.96|0.1197
74029533|NCT01097616|147613565|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-8.1||||0.00606|TWO_SIDED|95.0|-13.8|-2.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-2.3|-13.8|0.00606
74029534|NCT01703819|147613573|SUPERIORITY_OR_OTHER|||||||0.7726||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.7726
73929205|NCT01956110|147388274|EQUIVALENCE|Treatment groups were compared using a chi-square test.|||||=|0.178|||||||Chi-squared|||Treatment comparison: Investigator-requested gonadotropin dose adjustments||||=0.178
73929206|NCT01956110|147388280|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.32||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (any grade)||||0.320
73929207|NCT01956110|147388280|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.39||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (moderate/severe)||||0.390
73929208|NCT04027218|147388354|SUPERIORITY||Odds Ratio (OR)|2.57||||0.001|TWO_SIDED|95.0|2.34|2.79|||McNemar|||||2.79|2.34|0.001
73929209|NCT04027218|147388354|SUPERIORITY||Odds Ratio (OR)|1.92||||0.002|TWO_SIDED|95.0|1.7|2.13|||McNemar|||||2.13|1.70|0.002
73929210|NCT04027218|147388354|SUPERIORITY||Odds Ratio (OR)|1.9||||0.004|TWO_SIDED|95.0|1.87|1.92|||McNemar|||||1.92|1.87|0.004
73929211|NCT04027218|147388355|SUPERIORITY||Median Difference (Net)|-4.179||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
73929212|NCT04027218|147388355|SUPERIORITY||Median Difference (Net)|-3.619||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
73929213|NCT04027218|147388355|SUPERIORITY||Median Difference (Net)|-4.099||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
73929214|NCT04027218|147388356|SUPERIORITY||Median Difference (Net)|-1.073||||0.863|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.863
73929215|NCT04027218|147388356|SUPERIORITY||Median Difference (Net)|-1.267||||0.205|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.205
73929216|NCT04027218|147388356|SUPERIORITY||Median Difference (Net)|-0.858||||0.391|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.391
73929217|NCT04027218|147388358|SUPERIORITY||Median Difference (Net)|-0.672||||0.502|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.502
73970383|NCT03858634|147481202|SUPERIORITY||LS mean difference|-35.3|STANDARD_ERROR_OF_MEAN|12.31||0.0102|TWO_SIDED|80.0|-51.68|-18.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANOVA|||Change at Week 5||-18.92|-51.68|0.0102
73970384|NCT03858634|147481202|SUPERIORITY||LS mean difference|-33.5|STANDARD_ERROR_OF_MEAN|38.77||0.4515|TWO_SIDED|80.0|-96.97|30.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||30.02|-96.97|0.4515
73970385|NCT03858634|147481202|SUPERIORITY||LS mean difference|-4.5|STANDARD_ERROR_OF_MEAN|14.56||0.7623|TWO_SIDED|80.0|-23.76|14.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||14.83|-23.76|0.7623
73970386|NCT03858634|147481202|SUPERIORITY||LS mean difference|-88.5|STANDARD_ERROR_OF_MEAN|34.57||0.1247|TWO_SIDED|80.0|-153.65|-23.29||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-23.29|-153.65|0.1247
73970387|NCT03858634|147481202|SUPERIORITY||LS mean difference|-37.7|STANDARD_ERROR_OF_MEAN|11.91||0.0053|TWO_SIDED|80.0|-53.59|-21.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-21.90|-53.59|0.0053
73862774|NCT01264770|147271518|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.005|TWO_SIDED|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.40|-1.04|0.005
73929218|NCT04027218|147388358|SUPERIORITY||Median Difference (Net)|-0.327||||0.744|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.744
73929219|NCT04027218|147388358|SUPERIORITY||Median Difference (Net)|-1.885||||0.059|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.059
73929220|NCT02530294|147388360|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
73929221|NCT02530294|147388361|OTHER||||||<|0.001|||||||ANCOVA|Ranked ANCOVA||||||<0.001
73929222|NCT02530294|147388362|OTHER||||||<|0.001|||||||ANCOVA|Ranked ANCOVA||||||< 0.001
73929223|NCT02530294|147388363|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
73970388|NCT03858634|147481202|SUPERIORITY||LS mean difference|-17.2|STANDARD_ERROR_OF_MEAN|43.23||0.7177|TWO_SIDED|80.0|-87.97|53.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||53.62|-87.97|0.7177
73929224|NCT02530294|147388364|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
73929225|NCT02506816|147388365|OTHER|The P-valor Wilcoxon method is a non-parametric statistical hypothesis test used to evaluate changes from baseline H-score values of the three biomarkers.||||||0.033||||||In order to adjust the multiple comparisons made, Benjamini-Hochberg's false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of 3 biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.||||0.033
73929226|NCT02506816|147388366|OTHER|The differences in the change from baseline of different biomarkers were evaluated by the P-valor Wilcoxon method, a non-parametric statistical hypothesis test.||||||0.03||||||In order to adjust the multiple comparisons made, Benjamini-Hochberg's false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of several biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.||||0.03
73929227|NCT03761628|147388371|OTHER|The clinical performance endpoint - Clinical cure rate on Day 7 - was calculated and presented together with a one-sided 95% CI based on the exact binomial distribution (Clopper-Pearson).|Clinical cure rate|40.9|||||ONE_SIDED|95.0|23.3|||||||"It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% CI for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%."|||23.3|
73929228|NCT03761628|147388372|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Proportion with reduction|72.7|||||TWO_SIDED|95.0|49.8|89.3||||||||89.3|49.8|
73929229|NCT03761628|147388374|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 14|12.5|||||TWO_SIDED|95.0|0.3|52.7||||||||52.7|0.3|
73929230|NCT03761628|147388374|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 35|0.0|||||TWO_SIDED|95.0|0.0|45.9||||||||45.9|0|
73929231|NCT05358821|147388382|SUPERIORITY||Mean Difference|3.3657|STANDARD_ERROR_OF_MEAN|0.2539|<|0.0001|TWO_SIDED|95.0|2.8566|3.8749|||T-test||Difference was calculated as HP - HD.|||3.8749|2.8566|<0.0001
73929232|NCT04649151|147388388|NON_INFERIORITY|The noninferiority of Geometric Mean value (based on geometric least squares means \[GLSM\]) was considered demonstrated if: The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).|GMR|1.078|||||TWO_SIDED|95.0|0.94|1.237|||||GMR of P203 vs P301|||1.237|0.940|
73929233|NCT04649151|147388389|NON_INFERIORITY|Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \>-10%. and a point estimator \>-5% (minimum threshold)|percentage difference|-0.2|||||TWO_SIDED|95.0|-2.1|1.9|||||SRR difference of P203 vs P301|||1.9|-2.1|
73929234|NCT04649151|147388390|NON_INFERIORITY|The lower bound of the 95% CI of noninferiority margin of 1.5. GMR point estimate \>=0.8 (minimum threshold).|GMR|5.071|||||TWO_SIDED|95.0|4.477|5.745|||||GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301|||5.745|4.477|
73929235|NCT04649151|147388391|NON_INFERIORITY|Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \>-10%.|SRR Difference|0.7|||||TWO_SIDED|95.0|-0.8|2.4|||||SRR difference of P203 BD-Day 29 vs P301 Day 57|||2.4|-0.8|
73929236|NCT04649151|147388392|SUPERIORITY|The superiority of GMC (based on GLSM\] was considered demonstrated if: The lower bound of the 95% CI of the GMR was \>1|GMR|48.191|||||TWO_SIDED|95.0|43.765|53.065|||||GMR of P203 vs P301|||53.065|43.765|
73929237|NCT04649151|147388395|NON_INFERIORITY|The noninferiority of Geometric Mean value (based on GLSM) was considered demonstrated if: The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).|GMR|4.493|||||TWO_SIDED|95.0|3.972|5.083|||||GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301|||5.083|3.972|
73970389|NCT03858634|147481202|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|14.35||0.6682|TWO_SIDED|80.0|-25.26|12.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||12.78|-25.26|0.6682
73970390|NCT03858634|147481202|SUPERIORITY||LS mean difference|-95.2|STANDARD_ERROR_OF_MEAN|29.16||0.0823|TWO_SIDED|80.0|-150.21|-40.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-40.24|-150.21|0.0823
73970391|NCT03858634|147481202|SUPERIORITY||LS mean difference|-38.1|STANDARD_ERROR_OF_MEAN|12.95||0.0087|TWO_SIDED|80.0|-55.38|-20.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-20.92|-55.38|0.0087
73970392|NCT03858634|147481202|SUPERIORITY||LS mean difference|-31.7|STANDARD_ERROR_OF_MEAN|38.73||0.4734|TWO_SIDED|80.0|-95.11|31.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||31.76|-95.11|0.4734
73970393|NCT03858634|147481202|SUPERIORITY||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|14.91||0.813|TWO_SIDED|80.0|-23.33|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||16.18|-23.33|0.8130
73970394|NCT03858634|147481202|SUPERIORITY||LS mean difference|-92.0|STANDARD_ERROR_OF_MEAN|31.1||0.0979|TWO_SIDED|80.0|-150.6|-33.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-33.32|-150.60|0.0979
73970395|NCT03858634|147481202|SUPERIORITY||LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|13.48||0.0122|TWO_SIDED|80.0|-55.48|-19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-19.61|-55.48|0.0122
73970396|NCT03858634|147481202|SUPERIORITY||LS mean difference|-32.1|STANDARD_ERROR_OF_MEAN|35.35||0.431|TWO_SIDED|80.0|-89.98|25.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||25.81|-89.98|0.4310
74088071|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.59|3.14|||Regression, Logistic|||Week 2: Odds ratio and 95 percent (%) confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.59|<.0001
74088072|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0085|TWO_SIDED|95.0|1.12|2.18|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|1.12|0.0085
73929238|NCT04649151|147388398|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|60.3|||||TWO_SIDED|95.0|26.6|78.6|||VE|Vaccine efficacy (VE, percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||78.6|26.6|
73929239|NCT04649151|147388399|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|43.5|||||TWO_SIDED|95.0|-16.5|72.2|||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||72.2|-16.5|
73929240|NCT04649151|147388400|OTHER||VE|100.0|||||TWO_SIDED|95.0|61.2||NA = not estimable (not reached).||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.||||61.2|
73929241|NCT04649151|147388401|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|89.9|||||TWO_SIDED|95.0|51.0|98.9|||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||98.9|51.0|
73929242|NCT03907683|147388416|SUPERIORITY||Mean Difference (Final Values)|0.16412|STANDARD_ERROR_OF_MEAN|0.08||0.037|TWO_SIDED|95.0|0.0098|0.3185|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday move more messages would not differ from zero||0.3185|.0098|0.037
73929243|NCT03907683|147388416|SUPERIORITY||Mean Difference (Net)|0.12538|STANDARD_ERROR_OF_MEAN|0.07674||0.106|TWO_SIDED|95.0|-0.0274|0.2781|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday sit less messages would not differ from zero||0.2781|-0.0274|.106
73929244|NCT03907683|147388416|SUPERIORITY||Mean Difference (Net)|0.24738|STANDARD_ERROR_OF_MEAN|0.13746||0.076|TWO_SIDED|95.0|-0.0262|0.521|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday inspirational quote messages would not differ from zero||.5210|-.0262|.076
73929245|NCT03907683|147388416|SUPERIORITY||Mean Difference (Net)|0.30563|STANDARD_ERROR_OF_MEAN|0.16136||0.062|TWO_SIDED|95.0|-0.0156|0.6268|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend move more messages would not differ from zero||.6268|-.0156|.062
73929246|NCT03907683|147388416|SUPERIORITY||Mean Difference (Net)|0.277|STANDARD_ERROR_OF_MEAN|0.10676||0.11|TWO_SIDED|95.0|0.0645|0.4895|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend sit less messages would not differ from zero||.4895|.0645|0.11
73929247|NCT03907683|147388416|SUPERIORITY||Mean Difference (Net)|0.10837|STANDARD_ERROR_OF_MEAN|0.16895||0.523|TWO_SIDED|95.0|-0.2279|0.4447|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend inspirational quote messages would not differ from zero||0.4447|-0.2279|.523
73929248|NCT03400332|147388440|OTHER||Hazard Ratio, log|0.94||||0.7416|TWO_SIDED|95.0|0.61|1.45|||Log Rank|||||1.45|0.61|0.7416
73929249|NCT03901963|147388446|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.0001|TWO_SIDED|95.0|2.37|8.57||Tested at 2-sided 0.05 significance level through stratified CMH method. Stratification factor included baseline cytogenetic risk per investigator'|stratified Cochran-Mantel-Haenszel (CMH)||Odds ratio and 95% CI were estimated by Mantel-Haenszel method. Stratification factor included baseline cytogenetic risk per investigator's assessment (high risk versus standard/unknown risk) as used for randomization of the study.|||8.57|2.37|<0.0001
73929250|NCT05619692|147388543|SUPERIORITY||Difference in LS Means|1.5|STANDARD_ERROR_OF_MEAN|1.11||0.1642|TWO_SIDED|95.0|-0.64|3.73||The p-value was obtained using MMRM model which included treatment, visit, treatment-by-visit interaction as categorical covariates, and WAIS-IV at baseline as continuous covariates.|MRMM||Difference was calculated as SAGE-718 - placebo.|||3.73|-0.64|0.1642
73929251|NCT00167934|147388632|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||< 0.0001
73929252|NCT00167934|147388633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||ANCOVA|||||||0.04
73929253|NCT04951622|147388645|SUPERIORITY||Difference of LS Means|-1.45|STANDARD_ERROR_OF_MEAN|0.47|=|0.002|TWO_SIDED|95.0|-2.38|-0.52|||mixed effects model for repeated measure|||||-0.52|-2.38|=0.002
73929254|NCT02800148|147388690|EQUIVALENCE|provides 85% power of success|equivalence ratio|107.0|||||TWO_SIDED|90.0|96.1|115.5||No p-value as calculated for bioequivalence, just a T/R ratio and 90% confidence interval|Fieller's method|||||115.5|96.1|
73929255|NCT01455012|147388691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-160.34|STANDARD_ERROR_OF_MEAN|26.46|<|0.0001|TWO_SIDED|95.0|-213.23|-107.45||The analysis of this primary efficacy variable was performed using a two-sided alpha level of 5 %.|ANCOVA||The treatment effect was estimated on the basis of the Least Square Mean (LSM) of the difference as well as on the 95 % Confidence Interval and the p-value for that difference. Difference to Placebo was calculated as Rotigotine-Placebo.|The 95 % Confidence Interval (CI) and the p-value for the mean difference between Rotigotine and Placebo was obtained from a linear Analysis of Covariance (ANCOVA) model with fixed effects for treatment and Baseline antihypertensive use and a covariate for the Baseline number of nocturnal elevations of Systolic Blood Pressure that are associated with Periodic Limb Movements (PLMs).||-107.45|-213.23|<0.0001
73929256|NCT01434290|147388713|SUPERIORITY|||||||0.19|||||||One sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.19
73929257|NCT01434290|147388713|SUPERIORITY|||||||0.08|||||||One sample z-test|one-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.08
73929258|NCT01434290|147388714|SUPERIORITY|||||||0.18|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.18
73929259|NCT01434290|147388714|SUPERIORITY|||||||0.38|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.38
73970397|NCT03858634|147481202|SUPERIORITY||LS mean difference|-7.1|STANDARD_ERROR_OF_MEAN|15.22||0.6452|TWO_SIDED|80.0|-27.38|13.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||13.12|-27.38|0.6452
73970398|NCT03858634|147481202|SUPERIORITY||LS mean difference|-89.2|STANDARD_ERROR_OF_MEAN|37.02||0.1375|TWO_SIDED|80.0|-159.04|-19.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-19.44|-159.04|0.1375
73970399|NCT03858634|147481202|SUPERIORITY||LS mean difference|-39.6|STANDARD_ERROR_OF_MEAN|14.59||0.0143|TWO_SIDED|80.0|-58.97|-20.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-20.15|-58.97|0.0143
73970400|NCT03858634|147481202|SUPERIORITY||LS mean difference|-22.1|STANDARD_ERROR_OF_MEAN|36.4||0.5867|TWO_SIDED|80.0|-81.7|37.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||37.52|-81.70|0.5867
73970401|NCT03858634|147481202|SUPERIORITY||LS mean difference|6.1|STANDARD_ERROR_OF_MEAN|14.38||0.6745|TWO_SIDED|80.0|-12.99|25.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||25.27|-12.99|0.6745
74029535|NCT01703819|147613574|SUPERIORITY_OR_OTHER|||||||0.5702||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOV As.||||0.5702
73929260|NCT01434290|147388719|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[Bowel one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.03
73929261|NCT01434290|147388719|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[Bowel one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.03
73929262|NCT01434290|147388719|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017||\[Urinary one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.09
73929263|NCT01434290|147388719|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Two-side significance level of 0.017||\[Urinary one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.43
73929264|NCT01434290|147388720|SUPERIORITY|||||||0.39|||||||One-sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.39
74029536|NCT02145156|147613660|SUPERIORITY_OR_OTHER|||||||0.36|||||||Fisher Exact|||||||.36
74029537|NCT02145156|147613660|SUPERIORITY_OR_OTHER|||||||0.18|||||||Fisher Exact|||||||.18
74029538|NCT02145156|147613660|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher Exact|||||||.22
73929265|NCT01434290|147388720|SUPERIORITY|||||||0.21|||||||One sample z-test|One-side significance level of 0.025||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.21
73929266|NCT01434290|147388721|SUPERIORITY|||||||0.44|||||||one sampe z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.44
74029539|NCT02145156|147613660|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||||||.88
74029540|NCT02145156|147613661|SUPERIORITY_OR_OTHER|||||||0.35|||||||Fisher Exact|||||||0.35
74029541|NCT02145156|147613661|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
73929267|NCT01434290|147388721|SUPERIORITY|||||||0.53|||||||One sample z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.53
73929268|NCT01434290|147388722|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year Index Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.16
73929269|NCT01434290|147388722|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year Index Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.03
73929270|NCT01434290|147388722|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year VAS Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.83
73929271|NCT01434290|147388722|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year VAS Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.86
73929272|NCT00558103|147388731|SUPERIORITY_OR_OTHER||Percentage of participants|29.0|||||TWO_SIDED|90.0|17.2|43.3|||||The estimated value represents the percentage of participants with CR and PR.|||43.3|17.2|
73929273|NCT00558103|147388731|SUPERIORITY_OR_OTHER||Percentage of participants|45.0|||||TWO_SIDED|90.0|30.9|59.3|||||The estimated value represents the percentage of participants with CR and PR.|||59.3|30.9|
73929274|NCT00558103|147388731|SUPERIORITY_OR_OTHER||Percentage of participants|47.0|||<|0.001|TWO_SIDED|90.0|32.8|62.1||Comparision of participants receiving lapatanib 1500 mg + placebo to historical control of 10% response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1500 mg + placebo with CR and PR.|||62.1|32.8|<0.001
73929275|NCT00558103|147388731|SUPERIORITY_OR_OTHER||Percentage of participants|31.0|||||TWO_SIDED|90.0|11.3|57.3|||||The estimated value represents the percentage of participants with CR and PR.|||57.3|11.3|
73929276|NCT00558103|147388731|SUPERIORITY_OR_OTHER||Percentage of participants|58.0|||<|0.001|TWO_SIDED|90.0|43.3|71.5||Comparision of participants receiving lapatanib 1000 mg + pazopanib 400 mg to 10% historical response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1000 mg + pazopanib 400 mg with CR and PR.|||71.5|43.3|<0.001
73929277|NCT00558103|147388731|SUPERIORITY_OR_OTHER||Difference in percentage of participants|11.0||||0.485|TWO_SIDED|90.0|-8.3|29.7|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.|||29.7|-8.3|0.485
73929278|NCT00558103|147388731|SUPERIORITY_OR_OTHER||Difference in percentage of participants|27.0||||0.116|TWO_SIDED|90.0|2.3|52.0|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.|||52.0|2.3|0.116
73929279|NCT03993938|147388740|OTHER|Delta PVI percentage change and Delta LAP (v-wave) percentage change were correlated using Spearman's rank correlation - two-tailed.|Spearman's rank correlation|0.34||||0.066|TWO_SIDED||||||Spearman's rank correlation|||||||0.066
73929280|NCT03548584|147388741|SUPERIORITY||LS Mean Difference|-5.32||||0.0026|TWO_SIDED|95.0|-8.77|-1.87||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||||-1.87|-8.77|0.0026
73929281|NCT03548584|147388742|SUPERIORITY||LS Mean Difference|-0.27||||0.0078|TWO_SIDED|95.0|-0.47|-0.07||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||||-0.07|-0.47|0.0078
73929282|NCT03548584|147388743|SUPERIORITY||LS Mean Difference|-1.95||||0.004|TWO_SIDED|95.0|-3.28|-0.63||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Aggressive Behavior||-0.63|-3.28|0.0040
73929283|NCT03548584|147388743|SUPERIORITY||LS Mean Difference|-1.41||||0.0296|TWO_SIDED|95.0|-2.68|-0.14||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Physically Nonaggressive Behavior||-0.14|-2.68|0.0296
73929284|NCT03548584|147388743|SUPERIORITY||LS Mean Difference|-1.24||||0.0113|TWO_SIDED|95.0|-2.21|-0.28||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Verbally Agitated Behavior||-0.28|-2.21|0.0113
74029542|NCT02145156|147613661|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
74029543|NCT02145156|147613661|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
74029544|NCT02145156|147613662|SUPERIORITY_OR_OTHER|||||||0.37|||||||Fisher Exact|||||||0.37
74029545|NCT02145156|147613662|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
74029546|NCT02145156|147613662|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||.25
74029547|NCT02145156|147613662|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||||||.70
74029548|NCT02145156|147613663|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
74029549|NCT02145156|147613663|SUPERIORITY_OR_OTHER|||||||0.52|||||||Fisher Exact|||||||.52
74029550|NCT02145156|147613663|SUPERIORITY_OR_OTHER|||||||0.71|||||||Fisher Exact|||||||.71
74029551|NCT02145156|147613663|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||.34
74029552|NCT02145156|147613664|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fisher Exact|||||||0.16
74029553|NCT02145156|147613664|SUPERIORITY_OR_OTHER|||||||0.15|||||||Fisher Exact|||||||.15
74029554|NCT02145156|147613664|SUPERIORITY_OR_OTHER|||||||0.98|||||||Fisher Exact|||||||.98
73929285|NCT03548584|147388743|SUPERIORITY||LS Mean Difference|-0.36||||0.1941|TWO_SIDED|95.0|-0.9|0.18||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Hiding and Hoarding||0.18|-0.90|0.1941
73929286|NCT03548584|147388744|SUPERIORITY||LS Mean Difference|0.85||||0.4242|TWO_SIDED|95.0|-1.24|2.93||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change From Baseline at Week 2||2.93|-1.24|0.4242
73970402|NCT03858634|147481202|SUPERIORITY||LS mean difference|-85.6|STANDARD_ERROR_OF_MEAN|29.99||0.1039|TWO_SIDED|80.0|-142.18|-29.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-29.09|-142.18|0.1039
73970403|NCT03858634|147481202|SUPERIORITY||LS mean difference|-42.5|STANDARD_ERROR_OF_MEAN|15.12||0.0116|TWO_SIDED|80.0|-62.6|-22.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-22.36|-62.60|0.0116
73970404|NCT03858634|147481202|SUPERIORITY||LS mean difference|-23.1|STANDARD_ERROR_OF_MEAN|37.49||0.5807|TWO_SIDED|80.0|-84.55|38.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||38.26|-84.55|0.5807
73929287|NCT03548584|147388744|SUPERIORITY||LS Mean Difference|-1.14||||0.3665|TWO_SIDED|95.0|-3.63|1.34||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change From Baseline at Week 4||1.34|-3.63|0.3665
73929288|NCT03548584|147388744|SUPERIORITY||LS Mean Difference|-2.32||||0.1065|TWO_SIDED|95.0|-5.15|0.5||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 6||0.50|-5.15|0.1065
73929289|NCT03548584|147388744|SUPERIORITY||LS Mean Difference|-5.08||||0.0011|TWO_SIDED|95.0|-8.12|-2.05||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 8||-2.05|-8.12|0.0011
73970405|NCT03858634|147481202|SUPERIORITY||LS mean difference|8.6|STANDARD_ERROR_OF_MEAN|15.16||0.5765|TWO_SIDED|80.0|-11.55|28.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||28.80|-11.55|0.5765
73970406|NCT03858634|147481202|SUPERIORITY||LS mean difference|-86.2|STANDARD_ERROR_OF_MEAN|28.36||0.0933|TWO_SIDED|80.0|-139.7|-32.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-32.75|-139.70|0.0933
73970407|NCT03858634|147481202|SUPERIORITY||LS mean difference|-39.3||||0.0173|TWO_SIDED|80.0|-59.29|-19.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-19.37|-59.29|0.0173
74029555|NCT02145156|147613664|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||.34
74029556|NCT02145156|147613665|SUPERIORITY_OR_OTHER|||||||0.37|||||||Fisher Exact|||||||0.37
74029557|NCT02145156|147613665|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
74029558|NCT02145156|147613665|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||.25
74088073|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|2.71|||<|0.0001|TWO_SIDED|95.0|1.89|3.88|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.88|1.89|<.0001
74088074|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.62|3.28|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.28|1.62|<.0001
73929290|NCT03548584|147388744|SUPERIORITY||LS Mean Difference|-6.47|||<|0.0001|TWO_SIDED|95.0|-9.54|-3.4||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 10||-3.40|-9.54|<.0001
73929291|NCT03548584|147388744|SUPERIORITY||LS Mean Difference|-5.32||||0.0026|TWO_SIDED|95.0|-8.77|-1.87||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 12||-1.87|-8.77|0.0026
73929292|NCT03548584|147388745|SUPERIORITY||LS Mean Difference|0.05||||0.3048|TWO_SIDED|95.0|-0.05|0.16||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 2||0.16|-0.05|0.3048
73929293|NCT03548584|147388745|SUPERIORITY||LS Mean Difference|-0.03||||0.7058|TWO_SIDED|95.0|-0.17|0.12||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 4||0.12|-0.17|0.7058
73929294|NCT03548584|147388745|SUPERIORITY||LS Mean Difference|-0.06||||0.4516|TWO_SIDED|95.0|-0.23|0.1||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 6||0.10|-0.23|0.4516
73970408|NCT03858634|147481202|SUPERIORITY||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|38.36||0.5293|TWO_SIDED|80.0|-90.04|35.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||35.62|-90.04|0.5293
74029559|NCT02145156|147613665|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||||||.70
74029560|NCT02145156|147613666|SUPERIORITY_OR_OTHER|||||||0.87|||||||Chi-squared|||||||0.87
74029561|NCT02145156|147613666|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
74029562|NCT02145156|147613666|SUPERIORITY_OR_OTHER|||||||0.81|||||||Chi-squared|||||||0.81
74029563|NCT02145156|147613666|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||||||0.76
74029564|NCT02145156|147613667|SUPERIORITY_OR_OTHER|||||||0.7|||||||Chi-squared|||||||0.70
74029565|NCT02145156|147613667|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||||||0.41
74029566|NCT02145156|147613667|SUPERIORITY_OR_OTHER|||||||0.59|||||||Chi-squared|||||||0.59
74029567|NCT02145156|147613667|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared|||||||0.74
74029568|NCT02145156|147613668|SUPERIORITY_OR_OTHER|||||||0.38|||||||Chi-squared|||||||0.38
74088075|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|1.91||||0.0005|TWO_SIDED|95.0|1.33|2.75|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.75|1.33|0.0005
74088076|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0005|TWO_SIDED|95.0|1.32|2.73|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.73|1.32|0.0005
74088077|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0009|TWO_SIDED|95.0|1.31|2.86|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.86|1.31|0.0009
73970409|NCT03858634|147481202|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|15.12||0.9676|TWO_SIDED|80.0|-20.73|19.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||19.49|-20.73|0.9676
74029569|NCT02145156|147613668|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||0.17
74029570|NCT02145156|147613668|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.60
74029571|NCT02145156|147613668|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
74029572|NCT02145156|147613669|SUPERIORITY_OR_OTHER|||||||0.39|||||||Chi-squared|||||||0.39
74088078|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0008|TWO_SIDED|95.0|1.32|2.89|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.89|1.32|0.0008
74088079|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0002|TWO_SIDED|95.0|1.41|3.01|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.01|1.41|0.0002
74029573|NCT02145156|147613669|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
74029574|NCT02145156|147613669|SUPERIORITY_OR_OTHER|||||||0.49|||||||Chi-squared|||||||0.49
74088080|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0022|TWO_SIDED|95.0|1.23|2.57|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.57|1.23|0.0022
73970410|NCT03858634|147481202|SUPERIORITY||LS mean difference|-86.2|STANDARD_ERROR_OF_MEAN|23.38||0.0663|TWO_SIDED|80.0|-130.27|-42.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-42.11|-130.27|0.0663
73970411|NCT03858634|147481202|SUPERIORITY||LS mean difference|-37.4|STANDARD_ERROR_OF_MEAN|15.33||0.0252|TWO_SIDED|80.0|-57.81|-17.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-17.02|-57.81|0.0252
74088081|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0032|TWO_SIDED|95.0|1.21|2.54|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.54|1.21|0.0032
74088082|NCT02709486|147729976|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0013|TWO_SIDED|95.0|1.27|2.69|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.69|1.27|0.0013
74088083|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.3|2.59|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.59|1.30|0.0006
74088084|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.53||||0.016|TWO_SIDED|95.0|1.08|2.16|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|1.08|0.0160
73970412|NCT03858634|147481202|SUPERIORITY||LS mean difference|-19.6|STANDARD_ERROR_OF_MEAN|40.81||0.6637|TWO_SIDED|80.0|-86.45|47.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||47.22|-86.45|0.6637
74029575|NCT02145156|147613669|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|||||||0.14
74029576|NCT02145156|147613670|SUPERIORITY_OR_OTHER|||||||0.09|||||||Chi-squared|||||||0.09
74029577|NCT02145156|147613670|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
74029578|NCT02145156|147613670|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||||||0.15
74029579|NCT02145156|147613670|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
74029580|NCT02145156|147613671|SUPERIORITY_OR_OTHER|||||||0.38|||||||Chi-squared|||||||0.38
74029581|NCT02145156|147613671|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||0.17
74029582|NCT02145156|147613671|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.60
74029583|NCT02145156|147613671|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
74088085|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0008|TWO_SIDED|95.0|1.34|3.07|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.07|1.34|0.0008
74088086|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5118|TWO_SIDED|95.0|0.75|1.8|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.80|0.75|0.5118
73929295|NCT03548584|147388745|SUPERIORITY||LS Mean Difference|-0.27||||0.0052|TWO_SIDED|95.0|-0.46|-0.08||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 8||-0.08|-0.46|0.0052
73929296|NCT03548584|147388745|SUPERIORITY||LS Mean Difference|-0.27||||0.006|TWO_SIDED|95.0|-0.47|-0.08||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 10||-0.08|-0.47|0.0060
73929297|NCT03548584|147388745|SUPERIORITY||LS Mean Difference|-0.27||||0.0078|TWO_SIDED|95.0|-0.47|-0.07||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 12||-0.07|-0.47|0.0078
73929298|NCT03548584|147388746|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1975|TWO_SIDED|95.0|-0.05|0.26|||Cochran-Mantel-Haenszel|||Week 2||0.26|-0.05|0.1975
73970413|NCT03858634|147481202|SUPERIORITY||LS mean difference|-1.6|STANDARD_DEVIATION|15.35||0.9173|TWO_SIDED|80.0|-22.04|18.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||18.81|-22.04|0.9173
73970414|NCT03858634|147481202|SUPERIORITY||LS mean difference|-96.2|STANDARD_ERROR_OF_MEAN|26.55||0.0685|TWO_SIDED|80.0|-146.23|-46.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-46.10|-146.23|0.0685
73970415|NCT03858634|147481202|SUPERIORITY||LS mean difference|-39.7|STANDARD_ERROR_OF_MEAN|15.96||0.023|TWO_SIDED|80.0|-60.91|-18.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-18.44|-60.91|0.0230
73929299|NCT03548584|147388746|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.0084|TWO_SIDED|95.0|-0.44|-0.06|||Cochran-Mantel-Haenszel|||Week 4||-0.06|-0.44|0.0084
73929300|NCT03548584|147388746|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.0101|TWO_SIDED|95.0|-0.46|-0.06|||Cochran-Mantel-Haenszel|||Week 6||-0.06|-0.46|0.0101
73970416|NCT03858634|147481202|SUPERIORITY||LS mean difference|-19.1|STANDARD_ERROR_OF_MEAN|37.62||0.6471|TWO_SIDED|80.0|-80.69|42.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||42.54|-80.69|0.6471
73970417|NCT03858634|147481202|SUPERIORITY||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|15.52||0.8044|TWO_SIDED|80.0|-24.56|16.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||16.75|-24.56|0.8044
73970418|NCT03858634|147481202|SUPERIORITY||LS mean difference|-99.5|STANDARD_ERROR_OF_MEAN|28.71||0.0741|TWO_SIDED|80.0|-153.63|-45.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-45.37|-153.63|0.0741
73970419|NCT03858634|147481202|SUPERIORITY||LS mean difference|-39.9|STANDARD_ERROR_OF_MEAN|15.89||0.0219|TWO_SIDED|80.0|-61.0|-18.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-18.72|-61.00|0.0219
73970420|NCT03858634|147481202|SUPERIORITY||LS mean difference|-25.4|STANDARD_ERROR_OF_MEAN|37.15||0.5436|TWO_SIDED|80.0|-86.21|35.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||35.46|-86.21|0.5436
73970421|NCT03858634|147481202|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|16.13||0.9149|TWO_SIDED|80.0|-23.2|19.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||19.71|-23.20|0.9149
73970422|NCT03858634|147481202|SUPERIORITY||LS mean difference|-94.8|STANDARD_ERROR_OF_MEAN|25.34||0.0646|TWO_SIDED|80.0|-142.63|-47.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-47.05|-142.63|0.0646
73970423|NCT03858634|147481202|SUPERIORITY||LS mean difference|-34.2|STANDARD_ERROR_OF_MEAN|17.09||0.0611|TWO_SIDED|80.0|-56.89|-11.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-11.41|-56.89|0.0611
73970424|NCT03858634|147481202|SUPERIORITY||LS mean difference|-22.0|STANDARD_ERROR_OF_MEAN|38.28||0.606|TWO_SIDED|80.0|-84.68|40.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||40.71|-84.68|0.6060
73970425|NCT03858634|147481202|SUPERIORITY||LS mean difference|-6.9|STANDARD_ERROR_OF_MEAN|16.61||0.6823|TWO_SIDED|80.0|-29.0|15.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||15.18|-29.00|0.6823
73970426|NCT03858634|147481202|SUPERIORITY||LS mean difference|-99.7|STANDARD_ERROR_OF_MEAN|24.56||0.0556|TWO_SIDED|80.0|-146.02|-53.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-53.41|-146.02|0.0556
73970427|NCT03858634|147481202|SUPERIORITY||LS mean difference|-33.4|STANDARD_ERROR_OF_MEAN|16.99||0.0652|TWO_SIDED|80.0|-55.98|-10.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-10.76|-55.98|0.0652
73929301|NCT03548584|147388746|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0008|TWO_SIDED|95.0|-0.59|-0.15|||Cochran-Mantel-Haenszel|||Week 8||-0.15|-0.59|0.0008
73929302|NCT03548584|147388746|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0023|TWO_SIDED|95.0|-0.55|-0.12|||Cochran-Mantel-Haenszel|||Week 10||-0.12|-0.55|0.0023
73929303|NCT03548584|147388746|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.007|TWO_SIDED|95.0|-0.57|-0.09|||Cochran-Mantel-Haenszel|||Week 12||-0.09|-0.57|0.0070
73929304|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.1||||0.729|TWO_SIDED|95.0|0.64|1.91|||Cochran-Mantel-Haenszel|||\>/= 20%: Week 2||1.91|0.64|0.7290
73929305|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.09||||0.6196|TWO_SIDED|95.0|0.78|1.52|||Cochran-Mantel-Haenszel|||\>/=20%: Week 4||1.52|0.78|0.6196
73929306|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.16||||0.2718|TWO_SIDED|95.0|0.88|1.53|||Cochran-Mantel-Haenszel|||\>/=20%: Week 6||1.53|0.88|0.2718
73929307|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.52||||0.0004|TWO_SIDED|95.0|1.19|1.93|||Cochran-Mantel-Haenszel|||\>/=20%: Week 8||1.93|1.19|0.0004
73929308|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.42||||0.0006|TWO_SIDED|95.0|1.15|1.76|||Cochran-Mantel-Haenszel|||\>/=20%: Week 10||1.76|1.15|0.0006
73929309|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.41||||0.0004|TWO_SIDED|95.0|1.15|1.72|||Cochran-Mantel-Haenszel|||\>/=20%: Week 12||1.72|1.15|0.0004
73929310|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.22||||0.7211|TWO_SIDED|95.0|0.39|3.85|||Cochran-Mantel-Haenszel|||\>/=30%: Week 2||3.85|0.39|0.7211
73929311|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.11||||0.7606|TWO_SIDED|95.0|0.57|2.14|||Cochran-Mantel-Haenszel|||\>/=30%: Week 4||2.14|0.57|0.7606
73929312|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.12||||0.5902|TWO_SIDED|95.0|0.74|1.68|||Cochran-Mantel-Haenszel|||\>/=30%: Week 6||1.68|0.74|0.5902
73970428|NCT03858634|147481202|SUPERIORITY||LS mean difference|-26.3|STANDARD_ERROR_OF_MEAN|41.45||0.5714|TWO_SIDED|80.0|-94.14|41.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||41.62|-94.14|0.5714
73970429|NCT03858634|147481202|OTHER||LS mean difference|-10.5|STANDARD_ERROR_OF_MEAN|16.82||0.5386|TWO_SIDED|80.0|-32.93|11.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||11.83|-32.93|0.5386
73970430|NCT03858634|147481202|SUPERIORITY||LS mean difference|-99.0|STANDARD_ERROR_OF_MEAN|21.41||0.0438|TWO_SIDED|80.0|-139.35|-58.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-58.60|-139.35|0.0438
73970431|NCT03858634|147481202|OTHER||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|19.66||0.1829|TWO_SIDED|80.0|-53.38|-1.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-1.08|-53.38|0.1829
74029584|NCT03408873|147613692|OTHER||Mean Difference (Final Values)|-31.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
74029585|NCT03408873|147613692|OTHER||Mean Difference (Final Values)|-11.7||||0.12|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.12
74029586|NCT03408873|147613693|OTHER||Mean Difference (Final Values)|-19.6||||0.0599|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.0599
74029587|NCT03408873|147613693|OTHER||Mean Difference (Final Values)|-3.2||||0.63|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.63
73929313|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.7||||0.0054|TWO_SIDED|95.0|1.14|2.54|||Cochran-Mantel-Haenszel|||\>/=30%: Week 8||2.54|1.14|0.0054
73929314|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.59||||0.0066|TWO_SIDED|95.0|1.11|2.26|||Cochran-Mantel-Haenszel|||\>/=30%: Week 10||2.26|1.11|0.0066
73929315|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.62||||0.0017|TWO_SIDED|95.0|1.18|2.23|||Cochran-Mantel-Haenszel|||\>/=30%: Week 12||2.23|1.18|0.0017
73929316|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.11||||0.9074|TWO_SIDED|95.0|0.2|5.97|||Cochran-Mantel-Haenszel|||\>/=40%: Week 2||5.97|0.20|0.9074
73929317|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|0.98||||0.9625|TWO_SIDED|95.0|0.36|2.64|||Cochran-Mantel-Haenszel|||\>/=40%: Week 4||2.64|0.36|0.9625
73929318|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.26||||0.512|TWO_SIDED|95.0|0.63|2.53|||Cochran-Mantel-Haenszel|||\>/=40%: Week 6||2.53|0.63|0.5120
73929319|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.98||||0.0244|TWO_SIDED|95.0|1.03|3.79|||Cochran-Mantel-Haenszel|||\>/=40%: Week 8||3.79|1.03|0.0244
73929320|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.86||||0.0161|TWO_SIDED|95.0|1.08|3.18|||Cochran-Mantel-Haenszel|||\>/=40%: Week 10||3.18|1.08|0.0161
73929321|NCT03548584|147388747|SUPERIORITY||Ratio of Response Rate|1.62||||0.0347|TWO_SIDED|95.0|1.0|2.61|||Cochran-Mantel-Haenszel|||\>/=40%: Week 12||2.61|1.00|0.0347
73929322|NCT03548584|147388748|SUPERIORITY||Ratio of Response Rate|0.64||||0.1503|TWO_SIDED|95.0|0.35|1.16|||Cochran-Mantel-Haenszel|||Week 2||1.16|0.35|0.1503
73929323|NCT03548584|147388748|SUPERIORITY||Ratio of Response Rate|1.07||||0.7559|TWO_SIDED|95.0|0.69|1.67|||Cochran-Mantel-Haenszel|||Week 4||1.67|0.69|0.7559
73929324|NCT03548584|147388748|SUPERIORITY||Ratio of Response Rate|1.23||||0.2246|TWO_SIDED|95.0|0.88|1.72|||Cochran-Mantel-Haenszel|||Week 6||1.72|0.88|0.2246
73929325|NCT03548584|147388748|SUPERIORITY||Ratio of Response Rate|1.38||||0.0276|TWO_SIDED|95.0|1.02|1.87|||Cochran-Mantel-Haenszel|||Week 8||1.87|1.02|0.0276
73929326|NCT03548584|147388748|SUPERIORITY||Ratio of Response Rate|1.46||||0.0031|TWO_SIDED|95.0|1.12|1.89|||Cochran-Mantel-Haenszel|||Week 10||1.89|1.12|0.0031
73929327|NCT03548584|147388748|SUPERIORITY||Ratio of Response Rate|1.47||||0.0017|TWO_SIDED|95.0|1.14|1.89|||Cochran-Mantel-Haenszel|||Week 12||1.89|1.14|0.0017
73929328|NCT03548584|147388749|SUPERIORITY||Ratio of Response Rate|1.1||||0.8549|TWO_SIDED|95.0|0.4|3.03|||Cochran-Mantel-Haenszel|||Week 2||3.03|0.40|0.8549
73929329|NCT03548584|147388749|SUPERIORITY||Ratio of Response Rate|1.95||||0.0093|TWO_SIDED|95.0|1.14|3.32|||Cochran-Mantel-Haenszel|||Week 4||3.32|1.14|0.0093
73929330|NCT03548584|147388749|SUPERIORITY||Ratio of Response Rate|1.56||||0.0083|TWO_SIDED|95.0|1.1|2.22|||Cochran-Mantel-Haenszel|||Week 6||2.22|1.10|0.0083
73929331|NCT03548584|147388749|SUPERIORITY||Ratio of Response Rate|1.85|||<|0.0001|TWO_SIDED|95.0|1.32|2.58|||Cochran-Mantel-Haenszel|||Week 8||2.58|1.32|<.0001
73929332|NCT03548584|147388749|SUPERIORITY||Ratio of Response Rate|1.57||||0.0005|TWO_SIDED|95.0|1.18|2.09|||Cochran-Mantel-Haenszel|||Week 10||2.09|1.18|0.0005
73929333|NCT03548584|147388749|SUPERIORITY||Ratio of Response Rate|1.32||||0.016|TWO_SIDED|95.0|1.03|1.69|||Cochran-Mantel-Haenszel|||Week 12||1.69|1.03|0.0160
73929334|NCT02215070|147388758|OTHER|||||||0.12|||||||Chi-squared|||||||0.12
74029588|NCT03408873|147613695|OTHER||Mean Difference (Final Values)|-10.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
73929335|NCT02215070|147388760|OTHER|||||||0.006|||||||Log Rank|||||||0.006
73970432|NCT03858634|147481202|SUPERIORITY||LS mean difference|-25.6|STANDARD_ERROR_OF_MEAN|37.59||0.5443|TWO_SIDED|80.0|-87.2|35.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||35.94|-87.20|0.5443
73929336|NCT02215070|147388761|OTHER|||||||0.002|||||||Log Rank|||||||0.002
73929337|NCT01167712|147388764|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.74|1.06||||||Estimated hazard of first progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel.||1.06|.74|
73970433|NCT03858634|147481202|SUPERIORITY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|18.43||0.6748|TWO_SIDED|80.0|-32.39|16.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||16.66|-32.39|0.6748
73929338|NCT01167712|147388765|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.72|1.23||||||||1.23|.72|
73929339|NCT03633396|147388768|OTHER||Least Squares (LS) Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.98||0.944|TWO_SIDED|95.0|-4.05|3.77|||Mixed-model Repeated Measures (MMRM)|MMRM including fixed effects of treatment, history of plaque psoriasis, visit, treatment by visit interaction, and Baseline PPPASI score as covariate.|Least-squares mean difference = Imsidolimab - Placebo|The change from Baseline in PPPASI at Week 16 was analyzed using a a general linear mixed model for repeated measures (MMRM). The model included fixed effects for treatment, history of plaque psoriasis (Yes/No), visit, treatment by visit interaction, and Baseline PPPASI score as covariate.||3.77|-4.05|0.944
73929340|NCT03633396|147388770|OTHER||Odds Ratio (OR)|0.879|||||TWO_SIDED|95.0|0.288|2.686|||||Odds ratio from a logistic regression model including treatment as fixed effect, history of plaque psoriasis and Baseline PPPASI score as covariates and using multiple imputation for missing data.|||2.686|0.288|
73929341|NCT03633396|147388771|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|0.5|13.9|||||Odds ratio from a logistic regression model including treatment as fixed effect, history of plaque psoriasis and Baseline PPPIGA score as covariates and using multiple imputation for missing data.|||13.9|0.5|
73929342|NCT01896895|147388806|SUPERIORITY||LS mean difference|-1.2|||=|0.0004|TWO_SIDED|95.0|-1.9|-0.6|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. First step of hierarchy is hypothesis of superiority of 50 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.||-0.6|-1.9|=0.0004
73929343|NCT01896895|147388806|SUPERIORITY||LS mean difference|-0.5|||=|0.1452|TWO_SIDED|95.0|-1.1|0.2|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. Second step of hierarchy is hypothesis of superiority of 25 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.||0.2|-1.1|=0.1452
73929344|NCT00293384|147388809|SUPERIORITY_OR_OTHER||proportion|0.57||||0.1|TWO_SIDED|||||85% statistical power|Simon optimal design|||Optimal Simon design for phase II study. p0=45% p1=65%.||||0.10
73929345|NCT00293384|147388810|SUPERIORITY_OR_OTHER||proportion|0.63||||||||||||||||||
73929346|NCT00293384|147388812|SUPERIORITY_OR_OTHER||proportion|0.06|||||TWO_SIDED|||||||||||||
73929347|NCT04482179|147388813|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<.05
73929348|NCT04482179|147388814|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<.05
73929349|NCT01633944|147388833|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.67||||0.0012|TWO_SIDED|95.0|-1.07|-0.26|||ANCOVA|||||-0.26|-1.07|0.0012
73929350|NCT01633944|147388834|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction||||0.0012
73929351|NCT01633944|147388834|SUPERIORITY_OR_OTHER|||||||0.0754|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥50% pain reduction||||0.0754
73929352|NCT02583256|147388841|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.||1.3|1.1|
73970434|NCT03858634|147481202|SUPERIORITY||LS mean difference|-96.2|STANDARD_ERROR_OF_MEAN|16.97||0.0297|TWO_SIDED|80.0|-128.19|-64.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-64.19|-128.19|0.0297
73929353|NCT02583256|147388841|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.93|||||TWO_SIDED|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.||1.0|0.9|
73929354|NCT02583256|147388841|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.||1.3|1.1|
73929355|NCT02583256|147388841|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.18|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.||1.3|1.1|
73929356|NCT02583256|147388842|SUPERIORITY|Superiority criterion for the GMT ratio: Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.||1.3|1.1|
73929357|NCT02583256|147388842|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|0.93|||||TWO_SIDED|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.||1.0|0.9|
73929358|NCT02583256|147388842|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.||1.3|1.1|
73929359|NCT02583256|147388842|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.||1.3|1.1|
74088087|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0093|TWO_SIDED|95.0|1.25|4.81|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.81|1.25|0.0093
73929360|NCT02583256|147388843|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.39|||||TWO_SIDED|95.0|1.28|1.51||||||Comparison performed for strain A/H1N1.||1.51|1.28|
73929361|NCT02583256|147388843|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.06|||||TWO_SIDED|95.0|0.99|1.14||||||Comparison performed for strain A/H3N2||1.14|0.99|
73929362|NCT02583256|147388843|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.42|||||TWO_SIDED|95.0|1.27|1.58||||||Comparison performed for strain B/Yamagata.||1.58|1.27|
73929363|NCT02583256|147388843|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.22|1.51||||||Comparison performed for strain B/Victoria.||1.51|1.22|
73929364|NCT02583256|147388844|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.07|1.32||||||Comparison performed for strain A/H1N1.||1.32|1.07|
73929365|NCT02583256|147388844|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.99|||||TWO_SIDED|95.0|0.9|1.09||||||Comparison performed for strain A/H3N2.||1.09|0.90|
73929366|NCT02583256|147388844|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.12|||||TWO_SIDED|95.0|1.01|1.25||||||Comparison performed for strain B/Yamagata.||1.25|1.01|
73929367|NCT02583256|147388844|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.98|1.27||||||Comparison performed for strain B/Victoria.||1.27|0.98|
73929368|NCT02583256|147388844|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.4|||||TWO_SIDED|95.0|1.3|1.5||||||Comparison performed for strain A/H1N1.||1.5|1.3|
73929369|NCT02583256|147388844|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.1||||||Comparison performed for strain A/H3N2.||1.1|0.9|
73929370|NCT02583256|147388844|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.3|||||TWO_SIDED|95.0|1.2|1.4||||||Comparison performed for strain B/Yamagata.||1.4|1.2|
73929371|NCT02583256|147388844|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.32|||||TWO_SIDED|95.0|1.2|1.5||||||Comparison performed for strain B/Victoria.||1.5|1.2|
73929372|NCT02583256|147388845|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|1.8|||||TWO_SIDED|95.0|-4.9|8.6||||||Comparison performed for strain A/H1N1.||8.6|-4.9|
73929373|NCT02583256|147388845|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|0.9|||||TWO_SIDED|95.0|-5.6|7.3||||||Comparison performed for strain A/H3N2.||7.3|-5.6|
73929374|NCT02583256|147388845|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|4.3|||||TWO_SIDED|95.0|-1.8|10.4||||||Comparison performed for strain B/Yamagata.||10.4|-1.8|
73929375|NCT02583256|147388845|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|2.6|||||TWO_SIDED|95.0|-3.3|8.5||||||Comparison performed for strain B/Victoria.||8.5|-3.3|
73929376|NCT02583256|147388845|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|9.67|||||TWO_SIDED|95.0|3.11|16.17||||||Comparison performed for strain A/H1N1.||16.17|3.11|
73929377|NCT02583256|147388845|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|-3.95|||||TWO_SIDED|95.0|-10.02|2.15||||||Comparison performed for strain A/H3N2.||2.15|-10.02|
73929378|NCT02583256|147388845|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|12.95|||||TWO_SIDED|95.0|6.73|19.12||||||Comparison performed for strain B/Yamagata.||19.12|6.73|
73929379|NCT02583256|147388845|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|8.36|||||TWO_SIDED|95.0|2.17|14.54||||||Comparison performed for strain B/Victoria.||14.54|2.17|
73929380|NCT02103478|147388878|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.144|||||TWO_SIDED|95.0|-3.165|2.876|||||Course 1|||2.876|-3.165|
73929381|NCT02103478|147388878|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.087|||||TWO_SIDED|95.0|-3.463|3.288|||||Course 2|||3.288|-3.463|
73929382|NCT02103478|147388878|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-2.588|||||TWO_SIDED|95.0|-6.074|0.899|||||Course 1|||0.899|-6.074|
73929383|NCT02103478|147388878|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.096|||||TWO_SIDED|95.0|-5.08|4.888|||||Course 2|||4.888|-5.080|
73929384|NCT04988295|147388906|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.56|||Log Rank|||||0.56|0.35|<0.0001
74029589|NCT03408873|147613696|OTHER||Mean Difference (Final Values)|-8.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
74029590|NCT03408873|147613696|OTHER||Mean Difference (Final Values)|-5.8|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||<0.001
74029591|NCT03408873|147613697|OTHER||Mean Difference (Final Values)|-16.6|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
74029592|NCT03408873|147613697|OTHER|We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24) to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.|Mean Difference (Final Values)|-8.1||||0.003|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||0.003
73929385|NCT04988295|147388906|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.0001||95.0|0.36|0.64|||Log Rank|||||0.64|0.36|<0.0001
73929386|NCT05429203|147388931|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||||||0.8
73929387|NCT05429203|147388932|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1
73929388|NCT05429203|147388933|OTHER|||||||0.7||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.7
73929389|NCT05429203|147388934|OTHER|||||||0.4||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.4
73929390|NCT05429203|147388935|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
73929391|NCT05429203|147388936|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
73929392|NCT05429203|147388937|OTHER|||||||0.7||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.7
73929393|NCT05429203|147388938|OTHER|||||||0.6||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.6
73929394|NCT05429203|147388939|OTHER|||||||0.5||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.5
73929395|NCT05429203|147388940|OTHER|||||||0.9||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.9
73929396|NCT05429203|147388941|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
73929397|NCT05429203|147388942|OTHER|||||||0.9||||||the a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.9
73929398|NCT00433654|147388944|SUPERIORITY_OR_OTHER_LEGACY||Percentage|0.0|||<|0.001|ONE_SIDED|95.0||1.7|||exact test of binomial proportions|||Null hypothesis: rate \> 10%||1.7||<0.001
73929399|NCT00433654|147388945|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|0.0||||||95.0||||P-value and confidence interval could not be calculated because both groups were 100% successful.|Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||
73929400|NCT00433654|147388946|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|0.5|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
73929401|NCT00433654|147388947|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|1.9|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
73929402|NCT00433654|147388948|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|2.1|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
73929403|NCT00433654|147388949|SUPERIORITY_OR_OTHER_LEGACY||Percentage|8.3|||<|0.001|ONE_SIDED|95.0||10.7|||exact test of binomial proportions|||Null hypothesis: Percentage of subjects with complication \> 20%||10.7||<0.001
73929404|NCT03748641|147388960|SUPERIORITY||Hazard Ratio (HR)|0.729||||0.0217|TWO_SIDED|95.0|0.556|0.956|||Log Rank|||||0.956|0.556|0.0217
73929405|NCT03748641|147388961|SUPERIORITY||Hazard Ratio (HR)|0.533||||0.0014|TWO_SIDED|95.0|0.361|0.789|||Log Rank|||||0.789|0.361|0.0014
74029593|NCT03408873|147613698|OTHER|We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data.|Mean Difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73862775|NCT01264770|147271518|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.61||||0.02|TWO_SIDED|80.0|-0.94|-0.27|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.27|-0.94|0.020
73929406|NCT03762083|147389000|OTHER|The clinical performance endpoint - Clinical cure rate on Day 7 - was calculated and presented together with a one-sided 95% CI based on the exact binomial distribution (Clopper-Pearson).|Clinical cure rate|81.9|||||ONE_SIDED|95.0|63.1|||||||"It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% confidence interval (CI) for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%."|||63.1|
73929407|NCT03762083|147389001|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 1.|85.7|||||TWO_SIDED|95.0|63.7|97.0||||||||97.0|63.7|
73929408|NCT03762083|147389002|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 2.|90.0|||||TWO_SIDED|95.0|68.3|98.8||||||||98.8|68.3|
73970435|NCT03858634|147481202|SUPERIORITY||LS mean difference|-27.0|STANDARD_ERROR_OF_MEAN|19.8||0.1899|TWO_SIDED|80.0|-53.33|-0.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-0.63|-53.33|0.1899
73970436|NCT03858634|147481204|SUPERIORITY||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|24.47||0.5763|TWO_SIDED|80.0|-55.37|24.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||24.78|-55.37|0.5763
73970437|NCT03858634|147481204|SUPERIORITY||LS mean difference|9.6|STANDARD_ERROR_OF_MEAN|14.66||0.5214|TWO_SIDED|80.0|-9.86|29.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||29.01|-9.86|0.5214
73970438|NCT03858634|147481204|SUPERIORITY||LS mean difference|-167.0|STANDARD_ERROR_OF_MEAN|105.28||0.2536|TWO_SIDED|80.0|-365.51|31.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||31.54|-365.51|0.2536
73970439|NCT03858634|147481204|SUPERIORITY||LS mean difference|-10.8|STANDARD_ERROR_OF_MEAN|5.55||0.067|TWO_SIDED|80.0|-18.2|-3.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-3.44|-18.20|0.0670
73970440|NCT03858634|147481204|SUPERIORITY||LS mean difference|-33.1|STANDARD_ERROR_OF_MEAN|34.98||0.4133|TWO_SIDED|80.0|-90.43|24.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||24.15|-90.43|0.4133
73929409|NCT03762083|147389003|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 3.|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
73929410|NCT03762083|147389005|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 14|5.6|||||TWO_SIDED|95.0|0.1|27.3||||||||27.3|0.1|
73929411|NCT03762083|147389005|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 35|0.0|||||TWO_SIDED|95.0|0.0|20.6||||||||20.6|0|
73929412|NCT04697628|147389006|SUPERIORITY||Cox Proportional Hazard|0.7||||0.0038|TWO_SIDED|95.0|0.54|0.89||Two-sided p-value calculated from stratified log-rank test.|Stratified log-rank test||Hazard Ratio (HR) was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.|||0.89|0.54|0.0038
73929413|NCT04697628|147389007|SUPERIORITY||Cox Proportional Hazard|0.67|||<|0.0001|TWO_SIDED|95.0|0.54|0.82||Two-sided p-value calculated from stratified log-rank test.|Stratified log-rank test||HR was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.|||0.82|0.54|<0.0001
73929414|NCT04697628|147389008|SUPERIORITY||Odds Ratio (OR)|4.0|||<|0.0001|TWO_SIDED|95.0|2.1|7.6|||Cochran-Mantel-Haenszel||OR calculated using Cochran-Mantel-Haenszel (CMH) method controlling for stratification factors at randomization.|||7.6|2.1|<0.0001
73929415|NCT02703636|147389016|OTHER|The MMRM model contained visit as a fixed effect, baseline MMSE score as a covariate and patient as a random effect.|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.259||0.175|TWO_SIDED|95.0|-0.87|0.16|||t-test, 2 sided||change at week 24|||0.16|-0.87|0.1750
73929416|NCT00393939|147389024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9222||||0.2651|TWO_SIDED|95.0|0.7156|1.1885||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Independent radiology assessment||1.1885|0.7156|0.2651
73929417|NCT00393939|147389024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856||||0.0753|TWO_SIDED|95.0|0.6921|1.0589||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Investigator's assessment||1.0589|0.6921|0.0753
73929418|NCT00393939|147389025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0018|TWO_SIDED|95.0|1.17|2.33||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Independent radiology assessment||2.33|1.17|0.0018
73929419|NCT00393939|147389025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0172|TWO_SIDED|95.0|1.03|2.02||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Investigator's assessment||2.02|1.03|0.0172
73929420|NCT00393939|147389027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1539||||0.8933|TWO_SIDED|95.0|0.9209|1.4458||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||||1.4458|0.9209|0.8933
73929421|NCT03778931|147389031|OTHER||Hazard Ratio (HR)|0.546||||0.0005|TWO_SIDED|95.0|0.387|0.768|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.768|0.387|0.0005
73929422|NCT03778931|147389032|OTHER||Hazard Ratio (HR)|0.697||||0.0018|TWO_SIDED|95.0|0.552|0.88|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.880|0.552|0.0018
73929423|NCT03778931|147389033|OTHER||Hazard Ratio (HR)|0.592||||0.0325|TWO_SIDED|95.0|0.361|0.958||The p-value was generated by using a two-sided stratified log-rank test.|Log Rank|||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.958|0.361|0.0325
73929424|NCT03778931|147389034|OTHER||Hazard Ratio (HR)|0.742||||0.0697|TWO_SIDED|95.0|0.536|1.025|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.|Applied a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: ESR1-mutational status (ESR1-mut vs ESR1-wt), prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no).|||1.025|0.536|0.0697
73929425|NCT00087633|147389037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.725|TWO_SIDED|95.0|-20.8|14.4|||Cochran-Mantel-Haenszel|||||14.4|-20.8|0.725
73970441|NCT03858634|147481204|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|15.44||0.9305|TWO_SIDED|80.0|-21.83|19.11|||ANCOVA|||Change at Week 2||19.11|-21.83|0.9305
73970442|NCT03858634|147481204|SUPERIORITY||LS mean difference|-160.9|STANDARD_ERROR_OF_MEAN|132.98||0.3499|TWO_SIDED|80.0|-411.65|89.86||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||89.86|-411.65|0.3499
73970443|NCT03858634|147481204|SUPERIORITY||LS mean difference|-14.0|STANDARD_ERROR_OF_MEAN|9.55||0.1588|TWO_SIDED|80.0|-26.74|-1.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-1.33|-26.74|0.1588
73970444|NCT03858634|147481204|SUPERIORITY||LS mean difference|-40.6|STANDARD_ERROR_OF_MEAN|35.19||0.3319|TWO_SIDED|80.0|-98.26|17.0||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||17.00|-98.26|0.3319
73970445|NCT03858634|147481204|SUPERIORITY||LS mean difference|7.1|STANDARD_ERROR_OF_MEAN|19.39||0.7179|TWO_SIDED|80.0|-18.59|32.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||32.80|-18.59|0.7179
73970446|NCT03858634|147481204|SUPERIORITY||LS mean difference|-193.8|STANDARD_ERROR_OF_MEAN|112.17||0.2261|TWO_SIDED|80.0|-405.34|17.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||17.67|-405.34|0.2261
73970447|NCT03858634|147481204|SUPERIORITY||LS mean difference|-30.3|STANDARD_ERROR_OF_MEAN|10.88||0.0123|TWO_SIDED|80.0|-44.75|-15.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-15.80|-44.75|0.0123
73970448|NCT03858634|147481204|SUPERIORITY||LS mean difference|-54.0|STANDARD_ERROR_OF_MEAN|35.45||0.2253|TWO_SIDED|80.0|-112.02|4.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||4.09|-112.02|0.2253
73970449|NCT03858634|147481204|SUPERIORITY||LS mean difference|6.3|STANDARD_ERROR_OF_MEAN|16.9||0.7149|TWO_SIDED|80.0|-16.14|28.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||28.66|-16.14|0.7149
73929426|NCT03985813|147389039|SUPERIORITY|||||||0.083||||||Threshold for significance P\<0.05|Chi-squared|||||||0.083
73929427|NCT03985813|147389040|SUPERIORITY||||||>|0.99||||||Threshold for statistical significance P\<0.05|Chi-squared|||||||>0.99
73929428|NCT02161718|147389047|SUPERIORITY||Hazard Ratio (HR)|0.91|STANDARD_ERROR_OF_MEAN|0.251||0.746|TWO_SIDED|95.0|0.53|1.56|||Log Rank|||||1.56|0.53|0.746
73970450|NCT03858634|147481204|SUPERIORITY||LS mean difference|-168.4|STANDARD_ERROR_OF_MEAN|109.12||0.2627|TWO_SIDED|80.0|-374.16|37.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||37.36|-374.16|0.2627
73929429|NCT02161718|147389048|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.372|TWO_SIDED|95.0|0.43|1.37|||Andersen-Gill Recurrent-Event Cox Model|||||1.37|0.43|0.372
73929430|NCT02161718|147389049|SUPERIORITY||Odds Ratio (OR)|0.99||||0.963|TWO_SIDED|95.0|0.56|1.73|||Regression, Logistic|||||1.73|0.56|0.963
73929431|NCT04108208|147389050|SUPERIORITY||Hazard Ratio (HR)|0.233|||=|0.0052|TWO_SIDED|95.0|0.077|0.705|||Log Rank|||||0.705|0.077|=0.0052
73929432|NCT00409292|147389084|SUPERIORITY_OR_OTHER|||||||0.1|||||||binomial hypothesis test|||||||0.10
73929433|NCT02350309|147389088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.15||||0.0262|ONE_SIDED|95.0|-2.12|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||||-2.12|0.0262
73929434|NCT02350309|147389088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.48|||<|0.0001|ONE_SIDED|95.0|-4.46|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||||-4.46|<0.0001
73929435|NCT02350309|147389089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0215||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||0.0215
73929436|NCT02350309|147389089|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||<0.0001
73929437|NCT02350309|147389089|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||<0.0001
73929438|NCT01205165|147389112|SUPERIORITY_OR_OTHER|||||||0||95.0||||P-value is calculated from Wilcoxon signed rank test to compare difference between baseline and week12|Wilcoxon signed rank test|||Baseline and Week 12||||0.00000
73929439|NCT02942017|147389122|SUPERIORITY||Least Square (LS) Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.019||0.016|TWO_SIDED|95.0|-4.52|-0.48|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.48|-4.52|0.0160
73929440|NCT02942017|147389123|SUPERIORITY||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|1.271||0.671|TWO_SIDED|95.0|-1.98|3.07|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.07|-1.98|0.6710
73929441|NCT02942017|147389124|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.738||0.4216|TWO_SIDED|95.0|-2.06|0.87|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.87|-2.06|0.4216
73929442|NCT02942017|147389124|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.905||0.3947|TWO_SIDED|95.0|-2.57|1.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.02|-2.57|0.3947
73929443|NCT02942017|147389124|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.962||0.328|TWO_SIDED|95.0|-2.86|0.96|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.96|-2.86|0.3280
73929444|NCT02942017|147389124|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.994||0.2522|TWO_SIDED|95.0|-3.12|0.83|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.83|-3.12|0.2522
73929445|NCT02942017|147389124|SUPERIORITY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|1.091||0.1431|TWO_SIDED|95.0|-3.78|0.55|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-3.78|0.1431
73929446|NCT02942017|147389124|SUPERIORITY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|1.113||0.0991|TWO_SIDED|95.0|-4.06|0.36|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-4.06|0.0991
73929447|NCT02942017|147389124|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|1.155||0.0389|TWO_SIDED|95.0|-4.71|-0.13|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-4.71|0.0389
73970451|NCT03858634|147481204|SUPERIORITY||LS mean difference|-36.7|STANDARD_ERROR_OF_MEAN|11.38||0.0047|TWO_SIDED|80.0|-51.87|-21.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-21.60|-51.87|0.0047
73970452|NCT03858634|147481204|SUPERIORITY||LS mean difference|-66.1|STANDARD_ERROR_OF_MEAN|38.01||0.1803|TWO_SIDED|80.0|-128.37|-3.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-3.88|-128.37|0.1803
73970453|NCT03858634|147481204|SUPERIORITY||LS mean difference|6.4|STANDARD_ERROR_OF_MEAN|17.34||0.7174|TWO_SIDED|80.0|-16.62|29.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||29.35|-16.62|0.7174
73970454|NCT03858634|147481204|SUPERIORITY||LS mean difference|-163.4|STANDARD_ERROR_OF_MEAN|103.47||0.2551|TWO_SIDED|80.0|-358.51|31.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||31.72|-358.51|0.2551
73929448|NCT02942017|147389124|SUPERIORITY||LS Mean Difference|-3.48|STANDARD_ERROR_OF_MEAN|1.108||0.0022|TWO_SIDED|95.0|-5.67|-1.28|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.28|-5.67|0.0022
73929449|NCT02942017|147389124|SUPERIORITY||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.429||0.0255|TWO_SIDED|95.0|-6.08|-0.4|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.40|-6.08|0.0255
73929450|NCT02942017|147389124|SUPERIORITY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|1.356||0.1375|TWO_SIDED|95.0|-4.73|0.66|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.66|-4.73|0.1375
73929451|NCT02942017|147389124|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.4||0.817|TWO_SIDED|95.0|-3.11|2.46|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.46|-3.11|0.8170
73929452|NCT02942017|147389125|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0168|TWO_SIDED|95.0|1.2|6.7|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.||6.7|1.2|0.0168
73929453|NCT02942017|147389125|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0482|TWO_SIDED|95.0|1.0|6.6|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.||6.6|1.0|0.0482
73929454|NCT02942017|147389125|SUPERIORITY||Odds Ratio (OR)|0.8||||0.5857|TWO_SIDED|95.0|0.3|2.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||2.0|0.3|0.5857
73929455|NCT02942017|147389126|SUPERIORITY||Odds Ratio (OR)|3.4||||0.0033|TWO_SIDED|95.0|1.5|7.9||Hour 60:|GEE method|||Hour 60: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||7.9|1.5|0.0033
73929456|NCT02942017|147389126|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0046|TWO_SIDED|95.0|1.5|9.3|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||9.3|1.5|0.0046
73970455|NCT03858634|147481204|SUPERIORITY||LS mean difference|-33.5|STANDARD_ERROR_OF_MEAN|11.36||0.0086|TWO_SIDED|80.0|-48.58|-18.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-18.36|-48.58|0.0086
73970456|NCT03858634|147481204|SUPERIORITY||LS mean difference|-56.0|STANDARD_ERROR_OF_MEAN|40.16||0.2576|TWO_SIDED|80.0|-121.78|9.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||9.78|-121.78|0.2576
74088088|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.46||||0.3017|TWO_SIDED|95.0|0.71|3.01|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.01|0.71|0.3017
73970457|NCT03858634|147481204|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|18.09||0.9722|TWO_SIDED|80.0|-24.62|23.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||23.34|-24.62|0.9722
73970458|NCT03858634|147481204|SUPERIORITY||LS mean difference|-177.4|STANDARD_ERROR_OF_MEAN|95.72||0.2051|TWO_SIDED|80.0|-357.85|3.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||3.13|-357.85|0.2051
73929457|NCT02942017|147389126|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3085|TWO_SIDED|95.0|0.3|1.5|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||1.5|0.3|0.3085
73929458|NCT02942017|147389127|SUPERIORITY||LS mean difference|-8.35|STANDARD_ERROR_OF_MEAN|2.989||0.0063|TWO_SIDED|95.0|-14.29|-2.42|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.42|-14.29|0.0063
73929459|NCT02942017|147389127|SUPERIORITY||LS mean difference|-9.75|STANDARD_ERROR_OF_MEAN|3.566||0.0074|TWO_SIDED|95.0|-16.83|-2.68|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.68|-16.83|0.0074
73970459|NCT03858634|147481204|SUPERIORITY||LS mean difference|-42.0|STANDARD_ERROR_OF_MEAN|11.99||0.0025|TWO_SIDED|80.0|-57.98|-26.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-26.08|-57.98|0.0025
73970460|NCT03858634|147481204|SUPERIORITY||LS mean difference|-65.8|STANDARD_ERROR_OF_MEAN|33.78||0.1465|TWO_SIDED|80.0|-121.14|-10.5||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-10.50|-121.14|0.1465
73970461|NCT03858634|147481204|SUPERIORITY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|17.54||0.7734|TWO_SIDED|80.0|-18.13|28.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||28.37|-18.13|0.7734
73929460|NCT02942017|147389127|SUPERIORITY||LS mean difference|1.37|STANDARD_ERROR_OF_MEAN|3.149||0.6637|TWO_SIDED|95.0|-4.88|7.63|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||7.63|-4.88|0.6637
73929461|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.154||0.5132|TWO_SIDED|95.0|-0.41|0.21|||MMRM|||Depressed Mood, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.41|0.5132
73929462|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.181||0.1672|TWO_SIDED|95.0|-0.61|0.11|||MMRM|||Depressed Mood, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.61|0.1672
73929463|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.178||0.0963|TWO_SIDED|95.0|-0.65|0.05|||MMRM|||Depressed Mood, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.65|0.0963
73929464|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.183||0.4803|TWO_SIDED|95.0|-0.49|0.23|||MMRM|||Depressed Mood, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.49|0.4803
73929465|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.191||0.0844|TWO_SIDED|95.0|-0.71|0.05|||MMRM|||Depressed Mood, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.71|0.0844
74029594|NCT03408873|147613698|OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two time-points: difference between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.||||<0.001
74029595|NCT03408873|147613699|OTHER||Mean Difference (Final Values)|0.8||||0.0566|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||0.0566
73929466|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.193||0.1325|TWO_SIDED|95.0|-0.68|0.09|||MMRM|||Depressed Mood, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.68|0.1325
73929467|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.192||0.0332|TWO_SIDED|95.0|-0.79|-0.03|||MMRM|||Depressed Mood, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.79|0.0332
73929468|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.189||0.1273|TWO_SIDED|95.0|-0.67|0.08|||MMRM|||Depressed Mood, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.67|0.1273
73929469|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.182||0.1059|TWO_SIDED|95.0|-0.66|0.06|||MMRM|||Depressed Mood, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.66|0.1059
74029596|NCT03408873|147613700|OTHER||Mean Difference (Final Values)|-3.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two time-points: difference between screen and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.||||<0.001
73929470|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.215||0.0683|TWO_SIDED|95.0|-0.82|0.03|||MMRM|||Depressed Mood, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.82|0.0683
73929471|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.232||0.4458|TWO_SIDED|95.0|-0.64|0.28|||MMRM|||Depressed Mood, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.64|0.4458
73929472|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.228||0.2905|TWO_SIDED|95.0|-0.21|0.7|||MMRM|||Depressed Mood, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.70|-0.21|0.2905
73929473|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.182||0.3096|TWO_SIDED|95.0|-0.18|0.55|||MMRM|||Depressed Mood, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-0.18|0.3096
73929474|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.165||0.1925|TWO_SIDED|95.0|-0.55|0.11|||MMRM|||Feeling of Guilt, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.55|0.1925
73929475|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.168||0.0101|TWO_SIDED|95.0|-0.77|-0.11|||MMRM|||Feeling of Guilt, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-0.77|0.0101
73970462|NCT03858634|147481204|SUPERIORITY||LS mean difference|-175.5|STANDARD_ERROR_OF_MEAN|87.45||0.1826|TWO_SIDED|80.0|-340.37|-10.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-10.56|-340.37|0.1826
73970463|NCT03858634|147481204|SUPERIORITY||LS mean difference|-39.2|STANDARD_ERROR_OF_MEAN|13.71||0.0105|TWO_SIDED|80.0|-57.4|-20.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-20.93|-57.40|0.0105
73970464|NCT03858634|147481204|SUPERIORITY||LS mean difference|-53.7|STANDARD_ERROR_OF_MEAN|40.17||0.2737|TWO_SIDED|80.0|-119.49|12.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||12.09|-119.49|0.2737
73970465|NCT03858634|147481204|SUPERIORITY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|17.77||0.8692|TWO_SIDED|80.0|-20.59|26.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||26.52|-20.59|0.8692
73970466|NCT03858634|147481204|SUPERIORITY||LS mean difference|-163.0|STANDARD_ERROR_OF_MEAN|89.64||0.2106|TWO_SIDED|80.0|-332.06|5.99||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||5.99|-332.06|0.2106
73970467|NCT03858634|147481204|SUPERIORITY||LS mean difference|-45.7|STANDARD_ERROR_OF_MEAN|14.67||0.006|TWO_SIDED|80.0|-65.19|-26.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-26.14|-65.19|0.0060
73970468|NCT03858634|147481204|SUPERIORITY||LS mean difference|-62.3|STANDARD_ERROR_OF_MEAN|36.12||0.1831|TWO_SIDED|80.0|-121.44|-3.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-3.13|-121.44|0.1831
73970469|NCT03858634|147481204|SUPERIORITY||LS mean difference|21.5|STANDARD_ERROR_OF_MEAN|16.39||0.2061|TWO_SIDED|80.0|-0.31|43.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||43.30|-0.31|0.2061
73970470|NCT03858634|147481204|SUPERIORITY||LS mean difference|-161.4|STANDARD_ERROR_OF_MEAN|87.75||0.2073|TWO_SIDED|80.0|-326.83|4.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||4.12|-326.83|0.2073
73970471|NCT03858634|147481204|SUPERIORITY||LS mean difference|-34.4|STANDARD_ERROR_OF_MEAN|15.19||0.0371|TWO_SIDED|80.0|-54.62|-14.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-14.10|-54.62|0.0371
73970472|NCT03858634|147481204|SUPERIORITY||LS mean difference|-55.2|STANDARD_ERROR_OF_MEAN|37.72||0.2393|TWO_SIDED|80.0|-117.01|6.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||6.54|-117.01|0.2393
73970473|NCT03858634|147481204|SUPERIORITY||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|19.01||0.9019|TWO_SIDED|80.0|-22.91|27.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||27.67|-22.91|0.9019
73970474|NCT03858634|147481204|SUPERIORITY||LS mean difference|-149.2|STANDARD_ERROR_OF_MEAN|81.97||0.2103|TWO_SIDED|80.0|-303.77|5.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||5.35|-303.77|0.2103
73929476|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.163||0.1546|TWO_SIDED|95.0|-0.56|0.09|||MMRM|||Feeling of Guilt, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.56|0.1546
73929477|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.168||0.0901|TWO_SIDED|95.0|-0.62|0.05|||MMRM|||Feeling of Guilt, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.62|0.0901
73929478|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.162||0.0717|TWO_SIDED|95.0|-0.62|0.03|||MMRM|||Feeling of Guilt, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.62|0.0717
73929479|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.169||0.0468|TWO_SIDED|95.0|-0.68|0.0|||MMRM|||Feeling of Guilt, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.68|0.0468
73929480|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.173||0.2222|TWO_SIDED|95.0|-0.56|0.13|||MMRM|||Feeling of Guilt, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.56|0.2222
73929481|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.156||0.0682|TWO_SIDED|95.0|-0.6|0.02|||MMRM|||Feeling of Guilt, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.60|0.0682
73929482|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0147|TWO_SIDED|95.0|-0.72|-0.08|||MMRM|||Feeling of Guilt, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.72|0.0147
73929483|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.182||0.0837|TWO_SIDED|95.0|-0.68|0.04|||MMRM|||Feeling of Guilt, Day 7:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.68|0.0837
73929484|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.179||0.5828|TWO_SIDED|95.0|-0.46|0.26|||MMRM|||Feeling of Guilt, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.46|0.5828
73929485|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.168||0.5674|TWO_SIDED|95.0|-0.43|0.24|||MMRM|||Feeling of Guilt, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.43|0.5674
73929486|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.145||0.4613|TWO_SIDED|95.0|-0.18|0.4|||MMRM|||Feeling of Guilt, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.18|0.4613
73929487|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.082||0.324|TWO_SIDED|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 2:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.24|0.3240
73970475|NCT03858634|147481204|SUPERIORITY||LS mean difference|-22.1|STANDARD_ERROR_OF_MEAN|15.2||0.1634|TWO_SIDED|80.0|-42.4|-1.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-1.88|-42.40|0.1634
73862776|NCT01264770|147271518|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.004|TWO_SIDED|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.40|-1.04|0.004
73862777|NCT01264770|147271519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.05||||0.005|TWO_SIDED|90.0|1.59|5.86|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||5.86|1.59|0.005
73862778|NCT01264770|147271519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.11|||<|0.001|TWO_SIDED|90.0|2.1|8.05|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.05|2.10|<0.001
73862779|NCT01264770|147271519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.335|TWO_SIDED|90.0|0.76|2.83|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.83|0.76|0.335
73862780|NCT01264770|147271520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.007|TWO_SIDED|90.0|0.2|0.68|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.68|0.20|0.007
73862781|NCT01264770|147271520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.051|TWO_SIDED|90.0|0.26|0.89|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.89|0.26|0.051
73862782|NCT01264770|147271520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.004|TWO_SIDED|90.0|0.2|0.65|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.65|0.20|0.004
73862783|NCT01264770|147271521|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.29|||<|0.001|TWO_SIDED|90.0|0.17|0.4||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.40|0.17|<0.001
73862784|NCT01264770|147271521|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.3|||<|0.001|TWO_SIDED|90.0|0.18|0.43||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.43|0.18|<0.001
73862785|NCT01264770|147271521|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.19||||0.007|TWO_SIDED|90.0|0.07|0.31||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.31|0.07|0.007
73862786|NCT01264770|147271521|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.16||||0.049|TWO_SIDED|90.0|-0.3|-0.03||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.03|-0.30|0.049
73970476|NCT03858634|147481204|SUPERIORITY||LS mean difference|-48.6|STANDARD_ERROR_OF_MEAN|36.28||0.2727|TWO_SIDED|80.0|-108.04|10.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||10.80|-108.04|0.2727
73970477|NCT03858634|147481204|SUPERIORITY||LS mean difference|-9.6|STANDARD_ERROR_OF_MEAN|17.29||0.5839|TWO_SIDED|80.0|-32.65|13.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||13.36|-32.65|0.5839
73970478|NCT03858634|147481204|SUPERIORITY||LS mean difference|-167.8|STANDARD_ERROR_OF_MEAN|76.58||0.1597|TWO_SIDED|80.0|-312.25|-23.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-23.45|-312.25|0.1597
73970479|NCT03858634|147481204|SUPERIORITY||LS mean difference|-27.1|STANDARD_ERROR_OF_MEAN|16.27||0.1138|TWO_SIDED|80.0|-48.81|-5.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-5.43|-48.81|0.1138
73970480|NCT03858634|147481204|SUPERIORITY||LS mean difference|-62.0|STANDARD_ERROR_OF_MEAN|24.93||0.0888|TWO_SIDED|80.0|-102.78|-21.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-21.13|-102.78|0.0888
73929488|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.082||0.3023|TWO_SIDED|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.24|0.3023
73929489|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.4127|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.4127
73929490|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.082||0.2819|TWO_SIDED|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.25|0.2819
73929491|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3884|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3884
73929492|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.082||0.275|TWO_SIDED|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.25|0.2750
73929493|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.082||0.1811|TWO_SIDED|95.0|-0.27|0.05|||MMRM|||Suicide, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.27|0.1811
73929494|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3854|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3854
73929495|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3822|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3822
73929496|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.082||0.9255|TWO_SIDED|95.0|-0.17|0.15|||MMRM|||Suicide, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.17|0.9255
73929497|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.091||0.6714|TWO_SIDED|95.0|-0.14|0.22|||MMRM|||Suicide, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.14|0.6714
73970481|NCT03858634|147481204|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|18.19||0.9741|TWO_SIDED|80.0|-24.79|23.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||23.60|-24.79|0.9741
73970482|NCT03858634|147481204|SUPERIORITY||LS mean difference|-159.2|STANDARD_ERROR_OF_MEAN|65.42||0.1354|TWO_SIDED|80.0|-282.59|-35.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-35.87|-282.59|0.1354
73970483|NCT03858634|147481204|SUPERIORITY||LS mean difference|-26.5|STANDARD_ERROR_OF_MEAN|17.21||0.1425|TWO_SIDED|80.0|-49.41|-3.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-3.52|-49.41|0.1425
73970484|NCT03858634|147481204|SUPERIORITY||LS mean difference|-54.6|STANDARD_ERROR_OF_MEAN|26.61||0.1326|TWO_SIDED|80.0|-98.18|-11.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-11.01|-98.18|0.1326
73970485|NCT03858634|147481204|OTHER||LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|20.87||0.8433|TWO_SIDED|80.0|-31.95|23.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||23.58|-31.95|0.8433
73862787|NCT01264770|147271521|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.02||||0.803|TWO_SIDED|90.0|-0.16|0.12||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|-0.16|0.803
73929498|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.091||0.9838|TWO_SIDED|95.0|-0.18|0.18|||MMRM|||Suicide, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.18|0.9838
73929499|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.083||0.8884|TWO_SIDED|95.0|-0.17|0.15|||MMRM|||Suicide, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.17|0.8884
73929500|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.097||0.6996|TWO_SIDED|95.0|-0.23|0.16|||MMRM|||Insomnia-Early, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.23|0.6996
73929501|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.121||0.4426|TWO_SIDED|95.0|-0.15|0.33|||MMRM|||Insomnia-Early, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.15|0.4426
73929502|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.11||0.8743|TWO_SIDED|95.0|-0.2|0.24|||MMRM|||Insomnia-Early, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.20|0.8743
73929503|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.118||0.3498|TWO_SIDED|95.0|-0.12|0.35|||MMRM|||Insomnia-Early, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.12|0.3498
73929504|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.151||0.0839|TWO_SIDED|95.0|-0.56|0.04|||MMRM|||Insomnia-Early, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.56|0.0839
73929505|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.157||0.2595|TWO_SIDED|95.0|-0.49|0.13|||MMRM|||Insomnia-Early, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.49|0.2595
73970486|NCT03858634|147481204|SUPERIORITY||LS mean difference|-130.8|STANDARD_ERROR_OF_MEAN|38.5||0.0768|TWO_SIDED|80.0|-203.39|-58.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-58.19|-203.39|0.0768
73929506|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.168||0.056|TWO_SIDED|95.0|-0.66|0.01|||MMRM|||Insomnia-Early, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.66|0.0560
73929507|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.6187|TWO_SIDED|95.0|-0.45|0.27|||MMRM|||Insomnia-Early, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.45|0.6187
73929508|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.163||0.0187|TWO_SIDED|95.0|-0.72|-0.07|||MMRM|||Insomnia-Early, Hour 72 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.72|0.0187
73929509|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.18||0.1531|TWO_SIDED|95.0|-0.62|0.1|||MMRM|||Insomnia-Early, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.62|0.1531
73929510|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.197||0.3341|TWO_SIDED|95.0|-0.58|0.2|||MMRM|||Insomnia-Early, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.58|0.3341
73929511|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.216||0.8969|TWO_SIDED|95.0|-0.4|0.46|||MMRM|||Insomnia-Early, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.40|0.8969
73929512|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.174||0.5862|TWO_SIDED|95.0|-0.25|0.44|||MMRM|||Insomnia-Early, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.25|0.5862
73929513|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.117||0.3776|TWO_SIDED|95.0|-0.13|0.34|||MMRM|||Insomnia-Middle, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.13|0.3776
73929514|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.9029|TWO_SIDED|95.0|-0.26|0.23|||MMRM|||Insomnia-Middle, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.26|0.9029
73929515|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.121||0.6173|TWO_SIDED|95.0|-0.18|0.3|||MMRM|||Insomnia-Middle, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.18|0.6173
73929516|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.124||0.2433|TWO_SIDED|95.0|-0.1|0.39|||MMRM|||Insomnia-Middle, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.10|0.2433
73970487|NCT03858634|147481204|SUPERIORITY||LS mean difference|-18.6|STANDARD_ERROR_OF_MEAN|18.69||0.3341|TWO_SIDED|80.0|-43.49|6.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||6.34|-43.49|0.3341
73929517|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.139||0.0234|TWO_SIDED|95.0|-0.59|-0.04|||MMRM|||Insomnia-Middle, Hour 24 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.59|0.0234
73929518|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.139||0.054|TWO_SIDED|95.0|-0.55|0.0|||MMRM|||Insomnia-Middle, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.55|0.0540
73970488|NCT03858634|147481206|SUPERIORITY||LS mean difference|-40.9|STANDARD_ERROR_OF_MEAN|40.82||0.4995|TWO_SIDED|80.0|-166.52|84.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||84.74|-166.52|0.4995
73970489|NCT03858634|147481206|SUPERIORITY||LS mean difference|-3.7|STANDARD_ERROR_OF_MEAN|9.59||0.7071|TWO_SIDED|80.0|-16.37|9.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||9.06|-16.37|0.7071
73970490|NCT03858634|147481206|SUPERIORITY||LS mean difference|-52.5|STANDARD_ERROR_OF_MEAN|9.39||0.0305|TWO_SIDED|80.0|-70.18|-34.77||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-34.77|-70.18|0.0305
73970491|NCT03858634|147481206|SUPERIORITY||LS mean difference|-6.6|STANDARD_ERROR_OF_MEAN|9.33||0.4884|TWO_SIDED|80.0|-19.01|5.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||5.81|-19.01|0.4884
74088089|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.4||||0.216|TWO_SIDED|95.0|0.6|9.58|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.58|0.60|0.2160
74088090|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.33||||0.7174|TWO_SIDED|95.0|0.29|6.08|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.08|0.29|0.7174
74088091|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.04|||<|0.0001|TWO_SIDED|95.0|1.45|2.87|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.45|<.0001
74088092|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0006|TWO_SIDED|95.0|1.29|2.54|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.54|1.29|0.0006
74088093|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0024|TWO_SIDED|95.0|1.23|2.65|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.65|1.23|0.0024
74088094|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.17|||<|0.0001|TWO_SIDED|95.0|1.49|3.16|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.16|1.49|<.0001
73862788|NCT01264770|147271521|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.24||||0.003|TWO_SIDED|90.0|-0.37|-0.1||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.10|-0.37|0.003
73929519|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.144||0.0406|TWO_SIDED|95.0|-0.58|-0.01|||MMRM|||Insomnia-Middle, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.58|0.0406
73929520|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.132||0.0295|TWO_SIDED|95.0|-0.56|-0.03|||MMRM|||Insomnia-Middle, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.56|0.0295
73929521|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.135||0.0925|TWO_SIDED|95.0|-0.5|0.04|||MMRM|||Insomnia-Middle, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.50|0.0925
73929522|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.152||0.1631|TWO_SIDED|95.0|-0.52|0.09|||MMRM|||Insomnia-Middle, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.52|0.1631
73929523|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.185||0.2213|TWO_SIDED|95.0|-0.6|0.14|||MMRM|||Insomnia-Middle, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.60|0.2213
73970492|NCT03858634|147481206|SUPERIORITY||LS mean difference|-45.3|STANDARD_ERROR_OF_MEAN|31.63||0.2885|TWO_SIDED|80.0|-104.93|14.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||14.35|-104.93|0.2885
73970493|NCT03858634|147481206|SUPERIORITY||LS mean difference|5.2|STANDARD_ERROR_OF_MEAN|11.24||0.6505|TWO_SIDED|80.0|-9.73|20.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||20.06|-9.73|0.6505
73970494|NCT03858634|147481206|SUPERIORITY||LS mean difference|-72.1|STANDARD_ERROR_OF_MEAN|5.72||0.0062|TWO_SIDED|80.0|-82.91|-61.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-61.34|-82.91|0.0062
73970495|NCT03858634|147481206|SUPERIORITY||LS mean difference|-19.6|STANDARD_ERROR_OF_MEAN|9.62||0.0571|TWO_SIDED|80.0|-32.34|-6.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.76|-32.34|0.0571
73970496|NCT03858634|147481206|SUPERIORITY||LS mean difference|-50.1|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|||||||||Change at Week 6||||
73929524|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.189||0.9175|TWO_SIDED|95.0|-0.36|0.39|||MMRM|||Insomnia-Middle, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.36|0.9175
73929525|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.165||0.6763|TWO_SIDED|95.0|-0.4|0.26|||MMRM|||Insomnia-Middle, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.40|0.6763
73929526|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.121||0.3805|TWO_SIDED|95.0|-0.13|0.35|||MMRM|||Insomnia-Late, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.13|0.3805
73929527|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.127||0.6073|TWO_SIDED|95.0|-0.19|0.32|||MMRM|||Insomnia-Late, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.19|0.6073
73929528|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.119||0.7848|TWO_SIDED|95.0|-0.27|0.2|||MMRM|||Insomnia-Late, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.27|0.7848
73929529|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.9038|TWO_SIDED|95.0|-0.25|0.23|||MMRM|||Insomnia-Late, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.25|0.9038
73929530|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.134|STANDARD_ERROR_OF_MEAN|0.134||0.6869|TWO_SIDED|95.0|-0.32|0.21|||MMRM|||Insomnia-Late, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.32|0.6869
73929531|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.139||0.9272|TWO_SIDED|95.0|-0.26|0.29|||MMRM|||Insomnia-Late, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.26|0.9272
73929532|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.131||0.6931|TWO_SIDED|95.0|-0.31|0.21|||MMRM|||Insomnia-Late, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.31|0.6931
74088095|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0373|TWO_SIDED|95.0|1.04|3.14|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.04|0.0373
74088096|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.17||||0.0046|TWO_SIDED|95.0|1.27|3.72|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.27|0.0046
74088097|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0683|TWO_SIDED|95.0|0.92|9.47|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.47|0.92|0.0683
74088098|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0214|TWO_SIDED|95.0|1.22|11.66|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||11.66|1.22|0.0214
73970497|NCT03858634|147481206|SUPERIORITY||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|10.65||0.6927|TWO_SIDED|80.0|-18.38|9.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||9.84|-18.38|0.6927
73862789|NCT01264770|147271522|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.059|TWO_SIDED|90.0|0.01|0.18||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.01|0.059
73862790|NCT01264770|147271522|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.071|TWO_SIDED|90.0|0.01|0.17||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.17|0.01|0.071
73929533|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.132||0.8262|TWO_SIDED|95.0|-0.29|0.23|||MMRM|||Insomnia-Late, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.29|0.8262
73970498|NCT03858634|147481206|SUPERIORITY||LS mean difference|-65.6|STANDARD_ERROR_OF_MEAN|4.08||0.0038|TWO_SIDED|80.0|-73.33|-57.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-57.94|-73.33|0.0038
73970499|NCT03858634|147481206|SUPERIORITY||LS mean difference|-17.4|STANDARD_ERROR_OF_MEAN|9.82||0.094|TWO_SIDED|80.0|-30.43|-4.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-4.30|-30.43|0.0940
73970500|NCT03858634|147481206|SUPERIORITY||LS mean difference|-72.4|STANDARD_ERROR_OF_MEAN|19.73||0.1694|TWO_SIDED|80.0|-133.1|-11.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-11.65|-133.10|0.1694
73970501|NCT03858634|147481206|SUPERIORITY||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|10.07||0.7811|TWO_SIDED|80.0|-10.5|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||16.18|-10.50|0.7811
73970502|NCT03858634|147481206|SUPERIORITY||LS mean difference|-68.2|STANDARD_ERROR_OF_MEAN|2.28||0.0011|TWO_SIDED|80.0|-72.51|-63.91||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-63.91|-72.51|0.0011
73970503|NCT03858634|147481206|SUPERIORITY||LS mean difference|-23.4|STANDARD_ERROR_OF_MEAN|9.52||0.0245|TWO_SIDED|80.0|-36.02|-10.7||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-10.70|-36.02|0.0245
73970504|NCT03858634|147481206|SUPERIORITY||LS mean difference|-61.8|STANDARD_ERROR_OF_MEAN|5.87||0.0603|TWO_SIDED|80.0|-79.88|-43.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-43.74|-79.88|0.0603
73970505|NCT03858634|147481206|SUPERIORITY||LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|9.89||0.4365|TWO_SIDED|80.0|-5.29|21.04||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||21.04|-5.29|0.4365
73970506|NCT03858634|147481206|SUPERIORITY||LS mean difference|-68.7|STANDARD_ERROR_OF_MEAN|10.3||0.0218|TWO_SIDED|80.0|-88.11|-49.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-49.26|-88.11|0.0218
73970507|NCT03858634|147481206|SUPERIORITY||LS mean difference|-19.5|STANDARD_ERROR_OF_MEAN|12.07||0.1238|TWO_SIDED|80.0|-35.65|-3.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-3.45|-35.65|0.1238
73970508|NCT03858634|147481206|SUPERIORITY||LS mean difference|-54.8|STANDARD_ERROR_OF_MEAN|23.38||0.1437|TWO_SIDED|80.0|-98.88|-10.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-10.72|-98.88|0.1437
73970509|NCT03858634|147481206|SUPERIORITY||LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|10.14||0.9279|TWO_SIDED|80.0|-12.56|14.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||14.43|-12.56|0.9279
73970510|NCT03858634|147481206|SUPERIORITY||LS mean difference|-59.5|STANDARD_ERROR_OF_MEAN|9.67||0.0254|TWO_SIDED|80.0|-77.69|-41.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-41.24|-77.69|0.0254
73970511|NCT03858634|147481206|SUPERIORITY||LS mean difference|-18.8|STANDARD_ERROR_OF_MEAN|10.8||0.0994|TWO_SIDED|80.0|-33.23|-4.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-4.43|-33.23|0.0994
73970512|NCT03858634|147481206|SUPERIORITY||LS mean difference|-45.7|STANDARD_ERROR_OF_MEAN|39.36||0.3656|TWO_SIDED|80.0|-119.9|28.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||28.54|-119.90|0.3656
73970513|NCT03858634|147481206|SUPERIORITY||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|8.92||0.7465|TWO_SIDED|80.0|-14.79|8.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||8.94|-14.79|0.7465
73970514|NCT03858634|147481206|SUPERIORITY||LS mean difference|-82.3|STANDARD_ERROR_OF_MEAN|10.3||0.0153|TWO_SIDED|80.0|-101.75|-62.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-62.90|-101.75|0.0153
73970515|NCT03858634|147481206|SUPERIORITY||LS mean difference|-16.6|STANDARD_ERROR_OF_MEAN|12.97||0.2184|TWO_SIDED|80.0|-33.88|0.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||0.72|-33.88|0.2184
73970516|NCT03858634|147481206|SUPERIORITY||LS mean difference|-8.1|STANDARD_ERROR_OF_MEAN|25.78||0.7726|TWO_SIDED|80.0|-50.37|34.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||34.07|-50.37|0.7726
73862791|NCT01264770|147271522|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.01||||0.758|TWO_SIDED|90.0|-0.05|0.07||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|-0.05|0.758
73862792|NCT01264770|147271522|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.12||||0.114|TWO_SIDED|90.0|-0.24|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.00|-0.24|0.114
73862793|NCT01264770|147271522|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.14||||0.078|TWO_SIDED|90.0|-0.26|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.01|-0.26|0.078
73862794|NCT01264770|147271522|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.21||||0.003|TWO_SIDED|90.0|-0.32|-0.09||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.09|-0.32|0.003
73862795|NCT01264770|147271523|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.02||||0.46|TWO_SIDED|90.0|-0.07|0.03||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.03|-0.07|0.460
73929534|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.141||0.0749|TWO_SIDED|95.0|-0.54|0.03|||MMRM|||Insomnia-Late, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.54|0.0749
73929535|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.135||0.1923|TWO_SIDED|95.0|-0.45|0.09|||MMRM|||Insomnia-Late, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.45|0.1923
73929536|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.176||0.0326|TWO_SIDED|95.0|-0.73|-0.03|||MMRM|||Insomnia-Late, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.73|0.0326
73929537|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.171||0.444|TWO_SIDED|95.0|-0.47|0.21|||MMRM|||Insomnia-Late, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.47|0.4440
73970517|NCT03858634|147481206|SUPERIORITY||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|12.66||0.476|TWO_SIDED|80.0|-26.07|7.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||7.63|-26.07|0.4760
73970518|NCT03858634|147481206|SUPERIORITY||LS mean difference|-82.1|STANDARD_ERROR_OF_MEAN|9.12||0.0121|TWO_SIDED|80.0|-99.26|-64.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-64.87|-99.26|0.0121
73970519|NCT03858634|147481206|SUPERIORITY||LS mean difference|-13.0|STANDARD_ERROR_OF_MEAN|13.06||0.3329|TWO_SIDED|80.0|-30.43|4.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||4.40|-30.43|0.3329
73970520|NCT03858634|147481206|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|28.46||0.9564|TWO_SIDED|80.0|-48.31|44.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||44.92|-48.31|0.9564
73970521|NCT03858634|147481206|SUPERIORITY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|13.49||0.5661|TWO_SIDED|80.0|-25.84|10.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||10.06|-25.84|0.5661
74088099|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.3|2.58|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.30|0.0006
73929538|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.134||0.7057|TWO_SIDED|95.0|-0.32|0.22|||MMRM|||Insomnia-Late, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.32|0.7057
73929539|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.137||0.2865|TWO_SIDED|95.0|-0.42|0.13|||MMRM|||Work and Activities, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.42|0.2865
73929540|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.9475|TWO_SIDED|95.0|-0.33|0.35|||MMRM|||Work and Activities, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.33|0.9475
73929541|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.185||0.188|TWO_SIDED|95.0|-0.61|0.12|||MMRM|||Work and Activities, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.61|0.1880
73929542|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.203||0.595|TWO_SIDED|95.0|-0.51|0.29|||MMRM|||Work and Activities, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.51|0.5950
73929543|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.2||0.9636|TWO_SIDED|95.0|-0.39|0.41|||MMRM|||Work and Activities, Hour 24 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.41|-0.39|0.9636
74088100|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0048|TWO_SIDED|95.0|1.16|2.28|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.28|1.16|0.0048
74088101|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0012|TWO_SIDED|95.0|1.27|2.65|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.65|1.27|0.0012
74088102|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.68|3.47|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.47|1.68|<.0001
74088103|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0537|TWO_SIDED|95.0|0.99|2.74|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.74|0.99|0.0537
74088104|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0001|TWO_SIDED|95.0|1.58|4.13|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.13|1.58|0.0001
73970522|NCT03858634|147481206|SUPERIORITY||LS mean difference|-82.1|STANDARD_ERROR_OF_MEAN|9.12||0.0121|TWO_SIDED|80.0|-99.26|-64.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-64.87|-99.26|0.0121
73970523|NCT03858634|147481206|SUPERIORITY||LS mean difference|-11.1|STANDARD_ERROR_OF_MEAN|13.7||0.4275|TWO_SIDED|80.0|-29.4|7.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||7.13|-29.40|0.4275
73970524|NCT03858634|147481211|SUPERIORITY||LS mean difference|-27.9|STANDARD_ERROR_OF_MEAN|40.54||0.5403|TWO_SIDED|80.0|-94.32|38.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||38.46|-94.32|0.5403
73970525|NCT03858634|147481211|SUPERIORITY||LS mean difference|376.1|STANDARD_ERROR_OF_MEAN|631.83||0.5587|TWO_SIDED|80.0|-462.83|1214.97||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||1214.97|-462.83|0.5587
73970526|NCT03858634|147481211|SUPERIORITY||LS mean difference|-67.7|STANDARD_ERROR_OF_MEAN|72.99||0.4516|TWO_SIDED|80.0|-205.33|69.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||69.93|-205.33|0.4516
74088105|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1155|TWO_SIDED|95.0|0.82|6.27|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.27|0.82|0.1155
73929544|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.196||0.5836|TWO_SIDED|95.0|-0.5|0.28|||MMRM|||Work and Activities, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.50|0.5836
73929545|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.184||0.1568|TWO_SIDED|95.0|-0.63|0.1|||MMRM|||Work and Activities, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.63|0.1568
73929546|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.177||0.0155|TWO_SIDED|5.0|-0.79|-0.09|||Wilcoxon (Mann-Whitney)|||Work and Activities, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.79|0.0155
73929547|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.192||0.0504|TWO_SIDED|95.0|-0.76|0.0|||MMRM|||Work and Activities, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.76|0.0504
73929548|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.212||0.1865|TWO_SIDED|95.0|-0.7|0.14|||MMRM|||Work and Activities, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.70|0.1865
73929549|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.22||0.0518|TWO_SIDED|95.0|-0.87|0.0|||MMRM|||Work and Activities, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.87|0.0518
73929550|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.239||0.833|TWO_SIDED|95.0|-0.42|0.53|||MMRM|||Work and Activities, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.53|-0.42|0.8330
73929551|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.191||0.844|TWO_SIDED|95.0|-0.34|0.42|||MMRM|||Work and Activities, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.34|0.8440
73929552|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.121||0.4602|TWO_SIDED|95.0|-0.15|0.33|||MMRM|||Retardation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.15|0.4602
73929553|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.117||0.0891|TWO_SIDED|95.0|-0.03|0.43|||MMRM|||Retardation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.03|0.0891
73929554|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.117||0.3088|TWO_SIDED|95.0|-0.11|0.35|||MMRM|||Retardation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.11|0.3088
73970527|NCT03858634|147481211|SUPERIORITY||LS mean difference|-12.5|STANDARD_ERROR_OF_MEAN|9.5||0.2052|TWO_SIDED|80.0|-25.13|0.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||0.15|-25.13|0.2052
73970528|NCT03858634|147481211|SUPERIORITY||LS mean difference|-59.4|STANDARD_ERROR_OF_MEAN|38.89||0.224|TWO_SIDED|80.0|-123.09|4.28||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||4.28|-123.09|0.2240
73970529|NCT03858634|147481211|SUPERIORITY||LS mean difference|39.5|STANDARD_ERROR_OF_MEAN|48.33||0.4242|TWO_SIDED|80.0|-24.7|103.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||103.65|-24.70|0.4242
73862796|NCT01264770|147271523|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.0||||0.903|TWO_SIDED|90.0|-0.05|0.06||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.06|-0.05|0.903
73929555|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.112||0.856|TWO_SIDED|95.0|-0.24|0.2|||MMRM|||Retardation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.24|0.8560
73929556|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.125||0.9702|TWO_SIDED|95.0|-0.24|0.25|||MMRM|||Retardation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.24|0.9702
73929557|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.114||0.8001|TWO_SIDED|95.0|-0.25|0.2|||MMRM|||Retardation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.25|0.8001
73929558|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.109||0.3223|TWO_SIDED|95.0|-0.11|0.32|||MMRM|||Retardation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.32|-0.11|0.3223
73929559|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.089||0.3385|TWO_SIDED|95.0|-0.26|0.09|||MMRM|||Retardation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.09|-0.26|0.3385
73929560|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7003|TWO_SIDED|95.0|-0.16|0.24|||MMRM|||Retardation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.24|-0.16|0.7003
73929561|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.099||0.0311|TWO_SIDED|95.0|-0.41|-0.02|||MMRM|||Retardation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||-0.02|-0.41|0.0311
73929562|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.079||0.1976|TWO_SIDED|95.0|-0.26|0.06|||MMRM|||Retardation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.06|-0.26|0.1976
73929563|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.092||0.5489|TWO_SIDED|95.0|-0.24|0.13|||MMRM|||Retardation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.13|-0.24|0.5489
73929564|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.075||0.7992|TWO_SIDED|95.0|-0.17|0.13|||MMRM|||Retardation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.13|-0.17|0.7992
73970530|NCT03858634|147481211|SUPERIORITY||LS mean difference|-77.2|STANDARD_ERROR_OF_MEAN|78.61||0.4295|TWO_SIDED|80.0|-225.44|71.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||71.01|-225.44|0.4295
73970531|NCT03858634|147481211|SUPERIORITY||LS mean difference|-18.7|STANDARD_ERROR_OF_MEAN|14.97||0.2272|TWO_SIDED|80.0|-38.64|1.2||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||1.20|-38.64|0.2272
73970532|NCT03858634|147481211|SUPERIORITY||LS mean difference|-55.1|STANDARD_ERROR_OF_MEAN|48.9||0.3416|TWO_SIDED|80.0|-135.23|24.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||24.95|-135.23|0.3416
73862797|NCT01264770|147271523|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.03||||0.172|TWO_SIDED|90.0|-0.08|0.01||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.01|-0.08|0.172
73862798|NCT01264770|147271523|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.11||||0.082|TWO_SIDED|90.0|-0.21|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.01|-0.21|0.082
73929565|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.103||0.0573|TWO_SIDED|95.0|-0.4|0.01|||MMRM|||Agitation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.40|0.0573
73929566|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0431|TWO_SIDED|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.44|0.0431
74029597|NCT03408873|147613701|OTHER||Mean Difference (Final Values)|17.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
74029598|NCT03408873|147613702|OTHER||Mean Difference (Final Values)|16.9|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
74029599|NCT03408873|147613703|OTHER||Mean Difference (Final Values)|14.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
74029600|NCT03408873|147613704|OTHER||Mean Difference (Final Values)|19.2|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
73929567|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.108||0.006|TWO_SIDED|95.0|-0.52|-0.09|||MMRM|||Agitation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.52|0.0060
73929568|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.127||0.0215|TWO_SIDED|95.0|-0.55|-0.04|||MMRM|||Agitation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.55|0.0215
73929569|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.109||0.0422|TWO_SIDED|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.44|0.0422
73929570|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.126||0.0433|TWO_SIDED|95.0|-0.51|-0.01|||MMRM|||Agitation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.51|0.0433
73929571|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.118||0.0051|TWO_SIDED|95.0|-0.57|-0.1|||MMRM|||Agitation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.57|0.0051
73929572|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.133||0.0973|TWO_SIDED|95.0|-0.48|0.04|||MMRM|||Agitation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.48|0.0973
73929573|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.126||0.0036|TWO_SIDED|95.0|-0.63|-0.13|||MMRM|||Agitation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-0.63|0.0036
73929574|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.131||0.0498|TWO_SIDED|95.0|-0.52|0.0|||MMRM|||Agitation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.52|0.0498
73929575|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.147||0.5111|TWO_SIDED|95.0|-0.39|0.2|||MMRM|||Agitation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.39|0.5111
73929576|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.155||0.5839|TWO_SIDED|95.0|-0.39|0.22|||MMRM|||Agitation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.39|0.5839
73929577|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.1905|TWO_SIDED|95.0|-0.33|0.07|||MMRM|||Agitation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.33|0.1905
73929578|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.162||0.1767|TWO_SIDED|95.0|-0.54|0.1|||MMRM|||Anxiety Psychic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.54|0.1767
73929579|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.5182|TWO_SIDED|95.0|-0.47|0.24|||MMRM|||Anxiety Psychic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.47|0.5182
73929580|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.185||0.393|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3930
74088106|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0271|TWO_SIDED|95.0|1.13|7.96|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.96|1.13|0.0271
73929581|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.189||0.5212|TWO_SIDED|95.0|-0.5|0.25|||MMRM|||Anxiety Psychic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.50|0.5212
73929582|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.184||0.4741|TWO_SIDED|95.0|-0.5|0.23|||MMRM|||Anxiety Psychic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.50|0.4741
73862799|NCT01264770|147271523|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.11||||0.092|TWO_SIDED|90.0|-0.21|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.00|-0.21|0.092
73862800|NCT01264770|147271523|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.17||||0.002|TWO_SIDED|90.0|-0.27|-0.08||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.08|-0.27|0.002
73929583|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.186||0.4482|TWO_SIDED|95.0|-0.51|0.23|||MMRM|||Anxiety Psychic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.51|0.4482
73929584|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.187||0.0963|TWO_SIDED|95.0|-0.69|0.06|||MMRM|||Anxiety Psychic, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.69|0.0963
73929585|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.171||0.003|TWO_SIDED|95.0|-0.86|-0.18|||MMRM|||Anxiety Psychic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.18|-0.86|0.0030
73929586|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.177||0.1116|TWO_SIDED|95.0|-0.63|0.07|||MMRM|||Anxiety Psychic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.63|0.1116
73929587|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.173||0.004|TWO_SIDED|95.0|-0.86|-0.17|||MMRM|||Anxiety Psychic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-0.86|0.0040
73929588|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.244||0.8253|TWO_SIDED|95.0|-0.54|0.43|||MMRM|||Anxiety Psychic, Day 14 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.54|0.8253
73929589|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.209||0.5795|TWO_SIDED|95.0|-0.3|0.53|||MMRM|||Anxiety Psychic, Day 21 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.53|-0.30|0.5795
74029601|NCT03408873|147613705|OTHER||Mean Difference (Final Values)|-0.5||||0.73|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.73
74088107|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0007|TWO_SIDED|95.0|1.3|2.63|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.63|1.30|0.0007
74088108|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0011|TWO_SIDED|95.0|1.26|2.56|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.56|1.26|0.0011
74088109|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0009|TWO_SIDED|95.0|1.27|2.52|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.52|1.27|0.0009
73862801|NCT01264770|147271524|SUPERIORITY_OR_OTHER||Treatment difference|23.39|||<|0.001|TWO_SIDED|90.0|9.57|40.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||40.00|9.57|<0.001
73862802|NCT01264770|147271524|SUPERIORITY_OR_OTHER||Treatment difference|22.97||||0.006|TWO_SIDED|90.0|7.84|38.34|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||38.34|7.84|0.006
73862803|NCT01264770|147271524|SUPERIORITY_OR_OTHER||Treatment difference|5.72||||0.234|TWO_SIDED|90.0|-3.2|21.68|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||21.68|-3.20|0.234
73862804|NCT01264770|147271525|SUPERIORITY_OR_OTHER||Treatment difference|-13.72||||0.03|TWO_SIDED|90.0|-25.01|0.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.00|-25.01|0.030
73929590|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.182||0.4032|TWO_SIDED|95.0|-0.21|0.51|||MMRM|||Anxiety Psychic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.51|-0.21|0.4032
73929591|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.133||0.6117|TWO_SIDED|95.0|-0.33|0.2|||MMRM|||Anxiety Somatic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.33|0.6117
73929592|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4716|TWO_SIDED|95.0|-0.35|0.16|||MMRM|||Anxiety Somatic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.35|0.4716
73862805|NCT01264770|147271525|SUPERIORITY_OR_OTHER||Treatment difference|-9.49||||0.207|TWO_SIDED|90.0|-25.0|6.96|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||6.96|-25.00|0.207
73929593|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.136||0.6041|TWO_SIDED|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.34|0.6041
73970533|NCT03858634|147481211|SUPERIORITY||LS mean difference|57.6|STANDARD_ERROR_OF_MEAN|69.75||0.4192|TWO_SIDED|80.0|-35.02|150.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||150.19|-35.02|0.4192
73862806|NCT01264770|147271525|SUPERIORITY_OR_OTHER||Treatment difference|-19.53||||0.002|TWO_SIDED|90.0|-30.01|-6.25|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-6.25|-30.01|0.002
73862807|NCT01264770|147271526|SUPERIORITY_OR_OTHER||Treatment difference|0.24||||0.007|TWO_SIDED|90.0|0.09|0.38|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.38|0.09|0.007
73862808|NCT01264770|147271526|SUPERIORITY_OR_OTHER||Treatment difference|0.22||||0.016|TWO_SIDED|90.0|0.07|0.37|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.37|0.07|0.016
73929594|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.132||0.0424|TWO_SIDED|95.0|-0.53|-0.01|||MMRM|||Anxiety Somatic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.53|0.0424
73970534|NCT03858634|147481211|SUPERIORITY||LS mean difference|-66.8|STANDARD_ERROR_OF_MEAN|87.42||0.5245|TWO_SIDED|80.0|-231.66|98.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||98.02|-231.66|0.5245
73929595|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.138||0.7622|TWO_SIDED|95.0|-0.32|0.23|||MMRM|||Anxiety Somatic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.32|0.7622
73929596|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2689|TWO_SIDED|95.0|-0.4|0.11|||MMRM|||Anxiety Somatic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.40|0.2689
73929597|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.134||0.211|TWO_SIDED|95.0|-0.44|0.1|||MMRM|||Anxiety Somatic, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.44|0.2110
73929598|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.135||0.5873|TWO_SIDED|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.34|0.5873
73929599|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.114||0.045|TWO_SIDED|95.0|-0.46|-0.01|||MMRM|||Anxiety Somatic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.46|0.0450
73929600|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.152||0.0847|TWO_SIDED|95.0|-0.57|0.04|||MMRM|||Anxiety Somatic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.57|0.0847
73929601|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.189||0.2522|TWO_SIDED|95.0|-0.16|0.6|||MMRM|||Anxiety Somatic, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.60|-0.16|0.2522
73929602|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.16||0.5026|TWO_SIDED|95.0|-0.43|0.21|||MMRM|||Anxiety Somatic, day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.43|0.5026
73929603|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.149||0.5911|TWO_SIDED|95.0|-0.38|0.22|||MMRM|||Anxiety Somatic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.38|0.5911
73970535|NCT03858634|147481211|SUPERIORITY||LS mean difference|-17.8|STANDARD_ERROR_OF_MEAN|13.31||0.1988|TWO_SIDED|80.0|-35.47|-0.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-0.05|-35.47|0.1988
73970536|NCT03858634|147481211|SUPERIORITY||LS mean difference|-69.2|STANDARD_ERROR_OF_MEAN|56.11||0.3054|TWO_SIDED|80.0|-161.08|22.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||22.72|-161.08|0.3054
73970537|NCT03858634|147481211|SUPERIORITY||LS mean difference|229.4|STANDARD_ERROR_OF_MEAN|377.23||0.5504|TWO_SIDED|80.0|-271.51|730.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||730.22|-271.51|0.5504
73970538|NCT03858634|147481211|SUPERIORITY||LS mean difference|-71.2|STANDARD_ERROR_OF_MEAN|76.27||0.4493|TWO_SIDED|80.0|-214.96|72.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||72.65|-214.96|0.4493
73970539|NCT03858634|147481211|SUPERIORITY||LS mean difference|-40.3|STANDARD_ERROR_OF_MEAN|20.63||0.0665|TWO_SIDED|80.0|-67.74|-12.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-12.85|-67.74|0.0665
74088110|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.07|||<|0.0001|TWO_SIDED|95.0|1.47|2.91|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.91|1.47|<.0001
73970540|NCT03858634|147481211|SUPERIORITY||LS mean difference|-78.7|STANDARD_ERROR_OF_MEAN|54.04||0.2411|TWO_SIDED|80.0|-167.25|9.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||9.75|-167.25|0.2411
73929604|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.122||0.58|TWO_SIDED|95.0|-0.18|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.18|0.5800
73929605|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.129||0.6754|TWO_SIDED|95.0|-0.31|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.31|0.6754
73929606|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.116||0.1006|TWO_SIDED|95.0|-0.04|0.42|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.04|0.1006
73929607|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.12||0.3588|TWO_SIDED|95.0|-0.13|0.35|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.13|0.3588
73929608|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.109||0.5807|TWO_SIDED|95.0|-0.28|0.16|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.28|0.5807
73929609|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.112||0.4241|TWO_SIDED|95.0|-0.13|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.13|0.4241
73929610|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.115||0.7984|TWO_SIDED|95.0|-0.26|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.26|0.7984
73929611|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.122||0.8732|TWO_SIDED|95.0|-0.22|0.26|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.22|0.8732
73929612|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.107||0.8621|TWO_SIDED|95.0|-0.19|0.23|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.19|0.8621
74088111|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0064|TWO_SIDED|95.0|1.18|2.78|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.78|1.18|0.0064
74088112|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.68||||0.018|TWO_SIDED|95.0|1.09|2.58|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.09|0.0180
74088113|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|5.61||||0.0006|TWO_SIDED|95.0|2.09|15.08|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||15.08|2.09|0.0006
74088114|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0034|TWO_SIDED|95.0|1.64|12.13|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||12.13|1.64|0.0034
74088115|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.44|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.22|0.0022
73929613|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.126||0.1087|TWO_SIDED|95.0|-0.45|0.05|||MMRM|||Somatic Symptoms Gastrointestinal, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.45|0.1087
73862809|NCT01264770|147271526|SUPERIORITY_OR_OTHER||Treatment difference|0.14||||0.094|TWO_SIDED|90.0|0.0|0.29|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.29|0.00|0.094
73862810|NCT01264770|147271527|SUPERIORITY_OR_OTHER||Treatment difference|-0.2||||0.043|TWO_SIDED|90.0|-0.36|-0.04|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.04|-0.36|0.043
73862811|NCT01264770|147271527|SUPERIORITY_OR_OTHER||Treatment difference|-0.14||||0.158|TWO_SIDED|90.0|-0.31|0.02|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.02|-0.31|0.158
73862812|NCT01264770|147271527|SUPERIORITY_OR_OTHER||Treatment difference|-0.32||||0.001|TWO_SIDED|90.0|-0.47|-0.16|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.16|-0.47|0.001
73862813|NCT01264770|147271528|SUPERIORITY_OR_OTHER||Treatment difference|-2.77||||0.05|TWO_SIDED|90.0|-5.08|-0.45|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.45|-5.08|0.050
73862814|NCT01264770|147271528|SUPERIORITY_OR_OTHER||Treatment difference|-1.33||||0.36|TWO_SIDED|90.0|-3.73|1.06|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.06|-3.73|0.360
73862815|NCT01264770|147271528|SUPERIORITY_OR_OTHER||Treatment difference|-2.99||||0.032|TWO_SIDED|90.0|-5.29|-0.7|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.70|-5.29|0.032
73862816|NCT01264770|147271529|SUPERIORITY_OR_OTHER||Treatment difference|-1.02||||0.568|TWO_SIDED|90.0|-3.95|1.92|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.92|-3.95|0.568
73862817|NCT01264770|147271529|SUPERIORITY_OR_OTHER||Treatment difference|-1.66||||0.368|TWO_SIDED|90.0|-4.69|1.38|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.38|-4.69|0.368
73862818|NCT01264770|147271529|SUPERIORITY_OR_OTHER||Treatment difference|-2.48||||0.16|TWO_SIDED|90.0|-5.38|0.43|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.43|-5.38|0.160
73862819|NCT01018095|147271533|NON_INFERIORITY_OR_EQUIVALENCE|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at TOC was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.191||0.045|TWO_SIDED|95.0|0.25|1.0|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.||1.00|0.25|.045
73862820|NCT01018095|147271533|NON_INFERIORITY_OR_EQUIVALENCE|It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.|Risk Ratio (RR)|0.46|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.21|0.98||Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test.|Chi-squared|||||0.98|0.21|<0.05
73970541|NCT03858634|147481211|SUPERIORITY||LS mean difference|60.8|STANDARD_ERROR_OF_MEAN|79.3||0.4528|TWO_SIDED|80.0|-44.51|166.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||166.08|-44.51|0.4528
73929614|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.125||0.2153|TWO_SIDED|95.0|-0.41|0.09|||MMRM|||Somatic Symptoms Gastrointestinal, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.41|0.2153
73929615|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.145||0.1422|TWO_SIDED|95.0|-0.51|0.07|||MMRM|||Somatic Symptoms Gastrointestinal, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.51|0.1422
73929616|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.114||0.7211|TWO_SIDED|95.0|-0.19|0.27|||MMRM|||Somatic Symptoms Gastrointestinal, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.19|0.7211
73929617|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.103||0.8224|TWO_SIDED|95.0|-0.18|0.23|||MMRM|||Somatic Symptoms General, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.18|0.8224
73929618|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6362|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Somatic Symptoms General, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6362
73929619|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.123||0.6094|TWO_SIDED|95.0|-0.31|0.18|||MMRM|||Somatic Symptoms General, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.31|0.6094
73929620|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.123||0.0457|TWO_SIDED|95.0|-0.49|0.0|||MMRM|||Somatic Symptoms General, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.49|0.0457
73929621|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5691|TWO_SIDED|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.36|0.5691
73929622|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2942|TWO_SIDED|95.0|-0.4|0.12|||MMRM|||Somatic Symptoms General, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.40|0.2942
73929623|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.136||0.5389|TWO_SIDED|95.0|-0.35|0.19|||MMRM|||Somatic Symptoms General, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.35|0.5389
73929624|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.141||0.4061|TWO_SIDED|95.0|-0.4|0.16|||MMRM|||Somatic Symptoms General, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.40|0.4061
73929625|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.153||0.099|TWO_SIDED|95.0|-0.56|0.05|||MMRM|||Somatic Symptoms General, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.56|0.0990
73970542|NCT03858634|147481211|SUPERIORITY||LS mean difference|-41.4|STANDARD_ERROR_OF_MEAN|75.46||0.6381|TWO_SIDED|80.0|-183.72|100.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||100.85|-183.72|0.6381
73929626|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.138||0.0108|TWO_SIDED|95.0|-0.63|-0.08|||MMRM|||Somatic Symptoms General, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.63|0.0108
73929627|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.0889|TWO_SIDED|95.0|-0.59|0.04|||MMRM|||Somatic Symptoms General, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.59|0.0889
73929628|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.169||0.3721|TWO_SIDED|95.0|-0.18|0.49|||MMRM|||Somatic Symptoms General, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.49|-0.18|0.3721
73929629|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.141||0.5513|TWO_SIDED|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.36|0.5513
73929630|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.067||0.0748|TWO_SIDED|95.0|-0.01|0.26|||MMRM|||Genital Symptoms, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.01|0.0748
73929631|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.087||0.3545|TWO_SIDED|95.0|-0.09|0.25|||MMRM|||Genital Symptoms, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.09|0.3545
73929632|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.094||0.6531|TWO_SIDED|95.0|-0.14|0.23|||MMRM|||Genital Symptoms, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.14|0.6531
73929633|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.115||0.752|TWO_SIDED|95.0|-0.26|0.19|||MMRM|||Genital Symptoms, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.26|0.7520
73929634|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.123||0.8861|TWO_SIDED|95.0|-0.26|0.23|||MMRM|||Genital Symptoms, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.26|0.8861
73929635|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.127||0.328|TWO_SIDED|95.0|-0.38|0.13|||MMRM|||Genital Symptoms, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.38|0.3280
73929636|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.128||0.1123|TWO_SIDED|95.0|-0.46|0.05|||MMRM|||Genital Symptoms, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.46|0.1123
73929637|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.116||0.2541|TWO_SIDED|95.0|-0.36|0.1|||MMRM|||Genital Symptoms, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.36|0.2541
73970543|NCT03858634|147481211|SUPERIORITY||LS mean difference|-31.5|STANDARD_ERROR_OF_MEAN|17.22||0.0837|TWO_SIDED|80.0|-54.44|-8.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-8.62|-54.44|0.0837
74029602|NCT03408873|147613706|OTHER||Mean Difference (Final Values)|-10.7||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.02
74029603|NCT00532883|147613712|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||This is a global test comparing all four treatment arms.|Mixed Models Analysis|||F-test from a longitudinal mixed model (controlling for baseline measurement)testing the hypothesis of no difference in mean percent dense cells between the four treatment groups at Visit 6. The study was originally powered to detect a difference of 20%, but it was stopped early.||||0.93
74029604|NCT02202031|147613723|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.6222|TWO_SIDED|95.0|-0.73|1.21|||ANCOVA|change from baseline, adjusted for baseline value||||1.21|-0.73|0.6222
74029605|NCT02202031|147613724|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.7695|TWO_SIDED|95.0|-0.64|0.47|||ANCOVA|change from baseline, adjusted for baseline value||||0.47|-0.64|0.7695
74029606|NCT02202031|147613725|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.6456|TWO_SIDED|95.0|-0.24|0.39|||ANCOVA|change from baseline value, adjusted for baseline value||||0.39|-0.24|0.6456
74029607|NCT02202031|147613726|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.919|TWO_SIDED|95.0|-0.66|0.6|||ANCOVA|change from baseline, adjusted for baseline value||||0.60|-0.66|0.9190
74088116|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0014|TWO_SIDED|95.0|1.25|2.5|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|1.25|0.0014
74088117|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0003|TWO_SIDED|95.0|1.33|2.64|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.64|1.33|0.0003
73929638|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.143||0.011|TWO_SIDED|95.0|-0.66|-0.09|||MMRM|||Genital Symptoms, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.66|0.0110
73929639|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.772|TWO_SIDED|95.0|-0.36|0.27|||MMRM|||Genital Symptoms, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.36|0.7720
73929640|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6311|TWO_SIDED|95.0|-0.52|0.32|||MMRM|||Genital Symptoms, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.52|0.6311
74088118|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.68||||0.003|TWO_SIDED|95.0|1.19|2.36|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.36|1.19|0.0030
74088119|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0754|TWO_SIDED|95.0|0.96|2.24|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.24|0.96|0.0754
73970544|NCT03858634|147481211|SUPERIORITY||LS mean difference|-74.7|STANDARD_ERROR_OF_MEAN|66.45||0.3428|TWO_SIDED|80.0|-183.53|34.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||34.13|-183.53|0.3428
73970545|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|21.8|STANDARD_ERROR_OF_MEAN|22.93||0.3533|TWO_SIDED|80.0|-8.63|52.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||52.27|-8.63|0.3533
73970546|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-63.9|STANDARD_ERROR_OF_MEAN|56.53||0.3755|TWO_SIDED|80.0|-170.51|42.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||42.66|-170.51|0.3755
74029608|NCT02202031|147613727|SUPERIORITY||Mean Difference (Final Values)|1.16||||0.5358|TWO_SIDED|95.0|-2.51|4.84|||ANCOVA|change from baseline, adjusted for baseline value.||||4.84|-2.51|0.5358
74029609|NCT02202031|147613728|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.4663|TWO_SIDED|95.0|-2.9|6.34|||ANCOVA|change from baseline, adjusted for baseline value||||6.34|-2.90|0.4663
74029610|NCT02202031|147613729|SUPERIORITY||Mean Difference (Final Values)|2.17||||0.3134|TWO_SIDED|95.0|-2.05|6.38|||ANCOVA|change from baseline, adjusted for baseline value||||6.38|-2.05|0.3134
74029611|NCT02202031|147613730|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.5146|TWO_SIDED|95.0|-7.05|3.53|||ANCOVA|change from baseline, adjusted for baseline value||||3.53|-7.05|0.5146
74029612|NCT02202031|147613731|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3611|TWO_SIDED|95.0|-0.44|0.16|||ANCOVA|change from baseline, adjusted for baseline value||||0.16|-0.44|0.3611
74088120|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0253|TWO_SIDED|95.0|1.06|2.44|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.06|0.0253
73929641|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.207||0.6877|TWO_SIDED|95.0|-0.5|0.33|||MMRM|||Genital Symptoms, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.50|0.6877
73929642|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.186||0.2465|TWO_SIDED|95.0|-0.15|0.58|||MMRM|||Genital Symptoms, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|-0.15|0.2465
73929643|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.101||0.1279|TWO_SIDED|95.0|-0.36|0.05|||MMRM|||Hypochondriasis, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.36|0.1279
73929644|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.093||0.3946|TWO_SIDED|95.0|-0.26|0.1|||MMRM|||Hypochondriasis, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.26|0.3946
73929645|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.095||0.6694|TWO_SIDED|95.0|-0.23|0.15|||MMRM|||Hypochondriasis, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.23|0.6694
73929646|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.1113|TWO_SIDED|95.0|-0.36|0.04|||MMRM|||Hypochondriasis, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.36|0.1113
73929647|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.089||0.5811|TWO_SIDED|95.0|-0.13|0.23|||MMRM|||Hypochondriasis, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.13|0.5811
73929648|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.106||0.6794|TWO_SIDED|95.0|-0.25|0.17|||MMRM|||Hypochondriasis, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.25|0.6794
73929649|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.099||0.6031|TWO_SIDED|95.0|-0.14|0.25|||MMRM|||Hypochondriasis, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.14|0.6031
73970547|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-37.6|STANDARD_ERROR_OF_MEAN|15.6||0.0268|TWO_SIDED|80.0|-58.39|-16.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-16.87|-58.39|0.0268
73970548|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-79.5|STANDARD_ERROR_OF_MEAN|43.79||0.1672|TWO_SIDED|80.0|-151.2|-7.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-7.75|-151.20|0.1672
73970549|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|43.7|STANDARD_ERROR_OF_MEAN|45.81||0.3518|TWO_SIDED|80.0|-17.09|104.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||104.55|-17.09|0.3518
73970550|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-68.7|STANDARD_ERROR_OF_MEAN|49.22||0.2974|TWO_SIDED|80.0|-161.52|24.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||24.09|-161.52|0.2974
73970551|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-38.1|STANDARD_ERROR_OF_MEAN|18.6||0.0555|TWO_SIDED|80.0|-62.83|-13.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.33|-62.83|0.0555
73970552|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-78.3|STANDARD_ERROR_OF_MEAN|56.72||0.2614|TWO_SIDED|80.0|-171.17|14.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||14.62|-171.17|0.2614
73970553|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|31.7|STANDARD_ERROR_OF_MEAN|37.89||0.4134|TWO_SIDED|80.0|-18.62|81.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||81.98|-18.62|0.4134
74029613|NCT02202031|147613732|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.6722|TWO_SIDED|95.0|-2.43|1.57|||ANCOVA|change from baseline, adjusted for baseline value||||1.57|-2.43|0.6722
73862821|NCT01018095|147271534|NON_INFERIORITY_OR_EQUIVALENCE|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at 3 months was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.46|STANDARD_ERROR_OF_MEAN|0.196|=|0.03|TWO_SIDED|95.0|0.21|0.98|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.||0.98|.21|=0.03
73862822|NCT05714943|147271603|SUPERIORITY|||||||0.99|||||||Regression, Linear|||||||.99
73862823|NCT05714943|147271604|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
73862824|NCT05714943|147271605|SUPERIORITY|||||||0.09|||||||Regression, Linear|||||||.09
73862825|NCT05714943|147271606|SUPERIORITY|||||||0.57|||||||Regression, Linear|||||||.57
73862826|NCT05714943|147271607|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||.32
73862827|NCT05714943|147271608|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
74088121|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0098|TWO_SIDED|95.0|1.3|6.83|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.83|1.30|0.0098
74088122|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.72||||0.223|TWO_SIDED|95.0|0.72|4.13|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.13|0.72|0.2230
73929650|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.099||0.6673|TWO_SIDED|95.0|-0.24|0.15|||MMRM|||Hypochondriasis, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.24|0.6673
73929651|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.102||0.6472|TWO_SIDED|95.0|-0.25|0.16|||MMRM|||Hypochondriasis, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.25|0.6472
73970554|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-69.6|STANDARD_ERROR_OF_MEAN|44.99||0.262|TWO_SIDED|80.0|-154.44|15.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||15.24|-154.44|0.2620
73970555|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|16.7||0.0269|TWO_SIDED|80.0|-62.46|-18.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-18.02|-62.46|0.0269
73862828|NCT05714943|147271609|SUPERIORITY|||||||0.97|||||||Regression, Linear|||||||.97
73862829|NCT05714943|147271610|SUPERIORITY|||||||0.21|||||||Regression, Linear|||||||.21
73862830|NCT05714943|147271611|SUPERIORITY|||||||0.27|||||||Regression, Linear|||||||.27
73862831|NCT05714943|147271612|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
73862832|NCT05714943|147271613|SUPERIORITY|||||||0.86|||||||Regression, Linear|||||||.86
73970556|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-81.2|STANDARD_ERROR_OF_MEAN|45.32||0.1709|TWO_SIDED|80.0|-155.46|-7.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-7.02|-155.46|0.1709
73970557|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|42.9|STANDARD_ERROR_OF_MEAN|12.98||0.0042|TWO_SIDED|80.0|25.61|60.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||60.22|25.61|0.0042
73862833|NCT05714943|147271614|SUPERIORITY|||||||0.61|||||||Regression, Linear|||||||.61
73862834|NCT05714943|147271615|SUPERIORITY|||||||0.02|||||||Regression, Linear|||||||.02
73862835|NCT05714943|147271616|SUPERIORITY|||||||0.08|||||||Regression, Linear|||||||.08
73862836|NCT05714943|147271617|SUPERIORITY|||||||0.08|||||||Regression, Linear|||||||.08
73862837|NCT05714943|147271618|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||.06
73862838|NCT05714943|147271619|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
73862839|NCT05714943|147271620|SUPERIORITY|||||||0.88|||||||Regression, Linear|||||||.88
73862840|NCT05714943|147271621|SUPERIORITY|||||||0.94|||||||Regression, Linear|||||||.94
73862841|NCT04075409|147271631|OTHER||LS means ratio|1.426|||||TWO_SIDED|90.0|1.112|1.83|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% Confidence Intervals (CIs) were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.830|1.112|
73862842|NCT04075409|147271631|OTHER||LS means ratio|1.234|||||TWO_SIDED|90.0|0.9619|1.584|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.584|0.9619|
73970558|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-53.2|STANDARD_ERROR_OF_MEAN|47.22||0.3772|TWO_SIDED|80.0|-142.19|35.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||35.88|-142.19|0.3772
73970559|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-28.3|STANDARD_ERROR_OF_MEAN|15.54||0.0857|TWO_SIDED|80.0|-49.06|-7.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-7.63|-49.06|0.0857
73929652|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.119||0.8654|TWO_SIDED|95.0|-0.26|0.22|||MMRM|||Hypochondriasis, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.26|0.8654
73929653|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.14||0.2101|TWO_SIDED|95.0|-0.48|0.11|||MMRM|||Hypochondriasis, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.48|0.2101
73929654|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.126||0.7128|TWO_SIDED|95.0|-0.3|0.21|||MMRM|||Hypochondriasis, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.30|0.7128
73929655|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.09||0.3297|TWO_SIDED|95.0|-0.27|0.09|||MMRM|||Hypochondriasis, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.27|0.3297
73929656|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.069||0.4493|TWO_SIDED|95.0|-0.08|0.19|||MMRM|||Loss of weight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.08|0.4493
73929657|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.081||0.0717|TWO_SIDED|95.0|-0.01|0.31|||MMRM|||Loss of weight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.01|0.0717
73929658|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.066||0.1054|TWO_SIDED|95.0|-0.02|0.24|||MMRM|||Loss of Weight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.02|0.1054
73929659|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.088||0.0408|TWO_SIDED|95.0|0.01|0.36|||MMRM|||Loss of Weight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|0.01|0.0408
73929660|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.088||0.0233|TWO_SIDED|95.0|0.03|0.38|||MMRM|||Loss of Weight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|0.03|0.0233
73929661|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.088||0.361|TWO_SIDED|95.0|-0.09|0.26|||MMRM|||Loss of Weight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.09|0.3610
73929662|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2358|TWO_SIDED|95.0|-0.08|0.32|||MMRM|||Loss of Weight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.08|0.2358
73929663|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.085||0.9492|TWO_SIDED|95.0|-0.16|0.17|||MMRM|||Loss of Weight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.16|0.9492
73970560|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-77.3|STANDARD_ERROR_OF_MEAN|26.34||0.0607|TWO_SIDED|80.0|-120.48|-34.2||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-34.20|-120.48|0.0607
73862843|NCT04075409|147271631|OTHER||LS means ratio|1.156|||||TWO_SIDED|90.0|0.9008|1.483|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.483|0.9008|
73929664|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.102||0.4352|TWO_SIDED|95.0|-0.28|0.12|||MMRM|||Loss of Weight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.28|0.4352
73929665|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.125||0.1176|TWO_SIDED|95.0|-0.05|0.44|||MMRM|||Loss of Weight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.05|0.1176
73929666|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.174||0.7812|TWO_SIDED|95.0|-0.3|0.4|||MMRM|||Loss of Weight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.30|0.7812
73929667|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.182||0.5085|TWO_SIDED|95.0|-0.48|0.24|||MMRM|||Loss of Weight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.48|0.5085
73929668|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.156||0.8274|TWO_SIDED|95.0|-0.28|0.34|||MMRM|||Loss of Weight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.28|0.8274
73929669|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.3675|TWO_SIDED|95.0|-0.13|0.05|||MMRM|||Insight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.13|0.3675
73929670|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.1818|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||Insight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.15|0.1818
73929671|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.045||0.0826|TWO_SIDED|95.0|-0.17|0.01|||MMRM|||Insight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.17|0.0826
73929672|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6436|TWO_SIDED|95.0|-0.11|0.07|||MMRM|||Insight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.11|0.6436
73929673|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.1827|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||Insight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.15|0.1827
73862844|NCT04075409|147271632|OTHER||LS means ratio|2.122|||||TWO_SIDED|90.0|1.706|2.638|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.638|1.706|
73970561|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|88.8|STANDARD_ERROR_OF_MEAN|124.79||0.4862|TWO_SIDED|80.0|-77.57|255.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||255.22|-77.57|0.4862
73970562|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-53.2|STANDARD_ERROR_OF_MEAN|49.73||0.3968|TWO_SIDED|80.0|-146.96|40.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||40.58|-146.96|0.3968
73929674|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.045||0.9859|TWO_SIDED|95.0|-0.09|0.09|||MMRM|||Insight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.09|0.9859
73929675|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6672|TWO_SIDED|95.0|-0.07|0.11|||MMRM|||Insight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.07|0.6672
73929676|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.046||0.2031|TWO_SIDED|95.0|-0.03|0.15|||MMRM|||Insight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.03|0.2031
73929677|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6664|TWO_SIDED|95.0|-0.07|0.11|||MMRM|||Insight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.07|0.6664
73929678|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.3417|TWO_SIDED|95.0|-0.13|0.05|||MMRM|||Insight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.13|0.3417
73929679|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.6622|TWO_SIDED|95.0|-0.12|0.08|||MMRM|||Insight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.12|0.6622
73970563|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|16.57||0.1624|TWO_SIDED|80.0|-46.31|-2.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-2.11|-46.31|0.1624
73970564|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-76.8|STANDARD_ERROR_OF_MEAN|37.75||0.1349|TWO_SIDED|80.0|-138.58|-14.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-14.93|-138.58|0.1349
73970565|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|45.5|STANDARD_ERROR_OF_MEAN|21.81||0.0525|TWO_SIDED|80.0|16.38|74.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||74.56|16.38|0.0525
73862845|NCT04075409|147271632|OTHER||LS means ratio|1.289|||||TWO_SIDED|90.0|1.037|1.603|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.603|1.037|
73970566|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-76.6|STANDARD_ERROR_OF_MEAN|50.98||0.2719|TWO_SIDED|80.0|-172.71|19.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||19.55|-172.71|0.2719
73970567|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-30.7|STANDARD_ERROR_OF_MEAN|17.39||0.0957|TWO_SIDED|80.0|-53.86|-7.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-7.49|-53.86|0.0957
73970568|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-79.8|STANDARD_ERROR_OF_MEAN|32.98||0.0942|TWO_SIDED|80.0|-133.83|-25.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-25.78|-133.83|0.0942
73970569|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|34.6|STANDARD_ERROR_OF_MEAN|23.6||0.1606|TWO_SIDED|80.0|3.16|66.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||66.09|3.16|0.1606
73970570|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-77.0|STANDARD_ERROR_OF_MEAN|42.2||0.2096|TWO_SIDED|80.0|-156.58|2.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||2.58|-156.58|0.2096
73970571|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-29.3|STANDARD_ERROR_OF_MEAN|18.32||0.1279|TWO_SIDED|80.0|-53.74|-4.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-4.89|-53.74|0.1279
73970572|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-75.0|STANDARD_ERROR_OF_MEAN|23.17||0.0479|TWO_SIDED|80.0|-112.96|-37.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-37.08|-112.96|0.0479
73970573|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|32.8|STANDARD_ERROR_OF_MEAN|22.91||0.17|TWO_SIDED|80.0|2.28|63.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||63.37|2.28|0.1700
73970574|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-80.1|STANDARD_ERROR_OF_MEAN|29.67||0.1142|TWO_SIDED|80.0|-136.03|-24.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-24.15|-136.03|0.1142
74088123|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0201|TWO_SIDED|95.0|1.07|2.12|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.12|1.07|0.0201
74088124|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0021|TWO_SIDED|95.0|1.22|2.44|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.22|0.0021
74088125|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0022
74088126|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0004|TWO_SIDED|95.0|1.32|2.64|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.64|1.32|0.0004
74088127|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.32||||0.2031|TWO_SIDED|95.0|0.86|2.01|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.01|0.86|0.2031
74088128|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0867|TWO_SIDED|95.0|0.95|2.18|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|0.95|0.0867
73929680|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.051||0.9087|TWO_SIDED|95.0|-0.11|0.09|||MMRM|||Insight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.11|0.9087
73929681|NCT02942017|147389128|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.046||0.8263|TWO_SIDED|95.0|-0.08|0.1|||MMRM|||Insight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.08|0.8263
73929682|NCT02942017|147389129|SUPERIORITY||LS mean difference|-4.86|STANDARD_ERROR_OF_MEAN|1.612||0.0033|TWO_SIDED|95.0|-8.06|-1.66|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.66|-8.06|0.0033
73970575|NCT03858634|147481211|SUPERIORITY||LS Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|20.82||0.398|TWO_SIDED|80.0|-45.8|9.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||9.71|-45.80|0.3980
74088129|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1746|TWO_SIDED|95.0|0.77|4.22|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.22|0.77|0.1746
73970576|NCT03858634|147481213|SUPERIORITY||LS mean difference|-13.2|STANDARD_ERROR_OF_MEAN|17.11||0.4979|TWO_SIDED|80.0|-41.17|14.86||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||14.86|-41.17|0.4979
73970577|NCT03858634|147481213|SUPERIORITY||LS mean difference|21.7|STANDARD_ERROR_OF_MEAN|12.88||0.1079|TWO_SIDED|80.0|4.63|38.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||38.83|4.63|0.1079
73970578|NCT03858634|147481213|SUPERIORITY||LS mean difference|-35.6|STANDARD_ERROR_OF_MEAN|41.7||0.4837|TWO_SIDED|80.0|-114.19|43.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||43.07|-114.19|0.4837
73970579|NCT03858634|147481213|SUPERIORITY||LS mean difference|-10.5|STANDARD_ERROR_OF_MEAN|4.14||0.0208|TWO_SIDED|80.0|-15.99|-4.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-4.98|-15.99|0.0208
73970580|NCT03858634|147481213|SUPERIORITY||LS mean difference|-16.2|STANDARD_ERROR_OF_MEAN|23.54||0.5413|TWO_SIDED|80.0|-54.74|22.38||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||22.38|-54.74|0.5413
73970581|NCT03858634|147481213|SUPERIORITY||LS mean difference|17.5|STANDARD_ERROR_OF_MEAN|12.22||0.1683|TWO_SIDED|80.0|1.28|33.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||33.74|1.28|0.1683
73862846|NCT04075409|147271632|OTHER||LS means ratio|1.646|||||TWO_SIDED|90.0|1.323|2.046|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.046|1.323|
73862847|NCT04075409|147271633|OTHER||LS means ratio|2.124|||||TWO_SIDED|90.0|1.709|2.639|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.639|1.709|
73862848|NCT04075409|147271633|OTHER||LS means ratio|1.291|||||TWO_SIDED|90.0|1.039|1.604|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.604|1.039|
73862849|NCT04075409|147271633|OTHER||LS means ratio|1.645|||||TWO_SIDED|90.0|1.324|2.044|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.044|1.324|
73929683|NCT02942017|147389129|SUPERIORITY||LS mean difference|-3.56|STANDARD_ERROR_OF_MEAN|2.154||0.1017|TWO_SIDED|95.0|-7.84|0.72|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.72|-7.84|0.1017
73929684|NCT02942017|147389129|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|1.884||0.9845|TWO_SIDED|95.0|-3.72|3.79|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.79|-3.72|0.9845
73929685|NCT02942017|147389130|SUPERIORITY||Odds Ratio (OR)|5.0||||0.0005|TWO_SIDED|95.0|2.0|12.5|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||12.5|2.0|0.0005
73929686|NCT02942017|147389130|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0478|TWO_SIDED|95.0|1.0|8.4|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||8.4|1.0|0.0478
73929687|NCT02942017|147389130|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4399|TWO_SIDED|95.0|0.5|4.6|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||4.6|0.5|0.4399
73862850|NCT04075409|147271636|OTHER||LS means ratio|1.089|||||TWO_SIDED|90.0|0.8859|1.339|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.339|0.8859|
73862851|NCT04075409|147271636|OTHER||LS means ratio|1.044|||||TWO_SIDED|90.0|0.8489|1.283|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.283|0.8489|
73862852|NCT04075409|147271636|OTHER||LS means ratio|1.044|||||TWO_SIDED|90.0|0.8489|1.283|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.283|0.8489|
73929688|NCT02942017|147389131|SUPERIORITY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.041||0.2636|TWO_SIDED|95.0|-3.24|0.9|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.90|-3.24|0.2636
73862853|NCT04075409|147271637|OTHER||LS means ratio|1.344|||||TWO_SIDED|90.0|1.092|1.653|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.653|1.092|
73862854|NCT04075409|147271637|OTHER||LS means ratio|0.9991|||||TWO_SIDED|90.0|0.812|1.229|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.229|0.8120|
73862855|NCT04075409|147271637|OTHER||LS means ratio|1.345|||||TWO_SIDED|90.0|1.093|1.655|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.655|1.093|
73862856|NCT01595581|147271655|OTHER|Mann-Whitney U test for continuous variables and Fisher exact test for categorical variables|Mean Difference (Net)|2.9|STANDARD_DEVIATION|1.5||0.35|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 6 weeks post operative."||||0.35
73862857|NCT01595581|147271655|OTHER||Mean Difference (Net)|2.17|STANDARD_DEVIATION|2.0||0.48|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 12 weeks post operative."||||0.48
73929689|NCT02942017|147389131|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|1.103||0.4897|TWO_SIDED|95.0|-2.96|1.43|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.43|-2.96|0.4897
73929690|NCT02942017|147389131|SUPERIORITY||LS Mean Difference|-1.86|STANDARD_ERROR_OF_MEAN|1.227||0.1341|TWO_SIDED|95.0|-4.3|0.59|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.59|-4.30|0.1341
73929691|NCT02942017|147389131|SUPERIORITY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|1.408||0.1691|TWO_SIDED|95.0|-4.76|0.85|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.85|-4.76|0.1691
73929692|NCT02942017|147389131|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|1.149||0.7852|TWO_SIDED|95.0|-2.6|1.97|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.97|-2.60|0.7852
73929693|NCT04399161|147389134|SUPERIORITY|||||||0.123|||||||ANOVA|||Comparison among Children||||0.123
73929694|NCT04399161|147389134|SUPERIORITY|||||||0.314|||||||ANOVA|||Comparison among Elderly||||0.314
73929695|NCT00457197|147389135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709|TWO_SIDED||||||ANCOVA|||Baseline drinks/day used as covariate.||||0.4709
73929696|NCT00457197|147389136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1272|TWO_SIDED||||||ANCOVA|||Baseline percent heavy drinking days included as covariate.||||0.1272
74088130|NCT02709486|147729978|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1039|TWO_SIDED|95.0|0.87|4.57|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.57|0.87|0.1039
73929697|NCT00457197|147389137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9642|TWO_SIDED||||||ANCOVA|||Baseline GGT used as covariate.||||0.9642
73929698|NCT00457197|147389138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7222|TWO_SIDED||||||ANCOVA|||Baseline AST used as covariate.||||0.7222
73970582|NCT03858634|147481213|SUPERIORITY||LS mean difference|-58.8|STANDARD_ERROR_OF_MEAN|54.45||0.3933|TWO_SIDED|80.0|-161.43|43.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||43.89|-161.43|0.3933
73862858|NCT01595581|147271655|OTHER||Mean Difference (Net)|1.08|STANDARD_DEVIATION|15.0||0.74|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 24 weeks post operative."||||0.74
73862859|NCT02739321|147271675|NON_INFERIORITY|Hypothesized benchmark of 30%|Risk Difference (RD)|25.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
73862860|NCT02739321|147271676|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||.001
73929699|NCT00457197|147389139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1412|TWO_SIDED||||||ANCOVA|||Baseline ALT used as covariate.||||0.1412
73929700|NCT00457197|147389140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7071|TWO_SIDED||||||ANCOVA|||Baseline HRSD used as covariate.||||0.7071
73929701|NCT00457197|147389141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2569|TWO_SIDED||||||ANCOVA|||Baseline IDS-SR used as a covariate.||||0.2569
73929702|NCT00457197|147389142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8814|TWO_SIDED||||||ANCOVA|||Baseline YMRS used as a covariate.||||0.8814
73929703|NCT00457197|147389143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2473|TWO_SIDED||||||ANCOVA|||Baseline PACS used as a covariate.||||0.2473
73929704|NCT02114879|147389209|SUPERIORITY|||||||0.007||||||The p-value refers to the time by group interaction. The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Marginal Model|||This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).||||0.007
73929705|NCT02114879|147389210|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
73929706|NCT02114879|147389211|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
73929707|NCT02114879|147389212|SUPERIORITY|||||||0.96||||||The p-value refers to the time by group interaction. The statistical significance in this test was p\<0.05.|Mixed Models Analysis|||This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).||||0.96
73929708|NCT02114879|147389213|SUPERIORITY|||||||0.37||||||The p-value is calculated from a 2x2 Contingency Table consisting of rows that represent Discharged Home Vs Discharged to Institution and columns that represent the EMR and SOC groups.|Chi-squared|||||||0.37
73929709|NCT02114879|147389214|SUPERIORITY|||||||0.85||||||The p-value is calculated from a 2x2 Contingency Table consisting of rows that represent Yes/No Rehospitalization and columns that represent the EMR and SOC groups.|Chi-squared|||||||0.85
73929710|NCT04538664|147389225|SUPERIORITY||Hazard Ratio (HR)|0.395|||<|0.0001|TWO_SIDED|95.0|0.296|0.528|||Log Rank|||||0.528|0.296|<0.0001
73929711|NCT04552587|147389251|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||We compared change from baseline to follow up in our single group of caregivers.||||0.23
73929712|NCT03400033|147389286|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95 percent (%) confidence interval (CI) for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.|Least square (LS) mean difference|-0.05|||||TWO_SIDED|95.0|-0.21|0.1||||||||0.10|-0.21|
73929713|NCT03400033|147389287|SUPERIORITY||LS mean difference|-8.12||||0.3354|TWO_SIDED|95.0|-45.66|29.41|||ANCOVA|||||29.41|-45.66|0.3354
73929714|NCT03400033|147389288|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|-0.14|||||TWO_SIDED|95.0|-0.37|0.1||||||||0.10|-0.37|
74088131|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0003|TWO_SIDED|95.0|1.33|2.68|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.68|1.33|0.0003
73929715|NCT03400033|147389289|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was above the non-inferiority margin of - 15%.|Median Difference (Final Values)|11.18||||0.0034|TWO_SIDED|95.0|2.83|19.56|||Van Elteren's test||Hodges-Lehmann Estimate of Treatment Difference has been reported.|||19.56|2.83|0.0034
73929716|NCT03400033|147389290|OTHER||Difference in response rate|0.1645||||0.0007|TWO_SIDED|95.0|0.06|0.27|||Cochran-Mantel-Haenszel|||||0.27|0.06|0.0007
73970583|NCT03858634|147481213|SUPERIORITY||LS mean difference|-5.7|STANDARD_ERROR_OF_MEAN|6.25||0.3705|TWO_SIDED|80.0|-14.06|2.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||2.58|-14.06|0.3705
73970584|NCT03858634|147481213|SUPERIORITY||LS mean difference|-23.0|STANDARD_ERROR_OF_MEAN|35.63||0.5644|TWO_SIDED|80.0|-81.36|35.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||35.34|-81.36|0.5644
73862861|NCT02739321|147271677|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
73929717|NCT03400033|147389291|OTHER||Hazard Ratio (HR)|1.06||||0.5308|TWO_SIDED|95.0|0.26|4.22|||Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model adjusted for treatment group and region.|||4.22|0.26|0.5308
73929718|NCT03400033|147389292|SUPERIORITY||LS mean difference|-3.73||||0.083|TWO_SIDED|95.0|-9.03|1.56|||MMRM||SBP|||1.56|-9.03|0.083
73929719|NCT03400033|147389292|SUPERIORITY||LS mean difference|-2.23||||0.057|TWO_SIDED|95.0|-4.99|0.54|||MMRM||DBP|||0.54|-4.99|0.057
73929720|NCT03400033|147389292|SUPERIORITY||LS mean difference|-2.6||||0.059|TWO_SIDED|95.0|-5.86|0.67|||MMRM||MAP|||0.67|-5.86|0.059
73929721|NCT03400033|147389293|SUPERIORITY||Mean Difference (Net)|-0.5||||0.407|TWO_SIDED|95.0|-4.73|3.72|||ANCOVA||SBP|||3.72|-4.73|0.407
73929722|NCT03400033|147389293|SUPERIORITY||Mean Difference (Net)|-1.05||||0.179|TWO_SIDED|95.0|-3.29|1.19|||ANCOVA||DBP|||1.19|-3.29|0.179
73929723|NCT03400033|147389293|SUPERIORITY||Mean Difference (Net)|-0.86||||0.261|TWO_SIDED|95.0|-3.5|1.78|||ANCOVA||MAP|||1.78|-3.50|0.261
73929724|NCT03400033|147389294|OTHER||Ratio of exacerbation rate|0.7||||0.0093|TWO_SIDED|95.0|0.52|0.94|||Negative binomial model|||||0.94|0.52|0.0093
73929725|NCT03400033|147389296|SUPERIORITY||LS mean difference|-0.15||||0.0323|TWO_SIDED|95.0|-0.32|0.01|||MMRM||Week 8|||0.01|-0.32|0.0323
73929726|NCT03400033|147389296|SUPERIORITY||LS mean difference|-0.12||||0.0921|TWO_SIDED|95.0|-0.29|0.06|||MMRM||Week 12|||0.06|-0.29|0.0921
73929727|NCT03400033|147389296|SUPERIORITY||LS mean difference|-0.11||||0.1291|TWO_SIDED|95.0|-0.29|0.08|||MMRM||Week 28|||0.08|-0.29|0.1291
73862862|NCT02739321|147271678|SUPERIORITY||Median Difference (Final Values)|4.09||||0.268|TWO_SIDED||||||Mixed Models Analysis|||||||.268
73929728|NCT03400033|147389296|SUPERIORITY||LS mean difference|-0.15||||0.0859|TWO_SIDED|95.0|-0.36|0.06|||MMRM||Week 52|||0.06|-0.36|0.0859
73929729|NCT02741115|147389309|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.377||0.092|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|ANCOVA fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation used.||It was estimated that a sample size of 198 participants per group would provide 90% power to detect a mean treatment group difference in change from baseline to Week 26 in maximal VO2 scores of 10% (ie, an improvement of 2.8 mL/kg/min in the udenafil group compared to 0 in the control group, assuming a Type I error of 0.05 and standard deviation of 7.235). A difference of 2.8, equivalent to a 10% increase from a baseline of 28 mL/kg/min, represents approximately 0.4 standard deviations.||||0.092
73970585|NCT03858634|147481213|SUPERIORITY||LS mean difference|6.6|STANDARD_ERROR_OF_MEAN|13.82||0.6384|TWO_SIDED|80.0|-11.75|24.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||24.94|-11.75|0.6384
73929730|NCT02741115|147389310|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.014||0.024|TWO_SIDED|||||LS mean was the estimated treatment difference from the analytical model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2.||||||0.024
74088132|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0286|TWO_SIDED|95.0|1.04|2.1|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.10|1.04|0.0286
74088133|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1031|TWO_SIDED|95.0|0.93|2.27|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.27|0.93|0.1031
73862863|NCT02739321|147271679|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.058|TWO_SIDED||||||Mixed Models Analysis|||||||.058
73929731|NCT02741115|147389311|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.591||0.591|TWO_SIDED||||||ANCOVA|||||||0.591
73929732|NCT02741115|147389312|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.094||0.169|TWO_SIDED||||||ANCOVA|||||||0.169
73929733|NCT02741115|147389313|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Median Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|0.308||0.012|TWO_SIDED|||||LS mean was the estimated treatment mean difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.012
73929734|NCT02741115|147389314|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.46||0.029|TWO_SIDED|||||LS mean was the estimated treatment difference in the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.029
73929735|NCT02741115|147389315|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.321||0.011|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.011
73929736|NCT02741115|147389316|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.903||0.696|TWO_SIDED||||||ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline VO2. LOCF imputation.||||||0.696
73929737|NCT02741115|147389317|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.319||0.915|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.915
73929738|NCT02741115|147389318|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|1.363||0.891|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||LS mean differences between treatment groups were analyzed.||||0.891
73929739|NCT02741115|147389319|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.1||0.691|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline physical functioning (child reported)||||||0.691
73929740|NCT02741115|147389320|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.544||0.985|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline physical functioning (parent reported).||||||0.985
73929741|NCT02741115|147389321|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.039||0.273|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline psychosocial health summary score (child reported).||||||0.273
73929742|NCT02741115|147389322|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|1.327||0.966|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline psychosocial health summary score (parent reported).||||||0.966
73929743|NCT02741115|147389323|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|1.011||0.706|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (Treatment II).||||||0.706
73929744|NCT02741115|147389324|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|1.707||0.382|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (perceived physical appearance)||||||0.382
73929745|NCT02741115|147389325|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|1.611||0.236|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (treatment anxiety).||||||0.236
73929746|NCT02741115|147389326|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|1.622||0.543|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (cognitive problems).||||||0.543
73929747|NCT02741115|147389327|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|1.78||0.352|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (communication problems).||||||0.352
73929748|NCT02741115|147389328|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|5.684||0.533|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors of ventricular morphology and treatment group with a continuous covariate of Baseline total score (age 8-12, child reported).||||||0.533
73929749|NCT02741115|147389329|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|4.057||0.654|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline total score (age 8-12, parent reported).||||||0.654
73929750|NCT02741115|147389330|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.069||0.963|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline total score (ages 13-18, child reported)||||||0.963
73970586|NCT03858634|147481213|SUPERIORITY||LS mean difference|-58.6|STANDARD_ERROR_OF_MEAN|58.62||0.4229|TWO_SIDED|80.0|-169.13|51.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||51.95|-169.13|0.4229
73970587|NCT03858634|147481213|SUPERIORITY||LS mean difference|-16.3|STANDARD_ERROR_OF_MEAN|11.38||0.1688|TWO_SIDED|80.0|-31.47|-1.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-1.18|-31.47|0.1688
73970588|NCT03858634|147481213|SUPERIORITY||LS mean difference|-59.6|STANDARD_ERROR_OF_MEAN|28.11||0.1243|TWO_SIDED|80.0|-105.59|-13.53||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-13.53|-105.59|0.1243
73970589|NCT03858634|147481213|SUPERIORITY||LS mean difference|6.9|STANDARD_ERROR_OF_MEAN|16.79||0.6841|TWO_SIDED|80.0|-15.35|29.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||29.22|-15.35|0.6841
73970590|NCT03858634|147481213|SUPERIORITY||LS mean difference|-53.4|STANDARD_ERROR_OF_MEAN|49.83||0.3963|TWO_SIDED|80.0|-147.31|40.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||40.59|-147.31|0.3963
73970591|NCT03858634|147481213|SUPERIORITY||LS mean difference|-24.1|STANDARD_ERROR_OF_MEAN|11.85||0.0571|TWO_SIDED|80.0|-39.85|-8.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-8.32|-39.85|0.0571
73970592|NCT03858634|147481213|SUPERIORITY||LS mean difference|-35.3|STANDARD_ERROR_OF_MEAN|40.32||0.4457|TWO_SIDED|80.0|-101.32|30.73||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||30.73|-101.32|0.4457
74088134|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2033|TWO_SIDED|95.0|0.85|2.1|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.10|0.85|0.2033
73970593|NCT03858634|147481213|SUPERIORITY||LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|17.99||0.8075|TWO_SIDED|80.0|-19.44|28.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||28.32|-19.44|0.8075
74088135|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0064|TWO_SIDED|95.0|1.34|5.86|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||5.86|1.34|0.0064
73862864|NCT02739321|147271680|SUPERIORITY||Mean Difference (Final Values)|2.82||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
73862865|NCT02739321|147271681|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|||||||.232
73862866|NCT02739321|147271682|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.100
73929751|NCT02741115|147389331|SUPERIORITY|LS mean differences between treatment group were analyzed.|Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|1.171||0.246|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors of ventricular morphology and treatment group with a continuous covariate of Baseline total score (ages 13-18, parent reported).||||||0.246
73929752|NCT06425458|147389336|OTHER|||||||0.0011||||||Threshold for statistical significance: P \<= 0.05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Self-Esteem (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.0011
73970594|NCT03858634|147481213|SUPERIORITY||LS mean difference|-57.7|STANDARD_ERROR_OF_MEAN|55.75||0.4093|TWO_SIDED|80.0|-162.84|47.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||47.40|-162.84|0.4093
73970595|NCT03858634|147481213|SUPERIORITY||LS mean difference|-27.6|STANDARD_ERROR_OF_MEAN|13.4||0.0543|TWO_SIDED|80.0|-45.42|-9.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-9.76|-45.42|0.0543
73970596|NCT03858634|147481213|SUPERIORITY||LS mean difference|-31.0|STANDARD_ERROR_OF_MEAN|37.75||0.4711|TWO_SIDED|80.0|-92.88|30.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||30.78|-92.88|0.4711
73970597|NCT03858634|147481213|SUPERIORITY||LS mean difference|13.0|STANDARD_ERROR_OF_MEAN|14.89||0.3925|TWO_SIDED|80.0|-6.74|32.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||32.79|-6.74|0.3925
73970598|NCT03858634|147481213|SUPERIORITY||LS mean difference|-48.7|STANDARD_ERROR_OF_MEAN|61.24||0.5095|TWO_SIDED|80.0|-164.22|66.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||66.72|-164.22|0.5095
73970599|NCT03858634|147481213|SUPERIORITY||LS mean difference|-33.8|STANDARD_ERROR_OF_MEAN|13.22||0.0199|TWO_SIDED|80.0|-51.35|-16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-16.18|-51.35|0.0199
73970600|NCT03858634|147481213|SUPERIORITY||LS mean difference|-42.8|STANDARD_ERROR_OF_MEAN|34.48||0.3029|TWO_SIDED|80.0|-99.26|13.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||13.69|-99.26|0.3029
74088136|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.44||||0.3706|TWO_SIDED|95.0|0.65|3.23|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|0.65|0.3706
74088137|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.39||||0.2121|TWO_SIDED|95.0|0.61|9.41|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.41|0.61|0.2121
73970601|NCT03858634|147481213|SUPERIORITY||LS mean difference|10.9|STANDARD_ERROR_OF_MEAN|12.97||0.4094|TWO_SIDED|80.0|-6.28|28.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||28.16|-6.28|0.4094
73970602|NCT03858634|147481213|SUPERIORITY||LS mean difference|-49.8|STANDARD_ERROR_OF_MEAN|58.25||0.4828|TWO_SIDED|80.0|-159.63|60.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||60.05|-159.63|0.4828
73970603|NCT03858634|147481213|SUPERIORITY||LS mean difference|-32.8|STANDARD_ERROR_OF_MEAN|14.66||0.0383|TWO_SIDED|80.0|-52.26|-13.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.26|-52.26|0.0383
73970604|NCT03858634|147481213|SUPERIORITY||LS mean difference|-26.1|STANDARD_ERROR_OF_MEAN|37.1||0.5322|TWO_SIDED|80.0|-86.66|34.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||34.65|-86.66|0.5322
73970605|NCT03858634|147481213|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|13.71||0.6577|TWO_SIDED|80.0|-24.38|12.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||12.03|-24.38|0.6577
73970606|NCT03858634|147481213|SUPERIORITY||LS mean difference|-38.3|STANDARD_ERROR_OF_MEAN|67.21||0.6259|TWO_SIDED|80.0|-165.08|88.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||88.40|-165.08|0.6259
73970607|NCT03858634|147481213|SUPERIORITY||LS mean difference|-35.7|STANDARD_ERROR_OF_MEAN|15.27||0.0312|TWO_SIDED|80.0|-56.01|-15.38||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-15.38|-56.01|0.0312
73970608|NCT03858634|147481213|SUPERIORITY||LS mean difference|-108.3|STANDARD_ERROR_OF_MEAN|18.73||0.0103|TWO_SIDED|80.0|-138.97|-77.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-77.61|-138.97|0.0103
73970609|NCT03858634|147481213|SUPERIORITY||LS mean difference|10.0|STANDARD_ERROR_OF_MEAN|12.43||0.433|TWO_SIDED|80.0|-6.59|26.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||26.56|-6.59|0.4330
73970610|NCT03858634|147481213|SUPERIORITY||LS mean difference|-37.7|STANDARD_ERROR_OF_MEAN|64.23||0.6165|TWO_SIDED|80.0|-158.82|83.39||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||83.39|-158.82|0.6165
73970611|NCT03858634|147481213|SUPERIORITY||LS mean difference|-32.0|STANDARD_ERROR_OF_MEAN|15.13||0.0488|TWO_SIDED|80.0|-52.11|-11.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-11.84|-52.11|0.0488
74088138|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.67||||0.4859|TWO_SIDED|95.0|0.39|7.11|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.11|0.39|0.4859
73862867|NCT02739321|147271683|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||||||0.285
73862868|NCT02739321|147271684|SUPERIORITY|||||||0.089|||||||Mixed Models Analysis|||||||0.089
73862869|NCT02739321|147271685|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.040
73862870|NCT02739321|147271686|SUPERIORITY|||||||0.471|||||||Mixed Models Analysis|||||||0.471
73970612|NCT03858634|147481213|SUPERIORITY||LS mean difference|-19.2|STANDARD_ERROR_OF_MEAN|39.9||0.6636|TWO_SIDED|80.0|-84.53|46.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||46.16|-84.53|0.6636
73970613|NCT03858634|147481213|SUPERIORITY||LS mean difference|23.9|STANDARD_ERROR_OF_MEAN|11.75||0.0583|TWO_SIDED|80.0|8.18|39.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||39.52|8.18|0.0583
73970614|NCT03858634|147481213|SUPERIORITY||LS mean difference|-45.1|STANDARD_ERROR_OF_MEAN|54.87||0.4975|TWO_SIDED|80.0|-148.55|58.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||58.36|-148.55|0.4975
73970615|NCT03858634|147481213|SUPERIORITY||LS mean difference|-30.5|STANDARD_ERROR_OF_MEAN|15.54||0.0653|TWO_SIDED|80.0|-51.17|-9.82||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-9.82|-51.17|0.0653
73970616|NCT03858634|147481213|SUPERIORITY||LS mean difference|-23.4|STANDARD_ERROR_OF_MEAN|43.98||0.6316|TWO_SIDED|80.0|-95.42|48.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||48.62|-95.42|0.6316
73970617|NCT03858634|147481213|SUPERIORITY||LS mean difference|26.6|STANDARD_ERROR_OF_MEAN|14.68||0.0874|TWO_SIDED|80.0|7.05|46.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||46.18|7.05|0.0874
73862871|NCT02739321|147271687|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||||||0.015
73862872|NCT02739321|147271688|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
73862873|NCT02739321|147271689|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of mattress technology was 5.61 (SE = 0.25).|||
73970618|NCT03858634|147481213|SUPERIORITY||LS mean difference|-45.0|STANDARD_ERROR_OF_MEAN|50.39||0.4662|TWO_SIDED|80.0|-139.99|50.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||50.03|-139.99|0.4662
73970619|NCT03858634|147481213|SUPERIORITY||LS mean difference|-25.6|STANDARD_ERROR_OF_MEAN|15.12||0.1073|TWO_SIDED|80.0|-45.76|-5.51||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-5.51|-45.76|0.1073
73970620|NCT03858634|147481213|SUPERIORITY||LS mean difference|-23.3|STANDARD_ERROR_OF_MEAN|42.31||0.6197|TWO_SIDED|80.0|-92.62|45.96||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||45.96|-92.62|0.6197
73970621|NCT03858634|147481213|SUPERIORITY||LS mean difference|20.6|STANDARD_ERROR_OF_MEAN|14.97||0.1868|TWO_SIDED|80.0|0.63|40.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||40.55|0.63|0.1868
73970622|NCT03858634|147481213|SUPERIORITY||LS mean difference|-55.0|STANDARD_ERROR_OF_MEAN|43.32||0.3321|TWO_SIDED|80.0|-136.65|26.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||26.71|-136.65|0.3321
73970623|NCT03858634|147481213|SUPERIORITY||LS mean difference|-24.8|STANDARD_ERROR_OF_MEAN|15.67||0.131|TWO_SIDED|80.0|-45.64|-3.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-3.95|-45.64|0.1310
73970624|NCT03858634|147481213|SUPERIORITY||LS mean difference|-12.0|STANDARD_ERROR_OF_MEAN|46.49||0.8128|TWO_SIDED|80.0|-88.15|64.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||64.13|-88.15|0.8128
73970625|NCT03858634|147481213|SUPERIORITY||LS mean difference|24.7|STANDARD_ERROR_OF_MEAN|14.23||0.1004|TWO_SIDED|80.0|5.75|43.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||43.69|5.75|0.1004
73970626|NCT03858634|147481213|SUPERIORITY||LS mean difference|-62.8|STANDARD_ERROR_OF_MEAN|44.81||0.2962|TWO_SIDED|80.0|-147.28|21.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||21.71|-147.28|0.2962
73862874|NCT02739321|147271690|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of actigraph watch was 5.51 (SE = 0.13).|||
73862875|NCT02739321|147271691|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely difficult, 7 = extremely easy) that was used to rate ease of use.|||||||||||||||||The mean rating of parent reported ease of us of the mattress technology was 6.04 (SE = 0.15).|||
73970627|NCT03858634|147481213|SUPERIORITY||LS mean difference|-26.5|STANDARD_ERROR_OF_MEAN|16.4||0.1236|TWO_SIDED|80.0|-48.31|-4.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-4.67|-48.31|0.1236
73970628|NCT03858634|147481213|SUPERIORITY||LS mean difference|-4.5|STANDARD_ERROR_OF_MEAN|45.55||0.9276|TWO_SIDED|80.0|-79.1|70.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||70.11|-79.10|0.9276
73970629|NCT03858634|147481213|SUPERIORITY||LS mean difference|19.5|STANDARD_ERROR_OF_MEAN|13.46||0.1657|TWO_SIDED|80.0|1.55|37.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||37.45|1.55|0.1657
73970630|NCT03858634|147481213|SUPERIORITY||LS mean difference|-58.4|STANDARD_ERROR_OF_MEAN|47.8||0.3461|TWO_SIDED|80.0|-148.54|31.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||31.71|-148.54|0.3461
73862876|NCT02739321|147271692|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
73970631|NCT03858634|147481213|SUPERIORITY||LS mean difference|-27.6|STANDARD_ERROR_OF_MEAN|16.51||0.1118|TWO_SIDED|80.0|-49.58|-5.64||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-5.64|-49.58|0.1118
73929753|NCT06425458|147389336|OTHER|||||||0.0719||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Purpose in Life (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.0719
73929754|NCT06425458|147389336|OTHER|||||||0.7991||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Locus of Control (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.7991
73929755|NCT06425458|147389336|OTHER|||||||0.2208||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Self-Efficacy (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.2208
73929756|NCT06425458|147389336|OTHER||Spearman partial correlation coefficient|0.37|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Self-Esteem). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
73929757|NCT06425458|147389336|OTHER||Spearman partial correlation coefficient|-0.29|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Purpose in Life). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
73929758|NCT06425458|147389336|OTHER||Spearman partial correlation coefficient|-0.58|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Locus of Control). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
73929759|NCT06425458|147389336|OTHER||Spearman partial correlation coefficient|-0.14|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Self-Efficacy). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
73970632|NCT03858634|147481213|SUPERIORITY||LS mean difference|-18.9|STANDARD_ERROR_OF_MEAN|43.24||0.6912|TWO_SIDED|80.0|-89.75|51.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||51.89|-89.75|0.6912
74088139|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.6|3.17|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.17|1.60|<.0001
73929760|NCT00445328|147389339|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is based on chi-square test with alpha as 0.01.|Chi-squared|||||||1.0000
73929761|NCT00445328|147389341|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Chi-squared|||Major Bleeding||||1.0000
73929762|NCT00445328|147389344|SUPERIORITY_OR_OTHER|||||||0.1355||95.0|||||Chi-squared|||||||0.1355
73929763|NCT02782949|147389374|SUPERIORITY|||||||0.399|||||||Wilcoxon Rank-Sum test|||||||0.3990
73929764|NCT02782949|147389377|SUPERIORITY|||||||0.74|||||||Fisher Exact|||||||0.74
73929765|NCT02489318|147389402|SUPERIORITY||Hazard Ratio (HR)|0.484|||<|0.0001|TWO_SIDED|95.0|0.391|0.6|||Log Rank|||||0.600|0.391|<0.0001
73929766|NCT02489318|147389403|SUPERIORITY||Hazard Ratio (HR)|0.651|||<|0.0001|TWO_SIDED|95.0|0.534|0.793|||Log Rank|||||0.793|0.534|<0.0001
73929767|NCT02489318|147389404|SUPERIORITY||Hazard Ratio (HR)|0.469|||<|0.0001|TWO_SIDED|95.0|0.35|0.63|||Log Rank|||||0.630|0.350|<.0001
73929768|NCT02489318|147389405|SUPERIORITY||Hazard Ratio (HR)|0.868||||0.1966|TWO_SIDED|95.0|0.7|1.076|||Log Rank|||||1.076|0.700|0.1966
73929769|NCT02489318|147389406|SUPERIORITY||Hazard Ratio (HR)|0.794||||0.1563|TWO_SIDED|95.0|0.576|1.094|||Log Rank|||||1.094|0.576|0.1563
73929770|NCT02489318|147389407|SUPERIORITY||Hazard Ratio (HR)|0.857||||0.3608|TWO_SIDED|95.0|0.615|1.194|||Log Rank|||||1.194|0.615|0.3608
73929771|NCT01276314|147389436|OTHER|||||||0.01||||||The p-value was analyzed for SJS/TEN participants with \>10% body surface area detachment.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.||||0.01
73929772|NCT01276314|147389436|OTHER|||||||0.06||||||This p-value was analyzed for DRESS participants.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.||||0.06
73929773|NCT00749775|147389485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 4 weeks does not differ from that at baseline.||||<0.001
73929774|NCT00749775|147389485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 8 weeks does not differ from that at baseline.||||<0.001
73929775|NCT00749775|147389485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 12 weeks does not differ from that at baseline.||||<0.001
73929776|NCT00749775|147389485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at last evaluation date does not differ from that at baseline.||||<0.001
73929777|NCT00749775|147389486|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 4 weeks does not differ from that at baseline.||||<0.001
73929778|NCT00749775|147389486|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 8 weeks does not differ from that at baseline.||||<0.001
73929779|NCT00749775|147389486|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 12 weeks does not differ from that at baseline.||||<0.001
73929780|NCT00749775|147389486|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at last evaluation date does not differ from that at baseline.||||<0.001
73929781|NCT04300296|147389488|OTHER||Posterior median difference|-13.9|||||TWO_SIDED|95.0|-44.8|19.3|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||19.3|-44.8|
73929782|NCT04300296|147389488|OTHER||Posterior median difference|14.1|||||TWO_SIDED|95.0|-17.0|40.7|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||40.7|-17.0|
73929783|NCT04300296|147389488|OTHER||Posterior median difference|6.5|||||TWO_SIDED|95.0|-25.4|35.4|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||35.4|-25.4|
73929784|NCT00958776|147389519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.973|TWO_SIDED|95.0|0.69|1.55|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.55|0.69|0.973
74088140|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.5|2.96|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.50|<.0001
73929785|NCT00958776|147389521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.558|TWO_SIDED|95.0|0.75|1.72|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.72|0.75|0.558
73929786|NCT00958776|147389522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.633|TWO_SIDED|95.0|0.59|1.31|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.31|0.59|0.633
73929787|NCT00958776|147389523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.747|TWO_SIDED|95.0|0.92|2.32|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||2.32|0.92|0.747
73929788|NCT00958776|147389525|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.303|TWO_SIDED|95.0|0.41|2.98|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio is calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at baseline, use of supplemental oxygen at baseline, influenza season, and influenza type.|||2.98|0.41|0.303
73929789|NCT00958776|147389527|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.||||||0.768
73970633|NCT03858634|147481213|SUPERIORITY||LS mean difference|22.9|STANDARD_ERROR_OF_MEAN|13.07||0.0973|TWO_SIDED|80.0|5.5|40.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||40.35|5.50|0.0973
73970634|NCT03858634|147481213|SUPERIORITY||LS mean difference|-57.7|STANDARD_ERROR_OF_MEAN|40.33||0.289|TWO_SIDED|80.0|-133.72|18.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||18.37|-133.72|0.2890
73970635|NCT03858634|147481213|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|17.68||0.231|TWO_SIDED|80.0|-45.43|1.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||1.60|-45.43|0.2310
73970636|NCT03858634|147481213|SUPERIORITY||LS mean difference|-12.7|STANDARD_ERROR_OF_MEAN|45.17||0.7967|TWO_SIDED|80.0|-86.69|61.28||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||61.28|-86.69|0.7967
73970637|NCT03858634|147481213|SUPERIORITY||LS mean difference|16.5|STANDARD_ERROR_OF_MEAN|14.98||0.2868|TWO_SIDED|80.0|-3.5|36.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||36.44|-3.50|0.2868
73970638|NCT03858634|147481213|SUPERIORITY||LS mean difference|-64.9|STANDARD_ERROR_OF_MEAN|38.83||0.2369|TWO_SIDED|80.0|-138.08|8.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||8.37|-138.08|0.2369
73970639|NCT03858634|147481213|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|17.34||0.2228|TWO_SIDED|80.0|-44.97|1.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||1.17|-44.97|0.2228
74088141|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.91||||0.002|TWO_SIDED|95.0|1.27|2.87|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.27|0.0020
73929790|NCT00958776|147389528|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.||||||0.758
73929791|NCT01948375|147389562|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73970640|NCT03858634|147481213|SUPERIORITY||LS mean difference|-14.9|STANDARD_ERROR_OF_MEAN|47.51||0.774|TWO_SIDED|80.0|-92.74|62.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||62.89|-92.74|0.7740
73929792|NCT01948375|147389564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.007||95.0|1.26|4.4||For the comparison of direct effect of placebo needle and real needle, p=0.007|Generalized Estimating Equation|||||4.40|1.26|0.007
73970641|NCT03858634|147481213|SUPERIORITY||LS mean difference|15.1|STANDARD_ERROR_OF_MEAN|14.14||0.3|TWO_SIDED|80.0|-3.74|33.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||33.98|-3.74|0.3000
73970642|NCT03858634|147481213|SUPERIORITY||LS mean difference|-72.4|STANDARD_ERROR_OF_MEAN|31.37||0.1472|TWO_SIDED|80.0|-131.59|-13.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-13.30|-131.59|0.1472
73970643|NCT03858634|147481213|SUPERIORITY||LS mean difference|-12.4|STANDARD_ERROR_OF_MEAN|20.56||0.5536|TWO_SIDED|80.0|-39.77|14.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||14.94|-39.77|0.5536
73970644|NCT03858634|147481213|SUPERIORITY||LS mean difference|-17.6|STANDARD_ERROR_OF_MEAN|43.65||0.7131|TWO_SIDED|80.0|-89.13|53.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||53.84|-89.13|0.7131
73929793|NCT01948375|147389565|SUPERIORITY_OR_OTHER||||||=|0.006||||||"for the comparison of difference of acupuncture pain in two periods between the two groups,t=-2.88, p=0.006.~t=-2.88 refers to the t value of t test."|t-test, 2 sided|||||||=0.006
73929794|NCT01948375|147389566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63|||=|0.048||95.0|1.01|2.64||For the comparison of direct effect of placebo needle and real needle, p=0.048|Generalized Estimating Equation|||||2.64|1.01|=0.048
73929795|NCT04537806|147389569|SUPERIORITY||Proc Genmod|0.0||||1|TWO_SIDED|95.0|-31.8|31.8|||Chi-squared||Estimates for treatment, and the corresponding 95% confidence interval (CI) were estimated using Proc Genmod method, with treatment as a factor and age groups as a covariate variable.|||31.8|-31.8|1.0000
73929796|NCT03019627|147389572|SUPERIORITY||difference in least square means|-3.83|||=|0.428|TWO_SIDED|95.0|-13.34|5.68|||ANCOVA|||Frequency statistical analysis||5.68|-13.34|=0.428
73929797|NCT03019627|147389572|SUPERIORITY||difference in least square means|0.16|||=|0.974|TWO_SIDED|95.0|-9.45|9.76|||ANCOVA|||Severity statistical analysis||9.76|-9.45|=0.974
73929798|NCT03019627|147389573|SUPERIORITY||Difference in least square means|-1.12|||=|0.783|TWO_SIDED|95.0|-9.14|6.91|||ANCOVA|||frequency statistical analysis - week 4||6.91|-9.14|=0.783
73929799|NCT03019627|147389573|SUPERIORITY||difference in least square means|-3.82|||=|0.461|TWO_SIDED|95.0|-14.1|6.41|||ANCOVA|||Frequency statistical analysis - week 8||6.41|-14.1|=0.461
73929800|NCT03019627|147389573|SUPERIORITY||difference in least square means|-15.3|||=|0.004|TWO_SIDED|95.0|-25.6|-4.97|||ANCOVA|||Frequency statistical analysis - week 12||-4.97|-25.6|=0.004
73929801|NCT03019627|147389573|SUPERIORITY||difference in least square means|2.55|||=|0.544|TWO_SIDED|95.0|-5.72|10.82|||ANCOVA|||Severity statistical analysis - week 4||10.82|-5.72|=0.544
73929802|NCT03019627|147389573|SUPERIORITY||difference in least square means|1.06|||=|0.837|TWO_SIDED|95.0|-9.12|11.24|||ANCOVA|||Severity statistical analysis - week 8||11.24|-9.12|=0.837
73929803|NCT03019627|147389573|SUPERIORITY||difference in least square means|-13.8|||=|0.007|TWO_SIDED|95.0|-23.7|3.88|||ANCOVA|||Severity statistical analysis - week 12||3.88|-23.7|=0.007
73929804|NCT03019627|147389574|SUPERIORITY||Difference in least square means|-0.7|||=|0.046|TWO_SIDED|95.0|-1.38|-0.01|||ANCOVA|||week 4||-0.01|-1.38|=0.046
73929805|NCT03019627|147389574|SUPERIORITY||Difference in least square means|-0.3|||=|0.425|TWO_SIDED|95.0|-1.05|0.44|||ANCOVA|||week 8||0.44|-1.05|=0.425
73929806|NCT03019627|147389574|SUPERIORITY||Difference in least square means|-0.09|||=|0.788|TWO_SIDED|95.0|-0.76|0.58|||ANCOVA|||week 12||0.58|-0.76|=0.788
73929807|NCT03019627|147389575|SUPERIORITY||Difference in least square means|-0.71|||=|0.265|TWO_SIDED|95.0|-1.95|0.54|||ANCOVA|||week 4||0.54|-1.95|=0.265
73929808|NCT03019627|147389575|SUPERIORITY||Difference in least square means|-1.38|||=|0.026|TWO_SIDED|95.0|-2.59|-0.17|||ANCOVA|||week 8||-0.17|-2.59|=0.026
73929809|NCT03019627|147389575|SUPERIORITY||Difference in least square means|-0.6|||=|0.361|TWO_SIDED|95.0|-1.9|0.7|||ANCOVA|||week 12||0.70|-1.90|=0.361
73929810|NCT03019627|147389576|SUPERIORITY||Difference in least square means|-0.25|||=|0.323|TWO_SIDED|95.0|-0.76|0.25|||ANCOVA|||week 4||0.25|-0.76|=0.323
73929811|NCT03019627|147389576|SUPERIORITY||Difference in least square means|0.03|||=|0.908|TWO_SIDED|95.0|-0.55|0.62|||ANCOVA|||week 8||0.62|-0.55|=0.908
73929812|NCT03019627|147389576|SUPERIORITY||Difference in least square means|-0.12|||=|0.702|TWO_SIDED|95.0|-0.76|0.52|||ANCOVA|||week 12||0.52|-0.76|=0.702
73929813|NCT03019627|147389577|SUPERIORITY||Difference in least square means|5.75|||=|0.003|TWO_SIDED|95.0|2.02|9.48|||ANCOVA|||||9.48|2.02|=0.003
73929814|NCT05107128|147389615|SUPERIORITY||Difference in Least Square (LS) Means|-1.1|STANDARD_ERROR_OF_MEAN|0.81||0.1675|TWO_SIDED|95.0|-2.7|0.5||The p-value was obtained from Mixed Model for Repeated Measures (MMRM) model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and SDMT score at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.5|-2.7|0.1675
73929815|NCT05107128|147389616|SUPERIORITY||Difference in LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.9||0.4872|TWO_SIDED|95.0|-2.4|1.1||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and UHDRS - Independence Scale at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||1.1|-2.4|0.4872
73929816|NCT05107128|147389617|SUPERIORITY||Difference in LS Means|-5.0|STANDARD_ERROR_OF_MEAN|6.04||0.4089|TWO_SIDED|95.0|-17.0|6.9||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and SDMT score at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||6.9|-17.0|0.4089
73929817|NCT05107128|147389618|SUPERIORITY||Difference in LS Means|0.7|STANDARD_ERROR_OF_MEAN|1.26||0.5766|TWO_SIDED|95.0|-1.78|3.19||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and a baseline value as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||3.19|-1.78|0.5766
73929818|NCT05107128|147389619|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.64||0.1777|TWO_SIDED|95.0|-2.13|0.39||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and baseline value as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.39|-2.13|0.1777
73929819|NCT05107128|147389620|SUPERIORITY||Difference in LS Means|3.9|STANDARD_ERROR_OF_MEAN|1.76||0.0291|TWO_SIDED|95.0|0.4|7.3||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and Hi-DEF at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||7.3|0.4|0.0291
73929820|NCT05107128|147389621|SUPERIORITY||Difference in LS Means|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2923|TWO_SIDED|95.0|-0.3|0.1||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and CGI at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.1|-0.3|0.2923
73929821|NCT05459129|147389630|SUPERIORITY||Difference in pCR Rates|33.33|||||TWO_SIDED|95.0|-33.23|99.9||||||||99.90|-33.23|
73929822|NCT05459129|147389631|SUPERIORITY||Difference in pRR|33.33|||||TWO_SIDED|95.0|-21.05|87.72||||||||87.72|-21.05|
73929823|NCT05459129|147389632|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.11|3.91|||||HR was estimated by Cox regression. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of median EFS per arm or HR between the arms.|||3.91|0.11|
74088142|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.53|3.4|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.40|1.53|<.0001
74088143|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0107|TWO_SIDED|95.0|1.21|4.14|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.14|1.21|0.0107
74088144|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0126|TWO_SIDED|95.0|1.18|4.02|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.02|1.18|0.0126
74088145|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.67||||0.1516|TWO_SIDED|95.0|0.7|10.26|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||10.26|0.70|0.1516
74088146|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|4.49||||0.021|TWO_SIDED|95.0|1.25|16.05|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||16.05|1.25|0.0210
74088147|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0034|TWO_SIDED|95.0|1.18|2.31|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.18|0.0034
73929824|NCT05459129|147389633|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.13|6.43|||||HR was estimated by Cox regression. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of media RFS per arm or HR between the arms.|||6.43|0.13|
73929825|NCT05459129|147389635|SUPERIORITY||Difference in ORR|16.67|||||TWO_SIDED|95.0|-54.99|88.32||||||||88.32|-54.99|
73929826|NCT05459129|147389636|SUPERIORITY||Difference in Event Free Rate|16.67|||||TWO_SIDED|95.0|-31.42|64.75|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.|3 Months Analysis||64.75|-31.42|
73970645|NCT03858634|147481213|SUPERIORITY||LS mean difference|13.9|STANDARD_ERROR_OF_MEAN|15.27||0.3762|TWO_SIDED|80.0|-6.49|34.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||34.24|-6.49|0.3762
73970646|NCT03858634|147481213|SUPERIORITY||LS mean difference|-74.1|STANDARD_ERROR_OF_MEAN|31.37||0.1419|TWO_SIDED|80.0|-133.26|-14.97||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-14.97|-133.26|0.1419
73970647|NCT03858634|147481213|SUPERIORITY||LS mean difference|-11.6|STANDARD_ERROR_OF_MEAN|20.74||0.5817|TWO_SIDED|80.0|-39.22|15.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||15.95|-39.22|0.5817
73970648|NCT03858634|147481215|SUPERIORITY||LS mean difference|27.7|STANDARD_ERROR_OF_MEAN|55.77||0.6532|TWO_SIDED|80.0|-63.6|119.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||119.06|-63.60|0.6532
73970649|NCT03858634|147481215|SUPERIORITY||LS mean difference|23.6|STANDARD_ERROR_OF_MEAN|9.23||0.0187|TWO_SIDED|80.0|11.38|35.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||35.85|11.38|0.0187
73970650|NCT03858634|147481215|SUPERIORITY||LS mean difference|-39.3|STANDARD_ERROR_OF_MEAN|44.53||0.4707|TWO_SIDED|80.0|-123.27|44.68||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||44.68|-123.27|0.4707
73970651|NCT03858634|147481215|SUPERIORITY||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|4.81||0.7108|TWO_SIDED|80.0|-8.22|4.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||4.59|-8.22|0.7108
73970652|NCT03858634|147481215|SUPERIORITY||LS mean difference|22.4|STANDARD_ERROR_OF_MEAN|60.36||0.7355|TWO_SIDED|80.0|-76.47|121.23||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||121.23|-76.47|0.7355
73970653|NCT03858634|147481215|SUPERIORITY||LS mean difference|16.9|STANDARD_ERROR_OF_MEAN|13.27||0.2167|TWO_SIDED|80.0|-0.66|34.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||34.52|-0.66|0.2167
73970654|NCT03858634|147481215|SUPERIORITY||LS mean difference|-63.5|STANDARD_ERROR_OF_MEAN|60.8||0.4058|TWO_SIDED|80.0|-178.16|51.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||51.13|-178.16|0.4058
73970655|NCT03858634|147481215|SUPERIORITY||LS mean difference|-6.4|STANDARD_ERROR_OF_MEAN|6.43||0.3323|TWO_SIDED|80.0|-14.95|2.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||2.15|-14.95|0.3323
73970656|NCT03858634|147481215|SUPERIORITY||LS mean difference|34.3|STANDARD_ERROR_OF_MEAN|68.11||0.6496|TWO_SIDED|80.0|-77.29|145.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||145.80|-77.29|0.6496
73970657|NCT03858634|147481215|SUPERIORITY||LS mean difference|13.8|STANDARD_ERROR_OF_MEAN|12.76||0.2925|TWO_SIDED|80.0|-3.12|30.7||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||30.70|-3.12|0.2925
73970658|NCT03858634|147481215|SUPERIORITY||LS mean difference|-70.7|STANDARD_ERROR_OF_MEAN|67.98||0.4074|TWO_SIDED|80.0|-198.92|57.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||57.46|-198.92|0.4074
73929827|NCT05459129|147389636|SUPERIORITY||Difference in Event Free Rate|0.0|||||TWO_SIDED|95.0|-53.34|53.34|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.|6 Months Analysis||53.34|-53.34|
73929828|NCT05459129|147389637|SUPERIORITY||Difference in Event Free Rate|-13.33|||||TWO_SIDED|95.0|-64.83|38.16|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made|3 Months Analysis||38.16|-64.83|
73929829|NCT05459129|147389637|SUPERIORITY||Difference in Event Free Rate|6.67|||||TWO_SIDED|95.0|-50.49|63.82|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made|6 Months Analysis||63.82|-50.49|
73929830|NCT02504372|147389662|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.68|0.96|||||HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.96|0.68|
73929831|NCT02504372|147389663|OTHER||Hazard Ratio (HR)|0.83||||0.13499|TWO_SIDED|95.0|0.59|1.16|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||1.16|0.59|0.13499
73929832|NCT02504372|147389664|OTHER||Hazard Ratio (HR)|0.78||||0.01327|TWO_SIDED|95.0|0.62|0.97|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.97|0.62|0.01327
73929833|NCT02504372|147389671|OTHER||Hazard Ratio (HR)|0.76||||0.00143|TWO_SIDED|95.0|0.63|0.91|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.91|0.63|0.00143
73929834|NCT04530552|147389702|OTHER||See above|0.895|||||TWO_SIDED|||||||||Posterior probability of observing a response rate ≥ 50%||||
73970659|NCT03858634|147481215|OTHER||LS mean difference|-15.5|STANDARD_ERROR_OF_MEAN|10.56||0.1584|TWO_SIDED|80.0|-29.6|-1.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-1.49|-29.60|0.1584
74088148|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.75||||0.001|TWO_SIDED|95.0|1.26|2.45|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.26|0.0010
74088149|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0014|TWO_SIDED|95.0|1.27|2.71|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.71|1.27|0.0014
73929835|NCT04530552|147389702|OTHER||See above|0.943|||||TWO_SIDED|||||||||Posterior probability of observing a response rate ≥ 25%||||
73929836|NCT04530552|147389703|OTHER|Two-sided paired t-test at 2.5% significance level (Bonferroni correction)||||||0.034||||||Two-sided paired t-test at 2.5% significance level (Bonferroni correction)|paired t-test|||||||0.034
73929837|NCT04530552|147389703|OTHER|||||||0.252||||||Two-sided paired t-test at 2.5% significance level (Bonferroni correction)|paired t-test|||||||0.252
73929838|NCT04530552|147389704|OTHER|||||||1||||||Significance level of 2.5% (Bonferroni correction)|Pearson correlation|||Correlation with % change PSA at end-of-intervention||||1.0
73929839|NCT04530552|147389704|OTHER|||||||1||||||Significance level of 2.5% (Bonferroni correction)|Pearson correlation|||Correlation with % change PSA at end-of-intervention||||1.0
73929840|NCT04530552|147389705|OTHER|||||||0.658||||||two-sided paired t-test (no Bonferroni adjustment)|paired t-test|||||||0.658
73929841|NCT04530552|147389705|OTHER|||||||0.167||||||Two-sided paired t-test (no Bonferroni adjustment)|paired t-test|||||||0.167
73929842|NCT01946204|147389762|SUPERIORITY||Hazard Ratio (HR)|0.271|||<|0.0001|TWO_SIDED|95.0|0.219|0.335|||Log Rank|||Statistical Analysis for TTM by BICR (US Regulatory)||0.335|0.219|<0.0001
73929843|NCT01946204|147389762|SUPERIORITY||Hazard Ratio (HR)|0.279|||<|0.0001|TWO_SIDED|95.0|0.227|0.342|||Log Rank|||Statistical Analysis for TTM by BICR (Ex-US Regulatory)||0.342|0.227|<0.0001
73929844|NCT01946204|147389763|SUPERIORITY||Hazard Ratio (HR)|0.291|||<|0.0001|TWO_SIDED|95.0|0.238|0.356|||Log Rank|||Statistical Analysis for PFS by BICR (US Regulatory)||0.356|0.238|<0.0001
73929845|NCT01946204|147389763|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.247|0.364|||Log Rank|||Statistical Analysis for PFS by BICR (EX-US Regulatory)||0.364|0.247|<0.0001
73929846|NCT01946204|147389764|SUPERIORITY||Hazard Ratio (HR)|0.447|||<|0.0001|TWO_SIDED|95.0|0.315|0.634|||Log Rank|||Statistical Analysis for Time to Symptomatic Progression||0.634|0.315|<0.0001
73929847|NCT01946204|147389767|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.227|0.346|||Log Rank|||Statistical Analysis for MFS by BICR (US Regulatory)||0.346|0.227|<0.0001
73929848|NCT01946204|147389767|SUPERIORITY||Hazard Ratio (HR)|0.297|||<|0.0001|TWO_SIDED|95.0|0.244|0.362|||Log Rank|||Statistical Analysis for MFS by BICR (Ex-US Regulatory)||0.362|0.244|<0.0001
73929849|NCT00376168|147389788|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."||||<0.0001
73970660|NCT03858634|147481215|SUPERIORITY||LS mean difference|-22.8|STANDARD_ERROR_OF_MEAN|54.04||0.7013|TWO_SIDED|80.0|-111.31|65.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||65.69|-111.31|0.7013
73970661|NCT03858634|147481215|SUPERIORITY||LS mean difference|13.4|STANDARD_ERROR_OF_MEAN|16.35||0.423|TWO_SIDED|80.0|-8.3|35.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||35.05|-8.30|0.4230
74029614|NCT02202031|147613733|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.0786|TWO_SIDED|95.0|-1.4|0.07|||ANCOVA|change from baseline, adjusted for baseline value||||0.07|-1.4|0.0786
74029615|NCT02202031|147613734|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.2284|TWO_SIDED|95.0|-2.87|0.79|||ANCOVA|change from baseline, adjusted for baseline value||||0.79|-2.87|0.2284
74029616|NCT02202031|147613735|SUPERIORITY||Mean Difference (Final Values)|-1.71||||0.0335|TWO_SIDED|95.0|-3.28|-0.13|||ANCOVA|change from baseline, adjusted for baseline value||||-0.13|-3.28|0.0335
74029617|NCT02202031|147613736|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.8408|TWO_SIDED|95.0|-0.66|0.81|||ANCOVA|change from baseline, adjusted for baseline value||||0.81|-0.66|0.8408
74029618|NCT02202031|147613737|SUPERIORITY|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic|Mean Difference (Final Values)|0.14||||0.5578|TWO_SIDED|95.0|-0.32|0.6|||ANCOVA|||||0.60|-0.32|0.5578
74029619|NCT02202031|147613738|SUPERIORITY|||||||0.5578|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||||0.5578
74029620|NCT02202031|147613739|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.7301|TWO_SIDED|95.0|-0.79|0.31|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||0.31|-0.79|0.7301
74029621|NCT02202031|147613740|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.6646|TWO_SIDED|95.0|-0.89|0.04|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic||||0.04|-0.89|0.6646
74029622|NCT02202031|147613741|SUPERIORITY|||||||0.4993|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||||0.4993
74029623|NCT02202031|147613742|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.7506|TWO_SIDED|95.0|-3.05|4.23|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||4.23|-3.05|0.7506
74029624|NCT02202031|147613743|SUPERIORITY||Mean Difference (Final Values)|-1.55||||0.6268|TWO_SIDED|95.0|-6.98|3.87|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||3.87|-6.98|0.6268
74029625|NCT00076219|147613748|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|STANDARD_ERROR_OF_MEAN|0.12||0.47|TWO_SIDED|95.0|0.86|1.4|||Regression, Logistic|||||1.40|0.86|0.47
73929850|NCT00376168|147389788|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||threshold for statistical significance = 0.025|one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."||||<0.0001
74029626|NCT03078608|147613764|SUPERIORITY||F statistic|0.0||||1|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||1.00
74029627|NCT03078608|147613765|SUPERIORITY||F statistic|2.58||||0.11|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.11
73929851|NCT00376168|147389789|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0041
73929852|NCT00376168|147389789|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||<0.0001
74029628|NCT03078608|147613766|SUPERIORITY||F statistic|0.07||||0.79|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.79
74029629|NCT03078608|147613767|SUPERIORITY||F statistic|1.17||||0.29|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.29
74029630|NCT03078608|147613768|SUPERIORITY||F statistic|0.18||||0.67|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.67
74029631|NCT03078608|147613769|SUPERIORITY||F statistic|1.41||||0.24|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.24
74029632|NCT03078608|147613770|SUPERIORITY||F statistic|1.36||||0.25|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.25
74029633|NCT03078608|147613771|SUPERIORITY||F statistic|0.53||||0.47|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.47
74029634|NCT03078608|147613772|SUPERIORITY||F statistic|1.54||||0.23|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.23
74029635|NCT03078608|147613773|SUPERIORITY||F statistic|0.8||||0.39|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.39
74029636|NCT02853331|147613778|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.00012|TWO_SIDED|95.0|0.56|0.84|||Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||0.84|0.56|0.00012
74029637|NCT02853331|147613779|SUPERIORITY||Hazard Ratio (HR)|0.53||||5e-05|TWO_SIDED|95.0|0.38|0.74|||Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||0.74|0.38|0.00005
74029638|NCT02853331|147613780|SUPERIORITY||Difference in percentages|23.6|||<|0.0001|TWO_SIDED|95.0|17.2|29.9|||Miettinen & Nurminen method|H0: difference in %=0 versus H1: difference in % \>0|Difference in percentages based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||29.9|17.2|<0.0001
74029639|NCT02853331|147613781|SUPERIORITY||Difference in percentages|11.0|||||TWO_SIDED|95.0|4.8|17.0|||||Difference in percentages based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||17.0|4.8|
74029640|NCT02086565|147613804|SUPERIORITY||Group differences in expected 12 month c|-0.21|||||TWO_SIDED|95.0|-0.56|0.15||||||||0.15|-0.56|
73929853|NCT00376168|147389790|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0010
73929854|NCT00376168|147389790|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||<0.0001
73929855|NCT00376168|147389791|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0460
73929856|NCT00376168|147389791|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0031
73929857|NCT01857063|147389821|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.01||||0.913|TWO_SIDED|95.0|-0.11|0.1||Longitudinal Data Analysis (LDA) model with baseline TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|Longitudinal Data Analysis (LDA)|||||0.10|-0.11|0.913
73970662|NCT03858634|147481215|SUPERIORITY||LS mean difference|-60.6|STANDARD_ERROR_OF_MEAN|57.96||0.4055|TWO_SIDED|80.0|-169.9|48.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||48.69|-169.90|0.4055
73970663|NCT03858634|147481215|SUPERIORITY||LS mean difference|-22.7|STANDARD_ERROR_OF_MEAN|11.82||0.0709|TWO_SIDED|80.0|-38.41|-6.96||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.96|-38.41|0.0709
74029641|NCT02086565|147613805|SUPERIORITY||Group differences in expected 12 month c|0.19|||||TWO_SIDED|95.0|-0.27|0.68|||||Estimation parameter: Other. Group differences in expected 12 month change from baseline|||0.68|-0.27|
74029642|NCT02086565|147613806|SUPERIORITY||Group differences in expected 12 month c|-0.6|||||TWO_SIDED|95.0|-2.21|0.97||||||||0.97|-2.21|
74029643|NCT02086565|147613807|SUPERIORITY||Group differences in expected 12 month c|-0.53|||||TWO_SIDED|95.0|-1.08|-0.24||||||||-0.24|-1.08|
74088150|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.46|3.1|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.46|<.0001
74088151|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.61||||0.0007|TWO_SIDED|95.0|1.49|4.55|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.55|1.49|0.0007
73929858|NCT01857063|147389823|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0||||0.953|TWO_SIDED|95.0|-0.17|0.16||Longitudinal Data Analysis (LDA) model with baseline Weighted TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.16|-0.17|0.953
73929859|NCT01857063|147389824|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0||||0.974|TWO_SIDED|95.0|-0.07|0.07||Longitudinal Data Analysis (LDA) model with baseline nasal congestion score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.07|-0.07|0.974
73970664|NCT03858634|147481215|SUPERIORITY||LS mean difference|17.7|STANDARD_ERROR_OF_MEAN|74.17||0.8268|TWO_SIDED|80.0|-103.77|139.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||139.17|-103.77|0.8268
73970665|NCT03858634|147481215|SUPERIORITY||LS mean difference|12.4|STANDARD_ERROR_OF_MEAN|14.63||0.4082|TWO_SIDED|80.0|-7.03|31.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||31.75|-7.03|0.4082
73970666|NCT03858634|147481215|SUPERIORITY||LS mean difference|-50.4|STANDARD_ERROR_OF_MEAN|58.86||0.4818|TWO_SIDED|80.0|-161.43|60.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||60.56|-161.43|0.4818
73970667|NCT03858634|147481215|SUPERIORITY||LS mean difference|-27.1|STANDARD_ERROR_OF_MEAN|13.93||0.0673|TWO_SIDED|80.0|-45.64|-8.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-8.58|-45.64|0.0673
74029644|NCT02086565|147613808|SUPERIORITY||Group differences in expected 12 month c|-0.09|||||TWO_SIDED|95.0|-0.24|0.06||||||||0.06|-0.24|
74029645|NCT02116972|147613824|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.0821|TWO_SIDED|95.0|-1.22|0.07|||Logitudinal mixed effects model|||The step-down testing procedure to control for multiplicity would be voided if the primary endpoint is not met and analyses proceeded for exploratory purposes.||0.07|-1.22|0.0821
74029646|NCT00784784|147613838|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.23||||0.25|TWO_SIDED|95.0|0.01|4.8|||Fisher Exact|||That in a year with mismatch between influenza vaccine antigen and infecting H3N2 strain, seasonal (10-13 weeks) antiviral prophylaxis in adults will provide better protection from symptomatic influenza infection than trivalent inactivated split virus influenza vaccine.||4.8|0.01|0.25
74029647|NCT01400971|147613839|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.54|0.92||||||Public insurance||0.92|0.54|
73862877|NCT01294163|147271695|NON_INFERIORITY_OR_EQUIVALENCE|Xenon was to be concluded non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference \[mean troponin I level (xenon) - mean troponin I level (sevoflurane)\] was below the prespecified margin of 0.63 ng/mL. Assuming a margin of 0.63, a same concentration of troponin I at 24 hours in the xenon and sevoflurane groups, a common standard deviation of 1.9 ng/mL and a one-sided type I error of 0.025, 164 patients per group were deemed necessary to demonstrate non-inferiority.|Mean Difference (Final Values)|-0.4||||0.02|TWO_SIDED|95.0|-1.27|0.47|||ANCOVA|Treatment difference and 95%CI assessed using ANCOVA with 24h troponin I as response, treatment group and pre-induction troponin I as covariates.||||0.47|-1.27|0.02
73862878|NCT01294163|147271704|NON_INFERIORITY_OR_EQUIVALENCE|It was to be concluded that xenon was non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference \[mean troponin I level (xenon) - mean troponin I level (sevoflurane)\] was below the margin of 0.15 ng/mL.|Mean Difference (Final Values)|-0.09||||0.0186|TWO_SIDED|95.0|-0.3|0.11|||ANCOVA|||As the residuals from the primary ANCOVA model were non-normal and skewed, the non-inferiority analysis was repeated using log-transformed blood troponin levels.||0.11|-0.30|0.0186
73862879|NCT00958217|147271705|SUPERIORITY_OR_OTHER||2nd order effects of time (2 slope|33.0|||<|0.05|TWO_SIDED|95.0||||P-values based on likelihood ratio tests for the significance of the first and second order trajectory parameters. Primary tests compared curvilinear trajectories of the two treatment groups.|Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.|Data analyses included comparison of mean scores and linear mixed effects models used to ascertain trajectories for depression symptoms.||||<.05
73929860|NCT01857063|147389825|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.182|TWO_SIDED|95.0|-0.06|0.01||Longitudinal Data Analysis (LDA) model with baseline nasal discharge score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.01|-0.06|0.182
73929861|NCT01857063|147389826|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.161|TWO_SIDED|95.0|-0.01|0.05||Longitudinal Data Analysis (LDA) model with baseline sneezing score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.05|-0.01|0.161
73929862|NCT00689481|147389842|SUPERIORITY_OR_OTHER|||||||0.016|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.016
73929863|NCT00689481|147389842|SUPERIORITY_OR_OTHER|||||||0.843|||||||Breslow-Day test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1||||0.843
73929864|NCT00689481|147389843|SUPERIORITY_OR_OTHER|||||||0.034|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.034
73929865|NCT00689481|147389844|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is significant based on the Holm stepwise closed testing procedure to control multiplicity for the key secondary analyses if primary analysis was significant.|Cochran-Mantel-Haenszel|Stratified by pooled center.||||||0.004
74029648|NCT01400971|147613839|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|1.5|2.46||||||Diabetes support service available||2.46|1.50|
74029649|NCT01400971|147613839|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.38|2.49||||||Baseline HbA1c \> 7.80 (reference:HbA1c≤7.80 median)||2.49|1.38|
73862880|NCT00958217|147271706|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|57.0|||<|0.05|TWO_SIDED|95.0|||||Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.|||||<.05
73929866|NCT00689481|147389845|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.052
73929867|NCT00689481|147389846|SUPERIORITY_OR_OTHER|||||||0.033|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.033
73929868|NCT00689481|147389847|SUPERIORITY_OR_OTHER|||||||0.859|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline||||0.859
73929869|NCT00689481|147389847|SUPERIORITY_OR_OTHER|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline||||0.015
73929870|NCT06034496|147389868|SUPERIORITY|||||||0.012||||||CES main effect|ANOVA|||||||.012
73929871|NCT06034496|147389868|SUPERIORITY|||||||0.33||||||Session main effect|ANOVA|||||||.33
73929872|NCT06034496|147389868|SUPERIORITY|||||||0.85||||||Session (baseline, follow-up) x CES|ANOVA|||||||.85
73929873|NCT06034496|147389869|SUPERIORITY|||||||0.6||||||CES main effect|ANOVA|||||||.6
73929874|NCT06034496|147389869|SUPERIORITY|||||||0.9||||||Session main effect|ANOVA|||||||.9
73929875|NCT06034496|147389869|SUPERIORITY|||||||0.05||||||CES x Session interaction|ANOVA|||||||.05
73929876|NCT06034496|147389870|SUPERIORITY|||||||0.26||||||CES main effect|ANOVA|||||||.26
73929877|NCT06034496|147389870|SUPERIORITY|||||||0.17||||||Session main effect|ANOVA|||||||.17
73929878|NCT06034496|147389870|SUPERIORITY|||||||0.73||||||CES x Session main effect|ANOVA|||||||.73
73929879|NCT06034496|147389871|SUPERIORITY|||||||0.18||||||CES main effect|ANOVA|||||||.18
73929880|NCT06034496|147389871|SUPERIORITY|||||||0||||||Time main effect|ANOVA|||||||.00
73929881|NCT06034496|147389871|SUPERIORITY|||||||0.53||||||CES main effect|ANOVA|||||||.53
73929882|NCT06034496|147389871|SUPERIORITY|||||||0.07||||||CES x Time interaction|ANOVA|||||||.07
73929883|NCT06034496|147389871|SUPERIORITY|||||||0.46||||||CES x Session|ANOVA|||||||.46
73929884|NCT06034496|147389871|SUPERIORITY|||||||0.01||||||Time x Session interaction|ANOVA|||||||.01
73929885|NCT06034496|147389871|SUPERIORITY|||||||0.29||||||CES x Time x Session interaction|ANOVA|||||||.29
73929886|NCT06034496|147389872|SUPERIORITY|||||||0.1||||||CES main effect|ANOVA|||||||.10
74029650|NCT01400971|147613839|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|1.15|2.07||||||Baseline HbA1c missing (reference:HbA1c≤7.80 median)||2.07|1.15|
73929887|NCT06034496|147389872|SUPERIORITY|||||||0||||||Time main effect|ANOVA|||||||.00
73929888|NCT06034496|147389872|SUPERIORITY|||||||0.81||||||Session main effect|ANOVA|||||||.81
73929889|NCT06034496|147389872|SUPERIORITY|||||||0.4||||||CES x Time interaction|ANOVA|||||||.40
73929890|NCT06034496|147389872|SUPERIORITY|||||||0.35||||||CES x Session interaction|ANOVA|||||||.35
73929891|NCT06034496|147389872|SUPERIORITY|||||||0||||||Time x Session interaction|ANOVA|||||||.00
73929892|NCT06034496|147389872|SUPERIORITY|||||||0.4||||||CES x Time x Session interaction|ANOVA|||||||.40
73929893|NCT06034496|147389873|SUPERIORITY|||||||0.23||||||STAI-T CES main effect|ANOVA|||||||.23
73929894|NCT06034496|147389873|SUPERIORITY|||||||0.45||||||STAI-T Session main effect|ANOVA|||||||.45
74029651|NCT01400971|147613839|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.13|1.88||||||Diabetes duration \> 11 years||1.88|1.13|
74029652|NCT01400971|147613839|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.97|1.0||||||Age (per year increase)||1.00|0.97|
74029653|NCT01400971|147613839|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|10.5|||||TWO_SIDED|95.0|3.3|33.41||||||Baseline insulin therapy: combination||33.41|3.30|
74029654|NCT01400971|147613839|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|5.71|||||TWO_SIDED|95.0|1.77|18.37||||||Baseline insulin therapy: prandial only||18.37|1.77|
73929895|NCT06034496|147389873|SUPERIORITY|||||||0.38||||||STAI-T CES x Session interaction|ANOVA|||||||.38
73929896|NCT06034496|147389873|SUPERIORITY|||||||0.4||||||STAI-S CES main effect|ANOVA|||||||.40
73929897|NCT06034496|147389873|SUPERIORITY|||||||0||||||STAI-S Time main effect|ANOVA|||||||.00
73929898|NCT06034496|147389873|SUPERIORITY|||||||0||||||STAI-S Session main effect|ANOVA|||||||.00
73929899|NCT06034496|147389873|SUPERIORITY|||||||0.2||||||STAI-S CES x Time interaction|ANOVA|||||||.20
73929900|NCT06034496|147389873|SUPERIORITY|||||||0.39||||||STAI-S CES x Session interaction|ANOVA|||||||.39
73929901|NCT06034496|147389873|SUPERIORITY|||||||0||||||STAI-S Session x Time interaction|ANOVA|||||||.00
73929902|NCT06034496|147389873|SUPERIORITY|||||||0.38||||||STAI-S CES x Time x Session interaction|ANOVA|||||||.38
73929903|NCT06034496|147389874|SUPERIORITY|||||||0.85||||||CES main effect|ANOVA|||||||.85
73929904|NCT06034496|147389874|SUPERIORITY|||||||0.69||||||Session main effect|ANOVA|||||||.69
73929905|NCT06034496|147389874|SUPERIORITY|||||||0.4||||||CES x Session interaction|ANOVA|||||||.4
73929906|NCT06034496|147389875|SUPERIORITY|||||||0.13||||||CES main effect|ANOVA|||||||.13
73929907|NCT06034496|147389875|SUPERIORITY|||||||0.26||||||Session main effect|ANOVA|||||||.26
73929908|NCT06034496|147389875|SUPERIORITY|||||||0.44||||||CES x Session interaction|ANOVA|||||||.44
73929909|NCT06034496|147389876|SUPERIORITY|||||||0.36||||||CES main effect|ANOVA|||||||.36
73929910|NCT06034496|147389876|SUPERIORITY|||||||0||||||Session main effect|ANOVA|||||||.00
73929911|NCT06034496|147389876|SUPERIORITY|||||||0.96||||||CES x Session interaction|ANOVA|||||||.96
73929912|NCT03277261|147389880|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.406|||<|0.0001|TWO_SIDED|95.0|0.268|0.615||GEE (Generalized Estimating Equation) model for the relapse count per participant with logarithmic link function, treatment, region, and baseline Expanded Disability Status Scale (EDSS) strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.615|0.268|<0.0001
73929913|NCT03277261|147389881|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.033|||<|0.0001|TWO_SIDED|95.0|0.019|0.058||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.058|0.019|<0.0001
73929914|NCT03277261|147389882|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.076|||<|0.0001|TWO_SIDED|95.0|0.056|0.104||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.104|0.056|<0.0001
73929915|NCT03277261|147389884|SUPERIORITY||Odds Ratio (Ublituximab/Teriflunomide)|5.442|||<|0.0001|TWO_SIDED|95.0|3.536|8.375||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Regression, Logistic|||||8.375|3.536|<0.0001
73929916|NCT03277261|147389885|SUPERIORITY||Odds Ratio (Ublituximab/Teriflunomide)|0.872|||=|0.4669|TWO_SIDED|95.0|0.603|1.261||Logistic regression model with treatment, region, baseline EDSS strata, and log-transformed baseline MRI counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Logistic Regression|||||1.261|0.603|=0.4669
73929917|NCT03277261|147389886|SUPERIORITY||Least squares mean difference|-0.072|||<|0.0001|TWO_SIDED|95.0|-0.107|-0.036||The model includes treatment, region, baseline EDSS strata, visit, treatment-by-visit interaction, and baseline volume (cube root transformed) as covariates and an unstructured covariance matrix.|Mixed Model Repeated Measures (MMRM)|||||-0.036|-0.107|<0.0001
73929918|NCT05944250|147389888|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
73929919|NCT05944250|147389892|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 1||||1
73929920|NCT05944250|147389892|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 2||||1
74029655|NCT01400971|147613839|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|4.16|||||TWO_SIDED|95.0|3.02|5.73||||||Baseline insulin therapy: pre-mixed only||5.73|3.02|
74029656|NCT01400971|147613839|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. IPC ranges from 1-5 with higher scores indicating more discrimination.|Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.39|0.65||||||Discrimination domain of the IPC||0.65|0.39|
73929921|NCT05944250|147389892|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 3||||1
73929922|NCT05944250|147389892|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 4||||0.15
73929923|NCT05944250|147389893|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 1||||1
74029657|NCT01400971|147613839|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.|Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.57|0.95||||||Diabetes Distress Scale total score \> 2||0.95|0.57|
74029658|NCT02099799|147613843|SUPERIORITY||Mean Difference (Final Values)|-12.0||||0.189|TWO_SIDED||||||Mixed Models Analysis|||||||0.189
74029659|NCT02099799|147613844|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.572|TWO_SIDED||||||Mixed Models Analysis|||||||0.572
73929924|NCT05944250|147389893|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 2||||1
73929925|NCT05944250|147389893|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 3||||0.59
74029660|NCT02099799|147613845|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.799|TWO_SIDED||||||Mixed Models Analysis|||||||0.799
74029661|NCT02099799|147613846|SUPERIORITY||Mean Difference (Final Values)|1312.0|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73929926|NCT05944250|147389893|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 4||||0.09
73929927|NCT03466411|147389935|SUPERIORITY||Least Square (LS) Mean Difference|124.2|||<|0.001|TWO_SIDED|95.0|89.8|158.7|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||158.7|89.8|<0.001
73929928|NCT03466411|147389935|SUPERIORITY||LS Mean Difference|102.7|||<|0.001|TWO_SIDED|95.0|68.5|136.9|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||136.9|68.5|<0.001
73929929|NCT03466411|147389935|SUPERIORITY||LS Mean Difference|108.7|||<|0.001|TWO_SIDED|95.0|73.9|143.5|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||143.5|73.9|<0.001
73929930|NCT03466411|147389936|SUPERIORITY||Adjusted treatment difference|38.1|||<|0.001|TWO_SIDED|95.0|27.3|48.9|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||48.9|27.3|<0.001
73929931|NCT03466411|147389936|SUPERIORITY||Adjusted treatment difference|42.8|||<|0.001|TWO_SIDED|95.0|31.6|53.9|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||53.9|31.6|<0.001
73929932|NCT03466411|147389937|SUPERIORITY||Adjusted treatment difference|33.7|||<|0.001|TWO_SIDED|95.0|24.1|43.2|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||43.2|24.1|<0.001
73929933|NCT03466411|147389937|SUPERIORITY||Adjusted treatment difference|32.9|||<|0.001|TWO_SIDED|95.0|23.5|42.4|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||42.4|23.5|<0.001
73929934|NCT03466411|147389938|SUPERIORITY||Adjusted treatment difference|34.2|||<|0.001|TWO_SIDED|95.0|23.2|45.3|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||45.3|23.2|<0.001
73929935|NCT03466411|147389938|SUPERIORITY||Adjusted treatment difference|35.0|||<|0.001|TWO_SIDED|95.0|23.5|46.5|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||46.5|23.5|<0.001
73929936|NCT03466411|147389939|SUPERIORITY||Adjusted treatment difference|27.9|||<|0.001|TWO_SIDED|95.0|18.7|37.1|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||37.1|18.7|<0.001
73929937|NCT03466411|147389939|SUPERIORITY||Adjusted treatment difference|30.8|||<|0.001|TWO_SIDED|95.0|21.3|40.3|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||40.3|21.3|<0.001
74029662|NCT02099799|147613847|SUPERIORITY|||||||0.2265|||||||t-test, 2 sided|||||||0.2265
74029663|NCT02099799|147613848|SUPERIORITY|||||||0.8897|||||||t-test, 2 sided|||||||0.8897
74029664|NCT03290300|147613849|OTHER||||||<|0.0001||||||The pre-specified threshold for statistical significance was p\<0.05.|ANOVA|Repeated measures ANOVA with multiple comparisons to baseline||||||<0.0001
74029665|NCT01899144|147613867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.6|STANDARD_ERROR_OF_MEAN|4.87|<|0.0001|TWO_SIDED|95.0|13.0|32.2|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||32.20|13.00|<0.0001
74088152|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0018|TWO_SIDED|95.0|1.39|4.24|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.24|1.39|0.0018
73862881|NCT00958217|147271707|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|0.43|||<|0.05|TWO_SIDED|95.0|||||Linear Mixed Effects Model|A logit link was used in this model.|We gauged sampling error with 95% confidence bands.|Analysis of substance use was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of substance use (any alcohol or drug use) on a particular day.||||<.05
73862882|NCT00958217|147271707|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|0.26|||<|0.05|TWO_SIDED||||||Linear Mixed Effects Model|A logit link was used in this model|We gauged sampling error with 95% confidence bands.|Second statistical analysis evaluates trajectories of heavy drinking (\<5 drinks on a given day) Analysis of heavy drinking was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of heavy drinking (5 or more drinks) on a particular day.||||<.05
73862883|NCT01307462|147271749|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based physical functioning score||||.81
73862884|NCT01307462|147271749|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-physical score||||.18
73862885|NCT01307462|147271749|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based bodily pain score||||.48
73862886|NCT01307462|147271749|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based general health score||||.26
73862887|NCT01307462|147271749|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based vitality score||||.23
73862888|NCT01307462|147271749|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based social functioning score||||.36
73862889|NCT01307462|147271749|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-emotional score||||.41
73862890|NCT01307462|147271749|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based mental health score||||.80
73862891|NCT01307462|147271749|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized physical component score||||.80
73862892|NCT01307462|147271749|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized mental component score||||.23
73862893|NCT01307462|147271750|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||FACT physical well-being||||0.28
73970668|NCT03858634|147481215|SUPERIORITY||LS mean difference|29.6|STANDARD_ERROR_OF_MEAN|82.15||0.7429|TWO_SIDED|80.0|-105.0|164.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||164.10|-105.00|0.7429
73970669|NCT03858634|147481215|SUPERIORITY||LS mean difference|21.8|STANDARD_ERROR_OF_MEAN|13.55||0.1227|TWO_SIDED|80.0|3.88|39.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||39.79|3.88|0.1227
73970670|NCT03858634|147481215|SUPERIORITY||LS mean difference|-47.5|STANDARD_ERROR_OF_MEAN|58.06||0.4996|TWO_SIDED|80.0|-156.95|62.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||62.02|-156.95|0.4996
73862894|NCT01307462|147271750|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||FACT social/family well-being||||0.1
73862895|NCT01307462|147271750|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||FACT emotional well-being||||0.63
73862896|NCT01307462|147271750|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||FACT functional well-being||||0.78
73862897|NCT01307462|147271750|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||FACT BMT subscale||||.84
73862898|NCT01307462|147271750|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||FACT trial outcome index||||.37
73862899|NCT01307462|147271750|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||FACT-G||||.71
73862900|NCT01307462|147271750|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||FACT-BMT total||||.54
73862901|NCT01307462|147271751|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||HAP maximum activity score - highest item still doing||||.37
73862902|NCT01307462|147271751|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||HAP adjusted activity score - MAS minus stopped||||.39
73862903|NCT01307462|147271751|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Modified HAP adjusted activity score||||.39
73862904|NCT01307462|147271752|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Lee symptom skin scale||||.11
73862905|NCT01307462|147271752|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Lee symptom energy scale||||.007
73862906|NCT01307462|147271752|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Lee symptom lung scale||||.20
73862907|NCT01307462|147271752|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom eye scale||||.002
73862908|NCT01307462|147271752|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Lee symptom nutrition scale||||.52
73862909|NCT01307462|147271752|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Lee symptom psychological scale||||.22
73862910|NCT01307462|147271752|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom mouth scale||||.002
73862911|NCT01307462|147271752|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Lee symptom overall summary scale||||<0.001
73970671|NCT03858634|147481215|SUPERIORITY||LS mean difference|-33.6|STANDARD_ERROR_OF_MEAN|13.69||0.0244|TWO_SIDED|80.0|-51.87|-15.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-15.43|-51.87|0.0244
73970672|NCT03858634|147481215|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|64.24||0.9967|TWO_SIDED|80.0|-105.5|104.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||104.92|-105.50|0.9967
73970673|NCT03858634|147481215|SUPERIORITY||LS mean difference|19.1|STANDARD_ERROR_OF_MEAN|13.57||0.1739|TWO_SIDED|80.0|1.15|37.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||37.12|1.15|0.1739
73970674|NCT03858634|147481215|SUPERIORITY||LS mean difference|-55.1|STANDARD_ERROR_OF_MEAN|51.61||0.3978|TWO_SIDED|80.0|-152.39|42.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||42.26|-152.39|0.3978
73970675|NCT03858634|147481215|SUPERIORITY||LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|14.73||0.0397|TWO_SIDED|80.0|-52.26|-13.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.07|-52.26|0.0397
73970676|NCT03858634|147481215|SUPERIORITY||LS mean difference|10.4|STANDARD_ERROR_OF_MEAN|70.66||0.8922|TWO_SIDED|80.0|-105.32|126.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||126.14|-105.32|0.8922
74029666|NCT01899144|147613867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.2|STANDARD_ERROR_OF_MEAN|4.87|<|0.0001|TWO_SIDED|95.0|11.6|30.81|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||30.81|11.6|<0.0001
73929938|NCT03466411|147389940|SUPERIORITY||Adjusted treatment difference|25.1|||<|0.001|TWO_SIDED|95.0|14.1|36.2|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||36.2|14.1|<0.001
74029667|NCT01899144|147613867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.7|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|14.13|33.23|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||33.23|14.13|<0.0001
73929939|NCT03466411|147389941|SUPERIORITY||Adjusted treatment difference|27.7|||<|0.001|TWO_SIDED|95.0|19.3|36.1|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||36.1|19.3|<0.001
73929940|NCT03466411|147389942|SUPERIORITY||Adjusted treatment difference|31.2|||<|0.001|TWO_SIDED|95.0|21.1|41.3|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||41.3|21.1|<0.001
73929941|NCT03466411|147389943|SUPERIORITY||Adjusted treatment difference|22.1|||<|0.001|TWO_SIDED|95.0|12.2|31.9|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||31.9|12.2|<0.001
73929942|NCT04115358|147389979|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929943|NCT04115358|147389980|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929944|NCT04115358|147389981|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
74029668|NCT01899144|147613867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|4.85||0.0107|TWO_SIDED|95.0|2.93|22.05|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||22.05|2.93|0.0107
73929945|NCT04115358|147389982|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929946|NCT04115358|147389983|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929947|NCT04115358|147389984|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929948|NCT04115358|147389985|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929949|NCT04115358|147389986|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929950|NCT04115358|147389987|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929951|NCT04115358|147389988|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929952|NCT04115358|147389989|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929953|NCT04115358|147389990|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929954|NCT04115358|147389991|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929955|NCT04115358|147389992|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929956|NCT04115358|147389993|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
74029669|NCT01899144|147613867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|4.88||0.7772|TWO_SIDED|95.0|-11.0|8.23||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||8.23|-11.00|0.7772
73929957|NCT04115358|147389994|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
74088153|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|4.1||||0.015|TWO_SIDED|95.0|1.31|12.79|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||12.79|1.31|0.0150
73929958|NCT04115358|147389995|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929959|NCT04115358|147389996|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929960|NCT04115358|147389997|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929961|NCT04115358|147389998|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929962|NCT04115358|147389999|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929963|NCT04115358|147390000|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73970677|NCT03858634|147481215|SUPERIORITY||LS mean difference|17.3|STANDARD_ERROR_OF_MEAN|14.43||0.2439|TWO_SIDED|80.0|-1.8|36.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||36.45|-1.80|0.2439
73970678|NCT03858634|147481215|SUPERIORITY||LS mean difference|-50.3|STANDARD_ERROR_OF_MEAN|37.1||0.3076|TWO_SIDED|80.0|-120.29|19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||19.61|-120.29|0.3076
73970679|NCT03858634|147481215|SUPERIORITY||LS mean difference|-36.4|STANDARD_ERROR_OF_MEAN|15.7||0.0322|TWO_SIDED|80.0|-57.32|-15.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-15.55|-57.32|0.0322
73970680|NCT03858634|147481215|SUPERIORITY||LS mean difference|-94.7|STANDARD_ERROR_OF_MEAN|27.67||0.0418|TWO_SIDED|80.0|-139.98|-49.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-49.36|-139.98|0.0418
73929964|NCT04115358|147390001|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929965|NCT04115358|147390002|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929966|NCT04115358|147390003|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929967|NCT04115358|147390004|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929968|NCT04115358|147390005|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929969|NCT04115358|147390006|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929970|NCT04115358|147390007|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929971|NCT04115358|147390008|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929972|NCT04115358|147390009|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929973|NCT04115358|147390010|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
73929974|NCT02346240|147390021|SUPERIORITY||Estimated difference in responder rate|61.6|||||TWO_SIDED|95.0|52.1|71.2|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||71.2|52.1|
73970681|NCT03858634|147481215|SUPERIORITY||LS mean difference|24.4|STANDARD_ERROR_OF_MEAN|13.44||0.0865|TWO_SIDED|80.0|6.49|42.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||42.26|6.49|0.0865
73970682|NCT03858634|147481215|SUPERIORITY||LS mean difference|-48.9|STANDARD_ERROR_OF_MEAN|40.32||0.3489|TWO_SIDED|80.0|-124.96|27.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||27.11|-124.96|0.3489
73970683|NCT03858634|147481215|SUPERIORITY||LS mean difference|-38.1|STANDARD_ERROR_OF_MEAN|15.99||0.0286|TWO_SIDED|80.0|-59.34|-16.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-16.79|-59.34|0.0286
73970684|NCT03858634|147481215|SUPERIORITY||LS mean difference|28.6|STANDARD_ERROR_OF_MEAN|72.63||0.7198|TWO_SIDED|80.0|-90.32|147.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||147.59|-90.32|0.7198
73970685|NCT03858634|147481215|SUPERIORITY||LS mean difference|39.0|STANDARD_ERROR_OF_MEAN|13.27||0.0088|TWO_SIDED|80.0|21.32|56.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||56.63|21.32|0.0088
73970686|NCT03858634|147481215|SUPERIORITY||LS mean difference|-56.5|STANDARD_ERROR_OF_MEAN|33.87||0.2371|TWO_SIDED|80.0|-120.39|7.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||7.34|-120.39|0.2371
73970687|NCT03858634|147481215|SUPERIORITY||LS mean difference|-40.8|STANDARD_ERROR_OF_MEAN|16.14||0.021|TWO_SIDED|80.0|-62.3|-19.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-19.35|-62.30|0.0210
73929975|NCT02346240|147390021|SUPERIORITY||Estimated difference in responder rate|56.2|||||TWO_SIDED|95.0|46.4|66.0|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||66.0|46.4|
73929976|NCT02346240|147390021|SUPERIORITY||Odds Ratio (OR)|37.988|||<|0.0001|TWO_SIDED|95.0|11.312|127.576||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||127.576|11.312|<0.0001
73929977|NCT02346240|147390021|SUPERIORITY||Odds Ratio (OR)|30.023|||<|0.0001|TWO_SIDED|95.0|8.971|100.481||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||100.481|8.971|<0.0001
73929978|NCT02346240|147390021|SUPERIORITY||Estimated difference in responder rate|13.4|||||TWO_SIDED|95.0|2.7|24.1|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||24.1|2.7|
73929979|NCT02346240|147390021|SUPERIORITY||Estimated difference in responder rate|8.0|||||TWO_SIDED|95.0|-2.9|18.9|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||18.9|-2.9|
73929980|NCT02346240|147390021|SUPERIORITY||Odds Ratio (OR)|1.756|||=|0.0152|TWO_SIDED|95.0|1.114|2.768||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. ETN.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||2.768|1.114|=0.0152
73929981|NCT02346240|147390021|SUPERIORITY||Odds Ratio (OR)|1.388|||=|0.1523|TWO_SIDED|95.0|0.886|2.175||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. ETN|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||2.175|0.886|=0.1523
73929982|NCT02346240|147390022|SUPERIORITY||Estimated difference in responder rate|48.5|||||TWO_SIDED|95.0|39.33|57.63|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||57.63|39.33|
73929983|NCT02346240|147390022|SUPERIORITY||Estimated difference in responder rate|37.9|||||TWO_SIDED|95.0|28.88|46.96|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||46.96|28.88|
73929984|NCT02346240|147390022|SUPERIORITY||Odds Ratio (OR)|56.129|||<|0.0001|TWO_SIDED|95.0|7.787|404.555||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||404.555|7.787|<0.0001
73970688|NCT03858634|147481215|SUPERIORITY||LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|54.07||0.7312|TWO_SIDED|80.0|-68.17|108.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||108.94|-68.17|0.7312
74088154|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0211|TWO_SIDED|95.0|1.22|11.78|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||11.78|1.22|0.0211
73929985|NCT02346240|147390022|SUPERIORITY||Odds Ratio (OR)|36.566|||=|0.0004|TWO_SIDED|95.0|5.061|264.196||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||264.196|5.061|=0.0004
73929986|NCT02346240|147390023|SUPERIORITY||Estimated difference in responder rate|33.8|||||TWO_SIDED|95.0|20.68|46.98|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||46.98|20.68|
73862912|NCT04253587|147271765|EQUIVALENCE|The null hypothesis was no difference between mean change scores for time-points X conditions.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03|=|0.016|TWO_SIDED|95.0|-0.06|0.06||Mixed effects ANOVA applied family wise error for post-hoc tests according to a priori hypothesis|ANOVA|||||0.06|-0.06|= 0.016
73862913|NCT04253587|147271766|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.035|=|0.22|TWO_SIDED|95.0|-0.03|0.03|||ANOVA|effect of condition (F1,20 = 1.616, p = 0.22), effect of time (F1,20 = 0.613, p = 0.44)||||0.03|-0.03|= 0.22
73862914|NCT05501795|147271811|OTHER||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|5.8|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
73862915|NCT04243330|147271821|SUPERIORITY||Mean Difference (Net)|1.01||||0.18|TWO_SIDED|95.0|-0.46|2.48||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||2.48|-0.46|0.18
73862916|NCT04243330|147271822|SUPERIORITY||Mean Difference (Net)|3.58||||0.06|TWO_SIDED|95.0|-0.11|7.28||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||7.28|-0.11|.06
73862917|NCT04243330|147271823|SUPERIORITY||Median Difference (Net)|1.7||||0.6|TWO_SIDED|95.0|-4.5|7.9||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||7.9|-4.5|0.60
73862918|NCT04243330|147271824|SUPERIORITY||Median Difference (Net)|-4.1||||0.36|TWO_SIDED|95.0|-12.8|4.7||p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||4.7|-12.8|0.36
73862919|NCT04243330|147271825|SUPERIORITY||Mean Difference (Net)|-4.5||||0.02|TWO_SIDED|95.0|-8.3|-0.67||p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||-0.67|-8.3|.02
73862920|NCT04243330|147271826|SUPERIORITY||Mean Difference (Net)|-0.56||||0.82|TWO_SIDED|95.0|-5.5|4.4|||Mixed Models Analysis|||||4.4|-5.5|0.82
73862921|NCT02753127|147271836|SUPERIORITY||Hazard Ratio (HR)|0.976||||0.3629|TWO_SIDED|95.0|0.854|1.117||1-sided|Log Rank|Based on stratified log-rank test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment.|"Based on Cox Proportional hazards model stratified by actual stratification factors including Time to progression on 1st line therapy, RAS mutation, and Bev as part of study treatment.~A HR \<1 indicates a lower risk with Arm 1 compared with Arm 2."|General population||1.117|0.854|0.3629
73929987|NCT02346240|147390023|SUPERIORITY||Estimated difference in responder rate|31.0|||||TWO_SIDED|95.0|18.18|43.8|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||43.80|18.18|
73862922|NCT02753127|147271836|SUPERIORITY||Hazard Ratio (HR)|0.969||||0.3782|TWO_SIDED|95.0|0.797|1.179||1-sided|Log Rank|Based on unstratified log-rank test. P-value is nominal p value without multiplicity adjustment.|Hazard Ratio is for Napabucasin + FOLFIRI ± bev vs FOLFIRI ± bev. Based on unstratified Cox proportional hazards model. A hazard ratio \<1 indicates a lower risk with Napabucasin+ FOLFIRI ± bev compared with FOLFIRI ± bev.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||1.179|0.797|0.3782
73862923|NCT02753127|147271837|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7307|TWO_SIDED|95.0|0.917|1.18||1-sided|Log Rank|"Based on stratified log rank test stratified by actual stratification factors~. P-value is nominal p-value without multiplicity adjustment."|"Based on Cox Proportional hazards model stratified by actual stratification~. A HR \<1 indicates a lower risk with Arm 1 compared with Arm 2."|General population||1.180|0.917|0.7307
73929988|NCT02346240|147390023|SUPERIORITY||Odds Ratio (OR)|39.949|||<|0.0001|TWO_SIDED|95.0|8.407|189.828||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||189.828|8.407|<0.0001
73929989|NCT02346240|147390023|SUPERIORITY||Odds Ratio (OR)|35.084|||<|0.0001|TWO_SIDED|95.0|7.363|167.179||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||167.179|7.363|<0.0001
73970689|NCT03858634|147481215|SUPERIORITY||LS mean difference|39.4|STANDARD_ERROR_OF_MEAN|14.64||0.015|TWO_SIDED|80.0|19.88|58.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||58.83|19.88|0.0150
73862924|NCT02753127|147271837|SUPERIORITY||Hazard Ratio (HR)|1.064||||0.7434|TWO_SIDED|95.0|0.883|1.283||1-sided|Log Rank|Based on unstratified log-rank test. P-value is nominal p-value without multiplicity adjustment.|Hazard ratio is for Napabucasin + FOLFIRI ± bev vs FOLFIRI ± bev. Based on unstratified Cox Proportional hazards model. A hazard ratio \<1 indicates a lower risk with Napabucasin + FOLFIRI ± bev compared with FOLFIRI ± bev.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||1.283|0.883|0.7434
73929990|NCT02346240|147390024|SUPERIORITY||Estimated difference in responder rate|70.9|||||TWO_SIDED|95.0|62.15|79.59|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||79.59|62.15|
73970690|NCT03858634|147481215|SUPERIORITY||LS mean difference|-53.3|STANDARD_ERROR_OF_MEAN|33.87||0.2559|TWO_SIDED|80.0|-117.22|10.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||10.52|-117.22|0.2559
73970691|NCT03858634|147481215|SUPERIORITY||LS mean difference|-35.0|STANDARD_ERROR_OF_MEAN|15.97||0.0419|TWO_SIDED|80.0|-56.21|-13.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-13.72|-56.21|0.0419
73970692|NCT03858634|147481215|SUPERIORITY||LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|60.66||0.7589|TWO_SIDED|80.0|-78.95|119.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||119.74|-78.95|0.7589
73970693|NCT03858634|147481215|SUPERIORITY||LS mean difference|39.1|STANDARD_ERROR_OF_MEAN|17.42||0.0374|TWO_SIDED|80.0|15.97|62.31||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||62.31|15.97|0.0374
73970694|NCT03858634|147481215|SUPERIORITY||LS mean difference|-54.9|STANDARD_ERROR_OF_MEAN|33.87||0.2463|TWO_SIDED|80.0|-118.8|8.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||8.93|-118.80|0.2463
73970695|NCT03858634|147481215|SUPERIORITY||LS mean difference|-33.2|STANDARD_ERROR_OF_MEAN|16.78||0.0632|TWO_SIDED|80.0|-55.56|-10.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-10.90|-55.56|0.0632
73970696|NCT03858634|147481215|SUPERIORITY||LS mean difference|25.7|STANDARD_ERROR_OF_MEAN|61.73||0.7053|TWO_SIDED|80.0|-75.41|126.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||126.78|-75.41|0.7053
73970697|NCT03858634|147481215|SUPERIORITY||LS mean difference|38.7|STANDARD_ERROR_OF_MEAN|16.25||0.0285|TWO_SIDED|80.0|17.09|60.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||60.34|17.09|0.0285
73970698|NCT03858634|147481215|SUPERIORITY||LS mean difference|-64.6|STANDARD_ERROR_OF_MEAN|37.1||0.2236|TWO_SIDED|80.0|-134.58|5.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||5.32|-134.58|0.2236
73970699|NCT03858634|147481215|OTHER||LS mean difference|-35.5|STANDARD_ERROR_OF_MEAN|17.38||0.0558|TWO_SIDED|80.0|-58.65|-12.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-12.41|-58.65|0.0558
73970700|NCT03858634|147481215|SUPERIORITY||LS mean difference|29.9|STANDARD_ERROR_OF_MEAN|72.86||0.7089|TWO_SIDED|80.0|-89.41|149.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||149.24|-89.41|0.7089
74029670|NCT01899144|147613867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|4.87||0.0226|TWO_SIDED|95.0|-20.8|-1.59||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||-1.59|-20.80|0.0226
74029671|NCT01899144|147613868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.64|0.26|<0.0001
73970701|NCT03858634|147481215|SUPERIORITY||LS mean difference|33.7|STANDARD_ERROR_OF_MEAN|14.76||0.0347|TWO_SIDED|80.0|14.08|53.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||53.35|14.08|0.0347
74088155|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.43|2.84|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.84|1.43|<.0001
73970702|NCT03858634|147481215|SUPERIORITY||LS mean difference|-60.9|STANDARD_ERROR_OF_MEAN|41.94||0.2835|TWO_SIDED|80.0|-139.99|18.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||18.16|-139.99|0.2835
73970703|NCT03858634|147481215|SUPERIORITY||LS mean difference|-35.5|STANDARD_ERROR_OF_MEAN|17.11||0.0525|TWO_SIDED|80.0|-58.31|-12.77||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-12.77|-58.31|0.0525
73970704|NCT03858634|147481215|SUPERIORITY||LS mean difference|24.0|STANDARD_ERROR_OF_MEAN|64.52||0.7347|TWO_SIDED|80.0|-81.68|129.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||129.66|-81.68|0.7347
73970705|NCT03858634|147481215|SUPERIORITY||LS mean difference|31.0|STANDARD_ERROR_OF_MEAN|13.94||0.039|TWO_SIDED|80.0|12.5|49.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||49.60|12.50|0.0390
73970706|NCT03858634|147481215|SUPERIORITY||LS mean difference|-60.6|STANDARD_ERROR_OF_MEAN|35.48||0.2299|TWO_SIDED|80.0|-127.49|6.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||6.33|-127.49|0.2299
73970707|NCT03858634|147481215|SUPERIORITY||LS mean difference|-32.6|STANDARD_ERROR_OF_MEAN|18.11||0.0884|TWO_SIDED|80.0|-56.7|-8.53||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-8.53|-56.70|0.0884
73970708|NCT03858634|147481215|SUPERIORITY||LS mean difference|16.3|STANDARD_ERROR_OF_MEAN|61.44||0.8085|TWO_SIDED|80.0|-84.37|116.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||116.87|-84.37|0.8085
73970709|NCT03858634|147481215|SUPERIORITY||LS mean difference|19.9|STANDARD_ERROR_OF_MEAN|15.96||0.2283|TWO_SIDED|80.0|-1.33|41.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||41.14|-1.33|0.2283
73970710|NCT03858634|147481215|SUPERIORITY||LS mean difference|-69.9|STANDARD_ERROR_OF_MEAN|32.26||0.1625|TWO_SIDED|80.0|-130.76|-9.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-9.11|-130.76|0.1625
73970711|NCT03858634|147481215|SUPERIORITY||LS mean difference|-34.2|STANDARD_ERROR_OF_MEAN|17.8||0.0707|TWO_SIDED|80.0|-57.87|-10.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-10.52|-57.87|0.0707
73862925|NCT02753127|147271838|SUPERIORITY||rate difference|0.1||||0.4797|TWO_SIDED|95.0|-4.9|5.2||1-sided|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment .|Treatment difference and 95% CI is based on Harmonic Means method adjusting stratification factor|General population||5.2|-4.9|0.4797
73862926|NCT02753127|147271838|SUPERIORITY||rate difference|-3.1||||0.783|TWO_SIDED|95.0|-11.0|4.7||1-sided|Z test|Based on one-sided Z test. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on normal approximation method.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||4.7|-11.0|0.783
73929991|NCT02346240|147390024|SUPERIORITY||Estimated difference in responder rate|64.4|||||TWO_SIDED|95.0|55.12|73.63|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||73.63|55.12|
73929992|NCT02346240|147390024|SUPERIORITY||Odds Ratio (OR)|76.277|||<|0.0001|TWO_SIDED|95.0|17.952|324.094||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||324.094|17.952|<0.0001
73929993|NCT02346240|147390024|SUPERIORITY||Odds Ratio (OR)|55.413|||<|0.0001|TWO_SIDED|95.0|13.135|233.782||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||233.782|13.135|<0.0001
73929994|NCT02346240|147390025|SUPERIORITY||Estimated difference in responder rate|55.0|||||TWO_SIDED|95.0|45.59|64.35|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||64.35|45.59|
73929995|NCT02346240|147390025|SUPERIORITY||Estimated difference in responder rate|44.9|||||TWO_SIDED|95.0|35.39|54.49|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||54.49|35.39|
73970712|NCT03858634|147481215|SUPERIORITY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|50.17||0.9944|TWO_SIDED|80.0|-81.79|82.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||82.55|-81.79|0.9944
73970713|NCT03858634|147481215|SUPERIORITY||LS mean difference|23.9|STANDARD_ERROR_OF_MEAN|15.16||0.1327|TWO_SIDED|80.0|3.71|44.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||44.05|3.71|0.1327
73862927|NCT02753127|147271839|SUPERIORITY||rate difference|-0.9||||0.6776|TWO_SIDED|95.0|-4.8|3.0||1-sided|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on Harmonic Means method adjusting stratification factor|General population||3.0|-4.8|0.6776
73862928|NCT02753127|147271839|SUPERIORITY||rate difference|-2.0||||0.7513|TWO_SIDED|95.0|-7.7|3.7||1-sided|Z test|Based on one-sided Z test. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on normal approximation method.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||3.7|-7.7|0.7513
73862929|NCT01114360|147271881|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||ANOVA|Two-way repeated measures mixed model ANOVA.||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.||||0.075
73862930|NCT01114360|147271881|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||ANOVA|||||||0.75
73970714|NCT03858634|147481215|SUPERIORITY||LS mean difference|-69.2|STANDARD_ERROR_OF_MEAN|33.87||0.1777|TWO_SIDED|80.0|-133.09|-5.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-5.35|-133.09|0.1777
73862931|NCT01114360|147271882|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||||||0.79
73929996|NCT02346240|147390025|SUPERIORITY||Odds Ratio (OR)|40.717|||<|0.0001|TWO_SIDED|95.0|9.741|170.198||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||170.198|9.741|<0.0001
73970715|NCT03858634|147481215|SUPERIORITY||LS mean difference|-23.9|STANDARD_ERROR_OF_MEAN|21.4||0.2796|TWO_SIDED|80.0|-52.34|4.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||4.61|-52.34|0.2796
73970716|NCT03858634|147481215|SUPERIORITY||LS mean difference|7.6|STANDARD_ERROR_OF_MEAN|55.4||0.8999|TWO_SIDED|80.0|-83.15|98.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||98.30|-83.15|0.8999
73862932|NCT01114360|147271883|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||||||0.21
73862933|NCT01114360|147271884|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||ANOVA|||||||0.64
73862934|NCT01114360|147271885|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||ANOVA|||||||0.89
73862935|NCT01114360|147271886|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||||||0.97
73862936|NCT01114360|147271887|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
73970717|NCT03858634|147481215|SUPERIORITY||LS mean difference|22.0|STANDARD_ERROR_OF_MEAN|15.99||0.1867|TWO_SIDED|80.0|0.68|43.23||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||43.23|0.68|0.1867
73970718|NCT03858634|147481215|SUPERIORITY||LS mean difference|-70.8|STANDARD_ERROR_OF_MEAN|33.87||0.1717|TWO_SIDED|80.0|-134.68|-6.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-6.94|-134.68|0.1717
73970719|NCT03858634|147481215|SUPERIORITY||LS mean difference|-23.9|STANDARD_ERROR_OF_MEAN|21.46||0.2792|TWO_SIDED|80.0|-52.5|4.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||4.61|-52.50|0.2792
73970720|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|31.41||0.2289|TWO_SIDED|80.0|-98.77|4.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||4.10|-98.77|0.2289
73970721|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|19.6|STANDARD_ERROR_OF_MEAN|14.08||0.1788|TWO_SIDED|80.0|0.96|38.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||38.27|0.96|0.1788
73970722|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-59.6|STANDARD_ERROR_OF_MEAN|114.35||0.6544|TWO_SIDED|80.0|-275.19|156.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||156.06|-275.19|0.6544
73970723|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-72.2|STANDARD_ERROR_OF_MEAN|20.4||0.0023|TWO_SIDED|80.0|-99.39|-45.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-45.09|-99.39|0.0023
73970724|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-52.1|STANDARD_ERROR_OF_MEAN|22.96||0.1081|TWO_SIDED|80.0|-89.68|-14.47||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-14.47|-89.68|0.1081
74029672|NCT01899144|147613868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.21|0.59|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.59|0.21|<0.0001
74029673|NCT01899144|147613868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.64|0.26|<0.0001
73970725|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|21.37||0.4926|TWO_SIDED|80.0|-13.39|43.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||43.26|-13.39|0.4926
73970726|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|53.2|STANDARD_ERROR_OF_MEAN|219.98||0.8315|TWO_SIDED|80.0|-361.63|467.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||467.98|-361.63|0.8315
73970727|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-69.9|STANDARD_ERROR_OF_MEAN|18.56||0.0014|TWO_SIDED|80.0|-94.61|-45.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-45.22|-94.61|0.0014
73970728|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-52.1|STANDARD_ERROR_OF_MEAN|22.96||0.1081|TWO_SIDED|80.0|-89.68|-14.47||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-14.47|-89.68|0.1081
73970729|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|21.97||0.7339|TWO_SIDED|80.0|-21.65|36.82||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||36.82|-21.65|0.7339
73970730|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|53.2|STANDARD_ERROR_OF_MEAN|219.98||0.8315|TWO_SIDED|80.0|-361.63|467.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||467.98|-361.63|0.8315
73970731|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-67.6|STANDARD_ERROR_OF_MEAN|21.26||0.0055|TWO_SIDED|80.0|-95.92|-39.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-39.22|-95.92|0.0055
73970732|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-57.9|STANDARD_ERROR_OF_MEAN|26.73||0.1188|TWO_SIDED|80.0|-101.7|-14.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-14.15|-101.70|0.1188
73970733|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|18.27||0.8697|TWO_SIDED|80.0|-21.26|27.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||27.35|-21.26|0.8697
73970734|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-30.3|STANDARD_ERROR_OF_MEAN|78.64||0.7368|TWO_SIDED|80.0|-178.62|117.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||117.94|-178.62|0.7368
73970735|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|15.02||0.5571|TWO_SIDED|80.0|-29.03|11.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||11.03|-29.03|0.5571
73929997|NCT02346240|147390025|SUPERIORITY||Odds Ratio (OR)|27.165|||<|0.0001|TWO_SIDED|95.0|6.504|113.453||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||113.453|6.504|<0.0001
73929998|NCT02346240|147390026|SUPERIORITY||Estimated difference in responder rate|48.8|||||TWO_SIDED|95.0|34.22|63.41|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||63.41|34.22|
73929999|NCT02346240|147390026|SUPERIORITY||Estimated difference in responder rate|39.5|||||TWO_SIDED|95.0|25.58|53.38|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||53.38|25.58|
73930000|NCT02346240|147390026|SUPERIORITY||Odds Ratio (OR)|72.278|||<|0.0001|TWO_SIDED|95.0|14.65|356.602||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||356.602|14.650|<0.0001
73930001|NCT02346240|147390026|SUPERIORITY||Odds Ratio (OR)|49.527|||<|0.0001|TWO_SIDED|95.0|10.002|245.256||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||245.256|10.002|<0.0001
73930002|NCT01573624|147390030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.264|TWO_SIDED|95.0|-0.019|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.071|-0.019|0.264
73930003|NCT01573624|147390030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033||||0.165|TWO_SIDED|95.0|-0.013|0.079|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.079|-0.013|0.165
73930004|NCT01573624|147390030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.271|TWO_SIDED|95.0|-0.02|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.071|-0.020|0.271
73930005|NCT01573624|147390030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.018|TWO_SIDED|95.0|0.01|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.100|0.010|0.018
73930006|NCT01573624|147390030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.018|TWO_SIDED|95.0|0.01|0.101|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.101|0.010|0.018
73930007|NCT01573624|147390030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.078|||<|0.001|TWO_SIDED|95.0|0.032|0.124|||Mixed Models Analysis|||||0.124|0.032|<0.001
73930008|NCT01573624|147390030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.052||||0.023|TWO_SIDED|95.0|-0.097|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-0.007|-0.097|0.023
73930009|NCT01573624|147390030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045||||0.051|TWO_SIDED|95.0|-0.091|0.0|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.000|-0.091|0.051
73930010|NCT01573624|147390030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.053||||0.023|TWO_SIDED|95.0|-0.098|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-0.007|-0.098|0.023
73970736|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-49.1|STANDARD_ERROR_OF_MEAN|32.21||0.2251|TWO_SIDED|80.0|-101.8|3.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||3.69|-101.80|0.2251
73970737|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|18.93||0.3733|TWO_SIDED|80.0|-7.9|42.48||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||42.48|-7.90|0.3733
73970738|NCT03858634|147481217|SUPERIORITY||LS Mean Difference|-22.6|STANDARD_ERROR_OF_MEAN|66.57||0.7662|TWO_SIDED|80.0|-148.16|102.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||102.89|-148.16|0.7662
73970739|NCT03858634|147481217|OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|16.87||0.7241|TWO_SIDED|80.0|-28.54|16.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||16.44|-28.54|0.7241
73970740|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-21.1|STANDARD_ERROR_OF_MEAN|29.04||0.5195|TWO_SIDED|80.0|-68.69|26.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||26.43|-68.69|0.5195
74088156|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.19|||<|0.0001|TWO_SIDED|95.0|1.55|3.1|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.55|<.0001
74088157|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.47|3.0|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.00|1.47|<.0001
73970741|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|11.3|STANDARD_ERROR_OF_MEAN|8.27||0.1869|TWO_SIDED|80.0|0.34|22.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||22.26|0.34|0.1869
73970742|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-87.5|STANDARD_ERROR_OF_MEAN|55.3||0.2545|TWO_SIDED|80.0|-191.75|16.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||16.79|-191.75|0.2545
73970743|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|10.26||0.0643|TWO_SIDED|80.0|-33.88|-6.57||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.57|-33.88|0.0643
73970744|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-28.6|STANDARD_ERROR_OF_MEAN|20.11||0.2503|TWO_SIDED|80.0|-61.52|4.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||4.35|-61.52|0.2503
73970745|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|11.58||0.8468|TWO_SIDED|80.0|-13.08|17.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||17.62|-13.08|0.8468
73970746|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-83.6|STANDARD_ERROR_OF_MEAN|73.93||0.3755|TWO_SIDED|80.0|-222.98|55.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||55.18|-222.98|0.3755
73862937|NCT01114360|147271888|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||ANOVA|||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.||||0.75
73970747|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-20.9|STANDARD_ERROR_OF_MEAN|11.06||0.0755|TWO_SIDED|80.0|-35.58|-6.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-6.15|-35.58|0.0755
73970748|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-28.6|STANDARD_ERROR_OF_MEAN|25.77||0.3486|TWO_SIDED|80.0|-70.76|13.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||13.65|-70.76|0.3486
73970749|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|9.69||0.6559|TWO_SIDED|80.0|-17.28|8.5||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||8.50|-17.28|0.6559
73970750|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-70.2|STANDARD_ERROR_OF_MEAN|50.46||0.2987|TWO_SIDED|80.0|-165.35|24.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||24.94|-165.35|0.2987
73970751|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|12.43||0.1966|TWO_SIDED|80.0|-33.29|-0.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-0.13|-33.29|0.1966
73970752|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-41.5|STANDARD_ERROR_OF_MEAN|25.7||0.2051|TWO_SIDED|80.0|-83.56|0.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||0.62|-83.56|0.2051
73970753|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|10.16||0.7511|TWO_SIDED|80.0|-16.79|10.25||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||10.25|-16.79|0.7511
73970754|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-79.6|STANDARD_DEVIATION|39.27||0.1797|TWO_SIDED|80.0|-153.68|-5.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-5.59|-153.68|0.1797
73970755|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|11.45||0.1715|TWO_SIDED|80.0|-31.61|-1.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-1.08|-31.61|0.1715
73970756|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-36.5|STANDARD_ERROR_OF_MEAN|21.32||0.185|TWO_SIDED|80.0|-71.47|-1.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-1.63|-71.47|0.1850
73970757|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|12.19||0.6907|TWO_SIDED|80.0|-21.15|11.29||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||11.29|-21.15|0.6907
73930011|NCT01573624|147390030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023||||0.306|TWO_SIDED|95.0|-0.068|0.021|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.021|-0.068|0.306
73930012|NCT01573624|147390030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.023||||0.33|TWO_SIDED|95.0|-0.068|0.023|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.023|-0.068|0.330
73930013|NCT01573624|147390031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.9|||<|0.001|TWO_SIDED|95.0|9.5|22.3|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||22.3|9.5|<0.001
73930014|NCT01573624|147390031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.4|||<|0.001|TWO_SIDED|95.0|10.9|23.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||23.9|10.9|<0.001
73930015|NCT01573624|147390031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|||<|0.001|TWO_SIDED|95.0|12.1|25.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||25.1|12.1|<0.001
73970758|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-74.0|STANDARD_ERROR_OF_MEAN|23.85||0.0901|TWO_SIDED|80.0|-118.97|-29.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-29.02|-118.97|0.0901
73970759|NCT03858634|147481219|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|13.34||0.564|TWO_SIDED|80.0|-25.64|9.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||9.94|-25.64|0.5640
74088158|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.08|||<|0.0001|TWO_SIDED|95.0|1.46|2.96|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.46|<.0001
74088159|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.74||||0.018|TWO_SIDED|95.0|1.1|2.76|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.76|1.10|0.0180
73930016|NCT01573624|147390031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9|||<|0.001|TWO_SIDED|95.0|16.5|29.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||29.4|16.5|<0.001
73930017|NCT01573624|147390031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.0|||<|0.001|TWO_SIDED|95.0|15.5|28.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||28.4|15.5|<0.001
73930018|NCT01573624|147390031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.0|||<|0.001|TWO_SIDED|95.0|20.6|33.5|||Mixed Models Analysis|||||33.5|20.6|<0.001
73930019|NCT01573624|147390031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-17.6|-4.7|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-4.7|-17.6|<0.001
73930020|NCT01573624|147390031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.6||||0.004|TWO_SIDED|95.0|-16.1|-3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-3.1|-16.1|0.004
73930021|NCT01573624|147390031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.4||||0.012|TWO_SIDED|95.0|-14.9|-1.9|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-1.9|-14.9|0.012
73970760|NCT03858634|147481220|SUPERIORITY||LS mean difference|-31.7|STANDARD_ERROR_OF_MEAN|38.73||0.4734|TWO_SIDED|80.0|-95.11|31.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||31.76|-95.11|0.4734
73970761|NCT03858634|147481220|SUPERIORITY||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|14.91||0.813|TWO_SIDED|80.0|-23.33|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||16.18|-23.33|0.8130
73970762|NCT03858634|147481220|SUPERIORITY||LS mean difference|-92.0|STANDARD_ERROR_OF_MEAN|31.1||0.0979|TWO_SIDED|80.0|-150.6|-33.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-33.32|-150.60|0.0979
73970763|NCT03858634|147481220|SUPERIORITY||LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|13.48||0.0122|TWO_SIDED|80.0|-55.48|-19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-19.61|-55.48|0.0122
73970764|NCT03150173|147481267|SUPERIORITY|||||||0.94|||||||Chi-squared|||||||0.94
74088160|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0072|TWO_SIDED|95.0|1.18|2.94|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.94|1.18|0.0072
73862938|NCT01114360|147271889|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Friedman|||||||0.71
73930022|NCT01573624|147390031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.209|TWO_SIDED|95.0|-10.6|2.3|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||2.3|-10.6|0.209
73930023|NCT01573624|147390031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1||||0.124|TWO_SIDED|95.0|-11.6|1.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||1.4|-11.6|0.124
73930024|NCT01573624|147390032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.2|||<|0.001|TWO_SIDED|95.0|9.5|22.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||22.9|9.5|<0.001
73930025|NCT01573624|147390032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.2|||<|0.001|TWO_SIDED|95.0|10.5|24.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||24.0|10.5|<0.001
73930026|NCT01573624|147390032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.2|||<|0.001|TWO_SIDED|95.0|14.4|28.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||28.0|14.4|<0.001
73930027|NCT01573624|147390032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.8|||<|0.001|TWO_SIDED|95.0|22.1|35.5|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||35.5|22.1|<0.001
73930028|NCT01573624|147390032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9|||<|0.001|TWO_SIDED|95.0|16.2|29.6|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||29.6|16.2|<0.001
73970765|NCT05530603|147481288|OTHER|||||||0.009||||||The threshold for statistical significance was p=0.05.|Chi-squared|||||||.009
73930029|NCT01573624|147390032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.6|||<|0.001|TWO_SIDED|95.0|19.8|33.4|||Mixed Models Analysis|||||33.4|19.8|<0.001
73970766|NCT05530603|147481289|OTHER||Mean Difference (Net)|1.12|STANDARD_DEVIATION|0.8||0.73|TWO_SIDED|||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.730
73970767|NCT05530603|147481290|OTHER|||||||0.033||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||.033
73970768|NCT05530603|147481291|OTHER|||||||0.068|||||||ANOVA|The threshold for statistical significance was p=0.05.||||||.068
73930030|NCT01573624|147390032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3||||0.003|TWO_SIDED|95.0|-17.2|-3.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-3.5|-17.2|0.003
73930031|NCT01573624|147390032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.3||||0.007|TWO_SIDED|95.0|-16.2|-2.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-2.5|-16.2|0.007
73930032|NCT01573624|147390032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.4||||0.126|TWO_SIDED|95.0|-12.3|1.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||1.5|-12.3|0.126
73930033|NCT01573624|147390032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2||||0.523||95.0|-4.6|9.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||9.1|-4.6|0.523
73930034|NCT01573624|147390032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7||||0.29|TWO_SIDED|95.0|-10.5|3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||3.1|-10.5|0.290
73970769|NCT05530603|147481292|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|Fisher Exact|||||||.001
73970770|NCT05530603|147481293|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||.001
73970771|NCT05530603|147481294|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||.001
73970772|NCT05448105|147481337|SUPERIORITY|||||||0.02|||||||Wilcoxon signed rank test|"Wilcoxon signed rank test comparing the participants' SUS scores to the threshold value of 71 indicative of good usability."||||||0.02
73970773|NCT05448105|147481340|OTHER|||||||0.04|||||||paired Wilcoxon signed-rank sum test|||||||0.04
73970774|NCT05448105|147481341|OTHER||||||<|0.01||||||This is calculated p-value. The threshold for significance was less than 0.05.|paired Wilcoxon signed-rank sum test|||||||<0.01
73970775|NCT05448105|147481342|OTHER|||||||0.16|||||||paired Wilcoxon signed-rank sum test|||||||0.16
73862939|NCT01114360|147271890|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Friedman|||||||0.38
73862940|NCT01114360|147271891|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Friedman|||||||0.11
73930035|NCT01573624|147390033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.036|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.036
73930036|NCT01573624|147390033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.064|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.064
73930037|NCT01573624|147390033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.335|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.1|-0.3|0.335
73930038|NCT01573624|147390033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.012|TWO_SIDED|95.0|-0.5|-0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||-0.1|-0.5|0.012
73930039|NCT01573624|147390033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.023|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.023
73930040|NCT01573624|147390033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||||-0.2|-0.7|<0.001
73970776|NCT05448105|147481343|OTHER|||||||0.69|||||||paired Wilcoxon signed-rank sum test|||||||0.69
74088161|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|10.84||||0.0015|TWO_SIDED|95.0|2.49|47.22|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||47.22|2.49|0.0015
74088162|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|8.62||||0.0044|TWO_SIDED|95.0|1.96|37.96|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||37.96|1.96|0.0044
74088163|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0018|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0018
73930041|NCT01573624|147390033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.104|TWO_SIDED|95.0|0.0|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|0.0|0.104
73930042|NCT01573624|147390033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.062|TWO_SIDED|95.0|0.0|0.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.5|0.0|0.062
73862941|NCT01114360|147271892|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANOVA|||||||0.96
73862942|NCT01114360|147271893|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
73930043|NCT01573624|147390033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.006|TWO_SIDED|95.0|0.1|0.6|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.6|0.1|0.006
73930044|NCT01573624|147390033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.217|TWO_SIDED|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|-0.1|0.217
73930045|NCT01573624|147390033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.143|TWO_SIDED|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|-0.1|0.143
73930046|NCT02115282|147390035|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.3|TWO_SIDED|95.0|0.67|1.13||The p value was based on stratified log rank test, the threshold for significance was two-sided p value of 0.2%.|Log Rank|||||1.13|0.67|0.30
73930047|NCT02115282|147390036|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.94|TWO_SIDED|95.0|0.82|1.21||The p value was based on stratified log rank test, stratified on the four randomization factors. The threshold for statistical significance was two-sided p value of 3.7% after taking into account the five interim analyses of OS into account.|Log Rank|||||1.21|0.82|0.94
73970777|NCT05448105|147481344|OTHER|||||||0.9|||||||paired Wilcoxon signed-rank sum test|||||||0.90
73970778|NCT05448105|147481345|OTHER|||||||0.11|||||||paired Wilcoxon signed-rank sum test|||||||0.11
73970779|NCT05448105|147481346|OTHER|||||||0.22|||||||paired Wilcoxon signed-rank sum test|||||||0.22
73970780|NCT05448105|147481347|OTHER|||||||1||||||This is the calculated p-value.|McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||1.00
73970781|NCT05448105|147481347|OTHER|||||||0.55|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||0.55
73862943|NCT01114360|147271894|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||ANOVA|||||||0.52
73930048|NCT06561217|147390077|NON_INFERIORITY|A predefined non-inferiority margin of 0.05 was used. The primary study was powered on a retrospective, paired, non-inferiority design to evaluate abstraction accuracy of elements commonly used to help screen patients for clinical trials.|Mean Difference (Final Values)|0.02|||<|0.001|ONE_SIDED|95.0|0.00007515||||Wilcoxon (Mann-Whitney)||The upper bound of the 95% confidence interval is Inf due to the test being one-sided. Alternative hypothesis: true median location shift is greater than -0.05|A Shapiro-Wilk test was used to assess normality of paired differences in chart-level accuracy (alpha = 0.05). A one-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test the primary null hypothesis of whether chart-level accuracy of the Human+AI arm for EHR chart abstraction was non-inferior to the chart-level accuracy of a Human-alone arm abstraction by at least 5% (i.e., noninferiority margin).|||0.00007515|<0.001
73930049|NCT06561217|147390077|SUPERIORITY|The primary study was powered on a retrospective, paired, superiority design to evaluate abstraction accuracy of elements commonly used to help screen patients for clinical trials.|Mean Difference (Final Values)|0.02||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A Shapiro-Wilk test was used to assess normality of paired differences in chart-level accuracy (alpha = 0.05). A one-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test the null hypothesis of whether chart-level accuracy of the Human+AI arm for EHR chart abstraction was superior to the chart-level accuracy of a Human-alone arm abstraction.||||0.002
73970782|NCT05448105|147481347|OTHER|||||||0.11|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.11
73970783|NCT05448105|147481347|OTHER|||||||0.63|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.63
73970784|NCT05448105|147481347|OTHER|||||||0.12|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.12
73970785|NCT05448105|147481347|OTHER|||||||0.33|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.33
74088164|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0011|TWO_SIDED|95.0|1.26|2.5|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|1.26|0.0011
73862944|NCT03007745|147271897|SUPERIORITY||Mean Difference (Final Values)|1.96|STANDARD_DEVIATION|3.08|<|0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
73862945|NCT03007745|147271897|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_DEVIATION|3.97|<|0.0001|TWO_SIDED||||||t-test, 2 sided|Unadjusted||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
73930050|NCT06561217|147390078|EQUIVALENCE|Null hypothesis: True difference is equal to 0. Alternate hypothesis: true difference is not equal to 0|Median Difference (Final Values)|0.66||||0.513|TWO_SIDED|95.0|-1.25|2.55|||Wilcoxon (Mann-Whitney)|||A two-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test for difference between chart-level efficiency of the Human+AI arm and chart-level efficiency of the Human-alone arm abstraction.||2.55|-1.25|0.513
73930051|NCT00613509|147390100|SUPERIORITY_OR_OTHER|||||||0.9406|TWO_SIDED|95.0|||||Log Rank|||||||0.9406
73970786|NCT05448105|147481347|OTHER|||||||0.23|||||||McNemar|||Analysis of pre-post change in knowledge of definition of urine microalbumin||||0.23
73970787|NCT05448105|147481347|OTHER|||||||0.58|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for urine microalbumin||||0.58
73970788|NCT05448105|147481347|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of body mass index (BMI)||||1.00
73970789|NCT05448105|147481347|OTHER|||||||0.27|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for body mass index (BMI)||||0.27
73970790|NCT05270408|147481349|SUPERIORITY||Cohen's d|0.93||||0.25|TWO_SIDED||||||ANCOVA|||RAVLT Total Learning||||0.25
73970791|NCT05270408|147481349|SUPERIORITY||Cohen's d|0.69||||0.18|TWO_SIDED||||||ANCOVA|||RAVLT Total Learning||||0.18
73970792|NCT05270408|147481349|SUPERIORITY||Cohen's d|0.74||||0.48|TWO_SIDED||||||ANCOVA|||RAVLT Delayed||||0.48
73970793|NCT05270408|147481349|SUPERIORITY||Cohen's d|0.19||||0.64|TWO_SIDED||||||ANCOVA|||RAVLT Delayed||||0.64
73970794|NCT05270408|147481350|SUPERIORITY||Cohen's d|0.03||||0.98|TWO_SIDED||||||ANCOVA|||BVMT total learning||||0.98
73970795|NCT05270408|147481350|SUPERIORITY||Cohen's d|0.86||||0.22|TWO_SIDED||||||ANCOVA|||BVMT total learning||||0.22
73970796|NCT05270408|147481350|SUPERIORITY||Cohen's d|0.04||||0.97|TWO_SIDED||||||ANCOVA|||BVMT delayed||||0.97
73970797|NCT05270408|147481350|SUPERIORITY||Cohen's d|0.69||||0.23|TWO_SIDED||||||ANCOVA|||BVMT delayed||||0.23
73970798|NCT05270408|147481351|SUPERIORITY||Cohen's d|0.04||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
73970799|NCT05270408|147481351|SUPERIORITY||Cohen's d|0.42||||0.47|TWO_SIDED||||||ANCOVA|||||||0.47
73970800|NCT05270408|147481352|SUPERIORITY||Cohen's d|1.49||||0.06|TWO_SIDED||||||ANCOVA|||||||0.06
73970801|NCT05270408|147481352|SUPERIORITY||Cohen's d|1.08||||0.07|TWO_SIDED||||||ANCOVA|||||||0.07
73970802|NCT05270408|147481353|SUPERIORITY||Cohen's d|0.19||||0.61|TWO_SIDED||||||ANCOVA|||||||0.61
73970803|NCT05270408|147481353|SUPERIORITY||Cohen's d|0.68||||0.38|TWO_SIDED||||||ANCOVA|||||||0.38
73970804|NCT05270408|147481355|SUPERIORITY||Cohen's d|0.96||||0.11|TWO_SIDED||||||ANCOVA|||||||0.11
73970805|NCT05270408|147481355|SUPERIORITY|||||||0.68|||||||ANCOVA||||Eta2 effect sizes produced from the pairwise comparisons were transformed to Cohen's d for examination of effect sizes. A small/weak effect size was demonstrated (Cohen's d = 0.10), when adjusting for baseline performance.|||0.68
73970806|NCT00324805|147481476|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9|TWO_SIDED|95.0|0.82|1.19|||Regression, Cox||Arm II versus Arm I|||1.19|0.82|0.90
73970807|NCT00324805|147481477|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.86|1.15|||Regression, Cox||Arm II vs. Arm I|||1.15|0.86|0.95
73970808|NCT02606422|147481514|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
73970809|NCT04625465|147481535|OTHER||Difference in the log odds ratios|0.042||||0.869|||||||Multilevel logistic regression|||"Multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2) with interaction between alcohol use and CBT Intervention.~Testing the difference in odds ratio between groups 1 (No Intervention and Attention Control ) and 2 (CBT Texts Intervention) H0: OR1 = OR2"||||.869
73862946|NCT03007745|147271897|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.61||0.9171|TWO_SIDED|||||Adjusted mean changes and adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values|ANCOVA|||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. ANCOVA model included main effects for type of study (home versus in-laboratory), site, and the pre-treatment baseline value of the outcome measure.||||0.9171
73862947|NCT03007745|147271897|NON_INFERIORITY|We hypothesized that the lower bound of the non-inferiority analysis of FOSQ-10 would be greater than the a-priori threshold of -1.0.|||||>|0.05||||||"Adjusted group difference in mean change in FOSQ-10 score from baseline to Month 3, controlling for baseline FOSQ and site, was -0.06 ± 061 (SEM) (P = 0.917).~The lower bound of the 95% noninferiority confidence interval was -1.08"|ANCOVA|||||||>0.05
73862948|NCT03007745|147271898|SUPERIORITY||Mean Difference (Net)|-3.31|STANDARD_DEVIATION|4.86|<|0.0001|ONE_SIDED|||||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group|t-test, 2 sided|||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
73862949|NCT03007745|147271898|SUPERIORITY||Mean Difference (Net)|-3.51|STANDARD_DEVIATION|5.52|<|0.0001|TWO_SIDED|||||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group|t-test, 2 sided|||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group||||<0.0001
73862950|NCT03007745|147271898|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.85||0.9251|ONE_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. ANCOVA model included main effects for type of study (home versus in-laboratory), site, and the pre-treatment baseline value of the outcome measure.||||0.9251
73862951|NCT03007745|147271899|SUPERIORITY|Paired t-test comparing change in score (3-month - baseline) within group|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.33||0.4116|ONE_SIDED||||||t-test, 2 sided|Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||Within arm change from baseline to 3 month follow-up||||0.4116
73862952|NCT03007745|147271899|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.39||0.2201|ONE_SIDED||||||t-test, 2 sided|||Paired t-test comparing change in score (3-month - baseline) within group||||0.2201
73862953|NCT03007745|147271899|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.1732|TWO_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes between groups from baseline to month 3 in participants initiated on CPAP (LOCF applied using 1-month data).||||0.1732
73862954|NCT03007745|147271900|SUPERIORITY||Mean Difference (Final Values)|-2.76|STANDARD_DEVIATION|4.73|<|0.0003|ONE_SIDED||||||t-test, 2 sided|Unadjusted||Paired t-test comparing baseline and 3-month measures within group||||<0.0003
74088165|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0035|TWO_SIDED|95.0|1.19|2.38|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.38|1.19|0.0035
73862955|NCT03007745|147271900|SUPERIORITY||Mean Difference (Final Values)|-2.38|STANDARD_DEVIATION|5.2|<|0.0001|TWO_SIDED||||||t-test, 2 sided|Unadjusted||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group||||<0.0001
73862956|NCT03007745|147271900|SUPERIORITY||Median Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.9||0.673|TWO_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||||0.6730
74088166|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0022
73862957|NCT03007745|147271901|SUPERIORITY||Mean Difference (Net)|-5.94|STANDARD_DEVIATION|6.17|<|0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)||Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)||||<0.0001
73862958|NCT03007745|147271901|SUPERIORITY|Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)|Mean Difference (Final Values)|-5.6|STANDARD_DEVIATION|6.96||0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||||0.0001
73862959|NCT03007745|147271901|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|1.11||0.9903|TWO_SIDED|||||ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure|ANCOVA|Adjusted differences in mean changes estimated as site-total-sample-size weighted values controlling for group differences in mean baseline values||Between group comparison of change in Insomnia Severity Index (ISI) at 3 months (LOCF applied using 1-month data)||||0.9903
73862960|NCT03007745|147271905|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||Between group comparison of Client Satisfaction Questionnaire (CSQ-8) at 3 months (LOCF applied using 1-month data)||||>0.05
73862961|NCT03007745|147271906|NON_INFERIORITY|The a-priori lower bound selected for the non-inferiority analysis of average daily CPAP use over 3 months was -0.75 hours.|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.37||0.308|TWO_SIDED|||||Group difference (REVAMP - In-person) in mean CPAP daily use over all days adjusted for investigative site.|ANCOVA|The lower bound of the 95% noninferiority confidence interval was -0.22.||||||0.308
73970810|NCT04625465|147481536|OTHER||Difference in the log odds ratios|-0.32||||0.21|||||||Multilevel logistic regression|||"Multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2) with interaction between alcohol use and CBT Intervention.~Testing the difference in odds ratio between groups 1 (No Intervention and Attention Control ) and 2 (CBT Texts Intervention) H0: OR1 = OR2"||||.210
73970811|NCT02618577|147481552|SUPERIORITY||adjusted cause-specific hazard ratio|0.81||||0.15|TWO_SIDED|95.0|0.6|1.08|||Cause-spec. Cox Proport. Hazard model|||||1.08|0.6|0.15
73970812|NCT02618577|147481553|SUPERIORITY||adjusted cause-specific hazard ratio|0.79|||||TWO_SIDED|95.0|0.45|1.39||||||||1.39|0.45|
73930052|NCT00613509|147390100|SUPERIORITY_OR_OTHER|||||||0.9179|TWO_SIDED|95.0|||||Likelihood ratio test|||||||0.9179
73970813|NCT02618577|147481554|SUPERIORITY||adjusted cause-specific hazard ratio|0.89|||||TWO_SIDED|95.0|0.67|1.18||||||||1.18|0.67|
73970814|NCT02618577|147481555|SUPERIORITY||adjusted cause-specific hazard ratio|1.16||||0.28|TWO_SIDED|95.0|0.88|1.53|||Cause-spec. Cox Proport. Hazard model|||||1.53|0.88|0.28
73970815|NCT02618577|147481556|SUPERIORITY||adjusted cause-specific hazard ratio|2.1||||0.002|TWO_SIDED|95.0|1.3|3.38|||Cause-spec. Cox Proport. Hazard model|||||3.38|1.3|0.002
73970816|NCT02618577|147481557|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.02|0.01|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|EQ-5D-5L UK Index||0.01|-0.02|
73970817|NCT02618577|147481557|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-1.46|1.38|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|EQ-5D-5L VAS, FU 24months||1.38|-1.46|
73970818|NCT02618577|147481557|SUPERIORITY||Mean Difference (Final Values)|0.27|||||TWO_SIDED|95.0|-0.56|1.09|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|Karnofsky score||1.09|-0.56|
73970819|NCT02618577|147481558|SUPERIORITY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-1.12|0.87|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|PACT-Q convenience||0.87|-1.12|
73970820|NCT02618577|147481558|SUPERIORITY||Mean Difference (Final Values)|-1.04|||||TWO_SIDED|95.0|-2.6|0.52|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|PACT-Q satisfaction||0.52|-2.60|
74029674|NCT01899144|147613868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.1||0.0062|TWO_SIDED|95.0|0.08|0.45|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.45|0.08|0.0062
74029675|NCT01899144|147613868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6342|TWO_SIDED|95.0|-0.23|0.14||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||0.14|-0.23|0.6342
74088167|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0155|TWO_SIDED|95.0|1.11|2.72|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|1.11|0.0155
73970821|NCT02618577|147481561|SUPERIORITY||adjusted cause-specific hazard ratio|0.51|||||TWO_SIDED|95.0|0.27|0.96||||||||0.96|0.27|
73970822|NCT02618577|147481562|SUPERIORITY||adjusted cause-specific hazard ratio|0.9|||||TWO_SIDED|95.0|0.62|1.31||||||||1.31|0.62|
73970823|NCT02151981|147481563|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.001|TWO_SIDED|95.0|0.23|0.41|||Log Rank||A hazard ratio \<1 favours Osimertinib 80mg|||0.41|0.23|<0.001
73970824|NCT02151981|147481564|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.39|||<|0.001|TWO_SIDED|95.0|3.47|8.48|||Regression, Logistic|adjusted for ethnicity (Asian/non-Asian)|odds ratio \>1.0 favours Osimertinib 80 mg|||8.48|3.47|<0.001
73970825|NCT02151981|147481565|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Expected (DoR)|6.22|||<|0.001|TWO_SIDED|95.0|4.04|9.57|||formulae provided in Ellis S et al 2008|Treatments compared by calculating the ratio of the Expected (DoR) using the Log Normal probability distribution for DOR in responding patients||||9.57|4.04|<0.001
73930053|NCT03037528|147390103|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||||||.214
73930054|NCT03037528|147390103|SUPERIORITY|||||||0.017|||||||t-test, 2 sided|||||||.017
73930055|NCT03037528|147390103|SUPERIORITY|||||||0.457|||||||t-test, 2 sided|||||||.457
73930056|NCT03037528|147390103|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||.580
73930057|NCT03037528|147390103|SUPERIORITY|||||||0.275|||||||t-test, 2 sided|||||||.275
73930058|NCT03037528|147390103|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
73970826|NCT02151981|147481566|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.76|||<|0.001|TWO_SIDED|95.0|2.64|8.84|||Regression, Logistic||odds ratio \>1.0 favours Osimertinib 80 mg|||8.84|2.64|<0.001
73970827|NCT02151981|147481567|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-21.62|||<|0.001|TWO_SIDED|95.0|-27.71|-15.52|||ANCOVA|Covariates for ethnicity (Asian, non-Asian) and the baseline sum of diameters of target lesions|LS Mean: Osimertinib -46.93, Chemo -25.3 A difference in LS means \<0 favours Osimertinib 80mg|||-15.52|-27.71|<0.001
73970828|NCT02151981|147481568|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.277|TWO_SIDED|95.0|0.67|1.13|||Log Rank||A hazard ratio \<1 favours Osimertinib 80 mg|||1.13|0.67|0.277
73970829|NCT02151981|147481569|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.16|0.28|||Log Rank||A hazard ratio \<1 favors Osimertinib 80mg|||0.28|0.16|<0.001
73970830|NCT02151981|147481570|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||<|0.001|TWO_SIDED|95.0|0.69|1.11|||Log Rank||A hazard ratio \<1 favours Osimertinib 80 mg|||1.11|0.69|<0.001
74029676|NCT01899144|147613868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0488|TWO_SIDED|95.0|-0.38|0.0||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||0.00|-0.38|0.0488
73862962|NCT01300351|147271907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.078|TWO_SIDED|95.0|0.54|1.03||With a sample size of 220 randomised patients and 150 progression events, if treatment effect is consistent between ethnicities/the study populations, there is an 89% chance the HR \<1.|Log Rank|||The results of this study would be considered to be consistent with that of the CONFIRM study if the hazard ratio (HR) point estimate for the treatment comparison was \<1 (ie, it favoured fulvestrant 500 mg), without the requirement for the benefit of fulvestrant 500 mg to be statistically significant.||1.03|0.54|0.078
73862963|NCT01300351|147271908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.107|TWO_SIDED|95.0|0.93|2.24|||Regression, Logistic|||||2.24|0.93|0.107
73970831|NCT05446168|147481571|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Mean Difference (Net)|-0.08|STANDARD_DEVIATION|0.05||0.005|TWO_SIDED|95.0|-0.12|-0.03||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|t = -4.05, df = 7||||-0.03|-0.12|0.005
73862964|NCT01300351|147271909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.023|TWO_SIDED|95.0|1.04|1.8|||Regression, Logistic|||||1.80|1.04|0.023
73970832|NCT05446168|147481572|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis.|Mean Difference (Net)|4.33|STANDARD_DEVIATION|12.81||0.27|TWO_SIDED|95.0|-3.81|12.47||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|t = 1.17, df = 11||||12.47|-3.81|0.27
74088168|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1549|TWO_SIDED|95.0|0.88|2.2|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.20|0.88|0.1549
73862965|NCT00673881|147271932|SUPERIORITY_OR_OTHER|||||||0.0042||95.0|||||t-test, 2 sided|||||||0.0042
73862966|NCT00673881|147271933|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||Comparison baseline to end-of-treatment||||0.0002
73862967|NCT00673881|147271934|SUPERIORITY_OR_OTHER||||||NS|0|||||||t-test, 2 sided|||Comparison from baseline to end-of-treatment||||NS
73862968|NCT00673881|147271942|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73862969|NCT00413010|147271943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.48||||95.0|-2.16|-0.26|||Mixed Models Analysis|Adjusted for treatment, pooled center baseline, HAM-A total score,time,and treatment-by time|Since an interim analysis was conducted and the sample size was larger than the targeted 173 subjects per group, a critical t-value adjustment was 1.977, yielding an adjusted 95% CI shown above.|Null hypothesis: no difference between Pregabalin (150-600 mg/day) BID and Placebo BID treatment groups. An initial sample size of 173 subjects per double-blind treatment group was calculated to provide at least 90% power to detect an effect size (ie, difference in the true means between 2 treatment groups/standard deviation) of 0.36 for the HAM-A total score change from Baseline using a 2-sided nominal significance level of 4.9%.||-0.26|-2.16|
73970833|NCT04164888|147481627|SUPERIORITY||Least Square Mean|-84.56|STANDARD_ERROR_OF_MEAN|7.137|<|0.0001|TWO_SIDED|95.0|-98.95|-70.18|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-70.18|-98.95|<0.0001
73970834|NCT04164888|147481627|SUPERIORITY||Least Square Mean|-80.43|STANDARD_ERROR_OF_MEAN|7.018|<|0.0001|TWO_SIDED|95.0|-94.58|-66.29|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-66.29|-94.58|<0.0001
73862970|NCT00413010|147271944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.49||||95.0|-2.3|-0.4|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 1||-0.4|-2.3|
73862971|NCT00413010|147271944|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.59||||95.0|-2.2|0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 2||0.1|-2.2|
73862972|NCT00413010|147271944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.62||||95.0|-2.7|-0.2|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 3||-0.2|-2.7|
73862973|NCT00413010|147271944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-2.6|-0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 4||-0.1|-2.6|
73862974|NCT00413010|147271944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.68||||95.0|-2.1|0.5|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 5||0.5|-2.1|
73862975|NCT00413010|147271944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.67||||95.0|-2.5|0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 6||0.1|-2.5|
73970835|NCT04164888|147481627|SUPERIORITY||Least Square Mean|-84.87|STANDARD_ERROR_OF_MEAN|7.009|<|0.0001|TWO_SIDED|95.0|-99.0|-70.75|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-70.75|-99.00|<0.0001
73970836|NCT04164888|147481628|SUPERIORITY||Least Square Mean|-48.03|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|-63.06|-32.99|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||-32.99|-63.06|<0.0001
73862976|NCT00413010|147271944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.77||||95.0|-2.9|0.2|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 8||0.2|-2.9|
73862977|NCT00413010|147271945|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.35||||||95.0|1.37|8.24||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at each week with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1||8.24|1.37|
73862978|NCT00413010|147271945|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||||95.0|0.9|2.87||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2||2.87|0.90|
73862979|NCT00413010|147271945|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.15||||||95.0|1.76|5.66||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3||5.66|1.76|
73862980|NCT00413010|147271945|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||||95.0|1.06|3.05||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4||3.05|1.06|
73862981|NCT00413010|147271945|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||||95.0|0.9|2.73||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5||2.73|0.90|
73862982|NCT00413010|147271945|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||||95.0|0.86|2.66||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6||2.66|0.86|
73862983|NCT00413010|147271945|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86||||||95.0|1.08|3.22||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8||3.22|1.08|
73862984|NCT00413010|147271945|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||||95.0|1.12|2.79||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (last observation carried forward, LOCF)||2.79|1.12|
73862985|NCT00413010|147271946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||||95.0|0.94|8.8||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 1||8.80|0.94|
73862986|NCT00413010|147271946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||||95.0|0.72|3.06||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 2||3.06|0.72|
73862987|NCT00413010|147271946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.08||||||95.0|1.09|3.97||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 3||3.97|1.09|
73930059|NCT03037528|147390103|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||.007
73930060|NCT03037528|147390103|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||||||.142
73930061|NCT03037528|147390104|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||.027
73930062|NCT03037528|147390104|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
73930063|NCT03037528|147390104|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||.054
73930064|NCT03037528|147390104|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||.014
73930065|NCT03037528|147390104|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||.019
73862988|NCT00413010|147271946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||||95.0|0.99|3.28||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 4||3.28|0.99|
73862989|NCT00413010|147271946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||||95.0|0.82|2.85||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 5||2.85|0.82|
73862990|NCT00413010|147271946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||||95.0|0.71|2.48||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 6||2.48|0.71|
73862991|NCT00413010|147271946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||||95.0|0.85|2.83||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8||2.83|0.85|
73862992|NCT00413010|147271946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||||95.0|0.92|2.53|||Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8 Last Observation Carried Foward (LOCF)||2.53|0.92|
73862993|NCT00413010|147271947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0137||||||P-value corresponds to the 2-sided log-rank test.|Log Rank|2-sided log-rank test||Kaplan Meier product limit estimate for calculating median time in days to onset sustained HAM-A Improvement.||||0.0137
73862994|NCT00413010|147271948|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||||95.0|0.96|2.47||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the CGI-I responders at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1||2.47|0.96|
73862995|NCT00413010|147271948|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.58||||||95.0|1.01|2.47||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2||2.47|1.01|
73862996|NCT00413010|147271948|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75||||||95.0|1.09|2.82||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3||2.82|1.09|
73930066|NCT03037528|147390104|SUPERIORITY|||||||0.026|||||||t-test, 2 sided|||||||.026
73862997|NCT00413010|147271948|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||||95.0|0.77|2.05||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4||2.05|0.77|
73862998|NCT00413010|147271948|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||||95.0|0.72|2.11||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5||2.11|0.72|
73930067|NCT03037528|147390104|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||.013
73930068|NCT03037528|147390104|SUPERIORITY|||||||0.163|||||||t-test, 2 sided|||||||.163
73930069|NCT03037528|147390105|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||.018
73930070|NCT03037528|147390105|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
73930071|NCT03037528|147390105|SUPERIORITY|||||||0.134|||||||t-test, 2 sided|||||||.134
73930072|NCT03037528|147390105|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
73930073|NCT03037528|147390105|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||||||.048
73930074|NCT03037528|147390105|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||.066
73930075|NCT03037528|147390105|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||||||.045
73930076|NCT03037528|147390105|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||.053
73930077|NCT01686646|147390116|SUPERIORITY_OR_OTHER||LS Mean DIfference|3.5||||0.0248|TWO_SIDED|95.0|0.4|6.5||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||6.5|0.4|0.0248
73970837|NCT04164888|147481628|SUPERIORITY||Least Square Mean|-49.59|STANDARD_ERROR_OF_MEAN|7.396|<|0.0001|TWO_SIDED|95.0|-64.5|34.69|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||34.69|-64.50|<0.0001
74088169|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0212|TWO_SIDED|95.0|1.18|7.37|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.37|1.18|0.0212
73862999|NCT00413010|147271948|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||||95.0|0.84|2.5|||Regression, Logistic|P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6||2.50|0.84|
73863000|NCT00413010|147271948|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||||95.0|0.61|1.84||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8||1.84|0.61|
73863001|NCT00413010|147271948|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||||95.0|0.71|1.76||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (LOCF) Last Observation Carried Forward||1.76|0.71|
73863002|NCT00413010|147271949|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||||95.0|1.07|2.3||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Cumulative Logit Model|Based on fitting a logistic regression model for ordinal response of CGI-S scores at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. The odds of having an increasingly better response for pregabalin relative to the odds of having an increasingly better response for placebo.|Week 8 Last Observation Carried Forward (LOCF)||2.30|1.07|
73863003|NCT00413010|147271950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||||95.0|-1.5|0.0|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 1||0.0|-1.5|
73863004|NCT00413010|147271950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||||95.0|-1.5|0.2|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 2||0.2|-1.5|
73863005|NCT00413010|147271950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||||95.0|-1.6|0.1|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 3||0.1|-1.6|
73863006|NCT00413010|147271950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||||95.0|-2.1|-0.6|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 4||-0.6|-2.1|
73863007|NCT00413010|147271950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||||95.0|-1.3|0.5|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 5||0.5|-1.3|
73863008|NCT00413010|147271950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||||95.0|-1.8|0.0|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 6||0.0|-1.8|
73863009|NCT00413010|147271950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||||95.0|-2.1|0.1|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 8||0.1|-2.1|
73863010|NCT01533922|147271951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.191|0.298|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 once daily (QD) minus Placebo|||0.298|0.191|<0.0001
73863011|NCT01533922|147271951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.065|0.172|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg|||0.172|0.065|<0.0001
73863012|NCT01533922|147271951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.061|0.167|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.167|0.061|<0.0001
73863013|NCT01533922|147271951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.164|0.271|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.271|0.164|<0.0001
73863014|NCT01533922|147271951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.027||0.0008|TWO_SIDED|95.0|0.038|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.145|0.038|0.0008
73863015|NCT01533922|147271951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.027||0.0015|TWO_SIDED|95.0|0.034|0.141|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.141|0.034|0.0015
73863016|NCT01533922|147271952|SUPERIORITY_OR_OTHER||Ratio|1.209|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|1.132|1.292|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD|||1.292|1.132|<0.0001
73863017|NCT01533922|147271952|SUPERIORITY_OR_OTHER||Ratio|1.002|STANDARD_ERROR_OF_MEAN|0.034||0.9633|TWO_SIDED|95.0|0.937|1.07|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Olodaterol 5 mcg QD|||1.070|0.937|0.9633
74088170|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0373|TWO_SIDED|95.0|1.06|6.57|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.57|1.06|0.0373
74088171|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.29|2.57|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|1.29|0.0006
73930078|NCT01686646|147390116|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.1513|TWO_SIDED|95.0|-0.6|4.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||4.1|-0.6|0.1513
73930079|NCT01686646|147390116|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9|||||TWO_SIDED|95.0|1.1|6.6||Not significant based on hierarchical testing.|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in change from baseline in number of valid responses from RVIP task.||6.6|1.1|
73930080|NCT01686646|147390117|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0696|TWO_SIDED|95.0|-0.2|6.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of accurate responses from the RVIP.||6.1|-0.2|0.0696
73930081|NCT01686646|147390117|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|||||TWO_SIDED|95.0|0.3|5.2||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||5.2|0.3|
73930082|NCT01686646|147390117|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||||TWO_SIDED|95.0|-1.7|3.9||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||3.9|-1.7|
74088172|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.51|3.02|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|1.51|<.0001
74088173|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0152|TWO_SIDED|95.0|1.09|2.18|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|1.09|0.0152
73863018|NCT01533922|147271952|SUPERIORITY_OR_OTHER||Ratio|0.993|STANDARD_ERROR_OF_MEAN|0.033||0.8415|TWO_SIDED|95.0|0.93|1.061|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD|||1.061|0.930|0.8415
73930083|NCT00556842|147390130|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-6.37|||||TWO_SIDED|99.0|-9.18|-3.56||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC total at 24 months.||-3.56|-9.18|
73930084|NCT00556842|147390130|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-0.93|||||TWO_SIDED|99.0|-1.42|-0.44||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC pain at 24 months.||-0.44|-1.42|
73930085|NCT00556842|147390130|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-0.44|||||TWO_SIDED|99.0|-0.65|-0.23||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC stiffness at 24 months.||-0.23|-0.65|
73930086|NCT00556842|147390130|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-4.97|||||TWO_SIDED|99.0|-7.11|-2.83||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC function at 24 months.||-2.83|-7.11|
73930087|NCT00556842|147390131|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Odds Ratio (OR)|0.72|||||TWO_SIDED|99.0|0.38|1.36||||||Using a multi-level model, the effect of THA versus HA on mobility (TUG) was estimated. We analyzed the TUG as a dichotomous outcome with the following categories: a) patients who complete the test in ≤12 seconds, and b) those who require \>12 seconds to complete the test or were unable to complete the test. We selected 12 seconds as the cut-off because this was the threshold used by the Centers for Disease Control and Prevention. The TUG was summarized using odds ratios and 99% CIs.||1.36|0.38|
73930088|NCT00556842|147390132|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|1.41|||||TWO_SIDED|99.0|-0.33|3.14||||||Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 PCS at 24 months.||3.14|-0.33|
73930089|NCT00556842|147390132|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|1.34|||||TWO_SIDED|99.0|-0.38|3.05||||||Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 MCS at 24 months.||3.05|-0.38|
73930090|NCT00556842|147390133|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|0.04|||||TWO_SIDED|99.0|-0.03|0.11||||||Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D utility index at 24 months.||0.11|-0.03|
73930091|NCT00556842|147390133|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|0.72|||||TWO_SIDED|99.0|-2.02|3.46||||||Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D VAS at 24 months.||3.46|-2.02|
73930092|NCT00308711|147390135|SUPERIORITY_OR_OTHER||Kaplan-Meier|1595.5||||0.974||||||The a priori threshold for statistical significance was 0.05.|Log Rank||This was a Kaplan-Meier analysis of median time to vaginal delivery. Cervidil was compared separately to MVI 100 and MVI 50.|Null hypothesis was that there would be no difference in time to vaginal delivery for MVI 100 compared to time to vaginal delivery for Cervidil.||||0.974
73930093|NCT00308711|147390135|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1977.0||||0.011||95.0|1977.0|2253.0|||Log Rank|||||2253|1977|0.011
73930094|NCT00308711|147390136|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority (NI) margin was within 15% relative to the rate of cesarean section for the comparator (Cervidil 10 mg dinoprostone vaginal insert).|Cox Proportional Hazard|27.8||||0.64||95.0|23.61|32.31|||Fisher Exact|||||32.31|23.61|0.64
73970838|NCT04164888|147481628|SUPERIORITY||Least Square Mean|-51.99|STANDARD_ERROR_OF_MEAN|7.616|<|0.0001|TWO_SIDED|95.0|-67.34|-36.64|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||-36.64|-67.34|<0.0001
73970839|NCT04409353|147481630|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 30, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.47||||0.4884|TWO_SIDED|95.0|-0.87|1.81||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.81|-0.87|0.4884
73970840|NCT04409353|147481630|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 30, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.16||||0.8095|TWO_SIDED|95.0|-1.12|1.43||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.43|-1.12|0.8095
74088174|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0018|TWO_SIDED|95.0|1.23|2.45|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.23|0.0018
73930095|NCT00308711|147390136|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was rate of cearean section within 15% of Cervidil rate.|Cox Proportional Hazard|28.0||||0.59||95.0|23.86|32.42|||Fisher Exact|||||32.42|23.86|0.59
73930096|NCT01723228|147390176|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.8||||0.2204|TWO_SIDED|95.0|-0.48|2.05|||repeated measures model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||2.05|-0.48|0.2204
73930097|NCT01723228|147390177|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1||||0.8428|TWO_SIDED|95.0|-0.99|0.81|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||0.81|-0.99|0.8428
73930098|NCT01723228|147390178|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7||||0.4796|TWO_SIDED|95.0|-2.74|1.3|||ANCOVA|The statistical model is an analysis of covariance (ANCOVA) with treatment, center, baseline score, and age as fixed effects.||||1.30|-2.74|0.4796
73930099|NCT01723228|147390179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.1148|TWO_SIDED|95.0|0.89|2.93|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC||2.93|0.89|0.1148
73930100|NCT01723228|147390179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1052|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the Cochran-Mantel-Haenszel (CMH) p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC||||0.1052
73930101|NCT01723228|147390179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.8857|TWO_SIDED|95.0|0.52|1.75|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Cognition||1.75|0.52|0.8857
73930102|NCT01723228|147390179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9945|TWO_SIDED|||||For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.|Cochran-Mantel-Haenszel|||CGIC Cognition||||0.9945
73930103|NCT01723228|147390179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.6909|TWO_SIDED|95.0|0.56|2.43|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Behavior||2.43|0.56|0.6909
73930104|NCT01723228|147390179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6639|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Behavior||||0.6639
73930105|NCT01723228|147390179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.3204|TWO_SIDED|95.0|0.72|2.68|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Functional Abilities||2.68|0.72|0.3204
73863019|NCT01533922|147271952|SUPERIORITY_OR_OTHER||Ratio|1.265|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|1.184|1.351|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD|||1.351|1.184|<0.0001
73863020|NCT01533922|147271952|SUPERIORITY_OR_OTHER||Ratio|1.047|STANDARD_ERROR_OF_MEAN|0.035||0.1717|TWO_SIDED|95.0|0.98|1.119|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD|||1.119|0.980|0.1717
73863021|NCT01533922|147271952|SUPERIORITY_OR_OTHER||Ratio|1.039|STANDARD_ERROR_OF_MEAN|0.035||0.261|TWO_SIDED|95.0|0.972|1.11|||Mixed Models Analysis||Ratio calculated asTiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD|||1.110|0.972|0.2610
73863022|NCT01533922|147271953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0004|TWO_SIDED|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||-0.001|-0.004|0.0004
73930106|NCT01723228|147390179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3331|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Functional Abilities||||0.3331
73930107|NCT01723228|147390180|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.5||||0.0151|TWO_SIDED|95.0|-4.47|-0.49|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||-0.49|-4.47|0.0151
73930108|NCT01723228|147390181|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.3||||0.0003|TWO_SIDED|95.0|-3.53|-1.08|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||-1.08|-3.53|0.0003
73930109|NCT04084769|147390254|OTHER|95% Confidence Interval (CI) of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Difference in percentage|1.65|||||TWO_SIDED|95.0|-3.58|6.95||||||Serogroup A||6.95|-3.58|
73970841|NCT04409353|147481631|OTHER|The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.79||||0.3101|TWO_SIDED|95.0|-0.74|2.32||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||2.32|-0.74|0.3101
73970842|NCT04409353|147481631|OTHER|The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.42||||0.6328|TWO_SIDED|95.0|-2.13|1.3||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.30|-2.13|0.6328
73863023|NCT01533922|147271953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.8291|TWO_SIDED|95.0|-0.001|0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.002|-0.001|0.8291
73863024|NCT01533922|147271953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.857|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.8570
73863025|NCT01533922|147271953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||-0.002|-0.005|<0.0001
73863026|NCT01533922|147271953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.7294|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.001|-0.002|0.7294
73863027|NCT01533922|147271953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.4567|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.4567
73930110|NCT04084769|147390254|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.74|||||TWO_SIDED|95.0|-5.5|1.6||||||Serogroup C||1.60|-5.50|
73930111|NCT04084769|147390254|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.15|||||TWO_SIDED|95.0|-4.09|1.14||||||Serogroup Y||1.14|-4.09|
73930112|NCT04084769|147390254|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.16|||||TWO_SIDED|95.0|-4.72|2.07||||||Serogroup W||2.07|-4.72|
73930113|NCT03390504|147390264|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.0031|TWO_SIDED|95.0|0.48|0.86|||Log Rank|||||0.86|0.48|=0.0031
73930114|NCT03390504|147390264|SUPERIORITY||Hazard Ratio (HR)|1.16|||=|0.2121|TWO_SIDED|95.0|0.92|1.48|||Stratified log-rank test|||||1.48|0.92|=0.2121
73930115|NCT03091192|147390328|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.313|TWO_SIDED|95.0|0.37|1.36|||Log Rank|||||1.36|0.37|0.313
73930116|NCT03091192|147390329|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.11|TWO_SIDED|95.0|0.21|1.17|||Log Rank||A hazard ratio \< 1 favours Savolitinib|||1.17|0.21|0.110
73930117|NCT04487080|147390342|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0002|TWO_SIDED|95.0|0.58|0.85|||Log Rank||HR and its 95% CI was estimated based on a stratified Cox's regression model with treatment as the sole explanatory variable.|||0.85|0.58|0.0002
73863028|NCT01533922|147271954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.293|0.352|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.352|0.293|<0.0001
73930118|NCT03890367|147390392|NON_INFERIORITY|The two-sided 97.5 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was greater than (\>) -10%.|Difference in Percentage|10.43|||||TWO_SIDED|97.5|5.68|16.2||||||||16.2|5.68|
73930119|NCT03890367|147390393|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|16.3|||||TWO_SIDED|97.5|12.7|21.0||||||||21.0|12.7|
73930120|NCT03890367|147390394|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|16.3|||||TWO_SIDED|97.5|12.7|21.0||||||||21.0|12.7|
73970843|NCT04409353|147481631|OTHER|The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.16||||0.126|TWO_SIDED|95.0|-0.33|2.64||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||2.64|-0.33|0.1260
73970844|NCT04409353|147481631|OTHER|The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.51||||0.515|TWO_SIDED|95.0|-2.05|1.03||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.03|-2.05|0.5150
73970845|NCT04409353|147481632|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.43||||0.018|TWO_SIDED|95.0|0.25|2.61||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.||2.61|0.25|.0180
74088175|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.47||||0.097|TWO_SIDED|95.0|0.93|2.31|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|0.93|0.0970
73930121|NCT03890367|147390395|SUPERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The superiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>0%.|Difference in Percentage|10.43|||||TWO_SIDED|97.5|5.68|16.2||||||||16.20|5.68|
73930122|NCT03890367|147390396|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|0.0|||||TWO_SIDED|97.5|-2.3|2.28||||||||2.28|-2.30|
73863029|NCT01533922|147271954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.101|0.16|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.160|0.101|<0.0001
73930123|NCT03890367|147390397|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|1.32|||||TWO_SIDED|97.5|1.06|1.64||||||||1.64|1.06|
73930124|NCT03890367|147390398|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|1.32|||||TWO_SIDED|97.5|1.06|1.64||||||||1.64|1.06|
73930125|NCT03890367|147390399|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|5.24|||||TWO_SIDED|97.5|1.83|9.85||||||||9.85|1.83|
73930126|NCT03890367|147390400|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|6.8|||||TWO_SIDED|97.5|5.04|9.18||||||||9.18|5.04|
73930127|NCT03890367|147390401|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|6.8|||||TWO_SIDED|97.5|5.04|9.18||||||||9.18|5.04|
73930128|NCT03890367|147390402|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|0.0|||||TWO_SIDED|97.5|-2.71|2.67||||||||2.67|-2.71|
73930129|NCT03890367|147390403|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|2.27|||||TWO_SIDED|97.5|1.82|2.84||||||||2.84|1.82|
73930130|NCT03890367|147390404|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|2.27|||||TWO_SIDED|97.5|1.82|2.84||||||||2.84|1.82|
73930131|NCT02533921|147390405|SUPERIORITY||Mean Difference (Final Values)|1.5022|STANDARD_ERROR_OF_MEAN|0.6749||0.0272|TWO_SIDED|95.0|0.1706|2.8338|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||2.8338|0.1706|0.0272
73930132|NCT02533921|147390406|SUPERIORITY||Mean Difference (Final Values)|-1.1236|STANDARD_ERROR_OF_MEAN|0.8267||0.1761|TWO_SIDED|95.0|-2.7569|0.5097|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.5097|-2.7569|0.1761
74088176|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3435|TWO_SIDED|95.0|0.79|1.98|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.98|0.79|0.3435
73930133|NCT02533921|147390407|SUPERIORITY||Mean Difference (Final Values)|-0.4616|STANDARD_ERROR_OF_MEAN|0.3889||0.2369|TWO_SIDED|95.0|-1.2291|0.3059|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.3059|-1.2291|0.2369
73930134|NCT02533921|147390408|SUPERIORITY||Mean Difference (Final Values)|-0.1309||||0.7484|TWO_SIDED|95.0|-0.9349|0.673|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|||0.6730|-0.9349|0.7484
73930135|NCT02533921|147390409|SUPERIORITY||Mean Difference (Final Values)|-0.6878|STANDARD_ERROR_OF_MEAN|0.4789||0.1529|TWO_SIDED|95.0|-1.6338|0.2581|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.2581|-1.6338|0.1529
73930136|NCT02533921|147390410|SUPERIORITY||Mean Difference (Final Values)|-0.1608|STANDARD_ERROR_OF_MEAN|0.3934||0.6834|TWO_SIDED|95.0|-0.9382|0.6167|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.6167|-0.9382|0.6834
73930137|NCT03370341|147390420|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).||||.56
73930138|NCT03370341|147390421|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).||||.38
73930139|NCT02449356|147390422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
73930140|NCT02449356|147390423|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73930141|NCT00533949|147390436|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.38||||0.0042|TWO_SIDED|95.0|1.09|1.76|||Log Rank||Reference group = 60 gy|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 \& 3 vs arms 2 \& 4; for cetuximab, arms 1 \& 2 vs arms 3 \& 4.||1.76|1.09|0.0042
73930142|NCT00533949|147390436|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.07||||0.29|TWO_SIDED|95.0|0.84|1.35|||Log Rank||Reference level = cetuximab|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 \& 3 vs arms 2 \& 4; for cetuximab, arms 1 \& 2 vs arms 3 \& 4.||1.35|0.84|0.29
73970846|NCT04409353|147481632|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.33||||0.5742|TWO_SIDED|95.0|-1.48|0.82||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.||0.82|-1.48|0.5742
74029677|NCT00751881|147613870|SUPERIORITY_OR_OTHER||Relative risk reduction (%)|36.3||||0.0001|TWO_SIDED|95.0||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 14 mg compared to placebo|"Null hypothesis:~* H1: No difference between teriflunomide 14 mg and placebo~* H2: No difference between teriflunomide 7 mg and placebo~The study was sized to have 94% power to detect a 25% relative risk reduction in ARR with teriflunomide compared to placebo at a 2-sided 0.05 significance level."||||0.0001
74029678|NCT00751881|147613870|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|22.3||||0.0183|TWO_SIDED|95.0||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 7 mg compared to placebo|||||0.0183
74029679|NCT00751881|147613871|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|31.5||||0.0442|TWO_SIDED|95.0||||"Step down approach:~* S1 tested only if both comparisons on the primary outcome measure were statistically significant~* S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~* S1: No difference between teriflunomide 14 mg and placebo~* S2: No difference between teriflunomide 7 mg and placebo~The study was also sized to have 75% power to detect a 37% hazard ratio reduction in time to disability progression with teriflunomide compared to placebo."||||0.0442
73930143|NCT00533949|147390437|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.19||||0.12|TWO_SIDED|95.0|0.95|1.47|||Log Rank||Reference level = 60 Gy|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.47|0.95|0.12
73930144|NCT00533949|147390437|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.89|TWO_SIDED|95.0|0.8|1.22|||Log Rank||Reference level = cetuximab|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05.||1.22|0.80|0.89
73930145|NCT00533949|147390438|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.24|TWO_SIDED|95.0|0.89|1.53|||Gray's test||Reference level = 60 Gy|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.53|0.89|0.24
74029680|NCT00751881|147613871|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|4.5||||0.762|TWO_SIDED|95.0||||"Step down approach:~* S1 tested only if both comparisons on the primary outcome measure were statistically significant~* S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|||||0.7620
74029681|NCT02273323|147613894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.43|TWO_SIDED|0.23|-0.37|0.83|||Mixed Models Analysis|||Estimated effect of tea vs placebo||0.83|-0.37|0.43
74088177|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0236|TWO_SIDED|95.0|1.17|9.27|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.27|1.17|0.0236
73930146|NCT00533949|147390438|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.22|TWO_SIDED|95.0|0.64|1.1|||Gray's test||Reference level = cetuximab|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.10|0.64|0.22
73863030|NCT01533922|147271954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.084|0.143|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.143|0.084|<0.0001
73863031|NCT01533922|147271954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.256|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.315|0.256|<0.0001
73930147|NCT00533949|147390439|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Esophagitis: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.||||<0.0001
73930148|NCT00533949|147390439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2533|||||||Chi-squared|||PNEUMONITIS: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.||||0.2533
73930149|NCT00533949|147390440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|||||||Chi-squared|||Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of of toxicity at any time was classified by a binary grouping of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test.||||0.52
73930150|NCT00533949|147390442|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0233|||||||Cochran-Mantel-Haenszel|||FACT-TOI-LCS was assessed and changes from baseline to 3 months calculated and grouped using a 2 point decline as the threshold. Comparisons of decline vs no decline by RT level were from a Cochran-Mantel-Haenszel test and controlling for cetuximab assignment using a two-side significance level of 0.05.||||0.0233
73930151|NCT00533949|147390443|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.92
73970847|NCT04409353|147481633|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.39||||0.7338|TWO_SIDED|95.0|-1.85|2.62||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- Anxiety score obtained at Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.||2.62|-1.85|0.7338
73970848|NCT04409353|147481633|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.63||||0.5279|TWO_SIDED|95.0|-1.34|2.6||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Anxiety score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.||2.60|-1.34|0.5279
73970849|NCT04409353|147481634|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.19||||0.1833|TWO_SIDED|95.0|-0.56|2.94||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.||2.94|-0.56|0.1833
73970850|NCT04409353|147481634|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.33||||0.7006|TWO_SIDED|95.0|-2.04|1.37||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.||1.37|-2.04|0.7006
73970851|NCT04409353|147481635|OTHER||Common Odds Ratio|0.76||||0.1913|TWO_SIDED|95.0|0.5|1.15||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||1.15|0.50|0.1913
73970852|NCT04409353|147481635|OTHER||Common Odds Ratio|0.83||||0.367|TWO_SIDED|95.0|0.55|1.24||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||1.24|0.55|0.3670
73970853|NCT04409353|147481636|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.83||||0.1619|TWO_SIDED|95.0|-1.98|0.33||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.||0.33|-1.98|0.1619
74088178|NCT02709486|147729979|SUPERIORITY||Odds Ratio (OR)|3.14||||0.0296|TWO_SIDED|95.0|1.12|8.81|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||8.81|1.12|0.0296
73863032|NCT01533922|147271954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.063|0.123|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.123|0.063|<0.0001
73863033|NCT01533922|147271954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.047|0.106|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.106|0.047|<0.0001
73930152|NCT00533949|147390444|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.19
73930153|NCT00533949|147390445|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.78|TWO_SIDED|95.0|0.68|1.33|||Regression, Cox||Reference level = EGFR H-Score \< 200|Univariate model of overall survival by EGFR group||1.33|0.68|0.78
73930154|NCT00533949|147390445|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.61|TWO_SIDED|95.0|0.74|1.65|||Regression, Cox||Reference level = EGFR H-Score \< 200|Univariate model of time to local-regional failure by EGFR group||1.65|0.74|0.61
73930155|NCT00533949|147390446|SUPERIORITY|||||||0.02||||||Two-sided significance level = 0.05|Chi-squared|||||||0.02
73930156|NCT00533949|147390447|OTHER||Cox Proportional Hazard|1.001||||0.06|TWO_SIDED|95.0|1.0|1.002||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Univariate model with GTV as a continuous variable||1.002|1.000|0.06
73930157|NCT00533949|147390447|SUPERIORITY||Hazard Ratio (HR)|1.001||||0.78|TWO_SIDED|95.0|0.997|1.004||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Multivariate model with GTV as a continuous variable, adjusting for planned radiation therapy dose group (60 Gy or 74 Gy) and the interaction of GTV and planned dose.|P-Value for the interaction of GTV and planned dose = 0.77|1.004|0.997|0.78
74029682|NCT02273323|147613895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.2|TWO_SIDED|95.0|-0.4|1.82|||Mixed Models Analysis|Subject=random factor; treatment, on/off medication, period = fixed effects||Estimated effect of tea vs. placebo||1.82|-0.40|0.20
73863034|NCT00140842|147271960|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.0|STANDARD_DEVIATION|16.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis was that there is no difference between the groups for peak growth hormone on the growth hormone stimulation test.||||<0.05
73930158|NCT00533949|147390448|SUPERIORITY||Cox Proportional Hazard|1.0||||0.94|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of overall survival time by PET SUV as a continuous variable||1.02|0.98|0.94
73930159|NCT00533949|147390448|SUPERIORITY||Cox Proportional Hazard|1.0||||0.72|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to local-regional failure by PET SUV as a continuous variable||1.02|0.98|0.72
73930160|NCT00533949|147390448|SUPERIORITY||Cox Proportional Hazard|1.0||||0.79|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to distant metastasis by PET SUV as a continuous variable||1.02|0.98|0.79
74029683|NCT02273323|147613896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||||TWO_SIDED|95.0|-5.26|2.55|||Mixed Models Analysis|||||2.55|-5.26|
74029684|NCT02273323|147613897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.16|1.37|||Mixed Models Analysis|||||1.37|-2.16|
74029685|NCT02273323|147613898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|||||TWO_SIDED|95.0|-4.65|0.87|||Mixed Models Analysis|||||0.87|-4.65|
73930161|NCT00727194|147390450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.25||||0.0144|TWO_SIDED|95.0|-7.45|-1.05||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||||-1.05|-7.45|0.0144
73930162|NCT00727194|147390450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.71||||0.117|TWO_SIDED|95.0|-10.8|1.37||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||||1.37|-10.80|0.1170
73930163|NCT00727194|147390451|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared|||||||1.0000
73930164|NCT00727194|147390451|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606|TWO_SIDED|||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared|||||||0.0606
73930165|NCT00727194|147390452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.58||||0.1873|TWO_SIDED|95.0|-4.08|0.91||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||||0.91|-4.08|0.1873
73930166|NCT00727194|147390452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.57||||0.041|TWO_SIDED|95.0|-6.97|-0.17||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||||-0.17|-6.97|0.0410
73930167|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83||||0.919|TWO_SIDED|95.0|-16.94|18.6||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Physical Functioning||18.60|-16.94|0.9190
73930168|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.86||||0.5931|TWO_SIDED|95.0|-39.05|23.33||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Functioning||23.33|-39.05|0.5931
73930169|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|3.13||||0.7319|TWO_SIDED|95.0|-16.64|22.89||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Role Physical||22.89|-16.64|0.7319
73930170|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-7.14||||0.691|TWO_SIDED|95.0|-45.36|31.08||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Physical||31.08|-45.36|0.6910
73930171|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.42||||0.1311|TWO_SIDED|95.0|-22.18|3.34||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Bodily Pain||3.34|-22.18|0.1311
73930172|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.86||||0.2406|TWO_SIDED|95.0|-41.08|11.36||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Bodily Pain||11.36|-41.08|0.2406
73930173|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.17||||0.0578|TWO_SIDED|95.0|-0.29|14.62||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||General Health||14.62|-0.29|0.0578
73930174|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.43||||0.5073|TWO_SIDED|95.0|-16.26|31.11||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||General Health||31.11|-16.26|0.5073
73930175|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.17||||0.2474|TWO_SIDED|95.0|-3.39|11.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Vitality||11.72|-3.39|0.2474
73930176|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.68||||0.8085|TWO_SIDED|95.0|-26.24|20.88||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Vitality||20.88|-26.24|0.8085
73930177|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.46||||0.0716|TWO_SIDED|95.0|-24.13|1.21||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Social Functioning||1.21|-24.13|0.0716
73930178|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.07||||0.1966|TWO_SIDED|95.0|-41.68|9.54||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Social Functioning||9.54|-41.68|0.1966
73863035|NCT00140842|147271961|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|23.7|STANDARD_DEVIATION|12.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis is that there is no difference between the groups for visceral adipose tissue||||<0.05
73863036|NCT02553538|147271965|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73930179|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.81||||0.1701|TWO_SIDED|95.0|-29.6|5.99||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Role Emotional||5.99|-29.60|0.1701
73930180|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.95||||0.7422|TWO_SIDED|95.0|-32.58|44.48||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Emotional||44.48|-32.58|0.7422
73930181|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.42||||0.9007|TWO_SIDED|95.0|-6.83|7.67||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Health||7.67|-6.83|0.9007
73930182|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.86||||0.1519|TWO_SIDED|95.0|-7.57|43.29||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Health||43.29|-7.57|0.1519
74029686|NCT02273323|147613899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||||TWO_SIDED|95.0|-0.73|4.09|||Mixed Models Analysis|||||4.09|-0.73|
73863037|NCT02553538|147271966|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Logistic|||||||<0.001
73863038|NCT02553538|147271967|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Logistic|||||||<0.001
73930183|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.07||||0.6807|TWO_SIDED|95.0|-4.57|6.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Physical Component Score||6.72|-4.57|0.6807
73930184|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.23||||0.2226|TWO_SIDED|95.0|-16.79|4.32||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Component Score||4.32|-16.79|0.2226
73930185|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.92||||0.1505|TWO_SIDED|95.0|-7.1|1.26||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Component Score||1.26|-7.10|0.1505
73930186|NCT00727194|147390453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.55||||0.4151|TWO_SIDED|95.0|-8.77|19.87||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Component Score||19.87|-8.77|0.4151
74029687|NCT03117049|147613900|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|96.37|0.43|0.71|||Stratified log-rank test|||||0.71|0.43|<0.0001
73863039|NCT02553538|147271968|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73863040|NCT02690649|147271969|SUPERIORITY||estimated adherence rate for the interve|94.0||||0.28|TWO_SIDED|95.0|92.0|95.0|||Regression, Linear|||estimated adherence rate for the intervention group Generalized linear models were used to test the effect of the intervention on medication adherence. These generalized linear models used a Poisson distribution to estimate the rate of adherence with the log of total prescribed doses as an offset term in the linear predictor.||95|92|0.28
73863041|NCT02690649|147271970|SUPERIORITY||||||<|0.001||||||A negative binomial distribution because the outcome was a count variable and it was over-dispersed.|Regression, Linear|Age, previous patient portal logins, and gender were used as co-variates in the model.||||||<0.001
73930187|NCT00727194|147390454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.25||||0.3377|TWO_SIDED|95.0|-3.94|10.44||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Forced Vital Capacity||10.44|-3.94|0.3377
73930188|NCT00727194|147390454|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-10.57||||0.3391|TWO_SIDED|95.0|-33.71|12.56||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Forced Vital Capacity||12.56|-33.71|0.3391
73930189|NCT00727194|147390454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-4.35|4.35||No multiple comparisons or multiplicity adjustments were conducted.|paired t test|||Negative Inspiratory Force||4.35|-4.35|1.0000
73930190|NCT00727194|147390454|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.57||||0.2292|TWO_SIDED|95.0|-17.87|4.73||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Negative Inspiratory Force||4.73|-17.87|0.2292
73930191|NCT04269161|147390467|NON_INFERIORITY|The margin of non-inferiority is 10 seconds such that the device is no worse than 10 seconds on average than manual mode. Our study is a 2-treatment, 24-period crossover design that accounts for first-order carryover effects, indicating a slightly higher power than a 2x2. Each subject acted as their own control. The study was defined as intention to treat, such that manual adjustments during the automated arm would be included in that arm.|Mean Difference (Net)|-9.885||||0.003|TWO_SIDED|95.0|-16.51|-3.27||The p-value is significant at 0.01.|t-test, 2 sided||The difference is time to re-establish in automatic mode minus time to re-establish in manual mode. (a negative number favors automatic mode)|A sample requirement of 48 patients was determined based on a pilot study to provide 88% power, and 0.05 significance (two sided) to show the mean difference is less than 10 seconds based on a 2x2 crossover design. Considering patient drop-out, a sample size of n=40 drops power to 82%.||-3.27|-16.51|0.003
74029688|NCT03117049|147613901|SUPERIORITY||Stratified hazard ratio|0.85|||||TWO_SIDED|95.0|0.63|1.14||||||||1.14|0.63|
74029689|NCT03117049|147613902|SUPERIORITY||Odds Ratio (OR)|1.55|||||TWO_SIDED|95.0|1.11|2.17||||||||2.17|1.11|
74029690|NCT03117049|147613903|SUPERIORITY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.46|1.31||||||||1.31|0.46|
74029691|NCT00839098|147613909|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
74029692|NCT00839098|147613910|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
74029693|NCT00839098|147613911|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
74029694|NCT00839098|147613912|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
74029695|NCT00839098|147613913|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
74029696|NCT00839098|147613914|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||P values below 0.05 were considered statistically significant in this study.|Wilcoxon (Mann-Whitney)|||||||>0.05
74029697|NCT00839098|147613915|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73863042|NCT02690649|147271971|SUPERIORITY||Slope|-0.61||||0.03|TWO_SIDED|95.0|-1.14|-0.07||baseline AF knowledge, gender, age, and educational level were all used as co-variates.|Regression, Linear|generalized linear model tested whether AF knowledge at study completion was related to baseline AF knowledge, gender, age, and educational level||||-0.07|-1.14|0.03
73863043|NCT00907296|147271988|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3598|TWO_SIDED|95.0|0.53|1.26|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.26|0.53|0.3598
73863044|NCT00907296|147271988|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.6544|TWO_SIDED|95.0|0.59|1.39|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.39|0.59|0.6544
73863045|NCT00907296|147271988|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9958|TWO_SIDED|95.0|0.64|1.58|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.58|0.64|0.9958
73863046|NCT00907296|147271988|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6276|TWO_SIDED|95.0|0.59|1.37|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.37|0.59|0.6276
73863047|NCT00907296|147271988|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8819|TWO_SIDED|95.0|0.63|1.49|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.49|0.63|0.8819
73863048|NCT00907296|147271988|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7197|TWO_SIDED|95.0|0.6|1.42|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.42|0.60|0.7197
73863049|NCT00907296|147271988|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.6204|TWO_SIDED|95.0|0.73|1.7|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.70|0.73|0.6204
73863050|NCT00907296|147271988|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4779|TWO_SIDED|95.0|0.75|1.84|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.84|0.75|0.4779
73863051|NCT00907296|147271988|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9952|TWO_SIDED|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.53|0.65|0.9952
73970854|NCT04409353|147481636|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.04||||0.9569|TWO_SIDED|95.0|-1.31|1.24||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.||1.24|-1.31|0.9569
74029698|NCT00121810|147613916|SUPERIORITY_OR_OTHER||Median Difference (Net)|18.7||||0.012||95.0|4.2|33.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||The primary analysis tested the null hypothesis that mean percent change from baseline to 12 months for Group 1 (mycophenolate mofetil + sirolimus) was equal to that for Group 2 (mycophenolate mofetil + cyclosporine or tacrolimus) based on the intent-to-treat population.||33.2|4.2|0.012
74029699|NCT00121810|147613917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.543||95.0|-9.6|18.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) type as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||||18.2|-9.6|0.543
74088179|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|2.14||||0.0132|TWO_SIDED|95.0|1.17|3.9|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.90|1.17|0.0132
74088180|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1274|TWO_SIDED|95.0|0.87|3.02|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|0.87|0.1274
73930192|NCT04269161|147390468|OTHER|The difference is defined as the difference of proportion of time in the target range of SpO2 in modes, automatic minus manual. Our study is a 2-treatment, 24-period crossover design that accounts for first-order carryover effects, indicating a slightly higher power than a 2x2. Each subject acted as their own control. The study was defined as intention to treat, such that manual adjustments during the automated arm would be included in that arm.|Mean Difference (Net)|0.018||||0.02|TWO_SIDED|95.0|0.003|0.034||The threshold for statistical significance is p=.05|t-test, 2 sided|Two-sample t test with equal variances. Linear mixed model patient random effects, adjusted for site, sex, race, weight, gestational age, bed type.|Treatment difference = automatic - manual. A positive number favors automatic.|The difference in the proportion of time in the target saturation is calculated between the automatic and manual models. For each 6-hour time block, we calculate the proportion of time the patient stays within the prescribed SpO2 range.||.034|0.003|.02
73930193|NCT04368429|147390470|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in percentage was greater than (\>) -10% for the serogroup A.|Difference in percentage|20.27|||||TWO_SIDED|95.0|11.38|28.75|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup A||28.75|11.38|
73930194|NCT04368429|147390470|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup C.|Difference in percentage|33.98|||||TWO_SIDED|95.0|26.2|41.5|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup C||41.50|26.20|
73930195|NCT04368429|147390470|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup Y.|Difference in percentage|34.22|||||TWO_SIDED|95.0|26.66|41.64|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup Y||41.64|26.66|
73930196|NCT04368429|147390470|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup W.|Difference in percentage|38.19|||||TWO_SIDED|95.0|28.93|46.53|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup W||46.53|28.93|
73930197|NCT01706952|147390480|SUPERIORITY_OR_OTHER|For surgical field grade, we calculated the mean within sides and assessed its difference, reporting a 95% confidence interval as calculated by a Student t test. We used the average per patient over time.||||||0.05|||||||t-test, 2 sided|||Data analysis was performed using SPSS version 13 for Windows (SPSS Inc, Chicago, IL). A power study was per formed with a power of 80% and a clinically significant difference in bleeding between the sides of 20% with a significance level of 5% (p \< 0.05).|"For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference, reporting a 95% con- fidence interval as calculated by a Student t test. As all of these values were measured over time, we used the average per patient over time. The total blood loss per side within subjects was also calculated, with 95% confidence interval again calculated by a Student t test. Once again, we took the average per patient over time as the main outcome.~Finally, we used a linear regression with surgical field improvement as the outcome and HR, MAP, or etCO2 as covariates, to investigate which variables may be related to the outcome. As these measures were taken over time, we used repeated measures analysis to investigate how these items correlate over time.~In addition to the operating surgeon, the statistician was blinded to the vasoconstrictor allocation."|||0.05
73970855|NCT04409353|147481637|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.03||||0.9727|TWO_SIDED|95.0|-1.8|1.86||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.||1.86|-1.80|0.9727
73971408|NCT04508309|147483472|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.71|||||TWO_SIDED|98.3|1.389|2.102|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.102|1.389|
74088181|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0016|TWO_SIDED|95.0|1.44|4.76|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.76|1.44|0.0016
73930198|NCT02453113|147390496|SUPERIORITY||||||||||||||||||The statistical end point of the study will be the changes in density of CD11c+ dermal dendritic cells between two biopsies from a study subject where one sample is subjected to laser irradiation and the other is the control. For assessment of statistical significance, we will apply a paired sample t-test.|||
73930199|NCT02896400|147390509|SUPERIORITY||Odds Ratio (OR)|1.8||||0.01|TWO_SIDED|95.0|1.1|2.8|||Regression, Logistic|Adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including BNI (BNI only, BNI+NRT, BNI+QL, BNI+Text, BNI+NRT+QL, BNI+NRT+Text, BNI+QL+Text, BNI+NRT+QL+Text) compared to the 8 arms that do not include BNI (Control, NRT only, QL only, Text only, NRT+QL, NRT+Text, QL+Text, NRT+QL+Text)||2.8|1.1|.01
73970856|NCT04409353|147481637|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.43||||0.6427|TWO_SIDED|95.0|-1.4|2.26||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.||2.26|-1.40|0.6427
73971409|NCT04508309|147483477|NON_INFERIORITY|Non-inferiority of the Cecolin containing arm (Group 5) compared to Gardasil at months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.75|||||TWO_SIDED|95.0|1.476|2.071|||||GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||2.071|1.476|
74029700|NCT00121810|147613918|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.8||||0.003||95.0|-17.9|-3.7||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||-3.7|-17.9|0.003
73930200|NCT02896400|147390509|SUPERIORITY||Odds Ratio (OR)|2.1||||0.001|TWO_SIDED|95.0|1.3|3.2|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms that include NRT (NRT only, BNI+NRT, NRT+QL, NRT+Text, BNI+NRT+QL, BNI+NRT+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include NRT (Control, BNI only, QL only, Text only, BNI+QL, BNI+Text, QL+Text, BNI+QL+Text)||3.2|1.3|.001
73930201|NCT02896400|147390509|SUPERIORITY||Odds Ratio (OR)|1.4||||0.14|TWO_SIDED|95.0|0.9|2.2|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including QL intervention (QL only, BNI+QL, NRT+QL, QL+Text, BNI+NRT+QL, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to all 8 arms that did not include QL (Control, BNI only, NRT only, Text only, BNI+NRT, BNI+Text, NRT+Text, BNI+NRT+Text)||2.2|0.9|0.14
74029701|NCT00121810|147613918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.0||||0.108||95.0|-35.4|3.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||3.5|-35.4|0.108
74029702|NCT00121810|147613918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.4||||0.039||95.0|-47.7|-1.2||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||-1.2|-47.7|0.039
74029703|NCT00121810|147613919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7|||<|0.001||95.0|4.1|13.3||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||13.3|4.1|<0.001
74029704|NCT00121810|147613919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9||||0.029||95.0|0.7|13.1||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||13.1|0.7|0.029
74088182|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.0001|TWO_SIDED|95.0|1.84|6.03|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.03|1.84|<.0001
73930202|NCT02896400|147390509|SUPERIORITY||Odds Ratio (OR)|1.1||||0.64|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including Text (Text only, BNI+Text, NRT+Text, QL+Text, BNI+NRT+Text, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include Text (Control, BNI only, NRT only, QL only, BNI+NRT, BNI+QL, NRT+QL, BNI+NRT+QL)||1.7|0.7|0.64
74029705|NCT00121810|147613919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.8||||0.015||95.0|1.7|15.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||15.9|1.7|0.015
74088183|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0089|TWO_SIDED|95.0|1.2|3.49|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.49|1.20|0.0089
73930203|NCT02984020|147390520|OTHER||Odds Ratio (OR)|0.77|||<|0.0001||95.0|0.69|0.86|||Regression, Logistic|Multiple logistic regression including total treatment duration of Xeljanz as factor||||0.86|0.69|<0.0001
73930204|NCT02984020|147390520|OTHER||Odds Ratio (OR)|2.43|||<|0.0001||95.0|1.64|3.59|||Regression, Logistic|Multiple logistic regression including other past/present disease as factor||||3.59|1.64|<0.0001
73930205|NCT02984020|147390531|OTHER||Odds Ratio (OR)|1.42||||0.0053|TWO_SIDED|95.0|1.11|1.82|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Xeljanz as factor||||1.82|1.11|0.0053
73930206|NCT00326612|147390584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0||||||||||||
73930207|NCT00326612|147390585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.2|3.9||||||||3.9|0.2|
73930208|NCT00326612|147390586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.4|2.7||||||||2.7|0.4|
73930209|NCT00326612|147390587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.2|8.2||||||||8.2|0.2|
73930210|NCT00326612|147390588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.0|67.3||||||||67.3|0.0|
73930211|NCT00326612|147390589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|0.2|140.7||||||||140.7|0.2|
73930212|NCT00548808|147390592|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 0.4% for HbA1c was used.|Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.716|TWO_SIDED|95.0|-0.25|0.17|||ANCOVA|ANCOVA Model: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.17|-0.25|0.716
73970857|NCT04409353|147481638|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|691.58||||0.291|TWO_SIDED|95.0|-602.98|1986.14||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.||1986.14|-602.98|0.2910
73930213|NCT00548808|147390593|SUPERIORITY_OR_OTHER|||||||0.279||95.0||||P-value for 16 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.279
73930214|NCT00548808|147390593|SUPERIORITY_OR_OTHER|||||||0.846||95.0||||P-value for 32 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.846
73930215|NCT00548808|147390593|SUPERIORITY_OR_OTHER|||||||0.741||95.0||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.741
73971410|NCT04508309|147483478|NON_INFERIORITY|Non-inferiority of the Cecolin containing arm (Group 5) compared to Gardasil at months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.21|||||TWO_SIDED|95.0|1.004|1.451|||||GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.451|1.004|
74029706|NCT00121810|147613920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5|||<|0.001||95.0|4.2|12.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||12.9|4.2|<0.001
73863052|NCT00907296|147271991|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.1713|TWO_SIDED|95.0|0.47|1.14|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.14|0.47|0.1713
73930216|NCT00548808|147390594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.465|TWO_SIDED|95.0|0.41|1.5||P-value for patients achieving HbA1c \<6.5% at 16 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.50|0.41|0.465
73930217|NCT00548808|147390594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.365|TWO_SIDED|95.0|0.51|1.28||P-value for Patients Achieving HbA1c \<7% at 16 Weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.28|0.51|0.365
73930218|NCT00548808|147390594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.683|TWO_SIDED|95.0|0.65|1.95||P-value for patients achieving HbA1c \<6.5% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.95|0.65|0.683
73930219|NCT00548808|147390594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.81|TWO_SIDED|95.0|0.68|1.64||P-value for patients achieving HbA1c \<7% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.64|0.68|0.810
73930220|NCT00548808|147390594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.555|TWO_SIDED|95.0|0.69|2.01||P-value for patients achieving HbA1c \<6.5% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||2.01|0.69|0.555
73930221|NCT00548808|147390594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.829|TWO_SIDED|95.0|0.67|1.64||P-value for patients achieving HbA1c \<7% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.64|0.67|0.829
73930222|NCT00548808|147390596|SUPERIORITY_OR_OTHER|||||||0.604||95.0||||P-value for Week 16 Change from Baseline|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.604
73930223|NCT00548808|147390596|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-value for Week 32 Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.814
73930224|NCT00548808|147390596|SUPERIORITY_OR_OTHER|||||||0.582||95.0||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.582
73930225|NCT00548808|147390599|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.162|TWO_SIDED|95.0|-0.26|0.04||P-value for Cholesterol.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.04|-0.26|0.162
73930226|NCT00548808|147390599|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.165|TWO_SIDED|95.0|-0.3|0.05||P-value for Triglycerides.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.05|-0.30|0.165
74029707|NCT00121810|147613920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.8||||0.059||95.0|-0.2|11.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||11.9|-0.2|0.059
74029708|NCT00121810|147613920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5||||0.036||95.0|0.5|14.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||14.5|0.5|0.036
74029709|NCT01354691|147613933|SUPERIORITY||||||<|0.67|||||||ANCOVA|||||||<0.67
74029710|NCT01354691|147613934|SUPERIORITY||||||<|0.21|||||||ANCOVA|||||||<0.21
73930227|NCT00548808|147390599|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.51|TWO_SIDED|95.0|-0.18|0.09||P-value for Low Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.09|-0.18|0.510
73930228|NCT00548808|147390599|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.382|TWO_SIDED|95.0|-0.02|0.06||P-value for High Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.06|-0.02|0.382
73930229|NCT02099721|147390638|EQUIVALENCE|The equivalence margin is a hazard ratio significantly above 0.70.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.38|0.57|||||The hazard ratio, estimated by a Cox proportional hazard model, has time to first treated VT/VF for 1.5 Prevention in the numerator, with Secondary Prevention in the denominator.|"H0: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) ≤ 0.70~HA: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) \> 0.70"||0.57|0.38|
73930230|NCT02099721|147390639|SUPERIORITY|A hazard ratio significantly below 1 indicates reduced mortality in the 1.5 implanted group.|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.4|0.66||The p-value is for the effect of treatment group on time to death, adjusting for the baseline covariates of age, gender, QRS duration, ischemic cardiomyopathy, LBBB, NYHA classification, diabetes, LVEF, syncope, NSVT and PVCs.|Wald chi-square||Multiple imputations were employed to account for missing baseline covariates.|The null hypothesis is that the hazard ratio of implanted to non-implanted 1.5 patients = 1. The alternative is that the ratio is not equal to 1.||0.66|0.40|< 0.0001
73930231|NCT03670810|147390644|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.001|TWO_SIDED|95.0|2.56|5.73|||Regression, Logistic|||||5.73|2.56|<0.001
73930232|NCT03670810|147390644|SUPERIORITY||Odds Ratio (OR)|4.56|||<|0.001|TWO_SIDED|95.0|3.07|6.77|||Regression, Logistic|||||6.77|3.07|<0.001
73930233|NCT03670810|147390645|SUPERIORITY||Odds Ratio (OR)|3.77|||<|0.001|TWO_SIDED|95.0|2.1|6.76|||Regression, Logistic|||||6.76|2.10|<.001
73930234|NCT03670810|147390645|SUPERIORITY||Odds Ratio (OR)|7.24|||<|0.001|TWO_SIDED|95.0|4.13|12.67|||Regression, Logistic|||||12.67|4.13|<.001
73930235|NCT03670810|147390646|SUPERIORITY||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|2.05|3.57|||Regression, Logistic|||||3.57|2.05|<0.001
73930236|NCT03670810|147390646|SUPERIORITY||Odds Ratio (OR)|2.68|||<|0.001|TWO_SIDED|95.0|2.04|3.53|||Regression, Logistic|||||3.53|2.04|<0.001
73930237|NCT03670810|147390647|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|2.11|4.01|||Regression, Logistic|||||4.01|2.11|<0.001
73930238|NCT03670810|147390647|SUPERIORITY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.53|4.85|||Regression, Logistic|||||4.85|2.53|<0.001
73930239|NCT03670810|147390648|SUPERIORITY||Odds Ratio (OR)|3.52|||<|0.001|TWO_SIDED|95.0|2.05|6.02|||Regression, Logistic|||||6.02|2.05|<0.001
73930240|NCT03670810|147390648|SUPERIORITY||Odds Ratio (OR)|4.67|||<|0.001|TWO_SIDED|95.0|2.77|7.88|||Regression, Logistic|||||7.88|2.77|<0.001
73930241|NCT03670810|147390649|SUPERIORITY||Odds Ratio (OR)|2.3||||0.004|TWO_SIDED|95.0|1.3|4.04|||Regression, Logistic|||||4.04|1.30|0.004
73930242|NCT03670810|147390649|SUPERIORITY||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.41|6.94|||Regression, Logistic|||||6.94|2.41|<0.001
73930243|NCT03670810|147390650|SUPERIORITY||Odds Ratio (OR)|3.29|||<|0.001|TWO_SIDED|95.0|1.8|6.02|||Regression, Logistic|||||6.02|1.80|<0.001
73930244|NCT03670810|147390650|SUPERIORITY||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|1.97|6.42|||Regression, Logistic|||||6.42|1.97|<0.001
73930245|NCT03670810|147390651|SUPERIORITY||Odds Ratio (OR)|2.22|||<|0.001|TWO_SIDED|95.0|1.48|3.33|||Regression, Logistic|||||3.33|1.48|<0.001
73930246|NCT03670810|147390651|SUPERIORITY||Odds Ratio (OR)|2.46|||<|0.001|TWO_SIDED|95.0|1.65|3.67|||Regression, Logistic|||||3.67|1.65|<0.001
74029711|NCT01354691|147613935|SUPERIORITY||||||<|0.78|||||||ANCOVA|||||||<0.78
74029712|NCT01354691|147613936|SUPERIORITY||||||=|0.83|||||||ANCOVA|||||||=0.83
74029713|NCT01354691|147613937|SUPERIORITY||||||=|0.77|||||||ANCOVA|||||||=.77
73930247|NCT03670810|147390652|SUPERIORITY||Odds Ratio (OR)|2.73||||0.031|TWO_SIDED|95.0|1.1|6.78|||Regression, Logistic|||||6.78|1.10|0.031
73930248|NCT03670810|147390652|SUPERIORITY||Odds Ratio (OR)|5.64|||<|0.001|TWO_SIDED|95.0|2.4|13.25|||Regression, Logistic|||||13.25|2.40|<0.001
73930249|NCT03670810|147390653|SUPERIORITY||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.29|2.35|||Regression, Logistic|||||2.35|1.29|<0.001
73930250|NCT03670810|147390653|SUPERIORITY||Odds Ratio (OR)|1.63||||0.001|TWO_SIDED|95.0|1.21|2.2|||Regression, Logistic|||||2.20|1.21|0.001
73930251|NCT03670810|147390654|SUPERIORITY||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.65|||Regression, Logistic|||||0.65|0.33|<0.001
73930252|NCT03670810|147390654|SUPERIORITY||Odds Ratio (OR)|0.43|||<|0.001|TWO_SIDED|95.0|0.3|0.6|||Regression, Logistic|||||0.60|0.30|<0.001
73930253|NCT03670810|147390655|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.79|4.28|||Regression, Logistic|||||4.28|1.79|<0.001
73930254|NCT03670810|147390655|SUPERIORITY||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.2|5.15|||Regression, Logistic|||||5.15|2.20|<0.001
73930255|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|6.4||||0.086|TWO_SIDED|95.0|0.77|53.37|||Regression, Logistic|||Pain Freedom 30 Min. Postdose||53.37|0.77|0.086
73930256|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|7.24||||0.065|TWO_SIDED|95.0|0.89|59.08|||Regression, Logistic|||Pain Freedom 30 Min. Postdose||59.08|0.89|0.065
73930257|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|3.08||||0.004|TWO_SIDED|95.0|1.42|6.68|||Regression, Logistic|||Pain Free 1 Hour Postdose||6.68|1.42|0.004
73930258|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|7.04|||<|0.001|TWO_SIDED|95.0|3.43|14.44|||Regression, Logistic|||Pain Free 1 Hour Postdose||14.44|3.43|<0.001
73930259|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|1.41||||0.065|TWO_SIDED|95.0|0.98|2.03|||Regression, Logistic|||Pain Relief 30 Min Postdose 100 mg||2.03|0.98|0.065
74029714|NCT00408421|147613962|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.||Null hypothesis: the difference in 24-hour average pain score between duloxetine and placebo treatment groups at last visit of treatment phase is zero. This study will have at least 80% power to detect a treatment group difference of 1.0 point in the baseline-to-endpoint mean change on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups based on Baseline Observation Carried Forward (BOCF).||||<0.001
74029715|NCT00408421|147613963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.001||95.0|-0.84|-0.21||Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|ANCOVA|||An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), PGI severity at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean outcome measure at endpoint.||-0.21|-0.84|0.001
73930260|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|1.77||||0.001|TWO_SIDED|95.0|1.25|2.52|||Regression, Logistic|||Pain Relief 30 Min. Postdose 200 mg||2.52|1.25|0.001
73930261|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|2.31|||<|0.001|TWO_SIDED|95.0|1.74|3.06|||Regression, Logistic|||Pain Relief 1 Hour Postdose 100 mg||3.06|1.74|<0.001
73930262|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.64|2.88|||Regression, Logistic|||Pain Relief 1 Hour Postdose 200 mg||2.88|1.64|<0.001
73930263|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|1.11||||0.651|TWO_SIDED|95.0|0.71|1.71|||Regression, Logistic|||Freedom from MBS 30 Min 100 mg||1.71|0.71|0.651
73930264|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|1.3||||0.22|TWO_SIDED|95.0|0.85|1.98|||Regression, Logistic|||Freedom from MBS 30 Min. 200 mg||1.98|0.85|0.220
73930265|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|1.1||||0.593|TWO_SIDED|95.0|0.78|1.54|||Regression, Logistic|||Freedom from MBS 1 Hour 100 mg||1.54|0.78|0.593
73930266|NCT03670810|147390657|SUPERIORITY||Odds Ratio (OR)|1.43||||0.03|TWO_SIDED|95.0|1.04|1.98|||Regression, Logistic|||Freedom from MBS 1 Hour 200 mg||1.98|1.04|0.030
73930267|NCT03670810|147390658|SUPERIORITY|||||||0.092|||||||ANCOVA|||||||0.092
73930268|NCT03670810|147390658|SUPERIORITY|||||||0.211|||||||ANCOVA|||||||0.211
73930269|NCT03670810|147390659|SUPERIORITY||Odds Ratio (OR)|2.85|||<|0.001|TWO_SIDED|95.0|2.01|4.05|||Regression, Logistic|||||4.05|2.01|<0.001
73930270|NCT03670810|147390659|SUPERIORITY||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|2.12|4.26|||Regression, Logistic|||||4.26|2.12|<0.001
73930271|NCT03670810|147390660|SUPERIORITY|||||||0.056|||||||ANOVA|||Social Functioning||||0.056
73930272|NCT03670810|147390660|SUPERIORITY|||||||0.267|||||||ANOVA|||Social Functioning||||0.267
73930273|NCT03670810|147390660|SUPERIORITY|||||||0.003|||||||ANOVA|||Migraine Symptoms 100 mg||||0.003
73930274|NCT03670810|147390660|SUPERIORITY|||||||0.002|||||||ANOVA|||Migraine Symptoms 200 mg||||0.002
73930275|NCT03670810|147390660|SUPERIORITY|||||||0.014|||||||ANOVA|||Feeling/Concerns 100 mg||||0.014
73930276|NCT03670810|147390660|SUPERIORITY|||||||0.018|||||||ANOVA|||Feelings/Concerns 200 mg||||0.018
73930277|NCT03670810|147390661|SUPERIORITY||Odds Ratio (OR)|1.25||||0.101|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic|||Recommend Treatment - Agree Strongly Agree||1.62|0.96|0.101
73863053|NCT00907296|147271991|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9958|TWO_SIDED|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.53|0.65|0.9958
73863054|NCT00907296|147271991|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.295|TWO_SIDED|95.0|0.81|1.97|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.97|0.81|0.2950
73863055|NCT00907296|147271991|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0844|TWO_SIDED|95.0|0.44|1.05|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.05|0.44|0.0844
73863056|NCT00907296|147271991|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3225|TWO_SIDED|95.0|0.52|1.24|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.24|0.52|0.3225
73863057|NCT00907296|147271991|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.4754|TWO_SIDED|95.0|0.76|1.81|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.81|0.76|0.4754
73863058|NCT00907296|147271991|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5578|TWO_SIDED|95.0|0.74|1.75|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.75|0.74|0.5578
73863059|NCT00907296|147271991|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.1864|TWO_SIDED|95.0|0.87|2.07|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||2.07|0.87|0.1864
73863060|NCT00907296|147271991|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8488|TWO_SIDED|95.0|0.68|1.59|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.59|0.68|0.8488
73863061|NCT00357656|147272007|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority by the 200% margin of non-inferiority was demonstrated if the upper confidence limit of a 95% 2-sided confidence interval for the ratio of means did not exceed 200%.|Mean ratio CI/BI|0.924||||0.001|TWO_SIDED|95.0|0.816|1.046||one-sided p-value against the null hypothesis of ration \>=200%|Hypothesis test|||The main analysis used a point estimate and a two-sided 95% confidence interval for ratio of the primary outcome measure of CI over BI combined over the three strata: stratum A: unilateral knee replacement, stratum B: hip surgery, stratum C: shoulder/elbow/ankle/knee (except knee replacement) surgery.||1.046|0.816|0.001
73863062|NCT02573246|147272014|SUPERIORITY|Aimed to recruit 20 participants in each condition to align with other neurostimulation studies where 6-20 adults per condition were sufficient to demonstrate proof-of-concept for novel treatments (Bentwich et al., 2011; Cunningham et al., 2015).|Mean Difference (Net)|-0.323|STANDARD_ERROR_OF_MEAN|0.131||0.019|TWO_SIDED|95.0|-0.59|-0.056||A priori threshold for significance was .05.|Mixed Models Analysis||The results presented are between the active right and sham conditions.|A mixed models analysis of variance (MMANOVA) examining regulation duration during each regulation period was conducted using treatment condition (active right, active left, sham), experimental condition (regulation1, regulation2, regulation3), and baseline as predictors.||-.056|-.590|0.019
73863063|NCT02573246|147272014|SUPERIORITY||Mean Difference (Net)|0.237|STANDARD_ERROR_OF_MEAN|0.133||0.08|TWO_SIDED|95.0|-0.034|0.508|||Mixed Models Analysis|||A mixed models analysis of variance (MMANOVA) examining regulation duration during each regulation period was conducted using treatment condition (active right, active left, sham), experimental condition (regulation1, regulation2, regulation3), and baseline as predictors.||.508|-.034|.08
73930278|NCT03670810|147390661|SUPERIORITY||Odds Ratio (OR)|1.28||||0.063|TWO_SIDED|95.0|0.99|1.67|||Regression, Logistic|||Recommend Treatment Agree/Strongly Agree||1.67|0.99|0.063
73930279|NCT03670810|147390661|SUPERIORITY||Odds Ratio (OR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.16|||Regression, Logistic|||Willing to Take This Treatment Again - Agree/Strongly Agree||1.16|0.68|0.376
74088184|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0012|TWO_SIDED|95.0|1.42|4.1|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.10|1.42|0.0012
73930280|NCT03670810|147390661|SUPERIORITY||Odds Ratio (OR)|0.79||||0.082|TWO_SIDED|95.0|0.6|1.03|||Regression, Logistic|||Willing to Take This Treatment Again - Agree/Strongly Agree||1.03|0.60|0.082
73863064|NCT02573246|147272014|SUPERIORITY||Mean Difference (Net)|-0.227|STANDARD_ERROR_OF_MEAN|0.103||0.033|TWO_SIDED|95.0|-0.434|-0.02||A priori threshold for significance was set to .05.|Mixed Models Analysis|we controlled for baseline and for the distance between the brain and the scalp||Regulation duration was transformed using a logarithmic transformation to achieve normality||-.020|-.434|.033
73863065|NCT02573246|147272015|SUPERIORITY||Mean Difference (Net)|-0.124|STANDARD_ERROR_OF_MEAN|0.184||0.51|TWO_SIDED|95.0|-0.504|0.256||A priori set threshold for statistical significance was 0.05|ANOVA|||A univariate general linear model was employed to test of regulation duration, transformed for normality.||.256|-0.504|.51
73863066|NCT02573246|147272015|SUPERIORITY||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.18||0.97|TWO_SIDED|95.0|-0.364|0.378|||ANOVA|||||.378|-.364|.97
73863067|NCT02573246|147272015|SUPERIORITY||Mean Difference (Net)|0.147993|STANDARD_ERROR_OF_MEAN|0.167031||0.39|TWO_SIDED|95.0|-0.215936|0.511921||A priori set significance threshold was 0.05|t-test, 2 sided|||A t test of the variable 'time it took to return to HR baseline', transformed for normality was used to examine between condition differences at the 1 month follow up.||0.511921|-0.215936|0.39
73863068|NCT02573246|147272016|SUPERIORITY|HF-HRV was transformed using the function lg10\*(HF-HRV\*1000000) in order to be normally distributed.|Mean Difference (Net)|0.16|STANDARD_DEVIATION|0.51||0.022|TWO_SIDED|95.0|0.044|0.267||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||In the original study (CR+active left rTMS vs CR+ active right rTMS vs CR+sham rTMS), mixed-effects hierarchical linear models (MMANOVA) with analytically determined covariance structures were used to analyze the repeated measures data. We hypothesized that active neurostimulation would increase HF-HRV during regulation.||.267|.044|.022
73863069|NCT02573246|147272016|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.052||0.0499|TWO_SIDED|95.0|0.000037|0.213074|||Mixed Models Analysis|||MMANOVA||0.213074|0.000037|0.0499
73863070|NCT02573246|147272016|SUPERIORITY|Aimed to recruit 20 participants in each condition to align with other neurostimulation studies where 6-20 adults per condition were sufficient to demonstrate proof-of-concept for novel treatments (Bentwich et al., 2011; Cunningham et al., 2015).|Mean Difference (Net)|0.172|STANDARD_DEVIATION|0.38|<|1e-06|TWO_SIDED|95.0|0.129|0.215||Significance threshold was set at p = 0.05.|Mixed Models Analysis||The MMANOVA analysis used an unstructured covariance structure.|In the supplemental study (CR+active left rTMS with functional targeting vs CR+sham rTMS), mixed-effects hierarchical linear models (MMANOVA) with analytically determined covariance structures were used to analyze the repeated measures data. We hypothesized that active neurostimulation would increase HF-HRV during regulation when compared with sham.||.215|.129|<.000001
73930281|NCT03670810|147390661|SUPERIORITY||Odds Ratio (OR)|1.25||||0.096|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic|||Extremely/Very Satisfied||1.62|0.96|0.096
73930282|NCT03670810|147390661|SUPERIORITY||Odds Ratio (OR)|1.38||||0.016|TWO_SIDED|95.0|1.06|1.8|||Regression, Logistic|||Extremely/Very Satisfied||1.80|1.06|0.016
73930283|NCT03670810|147390661|SUPERIORITY||Odds Ratio (OR)|1.12||||0.445|TWO_SIDED|95.0|0.84|1.49|||Regression, Logistic|||Prefer This Treatment||1.49|0.84|0.445
74029716|NCT00408421|147613964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.41||||0.003||95.0|-2.33|-0.48||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.48|-2.33|0.003
74088185|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0006|TWO_SIDED|95.0|1.45|3.98|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.98|1.45|0.0006
73930284|NCT03670810|147390661|SUPERIORITY||Odds Ratio (OR)|1.19||||0.243|TWO_SIDED|95.0|0.89|1.58|||Regression, Logistic|||||1.58|0.89|0.243
73930285|NCT03670810|147390662|SUPERIORITY|||||||0.142|||||||ANCOVA|||||||0.142
73930286|NCT03670810|147390663|SUPERIORITY||Odds Ratio (OR)|3.01||||0.004|TWO_SIDED|95.0|1.42|6.4|||Regression, Logistic|||||6.40|1.42|0.004
73930287|NCT03670810|147390663|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.22|9.47|||Regression, Logistic|||||9.47|2.22|<0.001
74088186|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|1.92|5.21|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||5.21|1.92|<.0001
73930288|NCT03670810|147390664|SUPERIORITY||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.74|3.62|||Regression, Logistic|||||3.62|1.74|<0.001
73930289|NCT03670810|147390664|SUPERIORITY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|2.5|5.2|||Regression, Logistic|||||5.20|2.50|<0.001
73930290|NCT03670810|147390665|SUPERIORITY||Odds Ratio (OR)|1.01||||0.953|TWO_SIDED|95.0|0.75|1.36|||Regression, Logistic|||Nausea||1.36|0.75|0.953
73930291|NCT03670810|147390665|SUPERIORITY||Odds Ratio (OR)|1.05||||0.768|TWO_SIDED|95.0|0.78|1.41|||Regression, Logistic|||Nausea||1.41|0.78|0.768
73930292|NCT03670810|147390665|SUPERIORITY||Odds Ratio (OR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.71|||Regression, Logistic|||Phonophobia||0.71|0.39|<0.001
73930293|NCT03670810|147390665|SUPERIORITY||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.34|0.62|||Regression, Linear|||Phonophobia||0.62|0.34|<0.001
73930294|NCT03670810|147390665|SUPERIORITY||Odds Ratio (OR)|0.48|||<|0.001|TWO_SIDED|95.0|0.36|0.63|||Regression, Logistic|||Photophobia||0.63|0.36|<0.001
73930295|NCT03670810|147390665|SUPERIORITY||Median Difference (Net)|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.71|||Regression, Logistic|||Photophobia||0.71|0.40|<0.001
74088187|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0203|TWO_SIDED|95.0|1.1|3.06|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.06|1.10|0.0203
73863071|NCT02573246|147272017|SUPERIORITY||Mean Difference (Net)|0.111|STANDARD_ERROR_OF_MEAN|0.091544||0.236|TWO_SIDED|95.0|-0.078086|0.300661||A priori threshold was set to 0.05.|ANCOVA|Brain to skull difference and intake difference in dlPFC activation between regulation and feeling negative were included as confounds.|Parameter estimate is the value of the difference between active stimulation and sham stimulation.|Difference between treatment conditions in dlPFC activation change between feeling negative emotions and downregulation of negative affect a week after intervention, when controlling for baseline activation difference||0.300661|-0.078086|.236
73863072|NCT02573246|147272017|SUPERIORITY||Mean Difference (Net)|0.359024|STANDARD_ERROR_OF_MEAN|0.144067||0.020347|TWO_SIDED|95.0|0.061|0.657049||Threshold was set at 0.05 a priori|ANCOVA|Brain to skull difference and intake difference in vlpfc activation between regulation and feeling negative were included as confounds.||Expected significantly higher activation following active intervention in the vlPFC when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted using FSL featquery. A univariate general linear model excluding one outlier from the active condition was conducted for this outcome measure.||0.657049|0.061000|0.020347
73863073|NCT02573246|147272017|SUPERIORITY||Mean Difference (Net)|0.221683|STANDARD_ERROR_OF_MEAN|0.461481||0.635|TWO_SIDED|95.0|-0.732963|1.17633||A priori threshold was set to .05|ANCOVA|Brain to skull difference and intake difference in vmpfc activation between regulation and feeling negative were included as confounds.||Expected significantly higher activation following active intervention in the vmPFC when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted with FSL featquery.||1.176330|-0.732963|0.635
73863074|NCT02573246|147272017|SUPERIORITY||Mean Difference (Net)|0.179412|STANDARD_ERROR_OF_MEAN|0.178029||0.324|TWO_SIDED|95.0|-0.188868|0.547692||a priori set threshold was 0.05|ANCOVA|Brain to skull difference and intake difference in amygdala activation between regulation and feeling negative were included as confounds.||Expected significantly lower activation following active intervention in the amygdala when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted with featquery (FSL).||0.547692|-0.188868|.324
73863075|NCT02573246|147272017|SUPERIORITY||Mean Difference (Net)|0.021231|STANDARD_ERROR_OF_MEAN|0.071185||0.76819|TWO_SIDED|95.0|-0.126027|0.168489||A priori set threshold was 0.05|ANCOVA|Brain to skull difference and intake difference in insula activation between regulation and feeling negative were included as confounds.||Expected significantly lower activation following active intervention in the insula when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. FSL featquery tool was used to extract ROI (region of interest) data.||0.168489|-0.126027|0.768190
73930296|NCT03670810|147390665|SUPERIORITY||Odds Ratio (OR)|0.46||||0.129|TWO_SIDED|95.0|0.17|1.25|||Regression, Logistic|||Vomiting||1.25|0.17|0.129
74029717|NCT00408421|147613965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.004||95.0|-1.09|-0.22||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.22|-1.09|0.004
74029718|NCT00408421|147613966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.18||||0.001||95.0|-8.33|-2.03||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-2.03|-8.33|0.001
74088188|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.77|4.86|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.86|1.77|<.0001
73863076|NCT02573246|147272018|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.455||0.69|TWO_SIDED|95.0|-0.553|1.293||a priori threshold for significance was 0.05|ANOVA|||Likert-type questions about acceptability were rated on a scale from 0 (not at all) to 9 (extremely) and then averaged to create a mean for acceptability. This average score was normally distributed and therefore was entered into a univariate general linear model where acceptability was entered as a dependent variable and condition as a fixed factor.||1.293|-0.553|0.69
73930297|NCT03670810|147390665|SUPERIORITY||Odds Ratio (OR)|1.12||||0.769|TWO_SIDED|95.0|0.52|2.43|||Regression, Logistic|||Vomiting||2.43|0.52|0.769
74029719|NCT00408421|147613967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.42||||0.004||95.0|-10.72|-2.11||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-2.11|-10.72|0.004
74088189|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0775|TWO_SIDED|95.0|0.95|2.55|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.55|0.95|0.0775
73863077|NCT02573246|147272018|SUPERIORITY||Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.43||0.53|TWO_SIDED|95.0|-0.592|1.139|||ANOVA|||||1.139|-.592|.53
73863078|NCT02573246|147272018|SUPERIORITY||Mean Difference (Net)|-0.66|STANDARD_ERROR_OF_MEAN|0.45||0.15|TWO_SIDED|95.0|-1.59|0.27||a priory threshold for significance was .05|t-test, 2 sided|||we compared differences in acceptability between conditions using an independent samples t-test (acceptability was normally distributed)||0.27|-1.59|0.15
73863079|NCT02573246|147272019|SUPERIORITY||Mean Difference (Net)|0.295|STANDARD_ERROR_OF_MEAN|0.304||0.551|TWO_SIDED|95.0|-0.322|0.912||a priori threshold was set to 0.05|ANOVA|||We compared differences between conditions in the perceived feasibility of the procedures. Feasibility average was normally distributed and therefore a general linear model, univariate was employed to test between condition effects.||0.912|-0.322|0.551
73863080|NCT02573246|147272019|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.281||0.995|TWO_SIDED|95.0|-0.567|0.571|||ANOVA|||||.571|-.567|.995
73863081|NCT02573246|147272019|SUPERIORITY||Mean Difference (Net)|-0.09957|STANDARD_ERROR_OF_MEAN|0.371||0.791|TWO_SIDED|95.0|-0.8672|0.6681||A priori threshold for statistical significance was set to 0.05|t-test, 2 sided|df = 23||We examined differences in feasibility between the active and sham condition in the sub-study where fMRI targeting was utilized. Average feasibility was normally distributed and therefore an independent samples t-test was used to test this outcome.||0.6681|-0.8672|0.791
73930298|NCT02644967|147390667|OTHER|Estimation||||||0.0158||||||P-value of the overall response tested against the null rate of 11% based on 1-sided exact (Clopper-Pearson) test.|One-sided Clopper-Pearson test|||Testing the best overall confirmed response rate against the historical control rate of 0.11 (extracted from the literature review).||||0.0158
73930299|NCT02644967|147390668|OTHER|Estimation|Kaplan-Meier|5.06|||||TWO_SIDED|95.0|3.65|7.0|||||Kaplan-Meier estimate of median PFS in months.|||7.00|3.65|
73930300|NCT02644967|147390669|OTHER|Landmark analysis of overall survival at six (6) months.|Kaplan-Meier|87.5|||||TWO_SIDED|95.0|74.3|94.2|||||Kaplan-Meier estimate of percentage of participants surviving at six (6) months.|||94.2|74.3|
74029720|NCT00408421|147613968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83||||0.005||95.0|-1.4|-0.25||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.25|-1.40|0.005
73863082|NCT02573246|147272020|SUPERIORITY||Mean Difference (Net)|6.04|STANDARD_ERROR_OF_MEAN|8.048||0.61|TWO_SIDED|95.0|-9.522964|21.60462||A priori threshold was set to 0.05|Mixed Models Analysis|||To test the long-term effects of the intervention, a MMANOVA model was conducted examining between-condition differences at the 1-week and 1-month follow-up in the OQ-45. Baseline was co-varied.||21.604620|-9.522964|0.61
73863083|NCT02573246|147272020|SUPERIORITY||Mean Difference (Net)|-0.906|STANDARD_ERROR_OF_MEAN|7.37||0.9|TWO_SIDED|95.0|-15.83|14.02||a priori threshold was set to .05|Mixed Models Analysis|||||14.02|-15.83|.90
73930301|NCT02644967|147390670|OTHER|Landmark analysis of overall survival at twelve (12) months.|Kaplan-Meier|60.0|||||TWO_SIDED|95.0|44.7|72.4|||||Kaplan-Meier estimate of percentage of participants surviving at twelve (12) months.|||72.4|44.7|
73930302|NCT01502644|147390671|OTHER||Mean Difference (Net)|18.0||||0.01|TWO_SIDED|95.0|3.7|32.2|||Linear Mixed Modeling|Group, group×week, average baseline pain, and opioid use at baseline were entered as fixed effects using an autoregressive covariance structure.||||32.2|3.7|0.01
73930303|NCT02388997|147390698|SUPERIORITY|||||||0.59|||||||2-sample t-test with unequal variences|||||||0.59
74029721|NCT00408421|147613969|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.||||||<0.001
73863084|NCT02573246|147272020|SUPERIORITY||Mean Difference (Net)|10.46|STANDARD_ERROR_OF_MEAN|7.93||0.2|TWO_SIDED|95.0|-5.971581|26.892619||threshold was set to 0.05 a priori|Mixed Models Analysis||HLM models used a compound symmetry covariance structure.|||26.892619|-5.971581|.20
73863085|NCT02573246|147272021|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.258||0.034|TWO_SIDED|95.0|-1.062356|-0.043203||A priori threshold was set to .05 for significance.|Mixed Models Analysis|Subjective Units of Distress (SUDS) right before the intervention were co-varied as baseline.|Results reported are for active left vs. sham comparison.|Hypothesized that active neurostimulation would lead to lower daily distress than sham stimulation. We used a hierarchical linear model (HLM) for this analysis with an identity covariance structure (random intercept and random slope).||-0.043203|-1.062356|.034
73930304|NCT02388997|147390699|SUPERIORITY|||||||0.58|||||||2-sample t-test with unequal variances|||||||0.58
73930305|NCT02388997|147390700|SUPERIORITY|||||||0.87|||||||2-sample t-test with unequal variances|||||||0.87
73930306|NCT02388997|147390701|SUPERIORITY|||||||0.55|||||||2-sample t-test with unequal variances|||||||0.55
73930307|NCT02388997|147390702|SUPERIORITY|||||||0.6|||||||2-sample t-test with unequal variances|||||||0.6
73930308|NCT02388997|147390704|SUPERIORITY|||||||0.037||||||The p value is based on the fold change (ratio) of the geometric means of the time (days) to peak symptoms among asthmatics in the omalizumab/placebo treatment groups.|2-sample t-test on the log scale|||||||0.037
73930309|NCT01110915|147390705|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|97.5||2.5||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication rate between the MRI scan and one-month post-MRI \>=10%.||2.5||<0.0001
73930310|NCT01110915|147390706|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.0|||||||||||Farrington-Manning test|A priori threshold for statistical significance was 0.025. Because there were no failures in either group, a p-value could not be calculated.||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||||
73930311|NCT01110915|147390707|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.5|||<|0.0001|TWO_SIDED|95.0|-5.0|5.9||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||5.9|-5.0|<0.0001
74088190|NCT02709486|147729981|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0064|TWO_SIDED|95.0|1.21|3.21|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.21|1.21|0.0064
73970858|NCT04409353|147481638|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|405.68||||0.4842|TWO_SIDED|95.0|-741.79|1553.15||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.||1553.15|-741.79|0.4842
74088191|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.7|-0.27|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.27|-0.70|<.0001
74088192|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.11||0.0009|TWO_SIDED|95.0|-0.58|-0.15|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.15|-0.58|0.0009
73970859|NCT04409353|147481639|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.0||||0.4228|TWO_SIDED|95.0|-1.48|3.49||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.||3.49|-1.48|0.4228
73970860|NCT04409353|147481639|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.28||||0.8363|TWO_SIDED|95.0|-2.92|2.37||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.||2.37|-2.92|0.8363
73970861|NCT04409353|147481640|OTHER||Odds Ratio (OR)|0.83||||0.514|TWO_SIDED|95.0|0.48|1.44||A two-sided test performed at the 0.05 level of significance.|Regression, Logistic||Sham VR as the reference group.|"Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups."||1.44|0.48|0.514
73970862|NCT04409353|147481640|OTHER||Odds Ratio (OR)|1.35||||0.28|TWO_SIDED|95.0|0.78|2.36||A two-sided test performed at the 0.05 level of significance.|Regression, Logistic||Sham VR as the reference group.|"Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups."||2.36|0.78|0.280
73970863|NCT05309291|147481643|NON_INFERIORITY|The null hypothesis to demonstrate non-inferiority using a 10% margin for λ FLC RR can be expressed as: Ho: μT-μR ≤ -3.783. The alternative hypothesis is expressed as: Ha: μT-μR \> -3.783 where μT denotes the Theranova 400 treatment mean and μR denotes the FX 800 treatment mean.|Mean Difference (Final Values)|16.99|STANDARD_DEVIATION|8.86|<|0.0001|TWO_SIDED|95.0|14.84|19.15|||t-test, 2 sided|T-test was utilized to generate a two-sided 95% confidence interval (CI) for the difference in means.||Non-inferiority of the Theranova 400 Dialyzer compared to the FX 800 Dialyzer in regard to the λ FLC RR at the mid-week treatment day dialysis session was assessed.||19.15|14.84|<0.0001
73970864|NCT05309291|147481644|NON_INFERIORITY|The null hypothesis to demonstrate non-inferiority using a 10% margin for ß2-MG RR can be expressed as Ho: μT-μR ≤ -7.848. The alternative hypothesis is expressed as: Ha: μT-μR \> -7.848, where μT denotes the Theranova 400 treatment mean and μR denotes the FX 800 treatment mean.|Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|5.55|<|0.0001|TWO_SIDED|95.0|-2.54|0.16|||t-test, 2 sided|T-test was utilized to generate a two-sided 95% confidence interval (CI) for the difference in means.||Non-inferiority of the Theranova 400 Dialyzer compared to the FX 800 Dialyzer in regard to the β2-MG RR at the mid-week treatment day dialysis session was assessed.||0.16|-2.54|<0.0001
73930312|NCT01110915|147390708|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|1.5||||0.001|ONE_SIDED|95.0|-6.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-6.1|0.0010
73930313|NCT01110915|147390709|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.1||||0.0001|ONE_SIDED|95.0|-4.6|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-4.6|0.0001
73930314|NCT01110915|147390710|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|95.0||1.9||A priori threshold for statistical significance was 0.05.|exact test of binomial proportions|||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans \>= 10%.||1.9||<0.0001
73930315|NCT01110915|147390711|SUPERIORITY_OR_OTHER||Complication rate at 4 months|7.7|||<|0.05|ONE_SIDED|95.0||10.9||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||Null hypothesis: the system-related complication rate between the implant procedure and the 4-months visit \>= 20%.||10.9||<0.05
73930316|NCT00207142|147390712|NON_INFERIORITY_OR_EQUIVALENCE|Efficacy at Week 48 on the Switch Arm was considered to be non-inferior to the Continuation Arm if the lower limit of the 95% Confidence Interval was greater than -15%.|Difference in proportions|2.9||||||95.0|-9.8|15.5|||Normal approximation|||The planned sample size of 178 randomized subjects (89 on each regimen) provides at least 80% power to demonstrate that the response rate on ATV is within a 15% margin of the response rate on ATV/RTV assuming: a 2-sided 95% confidence interval for the difference in response rate between treatment regimens (switch-continuation); a response rate of 85% in both the Continuation and Switch regimens; a margin of -15% for the difference in response rates between treatment regimens.||15.5|-9.8|
73930317|NCT00207142|147390713|SUPERIORITY_OR_OTHER||Difference in Proportions|5.0||||||95.0|-6.0|16.1|||Normal Approximation|||||16.1|-6.0|
73930318|NCT00207142|147390714|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||||95.0|0.5|1.88|||Cox Proportional Hazards Model|||Covariate in the model: treatment regimen.||1.88|0.50|
73930319|NCT00207142|147390715|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||||95.0|0.37|1.9|||Cox Proportional Hazards Model|||Covariate in the model: treatment regimen||1.90|0.37|
73930320|NCT00207142|147390716|SUPERIORITY_OR_OTHER||Difference in means at Week 48|7.0||||||95.0|-38.0|53.0|||Normal approximation|||||53|-38|
73930321|NCT03306264|147390729|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% confidence interval (CI) of the 5-day AUC0-24 ratio of Least Square Mean (LSM) for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.93|||||TWO_SIDED|90.0|92.66|105.6|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||105.6|92.66|
73930322|NCT03306264|147390729|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-24 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|99.64|||||TWO_SIDED|90.0|91.23|108.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||108.8|91.23|
73930323|NCT03306264|147390735|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-inf ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.0|||||TWO_SIDED|90.0|91.8|104.6|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.6|91.80|
73930324|NCT03306264|147390735|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-inf ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|99.61|||||TWO_SIDED|90.0|91.2|108.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||108.8|91.20|
74088193|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.48|-1.00|<.0001
73930325|NCT03306264|147390736|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-last ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.11|||||TWO_SIDED|90.0|91.88|104.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.8|91.88|
73930326|NCT03306264|147390736|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-last ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.11|||||TWO_SIDED|90.0|89.75|107.2|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||107.2|89.75|
73930327|NCT03306264|147390737|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-8 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|97.93|||||TWO_SIDED|90.0|91.74|104.5|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.5|91.74|
73970865|NCT02696707|147481663|NON_INFERIORITY|The non-inferiority margin between groups was set as 4%|Difference|-0.6|||||TWO_SIDED|95.0|-2.5|1.2||||||||1.2|-2.5|
73970866|NCT05292872|147481676|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.143|0.752||1-sided p-values are proportion of bootstrap replicates exceeding null (defined as a HR of 1) in each direction), and the two-tailed p-value is twice the smaller of one-tailed p-values. A two-tailed p-value was calculated for HR using this method.|Nonparametric bootstrap approach|||||0.752|0.143|<.001
73930328|NCT03306264|147390737|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-8 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|97.55|||||TWO_SIDED|90.0|89.32|106.5|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||106.5|89.32|
73930329|NCT04590495|147390784|SUPERIORITY|||||||0.946|||||||Mann Whitney U Test|||||||0.9460
73930330|NCT04590495|147390785|SUPERIORITY|||||||0.5699|||||||Mann Whitney U Test|||||||0.5699
73930331|NCT04590495|147390786|SUPERIORITY|||||||0.6068|||||||t-test, 2 sided|||||||0.6068
73930332|NCT04590495|147390787|SUPERIORITY|||||||0.903|||||||Mann Whitney U Test|||||||0.9030
73930333|NCT04590495|147390788|SUPERIORITY|||||||0.2668|||||||t-test, 2 sided|||||||0.2668
73930334|NCT04590495|147390789|SUPERIORITY|||||||0.8749||||||adjusted for baseline VAMS score|paired t test|||||||0.8749
73930335|NCT04590495|147390790|SUPERIORITY|||||||0.7922||||||adjusted for baseline VAMS score for physical sedation|paired t test|||||||0.7922
73930336|NCT04590495|147390791|SUPERIORITY|||||||0.9925||||||adjusted for baseline SSS score|paired t test|||||||0.9925
73930337|NCT04590495|147390792|SUPERIORITY|||||||0.2628||||||adjusted for baseline score|paired t test|||||||0.2628
73930338|NCT04590495|147390793|SUPERIORITY|||||||0.0347||||||adjusted for baseline scores|paired t test|||||||0.0347
73930339|NCT04590495|147390794|SUPERIORITY|||||||0.6331||||||adjusted for baseline score|paired t test|||||||0.6331
73930340|NCT04590495|147390795|SUPERIORITY|||||||0.472||||||adjusted for baseline score|paired t test|||||||0.4720
73930341|NCT04590495|147390796|SUPERIORITY|||||||0.02||||||adjusted for baseline reaction time|paired t test|||||||0.0200
73930342|NCT04590495|147390797|SUPERIORITY|||||||0.062||||||adjusted for baseline reaction time|paired t test|||||||0.0620
73930343|NCT03591575|147390830|SUPERIORITY|||||||0.0446|||||||Fisher Exact|||Patients who reached the serum ferritin threshold at any time point prior to Month 12 were withdrawn from the study as per protocol, so that they could begin on standard chelation therapy. For these individuals, imputed data were used to estimate the values that would likely have been seen at Month 12 had they remained in the study.||||0.0446
73930344|NCT03591575|147390831|SUPERIORITY|||||||0.0446||||||he p-value shown here is for the difference between the groups at Month 12.|Fisher Exact|||||||0.0446
73930345|NCT01387607|147390837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.1906||0.0001|TWO_SIDED|95.0|-1.1|-0.36||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.36|-1.10|0.0001
73930346|NCT01387607|147390838|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4376||||0.1397|TWO_SIDED|95.0|0.8732|2.3667||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into much/very much improved and other.||2.3667|0.8732|0.1397
73930347|NCT01387607|147390838|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4626||||0.151|TWO_SIDED|95.0|0.8596|2.4886||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into any improvement (participants who were very much improved or much improved or minimally improved) and other.||2.4886|0.8596|0.1510
73930348|NCT01387607|147390839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|1.6804||0.0762|TWO_SIDED|95.0|-6.3|0.32||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.32|-6.30|0.0762
73930349|NCT01387607|147390840|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8924||||0.0044|TWO_SIDED|95.0|1.2007|2.9827||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.|||2.9827|1.2007|0.0044
73930350|NCT01387607|147390841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9683||||0.0189|TWO_SIDED|95.0|1.1151|3.4742||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.|||3.4742|1.1151|0.0189
73930351|NCT01387607|147390842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.427|STANDARD_ERROR_OF_MEAN|2.0152||0.09|TWO_SIDED|95.0|-7.39|0.54||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||||0.54|-7.39|0.0900
73930352|NCT01387607|147390843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.527|STANDARD_ERROR_OF_MEAN|2.1858||0.2485|TWO_SIDED|95.0|-1.77|6.83||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for snoring.||6.83|-1.77|0.2485
73930353|NCT01387607|147390843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.355|STANDARD_ERROR_OF_MEAN|2.265||0.2993|TWO_SIDED|95.0|-6.81|2.1||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for awaken short of breath.||2.10|-6.81|0.2993
73930354|NCT01387607|147390843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.03|STANDARD_ERROR_OF_MEAN|2.4485||0.0003|TWO_SIDED|95.0|4.21|13.85||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for sleep adequacy.||13.85|4.21|0.0003
73930355|NCT01387607|147390844|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.1114||0.0106|TWO_SIDED|95.0|0.07|0.51||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for quantity of sleep.||0.51|0.07|0.0106
73930356|NCT01387607|147390844|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.194|STANDARD_ERROR_OF_MEAN|1.6428||0.0112|TWO_SIDED|95.0|0.96|7.43||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for somnolence||7.43|0.96|0.0112
73930357|NCT01387607|147390845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.059|STANDARD_ERROR_OF_MEAN|1.6438||0.0637|TWO_SIDED|95.0|-6.29|0.18||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||||0.18|-6.29|0.0637
74029722|NCT00408421|147613970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.039||95.0|-1.69|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.05|-1.69|0.039
74029723|NCT00408421|147613971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.001||95.0|-0.56|-0.14||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.14|-0.56|0.001
74029724|NCT00408421|147613972|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06|||<|0.001||95.0|-1.66|-0.46||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.46|-1.66|<0.001
74029725|NCT00408421|147613973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.004||95.0|-1.28|-0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.24|-1.28|0.004
74029726|NCT00408421|147613974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|||<|0.001||95.0|-1.52|-0.42||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.42|-1.52|<0.001
74029727|NCT00408421|147613975|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91||||0.003||95.0|-1.5|-0.32||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.32|-1.50|0.003
74029728|NCT00408421|147613976|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.019||95.0|-1.3|-0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.12|-1.30|0.019
74029729|NCT00408421|147613977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.164||95.0|-0.97|0.17||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.17|-0.97|0.164
73863086|NCT02573246|147272021|SUPERIORITY||Mean Difference (Net)|0.631|STANDARD_ERROR_OF_MEAN|0.404||0.133|TWO_SIDED|95.0|-0.208|1.47||A priori set threshold was .05|Mixed Models Analysis|||Hypothesized that active neurostimulation will lead to less daily distress than sham neurostimulation during the ambulatory data collection. An HLM analysis was conducted using an unstructured covariance structure and reported distress right before the intervention as baseline.||1.47|-.208|.133
74029730|NCT00408421|147613978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.049||95.0|-1.25|0.0||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.00|-1.25|0.049
74029731|NCT00408421|147613979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.093||95.0|-1.1|0.08||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.08|-1.10|0.093
74088194|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.77|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.25|-0.77|0.0001
73930358|NCT01387607|147390846|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.6767|TWO_SIDED|95.0|0.67|1.87||Logistic regression model includes treatment and pooled center as factors and baseline value as covariate.|Regression, Logistic|||||1.87|0.67|0.6767
73930359|NCT01387607|147390847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.882|STANDARD_ERROR_OF_MEAN|0.1932|<|0.0001|TWO_SIDED|95.0|-1.26|-0.5||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.50|-1.26|<0.0001
73930360|NCT01387607|147390848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.172|STANDARD_ERROR_OF_MEAN|7.7785||0.0273|TWO_SIDED|95.0|-32.42|-1.92||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-1.92|-32.42|0.0273
73930361|NCT01387607|147390849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0677||0.8082|TWO_SIDED|95.0|-0.12|0.15||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||0.15|-0.12|0.8082
73930362|NCT01387607|147390850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.655|STANDARD_ERROR_OF_MEAN|0.1223|<|0.0001|TWO_SIDED|95.0|-0.89|-0.41||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.41|-0.89|<0.0001
73930363|NCT01387607|147390851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.396|STANDARD_ERROR_OF_MEAN|7.7309||0.3388|TWO_SIDED|95.0|-7.76|22.55||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||22.55|-7.76|0.3388
73930364|NCT01387607|147390852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.765|STANDARD_ERROR_OF_MEAN|0.2115||0.0003|TWO_SIDED|95.0|0.35|1.18||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||1.18|0.35|0.0003
73930365|NCT01387607|147390853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.8414||0.3186|TWO_SIDED|95.0|-2.5|0.82||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.82|-2.50|0.3186
73930366|NCT01387607|147390854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.0404||0.7149|TWO_SIDED|95.0|-1.67|2.43||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||2.43|-1.67|0.7149
73930367|NCT01387607|147390855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.785|STANDARD_ERROR_OF_MEAN|0.673||0.2442|TWO_SIDED|95.0|-0.54|2.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||2.11|-0.54|0.2442
74029732|NCT00408421|147613980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.287||95.0|-0.82|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.24|-0.82|0.287
73930368|NCT01387607|147390856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.616|STANDARD_ERROR_OF_MEAN|2.4019||0.1332|TWO_SIDED|95.0|-8.34|1.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||1.11|-8.34|0.1332
73930369|NCT01387607|147390857|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.3595||0.2934||95.0|-1.09|0.33||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.33|-1.09|0.2934
73930370|NCT01387607|147390858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.3621||0.0226|TWO_SIDED|95.0|-1.54|-0.12||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||-0.12|-1.54|0.0226
73930371|NCT03080961|147390861|OTHER||SADE percentage|0.0|||||TWO_SIDED|95.0|0.0|7.7||||||SADE rate after minimally 26 days of VIBLOK treatment will be assessed by calculating the upper limit of the 2-sided exact 95% Clopper-Pearson confidence interval which needs to be below 10%. With a sample size of 36, an exact two-sided 95.0% confidence interval for a single proportion would show that the SADE incidence is below 10% at an expected incidence of 0.1%.||7.7|0.0|
73930372|NCT03080961|147390862|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis will evaluate the difference in detection rate between pre and post-VIBLOK swabs. For each person the number of swabs with shedding only pre-VIBLOK will be assessed, and then the number of swabs with shedding only post-VIBLOK will be subtracted. A number above 0 indicates a decreased detection rate after VIBLOK. With an 8% anticipated asymptomatic shedding rate, 80% power, 50 subjects taking samples for 28 days are needed to show a 50% reduction.||||0.248
73863087|NCT02573246|147272022|SUPERIORITY||Mean Difference (Net)|-1.300772|STANDARD_ERROR_OF_MEAN|2.670936||0.629061|TWO_SIDED|95.0|-6.708548|4.107||A priori threshold was set to .05|Mixed Models Analysis|Intake values for the dependent measures were covaried. The time by condition interaction term was included.||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to less functional impairment than sham neurostimulation.||4.107|-6.708548|0.629061
73863088|NCT02573246|147272022|SUPERIORITY||Mean Difference (Net)|-0.977394|STANDARD_ERROR_OF_MEAN|2.605189||0.71|TWO_SIDED|95.0|-6.255223|4.300434|||Mixed Models Analysis|||We expected lower functional impairment in the active right versus the sham condition.||4.300434|-6.255223|0.71
73863089|NCT02573246|147272022|SUPERIORITY||Mean Difference (Net)|-3.292137|STANDARD_ERROR_OF_MEAN|3.314194||0.331|TWO_SIDED|95.0|-10.157811|3.573537||A priori set threshold was .05|Mixed Models Analysis|Baseline WSAS was covaried|The analysis compared sham versus active stimulation.|Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology in the substudy also. We expected active neurostimulation to lead to less impairment than sham neurostimulation.||3.573537|-10.157811|0.331
73863090|NCT02573246|147272022|SUPERIORITY||Mean Difference (Net)|0.284589|STANDARD_ERROR_OF_MEAN|0.276698||0.31|TWO_SIDED|95.0|-0.27603|0.845209||A priori set threshold for significance was 0.05|Mixed Models Analysis|baseline was covaried||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to more use of cognitive restructuring than sham neurostimulation.||0.845209|-0.276030|0.31
73930373|NCT03080961|147390863|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
73930374|NCT02610868|147390893|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930375|NCT02610868|147390893|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930376|NCT02610868|147390893|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930377|NCT02610868|147390893|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930378|NCT02610868|147390893|SUPERIORITY|||||||0.0006|||||||ANCOVA|||||||0.0006
73930379|NCT02610868|147390893|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930380|NCT02610868|147390893|SUPERIORITY|||||||0.1131|||||||ANCOVA|||||||0.1131
73930381|NCT02610868|147390893|SUPERIORITY|||||||0.0026|||||||ANCOVA|||||||0.0026
73930382|NCT02610868|147390893|SUPERIORITY|||||||0.2569|||||||ANCOVA|||||||0.2569
73930383|NCT02610868|147390894|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930384|NCT02610868|147390894|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930385|NCT02610868|147390894|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73863091|NCT02573246|147272022|SUPERIORITY||Mean Difference (Net)|10.129377|STANDARD_ERROR_OF_MEAN|9.150339||0.275257|TWO_SIDED|95.0|-8.394724|28.653479|||Mixed Models Analysis|||We hypothesized that active right neurostimulation would yield lower emotional dysregulation after the intervention when compared to sham neurostimulation.||28.653479|-8.394724|0.275257
73930386|NCT02610868|147390894|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930387|NCT02610868|147390894|SUPERIORITY|||||||0.313|||||||ANCOVA|||||||0.3130
73930388|NCT02610868|147390894|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73863092|NCT02573246|147272022|SUPERIORITY||Mean Difference (Net)|-13.187|STANDARD_ERROR_OF_MEAN|6.212753||0.044|TWO_SIDED|95.0|-26.002351|-0.372281||A priori set significance threshold was 0.05|Mixed Models Analysis|||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to less emotional dysregulation than sham neurostimulation.||-0.372281|-26.002351|0.044
73930389|NCT02610868|147390894|SUPERIORITY|||||||0.1054|||||||ANCOVA|||||||0.1054
73930390|NCT02610868|147390894|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
73930391|NCT02610868|147390894|SUPERIORITY|||||||0.1663|||||||ANCOVA|||||||0.1663
73930392|NCT02610868|147390896|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930393|NCT02610868|147390896|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930394|NCT02610868|147390896|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930395|NCT02610868|147390896|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930396|NCT02610868|147390896|SUPERIORITY|||||||0.11|||||||ANCOVA|||||||0.1100
73930397|NCT02610868|147390896|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930398|NCT02610868|147390896|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.0000
73930399|NCT02610868|147390896|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930400|NCT02610868|147390896|SUPERIORITY|||||||0.029|||||||ANCOVA|||||||0.0290
73930401|NCT02610868|147390897|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930402|NCT02610868|147390897|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930403|NCT02610868|147390897|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930404|NCT02610868|147390897|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930405|NCT02610868|147390897|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930406|NCT02610868|147390897|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
73930407|NCT02610868|147390897|SUPERIORITY|||||||0.9016|||||||ANCOVA|||||||0.9016
73930408|NCT02610868|147390897|SUPERIORITY|||||||0.0753|||||||ANCOVA|||||||0.0753
73930409|NCT02610868|147390897|SUPERIORITY|||||||0.4992|||||||ANCOVA|||||||0.4992
73930410|NCT02610868|147390898|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930411|NCT02610868|147390898|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930412|NCT02610868|147390898|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930413|NCT02610868|147390898|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930414|NCT02610868|147390898|SUPERIORITY|||||||0.4567|||||||ANCOVA|||||||0.4567
73930415|NCT02610868|147390898|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930416|NCT02610868|147390898|SUPERIORITY|||||||0.8115|||||||ANCOVA|||||||0.8115
73930417|NCT02610868|147390898|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930418|NCT02610868|147390898|SUPERIORITY|||||||0.3282|||||||ANCOVA|||||||0.3282
73930419|NCT02610868|147390900|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930420|NCT02610868|147390900|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930421|NCT02610868|147390900|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930422|NCT02610868|147390900|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930423|NCT02610868|147390900|SUPERIORITY|||||||0.3786|||||||ANCOVA|||||||0.3786
73930424|NCT02610868|147390900|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930425|NCT02610868|147390900|SUPERIORITY|||||||0.7787|||||||ANCOVA|||||||0.7787
73930426|NCT02610868|147390900|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73930427|NCT02610868|147390900|SUPERIORITY|||||||0.3825|||||||ANCOVA|||||||0.3825
73930428|NCT00667342|147390917|OTHER|The association between response and Ktrans at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression|||||||0.0863
73970867|NCT03532282|147481753|SUPERIORITY||coefficient beta for change trajectory|-0.15||||0.001|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.001
74029733|NCT00408421|147613981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.033||95.0|-1.23|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.05|-1.23|0.033
73930429|NCT00667342|147390918|OTHER|The association between response and Vp at Week 10 was evaluated.||||||0.0573|||||||Logistic Regression|||||||0.0573
73930430|NCT00667342|147390919|OTHER|The association between response and Ve at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression|||||||0.0863
73930431|NCT02896127|147390957|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.65|3.69|||Regression, Logistic||||"PTFU=post-treatment follow-up (12 weeks after last study treatment)~95% confidence intervals are from a score method with continuity correction."|3.69|1.65|<.0001
73930432|NCT03354429|147390971|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.015|TWO_SIDED|95.0|0.71|0.96||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Cox||Placebo is the reference group (denominator)|||0.96|0.71|0.015
73930433|NCT03354429|147390972|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.004|TWO_SIDED|95.0|0.68|0.93||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Cox||Placebo is the reference group (denominator)|||0.93|0.68|0.004
73930434|NCT03354429|147390973|SUPERIORITY||Odds Ratio (OR)|0.98||||0.613|TWO_SIDED|95.0|0.89|1.07||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Logistic|NIHSS (National Institutes of Health Stroke Scale) score and history of stroke (yes/no) included as covariates|Placebo is the reference group (denominator)|||1.07|0.89|0.613
73930435|NCT03354429|147390974|OTHER||Hazard Ratio (HR)|3.99||||0.001|TWO_SIDED|95.0|1.74|9.14|||Regression, Cox||Placebo is the reference group (denominator)|||9.14|1.74|0.001
73930436|NCT03354429|147390975|OTHER||Hazard Ratio (HR)|3.66||||0.005|TWO_SIDED|95.0|1.48|9.02|||Regression, Cox||Placebo is the reference group (denominator)|||9.02|1.48|0.005
73930437|NCT03354429|147390976|OTHER||Hazard Ratio (HR)|3.27|||<|0.001|TWO_SIDED|95.0|1.67|6.43|||Regression, Cox||Placebo is the reference group (denominator)|||6.43|1.67|<0.001
73930438|NCT03354429|147390977|OTHER||Hazard Ratio (HR)|4.8|||<|0.001|TWO_SIDED|95.0|3.28|7.02|||Regression, Cox||Placebo is the reference group (denominator)|||7.02|3.28|<0.001
73930439|NCT00494494|147391005|NON_INFERIORITY_OR_EQUIVALENCE|Our estimate of a clinically relevant increase is 25 microns. With these specifications, the sample size that is required to have 0.90 power for the comparison between two groups at the two-sided 0.05 significance level is about 10 per group.|Mean Difference (Net)|2.82|STANDARD_DEVIATION|13.8||0.7029|TWO_SIDED|95.0|-3.27|8.91|||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no correlation between the 2 groups. Standard methods were used for power calculation to determine the sample size needed to have 0.90 power for the comparison between two groups at the two-sided significance of 0.05.||8.91|-3.27|0.7029
73930440|NCT00494494|147391006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.01|STANDARD_DEVIATION|9.56||0.1937|TWO_SIDED|95.0|-2.41|6.43|||Wilcoxon (Mann-Whitney)|||||6.43|-2.41|0.1937
73930441|NCT00494494|147391007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|19.6||0.5066|TWO_SIDED|95.0|-3.12|16.52|||Wilcoxon (Mann-Whitney)|||||16.52|-3.12|0.5066
73930442|NCT00494494|147391008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.21||0.5099|TWO_SIDED|95.0|-0.13|0.227|||Wilcoxon (Mann-Whitney)|||||0.227|-0.13|0.5099
73930443|NCT00494494|147391009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|STANDARD_DEVIATION|5.64||0.5005|TWO_SIDED|95.0|-1.49|3.55|||Wilcoxon (Mann-Whitney)|||||3.55|-1.49|0.5005
73970868|NCT03532282|147481754|SUPERIORITY||coefficient beta for change trajectory|-0.01||||0.01|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.01
73970869|NCT03532282|147481755|SUPERIORITY||coefficient beta for change trajectory|-0.24||||0.0006|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.0006
73970870|NCT03532282|147481756|SUPERIORITY||coefficient beta for change trajectory|-0.04||||0.05|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.05
73970871|NCT05445427|147481795|SUPERIORITY|Groups were compared using Wilcoxon rank sum test.||||||0.544|||||||Wilcoxon (Mann-Whitney)|||||||0.544
73970872|NCT05445427|147481796|SUPERIORITY|||||||0.292|||||||ANCOVA|ANCOVA was used with the baseline value used as the covariate.||||||0.292
74029734|NCT00408421|147613982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.78||||0.015||95.0|-1.4|-0.15||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.15|-1.40|0.015
73930444|NCT02477020|147391013|SUPERIORITY_OR_OTHER||Least square mean difference|-5.46|STANDARD_ERROR_OF_MEAN|3.442||0.115|TWO_SIDED|95.0|-12.26|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM|MMRM||TAK-063 - Placebo. Baseline Positive and Negative Symptom Scale (PANSS) total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|||1.35|-12.26|0.115
73930445|NCT02477020|147391014|SUPERIORITY_OR_OTHER||Least square mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.508||0.602|TWO_SIDED|95.0|-3.77|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 1||2.19|-3.77|0.602
73930446|NCT02477020|147391014|SUPERIORITY_OR_OTHER||Least square mean difference|-2.22|STANDARD_ERROR_OF_MEAN|2.229||0.322|TWO_SIDED|95.0|-6.62|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 2||2.19|-6.62|0.322
73930447|NCT02477020|147391014|SUPERIORITY_OR_OTHER||Least square mean difference|-3.46|STANDARD_ERROR_OF_MEAN|2.813||0.221|TWO_SIDED|95.0|-9.02|2.1||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 3||2.10|-9.02|0.221
73930448|NCT02477020|147391014|SUPERIORITY_OR_OTHER||Least square mean difference|-2.11|STANDARD_ERROR_OF_MEAN|3.147||0.504|TWO_SIDED|95.0|-8.33|4.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 4||4.11|-8.33|0.504
73930449|NCT02477020|147391014|SUPERIORITY_OR_OTHER||Least square mean difference|-3.91|STANDARD_ERROR_OF_MEAN|3.231||0.229|TWO_SIDED|95.0|-10.3|2.48||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 5||2.48|-10.30|0.229
73930450|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.562||0.195|TWO_SIDED|95.0|-1.84|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 1||0.38|-1.84|0.195
73930451|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.786||0.132|TWO_SIDED|95.0|-2.74|0.36||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 2||0.36|-2.74|0.132
73930452|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-1.94|STANDARD_ERROR_OF_MEAN|0.959||0.045|TWO_SIDED|95.0|-3.84|-0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 3||-0.05|-3.84|0.045
73930453|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-1.54|STANDARD_ERROR_OF_MEAN|1.025||0.135|TWO_SIDED|95.0|-3.56|0.49||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 4||0.49|-3.56|0.135
73930454|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.09||0.067|TWO_SIDED|95.0|-4.17|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 5||0.14|-4.17|0.067
73930455|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.119||0.092|TWO_SIDED|95.0|-4.11|0.31||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 6||0.31|-4.11|0.092
73930456|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.566||0.548|TWO_SIDED|95.0|-0.78|1.46||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 1||1.46|-0.78|0.548
73930457|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.756||0.42|TWO_SIDED|95.0|-2.11|0.88||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 2||0.88|-2.11|0.420
73930458|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.818||0.857|TWO_SIDED|95.0|-1.47|1.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 3||1.76|-1.47|0.857
73930459|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.936||0.527|TWO_SIDED|95.0|-2.44|1.26||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 4||1.26|-2.44|0.527
73930460|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.94||0.875|TWO_SIDED|95.0|-2.01|1.71||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 5||1.71|-2.01|0.875
73930461|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.94||0.441|TWO_SIDED|95.0|-2.58|1.13||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 6||1.13|-2.58|0.441
73930462|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.406||0.362|TWO_SIDED|95.0|-1.17|0.43||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 1||0.43|-1.17|0.362
73930463|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.53||0.687|TWO_SIDED|95.0|-1.26|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 2||0.83|-1.26|0.687
73930464|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.618||0.458|TWO_SIDED|95.0|-1.68|0.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 3||0.76|-1.68|0.458
73930465|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.704||0.991|TWO_SIDED|95.0|-1.38|1.4||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 4||1.40|-1.38|0.991
74029735|NCT00408421|147613983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.029||95.0|-1.06|-0.06||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.06|-1.06|0.029
74029736|NCT00408421|147613984|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.||||0.033
74029737|NCT00408421|147613985|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.||||0.075
74088195|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.06|-0.5|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.50|-1.06|<.0001
73930466|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.782||0.354|TWO_SIDED|95.0|-2.27|0.82||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 5||0.82|-2.27|0.354
73930467|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.804||0.119|TWO_SIDED|95.0|-2.85|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 6||0.33|-2.85|0.119
73930468|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.469||0.493|TWO_SIDED|95.0|-1.25|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 1||0.60|-1.25|0.493
73930469|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.504||0.949|TWO_SIDED|95.0|-0.96|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 2||1.03|-0.96|0.949
73930470|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.604||0.153|TWO_SIDED|95.0|-2.06|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 3||0.33|-2.06|0.153
73930471|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.681||0.994|TWO_SIDED|95.0|-1.34|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 4||1.35|-1.34|0.994
73930472|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.679||0.365|TWO_SIDED|95.0|-1.96|0.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 5||0.73|-1.96|0.365
73930473|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.653||0.088|TWO_SIDED|95.0|-2.41|0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 6||0.17|-2.41|0.088
73930474|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.397||0.535|TWO_SIDED|95.0|-0.54|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 1||1.03|-0.54|0.535
73930475|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.502||0.412|TWO_SIDED|95.0|-1.4|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 2||0.58|-1.40|0.412
73930476|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.522||0.354|TWO_SIDED|95.0|-1.52|0.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 3||0.55|-1.52|0.354
73930477|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.59||0.589|TWO_SIDED|95.0|-1.49|0.85||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 4||0.85|-1.49|0.589
73930478|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.569||0.36|TWO_SIDED|95.0|-1.65|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 5||0.60|-1.65|0.360
73930479|NCT02477020|147391015|SUPERIORITY_OR_OTHER||Least square mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.635||0.288|TWO_SIDED|95.0|-1.93|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 6||0.58|-1.93|0.288
73930480|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.59||0.238|TWO_SIDED|95.0|-1.87|0.47||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 1||0.47|-1.87|0.238
74029738|NCT00408421|147613986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83||||0.088||95.0|-0.28|3.94||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.94|-0.28|0.088
73930481|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.784||0.359|TWO_SIDED|95.0|-2.27|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 2||0.83|-2.27|0.359
73930482|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.943||0.119|TWO_SIDED|95.0|-3.34|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 3||0.38|-3.34|0.119
73930483|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.014||0.238|TWO_SIDED|95.0|-3.21|0.8||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 4||0.80|-3.21|0.238
73930484|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-1.73|STANDARD_ERROR_OF_MEAN|1.051||0.102|TWO_SIDED|95.0|-3.81|0.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 5||0.35|-3.81|0.102
73930485|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.094||0.145|TWO_SIDED|95.0|-3.77|0.56||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 6||0.56|-3.77|0.145
73930486|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.504||0.902|TWO_SIDED|95.0|-0.93|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 1||1.06|-0.93|0.902
73930487|NCT02477020|147391016|SUPERIORITY_OR_OTHER||MMRM|-0.59|STANDARD_ERROR_OF_MEAN|0.693||0.396|TWO_SIDED|95.0|-1.96|0.78||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 2||0.78|-1.96|0.396
73930488|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.722||0.612|TWO_SIDED|95.0|-1.79|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 3||1.06|-1.79|0.612
73930489|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.856||0.67|TWO_SIDED|95.0|-2.06|1.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 4||1.33|-2.06|0.670
73930490|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.892||0.807|TWO_SIDED|95.0|-1.98|1.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 5||1.55|-1.98|0.807
73930491|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-1.14|STANDARD_ERROR_OF_MEAN|0.853||0.182|TWO_SIDED|95.0|-2.83|0.54||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 6||0.54|-2.83|0.182
74088196|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0006|TWO_SIDED|95.0|-0.77|-0.21|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.21|-0.77|0.0006
73930492|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.801||0.933|TWO_SIDED|95.0|-1.52|1.65||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 1||1.65|-1.52|0.933
74088197|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.2|-0.62|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.62|-1.20|<.0001
73930493|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.61|STANDARD_ERROR_OF_MEAN|1.151||0.596|TWO_SIDED|95.0|-2.89|1.66||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 2||1.66|-2.89|0.596
73930494|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-1.31|STANDARD_ERROR_OF_MEAN|1.455||0.371|TWO_SIDED|95.0|-4.18|1.57||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 3||1.57|-4.18|0.371
73930495|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|1.625||0.821|TWO_SIDED|95.0|-3.58|2.84||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 4||2.84|-3.58|0.821
73930496|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-1.61|STANDARD_ERROR_OF_MEAN|1.621||0.323|TWO_SIDED|95.0|-4.81|1.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 5||1.60|-4.81|0.323
73930497|NCT02477020|147391016|SUPERIORITY_OR_OTHER||Least square mean difference|-2.44|STANDARD_ERROR_OF_MEAN|1.732||0.161|TWO_SIDED|95.0|-5.87|0.98||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 6||0.98|-5.87|0.161
73930498|NCT02477020|147391017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.664||||0.017|TWO_SIDED|95.0|1.263|10.624|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 1||10.624|1.263|0.017
73930499|NCT02477020|147391017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.782||||0.009|TWO_SIDED|95.0|1.287|6.014|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 2||6.014|1.287|0.009
73930500|NCT02477020|147391017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.818||||0.108|TWO_SIDED|95.0|0.877|3.771|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 3||3.771|0.877|0.108
73930501|NCT02477020|147391017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.222||||0.596|TWO_SIDED|95.0|0.583|2.561|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 4||2.561|0.583|0.596
73930502|NCT02477020|147391017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.542||||0.263|TWO_SIDED|95.0|0.722|3.292|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 5||3.292|0.722|0.263
73930503|NCT02477020|147391017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.253||95.0|0.725|3.388|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 6||3.388|0.725|0.253
73930504|NCT02477020|147391018|SUPERIORITY_OR_OTHER||Least square mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.095||0.619|TWO_SIDED|95.0|-0.23|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 1||0.14|-0.23|0.619
73930505|NCT02477020|147391018|SUPERIORITY_OR_OTHER||Least square mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.136||0.116|TWO_SIDED|95.0|-0.48|0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 2||0.05|-0.48|0.116
73930506|NCT02477020|147391018|SUPERIORITY_OR_OTHER||Least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.166||0.009|TWO_SIDED|95.0|-0.77|-0.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 3||-0.11|-0.77|0.009
73930507|NCT02477020|147391018|SUPERIORITY_OR_OTHER||Least square mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.049|TWO_SIDED|95.0|-0.72|0.0||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 4||0.00|-0.72|0.049
73930508|NCT02477020|147391018|SUPERIORITY_OR_OTHER||Least square mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.191||0.016|TWO_SIDED|95.0|-0.85|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 5||-0.09|-0.85|0.016
73930509|NCT02477020|147391018|SUPERIORITY_OR_OTHER||Least square mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.202||0.035||95.0|-0.83|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 6||-0.03|-0.83|0.035
73930510|NCT02477020|147391019|SUPERIORITY_OR_OTHER||Least square mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.128||0.746|TWO_SIDED|95.0|-0.29|0.21||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 1||0.21|-0.29|0.746
74029739|NCT00408421|147613987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.87||||0.08||95.0|-0.22|3.96||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.96|-0.22|0.080
73930511|NCT02477020|147391019|SUPERIORITY_OR_OTHER||Least mean square difference|-0.37|STANDARD_ERROR_OF_MEAN|0.173||0.034|TWO_SIDED|95.0|-0.72|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 2||-0.03|-0.72|0.034
73930512|NCT02477020|147391019|SUPERIORITY_OR_OTHER||Least square mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.203||0.006|TWO_SIDED|95.0|-0.97|-0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 3||-0.17|-0.97|0.006
73930513|NCT02477020|147391019|SUPERIORITY_OR_OTHER||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.22||0.013|TWO_SIDED|95.0|-0.99|-0.12||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 4||-0.12|-0.99|0.013
73930514|NCT02477020|147391019|SUPERIORITY_OR_OTHER||Least mean square difference|-0.56|STANDARD_ERROR_OF_MEAN|0.238||0.02|TWO_SIDED|95.0|-1.03|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 5||-0.09|-1.03|0.020
73930515|NCT02477020|147391019|SUPERIORITY_OR_OTHER||Least square mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.244||0.007|TWO_SIDED|95.0|-1.15|-0.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 6||-0.18|-1.15|0.007
73930516|NCT02477020|147391020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.726||||0.077|TWO_SIDED|95.0|0.899|8.267||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 1||8.267|0.899|0.077
73930517|NCT02477020|147391020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.331||||0.036|TWO_SIDED|95.0|1.055|5.153||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 2||5.153|1.055|0.036
73930518|NCT02477020|147391020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69||||0.015|TWO_SIDED|95.0|1.208|5.99||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 3||5.990|1.208|0.015
73930519|NCT02477020|147391020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.737||||0.158|TWO_SIDED|95.0|0.807|3.735||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 4||3.735|0.807|0.158
73930520|NCT02477020|147391020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.739||||0.164|TWO_SIDED|95.0|0.798|3.789||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 5||3.789|0.798|0.164
73930521|NCT02477020|147391020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44||||0.003|TWO_SIDED|95.0|1.523|7.77||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 6||7.770|1.523|0.003
73930522|NCT02477020|147391021|SUPERIORITY_OR_OTHER||Least square mean difference|1.8|STANDARD_ERROR_OF_MEAN|1.547||0.246|TWO_SIDED|95.0|-1.26|4.86||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 3||4.86|-1.26|0.246
73930523|NCT02477020|147391021|SUPERIORITY_OR_OTHER||Least square mean difference|2.2|STANDARD_ERROR_OF_MEAN|1.767||0.216|TWO_SIDED|95.0|-1.3|5.69||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|Least square mean difference||TAK-063 - Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction|Change at Week 6||5.69|-1.30|0.216
73930524|NCT02477020|147391022|SUPERIORITY_OR_OTHER||Least mean square difference|-0.38|STANDARD_ERROR_OF_MEAN|1.664||0.82|TWO_SIDED|95.0|-3.67|2.91||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BNSS total score-by-week interaction.|Change at Week 3||2.91|-3.67|0.820
73930525|NCT02477020|147391022|SUPERIORITY_OR_OTHER||Least square mean difference|-2.87|STANDARD_ERROR_OF_MEAN|2.05||0.163|TWO_SIDED|95.0|-6.93|1.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 6||1.18|-6.93|0.163
73930526|NCT02477020|147391023|SUPERIORITY_OR_OTHER||Least square mean difference|2.69|STANDARD_ERROR_OF_MEAN|1.769||0.131|TWO_SIDED|95.0|-0.81|6.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 3||6.19|-0.81|0.131
73930527|NCT02477020|147391023|SUPERIORITY_OR_OTHER||Least square mean difference|2.62|STANDARD_ERROR_OF_MEAN|2.313||0.26|TWO_SIDED|95.0|-1.96|7.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 6||7.19|-1.96|0.260
73930528|NCT02477020|147391024|SUPERIORITY_OR_OTHER||Least square mean difference|0.06|STANDARD_ERROR_OF_MEAN|1.855||0.973|TWO_SIDED|95.0|-3.61|3.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 3||3.73|-3.61|0.973
73930529|NCT02477020|147391024|SUPERIORITY_OR_OTHER||Least mean square difference|-0.54|STANDARD_ERROR_OF_MEAN|2.255||0.812|TWO_SIDED|95.0|-5.0|3.92||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 6||3.92|-5.00|0.812
73930530|NCT03523117|147391062|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.3108|TWO_SIDED||||||ANCOVA|||||||0.3108
73930531|NCT03523117|147391063|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
74029740|NCT00408421|147613988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||<|0.001||95.0|0.03|0.1||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.10|0.03|<0.001
74029741|NCT00408421|147613989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.641||95.0|-1.19|0.74||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.74|-1.19|0.641
74029742|NCT00408421|147613990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.193||95.0|-1.17|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.24|-1.17|0.193
74029743|NCT00408421|147613991|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||||0.003
73930532|NCT03523117|147391064|SUPERIORITY||Mean Difference (Final Values)|15.64||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
73930533|NCT03523117|147391065|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0002|TWO_SIDED||||||Mixed Models Analysis|||||||0.0002
73930534|NCT00835497|147391126|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|86.5||||||90.0|81.8|91.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||91.6|81.8|
73930535|NCT00835497|147391127|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.9|94.2|
73930536|NCT00835497|147391128|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.8|94.2|
73930537|NCT00835497|147391129|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|88.9||||||90.0|83.5|94.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||94.6|83.5|
73930538|NCT00835497|147391130|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|88.4|97.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.1|88.4|
74029744|NCT00408421|147613992|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||||0.026
74029745|NCT00408421|147613993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.459||95.0|-1.32|2.92||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||2.92|-1.32|0.459
74029746|NCT00408421|147613994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.326||95.0|-1.1|3.28||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.28|-1.10|0.326
73930539|NCT00835497|147391131|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|88.8|97.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.5|88.8|
73930540|NCT00554749|147391136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.09|STANDARD_DEVIATION|0.43|<|0.001||95.0|1.69|2.49|||paired t-test|Paired t-test of SSQ at baseline vs at 6 months, degrees of freedom=6. Difference in SSQ is reported.||||2.49|1.69|<0.001
73930541|NCT03417141|147391138|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Week 12||||0.014
73930542|NCT03417141|147391138|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Week 24||||0.006
73930543|NCT03417141|147391139|SUPERIORITY|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
73930544|NCT03417141|147391140|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
73930545|NCT03417141|147391141|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
73930546|NCT03706690|147391151|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.038|TWO_SIDED|95.0|0.578|0.986|||Log Rank|Analysis performed using stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs sCRT).||The hazard ratio and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for the level of programmed death ligand 1 (PD-L1) expression (PD-L1 \<1% versus \[vs\] PD-L1 \>=1%) and prior therapy (concurrent \[c\]CRT vs sequential \[s\]CRT), with treatment as the only covariate and ties handled by Efron approach.||0.986|0.578|0.038
73930547|NCT03706690|147391152|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.346|TWO_SIDED|95.0|0.656|1.166|||Log Rank|Analysis performed using stratified log-rank test, adjusting for level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1 \>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.166|0.656|0.346
73930548|NCT03706690|147391152|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.346|TWO_SIDED|95.0|0.663|1.162|||Log Rank|Analysis performed using stratified log-rank test, adjusting for level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1 \>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.162|0.663|0.346
73930549|NCT03706690|147391153|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.026|TWO_SIDED|95.0|0.575|0.966|||Log Rank|Analysis performed using stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs sCRT).||The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1\>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||0.966|0.575|0.026
73930550|NCT03706690|147391155|SUPERIORITY||Odds Ratio (OR)|1.51||||0.128|TWO_SIDED|95.0|0.891|2.607|||Regression, Logistic|||For mITT set. The comparison was performed using a logistic regression model, with treatment as a covariate and adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with 95% CI calculated by profile likelihood.||2.607|0.891|0.128
74029747|NCT00408421|147613995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.16||||0.069||95.0|-0.25|6.56||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||6.56|-0.25|0.069
74029748|NCT00408421|147613996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.107||95.0|-1.2|0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.12|-1.20|0.107
73863093|NCT02573246|147272022|SUPERIORITY||Mean Difference (Net)|0.927909|STANDARD_ERROR_OF_MEAN|9.603423||0.924|TWO_SIDED|95.0|-18.508252|20.364071||A priori set threshold for statistical significance was 0.05|Mixed Models Analysis|baseline was covaried||We expected active stimulation to lead to less emotional dysregulation than sham neurostimulation. A MMANOVA model was employed, controlling for baseline.||20.364071|-18.508252|.924
73930551|NCT03706690|147391155|SUPERIORITY||Odds Ratio (OR)|1.54||||0.105|TWO_SIDED|95.0|0.915|2.638|||Regression, Logistic|||For ITT set. The comparison was performed using a logistic regression model, with treatment as a covariate and adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with 95% CI calculated by profile likelihood.||2.638|0.915|0.105
73930552|NCT03706690|147391158|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.275|TWO_SIDED|95.0|0.648|1.138|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.138|0.648|0.275
73930553|NCT03706690|147391158|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.241|TWO_SIDED|95.0|0.648|1.122|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.122|0.648|0.241
73930554|NCT03706690|147391159|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.769|TWO_SIDED|95.0|0.726|1.578|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.578|0.726|0.769
73930555|NCT03706690|147391159|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.812|TWO_SIDED|95.0|0.726|1.539|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.539|0.726|0.812
74029749|NCT02772965|147613997|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.08|TWO_SIDED|95.0|0.45|1.05|||Log Rank|||||1.05|0.45|0.08
74029750|NCT02772965|147613998|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.4||0.32|TWO_SIDED||||||Mixed Models Analysis|||||||0.32
74029751|NCT02772965|147613999|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.8||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
74029752|NCT02772965|147614000|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.6||0.72|TWO_SIDED||||||Mixed Models Analysis|||||||0.72
74029753|NCT02772965|147614001|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|1.9||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
74029754|NCT02772965|147614002|SUPERIORITY||Risk Ratio (RR)|0.71||||0.08|TWO_SIDED|95.0|0.49|1.04|||Chi-squared|||||1.04|0.49|0.08
74029755|NCT03478878|147614014|SUPERIORITY||Mean Difference (Final Values)|1.83||||0.705|TWO_SIDED|95.0|-9.43|13.11||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 2 for Cohort 1)."||13.11|-9.43|0.705
74029756|NCT03478878|147614014|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.577|TWO_SIDED|95.0|-27.43|31.02||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 1 for Cohort 2)."||31.02|-27.43|0.577
74029757|NCT03478878|147614015|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.646|TWO_SIDED|95.0|-7.6|11.35||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 3 for Cohort 1)."||11.35|-7.60|0.646
74029758|NCT03478878|147614015|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.405|TWO_SIDED|95.0|-19.3|23.9||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 2 for Cohort 2)."||23.90|-19.30|0.405
73863094|NCT02573246|147272022|SUPERIORITY||Mean Difference (Net)|-0.017547|STANDARD_ERROR_OF_MEAN|0.267983||0.95|TWO_SIDED|95.0|-0.560994|0.525901|||Mixed Models Analysis|||we expected more use of cr following active right neurostimulation then after following sham neurostimulation.||0.525901|-0.560994|.95
73863095|NCT02573246|147272022|SUPERIORITY||Mean Difference (Net)|-0.096719|STANDARD_ERROR_OF_MEAN|0.389897||0.806|TWO_SIDED|95.0|-0.900919|0.707481||A priori set significance threshold was 0.05|Mixed Models Analysis|Baseline use of cognitive restructuring was covaried||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to more use of cognitive restructuring than sham neurostimulation.||0.707481|-0.900919|.806
73863096|NCT02968914|147272098|SUPERIORITY||Geometric mean ratio (%)|94.46|||||TWO_SIDED|90.0|88.16|101.21|||ANOVA|||||101.21|88.16|
73863097|NCT02968914|147272099|SUPERIORITY||Geometric mean ratio (%)|92.83|||||TWO_SIDED|90.0|87.41|98.58|||ANOVA|||||98.58|87.41|
73863098|NCT02968914|147272100|SUPERIORITY||Geometric mean ratio (%)|92.34|||||TWO_SIDED|90.0|86.34|98.75|||ANOVA|||||98.75|86.34|
73863099|NCT04468074|147272115|SUPERIORITY||Mean Difference (Net)|1.0||||0.014|TWO_SIDED||||||Mixed Models Analysis|||||||0.014
73863100|NCT04468074|147272116|SUPERIORITY||Mean Difference (Net)|2.79||||0.0159|TWO_SIDED||||||Mixed Models Analysis|||||||0.0159
73930556|NCT03385239|147391186|SUPERIORITY||Mean Difference in % CFB|-27.0||||0.0042|TWO_SIDED|95.0|-41.0|-10.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-10|-41|0.0042
73930557|NCT03385239|147391186|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-48.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-48|-66|<0.0001
73930558|NCT03385239|147391186|SUPERIORITY||Mean Difference in % CFB|-63.0|||<|0.0001|TWO_SIDED|95.0|-70.0|-54.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-54|-70|<0.0001
73930559|NCT03385239|147391186|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-69.0|-53.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-53|-69|<0.0001
73863101|NCT04468074|147272117|SUPERIORITY||Median Difference (Net)|-3.85||||0.0066|TWO_SIDED||||||Mixed Models Analysis|||||||0.0066
73863102|NCT00249613|147272141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.34||0.01|TWO_SIDED|95.0|0.21|0.79||Odds ratio is 0.40, confidence interval is 0.21-0.79.|Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only participants are less likely than Mixed-Gender participants to engage in criminal activities.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.||0.79|0.21|0.01
73863103|NCT00249613|147272142|SUPERIORITY_OR_OTHER||Beta coefficient|-0.7|STANDARD_ERROR_OF_MEAN|0.72||0.33|TWO_SIDED|95.0|-2.11|0.7|||Generalized estimating equations (GEE)|||Generalized estimating equation (GEE) models do not separate arms: group status (women-only vs mixed-gender) is the dependent variable. Because we were not able to randomly assign, we also included a propensity score, and additional variables (education, race/ethnicity, marital status, income, history of sexual abuse, criminal justice funding source, had child, mental health symptoms, and a time in treatment by group interaction term) to adjust for the non-random sampling.||0.70|-2.11|0.33
73863104|NCT00249613|147272143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42|STANDARD_ERROR_OF_MEAN|0.34||0.01|TWO_SIDED|95.0|0.22|0.82|||Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only treatment participants are less likely than the Mixed-Gender group to use drugs or alcohol during the 30 days prior to the 12-Mo follow-up.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.||0.82|0.22|0.01
73863105|NCT00424190|147272144|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10%.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.2|6.2|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.||6.2|-4.2|
73930560|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-30.0||||0.0123|TWO_SIDED|95.0|-47.0|-8.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoC III||-8|-47|0.0123
73930561|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-68.0|||<|0.0001|TWO_SIDED|95.0|-76.0|-58.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-58|-76|<0.0001
73930562|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-74.0|||<|0.0001|TWO_SIDED|95.0|-80.0|-65.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-65|-80|<0.0001
73863106|NCT01672866|147272152|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|-0.2|||||TWO_SIDED|95.0|-1.3|1.0||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||1.0|-1.3|
73863107|NCT01672866|147272152|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|-0.4|||||TWO_SIDED|95.0|-1.5|0.8||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||0.8|-1.5|
73863108|NCT01672866|147272153|SUPERIORITY|||||||0.73|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.||||0.73
73863109|NCT01672866|147272153|SUPERIORITY|||||||0.85|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.||||0.85
73930563|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-74.0|||<|0.0001|TWO_SIDED|95.0|-80.0|-66.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-66|-80|<0.0001
73930564|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.568|TWO_SIDED|95.0|-11.0|7.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||7|-11|0.568
73930565|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-12.0||||0.008|TWO_SIDED|95.0|-19.0|-3.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-3|-19|0.008
73930566|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.4476|TWO_SIDED|95.0|-12.0|6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||6|-12|0.4476
73930567|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.0606|TWO_SIDED|95.0|-16.0|0.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||0|-16|0.0606
73930568|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|7.0||||0.4509|TWO_SIDED|95.0|-10.0|26.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||26|-10|0.4509
73930569|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|4.0||||0.6746|TWO_SIDED|95.0|-12.0|23.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||23|-12|0.6746
73930570|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|29.0||||0.0032|TWO_SIDED|95.0|9.0|53.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||53|9|0.0032
74029759|NCT03151148|147614031|SUPERIORITY||Risk Ratio (RR)|0.56||||0.075|TWO_SIDED|95.0|0.29|1.06|||Negative Binomial Regression|Negative binomial generalized linear model, adjusting for site, offset by follow-up days within the outcome measure time frame|TMT represents the numerator, placebo represents the denominator|||1.06|0.29|0.075
73863110|NCT00424268|147272154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|80.0|STANDARD_ERROR_OF_MEAN|15.0|<|0.0001|TWO_SIDED|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||110|51|<0.0001
73863111|NCT00424268|147272155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.0|STANDARD_ERROR_OF_MEAN|15.0|<|0.0001|TWO_SIDED|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||110|51|<0.0001
73930571|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|12.0||||0.1996|TWO_SIDED|95.0|-6.0|32.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||32|-6|0.1996
73863112|NCT00424268|147272156|SUPERIORITY_OR_OTHER||Rate ratio|0.768|STANDARD_ERROR_OF_MEAN|0.157||0.1957|TWO_SIDED|95.0|0.515|1.146||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||1.146|0.515|0.1957
73930572|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|12.0||||0.0373|TWO_SIDED|95.0|1.0|24.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||24|1|0.0373
73930573|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|34.0|||<|0.0001|TWO_SIDED|95.0|21.0|49.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||49|21|<0.0001
73930574|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|42.0|||<|0.0001|TWO_SIDED|95.0|28.0|57.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||57|28|<0.0001
73930575|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|30.0|||<|0.0001|TWO_SIDED|95.0|18.0|44.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||44|18|<0.0001
73930576|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.2826|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||6|-18|0.2826
74029760|NCT03151148|147614032|SUPERIORITY||Risk Difference (RD)|-0.28||||0.044|TWO_SIDED|95.0|-0.51|-0.04|||Chi-squared||95% exact unconditional confidence interval is based on the Santner and Snell method|||-0.04|-0.51|0.044
74029761|NCT03151148|147614033|SUPERIORITY||Risk Ratio (RR)|0.63||||0.121|TWO_SIDED|95.0|0.36|1.13|||Negative Binomial Regression|Negative binomial generalized linear model, adjusting for site, offset by follow-up days within the outcome measure time frame|TMT represents the numerator, placebo represents the denominator|||1.13|0.36|0.121
74029762|NCT03151148|147614034|SUPERIORITY||Risk Difference (RD)|-0.25||||0.053|TWO_SIDED|95.0|-0.46|-0.04|||Chi-squared||95% exact unconditional confidence interval is based on the Santner and Snell method|||-0.04|-0.46|0.053
73863113|NCT00424268|147272157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0032|TWO_SIDED|95.0|0.1|0.7||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||0.7|0.1|0.0032
73863114|NCT00424268|147272158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|0.9||0.0051|TWO_SIDED|95.0|-4.5|-0.8||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||-0.8|-4.5|0.0051
73863115|NCT01378429|147272159|NON_INFERIORITY_OR_EQUIVALENCE|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.|LS Mean Difference|7.6|||||TWO_SIDED|95.0|-7.4|22.6||\<0.025 for a one-sided test.|ANCOVA||Difference is calculated as Placebo - Ciclesonide.|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.||22.6|-7.4|
73863116|NCT02033213|147272210|SUPERIORITY_OR_OTHER|||||||0.41||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.||||0.410
73863117|NCT02033213|147272210|SUPERIORITY_OR_OTHER|||||||0.621||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.621
73863118|NCT02033213|147272211|SUPERIORITY_OR_OTHER|||||||0.791||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.||||0.791
73863119|NCT02033213|147272211|SUPERIORITY_OR_OTHER|||||||0.41||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.410
73863120|NCT02033213|147272212|SUPERIORITY_OR_OTHER|||||||0.322||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement aws assessed at 10 minutes time point.||||0.322
73863121|NCT02033213|147272212|SUPERIORITY_OR_OTHER|||||||0.574||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.574
74029763|NCT03151148|147614039|SUPERIORITY||Geometric mean ratio (GMR)|2.76||||0.261|TWO_SIDED|95.0|0.469|16.226|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||16.226|0.469|0.261
74088198|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.06|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.47|-1.06|<.0001
74088199|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.2|-0.59|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.59|-1.20|<.0001
73863122|NCT02033213|147272213|SUPERIORITY_OR_OTHER|||||||0.03||||||P \< 0.05 was considered significant.|t-test, 1 sided|||||||0.030
73863123|NCT02033213|147272213|SUPERIORITY_OR_OTHER|||||||0.096||||||P \< 0.05 was considered significant.|t-test, 1 sided|||||||0.096
73863124|NCT02033213|147272214|SUPERIORITY_OR_OTHER|||||||0.362|||||||t-test, 1 sided|||||||0.362
73863125|NCT02033213|147272215|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.020
73863126|NCT03449433|147272225|SUPERIORITY||Ratio of LS Means|1.04|||||TWO_SIDED|95.0|0.985|1.1||||||||1.10|0.985|
73863127|NCT01345682|147272227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.792||||0.0257|TWO_SIDED|95.0|0.643|0.977||Log-rank test stratified by baseline Eastern Cooperative Oncology Group (ECOG) Performance score (PS)(0 or 1) and prior use of Epidermal Growth Factor Receptor (EGFR)-targeted antibody in the Recurrent and/or Metastatic (R/M) setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.977|0.643|0.0257
73863128|NCT01345682|147272228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958||||0.6755|TWO_SIDED|95.0|0.786|1.169||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||1.169|0.786|0.6755
73863129|NCT01345682|147272229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.101|TWO_SIDED|95.0|0.88|4.14|||Regression, Logistic||"Odds ratio, 95% Confidence Interval (CI) and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||4.14|0.88|0.1010
73863130|NCT01345682|147272230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0353|TWO_SIDED|95.0|1.03|2.26|||Regression, Logistic||"Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||2.26|1.03|0.0353
74029764|NCT03151148|147614039|SUPERIORITY||Geometric mean ratio (GMR)|0.41||||0.319|TWO_SIDED|95.0|0.069|2.393|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.393|0.069|0.319
74029765|NCT03151148|147614039|SUPERIORITY||Geometric mean ratio (GMR)|1.02||||0.978|TWO_SIDED|95.0|0.174|6.027|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.027|0.174|0.978
74088200|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.64|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.64|-1.25|<.0001
74088201|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.16||0.0001|TWO_SIDED|95.0|-0.93|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.30|-0.93|0.0001
73930577|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-24.0|||<|0.0001|TWO_SIDED|95.0|-34.0|-14.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-14|-34|<0.0001
74029766|NCT03151148|147614039|SUPERIORITY||Geometric mean ratio (GMR)|3.44||||0.177|TWO_SIDED|95.0|0.57|20.749|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||20.749|0.570|0.177
74029767|NCT03151148|147614039|SUPERIORITY||Geometric mean ratio (GMR)|1.7||||0.558|TWO_SIDED|95.0|0.288|9.973|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.973|0.288|0.558
73930578|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-15.0||||0.0118|TWO_SIDED|95.0|-26.0|-4.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-4|-26|0.0118
74029768|NCT03151148|147614039|SUPERIORITY||Geometric mean ratio (GMR)|1.04||||0.977|TWO_SIDED|95.0|0.082|13.151|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.151|0.082|0.977
74088202|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.13|-0.5|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.50|-1.13|<.0001
73930579|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-20.0||||0.0009|TWO_SIDED|95.0|-29.0|-9.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-29|0.0009
74029769|NCT03151148|147614039|SUPERIORITY||Geometric mean ratio (GMR)|33.86||||0.007|TWO_SIDED|95.0|2.672|429.219|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||429.219|2.672|0.007
73930580|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-21.0||||0.0086|TWO_SIDED|95.0|-34.0|-6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-6|-34|0.0086
73930581|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-53.0|||<|0.0001|TWO_SIDED|95.0|-60.0|-44.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-44|-60|<0.0001
73930582|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-64.0|-50.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-50|-64|<0.0001
73930583|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-60.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-52.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-52|-66|<0.0001
73930584|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|2.0||||0.6801|TWO_SIDED|95.0|-7.0|13.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||13|-7|0.6801
73930585|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-16.0||||0.0007|TWO_SIDED|95.0|-24.0|-7.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||-7|-24|0.0007
73930586|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-5.0||||0.3183|TWO_SIDED|95.0|-14.0|5.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||5|-14|0.3183
73930587|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.024|TWO_SIDED|95.0|-19.0|-1.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||-1|-19|0.024
73970873|NCT06074172|147481811|OTHER|Linear Mixed Models were done with a compound symmetry covariance structure. This infers that the variances (pooled within-group) and covariances (across subjects) of all of the repeated measures are homogenous.||||||0.008||||||In the Bonferroni corrected Linear Mixed Model for PI Ratio, the p-value for the following interaction was reported: Treatment\*Age.|Linear Mixed Model|"Linear Mixed Model analyses:~1. Factor: Treatment group~2. Covariates: Age, Sex, CBD Use history, and Urine THC~3. Interactions"||||||0.008
73970874|NCT04005794|147481815|OTHER|||||||0.004||||||Social latency t = 3.215|t-test, 2 sided|||||||0.004
74088203|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.39|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.39|-1.05|<.0001
73930588|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|5.0||||0.0936|TWO_SIDED|95.0|-1.0|11.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||11|-1|0.0936
73930589|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|14.0|||<|0.0001|TWO_SIDED|95.0|8.0|21.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||21|8|<0.0001
73930590|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|18.0|||<|0.0001|TWO_SIDED|95.0|11.0|25.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||25|11|<0.0001
73930591|NCT03385239|147391188|SUPERIORITY||Mean Difference in % CFB|14.0|||<|0.0001|TWO_SIDED|95.0|7.0|20.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||20|7|<0.0001
73930592|NCT03385239|147391189|SUPERIORITY||Odds Ratio (OR)|3.34||||0.2591|TWO_SIDED|95.0|0.41|27.2|||Regression, Logistic|||||27.20|0.41|0.2591
73930593|NCT03385239|147391189|SUPERIORITY||Odds Ratio (OR)|84.02|||<|0.0001|TWO_SIDED|95.0|9.54|740.02|||Regression, Logistic|||||740.02|9.54|<0.0001
73930594|NCT03385239|147391189|SUPERIORITY||Odds Ratio (OR)|322.79|||<|0.0001|TWO_SIDED|95.0|20.31|5130.99|||Regression, Logistic|||||5130.99|20.31|<0.0001
73930595|NCT03385239|147391189|SUPERIORITY||Odds Ratio (OR)|342.13|||<|0.0001|TWO_SIDED|95.0|23.72|4933.89|||Regression, Logistic|||||4933.89|23.72|<0.0001
73930596|NCT03385239|147391190|SUPERIORITY||Odds Ratio (OR)|1.25||||0.9119|TWO_SIDED|95.0|0.02|69.88|||Regression, Logistic|||||69.88|0.02|0.9119
73930597|NCT03385239|147391190|SUPERIORITY||Odds Ratio (OR)|27.18||||0.0306|TWO_SIDED|95.0|1.36|542.48|||Regression, Logistic|||||542.48|1.36|0.0306
73930598|NCT03385239|147391190|SUPERIORITY||Odds Ratio (OR)|25.54||||0.0344|TWO_SIDED|95.0|1.27|514.2|||Regression, Logistic|||||514.20|1.27|0.0344
73930599|NCT03385239|147391190|SUPERIORITY||Odds Ratio (OR)|44.47||||0.0123|TWO_SIDED|95.0|2.28|866.49|||Regression, Logistic|||||866.49|2.28|0.0123
73930600|NCT01574703|147391194|SUPERIORITY_OR_OTHER|||||||0.37||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.37
73930601|NCT01574703|147391195|SUPERIORITY_OR_OTHER|||||||0.53||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.53
73930602|NCT01574703|147391196|SUPERIORITY_OR_OTHER|||||||0.34||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.34
73970875|NCT04005794|147481816|OTHER|||||||0.213|||||||ANOVA|||||||0.213
73970876|NCT04005794|147481817|OTHER|||||||0.01|||||||ANOVA|||||||0.01
73970877|NCT04005794|147481818|OTHER|||||||0.004|||||||ANOVA|||||||0.004
73970878|NCT04005794|147481819|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73970879|NCT04447469|147481842|SUPERIORITY||Odds Ratio (OR)|2.069||||0.2598|TWO_SIDED|95.0|0.555|8.615||P-value and odds ratio were calculated using Fisher's Exact test.|Fisher Exact|||||8.615|0.555|0.2598
73970880|NCT04447469|147481842|SUPERIORITY||Odds Ratio (OR)|2.414||||0.161|TWO_SIDED|95.0|0.653|9.957||P-value and odds ratio were calculated using Fisher's Exact test.|Fisher Exact|||||9.957|0.653|0.1610
73970881|NCT04447469|147481842|SUPERIORITY||Stratified Odds Ratio|2.091||||0.2448|TWO_SIDED|95.0|0.612|7.144||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||7.144|0.612|0.2448
74029770|NCT03151148|147614039|SUPERIORITY||Geometric mean ratio (GMR)|11.97||||0.055|TWO_SIDED|95.0|0.945|151.752|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||151.752|0.945|0.055
73930603|NCT01574703|147391197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.49||||0.8375|TWO_SIDED|95.0|-5.22|4.23||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||4.23|-5.22|0.8375
73930604|NCT01574703|147391197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.978|TWO_SIDED|95.0|-5.2|5.05||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||5.05|-5.20|0.9780
73930605|NCT01574703|147391197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.13||||0.6142|TWO_SIDED|95.0|-5.54|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||3.27|-5.54|0.6142
73930606|NCT01574703|147391197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.42||||0.8602|TWO_SIDED|95.0|-4.28|5.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||5.13|-4.28|0.8602
73930607|NCT01574703|147391197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.64||||0.7217|TWO_SIDED|95.0|-4.15|2.88||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.88|-4.15|0.7217
73930608|NCT01574703|147391197|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.06||||0.6322|TWO_SIDED|95.0|-5.41|3.28||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.28|-5.41|0.6322
73930609|NCT01574703|147391198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.9687|TWO_SIDED|95.0|-3.48|3.34||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||3.34|-3.48|0.9687
73930610|NCT01574703|147391198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.56||||0.7905|TWO_SIDED|95.0|-3.58|4.7||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||4.70|-3.58|0.7905
73930611|NCT01574703|147391198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.8962|TWO_SIDED|95.0|-3.36|2.94||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.94|-3.36|0.8962
73930612|NCT01574703|147391198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.63||||0.7767|TWO_SIDED|95.0|-3.72|4.98||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||4.98|-3.72|0.7767
73930613|NCT01574703|147391198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14||||0.926|TWO_SIDED|95.0|-3.13|2.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.85|-3.13|0.9260
73930614|NCT01574703|147391198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.77||||0.7113|TWO_SIDED|95.0|-4.85|3.31||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.31|-4.85|0.7113
73930615|NCT01574703|147391199|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.57||||0.8117|TWO_SIDED|95.0|-5.27|4.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||4.13|-5.27|0.8117
73930616|NCT01574703|147391199|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.78||||0.7303|TWO_SIDED|95.0|-5.21|3.65||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||3.65|-5.21|0.7303
73930617|NCT01574703|147391199|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.2||||0.5946|TWO_SIDED|95.0|-5.6|3.21||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||3.21|-5.60|0.5946
73930618|NCT01574703|147391199|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.92|TWO_SIDED|95.0|-4.27|3.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||3.85|-4.27|0.9200
73970882|NCT04447469|147481842|SUPERIORITY||Stratified Odds Ratio|2.749||||0.1378|TWO_SIDED|95.0|0.756|9.993||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||9.993|0.756|0.1378
73930619|NCT01574703|147391199|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.62||||0.7236|TWO_SIDED|95.0|-4.09|2.84||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.84|-4.09|0.7236
73930620|NCT01574703|147391199|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.42||||0.8201|TWO_SIDED|95.0|-4.01|3.17||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.17|-4.01|0.8201
73930621|NCT01574703|147391200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.8932|TWO_SIDED|95.0|-3.22|2.81||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||2.81|-3.22|0.8932
73930622|NCT01574703|147391200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.23||||0.8747|TWO_SIDED|95.0|-3.09|2.63||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||2.63|-3.09|0.8747
73970883|NCT04447469|147481843|SUPERIORITY||Stratified Odds Ratio|1.231||||0.4534|TWO_SIDED|95.0|0.715|2.12||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||2.120|0.715|0.4534
73970884|NCT04447469|147481843|SUPERIORITY||Stratified Odds Ratio|1.097||||0.7414|TWO_SIDED|95.0|0.636|1.891||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.891|0.636|0.7414
73970885|NCT04447469|147481844|SUPERIORITY||Odds Ratio (OR)|0.984||||1|TWO_SIDED|95.0|0.198|4.884|||Fisher Exact|||||4.884|0.198|1.0000
74088204|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.1|-0.44|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.44|-1.10|<.0001
74088205|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.06|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.39|-1.06|<.0001
73930623|NCT01574703|147391200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.671|TWO_SIDED|95.0|-3.35|2.15||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.15|-3.35|0.6710
73930624|NCT01574703|147391200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.9886|TWO_SIDED|95.0|-3.32|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||3.27|-3.32|0.9886
73970886|NCT04447469|147481844|SUPERIORITY||Odds Ratio (OR)|1.286||||1|TWO_SIDED|95.0|0.26|6.417|||Fisher Exact|||||6.417|0.260|1.0000
73970887|NCT04447469|147481845|SUPERIORITY||Difference in Proportion|-15.0|||||TWO_SIDED|95.0|-45.6|15.6|||||95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - placebo.|||15.6|-45.6|
73970888|NCT04447469|147481845|SUPERIORITY||Difference in Proportions|-27.7|||||TWO_SIDED|95.0|-56.4|0.9|||||95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - Placebo .|||0.9|-56.4|
73970889|NCT04447469|147481846|SUPERIORITY|||||||0.6229||||||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank|||||||0.6229
73970890|NCT04447469|147481846|SUPERIORITY|||||||0.5526||||||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank|||||||0.5526
73970891|NCT04447469|147481847|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9426|TWO_SIDED|80.0|0.71|1.46||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|||1.46|0.71|0.9426
73970892|NCT04447469|147481847|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.6838|TWO_SIDED|80.0|0.78|1.57||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|||1.57|0.78|0.6838
73970893|NCT04447469|147481848|SUPERIORITY||Odds Ratio (OR)|0.235||||0.0905|TWO_SIDED|95.0|0.023|1.328|||Fisher Exact|||||1.328|0.023|0.0905
73970894|NCT04447469|147481848|SUPERIORITY||Odds Ratio (OR)|0.431||||0.2247|TWO_SIDED|95.0|0.087|1.815|||Fisher Exact|||||1.815|0.087|0.2247
73970895|NCT04447469|147481848|SUPERIORITY||Stratified Odds Ratio|0.191||||0.0623|TWO_SIDED|95.0|0.033|1.114||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||1.114|0.033|0.0623
73970896|NCT04447469|147481848|SUPERIORITY||Stratified Odds Ratio|0.368||||0.1957|TWO_SIDED|95.0|0.085|1.583||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||1.583|0.085|0.1957
73930625|NCT01574703|147391200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.39||||0.7631|TWO_SIDED|95.0|-2.92|2.14||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.14|-2.92|0.7631
73930626|NCT01574703|147391200|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.37||||0.8022|TWO_SIDED|95.0|-3.23|2.5||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.50|-3.23|0.8022
73930627|NCT01574703|147391201|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.91||||0.6441|TWO_SIDED|95.0|-4.78|2.96||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||2.96|-4.78|0.6441
73930628|NCT01574703|147391201|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.69||||0.7327|TWO_SIDED|95.0|-4.63|3.26||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||3.26|-4.63|0.7327
73930629|NCT01574703|147391201|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.99||||0.6109|TWO_SIDED|95.0|-4.8|2.82||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.82|-4.80|0.6109
73930630|NCT01574703|147391201|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.22||||0.8707|TWO_SIDED|95.0|-2.48|2.93||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||2.93|-2.48|0.8707
73930631|NCT01574703|147391201|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.9531|TWO_SIDED|95.0|-2.63|2.48||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.48|-2.63|0.9531
73930632|NCT01574703|147391201|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3||||0.8262|TWO_SIDED|95.0|-2.99|2.39||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.39|-2.99|0.8262
73930633|NCT01574703|147391202|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.59||||0.6105|TWO_SIDED|95.0|-2.84|1.67||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||1.67|-2.84|0.6105
73930634|NCT01574703|147391202|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.32||||0.7895|TWO_SIDED|95.0|-2.65|2.01||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||2.01|-2.65|0.7895
73970897|NCT04447469|147481849|SUPERIORITY||Hazard Ratio (HR)|1.57||||0.3766|TWO_SIDED|80.0|0.8|3.09||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).|||3.09|0.80|0.3766
73930635|NCT01574703|147391202|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.48||||0.6804|TWO_SIDED|95.0|-2.75|1.8||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||1.80|-2.75|0.6804
73970898|NCT04447469|147481849|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9209|TWO_SIDED|80.0|0.51|2.16||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).|||2.16|0.51|0.9209
73970899|NCT04447469|147481850|SUPERIORITY||Stratified Odds Ratio|0.645||||0.1772|TWO_SIDED|95.0|0.34|1.222||Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.222|0.340|0.1772
73970900|NCT04447469|147481850|SUPERIORITY||Stratified Odds Ratio|1.029||||0.9269|TWO_SIDED|95.0|0.563|1.881||Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.881|0.563|0.9269
73970901|NCT04447469|147481851|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9578|TWO_SIDED|95.0|0.66|1.49||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).|||1.49|0.66|0.9578
73970902|NCT04447469|147481851|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5274|TWO_SIDED|95.0|0.76|1.7||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).|||1.70|0.76|0.5274
73970903|NCT04447469|147481852|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.1336|TWO_SIDED|95.0|0.36|1.15||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age, and ARDS status).|||1.15|0.36|0.1336
73970904|NCT04447469|147481852|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9767|TWO_SIDED|95.0|0.59|1.72||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata ( age, and ARDS status).|||1.72|0.59|0.9767
73930636|NCT01574703|147391202|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.27||||0.8127|TWO_SIDED|95.0|-1.95|2.49||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||2.49|-1.95|0.8127
73930637|NCT01574703|147391202|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11||||0.9218|TWO_SIDED|95.0|-2.04|2.25||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.25|-2.04|0.9218
73930638|NCT01574703|147391202|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.16||||0.8841|TWO_SIDED|95.0|-2.32|2.0||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.00|-2.32|0.8841
73930639|NCT03467425|147391206|SUPERIORITY||Odds Ratio (OR)|1.31|||<|0.001|TWO_SIDED|95.0|1.13|1.51||Analysis was performed using logistic regression model with covariates of treatment group, Baseline CAT score, number of exacerbations in the prior year, actual prior medication use strata and country.|Regression, Logistic||Statistical comparison is presented for combined data of responders, non-responders and those with imputed CAT score at Week 24.|||1.51|1.13|<0.001
73930640|NCT03467425|147391207|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.0121|<|0.001|TWO_SIDED|95.0|0.026|0.073|||ANCOVA||Analysis was performed using an ANCOVA with covariates of treatment group, Baseline FEV1, actual prior medication use strata, country and timing of spirometry.|||0.073|0.026|<0.001
73930641|NCT03467425|147391208|SUPERIORITY||Odds Ratio (OR)|1.99||||0.103|TWO_SIDED|95.0|0.87|4.53|||Regression, Logistic||Analysis was performed using logistic regression model with covariates of treatment group, actual prior medication use strata and country.|||4.53|0.87|0.103
73930642|NCT02318693|147391209|SUPERIORITY_OR_OTHER||LS Means Difference|-8.8||||0.245|TWO_SIDED|95.0|-23.8|6.2|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||6.2|-23.8|0.245
73930643|NCT02318693|147391210|SUPERIORITY_OR_OTHER||LS Means Difference|-5.9||||0.029|TWO_SIDED|95.0|-11.3|-0.6|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.6|-11.3|0.029
73970905|NCT04447469|147481853|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.55|3.71|||||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).|||3.71|0.55|
73970906|NCT04447469|147481853|SUPERIORITY||Hazard Ratio (HR)|1.88|||||TWO_SIDED|95.0|0.78|4.54|||||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).|||4.54|0.78|
73970907|NCT02714257|147481854|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.43|TWO_SIDED|95.0|0.74|1.14|||Regression, Cox||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.14|0.74|0.43
73930644|NCT02318693|147391211|SUPERIORITY_OR_OTHER||LS Means Difference|-12.8||||0.041|TWO_SIDED|95.0|-25.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Breakfast. The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.5|-25.1|0.041
73930645|NCT02318693|147391211|SUPERIORITY_OR_OTHER||LS Means Difference|-14.3||||0.043|TWO_SIDED|95.0|-28.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Lunch. The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.5|-28.1|0.043
73970908|NCT02714257|147481855|SUPERIORITY||Incidence Rate Ratio|1.06||||0.5|TWO_SIDED|95.0|0.89|1.28|||Regression, Negative Binomial||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.28|0.89|0.50
73970909|NCT02714257|147481856|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3|TWO_SIDED|95.0|0.72|1.11|||Regression, Logistic|||||1.11|0.72|0.30
73970910|NCT02714257|147481857|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.01|TWO_SIDED|95.0|0.16|0.92|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.92|0.16|<0.01
73970911|NCT02714257|147481858|SUPERIORITY||Odds Ratio (OR)|1.04||||0.73|TWO_SIDED|95.0|0.85|1.27|||Regression, Logistic||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.27|0.85|0.73
73970912|NCT02714257|147481859|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.27|TWO_SIDED|95.0|-0.18|0.62|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.62|-0.18|0.27
73970913|NCT02714257|147481860|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.37|TWO_SIDED|95.0|-0.13|0.34|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.34|-0.13|0.37
73970914|NCT02714257|147481861|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.26|TWO_SIDED|95.0|-0.1|0.38|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.38|-0.10|0.26
73970915|NCT02714257|147481862|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.39|TWO_SIDED|95.0|-0.09|0.22|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.22|-0.09|0.39
73970916|NCT05825755|147481863|SUPERIORITY|||||||0.252|||||||Wilcoxon (Mann-Whitney)|||||||0.252
73970917|NCT05825755|147481864|SUPERIORITY|||||||1|||||||McNemar|||||||1.0
73970918|NCT05825755|147481865|SUPERIORITY|||||||0.791|||||||Wilcoxon (Mann-Whitney)|||||||0.791
73930646|NCT02318693|147391211|SUPERIORITY_OR_OTHER||LS Means Difference|5.1||||0.509|TWO_SIDED|95.0|-10.3|20.4|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Dinner. The comparison was conducted at the α=0.05 (2-sided) significance level.||20.4|-10.3|0.509
73930647|NCT02318693|147391212|SUPERIORITY_OR_OTHER||LS Means Difference|15.7||||0.02|TWO_SIDED|95.0|2.5|28.8|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||28.8|2.5|0.020
73930648|NCT02318693|147391213|SUPERIORITY_OR_OTHER||LS Means Difference|-1.1||||0.134|TWO_SIDED|95.0|-2.5|0.3|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 70 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.3|-2.5|0.134
73930649|NCT02318693|147391213|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6||||0.226|TWO_SIDED|95.0|-1.5|0.4|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 60 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.4|-1.5|0.226
73930650|NCT02318693|147391213|SUPERIORITY_OR_OTHER||LS Means Difference|0.0||||0.332|TWO_SIDED|95.0|-0.1|0.0|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 50 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.0|-0.1|0.332
73930651|NCT02026115|147391217|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||.43
73930652|NCT02026115|147391218|SUPERIORITY|||||||0.02||||||Experimental group performed worse than usual care.|Mixed Models Analysis|||||||.02
73930653|NCT02026115|147391219|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||.32
73930654|NCT02026115|147391220|SUPERIORITY|||||||0.36|||||||Regression, Logistic|||||||.36
73930655|NCT02026115|147391221|SUPERIORITY|||||||0.01|||||||Regression, Linear|||||||.01
73930656|NCT02026115|147391222|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
73930657|NCT03238911|147391283|SUPERIORITY||Risk Difference (RD)|-67.0|||<|0.0001|TWO_SIDED|95.0|-77.4|-51.5|||Cochran-Mantel-Haenszel||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."||-51.5|-77.4|<0.0001
73930658|NCT03238911|147391284|SUPERIORITY|||||||0.8979|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan-Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) \<2 mg/dL were included.||||0.8979
73930659|NCT03238911|147391285|SUPERIORITY||Risk Difference (RD)|-39.2|||<|0.0001|TWO_SIDED|95.0|-52.2|-23.3|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose will be compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (\< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.||-23.3|-52.2|<0.0001
73930660|NCT03238911|147391286|SUPERIORITY||Mean Difference (Final Values)|0.48|||<|0.0001|TWO_SIDED|95.0|0.31|0.65|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.65|0.31|<0.0001
73930661|NCT03238911|147391286|SUPERIORITY||Mean Difference (Final Values)|1.06|||<|0.0001|TWO_SIDED|95.0|0.85|1.27|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.27|0.85|<0.0001
73930662|NCT03238911|147391286|SUPERIORITY||Mean Difference (Final Values)|1.03|||<|0.0001|TWO_SIDED|95.0|0.81|1.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.25|0.81|<0.0001
73930663|NCT03238911|147391286|SUPERIORITY||Mean Difference (Final Values)|1.35|||<|0.0001|TWO_SIDED|95.0|1.1|1.6|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.60|1.10|<0.0001
73930664|NCT03238911|147391286|SUPERIORITY||Mean Difference (Final Values)|1.03|||<|0.0001|TWO_SIDED|95.0|0.75|1.32|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.32|0.75|<0.0001
73930665|NCT03238911|147391286|SUPERIORITY||Mean Difference (Final Values)|1.13|||<|0.0001|TWO_SIDED|95.0|0.86|1.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.39|0.86|<0.0001
73930666|NCT03238911|147391287|SUPERIORITY||Mean Difference (Final Values)|15.55|||<|0.0001|TWO_SIDED|95.0|10.32|20.79|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||20.79|10.32|<0.0001
73930667|NCT03238911|147391287|SUPERIORITY||Mean Difference (Final Values)|33.23|||<|0.0001|TWO_SIDED|95.0|26.62|39.84|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||39.84|26.62|<0.0001
73930668|NCT03238911|147391287|SUPERIORITY||Mean Difference (Final Values)|32.78|||<|0.0001|TWO_SIDED|95.0|25.71|39.84|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||39.84|25.71|<0.0001
73930669|NCT03238911|147391287|SUPERIORITY||Mean Difference (Final Values)|42.11|||<|0.0001|TWO_SIDED|95.0|33.89|50.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||50.32|33.89|<0.0001
73930670|NCT03238911|147391287|SUPERIORITY||Mean Difference (Final Values)|32.28|||<|0.0001|TWO_SIDED|95.0|23.09|41.48|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||41.48|23.09|<0.0001
73930671|NCT03238911|147391287|SUPERIORITY||Mean Difference (Final Values)|36.06|||<|0.0001|TWO_SIDED|95.0|27.33|44.78|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||44.78|27.33|<0.0001
73930672|NCT03238911|147391289|SUPERIORITY||Mean Difference (Final Values)|-105.74|||<|0.0001|TWO_SIDED|95.0|-131.04|-80.45|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-80.45|-131.04|<0.0001
73930673|NCT03238911|147391289|SUPERIORITY||Mean Difference (Final Values)|-60.76|||<|0.0001|TWO_SIDED|95.0|-82.95|-38.58|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-38.58|-82.95|<0.0001
73930674|NCT03238911|147391289|SUPERIORITY||Mean Difference (Final Values)|-293.23|||<|0.0001|TWO_SIDED|95.0|-368.15|-218.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-218.30|-368.15|<0.0001
73930675|NCT03238911|147391289|SUPERIORITY||Mean Difference (Final Values)|-117.47|||<|0.0001|TWO_SIDED|95.0|-151.6|-83.33|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-83.33|-151.60|<0.0001
73930676|NCT03238911|147391289|SUPERIORITY||Mean Difference (Final Values)|-71.21|||<|0.0001|TWO_SIDED|95.0|-101.8|-40.61|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-40.61|-101.80|<0.0001
74088206|NCT02709486|147729982|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.13|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.46|-1.13|<.0001
73930677|NCT03238911|147391289|SUPERIORITY||Mean Difference (Final Values)|-37.16|||<|0.0001|TWO_SIDED|95.0|-54.92|-19.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-19.39|-54.92|<0.0001
73930678|NCT03238911|147391290|SUPERIORITY||Mean Difference (Final Values)|-99.1|||<|0.0001|TWO_SIDED|95.0|-136.42|-61.76|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-61.76|-136.42|<0.0001
73930679|NCT03238911|147391290|SUPERIORITY||Mean Difference (Final Values)|-49.3|||<|0.0001|TWO_SIDED|95.0|-72.8|-25.9|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-25.90|-72.80|<0.0001
73930680|NCT03238911|147391290|SUPERIORITY||Mean Difference (Final Values)|-191.3|||<|0.0001|TWO_SIDED|95.0|-242.47|-140.09|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-140.09|-242.47|<0.0001
73930681|NCT03238911|147391290|SUPERIORITY||Mean Difference (Final Values)|-100.7|||<|0.0001|TWO_SIDED|95.0|-137.19|-64.2|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-64.20|-137.19|<0.0001
73930682|NCT03238911|147391290|SUPERIORITY||Mean Difference (Final Values)|-48.4|||<|0.0001|TWO_SIDED|95.0|-71.78|-24.96|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-24.96|-71.78|<0.0001
73930683|NCT03238911|147391290|SUPERIORITY||Mean Difference (Final Values)|-15.0||||0.1411|TWO_SIDED|95.0|-35.04|5.06|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||5.06|-35.04|0.1411
73930684|NCT03238911|147391291|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.562|TWO_SIDED|95.0|-1.08|0.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.59|-1.08|0.5620
73930685|NCT03238911|147391291|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.0126|TWO_SIDED|95.0|0.38|3.12|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.12|0.38|0.0126
73930686|NCT03238911|147391291|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.608|TWO_SIDED|95.0|-1.19|2.02|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.02|-1.19|0.6080
73931102|NCT02652624|147391989|NON_INFERIORITY|A sample size of 470 participants (\~235 participants per treatment group) would provide at least 87% power to detect a non-inferiority margin of 4% difference in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the 2 treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in percentages|0.0|||||TWO_SIDED|95.001|-2.9|2.9|||||The difference in percentages between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.||2.9|-2.9|
73931103|NCT02652624|147391989|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73931104|NCT02652624|147391990|NON_INFERIORITY|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.001% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in percentages|0.4|||||TWO_SIDED|95.001|-3.7|4.5|||||The difference in percentages between treatment groups and their 95.001% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||4.5|-3.7|
73931105|NCT02652624|147391990|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73931106|NCT02652624|147391991|OTHER||Difference in least square means|3.0||||0.84|TWO_SIDED|95.0|-27.0|34.0|||ANOVA||Difference in least squares means and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.|||34|-27|0.84
73931107|NCT00739336|147391994|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Piecewise linear multilevel models with multiple observations nested within each participant were used. Random components (intercept, slope) were introduced into the model to account for dependence among measurements within a participant and assessed by nested model comparisons using the deviance statistic (difference in -2LL).||||<0.01
73931108|NCT01448850|147392036|SUPERIORITY_OR_OTHER||Rate ratio|0.92||||0.645|TWO_SIDED|90.0|0.68|1.25||Data was analyzed using Poisson regression with Pearson correction, adjusting for treatment, background therapy and history of previous exacerbations.|Poisson regression|||||1.25|0.68|0.645
73931109|NCT01420302|147392056|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73931110|NCT04304001|147392070|SUPERIORITY||||||<|0.05|||||||Chi-squared|||For each arm, the proportion of participants who receive colorectal cancer screening by 12 months was computed. The chi-square test was used to compare the two treatment arms for screening receipt. If the proportion of participants receiving colorectal cancer screening in the intervention arm is at least 15% higher than that in the control arm, the intervention was determined to be effective.||||<0.05
73931111|NCT04304001|147392071|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Bivariate analyses was conducted for the knowledge scale to compare differences between the intervention and control arms. Since knowledge was a continuous variable,the values between study arms were compared using two-sample independent t-tests.||||<0.05
73931112|NCT04304001|147392072|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Bivariate analyses was conducted for the self-efficacy scale to compare differences between the intervention and control arms. Since self-efficacy was a continuous variable, the values between study arms were compared using two-sample independent t-tests.||||<0.05
73931113|NCT04875520|147392073|NON_INFERIORITY|Overall rate compared using GEE model includes any person affiliated with the school who tested positive at least once during the study period that the schools reported to us that were positive. This includes people in our testing program and not in our testing program.|Mean Difference (Final Values)|-0.01845||||0.25|TWO_SIDED|95.0|-0.04981|0.01292|||generalized estimating equations|||||0.01292|-0.04981|0.25
73931114|NCT05773287|147392095|SUPERIORITY|||||||0.509||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.509
73931115|NCT05773287|147392096|SUPERIORITY|||||||0.552||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.552
73931116|NCT01109316|147392117|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.48|||||TWO_SIDED|95.0|0.2|0.76|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age stratum + Baseline HbA1c.|This was the primary gated analysis.||0.76|0.20|
73931117|NCT01109316|147392118|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.22|||||TWO_SIDED|95.0|-0.07|0.52|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.|||0.52|-0.07|
73931118|NCT01109316|147392118|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.25|||||TWO_SIDED|95.0|-0.05|0.56|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.|||0.56|-0.05|
73931119|NCT01109316|147392119|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|||||TWO_SIDED|95.0|-0.29|0.51|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.51|-0.29|
73931120|NCT01109316|147392119|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|||||TWO_SIDED|95.0|-0.41|0.73|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.73|-0.41|
73931121|NCT01109316|147392119|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.03|||||TWO_SIDED|95.0|-0.18|0.24|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.24|-0.18|
74008090|NCT02137512|147566420|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
73931122|NCT01109316|147392119|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.56|0.27|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.27|-0.56|
73931123|NCT01109316|147392119|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|||||TWO_SIDED|95.0|-0.48|0.6|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.60|-0.48|
73931124|NCT01109316|147392119|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.85|0.65|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.65|-0.85|
73931125|NCT01109316|147392120|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|||||TWO_SIDED|95.0|-0.02|0.14|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.|||0.14|-0.02|
73931126|NCT01109316|147392120|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.09|||||TWO_SIDED|95.0|0.01|0.18|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.|||0.18|0.01|
73931127|NCT01109316|147392121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.5|1.75|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.75|0.50|
73931128|NCT01109316|147392121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.29|1.67|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.|||1.67|0.29|
73931129|NCT01109316|147392121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.56|1.41|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.41|0.56|
73931130|NCT01109316|147392121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.66|1.64|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.|||1.64|0.66|
73971450|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-178.789|||<|0.0001|TWO_SIDED|95.0|-204.899|-152.678|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-152.678|-204.899|<.0001
73971451|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-184.391|||<|0.0001|TWO_SIDED|95.0|-211.184|-157.598|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-157.598|-211.184|<.0001
73931131|NCT01109316|147392122|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||1.00
73931132|NCT01109316|147392123|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test|||||||0.164
73931133|NCT01109316|147392123|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test|||||||0.185
73931134|NCT01109316|147392124|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.736
73931135|NCT01109316|147392124|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.006
73931136|NCT01109316|147392124|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||1.00
73931137|NCT01109316|147392124|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.017
73931138|NCT01109316|147392125|SUPERIORITY_OR_OTHER|||||||0.471||95.0||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.471
73931139|NCT01109316|147392125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||<0.001
73931140|NCT01109316|147392125|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.737
73931141|NCT01109316|147392125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||<0.001
73931142|NCT01109316|147392127|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.006
73931143|NCT01109316|147392127|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.002
73931144|NCT01109316|147392128|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model|||||||0.060
73931145|NCT01109316|147392128|SUPERIORITY_OR_OTHER|||||||0.486||95.0||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model|||||||0.486
73931146|NCT01109316|147392129|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model|||||||0.056
73931147|NCT01109316|147392129|SUPERIORITY_OR_OTHER|||||||0.805||95.0||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model|||||||0.805
73931148|NCT01109316|147392129|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model|||||||0.020
73931149|NCT01109316|147392129|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model|||||||0.051
73931150|NCT00094653|147392153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0004|TWO_SIDED|95.0|0.55|0.85|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.85|0.55|0.0004
73931151|NCT00094653|147392154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.0026|TWO_SIDED|95.0|0.51|0.87|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.87|0.51|0.0026
73931152|NCT00094653|147392154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.7575|TWO_SIDED|95.0|0.83|1.3|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.30|0.83|0.7575
73931153|NCT00094653|147392156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.00|0.66|
73931154|NCT00094653|147392156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.83|0.50|
73931155|NCT00094653|147392156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.53|1.01|
73931156|NCT00094653|147392158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.00|0.66|
73931157|NCT00094653|147392158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.83|0.50|
73931158|NCT00094653|147392158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.53|1.01|
73931159|NCT00094653|147392160|SUPERIORITY_OR_OTHER|||||||0.0433||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0433
73931160|NCT00094653|147392160|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0012
73931161|NCT00094653|147392160|SUPERIORITY_OR_OTHER|||||||0.0402||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0402
73931162|NCT00094653|147392163|SUPERIORITY_OR_OTHER|||||||0.0179||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0179
73931163|NCT00094653|147392163|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0002
73931164|NCT00094653|147392163|SUPERIORITY_OR_OTHER|||||||0.0429||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0429
73931165|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.2805|TWO_SIDED|95.0|-2.5|8.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||8.6|-2.5|0.2805
73931166|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.63|TWO_SIDED|95.0|-5.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||8.2|-5.0|0.6300
73931167|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.6026|TWO_SIDED|95.0|-3.9|6.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||6.8|-3.9|0.6026
73931168|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.1219|TWO_SIDED|95.0|-1.1|8.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||8.9|-1.1|0.1219
73931169|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0||||0.0978|TWO_SIDED|95.0|-0.9|11.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||11.0|-0.9|0.0978
73931170|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.659|TWO_SIDED|95.0|-6.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||3.8|-6.0|0.6590
73931171|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.248|TWO_SIDED|95.0|-3.0|11.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||11.7|-3.0|0.2480
73931172|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.4742|TWO_SIDED|95.0|-5.6|12.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||12.0|-5.6|0.4742
73931173|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.7597|TWO_SIDED|95.0|-6.1|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||8.3|-6.1|0.7597
73931174|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.9119|TWO_SIDED|95.0|-4.7|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||5.2|-4.7|0.9119
73931175|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.7616|TWO_SIDED|95.0|-6.9|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||5.0|-6.9|0.7616
73931176|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.6266|TWO_SIDED|95.0|-3.6|6.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||6.0|-3.6|0.6266
73931177|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9984|TWO_SIDED|95.0|-4.8|4.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||4.8|-4.8|0.9984
73931178|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.4873|TWO_SIDED|95.0|-7.8|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||3.7|-7.8|0.4873
73931179|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.3938|TWO_SIDED|95.0|-2.7|6.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||6.7|-2.7|0.3938
73931180|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.6695|TWO_SIDED|95.0|-8.1|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||5.2|-8.1|0.6695
73931181|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.4041|TWO_SIDED|95.0|-11.3|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||4.6|-11.3|0.4041
73931182|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.5538|TWO_SIDED|95.0|-4.5|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||8.3|-4.5|0.5538
74008091|NCT02137512|147566420|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008092|NCT02137512|147566420|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74091596|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.29|||||TWO_SIDED|95.0|1.99|9.25|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 6A||9.25|1.99|
74091597|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|5.49|||||TWO_SIDED|95.0|2.53|11.91|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 6A||11.91|2.53|
73931183|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.2259|TWO_SIDED|95.0|-10.3|2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||2.4|-10.3|0.2259
73931184|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.6168|TWO_SIDED|95.0|-9.6|5.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||5.7|-9.6|0.6168
73931185|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.5329|TWO_SIDED|95.0|-8.2|4.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||4.3|-8.2|0.5329
73931186|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9397|TWO_SIDED|95.0|-4.7|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||5.0|-4.7|0.9397
73931187|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.6716|TWO_SIDED|95.0|-7.1|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||4.6|-7.1|0.6716
73931188|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.5497|TWO_SIDED|95.0|-3.3|6.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||6.2|-3.3|0.5497
73931189|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3||||0.0625|TWO_SIDED|95.0|-12.8|0.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||0.3|-12.8|0.0625
73931190|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.3214|TWO_SIDED|95.0|-11.9|3.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||3.9|-11.9|0.3214
73931191|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.4898|TWO_SIDED|95.0|-8.7|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||4.2|-8.7|0.4898
73971452|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-175.1|||<|0.0001|TWO_SIDED|95.0|-200.964|-149.237|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-149.237|-200.964|<.0001
73931192|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.0761|TWO_SIDED|95.0|-11.8|0.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||0.6|-11.8|0.0761
73931193|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.3187|TWO_SIDED|95.0|-11.2|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||3.7|-11.2|0.3187
73971453|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-161.576|||<|0.0001|TWO_SIDED|95.0|-187.543|-135.609|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-135.609|-187.543|<.0001
74029781|NCT03151148|147614041|SUPERIORITY||Geometric mean ratio (GMR)|0.895||||0.953|TWO_SIDED|95.0|0.0219|36.5559|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||36.5559|0.0219|0.953
73931194|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.5548|TWO_SIDED|95.0|-7.9|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||4.2|-7.9|0.5548
73931195|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.245|TWO_SIDED|95.0|-12.1|3.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline||3.1|-12.1|0.2450
73931196|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8464|TWO_SIDED|95.0|-10.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline||8.2|-10.0|0.8464
73931197|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.3351|TWO_SIDED|95.0|-10.9|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep Disturbance change from baseline||3.7|-10.9|0.3351
73931198|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.6291|TWO_SIDED|95.0|-9.1|5.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite loss change from baseline||5.5|-9.1|0.6291
73931199|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.7675|TWO_SIDED|95.0|-7.4|10.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline||10.1|-7.4|0.7675
73931200|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.3911|TWO_SIDED|95.0|-10.2|4.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline||4.0|-10.2|0.3911
73931201|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0431|TWO_SIDED|95.0|-12.9|-0.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||-0.2|-12.9|0.0431
73971454|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-172.983|||<|0.0001|TWO_SIDED|95.0|-192.08|-153.886|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-153.886|-192.080|<.0001
73971455|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-3.585||||0.7781|TWO_SIDED|95.0|-28.572|21.401|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||21.401|-28.572|0.7781
73931202|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.0101|TWO_SIDED|95.0|-17.4|-2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||-2.4|-17.4|0.0101
73931203|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.2796|TWO_SIDED|95.0|-2.8|9.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||9.5|-2.8|0.2796
73931204|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.194|TWO_SIDED|95.0|-2.2|10.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||10.8|-2.2|0.1940
73931205|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||0.0821|TWO_SIDED|95.0|-0.9|14.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||14.8|-0.9|0.0821
73863249|NCT01325714|147272750|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.71||||0.13|TWO_SIDED|95.0|0.45|1.11||This is the p value from the discrete-time Cox regression time-to-event analyses|Regression, Cox|DF = 1|The enhanced usual care arm is the comparison group.|"Univariate time-to-event analyses, using discrete-time Cox regression models to evaluate differences between PAVeD and EU-PC in the primary outcome of incidence of aggression over time.~We expected that patients with dementia among dyads randomized to PAVeD arm would be less likely to develop aggression compared to those randomized to the enhanced usual care arm."||1.11|0.45|0.13
73931206|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.4169|TWO_SIDED|95.0|-9.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||3.8|-9.0|0.4169
73931207|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.5717|TWO_SIDED|95.0|-7.5|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||4.2|-7.5|0.5717
73931208|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.6949|TWO_SIDED|95.0|-5.6|8.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||8.4|-5.6|0.6949
73931209|NCT00094653|147392165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.2849|TWO_SIDED|95.0|-8.8|2.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||2.6|-8.8|0.2849
73931210|NCT00330551|147392224|SUPERIORITY||t-test|0.77|||=|0.05|TWO_SIDED|95.0|0.483|1.058|||t-test, 2 sided||||t(80)=5.3, p\<.001|1.058|0.483|=.05
73931211|NCT00330551|147392225|SUPERIORITY||Risk Difference (RD)|11.1|||=|0.001|TWO_SIDED||||||Chi-squared|||||||=.001
73931212|NCT00330551|147392226|SUPERIORITY||||||=|0.83|||||||Chi-squared|||||||=.83
73931213|NCT00330551|147392227|SUPERIORITY||||||=|0.2|||||||ANOVA|||A priori hypothesis was that long-acting injectible risperidone would lead to greater duration of work/school attendance than oral risperidone.||||=.20
73863250|NCT01325714|147272750|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.77||||0.39|TWO_SIDED|95.0|0.43|1.39||From discrete time-cox regression time-to-event analysis.|Regression, Cox|df = 1|The enhanced usual care arm is the reference group.|Comparison of incidence of non-verbal aggression between treatment groups.||1.39|0.43|0.39
73931214|NCT00330551|147392228|SUPERIORITY|||||||0.71|||||||ANOVA|||||||.71
73931215|NCT00330551|147392229|SUPERIORITY||||||=|0.57|||||||ANOVA|||||||=.57
74008093|NCT02137512|147566421|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
73931216|NCT00330551|147392231|SUPERIORITY||||||<|0.16|||||||ANOVA|||||||<.16
73931217|NCT00330551|147392232|SUPERIORITY||||||=|0.41|||||||ANOVA|||||||=.41
73931218|NCT01339390|147392287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3941|STANDARD_ERROR_OF_MEAN|0.5759||0.4937|TWO_SIDED|95.0|-0.7347|1.5229||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 12 months, comparing the change in weight from 12 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups||1.5229|-.7347|0.4937
73931219|NCT01339390|147392287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5893|STANDARD_ERROR_OF_MEAN|0.5759||0.3062|TWO_SIDED|95.0|-0.5395|1.7181||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 24 months, comparing the change in weight from 24 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups||1.7181|-0.5395|0.3062
73931220|NCT04847674|147392288|OTHER||LS mean difference|-0.027||||0.7914|TWO_SIDED|95.0|-0.2276|0.174|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1740|-0.2276|0.7914
73931221|NCT04847674|147392288|OTHER||LS mean difference|-0.011||||0.9115|TWO_SIDED|95.0|-0.2126|0.19|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1900|-0.2126|0.9115
74008094|NCT02137512|147566421|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008095|NCT02137512|147566421|SUPERIORITY|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.22
74008096|NCT02137512|147566422|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
74008097|NCT02137512|147566422|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008098|NCT02137512|147566422|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008099|NCT02137512|147566423|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
73931222|NCT04847674|147392290|OTHER||LS mean difference|0.026||||0.6001|TWO_SIDED|95.0|-0.0733|0.1261|||Mixed Models Analysis||Change from baseline in FEV1 over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1261|-0.0733|0.6001
73931223|NCT04847674|147392290|OTHER||LS mean difference|0.027||||0.5922|TWO_SIDED|95.0|-0.0732|0.1276|||Mixed Models Analysis||Change from baseline in FEV1 over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1276|-0.0732|0.5922
73931224|NCT04847674|147392290|OTHER||LS mean difference|0.027||||0.6017|TWO_SIDED|95.0|-0.0744|0.1277|||Mixed Models Analysis||Change from baseline in FEV1 over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1277|-0.0744|0.6017
73931225|NCT04847674|147392290|OTHER||LS mean difference|0.022||||0.6664|TWO_SIDED|95.0|-0.0796|0.1239|||Mixed Models Analysis||Change from baseline in FEV1 over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1239|-0.0796|0.6664
73931226|NCT04847674|147392291|OTHER||Hodges-Lehmann (HL) estimator|0.4||||0.7261|TWO_SIDED|95.0|-2.33|3.31|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.31|-2.33|0.7261
73971456|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-7.764||||0.5457|TWO_SIDED|95.0|-32.993|17.465|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||17.465|-32.993|0.5457
73971457|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-175.203|||<|0.0001|TWO_SIDED|95.0|-220.445|-129.961|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-129.961|-220.445|<.0001
73931227|NCT04847674|147392291|OTHER||HL estimator|-0.5||||0.765|TWO_SIDED|95.0|-3.56|3.32|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.32|-3.56|0.7650
73971458|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-176.627|||<|0.0001|TWO_SIDED|95.0|-222.672|-130.582|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-130.582|-222.672|<.0001
74008100|NCT02137512|147566423|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
74008101|NCT02137512|147566423|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
73931228|NCT04847674|147392291|OTHER||HL estimator|0.2||||0.7942|TWO_SIDED|95.0|-2.44|3.04|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.04|-2.44|0.7942
73931229|NCT04847674|147392291|OTHER||HL estimator|-0.8||||0.6147|TWO_SIDED|95.0|-3.81|2.55|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||2.55|-3.81|0.6147
73931230|NCT04847674|147392293|OTHER||LS mean difference|-0.083||||0.4394|TWO_SIDED|95.0|-0.2971|0.1301|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1301|-0.2971|0.4394
74008102|NCT02137512|147566424|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008103|NCT02137512|147566424|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008104|NCT02137512|147566424|SUPERIORITY|||||||0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.05
74008105|NCT02137512|147566425|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
73931231|NCT04847674|147392293|OTHER||LS mean difference|-0.089||||0.4051|TWO_SIDED|95.0|-0.302|0.1231|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1231|-0.3020|0.4051
73931232|NCT04847674|147392296|OTHER||LS mean difference|0.093||||0.3485|TWO_SIDED|95.0|-0.1031|0.2893|||Mixed Models Analysis||Change from baseline in FEF25-75 over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2893|-0.1031|0.3485
73931233|NCT04847674|147392296|OTHER||LS mean difference|0.033||||0.7432|TWO_SIDED|95.0|-0.1644|0.2296|||Mixed Models Analysis||Change from baseline in FEF25-75 over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2296|-0.1644|0.7432
73931234|NCT04847674|147392296|OTHER||LS mean difference|0.087||||0.4014|TWO_SIDED|95.0|-0.118|0.292|||Mixed Models Analysis||Change from baseline in FEF25-75 over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2920|-0.1180|0.4014
73931235|NCT04847674|147392296|OTHER||LS mean difference|0.01||||0.9259|TWO_SIDED|95.0|-0.196|0.2153|||Mixed Models Analysis||Change from baseline in FEF25-75 over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2153|-0.1960|0.9259
73931236|NCT04847674|147392298|OTHER||LS mean difference|0.0||||0.9829|TWO_SIDED|95.0|-0.43|0.42|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.42|-0.43|0.9829
73931237|NCT04847674|147392298|OTHER||LS mean difference|0.1||||0.6302|TWO_SIDED|95.0|-0.32|0.52|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.52|-0.32|0.6302
73931238|NCT04847674|147392298|OTHER||LS mean difference|-0.1||||0.6707|TWO_SIDED|95.0|-0.54|0.35|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.35|-0.54|0.6707
73931239|NCT04847674|147392298|OTHER||LS mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.44|0.43|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.43|-0.44|0.9940
73931240|NCT04847674|147392299|OTHER||LS mean difference|-0.7||||0.4683|TWO_SIDED|95.0|-2.71|1.26|||Mixed Models Analysis||Change from baseline in ACT at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.26|-2.71|0.4683
73931241|NCT04847674|147392299|OTHER||LS mean difference|-1.2||||0.2239|TWO_SIDED|95.0|-3.16|0.75|||Mixed Models Analysis||Change from baseline in ACT at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||0.75|-3.16|0.2239
73931242|NCT04847674|147392299|OTHER||LS mean difference|-0.6||||0.5389|TWO_SIDED|95.0|-2.51|1.32|||Mixed Models Analysis||Change from baseline in ACT at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.32|-2.51|0.5389
73931243|NCT04847674|147392299|OTHER||LS mean difference|-0.9||||0.3564|TWO_SIDED|95.0|-2.75|1.0|||Mixed Models Analysis||Change from baseline in ACT at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.00|-2.75|0.3564
73931244|NCT04847674|147392300|OTHER||LS mean difference|-0.2||||0.4436|TWO_SIDED|95.0|-0.62|0.27|||Mixed Models Analysis||Change from baseline in AQLQT at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.27|-0.62|0.4436
73971459|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-171.515|||<|0.0001|TWO_SIDED|95.0|-216.626|-126.404|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-126.404|-216.626|<.0001
73971460|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-153.812|||<|0.0001|TWO_SIDED|95.0|-199.27|-108.354|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-108.354|-199.270|<.0001
73931245|NCT04847674|147392300|OTHER||LS mean difference|-0.1||||0.597|TWO_SIDED|95.0|-0.56|0.32|||Mixed Models Analysis||Change from baseline in AQLQT at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.32|-0.56|0.5970
73931246|NCT04847674|147392300|OTHER||LS mean difference|-0.2||||0.3769|TWO_SIDED|95.0|-0.68|0.26|||Mixed Models Analysis||Change from baseline in AQLQT at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.26|-0.68|0.3769
73931247|NCT04847674|147392300|OTHER||LS mean difference|-0.2||||0.4595|TWO_SIDED|95.0|-0.64|0.29|||Mixed Models Analysis||Change from baseline in AQLQT at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.29|-0.64|0.4595
73931248|NCT03254134|147392341|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.534|0.97||||||There was no formal hypothesis testing.|The hazard ratio of stroke for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable|0.970|0.534|
73931249|NCT03254134|147392342|SUPERIORITY||Hazard Ratio (HR)|0.549|||||TWO_SIDED|95.0|0.303|0.994||||||There was no formal hypothesis testing.|The hazard ratio of systemic embolism for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable|0.994|0.303|
73931250|NCT00378703|147392347|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm B (bevacizumab and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk)||||0.89
73931251|NCT00378703|147392347|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm C (bevacizumab and sorafenib) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).||||0.54
73931252|NCT00378703|147392347|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm D (sorafenib and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).||||0.68
73931253|NCT00378703|147392350|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.0076
74008106|NCT02137512|147566425|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
73931254|NCT00378703|147392350|SUPERIORITY_OR_OTHER|||||||0.0085|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.0085
73931255|NCT00378703|147392350|SUPERIORITY_OR_OTHER|||||||0.3006|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.3006
73931256|NCT04292730|147392362|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0174|TWO_SIDED|95.0|1.092|2.483||P-value was calculated using proportional odds model with treatment as the independent variable.|Proportional odds model|||Primary analysis||2.483|1.092|0.0174
73931257|NCT04292730|147392362|SUPERIORITY||Odds Ratio (OR)|1.31||||0.1826|TWO_SIDED|95.0|0.88|1.952||P-value was calculated using proportional odds model with treatment as the independent variable.|Proportional odds model|||Primary analysis||1.952|0.880|0.1826
73931258|NCT04292730|147392362|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0168|TWO_SIDED|95.0|1.095|2.497||P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.|Proportional odds model|||Secondary analysis||2.497|1.095|0.0168
73931259|NCT04292730|147392362|SUPERIORITY||Odds Ratio (OR)|1.29||||0.2186|TWO_SIDED|95.0|0.862|1.917||P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.|Proportional odds model|||Secondary analysis||1.917|0.862|0.2186
73931260|NCT04292730|147392363|SUPERIORITY||Difference in the Percentages|4.8||||0.3633|TWO_SIDED|95.0|-5.2|14.7||P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.|Fisher Exact|||||14.7|-5.2|0.3633
73931261|NCT04292730|147392363|SUPERIORITY||Difference in the Percentages|12.0||||0.0201|TWO_SIDED|95.0|1.6|21.8||P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.|Fisher Exact|||||21.8|1.6|0.0201
73931262|NCT00813358|147392390|NON_INFERIORITY|NI=7%|KM product-limit estimator|99.1|||||TWO_SIDED|95.0|97.4|100.0||||||||100|97.4|
73931263|NCT03851016|147392403|SUPERIORITY|||||||0.113|||||||Mancova|||"Null hypothesis is that there would be no difference in change of depressive symptoms between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the GDS-12R at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in depressive symptoms."||||.113
74008107|NCT02137512|147566425|SUPERIORITY|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.52
74008108|NCT02137512|147566426|SUPERIORITY|||||||0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.003
74008109|NCT02137512|147566426|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008110|NCT02137512|147566426|SUPERIORITY|||||||0.71||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.71
73863251|NCT01325714|147272750|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset (the primary outcome) over a 1-year period, assuming 80% power and type I error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group (anticipated based on estimated rates from prior work) versus 19% for the treatment group|Hazard Ratio (HR)|0.84||||0.84|TWO_SIDED|95.0|0.51|1.37||From discrete-time Cox regression time-to-event analyses|Regression, Cox|df = 1|The usual care arm is the reference group.|Examination of group differences in incidence of verbal aggression. We expected those in paved to have lower incidence of verbal aggression relative to those in enhanced usual care.||1.37|0.51|0.84
73863252|NCT01325714|147272751|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.86||||0.46|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 0.86||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.||||0.46
73863253|NCT01325714|147272752|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.43||||0.23|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.||||0.23
73863254|NCT01325714|147272753|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.45||||0.23|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 1.45||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported overall pain over time.||||0.23
73863255|NCT01325714|147272754|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.86||||0.62|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 409) = 0.59||Growth curve models were conducted to examine whether there were differences between treatment groups in change in patient-reported overall pain over time.||||0.62
73863256|NCT01325714|147272755|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.94||||0.42|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 453) = 0.94.||Growth curve models were conducted to examine whether there were differences between treatment groups in change in depression over time.||||0.42
73863257|NCT01325714|147272756|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.1||||0.35|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 457) = 1.10||Growth curve models were conducted to examine whether there were differences between treatment groups in change in pleasant events over time.||||0.35
73863258|NCT01325714|147272757|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.11||||0.11|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 2.00||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver burden over time.||||0.11
73863259|NCT01325714|147272758|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|3.84||||0.01|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 3.84||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported mutuality over time.||||0.01
73863260|NCT00351273|147272759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.8||||0.01|TWO_SIDED||||||Fisher Exact|||Difference in the percentages of participants with response between all those who received combination therapy vs. placebo||||0.01
73863261|NCT02530996|147272777|OTHER|Power calculations were performed using G\*Power computer software version 3. Sample-size calculations were based on the number of patients needed to detect significant differences in FMD between placebo and BH4.|Mean Difference (Net)|1.5|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Statistics were performed using SPSS software (IBM, Chicago, IL). Paired t-tests were used to identify significant changes in measured variables between placebo and BH4. Unpaired t-tests were used to identify significant changes in measured variables between ordered groups. Based on data published in PMID: 25511849 power calculations for this study of SSc patients were made.||||<0.05
73863262|NCT03907033|147272829|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Hydrocodone use||||1.000
73863263|NCT03907033|147272829|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Oxycodone use||||0.010
73863264|NCT03907033|147272830|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Ibuprofen use||||0.248
73863265|NCT03907033|147272830|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Tylenol use||||1.000
73863266|NCT03907033|147272832|SUPERIORITY|||||||0.846|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 24 hours post-surgery||||0.846
73863267|NCT03907033|147272832|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 48 hours post-surgery||||0.490
73863268|NCT03907033|147272832|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 72 hours post-surgery||||0.564
73863269|NCT03907033|147272833|SUPERIORITY|||||||0.264|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 24 hours post-surgery||||0.264
73863270|NCT03907033|147272833|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 48 hours post-surgery||||0.970
73863271|NCT03907033|147272833|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 72 hours post-surgery||||0.536
74008111|NCT02137512|147566427|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
73931264|NCT03851016|147392404|SUPERIORITY|||||||0.123|||||||Mancova|||"Null hypothesis is that there would be no difference in change of Presence of Meaning (POM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the POM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in POM."||||.123
73931265|NCT03851016|147392405|SUPERIORITY|||||||0.91|||||||Mancova|||"The null hypothesis is that there would be no difference in change of Search for Meaning (SFM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the SFM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in SFM."||||.910
73931266|NCT04099524|147392416|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|-0.18|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
73931267|NCT04099524|147392416|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||||||<0.05
73931268|NCT04099524|147392417|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|chi-square|3.14|||<|0.05|TWO_SIDED||||||Chi-squared|||reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
73931269|NCT04099524|147392418|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
73931270|NCT04099524|147392419|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|0.84|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance||||<0.05
73971461|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-165.22|||<|0.0001|TWO_SIDED|95.0|-195.898|-134.541|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-134.541|-195.898|<.0001
73971462|NCT04800211|147483689|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-22.815||||0.2188|TWO_SIDED|95.0|-59.223|13.593|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||13.593|-59.223|0.2188
74008112|NCT02137512|147566427|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
73931271|NCT04733157|147392420|OTHER||Risk Ratio (RR)|0.87|STANDARD_ERROR_OF_MEAN|0.1||0.33|TWO_SIDED|95.0|0.69|1.09||Threshold for statistical significance was 0.05|Chi-squared|||||1.09|0.69|0.33
73931272|NCT03337724|147392440|SUPERIORITY||Stratified Hazard Ratio|1.02||||0.9237|TWO_SIDED|95.0|0.71|1.45|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, tumor PIK3CA/AKT1/PTEN alteration status (PIK3CA/AKT1-activating mutations vs. PTEN alterations with no PIK3CA/AKT1-activating mutations).|||1.45|0.71|0.9237
73931273|NCT03337724|147392441|SUPERIORITY||Stratified Hazard Ratio|1.0||||0.9965|TWO_SIDED|95.0|0.71|1.4|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).|||1.40|0.71|0.9965
73931274|NCT03337724|147392449|SUPERIORITY||Stratified Hazard Ratio|1.08|||||TWO_SIDED|95.0|0.73|1.58|||||Stratification was done prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, tumor PIK3CA/AKT1/PTEN alteration status (PIK3CA/AKT1-activating mutations vs. PTEN alterations with no PIK3CA/AKT1-activating mutations).|||1.58|0.73|
73931275|NCT03337724|147392449|SUPERIORITY||Stratified Hazard Ratio|0.94|||||TWO_SIDED|95.0|0.65|1.37|||||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).|||1.37|0.65|
73931276|NCT03337724|147392452|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.2162|TWO_SIDED|95.0|0.83|2.22|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).||Stratified Analysis|2.22|0.83|0.2162
73931277|NCT03551210|147392467|NON_INFERIORITY|The non-inferiority bound was designated at the level of -15%|Difference in percentage|6.1|||||TWO_SIDED|95.0|-0.7|13.0||||||||13.0|-0.7|
73931278|NCT03551210|147392467|OTHER||Odds Ratio (OR)|1.45|||=|0.499|TWO_SIDED|95.0|0.49|4.29|||Regression, Logistic|||||4.29|0.49|=0.499
73931279|NCT03551210|147392468|OTHER||Difference in percentage|4.3|||=|0.08|TWO_SIDED|95.0|-0.6|9.7|||Barnard's test|||Visit 2||9.7|-0.6|=0.08
73931280|NCT03551210|147392468|OTHER||Difference in percentage|3.7|||=|0.246|TWO_SIDED|95.0|-2.0|9.8|||Barnard's test|||Visit 3||9.8|-2.0|=0.246
74008113|NCT02137512|147566427|SUPERIORITY|||||||0.39||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.39
74008114|NCT02137512|147566428|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
73863272|NCT03907033|147272834|SUPERIORITY|||||||0.957|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 24 hours post-surgery||||0.957
73863273|NCT03907033|147272834|SUPERIORITY|||||||0.353|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 48 hours post-surgery||||0.353
73863274|NCT03907033|147272834|SUPERIORITY|||||||0.165|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 72 hours post-surgery||||0.165
73863275|NCT03907033|147272836|SUPERIORITY|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 72 hours post-surgery||||0.802
73863276|NCT03907033|147272836|SUPERIORITY|||||||0.656|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 7-10 days post-surgery||||0.656
73931281|NCT03551210|147392469|OTHER||||||=|0.154|||||||Barnard test|||||||=0.154
73931282|NCT03551210|147392470|OTHER||||||=|0.14|||||||Log Rank|||||||=0.14
73931283|NCT03551210|147392471|OTHER||||||=|0.26|||||||Barnard test|||||||=0.26
73931284|NCT03551210|147392472|OTHER||||||=|0.14||||||Visit 2 assessment|Barnard's test|||||||=0.14
73931285|NCT03551210|147392472|OTHER|||||||0.515||||||Visit 3 assessment|Barnard's test|||||||0.515
73931286|NCT03551210|147392472|OTHER|||||||0.515||||||Visit 4 assessment|Barnard's test|||||||0.515
73931287|NCT00991302|147392481|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|stratified by dosing complexity||"Treatment comparison was made using a Wilcoxon rank sum test stratified by dosing complexity.~The test was not stratified by region of enrollment due to dosing complexity and region of enrollment were almost identical: almost all (exception with two) participants in the US region were on QD and all participants in the Peru region were on BID or TID."||||0.52
73863277|NCT01174173|147272837|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||A two-sided t-test was performed with p-value \< 0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.0013
73863278|NCT01174173|147272838|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED|||||A two-sided t-test was performed for change in 6-minute walk test and p-value \< 0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.09
73863279|NCT01174173|147272839|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||A two-sided t-test was performed for difference from baseline and 3-month KCCQ score. A p-value of \<0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.37
73863280|NCT01174173|147272841|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
73863281|NCT01174173|147272842|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
73863282|NCT02198794|147272860|OTHER||Least Square (LS) Mean Difference|-0.6||||0.121|TWO_SIDED|95.0|-1.42|0.17||Threshold for significance at 0.05 level.|ANCOVA|||The statistical model was an analysis of covariance (ANCOVA) with treatment group and dopamine receptor antagonist status at the pre-withdrawal visit as fixed effects and the pre-withdrawal visit value as a covariate.||0.17|-1.42|0.121
73863283|NCT02408523|147272873|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.001|TWO_SIDED|95.0|0.377|0.774||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants' Baseline PGTCS frequency and Development from interactive response technology (IRT) (\<= 2 per 28 days in the Combined Baseline Period and Pediatric, \<= 2 per 28 days in the Combined Baseline Period and Adult, and \> 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.||0.774|0.377|<0.001
73863284|NCT02408523|147272874|SUPERIORITY||KM seizure free of LCM vs Placebo|14.1|||=|0.011|TWO_SIDED|95.0|3.2|25.1||Superiority of LCM vs Placebo p-value was based on a chi-square test on 1 degree of freedom.|Mantel Haenszel||Stratified difference in proportion of subjects who are seizure-free from PGTCS on Lacosamide (FAS) vs Placebo (FAS).|The key secondary efficacy variable was evaluated using an extended Mantel-Haenszel testing procedure. Baseline PGTCS Frequency from Combined Baseline and development (age from interactive response technology (IRT)) were calculated from IRT.||25.1|3.2|=0.011
73863285|NCT02408523|147272875|SUPERIORITY||Hazard Ratio (HR)|0.683|||=|0.012|TWO_SIDED|95.0|0.507|0.921||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants' Baseline PGTCS frequency and Development from interactive response technology (IRT) (\<= 2 per 28 days in the Combined Baseline Period and Pediatric, \<= 2 per 28 days in the Combined Baseline Period and Adult, and \> 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.||0.921|0.507|=0.012
73931288|NCT01709318|147392489|NON_INFERIORITY|Based on a longitudinal data analysis (LDA) model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|8.3|||||TWO_SIDED|95.0|-4.3|26.5|||||95% CI adjusted for multiplicity (Dunnett)|||26.5|-4.3|
73931289|NCT01709318|147392489|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.5|||||TWO_SIDED|95.0|-5.7|24.8|||||95% CI adjusted for multiplicity (Dunnett)|||24.8|-5.7|
73931290|NCT01709318|147392489|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|12.3|||||TWO_SIDED|95.0|-1.7|33.1|||||95% CI adjusted for multiplicity (Dunnett)|||33.1|-1.7|
74008115|NCT02137512|147566428|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008116|NCT02137512|147566428|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
74008117|NCT02137512|147566429|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
74008118|NCT02137512|147566429|SUPERIORITY|||||||0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.003
74008119|NCT02137512|147566429|SUPERIORITY|||||||0.86||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.86
74088524|NCT01833533|147730431|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|90.2|||||TWO_SIDED|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||94.3|86.2|
74088525|NCT01833533|147730431|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|97.0|||||TWO_SIDED|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|93.7|
74088526|NCT01833533|147730432|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
74088527|NCT01833533|147730433|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|97.0|||||TWO_SIDED|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|93.7|
74088528|NCT01833533|147730433|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.2|||||TWO_SIDED|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||94.3|86.2|
74088529|NCT01833533|147730433|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment in the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% CI (calculated using normal approximation to the binomial distribution)for the difference in percentage of participants must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|-6.8|||||TWO_SIDED|95.0|-12.0|-1.5|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV arm compared with the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (normal approximation of a single binomial proportion in a one-sample test for superiority).||-1.5|-12.0|
74088530|NCT01138826|147730443|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|105.57|||||TWO_SIDED|90.0|98.09|113.61||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||113.61|98.09|
73863286|NCT02252965|147272895|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of this efficacy outcome measure is -0.4%.|Least Squares (LS) Mean Difference|0.03|||||TWO_SIDED|95.0|-0.1|0.17||||||||0.17|-0.10|
74091598|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|5.05|||||TWO_SIDED|95.0|2.59|9.85|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15A||9.85|2.59|
74008120|NCT02137512|147566430|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
73863287|NCT02252965|147272896|SUPERIORITY_OR_OTHER||Percentage difference|-1.52||||0.674|TWO_SIDED|95.0|-8.6|5.56|||Mantel Haenszel|||||5.56|-8.60|0.674
74008121|NCT02137512|147566430|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008122|NCT02137512|147566430|SUPERIORITY|||||||0.74||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.74
74008123|NCT02137512|147566431|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74088531|NCT01138826|147730443|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|107.55|||||TWO_SIDED|90.0|99.98|115.69||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||115.69|99.98|
73931291|NCT01709318|147392489|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.6|||||TWO_SIDED|95.0|-5.7|25.4|||||95% CI adjusted for multiplicity (Dunnett)|||25.4|-5.7|
73931292|NCT01709318|147392489|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|9.3|||||TWO_SIDED|95.0|-3.5|27.4|||||95% CI adjusted for multiplicity (Dunnett)|||27.4|-3.5|
73931293|NCT01709318|147392489|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-10.7|15.9|||||95% CI adjusted for multiplicity (Dunnett)|||15.9|-10.7|
73931294|NCT01709318|147392490|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.2|||||TWO_SIDED|95.0|-3.6|16.4|||||95% CI adjusted for multiplicity (Dunnett)|||16.4|-3.6|
73931295|NCT01709318|147392490|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)|||11.0|-6.2|
73931296|NCT01709318|147392490|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.0|||||TWO_SIDED|95.0|-3.8|17.5|||||95% CI adjusted for multiplicity (Dunnett)|||17.5|-3.8|
73971463|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-248.311|||<|0.0001|TWO_SIDED|95.0|-286.423|-210.199|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-210.199|-286.423|<.0001
73971464|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-247.572|||<|0.0001|TWO_SIDED|95.0|-280.904|-214.241|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-214.241|-280.904|<.0001
74008124|NCT02137512|147566431|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
73931297|NCT01709318|147392490|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|4.7|||||TWO_SIDED|95.0|-2.5|18.9|||||95% CI adjusted for multiplicity (Dunnett)|||18.9|-2.5|
73931298|NCT01709318|147392490|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|1.4|||||TWO_SIDED|95.0|-5.0|13.4|||||95% CI adjusted for multiplicity (Dunnett)|||13.4|-5.0|
73931299|NCT01709318|147392490|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)|||11.0|-6.2|
74008125|NCT02137512|147566431|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
74008126|NCT02137512|147566432|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
74091599|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|8.92|||||TWO_SIDED|95.0|4.55|17.5|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15A||17.50|4.55|
74091600|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.4|||||TWO_SIDED|95.0|2.38|8.15|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15C||8.15|2.38|
73971465|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-245.868|||<|0.0001|TWO_SIDED|95.0|-284.945|-206.791|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-206.791|-284.945|<.0001
73971466|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-234.942|||<|0.0001|TWO_SIDED|95.0|-271.603|-198.282|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-198.282|-271.603|<.0001
73971467|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-244.049|||<|0.0001|TWO_SIDED|95.0|-275.269|-212.829|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-212.829|-275.269|<.0001
73971468|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-221.385|||<|0.0001|TWO_SIDED|95.0|-258.371|-184.398|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-184.398|-258.371|<.0001
73971469|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-233.626|||<|0.0001|TWO_SIDED|95.0|-261.113|-206.14|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-206.140|-261.113|<.0001
74008127|NCT02137512|147566432|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
74008128|NCT02137512|147566432|SUPERIORITY|||||||0.68||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.68
74008129|NCT02137512|147566433|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
74008130|NCT02137512|147566433|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
74008131|NCT02137512|147566433|SUPERIORITY|||||||0.62||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.62
74029782|NCT03151148|147614041|SUPERIORITY||Geometric mean ratio (GMR)|1.719||||0.767|TWO_SIDED|95.0|0.0474|62.3828|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||62.3828|0.0474|0.767
74029783|NCT03151148|147614043|SUPERIORITY||Geometric mean ratio (GMR)|1.395||||0.488|TWO_SIDED|95.0|0.5429|3.5835|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.5835|0.5429|0.488
74029784|NCT03151148|147614043|SUPERIORITY||Geometric mean ratio (GMR)|2.823||||0.03|TWO_SIDED|95.0|1.1038|7.221|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.2210|1.1038|0.030
74029785|NCT03151148|147614043|SUPERIORITY||Geometric mean ratio (GMR)|2.077||||0.127|TWO_SIDED|95.0|0.8122|5.3135|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.3135|0.8122|0.127
74029786|NCT03151148|147614043|SUPERIORITY||Geometric mean ratio (GMR)|0.789||||0.623|TWO_SIDED|95.0|0.3065|2.0331|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.0331|0.3065|0.623
74029787|NCT03151148|147614043|SUPERIORITY||Geometric mean ratio (GMR)|0.627||||0.328|TWO_SIDED|95.0|0.245|1.6028|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.6028|0.2450|0.328
73931300|NCT01709318|147392491|OTHER|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.08||||0.096|||||||LDA|||||||0.096
74029788|NCT03151148|147614043|SUPERIORITY||Geometric mean ratio (GMR)|2.231||||0.242|TWO_SIDED|95.0|0.5799|8.5866|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.5866|0.5799|0.242
74029789|NCT03151148|147614043|SUPERIORITY||Geometric mean ratio (GMR)|1.977||||0.321|TWO_SIDED|95.0|0.5137|7.6055|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.6055|0.5137|0.321
74091601|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.92|||||TWO_SIDED|95.0|2.64|9.16|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15C||9.16|2.64|
73931301|NCT01709318|147392491|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.993|||||||LDA|||||||0.993
73931302|NCT01709318|147392491|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.08||||0.124|||||||LDA|||||||0.124
73931303|NCT01709318|147392491|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.05||||0.845|||||||LDA|||||||0.845
73931304|NCT01709318|147392491|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||0.976|||||||LDA|||||||0.976
73931305|NCT01709318|147392491|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.995|||||||LDA|||||||0.995
73931306|NCT01709318|147392492|OTHER|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.01||||1|||||||LDA|||||||1.000
73931307|NCT01709318|147392492|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.19||||0.996|||||||LDA|||||||0.996
73931308|NCT01709318|147392492|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.06||||1|||||||LDA|||||||1.000
73931309|NCT01709318|147392492|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||1|||||||LDA|||||||1.000
73931310|NCT01709318|147392492|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.09||||1|||||||LDA|||||||1.000
73931311|NCT01709318|147392492|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.24||||0.998|||||||LDA|||||||0.998
73971470|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|26.266||||0.1672|TWO_SIDED|95.0|-11.13|63.661|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||63.661|-11.130|0.1672
73971471|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.051||||0.014|TWO_SIDED|95.0|-71.881|-8.221|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-8.221|-71.881|0.0140
73931312|NCT01513317|147392536|SUPERIORITY_OR_OTHER||Difference in proportions|0.082||||0.271|TWO_SIDED|95.0|-0.03|0.2|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who had a reduction in RBC transfusion to treat the anemia of MDS.|||0.20|-0.03|0.271
73931313|NCT01513317|147392537|SUPERIORITY_OR_OTHER||Difference in LS means|0.07||||0.872|TWO_SIDED|95.0|-0.79|0.93|||ANCOVA||The estimated parameter is the difference in LS means of the change from baseline hemoglobin levels at Week 13.|||0.93|-0.79|0.872
73931314|NCT01513317|147392538|SUPERIORITY_OR_OTHER||Difference in proportions|0.042||||0.494|TWO_SIDED|95.0|-0.06|0.15|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants achieving hemoglobin improvement at Week 13.|||0.15|-0.06|0.494
73931315|NCT01513317|147392539|SUPERIORITY_OR_OTHER||Difference in proportions|0.002||||0.986|TWO_SIDED|95.0|-0.09|0.09|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who did not require a blood transfusion in the 8 weeks of treatment before unblinding at Week 13.|||0.09|-0.09|0.986
73931316|NCT01513317|147392540|SUPERIORITY_OR_OTHER||Difference in LS means|1.96||||0.363|TWO_SIDED|95.0|-2.35|6.27|||ANCOVA||The estimated parameter is the difference in LS means for changes from baseline in bone marrow blasts at Week 13.|||6.27|-2.35|0.363
73931317|NCT01513317|147392541|SUPERIORITY_OR_OTHER||Difference in LS means|-1.69||||0.073|TWO_SIDED|95.0|-3.55|0.17|||ANCOVA||The estimated parameter is the difference in LS means of the number of RBC transfusions during the 8 weeks of treament before unblinding at Week 13.|||0.17|-3.55|0.073
73931318|NCT01797536|147392548|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|0.61|||||TWO_SIDED|90.0|0.34|1.08|||||GMR= Mild Hepatic Insufficiency Geometric Mean (GM) divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.34|
73931319|NCT01797536|147392548|SUPERIORITY_OR_OTHER||GMR|0.72|||||TWO_SIDED|90.0|0.4|1.31|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.31|0.40|
73931320|NCT01797536|147392548|SUPERIORITY_OR_OTHER||GMR|0.88|||||TWO_SIDED|90.0|0.48|1.61|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.61|0.48|
73931321|NCT01797536|147392549|SUPERIORITY_OR_OTHER||GMR|0.6|||||TWO_SIDED|90.0|0.34|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.05|0.34|
73931322|NCT01797536|147392549|SUPERIORITY_OR_OTHER||GMR|0.64|||||TWO_SIDED|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.14|0.35|
73931323|NCT01797536|147392549|SUPERIORITY_OR_OTHER||GMR|0.63|||||TWO_SIDED|90.0|0.35|1.13|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.13|0.35|
73931324|NCT01797536|147392550|SUPERIORITY_OR_OTHER||GMR|0.58|||||TWO_SIDED|90.0|0.32|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.05|0.32|
73931325|NCT01797536|147392550|SUPERIORITY_OR_OTHER||GMR|0.64|||||TWO_SIDED|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.14|0.35|
73931326|NCT01797536|147392550|SUPERIORITY_OR_OTHER||GMR|0.58|||||TWO_SIDED|90.0|0.32|1.08|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.32|
73931327|NCT01797536|147392551|SUPERIORITY_OR_OTHER||GMR|0.61|||||TWO_SIDED|90.0|0.34|1.08|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.34|
73931328|NCT01797536|147392551|SUPERIORITY_OR_OTHER||GMR|0.69|||||TWO_SIDED|90.0|0.38|1.25|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.25|0.38|
73931329|NCT01797536|147392551|SUPERIORITY_OR_OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.43|1.43|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.43|0.43|
73931330|NCT00120042|147392554|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||We planned that up to 300 women would be recruited. This sample size would achieve 80% poer at a 5% significance level to detect a reduction from 40% placental retention rate with no specific therapy (Group 1) to 20% with Group 2 or 3. An interim analysis was planned after 240 women had been recruited.||||0.05
73931331|NCT00120042|147392555|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73931332|NCT00047463|147392568|SUPERIORITY_OR_OTHER|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the groups would be similar in tolerance. This was a pilot study so we did not do a power calculation.||||0.26
73931333|NCT04589559|147392578|OTHER|Paired-samples t-test|Mean change score|-1.5||||0.152|TWO_SIDED|95.0|-3.67|0.67|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in cardiac-related interoceptive fear.|||0.67|-3.67|0.152
73931334|NCT04589559|147392579|OTHER|Paired-samples t-test|Mean change score|-6.2||||0.031|TWO_SIDED|95.0|-11.71|-0.69|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in trait anxiety.|||-0.69|-11.71|0.031
74039386|NCT04847141|147632406|SUPERIORITY||Difference in Percentage|1.2||||0.8197|TWO_SIDED|95.0|-9.6|12.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants meeting the primary efficacy endpoint between C19-IG 20% 2 g and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||12.0|-9.6|0.8197
74091602|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|3.41|||||TWO_SIDED|95.0|1.97|5.91|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 16F||5.91|1.97|
73931335|NCT04589559|147392580|OTHER|Paired-samples t-test|Mean change score|-1.9||||0.323|TWO_SIDED|95.0|-6.01|2.21|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in negative affect.|||2.21|-6.01|0.323
73931336|NCT04589559|147392581|OTHER|Paired-samples t-test|Mean change in the measure|0.58||||0.112|TWO_SIDED|95.0|-0.16|1.33|||t-test, 2 sided|Paired-samples t-test|A positive value of the estimation parameter of mean change in the measure indicates an increase in heart rate variability.|||1.33|-0.16|0.112
73931337|NCT02214147|147392594|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|1.42|||||TWO_SIDED|90.0|1.12|1.8|||||Least Squares Geometric Means Ratio= Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||1.80|1.12|
73931338|NCT02214147|147392595|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|3.21|||||TWO_SIDED|90.0|2.33|4.43|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||4.43|2.33|
73931339|NCT02214147|147392596|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|2.54|||||TWO_SIDED|90.0|1.84|3.53|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||3.53|1.84|
73971472|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-42.635||||0.0288|TWO_SIDED|95.0|-80.785|-4.484|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-4.484|-80.785|0.0288
73971473|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-274.577|||<|0.0001|TWO_SIDED|95.0|-345.428|-203.726|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-203.726|-345.428|<.0001
73971474|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-207.521|||<|0.0001|TWO_SIDED|95.0|-269.198|-145.844|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-145.844|-269.198|<.0001
73971475|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-203.233|||<|0.0001|TWO_SIDED|95.0|-275.683|-130.784|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-130.784|-275.683|<.0001
73971476|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-261.208|||<|0.0001|TWO_SIDED|95.0|-330.647|-191.769|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-191.769|-330.647|<.0001
74008132|NCT02137512|147566434|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008133|NCT02137512|147566434|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
74008134|NCT02137512|147566434|SUPERIORITY|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.23
74008135|NCT02137512|147566435|SUPERIORITY|||||||0.67||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.67
74008136|NCT02137512|147566435|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
74008137|NCT02137512|147566435|SUPERIORITY|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.22
74008138|NCT02137512|147566436|SUPERIORITY|||||||0.25||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.25
74008139|NCT02137512|147566437|SUPERIORITY|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.23
73863288|NCT00167388|147272908|SUPERIORITY_OR_OTHER|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre- to post- feed in the anemic state for babies \<1250 gm||||0.571
73931340|NCT02664038|147392612|SUPERIORITY||Mean Difference (Final Values)|-2.82|STANDARD_ERROR_OF_MEAN|2.68|<|0.05|TWO_SIDED|0.05|-8.23|2.588|||ANCOVA|covaried for days of heavy drinking over the 30 days prior to randomization.||||2.588|-8.23|<.05
74008140|NCT02137512|147566438|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008141|NCT02137512|147566439|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008142|NCT02137512|147566440|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008143|NCT02137512|147566441|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008144|NCT02137512|147566442|SUPERIORITY|||||||0.01||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.01
74008145|NCT02137512|147566443|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
74039387|NCT04847141|147632407|SUPERIORITY||Least squares (LS) Mean Difference|0.1||||0.5756|TWO_SIDED|95.0|-0.24|0.44|||ANCOVA||95% CI for the difference in LS Mean between 1 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 7||0.44|-0.24|0.5756
73863289|NCT00167388|147272908|SUPERIORITY_OR_OTHER|||||||0.345|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies \<1250 gm while anemic||||0.345
73931341|NCT02664038|147392613|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.66|<|0.05|TWO_SIDED|0.05|-3.26|3.61|||ANCOVA|Days of heavy drinking 30 days prior to randomization||||3.61|-3.26|<.05
73931342|NCT02664038|147392614|SUPERIORITY||Mean Difference (Final Values)|2.94|STANDARD_ERROR_OF_MEAN|1.49||0.77|TWO_SIDED|0.05|1.45|4.43|||Mixed Models Analysis|Repeated measure with Baseline, 13 weeks and 26 weeks||||4.43|1.45|.77
73931343|NCT02664038|147392615|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|1.53|<|0.05|TWO_SIDED|95.0|-1.61|4.5|||Mixed Models Analysis|||||4.50|-1.61|<.05
73931344|NCT02664038|147392616|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.43||0.05|TWO_SIDED|0.05|0.19|1.11|||t-test, 2 sided|||||1.11|.19|.05
73931345|NCT05421078|147392617|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.14|-36.53|<.0001
73931346|NCT05421078|147392617|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
73931347|NCT05421078|147392617|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
73931348|NCT05421078|147392618|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||p value is calculated||-15.14|-36.53|<.0001
73931349|NCT05421078|147392618|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
73931350|NCT05421078|147392618|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
73931351|NCT05421078|147392619|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.14|-36.53|<.0001
73931352|NCT05421078|147392619|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
73931353|NCT05421078|147392619|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
73931354|NCT05421078|147392620|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
73931355|NCT05421078|147392620|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
73931356|NCT05421078|147392620|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
73931357|NCT05421078|147392621|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
73931358|NCT05421078|147392621|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
73931359|NCT05421078|147392621|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
73931360|NCT05421078|147392622|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
73931361|NCT05421078|147392622|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
73931362|NCT05421078|147392622|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
73931363|NCT05421078|147392623|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
73863290|NCT00167388|147272908|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in superior mesenteric artery blood flow velocity from pre- to post- feed in the anemic state for babies \>1250 gm||||0.006
73863291|NCT00167388|147272908|SUPERIORITY_OR_OTHER|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies \>1250 gm while anemic||||0.035
73863292|NCT00167388|147272908|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusion||||0.910
73863293|NCT00167388|147272908|SUPERIORITY_OR_OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Change in Peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusion||||0.850
73863294|NCT00167388|147272908|SUPERIORITY_OR_OTHER|||||||0.507|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusion||||0.507
73863295|NCT00167388|147272908|SUPERIORITY_OR_OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Change in peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusion||||0.286
73863296|NCT05149313|147272934|SUPERIORITY||Difference in percentages|27.88|||<|0.0001|TWO_SIDED|95.0|15.63|40.14|||Cochran-Mantel-Haenszel|||||40.14|15.63|<0.0001
74039388|NCT04847141|147632407|SUPERIORITY||LS Mean Difference|-0.17||||0.3289|TWO_SIDED|95.0|-0.52|0.17|||ANCOVA||95% CI for the difference in LS Mean between 2 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 7||0.17|-0.52|0.3289
73863297|NCT05149313|147272935|SUPERIORITY||Difference in percentages|17.8||||0.0052|TWO_SIDED|95.0|7.03|28.57|||Cochran-Mantel-Haenszel|||||28.57|7.03|0.0052
73863298|NCT05149313|147272936|SUPERIORITY||Difference in percentages|18.15||||0.0114|TWO_SIDED|95.0|5.47|30.83|||Cochran-Mantel-Haenszel|||||30.83|5.47|0.0114
73863299|NCT00300677|147272970|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||467.43|192.91|
73863300|NCT00300677|147272970|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||300.00|123.81|
73863301|NCT00300677|147272971|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of the adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||467.43|192.91|
73971477|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-203.998|||<|0.0001|TWO_SIDED|95.0|-263.396|-144.599|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-144.599|-263.396|<.0001
74008146|NCT02137512|147566444|SUPERIORITY|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.14
74008147|NCT02615470|147566452|SUPERIORITY||||||=|0.202||||||A priori alpha = 0.05|Wilcoxon (Mann-Whitney)|||||||=0.202
74008148|NCT02615470|147566453|SUPERIORITY|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
74008149|NCT02615470|147566454|SUPERIORITY||||||=|0.322||||||a priori alpha = 0.05|Wilcoxon (Mann-Whitney)|||||||=0.322
74008150|NCT01817907|147566456|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||||||0.52
74008151|NCT03627767|147566482|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.286|0.424||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.424|0.286|< 0.0001
74039389|NCT04847141|147632407|SUPERIORITY||LS Mean Difference|0.11||||0.3418|TWO_SIDED|95.0|-0.12|0.34|||ANCOVA||95% CI for the difference in LS Mean between 1 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 14||0.34|-0.12|0.3418
73863302|NCT00300677|147272971|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||300.00|123.81|
73863303|NCT00300677|147272972|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|12.39||||||90.0|7.09|21.65|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||21.65|7.09|
74039390|NCT04847141|147632407|SUPERIORITY||LS Mean Difference|-0.11||||0.3688|TWO_SIDED|95.0|-0.34|0.13|||ANCOVA||95% CI for the difference in LS Mean between 2 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 14||0.13|-0.34|0.3688
73863304|NCT00300677|147272972|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|31.57||||||90.0|18.06|55.18|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||55.18|18.06|
73863305|NCT00300677|147272973|SUPERIORITY_OR_OTHER||predose: ratio adjusted mean|12.39||||||90.0|7.09|21.65|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plama (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||21.65|7.09|
73863306|NCT00300677|147272973|SUPERIORITY_OR_OTHER||postdose: ratio adjusted mean|31.57||||||90.0|18.06|55.18|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||55.18|18.06|
73863307|NCT00443781|147272998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||McNemar|Exact test was used.||Mcnemar test was used to test the difference between paired PD (provocative discography) and F.A.D. (Functional Anesthetic Discography) proportions.||||0.002
73863308|NCT02066415|147272999|SUPERIORITY|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.04."|Difference in LS Means|-2.46|||<|0.001|TWO_SIDED|95.0|-3.52|-1.39|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.39|-3.52|<0.001
73863309|NCT02066415|147272999|SUPERIORITY|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.01."|Difference in LS Means|-2.45|||<|0.001|TWO_SIDED|95.0|-3.51|-1.38|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.38|-3.51|<0.001
73863310|NCT02066415|147273000|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.46|3.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).||3.27|1.46|<0.001
74091603|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|6.58|||||TWO_SIDED|95.0|3.78|11.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 16F||11.45|3.78|
74091604|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.42|||||TWO_SIDED|95.0|4.35|20.4|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23A||20.40|4.35|
74039391|NCT04847141|147632408|SUPERIORITY||Difference in Percentage|-1.3||||0.1506|TWO_SIDED|95.0|-4.7|1.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 3||1.2|-4.7|0.1506
73863311|NCT02066415|147273000|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.56|3.51|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).||3.51|1.56|<0.001
73863312|NCT02066415|147273001|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-1.86|||<|0.001|TWO_SIDED|95.0|-2.6|-1.13|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.13|-2.60|<0.001
73863313|NCT02066415|147273001|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-2.55|||<|0.001|TWO_SIDED|95.0|-3.28|-1.82|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.82|-3.28|<0.001
73863314|NCT02066415|147273002|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-9.54||||0.28|TWO_SIDED|95.0|-26.98|7.9|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||7.90|-26.98|0.28
73863315|NCT02066415|147273002|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-19.31||||0.03|TWO_SIDED|95.0|-36.71|-1.92|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.92|-36.71|0.030
73863316|NCT05432167|147273009|SUPERIORITY||Mean Difference (Final Values)|-8.08|STANDARD_ERROR_OF_MEAN|2.676||0.003|TWO_SIDED|95.0|-13.36|-2.79|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-2.79|-13.36|0.003
73863317|NCT05432167|147273010|SUPERIORITY||Mean Difference (Final Values)|-7.22|STANDARD_ERROR_OF_MEAN|3.051||0.019|TWO_SIDED|95.0|-13.24|-1.19|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-1.19|-13.24|0.019
73863318|NCT05432167|147273011|SUPERIORITY||Mean Difference (Final Values)|-8.99|STANDARD_ERROR_OF_MEAN|3.098||0.004|TWO_SIDED|95.0|-15.1|-2.87|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-2.87|-15.10|0.004
73863319|NCT00110461|147273016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.99|||<|0.0001|TWO_SIDED|95.0|-8.49|-3.5|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.||-3.5|-8.49|<0.0001
73863320|NCT00110461|147273016|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-10.7|-5.77|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.||-5.77|-10.7|<0.0001
73931364|NCT05421078|147392623|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
73931365|NCT05421078|147392623|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
73931366|NCT05421078|147392624|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
73931367|NCT05421078|147392624|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
73931368|NCT05421078|147392624|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
73931369|NCT05421078|147392625|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
73971478|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-178.75|||<|0.0001|TWO_SIDED|95.0|-249.092|-108.408|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-108.408|-249.092|<.0001
73971479|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-190.992|||<|0.0001|TWO_SIDED|95.0|-237.134|-144.85|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-144.850|-237.134|<.0001
73971480|NCT04800211|147483690|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-24.483||||0.359|TWO_SIDED|95.0|-77.096|28.13|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||28.130|-77.096|0.3590
73971481|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.287|||<|0.0001|TWO_SIDED|95.0|-2.582|-1.992|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-1.992|-2.582|<.0001
73971482|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.415|||<|0.0001|TWO_SIDED|95.0|-2.722|-2.107|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.107|-2.722|<.0001
73971483|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.382|||<|0.0001|TWO_SIDED|95.0|-2.673|-2.09|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-2.090|-2.673|<.0001
74008152|NCT03627767|147566482|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.176|0.27||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.270|0.176|< 0.0001
73863321|NCT00110461|147273017|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.89|||<|0.0001|TWO_SIDED|95.0|-8.7|-3.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.08|-8.7|<0.0001
74029790|NCT03151148|147614043|SUPERIORITY||Geometric mean ratio (GMR)|1.86||||0.366|TWO_SIDED|95.0|0.4833|7.1564|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.1564|0.4833|0.366
74029791|NCT03151148|147614043|SUPERIORITY||Geometric mean ratio (GMR)|3.713||||0.068|TWO_SIDED|95.0|0.908|15.1856|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.1856|0.9080|0.068
74029792|NCT03151148|147614043|SUPERIORITY||Geometric mean ratio (GMR)|2.858||||0.13|TWO_SIDED|95.0|0.7328|11.1434|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||11.1434|0.7328|0.130
74029793|NCT03151148|147614044|SUPERIORITY||Geometric mean ratio (GMR)|3.16||||0.233|TWO_SIDED|95.0|0.476|20.952|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||20.952|0.476|0.233
74029794|NCT03151148|147614044|SUPERIORITY||Geometric mean ratio (GMR)|0.08||||0.008|TWO_SIDED|95.0|0.012|0.514|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.514|0.012|0.008
74029795|NCT03151148|147614044|SUPERIORITY||Geometric mean ratio (GMR)|0.04||||0.001|TWO_SIDED|95.0|0.007|0.298|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.298|0.007|0.001
74029796|NCT03151148|147614044|SUPERIORITY||Geometric mean ratio (GMR)|0.09||||0.017|TWO_SIDED|95.0|0.013|0.651|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.651|0.013|0.017
74029797|NCT03151148|147614044|SUPERIORITY||Geometric mean ratio (GMR)|0.04||||0.001|TWO_SIDED|95.0|0.007|0.292|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.292|0.007|0.001
74039392|NCT04847141|147632408|SUPERIORITY||Difference in Percentage|1.3||||0.1655|TWO_SIDED|95.0|-1.3|4.6||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 1 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 7||4.6|-1.3|0.1655
74029798|NCT03151148|147614044|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.358|TWO_SIDED|95.0|0.366|15.967|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.967|0.366|0.358
74029799|NCT03151148|147614044|SUPERIORITY||Geometric mean ratio (GMR)|0.1||||0.019|TWO_SIDED|95.0|0.016|0.683|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.683|0.016|0.019
74029800|NCT03151148|147614044|SUPERIORITY||Geometric mean ratio (GMR)|0.11||||0.023|TWO_SIDED|95.0|0.017|0.739|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.739|0.017|0.023
74029801|NCT03151148|147614044|SUPERIORITY||Geometric mean ratio (GMR)|0.09||||0.017|TWO_SIDED|95.0|0.013|0.647|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.647|0.013|0.017
74029802|NCT03151148|147614044|SUPERIORITY||Geometric mean ratio (GMR)|0.37||||0.299|TWO_SIDED|95.0|0.056|2.436|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.436|0.056|0.299
74029803|NCT03151148|147614045|SUPERIORITY||Geometric mean ratio (GMR)|1.49||||0.538|TWO_SIDED|95.0|0.415|5.38|||Mixed Models Analysis|||"TMT vs Placebo on Lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|5.380|0.415|0.538
74029804|NCT03151148|147614045|SUPERIORITY||Geometric mean ratio (GMR)|0.88||||0.849|TWO_SIDED|95.0|0.245|3.18|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.180|0.245|0.849
74029805|NCT03151148|147614045|SUPERIORITY||Geometric mean ratio (GMR)|0.4||||0.155|TWO_SIDED|95.0|0.11|1.424|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.424|0.110|0.155
74029806|NCT03151148|147614045|SUPERIORITY||Geometric mean ratio (GMR)|0.45||||0.242|TWO_SIDED|95.0|0.117|1.722|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.722|0.117|0.242
73863322|NCT00110461|147273017|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.51|||<|0.0001|TWO_SIDED|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||15.03|7.99|<0.0001
74029807|NCT03151148|147614045|SUPERIORITY||Geometric mean ratio (GMR)|0.47||||0.258|TWO_SIDED|95.0|0.129|1.735|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.735|0.129|0.258
73863323|NCT00110461|147273018|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|9.3|||<|0.0001|TWO_SIDED|95.0|5.77|12.84|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||12.84|5.77|<0.0001
74029808|NCT03151148|147614045|SUPERIORITY||Geometric mean ratio (GMR)|1.26||||0.726|TWO_SIDED|95.0|0.349|4.52|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.520|0.349|0.726
73863324|NCT00110461|147273018|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.51|||<|0.0001|TWO_SIDED|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||15.03|7.99|<0.0001
73863325|NCT00110461|147273019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.48|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.48|-1.15|<0.0001
73863326|NCT00110461|147273019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001||95.0|-1.59|-0.93|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.93|-1.59|<0.0001
73863327|NCT00110461|147273020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28||||0.0767|TWO_SIDED|95.0|-4.81|0.25|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.25|-4.81|0.0767
73863328|NCT00110461|147273020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.3515|TWO_SIDED|95.0|-3.69|1.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.32|-3.69|0.3515
73863329|NCT00110461|147273021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||<|0.0001|TWO_SIDED|95.0|-8.02|-3.73|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.73|-8.02|<0.0001
73863330|NCT00110461|147273021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.46|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.32|-7.40|<0.0001
73863331|NCT00110461|147273022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.86|||<|0.0001|TWO_SIDED|95.0|-12.3|-5.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-5.43|-12.3|<0.0001
73931370|NCT05421078|147392625|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
73931371|NCT05421078|147392625|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
73931372|NCT05421078|147392626|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|||||-14.31|-33.56|<.0001
73931373|NCT05421078|147392626|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
74029809|NCT03151148|147614045|SUPERIORITY||Geometric mean ratio (GMR)|0.32||||0.08|TWO_SIDED|95.0|0.088|1.145|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.145|0.088|0.080
74029810|NCT03151148|147614045|SUPERIORITY||Geometric mean ratio (GMR)|0.81||||0.748|TWO_SIDED|95.0|0.225|2.917|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.917|0.225|0.748
74029811|NCT03151148|147614045|SUPERIORITY||Geometric mean ratio (GMR)|1.23||||0.76|TWO_SIDED|95.0|0.327|4.617|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.617|0.327|0.760
74029812|NCT03151148|147614045|SUPERIORITY||Geometric mean ratio (GMR)|0.79||||0.713|TWO_SIDED|95.0|0.219|2.832|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.832|0.219|0.713
74029813|NCT03151148|147614046|SUPERIORITY||Geometric mean ratio (GMR)|12.08|||<|0.001|TWO_SIDED|95.0|3.524|41.435|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||41.435|3.524|<0.001
74029814|NCT03151148|147614046|SUPERIORITY||Geometric mean ratio (GMR)|2.58||||0.131|TWO_SIDED|95.0|0.753|8.853|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.853|0.753|0.131
74029815|NCT03151148|147614046|SUPERIORITY||Geometric mean ratio (GMR)|2.2||||0.21|TWO_SIDED|95.0|0.64|7.527|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.527|0.640|0.210
74029816|NCT03151148|147614046|SUPERIORITY||Geometric mean ratio (GMR)|3.98||||0.031|TWO_SIDED|95.0|1.138|13.29|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.290|1.138|0.031
74029817|NCT03151148|147614046|SUPERIORITY||Geometric mean ratio (GMR)|1.64||||0.429|TWO_SIDED|95.0|0.479|5.63|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.630|0.479|0.429
73931374|NCT05421078|147392626|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
73863332|NCT00110461|147273022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.23|||<|0.0001|TWO_SIDED|95.0|-11.6|-4.83|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-4.83|-11.6|<0.0001
73863333|NCT00110461|147273023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.23|||<|0.0001|TWO_SIDED|95.0|5.07|13.93|||t-test, 2 sided|||||13.93|5.07|<0.0001
73863334|NCT00110461|147273023|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0|||<|0.0001|TWO_SIDED|95.0|5.87|14.14|||t-test, 2 sided|||||14.14|5.87|<0.0001
74029818|NCT03151148|147614046|SUPERIORITY||Geometric mean ratio (GMR)|9.26||||0.01|TWO_SIDED|95.0|1.712|50.043|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||50.043|1.712|0.010
74029819|NCT03151148|147614046|SUPERIORITY||Geometric mean ratio (GMR)|3.45||||0.15|TWO_SIDED|95.0|0.637|18.627|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||18.627|0.637|0.150
74029820|NCT03151148|147614046|SUPERIORITY||Geometric mean ratio (GMR)|5.47||||0.048|TWO_SIDED|95.0|1.012|29.578|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||29.578|1.012|0.048
74029821|NCT03151148|147614046|SUPERIORITY||Geometric mean ratio (GMR)|3.98||||0.13|TWO_SIDED|95.0|0.665|23.821|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||23.821|0.665|0.130
74029822|NCT03151148|147614046|SUPERIORITY||Geometric mean ratio (GMR)|13.74||||0.002|TWO_SIDED|95.0|2.542|74.304|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||74.304|2.542|0.002
74029823|NCT03151148|147614047|SUPERIORITY||Geometric mean ratio (GMR)|3.68||||0.001|TWO_SIDED|95.0|1.689|8.028|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.028|1.689|0.001
74029824|NCT03151148|147614047|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.027|TWO_SIDED|95.0|1.109|5.267|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.267|1.109|0.027
74039393|NCT04847141|147632408|SUPERIORITY||Difference in Percentage|-2.0||||0.2337|TWO_SIDED|95.0|-6.5|1.7||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 7||1.7|-6.5|0.2337
73863335|NCT00110461|147273024|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.7||||0.0003|TWO_SIDED|95.0|-1.08|-0.33|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.33|-1.08|0.0003
73863336|NCT00110461|147273024|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.66|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.66|-1.41|<0.0001
73931375|NCT05421078|147392627|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.31|-33.56|<.0001
73931376|NCT05421078|147392627|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
73863337|NCT00110461|147273025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0878|TWO_SIDED|95.0|-0.54|0.04|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.04|-0.54|0.0878
73931377|NCT05421078|147392627|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
73931378|NCT05421078|147392628|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.31|-33.56|<.0001
73931379|NCT05421078|147392628|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
73931380|NCT05421078|147392628|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
73931381|NCT05421078|147392629|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
73931382|NCT05421078|147392629|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
73931383|NCT05421078|147392629|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
74008153|NCT03627767|147566482|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.503|0.78||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.780|0.503|< 0.0001
73931384|NCT05421078|147392630|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
73931385|NCT05421078|147392630|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
73931386|NCT05421078|147392630|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
73931387|NCT05421078|147392631|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
73931388|NCT05421078|147392631|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
73931389|NCT05421078|147392631|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
73931390|NCT04452188|147392666|EQUIVALENCE|Prior studies suggest a 25-50% reduction in oxidative stress in normoxia relative to supra-physiologic oxygen. A 20% difference was considered clinically meaningful, and a sample size of 42 total participants was anticipated to achieve at least 80% power with a two-sided 5% significance level. However, an interim analysis recommended by the DSMB after enrollment of 29 patients revealed a significant difference in the primary outcome between the groups, and enrollment was thus stopped.|||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||Each participant's post-operative samples were normalized to their baseline sample and described as a fold-of-change from baseline.||||<0.01
73931391|NCT04452188|147392668|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the post-operative length of stay between the two groups.||||0.66
74008154|NCT03627767|147566483|SUPERIORITY||Difference in percentage|0.0|||=|0.9495|TWO_SIDED|95.0|-1.0|1.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.1|-1.0|= 0.9495
73863338|NCT00110461|147273025|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.26||||0.0752|TWO_SIDED|95.0|-0.55|0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.03|-0.55|0.0752
74029825|NCT03151148|147614047|SUPERIORITY||Geometric mean ratio (GMR)|1.76||||0.153|TWO_SIDED|95.0|0.81|3.847|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.847|0.810|0.153
74029826|NCT03151148|147614047|SUPERIORITY||Geometric mean ratio (GMR)|1.76||||0.16|TWO_SIDED|95.0|0.799|3.884|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.884|0.799|0.160
74029827|NCT03151148|147614047|SUPERIORITY||Geometric mean ratio (GMR)|1.32||||0.489|TWO_SIDED|95.0|0.603|2.868|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.868|0.603|0.489
74029828|NCT03151148|147614047|SUPERIORITY||Geometric mean ratio (GMR)|3.1||||0.044|TWO_SIDED|95.0|1.032|9.295|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.295|1.032|0.044
74029829|NCT03151148|147614047|SUPERIORITY||Geometric mean ratio (GMR)|0.87||||0.805|TWO_SIDED|95.0|0.29|2.614|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.614|0.290|0.805
73863339|NCT00110461|147273026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.2553|TWO_SIDED|95.0|-0.51|0.13|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.13|-0.51|0.2553
73931392|NCT04452188|147392669|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the days alive and out of ICU at 30 days since surgery between the two groups||||0.66
73931393|NCT04452188|147392670|OTHER|||||||1|||||||Fisher Exact|||||||1.00
73931394|NCT04452188|147392671|OTHER|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
74029830|NCT03151148|147614047|SUPERIORITY||Geometric mean ratio (GMR)|3.62||||0.022|TWO_SIDED|95.0|1.205|10.859|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||10.859|1.205|0.022
73931395|NCT04452188|147392672|OTHER||||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.01
73931396|NCT04452188|147392673|OTHER||||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.01
73931397|NCT04452188|147392674|OTHER||||||<|0.1||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.1
73957776|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.563|STANDARD_ERROR_OF_MEAN|0.395||0.1539|TWO_SIDED|95.0|-1.338|0.211|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.211|-1.338|0.1539
74029831|NCT03151148|147614047|SUPERIORITY||Geometric mean ratio (GMR)|4.83||||0.01|TWO_SIDED|95.0|1.458|15.978|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.978|1.458|0.010
74029832|NCT03151148|147614047|SUPERIORITY||Geometric mean ratio (GMR)|2.19||||0.169|TWO_SIDED|95.0|0.716|6.692|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.692|0.716|0.169
74029833|NCT03151148|147614048|SUPERIORITY||Geometric mean ratio (GMR)|0.176||||0.035|TWO_SIDED|95.0|0.0351|0.8807|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.8807|0.0351|0.035
74029834|NCT03151148|147614048|SUPERIORITY||Geometric mean ratio (GMR)|0.214||||0.06|TWO_SIDED|95.0|0.0427|1.0702|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.0702|0.0427|0.060
74029835|NCT03151148|147614048|SUPERIORITY||Geometric mean ratio (GMR)|0.182||||0.038|TWO_SIDED|95.0|0.0363|0.91|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.9100|0.0363|0.038
74029836|NCT03151148|147614048|SUPERIORITY||Geometric mean ratio (GMR)|0.329||||0.179|TWO_SIDED|95.0|0.065|1.6691|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.6691|0.0650|0.179
74029837|NCT03151148|147614048|SUPERIORITY||Geometric mean ratio (GMR)|0.136||||0.015|TWO_SIDED|95.0|0.0271|0.6805|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.6805|0.0271|0.015
74029838|NCT03151148|147614048|SUPERIORITY||Geometric mean ratio (GMR)|0.302||||0.309|TWO_SIDED|95.0|0.0299|3.0493|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.0493|0.0299|0.309
74039394|NCT04847141|147632408|SUPERIORITY||Difference in Percentage|-0.8||||0.7212|TWO_SIDED|95.0|-6.1|4.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 1 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 14||4.2|-6.1|0.7212
74029839|NCT03151148|147614048|SUPERIORITY||Geometric mean ratio (GMR)|0.372||||0.401|TWO_SIDED|95.0|0.0369|3.7569|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.7569|0.0369|0.401
74029840|NCT03151148|147614048|SUPERIORITY||Geometric mean ratio (GMR)|0.591||||0.655|TWO_SIDED|95.0|0.0586|5.9658|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.9658|0.0586|0.655
73863340|NCT00110461|147273026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0166|TWO_SIDED|95.0|-0.71|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.07|-0.71|0.0166
73931398|NCT02047110|147392678|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5||||0.2652|TWO_SIDED|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||26.6|-12.1|0.2652
73931399|NCT02047110|147392678|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.0||||0.4129|TWO_SIDED|90.0|-15.9|20.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||20.8|-15.9|0.4129
73931400|NCT02047110|147392678|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.5||||0.4243|TWO_SIDED|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||17.0|-21.8|0.4243
73931401|NCT02047110|147392679|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.4||||0.0229|TWO_SIDED|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."|||-0.1|-0.7|0.0229
73931402|NCT02047110|147392679|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.3||||0.1038|TWO_SIDED|90.0|-0.6|0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."|||0.1|-0.6|0.1038
73931403|NCT02047110|147392679|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.5||||0.0101|TWO_SIDED|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."|||-0.1|-0.7|0.0101
73931404|NCT02047110|147392680|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.0||||0.0238|TWO_SIDED|90.0|-4.6|33.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||33.8|-4.6|0.0238
73931405|NCT02047110|147392680|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.1||||0.012|TWO_SIDED|90.0|-0.8|35.3||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||35.3|-0.8|0.0120
74029841|NCT03151148|147614048|SUPERIORITY||Geometric mean ratio (GMR)|0.43||||0.488|TWO_SIDED|95.0|0.0395|4.6836|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.6836|0.0395|0.488
74029842|NCT03151148|147614048|SUPERIORITY||Geometric mean ratio (GMR)|1.485||||0.737|TWO_SIDED|95.0|0.1471|14.9869|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||14.9869|0.1471|0.737
74029843|NCT03151148|147614049|SUPERIORITY||Geometric mean ratio (GMR)|0.248||||0.011|TWO_SIDED|95.0|0.0844|0.7281|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.7281|0.0844|0.011
74029844|NCT03151148|147614049|SUPERIORITY||Geometric mean ratio (GMR)|0.656||||0.44|TWO_SIDED|95.0|0.2245|1.9178|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.9178|0.2245|0.440
74029845|NCT03151148|147614049|SUPERIORITY||Geometric mean ratio (GMR)|0.479||||0.178|TWO_SIDED|95.0|0.164|1.4007|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.4007|0.1640|0.178
74029846|NCT03151148|147614049|SUPERIORITY||Geometric mean ratio (GMR)|0.478||||0.18|TWO_SIDED|95.0|0.1624|1.4091|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.4091|0.1624|0.180
74029847|NCT03151148|147614049|SUPERIORITY||Geometric mean ratio (GMR)|0.357||||0.06|TWO_SIDED|95.0|0.1222|1.0441|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.0441|0.1222|0.060
74029848|NCT03151148|147614049|SUPERIORITY||Geometric mean ratio (GMR)|0.498||||0.373|TWO_SIDED|95.0|0.1068|2.3188|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.3188|0.1068|0.373
74039395|NCT04847141|147632408|SUPERIORITY||Difference in Percentage|-2.1||||0.3897|TWO_SIDED|95.0|-7.8|3.1||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 14||3.1|-7.8|0.3897
74091605|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.46|||||TWO_SIDED|95.0|4.34|20.62|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23A||20.62|4.34|
74029849|NCT03151148|147614049|SUPERIORITY||Geometric mean ratio (GMR)|0.281||||0.106|TWO_SIDED|95.0|0.0604|1.3106|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.3106|0.0604|0.106
74029850|NCT03151148|147614049|SUPERIORITY||Geometric mean ratio (GMR)|1.168||||0.843|TWO_SIDED|95.0|0.2507|5.4434|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.4434|0.2507|0.843
74029851|NCT03151148|147614049|SUPERIORITY||Geometric mean ratio (GMR)|1.559||||0.587|TWO_SIDED|95.0|0.3122|7.7818|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.7818|0.3122|0.587
74029852|NCT03151148|147614049|SUPERIORITY||Geometric mean ratio (GMR)|0.707||||0.661|TWO_SIDED|95.0|0.1495|3.3426|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.3426|0.1495|0.661
74029853|NCT03151148|147614050|SUPERIORITY||Geometric mean ratio (GMR)|1197.16|||<|0.001|TWO_SIDED|95.0|525.563|2726.953|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2726.953|525.563|<0.001
74029854|NCT03151148|147614050|SUPERIORITY||Geometric mean ratio (GMR)|779.24|||<|0.001|TWO_SIDED|95.0|342.093|1774.996|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1774.996|342.093|<0.001
74029855|NCT03151148|147614050|SUPERIORITY||Geometric mean ratio (GMR)|673.56|||<|0.001|TWO_SIDED|95.0|295.697|1534.265|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1534.265|295.697|<0.001
74029856|NCT03151148|147614050|SUPERIORITY||Geometric mean ratio (GMR)|60.12|||<|0.001|TWO_SIDED|95.0|24.92|145.027|||Mixed Models Analysis|||"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|145.027|24.920|<0.001
74088532|NCT01138826|147730443|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|101.88|||||TWO_SIDED|90.0|94.7|109.6||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||109.60|94.70|
73931406|NCT02047110|147392680|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5||||0.0465|TWO_SIDED|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||31.4|-7.1|0.0465
73931407|NCT02047110|147392681|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|90.0|-19.4|19.4|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||19.4|-19.4|
73931408|NCT02047110|147392681|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|90.0|-18.3|18.3|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||18.3|-18.3|
73931409|NCT02047110|147392681|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5|||||TWO_SIDED|90.0|-12.1|26.6|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||26.6|-12.1|
73931410|NCT02047110|147392682|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.0||||0.0092|TWO_SIDED|90.0|5.5|43.1||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||43.1|5.5|0.0092
73931411|NCT02047110|147392682|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.3||||0.1243|TWO_SIDED|90.0|-5.9|30.5||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||30.5|-5.9|0.1243
73931412|NCT02047110|147392682|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5||||0.1198|TWO_SIDED|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||31.4|-7.1|0.1198
73931413|NCT02047110|147392683|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.4||||0.1241|TWO_SIDED|90.0|-1.0|0.2||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."|||0.2|-1.0|0.1241
73931414|NCT02047110|147392683|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|0.3||||0.3033|TWO_SIDED|90.0|-0.5|1.0||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."|||1.0|-0.5|0.3033
73931415|NCT02047110|147392683|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.2||||0.3203|TWO_SIDED|90.0|-0.8|0.4||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."|||0.4|-0.8|0.3203
73971484|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.486|||<|0.0001|TWO_SIDED|95.0|-2.782|-2.19|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.190|-2.782|<.0001
73971485|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.45|||<|0.0001|TWO_SIDED|95.0|-2.668|-2.233|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.233|-2.668|<.0001
74029857|NCT03151148|147614050|SUPERIORITY||Geometric mean ratio (GMR)|3.79||||0.002|TWO_SIDED|95.0|1.636|8.767|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.767|1.636|0.002
73931416|NCT02047110|147392684|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5||||0.2639|TWO_SIDED|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||26.6|-12.1|0.2639
73931417|NCT02047110|147392684|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.1||||0.2691|TWO_SIDED|90.0|-10.9|25.7||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||25.7|-10.9|0.2691
73931418|NCT02047110|147392684|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.5||||0.4174|TWO_SIDED|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||17.0|-21.8|0.4174
73931419|NCT00673452|147392688|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Model: PGI-S = baseline PGI-S + treatment + pooled investigator + visit + treatment-by-visit + baseline-by-visit.||Patients treated with 60-120 mg duloxetine for 12 weeks compared with placebo will show greater improvement in symptoms as assessed by Patient's Global Impressions of Improvement (PGI-I). Sample size determined using 2-sided t-test with significance level of 0.05, and discontinuation rate of 5% without postbaseline data. With 261 patients per arm, study has approximately 85% power to detect treatment group difference of -0.4 points (standard deviation of 1.5) in PGI-I between treatment groups.||||<0.001
73931420|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.19|-0.31||P-value for Worst Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.31|-1.19|<0.001
73931421|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.61||||0.001|TWO_SIDED|95.0|-0.99|-0.24||P-value for Least Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.24|-0.99|0.001
73931422|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.74|||<|0.001|TWO_SIDED|95.0|-1.13|-0.35||P-value for Average Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.35|-1.13|<0.001
73931423|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.2|-0.31||P-value for Pain Right Now Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.31|-1.20|<0.001
73931424|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.39|-0.49||P-value for General Activity Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.49|-1.39|<0.001
73931425|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.41|-0.49||P-value for Mood Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.49|-1.41|<0.001
73971486|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.466||||0.0012|TWO_SIDED|95.0|0.185|0.747|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.747|0.185|0.0012
74088533|NCT01138826|147730444|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|103.88|||||TWO_SIDED|90.0|97.27|110.94||||||||110.94|97.27|
73931426|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.24|-0.36||P-value for Walking Ability Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.36|-1.24|<0.001
73931427|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value for Normal Work Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.21|<0.001
73863341|NCT00110461|147273027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.51|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.51|-1.16|<0.0001
73863342|NCT00110461|147273027|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.51|-0.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.86|-1.51|<0.0001
73863343|NCT00110461|147273028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.4|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.40|-1.13|<0.0001
73863344|NCT00110461|147273028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.6|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.60|-1.33|<0.0001
73863345|NCT00110461|147273029|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.92||||0.1729|TWO_SIDED|95.0|-4.69|0.85|||t-test, 2 sided|||||0.85|-4.69|0.1729
73863346|NCT00110461|147273029|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.43||||0.75586|TWO_SIDED|95.0|-3.17|2.31|||t-test, 2 sided|||||2.31|-3.17|0.75586
73863347|NCT00110461|147273030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||<|0.0001|TWO_SIDED|95.0|-6.9|-2.61|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.61|-6.90|<0.0001
73863348|NCT00110461|147273030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.64|||<|0.0001|TWO_SIDED|95.0|-6.78|-2.5|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.50|-6.78|<0.0001
73863349|NCT00110461|147273031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.0468|TWO_SIDED|95.0|-3.67|-0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.03|-3.67|0.0468
73863350|NCT00110461|147273031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03||||0.0296|TWO_SIDED|95.0|-3.85|-0.2|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.20|-3.85|0.0296
73863351|NCT00110461|147273032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.1309|TWO_SIDED|95.0|-3.31|0.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.43|-3.31|0.1309
73863352|NCT00110461|147273032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64||||0.0058|TWO_SIDED|95.0|-4.51|-0.77|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.77|-4.51|0.0058
73863353|NCT00110461|147273033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.043|TWO_SIDED|95.0|-4.2|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.07|-4.20|0.0430
73863354|NCT00110461|147273033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.7696|TWO_SIDED|95.0|-2.37|1.76|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.76|-2.37|0.7696
73863355|NCT00110461|147273034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.9418|TWO_SIDED|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.86|-1.73|0.9418
73971487|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.099||||0.4957|TWO_SIDED|95.0|-0.187|0.386|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||0.386|-0.187|0.4957
74091606|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|3.43|||||TWO_SIDED|95.0|1.95|6.05|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23B||6.05|1.95|
73971488|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.753|||<|0.0001|TWO_SIDED|95.0|-3.266|-2.239|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-2.239|-3.266|<.0001
73971489|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.514|||<|0.0001|TWO_SIDED|95.0|-3.043|-1.986|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-1.986|-3.043|<.0001
73971490|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.848|||<|0.0001|TWO_SIDED|95.0|-3.359|-2.336|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-2.336|-3.359|<.0001
73971491|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.586|||<|0.0001|TWO_SIDED|95.0|-3.105|-2.066|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.066|-3.105|<.0001
73971492|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.55|||<|0.0001|TWO_SIDED|95.0|-2.901|-2.199|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.199|-2.901|<.0001
73971493|NCT04800211|147483691|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.071||||0.7372|TWO_SIDED|95.0|-0.346|0.489|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||0.489|-0.346|0.7372
73971494|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.106|||<|0.0001|TWO_SIDED|95.0|-3.502|-2.71|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.710|-3.502|<.0001
74091607|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.77|||||TWO_SIDED|95.0|2.69|8.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23B||8.45|2.69|
73971495|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.824|||<|0.0001|TWO_SIDED|95.0|-3.235|-2.414|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.414|-3.235|<.0001
73971496|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.228|||<|0.0001|TWO_SIDED|95.0|-3.553|-2.904|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.904|-3.553|<.0001
73971497|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.839|||<|0.0001|TWO_SIDED|95.0|-3.221|-2.457|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.457|-3.221|<.0001
73971498|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.449|||<|0.0001|TWO_SIDED|95.0|-2.828|-2.07|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.070|-2.828|<.0001
73971499|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.023|||<|0.0001|TWO_SIDED|95.0|-3.328|-2.718|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.718|-3.328|<.0001
73971500|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.126|||<|0.0001|TWO_SIDED|95.0|-3.354|-2.897|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.897|-3.354|<.0001
74091608|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|8.06|||||TWO_SIDED|95.0|3.36|19.35|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 24F||19.35|3.36|
74088534|NCT01138826|147730444|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|104.26|||||TWO_SIDED|90.0|97.67|111.3||||||||111.30|97.67|
73971501|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|0.908|||<|0.0001|TWO_SIDED|95.0|0.518|1.298|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||1.298|0.518|<.0001
73971502|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|1.291|||<|0.0001|TWO_SIDED|95.0|0.902|1.679|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||1.679|0.902|<.0001
73971503|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|0.174||||0.2772|TWO_SIDED|95.0|-0.142|0.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||0.490|-0.142|0.2772
73971504|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-4.014|||<|0.0001|TWO_SIDED|95.0|-4.75|-3.278|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.278|-4.750|<.0001
73971505|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-4.115|||<|0.0001|TWO_SIDED|95.0|-4.865|-3.365|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.365|-4.865|<.0001
74088535|NCT01138826|147730444|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|100.37|||||TWO_SIDED|90.0|94.02|107.15||||||||107.15|94.02|
73931428|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.38|-0.52||P-value for Relations with Other People Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.52|-1.38|<0.001
73931429|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.35|-0.39||P-value for Sleep Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.39|-1.35|<0.001
73931430|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.39|||<|0.001|TWO_SIDED|95.0|-1.92|-0.86||P-value for Enjoyment of Life Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.86|-1.92|<0.001
73931431|NCT00673452|147392689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.93|||<|0.001|TWO_SIDED|95.0|-1.33|-0.52||P-value for Average Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.52|-1.33|<0.001
73931432|NCT00673452|147392690|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83||||0.005|TWO_SIDED|95.0|-1.41|-0.25||P-value for General Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.25|-1.41|0.005
73931433|NCT00673452|147392690|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72||||0.013|TWO_SIDED|95.0|-1.3|-0.15||P-value for Physical Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.15|-1.30|0.013
73971506|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.403|||<|0.0001|TWO_SIDED|95.0|-4.005|-2.801|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.801|-4.005|<.0001
73971507|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.747|||<|0.0001|TWO_SIDED|95.0|-4.473|-3.02|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.020|-4.473|<.0001
74039396|NCT04847141|147632409|SUPERIORITY||Difference in Percentage|3.1||||0.5489|TWO_SIDED|95.0|-7.1|13.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 3||13.3|-7.1|0.5489
73931434|NCT00673452|147392690|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.92||||0.003|TWO_SIDED|95.0|-1.52|-0.32||P-value for Mental Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.52|0.003
73931435|NCT00673452|147392690|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88||||0.005|TWO_SIDED|95.0|-1.49|-0.26||P-value for Reduced Activity. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.26|-1.49|0.005
73931436|NCT00673452|147392690|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.49|-0.38||P-value for Reduced Motivation. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.38|-1.49|<0.001
73931437|NCT00673452|147392691|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.89||||0.007|TWO_SIDED|95.0|-3.25|-0.53||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BDI-II Total score change from baseline to endpoint = baseline BDI-II total score + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.53|-3.25|0.007
74088536|NCT01138826|147730445|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|98.39|||||TWO_SIDED|90.0|91.05|106.33||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||106.33|91.05|
73863356|NCT00110461|147273034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.19|TWO_SIDED|95.0|-1.67|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.98|-1.67|0.19
73971508|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.74|||<|0.0001|TWO_SIDED|95.0|-4.461|-3.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.018|-4.461|<.0001
73971509|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.197|||<|0.0001|TWO_SIDED|95.0|-3.784|-2.61|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.610|-3.784|<.0001
73971510|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.678|-2.921|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.921|-3.678|<.0001
73971511|NCT04800211|147483692|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-0.206||||0.348|TWO_SIDED|95.0|-0.638|0.226|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||0.226|-0.638|0.3480
73971512|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.716|||<|0.0001|TWO_SIDED|95.0|-0.951|-0.481|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)||-0.481|-0.951|<0.0001
74008155|NCT03627767|147566483|SUPERIORITY||Difference in percentage|-0.4|||=|0.5717|TWO_SIDED|95.0|-1.6|0.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.9|-1.6|= 0.5717
73931438|NCT00673452|147392692|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.51|-0.16||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: CGI-S score change from baseline at endpoint = CGI-S score baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.16|-0.51|<0.001
73931439|NCT00673452|147392693|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.07||||0.907|TWO_SIDED|95.0|-1.13|1.27||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BAI total score change from baseline to endpoint = baseline BAI total + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||1.27|-1.13|0.907
73931440|NCT00673452|147392694|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.22||||0.003|TWO_SIDED|95.0|1.76|8.67||P-value for Bodily Pain. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.67|1.76|0.003
73931441|NCT00673452|147392694|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.42|||<|0.001|TWO_SIDED|95.0|3.41|9.43||P-value for General Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||9.43|3.41|<0.001
73931442|NCT00673452|147392694|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|7.44|||<|0.001|TWO_SIDED|95.0|4.41|10.47||P-value for Mental Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||10.47|4.41|<0.001
73931443|NCT00673452|147392694|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.47||||0.002|TWO_SIDED|95.0|2.06|8.88||P-value for Physical Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.88|2.06|0.002
73931444|NCT00673452|147392694|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|9.78||||0.004|TWO_SIDED|95.0|3.11|16.45||P-value for Role-Emotional. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||16.45|3.11|0.004
73931445|NCT00673452|147392694|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.59||||0.632|TWO_SIDED|95.0|-4.93|8.11||P-value for Role-Physical. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.11|-4.93|0.632
73931446|NCT00673452|147392694|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.67|||<|0.001|TWO_SIDED|95.0|2.73|10.61||P-value for Social Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||10.61|2.73|<0.001
74091609|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|16.14|||||TWO_SIDED|95.0|6.68|39.01|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 24F||39.01|6.68|
73931447|NCT00673452|147392694|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.31||||0.015|TWO_SIDED|95.0|0.84|7.79||P-value for Vitality. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||7.79|0.84|0.015
73931448|NCT00673452|147392694|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.14||||0.134|TWO_SIDED|95.0|-0.35|2.64||P-value for Physical Component Summary (PCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||2.64|-0.35|0.134
73931449|NCT00673452|147392694|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.83|||<|0.001|TWO_SIDED|95.0|2.05|5.6||P-value for Mental Component Summary (MCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||5.60|2.05|<0.001
73931450|NCT00673452|147392695|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96||||0.083|TWO_SIDED|95.0|-2.05|0.13||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: MGH-CPFQ change from baseline at endpoint = MGH-CPFQ baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||0.13|-2.05|0.083
73931451|NCT00673452|147392696|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.18|-0.32||P-value for Mood. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.18|<0.001
73931452|NCT00673452|147392696|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64||||0.003|TWO_SIDED|95.0|-1.05|-0.22||P-value for Anxiety. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.22|-1.05|0.003
73931453|NCT00673452|147392696|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72||||0.003|TWO_SIDED|95.0|-1.19|-0.25||P-value for Pain. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.25|-1.19|0.003
74091610|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.14|||||TWO_SIDED|95.0|4.93|16.95|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 31||16.95|4.93|
73863357|NCT00110461|147273035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.9418|TWO_SIDED|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.86|-1.73|0.9418
73863358|NCT00110461|147273035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.8377|TWO_SIDED|95.0|-1.61|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.98|-1.61|0.8377
73971513|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.686|||<|0.0001|TWO_SIDED|95.0|-0.966|-0.406|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)||-0.406|-0.966|<0.0001
73971514|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.521|||<|0.0001|TWO_SIDED|95.0|-0.755|-0.288|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)||-0.288|-0.755|<.0001
73971515|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.342||||0.0131|TWO_SIDED|95.0|-0.612|-0.072|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)||-0.072|-0.612|0.0131
73971516|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.514|||<|0.0001|TWO_SIDED|95.0|-0.712|-0.316|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)||-0.316|-0.712|<.0001
73971517|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.231||||0.0435|TWO_SIDED|95.0|-0.455|-0.007|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)||-0.007|-0.455|0.0435
73971518|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|0.111||||0.4012|TWO_SIDED|95.0|-0.149|0.371|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)||0.371|-0.149|0.4012
73971519|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)|Mean Difference (Net)|-0.485||||0.0133|TWO_SIDED|95.0|-0.895|-0.074|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)||-0.074|-0.895|0.0133
74008156|NCT03627767|147566483|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-1.7|0.9||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.9|-1.7|
74008157|NCT03627767|147566483|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|33.1|47.8||P-value was adjusted by disease severity at baseline and randomization strata|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||47.8|33.1|< 0.0001
73863359|NCT00110461|147273036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.3969|TWO_SIDED|95.0|-2.71|1.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.08|-2.71|0.3969
74029858|NCT03151148|147614050|SUPERIORITY||Geometric mean ratio (GMR)|757.38|||<|0.001|TWO_SIDED|95.0|331.143|1732.242|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1732.242|331.143|<0.001
74091611|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|13.58|||||TWO_SIDED|95.0|7.28|25.32|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 31||25.32|7.28|
73971520|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.797||||0.0002|TWO_SIDED|95.0|-1.277|-0.317|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)||-0.317|-1.277|0.0002
73971521|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)|Mean Difference (Net)|-0.29||||0.2641|TWO_SIDED|95.0|-0.699|0.119|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)||0.119|-0.699|0.2641
73971522|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.453||||0.0639|TWO_SIDED|95.0|-0.924|0.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)||0.018|-0.924|0.0639
73971523|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.625||||0.0001|TWO_SIDED|95.0|-0.945|-0.305|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)||-0.305|-0.945|0.0001
73971524|NCT04800211|147483693|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)|Mean Difference (Net)|-0.344||||0.0776|TWO_SIDED|95.0|-0.725|0.038|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)||0.038|-0.725|0.0776
73971525|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.621||||0.0055|TWO_SIDED|95.0|-1.055|-0.186|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.186|-1.055|0.0055
74008158|NCT03627767|147566483|SUPERIORITY||Difference in percentage|62.6|||<|0.0001|TWO_SIDED|95.0|56.1|69.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.2|56.1|< 0.0001
74008159|NCT03627767|147566483|SUPERIORITY||Difference in percentage|22.1|||||TWO_SIDED|95.0|14.3|29.9||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.9|14.3|
73931454|NCT00673452|147392696|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49||||0.05|TWO_SIDED|95.0|-0.97|0.0||P-value for Sleep. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.00|-0.97|0.050
73931455|NCT00673452|147392696|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.32|-0.43||P-value for Stiffness. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.43|-1.32|<0.001
73931456|NCT00673452|147392697|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||0.002
73931457|NCT00673452|147392698|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||0.003
73931458|NCT00673452|147392699|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.82||||0.084|TWO_SIDED|95.0|-0.25|3.88||P-value for Systolic Blood Pressure (SBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||3.88|-0.25|0.084
73931459|NCT00673452|147392699|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52||||0.434|TWO_SIDED|95.0|-0.79|1.84||P-value for Diastolic Blood Pressure (DBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||1.84|-0.79|0.434
73931460|NCT00673452|147392700|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.96||||0.003|TWO_SIDED|95.0|0.67|3.26||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||3.26|0.67|0.003
73931461|NCT00673452|147392701|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Suicidal Ideation. A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||1.00
74029859|NCT03151148|147614050|SUPERIORITY||Geometric mean ratio (GMR)|199.71|||<|0.001|TWO_SIDED|95.0|87.636|455.127|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||455.127|87.636|<0.001
74091612|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.24|||||TWO_SIDED|95.0|5.56|15.36|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 35B||15.36|5.56|
74091613|NCT04168190|147737017|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|12.5|||||TWO_SIDED|95.0|7.49|20.87|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 35B||20.87|7.49|
73931462|NCT00673452|147392702|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.21|-0.45||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.45|-1.21|<0.001
73931463|NCT00079274|147392711|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.15|TWO_SIDED|95.0|0.92|1.68|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.||||1.68|0.92|0.15
73931464|NCT00079274|147392712|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.25|TWO_SIDED|95.0|0.85|1.92|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.||||1.92|0.85|0.25
73931465|NCT00079274|147392713|SUPERIORITY||||||<|0.001|||||||Chi-squared|two-sided chi-squared test||||||<0.001
73931466|NCT00079274|147392714|SUPERIORITY||||||<|0.001|||||||Chi-squared|Two-sided chi-squared test||||||<0.001
73931467|NCT03773757|147392721|SUPERIORITY|Longitudinal measures of NPI-Q patient over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.8719|||||||Mixed Models Analysis|||||||0.8719
73931468|NCT03773757|147392722|SUPERIORITY|Longitudinal measures of SM-EOLD over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.8389|||||||Mixed Models Analysis|||||||0.8389
73931469|NCT03773757|147392723|SUPERIORITY|Longitudinal measures of PHQ-8 over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.3431|||||||Mixed Models Analysis|||||||0.3431
73931470|NCT03773757|147392724|SUPERIORITY|Longitudinal measures of NPI-Q caregiver distress over 24 months were compared between the two groups using mixed effects model including a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.6612|||||||Mixed Models Analysis|||||||0.6612
74091614|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.67|1.47|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 3||1.47|0.67|
73863360|NCT00110461|147273036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.2101|TWO_SIDED|95.0|-3.09|0.68|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.68|-3.09|0.2101
73863361|NCT00110461|147273037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||<|0.0001|TWO_SIDED|95.0|-10.5|-3.64|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.64|-10.5|<0.0001
73931471|NCT03773757|147392725|SUPERIORITY|A zero-inflated Poisson (ZIP) model was used to compare the mean numbers of hospitalization/ED events between the two groups. The ZIP model consists of a combination of a standard Poisson distribution for count data and a binary logistic regression model to account for additional zero events exceeding what would be expected from an underlying Poisson distribution.||||||0.0007|||||||Zero-Inflated Poisson Regression Model|||||||0.0007
73971526|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.778||||0.0011|TWO_SIDED|95.0|-1.24|-0.316|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.316|-1.240|0.0011
73931472|NCT04542070|147392726|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Difference in percentage|0.9|||||TWO_SIDED|95.0|-0.5|2.2|||||Difference in percentage = percentage of Q2M - percentage of BIK|||2.2|-0.5|
73931473|NCT04542070|147392726|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Adjusted difference in percentage|0.9|||||TWO_SIDED|95.0|-0.5|2.2|||||Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.|||2.2|-0.5|
73931474|NCT04542070|147392727|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Difference in percentage|0.7|||||TWO_SIDED|95.0|-0.6|2.0|||||Difference in percentage = percentage of Q2M - percentage of BIK|||2.0|-0.6|
73931475|NCT04542070|147392727|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Adjusted difference in percentage|0.7|||||TWO_SIDED|95.0|-0.7|2.0|||||Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.|||2.0|-0.7|
73971527|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.26|-0.54|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.540|-1.260|<.0001
73863362|NCT00110461|147273037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55||||0.0014|TWO_SIDED|95.0|-8.94|-2.16|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.16|-8.94|0.0014
73931476|NCT04646616|147392759|NON_INFERIORITY|This is a single-group, of outcome measured at baseline and at 3 months. We hypothesized there would be an improvement or sustainability of the protective behaviours.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.28|TWO_SIDED|95.0|-0.12|0.39|||t-test, 2 sided|||This is a single-group study. Selected outcomes were measured at baseline (first interaction with the community popular opinion leader (POL) and 3 months after.||0.39|-0.12|0.28
73931477|NCT04646616|147392760|OTHER|Test of proportions|difference in proportion|-0.007|STANDARD_ERROR_OF_MEAN|0.04||0.85|TWO_SIDED|95.0|-0.08|0.07|||Test of proportions|||Two sample test of proportions, testing whether the proportion of participants who lack health access at baseline and 3 months is equal (null hypothesis)||0.07|-0.08|0.85
73931478|NCT04646616|147392761|OTHER|Test of proportions.|difference in proportion|0.07|STANDARD_ERROR_OF_MEAN|0.58||0.19|TWO_SIDED|95.0|-0.04|0.19|||Test of proportions|||Test of proportions. Testing whether the proportion of participants who had a SAVAME factor at baseline and 3 months is equal (null hypothesis)||0.19|-0.04|0.19
74088537|NCT01138826|147730445|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|95.22|||||TWO_SIDED|90.0|88.16|102.84||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||102.84|88.16|
74088538|NCT01138826|147730445|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|96.77|||||TWO_SIDED|90.0|89.58|104.54||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||104.54|89.58|
74088539|NCT03360916|147730448|SUPERIORITY||Mean Difference (Net)|2.29|STANDARD_DEVIATION|125.59||0.953|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.9530
74088540|NCT03360916|147730448|SUPERIORITY||Mean Difference (Net)|-11.24|STANDARD_DEVIATION|130.12||0.7908|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.7908
74088541|NCT03360916|147730448|SUPERIORITY||Mean Difference (Net)|44.88|STANDARD_DEVIATION|105.19||0.1344|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.1344
74088542|NCT03360916|147730449|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.18||0.0005|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0005
74088543|NCT03360916|147730449|SUPERIORITY||Mean Difference (Net)|0.23|STANDARD_DEVIATION|0.21||0.0021|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0021
74088544|NCT03360916|147730449|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_DEVIATION|0.23||0.0025|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0025
74088545|NCT03053583|147730453|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||Posthoc analysis of POGO scores were compared using the Kruskall Wallis test with Mann-WHitney test for pairwise comparisons||||<0.05
73863363|NCT00110461|147273038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.7||||0.0074|TWO_SIDED|95.0|5.01|32.4|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||32.40|5.01|0.0074
73931479|NCT04646616|147392762|OTHER|Test of proportions.|difference in proportion|0.067|STANDARD_ERROR_OF_MEAN|0.06||0.23|TWO_SIDED|95.0|-0.04|0.18|||Test of proportions|||Test of proportions. Testing whether the proportion of participants who lack access to SAVAME related services at baseline and 3 months is equal (null hypothesis)||0.18|-0.04|0.23
73931480|NCT03049813|147392763|SUPERIORITY|||||||0.027||||||One-sided p value|Regression, Logistic|Adjusted for baseline year of study participation, problematic substance use, social cognition, community functioning, and negative symptoms - anergia||||||0.027
74088546|NCT03005067|147730465|OTHER||Mean Difference (Net)|0.137||||0.516|TWO_SIDED|95.0|-0.279|0.553||P-value was based on the Wald statistic Chi-Square test, from an ANCOVA model with treatment, center, and Day 1 dosing time stratification as factors and baseline NSS (Day 1 prior to the first dose) as a covariate.|ANCOVA||Difference of LS mean is 1146A Formulation Nasal Spray - Placebo Nasal Spray. 95% CI is for difference of LS means.|||0.553|-0.279|0.516
74088547|NCT00619359|147730473|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates (Fosaprepitant minus Aprepitant), calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the overall phase. Study had 90% power to detect non-inferiority for this outcome measure.|Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|3.7||||95.0|-4.1|3.3||||||||3.3|-4.1|
74088548|NCT00619359|147730474|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7.3 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the delayed phase.|Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.6||||95.0|-3.5|3.7||||||||3.7|-3.5|
74088549|NCT00619359|147730475|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥8.2 percentage points, fosaprepitant was considered at least as effective as aprepitant for No Vomiting in the overall phase.|Risk Difference (RD)|-1.7|STANDARD_ERROR_OF_MEAN|3.6||||95.0|-5.3|2.0||||||||2.0|-5.3|
74088550|NCT02296853|147730476|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|54.04|||||TWO_SIDED|90.0|41.98|69.56|||||Here, GLSM is geometric least square mean.|TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||69.56|41.98|
74088551|NCT02296853|147730476|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|63.06|||||TWO_SIDED|90.0|42.9|92.7||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||92.70|42.90|
73931481|NCT03049813|147392763|SUPERIORITY|||||||0.0765||||||1-sided p-value|Chi-squared|||||||0.0765
73931482|NCT03049813|147392764|SUPERIORITY|||||||0.062||||||One-sided p value|Regression, Cox|Adjusting for baseline year of study participation, problematic substance use, social cognition, community functioning, and negative symptoms anergia||||||0.062
73931483|NCT03049813|147392765|SUPERIORITY|||||||0.006||||||Adjusting for baseline year of study participation, problematic substance use, social cognition, community functioning, negative symptoms - anergia|Regression, Linear|||||||0.006
73931484|NCT03049813|147392766|SUPERIORITY|||||||0.013||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia). One-sided p value.|Regression, Linear|||||||0.013
73931485|NCT03049813|147392767|SUPERIORITY|||||||0.019||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia). One sided p-value.|Regression, Linear|||||||0.019
73931486|NCT03049813|147392768|SUPERIORITY|||||||0.692||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia).|Regression, Linear|||For this analysis, only participants who completed both pre-test and posttest were included. If someone completed a pre-test SSPA, but not a posttest SSPA, they were not included in the analysis.||||0.692
73931487|NCT00550836|147392770|SUPERIORITY|||||||0.36|||||||Log Rank|||It was calculated that 39 participants randomized in a 1:1 fashion between the 2 arms would have 80% to detect a difference in median survival of 6 vs. 9.7 months for GE vs. PGE respectively with a minimum follow up of 6 months. Sample size was determined using a 1-sided log-rank test at alpha=0.20.||||0.36
73931488|NCT00550836|147392771|OTHER|||||||1|||||||Fisher Exact|||||||1.0
73931489|NCT00550836|147392772|SUPERIORITY|||||||0.419|||||||Log Rank|||||||0.419
73931490|NCT00550836|147392773|OTHER|||||||0.36|||||||Log Rank|||||||0.36
73931491|NCT03120013|147392775|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73931492|NCT03120013|147392776|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
74029860|NCT03151148|147614050|SUPERIORITY||Geometric mean ratio (GMR)|508.45|||<|0.001|TWO_SIDED|95.0|223.113|1158.715|||Mixed Models Analysis|||"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|1158.715|223.113|<0.001
74029861|NCT03151148|147614050|SUPERIORITY||Geometric mean ratio (GMR)|107.86|||<|0.001|TWO_SIDED|95.0|45.568|255.313|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||255.313|45.568|<0.001
73931493|NCT03120013|147392777|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73931494|NCT03120013|147392778|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73931495|NCT03120013|147392779|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73931496|NCT03120013|147392780|SUPERIORITY||||||=|0.006|||||||ANCOVA|||||||=0.006
73931497|NCT03120013|147392781|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73931498|NCT03120013|147392782|SUPERIORITY||||||=|0.043|||||||ANCOVA|||||||=0.043
73931499|NCT02702401|147392790|SUPERIORITY||Hazard Ratio (HR)|0.775||||0.0186|TWO_SIDED|95.0|0.609|0.987|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.987|0.609|0.0186
73931500|NCT02702401|147392791|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.0238|TWO_SIDED|95.0|0.611|0.998|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.998|0.611|0.0238
73931501|NCT02702401|147392792|OTHER||Difference in Percent|13.8|||||TWO_SIDED|95.0|7.7|19.5|||||Miettinen \& Nurminen method stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||19.5|7.7|
73931502|NCT02702401|147392794|OTHER||Hazard Ratio (HR)|0.688||||0.0011|TWO_SIDED|95.0|0.54|0.877||One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Log Rank||Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.877|0.540|0.0011
73931503|NCT00247728|147392798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size is based on the paper 'Two-stage selection and testing design for comparative clinical trials', Thall, PF, Simon, R and Ellenberg, SS. Biometrika (1988),75,(2),303-310.||||||0.072||95.0|||||Chi-squared|||||||0.072
73931504|NCT00247728|147392798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size is based on the paper 'Two-stage selection and testing design for comparative clinical trials', Thall, PF, Simon, R and Ellenberg, SS. Biometrika (1988),75,(2),303-310.||||||0.298||95.0|||||Chi-squared|||||||0.298
73931505|NCT00247728|147392799|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.087||95.0|||||Mantel Haenszel|||||||0.087
73931506|NCT00247728|147392799|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.653||95.0|||||Mantel Haenszel|||||||0.653
73931507|NCT01868633|147392806|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
73931508|NCT02457325|147392828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||t-test, 2 sided|||||||0.192
73931509|NCT02457325|147392829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.457|||||||t-test, 2 sided|||||||0.457
73931510|NCT02457325|147392830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||t-test, 2 sided|||||||0.158
73931511|NCT02457325|147392831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.953|||||||t-test, 2 sided|||||||0.953
73931512|NCT02457325|147392832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||t-test, 2 sided|||||||0.693
73931513|NCT02457325|147392833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||t-test, 2 sided|||||||0.158
73931514|NCT02457325|147392834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||t-test, 2 sided|||||||0.192
73931515|NCT02457325|147392835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512|||||||t-test, 2 sided|||||||0.512
73931516|NCT02457325|147392836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.115|||||||t-test, 2 sided|||||||0.115
73931517|NCT02457325|147392837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||t-test, 2 sided|||||||0.730
73931518|NCT02457325|147392838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.835|||||||t-test, 2 sided|||||||0.835
73863364|NCT00110461|147273038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.55|||<|0.0001|TWO_SIDED|95.0|23.41|51.68|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||51.68|23.41|<0.0001
74029862|NCT03151148|147614050|SUPERIORITY||Geometric mean ratio (GMR)|16.09|||<|0.001|TWO_SIDED|95.0|7.058|36.657|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||36.657|7.058|<0.001
74029863|NCT03151148|147614051|SUPERIORITY||Geometric mean ratio (GMR)|142.89|||<|0.001|TWO_SIDED|95.0|58.484|349.119|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||349.119|58.484|<0.001
74029864|NCT03151148|147614051|SUPERIORITY||Geometric mean ratio (GMR)|35.19|||<|0.001|TWO_SIDED|95.0|14.402|85.972|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||85.972|14.402|<0.001
74029865|NCT03151148|147614051|SUPERIORITY||Geometric mean ratio (GMR)|41.64|||<|0.001|TWO_SIDED|95.0|17.043|101.739|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||101.739|17.043|<0.001
74029866|NCT03151148|147614051|SUPERIORITY||Geometric mean ratio (GMR)|3.61||||0.008|TWO_SIDED|95.0|1.395|9.33|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.330|1.395|0.008
74029867|NCT03151148|147614051|SUPERIORITY||Geometric mean ratio (GMR)|1.39||||0.474|TWO_SIDED|95.0|0.561|3.458|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.458|0.561|0.474
74029868|NCT03151148|147614051|SUPERIORITY||Geometric mean ratio (GMR)|266.87|||<|0.001|TWO_SIDED|95.0|108.86|654.231|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||654.231|108.860|<0.001
74029869|NCT03151148|147614051|SUPERIORITY||Geometric mean ratio (GMR)|51.07|||<|0.001|TWO_SIDED|95.0|20.907|124.768|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||124.768|20.907|<0.001
73863365|NCT00110461|147273039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4||||0.0009|TWO_SIDED|95.0|9.57|37.24|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||37.24|9.57|0.0009
73863366|NCT00110461|147273039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.96|||<|0.0001|TWO_SIDED|95.0|15.05|42.87|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||42.87|15.05|<0.0001
73971528|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.52||||0.015|TWO_SIDED|95.0|-0.938|-0.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.103|-0.938|0.0150
73971529|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.349||||0.1048|TWO_SIDED|95.0|-0.771|0.074|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.074|-0.771|0.1048
73971530|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.846|||<|0.0001|TWO_SIDED|95.0|-1.185|-0.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.507|-1.185|<.0001
73971531|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.873|||<|0.0001|TWO_SIDED|95.0|-1.127|-0.619|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.619|-1.127|<.0001
73971532|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.247||||0.2525|TWO_SIDED|95.0|-0.178|0.671|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.671|-0.178|0.2525
74008160|NCT03627767|147566483|SUPERIORITY||Difference in percentage|35.1|||<|0.0001|TWO_SIDED|95.0|28.1|42.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||42.0|28.1|< 0.0001
74029870|NCT03151148|147614051|SUPERIORITY||Geometric mean ratio (GMR)|74.96|||<|0.001|TWO_SIDED|95.0|30.686|183.125|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||183.125|30.686|<0.001
74091615|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.72|1.57|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 3||1.57|0.72|
73971533|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.098||||0.6503|TWO_SIDED|95.0|-0.33|0.527|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.527|-0.330|0.6503
73971534|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.239||||0.1759|TWO_SIDED|95.0|-0.109|0.588|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.588|-0.109|0.1759
73971535|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.867||||0.0293|TWO_SIDED|95.0|-1.674|-0.06|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.060|-1.674|0.0293
73971536|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.876||||0.0362|TWO_SIDED|95.0|-1.714|-0.038|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.038|-1.714|0.0362
73971537|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.139|||<|0.0001|TWO_SIDED|95.0|-1.809|-0.469|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.469|-1.809|<.0001
74008161|NCT03627767|147566483|SUPERIORITY||Difference in percentage|51.5|||<|0.0001|TWO_SIDED|95.0|44.6|58.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.4|44.6|< 0.0001
74008162|NCT03627767|147566483|SUPERIORITY||Difference in percentage|16.5|||||TWO_SIDED|95.0|8.1|24.8||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.8|8.1|
74039882|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.13|-0.44|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.44|-1.13|<.0001
73863367|NCT00110461|147273040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.66|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.66|-1.29|<0.0001
73931519|NCT01556204|147392857|SUPERIORITY_OR_OTHER|||||||0.71||||||This p-value is from a single comparison between two arms for operative time.|t-test, 2 sided|||Variance estimates for this power analysis were taken from Nezhat C, et al, 2010. We determined that 37 subjects in each arm were needed to detect a difference of ≥ 32 minutes in operating time between conventional and robotic surgery for endometriosis with 80% power and a significance level of 0.05.||||0.71
73971538|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.767||||0.0621|TWO_SIDED|95.0|-1.559|0.025|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.025|-1.559|0.0621
74008163|NCT03627767|147566483|SUPERIORITY||Difference in percentage|32.2|||<|0.0001|TWO_SIDED|95.0|25.2|39.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||39.2|25.2|< 0.0001
74088552|NCT02296853|147730476|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|94.42|||||TWO_SIDED|90.0|72.48|122.99||||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||122.99|72.48|
73931520|NCT01556204|147392858|SUPERIORITY_OR_OTHER|||||||0.53||||||This applies to Row title: Baseline|Mixed Models Analysis|||Secondary analysis for pain at baseline for robotic vs conventional laparoscopy for endometriosis.||||0.53
73931521|NCT01556204|147392858|SUPERIORITY_OR_OTHER|||||||0.53||||||This applies to Row title: 6-weeks|Mixed Models Analysis|||Pain scores at 6 weeks comparison between robotic and laparoscopy.||||0.53
73931522|NCT01556204|147392858|SUPERIORITY_OR_OTHER|||||||0.48||||||This applies to Row title: 6-months|Mixed Models Analysis|||Pain scores at 6 months for robotic vs laparoscopy.||||0.48
73931523|NCT02915744|147392888|OTHER||ESMO-MCBS (v1.0)|1.0|||||TWO_SIDED|||||||||||||
73931524|NCT00600821|147392919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.093||||0.639|TWO_SIDED|95.0|0.679|1.761||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.||1.761|0.679|0.639
73931525|NCT00600821|147392920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.117||||0.699|TWO_SIDED|95.0|0.739|1.689||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.||1.689|0.739|0.699
73931526|NCT00600821|147392921|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.676||||0.9422|TWO_SIDED|95.0|0.412|1.107|||Cochran-Mantel-Haenszel|||P-value was calculated using 1-sided Cochran-Mantel-Haenszel test stratified by gender and prior adjuvant therapy. Risk ratio in comparison to the Bevacizumab group was calculated assuming all other factors as constant.||1.107|0.412|0.9422
73931527|NCT04622254|147392955|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931528|NCT04622254|147392956|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931529|NCT04622254|147392957|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931530|NCT04622254|147392958|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931531|NCT04622254|147392959|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931532|NCT04622254|147392960|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931533|NCT04622254|147392961|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931534|NCT04622254|147392962|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931535|NCT04622254|147392963|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931536|NCT04622254|147392964|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73931537|NCT04622254|147392965|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931538|NCT04622254|147392966|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931539|NCT04622254|147392967|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931540|NCT04622254|147392967|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73931541|NCT04622254|147392968|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73931542|NCT04622254|147392968|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73931543|NCT01560624|147392971|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0275|TWO_SIDED|95.0|0.56|0.97|||Cox proportion-hazard model|||||0.97|0.56|0.0275
73931544|NCT01560624|147392971|SUPERIORITY|||||||0.0391|||||||Log Rank|||||||0.0391
73931545|NCT01560624|147392972|SUPERIORITY||Hodges Lehmann estimate location shift|7.0||||0.0913|TWO_SIDED|95.0|0.0|16.0|||ANCOVA|||||16.0|0|0.0913
73931546|NCT01560624|147392973|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73931547|NCT01560624|147392974|SUPERIORITY|||||||0.0028|||||||Fisher Exact|||||||0.0028
73931548|NCT03228680|147392981|NON_INFERIORITY|The pre-specified non-inferiority (NI) margin was -3.0 oocytes. The NI was evaluated based on the two-sided 95% CI from the ANOVA on 'number of oocytes retrieved' with treatment and AMH stratum as fixed factors.|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-2.3|-0.1|||||If the lower bound of 95% CI was well above pre-specified NI limit of -3.0 oocytes, then NI of FE 999049 to FOLLISTIM with respect to number of oocytes retrieved in women undergoing controlled ovarian stimulation would be demonstrated|Mean number of oocytes retrieved.||-0.1|-2.3|
73931549|NCT03228680|147392982|OTHER||Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-7.5|10.6|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with at least one gestational sac 5-6 weeks after transfer.||10.6|-7.5|
73863368|NCT00110461|147273040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.39|-0.7|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.70|-1.39|<0.0001
73863369|NCT00110461|147273041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.002|TWO_SIDED|95.0|-1.04|-0.24|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.24|-1.04|0.0020
73863370|NCT00110461|147273041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0001|TWO_SIDED|95.0|-1.19|-0.41|||Cochran-Mantel-Haenszel|||||-0.41|-1.19|0.0001
73863371|NCT00110461|147273042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.001|TWO_SIDED|95.0|-0.96|-0.26|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.26|-0.96|0.0010
73863372|NCT00110461|147273042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0053|TWO_SIDED|95.0|-0.85|-0.16|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.16|-0.85|0.0053
73863373|NCT00110461|147273043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.1726|TWO_SIDED|95.0|-0.64|0.11|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||0.11|-0.64|0.1726
73931550|NCT03228680|147392983|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-9.5|9.6|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with positive beta-hCG.||9.6|-9.5|
73931551|NCT03228680|147392984|OTHER||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-6.7|10.8|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with vital pregnancy.||10.8|-6.7|
73931552|NCT03228680|147392985|OTHER||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-8.9|12.8|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of implanted embryos 5-6 weeks after transfer.||12.8|-8.9|
73931553|NCT03228680|147392987|SUPERIORITY|||||||0.244||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with blastocyst transfer cancellation.||||0.244
73931554|NCT03228680|147392988|SUPERIORITY|||||||0.254||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with \<4 oocytes retrieved (low response).||||0.254
73931555|NCT03228680|147392988|SUPERIORITY|||||||0.041||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 4-7 oocytes retrieved (moderate response).||||0.041
73931556|NCT03228680|147392988|SUPERIORITY|||||||0.705||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 8-14 oocytes retrieved (targeted response).||||0.705
73931557|NCT03228680|147392988|SUPERIORITY|||||||0.183||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 15-19 oocytes retrieved (hyperresponse).||||0.183
73931558|NCT03228680|147392988|SUPERIORITY|||||||0.03||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with \>= (more than equal to) 20 oocytes retrieved (severe hyperresponse).||||0.030
73931559|NCT03228680|147392989|SUPERIORITY|||||||0.893||||||P-value was based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \< 15 pmol/L (\<4 oocytes retrieved)||||0.893
73931560|NCT03228680|147392989|SUPERIORITY|||||||0.002||||||P-value was based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \>= 15 pmol/L (\>=15 oocytes retrieved)||||0.002
73931561|NCT03228680|147392989|SUPERIORITY|||||||0.021||||||P-value based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \>= 15 pmol/L (\>=20 oocytes retrieved)||||0.021
73931562|NCT03228680|147392991|SUPERIORITY|||||||0.017||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with early OHSS (any grade).||||0.017
73931563|NCT03228680|147392991|SUPERIORITY|||||||0.035||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (moderate/severe).||||0.035
73863374|NCT00110461|147273043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0113|TWO_SIDED|95.0|-0.89|-0.12|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.12|-0.89|0.0113
73863375|NCT00110461|147273044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.67|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.67|-1.31|<0.0001
73863376|NCT00110461|147273044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.39|-0.72|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.72|-1.39|<0.0001
73931564|NCT03228680|147392991|SUPERIORITY|||||||0.006||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (any grade) and/or preventive interventions.||||0.006
73863377|NCT00110461|147273045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.003|TWO_SIDED|95.0|-1.04|-0.22|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.22|-1.04|0.0030
73863378|NCT00110461|147273045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0001|TWO_SIDED|95.0|-1.18|-0.4|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.40|-1.18|0.0001
73863379|NCT00364533|147273062|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|91.4|||<|0.001||95.0|49.77|133.07|||ANCOVA|||The study was terminated and did not reach the planned sample size.||133.07|49.77|<0.001
73863380|NCT00364533|147273062|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|81.5|||<|0.001||95.0|38.66|124.29|||ANCOVA|||The study was terminated and did not reach the planned sample size.||124.29|38.66|<0.001
73931565|NCT03228680|147392991|SUPERIORITY|||||||0.009||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (moderate/severe) and/or preventive interventions.||||0.009
73931566|NCT03228680|147392992|SUPERIORITY|||||||0.968||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with late OHSS (any grade).||||0.968
73931567|NCT03228680|147392992|SUPERIORITY|||||||0.582||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with late OHSS (moderate/severe).||||0.582
73931568|NCT03228680|147392993|SUPERIORITY|||||||0.198||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of follicles on stimulation Day 6 was analyzed.||||0.198
73931569|NCT03228680|147392994|SUPERIORITY|||||||0.036||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of follicles at end-of-stimulation was analyzed.||||0.036
73931570|NCT03228680|147392995|SUPERIORITY|||||||0.592||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The average size of 3 largest follicles was analyzed.||||0.592
73931571|NCT03228680|147392996|SUPERIORITY|||||||0.286||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The average size of 3 largest follicles was analyzed.||||0.286
73931572|NCT03228680|147392997|SUPERIORITY|||||||0.395||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The fertilization rate (number of oocytes with 2 pronuclei divided by the number of oocytes retrieved) was analyzed.||||0.395
73931573|NCT03228680|147392998|SUPERIORITY|||||||0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of embryos on Day 3 was analyzed.||||0.001
73931574|NCT03228680|147392998|SUPERIORITY|||||||0.004||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of good-quality embryos on Day 3 was analyzed.||||0.004
73931575|NCT03228680|147392999|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of blastocysts on Day 5 was analyzed.||||<.001
73931576|NCT03228680|147392999|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of good-quality blastocysts on Day 5 was analyzed.||||<0.001
73931577|NCT03228680|147393000|SUPERIORITY||Mean ratio|1.03||||0.228|TWO_SIDED|95.0|0.98|1.09||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of FSH on stimulation Day 6.||1.09|0.98|0.228
73931578|NCT03228680|147393000|SUPERIORITY||Mean ratio|0.97||||0.777|TWO_SIDED|95.0|0.81|1.17||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of LH on stimulation Day 6.||1.17|0.81|0.777
73931579|NCT03228680|147393001|SUPERIORITY||Mean ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.84|0.94||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of FSH at end-of-stimulation.||0.94|0.84|<0.001
73931580|NCT03228680|147393001|SUPERIORITY||Mean ratio|1.17||||0.057|TWO_SIDED|95.0|1.0|1.39||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of LH at end-of-stimulation.||1.39|1.00|0.057
74008164|NCT03627767|147566483|SUPERIORITY||Difference in percentage|46.9|||<|0.0001|TWO_SIDED|95.0|39.9|53.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.8|39.9|< 0.0001
73931581|NCT03228680|147393002|SUPERIORITY||Mean ratio|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of estradiol on stimulation Day 6.||0.93|0.71|0.002
73931582|NCT03228680|147393003|SUPERIORITY||Mean ratio|0.85||||0.003|TWO_SIDED|95.0|0.76|0.95||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of estradiol at end-of-stimulation.||0.95|0.76|0.003
73931583|NCT03228680|147393004|SUPERIORITY||Mean ratio|1.02||||0.814|TWO_SIDED|95.0|0.89|1.16||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of progesterone on stimulation Day 6.||1.16|0.89|0.814
73931584|NCT03228680|147393005|SUPERIORITY||Mean ratio|0.78|||<|0.001|TWO_SIDED|95.0|0.68|0.88||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of progesterone levels at end-of-stimulation.||0.88|0.68|<0.001
73931585|NCT03228680|147393006|SUPERIORITY||Mean ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.73|0.92||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin A on stimulation Day 6.||0.92|0.73|<0.001
73863381|NCT00364533|147273062|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|81.5|||<|0.001||95.0|39.21|123.8|||ANCOVA|||The study was terminated and did not reach the planned sample size.||123.80|39.21|<0.001
74088553|NCT02296853|147730477|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|45.1|||||TWO_SIDED|90.0|31.66|64.25||||||TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||64.25|31.66|
73863382|NCT00364533|147273062|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|82.4|||<|0.001||95.0|38.96|125.88|||ANCOVA|||The study was terminated and did not reach the planned sample size.||125.88|38.96|<0.001
73863383|NCT02855944|147273072|SUPERIORITY||Cox Proportional Hazard|0.639||||0.001|TWO_SIDED|95.0|0.489|0.835|||Regression, Cox|||||0.835|0.489|0.0010
73931586|NCT03228680|147393007|SUPERIORITY||Mean ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.72|0.88||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin A at end-of-stimulation.||0.88|0.72|<0.001
73931587|NCT03228680|147393008|SUPERIORITY||Mean ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin B on stimulation Day 6.||0.93|0.75|<0.001
73931588|NCT03228680|147393009|SUPERIORITY||Mean ratio|0.88||||0.027|TWO_SIDED|95.0|0.79|0.99||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin B at end-of-stimulation.||0.99|0.79|0.027
73971539|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.447||||0.5259|TWO_SIDED|95.0|-1.246|0.352|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.352|-1.246|0.5259
73971540|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.085|||<|0.0001|TWO_SIDED|95.0|-1.736|-0.435|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.435|-1.736|<.0001
73971541|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.112|||<|0.0001|TWO_SIDED|95.0|-1.532|-0.693|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.693|-1.532|<.0001
73971542|NCT04800211|147483694|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.054||||0.8248|TWO_SIDED|95.0|-0.535|0.427|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.427|-0.535|0.8248
74008165|NCT03627767|147566483|SUPERIORITY||Difference in percentage|14.2|||||TWO_SIDED|95.0|5.9|22.6||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.6|5.9|
73863384|NCT02855944|147273073|SUPERIORITY||Cox Proportional Hazard|0.665||||0.0017|TWO_SIDED|95.0|0.516|0.858|||Regression, Cox|||||0.858|0.516|0.0017
73863385|NCT02855944|147273076|SUPERIORITY||Cox Proportional Hazard|0.589||||0.0401|TWO_SIDED|95.0|0.356|0.976|||Regression, Cox|||||0.976|0.356|0.0401
73931589|NCT03228680|147393010|SUPERIORITY|||||||0.694||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of stimulation days at end-of-stimulation.||||0.694
74029871|NCT03151148|147614051|SUPERIORITY||Geometric mean ratio (GMR)|26.06|||<|0.001|TWO_SIDED|95.0|10.262|66.169|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||66.169|10.262|<0.001
73931590|NCT04456699|147393045|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.9774|TWO_SIDED|95.0|1.0|1.97|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.97|1.00|0.9774
73931591|NCT04456699|147393045|SUPERIORITY||Hazard Ratio (HR)|1.75||||0.9993|TWO_SIDED|95.0|1.23|2.49|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||2.49|1.23|0.9993
73931592|NCT04456699|147393046|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1527|TWO_SIDED|95.0|0.54|1.21|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.21|0.54|0.1527
73931593|NCT04456699|147393046|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.2491|TWO_SIDED|95.0|0.59|1.3|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.30|0.59|0.2491
73931594|NCT04456699|147393047|SUPERIORITY||Difference in Percentage|-0.2||||0.5272|TWO_SIDED|95.0|-7.0|6.5|||Miettinen and Nurminen|Based on stratified Miettinen \& Nurminen method. One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by prior FOLFOX/CAPOX + Bev induction response, cycles and mutation status.|||6.5|-7.0|0.5272
73931595|NCT04456699|147393047|SUPERIORITY||Difference in Percentage|-3.2||||0.902|TWO_SIDED|95.0|-9.7|2.3|||Miettinen & Nurminen|Based on stratified Miettinen \& Nurminen method. One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by prior FOLFOX/CAPOX + Bev induction response, cycles and mutation status.|||2.3|-9.7|0.9020
73931596|NCT02915029|147393072|SUPERIORITY|The primary hypothesis being tested was that the intervention will increase patient activation.|Mean Difference (Net)|8.7||||0.01|TWO_SIDED|95.0|1.9|15.5|||ANCOVA|Primary outcome was change in PAM total score, adjusted for baseline level. Adjusting for family clustering with generalized estimated equations.|This reflects the between-group difference for the within-person change scores in PAM total score adjusting for baseline values per person.|Group 1(usual care) is the comparison group, group 2 is the intervention group.|Applied generalized estimating equations (GEE) to account for within family (household) clustering.|15.5|1.9|0.01
73931597|NCT00086580|147393094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.467|0.795|||Regression, Cox|Cox proportional hazards model was stratified by Rai Stage Group||||0.795|0.467|<0.001
74088554|NCT02296853|147730477|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|89.88|||||TWO_SIDED|90.0|64.77|124.72||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||124.72|64.77|
74091616|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.88||||||95.0|0.54|1.42|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 7F||1.42|0.54|
73957777|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.512|STANDARD_ERROR_OF_MEAN|0.36||0.1554|TWO_SIDED|95.0|-1.219|0.195|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.195|-1.219|0.1554
73957778|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.889|STANDARD_ERROR_OF_MEAN|0.354||0.0124|TWO_SIDED|95.0|-1.585|-0.193|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.193|-1.585|0.0124
73957779|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.914|STANDARD_ERROR_OF_MEAN|0.412||0.0268|TWO_SIDED|95.0|-1.723|-0.106|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.106|-1.723|0.0268
73957780|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.681|STANDARD_ERROR_OF_MEAN|0.427||0.1113|TWO_SIDED|95.0|-1.519|0.158|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.158|-1.519|0.1113
73931598|NCT00086580|147393095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.178|TWO_SIDED|95.0|-0.03|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in overall response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of Overall Response.||0.15|-0.03|0.178
73931599|NCT00086580|147393095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.018|TWO_SIDED|95.0|0.02|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in complete response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of complete response (CR).||0.15|0.02|0.018
73971543|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|2.821||||0.0002|TWO_SIDED|95.0|1.369|4.273|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||4.273|1.369|0.0002
73971544|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.468|||<|0.0001|TWO_SIDED|95.0|1.85|5.086|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||5.086|1.850|<.0001
73971545|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|2.245||||0.0022|TWO_SIDED|95.0|0.812|3.679|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||3.679|0.812|0.0022
74088555|NCT02296853|147730477|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|82.16|||||TWO_SIDED|90.0|56.58|119.31||"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||119.31|56.58|
74088556|NCT02296853|147730478|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|51.2|||||TWO_SIDED|90.0|40.11|65.36||||||TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||65.36|40.11|
74091617|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.68|1.8|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 7F||1.80|0.68|
73971546|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.329|||<|0.0001|TWO_SIDED|95.0|1.768|4.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||4.891|1.768|<.0001
74008166|NCT03627767|147566483|SUPERIORITY||Difference in percentage|25.5|||<|0.0001|TWO_SIDED|95.0|18.5|32.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||32.5|18.5|< 0.0001
74008167|NCT03627767|147566483|SUPERIORITY||Difference in percentage|42.5|||<|0.0001|TWO_SIDED|95.0|35.3|49.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||49.7|35.3|< 0.0001
74008168|NCT03627767|147566483|SUPERIORITY||Difference in percentage|17.1|||||TWO_SIDED|95.0|8.6|25.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|8.6|
73971547|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.399|||<|0.0001|TWO_SIDED|95.0|2.252|4.545|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||4.545|2.252|<.0001
73971548|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|1.25||||0.0761|TWO_SIDED|95.0|-0.132|2.633|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||2.633|-0.132|0.0761
73971549|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.778||||0.0211|TWO_SIDED|95.0|0.269|3.286|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||3.286|0.269|0.0211
73931600|NCT00086580|147393096|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.648||||0.042|TWO_SIDED|95.0|0.449|0.937||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group||||0.937|0.449|0.042
73931601|NCT00086580|147393097|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.562|||<|0.001|TWO_SIDED|95.0|0.42|0.752|||Regression, Cox|Cox regression model stratified by Rai Stage Group.||||0.752|0.420|<0.001
73931602|NCT00086580|147393099|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.718||||0.021|TWO_SIDED|95.0|0.543|0.951|||Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group.||||0.951|0.543|0.021
73931603|NCT00086580|147393107|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.75||||0.102|TWO_SIDED|95.0|0.531|1.059|||Regression, Cox|||||1.059|0.531|0.102
73931604|NCT00086580|147393108|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.443|||<|0.001|TWO_SIDED|95.0|0.292|0.671|||Regression, Cox|||||0.671|0.292|<0.001
74008169|NCT03627767|147566484|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.0|0.0|
74008170|NCT03627767|147566484|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions. P-value was adjusted by disease severity at baseline and randomization strata.||0.0|0.0|
73931605|NCT00086580|147393109|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.066||||0.819|TWO_SIDED|95.0|0.619|1.836|||Regression, Cox|Cox proportional hazards model||||1.836|0.619|0.819
74008171|NCT03627767|147566484|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.0|0.0|
73863386|NCT02855944|147273077|SUPERIORITY||Cox Proportional Hazard|0.564||||0.024|TWO_SIDED|95.0|0.343|0.927|||Regression, Cox|||||0.927|0.343|0.0240
73863387|NCT03242018|147273097|SUPERIORITY||Difference in Least Square (LS) Means|-0.29|STANDARD_ERROR_OF_MEAN|0.173||0.0962|TWO_SIDED|95.0|-0.628|0.051|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.051|-0.628|0.0962
73931606|NCT00086580|147393110|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.416|||<|0.001|TWO_SIDED|95.0|0.25|0.69|||Regression, Cox|Cox proportional hazards model||||0.690|0.250|<0.001
73931607|NCT00086580|147393113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.014|TWO_SIDED|95.0|0.01|0.08|||Cochran-Mantel-Haenszel|CMH chi-square test for a difference in response rates between treatments stratified by Rai Stage Group.||||0.08|0.01|0.014
73931608|NCT01959581|147393141|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Repeated measures ANOVA||||<.05
73931609|NCT00780572|147393143|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9396||||0.668|TWO_SIDED|95.0|0.7068|1.249|||Regression, Cox|||||1.2490|0.7068|0.6680
73931610|NCT00395044|147393145|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Mixed Models Analysis|||||||.029
73931611|NCT01469065|147393152|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|84.87|||||TWO_SIDED|90.0|78.16|92.15||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test. Formal statistical inference was not performed thus p value was not reported.||92.15|78.16|
73863388|NCT03242018|147273098|SUPERIORITY||Difference in LS Means|0.05|STANDARD_ERROR_OF_MEAN|0.196||0.8124|TWO_SIDED|95.0|-0.338|0.431|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.431|-0.338|0.8124
73863389|NCT03242018|147273099|SUPERIORITY||Difference in LS Means|-0.361|STANDARD_ERROR_OF_MEAN|0.6033||0.5501|TWO_SIDED|95.0|-1.5431|0.822|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.||0.8220|-1.5431|0.5501
73863390|NCT03242018|147273099|SUPERIORITY||Difference in LS Means|-0.714|STANDARD_ERROR_OF_MEAN|0.5298||0.1779|TWO_SIDED|95.0|-1.7524|0.3246|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.||0.3246|-1.7524|0.1779
73863391|NCT03242018|147273100|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|0.703||0.2432|TWO_SIDED|95.0|-2.197|0.557|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||0.557|-2.197|0.2432
73863392|NCT03242018|147273100|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.715||0.0487|TWO_SIDED|95.0|-2.81|-0.008|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||-0.008|-2.810|0.0487
73863393|NCT03242018|147273101|SUPERIORITY||Difference in LS Means|-2.14|STANDARD_ERROR_OF_MEAN|2.515||0.3954|TWO_SIDED|95.0|-7.066|2.792|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||2.792|-7.066|0.3954
73863394|NCT03242018|147273101|SUPERIORITY||Difference in LS Means|-4.4|STANDARD_ERROR_OF_MEAN|2.442||0.0716|TWO_SIDED|95.0|-9.185|0.386|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.386|-9.185|0.0716
73863395|NCT03242018|147273102|SUPERIORITY||Difference in LS Means|-3.24|STANDARD_ERROR_OF_MEAN|2.103||0.1232|TWO_SIDED|95.0|-7.365|0.881|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.881|-7.365|0.1232
74029872|NCT03151148|147614051|SUPERIORITY||Geometric mean ratio (GMR)|3.41||||0.007|TWO_SIDED|95.0|1.397|8.338|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.338|1.397|0.007
74029873|NCT03151148|147614052|SUPERIORITY||Geometric mean ratio (GMR)|51.1|||<|0.001|TWO_SIDED|95.0|21.692|120.379|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||120.379|21.692|<0.001
74029874|NCT03151148|147614052|SUPERIORITY||Geometric mean ratio (GMR)|12.87|||<|0.001|TWO_SIDED|95.0|5.463|30.317|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||30.317|5.463|<0.001
73863396|NCT03242018|147273102|SUPERIORITY||Difference in LS Means|-5.36|STANDARD_ERROR_OF_MEAN|2.077||0.0098|TWO_SIDED|95.0|-9.433|-1.292|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.292|-9.433|0.0098
73863397|NCT03242018|147273103|SUPERIORITY||Percent Difference|-20.37||||0.222|TWO_SIDED|95.0|-44.75|14.77|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.||14.77|-44.75|0.222
74029875|NCT03151148|147614052|SUPERIORITY||Geometric mean ratio (GMR)|11.46|||<|0.001|TWO_SIDED|95.0|4.863|26.986|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||26.986|4.863|<0.001
73863398|NCT03242018|147273103|SUPERIORITY||Percent Difference|-21.17||||0.1965|TWO_SIDED|95.0|-45.05|13.1|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.||13.10|-45.05|0.1965
73931612|NCT01469065|147393152|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|89.8|||||TWO_SIDED|90.0|82.69|97.53||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.53|82.69|
73931613|NCT01469065|147393152|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|87.15|||||TWO_SIDED|90.0|80.27|94.63||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.63|80.27|
73931614|NCT01469065|147393152|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|78.28|||||TWO_SIDED|90.0|72.06|85.03||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||85.03|72.06|
73931615|NCT01469065|147393165|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|82.69|||||TWO_SIDED|90.0|76.06|89.9||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||89.90|76.06|
73931616|NCT01469065|147393165|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|85.39|||||TWO_SIDED|90.0|78.6|92.77||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.77|78.60|
73931617|NCT01469065|147393165|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|85.37|||||TWO_SIDED|90.0|78.59|92.76||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.76|78.59|
73931618|NCT01469065|147393165|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|75.82|||||TWO_SIDED|90.0|69.78|82.39||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||82.39|69.78|
73931619|NCT01469065|147393165|SUPERIORITY_OR_OTHER||Difference between Test and Reference|-35.84|||||TWO_SIDED|90.0|-52.89|-18.78||||||Treatment difference and 90% confidence interval (CI) were based on adjusted geometric mean.||-18.78|-52.89|
73931620|NCT01469065|147393166|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|86.72|||||TWO_SIDED|90.0|81.13|92.7||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.70|81.13|
73931621|NCT01469065|147393166|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|91.13|||||TWO_SIDED|90.0|85.24|97.44||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.44|85.24|
73931622|NCT01469065|147393166|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|87.05|||||TWO_SIDED|90.0|81.44|93.04||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||93.04|81.44|
73931623|NCT01469065|147393166|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|77.95|||||TWO_SIDED|90.0|72.91|83.34||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||83.34|72.91|
73931624|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|100.04|||||TWO_SIDED|90.0|92.7|107.96||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.96|92.70|
73931625|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|99.44|||||TWO_SIDED|90.0|92.04|107.43||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.43|92.04|
74091618|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.59|1.54|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 19A||1.54|0.59|
74091619|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.32|||||TWO_SIDED|95.0|0.81|2.15|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 19A||2.15|0.81|
73863399|NCT03242018|147273104|SUPERIORITY||Percentage Difference|3.2||||0.242|TWO_SIDED|95.0|-2.17|8.66|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||8.66|-2.17|0.2420
73863400|NCT03242018|147273104|SUPERIORITY||Percentage Difference|6.5||||0.0513|TWO_SIDED|95.0|0.04|12.93|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||12.93|0.04|0.0513
73863401|NCT03242018|147273105|SUPERIORITY||Percentage Difference|12.0||||0.0066|TWO_SIDED|95.0|3.48|20.61|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||20.61|3.48|0.0066
73863402|NCT03242018|147273105|SUPERIORITY||Percentage Difference|13.0||||0.0043|TWO_SIDED|95.0|4.28|21.75|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||21.75|4.28|0.0043
73863403|NCT00903331|147273130|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.9631|TWO_SIDED|95.0|-0.09|0.08|||Wilcoxon Rank Sum|||The null hypothesis was that there was no difference between ACT-064922 and placebo for the change in FVC from baseline to the end of Period 1. The aim was to detect a placebo-corrected change in FVC of ≥ 0.1 L (Standard Deviation = 0.2 L) at a two-sided 0.05 type 1 error level and 80% power.||0.08|-0.09|0.9631
73863404|NCT00903331|147273131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.118||||0.7056|TWO_SIDED|95.0|0.626|1.996|||Log Rank|||||1.996|0.626|0.7056
74029876|NCT03151148|147614052|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.058|TWO_SIDED|95.0|0.971|6.024|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.024|0.971|0.058
74029877|NCT03151148|147614052|SUPERIORITY||Geometric mean ratio (GMR)|0.75||||0.526|TWO_SIDED|95.0|0.315|1.805|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.805|0.315|0.526
74029878|NCT03151148|147614052|SUPERIORITY||Geometric mean ratio (GMR)|55.53|||<|0.001|TWO_SIDED|95.0|23.49|131.279|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||131.279|23.490|<0.001
74029879|NCT03151148|147614052|SUPERIORITY||Geometric mean ratio (GMR)|11.78|||<|0.001|TWO_SIDED|95.0|5.0|27.755|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||27.755|5.000|<0.001
74029880|NCT03151148|147614052|SUPERIORITY||Geometric mean ratio (GMR)|23.17|||<|0.001|TWO_SIDED|95.0|9.833|54.579|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||54.579|9.833|<0.001
74029881|NCT03151148|147614052|SUPERIORITY||Geometric mean ratio (GMR)|11.05|||<|0.001|TWO_SIDED|95.0|4.516|27.052|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||27.052|4.516|<0.001
74091620|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.65|||||TWO_SIDED|95.0|0.85|3.23|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 22F||3.23|0.85|
74029882|NCT03151148|147614052|SUPERIORITY||Geometric mean ratio (GMR)|2.43||||0.042|TWO_SIDED|95.0|1.031|5.724|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.724|1.031|0.042
73931626|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|101.67|||||TWO_SIDED|90.0|94.1|109.84||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||109.84|94.10|
73931627|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|96.82|||||TWO_SIDED|90.0|89.69|104.52||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.52|89.69|
73931628|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|95.85|||||TWO_SIDED|90.0|88.82|103.44||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||103.44|88.82|
73971550|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|1.57||||0.3841|TWO_SIDED|95.0|-0.951|4.092|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||4.092|-0.951|0.3841
73971551|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.69||||0.3934|TWO_SIDED|95.0|-1.084|4.464|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||4.464|-1.084|0.3934
73971552|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.995||||0.7782|TWO_SIDED|95.0|-1.505|3.494|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||3.494|-1.505|0.7782
74008172|NCT03627767|147566484|SUPERIORITY||Difference in percentage|42.7|||<|0.0001|TWO_SIDED|95.0|35.3|50.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.1|35.3|< 0.0001
74029883|NCT00494871|147614058|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.0|Hazard Ratio (HR)|1.11||||0.025|TWO_SIDED|95.0|0.87|1.42|||Regression, Cox|||||1.42|0.87|0.025
74029884|NCT00494871|147614059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.24|1.0||||||||1.00|0.24|
74029885|NCT00494871|147614060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.34|1.22||||||||1.22|0.34|
74029886|NCT00494871|147614061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.41|1.34||||||||1.34|0.41|
74029887|NCT00494871|147614062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.22|0.98||||||||0.98|0.22|
74029888|NCT00494871|147614063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.06|15.85||||||||15.85|0.06|
74029889|NCT00494871|147614064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.93|||||TWO_SIDED|95.0|0.3|28.16||||||||28.16|0.30|
74029890|NCT00494871|147614065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.97|||||TWO_SIDED|95.0|0.6|14.7||||||||14.70|0.60|
74029891|NCT00494871|147614066|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.16|1.4||||||||1.40|0.16|
74029892|NCT00494871|147614067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.43|4.31||||||||4.31|0.43|
74029893|NCT00494871|147614068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.5|1.43||||||||1.43|0.50|
74029894|NCT00494871|147614069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.92|1.56||||||||1.56|0.92|
74088557|NCT02296853|147730478|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|62.04|||||TWO_SIDED|90.0|41.92|91.82||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||91.82|41.92|
73931629|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|98.71|||||TWO_SIDED|90.0|91.37|106.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||106.64|91.37|
73931630|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|99.72|||||TWO_SIDED|90.0|92.3|107.73||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.73|92.30|
73931631|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|94.49|||||TWO_SIDED|90.0|87.53|102.1||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.10|87.53|
73931632|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|93.43|||||TWO_SIDED|90.0|86.5|100.91||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.91|86.50|
73931633|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|92.71|||||TWO_SIDED|90.0|85.81|100.15||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.15|85.81|
73931634|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|94.08|||||TWO_SIDED|90.0|87.08|101.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||101.64|87.08|
73931635|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|87.74|||||TWO_SIDED|90.0|81.2|94.81||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.81|81.20|
73931636|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|96.91|||||TWO_SIDED|90.0|89.72|104.67||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.67|89.72|
73931637|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|96.05|||||TWO_SIDED|90.0|88.9|103.76||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||103.76|88.90|
73931638|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|99.63|||||TWO_SIDED|90.0|92.21|107.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.64|92.21|
73931639|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|94.5|||||TWO_SIDED|90.0|87.46|102.11||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.11|87.46|
74088558|NCT02296853|147730478|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|93.28|||||TWO_SIDED|90.0|72.62|119.8||||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||119.8|72.62|
74088559|NCT03233958|147730481|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.24|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
74088560|NCT03233958|147730482|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|5.55|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
74088561|NCT03233958|147730483|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.54||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
73931640|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|86.75|||||TWO_SIDED|90.0|80.32|93.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||93.69|80.32|
73931641|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|87.87|||||TWO_SIDED|90.0|81.34|94.93||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.93|81.34|
73931642|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|91.35|||||TWO_SIDED|90.0|84.55|98.7||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||98.70|84.55|
73931643|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|88.6|||||TWO_SIDED|90.0|82.0|95.74||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||95.74|82.00|
73931644|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|90.45|||||TWO_SIDED|90.0|83.75|97.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.69|83.75|
73971553|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.552||||0.4576|TWO_SIDED|95.0|-1.171|4.274|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||4.274|-1.171|0.4576
73971554|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.621||||0.0849|TWO_SIDED|95.0|-0.224|3.466|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.466|-0.224|0.0849
73971555|NCT04800211|147483695|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.139||||0.9016|TWO_SIDED|95.0|-2.064|2.341|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||2.341|-2.064|0.9016
74008173|NCT03627767|147566484|SUPERIORITY||Difference in percentage|55.4|||<|0.0001|TWO_SIDED|95.0|49.1|61.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.7|49.1|< 0.0001
74008174|NCT03627767|147566484|SUPERIORITY||Difference in percentage|12.9|||||TWO_SIDED|95.0|7.9|17.9||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||17.9|7.9|
74029895|NCT02433210|147614099|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 clearance beta 2 microglobilin Optiflux vs Revaclear.||||<0.001
73931645|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|90.45|||||TWO_SIDED|90.0|84.03|98.08||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||98.08|84.03|
73971556|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.587||||0.0004|TWO_SIDED|95.0|2.511|8.662|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.662|2.511|0.0004
73971557|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.556||||0.1141|TWO_SIDED|95.0|-0.62|5.732|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.732|-0.620|0.1141
73971558|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.536||||0.0007|TWO_SIDED|95.0|2.367|8.705|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.705|2.367|0.0007
73971559|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|6.629|||<|0.0001|TWO_SIDED|95.0|3.68|9.577|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||9.577|3.680|<.0001
74008175|NCT03627767|147566484|SUPERIORITY||Difference in percentage|45.5|||<|0.0001|TWO_SIDED|95.0|37.9|53.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.0|37.9|< 0.0001
74008176|NCT03627767|147566484|SUPERIORITY||Difference in percentage|63.0|||<|0.0001|TWO_SIDED|95.0|56.4|69.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.5|56.4|< 0.0001
74029896|NCT02433210|147614099|SUPERIORITY||||||<|0.001||||||The p value is not adjusted for multiple comparisons and a p\<0.05 is considered significant.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance beta 2 microglobulin Optiflux vs ELISIO.||||<0.001
73931646|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|94.75|||||TWO_SIDED|90.0|87.69|102.34||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.34|87.69|
73931647|NCT01469065|147393167|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|93.18|||||TWO_SIDED|90.0|86.17|100.77||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.77|86.17|
73931648|NCT01469065|147393168|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|112.83|||||TWO_SIDED|90.0|99.84|127.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||127.50|99.84|
73863405|NCT00257660|147273132|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.84|||<|0.0001|TWO_SIDED|95.0|-12.94|-4.74||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the analysis at Week 4 excludes the scores for the 7 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-4.74|-12.94|<0.0001
73931649|NCT01469065|147393168|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|102.11|||||TWO_SIDED|90.0|90.78|114.85||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||114.85|90.78|
73931650|NCT01469065|147393168|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|111.04|||||TWO_SIDED|90.0|98.5|125.18||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||125.18|98.50|
73931651|NCT01469065|147393168|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|96.73|||||TWO_SIDED|90.0|85.46|109.48||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||109.48|85.46|
73931652|NCT01469065|147393169|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|107.13|||||TWO_SIDED|90.0|98.69|116.3||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||116.30|98.69|
73931653|NCT01469065|147393169|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|92.57|||||TWO_SIDED|90.0|85.26|100.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.50|85.26|
73931654|NCT01469065|147393169|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|96.07|||||TWO_SIDED|90.0|88.51|104.27||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.27|88.51|
73931655|NCT01469065|147393169|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|91.7|||||TWO_SIDED|90.0|84.38|99.65||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||99.65|84.38|
73931656|NCT02144675|147393174|OTHER||||||<|0.05|||||||Regression, Cox|||||||<.05
73931657|NCT01458171|147393209|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.45||||||||0.450||
73931658|NCT01458171|147393209|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.523||||||||0.523||
73931659|NCT01696032|147393216|SUPERIORITY|||||||0.0654|||||||Log Rank|||||||0.0654
73931660|NCT01192152|147393234|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares means|1.045|||||TWO_SIDED|90.0|1.025|1.065|||||Ratio = Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.||1.065|1.025|
73931661|NCT01192152|147393234|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|103.05||||||95.0||||||||Geometric least squares means for Treatment B||||
73931662|NCT01192152|147393234|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|98.61||||||95.0||||||||Geometric least squares means for Treatment A||||
73931663|NCT01192152|147393235|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.035|||||TWO_SIDED|90.0|1.009|1.062|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||1.062|1.009|
73931664|NCT01192152|147393235|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|101.16||||||95.0||||||||Geometric least squares means for Treatment B||||
73931665|NCT01192152|147393235|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|97.72||||||95.0||||||||Geometric least squares means for Treatment A||||
73931666|NCT01192152|147393237|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares mean|0.999|||||TWO_SIDED|90.0|0.948|1.053|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.||1.053|0.948|
73931667|NCT01192152|147393237|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|24.85||||||95.0||||||||Geometric least squares means for Treatment B||||
73931668|NCT01192152|147393237|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|24.88||||||95.0||||||||Geometric least squares means for Treatment A||||
74088562|NCT03233958|147730484|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.18||||0.076|TWO_SIDED||||||ANOVA|||||||0.076
73931669|NCT01192152|147393254|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.894|||||TWO_SIDED|90.0|0.833|0.959|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.||0.959|0.833|
73931670|NCT01192152|147393254|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|8713.4||||||95.0||||||||Geometric least squares mean for Treatment B||||
73931671|NCT01192152|147393254|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|9746.3||||||95.0||||||||Geometric least squares mean for Treatment A||||
73931672|NCT01192152|147393255|SUPERIORITY_OR_OTHER||ratio of geometric least squares means|0.906|||||TWO_SIDED|90.0|0.848|0.968|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||0.968|0.848|
73931673|NCT01192152|147393255|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|8377.8||||||95.0||||||||Geometric least squares means for Treatment B||||
73931674|NCT01192152|147393255|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|9246.8||||||95.0||||||||Geometric least squares mean for Treatment A||||
73931675|NCT01192152|147393257|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.917|||||TWO_SIDED|90.0|0.859|0.98|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.||0.980|0.859|
73931676|NCT01192152|147393257|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|1055.9||||||95.0||||||||Geometric least squares means for Treatment B||||
73931677|NCT01192152|147393257|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|1151.2||||||95.0||||||||Geometric least squares means for Treatment A||||
73931678|NCT02203591|147393270|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73931679|NCT02203591|147393270|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73931680|NCT02203591|147393270|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73931681|NCT02203591|147393270|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73931682|NCT02203591|147393270|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73931683|NCT02203591|147393270|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73931684|NCT02203591|147393270|OTHER|95% confidence interval generation|Mean value|81.1|||||TWO_SIDED|95.0|75.6|86.6||||||||86.6|75.6|
73931685|NCT02203591|147393270|OTHER|95% confidence interval generation|Mean value|81.7|||||TWO_SIDED|95.0|76.3|87.1||||||||87.1|76.3|
73931686|NCT02203591|147393270|OTHER|95% confidence interval generation|Mean value|83.2|||||TWO_SIDED|95.0|77.9|88.4||||||||88.4|77.9|
73931687|NCT02203591|147393270|OTHER|95% confidence interval generation|Mean value|38.9|||||TWO_SIDED|95.0|32.3|45.6||||||||45.6|32.3|
73931688|NCT02203591|147393270|OTHER|95% confidence interval generation|Mean value|46.9|||||TWO_SIDED|95.0|40.1|53.7||||||||53.7|40.1|
73931689|NCT02203591|147393270|OTHER|95% confidence interval generation|Mean value|53.0|||||TWO_SIDED|95.0|46.3|59.6||||||||59.6|46.3|
73931690|NCT02203591|147393271|NON_INFERIORITY|A non-inferior margin of 0.5 log10/cm\^2|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.57|-0.1|||||3M CHG/IPA C - Inguinal minus ChloraPrep - Inguinal|||-0.10|-0.57|
73931691|NCT02203591|147393271|NON_INFERIORITY|A non-inferior margin of 0.5 log10/cm\^2|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|97.5|-0.44|0.74|||||3M CHG/IPA CH - Inguinal minus ChloraPrep - Inguinal|Since there are two investigational products a Hochberg step-up procedure was used to adjust for multiplicity.||0.74|-0.44|
73931692|NCT02203591|147393272|OTHER|Calculate mean value|Mean value|2.83|STANDARD_DEVIATION|0.85|||TWO_SIDED|||||||||||||
73931693|NCT02203591|147393272|OTHER|Calculate mean value|Mean value|2.86|STANDARD_DEVIATION|0.9|||TWO_SIDED|||||||||||||
73931694|NCT02203591|147393272|OTHER|Calculate mean value|Mean value|2.83|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
73931695|NCT02203591|147393272|OTHER|Calculate mean value|Mean value|1.0|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
73931696|NCT02203591|147393272|OTHER|Calculate mean value|Mean value|3.46|STANDARD_DEVIATION|1.31|||TWO_SIDED|||||||||||||
73931697|NCT02203591|147393272|OTHER|Calculate mean value|Mean value|3.49|STANDARD_DEVIATION|1.33|||TWO_SIDED|||||||||||||
73931698|NCT02203591|147393272|OTHER|Calculate mean value|Mean value|3.69|STANDARD_DEVIATION|1.29|||TWO_SIDED|||||||||||||
73931699|NCT02203591|147393272|OTHER|Calculate mean value|Mean value|1.23|STANDARD_DEVIATION|0.73|||TWO_SIDED|||||||||||||
73931700|NCT02203591|147393273|OTHER|Calculate mean value|Mean value|2.78|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
73931701|NCT02203591|147393273|OTHER|Calculate mean value|Mean value|2.73|STANDARD_DEVIATION|1.0|||TWO_SIDED|||||||||||||
73931702|NCT02203591|147393273|OTHER|Calculate mean value|Mean value|2.75|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
73931703|NCT02203591|147393273|OTHER|Calculate mean value|Mean value|0.76|STANDARD_DEVIATION|0.81|||TWO_SIDED|||||||||||||
73931704|NCT02203591|147393273|OTHER|Calculate mean value|Mean value|2.84|STANDARD_DEVIATION|1.19|||TWO_SIDED|||||||||||||
73931705|NCT02203591|147393273|OTHER|Calculate mean value|Mean value|2.99|STANDARD_DEVIATION|1.12|||TWO_SIDED|||||||||||||
74088563|NCT03233958|147730485|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.51||||0.147|TWO_SIDED||||||ANOVA|||||||0.147
74088564|NCT03233958|147730486|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|1.07||||0.197|TWO_SIDED||||||ANOVA|||||||0.197
73931706|NCT02203591|147393273|OTHER|Calculate mean value|Mean value|3.17|STANDARD_DEVIATION|1.24|||TWO_SIDED|||||||||||||
73931707|NCT02203591|147393273|OTHER|Calculate mean value|Mean value|1.01|STANDARD_DEVIATION|0.67|||TWO_SIDED|||||||||||||
73931708|NCT02203591|147393274|OTHER|Calculate mean value|Mean value|0.8|STANDARD_DEVIATION|0.84|||TWO_SIDED|||||||||||||
73931709|NCT02203591|147393274|OTHER|Calculate mean value|Mean value|0.74|STANDARD_DEVIATION|0.79|||TWO_SIDED|||||||||||||
73931710|NCT02203591|147393274|OTHER|Calculate mean value|Mean value|0.81|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
73931711|NCT02203591|147393274|OTHER|Calculate mean value|Mean value|2.65|STANDARD_DEVIATION|0.89|||TWO_SIDED|||||||||||||
73931712|NCT02203591|147393274|OTHER|Calculate mean value|Mean value|2.76|STANDARD_DEVIATION|1.2|||TWO_SIDED|||||||||||||
73931713|NCT02203591|147393274|OTHER|Calculate mean value|Mean value|2.73|STANDARD_DEVIATION|1.22|||TWO_SIDED|||||||||||||
73931714|NCT02203591|147393274|OTHER|Calculate mean value|Mean value|2.58|STANDARD_DEVIATION|1.18|||TWO_SIDED|||||||||||||
73931715|NCT02203591|147393274|OTHER|Calculate mean value|Mean value|4.85|STANDARD_DEVIATION|0.75|||TWO_SIDED|||||||||||||
73931716|NCT02203591|147393275|OTHER|Calculate mean value|Mean value|0.85|STANDARD_DEVIATION|0.95|||TWO_SIDED|||||||||||||
73931717|NCT02203591|147393275|OTHER|Calculate mean value|Mean value|0.87|STANDARD_DEVIATION|0.98|||TWO_SIDED|||||||||||||
73931718|NCT02203591|147393275|OTHER|Calculate mean value|Mean value|0.89|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
73931719|NCT02203591|147393275|OTHER|Calculate mean value|Mean value|2.88|STANDARD_DEVIATION|0.7|||TWO_SIDED|||||||||||||
73931720|NCT02203591|147393275|OTHER|Calculate mean value|Mean value|3.39|STANDARD_DEVIATION|1.1|||TWO_SIDED|||||||||||||
74029897|NCT02433210|147614099|SUPERIORITY||||||=|0.178||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 clearance beta 2 microglobulin Revaclear vs ELISIO..||||=0.178
74029898|NCT02433210|147614099|SUPERIORITY||||||=|0.016||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Optiflux vs Revaclear.||||=0.016
74029899|NCT02433210|147614099|SUPERIORITY||||||=|0.033||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Optiflux vs ELISIO.||||=0.033
74088565|NCT03233958|147730487|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
73931721|NCT02203591|147393275|OTHER|Calculate mean value|Mean value|3.21|STANDARD_DEVIATION|1.04|||TWO_SIDED|||||||||||||
73931722|NCT02203591|147393275|OTHER|Calculate mean value|Mean value|3.08|STANDARD_DEVIATION|1.14|||TWO_SIDED|||||||||||||
73931723|NCT02203591|147393275|OTHER|Calculate mean value|Mean value|5.08|STANDARD_DEVIATION|0.68|||TWO_SIDED|||||||||||||
73931724|NCT02203591|147393276|OTHER|Calculate mean value|Mean value|3.63|STANDARD_DEVIATION|0.46|||TWO_SIDED|||||||||||||
73931725|NCT02203591|147393276|OTHER|Calculate mean value|Mean value|3.61|STANDARD_DEVIATION|0.48|||TWO_SIDED|||||||||||||
73931726|NCT02203591|147393276|OTHER|Calculate mean value|Mean value|3.64|STANDARD_DEVIATION|0.49|||TWO_SIDED|||||||||||||
73931727|NCT02203591|147393276|OTHER|Calculate mean value|Mean value|3.64|STANDARD_DEVIATION|0.53|||TWO_SIDED|||||||||||||
73931728|NCT02203591|147393276|OTHER|Calculate mean value|Mean value|6.23|STANDARD_DEVIATION|0.6|||TWO_SIDED|||||||||||||
73931729|NCT02203591|147393276|OTHER|Calculate mean value|Mean value|6.22|STANDARD_DEVIATION|0.56|||TWO_SIDED|||||||||||||
73931730|NCT02203591|147393276|OTHER|Calculate mean value|Mean value|6.27|STANDARD_DEVIATION|0.62|||TWO_SIDED|||||||||||||
73931731|NCT02203591|147393276|OTHER|Calculate mean value|Mean value|6.09|STANDARD_DEVIATION|0.63|||TWO_SIDED|||||||||||||
73931732|NCT03022617|147393309|SUPERIORITY||Mean Difference (Final Values)|21.5|STANDARD_DEVIATION|10.89||0.05|TWO_SIDED||||||t-test, 2 sided|||||||.05
73931733|NCT00515827|147393338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.546||95.0||||P-value is 2-sided and is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.546
73931734|NCT01009099|147393353|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||ANCOVA|Co-variates included in the analysis were time walked on the constant workrate test at baseline and adherence (sessions completed/expected).||The outcomes compared were time walked on the constant workrate treadmill test measured in minutes.||||0.63
73931735|NCT01833403|147393354|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73931736|NCT01032135|147393360|OTHER|||||||0.11|||||||Chi-squared|||||||0.11
73931737|NCT01032135|147393361|OTHER|||||||0.02|||||||Chi-squared|||||||0.02
73931738|NCT01032135|147393362|OTHER|||||||0.005|||||||Chi-squared|||||||0.005
73931739|NCT01032135|147393367|OTHER||Odds Ratio (OR)|0.4||||0.0007|TWO_SIDED|95.0|0.23|0.68|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.68|0.23|0.0007
73931740|NCT01032135|147393367|OTHER||Odds Ratio (OR)|0.54||||0.16|TWO_SIDED|95.0|0.23|1.27|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.27|0.23|0.16
73931741|NCT01032135|147393367|OTHER||Odds Ratio (OR)|1.12||||0.79|TWO_SIDED|95.0|0.48|2.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.60|0.48|0.79
73931742|NCT01032135|147393372|OTHER||Odds Ratio (OR)|-1.08||||0.009|TWO_SIDED|95.0|-1.87|-0.29|||Chi-squared|||The statistical analyses used data from all follow up assessments.||-0.29|-1.87|0.009
73931743|NCT01032135|147393372|OTHER||Odds Ratio (OR)|-0.84||||0.23|TWO_SIDED|95.0|-2.2|0.52|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.52|-2.20|0.23
73931744|NCT01032135|147393372|OTHER||Odds Ratio (OR)|-0.34||||0.58|TWO_SIDED|95.0|-1.52|0.85|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.85|-1.52|0.58
73931745|NCT01032135|147393377|OTHER||Odds Ratio (OR)|0.33||||0.0001|TWO_SIDED|95.0|0.19|0.58|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.58|0.19|0.0001
73931746|NCT01032135|147393377|OTHER||Odds Ratio (OR)|0.67||||0.36|TWO_SIDED|95.0|0.29|1.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.54|0.29|0.36
73863406|NCT00257660|147273133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.81|||<|0.0001||95.0|-12.91|-4.71||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 8 analysis excludes the scores for the 24 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-4.71|-12.91|<0.0001
73863407|NCT00257660|147273134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.12||||0.019||95.0|-7.55|-0.68||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 12 analysis excludes the scores for the 27 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-0.68|-7.55|0.019
73863408|NCT00257660|147273135|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.2|||<|0.001||95.0|-24.0|-6.4||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 4 subjects (and 13 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-6.4|-24.0|<0.001
73863409|NCT00257660|147273136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.2|||<|0.001||95.0|-22.3|-6.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS CD symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 3 subjects (and 8 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-6.1|-22.3|<0.001
73863410|NCT00257660|147273137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.95|||<|0.001||95.0|-25.8|-8.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-8.1|-25.8|<0.001
73863411|NCT00257660|147273138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.0|||<|0.001||95.0|-24.2|-7.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-7.8|-24.2|<0.001
73863412|NCT00257660|147273139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.05||||0.007||95.0|-19.0|-3.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-3.1|-19.0|0.007
73863413|NCT00257660|147273140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.05||||0.028||95.0|-13.3|-0.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-0.8|-13.3|0.028
73931747|NCT01032135|147393377|OTHER||Odds Ratio (OR)|1.43||||0.45|TWO_SIDED|95.0|0.58|3.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.||3.54|0.58|0.45
73931748|NCT01032135|147393382|OTHER||Odds Ratio (OR)|-1.09||||0.003|TWO_SIDED|95.0|-1.8|-0.39|||Chi-squared|||The statistical analyses used data from all follow up assessments.||-0.39|-1.80|0.003
73931749|NCT01032135|147393382|OTHER||Odds Ratio (OR)|0.02||||0.1|TWO_SIDED|95.0|-1.1|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.14|-1.10|0.10
73931750|NCT01032135|147393386|OTHER||Odds Ratio (OR)|0.66||||0.13|TWO_SIDED|95.0|0.38|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.14|0.38|0.13
73931751|NCT01032135|147393386|OTHER||Odds Ratio (OR)|0.83||||0.71|TWO_SIDED|95.0|0.33|2.12|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.12|0.33|0.71
73931752|NCT01032135|147393386|OTHER||Odds Ratio (OR)|1.48||||0.36|TWO_SIDED|95.0|0.64|3.4|||Chi-squared|||The statistical analyses used data from all follow up assessments.||3.40|0.64|0.36
73863414|NCT00257660|147273141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.65||||0.061||95.0|-0.17|7.47||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 mental health summary score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||7.47|-0.17|0.061
73863415|NCT00257660|147273142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.66||||0.002||95.0|1.73|7.58||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 physical health summary score, center and previous treatment by botulinum toxin or not were fitted in ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||7.58|1.73|0.002
73863416|NCT00257660|147273143|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|7.206|||<|0.0001||95.0|3.01|17.26||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|odds ratio|The odds ratio represents the odds of success on Dysport versus Placebo stratified for strata and country||The number of participants considered treatment successes was analysed using a logistic model with treatment, strata (naive or non-naive) and center as factors in the model.||17.26|3.01|<0.0001
73863417|NCT02449018|147273151|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.31||0.13|TWO_SIDED|90.0|-0.24|0.79|||ANCOVA|||||0.79|-0.24|0.130
73863418|NCT03995355|147273164|NON_INFERIORITY|Subjective overall comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least square mean difference|11.3|STANDARD_ERROR_OF_MEAN|4.44|||TWO_SIDED|95.0|2.6|20.1|||Linear Mixed Model Analysis||Least square mean difference was calculated as Test minus Control|||20.1|2.6|
74029900|NCT02433210|147614099|SUPERIORITY||||||=|0.935|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Revaclear vs ELISIO.||||=0.935
73863419|NCT03995355|147273165|NON_INFERIORITY|Subjective overall comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least square mean difference|2.6|STANDARD_ERROR_OF_MEAN|3.97|||TWO_SIDED|95.0|-5.3|10.4|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||10.4|-5.3|
73863420|NCT03995355|147273166|OTHER||Odds Ratio (OR)|0.967|||||TWO_SIDED|95.0|0.528|1.77|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control. No difference was concluded if 1 fall within the 95% confidence interval for the odds ratio.|||1.770|0.528|
73863421|NCT03995355|147273166|OTHER||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.61|2.203|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control. No difference was concluded if 1 fall within the 95% confidence interval for the odds ratio.|30-Day follow-up||2.203|0.610|
73863422|NCT03995355|147273167|OTHER||Odds Ratio (OR)|1.601|||||TWO_SIDED|95.0|0.178|19.616|||Fisher Exact||Odds ratio was calculated as Test over Control|||19.616|0.178|
73863423|NCT03995355|147273168|OTHER||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|3.73|||TWO_SIDED|95.0|0.7|15.4|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||15.4|0.7|
73863424|NCT03995355|147273169|OTHER||Mean Difference (Net)|9.3|STANDARD_ERROR_OF_MEAN|3.86|||TWO_SIDED|95.0|1.7|17.0|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||17.0|1.7|
73863425|NCT03426631|147273170|SUPERIORITY||Median Difference (Final Values)|-11.7||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.47
73931753|NCT01032135|147393389|OTHER||Odds Ratio (OR)|-0.13||||0.75|TWO_SIDED|95.0|-0.94|0.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.60|-0.94|0.75
73931754|NCT01032135|147393389|OTHER||Odds Ratio (OR)|-0.84||||0.16|TWO_SIDED|95.0|-1.98|0.3|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.30|-1.98|0.16
73931755|NCT01032135|147393389|OTHER||Odds Ratio (OR)|0.6||||0.42|TWO_SIDED|95.0|-0.85|2.04|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.04|-0.85|0.42
73931756|NCT02188485|147393393|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.72||0.278|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|Thwarted belonging (INQ-TB) at 10 week follow-up||||.278
73931757|NCT02188485|147393393|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.38||0.591|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|Perceived burden (INQ-PB) at 10-week follow-up||||.591
73931758|NCT02188485|147393394|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.52||0.511|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|||||.511
73931759|NCT02188485|147393395|SUPERIORITY||Mean Difference (Final Values)|-2.47|STANDARD_ERROR_OF_MEAN|0.85||0.014|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|||||.014
73931760|NCT01227512|147393422|SUPERIORITY_OR_OTHER|||||||0.9495||||||The alpha level was set at 0.05|Generalized Wilcoxon Test|Participants who used rescue therapy within first 7 days of treatment period were censored at time they started the rescue therapy.||||||0.9495
74088566|NCT03208673|147730504|SUPERIORITY||Ratio of Geometric mean|0.5628||||0.001|TWO_SIDED|95.0|0.4395|0.7204|||t-test, 2 sided|||||0.7204|0.4395|.001
73863426|NCT04971941|147273176|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|2.17||0.001|TWO_SIDED|95.0|0.4|2.1||This P value applies to comparison of IAN with and without DentalVibe|t-test, 2 sided|df =58||Sample size estimation from Nanitsos 2010: Using the P value from the paired T test with 61 degrees of freedom the T statistic calculated at 4.365. From mean difference 9.3 SD was calculated as 16.66 for an effect size of 0.558. This generated a sample size of 44 subjects, receiving 2 injections (1 with DV3 and 1 without), is necessary to attain 95% power for a paired t-test comparing the 2 pain measures at a two-tailed alpha level of 0.05. P value for IAN||2.1|0.4|0.001
73863427|NCT04971941|147273176|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_DEVIATION|1.75||0.02|TWO_SIDED|95.0|-1.7|-1.5|||t-test, 2 sided|df= 58||||-1.5|-1.7|0.02
73863428|NCT04971941|147273176|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.74||0.004|TWO_SIDED|95.0|0.4|2.1|||t-test, 2 sided|||||2.1|0.4|0.004
73863429|NCT04971941|147273177|SUPERIORITY||Mean Difference (Net)|4.0||||0.001|TWO_SIDED|14.0|0.4|4.8||This P value applies to comparing IAN with or with DV as measured by SSI tolerability/ability to endure|t-test, 2 sided|||||4.8|0.4|0.001
73863430|NCT04971941|147273177|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
73863431|NCT04971941|147273177|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
73863432|NCT04971941|147273177|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
73931761|NCT01227512|147393423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.146||95.0|-0.7|0.11||alpha level was set at 0.05. p-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA|Includes factors of treatment, study center and covariate baseline.||||0.11|-0.70|0.1460
74029901|NCT02433210|147614099|SUPERIORITY||||||=|0.463|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of urea nitrogen Optiflux vs Revaclaer.||||=0.463
74029902|NCT02433210|147614099|SUPERIORITY||||||=|0.392|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of urea nitrogen Optiflux vs ELISIO.||||=0.392
73863433|NCT04971941|147273177|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
73863434|NCT04971941|147273177|SUPERIORITY|||||||0.044|||||||t-test, 2 sided|||||||0.044
73863435|NCT04971941|147273177|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||||||0.023
73863436|NCT04971941|147273177|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
73863437|NCT04971941|147273177|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||0.053
73863438|NCT04971941|147273178|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||The null hypothesis is that there is no relation between use of DV and numb times. There were no studies from which to perform a power calculation for this outcome measure||||0.459
73863439|NCT00721175|147273179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2407407|STANDARD_ERROR_OF_MEAN|0.0920078||0.011|TWO_SIDED|95.0|-0.4210726|-0.0604089|||Two-sample test of proportion|||||-.0604089|-.4210726|0.011
73863440|NCT00721175|147273180|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||Log Rank|||||||0.0021
73863441|NCT00721175|147273182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278744|STANDARD_ERROR_OF_MEAN|0.0929622||0.004|TWO_SIDED|95.0|-0.4609466|-0.0965414|||Two-sample test of proportion|||||-.0965414|-.4609466|0.004
73863442|NCT01969721|147273187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.103|0.147||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.147|0.103|<0.0001
73863443|NCT01969721|147273187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.129|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.107|0.15||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.150|0.107|<0.0001
73931762|NCT01227512|147393424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.315||95.0|-0.57|0.19|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 24 hours post-dose.||0.19|-0.57|0.3150
73931763|NCT01227512|147393424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.5381||95.0|-0.57|0.3|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 72 hours post-dose.||0.30|-0.57|0.5381
73931764|NCT01227512|147393425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.2702||95.0|-0.73|0.21||P-value was derived from a Cochran-Mantel-Haenszel (CMH) row mean scores test.|Cochran-Mantel-Haenszel|||||0.21|-0.73|0.2702
74029903|NCT02433210|147614099|SUPERIORITY||||||=|0.597|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance urea nitrogen Revaclear vs ELISIO.||||=0.597
74029904|NCT02433210|147614099|SUPERIORITY||||||=|0.162|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Optiflux vs Revaclear.||||=0.162
74029905|NCT02433210|147614099|SUPERIORITY|||||||0.186|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Optiflux vs ELISIO.||||0.186
73863444|NCT01969721|147273187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.081|0.124||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.124|0.081|<0.0001
73863445|NCT01969721|147273187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.106|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.085|0.128||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.128|0.085|<0.0001
73863446|NCT01969721|147273188|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.061|0.103||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.103|0.061|<0.0001
73863447|NCT01969721|147273188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.065|0.107||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.107|0.065|<0.0001
73863448|NCT01969721|147273188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.045|0.086||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.086|0.045|<0.0001
73863449|NCT01969721|147273188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.048|0.09||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.090|0.048|<0.0001
73863450|NCT01969721|147273189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|0.022|0.071||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.071|0.022|0.0002
73931765|NCT01227512|147393426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.77||||0.0019||95.0|1.43|6.11||P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA|||||6.11|1.43|0.0019
73931766|NCT01227512|147393427|SUPERIORITY_OR_OTHER|||||||0.5128||||||p-value was derived from Generalized Wilcoxon test stratified by treatment. Participants who received rescue therapy were censored at the time of receiving rescue therapy.|Generalized Wilcoxon Test|||||||0.5128
74088567|NCT03208673|147730505|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|||Nasal||||0.025
74088568|NCT03208673|147730505|SUPERIORITY|||||||0.312|||||||t-test, 1 sided|||Temporal||||0.312
74088569|NCT03208673|147730506|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Comfort||||<0.001
74088570|NCT03208673|147730506|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Dry||||<0.001
74088571|NCT03208673|147730506|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Gritty||||<0.001
74088572|NCT03208673|147730506|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Vision||||<0.001
74088573|NCT03891329|147730508|OTHER|No comparison of two groups, just single arm design|SADE-free rate in the study group|0.98||||0.05|TWO_SIDED|95.0|0.9|1.0|||t-test, 2 sided|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Cor Family devices until the 3- month follow-up are counted for this primary endpoint.~The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||1|0.9|0.05
74088574|NCT03891329|147730509|OTHER|Kaplan-Meier method|||||||||||||||||The Kaplan-Meier method will be applied to estimate the 3-month SADE-free rate at 92 days after implantation (sensitivity analysis of the primary endpoint) and the 12-month SADE-free rate at 365 days after implantation.|||
74088575|NCT03176784|147730512|SUPERIORITY||Odds Ratio (OR)|0.9||||0.66|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.66
74088576|NCT03176784|147730512|SUPERIORITY||Odds Ratio (OR)|1.0||||0.85|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.4|0.7|.85
74088577|NCT03176784|147730512|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.4|0.7|1.00
74088578|NCT03176784|147730513|SUPERIORITY||Odds Ratio (OR)|1.2||||0.44|TWO_SIDED|95.0|0.8|1.7||Study site (Madison vs Milwaukee) was included as a covariate.|Regression, Logistic|||||1.7|0.8|.44
74088579|NCT03176784|147730513|SUPERIORITY||Odds Ratio (OR)|1.1||||0.61|TWO_SIDED|95.0|0.8|1.6|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.6|0.8|.61
73931767|NCT01227512|147393428|SUPERIORITY_OR_OTHER||Relative Risk|1.1||||0.5795||95.0|0.79|1.52||P-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel|||||1.52|0.79|0.5795
73931768|NCT01227512|147393429|SUPERIORITY_OR_OTHER||Relative Risk|0.33||||0.1568||95.0|0.07|1.65||p-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel|||||1.65|0.07|0.1568
73931769|NCT04497987|147393462|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.26|0.63|||Regression, Logistic|||||0.63|0.26|<0.001
74088580|NCT03176784|147730513|SUPERIORITY||Odds Ratio (OR)|1.4||||0.12|TWO_SIDED|95.0|0.9|2.0|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||2.0|0.9|.12
74088581|NCT03176784|147730514|SUPERIORITY||Odds Ratio (OR)|0.8||||0.43|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.5|.43
74088582|NCT03176784|147730514|SUPERIORITY||Odds Ratio (OR)|0.8||||0.37|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.5|.37
74088583|NCT03176784|147730514|SUPERIORITY||Odds Ratio (OR)|1.1||||0.81|TWO_SIDED|95.0|0.7|1.6|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.6|0.7|.81
73931770|NCT04497987|147393463|SUPERIORITY||Odds Ratio (OR)|0.43|||<|0.001|TWO_SIDED|95.0|0.27|0.67|||Regression, Logistic|||||0.67|0.27|<0.001
73931771|NCT04497987|147393464|SUPERIORITY||Odds Ratio (OR)|0.66||||0.021|TWO_SIDED|95.0|0.46|0.94|||Regression, Logistic|||||0.94|0.46|0.021
73931772|NCT00298038|147393488|SUPERIORITY|Analysis based on the overall comparison of time to the first breakthrough overt HE episode between rifaximin and placebo groups adjusting for analysis region, using the Cox proportional hazards model (Score test, \[that is, Log rank test stratified by analysis region\]) with a 2-sided test at a significance level of 0.05 under the proportional hazards assumption.|Hazard Ratio (HR)|0.421|||<|0.0001|TWO_SIDED|95.0|0.276|0.641|||Cox proportional hazards model|||||0.641|0.276|<0.0001
73931773|NCT02742103|147393519|OTHER||Rate difference (CSL112 - placebo)|-0.124|||||TWO_SIDED|95.0|-0.296|-0.005|||Newcombe-Wilson|||||-0.005|-0.296|
73931774|NCT02742103|147393520|OTHER||Rate difference (CSL112 - placebo)|-0.103|||||TWO_SIDED|95.0|-0.277|0.025|||Newcombe-Wilson|||||0.025|-0.277|
74088584|NCT03176784|147730515|SUPERIORITY||Odds Ratio (OR)|0.9||||0.65|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.65
74088585|NCT03176784|147730515|SUPERIORITY||Odds Ratio (OR)|0.9||||0.6|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.60
74088586|NCT03176784|147730515|SUPERIORITY||Odds Ratio (OR)|1.0||||0.86|TWO_SIDED|95.0|0.7|1.5|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.5|0.7|.86
74088587|NCT01258101|147730535|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to Arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|32.0|||||TWO_SIDED|95.0|10.5|53.5||||||||53.5|10.5|
74088588|NCT01258101|147730535|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-3.2|||||TWO_SIDED|95.0|-14.0|7.6||||||||7.6|-14.0|
74088589|NCT01258101|147730535|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|7.2|||||TWO_SIDED|95.0|-4.7|19.1||||||||19.1|-4.7|
74088590|NCT01258101|147730535|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-21.1|||||TWO_SIDED|95.0|-42.2|-0.1||||||||-0.1|-42.2|
74088591|NCT01258101|147730537|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||||0.2|-1.0|
74088592|NCT01258101|147730537|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-2.6|||||TWO_SIDED|95.0|-6.4|1.3||||||||1.3|-6.4|
74088593|NCT01258101|147730537|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.4|1.4||||||||1.4|-1.4|
74088594|NCT01258101|147730537|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-0.5|1.7||||||||1.7|-0.5|
73971560|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.083||||0.0072|TWO_SIDED|95.0|1.118|7.047|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.047|1.118|0.0072
73971561|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.688||||0.0023|TWO_SIDED|95.0|1.691|7.686|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.686|1.691|0.0023
73971562|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.112|||<|0.0001|TWO_SIDED|95.0|2.874|7.35|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.350|2.874|<.0001
73971563|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.777||||0.603|TWO_SIDED|95.0|-2.165|3.72|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.720|-2.165|0.6030
73971564|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.003||||0.5053|TWO_SIDED|95.0|-1.96|3.967|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.967|-1.960|0.5053
74008177|NCT03627767|147566484|SUPERIORITY||Difference in percentage|17.7|||||TWO_SIDED|95.0|10.7|24.7||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions||24.7|10.7|
74008178|NCT03627767|147566484|SUPERIORITY||Difference in percentage|41.0|||<|0.0001|TWO_SIDED|95.0|33.6|48.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.5|33.6|< 0.0001
74008179|NCT03627767|147566484|SUPERIORITY||Difference in percentage|58.3|||<|0.0001|TWO_SIDED|95.0|51.3|65.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||65.2|51.3|< 0.0001
74029906|NCT02433210|147614099|SUPERIORITY|No Significant difference.||||||0.624|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea nitrogen clearance Optiflux vs Revaclear.||||0.624
74088595|NCT01258101|147730545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.2667|TWO_SIDED||||||Regression, Cox|||||||0.2667
73863451|NCT01969721|147273189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.082||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.082|0.034|<0.0001
73863452|NCT01969721|147273189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.012||0.0007|TWO_SIDED|95.0|0.018|0.067||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.067|0.018|0.0007
73863453|NCT01969721|147273189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.029|0.078||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.078|0.029|<0.0001
73863454|NCT01969721|147273190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.039|STANDARD_ERROR_OF_MEAN|0.012||0.0007|TWO_SIDED|95.0|0.017|0.062||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.062|0.017|0.0007
73863455|NCT01969721|147273190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.043|STANDARD_ERROR_OF_MEAN|0.011||0.0002|TWO_SIDED|95.0|0.021|0.065||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.065|0.021|0.0002
73863456|NCT01969721|147273190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028|STANDARD_ERROR_OF_MEAN|0.011||0.0146|TWO_SIDED|95.0|0.006|0.051||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.051|0.006|0.0146
73863457|NCT01969721|147273190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.032|STANDARD_ERROR_OF_MEAN|0.011||0.0055|TWO_SIDED|95.0|0.009|0.054||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.054|0.009|0.0055
73931775|NCT02573324|147393556|SUPERIORITY||Cox Proportional Hazard|1.02||||0.633|TWO_SIDED|95.0|0.82|1.26||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|Terms abbreviated below: O6-methylguaninemethlytransferese (MGMT); Recursive Partitioning Analysis (RPA); EGFRde2-7 (EGFRvIII)||1.26|0.82|0.633
74088596|NCT01258101|147730545|SUPERIORITY_OR_OTHER|||||||0.9999|||||||Regression, Cox|||||||0.9999
74088597|NCT01258101|147730545|SUPERIORITY_OR_OTHER|||||||0.9891|||||||Regression, Cox|||||||0.9891
73863458|NCT01969721|147273191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.142|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.118|0.166||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.166|0.118|<0.0001
73863459|NCT01969721|147273191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.123|0.171||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.171|0.123|<0.0001
73863460|NCT01969721|147273191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.111|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.087|0.135||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.135|0.087|<0.0001
73863461|NCT01969721|147273191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.092|0.14||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.140|0.092|<0.0001
73863462|NCT02117349|147273211|OTHER||Odds Ratio (OR)|42.8|||=|0.001|TWO_SIDED|95.0|4.58|401.0||Study was terminated early at 55 randomized subjects, therefore p-value is considered nominal|Regression, Logistic|||Odds Ratio (OR) and Wald-based 95% Confidence intervals (CIs) are from logistic regression model comparing the response between treatment arms.||401.0|4.58|= 0.0010
73863463|NCT02265796|147273217|SUPERIORITY||||||>|0.05||||||the reported p value is for all between group comparisons of the SAQ domains.|t-test, 2 sided|||between group comparison for all SAQ domains||||>0.05
73863464|NCT02265796|147273217|SUPERIORITY||||||>|0.05||||||reported p value is for the physical limitation, angina frequency and treatment satisfaction domains|paired t test|||within group comparison of change from baseline||||>0.05
73863465|NCT02265796|147273217|SUPERIORITY||||||<|0.05||||||reported p value is for the angina stability and quality of life domains|paired t test|||within group comparison of change from baseline||||<0.05
73863466|NCT02265796|147273217|SUPERIORITY||||||>|0.05||||||reported p value is for the physical limitation and treatment satisfaction domains|paired t test|||within group comparison of change from baseline||||>0.05
73863467|NCT02265796|147273217|SUPERIORITY||||||<|0.05||||||reported p value is for the angina stability, angina frequency and quality of life domains|paired t test|||within group comparison of change from baseline||||<0.05
73863468|NCT02265796|147273218|SUPERIORITY|||||||0.58|||||||Fisher Exact|||"between group comparison for the excellent/good"||||0.58
73863469|NCT02265796|147273218|SUPERIORITY|||||||0.8|||||||Fisher Exact|||"Between group analysis for fair/poor"||||0.80
73863470|NCT02265796|147273218|SUPERIORITY|||||||0.5|||||||McNemar|||within group analysis of change from baseline for excellent/good||||0.50
73863471|NCT02265796|147273218|SUPERIORITY|||||||0.48|||||||McNemar|||within group comparison of change from baseline for fair/poor||||0.48
73863472|NCT02265796|147273218|SUPERIORITY|||||||0.19|||||||McNemar|||within group analysis of change from baseline for excellent/good||||0.19
73863473|NCT02265796|147273218|SUPERIORITY|||||||0.067|||||||McNemar|||within group comparison of change from baseline for fair/poor||||0.067
73863474|NCT02265796|147273219|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
73931776|NCT02573324|147393556|SUPERIORITY|||||||0.704||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.704
73957781|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.356||0.1305|TWO_SIDED|95.0|-1.24|0.16|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.160|-1.240|0.1305
73957782|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.571|STANDARD_ERROR_OF_MEAN|0.351||0.1043|TWO_SIDED|95.0|-1.261|0.118|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.118|-1.261|0.1043
73863475|NCT03938324|147273220|SUPERIORITY|||||||0.0034||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.0034
73863476|NCT03938324|147273221|SUPERIORITY|||||||0.5137||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.5137
73863477|NCT03938324|147273222|SUPERIORITY|||||||0.4107||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.4107
73863478|NCT03938324|147273223|SUPERIORITY|||||||0.1708||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.1708
73863479|NCT03938324|147273224|SUPERIORITY|||||||0.7982||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.7982
73863480|NCT05063539|147273250|SUPERIORITY||Posterior Mean Difference|1.68|||||TWO_SIDED|95.0|-0.375|3.771|||||Posterior mean difference with 95% credible interval is reported.|||3.771|-0.375|
73863481|NCT05063539|147273250|SUPERIORITY||Posterior Mean Difference|-3.2|||||TWO_SIDED|95.0|-5.354|-1.042|||||Posterior mean difference with 95% credible interval is reported.|||-1.042|-5.354|
73863482|NCT05063539|147273251|SUPERIORITY||Posterior Mean Difference|1.59|||||TWO_SIDED|95.0|-0.443|3.697|||||Posterior mean difference with 95% credible interval is reported.|||3.697|-0.443|
73931777|NCT02573324|147393557|SUPERIORITY||Cox Proportional Hazard|0.97||||0.504|TWO_SIDED|95.0|0.76|1.24||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|||1.24|0.76|0.504
73931778|NCT02573324|147393557|SUPERIORITY|||||||0.599||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.599
73931779|NCT02573324|147393558|SUPERIORITY||Cox Proportional Hazard|1.17||||0.773|TWO_SIDED|95.0|0.76|1.8||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|||1.80|0.76|0.773
73863483|NCT05063539|147273251|SUPERIORITY||Posterior Mean Difference|-5.07|||||TWO_SIDED|95.0|-7.277|-2.862||||||||-2.862|-7.277|
73863484|NCT05063539|147273252|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.32||0.665|TWO_SIDED|95.0|-0.763|0.488|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.488|-0.763|0.665
73863485|NCT05063539|147273252|SUPERIORITY||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.33||0.001|TWO_SIDED|95.0|0.435|1.736|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.736|0.435|0.001
73863486|NCT05063539|147273253|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.35||0.878|TWO_SIDED|95.0|-0.641|0.749|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.749|-0.641|0.878
73863487|NCT05063539|147273253|SUPERIORITY||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|0.615|2.05|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||2.050|0.615|<0.001
73863488|NCT05063539|147273254|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.99||0.252|TWO_SIDED|95.0|-3.073|0.811|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.811|-3.073|0.252
73863489|NCT05063539|147273254|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|1.03||0.825|TWO_SIDED|95.0|-2.252|1.797|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.797|-2.252|0.825
73863490|NCT05063539|147273255|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.09||0.733|TWO_SIDED|95.0|-2.527|1.779|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.779|-2.527|0.733
73863491|NCT05063539|147273255|SUPERIORITY||LS Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|1.13||0.143|TWO_SIDED|95.0|-0.565|3.877|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||3.877|-0.565|0.143
74029907|NCT02433210|147614099|SUPERIORITY|||||||0.732|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea nitrogen clearance Optiflux vs ELISIO.||||0.732
73863492|NCT05063539|147273256|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.0||0.86|TWO_SIDED|95.0|-1.802|2.158|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||2.158|-1.802|0.860
73863493|NCT05063539|147273256|SUPERIORITY||LS Mean Difference|-2.51|STANDARD_ERROR_OF_MEAN|1.04||0.017|TWO_SIDED|95.0|-4.567|-0.456|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-0.456|-4.567|0.017
73863494|NCT05063539|147273257|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.1||0.479|TWO_SIDED|95.0|-2.949|1.387|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.387|-2.949|0.479
73863495|NCT05063539|147273257|SUPERIORITY||LS Mean Difference|-4.01|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-6.239|-1.788|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-1.788|-6.239|<0.001
73863496|NCT05063539|147273258|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.53||0.259|TWO_SIDED|95.0|-0.445|1.642|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.642|-0.445|0.259
73863497|NCT05063539|147273258|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.55||0.324|TWO_SIDED|95.0|-1.629|0.541|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.541|-1.629|0.324
73863498|NCT05063539|147273259|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.57||0.749|TWO_SIDED|95.0|-0.946|1.313|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.313|-0.946|0.749
73863499|NCT05063539|147273259|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.59||0.029|TWO_SIDED|95.0|-2.462|-0.134|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-0.134|-2.462|0.029
73863500|NCT05063539|147273260|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.012||0.346|TWO_SIDED|95.0|-0.01|0.03|||ANCOVA|||Frontal||0.03|-0.01|0.346
73863501|NCT05063539|147273260|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.412|TWO_SIDED|95.0|-0.04|0.01|||ANCOVA|||Frontal||0.01|-0.04|0.412
73863502|NCT05063539|147273260|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.421|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||Parietal||0.02|-0.04|0.421
73863503|NCT05063539|147273260|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.014||0.08|TWO_SIDED|95.0|-0.05|0.0|||ANCOVA|||Parietal||0.00|-0.05|0.080
73863504|NCT05063539|147273260|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.021||0.192|TWO_SIDED|95.0|-0.07|0.01|||ANCOVA|||Lateral occipital||0.01|-0.07|0.192
73863505|NCT05063539|147273260|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.022||0.279|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||Lateral occipital||0.02|-0.07|0.279
73863506|NCT05063539|147273260|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.016||0.693|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||Lateral temporal||0.02|-0.04|0.693
73863507|NCT05063539|147273260|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.04|TWO_SIDED|95.0|-0.07|0.0|||ANCOVA|||Lateral temporal||-0.00|-0.07|0.040
73863508|NCT05063539|147273260|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.838|TWO_SIDED|95.0|-0.03|0.03|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.03|-0.03|0.838
73863509|NCT05063539|147273260|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.055|TWO_SIDED|95.0|-0.06|0.0|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.00|-0.06|0.055
73863510|NCT05063539|147273261|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.455|TWO_SIDED|95.0|-0.02|0.04|||ANCOVA|||Frontal||0.04|-0.02|0.455
73863511|NCT05063539|147273261|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.745|TWO_SIDED|95.0|-0.03|0.02|||ANCOVA|||Frontal||0.02|-0.03|0.745
73863512|NCT05063539|147273261|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.015||0.676|TWO_SIDED|95.0|-0.02|0.04|||ANCOVA|||Parietal||0.04|-0.02|0.676
73863513|NCT05063539|147273261|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.794|TWO_SIDED|95.0|-0.03|0.03|||ANCOVA|||Parietal||0.03|-0.03|0.794
73863514|NCT05063539|147273261|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.643|TWO_SIDED|95.0|-0.05|0.03|||ANCOVA|||Lateral occipital||0.03|-0.05|0.643
73863515|NCT05063539|147273261|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.021||0.88|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||Lateral occipital||0.04|-0.05|0.880
73863516|NCT05063539|147273261|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.017||0.844|TWO_SIDED|95.0|-0.04|0.03|||ANCOVA|||Lateral temporal||0.03|-0.04|0.844
73863517|NCT05063539|147273261|SUPERIORITY|Lateral temporal|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.017||0.388|TWO_SIDED|95.0|-0.05|0.02|||ANCOVA|||||0.02|-0.05|0.388
73863518|NCT05063539|147273261|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.016||0.815|TWO_SIDED|95.0|-0.03|0.04|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.04|-0.03|0.815
73863519|NCT05063539|147273261|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.017||0.562|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.02|-0.04|0.562
73863520|NCT05063539|147273262|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.024|<|0.001|TWO_SIDED|95.0|0.04|0.14|||Mixed Models Analysis|||Bilateral Hippocampus||0.14|0.04|<0.001
73863521|NCT05063539|147273262|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.08|0.18|||Mixed Models Analysis|||Bilateral Hippocampus||0.18|0.08|<0.001
74029908|NCT02433210|147614099|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea Nitrogen clearance Revaclear vs Optiflux.||||0.427
73931780|NCT02573324|147393558|SUPERIORITY|||||||0.74||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.740
73931781|NCT02573324|147393559|SUPERIORITY||Cox Proportional Hazard|0.95||||0.381|TWO_SIDED|95.0|0.71|1.27||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.27|0.71|0.381
73931782|NCT02573324|147393559|SUPERIORITY|||||||0.409||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.409
73931783|NCT02573324|147393560|SUPERIORITY||Cox Proportional Hazard|0.84||||0.029|TWO_SIDED|95.0|0.7|1.01||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.01|0.70|0.029
73931784|NCT02573324|147393561|SUPERIORITY||Cox Proportional Hazard|0.72||||0.002|TWO_SIDED|95.0|0.56|0.93||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||0.93|0.56|0.002
73931785|NCT02573324|147393562|SUPERIORITY||Cox Proportional Hazard|1.329||||0.994|TWO_SIDED|95.0|1.087|1.626||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.626|1.087|0.994
73931786|NCT02573324|147393563|SUPERIORITY||Cox Proportional Hazard|1.185||||0.938|TWO_SIDED|95.0|0.972|1.446||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.446|0.972|0.938
73931787|NCT02573324|147393564|SUPERIORITY||Cox Proportional Hazard|1.136||||0.814|TWO_SIDED|95.0|0.921|1.402||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.402|0.921|0.814
73931788|NCT02096835|147393597|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
73931789|NCT02096835|147393598|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
73931790|NCT02096835|147393599|SUPERIORITY_OR_OTHER|||||||0.503|TWO_SIDED||||||Chi-squared|||||||0.503
73931791|NCT02096835|147393600|SUPERIORITY_OR_OTHER|||||||0.571|TWO_SIDED||||||Chi-squared|||||||0.571
73931792|NCT03892889|147393602|OTHER||||||<|0.0001|TWO_SIDED|||||Paired t-test was used based on the prospective phase efficacy sample when applicable.|paired t-test|||||||<0.0001
73931793|NCT00023673|147393636|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Lung toxicity (\<Grade 3 vs. \>= Grade 3): Lung V20||||0.62
73931794|NCT00023673|147393636|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Lung V20||||0.22
73931795|NCT00023673|147393637|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|2-sided significance level = 0.05||Lung toxicity (\<Grade 3 vs. \>= Grade 3): Mean Lung Dose||||0.30
74029909|NCT02433210|147614099|SUPERIORITY|||||||0.379|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Optiflux vs Revaclear..||||0.379
73863522|NCT05063539|147273262|SUPERIORITY||LS Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.587|<|0.001|TWO_SIDED|95.0|-3.53|-1.21|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-1.21|-3.53|<0.001
73931796|NCT00023673|147393637|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Mean Lung Dose||||0.17
73931797|NCT00023673|147393637|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Mean Esophageal Dose||||0.08
73931798|NCT02660359|147393655|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025 and only the significant dose continued in the hierarchal testing strategy.|LS Mean Difference|-8.97||||0.0001|TWO_SIDED|95.0|-13.5|-4.44|||MMLM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-4.44|-13.5|0.0001
73931799|NCT02660359|147393655|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025 and only the significant dose continued in the hierarchal testing strategy.|LS Mean Difference|-9.76|||<|0.0001|TWO_SIDED|95.0|-14.41|-5.12|||MMLM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-5.12|-14.41|<0.0001
74088598|NCT04179019|147730582|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||The intra-individual, paired, 24h urine aldosterone excretion rate following 2 weeks of amlodipine therapy was compared to the baseline pre-treatment 24h urine aldosterone excretion rate. The null hypothesis was that amlodipine therapy would result in no change in the 24h urine aldosterone excretion rate. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.96
74088599|NCT04179019|147730583|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||The intra-individual, paired, plasma aldosterone concentration following 2 weeks of amlodipine therapy was compared to the baseline pre-treatment aldosterone concentration. The null hypothesis was that amlodipine therapy would result in no change in the plasma aldosterone value. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.29
74088600|NCT04179019|147730584|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||The intra-individual, paired, change in plasma aldosterone concentration in response to an acute dose of amlodipine (6h post-dose) was compared to the baseline pre-treatment response to an acute dose of amlodipine. The null hypothesis was that an acute amlodipine dose would result in no acute change in the plasma aldosterone levels. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.83
74088601|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.5|||||TWO_SIDED|90.0|-5.41|-1.59|||Mixed Models Analysis|||30 minutes postdose||-1.59|-5.41|
74088602|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.54|||||TWO_SIDED|90.0|-5.18|-1.89|||Mixed Models Analysis|||1 hour postdose||-1.89|-5.18|
74088603|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.1|||||TWO_SIDED|90.0|-5.77|-2.43|||Mixed Models Analysis|||1.5 hours postdose||-2.43|-5.77|
74088604|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.21|||||TWO_SIDED|90.0|-5.14|-1.28|||Mixed Models Analysis|||2 hours postdose||-1.28|-5.14|
74088605|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.46|||||TWO_SIDED|90.0|-4.41|-0.51|||Mixed Models Analysis|||2.5 hours postdose||-0.51|-4.41|
73863523|NCT05063539|147273262|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.611||0.008|TWO_SIDED|95.0|-2.84|-0.43|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-0.43|-2.84|0.008
74088606|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.91|||||TWO_SIDED|90.0|-2.84|1.03|||Mixed Models Analysis|||3 hours postdose||1.03|-2.84|
73863524|NCT05063539|147273262|SUPERIORITY||LS Mean Difference|8.17|STANDARD_ERROR_OF_MEAN|1.715|<|0.001|TWO_SIDED|95.0|4.79|11.56|||Mixed Models Analysis|||Bilateral Whole Brain||11.56|4.79|<0.001
73863525|NCT05063539|147273262|SUPERIORITY||LS Mean Difference|9.37|STANDARD_ERROR_OF_MEAN|1.804|<|0.001|TWO_SIDED|95.0|5.81|12.92|||Mixed Models Analysis|||Bilateral Whole Brain||12.92|5.81|<0.001
73863526|NCT05063539|147273263|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.023|<|0.001|TWO_SIDED|95.0|0.04|0.13|||Mixed Models Analysis|||Bilateral Hippocampus||0.13|0.04|<0.001
73863527|NCT05063539|147273263|SUPERIORITY|Bilateral Hippocampus|LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.023|<|0.001|TWO_SIDED|95.0|0.08|0.17|||Mixed Models Analysis|||||0.17|0.08|<0.001
74088607|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.62|||||TWO_SIDED|90.0|-2.53|1.29|||Mixed Models Analysis|||3.5 hours postdose||1.29|-2.53|
73863528|NCT05063539|147273263|SUPERIORITY||LS Mean Difference|-2.21|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.33|-1.08|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-1.08|-3.33|<0.001
73863529|NCT05063539|147273263|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.582||0.015|TWO_SIDED|95.0|-2.57|-0.28|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-0.28|-2.57|0.015
73863530|NCT05063539|147273263|SUPERIORITY||LS Mean Difference|7.17|STANDARD_ERROR_OF_MEAN|1.635|<|0.001|TWO_SIDED|95.0|3.95|10.4|||Mixed Models Analysis|||Bilateral Whole Brain||10.40|3.95|<0.001
73863531|NCT05063539|147273263|SUPERIORITY||LS Mean Difference|8.16|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|4.85|11.47|||Mixed Models Analysis|||Bilateral Whole Brain||11.47|4.85|<0.001
73863532|NCT04736628|147273280|OTHER||Mean Difference (Net)|-0.228||||0.0179|TWO_SIDED|95.0|-0.417|-0.04|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 1 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.040|-0.417|0.0179
74029910|NCT02433210|147614099|SUPERIORITY|||||||0.318|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Optiflux vs ELISIO.||||0.318
74029911|NCT02433210|147614099|SUPERIORITY||||||=|0.914|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Revaclear vs ELISIO.||||=0.914
74029912|NCT02433210|147614099|SUPERIORITY||||||=|0.623|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Optiflux vs Revaclear.||||=0.623
74029913|NCT02433210|147614099|SUPERIORITY||||||=|0.403|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Optiflux vs ELISIO.||||=0.403
74029914|NCT02433210|147614099|SUPERIORITY||||||=|0.85|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Revaclear vs ELISIO.||||=0.850
74088608|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.07|||||TWO_SIDED|90.0|-1.84|1.99|||Mixed Models Analysis|||4 hours postdose||1.99|-1.84|
73863533|NCT04736628|147273280|OTHER||Mean Difference (Net)|-0.209||||0.0307|TWO_SIDED|95.0|-0.398|-0.02|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 2 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.020|-0.398|0.0307
73863534|NCT04736628|147273280|OTHER||Mean Difference (Net)|-0.235||||0.0151|TWO_SIDED|95.0|-0.425|-0.046|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 3 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.046|-0.425|0.0151
73863535|NCT04736628|147273280|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0053|||||||MCP-Mod E-max model fit|Model assumption: 80% of the maximum effect is achieved at 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0053
73931800|NCT02660359|147393656|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|45.55||||0.0002|TWO_SIDED|95.0|6.09|340.69|||Generalised linear mixed model (GLMM)|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline- by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||340.69|6.09|0.0002
73931801|NCT02660359|147393656|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|31.69||||0.0009|TWO_SIDED|95.0|4.17|240.58|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||240.58|4.17|0.0009
73931802|NCT02660359|147393657|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.55||||0.0007|TWO_SIDED|95.0|1.72|7.34||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 600 U versus Placebo.||7.34|1.72|0.0007
73931803|NCT02660359|147393657|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|2.94||||0.0037|TWO_SIDED|95.0|1.43|6.07||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 800 U versus Placebo||6.07|1.43|0.0037
73931804|NCT02660359|147393657|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.98|||<|0.0001|TWO_SIDED|95.0|2.03|7.79||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement level: Dysport® 600 U versus Placebo||7.79|2.03|<0.0001
73931805|NCT02660359|147393657|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by- visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|2.73||||0.0034|TWO_SIDED|95.0|1.4|5.33||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement level: Dysport® 800 U versus Placebo||5.33|1.40|0.0034
73931806|NCT02660359|147393657|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|7.38|||<|0.0001|TWO_SIDED|95.0|3.5|15.58||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement level: Dysport® 600 U versus Placebo||15.58|3.5|<0.0001
74029915|NCT02433210|147614099|SUPERIORITY||||||=|0.815|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Revaclear vs ELISIO.||||=0.815
74029916|NCT02433210|147614099|SUPERIORITY||||||=|0.367|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of Phosphate Optiflux vs Revaclear.||||=0.367
74029917|NCT02433210|147614099|SUPERIORITY||||||=|0.821|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of phosphate Optiflux vs Elisio.||||=0.821
74088609|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.06|||||TWO_SIDED|90.0|-3.22|1.1|||Mixed Models Analysis|||6 hours postdose||1.10|-3.22|
74088610|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.73|||||TWO_SIDED|90.0|-4.88|-0.57|||Mixed Models Analysis|||8 hours postdose||-0.57|-4.88|
73931807|NCT02660359|147393657|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|5.28|||<|0.0001|TWO_SIDED|95.0|2.48|11.24||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement level: Dysport® 800 U versus Placebo||11.24|2.48|<0.0001
73931808|NCT02660359|147393659|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|96.14|||<|0.0001|TWO_SIDED|95.0|53.1|139.19|||MMRM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||139.19|53.10|<0.0001
73931809|NCT02660359|147393659|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|90.78|||<|0.0001|TWO_SIDED|95.0|47.07|134.48|||MMRM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||134.48|47.07|<0.0001
73931810|NCT02660359|147393660|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|175.0|||<|0.0001|TWO_SIDED|95.0|122.9|227.0|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||227.0|122.90|<0.0001
73931811|NCT02660359|147393660|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|168.4|||<|0.0001|TWO_SIDED|95.0|113.6|223.1|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||223.1|113.6|<0.0001
73931812|NCT02660359|147393661|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-41.5|-24.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-24.4|-41.5|<0.0001
73931813|NCT02660359|147393661|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|-32.5|||<|0.0001|TWO_SIDED|95.0|-41.5|-23.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-23.4|-41.5|<0.0001
73931814|NCT02660359|147393662|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|152.8|||<|0.0001|TWO_SIDED|95.0|99.2|206.5|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||206.5|99.2|<0.0001
73931815|NCT02660359|147393662|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|169.7|||<|0.0001|TWO_SIDED|95.0|111.7|227.6|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||227.6|111.7|<0.0001
73931816|NCT02660359|147393663|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|Odds Ratio (OR)|31.1|||<|0.0001|TWO_SIDED|95.0|7.05|137.09|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||137.09|7.05|<0.0001
73931817|NCT02660359|147393663|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|Odds Ratio (OR)|28.08|||<|0.0001|TWO_SIDED|95.0|6.24|126.25|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by- visit interaction and study baseline weekly number of UI episodes as fixed effect.||126.25|6.24|<0.0001
73931818|NCT04086472|147393669|SUPERIORITY||Least squares (LS) Mean Difference|-1.31||||0.808|TWO_SIDED|90.0|-10.25|7.64|||ANOVA|||Treatment vs. Placebo||7.64|-10.25|0.808
73931819|NCT04086472|147393669|SUPERIORITY||LS Mean Difference|-6.51||||0.229|TWO_SIDED|90.0|-15.46|2.43|||ANOVA|||Treatment vs. Placebo||2.43|-15.46|0.229
73931820|NCT04086472|147393669|SUPERIORITY||LS Mean Difference|-4.81||||0.363|TWO_SIDED|90.0|-13.58|3.96|||ANOVA|||Treatment vs. Placebo||3.96|-13.58|0.363
73931821|NCT04086472|147393669|SUPERIORITY||LS Mean Difference|-5.92||||0.273|TWO_SIDED|90.0|-14.87|3.02|||ANOVA|||Treatment vs. Placebo||3.02|-14.87|0.273
73931822|NCT04086472|147393670|OTHER|Treatment vs. Placebo|Difference in percentage|0.51|||||TWO_SIDED|95.0|-36.57|37.78|||||95% CI based on the Chan and Zhang exact method|||37.78|-36.57|
73931823|NCT04086472|147393670|OTHER|Treatment vs. Placebo|Difference in percentage|-22.56|||||TWO_SIDED|95.0|-56.7|15.53|||||95% CI based on the Chan and Zhang exact method|||15.53|-56.70|
73931824|NCT04086472|147393670|OTHER|Treatment vs. Placebo|Difference in percentage|-17.62|||||TWO_SIDED|95.0|-53.09|20.01|||||95% CI based on the Chan and Zhang exact method|||20.01|-53.09|
73931825|NCT04086472|147393670|OTHER|Treatment vs. Placebo|Difference in percentage|-22.56|||||TWO_SIDED|95.0|-56.7|15.53|||||95% CI based on the Chan and Zhang exact method|Treatment vs. Placebo||15.53|-56.70|
74088611|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.05|||||TWO_SIDED|90.0|-3.77|-0.32|||Mixed Models Analysis|||12 hours postdose||-0.32|-3.77|
74088612|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.21|||||TWO_SIDED|90.0|-1.9|2.33|||Mixed Models Analysis|||24 hours postdose||2.33|-1.90|
73931826|NCT00048724|147393693|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.452||||0.1439||95.0|0.88|2.396|||Cox Proportional Hazards Model|Age (\<= 50 years, \>50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The primary scientific hypothesis is that, 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of clinical events in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.||2.396|0.880|0.1439
73931827|NCT00048724|147393694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.007||95.0|1.13|2.166|||Cox Proportional Hazards Model|Age (\<= 50 years, \>50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The secondary hypothesis is that 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of disease progression in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.||2.166|1.130|0.0070
73931828|NCT00844545|147393695|SUPERIORITY_OR_OTHER||LS mean change from baseline|65.18|||<|0.0001|TWO_SIDED|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols: C08-002A (adult) and C08-002B (adolescent), a similar protocol, for patients \<18 years with aHUS.||93.36|37.01|<0.0001
73931829|NCT00844545|147393696|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|82.0|||||TWO_SIDED|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||96|57|
73931830|NCT00844545|147393697|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
73931831|NCT00844545|147393698|SUPERIORITY_OR_OTHER||Percent of complete TMA response|65.0|||||TWO_SIDED|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||86|38|
74008180|NCT03627767|147566484|SUPERIORITY||Difference in percentage|17.5|||||TWO_SIDED|95.0|9.6|25.5||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|9.6|
74029918|NCT02433210|147614099|SUPERIORITY||||||=|0.364|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance phosphate Revaclear vs ELISIO.||||=0.364
74029919|NCT02433210|147614099|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of beta 2 microglobulin Optiflux vs Revaclear.||||<0.001
74029920|NCT02433210|147614099|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of beta 2 microglobulin Optiflux vs ELISIO.||||<0.001
74029921|NCT02433210|147614099|SUPERIORITY||||||=|0.254|||||||t-test, 2 sided|||Session 2 Clearance of beta 2 microglobulin Revaclear vs ELISIO.||||=0.254
74029922|NCT02433210|147614099|SUPERIORITY||||||=|0.079|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of myoglobin Optiflux vs Revaclear.||||=0.079
74029923|NCT02433210|147614099|SUPERIORITY||||||=|0.086|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of myoglobin Optiflux vs ELISIO.||||=0.086
74029924|NCT02433210|147614099|SUPERIORITY||||||=|0.888|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance myoglobin Revaclear vs ELISIO.||||=0.888
74029925|NCT02433210|147614099|SUPERIORITY||||||=|0.663||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Optiflux vs Revaclear.||||=0.663
74029926|NCT02433210|147614099|SUPERIORITY||||||=|0.391|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Optiflux vs ELISIO.||||=0.391
74029927|NCT02433210|147614099|SUPERIORITY||||||=|0.214|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Revaclear vs ELISIO.||||=0.214
74029928|NCT02433210|147614099|SUPERIORITY||||||=|0.918|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Optiflux vs Revaclear.||||=0.918
73931832|NCT00844545|147393699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
73931833|NCT00844545|147393700|SUPERIORITY_OR_OTHER||LS mean change from baseline|111.62|||<|0.0001|TWO_SIDED|95.0|98.12|125.13|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||125.13|98.12|<0.0001
73931834|NCT00844545|147393701|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
73931835|NCT00844545|147393702|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
73931836|NCT00844545|147393703|SUPERIORITY_OR_OTHER||Percent of complete TMA response|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
73931837|NCT00844545|147393704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
73931838|NCT02595684|147393724|SUPERIORITY|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
73931839|NCT02595684|147393724|SUPERIORITY|||||||0.635|||||||Wilcoxon (Mann-Whitney)|||||||0.635
73931840|NCT02595684|147393725|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.380
73931841|NCT02595684|147393725|SUPERIORITY|||||||0.441|||||||Wilcoxon (Mann-Whitney)|||||||0.441
73931842|NCT02595684|147393726|SUPERIORITY|||||||515|||||||Wilcoxon (Mann-Whitney)|||||||0515
73931843|NCT02595684|147393726|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
73931844|NCT02595684|147393727|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
74008181|NCT03627767|147566484|SUPERIORITY||Difference in percentage|35.3|||<|0.0001|TWO_SIDED|95.0|27.8|42.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||42.8|27.8|< 0.0001
74008182|NCT03627767|147566484|OTHER||Difference in percentage|55.3|||<|0.0001|TWO_SIDED|95.0|48.3|62.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||62.4|48.3|< 0.0001
73931845|NCT02595684|147393727|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
73931846|NCT02595684|147393728|SUPERIORITY|||||||0.767|||||||Wilcoxon (Mann-Whitney)|||||||0.767
73931847|NCT02595684|147393728|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||||||0.779
73931848|NCT02595684|147393729|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
73931849|NCT02595684|147393729|SUPERIORITY|||||||0.767|||||||Wilcoxon (Mann-Whitney)|||||||0.767
73931850|NCT02595684|147393730|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
73931851|NCT02595684|147393730|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
74029929|NCT02433210|147614099|SUPERIORITY||||||=|0.394|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Optiflux vs ELISIO.||||=0.394
73931852|NCT02595684|147393731|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
73931853|NCT02595684|147393731|SUPERIORITY|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
73931854|NCT02595684|147393732|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
73931855|NCT02595684|147393732|SUPERIORITY|||||||0.086|||||||Wilcoxon (Mann-Whitney)|||||||0.086
73931856|NCT02595684|147393733|SUPERIORITY|||||||0.285|||||||Wilcoxon (Mann-Whitney)|||||||0.285
73931857|NCT02595684|147393733|SUPERIORITY|||||||0.854|||||||Wilcoxon (Mann-Whitney)|||||||0.854
73931858|NCT02595684|147393734|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
73931859|NCT02595684|147393734|SUPERIORITY|||||||0.263|||||||Wilcoxon (Mann-Whitney)|||||||0.263
73931860|NCT02595684|147393735|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
73931861|NCT02595684|147393735|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
73931862|NCT02595684|147393736|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||||||0.722
73931863|NCT02595684|147393736|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
73931864|NCT02595684|147393737|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.260
73931865|NCT02595684|147393737|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
73931866|NCT02595684|147393738|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
73931867|NCT02595684|147393738|SUPERIORITY|||||||0.952|||||||Wilcoxon (Mann-Whitney)|||||||0.952
73931868|NCT02595684|147393739|SUPERIORITY|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
73931869|NCT02595684|147393739|SUPERIORITY|||||||0.108|||||||Wilcoxon (Mann-Whitney)|||||||0.108
74029930|NCT02433210|147614099|SUPERIORITY||||||=|0.211|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Revaclear vs ELISIO.||||=0.211
73863536|NCT04736628|147273280|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0102|||||||MCP-Mod quadratic model fit|Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0102
73863537|NCT04736628|147273280|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.023|||||||MCP-Mod linear model fit|Model assumption: no assumption is needed.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0230
73931870|NCT02595684|147393740|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||||||0.092
73931871|NCT02595684|147393740|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
73931872|NCT04394351|147393759|SUPERIORITY||Odds Ratio (OR)|53.8|||<|0.0001|TWO_SIDED|95.0|7.37|392.82|||Cochran-Mantel-Haenszel|p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline weight group.|Odds ratio and corresponding Confidence Interval (CI) are based on CMH test stratified by baseline weight group.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||392.82|7.37|<0.0001
73931873|NCT04394351|147393759|SUPERIORITY||Odds Ratio (OR)|46.7|||<|0.0001|TWO_SIDED|95.0|5.47|399.54|||Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group.|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||399.54|5.47|<0.0001
73931874|NCT04394351|147393760|SUPERIORITY||Odds Ratio (OR)|178.0|||<|0.0001|TWO_SIDED|95.0|18.84|1682.4|||Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||1682.4|18.84|<0.0001
74029931|NCT02433210|147614099|SUPERIORITY||||||=|0.222|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of phosphate Optiflux vs ELISIO.||||=0.222
74029932|NCT02433210|147614099|SUPERIORITY||||||=|0.162|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of phosphate Revaclear vs ELISIO.||||=0.162
74029933|NCT02433210|147614099|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of beta 2 microglobulin Optiflux vs Revaclear.||||<0.001
74029934|NCT02433210|147614099|SUPERIORITY||||||=|0.025||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of beta 2 microglobulin Optiflux vs ELISIO.||||=0.025
74029935|NCT02433210|147614099|SUPERIORITY||||||=|0.903|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of beta 2 microglobulin Revaclear vs ELISIO.||||=0.903
74029936|NCT02433210|147614099|SUPERIORITY||||||=|0.003||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of myoglobin Optiflux vs Revaclear.||||=0.003
74029937|NCT02433210|147614099|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of myoglobin Optiflux vs ELISIO.||||<0.001
74029938|NCT02433210|147614099|SUPERIORITY||||||=|0.472|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of myoglobin Revaclear vs ELISIO.||||=0.472
74029939|NCT02433210|147614100|SUPERIORITY||||||=|0.216||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.216
74029940|NCT02433210|147614100|SUPERIORITY|No significant difference|||||=|0.216||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.216
74029941|NCT02433210|147614100|SUPERIORITY|No significant difference|||||=|0.952||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.952
74029942|NCT02433210|147614100|SUPERIORITY|No Significant difference|||||=|0.714||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.714
73931875|NCT04394351|147393760|SUPERIORITY||Odds Ratio (OR)|55.3|||<|0.0001|TWO_SIDED|95.0|7.45|410.23||P-value is not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||410.23|7.45|<0.0001
73931876|NCT04394351|147393761|SUPERIORITY||LS mean difference|-107.07|||<|0.0001|TWO_SIDED|95.0|-139.249|-74.9|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-74.900|-139.249|<0.0001
73931877|NCT04394351|147393761|SUPERIORITY||LS mean difference|-98.92|||<|0.0001|TWO_SIDED|95.0|-132.463|-65.37||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-65.370|-132.463|<0.0001
73931878|NCT04394351|147393762|SUPERIORITY||LS mean difference|-0.902|||<|0.0001|TWO_SIDED|95.0|-1.0325|-0.7714|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-0.7714|-1.0325|<0.0001
73931879|NCT04394351|147393762|SUPERIORITY||LS mean difference|-0.78|||<|0.0001|TWO_SIDED|95.0|-0.917|-0.644||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-0.6440|-0.9170|<0.0001
73931880|NCT04394351|147393763|SUPERIORITY||LS mean difference|-0.883|||<|0.0001|TWO_SIDED|95.0|-1.0095|-0.7568|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-0.7568|-1.0095|<0.0001
73931881|NCT04394351|147393763|SUPERIORITY||LS mean difference|-0.769|||<|0.0001|TWO_SIDED|95.0|-0.9013|-0.6362||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-0.6362|-0.9013|<0.0001
73931882|NCT04394351|147393764|SUPERIORITY||Hodges-Lehmann estimator|-2.22|||<|0.0001|TWO_SIDED|95.0|-2.44|-1.95|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-1.9500|-2.4400|<0.0001
73931883|NCT04394351|147393764|SUPERIORITY||Hodges-Lehmann estimator|-2.19|||<|0.0001|TWO_SIDED|95.0|-2.45|-1.82||P-value is not adjusted for multiple comparisons|Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-1.8200|-2.4500|<0.0001
73931884|NCT04394351|147393765|SUPERIORITY||Hodges-Lehmann estimator|-2.84|||<|0.0001|TWO_SIDED|95.0|-3.35|-1.96|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-1.9600|-3.3500|<0.0001
73931885|NCT04394351|147393765|SUPERIORITY||Hodges-Lehmann estimator|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.31|-1.62||P-value is not adjusted for multiple comparisons|Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-1.6200|-3.3100|<0.0001
73931886|NCT04394351|147393766|SUPERIORITY||LS mean difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.94|-2.63|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-2.63|-4.94|<0.0001
73931887|NCT04394351|147393766|SUPERIORITY||LS mean difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.59|-2.1||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-2.10|-4.59|<0.0001
73931888|NCT04394351|147393767|SUPERIORITY||LS mean difference|-0.1||||0.1526|TWO_SIDED|95.0|-0.244|0.038|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.038|-0.244|0.1526
73931889|NCT04394351|147393767|SUPERIORITY||LS mean difference|0.0||||0.9533|TWO_SIDED|95.0|-0.155|0.146||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.146|-0.155|0.9533
73931890|NCT04394351|147393768|SUPERIORITY||LS mean difference|1.45||||0.1507|TWO_SIDED|95.0|-0.527|3.422||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||3.422|-0.527|0.1507
73931891|NCT04394351|147393768|SUPERIORITY||LS mean difference|0.0||||0.9965|TWO_SIDED|95.0|-2.107|2.117||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||2.117|-2.107|0.9965
73931892|NCT04394351|147393769|SUPERIORITY||LS mean difference|-0.05||||0.2064|TWO_SIDED|95.0|-0.139|0.03||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.030|-0.139|0.2064
73863538|NCT04736628|147273280|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0292|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0292
73863539|NCT04736628|147273280|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0468|||||||MCP-Mod Exponential model fit|Model assumption: 20% of the maximum effect is achieved at 3 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0468
73863540|NCT04736628|147273281|OTHER||Mean Difference (Net)|-0.217||||0.0327|TWO_SIDED|95.0|-0.416|-0.018|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 1 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.018|-0.416|0.0327
73863541|NCT04736628|147273281|OTHER||Mean Difference (Net)|-0.206||||0.0447|TWO_SIDED|95.0|-0.408|-0.005|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 2 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.005|-0.408|0.0447
73863542|NCT04736628|147273281|OTHER||Mean Difference (Net)|-0.187||||0.0654|TWO_SIDED|95.0|-0.387|0.012|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 3 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||0.012|-0.387|0.0654
73863543|NCT04736628|147273282|OTHER||Odds Ratio (OR)|2.2||||0.0476|TWO_SIDED|95.0|1.01|4.79||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 1 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.79|1.01|0.0476
73863544|NCT04736628|147273282|OTHER||Odds Ratio (OR)|2.72||||0.0119|TWO_SIDED|95.0|1.25|5.94||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 2 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||5.94|1.25|0.0119
73863545|NCT04736628|147273282|OTHER||Odds Ratio (OR)|3.43||||0.0019|TWO_SIDED|95.0|1.58|7.45||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 3 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||7.45|1.58|0.0019
73931893|NCT04394351|147393769|SUPERIORITY||LS mean difference|0.02||||0.6361|TWO_SIDED|95.0|-0.069|0.112||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.112|-0.069|0.6361
73931894|NCT04394351|147393770|SUPERIORITY||LS mean difference|0.13||||0.2086|TWO_SIDED|95.0|-0.072|0.33||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.330|-0.072|0.2086
74008183|NCT03627767|147566484|SUPERIORITY||Difference in percentage|20.3|||||TWO_SIDED|95.0|12.1|28.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||28.5|12.1|
74029943|NCT02433210|147614100|SUPERIORITY||||||=|0.156||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.156
73863546|NCT04736628|147273283|OTHER||Odds Ratio (OR)|2.13||||0.0497|TWO_SIDED|95.0|1.0|4.55||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 1 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.55|1.00|0.0497
73863547|NCT04736628|147273283|OTHER||Odds Ratio (OR)|2.15||||0.0502|TWO_SIDED|95.0|1.0|4.61||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 2 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.61|1.00|0.0502
73863548|NCT04736628|147273283|OTHER||Odds Ratio (OR)|2.09||||0.0572|TWO_SIDED|95.0|0.98|4.49||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 3 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.49|0.98|0.0572
73931895|NCT04394351|147393770|SUPERIORITY||LS mean difference|0.1||||0.2975|TWO_SIDED|95.0|-0.088|0.286||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.286|-0.088|0.2975
73931896|NCT04394351|147393771|SUPERIORITY||LS mean difference|-1.8||||0.2085|TWO_SIDED|95.0|-4.615|1.007||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||1.007|-4.615|0.2085
73931897|NCT04394351|147393771|SUPERIORITY||LS mean difference|-1.36||||0.3098|TWO_SIDED|95.0|-3.972|1.26||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||1.260|-3.972|0.3098
74008184|NCT03627767|147566485|SUPERIORITY||Difference in percentage|0.7|||=|0.1848|TWO_SIDED|95.0|-0.3|1.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.7|-0.3|= 0.1848
74029944|NCT02433210|147614100|SUPERIORITY||||||=|0.427||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.427
74029945|NCT02433210|147614100|SUPERIORITY||||||=|0.487||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.487
74029946|NCT02433210|147614100|SUPERIORITY|Failed normality test|||||=|0.111||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|The difference in the median values between the two groups is not \> enough to exclude that the difference is due to random sampling variability||No significant difference||||=0.111
74029947|NCT02433210|147614100|SUPERIORITY|Failed normality test|||||=|0.198||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.198
74029948|NCT02433210|147614100|SUPERIORITY||||||=|0.007||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Showed a significant difference||||=0.007
74029949|NCT02433210|147614100|SUPERIORITY||||||=|0.202||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.202
74029950|NCT02433210|147614100|SUPERIORITY||||||=|0.54||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.540
74029951|NCT02433210|147614101|SUPERIORITY||||||=|0.204|||||||Wilcoxon (Mann-Whitney)|||||||=0.204
74029952|NCT02433210|147614101|SUPERIORITY||||||=|0.234|||||||Wilcoxon (Mann-Whitney)|||||||=0.234
74029953|NCT02433210|147614101|SUPERIORITY||||||=|0.015||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the \<0.050 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either then the non-parametric Mann-Whitney Rank Sum Test was used.||||||=0.015
74029954|NCT02433210|147614101|SUPERIORITY||||||=|0.413||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.413
74029955|NCT02433210|147614101|SUPERIORITY||||||=|0.314||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.314
74029956|NCT02433210|147614101|SUPERIORITY||||||=|0.769||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.769
74029957|NCT02433210|147614102|SUPERIORITY||||||=|0.376|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.376
74029958|NCT02433210|147614102|SUPERIORITY|||||||1||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||1.000
74029959|NCT02433210|147614102|SUPERIORITY|||||||0.713|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||0.713
74088613|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.83|||||TWO_SIDED|90.0|-5.56|-2.11|||Mixed Models Analysis|||30 minutes postdose||-2.11|-5.56|
74088614|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.75|||||TWO_SIDED|90.0|-2.75|1.25|||Mixed Models Analysis|||1 hour postdose||1.25|-2.75|
74088615|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.45|||||TWO_SIDED|90.0|-1.49|2.38|||Mixed Models Analysis|||1.5 hours postdose||2.38|-1.49|
74088616|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.58|||||TWO_SIDED|90.0|0.58|4.58|||Mixed Models Analysis|||2 hours postdose||4.58|0.58|
74088617|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.85|||||TWO_SIDED|90.0|0.73|4.98|||Mixed Models Analysis|||2.5 hours postdose||4.98|0.73|
74088618|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.94|||||TWO_SIDED|90.0|1.85|6.03|||Mixed Models Analysis|||3 hours postdose||6.03|1.85|
74088619|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.28|||||TWO_SIDED|90.0|3.61|6.95|||Mixed Models Analysis|||3.5 hours postdose||6.95|3.61|
74088620|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|6.94|||||TWO_SIDED|90.0|4.99|8.89|||Mixed Models Analysis|||4 hours postdose||8.89|4.99|
74088621|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.13|||||TWO_SIDED|90.0|0.93|5.34|||Mixed Models Analysis|||6 hours postdose||5.34|0.93|
74088622|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.09|||||TWO_SIDED|90.0|-0.23|4.4|||Mixed Models Analysis|||8 hours postdose||4.40|-0.23|
74088623|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.37|||||TWO_SIDED|90.0|-0.57|3.3|||Mixed Models Analysis|||12 hours postdose||3.30|-0.57|
74088624|NCT03465436|147730585|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.29|||||TWO_SIDED|90.0|-2.21|1.63|||Mixed Models Analysis|||24 hours postdose||1.63|-2.21|
74088625|NCT03465436|147730585|SUPERIORITY||LS Mean|7.32|||||TWO_SIDED|90.0|5.03|9.6|||Mixed Models Analysis|||30 minutes postdose||9.60|5.03|
74088626|NCT03465436|147730585|SUPERIORITY||LS Mean|12.28|||||TWO_SIDED|90.0|10.47|14.1|||Mixed Models Analysis|||1 hour postdose||14.10|10.47|
74088627|NCT03465436|147730585|SUPERIORITY||LS Mean|11.27|||||TWO_SIDED|90.0|9.54|13.0|||Mixed Models Analysis|||1.5 hours postdose||13.00|9.54|
74088628|NCT03465436|147730585|SUPERIORITY||LS Mean|11.92|||||TWO_SIDED|90.0|9.97|13.87|||Mixed Models Analysis|||2 hours postdose||13.87|9.97|
74088629|NCT03465436|147730585|SUPERIORITY||LS Mean|10.98|||||TWO_SIDED|90.0|9.17|12.79|||Mixed Models Analysis|||2.5 hours postdose||12.79|9.17|
74088630|NCT03465436|147730585|SUPERIORITY||LS Mean|11.99|||||TWO_SIDED|90.0|10.1|13.87|||Mixed Models Analysis|||3 hours postdose||13.87|10.10|
74088631|NCT03465436|147730585|SUPERIORITY||LS Mean|12.19|||||TWO_SIDED|90.0|10.32|14.05|||Mixed Models Analysis|||3.5 hours postdose||14.05|10.32|
74088632|NCT03465436|147730585|SUPERIORITY||LS Mean|11.68|||||TWO_SIDED|90.0|9.83|13.52|||Mixed Models Analysis|||4 hours postdose||13.52|9.83|
74088633|NCT03465436|147730585|SUPERIORITY||LS Mean|8.24|||||TWO_SIDED|90.0|6.1|10.39|||Mixed Models Analysis|||6 hours postdose||10.39|6.10|
74088634|NCT03465436|147730585|SUPERIORITY||LS Mean|7.87|||||TWO_SIDED|90.0|5.66|10.07|||Mixed Models Analysis|||8 hours postdose||10.07|5.66|
74088635|NCT03465436|147730585|SUPERIORITY||LS Mean|6.35|||||TWO_SIDED|90.0|4.32|8.38|||Mixed Models Analysis|||12 hours postdose||8.38|4.32|
74088636|NCT03465436|147730585|SUPERIORITY||LS Mean|6.13|||||TWO_SIDED|90.0|3.88|8.38|||Mixed Models Analysis|||24 hours postdose||8.38|3.88|
74088637|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.49|||||TWO_SIDED|90.0|-6.47|-2.52|||Mixed Models Analysis|||30 minutes postdose||-2.52|-6.47|
74088638|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.3|||||TWO_SIDED|90.0|-7.18|-3.42|||Mixed Models Analysis|||1 hour postdose||-3.42|-7.18|
74088639|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.7|||||TWO_SIDED|90.0|-7.57|-3.82|||Mixed Models Analysis|||1.5 hours postdose||-3.82|-7.57|
74088640|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.47|||||TWO_SIDED|90.0|-6.64|-2.3|||Mixed Models Analysis|||2 hours postdose||-2.30|-6.64|
74088641|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.53|||||TWO_SIDED|90.0|-6.87|-2.19|||Mixed Models Analysis|||2.5 hours postdose||-2.19|-6.87|
74088642|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.74|||||TWO_SIDED|90.0|-4.9|-0.59|||Mixed Models Analysis|||3 hours postdose||-0.59|-4.90|
74088643|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.74|||||TWO_SIDED|90.0|-3.86|0.39|||Mixed Models Analysis|||3.5 hours postdose||0.39|-3.86|
74088644|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.66|||||TWO_SIDED|90.0|-3.77|0.44|||Mixed Models Analysis|||4 hours postdose||0.44|-3.77|
73931898|NCT04394351|147393772|SUPERIORITY||LS mean difference|0.07||||0.236|TWO_SIDED|95.0|-0.046|0.186||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.186|-0.046|0.2360
73931899|NCT04394351|147393772|SUPERIORITY||LS mean difference|0.07||||0.1939|TWO_SIDED|95.0|-0.037|0.181||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.181|-0.037|0.1939
73931900|NCT02732847|147393832|OTHER|Chi square tests used to compared groups||||||0.924||||||A p-value of \< 0.05 was considered|Chi-squared|||||||0.924
73931901|NCT02357576|147393868|OTHER|Percentage and frequencies were used to describe the incidence of PNAC in the two groups.||||||0.617|||||||Fisher Exact|||||||0.617
73931902|NCT02357576|147393869|OTHER|Percentage and frequencies were used to describe the incidence of severe PNAC.||||||0.45|||||||Fisher Exact|||||||0.450
73931903|NCT02357576|147393870|OTHER|The Kaplan Meier curve was used to evaluated the time to first PNAC event.||||||0.2716|||||||Log Rank|A log rank test was used to test the equality of the survival curve between the two groups.||||||0.2716
73931904|NCT00128180|147393887|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
73931905|NCT03296163|147393901|EQUIVALENCE|"Equivalence analysis was based on the risk ratio (RR) (MB02/EU-approved Avastin) with an equivalence margin predefined \[0.73, 1.36\].~The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the RR and corresponding 2-sided 90% confidence interval (CI)."|Risk Ratio (RR)|0.91|||||TWO_SIDED|90.0|0.78|1.06|||||Direction of comparison is: For RR: MB02/EU-approved Avastin. 95% CI was also calculated: (0.758, 1.092)|||1.060|0.780|
73931906|NCT03296163|147393901|EQUIVALENCE|The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the risk difference (RD) (MB02-EU-approved Avastin) with an equivalence margin predefined \[-12%, 12%\] and corresponding 2-sided 95% CI.|Risk Difference (RD)|-4.02|||||TWO_SIDED|90.0|-10.51|2.47|||||Direction of comparison is: For RD: MB02 - EU-approved Avastin. 95% CI was also calculated: (-11.76, 3.71)|||2.47|-10.51|
73931907|NCT03296163|147393902|OTHER|Hazard ratio of MB02 versus EU-approved Avastin; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in MB02; \<1 indicated an increase in PD/death in EU-approved Avastin.|Hazard Ratio (HR)|1.187|||||TWO_SIDED|95.0|0.98|1.44||||||||1.44|0.98|
73931908|NCT03296163|147393903|OTHER||Hazard Ratio (HR)|1.108|||||TWO_SIDED|95.0|0.827|1.485||||||||1.485|0.827|
73931909|NCT03495908|147393913|NON_INFERIORITY|Non-inferiority margin is 0.4% HbA1c|Mean Difference (Net)|-0.2207||||0.007|TWO_SIDED|95.0|-0.6654|0.2241||Non-inferiority p-value based on the 0.4% non-inferiority margin|Mixed Models Analysis||RHI - RAI estimated treatment difference. Upper confidence interval 0.22 is less than the 0.4% non-inferiority margin.|RHI - RAI estimated treatment difference (ETD) in HbA1c. Per-protocol analysis is the pre-specified primary outcome.||0.2241|-0.6654|0.007
73931910|NCT03495908|147393914|SUPERIORITY|Comparison of Post-randomization prevalence of hypoglycemia based on 7-point glucose profiles.||||||0.82|||||||Fisher Exact|||Post-randomization prevalence of hypoglycemia based on 7-point glucose profiles.||||.82
73931911|NCT03495908|147393915|SUPERIORITY|Analysis of the 7-point profiles within the ITT population (n=136)|Risk Ratio (RR)|0.925||||0.861|TWO_SIDED|95.0|0.386|2.217||Results are from a Poisson regression model with repeated measures; generalized estimating equations (GEE) approach.|Regression, Poisson|Poisson regression model with repeated measures; generalized estimating equations (GEE) approach|The incidence rate ratio quantitates the risk of hypoglycemia in the RHI group (RR numerator) compared with the RAI group (RR numerator). Results from Poisson regression model with repeated measures; generalized estimating equations (GEE) approach.|Level 1 (≤70 mg/dL or (\<3.9 mmol/L)) and level 2 hypoglycemia (\<54 mg/dL (\<3.0 mmol/L)) events are analyzed. No level 3 events were reported for either group.||2.217|0.386|0.861
73931912|NCT03495908|147393916|SUPERIORITY||Mean Difference (Net)|-0.01073||||0.415|TWO_SIDED|95.0|-0.03674|0.01528|||Mixed Models Analysis||Between Group Comparison (RHI-RAI) Estimated Treatment Difference (ETD) mixed effects model analysis|RHI versus RAI for Insulin Intent-to-treat Population N=136 Mixed Model Estimates for Insulin TDD U/kg I||0.01528|-0.03674|0.415
73931913|NCT03495908|147393917|SUPERIORITY||Mean Difference (Net)|-1.0776||||0.32|TWO_SIDED|95.0|-3.2139|1.0587|||Mixed Models Analysis||Between Group Comparison (RHI-RAI) Estimated Treatment Difference (ETD) mixed effects model analysis|||1.0587|-3.2139|0.320
73931914|NCT03495908|147393918|SUPERIORITY||Mean Difference (Net)|-265.85|||<|0.0001|TWO_SIDED|95.0|-288.6|-243.11|||Mixed Models Analysis||Estimated Treatment Difference (RHI-RAI) from repeated measures mixed model least squares estimates|||-243.11|-288.60|<0.0001
73931915|NCT03495908|147393919|NON_INFERIORITY|Change in A1C Non-inferiority Margin is 0.4%|Mean Difference (Net)|-0.1317||||0.02|TWO_SIDED|95.0|-0.5838|0.3205||p-value for non-inferiority|Mixed Models Analysis||Between Group Difference (RHI-RAI) mixed effects repeated measures model analysis.Upper confidence interval 0.32 is less than the 0.4% non-inferiority margin.|Intent-to-treat secondary outcome of HbA1c response for assessment of non-inferiority of RHI compared to RAI||0.3205|-0.5838|0.02
73931916|NCT02553746|147394028|SUPERIORITY|||||||0.748|||||||Chi-squared, Corrected|||||||0.748
73931917|NCT02553746|147394029|SUPERIORITY|||||||0.498|||||||Chi-squared, Corrected|||||||0.498
73931918|NCT02553746|147394030|SUPERIORITY|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
73931919|NCT02553746|147394031|SUPERIORITY|||||||0.162|||||||Wilcoxon (Mann-Whitney)|||||||0.162
73931920|NCT02553746|147394032|SUPERIORITY|||||||0.104|||||||Chi-squared, Corrected|||||||0.104
73931921|NCT02553746|147394033|SUPERIORITY||||||<|0.005|||||||Wilcoxon (Mann-Whitney)|||||||<0.005
73931922|NCT02517905|147394040|SUPERIORITY||LSMD|-2.7||||0.8661|TWO_SIDED|95.0|-33.5|28.2|||ANOVA|||||28.2|-33.5|0.8661
73931923|NCT02517905|147394041|SUPERIORITY||LSMD|-4.0||||0.578|TWO_SIDED|95.0|-18.2|10.2|||ANOVA|||||10.2|-18.2|0.5780
74029960|NCT02433210|147614102|SUPERIORITY||||||=|0.424|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.424
74029961|NCT02433210|147614102|SUPERIORITY||||||=|0.23|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.230
73931924|NCT02517905|147394042|SUPERIORITY||LSMD|5.9||||0.801|TWO_SIDED|95.0|-40.2|52.1|||ANOVA|||||52.1|-40.2|0.8010
73931925|NCT02556710|147394049|SUPERIORITY|||||||0.94|||||||ANCOVA|Adjusted for baseline WOMAC Score||||||0.94
73931926|NCT02556710|147394050|SUPERIORITY|||||||0.53|||||||ANCOVA|Adjusted for baseline WOMAC score||||||0.53
73931927|NCT02556710|147394051|SUPERIORITY|||||||0.35||||||Adjusted for baseline WOMAC Score.|ANCOVA|||||||0.35
73931928|NCT01312909|147394052|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6337|TWO_SIDED|95.0|0.59|2.37||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.||2.37|0.59|0.6337
73931929|NCT01312909|147394052|SUPERIORITY||Odds Ratio (OR)|1.73||||0.1114|TWO_SIDED|95.0|0.88|3.39||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.||3.39|0.88|0.1114
73931930|NCT01312909|147394053|SUPERIORITY||Odds Ratio (OR)|1.21||||0.5793|TWO_SIDED|95.0|0.62|2.38|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12||2.38|0.62|0.5793
73931931|NCT01312909|147394053|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0932|TWO_SIDED|95.0|0.91|3.51|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12||3.51|0.91|0.0932
73931932|NCT01312909|147394053|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5647|TWO_SIDED|95.0|0.61|2.5|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24||2.50|0.61|0.5647
73931933|NCT01312909|147394053|SUPERIORITY||Odds Ratio (OR)|1.46||||0.2917|TWO_SIDED|95.0|0.72|2.96|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24||2.96|0.72|0.2917
73931934|NCT01312909|147394053|SUPERIORITY||Odds Ratio (OR)|1.25||||0.5616|TWO_SIDED|95.0|0.58|2.69|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52||2.69|0.58|0.5616
73931935|NCT01312909|147394053|SUPERIORITY||Odds Ratio (OR)|1.79||||0.13|TWO_SIDED|95.0|0.84|3.78|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52||3.78|0.84|0.1300
73931936|NCT01312909|147394055|SUPERIORITY||Least square (LS) mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.58||0.354|TWO_SIDED|95.0|-1.69|0.6|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.60|-1.69|0.3540
73931937|NCT01312909|147394055|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.59||0.7574|TWO_SIDED|95.0|-1.35|0.98|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.98|-1.35|0.7574
73931938|NCT01312909|147394055|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.6||0.5676|TWO_SIDED|95.0|-1.53|0.84|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.84|-1.53|0.5676
73931939|NCT01312909|147394055|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.61||0.2356|TWO_SIDED|95.0|-1.92|0.47|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.47|-1.92|0.2356
73931940|NCT01312909|147394055|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.62||0.773|TWO_SIDED|95.0|-1.03|1.38|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||1.38|-1.03|0.7730
73931941|NCT01312909|147394055|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.62||0.2166|TWO_SIDED|95.0|-1.99|0.45|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.45|-1.99|0.2166
73931942|NCT01312909|147394056|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6133|TWO_SIDED|95.0|0.34|1.9|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||1.90|0.34|0.6133
74029962|NCT02433210|147614102|SUPERIORITY||||||=|0.678|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.678
74029963|NCT02433210|147614102|SUPERIORITY||||||=|0.643|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.643
74029964|NCT02433210|147614102|SUPERIORITY||||||=|0.43|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.430
73971565|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.674||||0.6607|TWO_SIDED|95.0|-2.347|3.694|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.694|-2.347|0.6607
73971566|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.809||||0.1309|TWO_SIDED|95.0|-0.827|10.446|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||10.446|-0.827|0.1309
74088645|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.11|||||TWO_SIDED|90.0|-3.17|0.94|||Mixed Models Analysis|||6 hours postdose||0.94|-3.17|
73971567|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.553||||0.9776|TWO_SIDED|95.0|-4.212|7.318|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.318|-4.212|0.9776
73971568|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.862||||0.1422|TWO_SIDED|95.0|-0.939|10.663|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||10.663|-0.939|0.1422
73971569|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.851||||0.0334|TWO_SIDED|95.0|0.307|11.396|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||11.396|0.307|0.0334
74008185|NCT03627767|147566485|SUPERIORITY||Difference in percentage|0.3|||=|0.5971|TWO_SIDED|95.0|-0.9|1.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.6|-0.9|= 0.5971
74008186|NCT03627767|147566485|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-1.1|0.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.4|-1.1|
74088646|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.47|||||TWO_SIDED|90.0|-4.58|-0.35|||Mixed Models Analysis|||8 hours postdose||-0.35|-4.58|
74088647|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.15|||||TWO_SIDED|90.0|-3.87|-0.43|||Mixed Models Analysis|||12 hours postdose||-0.43|-3.87|
74088648|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.79|||||TWO_SIDED|90.0|-1.14|2.72|||Mixed Models Analysis|||24 hours postdose||2.72|-1.14|
73971570|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|3.08||||0.5622|TWO_SIDED|95.0|-2.501|8.66|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.660|-2.501|0.5622
73971571|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.014||||0.2841|TWO_SIDED|95.0|-1.643|9.672|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||9.672|-1.643|0.2841
73971572|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.438||||0.0178|TWO_SIDED|95.0|0.774|8.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.103|0.774|0.0178
73971573|NCT04800211|147483696|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.847||||0.6944|TWO_SIDED|95.0|-3.398|5.093|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.093|-3.398|0.6944
74008187|NCT03627767|147566485|SUPERIORITY||Difference in percentage|49.4|||<|0.0001|TWO_SIDED|95.0|42.0|56.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||56.8|42.0|< 0.0001
74008188|NCT03627767|147566485|SUPERIORITY||Difference in percentage|65.5|||<|0.0001|TWO_SIDED|95.0|59.3|71.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||71.7|59.3|< 0.0001
74008189|NCT03627767|147566485|SUPERIORITY||Difference in percentage|16.3|||||TWO_SIDED|95.0|10.3|22.3||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.3|10.3|
74008190|NCT03627767|147566485|SUPERIORITY||Difference in percentage|42.7|||<|0.0001|TWO_SIDED|95.0|35.2|50.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.2|35.2|< 0.0001
74008191|NCT03627767|147566485|SUPERIORITY||Difference in percentage|62.6|||<|0.0001|TWO_SIDED|95.0|56.0|69.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.2|56.0|< 0.0001
74008192|NCT03627767|147566485|SUPERIORITY||Difference in percentage|19.8|||||TWO_SIDED|95.0|12.3|27.4||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||27.4|12.3|
74029965|NCT02433210|147614102|SUPERIORITY||||||=|0.295|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.295
74029966|NCT02433210|147614102|SUPERIORITY||||||=|0.723|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.723
74029967|NCT02433210|147614102|SUPERIORITY||||||=|0.749|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.749
73863552|NCT04068610|147273320|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3173|TWO_SIDED|95.0|0.6|5.6|||Cochran-Mantel-Haenszel|P-value for comparison of treatment arms obtained from stratified Cochran-Mantel-Haenszel test stratified by the location of the primary tumor.||||5.6|0.6|0.3173
73863553|NCT03344172|147273354|SUPERIORITY||Odds Ratio (OR)|0.52||||0.63|TWO_SIDED|95.0|0.3|6.71|||Fisher Exact|||||6.71|0.30|0.63
73863554|NCT03344172|147273355|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_DEVIATION|0.52||0.13|TWO_SIDED|95.0|-1.0|-0.25|||t-test, 2 sided|||||-0.25|-1.00|0.13
73863555|NCT03973905|147273369|OTHER||Vaccine Effectiveness|65.26|||||TWO_SIDED|95.0|-64.93|92.68|||||Vaccine Effectiveness (VE) was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during third trimester of pregnancy (at least 14 days before delivery) at preventing pertussis in infants \<2 months||92.68|-64.93|
73863556|NCT03973905|147273370|OTHER||Vaccine Effectiveness|42.01|||||TWO_SIDED|95.0|-1071.8|97.13|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix before pregnancy at preventing pertussis in infants \<2 months||97.13|-1071.80|
73863557|NCT03973905|147273370|OTHER||Vaccine Effectiveness|62.17|||||TWO_SIDED|95.0|-439.75|97.35|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during first or second trimester of pregnancy at preventing pertussis in infants \<2 months||97.35|-439.75|
73931943|NCT01312909|147394056|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0335|TWO_SIDED|95.0|1.07|4.79|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||4.79|1.07|0.0335
74029968|NCT02433210|147614102|SUPERIORITY||||||=|0.967|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.967
74029969|NCT02433210|147614103|SUPERIORITY||||||=|0.67|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.670
74029970|NCT02433210|147614103|SUPERIORITY||||||=|0.993|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.993
74029971|NCT02433210|147614103|SUPERIORITY||||||=|0.65|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.650
73863558|NCT03973905|147273370|OTHER||Vaccine Effectiveness|-12.89|||||TWO_SIDED|95.0|-166.37|52.16|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix after pregnancy at preventing pertussis in infants \<2 months||52.16|-166.37|
73863559|NCT03973905|147273371|OTHER||Vaccine Effectiveness|64.79|||||TWO_SIDED|95.0|-57.51|92.13|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix at any time during pregnancy at preventing pertussis in infants \<2 months||92.13|-57.51|
73863560|NCT03973905|147273372|OTHER||Vaccine Effectiveness|17.65|||||TWO_SIDED|95.0|-12529.0|99.46|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix before pregnancy at preventing pertussis in infants \<2 months||99.46|-12529.0|
73863561|NCT03973905|147273372|OTHER||Vaccine Effectiveness|85.01|||||TWO_SIDED|95.0|-13.91|98.03|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during third trimester of pregnancy at preventing pertussis in infants \<2 months||98.03|-13.91|
73931944|NCT01312909|147394056|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9874|TWO_SIDED|95.0|0.37|2.65|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||2.65|0.37|0.9874
73931945|NCT01312909|147394056|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0188|TWO_SIDED|95.0|1.19|6.55|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||6.55|1.19|0.0188
73931946|NCT01602315|147394081|SUPERIORITY_OR_OTHER_LEGACY||median HR|0.99||||||||||||||The hazard ratio was estimated using the Bayesian Cox proportional hazard (PH) model.||||
73931947|NCT01602315|147394081|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12||||0.643|TWO_SIDED|95.0|0.69|1.82|||Regression, Cox|||||1.82|0.69|0.643
73931948|NCT01602315|147394081|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54||||0.039|TWO_SIDED|95.0|0.3|0.97|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from central data \[SLD (C)\], Hemaglobin (Hgb) and White Blood Cells (WBC).||0.97|0.30|0.039
73931949|NCT01602315|147394084|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier method (median)|43.0|||||TWO_SIDED|95.0|27.0|88.0|||||days|||88.0|27.0|
73931950|NCT01602315|147394090|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.28||||0.313|TWO_SIDED|95.0|0.79|2.05|||Regression, Cox|||||2.05|0.79|0.313
73931951|NCT01602315|147394091|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier (median)|294.0|||||TWO_SIDED|95.0|172.0|463.0||||||||463.0|172.0|
73931952|NCT01602315|147394105|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.235|TWO_SIDED|95.0|0.49|1.19|||Regression, Cox|||||1.19|0.49|0.235
73931953|NCT01602315|147394105|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.062|TWO_SIDED|95.0|0.4|1.02|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from local data \[SLD (L)\], Hemaglobin (Hgb) and White Blood Cells (WBC).||1.02|0.4|0.062
73931954|NCT01777997|147394146|OTHER|||||||0.001|||||||Regression, repeated measures (GEE)|||Estimated mean change from baseline to weeks 24-48 on ART from repeated measures (GEE) model, against the null hypothesis of zero change. Estimated mean represents on ART levels minus pre-ART levels.||||0.001
73931955|NCT00451282|147394156|SUPERIORITY_OR_OTHER|||||||0.69|||||||t-test, 2 sided|||||||.69
73931956|NCT00451282|147394157|SUPERIORITY_OR_OTHER|||||||0.89|||||||t-test, 2 sided|||||||.89
73931957|NCT00451282|147394158|SUPERIORITY_OR_OTHER|||||||0.69|||||||t-test, 2 sided|||||||.69
73931958|NCT00451282|147394159|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||.18
74029972|NCT02433210|147614103|SUPERIORITY||||||=|0.299|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.299
74029973|NCT02433210|147614103|SUPERIORITY||||||=|0.659|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.659
74029974|NCT02433210|147614103|SUPERIORITY||||||=|0.176|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.176
74029975|NCT02433210|147614103|SUPERIORITY||||||=|0.853|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.853
74029976|NCT02433210|147614103|SUPERIORITY||||||=|0.494|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.494
74029977|NCT02433210|147614103|SUPERIORITY||||||=|0.631|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.631
74029978|NCT02433210|147614103|SUPERIORITY||||||=|0.37|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.370
74029979|NCT02433210|147614103|SUPERIORITY||||||=|0.95|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.950
74029980|NCT02433210|147614103|SUPERIORITY||||||=|0.377|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.377
74029981|NCT02433210|147614104|SUPERIORITY||||||=|0.534|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.534
74029982|NCT02433210|147614104|SUPERIORITY||||||=|0.578|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.578
74029983|NCT02433210|147614104|SUPERIORITY||||||=|0.225|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.225
74029984|NCT02433210|147614104|SUPERIORITY||||||=|0.125|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.125
74029985|NCT02433210|147614104|SUPERIORITY||||||=|0.466|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.466
74029986|NCT02433210|147614104|SUPERIORITY||||||=|0.534|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.534
74029987|NCT02433210|147614104|SUPERIORITY||||||=|0.584|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.584
74029988|NCT02433210|147614104|SUPERIORITY||||||=|0.981|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.981
74029989|NCT02433210|147614104|SUPERIORITY||||||=|0.568|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.568
74029990|NCT02433210|147614104|SUPERIORITY||||||=|0.24|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.240
74029991|NCT02433210|147614104|SUPERIORITY||||||=|0.724|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.724
73931959|NCT01268644|147394170|SUPERIORITY|||||||0.14||||||P value comparing baseline to week 12|Mixed Models Analysis|||||||0.14
73931960|NCT01268644|147394171|SUPERIORITY|||||||0.01||||||P value comparing week 0 with week 12.|Mixed Models Analysis|||||||0.01
73931961|NCT01268644|147394172|SUPERIORITY|||||||0.009||||||P value comparing week 0 to week 12.|Mixed Models Analysis|||||||0.009
73931962|NCT01268644|147394173|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||||||0.75
73931963|NCT01416194|147394174|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
73931964|NCT01416194|147394174|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.91|TWO_SIDED|95.0|0.4|2.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.2|0.4|0.91
73931965|NCT01416194|147394175|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
73971574|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-35.556||||0.0031|TWO_SIDED|95.0|-59.038|-12.075|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-12.075|-59.038|0.0031
73971575|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-31.35||||0.0371|TWO_SIDED|95.0|-60.818|-1.882|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-1.882|-60.818|0.0371
73971576|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-34.356||||0.0043|TWO_SIDED|95.0|-57.877|-10.834|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-10.834|-57.877|0.0043
73971577|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-18.096||||0.2091|TWO_SIDED|95.0|-46.375|10.183|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||10.183|-46.375|0.2091
74008193|NCT03627767|147566485|SUPERIORITY||Difference in percentage|39.5|||<|0.0001|TWO_SIDED|95.0|32.1|46.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.9|32.1|< 0.0001
74008194|NCT03627767|147566485|SUPERIORITY||Difference in percentage|56.7|||<|0.0001|TWO_SIDED|95.0|49.8|63.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||63.7|49.8|< 0.0001
74008195|NCT03627767|147566485|SUPERIORITY||Difference in percentage|17.4|||||TWO_SIDED|95.0|9.3|25.5||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|9.3|
74008196|NCT03627767|147566485|SUPERIORITY||Difference in percentage|33.0|||<|0.0001|TWO_SIDED|95.0|25.7|40.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||40.4|25.7|< 0.0001
74008197|NCT03627767|147566485|SUPERIORITY||Difference in percentage|51.7|||<|0.0001|TWO_SIDED|95.0|44.6|58.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.8|44.6|< 0.0001
73863562|NCT03973905|147273372|OTHER||Vaccine Effectiveness|37.64|||||TWO_SIDED|95.0|-87.4|79.25|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix after pregnancy at preventing pertussis in infants \<2 months||79.25|-87.40|
74008198|NCT03627767|147566485|SUPERIORITY||Difference in percentage|19.2|||||TWO_SIDED|95.0|10.8|27.6||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||27.6|10.8|
74029992|NCT02433210|147614104|SUPERIORITY||||||=|0.445|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.445
74088649|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.64|||||TWO_SIDED|90.0|-6.57|-2.71|||Mixed Models Analysis|||30 minutes postdose||-2.71|-6.57|
74088650|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.49|||||TWO_SIDED|90.0|-4.59|-0.39|||Mixed Models Analysis|||1 hour postdose||-0.39|-4.59|
74088651|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.96|||||TWO_SIDED|90.0|-3.02|1.09|||Mixed Models Analysis|||1.5 hours postdose||1.09|-3.02|
74088652|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.64|||||TWO_SIDED|90.0|-0.46|3.73|||Mixed Models Analysis|||2 hours postdose||3.73|-0.46|
74088653|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.61|||||TWO_SIDED|90.0|-0.59|3.81|||Mixed Models Analysis|||2.5 hours postdose||3.81|-0.59|
74088654|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.41|||||TWO_SIDED|90.0|0.25|4.57|||Mixed Models Analysis|||3 hours postdose||4.57|0.25|
74088655|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|4.3|||||TWO_SIDED|90.0|2.48|6.12|||Mixed Models Analysis|||3.5 hours postdose||6.12|2.48|
74088656|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.15|||||TWO_SIDED|90.0|3.02|7.27|||Mixed Models Analysis|||4 hours postdose||7.27|3.02|
74088657|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.77|||||TWO_SIDED|90.0|0.75|4.79|||Mixed Models Analysis|||6 hours postdose||4.79|0.75|
74088658|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||TWO_SIDED|90.0|-0.55|4.05|||Mixed Models Analysis|||8 hours postdose||4.05|-0.55|
74088659|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||TWO_SIDED|90.0|-0.19|3.69|||Mixed Models Analysis|||12 hours postdose||3.69|-0.19|
74088660|NCT03465436|147730586|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.48|||||TWO_SIDED|90.0|-2.44|1.48|||Mixed Models Analysis|||24 hours postdose||1.48|-2.44|
74088661|NCT03465436|147730586|SUPERIORITY||LS Mean|7.07|||||TWO_SIDED|90.0|4.72|9.41|||Mixed Models Analysis|||30 minutes postdose||9.41|4.72|
74088662|NCT03465436|147730586|SUPERIORITY||LS Mean|11.81|||||TWO_SIDED|90.0|9.94|13.69|||Mixed Models Analysis|||1 hour postdose||13.69|9.94|
74088663|NCT03465436|147730586|SUPERIORITY||LS Mean|10.95|||||TWO_SIDED|90.0|9.16|12.74|||Mixed Models Analysis|||1.5 hours postdose||12.74|9.16|
73863563|NCT00576472|147273428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.0062|<|0.0001|TWO_SIDED|95.0|-0.0452|-0.0208|||ANOVA|||||-0.0208|-0.0452|<.0001
74088664|NCT03465436|147730586|SUPERIORITY||LS Mean|11.5|||||TWO_SIDED|90.0|9.5|13.43|||Mixed Models Analysis|||2 hours postdose||13.43|9.5|
74088665|NCT03465436|147730586|SUPERIORITY||LS Mean|10.81|||||TWO_SIDED|90.0|8.9|12.71|||Mixed Models Analysis|||2.5 hours postdose||12.71|8.9|
74088666|NCT03465436|147730586|SUPERIORITY||LS Mean|12.35|||||TWO_SIDED|90.0|10.42|14.28|||Mixed Models Analysis|||3 hours postdose||14.28|10.42|
74088667|NCT03465436|147730586|SUPERIORITY||LS Mean|12.65|||||TWO_SIDED|90.0|10.76|14.54|||Mixed Models Analysis|||3.5 hours postdose||14.54|10.76|
74088668|NCT03465436|147730586|SUPERIORITY||LS Mean|11.17|||||TWO_SIDED|90.0|9.23|13.1|||Mixed Models Analysis|||4 hours postdose||13.10|9.23|
74088669|NCT03465436|147730586|SUPERIORITY||LS Mean|8.12|||||TWO_SIDED|90.0|6.02|10.22|||Mixed Models Analysis|||6 hours postdose||10.22|6.02|
74088670|NCT03465436|147730586|SUPERIORITY||LS Mean|8.1|||||TWO_SIDED|90.0|6.01|10.19|||Mixed Models Analysis|||8 hours postdose||10.19|6.01|
74088671|NCT03465436|147730586|SUPERIORITY||LS Mean|6.26|||||TWO_SIDED|90.0|4.23|8.28|||Mixed Models Analysis|||12 hours postdose||8.28|4.23|
74088672|NCT03465436|147730586|SUPERIORITY||LS Mean|5.74|||||TWO_SIDED|90.0|3.47|8.01|||Mixed Models Analysis|||24 hours postdose||8.01|3.47|
74088673|NCT03465436|147730587|SUPERIORITY||LS Mean|32.89|||||TWO_SIDED|90.0|11.5|54.28|||Mixed Models Analysis|||30 minutes postdose||54.28|11.50|
74088674|NCT03465436|147730587|SUPERIORITY||LS Mean|100.15|||||TWO_SIDED|90.0|77.81|122.5|||Mixed Models Analysis|||1 hour postdose||122.50|77.81|
74088675|NCT03465436|147730587|SUPERIORITY||LS Mean|107.11|||||TWO_SIDED|90.0|83.31|130.91|||Mixed Models Analysis|||1.5 hours postdose||130.91|83.31|
74088676|NCT03465436|147730587|SUPERIORITY||LS Mean|74.48|||||TWO_SIDED|90.0|56.32|92.63|||Mixed Models Analysis|||2 hours postdose||92.63|56.32|
74088677|NCT03465436|147730587|SUPERIORITY||LS Mean|89.19|||||TWO_SIDED|90.0|68.77|109.61|||Mixed Models Analysis|||2.5 hours postdose||109.61|68.77|
74088678|NCT03465436|147730587|SUPERIORITY||LS Mean|74.98|||||TWO_SIDED|90.0|55.41|94.55|||Mixed Models Analysis|||3 hours postdose||94.55|55.41|
74088679|NCT03465436|147730587|SUPERIORITY||LS Mean|52.83|||||TWO_SIDED|90.0|36.03|69.63|||Mixed Models Analysis|||3.5 hours postdose||69.63|36.03|
74088680|NCT03465436|147730587|SUPERIORITY||LS Mean|42.1|||||TWO_SIDED|90.0|24.86|59.35|||Mixed Models Analysis|||4 hours postdose||59.35|24.86|
74088681|NCT03465436|147730587|SUPERIORITY||LS Mean|62.61|||||TWO_SIDED|90.0|42.39|82.83|||Mixed Models Analysis|||6 hours postdose||82.83|42.39|
74088682|NCT03465436|147730587|SUPERIORITY||LS Mean|56.05|||||TWO_SIDED|90.0|32.49|79.61|||Mixed Models Analysis|||8 hours postdose||79.61|32.49|
74088683|NCT03465436|147730587|SUPERIORITY||LS Mean|35.71|||||TWO_SIDED|90.0|11.79|59.63|||Mixed Models Analysis|||12 hours postdose||59.63|11.79|
74088684|NCT03465436|147730587|SUPERIORITY||LS Mean|-4.59|||||TWO_SIDED|90.0|-24.66|15.47|||Mixed Models Analysis|||24 hours postdose||15.47|-24.66|
73931966|NCT01416194|147394175|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.5|2.4|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.4|0.5|0.76
73931967|NCT01416194|147394176|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.3|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.9|0.3|0.01
73931968|NCT01416194|147394176|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.37|TWO_SIDED|95.0|0.4|1.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.5|0.4|0.37
73931969|NCT01416194|147394177|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.5|0.10
73931970|NCT01416194|147394177|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.19|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.2|0.4|0.19
73931971|NCT01416194|147394178|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
73931972|NCT01416194|147394178|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9|TWO_SIDED|95.0|0.4|2.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.1|0.4|0.90
73863564|NCT00576472|147273429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0285|STANDARD_ERROR_OF_MEAN|0.0046|<|0.0001|TWO_SIDED|95.0|0.019|0.038|||ANOVA|||||0.0380|0.0190|<.0001
73931973|NCT01416194|147394179|SUPERIORITY||Hazard Ratio (HR)|1.9|||<|0.01|TWO_SIDED|95.0|1.4|2.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.5|1.4|<0.01
73863565|NCT00576472|147273430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0144|STANDARD_ERROR_OF_MEAN|0.0064||0.025|TWO_SIDED|95.0|0.000204|0.0285|||ANOVA|||||0.0285|0.000204|0.025
73931974|NCT01416194|147394179|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.74|TWO_SIDED|95.0|0.7|1.3|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.3|0.7|0.74
73931975|NCT01416194|147394180|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.6|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.6|0.3|<0.01
73931976|NCT01416194|147394180|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.4|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.9|0.4|0.01
73931977|NCT01416194|147394181|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.01|TWO_SIDED|95.0|0.1|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.5|0.1|<0.01
73863566|NCT00576472|147273430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0442|STANDARD_ERROR_OF_MEAN|0.0093|<|0.0001|TWO_SIDED|95.0|0.0292|0.0591|||ANOVA|||||0.0591|0.0292|<.0001
73863567|NCT00576472|147273430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0491|STANDARD_ERROR_OF_MEAN|0.0064|<|0.0001|TWO_SIDED|95.0|0.0396|0.0586|||ANOVA|||||0.0586|0.0396|<.0001
73863568|NCT00576472|147273430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0298|STANDARD_ERROR_OF_MEAN|0.0083||0.0004|TWO_SIDED|95.0|0.00974|0.0499|||ANOVA|||||0.0499|0.00974|.0004
73931978|NCT01416194|147394181|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.06|TWO_SIDED|95.0|0.2|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.2|0.06
73931979|NCT01416194|147394182|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
73931980|NCT01416194|147394182|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.38|TWO_SIDED|95.0|0.5|1.4|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.4|0.5|0.38
73931981|NCT01416194|147394184|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.24|TWO_SIDED|95.0|0.9|1.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.5|0.9|0.24
74008199|NCT03627767|147566486|SUPERIORITY||Difference in percentage|2.6|||=|0.3994|TWO_SIDED|95.0|-3.3|8.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.4|-3.3|= 0.3994
73863569|NCT00576472|147273430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0347|STANDARD_ERROR_OF_MEAN|0.0047|<|0.0001|TWO_SIDED|95.0|0.025|0.0445|||ANOVA|||||0.0445|0.0250|<.0001
73863570|NCT00576472|147273430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.00494|STANDARD_ERROR_OF_MEAN|0.0083||0.552|TWO_SIDED|95.0|-0.00865|0.0185|||ANOVA|||||0.0185|-0.00865|.552
73863571|NCT00576472|147273431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.17|STANDARD_ERROR_OF_MEAN|1.93||0.0005|TWO_SIDED|95.0|-11.0|-3.3|||ANOVA|||||-3.3|-11.0|.0005
73863572|NCT00576472|147273432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.34|STANDARD_ERROR_OF_MEAN|1.59||0.0413|TWO_SIDED|95.0|-6.5|-0.1|||ANOVA|||||-0.1|-6.5|0.0413
73863573|NCT00576472|147273433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.74|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-11.0|-6.4|||ANOVA|||||-6.4|-11.0|<.0001
73863574|NCT00576472|147273434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.56|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|-12.0|-7.0|||ANOVA|||||-7.0|-12.0|<.0001
73863575|NCT00576472|147273435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|STANDARD_ERROR_OF_MEAN|1.81|<|0.0001|TWO_SIDED|95.0|4.4|11.6|||ANOVA|||||11.6|4.4|<.0001
73863576|NCT00576472|147273436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.03||0.8425|TWO_SIDED|95.0|-2.3|1.9|||ANOVA|||||1.9|-2.3|.8425
73863577|NCT00576472|147273437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|0.73||0.0016|TWO_SIDED|95.0|-3.9|-0.9|||ANOVA|||||-0.9|-3.9|.0016
73863578|NCT00576472|147273438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|1.04||0.8329|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|||||2.3|-1.9|.8329
73863579|NCT00576472|147273440|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||t-test, 2 sided|||||||0.0077
73863580|NCT00576472|147273440|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73863581|NCT00576472|147273440|SUPERIORITY_OR_OTHER|||||||0.1408||95.0|||||t-test, 2 sided|||||||0.1408
73863582|NCT00576472|147273441|SUPERIORITY_OR_OTHER|||||||0.0428||95.0|||||t-test, 2 sided|||||||0.0428
73863583|NCT00576472|147273441|SUPERIORITY_OR_OTHER|||||||0.0058||95.0|||||t-test, 2 sided|||||||0.0058
73863584|NCT00576472|147273441|SUPERIORITY_OR_OTHER|||||||0.4258||95.0|||||t-test, 2 sided|||||||0.4258
73863585|NCT00576472|147273442|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||t-test, 2 sided|||||||0.0035
73863586|NCT00576472|147273442|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
73863587|NCT00576472|147273442|SUPERIORITY_OR_OTHER|||||||0.4086||95.0|||||t-test, 2 sided|||||||0.4086
73863588|NCT00576472|147273443|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||||||0.0001
73863589|NCT00576472|147273443|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||t-test, 2 sided|||||||0.0007
73863590|NCT00576472|147273443|SUPERIORITY_OR_OTHER|||||||0.7007||95.0|||||t-test, 2 sided|||||||0.7007
73863591|NCT00576472|147273444|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
73863592|NCT00576472|147273444|SUPERIORITY_OR_OTHER|||||||0.0016||95.0|||||t-test, 2 sided|||||||0.0016
73863593|NCT00576472|147273444|SUPERIORITY_OR_OTHER|||||||0.6237||95.0|||||t-test, 2 sided|||||||0.6237
73863594|NCT00576472|147273445|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
73863595|NCT00576472|147273445|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<.0001
73863596|NCT00576472|147273445|SUPERIORITY_OR_OTHER|||||||0.6071||95.0|||||t-test, 2 sided|||||||0.6071
73863597|NCT00576472|147273446|SUPERIORITY_OR_OTHER|||||||0.1386||95.0|||||t-test, 2 sided|||||||0.1386
73863598|NCT00576472|147273446|SUPERIORITY_OR_OTHER|||||||0.0905||95.0|||||t-test, 2 sided|||||||0.0905
74029993|NCT02433210|147614105|SUPERIORITY||||||=|0.114|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.114
74029994|NCT02433210|147614105|SUPERIORITY||||||=|0.292|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.292
74029995|NCT02433210|147614105|SUPERIORITY||||||=|0.714|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.714
74029996|NCT02433210|147614105|SUPERIORITY||||||=|0.176|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.176
74029997|NCT02433210|147614105|SUPERIORITY||||||=|0.19|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.190
73863599|NCT00576472|147273446|SUPERIORITY_OR_OTHER|||||||0.8039||95.0|||||t-test, 2 sided|||||||0.8039
73863600|NCT00576472|147273447|SUPERIORITY_OR_OTHER|||||||0.7496||95.0|||||t-test, 2 sided|||||||0.7496
73863601|NCT00576472|147273447|SUPERIORITY_OR_OTHER|||||||0.9489||95.0|||||t-test, 2 sided|||||||0.9489
73863602|NCT00576472|147273447|SUPERIORITY_OR_OTHER|||||||0.7021||95.0|||||t-test, 2 sided|||||||0.7021
73863603|NCT00576472|147273448|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|||||||0.0190
73863604|NCT00576472|147273448|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
73863605|NCT00576472|147273448|SUPERIORITY_OR_OTHER|||||||0.1622||95.0|||||t-test, 2 sided|||||||0.1622
73863606|NCT00576472|147273449|SUPERIORITY_OR_OTHER|||||||0.1202||95.0|||||t-test, 2 sided|||||||0.1202
73863607|NCT00576472|147273449|SUPERIORITY_OR_OTHER|||||||0.0103||95.0|||||t-test, 2 sided|||||||0.0103
73863608|NCT00576472|147273449|SUPERIORITY_OR_OTHER|||||||0.2831||95.0|||||t-test, 2 sided|||||||0.2831
73863609|NCT00576472|147273450|SUPERIORITY_OR_OTHER|||||||0.7027||95.0|||||t-test, 2 sided|||||||0.7027
73863610|NCT00576472|147273451|SUPERIORITY_OR_OTHER|||||||0.7493||95.0|||||t-test, 2 sided|||||||0.7493
73863611|NCT00576472|147273452|SUPERIORITY_OR_OTHER|||||||0.7339||95.0|||||t-test, 2 sided|||||||0.7339
73863612|NCT00576472|147273453|SUPERIORITY_OR_OTHER|||||||0.6148||95.0|||||t-test, 2 sided|||||||0.6148
73863613|NCT00576472|147273454|SUPERIORITY_OR_OTHER|||||||0.4456||95.0|||||t-test, 2 sided|||||||0.4456
73863614|NCT00576472|147273455|SUPERIORITY_OR_OTHER|||||||0.5866||95.0|||||t-test, 2 sided|||||||0.5866
73863615|NCT00576472|147273456|SUPERIORITY_OR_OTHER|||||||0.8918||95.0|||||t-test, 2 sided|||||||0.8918
73863616|NCT00576472|147273457|SUPERIORITY_OR_OTHER|||||||0.4427||95.0|||||t-test, 2 sided|||||||0.4427
73971578|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-24.723||||0.0197|TWO_SIDED|95.0|-45.473|-3.973|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-3.973|-45.473|0.0197
73971579|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-13.595||||0.2353|TWO_SIDED|95.0|-36.08|8.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||8.891|-36.080|0.2353
73971580|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-4.759||||0.7329|TWO_SIDED|95.0|-32.159|22.641|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||22.641|-32.159|0.7329
73971581|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-21.962||||0.542|TWO_SIDED|95.0|-62.989|19.065|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||19.065|-62.989|0.5420
73971582|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.591||||0.5234|TWO_SIDED|95.0|-77.049|23.866|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||23.866|-77.049|0.5234
73971583|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-20.761||||0.5975|TWO_SIDED|95.0|-61.867|20.344|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||20.344|-61.867|0.5975
74029998|NCT02433210|147614105|SUPERIORITY|||||||-0.009|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||-0.009
74029999|NCT02433210|147614105|SUPERIORITY||||||=|0.911|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.911
74030000|NCT02433210|147614105|SUPERIORITY||||||=|0.388|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.388
73863617|NCT00576472|147273458|SUPERIORITY_OR_OTHER|||||||0.4203||95.0|||||t-test, 2 sided|||||||0.4203
73863618|NCT00576472|147273459|SUPERIORITY_OR_OTHER|||||||0.5754||95.0|||||t-test, 2 sided|||||||0.5754
73863619|NCT00576472|147273460|SUPERIORITY_OR_OTHER|||||||0.0251||95.0|||||t-test, 2 sided|||||||0.0251
73863620|NCT00576472|147273461|SUPERIORITY_OR_OTHER|||||||0.1049||95.0|||||t-test, 2 sided|||||||0.1049
73863621|NCT04405245|147273463|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.366||0.807|TWO_SIDED|95.0|-0.63|0.81|||ANCOVA|||||0.81|-0.63|0.8070
73863622|NCT04405245|147273463|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.365||0.013|TWO_SIDED|95.0|-1.64|-0.2|||ANCOVA|||||-0.20|-1.64|0.0130
73863623|NCT02391961|147273474|SUPERIORITY|||||||0.842672|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: average PSR at baseline and after 3 hours on dalfampridine, and average PSR at baseline and after 3 hours on placebo.||||0.842672
73863624|NCT02391961|147273475|SUPERIORITY|||||||0.972866|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: average PTD at baseline and after 3 hours on dalfampridine, and average PTD at baseline and after 3 hours on placebo.||||0.972866
73863625|NCT02391961|147273476|SUPERIORITY|||||||0.95|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: RA at baseline and after 3 hours on dalfampridine, and RA at baseline and after 3 hours on placebo.||||0.95
73863626|NCT02391961|147273477|SUPERIORITY|||||||0.9|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: MRS at baseline and after 3 hours on dalfampridine, and MRS at baseline and after 3 hours on placebo.||||0.9
73863627|NCT02391961|147273478|SUPERIORITY|||||||0.990995|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: 25 FWT at baseline and after 3 hours on dalfampridine, and 25 FWT at baseline and after 3 hours on placebo.||||0.990995
73863628|NCT02391961|147273479|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to the 2 groups, mean VFQ-25 scores on dalfampridine vs mean VFQ-25 scores on placebo||||0.71
73863629|NCT02391961|147273480|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to the 2 groups, mean 10-item NOS scores on dalfampridine vs mean 10-item NOS scores on placebo||||0.95
73863630|NCT03263780|147273485|SUPERIORITY||Sensitivity|0.25||||0.056|TWO_SIDED|95.0|0.19|0.46||mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+)||0.46|0.19|0.056
73863631|NCT03263780|147273485|SUPERIORITY||Sensitivity|0.56||||0.56|TWO_SIDED|95.0|0.44|0.78||mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)||0.78|0.44|0.56
73863632|NCT03263780|147273485|SUPERIORITY||Sensitivity|0.22||||0.06|TWO_SIDED|95.0|0.17|0.47||mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+)||0.47|0.17|0.060
73863633|NCT03263780|147273485|SUPERIORITY||Sensitivity|0.5||||0.083|TWO_SIDED|95.0|0.39|0.74||mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)||0.74|0.39|0.083
73863634|NCT03263780|147273486|SUPERIORITY||Sensitivity|0.35||||0.096|TWO_SIDED|95.0|0.26|0.65||mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+)||0.65|0.26|0.096
73863635|NCT03263780|147273486|SUPERIORITY||Sensitivity|0.6||||0.317|TWO_SIDED|95.0|0.46|0.9||mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)||0.90|0.46|0.317
73863636|NCT03263780|147273486|SUPERIORITY||Sensitivity|0.3||||0.063|TWO_SIDED|95.0|0.23|0.66||mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+)||0.66|0.23|0.063
73863637|NCT03263780|147273486|SUPERIORITY||Sensitivity|0.6||||0.317|TWO_SIDED|95.0|0.46|0.9||mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)||0.90|0.46|0.317
73863638|NCT02219503|147273520|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Non-inferiority was to be declared if the lower confidence bound was greater than 72.7%.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|||100.0|94.0|
73863639|NCT02219503|147273520|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|The superiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Superiority was declared if the lower confidence bound was greater than 83.2%.||100.0|94.0|
73863640|NCT01561963|147273546|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% confidence interval (CI) limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|96.35|||||TWO_SIDED|90.0|88.56|104.82|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUCt of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||104.82|88.56|
74088685|NCT03465436|147730587|SUPERIORITY||LS Mean|56.53|||||TWO_SIDED|90.0|36.72|76.35|||Mixed Models Analysis|||30 minutes postdose||76.35|36.72|
73971584|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-13.337||||0.9331|TWO_SIDED|95.0|-62.853|36.179|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||36.179|-62.853|0.9331
73971585|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-19.964||||0.2444|TWO_SIDED|95.0|-53.637|13.709|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||13.709|-53.637|0.2444
73971586|NCT04800211|147483697|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-13.254||||0.5169|TWO_SIDED|95.0|-53.427|26.919|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||26.919|-53.427|0.5169
73971587|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.174||||0.1359|TWO_SIDED|95.0|-93.12|12.772|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||12.772|-93.120|0.1359
73971588|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-71.725||||0.0129|TWO_SIDED|95.0|-127.961|-15.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.490|-127.961|0.0129
73971589|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-37.308||||0.3262|TWO_SIDED|95.0|-112.293|37.678|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||37.678|-112.293|0.3262
74008200|NCT03627767|147566486|SUPERIORITY||Difference in percentage|1.8|||=|0.5542|TWO_SIDED|95.0|-4.1|7.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||7.8|-4.1|= 0.5542
73971590|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-20.012||||0.4343|TWO_SIDED|95.0|-70.468|30.444|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||30.444|-70.468|0.4343
73971591|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-44.657||||0.0967|TWO_SIDED|95.0|-97.481|8.167|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.167|-97.481|0.0967
73971592|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-28.974||||0.4198|TWO_SIDED|95.0|-99.915|41.966|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||41.966|-99.915|0.4198
73971593|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-33.141||||0.2121|TWO_SIDED|95.0|-85.475|19.193|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||19.193|-85.475|0.2121
73971594|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|15.799||||0.5445|TWO_SIDED|95.0|-35.614|67.212|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||67.212|-35.614|0.5445
74008201|NCT03627767|147566486|SUPERIORITY||Difference in percentage|-0.8|||||TWO_SIDED|95.0|-6.5|5.0||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.0|-6.5|
74008202|NCT03627767|147566486|SUPERIORITY||Difference in percentage|37.5|||<|0.0001|TWO_SIDED|95.0|30.2|44.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.9|30.2|< 0.0001
74030001|NCT02433210|147614105|SUPERIORITY||||||=|0.337|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.337
73971595|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.583||||0.9534|TWO_SIDED|95.0|-51.951|55.116|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||55.116|-51.951|0.9534
73931982|NCT01416194|147394184|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.59|TWO_SIDED|95.0|0.8|1.6|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.6|0.8|0.59
73931983|NCT01416194|147394185|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.03|TWO_SIDED|95.0|0.6|1.0|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.0|0.6|0.03
73931984|NCT01416194|147394185|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.19|TWO_SIDED|95.0|0.6|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.6|0.19
73931985|NCT01416194|147394186|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.01|TWO_SIDED|95.0|0.2|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.5|0.2|<0.01
73931986|NCT01416194|147394186|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.24|TWO_SIDED|95.0|0.3|1.3|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.3|0.3|0.24
73931987|NCT01222494|147394187|SUPERIORITY|||||||0.01||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.01
73931988|NCT01222494|147394188|SUPERIORITY|||||||0.04||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.04
73931989|NCT01222494|147394189|SUPERIORITY|||||||0.7||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.70
73931990|NCT01222494|147394190|SUPERIORITY|||||||0.003||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.003
73931991|NCT04574362|147394235|SUPERIORITY||Risk Difference (RD)|9.2|||<|0.0001|TWO_SIDED|95.0|5.4|13.0|||Cochran-Mantel-Haenszel||Risk difference and associated 95 percent (%) confidence interval (CI) were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||13.0|5.4|<0.0001
73931992|NCT04574362|147394236|SUPERIORITY||Risk Difference (RD)|14.8|||<|0.0001|TWO_SIDED|95.0|9.6|20.0|||Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||20.0|9.6|<0.0001
73931993|NCT04574362|147394237|SUPERIORITY||Risk Difference (RD)|18.1|||<|0.0001|TWO_SIDED|95.0|13.0|23.3|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||23.3|13.0|<0.0001
73931994|NCT04574362|147394238|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.0001|TWO_SIDED|95.0|11.4|22.3|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||22.3|11.4|<0.0001
73931995|NCT04574362|147394239|SUPERIORITY||Risk Difference (RD)|-11.5|||<|0.0001|TWO_SIDED|95.0|-15.0|-8.0|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||-8.0|-15.0|<0.0001
73931996|NCT04574362|147394240|SUPERIORITY||Risk Difference (RD)|7.7|||<|0.0001|TWO_SIDED|95.0|4.3|11.2|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk differences and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||11.2|4.3|<0.0001
73931997|NCT04574362|147394241|SUPERIORITY||Risk difference|7.7|||<|0.0001|TWO_SIDED|95.0|4.4|11.0|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||11.0|4.4|<0.0001
73931998|NCT04574362|147394242|SUPERIORITY||Risk difference|-0.7||||0.2057|TWO_SIDED|95.0|-1.9|0.4||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|15 minutes post-dose||0.4|-1.9|0.2057
73931999|NCT04574362|147394242|SUPERIORITY||Risk Difference (RD)|0.0||||0.9702|TWO_SIDED|95.0|-1.1|1.1||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|30 minutes post-dose||1.1|-1.1|0.9702
74008203|NCT03627767|147566486|SUPERIORITY||Difference in percentage|63.3|||<|0.0001|TWO_SIDED|95.0|56.8|69.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.8|56.8|< 0.0001
74008204|NCT03627767|147566486|SUPERIORITY||Difference in percentage|25.5|||||TWO_SIDED|95.0|17.7|33.4||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||33.4|17.7|
74030002|NCT02433210|147614105|SUPERIORITY||||||=|0.575|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.575
74030003|NCT02433210|147614105|SUPERIORITY||||||=|0.88|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.880
73932000|NCT04574362|147394242|SUPERIORITY||Risk Difference (RD)|1.0||||0.2419|TWO_SIDED|95.0|-0.7|2.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|45 minutes post-dose||2.8|-0.7|0.2419
73932001|NCT04574362|147394242|SUPERIORITY||Risk Difference (RD)|2.4||||0.0597|TWO_SIDED|95.0|-0.1|4.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|60 minutes post-dose||4.8|-0.1|0.0597
73932002|NCT04574362|147394242|SUPERIORITY||Risk Difference (RD)|5.2||||0.0012|TWO_SIDED|95.0|2.1|8.4||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|90 minutes post-dose||8.4|2.1|0.0012
73932003|NCT04574362|147394243|SUPERIORITY||Risk Difference (RD)|-0.7||||0.6809|TWO_SIDED|95.0|-3.9|2.5||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|15 minutes post-dose||2.5|-3.9|0.6809
73932004|NCT04574362|147394243|SUPERIORITY||Risk Difference (RD)|2.2||||0.2586|TWO_SIDED|95.0|-1.6|6.0||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|30 minutes post-dose||6.0|-1.6|0.2586
73932005|NCT04574362|147394243|SUPERIORITY||Risk Difference (RD)|4.5||||0.0421|TWO_SIDED|95.0|0.2|8.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|45 minutes post-dose||8.8|0.2|0.0421
73932006|NCT04574362|147394243|SUPERIORITY||Risk Difference (RD)|6.6||||0.0066|TWO_SIDED|95.0|1.8|11.3||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|60 minutes post-dose||11.3|1.8|0.0066
73932007|NCT04574362|147394243|SUPERIORITY||Risk Difference (RD)|9.9||||0.0002|TWO_SIDED|95.0|4.8|14.9||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|90 minutes post-dose||14.9|4.8|0.0002
73932008|NCT04574362|147394244|SUPERIORITY||Risk Difference (RD)|-10.4||||0.1148|TWO_SIDED|95.0|-23.5|2.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||2.8|-23.5|0.1148
74030004|NCT02433210|147614105|SUPERIORITY||||||=|0.731|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.731
74030005|NCT03046472|147614106|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
74030006|NCT03046472|147614107|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
74030007|NCT03046472|147614108|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
74030008|NCT01614769|147614115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|||||TWO_SIDED|90.0|-22.98|51.8||||||||51.80|-22.98|
74030009|NCT01614769|147614115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.33|||||TWO_SIDED|90.0|-2.08|72.74||||||||72.74|-2.08|
74030010|NCT01614769|147614116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.21|0.0||||||||0.00|-0.21|
74030011|NCT01614769|147614116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|90.0|-0.24|-0.03||||||||-0.03|-0.24|
74030012|NCT01614769|147614117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.03|||||TWO_SIDED|90.0|-11.12|1.05||||||||1.05|-11.12|
74030013|NCT01614769|147614117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.27|||||TWO_SIDED|90.0|-13.3|-1.24||||||||-1.24|-13.30|
73932009|NCT02002767|147394247|OTHER||Geometric Least Squares Mean(GLSM) Ratio|149.05|||||TWO_SIDED|90.0|116.62|190.49||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||190.49|116.62|
73932010|NCT02002767|147394248|OTHER||GLSM Ratio|149.9|||||TWO_SIDED|90.0|116.97|192.11||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||192.11|116.97|
73932011|NCT02002767|147394249|OTHER||GLSM Ratio|110.85|||||TWO_SIDED|90.0|90.76|135.38||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||135.38|90.76|
73932012|NCT00812929|147394254|SUPERIORITY||Mean Difference (Net)|1.29|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|-1.56|4.13||||||||4.13|-1.56|
73932013|NCT00812929|147394254|SUPERIORITY||Mean Difference (Net)|0.53|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|-2.32|3.37||||||||3.37|-2.32|
73932014|NCT00812929|147394254|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|1.441|||TWO_SIDED|95.0|-2.52|3.18||||||||3.18|-2.52|
73932015|NCT00812929|147394254|SUPERIORITY||Mean Difference (Net)|2.53|STANDARD_ERROR_OF_MEAN|1.438|||TWO_SIDED|95.0|-0.31|5.37||||||||5.37|-0.31|
73932016|NCT00812929|147394255|SUPERIORITY||Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|1.638|||TWO_SIDED|95.0|-0.72|5.75||||||2 Hours||5.75|-0.72|
73932017|NCT00812929|147394255|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|1.247|||TWO_SIDED|95.0|-2.34|2.58||||||9.5 Hours||2.58|-2.34|
73932018|NCT00812929|147394255|SUPERIORITY||Mean Difference (Net)|2.6|STANDARD_ERROR_OF_MEAN|1.637|||TWO_SIDED|95.0|-0.64|5.84||||||2 Hours||5.84|-0.64|
73932019|NCT00812929|147394255|SUPERIORITY||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|1.247|||TWO_SIDED|95.0|-1.7|3.22||||||9.5 Hours||3.22|-1.70|
73932020|NCT00812929|147394255|SUPERIORITY||Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|1.639|||TWO_SIDED|95.0|-0.45|6.03||||||2 Hours||6.03|-0.45|
73932021|NCT00812929|147394255|SUPERIORITY||Mean Difference (Net)|3.49|STANDARD_ERROR_OF_MEAN|1.248|||TWO_SIDED|95.0|1.02|5.95||||||9.5 Hours||5.95|1.02|
73932022|NCT00812929|147394255|SUPERIORITY||Mean Difference (Net)|6.3|STANDARD_ERROR_OF_MEAN|1.637|||TWO_SIDED|95.0|3.06|9.54||||||2 Hours||9.54|3.06|
73932023|NCT00812929|147394255|SUPERIORITY||Mean Difference (Net)|2.27|STANDARD_ERROR_OF_MEAN|1.245|||TWO_SIDED|95.0|-0.19|4.73||||||9.5 Hours||4.73|-0.19|
73932024|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-1.37|3.25|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.25|-1.37|
73932025|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.878|||TWO_SIDED|95.0|-1.66|1.8|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||1.80|-1.66|
73932026|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-0.82|2.63|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||2.63|-0.82|
73932027|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|1.12|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|-1.19|3.43|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.43|-1.19|
73932028|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|1.22|STANDARD_ERROR_OF_MEAN|0.878|||TWO_SIDED|95.0|-0.51|2.95|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||2.95|-0.51|
73932029|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-1.55|1.9|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||1.90|-1.55|
73932030|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|1.51|STANDARD_ERROR_OF_MEAN|1.171|||TWO_SIDED|95.0|-0.8|3.82|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.82|-0.80|
73932031|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|0.879|||TWO_SIDED|95.0|1.57|5.03|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||5.03|1.57|
73932032|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.874|||TWO_SIDED|95.0|-1.83|1.62|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||1.62|-1.83|
73932033|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|3.17|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|0.86|5.48|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||5.48|0.86|
73932034|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|0.877|||TWO_SIDED|95.0|0.38|3.84|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||3.84|0.38|
73932035|NCT00812929|147394256|SUPERIORITY||Mean Difference (Net)|1.72|STANDARD_ERROR_OF_MEAN|0.872|||TWO_SIDED|95.0|0.0|3.44|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||3.44|-0.00|
73932036|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.71|2.21|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||2.21|0.71|
73932037|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.59|2.06|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||2.06|0.59|
74088686|NCT03465436|147730587|SUPERIORITY||LS Mean|103.3|||||TWO_SIDED|90.0|83.88|122.72|||Mixed Models Analysis|||1 hour postdose||122.72|83.88|
73863641|NCT01561963|147273546|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|27.88|||||TWO_SIDED|90.0|25.63|30.34|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUCt of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||30.34|25.63|
73863642|NCT01561963|147273547|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|95.71|||||TWO_SIDED|90.0|87.99|104.12|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUC∞ of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||104.12|87.99|
73863643|NCT01561963|147273547|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|27.96|||||TWO_SIDED|90.0|25.7|30.41|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUC∞ of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||30.41|25.70|
73863644|NCT01561963|147273548|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|113.07|||||TWO_SIDED|90.0|103.18|123.91|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of Cmax of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||123.91|103.18|
73863645|NCT01561963|147273548|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|56.8|||||TWO_SIDED|90.0|51.84|62.25|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of Cmax of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||62.25|51.84|
73863646|NCT01561963|147273549|OTHER||Median Difference|-0.25||||0.2656|TWO_SIDED|90.0|-0.75|0.0|||Wilcoxon signed rank test||Apremilast + IV Rifampin - Apremilast Alone|Tmax was analyzed using nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||0.00|-0.75|0.2656
73863647|NCT01561963|147273549|OTHER||Median Difference|-0.5||||0.1141|TWO_SIDED|90.0|-1.0|0.0|||Wilcoxon signed rank test||Apremilast + Multiple Dose Oral Rifampin - Apremilast Alone|Tmax was analyzed using nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||0.00|-1.00|0.1141
73863648|NCT00162266|147273557|SUPERIORITY_OR_OTHER||Point Estimate of Difference|25.6|||<|0.001|TWO_SIDED|95.0|12.8|38.4|||Chi-squared|||||38.4|12.8|<0.001
73863649|NCT00162266|147273557|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.31|TWO_SIDED|95.0|-6.2|19.4|||Chi-squared|||||19.4|-6.2|0.31
73863650|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.9||||0.283|TWO_SIDED|95.0|-4.9|16.7|||Chi-squared|||Response on Day 15||16.7|-4.9|0.283
73863651|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-11.6||||0.015|TWO_SIDED|95.0|-20.9|-2.3|||Chi-squared|||Response on Day 15||-2.3|-20.9|0.015
73932038|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|1.78|||||TWO_SIDED|95.0|0.93|3.43|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.43|0.93|
73932039|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.81|2.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||2.48|0.81|
73932040|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|1.93|||||TWO_SIDED|95.0|1.01|3.66|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||3.66|1.01|
74008205|NCT03627767|147566486|SUPERIORITY||Difference in percentage|36.9|||<|0.0001|TWO_SIDED|95.0|29.9|44.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.0|29.9|< 0.0001
74088687|NCT03465436|147730587|SUPERIORITY||LS Mean|94.21|||||TWO_SIDED|90.0|75.15|113.26|||Mixed Models Analysis|||1.5 hours postdose||113.26|75.15|
73863652|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.5||||0.067|TWO_SIDED|95.0|-0.8|23.8|||Chi-squared|||Response on Day 30||23.8|-0.8|0.067
73863653|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-9.3||||0.113|TWO_SIDED|95.0|-20.8|2.2|||Chi-squared|||Response on Day 30||2.2|-20.8|0.113
73863654|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|22.1|||<|0.001|TWO_SIDED|95.0|9.3|34.8|||Chi-squared|||Response on Day 60||34.8|9.3|<0.001
73932041|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.86|3.25|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.25|0.86|
73863655|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-1.1||||0.86|TWO_SIDED|95.0|-13.5|11.3|||Chi-squared|||Response on Day 60||11.3|-13.5|0.86
73863656|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|18.6||||0.004|TWO_SIDED|95.0|5.9|31.4|||Chi-squared|||Response on Day 90||31.4|5.9|0.004
73863657|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.8||||0.664|TWO_SIDED|95.0|-9.8|15.4|||Chi-squared|||Response on Day 90||15.4|-9.8|0.664
73863658|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|23.9|||<|0.001|TWO_SIDED|95.0|11.1|36.7|||Chi-squared|||Response on Day 120||36.7|11.1|<0.001
73863659|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.9||||0.292|TWO_SIDED|95.0|-6.0|19.9|||Chi-squared|||Response on Day 120||19.9|-6.0|0.292
73863660|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|23.0|||<|0.001|TWO_SIDED|95.0|10.2|35.8|||Chi-squared|||Response on Day 150||35.8|10.2|<0.001
73863661|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.5||||0.193|TWO_SIDED|95.0|-4.3|21.3|||Chi-squared|||Response on Day 150||21.3|-4.3|0.193
73863662|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|25.6|||<|0.001|TWO_SIDED|95.0|12.8|38.4|||Chi-squared|||Response on Day 180||38.4|12.8|<0.001
73863663|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.31||95.0|-6.2|19.4|||Chi-squared|||Response on Day 180||19.4|-6.2|0.31
73863664|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|27.3|||<|0.001|TWO_SIDED|95.0|14.5|40.1|||Chi-squared|||Response on Day 240||40.1|14.5|<0.001
73863665|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.7||||0.384|TWO_SIDED|95.0|-7.1|18.4|||Chi-squared|||Response on Day 240||18.4|-7.1|0.384
73863666|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|29.0|||<|0.001|TWO_SIDED|95.0|16.2|41.8|||Chi-squared|||Response on Day 300||41.8|16.2|<0.001
73863667|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.6||||0.476|TWO_SIDED|95.0|-8.0|17.2|||Chi-squared|||Response on Day 300||17.2|-8.0|0.476
73932042|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|1.19|3.69|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||3.69|1.19|
73932043|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|5.49|||||TWO_SIDED|95.0|2.75|10.94|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||10.94|2.75|
73932044|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|1.91|||||TWO_SIDED|95.0|1.0|3.64|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.64|1.00|
73932045|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|3.6|||||TWO_SIDED|95.0|2.0|6.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||6.48|2.00|
73932046|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|2.03|||||TWO_SIDED|95.0|1.07|3.87|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||3.87|1.07|
73932047|NCT00812929|147394257|SUPERIORITY||Hazard Ratio (HR)|6.07|||||TWO_SIDED|95.0|2.9|12.71|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||12.71|2.90|
73932048|NCT02832674|147394323|SUPERIORITY|||||||0.05|TWO_SIDED|90.0|||||Fisher Exact|||The primary endpoint was an evaluation of the proportion of subjects with ≥ 20 mm2 lift at Day 90.||||0.05
73932049|NCT02832674|147394324|OTHER|Binomial test of proportions||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
73932050|NCT02832674|147394325|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared|||Analysis of all effectiveness endpoints was conducted on the ITT population and on the PP population.|The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
73863668|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|26.5|||<|0.001|TWO_SIDED|95.0|13.7|39.3|||Chi-squared|||Response on Day 360||39.3|13.7|<0.001
73863669|NCT00162266|147273558|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.8||||0.377|TWO_SIDED|95.0|-7.0|18.6|||Chi-squared|||Response on Day 360||18.6|-7.0|0.377
73863670|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-0.8||||0.679|TWO_SIDED|95.0|-4.5|2.9|||Chi-squared|||Response on Day 15||2.9|-4.5|0.679
73863671|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-2.5||||0.101|TWO_SIDED|95.0|-5.5|0.5|||Chi-squared|||Response on Day 15||0.5|-5.5|0.101
73863672|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.0||||0.039|TWO_SIDED|95.0|0.4|15.7|||Chi-squared|||Response on Day 30||15.7|0.4|0.039
73863673|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-2.1||||0.474|TWO_SIDED|95.0|-7.7|3.6|||Chi-squared|||Response on Day 30||3.6|-7.7|0.474
73863674|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.192|TWO_SIDED|95.0|-3.3|16.5|||Chi-squared|||Response on Day 60||16.5|-3.3|0.192
73863675|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-1.8||||0.702|TWO_SIDED|95.0|-11.0|7.4|||Chi-squared|||Response on Day 60||7.4|-11.0|0.702
73863676|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.7||||0.02|TWO_SIDED|95.0|1.8|21.7|||Chi-squared|||Response on Day 90||21.7|1.8|0.02
73863677|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.5||||0.339|TWO_SIDED|95.0|-4.8|13.8|||Chi-squared|||Response on Day 90||13.8|-4.8|0.339
73863678|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|17.9||||0.001|TWO_SIDED|95.0|7.0|28.9|||Chi-squared|||Response on Day 120||28.9|7.0|0.001
73863679|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.0||||0.682|TWO_SIDED|95.0|-7.6|11.7|||Chi-squared|||Response on Day 120||11.7|-7.6|0.682
73863680|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|20.6|||<|0.001|TWO_SIDED|95.0|9.3|31.8|||Chi-squared|||Response on Day 150||31.8|9.3|<0.001
73863681|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|1.2||||0.813|TWO_SIDED|95.0|-8.6|10.9|||Chi-squared|||Response on Day 150||10.9|-8.6|0.813
74088688|NCT03465436|147730587|SUPERIORITY||LS Mean|83.49|||||TWO_SIDED|90.0|67.98|99.0|||Mixed Models Analysis|||2 hours postdose||99.00|67.98|
73863682|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|24.8|||<|0.001|TWO_SIDED|95.0|13.8|35.7|||Chi-squared|||Response on Day 180||35.7|13.8|<0.001
73932051|NCT02832674|147394326|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
73932052|NCT02832674|147394327|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
73932053|NCT02832674|147394328|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
73932054|NCT00678691|147394331|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||all p-values come from one model analysis and are therefore included in free text as such|piecewise model|A piecewise statistical model results for between group differences: P=.390 (baseline through week 5), p=.775 (week 5 - week 8||Authors expected armodafinal to work better than placebo reducing BFI scale scores by 30%. A piecewise statistical model was used to compare baseline scores against those over through week 8. Piecewise results for between group differences for BFI Scores: P=.390 (baseline through week 5), p=.775 (week 5 - week 8).||||<0.05
73932055|NCT03161314|147394398|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Baseline||||0.660
73932056|NCT03161314|147394398|SUPERIORITY|||||||0.734|||||||t-test, 2 sided|||2 weeks after the intervention||||0.734
73932057|NCT03161314|147394398|SUPERIORITY|||||||0.629|||||||t-test, 2 sided|||4 weeks after the intervention||||0.629
73932058|NCT03161314|147394398|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||1-month follow-up||||0.752
73932059|NCT03161314|147394398|SUPERIORITY|||||||0.512|||||||t-test, 2 sided|||2-month follow-up||||0.512
73932060|NCT03161314|147394398|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
73932061|NCT03161314|147394398|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
73863683|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.1||||0.027|TWO_SIDED|95.0|1.2|20.9|||Chi-squared|||Response on Day 180||20.9|1.2|0.027
73932062|NCT03161314|147394399|SUPERIORITY|||||||0.128|||||||t-test, 2 sided|||Baseline||||0.128
73932063|NCT03161314|147394399|SUPERIORITY|||||||0.889|||||||t-test, 2 sided|||2 weeks after the intervention||||0.889
73932064|NCT03161314|147394399|SUPERIORITY|||||||0.793|||||||t-test, 2 sided|||4 weeks after the intervention||||0.793
73932065|NCT03161314|147394399|SUPERIORITY|||||||0.602|||||||t-test, 2 sided|||1-month follow-up||||0.602
73932066|NCT03161314|147394399|SUPERIORITY|||||||0.574|||||||t-test, 2 sided|||2-month follow-up||||0.574
73932067|NCT03161314|147394399|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
73932068|NCT03161314|147394399|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
73932069|NCT03161314|147394400|SUPERIORITY|||||||0.374|||||||t-test, 2 sided|||Baseline||||0.374
73932070|NCT03161314|147394400|SUPERIORITY|||||||0.674|||||||t-test, 2 sided|||2 weeks after the intervention||||0.674
73932071|NCT03161314|147394400|SUPERIORITY|||||||0.781|||||||t-test, 2 sided|||4 weeks after the intervention||||0.781
73932072|NCT03161314|147394400|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||1-month follow-up||||0.778
73932073|NCT03161314|147394400|SUPERIORITY|||||||0.727|||||||t-test, 2 sided|||2-month follow-up||||0.727
73863684|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|15.5||||0.008|TWO_SIDED|95.0|4.0|27.0|||Chi-squared|||Response on Day 240||27.0|4.0|0.008
73863685|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|0.8||||0.885|TWO_SIDED|95.0|-9.8|11.4|||Chi-squared|||Response on Day 240||11.4|-9.8|0.885
73932074|NCT03161314|147394400|SUPERIORITY|||||||0.014|||||||ANOVA|||Within group comparison||||0.014
73932075|NCT03161314|147394400|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
73932076|NCT03161314|147394401|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Baseline||||0.390
73932077|NCT03161314|147394401|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||2 weeks after the intervention||||0.770
73932078|NCT03161314|147394401|SUPERIORITY|||||||0.603|||||||t-test, 2 sided|||4 weeks after the intervention||||0.603
73932079|NCT03161314|147394401|SUPERIORITY|||||||0.922|||||||t-test, 2 sided|||1-month follow-up||||0.922
73932080|NCT03161314|147394401|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||2-month follow-up||||0.560
73932081|NCT03161314|147394401|SUPERIORITY|||||||0.181|||||||ANOVA|||Within group comparison||||0.181
73932082|NCT03161314|147394401|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
73932083|NCT03161314|147394402|SUPERIORITY|||||||0.334|||||||t-test, 2 sided|||Baseline||||0.334
73932084|NCT03161314|147394402|SUPERIORITY|||||||0.766|||||||t-test, 2 sided|||2 weeks after the intervention||||0.766
73932085|NCT03161314|147394402|SUPERIORITY|||||||0.598|||||||t-test, 2 sided|||4 weeks after the intervention||||0.598
73932086|NCT03161314|147394402|SUPERIORITY|||||||0.682|||||||t-test, 2 sided|||1-month follow-up||||0.682
73932087|NCT03161314|147394402|SUPERIORITY|||||||0.707|||||||t-test, 2 sided|||2-month follow-up||||0.707
73932088|NCT03161314|147394402|SUPERIORITY|||||||0.008|||||||ANOVA|||Within group comparison||||0.008
73932089|NCT03161314|147394402|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
73932090|NCT03161314|147394403|SUPERIORITY|||||||0.287|||||||t-test, 2 sided|||Baseline||||0.287
73932091|NCT03161314|147394403|SUPERIORITY|||||||0.861|||||||t-test, 2 sided|||2 weeks after the intervention||||0.861
73932092|NCT03161314|147394403|SUPERIORITY|||||||0.641|||||||t-test, 2 sided|||4 weeks after the intervention||||0.641
73932093|NCT03161314|147394403|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||1-month follow-up||||0.864
73932094|NCT03161314|147394403|SUPERIORITY|||||||0.888|||||||t-test, 2 sided|||2-month follow-up||||0.888
73932095|NCT03161314|147394403|SUPERIORITY|||||||0.262|||||||ANOVA|||Within group comparison||||0.262
73932096|NCT03161314|147394403|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
74030014|NCT01958671|147614124|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.99|||<|0.001|TWO_SIDED|95.0|-1.22|-0.76|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.76|-1.22|<0.001
73863686|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|24.0|||<|0.001|TWO_SIDED|95.0|12.6|35.4|||Chi-squared|||Response on Day 300||35.4|12.6|<0.001
73863687|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.8||||0.19|TWO_SIDED|95.0|-3.4|16.9|||Chi-squared|||Response on Day 300||16.9|-3.4|0.19
73863688|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|21.6|||<|0.001|TWO_SIDED|95.0|9.7|33.4|||Chi-squared|||Response on Day 360||33.4|9.7|<0.001
73863689|NCT00162266|147273559|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.7||||0.625|TWO_SIDED|95.0|-8.1|13.5|||Chi-squared|||Response on Day 360||13.5|-8.1|0.625
73863690|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.5||||0.04||95.0|0.2|6.8|||Chi-squared|||Response on Day 30||6.8|0.2|0.04
73863691|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.9||||0.063|TWO_SIDED|95.0|-0.2|5.9|||Chi-squared|||Response on Day 30||5.9|-0.2|0.063
73863692|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.7||||0.001|TWO_SIDED|95.0|3.5|13.9|||Chi-squared|||Response on Day 60||13.9|3.5|0.001
73863693|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.8||||0.032|TWO_SIDED|95.0|0.3|7.3|||Chi-squared|||Response on Day 60||7.3|0.3|0.032
73863694|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|7.9||||0.005|TWO_SIDED|95.0|2.4|13.3|||Chi-squared|||Response on Day 90||13.3|2.4|0.005
73863695|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.9||||0.07|TWO_SIDED|95.0|-0.3|8.2|||Chi-squared|||Response on Day 90||8.2|-0.3|0.07
73863696|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|9.7||||0.007|TWO_SIDED|95.0|2.7|16.7|||Chi-squared|||Response on Day 120||16.7|2.7|0.007
73863697|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.4||||0.395||95.0|-3.1|7.8|||Chi-squared|||||7.8|-3.1|0.395
73863698|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|10.6||||0.004|TWO_SIDED|95.0|3.4|17.7|||Chi-squared|||Response on Day 150||17.7|3.4|0.004
73863699|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.4||||0.395|TWO_SIDED|95.0|-3.1|7.8|||Chi-squared|||Response on Day 150||7.8|-3.1|0.395
73863700|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|14.8|||<|0.001|TWO_SIDED|95.0|7.5|22.2|||Chi-squared|||Response on Day 180||22.2|7.5|<0.001
73932097|NCT03235024|147394422|EQUIVALENCE|A sample size of 52 per group would achieve \>80% power to reject the null hypothesis of equal means when the population mean difference is μ1 - μ2 = (-1.4) - (-5.3) = 3.9 with a standard deviation for both groups of 7.0 and with a significance level (alpha) of 0.025 using a 1-sided 2-sample equal variance t-test.||||||0.0228||||||At Week 2|t-test, 1 sided|||||||0.0228
73863701|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.8||||0.005|TWO_SIDED|95.0|2.7|14.9|||Chi-squared|||Response on Day 180||14.9|2.7|0.005
73863702|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|13.2||||0.002|TWO_SIDED|95.0|5.0|21.4|||Chi-squared|||Response on Day 240||21.4|5.0|0.002
73863703|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.5||||0.292|TWO_SIDED|95.0|-3.0|10.1|||Chi-squared|||Response on Day 240||10.1|-3.0|0.292
73863704|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.4|29.5|||Chi-squared|||Response on Day 300||29.5|12.4|<0.001
73863705|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.0||||0.014|TWO_SIDED|95.0|1.6|14.3|||Chi-squared|||Response on Day 300||14.3|1.6|0.014
73863706|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|13.3||||0.003|TWO_SIDED|95.0|4.4|22.2|||Chi-squared|||Response on Day 360||22.2|4.4|0.003
73863707|NCT00162266|147273560|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.8||||0.227|TWO_SIDED|95.0|-3.0|12.6|||Chi-squared|||Response on Day 360||12.6|-3.0|0.227
73863708|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.2676|TWO_SIDED|95.0|-1.56|5.61|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison||5.61|-1.56|0.2676
73863709|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.0418|TWO_SIDED|95.0|-7.46|-0.14|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison||-0.14|-7.46|0.0418
73863710|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.25||||0.0061|TWO_SIDED|95.0|2.08|12.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison||12.41|2.08|0.0061
73863711|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.6713|TWO_SIDED|95.0|-6.45|4.16||ANOVA model: AUC = treatment|ANOVA||Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison||4.16|-6.45|0.6713
73863712|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.75||||0.0002|TWO_SIDED|95.0|5.67|17.84|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison||17.84|5.67|0.0002
73863713|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.8495|TWO_SIDED|95.0|-5.62|6.82|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison||6.82|-5.62|0.8495
73863714|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1||||0.0003|TWO_SIDED|95.0|5.63|18.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison||18.56|5.63|0.0003
73863715|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.19||||0.0003|TWO_SIDED|95.0|-2.44|10.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison||10.81|-2.44|0.0003
73863716|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.54||||0.0001|TWO_SIDED|95.0|7.28|21.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison||21.81|7.28|0.0001
73863717|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.3141|TWO_SIDED|95.0|-3.43|10.64|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison||10.64|-3.43|0.3141
73932098|NCT00414050|147394429|NON_INFERIORITY_OR_EQUIVALENCE|Modified Process Hepatitis B vaccine-5µg (micrograms) declared non-inferior to RECOMBIVAX HB™ if the lower bound of the 95% Confidence Interval for the ratio of Geometric Mean Titers (Modified Process Vaccine 5 micrograms/RECOMBIVAX HB™) was \>= 0.67. The study had 98 percent power for this test, based on an assumption of true equality.|Ratio of geometric means|1.99|||||TWO_SIDED|95.0|1.69|2.35||||||Comparison of Induced (effected) Geometric Mean Titer for the Modified Hepatitis B Process Vaccine and RECOMBIVAX Hepatitis B vaccine.||2.35|1.69|
73863718|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.96||||0.0001|TWO_SIDED|95.0|8.49|25.43|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison||25.43|8.49|0.0001
73932099|NCT03304379|147394431|SUPERIORITY||Least Square (LS) Mean Difference|-0.63|||=|0.0003|TWO_SIDED|95.0|-0.971|-0.286||Threshold for significance at 0.05 level.|MMRM|||Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.||-0.286|-0.971|= 0.0003
73932100|NCT03304379|147394431|SUPERIORITY||LS Mean Difference|-0.77|||>|0.0001|TWO_SIDED|95.0|-1.154|-0.383||Threshold for significance at 0.05 level.|MMRM|||"(mFAS)~Analyses were based on a multiple imputation approach using a MMRM model with baseline, randomization strata, baseline, treatment, visit and treatment by-visit interaction"||-0.383|-1.154|> 0.0001
73932101|NCT03304379|147394432|SUPERIORITY||LS Mean Difference|-0.64|||=|0.0003|TWO_SIDED|95.0|-0.981|-0.29||Threshold for significance at 0.05 level.|MMRM|||Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.||-0.290|-0.981|= 0.0003
73932102|NCT03304379|147394432|SUPERIORITY||LS Mean Difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.198|-0.443||Threshold for significance at 0.05 level|MMRM|||"(mFAS)~Analyses were based on a multiple imputation approach using an Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction."||-0.443|-1.198|<0.0001
73971596|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|7.584||||0.8366|TWO_SIDED|95.0|-65.126|80.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||80.295|-65.126|0.8366
73932103|NCT03304379|147394433|SUPERIORITY||Odds Ratio (OR)|1.581|||=|0.0013|TWO_SIDED|95.0|1.195|2.092||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on Cochran-Mantel-Haenszel model.||2.092|1.195|= 0.0013
73932104|NCT03304379|147394434|SUPERIORITY||LS Mean Difference|-0.14|||=|0.0365|TWO_SIDED|95.0|-0.28|-0.009||Threshold for significance at 0.05 level.|MMRM|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on a multiple imputation approach using Mixed-Effect Model With Repeated Measure (MMRM) model.||-0.009|-0.28|= 0.0365
73932105|NCT03402243|147394449|SUPERIORITY||Estimated mean ratio|1.38|||||TWO_SIDED|95.0|1.1|1.75|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a total menthol ban smoked relative to those randomized to a menthol cigarette ban|||1.75|1.1|
73932106|NCT03402243|147394449|SUPERIORITY||Estimated mean ratio|0.87|||||TWO_SIDED|95.0|0.68|1.11|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a menthol cigarettes ban relative to those randomized to no menthol ban|||1.11|0.68|
73863719|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.32||||0.3552|TWO_SIDED|95.0|-3.73|10.37|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison||10.37|-3.73|0.3552
73932107|NCT03402243|147394449|SUPERIORITY||Estimated mean ratio|1.2|||||TWO_SIDED|95.0|0.99|1.45|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a menthol ban for cigarettes and e-cigarettes relative to those randomized to no menthol ban|||1.45|0.99|
73932108|NCT03402243|147394449|SUPERIORITY|||||||0.349|||||||Kruskal-Wallis|||Average number of puffs per participants over the 6 week study period||||0.349
73932109|NCT03402243|147394450|SUPERIORITY|||||||0.185|||||||Mixed Models Analysis|||Comparison among groups in number of cigarette packs selected||||0.185
74088689|NCT03465436|147730587|SUPERIORITY||LS Mean|103.64|||||TWO_SIDED|90.0|87.28|120.0|||Mixed Models Analysis|||2.5 hours postdose||120.00|87.28|
74088690|NCT03465436|147730587|SUPERIORITY||LS Mean|89.26|||||TWO_SIDED|90.0|71.24|107.29|||Mixed Models Analysis|||3 hours postdose||107.29|71.24|
73932110|NCT03402243|147394450|SUPERIORITY|||||||0.076|||||||Mixed Models Analysis|||Comparison among groups in number of e-cigarette liquid units selected||||0.076
73932111|NCT03402243|147394451|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
73932112|NCT00684424|147394458|SUPERIORITY_OR_OTHER_LEGACY||R-ratio|-56.723|STANDARD_DEVIATION|46.9499||||95.0|||||summary statistic|||R-ratio of seizure frequency summaries = \[(t-b)/(t+b)\]\*100; where t= treatment seizure frequency and b= baseline seizure frequency.||||
74088691|NCT03465436|147730587|SUPERIORITY||LS Mean|65.29|||||TWO_SIDED|90.0|48.28|82.3|||Mixed Models Analysis|||3.5 hours postdose||82.30|48.28|
73863720|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.36||||0.0001|TWO_SIDED|95.0|10.19|30.54|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison||30.54|10.19|0.0001
73932113|NCT00727857|147394468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|||<|0.0001||95.0|0.51|1.22|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way Analysis of Covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.||1.22|0.51|<0.0001
73971597|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-55.973||||0.5437|TWO_SIDED|95.0|-154.862|42.916|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||42.916|-154.862|0.5437
73971598|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-73.308||||0.2974|TWO_SIDED|95.0|-177.224|30.608|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||30.608|-177.224|0.2974
74008206|NCT03627767|147566486|SUPERIORITY||Difference in percentage|54.2|||<|0.0001|TWO_SIDED|95.0|47.3|61.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.0|47.3|< 0.0001
74008207|NCT03627767|147566486|SUPERIORITY||Difference in percentage|17.2|||||TWO_SIDED|95.0|8.9|25.5||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|8.9|
73932114|NCT00727857|147394468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|||<|0.0001||95.0|0.5|1.18|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.18|0.50|<0.0001
73932115|NCT00727857|147394468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8919||95.0|-0.37|0.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.33|-0.37|0.8919
73932116|NCT00727857|147394469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8||||0.0005||95.0|7.8|27.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||27.7|7.8|0.0005
73932117|NCT00727857|147394469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1||||0.0021||95.0|5.5|24.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||24.7|5.5|0.0021
73932118|NCT00727857|147394469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.5981||95.0|-12.5|7.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||7.2|-12.5|0.5981
73863721|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.38||||0.0451|TWO_SIDED|95.0|0.16|14.6|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison||14.60|0.16|0.0451
73932119|NCT00727857|147394470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.5074||95.0|-1.43|2.88|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.88|-1.43|0.5074
73932120|NCT00727857|147394470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.93||||0.0047||95.0|0.9|4.95|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.95|0.90|0.0047
73932121|NCT00727857|147394470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.0435||95.0|0.06|4.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.33|0.06|0.0435
73932122|NCT00727857|147394471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.629||||0.3158||95.0|-0.602|1.861|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.861|-0.602|0.3158
73971599|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-44.892||||0.9026|TWO_SIDED|95.0|-181.909|92.126|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||92.126|-181.909|0.9026
73971600|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-35.811||||0.8954|TWO_SIDED|95.0|-132.513|60.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||60.891|-132.513|0.8954
73971601|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-46.239||||0.7485|TWO_SIDED|95.0|-146.766|54.288|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||54.288|-146.766|0.7485
74008208|NCT03627767|147566486|SUPERIORITY||Difference in percentage|29.8|||<|0.0001|TWO_SIDED|95.0|22.7|37.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.0|22.7|< 0.0001
74008209|NCT03627767|147566486|SUPERIORITY||Difference in percentage|46.7|||<|0.0001|TWO_SIDED|95.0|39.6|53.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.8|39.6|< 0.0001
74030015|NCT01958671|147614124|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.39|-0.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.93|-1.39|<0.001
74030016|NCT01958671|147614125|SUPERIORITY_OR_OTHER||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-13.1|8.1|||||Based on Miettinen \& Nurminen method.|||8.1|-13.1|
74030017|NCT01958671|147614125|SUPERIORITY_OR_OTHER||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-14.8|6.6|||||Based on Miettinen \& Nurminen method.|||6.6|-14.8|
74030018|NCT01958671|147614126|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-7.7|3.3|||||Based on Miettinen \& Nurminen method.|||3.3|-7.7|
73863722|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.63||||0.0001|TWO_SIDED|95.0|8.83|26.44|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison||26.44|8.83|0.0001
74030019|NCT01958671|147614126|SUPERIORITY_OR_OTHER||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-8.2|2.7|||||Based on Miettinen \& Nurminen method.|||2.7|-8.2|
74030020|NCT01958671|147614127|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.53|||<|0.001|TWO_SIDED|95.0|-42.76|-26.29|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-26.29|-42.76|<0.001
74030021|NCT01958671|147614127|SUPERIORITY_OR_OTHER||Difference in least squares means|-44.01|||<|0.001|TWO_SIDED|95.0|-52.28|-35.74|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-35.74|-52.28|<0.001
73863723|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.78||||0.4669|TWO_SIDED|95.0|-4.73|10.28|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison||10.28|-4.73|0.4669
73863724|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.0||||0.0001|TWO_SIDED|95.0|10.51|31.48|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison||31.48|10.51|0.0001
73863725|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.13||||3.13|TWO_SIDED|95.0|-4.15|10.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison||10.41|-4.15|3.13
73863726|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.38||||0.0001|TWO_SIDED|95.0|10.2|30.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison||30.56|10.20|0.0001
73863727|NCT00162266|147273561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.06||||0.2989|TWO_SIDED|95.0|-3.61|11.72|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison||11.72|-3.61|0.2989
73863728|NCT00162266|147273562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2132.63||||0.0001|TWO_SIDED|95.0|1067.32|3197.94||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180||3197.94|1067.32|0.0001
73863729|NCT00162266|147273562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|353.47||||0.4393|TWO_SIDED|95.0|-544.46|1251.41||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180||1251.41|-544.46|0.4393
73971602|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-36.559||||0.9578|TWO_SIDED|95.0|-169.77|96.653|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||96.653|-169.770|0.9578
73971603|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.725||||0.3635|TWO_SIDED|95.0|-129.208|47.757|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||47.757|-129.208|0.3635
74008210|NCT03627767|147566486|SUPERIORITY||Difference in percentage|16.9|||||TWO_SIDED|95.0|8.5|25.3||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.3|8.5|
74008211|NCT03627767|147566486|SUPERIORITY||Difference in percentage|27.4|||<|0.0001|TWO_SIDED|95.0|20.4|34.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||34.3|20.4|< 0.0001
74030022|NCT01958671|147614128|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.76|||<|0.001|TWO_SIDED|95.0|-2.57|-0.95|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.95|-2.57|<0.001
74030023|NCT01958671|147614128|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.16|||<|0.001|TWO_SIDED|95.0|-2.98|-1.34|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-1.34|-2.98|<0.001
73863730|NCT00162266|147273562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5641.6||||0.0001|TWO_SIDED|95.0|2823.46|8459.74||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360||8459.74|2823.46|0.0001
73863731|NCT00162266|147273562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1054.38||||0.3029|TWO_SIDED|95.0|-955.59|3064.35||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360||3064.35|-955.59|0.3029
73863732|NCT00162266|147273566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.66||||0.0003|TWO_SIDED|95.0|12.67|42.66|||ANCOVA|ANCOVA: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180||42.66|12.67|0.0003
73863733|NCT00162266|147273566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.68||||0.3253|TWO_SIDED|95.0|||||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180||||0.3253
73863734|NCT00162266|147273566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.24||||0.0001|TWO_SIDED|95.0|16.14|48.33|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360||48.33|16.14|0.0001
73863735|NCT00162266|147273566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.48||||0.0869|TWO_SIDED|95.0|-1.82|26.78|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360||26.78|-1.82|0.0869
73932123|NCT00727857|147394471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.619||||0.0067||95.0|0.452|2.785|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.785|0.452|0.0067
74030024|NCT01958671|147614129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.001|TWO_SIDED|95.0|1.85|6.95|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline eGFR.||||6.95|1.85|<0.001
73863736|NCT02299076|147273625|SUPERIORITY|Welch Two Sample t-test|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73863737|NCT04268745|147273684|SUPERIORITY||Mean Difference (Final Values)|-13.603||||0.027|TWO_SIDED|95.0|-25.634|-1.573|||Regression, Linear|||||-1.573|-25.634|0.027
73932124|NCT00727857|147394471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.989||||0.1094||95.0|-0.223|2.201|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.201|-0.223|0.1094
73932125|NCT00727857|147394472|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.88||||0.5963||95.0|-4.71|13.97|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||13.97|-4.71|0.5963
73932126|NCT00727857|147394472|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12.81||||0.0265||95.0|2.88|22.24|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||22.24|2.88|0.0265
73932127|NCT00727857|147394472|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|8.33||||0.1053||95.0|-1.77|18.07|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||18.07|-1.77|0.1053
73932128|NCT00727857|147394473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.0806||95.0|-0.2|3.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.1|-0.2|0.0806
73932129|NCT00727857|147394473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-9.6|-6.5|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-6.5|-9.6|<0.0001
73932130|NCT00727857|147394473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||<|0.0001||95.0|-11.1|-7.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-7.9|-11.1|<0.0001
73932131|NCT00727857|147394474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.73||||0.0324||95.0|0.31|7.14|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||7.14|0.31|0.0324
73932132|NCT00727857|147394474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.78||||0.0233||95.0|-7.05|-0.52|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.52|-7.05|0.0233
73932133|NCT00727857|147394474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51|||<|0.0001||95.0|-10.9|-4.12|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-4.12|-10.90|<0.0001
73932134|NCT00727857|147394475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9||||0.0993||95.0|-0.93|10.72|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||10.72|-0.93|0.0993
73932135|NCT00727857|147394475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.367||95.0|-8.14|3.01|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.01|-8.14|0.3670
73932136|NCT00727857|147394475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.46||||0.0119||95.0|-13.26|-1.66|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-1.66|-13.26|0.0119
73932137|NCT00727857|147394476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.31||||0.0423||95.0|-8.48|-0.15|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.15|-8.48|0.0423
73932138|NCT00727857|147394476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-12.08|-4.12|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-4.12|-12.08|<0.0001
73932139|NCT00727857|147394476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.79||||0.728||95.0|-7.93|0.35|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.35|-7.93|0.728
74030025|NCT01958671|147614129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.77|||<|0.001|TWO_SIDED|95.0|3.46|13.24|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline||||13.24|3.46|<0.001
74088692|NCT03465436|147730587|SUPERIORITY||LS Mean|52.85|||||TWO_SIDED|90.0|36.1|69.6|||Mixed Models Analysis|||4 hours postdose||69.60|36.10|
73863738|NCT04268745|147273685|SUPERIORITY||Median Difference (Final Values)|6.405||||0.0001|TWO_SIDED|95.0|4.474|8.335|||Regression, Linear|||||8.335|4.474|0.0001
74030026|NCT01958671|147614131|SUPERIORITY_OR_OTHER||Difference in least squares means|-69.03|||<|0.001|TWO_SIDED|95.0|-83.24|-54.83|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-54.83|-83.24|<0.001
74030027|NCT01958671|147614131|SUPERIORITY_OR_OTHER||Difference in least squares means|-67.33|||<|0.001|TWO_SIDED|95.0|-81.73|-52.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-52.93|-81.73|<0.001
74030028|NCT01958671|147614133|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.31||||0.015|TWO_SIDED|95.0|-5.98|-0.65||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.65|-5.98|0.015
74030029|NCT01958671|147614133|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.71||||0.213|TWO_SIDED|95.0|-4.4|0.98|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||0.98|-4.40|0.213
74030030|NCT01958671|147614135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-1.8||||0.039|TWO_SIDED|95.0|-3.51|-0.09||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.09|-3.51|0.039
74030031|NCT01958671|147614135|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0.669|TWO_SIDED|95.0|-2.09|1.35||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||1.35|-2.09|0.669
74030032|NCT04760314|147614136|SUPERIORITY||Risk Difference (RD)|22.6|||<|0.001|TWO_SIDED|95.0|11.6|33.6|||Cochran-Mantel-Haenszel|||||33.6|11.6|<0.001
74030033|NCT04760314|147614136|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.001|TWO_SIDED|95.0|17.5|37.0|||Cochran-Mantel-Haenszel|||||37.0|17.5|<0.001
73863739|NCT04268745|147273686|SUPERIORITY||Mean Difference (Final Values)|-18.703||||0.0002|TWO_SIDED|95.0|-28.235|-9.172|||Regression, Linear|||||-9.172|-28.235|0.0002
73863740|NCT04268745|147273687|SUPERIORITY||Mean Difference (Final Values)|8.556||||0.028|TWO_SIDED|95.0|0.938|16.174|||Regression, Linear|||||16.174|0.938|0.028
73863741|NCT04268745|147273688|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.695|TWO_SIDED|95.0|-0.443|0.665|||Regression, Linear|||||0.665|-0.443|0.695
74030034|NCT04760314|147614137|SUPERIORITY||Risk Difference (RD)|33.2|||<|0.001|TWO_SIDED|95.0|20.6|45.8|||Cochran-Mantel-Haenszel|||||45.8|20.6|<0.001
74030035|NCT04760314|147614137|SUPERIORITY||Risk Difference (RD)|37.6|||<|0.001|TWO_SIDED|95.0|26.2|49.0|||Cochran-Mantel-Haenszel|||||49.0|26.2|<0.001
74030036|NCT04760314|147614138|SUPERIORITY||LS Mean Difference|-34.5|||<|0.001|TWO_SIDED|95.0|-44.1|-24.9|||ANCOVA|||||-24.9|-44.1|<0.001
74030037|NCT04760314|147614138|SUPERIORITY||LS Mean Difference|-38.99|||<|0.001|TWO_SIDED|95.0|-47.7|-30.3|||ANCOVA|||||-30.3|-47.7|<0.001
74030038|NCT04760314|147614139|SUPERIORITY||Risk Difference (RD)|18.4||||0.003|TWO_SIDED|95.0|6.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|6.8|0.003
74030039|NCT04760314|147614139|SUPERIORITY||Risk Difference (RD)|24.2|||<|0.001|TWO_SIDED|95.0|13.9|34.5|||Cochran-Mantel-Haenszel|||||34.5|13.9|<0.001
74030040|NCT04760314|147614140|SUPERIORITY||Risk Difference (RD)|1.2||||0.404|TWO_SIDED|95.0|-1.2|3.6|||Cochran-Mantel-Haenszel|||||3.6|-1.2|0.404
74030041|NCT04760314|147614141|SUPERIORITY||Risk Difference (RD)|1.8||||0.294|TWO_SIDED|95.0|-1.6|5.1|||Cochran-Mantel-Haenszel|||||5.1|-1.6|0.294
74030042|NCT04760314|147614141|SUPERIORITY||Risk Difference (RD)|3.7||||0.138|TWO_SIDED|95.0|-0.5|7.8|||Cochran-Mantel-Haenszel|||||7.8|-0.5|0.138
74030043|NCT04760314|147614142|SUPERIORITY||Risk Difference (RD)|9.2||||0.013|TWO_SIDED|95.0|1.8|16.5|||Cochran-Mantel-Haenszel|||||16.5|1.8|0.013
74030044|NCT04760314|147614142|SUPERIORITY||Risk Difference (RD)|16.2||||0.001|TWO_SIDED|95.0|8.1|24.3|||Cochran-Mantel-Haenszel|||||24.3|8.1|0.001
74030045|NCT04760314|147614143|SUPERIORITY||Risk Difference (RD)|20.6||||0.001|TWO_SIDED|95.0|8.7|32.4|||Cochran-Mantel-Haenszel|||||32.4|8.7|0.001
74030046|NCT04760314|147614143|SUPERIORITY||Risk Difference (RD)|29.2|||<|0.001|TWO_SIDED|95.0|17.9|40.4|||Cochran-Mantel-Haenszel|||||40.4|17.9|<0.001
74030047|NCT01290484|147614144|SUPERIORITY_OR_OTHER||Mean percentage volume change|-3.47||||||||||||||||||
74030048|NCT00960440|147614145|SUPERIORITY_OR_OTHER||Percentage Difference|23.69|STANDARD_ERROR_OF_MEAN|5.73|<|0.0001|TWO_SIDED|95.0|12.45|34.92||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||34.92|12.45|<0.0001
74030049|NCT00960440|147614145|SUPERIORITY_OR_OTHER||Percentage Difference|17.23|STANDARD_ERROR_OF_MEAN|5.7||0.0024|TWO_SIDED|95.0|6.06|28.41||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||28.41|6.06|0.0024
74030050|NCT00960440|147614146|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.38|-0.17||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.||-0.17|-0.38|<0.0001
74088693|NCT03465436|147730587|SUPERIORITY||LS Mean|86.09|||||TWO_SIDED|90.0|66.36|105.82|||Mixed Models Analysis|||6 hours postdose||105.82|66.36|
74088694|NCT03465436|147730587|SUPERIORITY||LS Mean|80.12|||||TWO_SIDED|90.0|58.32|101.91|||Mixed Models Analysis|||8 hours postdose||101.91|58.32|
74088695|NCT03465436|147730587|SUPERIORITY||LS Mean|67.58|||||TWO_SIDED|90.0|44.64|90.51|||Mixed Models Analysis|||12 hours postdose||90.51|44.64|
73932140|NCT00727857|147394477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.9231||95.0|-7.94|8.76|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||8.76|-7.94|0.9231
73932141|NCT00727857|147394477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.16||||0.3082||95.0|-3.86|12.19|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||12.19|-3.86|0.3082
73932142|NCT00727857|147394477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75||||0.3753||95.0|-4.56|12.07|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||12.07|-4.56|0.3753
73932143|NCT00727857|147394478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4||||0.4999||95.0|-44.6|91.4|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||91.4|-44.6|0.4999
73932144|NCT00727857|147394478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.2||||0.0531||95.0|-0.9|129.3|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||129.3|-0.9|0.0531
73932145|NCT00727857|147394478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.9||||0.2369||95.0|-26.9|108.7|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||108.7|-26.9|0.2369
73932146|NCT00727857|147394479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.5023||95.0|-0.09|0.19|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.19|-0.09|0.5023
73932147|NCT00727857|147394479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.0001||95.0|-0.48|-0.21|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.21|-0.48|<0.0001
73932148|NCT00727857|147394479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.0001||95.0|-0.53|-0.25|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.25|-0.53|<0.0001
73932149|NCT00727857|147394480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7||||0.2849||95.0|-16.5|55.9|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||55.9|-16.5|0.2849
73932150|NCT00727857|147394480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-77.6|||<|0.0001||95.0|-112.4|-42.8|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-42.8|-112.4|<0.0001
73932151|NCT00727857|147394480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-97.3|||<|0.0001||95.0|-133.4|-61.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-61.2|-133.4|<0.0001
74088696|NCT03465436|147730587|SUPERIORITY||LS Mean|7.77|||||TWO_SIDED|90.0|-10.01|25.55|||Mixed Models Analysis|||24 hours postdose||25.55|-10.01|
73932152|NCT00727857|147394481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.2894||95.0|-4.5|15.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||15.1|-4.5|0.2894
73932153|NCT00727857|147394481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8463||95.0|-10.3|8.5|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||8.5|-10.3|0.8463
73932154|NCT00727857|147394481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.2124||95.0|-16.0|3.6|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.6|-16.0|0.2124
73932155|NCT00727857|147394482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.804||95.0|-19.4|15.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||15.0|-19.4|0.8040
73932156|NCT00727857|147394482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5||||0.0008||95.0|12.0|45.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||45.0|12.0|0.0008
74008212|NCT03627767|147566486|SUPERIORITY||Difference in percentage|43.8|||<|0.0001|TWO_SIDED|95.0|36.7|50.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.9|36.7|< 0.0001
74008213|NCT03627767|147566486|SUPERIORITY||Difference in percentage|16.8|||||TWO_SIDED|95.0|8.4|25.2||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.2|8.4|
74088697|NCT03465436|147730587|SUPERIORITY||LS Mean|-22.02|||||TWO_SIDED|90.0|-38.44|-5.6|||Mixed Models Analysis|||30 minutes postdose||-5.60|-38.44|
74088698|NCT03465436|147730587|SUPERIORITY||LS Mean|-38.87|||||TWO_SIDED|90.0|-57.15|-20.6|||Mixed Models Analysis|||1 hour postdose||-20.60|-57.15|
74088699|NCT03465436|147730587|SUPERIORITY||LS Mean|-22.13|||||TWO_SIDED|90.0|-39.35|-4.91|||Mixed Models Analysis|||1.5 hours postdose||-4.91|-39.35|
74088700|NCT03465436|147730587|SUPERIORITY||LS Mean|-17.35|||||TWO_SIDED|90.0|-32.15|-2.56|||Mixed Models Analysis|||2 hours postdose||-2.56|-32.15|
73971604|NCT04800211|147483698|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-8.333||||0.8713|TWO_SIDED|95.0|-110.097|93.431|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||93.431|-110.097|0.8713
73971605|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-115.256||||0.0003|TWO_SIDED|95.0|-177.973|-52.539|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-52.539|-177.973|0.0003
73971606|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-74.904||||0.0467|TWO_SIDED|95.0|-148.706|-1.102|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-1.102|-148.706|0.0467
73971607|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-144.035|||<|0.0001|TWO_SIDED|95.0|-206.668|-81.402|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-81.402|-206.668|<.0001
73971608|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-62.755||||0.0807|TWO_SIDED|95.0|-133.221|7.71|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||7.710|-133.221|0.0807
73971609|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-68.83||||0.0095|TWO_SIDED|95.0|-120.753|-16.907|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-16.907|-120.753|0.0095
74030051|NCT00960440|147614146|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.36|-0.15||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.||-0.15|-0.36|<0.0001
74088701|NCT03465436|147730587|SUPERIORITY||LS Mean|-1.03|||||TWO_SIDED|90.0|-18.17|16.12|||Mixed Models Analysis|||2.5 hours postdose||16.12|-18.17|
74088702|NCT03465436|147730587|SUPERIORITY||LS Mean|-4.77|||||TWO_SIDED|90.0|-21.81|12.27|||Mixed Models Analysis|||3 hours postdose||12.27|-21.81|
73932157|NCT00727857|147394482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.6||||0.0005||95.0|13.4|47.8|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||47.8|13.4|0.0005
73932158|NCT00727857|147394483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.9604||95.0|-83.3|79.2|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||79.2|-83.3|0.9604
73932159|NCT00727857|147394483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|140.3||||0.0004||95.0|62.5|218.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||218.0|62.5|0.0004
73932160|NCT00727857|147394483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.3||||0.0006||95.0|61.3|223.3|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||223.3|61.3|0.0006
73932161|NCT00727857|147394484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.9922||95.0|-64.4|65.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||65.1|-64.4|0.9922
73932162|NCT00727857|147394484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|111.7||||0.0004||95.0|49.7|173.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||173.7|49.7|0.0004
73971610|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-1.593||||0.9586|TWO_SIDED|95.0|-61.873|58.687|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||58.687|-61.873|0.9586
73971611|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.635||||0.9402|TWO_SIDED|95.0|-71.714|66.443|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||66.443|-71.714|0.9402
73971612|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-113.663||||0.039|TWO_SIDED|95.0|-223.33|-3.996|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-3.996|-223.330|0.0390
73971613|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-72.269||||0.4543|TWO_SIDED|95.0|-199.091|54.554|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||54.554|-199.091|0.4543
74039397|NCT04847141|147632409|SUPERIORITY||Difference in Percentage|4.4||||0.392|TWO_SIDED|95.0|-5.8|14.7||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 3||14.7|-5.8|0.3920
73932163|NCT00727857|147394484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|111.4||||0.0008||95.0|46.8|175.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||175.9|46.8|0.0008
73932164|NCT00727857|147394485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0072||95.0|-1.86|-0.29|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.29|-1.86|0.0072
73932165|NCT00727857|147394485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.3682||95.0|-0.41|1.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.10|-0.41|0.3682
73932166|NCT00727857|147394485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42||||0.0004||95.0|0.64|2.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.20|0.64|0.0004
73932167|NCT00727857|147394486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1986||95.0|-0.02|0.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.10|-0.02|0.1986
73932168|NCT00727857|147394486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.1487||95.0|-0.1|0.02|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.02|-0.10|0.1487
73932169|NCT00727857|147394486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.0076||95.0|-0.14|-0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.02|-0.14|0.0076
73932170|NCT00727857|147394487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.2384||95.0|-0.21|0.83|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.83|-0.21|0.2384
73932171|NCT00727857|147394487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4617||95.0|-0.69|0.31|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.31|-0.69|0.4617
73932172|NCT00727857|147394487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0593||95.0|-1.02|0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.02|-1.02|0.0593
73932173|NCT00727857|147394488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.5044||95.0|-0.54|1.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.10|-0.54|0.5044
73932174|NCT00727857|147394488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43||||0.0004||95.0|-2.22|-0.64|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.64|-2.22|0.0004
73932175|NCT00727857|147394488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|||<|0.0001||95.0|-2.53|-0.89|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.89|-2.53|<0.0001
73932176|NCT00727857|147394489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0017||95.0|-2.64|-0.62|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.62|-2.64|0.0017
73971614|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-142.442||||0.0051|TWO_SIDED|95.0|-252.08|-32.805|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-32.805|-252.080|0.0051
73932177|NCT00727857|147394489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||<|0.0001||95.0|1.01|2.94|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.94|1.01|<0.0001
73932178|NCT00727857|147394489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|||<|0.0001||95.0|2.59|4.61|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.61|2.59|<0.0001
73932179|NCT00727857|147394490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.76||||0.2466||95.0|-2.61|10.14|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||10.14|-2.61|0.2466
73932180|NCT00727857|147394490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.52||||0.0063||95.0|-14.63|-2.42|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-2.42|-14.63|0.0063
74039398|NCT04847141|147632409|SUPERIORITY||Difference in Percentage|1.7||||0.7632|TWO_SIDED|95.0|-9.5|12.9||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 7||12.9|-9.5|0.7632
73932181|NCT00727857|147394490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.29||||0.0002||95.0|-18.65|-5.93|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-5.93|-18.65|0.0002
73971615|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-60.12||||0.6061|TWO_SIDED|95.0|-184.286|64.046|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||64.046|-184.286|0.6061
73971616|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-66.194||||0.1242|TWO_SIDED|95.0|-150.672|18.284|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||18.284|-150.672|0.1242
74008214|NCT03627767|147566487|SUPERIORITY||Difference in percentage|0.3|||=|0.9313|TWO_SIDED|95.0|-7.5|8.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.1|-7.5|= 0.9313
74008215|NCT03627767|147566487|SUPERIORITY||Difference in percentage|-2.1|||=|0.6043|TWO_SIDED|95.0|-9.8|5.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.7|-9.8|= 0.6043
73863742|NCT04268745|147273689|SUPERIORITY||Mean Difference (Final Values)|-0.514||||0.469|TWO_SIDED|95.0|-1.901|0.874|||Regression, Linear|||||0.874|-1.901|0.469
73863743|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.33|0.75|
73863744|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.24|1.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.94|1.24|
73863745|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.74|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.41|0.74|
73863746|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|1.01|2.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.00|1.01|
73863747|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.18|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.51|1.18|
73863748|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.07|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.47|1.07|
73863749|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||TWO_SIDED|95.0|0.79|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.12|0.79|
73971617|NCT04800211|147483699|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-12.149||||0.8117|TWO_SIDED|95.0|-112.35|88.052|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||88.052|-112.350|0.8117
73971618|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-111.957||||0.0567|TWO_SIDED|95.0|-227.151|3.237|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.237|-227.151|0.0567
74030052|NCT00960440|147614147|SUPERIORITY_OR_OTHER||Percentage Difference|9.53|STANDARD_ERROR_OF_MEAN|3.05||0.0017|TWO_SIDED|95.0|3.54|15.51||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||15.51|3.54|0.0017
73932182|NCT00727857|147394491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.2069||95.0|-2.93|0.64|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.64|-2.93|0.2069
73932183|NCT00727857|147394491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.0052||95.0|0.73|4.15|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.15|0.73|0.0052
73932184|NCT00727857|147394491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.59|||<|0.0001||95.0|1.81|5.36|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||5.36|1.81|<0.0001
73932185|NCT00727857|147394492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.609||95.0|-1.28|0.75|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.75|-1.28|0.6090
73932186|NCT00727857|147394492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.6169||95.0|-1.22|0.72|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.72|-1.22|0.6169
73932187|NCT00727857|147394492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.974||95.0|-0.99|1.03|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.03|-0.99|0.9740
74088703|NCT03465436|147730587|SUPERIORITY||LS Mean|-16.56|||||TWO_SIDED|90.0|-33.36|0.24|||Mixed Models Analysis|||3.5 hours postdose||0.24|-33.36|
73932188|NCT00727857|147394493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.615||95.0|-3.09|5.21|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||5.21|-3.09|0.6150
73932189|NCT00727857|147394493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.2346||95.0|-6.38|1.57|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.57|-6.38|0.2346
73932190|NCT00727857|147394493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.1001||95.0|-7.61|0.67|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.67|-7.61|0.1001
73932191|NCT00727857|147394494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86||||0.1217||95.0|-0.76|6.48|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||6.48|-0.76|0.1217
73932192|NCT00727857|147394494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.0009||95.0|-9.36|-2.44|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-2.44|-9.36|0.0009
73932193|NCT00727857|147394494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.76|||<|0.0001||95.0|-12.36|-5.16|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-5.16|-12.36|<0.0001
73932194|NCT00835406|147394501|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA will be performed on ln-transformed Ae0-36 and Rmax at the α level of 0.05.|Ratio of the mean|97.94||||||90.0|90.96|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.45|90.96|
73932195|NCT00835406|147394502|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA will be performed on ln-transformed Ae0-35 and Rmax at the α level of 0.05.|Ratio of the mean|100.36||||||90.0|92.85|108.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.48|92.85|
73932196|NCT02550652|147394503|SUPERIORITY||Difference in Percentage of Participants|12.3||||0.1145|TWO_SIDED|95.0|-3.4|28.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||28.1|-3.4|0.1145
73932197|NCT02550652|147394503|SUPERIORITY||Difference in Percentage of Participants|12.3||||0.1145|TWO_SIDED|80.0|2.1|22.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|Difference in Percentage of Participants||||22.6|2.1|0.1145
73932198|NCT02550652|147394504|SUPERIORITY||Difference in Percentage of Participants|20.1||||0.0246||95.0|3.0|37.2||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||37.2|3.0|0.0246
73932199|NCT02550652|147394504|SUPERIORITY||Difference in Percentage of Participants|20.1||||0.0246|TWO_SIDED|80.0|8.9|31.3||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||31.3|8.9|0.0246
73932200|NCT02550652|147394505|SUPERIORITY|||||||0.0744|||||||Log Rank|||||||0.0744
73971619|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-76.728||||0.2103|TWO_SIDED|95.0|-197.025|43.569|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||43.569|-197.025|0.2103
74008216|NCT03627767|147566487|SUPERIORITY||Difference in percentage|-2.3|||||TWO_SIDED|95.0|-10.0|5.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.4|-10.0|
74008217|NCT03627767|147566487|SUPERIORITY||Difference in percentage|11.6|||<|0.0001|TWO_SIDED|95.0|6.6|16.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||16.5|6.6|< 0.0001
73932201|NCT02550652|147394506|SUPERIORITY||Difference in Percentage of Participants|21.7||||0.015||95.0|4.7|38.7||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||38.7|4.7|0.0150
74030053|NCT00960440|147614147|SUPERIORITY_OR_OTHER||Percentage Difference|5.05|STANDARD_ERROR_OF_MEAN|2.57||0.0496|TWO_SIDED|95.0|0.0|10.1||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||10.10|0.00|0.0496
73932202|NCT02550652|147394506|SUPERIORITY||Difference in Percentage of Participants|21.7||||0.015|TWO_SIDED|80.0|10.6|32.8||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||32.8|10.6|0.0150
73932203|NCT02550652|147394507|SUPERIORITY||Difference in Percentage of Participants|-2.0||||0.8461|TWO_SIDED|95.0|-17.5|13.4||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||13.4|-17.5|0.8461
73932204|NCT02550652|147394507|SUPERIORITY||Difference in Percentage of Participants|-2.0||||0.8461|TWO_SIDED|80.0|-12.1|8.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||8.1|-12.1|0.8461
73932205|NCT02550652|147394508|SUPERIORITY|||||||0.353|||||||Log Rank|||||||0.3530
73932206|NCT02550652|147394509|SUPERIORITY||Difference in Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.491||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||-0.491|-1.13|<0.0001
73932207|NCT02550652|147394509|SUPERIORITY||Difference in Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|80.0|-1.019|-0.602||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||-0.602|-1.019|<0.0001
73932208|NCT02550652|147394510|SUPERIORITY||Difference in Adjusted Mean|0.178||||0.0004|TWO_SIDED|95.0|0.081|0.275||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||0.275|0.081|0.0004
73932209|NCT02550652|147394510|SUPERIORITY||Difference in Adjusted Mean|0.178||||0.0004|TWO_SIDED|80.0|0.115|0.241|||ANCOVA|||||0.241|0.115|0.0004
73932210|NCT02550652|147394511|SUPERIORITY||Difference in Adjusted Mean|0.088|||<|0.0001||95.0|0.052|0.124|||ANCOVA|Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).||||0.124|0.052|<0.0001
73932211|NCT02550652|147394511|SUPERIORITY||Difference in Adjusted Mean|0.088|||<|0.0001|TWO_SIDED|80.0|0.065|0.112||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||0.112|0.065|<0.0001
73863750|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||TWO_SIDED|95.0|0.58|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.25|0.58|
73863751|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||TWO_SIDED|95.0|0.94|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.93|0.94|
73863752|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||TWO_SIDED|95.0|0.96|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.61|0.96|
73863753|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.09|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.12|1.09|
73863754|NCT00574548|147273702|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.8|||||TWO_SIDED|95.0|1.86|4.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||4.35|1.86|
73863755|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.43|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.57|1.43|
73863756|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.95|3.16|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.16|1.95|
73863757|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.12|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.96|1.12|
73971620|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-169.735||||0.0052|TWO_SIDED|95.0|-288.22|-51.251|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-51.251|-288.220|0.0052
74008218|NCT03627767|147566487|SUPERIORITY||Difference in percentage|25.3|||<|0.0001|TWO_SIDED|95.0|19.4|31.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.2|19.4|< 0.0001
74008219|NCT03627767|147566487|SUPERIORITY||Difference in percentage|13.5|||||TWO_SIDED|95.0|6.6|20.4||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.4|6.6|
74030054|NCT02345161|147614206|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|0.171|STANDARD_ERROR_OF_MEAN|0.0118|<|0.001|TWO_SIDED|95.0|0.148|0.194|||Mixed Model Repeated Measures|||||0.194|0.148|<0.001
73863758|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.4|||||TWO_SIDED|95.0|1.67|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.31|1.67|
73863759|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.19|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.47|1.19|
74008220|NCT03627767|147566487|SUPERIORITY||Difference in percentage|12.9|||<|0.0001|TWO_SIDED|95.0|7.7|18.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||18.0|7.7|< 0.0001
73863760|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|4.3|||||TWO_SIDED|95.0|2.76|6.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||6.61|2.76|
73863761|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|3.3|||||TWO_SIDED|95.0|1.97|5.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||5.45|1.97|
73863762|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|0.98|2.1|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.10|0.98|
73863763|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.32|2.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.69|1.32|
73863764|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.27|2.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.07|1.27|
73863765|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.96|3.74|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.74|1.96|
73863766|NCT00574548|147273703|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.05|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.45|1.05|
73863767|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.54|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.82|0.54|
74030055|NCT02345161|147614207|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|0.179|STANDARD_ERROR_OF_MEAN|0.0242|<|0.001|TWO_SIDED|95.0|0.131|0.226|||Mixed Model Repeated Measures|||||0.226|0.131|<0.001
74030056|NCT02345161|147614208|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-3.5|-1.0|||Mixed Model Repeated Measures|||||-1.0|-3.5|<0.001
74030057|NCT02345161|147614209|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|1.44||0.065|TWO_SIDED|95.0|-5.5|0.2|||Mixed Model Repeated Measures|||||0.2|-5.5|0.065
74030058|NCT02345161|147614210|SUPERIORITY_OR_OTHER||LS Mean difference|0.57|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|0.3|0.84|||Mixed effect repeated measures model|||||0.84|0.30|<0.001
73932212|NCT02550652|147394512|SUPERIORITY||Difference in Percentage of Participants|13.9||||0.09||95.0|-2.4|30.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||30.1|-2.4|0.0900
73932213|NCT02550652|147394512|SUPERIORITY||Difference in Percentage of Participants|13.9||||0.09|TWO_SIDED|80.0|3.2|24.5||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||24.5|3.2|0.0900
73932214|NCT02550652|147394513|SUPERIORITY||Difference in Percentage of Participants|10.6||||0.1838|TWO_SIDED|95.0|-6.4|27.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||27.6|-6.4|0.1838
73932215|NCT02550652|147394513|SUPERIORITY||Difference in Percentage of Participants|10.6||||0.1838|TWO_SIDED|80.0|-0.5|21.7||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||21.7|-0.5|0.1838
73932216|NCT02550652|147394514|SUPERIORITY||Difference in Percentage of Participants|7.3||||0.3726|TWO_SIDED|95.0|-10.0|24.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||24.6|-10.0|0.3726
73863768|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|0.99|1.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.49|0.99|
73932217|NCT02550652|147394514|SUPERIORITY||Difference in Percentage of Participants|7.3||||0.3726|TWO_SIDED|80.0|-4.0|18.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||18.6|-4.0|0.3726
73932218|NCT01706250|147394525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.29|STANDARD_DEVIATION|32.98||0.6779|||||||t-test, 2 sided|||Percent change for IL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.6779
73932219|NCT01706250|147394525|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.68|STANDARD_DEVIATION|29.51||0.2847|||||||t-test, 2 sided|||Percent change for NIL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.2847
73932220|NCT01706250|147394525|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.24|STANDARD_DEVIATION|23.35||0.6894|||||||t-test, 2 sided|||Percent change for TL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.6894
73932221|NCT01706250|147394526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.38|STANDARD_DEVIATION|50.1||0.9909|||||||Signed Rank|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 1 (within group)||||0.9909
73932222|NCT01706250|147394526|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0|STANDARD_DEVIATION|39.91||0.6671|||||||t-test, 2 sided|||IL count for MAXCLARITY II Vs PROACTIV- BL to Wk 2 (within group)||||0.6671
73932223|NCT01706250|147394526|SUPERIORITY_OR_OTHER||Median Difference (Net)|23.64|STANDARD_DEVIATION|52.05||0.0632|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 4 (within group)||||0.0632
74030059|NCT02345161|147614211|SUPERIORITY_OR_OTHER||LS Mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.317||0.279|TWO_SIDED|95.0|-0.28|0.97|||Mixed effect repeated measures model|||||0.97|-0.28|0.279
73932224|NCT01706250|147394527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|42.31||0.7385|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 1 (within group)||||0.7385
73932225|NCT01706250|147394527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.04|STANDARD_DEVIATION|37.77||0.7296|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 2 (within group)||||0.7296
73932226|NCT01706250|147394527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|STANDARD_DEVIATION|36.11||0.3774|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 4 (within group)||||0.3774
74030060|NCT02345161|147614212|SUPERIORITY_OR_OTHER||LS Mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.817|TWO_SIDED|95.0|-0.9|1.1|||ANCOVA|||||1.1|-0.9|0.817
73932227|NCT01706250|147394528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02|STANDARD_DEVIATION|29.53||0.7634|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 1 (within group)||||0.7634
73932228|NCT01706250|147394528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.75|STANDARD_DEVIATION|29.61||0.4087|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 2 (within group)||||0.4087
73932229|NCT01706250|147394528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_DEVIATION|25.4||0.2455|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 4 (within group)||||0.2455
73932230|NCT01706250|147394529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.39||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
73932231|NCT01706250|147394529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_DEVIATION|0.56||0.125|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.1250
73932232|NCT01706250|147394529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_DEVIATION|0.46||0.625|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.6250
73932233|NCT01706250|147394529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.59||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||1.0000
73932234|NCT01706250|147394530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.45||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
74030061|NCT02345161|147614213|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.767|TWO_SIDED|95.0|-2.1|1.6|||ANCOVA|||||1.6|-2.1|0.767
73932235|NCT01706250|147394530|SUPERIORITY_OR_OTHER||Signed Rank|0.05|STANDARD_DEVIATION|0.23||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||1.0000
73932236|NCT01706250|147394531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.22||1|||||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.00
73932237|NCT01706250|147394531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.23||1|||||||Signed rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||1.0000
73932238|NCT01706250|147394532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_DEVIATION|0.46||1|||||||Signed rank|||Change, in Peeling, for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||1.0000
73932239|NCT01706250|147394533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_DEVIATION|0.67||0.5313||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.5313
73932240|NCT01706250|147394533|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.16|STANDARD_DEVIATION|0.6||0.5||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.5000
73971621|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-52.505||||0.349|TWO_SIDED|95.0|-162.721|57.711|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||57.711|-162.721|0.3490
74030062|NCT02345161|147614214|SUPERIORITY_OR_OTHER||Rate ratio|0.65||||0.002|TWO_SIDED|95.0|0.49|0.86|||Generalized linear modeL|Generalized linear model assuming a negative binomial distribution||||0.86|0.49|0.002
74030063|NCT02345161|147614215|SUPERIORITY_OR_OTHER||Rate ratio|0.56||||0.006|TWO_SIDED|95.0|0.37|0.85|||Generalized Linear model|Generalized linear model assuming a negative binomial distribution||||0.85|0.37|0.006
74030064|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.25|-0.66|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4|||-0.66|-1.25|<0.001
74030065|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.183|<|0.001|TWO_SIDED|95.0|-1.59|-0.87|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8|||-0.87|-1.59|<0.001
73932241|NCT01706250|147394533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.86||0.75|||||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.7500
73932242|NCT01706250|147394533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.84||0.25|||||||Signed rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.2500
73932243|NCT01706250|147394534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.86||0.2131|||||||Signed Rank)|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.2131
73932244|NCT01706250|147394534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_DEVIATION|1.16||0.2656||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.2656
73932245|NCT01706250|147394534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.75||0.2344||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.2344
73932246|NCT01706250|147394534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.73||0.3594||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.3594
74030066|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.201|<|0.001|TWO_SIDED|95.0|-1.57|-0.78|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12|||-0.78|-1.57|<0.001
74030067|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-1.33|STANDARD_ERROR_OF_MEAN|0.213|<|0.001|TWO_SIDED|95.0|-1.75|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16|||-0.91|-1.75|<0.001
73932247|NCT01706250|147394535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.32||0.6172|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.6172
73932248|NCT01706250|147394535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26|STANDARD_DEVIATION|0.93||0.3984|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.3984
73932249|NCT01706250|147394535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_DEVIATION|1.1||0.0781||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.0781
73932250|NCT01706250|147394535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.24||0.375||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.3750
73932251|NCT01706250|147394536|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|STANDARD_DEVIATION|0.46||1||95.0|||||[Signed Rank]|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
73932252|NCT01706250|147394536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_DEVIATION|0.58||0.0625||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.0625
73932253|NCT01706250|147394536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.75||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.2500
74030068|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.223|<|0.001|TWO_SIDED|95.0|-1.85|-0.97|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20|||-0.97|-1.85|<0.001
74030069|NCT02345161|147614216|SUPERIORITY_OR_OTHER||Mixed Model Repeated Measures|-1.35|STANDARD_ERROR_OF_MEAN|0.224|<|0.001|TWO_SIDED|95.0|-1.79|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 21-24|||-0.91|-1.79|<0.001
73932254|NCT01706250|147394536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.38||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.2500
73932255|NCT01706250|147394537|SUPERIORITY_OR_OTHER||Signed Rank|0.15|STANDARD_DEVIATION|0.59||0.5||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.5000
73932256|NCT01706250|147394537|SUPERIORITY_OR_OTHER||Signed Rank|0.11|STANDARD_DEVIATION|0.57||0.75||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.7500
73932257|NCT01706250|147394537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.62||0.4531||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.4531
73932258|NCT01706250|147394537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.86||0.625||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.6250
73932259|NCT02486406|147394550|SUPERIORITY||Wilson's score method|98.4|||||TWO_SIDED|95.0|91.7|99.7||||||According to the Highlights of Prescribing Information of PEGASYS, the SVR24 rate was 47% among 45 treatment-naïve pediatric participants with HCV GT1 in the NV17424 trial. To show that the DAA regimen is superior to this current standard of care by 20%, the lower bound of the 2-sided 95% confidence interval of the SVR12 rate across all participants in the study must be greater than 67%.||99.7|91.7|
73932260|NCT00799617|147394579|SUPERIORITY||Mean Difference (Net)|0.58|||<|0.001|TWO_SIDED|95.0|0.38|0.78||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||0.78|0.38|<0.001
73932261|NCT00799617|147394580|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2|TWO_SIDED|95.0|0.83|2.45||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||The treatment effect for dichotomous outcomes is the odds ratio for achieving the outcome versus not achieving the outcome among men assigned to testosterone versus those assigned to placebo.||2.45|0.83|0.20
74030070|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.67|-0.36|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 1-4|||-0.36|-0.67|<0.001
74030071|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.88|-0.5|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 5-8|||-0.50|-0.88|<0.001
74030072|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.108|<|0.001|TWO_SIDED|95.0|-0.9|-0.48|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 9-12|||-0.48|-0.90|<0.001
74030073|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.115|<|0.001|TWO_SIDED|95.0|-0.97|-0.52|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 13-16|||-0.52|-0.97|<0.001
74030074|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-1.03|-0.56|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 17-20|||-0.56|-1.03|<0.001
74030075|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-1.01|-0.54|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 21-24|||-0.54|-1.01|<0.001
73932262|NCT00799617|147394581|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3|TWO_SIDED|95.0|0.83|1.84||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||1.84|0.83|0.30
73932263|NCT00799617|147394582|SUPERIORITY||Mean Difference (Final Values)|41.0||||0.003|TWO_SIDED|95.0|14.0|67.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||67|14|.003
73932264|NCT00799617|147394583|SUPERIORITY||Mean Difference (Final Values)|6.8|||<|0.001|TWO_SIDED|95.0|4.8|8.7||Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.|Regression, Linear|||||8.7|4.8|<.001
73957783|NCT00383188|147451052|SUPERIORITY||LSM Difference|-1.017|STANDARD_ERROR_OF_MEAN|0.409||0.0131|TWO_SIDED|95.0|-1.82|-0.214|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.214|-1.820|0.0131
73957784|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.492|STANDARD_ERROR_OF_MEAN|0.424||0.2459|TWO_SIDED|95.0|-1.324|0.34|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.340|-1.324|0.2459
73957785|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.221|STANDARD_ERROR_OF_MEAN|0.356||0.536|TWO_SIDED|95.0|-0.921|0.479|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.479|-0.921|0.5360
73957786|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.465|STANDARD_ERROR_OF_MEAN|0.351||0.1858|TWO_SIDED|95.0|-1.155|0.225|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.225|-1.155|0.1858
73957787|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.821|STANDARD_ERROR_OF_MEAN|0.409||0.0451|TWO_SIDED|95.0|-1.624|-0.018|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.018|-1.624|0.0451
73932265|NCT00799617|147394584|SUPERIORITY||Mean Difference (Net)|-0.07||||0.88|TWO_SIDED|95.0|-0.92|0.79||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis|||"A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.~The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors."||0.79|-0.92|.88
73932266|NCT00799617|147394585|SUPERIORITY|Dichotomous hemoglobin response is an increase of 1g/dL or more from baseline.|Odds Ratio (OR)|31.5||||0.002|TWO_SIDED|95.0|3.7|277.8||The P-value for the significance of the treatment effect was determined by a logistic mixed model with a random intercept for participant.|Mixed Models Analysis|The statistical analysis was intent-to-treat by a logistic mixed effects model adjusted for balancing factors.||||277.8|3.7|.002
73932267|NCT00799617|147394586|SUPERIORITY||Mean Difference (Net)|2.93|||<|0.001|TWO_SIDED|95.0|2.13|3.74||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||3.74|2.13|<0.001
73971622|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-11.413||||0.841|TWO_SIDED|95.0|-123.333|100.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||100.507|-123.333|0.8410
73932268|NCT00799617|147394587|SUPERIORITY||Median Difference (Net)|2.64|||<|0.001|TWO_SIDED|95.0|1.68|3.61||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||3.61|1.68|<0.001
73932269|NCT00799617|147394588|SUPERIORITY||Mean Difference (Final Values)|4.09||||0.28|TWO_SIDED|95.0|-3.0|11.18||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||11.18|-3.00|0.28
73932270|NCT00799617|147394589|SUPERIORITY||Odds Ratio (OR)|1.34||||0.15|TWO_SIDED|95.0|0.9|2.0||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||2.00|0.90|0.15
73932271|NCT00799617|147394590|SUPERIORITY||Mean Difference (Net)|2.75||||0.03|TWO_SIDED|95.0|0.2|5.29||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||5.29|0.20|0.03
73932272|NCT00799617|147394591|SUPERIORITY||Mean Difference (Net)|1.21||||0.06|TWO_SIDED|95.0|-0.04|2.46||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||2.46|-0.04|0.06
74030076|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|-0.26|-0.09|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 1-4|||-0.09|-0.26|<0.001
74030077|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|95.0|-0.31|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 5-8|||-0.10|-0.31|<0.001
73932273|NCT00799617|147394592|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.41||||0.03|TWO_SIDED|95.0|0.31|4.5||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||4.50|0.31|0.03
74030078|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.058||0.004|TWO_SIDED|95.0|-0.28|-0.05|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 9-12|||-0.05|-0.28|0.004
74030079|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.061|<|0.001|TWO_SIDED|95.0|-0.34|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 13-16|||-0.10|-0.34|<0.001
74030080|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.064|<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 17-20|||-0.11|-0.36|<0.001
74030081|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.35|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 21-24|||-0.10|-0.35|<0.001
74030082|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.049|<|0.001|TWO_SIDED|95.0|-0.37|-0.18|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 1-4|||-0.18|-0.37|<0.001
74030083|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.46|-0.23|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 5-8|||-0.23|-0.46|<0.001
73932274|NCT00799617|147394593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.04|TWO_SIDED|95.0|0.02|0.92||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||0.92|0.02|0.04
73971623|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-53.565||||0.3465|TWO_SIDED|95.0|-165.4|58.27|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||58.270|-165.400|0.3465
73971624|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-111.65||||0.0087|TWO_SIDED|95.0|-194.865|-28.435|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-28.435|-194.865|0.0087
73971625|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|63.944||||0.2688|TWO_SIDED|95.0|-49.678|177.565|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||177.565|-49.678|0.2688
73971626|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|151.222||||0.0096|TWO_SIDED|95.0|37.114|265.33|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||265.330|37.114|0.0096
74030084|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.066|<|0.001|TWO_SIDED|95.0|-0.47|-0.21|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 9-12|||-0.21|-0.47|<0.001
74030085|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|95.0|-0.51|-0.25|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 13-16|||-0.25|-0.51|<0.001
74030086|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.53|-0.26|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 17-20|||-0.26|-0.53|<0.001
74030087|NCT02345161|147614216|SUPERIORITY_OR_OTHER||LS Mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|95.0|-0.5|-0.22|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 21-24|||-0.22|-0.50|<0.001
74030088|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.311||0.094|TWO_SIDED|95.0|-1.13|0.09|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4|||0.09|-1.13|0.094
73932275|NCT00799617|147394594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.79|-0.19||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect|||||-0.19|-0.79|<0.001
73932276|NCT00799617|147394595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72||||0.004|TWO_SIDED|95.0|-1.2|-0.23||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect|||||-0.23|-1.20|0.004
73932277|NCT00799617|147394596|SUPERIORITY||Mean Difference (Final Values)|47.0||||0.006|TWO_SIDED|95.0|13.0|80.0||Determined by linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||80|13|.006
73863769|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.43|0.68|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.68|0.43|
73863770|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.43|0.77|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.77|0.43|
73863771|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.67|1.08|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.08|0.67|
74030089|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-1.07|STANDARD_ERROR_OF_MEAN|0.371||0.004|TWO_SIDED|95.0|-1.8|-0.34|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8|||-0.34|-1.80|0.004
74030090|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.419||0.022|TWO_SIDED|95.0|-1.79|-0.14|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12|||-0.14|-1.79|0.022
74030091|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.445||0.024|TWO_SIDED|95.0|-1.88|-0.13|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16|||-0.13|-1.88|0.024
74030092|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.481||0.021|TWO_SIDED|95.0|-2.06|-0.17|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20|||-0.17|-2.06|0.021
74030093|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.481||0.022|TWO_SIDED|95.0|-2.05|-0.16|||Mixed Model Repeated Measures||EXACT-RS Score, Week 21-24|||-0.16|-2.05|0.022
74030094|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.492||0.008|TWO_SIDED|95.0|-2.29|-0.35|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 25-28|||-0.35|-2.29|0.008
74030095|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-1.43|STANDARD_ERROR_OF_MEAN|0.494||0.004|TWO_SIDED|95.0|-2.4|-0.46|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 29-32|||-0.46|-2.40|0.004
74030096|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.519||0.004|TWO_SIDED|95.0|-2.52|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 33-36|||-0.48|-2.52|0.004
74030097|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.507||0.016|TWO_SIDED|95.0|-2.22|-0.23|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 37-40|||-0.23|-2.22|0.016
74030098|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-1.49|STANDARD_ERROR_OF_MEAN|0.513||0.04|TWO_SIDED|95.0|-2.5|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 41-44|||-0.48|-2.50|0.04
74030099|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-1.53|STANDARD_ERROR_OF_MEAN|0.525||0.007|TWO_SIDED|95.0|-2.56|-0.5|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 45-49|||-0.50|-2.56|0.007
74030100|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.524||0.007|TWO_SIDED|95.0|-2.45|-0.39|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 49-52|||-0.39|-2.45|0.007
74030101|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.169||0.051|TWO_SIDED|95.0|-0.66|0.0|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 1-4|||0.00|-0.66|0.051
74030102|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.207||0.003|TWO_SIDED|95.0|-1.02|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 5-8|||-0.20|-1.02|0.003
74030103|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.234||0.01|TWO_SIDED|95.0|-1.07|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 9-12|||-0.15|-1.07|0.010
74030104|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.247||0.013|TWO_SIDED|95.0|-1.1|-0.13|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 13-16|||-0.13|-1.10|0.013
74030105|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.265||0.012|TWO_SIDED|95.0|-1.19|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 17-20|||-0.15|-1.19|0.012
74030106|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.268||0.018|TWO_SIDED|95.0|-1.16|-0.11|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 21-24|||-0.11|-1.16|0.018
74030107|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.275||0.006|TWO_SIDED|95.0|-1.3|-0.21|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 25-28|||-0.21|-1.30|0.006
74030108|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.276||0.002|TWO_SIDED|95.0|-1.4|-0.31|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 29-32|||-0.31|-1.40|0.002
74030109|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.288||0.001|TWO_SIDED|95.0|-1.51|-0.38|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 33-36|||-0.38|-1.51|0.001
74030110|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.287||0.008|TWO_SIDED|95.0|-1.32|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 37-40|||-0.20|-1.32|0.008
74030111|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.294||0.006|TWO_SIDED|95.0|-1.4|-0.24|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 41-44|||-0.24|-1.40|0.006
74030112|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.299||0.004|TWO_SIDED|95.0|-1.44|-0.27|||Breathlessness score, Week 41-44||Breathlessness EXACT-RS score, Week 45-48|||-0.27|-1.44|0.004
74030113|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.294||0.003|TWO_SIDED|95.0|-1.45|-0.3|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 49-52EXA|||-0.30|-1.45|0.003
73863772|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.71|1.12|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.12|0.71|
73863773|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.24|0.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.49|0.24|
73863774|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.26|0.51|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.51|0.26|
73863775|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.6|1.02|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.02|0.60|
73863776|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.54|0.87|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.87|0.54|
73932278|NCT00799617|147394597|SUPERIORITY||Mean Difference (Final Values)|-27.0||||0.31|TWO_SIDED|95.0|-80.0|26.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||26|-80|.31
73932279|NCT00799617|147394598|SUPERIORITY||Mean Difference (Final Values)|2.9|||<|0.001|TWO_SIDED|95.0|2.1|3.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||3.7|2.1|<.001
73932280|NCT00799617|147394599|SUPERIORITY||Mean Difference (Final Values)|4.2|||<|0.001|TWO_SIDED|95.0|3.2|5.3||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||5.3|3.2|<.001
73932281|NCT00799617|147394600|SUPERIORITY||Median Difference (Final Values)|1.5|||<|0.001|TWO_SIDED|95.0|0.9|2.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.0|0.9|<.001
73932282|NCT00799617|147394601|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.5|1.5||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.5|0.5|<.001
73932283|NCT00799617|147394602|SUPERIORITY||Mean Difference (Final Values)|1.3|||<|0.001|TWO_SIDED|95.0|0.8|1.7|||Regression, Linear|||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."||1.7|0.8|<.001
73932284|NCT00799617|147394603|SUPERIORITY||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.3|809.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||809|5.3|<.001
73932285|NCT00799617|147394604|SUPERIORITY||Mean Difference (Final Values)|8.5|||<|0.001|TWO_SIDED|95.0|6.0|10.9||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||10.9|6.0|<.001
73932286|NCT00799617|147394605|SUPERIORITY||Mean Difference (Final Values)|5.7|||<|0.001|TWO_SIDED|95.0|4.3|7.2||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||7.2|4.3|<.001
73932287|NCT00799617|147394606|SUPERIORITY||Mean Difference (Final Values)|1.8|||<|0.001|TWO_SIDED|95.0|1.1|2.6||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.6|1.1|<.001
73932288|NCT00799617|147394607|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.005|TWO_SIDED|95.0|0.3|1.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.7|0.3|.005
74030114|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.091||0.84|TWO_SIDED|95.0|-0.2|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 1-4|||0.16|-0.20|0.840
73932289|NCT00799617|147394608|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.5|1.4||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.4|0.5|<.001
73932290|NCT00799617|147394609|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.01|TWO_SIDED|95.0|0.25|2.09||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.09|0.25|.01
73932291|NCT00799617|147394610|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.052|TWO_SIDED|95.0|-0.01|1.36||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.36|-0.01|.052
73932292|NCT00799617|147394611|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.27|TWO_SIDED|95.0|-0.45|1.58||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.58|-0.45|0.27
73932293|NCT00799617|147394612|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.24|TWO_SIDED|95.0|-0.76|0.19||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||0.19|-0.76|.24
73932294|NCT00799617|147394613|SUPERIORITY||Mean Difference (Net)|-0.12||||0.89|TWO_SIDED|95.0|-1.89|1.65||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||1.65|-1.89|.89
74030115|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.106||0.167|TWO_SIDED|95.0|-0.36|-0.06|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 5-8|||-0.06|-0.36|0.167
74030116|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.117||0.359|TWO_SIDED|95.0|-0.34|0.12|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 9-12|||0.12|-0.34|0.359
74030117|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.124||0.36|TWO_SIDED|95.0|-0.36|0.13|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 13-16|||0.13|-0.36|0.360
74030118|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.134||0.49|TWO_SIDED|95.0|-0.36|0.17|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 17-20|||0.17|-0.36|0.490
74088704|NCT03465436|147730587|SUPERIORITY||LS Mean|-15.29|||||TWO_SIDED|90.0|-32.94|2.37|||Mixed Models Analysis|||4 hours postdose||2.37|-32.94|
73932295|NCT00799617|147394614|SUPERIORITY||Mean Difference (Net)|-5.51||||0.14|TWO_SIDED|95.0|-12.91|1.88||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||1.88|-12.91|.14
73932296|NCT00799617|147394615|SUPERIORITY||Mean Difference (Net)|0.83|||<|0.001|TWO_SIDED|95.0|0.48|1.39||The P-value for the significance of the treatment effect was determined by a linear mixed model for continuous outcomes with a random intercept for participant.|Mixed Models Analysis||Intent-to-treat analysis by a linear mixed effects model adjusted for balancing factors.|||1.39|0.48|<.001
73957788|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.189|STANDARD_ERROR_OF_MEAN|0.424||0.6551|TWO_SIDED|95.0|-1.021|0.643|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.643|-1.021|0.6551
73957789|NCT00383188|147451052|SUPERIORITY||LSM Difference|0.018|STANDARD_ERROR_OF_MEAN|0.356||0.9602|TWO_SIDED|95.0|-0.682|0.718|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.718|-0.682|0.9602
73957790|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.351||0.0198|TWO_SIDED|95.0|-1.51|-0.131|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.131|-1.510|0.0198
73957791|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.948|STANDARD_ERROR_OF_MEAN|0.409||0.0208|TWO_SIDED|95.0|-1.751|-0.145|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.145|-1.751|0.0208
73957792|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.433|STANDARD_ERROR_OF_MEAN|0.424||0.3077|TWO_SIDED|95.0|-1.265|0.4|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.400|-1.265|0.3077
73957793|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.211|STANDARD_ERROR_OF_MEAN|0.356||0.555|TWO_SIDED|95.0|-0.911|0.49|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.490|-0.911|0.5550
73863777|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.53|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.82|0.53|
73863778|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.69|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.69|
73863779|NCT00574548|147273704|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.15|2.13|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||2.13|1.15|
73863780|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.55|0.75|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.75|0.55|
73863781|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.52|2.01|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||2.01|1.52|
73863782|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.66|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.66|0.49|
73863783|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|1.03|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.03|0.67|
73863784|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.79|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.79|0.57|
73932297|NCT01848990|147394619|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.05||||0.4516|TWO_SIDED|95.0|-0.08|0.18|||ANOVA|Analysis of variance (ANOVA) with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 participants (Pt) being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide \>90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.||0.18|-0.08|0.4516
73957794|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.795|STANDARD_ERROR_OF_MEAN|0.351||0.0239|TWO_SIDED|95.0|-1.485|-0.106|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.106|-1.485|0.0239
73863785|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.52|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.52|0.35|
73863786|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.69|0.41|
73863787|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.75|
73863788|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.85|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.85|0.58|
73863789|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.74|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.74|0.58|
73863790|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.39|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.39|0.89|
73863791|NCT00574548|147273705|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.5|0.73|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.73|0.50|
73863792|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|2.03|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.55|2.03|
73863793|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.18|1.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.89|1.18|
73863794|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|2.07|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.55|2.07|
73863795|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.77|3.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.61|1.77|
73863796|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.94|3.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.88|1.94|
73863797|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|8.5|||||TWO_SIDED|95.0|5.68|12.6|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||12.60|5.68|
73863798|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|6.7|||||TWO_SIDED|95.0|4.45|10.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||10.22|4.45|
73863799|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.02|2.18|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.18|1.02|
74030119|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.138||0.388|TWO_SIDED|95.0|-0.39|0.15|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 21-24|||0.15|-0.39|0.388
73863800|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.8|||||TWO_SIDED|95.0|2.01|3.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.89|2.01|
73863801|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.92|3.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.13|1.92|
74030120|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.137||0.218|TWO_SIDED|95.0|-0.44|0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 25-28|||0.10|-0.44|0.218
74030121|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.136||0.138|TWO_SIDED|95.0|-0.47|0.07|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 29-32|||0.07|-0.47|0.138
74088705|NCT03465436|147730587|SUPERIORITY||LS Mean|6.13|||||TWO_SIDED|90.0|-10.86|23.11|||Mixed Models Analysis|||6 hours postdose||23.11|-10.86|
73863802|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.8|3.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.44|1.80|
73863803|NCT00574548|147273706|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.9|||||TWO_SIDED|95.0|1.92|4.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||4.28|1.92|
73863804|NCT02100969|147273751|SUPERIORITY||"proportion of successes"|0.864||||0.0179|TWO_SIDED|95.0|0.72|1.0||No adjustment is required as we are not doing multiple comparisons for the primary outcome analyses.|One sample Z test of proportions||One sample Z test of proportions is used. Method of handling missing data (as per protocol) is Last Observation Carried Forward (LOCF). Only 2 participants had missing values and in our case the LOCF results reflect a 'best-case' scenario.|"Sample size/power calculations are mentioned in the study protocol.~The study hypotheses are as follows:~H0: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase ≤ 0.65 HA: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase \> 0.65"||1.000|0.720|0.0179
73863805|NCT02100969|147273752|SUPERIORITY||Median Difference (Net)|0.0||||0.113|TWO_SIDED||||||Wilcoxon Signed Rank for paired data||The value of the signed rank test statistic is 44.50.|||||0.113
73863806|NCT02100969|147273753|SUPERIORITY||Median Difference (Net)|6.0||||0.612|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.612
73863807|NCT02100969|147273754|SUPERIORITY||Median Difference (Net)|2.0||||0.047|TWO_SIDED||||||Wilcoxon Signed Rank for paired data||The value of the signed-rank test statistic is 53.|||||0.047
73863808|NCT02100969|147273755|SUPERIORITY||Median Difference (Net)|5.6||||0.901|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.901
73863809|NCT02100969|147273756|SUPERIORITY||Median Difference (Net)|4.2||||0.51|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.510
73863810|NCT02100969|147273757|SUPERIORITY||Median Difference (Net)|8.3||||0.289|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.289
73863811|NCT02100969|147273758|SUPERIORITY||Median Difference (Net)|715.0||||0.0028|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.0028
74030122|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.44|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 33-36|||0.11|-0.44|0.239
73932298|NCT01848990|147394620|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.14||||0.0711|TWO_SIDED|95.0|-0.01|0.28|||ANOVA|ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 Pt being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide \>90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.||0.28|-0.01|0.0711
73932299|NCT01848990|147394621|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.69||||0.0105|TWO_SIDED|||||SMBG \<56 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0105
73863812|NCT03242252|147273776|SUPERIORITY||Difference in Least Squares (LS) Means|-0.1|STANDARD_ERROR_OF_MEAN|0.076||0.2095|TWO_SIDED|95.0|-0.245|0.054|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of Chronic Kidney Disease (CKD) stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.054|-0.245|0.2095
73863813|NCT03242252|147273776|SUPERIORITY||Difference in LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.077||0.0021|TWO_SIDED|95.0|-0.386|-0.085|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.085|-0.386|0.0021
73863814|NCT03242252|147273777|SUPERIORITY||Difference in LS Means|-0.587|STANDARD_ERROR_OF_MEAN|0.2397||0.0144|TWO_SIDED|95.0|-1.0564|-0.1169|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.||-0.1169|-1.0564|0.0144
73863815|NCT03242252|147273777|SUPERIORITY||Difference in LS Means|-0.478|STANDARD_ERROR_OF_MEAN|0.2368||0.0436|TWO_SIDED|95.0|-0.942|-0.0136|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.||-0.0136|-0.942|0.0436
73863816|NCT03242252|147273778|SUPERIORITY||Difference in LS Means|-2.28|STANDARD_ERROR_OF_MEAN|2.034||0.2627|TWO_SIDED|95.0|-6.265|1.709|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.||1.709|-6.265|0.2627
73932300|NCT01848990|147394621|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.79||||0.013|TWO_SIDED|||||SMBG \<=70 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0130
73932301|NCT01848990|147394621|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.78||||0.0511|TWO_SIDED|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII|||||0.0511
74030123|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.138||0.417|TWO_SIDED|95.0|-0.38|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 37-40|||0.16|-0.38|0.417
74088706|NCT03465436|147730587|SUPERIORITY||LS Mean|2.27|||||TWO_SIDED|90.0|-15.25|19.8|||Mixed Models Analysis|||8 hours postdose||19.80|-15.25|
73863817|NCT03242252|147273778|SUPERIORITY||Difference in LS Means|-2.53|STANDARD_ERROR_OF_MEAN|1.799||0.1602|TWO_SIDED|95.0|-6.052|1.0|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.||1|-6.052|0.1602
73863818|NCT03242252|147273779|SUPERIORITY||Difference in LS Means|-1.59|STANDARD_ERROR_OF_MEAN|1.301||0.2212|TWO_SIDED|95.0|-4.142|0.958|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.||0.958|-4.142|0.2212
73863819|NCT03242252|147273779|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|1.297||0.2089|TWO_SIDED|95.0|-4.171|0.912|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.||0.912|-4.171|0.2089
73863820|NCT03242252|147273780|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|0.326|<|0.0001|TWO_SIDED|95.0|-1.92|-0.644|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.||-0.644|-1.92|< 0.0001
73863821|NCT03242252|147273780|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|0.339||0.0155|TWO_SIDED|95.0|-1.487|-0.156|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.||-0.156|-1.487|0.0155
73863822|NCT03242252|147273781|SUPERIORITY||Percent Difference|-30.72||||0.0015|TWO_SIDED|95.0|-44.78|-13.07|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.||-13.07|-44.78|0.0015
73863823|NCT03242252|147273781|SUPERIORITY||Percent Difference|-36.18||||0.0003|TWO_SIDED|95.0|-49.91|-18.68|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.||-18.68|-49.91|0.0003
74030124|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.144||0.078|TWO_SIDED|95.0|-0.54|0.03|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 41-44|||0.03|-0.54|0.078
74030125|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.058|TWO_SIDED|95.0|-0.54|0.01|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 45-48|||0.01|-0.54|0.058
73863824|NCT03242252|147273782|SUPERIORITY||Percentage Difference|1.5||||0.4328|TWO_SIDED|95.0|-2.23|5.21|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||5.21|-2.23|0.4328
73863825|NCT03242252|147273782|SUPERIORITY||Percentage Difference|1.5||||0.4328|TWO_SIDED|95.0|-2.2|5.17|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||5.17|-2.2|0.4328
73863826|NCT03242252|147273783|SUPERIORITY||Percentage Difference|6.0||||0.0614|TWO_SIDED|95.0|-0.23|12.21|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||12.21|-0.23|0.0614
73932302|NCT01848990|147394621|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.34||||0.1176|TWO_SIDED|||||Severe HEs|negative binomial model||Hylenex/Standard CSII|||||0.1176
73932303|NCT01848990|147394622|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.81||||0.0456|TWO_SIDED|||||SMBG \<56 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0456
73932304|NCT01848990|147394622|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.92||||0.2322|TWO_SIDED|||||SMBG \<=70 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.2322
73932305|NCT01848990|147394622|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.87||||0.1365|TWO_SIDED|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII|||||0.1365
73932306|NCT01848990|147394622|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.07||||0.8909|TWO_SIDED|||||Severe HEs|negative binomial model||Hylenex/Standard CSII|||||0.8909
73932307|NCT01848990|147394623|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.98||||0.7292|TWO_SIDED|||||SMBG \>240 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.7292
73932308|NCT01848990|147394623|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.95||||0.5895|TWO_SIDED|||||SMBG \>300 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.5895
73932309|NCT01848990|147394624|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.04||||0.5414|TWO_SIDED|||||SMBG \>240 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.5414
73932310|NCT01848990|147394624|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.03||||0.711|TWO_SIDED|||||SMBG \>300 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.7110
73932311|NCT01848990|147394625|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-3.4||||0.5394|TWO_SIDED|95.0|-14.2|7.5||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.5|-14.2|0.5394
73863827|NCT03242252|147273783|SUPERIORITY||Percentage Difference|7.4||||0.023|TWO_SIDED|95.0|1.08|13.65|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||13.65|1.08|0.023
73863828|NCT01116427|147273790|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)|||||||0.87
73863829|NCT01116427|147273791|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Wilcoxon rank sum test in which the total number of new lesions were converted to ranks and then compared between groups|Wilcoxon (Mann-Whitney)|||||||0.36
73863830|NCT01116427|147273792|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED|||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)|||||||0.93
73863831|NCT01116427|147273793|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED|||||Wilcoxon rank sum test in which percent brain volume change values per participant were converted to ranks and the ranks were compared between groups|Wilcoxon (Mann-Whitney)|||||||0.68
73863832|NCT01116427|147273794|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED|||||Wilcoxon rank sum test in which mean numbers of new lesions per participant were converted to ranks and compared between groups|Wilcoxon (Mann-Whitney)|||||||0.21
73863833|NCT01116427|147273795|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Fisher Exact|||||||0.65
73863834|NCT01116427|147273797|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||Wilcoxon rank sum test in which the change from baseline scores per subject were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.13
73863835|NCT01116427|147273798|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED|||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)|||||||0.06
73863836|NCT01116427|147273799|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)|||||||0.07
73863837|NCT01116427|147273800|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|||||Wilcoxon rank sum test in which the percent brain volume change values per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.88
73863838|NCT01116427|147273801|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Fisher Exact|||||||0.29
73863839|NCT01116427|147273803|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||Wilcoxon rank sum test in which the change from baseline scores per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.67
73863840|NCT03743064|147273814|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|1.284|STANDARD_ERROR_OF_MEAN|0.289|<|0.0001|TWO_SIDED|95.0|0.718|1.851|||ANOVA|||"To declare anamorelin superior to placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change in body weight from baseline over 12 weeks (H0w) and the corresponding alternative hypothesis (H1w) were:~H0w: MWa = MWp H1w: MWa ≠ MWp~Where MWa is the mean change in body weight from baseline over 12 weeks for the anamorelin arm and MWp is the mean change in body weight from baseline over 12 weeks for the placebo arm."||1.851|0.718|<0.0001
73863841|NCT03743064|147273815|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.399||0.7241|TWO_SIDED|95.0|-0.641|0.923|||ANOVA|||"To declare anamorelin superior to the placebo, both co-primary endpoints had to be significant. The null hypothesis for mean change from baseline over 12 weeks in patient 5-IASS (H0A) and the corresponding alternative (H1A) were:~H0A: MAa = MAp; H1A: MAa ≠ MAp~Where MAa is the mean change from baseline over 12 weeks in 5-IASS for the anamorelin arm and MAp is the mean change from baseline over 12 weeks in 5-IASS for the placebo arm."||0.923|-0.641|0.7241
73971627|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|182.631||||0.0023|TWO_SIDED|95.0|65.754|299.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||299.509|65.754|0.0023
73863842|NCT03743064|147273816|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.081|STANDARD_ERROR_OF_MEAN|0.579||0.0003|TWO_SIDED|95.0|0.946|3.216|||ANOVA|||||3.216|0.946|0.0003
73863843|NCT03743064|147273817|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.404|STANDARD_ERROR_OF_MEAN|0.476|<|0.0001|TWO_SIDED|95.0|1.471|3.337|||ANOVA|||||3.337|1.471|<0.0001
74030126|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.141||0.231|TWO_SIDED|95.0|-0.45|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 49-52|||0.11|-0.45|0.231
73863844|NCT03743064|147273818|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.629|STANDARD_ERROR_OF_MEAN|0.431||0.1443|TWO_SIDED|95.0|-0.215|1.472|||ANOVA|||||1.472|-0.215|0.1443
73863845|NCT03743064|147273819|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.452||0.7376|TWO_SIDED|95.0|-0.734|1.036|||ANOVA|||||1.036|-0.734|0.7376
73932312|NCT01848990|147394625|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|4.3||||0.4151|TWO_SIDED|95.0|-6.1|14.8||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||14.8|-6.1|0.4151
74030127|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.097||0.068|TWO_SIDED|95.0|-0.37|0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 1-4|||0.01|-0.37|0.068
74030128|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.118||0.006|TWO_SIDED|95.0|-0.56|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 5-8|||-0.09|-0.56|0.006
74030129|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.131||0.042|TWO_SIDED|95.0|-0.53|-0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 9-12|||-0.01|-0.53|0.042
74030130|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.136||0.027|TWO_SIDED|95.0|-0.57|-0.03|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 13-16|||-0.03|-0.57|0.027
74030131|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.146||0.01|TWO_SIDED|95.0|-0.67|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 17-20|||-0.09|-0.67|0.010
74030132|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.144||0.01|TWO_SIDED|95.0|-0.66|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 21-24|||-0.09|-0.66|0.010
74030133|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|-0.7|-0.12|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 25-28|||-0.12|-0.70|
73863846|NCT02648217|147273826|SUPERIORITY_OR_OTHER||Treatment Contrast|0.02||||0.8426|TWO_SIDED|95.0|-0.2|0.24|||Mixed model for repeated measurements|||The endpoint was analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. The model included treatment, sex, region, previous OAD treatment, pre-Ramadan trial exposure and visit as factors and age and baseline value of the endpoint as covariates. Interactions between visit and all factors and covariates are included in the model.||0.24|-0.20|0.8426
73932313|NCT01848990|147394625|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.993|TWO_SIDED|95.0|-9.5|9.6||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||9.6|-9.5|0.9930
73932314|NCT01848990|147394625|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.941|TWO_SIDED|95.0|-6.4|6.9||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.9|-6.4|0.9410
73932315|NCT01848990|147394626|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-4.8||||0.3239|TWO_SIDED|95.0|-14.3|4.7||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||4.7|-14.3|0.3239
73932316|NCT01848990|147394626|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.754|TWO_SIDED|95.0|-7.4|10.2||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||10.2|-7.4|0.7540
73932317|NCT01848990|147394626|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.7904|TWO_SIDED|95.0|-9.5|7.2||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.2|-9.5|0.7904
73932318|NCT01848990|147394626|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.6||||0.4016|TWO_SIDED|95.0|-8.5|3.4||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||3.4|-8.5|0.4016
74030134|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.152||0.011|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 29-32|||-0.09|-0.68|0.011
74030135|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.157||0.011|TWO_SIDED|95.0|-0.71|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 33-36|||-0.09|-0.71|0.011
74030136|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.151||0.014|TWO_SIDED|95.0|-0.67|-0.07|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 37-40|||-0.07|-0.67|0.014
74030137|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.153||0.007|TWO_SIDED|95.0|-0.72|-0.12|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 41-44|||-0.12|-0.72|0.007
74030138|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.006|TWO_SIDED|95.0|-0.76|-0.13|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 45-48|||-0.13|-0.76|0.006
74030139|NCT02345161|147614217|SUPERIORITY_OR_OTHER||LS Mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.163||0.013|TWO_SIDED|95.0|-0.73|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 49-52|||-0.09|-0.73|0.013
74030140|NCT02345161|147614226|SUPERIORITY_OR_OTHER||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|0.81||0.023|TWO_SIDED|95.0|0.3|3.4|||Mixed Model Repeated Measures||For QTcF|||3.4|0.3|0.023
74030141|NCT02345161|147614226|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.78||0.471|TWO_SIDED|95.0|-2.1|1.0|||Mixed Model Repeated Measures||For PR interval|||1.0|-2.1|0.471
74030142|NCT02345161|147614227|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.83||0.564|TWO_SIDED|95.0|-4.7|2.5|||Mixed Model Repeated Measures||For QTcF|||2.5|-4.7|0.564
74030143|NCT02345161|147614227|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.57||0.908|TWO_SIDED|95.0|-2.9|3.3|||Mixed Model Repeated Measures||For PR interval|||3.3|-2.9|0.908
74030144|NCT02345161|147614230|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.849|TWO_SIDED|95.0|-1.0|1.2|||Mixed Model Repeated Measures||Week 24, SBP|||1.2|-1.0|0.849
74088707|NCT03465436|147730587|SUPERIORITY||LS Mean|-11.95|||||TWO_SIDED|90.0|-33.46|9.56|||Mixed Models Analysis|||12 hours postdose||9.56|-33.46|
73932319|NCT01848990|147394627|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.4||||0.526|TWO_SIDED|95.0|-5.6|2.9|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.9|-5.6|0.5260
73932320|NCT01848990|147394628|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.5||||0.8049|TWO_SIDED|95.0|-3.7|4.7|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||4.7|-3.7|0.8049
73932321|NCT01848990|147394629|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%||||||0.8955||||||HbA1c \<7.0%|Chi-squared|||||||0.8955
73932322|NCT01848990|147394629|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%||||||0.8926||||||HbA1c ≤6.5%|Chi-squared|||||||0.8926
74008221|NCT03627767|147566487|SUPERIORITY||Difference in percentage|26.0|||<|0.0001|TWO_SIDED|95.0|19.9|32.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||32.0|19.9|< 0.0001
73932323|NCT01848990|147394630|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.13||||0.7735|TWO_SIDED|95.0|-0.76|1.03|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.03|-0.76|0.7735
73932324|NCT01848990|147394631|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.4948|TWO_SIDED|95.0|-4.1|2.0||Daily bolus dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.0|-4.1|0.4948
73932325|NCT01848990|147394631|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.3||||0.1099|TWO_SIDED|95.0|-0.5|5.2||Daily basal dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||5.2|-0.5|0.1099
73932326|NCT01848990|147394631|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.583|TWO_SIDED|95.0|-3.7|6.6||Daily total dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.6|-3.7|0.5830
73932327|NCT01848990|147394632|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.8778|TWO_SIDED|95.0|-1.0|1.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.1|-1.0|0.8778
73932328|NCT01848990|147394633|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.1||||0.3233|TWO_SIDED|95.0|-6.3|2.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.1|-6.3|0.3233
73932329|NCT01848990|147394635|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.0||||0.7708|TWO_SIDED|95.0|-5.8|7.8||Average glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.8|-5.8|0.7708
73932330|NCT01848990|147394635|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.8||||0.6058|TWO_SIDED|95.0|-5.0|8.6||Median glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||8.6|-5.0|0.6058
73932331|NCT01848990|147394635|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.7||||0.6571|TWO_SIDED|95.0|-4.0|2.5||Average daily standard deviation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.5|-4.0|0.6571
73932332|NCT01848990|147394636|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.2||||0.6252|TWO_SIDED|95.0|-11.3|6.9||Time per day \<56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.9|-11.3|0.6252
73932333|NCT01848990|147394636|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-5.5||||0.5929|TWO_SIDED|95.0|-25.9|14.9||Time per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||14.9|-25.9|0.5929
73932334|NCT01848990|147394636|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|6.9||||0.5207|TWO_SIDED|95.0|-14.4|28.3||Time per day \>70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||28.3|-14.4|0.5207
73932335|NCT01848990|147394636|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-23.3||||0.4754|TWO_SIDED|95.0|-87.8|41.2||Time per day \<140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||41.2|-87.8|0.4754
73932336|NCT01848990|147394636|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|23.9||||0.4644|TWO_SIDED|95.0|-40.7|88.6||Time per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||88.6|-40.7|0.4644
73932337|NCT01848990|147394636|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|TWO_SIDED|95.0|-54.2|59.8||Time per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||59.8|-54.2|0.9232
73932338|NCT01848990|147394636|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|18.4||||0.5151|TWO_SIDED|95.0|-37.5|74.4||Time per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||74.4|-37.5|0.5151
74008222|NCT03627767|147566487|SUPERIORITY||Difference in percentage|13.4|||||TWO_SIDED|95.0|6.3|20.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.6|6.3|
73932339|NCT01848990|147394637|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-33.5||||0.4216|TWO_SIDED|95.0|-115.9|48.9||Area per day \<56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||48.9|-115.9|0.4216
73932340|NCT01848990|147394637|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-84.7||||0.5697|TWO_SIDED|95.0|-379.2|209.8||Area per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||209.8|-379.2|0.5697
74088708|NCT03465436|147730587|SUPERIORITY||LS Mean|-0.31|||||TWO_SIDED|90.0|-17.32|16.69|||Mixed Models Analysis|||24 hours postdose||16.69|-17.32|
73863847|NCT01302054|147273907|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-2.63|-2.02||Statistical testing: one-sided, at alpha = 0.025.|t-test, 1 sided|||||-2.02|-2.63|<0.0001
73863848|NCT01302054|147273908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0079|TWO_SIDED|95.0|-0.87|-0.13||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used. Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Multiple hypothesis testing was carried out in a hierarchical sequentially rejective manner. Statistical testing between fesoterodine and placebo (Analysis of covariance \[ANCOVA\]) was carried out only if the change from baseline at Week 12 in UUI episodes for fesoterodine group was found statistically significant (paired t-test).||-0.13|-0.87|0.0079
73863849|NCT01302054|147273909|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0931|TWO_SIDED|95.0|-0.86|0.07||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||0.07|-0.86|0.0931
73863850|NCT01302054|147273910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.34||0.0438|TWO_SIDED|95.0|-1.37|-0.02||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||-0.02|-1.37|0.0438
73863851|NCT01302054|147273911|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel|||||||<0.0001
73863852|NCT01302054|147273912|SUPERIORITY_OR_OTHER|||||||0.0095|TWO_SIDED|||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel|||||||0.0095
73863853|NCT01302054|147273913|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.34|STANDARD_ERROR_OF_MEAN|1.91||0.0001|TWO_SIDED|95.0|-11.1|-3.58||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||-3.58|-11.10|0.0001
73863854|NCT01302054|147273914|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|9.01|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|5.12|12.91||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Concern Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||12.91|5.12|<0.0001
73863855|NCT01302054|147273914|SUPERIORITY_OR_OTHER||LS Mean Difference|7.75|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|3.87|11.62||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Coping Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||11.62|3.87|<0.0001
73932341|NCT01848990|147394637|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|342.9||||0.9241|TWO_SIDED|95.0|-6772.3|7458.2||Area per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7458.2|-6772.3|0.9241
73932342|NCT01848990|147394637|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|TWO_SIDED|95.0|-54.2|59.8||Area per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||59.8|-54.2|0.9232
73932343|NCT01848990|147394637|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|Mean Difference (Final Values)|258.2||||0.9423|TWO_SIDED|95.0|-6792.2|7308.7||Area per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Least squares mean treatment difference (Hylenex minus Standard CSII)|||7308.7|-6792.2|0.9423
73932344|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5246|TWO_SIDED|95.0|-0.7|0.4||Leisure activities|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.4|-0.7|0.5246
73863856|NCT01302054|147273914|SUPERIORITY_OR_OTHER||LS Mean Difference|6.52|STANDARD_ERROR_OF_MEAN|2.0||0.0012|TWO_SIDED|95.0|2.6|10.45||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Sleep Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||10.45|2.60|0.0012
73863857|NCT01302054|147273914|SUPERIORITY_OR_OTHER||LS Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|1.64||0.0123|TWO_SIDED|95.0|0.9|7.36||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Social Interaction Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||7.36|0.90|0.0123
73863858|NCT01302054|147273914|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|1.77|<|0.0001|TWO_SIDED|95.0|3.63|10.57||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Total HRQL - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||10.57|3.63|<0.0001
73863859|NCT01302054|147273915|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0023
73932345|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.1||||0.638|TWO_SIDED|95.0|-0.8|0.5||Work life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.8|0.6380
73932346|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5719|TWO_SIDED|95.0|-0.7|0.4||Local or long distance travel|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.4|-0.7|0.5719
73932347|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.4052|TWO_SIDED|95.0|-0.8|0.3||Vacations|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.8|0.4052
73932348|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.724|TWO_SIDED|95.0|-0.4|0.6||Do physically|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.7240
73863860|NCT01302054|147273916|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0027
73932349|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6876|TWO_SIDED|95.0|-0.4|0.6||Family life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6876
73932350|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6478|TWO_SIDED|95.0|-0.4|0.6||Friendships and social life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6478
73932351|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9744|TWO_SIDED|95.0|-0.6|0.6||Close personal relationship|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.6|0.9744
73932352|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3177|TWO_SIDED|95.0|-0.3|0.8||Sex life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.8|-0.3|0.3177
74030145|NCT02345161|147614230|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.38||0.613|TWO_SIDED|95.0|-0.6|0.9|||Mixed Model Repeated Measures||Week 24, DBP|||0.9|-0.6|0.613
73932353|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.2087|TWO_SIDED|95.0|-0.2|0.7||Physical appearance|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.7|-0.2|0.2087
73932354|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.7907|TWO_SIDED|95.0|-0.4|0.5||Self-confidence|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.4|0.7907
73971628|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-175.901||||0.1612|TWO_SIDED|95.0|-390.865|39.063|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||39.063|-390.865|0.1612
74008223|NCT03627767|147566487|SUPERIORITY||Difference in percentage|11.7|||<|0.0001|TWO_SIDED|95.0|6.5|16.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||16.8|6.5|< 0.0001
74008224|NCT03627767|147566487|SUPERIORITY||Difference in percentage|25.7|||<|0.0001|TWO_SIDED|95.0|19.6|31.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.8|19.6|< 0.0001
74030146|NCT02345161|147614231|SUPERIORITY_OR_OTHER||: LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.19||0.183|TWO_SIDED|95.0|-3.9|0.8|||Mixed Model Repeated Measures||Week 52, SBP|||0.8|-3.9|0.183
74030147|NCT02345161|147614231|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.75||0.253|TWO_SIDED|95.0|-2.3|0.6|||Mixed Model Repeated Measures||Week 52, DBP|||0.6|-2.3|0.253
74030148|NCT02345161|147614233|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.45||0.526|TWO_SIDED|95.0|-0.6|1.2|||Mixed Model Repeated Measures|||||1.2|-0.6|0.526
73932355|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.3||||0.3444|TWO_SIDED|95.0|-0.8|0.3||Motivation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.8|0.3444
73932356|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.2175|TWO_SIDED|95.0|-0.1|0.6||The way people in general react|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.1|0.2175
73932357|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.4||||0.2062|TWO_SIDED|95.0|-1.0|0.2||Feelings about the future|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.2|-1.0|0.2062
73932358|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.8762|TWO_SIDED|95.0|-0.5|0.6||Financial situation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.5|0.8762
73932359|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.89|TWO_SIDED|95.0|-0.5|0.5||Living situation and conditions|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.5|0.8900
73932360|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.5||||0.1367|TWO_SIDED|95.0|-1.1|0.2||Depend on others|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.2|-1.1|0.1367
74030149|NCT02345161|147614234|SUPERIORITY_OR_OTHER||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.96||0.007|TWO_SIDED|95.0|0.7|4.5|||Mixed Model Repeated Measures|||||4.5|0.7|0.007
74088709|NCT03465436|147730588|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|90.0|-0.37|0.41|||Mixed Models Analysis|||30 minutes postdose||0.41|-0.37|
74088710|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.23|||||TWO_SIDED|90.0|-0.61|0.15|||Mixed Models Analysis|||1 hour postdose||0.15|-0.61|
74088711|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.12|||||TWO_SIDED|90.0|-0.47|0.23|||Mixed Models Analysis|||1.5 hours postdose||0.23|-0.47|
73863861|NCT01302054|147273917|SUPERIORITY_OR_OTHER|||||||0.0427|TWO_SIDED|||||Treatment difference at Week 4: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0427
73863862|NCT01302054|147273917|SUPERIORITY_OR_OTHER|||||||0.1461|TWO_SIDED|||||Treatment difference at Week 12: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.1461
73863863|NCT02411929|147273935|SUPERIORITY_OR_OTHER||Test (oral)/Reference (IV) of means|104.73|||||TWO_SIDED|90.0|101.64|107.91|||||Natural log transformed AUCinf(dn) and AUClast(dn) from Period 1 were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences were exponentiated.|Ratio - Test (oral) / Reference (IV) of means||107.91|101.64|
73863864|NCT02411929|147273945|SUPERIORITY_OR_OTHER||Ratio|110.71|||||||||||||The ratio (Test/Reference) of the geometric means of dose normalized natural log transformed Total 14\^C in Urine will be estimated. Total 14\^C\_Urine\_IV is the Reference formulation and Total 14C\_Urine\_Oral is the Test formulation (expressed as a %).|Ratio - Test (Oral) / Reference (IV) (%)||||
73863865|NCT02715726|147273952|SUPERIORITY||LS mean difference|-35.6|||<|0.0001|TWO_SIDED|95.0|-40.6|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-30.7|-40.6|<0.0001
73863866|NCT02715726|147273953|SUPERIORITY||LS mean difference|-37.3|||<|0.0001|TWO_SIDED|95.0|-42.1|-32.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|A hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-32.6|-42.1|<0.0001
73863867|NCT02715726|147273954|SUPERIORITY||LS mean difference|-34.9|||<|0.0001|TWO_SIDED|95.0|-39.5|-30.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.2|-39.5|<0.0001
73863868|NCT02715726|147273955|SUPERIORITY||LS mean difference|-35.4|||<|0.0001|TWO_SIDED|95.0|-40.0|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.7|-40.0|<0.0001
74008225|NCT03627767|147566487|SUPERIORITY||Difference in percentage|14.1|||||TWO_SIDED|95.0|7.0|21.2||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||21.2|7.0|
73863869|NCT02715726|147273956|SUPERIORITY|Threshold for significance at 0.05 level.|LS mean difference|-27.4|||<|0.0001|TWO_SIDED|95.0|-30.8|-23.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.9|-30.8|<0.0001
73863870|NCT02715726|147273957|SUPERIORITY||LS mean difference|-27.8|||<|0.0001|TWO_SIDED|95.0|-31.2|-24.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.4|-31.2|<0.0001
74008226|NCT03627767|147566487|SUPERIORITY||Difference in percentage|14.6|||<|0.0001|TWO_SIDED|95.0|9.2|20.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.0|9.2|< 0.0001
74030150|NCT02238028|147614257|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Paired t-test,2 sided|||Paired Student's t tests were used in the absence and presence of wearing respirators. HRV was log-transformed before regression analyses. Linear mixed-effect models were applied to investigate the effects of wearing respirators. Age, sex, body mass index, PM2.5 concentration, 48-h mean temperature and 48-h mean humidity were introduced into the model as fixed-effect terms. At last, we incorporated random-effect intercepts for subjects to account for correlations between repeated measurements.||||<0.05
74030151|NCT02238028|147614258|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test,2 sided|||||||<0.05
73863871|NCT02715726|147273958|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-31.8|-23.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.6|-31.8|<0.0001
73863872|NCT02715726|147273959|SUPERIORITY||LS mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-32.6|-24.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.7|-32.6|<0.0001
73863873|NCT02715726|147273960|SUPERIORITY||LS mean difference|-20.2|||<|0.0001|TWO_SIDED|95.0|-23.1|-17.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17.2|-23.1|<0.0001
73863874|NCT02715726|147273961|SUPERIORITY||LS mean difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-29.8|-23.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.2|-29.8|<0.0001
73863875|NCT02715726|147273962|SUPERIORITY||LS mean difference|-26.7|||<|0.0001|TWO_SIDED|95.0|-30.5|-22.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.8|-30.5|<0.0001
74030152|NCT00305006|147614271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.0|<|0.01|TWO_SIDED|95.0||||ANOVA|ANOVA|||ANOVA||||<0.01
74030153|NCT02606045|147614273|SUPERIORITY||Mean Difference (Final Values)|46.0||||0.039|TWO_SIDED|95.0|2.0|90.0|||Mixed Models Analysis|||||90|2|0.039
73863876|NCT02715726|147273963|SUPERIORITY||LS mean difference|-19.3|||<|0.0001|TWO_SIDED|95.0|-22.1|-16.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-16.5|-22.1|<0.0001
73863877|NCT02715726|147273964|SUPERIORITY||Odds Ratio (OR)|11.2|||<|0.0001|TWO_SIDED|95.0|7.1|17.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||17.7|7.1|<0.0001
73863878|NCT02715726|147273965|SUPERIORITY||Odds Ratio (OR)|13.6|||<|0.0001|TWO_SIDED|95.0|8.3|22.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||22.3|8.3|<0.0001
73863879|NCT02715726|147273966|SUPERIORITY||Adjusted Mean Difference|-34.273|||<|0.0001|TWO_SIDED|95.0|-39.262|-29.285||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.285|-39.262|<0.0001
73863880|NCT02715726|147273967|SUPERIORITY||LS mean difference|1.9||||0.228|TWO_SIDED|95.0|-1.2|4.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.9|-1.2|0.2280
73863881|NCT01177969|147273974|SUPERIORITY_OR_OTHER|||||||0.04||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA|||||||.04
73971629|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-227.95||||0.0396|TWO_SIDED|95.0|-448.725|-7.175|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-7.175|-448.725|0.0396
74008227|NCT03627767|147566487|SUPERIORITY||Difference in percentage|24.5|||<|0.0001|TWO_SIDED|95.0|18.4|30.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.5|18.4|< 0.0001
74008228|NCT03627767|147566487|SUPERIORITY||Difference in percentage|10.0|||||TWO_SIDED|95.0|2.7|17.2||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||17.2|2.7|
74088712|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.44|||||TWO_SIDED|90.0|-0.81|-0.07|||Mixed Models Analysis|||2 hours postdose||-0.07|-0.81|
74088713|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.55|||||TWO_SIDED|90.0|-0.95|-0.15|||Mixed Models Analysis|||2.5 hours postdose||-0.15|-0.95|
74088714|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.38|||||TWO_SIDED|90.0|-0.77|0.0|||Mixed Models Analysis|||3 hours postdose||0.00|-0.77|
74008229|NCT03627767|147566488|SUPERIORITY||Difference in percentage|1.8|||=|0.6082|TWO_SIDED|95.0|-5.0|8.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.5|-5.0|= 0.6082
73863882|NCT01177969|147273975|SUPERIORITY_OR_OTHER|||||||0.25||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA|||||||.25
73863883|NCT01852383|147274003|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA|||||||<0.001
73863884|NCT01852383|147274004|SUPERIORITY_OR_OTHER||||||<|0.1||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|Corrlation|||||||<0.1
73863885|NCT01852383|147274005|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA|||||||<0.001
73863886|NCT01852383|147274006|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0||||Pearson correlation coefficient. Not adjusted for multiple comparisons. Alpha=0.05 for statistical significance threshold.|Pearson correlation|||Correlation of maximum duloxetine dose with change in Hamilton Depression Rating Scale scores from 0 Weeks to 12 Weeks.||||<.001
73863887|NCT00343382|147274047|SUPERIORITY_OR_OTHER|||||||0.1675|||||||Kruskal-Wallis|||||||0.1675
74008230|NCT03627767|147566488|SUPERIORITY||Difference in percentage|0.2|||=|0.964|TWO_SIDED|95.0|-6.7|7.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||7.0|-6.7|= 0.9640
74008231|NCT03627767|147566488|SUPERIORITY||Difference in percentage|-2.4|||||TWO_SIDED|95.0|-9.1|4.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||4.4|-9.1|
73863888|NCT00343382|147274047|SUPERIORITY_OR_OTHER|||||||0.5974|||||||Kruskal-Wallis|||||||0.5974
73863889|NCT00343382|147274048|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||Comparison of Rigors among arms.||||0.002
73863890|NCT00343382|147274048|SUPERIORITY_OR_OTHER|||||||0.006|||||||Kruskal-Wallis|||Comparison of Urinary Frequency among arms||||0.006
73863891|NCT00343382|147274048|SUPERIORITY_OR_OTHER|||||||0.03|||||||Kruskal-Wallis|||Comparison of nausea among arms||||0.030
73863892|NCT00343382|147274048|SUPERIORITY_OR_OTHER|||||||0.062|||||||Kruskal-Wallis|||Comparison of sweating among arms||||0.062
73863893|NCT03945019|147274051|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.||||||<0.0001
73863894|NCT03945019|147274052|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.||||||<0.0001
73863895|NCT02914561|147274063|SUPERIORITY||Stratified Percentage Difference|12.7||||0.0017|TWO_SIDED|95.0|4.7|20.7|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||20.7|4.7|0.0017
73863896|NCT02914561|147274063|SUPERIORITY||Stratified Percentage Difference|5.2||||0.173|TWO_SIDED|95.0|-2.4|12.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.7|-2.4|0.1730
74030154|NCT02606045|147614274|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|||||0.7|-0.7|0.998
74030155|NCT02606045|147614275|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.168|TWO_SIDED|95.0|-1.0|5.8|||Mixed Models Analysis|||||5.8|-1.0|0.168
74030156|NCT02606045|147614276|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.055|TWO_SIDED|95.0|-4.9|0.1|||Mixed Models Analysis|||||0.1|-4.9|0.055
74030157|NCT02606045|147614277|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.681|TWO_SIDED|95.0|-4.8|3.2|||Mixed Models Analysis|||||3.2|-4.8|0.681
74030158|NCT02606045|147614277|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.633|TWO_SIDED|95.0|-12.4|7.6|||Mixed Models Analysis|||Role limitations of physical health||7.6|-12.4|0.633
74030159|NCT02606045|147614277|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.362|TWO_SIDED|95.0|-5.7|15.3|||Mixed Models Analysis|||Role limitations of emotional health||15.3|-5.7|0.362
74030160|NCT02606045|147614277|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.375|TWO_SIDED|95.0|-7.4|2.8|||Mixed Models Analysis|||Energy/fatigue||2.8|-7.4|0.375
74030161|NCT02606045|147614277|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.068|TWO_SIDED|95.0|-0.3|7.4|||Mixed Models Analysis|||Emotional well-being||7.4|-0.3|0.068
74030162|NCT02606045|147614277|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.189|TWO_SIDED|95.0|-2.3|11.3|||Mixed Models Analysis|||Social functioning||11.3|-2.3|0.189
74030163|NCT02606045|147614277|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.489|TWO_SIDED|95.0|-9.2|4.5|||Mixed Models Analysis|||Pain||4.5|-9.2|0.489
74030164|NCT02606045|147614277|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.786|TWO_SIDED|95.0|-3.2|4.3|||Mixed Models Analysis|||General Health||4.3|-3.2|0.786
74030165|NCT02606045|147614278|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.098|TWO_SIDED|95.0|-2.3|0.2|||Mixed Models Analysis|||Physically Unhealthy Days||0.2|-2.3|0.098
74030166|NCT02606045|147614278|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.557|TWO_SIDED|95.0|-1.6|3.0|||Mixed Models Analysis|||Mentally Unhealthy Days||3.0|-1.6|0.557
73863897|NCT02914561|147274063|SUPERIORITY||Stratified Percentage Difference|12.0||||0.0023|TWO_SIDED|95.0|4.1|19.9|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||19.9|4.1|0.0023
73863898|NCT02914561|147274063|SUPERIORITY||Stratified Percentage Difference|1.8||||0.6038|TWO_SIDED|95.0|-5.2|8.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.7|-5.2|0.6038
73863899|NCT02914561|147274064|SUPERIORITY||Stratified Percentage Difference|5.5||||0.1365|TWO_SIDED|95.0|-2.0|12.9|||Cochran-Mantel-Haenszel|CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (0, \>=1) at Day 1.||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.9|-2.0|0.1365
74030167|NCT02606045|147614279|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.266|TWO_SIDED|95.0|0.8|2.7|||Mixed Models Analysis|||Cycle Severity Rating||2.7|0.8|0.266
74030168|NCT00907881|147614280|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Regression, Linear|Pearson correlation coefficient||||||0.0002
74030169|NCT01996319|147614287|SUPERIORITY_OR_OTHER||null hypoth|0.2021|||<|0.0001|TWO_SIDED|95.0|0.1583|0.246|||ANCOVA|||||0.2460|0.1583|<0.0001
74030170|NCT01996319|147614288|SUPERIORITY_OR_OTHER||Null hypoth|36.7126||||0.0399|TWO_SIDED|95.0|1.7241|71.7011|||ANCOVA|||||71.7011|1.7241|0.0399
74030171|NCT01671085|147614299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-50.49|||<|0.001|TWO_SIDED|90.0|-71.27|-29.7||P-value is for Day 43.|Mixed Effects Model Analysis|||||-29.70|-71.27|<0.001
74030172|NCT01671085|147614299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.11|||<|0.001|TWO_SIDED|90.0|-65.91|-24.31||P-value is for Day 57.|Mixed Effects Models Analysis|||||-24.31|-65.91|<0.001
74030173|NCT00637273|147614300|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|0.37|0.89||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide \>90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.||0.89|0.37|<.0001
73863900|NCT02914561|147274064|SUPERIORITY||Stratified Percentage Difference|2.4||||0.5103|TWO_SIDED|95.0|-4.8|9.5|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||9.5|-4.8|0.5103
73863901|NCT02914561|147274064|SUPERIORITY||Stratified Percentage Difference|0.1||||0.9797|TWO_SIDED|95.0|-6.5|6.6|||Cochran-Mantel-Haenszel|CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (\<=1, \>1) at Day 1.||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||6.6|-6.5|0.9797
73863902|NCT02914561|147274064|SUPERIORITY||Stratified Percentage Difference|2.4||||0.4264|TWO_SIDED|95.0|-3.9|8.8|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.8|-3.9|0.4264
73971630|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-352.366||||0.0002|TWO_SIDED|95.0|-573.315|-131.418|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-131.418|-573.315|0.0002
74008232|NCT03627767|147566488|SUPERIORITY||Difference in percentage|38.9|||<|0.0001|TWO_SIDED|95.0|31.2|46.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.5|31.2|< 0.0001
74008233|NCT03627767|147566488|SUPERIORITY||Difference in percentage|59.7|||<|0.0001|TWO_SIDED|95.0|52.7|66.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||66.7|52.7|< 0.0001
74030174|NCT00637273|147614300|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.131||0.0165|TWO_SIDED|95.0|0.06|0.57||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide \>90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.||0.57|0.06|0.0165
74030175|NCT00637273|147614301|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of \<7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||<.0001
74030176|NCT00637273|147614301|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of \<7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0015
74030177|NCT00637273|147614302|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||<.0001
74030178|NCT00637273|147614302|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0120
74030179|NCT00637273|147614303|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.1700
74030180|NCT00637273|147614303|SUPERIORITY_OR_OTHER|||||||0.0091|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0091
74088715|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.41|||||TWO_SIDED|90.0|-0.72|-0.1|||Mixed Models Analysis|||3.5 hours postdose||-0.10|-0.72|
73863903|NCT02914561|147274065|SUPERIORITY||Stratified Percentage Difference|13.7||||0.0839|TWO_SIDED|95.0|-1.0|28.4|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||28.4|-1.0|0.0839
73863904|NCT02914561|147274065|SUPERIORITY||Stratified Percentage Difference|1.5||||0.8288|TWO_SIDED|95.0|-12.1|15.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||15.0|-12.1|0.8288
73863905|NCT02914561|147274066|SUPERIORITY||Stratified Percentage Difference|20.6||||0.0038|TWO_SIDED|95.0|8.2|33.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||33.1|8.2|0.0038
73863906|NCT02914561|147274066|SUPERIORITY||Stratified Percentage Difference|5.8||||0.3466|TWO_SIDED|95.0|-6.6|18.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||18.3|-6.6|0.3466
73863907|NCT02914561|147274067|SUPERIORITY||Stratified Percentage Difference|6.9||||0.0963|TWO_SIDED|95.0|-1.4|15.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||15.2|-1.4|0.0963
73863908|NCT02914561|147274067|SUPERIORITY||Stratified Percentage Difference|4.2||||0.305|TWO_SIDED|95.0|-3.9|12.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.2|-3.9|0.3050
73863909|NCT02914561|147274067|SUPERIORITY||Stratified Percentage Difference|11.9||||0.0039|TWO_SIDED|95.0|3.7|20.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||20.2|3.7|0.0039
73863910|NCT02914561|147274067|SUPERIORITY||Stratified Percentage Difference|1.1||||0.7556|TWO_SIDED|95.0|-6.2|8.5|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.5|-6.2|0.7556
73863911|NCT02914561|147274068|SUPERIORITY||Stratified Percentage Difference|12.0||||0.0074|TWO_SIDED|95.0|3.2|20.8|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).||20.8|3.2|0.0074
73863912|NCT02914561|147274068|SUPERIORITY||Stratified Percentage Difference|5.5||||0.2159|TWO_SIDED|95.0|-3.2|14.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).||14.1|-3.2|0.2159
73863913|NCT02914561|147274068|SUPERIORITY||Stratified Percentage Difference|11.6||||0.011|TWO_SIDED|95.0|2.6|20.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||20.6|2.6|0.0110
73863914|NCT02914561|147274068|SUPERIORITY||Stratified Percentage Difference|8.2||||0.0593|TWO_SIDED|95.0|-0.4|16.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||16.7|-0.4|0.0593
73863915|NCT02914561|147274069|SUPERIORITY||Stratified Percentage Difference|16.8||||0.0382|TWO_SIDED|95.0|2.0|31.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||31.6|2.0|0.0382
73863916|NCT02914561|147274069|SUPERIORITY||Stratified Percentage Difference|5.8||||0.4263|TWO_SIDED|95.0|-8.5|20.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||20.0|-8.5|0.4263
73863917|NCT02914561|147274070|SUPERIORITY||Stratified Percentage Difference|10.9||||0.1827|TWO_SIDED|95.0|-4.7|26.4|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||26.4|-4.7|0.1827
73863918|NCT02914561|147274070|SUPERIORITY||Stratified Percentage Difference|4.0||||0.5944|TWO_SIDED|95.0|-11.1|19.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||19.2|-11.1|0.5944
74008234|NCT03627767|147566488|SUPERIORITY||Difference in percentage|20.9|||||TWO_SIDED|95.0|12.7|29.0||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.0|12.7|
74088716|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.35|||||TWO_SIDED|90.0|-0.66|-0.04|||Mixed Models Analysis|||4 hours postdose||-0.04|-0.66|
73863919|NCT02914561|147274071|SUPERIORITY||Stratified Percentage Difference|15.2||||0.0512|TWO_SIDED|95.0|1.0|29.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||29.3|1.0|0.0512
73863920|NCT02914561|147274071|SUPERIORITY||Stratified Percentage Difference|-0.2||||0.9801|TWO_SIDED|95.0|-13.3|13.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||13.0|-13.3|0.9801
73863921|NCT02914561|147274072|SUPERIORITY||Stratified Percentage Difference|14.0||||0.19|TWO_SIDED|95.0|-5.1|33.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||33.1|-5.1|0.1900
74008235|NCT03627767|147566488|SUPERIORITY||Difference in percentage|33.9|||<|0.0001|TWO_SIDED|95.0|26.6|41.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||41.2|26.6|< 0.0001
74008236|NCT03627767|147566488|SUPERIORITY||Difference in percentage|55.3|||<|0.0001|TWO_SIDED|95.0|48.2|62.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||62.3|48.2|< 0.0001
74008237|NCT03627767|147566488|SUPERIORITY||Difference in percentage|21.7|||||TWO_SIDED|95.0|13.2|30.2||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.2|13.2|
74030181|NCT00637273|147614304|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|0.416||0.0002|TWO_SIDED|95.0|0.72|2.35||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||2.35|0.72|0.0002
74088717|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.54|||||TWO_SIDED|90.0|-0.98|-0.09|||Mixed Models Analysis|||6 hours postdose||-0.09|-0.98|
73932361|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3144|TWO_SIDED|95.0|-0.3|0.9||Freedom to eat|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.9|-0.3|0.3144
73932362|NCT01848990|147394638|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6869|TWO_SIDED|95.0|-0.4|0.6||Freedom to drink|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6869
73932363|NCT01848990|147394639|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9901|TWO_SIDED|95.0|-0.3|0.3|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.3|0.9901
73932364|NCT01848990|147394640|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.9081|TWO_SIDED|95.0|-1.1|1.3||DTSQs|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.3|-1.1|0.9081
73932365|NCT01848990|147394640|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.984|TWO_SIDED|95.0|-1.5|1.6||DTSQc|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.6|-1.5|0.9840
73932366|NCT00958880|147394646|SUPERIORITY_OR_OTHER||Slope|10.46||||0.015||95.0|||||Regression, Linear|||||||.015
73932367|NCT00958880|147394647|SUPERIORITY_OR_OTHER||Slope|0.03||||0.575||95.0|||||Regression, Linear|||||||.575
73932368|NCT04011475|147394707|OTHER|||||||0.0276|||||||Log Rank|||||||0.0276
73932369|NCT04011475|147394707|OTHER||Hazard Ratio (HR)|0.875||||0.6665|TWO_SIDED|95.0|0.47|1.604|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group A versus group B using group B as reference.|||1.604|0.47|0.6665
73932370|NCT04011475|147394707|OTHER||Hazard Ratio (HR)|2.377||||0.031|TWO_SIDED|95.0|1.083|5.221|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group A versus group C using group C as reference.|||5.221|1.083|0.0310
73932371|NCT04011475|147394707|OTHER||Hazard Ratio (HR)|2.716||||0.0116|TWO_SIDED|95.0|1.25|5.901|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group B versus group C using group C as reference.|||5.901|1.250|0.0116
73932372|NCT04011475|147394708|OTHER||Rate ratio|0.67||||0.0756|TWO_SIDED|95.0|0.43|1.04|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.04|0.43|0.0756
73932373|NCT04011475|147394708|OTHER||Rate ratio|4.36|||<|0.0001|TWO_SIDED|95.0|2.27|8.4|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||8.40|2.27|< 0.0001
73932374|NCT04011475|147394708|OTHER||Rate ratio|0.34||||0.0022|TWO_SIDED|95.0|0.17|0.68|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.68|0.17|0.0022
73932375|NCT04011475|147394709|OTHER||Rate ratio|1.25||||0.7394|TWO_SIDED|95.0|0.34|4.65|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||4.65|0.34|0.7394
73932376|NCT04011475|147394710|OTHER||Rate ratio|0.65||||0.1116|TWO_SIDED|95.0|0.38|1.11|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.11|0.38|0.1116
73932377|NCT04011475|147394710|OTHER||Rate ratio|3.78||||0.0004|TWO_SIDED|95.0|1.81|7.88|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||7.88|1.81|0.0004
73932378|NCT04011475|147394710|OTHER||Rate ratio|0.41||||0.0239|TWO_SIDED|95.0|0.19|0.89|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.89|0.19|0.0239
73932379|NCT04011475|147394711|OTHER||Rate ratio|0.71||||0.4164|TWO_SIDED|95.0|0.32|1.61|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.61|0.32|0.4164
73932380|NCT04011475|147394711|OTHER||Rate ratio|7.0||||0.01|TWO_SIDED|95.0|1.59|30.8|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||30.8|1.59|0.0100
73932381|NCT04011475|147394711|OTHER||Rate ratio|0.2||||0.0377|TWO_SIDED|95.0|0.04|0.91|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.91|0.04|0.0377
73932382|NCT04011475|147394712|OTHER|||||||0.2035|||||||Log Rank|||||||0.2035
73932383|NCT04011475|147394713|OTHER|||||||0.1858|||||||Chi-squared|Chi-square test was applied for assessing the inter-group difference.||||||0.1858
73932384|NCT04011475|147394714|OTHER|||||||0.0144|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.0144
73932385|NCT04011475|147394714|OTHER|||||||0.9219|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.9219
73932386|NCT04011475|147394714|OTHER|||||||0.959|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.9590
73932387|NCT04011475|147394715|OTHER|||||||0.2909|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.2909
74088718|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.14|||||TWO_SIDED|90.0|-0.58|0.31|||Mixed Models Analysis|||8 hours postdose||0.31|-0.58|
73863922|NCT02914561|147274072|SUPERIORITY||Stratified Percentage Difference|-5.5||||0.4248|TWO_SIDED|95.0|-22.6|11.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||11.6|-22.6|0.4248
73863923|NCT02914561|147274073|SUPERIORITY||Stratified Percentage Difference|19.9||||0.0122|TWO_SIDED|95.0|5.7|34.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||34.0|5.7|0.0122
73863924|NCT02914561|147274073|SUPERIORITY||Stratified Percentage Difference|2.0||||0.7708|TWO_SIDED|95.0|-12.0|16.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||16.1|-12.0|0.7708
73863925|NCT02914561|147274074|SUPERIORITY||Stratified Percentage Difference|12.0||||0.2631|TWO_SIDED|95.0|-8.3|32.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||32.3|-8.3|0.2631
73863926|NCT02914561|147274074|SUPERIORITY||Stratified Percentage Difference|-3.4||||0.6444|TWO_SIDED|95.0|-20.9|14.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||14.0|-20.9|0.6444
73863927|NCT03869333|147274122|OTHER|||||||0.504|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.504
73932388|NCT04011475|147394715|OTHER|||||||0.1618|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.1618
73932389|NCT04011475|147394715|OTHER|||||||0.4695|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.4695
73932390|NCT04011475|147394716|OTHER||||||>|0.9999|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||> 0.9999
73971631|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-116.449||||0.5616|TWO_SIDED|95.0|-327.445|94.547|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||94.547|-327.445|0.5616
74030182|NCT00637273|147614304|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|0.415|<|0.0001|TWO_SIDED|95.0|4.28|5.91||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||5.91|4.28|<.0001
74030183|NCT00637273|147614305|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|15.5|STANDARD_ERROR_OF_MEAN|4.95||0.0038|TWO_SIDED|95.0|5.7|25.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||25.2|5.7|0.0038
73863928|NCT03869333|147274122|OTHER|||||||0.01|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22||||0.010
73863929|NCT03869333|147274122|OTHER|||||||0.038|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43||||0.038
73863930|NCT03869333|147274122|OTHER|||||||0.016|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.016
73863931|NCT03869333|147274122|OTHER|||||||0.058|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57||||0.058
73863932|NCT03869333|147274122|OTHER|||||||0.038|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71||||0.038
73863933|NCT03869333|147274123|OTHER|||||||0.129|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.129
73863934|NCT03869333|147274123|OTHER|||||||0.017|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22||||0.017
73932391|NCT04011475|147394716|OTHER|||||||0.2516|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.2516
73932392|NCT04011475|147394716|OTHER|||||||0.0036|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.0036
73932393|NCT04011475|147394717|OTHER|||||||0.6189|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.6189
73932394|NCT04011475|147394717|OTHER|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.7656
73932395|NCT04011475|147394717|OTHER|||||||0.3594|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.3594
73932396|NCT04011475|147394718|OTHER|||||||0.0483|||||||Chi-squared|Chi-square test was applied for assessing the inter-group difference.||||||0.0483
73932397|NCT00630877|147394770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73932398|NCT00630877|147394772|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
73863935|NCT03869333|147274123|OTHER|||||||0.008|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43||||0.008
73863936|NCT03869333|147274123|OTHER|||||||0.011|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.011
73863937|NCT03869333|147274123|OTHER|||||||0.029|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57||||0.029
73863938|NCT03869333|147274123|OTHER|||||||0.042|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71||||0.042
73932399|NCT00630877|147394773|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
73863939|NCT03869333|147274124|OTHER|||||||0.226|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.226
73863940|NCT03869333|147274124|OTHER|||||||0.601|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8||||0.601
73932400|NCT00630877|147394774|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
73932401|NCT00630877|147394775|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
73932402|NCT00630877|147394776|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Independent groups t-test|||||||0.002
73932403|NCT00630877|147394777|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Independent groups t-test|||||||<0.001
73932404|NCT02033889|147394787|SUPERIORITY||Difference in Least Squares Means|-0.88|||<|0.001|TWO_SIDED|95.0|-1.05|-0.71|||Constrained Longitudinal Data Analysis||||Based on Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-0.71|-1.05|<0.001
74030184|NCT00637273|147614305|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|4.98||0.3729|TWO_SIDED|95.0|-5.3|14.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||14.2|-5.3|0.3729
73932405|NCT02033889|147394787|SUPERIORITY||Difference in Least Squares Means|-0.7|||<|0.001|TWO_SIDED|95.0|-0.87|-0.53|||Constrained Longitudinal Data Analysis||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-0.53|-0.87|<0.001
74030185|NCT00637273|147614306|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|1.26||0.0055|TWO_SIDED|95.0|1.3|6.3||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||6.3|1.3|0.0055
74030186|NCT00637273|147614306|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.25||0.1117|TWO_SIDED|95.0|-0.5|4.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||4.5|-0.5|0.1117
74039399|NCT04847141|147632409|SUPERIORITY||Difference in Percentage|7.9||||0.1702|TWO_SIDED|95.0|-3.6|19.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 7||19.2|-3.6|0.1702
73932406|NCT02033889|147394789|OTHER||Difference in % vs Placebo/Glimepiride|1.5|||||TWO_SIDED|95.0|-2.1|5.4|||||||Miettinen \& Nurminen method was used to construct the 95% CI|5.4|-2.1|
73932407|NCT02033889|147394789|OTHER||Difference in % vs Placebo/Glimepiride|1.0|||||TWO_SIDED|95.0|-2.5|4.7|||||||Miettinen \& Nurminen method was used to construct the 95% CI|4.7|-2.5|
73932408|NCT02033889|147394790|SUPERIORITY||Difference in Least Squares Means|-38.25|||<|0.001|TWO_SIDED|95.0|-44.5|-31.99|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-31.99|-44.50|<0.001
73932409|NCT02033889|147394790|SUPERIORITY||Difference in the Least Squares Means|-26.69|||<|0.001|TWO_SIDED|95.0|-32.9|-20.48|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-20.48|-32.90|<0.001
73932410|NCT02033889|147394791|SUPERIORITY||Difference in Least Squares Means|-1.6|||<|0.001|TWO_SIDED|95.0|-2.16|-1.03|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-1.03|-2.16|<0.001
73863941|NCT03869333|147274124|OTHER|||||||0.628|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29||||0.628
73863942|NCT03869333|147274124|OTHER|||||||0.878|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.878
73863943|NCT03869333|147274125|OTHER|||||||0.762|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.762
73863944|NCT03869333|147274125|OTHER|||||||0.335|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8||||0.335
73863945|NCT03869333|147274125|OTHER|||||||0.229|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29||||0.229
73863946|NCT03869333|147274125|OTHER|||||||0.102|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.102
73863947|NCT03869333|147274126|OTHER|||||||0.828|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.||||0.828
73863948|NCT03869333|147274126|OTHER|||||||0.629|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43||||0.629
73863949|NCT03869333|147274126|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||>0.999
73863950|NCT03869333|147274126|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57||||>0.999
73863951|NCT03869333|147274126|OTHER|||||||0.825|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71||||0.825
73863952|NCT03869333|147274127|OTHER|||||||0.005|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.||||0.005
73971632|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-162.635||||0.2176|TWO_SIDED|95.0|-375.57|50.299|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||50.299|-375.570|0.2176
73971633|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-236.196||||0.0242|TWO_SIDED|95.0|-451.334|-21.059|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-21.059|-451.334|0.0242
74030187|NCT00637273|147614307|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.75||0.1685|TWO_SIDED|95.0|-0.4|2.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||2.5|-0.4|0.1685
74030188|NCT00637273|147614307|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.75||0.1685|TWO_SIDED|95.0|-2.6|0.4||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||0.4|-2.6|0.1685
73863953|NCT03869333|147274127|OTHER|||||||0.082|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43||||0.082
73863954|NCT03869333|147274127|OTHER|||||||0.293|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.293
73863955|NCT03869333|147274127|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57||||>0.999
73863956|NCT03869333|147274127|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71||||>0.999
73863957|NCT03869333|147274128|OTHER|||||||0.828|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8||||0.828
73863958|NCT03869333|147274128|OTHER|||||||0.913|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29||||0.913
73863959|NCT03869333|147274128|OTHER|||||||0.924|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.924
73863960|NCT03869333|147274129|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8||||>0.999
73863961|NCT03869333|147274129|OTHER|||||||0.412|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29||||0.412
73863962|NCT03869333|147274129|OTHER|||||||0.847|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.847
73863963|NCT03869333|147274130|OTHER|||||||0.009|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22||||0.009
73863964|NCT03869333|147274130|OTHER|||||||0.037|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43||||0.037
73863965|NCT03869333|147274130|OTHER|||||||0.009|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.009
73863966|NCT03869333|147274130|OTHER|||||||0.036|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57||||0.036
73863967|NCT03869333|147274130|OTHER|||||||0.042|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71||||0.042
73863968|NCT03869333|147274131|OTHER|||||||0.028|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22||||0.028
73863969|NCT03869333|147274131|OTHER|||||||0.088|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43||||0.088
73863970|NCT03869333|147274131|OTHER|||||||0.146|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.146
73863971|NCT03869333|147274131|OTHER|||||||0.126|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57||||0.126
73863972|NCT03869333|147274131|OTHER|||||||0.273|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71||||0.273
73932411|NCT02033889|147394791|SUPERIORITY||Difference in Least Squares Means|-1.67|||<|0.001|TWO_SIDED|95.0|-2.24|-1.11|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-1.11|-2.24|<0.001
73932412|NCT02033889|147394792|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|4.48|||<|0.001|TWO_SIDED|95.0|2.64|7.62|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|7.62|2.64|<0.001
73932413|NCT02033889|147394792|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|3.03|||<|0.001|TWO_SIDED|95.0|1.81|5.06|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|5.06|1.81|<0.001
73971634|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-294.281|||<|0.0001|TWO_SIDED|95.0|-434.513|-154.05|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-154.050|-434.513|<.0001
74008238|NCT03627767|147566488|SUPERIORITY||Difference in percentage|29.7|||<|0.0001|TWO_SIDED|95.0|22.7|36.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||36.7|22.7|< 0.0001
73863973|NCT03869333|147274133|OTHER|||||||0.348|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 8||||0.348
73863974|NCT03869333|147274133|OTHER|||||||0.179|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 29||||0.179
73863975|NCT03869333|147274133|OTHER|||||||0.089|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.089
73863976|NCT03002454|147274138|EQUIVALENCE|"Control: 99mTc MDP Injection:fission Investigation: 99mTc MDP Injection:neutron-bombardment~Anticipated sample size of 50 participants with sample size parameters of:~Alpha 0.05 Power 80% Kappa of significance 0.7 - 0.8 Prevalence of abnormal bone scans 30%~Actual study population of 4 participants with 4 out of 4 demonstrating gross abnormal biodistribution therefore the study was terminated and no statistical analysis was conducted."|||||||||||||||||No statistical analysis - insufficient study population|||
73863977|NCT02963701|147274152|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|99.16|STANDARD_DEVIATION|8.49|||TWO_SIDED|90.0|96.52|101.89|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||101.89|96.52|
73863978|NCT02963701|147274153|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|89.16|STANDARD_DEVIATION|19.28|||TWO_SIDED|90.0|83.88|94.76|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||94.76|83.88|
73863979|NCT02963701|147274154|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.75|STANDARD_DEVIATION|12.96|||TWO_SIDED|90.0|95.73|103.95|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios \[%\] of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation \[%\].|||103.95|95.73|
73863980|NCT02963701|147274155|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|102.16|STANDARD_DEVIATION|15.37|||TWO_SIDED|90.0|97.3|107.27|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios \[%\] of Test and Reference products. The parameter dispersion type \[SD\] was actually the intra-individual geometric coefficient of variation \[%\].|||107.27|97.30|
73932414|NCT02033889|147394793|SUPERIORITY||Difference in Least Squares Means|-4.5|||<|0.001|TWO_SIDED|95.0|-6.81|-2.19|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-2.19|-6.81|<0.001
73932415|NCT02033889|147394793|SUPERIORITY||Difference in Least Squares Means|-3.68||||0.002|TWO_SIDED|95.0|-5.96|-1.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-1.39|-5.96|0.002
73932416|NCT02033889|147394794|SUPERIORITY||Difference in Least Squares Means|-2.42||||0.001|TWO_SIDED|95.0|-3.86|-0.98|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.98|-3.86|0.001
73932417|NCT02033889|147394794|SUPERIORITY||Difference in Least Squares Means|-1.82||||0.013|TWO_SIDED|95.0|-3.24|-0.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.39|-3.24|0.013
73932418|NCT02033889|147394795|SUPERIORITY||Adjusted Odds Ratio|5.41|||<|0.001|TWO_SIDED|95.0|2.1|13.9|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|13.90|2.10|<0.001
73932419|NCT02033889|147394795|SUPERIORITY||Adjusted Odds Ratio|3.1||||0.023|TWO_SIDED|95.0|1.17|8.22|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|8.22|1.17|0.023
73932420|NCT02033889|147394796|SUPERIORITY||Difference in % vs Placebo|-16.2|||<|0.001|TWO_SIDED|95.0|-22.2|-11.2|||Miettinen & Nurminen method|Miettinen \& Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).||||-11.2|-22.2|<0.001
73932421|NCT02033889|147394796|SUPERIORITY||Difference in % vs Placebo|-14.8|||<|0.001|TWO_SIDED|95.0|-20.9|-9.4|||Miettinen & Nurminen method.|Miettinen \& Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).||||-9.4|-20.9|<0.001
73932422|NCT02033889|147394815|OTHER||Difference in the Least Squares Means|-0.1|||||TWO_SIDED|95.0|-0.71|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.50|-0.71|
73932423|NCT02033889|147394815|OTHER||Difference in the Least Squares Means|-0.23|||||TWO_SIDED|97.0|-0.83|0.37|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.37|-0.83|
73932424|NCT02033889|147394816|OTHER||Difference in the Least Squares Means|0.7|||||TWO_SIDED|95.0|0.0|1.39|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|1.39|0.00|
73932425|NCT02033889|147394816|OTHER||Difference in the Least Squares Means|0.3|||||TWO_SIDED|95.0|-0.38|0.99|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.99|-0.38|
73932426|NCT02033889|147394817|OTHER||Difference in the Least Squares Means|0.27|||||TWO_SIDED|95.0|-0.15|0.68|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.68|-0.15|
73932427|NCT02033889|147394817|OTHER||Difference in the Least Squares Means|0.08|||||TWO_SIDED|95.0|-0.33|0.48|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.48|-0.33|
73863981|NCT02963701|147274156|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|98.97|STANDARD_DEVIATION|8.13|||TWO_SIDED|90.0|96.44|101.57|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%)of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||101.57|96.44|
74030189|NCT00637273|147614308|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|3.31||0.2686|TWO_SIDED|95.0|-2.8|10.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||10.2|-2.8|0.2686
73971635|NCT04800211|147483700|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-116.17||||0.1524|TWO_SIDED|95.0|-275.521|43.18|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||43.180|-275.521|0.1524
73971636|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-32.792|||<|0.0001|TWO_SIDED|95.0|-39.375|-26.208|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-26.208|-39.375|<.0001
73971637|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-25.921|||<|0.0001|TWO_SIDED|95.0|-33.398|-18.443|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-18.443|-33.398|<.0001
73971638|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-25.484|||<|0.0001|TWO_SIDED|95.0|-31.99|-18.979|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-18.979|-31.990|<.0001
73971639|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.899|||<|0.0001|TWO_SIDED|95.0|-34.135|-19.663|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-19.663|-34.135|<.0001
73971640|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.41|||<|0.0001|TWO_SIDED|95.0|-31.716|-21.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-21.103|-31.716|<.0001
74088719|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.29|||||TWO_SIDED|90.0|-0.7|0.12|||Mixed Models Analysis|||12 hours postdose||0.12|-0.70|
73863982|NCT02963701|147274157|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.67|STANDARD_DEVIATION|13.5|||TWO_SIDED|90.0|95.48|104.04|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||104.04|95.48|
73863983|NCT02963701|147274158|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|95.96|STANDARD_DEVIATION|14.27|||TWO_SIDED|90.0|91.7|100.4|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||100.40|91.70|
73863984|NCT02963701|147274159|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|96.12|STANDARD_DEVIATION|14.06|||TWO_SIDED|90.0|91.92|100.51|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||100.51|91.92|
73863985|NCT02963701|147274160|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|90.83|STANDARD_DEVIATION|21.49|||TWO_SIDED|90.0|84.87|97.21|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||97.21|84.87|
73863986|NCT02963701|147274161|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.86|STANDARD_DEVIATION|7.89|||TWO_SIDED|90.0|99.33|104.46|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||104.46|99.33|
73863987|NCT02963701|147274162|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.65|STANDARD_DEVIATION|7.01|||TWO_SIDED|90.0|99.4|103.95|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||103.95|99.40|
73863988|NCT02963701|147274163|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|86.53|STANDARD_DEVIATION|16.85|||TWO_SIDED|90.0|82.03|91.28|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||91.28|82.03|
73863989|NCT02963701|147274164|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|Ratio (%)|106.17|STANDARD_DEVIATION|14.77|||TWO_SIDED|90.0|101.3|111.26|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||111.26|101.30|
73863990|NCT03480009|147274170|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||.20
73863991|NCT03480009|147274170|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||.20
73863992|NCT03480009|147274171|OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Ibuprofen||||.81
73863993|NCT03480009|147274171|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||acetaminophen||||.24
73863994|NCT03480009|147274171|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||oxycodone||||.54
73863995|NCT03480009|147274171|OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Ibuprofen||||.61
73863996|NCT03480009|147274171|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Acetaminophen||||.24
73863997|NCT03480009|147274172|OTHER|||||||0.99|||||||Wald Chi Square|Wald Chi Square from mixed effects linear regression||||||.99
73932428|NCT02033889|147394818|OTHER||Difference in the Least Squares Means|-0.19|||||TWO_SIDED|95.0|-0.76|0.39|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.39|-0.76|
73863998|NCT03480009|147274172|OTHER|||||||0.56|||||||Wald Chi Square|P-value from Wald chi-square from mixed effects linear regression||||||.56
73863999|NCT03480009|147274173|OTHER|||||||0.07|||||||Fisher Exact|||||||.07
73864000|NCT03480009|147274173|OTHER|||||||0.5|||||||Fisher Exact|||||||.50
73864001|NCT00448747|147274242|OTHER||ROC AUC|0.923|||||ONE_SIDED|99.0|0.85|||||||Summary of ROC Analyses following macimorelin administration.|||0.850|
73864002|NCT00448747|147274242|OTHER|Sensitivity|sensitivity (percent)|82.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
74088720|NCT03465436|147730588|SUPERIORITY||LS Mean|0.43|||||TWO_SIDED|90.0|0.01|0.84|||Mixed Models Analysis|||24 hours postdose||0.84|0.01|
73864003|NCT00448747|147274242|OTHER|Specificity|Specificity (percent)|92.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
73864004|NCT00448747|147274242|OTHER|Misclassification|misclassification (percent)|13.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
73864005|NCT00448747|147274243|OTHER||Mean Difference (Final Values)|-5.1|STANDARD_DEVIATION|9.57|||TWO_SIDED|||||||||Summary of IGF-1 before and after AEZS-130 administration: post - pre differences||||
73864006|NCT00448747|147274243|OTHER||Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|16.25|||TWO_SIDED|||||||||||||
73864007|NCT04051827|147274256|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|1.03|||||TWO_SIDED|90.0|0.739|1.42|||||The geometric mean ratio (GMR) of midazolam Cmax on Day 24 (with mobocertinib) versus on Day 1 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam Cmax (in the presence vs absence of mobocertinib) and the associated 2-sided 90 percent (%) confidence intervals (CIs) were calculated on the basis of the within-patient variance using a mixed-effects analysis of variance (ANOVA) model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.42|0.739|
73864008|NCT04051827|147274257|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|0.676|||||TWO_SIDED|90.0|0.532|0.859|||||The GMR of midazolam AUC∞ on Day 24 (with mobocertinib) versus on Day 1 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam AUC∞ (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||0.859|0.532|
73864009|NCT04051827|147274258|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|1.3|||||TWO_SIDED|90.0|0.886|1.92|||||The GMR of midazolam Cmax on Day 25 (with mobocertinib) versus on Day 2 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam Cmax (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.92|0.886|
73864010|NCT04051827|147274259|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|0.837|||||TWO_SIDED|90.0|0.673|1.04|||||The GMR of midazolam AUC∞ on Day 25 (with mobocertinib) versus on Day 2 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam AUC∞ (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.04|0.673|
73864011|NCT01424566|147274265|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9173|TWO_SIDED|95.0|-0.42|0.38|||ANCOVA|||||0.38|-0.42|0.9173
73932429|NCT02033889|147394818|OTHER||Difference in the Least Squares Means|-0.21|||||TWO_SIDED|95.0|-0.78|0.35|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.35|-0.78|
73932430|NCT02033889|147394822|OTHER||Difference in the Least Squares Means|0.17|||||TWO_SIDED|95.0|-0.53|0.88|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.88|-0.53|
73932431|NCT02033889|147394822|OTHER||Difference in the Least Squares Means|-0.18|||||TWO_SIDED|97.0|-0.88|0.51|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.51|-0.88|
73932432|NCT02033889|147394823|OTHER||Difference in the Least Squares Means|0.25|||||TWO_SIDED|95.0|-0.48|0.98|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.98|-0.48|
74008239|NCT03627767|147566488|SUPERIORITY||Difference in percentage|45.5|||<|0.0001|TWO_SIDED|95.0|38.4|52.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||52.7|38.4|< 0.0001
73864012|NCT01985360|147274428|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.79|1.29||||||||1.29|0.79|
73864013|NCT04881747|147274441|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.875|||||TWO_SIDED|90.0|0.834|0.919||||||||0.919|0.834|
73864014|NCT04881747|147274441|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.889|||||TWO_SIDED|90.0|0.846|0.934||||||||0.934|0.846|
73864015|NCT04881747|147274442|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.944|||||TWO_SIDED|90.0|0.914|0.976||||||||0.976|0.914|
73864016|NCT04881747|147274442|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.946|||||TWO_SIDED|90.0|0.914|0.978||||||||0.978|0.914|
73864017|NCT04881747|147274443|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.941|||||TWO_SIDED|90.0|0.91|0.972||||||||0.972|0.910|
73932433|NCT02033889|147394823|OTHER||Difference in the Least Squares Means|0.2|||||TWO_SIDED|95.0|-0.51|0.91|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.91|-0.51|
74008240|NCT03627767|147566488|SUPERIORITY||Difference in percentage|16.0|||||TWO_SIDED|95.0|7.4|24.6||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.6|7.4|
73864018|NCT04881747|147274443|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.944|||||TWO_SIDED|90.0|0.913|0.977||||||||0.977|0.913|
73864019|NCT04598269|147274455|SUPERIORITY||Least Square Means (LSM) % Differences|-33.01|STANDARD_ERROR_OF_MEAN|8.971|<|0.001|TWO_SIDED|90.0|-47.95|-18.08||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|Mixed Model Repeated Measures (MMRM)||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Week 4: Least Square Means (LSM) % differences ATI-1777 arm minus vehicle arm"|||-18.08|-47.95|<0.001
73864020|NCT04598269|147274456|SUPERIORITY||LSM % Differences|-23.53|STANDARD_ERROR_OF_MEAN|8.971||0.005|TWO_SIDED|90.0|-38.47|-8.59||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|MMRM||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Day 8: LSM % differences ATI-1777 arm minus vehicle arm"|Day 8 statistical analysis||-8.59|-38.47|0.005
73932434|NCT02033889|147394824|OTHER||Difference in the Least Squares Means|-0.5|||||TWO_SIDED|95.0|-0.95|-0.04|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.04|-0.95|
73932435|NCT02033889|147394824|OTHER||Difference in the Least Squares Means|-0.22|||||TWO_SIDED|95.0|-0.66|0.23|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.23|-0.66|
73932436|NCT02033889|147394825|OTHER||Difference in the Least Squares Means|0.06|||||TWO_SIDED|95.0|-0.61|0.72|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.72|-0.61|
73932437|NCT02033889|147394825|OTHER||Difference in the Least Squares Means|-0.15|||||TWO_SIDED|95.0|-0.78|0.49|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.49|-0.78|
73932438|NCT02033889|147394829|OTHER||Difference in the Least Squares Means|-0.23|||||TWO_SIDED|95.0|-1.01|0.56|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.56|-1.01|
73932439|NCT02033889|147394829|OTHER||Difference in the Least Squares Means|-0.28|||||TWO_SIDED|97.0|-1.06|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.50|-1.06|
73932440|NCT02033889|147394830|OTHER||Difference in the Least Squares Means|0.27|||||TWO_SIDED|95.0|-0.58|1.13|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|1.13|-0.58|
74008241|NCT03627767|147566488|SUPERIORITY||Difference in percentage|19.9|||<|0.0001|TWO_SIDED|95.0|13.0|26.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.8|13.0|< 0.0001
73864021|NCT04598269|147274456|SUPERIORITY||LSM % Differences|-23.44|STANDARD_ERROR_OF_MEAN|8.971||0.005|TWO_SIDED|90.0|-38.38|-8.5||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|Mixed Models Analysis||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Day 15: LSM % differences ATI-1777 arm minus vehicle arm"|Day 15 statistical analysis||-8.50|-38.38|0.005
73932441|NCT02033889|147394830|OTHER||Difference in the Least Squares Means|0.12|||||TWO_SIDED|95.0|-0.7|0.93|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.93|-0.70|
73932442|NCT02033889|147394831|OTHER||Difference in the Least Squares Means|-0.84|||||TWO_SIDED|95.0|-1.44|-0.24|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.24|-1.44|
73932443|NCT02033889|147394831|OTHER||Difference in the least Squares Means|-0.54|||||TWO_SIDED|95.0|-1.12|0.05|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.05|-1.12|
73932444|NCT02033889|147394832|OTHER||Difference in the Least Squares Means|-0.06|||||TWO_SIDED|95.0|-0.77|0.65|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.65|-0.77|
73932445|NCT02033889|147394832|OTHER||Difference in the Least Squares Means|0.18|||||TWO_SIDED|95.0|-0.5|0.85|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.85|-0.50|
74088721|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.19|||||TWO_SIDED|90.0|-0.59|0.21|||Mixed Models Analysis|||30 minutes postdose||0.21|-0.59|
74088722|NCT03465436|147730588|SUPERIORITY||LS Mean|0.48|||||TWO_SIDED|90.0|0.06|0.89|||Mixed Models Analysis|||1 hour postdose||0.89|0.06|
73864022|NCT04598269|147274457|SUPERIORITY||Odds Ratio, log|15.7|||<|0.001|TWO_SIDED|90.0|3.9|63.2||1-sided p-value of responders in the treatment groups at 0.05 level of significance.|Regression, Logistic||Active/Vehicle|||63.2|3.9|<0.001
73864023|NCT04598269|147274458|SUPERIORITY||Odds Ratio, log|5.9||||0.003|TWO_SIDED|90.0|2.1|17.0||1-sided p-value of responders in the treatment groups at 0.05 level of significance|Regression, Linear||Active/Vehicle|||17.0|2.1|0.003
73864024|NCT04598269|147274459|SUPERIORITY||Odds Ratio, log|1.7||||0.203|TWO_SIDED|90.0|0.6|5.3||1-sided p-value of responders in the treatment groups at 0.05 level of significance|Regression, Logistic||Active/Vehicle|||5.3|0.6|0.203
73864025|NCT04598269|147274460|SUPERIORITY|||||||0.148||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.148
73864026|NCT04598269|147274460|SUPERIORITY|||||||0.017||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.017
73864027|NCT04598269|147274460|SUPERIORITY|||||||0.002||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Week 4 statistical analysis||||0.002
73864028|NCT04598269|147274461|SUPERIORITY|||||||0.088||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.088
73864029|NCT04598269|147274461|SUPERIORITY|||||||0.022||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.022
73864030|NCT04598269|147274461|SUPERIORITY||||||<|0.001||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance.|MMRM|||Week 4 statistical analysis||||<0.001
73864031|NCT04598269|147274462|SUPERIORITY|||||||0.014||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.014
73864032|NCT04598269|147274462|SUPERIORITY|||||||0.069||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.069
73864033|NCT04598269|147274462|SUPERIORITY|||||||0.06||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Week 4 statistical analysis||||0.060
73864034|NCT02598128|147274482|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|The independent variables in the mixed model analysis included fixed effect factors for treatment (placebo or RELiZORB).||||||<0.001
73864035|NCT01064687|147274498|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.22|-0.88||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.88|-1.22|<0.001
73864036|NCT01064687|147274498|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.39|-0.66|<0.0001
73864037|NCT01064687|147274498|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.84|||<|0.001|TWO_SIDED|95.0|-1.01|-0.67||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.67|-1.01|<0.001
73864038|NCT01064687|147274498|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.66|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.39|-0.66|<0.001
73864039|NCT01064687|147274498|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.18|-0.44|<0.001
73864040|NCT01064687|147274498|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.18|-0.44|<0.001
73864041|NCT01064687|147274499|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.39|-0.73|<0.001
73864042|NCT01064687|147274499|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.11|-0.44|<0.001
73864043|NCT01064687|147274499|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.39|-0.73|<0.001
73864044|NCT01064687|147274499|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.11|-0.44|<0.001
73864045|NCT01064687|147274500|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.72|||<|0.001|TWO_SIDED|95.0|-3.58|-1.85|||Mixed Models Analysis|||||-1.85|-3.58|<0.001
73864046|NCT01064687|147274500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.571|TWO_SIDED|95.0|-0.88|0.49|||Mixed Models Analysis|||||0.49|-0.88|0.571
73864047|NCT01064687|147274500|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.19||||0.007|TWO_SIDED|95.0|-2.06|-0.33|||Mixed Models Analysis|||||-0.33|-2.06|0.007
74088723|NCT03465436|147730588|SUPERIORITY||LS Mean|0.56|||||TWO_SIDED|90.0|0.19|0.93|||Mixed Models Analysis|||1.5 hours postdose||0.93|0.19|
73864048|NCT01064687|147274500|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|||<|0.001|TWO_SIDED|95.0|0.64|2.01|||Mixed Models Analysis|||||2.01|0.64|<0.001
73864049|NCT01064687|147274500|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.52|||<|0.001|TWO_SIDED|95.0|-3.39|-1.65|||Mixed Models Analysis|||||-1.65|-3.39|<0.001
73864050|NCT01064687|147274501|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.507|TWO_SIDED|95.0|-1.25|0.62|||Mixed Models Analysis|||||0.62|-1.25|0.507
73864051|NCT01064687|147274501|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25||||0.009|TWO_SIDED|95.0|0.32|2.19|||Mixed Models Analysis|||||2.19|0.32|0.009
73864052|NCT01064687|147274502|SUPERIORITY_OR_OTHER||LS Means Difference|-0.97|||<|0.001|TWO_SIDED|95.0|-1.27|-0.67|||Mixed Models Analysis|||||-0.67|-1.27|<0.001
73864053|NCT01064687|147274502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.568|TWO_SIDED|95.0|-0.31|0.17|||Mixed Models Analysis|||||0.17|-0.31|0.568
73864054|NCT01064687|147274502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42||||0.006|TWO_SIDED|95.0|-0.72|-0.12|||Mixed Models Analysis|||||-0.12|-0.72|0.006
73864055|NCT01064687|147274502|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.24|0.71|||Mixed Models Analysis|||||0.71|0.24|<0.001
73864056|NCT01064687|147274502|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.2|-0.6|||Mixed Models Analysis|||||-0.60|-1.20|<0.001
73864057|NCT01064687|147274503|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.58|TWO_SIDED|95.0|-0.42|0.23|||Mixed Models Analysis|||||0.23|-0.42|0.580
73864058|NCT01064687|147274503|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.005|TWO_SIDED|95.0|0.14|0.79|||Mixed Models Analysis|||||0.79|0.14|0.005
73864059|NCT01064687|147274504|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.76|||<|0.001|TWO_SIDED|95.0|-34.5|-23.02|||Mixed Models Analysis|||||-23.02|-34.50|<0.001
73864060|NCT01064687|147274504|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.34|||<|0.001|TWO_SIDED|95.0|-13.62|-5.06|||Mixed Models Analysis|||||-5.06|-13.62|<0.001
73932446|NCT02873923|147394843|OTHER||Correlation coefficient|0.66|||||TWO_SIDED|95.0|0.63|0.68|||||||As of today, the meta-analytic surrogacy evaluation scheme proposed by Buyse and Burzykowski et al. is considered as the most statistically rigorous method for the validation of surrogate endpoints. This approach requires individual-patient data (IPD) from multiple randomized clinical trials (RCT) with similar design and treatment to address surrogacy from a multi-level framework. At the patient level, the surrogate endpoint should be correlated and predictive of the final endpoint regardless of the treatment (individual level association). At the trial level, the treatment effect on the surrogate endpoint should be correlated and predictive of the treatment effect on the final endpoint (trial-level association). Individual-level and trial-level associations estimated using weighted linear regression and the two-stage model introduced by Buyse and Burzykowski.|0.68|0.63|
73932447|NCT02873923|147394844|OTHER||correlation coefficient|0.0|||||TWO_SIDED|95.0|0.0|0.005|||||||As of today, the meta-analytic surrogacy evaluation scheme proposed by Buyse and Burzykowski et al. is considered as the most statistically rigorous method for the validation of surrogate endpoints. This approach requires individual-patient data (IPD) from multiple randomized clinical trials (RCT) with similar design and treatment to address surrogacy from a multi-level framework. At the patient level, the surrogate endpoint should be correlated and predictive of the final endpoint regardless of the treatment (individual level association). At the trial level, the treatment effect on the surrogate endpoint should be correlated and predictive of the treatment effect on the final endpoint (trial-level association). Individual-level and trial-level associations estimated using weighted linear regression and the two-stage model introduced by Buyse and Burzykowski.|0.005|0.00|
73932448|NCT01610700|147394845|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.93||||0.124||95.0|-13.52|1.65|||ANCOVA|||The change in the primary impairment was compared between treatment groups using analysis of covariance (ANCOVA) with baseline primary impairment score as the covariate.||1.65|-13.52|0.124
74030190|NCT00637273|147614308|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|3.3||0.0814|TWO_SIDED|95.0|0.3|13.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||13.2|0.3|0.0814
74030191|NCT00637273|147614309|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9546|TWO_SIDED|95.0|-1.6|1.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||1.5|-1.6|0.9546
74088724|NCT03465436|147730588|SUPERIORITY||LS Mean|0.4|||||TWO_SIDED|90.0|0.02|0.77|||Mixed Models Analysis|||2 hours postdose||0.77|0.02|
74088725|NCT03465436|147730588|SUPERIORITY||LS Mean|0.51|||||TWO_SIDED|90.0|0.13|0.88|||Mixed Models Analysis|||2.5 hours postdose||0.88|0.13|
73864061|NCT01064687|147274504|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.02|||<|0.001|TWO_SIDED|95.0|-29.8|-18.24|||Mixed Models Analysis|||||-18.24|-29.80|<0.001
73864062|NCT01064687|147274504|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.61||||0.038|TWO_SIDED|95.0|-8.95|-0.27|||Mixed Models Analysis|||||-0.27|-8.95|0.038
73864063|NCT01064687|147274504|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.41|||<|0.001|TWO_SIDED|95.0|-25.18|-13.65|||Mixed Models Analysis|||||-13.65|-25.18|<0.001
73864064|NCT01064687|147274505|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.68||||0.004|TWO_SIDED|95.0|-12.84|-2.52|||Mixed Models Analysis|||||-2.52|-12.84|0.004
73864065|NCT01064687|147274505|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.47||||0.092|TWO_SIDED|95.0|-9.66|0.73|||Mixed Models Analysis|||||0.73|-9.66|0.092
73864066|NCT01064687|147274506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.1|||<|0.001|TWO_SIDED|95.0|7.4|23.4||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||23.4|7.4|<0.001
73864067|NCT01064687|147274506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|3.9|10.1||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||10.1|3.9|<0.001
73864068|NCT01064687|147274506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.001|TWO_SIDED|95.0|2.8|8.0||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||8.0|2.8|<0.001
73864069|NCT01064687|147274506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.5|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||3.5|1.5|<0.001
73864070|NCT01064687|147274506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.004|TWO_SIDED|95.0|1.3|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||3.5|1.3|0.004
73864071|NCT01064687|147274506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.8|||<|0.001|TWO_SIDED|95.0|6.7|20.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||20.8|6.7|<0.001
73864072|NCT01064687|147274506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.9|6.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||6.8|2.9|<0.001
73864073|NCT01064687|147274506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.3|||<|0.001|TWO_SIDED|95.0|3.7|10.9||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||10.9|3.7|<0.001
73864074|NCT01064687|147274506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.6|3.5||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||3.5|1.6|<0.001
73864075|NCT01064687|147274506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.6|4.6||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||4.6|1.6|<0.001
73864076|NCT01064687|147274507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.001|TWO_SIDED|95.0|2.4|5.6||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||5.6|2.4|<0.001
73864077|NCT01064687|147274507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.008|TWO_SIDED|95.0|1.1|2.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||2.5|1.1|0.008
73864078|NCT01064687|147274507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.3|5.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||5.1|2.3|<0.001
73864079|NCT01064687|147274507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.4|3.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||3.1|1.4|<0.001
73864080|NCT01064687|147274508|SUPERIORITY_OR_OTHER||LS Mean Difference|35.21|||<|0.001|TWO_SIDED|95.0|27.26|43.16||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||43.16|27.26|<0.001
73864081|NCT01064687|147274508|SUPERIORITY_OR_OTHER||LS Mean Difference|21.12|||<|0.001|TWO_SIDED|95.0|14.97|27.28||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||27.28|14.97|<0.001
73932449|NCT01610700|147394846|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.1||||0.062|TWO_SIDED|95.0|-14.56|0.37|||ANCOVA|||The change in the spasticity visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.37|-14.56|0.062
73932450|NCT01610700|147394847|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.88||||0.731|TWO_SIDED|95.0|-12.73|8.96|||ANCOVA|||The change in the pain visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||8.96|-12.73|0.731
73932451|NCT01610700|147394848|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-3.3||||0.443|TWO_SIDED|95.0|-11.82|5.21|||ANCOVA|||The change in the muscle spasm visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||5.21|-11.82|0.443
73864082|NCT01064687|147274508|SUPERIORITY_OR_OTHER||LS Mean Difference|22.68|||<|0.001|TWO_SIDED|95.0|14.63|30.72||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||30.72|14.63|<0.001
73932452|NCT01610700|147394849|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-6.85||||0.311|TWO_SIDED|95.0|-20.31|6.6|||ANCOVA|||The change in the tremor visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||6.60|-20.31|0.311
73864083|NCT01064687|147274508|SUPERIORITY_OR_OTHER||LS Mean Difference|8.59||||0.007|TWO_SIDED|95.0|2.31|14.87||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||14.87|2.31|0.007
73864084|NCT01064687|147274508|SUPERIORITY_OR_OTHER||LS Mean Difference|14.09|||<|0.001|TWO_SIDED|95.0|6.06|22.11||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||22.11|6.06|<0.001
73864085|NCT01064687|147274508|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.7||||0.207|TWO_SIDED|95.0|-14.56|3.17||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||3.17|-14.56|0.207
73864086|NCT01064687|147274508|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54||||0.659|TWO_SIDED|95.0|-8.41|5.32||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||5.32|-8.41|0.659
73864087|NCT01064687|147274508|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4||||0.759|TWO_SIDED|95.0|-10.37|7.56||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||7.56|-10.37|0.759
73864088|NCT01064687|147274508|SUPERIORITY_OR_OTHER||LS Mean Difference|2.75||||0.441|TWO_SIDED|95.0|-4.25|9.76||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||9.76|-4.25|0.441
73864089|NCT01064687|147274508|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.15||||0.362|TWO_SIDED|95.0|-13.1|4.79||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||4.79|-13.10|0.362
73864090|NCT01064687|147274509|SUPERIORITY_OR_OTHER||LS Mean Difference|21.64|||<|0.001|TWO_SIDED|95.0|15.2|28.08||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||28.08|15.20|<0.001
73864091|NCT01064687|147274509|SUPERIORITY_OR_OTHER||LS Mean Difference|12.12|||<|0.001|TWO_SIDED|95.0|5.56|18.68||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||18.68|5.56|<0.001
73864092|NCT01064687|147274509|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.73||||0.307|TWO_SIDED|95.0|-10.9|3.43||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||3.43|-10.90|0.307
73864093|NCT01064687|147274509|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.75||||0.638|TWO_SIDED|95.0|-9.05|5.55||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||5.55|-9.05|0.638
73932453|NCT01610700|147394850|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.26|STANDARD_ERROR_OF_MEAN|4.36||0.154|TWO_SIDED|95.0|-14.9|2.38|||ANCOVA|||The change in bladder problems visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.38|-14.90|0.154
73932454|NCT01610700|147394851|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.293|TWO_SIDED|95.0|0.77|2.43|||Fisher Exact|||The proportion of subjects with better/much better assessments was compared between groups using a Fisher's Exact Test.||2.43|0.77|0.293
74088726|NCT03465436|147730588|SUPERIORITY||LS Mean|0.33|||||TWO_SIDED|90.0|-0.05|0.71|||Mixed Models Analysis|||3 hours postdose||0.71|-0.05|
74088727|NCT03465436|147730588|SUPERIORITY||LS Mean|0.32|||||TWO_SIDED|90.0|-0.02|0.67|||Mixed Models Analysis|||3.5 hours postdose||0.67|-0.02|
73864094|NCT00552409|147274553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||||TWO_SIDED|95.0|-56.0|251.0|||Regression, Linear||Mean urine ACR on treatment was 17% lower among participants assigned to cholecalciferol, compared to participants assigned to placebo, adjusted for baseline values.|||251|-56|
74030192|NCT00637273|147614309|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|2.6|5.7||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||5.7|2.6|<.0001
73864095|NCT00849108|147274635|SUPERIORITY_OR_OTHER||sensitivity|0.769||||0.02|TWO_SIDED|95.0|0.655|0.884||P-Value for sensitivity comparison of PET MPI for the same reader|McNemar|two-sided McNemar test with 1 degree of freedom.|No standard deviation can be calculated for PET sensitivity|||0.884|0.655|0.02
73864096|NCT00849108|147274635|SUPERIORITY_OR_OTHER||Sensitivity|0.596||||0.02|TWO_SIDED|95.0|0.463|0.73||p-value for sensitivity comparison for SPECT MPI for the same reader|McNemar||No standard deviation can be calculated for SPECT sensitivity|||0.730|0.463|0.02
73864097|NCT00849108|147274637|SUPERIORITY_OR_OTHER||PET specificity|0.877||||0.317|TWO_SIDED|95.0|0.801|0.952||p-value for comparison of PET specificity for same reader|McNemar||no standard deviation for PET specficity|||0.952|0.801|0.317
73864098|NCT00849108|147274637|SUPERIORITY_OR_OTHER||SPECT specificity|0.836||||0.317|TWO_SIDED|95.0|0.751|0.921||p-value for comparison of SPECT specificity for same reader|McNemar||no standard deviation for SPECT specificity|||0.921|0.751|0.317
73864099|NCT01563172|147274638|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|6.95||||0.0008|TWO_SIDED|95.0|2.91|10.98||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from Analysis of variance (ANOVA) with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||10.98|2.91|0.0008
73864100|NCT01563172|147274639|SUPERIORITY_OR_OTHER||LS mean difference|5.7||||0.0049|TWO_SIDED|95.0|1.74|9.66||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||9.66|1.74|0.0049
73864101|NCT01563172|147274640|SUPERIORITY_OR_OTHER||LS mean difference|-10.86|||<|0.0001|TWO_SIDED|95.0|-14.77|-6.94||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-6.94|-14.77|<0.0001
73864102|NCT01563172|147274641|SUPERIORITY_OR_OTHER||LS mean difference|-9.61|||<|0.0001|TWO_SIDED|95.0|-13.68|-5.54||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-5.54|-13.68|<0.0001
73864103|NCT01563172|147274642|SUPERIORITY_OR_OTHER||LS mean difference|15.38|||<|0.0001|TWO_SIDED|95.0|11.45|19.31||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||19.31|11.45|<0.0001
73864104|NCT01563172|147274643|SUPERIORITY_OR_OTHER||LS Mean Difference|514.01|||<|0.0001|TWO_SIDED|95.0|283.02|744.99||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||744.99|283.02|<0.0001
73864105|NCT01563172|147274644|SUPERIORITY_OR_OTHER||LS Mean difference|265.92||||0.0218|TWO_SIDED|95.0|39.0|492.83||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||492.83|39.00|0.0218
73864106|NCT01563172|147274645|SUPERIORITY_OR_OTHER||LS mean difference|-822.88|||<|0.0001|TWO_SIDED|95.0|-1047.34|-598.42||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-598.42|-1047.34|<0.0001
73932455|NCT01610700|147394853|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.69||||0.45|TWO_SIDED|95.0|-1.11|2.5|||ANCOVA|||The change from baseline in the mean Beck's Depression Inventory score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.50|-1.11|0.450
73932456|NCT01610700|147394854|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.12||||0.427|TWO_SIDED|95.0|-0.43|0.18|||ANCOVA|||The change baseline in the mean Fatigue Severity Scale Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.18|-0.43|0.427
74030193|NCT00637273|147614310|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.04||0.9718|TWO_SIDED|95.0|0.93|1.08||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||1.08|0.93|0.9718
73864107|NCT01563172|147274646|SUPERIORITY_OR_OTHER||LS mean difference|-574.79|||<|0.0001|TWO_SIDED|95.0|-808.08|-341.5||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-341.50|-808.08|<0.0001
73864108|NCT01563172|147274647|SUPERIORITY_OR_OTHER||LS mean difference|1294.34|||<|0.0001|TWO_SIDED|95.0|1069.24|1519.43||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||1519.43|1069.24|<0.0001
73864109|NCT02014584|147274649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.27|TWO_SIDED|95.0|-4.7|18.8|||Fisher's Exact Test|||||18.8|-4.7|0.27
73864110|NCT02014584|147274695|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.5||||0.62|TWO_SIDED|95.0|-10.4|3.4|||Fisher's Exact Test||DB Week 4|||3.4|-10.4|0.62
73864111|NCT02014584|147274695|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.4||||0.34|TWO_SIDED|95.0|-4.7|17.6|||Fisher's Exact Test||DB Week 12|||17.6|-4.7|0.34
74030194|NCT00637273|147614310|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.035||0.0062|TWO_SIDED|95.0|0.82|0.96||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||0.96|0.82|0.0062
74030195|NCT04392011|147614360|OTHER||AUC ratio (geometric mean)|1.39|||||TWO_SIDED|90.0|1.23|1.57||||||||1.57|1.23|
74030196|NCT04392011|147614361|OTHER||AUC ratio (geometric mean)|0.99|||||TWO_SIDED|90.0|0.83|1.19||||||||1.19|0.83|
73864112|NCT02014584|147274695|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.3||||0.31|TWO_SIDED|95.0|-4.2|16.7|||Fisher's Exact Test||DB Week 24|||16.7|-4.2|0.31
73864113|NCT02014584|147274697|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.8||0.082|TWO_SIDED|95.0|-0.2|3.0|||t-test from general linear model||DB Week 4|||3.0|-0.2|0.082
73864114|NCT02014584|147274697|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.09||0.25|TWO_SIDED|95.0|-3.4|0.9|||t-test from general linear model||DB Week 12|||0.9|-3.4|0.25
73864115|NCT02014584|147274697|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.04||0.99|TWO_SIDED|95.0|-2.0|2.1|||t-test from general linear model||DB Week 24|||2.1|-2.0|0.99
73864116|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.46|TWO_SIDED|95.0|-0.4|0.9|||t-test from general linear model||Erectile Function DB Week 4|||0.9|-0.4|0.46
74030197|NCT04392011|147614363|OTHER||Cmax ratio (midazolam)|1.5|||||TWO_SIDED|90.0|1.32|1.7||||||||1.70|1.32|
74030198|NCT04392011|147614363|OTHER||Cmax ratio (dextromethorphan)|0.96|||||TWO_SIDED|90.0|0.78|1.19||||||||1.19|0.78|
74030199|NCT04392011|147614365|OTHER||half-life ratio (dextromethorphan)|1.0|||||TWO_SIDED|90.0|0.92|1.08||||||||1.08|0.92|
74030200|NCT04392011|147614365|OTHER||half-life ratio (midazolam)|1.07|||||TWO_SIDED|90.0|0.98|1.17||||||||1.17|0.98|
74030201|NCT00477451|147614459|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
74030202|NCT00477451|147614460|SUPERIORITY|||||||0.368|||||||Wilcoxon (Mann-Whitney)|||||||0.368
74030203|NCT00477451|147614461|SUPERIORITY|||||||0.207|||||||t-test, 2 sided|||||||0.207
73864117|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.52||0.14|TWO_SIDED|95.0|-1.8|0.3|||t-test from general linear model||Erectile Function DB Week 12|||0.3|-1.8|0.14
73864118|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61||0.27|TWO_SIDED|95.0|-1.9|0.5|||t-test from general linear model||Erectile Function DB Week 24|||0.5|-1.9|0.27
73864119|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.13|TWO_SIDED|95.0|-0.1|0.8|||t-test from general linear model||Intercourse satisfaction DB Week 4|||0.8|-0.1|0.13
73864120|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.73|TWO_SIDED|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 12|||0.5|-0.8|0.73
73864121|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.64|TWO_SIDED|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 24|||0.5|-0.8|0.64
74030204|NCT04172831|147614499|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.01|TWO_SIDED|95.0|-0.7|-0.1|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.1|-0.7|0.010
74030205|NCT04172831|147614500|SUPERIORITY||Odds Ratio (OR)|1.44||||0.058|TWO_SIDED|95.0|0.99|2.1|||Regression, Logistic|||||2.10|0.99|0.058
74030206|NCT04172831|147614501|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|1.6||0.007|TWO_SIDED|95.0|-7.5|-1.2|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.2|-7.5|0.007
74030207|NCT04172831|147614502|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.69||0.009|TWO_SIDED|95.0|-7.7|-1.1|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.1|-7.7|0.009
74030208|NCT04172831|147614503|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-4.5|-1.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.3|-4.5|<0.001
74030209|NCT04172831|147614504|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.76||0.018|TWO_SIDED|95.0|-3.3|-0.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.3|-3.3|0.018
74030210|NCT04172831|147614505|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.3|-0.9|<0.001
74030211|NCT01041573|147614506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641|||||||Fisher Exact|||||||0.641
74030212|NCT01041573|147614506|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
74030213|NCT01276847|147614515|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.016
73864122|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED|95.0|-0.1|0.5|||t-test from general linear model||Orgasmic function DB Week 4|||0.5|-0.1|0.23
73864123|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.33|TWO_SIDED|95.0|-0.5|0.2|||t-test from general linear model||Orgasmic function DB Week 12|||0.2|-0.5|0.33
73864124|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.23||0.64|TWO_SIDED|95.0|-0.6|0.3|||t-test from general linear model||Orgasmic function DB Week 24|||0.3|-0.6|0.64
73864125|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.19|TWO_SIDED|95.0|-0.1|0.7|||t-test from general linear model||Sexual desire DB Week 4|||0.7|-0.1|0.19
73864126|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.28|TWO_SIDED|95.0|-0.7|0.2|||t-test from general linear model||Sexual desire DB Week 12|||0.2|-0.7|0.28
73864127|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||1|TWO_SIDED|95.0|-0.5|0.5|||t-test from general linear model||Sexual desire DB Week 24|||0.5|-0.5|1.00
73864128|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.28|TWO_SIDED|95.0|-0.2|0.5|||t-test from general linear model||Overall sexual satisfaction DB Week 4|||0.5|-0.2|0.28
73864129|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.64|TWO_SIDED|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 12|||0.3|-0.5|0.64
73864130|NCT02014584|147274699|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.69|TWO_SIDED|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 24|||0.3|-0.5|0.69
73864131|NCT02014584|147274701|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.1|STANDARD_ERROR_OF_MEAN|1.14||0.33|TWO_SIDED|95.0|-1.1|3.4|||t-test from general linear model||DB Week 12|||3.4|-1.1|0.33
73864132|NCT02014584|147274701|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.14||0.004|TWO_SIDED|95.0|1.1|5.6|||t-test from general linear model||DB Week 24|||5.6|1.1|0.004
74030214|NCT01276847|147614515|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.007
73864133|NCT02014584|147274703|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.22|TWO_SIDED|95.0|-1.7|0.4|||t-test from general linear model||DB Week 12|||0.4|-1.7|0.22
73864134|NCT02014584|147274703|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.76||0.5|TWO_SIDED|95.0|-2.0|1.0|||t-test from general linear model||DB Week 24|||1.0|-2.0|0.50
73864135|NCT00752726|147274713|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.263|STANDARD_ERROR_OF_MEAN|0.115||0.0244|TWO_SIDED|95.0|0.035|0.491||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for treatment, baseline VAT and center effect using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined. For this primary analysis, only one statistical test was performed and therefore, no multiple comparison adjustment was done.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||0.491|0.035|0.0244
74030215|NCT01276847|147614515|SUPERIORITY_OR_OTHER|||||||0.00015||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.00015
73864136|NCT00752726|147274714|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.172|STANDARD_ERROR_OF_MEAN|0.0834||0.0415|TWO_SIDED|95.0|0.007|0.337||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline VAT and center effects using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 12 between the two treatment groups.||0.337|0.007|0.0415
73864137|NCT00752726|147274715|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.99|STANDARD_ERROR_OF_MEAN|0.881||0.026|TWO_SIDED|95.0|0.25|3.74||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline weight and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.74|0.25|0.026
73864138|NCT00752726|147274716|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.642|STANDARD_ERROR_OF_MEAN|0.7174||0.0242|TWO_SIDED|95.0|0.219|3.065||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.065|0.219|0.0242
73864139|NCT00752726|147274717|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.47|STANDARD_ERROR_OF_MEAN|0.704||0.039|TWO_SIDED|95.0|0.07|2.87||P-value was not adjusted for multiple comparisons|ANCOVA|Mean was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||2.87|0.07|0.039
73932457|NCT01610700|147394856|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.72||||0.647|TWO_SIDED|95.0|-2.38|3.82|||ANCOVA|||The change from baseline in the mean total 28-item General Health Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||3.82|-2.38|0.647
74030216|NCT01276847|147614515|SUPERIORITY_OR_OTHER|||||||0.000184||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.000184
73864140|NCT00752726|147274718|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.974||0.085|TWO_SIDED|95.0|-0.24|3.63||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline waist circumference and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.63|-0.24|0.085
74030217|NCT01276847|147614516|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.397
74030218|NCT01276847|147614516|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.010
73864141|NCT00752726|147274720|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.0232||0.3235|TWO_SIDED|95.0|-0.069|0.023||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline liver fat and center effects, using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||0.023|-0.069|0.3235
73864142|NCT00752726|147274721|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|783.8|STANDARD_ERROR_OF_MEAN|726.54||0.28|TWO_SIDED|95.0|-657.3|2224.9||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline total calories expended and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||2224.9|-657.3|0.28
73864143|NCT00752726|147274722|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|1.542||0.2847|TWO_SIDED|95.0|-1.4|4.72||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean difference was adjusted for the treatment, baseline value and center effects using an ANCOVA model.|Adjusted mean difference was calculated as placebo minus orlistat.|The null hypothesis considered no difference in the change from baseline to week 24 between the treatment groups.||4.72|-1.40|0.2847
73864144|NCT04232215|147274731|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.64|TWO_SIDED|95.0|-10.2|6.1|||Regression, Linear|A generalized linear model adjusting by intervention group and the order of randomization was conducted.||Difference in ease of use between our standard fetal Doppler and HeraBEAT™ device, as measured by the System Usability Survey (SUS) will be the primary outcome. We aim to recruit 50 participants (50 per arm, with cross-over) for a 99.7% power to detect a 10-point difference in SUS, as this accounts for a withdraw / post-randomization exclusion as high as 10% (assuming a proportion of expectant mothers to withdraw participation after being enrolled or found to not meet criteria after the fact).||6.1|-10.2|0.64
73864145|NCT04232215|147274732|SUPERIORITY||Risk Ratio (RR)|1.2||||0.63|TWO_SIDED|95.0|0.57|2.53|||Chi-squared|||||2.53|0.57|0.63
73864146|NCT01555125|147274743|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73864147|NCT01555125|147274743|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73864148|NCT01555125|147274744|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73864149|NCT01555125|147274744|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73864150|NCT02651220|147274766|EQUIVALENCE|Bioequivalence was based on 90% confidence interval within 80-125%.|Bioavailability|100.28|||||TWO_SIDED|90.0|96.78|103.91||||||||103.91|96.78|
73864151|NCT02651220|147274767|EQUIVALENCE|Bioequivalence is based on 90% confidence interval within 80-125%.|Bioavailability|99.73|||||TWO_SIDED|90.0|96.04|103.56||||||||103.56|96.04|
74030219|NCT01276847|147614516|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.002
73864152|NCT02651220|147274768|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73864153|NCT00896441|147274769|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|One sample t-test||||||<0.01
73864154|NCT00896441|147274771|OTHER||||||<|0.006|||||||t-test, 2 sided|Single group t-test||||||<.006
73864155|NCT01304589|147274772|SUPERIORITY_OR_OTHER|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||.001
73864156|NCT01304589|147274773|SUPERIORITY_OR_OTHER|||||||0.003||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|paired T-test|"Subjects completed a tampon insertion pain test once a week. The values were averaged and compared pre-treatment versus post-treatment."||||||.003
74030220|NCT01276847|147614516|SUPERIORITY_OR_OTHER|||||||0.000215||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.000215
73864157|NCT01304589|147274774|SUPERIORITY_OR_OTHER|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||.001
73864158|NCT01304589|147274775|SUPERIORITY_OR_OTHER||||||<|0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||<.001
74030221|NCT01276847|147614517|SUPERIORITY_OR_OTHER|||||||0.787||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.787
73864159|NCT01439373|147274808|OTHER||Mean posterior difference|0.46|STANDARD_DEVIATION|0.119|||||||||Bayesian probability model|"P1= P(p805 \>pPLC +0.3 \| data)= 0.905. A probability of 95% (P1 \> 0.95) or greater was to be considered 'substantial evidence of superiority."|Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.22 to 0.68.|||||
73864160|NCT01439373|147274809|OTHER||Mean posterior difference|0.41|STANDARD_DEVIATION|0.122|||||||||Bayesian probability model|"P1= P(p805 \>pPLC +0.3 \| data)= 0.822. A probability of 95% (P1 \> 0.95) or greater was to be considered 'substantial evidence of superiority."|Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.17 to 0.6|||||
73864161|NCT01078168|147274828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3769||||0.0347|TWO_SIDED|95.0|0.03025|0.7235||threshold: p\<0.05|t-test, 2 sided|||||0.7235|0.03025|0.0347
73864162|NCT01280695|147274833|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.0||||0.4195|TWO_SIDED|95.0|-34.0|14.0|||Wilcoxon (Mann-Whitney)|||||14.0|-34.0|0.4195
73864163|NCT01280695|147274833|SUPERIORITY_OR_OTHER||Median Difference (Net)|-18.0||||0.0811|TWO_SIDED|95.0|-38.0|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|-38.0|0.0811
74030222|NCT01276847|147614517|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.577
74030223|NCT01276847|147614517|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.053
73864164|NCT01280695|147274833|SUPERIORITY_OR_OTHER||Median Difference (Net)|-20.0||||0.0639|TWO_SIDED|95.0|-38.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|-38.0|0.0639
73864165|NCT01280695|147274833|SUPERIORITY_OR_OTHER||Median Difference (Net)|-32.0||||0.0022|TWO_SIDED|95.0|-50.0|-12.0|||Wilcoxon (Mann-Whitney)|||||-12.0|-50.0|0.0022
73864166|NCT02905006|147274843|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
73864167|NCT02905006|147274843|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
73864168|NCT02905006|147274843|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
73864169|NCT02905006|147274843|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
73864170|NCT02905006|147274844|SUPERIORITY||Odds Ratio (OR)|21.43|||=|0.0001|TWO_SIDED|95.0|4.51|101.88|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||101.88|4.51|=0.0001
74030224|NCT01276847|147614517|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.098
73864171|NCT02905006|147274844|SUPERIORITY||Odds Ratio (OR)|63.21|||<|0.0001|TWO_SIDED|95.0|12.9|309.83|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||309.83|12.90|<0.0001
73864172|NCT02905006|147274844|SUPERIORITY||Odds Ratio (OR)|62.35|||<|0.0001|TWO_SIDED|95.0|12.61|308.29|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||308.29|12.61|<0.0001
73864173|NCT02905006|147274844|SUPERIORITY||Odds Ratio (OR)|130.35|||<|0.0001|TWO_SIDED|95.0|24.5|693.51|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||693.51|24.50|<0.0001
73864174|NCT02905006|147274844|SUPERIORITY||Odds Ratio (OR)|69.4|||<|0.0001|TWO_SIDED|95.0|14.07|342.4|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||342.40|14.07|<0.0001
73864175|NCT02905006|147274845|SUPERIORITY||Odds Ratio (OR)|18.23|||=|0.0003|TWO_SIDED|95.0|3.79|87.76|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||87.76|3.79|=0.0003
73864176|NCT02905006|147274845|SUPERIORITY||Odds Ratio (OR)|39.6|||<|0.0001|TWO_SIDED|95.0|8.19|191.59|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||191.59|8.19|<0.0001
73864177|NCT02905006|147274845|SUPERIORITY||Odds Ratio (OR)|77.27|||<|0.0001|TWO_SIDED|95.0|15.19|392.93|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||392.93|15.19|<0.0001
73971641|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-7.021||||0.028|TWO_SIDED|95.0|-13.278|-0.763|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-0.763|-13.278|0.0280
74030225|NCT02222129|147614534|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed using SAS, version 9.2 (Statistical Analysis Software, Cary, NC). All power calculations were at the 80% level with an alpha of 0.05. Based upon opioid consumption data previously reported for robotic-assisted laparoscopic prostatectomy, a sample size of 74 would be necessary to detect a 10 mg difference in morphine equivalents totaled over the entire hospital stay. (Webster TM, Herrell SD, Chang SS, et al. The Journal of Urology 2005;174(3):912-914.||||0.39
73864178|NCT02905006|147274845|SUPERIORITY||Odds Ratio (OR)|141.99|||<|0.0001|TWO_SIDED|95.0|26.26|767.72|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||767.72|26.26|<0.0001
73864179|NCT02905006|147274845|SUPERIORITY||Odds Ratio (OR)|58.52|||<|0.0001|TWO_SIDED|95.0|11.89|288.0|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||288.00|11.89|<0.0001
73864180|NCT02905006|147274846|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
73864181|NCT02905006|147274846|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
73864182|NCT02905006|147274846|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
73864183|NCT02905006|147274846|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
73864184|NCT02905006|147274846|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
73864185|NCT02905006|147274847|SUPERIORITY||Odds Ratio (OR)|32.65|||<|0.0001|TWO_SIDED|95.0|6.82|156.38|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||156.38|6.82|<0.0001
73864186|NCT02905006|147274847|SUPERIORITY||Odds Ratio (OR)|94.51|||<|0.0001|TWO_SIDED|95.0|18.54|481.86|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||481.86|18.54|<0.0001
73864187|NCT02905006|147274847|SUPERIORITY||Odds Ratio (OR)|117.66|||<|0.0001|TWO_SIDED|95.0|22.08|626.89|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||626.89|22.08|<0.0001
73864188|NCT02905006|147274847|SUPERIORITY||Odds Ratio (OR)|280.76|||<|0.0001|TWO_SIDED|95.0|44.06|1789.24|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||1789.24|44.06|<0.0001
73864189|NCT02905006|147274847|SUPERIORITY||Odds Ratio (OR)|107.83|||<|0.0001|TWO_SIDED|95.0|20.82|558.57|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||558.57|20.82|<0.0001
73864190|NCT02905006|147274848|SUPERIORITY||||||=|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||=0.0001
73864191|NCT02905006|147274848|SUPERIORITY||||||=|0.0002|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||=0.0002
73864192|NCT02905006|147274848|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
73864193|NCT02905006|147274848|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
73864194|NCT02905006|147274848|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
73864195|NCT02429791|147274879|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -10%.|Risk Difference (RD)|-0.6|||||TWO_SIDED|95.0|-4.3|3.0|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INI).|||3.0|-4.3|
73864196|NCT02429791|147274881|OTHER||Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-1.9|4.0|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INI). No formal non-inferiority margin has been pre-specified for secondary endpoints.|||4.0|-1.9|
73864197|NCT02429791|147274892|OTHER|||||||0.007||||||P-value for interaction between treatment group and baseline third agent (25 hydroxy-vitamin D)|ANCOVA|||||||0.007
73864198|NCT02429791|147274892|SUPERIORITY||Odds Ratio (OR)|0.958||||0.275|TWO_SIDED|95.0|0.888|1.034||P value to assess difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||1.034|0.888|0.275
73864199|NCT02429791|147274892|SUPERIORITY||Odds Ratio (OR)|0.902||||0.112|TWO_SIDED|95.0|0.793|1.025||P value to assess difference between treatment groups (25 hydroxy-vitamin D - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||1.025|0.793|0.112
73864200|NCT02429791|147274892|SUPERIORITY||Odds Ratio (OR)|0.847||||0.002|TWO_SIDED|95.0|0.763|0.942||P value to assess difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||0.942|0.763|0.002
73864201|NCT02429791|147274894|OTHER|||||||0.001||||||P-value for interaction between treatment group and baseline third agent (bone-specific alkaline phosphatase)|ANCOVA|||||||0.001
73864202|NCT02429791|147274894|SUPERIORITY||Odds Ratio (OR)|0.724|||<|0.001|TWO_SIDED|95.0|0.679|0.772||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.772|0.679|<.001
73864203|NCT02429791|147274894|SUPERIORITY||Odds Ratio (OR)|0.825|||<|0.001|TWO_SIDED|95.0|0.742|0.918||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.918|0.742|<.001
73864204|NCT02429791|147274894|SUPERIORITY||Odds Ratio (OR)|0.81|||<|0.001|TWO_SIDED|95.0|0.742|0.884||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.884|0.742|<.001
73864205|NCT02429791|147274894|OTHER|||||||0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA|||||||0.677
73864206|NCT02429791|147274894|SUPERIORITY||Odds Ratio (OR)|0.817|||<|0.001|TWO_SIDED|95.0|0.774|0.863||P value to assess difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.863|0.774|<.001
73864207|NCT02429791|147274894|OTHER||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA|||||||<.001
73864208|NCT02429791|147274894|SUPERIORITY||Odds Ratio (OR)|0.881|||<|0.001|TWO_SIDED|95.0|0.823|0.943||P value to assess difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.943|0.823|<.001
73932458|NCT01610700|147394858|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.12|STANDARD_ERROR_OF_MEAN|0.83||0.889|TWO_SIDED|95.0|-1.77|1.54|||ANCOVA|||The change from baseline in the mean total bladder control test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||1.54|-1.77|0.889
73864209|NCT02429791|147274894|SUPERIORITY||Odds Ratio (OR)|0.829||||0.001|TWO_SIDED|95.0|0.74|0.93||P value to assess difference between treatment groups (osteocalcin - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.930|0.740|0.001
73864210|NCT02429791|147274894|SUPERIORITY||Odds Ratio (OR)|0.691|||<|0.001|TWO_SIDED|95.0|0.628|0.759||P value to assess difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.759|0.628|<.001
73864211|NCT02429791|147274894|OTHER|||||||0.782||||||P-value for interaction between treatment group and baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA|||||||0.782
73864212|NCT02429791|147274894|SUPERIORITY||Odds Ratio (OR)|0.804|||<|0.001|TWO_SIDED|95.0|0.742|0.872||P value to assess difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.872|0.742|<.001
73864213|NCT02429791|147274907|OTHER|||||||0.317||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value \<=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected|||||||0.317
73864214|NCT02429791|147274907|OTHER||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.7|1.5|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||1.5|-7.7|
73864215|NCT02429791|147274907|OTHER||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-5.1|9.0|||||INI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||9.0|-5.1|
73864216|NCT02429791|147274907|OTHER||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-5.3|10.8|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||10.8|-5.3|
74008242|NCT03627767|147566488|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|32.8|48.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.1|32.8|< 0.0001
73864217|NCT02429791|147274915|OTHER|||||||0.94||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA|||||||0.940
74008243|NCT03627767|147566488|SUPERIORITY||Difference in percentage|20.9|||||TWO_SIDED|95.0|11.8|30.0||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.0|11.8|
73864218|NCT02429791|147274915|SUPERIORITY||Mean Difference (Final Values)|-2.924|||<|0.001|TWO_SIDED|95.0|-4.26|-1.588||P value to assess difference between treatment groups (Week 4)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-1.588|-4.260|<.001
73864219|NCT02429791|147274915|OTHER|||||||0.001||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA|||||||0.001
73932459|NCT01610700|147394861|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.1||||0.047|TWO_SIDED|95.0|-14.11|-0.08|||ANCOVA|||The from baseline in the mean sleep quality 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||-0.08|-14.11|0.047
73864220|NCT02429791|147274915|SUPERIORITY||Mean Difference (Final Values)|-1.192||||0.11|TWO_SIDED|95.0|-2.656|0.271||P value to assess difference between treatment groups (Week 24)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.271|-2.656|0.110
73864221|NCT02429791|147274915|OTHER|||||||0.048||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA|||||||0.048
73864222|NCT02429791|147274915|SUPERIORITY||Mean Difference (Final Values)|-1.569||||0.038|TWO_SIDED|95.0|-3.048|-0.09||P value to assess difference between treatment groups (Week 48)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-0.090|-3.048|0.038
73864223|NCT02429791|147274918|SUPERIORITY|||||||0.002||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.002
73864224|NCT02429791|147274918|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||<0.001
73864225|NCT02429791|147274918|SUPERIORITY|||||||0.024||||||P-value to assess HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.024
73864226|NCT02429791|147274918|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||<0.001
73932460|NCT01610700|147394862|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-4.53||||0.198|TWO_SIDED|95.0|-11.45|2.4|||ANCOVA|||The change from baseline in the mean sleep amount 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.40|-11.45|0.198
73932461|NCT01610700|147394863|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.36||||0.717|TWO_SIDED|95.0|-8.8|6.07|||ANCOVA|||The from baseline in the mean feeling upon wakening 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||6.07|-8.80|0.717
73932462|NCT01610700|147394864|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.47||||0.087|TWO_SIDED|95.0|-1.01|0.07|||ANCOVA|||The change from baseline in the mean Barthel Activities for Daily Living scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.07|-1.01|0.087
73864227|NCT02429791|147274918|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||<0.001
73864228|NCT02429791|147274918|SUPERIORITY|||||||0.005||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.005
73864229|NCT02429791|147274918|SUPERIORITY|||||||0.063||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.063
73864230|NCT02429791|147274918|SUPERIORITY|||||||0.002||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.002
73864231|NCT02429791|147274918|SUPERIORITY|||||||0.099||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.099
73864232|NCT04201093|147274933|SUPERIORITY||LS Mean of Difference|-11.5|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-13.8|-9.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-9.2|-13.8|<0.0001
73864233|NCT04201093|147274933|SUPERIORITY||LS Mean of Difference|-12.1|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-14.4|-9.8||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-9.8|-14.4|<0.0001
73864234|NCT04201093|147274934|SUPERIORITY||LS Mean of Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.3|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-1.7|-3.3|<0.0001
73864235|NCT04201093|147274934|SUPERIORITY||LS Mean of Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.4|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-1.7|-3.4|<0.0001
73864236|NCT04201093|147274935|SUPERIORITY||Odds Ratio (OR)|6.148|||<|0.0001|TWO_SIDED|95.0|3.339|11.321|||Mixed Models Analysis|||||11.321|3.339|<0.0001
74030226|NCT03415464|147614567|OTHER|||||||0.134|||||||Chi-squared|||||||0.134
73864237|NCT04201093|147274935|SUPERIORITY||Odds Ratio (OR)|5.968|||<|0.0001|TWO_SIDED|95.0|3.22|11.062|||Mixed Models Analysis|||||11.062|3.220|<0.0001
73864238|NCT04201093|147274936|SUPERIORITY||LS Mean of Difference|-11.5|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-13.8|-9.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.2|-13.8|<0.0001
73864239|NCT04201093|147274936|SUPERIORITY||LS Mean of Difference|-12.1|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-14.4|-9.8||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.8|-14.4|<0.0001
73864240|NCT04201093|147274937|SUPERIORITY||LS Mean of Difference|-11.7|STANDARD_ERROR_OF_MEAN|1.35|<|0.0001|TWO_SIDED|95.0|-14.4|-9.1||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.1|-14.4|<0.0001
73864241|NCT04201093|147274937|SUPERIORITY||LS Mean of Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.37|<|0.0001|TWO_SIDED|95.0|-14.7|-9.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.3|-14.7|<0.0001
73864242|NCT04201093|147274938|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.38||0.4822|TWO_SIDED|95.0|-1.0|0.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part I: Week 26||0.5|-1.0|0.4822
73864243|NCT04201093|147274938|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.38||0.7742|TWO_SIDED|95.0|-0.9|0.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part I: Week 26||0.6|-0.9|0.7742
73864244|NCT04201093|147274938|SUPERIORITY||LS Mean of Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.3|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part II: Week 26||-1.7|-3.3|<0.0001
74088728|NCT03465436|147730588|SUPERIORITY||LS Mean|0.5|||||TWO_SIDED|90.0|0.16|0.84|||Mixed Models Analysis|||4 hours postdose||0.84|0.16|
73864245|NCT04201093|147274938|SUPERIORITY||LS Mean of Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.4|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part II: Week 26||-1.7|-3.4|<0.0001
73932463|NCT01610700|147394868|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.81||||0.048|TWO_SIDED|95.0|0.02|3.6|||ANCOVA|||The change from baseline in the mean Guy's Neurological Disability Scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||3.60|0.02|0.048
74088729|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.1|||||TWO_SIDED|90.0|-0.56|0.36|||Mixed Models Analysis|||6 hours postdose||0.36|-0.56|
74088730|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.11|||||TWO_SIDED|90.0|-0.56|0.33|||Mixed Models Analysis|||8 hours postdose||0.33|-0.56|
73864246|NCT04201093|147274938|SUPERIORITY||LS Mean of Difference|-9.0|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-10.8|-7.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part III: Week 26||-7.3|-10.8|<0.0001
73864247|NCT04201093|147274938|SUPERIORITY||LS Mean of Difference|-9.4|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|-11.2|-7.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part III: Week 26||-7.6|-11.2|<0.0001
73864248|NCT04201093|147274939|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.3|-0.6|<0.0001
73864249|NCT04201093|147274939|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.5|-0.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.2|-0.5|<0.0001
73864250|NCT04201093|147274940|SUPERIORITY||LS Mean of Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.4|<0.0001
73971642|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-5.902||||0.0972|TWO_SIDED|95.0|-12.881|1.077|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.077|-12.881|0.0972
74030227|NCT02986958|147614571|OTHER|We used generalized estimating equations with an exchangeable correlation structure to assess the direction, magnitude, and statistical significance of between-group differences. Regression models included treatment assignment and patient-level covariates (patient age, gender, and MMSE score) that were postulated as affecting communication outcomes. Statistical tests were 2-sided with a significance level of 0.05. Analyses were performed in SAS statistical software, version 9.4 (SAS, Cary, NC).|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.046|TWO_SIDED||||||t-test, 2 sided|||||||0.046
73864251|NCT04201093|147274940|SUPERIORITY||LS Mean of Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.7|-1.2|<0.0001
73864252|NCT04201093|147274941|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.4|<0.0001
73864253|NCT04201093|147274941|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.5|<0.0001
73864254|NCT04201093|147274942|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32||0.6047|TWO_SIDED|95.0|-0.8|0.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.5|-0.8|0.6047
73864255|NCT04201093|147274942|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.33||0.257|TWO_SIDED|95.0|-1.0|0.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.3|-1.0|0.2570
73864256|NCT04201093|147274943|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.8516|TWO_SIDED|95.0|-1.4|1.1||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.1|-1.4|0.8516
73864257|NCT04201093|147274943|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.64||0.6421|TWO_SIDED|95.0|-1.6|1.0||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.0|-1.6|0.6421
74030228|NCT02260193|147614583|SUPERIORITY||Least Squares Mean Differences|0.29|||||TWO_SIDED|95.0|-0.25|0.82||||||||0.82|-0.25|
74030229|NCT02260193|147614583|SUPERIORITY||Least Squares Mean Differences|0.36|||||TWO_SIDED|95.0|-0.19|0.9||||||||0.90|-0.19|
74030230|NCT02260193|147614583|SUPERIORITY||Least Squares Mean Differences|0.07|||||TWO_SIDED|95.0|-0.48|0.61||||||||0.61|-0.48|
74030231|NCT02260193|147614584|SUPERIORITY||Least Squares Mean Differences|0.04|||||TWO_SIDED|95.0|-0.54|0.61||||||||0.61|-0.54|
73864258|NCT02227394|147275038|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.187||||0.727|TWO_SIDED|90.0|-1.098|0.724|||t-test, 2 sided|||||0.724|-1.098|0.727
73864259|NCT02227394|147275039|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.003||||0.366|TWO_SIDED|90.0|-0.002|0.007|||t-test, 2 sided|||||0.007|-0.002|0.366
73864260|NCT02227394|147275041|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.025||||0.486|TWO_SIDED|90.0|-0.035|0.084|||t-test, 2 sided|||||0.084|-0.035|0.486
73864261|NCT02227394|147275042|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.049||||0.413|TWO_SIDED|90.0|-0.052|0.15|||t-test, 2 sided|||||0.150|-0.052|0.413
73864262|NCT02227394|147275043|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.1||||0.375|TWO_SIDED|90.0|-0.289|0.09|||t-test, 2 sided|||||0.090|-0.289|0.375
73864263|NCT02227394|147275044|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.009||||0.879|TWO_SIDED|90.0|-0.092|0.11|||t-test, 2 sided|||||0.110|-0.092|0.879
73864264|NCT02227394|147275045|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.023||||0.819|TWO_SIDED|90.0|-0.149|0.195|||t-test, 2 sided|||||0.195|-0.149|0.819
73864265|NCT02227394|147275046|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.4||||0.643|TWO_SIDED|90.0|-1.87|1.07|||t-test, 2 sided|||||1.070|-1.870|0.643
73864266|NCT02227394|147275047|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.011||||0.866|TWO_SIDED|90.0|-0.1|0.122|||t-test, 2 sided|||||0.122|-0.100|0.866
73864267|NCT02227394|147275048|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.054||||0.346|TWO_SIDED|90.0|-0.043|0.152|||t-test, 2 sided|||||0.152|-0.043|0.346
74030232|NCT02260193|147614584|SUPERIORITY||Least Squares Mean Differences|0.1|||||TWO_SIDED|95.0|-0.49|0.7||||||||0.70|-0.49|
74030233|NCT02260193|147614584|SUPERIORITY||Least squares mean difference|0.07|||||TWO_SIDED|95.0|-0.53|0.66||||||||0.66|-0.53|
73932464|NCT01610700|147394869|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.904|TWO_SIDED|95.0|-1.85|1.64|||ANCOVA|||The change from baseline in the mean Atkinson Morley Information Processing Battery test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||1.64|-1.85|0.904
73932465|NCT00127790|147394894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.01|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.010
74030234|NCT02260193|147614585|SUPERIORITY||Least squares mean difference|-0.34|||||TWO_SIDED|95.0|-0.71|0.04||||||||0.04|-0.71|
74030235|NCT02260193|147614585|SUPERIORITY||Least squares mean difference|-0.11|||||TWO_SIDED|95.0|-0.5|0.29||||||||0.29|-0.50|
74030236|NCT02260193|147614585|SUPERIORITY||Least squares mean difference|0.23|||||TWO_SIDED|95.0|-0.16|0.62||||||||0.62|-0.16|
74030237|NCT04430582|147614622|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
74030238|NCT04430582|147614623|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
74030239|NCT04430582|147614624|OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
74030240|NCT04430582|147614625|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
74030241|NCT04430582|147614626|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
74030242|NCT04430582|147614627|OTHER|||||||0.95|||||||Kruskal-Wallis|||||||0.95
74030243|NCT04430582|147614628|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
73932466|NCT00127790|147394894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.581|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.581
74030244|NCT04430582|147614629|OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
74030245|NCT04430582|147614630|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
74030246|NCT04430582|147614631|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
74030247|NCT04430582|147614632|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
74030248|NCT04430582|147614633|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
74030249|NCT04430582|147614634|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
74030250|NCT04430582|147614635|OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
74030251|NCT04430582|147614636|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
74030252|NCT01850563|147614694|OTHER||Hazard Ratio (HR)|0.87||||0.76|TWO_SIDED||||||Kaplan-Meier|||||||0.76
74030253|NCT01850563|147614696|OTHER||Hazard Ratio (HR)|0.82||||0.76|TWO_SIDED||||||Kaplan-Meier|||||||0.76
74088731|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.84|0.06|||Mixed Models Analysis|||12 hours postdose||0.06|-0.84|
73864268|NCT02227394|147275049|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.029||||0.093|TWO_SIDED|90.0|0.001|0.058|||t-test, 2 sided|||||0.058|0.001|0.093
73864269|NCT02227394|147275050|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.074||||0.686|TWO_SIDED|90.0|-0.386|0.238|||t-test, 2 sided|||||0.238|-0.386|0.686
73932467|NCT00127790|147394894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6||||0.011|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.011
73932468|NCT00127790|147394895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.33|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.33
73932469|NCT00127790|147394895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.112|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.112
73932470|NCT00127790|147394895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.737|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.737
73932471|NCT00127790|147394896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.063|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.063
73932472|NCT00127790|147394896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.786|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.786
73864270|NCT02227394|147275052|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-10.368||||0.312|TWO_SIDED|90.0|-27.659|6.922|||t-test, 2 sided|||||6.922|-27.659|0.312
73932473|NCT00127790|147394896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.039|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.039
73932474|NCT00127790|147394897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.2||||0.016|||||||Generlaized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.016
73932475|NCT00127790|147394897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4||||0.187|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.187
74030254|NCT01505491|147614719|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|113.22|STANDARD_ERROR_OF_MEAN|1.086||0.1163|TWO_SIDED|90.0|98.752|129.812|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||129.812|98.752|0.1163
74088732|NCT03465436|147730588|SUPERIORITY||LS Mean|0.04|||||TWO_SIDED|90.0|-0.37|0.45|||Mixed Models Analysis|||24 hours postdose||0.45|-0.37|
74088733|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.09|||||TWO_SIDED|90.0|-0.45|0.28|||Mixed Models Analysis|||30 minutes postdose||0.28|-0.45|
74088734|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.1|||||TWO_SIDED|90.0|-0.46|0.27|||Mixed Models Analysis|||1 hour postdose||0.27|-0.46|
73932476|NCT00127790|147394897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2||||0.015|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.015
73932477|NCT01174030|147394925|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.392|||<|0.001||95.0|2.637|26.71|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||26.710|2.637|<0.001
73932478|NCT01174030|147394925|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.269||||0.549||95.0|0.586|2.747|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||2.747|0.586|0.549
73932479|NCT01174030|147394925|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.738||||0.027||95.0|1.097|12.742|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||12.742|1.097|0.027
73932480|NCT01174030|147394926|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.683||||0.003||95.0|1.388|5.188|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model||||5.188|1.388|.003
73932481|NCT01174030|147394926|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.892||||0.056||95.0|0.98|3.651|||GEE: Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.651|0.980|0.056
73932482|NCT01174030|147394926|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.885||||0.074||95.0|0.946|3.756|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.756|0.946|0.074
73932483|NCT01174030|147394927|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.582|||<|0.001||95.0|2.755|15.723|||GEE: Logit link function|Generalize Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||15.723|2.755|<0.001
73932484|NCT01174030|147394927|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.853||||0.093||95.0|0.903|3.802|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.802|0.903|0.093
73932485|NCT01174030|147394927|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.365||||0.054||95.0|0.96|5.825|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||5.825|0.960|0.054
73932486|NCT02809976|147394939|OTHER|single group/descriptive analysis||||||0.02|||||||paired t-test|||||||0.02
73957795|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.613|STANDARD_ERROR_OF_MEAN|0.409||0.1342|TWO_SIDED|95.0|-1.416|0.19|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.190|-1.416|0.1342
73957796|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.367|STANDARD_ERROR_OF_MEAN|0.424||0.3868|TWO_SIDED|95.0|-1.199|0.465|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.465|-1.199|0.3868
73864271|NCT02227394|147275053|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.02||||0.92|TWO_SIDED|90.0|-0.361|0.321|||t-test, 2 sided|||||0.321|-0.361|0.920
73864272|NCT02227394|147275054|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.08||||0.818|TWO_SIDED|90.0|-0.513|0.673|||t-test, 2 sided|||||0.673|-0.513|0.818
73864273|NCT02227394|147275055|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|11.4||||0.034|TWO_SIDED|90.0|2.789|20.011|||t-test, 2 sided|||||20.011|2.789|0.034
73864274|NCT02227394|147275056|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|5.6||||0.427|TWO_SIDED|90.0|-6.323|17.523|||t-test, 2 sided|||||17.523|-6.323|0.427
73864275|NCT03445559|147275059|SUPERIORITY||Odds Ratio (OR)|0.54||||0.006|TWO_SIDED|95.0|0.3|0.98|||Chi-squared|||||0.98|0.30|0.006
73864276|NCT03445559|147275060|SUPERIORITY||Odds Ratio (OR)|1.36||||0.42|TWO_SIDED|95.0|0.7|2.66|||Chi-squared|||||2.66|0.70|0.42
73864277|NCT03445559|147275061|SUPERIORITY||Median Difference (Final Values)|2.7|||||TWO_SIDED|||||||||||||
73864279|NCT04676867|147275085|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
73864280|NCT04676867|147275086|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
73864281|NCT04676867|147275087|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
73864282|NCT04676867|147275088|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
73932487|NCT00113516|147394946|SUPERIORITY_OR_OTHER||probability|0.405|||||TWO_SIDED|90.0|0.315|0.494|||Kaplan-Meier||The probability of survival along with the corresponding confidence interval (CI) (for the log \[-log (1-year survival rate)\]) was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival rate itself.|The study was designed to test the null hypothesis that the true one-year probability of survival is 0.40 versus the alternative hypothesis that the true one-year probability of survival is at least 0.55. The sample size was determined using a One-Sample Survival design, assuming alpha=0.05 (1-sided), power= 0.90, 6 month accrual, a minimum follow-up period of 12 months, and an expectation that approximately 5% of subjects may be lost to follow-up.||0.494|0.315|
73932488|NCT00113516|147394950|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|27.4|||||TWO_SIDED|95.0|18.2|38.2||||||||38.2|18.2|
73932489|NCT00113516|147394964|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Wilcoxon Rank Sum Test|||||||0.474
73932490|NCT00113516|147394965|SUPERIORITY_OR_OTHER|||||||0.836||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.836
73932491|NCT00113516|147394965|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.071
73932492|NCT00113516|147394965|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.393
73932493|NCT00113516|147394965|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.029
73932494|NCT00113516|147394965|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.247
73932495|NCT00113516|147394966|SUPERIORITY_OR_OTHER|||||||0.305||95.0|||||Wilcoxon Rank Sum Test|||||||0.305
73932496|NCT00113516|147394967|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.738
74088735|NCT03465436|147730588|SUPERIORITY||LS Mean|0.25|||||TWO_SIDED|90.0|-0.1|0.6|||Mixed Models Analysis|||1.5 hours postdose||0.60|-0.10|
73864283|NCT04676867|147275089|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
73864284|NCT04676867|147275090|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
73864285|NCT04676867|147275091|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
73864286|NCT04676867|147275092|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
73864287|NCT04676867|147275093|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
73864288|NCT04676867|147275094|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
73864289|NCT04676867|147275095|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
73864290|NCT04676867|147275097|SUPERIORITY|||||||0.2|||||||ANOVA|||||||0.2
73864291|NCT04676867|147275098|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
73864292|NCT00548717|147275127|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 1.||||0.77
73864293|NCT00548717|147275127|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 2.||||0.59
73864294|NCT00548717|147275127|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 3.||||0.92
73864295|NCT00548717|147275127|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 8.||||0.63
73932497|NCT00113516|147394967|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.438
73932498|NCT00113516|147394967|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.236
74088736|NCT03465436|147730588|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|90.0|-0.38|0.4|||Mixed Models Analysis|||2 hours postdose||0.40|-0.38|
73864296|NCT00548717|147275127|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 12.||||0.79
73864297|NCT02809053|147275132|OTHER|The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).|Adjusted Difference Rate (%)|-4.2|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-14.8|6.35|||||Comparison: SAIT101 versus MabThera.|Adjusted Difference Rate (%) in Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 28.||6.35|-14.80|
73864298|NCT02809053|147275133|OTHER|The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).|Adjusted Difference Rate|-10.3|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-20.92|0.61|||||Comparison: SAIT101 versus MabThera|Adjusted Difference Rate of Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 12.||0.61|-20.92|
73932499|NCT00113516|147394967|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.287
73932500|NCT00113516|147394967|SUPERIORITY_OR_OTHER|||||||0.772||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.772
73932501|NCT00113516|147394968|SUPERIORITY_OR_OTHER|||||||0.537||95.0|||||Wilcoxon Rank Sum Test|||||||0.537
73932502|NCT00113516|147394969|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.813
73932503|NCT00113516|147394969|SUPERIORITY_OR_OTHER|||||||0.849||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.849
73864299|NCT02809053|147275138|OTHER|The estimated Hazard Ratio with 95% CI was obtained from Cox regression model; however, stratification factors, ie, FLIPI-2 (low, intermediate and high risk), were only taken into account if FLIPI-2 score=all.|Hazard Ratio (HR)|1.724|||||TWO_SIDED|95.0|0.853|3.482|||||Hazard Ration of TTE SAIT101:MabThera|Time to Event (TTE) Hazard Ratio (HR) of SAIT101:MabThera. The TTE is defined as the time from the date of randomization to the date when an event occurs; an event is disease progression as assessed by Investigator, death due to any cause, or the start of new treatment, whichever comes first.||3.482|0.853|
73932504|NCT00113516|147394969|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.121
73864300|NCT02809053|147275139|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Difference (%)|101.39|||||TWO_SIDED|90.0|95.86|107.24|||||Comparison: SAIT101 versus MabThera. Equivalence was demonstrated for SAIT101 and MabThera with exposure pharmacokinetic parameter AUC0-168,w1 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) (%) of SAIT101 versus MabThera Area Under the Concentration time Curve Day 0 to Week 1 (AUC0-168,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||107.24|95.86|
73932505|NCT00113516|147394969|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.582
73932506|NCT00113516|147394969|SUPERIORITY_OR_OTHER|||||||0.383||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.383
73932507|NCT00113516|147394970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.6782|TWO_SIDED|95.0|0.61|2.15|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.15|0.61|0.6782
73932508|NCT00113516|147394970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.198|TWO_SIDED|95.0|0.77|3.3|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.30|0.77|0.1980
73932509|NCT00113516|147394970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.1344|TWO_SIDED|95.0|0.82|3.98|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.98|0.82|0.1344
73932510|NCT00113516|147394970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.4809|TWO_SIDED|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||3.39|0.56|0.4809
73932511|NCT00113516|147394970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.6||||0.0153|TWO_SIDED|95.0|1.19|11.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 3, Day 1||11.13|1.19|0.0153
73932512|NCT00113516|147394970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.7||||0.2085|TWO_SIDED|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 3, Day 28||14.37|0.52|0.2085
74030255|NCT01505491|147614719|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|132.24|STANDARD_ERROR_OF_MEAN|1.094||0.7345|TWO_SIDED|90.0|113.984|153.412|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||153.412|113.984|0.7345
74088737|NCT03465436|147730588|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|90.0|-0.34|0.37|||Mixed Models Analysis|||2.5 hours postdose||0.37|-0.34|
73932513|NCT00113516|147394970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 5, Day 28||23.57|0.08|0.8084
73932514|NCT00113516|147394971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.507|TWO_SIDED|95.0|0.65|2.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.39|0.65|0.5070
73932515|NCT00113516|147394971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.4474|TWO_SIDED|95.0|0.63|2.82|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||2.82|0.63|0.4474
73932516|NCT00113516|147394971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7599|TWO_SIDED|95.0|0.4|1.95|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||1.95|0.40|0.7599
73932517|NCT00113516|147394971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0109|TWO_SIDED|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||0.80|0.12|0.0109
73932518|NCT00113516|147394971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.6878|TWO_SIDED|95.0|0.43|3.58|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||3.58|0.43|0.6878
73864301|NCT02809053|147275139|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Difference (%)|96.92|||||TWO_SIDED|90.0|90.85|103.4|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter AUC0-168,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) %) of SAIT101 versus MabThera Area Under the Concentration time Cure Day 0 to Week 4 (AUC0-168,w4) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||103.40|90.85|
73932519|NCT00113516|147394971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.7||||0.4637|TWO_SIDED|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||8.12|0.38|0.4637
73932520|NCT00113516|147394972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5277|TWO_SIDED|95.0|0.39|1.62|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.62|0.39|0.5277
73932521|NCT00113516|147394972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.466|TWO_SIDED|95.0|0.58|3.29|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 1, Day 28||3.29|0.58|0.4660
74008244|NCT03627767|147566491|SUPERIORITY||LSM difference|0.0|||=|0.9207|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Pruritus VAS: Week 12: The least squares mean (LSM) differences between treatment groups were derived from the statistical model. Mixed model repeated measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|= 0.9207
73932522|NCT00113516|147394972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.5337|TWO_SIDED|95.0|0.52|3.44|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 2, Day 1||3.44|0.52|0.5337
73932523|NCT00113516|147394972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0712|TWO_SIDED|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 2, Day 28||1.13|0.13|0.0712
73932524|NCT00113516|147394972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.2948|TWO_SIDED|95.0|0.54|7.07|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 3, Day 1||7.07|0.54|0.2948
73932525|NCT00113516|147394972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.3||||0.32|TWO_SIDED|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 3, Day 28||38.48|0.28|0.3200
73932526|NCT00113516|147394973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.7824|TWO_SIDED|95.0|0.56|2.17|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.17|0.56|0.7824
73932527|NCT00113516|147394973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.1918|TWO_SIDED|95.0|0.77|3.47|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.47|0.77|0.1918
73932528|NCT00113516|147394973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.1093|TWO_SIDED|95.0|0.85|4.3|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||4.30|0.85|0.1093
74008245|NCT03627767|147566491|SUPERIORITY||LSM difference|0.0|||=|0.9998|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|= 0.9998
73932529|NCT00113516|147394973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.4809|TWO_SIDED|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||3.39|0.56|0.4809
73932530|NCT00113516|147394973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.2||||0.011|TWO_SIDED|95.0|1.26|13.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||13.85|1.26|0.0110
73932531|NCT00113516|147394973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.7||||0.2085|TWO_SIDED|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||14.37|0.52|0.2085
73932532|NCT00113516|147394973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||23.57|0.08|0.8084
73932533|NCT00113516|147394974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.5215|TWO_SIDED|95.0|0.62|2.53|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.53|0.62|0.5215
73932534|NCT00113516|147394974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.2504|TWO_SIDED|95.0|0.72|3.49|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.49|0.72|0.2504
73932535|NCT00113516|147394974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.8766|TWO_SIDED|95.0|0.42|2.11|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||2.11|0.42|0.8766
73932536|NCT00113516|147394974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0109|TWO_SIDED|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||0.80|0.12|0.0109
73932537|NCT00113516|147394974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.5627|TWO_SIDED|95.0|0.46|4.18|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||4.18|0.46|0.5627
73932538|NCT00113516|147394974|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.7||||0.4637|TWO_SIDED|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||8.12|0.38|0.4637
73932539|NCT00113516|147394975|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.6682|TWO_SIDED|95.0|0.39|1.84|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.84|0.39|0.6682
73932540|NCT00113516|147394975|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.6854|TWO_SIDED|95.0|0.49|3.0|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.00|0.49|0.6854
73932541|NCT00113516|147394975|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.6028|TWO_SIDED|95.0|0.49|3.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.37|0.49|0.6028
73932542|NCT00113516|147394975|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0712|TWO_SIDED|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.13|0.13|0.0712
73932543|NCT00113516|147394975|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.3411|TWO_SIDED|95.0|0.5|7.15|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||7.15|0.50|0.3411
73932544|NCT00113516|147394975|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.3||||0.32|TWO_SIDED|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||38.48|0.28|0.3200
73932545|NCT00113516|147394976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.4768|TWO_SIDED|95.0|0.7|2.17|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.17|0.70|0.4768
73932546|NCT00113516|147394976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.1484|TWO_SIDED|95.0|0.84|3.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.13|0.84|0.1484
73932547|NCT00113516|147394976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.8957|TWO_SIDED|95.0|0.5|2.18|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||2.18|0.50|0.8957
74008246|NCT03627767|147566491|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|
73932548|NCT00113516|147394976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5681|TWO_SIDED|95.0|0.33|1.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.85|0.33|0.5681
73932549|NCT00113516|147394976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.8||||0.0074|TWO_SIDED|95.0|1.35|10.88|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||10.88|1.35|0.0074
73932550|NCT00113516|147394976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.1637|TWO_SIDED|95.0|0.06|1.7|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||1.70|0.06|0.1637
73932551|NCT00113516|147394976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6||||0.4328|TWO_SIDED|95.0|0.23|29.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||29.12|0.23|0.4328
74008247|NCT03627767|147566491|SUPERIORITY||LSM difference|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.7|||Mixed Models Analysis|||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-2.5|< 0.0001
74030256|NCT01505491|147614719|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.51|STANDARD_ERROR_OF_MEAN|1.09||0.1833|TWO_SIDED|90.0|74.974|99.83|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||99.830|74.974|0.1833
73932552|NCT00113516|147394977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.4269|TWO_SIDED|95.0|0.72|2.21|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.21|0.72|0.4269
74088738|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.09|||||TWO_SIDED|90.0|-0.44|0.25|||Mixed Models Analysis|||3 hours postdose||0.25|-0.44|
74088739|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.76|-0.03|||Mixed Models Analysis|||3.5 hours postdose||-0.03|-0.76|
73932553|NCT00113516|147394977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.929|TWO_SIDED|95.0|0.51|1.86|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||1.86|0.51|0.9290
73932554|NCT00113516|147394977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.8195|TWO_SIDED|95.0|0.44|1.91|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||1.91|0.44|0.8195
73932555|NCT00113516|147394977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.221|TWO_SIDED|95.0|0.26|1.38|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.38|0.26|0.2210
73932556|NCT00113516|147394977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.4297|TWO_SIDED|95.0|0.24|1.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||1.85|0.24|0.4297
73932557|NCT00113516|147394977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0522|TWO_SIDED|95.0|0.06|1.11|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||1.11|0.06|0.0522
73932558|NCT00113516|147394977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.6949|TWO_SIDED|95.0|0.05|7.0|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||7.00|0.05|0.6949
73932559|NCT00113516|147394978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.766|TWO_SIDED|95.0|0.51|1.65|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.65|0.51|0.7660
73932560|NCT00113516|147394978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.2682|TWO_SIDED|95.0|0.72|3.23|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.23|0.72|0.2682
73932561|NCT00113516|147394978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.2726|TWO_SIDED|95.0|0.69|3.7|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.70|0.69|0.2726
73932562|NCT00113516|147394978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.2787|TWO_SIDED|95.0|0.22|1.55|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.55|0.22|0.2787
74088740|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.38|||||TWO_SIDED|90.0|-0.73|-0.03|||Mixed Models Analysis|||4 hours postdose||-0.03|-0.73|
73864302|NCT02809053|147275140|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00|GLS Mean Ratio (%)|99.35|||||TWO_SIDED|90.0|90.85|103.4|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with Cmax,w1 exposure within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 1 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||103.40|90.85|
73864303|NCT02809053|147275140|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Ration (%)|99.23|||||TWO_SIDED|90.0|92.96|105.92|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Cmax,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 4 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment||105.92|92.96|
73864304|NCT02809053|147275143|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Ratio (%)|95.45|||||TWO_SIDED|90.0|88.85|102.55|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Ctrough,d29 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera trough plasma concentration at the end of the dosing period (Day 29) (Ctrough,d29) (µg/mL) . The statistical comparison of the log-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment||102.55|88.85|
73864305|NCT02809053|147275147|OTHER||Mean Difference (Final Values)|7.2|||||TWO_SIDED|90.0|-31.0|45.4|||||Comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 1 (AUEC0-168,w1), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||45.4|-31.0|
73864306|NCT02809053|147275147|OTHER||Mean Difference (Final Values)|18.0|||||TWO_SIDED|90.0|-21.6|57.6|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 2 (AUEC0-168,w2), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||57.6|-21.6|
73864307|NCT02809053|147275147|OTHER||Mean Difference (Final Values)|21.4|||||TWO_SIDED|90.0|-18.3|61.0|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 3 (AUEC0-168,w3), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||61.0|-18.3|
73864308|NCT02809053|147275147|OTHER||Mean Difference (Final Values)|20.4|||||TWO_SIDED|90.0|-19.3|60.2|||||comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 4 (AUEC0-168,w4), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||60.2|-19.3|
73864309|NCT02809053|147275147|OTHER||Mean Difference (Final Values)|15.7|||||TWO_SIDED|90.0|-23.1|54.6|||||Comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 12 (AUEC0-168,w12), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||54.6|-23.1|
73864310|NCT02809053|147275147|OTHER||Mean Difference (Final Values)|12.8|||||TWO_SIDED|90.0|-26.0|51.8|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 28 (AUEC0-168,w28), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||51.8|-26.0|
73932563|NCT00113516|147394978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.4||||0.0241|TWO_SIDED|95.0|1.09|17.56|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||17.56|1.09|0.0241
73864311|NCT02809053|147275151|OTHER|||||||0.587||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis: Comparison of Overall Response Rate (ORR) by Region (European Union / Other). The interaction p-value for the Region subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.587
73864312|NCT02809053|147275151|OTHER|||||||0.421||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis. Overall Response Rate by Age Group (18-60 years and \>60 years). The interaction p-value for the Age subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.421
73932564|NCT00113516|147394978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.4||||0.0943|TWO_SIDED|95.0|0.59|48.81|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||48.81|0.59|0.0943
73932565|NCT00113516|147394978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.8084|TWO_SIDED|95.0|0.04|11.79|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||11.79|0.04|0.8084
73932566|NCT00812812|147394989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.198|TWO_SIDED|95.0|-11.7|2.5|||ANCOVA||Mean difference was estimated as paroxetine minus placebo.|||2.5|-11.7|0.198
73932567|NCT03091751|147394994|OTHER||Mean Difference (Final Values)|10.41||||0.77|TWO_SIDED|95.0|-224.88|245.7|||t-test, 1 sided|||||245.70|-224.88|0.77
73864313|NCT02809053|147275151|OTHER|||||||0.288||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Gender (Male / Female). The interaction p-value for the Gender subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate. The p-value was calculated using Gail-Simon Test for Qualitative Interactions.||||0.288
73864314|NCT02809053|147275151|OTHER|||||||0.588||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Wilson|||Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Anti-drug Antibody (ADA) status (Positive / Negative). The interaction p-value for the ADA subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.588
73864315|NCT00869401|147275159|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.222|TWO_SIDED|95.0|0.54|1.16||Using Logrank Test|Log Rank|||||1.16|0.54|.222
73864316|NCT00869401|147275161|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.806||||0.183|TWO_SIDED|95.0|0.59|1.11|||Log Rank|||||1.11|0.59|0.183
73864317|NCT00082381|147275189|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and insulin glargine is less than 0.4%.)|Mean Difference (Final Values)|0.05||||0.4602||95.0|-0.09|0.2|||ANCOVA|||||0.20|-0.09|0.4602
73864318|NCT00082381|147275190|SUPERIORITY_OR_OTHER|||||||0.7839||95.0|||||Fisher Exact|||||||0.7839
73864319|NCT00082381|147275191|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
73864320|NCT00082381|147275192|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
73932568|NCT03091751|147394995|OTHER||Mean Difference (Final Values)|0.3068||||0.002|TWO_SIDED|95.0|0.1501|0.4635|||t-test, 1 sided|||||0.4635|0.1501|0.002
73864321|NCT00082381|147275194|SUPERIORITY_OR_OTHER|||||||0.3002||95.0|||||Fisher Exact|||||||0.3002
73864322|NCT00082381|147275195|SUPERIORITY_OR_OTHER|||||||0.3385||95.0|||||ANCOVA|||||||0.3385
73864323|NCT03178669|147275225|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1806|TWO_SIDED|80.0|0.75|5.47||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||5.47|0.75|0.1806
73864324|NCT03178669|147275225|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6649|TWO_SIDED|80.0|0.2|2.24||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.24|0.20|0.6649
73864325|NCT03178669|147275225|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0247|TWO_SIDED|80.0|1.53|9.47||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||9.47|1.53|0.0247
73864326|NCT03178669|147275225|SUPERIORITY||Odds Ratio (OR)|1.4||||0.3279|TWO_SIDED|80.0|0.52|3.88||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||3.88|0.52|0.3279
73864327|NCT03178669|147275226|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2115|TWO_SIDED|80.0|0.69|4.99||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||4.99|0.69|0.2115
73864328|NCT03178669|147275226|SUPERIORITY||Odds Ratio (OR)|0.3||||0.8498|TWO_SIDED|80.0|0.06|1.34||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.34|0.06|0.8498
73932569|NCT03091751|147394996|OTHER||Mean Difference (Final Values)|-3.3||||0.3|TWO_SIDED|95.0|-8.9|2.3|||t-test, 1 sided|||||2.3|-8.9|0.30
73864329|NCT03178669|147275226|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0977|TWO_SIDED|80.0|1.01|6.62||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||6.62|1.01|0.0977
73864330|NCT03178669|147275226|SUPERIORITY||Odds Ratio (OR)|1.0||||0.522|TWO_SIDED|80.0|0.32|2.84||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.84|0.32|0.5220
73864331|NCT03178669|147275227|SUPERIORITY||Odds Ratio (OR)|1.5||||0.2335|TWO_SIDED|80.0|0.74|2.94||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.94|0.74|0.2335
73864332|NCT03178669|147275227|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2511|TWO_SIDED|80.0|0.73|2.69||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.69|0.73|0.2511
73864333|NCT03178669|147275227|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1162|TWO_SIDED|80.0|0.96|3.52||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||3.52|0.96|0.1162
73864334|NCT03178669|147275227|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3467|TWO_SIDED|80.0|0.63|2.4||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.40|0.63|0.3467
73864335|NCT03178669|147275228|SUPERIORITY||Odds Ratio (OR)|0.9||||0.6326|TWO_SIDED|80.0|0.5|1.5||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.50|0.50|0.6326
73864336|NCT03178669|147275228|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7127|TWO_SIDED|80.0|0.45|1.37||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.37|0.45|0.7127
73864337|NCT03178669|147275228|SUPERIORITY||Odds Ratio (OR)|1.3||||0.2658|TWO_SIDED|80.0|0.75|2.34||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.34|0.75|0.2658
73864338|NCT03178669|147275228|SUPERIORITY||Odds Ratio (OR)|0.6||||0.8301|TWO_SIDED|80.0|0.36|1.16||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.16|0.36|0.8301
73864339|NCT03178669|147275229|SUPERIORITY||Odds Ratio (OR)|0.6||||0.7994|TWO_SIDED|80.0|0.32|1.27||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.27|0.32|0.7994
73932570|NCT03091751|147394997|OTHER||Mean Difference (Final Values)|-0.0058||||0.16|TWO_SIDED|95.0|-0.0119|0.0003|||t-test, 1 sided|||||0.0003|-0.0119|0.16
73932571|NCT03091751|147394998|OTHER||Mean Difference (Final Values)|-7.609||||0.02|TWO_SIDED|95.0|-13.344|-1.879|||t-test, 1 sided|||||-1.879|-13.344|0.02
73864340|NCT03178669|147275229|SUPERIORITY||Odds Ratio (OR)|0.3||||0.9665|TWO_SIDED|80.0|0.16|0.72||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.72|0.16|0.9665
73864341|NCT03178669|147275229|SUPERIORITY||Odds Ratio (OR)|1.5||||0.2049|TWO_SIDED|80.0|0.8|2.82||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.82|0.80|0.2049
73864342|NCT03178669|147275229|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6504|TWO_SIDED|80.0|0.42|1.6||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.60|0.42|0.6504
73864343|NCT03178669|147275230|SUPERIORITY||Odds Ratio (OR)|0.4||||0.9207|TWO_SIDED|80.0|0.18|0.93||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.93|0.18|0.9207
73864344|NCT03178669|147275230|SUPERIORITY||Odds Ratio (OR)|0.4||||0.9228|TWO_SIDED|80.0|0.19|0.92||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.92|0.19|0.9228
73864345|NCT03178669|147275230|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6636|TWO_SIDED|80.0|0.39|1.61||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.61|0.39|0.6636
73864346|NCT03178669|147275230|SUPERIORITY||Odds Ratio (OR)|0.7||||0.7449|TWO_SIDED|80.0|0.34|1.41||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.41|0.34|0.7449
73864347|NCT01600092|147275231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G1||1.07|0.79|
73864348|NCT01600092|147275231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.15|||||TWO_SIDED|95.0|0.99|1.33|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G2||1.33|0.99|
73864349|NCT01600092|147275231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|3.2|||||TWO_SIDED|95.0|2.75|3.74|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G3||3.74|2.75|
73864350|NCT01600092|147275231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.06|||||TWO_SIDED|95.0|0.94|1.2|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G4||1.20|0.94|
73864351|NCT01600092|147275231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.16|||||TWO_SIDED|95.0|1.0|1.35|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype P1A\[8\]||1.35|1.00|
73932572|NCT01161329|147394999|NON_INFERIORITY_OR_EQUIVALENCE|It was estimated that 128 individuals would be required for 80 % Power with a type I error of 5% to detect a 2-point difference in BBS with a standard deviation of +/- 4 points. Because of the slow recruitment and the statistically significant improvements observed in the primary outcome in the intervention group during an interim analysis the study was finalized with fewer participants than had been initially calculated.||||||0.001||||||The Bonferroni method was used to assess longitudinal Changes and correct for multiple comparisons, with significance set at p\<0.016 to minimize the risk for type I errors.|Wilcoxon (Mann-Whitney)|||Intention-to-treat analysis was performed to assess the effects on the outcome measures. Between-group differences for all outcome measures were analyzed using Mann-Whitney U-test.||||0.001
73864352|NCT00079677|147275236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.0003||95.0|1.67|5.46||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05||5.46|1.67|0.0003
73864353|NCT00079677|147275237|SUPERIORITY_OR_OTHER|||||||0.0069||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|Cochran-Mantel-Haenszel|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||||0.0069
73864354|NCT01300455|147275238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66|||||TWO_SIDED|90.0|0.22|5.09|||Difference of the Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||5.09|0.22|
73864355|NCT01300455|147275241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|90.0|-0.49|0.42|||Difference in the Least Squares Means|||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means||0.42|-0.49|
73864356|NCT01300455|147275241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.45|0.33|||Difference of the Least Squares Means|||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means||0.33|-0.45|
73864357|NCT01300455|147275242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||||TWO_SIDED|90.0|-1.31|2.79|||Difference in the Least Squares Means|||Day 1, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||2.79|-1.31|
73864358|NCT01300455|147275242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|90.0|-0.1|0.59|||Difference in the Least Squares Means|||Day 1, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.59|-0.10|
73864359|NCT01300455|147275242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|90.0|-0.59|1.01|||Difference in the Least Squares Means|||Day 4, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||1.01|-0.59|
73864360|NCT01300455|147275242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.09|0.65|||Difference in the Least Squares Means|||Day 4, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.65|-0.09|
73864361|NCT01300455|147275243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.61|0.49|||Difference of Least Squares Means|||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.49|-0.61|
73864362|NCT01300455|147275243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|90.0|-0.41|0.5|||Difference of the Least Sqares Means|||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.41|
73864363|NCT01300455|147275243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|90.0|-1.13|0.1|||Difference of the Least Squares Means|||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.10|-1.13|
73864364|NCT01300455|147275243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||||TWO_SIDED|90.0|-0.24|0.5|||Difference of the Least Squares Means|||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.24|
73864365|NCT01300455|147275243|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02|||||TWO_SIDED|90.0|-0.4|0.43|||Difference in the Least Squares Means|||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.43|-0.40|
73864366|NCT01300455|147275243|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.18|||||TWO_SIDED|90.0|-0.61|0.25|||Difference in the Least Squares Means|||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.25|-0.61|
73864367|NCT01300455|147275244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|90.0|-3.2|2.26|||Difference of Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||2.26|-3.20|
73864368|NCT02228096|147275361|OTHER||||||<|0.0001|||||||Clopper-Pearson|||||||<0.0001
73864369|NCT03281304|147275467|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|0.5|25.0||||||Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.0|0.5|
73864370|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-7.5|13.4||||||Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.4|-7.5|
73864371|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|0.1|22.8||||||Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.8|0.1|
73864372|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|2.9|25.2||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.2|2.9|
73864373|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|8.0|31.8||||||Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||31.8|8.0|
73864374|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|2.2|28.7||||||Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.7|2.2|
73864375|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|0.0|27.9||||||Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||27.9|0.0|
73864376|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|-0.7|28.5||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.5|-0.7|
73864377|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|7.1|||||TWO_SIDED|95.0|-8.0|21.9||||||Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||21.9|-8.0|
73864378|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|5.7|||||TWO_SIDED|95.0|-9.3|20.4||||||Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||20.4|-9.3|
73932573|NCT01161329|147395000|SUPERIORITY_OR_OTHER|||||||0.09||||||The p-value for the man differnece in SPPB between grpoups att three months was 0.09|Wilcoxon (Mann-Whitney)|||||||0.09
73932574|NCT01298063|147395018|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|92.64|STANDARD_DEVIATION|33.6||0.1998|TWO_SIDED|90.0|67.96|126.27||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||126.270|67.960|0.1998
73864379|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|8.6|||||TWO_SIDED|95.0|-7.0|23.6||||||Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||23.6|-7.0|
73864380|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-12.8|18.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.3|-12.8|
73864381|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.4|17.2||||||Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||17.2|-14.4|
73864382|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
73864383|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|-4.3|||||TWO_SIDED|95.0|-20.2|11.9||||||Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||11.9|-20.2|
73864384|NCT03281304|147275469|OTHER||Adjusted (weighted) difference|4.3|||||TWO_SIDED|95.0|-11.7|19.9||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||19.9|-11.7|
73864385|NCT03281304|147275470|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-1.5|24.1||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||24.1|-1.5|
73864386|NCT03281304|147275470|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|3.6|35.0||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||35.0|3.6|
73864387|NCT03281304|147275470|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.5|28.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.3|-3.5|
73864388|NCT03281304|147275470|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-12.5|18.0||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.0|-12.5|
73864389|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-7.5|13.4||||||Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.4|-7.5|
73864390|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|0.1|22.8||||||Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.8|0.1|
73864391|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|2.4|25.6||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.6|2.4|
73864392|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|8.0|31.8||||||Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||31.8|8.0|
73864393|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|2.2|28.7||||||Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.7|2.2|
73864394|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|0.0|27.9||||||Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||27.9|0.0|
73864395|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|0.7|29.9||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||29.9|0.7|
73864396|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|5.7|||||TWO_SIDED|95.0|-9.5|20.6||||||Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||20.6|-9.5|
73864397|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|7.1|||||TWO_SIDED|95.0|-8.0|21.9||||||Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||21.9|-8.0|
73864398|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|10.0|||||TWO_SIDED|95.0|-5.7|25.1||||||Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.1|-5.7|
73864399|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|4.3|||||TWO_SIDED|95.0|-11.4|19.7||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||19.7|-11.4|
73864400|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.4|17.2||||||Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||17.2|-14.4|
73864401|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
73864402|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|-2.9|||||TWO_SIDED|95.0|-18.8|13.3||||||Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.3|-18.8|
73864403|NCT03281304|147275471|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
73864404|NCT03281304|147275472|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|-0.4|30.8||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||30.8|-0.4|
73864405|NCT03281304|147275472|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.5|28.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.3|-3.5|
73864406|NCT03281304|147275472|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.0|16.7||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||16.7|-14.0|
73932575|NCT01298063|147395018|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|94.88|STANDARD_DEVIATION|31.6||0.144|TWO_SIDED|90.0|72.278|124.549||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||124.549|72.278|0.1440
73864407|NCT03281304|147275473|OTHER||Mean Difference|-0.3|||||TWO_SIDED|95.0|-0.8|0.1||||||||0.1|-0.8|
73864408|NCT03281304|147275475|OTHER||Least Squares (LS) Mean Difference|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Month 1||0.3|-0.1|
73864409|NCT03281304|147275475|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||Month 3||0.2|-0.2|
73864410|NCT03281304|147275475|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.2|0.3||||||Month 6||0.3|-0.2|
73864411|NCT03281304|147275477|OTHER||LS Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.2|0.1||||||||0.1|-1.2|
73864412|NCT03281304|147275479|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Month 1||0.3|-0.3|
73864413|NCT03281304|147275479|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.2||||||Month 3||0.2|-0.3|
73864414|NCT03281304|147275479|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Month 6||0.3|-0.3|
73864415|NCT03281304|147275481|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-0.3|23.1||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||23.1|-0.3|
73864416|NCT03281304|147275481|OTHER||Adjusted (weighted) difference|18.6|||||TWO_SIDED|95.0|3.5|32.6||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||32.6|3.5|
73864417|NCT03281304|147275481|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.3|28.1||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.1|-3.3|
73864418|NCT03281304|147275481|OTHER||Adjusted (weighted) difference|0.0|||||TWO_SIDED|95.0|-16.1|16.1||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||16.1|-16.1|
73864419|NCT03281304|147275482|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|1.3|22.0||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.0|1.3|
73864420|NCT03281304|147275482|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-4.2|26.4||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||26.4|-4.2|
73864421|NCT03281304|147275482|OTHER||Adjusted (weighted) difference|10.0|||||TWO_SIDED|95.0|-5.8|25.2||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.2|-5.8|
73864422|NCT03281304|147275482|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
73864423|NCT02020408|147275509|SUPERIORITY||||||>|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|ANOVA|||||||> 0.05
73864424|NCT02020408|147275510|SUPERIORITY||||||<|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|General Linear Model|||A General Linear Model using log(\[11C\]raclopride BPND) after amphetamine administration as dependent variable and Diagnostic Group as independent variable was used. Baseline (before amphetamine administration) \[11C\]raclopride BPND was used as covariate.||||<0.05
73864425|NCT02720692|147275517|SUPERIORITY||||||<|0.05||||||P\<0.05 applies to Day 1 (0-24 Hours; p=0.0033), Days 1-2 (0-48 Hours; p=0.0077), and Days 1-3 (0-72 Hours; p=0.0152).|ANCOVA|||||||<0.05
73864426|NCT05011513|147275518|SUPERIORITY|||||||0.6027|||||||Log Rank|||||||0.6027
73864427|NCT05011513|147275520|SUPERIORITY|||||||0.1796||||||P-value reported for COVID-19 hospitalization and death due to any cause.|Normal approximation|||||||0.1796
73864428|NCT05011513|147275522|SUPERIORITY|||||||0.0971|||||||Negative binomial|||||||0.0971
73864429|NCT05011513|147275524|SUPERIORITY||Odds Ratio (OR)|0.819||||0.1622|TWO_SIDED|95.0|0.618|1.084|||Regression, Logistic|||Main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.084|0.618|0.1622
73864430|NCT05011513|147275525|SUPERIORITY|||||||0.4298|||||||Log Rank|||||||0.4298
74008248|NCT03627767|147566491|SUPERIORITY||LSM difference|-3.2|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.8|||Mixed Models Analysis|||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.8|-3.6|< 0.0001
74088741|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.6|||||TWO_SIDED|90.0|-1.03|-0.17|||Mixed Models Analysis|||6 hours postdose||-0.17|-1.03|
73864431|NCT05011513|147275528|SUPERIORITY||Odds Ratio (OR)|0.802||||0.1086|TWO_SIDED|95.0|0.613|1.05|||Regression, Logistic|||Main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status (positive/negative), vaccination status (complete/not vaccinated) and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL).||1.050|0.613|0.1086
73864432|NCT05011513|147275529|SUPERIORITY||Odds Ratio (OR)|50.333||||0.3262|TWO_SIDED|95.0|13.163|192.472|||Breslow-Day Test|||||192.472|13.163|0.3262
73864433|NCT05011513|147275529|SUPERIORITY||Odds Ratio (OR)|22.224|||||TWO_SIDED|95.0|8.36|59.08||||||Odds ratio for Day 5 vs Day 1||59.080|8.360|
73864434|NCT03878758|147275533|SUPERIORITY|The average difference in incidence of needle bending with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.39||||0.591|TWO_SIDED|95.0|-1.82|1.04|||Fisher Exact|||||1.04|-1.82|0.591
73864435|NCT03878758|147275533|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.13||||0.931|TWO_SIDED|95.0|-2.8|3.06|||Fisher Exact|||||3.06|-2.8|0.931
73864436|NCT03878758|147275533|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.42||||0.723|TWO_SIDED|95.0|-1.91|2.75|||Fisher Exact|||||2.75|-1.91|0.723
73864437|NCT03878758|147275534|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-5.7|||<|0.001|TWO_SIDED|95.0|-9.0|-3.5|||Fisher Exact|||||-3.5|-9.0|<0.001
73864438|NCT03878758|147275534|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-14.09||||0.026|TWO_SIDED|95.0|-26.49|-1.69||Although a site difference was detected - all sites combined p-value was generated,|Fisher Exact|||||-1.69|-26.49|0.026
73864439|NCT03878758|147275534|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs.Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.2||||0.644|TWO_SIDED|95.0|-1.9|0.6|||Fisher Exact|||||0.6|-1.9|0.644
73864440|NCT03878758|147275535|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.8|||||TWO_SIDED|95.0|0.62|0.98||||||||0.98|0.62|
73864441|NCT03878758|147275535|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|1.0|||||TWO_SIDED|95.0|0.8|1.16||||||||1.16|0.8|
73864442|NCT03878758|147275535|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.3|||||TWO_SIDED|95.0|0.13|0.49||||||||0.49|0.13|
73864443|NCT03878758|147275536|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.192|||<|0.001|ONE_SIDED|95.0||-0.141|||Mixed Models Analysis|||BD Nano Pro vs Artsana 34G||-0.141||<0.001
74008249|NCT03627767|147566491|SUPERIORITY||LSM difference|-1.1|||||TWO_SIDED|95.0|-1.4|-0.7||||||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-1.4|
73864444|NCT03878758|147275536|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.122||||0.104|ONE_SIDED|95.0||0.016|||Mixed Models Analysis|||BD NANO vs Artsana 33G. A significant site effect was detected at one site; the most conservative p-value is reported.||0.016||0.104
73864445|NCT03878758|147275536|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary. The upper bound of the confidence interval was compared to 0.|Mean Difference (Net)|-0.068||||0.003|ONE_SIDED|95.0||-0.017|||Mixed Models Analysis|||BD NANO vs Comfort EZ 33G||-0.017||0.003
73864446|NCT03878758|147275537|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
73864447|NCT03878758|147275537|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
73864448|NCT03878758|147275537|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
73864449|NCT00321464|147275556|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82|||<|0.0001||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.95|0.71|<0.0001
73864450|NCT00321464|147275557|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.01||95.0|0.71|0.95||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.95|0.71|0.010
73864451|NCT00321464|147275558|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.77||||0.001||95.0|0.66|0.89||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Anderson-Gill model||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.89|0.66|0.001
73864452|NCT00652951|147275560|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% confidence interval (CI) of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 1.|GMC ratio|0.89|||||TWO_SIDED|95.0|0.74|1.07|||ANOVA|||The 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 1.||1.07|0.74|
73864453|NCT00652951|147275560|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 4.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.84|1.23|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 4.||1.23|0.84|
73864454|NCT00652951|147275560|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 5.|GMC ratio|0.98|||||TWO_SIDED|95.0|0.83|1.15|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 5.||1.15|0.83|
73864455|NCT00652951|147275560|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 6B.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.69|1.26|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 6B.||1.26|0.69|
73864456|NCT00652951|147275560|NON_INFERIORITY|Non-inferiority criteria: The upper limit of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group Group), was lower than 2 for the pneumococcal vaccine serotype 7F.|GMC ratio|0.96|||||TWO_SIDED|95.0|0.82|1.13|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel Group groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 7F.||1.13|0.82|
73932576|NCT01298063|147395019|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|109.47|STANDARD_DEVIATION|30.3||0.2002|TWO_SIDED|90.0|82.683|144.947||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||144.947|82.683|0.2002
73864457|NCT00652951|147275560|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 9V.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.78|1.16|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 9V.||1.16|0.78|
73864458|NCT00652951|147275560|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 14.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.85|1.21|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 14.||1.21|0.85|
73932577|NCT01298063|147395019|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|126.89|STANDARD_DEVIATION|42.8||0.5281|TWO_SIDED|90.0|86.028|187.159||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||187.159|86.028|0.5281
74030257|NCT01505491|147614720|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|109.42|STANDARD_ERROR_OF_MEAN|1.073||0.0303|TWO_SIDED|90.0|97.384|122.935|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||122.935|97.384|0.0303
74030258|NCT01505491|147614720|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|128.88|STANDARD_ERROR_OF_MEAN|1.08||0.6547|TWO_SIDED|90.0|113.492|146.365|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||146.365|113.492|0.6547
73932578|NCT01298063|147395020|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|90.61|STANDARD_DEVIATION|32.8||0.2309|TWO_SIDED|90.0|66.915|122.705||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||122.705|66.915|0.2309
73932579|NCT01298063|147395020|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|94.49|STANDARD_DEVIATION|32.4||0.1546|TWO_SIDED|90.0|71.563|124.764||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||124.764|71.563|0.1546
73932580|NCT03181542|147395028|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
73932581|NCT03181542|147395029|SUPERIORITY|||||||0.4|||||||Jonckheere-Terpstra Test|||||||0.40
73932582|NCT03181542|147395030|SUPERIORITY|||||||0.9|||||||Jonckheere-Terpstra Test|||||||0.90
73932583|NCT01071512|147395031|OTHER|||||||0.17|||||||Mixed Models Analysis|||Analysis used all available data from subjects, including those who dropped out early.||||0.17
73932584|NCT01071512|147395032|OTHER|||||||0.6|||||||Mixed Models Analysis|||Analysis used all available data||||0.6
73932585|NCT01071512|147395033|OTHER|||||||0.3|||||||Mixed Models Analysis|||Analysis used all available data||||0.3
73932586|NCT01071512|147395034|OTHER|||||||0.02|||||||Mixed Models Analysis|||Analysis used all available data||||0.02
74030259|NCT01505491|147614720|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.24|STANDARD_ERROR_OF_MEAN|1.077||0.1572|TWO_SIDED|90.0|76.238|97.564|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||97.564|76.238|0.1572
74088742|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.82|0.04|||Mixed Models Analysis|||8 hours postdose||0.04|-0.82|
73932587|NCT01071512|147395035|OTHER|||||||0.9|||||||Mixed Models Analysis|||Analysis used all available data||||0.9
73932588|NCT02076412|147395055|SUPERIORITY||Risk Difference (RD)|13.8||||0.1519|TWO_SIDED|95.0|0.5|27.1|||Fisher Exact||Confidence interval for treatment difference (risk difference) was based on the normal approximation|||27.1|0.5|0.1519
73932589|NCT02076412|147395060|SUPERIORITY||Risk Difference (RD)|-0.01||||0.4927|TWO_SIDED|95.0|-0.05|0.02||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.02|-0.05|0.4927
73932590|NCT02076412|147395061|SUPERIORITY||Risk Difference (RD)|-0.12||||0.2499|TWO_SIDED|95.0|-0.32|0.09||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.09|-0.32|0.2499
73932591|NCT00853658|147395074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.1724|TWO_SIDED|95.0|0.85|1.03|||Regression, Cox|||(superiority)||1.03|0.85|0.1724
73932592|NCT00853658|147395074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.4579|TWO_SIDED|95.0|0.85|1.07|||Regression, Cox|||(superiority) Non-Diabetic patients||1.07|0.85|0.4579
73932593|NCT00853658|147395074|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified Non-inferiority margin 1.104 is used.|Hazard Ratio (HR)|0.99||||0.0368|TWO_SIDED|95.0|0.9|1.1|||Regression, Cox|||||1.10|0.90|0.0368
73932594|NCT00853658|147395074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9118|TWO_SIDED|95.0|0.9|1.1|||Regression, Cox|||(superiority)||1.10|0.90|0.9118
73932595|NCT02797262|147395121|SUPERIORITY||Mean Difference (Net)|0.02||||0.57|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)||Treatment Difference = Intervention - Control|Compared the IPAM score between two groups.||||0.57
73932596|NCT02797262|147395123|SUPERIORITY||Mean Difference (Net)|-0.02||||0.08|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the change of the plasma HIV RNA levels during the intervention period (week 0-16) between two groups.||||0.08
73864459|NCT00652951|147275560|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 18C.|GMC ratio|1.61|||||TWO_SIDED|95.0|1.28|2.03|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over ), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 18C.||2.03|1.28|
73864460|NCT00652951|147275560|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 19F.|GMC ratio|1.06|||||TWO_SIDED|95.0|0.82|1.36|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 19F.||1.36|0.82|
73864461|NCT00652951|147275560|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 23F.|GMC ratio|0.92|||||TWO_SIDED|95.0|0.7|1.23|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa Group and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 23F.||1.23|0.7|
73864462|NCT00652951|147275561|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for protein D.|GMC ratio|0.91|||||TWO_SIDED|95.0|0.77|1.06|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns protein D.||1.06|0.77|
73932597|NCT02797262|147395123|SUPERIORITY||Mean Difference (Net)|-0.02||||0.23|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the change of the plasma HIV RNA levels during the post-intervention period (week 16-28) between two groups.||||0.23
73932598|NCT02797262|147395123|SUPERIORITY||Mean Difference (Net)|-0.73||||0.03|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the plasma HIV RNA levels during week 4-28 between two groups.||||0.03
73932599|NCT01312766|147395133|NON_INFERIORITY_OR_EQUIVALENCE|The one-way Analysis of Variance with Least-Squares means was performed to calculate the 95% Confidence Interval of the difference between the two treatments. If the lower bound of the 95% Confidence Interval of the difference between means (hMG-IBSA minus Menopur®) was greater than -2.1, then hMG-IBSA would be considered to be not-inferior to the comparator.|Mean Difference (Final Values)|1.9||||0.012|TWO_SIDED|95.0|0.43|3.43|||ANOVA|||||3.43|0.43|0.012
73932600|NCT01312766|147395134|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
73932601|NCT01312766|147395136|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Fisher Exact|||||||0.90
73971643|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-25.771|||<|0.0001|TWO_SIDED|95.0|-37.189|-14.353|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-14.353|-37.189|<.0001
74030260|NCT01505491|147614721|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|110.3|STANDARD_ERROR_OF_MEAN|1.063||0.0212|TWO_SIDED|90.0|99.687|122.035|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||122.035|99.687|0.0212
73864463|NCT01206582|147275603|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|||Comparison for day 3||||0.0002
73864464|NCT01206582|147275603|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANCOVA|||Comparison for day 7||||0.008
73864465|NCT01206582|147275604|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||Comparison for day 3||||0.0003
73864466|NCT01206582|147275611|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Comparison for Day 7||||<0.05
73864467|NCT01206582|147275612|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Comparison for Day 7||||<0.05
73864468|NCT01206582|147275613|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Comparison for Platelets on Day 4||||0.01
73932602|NCT01312766|147395137|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
73932603|NCT01312766|147395140|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||||||0.61
73932604|NCT01312766|147395141|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
73932605|NCT01312766|147395142|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
73932606|NCT01312766|147395143|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
73932607|NCT01312766|147395144|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||ANOVA|||||||0.04
73932608|NCT01312766|147395145|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||||||0.61
73932609|NCT03246529|147395167|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified Cochran-Mantel-Haenszel (CMH) test (by response status and baseline platelet count),||||||<0.0001
73932610|NCT03246529|147395168|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73864469|NCT01755455|147275614|SUPERIORITY_OR_OTHER|||||||0.81|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).||||0.81
73864470|NCT01755455|147275615|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fixed-effect model|||||||<0.05
73971644|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.019||||0.0005|TWO_SIDED|95.0|-32.833|-7.205|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-7.205|-32.833|0.0005
73971645|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-18.463||||0.0002|TWO_SIDED|95.0|-29.825|-7.101|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-7.101|-29.825|0.0002
73971646|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.997||||0.0002|TWO_SIDED|95.0|-33.619|-8.375|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-8.375|-33.619|0.0002
73971647|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.508|||<|0.0001|TWO_SIDED|95.0|-29.061|-11.955|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-11.955|-29.061|<.0001
74008250|NCT03627767|147566491|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.8|||Mixed Models Analysis|||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.8|-2.0|< 0.0001
74008251|NCT03627767|147566491|SUPERIORITY||LSM difference|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.3|||Mixed Models Analysis|||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.3|-2.5|< 0.0001
74008252|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.5|||||TWO_SIDED|95.0|-0.9|-0.1||||||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-0.9|
73932611|NCT03246529|147395169|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73932612|NCT03117387|147395207|OTHER|Bland-Altman analysis estimates bias between TOF-Cuff and electromyography.|bias|0.0|||||TWO_SIDED|0.05|-0.05|0.05||||||"Paired measurements were compared using a Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method\_agreement\_analysis, Leiden, the Netherlands).~This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects."||0.05|-0.05|
73932613|NCT01856140|147395209|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.52
73932614|NCT01856140|147395209|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.47
73932615|NCT01856140|147395209|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.52
73932616|NCT01856140|147395210|OTHER|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.227
73932617|NCT01856140|147395210|OTHER|||||||0.573|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.573
73932618|NCT01856140|147395210|OTHER|||||||0.588|||||||Wilcoxon (Mann-Whitney)|||||||0.588
73932619|NCT01856140|147395211|OTHER|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.262
73932620|NCT01856140|147395211|OTHER|||||||0.631|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.631
73864471|NCT01755455|147275616|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).||||<0.05
73864472|NCT01755455|147275617|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fixed-effect model|||||||0.16
73864473|NCT06359080|147275618|EQUIVALENCE|The difference between post treatment CARS scores and pre treatment CARS scores will be statistically significant as measured by independent sample t-test with p\<.05|Mean Difference (Net)|6.77|STANDARD_DEVIATION|5.5|<|0.05|TWO_SIDED|95.0|5.36|8.19||It's a calculated p-value.|t-test, 2 sided|||||8.19|5.36|<0.05
73864474|NCT01023672|147275653|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||The analysis was done per protocol (n=17)||||0.003
73864475|NCT02166463|147275683|SUPERIORITY|||||||0.0001|||||||Log Rank|Used a one-sided log-rank test between 2 arms||Assuming a 3-year EFS of 82% (5-year EFS of 78.4%, long term EFS of 76%) for standard arm, the study will have approximately 86% power for detecting an 8% improvement in 3-year EFS in the Bv-AVEPC arm (3-year EFS of 90%, 5-year EFS of 88.0%, long term EFS of 86.7%) in log rank test.||||0.0001
73864476|NCT00026312|147275748|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|2.6803||||0.1016|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.||||0.1016
73864477|NCT00026312|147275749|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|2.6176||||0.1057|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.||||0.1057
73864478|NCT00026312|147275752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.0262|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The number of courses of therapy delivered or patients randomized to Regimen B - RA + Immunotherapy and non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease, were compared using the Wilcoxon rank-sum test.||||0.0262
73864479|NCT00026312|147275753|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|3.4471||||0.0634|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.||||0.0634
73864480|NCT00026312|147275753|SUPERIORITY_OR_OTHER_LEGACY||Log-Rank Test Statistic|4.1362||||0.042|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.||||0.042
73864481|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||60.66|TWO_SIDED|95.0|0.85|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.85|60.66
73864482|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||95.21|TWO_SIDED|95.0|0.97|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.47|0.97|95.21
73864483|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||74.29|TWO_SIDED|95.0|0.88|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.88|74.29
73864484|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||99.48|TWO_SIDED|95.0|1.06|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.58|1.06|99.48
73864485|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||13.98|TWO_SIDED|95.0|0.66|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.66|13.98
73864486|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.28||||97.92|TWO_SIDED|95.0|1.01|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.62|1.01|97.92
73864487|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||80.24|TWO_SIDED|95.0|0.84|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.54|0.84|80.24
73932621|NCT01856140|147395211|OTHER|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.796
73864488|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.3||||97.79|TWO_SIDED|95.0|1.01|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.66|1.01|97.79
73864489|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||51.27|TWO_SIDED|95.0|0.81|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.81|51.27
73864490|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||90.66|TWO_SIDED|95.0|0.93|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.93|90.66
73864491|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||54.89|TWO_SIDED|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.90|54.89
73932622|NCT01856140|147395212|OTHER|||||||0.337|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.337
73932623|NCT01856140|147395212|OTHER|||||||0.078|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks||||0.078
73864492|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||94.45|TWO_SIDED|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.98|94.45
73864493|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||94.09|TWO_SIDED|95.0|0.98|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.98|94.09
73932624|NCT01856140|147395212|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.439
73932625|NCT02139644|147395213|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.154||||0.0076|TWO_SIDED|95.0|0.041|0.267|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.||0.267|0.041|0.0076
73957797|NCT00383188|147451053|SUPERIORITY||LSM Difference|0.792|STANDARD_ERROR_OF_MEAN|1.093||0.4693|TWO_SIDED|95.0|-1.357|2.941|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||2.941|-1.357|0.4693
73957798|NCT00383188|147451053|SUPERIORITY||LSM Difference|1.927|STANDARD_ERROR_OF_MEAN|1.077||0.0743|TWO_SIDED|95.0|-0.19|4.044|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||4.044|-0.190|0.0743
73957799|NCT00383188|147451053|SUPERIORITY||LSM Difference|4.196|STANDARD_ERROR_OF_MEAN|1.286||0.0012|TWO_SIDED|95.0|1.668|6.723|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||6.723|1.668|0.0012
73957800|NCT00383188|147451053|SUPERIORITY||LSM Difference|1.236|STANDARD_ERROR_OF_MEAN|1.308||0.3452|TWO_SIDED|95.0|-1.335|3.807|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||3.807|-1.335|0.3452
73957801|NCT00383188|147451053|SUPERIORITY||LSM Difference|1.095|STANDARD_ERROR_OF_MEAN|1.091||0.3162|TWO_SIDED|95.0|-1.05|3.239|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||3.239|-1.050|0.3162
73957802|NCT00383188|147451053|SUPERIORITY||LSM Difference|2.514|STANDARD_ERROR_OF_MEAN|1.072||0.0195|TWO_SIDED|95.0|0.406|4.622|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||4.622|0.406|0.0195
73957803|NCT00383188|147451053|SUPERIORITY||LSM Difference|2.762|STANDARD_ERROR_OF_MEAN|1.283||0.032|TWO_SIDED|95.0|0.239|5.285|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||5.285|0.239|0.0320
73864494|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||62.95|TWO_SIDED|95.0|0.91|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.91|62.95
73864495|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||96.86|TWO_SIDED|95.0|0.99|1.26||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.26|0.99|96.86
73864496|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||94.16|TWO_SIDED|95.0|0.98|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.98|94.16
73864497|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.99|TWO_SIDED|95.0|0.86|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.86|48.99
73864498|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||94.51|TWO_SIDED|95.0|0.98|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.98|94.51
73864499|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||94.59|TWO_SIDED|95.0|0.97|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.97|94.59
74030261|NCT01505491|147614721|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|117.53|STANDARD_ERROR_OF_MEAN|1.066||0.17|TWO_SIDED|90.0|105.638|130.757|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||130.757|105.638|0.1700
73864500|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||61.27|TWO_SIDED|95.0|0.86|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.86|61.27
73864501|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||96.63|TWO_SIDED|95.0|0.99|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.34|0.99|96.63
73864502|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||94.02|TWO_SIDED|95.0|0.97|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.97|94.02
73864503|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||53.24|TWO_SIDED|95.0|0.87|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.87|53.24
73932626|NCT02139644|147395213|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.131||||0.0322|TWO_SIDED|95.0|0.011|0.25|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.||0.250|0.011|0.0322
73932627|NCT02139644|147395213|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.335||||0|TWO_SIDED|95.0|0.216|0.453|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.||0.453|0.216|0.0000
73864504|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||70.84|TWO_SIDED|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.91|70.84
73864505|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||74.15|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|74.15
73864506|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||65.43|TWO_SIDED|95.0|0.87|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.87|65.43
73864507|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||97.15|TWO_SIDED|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.99|97.15
73864508|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||63.99|TWO_SIDED|95.0|0.81|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.34|0.81|63.99
73864509|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||91.99|TWO_SIDED|95.0|0.94|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|0.94|91.99
73864510|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||76.81|TWO_SIDED|95.0|0.94|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.94|76.81
74030262|NCT01505491|147614721|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|96.53|STANDARD_ERROR_OF_MEAN|1.064||0.0016|TWO_SIDED|90.0|87.064|107.017|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||107.017|87.064|0.0016
74088743|NCT03465436|147730588|SUPERIORITY||LS Mean|-0.31|||||TWO_SIDED|90.0|-0.7|0.09|||Mixed Models Analysis|||12 hours postdose||0.09|-0.70|
73864511|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||67.01|TWO_SIDED|95.0|0.95|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Central; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.95|67.01
73864512|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||63.91|TWO_SIDED|95.0|0.85|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.85|63.91
73864513|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.18||||96.47|TWO_SIDED|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.99|96.47
73957804|NCT00383188|147451053|SUPERIORITY||LSM Difference|0.268|STANDARD_ERROR_OF_MEAN|1.29||0.8356|TWO_SIDED|95.0|-2.268|2.804|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||2.804|-2.268|0.8356
73957805|NCT00383188|147451053|SUPERIORITY||LSM Difference|-0.904|STANDARD_ERROR_OF_MEAN|1.626||0.5787|TWO_SIDED|95.0|-4.101|2.293|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||2.293|-4.101|0.5787
73864514|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||72.17|TWO_SIDED|95.0|0.93|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.93|72.17
73864515|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||74.38|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|74.38
73864516|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||53.85|TWO_SIDED|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.90|53.85
73864517|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||95.02|TWO_SIDED|95.0|0.98|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.98|95.02
73864518|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||92.27|TWO_SIDED|95.0|0.97|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.97|92.27
73864519|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||54.65|TWO_SIDED|95.0|0.88|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.88|54.65
73864520|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||87.93|TWO_SIDED|95.0|0.95|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.95|87.93
73864521|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||77.57|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|77.57
73864522|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||77.07|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|77.07
74030263|NCT02759146|147614724|SUPERIORITY||Difference between least squared means|0.09||||0.72|TWO_SIDED|95.0|-0.36|0.52||Adjusted for baseline and balancing factors used in the randomization|Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||.52|-.36|.72
74088744|NCT03465436|147730588|SUPERIORITY||LS Mean|0.19|||||TWO_SIDED|90.0|-0.23|0.61|||Mixed Models Analysis|||24 hours postdose||0.61|-0.23|
73864523|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||78.42|TWO_SIDED|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.96|78.42
73957806|NCT00383188|147451053|SUPERIORITY||LSM Difference|1.291|STANDARD_ERROR_OF_MEAN|1.6||0.4203|TWO_SIDED|95.0|-1.854|4.436|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||4.436|-1.854|0.4203
73957807|NCT00383188|147451053|SUPERIORITY||LSM Difference|2.318|STANDARD_ERROR_OF_MEAN|1.916||0.2272|TWO_SIDED|95.0|-1.449|6.084|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||6.084|-1.449|0.2272
73864524|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||44.15|TWO_SIDED|95.0|0.93|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.93|44.15
73864525|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.79|TWO_SIDED|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.89|52.79
73864526|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||94.51|TWO_SIDED|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.98|94.51
73864527|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||93.16|TWO_SIDED|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.98|93.16
73864528|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||73.7|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|73.70
73864529|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||81.04|TWO_SIDED|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.96|81.04
73864530|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.58|TWO_SIDED|95.0|0.94|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.94|52.58
73864531|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||15.85|TWO_SIDED|95.0|0.86|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.86|15.85
73864532|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.69|TWO_SIDED|95.0|0.9|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.90|48.69
73864533|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.25|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|52.25
73864534|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||66.48|TWO_SIDED|95.0|0.91|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.91|66.48
73864535|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||9.12|TWO_SIDED|95.0|0.72|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.72|9.12
74088745|NCT03465436|147730589|SUPERIORITY||LS Mean|-1.53|||||TWO_SIDED|90.0|-2.9|-0.16|||Mixed Models Analysis|||30 minutes postdose||-0.16|-2.90|
73864536|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||16.95|TWO_SIDED|95.0|0.78|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.78|16.95
73864537|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||0.89|TWO_SIDED|95.0|0.75|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.75|0.89
73864538|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.4|TWO_SIDED|95.0|0.86|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.86|50.40
73864539|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||7.44|TWO_SIDED|95.0|0.76|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.76|7.44
73864540|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||56.35|TWO_SIDED|95.0|0.87|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.87|56.35
74008253|NCT03627767|147566491|SUPERIORITY||LSM difference|-1.0|||=|0.0039|TWO_SIDED|95.0|-1.7|-0.3|||Mixed Models Analysis|||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.7|= 0.0039
73864541|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||4.03|TWO_SIDED|95.0|0.87|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.87|4.03
73864542|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||24.79|TWO_SIDED|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.89|24.79
73864543|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||77.08|TWO_SIDED|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.95|77.08
73864544|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||23.07|TWO_SIDED|95.0|0.89|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.89|23.07
73864545|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||18.58|TWO_SIDED|95.0|0.88|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.88|18.58
73864546|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||44.94|TWO_SIDED|95.0|0.92|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.92|44.94
74008254|NCT03627767|147566491|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.2|||Mixed Models Analysis|||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.2|-2.5|< 0.0001
73864547|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||2.21|TWO_SIDED|95.0|0.8|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.00|0.80|2.21
73864548|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||6.09|TWO_SIDED|95.0|0.83|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.83|6.09
73864549|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||66.6|TWO_SIDED|95.0|0.92|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.92|66.60
73864550|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||3.23|TWO_SIDED|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.81|3.23
73864551|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||20.83|TWO_SIDED|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.86|20.83
73864552|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||87.6|TWO_SIDED|95.0|0.96|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.96|87.60
74030264|NCT02759146|147614724|SUPERIORITY||Difference between least squared means|-0.15||||0.58|TWO_SIDED|95.0|-0.72|0.41|||Mixed Models Analysis||Difference between reflexology and control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||.41|-.72|.58
73864553|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||7.9|TWO_SIDED|95.0|0.84|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.84|7.90
73864554|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||23.39|TWO_SIDED|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.87|23.39
73864555|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||76.16|TWO_SIDED|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.95|76.16
73932628|NCT02139644|147395213|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.325||||0|TWO_SIDED|95.0|0.203|0.447|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.||0.447|0.203|0.0000
73932629|NCT02139644|147395214|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.262||||0|TWO_SIDED|95.0|0.168|0.356|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.||0.356|0.168|0.0000
73932630|NCT02139644|147395214|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.266||||0|TWO_SIDED|95.0|0.172|0.36|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.||0.360|0.172|0.0000
74030265|NCT02759146|147614724|SUPERIORITY||Difference between least squared means|-0.24||||0.42|TWO_SIDED|95.0|-0.81|0.34|||Mixed Models Analysis||Difference between meditative practice and control for weeks 1-4|Aim 1: Comparing meditative practices vs control for weeks 1-4||.34|-.81|.42
73864556|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||22.54|TWO_SIDED|95.0|0.87|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.87|22.54
73932631|NCT02139644|147395214|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.151||||0.0017|TWO_SIDED|95.0|0.057|0.244|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.||0.244|0.057|0.0017
73932632|NCT02139644|147395214|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.119||||0.0132|TWO_SIDED|95.0|0.025|0.212|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.||0.212|0.025|0.0132
73932633|NCT02139644|147395215|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|10.926||||0.0123|TWO_SIDED|95.0|2.38|19.471||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.471|2.380|0.0123
73932634|NCT02139644|147395215|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|7.018||||0.1074|TWO_SIDED|95.0|-1.531|15.567||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||15.567|-1.531|0.1074
73932635|NCT02139644|147395215|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|20.824||||0|TWO_SIDED|95.0|12.253|29.395||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||29.395|12.253|0.0000
73932636|NCT02139644|147395215|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.273||||0|TWO_SIDED|95.0|12.728|29.818||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||29.818|12.728|0.0000
73932637|NCT02139644|147395215|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|9.898||||0.0233|TWO_SIDED|95.0|1.349|18.447||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||18.447|1.349|0.0233
73932638|NCT02139644|147395215|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|14.255||||0.0011|TWO_SIDED|95.0|5.732|22.778||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||22.778|5.732|0.0011
73932639|NCT02139644|147395215|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|10.347||||0.0175|TWO_SIDED|95.0|1.822|18.872||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||18.872|1.822|0.0175
73971648|NCT04800211|147483701|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.978||||0.8504|TWO_SIDED|95.0|-9.216|11.172|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||11.172|-9.216|0.8504
74008255|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.3|-0.4||||||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-1.3|
74030266|NCT02759146|147614725|SUPERIORITY||Difference between least squared means|-0.01||||0.96|TWO_SIDED|95.0|-0.44|0.42|||Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||0.42|-0.44|0.96
73864557|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||58.17|TWO_SIDED|95.0|0.91|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.91|58.17
73864558|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||6.22|TWO_SIDED|95.0|0.76|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.76|6.22
73864559|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||55.85|TWO_SIDED|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.88|55.85
73864560|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.44|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|25.44
73864561|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||18.15|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|18.15
73864562|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||8.12|TWO_SIDED|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.82|8.12
73864563|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||57.39|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|57.39
74008256|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.5|||=|0.1488|TWO_SIDED|95.0|-1.2|0.2|||Mixed Models Analysis|||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-1.2|= 0.1488
73864564|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||10|TWO_SIDED|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.93|10.00
73864565|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||29.88|TWO_SIDED|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.95|29.88
73864566|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||12.63|TWO_SIDED|95.0|0.89|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.89|12.63
73864567|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||32.29|TWO_SIDED|95.0|0.91|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.91|32.29
73864568|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||69.92|TWO_SIDED|95.0|0.95|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.95|69.92
73864569|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||6.1|TWO_SIDED|95.0|0.84|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.84|6.10
73864570|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||33.63|TWO_SIDED|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.89|33.63
73864571|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||86.07|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|86.07
73932640|NCT02139644|147395216|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.165||||0.0002|TWO_SIDED|95.0|-0.251|-0.08||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.080|-0.251|0.0002
73932641|NCT02139644|147395216|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.143||||0.001|TWO_SIDED|95.0|-0.229|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.058|-0.229|0.0010
73932642|NCT02139644|147395216|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.23||||0|TWO_SIDED|95.0|-0.315|-0.144||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.144|-0.315|0.0000
73932643|NCT02139644|147395216|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.194||||0|TWO_SIDED|95.0|-0.279|-0.109||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.109|-0.279|0.0000
74088746|NCT03465436|147730589|SUPERIORITY||LS Mean|-5.09|||||TWO_SIDED|90.0|-6.29|-3.88|||Mixed Models Analysis|||1 hour postdose||-3.88|-6.29|
73864572|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||41.38|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|41.38
73864573|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||24.88|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|24.88
73932644|NCT02139644|147395216|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.064||||0.1381|TWO_SIDED|95.0|-0.15|0.021||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.021|-0.150|0.1381
73932645|NCT02139644|147395216|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.051||||0.2438|TWO_SIDED|95.0|-0.136|0.035||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.035|-0.136|0.2438
73932646|NCT02139644|147395216|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.029||||0.5095|TWO_SIDED|95.0|-0.114|0.057||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.057|-0.114|0.5095
73864574|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||29.89|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|29.89
73864575|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||7.13|TWO_SIDED|95.0|0.87|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.87|7.13
73864576|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||32.91|TWO_SIDED|95.0|0.9|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.90|32.91
73864577|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||81.15|TWO_SIDED|95.0|0.96|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.96|81.15
73864578|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||21.87|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|21.87
73864579|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||24.49|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|24.49
73864580|NCT02294734|147275791|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||55.52|TWO_SIDED|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.97|55.52
74030267|NCT02759146|147614725|SUPERIORITY||Difference between least squared means|-0.2||||0.48|TWO_SIDED|95.0|-0.75|0.35|||Mixed Models Analysis||Difference between reflexology and control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||0.35|-0.75|0.48
74030268|NCT02759146|147614725|SUPERIORITY||Difference between least squared means|-0.19||||0.52|TWO_SIDED|95.0|-0.75|0.38|||Mixed Models Analysis||Difference between meditative practice and control for weeks 1-4|Aim 1: Comparing meditative practice vs control for weeks 1-4||0.38|-0.75|0.52
73864581|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||59.55|TWO_SIDED|95.0|0.84|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.84|59.55
73864582|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.18||||94.01|TWO_SIDED|95.0|0.96|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.96|94.01
73864583|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||82.27|TWO_SIDED|95.0|0.9|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.33|0.90|82.27
73932647|NCT02139644|147395217|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.463||||0.0004|TWO_SIDED|95.0|-0.716|-0.209||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.209|-0.716|0.0004
74030269|NCT02759146|147614726|SUPERIORITY||Difference between least squared means|0.67||||0.68|TWO_SIDED|95.0|-2.52|3.86|||Mixed Models Analysis||Comparing reflexology to meditative practices for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||3.86|-2.52|.68
73864584|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.31||||99.22|TWO_SIDED|95.0|1.06|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|1.06|99.22
73864585|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||46.24|TWO_SIDED|95.0|0.75|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.75|46.24
73864586|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||98.3|TWO_SIDED|95.0|1.02|1.64||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.64|1.02|98.30
73864587|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.25||||92.6|TWO_SIDED|95.0|0.92|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|0.92|92.60
73864588|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.38||||99.01|TWO_SIDED|95.0|1.05|1.81||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.81|1.05|99.01
73864589|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||58.8|TWO_SIDED|95.0|0.82|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.82|58.80
73864590|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||86.82|TWO_SIDED|95.0|0.91|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.91|86.82
73864591|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||67.37|TWO_SIDED|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.92|67.37
73864592|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||98.35|TWO_SIDED|95.0|1.01|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|1.01|98.35
73864593|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||96.86|TWO_SIDED|95.0|0.99|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.99|96.86
74008257|NCT03627767|147566491|SUPERIORITY||LSM difference|-1.3|||=|0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-2.0|= 0.0003
74008258|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.2|-0.3||||||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.2|
73864594|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||86.18|TWO_SIDED|95.0|0.95|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.95|86.18
73864595|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.16||||98.89|TWO_SIDED|95.0|1.02|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|1.02|98.89
73864596|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||91.94|TWO_SIDED|95.0|0.97|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.97|91.94
73864597|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||55.32|TWO_SIDED|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.88|55.32
73864598|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||97.17|TWO_SIDED|95.0|1.0|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|1.00|97.17
73864599|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||96.57|TWO_SIDED|95.0|0.99|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.99|96.57
73864600|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||79.13|TWO_SIDED|95.0|0.9|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.90|79.13
73864601|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||99.54|TWO_SIDED|95.0|1.05|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|1.05|99.54
73864602|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||97.8|TWO_SIDED|95.0|1.0|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.30|1.00|97.80
73864603|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||71.94|TWO_SIDED|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.91|71.94
73864604|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||85.3|TWO_SIDED|95.0|0.94|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.94|85.30
73864605|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||82.15|TWO_SIDED|95.0|0.94|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.94|82.15
73932648|NCT02139644|147395217|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.464||||0.0003|TWO_SIDED|95.0|-0.718|-0.211||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.211|-0.718|0.0003
74030270|NCT02759146|147614726|SUPERIORITY||Difference between least squared means|-2.53||||0.23|TWO_SIDED|95.0|-6.64|1.58|||Mixed Models Analysis||Comparing reflexology to control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||1.58|-6.64|.23
73864606|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||72.55|TWO_SIDED|95.0|0.88|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.88|72.55
73864607|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||98.44|TWO_SIDED|95.0|1.02|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.47|1.02|98.44
73864608|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.11||||78.24|TWO_SIDED|95.0|0.86|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.86|78.24
73864609|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.23||||96.8|TWO_SIDED|95.0|0.99|1.52||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.52|0.99|96.80
74030271|NCT02759146|147614726|SUPERIORITY||Difference between least squared means|-3.2||||0.14|TWO_SIDED|95.0|-7.41|1.01|||Mixed Models Analysis||Comparing meditative practice to control for weeks 1-4|Aim 1: Comparing meditative practice vs control for weeks 1-4||1.01|-7.41|0.14
73864610|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||91.11|TWO_SIDED|95.0|0.97|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.97|91.11
73864611|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||89.3|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|89.30
73864612|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||74.67|TWO_SIDED|95.0|0.87|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.87|74.67
74030272|NCT02759146|147614727|SUPERIORITY||Difference between least squared means|0.01||||0.98|TWO_SIDED|95.0|-0.38|0.39|||Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||0.39|-0.38|0.98
73864613|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.23||||98.25|TWO_SIDED|95.0|1.02|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|1.02|98.25
73864614|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||87.8|TWO_SIDED|95.0|0.96|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.96|87.80
73864615|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||91.54|TWO_SIDED|95.0|0.97|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.97|91.54
74088747|NCT03465436|147730589|SUPERIORITY||LS Mean|-5.57|||||TWO_SIDED|90.0|-6.81|-4.32|||Mixed Models Analysis|||1.5 hours postdose||-4.32|-6.81|
74088748|NCT03465436|147730589|SUPERIORITY||LS Mean|-4.01|||||TWO_SIDED|90.0|-5.0|-3.01|||Mixed Models Analysis|||2 hours postdose||-3.01|-5.00|
74088749|NCT03465436|147730589|SUPERIORITY||LS Mean|-4.78|||||TWO_SIDED|90.0|-5.91|-3.65|||Mixed Models Analysis|||2.5 hours postdose||-3.65|-5.91|
74088750|NCT03465436|147730589|SUPERIORITY||LS Mean|-4.14|||||TWO_SIDED|90.0|-5.2|-3.08|||Mixed Models Analysis|||3 hours postdose||-3.08|-5.20|
74088751|NCT03465436|147730589|SUPERIORITY||LS Mean|-2.94|||||TWO_SIDED|90.0|-3.87|-2.01|||Mixed Models Analysis|||3.5 hours postdose||-2.01|-3.87|
73932649|NCT02139644|147395217|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.675||||0|TWO_SIDED|95.0|-0.928|-0.421||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.421|-0.928|0.0000
73932650|NCT02139644|147395217|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.704||||0|TWO_SIDED|95.0|-0.957|-0.45||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.450|-0.957|0.0000
73864616|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||68.89|TWO_SIDED|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.92|68.89
73864617|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||98.19|TWO_SIDED|95.0|1.01|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|1.01|98.19
73864618|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||94.07|TWO_SIDED|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.98|94.07
73864619|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||75.74|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|75.74
73864620|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||95.83|TWO_SIDED|95.0|0.99|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.99|95.83
73864621|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||79.8|TWO_SIDED|95.0|0.94|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.94|79.80
73864622|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||95.29|TWO_SIDED|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.99|95.29
73864623|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||96.27|TWO_SIDED|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.99|96.27
73864624|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.62|TWO_SIDED|95.0|0.94|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.94|47.62
73864625|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||71.55|TWO_SIDED|95.0|0.92|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.92|71.55
74030273|NCT02759146|147614727|SUPERIORITY||Difference between least squared means|-0.24||||0.34|TWO_SIDED|95.0|-0.74|0.25|||Mixed Models Analysis||Comparing reflexology to control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||0.25|-0.74|0.34
73864626|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||98.29|TWO_SIDED|95.0|1.01|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|1.01|98.29
73864627|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Bayesian repeated measures model|1.08||||95.09|TWO_SIDED|95.0|0.99|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.99|95.09
73864628|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||93.68|TWO_SIDED|95.0|0.98|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.98|93.68
73864629|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||96.58|TWO_SIDED|95.0|1.0|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|1.00|96.58
73864630|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||56.99|TWO_SIDED|95.0|0.95|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.95|56.99
73864631|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||13.08|TWO_SIDED|95.0|0.85|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.85|13.08
73864632|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.99|TWO_SIDED|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.89|52.99
73864633|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||60.75|TWO_SIDED|95.0|0.9|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.90|60.75
73864634|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||75.23|TWO_SIDED|95.0|0.92|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.92|75.23
73864635|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||28.14|TWO_SIDED|95.0|0.78|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.78|28.14
73864636|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||38.43|TWO_SIDED|95.0|0.84|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.84|38.43
73864637|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||25.21|TWO_SIDED|95.0|0.8|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.80|25.21
74088752|NCT03465436|147730589|SUPERIORITY||LS Mean|-2.42|||||TWO_SIDED|90.0|-3.42|-1.42|||Mixed Models Analysis|||4 hours postdose||-1.42|-3.42|
73864638|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||81.73|TWO_SIDED|95.0|0.91|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.91|81.73
73864639|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||9.87|TWO_SIDED|95.0|0.76|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.76|9.87
73864640|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||63.15|TWO_SIDED|95.0|0.87|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.87|63.15
73864641|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||4.03|TWO_SIDED|95.0|0.86|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.86|4.03
73864642|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||30.03|TWO_SIDED|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.89|30.03
73864643|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||80.34|TWO_SIDED|95.0|0.95|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.95|80.34
73864644|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||25.65|TWO_SIDED|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.89|25.65
73932651|NCT02139644|147395217|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.212||||0.1014|TWO_SIDED|95.0|-0.465|0.042||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.042|-0.465|0.1014
73932652|NCT02139644|147395217|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.239||||0.064|TWO_SIDED|95.0|-0.492|0.014||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.014|-0.492|0.0640
73932653|NCT02139644|147395217|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.241||||0.0626|TWO_SIDED|95.0|-0.494|0.013||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.013|-0.494|0.0626
74030274|NCT02759146|147614727|SUPERIORITY||Difference between least squared means|-0.25||||0.34|TWO_SIDED|95.0|-0.76|0.26|||Mixed Models Analysis||Comparing meditative practices vs control for weeks 1-4|Aim 1: Comparing meditative practices vs control for weeks 1-4||0.26|-0.76|0.34
73864645|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||24.36|TWO_SIDED|95.0|0.88|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.88|24.36
73864646|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.45|TWO_SIDED|95.0|0.91|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.91|48.45
73864647|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||1.95|TWO_SIDED|95.0|0.81|0.99||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.99|0.81|1.95
73864648|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||14.15|TWO_SIDED|95.0|0.85|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.85|14.15
73864649|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||80.61|TWO_SIDED|95.0|0.95|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.95|80.61
73864650|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||3.3|TWO_SIDED|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.81|3.30
73864651|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||42.22|TWO_SIDED|95.0|0.88|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.88|42.22
73864652|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||95.24|TWO_SIDED|95.0|0.99|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.99|95.24
73864653|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||6.38|TWO_SIDED|95.0|0.83|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.83|6.38
73864654|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||28.82|TWO_SIDED|95.0|0.86|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.86|28.82
73864655|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||87.39|TWO_SIDED|95.0|0.97|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.97|87.39
73932654|NCT02139644|147395218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679||||||Significance level of 0.05|Log Rank|||||||0.1679
73932655|NCT02139644|147395218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1701||||||Significance level of 0.05|Log Rank|||||||0.1701
73932656|NCT02139644|147395218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0437||||||Significance level of 0.05|Log Rank|||||||0.0437
73932657|NCT02139644|147395218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1718||||||Significance level of 0.05|Log Rank|||||||0.1718
73932658|NCT02139644|147395218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3134||||||Significance level of 0.05|Log Rank|||||||0.3134
73932659|NCT02139644|147395218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.993||||||Significance level of 0.05|Log Rank|||||||0.9930
73932660|NCT02139644|147395218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9999||||||Significance level of 0.05|Log Rank|||||||0.9999
73932661|NCT02139644|147395219|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.301||||0.0044|TWO_SIDED|95.0|0.094|0.508||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.508|0.094|0.0044
73932662|NCT02139644|147395219|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.253||||0.0155|TWO_SIDED|95.0|0.048|0.458||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.458|0.048|0.0155
74088753|NCT03465436|147730589|SUPERIORITY||LS Mean|-4.61|||||TWO_SIDED|90.0|-6.17|-3.06|||Mixed Models Analysis|||6 hours postdose||-3.06|-6.17|
73864656|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||23.27|TWO_SIDED|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.87|23.27
73864657|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||57.82|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|57.82
73864658|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||9.67|TWO_SIDED|95.0|0.77|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.77|9.67
73864659|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||70.73|TWO_SIDED|95.0|0.89|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.89|70.73
73864660|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.61|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|25.61
73864661|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||44.1|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|44.10
73864662|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||10.14|TWO_SIDED|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.82|10.14
73864663|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||62.87|TWO_SIDED|95.0|0.9|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.90|62.87
73864664|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||11.82|TWO_SIDED|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.93|11.82
73932663|NCT02139644|147395219|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.473||||0|TWO_SIDED|95.0|0.27|0.676||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.676|0.270|0.0000
73932664|NCT02139644|147395219|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.23||||0.0293|TWO_SIDED|95.0|0.023|0.437||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.437|0.023|0.0293
73932665|NCT02139644|147395219|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.172||||0.0913|TWO_SIDED|95.0|-0.028|0.372||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.372|-0.028|0.0913
73932666|NCT02139644|147395219|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.023||||0.8216|TWO_SIDED|95.0|-0.223|0.177||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.177|-0.223|0.8216
73864665|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||51.44|TWO_SIDED|95.0|0.95|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.95|51.44
73864666|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||9.54|TWO_SIDED|95.0|0.88|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.88|9.54
73864667|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||30.03|TWO_SIDED|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.89|30.03
73864668|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||73.03|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|73.03
73864669|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||4.64|TWO_SIDED|95.0|0.83|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.83|4.64
73864670|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||42.13|TWO_SIDED|95.0|0.89|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.89|42.13
73864671|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||93.33|TWO_SIDED|95.0|0.98|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.98|93.33
73864672|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||27.33|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|27.33
73864673|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||34.15|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|34.15
73864674|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||58.42|TWO_SIDED|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.98|58.42
73932667|NCT02139644|147395219|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.071||||0.4934|TWO_SIDED|95.0|-0.275|0.133||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.133|-0.275|0.4934
73932668|NCT03328897|147395222|SUPERIORITY||Mean Difference (Net)|-4.23|STANDARD_ERROR_OF_MEAN|0.746|<|0.001|TWO_SIDED|95.0|-5.7|-2.77|||Mixed Model with Repeated Measures(MMRM)|||||-2.77|-5.70|<0.001
73932669|NCT03328897|147395222|SUPERIORITY||Mean Difference (Net)|-3.79|STANDARD_ERROR_OF_MEAN|0.738|<|0.001|TWO_SIDED|95.0|-5.24|-2.33|||Mixed Model with Repeated Measures(MMRM)|||||-2.33|-5.24|<0.001
73932670|NCT03328897|147395223|SUPERIORITY||Mean Difference (Net)|-10.19|STANDARD_ERROR_OF_MEAN|1.555|<|0.001|TWO_SIDED|95.0|-13.25|-7.14|||Mixed Model with Repeated Measures(MMRM)|||||-7.14|-13.25|<0.001
73932671|NCT03328897|147395223|SUPERIORITY||Mean Difference (Net)|-9.12|STANDARD_ERROR_OF_MEAN|1.535|<|0.001|TWO_SIDED|95.0|-12.14|-6.1|||Mixed Model with Repeated Measures(MMRM)|||||-6.10|-12.14|<0.001
73864675|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||5.93|TWO_SIDED|95.0|0.86|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.86|5.93
73864676|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||35.88|TWO_SIDED|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.89|35.88
73864677|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||86.41|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|86.41
73932672|NCT03328897|147395224|SUPERIORITY||Mean Difference (Net)|-5.92|STANDARD_ERROR_OF_MEAN|0.853|<|0.001|TWO_SIDED|95.0|-7.59|-4.24|||Mixed Model with Repeated Measures(MMRM)|||||-4.24|-7.59|<0.001
73932673|NCT03328897|147395224|SUPERIORITY||Mean Difference (Net)|-5.35|STANDARD_ERROR_OF_MEAN|0.842|<|0.001|TWO_SIDED|95.0|-7.0|-3.69|||Mixed Model with Repeated Measures(MMRM)|||||-3.69|-7.00|<0.001
73932674|NCT03328897|147395225|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|3.27|15.06|||Regression, Logistic|||||15.06|3.27|<0.001
73932675|NCT03328897|147395225|SUPERIORITY||Odds Ratio (OR)|7.03|||<|0.001|TWO_SIDED|95.0|3.29|15.06|||Regression, Logistic|||||15.06|3.29|<0.001
73932676|NCT03328897|147395226|SUPERIORITY||Odds Ratio (OR)|11.21|||<|0.001|TWO_SIDED|95.0|3.88|32.37|||Regression, Logistic|||||32.37|3.88|<0.001
73932677|NCT03328897|147395226|SUPERIORITY||Odds Ratio (OR)|5.88||||0.001|TWO_SIDED|95.0|2.01|17.17|||Regression, Logistic|||||17.17|2.01|0.001
73932678|NCT03328897|147395227|SUPERIORITY||Odds Ratio (OR)|2.73|||<|0.001|TWO_SIDED|95.0|1.51|4.95|||Regression, Logistic|||||4.95|1.51|<0.001
73932679|NCT03328897|147395227|SUPERIORITY||Odds Ratio (OR)|2.53||||0.002|TWO_SIDED|95.0|1.41|4.56|||Regression, Logistic|||||4.56|1.41|0.002
73932680|NCT03328897|147395228|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-5.7|-2.3|||Mixed Model with Repeated Measures(MMRM)|||||-2.3|-5.7|<0.001
73932681|NCT03328897|147395228|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-5.1|-1.8|||Mixed Model with Repeated Measures(MMRM)|||||-1.8|-5.1|<0.001
73932682|NCT03328897|147395229|SUPERIORITY||Hazard Ratio (HR)|1.71|||<|0.001|TWO_SIDED|95.0|1.25|2.33|||Regression, Cox|||||2.33|1.25|<0.001
73932683|NCT03328897|147395229|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.001|TWO_SIDED|95.0|1.22|2.25|||Regression, Cox|||||2.25|1.22|0.001
73932684|NCT05036642|147395251|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.02
73932685|NCT05036642|147395252|OTHER|||||||0.01|||||||ANOVA|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.01
73932686|NCT05036642|147395253|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.48
73932687|NCT02391948|147395311|OTHER||mean population value age 12|98.3|||||TWO_SIDED|95.0|97.8|98.6||||||||98.6|97.8|
73932688|NCT02391948|147395311|OTHER||mean population value age 12|89.1|||||TWO_SIDED|95.0|86.6|91.1||||||||91.1|86.6|
73932689|NCT02391948|147395311|OTHER||mean population value age 12|50.1|||||TWO_SIDED|95.0|46.5|53.6||||||||53.6|46.5|
73932690|NCT02391948|147395311|OTHER||mean population value age 12|25.3|||||TWO_SIDED|95.0|23.7|27.0||||||||27.0|23.7|
73932691|NCT02391948|147395311|OTHER||mean population value age 12|6.48|||||TWO_SIDED|95.0|5.66|7.38||||||||7.38|5.66|
73932692|NCT02391948|147395312|OTHER||mean population value age 12|0.44|||||TWO_SIDED|95.0|0.38|0.49||||||||0.49|0.38|
73932693|NCT02391948|147395312|OTHER||mean population value age 12|0.68|||||TWO_SIDED|95.0|0.6|0.77||||||||0.77|0.60|
73932694|NCT02391948|147395312|OTHER||mean population value age 12|0.93|||||TWO_SIDED|95.0|0.79|1.07||||||||1.07|0.79|
73932695|NCT02391948|147395312|OTHER||mean population value age 12|1.38|||||TWO_SIDED|95.0|1.22|1.54||||||||1.54|1.22|
73932696|NCT02391948|147395312|OTHER||mean population value age 12|2.16|||||TWO_SIDED|95.0|2.01|2.31||||||||2.31|2.01|
73932697|NCT02391948|147395313|OTHER||mean population value|4.49|||||TWO_SIDED|95.0|4.43|4.54||||||||4.54|4.43|
73932698|NCT02391948|147395313|OTHER||mean population value|4.1|||||TWO_SIDED|95.0|3.99|4.2||||||||4.20|3.99|
73932699|NCT02391948|147395313|OTHER||mean population value|3.99|||||TWO_SIDED|95.0|3.75|4.25||||||||4.25|3.75|
73932700|NCT02391948|147395313|OTHER||mean population value|2.95|||||TWO_SIDED|95.0|2.73|3.19||||||||3.19|2.73|
73932701|NCT02391948|147395313|OTHER||mean population value|1.59|||||TWO_SIDED|95.0|1.44|1.75||||||||1.75|1.44|
73932702|NCT02391948|147395314|OTHER||mean population value|1362.3|||||TWO_SIDED|95.0|1313.6|1410.7||||||||1410.7|1313.6|
73932703|NCT02391948|147395314|OTHER||mean population value|1096.33|||||TWO_SIDED|95.0|1028.8|1158.62||||||||1158.62|1028.80|
73932704|NCT02391948|147395314|OTHER||mean population value|592.62|||||TWO_SIDED|95.0|533.79|652.72||||||||652.72|533.79|
73932705|NCT02391948|147395315|OTHER||mean population value|3.99|||||TWO_SIDED|95.0|3.91|4.07||||||||4.07|3.91|
73932706|NCT02391948|147395315|OTHER||mean population value|3.49|||||TWO_SIDED|95.0|3.39|3.6||||||||3.60|3.39|
73932707|NCT02391948|147395315|OTHER||mean population value|3.23|||||TWO_SIDED|95.0|3.08|3.37||||||||3.37|3.08|
73932708|NCT02391948|147395315|OTHER||mean population value|2.8|||||TWO_SIDED|95.0|2.67|2.93||||||||2.93|2.67|
73932709|NCT02391948|147395315|OTHER||mean population value|1.79|||||TWO_SIDED|95.0|1.67|1.91||||||||1.91|1.67|
73932710|NCT02391948|147395316|OTHER||mean population value|0.59|||||TWO_SIDED|9.0|0.47|0.72||||||||0.72|0.47|
73864678|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||13.52|TWO_SIDED|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.94|13.52
73864679|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||32.84|TWO_SIDED|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.95|32.84
73864680|NCT02294734|147275792|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||78.09|TWO_SIDED|95.0|0.98|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.98|78.09
73864681|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||60.07|TWO_SIDED|95.0|0.66|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.66|60.07
73864682|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||51.75|TWO_SIDED|95.0|0.65|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.53|0.65|51.75
73864683|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||65.66|TWO_SIDED|95.0|0.6|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.40|0.60|65.66
73864684|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||81.67|TWO_SIDED|95.0|0.59|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.59|81.67
73864685|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.77||||89.98|TWO_SIDED|95.0|0.51|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.51|89.98
73864686|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||43.88|TWO_SIDED|95.0|0.7|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.70|43.88
73932711|NCT02391948|147395316|OTHER||mean population value|1.1|||||TWO_SIDED|95.0|0.91|1.3||||||||1.30|0.91|
73932712|NCT02391948|147395316|OTHER||mean population value|0.68|||||TWO_SIDED|95.0|0.48|0.89||||||||0.89|0.48|
73932713|NCT02391948|147395316|OTHER||mean population value|1.38|||||TWO_SIDED|95.0|1.12|1.65||||||||1.65|1.12|
73932714|NCT02391948|147395316|OTHER||mean population value|2.33|||||TWO_SIDED|95.0|2.08|2.6||||||||2.60|2.08|
73932715|NCT02391948|147395317|OTHER||mean population value age 12|70.6|||||TWO_SIDED|95.0|69.1|72.0||||||||72.0|69.1|
73932716|NCT02391948|147395317|OTHER||mean population value age 12|62.1|||||TWO_SIDED|95.0|59.4|65.0||||||||65.0|59.4|
73932717|NCT02391948|147395317|OTHER||mean population value age 12|62.9|||||TWO_SIDED|95.0|60.9|65.0||||||||65.0|60.9|
74030275|NCT02759146|147614728|SUPERIORITY||Difference between least squared means|0.25||||0.57|TWO_SIDED|95.0|-0.63|1.14|||Mixed Models Analysis||After the initial 4 weeks of reflexology, comparing continued reflexology to added meditative practice|Aim 2: After 4 weeks of reflexology, comparing continuing reflexology vs adding meditative practice||1.14|-.63|0.57
73932718|NCT02391948|147395317|OTHER||mean population value age 12|58.2|||||TWO_SIDED|95.0|56.7|59.7||||||||59.7|56.7|
73932719|NCT02391948|147395317|OTHER||mean population value age 12|51.9|||||TWO_SIDED|95.0|50.2|53.6||||||||53.6|50.2|
73932720|NCT02391948|147395318|OTHER||mean population value age 12|78.3|||||TWO_SIDED|95.0|76.0|80.4||||||||80.4|76.0|
73932721|NCT02391948|147395318|OTHER||mean population value age 12|66.1|||||TWO_SIDED|95.0|63.5|68.5||||||||68.5|63.5|
73932722|NCT02391948|147395318|OTHER||mean population value age 12|60.5|||||TWO_SIDED|95.0|57.3|63.3|||mean population value age 12|||||63.3|57.3|
73932723|NCT02391948|147395318|OTHER||mean population value age 12|37.9|||||TWO_SIDED|95.0|35.6|40.3||||||||40.3|35.6|
73864687|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||36.1|TWO_SIDED|95.0|0.64|1.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.91|0.64|36.10
73864688|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||95.74|TWO_SIDED|95.0|0.47|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.47|95.74
73864689|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.74|TWO_SIDED|95.0|0.67|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|0.67|50.74
73864690|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||72.81|TWO_SIDED|95.0|0.51|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.51|72.81
73864691|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.73||||94.41|TWO_SIDED|95.0|0.5|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.50|94.41
73864692|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.83||||81.07|TWO_SIDED|95.0|0.55|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.55|81.07
73864693|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||69.29|TWO_SIDED|95.0|0.5|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.50|69.29
73932724|NCT02391948|147395318|OTHER||mean population value age 12|14.5|||||TWO_SIDED|95.0|12.4|16.5||||||||16.5|12.4|
73932725|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.06|2.02|||||Data from all GMFCS levels was used, country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in family-centredness outcome.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor family-centred service.||2.02|1.06|
73932726|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|1.07|2.03|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor parents' perception of needs being met.||2.03|1.07|
74008259|NCT03627767|147566491|SUPERIORITY||LSM difference|0.0|||=|0.9294|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.2|= 0.9294
74008260|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.1|||=|0.4081|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.3|= 0.4081
73864694|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||73.67|TWO_SIDED|95.0|0.54|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.37|0.54|73.67
73864695|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||75.82|TWO_SIDED|95.0|0.59|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.59|75.82
73864696|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||54.22|TWO_SIDED|95.0|0.69|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.69|54.22
73864697|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||66.46|TWO_SIDED|95.0|0.63|1.35||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.35|0.63|66.46
73864698|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.16||||21.45|TWO_SIDED|95.0|0.79|1.71||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; D12D28 . The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.71|0.79|21.45
73864699|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||69.91|TWO_SIDED|95.0|0.5|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.50|0.50|69.91
73864700|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||75.29|TWO_SIDED|95.0|0.57|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.57|75.29
73864701|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||44.05|TWO_SIDED|95.0|0.68|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.58|0.68|44.05
73864702|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||94.93|TWO_SIDED|95.0|0.65|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.65|94.93
73932727|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.96|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in the amount of focus on environment.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.38|0.96|
73932728|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|1.07|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in focus on participation.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.58|1.07|
74030276|NCT02759146|147614728|SUPERIORITY||Least Square (LS) Mean|0.49||||0.39|TWO_SIDED|95.0|-0.64|1.63|||Mixed Models Analysis||After the initial 4 weeks of meditative practices, comparing continuing meditative practice to adding reflexology|Aim 3: After 4 weeks of meditative practice, comparing continuing with meditative practice vs. adding reflexology for weeks 5-12||1.63|-0.64|0.39
74088754|NCT03465436|147730589|SUPERIORITY||LS Mean|-3.82|||||TWO_SIDED|90.0|-5.38|-2.26|||Mixed Models Analysis|||8 hours postdose||-2.26|-5.38|
73864703|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.77||||97.11|TWO_SIDED|95.0|0.59|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.59|97.11
73932729|NCT02391948|147395319|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of physical therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of physical therapy services.||1.58|0.72|
73957808|NCT00383188|147451053|SUPERIORITY||LSM Difference|0.829|STANDARD_ERROR_OF_MEAN|1.947||0.6707|TWO_SIDED|95.0|-2.998|4.655|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||4.655|-2.998|0.6707
73864704|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||85.41|TWO_SIDED|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.70|85.41
73864705|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||54.73|TWO_SIDED|95.0|0.62|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.53|0.62|54.73
73864706|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||72.31|TWO_SIDED|95.0|0.61|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.30|0.61|72.31
73864707|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.21||||15.05|TWO_SIDED|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.75|0.84|15.05
73864708|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||84.87|TWO_SIDED|95.0|0.68|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.68|84.87
73864709|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||92.24|TWO_SIDED|95.0|0.63|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.63|92.24
73864710|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||63.42|TWO_SIDED|95.0|0.75|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.75|63.42
73864711|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.17||||9.05|TWO_SIDED|95.0|0.93|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.93|9.05
73864712|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||66.4|TWO_SIDED|95.0|0.74|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.74|66.40
73864713|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.78||||97.39|TWO_SIDED|95.0|0.6|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.00|0.60|97.39
73864714|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||16.02|TWO_SIDED|95.0|0.89|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.89|16.02
74088755|NCT03465436|147730589|SUPERIORITY||LS Mean|-2.65|||||TWO_SIDED|90.0|-4.33|-0.97|||Mixed Models Analysis|||12 hours postdose||-0.97|-4.33|
73864715|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||75.69|TWO_SIDED|95.0|0.68|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.68|75.69
74088756|NCT03465436|147730589|SUPERIORITY||LS Mean|0.12|||||TWO_SIDED|90.0|-1.22|1.46|||Mixed Models Analysis|||24 hours postdose||1.46|-1.22|
73864716|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||90.22|TWO_SIDED|95.0|0.69|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.69|90.22
73864717|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.21||||9.64|TWO_SIDED|95.0|0.91|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.62|0.91|9.64
73864718|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||20.44|TWO_SIDED|95.0|0.82|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.82|20.44
73864719|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||55.06|TWO_SIDED|95.0|0.73|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.73|55.06
73864720|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.36||||5.29|TWO_SIDED|95.0|0.94|1.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.97|0.94|5.29
73864721|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.11||||28.82|TWO_SIDED|95.0|0.77|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.77|28.82
73864722|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.81||||93|TWO_SIDED|95.0|0.61|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.61|93.00
73864723|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.42||||1.64|TWO_SIDED|95.0|1.03|1.95||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.95|1.03|1.64
73864724|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.71|TWO_SIDED|95.0|0.72|1.38||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.38|0.72|50.71
73864725|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.68||||99.52|TWO_SIDED|95.0|0.51|0.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.91|0.51|99.52
73932730|NCT02391948|147395319|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.74|1.28|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of occupational therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of occupational therapy.||1.28|0.74|
73932731|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.97|1.6|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of speech and language therapy.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of speech and language therapy.||1.60|0.97|
73957809|NCT00383188|147451053|SUPERIORITY||LSM Difference|0.425|STANDARD_ERROR_OF_MEAN|1.622||0.7935|TWO_SIDED|95.0|-2.764|3.613|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||3.613|-2.764|0.7935
74030277|NCT02759146|147614729|SUPERIORITY||Least Square (LS) Mean|1.94||||0.67|TWO_SIDED|95.0|-10.93|7.04|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs adding meditative practice|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12||7.04|-10.93|0.67
74030278|NCT02759146|147614729|SUPERIORITY||Least Square (LS) Mean|-1.85||||0.66|TWO_SIDED|95.0|-6.59|10.29|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practices, comparing continued meditative practice vs adding reflexology for weeks 5-12||10.29|-6.59|0.66
74030279|NCT02759146|147614730|SUPERIORITY||Difference between least squared means|-0.19||||0.62|TWO_SIDED|95.0|-0.95|0.57|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12||0.57|-0.95|0.62
74030280|NCT02759146|147614730|SUPERIORITY||Least Square (LS) Mean|-0.04||||0.95|TWO_SIDED|95.0|-1.15|1.22|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practice, comparing continuing meditative practice vs adding reflexology for weeks 5-12||1.22|-1.15|0.95
74030281|NCT02759146|147614731|SUPERIORITY||Difference between least squared means|-0.14||||0.77|TWO_SIDED|95.0|-1.04|0.77|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs adding meditative practice for weeks 5-12||0.77|-1.04|0.77
74030282|NCT02759146|147614731|SUPERIORITY||Least Square (LS) Mean|0.22||||0.67|TWO_SIDED|95.0|-1.23|0.8|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12||0.80|-1.23|0.67
74030283|NCT02759146|147614732|SUPERIORITY||Least Square (LS) Mean|0.09||||0.42|TWO_SIDED|95.0|-0.88|0.37|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.37|-0.88|0.42
74030284|NCT02759146|147614732|SUPERIORITY||Least Square (LS) Mean|-0.34||||0.29|TWO_SIDED|95.0|-0.98|0.29|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practices vs control for weeks 5-12||0.29|-0.98|0.29
73864726|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||3.1|TWO_SIDED|95.0|0.99|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.99|3.10
73864727|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||75.39|TWO_SIDED|95.0|0.71|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.71|75.39
73864728|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||93.29|TWO_SIDED|95.0|0.68|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.68|93.29
74030285|NCT02759146|147614733|SUPERIORITY||Least Square (LS) Mean|-0.42||||0.15|TWO_SIDED|95.0|-1.0|0.15|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.15|-1.00|0.15
74030286|NCT02759146|147614733|SUPERIORITY||Least Square (LS) Mean|-0.2||||0.5|TWO_SIDED|95.0|-0.8|0.39|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practice vs control for weeks 5-12||0.39|-0.80|0.50
74030287|NCT02759146|147614734|SUPERIORITY||Least Square (LS) Mean|-0.27||||0.33|TWO_SIDED|95.0|-0.83|0.28|||Mixed Models Analysis||Comparing reflexology vs control for week 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.28|-0.83|0.33
74030288|NCT02759146|147614734|SUPERIORITY||Least Square (LS) Mean|-0.36||||0.22|TWO_SIDED|95.0|-0.93|0.21|||Mixed Models Analysis|||Aim 4: Comparing meditative practice vs control for weeks 5-12||0.21|-0.93|0.22
74030289|NCT02759146|147614735|SUPERIORITY||Least Square (LS) Mean|0.92||||0.17|TWO_SIDED|95.0|-8.62|1.52|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||1.52|-8.62|0.17
74030290|NCT02759146|147614735|SUPERIORITY||Least Square (LS) Mean|-4.48||||0.09|TWO_SIDED|95.0|-9.66|0.7|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practice vs control for weeks 5-12||0.70|-9.66|0.09
74030291|NCT01397071|147614736|OTHER||Mean Difference (Final Values)|2.2||||0.052|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison of change in PAT measurements was made to beef alone vs. beef with avocado 2 hours post-ingestion||||0.052
74030292|NCT01397071|147614737|OTHER||% of baseline|0.58||||0.03|TWO_SIDED|||||Significance is defined as p\<0.05.|t-test, 2 sided|||Comparison was made to beef patty alone vs. beef patty with avocado added 3 hours post-ingestion.||||0.03
74030293|NCT00367640|147614741|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.0006
74088757|NCT03465436|147730589|SUPERIORITY||LS Mean|-3.09|||||TWO_SIDED|90.0|-4.16|-2.02|||Mixed Models Analysis|||30 minutes postdose||-2.02|-4.16|
74088758|NCT03465436|147730589|SUPERIORITY||LS Mean|-5.61|||||TWO_SIDED|90.0|-6.65|-4.58|||Mixed Models Analysis|||1 hour postdose||-4.58|-6.65|
74088759|NCT03465436|147730589|SUPERIORITY||LS Mean|-5.39|||||TWO_SIDED|90.0|-6.42|-4.35|||Mixed Models Analysis|||1.5 hours postdose||-4.35|-6.42|
74030294|NCT00367640|147614741|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.0001
74030295|NCT00367640|147614741|SUPERIORITY_OR_OTHER|||||||0.4606|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.4606
74030296|NCT02214186|147614761|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
74030297|NCT02214186|147614762|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
74030298|NCT02214186|147614763|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|ANOVA for repeated measures||||||<0.05
74030299|NCT02214186|147614764|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
74030300|NCT02214186|147614765|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|ANOVA for repeated measures.||||||>0.05
74030301|NCT02214186|147614766|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
74030302|NCT02214186|147614767|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74030303|NCT02214186|147614768|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|ANOVA for repeated measures.||||||<0.05
74030304|NCT02214186|147614769|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74030305|NCT01525849|147614770|NON_INFERIORITY_OR_EQUIVALENCE|Significance level=0.025 (1-sided alpha), power=90%, delta=0.8, true difference=0, SD for both arms=1.0. A total sample size of 72 participants (36 per arm) was required to test the hypothesis.|||||<|0.001|||||||t-test, 1 sided|||Non-inferiority test to demonstrate that the long-term (1-year) change in sinus symptoms (overall SNOT-20 score) after balloon dilation is not worse than after FESS.||||<0.001
74030306|NCT01525849|147614771|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|||Test for superiority of balloon dilation over FESS. Significance level=0.025 (1-sided alpha), power=90%, BD estimate=0.5, FESS estimate=1.5, SD for both arms=1.0. A total sample size of 46 participants (23 per arm) was required to test the hypothesis.||||<0.0001
74030307|NCT01525849|147614772|SUPERIORITY_OR_OTHER|||||||0.628|||||||t-test, 2 sided|||||||0.628
74030308|NCT01525849|147614774|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74030309|NCT00339183|147614775|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-2.91||||0.0036|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.||||0.0036
74030310|NCT00339183|147614775|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.46||||0.1448|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|PFS in the Mutant Efficacy Analysis Set was compared at a 1% level conditional upon first demonstrating a significant difference in PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.1448
74030311|NCT00339183|147614776|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.57||||0.1154|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.||||0.1154
74030312|NCT00339183|147614776|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-0.6||||0.5503|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|The treatment effect on OS in the Mutant KRAS Efficacy Analysis Set was compared at the 4% level conditional on first demonstrating a significant OS treatment effect in the Wild-type KRAS Efficacy Analysis Set.||||0.5503
74030313|NCT00339183|147614777|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.33|||<|0.0001|TWO_SIDED|95.0|3.21|8.6|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.|||8.60|3.21|<0.0001
74030314|NCT00339183|147614777|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.56|1.76|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.|||1.76|0.56|1.0000
74030315|NCT01455428|147614793|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.188||0.0002|TWO_SIDED|95.0|-1.08|-0.34||Primary analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.34|-1.08|0.0002
74088760|NCT03465436|147730589|SUPERIORITY||LS Mean|-4.64|||||TWO_SIDED|90.0|-5.55|-3.72|||Mixed Models Analysis|||2 hours postdose||-3.72|-5.55|
74088761|NCT03465436|147730589|SUPERIORITY||LS Mean|-5.82|||||TWO_SIDED|90.0|-6.77|-4.87|||Mixed Models Analysis|||2.5 hours postdose||-4.87|-6.77|
74088762|NCT03465436|147730589|SUPERIORITY||LS Mean|-4.99|||||TWO_SIDED|90.0|-6.03|-3.96|||Mixed Models Analysis|||3 hours postdose||-3.96|-6.03|
74088763|NCT03465436|147730589|SUPERIORITY||LS Mean|-3.69|||||TWO_SIDED|90.0|-4.68|-2.71|||Mixed Models Analysis|||3.5 hours postdose||-2.71|-4.68|
74088764|NCT03465436|147730589|SUPERIORITY||LS Mean|-3.19|||||TWO_SIDED|90.0|-4.21|-2.17|||Mixed Models Analysis|||4 hours postdose||-2.17|-4.21|
74088765|NCT03465436|147730589|SUPERIORITY||LS Mean|-6.29|||||TWO_SIDED|90.0|-7.83|-4.95|||Mixed Models Analysis|||6 hours postdose||-4.95|-7.83|
74088766|NCT03465436|147730589|SUPERIORITY||LS Mean|-5.37|||||TWO_SIDED|90.0|-6.73|-4.02|||Mixed Models Analysis|||8 hours postdose||-4.02|-6.73|
73864729|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.33||||3.79|TWO_SIDED|95.0|0.97|1.82||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.82|0.97|3.79
73864730|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||36.75|TWO_SIDED|95.0|0.76|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|0.76|36.75
73864731|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.72||||99.32|TWO_SIDED|95.0|0.56|0.93||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.93|0.56|99.32
73864732|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||18.91|TWO_SIDED|95.0|0.93|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.93|18.91
73864733|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.35|TWO_SIDED|95.0|0.87|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.87|47.35
73864734|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||78|TWO_SIDED|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.86|78.00
73864735|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||2.65|TWO_SIDED|95.0|1.0|1.67||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.67|1.00|2.65
73864736|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||58.48|TWO_SIDED|95.0|0.73|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.73|58.48
73864737|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.75||||99.64|TWO_SIDED|95.0|0.61|0.92||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.92|0.61|99.64
73864738|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||1.9|TWO_SIDED|95.0|1.01|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.40|1.01|1.90
73864739|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||63.03|TWO_SIDED|95.0|0.81|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.81|63.03
74008261|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||||||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.3|
74008262|NCT03627767|147566491|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.4|||Mixed Models Analysis|||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.4|-2.1|< 0.0001
73864740|NCT02294734|147275793|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.83||||99.19|TWO_SIDED|95.0|0.72|0.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.97|0.72|99.19
73864741|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||67.19|TWO_SIDED|95.0|0.64|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.33|0.64|67.19
73864742|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||44.8|TWO_SIDED|95.0|0.66|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.66|44.80
73864743|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||59.9|TWO_SIDED|95.0|0.61|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.61|59.90
73864744|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||70.12|TWO_SIDED|95.0|0.63|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.63|70.12
73864745|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||83.98|TWO_SIDED|95.0|0.54|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.54|83.98
73864746|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||34.93|TWO_SIDED|95.0|0.73|1.57||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.57|0.73|34.93
74030316|NCT01455428|147614794|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.149||0.001|TWO_SIDED|95.0|-0.79|-0.2||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.20|-0.79|0.0010
73864747|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||32.45|TWO_SIDED|95.0|0.65|1.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.96|0.65|32.45
73864748|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||95.35|TWO_SIDED|95.0|0.46|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.46|95.35
73864749|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.1|TWO_SIDED|95.0|0.66|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.54|0.66|50.10
73864750|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||59.37|TWO_SIDED|95.0|0.55|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.55|59.37
74088767|NCT03465436|147730589|SUPERIORITY||LS Mean|-4.71|||||TWO_SIDED|90.0|-6.25|-3.17|||Mixed Models Analysis|||12 hours postdose||-3.17|-6.25|
74088768|NCT03465436|147730589|SUPERIORITY||LS Mean|-0.55|||||TWO_SIDED|90.0|-1.74|0.63|||Mixed Models Analysis|||24 hours postdose||0.63|-1.74|
73864751|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.8||||87.99|TWO_SIDED|95.0|0.55|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.55|87.99
73864752|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||70.87|TWO_SIDED|95.0|0.59|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.36|0.59|70.87
73864753|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||63.71|TWO_SIDED|95.0|0.51|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.51|63.71
73864754|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||65.99|TWO_SIDED|95.0|0.57|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.57|65.99
73864755|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||71.95|TWO_SIDED|95.0|0.6|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.60|71.95
73864756|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||48.28|TWO_SIDED|95.0|0.71|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.71|48.28
73864757|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||61.06|TWO_SIDED|95.0|0.65|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.65|61.06
73864758|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||18.05|TWO_SIDED|95.0|0.82|1.74||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.74|0.82|18.05
73864759|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||61.12|TWO_SIDED|95.0|0.53|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.53|61.12
73957810|NCT00383188|147451053|SUPERIORITY||LSM Difference|2.525|STANDARD_ERROR_OF_MEAN|1.592||0.1135|TWO_SIDED|95.0|-0.605|5.655|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||5.655|-0.605|0.1135
74030317|NCT01455428|147614794|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.94|-0.35||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.35|-0.94|<0.0001
74030318|NCT01455428|147614794|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.151||0.0001|TWO_SIDED|95.0|-0.88|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.29|-0.88|0.0001
74030319|NCT01455428|147614794|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.152||0.0009|TWO_SIDED|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.21|-0.81|0.0009
73864760|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||64.4|TWO_SIDED|95.0|0.61|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|0.61|64.40
73864761|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||38.12|TWO_SIDED|95.0|0.69|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.66|0.69|38.12
73864762|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||91|TWO_SIDED|95.0|0.67|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.67|91.00
73864763|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.81||||94.52|TWO_SIDED|95.0|0.62|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.62|94.52
73864764|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||82.11|TWO_SIDED|95.0|0.72|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.72|82.11
73864765|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||48.1|TWO_SIDED|95.0|0.64|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.64|48.10
73864766|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||65.66|TWO_SIDED|95.0|0.64|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.36|0.64|65.66
73864767|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.25||||11.46|TWO_SIDED|95.0|0.87|1.8||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.80|0.87|11.46
73864768|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||77.2|TWO_SIDED|95.0|0.7|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.70|77.20
73864769|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||87.35|TWO_SIDED|95.0|0.66|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.66|87.35
73864770|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||56.53|TWO_SIDED|95.0|0.77|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.77|56.53
74008263|NCT03627767|147566491|SUPERIORITY||LSM difference|-2.3|||<|0.0001|TWO_SIDED|95.0|-2.7|-2.0|||Mixed Models Analysis|||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.0|-2.7|< 0.0001
74008264|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.6|||||TWO_SIDED|95.0|-0.9|-0.2||||||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-0.9|
73864771|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||7.29|TWO_SIDED|95.0|0.94|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.50|0.94|7.29
73864772|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||55.09|TWO_SIDED|95.0|0.75|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.75|55.09
73864773|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.79||||96.49|TWO_SIDED|95.0|0.61|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.61|96.49
73864774|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||14.54|TWO_SIDED|95.0|0.9|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.90|14.54
73864775|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||66.85|TWO_SIDED|95.0|0.71|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.71|66.85
73864776|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||85.77|TWO_SIDED|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.70|85.77
73864777|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.24||||8.67|TWO_SIDED|95.0|0.91|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|0.91|8.67
73971649|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.257|||<|0.0001|TWO_SIDED|95.0|-41.957|-20.557|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-20.557|-41.957|<.0001
73864778|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||14.8|TWO_SIDED|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.75|0.84|14.80
73864779|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||45.69|TWO_SIDED|95.0|0.75|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.37|0.75|45.69
73864780|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.42||||2.94|TWO_SIDED|95.0|0.99|2.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||2.06|0.99|2.94
74088769|NCT03465436|147730589|SUPERIORITY||LS Mean|1.32|||||TWO_SIDED|90.0|0.32|2.33|||Mixed Models Analysis|||30 minutes postdose||2.33|0.32|
74088770|NCT03465436|147730589|SUPERIORITY||LS Mean|2.29|||||TWO_SIDED|90.0|1.19|3.4|||Mixed Models Analysis|||1 hour postdose||3.40|1.19|
73864781|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||13.92|TWO_SIDED|95.0|0.85|1.73||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.73|0.85|13.92
73864782|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||86.4|TWO_SIDED|95.0|0.65|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.65|86.40
73864783|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.46||||0.88|TWO_SIDED|95.0|1.06|2.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||2.00|1.06|0.88
73864784|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||41.25|TWO_SIDED|95.0|0.75|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.75|41.25
73864785|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||99.2|TWO_SIDED|95.0|0.52|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.94|0.52|99.20
73864786|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||3.49|TWO_SIDED|95.0|0.98|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.98|3.49
73864787|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||73.09|TWO_SIDED|95.0|0.72|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.72|73.09
73864788|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||92.41|TWO_SIDED|95.0|0.69|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.69|92.41
73864789|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.38||||2.29|TWO_SIDED|95.0|1.01|1.89||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.89|1.01|2.29
73864790|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||23.67|TWO_SIDED|95.0|0.81|1.56||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters.Unstructured covariance matrix fitted, accounting for correlation within region and visit|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.56|0.81|23.67
74088771|NCT03465436|147730589|SUPERIORITY||LS Mean|1.3|||||TWO_SIDED|90.0|0.31|2.28|||Mixed Models Analysis|||1.5 hours postdose||2.28|0.31|
73932732|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.0|1.88|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor family-centred service.||1.88|1.00|
73932733|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.78|1.44|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor family-centred service.||1.44|0.78|
74088772|NCT03465436|147730589|SUPERIORITY||LS Mean|1.07|||||TWO_SIDED|90.0|0.17|1.97|||Mixed Models Analysis|||2 hours postdose||1.97|0.17|
74088773|NCT03465436|147730589|SUPERIORITY||LS Mean|0.21|||||TWO_SIDED|90.0|-0.81|1.23|||Mixed Models Analysis|||2.5 hours postdose||1.23|-0.81|
73864791|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.75||||98.87|TWO_SIDED|95.0|0.59|0.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.96|0.59|98.87
73864792|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||14.5|TWO_SIDED|95.0|0.95|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.95|14.50
73864793|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||30.26|TWO_SIDED|95.0|0.91|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.91|30.26
73864794|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||62.84|TWO_SIDED|95.0|0.89|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.89|62.84
73864795|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.31||||2.06|TWO_SIDED|95.0|1.01|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|1.01|2.06
73864796|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||49.97|TWO_SIDED|95.0|0.76|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.76|49.97
73864797|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.76||||99.43|TWO_SIDED|95.0|0.62|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.94|0.62|99.43
73864798|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.2||||1.17|TWO_SIDED|95.0|1.02|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|1.02|1.17
73864799|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||49.78|TWO_SIDED|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.84|49.78
73932734|NCT02391948|147395319|OTHER||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.54|1.26|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor family-centred service.||1.26|0.54|
73932735|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.0|1.87|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor parents' perception of needs being met.||1.87|1.00|
74030320|NCT01455428|147614794|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.153||0.0009|TWO_SIDED|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.21|-0.81|0.0009
74088774|NCT03465436|147730589|SUPERIORITY||LS Mean|0.53|||||TWO_SIDED|90.0|-0.5|1.56|||Mixed Models Analysis|||3 hours postdose||1.56|-0.50|
74088775|NCT03465436|147730589|SUPERIORITY||LS Mean|1.36|||||TWO_SIDED|90.0|0.29|2.44|||Mixed Models Analysis|||3.5 hours postdose||2.44|0.29|
74088776|NCT03465436|147730589|SUPERIORITY||LS Mean|1.21|||||TWO_SIDED|90.0|0.09|2.34|||Mixed Models Analysis|||4 hours postdose||2.34|0.09|
73864800|NCT02294734|147275794|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||98.66|TWO_SIDED|95.0|0.73|0.98||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.98|0.73|98.66
73864801|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||32.51|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|32.51
73864802|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||6.21|TWO_SIDED|95.0|0.99|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.99|6.21
73864803|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||15.91|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|15.91
73864804|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||6.73|TWO_SIDED|95.0|0.99|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.99|6.73
73864805|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||27.65|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|27.65
73864806|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||12.19|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|12.19
73864807|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||11.62|TWO_SIDED|95.0|0.98|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.98|11.62
73864808|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||7.66|TWO_SIDED|95.0|0.99|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.99|7.66
73864809|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.88|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|28.88
73971650|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-29.862|||<|0.0001|TWO_SIDED|95.0|-44.234|-15.491|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.491|-44.234|<.0001
74088777|NCT03465436|147730589|SUPERIORITY||LS Mean|-0.49|||||TWO_SIDED|90.0|-1.97|0.99|||Mixed Models Analysis|||6 hours postdose||0.99|-1.97|
74088778|NCT03465436|147730589|SUPERIORITY||LS Mean|-0.36|||||TWO_SIDED|90.0|-1.54|0.83|||Mixed Models Analysis|||8 hours postdose||0.83|-1.54|
74088779|NCT03465436|147730589|SUPERIORITY||LS Mean|0.73|||||TWO_SIDED|90.0|-0.87|2.34|||Mixed Models Analysis|||12 hours postdose||2.34|-0.87|
73864810|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.28|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|28.28
73864811|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||27.87|TWO_SIDED|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.97|27.87
73864812|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||9.83|TWO_SIDED|95.0|0.99|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC Region; Upper Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.99|9.83
73864813|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||21.87|TWO_SIDED|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.97|21.87
73864814|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||18.58|TWO_SIDED|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.97|18.58
73864815|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||22.28|TWO_SIDED|95.0|0.98|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.98|22.28
73864816|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||10.86|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|10.86
73864817|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||84.89|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|84.89
73864818|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||63.78|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|63.78
73864819|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||69.42|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|69.42
73864820|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||62.63|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|62.63
73932736|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.83|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor parents' perception of needs being met.||1.53|0.83|
74030321|NCT01455428|147614794|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.153||0.0001|TWO_SIDED|95.0|-0.89|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.29|-0.89|0.0001
73864821|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||72.55|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|72.55
73864822|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||36.28|TWO_SIDED|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.97|36.28
73864823|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.44|TWO_SIDED|95.0|0.96|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.96|47.44
73864824|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||22.99|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|22.99
73864825|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||85.95|TWO_SIDED|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.94|85.95
73864826|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||60.2|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|60.20
73864827|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||81.34|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|81.34
73864828|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||63.04|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC UpperDay 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|63.04
73864829|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||69.67|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|69.67
73864830|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||39.81|TWO_SIDED|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.97|39.81
74030322|NCT01455428|147614794|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.01|-0.41||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.41|-1.01|<0.0001
73864831|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||73.01|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|73.01
74088780|NCT03465436|147730589|SUPERIORITY||LS Mean|-0.12|||||TWO_SIDED|90.0|-1.29|1.04|||Mixed Models Analysis|||24 hours postdose||1.04|-1.29|
74091621|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.01|||||TWO_SIDED|95.0|1.03|3.96|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 22F||3.96|1.03|
73864832|NCT02294734|147275795|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.97|TWO_SIDED|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.97|48.97
73864833|NCT02294734|147275796|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||2.89|TWO_SIDED|95.0|1.0|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|1.00|2.89
73864834|NCT02294734|147275796|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||8.49|TWO_SIDED|95.0|0.99|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.99|8.49
73864835|NCT02294734|147275796|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||86.21|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|86.21
73864836|NCT02294734|147275796|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||75.2|TWO_SIDED|95.0|0.98|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.98|75.20
73864837|NCT02294734|147275796|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||84.29|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|84.29
73864838|NCT02294734|147275796|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||71.08|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|71.08
73864839|NCT02294734|147275796|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||34.93|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|34.93
73864840|NCT02294734|147275796|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.05|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|25.05
73864841|NCT02294734|147275797|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.51|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|28.51
73864842|NCT02294734|147275797|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||32.15|TWO_SIDED|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.97|32.15
73864843|NCT02294734|147275797|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||66.51|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|66.51
73932737|NCT02391948|147395319|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.59|1.3|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor parents' perception of needs being met.||1.3|0.59|
73864844|NCT02294734|147275797|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||45.28|TWO_SIDED|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.98|45.28
73864845|NCT02294734|147275805|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.0||||0.487|TWO_SIDED|95.0|-118.5|115.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||115.3|-118.5|0.487
73864846|NCT02294734|147275805|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|60.6||||0.816|TWO_SIDED|95.0|-73.3|194.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||194.3|-73.3|0.816
73864847|NCT02294734|147275808|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.144||||0.151|TWO_SIDED|95.0|-0.42|0.133|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||0.133|-0.420|0.151
74088781|NCT02243293|147730594|NON_INFERIORITY|The non-inferiority of the rate of sustained virologic response at 12 weeks after treatment as compared to historical control (in genotype 2 (GT2) DAA-naive participants in Part 4, arm S) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|98.5|||||TWO_SIDED|95.0|96.5|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|||100.0|96.5|
74088782|NCT03135899|147730609|OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.064|||TWO_SIDED|90.0|-0.048|0.165|||Mixed Models Analysis||BI 443651 100 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.165|-0.048|
73864848|NCT02294734|147275808|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.121||||0.712|TWO_SIDED|95.0|-0.305|0.551|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||0.551|-0.305|0.712
73864849|NCT02294734|147275809|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.18||||0.817|TWO_SIDED|95.0|-0.216|0.57|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||0.570|-0.216|0.817
73864850|NCT02294734|147275809|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.114||||0.697|TWO_SIDED|95.0|-0.324|0.549|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||0.549|-0.324|0.697
73864851|NCT02294734|147275812|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.171||||0.965|TWO_SIDED|95.0|0.988|1.388|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.||||1.388|0.988|0.965
73864852|NCT02294734|147275812|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.114||||0.913|TWO_SIDED|95.0|0.953|1.305|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.||||1.305|0.953|0.913
73932738|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.9|1.29|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.29|0.9|
73932739|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.86|1.22||||||Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.22|0.86|
73864853|NCT03847909|147275861|SUPERIORITY|P value is from an ANCOVA model with treatment group as the main effect, age category, baseline eGFR category, baseline Uox value as covariates for adjustment.|Difference of Least Mean Square|5171.7|STANDARD_ERROR_OF_MEAN|1144.07|<|0.0001|TWO_SIDED|95.0|2929.3|7414.2|||ANCOVA|||||7414.2|2929.3|<0.0001
73864854|NCT00975143|147275898|NON_INFERIORITY_OR_EQUIVALENCE|Pre-defined criterion for non-inferiority: upper bound of the 95% CI for the treatment difference \< 4.|LS Mean Difference|0.1382||||0.5077|TWO_SIDED|95.0|-0.2712|0.5475||P values are from analysis of covariance (ANCOVA) controlling for Baseline total nodular lesion count, gender and analysis site.|ANCOVA|The 95% CI of the adjusted least square mean difference (CIP-ISOTRETINOIN minus Isotretinoin) was calculated using the ANCOVA model.||Change from Baseline was calculated as the post-Baseline value minus the Baseline value||0.5475|-0.2712|0.5077
73864855|NCT00975143|147275899|NON_INFERIORITY_OR_EQUIVALENCE|If the two co-primary endpoints were significant, a 95% 2 sided CI on the difference between treatments (CIP-Isotretinoin minus Isotretinoin) was calculated.|Proportion difference|-3.48|||>|0.05|TWO_SIDED|95.0|-8.4|1.4|||Normal approximation|95% CI on difference in proportions (CIP-Isotretinoin minus Isotretinoin) was estimated using normal approximation.||The analysis of the secondary efficacy endpoint was based on observed cases only, with no imputation for missing values.||1.4|-8.4|>0.05
73864856|NCT00975143|147275900|NON_INFERIORITY_OR_EQUIVALENCE|Pre-defined criterion for non-inferiority: lower bound of the 95% CI for the treatment difference \> -10.|Proportion difference|-2.1|||>|0.05|TWO_SIDED|95.0|-7.94|3.74|||Normal approximation|||||3.74|-7.94|>0.05
73864857|NCT00884832|147275960|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Proportion of semi-formed and loose stools (Bristol Form 5-7) associated with diarrhea subgroup versus no diarrhea subgroup.||||<0.001
73864858|NCT00884832|147275961|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANCOVA|||||||0.018
73864859|NCT00884832|147275961|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|||drug\*group interactions||||0.047
73864860|NCT00884832|147275963|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||ANCOVA|||||||0.082
73864861|NCT02337725|147275964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.39|||<|0.0001|TWO_SIDED|95.0|-8.53|-4.25|||ANCOVA||Estimated Value was reported for the least squares mean difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).|||-4.250|-8.530|<0.0001
73864862|NCT02096263|147275973|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|1.1|||||TWO_SIDED|95.0|0.92|1.31|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertussis toxoid (PT), one month after the third dose of the primary vaccination.||1.31|0.92|
73864863|NCT02096263|147275973|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|1.14|||||TWO_SIDED|95.0|0.97|1.35|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, filamentous hemagglutinin (FHA), one month after the third dose of the primary vaccination.||1.35|0.97|
73971651|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.512|||<|0.0001|TWO_SIDED|95.0|-46.971|-16.053|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-16.053|-46.971|<.0001
73864864|NCT02096263|147275973|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|0.79|||||TWO_SIDED|95.0|0.63|0.99|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Tdap vaccination history of the mother during pregnancy as continuous regressor.).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertactin (PRN), one month after the third dose of the primary vaccination.||0.99|0.63|
74030323|NCT01455428|147614794|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.40|-1.00|<0.0001
74091622|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.44|1.67|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 33F||1.67|0.44|
74091623|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.89|||||TWO_SIDED|95.0|0.97|3.69|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 33F||3.69|0.97|
73864865|NCT03322423|147276016|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.058|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.08|-0.035|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||-0.035|-0.080|
73864866|NCT03322423|147276016|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.076|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.099|-0.054|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||-0.054|-0.099|
73864867|NCT03322423|147276017|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|STANDARD_ERROR_OF_MEAN|0.0147|||TWO_SIDED|95.0|0.112|0.17|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||0.170|0.112|
73864868|NCT03322423|147276017|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|STANDARD_ERROR_OF_MEAN|0.0147|||TWO_SIDED|95.0|0.112|0.17|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||0.170|0.112|
73864869|NCT03322423|147276018|SUPERIORITY|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|45.5|STANDARD_ERROR_OF_MEAN|2.19|||TWO_SIDED|95.0|41.2|49.9|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||49.9|41.2|
73864870|NCT03322423|147276018|SUPERIORITY|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|46.4|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|42.1|50.8|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||50.8|42.1|
73864871|NCT00500760|147276030|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.07|||||TWO_SIDED|95.0|-0.23|0.09|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|||0.09|-0.23|
73864872|NCT00500760|147276031|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.03|||||TWO_SIDED|95.0|-0.18|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 6 months||0.12|-0.18|
73864873|NCT00500760|147276031|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.03|||||TWO_SIDED|95.0|-1.09|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 12 months||0.12|-1.09|
73864874|NCT00500760|147276032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.328||||0.3106|TWO_SIDED|95.0|0.767|2.299|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||2.299|0.767|0.3106
73864875|NCT00500760|147276033|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6069|TWO_SIDED|95.0|0.675|1.961|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||1.961|0.675|0.6069
74030324|NCT01455428|147614796|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.2||0.0079|TWO_SIDED|95.0|-0.93|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.14|-0.93|0.0079
73864876|NCT00500760|147276034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.628||||0.1223|TWO_SIDED|95.0|0.877|3.019|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||3.019|0.877|0.1223
73864877|NCT00500760|147276035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.535||||0.1737|TWO_SIDED|95.0|0.217|1.262|||Regression, Logistic||The odds ratio is defined as the odds of having an overall response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.|||1.262|0.217|0.1737
73864878|NCT00500760|147276035|SUPERIORITY_OR_OTHER||Difference in rate|-10.99|||||TWO_SIDED|95.0|-24.56|4.14|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.|||4.14|-24.56|
74030325|NCT01455428|147614797|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.172||0.0024|TWO_SIDED|95.0|-0.86|-0.19||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.19|-0.86|0.0024
73864879|NCT00500760|147276036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.087||||1|TWO_SIDED|95.0|0.448|2.712|||Regression, Logistic||The odds ratio is defined as the odds of having a complete response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.|||2.712|0.448|1.0000
73864880|NCT00500760|147276036|SUPERIORITY_OR_OTHER||Difference in rate|1.33|||||TWO_SIDED|95.0|-13.23|14.71|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.|||14.71|-13.23|
73864881|NCT02641067|147276041|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|90.0|1.0|2.04||||||||2.04|1.00|
73864882|NCT02641067|147276042|OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|0.99|1.92||||||||1.92|0.99|
73864883|NCT02641067|147276043|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.61|1.15||||||||1.15|0.61|
73864884|NCT02925728|147276049|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73864885|NCT04033068|147276054|SUPERIORITY||||||=|0.2003|||||||Fisher-Freeman-Halton Test|||||||= 0.2003
73864886|NCT04033068|147276055|SUPERIORITY||||||=|0.1448|||||||Fisher-Freeman-Halton Test|||||||= 0.1448
73864887|NCT04033068|147276056|SUPERIORITY||||||=|0.9111|||||||Fisher-Freeman-Halton Test|||||||= 0.9111
74091624|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.46|1.08|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 8||1.08|0.46|
73864888|NCT04033068|147276057|SUPERIORITY||||||=|1|||||||Fisher-Freeman-Halton Test|||||||= 1.0000
73864889|NCT04033068|147276059|SUPERIORITY||GMT Ratio|0.9|||=|0.999|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 0||5.5|0.2|= 0.9990
73864890|NCT04033068|147276059|SUPERIORITY||GMT Ratio|0.8|||=|0.9798|TWO_SIDED|95.0|0.1|5.2|||ANOVA|||Day 0||5.2|0.1|= 0.9798
73864891|NCT04033068|147276059|SUPERIORITY||GMT Ratio|1.2|||=|0.9958|TWO_SIDED|95.0|0.1|10.1|||ANOVA|||Day 0||10.1|0.1|= 0.9958
73864892|NCT04033068|147276059|SUPERIORITY||GMT Ratio|0.8|||=|0.9935|TWO_SIDED|95.0|0.1|5.5|||ANOVA|||Day 0||5.5|0.1|= 0.9935
73864893|NCT04033068|147276059|SUPERIORITY||GMT Ratio|1.3|||=|0.9852|TWO_SIDED|95.0|0.2|10.7|||ANOVA|||Day 0||10.7|0.2|= 0.9852
73864894|NCT04033068|147276059|SUPERIORITY||GMT Ratio|1.6|||=|0.944|TWO_SIDED|95.0|0.2|14.4|||ANOVA|||Day 0||14.4|0.2|= 0.9440
73864895|NCT04033068|147276059|SUPERIORITY||GMT Ratio|1.2|||=|0.9943|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 28||5.5|0.2|= 0.9943
73864896|NCT04033068|147276059|SUPERIORITY||GMT Ratio|1.0|||=|0.9999|TWO_SIDED|95.0|0.2|5.1|||ANOVA|||Day 28||5.1|0.2|= 0.9999
73864897|NCT04033068|147276059|SUPERIORITY||GMT Ratio|2.2|||=|0.6476|TWO_SIDED|95.0|0.4|14.3|||ANOVA|||Day 28||14.3|0.4|= 0.6476
73864898|NCT04033068|147276059|SUPERIORITY||GMT Ratio|0.8|||=|0.9911|TWO_SIDED|95.0|0.2|4.3|||ANOVA|||Day 28||4.3|0.2|= 0.9911
73864899|NCT04033068|147276059|SUPERIORITY||GMT Ratio|1.9|||=|0.7647|TWO_SIDED|95.0|0.3|12.0|||ANOVA|||Day 28||12.0|0.3|= 0.7647
73864900|NCT04033068|147276059|SUPERIORITY||GMT Ratio|2.3|||=|0.6447|TWO_SIDED|95.0|0.3|15.8|||ANOVA|||Day 28||15.8|0.3|= 0.6447
73864901|NCT04033068|147276059|SUPERIORITY||GMT Ratio|1.3|||=|0.9638|TWO_SIDED|95.0|0.3|5.3|||ANOVA|||Day 56||5.3|0.3|= 0.9638
73864902|NCT04033068|147276059|SUPERIORITY||GMT Ratio|1.7|||=|0.7837|TWO_SIDED|95.0|0.4|7.7|||ANOVA|||Day 56||7.7|0.4|= 0.7837
73864903|NCT04033068|147276059|SUPERIORITY||GMT Ratio|2.9|||=|0.3427|TWO_SIDED|95.0|0.5|15.3|||ANOVA|||Day 56||15.3|0.5|= 0.3427
73864904|NCT04033068|147276059|SUPERIORITY||GMT Ratio|1.3|||=|0.9578|TWO_SIDED|95.0|0.3|5.8|||ANOVA|||Day 56||5.8|0.3|= 0.9578
73864905|NCT04033068|147276059|SUPERIORITY||GMT Ratio|2.2|||=|0.5637|TWO_SIDED|95.0|0.4|11.7|||ANOVA|||Day 56||11.7|0.4|= 0.5637
73864906|NCT04033068|147276059|SUPERIORITY||GMT Ratio|1.7|||=|0.8471|TWO_SIDED|95.0|0.3|9.6|||ANOVA|||Day 56||9.6|0.3|= 0.8471
73864907|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.95|||||TWO_SIDED|95.0|21.76|41.25|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||41.25|21.76|
73864908|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.86|||||TWO_SIDED|95.0|21.66|41.17|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||41.17|21.66|
73864909|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.91|||||TWO_SIDED|95.0|21.89|41.12|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||41.12|21.89|
73864910|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Difference in percentages|0.09|||||TWO_SIDED|95.0|-3.15|3.36|||Miettinen & Nurminen score method|||Serogroup A- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||3.36|-3.15|
73932740|NCT02391948|147395319|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.7|1.13|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.13|0.7|
73864911|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|38.5|||||TWO_SIDED|95.0|28.54|48.9|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||48.90|28.54|
73864912|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|39.08|||||TWO_SIDED|95.0|29.16|49.46|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||49.46|29.16|
73932741|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.9|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.31|0.9|
74030326|NCT01455428|147614797|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.173||0.0002|TWO_SIDED|95.0|-0.99|-0.31||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.31|-0.99|0.0002
73864913|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|38.79|||||TWO_SIDED|95.0|29.03|49.06|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||49.06|29.03|
73864914|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|-0.59|||||TWO_SIDED|95.0|-4.12|2.92|||Miettinen & Nurminen score method|||Serogroup C-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||2.92|-4.12|
73864915|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|59.98|||||TWO_SIDED|95.0|49.49|69.32|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||69.32|49.49|
73932742|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.91|1.32|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.32|0.91|
74091625|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.58|1.38|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 8||1.38|0.58|
73864916|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|57.37|||||TWO_SIDED|95.0|46.71|66.88|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||66.88|46.71|
73864917|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|58.69|||||TWO_SIDED|95.0|48.32|67.94|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||67.94|48.32|
73864918|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|2.61|||||TWO_SIDED|95.0|-1.17|6.62|||Miettinen & Nurminen score method|||Serogroup W-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||6.62|-1.17|
73864919|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|45.25|||||TWO_SIDED|95.0|35.11|55.47|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||55.47|35.11|
73864920|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|42.67|||||TWO_SIDED|95.0|32.34|53.04|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||53.04|32.34|
73864921|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|43.98|||||TWO_SIDED|95.0|33.92|54.14|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||54.14|33.92|
73864922|NCT02986854|147276093|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|2.58|||||TWO_SIDED|95.0|-0.86|6.3|||Miettinen & Nurminen score method|||Serogroup Y- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||6.3|-0.86|
73864923|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.16|||||TWO_SIDED|95.0|1.23|13.41|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||13.41|1.23|
73864924|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|10.59|||||TWO_SIDED|95.0|3.54|16.14|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||16.14|3.54|
73864925|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|9.36|||||TWO_SIDED|95.0|2.72|13.58|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menactra-Menveo vs. Naive)||13.58|2.72|
73864926|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|-2.44|||||TWO_SIDED|95.0|-8.17|3.24|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||3.24|-8.17|
73864927|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.94|||||TWO_SIDED|95.0|-3.57|14.15|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||14.15|-3.57|
73864928|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.88|||||TWO_SIDED|95.0|-1.77|16.52|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||16.52|-1.77|
73864929|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.89|||||TWO_SIDED|95.0|-2.34|13.48|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||13.48|-2.34|
73864930|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.93|||||TWO_SIDED|95.0|-9.84|5.82|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||5.82|-9.84|
73864931|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|44.33|||||TWO_SIDED|95.0|30.25|54.6|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.60|30.25|
73864932|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|38.05|||||TWO_SIDED|95.0|23.93|48.58|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||48.58|23.93|
73864933|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.26|||||TWO_SIDED|95.0|28.15|49.72|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||49.72|28.15|
73864934|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.28|||||TWO_SIDED|95.0|-5.31|17.71|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||17.71|-5.31|
73864935|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.65|||||TWO_SIDED|95.0|19.25|37.65|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||37.65|19.25|
73864936|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.97|||||TWO_SIDED|95.0|19.6|37.95|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||37.95|19.60|
73864937|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.81|||||TWO_SIDED|95.0|19.5|37.76|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||37.76|19.50|
74091626|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.62|2.15|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 9N||2.15|0.62|
73864938|NCT02986854|147276099|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.32|||||TWO_SIDED|95.0|-2.56|1.86|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.86|-2.56|
73864939|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.78|||||TWO_SIDED|95.0|16.23|38.27|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||38.27|16.23|
73864940|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.4|||||TWO_SIDED|95.0|8.78|31.03|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||31.03|8.78|
73864941|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|24.14|||||TWO_SIDED|95.0|13.28|33.86|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.86|13.28|
73864942|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.37|||||TWO_SIDED|95.0|-0.76|15.42|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||15.42|-0.76|
73864943|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.08|||||TWO_SIDED|95.0|11.04|42.14|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||42.14|11.04|
73864944|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|16.39|||||TWO_SIDED|95.0|0.04|31.9|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||31.90|0.04|
74030327|NCT01455428|147614797|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.173||0.0012|TWO_SIDED|95.0|-0.91|-0.22||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.22|-0.91|0.0012
74030328|NCT01455428|147614797|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.174||0.0101|TWO_SIDED|95.0|-0.79|-0.11||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.11|-0.79|0.0101
73864945|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.85|||||TWO_SIDED|95.0|6.73|36.11|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||36.11|6.73|
73864946|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|10.69|||||TWO_SIDED|95.0|-0.42|21.6|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||21.60|-0.42|
73864947|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|44.4|||||TWO_SIDED|95.0|28.65|58.93|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||58.93|28.65|
73864948|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.9|||||TWO_SIDED|95.0|33.45|63.13|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||63.13|33.45|
73864949|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|46.61|||||TWO_SIDED|95.0|31.52|60.59|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||60.59|31.52|
73864950|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-4.5|||||TWO_SIDED|95.0|-11.84|2.69|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||2.69|-11.84|
73864951|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.9|||||TWO_SIDED|95.0|7.53|21.22|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||21.22|7.53|
73864952|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.55|||||TWO_SIDED|95.0|7.1|20.89|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||20.89|7.10|
73932743|NCT02391948|147395319|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.76|1.24|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.24|0.76|
73864953|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.73|||||TWO_SIDED|95.0|7.34|21.05|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||21.05|7.34|
73864954|NCT02986854|147276100|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.36|||||TWO_SIDED|95.0|-0.96|1.99|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.99|-0.96|
73864955|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.14|||||TWO_SIDED|95.0|3.46|25.39|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||25.39|3.46|
73864956|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.66|||||TWO_SIDED|95.0|5.0|26.89|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||26.89|5.00|
73864957|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.89|||||TWO_SIDED|95.0|4.91|25.62|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||25.62|4.91|
73864958|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.52|||||TWO_SIDED|95.0|-8.51|5.5|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||5.50|-8.51|
73864959|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.44|||||TWO_SIDED|95.0|5.25|34.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||34.83|5.25|
73932744|NCT02391948|147395319|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of physical therapy services.||1.15|.7|
73932745|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.74|1.48|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of physical therapy services.||1.48|.74|
73932746|NCT02391948|147395319|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life -Self Care outcome for the predictor amount of occupational therapy.||1.21|.72|
74008265|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.7|||=|0.0035|TWO_SIDED|95.0|-1.2|-0.2|||Mixed Models Analysis|||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.2|= 0.0035
74091627|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.58|2.04|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 9N||2.04|0.58|
73864960|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.11|||||TWO_SIDED|95.0|5.88|35.5|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||35.50|5.88|
73864961|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.77|||||TWO_SIDED|95.0|6.53|34.58|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||34.58|6.53|
73864962|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.66|||||TWO_SIDED|95.0|-9.67|8.4|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||8.40|-9.67|
73864963|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.2|||||TWO_SIDED|95.0|16.78|45.45|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||45.45|16.78|
73864964|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.22|||||TWO_SIDED|95.0|21.29|49.2|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||49.20|21.29|
74008266|NCT03627767|147566491|SUPERIORITY||LSM difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Models Analysis|||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-1.6|< 0.0001
73864965|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|32.17|||||TWO_SIDED|95.0|19.3|47.13|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||47.13|19.30|
73864966|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-4.02|||||TWO_SIDED|95.0|-9.45|0.74|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||0.74|-9.45|
73864967|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.95|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||23.95|9.28|
73864968|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.95|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||23.95|9.28|
73864969|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.94|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||23.94|9.28|
73864970|NCT02986854|147276101|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.0|||||TWO_SIDED|95.0|-1.31|1.35|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.35|-1.31|
73864971|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.75|||||TWO_SIDED|95.0|10.19|32.25|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||32.25|10.19|
73932747|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.89|1.5|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of occupational therapy.||1.5|.89|
74008267|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.5|||||TWO_SIDED|95.0|-0.8|-0.1||||||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-0.8|
73932748|NCT02391948|147395319|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.65|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of occupational therapy.||1.38|.65|
73932749|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.81|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of speech and language therapy.||1.31|.81|
74008268|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.7|||=|0.0136|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Models Analysis|||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.2|= 0.0136
74039400|NCT04847141|147632409|SUPERIORITY||Difference in Percentage|-2.0||||0.7316|TWO_SIDED|95.0|-13.3|9.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 14||9.4|-13.3|0.7316
73864972|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.72|||||TWO_SIDED|95.0|3.15|25.29|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||25.29|3.15|
73864973|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.27|||||TWO_SIDED|95.0|7.44|27.92|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||27.92|7.44|
73864974|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.03|||||TWO_SIDED|95.0|-1.2|15.17|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||15.17|-1.20|
73864975|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.91|||||TWO_SIDED|95.0|5.57|36.37|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||36.37|5.57|
73864976|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.46|||||TWO_SIDED|95.0|6.05|37.0|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||37.00|6.05|
73864977|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.18|||||TWO_SIDED|95.0|6.89|35.38|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||35.38|6.89|
73864978|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.55|||||TWO_SIDED|95.0|-12.11|11.03|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||11.03|-12.11|
73864979|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|40.06|||||TWO_SIDED|95.0|24.26|54.95|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.95|24.26|
73864980|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|42.4|||||TWO_SIDED|95.0|26.71|57.17|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||57.17|26.71|
73864981|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.21|||||TWO_SIDED|95.0|26.12|55.55|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||55.55|26.12|
73864982|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-2.34|||||TWO_SIDED|95.0|-10.41|5.73|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||5.73|-10.41|
73864983|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.58|||||TWO_SIDED|95.0|15.26|32.08|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||32.08|15.26|
73864984|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.22|||||TWO_SIDED|95.0|14.86|31.74|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||31.74|14.86|
74030329|NCT01455428|147614797|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.0258|TWO_SIDED|95.0|-0.73|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.73|0.0258
73864985|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.41|||||TWO_SIDED|95.0|15.08|31.9|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||31.90|15.08|
73864986|NCT02986854|147276102|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.36|||||TWO_SIDED|95.0|-0.96|1.99|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.99|-0.96|
73864987|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.23|||||TWO_SIDED|95.0|2.08|11.23|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||11.23|2.08|
73864988|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.5|||||TWO_SIDED|95.0|3.28|12.74|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||12.74|3.28|
73864989|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.86|||||TWO_SIDED|95.0|2.87|10.78|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||10.78|2.87|
73864990|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.27|||||TWO_SIDED|95.0|-6.1|3.49|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||3.49|-6.10|
73932750|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.87|1.39|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of speech and language therapy.||1.39|.87|
73932751|NCT02391948|147395319|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.6|1.25|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of speech and language therapy.||1.25|.6|
73932752|NCT02391948|147395319|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.92|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of physical therapy services.||1.53|.92|
73971652|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-37.197|||<|0.0001|TWO_SIDED|95.0|-47.522|-26.872|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-26.872|-47.522|<.0001
73971653|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.442|||<|0.0001|TWO_SIDED|95.0|-44.96|-17.923|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-17.923|-44.960|<.0001
73971654|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-28.597||||0.0002|TWO_SIDED|95.0|-43.34|-13.853|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-13.853|-43.340|0.0002
73971655|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-30.054|||<|0.0001|TWO_SIDED|95.0|-40.943|-19.166|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-19.166|-40.943|<.0001
73864991|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.25|||||TWO_SIDED|95.0|-3.04|12.44|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||12.44|-3.04|
73864992|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.61|||||TWO_SIDED|95.0|-2.71|13.01|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||13.01|-2.71|
73864993|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.43|||||TWO_SIDED|95.0|-2.66|10.9|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||10.90|-2.66|
73864994|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.36|||||TWO_SIDED|95.0|-7.27|6.43|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||6.43|-7.27|
73864995|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.34|||||TWO_SIDED|95.0|28.85|50.63|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||50.63|28.85|
73864996|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|36.88|||||TWO_SIDED|95.0|24.39|46.34|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||46.34|24.39|
73864997|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|39.16|||||TWO_SIDED|95.0|27.61|46.33|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||46.33|27.61|
73864998|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|4.46|||||TWO_SIDED|95.0|-7.04|15.83|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||15.83|-7.04|
73864999|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|31.61|||||TWO_SIDED|95.0|22.68|41.79|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||41.79|22.68|
74030330|NCT01455428|147614797|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.026|TWO_SIDED|95.0|-0.74|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.74|0.0260
74030331|NCT01455428|147614797|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.175||0.0062|TWO_SIDED|95.0|-0.83|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.14|-0.83|0.0062
74030332|NCT01455428|147614797|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.176||0.0081|TWO_SIDED|95.0|-0.81|-0.12||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.12|-0.81|0.0081
73865000|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.85|||||TWO_SIDED|95.0|21.85|41.08|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||41.08|21.85|
73865001|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|31.24|||||TWO_SIDED|95.0|22.39|41.38|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||41.38|22.39|
73932753|NCT02391948|147395323|OTHER||population average|2319.0|||||TWO_SIDED|95.0|1460.0|3218.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3218|1460|
73932754|NCT02391948|147395323|OTHER||population average|1858.0|||||TWO_SIDED|95.0|1233.0|2530.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||2530|1233|
73932755|NCT02391948|147395324|OTHER||population average|5240.0|||||TWO_SIDED|95.0|3874.0|6670.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||6670|3874|
73932756|NCT02391948|147395324|OTHER||population average|4319.0|||||TWO_SIDED|95.0|3258.0|5443.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||5443|3258|
73932757|NCT02391948|147395325|OTHER||population average|108.0|||||TWO_SIDED|95.0|67.0|151.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||151|67|
73932758|NCT02391948|147395325|OTHER||population average|100.0|||||TWO_SIDED|95.0|58.0|145.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||145|58|
73932759|NCT02391948|147395325|OTHER||population average|10.0|||||TWO_SIDED|95.0|0.0|35.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.||35|0|
73932760|NCT02391948|147395326|OTHER||population average|2815.0|||||TWO_SIDED|95.0|2025.0|3650.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3650|2025|
73932761|NCT02391948|147395326|OTHER||population average|3109.0|||||TWO_SIDED|95.0|2502.0|3739.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3739|2502|
73932762|NCT02391948|147395326|OTHER||population average|1056.0|||||TWO_SIDED|95.0|471.0|1665.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.||1665|471|
73932763|NCT01639001|147395330|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.402|||<|0.0001|TWO_SIDED|95.0|0.286|0.565||The study was to be considered positive if the 1-sided log-rank test for PFS, stratified for baseline stratification factors (ECOG PS, ethnicity, and brain metastases) was significant at the 0.02496level.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.|The study was designed to test the null hypothesis H0: λ=1.0 versus the alternative hypothesis HA: λ \< 1.0, where λ is the hazard ratio (HR; Crizotinib/Chemotherapy). Evaluation of 160 PFS events in the 2 arms using a 1-sided log-rank test at the 0.025 level of significance was required to detect a HR of 0.64 with 80% power.||0.565|0.286|<0.0001
74030333|NCT01455428|147614798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||||||Analysis was two-sided and performed at the 0.05 significance level|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.||||0.0007
74030334|NCT01455428|147614801|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.18|STANDARD_ERROR_OF_MEAN|1.932|<|0.0001|TWO_SIDED|95.0|-11.99|-4.37||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-4.37|-11.99|<0.0001
73865002|NCT02986854|147276103|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.76|||||TWO_SIDED|95.0|-1.81|3.52|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||3.52|-1.81|
73865003|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.02|||||TWO_SIDED|95.0|19.55|38.83|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||38.83|19.55|
73865004|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.87|||||TWO_SIDED|95.0|10.48|29.69|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||29.69|10.48|
73971656|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-5.904||||0.2667|TWO_SIDED|95.0|-16.37|4.563|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.563|-16.370|0.2667
73971657|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|8.767||||0.2085|TWO_SIDED|95.0|-4.95|22.485|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||22.485|-4.950|0.2085
74008269|NCT03627767|147566491|SUPERIORITY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.6|< 0.0001
74008270|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.4|||||TWO_SIDED|95.0|-0.8|0.0||||||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.0|-0.8|
74030335|NCT01455428|147614802|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.107||0.0007|TWO_SIDED|95.0|-0.58|-0.16||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.16|-0.58|0.0007
74030336|NCT01455428|147614804|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|2.464||0.0039|TWO_SIDED|95.0|-12.08|-2.35||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-2.35|-12.08|0.0039
74030337|NCT01455428|147614805|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.783||0.5351|TWO_SIDED|95.0|-3.76|7.22||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||7.22|-3.76|0.5351
74030338|NCT01455428|147614806|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|2.579||0.8892|TWO_SIDED|95.0|-5.45|4.73||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||4.73|-5.45|0.8892
74088783|NCT03135899|147730609|OTHER||Mean Difference (Final Values)|-0.037|STANDARD_ERROR_OF_MEAN|0.064|||TWO_SIDED|90.0|-0.144|0.07|||Mixed Models Analysis||BI 443651 400 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.070|-0.144|
73865005|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|25.5|||||TWO_SIDED|95.0|15.79|33.21|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.21|15.79|
73865006|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|9.14|||||TWO_SIDED|95.0|1.01|17.16|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||17.16|1.01|
74030339|NCT01455428|147614807|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.147||0.0035|TWO_SIDED|95.0|0.14|0.72||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||0.72|0.14|0.0035
73865007|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|25.0|||||TWO_SIDED|95.0|8.82|38.9|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||38.90|8.82|
73865008|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.76|||||TWO_SIDED|95.0|-0.44|29.86|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||29.86|-0.44|
73865009|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.48|||||TWO_SIDED|95.0|5.32|33.08|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.08|5.32|
73865010|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|9.24|||||TWO_SIDED|95.0|-2.45|20.68|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||20.68|-2.45|
73865011|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|50.25|||||TWO_SIDED|95.0|34.09|63.67|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||63.67|34.09|
73865012|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|49.48|||||TWO_SIDED|95.0|33.21|63.01|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||63.01|33.21|
73865013|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|49.87|||||TWO_SIDED|95.0|34.42|62.6|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||62.60|34.42|
73865014|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.77|||||TWO_SIDED|95.0|-8.3|9.92|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||9.92|-8.30|
73865015|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.76|||||TWO_SIDED|95.0|21.34|39.75|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||39.75|21.34|
73865016|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.75|||||TWO_SIDED|95.0|21.32|39.74|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||39.74|21.32|
73865017|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.76|||||TWO_SIDED|95.0|21.35|39.73|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||39.73|21.35|
73865018|NCT02986854|147276104|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.01|||||TWO_SIDED|95.0|-1.6|1.67|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.67|-1.60|
73865019|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.36|||||TWO_SIDED|95.0|5.85|28.67|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||28.67|5.85|
73932764|NCT01639001|147395331|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|41.869|||<|0.0001|TWO_SIDED|95.0|30.34|53.398||If the PFS endpoint was significant, ORR was to be considered significant if 2-sided p-value from Pearson chi-square test was \<= 0.04992.|2-sided pearson chi-square test||Treatment difference in ORR (%)|The confidence interval for the treatment difference was based on normal distribution.||53.398|30.340|<0.0001
73865020|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.92|||||TWO_SIDED|95.0|6.39|29.25|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||29.25|6.39|
73865021|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.64|||||TWO_SIDED|95.0|6.85|28.28|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||28.28|6.85|
73865022|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.57|||||TWO_SIDED|95.0|-8.32|7.2|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||7.20|-8.32|
73957811|NCT00383188|147451053|SUPERIORITY||LSM Difference|2.63|STANDARD_ERROR_OF_MEAN|1.912||0.1697|TWO_SIDED|95.0|-1.128|6.388|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||6.388|-1.128|0.1697
73865023|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.58|||||TWO_SIDED|95.0|-0.98|30.38|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||30.38|-0.98|
73865024|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.64|||||TWO_SIDED|95.0|7.3|38.16|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||38.16|7.30|
73865025|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.53|||||TWO_SIDED|95.0|4.14|33.37|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.37|4.14|
73971658|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|12.455||||0.1041|TWO_SIDED|95.0|-2.595|27.505|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||27.505|-2.595|0.1041
73971659|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-25.353||||0.0058|TWO_SIDED|95.0|-45.41|-5.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-5.295|-45.410|0.0058
73971660|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-38.63||||0.001|TWO_SIDED|95.0|-65.062|-12.197|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-12.197|-65.062|0.0010
73971661|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-43.967||||0.0005|TWO_SIDED|95.0|-72.443|-15.491|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.491|-72.443|0.0005
73971662|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.293||||0.0003|TWO_SIDED|95.0|-51.159|-11.428|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-11.428|-51.159|0.0003
74030340|NCT01455428|147614808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.0972|TWO_SIDED|95.0|0.9|3.6||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.||3.60|0.90|0.0972
73865026|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-8.06|||||TWO_SIDED|95.0|-18.34|2.38|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||2.38|-18.34|
73865027|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|39.04|||||TWO_SIDED|95.0|23.76|54.07|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.07|23.76|
73932765|NCT01639001|147395332|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.056||||0.6172|TWO_SIDED|95.0|0.734|1.521||If the PFS and ORR endpoints were significant, OS was to be considered significant if 1-sided, log-rank test stratified for ECOG, ethnicity and metastases was \<= 0.02496.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.|||1.521|0.734|0.6172
73932766|NCT01639001|147395333|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|8.906||||0.1204|TWO_SIDED|95.0|-2.275|20.086|||2-sided pearson chi-square test||Treatment Difference in DCR Rate (%)|The confidence interval for the treatment difference was based on normal distribution.||20.086|-2.275|0.1204
73932767|NCT01639001|147395337|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.348|||<|0.0001|TWO_SIDED|95.0|0.246|0.493|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||0.493|0.246|<0.0001
73932768|NCT01639001|147395338|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.669||||0.127|TWO_SIDED|95.0|0.335|1.338|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||1.338|0.335|0.1270
73932769|NCT01639001|147395339|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.277|||<|0.0001|TWO_SIDED|95.0|0.186|0.412|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||0.412|0.186|<0.0001
73932770|NCT01639001|147395340|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.432|||<|0.0001|TWO_SIDED|95.0|0.307|0.61||2-sided Hochberg adjusted p-values|2 sided unstratified log rank||Based on the Cox Proportional hazards model.|||0.610|0.307|<0.0001
73971663|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.209||||0.0004|TWO_SIDED|95.0|-65.941|-14.477|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-14.477|-65.941|0.0004
73971664|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-41.052||||0.0011|TWO_SIDED|95.0|-68.965|-13.138|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-13.138|-68.965|0.0011
74030341|NCT01455428|147614809|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|3.161||0.5702|TWO_SIDED|95.0|-4.44|8.03||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||8.03|-4.44|0.5702
74030342|NCT01455428|147614810|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.87|STANDARD_ERROR_OF_MEAN|2.194||0.6929|TWO_SIDED|95.0|-3.46|5.2||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||5.20|-3.46|0.6929
74091628|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.56|||||TWO_SIDED|95.0|0.9|2.71|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 10A||2.71|0.90|
73932771|NCT01639001|147395341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.451|||<|0.0001|TWO_SIDED|95.0|3.79|11.11|||Mixed Models Analysis|||Analysis presented for QLQ-C30 Global QoL. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||11.11|3.79|<0.0001
74091629|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.87|||||TWO_SIDED|95.0|1.08|3.23|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 10A||3.23|1.08|
73932772|NCT01639001|147395341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.613||||0.014|TWO_SIDED|95.0|0.73|6.49|||Mixed Models Analysis|||Analysis presented for QLQ-C30 cognitive functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||6.49|0.73|0.0140
73932773|NCT01639001|147395341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.652||||0.2427|TWO_SIDED|95.0|-1.12|4.42|||Mixed Models Analysis|||Analysis presented for QLQ-C30 emotional functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||4.42|-1.12|0.2427
73865028|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|42.14|||||TWO_SIDED|95.0|27.08|56.98|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||56.98|27.08|
73865029|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|40.56|||||TWO_SIDED|95.0|25.91|55.15|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||55.15|25.91|
73932774|NCT01639001|147395341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.7267|||<|0.0001|TWO_SIDED|95.0|4.15|9.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 physical functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||9.30|4.15|<0.0001
73932775|NCT01639001|147395341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.8109||||0.0003|TWO_SIDED|95.0|3.15|10.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 role functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||10.47|3.15|0.0003
73932776|NCT01639001|147395341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.594||||0.014|TWO_SIDED|95.0|1.13|10.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 social functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||10.06|1.13|0.0140
73932777|NCT01639001|147395342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.0432||||0.0016|TWO_SIDED|95.0|-9.79|-2.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 appetite loss. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-2.30|-9.79|0.0016
73932778|NCT01639001|147395342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.5026||||0.0263|TWO_SIDED|95.0|0.53|8.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 constipation. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||8.47|0.53|0.0263
73932779|NCT01639001|147395342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.8085|||<|0.0001|TWO_SIDED|95.0|12.94|18.68|||Mixed Models Analysis|||Analysis presented for QLQ-C30 diarrhea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||18.68|12.94|<0.0001
73932780|NCT01639001|147395342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.7449|||<|0.0001|TWO_SIDED|95.0|-11.3|-4.19|||Mixed Models Analysis|||Analysis presented for QLQ-C30 dyspnea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-4.19|-11.30|<0.0001
73971665|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-42.509|||<|0.0001|TWO_SIDED|95.0|-60.902|-24.116|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-24.116|-60.902|<.0001
74030343|NCT01455428|147614811|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.84|STANDARD_ERROR_OF_MEAN|1.92||0.1403|TWO_SIDED|95.0|-6.63|0.94||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||0.94|-6.63|0.1403
74030344|NCT01455428|147614812|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-0.86|-0.39||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.||-0.39|-0.86|<0.0001
73865030|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-3.1|||||TWO_SIDED|95.0|-10.2|3.89|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||3.89|-10.20|
73865031|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.74|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||28.83|12.74|
73865032|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.74|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||28.83|12.74|
73865033|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.75|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||28.83|12.75|
73932781|NCT01639001|147395342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.4915||||0.0001|TWO_SIDED|95.0|-9.82|-3.17|||Mixed Models Analysis|||Analysis presented for QLQ-C30 fatigue. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.17|-9.82|0.0001
73932782|NCT01639001|147395342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.6165||||0.2099|TWO_SIDED|95.0|-9.27|2.04|||Mixed Models Analysis|||Analysis presented for QLQ-C30 financial difficulties. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||2.04|-9.27|0.2099
73932783|NCT01639001|147395342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.7756||||0.0004|TWO_SIDED|95.0|-10.49|-3.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 insomnia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.06|-10.49|0.0004
73932784|NCT01639001|147395342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.519||||0.0902|TWO_SIDED|95.0|-5.43|0.4|||Mixed Models Analysis|||Analysis presented for QLQ-C30 nausea and vomiting. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.40|-5.43|0.0902
73932785|NCT01639001|147395342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.4349|||<|0.0001|TWO_SIDED|95.0|-11.42|-5.45|||Mixed Models Analysis|||Analysis presented for QLQ-C30 pain. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-5.45|-11.42|<0.0001
73932786|NCT01639001|147395343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.8547||||0.0039|TWO_SIDED|95.0|-8.15|-1.56|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 alopecia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-1.56|-8.15|0.0039
73932787|NCT01639001|147395343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.9957||||0.0004|TWO_SIDED|95.0|-10.85|-3.14|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 coughing. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.14|-10.85|0.0004
73932788|NCT01639001|147395343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5181||||0.7082|TWO_SIDED|95.0|-3.23|2.2|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dysphagia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||2.20|-3.23|0.7082
73932789|NCT01639001|147395343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.6471|||<|0.0001|TWO_SIDED|95.0|-11.85|-5.44|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dyspnoea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-5.44|-11.85|<0.0001
73932790|NCT01639001|147395343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.2504||||0.1284|TWO_SIDED|95.0|-2.86|0.36|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 haemoptysis. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.36|-2.86|0.1284
73932791|NCT01639001|147395343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.2363||||0.0265|TWO_SIDED|95.0|-7.98|-0.49|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in arm or shoulder. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.49|-7.98|0.0265
73865034|NCT02986854|147276105|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.0|||||TWO_SIDED|95.0|-1.31|1.35|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.35|-1.31|
73865035|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.82|||||TWO_SIDED|95.0|11.44|30.6|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||30.60|11.44|
73865036|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.67|||||TWO_SIDED|95.0|7.34|26.43|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||26.43|7.34|
73865037|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.77|||||TWO_SIDED|95.0|10.09|27.43|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||27.43|10.09|
73865038|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|4.15|||||TWO_SIDED|95.0|-3.8|12.04|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||12.04|-3.80|
73865039|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.33|||||TWO_SIDED|95.0|2.92|30.99|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||30.99|2.92|
73865040|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.3|||||TWO_SIDED|95.0|2.83|31.06|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||31.06|2.83|
73865041|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.31|||||TWO_SIDED|95.0|3.83|29.39|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||29.39|3.83|
73865042|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.03|||||TWO_SIDED|95.0|-11.35|11.39|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||11.39|-11.35|
73865043|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.87|||||TWO_SIDED|95.0|32.64|62.38|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||62.38|32.64|
73865044|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.18|||||TWO_SIDED|95.0|31.87|61.79|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||61.79|31.87|
73932792|NCT01639001|147395343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.2237||||0.0185|TWO_SIDED|95.0|-7.74|-0.71|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in chest. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.71|-7.74|0.0185
73932793|NCT01639001|147395343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.5901||||0.0075|TWO_SIDED|95.0|-7.95|-1.23|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in other parts. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-1.23|-7.95|0.0075
73932794|NCT01639001|147395343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6732||||0.2848|TWO_SIDED|95.0|-4.74|1.39|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 peripheral neuropathy. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||1.39|-4.74|0.2848
73932795|NCT01639001|147395343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.398||||0.0296|TWO_SIDED|95.0|-4.56|-0.24|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 sore mouth. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.24|-4.56|0.0296
73932796|NCT01639001|147395344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.9136||||0.0123|TWO_SIDED|95.0|0.85|6.98|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D VAS subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||6.98|0.85|0.0123
73932797|NCT01639001|147395345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0425||||0.032|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D Index score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.08|0.00|0.0320
73932798|NCT01639001|147395347|SUPERIORITY_OR_OTHER_LEGACY||Overall percent agreement|0.934|||||TWO_SIDED|95.0|0.914|0.949|||||95% CI for agreement rate is calculated by the Wilson (Score) Confidence Limit method with alpha=0.05|||0.949|0.914|
73932799|NCT01639001|147395347|SUPERIORITY_OR_OTHER_LEGACY||Kappa|0.847|||||TWO_SIDED|95.0|0.8065|0.8875|||||Kappa coefficient is a statistic which measures inter-rater agreement for qualitative (categorical) items.|||0.8875|0.8065|
73865045|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.53|||||TWO_SIDED|95.0|33.04|61.31|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||61.31|33.04|
73865046|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.69|||||TWO_SIDED|95.0|-8.6|10.04|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||10.04|-8.60|
73865047|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|35.48|||||TWO_SIDED|95.0|26.5|45.62|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||45.62|26.50|
74030345|NCT01455428|147614813|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-0.72|-0.27||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.||-0.27|-0.72|<0.0001
73865048|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.06|||||TWO_SIDED|95.0|24.94|44.28|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||44.28|24.94|
73865049|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.78|||||TWO_SIDED|95.0|25.78|44.93|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||44.93|25.78|
73865050|NCT02986854|147276106|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|1.42|||||TWO_SIDED|95.0|0.1|3.6|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||3.60|0.10|
73865051|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.39|||||TWO_SIDED|95.0|-6.08|4.94|||Miettinen & Nurminen score method|||Serogroup A- Day 4- Total seroresponse (Menveo-Menveo vs. Naive)||4.94|-6.08|
73865052|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|2.17|||||TWO_SIDED|95.0|-5.32|6.21|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||6.21|-5.32|
73865053|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.77|||||TWO_SIDED|95.0|-5.68|4.09|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.09|-5.68|
73865054|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-0.79|||||TWO_SIDED|95.0|-4.98|3.01|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||3.01|-4.98|
73865055|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|34.76|||||TWO_SIDED|95.0|22.38|44.07|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||44.07|22.38|
73865056|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|26.88|||||TWO_SIDED|95.0|14.67|36.13|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||36.13|14.67|
73865057|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|30.89|||||TWO_SIDED|95.0|19.42|37.97|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||37.97|19.42|
73865058|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|7.88|||||TWO_SIDED|95.0|-3.25|18.81|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||18.81|-3.25|
73865059|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-3.45|||||TWO_SIDED|95.0|-14.26|2.35|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||2.35|-14.26|
73865060|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|2.51|||||TWO_SIDED|95.0|-8.7|9.98|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||9.98|-8.70|
73865061|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-0.54|||||TWO_SIDED|95.0|-11.35|4.9|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.90|-11.35|
73865062|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-5.96|||||TWO_SIDED|95.0|-12.25|-0.57|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||-0.57|-12.25|
73865063|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|40.03|||||TWO_SIDED|95.0|25.37|50.92|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||50.92|25.37|
73865064|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|36.84|||||TWO_SIDED|95.0|22.14|47.9|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||47.90|22.14|
73865065|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.46|||||TWO_SIDED|95.0|24.79|47.57|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||47.57|24.79|
73932800|NCT01969838|147395350|NON_INFERIORITY|To evaluate the noninferiority of MMB over RUX, a conventional 2-sided confidence interval (CI) was calculated for the difference in splenic response rate (SRR) at Week 24: delta = prob(MMB) - 0.6\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared noninferior to RUX in SRR at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is the noninferiority proportion difference.|Proportion Difference - Stratified CMH|0.09||||0.014|TWO_SIDED|95.0|0.02|0.16|||Cochran-Mantel-Haenszel|||||0.16|0.02|0.014
74030346|NCT01455428|147614815|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.315||0.506|TWO_SIDED|95.0|-0.83|0.41||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.||0.41|-0.83|0.5060
73865066|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.19|||||TWO_SIDED|95.0|-8.44|14.73|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||14.73|-8.44|
73865067|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-3.47|||||TWO_SIDED|95.0|-14.28|2.31|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||2.31|-14.28|
73865068|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.89|||||TWO_SIDED|95.0|-7.4|11.6|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||11.60|-7.40|
73865069|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|0.13|||||TWO_SIDED|95.0|-10.7|5.66|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||5.66|-10.70|
73865070|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-7.37|||||TWO_SIDED|95.0|-13.89|-1.8|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||-1.80|-13.89|
73865071|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.98|||||TWO_SIDED|95.0|24.35|49.88|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||49.88|24.35|
73865072|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|37.92|||||TWO_SIDED|95.0|23.23|48.95|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||48.95|23.23|
74088784|NCT03135899|147730609|OTHER||Mean Difference (Final Values)|-0.157|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|90.0|-0.266|-0.047|||Mixed Models Analysis||BI 443651 1200 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||-0.047|-0.266|
73865073|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.46|||||TWO_SIDED|95.0|24.8|47.56|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||47.56|24.80|
73865074|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.06|||||TWO_SIDED|95.0|-10.51|12.6|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||12.60|-10.51|
73865075|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|7.75|||||TWO_SIDED|95.0|0.15|13.36|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||13.36|0.15|
74091630|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.53|1.49|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 11A||1.49|0.53|
73865076|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|4.38|||||TWO_SIDED|95.0|-3.15|9.24|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||9.24|-3.15|
73865077|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|6.09|||||TWO_SIDED|95.0|-1.41|9.55|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||9.55|-1.41|
73865078|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.37|||||TWO_SIDED|95.0|-2.48|9.54|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||9.54|-2.48|
73865079|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|39.86|||||TWO_SIDED|95.0|25.76|50.29|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||50.29|25.76|
73865080|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|48.05|||||TWO_SIDED|95.0|33.89|58.34|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||58.34|33.89|
73865081|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|43.91|||||TWO_SIDED|95.0|30.79|52.37|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||52.37|30.79|
73865082|NCT02986854|147276107|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-8.19|||||TWO_SIDED|95.0|-19.61|3.45|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||3.45|-19.61|
73865083|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.26|||||TWO_SIDED|95.0|0.93|1.7||||||Serogroup A-Vaccine comparison at day 4(Menveo-Menveo vs. Naive)||1.70|0.93|
73971666|NCT04800211|147483702|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-2.915||||0.7835|TWO_SIDED|95.0|-23.855|18.025|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||18.025|-23.855|0.7835
73971667|NCT04800211|147483703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|-0.769||||0.0002|TWO_SIDED|95.0|-1.228|-0.309|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||-0.309|-1.228|0.0002
73932801|NCT01969838|147395351|NON_INFERIORITY|To evaluate the noninferiority of MMB over RUX, a conventional 2-sided CI was calculated for the difference in TSS response rate at Week 24: delta = prob(MMB) - 0.67\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared to be noninferior to RUX in TSS response rate at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is called the noninferiority proportion difference.|Proportion Difference - Stratified CMH|0.0||||0.98|TWO_SIDED|95.0|-0.08|0.08|||Cochran-Mantel-Haenszel|||||0.08|-0.08|0.98
73932802|NCT01969838|147395352|SUPERIORITY||Rate ratio|0.28|||<|0.001|TWO_SIDED|95.0|0.19|0.43|||Negative Binomial Model, Adjusted||A smaller ratio represents larger benefit.|||0.43|0.19|<0.001
73932803|NCT01969838|147395353|SUPERIORITY||Proportion Difference - Stratified CMH|0.18|||<|0.001|TWO_SIDED|95.0|0.09|0.26|||Cochran-Mantel-Haenszel||A larger proportion represents larger benefit.|||0.26|0.09|<0.001
73932804|NCT01969838|147395354|SUPERIORITY||Proportion Difference - Stratified CMH|-0.1||||0.019|TWO_SIDED|95.0|-0.19|-0.02|||Cochran-Mantel-Haenszel||A smaller proportion represents larger benefit.|||-0.02|-0.19|0.019
73932805|NCT00807092|147395363|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.666||||95.0|-1.332|1.306||A statistical significant threshold p less than 0.025|ANCOVA|Treatment and strata as factors; baseline (visit 2) value of mean IAUC(0-4hours) as covariate|BIAsp 30 - BHI 30|"The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment greater than or equal to 0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment less than 0 mol\*h/L"||1.306|-1.332|
73932806|NCT00807092|147395364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.178|STANDARD_ERROR_OF_MEAN|1.0||0.2412||95.0|-0.802|3.157||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Breakfast|"Null hypothesis and alternative hypothesis for breakfast:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment≠0 mol\*h/L"||3.157|-0.802|0.2412
73932807|NCT00807092|147395364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.318|STANDARD_ERROR_OF_MEAN|1.216||0.794||95.0|-2.724|2.087||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Lunch|"Null hypothesis and alternative hypothesis for lunch:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment≠0 mol\*h/L"||2.087|-2.724|0.794
73932808|NCT00807092|147395364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.749||||0.3093||95.0|-2.2|0.703||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Dinner|"Null hypothesis and alternative hypothesis for dinner:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment≠0 mol\*h/L"||0.703|-2.2|0.3093
73932809|NCT00807092|147395365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.448|STANDARD_ERROR_OF_MEAN|0.261||0.0891||95.0|-0.069|0.964||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.964|-0.069|0.0891
74008271|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.3|||=|0.2887|TWO_SIDED|95.0|-1.0|0.3|||Mixed Models Analysis|||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-1.0|= 0.2887
73932810|NCT00807092|147395367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.495|STANDARD_ERROR_OF_MEAN|0.247||0.0472||95.0|0.006|0.984||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.984|0.0060|0.0472
73932811|NCT00807092|147395368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.676||95.0|-0.41|0.63||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 2) value of BG as covariate|Before breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.63|-0.41|0.676
73932812|NCT00807092|147395368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.23||||0.026||95.0|0.15|2.31||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||2.31|0.15|0.026
73932813|NCT00807092|147395368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.5||95.0|-0.53|1.08||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.08|-0.53|0.5
73932814|NCT00807092|147395368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.747||95.0|-0.86|1.19||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.19|-0.86|0.747
73932815|NCT00807092|147395368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.581||95.0|-1.23|0.69||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.69|-1.23|0.581
73932816|NCT00807092|147395368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.326||95.0|-1.42|0.48||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.48|-1.42|0.326
73932817|NCT00807092|147395368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.643||95.0|-0.61|0.99||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Bedtime|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.99|-0.61|0.643
73932818|NCT00807092|147395368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.008||95.0|0.21|1.33||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|3 AM|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.33|0.21|0.0080
73971668|NCT04800211|147483703|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|-0.52||||0.0175|TWO_SIDED|95.0|-0.972|-0.068|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||-0.068|-0.972|0.0175
73971669|NCT04800211|147483704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|2.408||||0.0362|TWO_SIDED|95.0|0.11|4.705|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||4.705|0.110|0.0362
74091631|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.66|1.87|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 11A||1.87|0.66|
73865084|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.34|||||TWO_SIDED|95.0|0.98|1.82||||||Serogroup A-Vaccine comparison at day 4(Menactra-Menveo vs. Naive)||1.82|0.98|
73865085|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.29|||||TWO_SIDED|95.0|0.97|1.72||||||Serogroup A-Vaccine comparison at day 4(Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||1.72|0.97|
73865086|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.94|||||TWO_SIDED|95.0|0.76|1.17||||||Serogroup A-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.17|0.76|
73865087|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|5.19|||||TWO_SIDED|95.0|2.84|9.47||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||9.47|2.84|
73865088|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.1|||||TWO_SIDED|95.0|2.24|7.5||||||Serogroup A-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||7.50|2.24|
73932819|NCT00807092|147395368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.274||95.0|-0.22|0.75||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Average|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.75|-0.22|0.274
73932820|NCT00807092|147395369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.062||95.0|-0.05|2.04||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Breakfast|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||2.04|-0.05|0.062
73932821|NCT00807092|147395369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.933||95.0|-1.12|1.22||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Lunch|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.22|-1.12|0.933
73932822|NCT00807092|147395369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.922||95.0|-1.16|1.05||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Dinner|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.05|-1.16|0.922
73932823|NCT00807092|147395369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29||||0.313||95.0|-0.28|0.85||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Average|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.85|-0.28|0.313
74008272|NCT03627767|147566491|SUPERIORITY||LSM difference|-1.0|||=|0.0025|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.6|= 0.0025
74091632|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.7|||||TWO_SIDED|95.0|0.89|3.27|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 12F||3.27|0.89|
73865089|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.62|||||TWO_SIDED|95.0|2.62|8.15||||||Serogroup A-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||8.15|2.62|
73865090|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.27|||||TWO_SIDED|95.0|0.84|1.91||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.91|0.84|
73865091|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.54|||||TWO_SIDED|95.0|4.84|8.85||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||8.85|4.84|
73932824|NCT00807092|147395370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.187|STANDARD_ERROR_OF_MEAN|0.371||0.6149||95.0|-0.547|0.921||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (visit 2) value of mean MAGE as covariate||The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||0.921|-0.547|0.6149
73932825|NCT00807092|147395371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.328|STANDARD_ERROR_OF_MEAN|0.577||0.5706||95.0|-0.813|1.468||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of GA as covariate||"The null hypothesis (H0) was:~H0: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment≠0 %"||1.468|-0.813|0.5706
73865092|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.37|||||TWO_SIDED|95.0|5.44|9.98||||||Serogroup A-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||9.98|5.44|
73865093|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.94|||||TWO_SIDED|95.0|5.23|9.21||||||Serogroup A-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||9.21|5.23|
73865094|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.89|||||TWO_SIDED|95.0|0.72|1.1||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.10|0.72|
73865095|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|between group GMT ratios|3.43|||||TWO_SIDED|95.0|1.95|6.04||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||6.04|1.95|
73865096|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||TWO_SIDED|95.0|1.21|3.77||||||Serogroup C-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||3.77|1.21|
73865097|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.72|||||TWO_SIDED|95.0|1.6|4.64||||||Serogroup C-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.64|1.60|
73865098|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.61|||||TWO_SIDED|95.0|1.07|2.4||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||2.40|1.07|
73865099|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.75|||||TWO_SIDED|95.0|7.51|25.19||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||25.19|7.51|
73932826|NCT00807092|147395372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.113||0.8598||95.0|-0.243|0.243||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of HbA1c as covariate||"The null hypothesis (H0) was:~H0: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment≠0%"||0.243|-0.243|0.8598
73865100|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.42|||||TWO_SIDED|95.0|7.31|24.66||||||Serogroup C-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||24.66|7.31|
73865101|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.59|||||TWO_SIDED|95.0|7.7|24.0||||||Serogroup C-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||24.00|7.70|
73865102|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.02|||||TWO_SIDED|95.0|0.67|1.56||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.56|0.67|
73932827|NCT00807092|147395373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.054|STANDARD_ERROR_OF_MEAN|0.128||0.671||95.0|-0.307|0.198||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 3.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"||0.198|-0.307|0.671
73865103|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|19.43|||||TWO_SIDED|95.0|13.73|27.51||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||27.51|13.73|
73865104|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|17.72|||||TWO_SIDED|95.0|12.5|25.12||||||Serogroup C-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||25.12|12.50|
73865105|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|18.57|||||TWO_SIDED|95.0|13.4|25.73||||||Serogroup C-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||25.73|13.40|
73865106|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.1|||||TWO_SIDED|95.0|0.86|1.4||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.40|0.86|
73865107|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.88|||||TWO_SIDED|95.0|1.13|3.11||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||3.11|1.13|
73865108|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.46|||||TWO_SIDED|95.0|1.48|4.08||||||Serogroup W-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||4.08|1.48|
73865109|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||TWO_SIDED|95.0|1.33|3.44||||||Serogroup W-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||3.44|1.33|
73865110|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.76|||||TWO_SIDED|95.0|0.53|1.1||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.10|0.53|
73865111|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.04|||||TWO_SIDED|95.0|4.05|12.22||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||12.22|4.05|
73865112|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|8.99|||||TWO_SIDED|95.0|5.16|15.66||||||Serogroup W-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||15.66|5.16|
73865113|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.94|||||TWO_SIDED|95.0|4.72|13.35||||||Serogroup W-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||13.35|4.72|
73865114|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.78|||||TWO_SIDED|95.0|0.54|1.14||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.14|0.54|
73865115|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|25.21|||||TWO_SIDED|95.0|17.83|35.65||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||35.65|17.83|
73865116|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|34.06|||||TWO_SIDED|95.0|24.06|48.23||||||Serogroup W-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||48.23|24.06|
73865117|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|29.24|||||TWO_SIDED|95.0|21.09|40.52||||||Serogroup W-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||40.52|21.09|
73957812|NCT00383188|147451053|SUPERIORITY||LSM Difference|2.21|STANDARD_ERROR_OF_MEAN|1.918||0.25|TWO_SIDED|95.0|-1.561|5.981|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||5.981|-1.561|0.2500
73865118|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.74|||||TWO_SIDED|95.0|0.58|0.94||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||0.94|0.58|
73865119|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.35|||||TWO_SIDED|95.0|1.36|4.07||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||4.07|1.36|
73957813|NCT00414206|147451083|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANCOVA|||||||>0.05
73932828|NCT00807092|147395373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.038||0.7544||95.0|-0.088|0.064||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 2.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"||0.064|-0.088|0.7544
73932829|NCT04116229|147395375|EQUIVALENCE|"Alternative hypothesis: people with normal-weight BMI have lower DBSI restricted fraction, or putative cellularity, than people with obesity.~Null hypothesis: DBSI restricted fraction, or putative cellularity, is not different between normal-weight and obese groups."|Median Difference (Final Values)|0.05||||0.28|TWO_SIDED|||||a priori threshold: p \< 0.05|Independent-Samples Median Test|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.||||0.28
73932830|NCT04116229|147395375|EQUIVALENCE|"Alternative hypothesis: people with normal-weight BMI have lower DBSI hindered fraction, or putative vasogenic edema, than people with obesity.~Null hypothesis: DBSI hindered fraction, or putative vasogenic edema, is not different between normal-weight and obese groups."|Median Difference (Final Values)|0.18||||0.03|TWO_SIDED|||||a priori threshold: p \< 0.05|Independent-Samples Median Test|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.||||0.03
73932831|NCT04116229|147395376|OTHER|"Alternative hypothesis: Worse crystallized cognitive function will relate to greater putative vasogenic edema (DBSI HF) in white matter tracts.~Null hypothesis: Crystallized cogntive function is not related to DBSI HF."|Slope|-0.69||||0.01|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.01
73932832|NCT04116229|147395376|OTHER|"Alternative hypothesis: Worse fluid cognitive function will relate to greater putative vasogenic edema (DBSI HF) in white matter tracts.~Null hypothesis: Fluid cogntive function is not related to DBSI HF."|Slope|0.52||||0.1|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.10
73932833|NCT04116229|147395376|OTHER|"Alternative hypothesis: Worse crystallized cognitive function will relate to greater putative cellularity (DBSI RF) in white matter tracts.~Null hypothesis: Crystallized cognitive function is not related to DBSI RF."|Slope|-0.45||||0.01|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.01
73932834|NCT04116229|147395376|OTHER|"Alternative hypothesis: Worse fluid cognitive function will relate to greater putative cellularity (DBSI RF) in white matter tracts.~Null hypothesis: Fluid cognitive function is not related to DBSI RF."|Slope|0.22||||0.1|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.10
73932835|NCT04116229|147395377|OTHER|"Alternative hypothesis: higher levels of insulin, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Insulin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.18|||>|0.46|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||>0.46
73932836|NCT04116229|147395377|OTHER|"Alternative hypothesis: higher levels of insulin, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Insulin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.22|||>|0.5|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||>0.5
73971670|NCT04800211|147483704|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.692||||0.2142|TWO_SIDED|95.0|-0.569|3.953|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.953|-0.569|0.2142
74008273|NCT03627767|147566491|SUPERIORITY||LSM difference|-0.6|||||TWO_SIDED|95.0|-1.0|-0.2||||||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.0|
74088785|NCT03135899|147730611|OTHER||Geometric Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.168|||TWO_SIDED|90.0|0.595|0.977|||Mixed Models Analysis||BI 443651 100 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.977|0.595|
74091633|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.4|||||TWO_SIDED|95.0|1.24|4.62|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 12F||4.62|1.24|
73932837|NCT04116229|147395378|OTHER|"Alternative hypothesis: higher levels of leptin, a pro-inflammatory marker and satiety hormone, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Leptin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.15||||0.62|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.62
73932838|NCT04116229|147395378|OTHER|"Alternative hypothesis: higher levels of leptin, a pro-inflammatory marker and satiety hormone, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Leptin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.07||||0.82|TWO_SIDED||||||Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.82
73932839|NCT04116229|147395379|OTHER|"Alternative hypothesis: higher levels of ghrelin, an anti-inflammatory marker and hunger hormone, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Ghrelin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.19||||0.53|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.53
73971671|NCT04800211|147483705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-39.501||||0.025|TWO_SIDED|95.0|-75.396|-3.605|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-3.605|-75.396|0.0250
73971672|NCT04800211|147483705|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.94||||0.9997|TWO_SIDED|95.0|-37.896|32.016|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||32.016|-37.896|0.9997
73971673|NCT04800211|147483706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-54.398||||0.6778|TWO_SIDED|95.0|-177.281|68.485|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||68.485|-177.281|0.6778
73971674|NCT04800211|147483706|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-48.395||||0.7497|TWO_SIDED|95.0|-168.697|71.908|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||71.908|-168.697|0.7497
73971675|NCT04800211|147483707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.01||||0.0003|TWO_SIDED|95.0|-32.447|-7.573|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-7.573|-32.447|0.0003
74030347|NCT01455428|147614816|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.285||0.7247|TWO_SIDED|95.0|-0.66|0.46||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.||0.46|-0.66|0.7247
74030348|NCT03303339|147614817|OTHER||Maximum Tolerated Dose|60.0|||||TWO_SIDED|||||||||||||
73971676|NCT04800211|147483707|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-22.566|||<|0.0001|TWO_SIDED|95.0|-34.837|-10.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-10.295|-34.837|<.0001
73971677|NCT04800211|147483708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-179.365|||<|0.0001|TWO_SIDED|95.0|-225.708|-133.022|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-133.022|-225.708|<.0001
73971678|NCT04800211|147483708|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-153.22|||<|0.0001|TWO_SIDED|95.0|-198.93|-107.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-107.509|-198.930|<.0001
73971679|NCT04800211|147483709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.569|||<|0.0001|TWO_SIDED|95.0|-3.084|-2.054|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.054|-3.084|<.0001
73971680|NCT04800211|147483709|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.586|||<|0.0001|TWO_SIDED|95.0|-3.092|-2.081|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.081|-3.092|<.0001
73971681|NCT04800211|147483711|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.42||||0.0839|TWO_SIDED|95.0|-0.19|3.04|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.04|-0.19|0.0839
73971682|NCT04800211|147483711|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|2.1||||0.0089|TWO_SIDED|95.0|0.53|3.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.66|0.53|0.0089
74030349|NCT01905397|147614845|SUPERIORITY||Difference in proportions|0.05||||0.27|ONE_SIDED||||||t-test, 1 sided|||||||0.27
74030350|NCT00455858|147614862|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-1.356|||<|0.0001||95.0|-1.368|-1.344|||t-test|||||-1.344|-1.368|<.0001
74030351|NCT00455858|147614863|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-1.338|||<|0.0001||95.0|-1.35|-1.327|||t-test|||||-1.327|-1.350|<.0001
74030352|NCT00455858|147614864|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-69.553|||<|0.0001||95.0|-70.047|-69.06|||Paired t-test|||Estimated mean decrease in FPG at week 12||-69.060|-70.047|<.0001
73865120|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.62|||||TWO_SIDED|95.0|1.51|4.54||||||Serogroup Y-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||4.54|1.51|
73865121|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.48|||||TWO_SIDED|95.0|1.48|4.14||||||Serogroup Y-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.14|1.48|
73865122|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.9|||||TWO_SIDED|95.0|0.61|1.33||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.33|0.61|
73865123|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.82|||||TWO_SIDED|95.0|5.47|17.64||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||17.64|5.47|
73865124|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.55|||||TWO_SIDED|95.0|5.31|17.19||||||Serogroup Y-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||17.19|5.31|
73865125|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.69|||||TWO_SIDED|95.0|5.59|16.79||||||Serogroup Y-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||16.79|5.59|
73865126|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.03|||||TWO_SIDED|95.0|0.69|1.54||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.54|0.69|
73865127|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|28.52|||||TWO_SIDED|95.0|20.23|40.2||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||40.20|20.23|
73932840|NCT04116229|147395379|OTHER|"Alternative hypothesis: higher levels of ghrelin, an anti-inflammatory marker and hunger hormone, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Ghrelin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.12||||0.71|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.71
73865128|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|26.94|||||TWO_SIDED|95.0|19.09|38.02||||||Serogroup Y-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||38.02|19.09|
73865129|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|27.73|||||TWO_SIDED|95.0|20.1|38.26||||||Serogroup Y-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||38.26|20.10|
73865130|NCT02986854|147276108|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.06|||||TWO_SIDED|95.0|0.83|1.35||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.35|0.83|
73865131|NCT00324233|147276110|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||equivalence testing|||||||0.56
73865132|NCT01972789|147276126|NON_INFERIORITY|This is a non-inferiority study design, with a pre-specified non-inferiority margin of 5 letters between intensive and relaxed groups. That is, if the change from Baseline in BCVA at Month 24 in the intensive group is not more than 5 letters higher than the relaxed group, then the relaxed group is regarded not inferior to the intensive group|Odds Ratio (OR)|0.4||||0.787|TWO_SIDED|95.0|-2.51|3.32|||Mixed Models Analysis|||||3.32|-2.51|0.787
73865133|NCT01972789|147276127|OTHER||Odds Ratio (OR)|-0.31||||0.833|TWO_SIDED|95.0|-3.2|2.58|||Mixed Models Analysis|||||2.58|-3.20|0.833
73865134|NCT01972789|147276128|OTHER||Odds Ratio (OR)|-21.39||||0.054|TWO_SIDED|95.0|-43.17|0.39|||Mixed Models Analysis|||||0.39|-43.17|0.054
73865135|NCT01972789|147276129|OTHER||Negative Binomial Regression|1.11||||0.001|TWO_SIDED|95.0|1.04|1.18|||Mixed Model|||||1.18|1.04|0.001
73865136|NCT01972789|147276130|OTHER||Odds Ratio (OR)|0.26||||0.338|TWO_SIDED|95.0|-0.28|0.8|||Mixed Models Analysis|||||0.80|-0.28|0.338
73865137|NCT01972789|147276131|OTHER||Odds Ratio (OR)|1.44||||0.284|TWO_SIDED|95.0|0.74|2.8|||Regression, Logistic|||Month 12||2.80|0.74|0.284
74008274|NCT03627767|147566492|SUPERIORITY||Difference in percentage|1.0|||=|0.4244|TWO_SIDED|95.0|-1.4|3.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.4|-1.4|= 0.4244
74030353|NCT00455858|147614864|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-72.159|||<|0.0001||95.0|-72.647|-71.671|||Paired t-test|||Estimated mean decrease in FPG at week 20||-71.671|-72.647|<.0001
73971683|NCT04800211|147483712|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.26||||0.7101|TWO_SIDED|95.0|-1.13|1.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||1.66|-1.13|0.7101
73971684|NCT04800211|147483712|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.24||||0.7325|TWO_SIDED|95.0|-1.12|1.59|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||1.59|-1.12|0.7325
73865138|NCT01972789|147276131|OTHER||Odds Ratio (OR)|1.29||||0.407|TWO_SIDED|95.0|0.71|2.33|||Regression, Logistic|||Month 24||2.33|0.71|0.407
73932841|NCT04116229|147395380|OTHER|"Alternative hypothesis: greater HOMA-IR, where higher HOMA-IR indicates greater insulin resistance, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: HOMA-IR levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.19||||0.53|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.53
73932842|NCT04116229|147395380|OTHER|"Alternative hypothesis: greater HOMA-IR, where higher HOMA-IR indicates greater insulin resistance, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: HOMA-IR levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.21||||0.5|TWO_SIDED||||||Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.5
73932843|NCT04116229|147395381|OTHER|"Alternative hypothesis: higher levels of IL-10, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: IL-10 levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.5||||0.09|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.09
73932844|NCT04116229|147395381|OTHER|"Alternative hypothesis: higher levels of IL-10, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: IL-10 levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.2||||0.45|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.45
73932845|NCT04116229|147395382|OTHER|"Alternative hypothesis: higher levels of adiponectin, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Adiponectin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.38||||0.19|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.19
74008275|NCT03627767|147566492|SUPERIORITY||Difference in percentage|-0.3|||=|0.8092|TWO_SIDED|95.0|-3.1|2.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||2.4|-3.1|= 0.8092
74008276|NCT03627767|147566492|SUPERIORITY||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-4.1|1.0||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.0|-4.1|
74030354|NCT01052012|147614887|SUPERIORITY||LS Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|0.597||0.1473|TWO_SIDED|95.0|-2.11|0.33|||ANCOVA|With pooled site and treatment group as factors and incision length as a covariate.||||0.33|-2.11|0.1473
74030355|NCT01052012|147614887|SUPERIORITY||LS Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.547||0.0601|TWO_SIDED|95.0|-2.16|0.05|||ANCOVA|with pooled site and treatment group as factors and incision length as a covariate.||||0.05|-2.16|0.0601
73865139|NCT01972789|147276132|OTHER||Odds Ratio (OR)|0.35||||0.217|TWO_SIDED|95.0|0.12|1.04|||Regression, Logistic|||||1.04|0.12|0.217
73865140|NCT01972789|147276133|OTHER||Odds Ratio (OR)|0.84||||0.615|TWO_SIDED|95.0|0.42|1.66|||Regression, Logistic|||||1.66|0.42|0.615
73865141|NCT01972789|147276134|OTHER||Odds Ratio (OR)|1.08||||0.819|TWO_SIDED|95.0|0.54|2.18|||Regression, Logistic|||||2.18|0.54|0.819
73865142|NCT01972789|147276136|OTHER||Odds Ratio (OR)|4.32||||0.565|TWO_SIDED|95.0|0.03|630.5|||Regression, Logistic|||||630.5|0.03|0.565
73865143|NCT01972789|147276137|OTHER||Odds Ratio (OR)|1.39||||0.034|TWO_SIDED|95.0|1.03|1.9|||Regression, Logistic|||||1.90|1.03|0.034
73865144|NCT01707381|147276141|OTHER||Treatment difference|-1.773|||<|0.001|TWO_SIDED|95.0|-2.38|-1.166|||ANCOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.|||-1.166|-2.380|<0.001
73865145|NCT01707381|147276142|OTHER||Bonferroni t-test used for paired compar|0.01|||<|0.05|TWO_SIDED||||||ANOVA||the bonferroni result applies to nocturnal supine OPP data comparing BOL group to timolol group|Statistical analysis of nocturnal (supine) OPP was performed among baseline, the BOL-303259-X treatment and timolol treatment using ANOVA. the criteria for statistical significance was P\<0.05. Post hoc Bonferroni T-tests were then utilized to compare BOL and timolol groups.||||<0.05
73932846|NCT04116229|147395382|OTHER|"Alternative hypothesis: higher levels of adiponectin, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Adiponectin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.2||||0.52|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.52
73932847|NCT04116229|147395383|OTHER|"Alternative hypothesis: higher levels of TNF-alpha, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: TNF-alpha levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.05||||0.9|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.90
73932848|NCT04116229|147395383|OTHER|"Alternative hypothesis: higher levels of TNF-alpha, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: TNF-alpha levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.04||||0.87|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.87
73932849|NCT04116229|147395384|OTHER|"Alternative hypothesis: higher levels of MCP-1, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: MCP-1 levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.34||||0.26|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.26
73932850|NCT04116229|147395384|OTHER|"Alternative hypothesis: higher levels of MCP-1, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: MCP-1 levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.12||||0.71|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.71
73971685|NCT04800211|147483713|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.48||||0.0136|TWO_SIDED|95.0|0.31|2.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.66|0.31|0.0136
73865146|NCT01707381|147276143|OTHER||Mean Difference (Final Values)|-1.77||||0.004|TWO_SIDED|95.0|-2.915|-0.625|||ANOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.|||-0.625|-2.915|0.004
73865147|NCT00086411|147276145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32|STANDARD_ERROR_OF_MEAN|0.2734|<|0.017|TWO_SIDED|95.0|0.77|2.25||The p-value was adjusted for multiple comparisons.|GEE model for repeated binary outcomes|Model included hx of heavy smoking, elevated depression, cigarettes per day, gender, and race|The above was for the main effect of BUP versus NTX on cessation.|Rates of abstinence were addressed using a generalized estimating equations (GEE) logistic regression model. Counseling type and medication type were entered as the main explanatory variables along with time and the interaction of these factors, together with some covariates (described below). The sample size provided 80% power to detect a difference of about 14% between groups across three time points (i.e., 12, 26, and 52 weeks post-treatment initiation.||2.25|0.77|<0.017
73865148|NCT00279812|147276147|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73865149|NCT00279812|147276148|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73865150|NCT00279812|147276149|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73865151|NCT03495102|147276218|SUPERIORITY||Mean Difference (Net)|-0.17||||0.003|TWO_SIDED|95.0|-0.29|-0.06|||Mixed Models Analysis|||||-0.06|-0.29|0.003
73865152|NCT03495102|147276218|SUPERIORITY||Mean Difference (Net)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.45|-0.22|||Mixed Models Analysis|||||-0.22|-0.45|<0.001
73865153|NCT03495102|147276219|SUPERIORITY||Mean Difference (Net)|-0.9||||0.001|TWO_SIDED|95.0|-1.4|-0.4|||Mixed Models Analysis|||||-0.4|-1.4|0.001
73865154|NCT03495102|147276219|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-2.1|-1.1|||Mixed Models Analysis|||||-1.1|-2.1|<0.001
74008277|NCT03627767|147566492|SUPERIORITY||Difference in percentage|46.7|||<|0.0001|TWO_SIDED|95.0|39.2|54.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||54.2|39.2|< 0.0001
73932851|NCT04116229|147395385|OTHER|"Alternative hypothesis: higher levels of CRP, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: CRP levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.19||||0.54|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.54
73932852|NCT04116229|147395385|OTHER|"Alternative hypothesis: higher levels of CRP, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: CRP levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.09||||0.77|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.77
73932853|NCT01229228|147395386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.417|STANDARD_ERROR_OF_MEAN|2.7891|<|0.001|TWO_SIDED|95.0|16.923|27.91|||ANCOVA|||||27.910|16.923|<0.001
73932854|NCT03759223|147395387|SUPERIORITY|||||||0.04||||||0:24 weeks|Mixed Models Analysis|||||||.04
73932855|NCT03759223|147395387|SUPERIORITY|||||||0.05||||||0:24 weeks|Mixed Models Analysis|||||||.05
73932856|NCT03759223|147395387|SUPERIORITY|||||||0.58||||||12:12 weeks|Mixed Models Analysis|||||||.58
73932857|NCT01599650|147395412|SUPERIORITY_OR_OTHER||difference in LS mean|10.0|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|7.3|12.8|||ANOVA|||||12.8|7.3|<0.0001
73932858|NCT01599650|147395412|SUPERIORITY_OR_OTHER||difference in LS Means|8.7|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|5.8|11.6|||ANOVA|||||11.6|5.8|<0.0001
73932859|NCT03282955|147395428|NON_INFERIORITY|Non-inferiority margin= 1.151||||||0.025|||||||t-test, 1 sided|||||||0.025
73932860|NCT04154631|147395464|SUPERIORITY||Time by treatment interaction coeff.|-10.91|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Immediate TranS-C (Standard/Adapted combined) versus UC-DT on change in sleep disturbance from pre to post.||||<0.001
73971686|NCT04800211|147483713|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.94||||0.0009|TWO_SIDED|95.0|0.8|3.08|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.08|0.80|0.0009
74008278|NCT03627767|147566492|SUPERIORITY||Difference in percentage|63.6|||<|0.0001|TWO_SIDED|95.0|57.2|70.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||70.0|57.2|< 0.0001
73932861|NCT04154631|147395464|SUPERIORITY||Coefficient of indirect effect|0.17||||0.95|TWO_SIDED|95.0|-4.62|4.95|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||4.95|-4.62|0.95
73932862|NCT04154631|147395464|SUPERIORITY||Coefficient of indirect effect|0.09||||0.95|TWO_SIDED|95.0|-2.39|2.56|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.56|-2.39|0.95
73932863|NCT04154631|147395464|SUPERIORITY||Coefficient of indirect effect|-0.16||||0.88|TWO_SIDED|95.0|-2.31|1.98|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||1.98|-2.31|0.88
73932864|NCT04154631|147395464|SUPERIORITY||Coefficient of indirect effect|-0.13||||0.88|TWO_SIDED|95.0|-3.1|2.31|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||2.31|-3.10|0.88
73932865|NCT04154631|147395464|SUPERIORITY||Coefficient of indirect effect|-0.5||||0.79|TWO_SIDED|95.0|-2.18|1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.66|-2.18|0.79
73932866|NCT04154631|147395464|SUPERIORITY||Coefficient of indirect effect|-0.26||||0.79|TWO_SIDED|95.0|-2.18|1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.66|-2.18|0.79
73932867|NCT04154631|147395465|SUPERIORITY||time by treatment interaction coeff.|-0.03||||0.77|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Acceptability Intervention Measure (AIM) from baseline (post-training) to post-treatment.||||0.77
73932868|NCT04154631|147395466|SUPERIORITY||Time by treatment interaction coeff.|-9.52|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in sleep-related impairment from pre to post.||||<0.001
73971687|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.038||||0.9294|TWO_SIDED|95.0|-0.795|0.87|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.870|-0.795|0.9294
73932869|NCT04154631|147395466|SUPERIORITY||Coefficient of indirect effect|0.26||||0.92|TWO_SIDED|95.0|-5.04|5.56|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||5.56|-5.04|0.92
73971688|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.277||||0.529|TWO_SIDED|95.0|-0.587|1.142|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.142|-0.587|0.5290
73971689|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.508||||0.2291|TWO_SIDED|95.0|-1.337|0.321|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.321|-1.337|0.2291
73932870|NCT04154631|147395466|SUPERIORITY||Coefficient of indirect effect|0.1||||0.92|TWO_SIDED|95.0|-2.04|2.24|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.24|-2.04|0.92
73932871|NCT04154631|147395466|SUPERIORITY||Coefficient of indirect effect|-0.39||||0.78|TWO_SIDED|95.0|-3.1|2.31|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||2.31|-3.10|0.78
73932872|NCT04154631|147395466|SUPERIORITY||Coefficient of indirect effect|-0.3||||0.78|TWO_SIDED|95.0|-2.35|1.75|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||1.75|-2.35|0.78
73971690|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.525||||0.2179|TWO_SIDED|95.0|-0.311|1.361|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.361|-0.311|0.2179
74008279|NCT03627767|147566492|SUPERIORITY||Difference in percentage|17.0|||||TWO_SIDED|95.0|10.4|23.5||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||23.5|10.4|
74030356|NCT01052012|147614887|SUPERIORITY||LS Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.233||0.1483|TWO_SIDED|95.0|-0.8|0.12|||ANCOVA|with pooled site and treatment group as factors and incision length as a covariate.||||0.12|-0.80|0.1483
73932873|NCT04154631|147395466|SUPERIORITY||Coefficient of indirect effect|-0.43||||0.84|TWO_SIDED|95.0|-4.66|3.8|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||3.80|-4.66|0.84
73932874|NCT04154631|147395466|SUPERIORITY||Coefficient of indirect effect|-0.18||||0.84|TWO_SIDED|95.0|-1.94|1.58|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.58|-1.94|0.84
73932875|NCT04154631|147395467|SUPERIORITY||Time by treatment interaction coeff.|1.63|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in Composite Sleep Health Score from pre to post.||||<0.001
73932876|NCT04154631|147395468|SUPERIORITY||Time by treatment interaction coeff.|-5.12|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in functional impairment from pre to post.||||<0.001
73932877|NCT04154631|147395468|SUPERIORITY||Coefficient of indirect effect|-3.12|||<|0.001|TWO_SIDED|95.0|-4.58|-1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-1.66|-4.58|<0.001
73932878|NCT04154631|147395468|SUPERIORITY||Coefficient of indirect effect|-3.81|||<|0.001|TWO_SIDED|95.0|-5.41|-2.22|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep-related impairment (PROMIS-SRI). The parameter of interest was the indirect effect at post||-2.22|-5.41|<0.001
73932879|NCT04154631|147395468|SUPERIORITY||Coefficient of indirect effect|0.07||||0.94|TWO_SIDED|95.0|-1.78|1.92|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||1.92|-1.78|0.94
73932880|NCT04154631|147395468|SUPERIORITY||Coefficient of indirect effect|0.05||||0.94|TWO_SIDED|95.0|-1.16|1.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||1.25|-1.16|0.94
73932881|NCT04154631|147395468|SUPERIORITY||Coefficient of indirect effect|0.03||||0.85|TWO_SIDED|95.0|-0.3|0.37|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.37|-0.30|0.85
73932882|NCT04154631|147395468|SUPERIORITY||Coefficient of indirect effect|-0.23||||0.7|TWO_SIDED|95.0|-1.41|0.95|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.95|-1.41|0.70
73932883|NCT04154631|147395468|SUPERIORITY||Coefficient of indirect effect|0.01||||0.92|TWO_SIDED|95.0|-0.23|0.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.25|-0.23|0.92
73932884|NCT04154631|147395468|SUPERIORITY||Coefficient of indirect effect|-0.07||||0.82|TWO_SIDED|95.0|-0.68|0.54|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.54|-0.68|0.82
74008280|NCT03627767|147566492|SUPERIORITY||Difference in percentage|41.3|||<|0.0001|TWO_SIDED|95.0|33.9|48.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.7|33.9|< 0.0001
74030357|NCT01052012|147614888|SUPERIORITY||Median Difference (Hodge-Lehmann)|-1.0||||0.9901|TWO_SIDED|95.0|-54.5|52.0|||Wilcoxon (Mann-Whitney)|||||52.0|-54.5|0.9901
73932885|NCT04154631|147395469|SUPERIORITY||Time by treatment interaction coeff.|-6.72|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in psychiatric symptoms from pre to post.||||<0.001
73932886|NCT04154631|147395469|SUPERIORITY||Coefficient of indirect effect|-1.86||||0.08|TWO_SIDED|95.0|-3.93|-0.21|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-0.21|-3.93|0.08
73932887|NCT04154631|147395469|SUPERIORITY||Coefficient of indirect effect|-2.51||||0.02|TWO_SIDED|95.0|-4.58|-0.44|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep-related impairment (PROMIS-SRI) at post. The parameter of interest was the indirect effect.||-0.44|-4.58|0.02
73932888|NCT04154631|147395469|SUPERIORITY||Coefficient of indirect effect|0.05||||0.97|TWO_SIDED|95.0|-1.99|2.08|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.08|-1.99|0.97
73932889|NCT04154631|147395469|SUPERIORITY||Coefficient of indirect effect|0.004||||0.97|TWO_SIDED|95.0|-0.18|0.19|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||0.19|-0.18|0.97
73932890|NCT04154631|147395469|SUPERIORITY||Coefficient of indirect effect|0.02||||0.9|TWO_SIDED|95.0|-0.27|0.3|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.30|-0.27|0.90
73865155|NCT03495102|147276220|SUPERIORITY||Odds Ratio (OR)|1.49||||0.006|TWO_SIDED|95.0|1.12|1.98|||Regression, Logistic|||||1.98|1.12|0.006
73865156|NCT03495102|147276220|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.001|TWO_SIDED|95.0|1.65|3.01|||Regression, Logistic|||||3.01|1.65|<0.001
73865157|NCT03495102|147276221|SUPERIORITY||Mean Difference (Net)|-3.7||||0.084|TWO_SIDED|95.0|-7.8|0.5|||Mixed Models Analysis|||||0.5|-7.8|0.084
73865158|NCT03495102|147276221|SUPERIORITY||Mean Difference (Net)|-8.1|||<|0.001|TWO_SIDED|95.0|-12.3|-3.9|||Mixed Models Analysis|||||-3.9|-12.3|<0.001
73971691|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.401||||0.2002|TWO_SIDED|95.0|-0.213|1.016|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.016|-0.213|0.2002
73932891|NCT04154631|147395469|SUPERIORITY||Coefficient of indirect effect|0.01||||0.94|TWO_SIDED|95.0|-0.19|0.2|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.20|-0.19|0.94
73932892|NCT04154631|147395469|SUPERIORITY||Coefficient of indirect effect|-0.19||||0.8|TWO_SIDED|95.0|-1.67|1.28|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.28|-1.67|0.80
73932893|NCT04154631|147395469|SUPERIORITY||Coefficient of indirect effect|-0.04||||0.77|TWO_SIDED|95.0|-0.33|0.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.25|-0.33|0.77
73932894|NCT04154631|147395470|SUPERIORITY||time by treatment interaction coeff.|-0.01||||0.94|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Intervention Appropriateness Measure (IAM) from baseline (post-training) to post-treatment.||||0.94
73932895|NCT04154631|147395471|SUPERIORITY||Time by treatment interaction coeff.|-0.11||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Feasibility of Intervention Measure (FIM) from baseline (post-training) to post-treatment.||||0.34
73971692|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.29||||0.476|TWO_SIDED|95.0|-1.089|0.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.509|-1.089|0.4760
74008281|NCT03627767|147566492|SUPERIORITY||Difference in percentage|59.9|||<|0.0001|TWO_SIDED|95.0|53.1|66.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||66.7|53.1|< 0.0001
74030358|NCT01052012|147614888|SUPERIORITY||Median Difference (Hodge-Lehmann)|-5.0||||0.201|TWO_SIDED|95.0|-14.0|3.4|||Wilcoxon Rank-Sum|||||3.4|-14.0|0.2010
73865159|NCT04327024|147276238|OTHER||Mean Difference (Final Values)|-0.1||||0.862|TWO_SIDED|95.0|-1.28|1.08|||ANCOVA|Model included change from baseline as the dependent variable, treatment as the independent variable and baseline peak VO2 as covariate.||||1.08|-1.28|0.862
73865160|NCT04327024|147276239|OTHER||Mean Difference (Final Values)|0.44||||0.472|TWO_SIDED|95.0|-0.76|1.64|||ANCOVA|Model included change from baseline as the dependent variable, treatment as the independent variable and baseline peak VO2 as covariate.||||1.64|-0.76|0.472
73932896|NCT02138214|147395535|OTHER|||||||0.567||||||p-value threshold for statistical significance is 0.05|Fisher Exact|||||||0.567
73932897|NCT02138214|147395536|OTHER|||||||0.11|||||||t-test, 2 sided|||||||0.110
73932898|NCT02138214|147395538|OTHER|||||||0.758|||||||Fisher Exact|||||||0.758
73932899|NCT02138214|147395540|OTHER|||||||0.236|||||||Fisher Exact|||||||0.236
73932900|NCT02138214|147395541|OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
73932901|NCT02138214|147395542|OTHER|||||||0.4|||||||t-test, 2 sided|||||||0.400
73932902|NCT01196871|147395563|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|2.942|||||TWO_SIDED|90.0|2.439|3.548|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% confidence interval (CI) are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.548|2.439|
73932903|NCT01196871|147395563|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|2.942|||||TWO_SIDED|90.0|2.431|3.56|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.560|2.431|
73971693|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-0.699||||0.0914|TWO_SIDED|95.0|-1.512|0.113|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||0.113|-1.512|0.0914
73932904|NCT01196871|147395563|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|2.354|||||TWO_SIDED|90.0|1.826|3.035|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.035|1.826|
73932905|NCT01196871|147395563|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|2.375|||||TWO_SIDED|90.0|1.839|3.068|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.068|1.839|
73932906|NCT01196871|147395564|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.629|||||TWO_SIDED|90.0|1.44|1.843|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.843|1.440|
73932907|NCT01196871|147395564|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.546|||||TWO_SIDED|90.0|1.3|1.838|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.838|1.300|
73932908|NCT01196871|147395566|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.025|||||TWO_SIDED|90.0|0.921|1.14|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.140|0.921|
73932909|NCT01196871|147395566|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects mode Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.256|||||TWO_SIDED|90.0|1.026|1.538|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.538|1.026|
73932910|NCT01196871|147395568|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.034|||||TWO_SIDED|90.0|0.929|1.152|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.152|0.929|
74008282|NCT03627767|147566492|SUPERIORITY||Difference in percentage|18.7|||||TWO_SIDED|95.0|10.8|26.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.6|10.8|
74030359|NCT01052012|147614888|SUPERIORITY||Median Difference (Hodge-Lehmann)|-3.0||||0.5897|TWO_SIDED|95.0|-15.0|8.0|||Wilcoxon Rank-Sum|||||8.0|-15.0|0.5897
74030360|NCT00492401|147614900|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Expression levels of miR-29b in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests||||.02
74030361|NCT00492401|147614900|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Expression levels of DNMT3a in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests||||.06
73971694|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.328||||0.9705|TWO_SIDED|95.0|-1.122|1.777|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||1.777|-1.122|0.9705
73971695|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.977||||0.328|TWO_SIDED|95.0|-0.512|2.465|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.465|-0.512|0.3280
73971696|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.218||||0.9951|TWO_SIDED|95.0|-1.667|1.23|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||1.230|-1.667|0.9951
73971697|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.225||||0.1367|TWO_SIDED|95.0|-0.244|2.693|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.693|-0.244|0.1367
73971698|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.101||||0.0294|TWO_SIDED|95.0|0.111|2.091|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.091|0.111|0.0294
74008283|NCT03627767|147566492|SUPERIORITY||Difference in percentage|37.0|||<|0.0001|TWO_SIDED|95.0|29.6|44.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.4|29.6|< 0.0001
74008284|NCT03627767|147566492|SUPERIORITY||Difference in percentage|54.6|||<|0.0001|TWO_SIDED|95.0|47.6|61.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.7|47.6|< 0.0001
74008285|NCT03627767|147566492|SUPERIORITY||Difference in percentage|17.7|||||TWO_SIDED|95.0|9.4|26.0||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.0|9.4|
74008286|NCT03627767|147566492|SUPERIORITY||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|22.6|37.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.4|22.6|< 0.0001
74008287|NCT03627767|147566492|SUPERIORITY||Difference in percentage|50.9|||<|0.0001|TWO_SIDED|95.0|43.8|58.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.1|43.8|< 0.0001
73971699|NCT04800211|147483714|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-0.248||||0.6792|TWO_SIDED|95.0|-1.424|0.928|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||0.928|-1.424|0.6792
73971700|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.638||||0.4012|TWO_SIDED|95.0|-0.86|2.137|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||2.137|-0.860|0.4012
73971701|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.163||||0.0201|TWO_SIDED|95.0|0.343|3.983|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.983|0.343|0.0201
74091634|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.97|||||TWO_SIDED|95.0|1.16|3.34|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 17F||3.34|1.16|
73932911|NCT01196871|147395568|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.063|||||TWO_SIDED|90.0|0.972|1.164|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.164|0.972|
73932912|NCT01196871|147395570|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.059|||||TWO_SIDED|90.0|0.818|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.371|0.818|
73932913|NCT01196871|147395570|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|1.052|||||TWO_SIDED|90.0|0.807|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.371|0.807|
73932914|NCT01196871|147395571|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|0.997|||||TWO_SIDED|90.0|0.791|1.259|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.259|0.791|
73932915|NCT03062891|147395586|SUPERIORITY||Slope|0.54||||0.572|TWO_SIDED|95.0|-1.33|2.4|||Regression, Linear|||This analysis looked at the interaction between baseline anxiety symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.40|-1.33|.572
73932916|NCT03062891|147395587|SUPERIORITY||Slope|0.08||||0.934|TWO_SIDED|95.0|-1.82|1.98|||Regression, Linear|||This analysis looked at the interaction between baseline depression symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.98|-1.82|.934
73932917|NCT03062891|147395588|SUPERIORITY||Slope|1.07||||0.253|TWO_SIDED|95.0|-0.76|2.89|||Regression, Linear|||This analysis looked at the interaction between attentional problems and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.89|-0.76|.253
73971702|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.21||||0.1709|TWO_SIDED|95.0|-0.528|2.948|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||2.948|-0.528|0.1709
73865161|NCT04327024|147276240|OTHER||Mean Difference (Final Values)|3.15||||0.287|TWO_SIDED|95.0|-2.65|8.94|||Mixed Models Analysis|Model included treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS as covariates.||"H0: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs placebo) = 0 Ha: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs placebo) ≠ 0~A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level."||8.94|-2.65|0.287
73932918|NCT03062891|147395589|SUPERIORITY||Slope|1.2||||0.215|TWO_SIDED|95.0|-0.7|3.1|||Regression, Linear|||This analysis looked at the interaction between baseline paranois and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.10|-0.70|.215
73932919|NCT03062891|147395589|SUPERIORITY||Slope|1.14||||0.254|TWO_SIDED|95.0|-0.83|3.11|||Regression, Linear|||This analysis looked at the interaction between baseline hallucinations and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.11|-0.83|.254
73865162|NCT04327024|147276241|OTHER||Mean Difference (Final Values)|-0.15||||0.96|TWO_SIDED|95.0|-5.9|5.61|||Mixed Models Analysis|Model included treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS as covariates.||"H0: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs allopurinol) = 0 Ha: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs allopurinol) ≠ 0~A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level."||5.61|-5.90|0.960
73865163|NCT01192568|147276244|SUPERIORITY||Mean Difference (Final Values)|14.22|STANDARD_ERROR_OF_MEAN|4.612||0.0928|TWO_SIDED|95.0|-2.45|30.9|||ANCOVA|||||30.90|-2.45|0.0928
73932920|NCT03062891|147395589|SUPERIORITY||Slope|-0.27||||0.778|TWO_SIDED|95.0|-2.13|1.59|||Regression, Linear|||This analysis looked at the interaction between baseline cognitive disorganization and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.59|-2.13|.778
73932921|NCT03062891|147395590|SUPERIORITY||Slope|-0.25||||0.8|TWO_SIDED|95.0|-2.16|1.67|||Regression, Linear|||This analysis looked at the interaction between baseline positive mental health and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.67|-2.16|.800
73932922|NCT03062891|147395591|SUPERIORITY||Slope|0.59||||0.525|TWO_SIDED|95.0|-1.25|2.44|||Regression, Linear|||This analysis looked at the interaction between baseline perceived stress and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.44|-1.25|.525
73932923|NCT03062891|147395592|SUPERIORITY||Slope|1.3||||0.14|TWO_SIDED|95.0|-0.43|3.03|||Regression, Linear|||This analysis looked at the interaction between baseline threatening life events and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.03|-0.43|.140
73932924|NCT03062891|147395593|SUPERIORITY||Slope|-2.58||||0.03|TWO_SIDED|95.0|-4.9|-0.25|||Generalized estimating equation|||This analysis looked at the effect of group on changes in anxiety symptoms across the intervention period.||-0.25|-4.90|.030
73932925|NCT03062891|147395594|SUPERIORITY||Slope|-0.63||||0.456|TWO_SIDED|95.0|-2.24|1.01|||Generalized estimating equation|||This analysis looked at the effect of group on changes in depression symptoms across the intervention period.||1.01|-2.24|.456
73932926|NCT03062891|147395595|SUPERIORITY||Slope|-2.34||||0.11|TWO_SIDED|95.0|-5.21|0.53|||Generalized estimating equation|||This analysis looked at the effect of group on changes attentional problems across the intervention period.||0.53|-5.21|.110
73932927|NCT03062891|147395596|SUPERIORITY||Slope|-1.69||||0.041|TWO_SIDED|95.0|-3.31|-0.07|||Generalized estimating equations|||This analysis looked at the effect of group on changes in psychotic experiences (paranoia) across the intervention period.||-0.07|-3.31|.041
73932928|NCT03062891|147395596|SUPERIORITY||Slope|-0.22||||0.531|TWO_SIDED|95.0|-0.92|0.48|||Generalized estimating equation|||This analysis looked at the effect of group on changes in psychotic experiences (hallucinations) across the intervention period.||0.48|-0.92|.531
73932929|NCT03062891|147395596|SUPERIORITY||Slope|-0.37||||0.13|TWO_SIDED|95.0|-0.84|0.11|||Generalized estimating equation|||This analysis looked at the effect of group on changes in psychotic experiences (cognitive disorganization) across the intervention period.||0.11|-0.84|.130
73932930|NCT03062891|147395597|SUPERIORITY||Slope|0.07||||0.916|TWO_SIDED|95.0|-1.17|1.3|||Generalized estimating equation|||This analysis looked at the effect of group on changes in positive mental health across the intervention period.||1.30|-1.17|.916
73932931|NCT03062891|147395598|SUPERIORITY||Slope|-2.03||||0.027|TWO_SIDED|95.0|-3.83|-0.23|||Generalized estimating equation|||This analysis looked at the effect of group on changes in perceived stress across the intervention period.||-0.23|-3.83|.027
73932932|NCT03062891|147395600|SUPERIORITY||Odds Ratio (OR)|1.36||||0.296|TWO_SIDED|95.0|0.77|2.4|||Regression, Logistic|||Assocation between baseline anxiety symptoms and exploding head syndrome||2.40|0.77|.296
73932933|NCT03062891|147395600|SUPERIORITY||Odds Ratio (OR)|0.69||||0.065|TWO_SIDED|95.0|0.47|1.02|||Regression, Logistic|||Assocation between baseline insomnia symptoms and exploding head syndrome||1.02|0.47|.065
73932934|NCT03062891|147395600|SUPERIORITY||Odds Ratio (OR)|0.67||||0.145|TWO_SIDED|95.0|0.39|1.15|||Regression, Logistic|||Assocation between baseline depression symptoms and exploding head syndrome||1.15|0.39|.145
73932935|NCT03062891|147395600|SUPERIORITY||Odds Ratio (OR)|1.26||||0.398|TWO_SIDED|95.0|0.73|2.19|||Regression, Logistic|||Assocation between baseline life stress and exploding head syndrome||2.19|0.73|.398
73932936|NCT03062891|147395600|SUPERIORITY||Odds Ratio (OR)|1.72||||0.001|TWO_SIDED|95.0|1.24|2.38|||Regression, Logistic|||Assocation between sleep paralysis and exploding head syndrome||2.38|1.24|.001
73932937|NCT02127307|147395601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.446|||<|0.0001|TWO_SIDED|95.0|0.3227|0.6156||At 0.025 level of significance.|Cox proportional hazards model|||"AdreView-Heart Failure Group with H/M \<1.60 vs. H/M ≥1.60:~Data analysis was performed using Cox proportional hazards model to demonstrate the relationship of consensus numeric H/M ratio and time to adverse cardiac events to identify participants with higher risk of death. Hazard (risk) of a death for a participant with H/M ratio at time t was expressed as Hl (t)/Hh (t)=Ψ,where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.6156|0.3227|<0.0001
73932938|NCT03509948|147395602|SUPERIORITY||Geometric Least Squares Mean|79.57|||||TWO_SIDED|90.0|66.4|95.35||||||Fed/Fasted Ratio||95.35|66.40|
73932939|NCT03509948|147395603|SUPERIORITY||Geometric Least Squares Mean|92.08|||||TWO_SIDED|90.0|88.37|95.95||||||Fed/Fasted Ratio||95.95|88.37|
73932940|NCT03509948|147395604|SUPERIORITY||Geometric Least Squares Mean|90.89|||||TWO_SIDED|90.0|84.99|97.2||||||Fed/Fasted Ratio||97.20|84.99|
73932941|NCT03509948|147395606|SUPERIORITY||Geometric Least Squares Mean|1.0|||||TWO_SIDED|90.0|0.25|1.75||||||Fed/Fasted Ratio||1.75|0.25|
73971703|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.593||||0.0307|TWO_SIDED|95.0|0.15|3.035|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.035|0.150|0.0307
74008288|NCT03627767|147566492|SUPERIORITY||Difference in percentage|21.1|||||TWO_SIDED|95.0|12.8|29.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.5|12.8|
73932942|NCT03509948|147395608|SUPERIORITY||Geometric Least Squares Mean|91.4|||||TWO_SIDED|90.0|87.55|95.41||||||Fed/Fasted Ratio||95.41|87.55|
73932943|NCT03221257|147395611|SUPERIORITY||Mean Difference (Net)|-0.14||||0.9326|TWO_SIDED||||||Mixed Models Analysis|||||||0.9326
73932944|NCT03221257|147395612|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9968|TWO_SIDED||||||Mixed Models Analysis|||||||0.9968
73932945|NCT03221257|147395613|SUPERIORITY||Mean Difference (Net)|0.46||||0.7489|TWO_SIDED||||||Mixed Models Analysis|||||||0.7489
73932946|NCT03221257|147395614|SUPERIORITY||Mean Difference (Net)|-9.2||||0.8898|TWO_SIDED||||||Mixed Models Analysis|||||||0.8898
73932947|NCT03221257|147395615|SUPERIORITY||Mean Difference (Net)|0.86||||0.3826|TWO_SIDED||||||Mixed Models Analysis|||||||0.3826
73932948|NCT03221257|147395616|SUPERIORITY||Mean Difference (Net)|-0.14||||0.2819|TWO_SIDED||||||Mixed Models Analysis|||||||0.2819
73932949|NCT03221257|147395617|SUPERIORITY||Mean Difference (Net)|-1.35||||0.7534|TWO_SIDED||||||Mixed Models Analysis|||||||0.7534
73932950|NCT03221257|147395618|SUPERIORITY||Mean Difference (Net)|-1.58||||0.1701|TWO_SIDED||||||ANCOVA|||||||0.1701
73932951|NCT03221257|147395619|SUPERIORITY||Mean Difference (Net)|-2.44||||0.3515|TWO_SIDED||||||ANCOVA|||||||0.3515
73932952|NCT03221257|147395620|SUPERIORITY||Mean Difference (Net)|-3.51||||0.1177|TWO_SIDED||||||ANCOVA|||||||0.1177
73932953|NCT03221257|147395621|SUPERIORITY||Mean Difference (Net)|-3.98||||0.1931|TWO_SIDED||||||ANCOVA|||||||0.1931
73932954|NCT03221257|147395622|SUPERIORITY||Mean Difference (Net)|121.3||||0.1811|TWO_SIDED||||||ANCOVA|||||||0.1811
73932955|NCT03221257|147395623|SUPERIORITY||Hazard Ratio (HR)|1.433||||0.3261|TWO_SIDED||||||Stratified log rank|||||||0.3261
73932956|NCT03221257|147395624|SUPERIORITY||Odds Ratio (OR)|1.6||||0.454|TWO_SIDED||||||Regression, Logistic|||||||0.454
73932957|NCT01129141|147395639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.198|STANDARD_ERROR_OF_MEAN|2.88|<|0.0001|TWO_SIDED|95.0|-22.86|-11.53|||Mixed Models Analysis|||||-11.53|-22.86|<.0001
73932958|NCT02755831|147395653|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Fisher's Exact Test||||<0.05
73932959|NCT02755831|147395654|OTHER||||||<|0.05|||||||Friedman test|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.||||||<.05
73932960|NCT02755831|147395655|OTHER||||||<|0.05|||||||Friedman|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.||||||<0.05
73932961|NCT02755831|147395656|OTHER||||||<|0.05|||||||Friedman Test|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences in treatment group only.||||||<0.05
73932962|NCT02755831|147395657|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|T-test used to compare mean difference in hospital costs at time of delivery.||||||<0.05
73932963|NCT02442830|147395668|OTHER|Log rank test||||||0.002|||||||Log Rank|||||||.002
73865164|NCT01192568|147276245|SUPERIORITY||Mean Difference (Final Values)|34.92|STANDARD_ERROR_OF_MEAN|8.089||0.0054|TWO_SIDED|95.0|11.13|58.7|||ANCOVA|||||58.70|11.13|0.0054
73865165|NCT01192568|147276246|SUPERIORITY||Mean Difference (Final Values)|32.59|STANDARD_ERROR_OF_MEAN|13.215||0.1739|TWO_SIDED|95.0|-14.89|80.07|||ANCOVA|||||80.07|-14.89|0.1739
73865166|NCT01192568|147276247|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.117||0.266|TWO_SIDED|95.0|-0.53|0.15|||ANCOVA|||Results from a pre-specified test (Kolmogorov-Smirnov test p \<= 0.05) determined that the Pre-Am3 and Post-Am3 OTG data should be analyzed separately for the primary analysis.||0.15|-0.53|0.2660
73932964|NCT01516879|147395670|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.97|STANDARD_ERROR_OF_MEAN|2.1|<|0.001|TWO_SIDED|95.0|-61.08|-52.85|||Repeated measures linear effects model|The model included treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 52 in LDL-C between evolocumab 420 mg and placebo, and the alternative hypothesis was that a mean difference did exist.||-52.85|-61.08|<0.001
73932965|NCT01516879|147395671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.8|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-62.3|-53.3|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-53.3|-62.3|<0.001
73932966|NCT01516879|147395672|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|75.8|||<|0.001|TWO_SIDED|95.0|70.8|79.7|||Cochran-Mantel-Haenszel|CMH test stratified by the stratification factor. For testing, non-achievement was imputed for participants with a missing value at Week 52.|Treatment difference using placebo as the reference.|||79.7|70.8|<0.001
73932967|NCT01516879|147395673|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.51|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-60.57|-54.45|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-54.45|-60.57|<0.001
74030362|NCT01651260|147614910|SUPERIORITY_OR_OTHER||upper probability of failure|0.05||||||||||Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.|||Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.|||||
74030363|NCT02144220|147614913|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
74030364|NCT01417780|147614998|OTHER|||||||0.016|||||||ANOVA|||||||0.016
73865167|NCT01192568|147276247|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.007|TWO_SIDED|95.0|-1.13|-0.21|||t-test, 2 sided|||||-0.21|-1.13|0.0070
73865168|NCT02593825|147276248|SUPERIORITY|Significance was based on α = .05. Hedges' g, corrected for small sample bias, was calculated as a measure of effect size using the model-predicted group differences in rate of change in the numerator and the pooled standard deviation estimated from the 3 or 12 month assessment (for short- and long-term effects, respectively) in the denominator.|Slope|1.14|||<|0.05|TWO_SIDED|||||Piecewise linear mixed modeling (LMM) was performed to address the study questions. LMM was necessary to account for repeated measures nested within children.|Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5 Standard Deviations below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5 Standard Deviations below the mean on motor Bayley score at baseline)|Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months) and post-intervention (3 to 12 months) phases, and accounted for variation in the time between assessments across children. All models controlled for intercept-level differences by site, as well as intercept- and slope-level differences by baseline-adjusted age and motor severity. Intervention effects were derived via intervention by slope interaction terms. Three-way interaction terms were subsequently added to the models to obtain intervention effects stratified by severity.|||<0.05
73865169|NCT02593825|147276249|SUPERIORITY||Mean Difference (Final Values)|0.192||||0.05|TWO_SIDED||||||Linear piecewise modeling|||||||.05
73865170|NCT02593825|147276250|SUPERIORITY||Slope|0.92|STANDARD_ERROR_OF_MEAN|0.47|<|0.05|TWO_SIDED||||||Mixed Models Analysis||data shown is for the 12 month time point for the severely delayed group comparison|Also examined these groups in sub-groups of mildly delayed (\<2.5 Standard Deviations below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5 Standard Deviations below the mean on motor Bayley score at baseline)||||<0.05
73865171|NCT02593825|147276252|SUPERIORITY||Slope|1.02|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5SD below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5SD below the mean on motor Bayley score at baseline)|LMM was necessary to account for repeated measures nested within children. Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months).|||<0.05
73932968|NCT01516879|147395674|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.15|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-37.19|-33.11|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-33.11|-37.19|<0.001
73932969|NCT01516879|147395675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.45|STANDARD_ERROR_OF_MEAN|1.41|<|0.001|TWO_SIDED|95.0|-36.21|-30.68|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-30.68|-36.21|<0.001
74030365|NCT01417780|147614999|OTHER|||||||0.019|||||||Chi-squared|||The null hypothesis was that the frequency of Day 14 SOFA score less than or equal to 1 was not different among treatment groups.||||0.019
74030366|NCT01417780|147615000|OTHER|||||||0.11||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.11
74030367|NCT01417780|147615001|OTHER|||||||0.18||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.18
73865172|NCT02593825|147276253|SUPERIORITY||Slope|8.7|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5SD below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5SD below the mean on motor Bayley score at baseline)|Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months)|||<0.05
74091635|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.06|||||TWO_SIDED|95.0|1.21|3.51|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 17F||3.51|1.21|
73932970|NCT01516879|147395676|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.27|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-54.25|-46.28|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-46.28|-54.25|<0.001
73932971|NCT01516879|147395677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.21|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-47.56|-40.85|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-40.85|-47.56|<0.001
73932972|NCT01516879|147395678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.14|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|-40.41|-33.87|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-33.87|-40.41|<0.001
73932973|NCT01516879|147395679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.21|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-49.79|-42.63|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-42.63|-49.79|<0.001
73932974|NCT01516879|147395680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.35|STANDARD_ERROR_OF_MEAN|1.94|<|0.001|TWO_SIDED|95.0|-26.15|-18.55|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-18.55|-26.15|<0.001
73932975|NCT01516879|147395681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-11.54|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-17.21|-5.86|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-5.86|-17.21|<0.001
73932976|NCT01516879|147395682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.42|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|3.28|7.56|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||7.56|3.28|<0.001
73932977|NCT01516879|147395683|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.15|STANDARD_ERROR_OF_MEAN|5.64|<|0.001|TWO_SIDED|95.0|-40.23|-18.08|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-18.08|-40.23|<0.001
73932978|NCT01516879|147395684|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.14|STANDARD_ERROR_OF_MEAN|1.84||0.94|TWO_SIDED|95.0|-3.76|3.48|||ANCOVA|The ANCOVA model includes treatment group and stratification factor as covariates.|Treatment difference using placebo as the reference.|||3.48|-3.76|0.94
73932979|NCT01720069|147395687|SUPERIORITY|||||||0.772|||||||ANCOVA|||||||0.772
73932980|NCT01720069|147395688|SUPERIORITY|||||||0.891|||||||ANCOVA|||||||0.891
73932981|NCT01720069|147395689|SUPERIORITY|||||||0.066|||||||ANCOVA|||||||0.066
73932982|NCT01720069|147395690|SUPERIORITY|||||||0.063|||||||ANCOVA|||||||0.063
73932983|NCT01720069|147395691|SUPERIORITY|||||||0.054|||||||ANCOVA|||||||0.054
73932984|NCT01720069|147395692|SUPERIORITY|||||||0.168|||||||Fisher Exact|||||||0.168
73932985|NCT01720069|147395692|SUPERIORITY|||||||0.363|||||||Fisher Exact|||||||0.363
73932986|NCT01720069|147395692|SUPERIORITY|||||||0.805|||||||Fisher Exact|||||||0.805
73932987|NCT00508742|147395694|SUPERIORITY_OR_OTHER||Rate Ratio|0.56|||||TWO_SIDED|95.0|0.47|0.65||||||||0.65|0.47|
73932988|NCT00508742|147395695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.5|0.9||||||Month 7: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.9|0.5|
73932989|NCT00508742|147395695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.4|0.7||||||Month 12: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.7|0.4|
73932990|NCT00508742|147395695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.3|0.5||||||Month 13: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.5|0.3|
73932991|NCT00508742|147395695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.4|0.7||||||Month 18: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.7|0.4|
73932992|NCT00508742|147395695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.4|0.8||||||Month 24: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.8|0.4|
74030368|NCT01417780|147615002|OTHER|||||||0.19||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.19
74030369|NCT01345786|147615003|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|137.5||||||90.0|131.0|144.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||144.4|131|
74030370|NCT01345786|147615003|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|111.8||||||90.0|107.5|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||116.4|107.5|
73971704|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.588||||0.0691|TWO_SIDED|95.0|-0.126|3.302|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.302|-0.126|0.0691
73971705|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.487||||0.0034|TWO_SIDED|95.0|0.838|4.137|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.137|0.838|0.0034
73971706|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.849||||0.0034|TWO_SIDED|95.0|0.622|3.075|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.075|0.622|0.0034
73971707|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.178||||0.8123|TWO_SIDED|95.0|-1.654|1.299|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.299|-1.654|0.8123
73971708|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.48||||0.5879|TWO_SIDED|95.0|-2.226|1.267|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.267|-2.226|0.5879
74008289|NCT03627767|147566493|SUPERIORITY||Difference in percentage|1.4|||=|0.7232|TWO_SIDED|95.0|-6.1|8.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.8|-6.1|= 0.7232
74008290|NCT03627767|147566493|SUPERIORITY||Difference in percentage|-2.2|||=|0.5694|TWO_SIDED|95.0|-9.8|5.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.4|-9.8|= 0.5694
73865173|NCT02593825|147276254|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.417|TWO_SIDED||||||Mixed Models Analysis|||||||0.417
73865174|NCT01209078|147276282|SUPERIORITY_OR_OTHER||Difference|-22.2|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for end of therapy Clinical Success.||||
73865175|NCT01209078|147276282|SUPERIORITY_OR_OTHER||Difference|-24.0|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Follow-up Clinical Success.||||
73865176|NCT01209078|147276283|SUPERIORITY_OR_OTHER||Difference|-35.0|||||TWO_SIDED|95.0|-60.6|-9.4|||Regression, Logistic|||||-9.4|-60.6|
73865177|NCT01209078|147276284|SUPERIORITY_OR_OTHER||Difference|-35.0|||||TWO_SIDED|95.0|-60.6|-9.4|||Regression, Logistic|||||-9.4|-60.6|
73865178|NCT01209078|147276287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.41|0.74|||Mixed Models Analysis|||GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 exudate or pus score.||0.74|-0.41|
73865179|NCT01209078|147276287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.7|0.45|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 exudate or pus score.||0.45|-0.70|
73865180|NCT01209078|147276287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.74|0.43|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 exudate or pus score.||0.43|-0.74|
73865181|NCT01209078|147276287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||||TWO_SIDED|95.0|-0.25|0.95|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 exudate or pus score.||0.95|-0.25|
73865182|NCT01209078|147276287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.49|0.72|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 exudate or pus score.||0.72|-0.49|
73865183|NCT01209078|147276287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.53|0.66|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow- up exudate or pus score.||0.66|-0.53|
73932993|NCT02447991|147395718|SUPERIORITY||||||<|0.33||||||Significance level p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.33
73932994|NCT02447991|147395719|SUPERIORITY||||||<|0.18||||||Signficant at p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication||||<0.18
73932995|NCT02447991|147395720|SUPERIORITY||||||<|0.62||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.||||<0.62
73932996|NCT02447991|147395721|SUPERIORITY||||||<|0.19||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportions of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.||||<0.19
73865184|NCT01209078|147276287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.65|0.58|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow- up exudate or pus score.||0.58|-0.65|
73865185|NCT01209078|147276288|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|||||TWO_SIDED|95.0|-3.04|1.33|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.||1.33|-3.04|
73865186|NCT01209078|147276288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-2.94|1.41|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.||1.41|-2.94|
74008291|NCT03627767|147566493|SUPERIORITY||Difference in percentage|-3.7|||||TWO_SIDED|95.0|-11.2|3.8||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.8|-11.2|
73865187|NCT01209078|147276288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|||||TWO_SIDED|95.0|-1.68|2.75|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.||2.75|-1.68|
73865188|NCT01209078|147276288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-0.46|4.05|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.||4.05|-0.46|
73865189|NCT01209078|147276288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|-1.09|3.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.||3.47|-1.09|
73932997|NCT02447991|147395722|SUPERIORITY||||||<|0.14||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.14
74091636|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.77|1.91|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 20A||1.91|0.77|
73971709|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.596||||0.491|TWO_SIDED|95.0|-2.304|1.111|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.111|-2.304|0.4910
73971710|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.816||||0.9673|TWO_SIDED|95.0|-1.967|3.599|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.599|-1.967|0.9673
73971711|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.643||||0.1787|TWO_SIDED|95.0|-0.683|5.968|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.968|-0.683|0.1787
73971712|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.806||||0.5243|TWO_SIDED|95.0|-1.406|5.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.018|-1.406|0.5243
74008292|NCT03627767|147566493|SUPERIORITY||Difference in percentage|29.0|||<|0.0001|TWO_SIDED|95.0|22.2|35.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||35.8|22.2|< 0.0001
74008293|NCT03627767|147566493|SUPERIORITY||Difference in percentage|57.9|||<|0.0001|TWO_SIDED|95.0|51.2|64.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||64.5|51.2|< 0.0001
74030371|NCT01345786|147615004|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|107.3||||||90.0|99.0|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||116.4|99|
74030372|NCT01345786|147615004|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.6||||||90.0|99.2|108.2|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."|||108.2|99.2|
74030373|NCT01345786|147615005|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|110.0||||||90.0|106.4|113.7|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUClast||113.7|106.4|
74030374|NCT01345786|147615005|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.3||||||90.0|100.9|105.7|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC last||105.7|100.9|
73971713|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.77||||0.3956|TWO_SIDED|95.0|-0.966|4.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.507|-0.966|0.3956
73971714|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.068||||0.381|TWO_SIDED|95.0|-1.16|5.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.295|-1.160|0.3810
73971715|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|3.084||||0.0557|TWO_SIDED|95.0|-0.049|6.216|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||6.216|-0.049|0.0557
73971716|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.445||||0.0195|TWO_SIDED|95.0|0.4|4.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.490|0.400|0.0195
73971717|NCT04800211|147483715|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.277||||0.2817|TWO_SIDED|95.0|-3.615|1.06|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.060|-3.615|0.2817
73971718|NCT05170841|147483716|SUPERIORITY||||||=|0.566|||||||t-test, 2 sided|||||||=0.566
73971719|NCT05170841|147483717|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
73971720|NCT05170841|147483718|SUPERIORITY||||||=|0.006|||||||t-test, 2 sided|||||||=0.006
74088786|NCT03135899|147730611|OTHER||Geometric Mean Ratio|0.926|STANDARD_ERROR_OF_MEAN|1.168|||TWO_SIDED|90.0|0.715|1.199|||Mixed Models Analysis||BI 443651 400 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||1.199|0.715|
74091637|NCT04168190|147737018|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.56|||||TWO_SIDED|95.0|0.99|2.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 20A||2.45|0.99|
73932998|NCT02447991|147395723|SUPERIORITY||||||<|0.72||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.72
73932999|NCT02447991|147395724|SUPERIORITY||||||<|0.48||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.48
73971721|NCT05170841|147483719|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
73971722|NCT05170841|147483720|SUPERIORITY||||||=|0.031|||||||t-test, 2 sided|||||||=0.031
73933000|NCT02447991|147395725|SUPERIORITY||||||<|0.35||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication..||||<0.35
73933001|NCT02447991|147395726|SUPERIORITY||||||<|0.022||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with effectiveness of study medication||||<0.022
73933002|NCT02447991|147395726|SUPERIORITY||||||<|0.418||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with side effects of study medication||||<0.418
73933003|NCT02447991|147395726|SUPERIORITY||||||<|0.674||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with convenience of study medication||||<0.674
73933004|NCT02447991|147395726|SUPERIORITY||||||<|0.016||||||Significance of threshold of p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with overall satisfaction of study medication||||<0.016
73933005|NCT02447991|147395727|SUPERIORITY||||||<|0.009||||||Significance threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on physical well-being||||<0.009
73933006|NCT02447991|147395727|SUPERIORITY||||||<|0.467||||||Significance threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on mental well-being||||<0.467
73933007|NCT02447991|147395728|SUPERIORITY||||||<|0.013||||||Significance threshold p\<0.05|Logistic regression with GEE|GEE=generalized estimating equations - this accounts for repeated measures within patients.This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to fatigue.||||<0.013
73933008|NCT02447991|147395728|SUPERIORITY||||||<|0.021||||||Significance threshold p\<0.05|Logistic regression with GEE|GEE=generalized estimating equations - this accounts for repeated measures within patients. This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to sleepiness/drowsiness||||<0.021
73933009|NCT02447991|147395729|SUPERIORITY||||||<|0.76||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.76
73933010|NCT02447991|147395730|SUPERIORITY||||||<|0.041||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness episodes measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.041
73933011|NCT02447991|147395731|SUPERIORITY||||||<|0.12||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.12
74030375|NCT01345786|147615005|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|108.1||||||90.0|104.7|111.6|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUC infinity||111.6|104.7|
74030376|NCT01345786|147615005|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.1||||||90.0|100.5|105.8|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC infinity||105.8|100.5|
73971723|NCT05170841|147483721|SUPERIORITY||||||=|0.027|||||||t-test, 2 sided|||||||=0.027
73971724|NCT05170841|147483722|SUPERIORITY||||||=|0.011|||||||t-test, 2 sided|||||||=0.011
73971725|NCT05170841|147483723|SUPERIORITY||||||=|0.007|||||||t-test, 2 sided|||||||=0.007
73971726|NCT05170841|147483724|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
73971727|NCT05170841|147483725|SUPERIORITY||||||=|0.029|||||||t-test, 2 sided|||||||=0.029
73971728|NCT05170841|147483726|SUPERIORITY||||||=|0.022|||||||t-test, 2 sided|||||||=0.022
73971729|NCT05170841|147483727|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73971730|NCT05170841|147483728|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73971731|NCT05170841|147483729|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||||||=0.001
73971732|NCT05170841|147483730|SUPERIORITY||||||=|0.01|||||||t-test, 2 sided|||||||=0.01
73971733|NCT05170841|147483731|SUPERIORITY||||||=|0.04|||||||t-test, 2 sided|||||||=0.04
73971734|NCT05170841|147483732|SUPERIORITY||||||=|0.016|||||||t-test, 2 sided|||||||=0.016
73971735|NCT05170841|147483733|SUPERIORITY||||||=|0.045|||||||t-test, 2 sided|||||||=0.045
73865190|NCT01209078|147276288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||||TWO_SIDED|95.0|-1.49|2.98|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.||2.98|-1.49|
73933012|NCT02447991|147395732|SUPERIORITY||||||<|0.051||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.051
73933013|NCT02447991|147395733|SUPERIORITY||||||<|0.006||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.006
73971736|NCT05170841|147483734|SUPERIORITY||||||=|0.042|||||||t-test, 2 sided|||||||=0.042
73971737|NCT05170841|147483735|SUPERIORITY||||||=|0.037|||||||t-test, 2 sided|||||||=0.037
73971738|NCT05170841|147483736|SUPERIORITY||||||=|0.045|||||||t-test, 2 sided|||||||=0.045
73971739|NCT05170841|147483737|SUPERIORITY||||||=|0.029|||||||t-test, 2 sided|||||||=0.029
73971740|NCT05170841|147483738|SUPERIORITY||||||=|0.027|||||||t-test, 2 sided|||||||=0.027
73971741|NCT05170841|147483739|SUPERIORITY||||||=|0.035|||||||t-test, 2 sided|||||||=0.035
74030377|NCT01345786|147615006|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.5||||||90.0|96.7|106.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||106.4|96.7|
73865191|NCT01209078|147276288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|-2.09|2.52|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.||2.52|-2.09|
73865192|NCT01209078|147276289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|||||TWO_SIDED|95.0|-3.04|1.33|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.||1.33|-3.04|
73865193|NCT01209078|147276289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-2.94|1.41|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.||1.41|-2.94|
73971742|NCT05170841|147483740|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||||||=0.001
73971743|NCT03806790|147483742|SUPERIORITY||Odds Ratio (OR)|5.8||||0.12|TWO_SIDED|95.0|0.68|49.16|||Fisher Exact|||Statistical analysis on the Full Analysis Set (FAS)||49.16|0.68|0.120
73971744|NCT03806790|147483743|SUPERIORITY||Odds Ratio (OR)|2.5||||0.004|TWO_SIDED|95.0|1.36|4.6|||Fisher Exact|||End of Week 1 (FAS)||4.60|1.36|0.004
73971745|NCT03806790|147483743|SUPERIORITY||Odds Ratio (OR)|4.85||||0.003|TWO_SIDED|95.0|1.57|14.97|||Fisher Exact|||End of Week 2 (FAS)||14.97|1.57|0.003
73971746|NCT03806790|147483744|SUPERIORITY||Estimated difference|-1.11|||<|0.001|TWO_SIDED|95.0|-1.64|-0.59|||ANOVA|||FAS||-0.59|-1.64|<0.001
73971747|NCT06122194|147483794|OTHER||Ratio of Adjusted Geometric Means|112.15|||||TWO_SIDED|90.0|93.01|135.22||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90 percent (%) confidence intervals (CIs) were expressed as percentages.||135.22|93.01|
73971748|NCT06122194|147483794|OTHER||Ratio of Adjusted Geometric Means|187.37|||||TWO_SIDED|90.0|155.79|225.35||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||225.35|155.79|
73971749|NCT06122194|147483794|OTHER||Ratio of Adjusted Geometric Means|153.61|||||TWO_SIDED|90.0|127.4|185.21||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||185.21|127.40|
73971750|NCT06122194|147483795|OTHER||Ratio of Adjusted Geometric Means|102.59|||||TWO_SIDED|90.0|91.09|115.54||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||115.54|91.09|
73971751|NCT06122194|147483795|OTHER||Ratio of Adjusted Geometric Means|125.07|||||TWO_SIDED|90.0|110.81|141.17||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||141.17|110.81|
73971752|NCT06122194|147483795|OTHER||Ratio of Adjusted Geometric Means|121.75|||||TWO_SIDED|90.0|108.65|136.43||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||136.43|108.65|
73971753|NCT02709161|147483816|SUPERIORITY||Mean Difference (Final Values)|8.2|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
73971754|NCT02709161|147483817|SUPERIORITY||Mean Difference (Final Values)|8.2|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
73971755|NCT05671653|147483828|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.85|||||TWO_SIDED|90.0|80.25|98.38||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).||98.38|80.25|
74091638|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|13.98|||||TWO_SIDED|95.0|5.9|33.1|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 6A||33.10|5.90|
73865194|NCT01209078|147276289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54|||||TWO_SIDED|95.0|-1.68|2.75|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.||2.75|-1.68|
73933014|NCT02447991|147395734|SUPERIORITY||||||<|0.67||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.67
73933015|NCT00459134|147395735|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|1.19||0.576|TWO_SIDED|95.0|-1.67|3.0||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis is that sexual function will be the same in both groups at 12 weeks. A Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.||3.00|-1.67|0.576
73865195|NCT01209078|147276289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.79|||||TWO_SIDED|95.0|-0.46|4.05|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.||4.05|-0.46|
73933016|NCT00459134|147395736|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.49|STANDARD_ERROR_OF_MEAN|1.73||0.01|TWO_SIDED|95.0|1.09|7.89||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis was that quality of life would be the same in both groups at 12 weeks. A mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.||7.89|1.09|0.010
73933017|NCT00829621|147395737|SUPERIORITY_OR_OTHER||||||=|0.36|||||||t-test, 1 sided|||||||=0.36
73933018|NCT06748040|147395779|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4852|TWO_SIDED|95.0|-2.4|1.2||P-value less than 0.05 is considered as statistically significant.|t-test, 2 sided|||||1.2|-2.4|0.4852
73933019|NCT00320281|147395782|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||ANCOVA|||||||0.432
73933020|NCT00827372|147395784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0658|||||||t-test, 2 sided|||With a sample size of 14 evaluable subjects, we will have 80% power to detect a change in excess arm volume of .8 standard deviations using a two-sided paired t-test. We will have 90% power to detect a difference of .9 standard deviations. A Paired T-Test was used to test the difference in arm volume from the second baseline measurement to Cycle 2 only.||||0.0658
73971756|NCT05671653|147483828|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|70.0|||||TWO_SIDED|90.0|55.21|88.76||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).||88.76|55.21|
73971757|NCT05671653|147483829|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|57.19|||||TWO_SIDED|90.0|39.27|83.29||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).||83.29|39.27|
74088787|NCT03135899|147730611|OTHER||Geometric Mean Ratio|0.845|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|90.0|0.651|1.095|||Mixed Models Analysis||BI 443651 1200 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||1.095|0.651|
74091639|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|14.42|||||TWO_SIDED|95.0|6.05|34.35|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 6A||34.35|6.05|
73933021|NCT00827372|147395785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||t-test, 2 sided|||A Paired T-Test was used to compare the IFP affected at first versus affected at last reading.||||0.0061
73933022|NCT00827372|147395786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0143|||||||t-test, 2 sided|||A Paired T-Test was used for the difference in the impedance ratio from the second baseline to cycle 2, day 1||||0.0143
73933023|NCT03143829|147395833|OTHER|||||||0.083|||||||t-test, 2 sided|||Differences at week 10||||0.083
73933024|NCT03143829|147395834|OTHER|||||||0.099|||||||t-test, 2 sided|||Descriptive comparison||||.099
73933025|NCT03143829|147395835|OTHER|||||||0.558|||||||t-test, 2 sided|||comparison at time 4||||.558
73933026|NCT03143829|147395836|OTHER|||||||0.153|||||||Chi-squared|||descriptive comparison of resource use||||.153
73933027|NCT00672477|147395839|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||< 0.0001
73933028|NCT00672477|147395840|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||< 0.0001
73933029|NCT02348489|147395842|SUPERIORITY||Difference in response rate (%)|1.92||||0.482|TWO_SIDED|96.0|-3.67|7.5|||Cochran-Mantel-Haenszel|||The complete response rate was compared between the treatment groups using a Cochran Mantel-Haenszel (CMH) test at an alpha level of 0.04 stratified to adjust for stratification factors used at randomization: age (\<75 or \>=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).||7.5|-3.67|0.482
74008294|NCT03627767|147566493|SUPERIORITY||Difference in percentage|28.9|||||TWO_SIDED|95.0|20.8|37.0||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.0|20.8|
73865196|NCT01209078|147276289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19|||||TWO_SIDED|95.0|-1.09|3.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.||3.47|-1.09|
73865197|NCT01209078|147276289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|-1.49|2.98|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.||2.98|-1.49|
73865198|NCT01209078|147276289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-2.09|2.52|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.||2.52|-2.09|
73865199|NCT01209078|147276290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.85|||||TWO_SIDED|95.0|-132.8|-4.95|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 wound area.||-4.95|-132.8|
73865200|NCT01209078|147276290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.06|||||TWO_SIDED|95.0|-66.54|60.43|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 wound area.||60.43|-66.54|
73865201|NCT01209078|147276290|SUPERIORITY_OR_OTHER||Median Difference (Net)|31.47|||||TWO_SIDED|95.0|-33.53|96.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 wound area.||96.47|-33.53|
73865202|NCT01209078|147276290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.94|||||TWO_SIDED|95.0|-22.43|110.31|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 wound area.||110.31|-22.43|
73933030|NCT02348489|147395843|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7328|TWO_SIDED|95.0|0.83|1.14|||Stratified log-rank|||Overall survival curves were estimated using Kaplan-Meier method and compared between the treatment groups using a 2-sided stratification log-rank test, stratified by the same factors used at randomization: age (\<75 or \>=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).||1.14|0.83|0.7328
73865203|NCT01209078|147276290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.21|||||TWO_SIDED|95.0|-33.03|101.45|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 wound area.||101.45|-33.03|
73865204|NCT01209078|147276290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.57|||||TWO_SIDED|95.0|-28.25|103.4|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up wound area.||103.40|-28.25|
73865205|NCT01209078|147276290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.4|||||TWO_SIDED|95.0|-30.77|105.56|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up wound area.||105.56|-30.77|
73865206|NCT01209078|147276291|SUPERIORITY_OR_OTHER||Difference|-35.4|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Staphylococcus aureus (all).||||
73865207|NCT01209078|147276291|SUPERIORITY_OR_OTHER||Difference|-37.5|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for MRSA.||||
73865208|NCT01209078|147276291|SUPERIORITY_OR_OTHER||Difference|-28.6|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for MSSA.||||
73865209|NCT01209078|147276291|SUPERIORITY_OR_OTHER||Difference|-66.7|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Streptococcus pyogenes.||||
73865210|NCT01209078|147276291|SUPERIORITY_OR_OTHER||Difference|-25.0|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Gram-negative pathogens.||||
73933031|NCT01176591|147395862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.08
73865211|NCT01209078|147276291|SUPERIORITY_OR_OTHER||Difference|-37.5|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for All pathogens.||||
73865212|NCT01209078|147276291|SUPERIORITY_OR_OTHER||Difference|2.2|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for No pathogens.||||
73865213|NCT00924508|147276293|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
73865214|NCT00924508|147276293|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
73865215|NCT00924508|147276293|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
73865216|NCT00511134|147276301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Descriptive data|||It was hypothesized that the Zyban+Lunesta group would report lower ISI scores at end of trial than the Zyban+Placebo group.||||<0.05
73865217|NCT00511134|147276302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Fisher Exact|Degrees of freedom=1||It is predicted that subjects taking eszopiclone will be more likely to report abstinence at trial endpoint than those taking placebo.||||<0.05
73865218|NCT03055013|147276350|SUPERIORITY||Cox Proportional Hazard|0.95||||0.34|TWO_SIDED|95.0|0.74|1.22|||Log Rank|stratified logrank test (one-sided)|hazard ratio : arm A vs. arm B|||1.22|0.74|0.34
73865219|NCT00528801|147276362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.07||0.008||95.0|||||Mixed Models Analysis|Adjusted for gender, age, and education.|Cases are lower than controls.|Null hypothesis is no difference between cases and controls in the WAIS-III Perormance IQ (PIQ) Index. A linear model controlling for gender, age, and education was used to compare controls versus cases using an F statistic. Based on sample-size calculations, 120 patients and 36 controls were needed to have 80% power to detect an 8-point difference on the WAIS-III PIQ Index.||||0.008
73865220|NCT00528801|147276363|SUPERIORITY_OR_OTHER||Difference in proportions|0.11||||0.048||95.0|0.026|0.199|||Fisher Exact|||Null hypothesis is no difference between cases and controls in the proportion of subjects with lacunae. This was tested using a Fisher's Exact Test.||.199|.026|0.048
73865221|NCT00344500|147276365|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Predicted trajectory of mean weight change between matched UC and LB subjects over 12 months (treatment\*time interaction: F(1,1275)=68.75, p\<.01).||General Linear Mixed Model (GLMM) used to illustrate the magnitude of difference between slopes for major outcomes for two hypothetical participants with identical baseline characteristics over 12 months.||||<0.01
73933032|NCT01176591|147395863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.08
73933033|NCT01176591|147395864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046|||||||t-test, 2 sided|||||||0.046
73933034|NCT01176591|147395865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||t-test, 2 sided|||||||0.039
73933035|NCT01176591|147395867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||t-test, 2 sided|||||||0.035
73933036|NCT00408993|147395868|SUPERIORITY_OR_OTHER|||||||0.617||95.0||||Treatment effects were evaluated based on a two-sided significance level of 0.05 and interaction effects at 0.10. No adjustments for multiple comparisons were made.|ANCOVA|Model=Treatment, Pooled Investigator and Baseline.||With 104 patients per arm, the study has at least 85% power to detect a treatment group difference of -1.20 points in baseline to endpoint mean change on the BPI 24-hour average pain score between Duloxetine and Placebo. Sample size determined using a two-sided t-test with alpha=0.05, and assuming a common standard deviation of 2.5 and a discontinuation rate of 25%.||||0.617
73933037|NCT00408993|147395869|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||P-value for Worst Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.070
73971758|NCT05671653|147483829|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|29.68|||||TWO_SIDED|90.0|19.6|44.94||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).||44.94|19.60|
73971759|NCT05671653|147483830|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|119.86|||||TWO_SIDED|90.0|108.97|131.85||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 5).||131.85|108.97|
74091640|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|7.39||||||95.0|4.29|12.75|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15A||12.75|4.29|
73933038|NCT00408993|147395869|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value for Least Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.151
73933039|NCT00408993|147395869|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Pain Right Now Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.012
73933040|NCT00408993|147395869|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||P-value for Average Interference Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.077
73933041|NCT00408993|147395870|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.036
73933042|NCT00408993|147395871|SUPERIORITY_OR_OTHER|||||||0.955||95.0||||P-value for Visit 3|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.955
73933043|NCT00408993|147395871|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Visit 4|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.004
73933044|NCT00408993|147395871|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Visit 5|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.037
73933045|NCT00408993|147395871|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Visit 6|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||<0.001
73933046|NCT00408993|147395871|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-value for Visit 7|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.028
73933047|NCT00408993|147395872|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.207
73933048|NCT00408993|147395873|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Fisher Exact|||||||0.008
73933049|NCT00408993|147395875|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value for 5-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.364
73933050|NCT00408993|147395875|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value for 8-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.590
73933051|NCT00408993|147395876|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|Model=Treatment and Pooled Investigator||||||0.620
73933052|NCT00408993|147395877|SUPERIORITY_OR_OTHER|||||||0.324||95.0|||||ANOVA|Model=Treatment and Pooled Investigator||||||0.324
73933053|NCT00408993|147395878|SUPERIORITY_OR_OTHER|||||||0.642||95.0||||P-value for Systolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator||||||0.642
73933054|NCT00408993|147395878|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||P-value for Diastolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator||||||0.601
73933055|NCT00408993|147395879|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for Chloride|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.014
73933056|NCT00408993|147395879|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for High Density Lipoprotein Cholesterol|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.005
73933057|NCT00408993|147395879|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Sodium|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.011
73971760|NCT05671653|147483830|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|185.45|||||TWO_SIDED|90.0|108.0|318.44||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 8)||318.44|108.00|
73933058|NCT00408993|147395879|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||P-value for triglycerides|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.044
73933059|NCT00408993|147395880|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-values.||||||0.017
73933060|NCT01923181|147395892|SUPERIORITY|This hypothesis was controlled for multiplicity.|Mean treatment difference|-1.47|||<|0.0001|TWO_SIDED|95.0|-1.73|-1.22|||Mixed Models Analysis||Oral semaglutide 40 mg pooled - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.22|-1.73|<0.0001
73933061|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.4||||0.0069|TWO_SIDED|95.0|-0.69|-0.11|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.11|-0.69|0.0069
73933062|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.18|-0.6|||Mixed Models Analysis||Oral semaglutide 5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.60|-1.18|<0.0001
73933063|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.47|-0.9|||Mixed Models Analysis||Oral semaglutide 10 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.90|-1.47|<0.0001
73933064|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.38|||<|0.0001|TWO_SIDED|95.0|-1.68|-1.09|||Mixed Models Analysis||Oral Semaglutide 20 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.09|-1.68|<0.0001
73933065|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-1.89|-1.3|||Mixed Models Analysis||Oral semaglutide 40 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.30|-1.89|<0.0001
73933066|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.14|||Mixed Models Analysis||Oral semaglutide 40 mg slow dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.14|-1.72|<0.0001
73933067|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.64|-1.04|||Mixed Models Analysis||Oral semaglutide 40 mg fast dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.04|-1.64|<0.0001
74030378|NCT01345786|147615006|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.3||||||90.0|98.1|104.7|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."|||104.7|98.1|
73933068|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.56|||<|0.0001|TWO_SIDED|95.0|-1.85|-1.27|||Mixed Models Analysis||Subcutaneous semaglutide 1 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.27|-1.85|<0.0001
73933069|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|1.16|||<|0.0001|TWO_SIDED|95.0|0.87|1.45|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||1.45|0.87|<0.0001
73933070|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.67|||<|0.0001|TWO_SIDED|95.0|0.38|0.96|||Mixed Models Analysis||Oral semaglutide 5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.96|0.38|<0.0001
73933071|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.37||||0.0116|TWO_SIDED|95.0|0.08|0.67|||Mixed Models Analysis||Oral semaglutide 10 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.67|0.08|0.0116
73933072|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.18||||0.244|TWO_SIDED|95.0|-0.12|0.47|||Mixed Models Analysis||Oral semaglutide 20 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.47|-0.12|0.2440
73933073|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.04||||0.7973|TWO_SIDED|95.0|-0.34|0.26|||Mixed Models Analysis||Oral semaglutide 40 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.26|-0.34|0.7973
73933074|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.13||||0.3901|TWO_SIDED|95.0|-0.16|0.42|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.42|-0.16|0.3901
73933075|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.22||||0.1612|TWO_SIDED|95.0|-0.09|0.52|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.52|-0.09|0.1612
73971761|NCT05671653|147483831|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|103.17|||||TWO_SIDED|90.0|95.09|111.93||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 5).||111.93|95.09|
73971762|NCT05671653|147483831|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|90.2|||||TWO_SIDED|90.0|60.24|135.06||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 8)||135.06|60.24|
73971763|NCT05671653|147483832|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|92.88|||||TWO_SIDED|90.0|79.97|107.87||||||Reference: Cohort 2: Midazolam 2 mg (Period 1). Test: Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3).||107.87|79.97|
73971764|NCT03738852|147483895|SUPERIORITY|||||||0.907|||||||ANOVA|||||||0.907
73971765|NCT02589795|147483930|OTHER|Inequality test|||||>|0.05|||||||Fisher Exact|||The proportions of subjects with primary safety outcomes were compared in a pairwise manner between the three randomised groups, using Fisher's exact tests.||||>0.05
73971766|NCT02589795|147483931|OTHER|Inequality test|||||>|0.05|||||||Kruskal-Wallis|Kruskal-Wallis test with Dunn's correction for multiple comparisons||Kruskal-Wallis test with Dunn's correction for multiple comparisons to compare the levels of antigen-specific serum IgG in the three groups at Week 22.||||>0.05
73971767|NCT04909801|147483952|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.9026
73971768|NCT04909801|147483953|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5824|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||||1.5|0.5|0.5824
73971769|NCT04909801|147483954|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3534||95.0|0.5|1.3|||Regression, Logistic|||||1.3|0.5|0.3534
73971770|NCT04909801|147483955|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.614|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||||1.5|0.5|0.6140
73971771|NCT04909801|147483957|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4996|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 29||1.4|0.5|0.4996
73971772|NCT04909801|147483957|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.449|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 57||1.4|0.5|0.4490
73971773|NCT04909801|147483957|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.809|TWO_SIDED|95.0|0.5|1.7|||Regression, Logistic|||Day 85||1.7|0.5|0.8090
73971774|NCT04909801|147483957|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.9||||0.0739|TWO_SIDED|95.0|0.9|3.6|||Regression, Logistic|||Day 113||3.6|0.9|0.0739
73971775|NCT04909801|147483957|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.4201|TWO_SIDED|95.0|0.7|2.6|||Regression, Logistic|||Day 141||2.6|0.7|0.4201
73971776|NCT04909801|147483957|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7928|TWO_SIDED|95.0|0.6|2.0|||Regression, Logistic|||Day 169||2.0|0.6|0.7928
73971777|NCT04909801|147483958|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2701|TWO_SIDED|95.0|0.4|1.3|||Regression, Logistic|||Day 29||1.3|0.4|0.2701
73971778|NCT04909801|147483958|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4863|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 57||1.4|0.5|0.4863
73971779|NCT04909801|147483958|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9513|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 85||1.7|0.6|0.9513
73865222|NCT02207491|147276368|NON_INFERIORITY|Clinical noninferiority was to be concluded if the upper limit of the 95% CIs around the difference (AR-13324 - timolol) was within 1.5 mmHg at all time points and was within 1.0 mmHg at a majority of the time points.|||||<|0.0001||||||Calculated p-value|ANCOVA|Statistical analysis applies at all 3 timepoints on Day 15, Day 43, and Day 90||Assuming zero difference between AR-13324 and timolol, a 2-tailed alpha of 0.05 at each of 9 time points, a common SD of 3.0 mmHg, and a correlation between time points of 0.60 or less, 170 PP subjects per arm were necessary to have 90% power to show clinical noninferiority of AR-13324 to timolol in mean IOP.||||<0.0001
73933076|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.17||||0.2669|TWO_SIDED|95.0|-0.13|0.46|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.46|-0.13|0.2669
73933077|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.26||||0.0989|TWO_SIDED|95.0|-0.05|0.56|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.56|-0.05|0.0989
73933078|NCT01923181|147395892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.09||||0.5565|TWO_SIDED|95.0|-0.21|0.39|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg slow-dose escalation|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.39|-0.21|0.5565
73933079|NCT01257204|147395941|SUPERIORITY_OR_OTHER||Difference|20.8|||||TWO_SIDED|80.0|4.9|36.8|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||36.8|4.9|
73933080|NCT01257204|147395941|SUPERIORITY_OR_OTHER||Difference|20.1|||||TWO_SIDED|80.0|3.9|36.3|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||36.3|3.9|
73933081|NCT01257204|147395950|SUPERIORITY_OR_OTHER||Difference|10.0|||||TWO_SIDED|80.0|-6.8|26.7|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||26.7|-6.8|
73933082|NCT01257204|147395950|SUPERIORITY_OR_OTHER||Difference|7.4|||||TWO_SIDED|80.0|-9.4|24.2|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||24.2|-9.4|
73933083|NCT01863446|147395956|SUPERIORITY|Unpaired t-test comparing Lighting 1 and Lighting2||||||0.334|||||||t-test, 2 sided|||||||0.334
73933084|NCT01863446|147395956|SUPERIORITY|Unpaired t-test comparing Lighting3 vs Lighting 4||||||0.423|||||||t-test, 2 sided|||||||0.423
73933085|NCT01863446|147395957|SUPERIORITY|Unpaired t-test of Lighting1 vs Lighting2||||||0.78|||||||t-test, 2 sided|||||||0.780
73933086|NCT01863446|147395957|SUPERIORITY|Unpaired t-test of Lighting3 vs Lighting4||||||0.791|||||||t-test, 2 sided|||||||0.791
73933087|NCT01863446|147395958|SUPERIORITY|Unpaired t-test||||||0.883|||||||t-test, 2 sided|||||||0.883
73933088|NCT01863446|147395958|SUPERIORITY|Unpaired t-test||||||0.271|||||||t-test, 2 sided|||||||0.271
73933089|NCT02312310|147395963|SUPERIORITY|Test of trend across doses.||||||0.393|||||||Mixed Models Analysis|Change in outcome from baseline to 12 weeks tested using mixed effects models controlling for baseline measures, treatment, sex, age, and education.|||The flavanol effect on the change in each outcome from baseline to 12 weeks was tested using linear mixed effects models controlling for the respective baseline measures, four categories of treatment, sex, age, and education. Regression adjusted mean within-group tests of change were estimated and tested for statistical significance from the model. The primary test used for assessing the treatment effect was the linear trend contrast from the model across: placebo, low, medium and high dose. The model for cognitive measures incorporated additional outcome measurement times at 4 weeks and 20 weeks and included categorical time (4, 12, 20 weeks) as a predictor as well as a treatment (4 category) by time interaction, and a random intercept to control for repeated measures within individuals (results for 4 and 20 weeks not presented).|||.393
73865223|NCT00599755|147276370|SUPERIORITY_OR_OTHER||Proportion|0.4|||||TWO_SIDED|80.0|0.27|0.55||||||||0.55|0.27|
73933090|NCT00491244|147395968|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8|||<|0.001|TWO_SIDED|95.0|1.46|2.21|||Chi-squared|||||2.21|1.46|< 0.001
73933091|NCT00491244|147395969|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.61||||0.35|TWO_SIDED|95.0|0.65|4.01|||Chi-squared|||||4.01|0.65|0.35
73933092|NCT01276327|147395970|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|97.11|102.81|||Unscaled average Bioequivalence||Geometric standard error of mean was calculated.|||102.81|97.11|
73933093|NCT01276327|147395971|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|94.17|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|89.08|99.55|||Unscaled average Bioequivalence||Geometric Standard error of mean was calculated.|||99.55|89.08|
73933094|NCT01276327|147395972|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together.|Adjusted gMean Ratio (Test/Ref) (%)|79.99|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|74.65|85.72|||Scaled average bioequivalence (SABE)||Geometric Standard error of mean was calculated.|||85.72|74.65|
73865224|NCT00599755|147276371|SUPERIORITY_OR_OTHER||Concordance correlation coefficient|0.88|||||TWO_SIDED|80.0|0.85|0.92||||||||0.92|0.85|
73865225|NCT00599755|147276375|SUPERIORITY_OR_OTHER||Proportion|0.125|||||TWO_SIDED|80.0|0.06|0.23||||||||0.23|0.06|
73971780|NCT04909801|147483958|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8536|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Day 113||1.8|0.6|0.8536
73971781|NCT04909801|147483958|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9223|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 141||1.7|0.6|0.9223
73971782|NCT04909801|147483958|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||Day 169||1.6|0.6|0.9026
73971783|NCT04909801|147483959|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.3411|TWO_SIDED|95.0|0.2|1.6|||Regression, Logistic|||Day 29||1.6|0.2|0.3411
73971784|NCT04909801|147483959|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2546|TWO_SIDED|95.0|0.4|1.3|||Regression, Logistic|||Day 57||1.3|0.4|0.2546
73971785|NCT04909801|147483959|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4558|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 85||1.4|0.5|0.4558
73971786|NCT04909801|147483959|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9544|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 113||1.7|0.6|0.9544
73971787|NCT04909801|147483959|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.545|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 141||1.4|0.5|0.5450
73971788|NCT04909801|147483959|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2227|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||Day 169||1.2|0.4|0.2227
73971789|NCT04909801|147483960|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.32|TWO_SIDED|95.0|0.3|1.4|||Regression, Logistic|||Day 29||1.4|0.3|0.3200
73971790|NCT04909801|147483960|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4992|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 57||1.5|0.5|0.4992
74039401|NCT04847141|147632409|SUPERIORITY||Difference in Percentage|6.9||||0.2104|TWO_SIDED|95.0|-4.2|18.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 14||18.0|-4.2|0.2104
73971791|NCT04909801|147483960|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.8963|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 85||1.7|0.6|0.8963
73971792|NCT04909801|147483960|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4544|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 113||1.4|0.5|0.4544
73971793|NCT04909801|147483960|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.8985|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Day 141||1.8|0.6|0.8985
73971794|NCT04909801|147483960|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5824|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 169||1.5|0.5|0.5824
73971795|NCT04909801|147483961|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.5||||0.4152|TWO_SIDED|95.0|0.6|4.1|||Regression, Logistic|||Day 29||4.1|0.6|0.4152
73971796|NCT04909801|147483961|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5917|TWO_SIDED|95.0|0.6|2.5|||Regression, Logistic|||Day 57||2.5|0.6|0.5917
73971797|NCT04909801|147483961|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.4||||0.3348|TWO_SIDED|95.0|0.7|2.6|||Regression, Logistic|||Day 85||2.6|0.7|0.3348
73971798|NCT04909801|147483961|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3959|TWO_SIDED|95.0|0.4|1.4|||Regression, Logistic|||Day 113||1.4|0.4|0.3959
73971799|NCT04909801|147483961|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.6225|TWO_SIDED|95.0|0.7|2.0|||Regression, Logistic|||Day 141||2.0|0.7|0.6225
73971800|NCT04909801|147483961|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.614|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 169||1.5|0.5|0.6140
73971801|NCT04909801|147483962|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8084|TWO_SIDED|95.0|0.4|2.9|||Regression, Logistic|||Day 29||2.9|0.4|0.8084
73971802|NCT04909801|147483962|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.747|TWO_SIDED|95.0|0.5|2.3|||Regression, Logistic|||Day 57||2.3|0.5|0.7470
73971803|NCT04909801|147483962|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5233|TWO_SIDED|95.0|0.7|2.3|||Regression, Logistic|||Day 85||2.3|0.7|0.5233
73971804|NCT04909801|147483962|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7295|TWO_SIDED|95.0|0.5|1.6|||Regression, Logistic|||Day 113||1.6|0.5|0.7295
73971805|NCT04909801|147483962|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7621|TWO_SIDED|95.0|0.6|1.9|||Regression, Logistic|||Day 141||1.9|0.6|0.7621
73971806|NCT04909801|147483962|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.6861|TWO_SIDED|95.0|0.5|1.6|||Regression, Logistic|||Day 169||1.6|0.5|0.6861
73971807|NCT04909801|147483963|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3117|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|||Day 29||1.2|0.5|0.3117
73971808|NCT04909801|147483963|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.612|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 57||1.4|0.6|0.6120
73971809|NCT04909801|147483963|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4339|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 85||1.3|0.5|0.4339
73971810|NCT04909801|147483963|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.5||||0.1963|TWO_SIDED|95.0|0.8|2.6|||Regression, Logistic|||Day 113||2.6|0.8|0.1963
73971811|NCT04909801|147483963|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3275|TWO_SIDED|95.0|0.8|2.3|||Regression, Logistic|||Day 141||2.3|0.8|0.3275
73971812|NCT04909801|147483963|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9113|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 169||1.7|0.6|0.9113
73971813|NCT04909801|147483964|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.1247|TWO_SIDED|95.0|0.4|1.1|||Regression, Logistic|||Day 29||1.1|0.4|0.1247
73971814|NCT04909801|147483964|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5656|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 57||1.4|0.6|0.5656
73971815|NCT04909801|147483964|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.897|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 85||1.5|0.6|0.8970
73971816|NCT04909801|147483964|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9175|TWO_SIDED|95.0|0.7|1.6|||Regression, Logistic|||Day 113||1.6|0.7|0.9175
74088788|NCT03135899|147730613|OTHER||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.31|3.95|||Regression, Cox||BI 443651 100 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||3.95|1.31|
73933095|NCT01276327|147395973|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|97.31|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|88.9|106.51|||Scaled average bioequivalence (SABE)||Geometric standard error of mean was calculated.|||106.51|88.90|
73865226|NCT01364740|147276376|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
73865227|NCT01364740|147276377|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
73933096|NCT01276327|147395974|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|97.1|102.81|||Unscaled average bioequivalence||Geometric Standard error of mean was calculated.|||102.81|97.10|
73933097|NCT01276327|147395975|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|101.85|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|98.18|105.67|||Unscaled average bioequivalence||Geometric standard error of mean was calculated.|||105.67|98.18|
73933098|NCT01276327|147395976|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|80.79|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|75.6|86.34|||Scaled average bioequivalence (SABE)||Geometric standard error of mean was calculated.|||86.34|75.60|
73933099|NCT05209191|147395980|SUPERIORITY||Mean Difference (Net)|7.28|STANDARD_DEVIATION|0.65||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
73933100|NCT05209191|147395982|SUPERIORITY||Mean Difference (Net)|0.08||||0.38|TWO_SIDED||||||t-test, 2 sided|||Paired t-test.||||.38
73933101|NCT05209191|147395983|SUPERIORITY||Chi square|52.07||||0.001|TWO_SIDED||||||Chi-squared|||||||.001
73933102|NCT04713748|147395989|OTHER||||||<|0.0001|||||||Interclass correlation coefficient|||||||<0.0001
73933103|NCT01410110|147395999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.66|STANDARD_ERROR_OF_MEAN|4.41||0.55|TWO_SIDED|95.0|-11.57|6.25||a prior threshold p \< .05|t-test, 2 sided|df = 40||t-test for equality of means||6.25|-11.57|.55
73933104|NCT01410110|147396000|SUPERIORITY_OR_OTHER||Slope|0.162|STANDARD_ERROR_OF_MEAN|0.94||0.86|TWO_SIDED|95.0|-1.73|2.05||Time X Condition|Mixed Models Analysis|Mixed Models allows for all randomized participants (N=48) to be included in the model.||F Test (df = 1,39.32), Type III Fixed Effects for Time X Condition||2.05|-1.73|.86
73933105|NCT01410110|147396001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.49|STANDARD_ERROR_OF_MEAN|2.41|<|0.31|TWO_SIDED|95.0|-7.36|2.39||a priori threshold p \< .05|t-test, 2 sided|||||2.39|-7.36|<.31
73933106|NCT01410110|147396002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.952||0.87|TWO_SIDED|95.0|-1.77|2.08||a priori threshold p \< .05|t-test, 2 sided|df=39||||2.08|-1.77|.87
73933107|NCT01410110|147396003|SUPERIORITY_OR_OTHER||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.84||0.67|TWO_SIDED|95.0|-2.07|1.33|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,36.86)||1.33|-2.07|.67
73933108|NCT01410110|147396004|SUPERIORITY_OR_OTHER||Slope|-0.42|STANDARD_ERROR_OF_MEAN|0.62||0.5|TWO_SIDED|95.0|-1.67|0.83|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition, F Test F (df = 1,42.4)||.83|-1.67|.50
73933109|NCT01410110|147396005|SUPERIORITY_OR_OTHER||Slope|1.16|STANDARD_ERROR_OF_MEAN|0.42||0.008|TWO_SIDED|95.0|0.32|2.01|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,70.15)||2.01|.32|.008
73933110|NCT01410110|147396006|SUPERIORITY_OR_OTHER||Slope|2.025|STANDARD_ERROR_OF_MEAN|0.93||0.03|TWO_SIDED|95.0|0.169|3.93|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,37.8)||3.93|.169|.03
73933111|NCT01410110|147396007|SUPERIORITY_OR_OTHER||Slope|3.86|STANDARD_ERROR_OF_MEAN|2.77||0.17|TWO_SIDED|95.0|-1.73|9.46||a priori p-value is .05. for two-tailed test. Positive estimated value is in the direction of the experimental condition.|Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,39.8)||9.46|-1.73|.17
73933112|NCT02802345|147396011|SUPERIORITY||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|1.431||0.7191|TWO_SIDED|95.0|-3.33|2.3|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks).|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment-by-visit and baseline SGRQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.|"H0: There is no difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone.~Ha: There is a difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone."|2.30|-3.33|0.7191
73933113|NCT02802345|147396012|SUPERIORITY||Adjusted mean difference|-2.94|STANDARD_ERROR_OF_MEAN|2.198||0.1823|TWO_SIDED|95.0|-7.27|1.39|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment-by-visit and baseline UCSD SOBQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.||1.39|-7.27|0.1823
73865228|NCT01364740|147276378|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
74030379|NCT04436510|147615013|SUPERIORITY||Disease Rate Ratio|0.98|STANDARD_DEVIATION|0.118|||TWO_SIDED|95.0|0.769|1.237||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. verdiperstat slowed progression) was 0.57467. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by verdiperstat relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.237|0.769|
73865229|NCT01364740|147276379|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
73865230|NCT02596230|147276427|OTHER||Hazard Ratio (HR)|0.634||||0.188|TWO_SIDED|95.0|0.322|1.249||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.249|0.322|0.188
73865231|NCT02596230|147276428|OTHER||Hazard Ratio (HR)|0.778||||0.606|TWO_SIDED|95.0|0.3|2.017||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||2.017|0.300|0.606
73865232|NCT02596230|147276429|OTHER||Hazard Ratio (HR)|0.751||||0.542|TWO_SIDED|95.0|0.299|1.885||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.885|0.299|0.542
73865233|NCT02596230|147276430|OTHER||Hazard Ratio (HR)|0.0||||0.996|TWO_SIDED|95.0||||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|"Hazard Ratio \< 1 favors Dabigatran etexilate.~Hazard Ratio is actually \<0.01~95% Confidence Interval is not calculable (NA) due to insufficient number of participants with events."|||||0.996
73865234|NCT02596230|147276431|OTHER||Hazard Ratio (HR)|0.857||||0.69|TWO_SIDED|95.0|0.402|1.828||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.828|0.402|0.690
73865235|NCT02868229|147276464|SUPERIORITY||Differences of LS Means|-5.666||||0.002|TWO_SIDED|95.0|-9.082|-2.25|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-2.250|-9.082|0.002
73933114|NCT02802345|147396013|SUPERIORITY||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|1.631||0.1809|TWO_SIDED|95.0|-5.4|1.02|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment-by-visit and baseline SGRQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned.||1.02|-5.40|0.1809
73933115|NCT02802345|147396014|SUPERIORITY||Adjusted mean difference|-2.41|STANDARD_ERROR_OF_MEAN|2.529||0.3421|TWO_SIDED|95.0|-7.39|2.58|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment-by-visit and baseline UCSD SOBQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned.||2.58|-7.39|0.3421
73933116|NCT02802345|147396015|SUPERIORITY||Percentage ratio (%)|0.83|||||TWO_SIDED|95.0|0.58|1.2|||||Within strata confidence limits are calculated according to Wald. Percentage ratio = (% of Nintedanib+sildenafil) / (% of Nintedanib+placebo).|Relative risk, Comparison of treatment groups is calculated by Cochran-Mantel-Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel-Haenszel type risk ratios and risk differences with 95% confidence are presented.||1.20|0.58|
73933117|NCT02802345|147396015|SUPERIORITY||Percentage difference (%)|-5.37||||0.334|TWO_SIDED|95.0|-16.25|5.52|||Cochran-Mantel-Haenszel||Within strata confidence limits are calculated according to Wald. Percentage difference = (% of Nintedanib+sildenafil) - (% of Nintedanib+placebo).|Risk difference, Comparison of treatment groups is calculated by Cochran-Mantel-Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel-Haenszel type risk ratios and risk differences with 95% confidence are presented.||5.52|-16.25|0.334
73933118|NCT04632940|147396016|OTHER||LS Mean Difference|-0.528|STANDARD_ERROR_OF_MEAN|0.8912||0.5553|TWO_SIDED|95.0|-2.308|1.251|||Mixed Models Analysis|||||1.251|-2.308|0.5553
73933119|NCT02799082|147396029|SUPERIORITY_OR_OTHER||||||<|0.0001||||||"The percentages stated relate to the total number of subjects for the respective week and treatment.~Cochran-Mantel-Haenszel Test stratified by center"|Cochran-Mantel-Haenszel|||||||<0.0001
73933120|NCT02799082|147396030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73933121|NCT02799082|147396038|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73933122|NCT02799082|147396039|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73933123|NCT02442700|147396077|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73933124|NCT00752908|147396109|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73933125|NCT02617589|147396114|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.31||||0.0037|TWO_SIDED|95.0|1.09|1.58|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.58|1.09|0.0037
73933126|NCT02617589|147396115|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.43|||||TWO_SIDED|95.0|1.19|1.71|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.71|1.19|
74030380|NCT04436510|147615015|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_ERROR_OF_MEAN|2.054||0.8875|TWO_SIDED|95.0|-3.74|4.32|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Verdiperstat 24-week change from baseline relative to placebo 24-week change from baseline.|||4.32|-3.74|0.8875
74030381|NCT04436510|147615016|SUPERIORITY||Mean Difference (Net)|3.57|STANDARD_ERROR_OF_MEAN|3.848||0.3538|TWO_SIDED|95.0|-3.99|11.13|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Verdiperstat 24-week change from baseline relative to placebo 24-week change from baseline.|||11.13|-3.99|0.3538
74030382|NCT04436510|147615017|SUPERIORITY|||||||0.318|||||||Log Rank|||||||0.318
73933127|NCT02617589|147396119|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.31||||0.0024|TWO_SIDED|95.0|1.1|1.55|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.55|1.10|0.0024
73933128|NCT01649856|147396120|SUPERIORITY_OR_OTHER||Difference in Response Rates|8.2||||0.076||95.0|-1.1|17.5|||Chi-squared|||||17.5|-1.1|0.076
73933129|NCT04551105|147396168|SUPERIORITY||different in area under the LROC curve|0.0374|||<|0.05|TWO_SIDED|95.0|0.019|0.0557|||OR-DBM model|||||0.0557|0.0190|<0.05
73933130|NCT04551105|147396169|SUPERIORITY||Mean Difference (Net)|12.78|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73933131|NCT04551105|147396170|SUPERIORITY||different in sensitivity|-0.0013|||<|0.05|TWO_SIDED|95.0|-0.2307|0.2281|||McNemar|||||0.2281|-0.2307|<0.05
73933132|NCT04551105|147396170|SUPERIORITY||different in specificity|0.1065|||<|0.05|TWO_SIDED|95.0|0.0008|0.2122|||McNemar|||||0.2122|0.0008|<0.05
73933133|NCT04551105|147396170|SUPERIORITY||different in PPV|-0.086|||<|0.05|TWO_SIDED|95.0|-0.1824|0.0104|||McNemar|||||0.0104|-0.1824|<0.05
73933134|NCT04551105|147396170|SUPERIORITY||different in NPV|0.086|||<|0.05|TWO_SIDED|95.0|-0.0104|0.1824|||McNemar|||||0.1824|-0.0104|<0.05
73933135|NCT02066298|147396177|SUPERIORITY|||||||0.14|||||||exact binomial test|a priori threshold for significance was 0.025||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.||||0.14
73933136|NCT02066298|147396177|SUPERIORITY|||||||0.029||||||a priori threshold for significance was 0.025|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.||||0.029
73933137|NCT02066298|147396177|SUPERIORITY|||||||0.001||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. This was an exploratory analysis and there were no power considerations.||||0.001
73933138|NCT02066298|147396177|SUPERIORITY|||||||0.45||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. This was an exploratory analysis and there were no power considerations.||||0.45
73933139|NCT00274716|147396214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.6||0.157|TWO_SIDED|95.0|-5.3|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.9|-5.3|0.157
73933140|NCT00274716|147396214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.5||0.01|TWO_SIDED|95.0|-7.1|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-1.0|-7.1|0.010
73933141|NCT00274716|147396214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|1.6||0.042|TWO_SIDED|95.0|-6.4|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-0.1|-6.4|0.042
73933142|NCT00274716|147396214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.6||0.517|TWO_SIDED|95.0|-2.1|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||4.1|-2.1|0.517
73933143|NCT00274716|147396214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.602|TWO_SIDED|95.0|-3.9|2.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||2.3|-3.9|0.602
73933144|NCT00274716|147396215|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|2.4||0.046|TWO_SIDED|95.0|-9.7|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-0.1|-9.7|0.046
73933145|NCT00274716|147396215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|2.4||0.108|TWO_SIDED|95.0|-8.7|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.9|-8.7|0.108
73933146|NCT00274716|147396215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.5||0.099|TWO_SIDED|95.0|-9.0|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.8|-9.0|0.099
73933147|NCT00274716|147396215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|2.5||0.752|TWO_SIDED|95.0|-5.7|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||4.1|-5.7|0.752
73933148|NCT00274716|147396215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.5||0.941|TWO_SIDED|95.0|-4.7|5.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||5.0|-4.7|0.941
73865236|NCT02868229|147276464|SUPERIORITY||Differences of LS Means|-6.913|||<|0.001|TWO_SIDED|95.0|-10.613|-3.214|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-3.214|-10.613|<0.001
73865237|NCT02868229|147276464|SUPERIORITY||Differences of LS Means|-9.591|||<|0.001|TWO_SIDED|95.0|-13.217|-5.965|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-5.965|-13.217|<0.001
73865238|NCT02250664|147276599|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
73865239|NCT02250664|147276599|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANOVA|||The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.|Group difference = 0.03 mg nicotine - 0.8 mg nicotine|-5.57|-9.51|<0.0001
73971817|NCT04909801|147483964|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.5996|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 141||1.7|0.7|0.5996
73971818|NCT04909801|147483964|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3534|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 169||1.3|0.5|0.3534
73971819|NCT04909801|147483965|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.1641|TWO_SIDED|95.0|0.2|1.3|||Regression, Logistic|||Day 29||1.3|0.2|0.1641
74030383|NCT01000064|147615062|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.053
74030384|NCT01000064|147615063|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.052
74030385|NCT01000064|147615064|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
73865240|NCT00117793|147276600|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on limb volume was analyzed using repeated measures one-way analyses of variance.||||||>0.05
74030386|NCT01000064|147615065|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
73865241|NCT00117793|147276601|SUPERIORITY_OR_OTHER||||||=|0.0056||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on activity level was analyzed using repeated measures one-way analyses of variance.||||||=0.0056
73865242|NCT00117793|147276602|SUPERIORITY_OR_OTHER||||||=|0.0021||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on limb pistoning was analyzed using repeated measures one-way analyses of variance.||||||=0.0021
73865243|NCT04268173|147276606|EQUIVALENCE|A two sample t-test was conducted to test the null hypothesis that the pre-intervention mean response was equivalent to the post-intervention mean response in the Prevention Navigation group. Hypothesis: A p-value greater than 0.05 suggests the means are not statistically different from one another.||||||0.84|||||||t-test, 2 sided|||||||0.84
73865244|NCT00545103|147276618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.778||95.0|||||Cochran-Mantel-Haenszel|||||||0.778
73971820|NCT04909801|147483965|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5905|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 57||1.5|0.5|0.5905
73971821|NCT04909801|147483965|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7146|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 85||1.5|0.6|0.7146
73971822|NCT04909801|147483965|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7416|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 113||1.7|0.7|0.7416
73971823|NCT04909801|147483965|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 141||1.5|0.6|0.9026
73971824|NCT04909801|147483965|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.2605|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|||Day 169||1.2|0.5|0.2605
73971825|NCT04909801|147483966|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.1078|TWO_SIDED|95.0|0.3|1.1|||Regression, Logistic|||Day 29||1.1|0.3|0.1078
73971826|NCT04909801|147483966|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.1855|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||Day 57||1.2|0.4|0.1855
73971827|NCT04909801|147483966|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5223|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 85||1.4|0.6|0.5223
74030387|NCT01000064|147615066|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
74030388|NCT01000064|147615067|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.040
74030389|NCT01000064|147615068|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
74030390|NCT02389946|147615080|NON_INFERIORITY|Non-inferiority of the 12-month TLF rate for the Orsiro stent vs. the Xience stent was assessed as the primary endpoint. The null hypothesis H0 was that the Orsiro stent would have a primary endpoint (12-month TLF) rate equal to or exceeding that of the Xience group by the non-inferiority margin or more. The alternative hypothesis HA was that the Orsiro stent would have a 12-month TLF rate less than the Xience group rate plus the non-inferiority margin of 3.85%.|Posterior Probability of non-inferioriry|100.0|||||TWO_SIDED|||||||||Bayesian calculation using a hierarchical model to incorporate data from previous BIOFLOW-II and BIOFLOW-IV trials.||||
74030391|NCT02389946|147615081|OTHER|||||||0.415|||||||Fisher Exact|||||||0.415
74030392|NCT03141307|147615100|EQUIVALENCE|95% margin|||||<|0.001||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.001
73865245|NCT00545103|147276618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.159||95.0|||||Cochran-Mantel-Haenszel|||||||0.159
73865246|NCT00545103|147276618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.368||95.0|||||Cochran-Mantel-Haenszel|||||||0.368
73865247|NCT00545103|147276619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||95.0|||||Cochran-Mantel-Haenszel|||||||0.685
74030393|NCT03141307|147615101|EQUIVALENCE|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.05
73865248|NCT00545103|147276619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198||95.0|||||Cochran-Mantel-Haenszel|||||||0.198
73865249|NCT00545103|147276619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441||95.0|||||Cochran-Mantel-Haenszel|||||||0.441
73865250|NCT01571453|147276636|NON_INFERIORITY_OR_EQUIVALENCE|Vortioxetine was declared to be non-inferior to venlafaxine if the upper limit of the calculated two-sided 95% confidence interval for the treatment difference at Week 8 between vortioxetine and venlafaxine was less than +2.5 MADRS units versus venlafaxine.|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.93||0.199||95.0|-3.03|0.63||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The sample size calculation was based on a non-inferiority comparison of the treatment groups in the change from baseline to Week 8 in MADRS total score using a two-sided 95% CI against a margin of +2.5 points. Assuming a standard deviation of 9.0 points and an expected true mean difference between treatments of 0 points, a total of 410 patients (205 per treatment group) were needed to provide a power of 80% for correctly concluding non-inferiority.||0.63|-3.03|0.199
73865251|NCT01571453|147276637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.12||0.228|TWO_SIDED|95.0|-0.39|0.09||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.09|-0.39|0.228
73865252|NCT01571453|147276638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.174|TWO_SIDED|95.0|-0.35|0.06||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.06|-0.35|0.174
73865253|NCT01571453|147276639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.65||0.207|TWO_SIDED|95.0|-2.09|0.45||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.45|-2.09|0.207
73865254|NCT01571453|147276640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.272||95.0|0.84|1.86||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||1.86|0.84|0.272
73865255|NCT01571453|147276641|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.731||95.0|0.73|1.58||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||1.58|0.73|0.731
73865256|NCT02453555|147276643|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.36|-0.91|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 24 in Empagliflozin 10 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 24 in Linagliptin 5 mg + Placebo 10 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.91|-1.36|<0.0001
73933149|NCT00274716|147396216|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.2|-0.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-0.7|-2.2|<0.001
73933150|NCT00274716|147396216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-0.4|-1.9|0.003
73933151|NCT00274716|147396216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-1.0|-2.4|<0.001
73933152|NCT00274716|147396216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.462|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||1.0|-0.5|0.462
73933153|NCT00274716|147396216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.4||0.118|TWO_SIDED|95.0|-0.2|1.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||1.3|-0.2|0.118
73933154|NCT00274716|147396217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.059|TWO_SIDED|95.0|-3.7|0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||0.1|-3.7|0.059
73933155|NCT00274716|147396217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-5.5|-1.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||-1.7|-5.5|<0.001
73933156|NCT00274716|147396217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.9||0.136|TWO_SIDED|95.0|-3.3|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||0.5|-3.3|0.136
73933157|NCT00274716|147396217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.9||0.686|TWO_SIDED|95.0|-2.2|1.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||1.4|-2.2|0.686
73933158|NCT00274716|147396217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|0.9||0.022|TWO_SIDED|95.0|-4.0|-0.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||-0.3|-4.0|0.022
73865257|NCT02453555|147276645|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.45|-0.99|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in All Empagliflozin group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.99|-1.45|<0.0001
73865258|NCT02453555|147276646|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.21|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.45|-0.96|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in Linagliptin 5 mg + Placebo 25 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.96|-1.45|<0.0001
73865259|NCT02453555|147276647|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.34|-0.84|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.84|-1.34|<0.0001
73865260|NCT02039856|147276674|SUPERIORITY|Difference-in-differences using ordered logistic regression, adjusting for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights. We verified that proportional odds assumption was met.|Odds Ratio (OR)|0.913|STANDARD_ERROR_OF_MEAN|0.175||0.637|TWO_SIDED|95.0|0.627|1.33|||difference-in-differences analysis||The estimated value is predicted change in the odds of WH-PACT achievement, adjusting for characteristics described in the statistical analysis overview.|Change in the odds of achieving a higher WH-PACT element.||1.33|0.627|0.637
73865261|NCT02039856|147276675|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.1195||0.006|TWO_SIDED|95.0|0.1|0.57|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in gender sensitivity score between EBQI and control over time||0.57|0.10|0.006
73865262|NCT02039856|147276676|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.2253||0.055|TWO_SIDED|95.0|-0.01|0.87|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in team functioning score between EBQI and control over time.||0.87|-0.01|0.055
73933159|NCT00274716|147396218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|4.3||0.005|TWO_SIDED|95.0|-20.8|-3.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||-3.7|-20.8|0.005
73933160|NCT00274716|147396218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|4.4||0.066|TWO_SIDED|95.0|-16.7|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||0.5|-16.7|0.066
73933161|NCT00274716|147396218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|4.5||0.319|TWO_SIDED|95.0|-13.4|4.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||4.4|-13.4|0.319
73933162|NCT00274716|147396218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|4.4||0.077|TWO_SIDED|95.0|-16.4|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||0.8|-16.4|0.077
73933163|NCT00274716|147396218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|4.4||0.418|TWO_SIDED|95.0|-12.2|5.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||5.1|-12.2|0.418
73933164|NCT00274716|147396219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|2.5||0.015|TWO_SIDED|95.0|-11.3|-1.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-1.2|-11.3|0.015
73933165|NCT00274716|147396219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|2.6||0.124|TWO_SIDED|95.0|-9.2|1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||1.1|-9.2|0.124
73933166|NCT00274716|147396219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.6||0.429|TWO_SIDED|95.0|-3.1|7.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||7.2|-3.1|0.429
73865263|NCT02039856|147276677|SUPERIORITY|We adjusted our analysis using the population weights, which were the product of design weights and non-response weights|Odds Ratio (OR)|0.36|STANDARD_ERROR_OF_MEAN|0.1922||0.058|TWO_SIDED|95.0|0.13|1.04|||Regression, Logistic||The estimated value is the predicted mean, adjusting for weights, worked in women's health vs general PC clinic, years worked at the VA, race/ethnicity, gender, full-time employment, and percent of women veterans enrolled at the VA facility.|||1.04|0.13|0.058
73865264|NCT02039856|147276678|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.56||0.008|TWO_SIDED|95.0|0.14|2.36|||Regression, Linear||The estimated value is predicted change in the number of VA primary care visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient primary care visits between EBQI and control over time||2.36|0.14|0.008
73865265|NCT02039856|147276679|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|0.413||0|TWO_SIDED|95.0|0.88|2.51|||Regression, Linear||The estimated value is predicted change in the number of VA women's health visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient visits to women's health care between EBQI and control over time||2.51|0.88|0.000
73971828|NCT04909801|147483966|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4078|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 113||1.3|0.5|0.4078
73971829|NCT04909801|147483966|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5238|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 141||1.8|0.7|0.5238
73971830|NCT04909801|147483966|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.474|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 169||1.3|0.5|0.4740
74030394|NCT03141307|147615102|EQUIVALENCE|95% margin|||||=|0.502||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||=.502
73865266|NCT02039856|147276680|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.068||0.794|TWO_SIDED|95.0|-0.15|0.12|||Regression, Linear||The estimated value is predicted change in the number of VA hospitalization, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient hospitalization for any cause between EBQI and control over time||0.12|-0.15|0.794
73865267|NCT02039856|147276681|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.15||0.888|TWO_SIDED|95.0|-0.265|0.306|||Regression, Linear||The estimated value is predicted change in the number of VA emergency room visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of emergency room visits for any cause between EBQI and control over time||0.306|-0.265|0.888
73971831|NCT04909801|147483967|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.6565|TWO_SIDED|95.0|0.5|2.9|||Regression, Logistic|||Day 29||2.9|0.5|0.6565
73971832|NCT04909801|147483967|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.701|TWO_SIDED|95.0|0.6|2.1|||Regression, Logistic|||Day 57||2.1|0.6|0.7010
73971833|NCT04909801|147483967|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3683|TWO_SIDED|95.0|0.8|2.1|||Regression, Logistic|||Day 85||2.1|0.8|0.3683
73971834|NCT04909801|147483967|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.6372|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 113||1.8|0.7|0.6372
73971835|NCT04909801|147483967|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.2922|TWO_SIDED|95.0|0.8|2.0|||Regression, Logistic|||Day 141||2.0|0.8|0.2922
73971836|NCT04909801|147483967|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8178|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 169||1.7|0.7|0.8178
73971837|NCT04909801|147483968|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9599|TWO_SIDED|95.0|0.4|2.2|||Regression, Logistic|||Day 29||2.2|0.4|0.9599
73971838|NCT04909801|147483968|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7899|TWO_SIDED|95.0|0.5|1.7|||Regression, Logistic|||Day 57||1.7|0.5|0.7899
73971839|NCT04909801|147483968|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.6305|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||Day 85||1.9|0.7|0.6305
73971840|NCT04909801|147483968|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3491|TWO_SIDED|95.0|0.8|2.0|||Regression, Logistic|||Day 113||2.0|0.8|0.3491
73971841|NCT04909801|147483968|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.4916|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||Day 141||1.9|0.7|0.4916
73971842|NCT04909801|147483968|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.5697|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 169||1.8|0.7|0.5697
73971843|NCT04909801|147483969|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.0977|TWO_SIDED|95.0|0.0|0.5|||longitudinal|||Day 29||0.5|-0.0|0.0977
73971844|NCT04909801|147483969|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.2889|TWO_SIDED|95.0|-0.1|0.5|||longitudinal|||Day 57||0.5|-0.1|0.2889
73971845|NCT04909801|147483969|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.7676|TWO_SIDED|95.0|-0.3|0.4|||longitudinal|||Day 85||0.4|-0.3|0.7676
74030395|NCT03141307|147615103|EQUIVALENCE|95% margin|||||=|0.071||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||=.071
74030396|NCT03141307|147615104|EQUIVALENCE|95% margin|||||=|0.124||||||a prior threshold for statistical significance set for p \< .05.|t-test, 2 sided|||||||=.124
74030397|NCT03141307|147615105|EQUIVALENCE|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.05
73865268|NCT02409342|147276682|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.595||||0.0106|TWO_SIDED|95.0|0.398|0.89|||Log Rank|||TC3 or IC3-WT Population||0.890|0.398|0.0106
73865269|NCT02409342|147276683|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.868||||0.3091|TWO_SIDED|95.0|0.661|1.14|||Log Rank|||TC2/3 or IC2/3-WT Population||1.140|0.661|0.3091
73865270|NCT02409342|147276683|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.845||||0.107|TWO_SIDED|95.0|0.688|1.037||P-value is descriptive as it was not formally tested.|Log Rank|||TC1/2/3 or IC/1/2/3-WT||1.037|0.688|0.1070
73865271|NCT02409342|147276684|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.63||||0.007|TWO_SIDED|95.0|0.449|0.884||P-value is descriptive as it was not formally tested.|Log Rank|||TC3 or IC3-WT Population||0.884|0.449|0.0070
73865272|NCT02409342|147276685|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.641||||0.0004|TWO_SIDED|95.0|0.501|0.82||P-value is descriptive as it was not formally tested.|Log Rank|||TC2/3 or IC2/3-WT Population||0.820|0.501|0.0004
73865273|NCT02409342|147276685|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.716||||0.0004|TWO_SIDED|95.0|0.595|0.863||P-value is descriptive as it was not formally tested.|Log Rank|||TC1/2/3 or IC1/2/3-WT Population||0.863|0.595|0.0004
73865274|NCT02409342|147276686|SUPERIORITY|Stratified Analysis|Difference in ORR|9.75|||||TWO_SIDED|95.0|-4.07|23.56||||||TC3 or IC3-WT Population||23.56|-4.07|
73865275|NCT02409342|147276687|SUPERIORITY|Stratified analysis|Difference in ORR|1.64|||||TWO_SIDED|95.0|-9.14|12.42||||||TC2/3 or IC2/3-WT Population||12.42|-9.14|
73865276|NCT02409342|147276687|SUPERIORITY|Stratified analysis|Difference in ORR|-0.72|||||TWO_SIDED|95.0|-8.84|7.39||||||TC1/2/3 or IC1/2/3-WT Population||7.39|-8.84|
73865277|NCT02409342|147276688|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.365|||||TWO_SIDED|95.0|0.166|0.8||||||TC3 or IC3-WT Population||0.800|0.166|
74030398|NCT02574312|147615143|NON_INFERIORITY|Non-Inferiority Analysis of absolute value of mechanical axis alignment with NI margin of 1.5 degrees, using a 1-sided T-test with alpha of 0.05. Anticipated power was 95%.||||||0.028|||||||t-test, 1 sided|||||||0.028
73865278|NCT02409342|147276689|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.235|||||TWO_SIDED|95.0|0.135|0.409||||||TC2/3 or IC2/3-WT Population||0.409|0.135|
73865279|NCT02409342|147276689|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.284|||||TWO_SIDED|95.0|0.19|0.424||||||TC1/2/3 or IC1/2/3-WT Population||0.424|0.190|
73865280|NCT02409342|147276690|SUPERIORITY||Difference in Event Free Rate|14.26|||||TWO_SIDED|95.0|-0.03|28.55||||||1-Year TC3 or IC3-WT Population||28.55|-0.03|
73865281|NCT02409342|147276691|SUPERIORITY||Difference in Event Free Rate|20.7|||||TWO_SIDED|95.0|2.94|38.47||||||2-Years TC3 or IC3-WT Population||38.47|2.94|
73865282|NCT02409342|147276692|SUPERIORITY||Difference in Event Free Rate|4.74|||||TWO_SIDED|95.0|-5.93|15.4||||||1-Year TC2/3 or IC2/3-WT Population||15.40|-5.93|
73865283|NCT02409342|147276692|SUPERIORITY||Difference in Event Free Rate|5.06|||||TWO_SIDED|95.0|-3.27|13.4||||||1-Year TC1/2/3 or IC1/2/3-WT Population||13.40|-3.27|
73865284|NCT02409342|147276693|SUPERIORITY||Difference in Event Free Rate|8.73|||||TWO_SIDED|95.0|-1.99|19.45||||||2-Years TC2/3 or IC2/3-WT Population||19.45|-1.99|
73865285|NCT02409342|147276693|SUPERIORITY||Difference in Event Free Rate|10.94|||||TWO_SIDED|95.0|2.83|19.04||||||2-Years TC1/2/3 or IC1/2/3-WT Population||19.04|2.83|
73865286|NCT02409342|147276694|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.142|||||TWO_SIDED|95.0|0.657|1.984||||||Cough in TC3 or IC3-WT Populations||1.984|0.657|
73865287|NCT02409342|147276694|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.891|||||TWO_SIDED|95.0|0.555|1.43||||||Dyspnoea in TC3 or IC3-WT Populations||1.430|0.555|
73865288|NCT02409342|147276694|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|1.229|||||TWO_SIDED|95.0|0.737|2.049||||||Chest pain in TC3 or IC3-WT Populations||2.049|0.737|
73865289|NCT02409342|147276696|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.984|||||TWO_SIDED|95.0|0.477|2.03||||||Cough for TC3 or IC3-WT Populations||2.030|0.477|
73865290|NCT02409342|147276696|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.955|||||TWO_SIDED|95.0|0.569|1.604||||||Dyspnea for TC3 or IC3-WT Populations||1.604|0.569|
73865291|NCT02409342|147276696|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|1.024|||||TWO_SIDED|95.0|0.472|2.222||||||Chest pain for TC3 or IC3-WT Populations||2.222|0.472|
73865292|NCT02409342|147276697|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.707|||||TWO_SIDED|95.0|0.5|1.0||||||SP263 \>=50%-WT Population||1.000|0.500|
73865293|NCT02409342|147276697|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.693|||||TWO_SIDED|95.0|0.502|0.956||||||SP263 \>=25%-WT Population||0.956|0.502|
73865294|NCT02409342|147276697|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.768|||||TWO_SIDED|95.0|0.579|1.018||||||SP263 \>=1%-WT Population||1.018|0.579|
73865295|NCT02409342|147276698|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.674|||||TWO_SIDED|95.0|0.511|0.89||||||SP263 \>=50%-WT Population||0.890|0.511|
73865296|NCT02409342|147276698|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.698|||||TWO_SIDED|95.0|0.539|0.904||||||SP263 \>=25%-WT Population||0.904|0.539|
73865297|NCT02409342|147276698|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.725|||||TWO_SIDED|95.0|0.577|0.91||||||SP263 \>=1%-WT Population||0.910|0.577|
73865298|NCT02409342|147276699|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.867|||||TWO_SIDED|95.0|0.578|1.301||||||bTMB \>=10-WT Population||1.301|0.578|
73865299|NCT02409342|147276699|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.748|||||TWO_SIDED|95.0|0.414|1.351||||||bTMB \>=16-WT Population||1.351|0.414|
73865300|NCT02409342|147276699|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.362|1.638||||||bTMB \>=20-WT Population||1.638|0.362|
73865301|NCT02409342|147276700|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.743|||||TWO_SIDED|95.0|0.525|1.052||||||bTMB \>=10-WT Population||1.052|0.525|
73865302|NCT02409342|147276700|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.553|||||TWO_SIDED|95.0|0.331|0.924||||||bTMB \>=16-WT Population||0.924|0.331|
74091641|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|9.4|||||TWO_SIDED|95.0|5.42|16.28|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15A||16.28|5.42|
74091642|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.13|||||TWO_SIDED|95.0|1.25|3.63|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15C||3.63|1.25|
73865303|NCT02409342|147276700|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.295|1.062||||||bTMB \>=20-WT Population||1.062|0.295|
73865304|NCT03268941|147276733|OTHER||Least Square (LS) Mean Difference|7.38|||<|0.001|TWO_SIDED|95.0|4.03|13.52||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||13.52|4.03|<0.001
73971846|NCT04909801|147483969|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.6157|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 113||0.2|-0.3|0.6157
73971847|NCT04909801|147483969|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.3904|TWO_SIDED|95.0|-0.4|0.2|||longitudinal|||Day 141||0.2|-0.4|0.3904
73971848|NCT04909801|147483969|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.8359|TWO_SIDED|95.0|-0.4|0.3|||longitudinal|||Day 169||0.3|-0.4|0.8359
73971849|NCT04909801|147483970|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.4||||0.7852|TWO_SIDED|95.0|-2.3|3.1|||longitudinal|||Day 29||3.1|-2.3|0.7852
73971850|NCT04909801|147483970|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.6336|TWO_SIDED|95.0|-2.0|3.3|||longitudinal|||Day 57||3.3|-2.0|0.6336
73971851|NCT04909801|147483970|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.9||||0.4879|TWO_SIDED|95.0|-3.5|1.7|||longitudinal|||Day 85||1.7|-3.5|0.4879
74091643|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.8|||||TWO_SIDED|95.0|1.64|4.79|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15C||4.79|1.64|
73971852|NCT04909801|147483970|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.2812|TWO_SIDED|95.0|-3.5|1.0|||longitudinal|||Day 113||1.0|-3.5|0.2812
73971853|NCT04909801|147483970|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.7||||0.1205|TWO_SIDED|95.0|-3.9|0.5|||longitudinal|||Day 141||0.5|-3.9|0.1205
73971854|NCT04909801|147483970|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.4||||0.3001|TWO_SIDED|95.0|-4.1|1.3|||longitudinal|||Day 169||1.3|-4.1|0.3001
73971855|NCT04909801|147483971|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.2||||0.4107|TWO_SIDED|95.0|-1.6|4.0|||longitudinal|||Day 29||4.0|-1.6|0.4107
73971856|NCT04909801|147483971|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.5||||0.6824|TWO_SIDED|95.0|-2.1|3.2|||longitudinal|||Day 57||3.2|-2.1|0.6824
73971857|NCT04909801|147483971|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.7||||0.5793|TWO_SIDED|95.0|-3.4|1.9|||longitudinal|||Day 85||1.9|-3.4|0.5793
73971858|NCT04909801|147483971|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.5||||0.2883|TWO_SIDED|95.0|-4.2|1.2|||longitudinal|||Day 113||1.2|-4.2|0.2883
73971859|NCT04909801|147483971|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.7||||0.1285|TWO_SIDED|95.0|-3.9|0.5|||longitudinal|||Day 141||0.5|-3.9|0.1285
73971860|NCT04909801|147483971|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.5||||0.2815|TWO_SIDED|95.0|-4.2|1.2|||longitudinal|||Day 169||1.2|-4.2|0.2815
73971861|NCT04909801|147483976|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.3||||0.0099|TWO_SIDED|95.0|0.1|0.5|||longitudinal|||Day 29||0.5|0.1|0.0099
73971862|NCT04909801|147483976|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.1519|TWO_SIDED|95.0|-0.1|0.4|||longitudinal|||Day 57||0.4|-0.1|0.1519
73971863|NCT04909801|147483976|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.1||||0.2505|TWO_SIDED|95.0|-0.1|0.4|||longitudinal|||Day 85||0.4|-0.1|0.2505
73971864|NCT04909801|147483976|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.5248|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 113||0.2|-0.3|0.5248
73971865|NCT04909801|147483976|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.1778|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 141||0.2|-0.3|0.1778
73971866|NCT04909801|147483976|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.851|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 169||0.2|-0.3|0.8510
73971867|NCT04909801|147483977|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.3||||0.2319|TWO_SIDED|95.0|-0.9|3.5|||longitudinal|||Day 29||3.5|-0.9|0.2319
73971868|NCT04909801|147483977|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.5572|TWO_SIDED|95.0|-1.5|2.7|||longitudinal|||Day 57||2.7|-1.5|0.5572
73971869|NCT04909801|147483977|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.1||||0.9366|TWO_SIDED|95.0|-2.0|2.1|||longitudinal|||Day 85||2.1|-2.0|0.9366
73971870|NCT04909801|147483977|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.1508|TWO_SIDED|95.0|-3.5|1.0|||longitudinal|||Day 113||1.0|-3.5|0.1508
73971871|NCT04909801|147483977|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.9||||0.0303|TWO_SIDED|95.0|-3.6|-0.2|||longitudinal|||Day 141||-0.2|-3.6|0.0303
73971872|NCT04909801|147483977|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.2333|TWO_SIDED|95.0|-3.3|0.8|||longitudinal|||Day 169||0.8|-3.3|0.2333
73971873|NCT04909801|147483978|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.9||||0.0938|TWO_SIDED|95.0|-0.3|4.2|||longitudinal|||Day 29||4.2|-0.3|0.0938
73971874|NCT04909801|147483978|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.6053|TWO_SIDED|95.0|-1.6|2.7|||longitudinal|||Day 57||2.7|-1.6|0.6053
73971875|NCT04909801|147483978|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.857|TWO_SIDED|95.0|-1.9|2.3|||longitudinal|||Day 85||2.3|-1.9|0.8570
73971876|NCT04909801|147483978|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.1592|TWO_SIDED|95.0|-3.0|0.5|||longitudinal|||Day 113||0.5|-3.0|0.1592
73971877|NCT04909801|147483978|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.9||||0.0319|TWO_SIDED|95.0|-3.7|-0.2|||longitudinal|||Day 141||-0.2|-3.7|0.0319
73971878|NCT04909801|147483978|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.3||||0.2059|TWO_SIDED|95.0|-3.4|0.7|||longitudinal|||Day 169||0.7|-3.4|0.2059
73971879|NCT05274074|147484038|SUPERIORITY||Mean Difference (Net)|1.4||||0.57|TWO_SIDED|95.0|-3.4|6.2|||Regression, Linear|||||6.2|-3.4|0.57
73971880|NCT05274074|147484039|SUPERIORITY||Mean Difference (Net)|-0.1||||0.53|TWO_SIDED|95.0|-0.5|0.2|||Regression, Linear|||||0.2|-0.5|0.53
73865305|NCT03268941|147276733|OTHER||LS Mean Difference|11.24|||<|0.001|TWO_SIDED|95.0|5.91|21.41||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||21.41|5.91|<0.001
73933167|NCT00274716|147396219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|2.5||0.001|TWO_SIDED|95.0|-13.3|-3.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-3.4|-13.3|0.001
73933168|NCT00274716|147396219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|2.5||0.018|TWO_SIDED|95.0|-11.1|-1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-1.1|-11.1|0.018
73933169|NCT00274716|147396220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|9.0||0.587|TWO_SIDED|95.0|-12.9|22.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||22.8|-12.9|0.587
73933170|NCT00274716|147396220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|9.2||0.562|TWO_SIDED|95.0|-23.5|12.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||12.8|-23.5|0.562
73933171|NCT00274716|147396220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|9.2||0.802|TWO_SIDED|95.0|-15.8|20.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||20.4|-15.8|0.802
73933172|NCT00274716|147396220|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|9.0||0.772|TWO_SIDED|95.0|-15.2|20.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||20.5|-15.2|0.772
73933173|NCT00274716|147396220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|9.2||0.409|TWO_SIDED|95.0|-25.9|10.6|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||10.6|-25.9|0.409
73933174|NCT01162005|147396225|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
73971881|NCT05274074|147484040|SUPERIORITY||Mean Difference (Net)|-1.0||||0.41|TWO_SIDED|95.0|-3.3|1.4|||Regression, Linear|||||1.4|-3.3|0.41
73971882|NCT05274074|147484041|SUPERIORITY||Mean Difference (Net)|-0.9||||0.45|TWO_SIDED|95.0|-3.5|1.6|||Regression, Linear|||||1.6|-3.5|0.45
73971883|NCT05274074|147484042|SUPERIORITY||Mean Difference (Net)|3.3||||0.02|TWO_SIDED|95.0|0.5|6.2|||Regression, Linear|||||6.2|0.5|0.02
73933175|NCT00982319|147396227|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
73971884|NCT05274074|147484043|SUPERIORITY||Mean Difference (Net)|-0.8||||0.69|TWO_SIDED|95.0|-4.9|3.3|||Regression, Linear|||||3.3|-4.9|0.69
73971885|NCT04568434|147484054|SUPERIORITY||LS mean difference|-43.5|||=|0.0009|TWO_SIDED|95.0|-69.085|-17.921||ANCOVA model included effects of treatment (olezarsen 80 mg, olezarsen 50 mg, or placebo): dependent variable, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-17.921|-69.085|=0.0009
73971886|NCT04568434|147484054|SUPERIORITY||Least squares (LS) mean difference|-22.37|||=|0.0775|TWO_SIDED|95.0|-47.2|2.463||Analysis of covariance (ANCOVA) model included effects of treatment (olezarsen 80 mg, olezarsen 50 mg, or placebo): dependent variable, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||2.463|-47.200|=0.0775
73971887|NCT04568434|147484055|SUPERIORITY||LS mean difference|-43.81|||=|0.0044|TWO_SIDED|95.0|-73.928|-13.692||ANCOVA model included percent change from baseline in fasting TG at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-13.692|-73.928|=0.0044
73933176|NCT01694706|147396229|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|120.35|STANDARD_DEVIATION|23.2||0.342|TWO_SIDED|90.0|102.09|141.88|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||141.88|102.09|0.3420
73933177|NCT01694706|147396229|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.33|STANDARD_DEVIATION|30.8||0.0962|TWO_SIDED|90.0|76.21|116.76|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||116.76|76.21|0.0962
73933178|NCT01694706|147396230|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|118.79|STANDARD_DEVIATION|52.4||0.3993|TWO_SIDED|90.0|83.19|169.628|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||169.628|83.190|0.3993
73933179|NCT01694706|147396230|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|93.55|STANDARD_DEVIATION|53.0||0.2204|TWO_SIDED|90.0|65.783|133.03|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||133.030|65.783|0.2204
73933180|NCT01694706|147396231|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|121.28|STANDARD_DEVIATION|24.0||0.3765|TWO_SIDED|90.0|102.32|143.74|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||143.74|102.32|0.3765
73971888|NCT04568434|147484055|SUPERIORITY||LS mean difference|-59.39|||=|0.0002|TWO_SIDED|95.0|-90.663|-28.119||ANCOVA model included percent change from baseline in fasting TG at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-28.119|-90.663|=0.0002
73971889|NCT04568434|147484056|SUPERIORITY||LS mean difference|-65.48|||<|0.0001|TWO_SIDED|95.0|-82.634|-48.32||ANCOVA model included percent change from baseline in fasting apoC-III at Month 6: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 6||-48.320|-82.634|<0.0001
73971890|NCT04568434|147484056|SUPERIORITY||LS mean difference|-73.69|||<|0.0001|TWO_SIDED|95.0|-94.553|-52.837||ANCOVA model included percent change from baseline in fasting apoC-III at Month 6: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 6||-52.837|-94.553|<0.0001
73971891|NCT04568434|147484056|SUPERIORITY||Ls mean difference|-77.06|||<|0.0001|TWO_SIDED|95.0|-98.938|-55.177||ANCOVA model included percent change from baseline in fasting apoC-III at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-55.177|-98.938|<0.0001
73971892|NCT04568434|147484056|SUPERIORITY||LS mean difference|-81.28|||<|0.0001|TWO_SIDED|95.0|-104.656|-57.894||ANCOVA model included percent change from baseline in fasting apoC-III at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-57.894|-104.656|<0.0001
73971893|NCT04568434|147484058|SUPERIORITY||LS mean difference|-33.29|||=|0.186|TWO_SIDED|95.0|-82.612|16.041||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change From Baseline at Month 6||16.041|-82.612|=0.1860
73971894|NCT04568434|147484058|SUPERIORITY||LS mean difference|-83.97|||=|0.0019|TWO_SIDED|95.0|-136.949|-30.982||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change From Baseline at Month 6||-30.982|-136.949|=0.0019
73971895|NCT04568434|147484058|SUPERIORITY||LS mean difference|-32.9|||=|0.4219|TWO_SIDED|95.0|-113.254|47.459||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||47.459|-113.254|=0.4219
73971896|NCT04568434|147484058|SUPERIORITY||LS mean difference|-75.63|||=|0.056|TWO_SIDED|95.0|-153.195|1.927||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||1.927|-153.195|=0.0560
73971897|NCT04568434|147484059|SUPERIORITY||LS mean difference|-17.69|||=|0.0401|TWO_SIDED|95.0|-34.571|-0.801||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline Month 6||-0.801|-34.571|=0.0401
73971898|NCT04568434|147484059|SUPERIORITY||LS mean difference|-24.2|||=|0.0036|TWO_SIDED|95.0|-40.484|-7.911||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate|ANCOVA|||Percent Change from Baseline Month 6||-7.911|-40.484|=0.0036
73971899|NCT04568434|147484059|SUPERIORITY||LS mean difference|-29.84|||=|0.0134|TWO_SIDED|95.0|-53.49|-6.198||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-6.198|-53.490|=0.0134
74088789|NCT03135899|147730613|OTHER||Hazard Ratio (HR)|2.08|||||TWO_SIDED|95.0|1.22|3.53|||Regression, Cox||BI 443651 400 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||3.53|1.22|
74091644|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|3.79|||||TWO_SIDED|95.0|1.88|7.67|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 16F||7.67|1.88|
73865306|NCT03268941|147276733|OTHER||LS Mean Difference|12.8|||<|0.001|TWO_SIDED|95.0|6.94|23.59||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration - covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||23.59|6.94|<0.001
73865307|NCT03268941|147276734|OTHER||LS Mean Difference|7.76|STANDARD_ERROR_OF_MEAN|14.648||0.599|TWO_SIDED|95.0|-21.89|37.41||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||37.41|-21.89|0.599
73865308|NCT03268941|147276734|OTHER||LS Mean Difference|6.28|STANDARD_ERROR_OF_MEAN|15.469||0.687|TWO_SIDED|95.0|-25.04|37.59||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||37.59|-25.04|0.687
73865309|NCT03268941|147276734|OTHER||LS Mean Difference|8.05|STANDARD_ERROR_OF_MEAN|15.45||0.605|TWO_SIDED|95.0|-23.22|39.33||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||39.33|-23.22|0.605
73865310|NCT03268941|147276735|OTHER||LS Mean Difference|7.56|STANDARD_ERROR_OF_MEAN|11.708||0.522|TWO_SIDED|95.0|-16.06|31.19||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||31.19|-16.06|0.522
73865311|NCT03268941|147276735|OTHER||LS Mean Difference|12.92|STANDARD_ERROR_OF_MEAN|12.143||0.293|TWO_SIDED|95.0|-11.58|37.43||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||37.43|-11.58|0.293
73865312|NCT03268941|147276735|OTHER||LS Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|11.654||0.551|TWO_SIDED|95.0|-16.52|30.52||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||30.52|-16.52|0.551
74030399|NCT02078713|147615149|SUPERIORITY||Odds Ratio (OR)|0.89||||0.46|TWO_SIDED|95.0|0.65|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.22|0.65|0.46
74030400|NCT02078713|147615149|SUPERIORITY||Odds Ratio (OR)|0.79||||0.16|TWO_SIDED|95.0|0.57|1.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.10|0.57|0.16
74030401|NCT02078713|147615150|SUPERIORITY||Odds Ratio (OR)|1.45||||0.03|TWO_SIDED|95.0|1.03|2.05||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||2.05|1.03|0.03
74030402|NCT02078713|147615151|SUPERIORITY||Odds Ratio (OR)|1.61||||0.01|TWO_SIDED|95.0|1.11|2.33||P-value calculated in imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||2.33|1.11|0.01
74030403|NCT02078713|147615152|SUPERIORITY||Odds Ratio (OR)|1.11||||0.62|TWO_SIDED|95.0|0.74|1.67||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.67|0.74|0.62
74030404|NCT02078713|147615153|SUPERIORITY||Relative risk ratio|1.1||||0.85|TWO_SIDED|95.0|0.4|3.04||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had been less involved to right amount (ref)||3.04|0.40|0.85
74030405|NCT02078713|147615153|SUPERIORITY||Relative risk ratio|1.6||||0.24|TWO_SIDED|95.0|0.73|3.5||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished their providers had been more involved, compared to right amount (ref)||3.50|0.73|0.24
74030406|NCT02078713|147615154|SUPERIORITY||Relative risk ratio|1.0||||0.997|TWO_SIDED|95.0|0.45|2.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had expressed preference less strongly to right amount (ref).||2.25|0.45|0.997
74030407|NCT02078713|147615154|SUPERIORITY||Relative risk ratio|0.69||||0.16|TWO_SIDED|95.0|0.41|1.16||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished provider had expressed preference more strongly, compared to right amount (ref).||1.16|0.41|0.16
74030408|NCT02078713|147615155|SUPERIORITY|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|Odds Ratio (OR)|1.3||||0.13|TWO_SIDED|95.0|0.93|1.82||P-value calculated in multiply imputed dataset.|Regression, Logistic||The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.82|0.93|0.13
74030409|NCT02078713|147615156|SUPERIORITY||Relative risk ratio|1.13||||0.5|TWO_SIDED|95.0|0.79|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patient decision to both (ref)||1.61|0.79|0.50
74030410|NCT02078713|147615156|SUPERIORITY||Relative risk ratio|2.14||||0.09|TWO_SIDED|95.0|0.89|5.15||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of provider decision to both (ref)||5.15|0.89|0.09
73865313|NCT03268941|147276736|OTHER||Hodges-Lehmann Estimate of Median Diff|-18.14||||0.274|TWO_SIDED|95.0|-307.58|13.56||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.||13.56|-307.58|0.274
73933181|NCT01694706|147396231|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.72|STANDARD_DEVIATION|31.4||0.0946|TWO_SIDED|90.0|76.25|117.67|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||117.67|76.25|0.0946
73933182|NCT03779997|147396246|SUPERIORITY||Risk Ratio (RR)|0.78|STANDARD_DEVIATION|0.1||0.07|TWO_SIDED|95.0|0.6|1.02||0.05 a priori threshold for statistical significance.|Log-linear GEE regression|||Null hypothesis: no difference in the percentage of urine drug tests (UDT) negative for opioids between the two treatment arms.Treatment-as-usual (TAU) is the reference group.||1.02|0.60|0.07
73933183|NCT03779997|147396247|SUPERIORITY||Risk Ratio (RR)|0.84|STANDARD_DEVIATION|0.11||0.2|TWO_SIDED|95.0|0.65|1.1||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs|||Null hypothesis: no difference between treatment arms in the percentage of patients engaged in treatment at week 12. TAU is the reference group.||1.10|0.65|0.20
73933184|NCT03779997|147396248|SUPERIORITY||Risk Ratio (RR)|0.73|STANDARD_DEVIATION|0.17||0.18|TWO_SIDED|95.0|0.45|1.16||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs|||Null hypothesis: No difference between arms in the percentage of participants engaged in treatment at week 24 post-randomization. TAU is the reference group.||1.16|0.45|0.18
73933185|NCT03779997|147396249|SUPERIORITY||Median Difference (Final Values)|0.9|STANDARD_DEVIATION|0.45||0.31|TWO_SIDED|95.0|-0.9|2.7||0.05 a priori threshold for statistical significance.|t-test, 2 sided||TAU is the reference group.|Null hypothesis: No difference between arms on the number of consecutive weeks with UDT negative for opioids.||2.7|-0.9|0.31
73933186|NCT03779997|147396250|SUPERIORITY||Risk Ratio (RR)|0.71|STANDARD_DEVIATION|0.41||0.57|TWO_SIDED|95.0|0.23|2.26||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in the number of participants who self-reported illicit opioid use at week 12.||2.26|0.23|0.57
73933187|NCT03779997|147396251|SUPERIORITY||Risk Ratio (RR)|1.01|STANDARD_DEVIATION|0.066||0.88|TWO_SIDED|95.0|0.89|1.15||0.05 a priori threshold for statistical significance.|GEE Poisson regression||TAU is the reference group.|Null hypothesis: No difference between arms in the mean number of days adherent to buprenorphine by self-report.||1.15|0.89|0.88
73933188|NCT03779997|147396253|SUPERIORITY||Risk Ratio (RR)|1.17|STANDARD_DEVIATION|0.6||0.77|TWO_SIDED|95.0|0.42|3.24||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in number of participants who had one or more urine drug tests negative for buprenorphine.||3.24|0.42|0.77
73933189|NCT03779997|147396254|SUPERIORITY||Risk Ratio (RR)|0.67|STANDARD_DEVIATION|0.26||0.3|TWO_SIDED|95.0|0.32|1.43||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in number of participants who tested positive for stimulants at week 12.||1.43|0.32|0.30
73933190|NCT03779997|147396255|SUPERIORITY||Median Difference (Final Values)|0.02|STANDARD_DEVIATION|0.07||0.91|TWO_SIDED|95.0|-0.29|0.32||0.05 a priori threshold for statistical significance|t-test, 2 sided||TAU is the reference group|Null hypothesis: No difference between arms in mean treatment satisfaction scores||0.32|-0.29|0.91
73933191|NCT03264157|147396274|NON_INFERIORITY|The null hypothesis is p-p0 ≤ -0.1. The alternative hypothesis is p-p0 \> -0.1, where p is the proportion of subjects with anti-rabies titer of \>0.5 IU/mL at Day 14 in subjects receiving BPL HRIG + vaccine and p0 is the proportion receiving comparator HRIG + vaccine. We reject the null hypothesis at the one-sided 0.025 significance level, and conclude that p-p0 \> -0.1, if the lower bound of an exact 95% binomial confidence interval exceeds -0.1.|lower 95% CI|-0.05||||0.0006|ONE_SIDED|95.0|-0.05|||The threshold for this test is \<=0.025.|Farrington and Manning test||||||-0.05|0.0006
73933192|NCT03264157|147396275|NON_INFERIORITY|The prespecified non inferiority margin was 20%. The lower bound of the 95% CI required should be greater than 0.8 to conclude non-inferiority.|lower 95% CI|0.74|||||TWO_SIDED|95.0|0.74|0.94||||||||0.94|0.74|
73933193|NCT03264157|147396276|SUPERIORITY||95% CI|0.97|||||TWO_SIDED||||||||Data analyzed as log normal. The value presented is the untransformed value of the difference between means.|||||
74088790|NCT03135899|147730613|OTHER||Hazard Ratio (HR)|2.59|||||TWO_SIDED|95.0|1.5|4.47|||Regression, Cox||BI 443651 1200 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||4.47|1.50|
73933194|NCT03264157|147396277|NON_INFERIORITY|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|-0.05||||0.0006|TWO_SIDED|95.0|-0.05|0.1|||Farrington and Manning test|||||0.10|-0.05|0.0006
73933195|NCT03264157|147396278|NON_INFERIORITY|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|0.0||||0|TWO_SIDED|95.0|0.0|0.0|||Farrington and Manning test||For Day 14, all subjects achieved the endpoint (RVNA titer \> LLOQ). Since the statistic to measure the performance is a proportion, the proportion is 1 and no variance is calculable.|||0|0|0
73933196|NCT02710630|147396292|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|119.33|STANDARD_DEVIATION|40.4|||TWO_SIDED|90.0|101.838|139.834|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||139.834|101.838|
73933197|NCT02710630|147396292|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|52.97|STANDARD_DEVIATION|168.9|||TWO_SIDED|90.0|33.341|84.158|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||84.158|33.341|
74088791|NCT03660241|147730614|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|138.49|||||TWO_SIDED|90.0|93.74|204.61|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group.||204.61|93.74|
74088792|NCT03660241|147730614|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|99.11|||||TWO_SIDED|90.0|57.3|171.43|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||171.43|57.30|
73865314|NCT03268941|147276736|OTHER||Hodges-Lehmann Estimate of Median Diff|-26.95||||0.481|TWO_SIDED|95.0|-229.73|530.49||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.||530.49|-229.73|0.481
73865315|NCT03268941|147276736|OTHER||Hodges-Lehmann Estimate of Median Diff|-24.49||||0.382|TWO_SIDED|95.0|-225.87|98.91||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE on time measured by the SmartPill Day 7 in Part 1.||98.91|-225.87|0.382
73865316|NCT01216683|147276741|SUPERIORITY|||||||0.02||||||one-sided p-value|Cochran-Mantel-Haenszel|||The study was designed to detect a 16% difference in CR rate from 50% in the Bendamustine + Rituximab arms to 66% in the Bendamustine + Rituximab + Bortezomib arm, with 90% power at the one-sided alpha 0.15 level.||||0.02
73865317|NCT01216683|147276742|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified on Groupe d'Etude des Lymphomes Folliculaires status and Follicular Lymphoma International Prognostic Index||||||0.02
73865318|NCT00757822|147276792|SUPERIORITY_OR_OTHER||Difference in Percentages|4.6|||>|0.76|TWO_SIDED|90.0|-9.5|18.6|||Fisher Exact|||The incidence of PON per arm will be determined and expressed as a percentage of the total patients per arm. Treatment efficacy will be measured as the percentage-point decrease in PON in the treatment arm (Marinol) compared to the standard therapy arm (ondansetron). Null hypothesis: Marinol treatment is not superior to ondansetron treatment. We will test the statistical significance with Fisher's Exact test at a significance level of 0.05||18.6|-9.5|>0.76
73933198|NCT02710630|147396292|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|59.01|STANDARD_DEVIATION|73.4|||TWO_SIDED|90.0|45.255|76.955|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||76.955|45.255|
74030411|NCT02078713|147615157|SUPERIORITY||Odds Ratio (OR)|1.27||||0.12|TWO_SIDED|95.0|0.94|1.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.71|0.94|0.12
73865319|NCT00757822|147276793|SUPERIORITY_OR_OTHER||||||>|0.92|||||||Fisher Exact|One-sided Fisher's Exact test was performed comparing the percentage of subjects with at least one VAS score \> 0. (Marinol\>Ondansetron).||||||>0.92
73865320|NCT00757822|147276794|SUPERIORITY_OR_OTHER||Difference in Percentages|7.7|||>|0.55|TWO_SIDED|90.0|-12.1|13.3|||Fisher Exact|||||13.3|-12.1|>0.55
74030412|NCT02078713|147615158|SUPERIORITY||Odds Ratio (OR)|1.18||||0.41|TWO_SIDED|95.0|0.8|1.74||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of overall score||1.74|0.80|0.41
74088793|NCT03660241|147730615|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|182.91|||||TWO_SIDED|90.0|117.09|285.71|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||285.71|117.09|
74088794|NCT03660241|147730615|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|121.32|||||TWO_SIDED|90.0|68.32|215.41|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||215.41|68.32|
73865321|NCT00757822|147276795|SUPERIORITY_OR_OTHER||||||=|0.981|TWO_SIDED||||||Wilcoxon Rank-Sum test|||||||=0.981
73865322|NCT00757822|147276796|SUPERIORITY_OR_OTHER||||||>|0.9|||||||Fisher Exact|||||||>0.90
73865323|NCT00757822|147276797|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Fisher Exact|||||||>0.37
73865324|NCT00757822|147276798|SUPERIORITY_OR_OTHER||||||>|0.75|TWO_SIDED||||||FREQ Procedure|||Comparisons at 24-48 hr post-surgery. Null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction.||||>0.75
73865325|NCT00757822|147276798|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||FREQ procedure|||Comparisons of both arms at 2-6 weeks; null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction||||>0.10
73865326|NCT00757822|147276799|SUPERIORITY_OR_OTHER||||||>|0.29|TWO_SIDED||||||FREQ procedure|||Comparison of both group responses at 24-48 hours.||||>0.29
73865327|NCT00757822|147276799|SUPERIORITY_OR_OTHER||||||>|0.55|TWO_SIDED||||||FREQ Procedure|||Comparisons of both arms at 2-6 weeks.||||>0.55
73865328|NCT02814175|147276812|OTHER|Between group difference|point estimate difference|28.3|||<|0.001|TWO_SIDED|95.0|17.8|38.9|||Cochran-Mantel-Haenszel|Adjusted for the stratification factor which is the duration of prior MTX 15 mg ew use of ≤ 3 months or \> 3 months.||||38.9|17.8|< 0.001
73865329|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.17||||1|TWO_SIDED|95.0|0.083|0.359|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.359|0.083|1.000
73865330|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.23||||0.9999|TWO_SIDED|95.0|0.111|0.492|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.492|0.111|0.9999
73865331|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.26||||0.9997|TWO_SIDED|95.0|0.121|0.568|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.568|0.121|0.9997
73865332|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9997|TWO_SIDED|95.0|0.136|0.66|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.660|0.136|0.9997
73865333|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.133|0.632|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.632|0.133|0.9991
73865334|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.46||||0.9631|TWO_SIDED|95.0|0.213|1.081|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.081|0.213|0.9631
73865335|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.33||||0.9941||95.0|0.157|0.789|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.789|0.157|0.9941
74088795|NCT03660241|147730616|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|99.51|||||TWO_SIDED|90.0|59.8|165.57|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||165.57|59.80|
73865336|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.38||||0.9875|TWO_SIDED|95.0|0.179|0.891|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.891|0.179|0.9875
73933199|NCT02710630|147396292|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|108.21|STANDARD_DEVIATION|55.7|||TWO_SIDED|90.0|87.698|133.53|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||133.530|87.698|
73933200|NCT02710630|147396292|SUPERIORITY_OR_OTHER||Ratio|110.21|STANDARD_DEVIATION|41.1|||TWO_SIDED|90.0|93.939|129.297|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||129.297|93.939|
73933201|NCT02710630|147396293|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|118.31|STANDARD_DEVIATION|44.2|||TWO_SIDED|90.0|99.569|140.579|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||140.579|99.569|
73933202|NCT02710630|147396293|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|57.49|STANDARD_DEVIATION|132.3|||TWO_SIDED|90.0|38.502|85.837|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||85.837|38.502|
73933203|NCT02710630|147396293|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|61.94|STANDARD_DEVIATION|69.0|||TWO_SIDED|90.0|48.13|79.72|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||79.720|48.130|
73933204|NCT02710630|147396293|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|108.26|STANDARD_DEVIATION|55.8|||TWO_SIDED|90.0|87.704|133.629|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||133.629|87.704|
73933205|NCT02710630|147396293|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.76|STANDARD_DEVIATION|43.0|||TWO_SIDED|90.0|91.238|127.281|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||127.281|91.238|
73933206|NCT02710630|147396294|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|118.26|STANDARD_DEVIATION|38.5|||TWO_SIDED|90.0|101.627|137.621|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||137.621|101.627|
73933207|NCT02710630|147396294|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|87.26|STANDARD_DEVIATION|60.2|||TWO_SIDED|90.0|69.404|109.722|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||109.722|69.404|
73933208|NCT02710630|147396294|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|71.4|STANDARD_DEVIATION|49.2|||TWO_SIDED|90.0|58.828|86.648|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||86.648|58.828|
73933209|NCT02710630|147396294|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|116.67|STANDARD_DEVIATION|37.7|||TWO_SIDED|90.0|100.516|135.41|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||135.410|100.516|
73933210|NCT02710630|147396294|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|109.85|STANDARD_DEVIATION|38.7|||TWO_SIDED|90.0|94.452|127.75|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||127.750|94.452|
73865337|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.33||||0.9956|TWO_SIDED|95.0|0.151|0.759|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.759|0.151|0.9956
73865338|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9964|TWO_SIDED|95.0|0.157|0.747|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.747|0.157|0.9964
73933211|NCT02710630|147396295|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.69|STANDARD_DEVIATION|40.2|||TWO_SIDED|90.0|98.783|135.491|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||135.491|98.783|
73933212|NCT02710630|147396295|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|50.43|STANDARD_DEVIATION|173.7|||TWO_SIDED|90.0|31.519|80.689|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||80.689|31.519|
73933213|NCT02710630|147396295|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|56.71|STANDARD_DEVIATION|74.2|||TWO_SIDED|90.0|43.388|74.122|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||74.122|43.388|
73971900|NCT04568434|147484059|SUPERIORITY||LS mean difference|-39.7|||=|0.0009|TWO_SIDED|95.0|-63.108|-16.292||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-16.292|-63.108|=0.0009
73971901|NCT04568434|147484060|SUPERIORITY||Mean Rate Ratio|0.1|||=|0.0052|TWO_SIDED|95.0|0.02|0.506||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable.|Negative Binomial Regression Model|||||0.506|0.020|=0.0052
74088796|NCT03660241|147730616|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|167.79|||||TWO_SIDED|90.0|97.2|289.64|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||289.64|97.20|
73933214|NCT02710630|147396295|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.99|STANDARD_DEVIATION|52.8|||TWO_SIDED|90.0|87.554|130.732|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||130.732|87.554|
73933215|NCT02710630|147396295|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.07|STANDARD_DEVIATION|40.7|||TWO_SIDED|90.0|91.399|125.432|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||125.432|91.399|
73933216|NCT02710630|147396296|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.39|STANDARD_DEVIATION|45.3|||TWO_SIDED|90.0|96.74|137.644|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||137.644|96.740|
73933217|NCT02710630|147396296|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|54.12|STANDARD_DEVIATION|138.6|||TWO_SIDED|90.0|35.818|81.774|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||81.774|35.818|
73933218|NCT02710630|147396296|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|58.96|STANDARD_DEVIATION|71.4|||TWO_SIDED|90.0|45.489|76.431|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||76.431|45.489|
73933219|NCT02710630|147396296|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.38|STANDARD_DEVIATION|57.0|||TWO_SIDED|90.0|85.846|131.836|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||131.836|85.846|
73933220|NCT02710630|147396296|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|103.73|STANDARD_DEVIATION|43.3|||TWO_SIDED|90.0|87.74|122.628|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||122.628|87.740|
73933221|NCT02710630|147396297|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.27|STANDARD_DEVIATION|38.4|||TWO_SIDED|90.0|99.063|134.13|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||134.130|99.063|
73933222|NCT02710630|147396297|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|83.73|STANDARD_DEVIATION|62.8|||TWO_SIDED|90.0|66.033|106.163|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||106.163|66.033|
73971902|NCT04568434|147484061|SUPERIORITY||Mean Rate Ratio|0.12|||=|0.0144|TWO_SIDED|95.0|0.022|0.656||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable.|Negative Binomial Regression Model|||||0.656|0.022|=0.0144
73971903|NCT04568434|147484062|SUPERIORITY||Mean Rate Ratio|0.14|||=|0.0174|TWO_SIDED|95.0|0.028|0.709||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.709|0.028|=0.0174
73971904|NCT04568434|147484063|SUPERIORITY||Mean Rate Ratio|0.16|||=|0.0314|TWO_SIDED|95.0|0.031|0.85||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.850|0.031|=0.0314
73971905|NCT04568434|147484066|SUPERIORITY||Mean Rate Ratio|0.14|||=|0.0137|TWO_SIDED|95.0|0.029|0.669||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable|Negative Binomial Regression Model|||||0.669|0.029|=0.0137
73971906|NCT04568434|147484067|SUPERIORITY||Mean Rate Ratio|0.2|||=|0.048|TWO_SIDED|95.0|0.04|0.986||Regression model:treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.986|0.040|=0.0480
73933223|NCT02710630|147396297|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|68.77|STANDARD_DEVIATION|50.3|||TWO_SIDED|90.0|56.452|83.782|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||83.782|56.452|
73971907|NCT05469464|147484069|SUPERIORITY||Mean Difference (Net)|-4.6|STANDARD_ERROR_OF_MEAN|6.93||0.505|TWO_SIDED|95.0|-18.2|9.0|||ANCOVA|||||9.0|-18.2|0.505
73971908|NCT05469464|147484069|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|7.15||0.812|TWO_SIDED|95.0|-15.8|12.3|||ANCOVA|||||12.3|-15.8|0.812
73971909|NCT05469464|147484069|SUPERIORITY||Mean Difference (Net)|-10.9|STANDARD_ERROR_OF_MEAN|6.99||0.118|TWO_SIDED|95.0|-24.6|2.8|||ANCOVA|||||2.8|-24.6|0.118
73971910|NCT05485779|147484125|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.17||||0.6358|TWO_SIDED|95.0|1.07|1.27|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 30.4. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.27|1.07|0.6358
73865339|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9999|TWO_SIDED|95.0|0.114|0.532|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.532|0.114|0.9999
73933224|NCT02710630|147396297|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.13|STANDARD_DEVIATION|49.6|||TWO_SIDED|90.0|88.616|129.51|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||129.510|88.616|
73933225|NCT02710630|147396297|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.64|STANDARD_DEVIATION|38.9|||TWO_SIDED|90.0|91.625|124.114|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||124.114|91.625|
73933226|NCT03224468|147396319|SUPERIORITY|Power was determined to be 85.2% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.15|0.4||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.40|0.15|<0.001
73933227|NCT03224468|147396320|SUPERIORITY|Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.45||0.5|TWO_SIDED|95.0|-1.4|0.4||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in scale score for MM above and beyond WLC (positive values denote higher score for MM).|The mean difference in scale scores between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's scale scores at baseline.||0.4|-1.4|0.50
73933228|NCT03224468|147396321|SUPERIORITY|Power was determined to be 84.3% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.5||0.9|TWO_SIDED|95.0|-0.3|0.24||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.24|-0.30|0.90
73933229|NCT03224468|147396322|SUPERIORITY|Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.5||0.93|TWO_SIDED|95.0|-0.38|0.39||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.39|-0.38|0.93
73957814|NCT01726023|147451084|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority would be concluded if the lower limit of the 95% confidence interval (CI; corresponding to a 97.5% 1 sided lower bound) was greater than -12.5% for the primary outcome variable.|Risk Difference (RD)|-0.2|||<|0.001|TWO_SIDED|95.0|-5.53|4.97||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff ≤ -12.5%.|% Risk Difference (RD)|RD is CAZ AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|units for RD are %|The Primary objective of this study was to assess the non inferiority (based on a 12.5% margin) of CAZ AVI plus metronidazole compared to meropenem alone with respect to clinical cure at the TOC visit in patients who were CE.||4.97|-5.53|<0.001
74088797|NCT03660241|147730617|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|154.22|||||TWO_SIDED|90.0|105.11|226.26|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||226.26|105.11|
74088798|NCT03660241|147730617|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|287.06|||||TWO_SIDED|90.0|196.72|418.89|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||418.89|196.72|
74088799|NCT03660241|147730618|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|137.43|||||TWO_SIDED|90.0|106.82|176.81|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||176.81|106.82|
73957815|NCT01726023|147451117|SUPERIORITY_OR_OTHER||Difference in median time (days)|0.5||||0.773|||||||Log Rank|||||||0.773
73957816|NCT01726023|147451118|SUPERIORITY_OR_OTHER||Difference in median time (days)|1.0||||0.598|||||||Log Rank|||||||0.598
73957817|NCT03068468|147451188|SUPERIORITY||Difference|-0.2||||0.8483|TWO_SIDED|95.0|-2.0|1.6|||Mixed model for repeated measures (MMRM)|||28-item:Adjusted mean for each treatment group, difference with Placebo,95% confidence interval and p-value at each time point were based on a mixed model for repeated measures model (MMRM), with change from baseline in 28-item PSPRS total score as dependent variable and with fixed effects of treatment group, time(categorical), treatment group-by-time interaction, baseline 28-item PSPRS, baseline 28-item PSPRS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.6|-2.0|0.8483
73957818|NCT03068468|147451188|SUPERIORITY||Difference|-0.28||||0.6503|TWO_SIDED|95.0|-1.5|0.94|||MMRM|||15-items:Adjusted mean for each treatment group, difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in 15-item PSPRS total score as dependent variable and with fixed effects of treatment group, time(categorical), treatment groupby-time interaction, baseline 15-item PSPRS, baseline 15-item PSPRS by time interaction, baseline Color Trails 2 test(\<=170 or \>170 seconds) and region.||0.94|-1.50|0.6503
73957819|NCT03068468|147451190|SUPERIORITY||Difference|0.4||||0.6031|TWO_SIDED|95.0|-1.0|1.7|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MDS-UPDRS as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline MDS-UPDRS, baseline MDS-UPDRS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.7|-1.0|0.6031
73957820|NCT03068468|147451191|SUPERIORITY||Difference|0.0||||0.7743|TWO_SIDED|95.0|-0.2|0.1|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with CGI-C as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline CGI-S, baseline CGI-S by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.1|-0.2|0.7743
73957821|NCT03068468|147451192|SUPERIORITY||Difference|0.038||||0.318|TWO_SIDED|95.0|-0.036|0.112|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSP-cognitive composite battery as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline PSP-cognitive composite battery, baseline PSP-cognitive composite battery by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.112|-0.036|0.3180
73957822|NCT03068468|147451193|SUPERIORITY||Difference|-0.2||||0.827|TWO_SIDED|95.0|-1.8|1.4|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in RBANS as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline RBANS , baseline RBANS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds and region.||1.4|-1.8|0.8270
73957823|NCT03068468|147451194|SUPERIORITY||Difference|-0.2||||0.9304|TWO_SIDED|95.0|-3.6|3.3|||MMRM|||Physical scale score: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSP-QoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||3.3|-3.6|0.9304
73957824|NCT03068468|147451194|SUPERIORITY||Difference|0.5||||0.7859|TWO_SIDED|95.0|-2.8|3.7|||MMRM|||Mental scale score: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSPQoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-bytime interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||3.7|-2.8|0.7859
73957825|NCT03068468|147451194|SUPERIORITY||Difference|-1.7||||0.4297|TWO_SIDED|95.0|-5.8|2.5|||MMRM|||Satisfaction With Your Life Today: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSPQoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-bytime interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||2.5|-5.8|0.4297
73957826|NCT03068468|147451195|SUPERIORITY||Difference|2.0||||0.2084|TWO_SIDED|95.0|-1.1|5.2|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in SEADL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for SEADL , baseline SEADL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||5.2|-1.1|0.2084
73957827|NCT03068468|147451196|SUPERIORITY||Difference|0.0||||0.5701|TWO_SIDED|95.0|-0.2|0.1|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CGI-S as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for CGI-S, baseline CGI-S by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.1|-0.2|0.5701
73957828|NCT03068468|147451197|SUPERIORITY||Difference|0.9||||0.0517|TWO_SIDED|95.0|0.0|1.8|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Phonemic Fluency Test as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline Phonemic Fluency Test, baseline Phonemic Fluency Test by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.8|-0.0|0.0517
73933230|NCT03224468|147396323|SUPERIORITY|Power was determined to be 90.4% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-1.3|-0.43||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||-0.43|-1.30|<0.001
73933231|NCT03224468|147396324|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.0|2.5|||||Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's score at baseline.||2.5|-1.0|
73933232|NCT03224468|147396326|SUPERIORITY||Mean Difference (Net)|-7.7|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-19.0|3.5|||||Estimate is the mean difference in the congruency cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||3.5|-19.0|
73933233|NCT03224468|147396327|SUPERIORITY||Mean Difference (Net)|-24.1|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|95.0|-45.9|-2.2|||||Estimate is the mean difference in the switching cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||-2.2|-45.9|
73933234|NCT03224468|147396328|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|95.0|-0.007|0.011|||||Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate better ability to identify target items for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.011|-0.007|
73933235|NCT03224468|147396329|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.8|1.7|||||Estimate is the mean difference in number of total errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||1.7|-1.8|
73933236|NCT03224468|147396330|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-7.4|0.3|||||Estimate is the mean difference in number of repetition errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.3|-7.4|
73933237|NCT03224468|147396331|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.2|0.1|||||Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate a greater ability to recognize previously studied words for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.1|-0.2|
73933238|NCT03224468|147396332|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.2|1.0|||||Estimate is the mean difference in number recalled for MM above and beyond WLC (positive values indicate a greater ability to recall previously studied words for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||1.0|-0.2|
73933239|NCT02461589|147396333|OTHER||Treatment difference|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.77|||Mixed Models Analysis|||||-0.77|-1.30|<0.0001
73933240|NCT02461589|147396333|OTHER||Treatment difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.08|||Mixed Models Analysis|||||-1.08|-1.61|<0.0001
73933241|NCT02461589|147396333|OTHER||Treatment difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-1.95|-1.42|||Mixed Models Analysis|||||-1.42|-1.95|<0.0001
73933242|NCT02461589|147396333|OTHER||Treatment difference|-1.86|||<|0.0001|TWO_SIDED|95.0|-2.12|-1.6|||Mixed Models Analysis|||||-1.60|-2.12|<0.0001
73933243|NCT01038921|147396358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0||||0.013|||||||Mixed Models Analysis|||Average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those subjects were on Melatonin was compared to the average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those same subjects were on Placebo using an intent-to-treat mixed model. Power was estimated based on having 30 subjects completing both the melatonin arm and the placebo arm.||||0.013
73933244|NCT01978119|147396359|NON_INFERIORITY_OR_EQUIVALENCE|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by capsule-based unit dose DPI versus FSC administered BID by multi-dose DPI is greater than -125 milliliter (mL).|Mean Difference (Net)|0.028|||||TWO_SIDED|95.0|-0.024|0.08|||Repeated Measures Mixed Models|||||0.080|-0.024|
73933245|NCT01978119|147396360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|||||TWO_SIDED|95.0|-1.039|0.334||||||||0.334|-1.039|
73933246|NCT01978119|147396361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||||TWO_SIDED|95.0|-0.372|0.927||||||||0.927|-0.372|
73865340|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.13|0.647|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.647|0.130|0.9991
73971911|NCT05485779|147484125|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.13||||0.5506|TWO_SIDED|95.0|0.963|1.31|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 32.9. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.31|0.963|0.5506
73971912|NCT05485779|147484126|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.13||||0.3653|TWO_SIDED|95.0|1.04|1.22|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 25.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.22|1.04|0.3653
73971913|NCT05485779|147484126|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.16||||0.2933|TWO_SIDED|95.0|1.01|1.31|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 27.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.31|1.01|0.2933
73971914|NCT05485779|147484127|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.16||||0.46|TWO_SIDED|95.0|0.908|1.41|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 64.3. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.41|0.908|0.4600
73971915|NCT05485779|147484127|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.12||||0.3157|TWO_SIDED|95.0|0.795|1.45|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 65.6. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.45|0.795|0.3157
73971916|NCT05485779|147484128|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.2||||0.235|TWO_SIDED|95.0|1.02|1.37|||Lack of fit 1-sided p-value|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 54.2. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.37|1.02|0.2350
74030413|NCT02078713|147615158|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0496|TWO_SIDED|95.0|1.0|1.8|||Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of informed decision subscale||1.80|1.00|0.0496
74088800|NCT03660241|147730618|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|177.92|||||TWO_SIDED|90.0|135.91|232.92|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||232.92|135.91|
73933247|NCT01978119|147396362|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|||||TWO_SIDED|95.0|-0.074|0.088|||||Day 28 Change from Baseline Analysis|||0.088|-0.074|
73933248|NCT01978119|147396362|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.022||||||95.0|-0.049|0.092|||||Day 56 Change from Baseline Analysis|||0.092|-0.049|
73933249|NCT01978119|147396363|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.35|||||TWO_SIDED|95.0|-1.34|10.05||||||||10.05|-1.34|
73933250|NCT01978119|147396364|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.2|0.09||||||||0.09|-0.20|
73933251|NCT01978119|147396366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.25|||||TWO_SIDED|95.0|-6.97|2.46||||||||2.46|-6.97|
73933252|NCT01978119|147396367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||||0.5|-0.9|
73865341|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.36||||0.9852|TWO_SIDED|0.9852|0.137|0.906|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||0.906|0.137|0.9852
73865342|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.51||||0.9719|TWO_SIDED|95.0|0.23|1.014|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.014|0.230|0.9719
73933253|NCT01978119|147396368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-4.64|3.11||||||||3.11|-4.64|
73933254|NCT01243944|147396398|SUPERIORITY_OR_OTHER||Odds Ratio, log|32.67|||<|0.0001|TWO_SIDED|95.0|5.04|1337.0|||Exact Cochran-Mantel-Haenszel|||||1337|5.04|< 0.0001
73933255|NCT01243944|147396399|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.01|||<|0.0001|TWO_SIDED|95.0|4.24|1144.0|||Exact Cochran-Mantel-Haenszel|||||1144|4.24|<0.0001
73933256|NCT01243944|147396400|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.57||||0.0016|TWO_SIDED|95.0|1.5|9.06|||Exact Cochran-Mantel-Haenszel|P-value was calculated using stratified exact Cochran-Mantel-Haenszel test by adjusting for the WBC/platelet status (abnormal vs normal) at baseline.||||9.06|1.50|0.0016
73933257|NCT00153101|147396413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8462||95.0|0.92|1.07|||Regression, Cox|||||1.07|0.92|0.8462
73933258|NCT00153101|147396413|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was 1.13|Hazard Ratio (HR)|1.01||||0.0019||97.5|0.93|1.1|||Regression, Cox|||||1.10|0.93|0.0019
73933259|NCT00153101|147396414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9086||95.0|0.93|1.09|||Regression, Cox|||||1.09|0.93|0.9086
73933260|NCT00153101|147396414|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was 1.13|Hazard Ratio (HR)|0.99||||0.0004||97.5|0.9|1.08|||Regression, Cox|||||1.08|0.90|0.0004
73971917|NCT05485779|147484128|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.19||||0.1632|TWO_SIDED|95.0|0.88|1.5|||Lack of fit 1-sided p-value|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 58.5. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.50|0.880|0.1632
73933261|NCT00153101|147396415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.4535||95.0|0.93|1.17|||Regression, Cox|||||1.17|0.93|0.4535
73933262|NCT00153101|147396415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9421||95.0|0.89|1.12|||Regression, Cox|||||1.12|0.89|0.9421
73933263|NCT00153101|147396416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2909||95.0|0.94|1.23|||Regression, Cox|||||1.23|0.94|0.2909
73933264|NCT00153101|147396416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2534||95.0|0.94|1.24|||Regression, Cox|||||1.24|0.94|0.2534
73933265|NCT00153101|147396417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2248||95.0|0.79|1.06|||Regression, Cox|||||1.06|0.79|0.2248
73933266|NCT00153101|147396417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.1829||95.0|0.79|1.05|||Regression, Cox|||||1.05|0.79|0.1829
73933267|NCT00153101|147396418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.4984||95.0|0.82|1.1|||Regression, Cox|||||1.10|0.82|0.4984
73971918|NCT05485779|147484129|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.977|||||TWO_SIDED|90.0|0.915|1.04|||||Within-subject geometric coefficient of variation was 5.66. Data analyzed using a mixed model included treatment as a fixed effect and subject as a random effect. ln(parameter)=treatment+subject+random error, with subject fitted as a random effect.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess the Effect of Food on Single Oral Doses of 16 mg AQ280||1.04|0.915|
74088801|NCT03660241|147730619|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|269.78|||||TWO_SIDED|90.0|196.61|370.18|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||370.18|196.61|
73933268|NCT00153101|147396418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.1203||95.0|0.97|1.29|||Regression, Cox|||||1.29|0.97|0.1203
74088802|NCT03660241|147730619|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|571.43|||||TWO_SIDED|90.0|447.27|730.05|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||730.05|447.27|
73933269|NCT00153101|147396419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.4221|TWO_SIDED|95.0|0.73|2.15|||Regression, Cox|||||2.15|0.73|0.4221
73933270|NCT00153101|147396419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7305||95.0|0.51|1.6|||Regression, Cox|||||1.60|0.51|0.7305
73933271|NCT00153101|147396420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.6248||95.0|0.54|1.45|||Regression, Cox|||||1.45|0.54|0.6248
73933272|NCT00153101|147396420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0751|TWO_SIDED|95.0|0.36|1.05|||Regression, Cox|||||1.05|0.36|0.0751
73933273|NCT00153101|147396421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.3682||95.0|0.63|1.18|||Regression, Cox|||||1.18|0.63|0.3682
73933274|NCT00153101|147396421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6014||95.0|0.69|1.24|||Regression, Cox|||||1.24|0.69|0.6014
73933275|NCT00153101|147396422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.255||95.0|0.91|1.42|||Regression, Cox|||||1.42|0.91|0.2550
74088803|NCT03660241|147730624|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|133.87|||||TWO_SIDED|90.0|102.45|174.92|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||174.92|102.45|
73865343|NCT01597635|147276854|SUPERIORITY||Ratio of Active/Placebo|3.98||||1|TWO_SIDED|95.0|2.263|6.919|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||6.919|2.263|1.0000
73933276|NCT00153101|147396422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.5297||95.0|0.86|1.34|||Regression, Cox|||||1.34|0.86|0.5297
73933277|NCT00153101|147396423|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.4593||95.0|0.82|1.56|||Regression, Cox|||||1.56|0.82|0.4593
73933278|NCT00153101|147396423|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.7468||95.0|0.68|1.32|||Regression, Cox|||||1.32|0.68|0.7468
73933279|NCT00153101|147396424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.5461|TWO_SIDED|95.0|0.71|1.2|||Regression, Cox|||||1.20|0.71|0.5461
73933280|NCT00153101|147396424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.3436||95.0|0.68|1.14|||Regression, Cox|||||1.14|0.68|0.3436
73933281|NCT00153101|147396425|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0133||95.0|0.8|0.97|||Regression, Cox|||||0.97|0.80|0.0133
73933282|NCT00153101|147396425|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.1251||95.0|0.84|1.02|||Regression, Cox|||||1.02|0.84|0.1251
73933283|NCT00153101|147396426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0213||95.0|0.67|0.97|||Regression, Cox|||||0.97|0.67|0.0213
73933284|NCT00153101|147396426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.2396||95.0|0.75|1.07|||Regression, Cox|||||1.07|0.75|0.2396
73933285|NCT00153101|147396427|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0111||95.0|0.83|0.98|||Regression, Cox|||||0.98|0.83|0.0111
73933286|NCT00153101|147396427|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.0606||95.0|0.85|1.0|||Regression, Cox|||||1.00|0.85|0.0606
73933287|NCT00153101|147396428|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.0082||95.0|1.05|1.35|||Regression, Cox|||||1.35|1.05|0.0082
73933288|NCT00153101|147396428|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2164||95.0|0.95|1.23|||Regression, Cox|||||1.23|0.95|0.2164
73933289|NCT00153101|147396429|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.3732||95.0|0.83|1.07|||Regression, Cox|||||1.07|0.83|0.3732
73933290|NCT00153101|147396429|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.3633||95.0|0.94|1.2|||Regression, Cox|||||1.20|0.94|0.3633
73865344|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.46||||1|TWO_SIDED|95.0|1.976|6.052|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||6.052|1.976|1.000
73865345|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.59||||1|TWO_SIDED|95.0|2.06|6.345|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||6.345|2.060|1.0000
73865346|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.82||||0.9806|TWO_SIDED|95.0|1.031|3.17|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||3.170|1.031|0.9806
73971919|NCT05485779|147484130|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.805|||||TWO_SIDED|90.0|0.635|1.02|||||Within-subject geometric coefficient of variation was 20.5. Data analyzed using a mixed model included treatment as a fixed effect and subject as a random effect. ln(parameter)=treatment+subject+random error, with subject fitted as a random effect.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess the Effect of Food on Single Oral Doses of 16 mg AQ280||1.02|0.635|
73971920|NCT05485779|147484132|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.15||||0.1558|TWO_SIDED|95.0|0.954|1.34|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 28.0. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 QD for 7 Consecutive Days in a Fasted State||1.34|0.954|0.1558
73971921|NCT05485779|147484133|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.1||||0.5458|TWO_SIDED|95.0|0.946|1.26|||Lack of Fit 2-sided model|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 24.0. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 QD for 7 Consecutive Days in a Fasted State||1.26|0.946|0.5458
73971922|NCT05485779|147484134|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.941||||0.4856|TWO_SIDED|95.0|0.602|1.28||Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Lack of fit 2-sided||Between-subject geometric coefficient of variation was 54.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 once daily for 7 Consecutive Days in a Fasted State||1.28|0.602|0.4856
73971923|NCT05485779|147484135|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.971||||0.1455|TWO_SIDED|95.0|0.666|1.28|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 45.5. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 once daily for 7 Consecutive Days in a Fasted State||1.28|0.666|0.1455
73971924|NCT02010242|147484136|SUPERIORITY|All statistical analyses were performed on a comparison-wise basis without adjustment for multiple comparisons.||||||1|||||||ANCOVA|||Primary efficacy endpoint was analyzed using ANCOVA comparing GKT137831 vs placebo after controlling for the baseline UACR level. The UACR were log-transformed prior to analysis. The model included treatment group and log-transformed baseline UACR value as predicted variables. The results were back-transformed exponentially to calculate geo. mean values and associated 90% CIs and 1-sided p-values. The null hypothesis was that the difference in the adjusted mean logarithm of UACR was equal to 0||||1.000
73971925|NCT05764525|147484144|SUPERIORITY||Difference of least squares mean|6.938||||0.0047|TWO_SIDED|95.0|2.145|11.731|||ANOVA|||||11.731|2.145|0.0047
73971926|NCT03334630|147484147|NON_INFERIORITY|Assuming a Control composite SAE freedom rate of 93.5%, 226 subjects per group yields 80% power to detect a non-inferiority margin of -6.5% between treatment groups at a significance level of 0.025.|Risk Difference (RD)|0.0324|||<|0.0001|TWO_SIDED|95.0|-0.0132|0.0779||The a priori threshold for statistical significance is 0.025.|Farrington-Manning non-inferiority test||Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.24% = 0.0324|Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.||0.0779|-0.0132|<0.0001
73865347|NCT01597635|147276854|SUPERIORITY||Ratio of Active/Placebo|1.5||||0.9129|TWO_SIDED|95.0|0.828|2.636|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||2.636|0.828|0.9129
73865348|NCT01597635|147276854|SUPERIORITY||Ratio of Active/Placebo|1.92||||0.9891|TWO_SIDED|95.0|1.098|3.349|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||3.349|1.098|0.9891
73865349|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.29||||0.9983|TWO_SIDED|95.0|1.316|3.974|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||3.974|1.316|0.9983
73865350|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.94||||0.99|TWO_SIDED|95.0|1.112|3.359|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||3.359|1.112|0.9900
73865351|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.27||||0.7996|TWO_SIDED|95.0|0.729|2.163|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||2.163|0.729|0.7996
73865352|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.7778|TWO_SIDED|95.0|0.718|2.087|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||2.087|0.718|0.7778
73865353|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.24||||0.773|TWO_SIDED|95.0|0.705|2.113|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||2.113|0.705|0.7730
73933291|NCT00153101|147396430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.2713||95.0|0.97|1.13|||Regression, Cox|||||1.13|0.97|0.2713
73933292|NCT00153101|147396430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.515||95.0|0.95|1.11|||Regression, Cox|||||1.11|0.95|0.5150
73933293|NCT00153101|147396431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.3485||95.0|0.77|1.1|||Regression, Cox|||for subjects without diabetes at baseline||1.10|0.77|0.3485
73933294|NCT00153101|147396431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.1235||95.0|0.96|1.36|||Regression, Cox|||for subjects without diabetes at baseline||1.36|0.96|0.1235
73933295|NCT00153101|147396432|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99||||0.869||95.0|0.89|1.11|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline||1.11|0.89|0.8690
73933296|NCT00153101|147396432|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04||||0.4337||95.0|0.94|1.17|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline||1.17|0.94|0.4337
73933297|NCT00153101|147396433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.2666||95.0|0.83|1.05|||Regression, Cox|||for subjects without atrial fibrillation at baseline||1.05|0.83|0.2666
73933298|NCT00153101|147396433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.4784||95.0|0.85|1.08|||Regression, Cox|||for subjects without atrial fibrillation at baseline||1.08|0.85|0.4784
73933299|NCT00153101|147396434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0483||95.0|0.76|1.0|||Regression, Cox|||||1.00|0.76|0.0483
73933300|NCT00153101|147396435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2192||95.0|0.81|1.05|||Regression, Cox|||||1.05|0.81|0.2192
73933301|NCT00153101|147396436|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7764||95.0|0.85|1.24|||Regression, Cox|||||1.24|0.85|0.7764
73971927|NCT03334630|147484148|NON_INFERIORITY|Assuming a Control primary effectiveness rate of 65%, 229 subjects per group yields 80% power to detect a non-inferiority margin of -12.5% between treatment groups at a significance level of 0.025.|Risk Difference (RD)|0.034|||<|0.0001|TWO_SIDED|95.0|-0.042|0.109||The a priori threshold for statistical significance is 0.025.|Farrington-Manning non-inferiority test||Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.4% = 0.034|Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.||0.109|-0.042|<0.0001
74008295|NCT03627767|147566493|SUPERIORITY||Difference in percentage|30.5|||<|0.0001|TWO_SIDED|95.0|23.9|37.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.2|23.9|< 0.0001
73933302|NCT00153101|147396437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0574||95.0|0.62|1.01|||Regression, Cox|||||1.01|0.62|0.0574
73933303|NCT00153101|147396438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1365||95.0|0.64|1.06|||Regression, Cox|||||1.06|0.64|0.1365
73933304|NCT00153101|147396439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.694||95.0|0.82|1.34|||Regression, Cox|||||1.34|0.82|0.6940
73933305|NCT00153101|147396440|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58||||0.0245||95.0|1.06|2.35|||Regression, Cox|||||2.35|1.06|0.0245
73933306|NCT00153101|147396441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5798||95.0|0.36|1.76|||Regression, Cox|||||1.76|0.36|0.5798
73933307|NCT00153101|147396442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0006||95.0|0.65|0.89|||Regression, Cox|||||0.89|0.65|0.0006
73933308|NCT00153101|147396443|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.0085||95.0|0.48|0.9|||Regression, Cox|||||0.90|0.48|0.0085
73933309|NCT00153101|147396444|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.0015||95.0|0.69|0.92|||Regression, Cox|||||0.92|0.69|0.0015
73933310|NCT00153101|147396445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.0101||95.0|1.08|1.79|||Regression, Cox|||||1.79|1.08|0.0101
73933311|NCT00153101|147396446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9563||95.0|0.82|1.24|||Regression, Cox|||||1.24|0.82|0.9563
73933312|NCT00153101|147396447|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.0868||95.0|0.98|1.41|||Chi-squared|||||1.41|0.98|0.0868
73933313|NCT00153101|147396448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0172||95.0|0.6|0.95|||Regression, Cox|||||0.95|0.60|0.0172
73933314|NCT00153101|147396449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1431||95.0|0.78|1.04|||Regression, Cox|||||1.04|0.78|0.1431
73933315|NCT00153101|147396450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8974||95.0|0.81|1.21|||Regression, Cox|||||1.21|0.81|0.8974
73933316|NCT02610140|147396451|SUPERIORITY||Hazard Ratio (HR)|1.215||||0.859125|TWO_SIDED|95.0|0.85|||1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). P-value is calculated based on alpha level 0.0125.|Log Rank||Hazard ratio (anetumab ravtansine / vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by Time to progression (TTP) on 1st line treatment.|PFS anetumab ravtansine / vinorelbine||1,738|0.850|0.859125
73933317|NCT02610140|147396452|SUPERIORITY||Hazard Ratio (HR)|1.072||||0.655624|TWO_SIDED|95.0|0.763|1.506||1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). Alpha spending/boundary for interim was 0.00245. Alpha boundary value for final analysis was 0.02421.|Log Rank||Hazard ratio (anetumab ravtansine/vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by TTP on 1st line treatment.|OS anetumab ravtansine / vinorelbine||1.506|0.763|0.655624
73933318|NCT02610140|147396457|SUPERIORITY||Difference (%) improvement rate symptoms|4.65||||0.244|TWO_SIDED|95.0|-8.2|17.51|||Cochran-Mantel-Haenszel|1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment||Anetumab ravtansine versus vinorelbine||17.51|-8.20|0.244
73933319|NCT02610140|147396458|SUPERIORITY||Hazard Ratio (HR)|0.829||||0.313747|TWO_SIDED|95.0|0.386|1.779|||Log Rank|one-sided log-rank test stratified by time to progression (TTP) on first line treatment||Anetumab ravtansine versus vinorelbine||1.779|0.386|0.313747
73933320|NCT02610140|147396459|SUPERIORITY||Hazard Ratio (HR)|0.924||||0.378916|TWO_SIDED|95.0|0.557|1.533|||Log Rank|one-sided log-rank test stratified by time to progression (TTP) on first line treatment||Anetumab ravtansine versus vinorelbine||1.533|0.557|0.378916
74088804|NCT03660241|147730624|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|129.49|||||TWO_SIDED|90.0|92.86|180.57|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||180.57|92.86|
73933321|NCT02610140|147396460|SUPERIORITY||Difference (%) improvement rate of pain|6.64||||0.214|TWO_SIDED|95.0|-9.4|22.68|||Cochran-Mantel-Haenszel|1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment||||22.68|-9.40|0.214
73933322|NCT02610140|147396463|SUPERIORITY||Mean Difference (Final Values)|9.5|||||TWO_SIDED|95.0|0.1|39.3||||||||39.3|0.1|
73933323|NCT02610140|147396463|SUPERIORITY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|0.0|35.9||||||||35.9|0.0|
73933324|NCT03169153|147396464|SUPERIORITY||||||<|0.0001|||||||Mixed effects repeated measures|||||||<0.0001
73933325|NCT00887341|147396465|SUPERIORITY_OR_OTHER|||||||0.238|||||||Chi-squared|||||||0.238
73933326|NCT00887341|147396472|SUPERIORITY_OR_OTHER|||||||0.121|||||||Chi-squared|||Week 4||||0.121
73933327|NCT00887341|147396472|SUPERIORITY_OR_OTHER|||||||0.809|||||||Chi-squared|||Week 8||||0.809
73933328|NCT00887341|147396472|SUPERIORITY_OR_OTHER|||||||0.367|||||||Chi-squared|||Week 12||||0.367
73933329|NCT00887341|147396472|SUPERIORITY_OR_OTHER|||||||0.339|||||||Chi-squared|||Week 16||||0.339
73933330|NCT00887341|147396472|SUPERIORITY_OR_OTHER|||||||0.017|||||||Chi-squared|||Week 20||||0.017
73933331|NCT00887341|147396472|SUPERIORITY_OR_OTHER|||||||0.451|||||||Chi-squared|||Final visit||||0.451
73933332|NCT00887341|147396473|SUPERIORITY_OR_OTHER|||||||0.377|||||||Chi-squared|||Week 4||||0.377
73933333|NCT00887341|147396473|SUPERIORITY_OR_OTHER|||||||0.387|||||||Chi-squared|||Week 8||||0.387
73933334|NCT00887341|147396473|SUPERIORITY_OR_OTHER|||||||0.304|||||||Chi-squared|||Week 12||||0.304
73933335|NCT00887341|147396473|SUPERIORITY_OR_OTHER|||||||0.509|||||||Chi-squared|||Week 16||||0.509
73933336|NCT00887341|147396473|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||Week 20||||0.110
73933337|NCT00887341|147396473|SUPERIORITY_OR_OTHER|||||||0.504|||||||Chi-squared|||Final visit||||0.504
73933338|NCT00887341|147396474|SUPERIORITY_OR_OTHER|||||||0.327|||||||Chi-squared|||Week 4||||0.327
73933339|NCT00887341|147396474|SUPERIORITY_OR_OTHER|||||||0.786|||||||Chi-squared|||Week 8||||0.786
73933340|NCT00887341|147396474|SUPERIORITY_OR_OTHER|||||||0.482|||||||Chi-squared|||Week 12||||0.482
73933341|NCT00887341|147396474|SUPERIORITY_OR_OTHER|||||||0.68|||||||Chi-squared|||Week 16||||0.680
73933342|NCT00887341|147396474|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||Week 20||||0.690
73971928|NCT03334630|147484149|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-21.2|-14.6||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||-14.6|-21.2|<0.0001
73933343|NCT00887341|147396474|SUPERIORITY_OR_OTHER|||||||0.516|||||||Chi-squared|||Final Visit||||0.516
73933344|NCT00887341|147396475|SUPERIORITY_OR_OTHER|||||||0.97|||||||Chi-squared|||Week 8||||0.970
73933345|NCT00887341|147396475|SUPERIORITY_OR_OTHER|||||||0.587|||||||Chi-squared|||Week 12||||0.587
73933346|NCT00887341|147396475|SUPERIORITY_OR_OTHER|||||||0.184|||||||Chi-squared|||Week 16||||0.184
73933347|NCT00887341|147396475|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||Week 20||||0.600
73933348|NCT00887341|147396475|SUPERIORITY_OR_OTHER|||||||0.937|||||||Chi-squared|||Final Visit||||0.937
73933349|NCT01591681|147396484|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||Sample size was computed to be 45 participants using the system for 42 nights (21 nights with system active and 21 control nights) for a total of 1,890 nights in order to have 90% power with a type 1 error rate of 5% to reject the null hypothesis of no difference in nocturnal hypoglycemia assuming a true population rate of 30% of control nights and 15% of intervention nights with hypoglycemia after adjusting for the correlation from repeated nights and misclassification due to sensor inaccuracy.||||<0.001
73933350|NCT01591681|147396485|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||<0.001
73933351|NCT01591681|147396486|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
73933352|NCT01591681|147396487|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
73933353|NCT01591681|147396488|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
73933354|NCT01591681|147396489|SUPERIORITY_OR_OTHER|||||||0.71||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.71
73933355|NCT01591681|147396490|SUPERIORITY_OR_OTHER|||||||0.62||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.62
73933356|NCT01591681|147396491|SUPERIORITY_OR_OTHER|||||||0.1||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.10
73933357|NCT01591681|147396492|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
73933358|NCT01591681|147396493|SUPERIORITY_OR_OTHER|||||||0.98||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||0.98
73933359|NCT01591681|147396494|SUPERIORITY_OR_OTHER|||||||0.93||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||0.93
73933360|NCT01312961|147396511|SUPERIORITY||Odds Ratio (OR)|0.077|||<|0.0001|TWO_SIDED|95.0|0.021|0.28||Threshold for significance at 0.05 level.|Regression, Logistic||Dupilumab 300 mg vs. Placebo|Analysis was performed using a logistic regression model with treatment groups and stratification factor (prior ICS/LABA combination therapy dose) as covariates.||0.280|0.021|<0.0001
73933361|NCT04278417|147396530|NON_INFERIORITY|Non-inferiority of brolucizumab to PRP with respect to change from baseline in BCVA at Week 54, considering a non-inferiority margin of 4 ETDRS letters. Assuming that the BCVA changes follow a normal distribution with equal means between treatments, and a common standard deviation of 10 letters, for a one-sided alpha level of 0.025, with 300 subjects per arm there is \>99% power to reject the null hypothesis that brolucizumab 6 mg is inferior to PRP.|LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|1.03|<|0.001|TWO_SIDED|95.0|2.4|6.4|||ANCOVA|||1||6.4|2.4|<0.001
73933362|NCT04278417|147396530|SUPERIORITY||||||<|0.001|||||||ANCOVA|||2||||<0.001
73933363|NCT04278417|147396531|SUPERIORITY||Difference in % of Participants|39.4|||<|0.001|TWO_SIDED|95.0|32.0|46.8|||Cochran-Mantel-Haenszel|||||46.8|32.0|< 0.001
73933364|NCT04278417|147396533|SUPERIORITY||Difference in % of Participants|-41.1|||<|0.001|TWO_SIDED|95.0|-48.0|-34.2|||Cochran-Mantel-Haenszel|||||-34.2|-48.0|< 0.001
73933365|NCT04278417|147396536|SUPERIORITY||Difference in % of Participants|26.4|||<|0.001|TWO_SIDED|95.0|19.5|33.3|||Cochran-Mantel-Haenszel|||Week 54||33.3|19.5|<0.001
73933366|NCT01331694|147396549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||||95.0|1.5|1.79|||||Hazard ratio for hospitalization or emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.79|1.50|
73933367|NCT01331694|147396549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||||95.0|1.17|1.41|||||Hazard ratio for hospitalization or emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.41|1.17|
73933368|NCT01331694|147396549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.78||||||95.0|1.59|2.0|||||Hazard ratio for emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||2.00|1.59|
73933369|NCT01331694|147396549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.51|1.17|
73933370|NCT01331694|147396549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||||95.0|1.41|1.94|||||Hazard ratio for outpatient visit with oral steroid fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.94|1.41|
73933371|NCT01331694|147396549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||||95.0|1.26|1.76|||||Hazard ratio for outpatient visit with oral steroid fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.76|1.26|
73933372|NCT01331694|147396549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||||95.0|1.23|1.57|||||Hazard ratio for outpatient visit with antibiotic fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.57|1.23|
74030414|NCT02078713|147615158|SUPERIORITY||Odds Ratio (OR)|1.45||||0.03|TWO_SIDED|95.0|1.03|2.05||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of uncertainty subscale of DCS||2.05|1.03|0.03
73933373|NCT01331694|147396549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for outpatient visit with antibiotic fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.51|1.17|
73933374|NCT01652716|147396552|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1349||0.0072|TWO_SIDED|95.0|-0.63|-0.1|||Mixed model for repeated measure (MMRM)|Based on a repeated measures mixed model including fixed categorical effects of treatment||||-0.10|-0.63|0.0072
73933375|NCT01652716|147396553|SUPERIORITY_OR_OTHER|||||||0.2247|||||||Cochran-Mantel-Haenszel|||||||0.2247
73933376|NCT01652716|147396554|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|5.841||0.1656|TWO_SIDED|95.0|-21.7|1.3||Adjusted|Cochran-Mantel-Haenszel|||||1.3|-21.7|0.1656
73933377|NCT01652716|147396555|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.4497||0.3744|TWO_SIDED|95.0|-0.48|1.28|||Cochran-Mantel-Haenszel|||||1.28|-0.48|0.3744
73933378|NCT01652716|147396556|SUPERIORITY_OR_OTHER||LS Mean Difference|26.74|STANDARD_ERROR_OF_MEAN|15.8957||0.0985|TWO_SIDED|95.0|-5.16|58.64|||Cochran-Mantel-Haenszel|||||58.64|-5.16|0.0985
73933379|NCT00594256|147396572|SUPERIORITY_OR_OTHER||||||=|0.002||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||=0.002
73933380|NCT00594256|147396573|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.02
73933381|NCT00594256|147396574|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.04
73933382|NCT00594256|147396575|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.8
73933383|NCT00594256|147396576|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 1 sided|||Open label baseline final paired t test||||<0.01
73933384|NCT04160260|147396577|EQUIVALENCE|Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.|Geometric Mean Ratio|95.17|||||TWO_SIDED|90.0|84.2|107.5|||||A t-test on the natural log-transformed PK parameter AUC(0-48) was performed to obtain the Geometric Mean Ratio and its confidence interval.|Comparison was performed with the 100 mg intravenous (IV) omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log Geometric Mean (GM) AUC(0-48) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.98 (0.2091).||107.5|84.2|
73933385|NCT04160260|147396578|EQUIVALENCE|Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.|Geometric Mean Ratio|100.8|||||TWO_SIDED|90.0|88.0|115.5|||||A t-test on the natural log-transformed PK parameter AUC(0-24) was performed to obtain the Geometric Mean Ratio and its confidence interval.|Comparison was performed with the 100 mg IV omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log GM AUC(0-24) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.26 (0.1985).||115.5|88.0|
73933386|NCT01208233|147396632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.735||||0.4962|TWO_SIDED|80.0|0.41|1.31|||Regression, Logistic|LOCF was used to impute missing data.||||1.31|0.41|0.4962
73933387|NCT01208233|147396632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.561||||0.2517|TWO_SIDED|80.0|0.29|1.07|||Regression, Logistic|The analysis was based on OC.||||1.07|0.29|0.2517
73933388|NCT01208233|147396633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|3.942||0.9716|TWO_SIDED|80.0|-4.972|5.254|||Mixed Models Analysis|||Paretic hand||5.254|-4.972|0.9716
73933389|NCT01208233|147396634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.789|STANDARD_ERROR_OF_MEAN|7.2392||0.1417|TWO_SIDED|80.0|1.401|20.177|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)||20.177|1.401|0.1417
73933390|NCT01208233|147396635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.33|STANDARD_ERROR_OF_MEAN|5.4241||0.0611|TWO_SIDED|80.0|-17.351|-3.31|||Mixed Models Analysis|||Paretic hand||-3.310|-17.351|0.0611
73933391|NCT01208233|147396635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|3.2899||0.9433|TWO_SIDED|80.0|-4.011|4.48|||Mixed Models Analysis|||Non-paretic hand||4.480|-4.011|0.9433
73933392|NCT01208233|147396636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.812|STANDARD_ERROR_OF_MEAN|6.8448||0.0654|TWO_SIDED|80.0|-21.668|-3.957|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)||-3.957|-21.668|0.0654
73933393|NCT01208233|147396637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.972||||0.951|TWO_SIDED|80.0|0.54|1.76|||Regression, Logistic|||LOCF was used to impute missing data.||1.76|0.54|0.9510
73933394|NCT01208233|147396638|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.854||||0.7234|TWO_SIDED|80.0|0.48|1.51|||Regression, Logistic|||LOCF was used to impute missing data.||1.51|0.48|0.7234
73933395|NCT01208233|147396639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.283|STANDARD_ERROR_OF_MEAN|0.6755||0.6759|TWO_SIDED|80.0|-1.156|0.589|||Mixed Models Analysis|||||0.589|-1.156|0.6759
73933396|NCT01208233|147396640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.433||||0.4213|TWO_SIDED|80.0|0.81|2.54|||Regression, Logistic|||BI \>=95, LOCF was used to impute missing data.||2.54|0.81|0.4213
73933397|NCT01208233|147396640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.651||||0.276|TWO_SIDED|80.0|0.92|2.98|||Regression, Logistic|||BI=100, LOCF was used to impute missing data.||2.98|0.92|0.2760
73933398|NCT01208233|147396641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.599|STANDARD_ERROR_OF_MEAN|4.4547||0.2118|TWO_SIDED|80.0|-0.15|11.348|||Mixed Models Analysis|||||11.348|-0.150|0.2118
74008296|NCT03627767|147566493|SUPERIORITY||Difference in percentage|48.9|||<|0.0001|TWO_SIDED|95.0|42.1|55.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||55.6|42.1|< 0.0001
73933399|NCT01208233|147396642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.062|STANDARD_ERROR_OF_MEAN|1.7844||0.5541|TWO_SIDED|80.0|-1.252|3.375|||Mixed Models Analysis|||||3.375|-1.252|0.5541
73933400|NCT01208233|147396643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.334|STANDARD_ERROR_OF_MEAN|0.4178||0.426|TWO_SIDED|80.0|-0.874|0.205|||Mixed Models Analysis|||||0.205|-0.874|0.4260
73933401|NCT01208233|147396644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.477|STANDARD_ERROR_OF_MEAN|5.4394||0.65|TWO_SIDED|80.0|-4.547|9.5|||Mixed Models Analysis|||(L+R)/28 × 100%||9.500|-4.547|0.6500
73933402|NCT01208233|147396644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.874|STANDARD_ERROR_OF_MEAN|6.7431||0.5671|TWO_SIDED|80.0|-4.834|12.583|||Mixed Models Analysis|||(L/14) × 100%||12.583|-4.834|0.5671
73933403|NCT01208233|147396644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.049|STANDARD_ERROR_OF_MEAN|5.2816||0.843|TWO_SIDED|80.0|-5.771|7.87|||Mixed Models Analysis|||(R/14) × 100%||7.870|-5.771|0.8430
73933404|NCT01208233|147396645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.0733||0.1512|TWO_SIDED|80.0|0.011|0.201|||Mixed Models Analysis|||(L R)/(L+R)||0.201|0.011|0.1512
73933405|NCT01208233|147396646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.279|STANDARD_ERROR_OF_MEAN|0.5041||0.0128|TWO_SIDED|80.0|-1.929|-0.629|||Mixed Models Analysis|||||-0.629|-1.929|0.0128
73933406|NCT01208233|147396647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.1226||0.4713|TWO_SIDED|80.0|-0.07|0.248|||Mixed Models Analysis|||||0.248|-0.070|0.4713
73933407|NCT01208233|147396654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.516|STANDARD_ERROR_OF_MEAN|2.7201||0.8501|TWO_SIDED|80.0|-4.026|2.995|||Mixed Models Analysis|||Non-paretic hand||2.995|-4.026|0.8501
73933408|NCT01891734|147396656|SUPERIORITY_OR_OTHER||Cohen's d|0.3|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
73933409|NCT01891734|147396657|SUPERIORITY_OR_OTHER||Cohen's d|0.3|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
73971929|NCT03334630|147484150|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-11.9|||<|0.0001|TWO_SIDED|95.0|-13.9|-9.8||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||-9.8|-13.9|<0.0001
73971930|NCT03334630|147484159|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-5.7|||||TWO_SIDED|95.0|-14.4|3.1||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.||Since the previous secondary endpoint (Total fluoroscopy time) was non-significant, testing stopped and this secondary endpoint was not tested.|Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||3.1|-14.4|
73971931|NCT03334630|147484164|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-0.2||||0.8528|TWO_SIDED|95.0|-1.9|1.6||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||1.6|-1.9|0.8528
73971932|NCT03910478|147484250|EQUIVALENCE|A two-sided Wald-test for evidence of a non-zero coefficient for intervention group in the regression was conducted at the 5% significance level.|Odds Ratio (OR)|0.948||||0.892|TWO_SIDED|95.0|0.438|2.053|||Regression, Logistic|The logistic regression was adjusted by covariates (transplant site and participant's perceived ease of access to blood draw facility).||A traditional logistic regression model was fit where the outcome was whether or not participants completed \> 90% of their clinician-recommended CMV monitoring tests in the study period by 1-year after HCT.||2.053|0.438|0.8920
73971933|NCT03910478|147484251|EQUIVALENCE|A two-sided Wald-test for evidence of a non-zero coefficient for intervention group in the regression was conducted at the 5% significance level.|Odds Ratio (OR)|0.66||||0.3008|TWO_SIDED|95.0|0.301|1.45|||Regression, Logistic|The logistic regression was adjusted by covariates (transplant site and participant's perceived ease of access to blood draw facility).||A traditional logistic regression model was fit where the outcome was whether or not participants completed \> 90% of their clinician -recommended CMV monitoring tests in the study period by 1-year after HCT.||1.450|0.301|0.3008
73971934|NCT06415292|147484281|SUPERIORITY||||||<|0.001||||||The P-value reported here is the calculated p-value. The p-value theshold for significance was p =0.05|t-test, 2 sided|||||||<0.001
73971935|NCT01712490|147484283|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.035|TWO_SIDED|95.0|0.603|0.983|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% confidence interval (CI) are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of International Prognostic Factor Project (IPFP) risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio less than (\<) 1 favors A+AVD arm.||0.983|0.603|0.035
73971936|NCT01712490|147484284|SUPERIORITY||Hazard Ratio (HR)|0.728||||0.199|TWO_SIDED|95.0|0.448|1.184|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% CI are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of IPFP risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio \<1 favors A+AVD arm.||1.184|0.448|0.199
73971937|NCT03987022|147484308|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||.16
73971938|NCT03987022|147484309|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
73971939|NCT03987022|147484310|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||.01
73971940|NCT03987022|147484311|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
73971941|NCT03987022|147484312|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||.58
73971942|NCT03987022|147484313|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||.47
73971943|NCT03987022|147484314|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
73971944|NCT03987022|147484315|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||.02
73971945|NCT03987022|147484316|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73971946|NCT02432261|147484318|SUPERIORITY|We did not statistically power this study.|difference of proportion of subjects|57.6||||0.003|TWO_SIDED||||||Fisher Exact||The difference of proportion = NES/Testosterone - Testosterone|||||0.003
73971947|NCT02724969|147484400|SUPERIORITY|||||||0.272|||||||Mixed Models Analysis|||||||.272
74088805|NCT03660241|147730625|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|210.2|||||TWO_SIDED|90.0|154.6|285.8|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||285.80|154.60|
74088806|NCT03660241|147730625|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|290.68|||||TWO_SIDED|90.0|217.39|388.69|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||388.69|217.39|
73933410|NCT01181895|147396658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.244|TWO_SIDED|95.0|-0.048|0.188||P-value for the adjusted treatment difference for Vilanterol 25 µg OD versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Vilanterol 25 µg OD versus Placebo.|||0.188|-0.048|0.244
73933411|NCT01181895|147396658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.926|TWO_SIDED|95.0|-0.124|0.113||P-value for the adjusted treatment difference for Salmetarol 50 µg BID versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Salmeterol 50 µg BID versus Placebo.|||0.113|-0.124|0.926
73933412|NCT01114516|147396676|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Log Rank|||Kaplan Meier survival analysis||||0.018
73933413|NCT01114516|147396677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|1.06|2.05||||||||2.05|1.06|
73933414|NCT01114516|147396678|SUPERIORITY_OR_OTHER|||||||0.393|TWO_SIDED||||||Kruskal-Wallis|||||||0.393
73933415|NCT03223298|147396761|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||3-month mean change (from pre-op) in Jaw Pain compared between the Botox group and Placebo group.||||0.80
73933416|NCT03223298|147396762|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||3-month mean Jaw Function Limitation Scale score compared between Botox group and placebo group.||||0.50
73933417|NCT03223298|147396763|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Change in MIO with Pain at 3-months post-intervention compared between Botox group and Placebo group.||||0.30
73933418|NCT03223298|147396763|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Change in MIO without Pain at 3-months post-intervention compared between Botox group and Placebo group.||||0.50
73933419|NCT03223298|147396764|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Mean change at 3 months post intervention - General Health Score, compared between Botox group and Placebo group.||||0.40
73933420|NCT01040871|147396769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.038||||0.915|TWO_SIDED|95.0|0.529|2.037|||Cochran-Mantel-Haenszel|Stratified by IPI score|Odds ratio: VR-CAP CR rate relative to R-CHOP CR rate|||2.037|0.529|0.915
73933421|NCT00673049|147396799|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.35|TWO_SIDED|95.0|0.909|1.31||One-sided significance level at alpha=0.024 was used. Two-sided p-value was reported.|Log Rank|Nominal p-values were reported without adjustment for the interim analysis.||P-value was calculated using log-rank test stratified by gender (Male or Female), Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to \[=\<1\] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.||1.310|0.909|0.35
73933422|NCT00673049|147396800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.426|TWO_SIDED|95.0|0.898|1.287||One-sided significance level at alpha=0.001 was used. Two-sided p-value was reported.|Log Rank|||P-value was calculated using log-rank test stratified by gender (Male or Female), ECOG performance status (less than or equal to \[=\<1\] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.||1.287|0.898|0.426
73933423|NCT00673049|147396801|SUPERIORITY_OR_OTHER||Difference in response rates|1.668||||0.338|TWO_SIDED|95.0|-1.7|5.1|||Chi-squared|||||5.1|-1.7|0.338
73933424|NCT00924950|147396809|SUPERIORITY||Mean Difference (Final Values)|0.8571||||0.0008|TWO_SIDED||||||t-test, 2 sided|||||||0.0008
73971948|NCT02724969|147484401|SUPERIORITY|||||||0.082|||||||Mixed Models Analysis|||||||.082
73971949|NCT02724969|147484402|SUPERIORITY|||||||0.355|||||||Mixed Models Analysis|||||||.355
73971950|NCT02724969|147484403|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||||||.780
73933425|NCT04193202|147396811|SUPERIORITY||Estimated difference|0.75||||0.034|TWO_SIDED|95.0|0.06|1.44|||Longitudinal ANCOVA|The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline LCQ total score.|The estimated difference is the treatment difference in model based mean change from baseline at Week 12|||1.44|0.06|0.034
73933426|NCT04193202|147396812|OTHER||Estimated Difference|-6.92||||0.006|TWO_SIDED|95.0|-11.88|-1.97||Nominal p value, not controlled for multiplicity|Longitudinal ANCOVA|The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline mean weekly cough severity VAS score.|The estimated difference is the treatment difference in model based mean change from baseline at Week 12.|||-1.97|-11.88|0.006
73933427|NCT02979535|147396815|OTHER||GMT ratio|0.947|||||TWO_SIDED|95.0|0.773|1.16||||||Antigen HPV-16||1.16|0.773|
73933428|NCT02979535|147396815|OTHER||GMT ratio|0.986|||||TWO_SIDED|95.0|0.803|1.21||||||Antigen HPV-18||1.21|0.803|
73933429|NCT02979535|147396816|OTHER||GMT ratio|0.977|||||TWO_SIDED|95.0|0.653|1.46||||||Dengue Virus Serotype 1||1.46|0.653|
73933430|NCT02979535|147396816|OTHER||GMT ratio|0.911|||||TWO_SIDED|95.0|0.654|1.27||||||Dengue Virus Serotype 2||1.27|0.654|
73933431|NCT02979535|147396816|OTHER||GMT ratio|0.921|||||TWO_SIDED|95.0|0.727|1.17||||||Dengue Virus Serotype 3||1.17|0.727|
73933432|NCT02979535|147396816|OTHER||GMT ratio|0.931|||||TWO_SIDED|95.0|0.733|1.18||||||Dengue Virus Serotype 4||1.18|0.733|
73933433|NCT02057757|147396839|EQUIVALENCE|The equivalence margin is 1.25 Days.||||||0.5634|||||||Fay - Shaw|||||||0.5634
73933434|NCT02057757|147396840|SUPERIORITY|||||||0.645||||||The p-value for each time point was calculated; Day 3|Fay - Shaw|||||||0.645
73933435|NCT02057757|147396840|SUPERIORITY|||||||0.989||||||The p-value for each value was calculated (Day 7).|Fay-Shaw|||||||0.989
73933436|NCT02057757|147396840|SUPERIORITY|||||||0.809||||||Day 14|Fay-Shaw|||||||0.809
73933437|NCT02057757|147396840|SUPERIORITY|||||||0.671||||||Day 28|Fay-Shaw|||||||0.671
73933438|NCT02057757|147396842|SUPERIORITY|||||||0.4277||||||Cough|Fay - Shaw|||||||0.4277
73933439|NCT02057757|147396842|SUPERIORITY|||||||0.4022||||||Sore Throat|Fay-Shaw|||||||0.4022
73933440|NCT02057757|147396842|SUPERIORITY|||||||0.5957||||||Fatigue|Fay-Shaw|||||||0.5957
73933441|NCT02057757|147396842|SUPERIORITY|||||||0.0446||||||Nasal Discharge|Fay-Shaw|||||||0.0446
73971951|NCT02724969|147484404|SUPERIORITY|||||||0.588|||||||Mixed Models Analysis|||||||.588
73971952|NCT03125070|147484428|SUPERIORITY|||||||0.9||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.90
73971953|NCT03125070|147484429|SUPERIORITY|||||||0.6||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.60
73971954|NCT03125070|147484430|OTHER|||||||0.27||||||The threshold for statistical significance was p=0.05|Chi-squared|||Sex: Female vs. Male||||0.27
73865354|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.45||||0.8951|TWO_SIDED|95.0|0.814|2.604|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.604|0.814|0.8951
73865355|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.57||||0.9324|TWO_SIDED|95.0|0.276|1.183|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||1.183|0.276|0.9324
73933442|NCT02057757|147396842|SUPERIORITY|||||||0.8628||||||Difficulty Breathing|Fay-Shaw|||||||0.8628
73933443|NCT02057757|147396842|SUPERIORITY|||||||0.16||||||Headache|Fay-Shaw|||||||0.16
73933444|NCT02057757|147396842|SUPERIORITY|||||||0.1234||||||Muscle Pain|Fay-Shaw|||||||0.1234
73933445|NCT02057757|147396842|SUPERIORITY|||||||0.2155||||||Nausea|Fay-Shaw|||||||0.2155
73933446|NCT02057757|147396842|SUPERIORITY|||||||0.5176||||||Vomiting|Fay-Shaw|||||||0.5176
73971955|NCT03125070|147484430|OTHER|||||||0.88||||||The threshold for statistical significance was p=0.05|Chi-squared|||Age \<70 vs. \>=70||||0.88
73971956|NCT03125070|147484430|OTHER|||||||0.98||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Race and ethnicity: white AND non-Hispanic versus any other combination of race and ethnicity (BIPOC)||||0.98
73971957|NCT03125070|147484430|OTHER|||||||0.19||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Education: High school or less versus at least some college or vocational/technical program||||0.19
73865356|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.63||||0.8982|TWO_SIDED|95.0|0.351|1.257|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.257|0.351|0.8982
74030415|NCT02078713|147615158|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5|TWO_SIDED|95.0|0.8|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of effective decision subscale||1.59|0.80|0.5
74088807|NCT01744093|147730630|OTHER|Descriptive proportion|Proportion (percent)|18.8|||||TWO_SIDED|95.0|4.0|45.6|||||Exact two-sided 95% Clopper-Pearson confidence interval.|||45.6|4.0|
73933447|NCT02057757|147396842|SUPERIORITY|||||||0.6986||||||Diarrhea|Fay-Shaw|||||||0.6986
73865357|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|4.22||||0.9998|TWO_SIDED|95.0|1.91|8.905|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||8.905|1.910|0.9998
73865358|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.67||||0.9993|TWO_SIDED|95.0|1.689|7.97|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||7.970|1.689|0.9993
73933448|NCT02057757|147396843|SUPERIORITY|||||||0.985|||||||Fay - Shaw|||||||0.9850
73933449|NCT02057757|147396844|SUPERIORITY|||||||0.681||||||Any Time|Fay - Shaw|||||||0.681
73933450|NCT02057757|147396844|SUPERIORITY|||||||0.341||||||Day 0|Fay-Shaw|||||||0.341
73933451|NCT02057757|147396844|SUPERIORITY|||||||0.321||||||Day 3|Fay-Shaw|||||||0.321
73933452|NCT02057757|147396844|SUPERIORITY|||||||0.957||||||Day 7|Fay-Shaw|||||||0.957
73933453|NCT02057757|147396844|SUPERIORITY|||||||0.788||||||Day 14|Fay-Shaw|||||||0.788
73933454|NCT02057757|147396844|SUPERIORITY|||||||0.544||||||Day 28|Fay-Shaw|||||||0.544
73933455|NCT02057757|147396845|SUPERIORITY|||||||0.671||||||Any Time|Fay - Shaw|||||||0.671
73933456|NCT02057757|147396845|SUPERIORITY|||||||0.325||||||Day 0|Fay-Shaw|||||||0.325
73933457|NCT02057757|147396845|SUPERIORITY|||||||0.987||||||Day 3|Fay-Shaw|||||||0.987
73933458|NCT02057757|147396845|SUPERIORITY|||||||0.987||||||Day 7|Fay-Shaw|||||||0.987
73865359|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|5.26||||1|TWO_SIDED|95.0|2.392|11.754|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||11.754|2.392|1.0000
73865360|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.25||||0.9713|TWO_SIDED|95.0|0.972|5.136|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||5.136|0.972|0.9713
73933459|NCT02057757|147396845|SUPERIORITY|||||||0.311||||||Day 14|Fay-Shaw|||||||0.311
73933460|NCT02057757|147396846|SUPERIORITY|||||||0.973||||||Any Time|Fay - Shaw|||||||0.973
73933461|NCT02057757|147396846|SUPERIORITY|||||||0.575||||||Day 0|Fay-Shaw|||||||0.575
73933462|NCT02057757|147396846|SUPERIORITY|||||||0.548||||||Day 3|Fay-Shaw|||||||0.548
73933463|NCT02057757|147396846|SUPERIORITY|||||||0.987||||||Day 7|Fay-Shaw|||||||0.987
73933464|NCT02057757|147396846|SUPERIORITY|||||||0.987||||||Day 14|Fay-Shaw|||||||0.987
73933465|NCT02057757|147396846|SUPERIORITY|||||||0.987||||||Day 28|Fay-Shaw|||||||0.987
73933466|NCT02057757|147396847|SUPERIORITY|||||||0.928||||||Pneumonia|Fay - Shaw|||||||0.928
73933467|NCT02057757|147396847|SUPERIORITY|||||||0.9669||||||ARDS|Fay-Shaw|||||||0.9669
73933468|NCT02057757|147396847|SUPERIORITY|||||||0.0832||||||Bronchitis|Fay-Shaw|||||||0.0832
73933469|NCT02057757|147396848|SUPERIORITY|||||||0.036||||||Adults (\>= 18 Years ) - Global Assessment: Have you felt as good as you did before you had the respiratory illness?|Fay - Shaw|||||||0.0360
73933470|NCT02057757|147396848|SUPERIORITY|||||||0.038||||||Adults (\>= 18 Years) - Global Assessment: Are you functioning as well as you were before you had the respiratory illness?|Fay-Shaw|||||||0.0380
73933471|NCT02057757|147396848|SUPERIORITY|||||||0.5035||||||Children (\< 18 Years) - Global Assessment: Have you/your child felt as good as you did before you had the respiratory illness?|Fay-Shaw|||||||0.5035
73933472|NCT02057757|147396848|SUPERIORITY|||||||0.9231||||||Children (\<18 Years) - Global Assessment: Are you/your child functioning as well as you/your child were before you/your child had the respiratory illness?|Fay-Shaw|||||||0.9231
73933473|NCT02057757|147396852|SUPERIORITY|||||||0.9785||||||No Detectable Virus on Day 3|Fay-Shaw|||||||0.9785
73933474|NCT00456092|147396889|SUPERIORITY||Odds Ratio (OR)|4.19||||0.002|TWO_SIDED|95.0|1.72|10.2||A p-value \< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected|||||10.20|1.72|0.002
73933475|NCT00456092|147396889|SUPERIORITY||Odds Ratio (OR)|5.77|||<|0.001|TWO_SIDED|95.0|2.4|13.88||A p-value \< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected|||||13.88|2.40|< 0.001
73933476|NCT00456092|147396892|SUPERIORITY||Odds Ratio (OR)|5.12||||0.056|TWO_SIDED|95.0|1.06|24.67|||Chi-squared, Corrected|||||24.67|1.06|0.056
73933477|NCT00456092|147396892|SUPERIORITY||Odds Ratio (OR)|6.95||||0.012|TWO_SIDED|95.0|1.49|32.35|||Chi-squared, Corrected|||||32.35|1.49|0.012
73933478|NCT00456092|147396893|SUPERIORITY||Odds Ratio (OR)|5.4||||0.204|TWO_SIDED|95.0|0.61|47.54|||Chi-squared, Corrected|||||47.54|0.61|0.204
73933479|NCT00456092|147396893|SUPERIORITY||Odds Ratio (OR)|4.12||||0.371|TWO_SIDED|95.0|0.45|37.88|||Chi-squared, Corrected|||||37.88|0.45|0.371
73933480|NCT00456092|147396894|SUPERIORITY||Odds Ratio (OR)|1.568||||0.264|TWO_SIDED|95.0|0.79|3.11|||Chi-squared, Corrected|||||3.11|0.79|0.264
73933481|NCT00456092|147396894|SUPERIORITY||Odds Ratio (OR)|1.98||||0.071|TWO_SIDED|95.0|1.0|3.91|||Chi-squared, Corrected|||||3.91|1.00|0.071
73933482|NCT00456092|147396895|SUPERIORITY||Odds Ratio (OR)|1.305||||0.549|TWO_SIDED|95.0|0.66|2.57|||Chi-squared, Corrected|||||2.57|0.66|0.549
73933483|NCT00456092|147396895|SUPERIORITY||Odds Ratio (OR)|1.033||||1|TWO_SIDED|95.0|0.53|2.03|||Chi-squared, Corrected|||||2.03|0.53|1.000
73933484|NCT00456092|147396896|SUPERIORITY||Odds Ratio (OR)|2.06||||0.083|TWO_SIDED|95.0|0.98|4.34|||Chi-squared, Corrected|||||4.34|0.98|0.083
73933485|NCT00456092|147396896|SUPERIORITY||Odds Ratio (OR)|1.63||||0.279|TWO_SIDED|95.0|0.77|3.44|||Chi-squared, Corrected|||||3.44|0.77|0.279
73933486|NCT00456092|147396897|SUPERIORITY||Odds Ratio (OR)|1.32||||0.548|TWO_SIDED|95.0|0.66|2.66|||Chi-squared, Corrected|||||2.66|0.66|0.548
73933487|NCT00456092|147396897|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.52|2.11|||Chi-squared, Corrected|||||2.11|0.52|1.000
73933488|NCT00456092|147396900|SUPERIORITY||Treatment Difference|11.58||||0.136|TWO_SIDED||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo|||||0.136
73971958|NCT03125070|147484430|OTHER|||||||0.24||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Income: \<$100,000 annual versus \>=$100,000 annual||||0.24
73971959|NCT03125070|147484430|OTHER|||||||0.28||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer the survey items for this measure are shown as unknwon in the table and are excluded from the statistical test.||PHQ score at baseline: no depression (\<10), mild depression (10-14), moderate depression (15-19), severe depression (\>=20)||||0.28
73971960|NCT03125070|147484430|OTHER|||||||0.33||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer the survey items for this measure are shown as unknwon in the table and are excluded from the statistical test.||CTXD score at baseline \<0.9 (not distressed) or \>=0.9 (distressed)||||0.33
73971961|NCT03125070|147484430|OTHER|||||||0.1||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Cardiometabolic Healthcare Utilization (HCU-C) score at baseline: \>.80 versus \<.80||||0.10
73933489|NCT00456092|147396900|SUPERIORITY||Treatment Difference|13.53||||0.08|TWO_SIDED||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo|||||0.080
73933490|NCT00456092|147396901|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.65|TWO_SIDED|95.0|0.745|1.211|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||1.211|0.745|0.650
73933491|NCT00456092|147396901|SUPERIORITY||Hazard Ratio (HR)|1.265||||0.283|TWO_SIDED|95.0|0.791|2.024|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.024|0.791|0.283
73933492|NCT00456092|147396902|SUPERIORITY||Hazard Ratio (HR)|1.337||||0.253|TWO_SIDED|95.0|0.791|2.26|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.260|0.791|0.253
73933493|NCT00456092|147396902|SUPERIORITY||Hazard Ratio (HR)|3.023||||0.026|TWO_SIDED|95.0|1.059|8.63|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||8.630|1.059|0.026
73933494|NCT00456092|147396903|SUPERIORITY||Hazard Ratio (HR)|1.006||||0.984|TWO_SIDED|95.0|0.457|2.215|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.215|0.457|0.984
73933495|NCT00456092|147396903|SUPERIORITY||Hazard Ratio (HR)|0.872||||0.836|TWO_SIDED|95.0|0.158|4.797|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||4.797|0.158|0.836
73933496|NCT00456092|147396908|SUPERIORITY||Adjusted Mean Difference|1.4||||0.308|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component||||0.308
73933497|NCT00456092|147396908|SUPERIORITY||Adjusted Mean Difference|4.1||||0.003|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component||||0.003
73933498|NCT00456092|147396908|SUPERIORITY||Adjusted Mean Difference|1.6||||0.182|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component||||0.182
73933499|NCT00456092|147396908|SUPERIORITY||Adjusted Mean Difference|2.7||||0.026|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component||||0.026
73933500|NCT00456092|147396909|SUPERIORITY||Adjusted Mean Difference|-2.1||||0.016|TWO_SIDED||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.016
73933501|NCT00456092|147396909|SUPERIORITY||Adjusted Mean Difference|-1.4||||0.105|TWO_SIDED||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.105
73865361|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.19||||0.9649|TWO_SIDED|95.0|0.94|4.975|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||4.975|0.940|0.9649
73933502|NCT00456092|147396911|SUPERIORITY||Adjusted Mean Difference|3.3||||0.028|TWO_SIDED||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors and baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.028
73933503|NCT00456092|147396911|SUPERIORITY||Adjusted Mean Difference|4.3||||0.004|TWO_SIDED||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors with baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.004
73933504|NCT01168999|147396931|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<0.01
73933505|NCT01168999|147396932|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared|||||||0.01
73933506|NCT01168999|147396933|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
73933507|NCT01168999|147396934|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
73933508|NCT01168999|147396935|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Repeated Measure ANOVA|||||||0.05
73933509|NCT01168999|147396936|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
73933510|NCT00563797|147396944|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||F=7.73|Mixed Models Analysis|||Comparison is between baseline and during treatment.||||0.014
73971962|NCT03125070|147484430|OTHER|||||||0.31||||||The threshold for statistical significance was p=0.05|Chi-squared|||Secondary cancer screening healthcare utilization (HCU-SM) at baseline: \>=.80 versus \<.80||||0.31
73971963|NCT03125070|147484431|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
73933511|NCT00563797|147396945|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||F=36.32|Mixed Models Analysis|||Comparison of baseline and post-treatment||||.0001
73933512|NCT00563797|147396946|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Mixed Models Analysis|||||||.025
73933513|NCT00563797|147396947|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Mixed Models Analysis|||||||.019
73933514|NCT04327934|147396948|EQUIVALENCE|We compared groups across treatments||||||0.018|||||||ANOVA|||||||0.018
73933515|NCT04327934|147396949|EQUIVALENCE|We compared across groups and within groups over time.|||||<|0.016|||||||ANOVA|||||||<0.016
73933516|NCT04327934|147396949|EQUIVALENCE|We compared across groups and within groups over time.||||||0.08|||||||ANOVA|||||||0.08
73933517|NCT04327934|147396952|OTHER|||||||0.05||||||Friedman's tests to compare slopes|Friedman's test|||||||0.05
73933518|NCT04327934|147396954|OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
73933519|NCT04327934|147396954|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
73933520|NCT04327934|147396955|EQUIVALENCE|We compared groups across treatments||||||0.0023|||||||ANOVA|||||||0.0023
73933521|NCT04327934|147396956|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
73933522|NCT04327934|147396957|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
73933523|NCT03095417|147396971|SUPERIORITY|||||||0.747|||||||Mixed Models Analysis|||||||0.747
73933524|NCT03095417|147396972|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
73933525|NCT03095417|147396973|SUPERIORITY|||||||0.264|||||||Mixed Models Analysis|||||||0.264
73933526|NCT03095417|147396974|SUPERIORITY|||||||0.511|||||||Mixed Models Analysis|||||||0.511
73933527|NCT03095417|147396975|SUPERIORITY|||||||0.677|||||||Mixed Models Analysis|||||||0.677
73933528|NCT03095417|147396976|SUPERIORITY|||||||0.815|||||||Mixed Models Analysis|||||||0.815
73933529|NCT03095417|147396977|SUPERIORITY|||||||0.719|||||||Mixed Models Analysis|||||||0.719
73933530|NCT03095417|147396978|SUPERIORITY|||||||0.346|||||||Mixed Models Analysis|||||||0.346
73933531|NCT03095417|147396979|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.910
73933532|NCT03095417|147396980|SUPERIORITY|||||||0.794|||||||Mixed Models Analysis|||||||0.794
73971964|NCT03125070|147484432|SUPERIORITY|||||||0.4|||||||Chi-squared|||||||0.40
73971965|NCT04231331|147484466|SUPERIORITY||||||<|0.001||||||P-value \<0.05 was considered statistically significant.|t-test, 2 sided|||Based on our previous study, we assumed a common baseline mean EROA of 0.21 cm2 with a common standard deviation of 0.11 cm2. Given these assumptions, we calculated that a sample size of 204 patients randomly assigned to two groups, would provide 90% power to detect a difference of 0.05 cm2 in the EROA between the ertugliflozin and placebo groups, using a two-sided t test with an alpha level of 0.05.||||<0.001
73865362|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.59||||0.8749|TWO_SIDED|95.0|0.711|3.473|||Mixed Models Analysis|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||3.473|0.711|0.8749
73933533|NCT03095417|147396981|SUPERIORITY|||||||0.626|||||||Mixed Models Analysis|||||||0.626
73933534|NCT03095417|147396982|SUPERIORITY|||||||0.774|||||||Mixed Models Analysis|||||||0.774
73865363|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.99||||0.9566|TWO_SIDED|95.0|0.899|4.342|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||4.342|0.899|0.9566
73957829|NCT03068468|147451198|SUPERIORITY||Difference|0.9||||0.0387|TWO_SIDED|95.0|0.0|1.7|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Letter Number Sequence as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline Letter Number Sequence, baseline Letter Number Sequence by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.7|0.0|0.0387
73971966|NCT01651403|147484475|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||< 0.001
73971967|NCT01651403|147484475|SUPERIORITY||||||<|0.001|||||||Fisher Exact|Fisher's exact test without adjusting for strata at baseline||||||< 0.001
73971968|NCT01651403|147484476|SUPERIORITY|||||||0.935|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||0.935
73971969|NCT01651403|147484477|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||0.001
73865364|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.91||||0.9549|TWO_SIDED|95.0|0.862|4.173|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||4.173|0.862|0.9549
73865365|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.81||||0.9275|TWO_SIDED|95.0|0.816|4.005|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||4.005|0.816|0.9275
73865366|NCT01597635|147276854|SUPERIORITY||Ratio of Active/Placebo|1.32||||0.7483|TWO_SIDED|95.0|0.584|3.007|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||3.007|0.584|0.7483
73865367|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.648|TWO_SIDED|95.0|0.516|2.675|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||2.675|0.516|0.6480
73865368|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.76||||0.9038|TWO_SIDED|95.0|0.741|4.17|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||4.170|0.741|0.9038
73865369|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.38||||0.7339|TWO_SIDED|95.0|0.49|3.915|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||3.915|0.490|0.7339
73865370|NCT01597635|147276854|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.38||||0.7714|TWO_SIDED|95.0|0.651|3.321|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||3.321|0.651|0.7714
74030416|NCT02078713|147615158|SUPERIORITY||Odds Ratio (OR)|1.17||||0.31|TWO_SIDED|95.0|0.86|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of values clarity subscale||1.59|0.86|0.31
73865371|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.07||||1|TWO_SIDED|95.0|0.032|0.14|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.140|0.032|1.0000
73865372|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.1||||1|TWO_SIDED|95.0|0.048|0.209|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.209|0.048|1.0000
73865373|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.11||||1|TWO_SIDED|95.0|0.054|0.243|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.243|0.054|1.0000
73865374|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9996|TWO_SIDED|95.0|0.113|0.547|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.547|0.113|0.9996
73865375|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.13|0.634|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.634|0.130|0.9991
73865376|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.32||||0.9979|TWO_SIDED|95.0|0.149|0.682|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||0.682|0.149|0.9979
73865377|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.19||||1||95.0|0.091|0.417|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.417|0.091|1.0000
73865378|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9998|TWO_SIDED|95.0|0.119|0.539|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.539|0.119|0.9998
73865379|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9985|TWO_SIDED|95.0|0.141|0.666|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.666|0.141|0.9985
73865380|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9977|TWO_SIDED|95.0|0.162|0.73|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.730|0.162|0.9977
73865381|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.22||||0.9999|TWO_SIDED|95.0|0.105|0.468|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.468|0.105|0.9999
73865382|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.26||||0.9996|TWO_SIDED|95.0|0.119|0.57|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.570|0.119|0.9996
73865383|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.82||||0.6621|TWO_SIDED|95.0|0.319|2.136|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||2.136|0.319|0.6621
73865384|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.79||||0.7085|TWO_SIDED|95.0|0.324|1.847|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.847|0.324|0.7085
73865385|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.06||||1|TWO_SIDED|95.0|0.028|0.14|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.140|0.028|1.0000
73865386|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.1||||1|TWO_SIDED|95.0|0.043|0.216|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.216|0.043|1.0000
73865387|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.08||||1|TWO_SIDED|95.0|0.034|0.177|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.177|0.034|1.0000
73865388|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.2||||0.9998|TWO_SIDED|95.0|0.086|0.453|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.453|0.086|0.9998
73865389|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.17||||0.9999|TWO_SIDED|95.0|0.075|0.4|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.400|0.075|0.9999
73865390|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.4||||0.9863|TWO_SIDED|95.0|0.173|0.901|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||0.901|0.173|0.9863
73865391|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9998|TWO_SIDED|95.0|0.103|0.529|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.529|0.103|0.9998
73865392|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.28||||0.9992|TWO_SIDED|95.0|0.119|0.626|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.626|0.119|0.9992
73865393|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9995|TWO_SIDED|95.0|0.102|0.561|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.561|0.102|0.9995
73865394|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9964|TWO_SIDED|95.0|0.131|0.729|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.729|0.131|0.9964
73865395|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9995|TWO_SIDED|95.0|0.107|0.584|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.584|0.107|0.9995
74030417|NCT02078713|147615158|SUPERIORITY||Odds Ratio (OR)|1.06||||0.73|TWO_SIDED|95.0|0.76|1.49||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of support subscale||1.49|0.76|0.73
73865396|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9993|TWO_SIDED|95.0|0.098|0.578|||Ratio of Active/Placebo|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.578|0.098|0.9993
73865397|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9781|TWO_SIDED|95.0|0.119|0.969|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||0.969|0.119|0.9781
73865398|NCT01597635|147276855|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.38||||0.9375|TWO_SIDED|95.0|0.154|1.341|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.341|0.154|0.9375
73865399|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2598|TWO_SIDED|95.0|0.752|1.215|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.215|0.752|0.2598
73865400|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3949|TWO_SIDED|95.0|0.783|1.273|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.273|0.783|0.3949
73865401|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4175|TWO_SIDED|95.0|0.791|1.294|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.294|0.791|0.4175
73865402|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.442|TWO_SIDED|95.0|0.806|1.292|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.292|0.806|0.4420
74030418|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|1.27||||0.12|TWO_SIDED|95.0|0.94|1.72||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pills are more effective than condoms||1.72|0.94|0.12
74088808|NCT01744093|147730631|SUPERIORITY||Proportion (percent)|6.3||||0.002|TWO_SIDED|95.0|0.16|30.2|||Fisher Exact||Exact two-sided 95% Clopper-Pearson confidence interval.|Null hypothesis adverse event rate (grade 2 or higher toxicity) = 45.5%||30.2|0.16|0.002
73865403|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4432|TWO_SIDED|95.0|0.811|1.262|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.262|0.811|0.4432
73865404|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4578|TWO_SIDED|95.0|0.818|1.229|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.229|0.818|0.4578
73865405|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3365|TWO_SIDED|95.0|0.79|1.167|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.167|0.790|0.3365
73865406|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.3339|TWO_SIDED|95.0|0.77|1.163|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.163|0.770|0.3339
73865407|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3608|TWO_SIDED|95.0|0.786|1.166|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.166|0.786|0.3608
73865408|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3584|TWO_SIDED|95.0|0.788|1.168|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.168|0.788|0.3584
73865409|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.1219|TWO_SIDED|95.0|0.725|1.073|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.073|0.725|0.1219
73865410|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4662|TWO_SIDED|95.0|0.814|1.21|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.210|0.814|0.4662
73865411|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5748|TWO_SIDED|95.0|0.828|1.247|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.247|0.828|0.5748
73865412|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.4104|TWO_SIDED|95.0|0.786|1.204|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.204|0.786|0.4104
73865413|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5114|TWO_SIDED|95.0|0.817|1.246|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.246|0.817|0.5114
73865414|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4213|TWO_SIDED|95.0|0.783|1.2|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.200|0.783|0.4213
73865415|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2663|TWO_SIDED|95.0|0.731|1.132|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.132|0.731|0.2663
73933535|NCT01047683|147396988|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.1|||<|0.0001|TWO_SIDED|95.0|-46.6|-21.5||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.01 for the primary endpoint.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A standard deviation of 45% in the TG measurements and a significance level of P \< 0.01 required a sample size of 69 completed patients per treatment group to provide greater than or equal to 90% power to detect a difference of 30% between AMR101 and placebo in the percentage of change from baseline in the fasting TG levels.||-21.5|-46.6|<0.0001
73933536|NCT01047683|147396988|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.7||||0.0051|TWO_SIDED|95.0|-33.3|-5.6|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-5.6|-33.3|0.0051
73933537|NCT01047683|147396989|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-28.6||||0.0005|TWO_SIDED|95.0|-43.4|-13.9||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05 for secondary and exploratory endpoints.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-13.9|-43.4|0.0005
73933538|NCT01047683|147396989|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-15.3||||0.1152|TWO_SIDED|95.0|-30.3|-0.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-0.7|-30.3|0.1152
73933539|NCT01047683|147396990|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-13.6||||0.0006|TWO_SIDED|95.0|-20.2|-6.3||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-6.3|-20.2|0.0006
73933540|NCT01047683|147396990|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.1||||0.2367|TWO_SIDED|95.0|-12.3|2.2|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||2.2|-12.3|0.2367
73933541|NCT01047683|147396991|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.5||||0.0019|TWO_SIDED|95.0|-13.5|-3.2||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-3.2|-13.5|0.0019
73933542|NCT01047683|147396991|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.6||||0.2367|TWO_SIDED|95.0|-7.8|1.9|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||1.9|-7.8|0.2367
73933543|NCT01047683|147396992|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.3||||0.6768|TWO_SIDED|95.0|-12.9|8.1||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||8.1|-12.9|0.6768
73933544|NCT01047683|147396992|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|5.2||||0.3022|TWO_SIDED|95.0|-5.4|15.6|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||15.6|-5.4|0.3022
73971970|NCT01651403|147484479|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
73971971|NCT01651403|147484481|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||0.002
73971972|NCT01651403|147484483|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
73971973|NCT01651403|147484485|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
73971974|NCT01651403|147484487|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
73971975|NCT01651403|147484489|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||<0.001
73971976|NCT01651403|147484491|SUPERIORITY||||||>|0.999|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||>0.999
73971977|NCT01651403|147484499|OTHER|Comparison of the difference in percentages|Exact Chan-Zhang method|11.4|||||TWO_SIDED|95.0|-6.9|25.1||||||||25.1|-6.9|
73971978|NCT01651403|147484500|OTHER|Comparison of the difference in percentages|Exact Chan-Zhang method|11.4|||||TWO_SIDED|95.0|-6.9|25.1||||||||25.1|-6.9|
73971979|NCT01651403|147484501|SUPERIORITY|||||||0.007|||||||ANOVA|two-sided superiority test||||||0.007
73971980|NCT01651403|147484503|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||<0.001
73971981|NCT05622812|147484524|SUPERIORITY||Treatment difference|39.0|||<|0.001|TWO_SIDED|95.0|21.6|56.5||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|||56.5|21.6|<0.001
73933545|NCT01047683|147396993|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.7|||<|0.0001|TWO_SIDED|95.0|-25.0|-11.3||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-11.3|-25.0|<0.0001
73865416|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2373|TWO_SIDED|95.0|0.72|1.142|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.142|0.720|0.2373
73865417|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2575|TWO_SIDED|95.0|0.721|1.149|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.149|0.721|0.2575
73865418|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2173|TWO_SIDED|95.0|0.708|1.127|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.127|0.708|0.2173
73865419|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2406|TWO_SIDED|95.0|0.717|1.143|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.143|0.717|0.2406
73933546|NCT01047683|147396993|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.1||||0.0182|TWO_SIDED|95.0|-15.1|-1.4|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-1.4|-15.1|0.0182
73933547|NCT03698773|147396995|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
73933548|NCT03698773|147396996|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
73933549|NCT00908960|147396997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.7||||0.06|TWO_SIDED|95.0|1.03|43.17|||Fine and Gray regression|||||43.17|1.03|0.06
73933550|NCT05074433|147397000|SUPERIORITY||Hazard Ratio (HR)|0.563|||||TWO_SIDED|95.0|0.093|3.393|||Cox proportional hazard model|||||3.393|0.093|
73971982|NCT05622812|147484525|SUPERIORITY||Treatment difference|40.4|||<|0.001|TWO_SIDED|95.0|23.1|57.6||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||57.6|23.1|<0.001
73865420|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2471|TWO_SIDED|95.0|0.721|1.151|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.151|0.721|0.2471
73865421|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2585|TWO_SIDED|95.0|0.727|1.157|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.157|0.727|0.2585
73865422|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.3101|TWO_SIDED|95.0|0.737|1.17|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.170|0.737|0.3101
73865423|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2476|TWO_SIDED|95.0|0.727|1.16|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.160|0.727|0.2476
73933551|NCT05074433|147397000|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.072|2.929|||Cox proportional hazard model|||||2.929|0.072|
73933552|NCT05074433|147397000|SUPERIORITY||Cox Proportional Hazard|0.609|||||TWO_SIDED|95.0|0.101|3.668|||Cox proportional hazard model|||||3.668|0.101|
73933553|NCT01260922|147397058|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.16|||||TWO_SIDED|90.0|97.07|107.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.51|97.07|
73971983|NCT05622812|147484525|SUPERIORITY||Treatment difference|41.7|||<|0.001|TWO_SIDED|95.0|25.6|57.8||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 9||57.8|25.6|<0.001
73865424|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3887|TWO_SIDED|95.0|0.767|1.222|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.222|0.767|0.3887
73865425|NCT01597635|147276856|SUPERIORITY||Ratio of Active/Placebo|0.92||||0.2294|TWO_SIDED|95.0|0.749|1.146|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.146|0.749|0.2294
73865426|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.8522|TWO_SIDED|95.0|0.916|1.234|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.234|0.916|0.8522
73865427|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5885|TWO_SIDED|95.0|0.89|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.164|0.890|0.5885
73865428|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.8558|TWO_SIDED|95.0|0.94|1.23|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.230|0.940|0.8558
73865429|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.8374|TWO_SIDED|95.0|0.932|1.224|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hour||1.224|0.932|0.8374
73865430|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5886|TWO_SIDED|95.0|0.887|1.152|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.152|0.887|0.5886
73865431|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.7532|TWO_SIDED|95.0|0.918|1.18|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.180|0.918|0.7532
73865432|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7108|TWO_SIDED|95.0|0.906|1.179|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.179|0.906|0.7108
73933554|NCT01260922|147397059|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Slope|94.75|||||TWO_SIDED|90.0|92.11|97.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||97.46|92.11|
73933555|NCT04165291|147397061|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<.01
73933556|NCT04165291|147397062|OTHER|||||||0.08|||||||ANOVA|||||||.08
73933557|NCT04165291|147397063|SUPERIORITY|||||||0.116|||||||Repeated Measures Analysis of Variance|||||||.116
73933558|NCT04165291|147397064|SUPERIORITY||Mean Difference (Final Values)|5.146|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
73933559|NCT04165291|147397065|SUPERIORITY|||||||0.13|||||||ANOVA|||||||.13
73933560|NCT04165291|147397066|SUPERIORITY|||||||0.35|||||||ANOVA|||||||.35
73933561|NCT02248922|147397067|OTHER|||||||0.4099|||||||ANOVA|||||||0.4099
73933562|NCT02248922|147397068|OTHER|||||||0.6961|||||||ANOVA|||||||0.6961
73865433|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7445|TWO_SIDED|95.0|0.918|1.19|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.190|0.918|0.7445
73933563|NCT02248922|147397069|OTHER|||||||0.354|||||||ANOVA|||||||0.3540
73933564|NCT02248922|147397070|OTHER|||||||0.591|||||||ANOVA|||||||0.5910
73933565|NCT02248922|147397071|OTHER|||||||0.4249|||||||ANOVA|||||||0.4249
73933566|NCT02248922|147397072|OTHER|||||||0.3963|||||||ANOVA|||||||0.3963
73933567|NCT02248922|147397073|OTHER|||||||0.3502|||||||ANOVA|||||||0.3502
73933568|NCT02822794|147397074|SUPERIORITY||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 Weeks (GT1) over the performance goal of 50%.||||||<0.001
73933569|NCT02822794|147397074|SUPERIORITY||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL +RBV 24 Weeks (GT1) over the performance goal of 50%.||||||<0.001
73933570|NCT02708745|147397109|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||.29
73933571|NCT02708745|147397110|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
73933572|NCT02708745|147397111|SUPERIORITY|||||||0.78||||||For the barrier 'not having enough time to discuss vaccine concerns', P=0.78. For the barrier 'not realizing until late in visit that parent had vaccine concerns', P=0.37. For the barrier 'not understanding parent specific vaccine concerns', P=0.66.|Chi-squared|||||||0.78
73933573|NCT02480621|147397118|SUPERIORITY||Mean Difference (Net)|1.74|||<|0.1|TWO_SIDED||||||t-test, 2 sided|||||||<0.10
73933574|NCT03056690|147397119|SUPERIORITY|Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (Week 8) as response; treatment, center (pooled where necessary), time (week 8) and treatment\*time as fixed effects, baseline and baseline\*time as covariates.|LSMean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.25||0.086|TWO_SIDED|90.0|-0.76|0.07|||MMRM|||||0.07|-0.76|0.086
73933575|NCT03056690|147397125|SUPERIORITY||Difference|0.2||||0.551|TWO_SIDED|90.0|-11.9|12.5|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||12.5|-11.9|0.551
73933576|NCT03056690|147397126|SUPERIORITY||Difference|6.9||||0.202|TWO_SIDED|90.0|-5.2|19.1|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||19.1|-5.2|0.202
74030419|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.0001|TWO_SIDED|95.0|1.94|3.62||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are more effective than pills||3.62|1.94|<0.0001
73933577|NCT03056690|147397127|SUPERIORITY||Difference|1.7||||0.451|TWO_SIDED|90.0|-10.5|13.8|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||13.8|-10.5|0.451
73933578|NCT03056690|147397128|SUPERIORITY||Difference|6.1||||0.174|TWO_SIDED|90.0|-6.2|18.1|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||18.1|-6.2|0.174
73933579|NCT03056690|147397129|SUPERIORITY||Least Square (LS) Mean difference|-1.48|STANDARD_ERROR_OF_MEAN|2.04||0.235|TWO_SIDED|90.0|-4.86|1.9||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 2||1.90|-4.86|0.235
73933580|NCT03056690|147397129|SUPERIORITY||LSMean Difference|-2.97|STANDARD_ERROR_OF_MEAN|2.34||0.103|TWO_SIDED|90.0|-6.84|0.89||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 4||0.89|-6.84|0.103
73933581|NCT03056690|147397129|SUPERIORITY||LSMean Difference|-2.59|STANDARD_ERROR_OF_MEAN|2.53||0.154|TWO_SIDED|90.0|-6.78|1.6||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 8||1.60|-6.78|0.154
73933582|NCT03056690|147397129|SUPERIORITY||LSMean Difference|-1.34|STANDARD_ERROR_OF_MEAN|1.88||0.238|TWO_SIDED|90.0|-4.45|1.77||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 2||1.77|-4.45|0.238
73933583|NCT03056690|147397129|SUPERIORITY||LSMean Difference|-3.73|STANDARD_ERROR_OF_MEAN|2.11||0.039|TWO_SIDED|90.0|-7.22|-0.24||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 4||-0.24|-7.22|0.039
73933584|NCT03056690|147397129|SUPERIORITY||LSMean Difference|-3.06|STANDARD_ERROR_OF_MEAN|2.34||0.097|TWO_SIDED|90.0|-6.93|0.81||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 8||0.81|-6.93|0.097
73933585|NCT03056690|147397129|SUPERIORITY||LSMean DIfference|-0.99|STANDARD_ERROR_OF_MEAN|0.63||0.057|TWO_SIDED|90.0|-2.03|0.04||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 2||0.04|-2.03|0.057
73933586|NCT03056690|147397129|SUPERIORITY||LSMean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.63||0.018|TWO_SIDED|90.0|-2.39|-0.29||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 4||-0.29|-2.39|0.018
73933587|NCT03056690|147397129|SUPERIORITY||LSMean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.7||0.111|TWO_SIDED|90.0|-2.02|0.3||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 8||0.30|-2.02|0.111
73933588|NCT03056690|147397130|SUPERIORITY||LSMean difference|-3.15|STANDARD_ERROR_OF_MEAN|2.36||0.092|TWO_SIDED|90.0|-7.05|0.75||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Function Subscale||0.75|-7.05|0.092
73933589|NCT03056690|147397130|SUPERIORITY||LSMean difference|-3.29|STANDARD_ERROR_OF_MEAN|2.16||0.065|TWO_SIDED|90.0|-6.85|0.28||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Symptoms subscale||0.28|-6.85|0.065
73933590|NCT03056690|147397130|SUPERIORITY||LSMean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.65||0.049|TWO_SIDED|90.0|-2.15|-0.01||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Overall Impact Subscale.||-0.01|-2.15|0.049
73971984|NCT05622812|147484525|SUPERIORITY||Treatment difference|30.2||||0.003|TWO_SIDED|95.0|13.2|47.1||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||47.1|13.2|0.003
73933591|NCT03056690|147397131|SUPERIORITY|The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Odds Ratio (OR)|1.43||||0.192|TWO_SIDED|90.0|0.91|2.24|||Likelihood test|||Week 2||2.24|0.91|0.192
73933592|NCT03056690|147397131|SUPERIORITY||Odds Ratio (OR)|1.33||||0.285|TWO_SIDED|90.0|0.86|2.07||The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Likelihod test|||Week 4||2.07|0.86|0.285
73933593|NCT03056690|147397131|SUPERIORITY||Odds Ratio (OR)|1.2||||0.486|TWO_SIDED|90.0|0.78|1.87||The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Likelihood test|||EOT||1.87|0.78|0.486
73933594|NCT03056690|147397132|SUPERIORITY|The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test.|Odds Ratio (OR)|1.32||||0.305|TWO_SIDED|90.0|0.85|2.05|||Likelihood test|||Week 8||2.05|0.85|0.305
73933595|NCT01242527|147397137|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-21.68||||0.005|TWO_SIDED|95.0|-40.7|-2.89||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate and treatment and user/non-user of lipid-altering drugs as factors|||-2.89|-40.70|0.005
73933596|NCT01242527|147397137|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-21.19||||0.007|TWO_SIDED|95.0|-40.32|-2.29||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|||-2.29|-40.32|0.007
73933597|NCT01242527|147397137|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-26.6|||<|0.001|TWO_SIDED|95.0|-45.12|-8.38||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|||-8.38|-45.12|<0.001
73933598|NCT00983580|147397169|SUPERIORITY|||||||0.448|||||||Chi-squared|||||||0.448
73971985|NCT05622812|147484526|SUPERIORITY||Treatment difference|99.0|||<|0.001|TWO_SIDED|95.0|97.1|100.0||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 3||100.0|97.1|<0.001
73865434|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.3759|TWO_SIDED|95.0|0.863|1.115|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.115|0.863|0.3759
73865435|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.398|TWO_SIDED|95.0|0.859|1.118|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.118|0.859|0.3980
73933599|NCT00983580|147397170|SUPERIORITY|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||This statistical analysis compares the difference between the number of patients with No adenoma recurrence at 12 months with those with adenoma recurrence at 12 months.||||0.358
73933600|NCT00983580|147397172|SUPERIORITY|||||||0.513|||||||t-test, 2 sided|||||||0.513
73933601|NCT01072201|147397219|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73933602|NCT01072201|147397220|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73933603|NCT01072201|147397221|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups||||0.05
73933604|NCT00360334|147397234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.71|||<|0.001||95.0|2.62|8.46|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the primary outcome divided by the odds of a patient in the insulin glargine arm achieving the primary outcome||8.46|2.62|<0.001
73933605|NCT00360334|147397235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.76|||<|0.001||95.0|3.11|10.64|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||10.64|3.11|<0.001
73933606|NCT00360334|147397236|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73865436|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3231|TWO_SIDED|95.0|0.849|1.103|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.103|0.849|0.3231
73933607|NCT00360334|147397237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.28||95.0|0.44|1.26|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.26|0.44|0.280
73933608|NCT00360334|147397238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.191||95.0|0.42|1.19|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.19|0.42|0.191
73933609|NCT00360334|147397239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.363||95.0|0.66|3.07|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||3.07|0.66|0.363
73933610|NCT00360334|147397241|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
73933611|NCT00360334|147397242|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
73933612|NCT00360334|147397243|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
73933613|NCT00360334|147397244|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
73933614|NCT00360334|147397245|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Repeated Measures|||||||<0.001
73933615|NCT00360334|147397246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.91||||0.001||95.0|3.7|210.54|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||210.54|3.70|0.001
73933616|NCT00360334|147397248|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Mixed Model Repeated Measures|||||||0.014
73933617|NCT00360334|147397249|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Mixed Model Repeated Measures|||||||0.100
73933618|NCT00360334|147397250|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||ANCOVA|||||||0.125
73933619|NCT00360334|147397251|SUPERIORITY_OR_OTHER|||||||0.471||95.0|||||ANCOVA|||||||0.471
73933620|NCT00360334|147397252|SUPERIORITY_OR_OTHER|||||||0.601||95.0|||||ANCOVA|||||||0.601
73933621|NCT00360334|147397253|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||||||0.650
73933622|NCT00360334|147397254|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||ANCOVA|||||||0.017
73933623|NCT00360334|147397255|SUPERIORITY_OR_OTHER|||||||0.667||95.0|||||ANCOVA|||||||0.667
73933624|NCT00360334|147397256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.675||||0.139||95.0|0.401|1.136|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.136|0.401|0.139
73933625|NCT00360334|147397257|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.317||||0.001||95.0|0.159|0.63|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||0.630|0.159|0.001
73933626|NCT00360334|147397258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.797||||0.716||95.0|0.235|2.705|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||2.705|0.235|0.716
73933627|NCT00360334|147397259|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||ANCOVA on ranks|||||||0.113
73933628|NCT00360334|147397260|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA on ranks|||||||<0.001
73933629|NCT00360334|147397261|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANCOVA on ranks|||||||0.740
73933630|NCT03837496|147397279|SUPERIORITY||Slope|-0.66||||0.504|TWO_SIDED|95.0|-2.59|1.27||a priori threshold p\<0.05|ANCOVA|Adjusted for distress and receipt of ovarian suppression.||Analysis comparing the change in monthly adherence to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.||1.27|-2.59|.504
73933631|NCT03837496|147397279|SUPERIORITY||Slope|-0.17||||0.225|TWO_SIDED|95.0|-0.44|-0.1||a priori threshold p\<0.05|ANCOVA|Adjusted for distress and receipt of ovarian suppression||Analysis comparing the change in weekly adherence rates to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.||-0.10|-0.44|.225
73933632|NCT03837496|147397280|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.63|TWO_SIDED|95.0|-0.4|0.66||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in self-reported endocrine therapy adherence between groups on the MARS-5 scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||0.66|-0.40|.630
73933633|NCT03837496|147397281|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.186|TWO_SIDED|95.0|-1.27|6.44||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in satisfaction with adjuvant endocrine therapy between groups on the CTSQ from baseline to 12 weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||6.44|-1.27|.186
73933634|NCT03837496|147397282|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.562|TWO_SIDED|95.0|-3.49|1.91||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in symptom distress between groups on the BCPT scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||1.91|-3.49|.562
73933635|NCT01431508|147397291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||Comparison of Week 12 and Baseline||||<0.05
73933636|NCT00129259|147397292|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|P-value for testing treatment effect uses change in ln(AUC+1) as the outcome variable and adjusts for baseline ln(AUC+1).||"Null hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC does not differ between treatment groups after adjusting for baseline C-peptide AUC.~Alternative hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC differs between the treatment groups after adjusting for baseline values."||||0.002
73933637|NCT00129259|147397293|SUPERIORITY_OR_OTHER|||||||0.697||95.0|||||ANCOVA|ANCOVA adjusts for baseline HbA1c.||"Null hypothesis: The mean change in HbA1c from baseline (pre-treatment) to Month 24 does not differ between treatment groups.~Alternative hypothesis: The mean change in HbA1c from baseline to Month 24 differs between treatment groups."||||0.697
73933638|NCT00129259|147397294|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|ANCOVA adjusts for baseline daily insulin use per kg||"Null hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg does not differ between the treatment and control groups.~Alternative hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg differs between the treatment and control groups."||||0.110
73933639|NCT00023452|147397295|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% confidence interval (CI) was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.24|||||ONE_SIDED|95.0||0.01|||||The difference in cumulative TB disease rate is the rate in the 3RPT/INH arm minus the rate in the 9INH arm.|||0.01||
73933640|NCT00023452|147397296|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Rate|-0.21|||||ONE_SIDED|95.0||0.04|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.04||
73933641|NCT00023452|147397297|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.25|||||ONE_SIDED|95.0||0.03|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.03||
73933642|NCT00023452|147397298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Chi-squared|||||||0.02
73933643|NCT00023452|147397299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24||95.0|||||Chi-squared|||Grade 3 Drug Toxicity||||0.24
73933644|NCT00023452|147397299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||95.0|||||Chi-squared|||Grade 4 Drug Toxicity||||0.59
73933645|NCT00023452|147397300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0|||||Chi-squared|||||||0.22
73933646|NCT00023452|147397302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73933647|NCT00023452|147397303|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
73933648|NCT00023452|147397304|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.19|||||ONE_SIDED|95.0||0.06|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.06||
73865437|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.1245|TWO_SIDED|95.0|0.812|1.056|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.056|0.812|0.1245
73933649|NCT04621500|147397329|OTHER|The sequencing transcriptional profile cannot be analyzed by a statistical method.|||||||||||||||||In this open label study, the RNA sequencing transcription analysis was performed to assess if the transcriptome would be modified by vitamin D supplementation and it uniformaly was.|||
73933650|NCT02451748|147397376|EQUIVALENCE|ANOVA||||||0.5378||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and second visit is as follows.||||0.5378
73933651|NCT02451748|147397376|EQUIVALENCE|ANOVA||||||0.919||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and third visit is as follows.||||0.919
73933652|NCT02451748|147397376|EQUIVALENCE|ANOVA||||||0.4255||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the second and third visit is as follows.||||0.4255
73865438|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4631|TWO_SIDED|95.0|0.87|1.134|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.134|0.870|0.4631
73865439|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.1026|TWO_SIDED|95.0|0.801|1.047|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.047|0.801|0.1026
73865440|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3152|TWO_SIDED|95.0|0.85|1.101|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.101|0.850|0.3152
73933653|NCT02451748|147397376|EQUIVALENCE|ANOVA||||||0.1037||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and second visit is as follows.||||0.1037
73933654|NCT02451748|147397376|EQUIVALENCE|ANOVA||||||0.0008||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and third visit is as follows.||||0.0008
73933655|NCT02451748|147397376|EQUIVALENCE|ANOVA||||||0.0001||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the second and third visit is as follows.||||0.0001
73933656|NCT01175824|147397380|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the upper limit of the 95% confidence interval (CI) of the difference in the LS mean between the two treatment arms (twice-daily insulin lispro Low Mixture minus the comparator arm) at 24 weeks is \<0.4%.|LS mean difference|-0.21|||||TWO_SIDED|95.0|-0.38|-0.04||||||||-0.04|-0.38|
73933657|NCT01175824|147397381|SUPERIORITY_OR_OTHER|||||||0.1858||95.0|||||Mixed Models Analysis|||||||0.1858
73933658|NCT01175824|147397382|SUPERIORITY_OR_OTHER|||||||0.3588||95.0||||HbA1c concentration \<7%|Fisher Exact|||||||0.3588
73865441|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.0762|TWO_SIDED|95.0|0.803|1.035|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.035|0.803|0.0762
73865442|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.0274||95.0|0.763|1.003|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.003|0.763|0.0274
73865443|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.3594|TWO_SIDED|95.0|0.853|1.112|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.112|0.853|0.3594
73933659|NCT01175824|147397382|SUPERIORITY_OR_OTHER|||||||0.5958||95.0||||HbA1c \<=6.5%|Fisher Exact|||||||0.5958
73933660|NCT01175824|147397383|SUPERIORITY_OR_OTHER|||||||0.0827||95.0||||p-value is for the Week 12 comparison|Mixed Models Analysis|||||||0.0827
73933661|NCT01175824|147397383|SUPERIORITY_OR_OTHER|||||||0.5353||95.0||||p-value is for the Week 24 comparison|Mixed Models Analysis|||||||0.5353
73933662|NCT01175824|147397387|SUPERIORITY_OR_OTHER|||||||0.2833||95.0||||p-value is for the comparison at Week 12.|Mixed Models Analysis|||||||0.2833
73933663|NCT01175824|147397387|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||p-value is for the comparison at Week 24.|Mixed Models Analysis|||||||0.0176
73933664|NCT01175824|147397393|SUPERIORITY_OR_OTHER||LS mean difference|-0.22|||||TWO_SIDED|95.0|-0.39|-0.05||||Superiority will be concluded if of 95% CI upper limit for treatment difference (2x-daily insulin lispro LM minus the comparator arm) at 24 wks is \<0%||||-0.05|-0.39|
73933665|NCT04820673|147397402|OTHER||||||<|0.0001||||||P\<0.0001, calculated by t-test, corresponds to baseline response group domain scores in comparison to week-12 domain scores (CFB). CFB is calculated using available matching data for each domain. Higher domain scores indicate higher disease burden.|t-test, 2 sided|||Week 12 vs Baseline||||<.0001
73933666|NCT00767000|147397422|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.51|||<|0.001||95.0|-0.8|-0.22|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.22|-0.80|<0.001
73933667|NCT00767000|147397422|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64|||<|0.001||95.0|-0.93|-0.36|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.36|-0.93|<0.001
73933668|NCT00767000|147397422|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.81|||<|0.001||95.0|-1.1|-0.53|||Contrained longitudinal model|||Analysis for change from baseline to Week 14||-0.53|-1.10|<0.001
73933669|NCT00767000|147397422|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001||95.0|-1.04|-0.46|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.46|-1.04|<0.001
73933670|NCT00767000|147397423|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-36.6|||<|0.001||95.0|-55.6|-17.5|||Constrained longitudial model|||Analysis for change from baseline to Week 14||-17.5|-55.6|<0.001
73933671|NCT00767000|147397423|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-26.7||||0.005||95.0|-45.4|-8.1|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-8.1|-45.4|0.005
73933672|NCT00767000|147397423|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-35.0|||<|0.001||95.0|-54.0|-16.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-16.0|-54.0|<0.001
73933673|NCT00767000|147397423|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-36.9|||<|0.001||95.0|-55.9|-17.9|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-17.9|-55.9|<0.001
73933674|NCT00767000|147397424|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.8||||0.791||95.0|-11.6|15.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||15.2|-11.6|0.791
73865444|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7027|TWO_SIDED|95.0|0.906|1.197|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.197|0.906|0.7027
73865445|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8661|TWO_SIDED|95.0|0.941|1.246|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.246|0.941|0.8661
73865446|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.8084|TWO_SIDED|95.0|0.924|1.228|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.228|0.924|0.8084
73865447|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.9504|TWO_SIDED|95.0|0.976|1.3|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.300|0.976|0.9504
73933675|NCT00767000|147397424|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.3||||0.121||95.0|-2.7|23.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||23.2|-2.7|0.121
73933676|NCT00767000|147397424|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.3||||0.169||95.0|-22.6|4.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||4.0|-22.6|0.169
73933677|NCT00767000|147397424|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.7||||0.321||95.0|-6.6|20.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||20.0|-6.6|0.321
73933678|NCT01163682|147397436|NON_INFERIORITY|"This tests determined the odds of an increase of greater than or equal to 2 points on the BPI-SF worst pain score, from baseline to 16 weeks, among those in the intervention arm (electo-acupuncture), compared to those in the control arm (sham acupuncture). This change was considered to be clinically meaningful.~Null Hypothesis: electro-acupucture does not prevent taxane-induced peripheral neuropathy"|Odds Ratio (OR)|1.16||||0.25|TWO_SIDED|95.0|0.9|1.5|||Regression, Logistic|||||1.50|0.90|0.25
73933679|NCT01163682|147397437|NON_INFERIORITY|This tests determined the odds of an increase of greater than or equal to 5 points on the FACT-NTX scale, from baseline to 16 weeks, among those in the intervention arm (electo-acupuncture), compared to those in the control arm (sham acupuncture). This change was considered to be clinically meaningful.|Odds Ratio (OR)|1.25||||0.09|TWO_SIDED|95.0|0.97|1.62|||Regression, Logistic|||||1.62|0.97|0.09
73933680|NCT00359762|147397438|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority test was based on the upper 1-sided 97.5% CI for the hazard ratio of Exenatide/Glimepiride;the upper bound was compared to 1.25: if \<1.25, the hypothesis that the risk of treatment failure with Exenatide is more than 1.25 times greater than the risk with Glimepiride is rejected.Superiority test was based on the 2-sided 95% CI for the hazard ratio. If CI excludes 1, the hypothesis that the risk of treatment failure with Exenatide is equal to that with Glimepiride is rejected.|Hazard Ratio|0.748||||0.002|TWO_SIDED|95.0|0.623|0.899|||Regression, Cox|Time to treatment failure was modeled using Cox regression with treatment and baseline HbA1c as predictive terms.||The null hypothesis (H0) and alternative hypothesis (H1) for the primary analysis (i.e., non-inferiority) are:H0: hazards of treatment for Exenatide/hazards of treatment for Glimepiride \>=1.25.H1: hazards of treatment for Exenatide/hazards of treatment for Glimepiride \< 1.25. With 527 patients in each arm, the study would have approximately 90% power to conclude non-inferiority of Exenatide to Glimepiride.||0.899|0.623|0.0020
73933681|NCT00359762|147397439|SUPERIORITY_OR_OTHER|||||||0.0315|TWO_SIDED|99.95|||||Log Rank|||Kaplan-Meier survival curves for time to treatment failure were compared between treatment groups using log rank test.||||0.0315
73971986|NCT05622812|147484526|SUPERIORITY||Treatment difference|87.6|||<|0.001|TWO_SIDED|95.0|76.9|98.2||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||98.2|76.9|<0.001
73865448|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.53|TWO_SIDED|95.0|0.871|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.164|0.871|0.5300
73933682|NCT00359762|147397440|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|5.56||0.7648|TWO_SIDED|95.0|-12.58|9.25|||Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||9.25|-12.58|0.7648
73971987|NCT05622812|147484526|SUPERIORITY||Treatment difference|80.5|||<|0.001|TWO_SIDED|95.0|68.6|92.4||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 9||92.4|68.6|<0.001
73933683|NCT00359762|147397441|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.35|STANDARD_ERROR_OF_MEAN|7.399||0.0528|TWO_SIDED|95.0|-28.88|0.17|||ANCOVA|||Change in HOMA-B from baseline to endpoint was analyzed by an analysis of covariance (ANCOVA) model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||0.17|-28.88|0.0528
73933684|NCT00359762|147397442|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.904|TWO_SIDED|95.0|-0.07|0.06|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.06|-0.07|0.9040
73933685|NCT00359762|147397443|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.017||0.25|TWO_SIDED|95.0|-0.05|0.01|||ANCOVA|||Change in fasting proinsulin/insulin ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||0.01|-0.05|0.2500
73933686|NCT00359762|147397444|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|4.497||0.9001|TWO_SIDED|95.0|-9.4|8.27|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||8.27|-9.40|0.9001
73971988|NCT05622812|147484526|SUPERIORITY||Treatment difference|73.7|||<|0.001|TWO_SIDED|95.0|61.9|85.5||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||85.5|61.9|<0.001
73971989|NCT05622812|147484527|SUPERIORITY||Treatment difference|93.1|||<|0.001|TWO_SIDED|95.0|88.2|98.0||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 3||98.0|88.2|<0.001
73971990|NCT05622812|147484527|SUPERIORITY||Treatment difference|87.9|||<|0.001|TWO_SIDED|95.0|81.4|94.3||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||94.3|81.4|<0.001
73865449|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8595|TWO_SIDED|95.0|0.942|1.243|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.243|0.942|0.8595
73971991|NCT05622812|147484527|SUPERIORITY||Treatment difference|80.4|||<|0.001|TWO_SIDED|95.0|72.7|88.1||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|||88.1|72.7|<0.001
73971992|NCT05622812|147484527|SUPERIORITY||Treatment difference|71.6|||<|0.001|TWO_SIDED|95.0|62.8|80.3||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||80.3|62.8|<0.001
73971993|NCT03916185|147484528|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-32.0|32.0||Statistical significance level of 0.05 was used. No adjustment for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||32|-32|>0.99
73971994|NCT03916185|147484528|SUPERIORITY||Difference in proportions|-15.0||||0.53|TWO_SIDED|95.0|-46.0|18.0||Statistical significance level of 0.05 used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-46|0.53
73971995|NCT03916185|147484528|SUPERIORITY||Difference in proportions|16.0||||0.66|TWO_SIDED|95.0|-29.0|52.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||52|-29|0.66
73971996|NCT03916185|147484529|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-20.0|20.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||20|-20|>0.99
73971997|NCT03916185|147484529|SUPERIORITY||Difference in proportions|-5.0|||>|0.99|TWO_SIDED|95.0|-25.0|13.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||13|-25|>0.99
73971998|NCT03916185|147484529|SUPERIORITY||Difference in proportions|-5.0|||>|0.99|TWO_SIDED|95.0|-26.0|34.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||34|-26|>0.99
73971999|NCT03916185|147484530|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-18.0|18.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-18|>0.99
73865450|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.8802|TWO_SIDED|95.0|0.943|1.261|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.261|0.943|0.8802
73972000|NCT03916185|147484530|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-18.0|18.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-18|>0.99
73972001|NCT03916185|147484530|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-17.0|41.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||41|-17|>0.99
73972002|NCT03916185|147484531|SUPERIORITY||Difference in proportions|61.0|||<|0.001|TWO_SIDED|95.0|27.0|83.0||Statistical significance level of 0.05 was used. No adjustment for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||83|27|<0.001
73972003|NCT03916185|147484531|SUPERIORITY||Difference in proportions|56.0|||<|0.001|TWO_SIDED|95.0|22.0|79.0|||Fisher Exact|Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Comparison was vaccine arm - placebo.|||79|22|<0.001
73972004|NCT03916185|147484531|SUPERIORITY||Difference in proportions|56.0||||0.011|TWO_SIDED|95.0|9.0|86.0|||Fisher Exact|Statistical significance level of 0.05 was used. No adjustments were made for multiple comparisons.|Comparison was vaccine arm - placebo.|||86|9|0.011
73972005|NCT03916185|147484531|SUPERIORITY||Difference in proportions|6.0|||>|0.99|TWO_SIDED|95.0|-25.0|36.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 6120/ΔNS2/1030s Vaccine.|||36|-25|>0.99
73972006|NCT03916185|147484531|SUPERIORITY||Difference in proportions|5.0|||>|0.99|TWO_SIDED|95.0|-31.0|48.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 276 Vaccine.|||48|-31|>0.99
73972007|NCT03916185|147484531|SUPERIORITY||Difference in proportions|-1.0|||>|0.99|TWO_SIDED|95.0|-38.0|44.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV 6120/ΔNS2/1030s Vaccine - RSV 276 Vaccine.|||44|-38|>0.99
73972008|NCT03916185|147484532|SUPERIORITY||Difference in proportions|73.0|||<|0.001|TWO_SIDED|95.0|44.0|91.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||91|44|<0.001
73865451|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.11||||0.9232|TWO_SIDED|95.0|0.958|1.278|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.278|0.958|0.9232
73972009|NCT03916185|147484532|SUPERIORITY||Difference in proportions|61.0|||<|0.001|TWO_SIDED|95.0|27.0|83.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||83|27|<0.001
73972010|NCT03916185|147484532|SUPERIORITY||Difference in proportions|85.0|||<|0.001|TWO_SIDED|95.0|42.0|97.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||97|42|<0.001
73972011|NCT03916185|147484532|SUPERIORITY||Difference in proportions|12.0||||0.66|TWO_SIDED|95.0|-17.0|40.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 6120/ΔNS2/1030s Vaccine.|||40|-17|0.66
73972012|NCT03916185|147484532|SUPERIORITY||Difference in proportions|-12.0|||>|0.99|TWO_SIDED|95.0|-36.0|30.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 276 Vaccine.|||30|-36|>0.99
73972013|NCT03916185|147484532|SUPERIORITY||Difference in proportions|-24.0||||0.28|TWO_SIDED|95.0|-50.0|20.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV 6120/ΔNS2/1030s Vaccine - RSV 276 Vaccine.|||20|-50|0.28
73972014|NCT03916185|147484533|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
73972015|NCT03916185|147484533|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
73865452|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.7911|TWO_SIDED|95.0|0.902|1.256|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.256|0.902|0.7911
73865453|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.28||||0.9946|TWO_SIDED|95.0|1.059|1.514|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.514|1.059|0.9946
73865454|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.983|TWO_SIDED|95.0|1.019|1.444|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.444|1.019|0.9830
73865455|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8024|TWO_SIDED|95.0|0.91|1.261|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.261|0.910|0.8024
73933687|NCT00359762|147397445|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|11.19|STANDARD_ERROR_OF_MEAN|4.966||0.0246|TWO_SIDED|95.0|1.44|20.95|||ANCOVA|||Change in DI30/DG30 ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||20.95|1.44|0.0246
73933688|NCT00359762|147397446|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|1.598||0.0036|TWO_SIDED|95.0|1.53|7.81|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||7.81|1.53|0.0036
73933689|NCT00359762|147397447|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|7.33|STANDARD_ERROR_OF_MEAN|2.128||0.0006|TWO_SIDED|95.0|3.15|11.5|||ANCOVA|||Change in disposition index from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||11.50|3.15|0.0006
73933690|NCT00359762|147397448|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0128|TWO_SIDED|95.0|-0.31|-0.04|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.04|-0.31|0.0128
73933691|NCT00359762|147397449|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.0015|TWO_SIDED|95.0|-0.26|-0.06|||ANCOVA|||Change in HbA1c from baseline to endpoint was analyzed by an ANCOVA model that includes treatment as factor and baseline value as a covariate.||-0.06|-0.26|0.0015
73933692|NCT00359762|147397450|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.174|<|0.0001|TWO_SIDED|95.0|-1.03|-0.34|||Mixed Models Analysis|||MMRM includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.34|-1.03|<.0001
73933693|NCT00359762|147397451|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.183||0.0109|TWO_SIDED|95.0|-0.83|-0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||-0.11|-0.83|0.0109
73933694|NCT00359762|147397452|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.424|<|0.0001|TWO_SIDED|95.0|-3.64|-1.97|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-1.97|-3.64|<.0001
73933695|NCT00359762|147397453|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|0.327|<|0.0001|TWO_SIDED|95.0|-2.84|-1.55|||ANCOVA|||Change in postprandial (2 hours) plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||-1.55|-2.84|<.0001
73933696|NCT00359762|147397454|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|0.463|<|0.0001|TWO_SIDED|95.0|-6.31|-4.49|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction and baseline value as a covariate. The unstructured covariance matrix was used.||-4.49|-6.31|<.0001
73865456|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4806|TWO_SIDED|95.0|0.843|1.166|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.166|0.843|0.4806
73933697|NCT00359762|147397455|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|1.228|<|0.0001|TWO_SIDED|95.0|-7.61|-2.79|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-2.79|-7.61|<.0001
73933698|NCT00359762|147397456|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.75||0.0228|TWO_SIDED|95.0|-3.18|-0.24|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.24|-3.18|0.0228
73933699|NCT00359762|147397457|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.805||0.3737|TWO_SIDED|95.0|-2.3|0.86|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and visit by treatment interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.86|-2.30|0.3737
73933700|NCT00359762|147397458|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.089||0.0042|TWO_SIDED|95.0|-0.43|-0.08|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.08|-0.43|0.0042
73933701|NCT00359762|147397459|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.079||0.7914|TWO_SIDED|95.0|-0.13|0.18|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.18|-0.13|0.7914
73972016|NCT03916185|147484533|SUPERIORITY||||||<|0.001||||||Statistical significance of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
73972017|NCT03916185|147484533|SUPERIORITY|||||||0.95||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.95
73972018|NCT03916185|147484533|SUPERIORITY|||||||0.12||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.12
73865457|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.6658|TWO_SIDED|95.0|0.869|1.223|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.223|0.869|0.6658
73865458|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.03||||0.6131|TWO_SIDED|95.0|0.856|1.212|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.212|0.856|0.6131
73865459|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5795|TWO_SIDED|95.0|0.856|1.197|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.197|0.856|0.5795
73933702|NCT00359762|147397460|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.019||0.0011|TWO_SIDED|95.0|0.02|0.1|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.10|0.02|0.0011
73933703|NCT00359762|147397461|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.22|0.37|||Negative Binomial Model|||The number of hypoglycemic episodes by patient were compared between treatment groups using a negative binomial model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.||0.37|0.22|<.0001
73933704|NCT00359762|147397462|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.141||0.0508|TWO_SIDED|95.0|0.0|0.55|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value at Period III as a covariate. The compound symmetric covariance structure was assumed.||0.55|-0.00|0.0508
73933705|NCT02652780|147397468|SUPERIORITY||Mean Difference (Net)|-0.008||||0.8783|TWO_SIDED|95.0|-0.119|0.102|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.||0.102|-0.119|0.8783
73933706|NCT01172938|147397480|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.0||||0.0001|TWO_SIDED|95.0|9.7|28.3|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||28.3|9.7|0.0001
73933707|NCT01172938|147397480|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.3||||0.0166|TWO_SIDED|95.0|2.2|20.4|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||20.4|2.2|0.0166
73933708|NCT01172938|147397481|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.159||||0.0017|TWO_SIDED|95.0|-0.258|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.060|-0.258|0.0017
73933709|NCT01172938|147397481|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.113||||0.0252|TWO_SIDED|95.0|-0.211|-0.014|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.014|-0.211|0.0252
73933710|NCT01172938|147397482|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|22.2|||<|0.0001|TWO_SIDED|95.0|13.4|30.9||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||30.9|13.4|<0.0001
73865460|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.0209|TWO_SIDED|95.0|0.716|0.993|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||0.993|0.716|0.0209
73865461|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4823|TWO_SIDED|95.0|0.83|1.187|||Mixed Models Analysis|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.187|0.830|0.4823
73865462|NCT01597635|147276856|SUPERIORITY_OR_OTHER||0.0406|0.85||||0.0406|TWO_SIDED|95.0|0.703|1.021|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.021|0.703|0.0406
73865463|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5186|TWO_SIDED|95.0|0.844|1.169|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.169|0.844|0.5186
73933711|NCT01172938|147397482|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.4||||0.0038|TWO_SIDED|95.0|4.2|20.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||20.7|4.2|0.0038
73933712|NCT01172938|147397483|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.182||||0.0005|TWO_SIDED|95.0|-0.283|-0.08||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.080|-0.283|0.0005
73933713|NCT01172938|147397483|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.135||||0.0091|TWO_SIDED|95.0|-0.236|-0.034||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.034|-0.236|0.0091
73933714|NCT01172938|147397484|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.42||||0.0056|TWO_SIDED|95.0|0.71|4.13||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.13|0.71|0.0056
73933715|NCT01172938|147397484|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7||||0.0504|TWO_SIDED|95.0|0.0|3.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.40|-0.00|0.0504
73933716|NCT01172938|147397485|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.7||||0.0017|TWO_SIDED|95.0|6.6|26.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.8|6.6|0.0017
73933717|NCT01172938|147397485|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.9|||||TWO_SIDED|95.0|-1.2|18.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.9|-1.2|
73933718|NCT01172938|147397486|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.9||||0.0023|TWO_SIDED|95.0|-12.9|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.8|-12.9|0.0023
73933719|NCT01172938|147397486|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.8|||||TWO_SIDED|95.0|-10.8|-0.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.7|-10.8|
73933720|NCT01172938|147397487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-1.2|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.4|-1.2|
73865464|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.387|TWO_SIDED|95.0|0.824|1.132|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.132|0.824|0.3870
73933721|NCT01172938|147397487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.3|
73933722|NCT01172938|147397488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|||||TWO_SIDED|95.0|-1.1|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.4|-1.1|
73933723|NCT01172938|147397488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.3|
73972019|NCT03916185|147484533|SUPERIORITY|||||||0.033||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.033
73972020|NCT03916185|147484534|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
73972021|NCT03916185|147484534|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
73972022|NCT03916185|147484534|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
73972023|NCT03916185|147484534|SUPERIORITY|||||||0.39||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.39
73972024|NCT03916185|147484534|SUPERIORITY|||||||0.15||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.15
73972025|NCT03916185|147484534|SUPERIORITY|||||||0.049||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.049
74008297|NCT03627767|147566493|SUPERIORITY||Difference in percentage|18.2|||||TWO_SIDED|95.0|9.8|26.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.6|9.8|
73865465|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.1281|TWO_SIDED|95.0|0.77|1.065|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.065|0.770|0.1281
73865466|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4754|TWO_SIDED|95.0|0.837|1.181|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.181|0.837|0.4754
73933724|NCT01172938|147397489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.88|||||TWO_SIDED|95.0|-7.41|-2.34|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-2.34|-7.41|
73933725|NCT01172938|147397489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.39|||||TWO_SIDED|95.0|-6.92|-1.86|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-1.86|-6.92|
73933726|NCT01172938|147397490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|||||TWO_SIDED|95.0|-0.76|-0.31|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.31|-0.76|
73933727|NCT01172938|147397490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||||TWO_SIDED|95.0|-0.7|-0.25|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.25|-0.70|
73933728|NCT01172938|147397491|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.33|||||TWO_SIDED|95.0|0.43|4.23|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||4.23|0.43|
73933729|NCT01172938|147397491|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|||||TWO_SIDED|95.0|-1.77|2.03|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||2.03|-1.77|
73933730|NCT01172938|147397492|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.56|||||TWO_SIDED|95.0|1.72|5.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||5.40|1.72|
73933731|NCT01172938|147397492|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.04|||||TWO_SIDED|95.0|0.21|3.88|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||3.88|0.21|
73933732|NCT01172938|147397493|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|24.6|||||TWO_SIDED|95.0|15.2|34.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||34.0|15.2|
73933733|NCT01172938|147397493|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.4|||||TWO_SIDED|95.0|3.4|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.5|3.4|
73933734|NCT01172938|147397494|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-10.6|||||TWO_SIDED|95.0|-15.4|-5.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-5.7|-15.4|
73933735|NCT01172938|147397494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.1|||||TWO_SIDED|95.0|-12.0|-2.2|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-2.2|-12.0|
73865467|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5627|TWO_SIDED|95.0|0.856|1.217|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.217|0.856|0.5627
73865468|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5552|TWO_SIDED|95.0|0.848|1.22|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.220|0.848|0.5552
73865469|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.503|TWO_SIDED|95.0|0.843|1.201|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.201|0.843|0.5030
73865470|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5558|TWO_SIDED|95.0|0.84|1.218|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.218|0.840|0.5558
73865471|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.2709|TWO_SIDED|95.0|0.769|1.135|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.135|0.769|0.2709
73933736|NCT01172938|147397495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|||||TWO_SIDED|95.0|-1.6|0.0|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.0|-1.6|
73933737|NCT01172938|147397495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|-0.8|||||TWO_SIDED|95.0|-1.6|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.1|-1.6|
73933738|NCT01172938|147397496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.2|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.2|
73865472|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4143|TWO_SIDED|95.0|0.795|1.208|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.208|0.795|0.4143
73865473|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.7886|TWO_SIDED|95.0|0.891|1.348|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.348|0.891|0.7886
73933739|NCT01172938|147397496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.1|-1.5|
73933740|NCT01172938|147397497|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-6.38|||||TWO_SIDED|95.0|-9.0|-3.75|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-3.75|-9.00|
73865474|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.7607|TWO_SIDED|95.0|0.885|1.353|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.353|0.885|0.7607
73865475|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.8677|TWO_SIDED|95.0|0.922|1.4|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.400|0.922|0.8677
73865476|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.7012|TWO_SIDED|95.0|0.847|1.302|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.302|0.847|0.7012
73865477|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5156|TWO_SIDED|95.0|0.805|1.23|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.230|0.805|0.5156
73865478|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3524|TWO_SIDED|95.0|0.783|1.178|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.178|0.783|0.3524
73865479|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.638|TWO_SIDED|95.0|0.845|1.292|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.292|0.845|0.6380
73865480|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.4003|TWO_SIDED|95.0|0.743|1.241|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.241|0.743|0.4003
73865481|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.16||||0.8817|TWO_SIDED|95.0|0.907|1.502|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.502|0.907|0.8817
73865482|NCT01597635|147276856|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.14||||0.8145|TWO_SIDED|95.0|0.804|1.505|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.505|0.804|0.8145
73865483|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6468|TWO_SIDED|95.0|0.765|1.321|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.321|0.765|0.6468
73865484|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.1965|TWO_SIDED|95.0|0.658|1.136|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.136|0.658|0.1965
73865485|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.1681|TWO_SIDED|95.0|0.694|1.129|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.129|0.694|0.1681
73865486|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.0877|TWO_SIDED|95.0|0.669|1.075|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.075|0.669|0.0877
73865487|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2011|TWO_SIDED|95.0|0.715|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.159|0.715|0.2011
73865488|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6855|TWO_SIDED|95.0|0.842|1.345|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.345|0.842|0.6855
73865489|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.6093|TWO_SIDED|95.0|0.8|1.325|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.325|0.800|0.6093
73865490|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.435|TWO_SIDED|95.0|0.765|1.253|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.253|0.765|0.4350
73865491|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2232|TWO_SIDED|95.0|0.722|1.195|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.195|0.722|0.2232
73865492|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2716|TWO_SIDED|95.0|0.733|1.2|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.200|0.733|0.2716
73865493|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2866|TWO_SIDED|95.0|0.726|1.19|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.190|0.726|0.2866
73865494|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5033|TWO_SIDED|95.0|0.78|1.27|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.270|0.780|0.5033
73865495|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.1493|TWO_SIDED|95.0|0.684|1.12|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.120|0.684|0.1493
73865496|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4947|TWO_SIDED|95.0|0.759|1.301|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.301|0.759|0.4947
73865497|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.89||||0.1951|TWO_SIDED|95.0|0.678|1.161|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.161|0.678|0.1951
73865498|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.8||||0.0512|TWO_SIDED|95.0|0.612|1.05|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.050|0.612|0.0512
73865499|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.47|TWO_SIDED|95.0|0.775|1.279|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.279|0.775|0.4700
73865500|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.634|TWO_SIDED|95.0|0.811|1.368|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.368|0.811|0.6340
74030420|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0004|TWO_SIDED|95.0|1.29|2.44||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - depo is more effective than condoms||2.44|1.29|0.0004
73933741|NCT01172938|147397497|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-4.41|||||TWO_SIDED|95.0|-7.03|-1.79|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-1.79|-7.03|
73933742|NCT01172938|147397498|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-0.94|-0.46|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.46|-0.94|
73933743|NCT01172938|147397498|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||||TWO_SIDED|95.0|-0.7|-0.22|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.22|-0.70|
73933744|NCT01172938|147397499|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|2.21|||||TWO_SIDED|95.0|0.32|4.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||4.10|0.32|
73933745|NCT01172938|147397499|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|0.4|||||TWO_SIDED|95.0|-1.5|2.29|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||2.29|-1.50|
73933746|NCT01172938|147397500|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|3.3|||||TWO_SIDED|95.0|-10.1|16.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.7|-10.1|
73933747|NCT01172938|147397500|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.3|||||TWO_SIDED|95.0|-6.5|21.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.1|-6.5|
73933748|NCT01172938|147397501|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|2.9|||||TWO_SIDED|95.0|-13.4|19.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.3|-13.4|
73933749|NCT01172938|147397501|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.7|||||TWO_SIDED|95.0|-9.1|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.6|-9.1|
73933750|NCT01172938|147397502|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.2|||||TWO_SIDED|95.0|9.0|29.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||29.3|9.0|
73933751|NCT01172938|147397502|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.6|||||TWO_SIDED|95.0|6.4|26.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.8|6.4|
73933752|NCT01172938|147397503|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|13.2|||||TWO_SIDED|95.0|-0.1|26.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.5|-0.1|
73933753|NCT01172938|147397503|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.3|||||TWO_SIDED|95.0|-2.4|25.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||25.0|-2.4|
73933754|NCT01172938|147397504|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.9|||||TWO_SIDED|95.0|-6.8|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.6|-6.8|
73933755|NCT01172938|147397504|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.7|||||TWO_SIDED|95.0|-8.7|24.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.2|-8.7|
73933756|NCT01172938|147397505|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|26.3|||||TWO_SIDED|95.0|17.1|35.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||35.5|17.1|
73933757|NCT01172938|147397505|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.2|||||TWO_SIDED|95.0|5.4|23.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||23.1|5.4|
73933758|NCT01172938|147397506|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|10.3|||||TWO_SIDED|95.0|3.7|16.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.8|3.7|
73933759|NCT01172938|147397506|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.5|||||TWO_SIDED|95.0|3.0|16.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.0|3.0|
74039883|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1859|TWO_SIDED|95.0|-0.54|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.54|0.1859
73972026|NCT02844465|147484552|NON_INFERIORITY|A non-inferiority test will be performed using a paired t-test, with a non-inferiority delta (δ) of one Reliable Change Index (RCI) of 5 points, to test the hypothesis of no reduction. A two-tailed alpha of 0.05 will be used.|||||<|0.0001|||||||Paired t-test|||"It is hypothesized that the Boston Naming Test score will not decrease from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: μ (V-BNT - BSL-BNT) + δ ≤ 0 Alternate Hypothesis: μ (V-BNT - BSL-BNT) + δ \> 0 Where μ (V-BNT - BSL-BNT) = mean difference in the Boston Naming Test score from baseline to Month 12 post Visualase."||||<0.0001
73972027|NCT02844465|147484553|NON_INFERIORITY|A non-inferiority test will be performed using a paired t-test, with a non-inferiority delta (δ) of one Reliable Change Index (RCI) of 15 points, to test the hypothesis of no reduction. A two-tailed alpha of 0.05 will be used.|||||<|0.0001|||||||Paired t-test|||"It is hypothesized that the Rey Auditory Verbal Learning Test 5-Trial Total score will not decrease from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: μ (V-RAVLT - BSL-RAVLT) + δ ≤ 0 Alternate Hypothesis: μ (V-RAVLT - BSL-RAVLT) + δ \> 0 Where μ (V-RAVLT - BSL-RAVLT) = mean difference in the Rey Auditory Verbal Learning Test 5-Trial Total score from baseline to Month 12 post Visualase."||||<0.0001
73972028|NCT02844465|147484554|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.|||||<|0.0001|||||||Sign test|||"It is hypothesized that the QOLIE-31 score will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-QOLIE-31 - BSL-QOLIE-31) ≤ 0 Alternate Hypothesis: M (V-QOLIE-31 - BSL-QOLIE-31) \> 0 Where M (V-QOLIE-31 - BSL-QOLIE-31) = sign-test statistic (\[increases-decreases\]/2) in the Quality of Life in Epilepsy inventory from baseline to Month 12 post Visualase."||||<0.0001
73972029|NCT02844465|147484555|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.||||||0.0004|||||||Sign test|||"It is hypothesized that the SF-36 Mental Component Score (MCS) will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-SF-36 - BSL-SF-36-MCS) ≤ 0 Alternate Hypothesis: M (V-SF-36 - BSL-SF-36-MCS) \> 0 Where M (V- SF-36-MCS - BSL- SF-36-MCS) = sign-test statistic (\[increases-decreases\]/2) in the SF-36 quality of life questionnaire MCS from baseline to Month 12 post Visualase."||||0.0004
73972030|NCT02844465|147484556|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.|||||<|0.0001|||||||Sign test|||"It's hypothesized that the SF-36 Physical Component Score (PCS) will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-SF-36-PCS - BSL-SF-36-PCS) ≤ 0 Alternate Hypothesis: M (V-SF-36-PCS - BSL-SF-36-PCS) \> 0 Where M (V-SF-36-PCS - BSL- SF-36-PCS) = sign-test statistic (\[increases-decreases\]/2) in the SF-36 quality of life questionnaire PCS from baseline to Month 12 post Visualase."||||<0.0001
73972031|NCT02844465|147484557|NON_INFERIORITY|"The hypotheses associated with this endpoint are:~Null Hypothesis: π V - 64% + δ ≤ 0 Alternate Hypothesis: π V - 64% + δ \> 0 Where πV is the proportion of subjects treated with Visualase experiencing no seizures.~An exact 95% CI for the percentage of subjects who are seizure free will be calculated and its lower boundary compared to zero after subtraction of the historical open surgical resection percentage of 64% and the addition of the equivalence delta percentage of 10%."|Proportion of Participants|56.0|||||TWO_SIDED|95.0|46.2|65.8||||||||65.8|46.2|
73972032|NCT03952338|147484572|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.97|TWO_SIDED|95.0|-4.07|3.93|||Mixed Models Analysis|||||3.93|-4.07|0.97
74030421|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0002|TWO_SIDED|95.0|1.36|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are an option for nulliparous young women||2.71|1.36|0.0002
73933760|NCT01172938|147397507|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|3.1|||||TWO_SIDED|95.0|-0.4|6.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.5|-0.4|
73933761|NCT01172938|147397507|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|4.8|||||TWO_SIDED|95.0|0.8|8.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||8.7|0.8|
73972033|NCT03952338|147484573|SUPERIORITY||Mean Difference (Final Values)|1.22||||0.57|TWO_SIDED|95.0|-3.0|5.44|||Mixed Models Analysis|||||5.44|-3.00|0.57
73972034|NCT03952338|147484574|SUPERIORITY||Mean Difference (Final Values)|1.96||||0.09|TWO_SIDED|95.0|-0.32|4.23|||Mixed Models Analysis|||||4.23|-0.32|0.09
73972035|NCT03952338|147484575|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.08|TWO_SIDED|95.0|-0.22|4.43|||Mixed Models Analysis|||||4.43|-0.22|0.08
73972036|NCT03952338|147484576|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.09|TWO_SIDED|95.0|-0.17|2.46|||Mixed Models Analysis|||||2.46|-0.17|0.09
73972037|NCT03952338|147484577|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.95|TWO_SIDED|95.0|-1.39|1.3|||Mixed Models Analysis|||||1.30|-1.39|0.95
73972038|NCT03952338|147484578|SUPERIORITY||Odds Ratio (OR)|0.21||||0.01|TWO_SIDED|95.0|0.06|0.7|||Regression, Logistic|||||0.70|0.06|0.01
73972039|NCT03952338|147484579|SUPERIORITY||Odds Ratio (OR)|0.29||||0.04|TWO_SIDED|95.0|0.09|0.96|||Regression, Logistic|||||0.96|0.09|0.04
73865501|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2129|TWO_SIDED|95.0|0.689|1.183|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.183|0.689|0.2129
73933762|NCT01172938|147397508|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.9|||||TWO_SIDED|95.0|8.3|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.5|8.3|
73972040|NCT03952338|147484580|SUPERIORITY||Odds Ratio (OR)|2.11||||0.236|TWO_SIDED|95.0|0.27|7.23|||Regression, Logistic|||||7.23|0.27|0.236
73933763|NCT01172938|147397508|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|10.1|||||TWO_SIDED|95.0|4.0|16.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.1|4.0|
73933764|NCT01172938|147397509|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.5|||||TWO_SIDED|95.0|4.8|14.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||14.2|4.8|
73933765|NCT01172938|147397509|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|4.7|||||TWO_SIDED|95.0|1.2|8.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||8.3|1.2|
73933766|NCT01172938|147397510|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.6|||||TWO_SIDED|95.0|-2.8|17.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.9|-2.8|
73933767|NCT01172938|147397510|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.9|||||TWO_SIDED|95.0|0.8|23.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||23.0|0.8|
73933768|NCT01172938|147397511|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-1.4|||||TWO_SIDED|95.0|-17.7|14.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||14.8|-17.7|
73933769|NCT01172938|147397511|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|2.4|||||TWO_SIDED|95.0|-14.8|19.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.6|-14.8|
73933770|NCT01172938|147397512|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.4|||||TWO_SIDED|95.0|6.6|28.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||28.2|6.6|
73972041|NCT03952338|147484581|SUPERIORITY||Odds Ratio (OR)|2.22||||0.22|TWO_SIDED|95.0|0.62|7.97|||Regression, Logistic|||||7.97|0.62|0.220
73972042|NCT03952338|147484582|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.7|TWO_SIDED|95.0|-0.37|0.55|||Mixed Models Analysis|||Total vegetables||0.55|-0.37|0.70
73972043|NCT03952338|147484582|SUPERIORITY||Median Difference (Final Values)|-0.07||||0.85|TWO_SIDED|95.0|-0.84|0.69|||Mixed Models Analysis|||Greens and beans||0.69|-0.84|0.85
73972044|NCT03952338|147484582|SUPERIORITY|Total fruits|Mean Difference (Final Values)|0.34||||0.29|TWO_SIDED|95.0|-0.29|0.98|||Mixed Models Analysis|||||0.98|-0.29|0.29
73865502|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6418|TWO_SIDED|95.0|0.798|1.411|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.411|0.798|0.6418
73933771|NCT01172938|147397512|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.8|||||TWO_SIDED|95.0|5.6|27.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||27.9|5.6|
73933772|NCT01172938|147397513|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|5.8|||||TWO_SIDED|95.0|-10.7|22.4|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.4|-10.7|
73933773|NCT01172938|147397513|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.8|||||TWO_SIDED|95.0|-8.5|26.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.2|-8.5|
73933774|NCT04188041|147397536|OTHER|see above||||||0.02|||||||Wilcoxon signed rank test|||Non-parametric Wilcoxon signed rank test for paired data was used to test for significant change in confidence.||||0.02
73933775|NCT01958918|147397555|SUPERIORITY|||||||0.185|||||||ANOVA|||||||0.1850
73933776|NCT00659269|147397571|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
73933777|NCT00718042|147397575|SUPERIORITY_OR_OTHER||Specificity|99.86|||||TWO_SIDED|95.0|99.79|99.91|||Point Estimate||Numerator = All blood donors tested nonreactive from all True Negative blood donors (16,223) Denominator = All True Negative blood donors (16,246) True Negative excludes donor specimens positive by supplemental testing (3)|||99.91|99.79|
73933778|NCT00718042|147397577|SUPERIORITY_OR_OTHER||Point estimate|100.0|||||TWO_SIDED|95.0|96.7|100.0|||Sensitivity|||||100.00|96.70|
73933779|NCT00718042|147397580|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|97.4|99.8|||Percentage Negative|||||99.8|97.4|
73933780|NCT02443298|147397584|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.0255|TWO_SIDED|80.0|1.18|1.81|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.||1.81|1.18|0.0255
73972045|NCT03952338|147484582|SUPERIORITY||Median Difference (Final Values)|0.6||||0.07|TWO_SIDED|95.0|-0.06|1.26|||Mixed Models Analysis|||Whole fruits||1.26|-0.06|0.07
73972046|NCT03952338|147484582|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.92|TWO_SIDED|95.0|-1.16|1.05|||Mixed Models Analysis|||Whole grains||1.05|-1.16|0.92
73972047|NCT03952338|147484582|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.72|TWO_SIDED|95.0|-1.29|0.89|||Mixed Models Analysis|||Dairy||0.89|-1.29|0.72
73972048|NCT03952338|147484582|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.15|TWO_SIDED|95.0|-0.12|0.74|||Mixed Models Analysis|||Total protein||0.74|-0.12|0.15
73972049|NCT03952338|147484582|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.92|TWO_SIDED|95.0|-0.78|0.71|||Mixed Models Analysis|||Seafood and plant proteins||0.71|-0.78|0.92
73972050|NCT03952338|147484582|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.67|TWO_SIDED|95.0|-1.47|0.94|||Mixed Models Analysis|||Fatty acids||0.94|-1.47|0.67
73972051|NCT03952338|147484582|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.61|TWO_SIDED|95.0|-1.45|0.84|||Mixed Models Analysis|||Sodium||0.84|-1.45|0.61
73972052|NCT03952338|147484582|SUPERIORITY||Mean Difference (Final Values)|-1.15||||0.06|TWO_SIDED|95.0|-2.34|0.04|||Mixed Models Analysis|||Refined grains||0.04|-2.34|0.06
73972053|NCT03952338|147484582|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.32|TWO_SIDED|95.0|-0.51|1.57|||Mixed Models Analysis|||Saturated fats||1.57|-0.51|0.32
74030422|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|1.86||||0.001|TWO_SIDED|95.0|1.28|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Methods causing periods to stop are safe.||2.71|1.28|0.001
74091645|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|5.87|||||TWO_SIDED|95.0|2.88|11.94|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 16F||11.94|2.88|
73865503|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4797|TWO_SIDED|95.0|0.754|1.315|||Ratio of Active/Placebo|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.315|0.754|0.4797
73865504|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2659|TWO_SIDED|95.0|0.703|1.199|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.199|0.703|0.2659
73865505|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2102|TWO_SIDED|95.0|0.687|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.159|0.687|0.2102
73865506|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3623|TWO_SIDED|95.0|0.74|1.24|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.240|0.740|0.3623
73865507|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.3499|TWO_SIDED|95.0|0.73|1.225|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.225|0.730|0.3499
73865508|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6494|TWO_SIDED|95.0|0.787|1.377|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.377|0.787|0.6494
73865509|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5567|TWO_SIDED|95.0|0.766|1.358|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.358|0.766|0.5567
73865510|NCT01597635|147276857|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.1095|TWO_SIDED|95.0|0.615|1.073|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.073|0.615|0.1095
73865511|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6098|TWO_SIDED|95.0|0.721|1.644|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.644|0.721|0.6098
73865512|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.35||||0.9441|TWO_SIDED|95.0|0.931|2.068|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||2.068|0.931|0.9441
73865513|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.7173|TWO_SIDED|95.0|0.749|1.621|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.621|0.749|0.7173
73865514|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.8292|TWO_SIDED|95.0|0.81|1.949|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.949|0.810|0.8292
73865515|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.8008|TWO_SIDED|95.0|0.775|1.832|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.832|0.775|0.8008
73865516|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.2||||0.7905|TWO_SIDED|95.0|0.776|1.799|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.799|0.776|0.7905
73865517|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.7566|TWO_SIDED|95.0|0.737|1.958|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.958|0.737|0.7566
73865518|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.25||||0.8349|TWO_SIDED|95.0|0.812|2.05|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||2.050|0.812|0.8349
73865519|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4739|TWO_SIDED|95.0|0.713|1.527|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.527|0.713|0.4739
73972054|NCT03952338|147484582|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.63|TWO_SIDED|95.0|-0.56|0.92|||Mixed Models Analysis|||Added sugars||0.92|-0.56|0.63
73972055|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.85|TWO_SIDED|95.0|-0.61|0.5|||Mixed Models Analysis|||Total vegetables||0.50|-0.61|0.85
73972056|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.82|TWO_SIDED|95.0|-0.88|0.7|||Mixed Models Analysis|||Greens and beans||0.70|-0.88|0.82
73972057|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.48|TWO_SIDED|95.0|-0.43|0.93|||Mixed Models Analysis|||Total fruits||0.93|-0.43|0.48
73972058|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.06|TWO_SIDED|95.0|-0.04|1.46|||Mixed Models Analysis|||Whole fruits||1.46|-0.04|0.06
73972059|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.34|TWO_SIDED|95.0|-0.63|1.84|||Mixed Models Analysis|||Whole grains||1.84|-0.63|0.34
73972060|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.01|TWO_SIDED|95.0|0.31|2.62|||Mixed Models Analysis|||Dairy||2.62|0.31|0.01
73972061|NCT03952338|147484583|SUPERIORITY||Median Difference (Final Values)|0.21||||0.39|TWO_SIDED|95.0|-0.27|0.69|||Mixed Models Analysis|||Total protein||0.69|-0.27|0.39
73972062|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.81|TWO_SIDED|95.0|-0.9|0.7|||Mixed Models Analysis|||Seafood and plant proteins||0.70|-0.90|0.81
73972063|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.04|TWO_SIDED|95.0|-2.57|-0.04|||Mixed Models Analysis|||Fatty acids||-0.04|-2.57|0.04
73865520|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6291|TWO_SIDED|95.0|0.763|1.647|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.647|0.763|0.6291
73865521|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.18||||0.8032|TWO_SIDED|95.0|0.83|1.814|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.814|0.830|0.8032
73933781|NCT02443298|147397585|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.0131|TWO_SIDED|80.0|1.2|1.79|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.||1.79|1.20|0.0131
73933782|NCT02443298|147397586|SUPERIORITY||Rate Ratio|1.4937|STANDARD_ERROR_OF_MEAN|0.22||0.0065|TWO_SIDED|80.0|1.2366|1.8044|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.||1.8044|1.2366|0.0065
73933783|NCT02443298|147397587|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4619|TWO_SIDED|80.0|0.88|1.57|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|Time to first event is obtained from fitting a Cox proportional-hazards model including treatment, and OCS use at baseline as covariate||1.57|0.88|0.4619
73933784|NCT02443298|147397588|SUPERIORITY||Rate Ratio|1.1317|STANDARD_ERROR_OF_MEAN|0.237||0.555|TWO_SIDED|80.0|0.8652|1.4803|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.||1.4803|0.8652|0.5550
73933785|NCT02443298|147397589|SUPERIORITY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.051||0.4423|TWO_SIDED|80.0|-0.104|0.026|||Mixed Models Analysis|Unstructured covariance structure for within-patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.||0.026|-0.104|0.4423
73933786|NCT02443298|147397590|SUPERIORITY||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.045||0.1377|TWO_SIDED|80.0|-0.126|-0.009|||Mixed Models Analysis|Unstructured covariance structure for within-patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.||-0.009|-0.126|0.1377
73972064|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.25|TWO_SIDED|95.0|-1.86|0.48|||Mixed Models Analysis|||Sodium||0.48|-1.86|0.25
74030423|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|1.15||||0.36|TWO_SIDED|95.0|0.85|1.57||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - LARC can be removed early||1.57|0.85|0.36
74091646|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|13.76|||||TWO_SIDED|95.0|5.68|33.32|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23A||33.32|5.68|
73865522|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.325|TWO_SIDED|95.0|0.626|1.416|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.416|0.626|0.3250
73865523|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.5828|TWO_SIDED|95.0|0.687|1.63|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.630|0.687|0.5828
73865524|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4546|TWO_SIDED|95.0|0.661|1.512|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.512|0.661|0.4546
73865525|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6158|TWO_SIDED|95.0|0.719|1.639|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.639|0.719|0.6158
73933787|NCT02443298|147397591|SUPERIORITY||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.115||0.1985|TWO_SIDED|80.0|0.0|0.297|||ANCOVA||Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting an analysis of covariance (ANCOVA) model separately for each week including treatment, OCS use at baseline, and baseline as covariates. The weekly averages of daily measurements are calculated before fitting the model.||0.297|0.000|0.1985
73933788|NCT01591746|147397604|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
73933789|NCT01591746|147397605|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.56
73933790|NCT01591746|147397606|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Right breast initial percent volume expansion||||0.45
73933791|NCT01591746|147397606|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Left breast initial percent volume expansion||||0.98
73933792|NCT01591746|147397607|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
73933793|NCT01591746|147397608|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
73933794|NCT01591746|147397609|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
73933795|NCT00833924|147397644|SUPERIORITY_OR_OTHER||Rate of 30-day freedom from MAE|99.2|||<|0.01|TWO_SIDED|95.0|95.4|100.0|||Exact binomial test|||Null hypothesis: The 30-day Freedom from MAE for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (88%).||100|95.4|<0.01
73972065|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.91|TWO_SIDED|95.0|-1.25|1.4|||Mixed Models Analysis|||Refined grains||1.40|-1.25|0.91
73972066|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.89|TWO_SIDED|95.0|-0.98|1.13|||Mixed Models Analysis|||Saturated fats||1.13|-0.98|0.89
73972067|NCT03952338|147484583|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.59|TWO_SIDED|95.0|-0.55|0.97|||Mixed Models Analysis|||Added sugars||0.97|-0.55|0.59
73972068|NCT03952338|147484584|SUPERIORITY||Risk Ratio (RR)|0.15||||0.01|TWO_SIDED|95.0|0.03|0.67||Marginal food insecurity|Mixed Models Analysis|Mixed effects multinomial logistic regression||||0.67|0.03|0.01
73972069|NCT03952338|147484584|SUPERIORITY||Risk Ratio (RR)|0.56||||0.34|TWO_SIDED|95.0|0.17|1.82|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Moderate food insecurity||1.82|0.17|0.34
73972070|NCT03952338|147484584|SUPERIORITY||Risk Ratio (RR)|0.16||||0.02|TWO_SIDED|95.0|0.03|0.76|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Severe food insecurity||0.76|0.03|0.02
73972071|NCT03952338|147484585|SUPERIORITY||Risk Ratio, log|0.28||||0.1|TWO_SIDED|95.0|0.06|1.29|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Marginal food insecurity||1.29|0.06|0.10
73972072|NCT03952338|147484585|SUPERIORITY||Risk Ratio (RR)|0.68||||0.52|TWO_SIDED|95.0|0.21|2.21|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Moderate food insecurity||2.21|0.21|0.52
73972073|NCT03952338|147484585|SUPERIORITY||Risk Ratio (RR)|0.11||||0.01|TWO_SIDED|95.0|0.02|0.56|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Severe food insecurity||0.56|0.02|0.01
73972074|NCT03952338|147484586|SUPERIORITY||Risk Ratio (RR)|2.94||||0.15|TWO_SIDED|95.0|0.68|12.66|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Medium malnutrition risk||12.66|0.68|0.15
73972075|NCT03952338|147484586|SUPERIORITY||Risk Ratio (RR)|1.18||||0.86|TWO_SIDED|95.0|0.2|7.13|||Mixed Models Analysis|Mixed effects multinomial logistic regression||High malnutrition risk||7.13|0.20|0.86
73972076|NCT03952338|147484587|SUPERIORITY||Risk Ratio (RR)|1.28||||0.74|TWO_SIDED|95.0|0.31|5.38|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Medium malnutrition risk||5.38|0.31|0.74
73972077|NCT03952338|147484587|SUPERIORITY||Risk Ratio (RR)|5.48||||0.1|TWO_SIDED|95.0|0.73|41.3|||Mixed Models Analysis|Mixed effects multinomial logistic regression||High malnutrition risk||41.3|0.73|0.10
74088809|NCT03028740|147730642|SUPERIORITY||Percentage Difference|-3.2||||0.2067|TWO_SIDED|95.0|-8.2|1.9||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of Type 2 diabetes mellitus (T2DM) at Baseline).|Cochran-Mantel-Haenszel|||||1.9|-8.2|0.2067
73972078|NCT03952338|147484588|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.64|TWO_SIDED|95.0|-0.65|0.4|||Mixed Models Analysis|||||0.40|-0.65|0.64
73972079|NCT03952338|147484589|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.9|TWO_SIDED|95.0|-0.57|0.5|||Mixed Models Analysis|||||0.50|-0.57|0.90
73972080|NCT03952338|147484590|SUPERIORITY||Mean Difference (Final Values)|-4.07||||0.43|TWO_SIDED|95.0|-14.05|5.92||Males|Mixed Models Analysis|||||5.92|-14.05|0.43
73972081|NCT03952338|147484590|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.83|TWO_SIDED|95.0|-3.75|4.66|||Mixed Models Analysis|||Females||4.66|-3.75|0.83
73972082|NCT03952338|147484591|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.66|TWO_SIDED|95.0|-5.65|3.57||Age 18-59 years|Mixed Models Analysis|||||3.57|-5.65|0.66
73972083|NCT03952338|147484591|SUPERIORITY||Mean Difference (Final Values)|3.28||||0.4|TWO_SIDED|95.0|-4.36|10.93|||Mixed Models Analysis|||Age 60+ years||10.93|-4.36|0.40
73972084|NCT03952338|147484592|SUPERIORITY||Mean Difference (Final Values)|6.25||||0.43|TWO_SIDED|95.0|-9.13|21.63|||Mixed Models Analysis|||Males||21.63|-9.13|0.43
73865526|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.7748|TWO_SIDED|95.0|0.752|1.77|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.770|0.752|0.7748
73972085|NCT03952338|147484592|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.62|TWO_SIDED|95.0|-3.23|5.41|||Mixed Models Analysis|||Females||5.41|-3.23|0.62
73972086|NCT03952338|147484593|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.99|TWO_SIDED|95.0|-4.76|4.66|||Mixed Models Analysis|||18-59 years||4.66|-4.76|0.99
73972087|NCT03952338|147484593|SUPERIORITY||Mean Difference (Final Values)|3.66||||0.43|TWO_SIDED|95.0|-5.48|12.8|||Mixed Models Analysis|||60+ years||12.80|-5.48|0.43
73972088|NCT01928394|147484643|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0309|TWO_SIDED|95.0|1.06|4.26|||Cochran-Mantel-Haenszel|||SCLC Arm N Expansion as compare to SCLC Arm N-I Dose Level 2- Expansion||4.26|1.06|0.0309
73972089|NCT03386578|147484681|OTHER||Incidence rate ratio|1.62|||||TWO_SIDED|95.0|0.89|2.94||||||The incidence rate ratio of cumulative maternal adverse events was calculated between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and the PrEP-unexposed (Cohort 2/Step 1) reference group based on incidence per person-time follow-up. Maternal participants in Cohort 2/Step 2 contributed person-time to both Cohort 2/Step 1 and Step 2.||2.94|0.89|
73972090|NCT03386578|147484682|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.52|1.5||||||Odds ratio comparing the proportion of mothers with adverse pregnancy outcomes between the PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group.||1.50|0.52|
73972091|NCT03386578|147484682|OTHER|||||||0.68|||||||Fisher Exact|||Test the differences in the proportion of mothers with adverse pregnancy outcomes between PrEP-exposed (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 2) groups.||||0.68
73972092|NCT03386578|147484683|OTHER||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|0.7|2.38||||||The incidence rate ratio of cumulative infant AEs between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group was based on incidence per person-time follow-up. Cohort 2/Step 2 infants contributed person-time to both Cohort 2/Step 1 and Step 2.||2.38|0.70|
73972093|NCT03386578|147484684|OTHER|||||||0.18|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant whole-body bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.18
73972094|NCT03386578|147484685|OTHER|||||||0.39|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.39
73972095|NCT03386578|147484686|OTHER|||||||0.12|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.12
73972096|NCT03386578|147484687|OTHER|||||||0.7|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.70
73972097|NCT03386578|147484688|OTHER|||||||0.58|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.58
73865527|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.6565|TWO_SIDED|95.0|0.686|1.714|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.714|0.686|0.6565
73933796|NCT00833924|147397645|SUPERIORITY_OR_OTHER||12-month Device Success Rate|97.3|||<|0.01|TWO_SIDED|95.0|92.4|99.4|||Exact binomial test|||Null hypothesis: The 12-month device success for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (84%).||99.4|92.4|<0.01
73933797|NCT01385059|147397646|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73933798|NCT01767116|147397652|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|98.2|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%..|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.2|
73933799|NCT01767116|147397652|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.6|
73933800|NCT01767116|147397653|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%. The lower confidence bound of the 2-sided 95% CI for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|0.5|||||TWO_SIDED|95.0|-0.5|1.4|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a -10% margin, a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per arm provides \>95% power to demonstrate noninferiority of ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV compared with ABT-450/r/ABT-267 and ABT-333, plus RBV (normal approximation of a single binomial proportion in a 1-sample test for superiority).||1.4|-0.5|
73933801|NCT01767116|147397654|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73933802|NCT01767116|147397655|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|98.2|100.0|||||95% CI calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.2|
73933803|NCT01767116|147397655|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.6|100.0|||||95% CI calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.6|
73933804|NCT01975389|147397658|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.021469|TWO_SIDED|95.0|0.65|0.97|||Log Rank|||Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.97|0.65|0.021469
73933805|NCT01975389|147397659|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.007597|TWO_SIDED|95.0|0.6|0.93|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.93|0.60|0.007597
73933806|NCT01975389|147397660|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.035958|TWO_SIDED|95.0|0.68|0.99|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.99|0.68|0.035958
73933807|NCT01975389|147397661|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.015694|TWO_SIDED|95.0|0.64|0.95|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.95|0.64|0.015694
73865528|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.87||||0.2773|TWO_SIDED|95.0|0.566|1.38|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.380|0.566|0.2773
73865529|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.3606|TWO_SIDED|95.0|0.61|1.467|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.467|0.610|0.3606
73865530|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.83||||0.2211|TWO_SIDED|95.0|0.555|1.317|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.317|0.555|0.2211
73865531|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.286|TWO_SIDED|95.0|0.587|1.348|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.348|0.587|0.2860
73865532|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.4079|TWO_SIDED|95.0|0.609|1.51|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.510|0.609|0.4079
73865533|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5284|TWO_SIDED|95.0|0.614|1.663|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.663|0.614|0.5284
73865534|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.3586|TWO_SIDED|95.0|0.568|1.458|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.458|0.568|0.3586
73865535|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.6768|TWO_SIDED|95.0|0.672|1.853|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.853|0.672|0.6768
73972098|NCT03386578|147484689|OTHER|||||||0.08|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.08
73865536|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.77||||0.1574|TWO_SIDED|95.0|0.488|1.39|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.390|0.488|0.1574
73865537|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.39|TWO_SIDED|95.0|0.521|1.584|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.584|0.521|0.3900
73865538|NCT01597635|147276858|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.5915|TWO_SIDED|95.0|0.748|1.516|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.516|0.748|0.5915
73865539|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.06828|TWO_SIDED|95.0|0.528|1.501|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.501|0.528|0.06828
73865540|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.5674|TWO_SIDED|95.0|0.57|1.609|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.609|0.570|0.5674
73865541|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.66||||0.8855|TWO_SIDED|95.0|0.321|1.316|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.316|0.321|0.8855
73865542|NCT01597635|147276861|SUPERIORITY||Ratio of Active/Placebo|0.97||||0.5358|TWO_SIDED|95.0|0.531|1.76|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.760|0.531|0.5358
73865543|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.699|TWO_SIDED|95.0|0.622|2.155|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.155|0.622|0.6990
73865544|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.513|TWO_SIDED|95.0|0.549|1.721|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.721|0.549|0.5130
73865545|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.73||||0.7696|TWO_SIDED|95.0|0.3|1.731|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.731|0.300|0.7696
73865546|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.51||||0.9254|TWO_SIDED|95.0|0.203|1.289|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.289|0.203|0.9254
73972099|NCT03386578|147484690|OTHER|||||||0.52|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1)||||0.52
73865547|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.72||||0.7088|TWO_SIDED|95.0|0.216|2.419|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.419|0.216|0.7088
73865548|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.47||||0.8787|TWO_SIDED|95.0|0.112|1.69|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.690|0.112|0.8787
73865549|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.7338|TWO_SIDED|95.0|0.714|1.197|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.197|0.714|0.7338
73865550|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4955|TWO_SIDED|95.0|0.703|1.415|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.415|0.703|0.4955
73865551|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.5264|TWO_SIDED|95.0|0.541|1.788|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.788|0.541|0.5264
73865552|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.6183|TWO_SIDED|95.0|0.454|1.742|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.742|0.454|0.6183
73865553|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.03||||0.5291|TWO_SIDED|95.0|0.483|2.118|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.118|0.483|0.5291
73865554|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.74|TWO_SIDED|95.0|0.828|1.448|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.448|0.828|0.7400
73972100|NCT03386578|147484691|OTHER|||||||0.3|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.30
73865555|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.25||||0.9375|TWO_SIDED|95.0|0.937|1.683|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.683|0.937|0.9375
73972101|NCT03386578|147484692|OTHER|||||||0.06|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.06
73972102|NCT03386578|147484693|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73972103|NCT05907174|147484694|SUPERIORITY||B|-2.23||||0.023|TWO_SIDED||||||Regression, Linear|||||||0.023
73972104|NCT05093842|147484700|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73972105|NCT05093842|147484701|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73972106|NCT05093842|147484702|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73972107|NCT05093842|147484703|OTHER|Descriptive rates were calculated.|||||||||||||||||Descriptive statistics only|||
73972108|NCT05093842|147484704|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
73972109|NCT05093842|147484705|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
73865556|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.9118|TWO_SIDED|95.0|0.896|1.771|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.771|0.896|0.9118
73972110|NCT05093842|147484706|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
73972111|NCT02800356|147484841|OTHER|||||||0.404|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.404
73972112|NCT02800356|147484842|OTHER|||||||0.232|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.232
73972113|NCT02800356|147484843|OTHER|||||||0.001|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.001
73972114|NCT02800356|147484846|OTHER|||||||0.267|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.267
73972115|NCT05623228|147484862|SUPERIORITY|||||||0||||||"Bonferroni correction p\<.05~F(1.25)=9.17 η=.254 (p\<.05)"|ANOVA|||||||.00
73972116|NCT05623228|147484862|SUPERIORITY|||||||0||||||Bonferroni correction p\<.05 F(2)=7.30 η=.213 (P\<.05)|ANOVA|||||||.00
73972117|NCT05623228|147484863|SUPERIORITY|||||||0.04||||||F(2)=3.20, η=.106 Bonferroni Correction p\<.05|ANOVA|||||||.04
73865557|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.43||||0.9217|TWO_SIDED|95.0|0.866|2.382|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.382|0.866|0.9217
73865558|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.48||||0.8676|TWO_SIDED|95.0|0.73|3.064|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||3.064|0.730|0.8676
73972118|NCT05623228|147484864|SUPERIORITY|||||||0||||||F(1,06)=8,11, η2=.231 Bonferroni correction p\<.05|ANOVA|||||||.00
73972119|NCT05623228|147484865|SUPERIORITY|||||||0.04||||||F(1,19)=4,30, η2=.137 Bonferroni correction p\<0.5|ANOVA|||||||.04
73972120|NCT05623228|147484866|SUPERIORITY|||||||0||||||t (38.70)|t-test, 1 sided|||||||.00
73972121|NCT04625725|147484867|SUPERIORITY||Relative Risk Reduction|76.73|||<|0.001|TWO_SIDED|95.0|46.05|89.96|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|Primary Analysis||89.96|46.05|<0.001
73972122|NCT04625725|147484867|SUPERIORITY||Relative Risk Reduction|83.04|||<|0.001|TWO_SIDED|95.0|67.26|91.21|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|Final Analysis||91.21|67.26|<0.001
73972123|NCT04625725|147484869|SUPERIORITY||Relative Risk Reduction|34.9|||<|0.001|TWO_SIDED|95.0|21.44|46.05|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||46.05|21.44|<0.001
73972124|NCT04625725|147484870|SUPERIORITY||Relative Risk Reduction|91.41||||0.001|TWO_SIDED|95.0|61.31|98.09|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||98.09|61.31|0.001
73972125|NCT04625725|147484871|SUPERIORITY||Relative Risk Reduction|52.43||||0.137|TWO_SIDED|95.0|-26.61|82.13|||Poisson regression|||||82.13|-26.61|0.137
73972126|NCT05873556|147484900|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.97||||0.83|TWO_SIDED|95.0|0.74|1.27|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.27|0.74|0.83
73972127|NCT05873556|147484900|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.07||||0.61|TWO_SIDED|95.0|0.83|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.83|0.61
73972128|NCT05873556|147484901|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|1.16||||0.45|TWO_SIDED|95.0|0.79|1.72|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.72|0.79|0.45
74091647|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|19.28|||||TWO_SIDED|95.0|7.91|47.0|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23A||47.00|7.91|
73865559|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.83||||0.8835|TWO_SIDED|95.0|0.609|1.135|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.135|0.609|0.8835
73865560|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.5446|TWO_SIDED|95.0|0.723|1.33|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.330|0.723|0.5446
73865561|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.6267|TWO_SIDED|95.0|0.679|1.333|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.333|0.679|0.6267
73933808|NCT01975389|147397662|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.814224|TWO_SIDED|95.0|0.62|1.46|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.46|0.62|0.814224
73933809|NCT01975389|147397663|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.018053|TWO_SIDED|95.0|0.65|0.96|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.96|0.65|0.018053
73933810|NCT01975389|147397664|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.446033|TWO_SIDED|95.0|0.5|1.36|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.36|0.50|0.446033
73933811|NCT01975389|147397665|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.029977|TWO_SIDED|95.0|0.57|0.97|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.97|0.57|0.029977
73933812|NCT01975389|147397666|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.162615|TWO_SIDED|95.0|0.14|1.44|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.44|0.14|0.162615
73972129|NCT05873556|147484901|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.17||||0.46|TWO_SIDED|95.0|0.77|1.79|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.79|0.77|0.46
73865562|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.7668|TWO_SIDED|95.0|0.612|1.26|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.260|0.612|0.7668
73865563|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.61|TWO_SIDED|95.0|0.588|1.509|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.509|0.588|0.6100
73933813|NCT01975389|147397667|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.051534|TWO_SIDED|95.0|0.59|1.0|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.00|0.59|0.051534
73933814|NCT01975389|147397668|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104998|TWO_SIDED|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.09|0.41|0.104998
73933815|NCT01975389|147397669|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.294331|TWO_SIDED|95.0|0.5|1.24|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.24|0.50|0.294331
73933816|NCT01975389|147397671|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104998|TWO_SIDED|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.09|0.41|0.104998
73933817|NCT01975389|147397672|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6012|TWO_SIDED|95.0|0.6|1.34|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.34|0.60|0.601200
73933818|NCT01975389|147397673|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.678061|TWO_SIDED|95.0|0.72|1.67|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.67|0.72|0.678061
73865564|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.68||||0.8159|TWO_SIDED|95.0|0.291|1.623|||Bayesian repeated measures model|||Renin, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.623|0.291|0.8159
73865565|NCT01597635|147276861|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.53||||0.7988|TWO_SIDED|95.0|0.106|2.657|||Bayesian repeated measures model|||Aldosterone, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.657|0.106|0.7988
73933819|NCT01975389|147397674|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.010457|TWO_SIDED|95.0|0.63|0.94|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.94|0.63|0.010457
73933820|NCT01975389|147397675|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.509847|TWO_SIDED|95.0|0.71|2.01|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||2.01|0.71|0.509847
73933821|NCT01975389|147397676|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002981|TWO_SIDED|95.0|0.58|0.9|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.90|0.58|0.002981
73933822|NCT01975389|147397677|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.748975|TWO_SIDED|95.0|0.7|1.3|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.30|0.70|0.748975
73933823|NCT01975389|147397678|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.626157|TWO_SIDED|95.0|0.63|1.32|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.32|0.63|0.626157
73972130|NCT05873556|147484902|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.95||||0.62|TWO_SIDED|95.0|0.77|1.17|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.17|0.77|0.62
73972131|NCT05873556|147484902|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.14||||0.34|TWO_SIDED|95.0|0.87|1.48|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.48|0.87|0.34
73972132|NCT05873556|147484903|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|1.08||||0.66|TWO_SIDED|95.0|0.76|1.54|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.54|0.76|0.66
73972133|NCT05873556|147484903|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.02||||0.92|TWO_SIDED|95.0|0.75|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.75|0.92
74030424|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|2.76|||<|0.0001|TWO_SIDED|95.0|1.72|4.41||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - Copper IUD can act as EC||4.41|1.72|<0.0001
74030425|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|0.77||||0.49|TWO_SIDED|95.0|0.36|1.63||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - After sex, there is something you can do to prevent pregnancy||1.63|0.36|0.49
73865566|NCT01597635|147276862|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.6536|TWO_SIDED|95.0|0.626|2.024|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||2.024|0.626|0.6536
73933824|NCT01975389|147397679|SUPERIORITY||LS mean difference|-56.9|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-57.91|-55.89|||MMRM|||Least square (LS) mean differences, associated 95% CI, and p-values were from an mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-55.89|-57.91|<0.001
73933825|NCT01975389|147397680|SUPERIORITY||LS mean difference|-73.8|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-75.11|-72.5|||MMRM|||LS mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-72.50|-75.11|<0.001
73933826|NCT01975389|147397681|SUPERIORITY||LS mean difference|-39.31|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-40.55|-38.06|||ANCOVA|||LS-mean difference, associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and complete statin intolerance.||-38.06|-40.55|<0.001
73933827|NCT01975389|147397682|SUPERIORITY||LS mean difference|-51.87|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-52.81|-50.94|||MMRM|||Non-HDLC: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-50.94|-52.81|<0.001
73933828|NCT01975389|147397682|SUPERIORITY||LS mean difference|-18.41|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-19.96|-16.86|||MMRM|||VLDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-16.86|-19.96|<0.001
73933829|NCT01975389|147397682|SUPERIORITY||LS mean difference|-29.2|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|-31.44|-26.96|||MMRM|||RLP-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-26.96|-31.44|<0.001
73933830|NCT01975389|147397682|SUPERIORITY||LS mean difference|-51.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-52.37|-50.42|||MMRM|||Apo B: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-50.42|-52.37|<0.001
73972134|NCT04484428|147484921|SUPERIORITY|||||||0.773|||||||ANCOVA|||||||0.773
73972135|NCT04484428|147484922|SUPERIORITY|||||||0.972|||||||ANCOVA|||||||0.972
73972136|NCT04484428|147484923|SUPERIORITY|||||||0.617|||||||ANCOVA|||||||0.617
73972137|NCT04484428|147484924|SUPERIORITY|||||||0.796|||||||ANCOVA|||||||0.796
73972138|NCT04484428|147484925|SUPERIORITY|||||||0.96|||||||ANCOVA|||||||0.960
73972139|NCT04484428|147484926|SUPERIORITY|||||||0.761|||||||ANCOVA|||||||0.761
73865567|NCT01597635|147276862|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.3||||0.9066|TWO_SIDED|95.0|0.876|1.955|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.955|0.876|0.9066
73972140|NCT04484428|147484927|SUPERIORITY|||||||0.979|||||||ANCOVA|||||||0.979
73972141|NCT04484428|147484928|SUPERIORITY|||||||0.803|||||||ANCOVA|||||||0.803
73972142|NCT03825588|147484947|SUPERIORITY|||||||0.71||||||False Discovery Rate q-value \> 0.99|Chi-squared|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of actual suicide attempts||||0.71
73972143|NCT03825588|147484947|SUPERIORITY|||||||0.43||||||False Discovery Rate q-vale \> 0.99|Chi-squared|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of actual suicide attempts||||0.43
73972144|NCT03825588|147484947|SUPERIORITY||Odds Ratio (OR)|0.4||||0.21|TWO_SIDED|95.0|0.1|1.66||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Interaction effect of ASAP and BRITE.||1.66|0.10|0.21
73972145|NCT03825588|147484947|SUPERIORITY||Odds Ratio (OR)|1.31||||0.57|TWO_SIDED|95.0|0.51|3.34||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of ASAP||3.34|0.51|0.57
73972146|NCT03825588|147484947|SUPERIORITY||Odds Ratio (OR)|1.15||||0.77|TWO_SIDED|95.0|0.44|2.97||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of BRITE.||2.97|0.44|0.77
73865568|NCT01597635|147276862|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.7859|TWO_SIDED|95.0|0.723|2.066|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||2.066|0.723|0.7859
73865569|NCT01597635|147276862|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.6058|TWO_SIDED|95.0|0.413|1.963|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.963|0.413|0.6058
73865570|NCT01597635|147276862|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.29||||0.6921|TWO_SIDED|95.0|0.456|3.632|||Ratio of Active/Placebo|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||3.632|0.456|0.6921
73972147|NCT03825588|147484947|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.74|TWO_SIDED|95.0|0.48|1.69||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on time to actual suicide attempt||1.69|0.48|0.74
73972148|NCT03825588|147484947|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.45|TWO_SIDED|95.0|0.42|1.48||False Discovery Rate q-vale \> 0.99|Regression, Cox|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the time to actual suicide attempt||1.48|0.42|0.45
73972149|NCT03825588|147484947|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.25|TWO_SIDED|95.0|0.13|1.72||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Interaction effect of ASAP and BRITE||1.72|0.13|0.25
73972150|NCT03825588|147484947|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.62|TWO_SIDED|95.0|0.54|2.87||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.||2.87|0.54|0.62
73972151|NCT03825588|147484947|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.83|TWO_SIDED|95.0|0.47|2.59||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.||2.59|0.47|0.83
73972152|NCT03825588|147484948|SUPERIORITY|||||||0.19||||||False Discovery Rate q-value = 0.72|Chi-squared|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of suicidal events|We used standard univariate statistics to compare partici- pants' baseline sociodemographics and clinical characteris- tics by arm \[(ASAP vs No ASAP where comparison is 6 www.jaacap.org (ASAP+TAU) and (ASAP+BRITE+TAU) vs (TAU alone) and (BRITE+TAU); and BRITE vs No BRITE where comparison is (ASAP+BRITE+TAU) and (BRITE+TAU) vs (ASAP+TAU) and (TAU Alone)\], site, retention, pre- post-COVID and recruitment venue. We then tested for equality of the 2 cells (ASAP vs no ASAP, BRITE vs no BRITE) or 4 cells (ASAP+BRITE+TAU vs BRITE +TAU vs ASAP+TAU vs TAU Alone) without covariates on the rates of and time to suicidal behavior using the appropriate (t or F, c2, Kaplan-Meier, Cox models) test statistics. We then used mixed-effects regression models with arm (2 and 4 cells), time, and their interaction for continuous data. Presented percentages are based on all observed data.|||0.19
73865571|NCT01597635|147276863|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.7934|TWO_SIDED|95.0|0.737|1.14|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.140|0.737|0.7934
73972153|NCT03825588|147484948|SUPERIORITY|||||||0.89|TWO_SIDED|95.0||||False Discovery Rate q-value \> 0.99|Chi-squared|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of suicidal events||||0.89
73972154|NCT03825588|147484948|SUPERIORITY||Odds Ratio (OR)|0.35||||0.08|TWO_SIDED|95.0|0.11|1.1||False Discovery Rate q-value = 0.72|Regression, Logistic|||Compare participants the 4 arms on the rate of suicidal events in a 2x2 factorial design. Interaction effect of ASAP and BRITE.||1.10|0.11|0.08
73972155|NCT03825588|147484948|SUPERIORITY||Odds Ratio (OR)|1.14||||0.74|TWO_SIDED|95.0|0.51|2.55||False Discovery Rate q \> 0.99|Regression, Logistic|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.||2.55|0.51|0.74
73972156|NCT03825588|147484948|SUPERIORITY||Odds Ratio (OR)|1.69||||0.19|TWO_SIDED|95.0|0.77|3.69||False Discovery Rate q=0.72|Regression, Logistic|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.||3.69|0.77|0.19
73972157|NCT04228042|147484959|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
73972158|NCT04228042|147484959|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
73972159|NCT04228042|147484959|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73972160|NCT04228042|147484959|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73972161|NCT05452460|147485008|SUPERIORITY||Mean Difference (Final Values)|0.11|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in RT as the outcome, with Group as the factor, and pre-test condition difference in RT as the covariate.||||||> 0.05
73865572|NCT01597635|147276863|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5205|TWO_SIDED|95.0|0.782|1.317|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.317|0.782|0.5205
73865573|NCT01597635|147276863|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.6682|TWO_SIDED|95.0|0.673|1.865|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.865|0.673|0.6682
73865574|NCT01597635|147276863|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.5304|TWO_SIDED|95.0|0.744|1.315|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.315|0.744|0.5304
73865575|NCT01597635|147276863|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.81||||0.9078|TWO_SIDED|95.0|0.582|1.112|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.112|0.582|0.9078
73865576|NCT01597635|147276863|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.9907|TWO_SIDED|95.0|1.042|1.526|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.526|1.042|0.9907
73865577|NCT01597635|147276863|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.27||||0.9973|TWO_SIDED|95.0|1.005|1.606|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.606|1.005|0.9973
73865578|NCT01597635|147276863|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.61||||0.9954|TWO_SIDED|95.0|1.13|2.331|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||2.331|1.130|0.9954
73865579|NCT01597635|147276863|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.65||||0.983|TWO_SIDED|95.0|1.045|2.588|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.588|1.045|0.9830
73865580|NCT01597635|147276863|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.52||||0.9312|TWO_SIDED|95.0|0.867|2.737|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.737|0.867|0.9312
73865581|NCT03464019|147276877|SUPERIORITY||Hazard Ratio (HR)|1.086||||0.1212|TWO_SIDED|95.0|0.726|1.623|||Peto-Peto test|||In Part 1, participants who converted following medical assistance were censored at the time of conversion after medical assistance. Participants who presented missing data from time t to the end were censored at the time of last available data. Participants who did not convert or were not censored before 5 hours were censored at 5 hours.||1.623|0.726|0.1212
73865582|NCT03464019|147276877|SUPERIORITY||Hazard Ratio (HR)|2.857|||<|0.001|TWO_SIDED|95.0|1.868|4.371||The threshold for statistical significance was p \< 0.05.|Wilcoxon|||In Parts 2 and 3, participants converting after additional medication interventions were censored after the end of the observation period.||4.371|1.868|<0.001
73865583|NCT00126776|147276883|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||mean cumulative frequency|||primary outcome is mean cumulative frequency of COPD related hospitlaizations and ED visits ;ver 1 yr: 0.48 for disease management; 0.82 for usual care, difference 0.34 (95% CI 0.15 to 0.52; P\<0.001)||||< 0.001
73865584|NCT02893917|147276888|SUPERIORITY||Hazard Ratio (HR)|0.617||||0.0359|TWO_SIDED|95.0|0.392|0.969|||Regression, Cox|||||0.969|0.392|0.0359
73865585|NCT02893917|147276889|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.705|2.399||no p value provided|Regression, Cox|||||2.399|0.705|
73865586|NCT02893917|147276892|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.272|1.504|||Regression, Cox|||HRD positive ONLY||1.504|0.272|
73865587|NCT02893917|147276892|OTHER||Hazard Ratio (HR)|0.777|||||TWO_SIDED|95.0|0.448|1.348|||Regression, Cox|||HRD negative ONLY||1.348|0.448|
73865588|NCT03626545|147276898|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.633|TWO_SIDED|95.0|0.76|1.48|||Log Rank||Hazard ratio was estimated using a Cox Proportional Hazards regression model stratified by line of therapy and histology|||1.48|0.76|0.633
73865589|NCT01939366|147276926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.37||0.0621|TWO_SIDED|95.0|-1.43|0.04||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||0.04|-1.43|0.0621
73933831|NCT01975389|147397682|SUPERIORITY||LS mean difference|6.91|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|6.33|7.5|||MMRM|||HDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||7.50|6.33|<0.001
73933832|NCT01975389|147397682|SUPERIORITY||LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|3.9|4.9|||MMRM|||Apo A-I: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||4.90|3.90|<0.001
73933833|NCT01975389|147397682|SUPERIORITY||LS mean difference|-37.99|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-38.75|-37.22|||MMRM|||Total cholesterol: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-37.22|-38.75|<0.001
73972162|NCT05452460|147485009|SUPERIORITY||Mean Difference (Final Values)|0.18|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in ACC the outcome, with Group as the factor, and pre-test condition difference in ACC as the covariate.||||||> .05
73972163|NCT05452460|147485010|SUPERIORITY||Mean Difference (Final Values)|0.32|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in N2 the outcome, with Group as the factor, and pre-test condition difference in N2 as the covariate.||||||> 0.05
73972164|NCT05452460|147485011|SUPERIORITY||Mean Difference (Final Values)|0.71|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in P3 the outcome, with Group as the factor, and pre-test condition difference in P3 as the covariate.||||||> 0.05
73933834|NCT01975389|147397683|SUPERIORITY||LS mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.81|0.83|||MMRM|||Triglycerides: LS-mean differences, associated 95% CI and p-values were from an MMRM model including observations through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.||0.83|0.81|<0.001
73933835|NCT01975389|147397683|SUPERIORITY||LS mean difference|0.68|||<|0.001|TWO_SIDED|95.0|0.67|0.69|||MMRM|||Lp(a): LS-mean differences, associated 95% CI and p-values were from an MMRM model on the Difference of log-transformed observations with fixed effects for treatment group, visit, a treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.||0.69|0.67|<0.001
73933836|NCT01975389|147397684|SUPERIORITY||LS mean difference|1.06||||0.002|TWO_SIDED|95.0|1.02|1.09|||MMRM|||LS-mean differences, associated 95% CI and p-values were from an MMRM model on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance.||1.09|1.02|0.002
73933837|NCT03299192|147397685|SUPERIORITY|||||||0.001||||||This feasibility study is small and not designed to look at outcome statistics|GEE with Ancova features|||||||.001
73933838|NCT03735862|147397701|OTHER|Paired t-Test|||||<|0.001|||||||t-test, 1 sided|||Difference between baseline and follow-up||||<0.001
73933839|NCT03735862|147397702|SUPERIORITY||||||<|0.0001|||||||McNemar|||Difference between baseline and follow-up||||<0.0001
73933840|NCT04122443|147397714|SUPERIORITY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.3|1.9||||||||1.9|0.3|
73933841|NCT04122443|147397715|SUPERIORITY||Mean Difference (Final Values)|13.0|||||TWO_SIDED|95.0|-3.0|29.0||||||||29|-3|
73933842|NCT04122443|147397716|SUPERIORITY||Mean Difference (Final Values)|9.0|||||TWO_SIDED|95.0|-5.0|23.0||||||||23|-5|
73933843|NCT04122443|147397717|SUPERIORITY||Mean Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-10.0|21.0||||||||21|-10|
73933844|NCT01306617|147397737|SUPERIORITY_OR_OTHER|||||||0.547|TWO_SIDED||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||For the percentage of subjects with HCV RNA suppressed below the LLOD from Week 4 through Week 12, if it was assumed that 60% of subjects would be successfully suppressed from Week 4 through Week 12, then 20 subjects in arm 1 would give a 95% 2-sided confidence interval (CI) of (38.5%, 81.5%), 10 subjects in arm 2 would give a 95% CI of (29.6%, 90.4%), and 15 subjects in arm 3 would give a 95% CI of (35.2%, 84.8%) for the percentage of subjects suppressed using the binomial exact method.||||0.547
73933845|NCT01306617|147397737|SUPERIORITY_OR_OTHER|||||||0.207|TWO_SIDED||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.207
73933846|NCT01306617|147397738|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.061
73933847|NCT01306617|147397739|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.061
73933848|NCT01306617|147397739|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.375
73933849|NCT01306617|147397740|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.312
73933850|NCT01306617|147397740|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.012
73933851|NCT01306617|147397741|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.312
73933852|NCT01306617|147397741|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.012
73933853|NCT01306617|147397742|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||Log Rank|||||||0.395
73933854|NCT01306617|147397742|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Log Rank|||||||0.010
73933855|NCT01306617|147397743|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Log Rank|||||||0.048
73933856|NCT01130740|147397749|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED||||||Mixed Models Analysis|||This is a comparison of 6-month outcomes between the two study groups. (Primary comparison is for 12 months.)||||0.158
73933857|NCT01130740|147397749|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Mixed Models Analysis|||This is the 12-month comparison between the 2 study groups, which is the primary study analysis.||||0.008
73933858|NCT01130740|147397750|SUPERIORITY_OR_OTHER|||||||0.274|TWO_SIDED||||||Mixed Models Analysis|||This is the between-group 12-month comparison.||||0.274
73933859|NCT01130740|147397751|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||Mixed Models Analysis|||||||0.177
73933860|NCT04028388|147397756|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.1465|TWO_SIDED|95.0|0.56|2.65|||Wilcoxon (Mann-Whitney)|||||2.65|0.56|0.1465
73933861|NCT04028388|147397760|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.4576|TWO_SIDED|95.0|0.39|7.93|||Log Rank|||DOR is calculated in the subpopulation of subjects experiencing a response (CR or PR). Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome.||7.93|0.39|0.4576
73933862|NCT04028388|147397761|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.0776|TWO_SIDED|95.0|0.65|3.48|||Wilcoxon (Mann-Whitney)|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome"||3.48|0.65|0.0776
73933863|NCT04028388|147397763|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.2539|TWO_SIDED|95.0|0.79|2.49|||Log Rank|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome."||2.49|0.79|0.2539
73933864|NCT04028388|147397764|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.3062|TWO_SIDED|95.0|0.76|2.42|||Wilcoxon (Mann-Whitney)|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome."||2.42|0.76|0.3062
73933865|NCT02939105|147397779|OTHER||success proportion|86.7|||||TWO_SIDED|95.0|69.3|96.2||||||||96.2|69.3|
73933866|NCT01940705|147397781|SUPERIORITY||Mean Difference (Final Values)|5.578||||0.001|TWO_SIDED||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Skills scale||||0.001
73933867|NCT01940705|147397781|SUPERIORITY||Mean Difference (Final Values)|4.235||||0.003|TWO_SIDED||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Knowledge scale||||0.003
73933868|NCT01940705|147397782|SUPERIORITY||Mean Difference (Final Values)|0.956||||0.414|TWO_SIDED||||||ANOVA|||||||0.414
73933869|NCT01940705|147397783|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.847|TWO_SIDED||||||ANOVA|||||||0.847
73933870|NCT00139997|147397784|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|||||||0.028
73933871|NCT03779841|147397793|SUPERIORITY||Risk Ratio (RR)|0.8||||0.1612|TWO_SIDED|95.0|0.58|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.58|0.1612
73972165|NCT05452460|147485012|SUPERIORITY||Mean Difference (Final Values)|13.35|||<|0.01|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in TTE the outcome, with Group as the factor, and pre-test condition difference in TTE as the covariate.|\[F(1, 52) = 13.35, p = .001, ηp2 = .211\]|||||< 0.01
73933872|NCT03779841|147397793|SUPERIORITY||Risk Ratio (RR)|1.04||||0.7789|TWO_SIDED|95.0|0.79|1.37|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.37|0.79|0.7789
73933873|NCT03779841|147397794|SUPERIORITY|||||||0.2972|||||||stratified Wilcoxon (Van Elteren)|||P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.2972
73933874|NCT03779841|147397794|SUPERIORITY|||||||0.8722|||||||stratified Wilcoxon (Van Elteren)|||P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.8722
73933875|NCT03779841|147397795|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9814|TWO_SIDED|95.0|0.5|1.96|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.96|0.50|0.9814
73933876|NCT03779841|147397795|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9715|TWO_SIDED|95.0|0.5|1.97|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.97|0.50|0.9715
73933877|NCT03779841|147397796|SUPERIORITY|||||||0.1281|||||||Log Rank|||P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.1281
73933878|NCT03779841|147397796|SUPERIORITY|||||||0.882|||||||Log Rank|||P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.8820
73933879|NCT03779841|147397797|SUPERIORITY||Risk Ratio (RR)|0.79||||0.1623|TWO_SIDED|95.0|0.57|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.57|0.1623
73933880|NCT03779841|147397797|SUPERIORITY||Risk Ratio (RR)|1.04||||0.7776|TWO_SIDED|95.0|0.78|1.39|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.39|0.78|0.7776
73933881|NCT03779841|147397798|SUPERIORITY||Risk Ratio (RR)|0.79||||0.1603|TWO_SIDED|95.0|0.56|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.56|0.1603
73933882|NCT03779841|147397798|SUPERIORITY||Risk Ratio (RR)|1.06||||0.6706|TWO_SIDED|95.0|0.8|1.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.42|0.80|0.6706
73972166|NCT05452460|147485013|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in VO2max Covariate: Pre-test condition difference in VO2max||||||> 0.05
73972167|NCT05452460|147485014|SUPERIORITY||Mean Difference (Final Values)|38.76|||<|0.01|TWO_SIDED||||||ANOVA|Four-way mixed-design ANOVA: 2 (GROUP) × 2 (CONDITION) × 3 (ASSESSMENT TIME) × 2 (Experiment Phase)||||||< 0.01
73972168|NCT05452460|147485015|SUPERIORITY||Mean Difference (Final Values)|9.21|||<|0.01|TWO_SIDED|||||The main effect of the Stroop block on accuracy showed a decrease from the first block to the fifth block.|ANOVA|Four-way mixed-design ANOVA: 2 (GROUP) × 2 (CONDITION) × 5 (BLOCK) × 2 (Phase)||||||< 0.01
73972169|NCT05452460|147485016|SUPERIORITY||Mean Difference (Final Values)|7.07|||<|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test mean score Covariate: Pre-test mean score||||||< 0.05
73933883|NCT03779841|147397799|SUPERIORITY||Risk Ratio (RR)|0.78||||0.1583|TWO_SIDED|95.0|0.55|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.55|0.1583
73933884|NCT03779841|147397799|SUPERIORITY||Risk Ratio (RR)|1.07||||0.6694|TWO_SIDED|95.0|0.8|1.43|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.43|0.80|0.6694
73933885|NCT03779841|147397800|SUPERIORITY||Risk Ratio (RR)|0.81||||0.2578|TWO_SIDED|95.0|0.55|1.18|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.18|0.55|0.2578
73933886|NCT03779841|147397800|SUPERIORITY||Risk Ratio (RR)|1.05||||0.7526|TWO_SIDED|95.0|0.76|1.47|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.47|0.76|0.7526
73933887|NCT03779841|147397801|SUPERIORITY||Risk Ratio (RR)|0.8||||0.2549|TWO_SIDED|95.0|0.55|1.18|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.18|0.55|0.2549
73933888|NCT03779841|147397801|SUPERIORITY||Risk Ratio (RR)|1.03||||0.8544|TWO_SIDED|95.0|0.73|1.45|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.45|0.73|0.8544
73933889|NCT03779841|147397802|SUPERIORITY||Risk Ratio (RR)|0.74||||0.1718|TWO_SIDED|95.0|0.48|1.14|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.14|0.48|0.1718
73933890|NCT03779841|147397802|SUPERIORITY||Risk Ratio (RR)|0.83||||0.3801|TWO_SIDED|95.0|0.54|1.27|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.27|0.54|0.3801
73933891|NCT03779841|147397803|SUPERIORITY||Risk Ratio (RR)|0.87||||0.5531|TWO_SIDED|95.0|0.54|1.39|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.39|0.54|0.5531
73972170|NCT05452460|147485017|SUPERIORITY||Mean Difference (Final Values)|1.37|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed anger Covariate: Pre-test condition difference in changed anger||||||> 0.05
73933892|NCT03779841|147397803|SUPERIORITY||Risk Ratio (RR)|0.82||||0.4213|TWO_SIDED|95.0|0.51|1.33|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.33|0.51|0.4213
73933893|NCT03779841|147397804|SUPERIORITY||Risk Ratio (RR)|0.92||||0.804|TWO_SIDED|95.0|0.49|1.73|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.73|0.49|0.8040
73933894|NCT03779841|147397804|SUPERIORITY||Risk Ratio (RR)|1.1||||0.7573|TWO_SIDED|95.0|0.61|1.98|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.98|0.61|0.7573
73933895|NCT03779841|147397805|SUPERIORITY||Risk Ratio (RR)|0.69||||0.4065|TWO_SIDED|95.0|0.28|1.67|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.67|0.28|0.4065
73933896|NCT03779841|147397805|SUPERIORITY||Risk Ratio (RR)|1.28||||0.5257|TWO_SIDED|95.0|0.6|2.7|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||2.70|0.60|0.5257
73933897|NCT03779841|147397806|SUPERIORITY||Risk Ratio (RR)|0.78||||0.1612|TWO_SIDED|95.0|0.55|1.11|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.11|0.55|0.1612
73972171|NCT05452460|147485018|SUPERIORITY||Mean Difference (Final Values)|2.73|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
73972172|NCT05452460|147485019|SUPERIORITY||Mean Difference (Final Values)|0.07|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed depression Covariate: Pre-test condition difference in changed depression||||||> 0.05
73972173|NCT05452460|147485020|SUPERIORITY||Mean Difference (Final Values)|0.2|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed fatigue Covariate: Pre-test condition difference in changed fatigue||||||> 0.05
73933898|NCT03779841|147397806|SUPERIORITY||Risk Ratio (RR)|1.0||||0.9966|TWO_SIDED|95.0|0.74|1.35|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.35|0.74|0.9966
73933899|NCT03779841|147397807|SUPERIORITY||Risk Ratio (RR)|0.68||||0.3374|TWO_SIDED|95.0|0.3|1.52|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.52|0.30|0.3374
73933900|NCT03779841|147397807|SUPERIORITY||Risk Ratio (RR)|1.23||||0.5403|TWO_SIDED|95.0|0.62|2.45|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||2.45|0.62|0.5403
73933901|NCT03779841|147397808|SUPERIORITY||Risk Ratio (RR)|3.94||||0.0163|TWO_SIDED|95.0|1.16|13.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||13.42|1.16|0.0163
73933902|NCT03779841|147397808|SUPERIORITY||Risk Ratio (RR)|2.7||||0.1101|TWO_SIDED|95.0|0.76|9.64|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||9.64|0.76|0.1101
73933903|NCT03779841|147397809|SUPERIORITY||Risk Ratio (RR)|0.86||||0.3339|TWO_SIDED|95.0|0.64|1.16|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.16|0.64|0.3339
73933904|NCT03779841|147397809|SUPERIORITY||Risk Ratio (RR)|1.1||||0.4614|TWO_SIDED|95.0|0.85|1.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.42|0.85|0.4614
73933905|NCT03483623|147397838|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
73933906|NCT03483623|147397839|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
73933907|NCT03483623|147397840|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
73933908|NCT03483623|147397841|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
73933909|NCT03483623|147397842|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
73933910|NCT03483623|147397843|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
73933911|NCT03483623|147397844|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
73933912|NCT03483623|147397845|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
73933913|NCT01612546|147397855|OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
73972174|NCT05452460|147485021|SUPERIORITY||Mean Difference (Final Values)|0.01|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
73933914|NCT02276495|147397865|SUPERIORITY|||||||0.668|||||||Kruskal-Wallis|||||||0.668
73933915|NCT02276495|147397866|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
73933916|NCT02276495|147397867|SUPERIORITY|||||||0.013|||||||Kruskal-Wallis|||||||0.013
73933917|NCT00612313|147397873|SUPERIORITY_OR_OTHER||Difference in percentages|9.7||||0.02|TWO_SIDED|||||The estimated rate of time spent well was evaluated using a Poisson regression with adjustment for CDRS-R score at the end of the acute phase, age group, and gender.|Regression, Poisson||Differencein percentages represents estimated percentage for medication management + CBT Arm minus estimated percentage for medication management only Arm.|||||.02
73933918|NCT01016834|147397877|SUPERIORITY_OR_OTHER|||||||0.0007|||||||t-test, 2 sided|||For the primary analyses and other PPMQ-R variables, the mean of the differences between each subject's rating of overall treatment satisfaction at the end of study based on the subject's experience using Sumavel DosePro and the rating at baseline based on the subject's pre-study triptan treatment were compared using a two-sided paired t-test at the 5% level of significance||||0.0007
73972175|NCT05452460|147485022|SUPERIORITY||Mean Difference (Final Values)|0.66|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
73972176|NCT04447040|147485034|SUPERIORITY||Least square (LS) Mean Difference|31.48|STANDARD_ERROR_OF_MEAN|5.379|<|0.001|TWO_SIDED|95.0|20.9|42.07|||ANOVA|||||42.07|20.90|<0.001
73972177|NCT04447040|147485034|SUPERIORITY||LS Mean Difference|41.38|STANDARD_ERROR_OF_MEAN|5.267|<|0.001|TWO_SIDED|95.0|31.02|51.75|||ANOVA|||||51.75|31.02|<0.001
73972178|NCT04447040|147485034|SUPERIORITY||LS Mean Difference|46.86|STANDARD_ERROR_OF_MEAN|5.292|<|0.001|TWO_SIDED|95.0|36.44|57.27|||ANOVA|||||57.27|36.44|<0.001
73933919|NCT03403634|147397897|SUPERIORITY|||||||0.046||||||significance level = 0.05|t-test, 1 sided|df = 11. one-sided as post treatment increases were of interest. the fold changes were log-transformed prior to inferences.||||||0.046
73933920|NCT01627249|147397907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||<|0.001|TWO_SIDED|95.0|1.4|5.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab||5.7|1.4|<0.001
73933921|NCT01627249|147397907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1||||0.034|TWO_SIDED|95.0|0.1|4.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab||4.2|0.1|0.034
73933922|NCT01627249|147397907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.12|TWO_SIDED|95.0|-0.4|3.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs. Bevacizumab||3.2|-0.4|0.12
73933923|NCT01627249|147397908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-69.9|||<|0.001|TWO_SIDED|95.0|-91.1|-48.6|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab||-48.6|-91.1|<0.001
73933924|NCT01627249|147397908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.6||||0.036|TWO_SIDED|95.0|-36.0|-1.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab||-1.2|-36|0.036
73933925|NCT01627249|147397908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-51.2|||<|0.001|TWO_SIDED|95.0|-71.2|-31.3|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||-31.3|-71.2|<0.001
73972179|NCT04447040|147485034|SUPERIORITY||LS Mean Difference|54.04|STANDARD_ERROR_OF_MEAN|5.321|<|0.001|TWO_SIDED|95.0|43.57|64.51|||ANOVA|||||64.51|43.57|<0.001
73972180|NCT04447040|147485034|SUPERIORITY||LS Mean Difference|59.92|STANDARD_ERROR_OF_MEAN|5.468|<|0.001|TWO_SIDED|95.0|49.16|70.68|||ANOVA|||||70.68|49.16|<0.001
73933926|NCT01627249|147397909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5||||0.001|TWO_SIDED|95.0|2.9|10.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab||10.1|2.9|0.001
74088810|NCT03028740|147730642|SUPERIORITY||Odds Ratio (OR)|0.8369|||||TWO_SIDED|95.0|0.6341|1.1044|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.1044|0.6341|
73933927|NCT01627249|147397909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7||||0.0031|TWO_SIDED|95.0|1.4|8.0|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab||8.0|1.4|0.0031
73933928|NCT01627249|147397909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.21|TWO_SIDED|95.0|-1.1|4.8|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||4.8|-1.1|0.21
73933929|NCT01627249|147397910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.69|TWO_SIDED|95.0|-1.3|2.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab||2.7|-1.3|0.69
73933930|NCT01627249|147397910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED|95.0|-2.3|1.5|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab||1.5|-2.3|0.69
73933931|NCT01627249|147397910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.69|TWO_SIDED|95.0|-0.9|3.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||3.1|-0.9|0.69
73933932|NCT02039505|147397934|SUPERIORITY||Adjusted Odds Ratio|1.37||||0.2722|TWO_SIDED|95.0|0.779|2.399|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||2.399|0.779|0.2722
73933933|NCT02039505|147397935|SUPERIORITY||Adjusted Odds Ratio|2.88||||0.021|TWO_SIDED|95.0|1.168|7.108|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||7.108|1.168|0.0210
73933934|NCT02039505|147397941|SUPERIORITY||Adjusted Odds Ratio|1.66||||0.198|TWO_SIDED|95.0|0.762|3.596|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||3.596|0.762|0.1980
73933935|NCT02039505|147397942|SUPERIORITY||Adjusted Odds Ratio|1.33||||0.3168|TWO_SIDED|95.0|0.755|2.356|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||2.356|0.755|0.3168
73933936|NCT02039505|147397943|SUPERIORITY||Adjusted Odds Ratio|3.48||||0.0067|TWO_SIDED|95.0|1.407|8.626|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||8.626|1.407|0.0067
73933937|NCT02039505|147397944|SUPERIORITY||Adjusted Odds Ratio|3.49||||0.0066|TWO_SIDED|95.0|1.409|8.642|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||8.642|1.409|0.0066
73933938|NCT02039505|147397945|SUPERIORITY||Adjusted Odds Ratio|2.02||||0.209|TWO_SIDED|95.0|0.677|6.033|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||6.033|0.677|0.2090
73933939|NCT02039505|147397946|SUPERIORITY||Adjusted Odds Ratio|3.38||||0.1571|TWO_SIDED|95.0|0.636|17.981|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||17.981|0.636|0.1571
73972181|NCT04447040|147485035|SUPERIORITY||LS Mean Difference|35.66|STANDARD_ERROR_OF_MEAN|6.542|<|0.001|TWO_SIDED|95.0|22.79|48.54|||ANOVA|||||48.54|22.79|<0.001
73972182|NCT04447040|147485035|SUPERIORITY||LS Mean Difference|49.04|STANDARD_ERROR_OF_MEAN|6.407|<|0.001|TWO_SIDED|95.0|36.44|61.65|||ANOVA|||||61.65|36.44|<0.001
73972183|NCT04447040|147485035|SUPERIORITY||LS Mean Difference|53.64|STANDARD_ERROR_OF_MEAN|6.437|<|0.001|TWO_SIDED|95.0|40.97|66.31|||ANOVA|||||66.31|40.97|<0.001
73972184|NCT04447040|147485035|SUPERIORITY||LS Mean Difference|60.93|STANDARD_ERROR_OF_MEAN|6.472|<|0.001|TWO_SIDED|95.0|48.19|73.67|||ANOVA|||||73.67|48.19|<0.001
73972185|NCT04447040|147485035|SUPERIORITY||LS Mean Difference|67.58|STANDARD_ERROR_OF_MEAN|6.65|<|0.001|TWO_SIDED|95.0|54.49|80.67|||ANOVA|||||80.67|54.49|<0.001
73972186|NCT04447040|147485036|SUPERIORITY||LS mean Difference|12.53|STANDARD_ERROR_OF_MEAN|3.097|<|0.001|TWO_SIDED|95.0|6.44|18.63|||ANOVA|||||18.63|6.44|<0.001
73933940|NCT00097591|147397959|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.002|TWO_SIDED|95.0|0.726|0.927||The primary outcome measure was analyzed first in the UA/NSTEMI population, followed by All ACS subjects, followed by the STEMI population.|Gehan-Wilcoxon|||For UA/NSTEMI population||0.927|0.726|0.002
73933941|NCT00097591|147397959|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.019|TWO_SIDED|95.0|0.649|0.968|||Gehan-Wilcoxon|||For STEMI population||0.968|0.649|0.019
73933942|NCT00097591|147397959|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.812|||<|0.001|TWO_SIDED|95.0|0.732|0.902|||Gehan-Wilcoxon|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For All ACS population||0.902|0.732|<0.001
73933943|NCT00097591|147397960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.314||||0.002|TWO_SIDED|95.0|1.107|1.559|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major or Minor Bleeding||1.559|1.107|0.002
73933944|NCT00097591|147397960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.315||||0.029|TWO_SIDED|95.0|1.028|1.683|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major Bleeding||1.683|1.028|0.029
73933945|NCT00097591|147397960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.517||||0.015|TWO_SIDED|95.0|1.083|2.126|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - Life-threatening events (LT)||2.126|1.083|0.015
73933946|NCT00097591|147397960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.191||||0.002|TWO_SIDED|95.0|1.158|11.113|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Fatal||11.113|1.1580|0.002
73972187|NCT04447040|147485036|SUPERIORITY||LS MEAN Difference|17.73|STANDARD_ERROR_OF_MEAN|3.032|<|0.001|TWO_SIDED|95.0|11.76|23.7|||ANOVA|||||23.70|11.76|<0.001
73972188|NCT04447040|147485036|SUPERIORITY||LS Mean Difference|21.88|STANDARD_ERROR_OF_MEAN|3.047|<|0.001|TWO_SIDED|95.0|15.89|27.88|||ANOVA|||||27.88|15.89|<0.001
73933947|NCT00097591|147397960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.119||||0.736|TWO_SIDED|95.0|0.582|2.152|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Symptomatic intracranial hemorrage (ICH)||2.152|0.582|0.736
73972189|NCT04447040|147485036|SUPERIORITY||LS Mean Difference|25.01|STANDARD_ERROR_OF_MEAN|3.063|<|0.001|TWO_SIDED|95.0|18.98|31.03|||ANOVA|||||31.03|18.98|<0.001
73972190|NCT04447040|147485036|SUPERIORITY||LS Mean Difference|29.3|STANDARD_ERROR_OF_MEAN|3.148|<|0.001|TWO_SIDED|95.0|23.11|35.5|||ANOVA|||||35.50|23.11|<0.001
73933948|NCT00097591|147397960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.617||||0.016|TWO_SIDED|95.0|1.159|5.908|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring inotropes||5.908|1.159|0.016
73933949|NCT00097591|147397960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.998||||0.995|TWO_SIDED|95.0|0.528|1.885|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring surgical intervention||1.885|0.528|0.995
73933950|NCT00097591|147397960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.499||||0.084|TWO_SIDED|95.0|0.945|2.379|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring transfusion (\>=4 units)||2.379|0.945|0.084
73933951|NCT00097591|147397960|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.313||||0.022|TWO_SIDED|95.0|1.04|1.656|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Minor Bleeding||1.656|1.040|0.022
73933952|NCT00097591|147397961|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.784|||<|0.001|TWO_SIDED|95.0|0.688|0.894|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days||0.894|0.688|<0.001
73933953|NCT00097591|147397961|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794|||<|0.001|TWO_SIDED|95.0|0.703|0.896|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days||0.896|0.703|<0.001
73933954|NCT00097591|147397962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.767|||<|0.001|TWO_SIDED|95.0|0.672|0.876|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days||0.876|0.672|<0.001
73933955|NCT00097591|147397962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797|||<|0.001|TWO_SIDED|95.0|0.705|0.901|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days||0.901|0.705|<0.001
73972191|NCT04447040|147485037|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
73972192|NCT04447040|147485037|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
73972193|NCT04447040|147485037|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
73972194|NCT04447040|147485037|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
73972195|NCT04447040|147485037|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
73972196|NCT04447040|147485038|SUPERIORITY|||||||0.014|||||||Wald method|||||||0.014
73972197|NCT04447040|147485038|SUPERIORITY|||||||0.002|||||||Wald method|||||||0.002
73972198|NCT04447040|147485038|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
73972199|NCT04447040|147485038|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
73972200|NCT04447040|147485038|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
73972201|NCT01208662|147485039|SUPERIORITY||Hazard Ratio (HR)|1.53|||<|0.001|TWO_SIDED|95.0|1.23|1.91|||Log Rank|Observed Stratified Log Rank Test (1-sided p-value)||||1.91|1.23|<0.001
73972202|NCT01208662|147485040|SUPERIORITY|||||||0.55|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.55
73972203|NCT01208662|147485041|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.99
73972204|NCT01208662|147485042|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.99
73972205|NCT01208662|147485044|SUPERIORITY||Hazard Ratio (HR)|1.66|||<|0.001|TWO_SIDED|99.29|1.21|2.27|||Log Rank|Stratified||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||2.27|1.21|<0.001
74088811|NCT03028740|147730644|SUPERIORITY||Percentage Difference|-1.7||||0.2827|TWO_SIDED|95.0|-4.8|1.5||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|Cochran-Mantel-Haenszel|||||1.5|-4.8|0.2827
73933956|NCT00097591|147397963|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.838|||<|0.001|TWO_SIDED|95.0|0.762|0.921|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||||0.921|0.762|<0.001
73933957|NCT00097591|147397964|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.831|||<|0.001|TWO_SIDED|95.0|0.751|0.919|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||||0.919|0.751|<0.001
73933958|NCT01282710|147397965|SUPERIORITY_OR_OTHER|||||||0.04627||95.0|||||Mixed Models Analysis|||"Agreement between SureCALL® and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."||||.04627
73933959|NCT01282710|147397965|SUPERIORITY_OR_OTHER|||||||0.1676||95.0|||||Mixed Models Analysis|||"Agreement between TOCO and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."||||0.1676
73933960|NCT00009737|147397966|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25 in a first step, and then of 1.20 in a second step.|Hazard Ratio (HR)|0.87||||0.053|TWO_SIDED|95.0|0.75|1.0||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||1.00|0.75|0.053
73933961|NCT00009737|147397967|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.86||||0.041|TWO_SIDED|95.0|0.74|0.99||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||0.99|0.74|0.041
73933962|NCT00009737|147397968|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.84||||0.071|TWO_SIDED|95.0|0.69|1.01||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||1.01|0.69|0.071
73933963|NCT01807585|147397972|NON_INFERIORITY|Non-inferiority was determined by the application of a Z-test with a 10% non-inferiority margin as well as examination of confidence intervals.|Risk Difference (RD)|3.5|||<|0.0001|TWO_SIDED|95.0|-0.7|7.6|||One tailed Z-test|||Last Observation Carried Forward (LOCF)||7.6|-0.7|<0.0001
73933964|NCT02504645|147397976|SUPERIORITY|||||||0.2631|TWO_SIDED|0.0|||||Chi-squared|||||||0.2631
73933965|NCT00701389|147397989|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 90% CI is less than 5 mmHg, the primary hypothesis would be supported.|Difference in Least Squares Means|1.5|||||TWO_SIDED|90.0|0.0|3.0|||Mixed Effect Model|||100 mg sumatriptan/600 mg telcagepant minus 100 mg sumatriptan/telcagepant placebo||3.0|0.0|
73933966|NCT00701389|147397990|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.2|||||TWO_SIDED|90.0|-0.2|2.7|||Mixed Effect Model|||sumatriptan placebo/600 mg telcagepant minus sumatriptan placebo/telcagepant placebo||2.7|-0.2|
73933967|NCT04808609|147397993|OTHER|feasibility test|Risk Ratio (RR)|1.27|STANDARD_ERROR_OF_MEAN|1.63||0.77|TWO_SIDED|95.0|0.24|6.76|||Fisher Exact|||||6.76|0.24|0.77
73933968|NCT04808609|147397994|OTHER|feasibility test|Risk Ratio (RR)|1.27|STANDARD_ERROR_OF_MEAN|0.84||0.66|TWO_SIDED|95.0|0.43|3.78|||Chi-squared|||||3.78|0.43|0.66
73933969|NCT04808609|147397995|OTHER|feasibility test|Cohen's D|0.21|STANDARD_ERROR_OF_MEAN|0.33||0.59|TWO_SIDED|95.0|-0.44|0.86|||t-test, 2 sided|||||0.86|-0.44|0.59
73933970|NCT04808609|147397995|OTHER|feasibility|Cohen's D|0.41|STANDARD_ERROR_OF_MEAN|0.17||0.02|TWO_SIDED|95.0|0.07|0.74|||t-test, 1 sided|||Results from Paired T-Test assessing the with-subject time effect on exhaled CO in ppm from baseline to 12 weeks||0.74|0.07|0.02
73933971|NCT04808609|147397996|OTHER|feasibility test|Cohen's D|0.16|STANDARD_ERROR_OF_MEAN|0.31||0.61|TWO_SIDED|95.0|-0.46|0.78|||t-test, 2 sided|||||0.78|-0.46|0.61
73933972|NCT04808609|147397997|OTHER|feasibility test|Cohen's D|0.19|STANDARD_ERROR_OF_MEAN|0.31||0.55|TWO_SIDED|95.0|-0.42|0.8|||t-test, 2 sided|||||0.80|-0.42|0.55
73933973|NCT04808609|147397998|OTHER|feasibility test|Cohen's D|0.004|STANDARD_ERROR_OF_MEAN|0.31||0.99|TWO_SIDED|95.0|-0.61|0.62|||t-test, 2 sided|||||0.62|-0.61|0.99
73933974|NCT04177693|147398024|SUPERIORITY|||||||0.112|||||||Kruskal-Wallis|||||||0.112
73933975|NCT04177693|147398025|SUPERIORITY|||||||0.613|||||||Kruskal-Wallis|||||||0.613
73933976|NCT04177693|147398026|SUPERIORITY|||||||0.202|||||||Kruskal-Wallis|||||||0.202
73933977|NCT04177693|147398027|SUPERIORITY|||||||0.508|||||||Kruskal-Wallis|||||||0.508
73933978|NCT04177693|147398028|SUPERIORITY|||||||0.237|||||||Kruskal-Wallis|||||||0.237
73933979|NCT04177693|147398029|SUPERIORITY|||||||0.327|||||||Kruskal-Wallis|||||||0.327
73933980|NCT04177693|147398030|SUPERIORITY|||||||0.633|||||||Kruskal-Wallis|||||||0.633
73933981|NCT04177693|147398031|SUPERIORITY|||||||0.146|||||||Kruskal-Wallis|||||||0.146
73933982|NCT04177693|147398032|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
73933983|NCT04177693|147398033|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
73933984|NCT04177693|147398034|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
73972206|NCT01208662|147485045|SUPERIORITY||Hazard Ratio (HR)|1.1|||>|0.99|TWO_SIDED|95.0|0.73|1.65|||Log Rank|||||1.65|0.73|>0.99
73972207|NCT01208662|147485047|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.99|TWO_SIDED|99.29|0.73|1.65|||Log Rank|Stratified||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||1.65|0.73|0.99
73972208|NCT01208662|147485054|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.3|1.01||||||||1.01|0.30|
73972209|NCT04731129|147485056|SUPERIORITY|||||||0.023||||||threshold for statistical significance \< 0.05|Fisher Exact|||Abnormal tissular architecture||||0.023
73972210|NCT04731129|147485056|SUPERIORITY|||||||0.01||||||Threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell size||||0.01
73972211|NCT04731129|147485056|SUPERIORITY|||||||0.01||||||threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell shape||||0.01
73972212|NCT04731129|147485056|SUPERIORITY|||||||0.013||||||threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell fluorescence||||0.013
73933985|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-8.6|||||TWO_SIDED|95.0|-12.1|-5.1||||||Serotype 1: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-5.1|-12.1|
73933986|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-15.5|||||TWO_SIDED|95.0|-20.1|-10.8||||||Serotype 3: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||-10.8|-20.1|
73933987|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-8.4|||||TWO_SIDED|95.0|-12.0|-4.9||||||Serotype 4: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-4.9|-12.0|
73933988|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-4.3|||||TWO_SIDED|95.0|-7.8|-0.8||||||Serotype 5: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-0.8|-7.8|
73933989|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-2.4|||||TWO_SIDED|95.0|-4.6|-0.2||||||Serotype 6A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-0.2|-4.6|
73933990|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-4.1|||||TWO_SIDED|95.0|-7.0|-1.2||||||Serotype 6B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-1.2|-7.0|
73933991|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-1.0|||||TWO_SIDED|95.0|-2.7|0.7||||||Serotype 7F: 2-sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.7|-2.7|
73972213|NCT04731129|147485056|SUPERIORITY|||||||0.16||||||threshold for statistical significance \< 0.05|Fisher Exact|||Blood vessel dysplasia||||0.16
73972214|NCT04731129|147485056|SUPERIORITY|||||||0.17||||||threshold for statistical significance \< 0.05|Fisher Exact|||Organized conjunctive fibers||||0.17
73933992|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-7.9|||||TWO_SIDED|95.0|-11.3|-4.6||||||Serotype 9V: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-4.6|-11.3|
73933993|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-0.8|||||TWO_SIDED|95.0|-3.1|1.6||||||Serotype 14: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||1.6|-3.1|
73972215|NCT04731129|147485056|SUPERIORITY|||||||0.049||||||threshold for statistical significance \< 0.05|Fisher Exact|||Full chia seed sign||||0.049
73972216|NCT04731129|147485056|SUPERIORITY|||||||0.0041||||||threshold for statistical significance \< 0.05|Fisher Exact|||General physician conclusion||||0.0041
73972217|NCT03643744|147485074|SUPERIORITY|||||||0.53|||||||ANOVA|||||||0.530
73972218|NCT03643744|147485074|SUPERIORITY|||||||0.727|||||||ANOVA|||||||0.727
73972219|NCT03643744|147485075|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73972220|NCT04685135|147485103|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.76|||Log Rank|HR and CI are from stratified Cox proportional hazard model||||0.76|0.45|<0.0001
73972221|NCT04685135|147485105|SUPERIORITY||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|2.56|8.56|||Cochran Mantel Haenszel chi-square test|||||8.56|2.56|<0.0001
74030426|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|0.73||||0.31|TWO_SIDED|95.0|0.39|1.34||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - EC can prevent pregnancy after sex||1.34|0.39|0.31
74088812|NCT03028740|147730644|SUPERIORITY||Odds Ratio (OR)|0.7844|||||TWO_SIDED|95.0|0.5032|1.2229|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.2229|0.5032|
73972222|NCT04911296|147485152|OTHER|||||||0.935|||||||Fisher Exact|||||||0.935
73972223|NCT04911296|147485153|OTHER|||||||0.536|||||||Fisher Exact|||||||0.536
73972224|NCT01236781|147485181|EQUIVALENCE|no margin is assumed.||||||0.46||||||1 degree of freedom;|McNemar|Exact test||"To account for the paired nature of the design, McNemar's test will be used to compare the call-back rates.~H0: assumes no difference between the tests (modalities)"||||0.46
73972225|NCT01236781|147485184|EQUIVALENCE|no equivalence margin||||||0.2188||||||Due to the paired nature of the data an exact McNemar's Test is used|McNemar|Exact test||H0: no difference between the 2 modalities||||0.2188
73865590|NCT01939366|147276926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.39||0.0564|TWO_SIDED|95.0|-1.5|0.02||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||0.02|-1.50|0.0564
73865591|NCT01939366|147276926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.41||0.0153|TWO_SIDED|95.0|-1.83|-0.2||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||-0.20|-1.83|0.0153
73865592|NCT00680797|147276927|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED|||||Comparison of pre- to post-intervention insulin levels between the groups receiving E only versus the group receiving no hormone replacement.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.||||0.023
73865593|NCT00680797|147276927|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||Comparison in the change in insulin levels between the groups receiving E with or without T.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.||||0.042
73865594|NCT00151476|147276946|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|14.49||||||95.0|3.48|301.64|||||Kaplan-Meier Estimate of Time to Event (months).|"Time to FAP-related surgical events (months); twenty-fifth (25th) percentile presented due to limited number of subjects.~Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.~Only 13 matched pairs identified: p-values not computed in analysis of time-to-event endpoints"||301.64|3.48|
73865595|NCT00151476|147276946|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.06||||||95.0|3.48|11.76|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||11.76|3.48|
73865596|NCT00151476|147276946|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.52||||||95.0|3.48|14.49|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||14.49|3.48|
73865597|NCT00151476|147276947|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.98||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||33.77|0.00|
73865598|NCT00151476|147276947|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||33.77|0.00|
73865599|NCT00151476|147276948|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|137.34||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile. Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.||183.48|104.73|
73865600|NCT00151476|147276948|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|169.94||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||183.48|104.73|
73933994|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.9||||||Serotype 18C: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||1.9|-3.1|
73972226|NCT04587453|147485223|OTHER|No formal testing was performed. Confidence intervals (CIs) are presented with two sided 95% degree of confidence.|Risk Difference (RD)|5.7|||||TWO_SIDED|95.0|-11.2|22.5|||||Mantel-Haenzel risk difference, stratified by baseline IGA.|Responders were considered those meeting an IGA score of 0 or 1 (clear or almost clear). Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.||22.5|-11.2|
73972227|NCT04587453|147485224|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-2.9|33.0|||||Mantel-Haenzel risk difference, stratified by baseline IGA.|Subjects with 75% reduction in EASI were considered responders. Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.||33.0|-2.9|
73972228|NCT04587453|147485225|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-5.1|||||TWO_SIDED|95.0|-12.4|2.3|||||Analysis of covariance (ANCOVA). Worst observation carried forward for all subjects who prior to Week 16 had received rescue medication. Multiple imputation of missing values for subjects who had not received rescue medication.|||2.3|-12.4|
73865601|NCT00151476|147276949|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|11.28||||||95.0|9.07|38.24|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||38.24|9.07|
73865602|NCT00151476|147276950|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|20.63||||||95.0|8.05|48.03|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||48.03|8.05|
73933995|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-1.0|||||TWO_SIDED|95.0|-2.6|0.5||||||Serotype 19A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.5|-2.6|
73933996|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|0.2|||||TWO_SIDED|95.0|-1.5|2.0||||||Serotype 19F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||2.0|-1.5|
73933997|NCT04382326|147398066|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-7.6|||||TWO_SIDED|95.0|-11.4|-3.9||||||Serotype 23F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-3.9|-11.4|
73933998|NCT04382326|147398066|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|11.2|||||TWO_SIDED|95.0|8.6|14.0||||||Serotype 8: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||14.0|8.6|
73933999|NCT04382326|147398066|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|-3.3|||||TWO_SIDED|95.0|-6.9|0.3||||||Serotype 10A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.3|-6.9|
73934000|NCT04382326|147398066|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|7.1||||||95.0|4.2|10.2||||||Serotype 11A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||10.2|4.2|
73934001|NCT04382326|147398066|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|-18.1|||||TWO_SIDED|95.0|-22.1|-14.0||||||Serotype 12F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-14.0|-22.1|
73934002|NCT04382326|147398066|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|12.7|||||TWO_SIDED|95.0|10.2|15.4||||||Serotype 15B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||15.4|10.2|
73934003|NCT04382326|147398066|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|12.8|||||TWO_SIDED|95.0|10.3|15.5||||||Serotype 22F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||15.5|10.3|
73934004|NCT04382326|147398066|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|1.1|||||TWO_SIDED|95.0|-2.2|4.5||||||Serotype 33F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||4.5|-2.2|
73934005|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.69|||||TWO_SIDED|95.0|0.63|0.76||||||Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.76|0.63|
73934006|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.61|0.73||||||Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.73|0.61|
73972229|NCT04587453|147485226|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-2.7|0.5|||||ANCOVA. Worst observation carried forward for all subjects who prior to Week 16 had received rescue medication. Multiple imputation of missing values for subjects who had not received rescue medication.|||0.5|-2.7|
74088813|NCT03028740|147730645|SUPERIORITY||Percentage Difference|-2.7||||0.4054|TWO_SIDED|95.0|-8.7|3.3||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|Cochran-Mantel-Haenszel|||||3.3|-8.7|0.4054
73934007|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.78||||||95.0|0.7|0.86||||||Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.70|
73934008|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82||||||Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.67|
73934009|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.7|0.85||||||Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.85|0.70|
73934010|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7|||||TWO_SIDED|95.0|0.62|0.79||||||Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.79|0.62|
73934011|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.76|||||TWO_SIDED|95.0|0.7|0.82||||||Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.70|
73972230|NCT04587453|147485227|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|-3.8|||||TWO_SIDED|95.0|-21.7|14.2|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with at least a reduction of 4 in the worst daily pruritus NRS score were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data at Week 16 were imputed as non-responders.||14.2|-21.7|
73972231|NCT04587453|147485228|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-3.0|33.2|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with a reduction of 90% in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.||33.2|-3.0|
73972232|NCT04587453|147485229|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|5.7|||||TWO_SIDED|95.0|-9.0|20.3|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with at least 50% reduction in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.||20.3|-9.0|
73972233|NCT04587453|147485230|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-14.9|6.3|||||Repeated measurements Model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||6.3|-14.9|
73972234|NCT04587453|147485231|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.7|0.8|||||Repeated measurements Model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||0.8|-0.7|
73972235|NCT04587453|147485232|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.9|0.6|||||Repeated measurements model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 1 change imputed as 0 if no post-baseline assessments.|||0.6|-0.9|
73972236|NCT04587453|147485233|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-5.6|-0.9|||||Repeated measurements model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||-0.9|-5.6|
74030427|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|1.33||||0.08|TWO_SIDED|95.0|0.96|1.84||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pill does not affect fertility||1.84|0.96|0.08
74088814|NCT03028740|147730645|SUPERIORITY||Odds Ratio (OR)|0.8877|||||TWO_SIDED|95.0|0.6709|1.1744|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.1744|0.6709|
73865603|NCT00151476|147276950|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|40.21||||||95.0|8.31|105.68|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||105.68|8.31|
73865604|NCT00151476|147276950|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|16.03|56.34|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||56.34|16.03|
73865605|NCT00151476|147276950|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|20.22||||||95.0|12.35|40.31|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||40.31|12.35|
73865606|NCT00151476|147276952|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|21.22||||||95.0|4.07|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.||64.16|4.07|
73934012|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.8||||||95.0|0.73|0.88||||||Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.88|0.73|
73865607|NCT00151476|147276952|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|3.68|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.||64.16|3.68|
74091648|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|23.85|||||TWO_SIDED|95.0|8.64|65.82|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23B||65.82|8.64|
73865608|NCT03446456|147276959|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in changes of BOLD signal in the brain.|Mean Difference (Final Values)|0.00264||||0.982|TWO_SIDED|||||Bonferroni corrected|t-test, 2 sided|||Percentage of BOLD signal change was calculated as the BOLD signal in the right supplementary motor area (SMA, a typical brain area responding to pain stimulation), divided by the BOLD signal of the whole-brain average during the 24 trials of 20-second painful stimulations. The percentage of BOLD signal changes in SMA during the 20-second painful stimulations were compared between the Saline group and the Vasopressin group using an equivalence test.||||0.982
73865609|NCT03446456|147276960|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in heating temperature that was used for the testing phase.|Mean Difference (Final Values)|-0.282||||0.269|TWO_SIDED|||||Bonferroni corrected|ANCOVA|The drug group (Vasopressin vs. Saline) was set as a between-subject factor. Age and race were treated as covariates.||||||0.269
73865610|NCT03446456|147276961|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in implicit racial biases.|Mean Difference (Final Values)|-0.04||||0.378|TWO_SIDED||||||ANCOVA|Drug group (Vasopressin vs. Saline) was set as between-subject factor. Age and race were treated as covariates.||"Response latencies were recorded to calculate the IAT difference score (D). A difference score (D) was calculated based on the following steps: 1) Compute the standard deviation (SD) of response latencies from overall trials; 2) M1 is the mean of the response latencies in the condition where White people and good share the same response key. M2 is the mean of the latencies in the condition where African-American/Asian people and good share the same response key; 3) D = (M2-M1)/SD."||||0.378
73865611|NCT03446456|147276962|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in self-reported pain intensity ratings.|Mean Difference (Final Values)|-2.35||||0.014|TWO_SIDED|||||Bonferroni corrected|Mixed Models Analysis|Age, race, and heating temperature used during the testing phase were treated as covariates.||||||0.014
73865612|NCT04099511|147276984|SUPERIORITY|||||||0.693|||||||Wilcoxon (Mann-Whitney)|||||||.693
73865613|NCT04099511|147276985|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||||||.536
73865614|NCT04099511|147276986|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||.260
73865615|NCT04099511|147276987|SUPERIORITY|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||||||.387
73865616|NCT04099511|147276988|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
73865617|NCT04099511|147276989|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
73865618|NCT04099511|147276990|SUPERIORITY|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||||||0.388
73865619|NCT04099511|147276991|SUPERIORITY|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
73865620|NCT03002311|147277013|SUPERIORITY|We conducted a conditional power analysis 120 days after 6 months of enrollment. We determined the effect size based on the difference of proportions of follow-up attendance in the intervention and control arms. We used the effect size of 20% to estimate the sample size needed for a two-sided alpha of 0.05 at 90% power and a 1:1 ratio to require 266 participants. Loss to follow-up was estimated to be 20%, increasing target enrollment to 334 total participants.|||||<|0.001|||||||Gray's test|We compared the cumulative incidence function.||||||<0.001
73865621|NCT03002311|147277014|SUPERIORITY|This was a secondary analysis so no power analysis was done.||||||0.8||||||We used a two-sided alpha of 0.05 to determine significance.|Gray's test|We compared the cumulative incidence functions.||||||0.8
73865622|NCT03270891|147277031|SUPERIORITY|Null hypothesis of equality.||||||0.0115|||||||t-test, 2 sided|||Baseline and 6 month values||||0.0115
73865623|NCT03270891|147277031|SUPERIORITY|Null hypothesis of equality.||||||0.027|||||||t-test, 2 sided|||baseline to 6 month comparison||||0.027
73865624|NCT03270891|147277032|SUPERIORITY|Null hypothesis of equality.||||||0.0327|||||||t-test, 2 sided|||Baseline p value to six month||||0.0327
73865625|NCT03270891|147277032|SUPERIORITY|Null hypothesis of equality.||||||0.2088|||||||t-test, 2 sided|||baseline to 6 month comparison p value||||0.2088
73865626|NCT03270891|147277033|SUPERIORITY|Null hypothesis of equality.||||||0.947|||||||t-test, 2 sided|||baseline to 6 month comparison||||0.947
73865627|NCT02883062|147277049|SUPERIORITY|||||||0.36|||||||Generalized estimating equation (GEE)|||||||0.36
73865628|NCT02883062|147277050|SUPERIORITY|||||||0.018|||||||Regression, Logistic|||||||0.018
74091649|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|39.39|||||TWO_SIDED|95.0|14.15|109.65|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23B||109.65|14.15|
73865629|NCT02888743|147277058|SUPERIORITY||Difference between proportions|0.0||||0.99|TWO_SIDED|90.0|-14.6|14.6|||Chi-squared||Arm A compared with Arm C; normal approximation for confidence interval|||14.6|-14.6|0.99
73865630|NCT02888743|147277058|SUPERIORITY||Difference between proportions|-3.8||||0.64|TWO_SIDED|90.0|-17.3|9.6|||Chi-squared||Arm B compared with Arm C; normal approximation used for confidence interval.|||9.6|-17.3|0.64
73865631|NCT02888743|147277059|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.92|TWO_SIDED|90.0|0.6|1.58|||Regression, Cox|||||1.58|0.60|0.92
73865632|NCT02888743|147277059|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.55|TWO_SIDED|90.0|0.5|1.38|||Regression, Cox|||||1.38|0.50|0.55
73934013|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.81|1.0||||||Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.00|0.81|
73934014|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.74||||||95.0|0.67|0.82||||||Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.67|
73934015|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.94||||||Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.94|0.77|
73934016|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.78|0.96||||||Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.96|0.78|
73934017|NCT04382326|147398067|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.64|||||TWO_SIDED|95.0|0.57|0.72||||||Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.72|0.57|
73934018|NCT04382326|147398067|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.87|||||TWO_SIDED|95.0|1.71|2.06||||||Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||2.06|1.71|
73934019|NCT04382326|147398067|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.94||||||95.0|2.64|3.26||||||Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||3.26|2.64|
74030428|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.2|2.26||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.||Comparison of correct knowledge - patch does not affect fertility|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|2.26|1.2|0.002
74030429|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|1.7||||0.002|TWO_SIDED|95.0|1.23|2.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - ring does not affect fertility||2.35|1.23|0.002
73865633|NCT02888743|147277060|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.24|TWO_SIDED|90.0|0.3|1.22|||Regression, Cox|||||1.22|0.30|0.24
73865634|NCT02888743|147277060|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.44|TWO_SIDED|90.0|0.36|1.45|||Regression, Cox|||||1.45|0.36|0.44
73865635|NCT02888743|147277064|SUPERIORITY|||||||0.68||||||Unadjusted p-value.|Wilcoxon (Mann-Whitney)|||||||0.68
73865636|NCT06225466|147277065|SUPERIORITY||least squares mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.013||0.123|TWO_SIDED|95.0|-0.005|0.047|||ANOVA|||||0.047|-0.005|0.123
73865637|NCT06225466|147277066|SUPERIORITY||Odds Ratio (OR)|0.55||||0.102|TWO_SIDED|95.0|0.26|1.12|||Mixed Models Analysis|||||1.12|0.26|0.102
73865638|NCT06225466|147277067|SUPERIORITY||Incidence rate ratio|2.37||||0.008|TWO_SIDED|95.0|1.25|4.52|||Negative Binomial Regression|||||4.52|1.25|0.008
73865639|NCT04816721|147277118|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.96||||0.1249|TWO_SIDED|95.0|-2.21|0.28|||Mixed-effect Model of Repeated Measures|||Day 3: EDP-938 Versus Placebo||0.28|-2.21|0.1249
73865640|NCT04816721|147277118|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-1.41||||0.058|TWO_SIDED|95.0|-2.88|0.05|||Mixed-effect Model of Repeated Measures|||Day 5: EDP-938 Versus Placebo||0.05|-2.88|0.0580
73865641|NCT04816721|147277118|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.43||||0.5877|TWO_SIDED|95.0|-2.02|1.16|||Mixed-effect Model of Repeated Measures|||Day 9: EDP-938 Versus Placebo||1.16|-2.02|0.5877
73972241|NCT04047602|147485304|EQUIVALENCE|The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.|Binomial Proportion|0.083||||0.234|TWO_SIDED|95.0|0.002|0.385||The p-value reported is the one-sided p-value from the exact equivalence binomial test using an alpha value of 0.05.|Exact Binomial Test||The binomial proportion 95% confidence intervals were calculated using the Clopper-Pearson (Exact) method.|The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.||0.385|0.002|0.234
73972242|NCT04047602|147485307|OTHER|||||||0.285|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.||||0.285
73972243|NCT04047602|147485308|OTHER|||||||0.292|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.||||0.292
73972244|NCT04047602|147485309|OTHER|||||||0.289|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.||||0.289
73972245|NCT04047602|147485312|OTHER|||||||0.248|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.||||0.248
74030430|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|0.94||||0.77|TWO_SIDED|95.0|0.62|1.43||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Depo does affect fertility||1.43|0.62|0.77
73865642|NCT04816721|147277118|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|0.84||||0.2932|TWO_SIDED|95.0|-0.76|2.43|||Mixed-effect Model of Repeated Measures|||Day 14: EDP-938 Versus Placebo||2.43|-0.76|0.2932
73972246|NCT04047602|147485313|OTHER|||||||0.292|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.||||0.292
74091650|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|19.88|||||TWO_SIDED|95.0|9.03|43.74|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 24F||43.74|9.03|
74091651|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|31.07|||||TWO_SIDED|95.0|13.98|69.03|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 24F||69.03|13.98|
73972247|NCT04047602|147485314|OTHER|||||||0.289|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.||||0.289
73972248|NCT05828017|147485325|SUPERIORITY||Mean Difference (Final Values)|1.107|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
73865643|NCT04816721|147277119|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.17||||0.6574|TWO_SIDED|95.0|-0.93|0.59|||Mixed-effect Model of Repeated Measures|||Day 3: EDP-938 Versus Placebo||0.59|-0.93|0.6574
73934020|NCT04382326|147398067|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.67|||||TWO_SIDED|95.0|1.51|1.84||||||Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.84|1.51|
73934021|NCT04382326|147398067|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.88||||||95.0|0.79|0.97||||||Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.97|0.79|
73934022|NCT04382326|147398067|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.95||||||95.0|5.39|6.55||||||Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||6.55|5.39|
73934023|NCT04382326|147398067|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.01||||||95.0|4.54|5.52||||||Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||5.52|4.54|
73934024|NCT04382326|147398067|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.4|||||TWO_SIDED|95.0|3.99|4.85||||||Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||4.85|3.99|
73934025|NCT04382326|147398068|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-4.3|||||TWO_SIDED|95.0|-7.5|-1.4||||||Diphtheria: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||-1.4|-7.5|
73934026|NCT04382326|147398068|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.3|||||TWO_SIDED|95.0|-1.0|1.7||||||Tetanus: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||1.7|-1.0|
73934027|NCT04382326|147398068|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-0.2||||||95.0|-3.5|3.1||||||Pertussis (PT): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.1|-3.5|
73934028|NCT04382326|147398068|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.6||||||95.0|-2.5|3.9||||||Pertussis (FHA): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.9|-2.5|
73934029|NCT04382326|147398068|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-1.3||||||95.0|-4.7|2.2||||||Pertussis (PRN): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.2-Sided CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||2.2|-4.7|
73865644|NCT04816721|147277119|SUPERIORITY||Least Squares Mean Difference|-0.33||||0.4728|TWO_SIDED|95.0|-1.23|0.58|||Mixed-effect Model of Repeated Measures|||Day 5: EDP-938 Versus Placebo||0.58|-1.23|0.4728
73934030|NCT04382326|147398068|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.2|2.9||||||HBsAg: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||2.9|-3.2|
73934031|NCT04382326|147398068|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.4|3.2||||||Poliovirus (Type 1): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.2|-3.4|
73972249|NCT05828017|147485325|SUPERIORITY||Mean Difference (Final Values)|0.544||||0.015|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference between Variation #1 and the standard curve in terms of mean preference counts per participant.||||0.015
73865645|NCT04816721|147277119|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.7||||0.2058|TWO_SIDED|95.0|-1.79|0.39|||Mixed-effect Model of Repeated Measures|||Day 9: EDP-938 Versus Placebo||0.39|-1.79|0.2058
73865646|NCT04816721|147277119|OTHER|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|0.33||||0.5391|TWO_SIDED|95.0|-0.74|1.41|||Mixed-effect Model of Repeated Measures|||Day 14: EDP-938 Versus Placebo||1.41|-0.74|0.5391
73865647|NCT04816721|147277121|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.17||||0.6574|TWO_SIDED|95.0|-0.93|0.59|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 3: EDP-938 Versus Placebo||0.59|-0.93|0.6574
73865648|NCT04816721|147277121|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.67||||0.5359|TWO_SIDED|95.0|-2.81|1.47|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 5: EDP-938 Versus Placebo||1.47|-2.81|0.5359
73865649|NCT04816721|147277121|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-2.73||||0.3029|TWO_SIDED|95.0|-7.95|2.5|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 9: EDP-938 Versus Placebo||2.50|-7.95|0.3029
73865650|NCT04816721|147277121|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-3.64||||0.3871|TWO_SIDED|95.0|-11.98|4.69|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 14: EDP-938 Versus Placebo||4.69|-11.98|0.3871
73865651|NCT00997620|147277234|OTHER||Mean Difference (Net)|0.5|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||The statistical analysis was of t testing of the difference of the mean between the baseline and after two weeks. The power analysis was prior to data collection was not performed for this test. The null hypothesis is no different, no difference between placebo and active treatment.||||< .05
73865652|NCT00300365|147277244|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73865653|NCT01716104|147277252|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
73865654|NCT01716104|147277253|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
73865655|NCT01716104|147277254|SUPERIORITY|||||||0.0008|||||||Mixed Models Analysis|||||||0.0008
73865656|NCT01716104|147277255|SUPERIORITY|||||||0.0011|||||||Mixed Models Analysis|||||||0.0011
73865657|NCT01716104|147277256|SUPERIORITY|||||||0.0054|||||||Mixed Models Analysis|||||||0.0054
73865658|NCT01716104|147277257|SUPERIORITY|||||||0.0437|||||||Mixed Models Analysis|||||||0.0437
73865659|NCT01716104|147277258|SUPERIORITY|||||||0.0862|||||||Mixed Models Analysis|||||||0.0862
73865660|NCT01716104|147277259|SUPERIORITY|||||||0.0621|||||||Mixed Models Analysis|||||||0.0621
73865661|NCT01716104|147277260|SUPERIORITY|||||||0.0142|||||||Mixed Models Analysis|||||||0.0142
73865662|NCT00129961|147277318|SUPERIORITY_OR_OTHER|||||||0.022||||||Poisson regression was used to model NMSC counts using the years in study as an offset. The generalized estimated equations (GEE) approach was used to estimate parameters and compare treatment differences.|Poisson regression|Adjusted by baseline strata; Poisson model = strata + treatment.||||||0.022
73865663|NCT00129961|147277319|SUPERIORITY_OR_OTHER|||||||0.047|||||||Regression, Cox|Stratified by baseline lesions||||||0.047
73865664|NCT00129961|147277320|SUPERIORITY_OR_OTHER|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||||||0.015
73865665|NCT00129961|147277321|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||Chi-squared|||||||0.799
73865666|NCT00129961|147277322|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Well differentiated||||0.014
73865667|NCT00129961|147277322|SUPERIORITY_OR_OTHER|||||||0.491||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Moderately differentiated||||0.491
73865668|NCT00129961|147277322|SUPERIORITY_OR_OTHER|||||||0.905||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Poorly differentiated||||0.905
73865669|NCT00129961|147277322|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive||||0.018
73934032|NCT04382326|147398068|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.8||||||95.0|-2.4|4.6||||||Poliovirus (Type 2): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||4.6|-2.4|
73934033|NCT04382326|147398068|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.2|3.1||||||Poliovirus (Type 3): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.1|-3.2|
73934034|NCT04382326|147398068|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Hib (≥0.15 μg/mL): 2-Sided CI were calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.0|-3.0|
73934035|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|0.65|||||TWO_SIDED|95.0|0.59|0.72||||||Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.72|0.59|
73934036|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7|||||TWO_SIDED|95.0|0.64|0.76||||||Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.76|0.64|
73934037|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7||||||95.0|0.63|0.78||||||Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.78|0.63|
73934038|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.69||||||95.0|0.61|0.77||||||Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.77|0.61|
73934039|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.72||||||95.0|0.65|0.81||||||Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.81|0.65|
73934040|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.7||||||Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.70|0.51|
73934041|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.75||||||95.0|0.69|0.81||||||Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.81|0.69|
73972250|NCT05828017|147485326|SUPERIORITY||Mean Difference (Final Values)|1.039|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
73972251|NCT05828017|147485326|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.03569|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.03569
73972252|NCT05828017|147485327|SUPERIORITY||Mean Difference (Final Values)|0.365||||0.069|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||0.069
74091652|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|57.79|||||TWO_SIDED|95.0|25.15|132.78|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 31||132.78|25.15|
73934042|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.65|0.8||||||Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.80|0.65|
73934043|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79||||||95.0|0.71|0.89||||||Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.89|0.71|
73934044|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.77||||||95.0|0.7|0.84||||||Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.84|0.70|
73972253|NCT05828017|147485327|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.6976|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.6976
73972254|NCT05828017|147485328|SUPERIORITY||Mean Difference (Final Values)|0.876|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
73972255|NCT05828017|147485328|SUPERIORITY||Mean Difference (Final Values)|0.728||||0.0013|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.0013
73972256|NCT05828017|147485329|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.522|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.522
73972257|NCT05828017|147485329|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.27|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts between the standard curve and variation #1.||||0.27
73972258|NCT05828017|147485330|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.28|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.28
73972259|NCT05828017|147485330|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.11|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.11
73972260|NCT05828017|147485331|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.52|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.52
73972261|NCT05828017|147485331|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.26|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.26
73972262|NCT05828017|147485332|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.16|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.16
73934045|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.86||||||Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.72|
73934046|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79||||||95.0|0.73|0.86||||||Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.73|
73934047|NCT04382326|147398069|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.75||||||Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.75|0.58|
73934048|NCT04382326|147398069|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.98||||||95.0|1.81|2.16||||||Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||2.16|1.81|
73934049|NCT04382326|147398069|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.32||||||95.0|1.18|1.49||||||Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.49|1.18|
73934050|NCT04382326|147398069|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.52||||||95.0|1.39|1.67||||||Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.67|1.39|
73934051|NCT04382326|147398069|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6||||||95.0|0.54|0.67||||||Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.67|0.54|
73972263|NCT05828017|147485332|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.37|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.37
73972264|NCT05828017|147485333|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.08|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.08
73972265|NCT05828017|147485333|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.31|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.31
73972266|NCT05828017|147485334|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.21|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.21
73972267|NCT05828017|147485334|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.085|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.085
73972268|NCT05828017|147485335|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.86|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.86
73972269|NCT05828017|147485335|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||1
73934052|NCT04382326|147398069|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.82|||||TWO_SIDED|95.0|4.39|5.3||||||Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||5.30|4.39|
73934053|NCT04382326|147398069|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.06||||||95.0|3.68|4.48||||||Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||4.48|3.68|
73972270|NCT05828017|147485336|SUPERIORITY||Mean Difference (Final Values)|0.607||||0.009|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.009
73972271|NCT05828017|147485336|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.61|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.61
73972272|NCT05828017|147485337|SUPERIORITY||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.11|1.0|||ANOVA|||This is to see if there is a difference in mean SRT50 scores between the standard curve, variation #1, and no preference counts.||1.00|0.11|<0.001
74091653|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|58.07|||||TWO_SIDED|95.0|25.1|134.33|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 31||134.33|25.10|
73934054|NCT04382326|147398069|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.64||||||95.0|1.46|1.83||||||Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.83|1.46|
73934055|NCT04382326|147398077|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.29||||||95.0|1.05|1.58||||||Measles: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.58|1.05|
73934056|NCT04382326|147398078|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.08|||||TWO_SIDED|95.0|0.85|1.38||||||Mumps: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.38|0.85|
73934057|NCT04382326|147398079|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.23|||||TWO_SIDED|95.0|1.02|1.48||||||Rubella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.48|1.02|
73934058|NCT04382326|147398080|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|0.99|||||TWO_SIDED|95.0|0.84|1.17||||||Varicella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution)||1.17|0.84|
73934059|NCT01762761|147398081|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|26.08|||<|0.001|TWO_SIDED|95.0|7.29|93.26|||Regression, Logistic|||||93.26|7.29|<0.001
73934060|NCT01762761|147398082|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|23.8|||<|0.001|TWO_SIDED|95.0|8.54|66.33|||Regression, Logistic|||||66.33|8.54|<0.001
73934061|NCT01762761|147398083|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.52|||<|0.001|TWO_SIDED|95.0|3.84|18.94|||Regression, Logistic|||||18.94|3.84|<0.001
73934062|NCT01762761|147398084|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.001|TWO_SIDED|95.0|0.13|0.59|||Mixed Models Analysis|||||0.59|0.13|0.001
73934063|NCT01762761|147398085|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.59||||0.306|TWO_SIDED|95.0|0.21|1.64|||Mixed Models Analysis|||||1.64|0.21|0.306
73934064|NCT01762761|147398086|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.12|||<|0.001|TWO_SIDED|95.0|4.01|9.34|||Log Rank|||||9.34|4.01|<0.001
73934065|NCT01762761|147398087|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.05|0.37|||Regression, Logistic|||||0.37|0.05|<0.001
73934066|NCT01762761|147398088|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|16.54||||0.008|TWO_SIDED|95.0|2.09|131.12|||Regression, Logistic|||||131.12|2.09|0.008
73934067|NCT01762761|147398089|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||van Elteren stratified rank test|||||||<0.001
73934068|NCT01762761|147398090|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||van Elteren stratified rank test|||||||<0.001
73934069|NCT03017508|147398111|SUPERIORITY||Mean Difference (Final Values)|-8.34|STANDARD_DEVIATION|18.34||0.056|TWO_SIDED||||||t-test, 2 sided|||Paired t-test on VAS scores during speech comparing sublingual riluzole to placebo||||0.056
73934070|NCT02114892|147398175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
73934071|NCT02114892|147398176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
73972273|NCT05828017|147485337|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.357|TWO_SIDED|95.0|0.0|1.0|||ANOVA|||This is to see if there is a difference in SRT 50 scores between the standard curve and variation #1.||1|0|0.357
73972274|NCT05828017|147485338|SUPERIORITY||Total Count - Cramer's V|0.7|||<|0.01|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2, #3, and #4||||<0.01
73934072|NCT02114892|147398177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.070
73934073|NCT02114892|147398178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.338|||||||Wilcoxon (Mann-Whitney)|||||||0.338
73934074|NCT02114892|147398179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||||||0.278
73934075|NCT02114892|147398180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73972275|NCT05828017|147485338|SUPERIORITY||Total Count - Cramer's V|0.01||||0.94|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2 and #3.||||0.94
73934076|NCT02114892|147398181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083|||||||Wilcoxon (Mann-Whitney)|||||||0.083
73934077|NCT02114892|147398182|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73972276|NCT05828017|147485338|SUPERIORITY||Total Count - Cramer's V|0.014||||0.94|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2 and #4||||0.94
74030431|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|1.61||||0.002|TWO_SIDED|95.0|1.19|2.17||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Hormonal IUD does not affect fertility||2.17|1.19|0.002
73934078|NCT02114892|147398183|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73934079|NCT02114892|147398184|SUPERIORITY_OR_OTHER_LEGACY|||||||0.946|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.946
73934080|NCT02114892|147398185|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.365
73934081|NCT02114892|147398186|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.557
73972277|NCT05828017|147485338|SUPERIORITY||Total Count - Cramer's V|0.45||||0.017|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2, #3, and #4||||0.017
73972278|NCT05828017|147485338|SUPERIORITY||Total Count - Cramer's V|0.51||||0.02|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #3.||||0.02
73934082|NCT02114892|147398187|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73934083|NCT02114892|147398188|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73934084|NCT02114892|147398189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||0.672
73934085|NCT02660944|147398213|SUPERIORITY|Two-sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|0.37||||0.845|TWO_SIDED|95.0|-3.42|4.15|||t-test, 2 sided|||Change from baseline at Day 85 RSLV-132 versus placebo||4.15|-3.42|0.845
73934086|NCT02660944|147398213|SUPERIORITY|Two-sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|-0.48||||0.818|TWO_SIDED|95.0|-4.66|3.7|||t-test, 2 sided|||Change from baseline at Day 169 RSLV-132 versus placebo||3.70|-4.66|0.818
73934087|NCT03586999|147398217|SUPERIORITY||proportion|0.3||||0.1|TWO_SIDED|90.0||||The proportion achieving a complete response will be calculated and will compared to null proportion of 30%. The population proportion for complete response rate, p-value and 90% confidence intervals for the complete response rate will be calculated.|t-test, 2 sided|||The study was to be suspended, if, at any time, there was sufficient evidence to suggest that the true probability of achieving a complete response falls below 30% while assuming the treatment drug will elicit a 56% complete response rate. Statistically significant evidence for this low complete response rate is defined as an observed complete response rate whose upper one-sided 90% confidence limit is 0-30%. Sample size calculations were made assuming 80% power.||||.1
73934088|NCT04096560|147398227|SUPERIORITY||LS Mean Difference|26.4|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|20.07|32.73||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||32.73|20.07|<0.001
73934089|NCT04096560|147398227|SUPERIORITY||LS Mean Difference|29.9|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|23.68|36.07||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||36.07|23.68|<0.001
73934090|NCT04096560|147398227|SUPERIORITY||LS Mean Difference|35.0|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|28.73|41.34||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||41.34|28.73|<0.001
73934091|NCT04096560|147398234|SUPERIORITY||LS Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-14.07|-6.16||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-6.16|-14.07|<0.001
73934092|NCT04096560|147398234|SUPERIORITY||LS Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-15.2|-7.56||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-7.56|-15.20|<0.001
73972279|NCT05828017|147485338|SUPERIORITY||Total Count - Cramer's V|0.61||||0.006|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #4||||0.006
73972280|NCT05828017|147485338|SUPERIORITY||Total Count - Cramer's V|0.6|||<|0.0001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2, #3, and #4||||<.0001
73972281|NCT05828017|147485338|SUPERIORITY||Total Count - Cramer's V|0.38||||0.08|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2 and #3||||0.08
73972282|NCT05828017|147485338|SUPERIORITY||Total Count - Cramer's V|0.5|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2 and #4||||<0.001
73972283|NCT06149338|147485348|SUPERIORITY|||||||0.0002||||||Threshold for statistical significance: p \< 0.05|Chi-squared|||||||0.0002
73972284|NCT06149338|147485348|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
73972285|NCT06149338|147485349|SUPERIORITY||||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Kruskal-Wallis|||||||< 0.0001
73972286|NCT06149338|147485350|SUPERIORITY|||||||0.0041||||||Threshold for statistical significance: p \< 0.05|Chi-squared|||||||0.0041
73972287|NCT06149338|147485350|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74091654|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|6.93|||||TWO_SIDED|95.0|4.45|10.8|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 35B||10.80|4.45|
73934093|NCT04096560|147398234|SUPERIORITY||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-16.96|-9.09||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-9.09|-16.96|<0.001
73934094|NCT04096560|147398235|SUPERIORITY||IRR|0.05|||=|0.002|TWO_SIDED|95.0|0.007|0.317||The incidence rate was the exponentiated LS means and the incidence rate ratio (IRR) was the exponentiated LS mean differences from the generalized estimating equation (GEE) Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.317|0.007|=0.002
73934095|NCT04096560|147398235|SUPERIORITY||IRR|0.2|||=|0.019|TWO_SIDED|95.0|0.05|0.767||The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.767|0.050|=0.019
73934096|NCT04096560|147398235|SUPERIORITY||IRR|0.15|||=|0.001|TWO_SIDED|95.0|0.047|0.482||The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.482|0.047|=0.001
73934097|NCT01485861|147398243|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.77||||0.1606|TWO_SIDED|90.0|0.56|1.04|||Log Rank|||||1.04|0.56|0.1606
73972288|NCT06149338|147485351|SUPERIORITY|||||||0.7895||||||Threshold for statistical significance: p \< 0.05|Kruskal-Wallis|||||||0.7895
73972289|NCT02398656|147485436|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.88|1.04||||||||1.04|0.88|
73972290|NCT02038777|147485450|OTHER||||||<|0.0001||||||An exact test for a single proportion (1-sided significance level: 0.05) was used.|Exact test for a single proportion|||||||<.0001
73972291|NCT04299464|147485523|SUPERIORITY||Difference in Adjusted Mean|-0.432||||0.765|TWO_SIDED|80.0|-2.291|1.428|||ANCOVA|||||1.428|-2.291|0.7650
73865670|NCT00129961|147277322|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC In Situ||||0.012
73934098|NCT01485861|147398243|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.89||||0.53|TWO_SIDED|90.0|0.66|1.2|||Log Rank|||||1.20|0.66|0.5300
73972292|NCT04299464|147485523|SUPERIORITY||Difference in Adjusted Mean|-0.4444||||0.7517|TWO_SIDED|80.0|-2.25|1.363|||ANCOVA|||||1.363|-2.250|0.7517
73972293|NCT04299464|147485532|SUPERIORITY||Difference in Adjusted Mean|1.741||||0.6082|TWO_SIDED|80.0|-2.631|6.114|||ANCOVA|||||6.114|-2.631|0.6082
73972294|NCT04299464|147485532|SUPERIORITY||Difference in Adjusted Mean|-1.715||||0.6228|TWO_SIDED|80.0|-6.204|2.774|||ANCOVA|||||2.774|-6.204|0.6228
73972295|NCT04299464|147485533|SUPERIORITY||Difference in Adjusted Mean|-2.983||||0.1987|TWO_SIDED|80.0|-5.957|-0.009|||ANCOVA|||||-0.009|-5.957|0.1987
73972296|NCT04299464|147485533|SUPERIORITY||Difference in Adjusted Mean|-4.474||||0.046|TWO_SIDED|80.0|-7.326|-1.622|||ANCOVA|||||-1.622|-7.326|0.0460
73972297|NCT04299464|147485534|SUPERIORITY||Difference in Adjusted Means|1.279||||0.4746|TWO_SIDED|80.0|-1.021|3.578|||ANCOVA|||||3.578|-1.021|0.4746
73972298|NCT04299464|147485534|SUPERIORITY||Difference in Adjusted Means|2.697||||0.1244|TWO_SIDED|80.0|0.453|4.94|||ANCOVA|||||4.940|0.453|0.1244
73972299|NCT03676192|147485535|EQUIVALENCE|The similarity criterion had been set such that the confidence limits of the 95% confidence interval (CI) of the difference of ORR from each treatment group was entirely bounded by the interval (-12.5, 12.5).|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-7.02|7.83||||||Logistic regression model including treatment groups (CT-P16 and EU-approved Avastin) as a fixed effect and region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as covariates was used.||7.83|-7.02|
73972300|NCT03676192|147485535|EQUIVALENCE|The similarity criterion had been set such that the confidence limits of the 90% confidence interval (CI) of the ratio of ORR from each treatment group was entirely bounded by the interval (0.7368, 1.3572).|Risk Ratio (RR)|1.0136|||||TWO_SIDED|90.0|0.8767|1.1719||||||Log-binomial regression model including treatment groups (CT-P16 and EU-approved Avastin) as a fixed effect and region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as covariates was used.||1.1719|0.8767|
73972301|NCT03676192|147485538|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.1||||||Adjusted stratified Cox regression model is used to estimate the hazard ratio and its 95% CI for receiving CT-P16 compared with receiving EU-approved Avastin using region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as stratification factors.||1.10|0.77|
73972302|NCT03676192|147485539|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.77|1.19||||||Adjusted stratified Cox regression model is used to estimate the hazard ratio and its 95% CI for receiving CT-P16 compared with receiving EU-approved Avastin using region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as stratification factors.||1.19|0.77|
73972303|NCT01868997|147485595|SUPERIORITY||Odds Ratio (OR)|8.86|||<|0.001|TWO_SIDED|95.0|3.293|23.825||Odds ratio, 95% confidence interval, and P-value are obtained from a logistic regression model with treatment and smoking status as covariates.|Regression, Logistic|||||23.825|3.293|< 0.001
73972304|NCT01868997|147485596|SUPERIORITY||Difference in Least Squares Mean|10.97|STANDARD_ERROR_OF_MEAN|3.221||0.001|TWO_SIDED|95.0|4.561|17.375|||Mixed-Model Repeated Measures|||||17.375|4.561|0.001
73934099|NCT01485861|147398243|SUPERIORITY|Strata are: prior enzalutamide (Yes vs. No), progression factor (prostate-specific antigen \[PSA\] only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).|Hazard Ratio (HR)|0.75||||0.1689|TWO_SIDED|90.0|0.54|1.05|||Log Rank|||||1.05|0.54|0.1689
73934100|NCT01485861|147398243|SUPERIORITY|Strata are: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).|Hazard Ratio (HR)|0.94||||0.7484|TWO_SIDED|90.0|0.69|1.28|||Log Rank|||||1.28|0.69|0.7484
73934101|NCT01485861|147398244|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.39||||0.0064|TWO_SIDED|90.0|0.22|0.7|||Log Rank|||||0.70|0.22|0.0064
73934102|NCT01485861|147398244|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.46||||0.0285|TWO_SIDED|90.0|0.25|0.83|||Log Rank|||||0.83|0.25|0.0285
73972305|NCT01868997|147485597|SUPERIORITY||Difference in Least Squares Mean|-2.31|STANDARD_ERROR_OF_MEAN|0.269|<|0.001|TWO_SIDED|95.0|-2.843|-1.772|||Mixed-Model Repeated Measures|||||-1.772|-2.843|< 0.001
73865671|NCT00129961|147277322|SUPERIORITY_OR_OTHER|||||||0.463||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive with Perineural Invasion||||0.463
73865672|NCT00129961|147277322|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive without Perineural Invasion||||0.004
73865673|NCT00129961|147277322|SUPERIORITY_OR_OTHER|||||||0.094||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Superficial||||0.094
73865674|NCT00129961|147277322|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Nodular||||0.720
73865675|NCT00129961|147277322|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Infiltrative||||0.227
73865676|NCT00129961|147277323|SUPERIORITY_OR_OTHER|||||||0.748||95.0|||||Poisson regression|||||||0.748
73865677|NCT00129961|147277324|SUPERIORITY_OR_OTHER|||||||0.425||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||||||0.425
73865678|NCT00129961|147277327|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||||||0.604
73865679|NCT00129961|147277328|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||ANCOVA|||||||0.672
73865680|NCT00129961|147277329|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Fisher Exact|||||||0.999
73865681|NCT00129961|147277330|SUPERIORITY_OR_OTHER|||||||0.588||95.0|||||Fisher Exact|||||||0.588
73865682|NCT00129961|147277331|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Fisher Exact|||||||0.999
73865683|NCT00129961|147277332|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.030
73865684|NCT04407234|147277361|SUPERIORITY||Ratio of geometric least squares mean|0.881|||||TWO_SIDED|90.0|0.803|0.967|||Wilcoxon signed rank test|||||0.967|0.803|
73865685|NCT04407234|147277361|SUPERIORITY||Ratio of geometric least squares mean|1.16|||||TWO_SIDED|90.0|1.05|1.28|||Wilcoxon signed rank test|||||1.28|1.05|
73865686|NCT04407234|147277362|SUPERIORITY||Ratio of geometric least squares mean|0.446|||||TWO_SIDED|90.0|0.39|0.509|||Wilcoxon signed rank test|||||0.509|0.390|
73865687|NCT04407234|147277362|SUPERIORITY||Ratio of geometric least squares mean|0.679|||||TWO_SIDED|90.0|0.589|0.783|||Wilcoxon signed rank test|||||0.783|0.589|
73865688|NCT04407234|147277364|SUPERIORITY||Ratio of geometricleast squares mean|0.888|||||TWO_SIDED|90.0|0.778|1.01||||||||1.01|0.778|
73865689|NCT04407234|147277364|SUPERIORITY||Ratio of geometricleast squares mean|1.23|||||TWO_SIDED|90.0|1.07|1.42||||||||1.42|1.07|
73865690|NCT04407234|147277365|SUPERIORITY||Ratio of geometricleast squares mean|0.875|||||TWO_SIDED|90.0|0.766|0.999||||||||0.999|0.766|
73865691|NCT04407234|147277365|SUPERIORITY||Ratio of geometricleast squares mean|1.08|||||TWO_SIDED|90.0|0.938|1.25||||||||1.25|0.938|
73865692|NCT04407234|147277366|SUPERIORITY||Ratio of geometricleast squares mean|0.453|||||TWO_SIDED|90.0|0.376|0.545||||||||0.545|0.376|
73865693|NCT04407234|147277366|SUPERIORITY||Ratio of geometricleast squares mean|0.804|||||TWO_SIDED|90.0|0.66|0.979||||||||0.979|0.660|
73865694|NCT04407234|147277367|SUPERIORITY||Ratio of geometricleast squares mean|0.438|||||TWO_SIDED|90.0|0.364|0.527||||||||0.527|0.364|
73865695|NCT04407234|147277367|SUPERIORITY||Ratio of geometricleast squares mean|0.574|||||TWO_SIDED|90.0|0.471|0.698||||||||0.698|0.471|
73865696|NCT00727558|147277368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.554|STANDARD_ERROR_OF_MEAN|0.1943||||97.47|0.1721|0.554|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.554|0.1721|
73865697|NCT00727558|147277369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1734|STANDARD_ERROR_OF_MEAN|0.03555||||97.47|-0.1734|-0.1037|||Mixed Models Analysis||Mean difference is narafilcon A minus nelfilcon A|Alternative hypothesis: narafilcon A is superior to nelfilcon A.||-0.1037|-0.1734|
73865698|NCT00727558|147277370|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3968|STANDARD_ERROR_OF_MEAN|0.1548||||98.7|0.04983|0.3968|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.3968|0.04983|
73934103|NCT01485861|147398262|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.87||||0.417|TWO_SIDED|95.0|0.62|1.22|||Log Rank|||||1.22|0.62|0.4170
73934104|NCT01485861|147398262|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.93||||0.6712|TWO_SIDED|95.0|0.67|1.3|||Log Rank|||||1.30|0.67|0.6712
73934105|NCT01485861|147398262|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.5164|TWO_SIDED|95.0|0.62|1.27|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.27|0.62|0.5164
73934106|NCT01485861|147398262|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8955|TWO_SIDED|95.0|0.72|1.44|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.44|0.72|0.8955
73972306|NCT01868997|147485598|SUPERIORITY||Difference in Least Squares Mean|-1.59|STANDARD_ERROR_OF_MEAN|0.245|<|0.001|TWO_SIDED|95.0|-2.073|-1.098|||Mixed-Model Repeated Measures|||||-1.098|-2.073|< 0.001
73972307|NCT01868997|147485599|SUPERIORITY||Difference in Least Squares Mean|14.16|STANDARD_ERROR_OF_MEAN|3.827|<|0.001|TWO_SIDED|95.0|6.549|21.773|||Mixed-Model Repeated Measures|||||21.773|6.549|< 0.001
73972308|NCT01868997|147485600|SUPERIORITY||Difference in Least Squares Mean|6.32|STANDARD_ERROR_OF_MEAN|3.81||0.101|TWO_SIDED|95.0|-1.255|13.901|||Mixed-Model Repeated Measures|||||13.901|-1.255|0.101
73972309|NCT01960452|147485601|OTHER|Group comparison, for absolute (spatially z-score normalized across all electrodes for each subject)||||||0.2791|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.2791
73972310|NCT01960452|147485601|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.9|||||||t-test, 2 sided|||||||0.9
73972311|NCT01960452|147485602|OTHER|Group comparison, for both absolute (spatially z-score normalized across all electrodes for each subject)||||||0.1069|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.1069
73972312|NCT01960452|147485602|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.546|||||||t-test, 2 sided|||||||0.546
73972313|NCT01960452|147485603|OTHER|Group comparison, for absolute (spatially z-score normalized across all electrodes for each subject)||||||0.2918|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.2918
73972314|NCT01960452|147485603|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.761|||||||t-test, 2 sided|||||||0.761
74030432|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|1.56||||0.004|TWO_SIDED|95.0|1.15|2.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Non-hormonal IUD does not affect fertility||2.1|1.15|0.004
73865699|NCT00727558|147277371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3875|STANDARD_ERROR_OF_MEAN|0.2054||||98.7|0.03714|0.3875|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A.||0.3875|0.03714|
73865700|NCT00727558|147277372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6735|STANDARD_ERROR_OF_MEAN|0.1563||||98.7|0.213|0.6735|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.6735|0.213|
73865701|NCT00727558|147277373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.1648||||98.7|-0.2375|0.132|||Mixed Models Analysis||Mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.132|-0.2375|
73972315|NCT03916276|147485615|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce a greater proportion of people decreasing their dose relative to those increasing their dose during treatment.|||||>|0.05|||||||Chi-squared|||||||>.05
73972316|NCT03916276|147485616|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972317|NCT03916276|147485617|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972318|NCT03916276|147485618|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972319|NCT03916276|147485619|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972320|NCT03916276|147485620|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972321|NCT03916276|147485621|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972322|NCT03916276|147485622|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972323|NCT03916276|147485623|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972324|NCT03916276|147485624|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||<|0.05|||||||ANOVA|||||||<.05
73972325|NCT03916276|147485625|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements|||||>|0.05|||||||ANOVA|||||||>.05
73972326|NCT03916276|147485626|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements|||||>|0.05|||||||ANOVA|||||||>.05
73972327|NCT03916276|147485627|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972328|NCT03916276|147485628|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972329|NCT03916276|147485629|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972330|NCT03916276|147485630|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972331|NCT03916276|147485631|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972332|NCT03209973|147485632|OTHER||||||<|0.0001||||||1-sided p-value was based on exact test of BGB-A317 versus historical rate of 0.35|Exact Binomial Test|Comparison with historical control values||||||<0.0001
73934107|NCT01485861|147398263|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.63||||0.1472|TWO_SIDED|95.0|0.33|1.19|||Log Rank|||||1.19|0.33|0.1472
73934108|NCT01485861|147398263|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.45||||0.0157|TWO_SIDED|95.0|0.23|0.87|||Log Rank|||||0.87|0.23|0.0157
73934109|NCT01485861|147398266|SUPERIORITY||Hazard Ratio (HR)|0.7|||=|0.0665|TWO_SIDED|90.0|0.51|0.97|||Log Rank|||||0.97|0.51|= 0.0665
73972333|NCT04778397|147485648|SUPERIORITY||Stratified Hazard Ratio|1.132||||0.507|TWO_SIDED|95.0|0.783|1.637|||Stratified log-rank test|P-value from stratified log-rank test.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors (appropriateness for non-intensive therapy vs intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites)).|1.637|0.783|0.5070
73972334|NCT04778397|147485649|SUPERIORITY||Stratified Hazard Ratio|1.183||||0.3237|TWO_SIDED|95.0|0.845|1.654|||Stratified Log-rank test|P-value from stratified log-rank test.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors (appropriateness for non-intensive therapy vs intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites)).|1.654|0.845|0.3237
73972335|NCT04778397|147485650|SUPERIORITY||Stratified Hazard Ratio|1.389||||0.0661|TWO_SIDED|95.0|1.043|1.848|||Stratified Log-rank test|P-value for comparing the event free survival functions from the two treatment groups was from stratified log-rank test, adjusted for randomization.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors: therapy appropriateness, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites).|1.848|1.043|0.0661
73972336|NCT04778397|147485651|SUPERIORITY||Stratified Odds Ratio|0.25|||||TWO_SIDED|95.0|0.123|0.506|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.506|0.123|
74030433|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|1.54||||0.005|TWO_SIDED|95.0|1.14|2.07||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Implant does not affect fertility||2.07|1.14|0.005
73934110|NCT01485861|147398266|SUPERIORITY||Hazard Ratio (HR)|0.99|||=|0.9319|TWO_SIDED|90.0|0.73|1.33|||Log Rank|||||1.33|0.73|= 0.9319
73934111|NCT01485861|147398266|SUPERIORITY||Hazard Ratio (HR)|0.7|||=|0.071|TWO_SIDED|90.0|0.5|0.97|||Log Rank|||Strata were: prior Enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||0.97|0.50|= 0.0710
73934112|NCT01485861|147398266|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.789|TWO_SIDED|90.0|0.7|1.31|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.31|0.70|= 0.7890
73934113|NCT01485861|147398267|SUPERIORITY||Hazard Ratio (HR)|0.68|||=|0.2906|TWO_SIDED|90.0|0.37|1.25|||Log Rank|||||1.25|0.37|= 0.2906
73934114|NCT01485861|147398267|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.2716|TWO_SIDED|90.0|0.35|1.22|||Log Rank|||||1.22|0.35|= 0.2716
74030434|NCT02078713|147615159|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.75|3.49||P-value calculated in multiply imputed dataset.|Regression, Logistic||OR calculated in multiply imputed dataset. Intervention patients had 2.47 times the odds of control patients to give correct answer.|Comparison of correct knowledge - composite IUD knowledge item (all correct responses on items related to IUD knowledge, versus any incorrect)||3.49|1.75|<0.0001
73934115|NCT01485861|147398268|SUPERIORITY|Unstratified|Difference in response rates|1.97|||=|0.7913|TWO_SIDED|90.0|-10.25|14.18|||Chi-squared|||||14.18|-10.25|= 0.7913
73934116|NCT01485861|147398268|SUPERIORITY|Unstratified|Difference in response rates|-1.22|||=|0.8675|TWO_SIDED|90.0|-13.24|10.8|||Chi-squared|||||10.80|-13.24|= 0.8675
73934117|NCT01485861|147398269|SUPERIORITY||Difference in response rates|11.43|||=|0.4176|TWO_SIDED|90.0|-11.43|58.32|||Chi-squared|||||58.32|-11.43|= 0.4176
73934118|NCT01485861|147398269|SUPERIORITY||Difference in response rates|15.43|||=|0.2802|TWO_SIDED|90.0|-7.58|38.44|||Chi-squared|||||38.44|-7.58|= 0.2802
73934119|NCT01485861|147398270|SUPERIORITY||Difference in response rates|9.58|||=|0.3646|TWO_SIDED|90.0|-7.65|26.8|||Chi-squared|||||26.80|-7.65|= 0.3646
73934120|NCT01485861|147398270|SUPERIORITY||Difference in response rates|0.22|||=|0.9821|TWO_SIDED|90.0|-15.89|16.33|||Chi-squared|||||16.33|-15.89|= 0.9821
73934121|NCT01485861|147398271|SUPERIORITY||Difference in response rates|-3.17|||=|0.8489|TWO_SIDED|90.0|-30.93|24.58|||Chi-squared|||||24.58|-30.93|= 0.8489
73934122|NCT01485861|147398271|SUPERIORITY||Difference in response rates|12.38|||=|0.5186|TWO_SIDED|90.0|-16.36|41.12|||Chi-squared|||||41.12|-16.36|= 0.5186
73934123|NCT01485861|147398272|SUPERIORITY|Unstratified|Hazard Ratio (HR)|1.31|||=|0.678|TWO_SIDED|90.0|0.45|3.8|||Log Rank|||||3.80|0.45|= 0.6780
73934124|NCT01485861|147398272|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.85|||=|0.8372|TWO_SIDED|90.0|0.24|3.02|||Log Rank|||||3.02|0.24|= 0.8372
73934125|NCT01485861|147398272|SUPERIORITY||Hazard Ratio (HR)|0.77|||=|0.7733|TWO_SIDED|90.0|0.17|3.5|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||3.50|0.17|= 0.7733
73972337|NCT04778397|147485652|SUPERIORITY||Stratified Odds Ratio|0.072|||||TWO_SIDED|95.0|0.009|0.559|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.559|0.009|
73972338|NCT04778397|147485653|SUPERIORITY||Stratified Odds Ratio|0.215|||||TWO_SIDED|95.0|0.108|0.428|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.428|0.108|
73972339|NCT04359654|147485676|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
73972340|NCT04359654|147485677|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
73865702|NCT00727558|147277374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2469|STANDARD_ERROR_OF_MEAN|0.04448||||97.47|-0.2469|-0.1599|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A by having a lower level of inferior region corneal staining||-0.1599|-0.2469|
73865703|NCT01754493|147277375|SUPERIORITY_OR_OTHER_LEGACY||Slope|-18.24|||<|0.05|TWO_SIDED|95.0|-23.44|-12.63|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total MADRS symptom scores for MDD. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-12.63|-23.44|<.05
73865704|NCT01754493|147277376|SUPERIORITY_OR_OTHER_LEGACY||Slope|-20.71|||<|0.05|TWO_SIDED|95.0|-27.44|-13.97|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total GSRS symptom scores for IBS. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-13.97|-27.44|<0.05
73934126|NCT01485861|147398272|SUPERIORITY||Hazard Ratio (HR)|2.46|||=|0.4227|TWO_SIDED|90.0|0.36|16.59|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||16.59|0.36|= 0.4227
73934127|NCT01485861|147398273|SUPERIORITY||Hazard Ratio (HR)|999.99|||=|0.3173|TWO_SIDED|90.0|0.0||NA = Not estimable due to limited number of events observed||Log Rank||\>||||0.00|= 0.3173
73934128|NCT01485861|147398273|SUPERIORITY||Hazard Ratio (HR)|999.99|||=|0.6171|TWO_SIDED|90.0|0.0||NA = Not estimable due to limited number of events observed||Log Rank||\>||||0.00|= 0.6171
73934129|NCT01485861|147398274|SUPERIORITY||Difference in response rates|3.75|||=|0.6652|TWO_SIDED|90.0|-10.47|17.97|||Chi-squared|||||17.97|-10.47|= 0.6652
73934130|NCT01485861|147398274|SUPERIORITY||Difference in response rates|7.48|||=|0.3734|TWO_SIDED|90.0|-6.29|21.24|||Chi-squared|||||21.24|-6.29|= 0.3734
73865705|NCT01754493|147277377|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.59|||<|0.05|TWO_SIDED|95.0|-2.16|-1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-MDD score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.03|-2.16|<0.05
73934131|NCT01485861|147398275|SUPERIORITY||Difference in response rates|4.41|||=|0.7633|TWO_SIDED|90.0|-19.76|28.58|||Chi-squared|||||28.58|-19.76|= 0.7633
73865706|NCT01754493|147277377|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.55|||<|0.05|TWO_SIDED|95.0|-1.99|-1.11|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-IBS score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.11|-1.99|<0.05
73865707|NCT01754493|147277378|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.03|||<|0.05|TWO_SIDED|95.0|-1.16|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of overall pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.10|-1.16|<0.05
73865708|NCT01754493|147277378|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.47|||<|0.05|TWO_SIDED|95.0|-1.07|2.01|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This repeated-measures mixed-effects regression analysis assessed the rate of change in VAS score of pain interfering with daily activities. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a 1st-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis||2.01|-1.07|<0.05
73934132|NCT01485861|147398275|SUPERIORITY||Difference in response rates|4.41|||=|0.7633|TWO_SIDED|90.0|-19.76|28.58|||Chi-squared|||||28.58|-19.76|= 0.7633
73934133|NCT01485861|147398276|SUPERIORITY||Difference in response rates|2.24|||=|0.8317|TWO_SIDED|90.0|-15.07|19.54|||Chi-squared|||||19.54|-15.07|= 0.8317
73934134|NCT01485861|147398276|SUPERIORITY||Difference in response rates|5.14|||=|0.6139|TWO_SIDED|90.0|-11.6|21.88|||Chi-squared|||||21.88|-11.60|= 0.6139
73934135|NCT01485861|147398277|SUPERIORITY||Difference in response rates|34.85|||=|0.0505|TWO_SIDED|90.0|7.14|62.56|||Chi-squared|||||62.56|7.14|= 0.0505
73934136|NCT01485861|147398277|SUPERIORITY||Difference in response rates|-9.6|||=|0.4989|TWO_SIDED|90.0|-32.54|13.35|||Chi-squared|||||13.35|-32.54|= 0.4989
73934137|NCT01485861|147398280|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.95|||=|0.8483|TWO_SIDED|90.0|0.61|1.47|||Log Rank|||||1.47|0.61|= 0.8483
73934138|NCT01485861|147398280|SUPERIORITY|Unstratified|Hazard Ratio (HR)|1.08|||=|0.785|TWO_SIDED|90.0|0.7|1.65|||Log Rank|||||1.65|0.70|= 0.7850
73934139|NCT01485861|147398280|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.8847|TWO_SIDED|90.0|0.66|1.65|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.65|0.66|= 0.8847
73934140|NCT01485861|147398280|SUPERIORITY||Hazard Ratio (HR)|1.05|||=|0.8647|TWO_SIDED|90.0|0.67|1.63|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.63|0.67|= 0.8647
73934141|NCT01485861|147398281|SUPERIORITY||Hazard Ratio (HR)|0.89|||=|0.8271|TWO_SIDED|90.0|0.39|2.06|||Log Rank|||||2.06|0.39|= 0.8271
73934142|NCT01485861|147398281|SUPERIORITY||Hazard Ratio (HR)|0.84|||=|0.7383|TWO_SIDED|90.0|0.35|2.02|||Log Rank|||||2.02|0.35|= 0.7383
73972341|NCT04359654|147485679|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
73934143|NCT01731171|147398343|OTHER|The effect of treatment was calculated using logistic regression and the Cox proportional hazard function employing age, gender, and race as covariates.|Cox Proportional Hazard|0.37|||=|0.029|TWO_SIDED|95.0|||||Regression, Logistic||Values less than one favor adjunctive probiotic treatment, while values higher than one favor the placebo.|||||=.029
73934144|NCT01731171|147398344|SUPERIORITY||||||=|0.022|||||||Chi-squared|||||||=.022
73865709|NCT01754493|147277378|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.59|||<|0.05|TWO_SIDED|95.0|-2.28|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of headaches. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.10|-2.28|<0.05
73934145|NCT01731171|147398345|SUPERIORITY||||||=|0.009|||||||Regression, Linear|||||||=.009
73934146|NCT01731171|147398346|SUPERIORITY||||||=|0.017|||||||Kruskal-Wallis|||||||=.017
73934147|NCT01736852|147398348|NON_INFERIORITY|non-inferiority margin of 10%, α = 0.025, power = 0.80,||||||0.06|||||||Fisher Exact|||.ample size calculations were performed using an expected rate of 4% for each group,a one-sided exact test, α = 0.025, power = 0.80, non-inferiority margin of 10% resulting in a sample size of 124 patients or 62 patients per treatment arm.||||0.06
73934148|NCT00403546|147398354|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-1.09|1.12|||Mixed Models Analysis|||At Baseline||1.12|-1.09|0.980
73934149|NCT00403546|147398354|SUPERIORITY||Mean Difference (Net)|1.02||||0.033|TWO_SIDED|95.0|0.08|1.95|||Mixed Models Analysis|||At Week 2||1.95|0.08|0.033
73934150|NCT00403546|147398354|SUPERIORITY||Mean Difference (Net)|0.73||||0.171|TWO_SIDED|95.0|-0.32|1.77|||Mixed Models Analysis|||At Week 4||1.77|-0.32|0.171
73934151|NCT00403546|147398354|SUPERIORITY||Mean Difference (Net)|0.5||||0.38|TWO_SIDED|95.0|-0.62|1.62|||Mixed Models Analysis|||At Week 6||1.62|-0.62|0.380
73934152|NCT00403546|147398354|SUPERIORITY||Mean Difference (Net)|-0.12||||0.84|TWO_SIDED|95.0|-1.32|1.08|||Mixed Models Analysis|||At Week 8||1.08|-1.32|0.840
73934153|NCT00403546|147398355|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.737|TWO_SIDED|95.0|-1.23|0.88|||Mixed Models Analysis|||At Baseline||0.88|-1.23|0.737
73934154|NCT00403546|147398355|SUPERIORITY||Mean Difference (Net)|-0.14||||0.764|TWO_SIDED|95.0|-1.09|0.8|||Mixed Models Analysis|||At Week 2||0.80|-1.09|0.764
73934155|NCT00403546|147398355|SUPERIORITY||Mean Difference (Net)|0.25||||0.642|TWO_SIDED|95.0|-0.82|1.32|||Mixed Models Analysis|||At Week 4||1.32|-0.82|0.642
73934156|NCT00403546|147398355|SUPERIORITY||Mean Difference (Net)|-0.34||||0.57|TWO_SIDED|95.0|-1.5|0.83|||Mixed Models Analysis|||At Week 6||0.83|-1.50|0.570
73934157|NCT00403546|147398355|SUPERIORITY||Mean Difference (Net)|-0.09||||0.894|TWO_SIDED|95.0|-1.34|1.17|||Mixed Models Analysis|||At Week 8||1.17|-1.34|0.894
73934158|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|-1.82||||0.599|TWO_SIDED|95.0|-8.68|5.05|||Mixed Models Analysis|||SBP at Baseline||5.05|-8.68|0.599
73934159|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|3.53||||0.235|TWO_SIDED|95.0|-2.31|9.37|||Mixed Models Analysis|||SBP at Week 1||9.37|-2.31|0.235
73934160|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|2.83||||0.449|TWO_SIDED|95.0|-3.8|8.57|||Mixed Models Analysis|||SBP at Week 2||8.57|-3.80|0.449
73934161|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|3.64||||0.301|TWO_SIDED|95.0|-3.28|10.56|||Mixed Models Analysis|||SBP at Week 4||10.56|-3.28|0.301
73934162|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|-0.75||||0.842|TWO_SIDED|95.0|-8.13|6.63|||Mixed Models Analysis|||SBP at Week 6||6.63|-8.13|0.842
73934163|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|6.33||||0.109|TWO_SIDED|95.0|-1.43|14.09|||Mixed Models Analysis|||SBP at Week 8||14.09|-1.43|0.109
73934164|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|-0.8||||0.741|TWO_SIDED|95.0|-5.62|4.02|||Mixed Models Analysis|||DBP at Baseline||4.02|-5.62|0.741
73934165|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|1.44||||0.552|TWO_SIDED|95.0|-3.32|6.19|||Mixed Models Analysis|||DBP at Week 1||6.19|-3.32|0.552
73934166|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|2.83||||0.268|TWO_SIDED|95.0|-2.18|7.84|||Mixed Models Analysis|||DBP at Week 2||7.84|-2.18|0.268
73934167|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|1.02||||0.719|TWO_SIDED|95.0|-4.53|6.56|||Mixed Models Analysis|||DBP at Week 4||6.56|-4.53|0.719
73934168|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|-2.86||||0.334|TWO_SIDED|95.0|-8.68|2.96|||Mixed Models Analysis|||DBP at Week 6||2.96|-8.68|0.334
73934169|NCT00403546|147398357|SUPERIORITY||Mean Difference (Net)|4.38||||0.151|TWO_SIDED|95.0|-1.61|10.37|||Mixed Models Analysis|||DBP at Week 8||10.37|-1.61|0.151
73934170|NCT00403546|147398359|SUPERIORITY||Mean Difference (Final Values)|2.77||||0.416|TWO_SIDED|95.0|-3.97|9.5|||Mixed Models Analysis|Mixed models analysis with random slopes||At Baseline||9.50|-3.97|0.416
73934171|NCT00403546|147398359|SUPERIORITY||Mean Difference (Net)|0.37||||0.854|TWO_SIDED|95.0|-3.59|4.33|||Mixed Models Analysis|||At Week 2||4.33|-3.59|0.854
73934172|NCT00403546|147398359|SUPERIORITY||Mean Difference (Net)|1.95||||0.406|TWO_SIDED|95.0|-2.68|6.58|||Mixed Models Analysis|||At Week 4||6.58|-2.68|0.406
73934173|NCT00403546|147398359|SUPERIORITY||Mean Difference (Net)|-3.01||||0.256|TWO_SIDED|95.0|-8.23|2.21|||Mixed Models Analysis|||At Week 6||2.21|-8.23|0.256
73934174|NCT00403546|147398359|SUPERIORITY||Mean Difference (Net)|-1.37||||0.642|TWO_SIDED|95.0|-7.2|4.45|||Mixed Models Analysis|||At Week 8||4.45|-7.20|0.642
73934175|NCT00403546|147398361|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.135|TWO_SIDED|95.0|-1.55|0.2|||Mixed Models Analysis|||At Baseline||0.20|-1.55|0.135
73934176|NCT00403546|147398361|SUPERIORITY||Mean Difference (Net)|0.44||||0.262|TWO_SIDED|95.0|-0.33|1.21|||Mixed Models Analysis|||At Week 2||1.21|-0.33|0.262
73934177|NCT00403546|147398361|SUPERIORITY||Mean Difference (Net)|0.58||||0.209|TWO_SIDED|95.0|-0.33|1.49|||Mixed Models Analysis|||At Week 4||1.49|-0.33|0.209
73934178|NCT00403546|147398361|SUPERIORITY||Mean Difference (Net)|0.03||||0.95|TWO_SIDED|95.0|-1.01|1.07|||Mixed Models Analysis|||At Week 6||1.07|-1.01|0.950
73934179|NCT00403546|147398361|SUPERIORITY||Mean Difference (Net)|0.57||||0.34|TWO_SIDED|95.0|-0.61|1.76|||Mixed Models Analysis|||At Week 8||1.76|-0.61|0.340
73934180|NCT01700946|147398397|SUPERIORITY|||||||0.035|||||||Log Rank|||||||0.035
74030435|NCT02078713|147615160|SUPERIORITY||Odds Ratio (OR)|1.19||||0.25|TWO_SIDED|95.0|0.88|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at baseline||1.61|0.88|0.25
74039884|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.0573|TWO_SIDED|95.0|-0.63|0.01|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.63|0.0573
73865710|NCT01754493|147277378|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.35|||<|0.05|TWO_SIDED|95.0|-1.56|0.87|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of back pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||.87|-1.56|<0.05
73934181|NCT01700946|147398398|SUPERIORITY|||||||0.105|||||||Log Rank|||||||0.105
73934182|NCT01700946|147398399|SUPERIORITY|||||||0.1181|||||||Fisher Exact|||||||0.1181
73934183|NCT01168934|147398402|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|43.44|||||TWO_SIDED|90.0|39.68|47.56||||||Natural log transformed AUC (0 - ∞)(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||47.56|39.68|
73934184|NCT01168934|147398405|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|44.67|||||TWO_SIDED|90.0|40.9|48.78||||||Natural log transformed AUClast(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||48.78|40.90|
73934185|NCT01504438|147398420|OTHER|||||||0.29|||||||ANOVA|||||||0.29
73934186|NCT01504438|147398421|OTHER|||||||0.31|||||||ANOVA|||||||0.31
73934187|NCT01504438|147398422|OTHER|||||||0.07|||||||ANOVA|||||||0.07
73934188|NCT01504438|147398423|OTHER|||||||0.04|||||||ANOVA|||||||0.04
73934189|NCT01070810|147398426|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
73934190|NCT01070810|147398427|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.97|TWO_SIDED|95.0|0.61|1.62|||Regression, Cox|||Time to shock reversal was complicated by a high incidence of death prior to the event. To account for this we classified death as a competing risk event and used the estimated cumulative incidence function (CIF) to illustrate the comparison of CIFs between the two treatment groups using the Fine-Gray competing risk model. We tested the subdistribution hazards of these two CIF functions and obtained the estimated hazard ratio with 95% confidence intervals.||1.62|0.61|0.97
73934191|NCT01070810|147398428|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
73934192|NCT01070810|147398429|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73934193|NCT01070810|147398430|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
73934194|NCT05061446|147398452|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
73934195|NCT05061446|147398452|OTHER||Difference in percentage|26.3|||||TWO_SIDED|95.0|6.52|46.12||||||||46.12|6.52|
73934196|NCT05061446|147398453|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
73934197|NCT05061446|147398453|OTHER||Difference in percentage|26.3|||||TWO_SIDED|95.0|6.52|46.12||||||||46.12|6.52|
73934198|NCT05061446|147398454|OTHER||Difference in percentage|20.0|||||TWO_SIDED|95.0|-0.24|40.24||||||||40.24|-0.24|
73934199|NCT05061446|147398454|OTHER||Difference in percentage|31.6|||||TWO_SIDED|95.0|10.68|52.48||||||||52.48|10.68|
73934200|NCT05061446|147398455|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
73934201|NCT05061446|147398455|OTHER||Difference in percentage|5.3|||||TWO_SIDED|95.0|-4.78|15.3||||||||15.30|-4.78|
73934202|NCT05061446|147398456|OTHER||Difference in percentage|26.2|||||TWO_SIDED|95.0|-1.22|53.6||||||||53.60|-1.22|
73934203|NCT05061446|147398456|OTHER||Difference in percentage|45.5|||||TWO_SIDED|95.0|19.3|71.68||||||||71.68|19.30|
73934204|NCT03880578|147398459|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-14.9|-5.7|||Mixed Models Analysis|The outcome measure is change over time between treatment groups, reported as a mean adjusted difference.|change in the composite score of the ThyPRO between groups|||-5.7|-14.9|<0.001
73934205|NCT03880578|147398460|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.06|TWO_SIDED|95.0|-4.34|0.06|||Mixed Models Analysis|||||0.06|-4.34|0.06
73934206|NCT03880578|147398461|SUPERIORITY||Median Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|1.27|2.03|||Mixed Models Analysis||MAD obtained after log transformation of TSH|||2.03|1.27|<0.001
73934207|NCT03880578|147398462|SUPERIORITY||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.87|-0.35|||Mixed Models Analysis|||FT3||-0.35|-0.87|<0.001
73934208|NCT03880578|147398462|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.12|TWO_SIDED|95.0|-1.81|0.15|||Mixed Models Analysis|||FT4||0.15|-1.81|0.12
73934209|NCT03880578|147398463|SUPERIORITY||Mean Difference (Final Values)|-11.6|||<|0.001|TWO_SIDED|95.0|-14.6|-8.5|||Mixed Models Analysis|||||-8.5|-14.6|<0.001
73934210|NCT03149328|147398474|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates).||||||0.3||||||Threshold for statistical significance was p=0.05|ANCOVA|||We will examine the trajectories of outcome measures for patients in the comparator and intervention groups. The area under the curve (AUC) will be calculated for each trajectory during the period that the patient is participating to create a summary score. Null Hypothesis is that both groups are the same.||||0.30
73865711|NCT01754493|147277378|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.48|||<|0.05|TWO_SIDED|95.0|-2.0|1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of shoulder pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.03|-2.00|<0.05
73865712|NCT01754493|147277379|SUPERIORITY_OR_OTHER_LEGACY||Slope|-4.38|||<|0.05|TWO_SIDED|95.0|-7.39|-1.36|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in PHQ-15 scores of somatization symptoms. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.36|-7.39|<0.05
73865713|NCT01543776|147277380|NON_INFERIORITY|The above criteria for non-inferiority corresponds to a response rate in the low dose arm that is no more than 15% lower than the response rate in the high dose arm (i.e., non-inferiority margin of 15%), under the assumption that the log ratios are approximately normally distributed.|Mean Difference (Final Values)|0.3976|||<|0.1|ONE_SIDED|90.0|-0.1111|||Calculated p-value.|t-test, 1 sided||||||-0.1111|<0.10
73865714|NCT01543776|147277381|SUPERIORITY|||||||0.38|||||||Log Rank|||||||0.38
73865715|NCT01543776|147277382|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
73865716|NCT01543776|147277383|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.26
73865717|NCT01543776|147277384|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
73865718|NCT00568126|147277385|SUPERIORITY|Remission rates for maca vs. placebo were compared by chi-squared and by odds ratio (with 95% confidence interval).|Odds Ratio (OR)|2.1||||0.55|TWO_SIDED|95.0|0.18|25.2||P values above are calculated. No multiple comparisons. Threshold for significance set a priori as P\<0.05.|Chi-squared||Odds ratio for attaining remission while taking maca vs taking placebo|"Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX."||25.2|0.18|0.55
73865719|NCT00568126|147277386|SUPERIORITY|Remission rates for maca vs. placebo were compared by chi-squared and by odds ratio (with 95% confidence interval).|Odds Ratio (OR)|1.71||||0.47|TWO_SIDED|95.0|0.4|7.34||P values above are calculated. No multiple comparisons. Threshold for significance set a priori as P\<0.05.|Chi-squared||Odds ratio for attaining remission while taking maca vs taking placebo|"Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX."||7.34|0.40|0.47
73865720|NCT02421588|147277389|SUPERIORITY||Hazard Ratio (HR)|1.057||||0.6294|TWO_SIDED|95.0|0.854|1.309|||Log Rank|||PFS between treatments||1.309|0.854|0.6294
73865721|NCT02421588|147277389|SUPERIORITY||PFS at 6 months|24.3|||||TWO_SIDED|95.0|18.4|30.7|||||Percent of Participants|PFS (%) at 6 months||30.7|18.4|
73865722|NCT02421588|147277389|SUPERIORITY||PFS at 6 months|27.5|||||TWO_SIDED|95.0|20.9|34.4|||||Percent of Participants|PFS (%) at 6 months||34.4|20.9|
73865723|NCT02421588|147277389|SUPERIORITY|||||||0.5032|||||||Normal approximation|||PFS (%) at 6 months between treatments||||0.5032
73865724|NCT02421588|147277389|SUPERIORITY||PFS at 12 months|8.3|||||TWO_SIDED|95.0|4.7|13.3|||||Percent of Participants|PFS (%) at 12 months||13.3|4.7|
73865725|NCT02421588|147277389|SUPERIORITY||PFS at 12 months|7.0|||||TWO_SIDED|95.0|3.3|12.5|||||Percent of Participants|PFS (%) at 12 months||12.5|3.3|
73865726|NCT02421588|147277389|SUPERIORITY|||||||0.6742|||||||Normal approximation|||PFS (%) at 12 months between treatments||||0.6742
73865727|NCT02421588|147277390|SUPERIORITY||Hazard Ratio (HR)|0.987||||0.7673|TWO_SIDED|95.0|0.805|1.209|||Log Rank|||PFS between treatments||1.209|0.805|0.7673
73865728|NCT02421588|147277390|SUPERIORITY||PFS at 6 months|29.0|||||TWO_SIDED|95.0|22.8|35.4|||||Percent of Participants|PFS (%) at 6 months||35.4|22.8|
73865729|NCT02421588|147277390|SUPERIORITY||PFS at 6 months|27.4|||||TWO_SIDED|95.0|21.3|33.9|||||Percent of Participants|PFS (%) at 6 months||33.9|21.3|
73865730|NCT02421588|147277390|SUPERIORITY|||||||0.7385|||||||Normal approximation|||PFS (%) at 6 months between treatments||||0.7385
73865731|NCT02421588|147277390|SUPERIORITY||PFS (%) at 12 months|8.2|||||TWO_SIDED|95.0|4.8|12.7|||||Percent of Participants|PFS (%) at 12 months||12.7|4.8|
73865732|NCT02421588|147277390|SUPERIORITY||PFS (%) at 12 months|7.5|||||TWO_SIDED|95.0|4.2|12.2|||||Percent of Participants|PFS (%) at 12 months||12.2|4.2|
73865733|NCT02421588|147277390|SUPERIORITY|||||||0.8245|||||||Normal approximation|||PFS (%) at 12 months between treatments||||0.8245
73865734|NCT02421588|147277391|SUPERIORITY||Hazard Ratio (HR)|0.956||||0.8021|TWO_SIDED|95.0|0.772|1.183|||Log Rank|||OS between treatments||1.183|0.772|0.8021
73865735|NCT02421588|147277391|SUPERIORITY||OS at 12 months|48.2|||||TWO_SIDED|95.0|41.3|54.8|||||Percent of Participants|OS (%) at 12 months||54.8|41.3|
73865736|NCT02421588|147277391|SUPERIORITY||OS (%) at 12 months|45.3|||||TWO_SIDED|95.0|38.4|52.0|||||Percent of Participants|OS (%) at 12 months||52.0|38.4|
73865737|NCT02421588|147277391|SUPERIORITY|||||||0.5515|||||||Normal approximation|||OS (%) at 12 months between treatments||||0.5515
73934211|NCT03149328|147398475|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates).||||||0.28|||||||ANCOVA|||We will examine the trajectories of outcome measures for patients in the comparator and intervention groups. The area under the curve (AUC) will be calculated for each trajectory during the period that the patient is participating to create a summary score. Null Hypothesis = both groups are the same||||0.28
73972342|NCT04359654|147485680|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|||The reported LS means are antilogs of the LS means estimated on the log scale.||||0.021
73865738|NCT02421588|147277391|SUPERIORITY||OS (%) at 24 months|22.3|||||TWO_SIDED|95.0|16.8|28.2|||||Percent of Participants|OS (%) at 24 months||28.2|16.8|
73865739|NCT02421588|147277391|SUPERIORITY||OS (%) at 24 months|22.7|||||TWO_SIDED|95.0|17.1|28.7|||||Percent of Participants|OS (%) at 24 months||28.7|17.1|
73865740|NCT02421588|147277391|SUPERIORITY|||||||0.9253|||||||Normal approximation|||OS (%) at 24 months between treatments||||0.9253
73865741|NCT02421588|147277392|SUPERIORITY||ORR|14.5|||||TWO_SIDED|95.0|10.1|19.8|||||Percent of Participants|Overall response rate||19.8|10.1|
73865742|NCT02421588|147277392|SUPERIORITY||ORR|12.7|||||TWO_SIDED|95.0|8.6|17.8|||||Percent of Participants|Overall response rate||17.8|8.6|
73865743|NCT02421588|147277392|SUPERIORITY|||||||0.6772|||||||Fisher Exact|||Overall response rate between treatments||||0.6772
73865744|NCT02421588|147277393|SUPERIORITY||ORR|15.8|||||TWO_SIDED|95.0|11.3|21.3|||||Percent of Participants|Overall response rate (ORR)||21.3|11.3|
73865745|NCT02421588|147277393|SUPERIORITY||Overall response rate (ORR)|16.7|||||TWO_SIDED|95.0|12.1|22.3|||||Percent of Participants|Overall response rate (ORR)||22.3|12.1|
73865746|NCT02421588|147277393|SUPERIORITY|||||||0.8976|||||||Fisher Exact|||Overall response rate (ORR) between treatments||||0.8976
73865747|NCT02421588|147277394|SUPERIORITY||Hazard Ratio (HR)|1.406||||0.2631|TWO_SIDED|95.0|0.769|2.569|||Log Rank|||Duration of response between treatments||2.569|0.769|0.2631
73865748|NCT02421588|147277395|SUPERIORITY|Duration of response between treatments|Hazard Ratio (HR)|1.056||||0.8276|TWO_SIDED|95.0|0.64|1.743|||Log Rank|||||1.743|0.64|0.8276
73865749|NCT02421588|147277396|SUPERIORITY||ORR (%)|26.6|||||TWO_SIDED|95.0|20.2|33.8|||||Percent of Participants|ORR (%) by CA-125||33.8|20.2|
73865750|NCT02421588|147277396|SUPERIORITY||ORR (%)|19.4|||||TWO_SIDED|95.0|13.7|26.3|||||Percent of Participants|ORR (%) by CA-125||26.3|13.7|
73865751|NCT02421588|147277396|SUPERIORITY|||||||0.1231|||||||Fisher Exact|||ORR (%) by CA-125 between treatments||||0.1231
73865752|NCT04071158|147277427|SUPERIORITY||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.4|2.8||||||Difference in percentage||2.8|-1.4|
74008298|NCT03627767|147566493|SUPERIORITY||Difference in percentage|25.0|||<|0.0001|TWO_SIDED|95.0|18.4|31.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.5|18.4|< 0.0001
74030436|NCT02078713|147615160|SUPERIORITY||Odds Ratio (OR)|0.9||||0.5|TWO_SIDED|95.0|0.66|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention groups in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at 4 months post-enrollment||1.22|0.66|0.5
73865753|NCT04071158|147277428|SUPERIORITY||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-4.6|1.7||||||Difference in percentage||1.7|-4.6|
73865754|NCT04071158|147277429|SUPERIORITY||Ratio of Geometric Mean|0.8|||||TWO_SIDED|95.0|0.64|1.0||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||1.00|0.64|
73865755|NCT04071158|147277429|SUPERIORITY||Ratio of Geometric Mean|0.59|||||TWO_SIDED|95.0|0.5|0.7||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||0.70|0.50|
73865756|NCT04071158|147277429|SUPERIORITY||Ratio of Geometric Mean|0.6|||||TWO_SIDED|95.0|0.48|0.76||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||0.76|0.48|
73865757|NCT04071158|147277430|SUPERIORITY||Ratio of Geometric Mean|0.97|||||TWO_SIDED|95.0|0.84|1.13|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|2.0-fold margin (related to primary objective): primary objective was demonstrated if the lower limit of 95% confidence interval (CI) from the ratio of titers with 50 percent cut off from two treatment groups greater than (\>) 0.5.||1.13|0.84|
73865758|NCT04071158|147277431|SUPERIORITY||Ratio of Geometric Mean|0.96|||||TWO_SIDED|95.0|0.81|1.14|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|2.0-fold margin (related to primary objective): primary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.5.||1.14|0.81|
73865759|NCT04071158|147277436|SUPERIORITY||Ratio of Geometric Mean|0.97|||||TWO_SIDED|95.0|0.84|1.13|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|1.5-fold margin (related to secondary objective): secondary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.67.||1.13|0.84|
73865760|NCT04071158|147277437|SUPERIORITY||Ratio of Geometric Mean|0.96|||||TWO_SIDED|95.0|0.81|1.14|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|1.5-fold margin (related to secondary objective): secondary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.67.||1.14|0.81|
73865761|NCT00510744|147277455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|24.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||paired changes in fat absorption assessed by parametric (t test) or non-parametric tests (Mann-Whitney)||||<0.05
73865762|NCT02522442|147277493|OTHER|Pilot study, not powered for any endpoint.||||||0.377|||||||Chi-squared|||Pilot study, not powered for any endpoint.||||0.377
73865763|NCT02522442|147277494|OTHER|Pilot study, not powered for any endpoint.||||||0.624|||||||Chi-squared|||||||.624
73865764|NCT03836677|147277522|OTHER||Geometric Mean ratio to baseline|1.72|||<|0.0001|TWO_SIDED|95.0|1.38|2.13||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||2.13|1.38|<0.0001
74091655|NCT04168190|147737019|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|7.82|||||TWO_SIDED|95.0|5.0|12.24|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 35B||12.24|5.00|
73934212|NCT03149328|147398476|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.22||||||Threshold for statistical Significance was p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups in the number of hospitalizations"||||0.22
73934213|NCT03149328|147398476|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.1||||||Threshold for statistical Significance was p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups in the number of emergency room visits"||||0.10
73934214|NCT03149328|147398477|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.18||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||0.18
73934215|NCT03149328|147398478|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.79||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||0.79
73934216|NCT03149328|147398479|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)|||||<|0.001||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||<0.001
73865765|NCT03836677|147277522|OTHER||Geometric mean ratio to baseline|1.53|||<|0.0001|TWO_SIDED|95.0|1.28|1.83||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test.||||1.83|1.28|<0.0001
73865766|NCT03836677|147277523|OTHER||Geometric mean ratio to baseline|0.5|||<|0.0001|TWO_SIDED|95.0|0.39|0.63||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.63|0.39|<0.0001
73865767|NCT03836677|147277523|OTHER||Geometric mean ratio to baseline|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.67||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.67|0.40|<0.0001
73934217|NCT00019682|147398506|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.035
73934218|NCT00019682|147398507|SUPERIORITY|||||||0.008||||||Unadjusted 2 tail p value.|Log Rank|||||||0.008
73934219|NCT00019682|147398508|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
73934220|NCT00019682|147398509|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-G scale||||>0.05
73865768|NCT03836677|147277524|OTHER||Geometric mean ratio to baseline|1.7|||<|0.0001||95.0|1.37|2.11|||t-test, 2 sided|Within-group comparison to baseline using paired test||||2.11|1.37|<0.0001
73865769|NCT03836677|147277524|OTHER||Geometric mean ratio to baseline|1.51||||0.0001|TWO_SIDED|95.0|1.26|1.8|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.80|1.26|0.0001
73934221|NCT00019682|147398509|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-F scale||||>0.05
73934222|NCT00019682|147398509|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SF-36 scale||||>0.05
73934223|NCT00019682|147398509|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SDS scale||||>0.05
73934224|NCT03047447|147398544|OTHER|||||||0.001||||||Change over time from week 0 to week 10 with HgA1c for experimental ketogenic group vs.control exercise and non-exercise groups.|ANOVA|||||||0.001
73934225|NCT03047447|147398545|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with weight for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
73934226|NCT03047447|147398546|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with BMI for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
73934227|NCT03047447|147398547|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with body fat mass for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
73934228|NCT03047447|147398548|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with blood ketones for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
73934229|NCT00587587|147398598|SUPERIORITY_OR_OTHER|||||||1||||||"P-value compares overall incidence of AEs between groups, ie Apligraf 12/17 and Control 10/13.~UADE is defined in 21CFR812.3(s)"|Fisher Exact|||Fisher's exact test used to evaluate treatment differences between Apligraf subjects and Control subjects experiencing any AEs.||||1.0000
73934230|NCT00587587|147398599|SUPERIORITY_OR_OTHER|||||||0.5863||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5863
73934231|NCT00587587|147398600|SUPERIORITY_OR_OTHER|||||||0.3783||95.0|||||Fisher Exact|||||||0.3783
73934232|NCT00587587|147398601|SUPERIORITY_OR_OTHER|||||||0.7149|||||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar firmness evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.7149
73934233|NCT00587587|147398602|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar thickness evaluated using a 2-tailed Wilcoxon rank sum test||||0.1670
73934234|NCT00587587|147398603|SUPERIORITY_OR_OTHER|||||||0.7221|TWO_SIDED|0.0|||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.7221
74008299|NCT03627767|147566493|SUPERIORITY||Difference in percentage|39.6|||<|0.0001|TWO_SIDED|95.0|32.7|46.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.5|32.7|< 0.0001
73934235|NCT00587587|147398604|SUPERIORITY_OR_OTHER|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.4080
73934236|NCT00587587|147398605|SUPERIORITY_OR_OTHER|||||||0.9556||0.0|||||Wilcoxon (Mann-Whitney)|||Differences evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.9556
73934237|NCT01722331|147398620|SUPERIORITY||Difference in percentages|56.6|||<|0.001|TWO_SIDED|95.0|49.6|62.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||62.8|49.6|<0.001
73934238|NCT01722331|147398620|SUPERIORITY||Difference in percentages|58.0|||<|0.001|TWO_SIDED|95.0|51.0|64.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||64.1|51.0|<0.001
73934239|NCT01722331|147398621|SUPERIORITY||Difference in percentages|52.1|||<|0.001|TWO_SIDED|95.0|44.8|58.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||58.5|44.8|<0.001
73934240|NCT01722331|147398621|SUPERIORITY||Difference in percentages|50.9|||<|0.001|TWO_SIDED|95.0|43.6|57.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||57.4|43.6|<0.001
73934241|NCT01722331|147398625|SUPERIORITY||Difference in percentages|32.9|||<|0.001|TWO_SIDED|95.0|26.8|38.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||38.8|26.8|<0.001
74008300|NCT03627767|147566493|SUPERIORITY||Difference in percentage|14.5|||||TWO_SIDED|95.0|6.3|22.8||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.8|6.3|
73934242|NCT01722331|147398625|SUPERIORITY||Difference in percentages|32.1|||<|0.001|TWO_SIDED|95.0|25.9|38.0|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||38.0|25.9|<0.001
73934243|NCT01722331|147398626|SUPERIORITY||Difference in percentages|12.7|||<|0.001|TWO_SIDED|95.0|8.3|17.2|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||17.2|8.3|<0.001
73934244|NCT01722331|147398626|SUPERIORITY||Difference in percentages|12.7|||<|0.001|TWO_SIDED|95.0|8.0|17.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||17.3|8.0|<0.001
73934245|NCT01722331|147398628|OTHER||Difference in least squares means|-7.7|||<|0.001|TWO_SIDED|95.0|-8.6|-6.8|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-6.8|-8.6|<0.001
73934246|NCT01722331|147398628|OTHER||Difference in least squares means|-7.4|||<|0.001|TWO_SIDED|95.0|-8.3|-6.5|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-6.5|-8.3|<0.001
73934247|NCT01722331|147398629|OTHER||Difference in percentages|38.9|||<|0.001|TWO_SIDED|95.0|31.9|45.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||45.4|31.9|<0.001
73934248|NCT01722331|147398629|OTHER||Difference in percentages|36.1|||<|0.001|TWO_SIDED|95.0|29.3|42.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||42.5|29.3|<0.001
73934249|NCT04564833|147398630|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73934250|NCT04564833|147398630|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73934251|NCT04564833|147398631|SUPERIORITY|||||||0.3954|||||||ANCOVA|||||||0.3954
73934252|NCT04564833|147398631|SUPERIORITY|||||||0.0682|||||||ANCOVA|||||||0.0682
73934253|NCT04564833|147398632|SUPERIORITY|||||||0.6755|||||||Fisher Exact|||||||0.6755
73934254|NCT04564833|147398632|SUPERIORITY|||||||0.6758|||||||Fisher Exact|||||||0.6758
73934255|NCT04564833|147398633|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
73934256|NCT04564833|147398633|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
73865770|NCT03836677|147277525|OTHER||Geometric mean ratio to baseline|0.5|||<|0.0001|TWO_SIDED|95.0|0.4|0.63|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.63|0.40|<0.0001
73865771|NCT03836677|147277525|OTHER||Geometric mean ratio to baseline|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.68|0.40|<0.0001
73865772|NCT03836677|147277526|OTHER||Mean Change from Baseline|0.346||||0.0003|TWO_SIDED|95.0|0.182|0.509|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.509|0.182|0.0003
73865773|NCT03836677|147277526|OTHER||Mean Change from Baseline|0.273||||0.0004|TWO_SIDED|95.0|0.14|0.405|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.405|0.140|0.0004
73934257|NCT02753751|147398660|SUPERIORITY|The Mantel-Haenszel test was used, accounting for each hospital as an individual stratum, and to obtain the pooled relative risks across hospitals without adjusting for other baseline factors. (Alert arm is the numerator, control arm is the denominator.) Patients discharged prior to 14 days without an outcome of interest were assumed to be free of that outcome at 14 days. A p-value of \<=0.04 was considered statistically significant to account for the interim analysis.|Risk Ratio (RR)|1.02||||0.67|TWO_SIDED|95.0|0.93|1.13||A p-value of \<=0.04 was considered statistically significant to account for the interim analysis.|Cochran-Mantel-Haenszel|||In our retrospective analysis of patients with AKI at 3 potential study hospitals, the composite outcome was 24.5%. A clinically meaningful relative reduction in this risk would be 20%. 5,024 patients (2,512 in each group) would have 90% power to detect a difference in outcome at least this extreme at a two-sided alpha of 0.05 as calculated using the Cochran-Mantel-Haenszel test. We have elected to increase this number by 20% to account for potential contamination.||1.13|0.93|0.67
73865774|NCT03836677|147277527|OTHER||Mean ratio to baseline|-0.28||||0.2515|TWO_SIDED|95.0|-0.77|0.21|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.21|-0.77|0.2515
73865775|NCT03836677|147277527|OTHER||Mean ratio to baseline|-0.5||||0.004|TWO_SIDED|95.0|-0.81|-0.18|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||-0.18|-0.81|0.0040
73865776|NCT00462748|147277555|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C \< 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.||||<0.001
73865777|NCT00462748|147277555|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C \< 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.||||<0.001
73865778|NCT03233438|147277556|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|2.5||0.003|TWO_SIDED|95.0|0.6|2.6|||t-test, 2 sided|||||2.6|0.6|0.003
73865779|NCT03233438|147277557|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|2.56||0.003|TWO_SIDED|95.0|0.6|2.8|||t-test, 2 sided|||||2.8|0.6|0.003
73865780|NCT03429543|147277587|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.33||0.2935|TWO_SIDED|95.0|-0.99|0.3|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 1 (TG1) consisting of Placebo, Linagliptin 5 mg and Empagliflozin pooled Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||0.30|-0.99|0.2935
73865781|NCT03429543|147277587|OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.33||0.0116|TWO_SIDED|95.0|-1.5|-0.19|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 1 (TG1) consisting of Placebo, Linagliptin 5 mg and Empagliflozin pooled Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||-0.19|-1.50|0.0116
73865782|NCT03429543|147277587|OTHER|Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise.|Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.4||0.1943|TWO_SIDED|95.0|-1.31|0.27|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 2 (TG2) consisting of Placebo, Empagliflozin 25mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||0.27|-1.31|0.1943
73934258|NCT00575588|147398673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.05|0.16||||||||0.16|-0.05|
73934259|NCT00575588|147398674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.2|||<|0.0001|TWO_SIDED|95.0|-38.1|-28.5||Between group comparison significant after controlling overall alpha of the study|Fisher Exact|||||-28.5|-38.1|<0.0001
73934260|NCT00575588|147398675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001||95.0|-2.7|-1.7||Between group comparison significant after controlling overall alpha of the study|ANCOVA|||||-1.7|-2.7|<0.0001
73934261|NCT00575588|147398676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.04|TWO_SIDED|95.0|-0.0046|-0.0001||Between group comparison significant after controlling overall alpha of the study|Mixed Models Analysis|||||-0.0001|-0.0046|0.040
73934262|NCT00575588|147398677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.17|0.06|||Repeated Measures|||||0.06|-0.17|
73934263|NCT00575588|147398678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.9|||||TWO_SIDED|95.0|-39.8|-30.0||||||||-30.0|-39.8|
73934264|NCT00575588|147398679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|95.0|-3.32|-2.2|||Repeated Measures|||||-2.20|-3.32|
73934265|NCT00575588|147398680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0035|STANDARD_ERROR_OF_MEAN|0.0007|||TWO_SIDED|95.0|-0.0048|-0.0022|||Mixed Models Analysis|||||-0.0022|-0.0048|
73972343|NCT04726371|147485763|SUPERIORITY|||||||0.89||||||A Wald test was used to test against the null hypothesis that intervention main effect and interaction effects between intervention and time trends were simultaneously zero and assess for differences in the mean trend of infections over follow-up.|Test of joint null hypothesis from model|Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.||A Poisson GLMM was fit with a main effect for intervention group, linear and quadratic time trends, and interaction effects between intervention and the time trend variables. The model was adjust for stratification factors, baseline infection incidence, agency and included random intercept for group home.|"The point estimates for intervention main effect, intervention by linear time effect, and for intervention by time\^2 interaction effect are described in the paper Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial by Bartels S, Levison JH, Trieu HD, et al., published in 2024 in BMC Public Health, doi:10.1186/s12889-024-18835-w."|||0.89
74008301|NCT03627767|147566493|SUPERIORITY||Difference in percentage|24.7|||<|0.0001|TWO_SIDED|95.0|18.1|31.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.2|18.1|< 0.0001
73934266|NCT00614939|147398681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.151||0.007|TWO_SIDED|95.0|-0.71|-0.12|||ANCOVA|\*Adjusted for baseline HbA1c||||-0.12|-0.71|0.007
73934267|NCT00614939|147398682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.34|STANDARD_ERROR_OF_MEAN|12.847||0.339||95.0|-37.91|13.22|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||13.22|-37.91|0.339
73934268|NCT00614939|147398683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.36|STANDARD_ERROR_OF_MEAN|16.938||0.798|TWO_SIDED|95.0|-38.65|29.93|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||29.93|-38.65|0.798
73934269|NCT00614939|147398684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|44.01|STANDARD_ERROR_OF_MEAN|30.815||0.164|TWO_SIDED|95.0|-18.93|106.94|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||106.94|-18.93|0.164
73934270|NCT00614939|147398685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.713|||TWO_SIDED|95.0|-2.1|0.74|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||0.74|-2.10|
73934271|NCT00614939|147398686|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.941|||TWO_SIDED|95.0|-2.14|1.67|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.67|-2.14|
73934272|NCT00614939|147398687|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|95.0|-1.05|5.93|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||5.93|-1.05|
73934273|NCT00614939|147398688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.82|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|-1.27|-0.37|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=26 for saxagliptin and n=34 for placebo~\*Adjusted for baseline HbA1c"||||-0.37|-1.27|
73934274|NCT00614939|147398689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.98|STANDARD_ERROR_OF_MEAN|18.475|||TWO_SIDED|95.0|-54.28|18.33|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=17 for saxagliptin and n=16 for placebo~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||18.33|-54.28|
73934275|NCT00614939|147398690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.73|STANDARD_ERROR_OF_MEAN|25.326|||TWO_SIDED|95.0|-65.77|34.3|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=5 for saxagliptin and n=11 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||34.30|-65.77|
73865783|NCT03429543|147277587|OTHER|Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise.|Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|0.37||0.0015|TWO_SIDED|95.0|-1.9|-0.45|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 3 (TG3) consisting of Placebo, Empagliflozin 10mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||-0.45|-1.90|0.0015
73865784|NCT03429543|147277588|OTHER||Risk Difference (RD)|-10.0||||1|TWO_SIDED|90.0|-58.7|43.7|||Fisher Exact||Risk difference calculated as \[treatment\]-\[placebo\].|Risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 90% confidence interval based on the method of Chan and Zhang. Patients were assigned to the treatment they were randomised to at the initial randomisation.||43.7|-58.7|1.0000
73934276|NCT00614939|147398691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-38.09|STANDARD_ERROR_OF_MEAN|53.822|||TWO_SIDED|95.0|-144.44|68.26|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=2 for saxagliptin and n=5 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||68.26|-144.44|
73934277|NCT00614939|147398692|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|1.027|||TWO_SIDED|95.0|-2.99|1.04|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=17 for saxagliptin and n=16 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.04|-2.99|
73934278|NCT00614939|147398693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|1.405|||TWO_SIDED|95.0|-3.66|1.89|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=5 for saxagliptin and n=11 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.89|-3.66|
73934279|NCT00614939|147398694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.14|STANDARD_ERROR_OF_MEAN|2.985|||TWO_SIDED|95.0|-8.04|3.76|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=2 for saxagliptin and n=5 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||3.76|-8.04|
73934280|NCT01854827|147398703|SUPERIORITY|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was \> 80%.|Percent of patients|79.3|||||ONE_SIDED|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was \< 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.||63.2|
73934281|NCT01854827|147398704|SUPERIORITY|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was \> 80%.|Percent of patients|79.3|||||ONE_SIDED|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was \< 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.||63.2|
73865785|NCT03429543|147277588|OTHER||Risk Difference (RD)|-10.0||||1|TWO_SIDED|90.0|-58.7|43.7|||Fisher Exact||Risk difference calculated as \[treatment\]-\[placebo\].|Risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 90% confidence interval based on the method of Chan and Zhang. Patients were assigned to the treatment they were randomised to at the initial randomisation.||43.7|-58.7|1.0000
73934282|NCT01854827|147398705|OTHER|Percents with serious AEs prior to liver transplant were calculated, along with one-sided 90% Clopper-Pearson confidence interval lower bounds.|Percent of patients|89.7|||||ONE_SIDED|90.0|75.4||||||||||75.4|
73934283|NCT01854827|147398706|OTHER|Percent of patients with level 3-5 toxicity are presented along with one-sided 90% Clopper-Pearson confidence interval lower bound.|Percent of patients|89.7|||||ONE_SIDED|90.0|75.4||||||||||75.4|
73934284|NCT01854827|147398707|OTHER|Percent of patients with other expected AEs are presented along with one-sided 90% Clopper-Pearson confidence limit lower bound.|Percent of patients|27.6|||||ONE_SIDED|90.0|14.5||||||||||14.5|
73934285|NCT01854827|147398708|SUPERIORITY|One-sided testing for superiority of IVIG to historical control.|Odds Ratio (OR)|0.67||||0.5486|ONE_SIDED|90.0||2.38|||Regression, Logistic|||IVIG was compared to the historical placebo control from the START study (n=64): PMID: 24794368 NCT00294684||2.38||0.5486
73934286|NCT01854827|147398709|SUPERIORITY|One-sided testing for superiority of IVIG relative to historical control.|Odds Ratio (OR)|0.33||||0.8455|ONE_SIDED|90.0||1.22|||Regression, Logistic|||IVIG was compared for superiority to the historical control of START study placebo (N=64). PMID: 24794368 NCT00294684||1.22||0.8455
73934287|NCT01854827|147398710|SUPERIORITY|One-sided.|Odds Ratio (OR)|0.29||||0.8431|ONE_SIDED|90.0||1.24||One-sided|Regression, Logistic|||IVIG was compared for superiority to the historical START placebo control (N=64).||1.24||0.8431
73934288|NCT01854827|147398711|SUPERIORITY|One-sided for IVIG superior to historical START placebo control. PMID: 24794368 NCT00294684|Risk Difference (RD)|-11.9|||||ONE_SIDED|90.0||2.1||||||K-M estimates for survival for IVIG vs the historical START placebo control are provided, along with one-sided 90% upper bounds of the confidence intervals.||2.1||
73934289|NCT02571452|147398713|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|1.53||0.021|TWO_SIDED|95.0|-6.65|-0.55||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||-0.55|-6.65|.021
74030437|NCT02078713|147615160|SUPERIORITY||Odds Ratio (OR)|0.83||||0.23|TWO_SIDED|95.0|0.6|1.13||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving a top score on the 5-point Likert scale at 7 months post-enrollment.||1.13|0.60|0.23
74030438|NCT02078713|147615161|SUPERIORITY||Odds Ratio (OR)|0.91||||0.55|TWO_SIDED|95.0|0.66|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.25|0.66|0.55
74030439|NCT02078713|147615162|SUPERIORITY||Odds Ratio (OR)|1.22||||0.13|TWO_SIDED|95.0|0.92|1.6||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating for hormonal IUD. Patients excluded from analysis if they had not heard of hormonal IUD.||1.6|0.92|0.13
74088815|NCT04060719|147730655|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|10.48|||||TWO_SIDED|90.0|9.74|11.28|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 11.8.|Relative bioavailability||11.28|9.74|
73934290|NCT02571452|147398714|SUPERIORITY||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|0.57||0.568|TWO_SIDED|95.0|-1.26|2.3||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||2.30|-1.26|.568
73934291|NCT02571452|147398715|SUPERIORITY||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-5.87|-2.33||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||-2.33|-5.87|<.001
73934292|NCT02571452|147398716|SUPERIORITY||Mean Difference (Net)|-0.66|STANDARD_ERROR_OF_MEAN|0.49||0.173|TWO_SIDED|95.0|-1.61|0.29||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||0.29|-1.61|.173
73972344|NCT04726371|147485764|SUPERIORITY||||||>|0.99||||||A Wald test was used to test against the null hypothesis that intervention main effect and interaction effects between intervention and time trends were simultaneously zero and assess for differences in the mean trend of scores over follow-up.|Wald test|Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.||A GLMM was fit with a main effect for intervention group, linear and quadratic time trends, and interaction effects between intervention and the time trend variables. The model was adjust for stratification factors, baseline fidelity score, agency and included random intercept for group home.|"The point estimates for intervention main effect, intervention by linear time effect, and intervention by time\^2 interaction effect are described in the paper Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial by Bartels S, Levison JH, Trieu HD, et al., published in 2024 in BMC Public Health, doi:10.1186/s12889-024-18835-w."|||>.99
73972345|NCT04726371|147485765|SUPERIORITY||Hazard Ratio (HR)|1.21|||>|0.99|TWO_SIDED|95.0|0.79|1.84||Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.|Regression, Cox|||A Cox frailty model was fit to evaluate differences in the hazard of vaccination uptake between arms separately within the combined population of residents with SMI and ID/DD. This model included a main effect for intervention arm and additionally adjusted for stratification factors, GH agency, and GH-level log-normal frailties.||1.84|0.79|>.99
74030440|NCT02078713|147615162|SUPERIORITY||Odds Ratio (OR)|0.99||||0.92|TWO_SIDED|95.0|0.75|1.3||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on non-hormonal IUD. Patients were excluded from this analysis if they reported not having heard of the non-hormonal IUD in the post-visit survey.||1.3|0.75|0.92
74030441|NCT02078713|147615162|SUPERIORITY||Odds Ratio (OR)|0.85||||0.17|TWO_SIDED|95.0|0.67|1.07||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating of implant||1.07|0.67|0.17
74088816|NCT04060719|147730656|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|30.03|||||TWO_SIDED|90.0|25.76|35.02|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 25.2.|Relative bioavailability||35.02|25.76|
74088817|NCT04060719|147730657|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|10.39|||||TWO_SIDED|90.0|9.66|11.18|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 11.8.|Relative bioavailability||11.18|9.66|
73934293|NCT00534352|147398717|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Cmin as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|95.47||||||90.0|82.77|110.1||No p-values.|Mixed Models Analysis (Cmin)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Cmin. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||110.1|82.77|
73865786|NCT03429543|147277589|OTHER||Adjusted mean difference|-0.68||||0.4828|TWO_SIDED|95.0|-2.86|1.49|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Fixed categorical effects of treatment, visit, and treatment-by-visit interaction and categorical covariate age (baseline) and continuous, fixed covariates of baseline of response variable and baseline of response variable-by-visit interaction. Covariate visit was treated as repeated measure with an unstructured covariance structure used to model within-patient measurements.||1.49|-2.86|0.4828
73865787|NCT03429543|147277589|OTHER||Adjusted mean difference|-0.38||||0.7047|TWO_SIDED|95.0|-2.64|1.88|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Fixed categorical effects of treatment, visit, and treatment-by-visit interaction and categorical covariate age (baseline) and continuous, fixed covariates of baseline of response variable and baseline of response variable-by-visit interaction. Covariate visit was treated as repeated measure with an unstructured covariance structure used to model within-patient measurements.||1.88|-2.64|0.7047
73865788|NCT03429543|147277590|OTHER|||||||0.8626|||||||Log Rank|||Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study. A log-rank test compared linagliptin and empagliflozin pooled versus placebo up to Week 26.||||0.8626
73865789|NCT03429543|147277590|OTHER|||||||0.2827|||||||Log Rank|||Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study. A log-rank test compared linagliptin and empagliflozin pooled versus placebo up to Week 26.||||0.2827
73865790|NCT03429543|147277591|OTHER||Mean Difference (Final Values)|-5.41||||0.6438|TWO_SIDED|95.0|-28.49|17.67|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||17.67|-28.49|0.6438
73934294|NCT00534352|147398717|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Cmax as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|102.6||||||90.0|92.91|113.3||No p-values.|Mixed Models Analysis (Cmax)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Cmax. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||113.3|92.91|
73865791|NCT03429543|147277591|OTHER||Mean Difference (Final Values)|-35.18||||0.0035|TWO_SIDED|95.0|-58.61|-11.74|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||-11.74|-58.61|0.0035
73865792|NCT03429543|147277591|OTHER||Mean Difference (Final Values)|38.62||||0.031|TWO_SIDED|95.0|4.54|72.7|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||72.70|4.54|0.0310
73865793|NCT03429543|147277591|OTHER||Mean Difference (Final Values)|20.05||||0.1994|TWO_SIDED|95.0|-13.01|53.11|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||53.11|-13.01|0.1994
73865794|NCT03429543|147277592|OTHER||Mean Difference (Final Values)|1.46||||0.1394|TWO_SIDED|95.0|-0.48|3.41|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||3.41|-0.48|0.1394
73865795|NCT03429543|147277592|OTHER||Mean Difference (Final Values)|-0.75||||0.4476|TWO_SIDED|95.0|-2.68|1.19|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.19|-2.68|0.4476
73865796|NCT03429543|147277592|OTHER||Mean Difference (Final Values)|0.05||||0.9789|TWO_SIDED|95.0|-3.8|3.9|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||3.90|-3.80|0.9789
73934295|NCT00534352|147398717|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for AUC24 as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|LS means of ratios|98.97||||||90.0|89.23|109.8||No p-values.|Mixed Models Analysis (AUC24)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of AUC24. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||109.8|89.23|
74008302|NCT03627767|147566493|SUPERIORITY||Difference in percentage|38.5|||<|0.0001|TWO_SIDED|95.0|31.6|45.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||45.3|31.6|< 0.0001
73865797|NCT03429543|147277592|OTHER||Mean Difference (Final Values)|-1.35||||0.5092|TWO_SIDED|95.0|-5.68|2.99|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||2.99|-5.68|0.5092
73934296|NCT00534352|147398717|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Css,av as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|99.3||||||90.0|89.39|110.3||No p-values.|Mixed Models Analysis (Css,av)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Css,av. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||110.3|89.39|
73865798|NCT03429543|147277593|OTHER||Mean Difference (Final Values)|0.91||||0.587|TWO_SIDED|95.0|-2.4|4.22|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.22|-2.40|0.5870
73934297|NCT04788147|147398729|OTHER|"The modified 3+3 design with 6 patients at the 'Recommended RefleXion FDG Dose level' aims to ensure that the observed proportion of patients below activity threshold to be less than 33%.~Probability of Observations at Most 1 of 6 below Activity Threshold True below activity rate 40% 30% 20% 10% Probability at most 1 of 6 patients below activity threshold 0.233 0.420 0.655 0.886"||||||||||||||||"Statistical analysis of the primary endpoint is not applicable to Cohort I. A modified 3+3 design was utilized wherein meeting the activity level threshold, not dose-limiting toxicity, is the endpoint. The RRFD is primarily based upon the lower FDG dose level where 5 to 6 out of 6 subjects have an Activity Concentration greater than 5 kBq/ml."|"Statistical analysis of the primary endpoint is not applicable to Cohort I. A modified 3+3 design was utilized wherein meeting the activity level threshold, not dose-limiting toxicity, is the endpoint. The RRFD is primarily based upon the lower FDG dose level where 5 to 6 out of 6 subjects have an Activity Concentration greater than 5 kBq/ml."|||
73934298|NCT05101252|147398741|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.00 logMAR for distance.|Least-square Mean|-0.08|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|98.75|-0.14|-0.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 22 subjects were required to test for superiority for distance.||-0.01|-0.14|
73934299|NCT05101252|147398741|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for intermediate.|Least-square Mean|0.0|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|98.75|-0.06|0.07|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 12 subjects were required to test for superiority for intermediate.||0.07|-0.06|
73934300|NCT05101252|147398741|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for near.|Least-square Mean|0.09|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|98.75|0.02|0.16|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 60 subjects were required to test for superiority for near.||0.16|0.02|
73934301|NCT05101252|147398742|SUPERIORITY|Superiority was declared if the lower bound of the 98.75% confidence interval was above 32.|Least-square Mean|50.8|STANDARD_ERROR_OF_MEAN|2.922|||TWO_SIDED|98.75|43.1|58.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 99% statistical power, that 13 subjects were required to test for superiority for CLUE vision scores.||58.5|43.1|
73934302|NCT05101252|147398743|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the least-square mean difference was below 0.05 logMAR.|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|-0.05|0.05|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Test minus Control|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 95% statistical power, that 60 subjects were required to test for non-inferiority of the Test compared to the Control for distance (4m).||0.05|-0.05|
73934303|NCT01144338|147398744|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.91||||0.061|TWO_SIDED|95.0|0.832|1.004|||Regression, Cox|||||1.004|0.832|0.061
73934304|NCT01144338|147398745|NON_INFERIORITY|Non-inferiority test of EQW over Placebo H0: HR ≥ 1.3 vs. H1: HR \< 1.3|Hazard Ratio (HR)|0.91|||<|0.001|TWO_SIDED|95.0|0.832|1.004|||Regression, Cox|||This analysis uses the same endpoint and cox regression method as the primary efficacy analysis. However, the statistical hypothesis is a non-inferiority test with a margin of HR=1.3.||1.004|0.832|< 0.001
73934305|NCT01144338|147398746|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.86||||0.016|TWO_SIDED|95.0|0.77|0.97|||Regression, Cox|||||0.97|0.77|0.016
73934306|NCT01144338|147398747|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.88||||0.096|TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|||||1.02|0.76|0.096
73934307|NCT01144338|147398748|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.97||||0.622|TWO_SIDED|95.0|0.85|1.1|||Regression, Cox|||||1.10|0.85|0.622
73934308|NCT01144338|147398749|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.85||||0.095|TWO_SIDED|95.0|0.7|1.03|||Regression, Cox|||||1.03|0.70|0.095
73865799|NCT03429543|147277593|OTHER||Mean Difference (Final Values)|-1.42||||0.3967|TWO_SIDED|95.0|-4.72|1.88|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.88|-4.72|0.3967
73865800|NCT03429543|147277593|OTHER||Mean Difference (Final Values)|2.53||||0.5414|TWO_SIDED|95.0|-6.42|11.47|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||11.47|-6.42|0.5414
73865801|NCT03429543|147277593|OTHER||Mean Difference (Final Values)|0.0||||0.9995|TWO_SIDED|95.0|-10.13|10.13|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||10.13|-10.13|0.9995
73865802|NCT03429543|147277594|OTHER||Mean Difference (Final Values)|1.5||||0.2433|TWO_SIDED|95.0|-1.03|4.02|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.02|-1.03|0.2433
73865803|NCT03429543|147277594|OTHER||Mean Difference (Final Values)|0.02||||0.9878|TWO_SIDED|95.0|-2.52|2.56|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||2.56|-2.52|0.9878
73934309|NCT01144338|147398750|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|1.05||||0.402|TWO_SIDED|95.0|0.94|1.18|||Regression, Cox|||||1.18|0.94|0.402
73934310|NCT01144338|147398751|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.94||||0.485|TWO_SIDED|95.0|0.78|1.13|||Regression, Cox|||||1.13|0.78|0.485
73865804|NCT03429543|147277594|OTHER||Mean Difference (Final Values)|3.33||||0.567|TWO_SIDED|95.0|-9.0|15.65|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||15.65|-9.00|0.5670
73865805|NCT03429543|147277594|OTHER||Mean Difference (Final Values)|-6.62||||0.2348|TWO_SIDED|95.0|-18.19|4.95|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.95|-18.19|0.2348
73865806|NCT03429543|147277595|OTHER||Rate difference (percentage)|6.0||||0.3536|TWO_SIDED|95.0|-7.7|19.9|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||19.9|-7.7|0.3536
73865807|NCT03429543|147277595|OTHER||Rate difference (percentage)|11.7||||0.0914|TWO_SIDED|95.0|-2.4|26.3|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||26.3|-2.4|0.0914
73865808|NCT03429543|147277595|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
73865809|NCT03429543|147277595|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
73934311|NCT04796610|147398752|SUPERIORITY||Odds Ratio (OR)|0.55||||0.49|TWO_SIDED|95.0|0.1|2.98|||Regression, Logistic|Model is adjusted for participant age|Results are presented for an indicator where 0=control and 1=intervention|||2.98|.1|0.49
73934312|NCT04796610|147398753|SUPERIORITY||Odds Ratio (OR)|16.82||||0.011|TWO_SIDED|95.0|1.93|146.91||Model is adjusted for participant age|Regression, Logistic||Results are presented for an indicator where 0=control and 1=intervention|||146.91|1.93|.011
74008303|NCT03627767|147566493|SUPERIORITY||Difference in percentage|13.9|||||TWO_SIDED|95.0|5.6|22.3||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.3|5.6|
73934313|NCT04796610|147398754|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.03|TWO_SIDED|95.0|0.07|0.97|||Regression, Linear|Model is adjusted for participant age|Results are presented for an indicator where 0=control and 1=intervention|||0.97|0.07|.03
73934314|NCT02401672|147398755|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73934315|NCT02401672|147398756|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73934316|NCT02401672|147398757|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73972346|NCT04726371|147485766|SUPERIORITY||Hazard Ratio (HR)|0.99|||>|0.99|TWO_SIDED|95.0|0.86|1.15||Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.|Regression, Cox|||A Cox frailty model was fit to evaluate differences in the hazard of vaccination uptake between arms separately within the staff population. This model included a main effect for intervention arm and additionally adjusted for stratification factors, GH agency, and GH-level log-normal frailties.||1.15|0.86|>.99
73972347|NCT03625115|147485807|EQUIVALENCE|A two-tailed t-test was done to compare the mean Bayley cognitive scores between the groups.||||||0.3|||||||t-test, 2 sided|||||||0.30
73972348|NCT03625115|147485808|SUPERIORITY||Pearson chi square (1)|8.51||||0.004|TWO_SIDED||||||Chi-squared|||Chi-square test of independence to determine if there was a significant difference between intervention arms for those who completed a multidisciplinary evaluation (referral completed).||||.004
73972349|NCT03625115|147485809|SUPERIORITY||Pearson chi square (1)|0.05||||0.82|TWO_SIDED||||||Chi-squared|||Chi-square test of independence to determine if there was a significant difference between intervention arms for those who began early intervention services.||||.82
73972350|NCT03625115|147485810|EQUIVALENCE|A two-tailed t-test was done to compare the mean Bayley language scores between the groups.||||||0.69|||||||t-test, 2 sided|||||||0.69
73972351|NCT03625115|147485812|EQUIVALENCE|two tailed t-test to compare the means of factor 1 between groups||||||0.858|||||||t-test, 2 sided|||Analysis of factor 1 items from the parent engagement questionnaire. Factor 1 (Buy-in) I am open to getting EI for my child. EI can help my child. EI can teach me new ways to help my child.||||.858
74088818|NCT04578886|147730658|SUPERIORITY||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|3.7||0.22|TWO_SIDED|95.0|2.3|4.4|||t-test, 2 sided|||||4.4|2.3|0.22
73934317|NCT02401672|147398758|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
73934318|NCT02059148|147398768|SUPERIORITY_OR_OTHER||Ratio of Geometric LSMeans|1.24|||||TWO_SIDED|90.0|1.11|1.38||||||||1.38|1.11|
73934319|NCT02059148|147398769|SUPERIORITY_OR_OTHER||Ratio of Geometric LSMeans|1.14|||||TWO_SIDED|90.0|1.05|1.23||||||||1.23|1.05|
73934320|NCT02059148|147398770|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.95||||0.0006|TWO_SIDED|90.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|1.00|0.0006
73972352|NCT03625115|147485812|EQUIVALENCE|two tailed t-test to compare the means of factor 2 between groups||||||0.995|||||||t-test, 2 sided|||"Analysis of factor 2 items from the parent engagement questionnaire.~Factor 2 (early intervention consequences):~EI could have negative consequences for my child. Getting EI for my child reflects negatively on me as a parent."||||.995
73972353|NCT03625115|147485812|EQUIVALENCE|two tailed t-test to compare the means of factor 3 between groups||||||0.049|||||||t-test, 2 sided|||"Analysis of factor 3 items from the parent engagement questionnaire.~Factor 3 (Knowledge/Self-Efficacy):~I know how to get EI for my child. I understand how the EI process works. If I have questions about EI, I know who to call. 12. I know my child's rights to EI under the law."||||.049
73972354|NCT03625115|147485813|SUPERIORITY||Odds Ratio (OR)|1.87||||0.02|TWO_SIDED|95.0|1.09|3.21|||Regression, Logistic|||A logistic regression was run to determine if the intervention arm, adjusted for child sex, income, maternal education, and primary care site, was associated with the completion of early intervention referrals for families with an adverse childhood experience survey score of greater than 2.||3.21|1.09|.02
73972355|NCT04028284|147485839|OTHER|Two-sided inferential test||||||0.02||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction. The a priori threshold for statistical significance was P \< 0.05 for the primary outcome.|t-test, 2 sided|||||||0.02
73972356|NCT04028284|147485840|OTHER|Inferential two-sided test||||||0.31|||||||t-test, 2 sided|||||||0.31
73972357|NCT04028284|147485841|OTHER|Inferential two-sided test||||||0.01||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction.|t-test, 2 sided|||||||0.01
73972358|NCT04028284|147485842|OTHER|Inferential two-sided test||||||0.03||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction.|t-test, 2 sided|||||||0.03
73972359|NCT04028284|147485843|OTHER|Inferential two-sided test||||||0.56|||||||t-test, 2 sided|||||||0.56
73972360|NCT04028284|147485844|OTHER|Inferential two-sided test||||||0.78|||||||t-test, 2 sided|||||||0.78
73934321|NCT02673697|147398796|NON_INFERIORITY|"The primary analysis will calculate the Bayesian posterior probability that the difference \[MACCECONTROL~\- MACCEPERCEVAL\] is lower than 0.05 (predetermined non-inferiority margin): The null hypothesis will be rejected, and non-inferiority concluded, if the posterior probability exceeds 0.9775 at the final analysis."||||||0.9914||||||The null hypothesis will be rejected, and non-inferiority concluded, if the posterior probability exceeds 0.9775 at the final analysis.|Bayesian|||"A the primary analysis will compare Perceval valve (Treatment arm) vs. standard sutured stented valve (Control arm) on the Per Protocol population.~A one-sided non-inferiority test, using the non-inferiority margin Δ=0.05, will be performed to compare the two arms on the proportion of subjects that are event-free at one year (primary analysis)."||||0.9914
73972361|NCT04028284|147485845|OTHER|Inferential two-sided test||||||0.24|||||||Fisher Exact|||||||0.24
74091656|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 3. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.30|0.90|<0.001
73934322|NCT03893448|147398819|OTHER||Percentage Point Difference|-4.8|||=|0.039|TWO_SIDED|95.0|-9.3|-0.2|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site erythema Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.2|-9.3|= 0.039
73934323|NCT03893448|147398819|OTHER||Percentage Point Difference|-0.4|||=|0.836|TWO_SIDED|95.0|-4.6|3.7|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site induration Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||3.7|-4.6|= 0.836
73865810|NCT03429543|147277596|OTHER||Rate difference (percentage)|2.4||||0.7789|TWO_SIDED|95.0|-15.2|19.5|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||19.5|-15.2|0.7789
73865811|NCT03429543|147277596|OTHER||Rate difference (percentage)|10.1||||0.2548|TWO_SIDED|95.0|-7.7|28.1|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||28.1|-7.7|0.2548
73865812|NCT03429543|147277596|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
73865813|NCT03429543|147277596|OTHER||Rate difference (percentage)|26.7||||0.5671|TWO_SIDED|90.0|-30.8|70.8|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||70.8|-30.8|0.5671
73865814|NCT01818492|147277597|SUPERIORITY|||||||0.0134|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%.||||0.0134
73865815|NCT01818492|147277598|SUPERIORITY|||||||0.0031|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%||||0.0031
73865816|NCT01818492|147277599|SUPERIORITY|||||||0.0205|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%||||0.0205
73865817|NCT01818492|147277600|SUPERIORITY|||||||0.0053|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%.||||0.0053
73865818|NCT03249103|147277621|OTHER|||||||0.032|||||||t-test, 2 sided|||placebo - NYX-2925 20 mg||||0.032
73865819|NCT03249103|147277622|OTHER|||||||0.039|||||||t-test, 2 sided|||placebo - NYX-2925 200 mg||||0.039
73865820|NCT03249103|147277623|OTHER|||||||0.0072|||||||t-test, 2 sided|comparing Week 2 (Placebo) to Week 6 (NYX-2925 200 mg)||||||0.0072
73865821|NCT02428413|147277624|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
73865822|NCT02428413|147277625|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||||||0.26
73934324|NCT03893448|147398819|OTHER||Percentage Point Difference|2.9|||=|0.235|TWO_SIDED|95.0|-1.9|7.6|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site pain Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||7.6|-1.9|= 0.235
73934325|NCT03893448|147398819|OTHER||Percentage Point Difference|2.4|||=|0.26|TWO_SIDED|95.0|-1.7|6.5|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site swelling Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||6.5|-1.7|= 0.260
73934326|NCT03893448|147398820|OTHER||Percentage Point Difference|-1.8|||=|0.446|TWO_SIDED|95.0|-6.3|2.8|||Miettinen & Nurminen||V114-Prevnar 13™|Decreased appetite Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.8|-6.3|= 0.446
73934327|NCT03893448|147398820|OTHER||Percentage Point Difference|1.0|||=|0.622|TWO_SIDED|95.0|-3.0|5.1|||Miettinen & Nurminen||V114-Prevnar 13™|Irritability Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||5.1|-3.0|= 0.622
73934328|NCT03893448|147398820|OTHER||Percentage Point Difference|-3.0|||=|0.202|TWO_SIDED|95.0|-7.6|1.6|||Miettinen & Nurminen||V114-Prevnar 13™|Somnolence (drowsiness) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||1.6|-7.6|= 0.202
73865823|NCT02025439|147277628|OTHER||Mean Difference (Final Values)|0.071|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73865824|NCT03688100|147277633|SUPERIORITY||ratio of means|0.62||||0.005|TWO_SIDED|95.0|0.45|0.86||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Emergency Department visits AT 3 MONTHS||0.86|0.45|0.005
73865825|NCT03688100|147277633|SUPERIORITY||ratio of means|0.7||||0.008|TWO_SIDED|95.0|0.6|0.86||The a priori threshold for statistical significance is p\<0.05|Zero Inflated Poisson (ZIP) Model||For the ratio of means for ED visits, BA is the numerator and MEDS is the denominator.|Emergency Department visits AT 6 MONTHS||0.86|0.60|0.008
73865826|NCT03688100|147277633|SUPERIORITY||ratio of means|0.73||||0.0001|TWO_SIDED|95.0|0.62|0.85||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means for ED visits , BA is numerator and MEDS is the denominator.|Emergency Department visits AT 12 MONTHS||0.85|0.62|0.0001
73865827|NCT03688100|147277634|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model|||Differences in the number of hospital readmissions between BA and MEDS at 3, 6, and 12 months||||>0.05
73865828|NCT03688100|147277635|SUPERIORITY||ratio of means|0.83||||0.002|TWO_SIDED|95.0|0.75|0.92||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Days in the Hospital at 3 months||0.92|0.75|0.002
73865829|NCT03688100|147277635|SUPERIORITY||ratio of means|0.81||||0.005|TWO_SIDED|95.0|0.75|0.87||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is numerator and MEDS is the denominator.|Days in the Hospital at 6 MONTHS||0.87|0.75|0.005
73865830|NCT03688100|147277635|SUPERIORITY||ratio of means|0.64|||<|0.0001|TWO_SIDED|95.0|0.6|0.68||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Days in the Hospital AT 12 MONTHS||0.68|0.60|<0.0001
73865831|NCT03688100|147277636|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is p\<0.05.|Kaplan Meier survival plots|||||||>0.05
73865832|NCT01786252|147277637|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the vehicle group.||||<0.05
73934329|NCT03893448|147398820|OTHER||Percentage Point Difference|0.0|||=|0.985|TWO_SIDED|95.0|-2.4|2.3|||Miettinen & Nurminen||V114-Prevnar 13™|Urticaria (Hives) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.3|-2.4|= 0.985
73934330|NCT03893448|147398821|OTHER||Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4|||||V114-Prevnar 13™|Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.4|-0.4|
73934331|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-5.2|-1.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 1 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-1.8|-5.2|< 0.001
73934332|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|15.6|||<|0.001|TWO_SIDED|95.0|12.1|19.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 3 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||19.2|12.1|< 0.001
73934333|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.0|-0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 4 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.6|-4.0|< 0.001
73934334|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-2.1|||<|0.001|TWO_SIDED|95.0|-4.2|-0.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 5 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.2|-4.2|< 0.001
73934335|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-4.9|||<|0.001|TWO_SIDED|95.0|-7.1|-3.0||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 6A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-3.0|-7.1|< 0.001
73934336|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-6.6|-0.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 6B Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.3|-6.6|< 0.001
73972362|NCT05565820|147485873|SUPERIORITY||difference in proportions|-0.335|STANDARD_ERROR_OF_MEAN|0.149||0.025|TWO_SIDED|||||Alpha: .05|Z-test for difference in proportions|Z: 2.246 Cohen's d: .590|Direction of comparison: Vamousse Day 2 proportion of live lice - Nix Day 2 proportion of live lice|"Null hypothesis: At Day 2 the proportion of lice free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.025
73865833|NCT01786252|147277637|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the hCG group.||||>0.05
73934337|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.9|-0.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 7F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.1|-1.9|< 0.001
73934338|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-2.8|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 9V Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.6|-2.8|< 0.001
73972363|NCT05565820|147485873|SUPERIORITY||Difference in proportions|0.348|STANDARD_ERROR_OF_MEAN|0.141||0.014|TWO_SIDED|||||Alpha: .05.|Z-test for difference in proportions|Z 2.469 Cohen's d .660|Direction of comparison: Vamousse Day 7 proportion live lice free - Nix Day 7 proportion live lice free|"Null hypothesis: At Day 7 the proportion of lice free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.014
73972364|NCT05565820|147485873|SUPERIORITY||Difference in proportions|0.283|STANDARD_ERROR_OF_MEAN|0.147||0.054|TWO_SIDED|||||Alpha: .05|Z-test for difference in proportions|Z: 1.920 Cohen's d: .513|Vamousse Day 14 proportion live lice free - Nix Day 14 proportion live lice free|"Null hypothesis: At Day 14 the proportion of lice-free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.054
73865834|NCT01786252|147277637|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare stromal staging between hCG and IVF media group.||||<0.01
73934339|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.6|1.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 14 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||1.6|-1.6|< 0.001
73934340|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.6|0.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 18C Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.7|-2.6|< 0.001
73934341|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.8|||<|0.001|TWO_SIDED|95.0|-3.2|-0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 19A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.8|-3.2|< 0.001
73934342|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-2.1|-0.4||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 19F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.4|-2.1|< 0.001
73934343|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-3.2|2.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 23F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.7|-3.2|< 0.001
73934344|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|6.7|||<|0.001|TWO_SIDED|95.0|4.6|9.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 22F This analysis represents the difference between response rate to Serotype 22F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||9.2|4.6|< 0.001
73934345|NCT03893448|147398822|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-4.5|||<|0.001|TWO_SIDED|95.0|-7.8|-1.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 33F This analysis represents the difference between response rate to Serotype 33F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-1.3|-7.8|< 0.001
73934346|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.64|||<|0.001|TWO_SIDED|95.0|0.59|0.69|||t-test, 1 sided||V114/Prevnar 13™|Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.69|0.59|< 0.001
73934347|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.73|||<|0.001|TWO_SIDED|95.0|1.61|1.87|||t-test, 1 sided||V114/Prevnar 13™|Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.87|1.61|< 0.001
73934348|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.95|||<|0.001|TWO_SIDED|95.0|0.88|1.03|||t-test, 1 sided||V114/Prevnar 13™|Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.03|0.88|< 0.001
73934349|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.72|||<|0.001|TWO_SIDED|95.0|0.66|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.66|< 0.001
73934350|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.52|||=|0.167|TWO_SIDED|95.0|0.48|0.58|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.58|0.48|= 0.167
74088819|NCT04578886|147730658|SUPERIORITY||Risk Ratio (RR)|1.3307||||0.015|TWO_SIDED|95.0|1.0571|1.6751||unadjusted for covariates|Regression, Linear|||"Null Hypothesis: The administration of guanfacine in critically ill patients in the intensive unit has no effect on the duration of delirium.~Continuous variables will be summarized using sample mean and sample variance whereas categorical variables will be summarized as proportions. Logistic regression models will examine whether age, gender, or comorbities associated with incidence of delirium when Guanfacine is administered."||1.6751|1.0571|0.0150
73934351|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.81|||<|0.001|TWO_SIDED|95.0|0.71|0.93|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.93|0.71|< 0.001
74088820|NCT03998436|147730667|SUPERIORITY||Odds Ratio (OR)|2.126||||0.0276|TWO_SIDED|95.0|1.08|4.17|||Chi-squared|||||4.17|1.08|0.0276
74088821|NCT03998436|147730668|SUPERIORITY||Odds Ratio (OR)|2.708||||0.0126|TWO_SIDED|95.0|1.22|5.99|||Chi-squared|||||5.99|1.22|0.0126
73934352|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.71|< 0.001
73934353|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.91|||<|0.001|TWO_SIDED|95.0|0.84|1.0|||t-test, 1 sided||V114/Prevnar 13™|Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.00|0.84|< 0.001
73934354|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.78|||t-test, 1 sided||V114/Prevnar 13™|Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.78|0.63|< 0.001
73934355|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.76|||<|0.001|TWO_SIDED|95.0|0.7|0.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.70|< 0.001
73934356|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.71|||<|0.001|TWO_SIDED|95.0|0.65|0.77|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.77|0.65|< 0.001
73865835|NCT01786252|147277637|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular dating between hCG and IVF media groups.||||>0.05
73934357|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.69|0.79|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.79|0.69|< 0.001
73934358|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||t-test, 1 sided||V114/Prevnar 13™|Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.99|0.80|< 0.001
74088822|NCT00484419|147730825|SUPERIORITY_OR_OTHER|||||||0.0061||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0061
74088823|NCT00484419|147730825|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.1090
73865836|NCT01786252|147277638|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73865837|NCT01786252|147277639|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73865838|NCT01786252|147277640|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73934359|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|3.64|||<|0.001|TWO_SIDED|95.0|3.33|3.98|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||3.98|3.33|< 0.001
73934360|NCT03893448|147398823|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.24|||<|0.001|TWO_SIDED|95.0|1.1|1.39|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.39|1.10|< 0.001
73934361|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.66|||<|0.001|TWO_SIDED|95.0|0.62|0.72|||t-test, 1 sided||V114/Prevnar 13™|Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.72|0.62|< 0.001
73934362|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.35|||<|0.001|TWO_SIDED|95.0|1.25|1.46|||t-test, 1 sided||V114/Prevnar 13™|Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.46|1.25|< 0.001
73934363|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.84|||t-test, 1 sided||V114/Prevnar 13™|Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.84|0.71|< 0.001
73934364|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.63|||<|0.001|TWO_SIDED|95.0|0.58|0.69|||t-test, 1 sided||V114/Prevnar 13™|Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.69|0.58|< 0.001
73934365|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.6|||<|0.001|TWO_SIDED|95.0|0.54|0.65|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.65|0.54|< 0.001
73934366|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.81|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.81|0.67|< 0.001
73972365|NCT05565820|147485874|SUPERIORITY|"To check on the effect of the non-normality of the change proportions, the nonparametric Mann-Whitney test was also performed.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Mean Difference (Final Values)|0.295|STANDARD_ERROR_OF_MEAN|0.1148||0.02|TWO_SIDED|95.0|0.052|0.537||Alpha = .05 t: 2.567 df (adjusted, see comment below): 16.83 Mann-Whitney Z: 2.830 p(2-tailed) of Mann-Whitney Z: .005 Cohen's d = 1.023|t-test, 2 sided|Degrees of freedom for the t-test were adjusted for inequality of variances between the groups using the Satterthwaite correction: df(adj) = 16.83|Direction of comparison: Vamousse prop. reduction in live lice count from Day O - Nix prop. reduction in live lice count from Day O|"Null hypothesis: At Day 2 the mean proportion of decrease from Day 0 in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 2 change proportions deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on the mean change proportions."||.537|.052|.020
74008304|NCT03627767|147566501|SUPERIORITY||Difference in percentage|3.0|||=|0.4815|TWO_SIDED|95.0|-5.3|11.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||11.3|-5.3|= 0.4815
73865839|NCT02437084|147277688|OTHER|||||||0.01|||||||Paired samples t test, 2 sided|SSPG concentration was log-transformed for statistical analysis; degrees of freedom = 69||Null hypothesis: There will be no change in steady-state plasma glucose (SSPG) concentration after treatment with atorvastatin 40 mg daily for 9 - 10 weeks.||||0.01
73865840|NCT02437084|147277689|OTHER||||||<|0.001|||||||Paired samples t test, 2 sided|Insulin secretion rate AUC was log-transformed for statistical analysis; degrees of freedom = 63.||Null hypothesis: There will be no change in insulin secretion rate AUC after treatment with atorvastatin 40 mg daily for 9 - 10 weeks.||||<0.001
74008305|NCT03627767|147566501|SUPERIORITY||Difference in percentage|-1.8|||=|0.6748|TWO_SIDED|95.0|-10.3|6.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||6.6|-10.3|= 0.6748
73865841|NCT02437084|147277690|OTHER|||||||0.1|||||||Paired samples t test, 2 sided|Degrees of freedom = 70||Null hypothesis: There will be no change in fasting plasma glucose concentration after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.10
73865842|NCT02437084|147277691|OTHER|||||||0.01|||||||Paired samples t test, 2 sided|Fasting plasma insulin concentration was log-transformed for statistical analysis; degrees of freedom = 68||Null hypothesis: There will be no change in fasting plasma insulin concentration after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.01
73865843|NCT02437084|147277692|OTHER|||||||0.03|||||||Paired samples t test, 2 sided|Degrees of freedom = 70||Null hypothesis: There will be no change in OGTT glucose AUC after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.03
73865844|NCT02437084|147277693|OTHER|||||||0.27|||||||Paired samples t test, 2 sided|OGTT insulin AUC was log-transformed for statistical analysis; degrees of freedom = 63||Null hypothesis: There will be no change in OGTT insulin AUC after treatment with atorvastatin 40 mg daily for 8 weeks.||||0.27
73865845|NCT00651625|147277720|SUPERIORITY_OR_OTHER||non-applicable|||||0.05|TWO_SIDED||||||t-test, 2 sided|||group comparisons using t-test and confidence intervals.||||0.05
73865846|NCT04018313|147277724|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|105.62|||||TWO_SIDED|90.0|95.91|116.31||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||116.31|95.91|
73865847|NCT04018313|147277724|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax|Ratio of geometric least square means|98.72|||||TWO_SIDED|90.0|89.76|108.58||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||108.58|89.76|
73865848|NCT04018313|147277724|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|93.47|||||TWO_SIDED|90.0|85.09|102.68||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||102.68|85.09|
73865849|NCT04018313|147277725|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|104.0|||||TWO_SIDED|90.0|94.96|113.89||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||113.89|94.96|
73865850|NCT04018313|147277725|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|99.3|||||TWO_SIDED|90.0|90.79|108.61||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||108.61|90.79|
73865851|NCT04018313|147277725|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|95.48|||||TWO_SIDED|90.0|87.36|104.37||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||104.37|87.36|
73865852|NCT04018313|147277726|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|113.14|||||TWO_SIDED|90.0|103.15|124.11||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||124.11|103.15|
74039402|NCT04847141|147632409|SUPERIORITY||Difference in Percentage|4.9||||0.2059|TWO_SIDED|95.0|-2.9|13.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 29||13.2|-2.9|0.2059
74008306|NCT03627767|147566501|SUPERIORITY||Difference in percentage|-5.1|||||TWO_SIDED|95.0|-13.4|3.2||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.2|-13.4|
74008307|NCT03627767|147566501|SUPERIORITY||Difference in percentage|24.0|||<|0.0001|TWO_SIDED|95.0|17.8|30.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.3|17.8|< 0.0001
74008308|NCT03627767|147566501|SUPERIORITY||Difference in percentage|42.3|||<|0.0001|TWO_SIDED|95.0|35.6|49.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||49.0|35.6|< 0.0001
74008309|NCT03627767|147566501|SUPERIORITY||Difference in percentage|18.4|||||TWO_SIDED|95.0|10.2|26.6||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions||26.6|10.2|
74008310|NCT03627767|147566501|SUPERIORITY||Difference in percentage|24.6|||<|0.0001|TWO_SIDED|95.0|18.2|31.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.0|18.2|< 0.0001
74008311|NCT03627767|147566501|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|33.7|47.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||47.3|33.7|< 0.0001
74008312|NCT03627767|147566501|SUPERIORITY||Difference in percentage|15.9|||||TWO_SIDED|95.0|7.6|24.1||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.1|7.6|
74008313|NCT03627767|147566501|SUPERIORITY||Difference in percentage|18.8|||<|0.0001|TWO_SIDED|95.0|12.6|25.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.1|12.6|< 0.0001
74008314|NCT03627767|147566501|SUPERIORITY||Difference in percentage|34.5|||<|0.0001|TWO_SIDED|95.0|27.6|41.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||41.5|27.6|< 0.0001
74008315|NCT03627767|147566501|SUPERIORITY||Difference in percentage|15.6|||||TWO_SIDED|95.0|7.5|23.7||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||23.7|7.5|
74008316|NCT03627767|147566501|SUPERIORITY||Difference in percentage|18.7|||<|0.0001|TWO_SIDED|95.0|12.4|25.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.0|12.4|< 0.0001
74008317|NCT03627767|147566501|SUPERIORITY||Difference in percentage|32.3|||<|0.0001|TWO_SIDED|95.0|25.4|39.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||39.2|25.4|< 0.0001
74008318|NCT03627767|147566501|SUPERIORITY||Difference in percentage|13.7|||||TWO_SIDED|95.0|5.6|21.7||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||21.7|5.6|
74008319|NCT03627767|147566502|SUPERIORITY||LSM difference|0.1|||=|0.7373|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.5|= 0.7373
74008320|NCT03627767|147566502|SUPERIORITY||LSM difference|-0.1|||=|0.8092|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.5|-0.7|= 0.8092
74008321|NCT03627767|147566502|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.8|0.4||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-0.8|
73865853|NCT04018313|147277726|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|103.88|||||TWO_SIDED|90.0|94.83|113.8||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||113.80|94.83|
73865854|NCT04018313|147277726|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|91.82|||||TWO_SIDED|90.0|83.87|100.52||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||100.52|83.87|
73865855|NCT04566692|147277791|NON_INFERIORITY|The bi-weekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \> 0.8.|GLSM Ratio|1.035|||||TWO_SIDED|90.0|1.003|1.0685||||||Geometric least-squares means (GLSMs), GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participant as a random effect.||1.0685|1.0030|
73865856|NCT04566692|147277794|NON_INFERIORITY|The biweekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \> 0.8.|GLSM Ratio|0.97|||||TWO_SIDED|90.0|0.9447|0.9957||||||GLSMs, GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participants as a random effect.||0.9957|0.9447|
73865857|NCT01300260|147277826|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.96|||<|0.001|TWO_SIDED|95.0|2.41|3.64||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.64|2.41|<0.001
73865858|NCT01300260|147277826|SUPERIORITY_OR_OTHER||Geometric least squares (LS) means ratio|5.4|||<|0.001|TWO_SIDED|95.0|4.09|7.13||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||7.13|4.09|<0.001
73865859|NCT01300260|147277827|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|3.09|||<|0.001|TWO_SIDED|95.0|2.66|3.59||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.59|2.66|<0.001
73865860|NCT01300260|147277827|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|7.92|||<|0.001|TWO_SIDED|95.0|4.82|13.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||13.0|4.82|<0.001
73865861|NCT01300260|147277828|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|4.15|||<|0.001|TWO_SIDED|95.0|3.45|5.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||5.00|3.45|<0.001
73865862|NCT01300260|147277828|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|3.78|||<|0.001|TWO_SIDED|95.0|2.99|4.78||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||4.78|2.99|<0.001
73865863|NCT01300260|147277829|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.04||||0.011|TWO_SIDED|95.0|1.26|3.31||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.31|1.26|0.011
73865864|NCT01300260|147277829|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.44|||<|0.001|TWO_SIDED|95.0|1.71|3.47||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.47|1.71|<0.001
73865865|NCT01300260|147277830|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.22||||0.021|TWO_SIDED|95.0|1.04|1.43||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.43|1.04|0.021
73865866|NCT01300260|147277830|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.39|||<|0.001|TWO_SIDED|95.0|1.27|1.53||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.53|1.27|<0.001
73865867|NCT01300260|147277831|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.43||||0.009|TWO_SIDED|95.0|1.14|1.8||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.80|1.14|0.009
73865868|NCT01300260|147277831|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.75|||<|0.001|TWO_SIDED|95.0|1.59|1.94||P-value is 2-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.94|1.59|<0.001
73865869|NCT00439374|147277838|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.79|1.35||||||All deliveries less than 37 weeks||1.35|0.79|
73865870|NCT00439374|147277838|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.7|1.4||||||Spontaneous deliveries||1.40|0.70|
73865871|NCT00439374|147277838|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.65|1.84||||||Medically-indicated deliveries||1.84|0.65|
73865872|NCT00439374|147277839|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||||||0.93
73865873|NCT00439374|147277840|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.61|1.8||||||||1.80|0.61|
73865874|NCT00439374|147277841|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.58|1.21||||||||1.21|0.58|
73865875|NCT00439374|147277842|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.54|1.43||||||||1.43|0.54|
74030442|NCT02078713|147615162|SUPERIORITY||Odds Ratio (OR)|0.71||||0.009|TWO_SIDED|95.0|0.54|0.92||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on condoms. Patients were excluded from this analysis if they reported not having heard of condoms in the post-visit survey.||0.92|0.54|0.009
73934367|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.7|||<|0.001|TWO_SIDED|95.0|0.65|0.77|||t-test, 1 sided||V114/Prevnar 13™|Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.77|0.65|< 0.001
73934368|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.67|< 0.001
73934369|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.81|||<|0.001|TWO_SIDED|95.0|0.73|0.89|||t-test, 1 sided||V114/Prevnar 13™|Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.89|0.73|< 0.001
73934370|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.85|||<|0.001|TWO_SIDED|95.0|0.78|0.93|||t-test, 1 sided||V114/Prevnar 13™|Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.93|0.78|< 0.001
73934371|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.68|< 0.001
73934372|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.79|||<|0.001|TWO_SIDED|95.0|0.74|0.86|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.86|0.74|< 0.001
73934373|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.61|||<|0.001|TWO_SIDED|95.0|0.56|0.68|||t-test, 1 sided||V114/Prevnar 13™|Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.68|0.56|< 0.001
73934374|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|4.69|||<|0.001|TWO_SIDED|95.0|4.3|5.11|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||5.11|4.30|< 0.001
73957830|NCT03068468|147451199|SUPERIORITY||Difference|0.1||||0.9815|TWO_SIDED|95.0|-8.1|8.3|||MMRM|||Color Trails Test 1: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Color trails Test 1 as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for Color Trails Test 1, baseline Color Trails Test 1 by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||8.3|-8.1|0.9815
73957831|NCT03068468|147451199|SUPERIORITY||Difference|0.0||||0.9869|TWO_SIDED|95.0|-5.7|5.6|||MMRM|||Color Trails Test 2: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Color Trails Test 2 as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for Color Trails Test 2, baseline Color Trails Test 2 by time interaction, and region.||5.6|-5.7|0.9869
73865876|NCT00439374|147277843|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69|||||TWO_SIDED|95.0|0.36|1.3||||||||1.30|0.36|
74030443|NCT02078713|147615162|SUPERIORITY||Odds Ratio (OR)|0.86||||0.26|TWO_SIDED|95.0|0.65|1.12||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the shot (Depo Provera). Patients were excluded from this analysis if they reported not having heard of the the shot (Depo Provera) in the post-visit survey.||1.12|0.65|0.26
73865877|NCT00439374|147277844|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.82|1.15||||||||1.15|0.82|
73865878|NCT00439374|147277845|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.55|1.29||||||||1.29|0.55|
73865879|NCT00439374|147277846|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.77|1.55||||||||1.55|0.77|
73865880|NCT00439374|147277847|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.52|||||TWO_SIDED|95.0|0.43|5.33||||||||5.33|0.43|
73865881|NCT00439374|147277848|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.78|1.72||||||||1.72|0.78|
73865882|NCT00439374|147277849|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.56|2.41||||||||2.41|0.56|
73865883|NCT00439374|147277851|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.34|1.58||||||||1.58|0.34|
73865884|NCT00439374|147277852|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|0.84|2.52||||||||2.52|0.84|
73865885|NCT00439374|147277853|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.79|1.46||||||||1.46|0.79|
73865886|NCT00439374|147277854|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.92|1.13||||||Any side effect||1.13|0.92|
73865887|NCT00439374|147277854|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.93|1.17||||||Injection site||1.17|0.93|
73865888|NCT00439374|147277854|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.03|||||TWO_SIDED|95.0|1.11|22.78||||||Urticaria||22.78|1.11|
73865889|NCT00439374|147277854|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.27|1.83||||||Nausea||1.83|0.27|
73865890|NCT00439374|147277855|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.46|1.3||||||Analysis is for the total composite||1.30|0.46|
73865891|NCT00439374|147277856|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
73865892|NCT00439374|147277864|SUPERIORITY_OR_OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
73865893|NCT01147848|147277866|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.037||||0.162|TWO_SIDED|95.0|-0.088|0.015|||ANCOVA||Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|||0.015|-0.088|0.162
73865894|NCT02540265|147277884|OTHER||Effect Size|1.01|||||TWO_SIDED|||||||||||||
73865895|NCT02540265|147277884|OTHER||Effect Size|0.87|||||TWO_SIDED|||||||||||||
73865896|NCT02540265|147277885|SUPERIORITY|||||||0.0049|||||||t-test, 2 sided|||||||0.0049
73865897|NCT02540265|147277885|SUPERIORITY|||||||0.0076|||||||t-test, 2 sided|||||||0.0076
73865898|NCT02540265|147277886|SUPERIORITY||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided|||||||<0.05
73865899|NCT02540265|147277886|SUPERIORITY||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided|||||||<0.05
73865900|NCT02102399|147277907|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.001
73865901|NCT02102399|147277908|SUPERIORITY_OR_OTHER|||||||0.345|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.345
73865902|NCT02102399|147277909|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
73865903|NCT02102399|147277910|SUPERIORITY_OR_OTHER|||||||0.171|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.171
73865904|NCT02102399|147277911|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.022
73865905|NCT02102399|147277912|SUPERIORITY_OR_OTHER|||||||0.451|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.451
73865906|NCT02102399|147277913|SUPERIORITY_OR_OTHER|||||||0.477|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.477
73865907|NCT02102399|147277914|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.007
73865908|NCT02102399|147277915|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.049
73865909|NCT02102399|147277916|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.323
73865910|NCT02102399|147277917|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.296
73865911|NCT02102399|147277918|SUPERIORITY_OR_OTHER|||||||0.776|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.776
73865912|NCT02102399|147277919|SUPERIORITY_OR_OTHER|||||||0.959|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.959
73865913|NCT02102399|147277920|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.76
73865914|NCT02102399|147277921|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
73865915|NCT02102399|147277922|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.20
73865916|NCT02102399|147277923|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.77
73865917|NCT02102399|147277924|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.49
73865918|NCT02102399|147277925|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.74
73865919|NCT02102399|147277926|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Fisher Exact|||||||0.120
73865920|NCT02102399|147277927|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.030
73865921|NCT02102399|147277928|SUPERIORITY_OR_OTHER|||||||0.107|TWO_SIDED||||||Fisher Exact|||||||0.107
73865922|NCT03101085|147277929|OTHER|We performed a paired T-test analysis to ascertain whether the COX/CS activity while on S-equol was comparable or different than the COX/CS while on placebo. For each participant, the COX/CS value while on S-equol was subtracted from their COX/CS value while on placebo.|||||>|0.05|||||||Paired T-test|||As the order of the intervention does not matter, all 39 participants who contributed data to the final analysis are included together.||||>0.05
73957832|NCT03068468|147451200|SUPERIORITY||Difference|0.5||||0.1763|TWO_SIDED|95.0|-0.2|1.2|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MoCA as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MoCA, baseline MoCA by time interaction,baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.2|-0.2|0.1763
73934375|NCT03893448|147398824|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|2.59|||<|0.001|TWO_SIDED|95.0|2.36|2.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||2.83|2.36|< 0.001
74008322|NCT03627767|147566502|SUPERIORITY||LSM difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-6.1|-4.0|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-4.0|-6.1|< 0.0001
74088824|NCT00484419|147730825|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||<0.0001
73865923|NCT04583956|147277954|SUPERIORITY||Odds Ratio (OR)|0.98||||0.927|TWO_SIDED|95.0|0.59|1.61|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while participants lost to follow-up after discharge to home are assigned a score of 2.||1.61|0.59|0.927
73865924|NCT04583956|147277955|SUPERIORITY||Odds Ratio (OR)|0.9||||0.829|TWO_SIDED|95.0|0.36|2.25|||Regression, Logistic||Odds ratio greater than 1 favors Remdesivir plus Risankizumab.|Odds ratio, confidence interval, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline C-Reactive Protein (CRP).||2.25|0.36|0.829
73865925|NCT04583956|147277956|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.399|TWO_SIDED|95.0|0.84|1.56|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio, confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.56|0.84|0.399
73865926|NCT04583956|147277957|SUPERIORITY||Odds Ratio (OR)|1.03||||0.91|TWO_SIDED|95.0|0.62|1.71|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for those lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.71|0.62|0.910
73865927|NCT04583956|147277958|SUPERIORITY||Odds Ratio (OR)|1.14||||0.617|TWO_SIDED|95.0|0.68|1.93|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for those lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.93|0.68|0.617
73865928|NCT04583956|147277991|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.55|TWO_SIDED|95.0|0.82|1.46|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio (HR), confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.46|0.82|0.550
73865929|NCT04583956|147277992|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.523|TWO_SIDED|95.0|0.82|1.48|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio (HR), confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.48|0.82|0.523
73865930|NCT04016077|147277995|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Geometric Means|118.5|||||TWO_SIDED|90.0|87.96|159.64|||ANOVA|||||159.64|87.96|
73865931|NCT04016077|147277996|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Geometric Means|104.0|||||TWO_SIDED|90.0|74.48|145.23|||ANOVA|||||145.23|74.48|
73865932|NCT03416127|147278005|OTHER|||||||0.031|||||||Kruskal-Wallis|||||||0.031
73865933|NCT03416127|147278006|OTHER|||||||0.963|||||||Kruskal-Wallis|||||||0.963
73865934|NCT03416127|147278007|OTHER|||||||0.236|||||||Kruskal-Wallis|||||||0.236
73865935|NCT03416127|147278008|OTHER|||||||0.015|||||||Kruskal-Wallis|||||||0.015
73865936|NCT03416127|147278009|OTHER|||||||0.017|||||||Kruskal-Wallis|||||||0.017
73865937|NCT03416127|147278010|OTHER|||||||0.162|||||||Kruskal-Wallis|||||||0.162
73865938|NCT03416127|147278011|OTHER|||||||0.686|||||||Kruskal-Wallis|||||||0.686
73865939|NCT03416127|147278012|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
73865940|NCT03416127|147278013|OTHER|||||||0.945|||||||Kruskal-Wallis|||||||0.945
73865941|NCT03416127|147278014|OTHER|||||||0.332|||||||Kruskal-Wallis|||||||0.332
73865942|NCT03416127|147278015|OTHER|||||||0.075|||||||Kruskal-Wallis|||||||0.075
73865943|NCT03416127|147278016|OTHER|||||||0.903|||||||Kruskal-Wallis|||||||0.903
73865944|NCT03416127|147278017|OTHER|||||||0.697|||||||Kruskal-Wallis|||||||0.697
73865945|NCT03416127|147278018|OTHER|||||||0.668|||||||Kruskal-Wallis|||||||0.668
73865946|NCT03416127|147278019|OTHER|||||||0.308|||||||Kruskal-Wallis|||||||0.308
73865947|NCT03416127|147278020|OTHER|||||||0.318|||||||Kruskal-Wallis|||||||0.318
73865948|NCT03416127|147278021|OTHER|||||||0.88|||||||Kruskal-Wallis|||||||0.880
73865949|NCT03416127|147278022|OTHER|||||||0.376|||||||Kruskal-Wallis|||||||0.376
73865950|NCT03416127|147278023|OTHER|||||||0.21|||||||Kruskal-Wallis|||||||0.210
73865951|NCT03416127|147278024|OTHER|||||||0.88|||||||Kruskal-Wallis|||||||0.880
73972366|NCT05565820|147485874|SUPERIORITY|"The nonparametric Mann-Whitney test was also conducted to check on the effect of the non-normality of the change proportions.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.182||0.334|TWO_SIDED|95.0|-0.187|0.543||Alpha = .05 t: .976 df: 54 Mann-Whitney Z: 3.021 p(2-tailed) of Mann-Whitney Z: .003 Cohen's d = .294|t-test, 2 sided|Levine's test for violation of equality of variances nonsignificant; no df adjustment necessary.||"Null hypothesis: At Day 7 the proportion of decrease from baseline in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 7 change proportions deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on their mean change proportions."||.543|-.187|.334
73972367|NCT05565820|147485874|SUPERIORITY|"The nonparametric Mann-Whitney test was also conducted to check on the effect of the non-normality of the change proportions.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Difference between proportions|0.235|STANDARD_ERROR_OF_MEAN|0.1034||0.037|TWO_SIDED|95.0|0.016|0.454||Alpha = .05 t: 2.276 df(adjusted, see comment below): 16.2 Mann-Whitney Z: 2.478 p(2-tailed) of Mann-Whitney Z: .013 Cohen's d = .947|t-test, 2 sided|Degrees of freedom for the t-test were adjusted for inequality of variances between the groups using the Satterthwaite correction: df(adj) = 16.2||"Null hypothesis: At Day 14 the proportion of decrease from baseline in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 14 change proportion deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on the mean change proportions."||.454|.016|.037
73972368|NCT05086796|147485875|SUPERIORITY||Risk Ratio (RR)|2.1|||||TWO_SIDED|97.5|1.51|2.91|||||The START arm is the numerator, Usual Care is the denominator. There are two primary outcome measures, so the type I error level was adjusted to alpha = 0.025.||Poisson regression was used to compare the proportions of participants who initiated MOUD in the hospital by calculating the risk ratio (RR) and 97.5% confidence interval (CI) and with covariates treatment arm, site (3 sites), prior exposure to MOUD (yes vs. no), and length of hospital stay in days.|2.91|1.51|
73972369|NCT05086796|147485876|SUPERIORITY||Risk Ratio (RR)|1.49|||||TWO_SIDED|97.5|1.15|1.93|||||The START arm is the numerator, Usual Care is the denominator. There are two primary outcome measures, so the type I error level was adjusted to alpha = 0.025.||Poisson regression was used to compare the proportions of participants who linked to follow-up OUD care by calculating the risk ratio (RR) and 97.5% confidence interval (CI) and with covariates treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|1.93|1.15|
73972370|NCT05086796|147485877|SUPERIORITY||Risk Ratio (RR)|1.8|||||TWO_SIDED|95.0|1.35|2.41|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who initiated MOUD in the hospital between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|2.41|1.35|
73972371|NCT05086796|147485878|SUPERIORITY||Risk Ratio (RR)|1.71|||||TWO_SIDED|95.0|1.23|2.39|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who reported any post-discharge MOUD utilization between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|2.39|1.23|
74030444|NCT02078713|147615162|SUPERIORITY||Odds Ratio (OR)|0.85||||0.23|TWO_SIDED|95.0|0.64|1.11||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pill. Patients were excluded from this analysis if they reported not having heard of the pill in the post-visit survey.||1.11|0.64|0.23
73865952|NCT03416127|147278025|OTHER|||||||0.059|||||||Kruskal-Wallis|||||||0.059
73865953|NCT03416127|147278026|OTHER|||||||0.978|||||||Kruskal-Wallis|||||||0.978
73865954|NCT03416127|147278027|OTHER|||||||0.122|||||||Kruskal-Wallis|||||||0.122
73865955|NCT03416127|147278028|OTHER|||||||0.551|||||||Kruskal-Wallis|||||||0.551
73865956|NCT01963845|147278035|SUPERIORITY_OR_OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
73865957|NCT01963845|147278036|SUPERIORITY_OR_OTHER|||||||0.7583|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in AST values from baseline to 24 weeks between the two groups.||||0.7583
73865958|NCT01963845|147278037|SUPERIORITY_OR_OTHER|||||||0.8569|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in ALT values from baseline to 24 weeks between the two groups.||||0.8569
73865959|NCT01963845|147278038|SUPERIORITY_OR_OTHER|||||||0.7984|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in LDL values from baseline to 24 weeks between the two groups.||||0.7984
73865960|NCT01963845|147278039|SUPERIORITY_OR_OTHER|||||||0.556|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in HOMA-IR values from baseline to 24 weeks between the two groups.||||0.5560
73865961|NCT00858208|147278043|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED||||||paired t-test|||||||0.0072
73865962|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.0433|TWO_SIDED||||||paired t-test|||Change from baseline at Week 6||||0.0433
73865963|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.0133|TWO_SIDED||||||paired t-test|||Change from baseline at Week 12||||0.0133
73865964|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||paired t-test|||Change from baseline at Week 18||||0.0278
73865965|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||paired t-test|||Change from baseline at Week 24||||0.0160
73865966|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED||||||paired t-test|||Change from baseline at Week 30||||0.0264
73865967|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||paired t-test|||Change from baseline at Week 36||||0.0278
73865968|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.1854|TWO_SIDED||||||paired t-test|||Change from baseline at Week 42||||0.1854
73865969|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.1684|TWO_SIDED||||||paired t-test|||Change from baseline at Week 48||||0.1684
73865970|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.4718|TWO_SIDED||||||paired t-test|||Change from baseline at Week 54||||0.4718
73865971|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||paired t-test|||Change from baseline at Week 60||||0.4340
73934376|NCT03893448|147398825|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-2.6|1.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Diphtheria toxoid % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.1|-2.6|< 0.001
73934377|NCT03893448|147398825|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.4|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Tetanus toxoid: % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-0.4|< 0.001
73934378|NCT03893448|147398825|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|0.5|||<|0.001|TWO_SIDED|95.0|-0.7|1.9||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis toxin (PT): % ≥ 5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.9|-0.7|< 0.001
73934379|NCT03893448|147398825|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-1.3|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-1.3|< 0.001
73934380|NCT03893448|147398825|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|2.0|||<|0.001|TWO_SIDED|95.0|-3.1|7.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||7.1|-3.1|< 0.001
73934381|NCT03893448|147398825|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|1.8|||<|0.001|TWO_SIDED|95.0|-3.2|6.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis pertactin (PRN): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||6.8|-3.2|< 0.001
73865972|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.7765|TWO_SIDED||||||paired t-test|||Change from baseline at Week 66||||0.7765
73865973|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.7544|TWO_SIDED||||||paired t-test|||Change from baseline at Week 72||||0.7544
73865974|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.7201|TWO_SIDED||||||paired t-test|||Change from baseline at Week 84||||0.7201
73865975|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.5692|TWO_SIDED||||||paired t-test|||Change from baseline at Week 90||||0.5692
73865976|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED||||||paired t-test|||Change from baseline at Week 96||||0.2749
73865977|NCT00858208|147278044|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED||||||paired t-test|||Change from baseline at Week 102||||0.2749
73865978|NCT00858208|147278046|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED||||||paired t-test|||Change at Month 6||||0.2970
73865979|NCT00858208|147278046|SUPERIORITY_OR_OTHER|||||||0.1392|TWO_SIDED||||||paired t-test|||Change at Month 12||||0.1392
73865980|NCT00858208|147278046|SUPERIORITY_OR_OTHER|||||||0.0573|TWO_SIDED||||||paired t-test|||Change at Month 18||||0.0573
73865981|NCT00858208|147278046|SUPERIORITY_OR_OTHER|||||||0.7625|TWO_SIDED||||||paired t-test|||Change at Month 24||||0.7625
73865982|NCT00858208|147278047|SUPERIORITY_OR_OTHER|||||||0.2759|TWO_SIDED||||||paired t-test|||||||0.2759
73865983|NCT02702180|147278057|SUPERIORITY||Least Square Means (LSmean)|-4.6||||0.1688|TWO_SIDED|95.0|-11.1|2.0|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|Primary endpoint was evaluated using analysis of covariance with treatment, whole lung lavage within 2 months before baseline, and geographic region as factors, and baseline values as covariates. To control type I error, key secondary endpoints were analyzed using a testing hierarchy wherein once daily molgramostim and placebo was compared and if statistical significance was reached, evaluation of intermittent molgramostim and placebo would proceed.||2.0|-11.1|0.1688
73865984|NCT02702180|147278057|SUPERIORITY||Least Square Means (LSmean)|-2.8||||0.3968|TWO_SIDED|95.0|-9.3|3.7|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24.|||3.7|-9.3|0.3968
73865985|NCT02702180|147278058|SUPERIORITY||Least Square Means (LSmean)|20.6||||0.3159|TWO_SIDED|95.0|-19.8|61.0|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|||61.0|-19.8|0.3159
73865986|NCT02702180|147278058|SUPERIORITY||Least Square Means (LSmean)|5.6||||0.7809|TWO_SIDED|95.0|-34.1|45.2|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24.|||45.2|-34.1|0.7809
73934382|NCT03893448|147398825|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 1: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-0.7|< 0.001
73934383|NCT03893448|147398825|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.6|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 2: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.6|-0.6|< 0.001
73934384|NCT03893448|147398825|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.6|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 3: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.6|-0.6|< 0.001
73934385|NCT03893448|147398825|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-4.3|1.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.5|-4.3|< 0.001
73934386|NCT03893448|147398826|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.09|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - PT GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.09|0.89|< 0.001
73934387|NCT03893448|147398826|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.98|||<|0.001|TWO_SIDED|95.0|0.87|1.09|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - FHA GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.09|0.87|< 0.001
73934388|NCT03893448|147398826|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.08|||<|0.001|TWO_SIDED|95.0|0.91|1.28|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - FIM 2/3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.28|0.91|< 0.001
73934389|NCT03893448|147398826|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.0|||<|0.001|TWO_SIDED|95.0|0.84|1.19|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - PRN GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.19|0.84|< 0.001
73934390|NCT03893448|147398827|NON_INFERIORITY|A conclusion of non-inferiority of VAQTA™ administered concomitantly with V114 to VAQTA™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-1.6|2.2||p value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||2.2|-1.6|< 0.001
73972372|NCT05086796|147485879|SUPERIORITY||Risk Ratio (RR)|1.89|||||TWO_SIDED|95.0|1.18|3.03|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who reported receiving any post-discharge outpatient medical care for their OUD between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: site (3 sites), and prior exposure to MOUD (yes vs. no).|3.03|1.18|
73934391|NCT03893448|147398828|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.8|1.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Measles antigen ≥255 mIU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.3|-1.8|< 0.001
73972373|NCT05086796|147485880|SUPERIORITY||Incident rate ratio|1.25|||||TWO_SIDED|95.0|0.64|2.43|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable negative binomial regression with a log link function was used to compare opioid use-days between the two treatment arms by calculating the incident rate ratio (IRR) and 95% confidence interval (CI) with covariates: site (3 sites), prior exposure to MOUD (yes vs. no), and baseline opioid use days.|2.43|0.64|
73934392|NCT03893448|147398828|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-3.8|0.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Mumps antigen ≥10 mumps Ab units/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.2|-3.8|< 0.001
73934393|NCT03893448|147398828|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.3|0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Rubella antigen ≥10 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.5|-2.3|< 0.001
73934394|NCT03893448|147398829|NON_INFERIORITY|A conclusion of non-inferiority of VARIVAX™ administered concomitantly with V114 to VARIVAX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-3.2|0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.5|-3.2|< 0.001
73934395|NCT03893448|147398830|NON_INFERIORITY|A conclusion of non-inferiority of HIBERIX™ administered concomitantly with V114 to HIBERIX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-2.2|-0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||-0.5|-2.2|< 0.001
73934396|NCT03893448|147398831|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|92.03|||<|0.001|TWO_SIDED|95.0|83.47|101.47|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||101.47|83.47|< 0.001
73934397|NCT03893448|147398831|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|29.5|||<|0.001|TWO_SIDED|95.0|26.16|33.26|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||33.26|26.16|< 0.001
73934398|NCT03893448|147398832|SUPERIORITY||Percentage Point Difference|95.1|||<|0.001|TWO_SIDED|95.0|93.1|96.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 22F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||96.5|93.1|< 0.001
73934399|NCT03893448|147398832|SUPERIORITY||Percentage Point Difference|85.2|||<|0.001|TWO_SIDED|95.0|82.3|87.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 33F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||87.7|82.3|< 0.001
73934400|NCT03893448|147398833|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|68.8|||<|0.001|TWO_SIDED|95.0|63.1|75.02|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||75.02|63.10|< 0.001
73972374|NCT03295721|147485881|SUPERIORITY||Least Squares Mean Difference (LSMD)|-122.05|STANDARD_ERROR_OF_MEAN|21.217|<|0.0001|TWO_SIDED|95.0|-163.76|-80.34|||ANOVA|||||-80.34|-163.76|< 0.0001
73934401|NCT03893448|147398833|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|44.91|||<|0.001|TWO_SIDED|95.0|41.04|49.14|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||49.14|41.04|< 0.001
73934402|NCT03893448|147398836|SUPERIORITY||Percentage Point Difference|15.6|||<|0.001|TWO_SIDED|95.0|12.1|19.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method||19.2|12.1|< 0.001
73934403|NCT03893448|147398837|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|1.73|||<|0.001|TWO_SIDED|95.0|1.61|1.87|||t-test, 1 sided||V114/Prevnar 13™|GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.87|1.61|< 0.001
73934404|NCT03893448|147398838|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|1.35|||<|0.001|TWO_SIDED|95.0|1.25|1.46|||t-test, 1 sided||V114/Prevnar 13™|GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.46|1.25|< 0.001
73934405|NCT01418209|147398906|SUPERIORITY_OR_OTHER|||||||0.02||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.02
73972375|NCT03295721|147485882|SUPERIORITY||Least Squares Mean Difference (LSMD)|-70.16|STANDARD_ERROR_OF_MEAN|18.777|=|0.0002|TWO_SIDED|95.0|-107.07|-33.25|||ANOVA|||||-33.25|-107.07|= 0.0002
73972376|NCT03295721|147485883|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
73972377|NCT03295721|147485884|SUPERIORITY||Risk Difference (RD)|0.177||||0.0001|TWO_SIDED|95.0|0.085|0.265|||Fisher Exact|||||.265|.085|0.0001
73972378|NCT03295721|147485885|SUPERIORITY||||||=|0.0022|||||||Wilcoxon (Mann-Whitney)|||||||= 0.0022
74088825|NCT00484419|147730826|SUPERIORITY_OR_OTHER|||||||0.0234||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0234
73934406|NCT01418209|147398906|SUPERIORITY_OR_OTHER|||||||0.02||||||p-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold of statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.02
73934407|NCT01418209|147398907|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.||||<0.001
73972379|NCT05012163|147485934|SUPERIORITY|||||||0.506||||||Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket and patients sent messages offering $1 cash in exchange for vaccination; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those sent messages offering $1 cash.||||.506
73972380|NCT05012163|147485934|SUPERIORITY|||||||0.378||||||Comments: Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket in exchange for vaccination and those sent active control messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those sent active control messages.||||0.378
73972381|NCT05012163|147485934|SUPERIORITY||||||<|0.001||||||Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket in exchange for vaccination and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those who were not sent messages.||||<.001
73972382|NCT05012163|147485934|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent active control messages and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent active control messages compared to those who were not sent messages.||||<.001
73972383|NCT05012163|147485934|SUPERIORITY|Pairwise comparisons between patients offered cash for vaccination and those in active or passive control (Analyses 5 and 6) were analyzed in the same regression.||||||0.121|||||||Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering $1 cash in exchange for vaccination and those sent active control messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering $1 cash compared to those sent active control messages.||||.121
73972384|NCT05012163|147485934|SUPERIORITY|||||||0.002||||||Pairwise comparisons between patients offered cash for vaccination and those in active or passive control (Analyses 5 and 6) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering $1 cash in exchange for vaccination and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering $1 cash compared to those who were not sent messages.||||.002
73972385|NCT03213873|147485982|SUPERIORITY||Interaction effect time x group|0.4||||0.57|TWO_SIDED|95.0|-1.0|1.9|||Mixed Models Analysis|||||1.9|-1.0|0.57
73972386|NCT03213873|147485983|SUPERIORITY||Interaction effect time x group|0.05||||0.25|TWO_SIDED|95.0|-0.03|0.12|||Mixed Models Analysis|||||0.12|-0.03|0.25
73972387|NCT03213873|147485984|SUPERIORITY||Interaction effect time x group|0.2||||0.75|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|0.75
73972388|NCT02361216|147485995|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|6.29|||<|0.001|TWO_SIDED|95.0|2.82|14.0|||Cochran-Mantel-Haenszel|||AKclear100 at Week 8: full analysis set. The null hypothesis was that there is no difference at Week 8 in AKclear100 rates between ingenol mebutate gel 0.027% and vehicle gel. This hypothesis was tested against the 2-sided alternative of a difference between the 2 treatment groups.||14|2.82|<0.001
73972389|NCT02361216|147485996|SUPERIORITY||Ratio of clearance rates|6.81|||<|0.001|TWO_SIDED|95.0|4.16|11.1|||Cochran-Mantel-Haenszel||Mantel-Haenszel estimate (0.027% relative to vehicle), adjusted for pooled sites|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||11.1|4.16|<0.001
73972390|NCT02361216|147485997|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|6.53|||<|0.001|TWO_SIDED|95.0|4.04|10.5|||Mantel Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The pre-specified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.5|4.04|<0.001
73972391|NCT02361216|147485998|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance|0.28|||<|0.001|TWO_SIDED|95.0|0.24|0.32||Negative binominal regression with log baseline count as offset variable and treatment group, anatomical location stratum and pooled site as factors.|Cochran-Mantel-Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.32|0.24|<0.001
73972392|NCT02668692|147486031|SUPERIORITY||Odds Ratio (OR)|1.96|||=|0.68|TWO_SIDED|95.0|0.35|10.95|||Fisher Exact|||Statistical analysis of the FAS.||10.95|0.35|=0.68
74039403|NCT04847141|147632409|SUPERIORITY||Difference in Percentage|1.9||||0.6463|TWO_SIDED|95.0|-6.5|10.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 29||10.3|-6.5|0.6463
73865987|NCT02702180|147278059|SUPERIORITY||Least Square Means (LSmean)|-7.6||||0.0103|TWO_SIDED|95.0|-13.4|-1.8|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|||-1.8|-13.4|0.0103
73865988|NCT02702180|147278059|SUPERIORITY||Least Square Means (LSmean)|-7.0||||0.0173|TWO_SIDED|95.0|-12.7|-1.3|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24..|||-1.3|-12.7|0.0173
73865989|NCT02702180|147278060|SUPERIORITY||Risk Ratio (RR)|0.284||||0.1918|TWO_SIDED|95.0|0.043|1.881|||Negative binomial regression||The estimated value represents the RR between once daily molgramostim and placebo groups.|||1.881|0.043|0.1918
73934408|NCT01418209|147398907|SUPERIORITY_OR_OTHER|||||||0.005||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.||||0.005
73934409|NCT01418209|147398909|SUPERIORITY_OR_OTHER|||||||0.01||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.01
73934410|NCT01418209|147398909|SUPERIORITY_OR_OTHER|||||||0.07||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.07
73972393|NCT02668692|147486031|SUPERIORITY||Odds Ratio (OR)|1.92|||=|0.68|TWO_SIDED|95.0|0.34|10.72||Treatment comparison by Fisher's exact test.|Fisher Exact||Odds of 'overall improvement' in LEO 80185 gel group relative to Dovobet® ointment group.|Statistical analysis of the PPAS.||10.72|0.34|=0.68
73972394|NCT02668692|147486032|SUPERIORITY||Odds Ratio (OR)|0.28|||=|0.009|TWO_SIDED|95.0|0.11|0.74|||Fisher Exact|||Statistical analysis for the FAS.||0.74|0.11|=0.009
73972395|NCT02668692|147486032|SUPERIORITY||Odds Ratio (OR)|0.22|||=|0.003|TWO_SIDED|95.0|0.08|0.63||Treatment comparison by Fisher's exact test.|Fisher Exact||Odds of 'overall improvement' in LEO 80185 gel group relative to Dovobet® ointment group.|Statistical analysis of the PPAS.||0.63|0.08|=0.003
73972396|NCT01627574|147486057|SUPERIORITY||Risk Ratio, log|0.281|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|95.0|0.056|1.42|||Chi-squared, Corrected|||||1.42|.056|>.05
73972397|NCT03308877|147486066|OTHER|||||||0.07||||||Covariates include education \& percent days abstinent at baseline.|Regression, Linear|||Hypothesis 1: Affective psychopathy scores will moderate response to a BMI such that individuals with lower scores will benefit relative to controls, but individuals with higher psychopathy scores will not benefit from the intervention in terms of percent days abstinent.||||.07
73934411|NCT01418209|147398911|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo.||||<0.001
73934412|NCT01418209|147398911|SUPERIORITY_OR_OTHER|||||||0.03||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.03
73972398|NCT03308877|147486066|OTHER|||||||0.02|||||||Regression, Linear|||Sensitivity analysis: proximal follow-up (3 months following BMI or SC)||||.02
73972399|NCT03308877|147486066|OTHER||B|0.063|||<|0.01|TWO_SIDED|95.0|0.007|0.156|||Regression, Linear|bias corrected bootstrap||Increased readiness to change will be associated with decreased substance use.||.156|.007|<.01
73972400|NCT03308877|147486067|OTHER|||||||0.74|||||||Regression, Linear|||||||.74
73972401|NCT03308877|147486068|OTHER|||||||0.88|||||||Regression, Logistic|||||||.88
73972402|NCT05233800|147486069|SUPERIORITY||Mean Difference (Net)|5.83|||<|0.05|TWO_SIDED|95.0|3.84|7.81|||Mixed Models Analysis|||||7.81|3.84|<0.05
74008323|NCT03627767|147566502|SUPERIORITY||LSM difference|-6.6|||<|0.0001|TWO_SIDED|95.0|-7.6|-5.5|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.5|-7.6|< 0.0001
73865990|NCT02702180|147278060|SUPERIORITY||Risk Ratio (RR)|0.367||||0.2421|TWO_SIDED|95.0|0.068|1.968|||Negative binomial regression||The estimated value represents the RR between intermittent molgramostim and placebo groups.|||1.968|0.068|0.2421
73865991|NCT00793325|147278085|SUPERIORITY_OR_OTHER||||||=|0.575|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<15 years and \>=15 years in the frequency of treatment related adverse events."||||=0.575
73865992|NCT00793325|147278086|SUPERIORITY_OR_OTHER||||||=|0.206|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."||||=0.206
73865993|NCT00793325|147278087|SUPERIORITY_OR_OTHER||||||=|0.033|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Severity. The null hypothesis is that there is no association between mild, moderate and severe in the frequency of treatment related adverse events."||||=0.033
73865994|NCT00793325|147278087|SUPERIORITY_OR_OTHER||||||=|0.207|TWO_SIDED||||||Cochran-Armitage Exact|||"The risk factor tested was Severity. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of severity."||||=0.207
73934413|NCT01971346|147398922|OTHER|||||||0.38||||||Type III TNF-alpha p-value=0.36. Type III IFN-alpha p-value=0.36. Interaction was not included in this model.|Regression, Linear|||A cumulative score reflecting change in PASI during the course of treatment was calculated and treated as a continuous response variable. Linear modeling was done to determine if change in PASI score was associated with the baseline TNF-alpha signal, baseline IFN-alpha signal and/or an interaction between these two signals.||||0.38
73934414|NCT01971346|147398923|OTHER|||||||0.03||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.03 Test of Hypotheses for Within subject effect of Time p-value=0.38 Test of Hypotheses for Within subject effect of Time\*PASI profile p-value=0.31|ANOVA|||The strength of the TNF-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if TNF-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.||||0.03
73934415|NCT01971346|147398924|OTHER|||||||0.34||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.34 Test of Hypotheses for Within subject effect of Time p-value=0.73 Test of Hypotheses for Within subject effect of Time\*PASI profile p-value=0.57|ANOVA|||The strength of the IFN-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if IFN-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.||||0.34
73934416|NCT04737538|147398926|OTHER||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-13.3|-8.8|||Non-parametric method (Van Elteren test)|||||-8.8|-13.3|<0.0001
73934417|NCT04737538|147398927|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.01||0.4488|TWO_SIDED|95.0|-1.6|2.4|||Non-parametric method (Van Elteren test)|||||2.4|-1.6|0.4488
73934418|NCT04737538|147398928|OTHER||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|1.18|<|0.0001|TWO_SIDED|95.0|-13.8|-9.1|||Non-parametric method (Van Elteren test)|||||-9.1|-13.8|<0.0001
73934419|NCT04666441|147398938|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.16||0.0004|TWO_SIDED|95.0|-0.88|-0.25|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.25|-0.88|0.0004
73934420|NCT04666441|147398938|SUPERIORITY||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-0.99|-0.34|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.34|-0.99|<0.0001
73934421|NCT04666441|147398938|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.89|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.89|0.0007
73934422|NCT04666441|147398938|SUPERIORITY||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.38|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.38|-1.05|<0.0001
74039404|NCT04847141|147632410|SUPERIORITY|||||||0.9033|||||||Log Rank|||||||0.9033
73934423|NCT04666441|147398938|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0006||95.0|-0.88|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.88|0.0006
73934424|NCT04666441|147398938|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007||95.0|-0.87|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.87|0.0007
73934425|NCT04666441|147398939|SUPERIORITY||Difference of LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0002||95.0|-0.72|-0.23|||ANCOVA|||||-0.23|-0.72|0.0002
73934426|NCT04666441|147398939|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.82|-0.32|||ANCOVA|||||-0.32|-0.82|<0.0001
73934427|NCT04666441|147398939|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.83|-0.33|||ANCOVA|||||-0.33|-0.83|<0.0001
73934428|NCT04666441|147398939|SUPERIORITY||Difference of LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.13||0.0002||95.0|-0.75|-0.24|||ANCOVA|||||-0.24|-0.75|0.0002
73934429|NCT04666441|147398939|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.004||95.0|-0.62|-0.12|||ANCOVA|||||-0.12|-0.62|0.0040
73934430|NCT04666441|147398939|SUPERIORITY||Difference of LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.12||0.0007||95.0|-0.67|-0.18|||ANCOVA|||||-0.18|-0.67|0.0007
73934431|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.33|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.82|<0.0001
73934432|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.40|-0.90|<0.0001
73934433|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.42|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.42|-0.97|<0.0001
73934434|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.19|-0.58|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.58|-1.19|<0.0001
73934435|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.84|-0.33|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.84|<0.0001
73934436|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.95|-0.43|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.43|-0.95|<0.0001
73934437|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.98|-0.44|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.44|-0.98|<0.0001
73934438|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.64|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.64|-1.25|<0.0001
73934439|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.87|-0.37|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.37|-0.87|<0.0001
73934440|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.93|-0.42|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.42|-0.93|<0.0001
74039405|NCT04847141|147632410|SUPERIORITY|||||||0.5456|||||||Log Rank|||||||0.5456
73865995|NCT00793325|147278088|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Past history of any disease. The null hypothesis is that there is no difference between With past history of any disease and Without past history any disease in the frequency of treatment related adverse events."||||=0.013
73865996|NCT00793325|147278089|SUPERIORITY_OR_OTHER||||||=|0.009|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Complication(s). The null hypothesis is that there is no difference between With complication(s) and Without complication(s)in the frequency of treatment related adverse events."||||=0.009
73865997|NCT00793325|147278090|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Hepatic Function Disorder. The null hypothesis is that there is no difference between with Hepatic Function Disorder and without Hepatic Function Disorder in the frequency of treatment related adverse events."||||<0.001
73865998|NCT00793325|147278091|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Renal Impairment. The null hypothesis is that there is no difference between With Renal Impairment and Without Renal Impairment in the frequency of treatment related adverse events."||||<0.001
73865999|NCT00793325|147278092|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Concomitant Drug(s). The null hypothesis is that there is no difference between With Concomitant Drug(s) and Without Concomitant Drug(s) in the frequency of treatment related adverse events."||||=0.003
73934441|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.99|-0.44|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.44|-0.99|<0.0001
73934442|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.93|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.61|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.61|-1.25|<0.0001
73934443|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.31|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.31|-0.80|<0.0001
73934444|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.89|-0.38|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.38|-0.89|<0.0001
73934445|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.43|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.43|-0.97|<0.0001
73972403|NCT05163496|147486131|SUPERIORITY||Mean Difference (Net)|12.0|STANDARD_DEVIATION|0.8|<|0.001|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis was that the mean change in MADRS score from the preparation 1 session to day 28 would be the same in both niacin and psilocybin groups. The alternative hypothesis was that the change in the psilocybin group would be greater than the change in the niacin group, with an assumed true effect size of 1.06 SD units based on findings in prior studies. With 15 participants per group, this study had 80% power to observe a statistically significant difference between groups.||||<.001
73972404|NCT03655028|147486167|SUPERIORITY|||||||0.85||||||The co-variate used in the analysis was the 6 minute walk distance at baseline.|ANCOVA|||||||0.85
73866000|NCT00793325|147278093|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at one year and SGA at baseline.||||<0.001
73866001|NCT00793325|147278093|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at two years and SGA at baseline.||||<0.001
73866002|NCT00793325|147278093|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at three years and SGA at baseline.||||<0.001
73866003|NCT00793325|147278094|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at one year and SGA at baseline.||||<0.001
73866004|NCT00793325|147278094|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at two years and SGA at baseline.||||<0.001
73866005|NCT00793325|147278094|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at three years and SGA at baseline.||||<0.001
73934446|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.52|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.52|-1.15|<0.0001
73934447|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.76|-0.27|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.27|-0.76|<0.0001
73934448|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.83|-0.33|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.83|<0.0001
73934449|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.82|-0.28|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.28|-0.82|<0.0001
73934450|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.95|-0.32|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.32|-0.95|<0.0001
73934451|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.73|-0.23|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.73|0.0002
73934452|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.31|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.31|-0.82|<0.0001
73866006|NCT01815840|147278102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|||||TWO_SIDED|95.0|-22.2|5.7|||||Asymptotic confidence intervals are presented for the difference between treatment arms.|The mean difference in the mean relative reduction between treatment arms, along with the corresponding 95% confidence interval, was estimated by fitting an ANCOVA model with treatment as main effect and the following covariates: number of basal cell carcinomas at baseline, geographical region, immunosuppression status, confirmed basal cell carcinoma nevus syndrome.||5.7|-22.2|
73866007|NCT00434642|147278146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.484|||<|0.0001|TWO_SIDED|95.0|0.388|0.605||A P-value \< 0.05 was required for significance.|Log Rank|The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.|The null hypothesis was that there was no difference between the 2 treatment groups, ie, that the hazard ratio is equal to 1. The alternative hypothesis was that progression free survival was longer in the carboplatin and gemcitabine + bevacizumab group, ie, that the hazard ratio is not equal to 1.||0.605|0.388|<0.0001
73972405|NCT03655028|147486168|SUPERIORITY|||||||0.307||||||The co-variant used to adjust the ANCOVA was the baseline step count/day.|ANCOVA|||||||.307
74088826|NCT00484419|147730826|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||<0.0001
73934453|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.33|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.87|<0.0001
73972406|NCT03655028|147486169|SUPERIORITY|||||||0.106||||||this comparison is made between distance walked during 6MW at 12 weeks and distance walked during 6MW at 24 weeks|ANCOVA|||||||0.106
73972407|NCT03655028|147486170|SUPERIORITY|||||||0.26||||||Baseline PCS score was used at the co-variate|ANCOVA|||||||0.26
73972408|NCT03655028|147486171|SUPERIORITY|||||||0.85||||||Covariate was baseline MCS score|ANCOVA|||||||0.85
73972409|NCT03655028|147486172|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||||||0.025
73972410|NCT05618587|147486186|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
73972411|NCT05618587|147486187|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
73934454|NCT04666441|147398940|SUPERIORITY||Difference of LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.16|-0.52|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.52|-1.16|<0.0001
73934455|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.12||0.0005|TWO_SIDED|95.0|-0.64|-0.18|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.18|-0.64|0.0005
73934456|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.46|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.23|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.69|<0.0001
73934457|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.75|-0.26|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.26|-0.75|<0.0001
73934458|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.88|-0.32|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.32|-0.88|<0.0001
73934459|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.12||0.0003|TWO_SIDED|95.0|-0.69|-0.21|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.21|-0.69|0.0003
73934460|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.53|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.77|-0.29|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.77|<0.0001
73934461|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.53|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.78|-0.29|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.78|<0.0001
73934462|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.98|-0.41|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.41|-0.98|<0.0001
73934463|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.72|-0.25|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.25|-0.72|<0.0001
73934464|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.74|-0.28|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.28|-0.74|<0.0001
73934465|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.79|-0.3|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.30|-0.79|<0.0001
73934466|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.4|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.40|-0.99|<0.0001
73934467|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0009|TWO_SIDED|95.0|-0.63|-0.16|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.16|-0.63|0.0009
73934468|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|95.0|-0.69|-0.23|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.69|0.0001
73934469|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.77|-0.27|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.27|-0.77|<0.0001
73934470|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.92|-0.34|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.34|-0.92|<0.0001
73934471|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.0046|TWO_SIDED|95.0|-0.57|-0.1|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.10|-0.57|0.0046
74088827|NCT00484419|147730826|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0011
74088828|NCT00484419|147730829|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0077
74088829|NCT00484419|147730829|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0004
73934472|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.62|-0.15|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.15|-0.62|0.0011
73934473|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.0029|TWO_SIDED|95.0|-0.62|-0.13|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.13|-0.62|0.0029
73934474|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.012|TWO_SIDED|95.0|-0.66|-0.08|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.08|-0.66|0.0120
73934475|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0062|TWO_SIDED|95.0|-0.56|-0.09|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.09|-0.56|0.0062
73934476|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.62|-0.16|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.16|-0.62|0.0011
73934477|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.13||0.0011|TWO_SIDED|95.0|-0.66|-0.17|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.17|-0.66|0.0011
73934478|NCT04666441|147398941|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.15||0.0001|TWO_SIDED|95.0|-0.87|-0.29|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.87|0.0001
73934479|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.007||95.0|-0.85|-0.14|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.14|-0.85|0.0070
73934480|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.06|-0.33|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.33|-1.06|0.0002
73934481|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.19||0.0008||95.0|-1.0|-0.26|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.26|-1.00|0.0008
73934482|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.19||0.0125||95.0|-0.85|-0.1|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.10|-0.85|0.0125
73934483|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.0696||95.0|-0.7|0.03|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||0.03|-0.70|0.0696
73972412|NCT05618587|147486188|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
73972413|NCT05618587|147486189|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
73972414|NCT05618587|147486190|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
73972415|NCT05618587|147486191|SUPERIORITY|||||||1|||||||Barnard unconditional exact test|||||||1.0
73934484|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0187|TWO_SIDED|95.0|-0.79|-0.07|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.07|-0.79|0.0187
73934485|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.96|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.39|-0.52|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.52|-1.39|<0.0001
73934486|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-1.09|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.53|-0.64|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.64|-1.53|<0.0001
73934487|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-1.03|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.48|-0.59|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.59|-1.48|<0.0001
73934488|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.5|-0.6|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.60|-1.50|<0.0001
73934489|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.46|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.46|-1.34|<0.0001
73934490|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.92|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.35|-0.48|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.48|-1.35|<0.0001
73934491|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.22||0.0004||95.0|-1.23|-0.35|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.35|-1.23|0.0004
73972416|NCT05618587|147486192|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
73972417|NCT05618587|147486193|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
73972418|NCT05618587|147486194|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
73972419|NCT05618587|147486195|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
73972420|NCT05618587|147486196|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
73972421|NCT05618587|147486197|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
74088830|NCT00484419|147730829|SUPERIORITY_OR_OTHER|||||||0.0483||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0483
74088831|NCT00484419|147730830|SUPERIORITY_OR_OTHER|||||||0.0133||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0133
74088832|NCT00484419|147730830|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0004
73934492|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0058||95.0|-1.08|-0.18|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.18|-1.08|0.0058
74030445|NCT02078713|147615162|SUPERIORITY||Odds Ratio (OR)|0.92||||0.55|TWO_SIDED|95.0|0.69|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the patch. Patients were excluded from this analysis if they reported not having heard of the patch in the post-visit survey.||1.22|0.69|0.55
73934493|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0046||95.0|-1.11|-0.2|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.20|-1.11|0.0046
73934494|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.23||0.0019||95.0|-1.18|-0.27|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.27|-1.18|0.0019
73934495|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.33|-0.44|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.44|-1.33|<0.0001
73934496|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.0079||95.0|-1.04|-0.16|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.16|-1.04|0.0079
73934497|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.23||0.0515||95.0|-0.9|0.0|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.00|-0.90|0.0515
73934498|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.23||0.1864||95.0|-0.77|0.15|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.15|-0.77|0.1864
73934499|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.24||0.2866||95.0|-0.72|0.21|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.21|-0.72|0.2866
73934500|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.11|STANDARD_ERROR_OF_MEAN|0.24||0.647||95.0|-0.58|0.36|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.36|-0.58|0.6470
73934501|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.23||0.028||95.0|-0.97|-0.06|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||-0.06|-0.97|0.0280
73934502|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.23||0.0854||95.0|-0.84|0.05|||Mixed Models Analysis|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.05|-0.84|0.0854
73934503|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.1078|TWO_SIDED|95.0|-0.69|0.07|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.07|-0.69|0.1078
73934504|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.2235||95.0|-0.62|0.14|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.14|-0.62|0.2235
73934505|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.2||0.1369||95.0|-0.68|0.09|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.09|-0.68|0.1369
73934506|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.661||95.0|-0.48|0.31|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.31|-0.48|0.6610
73934507|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.0284||95.0|-0.81|-0.05|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||-0.05|-0.81|0.0284
73934508|NCT04666441|147398945|SUPERIORITY||Difference of LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.08||95.0|-0.71|0.04|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.04|-0.71|0.0800
73934509|NCT03285477|147398956|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 complete clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
73934510|NCT03285477|147398957|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 partial clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
73934511|NCT04286594|147398985|OTHER|Change in single group over time|Mean Difference (Final Values)|11.667|STANDARD_DEVIATION|5.051|<|0.001|TWO_SIDED|95.0|8.457|14.876|||t-test, 1 sided|||||14.876|8.457|<0.001
73934512|NCT05955560|147398986|SUPERIORITY|||||||0.04||||||A two-sided paired t-test was used and p-value derived. The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||||0.04
73934513|NCT00822510|147399057|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<.05
73934514|NCT00822510|147399059|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|0.79|||||ANOVA|||||||.79
73934515|NCT00822510|147399060|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|0.001|||||ANOVA|||||||.001
73934516|NCT00822510|147399061|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|0.001|||||ANOVA|||||||.001
73934517|NCT00822510|147399062|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|0.71|||||ANOVA|||||||.71
73934518|NCT00822510|147399063|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|0.01|||||ANOVA|||||||.01
73934519|NCT03794089|147399064|SUPERIORITY|||||||0.035||||||a priori threshold for statistical significance was p\<=.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline GAD-7 total scores||||0.035
73934520|NCT03794089|147399065|SUPERIORITY|||||||0.231||||||a priori threshold for statistical significance was p\<=0.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline PHQ-9 total scores||||0.231
73934521|NCT03794089|147399066|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.393||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 4 weeks||||0.393
73934522|NCT03794089|147399066|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.022||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 8 weeks||||0.022
73934523|NCT03794089|147399066|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.013||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 12 weeks||||0.013
73972422|NCT05167864|147486199|SUPERIORITY|||||||0.13519|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.13519
73972423|NCT05167864|147486199|SUPERIORITY|||||||0.8556|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.8556
73972424|NCT05167864|147486199|SUPERIORITY|||||||0.46943|TWO_SIDED|95.0|||||Wilcoxon signed-rank test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.46943
73972425|NCT05167864|147486199|SUPERIORITY|||||||0.0449|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.0449
73972426|NCT05167864|147486199|SUPERIORITY|||||||0.504|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.504
73972427|NCT05167864|147486199|SUPERIORITY|||||||0.772193|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.772193
73972428|NCT05167864|147486199|SUPERIORITY|||||||0.5414|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.5414
73972429|NCT05167864|147486199|SUPERIORITY|||||||0.07|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.070
73972430|NCT05167864|147486199|SUPERIORITY|||||||0.546|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.546
73972431|NCT05167864|147486199|SUPERIORITY|||||||0.756|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.756
73972432|NCT05167864|147486199|SUPERIORITY|||||||0.7|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.700
73972433|NCT05167864|147486199|SUPERIORITY|||||||0.397|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.397
73972434|NCT05167864|147486199|SUPERIORITY|||||||0.093|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.093
73972435|NCT05167864|147486199|SUPERIORITY|||||||0.323|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.323
73972436|NCT05167864|147486199|SUPERIORITY|||||||0.182|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement of line in the forehead post injection day 180|||0.182
74039406|NCT04847141|147632411|SUPERIORITY||Difference in Percentage|0.79||||0.6311|TWO_SIDED|95.0|-2.9|4.6||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required oxygen supplementation between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between each of 1 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.|||4.6|-2.9|0.6311
73934524|NCT03794089|147399066|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.049||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to Post assessment (16 weeks)||||0.049
73934525|NCT03794089|147399067|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.008||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 4 weeks||||0.008
73934526|NCT03794089|147399067|SUPERIORITY|Testing null hypothesis of no difference between groups|||||<|0.001||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 8 weeks||||<0.001
73934527|NCT03794089|147399067|SUPERIORITY|Testing null hypothesis of no difference between groups|||||<|0.001||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 12 weeks||||<0.001
73934528|NCT03794089|147399067|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.008||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to Post-assessment (16 weeks)||||0.008
73972437|NCT05167864|147486199|SUPERIORITY|||||||0.88|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.880
73972438|NCT05167864|147486199|SUPERIORITY|||||||0.496|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement in the forehead post injection day 3|||0.496
73972439|NCT05167864|147486199|SUPERIORITY|||||||0.905|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.905
73972440|NCT05167864|147486199|SUPERIORITY|||||||0.692|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.692
73866008|NCT00434642|147278147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.1|||<|0.0001|TWO_SIDED|95.0|13.0|29.2||A P-value \< 0.05 was required for significance.|Cochran-Mantel-Haenszel|The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The difference in response rates and the 95% confidence intervals for response rates were computed using the normal approximation to the binomial distribution.|The null hypothesis was that there was no difference in the percentage of patients with an objective response between the 2 treatment groups. The alternative hypothesis was that a larger percentage of patients had an objective response in the carboplatin and gemcitabine + bevacizumab group.||29.2|13.0|<0.0001
73866009|NCT00434642|147278149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.6479|TWO_SIDED|95.0|0.771|1.176||Summaries of duration of overall survival (median, percentiles) were estimated from Kaplan-Meier curves. The 95% confidence interval for the median was computed using the method of Brookmeyer and Crowley.|Log Rank|The analysis was stratified for time since the last platinum therapy (≤12, \>12 months) and cytoreductive surgery for recurrent disease (Yes, No).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.|||1.176|0.771|0.6479
73972441|NCT05167864|147486199|SUPERIORITY|||||||0.262|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.262
73972442|NCT05167864|147486199|SUPERIORITY|||||||0.828|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.828
73866010|NCT00789672|147278184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_DEVIATION|4.7|||TWO_SIDED|95.0|-6.0|1.0||||||Given this was pilot study, no formal sample size estimates were calculated.||1|-6|
73934529|NCT03794089|147399068|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.44||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 4 weeks||||0.440
73934530|NCT03794089|147399068|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.022||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 8 weeks||||0.022
73934531|NCT03794089|147399068|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.032||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 12 weeks||||0.032
73934532|NCT03794089|147399068|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.091||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to Post-assessment (16 weeks)||||0.091
73934533|NCT03794089|147399069|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.058||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 4 weeks||||0.058
73934534|NCT03794089|147399069|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.032||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 8 weeks||||0.032
73934535|NCT03794089|147399069|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.007||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 12 weeks||||0.007
73934536|NCT03794089|147399069|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.044||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to Post assessment (16 weeks)||||0.044
73934537|NCT03794089|147399070|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.328||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 4 weeks||||0.328
73934538|NCT03794089|147399070|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.148||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 8 weeks||||0.148
73934539|NCT03794089|147399070|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.002||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 12 weeks||||0.002
73934540|NCT03794089|147399070|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.069||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to Post-assessment (16 weeks)||||0.069
73972443|NCT05167864|147486199|SUPERIORITY|||||||0.268|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.268
73934541|NCT03794089|147399071|SUPERIORITY|||||||0.928||||||a priori threshold for statistical significance was p\<=0.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline Q-LES-Q-SF total scores||||0.928
73934542|NCT03794089|147399072|SUPERIORITY|||||||0.402||||||a priori threshold for statistical significance was p\<.05|Fisher Exact|degrees of freedom = 1||Testing null hypothesis of no difference between groups||||0.402
73934543|NCT03794089|147399073|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|||Testing the null hypothesis of no difference between groups||||<0.001
73934544|NCT03794089|147399074|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|Used Satterthwaite method given unequal variances||Testing the null hypothesis of no difference between groups||||.006
73934545|NCT03794089|147399075|SUPERIORITY|||||||0.004||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|used Satterthwaite method given unequal variances||Testing the null hypothesis of no difference between groups||||0.004
73934546|NCT03794089|147399076|SUPERIORITY|||||||0.002||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|||Testing the null hypothesis of no difference between groups||||0.002
73972444|NCT05167864|147486199|SUPERIORITY|||||||0.975|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.975
74088833|NCT00484419|147730830|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0125
74088834|NCT00484419|147730833|SUPERIORITY_OR_OTHER|||||||0.8596||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.8596
74088835|NCT00484419|147730833|SUPERIORITY_OR_OTHER|||||||0.0257||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0257
74088836|NCT00484419|147730833|SUPERIORITY_OR_OTHER|||||||0.1862||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1862
74088837|NCT00484419|147730834|SUPERIORITY_OR_OTHER|||||||0.7094||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.7094
73866011|NCT04473664|147278190|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|95.1|||||TWO_SIDED|90.0|77.1|117.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||117|77.1|
73934547|NCT02034578|147399090|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.953|||||TWO_SIDED|90.0|0.873|1.04||||||B versus A||1.040|0.873|
73934548|NCT02034578|147399090|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.805|||||TWO_SIDED|90.0|0.749|0.865||||||C versus A||0.865|0.749|
73934549|NCT02034578|147399092|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.966|||||TWO_SIDED|90.0|0.924|1.01||||||B versus A||1.010|0.924|
73934550|NCT02034578|147399092|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.919|||||TWO_SIDED|90.0|0.896|0.942||||||C versus A||0.942|0.896|
73934551|NCT02034578|147399093|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.968|||||TWO_SIDED|90.0|0.926|1.011||||||B versus A||1.011|0.926|
73934552|NCT02034578|147399093|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.922|||||TWO_SIDED|90.0|0.899|0.947||||||C versus A||0.947|0.899|
73934553|NCT00116805|147399117|NON_INFERIORITY_OR_EQUIVALENCE|With a sample size of 160 subjects in the TDF group and 80 subjects in the ADV group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the TDF treatment was inferior to the ADV treatment (the difference in proportions was less than -0.080) in favor of the alternative hypothesis that the TDF treatment was not inferior.|Difference in proportions|54.1|STANDARD_ERROR_OF_MEAN|4.8|<|0.001|TWO_SIDED|95.0|44.6|63.6||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≤ 4 x upper limit of the normal range \[ULN\] or \> 4 x ULN) difference is 0.|Z-test|2-sided 95% confidence interval (CI), stratified by baseline ALT was used to evaluate difference between groups in proportion of complete responders.||||63.6|44.6|<0.001
73934554|NCT00116805|147399118|SUPERIORITY_OR_OTHER||Difference in proportions|63.1|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|53.8|72.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero.|Z-test|Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||||72.3|53.8|<0.001
74088838|NCT00484419|147730834|SUPERIORITY_OR_OTHER|||||||0.1394||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1394
73934555|NCT00116805|147399119|SUPERIORITY_OR_OTHER||Difference in proportions|-1.4|STANDARD_ERROR_OF_MEAN|5.4||0.801|TWO_SIDED|95.0|-12.0|9.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero.|Z-test|Two-sided 95% CIs, stratified by baseline ALT (baseline ALT ≤ 4 x ULN or \> 4 x ULN), were used to evaluate treatment group differences.||||9.3|-12.0|0.801
73934556|NCT00116805|147399124|SUPERIORITY_OR_OTHER||Difference in proportions|5.8|STANDARD_ERROR_OF_MEAN|5.8||0.32|TWO_SIDED|95.0|-5.6|17.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||||17.2|-5.6|0.320
73934557|NCT00116805|147399130|SUPERIORITY_OR_OTHER||Difference in proportions|13.6|STANDARD_ERROR_OF_MEAN|6.4||0.032|TWO_SIDED|95.0|1.1|26.1||P-value corresponds to a Z-test. Statistical tests were not adjusted for baseline ALT stratum.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).||||26.1|1.1|0.032
73972445|NCT05167864|147486199|SUPERIORITY|||||||0.499|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.499
73972446|NCT05167864|147486199|SUPERIORITY|||||||0.75|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.750
73972447|NCT05167864|147486199|SUPERIORITY|||||||0.433|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.433
73972448|NCT05167864|147486199|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.834
73972449|NCT05167864|147486199|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.834
73972450|NCT05167864|147486199|SUPERIORITY|||||||0.526|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.526
73972451|NCT05167864|147486199|SUPERIORITY|||||||0.816|TWO_SIDED|95.0|||||Wilcoxon singed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.816
73972452|NCT05167864|147486199|SUPERIORITY|||||||0.65|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.650
73972453|NCT05167864|147486199|SUPERIORITY|||||||0.095|TWO_SIDED|95.0|||||wilcoxon rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.095
73934558|NCT00116805|147399131|SUPERIORITY_OR_OTHER||Difference in proportions|-9.8|STANDARD_ERROR_OF_MEAN|6.0||0.1|TWO_SIDED|95.0|-21.5|1.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).||||1.9|-21.5|0.100
73934559|NCT00116805|147399136|SUPERIORITY_OR_OTHER||Difference in proportions|6.1|STANDARD_ERROR_OF_MEAN|5.3||0.245|TWO_SIDED|95.0|-4.2|16.4||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg loss.||16.4|-4.2|0.245
73972454|NCT05167864|147486199|SUPERIORITY|||||||0.618|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.618
73972455|NCT05167864|147486199|SUPERIORITY|||||||0.34|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.340
73972456|NCT05167864|147486199|SUPERIORITY|||||||0.15|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.150
73972457|NCT05167864|147486199|SUPERIORITY|||||||0.361|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.361
73972458|NCT05167864|147486199|SUPERIORITY|||||||0.428|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.428
73972459|NCT05167864|147486199|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.834
73972460|NCT05167864|147486199|SUPERIORITY|||||||0.318|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.318
73972461|NCT05167864|147486199|SUPERIORITY|||||||0.311|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.311
73866012|NCT04473664|147278192|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|109.0|||||TWO_SIDED|90.0|59.5|201.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for Quizartinib.||201|59.5|
73972462|NCT05167864|147486199|SUPERIORITY|||||||0.885|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.885
73972463|NCT05167864|147486199|SUPERIORITY|||||||0.457|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.457
73972464|NCT05167864|147486199|SUPERIORITY|||||||0.745|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.745
73972465|NCT05167864|147486199|SUPERIORITY|||||||0.757|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.757
73972466|NCT05167864|147486199|SUPERIORITY|||||||0.562|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.562
73972467|NCT05167864|147486199|SUPERIORITY|||||||0.828|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.828
73972468|NCT05167864|147486199|SUPERIORITY|||||||0.005|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.005
73972469|NCT05167864|147486199|SUPERIORITY|||||||0.437|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.437
73972470|NCT04089059|147486213|SUPERIORITY|Poisson regression for comparison of incidence rate against performance goal (0.43)|||||<|0.0001|||||||Poisson Regression|||||||<0.0001
73972471|NCT04089059|147486216|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Comparison of HF Hospitalization events 6 months before implant vs 6 months after implant||||<0.0001
73972472|NCT04089059|147486217|SUPERIORITY|Comparison of the incidence rate of HF hospitalizations or emergency department / hospital outpatient IV diuretic visits of Former Control Arm versus Modified Intent to Treat Arm at 6 months post-implant/Subgroup Analysis||||||0.0697|||||||Poisson Regression|||||||0.0697
73972473|NCT04089059|147486220|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.||||||0.0952|||||||Wilcoxon (Mann-Whitney)|||||||0.0952
73972474|NCT04089059|147486220|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.0090
73972475|NCT04089059|147486220|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73972476|NCT04089059|147486222|SUPERIORITY|Comparison of KCCQ at baseline and at 6 months||||||0.0026|||||||Wilcoxon (Mann-Whitney)|||||||0.0026
74088839|NCT00484419|147730834|SUPERIORITY_OR_OTHER|||||||0.4528||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.4528
73934560|NCT00116805|147399136|SUPERIORITY_OR_OTHER||Difference in proportions|4.7|STANDARD_ERROR_OF_MEAN|5.2||0.363|TWO_SIDED|95.0|-5.5|14.9||P-value for HBeAg seroconversion corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg seroconversion.||14.9|-5.5|0.363
73934561|NCT00116805|147399137|SUPERIORITY_OR_OTHER||Difference in proportions|0.3|STANDARD_ERROR_OF_MEAN|5.9||0.963|TWO_SIDED|95.0|-11.3|11.9||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg loss.||11.9|-11.3|0.963
73934562|NCT00116805|147399137|SUPERIORITY_OR_OTHER||Difference in proportions|0.7|STANDARD_ERROR_OF_MEAN|5.6||0.904|TWO_SIDED|95.0|-10.4|11.7||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \>4 x ULN).||This information pertains to seroconversion to anti-HBe.||11.7|-10.4|0.904
73934563|NCT00116805|147399138|SUPERIORITY_OR_OTHER||Difference in proportions|10.9|STANDARD_ERROR_OF_MEAN|4.6||0.018|TWO_SIDED|95.0|1.9|19.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg loss.||19.9|1.9|0.018
73934564|NCT00116805|147399138|SUPERIORITY_OR_OTHER||Difference in proportions|4.3|STANDARD_ERROR_OF_MEAN|3.0||0.148|TWO_SIDED|95.0|-1.5|10.2||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg seroconversion.||10.2|-1.5|0.148
73934565|NCT00116805|147399139|SUPERIORITY_OR_OTHER||Difference in proportions|0.9|STANDARD_ERROR_OF_MEAN|2.9||0.757|TWO_SIDED|95.0|-4.8|6.5||P-value above for HBsAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg loss.||6.5|-4.8|0.757
73934566|NCT00116805|147399139|SUPERIORITY_OR_OTHER||Difference in proportions|0.9|STANDARD_ERROR_OF_MEAN|2.6||0.733|TWO_SIDED|95.0|-4.2|5.9||P-value above corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to seroconversion to anti-HBs.||5.9|-4.2|0.733
73972477|NCT04089059|147486223|OTHER|Test of difference in distribution of NYHA class from baseline (all patients were class III at baseline).|||||<|0.0001|||||||Chi-squared|||The New York Heart Association (NYHA) Classification is a system used to evaluate and classify the severity of heart failure based on symptoms, patient's physical activity, and quality of life. Its scale ranges from class 1 to 4 with class 1 indicating the least severe heart failure symptoms (i.e., the best functionality) and class 4 indicating the most severe heart failure symptoms (i.e., the poorest functionality), with higher classes indicating poorer functioning as relates to heart failure.||||<0.0001
73866013|NCT04473664|147278192|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|109.0|||||TWO_SIDED|90.0|57.9|207.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for Quizartinib.||207|57.9|
73934567|NCT01782131|147399151|NON_INFERIORITY|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme. The p-Value is based on the one-sided non-inferiority test. Non-inferiority of posaconazole vs. voriconazole is established if the upper limit of the 95% confidence interval is less than 10%.|Estimated Difference in Percent|-5.3|||<|0.0001|TWO_SIDED|95.0|-11.6|1.0|||Miettinen and Nurminen|||||1.0|-11.6|<.0001
73934568|NCT01782131|147399152|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|0.3|||||TWO_SIDED|95.0|-8.2|8.8||||||||8.8|-8.2|
73934569|NCT01782131|147399153|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|-2.5|||||TWO_SIDED|95.0|-9.9|4.9||||||||4.9|-9.9|
73972478|NCT04089059|147486224|SUPERIORITY|Comparison of baseline 6MWT vs 6 month 6MWT.||||||0.1086|||||||Wilcoxon (Mann-Whitney)|||||||0.1086
73972479|NCT04089059|147486227|SUPERIORITY|Compare NTproBNP at baseline with 6 months||||||0.0628|||||||Wilcoxon (Mann-Whitney)|||||||0.0628
73934570|NCT01782131|147399154|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|3.1|||||TWO_SIDED|95.0|-6.9|13.1||||||||13.1|-6.9|
73934571|NCT01782131|147399155|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|-3.4|||||TWO_SIDED|95.0|-13.9|7.1||||||||7.1|-13.9|
73972480|NCT03314688|147486234|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||||||0.69
73972481|NCT03314688|147486235|SUPERIORITY|||||||0.33|||||||Chi-squared|||Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'||||0.33
73972482|NCT03314688|147486235|SUPERIORITY|||||||0.44|||||||Chi-squared|||Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.44
73972483|NCT03314688|147486235|SUPERIORITY|||||||0.29|||||||Chi-squared|||Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.29
73934572|NCT01782131|147399156|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Difference in Percent|-0.6|||||TWO_SIDED|95.0|-11.2|10.1||||||||10.1|-11.2|
73866014|NCT04473664|147278196|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|74.4|||||TWO_SIDED|90.0|32.0|173.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||173|32.0|
73934573|NCT01782131|147399157|OTHER||Survival Rate in Percent|60.7||||0.2767|TWO_SIDED|95.0|52.8|67.8||Based on Stratified Log-Rank method stratified by the risk for mortality/poor outcome (high risk, not high risk).|Kaplan-Meier|From product-limit (Kaplan-Meier) method for censored data.||Analysis of Time to All-Cause Mortality Through Day 114: Posaconazole vs. Voriconazole||67.8|52.8|0.2767
73934574|NCT01782131|147399158|OTHER|Based on Miettinen and Nurminen's method.|Difference in Percent|20.4|||||TWO_SIDED|95.0|-4.1|42.7||||||||42.7|-4.1|
73934575|NCT01782131|147399159|OTHER|Based on Miettinen and Nurminen's method.|Difference in Percent|11.3|||||TWO_SIDED|95.0|-6.9|28.6||||||||28.6|-6.9|
73934576|NCT01782131|147399160|OTHER||Difference in Percent|0.3||||0.8305|TWO_SIDED|95.0|-2.9|3.6|||Miettinen & Nurminen|||Abnormal Hepatic Laboratory Value||3.6|-2.9|0.8305
73934577|NCT01782131|147399160|OTHER||Difference in Percent|-3.6||||0.3633|TWO_SIDED|95.0|-11.3|4.2|||Miettinen & Nurminen|||CNS and Visual Disturbances||4.2|-11.3|0.3633
73934578|NCT01782131|147399160|OTHER||Difference in Percent|-2.8||||0.3724|TWO_SIDED|95.0|-9.1|3.4|||Miettinen & Nurminen|||Dermatologic Reactions||3.4|-9.1|0.3724
73934579|NCT01782131|147399160|OTHER||Difference in Percent|1.0||||0.6431|TWO_SIDED|95.0|-3.4|5.5|||Miettinen & Nurminen|||Adrenal Insufficiency or Temporal Hypotension||5.5|-3.4|0.6431
73934580|NCT01782131|147399161|OTHER|Based on Miettinen \& Nurminen|Difference in Percent|0.0|||||TWO_SIDED|95.0|-2.8|2.8||||||||2.8|-2.8|
73934581|NCT01782131|147399162|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-10.2|||||TWO_SIDED|95.0|-17.9|-2.4||||||||-2.4|-17.9|
73934582|NCT01782131|147399163|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|1.9|||||TWO_SIDED|95.0|-6.1|9.8||||||||9.8|-6.1|
73934583|NCT01782131|147399164|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-1.4|||||TWO_SIDED|95.0|-5.6|2.7||||||||2.7|-5.6|
73934584|NCT01782131|147399165|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-3.2|||||TWO_SIDED|95.0|-11.0|4.5||||||||4.5|-11.0|
73934585|NCT01138124|147399181|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.04|||<|0.0001|TWO_SIDED|95.0|1.51|2.75|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.75|1.51|<0.0001
73934586|NCT01138124|147399181|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.82||||0.0001|TWO_SIDED|95.0|1.34|2.46|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.46|1.34|0.0001
73934587|NCT01138124|147399181|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.52||||0.0627|TWO_SIDED|95.0|0.98|2.36|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||2.36|0.98|0.0627
73934588|NCT01138124|147399181|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.33||||0.2183|TWO_SIDED|95.0|0.85|2.08|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.08|0.85|0.2183
73934589|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.82|||<|0.0001|TWO_SIDED|95.0|1.86|4.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.28|1.86|<0.0001
73934590|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.53|||<|0.0001|TWO_SIDED|95.0|1.66|3.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy"|||3.85|1.66|<0.0001
73934591|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.75||||0.001|TWO_SIDED|95.0|1.51|5.03|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.03|1.51|0.001
73934592|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.44||||0.0042|TWO_SIDED|95.0|1.32|4.49|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.49|1.32|0.0042
73934593|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.8||||0.0645|TWO_SIDED|95.0|0.97|3.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.36|0.97|0.0645
73934594|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.65||||0.1232|TWO_SIDED|95.0|0.87|3.11|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||3.11|0.87|0.1232
73934595|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.55||||0.316|TWO_SIDED|95.0|0.17|1.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.78|0.17|0.3160
73934596|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.48||||0.2234|TWO_SIDED|95.0|0.15|1.57|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||1.57|0.15|0.2234
73934597|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.35||||0.3071|TWO_SIDED|95.0|0.76|2.42|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.42|0.76|0.3071
73934598|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.17||||0.6062|TWO_SIDED|95.0|0.65|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.11|0.65|0.6062
73934599|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.31||||0.5205|TWO_SIDED|95.0|0.58|2.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.97|0.58|0.5205
73934600|NCT01138124|147399182|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.11||||0.8042|TWO_SIDED|95.0|0.48|2.57|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.57|0.48|0.8042
73934601|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|3.15|||<|0.0001|TWO_SIDED|95.0|2.04|4.86|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.86|2.04|<0.0001
73866015|NCT04473664|147278198|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|62.5|||||TWO_SIDED|90.0|35.3|111.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for AC886.||111|35.3|
73866016|NCT04473664|147278198|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|69.9|||||TWO_SIDED|90.0|46.8|104.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for AC886.||104|46.8|
73866017|NCT04473664|147278201|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|44.7|||||TWO_SIDED|90.0|18.0|111.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||111|18.0|
73934602|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.88|||<|0.0001|TWO_SIDED|95.0|1.85|4.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.46|1.85|<0.0001
73934603|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.75||||0.0015|TWO_SIDED|95.0|1.47|5.13|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.13|1.47|0.0015
73934604|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.45||||0.0053|TWO_SIDED|95.0|1.31|4.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.62|1.31|0.0053
73972484|NCT03314688|147486236|SUPERIORITY|||||||0.69|||||||Chi-squared|||Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'||||0.69
74088840|NCT00484419|147730836|SUPERIORITY_OR_OTHER|||||||0.0374||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0374
73866018|NCT04473664|147278202|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|51.5|||||TWO_SIDED|90.0|16.0|165.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for Quizartinib.||165|16.0|
73866019|NCT04473664|147278202|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|51.5|||||TWO_SIDED|90.0|15.8|168.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for Quizartinib.||168|15.8|
73866020|NCT03392649|147278206|SUPERIORITY|||||||0.6|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
73866021|NCT03392649|147278207|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||0.34
73934605|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.68||||0.0777|TWO_SIDED|95.0|0.94|2.99|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.99|0.94|0.0777
73934606|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.5||||0.1762|TWO_SIDED|95.0|0.83|2.69|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.69|0.83|0.1762
73934607|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.82||||0.699|TWO_SIDED|95.0|0.29|2.28|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.28|0.29|0.6990
73934608|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.72||||0.5274|TWO_SIDED|95.0|0.26|2.01|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.01|0.26|0.5274
73934609|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.34||||0.3245|TWO_SIDED|95.0|0.75|2.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.39|0.75|0.3245
73972485|NCT03314688|147486236|SUPERIORITY|||||||0.91|||||||Chi-squared|||Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.91
74088841|NCT00484419|147730836|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
74088842|NCT00484419|147730836|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0001
73866022|NCT03392649|147278208|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
73866023|NCT03392649|147278209|SUPERIORITY|||||||0.09|||||||Fisher Exact|||||||0.09
73934610|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.6388|TWO_SIDED|95.0|0.64|2.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.07|0.64|0.6388
73934611|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.11||||0.796|TWO_SIDED|95.0|0.49|2.51|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.51|0.49|0.796
73934612|NCT01138124|147399183|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.94||||0.8772|TWO_SIDED|95.0|0.41|2.15|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.15|0.41|0.8772
73934613|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.9|||<|0.0001|TWO_SIDED|95.0|1.88|4.47|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.47|1.88|<0.0001
74088843|NCT00484419|147730837|SUPERIORITY_OR_OTHER|||||||0.2701||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.2701
73866024|NCT03392649|147278210|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.16
73934614|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.65|||<|0.0001|TWO_SIDED|95.0|1.71|4.11|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.11|1.71|<0.0001
73934615|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.19||||0.0212|TWO_SIDED|95.0|1.12|4.25|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||4.25|1.12|0.0212
73934616|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.95||||0.0522|TWO_SIDED|95.0|0.99|3.81|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||3.81|0.99|0.0522
73934617|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.87||||0.0337|TWO_SIDED|95.0|1.05|3.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.32|1.05|0.0337
73934618|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.64||||0.0947|TWO_SIDED|95.0|0.92|2.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.95|0.92|0.0947
73934619|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.42||||0.3928|TWO_SIDED|95.0|0.64|3.16|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.16|0.64|0.3928
73934620|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.21||||0.6502|TWO_SIDED|95.0|0.54|2.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.72|0.54|0.6502
73934621|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.34||||0.3275|TWO_SIDED|95.0|0.75|2.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.39|0.75|0.3275
73934622|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.6365|TWO_SIDED|95.0|0.64|2.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.08|0.64|0.6365
73934623|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.01||||0.9858|TWO_SIDED|95.0|0.42|2.41|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.41|0.42|0.9858
73934624|NCT01138124|147399184|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.87||||0.7671|TWO_SIDED|95.0|0.36|2.12|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.12|0.36|0.7671
73934625|NCT01138124|147399185|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.79||||0.0031|TWO_SIDED|95.0|1.22|2.63|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.63|1.22|0.0031
73934626|NCT01138124|147399185|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.68||||0.0095|TWO_SIDED|95.0|1.13|2.49|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.49|1.13|0.0095
73934627|NCT01138124|147399185|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.65||||0.097|TWO_SIDED|95.0|0.91|2.99|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||2.99|0.91|0.0970
73934628|NCT01138124|147399185|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.63||||0.1123|TWO_SIDED|95.0|0.89|2.97|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.97|0.89|0.1123
73934629|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.53||||0.0012|TWO_SIDED|95.0|1.44|4.44|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)"|||4.44|1.44|0.0012
74088844|NCT00484419|147730837|SUPERIORITY_OR_OTHER|||||||0.6117||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.6117
73866025|NCT03392649|147278211|SUPERIORITY|||||||0.67|||||||Fisher Exact|||||||0.67
73866026|NCT03392649|147278212|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
73866027|NCT03392649|147278213|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
73866028|NCT03927144|147278240|SUPERIORITY||Odds Ratio (OR)|6.48|||<|0.0001|TWO_SIDED|95.0|4.28|9.82|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (no. of prior prophylactic migraine treatment failures=1 vs 2) after missing data were imputed as non-response.||||9.82|4.28|<0.0001
73866029|NCT03927144|147278241|SUPERIORITY||Odds Ratio (OR)|11.27|||<|0.0001|TWO_SIDED|95.0|7.53|16.87|||Cochran-Mantel-Haenszel|Adjusted for number of prior prophylactic migraine treatment failures=1 vs 2 after missing data were imputed as non-response.||||16.87|7.53|<0.0001
73934630|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.34||||0.0034|TWO_SIDED|95.0|1.32|4.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.14|1.32|0.0034
73934631|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.18||||0.0856|TWO_SIDED|95.0|0.9|5.32|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.32|0.9|0.0856
73934632|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.14||||0.0996|TWO_SIDED|95.0|0.87|5.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.28|0.87|0.0996
73934633|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.89||||0.0563|TWO_SIDED|95.0|0.98|3.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.63|0.98|0.0563
73934634|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.77||||0.0896|TWO_SIDED|95.0|0.92|3.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.43|0.92|0.0896
73934635|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.4||||0.5308|TWO_SIDED|95.0|0.49|4.01|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.01|0.49|0.5308
73934636|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.39||||0.5458|TWO_SIDED|95.0|0.48|4.02|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.02|0.48|0.5458
73934637|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.87||||0.7744|TWO_SIDED|95.0|0.35|2.19|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.19|0.35|0.7744
73934638|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.83||||0.6999|TWO_SIDED|95.0|0.33|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.11|0.33|0.6999
73934639|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.32||||0.6528|TWO_SIDED|95.0|0.39|4.47|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.47|0.39|0.6528
73934640|NCT01138124|147399186|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.3||||0.6722|TWO_SIDED|95.0|0.38|4.47|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.47|0.38|0.6722
73934641|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|3.24|||<|0.0001|TWO_SIDED|95.0|1.79|5.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||5.85|1.79|<0.0001
73934642|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.9||||0.0005|TWO_SIDED|95.0|1.59|5.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.28|1.59|0.0005
73972486|NCT03314688|147486236|SUPERIORITY|||||||0.13|||||||Chi-squared|||Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.13
73972487|NCT05586490|147486300|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-0.6375||||0.429|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|Paired samples t-test, df = 7||||||0.429
74030446|NCT02078713|147615162|SUPERIORITY||Odds Ratio (OR)|0.97||||0.84|TWO_SIDED|95.0|0.76|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pull-out method. Patients were excluded from this analysis if they reported not having heard of the pull-out method in the post-visit survey.||1.25|0.76|0.84
73934643|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.54||||0.042|TWO_SIDED|95.0|1.03|6.25|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.25|1.03|0.042
73934644|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.4||||0.0603|TWO_SIDED|95.0|0.96|5.98|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.98|0.96|0.0603
73934645|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.35||||0.3762|TWO_SIDED|95.0|0.69|2.65|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.65|0.69|0.3762
73972488|NCT05586490|147486301|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|3.75||||0.351|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.351
73972489|NCT05586490|147486302|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-0.013||||0.937|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.937
73972490|NCT05586490|147486303|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-14.8||||0.044|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.044
73934646|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.33||||0.4073|TWO_SIDED|95.0|0.68|2.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.63|0.68|0.4073
73972491|NCT05586490|147486304|SUPERIORITY||Mean Difference (Net)|-0.68||||0.42|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.42
73866030|NCT03927144|147278242|SUPERIORITY||Treatment difference|-2.13|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.74|-1.52|||Linear mixed effects model||AMG334 70 mg/140 mg vs Oral Prophylactic|Comparison of mean change from baseline in monthly migraine days at Week 52||-1.52|-2.74|<0.001
73934647|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.95||||0.9294|TWO_SIDED|95.0|0.29|3.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.12|0.29|0.9294
73934648|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.99||||0.9875|TWO_SIDED|95.0|0.3|3.29|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.29|0.3|0.9875
73934649|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.19||||0.66|TWO_SIDED|95.0|0.54|2.63|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.63|0.54|0.66
73934650|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||0.811|TWO_SIDED|95.0|0.5|2.45|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.45|0.5|0.8110
73934651|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.7||||0.3336|TWO_SIDED|95.0|0.58|4.96|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.96|0.58|0.3336
73934652|NCT01138124|147399187|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.63||||0.3782|TWO_SIDED|95.0|0.55|4.84|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.84|0.55|0.3782
73934653|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.89||||0.0841|TWO_SIDED|95.0|0.92|3.88|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.88|0.92|0.0841
73934654|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.75||||0.1313|TWO_SIDED|95.0|0.85|3.63|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.63|0.85|0.1313
73934655|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.03||||0.1488|TWO_SIDED|95.0|0.78|5.34|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.34|0.78|0.1488
73934656|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.05||||0.1495|TWO_SIDED|95.0|0.77|5.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.46|0.77|0.1495
74030447|NCT02078713|147615162|SUPERIORITY||Odds Ratio (OR)|0.81||||0.07|TWO_SIDED|95.0|0.64|1.02||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the ring. Patients were excluded from this analysis if they reported not having heard of the ring in the post-visit survey.||1.02|0.64|0.07
73866031|NCT03927144|147278243|SUPERIORITY||Odds Ratio (OR)|13.75|||<|0.001|TWO_SIDED|95.0|9.08|20.83|||Cochran-Mantel-Haenszel|Adjusted for number of prior prophylactic migraine treatment failures=1 vs 2 after missing data were imputed as non-response.||||20.83|9.08|<0.001
73866032|NCT01463072|147278252|OTHER||Percent|35.0|||||TWO_SIDED|95.0|21.0|52.0|||||35% of participants were responders (CR+PR).|||52|21|
73934657|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.44||||0.0013|TWO_SIDED|95.0|1.42|4.22|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||4.22|1.42|0.0013
73934658|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.34||||0.0026|TWO_SIDED|95.0|1.35|4.07|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.07|1.35|0.0026
73934659|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.78||||0.2421|TWO_SIDED|95.0|0.68|4.69|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.69|0.68|0.2421
73934660|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.7||||0.2899|TWO_SIDED|95.0|0.64|4.53|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.53|0.64|0.2899
73934661|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.99||||0.9723|TWO_SIDED|95.0|0.42|2.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.29|0.42|0.9723
73934662|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.91||||0.8206|TWO_SIDED|95.0|0.39|2.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.13|0.39|0.8206
73934663|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.15||||0.8135|TWO_SIDED|95.0|0.35|3.82|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.82|0.35|0.8135
73934664|NCT01138124|147399188|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.8173|TWO_SIDED|95.0|0.34|3.86|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.86|0.34|0.8173
73934665|NCT00262834|147399196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.||||||0.42
73972492|NCT05586490|147486304|SUPERIORITY||Mean Difference (Net)|0.57||||0.5|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device group and no device group) controlling for pre-trial measurements, gender, and age.||||||0.50
73972493|NCT05586490|147486305|SUPERIORITY||Mean Difference (Net)|-0.03||||0.986|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.986
73934666|NCT00262834|147399197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.||||||0.50
73934667|NCT00262834|147399198|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
73934668|NCT01075074|147399209|SUPERIORITY_OR_OTHER|||||||0.006||||||Corrected for 6 comparisons.|Kruskal-Wallis|||A sample size of 23 subjects per group was estimated to achieve 80% power to detect a 10 point difference in the aggregated QOR40 score for the 3 study groups to be compared assuming an overall standard deviation of 12.||||0.006
73934669|NCT01075074|147399209|SUPERIORITY_OR_OTHER||Median Difference (Net)|16.0||||0.03|TWO_SIDED|95.0|1.0|30.0|||Wilcoxon (Mann-Whitney)|||||30|1|0.03
73934670|NCT01075074|147399209|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0||||0.01|TWO_SIDED|95.0|2.0|31.0|||Wilcoxon (Mann-Whitney)|||||31|2|0.01
73934671|NCT01075074|147399209|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||1|TWO_SIDED|95.0|-16.0|12.0|||Wilcoxon (Mann-Whitney)|||||12|-16|1.0
73972494|NCT05586490|147486305|SUPERIORITY||Mean Difference (Net)|-1.25||||0.479|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.479
73972495|NCT05586490|147486306|SUPERIORITY||Mean Difference (Net)|-0.195||||0.098|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.098
73972496|NCT05586490|147486306|SUPERIORITY||Mean Difference (Net)|-0.039||||0.729|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.729
73972497|NCT05586490|147486307|SUPERIORITY||Mean Difference (Net)|-8.15||||0.058|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.0580
73934672|NCT01075074|147399210|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||P values is corrected for 6 comparisons|Kruskal-Wallis|||||||0.0003
73934673|NCT01075074|147399210|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Corrected for 6 comparisons|Kruskal-Wallis|||||||0.0003
73934674|NCT01075074|147399210|SUPERIORITY_OR_OTHER||Median Difference (Net)|195.0||||0.0004|TWO_SIDED|95.0|98.0|300.0|||Wilcoxon (Mann-Whitney)|||||300|98|0.0004
73934675|NCT01075074|147399210|SUPERIORITY_OR_OTHER||Median Difference (Net)|195.0||||0.0003|TWO_SIDED|95.0|98.0|278.0|||Wilcoxon (Mann-Whitney)|||||278|98|0.0003
73934676|NCT01075074|147399210|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.86|TWO_SIDED|95.0|-105.0|83.0|||Wilcoxon (Mann-Whitney)|||||83|-105|0.86
73934677|NCT01075074|147399211|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis|||||||0.0005
73972498|NCT05586490|147486307|SUPERIORITY||Mean Difference (Net)|-1.54||||0.718|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.718
73972499|NCT05586490|147486309|SUPERIORITY||Mean Difference (Net)|0.063||||0.816|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.816
73972500|NCT05586490|147486309|SUPERIORITY||Mean Difference (Net)|-0.0048||||0.985|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.985
73972501|NCT05586490|147486310|SUPERIORITY||Mean Difference (Net)|6.33||||0.59|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.59
73972502|NCT05586490|147486310|SUPERIORITY||Mean Difference (Net)|8.16||||0.51|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.51
73972503|NCT04070573|147486320|SUPERIORITY||Risk Difference (RD)|0.035||||0.28|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.28
73934678|NCT01075074|147399211|SUPERIORITY_OR_OTHER||Median Difference (Net)|38.0||||0.01|TWO_SIDED|95.0|8.0|50.0|||Wilcoxon (Mann-Whitney)|||||50|8|0.01
73934679|NCT01075074|147399211|SUPERIORITY_OR_OTHER||Median Difference (Net)|40.0||||0.003|TWO_SIDED|95.0|12.0|47.0|||Wilcoxon (Mann-Whitney)|||||47|12|0.003
73934680|NCT01075074|147399211|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||0.95|TWO_SIDED|95.0|-18.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|-18|0.95
73934681|NCT01075074|147399212|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis|||||||0.03
73934682|NCT01075074|147399212|SUPERIORITY_OR_OTHER||Median Difference (Net)|30.0||||0.01|TWO_SIDED|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)|||||60|0|0.01
73934683|NCT01075074|147399212|SUPERIORITY_OR_OTHER||Median Difference (Net)|30.0||||0.04|TWO_SIDED|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)|||||60|0|0.04
73934684|NCT01075074|147399212|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.92|TWO_SIDED|95.0|-30.0|30.0|||Wilcoxon (Mann-Whitney)|||||30|-30|0.92
73934685|NCT04265755|147399213|OTHER|Adjusted analysis utilizes a logistic regression model which includes age, sex, dose switch, Baseline value of interest, and mPRS as covariates and presents the mPRS estimates.|Odds Ratio (OR)|1.01||||0.86|TWO_SIDED|95.0|0.9|1.13|||Regression, Logistic||Based on a 1 standard deviation increase in mPRS.|Odds of achieving at least 50% reduction from Baseline in mean MMD over months 4, 5, and 6 in relation to mPRS.||1.13|0.90|0.86
73934686|NCT00406029|147399252|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.753|TWO_SIDED|95.0|-0.9|1.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.753
73972504|NCT04070573|147486321|SUPERIORITY||Risk Difference (RD)|0.035||||0.31|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.31
73972505|NCT04070573|147486322|SUPERIORITY||Risk Difference (RD)|0.019||||0.61|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.61
73972506|NCT04070573|147486325|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.72|TWO_SIDED||||||t-test, 2 sided|||||||0.72
73934687|NCT00406029|147399252|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.162|TWO_SIDED|95.0|-1.7|0.3||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline at endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.7|0.162
73934688|NCT00406029|147399252|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.049|TWO_SIDED|95.0|-2.1|0.0||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-2.1|0.049
73934689|NCT00406029|147399252|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.019|TWO_SIDED|95.0|-2.2|-0.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-2.2|0.019
73934690|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.935|TWO_SIDED|95.0|-0.9|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.9|0.935
73934691|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.326|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.3|0.326
73934692|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.07|TWO_SIDED|95.0|-1.7|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.7|0.070
73934693|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.02|TWO_SIDED|95.0|-1.9|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-1.9|0.020
73934694|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.982|TWO_SIDED|95.0|-1.0|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.0|0.982
73934695|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.281|TWO_SIDED|95.0|-1.5|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.5|0.281
73934696|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.261|TWO_SIDED|95.0|-1.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.6|0.261
73934697|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.447|TWO_SIDED|95.0|-1.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.4|0.447
73934698|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.378|TWO_SIDED|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.6|0.378
74088845|NCT00484419|147730837|SUPERIORITY_OR_OTHER|||||||0.2007||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.2007
73934699|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.299|TWO_SIDED|95.0|-1.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.7|0.299
73934700|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.377|TWO_SIDED|95.0|-1.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.6|0.377
73934701|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.707|TWO_SIDED|95.0|-1.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-1.3|0.707
73934702|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.562|TWO_SIDED|95.0|-1.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.4|0.562
73934703|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.156|TWO_SIDED|95.0|-1.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.7|0.156
73934704|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.292|TWO_SIDED|95.0|-1.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.6|0.292
73934705|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.034|TWO_SIDED|95.0|-2.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-2.2|0.034
73934706|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.762|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.762
73934707|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.092|TWO_SIDED|95.0|-1.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.9|0.092
73934708|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.013|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-2.3|0.013
73934709|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.005|TWO_SIDED|95.0|-2.5|-0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.4|-2.5|0.005
73972507|NCT05062330|147486340|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.67|4.13|||Generalized estimating equation|||||4.13|1.67|<0.0001
74088846|NCT00484419|147730839|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
73866033|NCT01463072|147278254|SUPERIORITY||Odds Ratio (OR)|5.8||||0.01|TWO_SIDED|95.0|1.3|33.1|||Fisher Exact||Ratio is intermediate/high toxicity risk over low toxicity risk|CARG chemotherapy toxicity risk predictive of chemotherapy toxicity (grade 3)||33.1|1.3|0.01
73934710|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.293|TWO_SIDED|95.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.8|0.293
73934711|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.095|TWO_SIDED|95.0|-2.0|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-2.0|0.095
73934712|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.04||95.0|-2.3|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-2.3|0.040
73934713|NCT00406029|147399253|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.011|TWO_SIDED|95.0|-2.5|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-2.5|0.011
73934714|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.47|TWO_SIDED|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.6|0.470
73934715|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.505|TWO_SIDED|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.6|0.505
73934716|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.114|TWO_SIDED|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.2|0.114
73934717|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.042|TWO_SIDED|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|0.0|0.042
73972508|NCT03421340|147486450|NON_INFERIORITY|Non-Inferiority Margin of 10%|Risk Difference (RD)|1.8||||0.029|TWO_SIDED||||||exact|||||||0.029
74088847|NCT00484419|147730839|SUPERIORITY_OR_OTHER|||||||0.1864||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1864
73866034|NCT01463072|147278254|SUPERIORITY||Ratio of group means|1.38||||0.02|TWO_SIDED|95.0|1.04|1.8|||t-test, 2 sided||Ratio is dose reduction over no dose reduction.|CARG chemotherapy toxicity risk predictive of dose reduction due to chemotherapy toxicity||1.80|1.04|0.02
73866035|NCT01452919|147278275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.73|STANDARD_ERROR_OF_MEAN|1.25||0.17||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.170
73934718|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.684|TWO_SIDED|94.0|-0.8|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.8|0.684
73934719|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.489|TWO_SIDED|95.0|-0.7|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.7|0.489
73934720|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.305|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.5|0.305
73934721|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.451|TWO_SIDED|95.0|-0.6|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.6|0.451
73934722|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.68|TWO_SIDED|95.0|-1.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.5|0.680
73972509|NCT03421340|147486451|SUPERIORITY|Not powered|Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-8.0|4.1||||||||4.1|-8|
73972510|NCT03421340|147486452|SUPERIORITY||Median Difference (Net)|133.0|||||TWO_SIDED|95.0|120.0|143.0||||||||143|120|
73866036|NCT01452919|147278276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.8|STANDARD_ERROR_OF_MEAN|0.5||0.109||95.0||||Two-sided p-value. P-value is for Week 0.5.|Type 3 sums of squares|||||||0.109
73866037|NCT01452919|147278276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.4|STANDARD_ERROR_OF_MEAN|0.4||0.372||95.0||||Two-sided p-value. P-value is for Week 1.|Type 3 sums of squares|||||||0.372
73866038|NCT01452919|147278276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.555||95.0||||Two-sided p-value. P-value is for Week 1.5.|Type 3 sums of squares|||||||0.555
73934723|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.466|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.466
73934724|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.45|TWO_SIDED|95.0|-0.8|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.8|0.450
73972511|NCT03421340|147486453|SUPERIORITY||Median Difference (Final Values)|-10.2|||||TWO_SIDED|95.0|-11.6|-7.5||||||||-7.5|-11.6|
73972512|NCT02575950|147486489|SUPERIORITY||Mean Difference (Final Values)|-9.34|||<|0.001|TWO_SIDED|95.0|-14.71|-3.96|||ANCOVA|||Least square mean values and difference is from ANCOVA model with treatment as fixed effect and baseline total lesion count as covariate and participants as random effect. 100 simulations of monotone multiple imputation is performed. Summary statistics are found across these 100 simulations.||-3.96|-14.71|<.001
73972513|NCT04271046|147486501|OTHER|||||||0.97|||||||Regression, Linear|||||||0.97
73866039|NCT01452919|147278276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.806||95.0||||Two-sided p-value. P-value is for Week 2.|Type 3 sums of squares|||||||0.806
73972514|NCT04271046|147486502|OTHER|||||||0.55|||||||Regression, Linear|||||||0.55
74088848|NCT00484419|147730839|SUPERIORITY_OR_OTHER|||||||0.0999||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0999
73972515|NCT04271046|147486503|OTHER|||||||0.26|||||||Regression, Linear|||||||0.26
73934725|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.523|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.523
73934726|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.309|TWO_SIDED|95.0|-0.6|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.6|0.309
73972516|NCT04271046|147486504|OTHER|||||||0.42|||||||Regression, Linear|||||||0.42
73972517|NCT04271046|147486511|OTHER|||||||0.08|||||||Regression, Linear|||||||0.08
73972518|NCT04271046|147486512|OTHER|||||||0.79|||||||Regression, Linear|||||||0.79
73972519|NCT04271046|147486513|OTHER|||||||0.6|||||||Regression, Linear|||||||0.60
73934727|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.136|TWO_SIDED|95.0|-0.3|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.3|0.136
73934728|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.106|TWO_SIDED|95.0|-0.2|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.2|0.106
73934729|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.144|TWO_SIDED|95.0|-0.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.3|0.144
73934730|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.954|TWO_SIDED|95.0|-1.1|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.1|0.954
73934731|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.152|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.3|0.152
73934732|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.012|TWO_SIDED|95.0|0.3|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.3|0.012
73934733|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.025|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.025
73972520|NCT04271046|147486514|OTHER|||||||0.86|||||||Regression, Linear|||||||0.86
73972521|NCT04271046|147486515|OTHER|||||||0.46|||||||Regression, Linear|||||||0.46
73972522|NCT04271046|147486516|OTHER|||||||0.55|||||||Regression, Linear|||||||0.55
73972523|NCT04271046|147486517|OTHER|||||||0.63|||||||Regression, Linear|||||||0.63
73972524|NCT04271046|147486518|OTHER|||||||0.28|||||||Regression, Linear|||||||0.28
73934734|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.151|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.3|0.151
73934735|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.235|TWO_SIDED|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.5|0.235
73972525|NCT04271046|147486519|OTHER|||||||0.82|||||||Regression, Linear|||||||0.82
73972526|NCT04271046|147486520|OTHER|||||||0.04|||||||Regression, Linear|||||||0.04
73972527|NCT04271046|147486521|OTHER|||||||0.98|||||||Regression, Linear|||||||0.98
73972528|NCT04271046|147486522|OTHER|||||||0.22|||||||Regression, Linear|||||||0.22
73972529|NCT04271046|147486523|OTHER|||||||0.85|||||||Regression, Linear|||||||0.85
73972530|NCT04271046|147486524|OTHER|||||||0.8|||||||Regression, Linear|||||||0.80
73972531|NCT04707469|147486530|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.|Treatment difference|-0.27||||0.0006|TWO_SIDED|95.0|-0.42|-0.12||Unadjusted two-sided p-value for test of no difference.|ANCOVA|||Treatment policy estimand||-0.12|-0.42|0.0006
73972532|NCT04707469|147486530|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.|Treatment difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.38||Unadjusted two-sided p-value for test of no difference.|ANCOVA|||Treatment policy estimand||-0.38|-0.68|<.0001
73972533|NCT04487860|147486569|SUPERIORITY|||||||0.7905|||||||ANCOVA|||||||0.7905
73972534|NCT04487860|147486569|SUPERIORITY|||||||0.7372|||||||ANCOVA|||||||0.7372
73972535|NCT04487860|147486569|SUPERIORITY|||||||0.2989|||||||ANCOVA|||||||0.2989
73972536|NCT04487860|147486569|SUPERIORITY|||||||0.3328|||||||ANCOVA|||||||0.3328
73972537|NCT04487860|147486570|SUPERIORITY|||||||0.8989|||||||ANCOVA|||||||0.8989
73972538|NCT04487860|147486570|SUPERIORITY|||||||0.6768|||||||ANCOVA|||||||0.6768
73972539|NCT04487860|147486570|SUPERIORITY|||||||0.8209|||||||ANCOVA|||||||0.8209
73972540|NCT04487860|147486570|SUPERIORITY|||||||0.3106|||||||ANCOVA|||||||0.3106
73972541|NCT04487860|147486571|SUPERIORITY|||||||0.8593|||||||ANCOVA|||||||0.8593
73972542|NCT04487860|147486571|SUPERIORITY|||||||0.9594|||||||ANCOVA|||||||0.9594
73972543|NCT04487860|147486571|SUPERIORITY|||||||0.9041|||||||ANCOVA|||||||0.9041
73972544|NCT04487860|147486571|SUPERIORITY|||||||0.7147|||||||ANCOVA|||||||0.7147
73972545|NCT05218096|147486574|OTHER|Difference|Difference|-7.1||||0.6797|TWO_SIDED|90.0|-28.8|15.0|||Barnard's Unconditional Exact Test||CI calculated using the Chan and Zhang method.|||15.0|-28.8|0.6797
73972546|NCT05218096|147486574|OTHER|Difference|Difference|-7.1||||0.7341|TWO_SIDED|90.0|-34.8|19.3|||Barnard's Unconditional Exact Test||CI calculated using the Chan and Zhang method.|||19.3|-34.8|0.7341
73934736|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.007|TWO_SIDED|95.0|0.5|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|0.5|0.007
73934737|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.033|TWO_SIDED|95.0|0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.1|0.033
73934738|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.757|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.757
73934739|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.341|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.5|0.341
73934740|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.024|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.024
73934741|NCT00406029|147399254|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.049|TWO_SIDED|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|0.0|0.049
73934742|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.151|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.3|0.151
73934743|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.93|TWO_SIDED|95.0|-1.1|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.1|0.930
73934744|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.343|TWO_SIDED|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.6|0.343
73934745|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.746|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.746
73934746|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.222|TWO_SIDED|94.0|-0.5|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.5|0.222
73934747|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.673|TWO_SIDED|95.0|-1.0|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.0|0.673
73934748|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.415|TWO_SIDED|95.0|-0.7|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.7|0.415
73934749|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.968|TWO_SIDED|95.0|-1.3|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.3|0.968
73934750|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.543|TWO_SIDED|95.0|-1.0|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.0|0.543
73934751|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.967|TWO_SIDED|95.0|-1.4|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.4|0.967
73972547|NCT03442309|147486635|NON_INFERIORITY|NI margin for arrest difference of 10%|Mean Difference (Final Values)|-0.11|||||TWO_SIDED|95.0|-0.22|0.01||||||||0.01|-.22|
73934752|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.411|TWO_SIDED|95.0|-0.8|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.8|0.411
73934753|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.864|TWO_SIDED|95.0|-1.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.6|0.864
73934754|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.449|TWO_SIDED|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.9|0.449
73866040|NCT01452919|147278277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.762||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.762
73934755|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.411|TWO_SIDED|95.0|-2.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-2.0|0.411
73972548|NCT03442309|147486636|NON_INFERIORITY|Non-inferiority OR (OR δ, 0.63)|Odds Ratio (OR)|0.94|||||TWO_SIDED|90.0|0.82|1.08||||||||1.08|0.82|
73972549|NCT05207982|147486651|OTHER|||||||||||||||||This study utilized a multiple baseline single case experimental design in which analysis of the daily weights (for each participant) involved discontinuous growth curve analysis using multi-level modeling. Separate models were developed for each participant which include the daily weights from the baseline, treatment and follow-up phases. Given the nature of the data, we hypothesized different slopes for the baseline vs treatment phases. Overall weight change was a primary outcome measure.|Multiple baseline single case experimental design in which analysis of the daily weights (for each participant) involved discontinuous growth curve analysis using multi-level modeling.|||
73972550|NCT03728608|147486668|SUPERIORITY|||||||0.92|||||||survival analysis|||||||0.92
73972551|NCT03728608|147486669|SUPERIORITY|||||||0.65|||||||survival analysis|||||||0.65
73934756|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.576|TWO_SIDED|95.0|-1.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.0|0.576
73934757|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.603|TWO_SIDED|95.0|-1.9|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.9|0.603
73972552|NCT03728608|147486670|SUPERIORITY|||||||0.96|||||||survival analysis|||||||0.96
73934758|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.842|TWO_SIDED|95.0|-1.4|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.4|0.842
73934759|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.558|TWO_SIDED|95.0|-1.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.9|0.558
73934760|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.245|TWO_SIDED|95.0|-0.6|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|-0.6|0.245
73934761|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.93|TWO_SIDED|95.0|-1.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.5|0.930
73934762|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.759|TWO_SIDED|95.0|-1.5|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.5|0.759
73934763|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.374|TWO_SIDED|95.0|-2.4|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-2.4|0.374
73934764|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.621|TWO_SIDED|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.3|0.621
73934765|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.607|TWO_SIDED|95.0|-2.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-2.1|0.607
73934766|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.907|TWO_SIDED|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.4|0.907
73934767|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.368|TWO_SIDED|95.0|-2.1|0.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-2.1|0.368
73934768|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.654|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.1|0.654
73934769|NCT00406029|147399255|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.769|TWO_SIDED|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.7|0.769
73934770|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.055|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.0|0.055
73972553|NCT03728608|147486671|SUPERIORITY|||||||0.77|||||||survival analysis|||||||0.77
73972554|NCT03728608|147486672|SUPERIORITY|||||||0.43|||||||Regression, Logistic|||||||0.43
73934771|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.071|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.0|0.071
73934772|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.288|TWO_SIDED|95.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.8|0.288
73934773|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.764|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.6|0.764
73934774|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.342|TWO_SIDED|94.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.9|0.342
73972555|NCT03728608|147486673|SUPERIORITY|||||||0.97|||||||Regression, Logistic|||||||0.97
73972556|NCT03728608|147486674|SUPERIORITY|||||||0.97|||||||Regression, Logistic|||||||0.97
73972557|NCT03728608|147486675|SUPERIORITY|||||||0.79|||||||Regression, Logistic|||||||0.79
73972558|NCT01828112|147486716|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.36|0.67|||Log Rank|||||0.67|0.36|<0.001
73972559|NCT00429364|147486768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.08
73866041|NCT01452919|147278278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.506||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.506
73866042|NCT01452919|147278279|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.515||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.515
73866043|NCT01452919|147278282|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.966||95.0||||One-sided p-value.|Type 3 sums of squares|||||||0.966
73866044|NCT01452919|147278283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.92|STANDARD_ERROR_OF_MEAN|0.73||0.895||95.0||||One-sided p-value.|Type 3 sums of squares|||||||0.895
73866045|NCT01192412|147278284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.77|1.35||||||We estimated that with a sample size of 514 per group, the study would have 80% power, at a two-tailed alpha level of 0.05, assuming primary outcome rates of 33% in the tight-control group and 25% in the less-tight-control group, a 10% rate of crossover, a 1% loss to follow-up, and two interim analyses, as calculated with the chi-square test with the use of East software (Cytel) and the Lan-DeMets spending function with O'Brien-Fleming-type boundaries for early stopping.||1.35|0.77|
74039407|NCT04847141|147632411|SUPERIORITY||Difference in Percentage|2.6||||0.1441|TWO_SIDED|95.0|-1.2|7.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required oxygen supplementation between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between each of 2 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.|||7.3|-1.2|0.1441
73866046|NCT01192412|147278285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||||TWO_SIDED|95.0|0.79|3.84||||||||3.84|0.79|
73866047|NCT03194646|147278331|OTHER||Mean Difference (Final Values)|-1.85|||||TWO_SIDED|95.0|-2.44|-1.26||||||||-1.26|-2.44|
73866048|NCT03194646|147278331|OTHER||Mean Difference (Final Values)|-2.34|||||TWO_SIDED|95.0|-2.87|-1.8||||||||-1.80|-2.87|
73866049|NCT03194646|147278331|OTHER||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-2.51|-1.1||||||||-1.10|-2.51|
73866050|NCT01178099|147278344|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.05|||||TWO_SIDED|90.0|0.829|1.33|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall).|||1.33|0.829|
73866051|NCT01178099|147278344|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.895|||||TWO_SIDED|90.0|0.718|1.12|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD.|||1.12|0.718|
73866052|NCT01178099|147278344|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.905|||||TWO_SIDED|90.0|0.656|1.25|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 5 mg MD.|||1.25|0.656|
73866053|NCT01178099|147278345|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.953|||||TWO_SIDED|90.0|0.664|1.37|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall).|||1.37|0.664|
73866054|NCT01178099|147278345|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.612|||||TWO_SIDED|90.0|0.436|0.86|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD.|||0.860|0.436|
73866055|NCT01178099|147278345|SUPERIORITY_OR_OTHER||Geometric LS Means, SCD:Healthy|1.03|||||TWO_SIDED|90.0|0.625|1.68|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD.|||1.68|0.625|
73866056|NCT01178099|147278346|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.070
73866057|NCT01178099|147278347|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.52|||||TWO_SIDED|90.0|1.1|2.1|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.|||2.10|1.10|
73866058|NCT01178099|147278347|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.44|||||TWO_SIDED|90.0|1.06|1.94|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-95913 metabolite.|||1.94|1.06|
73866059|NCT01178099|147278347|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.43|||||TWO_SIDED|90.0|0.918|2.21|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-95913 metabolite.|||2.21|0.918|
73866060|NCT01178099|147278347|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.971|||||TWO_SIDED|90.0|0.742|1.27|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall) for the R-106583 metabolite.|||1.27|0.742|
73866061|NCT01178099|147278347|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.815|||||TWO_SIDED|90.0|0.633|1.05|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD for the R-106583 metabolite.|||1.05|0.633|
73866062|NCT01178099|147278347|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.952|||||TWO_SIDED|90.0|0.658|1.38|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 5 mg MD for the R-106583 metabolite.|||1.38|0.658|
73866063|NCT01178099|147278347|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.17|||||TWO_SIDED|90.0|0.833|1.65|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.|||1.65|0.833|
73866064|NCT01178099|147278347|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.07|||||TWO_SIDED|90.0|0.779|1.48|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-119251 metabolite.|||1.48|0.779|
73934775|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.611|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.611
73934776|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.424|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.424
73934777|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.991|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.991
73934778|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.185|TWO_SIDED|95.0|-1.3|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.3|0.185
73972560|NCT00429364|147486769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.20
73972561|NCT00429364|147486770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.15
73972562|NCT00429364|147486771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.30
73972563|NCT00429364|147486772|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||<0.001
73972564|NCT00429364|147486773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.002
73866065|NCT01178099|147278347|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.813|||||TWO_SIDED|95.0|0.51|1.3|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-119251 metabolite.|||1.30|0.510|
73934779|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.597|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.0|0.597
73972565|NCT00429364|147486774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.29
73972566|NCT00429364|147486775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED|||||Regression model adjusted for age at study visit.|Mixed Models Analysis|||||||0.96
73972567|NCT00429364|147486776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
73972568|NCT00429364|147486777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
73972569|NCT00429364|147486778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65|TWO_SIDED||||||Mixed Models Analysis|||||||0.65
73972570|NCT00429364|147486779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
73972571|NCT00429364|147486780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|TWO_SIDED||||||Mixed Models Analysis|||||||0.82
73972572|NCT00429364|147486781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
73972573|NCT00429364|147486782|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
73866066|NCT01178099|147278348|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.018
73934780|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.09|TWO_SIDED|95.0|-1.5|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.5|0.090
73934781|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.686|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.9|0.686
73934782|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.501|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.0|0.501
73972574|NCT00429364|147486783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
73972575|NCT00429364|147486785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||Log Rank|||||||0.16
73972576|NCT00429364|147486787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Log Rank|||||||0.13
73972577|NCT00429364|147486789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|TWO_SIDED||||||Log Rank|||||||0.32
73972578|NCT00429364|147486791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED||||||Log Rank|||||||0.10
73972579|NCT00661141|147486823|SUPERIORITY|||||||0.8727||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort||||0.8727
73972580|NCT00661141|147486826|SUPERIORITY|||||||0.0023||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort||||0.0023
73972581|NCT00661141|147486826|SUPERIORITY|||||||0.386||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort||||0.386
73972582|NCT00661141|147486826|SUPERIORITY|||||||0.0006||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg, 5.0 mg/kg||||0.0006
73972583|NCT00661141|147486826|SUPERIORITY|||||||0.0154||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||3.0 mg/kg, 5.0 mg/kg||||0.0154
73972584|NCT00661141|147486833|SUPERIORITY||ratio of parameter means|115.57|||||TWO_SIDED|90.0|90.45|147.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||147.67|90.45|
74088849|NCT00484419|147730840|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
73934783|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.764|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.6|0.764
73972585|NCT00661141|147486833|SUPERIORITY||ratio of parameter means|126.05|||||TWO_SIDED|90.0|101.94|155.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||155.87|101.94|
73972586|NCT00661141|147486833|SUPERIORITY||ratio of parameter means|137.58|||||TWO_SIDED|90.0|115.66|163.65|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||163.65|115.66|
73934784|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.715|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.9|0.715
73934785|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.924|TWO_SIDED|95.0|-0.7|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.7|0.924
73934786|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.264|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.2|0.264
73934787|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.976|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.7|0.976
73934788|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.626|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.9|0.626
73934789|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.925|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.925
73934790|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.849|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.0|0.849
73934791|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.755|TWO_SIDED|95.0|-0.7|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.7|0.755
73972587|NCT00661141|147486833|SUPERIORITY||ratio of parameter means|82.4|||||TWO_SIDED|90.0|62.83|108.07|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||108.07|62.83|
73972588|NCT00661141|147486833|SUPERIORITY||ratio of parameter means|115.25|||||TWO_SIDED|90.0|91.19|145.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||145.67|91.19|
73972589|NCT00661141|147486833|SUPERIORITY||ratio of parameter means|112.64|||||TWO_SIDED|90.0|96.14|131.98|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||131.98|96.14|
73972590|NCT00661141|147486836|SUPERIORITY||ratio of parameter means|139.63|||||TWO_SIDED|90.0|92.18|211.51|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||211.51|92.18|
73972591|NCT00661141|147486836|SUPERIORITY||ratio of parameter means|120.76|||||TWO_SIDED|90.0|108.8|134.03|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||134.03|108.80|
73972592|NCT00661141|147486836|SUPERIORITY||ratio of parameter means|143.39|||||TWO_SIDED|90.0|107.72|190.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||190.87|107.72|
73972593|NCT00661141|147486836|SUPERIORITY||ratio of parameter means|103.13|||||TWO_SIDED|90.0|84.35|126.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||126.10|84.35|
73934792|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.863|TWO_SIDED|95.0|-0.8|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.8|0.863
73934793|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.477|TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.5|0.477
73934794|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.432|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.0|0.432
73934795|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.909|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.909
73934796|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.812|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.812
73934797|NCT00406029|147399256|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.54|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.5|0.540
73934798|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.829|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.7|0.829
73934799|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.042|TWO_SIDED|95.0|0.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|0.0|0.042
73972594|NCT00661141|147486836|SUPERIORITY||ratio of parameter means|123.17|||||TWO_SIDED|90.0|108.61|139.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||139.67|108.61|
73972595|NCT00661141|147486836|SUPERIORITY||ratio of parameter means|137.17|||||TWO_SIDED|90.0|123.3|152.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||152.59|123.30|
74030448|NCT02078713|147615162|SUPERIORITY||Odds Ratio (OR)|0.59||||0.002|TWO_SIDED|95.0|0.42|0.82||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on female sterilization/tubal ligation. Patients were excluded from this analysis if they reported not having heard of female sterilization/tubal ligation in the post-visit survey.||0.82|0.42|0.002
73934800|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.204|TWO_SIDED|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.3|0.204
73934801|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.035|TWO_SIDED|95.0|0.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|0.1|0.035
73934802|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.696|TWO_SIDED|94.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.2|0.696
73934803|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.625|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.625
73934804|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.478|TWO_SIDED|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.6|0.478
73934805|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.38|TWO_SIDED|95.0|-0.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.5|0.380
73934806|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.925|TWO_SIDED|95.0|-1.2|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.2|0.925
73972596|NCT00661141|147486838|SUPERIORITY||ratio of parameter means|121.81|||||TWO_SIDED|90.0|108.42|136.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||136.84|108.42|
73866067|NCT01178099|147278349|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.060
73934807|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.285|TWO_SIDED|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.5|0.285
73934808|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.296|TWO_SIDED|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.5|0.296
73934809|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.241|TWO_SIDED|95.0|-0.5|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.5|0.241
73934810|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.571|TWO_SIDED|95.0|-0.9|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.9|0.571
73934811|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.032|TWO_SIDED|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.1|0.032
73934812|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.214|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.4|0.214
73934813|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.051|TWO_SIDED|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.0|0.051
73934814|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.572|TWO_SIDED|95.0|-0.9|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-0.9|0.572
73934815|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.041|TWO_SIDED|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.1|0.041
73934816|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.24|TWO_SIDED|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.5|0.240
73934817|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.047|TWO_SIDED|95.0|0.0|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.0|0.047
73934818|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.228|TWO_SIDED|95.0|-0.5|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.5|0.228
73934819|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.03|TWO_SIDED|95.0|0.1|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|0.1|0.030
73934820|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.059|TWO_SIDED|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.0|0.059
73934821|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|1.5||||0.021|TWO_SIDED|95.0|0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|0.2|0.021
73934822|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.428|TWO_SIDED|95.0|-0.6|1.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-0.6|0.428
73972597|NCT00661141|147486838|SUPERIORITY||ratio of parameter means|123.7|||||TWO_SIDED|90.0|93.55|163.56|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||163.56|93.55|
73972598|NCT00661141|147486838|SUPERIORITY||ratio of parameter means|150.33|||||TWO_SIDED|90.0|93.14|242.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||242.63|93.14|
73934823|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.025|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.025
73934824|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|1.0||||0.064|TWO_SIDED|95.0|-0.1|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.1|0.064
74039408|NCT04847141|147632412|SUPERIORITY||LS Mean (LSM) Difference|0.02||||0.8555|TWO_SIDED|95.0|-0.23|0.27|||ANCOVA||95% CI for difference in LSM between 1 g C19-IG 20% \& placebo was calculated using an ANCOVA model,with number of days on oxygen as dependent variable \& treatment group as fixed effect,adjusting for baseline characteristics(including age \& gender).|||0.27|-0.23|0.8555
73972599|NCT00661141|147486838|SUPERIORITY||ratio of parameter means|122.83|||||TWO_SIDED|90.0|82.45|183.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analysis for Cohort 3 where all available data were included.||183.00|82.45|
73972600|NCT00661141|147486844|SUPERIORITY||ratio of parameter means|69.13|||||TWO_SIDED|90.0|48.88|97.78|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||97.78|48.88|
73972601|NCT00661141|147486844|SUPERIORITY||ratio of parameter means|124.46|||||TWO_SIDED|90.0|88.77|174.5|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||174.50|88.77|
73934825|NCT00406029|147399257|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.047|TWO_SIDED|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|0.0|0.047
73934826|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.345|TWO_SIDED|95.0|-1.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.4|0.345
73934827|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.468|TWO_SIDED|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.6|0.468
73934828|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.596|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.596
73934829|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.107|TWO_SIDED|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.2|0.107
73934830|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.348|TWO_SIDED|94.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.8|0.348
73934831|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.938|TWO_SIDED|95.0|-1.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.1|0.938
73934832|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.897|TWO_SIDED|95.0|-1.1|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.1|0.897
73866068|NCT01178099|147278350|SUPERIORITY_OR_OTHER|||||||0.219||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.219
73934833|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.518|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.518
73934834|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.311|TWO_SIDED|95.0|-2.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-2.2|0.311
73972602|NCT00661141|147486844|SUPERIORITY||ratio of parameter means|105.31|||||TWO_SIDED|90.0|89.24|124.27|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||124.27|89.24|
73934835|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.597|TWO_SIDED|95.0|-1.0|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.0|0.597
73934836|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.925|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.5|0.925
73934837|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.478|TWO_SIDED|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.9|0.478
73934838|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.995|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.5|0.995
73972603|NCT00661141|147486844|SUPERIORITY||ratio of parameter means|88.6|||||TWO_SIDED|90.0|56.66|138.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||138.54|56.66|
73972604|NCT00661141|147486844|SUPERIORITY||ratio of parameter means|70.77|||||TWO_SIDED|90.0|34.16|146.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||146.59|34.16|
73972605|NCT00661141|147486844|SUPERIORITY||ratio of parameter means|86.04|||||TWO_SIDED|90.0|55.78|132.73|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||132.73|55.78|
73972606|NCT00661141|147486847|SUPERIORITY||ratio of parameter means|90.2|||||TWO_SIDED|90.0|69.54|117.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||117.00|69.54|
73972607|NCT00661141|147486847|SUPERIORITY||ratio of parameter means|112.28|||||TWO_SIDED|90.0|103.72|121.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||121.54|103.72|
73866069|NCT01178099|147278351|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.177
73934839|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.057|TWO_SIDED|95.0|0.0|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|0.0|0.057
73934840|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.431|TWO_SIDED|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.9|0.431
73934841|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.099|TWO_SIDED|95.0|-0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|-0.2|0.099
73972608|NCT00661141|147486847|SUPERIORITY||ratio of parameter means|106.08|||||TWO_SIDED|90.0|96.81|116.24|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||116.24|96.81|
73972609|NCT00661141|147486847|SUPERIORITY||ratio of parameter means|104.12|||||TWO_SIDED|90.0|83.5|129.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||129.84|83.50|
73972610|NCT00661141|147486847|SUPERIORITY||ratio of parameter means|100.41|||||TWO_SIDED|90.0|77.86|129.49|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||129.49|77.86|
73866070|NCT01178099|147278352|SUPERIORITY_OR_OTHER|||||||0.168||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.168
73934842|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.847|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.5|0.847
73934843|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.093|TWO_SIDED|95.0|-0.2|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-0.2|0.093
73934844|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.471|TWO_SIDED|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.9|0.471
73934845|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.102|TWO_SIDED|95.0|-0.2|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|-0.2|0.102
73934846|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.415|TWO_SIDED|95.0|-0.9|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-0.9|0.415
73934847|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|1.5||||0.051|TWO_SIDED|95.0|0.0|3.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.0|0.0|0.051
73934848|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.103|TWO_SIDED|95.0|-0.3|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-0.3|0.103
73934849|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.022|TWO_SIDED|95.0|0.3|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.2|0.3|0.022
73934850|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.903|TWO_SIDED|95.0|-1.2|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.2|0.903
73972611|NCT00661141|147486847|SUPERIORITY||ratio of parameter means|94.7|||||TWO_SIDED|90.0|82.7|108.42|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||108.42|82.70|
73972612|NCT00661141|147486849|SUPERIORITY||ratio of parameter means|94.15|||||TWO_SIDED|90.0|78.01|1113.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||1113.63|78.01|
73972613|NCT00661141|147486849|SUPERIORITY||ratio of parameter means|107.05|||||TWO_SIDED|90.0|87.42|131.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||131.10|87.42|
73972614|NCT00661141|147486849|SUPERIORITY||ratio of parameter means|97.9|||||TWO_SIDED|90.0|84.84|112.97|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||112.97|84.84|
74030449|NCT02078713|147615162|SUPERIORITY||Odds Ratio (OR)|0.58||||0.005|TWO_SIDED|95.0|0.4|0.85||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on male sterilization/vasectomy. Patients were excluded from this analysis if they reported not having heard of male sterilization/vasectomy in the post-visit survey.||0.85|0.4|0.005
74030450|NCT02078713|147615163|SUPERIORITY||Odds Ratio (OR)|1.55||||0.27|TWO_SIDED|95.0|0.71|3.42||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of hormonal IUD||3.42|0.71|0.27
74088850|NCT00484419|147730840|SUPERIORITY_OR_OTHER|||||||0.0566||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0566
73934851|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.074|TWO_SIDED|95.0|-0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-0.1|0.074
73934852|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.185|TWO_SIDED|95.0|-0.4|2.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.4|0.185
73934853|NCT00406029|147399258|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.054|TWO_SIDED|95.0|0.0|2.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|0.0|0.054
73934854|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.985|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.5|0.985
73934855|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.556|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.3|0.556
73934856|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.776|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.4|0.776
74088851|NCT00484419|147730840|SUPERIORITY_OR_OTHER|||||||0.0217||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0217
74088852|NCT03095118|147730856|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Proteinuria baseline values compared to 6 month follow up values||||0.001
74088853|NCT03095118|147730857|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Proteinuria baseline values compared to 12 month follow up values||||0.004
74030451|NCT02078713|147615163|SUPERIORITY||Odds Ratio (OR)|1.65||||0.18|TWO_SIDED|95.0|0.8|3.4||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of non-hormonal IUD||3.40|0.80|0.18
73934857|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.777|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.4|0.777
73934858|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.92|TWO_SIDED|94.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.5|0.920
73934859|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.155|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.1|0.155
73934860|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.843|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.843
73934861|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.673|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.4|0.673
73934862|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.612|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.612
73934863|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.512|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.4|0.512
73934864|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.269|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.269
73934865|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.516|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.516
73934866|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.597|TWO_SIDED|95.0|-0.8|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.8|0.597
73934867|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.766|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.7|0.766
73934868|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.428|TWO_SIDED|95.0|-0.9|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.9|0.428
73934869|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.796|TWO_SIDED|95.0|-0.7|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.7|0.796
73934870|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.988|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.988
73934871|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.786|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.786
73934872|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.702|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.702
73934873|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.371|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.3|0.371
73934874|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.981|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.981
73934875|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.282|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.3|0.282
73934876|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.55|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.550
73934877|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.72|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.720
73934878|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.742|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.742
73934879|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.211|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.2|0.211
73934880|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.906|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.6|0.906
73934881|NCT00406029|147399259|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.868|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.868
73934882|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.747|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.6|0.747
73934883|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.14|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.140
73934884|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.148|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.148
73934885|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.005|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-1.2|0.005
73934886|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.256|TWO_SIDED|94.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.8|0.256
73934887|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.343|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.343
73934888|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.102|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.0|0.102
73934889|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.161|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.161
73934890|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.15|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.150
73934891|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.175|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.175
73934892|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.013|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-1.2|0.013
73934893|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.12|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.120
73934894|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.971|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.971
74008324|NCT03627767|147566502|SUPERIORITY||LSM difference|-1.5|||||TWO_SIDED|95.0|-2.4|-0.6||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-2.4|
74088854|NCT03095118|147730859|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Serum creatinine baseline values compared to 6 month follow up values||||0.15
73934895|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.456|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.7|0.456
73934896|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.018|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-1.2|0.018
73934897|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.175|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.175
73934898|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.422|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.3|0.422
73934899|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.651|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.4|0.651
73934900|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.096|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.0|0.096
73934901|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.86|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.860
73934902|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.511|TWO_SIDED|95.0|-0.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.8|0.511
74088855|NCT03095118|147730860|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Serum creatinine baseline values comparted to 12 month follow up values||||0.16
74088856|NCT02646917|147730890|SUPERIORITY||||||<|0.008|||||||Wilcoxon (Mann-Whitney)|||Goodman and Baron's qualitative acne scar severity scores. Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean change from baseline is equal to zero.||||<0.008
73934903|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.286|TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.9|0.286
73934904|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.004|TWO_SIDED|95.0|-1.4|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-1.4|0.004
73934905|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.06|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.1|0.060
73934906|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.345|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.345
73934907|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.439|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.7|0.439
73934908|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.004|TWO_SIDED|95.0|-1.4|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.4|0.004
73934909|NCT00406029|147399266|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.04|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.1|0.040
73934910|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.743|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.1|0.743
73934911|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.225|TWO_SIDED|95.0|-2.2|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.2|0.225
73934912|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.252|TWO_SIDED|95.0|-2.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-2.2|0.252
73934913|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.173|TWO_SIDED|95.0|-2.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-2.3|0.173
73934914|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.757|TWO_SIDED|94.0|-1.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.3|0.757
73934915|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.581|TWO_SIDED|95.0|-1.1|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.1|0.581
73934916|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.195|TWO_SIDED|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.5|0.195
73934917|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.272|TWO_SIDED|95.0|-2.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-2.4|0.272
73934918|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.758|TWO_SIDED|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.7|0.758
73934919|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.416|TWO_SIDED|95.0|-2.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-2.1|0.416
73934920|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.174|TWO_SIDED|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.5|0.174
73934921|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.547|TWO_SIDED|95.0|-1.1|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-1.1|0.547
73934922|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.372|TWO_SIDED|95.0|-0.8|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.8|0.372
73934923|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.942|TWO_SIDED|95.0|-1.4|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.4|0.942
73934924|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.082|TWO_SIDED|95.0|-2.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-2.8|0.082
73934925|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.267|TWO_SIDED|95.0|-2.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-2.3|0.267
73934926|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.801|TWO_SIDED|95.0|-1.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.5|0.801
74088857|NCT02646917|147730891|SUPERIORITY||||||<|0.001|||||||Wilcoxen signed-rank test|||Null hypothesis 4 (no change).||||<.001
74088858|NCT02646917|147730892|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean change from baseline is equal to zero||||<0.01
73934927|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.753|TWO_SIDED|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.9|0.753
73934928|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.087|TWO_SIDED|95.0|-3.1|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-3.1|0.087
73934929|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.796|TWO_SIDED|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.9|0.796
73934930|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.621|TWO_SIDED|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.3|0.621
73934931|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.784|TWO_SIDED|95.0|-1.8|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.8|0.784
73934932|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9||||0.024|TWO_SIDED|95.0|-3.5|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-3.5|0.024
73934933|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.963|TWO_SIDED|95.0|-1.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.6|0.963
73934934|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.331|TWO_SIDED|95.0|-0.8|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-0.8|0.331
73934935|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.898|TWO_SIDED|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.4|0.898
73934936|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.058|TWO_SIDED|95.0|-3.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-3.0|0.058
73934937|NCT00406029|147399267|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.832|TWO_SIDED|95.0|-1.3|1.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.3|0.832
73934938|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.365|TWO_SIDED|95.0|-2.0|5.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.3|-2.0|0.365
73934939|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.476|TWO_SIDED|95.0|-2.4|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-2.4|0.476
73934940|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|1.8||||0.343|TWO_SIDED|95.0|-2.0|5.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.6|-2.0|0.343
73934941|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.103|TWO_SIDED|95.0|-6.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-6.8|0.103
73972615|NCT05280574|147486875|OTHER||Ratio of geometric means|0.75|||<|0.05|TWO_SIDED|95.0|0.51|1.1|||Distinct-effects GEE model||Average relative effect of unblinded versus blinded monitoring across the 5-component composite (SpO2 \<85%, RR \>30/min, RR \<4/min, HR \<45/min, HR \>130/min) of cumulative durations.||We assessed the treatment effect of unblinded versus blinded monitoring across the 5-component primary outcome composite of cumulative durations by estimating the average relative effect on the log-transformed count data (counts of observations beyond a given threshold at 1 Hz). Specifically, we employed a distinct-effects (i.e., separate treatment effect estimated for each component) generalized estimating equation (GEE) model to account for within-subject correlation across components with the vector of the 5 cumulative durations as the dependent variable and treatment as independent. We then averaged the component-specific effects and tested whether the average effect equals zero (on the log scale), and reported results as the ratio of geometric means of unblinded versus blinded monitoring.|1.1|0.51|< 0.05
73972616|NCT05237284|147486886|SUPERIORITY|||||||0.6999|||||||Wilcoxon (Mann-Whitney)|||CAFS at Week 24 was analyzed using the Wilcoxon-Mann-Whitney test to compare mean scores between the treatment groups at Week 24.||||0.6999
73934942|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3||||0.224|TWO_SIDED|94.0|-6.0|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-6.0|0.224
73934943|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.448|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-5.1|0.448
73934944|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7||||0.154|TWO_SIDED|95.0|-6.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-6.4|0.154
73934945|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.8||||0.01|TWO_SIDED|95.0|-8.5|-1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-1.1|-8.5|0.010
73934946|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.54|TWO_SIDED|95.0|-2.6|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.0|-2.6|0.540
73934947|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.646|TWO_SIDED|95.0|-4.7|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-4.7|0.646
73934948|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.608|TWO_SIDED|95.0|-4.9|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-4.9|0.608
73934949|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9||||0.343|TWO_SIDED|95.0|-6.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-6.0|0.343
73934950|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.419|TWO_SIDED|95.0|-2.5|5.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.9|-2.5|0.419
73934951|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.562|TWO_SIDED|95.0|-2.8|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-2.8|0.562
73934952|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.525|TWO_SIDED|95.0|-5.3|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|-5.3|0.525
73934953|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.0||||0.148|TWO_SIDED|95.0|-7.0|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-7.0|0.148
73934954|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.546|TWO_SIDED|95.0|-5.4|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-5.4|0.546
73934955|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.7||||0.068|TWO_SIDED|95.0|-7.6|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-7.6|0.068
73934956|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.5||||0.208|TWO_SIDED|95.0|-6.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-6.5|0.208
73934957|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.4||||0.099|TWO_SIDED|95.0|-7.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-7.5|0.099
73972617|NCT05237284|147486889|SUPERIORITY||LS Mean Difference|0.52||||0.2182|TWO_SIDED|95.0|-0.31|1.35|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline ALSFRS-R score, baseline NfL, disease duration-by-visit interaction, and baseline ALSFRS-R score-by-visit interaction.||1.350|-0.310|0.2182
73972618|NCT05237284|147486890|SUPERIORITY||LS Mean Difference|0.419||||0.8134|TWO_SIDED|95.0|-3.075|3.914|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline SVC, baseline NfL, disease duration-by-visit interaction, baseline NfL-by-visit interaction, and baseline SVC-by-visit interaction.||3.914|-3.075|0.8134
73934958|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.731|TWO_SIDED|95.0|-3.6|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-3.6|0.731
73934959|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.861|TWO_SIDED|95.0|-4.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-4.5|0.861
73934960|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.621|TWO_SIDED|95.0|-5.2|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.1|-5.2|0.621
73934961|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2||||0.288|TWO_SIDED|95.0|-6.4|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-6.4|0.288
73934962|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.861|TWO_SIDED|95.0|-3.5|4.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||4.1|-3.5|0.861
73934963|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.954|TWO_SIDED|95.0|-4.0|3.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-4.0|0.954
73934964|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.6||||0.419|TWO_SIDED|95.0|-5.5|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-5.5|0.419
73934965|NCT00406029|147399268|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.2||||0.088|TWO_SIDED|95.0|-6.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-6.9|0.088
74008325|NCT03627767|147566502|SUPERIORITY||LSM difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.7|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.7|-5.3|< 0.0001
74008326|NCT03627767|147566502|SUPERIORITY||LSM difference|-5.2|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.9|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.9|-6.4|< 0.0001
73934966|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.924|TWO_SIDED|95.0|-3.5|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.2|-3.5|0.924
73934967|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.84|TWO_SIDED|95.0|-3.8|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.1|-3.8|0.840
73934968|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.599|TWO_SIDED|95.0|-4.4|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-4.4|0.599
73934969|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.6||||0.134|TWO_SIDED|95.0|-6.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-6.0|0.134
73934970|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.846|TWO_SIDED|94.0|-4.1|3.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.3|-4.1|0.846
73934971|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.467|TWO_SIDED|95.0|-2.3|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.0|-2.3|0.467
73934972|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.533|TWO_SIDED|95.0|-4.8|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-4.8|0.533
73934973|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.094|TWO_SIDED|95.0|-6.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-6.7|0.094
73972619|NCT05237284|147486891|SUPERIORITY||Ratio of the LS Geometric Mean Ratios|0.961||||0.2356|TWO_SIDED|95.0|0.899|1.027|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, log transformed baseline NfL, disease duration-by-visit interaction, and log transformed baseline NfL-by-visit interaction.||1.027|0.899|0.2356
73972620|NCT05237284|147486892|SUPERIORITY||LS Mean difference|-0.005||||0.9565|TWO_SIDED|95.0|-0.193|0.183|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline megascore, baseline NfL, disease duration-by-visit interaction, baseline NfL-by-visit interaction and baseline megascore-by-visit interaction.||0.183|-0.193|0.9565
73972621|NCT05237284|147486897|SUPERIORITY||Least Square (LS) Mean Difference|-0.414||||0.5289|TWO_SIDED|95.0|-1.706|0.878|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline ALSFRS-R score, baseline serum neurofilament light chain (NfL), disease duration-by-visit interaction, baseline NfL-by-visit interaction and baseline ALSFRS-R score-by-visit interaction.||0.878|-1.706|0.5289
73934974|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.994|TWO_SIDED|95.0|-3.7|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-3.7|0.994
74088859|NCT02646917|147730893|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean score is equal to 0 (no change in the appearance of acne scars).||||<0.01
74088860|NCT02646917|147730894|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean score is equal to 4 (no change).||||||<0.01
73934975|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.944|TWO_SIDED|95.0|-3.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-3.5|0.944
73934976|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.424|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-5.1|0.424
73934977|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.0||||0.042|TWO_SIDED|95.0|-7.8|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-7.8|0.042
73934978|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|3.7||||0.075|TWO_SIDED|95.0|-0.4|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||7.8|-0.4|0.075
73934979|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|3.9||||0.052|TWO_SIDED|95.0|0.0|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||7.8|0.0|0.052
73934980|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.975|TWO_SIDED|95.0|-4.0|3.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.9|-4.0|0.975
73934981|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.541|TWO_SIDED|95.0|-5.2|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-5.2|0.541
73934982|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.931|TWO_SIDED|95.0|-4.1|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-4.1|0.931
73934983|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.618|TWO_SIDED|95.0|-4.7|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-4.7|0.618
73934984|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.8||||0.341|TWO_SIDED|95.0|-5.6|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-5.6|0.341
73934985|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2||||0.256|TWO_SIDED|95.0|-6.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-6.0|0.256
73934986|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|1.8||||0.399|TWO_SIDED|95.0|-2.4|6.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||6.0|-2.4|0.399
73934987|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.477|TWO_SIDED|95.0|-2.5|5.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.4|-2.5|0.477
73934988|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.8||||0.172|TWO_SIDED|95.0|-6.8|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-6.8|0.172
73934989|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3||||0.254|TWO_SIDED|95.0|-6.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-6.2|0.254
73934990|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.972|TWO_SIDED|95.0|-3.6|3.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-3.6|0.972
73934991|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.891|TWO_SIDED|95.0|-3.5|4.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||4.0|-3.5|0.891
73934992|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.8||||0.143|TWO_SIDED|95.0|-6.6|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-6.6|0.143
73934993|NCT00406029|147399269|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.2||||0.083|TWO_SIDED|95.0|-6.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-6.8|0.083
73934994|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.154|TWO_SIDED|95.0|-0.2|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.2|0.154
73934995|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.38|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.4|0.380
74030452|NCT02078713|147615163|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5|TWO_SIDED|95.0|0.62|2.69||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of implant||2.69|0.62|0.5
73934996|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.288|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.3|0.288
73934997|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.355|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.4|0.355
73934998|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.831|TWO_SIDED|94.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.831
73934999|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.198|TWO_SIDED|95.0|-1.2|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-1.2|0.198
73935000|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.792|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.8|0.792
73935001|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.749|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.8|0.749
73935002|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.896|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.896
73935003|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.5|0.480
73935004|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.285|TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.4|0.285
73935005|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.212|TWO_SIDED|95.0|-0.3|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.3|0.212
73935006|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.883|TWO_SIDED|95.0|-0.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.9|0.883
73935007|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.947|TWO_SIDED|95.0|-0.9|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.9|0.947
73935008|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.663|TWO_SIDED|95.0|-1.1|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.1|0.663
73935009|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.157|TWO_SIDED|95.0|-0.3|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.3|0.157
73935010|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.283|TWO_SIDED|95.0|-1.4|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.4|0.283
73935011|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.768|TWO_SIDED|95.0|-1.0|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.0|0.768
73935012|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.334|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.3|0.334
73935013|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.465|TWO_SIDED|95.0|-1.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.2|0.465
73935014|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.688|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.2|0.688
73935015|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.062|TWO_SIDED|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|0.0|0.062
73935016|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.579|TWO_SIDED|95.0|-1.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.2|0.579
73935017|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.644|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.644
73935018|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.825|TWO_SIDED|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.8|0.825
73935019|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.233|TWO_SIDED|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.3|0.233
73935020|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.853|TWO_SIDED|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.8|0.853
73935021|NCT00406029|147399270|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.592|TWO_SIDED|95.0|-0.6|1.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.6|0.592
73935022|NCT03669081|147399293|OTHER|The null hypothesis for the test was no difference between groups.||||||0.006||||||The significance level for this test was 0.05.|Wilcoxon (Mann-Whitney)|We used an exact Wilcoxon rank sum test due to the skewed nature of the morphine equivalents data and the small sample sizes in each group.||||||0.006
73935023|NCT03669081|147399294|OTHER|The null hypothesis was no difference between groups.||||||0.029|||||||Exact Wilcoxon rank sum test|||||||0.029
73935024|NCT03669081|147399295|NON_INFERIORITY|We conducted a 1-sided non-inferiority test using an alpha level of 0.025, for a comparison of the fold change of creatinine levels (pre-operative creatinine/post-operative creatinine) in the Toradol group. Our minimum non-inferiority margin was 0.5, ie the post-operative creatinine level could only increase to at most two times the pre-operative creatinine level.|||||<|0.0001||||||This p-value was compared to a significance threshold of 0.025.|Wilcoxon (Mann-Whitney)|||The safety outcome was used to power our study.To achieve 90% power at a 2.5% significance level for testing that the post-surgery creatinine increase is at most two-fold (where 1.5 fold is expected), or alternatively for the pre-surgery creatinine group to be ≥0.5 times the post-surgery, we need 17 subjects in the toradol group. This calculation was based on a non-inferiority test (one sided t-test) using a coefficient of variation of 0.25 based on preliminary data.||||<0.0001
73935025|NCT03669081|147399296|OTHER|The null hypothesis was no difference between groups.||||||0.002|||||||t-test, 2 sided|||||||0.002
73935026|NCT03669081|147399297|OTHER|The null hypothesis was no difference between groups.|||||>|0.99|||||||Fisher Exact|||||||>0.99
73972622|NCT05237284|147486898|SUPERIORITY|||||||0.183|||||||ANCOVA|||Analysis was performed using rank analysis of covariance (ANCOVA) model including treatment group, randomization strata of the geographic region of the study site, ALS onset region (bulbar or other areas), use of riluzole (yes or no), use of edaravone (yes or no), use of the combination of sodium phenylbutyrate and taurursodiol (yes or no), disease duration (from first symptom onset to the screening visit), baseline ALSFRS-R score and baseline NfL.||||0.1830
73972623|NCT01866163|147486988|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|30.27|||<|0.001|TWO_SIDED|95.0|9.72|94.3|||Mantel Haenszel|||Multiple imputations were used to handle missing data.||94.30|9.72|<0.001
73972624|NCT01866163|147486989|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.28|||<|0.001|TWO_SIDED|95.0|-3.9|-2.67|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.||-2.67|-3.90|<0.001
73972625|NCT01866163|147486990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.76|-0.78|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.||-0.78|-1.76|<0.001
73935027|NCT00389324|147399299|NON_INFERIORITY_OR_EQUIVALENCE|The administration effect between SC and IV was assessed by exponentiation of the difference in least squares means between study phases (Test minus Reference) and the corresponding 90% confidence interval (CI) for the geometric LSM ratio between study phases (Test/Reference) for AUC. The Test (SC) was to be considered non-inferior to Reference (IV) if the lower bound of 90% CIs for the geometric LSM ratios of AUC between the Test and Reference was above 0.80 (80%).|Geometric Least Square Mean Ratio|0.888||||||90.0|0.861|0.917|||ANOVA||An adjusted steady-state area under the concentration vs. time curve following SC administration based on IV dosing schedule was calculated as AUC0-τ,SC multiplied by 3 or 4 for subjects on every-3-week or every-4-week IV dosing schedule.|The IV phase was considered as the Reference study phase and the SC phase as the Test study phase. The ANOVA included calculation of least-squares means (LSM), differences between adjusted means and the standard error associated with these differences.||0.917|0.861|
73935028|NCT04079933|147399315|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL|Mean Difference (Net)|-12.6||||0.2347|TWO_SIDED|95.0|-33.5|8.27|||t-test, 2 sided||"Difference in Least Square (LS) means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL||8.27|-33.5|0.2347
73935029|NCT04079933|147399315|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL|Mean Difference (Net)|-11.9||||0.2905|TWO_SIDED|95.0|-33.9|10.2|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL||10.2|-33.9|0.2905
73935030|NCT04079933|147399316|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL|Mean Difference (Net)|-3.72||||0.9433|TWO_SIDED|95.0|-107.0|99.4|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL||99.4|-107|0.9433
73935031|NCT04079933|147399316|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL|Mean Difference (Net)|-12.2||||0.8264|TWO_SIDED|95.0|-122.0|97.5|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL||97.5|-122|0.8264
73935032|NCT04079933|147399317|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents|Mean Difference (Net)|-1.13||||0.4903|TWO_SIDED|95.0|-4.35|2.1|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents||2.10|-4.35|0.4903
73957833|NCT03068468|147451202|SUPERIORITY||Difference|-0.021||||0.9527|TWO_SIDED|95.0|-0.726|0.684|||MMRM|||Ventricles Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.684|-0.726|0.9527
73972626|NCT02998528|147487023|SUPERIORITY||Cox Proportional Hazard|0.63||||0.0052|TWO_SIDED|97.38|0.43|0.91|||Log Rank|Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)||||0.91|0.43|0.0052
73972627|NCT02998528|147487024|SUPERIORITY||% Difference|21.6|||||TWO_SIDED|99.0|13.0|30.3|||||Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||30.3|13.0|
73972628|NCT02998528|147487024|SUPERIORITY||Odds Ratio (OR)|13.94|||<|0.0001|TWO_SIDED|99.0|3.49|55.75|||Cochran-Mantel-Haenszel||Strata adjusted odds ratio (Arm C over Concurrent Arm B) the Mantel-Haenszel method. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||55.75|3.49|<0.0001
74030453|NCT02078713|147615163|SUPERIORITY||Odds Ratio (OR)|1.7||||0.32|TWO_SIDED|95.0|0.59|4.89||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of the patch||4.89|0.59|0.32
73866071|NCT01178099|147278353|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.5|||||TWO_SIDED|90.0|1.01|2.22|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.|||2.22|1.01|
73866072|NCT01178099|147278353|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.09|||||TWO_SIDED|90.0|0.751|1.58|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-95913 metabolite.|||1.58|0.751|
73866073|NCT01178099|147278353|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.87|||||TWO_SIDED|90.0|1.09|3.2|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-95913 metabolite.|||3.20|1.09|
73935033|NCT04079933|147399317|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents|Mean Difference (Net)|-1.4||||0.4251|TWO_SIDED|95.0|-4.88|2.07|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents||2.07|-4.88|0.4251
73935034|NCT04079933|147399318|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents|Mean Difference (Net)|-9.83||||0.406|TWO_SIDED|95.0|-33.2|13.5|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents||13.5|-33.2|0.4060
73935035|NCT04079933|147399318|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents|Mean Difference (Net)|-10.3||||0.4165|TWO_SIDED|95.0|-35.4|14.7|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents||14.7|-35.4|0.4165
73935036|NCT04079933|147399319|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA|Mean Difference (Net)|-269.0||||0.724|TWO_SIDED|95.0|-1773.0|1235.0|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA||1235|-1773|0.7240
73935037|NCT04079933|147399319|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA|Mean Difference (Net)|50.5||||0.9508|TWO_SIDED|95.0|-1566.0|1667.0|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA||1667|-1566|0.9508
73866074|NCT01178099|147278353|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.873|||||TWO_SIDED|90.0|0.66|1.15|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-106583 metabolite.|||1.15|0.660|
73866075|NCT01178099|147278353|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.681|||||TWO_SIDED|90.0|0.524|0.886|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-106583 metabolite.|||0.886|0.524|
73866076|NCT01178099|147278353|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.898|||||TWO_SIDED|90.0|0.612|1.32|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-106583 metabolite.|||1.32|0.612|
73866077|NCT01178099|147278353|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.06|||||TWO_SIDED|90.0|0.773|1.46|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.|||1.46|0.773|
73866078|NCT01178099|147278353|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.785|||||TWO_SIDED|90.0|0.582|1.06|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-119251 metabolite.|||1.06|0.582|
73866079|NCT01178099|147278353|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.0|||||TWO_SIDED|90.0|0.648|1.55|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-119251 metabolite.|||1.55|0.648|
73866080|NCT01178099|147278354|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.060
73935038|NCT04079933|147399320|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA|Mean Difference (Net)|-19.0||||0.1524|TWO_SIDED|95.0|-45.1|7.12|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA||7.12|-45.1|0.1524
73935039|NCT04079933|147399320|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA|Mean Difference (Net)|-12.1||||0.4014|TWO_SIDED|95.0|-40.4|16.3|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA||16.3|-40.4|0.4014
73935040|NCT04079933|147399321|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin|Mean Difference (Net)|-0.507||||0.0241|TWO_SIDED|95.0|-0.946|-0.0674|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin||-0.0674|-0.946|0.0241
73935041|NCT04079933|147399321|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin|Mean Difference (Net)|-0.367||||0.1292|TWO_SIDED|95.0|-0.843|0.108|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin||0.108|-0.843|0.1292
73935042|NCT04079933|147399322|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin|Mean Difference (Net)|-10.0||||0.0333|TWO_SIDED|95.0|-19.2|-0.803|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin||-0.803|-19.2|0.0333
73935043|NCT04079933|147399322|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin|Mean Difference (Net)|-6.76||||0.1767|TWO_SIDED|95.0|-16.6|3.08|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin||3.08|-16.6|0.1767
73972629|NCT02998528|147487025|SUPERIORITY||% Difference|27.9|||||TWO_SIDED|95.0|19.6|36.1|||||Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||36.1|19.6|
73972630|NCT02998528|147487025|SUPERIORITY||Odds Ratio (OR)|5.7|||||TWO_SIDED|95.0|3.16|10.26|||||Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||10.26|3.16|
73972631|NCT02998528|147487027|SUPERIORITY||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.36|0.77|||||Stratified by: PD-L1 status (≥ 1% vs \<1%/not evaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||0.77|0.36|
73866081|NCT01178099|147278355|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||This is the p-value for PRI by flow cytometry. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error|ANCOVA|||||||0.086
73866082|NCT01178099|147278355|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||This is the p-value for PRI by ELISA. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error|ANCOVA|||||||0.679
73935044|NCT04079933|147399323|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide|Mean Difference (Net)|-1.51||||0.2961|TWO_SIDED|95.0|-4.36|1.34|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide||1.34|-4.36|0.2961
73935045|NCT04079933|147399323|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide|Mean Difference (Net)|-1.05||||0.5015|TWO_SIDED|95.0|-4.12|2.03|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide||2.03|-4.12|0.5015
73935046|NCT04079933|147399324|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide|Mean Difference (Net)|-12.1||||0.2048|TWO_SIDED|95.0|-30.9|6.68|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide||6.68|-30.9|0.2048
73935047|NCT04079933|147399324|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide|Mean Difference (Net)|-7.32||||0.4731|TWO_SIDED|95.0|-27.4|12.8|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide||12.8|-27.4|0.4731
73935048|NCT04079933|147399325|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day|Mean Difference (Net)|-3.86|||<|0.0001|TWO_SIDED|95.0|-5.25|-2.47|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day||-2.47|-5.25|<0.0001
73935049|NCT04079933|147399325|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day|Mean Difference (Net)|-3.74|||<|0.0001|TWO_SIDED|95.0|-5.14|-2.34|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day||-2.34|-5.14|<0.0001
73972632|NCT03106740|147487120|SUPERIORITY|Because relevant \[11C\]PBR28 PET imaging data were unavailable at the time of trial initiation to inform a power analysis of a treatment effect, we ran a power analysis of the treatment effect on the expected change in pain ratings based on a recent clinical trial using minocycline in subjects with back pain. We computed the sample size required for mixed effects between-subject and within-subject (Time: Pretest/Posttest) repeated measures ANOVA design. Alpha was set at 0.05 (two-tailed test).|Restricted maximum likelihood|0.0||||0.956|TWO_SIDED|95.0|-0.02|0.02||The p-value corresponds to the group-by-time interaction analysis of the primary outcome measure.|Mixed Models Analysis||Estimation parameter: Unstandardized partial regression coefficient (beta)|||0.02|-0.02|0.956
73972633|NCT04797858|147487128|SUPERIORITY||Risk Difference (RD)|0.0077||||0.45|TWO_SIDED|95.0|-0.021|0.056|||Fisher Exact|||||0.056|-0.021|0.45
73972634|NCT04797858|147487129|SUPERIORITY||Risk Difference (RD)|0.015||||0.11|TWO_SIDED|95.0|-0.0004|0.03|||Fisher Exact|||||0.03|-0.0004|0.11
73972635|NCT05256654|147487152|SUPERIORITY||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|6.92||0.691|TWO_SIDED|95.0|-15.5|11.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (Triglycerides (TG) \<250 milligram per deciliter (mg/dL) or \>=250 mg/dL at screening), and the interaction between treatment and time.|||11.9|-15.5|0.691
74030454|NCT02078713|147615163|SUPERIORITY||Odds Ratio (OR)|1.38||||0.37|TWO_SIDED|95.0|0.68|2.81||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of ring||2.81|0.68|0.37
73957834|NCT03068468|147451202|SUPERIORITY||Difference|-0.514||||0.7357|TWO_SIDED|95.0|-3.506|2.478|||MMRM|||Whole Brain Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||2.478|-3.506|0.7357
73972636|NCT05256654|147487152|SUPERIORITY||Mean Difference (Net)|-14.3|STANDARD_ERROR_OF_MEAN|4.98||0.008|TWO_SIDED|95.0|-23.6|-3.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-3.9|-23.6|0.008
73972637|NCT05256654|147487152|SUPERIORITY||Mean Difference (Net)|-8.3|STANDARD_ERROR_OF_MEAN|5.36||0.14|TWO_SIDED|95.0|-18.3|2.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.9|-18.3|0.140
73972638|NCT05256654|147487153|SUPERIORITY||Mean Difference (Net)|-54.3|STANDARD_ERROR_OF_MEAN|5.08|<|0.001|TWO_SIDED|95.0|-63.3|-43.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.1|-63.3|<.001
73972639|NCT05256654|147487153|SUPERIORITY||Mean Difference (Net)|-69.8|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-74.8|-63.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-63.9|-74.8|<.001
73972640|NCT05256654|147487153|SUPERIORITY||Mean Difference (Net)|-76.6|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-80.4|-72.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-72.0|-80.4|<.001
73972641|NCT05256654|147487154|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|7.24||0.854|TWO_SIDED|95.0|-14.6|14.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||14.0|-14.6|0.854
73972642|NCT05256654|147487154|SUPERIORITY||Mean Difference (Net)|-16.8|STANDARD_ERROR_OF_MEAN|4.98||0.002|TWO_SIDED|95.0|-26.0|-6.4|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-6.4|-26.0|0.002
74030455|NCT02078713|147615163|SUPERIORITY||Odds Ratio (OR)|1.49||||0.39|TWO_SIDED|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of male sterilization (vasectomy)||3.73|0.60|0.39
74030456|NCT02078713|147615163|SUPERIORITY||Odds Ratio (OR)|1.49||||0.39|TWO_SIDED|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of female sterilization||3.73|0.6|0.39
73972643|NCT05256654|147487154|SUPERIORITY||Mean Difference (Net)|-12.1|STANDARD_ERROR_OF_MEAN|5.28||0.033|TWO_SIDED|95.0|-21.9|-1.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-1.1|-21.9|0.033
73972644|NCT05256654|147487155|SUPERIORITY||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|4.03||0.143|TWO_SIDED|95.0|-13.8|2.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.2|-13.8|0.143
73972645|NCT05256654|147487155|SUPERIORITY||Mean Difference (Net)|-16.4|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-22.0|-10.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-10.5|-22.0|<.001
73972646|NCT05256654|147487155|SUPERIORITY||Mean Difference (Net)|-22.7|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-27.9|-17.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-17.2|-27.9|<.001
73972647|NCT05256654|147487156|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|5.55||0.068|TWO_SIDED|95.0|-21.1|0.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||0.9|-21.1|0.068
73972648|NCT05256654|147487156|SUPERIORITY||Mean Difference (Net)|-25.5|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-32.6|-17.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-17.6|-32.6|<.001
73972649|NCT05256654|147487156|SUPERIORITY||Mean Difference (Net)|-23.8|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-31.1|-15.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-15.7|-31.1|<.001
73866083|NCT01178099|147278356|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||This is the p-value for AU\*min to 6.5 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.396
73935050|NCT04079933|147399326|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day|Mean Difference (Net)|-22.5|||<|0.0001|TWO_SIDED|95.0|-30.5|-14.5|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day||-14.5|-30.5|<0.0001
73935051|NCT04079933|147399326|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day|Mean Difference (Net)|-22.3|||<|0.0001|TWO_SIDED|95.0|-30.4|-14.1|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day||-14.1|-30.4|<0.0001
73935052|NCT04079933|147399327|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence|Mean Difference (Net)|-0.408||||0.0919|TWO_SIDED|95.0|-0.884|0.0673|||t-test, 2 sided||"Difference in LS mean change between study groups using Mixed Effects Repeated Measures Model 1:~Change from baseline=study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence||0.0673|-0.884|0.0919
73935053|NCT04079933|147399327|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence|Mean Difference (Net)|-0.405||||0.0975|TWO_SIDED|95.0|-0.886|0.0751|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence||0.0751|-0.886|0.0975
73935054|NCT04079933|147399327|EQUIVALENCE|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"|Mean Difference (Net)|-8.31||||0.0643|TWO_SIDED|95.0|-17.1|0.499|||t-test, 2 sided||"Difference in LS mean percent change between study groups using Mixed Effects Repeated Measures Model 1:~Change from baseline=study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix"|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"||0.499|-17.1|0.0643
73957835|NCT03068468|147451202|SUPERIORITY||Difference|-0.004||||0.6439|TWO_SIDED|95.0|-0.023|0.014|||MMRM|||Midbrain Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.014|-0.023|0.6439
73972650|NCT05256654|147487157|SUPERIORITY||Mean Difference (Net)|-36.3|STANDARD_ERROR_OF_MEAN|5.21|<|0.001|TWO_SIDED|95.0|-45.8|-25.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-25.1|-45.8|<.001
73972651|NCT05256654|147487157|SUPERIORITY||Mean Difference (Net)|-50.3|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-56.4|-43.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.3|-56.4|<.001
73866084|NCT01178099|147278356|SUPERIORITY_OR_OTHER|||||||0.288||95.0||||This is the p-value for AU\*min to 20 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.288
73935055|NCT04079933|147399327|EQUIVALENCE|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"|Mean Difference (Net)|-8.84||||0.0517|TWO_SIDED|95.0|-17.7|0.0661|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"||0.0661|-17.7|0.0517
73935056|NCT04079933|147399328|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study|Probability|0.216||||0.216|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study||||0.2160
73935057|NCT04079933|147399328|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study|Probability|0.0648||||0.0648|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study||||0.0648
73935058|NCT04079933|147399329|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study|Probability|0.5977||||0.5977|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study||||0.5977
73866085|NCT01178099|147278356|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||This is the p-value for AU\*min to Collagen. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.095
73935059|NCT04079933|147399330|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL|Mean Difference (Net)|10.0||||0.4388|TWO_SIDED|95.0|-15.5|35.5|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL||35.5|-15.5|0.4388
73935060|NCT04079933|147399331|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites|Mean Difference (Net)|0.45||||0.339|TWO_SIDED|95.0|-0.48|1.38|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites||1.38|-0.48|0.3390
73935061|NCT04079933|147399332|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA|Mean Difference (Net)|-205.0||||0.4526|TWO_SIDED|95.0|-745.0|334.0|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA||334|-745|0.4526
73972652|NCT05256654|147487157|SUPERIORITY||Mean Difference (Net)|-52.5|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-58.4|-45.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-45.9|-58.4|<.001
73972653|NCT05256654|147487158|SUPERIORITY||Mean Difference (Net)|-38.6|STANDARD_ERROR_OF_MEAN|7.76|<|0.001|TWO_SIDED|95.0|-52.2|-21.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-21.2|-52.2|<.001
73972654|NCT05256654|147487158|SUPERIORITY||Mean Difference (Net)|-54.0|STANDARD_ERROR_OF_MEAN|4.69|<|0.001|TWO_SIDED|95.0|-62.4|-43.8|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.8|-62.4|<.001
73935062|NCT04079933|147399333|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin|Mean Difference (Net)|0.0||||0.944|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin||0.2|-0.2|0.9440
73935063|NCT04079933|147399334|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide|Mean Difference (Net)|0.0||||0.7484|TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide||1|-1|0.7484
73935064|NCT04079933|147399335|EQUIVALENCE|Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent|Mean Difference (Net)|0.0||||0.9992|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent||0|0|0.9992
73935065|NCT04079933|147399357|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study|Probability|0.1661||||0.1661|TWO_SIDED||||||Cochran-Mantel-Haenszel||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study||||0.1661
73935066|NCT04079933|147399357|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study|Probability|0.2139||||0.2139|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study||||0.2139
73935067|NCT03207750|147399369|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-D antibodies should be ≥-10%.|Difference in anti-D concentration|0.0|||||TWO_SIDED|95.0|-0.8|0.79||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-D antibodies.||0.79|-0.80|
73935068|NCT03207750|147399369|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-T antibodies should be ≥-10%.|Difference in anti-T concentration|0.0|||||TWO_SIDED|95.0|-0.79|0.77||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-T antibodies.||0.77|-0.79|
73935069|NCT03207750|147399370|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-HB antibodies should be ≥-10%.|Difference in anti-HB concentration|-0.65|||||TWO_SIDED|95.0|-1.9|0.16||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 10 mIU/mL) of anti-HB antibodies.||0.16|-1.90|
73935070|NCT03207750|147399371|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 1 antibodies should be ≥-5%.|Difference in anti-polio 1 concentration|0.21|||||TWO_SIDED|95.0|-0.6|1.15||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 1 antibodies.||1.15|-0.60|
73972655|NCT05256654|147487158|SUPERIORITY||Mean Difference (Net)|-63.6|STANDARD_ERROR_OF_MEAN|3.72|<|0.001|TWO_SIDED|95.0|-70.3|55.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||55.5|-70.3|<.001
73935071|NCT03207750|147399371|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 2 antibodies should be ≥-5%.|Difference in anti-polio 2 concentration|-0.01|||||TWO_SIDED|95.0|-1.02|0.98||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 2 antibodies.||0.98|-1.02|
73935072|NCT03207750|147399371|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 3 antibodies should be ≥-5%.|Difference in anti-polio 3 concentration|0.0|||||TWO_SIDED|95.0|-0.87|0.84||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 3 antibodies.||0.84|-0.87|
73935073|NCT03207750|147399372|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PT antibodies should be ≥ 0.67.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PT antibodies.||1.03|0.86|
73935074|NCT03207750|147399372|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-FHA antibodies should be ≥ 0.67.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.92|1.08|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-FHA antibodies.||1.08|0.92|
73935075|NCT03207750|147399372|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PRN antibodies should be ≥ 0.67.|GMC ratio|0.97|||||TWO_SIDED|95.0|0.86|1.1|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PRN antibodies.||1.10|0.86|
73935076|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 1 should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 1.||1.14|0.93|
73935077|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 3 should be ≥ 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.91|1.11|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 3.||1.11|0.91|
73935078|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 4 should be ≥ 0.5.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.9|1.09|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 4.||1.09|0.90|
73935079|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 5 should be ≥ 0.5.|GMC ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 5.||1.17|0.94|
73935080|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6A should be ≥ 0.5.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.92|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6A.||1.12|0.92|
73972656|NCT05256654|147487159|SUPERIORITY||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|5.99||0.506|TWO_SIDED|95.0|-15.2|8.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||8.5|-15.2|0.506
73935081|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6B should be ≥ 0.5.|GMC ratio|0.96|||||TWO_SIDED|95.0|0.83|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6B.||1.12|0.83|
73935082|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 7F should be ≥ 0.5.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.08|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 7F.||1.08|0.91|
73935083|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 9V should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 9V.||1.14|0.93|
73935084|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 14 should be ≥ 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 14.||1.13|0.89|
73935085|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 18C should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.92|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 18C.||1.14|0.92|
73935086|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19A should be ≥ 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.93|1.15|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19A.||1.15|0.93|
73935087|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19F should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.95|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19F.||1.12|0.95|
73935088|NCT03207750|147399373|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 23F should be ≥ 0.5.|GMC ratio|0.98|||||TWO_SIDED|95.0|0.87|1.1|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 23F.||1.10|0.87|
73935089|NCT03207750|147399374|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-5%.|Difference in anti-PRP concentration|0.17|||||TWO_SIDED|95.0|-1.94|2.28||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 0.15 µg/mL) of anti-PRP antibodies.||2.28|-1.94|
73935090|NCT03207750|147399375|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-10%.|Difference in anti-PRP concentration|-0.88|||||TWO_SIDED|95.0|-5.75|3.99||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 1.0 µg/mL) of anti-PRP antibodies.||3.99|-5.75|
73935091|NCT03207750|147399376|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for PT antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PT antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
73972657|NCT05256654|147487159|SUPERIORITY||Mean Difference (Net)|-19.7|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-27.2|-11.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-11.3|-27.2|<.001
73957836|NCT03068468|147451202|SUPERIORITY||Difference|0.0||||0.9864|TWO_SIDED|95.0|-0.039|0.04|||MMRM|||Pons Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.040|-0.039|0.9864
73935092|NCT03207750|147399376|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for FHA antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV lyophilized group||To rule out 10% decrease in seroresponse to FHA antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
73866086|NCT01178099|147278356|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||This is the p-value for AU\*min to TRAP-6. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.086
73935093|NCT03207750|147399376|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for PRN antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PRN antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
73935094|NCT03321019|147399395|OTHER||F-statistic|8.59|||<|0.0001|TWO_SIDED|||||The p value was adjusted for multiple comparisons using Tukey's method.|ANOVA|Degree of freedom - 3, 278||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||<.0001
73935095|NCT03321019|147399396|OTHER||F-statistic|0.44||||0.72|TWO_SIDED|||||Tukey's method was used to control for multiple comparisons.|ANOVA|Degrees of freedom - 3. 278||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.72
73935096|NCT03321019|147399397|OTHER||F-statistic|3.048||||0.02|TWO_SIDED|||||Dunnett's T3 method was used to account for multiple comparisons.|ANOVA|degrees of freedom: 3, 229||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.02
73935097|NCT03321019|147399398|OTHER||F-statistic|2.939||||0.034|TWO_SIDED|||||The p value was adjusted in the analysis for multiple comparisons using Tukey's method.|ANOVA|Degrees of freedom - 3, 231||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.034
73935098|NCT03321019|147399399|OTHER||F-statistic|1.494||||0.022|TWO_SIDED|||||Tukey's method was used to adjust for multiple comparisons.|ANOVA|Degrees of freedom - 3, 274||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.022
73935099|NCT02752048|147399434|OTHER|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-1.378||||0.596|TWO_SIDED|95.0|-6.757|4.0|||t-test, 2 sided|||||4.000|-6.757|0.596
73935100|NCT02752048|147399434|OTHER|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|1.349||||0.433|TWO_SIDED|95.0|-2.22|4.918|||t-test, 2 sided|||||4.918|-2.220|0.433
73972658|NCT05256654|147487159|SUPERIORITY||Mean Difference (Net)|-19.4|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-27.0|-11.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-11.0|-27.0|<.001
73866087|NCT01178099|147278357|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.083
73935101|NCT02752048|147399435|OTHER|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.484||||0.382|TWO_SIDED|95.0|-1.618|0.65|||t-test, 2 sided|||||0.650|-1.618|0.382
73935102|NCT02752048|147399435|OTHER|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.397||||0.501|TWO_SIDED|95.0|-1.61|0.817|||t-test, 2 sided|||||0.817|-1.610|0.501
73935103|NCT02752048|147399436|OTHER|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.533||||0.549|TWO_SIDED|95.0|-2.363|1.298|||t-test, 2 sided|||||1.298|-2.363|0.549
73935104|NCT02752048|147399436|OTHER|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.225||||0.767|TWO_SIDED|95.0|-1.801|1.351|||t-test, 2 sided|||||1.351|-1.801|0.767
73935105|NCT01312467|147399437|SUPERIORITY_OR_OTHER||||||>|0.773|TWO_SIDED||||||A paired t-test|||||||> 0.773
73935106|NCT00132769|147399441|SUPERIORITY_OR_OTHER||Difference in LS Mean|1.48||||0.278|TWO_SIDED|95.0|-1.21|4.18|||ANCOVA|||||4.18|-1.21|0.278
73935107|NCT00132769|147399442|SUPERIORITY_OR_OTHER||Difference in Percent|-5.66||||0.543|TWO_SIDED|95.0|-24.45|13.13|||Cochran-Mantel-Haenszel|||||13.13|-24.45|0.543
73935108|NCT00132769|147399449|SUPERIORITY_OR_OTHER||LS mean ratio between treatments|0.84||||0.225|TWO_SIDED|95.0|0.63|1.12|||ANCOVA|||||1.12|0.63|0.225
73935109|NCT02670629|147399501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
73935110|NCT01344460|147399509|SUPERIORITY_OR_OTHER||Percentage difference|18.3|||<|0|TWO_SIDED|95.0|15.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||15.2|<0.000
73935111|NCT01344460|147399509|SUPERIORITY_OR_OTHER||Percentage difference|16.4|||<|0|TWO_SIDED|95.0|13.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||13.2|<0.000
73935112|NCT01344460|147399509|SUPERIORITY_OR_OTHER||Percentage difference|24.0|||<|0|TWO_SIDED|95.0|20.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||20.5|<0.000
73935113|NCT01344460|147399509|SUPERIORITY_OR_OTHER||Percentage difference|17.4|||<|0|TWO_SIDED|95.0|14.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||14.3|<0.000
73935114|NCT01344460|147399509|SUPERIORITY_OR_OTHER||Percentage difference|25.6|||<|0|TWO_SIDED|95.0|21.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||21.9|<0.000
73935115|NCT01344460|147399510|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|6.8|||||TWO_SIDED|95.0|-2.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-2.2|
73935116|NCT01344460|147399510|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|0.0|||||TWO_SIDED|95.0|-9.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-9.7|
73935117|NCT01344460|147399510|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|14.3|||||TWO_SIDED|95.0|5.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||5.1|
74039409|NCT04847141|147632412|SUPERIORITY||LS Mean Difference|0.03||||0.8108|TWO_SIDED|95.0|-0.22|0.28|||ANCOVA||95% CI for difference in LSM between 2 g C19-IG 20% \& placebo was calculated using an ANCOVA model,with number of days on oxygen as dependent variable \& treatment group as fixed effect,adjusting for baseline characteristics(including age \& gender).|||0.28|-0.22|0.8108
73935118|NCT01344460|147399510|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|3.0|||||TWO_SIDED|95.0|-5.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.8|
73935119|NCT01344460|147399510|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|20.0|||||TWO_SIDED|95.0|11.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.7|
73935120|NCT01344460|147399511|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.0|||||TWO_SIDED|95.0|7.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.0|
73935121|NCT01344460|147399511|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|11.3|||||TWO_SIDED|95.0|9.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||9.1|
73935122|NCT01344460|147399511|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||TWO_SIDED|95.0|7.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.6|
73935123|NCT01344460|147399511|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|13.4|||||TWO_SIDED|95.0|11.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.2|
73935124|NCT01344460|147399511|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|13.1|||||TWO_SIDED|95.0|11.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.0|
73935125|NCT01344460|147399512|SUPERIORITY_OR_OTHER||percentage|54.6|||||ONE_SIDED|95.0|46.2||||One sided 95% confidence interval|||Majority reader|||46.2|
73935126|NCT01344460|147399512|SUPERIORITY_OR_OTHER||percentage|51.6|||||ONE_SIDED|95.0|43.6||||One sided 95% confidence interval|||Blinded Reader 1|||43.6|
73935127|NCT01344460|147399512|SUPERIORITY_OR_OTHER||percentage|54.4|||||ONE_SIDED|95.0|45.5||||One sided 95% confidence interval|||Blinded Reader 2|||45.5|
73935128|NCT01344460|147399512|SUPERIORITY_OR_OTHER||percentage|53.4|||||ONE_SIDED|95.0|44.8||||One sided 95% confidence interval|||Blinded Reader 3|||44.8|
73935129|NCT01344460|147399512|SUPERIORITY_OR_OTHER||percentage|71.3|||||ONE_SIDED|95.0|64.7||||One sided 95% confidence interval|||Clinical investigator|||64.7|
73935130|NCT01344460|147399513|SUPERIORITY_OR_OTHER||percentage|95.9|||||ONE_SIDED|95.0|94.9||||One sided 95% confidence interval|||Majority reader|||94.9|
73935131|NCT01344460|147399513|SUPERIORITY_OR_OTHER||percentage|95.0|||||ONE_SIDED|95.0|93.8||||One sided 95% confidence interval|||Blinded Reader 1|||93.8|
73935132|NCT01344460|147399513|SUPERIORITY_OR_OTHER||percentage|96.2|||||ONE_SIDED|95.0|95.2||||One sided 95% confidence interval|||Blinded Reader 2|||95.2|
73935133|NCT01344460|147399513|SUPERIORITY_OR_OTHER||percentage|95.8|||||ONE_SIDED|95.0|94.8||||One sided 95% confidence interval|||Blinded Reader 3|||94.8|
73935134|NCT01344460|147399513|SUPERIORITY_OR_OTHER||percentage|98.4|||||ONE_SIDED|95.0|97.8||||One sided 95% confidence interval|||Clinical investigator|||97.8|
73935135|NCT01344460|147399516|SUPERIORITY_OR_OTHER||Diameter difference|0.17|STANDARD_DEVIATION|1.28|||||||||Mean Difference|||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point||||
73935136|NCT01344460|147399516|SUPERIORITY_OR_OTHER||Diameter difference|-0.09|STANDARD_DEVIATION|1.14|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point||||
73935137|NCT01344460|147399516|SUPERIORITY_OR_OTHER||Mean Difference|0.41|STANDARD_DEVIATION|1.15|||||||||Mean Difference|||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point||||
73935138|NCT01344460|147399516|SUPERIORITY_OR_OTHER||Diameter difference|-0.15|STANDARD_DEVIATION|1.01|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point||||
73935139|NCT00560833|147399531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.01|TWO_SIDED|95.0|-2.3|-0.4||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.4|-2.3|<0.01
73935140|NCT00560833|147399531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.01|TWO_SIDED|95.0|-3.1|-1.2||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.2|-3.1|<0.01
73935141|NCT00560833|147399531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.0|-2.9|<0.01
73935142|NCT00560833|147399531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.0|-2.9|<0.01
73935143|NCT00560833|147399533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.06|TWO_SIDED|95.0|-2.0|0.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.0|-2.0|0.06
73935144|NCT00560833|147399533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|||<|0.01|TWO_SIDED|95.0|-3.0|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.9|-3.0|<0.01
73935145|NCT00560833|147399533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.9|-2.9|<0.01
73935146|NCT00560833|147399533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.01|TWO_SIDED|95.0|-2.6|-0.5||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.5|-2.6|<0.01
73935147|NCT00560833|147399534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.62|TWO_SIDED|95.0|-0.09|0.03||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.03|-0.09|0.62
73935148|NCT00560833|147399534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.02|TWO_SIDED|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.12|0.02
73935149|NCT00560833|147399534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.01|TWO_SIDED|95.0|-0.13|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.13|0.01
73935150|NCT00560833|147399534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.02|TWO_SIDED|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.12|0.02
73935151|NCT00560833|147399535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||1|TWO_SIDED|95.0|-0.06|0.07||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.07|-0.06|1.0
73935152|NCT00560833|147399535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.72|TWO_SIDED|95.0|-0.09|0.04||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.04|-0.09|0.72
73935153|NCT00560833|147399535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.13|TWO_SIDED|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.01|-0.12|0.13
73935154|NCT00560833|147399535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.15|TWO_SIDED|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.01|-0.12|0.15
73935155|NCT01085318|147399536|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|864.1||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
73935156|NCT01085318|147399537|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|644.99|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935157|NCT02199691|147399545|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|9.2|||||TWO_SIDED|95.0|3.4|15.0||||||Serogroup A||15|3.4|
73935158|NCT02199691|147399545|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|24.6|||||TWO_SIDED|95.0|20.3|29.0||||||Serogroup C||29|20.3|
73935159|NCT02199691|147399545|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|16.2|||||TWO_SIDED|95.0|12.3|20.2||||||||20.2|12.3|
73935160|NCT02199691|147399545|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|19.6|||||TWO_SIDED|95.0|14.2|24.8||||||Serogroup W||24.8|14.2|
73935161|NCT02199691|147399546|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|5.0|||||TWO_SIDED|95.0|-0.8|10.5||||||Serogroup A||10.5|-0.8|
73972659|NCT05256654|147487160|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|4.16||0.428|TWO_SIDED|95.0|-11.2|5.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||5.2|-11.2|0.428
73972660|NCT05256654|147487160|SUPERIORITY||Mean Difference (Net)|-8.7|STANDARD_ERROR_OF_MEAN|3.14||0.009|TWO_SIDED|95.0|-14.7|-2.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-2.3|-14.7|0.009
74088861|NCT00680186|147730895|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.13||||0.0002||95.0|0.69|1.85||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the risk difference (RD) (at day 180) and for the HR (up to end of ptp) analyses to be reached in order to conclude positively on primary endpoint|Regression, Cox|Patients without events are censored at the end of ptp.||Hazard ratio (HR) vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.85|0.69|0.0002
74091657|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.23|||<|0.001|TWO_SIDED|95.0|0.99|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 7F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|0.99|<0.001
73866088|NCT01178099|147278358|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.124
73935162|NCT02199691|147399546|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.5|2.4||||||Serogroup C||2.4|-2.5|
73935163|NCT02199691|147399546|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-4.3|1.2||||||Serogroup Y||1.2|-4.3|
73935164|NCT02199691|147399546|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-7.3|2.6||||||Serogroup W||2.6|-7.3|
73935165|NCT02199691|147399547|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.845|||||TWO_SIDED|95.0|0.722|0.99||||||PT: Geometric Mean Ratio||0.99|0.722|
73972661|NCT05256654|147487160|SUPERIORITY||Mean Difference (Net)|-12.2|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-18.0|-6.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-6.0|-18.0|<.001
73972662|NCT05256654|147487161|SUPERIORITY||Mean Difference (Net)|6.5|STANDARD_ERROR_OF_MEAN|8.1||0.412|TWO_SIDED|95.0|-8.4|23.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||23.7|-8.4|0.412
73972663|NCT05256654|147487161|SUPERIORITY||Mean Difference (Net)|-9.5|STANDARD_ERROR_OF_MEAN|5.52||0.104|TWO_SIDED|95.0|-19.7|2.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.1|-19.7|0.104
73972664|NCT05256654|147487161|SUPERIORITY||Mean Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|5.79||0.363|TWO_SIDED|95.0|-16.2|6.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||6.7|-16.2|0.363
73972665|NCT05256654|147487162|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|6.19||0.101|TWO_SIDED|95.0|-22.2|2.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.3|-22.2|0.101
73935166|NCT02199691|147399547|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.746|||||TWO_SIDED|95.0|0.661|0.842||||||FHA: Geometric Mean Ratio||0.842|0.661|
73935167|NCT02199691|147399547|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.753|||||TWO_SIDED|95.0|0.627|0.903||||||PRN: Geometric Mean Ratio||0.903|0.627|
73935168|NCT02199691|147399547|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.679|||||TWO_SIDED|95.0|0.525|0.878||||||FIM: Geometric Mean Ratio||0.878|0.525|
73935169|NCT02199691|147399548|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|-1.1|||||TWO_SIDED|95.0|-3.3|1.3||||||Serogroup Diphtheria||1.3|-3.3|
73972666|NCT05256654|147487162|SUPERIORITY||Mean Difference (Net)|-11.3|STANDARD_ERROR_OF_MEAN|4.96||0.033|TWO_SIDED|95.0|-20.6|-1.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-1.0|-20.6|0.033
73935170|NCT02199691|147399548|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.1|||||TWO_SIDED|95.0|-1.2|1.9||||||Serogroup Tetanus||1.9|-1.2|
73935171|NCT02199691|147399549|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-1.8|6.3||||||HPV Type 6||6.3|-1.8|
73935172|NCT02199691|147399549|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.8|||||TWO_SIDED|95.0|-1.3|3.9||||||HPV Type 11||3.9|-1.3|
73935173|NCT02199691|147399549|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.4|||||TWO_SIDED|95.0|-1.9|3.6||||||HPV Type 16||3.6|-1.9|
73935174|NCT02199691|147399549|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.4|||||TWO_SIDED|95.0|-1.9|3.6||||||HPV Type 18||3.6|-1.9|
73935175|NCT01404312|147399598|NON_INFERIORITY|"Non-inferiority margin: 1.25 events per 100 person-years.~Sample size determination was based on the assumption of a primary endpoint rate of 2.0/100 person-years, with a one-sided 0.025 alpha level, and targeting at least 90% power. This required a sample size of approximately 2500. The sample size was adjusted upwards to account for loss to follow-up, interim monitoring, and to allow for subgroup analyses with reasonable power."|Incidence Rate Difference|-0.0231|||||TWO_SIDED|95.1|-0.346|0.3|||||"Estimate given as Incidence rate in Arm A - Incidence Rate in Arm B (negative favors Arm A).~Incidence rate units: Events per 100 person-years"|Mantel-Haenszel method used for estimating standardized incidence rate in each arm and incidence rate difference.||0.300|-0.346|
73935176|NCT01404312|147399599|SUPERIORITY||Risk Difference (RD)|-0.016||||0.073|TWO_SIDED|95.0|-0.035|0.002||Not adjusted for multiple comparisons.|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any SAE occurrence between arms A and B.~H0: Proportion of participants with SAE in Arm A = Proportion of participants with SAE in Arm B."||0.002|-0.035|0.073
73935177|NCT01404312|147399600|SUPERIORITY||Risk Difference (RD)|-0.0058||||0.405|TWO_SIDED|95.0|-0.019|0.007||Not adjusted for multiple comparisons|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any targeted adverse event occurrence between arms A and B.~H0: Proportion of participants with a targeted adverse event in Arm A = Proportion of participants with a targeted adverse event in Arm B."||0.007|-0.019|0.405
73935178|NCT01404312|147399601|SUPERIORITY||Odds Ratio (OR)|2.093|||||TWO_SIDED|95.0|1.315|3.332|||||"Estimate given as: Odds of being in higher category (more stringent management due to toxicity) for Arm B compared with arm A~Not adjusted for multiple comparisons."|"Odds ratio of being in higher category estimated from proportional odds model~H0: Odds ratio of being in higher category for Arm A vs Arm B = 1"||3.332|1.315|
73935179|NCT01404312|147399602|SUPERIORITY|||||||0.3078||||||Not adjusted for multiple comparisons|Log Rank|||H0: Survival curve Arm A = Survival curve Arm B||||0.3078
73866089|NCT02516592|147278362|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.028|TWO_SIDED|95.0|0.005|0.084|||Mixed Models Analysis|||||0.084|0.005|0.028
73866090|NCT02516592|147278363|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.063|TWO_SIDED|95.0|-0.03|0.94|||Mixed Models Analysis|||||0.94|-0.03|0.063
73935180|NCT01404312|147399603|SUPERIORITY||Hazard Ratio (HR)|1.396||||0.2802|TWO_SIDED|95.0|0.762|2.559||Not adjusted for multiple comparisons|Hazard Ratio||Hazard ratio given as: Arm B hazard / Arm A hazard, i.e. HR \> 1 favors arm A|"Competing risk analysis using the Fine-Gray model, treating TB-related deaths as competing risks, and other deaths including deaths of unknown cause as the event of interest.~H0: Hazard Ratio for Arm A vs Arm B = 1"||2.559|0.762|0.2802
73935181|NCT04419493|147399609|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%|Geometric Least Squares Mean ratio (%)|102.2|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|92.83|94.87|110.1|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||110.10|94.87|
73935182|NCT04419493|147399611|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%|Geometric Least Squares Mean ratio (%)|105.81|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|92.83|99.18|112.88|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||112.88|99.18|
73957837|NCT03068468|147451202|SUPERIORITY||Difference|0.001||||0.7529|TWO_SIDED|95.0|-0.004|0.006|||MMRM|||Cerebellar Peduncle Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.006|-0.004|0.7529
73935183|NCT04419493|147399613|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00% .|Geometric Least Squares Mean ratio (%)|102.17|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|92.83|94.79|110.12|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||110.12|94.79|
74030457|NCT02078713|147615164|SUPERIORITY||Odds Ratio (OR)|1.27||||0.18|TWO_SIDED|95.0|0.9|1.81||P-value calculated from multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|"The odds ratio represents the odds of the intervention group rating their appointment as much better, in the numerator, over the odds of the control group giving this rating in the denominator."|Patients excluded from test if they reported not having had a previous contraceptive counseling appointment.||1.81|0.90|0.18
73935184|NCT03119766|147399618|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.041|TWO_SIDED|95.0|0.04|1.85|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of GIS scores after 8 weeks of treatment were compared.||1.85|0.04|0.041
73935185|NCT03119766|147399618|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.041|TWO_SIDED|95.0|0.04|1.74|||Mixed Models Analysis||"Fixed factor Treatment and random factor research center were used in mixed model. Difference in mean changes between groups was estimeted."|Mean changes of GIS scores after 8 weeks of treatment were compared. Influence of between center variation was estimated.||1.74|0.04|0.041
73935186|NCT03119766|147399619|SUPERIORITY|||||||0.067|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 1 point.||||0.067
73935187|NCT03119766|147399619|SUPERIORITY|||||||0.029|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 2 points.||||0.029
73935188|NCT03119766|147399619|SUPERIORITY|||||||0.082|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 3 points.||||0.082
73935189|NCT03119766|147399619|SUPERIORITY|||||||0.046|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 4 points.||||0.046
74030458|NCT02078713|147615165|SUPERIORITY||Mean Difference (Final Values)|11.81|||<|0.001|TWO_SIDED|95.0|8.54|18.66||P-value calculated in multiple imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.|||18.66|8.54|<0.001
73866091|NCT02516592|147278364|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.002|TWO_SIDED|95.0|0.037|0.167|||Mixed Models Analysis|||||0.167|0.037|0.002
73866092|NCT02516592|147278365|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.319|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||||0.4|-1.3|0.319
73935190|NCT03119766|147399619|SUPERIORITY|||||||0.111|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 5 points.||||0.111
73935191|NCT03119766|147399620|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.435|TWO_SIDED|95.0|-0.93|2.15|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of NDI scores after 8 weeks of treatment were compared.||2.15|-0.93|0.435
73935192|NCT03119766|147399621|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.655|TWO_SIDED|95.0|-2.0|1.26|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of SF-36 scores (physical health domain) after 8 weeks of treatment were compared.||1.26|-2.00|0.655
73935193|NCT03119766|147399621|SUPERIORITY||Median Difference (Final Values)|0.65||||0.375|TWO_SIDED|95.0|-0.79|2.1|||ANOVA|||Mean changes of SF-36 scores (mental health domain) after 8 weeks of treatment were compared.||2.10|-0.79|0.375
73935194|NCT03119766|147399622|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73935195|NCT03119766|147399623|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Side effects analysis.||||0.08
73935196|NCT03119766|147399623|SUPERIORITY|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect||||0.139
73935197|NCT03119766|147399623|SUPERIORITY|||||||0.251|||||||Wilcoxon (Mann-Whitney)|||Efficacy index analysis.||||0.251
73935198|NCT01073618|147399624|SUPERIORITY_OR_OTHER||Efficacy rate (percent)|75.15|||||TWO_SIDED|95.0|71.36|78.94|||Normal approximation to binomial||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement||78.94|71.36|
73935199|NCT00982020|147399626|SUPERIORITY_OR_OTHER|||||||0.15||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures analysis terms included baseline BMI, baseline age, gender, intervention group, visit, region, intervention group\*visit.||||||0.150
73935200|NCT00982020|147399627|SUPERIORITY_OR_OTHER|||||||0.52||||||The threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model terms included: baseline, baseline age, gender, intervention group, and region.||||||0.520
73935201|NCT00982020|147399629|SUPERIORITY_OR_OTHER|||||||0.008||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.008
73935202|NCT00982020|147399630|SUPERIORITY_OR_OTHER|||||||0.266||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included intervention group, visit, region, and intervention group\*visit.||||||0.266
74030459|NCT02078713|147615166|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.63|TWO_SIDED|95.0|-3.19|5.29||P-value calculated in multiply imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.|||5.29|-3.19|0.63
73935203|NCT00982020|147399631|SUPERIORITY_OR_OTHER|||||||0.954||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM analysis terms included baseline, baseline age, gender, intervention group, visit, region, and intervention group\*visit.||||||0.954
73935204|NCT00982020|147399632|SUPERIORITY_OR_OTHER|||||||0.103||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.103
73935205|NCT00982020|147399633|SUPERIORITY_OR_OTHER|||||||0.436||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.436
73935206|NCT00466193|147399638|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for treatment|ANCOVA|||||||<0.001
73935207|NCT00466193|147399640|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for treatment|ANCOVA|||||||0.006
73935208|NCT00466193|147399643|SUPERIORITY_OR_OTHER|||||||0.0041||95.0||||P-value is for treatment|ANCOVA|||||||0.0041
73935209|NCT04088097|147399682|SUPERIORITY|||||||0.01|||||||ANOVA|||||||.01
73935210|NCT04088097|147399683|SUPERIORITY|||||||0.75|||||||ANOVA|||||||.75
73935211|NCT04088097|147399684|SUPERIORITY|||||||0.03|||||||ANOVA|||||||.03
73972667|NCT05256654|147487162|SUPERIORITY||Mean Difference (Net)|-10.9|STANDARD_ERROR_OF_MEAN|4.98||0.04|TWO_SIDED|95.0|-20.3|-0.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-0.6|-20.3|0.040
73972668|NCT05256654|147487163|SUPERIORITY||Mean Difference (Net)|-28.3|STANDARD_ERROR_OF_MEAN|6.79|<|0.001|TWO_SIDED|95.0|-40.5|-13.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-13.6|-40.5|<.001
73935212|NCT01854554|147399713|SUPERIORITY|||||||0.74|||||||Gray's test|Cumulative Incidence Function treating progressive disease (RANO) or death before cognitive function decline as a competing risk.||||||.74
73935213|NCT01854554|147399714|SUPERIORITY|||||||0.6|||||||Log Rank|||||||.60
73935214|NCT01854554|147399715|SUPERIORITY|||||||0.24|||||||Log Rank|||||||0.24
73935215|NCT02819726|147399717|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|95.33|||||TWO_SIDED|90.0|87.07|104.37||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment||104.37|87.07|
73935216|NCT02819726|147399717|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|93.43|||||TWO_SIDED|90.0|85.54|102.15||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.15|85.54|
73935217|NCT02819726|147399717|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.06|||||TWO_SIDED|90.0|89.49|107.45||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment||107.45|89.49|
73935218|NCT02819726|147399718|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.07|||||TWO_SIDED|90.0|86.91|101.81||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||101.81|86.91|
73972669|NCT05256654|147487163|SUPERIORITY||Mean Difference (Net)|-42.5|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-50.5|-33.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-33.2|-50.5|<.001
74030460|NCT02078713|147615167|SUPERIORITY||Observed coefficient|-3.97|STANDARD_ERROR_OF_MEAN|3.34||0.24|TWO_SIDED|95.0|-10.62|2.68|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error.|Test of follow-up score of emotional exhaustion subscale of Maslach Burnout Inventory, controlling for baseline score and site||2.68|-10.62|0.24
73866093|NCT02516592|147278366|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.662|TWO_SIDED|95.0|-0.2|0.13|||Mixed Models Analysis|||||0.13|-0.20|0.662
73935219|NCT02819726|147399718|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|94.39|||||TWO_SIDED|90.0|87.21|102.16||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.16|87.21|
73935220|NCT02819726|147399718|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|100.35|||||TWO_SIDED|90.0|92.68|108.65||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||108.65|92.68|
73935221|NCT02819726|147399719|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|96.31|||||TWO_SIDED|90.0|90.52|102.46||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.46|90.52|
73935222|NCT02819726|147399719|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.65|||||TWO_SIDED|90.0|92.64|105.05||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||105.05|92.64|
73935223|NCT02819726|147399719|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.43|||||TWO_SIDED|90.0|96.14|109.14||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||109.14|96.14|
73935224|NCT02819726|147399720|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.93|||||TWO_SIDED|90.0|89.03|101.23||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||101.23|89.03|
73935225|NCT02819726|147399720|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.75|||||TWO_SIDED|90.0|92.61|105.3||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||105.30|92.61|
74030461|NCT02078713|147615167|SUPERIORITY||Observed coefficient|-1.52|STANDARD_ERROR_OF_MEAN|1.91||0.36|TWO_SIDED|95.0|-4.76|1.72|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error|Linear regression of follow-up score for depersonalization subscale of Maslach Burnout Inventory, controlling for baseline score and site.||1.72|-4.76|0.36
74030462|NCT02078713|147615167|SUPERIORITY||Slope|-1.64|STANDARD_ERROR_OF_MEAN|1.34||0.28|TWO_SIDED|95.0|-4.61|1.34|||Regression, Linear||Tool group compared to control group (ref). Bootstrapping used for standard error.|Linear regression of follow-up score for personal accomplishment subscale of Maslach Burnout Inventory, controlling for site and baseline score.||1.34|-4.61|0.28
73935226|NCT02819726|147399720|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|104.03|||||TWO_SIDED|90.0|97.54|110.95||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||110.95|97.54|
73935227|NCT02819726|147399721|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|89.08|||||TWO_SIDED|90.0|77.2|102.79||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.79|77.20|
73935228|NCT02819726|147399721|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.56|||||TWO_SIDED|90.0|88.72|118.56||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||118.56|88.72|
73935229|NCT02819726|147399721|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|115.13|||||TWO_SIDED|90.0|99.51|133.21||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||133.21|99.51|
73935230|NCT02819726|147399722|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.134||0.2402|TWO_SIDED|95.0|-0.422|0.106|||ANCOVA|||Least square means and confidence intervals (CIs) were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.106|-0.422|0.2402
73935231|NCT02819726|147399722|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Means Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.135||0.1346|TWO_SIDED|95.0|-0.469|0.063|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.063|-0.469|0.1346
73935232|NCT02819726|147399722|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Means Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.137||0.7429|TWO_SIDED|95.0|-0.314|0.224|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.224|-0.314|0.7429
73935233|NCT02819726|147399731|OTHER||LS Means Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.172||0.6068|TWO_SIDED|95.0|-0.428|0.25|||ANCOVA|||Week 52 (EOS). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.250|-0.428|0.6068
73935234|NCT02819726|147399731|OTHER||LS Means Difference|0.09|STANDARD_ERROR_OF_MEAN|0.172||0.599|TWO_SIDED|95.0|-0.249|0.43|||ANCOVA|||Week 52 (EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.430|-0.249|0.5990
73935235|NCT02819726|147399731|OTHER||LS Means Difference|0.18|STANDARD_ERROR_OF_MEAN|0.175||0.3053|TWO_SIDED|95.0|-0.165|0.532|||ANCOVA|||Week 53 (EOS) MabThera vs Rituxan. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.532|-0.165|0.3053
73935236|NCT02819726|147399732|OTHER||Difference (%)|9.4|STANDARD_ERROR_OF_MEAN|7.22|||TWO_SIDED|95.0|-4.74|23.03||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||23.03|-4.74|
73935237|NCT02819726|147399732|OTHER||Difference (%)|-2.5|STANDARD_ERROR_OF_MEAN|7.05|||TWO_SIDED|95.0|-15.95|11.22||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||11.22|-15.95|
73935238|NCT02819726|147399732|OTHER||Difference (%)|-11.8|STANDARD_ERROR_OF_MEAN|7.26|||TWO_SIDED|95.0|-25.47|2.45||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||2.45|-25.47|
74030463|NCT02078713|147615168|SUPERIORITY||Odds Ratio (OR)|1.06||||0.78|TWO_SIDED|95.0|0.69|1.65||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.65|0.69|0.78
73866094|NCT02473367|147278367|SUPERIORITY_OR_OTHER||Geom. least-squares mean ratio (GLSMR)|0.28|||||TWO_SIDED|90.0|0.24|0.32|||||Raltegravir+TUMS/Raltegravir only|||0.32|0.24|
73866095|NCT02473367|147278367|SUPERIORITY_OR_OTHER||GLSMR|0.86|||||TWO_SIDED|90.0|0.73|1.03|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||1.03|0.73|
73866096|NCT02473367|147278367|SUPERIORITY_OR_OTHER||GLSMR|0.9|||||TWO_SIDED|90.0|0.8|1.03|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||1.03|0.80|
74030464|NCT02078713|147615169|SUPERIORITY||Odds Ratio (OR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.35|0.66|0.75
74030465|NCT02078713|147615169|SUPERIORITY||Odds Ratio (OR)|1.07||||0.71|TWO_SIDED|95.0|0.75|1.53||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.53|0.75|0.71
74088862|NCT00680186|147730895|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 3.6% for the RD based on KM estimates|Risk Difference (Percentage)|0.2|||<|0.0001||95.0|-1.0|1.3||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the RD (at day 180) and for the HR (events up to end of ptp) analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.3|-1.0|<0.0001
73935239|NCT02819726|147399733|OTHER||Difference (%)|9.5|STANDARD_ERROR_OF_MEAN|6.87|||TWO_SIDED|95.0|-4.07|22.46||||||ACR20 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||22.46|-4.07|
73935240|NCT02819726|147399733|OTHER||Difference (%)|3.5|STANDARD_ERROR_OF_MEAN|7.07|||TWO_SIDED|95.0|-10.22|17.03||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||17.03|-10.22|
73935241|NCT02819726|147399733|OTHER||Difference (%)|-5.9|STANDARD_ERROR_OF_MEAN|6.88|||TWO_SIDED|95.0|-19.1|7.51||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||7.51|-19.10|
73935242|NCT02819726|147399733|OTHER||Difference (%)|10.0|STANDARD_ERROR_OF_MEAN|5.78|||TWO_SIDED|95.0|-1.52|21.22||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||21.22|-1.52|
73935243|NCT02819726|147399733|OTHER||Difference|5.4|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-6.69|17.13||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||17.13|-6.69|
73935244|NCT02819726|147399733|OTHER||Difference (%)|-4.7|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|92.0|-15.68|6.41||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||6.41|-15.68|
73935245|NCT02819726|147399734|OTHER||LS Means Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.991||0.1997|TWO_SIDED|95.0|-3.23|0.671|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||0.671|-3.230|0.1997
73935246|NCT02819726|147399734|OTHER||LS Means Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.996||0.9098|TWO_SIDED|95.0|-2.074|1.848|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||1.848|-2.074|0.9098
73935247|NCT02819726|147399734|OTHER||LS Means Difference|1.17|STANDARD_ERROR_OF_MEAN|1.008||0.248|TWO_SIDED|95.0|-0.817|3.15|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||3.150|-0.817|0.2480
73935248|NCT02819726|147399734|OTHER||LS Means Difference|-1.96|STANDARD_ERROR_OF_MEAN|1.5||0.1931|TWO_SIDED|95.0|-4.909|0.996|||ANCOVA|||Tender Joint Count (TJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||0.996|-4.909|0.1931
73935249|NCT02819726|147399734|OTHER||LS Means Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.5||-0.77|TWO_SIDED|95.0|-3.722|2.184|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||2.184|-3.722|-0.77
73935250|NCT02819726|147399734|OTHER||LS Means Difference|1.19|STANDARD_ERROR_OF_MEAN|1.52||0.4352|TWO_SIDED|95.0|-1.805|4.18|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||4.180|-1.805|0.4352
74030466|NCT02078713|147615170|SUPERIORITY||Odds Ratio (OR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.34||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.34|0.66|0.75
73935251|NCT02819726|147399735|OTHER||LS Means Difference|-4.16|STANDARD_ERROR_OF_MEAN|3.242||0.2008|TWO_SIDED|95.0|-10.541|2.226|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||2.226|-10.541|0.2008
73935252|NCT02819726|147399735|OTHER||LS Means Difference|-0.39|STANDARD_ERROR_OF_MEAN|3.242||-0.39|TWO_SIDED|95.0|-6.771|5.994|||ANOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline||5.994|-6.771|-0.39
73935253|NCT02819726|147399735|OTHER||LS Means Difference|3.77|STANDARD_ERROR_OF_MEAN|3.268||0.2498|TWO_SIDED|95.0|-2.665|10.204|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline||10.204|-2.665|0.2498
73935254|NCT02819726|147399736|OTHER||LS Means Difference|-1.23|STANDARD_ERROR_OF_MEAN|3.592||0.7322|TWO_SIDED|95.0|-8.0302|5.841|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.841|-8.0302|0.7322
73935255|NCT02819726|147399736|OTHER||LS Means Difference|-2.21|STANDARD_ERROR_OF_MEAN|3.623||0.5418|TWO_SIDED|95.0|-9.347|4.92|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||4.920|-9.347|0.5418
73935256|NCT02819726|147399736|OTHER||LS Means Difference|-0.98|STANDARD_ERROR_OF_MEAN|3.633||0.7869|TWO_SIDED|95.0|-8.136|6.169|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||6.169|-8.136|0.7869
73935257|NCT02819726|147399737|OTHER||LS Means Difference|-1.28|STANDARD_ERROR_OF_MEAN|3.443||0.7097|TWO_SIDED|95.0|-8.062|5.496|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||5.496|-8.062|0.7097
73935258|NCT02819726|147399737|OTHER||LS Means Difference|-1.48|STANDARD_ERROR_OF_MEAN|3.453||0.6683|TWO_SIDED|95.0|-8.28|5.317|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||5.317|-8.280|0.6683
73935259|NCT02819726|147399737|OTHER||LS Means Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.494||0.9548|TWO_SIDED|95.0|-7.078|6.682|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||6.682|-7.078|0.9548
73935260|NCT02819726|147399738|OTHER||LS Means Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.086||0.0505|TWO_SIDED|95.0|-0.339|0.0|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.000|-0.339|0.0505
73935261|NCT02819726|147399738|OTHER||LS Means Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.086||0.1141|TWO_SIDED|95.0|-0.307|0.033|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.033|-0.307|0.1141
73972670|NCT05256654|147487163|SUPERIORITY||Mean Difference (Net)|-44.8|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-52.5|-35.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-35.9|-52.5|<.001
74030467|NCT02078713|147615170|SUPERIORITY||Odds Ratio (OR)|1.17||||0.37|TWO_SIDED|95.0|0.83|1.64||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.64|0.83|0.37
74030468|NCT02078713|147615171|SUPERIORITY||Odds Ratio (OR)|1.27||||0.63|TWO_SIDED|95.0|0.48|3.37||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||3.37|0.48|0.63
73935262|NCT02819726|147399738|OTHER||LS Means Difference|0.03|STANDARD_ERROR_OF_MEAN|0.087||0.7111|TWO_SIDED|95.0|-0.139|0.204|||ANCOVA|||Week 52 (EOS) HAQ-DI )0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.204|-0.139|0.7111
73935263|NCT02819726|147399739|OTHER||LS Means Difference|-0.43|STANDARD_ERROR_OF_MEAN|1.871||0.8183|TWO_SIDED|95.0|-4.113|3.253|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||3.253|-4.113|0.8183
73935264|NCT02819726|147399739|OTHER||LS Means Difference|1.51|STANDARD_ERROR_OF_MEAN|1.868||0.4186|TWO_SIDED|95.0|-2.164|5.191|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.191|-2.164|0.4186
73972671|NCT02567409|147487197|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.69|1.98|||||Hazard ratio relative to arm B.|||1.98|0.69|
73972672|NCT02567409|147487198|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.71|2.48|||||Hazard ratio relative to arm B.|||2.48|0.71|
73972673|NCT02567409|147487199|SUPERIORITY|||||||0.51|||||||Fisher Exact|||||||0.51
73972674|NCT03505008|147487241|NON_INFERIORITY|Two-sided 90% CI for the intergroup difference in SDAI remission rates to exceed the non-inferiority margin of -15%|Risk Difference (RD)|0.0|||||TWO_SIDED|90.0||||||||||||
73866097|NCT02473367|147278368|SUPERIORITY_OR_OTHER||GLSMR|0.26|||||TWO_SIDED|90.0|0.21|0.32|||||Raltegravir+TUMS/Raltegravir only|||0.32|0.21|
73935265|NCT02819726|147399739|OTHER||LS Means Difference|1.94|STANDARD_ERROR_OF_MEAN|1.885||0.3035|TWO_SIDED|95.0|-1.768|5.655|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.655|-1.768|0.3035
73935266|NCT02819726|147399740|OTHER||LS Means Difference|0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9249|TWO_SIDED|95.0|-0.375|0.413|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.413|-0.375|0.9249
73935267|NCT02819726|147399740|OTHER||LS Measn Difference|0.05|STANDARD_ERROR_OF_MEAN|0.201||0.05|TWO_SIDED|95.0|-0.351|0.442|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.442|-0.351|0.05
73935268|NCT02819726|147399740|OTHER||LS Means Diference|0.03|STANDARD_ERROR_OF_MEAN|0.205||0.8962|TWO_SIDED|95.0|-0.376|0.43|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.430|-0.376|0.8962
73935269|NCT02819726|147399741|OTHER||Difference (%)|2.2|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-2.56|7.83||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||7.83|-2.56|
73935270|NCT02819726|147399741|OTHER||Difference (%)|1.0|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-4.74|6.67||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||6.67|-4.74|
73935271|NCT02819726|147399741|OTHER||Difference (%)|-1.3|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|95.0|-6.75|3.39||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.39|-6.75|
73935272|NCT02819726|147399742|OTHER||Difference (%)|-1.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|-6.9|3.9||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.90|-6.9|
73935273|NCT02819726|147399742|OTHER||Difference (%)|-1.2|STANDARD_ERROR_OF_MEAN|1.95|||TWO_SIDED|95.0|-7.07|3.86||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.86|-7.07|
73935274|NCT02819726|147399742|OTHER||Differnce (%)|-0.1|STANDARD_ERROR_OF_MEAN|2.27|||TWO_SIDED|95.0|-6.05|5.83||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||5.83|-6.05|
73935275|NCT02819726|147399743|OTHER||Difference (%)|1.3|STANDARD_ERROR_OF_MEAN|7.19|||TWO_SIDED|95.0|-12.59|15.1||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||15.10|-12.59|
73935276|NCT02819726|147399743|OTHER||Difference (%)|0.2|STANDARD_ERROR_OF_MEAN|7.21|||TWO_SIDED|95.0|-13.75|14.03|||Difference (%)|||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||14.03|-13.75|
73935277|NCT02819726|147399743|OTHER||Difference (%)|-1.1|STANDARD_ERROR_OF_MEAN|7.29|||TWO_SIDED|95.0|-15.14|12.91||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||12.91|-15.14|
73935278|NCT02819726|147399749|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|22.1|||||TWO_SIDED|90.0|-137.1|181.3||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||181.3|-137.1|
73866098|NCT02473367|147278368|SUPERIORITY_OR_OTHER||GLSMR|0.86|||||TWO_SIDED|90.0|0.65|1.15|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||1.15|0.65|
73866099|NCT02473367|147278368|SUPERIORITY_OR_OTHER||GLSMR|0.98|||||TWO_SIDED|90.0|0.81|1.17|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||1.17|0.81|
73935279|NCT02819726|147399749|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|69.5|||||TWO_SIDED|90.0|-91.8|230.8||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||230.8|-91.8|
73866100|NCT02473367|147278369|SUPERIORITY_OR_OTHER||GLSMR|0.52|||||TWO_SIDED|90.0|0.45|0.61|||||Raltegravir+TUMS/Raltegravir only|||0.61|0.45|
73866101|NCT02473367|147278369|SUPERIORITY_OR_OTHER||GLSMR|0.42|||||TWO_SIDED|90.0|0.34|0.52|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||0.52|0.34|
73866102|NCT02473367|147278369|SUPERIORITY_OR_OTHER||GLSMR|0.43|||||TWO_SIDED|90.0|0.36|0.51|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||0.51|0.36|
73866103|NCT00454584|147278372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
73935280|NCT02819726|147399749|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|47.4|||||TWO_SIDED|90.0|-112.5|207.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||207.2|-112.5|
73935281|NCT02819726|147399749|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|310.7|||||TWO_SIDED|90.0|-187.9|809.4||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||809.4|-187.9|
73935282|NCT02819726|147399749|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|296.1|||||TWO_SIDED|90.0|-213.8|806.1||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||806.1|-213.8|
73935283|NCT02819726|147399749|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|-14.6|||||TWO_SIDED|90.0|-527.4|498.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||498.2|-527.4|
73935284|NCT00844194|147399756|SUPERIORITY_OR_OTHER||LSmean|-1.49|||<|0.0001|TWO_SIDED|95.0|-1.89|-1.1|||ANCOVA|with last observation carried forward (LOCF)||||-1.10|-1.89|< 0.0001
73935285|NCT00844194|147399756|SUPERIORITY_OR_OTHER||LSmean|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.04|||ANCOVA|||||-1.04|-2.30|< 0.0001
73935286|NCT00618657|147399871|OTHER||Standard Error|0.03|||||TWO_SIDED|||||||||||||
73935287|NCT00618657|147399871|OTHER||Standard Error|0.03|||||TWO_SIDED|||||||||||||
73935288|NCT00795600|147399958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.645|STANDARD_ERROR_OF_MEAN|3.364||0.849||95.0|-7.404|6.114||H01 (hypothesis): Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||6.114|-7.404|0.849
73935289|NCT00795600|147399959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|3.478||0.948||95.0|-7.588|6.407||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||6.407|-7.588|0.948
73972675|NCT06193070|147487255|OTHER|A one-tailed paired t-test was run to examine within subject mean difference on the cancer nutrition information beliefs scale pre- and post-game.|||||<|0.001||||||The threshold was set at alpha \< 0.05.|t-test, 1 sided|A paired samples t-test was run on pre- and post-game mean scores within subjects.||All participants were exposed to the intervention, and pre- and post-game scores within subject were examined.||||<.001
73972676|NCT03926130|147487269|SUPERIORITY||Risk Difference (RD)|28.7|||<|1e-06|TWO_SIDED|95.0|23.0|34.4|||Cochran-Mantel-Haenszel|||||34.4|23.0|<0.000001
73972677|NCT03926130|147487270|SUPERIORITY||Risk Difference (RD)|25.8|||<|1e-06|TWO_SIDED|95.0|18.8|32.7|||Cochran-Mantel-Haenszel|||||32.7|18.8|<0.000001
73935290|NCT00795600|147399960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|196.36|STANDARD_ERROR_OF_MEAN|498.7||0.696||95.0|-805.8|1198.5||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||1198.5|-805.8|0.696
73935291|NCT00795600|147399961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|192.81|STANDARD_ERROR_OF_MEAN|515.4||0.71||95.0|-844.0|1229.7||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||1229.7|-844.0|0.710
73935292|NCT00795600|147399962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|288.21|STANDARD_ERROR_OF_MEAN|766.41||0.709||95.0|-1252.0|1828.4|||ANCOVA|||||1828.4|-1252.0|0.709
73972678|NCT03926130|147487271|SUPERIORITY||Risk Difference (RD)|19.7|||<|1e-06|TWO_SIDED|95.0|13.7|25.6|||Cochran-Mantel-Haenszel|||||25.6|13.7|<0.000001
73972679|NCT03926130|147487272|SUPERIORITY||Risk Difference (RD)|39.1|||<|1e-06|TWO_SIDED|95.0|33.4|44.8|||Cochran-Mantel-Haenszel|||||44.8|33.4|<0.000001
73972680|NCT03926130|147487272|SUPERIORITY||Risk Difference (RD)|2.3||||0.513623|TWO_SIDED|95.0|-4.7|9.3|||Cochran-Mantel-Haenszel|||||9.3|-4.7|0.513623
73972681|NCT03926130|147487273|SUPERIORITY||Risk Difference (RD)|12.4||||0.001431|TWO_SIDED|95.0|5.3|19.6|||Cochran-Mantel-Haenszel|||||19.6|5.3|0.001431
73972682|NCT03926130|147487274|SUPERIORITY||Risk Difference (RD)|34.6|||<|1e-06|TWO_SIDED|95.0|27.7|41.4|||Cochran-Mantel-Haenszel|||||41.4|27.7|<0.000001
73972683|NCT03926130|147487274|NON_INFERIORITY|The non-inferiority margin is 10%. We do not have power calculation in the SAP for this endpoint.|Risk Difference (RD)|5.7|||<|0.0001|TWO_SIDED|95.0|-1.4|12.8|||Z test|||||12.8|-1.4|<0.0001
73972684|NCT03926130|147487275|SUPERIORITY||Risk Difference (RD)|6.8||||0.003414|TWO_SIDED|95.0|3.2|10.5|||Cochran-Mantel-Haenszel|||||10.5|3.2|0.003414
73972685|NCT03926130|147487276|SUPERIORITY||LSMean Difference (Net)|-0.86||||1.1e-05|TWO_SIDED|95.0|-1.24|-0.48|||ANCOVA|||||-0.48|-1.24|0.000011
73972686|NCT03926130|147487277|SUPERIORITY||LSMean Difference (Net)|-2.01|||<|1e-06|TWO_SIDED|95.0|-2.42|-1.6|||ANCOVA|||||-1.60|-2.42|<0.000001
73972687|NCT03926130|147487278|SUPERIORITY||Risk Difference (RD)|25.7|||<|1e-06|TWO_SIDED|95.0|18.9|32.6|||Cochran-Mantel-Haenszel|||||32.6|18.9|<0.000001
73972688|NCT03926130|147487279|SUPERIORITY||Risk Difference (RD)|13.8|||<|1e-06|TWO_SIDED|95.0|10.2|17.4|||Cochran-Mantel-Haenszel|||||17.4|10.2|<0.000001
73972689|NCT03926130|147487280|SUPERIORITY||Risk Difference (RD)|25.0|||<|1e-06|TWO_SIDED|95.0|18.2|31.8|||Cochran-Mantel-Haenszel|||||31.8|18.2|<0.000001
73972690|NCT03926130|147487281|SUPERIORITY||LSMean Difference (Net)|-0.85|||<|1e-06|TWO_SIDED|95.0|-1.05|-0.65|||ANCOVA|||||-0.65|-1.05|<0.000001
74030469|NCT02078713|147615171|SUPERIORITY||Odds Ratio (OR)|1.83||||0.11|TWO_SIDED|95.0|0.88|3.8||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||3.80|0.88|0.11
74030470|NCT00696657|147615180|SUPERIORITY||Estimated treatment differences|-1.19|||<|0.0001|TWO_SIDED|95.0|-1.58|-0.8|||ANOVA|Confidence interval (CIs) for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Placebo. The estimates are from an analysis of variance (ANOVA) model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.80|-1.58|<0.0001
74030471|NCT00696657|147615180|SUPERIORITY||Estimated treatment differences|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.57|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.57|-1.33|<0.0001
74030472|NCT00696657|147615180|SUPERIORITY||Estimated treatment differences|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.35|-0.59|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.8 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.59|-1.35|<0.0001
74030473|NCT00696657|147615180|SUPERIORITY||Estimated treatment differences|-0.61||||0.0002|TWO_SIDED|95.0|-0.98|-0.23|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.4 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.23|-0.98|0.0002
74088863|NCT00680186|147730895|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||||95.0|0.64|1.8|||Regression, Cox|Patients without events are censored at the earliest of last contact date or day 180.||HR vs. Warfarin (events occurring between randomisation and day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE. This analysis was performed as sensitivity analysis for statistical analysis 1.||1.8|0.64|
73935293|NCT00795600|147399963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|2.732||0.948||95.0|-5.668|5.313|||ANCOVA|||||5.313|-5.668|0.948
73935294|NCT00795600|147399964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1151.0|STANDARD_ERROR_OF_MEAN|810.48||0.162||95.0|-2780.0|477.33|||ANCOVA|||||477.33|-2780.0|0.162
73935295|NCT00795600|147399965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.747|STANDARD_ERROR_OF_MEAN|1.788||0.131||95.0|-6.34|0.846|||ANCOVA|||||0.846|-6.340|0.131
73935296|NCT00795600|147399966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-110.4|STANDARD_ERROR_OF_MEAN|368.69||0.766||95.0|-851.3|630.51|||ANCOVA|||||630.51|-851.3|0.766
73935297|NCT00795600|147399967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|1.662||0.716||95.0|-3.949|2.729|||ANCOVA|||||2.729|-3.949|0.716
73935298|NCT00795600|147399968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.491|STANDARD_ERROR_OF_MEAN|0.695||0.483||95.0|-0.906|1.888|||ANCOVA|||||1.888|-0.906|0.483
73935299|NCT00795600|147399969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|1.909||0.952||95.0|-3.721|3.953|||ANCOVA|||||3.953|-3.721|0.952
74030474|NCT00696657|147615180|SUPERIORITY||Estimated treatment differences|-0.41||||0.0324|TWO_SIDED|95.0|-0.79|-0.02|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.02|-0.79|0.0324
73935300|NCT00795600|147399970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278|STANDARD_ERROR_OF_MEAN|0.746||0.711||95.0|-1.778|1.221|||ANCOVA|||||1.221|-1.778|0.711
73935301|NCT00795600|147399971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.585|STANDARD_ERROR_OF_MEAN|1.854||0.397||95.0|-5.31|2.141|||ANCOVA|||||2.141|-5.310|0.397
73935302|NCT00795600|147399972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.916|STANDARD_ERROR_OF_MEAN|10.985||0.421||95.0|-30.99|13.159|||ANCOVA|||||13.159|-30.99|0.421
73935303|NCT00795600|147399973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.061|STANDARD_ERROR_OF_MEAN|6.216||0.42||95.0|-17.55|7.43|||ANCOVA|||||7.430|-17.55|0.420
73935304|NCT00795600|147399974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.961|STANDARD_ERROR_OF_MEAN|13.007||0.705||95.0|-31.1|21.178|||ANCOVA|||||21.178|-31.10|0.705
73935305|NCT00795600|147399975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.59|STANDARD_ERROR_OF_MEAN|4.776||0.341||95.0|-14.19|5.007|||ANCOVA|||||5.007|-14.19|0.341
73935306|NCT00795600|147399976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.034||0.902||95.0|-0.064|0.073|||ANCOVA|||||0.073|-0.064|0.902
73935307|NCT00795600|147399977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.789|STANDARD_ERROR_OF_MEAN|3.85||0.839||95.0|-8.525|6.947|||ANCOVA|||||6.947|-8.525|0.839
73935308|NCT00795600|147399978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.041||0.607||95.0|-0.105|0.062|||ANCOVA|||||0.062|-0.105|0.607
73972691|NCT03926130|147487282|SUPERIORITY||LSMean Difference (Net)|-1.22|||<|1e-06|TWO_SIDED|95.0|-1.48|-0.95|||ANCOVA|||||-0.95|-1.48|<0.000001
73972692|NCT03926130|147487283|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73972693|NCT03926130|147487284|SUPERIORITY||Risk Difference (RD)|4.1||||0.732715|TWO_SIDED|95.0|-18.0|26.1|||Cochran-Mantel-Haenszel|||||26.1|-18.0|0.732715
73972694|NCT03926130|147487285|SUPERIORITY||LSMean Difference (Net)|27.92|||<|1e-06|TWO_SIDED|95.0|22.67|33.18|||ANCOVA|||||33.18|22.67|<0.000001
73935309|NCT00795600|147399979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.777|STANDARD_ERROR_OF_MEAN|3.719||0.635||95.0|-9.254|5.7|||ANCOVA|||||5.700|-9.254|0.635
73935310|NCT00795600|147399980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.266||0.628||95.0|-0.663|0.403|||ANCOVA|||||0.403|-0.663|0.628
73935311|NCT00795600|147399981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.92|STANDARD_ERROR_OF_MEAN|17.46||0.535||95.0|-46.03|24.182|||ANCOVA|||||24.182|-46.03|0.535
73935312|NCT00795600|147399982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.918|STANDARD_ERROR_OF_MEAN|4.332||0.66||95.0|-10.65|6.813|||ANCOVA|||||6.813|-10.65|0.660
73935313|NCT00795600|147400009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.629|STANDARD_ERROR_OF_MEAN|0.967||0.518||95.0|-2.572|1.313|||ANCOVA|||||1.313|-2.572|0.518
73935314|NCT00795600|147400010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.546|STANDARD_ERROR_OF_MEAN|1.283||0.673||95.0|-3.123|2.032|||ANCOVA|||||2.032|-3.123|0.673
73935315|NCT00795600|147400011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|1.386||0.738||95.0|-2.319|3.25|||ANCOVA|||||3.250|-2.319|0.738
73935316|NCT00795600|147400012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.062|STANDARD_ERROR_OF_MEAN|2.168||0.346||95.0|-2.3|6.423|||ANCOVA|||||6.423|-2.300|0.346
73935317|NCT00795600|147400013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.726|STANDARD_ERROR_OF_MEAN|6.173||0.781||95.0|-10.71|14.167|||ANCOVA|||||14.167|-10.71|0.781
73935318|NCT01381172|147400056|OTHER|The primary analysis employed a Bayesian repeated measures linear model to estimate group differences in mean pVO2 at 24 weeks from baseline, with 30% borrowing of information (70% down-weighting) from the corresponding treatment group difference observed in the FIX-5 study subgroup. The Bayesian posterior probability would need to be \> 0.975 to be considered a positive result with statistical significance.||||||0.975||||||The posterior probability (Pr) that the mean difference in pVO2 (Δ3) between device and control groups is greater than zero must exceed 0.975 to meet the primary effectiveness endpoint.|Bayesian posterior probability|||The FIX-HF-5C Study was a study designed to confirm the preliminary evidence reported in the FIX-HF-5 subgroup analysis demonstrating improvement in subjects with LVEF 25-45% and NYHA class III-IV. A Bayesian statistical approach was employed to leverage the data available, particularly the pVO2 results, from the FIX-HF-5 subgroup.||||0.975
73935319|NCT01666002|147400063|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73935320|NCT01666002|147400064|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73935321|NCT01248884|147400073|NON_INFERIORITY|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.3||||||||2.3|-2.25|
73935322|NCT01248884|147400073|NON_INFERIORITY|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.3||||||||2.3|-2.25|
73935323|NCT01248884|147400073|NON_INFERIORITY|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.27||||||||2.27|-2.25|
73935324|NCT01248884|147400073|NON_INFERIORITY|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.27||||||||2.27|-2.25|
73935325|NCT01248884|147400075|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.26|||||TWO_SIDED|97.5|1.11|1.44||||||||1.44|1.11|
73935326|NCT01248884|147400075|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.33|||||TWO_SIDED|97.5|1.14|1.54||||||||1.54|1.14|
73935327|NCT01248884|147400075|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.25|||||TWO_SIDED|97.5|1.1|1.43||||||||1.43|1.1|
73935328|NCT01248884|147400075|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.58|||||TWO_SIDED|97.5|1.37|1.84||||||||1.84|1.37|
73935329|NCT01248884|147400076|NON_INFERIORITY|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-3.52|||||TWO_SIDED|97.5|-10.19|3.0||||||||3|-10.19|
73935330|NCT01248884|147400076|NON_INFERIORITY|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.57|||||TWO_SIDED|97.5|-6.53|7.7||||||||7.7|-6.53|
73935331|NCT01248884|147400077|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.56|||||TWO_SIDED|97.5|-3.27|4.63||||||Immune response non-inferiority - anti-HBs (ELISA)||4.63|-3.27|
73935332|NCT01248884|147400077|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.94|||||TWO_SIDED|97.5|-4.57|2.36||||||Immune response non-inferiority - anti-HBs (ELISA)||2.36|-4.57|
73935333|NCT01248884|147400077|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.4|||||TWO_SIDED|97.5|-4.62|3.8||||||Immune response non-inferiority - anti-HBs (CLIA)||3.8|-4.62|
73935334|NCT01248884|147400077|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.92|||||TWO_SIDED|97.5|-5.07|3.02||||||Immune response non-inferiority - anti-HBs (CLIA)||3.02|-5.07|
73935335|NCT02334800|147400125|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|73.6|||||TWO_SIDED|90.0|57.81|93.71||||||||93.71|57.81|
73935336|NCT02334800|147400125|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|115.3|||||TWO_SIDED|90.0|90.57|146.79||||||||146.79|90.57|
73935337|NCT02334800|147400125|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|133.68|||||TWO_SIDED|90.0|105.0|170.19||||||||170.19|105.00|
73935338|NCT02334800|147400126|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|94.99|||||TWO_SIDED|90.0|69.93|129.03||||||||129.03|69.93|
73935339|NCT02334800|147400126|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|117.75|||||TWO_SIDED|90.0|86.69|159.95||||||||159.95|86.69|
73935340|NCT02334800|147400126|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|129.89|||||TWO_SIDED|90.0|95.63|176.43||||||||176.43|95.63|
73935341|NCT02334800|147400127|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|83.01|||||TWO_SIDED|90.0|65.37|105.43||||||||105.43|65.37|
73935342|NCT02334800|147400127|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.28|||||TWO_SIDED|90.0|105.73|170.53||||||||170.53|105.73|
73972695|NCT03926130|147487287|SUPERIORITY||Risk Difference (RD)|10.6||||0.000213|TWO_SIDED|99.5|4.1|17.2|||Cochran-Mantel-Haenszel|||||17.2|4.1|0.000213
73935343|NCT02334800|147400127|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|176.88|||||TWO_SIDED|90.0|139.28|224.63||||||||224.63|139.28|
73935344|NCT02334800|147400128|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|72.81|||||TWO_SIDED|90.0|56.43|93.93||||||||93.93|56.43|
73935345|NCT02334800|147400128|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|115.57|||||TWO_SIDED|90.0|89.58|149.11||||||||149.11|89.58|
73935346|NCT02334800|147400128|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.66|||||TWO_SIDED|90.0|104.38|173.73||||||||173.73|104.38|
73935347|NCT02334800|147400129|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|82.14|||||TWO_SIDED|90.0|63.83|105.71||||||||105.71|63.83|
73935348|NCT02334800|147400129|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.9|||||TWO_SIDED|90.0|104.82|173.6||||||||173.60|104.82|
73935349|NCT02334800|147400129|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|178.39|||||TWO_SIDED|90.0|138.62|229.57||||||||229.57|138.62|
73972696|NCT03926130|147487288|SUPERIORITY||Risk Difference (RD)|19.4|||<|1e-06|TWO_SIDED|99.5|13.1|25.7|||Cochran-Mantel-Haenszel|||||25.7|13.1|<0.000001
73972697|NCT03583333|147487289|NON_INFERIORITY|Non-inferiority margin for the difference in mortality (IMI/REL minus PIP/TAZ) was 12.5%.|Adjusted difference in percentage|5.2||||0.024|TWO_SIDED|95.0|-1.5|12.4|||Miettinen & Nurminen method||Adjusted differences and the 95% confidence intervals (CIs) are based on Miettinen \& Nurminen method stratified by randomization stratum.|||12.4|-1.5|0.024
73972698|NCT03583333|147487289|SUPERIORITY||Adjusted difference in percentage|5.2||||0.938|TWO_SIDED|95.0|-1.5|12.4|||Miettinen & Nurminen|Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.||||12.4|-1.5|0.938
73935350|NCT02334800|147400132|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|107.37|||||TWO_SIDED|90.0|78.06|147.68||||||||147.68|78.06|
73935351|NCT02334800|147400132|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|137.5|||||TWO_SIDED|90.0|99.96|189.12||||||||189.12|99.96|
73935352|NCT02334800|147400132|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|172.27|||||TWO_SIDED|90.0|125.25|236.96||||||||236.96|125.25|
73935353|NCT02703844|147400151|SUPERIORITY|||||||0.0089|||||||ANCOVA|||||||0.0089
73935354|NCT00801684|147400165|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The difference between the active treatment was compared to placebo. For a null hypothesis, the difference would equal 0 (zero).||||<0.0001
73935355|NCT02828111|147400169|OTHER|Pairwise comparison||||||0.132|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.132
73935356|NCT02828111|147400169|OTHER|Pairwise comparison||||||0.658|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.658
73935357|NCT02828111|147400169|OTHER|Pairwise comparison||||||0.142|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.142
73935358|NCT02828111|147400169|OTHER|Pairwise comparison||||||0.207|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.207
73935359|NCT02828111|147400169|OTHER|Pairwise comparison||||||0.077|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.||||0.077
73935360|NCT02828111|147400169|OTHER|Pairwise comparison||||||0.331|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.||||0.331
73935361|NCT02828111|147400169|OTHER|Pairwise comparison||||||0.117|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of all four patidegib gel treatment groups combined compared with vehicle gel at Week 12.||||0.117
73935362|NCT02828111|147400173|OTHER|Pairwise comparison||||||0.038|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.038
73935363|NCT02828111|147400173|OTHER|Pairwise comparison||||||0.099|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.099
73972699|NCT03583333|147487290|OTHER||Adjusted difference in percentage|3.1|||||TWO_SIDED|95.0|-8.7|14.9|||||Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.9|-8.7|
73935364|NCT02828111|147400173|OTHER|Pairwise comparison||||||0.198|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.198
73935365|NCT02828111|147400173|OTHER|Pairwise comparison||||||0.757|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.757
73935366|NCT02828111|147400174|OTHER|Pairwise comparison||||||0.043|||||||Fisher Exact|||at Week 12||||0.043
73935367|NCT02828111|147400174|OTHER|Pairwise comparison||||||0.312|||||||Fisher Exact|||at Week 12||||0.312
73935368|NCT02828111|147400174|OTHER|Pairwise comparison||||||0.353|||||||Fisher Exact|||at Week 12||||0.353
73935369|NCT02828111|147400174|OTHER|Pairwise comparison||||||0.093|||||||Fisher Exact|||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.||||0.093
73935370|NCT02828111|147400174|OTHER|Pairwise comparison||||||1|||||||Fisher Exact|||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.||||1.000
73935371|NCT02828111|147400174|OTHER|Pairwise comparison||||||0.157|||||||Fisher Exact|||This is the analysis of all four patidegib gel treatment groups combined compared with combined vehicle gel at Week 12.||||0.157
73935372|NCT02667912|147400176|SUPERIORITY||Mean Difference (Final Values)|10.8||||0.045|TWO_SIDED|95.0|0.3|21.4||The a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||21.4|0.3|0.045
73935373|NCT02667912|147400179|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
73935374|NCT02667912|147400180|OTHER|||||||0.203|||||||t-test, 2 sided|||||||0.203
73935375|NCT02667912|147400181|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.27|TWO_SIDED|95.0|-11.9|3.4|||t-test, 2 sided|||||3.4|-11.9|0.27
73935376|NCT02667912|147400182|SUPERIORITY||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|5.7||0.17|TWO_SIDED|95.0|-3.7|19.3||The a priori threshold for statistical significance p\<0.05|t-test, 2 sided|||||19.3|-3.7|0.17
73935377|NCT02667912|147400185|SUPERIORITY|||||||0.213|||||||t-test, 2 sided|||||||0.213
73935378|NCT02667912|147400186|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|||||||0.041
73935379|NCT02667912|147400187|OTHER|||||||0.304|||||||t-test, 2 sided|||||||0.304
73935380|NCT02667912|147400188|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
73935381|NCT02667912|147400189|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
73935382|NCT02667912|147400190|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
73935383|NCT02667912|147400191|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
73935384|NCT02667912|147400192|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
73935385|NCT02667912|147400193|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||0.054
73935386|NCT02667912|147400194|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
73935387|NCT02667912|147400195|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||||||0.324
73935388|NCT02667912|147400196|SUPERIORITY|||||||0.217|||||||t-test, 2 sided|||||||0.217
73972700|NCT03583333|147487291|OTHER||Adjusted difference in percentage|2.2|||||TWO_SIDED|95.0|-12.4|16.8|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||16.8|-12.4|
73972701|NCT03583333|147487292|OTHER||Adjusted difference in percentage|3.4|||||TWO_SIDED|95.0|-7.6|14.3|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.3|-7.6|
73935389|NCT02667912|147400197|SUPERIORITY|||||||0.238|||||||t-test, 2 sided|||||||0.238
73935390|NCT02667912|147400198|SUPERIORITY|||||||0.969|||||||t-test, 2 sided|||||||0.969
73935391|NCT02667912|147400199|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
73935392|NCT00022516|147400224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.14|TWO_SIDED|95.0|0.6|1.06|||Log Rank|||||1.06|0.6|0.14
73935393|NCT00022516|147400225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.357|TWO_SIDED|95.0|0.65|1.17|||Log Rank|||||1.17|0.65|0.3570
73935394|NCT00022516|147400226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.3178|TWO_SIDED|95.0|0.62|1.17|||Log Rank|||||1.17|0.62|0.3178
73935395|NCT00022516|147400227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.06|TWO_SIDED|95.0|0.6|1.01|||Log Rank|||||1.01|0.6|0.06
73935396|NCT02207829|147400250|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis: the difference between the trt means (umeclidinium minus tiotropium) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to tiotropium.|Mean Difference (Final Values)|0.059|||<|0.001|TWO_SIDED|95.0|0.029|0.088|||Mixed Models Analysis|||||0.088|0.029|<0.001
73935397|NCT03283670|147400255|SUPERIORITY||Mean Difference (Net)|-0.75||||0.55|TWO_SIDED||||||t-test, 2 sided|||HAMD-21 at 2 Hours, placebo vs 25% nitrous oxide||||0.55
73935398|NCT03283670|147400255|SUPERIORITY||Mean Difference (Net)|-1.4||||0.47|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21, 25% nitrous oxide vs placebo at 24 hours||||0.47
73935399|NCT03283670|147400255|SUPERIORITY||Median Difference (Net)|-0.87||||0.49|TWO_SIDED||||||t-test, 2 sided|||HAMD-21 at 2 Hours, placebo vs 50% nitrous oxide||||0.49
73935400|NCT03283670|147400255|SUPERIORITY||Mean Difference (Net)|-1.9||||0.34|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 24 hours, placebo vs 50% nitrous oxide||||0.34
73935401|NCT03283670|147400255|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.94|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 2 hours, 25% nitrous oxide vs 50% nitrous oxide||||0.94
73935402|NCT03283670|147400255|SUPERIORITY||Mean Difference (Net)|-0.5||||0.8|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 24 hours, 25% nitrous oxide vs 50% nitrous oxide||||0.80
73935403|NCT05932290|147400264|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.71|||Regression, Cox||Hazard ratios (HRs) were estimated using unadjusted Cox proportional hazard models.|||0.71|0.37|<.0001
73935404|NCT05932290|147400265|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.0003|TWO_SIDED|95.0|0.22|0.64|||Regression, Cox||IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.|||0.64|0.22|.0003
73935405|NCT05932290|147400268|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0062|TWO_SIDED|95.0|0.47|0.88|||Regression, Cox||HRs were estimated using unadjusted Cox proportional hazard models.|||0.88|0.47|.0062
73972702|NCT03583333|147487293|OTHER||Adjusted difference in percentage|-4.7|||||TWO_SIDED|95.0|-15.8|6.6|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||6.6|-15.8|
73935406|NCT05932290|147400269|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.0032|TWO_SIDED|95.0|0.27|0.77|||Regression, Cox|IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.||||0.77|0.27|.0032
73866104|NCT00454584|147278372|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||To control the overall type I error rate at 0.05 level in the primary endpoint analysis, a step-down test procedure was applied. First, ustekinumab 90 mg and etanercept were compared. Then ustekinumab 45 mg and etanercept would be compared.|Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05. Sample Size: Assuming the PASI 75 response rates of ustekinumab 90 mg, 45 mg, etanercept are 65%, 64%, and 50% , respectively, with 325 participants each in the ustekinumab 90 mg and etanercept groups, the power to detect a treatment difference is 97%. With 200 participants in the ustekinumab 45 mg group, the complete power to further detect a treatment difference was 87%.||||0.012
73866105|NCT00454584|147278373|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
73866106|NCT00454584|147278373|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.||||<0.001
73935407|NCT01255358|147400302|OTHER|Changes from baseline (V1) at V2, V4 and V7 were analyzed with a RMANOVA design with age and ICARS at baseline as covariates. A Wilcoxon non-parametric test between visits was performed when the overall analysis was significant in order to help determine timing of effects|Mean Difference (Final Values)|-4.0|STANDARD_DEVIATION|7.5||0.02|TWO_SIDED|95.0|-7.1|-0.9|||Wilcoxon (Mann-Whitney)|||The primary analysis on ICARS Total score has been conducted on the ITT Population employing carry-forward and carry-backward procedures for missing data imputation, in order to evaluate all enrolled patients.||-0.9|-7.1|0.02
73935408|NCT01255358|147400303|OTHER|Changes from baseline (V1) at V2, V4 and V7 were analyzed with a RMANOVA design with age and ICARS at baseline as covariates. A Wilcoxon non-parametric test between visits was performed when the overall analysis was significant in order to help determine timing of effects|Mean Difference (Final Values)|-5.2|STANDARD_DEVIATION|7.0||0.0031|TWO_SIDED|95.0|-8.4|-2.0|||Wilcoxon (Mann-Whitney)|||Overall analysis on the PP Population||-2|-8.4|0.0031
73935409|NCT01255358|147400308|OTHER|VABS Total score and subscales have been analyzed with a RMANOVA design, using age as covariate (dichotomized as Low- or High-, using median age as threshold).|Median Difference (Final Values)|1.3|STANDARD_DEVIATION|1.2|<|0.0001|TWO_SIDED|95.0|0.8|1.8|||Wilcoxon (Mann-Whitney)|||VABS total score at V7||1.8|0.8|<0.0001
73972703|NCT03583333|147487294|OTHER||Adjusted difference in percentage|-2.4|||||TWO_SIDED|95.0|-17.8|13.1|||||Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||13.1|-17.8|
73972704|NCT03583333|147487295|OTHER||Adjusted difference in percentage|1.4|||||TWO_SIDED|95.0|-16.5|19.8|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||19.8|-16.5|
73972705|NCT03583333|147487296|OTHER||Adjusted difference in percentage|-3.1|||||TWO_SIDED|95.0|-19.8|14.4|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.4|-19.8|
73935410|NCT01255358|147400309|OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|1.1|<|0.0001|TWO_SIDED|95.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|1|<0.0001
73935411|NCT03029208|147400343|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|Least square (LS) mean difference|-0.1|||||TWO_SIDED|95.0|-0.34|0.14|||||An ANCOVA model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95% CI for the treatment difference (daprodustat-darbepoetin alfa).|||0.14|-0.34|
73935412|NCT03029208|147400344|SUPERIORITY||LS mean difference|19.4||||0.8949|TWO_SIDED|95.0|-11.0|49.9|||ANCOVA||An ANCOVA model was used to compare the difference in this average monthly IV iron dose between arms, including factors for Baseline dose, treatment and the randomization stratification factors.|||49.9|-11.0|0.8949
73935413|NCT03029208|147400345|SUPERIORITY||LS mean difference|3.23||||0.8168|TWO_SIDED|95.0|-3.82|10.27|||Mixed model repeated measures (MMRM)||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||10.27|-3.82|0.8168
73935414|NCT03029208|147400345|SUPERIORITY||LS mean difference|4.21||||0.9793|TWO_SIDED|95.0|0.17|8.26|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||8.26|0.17|0.9793
73935415|NCT03029208|147400345|SUPERIORITY||LS mean difference|4.1||||0.9597|TWO_SIDED|95.0|-0.51|8.7|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||8.70|-0.51|0.9597
73935416|NCT03029208|147400346|SUPERIORITY||LS mean difference|-0.09||||0.484|TWO_SIDED|95.0|-4.72|4.53|||ANCOVA||The difference in change from Baseline in SBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.53|-4.72|0.4840
73972706|NCT03583333|147487297|OTHER||Adjusted difference in percentage|2.0|||||TWO_SIDED|95.0|-6.5|10.6|||||Difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||10.6|-6.5|
73972707|NCT03583333|147487298|OTHER||Adjusted difference in percentage|-4.4|||||TWO_SIDED|95.0|-10.7|1.4|||||Difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||1.4|-10.7|
73972708|NCT03687762|147487331|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972709|NCT03687762|147487332|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972710|NCT03687762|147487333|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
74030475|NCT00696657|147615180|SUPERIORITY||Estimated treatment differences|-0.09||||0.9772|TWO_SIDED|95.0|-0.46|0.28|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.1 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.28|-0.46|0.9772
74030476|NCT00696657|147615180|OTHER||Estimated treatment differences|-0.35|||||TWO_SIDED|95.0|-0.64|-0.06|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.06|-0.64|
73935417|NCT03029208|147400346|SUPERIORITY||LS mean difference|1.99||||0.9156|TWO_SIDED|95.0|-0.85|4.82|||ANCOVA||The difference in change from Baseline in DBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.82|-0.85|0.9156
73935418|NCT03029208|147400346|SUPERIORITY||LS mean difference|1.29||||0.7966|TWO_SIDED|95.0|-1.76|4.33|||ANCOVA||The difference in change from Baseline in MAP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.33|-1.76|0.7966
74030477|NCT00696657|147615180|OTHER||Estimated treatment differences|-0.11|||||TWO_SIDED|95.0|-0.39|0.18|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.18|-0.39|
74030478|NCT00696657|147615180|OTHER||Estimated treatment differences|-0.13|||||TWO_SIDED|95.0|-0.42|0.16|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.16|-0.42|
74030479|NCT00696657|147615180|OTHER||Estimated treatment differences|0.24|||||TWO_SIDED|95.0|-0.05|0.52|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.52|-0.05|
74030480|NCT00696657|147615180|OTHER||Estimated treatment differences|0.44|||||TWO_SIDED|95.0|0.15|0.73|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.73|0.15|
73935419|NCT03029208|147400347|SUPERIORITY||Ratio of exacerbation rate|1.01||||0.5174|TWO_SIDED|95.0|0.73|1.39|||Negative binomial model||Model estimated exacerbation rates, ratio of model estimated exacerbation rates and CIs were estimated using a negative binomial model for the treatment group comparison.|||1.39|0.73|0.5174
73935420|NCT03029208|147400349|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.04|||||TWO_SIDED|95.0|-0.29|0.36|||||The difference in change from Baseline in post-randomization Hgb at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||0.36|-0.29|
73935421|NCT03029208|147400350|SUPERIORITY||Difference in response rate|-0.8||||0.5411|TWO_SIDED|95.0|-12.2|10.7|||Cochran-Mantel-Haenszel||A Cochran-Mantel-Haenszel (CMH) test adjusted for treatment and randomization stratification factors were used to compare the number of responders between the treatment groups.|||10.7|-12.2|0.5411
73866107|NCT00454584|147278374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
73935422|NCT03029208|147400351|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|2.05|||||TWO_SIDED|95.0|-4.45|11.27|||||Hodges-Lehmann Estimate of Treatment Difference has been reported.|||11.27|-4.45|
73935423|NCT03029208|147400352|SUPERIORITY||Probability|0.54||||0.1538|TWO_SIDED|95.0|0.46|0.61|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.61|0.46|0.1538
74030481|NCT00696657|147615180|OTHER||Estimated treatment differences|0.75|||||TWO_SIDED|95.0|0.48|1.03|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||1.03|0.48|
74030482|NCT00696657|147615180|OTHER||Estimated treatment differences|-0.84|||||TWO_SIDED|95.0|-1.12|-0.56|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Liraglutide 1.8 mg - Placebo . The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.56|-1.12|
74030483|NCT00696657|147615180|OTHER||Estimated treatment differences|-0.51|||||TWO_SIDED|95.0|-0.8|-0.22|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.22|-0.80|
73866108|NCT00454584|147278374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.||||<0.001
73935424|NCT03029208|147400353|OTHER||Hazard Ratio (HR)|1.06||||0.5348|TWO_SIDED|95.0|0.31|3.66|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, dialysis type and dialysis start manner.|||3.66|0.31|0.5348
73866109|NCT00454181|147278378|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response.||||0.30
73866110|NCT00454181|147278379|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response||||0.26
73935425|NCT03029208|147400354|SUPERIORITY||LS mean difference|-0.39||||0.6641|TWO_SIDED|95.0|-2.22|1.44|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.44|-2.22|0.6641
73935426|NCT03029208|147400354|SUPERIORITY||LS mean difference|1.13||||0.103|TWO_SIDED|95.0|-0.63|2.89|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.89|-0.63|0.1030
73935427|NCT03029208|147400354|SUPERIORITY||LS mean difference|0.49||||0.3157|TWO_SIDED|95.0|-1.51|2.48|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.48|-1.51|0.3157
73935428|NCT03029208|147400354|SUPERIORITY||LS mean difference|-1.31||||0.8855|TWO_SIDED|95.0|-3.46|0.84|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||0.84|-3.46|0.8855
73935429|NCT03029208|147400355|SUPERIORITY||LS mean difference|-0.67||||0.7146|TWO_SIDED|95.0|-2.99|1.66|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.66|-2.99|0.7146
73935430|NCT03029208|147400355|SUPERIORITY||LS mean difference|-1.53||||0.905|TWO_SIDED|95.0|-3.82|0.76|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||0.76|-3.82|0.9050
73935431|NCT03029208|147400355|SUPERIORITY||LS mean difference|-0.32||||0.595|TWO_SIDED|95.0|-2.91|2.28|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.28|-2.91|0.5950
73972711|NCT03687762|147487334|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
74030484|NCT00696657|147615180|OTHER||Estimated treatment differences|-0.27|||||TWO_SIDED|95.0|-0.56|0.02|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.02|-0.56|
73866111|NCT00454181|147278380|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in oral warts from baseline to week 24 as better."||||0.50
73935432|NCT03029208|147400355|SUPERIORITY||LS mean difference|-0.23||||0.5619|TWO_SIDED|95.0|-3.17|2.7|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.70|-3.17|0.5619
74030485|NCT00696657|147615180|OTHER||Estimated treatment differences|-0.29|||||TWO_SIDED|95.0|-0.58|0.01|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.01|-0.58|
73866112|NCT00454181|147278381|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in global oral health from baseline to week 24 as better."||||0.29
73935433|NCT03029208|147400356|SUPERIORITY||LS mean difference|0.14||||0.4523|TWO_SIDED|95.0|-2.21|2.49|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||2.49|-2.21|0.4523
73935434|NCT03029208|147400356|SUPERIORITY||LS mean difference|-0.07||||0.5222|TWO_SIDED|95.0|-2.57|2.43|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.43|-2.57|0.5222
73935435|NCT03029208|147400356|SUPERIORITY||LS mean difference|2.33||||0.044|TWO_SIDED|95.0|-0.35|5.02|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||5.02|-0.35|0.0440
73935436|NCT03029208|147400356|SUPERIORITY||LS mean difference|-2.61||||0.9523|TWO_SIDED|95.0|-5.68|0.46|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||0.46|-5.68|0.9523
73866113|NCT00454181|147278382|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with respect to changes in oral warts from baseline to week 24 by the attending investigator."||||0.74
73866114|NCT00454181|147278383|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with resepect to changes from baseline to week 24 in global oral health by the attending investigator."||||.71
73972712|NCT03687762|147487335|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972713|NCT03687762|147487336|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.||||||0.01|||||||ANOVA|||||||0.01
73972714|NCT03687762|147487337|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972715|NCT03687762|147487338|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73935437|NCT03029208|147400356|SUPERIORITY||LS mean difference|0.05||||0.4811|TWO_SIDED|95.0|-1.82|1.91|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.91|-1.82|0.4811
73935438|NCT03029208|147400356|SUPERIORITY||LS mean difference|0.28||||0.3834|TWO_SIDED|95.0|-1.56|2.11|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.11|-1.56|0.3834
73935439|NCT03029208|147400356|SUPERIORITY||LS mean difference|0.26||||0.3983|TWO_SIDED|95.0|-1.72|2.24|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.24|-1.72|0.3983
73935440|NCT03029208|147400356|SUPERIORITY||LS mean difference|-0.18||||0.5617|TWO_SIDED|95.0|-2.51|2.15|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.15|-2.51|0.5617
73935441|NCT03029208|147400356|SUPERIORITY||LS mean difference|-1.15||||0.8336|TWO_SIDED|95.0|-3.48|1.18|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.18|-3.48|0.8336
73935442|NCT03029208|147400356|SUPERIORITY||LS mean difference|-1.41||||0.9188|TWO_SIDED|95.0|-3.4|0.57|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||0.57|-3.40|0.9188
73935443|NCT03029208|147400356|SUPERIORITY||LS mean difference|-0.48||||0.6495|TWO_SIDED|95.0|-2.96|1.99|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.99|-2.96|0.6495
73972716|NCT03687762|147487339|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce a greater proportion of people decreasing their dose relative to those increasing their dose during treatment.|||||>|0.05|||||||Chi-squared|||||||>.05
73972717|NCT03687762|147487340|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972718|NCT03687762|147487341|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
74030486|NCT00696657|147615180|OTHER||Estimated treatment differences|0.08|||||TWO_SIDED|95.0|-0.22|0.37|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.37|-0.22|
73935444|NCT03029208|147400356|SUPERIORITY||LS mean difference|-0.27||||0.5737|TWO_SIDED|95.0|-3.09|2.56|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.56|-3.09|0.5737
73935445|NCT03029208|147400356|SUPERIORITY||LS mean difference|0.33||||0.3963|TWO_SIDED|95.0|-2.15|2.82|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||2.82|-2.15|0.3963
73935446|NCT03029208|147400356|SUPERIORITY||LS mean difference|0.62||||0.322|TWO_SIDED|95.0|-2.01|3.25|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||3.25|-2.01|0.3220
73935447|NCT03029208|147400356|SUPERIORITY||LS mean difference|0.53||||0.3485|TWO_SIDED|95.0|-2.13|3.18|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||3.18|-2.13|0.3485
73935448|NCT03029208|147400356|SUPERIORITY||LS mean difference|-1.49||||0.8064|TWO_SIDED|95.0|-4.87|1.9|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.90|-4.87|0.8064
73935449|NCT03029208|147400356|SUPERIORITY||LS mean difference|-1.29||||0.8687|TWO_SIDED|95.0|-3.57|0.98|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||0.98|-3.57|0.8687
73935450|NCT03029208|147400356|SUPERIORITY||LS mean difference|0.71||||0.2435|TWO_SIDED|95.0|-1.29|2.7|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.70|-1.29|0.2435
73935451|NCT03029208|147400356|SUPERIORITY||LS mean difference|-0.87||||0.7747|TWO_SIDED|95.0|-3.15|1.41|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.41|-3.15|0.7747
73935452|NCT03029208|147400356|SUPERIORITY||LS mean difference|-0.73||||0.7141|TWO_SIDED|95.0|-3.26|1.81|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.81|-3.26|0.7141
73972719|NCT03687762|147487342|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972720|NCT03687762|147487343|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972721|NCT03687762|147487344|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972722|NCT03687762|147487345|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73972723|NCT03687762|147487346|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
73866115|NCT04783077|147278384|SUPERIORITY||Odds Ratio (OR)|2.28||||0.23|TWO_SIDED|95.0|0.61|8.5|||Regression, Logistic||The estimated odds ratio of return donation attempt represents WhatsApp compared to control.|The primary analysis applies only to the RCT participants (N=130). Docudrama participants were not assessed for return blood donation. Analysis used fitted logistic regression with outcome donation attempted (Y/N) on the modiﬁed intention-to-treat (mITT) population, adjusted for type of donor (FRD, VNRBD).|Missing data on the primary outcome from the mITT analysis was handled using multiple imputation via chained equations with 50 imputations, and included stratum, group assignment (WhatsApp, Control) and ethnicity. Ethnicity was the only baseline variable with a minimum Kendall's tau of 0.2 with donation attempt.|8.50|0.61|0.23
73866116|NCT03045341|147278387|SUPERIORITY|Analyses used all available data.||||||0.0001|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||BWL versus no BWL||||0.0001
73866117|NCT03045341|147278387|SUPERIORITY|Analyses used all available data.||||||0.58|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||NB versus placebo||||0.58
73866118|NCT03045341|147278388|SUPERIORITY|Analyses used all available data.||||||0.0001|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||BWL versus no BWL||||0.0001
73972724|NCT04820322|147487354|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
73972725|NCT04820322|147487355|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
73972726|NCT04820322|147487356|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73972727|NCT04820322|147487357|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
73972728|NCT04820322|147487358|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
73972729|NCT04820322|147487359|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
73972730|NCT04820322|147487360|SUPERIORITY|||||||0.67|||||||Fisher Exact|||||||0.67
73972731|NCT04820322|147487361|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
73866119|NCT03045341|147278388|SUPERIORITY|Analyses used all available data.||||||0.63|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||NB versus placebo||||0.63
73866120|NCT03045341|147278389|SUPERIORITY|||||||0.004|||||||Chi-squared|||Analyses used all available data.||||.004
73866121|NCT00849862|147278407|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.0|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|85.0|
73866122|NCT00849862|147278408|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.0||||||90.0|96.3|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|96.3|
73866123|NCT00849862|147278409|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.6||||||90.0|96.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|96.2|
73866124|NCT01727336|147278410|OTHER||recommended dose for Part 2|0.9|||||TWO_SIDED||||||||The recommended dose level for Part 2 was determined to be 0.9 mg/kg|||||
73866125|NCT01424228|147278430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367|||||||Cochran-Mantel-Haenszel|||||||0.367
73866126|NCT03927404|147278462|OTHER|We used median (Inter-quartile range) to describe the continuous measures of limb health such as TEWL, Hydration, and Oxygenation levels at each visit and each location of the measurements in the sound (SL) and residual limbs (RL).|||||<|0.05||||||In a bivariate analysis, we used two-sided equality of the median test for the matched pairs of observations|bivariate analysis|||||||<0.05
73866127|NCT03927404|147278464|OTHER|We used median (Inter-quartile range) to describe the continuous measures of limb health such as TEWL, Hydration, and Oxygenation levels at each visit and each location of the measurements in the sound (SL) and residual limbs (RL).||||||0.05||||||In a bivariate analysis, we used two-sided equality of the median test for the matched pairs of observations|bivariate analysis|||||||0.05
73866128|NCT01229449|147278465|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73866129|NCT01229449|147278465|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73866130|NCT01229449|147278465|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
73866131|NCT01229449|147278465|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
73866132|NCT01229449|147278465|SUPERIORITY|||||||0.72|||||||ANOVA|||||||0.72
73866133|NCT01229449|147278465|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73972732|NCT04820322|147487362|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||||||0.023
73972733|NCT04820322|147487363|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
73972734|NCT04820322|147487364|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
73972735|NCT04200313|147487383|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972736|NCT04200313|147487383|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972737|NCT04200313|147487384|NON_INFERIORITY|Non-inferiority with a 1% non-inferiority margin|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972738|NCT04200313|147487384|NON_INFERIORITY|Non-inferiority with a 1% non-inferiority margin|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972739|NCT04200313|147487385|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972740|NCT04200313|147487385|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972741|NCT04200313|147487386|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972742|NCT04200313|147487386|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972743|NCT04200313|147487387|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972744|NCT04200313|147487387|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972745|NCT04200313|147487388|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972746|NCT04200313|147487388|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972747|NCT04200313|147487389|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972748|NCT04200313|147487389|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73935453|NCT03029208|147400356|SUPERIORITY||LS mean difference|-1.03||||0.7803|TWO_SIDED|95.0|-3.65|1.59|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.59|-3.65|0.7803
73935454|NCT03029208|147400356|SUPERIORITY||LS mean difference|-1.18||||0.8556|TWO_SIDED|95.0|-3.35|1.0|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||1.00|-3.35|0.8556
73935455|NCT03029208|147400356|SUPERIORITY||LS mean difference|0.08||||0.4763|TWO_SIDED|95.0|-2.61|2.77|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.77|-2.61|0.4763
73972749|NCT04200313|147487390|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
73972750|NCT04200313|147487390|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
73972751|NCT03580356|147487455|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|9.029|||<|0.0001|TWO_SIDED|95.0|3.183|25.615|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||25.615|3.183|<.0001
73972752|NCT03580356|147487455|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.926||||0.6646|TWO_SIDED|95.0|0.65|1.319|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.319|0.650|0.6646
73935456|NCT03029208|147400356|SUPERIORITY||LS mean difference|0.73||||0.3208|TWO_SIDED|95.0|-2.35|3.8|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||3.80|-2.35|0.3208
73972753|NCT03580356|147487455|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|11.508|||<|0.0001|TWO_SIDED|95.0|4.058|32.638|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||32.638|4.058|<.0001
73972754|NCT03580356|147487455|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio, log|1.181||||0.173|TWO_SIDED|95.0|0.836|1.667|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.667|0.836|0.1730
73972755|NCT03580356|147487456|SUPERIORITY||LS Mean|-9.997|STANDARD_ERROR_OF_MEAN|1.305|<|0.0001|TWO_SIDED|95.0|-12.554|-7.439|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||-7.439|-12.554|<.0001
73972756|NCT03580356|147487456|SUPERIORITY||LS mean|0.414|STANDARD_ERROR_OF_MEAN|0.922||0.6735|TWO_SIDED|95.0|-1.392|2.221|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||2.221|-1.392|0.6735
73972757|NCT03580356|147487456|SUPERIORITY||LS Mean|-11.091|STANDARD_ERROR_OF_MEAN|1.313|<|0.0001|TWO_SIDED|95.0|-13.664|-8.518|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||-8.518|-13.664|<.0001
73972758|NCT03580356|147487456|SUPERIORITY||LS mean|-0.68|STANDARD_ERROR_OF_MEAN|0.923||0.2305|TWO_SIDED|95.0|-2.489|1.128|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||1.128|-2.489|0.2305
73972759|NCT03580356|147487458|SUPERIORITY||LS Mean|-4.105|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-5.281|-2.929|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||-2.929|-5.281|<.0001
73972760|NCT03580356|147487458|SUPERIORITY||LS Mean|0.101|STANDARD_ERROR_OF_MEAN|0.422||0.5943|TWO_SIDED|95.0|-0.727|0.928|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||0.928|-0.727|0.5943
73972761|NCT03580356|147487458|SUPERIORITY|Adults only|LS Mean|-4.496|STANDARD_ERROR_OF_MEAN|0.603|<|0.0001|TWO_SIDED|95.0|-5.678|-3.314|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||||-3.314|-5.678|<.0001
73972762|NCT03580356|147487458|SUPERIORITY||LS Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.423||0.2467|TWO_SIDED|95.0|-1.12|0.54|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||0.540|-1.120|0.2467
73972763|NCT03580356|147487460|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|3.443|||<|0.0001|TWO_SIDED|95.0|1.955|6.063|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||6.063|1.955|<.0001
73935457|NCT03029208|147400357|SUPERIORITY||LS mean difference|-1.02||||0.791|TWO_SIDED|95.0|-3.5|1.46|||MMRM||SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.46|-3.50|0.7910
73935458|NCT03029208|147400357|SUPERIORITY||LS mean difference|-1.45||||0.8648|TWO_SIDED|95.0|-4.03|1.14|||MMRM||SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.14|-4.03|0.8648
73935459|NCT03029208|147400358|SUPERIORITY||LS mean difference|-0.28||||0.5879|TWO_SIDED|95.0|-2.75|2.19|||MMRM||SF-36 HRQoL physical functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.19|-2.75|0.5879
73972764|NCT03580356|147487460|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.838||||0.8524|TWO_SIDED|95.0|0.602|1.167|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.167|0.602|0.8524
73972765|NCT03580356|147487460|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|4.542|||<|0.0001|TWO_SIDED|95.0|2.577|8.004|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||8.004|2.577|<.0001
73972766|NCT03580356|147487460|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|1.106||||0.2764|TWO_SIDED|95.0|0.794|1.54|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.540|0.794|0.2764
73972767|NCT03580356|147487461|SUPERIORITY||Risk Ratio (RR)|1.389|||<|0.0001|TWO_SIDED|95.0|1.235|1.561|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.561|1.235|<.0001
73972768|NCT03580356|147487461|SUPERIORITY||Risk Ratio (RR)|1.029||||0.2369|TWO_SIDED|95.0|0.952|1.111|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.111|0.952|0.2369
73972769|NCT03580356|147487461|SUPERIORITY||Risk Ratio (RR)|1.425|||<|0.0001|TWO_SIDED|95.0|1.268|1.603|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.603|1.268|<.0001
73935460|NCT03029208|147400358|SUPERIORITY||LS mean difference|-1.43||||0.8525|TWO_SIDED|95.0|-4.12|1.26|||MMRM||SF-36 HRQoL physical functioning domain scor was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.26|-4.12|0.8525
73935461|NCT03029208|147400359|SUPERIORITY||LS mean difference|0.03||||0.3154|TWO_SIDED|95.0|-0.09|0.14|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.14|-0.09|0.3154
73935462|NCT03029208|147400360|SUPERIORITY||LS mean difference|-3.4||||0.7651|TWO_SIDED|95.0|-12.7|5.9|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||5.9|-12.7|0.7651
73935463|NCT03029208|147400361|SUPERIORITY||LS mean difference|-6.43||||0.9875|TWO_SIDED|95.0|-12.05|-0.82|||MMRM||Tired/Low energy/Weak domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||-0.82|-12.05|0.9875
73935464|NCT03029208|147400361|SUPERIORITY||LS mean difference|-4.11||||0.9663|TWO_SIDED|95.0|-8.52|0.3|||MMRM||Chest pain/Shortness of breath domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.30|-8.52|0.9663
73935465|NCT03029208|147400361|SUPERIORITY||LS mean difference|-6.6||||0.993|TWO_SIDED|95.0|-11.84|-1.35|||MMRM||Cognitive domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||-1.35|-11.84|0.9930
73972770|NCT03580356|147487461|SUPERIORITY||Risk Ratio (RR)|1.056||||0.083|TWO_SIDED|95.0|0.978|1.14|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.140|0.978|0.0830
73972771|NCT05715528|147487465|SUPERIORITY||Hazard Ratio (HR)|1.099||||0.0681|TWO_SIDED|95.0|0.997|1.211||P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Stratified Log-rank test||Hazard ratio and two-sided 95% confidence interval (CI) for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.211|0.997|0.0681
74030487|NCT00696657|147615180|OTHER||Estimated treatment differences|0.28|||||TWO_SIDED|95.0|-0.02|0.57|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.57|-0.02|
74030488|NCT00696657|147615180|OTHER||Estimated treatment differences|0.59|||||TWO_SIDED|95.0|0.31|0.88|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.88|0.31|
74030489|NCT00696657|147615180|OTHER||Estimated treatment differences|-0.68|||||TWO_SIDED|95.0|-0.97|-0.4|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Liraglutide 1.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.40|-0.97|
74030490|NCT04688346|147615258|NON_INFERIORITY|t-test|Mean Difference (Final Values)|1.0||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
74030491|NCT00059215|147615259|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||Fisher Exact|||||||0.933
74030492|NCT00059215|147615259|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Log Rank|||||||0.590
73866134|NCT01229449|147278465|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
73935466|NCT03029208|147400361|SUPERIORITY||LS mean difference|-3.03||||0.8765|TWO_SIDED|95.0|-8.19|2.12|||MMRM||Shortness of breath, no activity: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||2.12|-8.19|0.8765
73935467|NCT03029208|147400361|SUPERIORITY||LS mean difference|-4.27||||0.9464|TWO_SIDED|95.0|-9.48|0.94|||MMRM||Severity-short breath, Resting: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.94|-9.48|0.9464
73935468|NCT03029208|147400361|SUPERIORITY||LS mean difference|-5.31||||0.9101|TWO_SIDED|95.0|-13.09|2.47|||MMRM||Difficulty standing for long time: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||2.47|-13.09|0.9101
73935469|NCT03029208|147400361|SUPERIORITY||LS mean difference|-6.52||||0.9586|TWO_SIDED|95.0|-13.9|0.86|||MMRM||Difficulty sleeping: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.86|-13.90|0.9586
73935470|NCT03029208|147400362|SUPERIORITY||LS mean difference|0.27||||0.981|TWO_SIDED|95.0|0.02|0.53|||MMRM||MMRM model was fitted from Baseline up to Week 8 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.53|0.02|0.9810
73935471|NCT03029208|147400362|SUPERIORITY||LS mean difference|0.05||||0.6743|TWO_SIDED|95.0|-0.17|0.26|||MMRM||MMRM model was fitted from Baseline up to Week 12 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.26|-0.17|0.6743
73972772|NCT05715528|147487469|SUPERIORITY||Hazard Ratio (HR)|1.036||||0.5558|TWO_SIDED|95.0|0.935|1.147|||Stratified Log-Rank Test|P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.147|0.935|0.5558
73972773|NCT05715528|147487470|SUPERIORITY|||||||0.6469|||||||Fisher's exact test|||||||0.6469
74030493|NCT00059215|147615260|SUPERIORITY_OR_OTHER|||||||0.945||95.0|||||Fisher Exact|||||||0.945
74030494|NCT00059215|147615260|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Log Rank|||||||0.260
74030495|NCT00059215|147615261|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
73972774|NCT05715528|147487471|SUPERIORITY||Hazard Ratio (HR)|0.495||||0.5581|TWO_SIDED|95.0|0.045|5.464|||Log-rank test|P value was based on log-rank test.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression.|||5.464|0.045|0.5581
73972775|NCT05715528|147487473|SUPERIORITY||Least Squares Mean|0.02||||0.4254|TWO_SIDED|95.0|-0.03|0.08||p-value was from Mixed-effects model repeated measures (MMRM) with baseline viral load and randomization strata as covariates.|MMRM||95% CI was from MMRM with baseline viral load and randomization strata as covariates.|||0.08|-0.03|0.4254
74030496|NCT00059215|147615261|SUPERIORITY_OR_OTHER|||||||0.544||95.0|||||Log Rank|||||||0.544
73935472|NCT03029208|147400362|SUPERIORITY||LS mean difference|0.16||||0.8997|TWO_SIDED|95.0|-0.09|0.4|||MMRM||MMRM model was fitted from Baseline up to Week 28 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.40|-0.09|0.8997
73935473|NCT03029208|147400362|SUPERIORITY||LS mean difference|0.18||||0.8835|TWO_SIDED|95.0|-0.12|0.47|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.47|-0.12|0.8835
73935474|NCT01046643|147400406|SUPERIORITY_OR_OTHER|||||||0.222||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.222
73935475|NCT01046643|147400406|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.107
73935476|NCT01046643|147400406|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.127
73935477|NCT01046643|147400406|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.954
73935478|NCT01046643|147400406|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.385
73935479|NCT01046643|147400406|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.310
73972776|NCT05715528|147487474|SUPERIORITY||Hazard Ratio (HR)|1.138||||0.0015|TWO_SIDED|95.0|1.032|1.256||P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Stratified Log-rank test||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.256|1.032|0.0015
73935480|NCT01046643|147400407|SUPERIORITY_OR_OTHER|||||||0.594||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.594
73935481|NCT01046643|147400407|SUPERIORITY_OR_OTHER|||||||0.653||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.653
73935482|NCT01046643|147400408|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.452
73935483|NCT01046643|147400408|SUPERIORITY_OR_OTHER|||||||0.868||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.868
73935484|NCT01046643|147400408|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.549
73935485|NCT01046643|147400408|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.124
73935486|NCT01046643|147400408|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.158
73935487|NCT01046643|147400408|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.055
73935488|NCT01046643|147400409|SUPERIORITY_OR_OTHER|||||||0.561||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.561
73935489|NCT01046643|147400409|SUPERIORITY_OR_OTHER|||||||0.726||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.726
73935490|NCT04289753|147400441|SUPERIORITY||Odds Ratio (OR)|0.56|||||TWO_SIDED|95.0|0.46|0.69||||||||0.69|0.46|
73935491|NCT04289753|147400442|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
73935492|NCT04289753|147400443|SUPERIORITY||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.7|1.0||||||||1.0|0.70|
73935493|NCT05799495|147400481|OTHER||LS Mean difference|-0.671|STANDARD_ERROR_OF_MEAN|0.3178||0.0181|TWO_SIDED|80.0|-1.08|-0.262|||Mixed Models Analysis|||||-0.262|-1.080|0.0181
73935494|NCT05799495|147400481|OTHER||LS Mean difference|-0.802|STANDARD_ERROR_OF_MEAN|0.3562||0.0127|TWO_SIDED|80.0|-1.26|-0.344|||Mixed Models Analysis|||||-0.344|-1.260|0.0127
73935495|NCT05799495|147400481|OTHER||LS Mean difference|-1.167|STANDARD_ERROR_OF_MEAN|0.264|<|0.0001|TWO_SIDED|80.0|-1.506|-0.827|||Mixed Models Analysis|||||-0.827|-1.506|<.0001
73935496|NCT05799495|147400482|OTHER||LS Mean difference|-0.608|STANDARD_ERROR_OF_MEAN|0.3402||0.0378|TWO_SIDED|80.0|-1.046|-0.17|||Mixed Models Analysis|||Day 3||-0.170|-1.046|0.0378
73972777|NCT05715528|147487475|SUPERIORITY|||||||0.6978|||||||Fisher's exact test|P-value was from the Fisher's exact test.||||||0.6978
73972778|NCT05715528|147487480|SUPERIORITY|||||||0.5707|||||||Fisher's exact test|P-value was from the Fisher's exact test.||||||0.5707
74030497|NCT00059215|147615262|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Fisher Exact|||||||0.370
74030498|NCT04494633|147615266|SUPERIORITY|||||||0.482314|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, t-test with 61 degrees of freedom.||||||0.482314
74030499|NCT04494633|147615267|SUPERIORITY|||||||0.876964|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, t test with 61 degrees of freedom.||||||.876964
73935497|NCT05799495|147400482|OTHER||LS Mean difference|-1.304|STANDARD_ERROR_OF_MEAN|0.3718||0.0003|TWO_SIDED|80.0|-1.782|-0.826|||Mixed Models Analysis|||Day 3||-0.826|-1.782|0.0003
73935498|NCT05799495|147400482|OTHER||LS Mean difference|-1.148|STANDARD_ERROR_OF_MEAN|0.2803|<|0.0001|TWO_SIDED|80.0|-1.509|-0.788|||Mixed Models Analysis|||Day 3||-0.788|-1.509|<.0001
73935499|NCT05799495|147400482|OTHER||LS Mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.2732||0.5931|TWO_SIDED|80.0|-0.287|0.416|||Mixed Models Analysis|||Day 10||0.416|-0.287|0.5931
73935500|NCT05799495|147400482|OTHER||LS Mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.2914||0.508|TWO_SIDED|80.0|-0.369|0.381|||Mixed Models Analysis|||Day 10||0.381|-0.369|0.5080
73935501|NCT05799495|147400482|OTHER||LS Mean difference|-0.214|STANDARD_ERROR_OF_MEAN|0.223||0.1692|TWO_SIDED|80.0|-0.501|0.073|||Mixed Models Analysis|||Day 10||0.073|-0.501|0.1692
73935502|NCT05799495|147400482|OTHER||LS Mean difference|-0.239|STANDARD_ERROR_OF_MEAN|0.2004||0.1172|TWO_SIDED|80.0|-0.497|0.019|||Mixed Models Analysis|||Day 14||0.019|-0.497|0.1172
73935503|NCT05799495|147400482|OTHER||LS Mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.2178||0.3979|TWO_SIDED|80.0|-0.337|0.224|||Mixed Models Analysis|||Day 14||0.224|-0.337|0.3979
73935504|NCT05799495|147400482|OTHER||LS Mean difference|-0.383|STANDARD_ERROR_OF_MEAN|0.1655||0.0109|TWO_SIDED|80.0|-0.595|-0.17|||Mixed Models Analysis|||Day 14||-0.170|-0.595|0.0109
73935505|NCT04177108|147400507|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0098||95.0|0.28|0.85|||Log Rank|||||0.85|0.28|0.0098
73935506|NCT04177108|147400507|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.2396||95.0|0.42|1.25|||Log Rank|||||1.25|0.42|0.2396
73935507|NCT04177108|147400507|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9809||95.0|0.63|1.58|||Log Rank|||||1.58|0.63|0.9809
73935508|NCT04177108|147400508|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6805||95.0|0.55|2.51|||Log Rank|||||2.51|0.55|0.6805
73935509|NCT04177108|147400508|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.6314||95.0|0.55|2.64|||Log Rank|||||2.64|0.55|0.6314
73935510|NCT04177108|147400508|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9164||95.0|0.52|2.06|||Log Rank|||||2.06|0.52|0.9164
73935511|NCT04433767|147400584|OTHER||Slope|-1.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age and gender.||||||< 0.001
73935512|NCT04433767|147400586|OTHER||Intercept|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0127|TWO_SIDED|95.0|0.04|0.32|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.32|0.04|0.0127
73935513|NCT04433767|147400587|OTHER||Intercept|0.34|STANDARD_ERROR_OF_MEAN|0.08||0.0005|TWO_SIDED|95.0|0.17|0.51|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.51|0.17|0.0005
73935514|NCT04433767|147400588|OTHER||Intercept|0.19|STANDARD_ERROR_OF_MEAN|0.11||0.1027|TWO_SIDED|95.0|-0.04|0.42|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.42|-0.04|0.1027
73935515|NCT04433767|147400589|OTHER||Intercept|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4846|TWO_SIDED|95.0|-0.18|0.37|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.37|-0.18|0.4846
73935516|NCT04433767|147400590|OTHER||Intercept|9.04|STANDARD_ERROR_OF_MEAN|25.77||0.729|TWO_SIDED|95.0|-44.28|62.36|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||62.36|-44.28|0.7290
73935517|NCT04433767|147400591|OTHER||Intercept|-0.25|STANDARD_ERROR_OF_MEAN|2.43||0.9196|TWO_SIDED|95.0|-5.28|4.78|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||4.78|-5.28|0.9196
73935518|NCT04433767|147400592|OTHER||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.033|TWO_SIDED|95.0|0.01|0.33|||Mixed Models Analysis|Adjusted for age and gender.||||0.33|0.01|0.033
73935519|NCT04433767|147400593|OTHER||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.09||0.041|TWO_SIDED|95.0|0.01|0.35|||Mixed Models Analysis|Adjusted for age and gender.||||0.35|0.01|0.041
73935520|NCT04433767|147400594|OTHER||Slope|-11.13|STANDARD_ERROR_OF_MEAN|3.36||0.001|TWO_SIDED|95.0|-17.81|-4.45|||Mixed Models Analysis|Adjusted for age and gender.||||-4.45|-17.81|0.001
73935521|NCT04433767|147400595|OTHER||Slope|-12.64|STANDARD_ERROR_OF_MEAN|3.68||0.001|TWO_SIDED|95.0|-19.94|-5.33|||Mixed Models Analysis|Adjusted for age and gender.||||-5.33|-19.94|0.001
73935522|NCT04433767|147400596|OTHER||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.15|-0.32|||Mixed Models Analysis|||||-0.32|-1.15|<0.001
73935523|NCT04433767|147400597|OTHER||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.92|-0.34|||Mixed Models Analysis|Adjusted for age and gender.||||-0.34|-0.92|0.001
73935524|NCT04433767|147400598|OTHER||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.65|-0.18|||Mixed Models Analysis|Adjusted for age and gender.||||-0.18|-0.65|<0.001
73935525|NCT04433767|147400599|OTHER||Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.35||0.183|TWO_SIDED|95.0|-1.17|0.23|||Mixed Models Analysis|Adjusted for age and gender.||||0.23|-1.17|0.183
73935526|NCT04433767|147400600|OTHER||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.17|TWO_SIDED|95.0|-0.74|0.13|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.13|-0.74|0.170
73935527|NCT04433767|147400601|OTHER||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.051|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.80|0.00|0.051
73935528|NCT04433767|147400602|OTHER||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.33|-0.11|||Mixed Models Analysis|Analyses adjusted for age and gender.||||-0.11|-0.33|<0.001
73972779|NCT03536884|147487481|NON_INFERIORITY|The evaluation of noninferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a noninferiority margin of 10%.|Risk Difference (RD)|12.682|||||TWO_SIDED|95.0|5.771|19.592||||||Risk Difference: BKZ-Secukinumab calculated using stratified Cochran-Mantel-Haenszel (CMH).||19.592|5.771|
73972780|NCT03536884|147487481|SUPERIORITY||Odds Ratio (OR)|1.714|||<|0.001|TWO_SIDED|95.0|1.271|2.31||P-values for the comparison of treatment groups are based on the CMH test for the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||2.310|1.271|<0.001
73972781|NCT03536884|147487482|SUPERIORITY||Odds Ratio (OR)|2.817|||<|0.001|TWO_SIDED|95.0|2.068|3.836||P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.836|2.068|<0.001
73972782|NCT03536884|147487484|SUPERIORITY||Odds Ratio (OR)|2.49|||<|0.001|TWO_SIDED|95.0|1.835|3.377||P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.377|1.835|<0.001
73972783|NCT03536884|147487484|SUPERIORITY||Odds Ratio (OR)|2.168|||<|0.001|TWO_SIDED|95.0|1.511|3.11||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.110|1.511|<0.001
73866135|NCT01229449|147278465|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
73935529|NCT04433767|147400603|OTHER||Slope|0.43|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED|95.0|0.17|0.69|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.69|0.17|0.002
73935530|NCT04433767|147400604|OTHER||Slope|0.52|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED|95.0|0.21|0.83|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.83|0.21|0.002
73935531|NCT04433767|147400605|OTHER||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.55||0.876|TWO_SIDED|95.0|-1.05|1.23|||Mixed Models Analysis|Analyses adjusted for age and gender.||||1.23|-1.05|0.876
73935532|NCT00298233|147400606|SUPERIORITY_OR_OTHER|||||||0.42||||||Significance assessed at the 5% level for a two-sided comparison|conditional univariate logistic regressi|analysis stratified by study site||Based on previous studies, assumption was made that 30% of children and 55% of adults treated with standard dose oseltamivir would test negative for virus on day five. This would require a sample size of 242 patients to show a 20% absolute improvement in cessation of viral shedding with 85% power and a two sided α of 0.05. To allow for study withdrawals, the target sample size was set at 300 patients.||||0.42
73935533|NCT00298233|147400607|SUPERIORITY_OR_OTHER|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel|||||||0.54
73935534|NCT00298233|147400608|SUPERIORITY_OR_OTHER|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel|Mantel-Haenszel chi-square stratified by study site||||||0.54
73935535|NCT00298233|147400609|SUPERIORITY_OR_OTHER|||||||0.48||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.48
73935536|NCT00298233|147400610|SUPERIORITY_OR_OTHER|||||||0.66||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.66
73935537|NCT00298233|147400611|SUPERIORITY_OR_OTHER|||||||0.58||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.58
73935538|NCT02371369|147400612|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
73935539|NCT02371369|147400613|OTHER|Treatment comparison analysis||||||0.0043|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||0.0043
73935540|NCT02371369|147400614|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
73935541|NCT02371369|147400615|OTHER|Treatment comparison analysis||||||0.0019|||||||Mixed effects model for repeated measure|||Treatment comparison between pexidartinib and placebo groups at Week 25||||0.0019
73935542|NCT02371369|147400616|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Mixed effects model for repeated measure|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
73935543|NCT00439777|147400629|NON_INFERIORITY_OR_EQUIVALENCE|Assuming equal efficacy, a total of 88 events will give a power of 90% to demonstrate that rivaroxaban is at least as effective as the comparator, considering a relative non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided alpha=0.05). The mean overall incidence for the primary efficacy outcome of 3% was expected and therefore 1465 patients per group would be needed. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|1.12|STANDARD_ERROR_OF_MEAN|0.2067||0.0026|TWO_SIDED|95.0|0.75|1.68|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.||1.68|0.75|0.0026
73935544|NCT00439777|147400630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.15||0.33|TWO_SIDED|95.0|0.86|1.56||Nominal p-value|Regression, Cox||The standard error of the log hazard ratio was estimated.|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.||1.56|0.86|0.33
73935545|NCT00439777|147400631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|STANDARD_ERROR_OF_MEAN|0.1499||0.275|TWO_SIDED|95.0|0.63|1.14||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|||1.14|0.63|0.275
73935546|NCT00439777|147400632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.257||0.55|TWO_SIDED|95.0|0.7|1.93||nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.93|0.70|0.55
73935547|NCT00439777|147400633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|STANDARD_ERROR_OF_MEAN|0.3289||0.85|TWO_SIDED|95.0|0.49|1.79||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.79|0.49|0.85
73935548|NCT00439777|147400634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|STANDARD_ERROR_OF_MEAN|0.08756||0.23|TWO_SIDED|95.0|0.76|1.07||If the primary efficacy analysis shows that rivaroxaban is non-inferior to the comparator, the principal safety outcome was to be compared between treatment groups to maintain the overall type I error of 0.05 (2-sided) (a closed testing procedure).|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.07|0.76|0.23
73935549|NCT03855189|147400658|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935550|NCT03855189|147400658|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.||||<0.01
73935551|NCT03855189|147400658|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.||||0.06
73935552|NCT03855189|147400659|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
73935553|NCT03855189|147400659|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
73935554|NCT03855189|147400659|OTHER|||||||0.5|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.50
73935555|NCT03855189|147400662|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935556|NCT03855189|147400662|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935557|NCT03855189|147400662|OTHER|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.11
73935558|NCT03855189|147400663|OTHER|||||||0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.05
73935559|NCT03855189|147400663|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935560|NCT03855189|147400663|OTHER|||||||0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.13
73866136|NCT01229449|147278465|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73866137|NCT01229449|147278465|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73866138|NCT00377364|147278476|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Baseline RAVLT scores used as covariate.||||<0.05
73866139|NCT00377364|147278479|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|Baseline ISS scores used as a covariate. ANCOVA results were not significant.||||||<0.05
73866140|NCT00377364|147278480|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Baseline HRSD scores used as a covariate.||||<0.05
73866141|NCT00377364|147278482|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|Baseline YMRS scores used as a covariate.||||||0.05
73866142|NCT00377364|147278484|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|Baseline ACQ scores used as a covariate.||||||<0.05
73866143|NCT02533726|147278486|SUPERIORITY||Odds Ratio (OR)|0.27||||0.012|TWO_SIDED|95.0|0.1|0.75|||Fisher Exact|||Per-protocol (PP) analysis, consistent with regulatory guidance (FDA).||.75|.1|.012
73935561|NCT03855189|147400664|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.06
73935562|NCT03855189|147400664|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
73935563|NCT03855189|147400664|OTHER|||||||0.81|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.81
73935564|NCT03855189|147400665|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
73935565|NCT03855189|147400665|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935566|NCT03855189|147400665|OTHER|||||||0.17|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.17
73935567|NCT03855189|147400666|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935568|NCT03855189|147400666|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
73935569|NCT03855189|147400666|OTHER|||||||0.39|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.39
73935570|NCT03855189|147400667|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73866144|NCT02533726|147278486|OTHER||Odds Ratio (OR)|0.2||||0.015|TWO_SIDED|95.0|0.06|0.74|||Fisher Exact|||Per protocol analysis adjusted for admitting team, unit of admission, and risk for pressure injury.||0.74|0.06|0.015
73866145|NCT03596450|147278490|SUPERIORITY||Treatment effect|1.36||||0.033|TWO_SIDED|95.0|1.03|1.79|||Regression, Logistic|||Estimate and p-value are based on logistic regression model with logit link function, treatment as categorical effect, and baseline HbA1c as covariate.||1.79|1.03|0.033
73866146|NCT04484207|147278559|SUPERIORITY|||||||0.031|||||||GEE|||||||0.031
73935571|NCT03855189|147400667|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935572|NCT03855189|147400667|OTHER|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.60
73935573|NCT03855189|147400668|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
73935574|NCT03855189|147400668|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
73935575|NCT03855189|147400668|OTHER|||||||0.54|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.54
73935576|NCT03855189|147400669|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935577|NCT03855189|147400669|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
73935578|NCT03855189|147400669|OTHER|||||||0.71|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.71
73935579|NCT03855189|147400670|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935580|NCT03855189|147400670|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935581|NCT03855189|147400670|OTHER|||||||0.77|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.77
73866147|NCT04836247|147278567|SUPERIORITY||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
73866148|NCT04836247|147278568|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
73866149|NCT04836247|147278569|SUPERIORITY||Mean Difference (Final Values)|2.61|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
73866150|NCT04836247|147278570|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.74|TWO_SIDED||||||t-test, 2 sided|||||||0.74
73866151|NCT04836247|147278571|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.76|TWO_SIDED||||||t-test, 2 sided|||||||0.76
73866152|NCT04836247|147278572|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
73935582|NCT03855189|147400671|OTHER|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.11
73935583|NCT03855189|147400671|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
73935584|NCT03855189|147400671|OTHER|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.60
73935585|NCT03855189|147400672|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935586|NCT03855189|147400672|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935587|NCT03855189|147400672|OTHER|||||||0.59|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.59
73935588|NCT03855189|147400673|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
73935589|NCT03855189|147400673|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
73935590|NCT03855189|147400673|OTHER|||||||0.43|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.43
73935591|NCT03855189|147400674|OTHER|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.09
73935592|NCT03855189|147400674|OTHER|||||||0.08|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.08
73972784|NCT03536884|147487484|SUPERIORITY||Odds Ratio (OR)|3.243|||<|0.001|TWO_SIDED|95.0|2.103|5.0||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||5.000|2.103|<0.001
73972785|NCT04204083|147487547|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
73972786|NCT04204083|147487548|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
73972787|NCT04204083|147487549|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
74030500|NCT04494633|147615268|SUPERIORITY|||||||0.66602|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, with 61 degrees of freedom.||||||.66602
73935593|NCT03855189|147400674|OTHER|||||||0.96|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.96
73935594|NCT03855189|147400675|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
73935595|NCT03855189|147400675|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935596|NCT03855189|147400675|OTHER|||||||0.64|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.64
73935597|NCT03855189|147400676|OTHER|||||||0.25|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.25
73972788|NCT04934072|147487581|NON_INFERIORITY|Non-inferiority of FKS518 to US-Prolia was demonstrated if the 90% CI for the difference in mean percent change from baseline to Week 52 in LS-BMD laid entirely above -1.45%.|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|90.0|-0.05|0.96|||||Difference : FKS518 - US-Prolia|||0.96|-0.05|
73935598|NCT03855189|147400676|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
73935599|NCT03855189|147400676|OTHER|||||||0.26|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.26
73935600|NCT03855189|147400677|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935601|NCT03855189|147400677|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935602|NCT03855189|147400677|OTHER|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.09
73935603|NCT03855189|147400678|OTHER|||||||0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.05
73935604|NCT03855189|147400678|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935605|NCT03855189|147400678|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
73935606|NCT03855189|147400679|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
73935607|NCT03855189|147400679|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
73935608|NCT03855189|147400679|OTHER|||||||0.53|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.53
73935609|NCT03855189|147400680|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
73972789|NCT04934072|147487581|OTHER|Non-superiority Analysis: Non-superiority of FKS518 to US-Prolia was demonstrated if the 90% CI for the difference in mean percent change from baseline to Week 52 in LS-BMD laid entirely below 1.45%.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|90.0|0.19|1.2|||||Difference : FKS518 - US-Prolia|||1.20|0.19|
73972790|NCT05736458|147487608|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.66|TWO_SIDED||||||t-test, 2 sided|||Of the 23 participants who completed all study procedures, 2 participant's data was unusable for this analysis. Statistics are from paired 2 tailed t-test comparing pre-rTMS 2-back percent accuracy scores for participant's high and low controllability target.||||0.66
73972791|NCT05736458|147487609|SUPERIORITY||Mean Difference (Final Values)|1.94||||0.43|TWO_SIDED||||||t-test, 2 sided|df = 19||Statistics are from 2-tailed t-test comparing pre-rTMS to post-rTMS 2-back accuracy scores for a high controllability TMS target. Alternative hypothesis: true mean is not equal to 0.||||0.43
73972792|NCT05736458|147487609|SUPERIORITY||Mean Difference (Final Values)|6.36|||<|0.04|TWO_SIDED||||||t-test, 2 sided|df = 20||Statistics are from 2-tailed t-test comparing pre-rTMS and post-rTMS 2-back percent accuracy scores for a low controllability TMS target. Alternative hypothesis: true mean is not equal to 0.||||<0.04
73935610|NCT03855189|147400680|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935611|NCT03855189|147400680|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
73935612|NCT03855189|147400681|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
73935613|NCT03855189|147400681|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73972793|NCT05736458|147487610|SUPERIORITY||Mean Difference (Final Values)|11.54|||<|0.05|TWO_SIDED||||||t-test, 2 sided|df = 11||Statistics are from 2-tailed paired t-test comparing 2-back accuracy score before and after rTMS to a high controllability target. Alternative hypothesis: true mean is not equal to 0.||||<0.05
74030501|NCT04494633|147615269|SUPERIORITY|||||||0.726421|||||||t-test, 2 sided|Two-tailed unpaired t test comparing change for control (Pre to 2 weeks later) to case (Pre- to 2 weeks post) with 61 degrees of freedom.||||||.726421
73935614|NCT03855189|147400681|OTHER|||||||0.34|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.34
73866153|NCT02100475|147278585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.427|TWO_SIDED|95.0|-1.05|0.46|||ANCOVA|||The response and change from baseline in the response after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) method with treatment and baseline IDegLira dose strata as fixed factors and baseline response as a covariate. Missing data were imputed using LOCF.||0.46|-1.05|0.427
73935615|NCT03855189|147400682|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935616|NCT03855189|147400682|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935617|NCT03855189|147400682|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
73935618|NCT03855189|147400683|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.06
73935619|NCT03855189|147400683|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73972794|NCT05736458|147487611|SUPERIORITY||Mean Difference (Net)|-4.42||||0.27|TWO_SIDED||||||t-test, 2 sided|df = 19||Statistics are from paired 2 tailed t-test comparing 2-back percent changes (Post-rTMS - pre-rTMS) scores for participant's high and low controllability target. Alternative hypothesis: true mean is not equal to 0.||||0.27
73972795|NCT02865538|147487678|OTHER|Descriptive Analysis|LS means difference|0.09|STANDARD_ERROR_OF_MEAN|0.127||0.4641|TWO_SIDED|90.0|-0.12|0.3|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.30|-0.12|0.4641
73972796|NCT02865538|147487678|OTHER|Descriptive Analysis|Linear mixed-effects model|0.0|STANDARD_ERROR_OF_MEAN|0.128||0.9894|TWO_SIDED|90.0|-0.21|0.21|||LS means difference||Change from Week -1 to Week 1|||0.21|-0.21|0.9894
73972797|NCT02865538|147487678|OTHER|Descriptive Analysis|LS means difference|-0.31|STANDARD_ERROR_OF_MEAN|0.129||0.0199|TWO_SIDED|90.0|-0.52|-0.09|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.09|-0.52|0.0199
73972798|NCT02865538|147487678|OTHER|Descriptive Analysis|LS means difference|-0.12|STANDARD_ERROR_OF_MEAN|0.133||0.3907|TWO_SIDED|90.0|-0.34|0.11|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.11|-0.34|0.3907
73972799|NCT02865538|147487678|OTHER|Descriptive Analysis|LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.166||0.5393|TWO_SIDED|90.0|-0.17|0.38|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.38|-0.17|0.5393
73972800|NCT02865538|147487678|OTHER|Descriptive Analysis|LS means difference|-0.04|STANDARD_ERROR_OF_MEAN|0.169||0.7931|TWO_SIDED|90.0|-0.33|0.24|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.24|-0.33|0.7931
73972801|NCT02865538|147487678|OTHER|Descriptive Analysis|LS means difference|-0.63|STANDARD_ERROR_OF_MEAN|0.169||0.0004|TWO_SIDED|90.0|-0.92|-0.35|||Linear mixed-effects model||Change from Week -1 to Week 2|||-0.35|-0.92|0.0004
73972802|NCT02865538|147487678|OTHER|Descriptive Analysis|LS means difference|-0.16|STANDARD_ERROR_OF_MEAN|0.175||0.3739|TWO_SIDED|90.0|-0.45|0.13|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.13|-0.45|0.3739
74030502|NCT04494633|147615270|SUPERIORITY|||||||0.908468|||||||t-test, 2 sided|The statistical test used was a 2 tailed, unpaired t test with 61 degrees of freedom.||||||0.908468
73935620|NCT03855189|147400683|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
73935621|NCT03855189|147400684|OTHER|||||||0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.13
73935622|NCT03855189|147400684|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935623|NCT03855189|147400684|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
73935624|NCT03855189|147400685|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
73935625|NCT03855189|147400685|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
73935626|NCT03855189|147400685|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
73972803|NCT02865538|147487679|OTHER|Descriptive Analysis|LS means difference|5.29|STANDARD_ERROR_OF_MEAN|3.077||0.09|TWO_SIDED|90.0|0.16|10.42|||Linear mixed-effects model||Change from Week -1 to Week 1|||10.42|0.16|0.0900
73972804|NCT02865538|147487679|OTHER|Descriptive Analysis|LS means difference|-4.46|STANDARD_ERROR_OF_MEAN|3.053||0.1487|TWO_SIDED|90.0|-9.55|0.63|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.63|-9.55|0.1487
73972805|NCT02865538|147487679|OTHER|Descriptive Analysis|LS means difference|-10.18|STANDARD_ERROR_OF_MEAN|3.015||0.0012|TWO_SIDED|90.0|-15.2|-5.15|||Linear mixed-effects model||Change from Week -1 to Week 1|||-5.15|-15.20|0.0012
73972806|NCT02865538|147487679|OTHER|Descriptive Analysis|LS means difference|-6.14|STANDARD_ERROR_OF_MEAN|3.142||0.0548|TWO_SIDED|90.0|-11.37|-0.9|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.90|-11.37|0.0548
73972807|NCT02865538|147487679|OTHER|Descriptive Analysis|LS means difference|6.59|STANDARD_ERROR_OF_MEAN|3.337||0.0522|TWO_SIDED|90.0|1.03|12.15|||Linear mixed-effects model||Change from Week -1 to Week 2|||12.15|1.03|0.0522
73972808|NCT02865538|147487679|OTHER|Descriptive Analysis|LS means difference|-5.07|STANDARD_ERROR_OF_MEAN|3.329||0.1326|TWO_SIDED|90.0|-10.61|0.48|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.48|-10.61|0.1326
73972809|NCT02865538|147487679|OTHER|Descriptive Analysis|LS means difference|-12.28|STANDARD_ERROR_OF_MEAN|3.27||0.0004|TWO_SIDED|90.0|-17.73|-6.83|||Linear mixed-effects model||Change from Week -1 to Week 2|||-6.83|-17.73|0.0004
73972810|NCT02865538|147487679|OTHER|Descriptive Analysis|LS means difference|-7.79|STANDARD_ERROR_OF_MEAN|3.408||0.0253|TWO_SIDED|90.0|-13.47|-2.11|||Linear mixed-effects model||Change from Week -1 to Week 2|||-2.11|-13.47|0.0253
73972811|NCT02865538|147487680|OTHER|Descriptive Analysis|LS means difference|1.4|STANDARD_ERROR_OF_MEAN|1.58||0.3796|TWO_SIDED|90.0|-1.2|4.0|||Linear mixed-effects model||Day 7 Change from Day -1|||4.0|-1.2|0.3796
73972812|NCT02865538|147487680|OTHER|Descriptive Analysis|LS means difference|-2.3|STANDARD_ERROR_OF_MEAN|1.55||0.1413|TWO_SIDED|90.0|-4.9|0.3|||Linear mixed-effects model||Day 7 Change from Day -1|||0.3|-4.9|0.1413
74030503|NCT04494633|147615271|SUPERIORITY|||||||0.468104|||||||t-test, 2 sided|The groups were compared using a two tailed unpaired t test with 61 degrees of freedom.||||||.468104
74030504|NCT00390780|147615279|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025|one-sided test|||"Analyses for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|||-0.15|>0.025
74030505|NCT00390780|147615280|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|one-sided noninferiority test|||"Analysis for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|||-0.15|>0.025
74030506|NCT00390780|147615281|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.0974|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.0974
73935627|NCT04307186|147400708|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."|||||<|0.0001||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 1||||<0.0001
73935628|NCT04307186|147400708|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."||||||0.5775||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 2||||0.5775
73935629|NCT04307186|147400708|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."||||||0.3173||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 3||||0.3173
73935630|NCT04307186|147400709|NON_INFERIORITY|The non-inferiority of gadoquatrane versus gadobutrol was evaluated using CIs based on the t-distribution. A non-inferiority margin of 1 was used, i.e. meaning that a 95% two-sided CI for the mean difference gadoquatrane minus gadobutrol score must exclude the value -1.|Mean Difference (Final Values)|-0.05|||<|0.0001|TWO_SIDED|95.0|-0.24|0.13||P-Value was calculated. Non-inferiority was achieved with a one-sided p-value lower than 0.025.|t-test, 1 sided|||Average reader||0.13|-0.24|<0.0001
73935631|NCT04307186|147400710|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|1.06|1.34|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.34|1.06|
74030507|NCT00390780|147615281|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|Compare proportion of clinical success|0.15||||0.1115|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.1115
74039410|NCT04847141|147632414|SUPERIORITY||LS Mean Difference|0.03||||0.0692|TWO_SIDED|95.0|0.0|0.07||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.07|-0.00|0.0692
73935632|NCT04307186|147400710|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.94|1.25|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.25|0.94|
73935633|NCT04307186|147400711|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|2.07|||||TWO_SIDED|95.0|1.87|2.28|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||2.28|1.87|
73935634|NCT04307186|147400711|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|2.06|||||TWO_SIDED|95.0|1.86|2.25|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||2.25|1.86|
73935635|NCT04307186|147400712|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.27|||||TWO_SIDED|95.0|1.11|1.43|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.43|1.11|
73935636|NCT04307186|147400712|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|1.05|1.32|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.32|1.05|
73935637|NCT01175226|147400714|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.020
73935638|NCT02854540|147400716|OTHER||Mean difference (percent)|59.0|STANDARD_DEVIATION|16.0|||TWO_SIDED|||||||||||||
73935639|NCT00754845|147400719|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.91|||Log Rank|Stratified by the stratification factors at randomization||||0.91|0.48|0.01
73935640|NCT00754845|147400720|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
73935641|NCT00754845|147400721|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.83|TWO_SIDED|95.0|0.73|1.28|||Log Rank|||||1.28|0.73|0.83
73935642|NCT00754845|147400722|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
73935643|NCT03238001|147400734|NON_INFERIORITY|In order to show non-inferiority, a lower 90% confidence limit (CL) for the difference in kappa scores would need to be greater than or equal to -0.20. The 90% confidence interval was calculated based on 5000 bootstrapped differences in kappa scores.|Lower 90% CL for difference in Kappas|-0.12|||||TWO_SIDED|90.0|-0.12|0.05|||||90% CI for Kappa of DCTclock/MoCA - Kappa of MMSE/MoCA (estimated with bootstrap method using 5000 bootstraps).|A two-one-sided tests approach was taken, where, prior to analysis, it was determined that a delta (equivalence margin) of 0.20 would be considered a significant difference between the DCTclock/MoCA kappa and the MMSE/MoCA kappa. The reasoning behind this determination can be found in the study's statistical analysis plan.||0.05|-0.12|
73935644|NCT01827904|147400756|SUPERIORITY|Percent change from Baseline at the 3 Month visit in the Exablate test vs. Sham control arms was tested using the t-test.|||||<|0.001|||||||t-test, 1 sided|alpha = 0.05 for the hypothesis test. H0: M3ExAblate ≤ M3Sham H1: M3ExAblate \> M3Sham||"Note that the Crossover group was a rescue treatment group and not integral to the experimental design statistical analysis."||||<0.001
73935645|NCT03191903|147400772|SUPERIORITY|||||||0.5874|||||||ANOVA|||||||0.5874
73935646|NCT03191903|147400773|SUPERIORITY|||||||0.0829|||||||ANOVA|||||||0.0829
73935647|NCT03191903|147400774|SUPERIORITY|||||||0.4673|||||||ANOVA|||||||0.4673
74030508|NCT00390780|147615282|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.8787|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.8787
73935648|NCT03191903|147400775|SUPERIORITY|||||||0.9408|||||||ANOVA|||||||0.9408
73935649|NCT03191903|147400776|SUPERIORITY|||||||0.777|||||||ANOVA|||||||0.7770
73935650|NCT03191903|147400777|SUPERIORITY|||||||0.759|||||||ANOVA|||||||0.7590
73935651|NCT03191903|147400778|SUPERIORITY|||||||0.8309|||||||ANOVA|||||||0.8309
73935652|NCT03191903|147400779|SUPERIORITY|||||||0.6215|||||||ANOVA|||||||0.6215
73935653|NCT03191903|147400780|SUPERIORITY|||||||0.216|||||||ANOVA|||||||0.2160
73935654|NCT03191903|147400781|SUPERIORITY|||||||0.7026|||||||ANOVA|||||||0.7026
73935655|NCT03191903|147400782|SUPERIORITY|||||||0.0438|||||||ANOVA|||||||0.0438
73935656|NCT02897141|147400809|SUPERIORITY||Mean Difference (Final Values)|-0.541|STANDARD_ERROR_OF_MEAN|0.156||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety||||0.001
73935657|NCT02897141|147400809|SUPERIORITY||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.161||0.356|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count; a=0.05|Mixed Models Analysis|||Cough or Shortness of Breath||||0.356
73935658|NCT02897141|147400809|SUPERIORITY||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.163||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression||||0.001
73935659|NCT02897141|147400809|SUPERIORITY||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.141||0.962|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Diarrhea||||0.962
73935660|NCT02897141|147400809|SUPERIORITY||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.162||0.651|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Difficulty falling or staying asleep||||0.651
73935661|NCT02897141|147400809|SUPERIORITY|Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.145||0.23|TWO_SIDED||||||Mixed Models Analysis|||Difficulty remembering||||0.230
73935662|NCT02897141|147400809|SUPERIORITY||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|0.126||0.275|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Dizziness||||0.275
73935663|NCT02897141|147400809|SUPERIORITY||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.175||0.987|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue||||0.987
73935664|NCT02897141|147400809|SUPERIORITY||Mean Difference (Net)|-0.275|STANDARD_ERROR_OF_MEAN|0.132||0.037|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fever, chills, sweats||||0.037
73935665|NCT02897141|147400809|SUPERIORITY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.101||0.534|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Nausea or vomiting||||0.534
73935666|NCT02897141|147400809|SUPERIORITY||Mean Difference (Final Values)|-0.485|STANDARD_ERROR_OF_MEAN|0.157||0.002|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Neuropathy||||0.002
73935667|NCT02897141|147400809|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.139||0.349|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Skin problems||||0.349
73935668|NCT02897141|147400809|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.107||0.02|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Weight loss or wasting||||0.020
73935669|NCT02897141|147400810|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|7.27||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Physical functioning scale||||0.001
73935670|NCT02897141|147400810|SUPERIORITY|\[Not specified\]|Median Difference (Final Values)|7.47|STANDARD_ERROR_OF_MEAN|10.02||0.458|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Role limitations due to physical health scale||||0.458
73935671|NCT02897141|147400810|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|9.91||0.725|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Role limitations due to emotional problems scale||||0.725
73866154|NCT00649428|147278588|SUPERIORITY_OR_OTHER|||||||1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||.00001
73935672|NCT02897141|147400810|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.09||0.807|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Energy/fatigue scale|\[Not specified\]|||0.807
73935673|NCT02897141|147400810|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|3.73||0.693|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Emotional well-being scale||||0.693
73935674|NCT02897141|147400810|SUPERIORITY||Mean Difference (Final Values)|-8.93|STANDARD_ERROR_OF_MEAN|5.8||0.128|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Social functioning scale||||0.128
73972813|NCT02865538|147487680|OTHER|Descriptive Analysis|LS means difference|-5.5|STANDARD_ERROR_OF_MEAN|1.55||0.0007|TWO_SIDED|90.0|-8.1|-2.9|||Linear mixed-effects model||Day 7 Change from Day -1|||-2.9|-8.1|0.0007
73972814|NCT02865538|147487680|OTHER|Descriptive Analysis|LS means difference|-3.1|STANDARD_ERROR_OF_MEAN|1.62||0.0624|TWO_SIDED|90.0|-5.8|-0.4|||Linear mixed-effects model||Day 7 Change from Day -1|||-0.4|-5.8|0.0624
73972815|NCT02865538|147487680|OTHER|Descriptive Analysis|LS means difference|1.3|STANDARD_ERROR_OF_MEAN|1.21||0.293|TWO_SIDED|90.0|-0.7|3.3|||Linear mixed-effects model||Day 14 Change from Day -1|||3.3|-0.7|0.2930
73972816|NCT02865538|147487680|OTHER|Descriptive Analysis|LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.21||0.0512|TWO_SIDED|90.0|-4.4|-0.4|||Linear mixed-effects model||Day 14 Change from Day -1|||-0.4|-4.4|0.0512
73972817|NCT02865538|147487680|OTHER|Descriptive Analysis|LS means difference|-5.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|90.0|-7.0|-3.0|||Linear mixed-effects model||Day 14 Change from Day -1|||-3.0|-7.0|<0.0001
73935675|NCT02897141|147400810|SUPERIORITY||Mean Difference (Final Values)|-14.33|STANDARD_ERROR_OF_MEAN|5.18||0.007|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain scale||||0.007
73935676|NCT02897141|147400810|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|3.93||0.96|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||General health scale||||0.960
73935677|NCT02897141|147400810|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|4.47||0.836|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical health summary scale||||0.836
73935678|NCT02897141|147400810|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|3.6||0.822|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Mental health summary scale||||0.822
73972818|NCT02865538|147487680|OTHER|Descriptive Analysis|LS means difference|-3.4|STANDARD_ERROR_OF_MEAN|1.25||0.008|TWO_SIDED|90.0|-5.5|-1.3|||Linear mixed-effects model||Day 14 Change from Day -1|||-1.3|-5.5|0.0080
73972819|NCT02865538|147487681|OTHER|Descriptive Analysis|LS means difference|0.84|STANDARD_ERROR_OF_MEAN|0.574||0.1482|TWO_SIDED|90.0|-0.12|1.8|||Linear mixed-effects model||Change from Week -1 to Week 1|||1.80|-0.12|0.1482
73972820|NCT02865538|147487681|OTHER|Descriptive Analysis|LS means difference|-1.04|STANDARD_ERROR_OF_MEAN|0.571||0.0734|TWO_SIDED|90.0|-1.99|-0.09|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.09|-1.99|0.0734
73972821|NCT02865538|147487681|OTHER|Descriptive Analysis|LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|0.565||0.0022|TWO_SIDED|90.0|-2.74|-0.86|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.86|-2.74|0.0022
73935679|NCT02897141|147400811|SUPERIORITY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.25||0.529|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical Function||||0.529
73972822|NCT02865538|147487681|OTHER|Descriptive Analysis|LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.589||0.066|TWO_SIDED|90.0|-2.08|-0.12|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.12|-2.08|0.0660
73972823|NCT02865538|147487681|OTHER|Descriptive Analysis|LS means difference|1.18|STANDARD_ERROR_OF_MEAN|0.613||0.0593|TWO_SIDED|90.0|0.15|2.2|||Linear mixed-effects model||||Change from Week -1 to Week 2|2.20|0.15|0.0593
73972824|NCT02865538|147487681|OTHER||LS means difference|-0.93|STANDARD_ERROR_OF_MEAN|0.614||0.1354|TWO_SIDED|90.0|-1.95|0.1|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.10|-1.95|0.1354
73972825|NCT02865538|147487681|OTHER|Descriptive Analysis|LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|0.603||0.0005|TWO_SIDED|90.0|-3.21|-1.2|||Linear mixed-effects model||Change from Week -1 to Week 2|||-1.20|-3.21|0.0005
73972826|NCT02865538|147487681|OTHER|Descriptive Analysis|LS means difference|-1.38|STANDARD_ERROR_OF_MEAN|0.628||0.0309|TWO_SIDED|90.0|-2.43|-0.34|||Linear mixed-effects model||Change from Week -1 to Week 2|||-0.34|-2.43|0.0309
73972827|NCT02865538|147487682|OTHER|Descriptive analysis|LS means difference|-9.7|STANDARD_ERROR_OF_MEAN|10.88||0.3768|TWO_SIDED|90.0|-27.8|8.5|||Linear mixed-effects model||Change from Day -1 to Day 1|||8.5|-27.8|0.3768
73972828|NCT02865538|147487682|OTHER|Descriptive analysis|LS means difference|-25.0|STANDARD_ERROR_OF_MEAN|10.89||0.0248|TWO_SIDED|90.0|-43.1|-6.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-6.8|-43.1|0.0248
73972829|NCT02865538|147487682|OTHER|Descriptive analysis|LS means difference|-43.9|STANDARD_ERROR_OF_MEAN|10.9||0.0001|TWO_SIDED|90.0|-62.1|-25.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-25.8|-62.1|0.0001
73972830|NCT02865538|147487682|OTHER|Descriptive analysis|LS means difference|-42.9|STANDARD_ERROR_OF_MEAN|11.43||0.0004|TWO_SIDED|90.0|-61.9|-23.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-23.8|-61.9|0.0004
73972831|NCT02865538|147487682|OTHER|Descriptive analysis|LS means difference|10.4|STANDARD_ERROR_OF_MEAN|14.76||0.4819|TWO_SIDED|90.0|-14.2|35.1|||Linear mixed-effects model||Change from Day -1 to Day 7|||35.1|-14.2|0.4819
73866155|NCT00649428|147278591|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||<.00001
73866156|NCT04566601|147278601|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.7||||0.4994|TWO_SIDED|95.0|-1.31|2.69||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||2.69|-1.31|0.4994
73866157|NCT04566601|147278601|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.6||||0.6014|TWO_SIDED|95.0|-2.6|1.51||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.51|-2.60|0.6014
73866158|NCT04566601|147278601|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.2||||0.8166|TWO_SIDED|95.0|-2.17|1.72||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.72|-2.17|0.8166
73935680|NCT02897141|147400811|SUPERIORITY||Mean Difference (Final Values)|1.71|STANDARD_ERROR_OF_MEAN|1.68||0.312|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety||||0.312
73935681|NCT02897141|147400811|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|1.81||0.841|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression||||0.841
73935682|NCT02897141|147400811|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.07||0.848|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue||||0.848
73972832|NCT02865538|147487682|OTHER|Descriptive analysis|LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|14.77||0.8694|TWO_SIDED|90.0|-27.1|22.2|||Linear mixed-effects model||Change from Day -1 to Day 7|||22.2|-27.1|0.8694
73972833|NCT02865538|147487682|OTHER|Descriptive analysis|LS means difference|-23.9|STANDARD_ERROR_OF_MEAN|14.79||0.1105|TWO_SIDED|90.0|-48.6|0.7|||Linear mixed-effects model||Change from Day -1 to Day 7|||0.7|-48.6|0.1105
73935683|NCT02897141|147400811|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|2.03||0.208|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Sleep Disturbance||||0.208
73935684|NCT02897141|147400811|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|2.29||0.754|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Satisfaction with participation in social roles||||0.754
73935685|NCT02897141|147400811|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|1.66||0.454|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain interference||||0.454
73935686|NCT02897141|147400812|SUPERIORITY||Mean Difference (Final Values)|-2.52|STANDARD_ERROR_OF_MEAN|2.19||0.252|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||||||0.252
73935687|NCT02897141|147400813|SUPERIORITY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|0.62||0.017|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||CASE adherence index||||0.017
73935688|NCT02897141|147400813|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|5.06||0.338|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Visual analogue scale||||0.338
73972834|NCT02865538|147487682|OTHER|Descriptive analysis|LS means difference|-18.4|STANDARD_ERROR_OF_MEAN|15.5||0.239|TWO_SIDED|90.0|-44.2|7.4|||Linear mixed-effects model||Change from Day -1 to Day 7|||7.4|-44.2|0.2390
74039411|NCT04847141|147632414|SUPERIORITY||LS Mean Difference|0.01||||0.4956|TWO_SIDED|95.0|-0.02|0.05||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.05|-0.02|0.4956
73935689|NCT02897141|147400814|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.743|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Overall||||0.743
73935690|NCT02897141|147400814|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.2||0.166|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Quality of life||||0.166
73972835|NCT05290493|147487684|SUPERIORITY|||||||0.0672|||||||Mixed Models Analysis|||||||0.0672
73972836|NCT05290493|147487685|SUPERIORITY|||||||0.2045|||||||Mixed Models Analysis|||||||0.2045
73972837|NCT05290493|147487686|SUPERIORITY|||||||0.2931|||||||Mixed Models Analysis|||||||0.2931
73972838|NCT05290493|147487687|SUPERIORITY|||||||0.7799|||||||Mixed Models Analysis|||||||0.7799
73972839|NCT05290493|147487688|SUPERIORITY|||||||0.7974|||||||Mixed Models Analysis|||||||0.7974
73972840|NCT05290493|147487689|SUPERIORITY|||||||0.8286|||||||Mixed Models Analysis|||||||0.8286
73866159|NCT04566601|147278601|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.4||||0.6588|TWO_SIDED|95.0|-1.96|1.24||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.24|-1.96|0.6588
73935691|NCT02897141|147400814|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.26||0.899|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived usefulness||||0.899
73935692|NCT02897141|147400814|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.26||0.803|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived ease of use||||0.803
74030509|NCT00390780|147615282|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.7969|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.7969
73935693|NCT02897141|147400814|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.48|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||User Control||||0.480
73935694|NCT04369469|147400824|OTHER||Risk Difference (RD)|-0.0205||||0.6059|TWO_SIDED|95.0|-0.1703|0.1293||One-sided Mantel-Haenszel test of the difference in two proportions stratified by intubated or not intubated on Day 1 and a family-wise Type I error of 0.025.|Mantel Haenszel||Two-sided 95% confidence interval using the Sato variance estimator, combined overall imputations.|||0.1293|-0.1703|0.6059
73935695|NCT05204134|147400836|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
73935696|NCT05204134|147400837|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
73935697|NCT05204134|147400838|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
73935698|NCT05204134|147400839|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73935699|NCT05204134|147400840|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
73935700|NCT05204134|147400841|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73935701|NCT05204134|147400842|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935702|NCT05204134|147400843|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935703|NCT05204134|147400844|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935704|NCT05204134|147400845|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison between 2 week run-in and 13 weeks Control-IQ use with adaptation.||||<0.001
73935705|NCT05204134|147400846|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935706|NCT05204134|147400847|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935707|NCT05204134|147400848|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935708|NCT05204134|147400849|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935709|NCT05204134|147400850|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935710|NCT05204134|147400851|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935711|NCT05204134|147400852|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935712|NCT05204134|147400853|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935713|NCT05204134|147400854|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73935714|NCT05204134|147400855|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
73935715|NCT05204134|147400856|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73935716|NCT05204134|147400857|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
73935717|NCT01802411|147400878|SUPERIORITY||LSMD|13.1||||0.5598|TWO_SIDED|95.0|-31.0|57.0|||ANCOVA|||||57|-31|0.5598
73935718|NCT03320070|147400980|SUPERIORITY|||||||0.5076|||||||Chi-squared|||||||0.5076
73935719|NCT03320070|147400982|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
73935720|NCT03320070|147400984|SUPERIORITY|||||||0.0848|||||||Chi-squared|||||||0.0848
73935721|NCT03320070|147400986|SUPERIORITY|||||||0.2005|||||||Chi-squared|||||||0.2005
73935722|NCT03320070|147400988|SUPERIORITY|||||||0.9416|||||||Chi-squared|||||||0.9416
73935723|NCT03320070|147400990|SUPERIORITY|||||||0.1853|||||||Chi-squared|||||||0.1853
73935724|NCT03556761|147401030|SUPERIORITY||Risk Ratio (RR)|0.4||||0.03|TWO_SIDED|95.0|0.2|0.81|||Regression, Linear|||||0.81|0.20|0.03
73935725|NCT03556761|147401031|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.12|TWO_SIDED|95.0|0.95|1.51|||Regression, Cox|||||1.51|0.95|0.12
73935726|NCT03556761|147401032|SUPERIORITY||Risk Ratio (RR)|0.55||||0.14|TWO_SIDED|95.0|0.25|1.21|||Chi-squared|||||1.21|0.25|0.14
73935727|NCT03556761|147401033|SUPERIORITY||Risk Ratio (RR)|0.87||||0.36|TWO_SIDED|95.0|0.64|1.18|||Chi-squared|||||1.18|0.64|0.36
73935728|NCT03556761|147401034|SUPERIORITY||Risk Ratio (RR)|0.02||||0.76|TWO_SIDED|95.0|-0.09|0.13|||Regression, Linear|||||.13|-0.09|0.76
73935729|NCT03556761|147401035|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
73935730|NCT03556761|147401036|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|0.32|28.59||||||||28.59|0.32|
73935731|NCT03556761|147401037|SUPERIORITY||Risk Ratio (RR)|0.61||||0.03|TWO_SIDED|95.0|0.39|0.96|||Chi-squared|||||0.96|0.39|0.03
73935732|NCT00693992|147401038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0006|TWO_SIDED|95.0|0.47|0.82|||Log Rank|||||0.82|0.47|0.0006
73935733|NCT00693992|147401039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.89|TWO_SIDED|95.0|0.73|1.31|||Log Rank|||||1.31|0.73|0.89
73935734|NCT00693992|147401041|SUPERIORITY|||||||0.0061|||||||Fisher Exact|||||||0.0061
73935735|NCT00693992|147401042|SUPERIORITY|||||||0.8393|||||||Fisher Exact|||||||0.8393
73935736|NCT01154166|147401049|SUPERIORITY_OR_OTHER||Adjusted mean for treatment difference|-1.76|||<|0.001|TWO_SIDED|95.0|-2.27|-1.26|||ANCOVA||The estimated value indicates the treatment difference for the adjusted mean for Ropinirole PR and placebo.|||-1.26|-2.27|<0.001
73935737|NCT01175382|147401082|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis of Covariance used to compare mean changes from baseline to 6 weeks among groups adjusting for baseline values and age. Last Observation Carried Forward was used for imputation of missing data.||||<.0001
73972841|NCT05419830|147487691|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in sleep time dip in systolic BP. Analysis was adjusted for baseline value of the outcome||||||0.65|||||||ANCOVA|||||||0.65
73972842|NCT05419830|147487692|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in nocturia frequency. Analysis was adjusted for baseline value of the outcome||||||0.66|||||||ANCOVA|||||||0.66
73935738|NCT01175382|147401083|SUPERIORITY_OR_OTHER|||||||0.0013|||||||ANCOVA|||Analysis of Covariance to test for differences in mean change from 6 weeks to 12 weeks in voiding frequency controlling for age and 6 week frequency. Last Observation Carried Forward was used to impute missing data.||||.0013
73935739|NCT01175382|147401084|SUPERIORITY_OR_OTHER|||||||0.2933|||||||ANCOVA|||Analysis of Covariance testing whether mean change in 24-hour voiding frequency differed among the groups after adjusting for baseline voiding frequency and age. Last Observation Carried Forward was used to impute missing data.||||0.2933
73935740|NCT01175382|147401085|SUPERIORITY_OR_OTHER|||||||0.0051|||||||ANCOVA|||Analysis of Covariance used to test means changes among the groups adjusting for baseline values and age. Last Observation Carried Forward was used to impute missing data.||||0.0051
73935741|NCT01175382|147401086|SUPERIORITY_OR_OTHER|||||||0.1402|||||||ANCOVA|||Analysis of Covariance comparing mean change score among groups controlling for age and baseline score||||.1402
73935742|NCT01175382|147401087|SUPERIORITY_OR_OTHER|||||||0.0015|||||||ANCOVA|||Analysis of Covariance comparing mean change in Nocturia among groups adjusting for baseline values of nocturia and age. Last Observation Carried Forward was used to impute missing data.||||0.0015
73935743|NCT01175382|147401088|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||Analysis of Covariance comparing mean change in Overactive Bladder Questionnaire from baseline to 6 weeks among groups after controlling for baseline value and age. Last Observation Carried Forward was used to impute missing data.||||<.0001
73935744|NCT01175382|147401089|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||"Analysis of Covariance comparing mean chance in IPSS from baseline to 6 weeks among groups controlling for baseline IPSS values and age.~Last Observation Carried Forward was used to impute missing data."||||<.0001
73935745|NCT01175382|147401090|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Cochran-Mantel-Haenszel|||||||0.0022
73935746|NCT01175382|147401091|SUPERIORITY_OR_OTHER|||||||0.0222|||||||Cochran-Mantel-Haenszel|||||||.0222
73935747|NCT01175382|147401092|SUPERIORITY_OR_OTHER|||||||0.0217|||||||Cochran-Mantel-Haenszel|||||||.0217
73935748|NCT01175382|147401093|SUPERIORITY_OR_OTHER|||||||0.669|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in Urgency Score from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week Urgency Score. Last Observation Carried Forward was used to impute missing values.||||0.6690
73935749|NCT01175382|147401094|SUPERIORITY_OR_OTHER|||||||0.0812|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Incontinence Episodes from 6 weeks to 12 weeks differed among groups after controlling for age and frequency of incontinence episodes at 6 weeks. Last Observation Carried Forward was used to impute missing values.||||0.0812
73972843|NCT05419830|147487693|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in NPi. Analysis was adjusted for baseline value of the outcome||||||0.14|||||||ANCOVA|||||||0.14
73935750|NCT01175382|147401095|SUPERIORITY_OR_OTHER|||||||0.5578|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in nocturia from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week nocturia frequency. Last Observation Carried Forward was used to impute missing values.||||0.5578
73935751|NCT01175382|147401096|SUPERIORITY_OR_OTHER|||||||0.0279|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Overactive Bladder Questionnaire (OAB-q) from 6 to 12 weeks differed among groups after controlling for age and 6 week OAB-q score. Last Observation Carried Forward was used to impute missing values.||||0.0279
73935752|NCT01175382|147401097|SUPERIORITY_OR_OTHER|||||||0.2553|||||||ANCOVA|||Analysis of Covariance to test whether mean change in the International Prostate Symptom Scale (IPSS) from 6 to 12 weeks differed among groups||||0.2553
73935753|NCT01175382|147401098|SUPERIORITY_OR_OTHER|||||||0.3165|||||||Cochran-Mantel-Haenszel|||||||0.3165
73935754|NCT01175382|147401099|SUPERIORITY_OR_OTHER|||||||0.8153|||||||Cochran-Mantel-Haenszel|||||||0.8153
73935755|NCT01175382|147401100|SUPERIORITY_OR_OTHER|||||||0.5536|||||||Cochran-Mantel-Haenszel|||||||0.5536
73935756|NCT01175382|147401101|SUPERIORITY_OR_OTHER|||||||0.2035|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Nocturia frequency differed among the groups after adjusting for baseline Nocturia frequency and age. Last Observation Carried Forward was used to impute missing data||||0.2035
73935757|NCT01175382|147401102|SUPERIORITY_OR_OTHER|||||||0.0549|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Urgency Score differed among the groups after adjusting for Urgency Scoe and age. Last Observation Carried Forward was used to impute missing data||||.0549
73935758|NCT01175382|147401103|SUPERIORITY_OR_OTHER|||||||0.507|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Incontinent Episodes differed among the groups after adjusting for baseline Incontinent episodes frequency and age. Last Observation Carried Forward was used to impute missing data||||0.5070
73972844|NCT05419830|147487694|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in PSQI scores. Analysis was adjusted for baseline value of the outcome||||||0.2|||||||ANCOVA|||||||0.2
73972845|NCT05419830|147487695|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in sleep efficiency. Analysis was adjusted for baseline value of the outcome||||||0.02|||||||ANCOVA|||||||0.02
74039412|NCT04847141|147632414|SUPERIORITY||LS Mean Difference|-0.05||||0.22|TWO_SIDED|95.0|-0.13|0.03||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.03|-0.13|0.2200
73866160|NCT04566601|147278601|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.3914|||||||MCP-Mod sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 25 mg, and 90% of the maximum effect is achieved at 75 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.3914
73866161|NCT04566601|147278601|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10 and 12) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4104|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of the maximum effect is achieved at 25 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4104
73935759|NCT01175382|147401104|SUPERIORITY_OR_OTHER|||||||0.0529|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Overactive Bladder Questionnaire differed among the groups after adjusting for baseline Overactive Bladder Questionnaire Score and age. Last Observation Carried Forward was used to impute missing data||||.0529
73866162|NCT04566601|147278601|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.456|||||||MCP-Mod linear model fit|Model assumption: No parameter assumptions required.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4560
73935760|NCT01175382|147401105|SUPERIORITY_OR_OTHER|||||||0.2384|||||||ANCOVA|||Analysis of Covariance to test whether mean change in International Prostate Symptom Score from Baseline to 12 weeks differed among groups after controlling for baseline International Prostate Symptom Score and age. Last Observation Carried Forward was used to impute missing values.||||0.2384
73935761|NCT02019719|147401110|SUPERIORITY_OR_OTHER||E0 (g/dL)|-1.37|||||TWO_SIDED|95.0|-1.72|-1.03|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-1.03|-1.72|
73935762|NCT02019719|147401110|SUPERIORITY_OR_OTHER||ED50 (mg)|21.88|||||TWO_SIDED|95.0|9.99|42.64|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||42.64|9.99|
73935763|NCT02019719|147401110|SUPERIORITY_OR_OTHER||Emax (g/dL)|5.88|||||TWO_SIDED|95.0|3.2|8.61|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||8.61|3.20|
73935764|NCT02019719|147401110|SUPERIORITY_OR_OTHER||Gamma|1.13|||||TWO_SIDED|95.0|0.7|1.68|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.68|0.70|
73935765|NCT02019719|147401110|SUPERIORITY_OR_OTHER||Var|0.66|||||TWO_SIDED|95.0|0.5|0.88|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||0.88|0.50|
73935766|NCT02019719|147401110|SUPERIORITY_OR_OTHER||MED (mg)|1.98|||||TWO_SIDED|95.0|0.75|3.41|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||3.41|0.75|
73935767|NCT02019719|147401110|SUPERIORITY_OR_OTHER||TD (mg)|3.9|||||TWO_SIDED|95.0|2.2|5.63|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||5.63|2.20|
73935768|NCT02019719|147401110|SUPERIORITY_OR_OTHER||MAD (mg)|8.65|||||TWO_SIDED|95.0|6.51|11.44|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||11.44|6.51|
73935769|NCT02203019|147401128|EQUIVALENCE|Outcome comparison used the Mann Whitney U test||||||0.107|||||||Wilcoxon (Mann-Whitney)|||||||0.107
73935770|NCT02203019|147401129|EQUIVALENCE|Outcomes were compared using a Mann Whitney U test.||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.260
73935771|NCT02203019|147401130|EQUIVALENCE|Outcomes were compared using a Mann Whitney U test.||||||0.376|||||||Wilcoxon (Mann-Whitney)|||||||0.376
73935772|NCT02203019|147401131|EQUIVALENCE|Outcomes were compared using a Chi square test.||||||0.739|||||||Chi-squared|||||||0.739
73935773|NCT02731131|147401133|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
73935774|NCT02731131|147401135|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher Exact|||||||0.22
73935775|NCT02731131|147401136|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
73935776|NCT02731131|147401137|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
73935777|NCT02731131|147401138|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
73935778|NCT02509624|147401139|OTHER||%Geometric least-square mean(GLSM) ratio|105.08|||||TWO_SIDED|90.0|77.08|143.23||||||AUCinf of selonsertib||143.23|77.08|
73935779|NCT02509624|147401139|OTHER||% GLSM ratio|142.65|||||TWO_SIDED|90.0|120.52|168.84||||||AUCinf of selonsertib||168.84|120.52|
73935780|NCT02509624|147401139|OTHER||% GLSM ratio|110.55|||||TWO_SIDED|90.0|86.99|140.49||||||AUCinf of selonsertib||140.49|86.99|
73935781|NCT02509624|147401139|OTHER||% GLSM ratio|62.05|||||TWO_SIDED|90.0|43.84|87.81||||||AUCinf of GS-607509||87.81|43.84|
73935782|NCT02509624|147401139|OTHER||% GLSM ratio|66.44|||||TWO_SIDED|90.0|36.72|120.21||||||AUCinf of GS-607509||120.21|36.72|
73935783|NCT02509624|147401139|OTHER||% GLSM ratio|103.46|||||TWO_SIDED|90.0|51.75|206.83||||||AUCinf of GS-607509||206.83|51.75|
73935784|NCT02509624|147401140|OTHER||% GLSM ratio|99.87|||||TWO_SIDED|90.0|73.38|135.92||||||AUClast of selonsertib||135.92|73.38|
73935785|NCT02509624|147401140|OTHER||% GLSM ratio|141.75|||||TWO_SIDED|90.0|118.5|169.55||||||AUClast of selonsertib||169.55|118.50|
73935786|NCT02509624|147401140|OTHER||% GLSM ratio|112.24|||||TWO_SIDED|90.0|87.69|143.65||||||AUClast of selonsertib||143.65|87.69|
73935787|NCT02509624|147401140|OTHER||% GLSM ratio|61.2|||||TWO_SIDED|90.0|43.06|86.98||||||AUClast of GS-607509||86.98|43.06|
73866163|NCT04566601|147278601|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4908|||||||MCP-Mod exponential model fit|Model assumption: 5% of the maximum effect is achieved at 25 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4908
73866164|NCT04566601|147278601|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4974|||||||MCP-Mod Emax2 model fit|Model assumption: 70% of the maximum effect is achieved at 5 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4974
73866165|NCT04566601|147278602|OTHER||Odds Ratio (OR)|0.486|||||TWO_SIDED|95.0|0.207|1.14|||||Odds Ratio of BI 1358894 5mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||1.140|0.207|
73866166|NCT04566601|147278602|OTHER||Odds Ratio (OR)|2.294|||||TWO_SIDED|95.0|0.829|7.48|||||Odds Ratio of BI 1358894 25mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||7.480|0.829|
73935788|NCT02509624|147401140|OTHER||% GLSM ratio|61.07|||||TWO_SIDED|90.0|33.62|110.91||||||AUClast of GS-607509||110.91|33.62|
73935789|NCT02509624|147401140|OTHER||% GLSM ratio|96.13|||||TWO_SIDED|90.0|48.47|190.67||||||AUClast of GS-607509||190.67|48.47|
73935790|NCT02509624|147401141|OTHER||% GLSM ratio|88.68|||||TWO_SIDED|90.0|74.83|105.1||||||Cmax of selonsertib||105.10|74.83|
73972846|NCT04615273|147487696|SUPERIORITY||Estimate of Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-2.94|-1.14|||ANCOVA|||Analysis included treatment arm, region, baseline age group, gender, concomitant oral estrogen, Adult Growth Hormone Deficiency (AGHD) onset as factors \& baseline trunk percent fat as the covariates. Multiple imputation method was used to impute missing data.||-1.14|-2.94|<.0001
73866167|NCT04566601|147278602|OTHER||Odds Ratio (OR)|1.753|||||TWO_SIDED|95.0|0.698|4.861|||||Odds Ratio of BI 1358894 75mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||4.861|0.698|
74030510|NCT00390780|147615283|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.882|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|||-0.15|0.8820
73866168|NCT04566601|147278602|OTHER||Odds Ratio (OR)|1.352|||||TWO_SIDED|95.0|0.642|2.913|||||Odds Ratio of BI 1358894 125mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||2.913|0.642|
73935791|NCT02509624|147401141|OTHER||% GLSM ratio|91.16|||||TWO_SIDED|90.0|78.76|105.52||||||Cmax of selonsertib||105.52|78.76|
73935792|NCT02509624|147401141|OTHER||% GLSM ratio|100.19|||||TWO_SIDED|90.0|83.73|119.88||||||Cmax of selonsertib||119.88|83.73|
73935793|NCT02509624|147401141|OTHER||% GLSM ratio|71.44|||||TWO_SIDED|90.0|54.58|93.5||||||Cmax of GS-607509||93.50|54.58|
73935794|NCT02509624|147401141|OTHER||% GLSM ratio|46.92|||||TWO_SIDED|90.0|32.59|67.54||||||Cmax of GS-607509||67.54|32.59|
73935795|NCT02509624|147401141|OTHER||% GLSM ratio|93.93|||||TWO_SIDED|90.0|67.6|130.5||||||Cmax of GS-607509||130.50|67.60|
73935796|NCT01055639|147401172|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
73935797|NCT01055639|147401173|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
73935798|NCT01055639|147401174|SUPERIORITY_OR_OTHER|||||||0.88|||||||t-test, 2 sided|||||||0.88
73935799|NCT01055639|147401175|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
73935800|NCT01055639|147401176|SUPERIORITY_OR_OTHER|||||||0.87|||||||t-test, 2 sided|||||||0.87
73935801|NCT01055639|147401177|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
73935802|NCT01055639|147401178|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 2 sided|||||||0.19
73935803|NCT01055639|147401179|SUPERIORITY_OR_OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
73935804|NCT01055639|147401180|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
73935805|NCT00562159|147401181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|||=|0.005|TWO_SIDED|95.0|-2.22|-0.4|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.40|-2.22|=0.005
73972847|NCT03677141|147487710|SUPERIORITY||Difference in rates|-4.77|||||TWO_SIDED|95.0|-30.61|21.07||||||||21.07|-30.61|
73972848|NCT05465239|147487727|EQUIVALENCE|Equivalence analysis of metabolic energy consumption using the unpowered vs powered walker for control subjects.|||||<|0.001|||||||t-test, 1 sided|||||||< 0.001
73866169|NCT04566601|147278603|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.1||||0.9675|TWO_SIDED|95.0|-5.11|4.9||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.90|-5.11|0.9675
73866170|NCT04566601|147278603|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.01||||0.9969|TWO_SIDED|95.0|-5.08|5.1||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.10|-5.08|0.9969
73866171|NCT04566601|147278603|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.79||||0.7542|TWO_SIDED|95.0|-5.73|4.15||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.15|-5.73|0.7542
73866172|NCT04566601|147278603|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.17||||0.5683|TWO_SIDED|95.0|-2.86|5.19||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.19|-2.86|0.5683
73935806|NCT00562159|147401182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||=|0.015|TWO_SIDED|95.0|-1.46|-0.26|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.26|-1.46|=0.015
73935807|NCT00562159|147401183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||=|0.084|TWO_SIDED|95.0|-0.96|0.06|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||0.06|-0.96|=0.084
73935808|NCT00562159|147401184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||=|0.022|TWO_SIDED|95.0|-0.48|-0.05|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.05|-0.48|=0.022
73935809|NCT01614210|147401206|OTHER||percentage decrease in Ki67 after 7 days|||||0.0001|||||||t-test, 1 sided|||||||0.0001
73935810|NCT02162810|147401212|OTHER||||||<|0.62|||||||Fisher Exact|||Due to the number of 0 cell counts, it is not possible to do individual statistics for each complication, so we looked at the incidence of complications overall between the two arms.||||<.62
73935811|NCT02162810|147401213|OTHER||||||<|0.61|||||||Fisher Exact|||||||<0.61
73972849|NCT05465239|147487727|EQUIVALENCE|Equivalence analysis of metabolic energy consumption using the unpowered vs powered walker for subjects with walking disabilities.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73866173|NCT04566601|147278604|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-2.07||||0.3568|TWO_SIDED|95.0|-6.49|2.35||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||2.35|-6.49|0.3568
73935812|NCT02162810|147401214|OTHER||||||<|0.87|||||||Fisher Exact|||Improvement category: Chordee with Degloving||||<.87
73935813|NCT02162810|147401214|OTHER||||||<|0.64|||||||Fisher Exact|||Improvement category: Ventral Chordee||||<.64
73935814|NCT02162810|147401214|OTHER||||||<|0.85|||||||Fisher Exact|||Improvement category: Chordee with Plication||||<.85
73935815|NCT00706121|147401220|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.96||||0.96|TWO_SIDED|95.0|0.9|1.02|||Log binomial regression|||||1.02|0.9|0.96
73935816|NCT00706121|147401221|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.92||||0.32|TWO_SIDED|95.0|0.78|1.08|||Log binomial regression|||||1.08|0.78|0.32
73935817|NCT00706121|147401223|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.91||||0.24|TWO_SIDED|95.0|0.77|1.07|||Log binomial regression|||||1.07|0.77|0.24
73935818|NCT00706121|147401224|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.38|TWO_SIDED|95.0|0.96|1.1|||Log binomial regression|||||1.10|0.96|0.38
73935819|NCT02223390|147401263|SUPERIORITY|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot randomized controlled trial (RCT) with two conditions.||||||0.08||||||A priori threshold for statistical significance was p\<.05. The p-value presented corresponds to the time by condition interaction parameter.|Mixed Models Analysis|To assess changes in PTSD symptoms over time by intervention condition, linear mixed models were fit using the PROC MIXED procedure in SAS.||Statistical analyses reported below is for PCL - Total at 3 months.||||0.08
73972850|NCT05423730|147487752|SUPERIORITY||Mean Difference (Final Values)|-11.12|||||TWO_SIDED|95.0|-49.75|57.2|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||57.20|-49.75|
73972851|NCT05423730|147487753|SUPERIORITY||Mean Difference (Final Values)|7.65|||||TWO_SIDED|95.0|-47.96|63.9|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||63.90|-47.96|
73866174|NCT04566601|147278604|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.21||||0.6009|TWO_SIDED|95.0|-3.33|5.75||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.75|-3.33|0.6009
73935820|NCT02223390|147401264|SUPERIORITY|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot RCT with two conditions.||||||0.05||||||A priori threshold was defined as p\<0.05.|Chi-squared|||||||0.05
73866175|NCT04566601|147278604|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.36||||0.8705|TWO_SIDED|95.0|-4.7|3.98||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||3.98|-4.70|0.8705
73866176|NCT04566601|147278604|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.15||||0.5262|TWO_SIDED|95.0|-2.41|4.71||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.71|-2.41|0.5262
73935821|NCT02265705|147401343|SUPERIORITY||Odds Ratio (OR)|4.1||||0.001|TWO_SIDED|95.0|2.5|6.9|||Regression, Logistic|||||6.9|2.5|0.001
73935822|NCT02265705|147401344|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.056||0.001|TWO_SIDED|95.0|-0.31|-0.09|||ANCOVA|||||-0.09|-0.31|0.001
73935823|NCT02265705|147401345|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.116||0.001|TWO_SIDED|95.0|-1.25|-0.79|||ANCOVA|||||-0.79|-1.25|0.001
73935824|NCT02265705|147401346|SUPERIORITY||Difference in response rate|1.4|||||TWO_SIDED|95.0|-0.5|3.3||||||||3.3|-0.5|
73935825|NCT02265705|147401347|SUPERIORITY||Median Difference (Final Values)|-12.9||||0.004|TWO_SIDED|95.0|-28.0|-2.9|||Wilcoxon (Mann-Whitney)|||||-2.9|-28.0|0.004
73866177|NCT04566601|147278605|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-1.83||||0.0782|TWO_SIDED|95.0|-3.87|0.21||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.21|-3.87|0.0782
73866178|NCT04566601|147278605|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.23||||0.8266|TWO_SIDED|95.0|-1.86|2.32||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||2.32|-1.86|0.8266
73935826|NCT02265705|147401348|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.2|-0.3|||ANCOVA|||||-0.3|-1.2|0.002
73935827|NCT02265705|147401349|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|0.001
73935828|NCT02265705|147401350|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|||||-0.5|-1.3|0.001
73935829|NCT00779246|147401351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||>|0.05|TWO_SIDED|95.0|0.5|2.9|||Regression, Logistic|||Null hypothesis was that ASC and CHG would be no different in preventing acquisition of MRSA.||2.9|0.5|>0.05
73935830|NCT00736996|147401368|SUPERIORITY_OR_OTHER||||||<|0.0125|TWO_SIDED|||||Statistical significance was defined as a 2-sided p-value \< 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with PIO was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.||||<0.0125
73935831|NCT00736996|147401368|SUPERIORITY_OR_OTHER||||||<|0.0125|TWO_SIDED|||||Statistical significance was defined as a 2-sided p-value \< 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with EET was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.||||<0.0125
73972852|NCT05423730|147487754|SUPERIORITY||Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-1.95|0.67|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||0.67|-1.95|
73972853|NCT05423730|147487755|SUPERIORITY||Mean Difference (Final Values)|13.83|||||TWO_SIDED|95.0|-9.45|43.09|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||43.09|-9.45|
73866179|NCT04566601|147278605|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.27||||0.791|TWO_SIDED|95.0|-2.28|1.74||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||1.74|-2.28|0.7910
73866180|NCT04566601|147278605|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.8743|TWO_SIDED|95.0|-1.77|1.51||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||1.51|-1.77|0.8743
73935832|NCT00736996|147401369|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
73935833|NCT00736996|147401369|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
73935834|NCT00736996|147401370|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
73935835|NCT00736996|147401370|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
73935836|NCT00383435|147401408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
73935837|NCT00383435|147401408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||ANCOVA|||||||0.007
73935838|NCT00383435|147401409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
73935839|NCT00383435|147401409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029|||||||ANCOVA|||||||0.029
73935840|NCT00383435|147401410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||||||0.002
73935841|NCT00383435|147401410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059|||||||ANCOVA|||||||0.059
73935842|NCT03447769|147401438|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.258|TWO_SIDED|95.0|0.78|1.14||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|||1.14|0.78|0.258
73935843|NCT03447769|147401443|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.676|TWO_SIDED|95.0|0.76|1.58||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 \<1%||1.58|0.76|0.676
73935844|NCT03447769|147401443|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.036|TWO_SIDED|95.0|0.34|1.05||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 ≥1% and \<49%||1.05|0.34|0.036
73935845|NCT03447769|147401443|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.823|TWO_SIDED|95.0|0.73|2.43||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 ≥50%||2.43|0.73|0.823
73935846|NCT03447769|147401444|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.872|TWO_SIDED|95.0|0.87|1.72||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|CD8 \< median||1.72|0.87|0.872
73935847|NCT03447769|147401444|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.303|TWO_SIDED|95.0|0.62|1.33||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|CD8 ≥ median||1.33|0.62|0.303
73935848|NCT01343407|147401465|OTHER||Difference in Least Squares Means (LSM)|-22.2||||0.011|TWO_SIDED|90.0|-35.7|-8.7|||Linear mixed effects model|||||-8.7|-35.7|0.011
73935849|NCT01343407|147401465|OTHER||Difference in LSM|-18.9||||0.023|TWO_SIDED|90.0|-32.1|-5.8|||Linear mixed effects model|||||-5.8|-32.1|0.023
73935850|NCT01343407|147401466|OTHER||LS Mean Ratio (LSMR)|0.48||||0.006|TWO_SIDED|90.0|0.32|0.72|||Linear mixed effects model||||% Inhibition: 52.2 (90% CI: 28.3, 68.2). The % Inhibition of FEV1\*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100\*(1-LSMR).|0.72|0.32|0.006
73935851|NCT01343407|147401466|OTHER||LS Mean Ratio (LSMR)|0.58||||0.012|TWO_SIDED|90.0|0.41|0.81|||Linear mixed effects model||||% Inhibition: 42.4 (90% CI: 19.3, 58.8) The % Inhibition of FEV1\*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100\*(1-LSMR).|0.81|0.41|0.012
73935852|NCT01343407|147401467|OTHER||LSM Difference|85.84|||<|0.001|TWO_SIDED|90.0|65.3|106.4|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough|||106.4|65.3|<0.001
73935853|NCT01343407|147401467|OTHER||LSM Difference|83.29|||<|0.001|TWO_SIDED|90.0|63.9|102.7|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough|||102.7|63.9|<0.001
73935854|NCT00289341|147401511|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||for injection site reaction only||||0.001
73935855|NCT00289341|147401511|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||Fisher Exact|||for all other adverse events||||>0.2
73866181|NCT04566601|147278606|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.05||||0.8016|TWO_SIDED|95.0|-0.47|0.37||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.37|-0.47|0.8016
73866182|NCT04566601|147278606|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.23||||0.2929|TWO_SIDED|95.0|-0.67|0.2||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.20|-0.67|0.2929
73866183|NCT04566601|147278606|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.01||||0.9666|TWO_SIDED|95.0|-0.42|0.4||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.40|-0.42|0.9666
73866184|NCT04566601|147278606|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.18||||0.2833|TWO_SIDED|95.0|-0.52|0.15||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.15|-0.52|0.2833
73935856|NCT00289341|147401513|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Linear Spline model|||||||0.016
73935857|NCT04102501|147401522|SUPERIORITY|||||||0.5858|||||||Mixed Models Analysis|||||||0.5858
73935858|NCT04102501|147401523|SUPERIORITY|||||||0.8061|||||||Mixed Models Analysis|||||||0.8061
73935859|NCT02120924|147401566|EQUIVALENCE|Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval \[0.80, 1.25\].|Mean Difference (Net)|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval \[0.80, 1.25\].|The primary endpoint was the percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population.||1.05|0.92|
74039413|NCT04847141|147632414|SUPERIORITY||LS Mean Difference|-0.07||||0.0906|TWO_SIDED|95.0|-0.14|0.01||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.01|-0.14|0.0906
73935860|NCT02120924|147401567|EQUIVALENCE|A two-sided, continuity-corrected, 90% CI on the Test-to-Reference difference for the proportion of subjects with treatment success on the IGE was constructed.|Mean Difference (Net)|0.044|||||TWO_SIDED|90.0|-0.028|0.116|||||Bioequivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\].|||0.116|-0.028|
73935861|NCT01884350|147401568|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.24||||0.8117|TWO_SIDED|95.0|-2.18|1.7||P-value (two-sided) corresponds to the two-sample t-tests for difference in percentage of adherence at Week 24|t-test, 2 sided|||||1.7|-2.18|0.8117
73935862|NCT01884350|147401569|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks||||<0.0001
73935863|NCT01884350|147401569|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks||||<0.0001
73935864|NCT01884350|147401570|NON_INFERIORITY_OR_EQUIVALENCE|F-test p-value is obtained from the one-way ANOVA model||||||0.8707|||||||ANOVA|||||||0.8707
73935865|NCT01884350|147401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.6399|TWO_SIDED|95.0|-2.88|4.68||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||4.68|-2.88|0.6399
73935866|NCT01884350|147401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.9616|TWO_SIDED|95.0|-3.45|3.29||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||3.29|-3.45|0.9616
73935867|NCT01884350|147401570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.6341|TWO_SIDED|95.0|-2.6|4.24||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||4.24|-2.60|0.6341
73935868|NCT01884350|147401571|SUPERIORITY|||||||0.1924||||||\<=2 Drink/Day Average vs None|Wald Chi-square test|||||||0.1924
73935869|NCT01884350|147401571|SUPERIORITY|||||||0.0305||||||\>=3 Drink/Day Average vs None|Wald Chi-square test|||||||0.0305
73935870|NCT01884350|147401571|SUPERIORITY|||||||0.0107||||||Mini-mental state examination score|Wald Chi-square test|||||||0.0107
73935871|NCT01884350|147401571|SUPERIORITY|||||||0.6982||||||Higher managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test|||||||0.6982
73935872|NCT01884350|147401571|SUPERIORITY|||||||0.7277||||||Higher professional occupations vs UKSOC1|Wald Chi-square test|||||||0.7277
73935873|NCT01884350|147401571|SUPERIORITY|||||||0.7581||||||Intermediate occupations vs UKSOC1|Wald Chi-square test|||||||0.7581
73935874|NCT01884350|147401571|SUPERIORITY|||||||0.2328||||||Large employers and higher managerial and adm. occupations vs UKSOC1|Wald Chi-square test|||||||0.2328
73935875|NCT01884350|147401571|SUPERIORITY|||||||0.7507||||||Lower managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test|||||||0.7507
73935876|NCT01884350|147401571|SUPERIORITY|||||||0.0091||||||Lower supervisory and technical occupations vs UKSOC1|Wald Chi-square test|||||||0.0091
73935877|NCT01884350|147401571|SUPERIORITY|||||||0.673||||||Never worked and long-term unemployed vs UKSOC1|Wald Chi-square test|||||||0.6730
73935878|NCT01884350|147401571|SUPERIORITY|||||||0.0117||||||Routine occupations vs UKSOC1|Wald Chi-square test|||||||0.0117
73935879|NCT01884350|147401571|SUPERIORITY|||||||0.191||||||Semi-routine occupations vs UKSOC1|Wald Chi-square test|||||||0.1910
73935880|NCT01884350|147401571|SUPERIORITY|||||||0.9559||||||Paroxysmal vs Persistent Atrial Fibrillation|Wald Chi-square test|||||||0.9559
73935881|NCT01884350|147401571|SUPERIORITY|||||||0.0264||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.0264
73935882|NCT01884350|147401571|SUPERIORITY|||||||0.1087||||||\<=2 Drink/Day Average vs None|Wald Chi-square test|||||||0.1087
73935883|NCT01884350|147401571|SUPERIORITY|||||||0.0679||||||\>=3 Drink/Day Average vs None|Wald Chi-square test|||||||0.0679
73935884|NCT01884350|147401571|SUPERIORITY|||||||0.2128||||||Paroxysmal vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.2128
73935885|NCT01884350|147401571|SUPERIORITY|||||||0.3739||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.3739
73935886|NCT01884350|147401571|SUPERIORITY|||||||0.843||||||VKA status: Naive vs. Non-Naive|Wald Chi-square test|||||||0.843
73935887|NCT01968434|147401588|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The sample size was calculated to detect a 0.75 point difference between any two treatment groups with a 90% power and p\<0.05. Such sample size was 60 subject which was elevated ot 75 subjects per group to account for drop outs. For comparison of cough evaluation before and after treatment a paired Student t test was used.||||<0.01
73935888|NCT01968434|147401589|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
73935889|NCT01968434|147401590|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73935890|NCT02669329|147401591|OTHER||success proportion|85.2|||||TWO_SIDED|95.0|72.9|93.4||||||||93.4|72.9|
73935891|NCT01543256|147401593|NON_INFERIORITY|Non-Inferiority margin was 20%||||||0.008|||||||Exact non-inferiority|||||||.008
73935892|NCT01543256|147401594|SUPERIORITY|||||||0.568|||||||Fisher Exact|||||||.568
73935893|NCT01543256|147401595|SUPERIORITY||||||<|0.001|||||||Negative binomial|||||||<.001
73935894|NCT01543256|147401596|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||.99
73935895|NCT01543256|147401597|SUPERIORITY|||||||0.519|||||||Wilcoxon (Mann-Whitney)|||||||.519
73935896|NCT01543256|147401598|SUPERIORITY||||||<|0.001|||||||Negative binomial|||||||<.001
73935897|NCT02055352|147401640|NON_INFERIORITY_OR_EQUIVALENCE|A change of 5-10% from baseline values is considered to be clinically important. The estimated adjusted treatment difference for budesonide 400 μg twice a day/ indacaterol 150 μg once daily minus fixed combination of fluticasone/ salmeterol 250/ 50 μg twice daily was displayed along with the associated one-sided 97.5% confidence interval. If the lower limit of this confidence interval was to the right (i.e. above) - 10 mL, then non-inferiority could be claimed.||||||0.004|||||||Mixed effects General linear model|||||||0.004
73935898|NCT02062502|147401649|NON_INFERIORITY_OR_EQUIVALENCE|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-3.2|3.2|||Miettinen and Nurminen|||||3.2|-3.2|<0.001
73935899|NCT02062502|147401650|NON_INFERIORITY_OR_EQUIVALENCE|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on fold-difference, excluding a decrease of 1.5 fold or more.|Risk Difference (RD)|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||t-test, 2 sided|||||1.06|0.85|<0.001
73935900|NCT02062502|147401650|SUPERIORITY_OR_OTHER||Antibody Response Rate|97.2|||<|0.001|TWO_SIDED|95.0|94.4|98.9|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being \>76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).||98.9|94.4|<0.001
73935901|NCT03809182|147401656|SUPERIORITY|||||||0.38|TWO_SIDED|95.0||||A p-value less than .05 was considered statistically significant.|Mixed Models Analysis|||Null hypothesis: There is no difference in plasmatic glucose levels between dexmedetomidine and 0.9% sodium-chloride groups.||||0.38
73935902|NCT03809182|147401657|SUPERIORITY|||||||0.02||||||A p-value less than .05 was considered statistically significant.|Mixed Models Analysis|||Null hypothesis: There is no difference in insulin levels between dexmedetomidine and 0.9% sodium-chloride groups.||||0.02
73957838|NCT03068468|147451202|SUPERIORITY||Difference|0.006||||0.685|TWO_SIDED|95.0|-0.025|0.038|||MMRM|||Third Ventricle Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.038|-0.025|0.6850
73935903|NCT00489970|147401671|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.41|||||TWO_SIDED|97.5|-1.16|4.17|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.||4.17|-1.16|
73972854|NCT05423730|147487756|SUPERIORITY||Mean Difference (Final Values)|11.42|||||TWO_SIDED|95.0|-3.31|28.4|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||28.40|-3.31|
73935904|NCT00489970|147401671|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||TWO_SIDED|97.5|-1.52|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.||2.07|-1.52|
73935905|NCT00489970|147401671|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.32|||||TWO_SIDED|97.5|-3.41|4.15|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.||4.15|-3.41|
73935906|NCT00489970|147401671|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||TWO_SIDED|97.5|-3.69|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.||2.07|-3.69|
73935907|NCT00489970|147401673|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.53|||||TWO_SIDED|97.5|1.31|1.79|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination||1.79|1.31|
73935908|NCT00489970|147401673|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||TWO_SIDED|97.5|4.62|6.01|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination||6.01|4.62|
73972855|NCT05423730|147487757|SUPERIORITY||Mean Difference (Final Values)|12.57|||||TWO_SIDED|95.0|-0.77|27.69|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||27.69|-0.77|
73972856|NCT05423730|147487758|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-21.92|21.24|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||21.24|-21.92|
73972857|NCT03673501|147487759|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3598|TWO_SIDED|95.0|0.66|1.16|||Log Rank|Strata: by intolerance to imatinib treatment||||1.16|0.66|0.3598
73972858|NCT03673501|147487760|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7153|TWO_SIDED|95.0|0.82|1.33||Two-sided P-value|Log Rank|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment||||1.33|0.82|0.7153
73972859|NCT03673501|147487761|SUPERIORITY|||||||0.0333|||||||Cochran-Mantel-Haenszel|Strata: intolerance to imatinib treatment||||||0.0333
73972860|NCT03673501|147487762|SUPERIORITY|||||||0.2681|||||||Cochran-Mantel-Haenszel|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment||||||0.2681
73972861|NCT03673501|147487763|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7733|TWO_SIDED|95.0|0.75|1.48|||Log Rank|Strata: intolerance to imatinib treatment||||1.48|0.75|0.7733
73972862|NCT03673501|147487764|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3928|TWO_SIDED|95.0|0.66|1.18|||Log Rank|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib||||1.18|0.66|0.3928
74039414|NCT04847141|147632414|SUPERIORITY||LS Mean Difference|-0.04||||0.0439|TWO_SIDED|95.0|-0.07|0.0||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||-0.00|-0.07|0.0439
73935909|NCT00489970|147401673|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|3.62|||||TWO_SIDED|97.5|3.07|4.25|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination||4.25|3.07|
73935910|NCT00489970|147401673|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.64||||||97.5|1.33|2.03|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination||2.03|1.33|
73935911|NCT00489970|147401673|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||TWO_SIDED|97.5|4.37|6.36|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination||6.36|4.37|
73935912|NCT00489970|147401673|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|4.47|||||TWO_SIDED|97.5|3.58|5.57|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination||5.57|3.58|
73935913|NCT00489970|147401674|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-5.91|||||TWO_SIDED|97.5|-14.67|2.85|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.||2.85|-14.67|
73935914|NCT00489970|147401674|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.44|||||TWO_SIDED|97.5|-10.63|7.79|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.||7.79|-10.63|
73935915|NCT00489970|147401674|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-8.56|||||TWO_SIDED|97.5|-20.33|2.73|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.||2.73|-20.33|
73935916|NCT00489970|147401674|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-11.79|||||TWO_SIDED|97.5|-22.98|0.15|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.||0.15|-22.98|
73957839|NCT03068468|147451202|SUPERIORITY||Difference|-0.041||||0.9|TWO_SIDED|95.0|-0.68|0.598|||MMRM|||Frontal Lobe Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.598|-0.680|0.9000
73935917|NCT00489970|147401675|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-2.85|||||TWO_SIDED|97.5|-9.09|3.08|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.||3.08|-9.09|
73935918|NCT00489970|147401675|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-7.05|||||TWO_SIDED|97.5|-13.16|-1.4|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.||-1.40|-13.16|
73935919|NCT00489970|147401675|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-10.32|||||TWO_SIDED|97.5|-17.5|-3.38|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.||-3.38|-17.50|
73935920|NCT00489970|147401675|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.24|||||TWO_SIDED|97.5|-10.03|5.57|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.||5.57|-10.03|
73935921|NCT00489970|147401675|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|4.01|||||TWO_SIDED|97.5|-2.38|8.66|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.||8.66|-2.38|
73972863|NCT05838027|147487765|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|3.24|||||TWO_SIDED|95.0|0.84|12.55||||||||12.55|0.84|
73972864|NCT05838027|147487766|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.24|2.64||||||||2.64|0.24|
73972865|NCT05838027|147487767|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.52|||||TWO_SIDED|95.0|-3.78|4.82||||||||4.82|-3.78|
73972866|NCT05838027|147487768|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.01|1.4||||||||1.40|-1.01|
73972867|NCT05838027|147487769|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-2.71|||||TWO_SIDED|95.0|-7.43|2.0||||||||2.00|-7.43|
73972868|NCT05838027|147487770|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.65|||||TWO_SIDED|95.0|-5.45|4.16||||||||4.16|-5.45|
73972869|NCT05838027|147487771|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|IRR|1.12|||||TWO_SIDED|95.0|0.46|2.74||||||||2.74|0.46|
73935922|NCT00489970|147401675|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response|-4.76|||||TWO_SIDED|97.5|-14.53|3.18|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.||3.18|-14.53|
73935923|NCT01159938|147401714|SUPERIORITY_OR_OTHER||LS mean difference|0.26||||0.617|TWO_SIDED|95.0|-0.78|1.3||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.30|-0.78|0.617
73935924|NCT01159938|147401714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.732|TWO_SIDED|95.0|-1.23|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.73|-1.23|0.732
73935925|NCT01159938|147401714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.715|TWO_SIDED|95.0|-1.2|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.73|-1.20|0.715
73935926|NCT01159938|147401714|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35||||0.177|TWO_SIDED|95.0|-0.85|0.16||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||0.16|-0.85|0.177
73935927|NCT01159938|147401714|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.579|TWO_SIDED|95.0|-0.94|0.53||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.53|-0.94|0.579
73935928|NCT01159938|147401714|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49||||0.167|TWO_SIDED|95.0|-1.19|0.21||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||0.21|-1.19|0.167
73935929|NCT01159938|147401715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.676|TWO_SIDED|95.0|-1.1|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.72|-1.10|0.676
73935930|NCT01159938|147401715|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.957|TWO_SIDED|95.0|-1.27|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.34|-1.27|0.957
73935931|NCT01159938|147401715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.513|TWO_SIDED|95.0|-1.68|0.85||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.85|-1.68|0.513
73935932|NCT01159938|147401715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.623|TWO_SIDED|95.0|-0.47|0.28||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.28|-0.47|0.623
73935933|NCT01159938|147401715|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.916|TWO_SIDED|95.0|-0.51|0.57||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.57|-0.51|0.916
74030511|NCT00390780|147615283|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.9033|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|||-0.15|0.9033
74030512|NCT00390780|147615284|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for ITT population.|difference in proportion mycologic cure|0.15||||0.5816|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Chi-squared||||||-0.15|0.5816
73935934|NCT01159938|147401715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.413|TWO_SIDED|95.0|-0.73|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-0.73|0.413
73935935|NCT01159938|147401716|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.724|TWO_SIDED|95.0|-0.94|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.34|-0.94|0.724
73935936|NCT01159938|147401716|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.479|TWO_SIDED|95.0|-1.05|2.2||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||2.20|-1.05|0.479
73935937|NCT01159938|147401716|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18||||0.825|TWO_SIDED|95.0|-1.76|1.41||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||1.41|-1.76|0.825
73935938|NCT01159938|147401716|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.378|TWO_SIDED|95.0|-0.65|0.25||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.25|-0.65|0.378
73935939|NCT01159938|147401716|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.553|TWO_SIDED|95.0|-0.84|0.46||The p-value is for the LS mean difference (high minus low postprandial glucose) in PWV at 120 mins post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.46|-0.84|0.553
74030513|NCT00390780|147615284|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for PP population|difference in proportion mycologic cure|0.15||||0.4439|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Chi-squared||||||-0.15|0.4439
73935940|NCT01159938|147401716|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.512|TWO_SIDED|95.0|-0.83|0.42||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.42|-0.83|0.512
73935941|NCT01159938|147401717|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.466|TWO_SIDED|95.0|-1.09|0.51||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.51|-1.09|0.466
73935942|NCT01159938|147401717|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44||||0.449|TWO_SIDED|95.0|-1.6|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.72|-1.60|0.449
73935943|NCT01159938|147401717|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.792|TWO_SIDED|95.0|-1.25|0.96||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.96|-1.25|0.792
73935944|NCT01159938|147401717|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16||||0.493|TWO_SIDED|95.0|-0.63|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-0.63|0.493
73935945|NCT01159938|147401717|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.091|TWO_SIDED|95.0|-1.25|0.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.10|-1.25|0.091
73935946|NCT01159938|147401717|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.425|TWO_SIDED|95.0|-0.39|0.9||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.90|-0.39|0.425
73935947|NCT01159938|147401718|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.275|TWO_SIDED|95.0|-1.36|0.4||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.40|-1.36|0.275
73972870|NCT05838027|147487772|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.75|||||TWO_SIDED|95.0|-1.29|-0.21||||||||-0.21|-1.29|
74030514|NCT00390780|147615285|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for ITT population.|difference in proportion relapsed|0.15||||0.833|ONE_SIDED|95.0|-0.15|||Significance level is \<0.025.|Chi-squared||||||-0.15|0.8330
73935948|NCT01159938|147401718|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.784||95.0|-1.44|1.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.10|-1.44|0.784
73935949|NCT01159938|147401718|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79||||0.197|TWO_SIDED|95.0|-2.01|0.43||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.43|-2.01|0.197
73935950|NCT01159938|147401718|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.122|TWO_SIDED|95.0|-0.9|0.11||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.11|-0.90|0.122
73935951|NCT01159938|147401718|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43||||0.246|TWO_SIDED|95.0|-1.16|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-1.16|0.246
73935952|NCT01159938|147401718|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37||||0.298|TWO_SIDED|95.0|-1.06|0.33||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.33|-1.06|0.298
73935953|NCT01159938|147401719|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.49||||0.024|TWO_SIDED|95.0|-6.5|-0.48||P-value is for the Least Square (LS) mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.||||-0.48|-6.50|0.024
73935954|NCT01159938|147401719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.859|TWO_SIDED|95.0|-2.59|3.09||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|The LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||3.09|-2.59|0.859
73972871|NCT05838027|147487775|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.57|||||TWO_SIDED|95.0|-1.9|3.03||||||||3.03|-1.90|
74030515|NCT00390780|147615285|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for PP population.|difference in proportion relapsed|0.15||||0.9738|ONE_SIDED|95.0|-0.15|||Significance level is \<0.025.|Chi-squared||||||-0.15|0.9738
73935955|NCT01159938|147401719|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.19||||0.155|TWO_SIDED|95.0|-5.25|0.87||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.87|-5.25|0.155
74030516|NCT00390780|147615290|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis for Clotrimazole minimum inhibitory concentration (MIC) between treatment groups||||0.1860
74030517|NCT00390780|147615290|SUPERIORITY_OR_OTHER|||||||0.9564||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis for Miconazole minimum inhibitory concentration (MIC) between treatment groups||||0.9564
73935956|NCT01159938|147401719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.685|TWO_SIDED|95.0|-3.46|2.3||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||2.30|-3.46|0.685
73935957|NCT01159938|147401719|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.84||||0.292|TWO_SIDED|95.0|-5.33|1.64||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||1.64|-5.33|0.292
73935958|NCT01159938|147401719|SUPERIORITY_OR_OTHER||LS Mean Difference|2.04||||0.216|TWO_SIDED|95.0|-1.25|5.33||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||5.33|-1.25|0.216
73935959|NCT01159938|147401719|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.87||||0.065|TWO_SIDED|95.0|-5.92|0.18||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.18|-5.92|0.065
73935960|NCT01159938|147401719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.954|TWO_SIDED|95.0|-2.96|2.8||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||2.80|-2.96|0.954
73935961|NCT01159938|147401720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.905|TWO_SIDED|95.0|-0.31|0.27||P-value is for Least Square (LS) mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.27|-0.31|0.905
73935962|NCT01159938|147401720|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.004|TWO_SIDED|95.0|0.14|0.69||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.69|0.14|0.004
73935963|NCT01159938|147401720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.584|TWO_SIDED|95.0|-0.41|0.23||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.23|-0.41|0.584
73935964|NCT01159938|147401720|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.436|TWO_SIDED|95.0|-0.19|0.44||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.44|-0.19|0.436
73935965|NCT00086346|147401730|SUPERIORITY_OR_OTHER|||||||0.342|||||||Rank ANCOVA|||||||0.342
73935966|NCT00086346|147401731|SUPERIORITY_OR_OTHER|||||||0.017|||||||Cochran-Mantel-Haenszel|||Comparison between treatment groups of percentages of patients with biopsy-confirmed acute rejection.||||0.017
73935967|NCT00086346|147401732|SUPERIORITY_OR_OTHER||||||>|0.05|||||||1 way ANOVA, two sided|||||||>0.05
73935968|NCT00086346|147401733|NON_INFERIORITY_OR_EQUIVALENCE|The a priori criterion for declaring non-inferiority was a lower bound of the 95% confidence interval (CI) having a ≥ 5% difference in graft loss. -5.2 is \< 5 % difference.|Mean Difference (Net)|-1.2||||||95.0|-5.2|2.8|||||Weighted difference in percentage of graft loss: (CNI% minus SRL%); negative values are favorable to CNI group|||2.8|-5.2|
73935969|NCT01303627|147401740|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Statistical analyses were performed x2 test or Mann Whitney U test as approriate. A p value of \<0.05 was considered statistically significant.|Chi-squared|||The incidence of complications on removal of the cLMA has been reported 54 % in awake patients group A power analysis indicated that a minimum 16 patients in each group were required to demonstrate a difference that 50% reduction the complications (a power of 80% and α error 0.05).||||<0.05
73935970|NCT01054820|147401759|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||Null hypothesis: no change from baseline. Study powered at 95 percent (%) to detect a mean change of at least 1.2 units, with assumed standard deviation of at most 3.2 units.||||<0.0001
73935971|NCT01054820|147401760|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|McNemar|||||||<0.0001
73935972|NCT01054820|147401761|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
73972872|NCT05838027|147487776|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.32|0.58||||||||0.58|-0.32|
73935973|NCT01054820|147401762|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
73935974|NCT01054820|147401763|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
73935975|NCT01054820|147401764|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
73972873|NCT05838027|147487777|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|IRR|0.62|||||TWO_SIDED|95.0|0.23|1.63||||||||1.63|0.23|
73935976|NCT01054820|147401767|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
73935977|NCT00996996|147401773|SUPERIORITY_OR_OTHER||Percentage of participants|95.0|||||TWO_SIDED|95.0|90.0|100.0|||||The estimated value represents the percentage of participants with a confirmed response.|||100|90|
73972874|NCT05838027|147487778|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|1.05|||||TWO_SIDED|95.0|-0.54|2.64||||||||2.64|-0.54|
73972875|NCT05838027|147487779|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.19|5.49||||||||5.49|0.19|
73972876|NCT05838027|147487780|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-2.64|0.43||||||||0.43|-2.64|
73972877|NCT05838027|147487781|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|2.72|||||TWO_SIDED|95.0|-1.35|6.8||||||||6.80|-1.35|
73972878|NCT05838027|147487782|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.69|||||TWO_SIDED|95.0|-1.74|0.36||||||||0.36|-1.74|
73972879|NCT03331835|147487800|SUPERIORITY||Risk Difference (RD)|42.86|||<|0.001|TWO_SIDED|95.0|30.93|54.79|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, \> 100 kg).||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||54.79|30.93|<0.001
73972880|NCT03331835|147487801|SUPERIORITY||Risk Difference (RD)|44.76|||<|0.001|TWO_SIDED|95.0|32.81|56.71|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, \> 100 kg)||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||56.71|32.81|<0.001
73972881|NCT03331835|147487802|SUPERIORITY||Risk Difference (RD)|43.81|||<|0.001|TWO_SIDED|95.0|31.78|55.84|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||55.84|31.78|<0.001
73972882|NCT03331835|147487803|SUPERIORITY||Risk Difference (RD)|31.43|||<|0.001|TWO_SIDED|95.0|20.76|42.1|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||42.10|20.76|<0.001
73972883|NCT03331835|147487804|SUPERIORITY||Mean Difference (Net)|-3.08|||<|0.001|TWO_SIDED|95.0|-4.83|-1.33|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-1.33|-4.83|<0.001
73972884|NCT03331835|147487805|SUPERIORITY||Mean Difference (Net)|-16.36|||<|0.001|TWO_SIDED|95.0|-23.03|-9.68|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-9.68|-23.03|<0.001
73972885|NCT03331835|147487806|SUPERIORITY||Mean Difference (Net)|-8.91|||<|0.001|TWO_SIDED|95.0|-13.0|-4.81|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-4.81|-13.00|<0.001
73972886|NCT03331835|147487810|SUPERIORITY||Mean Difference (Final Values)|-4.92|||<|0.001|TWO_SIDED|95.0|-6.31|-3.53|||ANCOVA|||The AUC was analysed using analysis of covariance (ANCOVA) with treatment group, baseline weight group, and the baseline PSI total score as explanatory variables. Treatment groups are defined as randomised treatment.||-3.53|-6.31|<0.001
74030518|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.0126|TWO_SIDED|95.0|0.833|0.978|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.978|0.833|0.0126
73935978|NCT00996996|147401774|SUPERIORITY_OR_OTHER||Percentage of participants|97.0|||||TWO_SIDED|95.0|94.0|100.0|||||The estimated value represents the percentage of participants with a response.|||100|94|
73935979|NCT00996996|147401775|SUPERIORITY_OR_OTHER||Percentage of participants|70.0|||||TWO_SIDED|95.0|59.0|80.0|||||The estimated value represents the percentage of participants with a confirmed CR.|||80|59|
73935980|NCT00996996|147401775|SUPERIORITY_OR_OTHER||Percentage of participants|3.0|||||TWO_SIDED|95.0|0.0|6.0|||||The estimated value represents the percentage of participants with a confirmed CCR.|||6|0|
73935981|NCT00996996|147401775|SUPERIORITY_OR_OTHER||Percentage of participants|75.0|||||TWO_SIDED|95.0|65.0|85.0|||||The estimated value represents the percentage of participants with confirmed CR + confirmed CCR.|||85|65|
73935982|NCT00996996|147401775|SUPERIORITY_OR_OTHER||Percentage of participants|17.0|||||TWO_SIDED|95.0|9.0|26.0|||||The estimated value represents the percentage of participants with a confirmed PR.|||26|9|
73935983|NCT00996996|147401776|SUPERIORITY_OR_OTHER||Percentage of participants|74.0|||||TWO_SIDED|95.0|64.0|84.0|||||The estimated value represents the percentage of participants with a CR.|||84|64|
73935984|NCT00996996|147401776|SUPERIORITY_OR_OTHER||Percentage of participants|4.0|||||TWO_SIDED|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with a CCR.|||8|0|
73935985|NCT00996996|147401776|SUPERIORITY_OR_OTHER||Percentage of participants|78.0|||||TWO_SIDED|95.0|68.0|87.0|||||The estimated value represents the percentage of participants with a CR + CCR.|||87|68|
73935986|NCT00996996|147401776|SUPERIORITY_OR_OTHER||Percentage of participants|20.0|||||TWO_SIDED|95.0|11.0|29.0|||||The estimated value represents the percentage of participants with a PR.|||29|11|
73972887|NCT03331835|147487811|SUPERIORITY||Mean Difference (Net)|-2.57||||0.004|TWO_SIDED|95.0|-4.32|-0.82|||Mixed Models Analysis|||The endpoint is analysed by using mixed model for repeated measurements (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups are defined as randomised treatment.||-0.82|-4.32|0.004
73972888|NCT03331835|147487812|SUPERIORITY|Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (\<=100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.|Risk Difference (RD)|40.95|||<|0.001|TWO_SIDED|95.0|28.75|53.16|||Cochran-Mantel-Haenszel|||||53.16|28.75|<0.001
74008327|NCT03627767|147566502|SUPERIORITY||LSM difference|-1.2|||||TWO_SIDED|95.0|-2.1|-0.3||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-2.1|
74030519|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.966||||0.0042|TWO_SIDED|95.0|0.944|0.989|||Regression, Logistic|||The statistical analysis is presented for Body Mass Index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.989|0.944|0.0042
74008328|NCT03627767|147566502|SUPERIORITY||LSM difference|-1.9|||=|0.015|TWO_SIDED|95.0|-3.5|-0.4|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-3.5|= 0.0150
74008329|NCT03627767|147566502|SUPERIORITY||LSM difference|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.7|-1.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-4.7|< 0.0001
74008330|NCT03627767|147566502|SUPERIORITY||LSM difference|-1.3|||||TWO_SIDED|95.0|-2.3|-0.3||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-2.3|
73935987|NCT04535037|147401824|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) of group GMC ratio (Infanrix Hexa over Vaxelis group) was above 0.5.|Adjusted GMC Ratio|0.917|||||TWO_SIDED|95.0|0.71|1.185||||The 95% CI for GMC ratio derived from an ANOVA model on log10 transformed concentration was used. GMC was adjusted for DTPA vaccination of the mother.||To demonstrate that the Haemophilus influenzae type b(Hib) response of Infanrix Hexa Group is non-inferior to the Vaxelis Group in terms of anti-PRP GMCs, 1 month post-booster vaccination.||1.185|0.710|
73935988|NCT04535037|147401825|NON_INFERIORITY|Non-inferiority was demonstrated if the non inferiority of anti-PRP GMC ratio was met and the LL of the 2 sided 95% CI on group difference in the percentage (Infanrix Hexa over Vaxelis group) was more than -10%.|Difference in Percentage|-6.3|||||TWO_SIDED|95.0|-14.1|1.49||||The 2 sided 95% CI of group difference in seroconversion rate (Inv\_group minus Com\_group) was computed based on Miettinen and Nurminen method.||To demonstrate that the Hib response in Infanrix Hexa group is non-inferior to Vaxelis Group in terms of percentage of subjects with anti-PRP antibody concentrations ≥ 5 µg/mL, 1 month post-booster vaccination.||1.49|-14.10|
73935989|NCT02031276|147401833|OTHER||difference in percentage of participants|12.6||||0.0955|TWO_SIDED|95.0|-2.2|27.5|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-tumor necrosis factor (anti-TNF) exposure.||27.5|-2.2|0.0955
73935990|NCT02031276|147401834|OTHER||difference in percentage of participants|13.4||||0.1151|TWO_SIDED|95.0|-3.3|30.1|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||30.1|-3.3|0.1151
73935991|NCT02031276|147401835|OTHER||difference in percentage of participants|12.0||||0.0057|TWO_SIDED|95.0|3.5|20.6|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||20.6|3.5|0.0057
74008331|NCT03627767|147566502|SUPERIORITY||LSM difference|-0.8|||=|0.3616|TWO_SIDED|95.0|-2.4|0.9|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.9|-2.4|= 0.3616
73935992|NCT02031276|147401836|OTHER||difference in percentage of participants|18.7||||0.0104|TWO_SIDED|95.0|4.4|33.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||33.0|4.4|0.0104
73935993|NCT02031276|147401837|OTHER||difference in percentage of participants|2.4||||0.4977|TWO_SIDED|95.0|-4.5|9.2|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||9.2|-4.5|0.4977
73935994|NCT02031276|147401838|OTHER||difference in percentage of participants|7.4||||0.0107|TWO_SIDED|95.0|1.7|13.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||13.0|1.7|0.0107
73935995|NCT01148810|147401839|SUPERIORITY_OR_OTHER||Bayesian analysis|0.96|||||||||||||||Probability that the difference (BAF312-Placebo) is greater than the threshold|||
73935996|NCT02165722|147401850|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.||||||<0.001
73935997|NCT02165722|147401850|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.||||||<0.001
73935998|NCT02165722|147401850|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.||||<0.001
73935999|NCT02165722|147401850|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||<0.001
73972889|NCT03331835|147487813|SUPERIORITY|The endpoint was analysed by using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.|Mean Difference (Net)|-1.72||||0.028|TWO_SIDED|95.0|-3.24|-0.19|||Mixed Models Analysis|||||-0.19|-3.24|0.028
73972890|NCT06029452|147487829|NON_INFERIORITY|Non-inferiority margin was 0.10.|Sensitivity|0.853|||||ONE_SIDED|95.0|0.815||||||Sensitivity was defined as the probability that an individual with the disease in the population were screen positive for disease by the algorithm (TP). Sensitivity = TP / (TP + FN).||||0.815|
73972891|NCT06029452|147487829|NON_INFERIORITY|Non-inferiority margin was 0.10.|Specificity|0.584|||||ONE_SIDED|95.0|0.539||||||Sensitivity was defined as the probability that an individual with the disease in the population were screen positive for disease by the algorithm (TP). Sensitivity = TP / (TP + FN).||||0.539|
73972892|NCT03314740|147487893|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.265|TWO_SIDED|90.0|0.5|1.14|||cox model|||||1.14|0.5|0.265
73972893|NCT03314740|147487893|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.904|TWO_SIDED|90.0|0.68|1.55|||cox- model|||||1.55|0.68|0.904
73936000|NCT02165722|147401851|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.||||||0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.||||||0.001
73936001|NCT02165722|147401851|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
73972894|NCT04011644|147487959|SUPERIORITY|||||||0.688|||||||Mixed Models Analysis|Quanbeck,A.et al. A randomized trial testing digital medicine support models for mild-to-moderate alcohol use disorder. npj Digit. Med.7,248(2024)||||||0.688
73972895|NCT04011644|147487960|SUPERIORITY|||||||0.261|||||||Mixed Models Analysis|||||||0.261
73972896|NCT04011644|147487961|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||0.014
73972897|NCT04011644|147487963|SUPERIORITY|||||||0.908|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.908
73972898|NCT04011644|147487965|SUPERIORITY|||||||0.206|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.206
73936002|NCT02165722|147401851|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
73936003|NCT02165722|147401851|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
73972899|NCT04011644|147487966|SUPERIORITY|||||||0.104|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.104
73972900|NCT04011644|147487967|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73972901|NCT04011644|147487968|SUPERIORITY|||||||0.025|||||||Mixed Models Analysis|||||||0.025
73972902|NCT04011644|147487969|SUPERIORITY|||||||0.555|||||||Mixed Models Analysis|||||||0.555
73936004|NCT02417246|147401885|EQUIVALENCE|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have \>80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|45.1|STANDARD_DEVIATION|222.2||0.3|TWO_SIDED|95.0|-41.1|131.2|||t-test, 2 sided|Average AUC from 0 to 24 hours (0-24) for patients on the 50mg dose of brand name metoprolol ER and Generic B were compared by a paired t-test (n=28)||||131.2|-41.1|0.3
73936005|NCT02417246|147401885|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic B to brand name metoprolol ER falls within 0.8 to 1.25|Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.95||The analysis included a total of 20 patients on Generic B and brand name metoprolol ER, which is less than the initial plan of including 38 patients.||||||0.95|0.76|
73936006|NCT02417246|147401885|EQUIVALENCE|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have \>80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|176.5||0.8|TWO_SIDED|95.0|-60.0|74.3|||t-test, 2 sided|Average AUC0-24 for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)||||74.3|-60.0|0.8
73936007|NCT02417246|147401885|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.86|1.01||This analysis included 21 individuals who were administered brand name metoprolol ER and Generic A, which is less than the initial plan of including 38 patients.||||||1.01|0.86|
73936008|NCT02417246|147401886|EQUIVALENCE|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have \>80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|10.7||0.2|TWO_SIDED|95.0|-1.5|6.6|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic B were compared using a paired t-test (n=29)||||6.6|-1.5|0.2
73936009|NCT02417246|147401886|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic B to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.79|0.95||The analysis included a total of 29 patients on Generic B and brand name metoprolol ER, which is less than the initial plan of including 38 patients||||||0.95|0.79|
73936010|NCT02417246|147401886|EQUIVALENCE|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have \>80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|12.6||0.3|TWO_SIDED|95.0|-7.3|2.3|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)||||2.3|-7.3|0.3
73936011|NCT02417246|147401886|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|1.12|||||TWO_SIDED|90.0|1.02|1.23||The analysis included a total of 29 patients on Generic A and brand name metoprolol ER, which is less than a pre-planned sample size of 38.||||||1.23|1.02|
73936012|NCT02417246|147401887|EQUIVALENCE|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic B, adjusting for quartile, (quartile\*med) interaction, and treatment assignment.|Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0858|TWO_SIDED||||||Mixed Models Analysis|||||||0.0858
74030520|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.732|||<|0.0001|TWO_SIDED|95.0|0.656|0.816|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at Baseline (BL) in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.816|0.656|<0.0001
74030521|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.686|||<|0.0001|TWO_SIDED|95.0|1.347|2.109|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.109|1.347|<0.0001
73936013|NCT02417246|147401887|EQUIVALENCE|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic A, adjusting for quartile,(quartile\*med) interaction, and treatment assignment.|Slope|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0168|TWO_SIDED||||||Mixed Models Analysis||p for medication\*quartile interaction considered significant if p\<0.025.|||||0.0168
73936014|NCT02417246|147401888|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory systolic blood pressure (SBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-2.39||||0.203|TWO_SIDED||||||Mixed Models Analysis|||||||0.203
73936015|NCT02417246|147401888|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory diastolic blood pressure (DBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-0.543||||0.671|TWO_SIDED||||||Mixed Models Analysis|||||||0.671
73936016|NCT02417246|147401888|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory SBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.371||||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.200
73936017|NCT02417246|147401888|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory DBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.329||||0.068|TWO_SIDED||||||Mixed Models Analysis|||||||0.068
73936018|NCT02417246|147401889|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|1.233||||0.333|TWO_SIDED||||||Mixed Models Analysis|||||||0.333
73936019|NCT02417246|147401889|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|1.134||||0.368|TWO_SIDED||||||Mixed Models Analysis|||||||0.368
73936020|NCT04321460|147401897|SUPERIORITY||Odds Ratio (OR)|4.564||||0.007|TWO_SIDED|95.0|1.66|16.039|||Wilcoxon (Mann-Whitney)|||||16.039|1.66|0.007
73936021|NCT04321460|147401898|SUPERIORITY||Odds Ratio (OR)|4.716||||0.002|TWO_SIDED|95.0|1.898|14.268|||Wilcoxon (Mann-Whitney)|||||14.268|1.898|0.002
73936022|NCT04495712|147401911|SUPERIORITY|||||||0.71|||||||Log Rank|||||||0.71
73936023|NCT04495712|147401912|SUPERIORITY|||||||0.07|||||||Log Rank|||||||0.07
73936024|NCT04495712|147401913|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
73936025|NCT01308749|147401917|OTHER||||||||||||||||||No analyses were completed, this is descriptive only and is an absolute value (number of participants).|||
73936026|NCT01308749|147401921|EQUIVALENCE|Within group test of difference using t-scores adjusted by baseline score, no correction for multiple comparisons, nonparametric model||||||0.023|||||||t-test, 2 sided|||||||0.023
73936027|NCT01308749|147401923|EQUIVALENCE|t-test between groups||||||0.23|||||||t-test, 2 sided|no adjustment for multiple comparison. non parametric||||||0.23
73972903|NCT04011644|147487970|SUPERIORITY|||||||0.131|||||||Kruskal-Wallis|||||||0.131
73972904|NCT04011644|147487974|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
73972905|NCT02997202|147487978|SUPERIORITY||Hazard Ratio (HR)|0.679||||0.0518|TWO_SIDED|95.0|0.459|1.005|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.005|0.459|0.0518
73936028|NCT02079805|147401936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||||TWO_SIDED|95.0|-0.89|1.78||||||Telmisartan 40 mg, Azilsartan 20 mg||1.78|-0.89|
73936029|NCT00856583|147402043|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 90% confidence interval (CI) for the estimated all-cause mortality ratio was \<1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 patient years of exposure (PYE) were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|1.117||||0.05|TWO_SIDED|90.0|0.831|1.5|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the WRT+30 days period.||1.500|0.831|0.05
73936030|NCT00856583|147402043|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 90% CI for the estimated all-cause mortality ratio was \<1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 PYE were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|0.98|||<|0.05|TWO_SIDED|90.0|0.684|1.405|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the ORT period.||1.405|0.684|<0.05
73936031|NCT00856583|147402044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.84||||0.0022|TWO_SIDED|95.0|1.45|5.55|||Cox Proportional Hazard|Adjusted: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), region, year since start of enrollment||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||5.55|1.45|0.0022
73936032|NCT00856583|147402045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73||||0.29|TWO_SIDED|95.0|0.63|4.78|||Cox Proportional Hazard|Adjusted for: age and sex.||The basis for the statistical analysis of time to 1st occurence of the secondary primary outcome (one patient in the risperidone group reported more than one occurrence of this event) was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||4.78|0.63|0.29
73936033|NCT00856583|147402046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.34|TWO_SIDED|95.0|0.36|1.41|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.41|0.36|0.34
73936034|NCT00856583|147402047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.26|TWO_SIDED|95.0|0.4|1.28|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.28|0.40|0.26
73936035|NCT00856583|147402048|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.13||||0.081|TWO_SIDED|95.0|0.91|4.98|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy).||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||4.98|0.91|0.081
73972906|NCT02997202|147487979|SUPERIORITY||Hazard Ratio (HR)|0.846||||0.4394|TWO_SIDED|95.0|0.554|1.293|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.293|0.554|0.4394
73936036|NCT00856583|147402049|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.24|TWO_SIDED|95.0|0.33|1.32|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.32|0.33|0.24
73936037|NCT00856583|147402050|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.59|TWO_SIDED|95.0|0.7|1.85|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.85|0.70|0.59
73936038|NCT00856583|147402051|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.65|TWO_SIDED|95.0|0.66|1.29|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.29|0.66|0.65
73936039|NCT00856583|147402052|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.044|TWO_SIDED|95.0|0.45|0.99|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||0.99|0.45|0.044
73936040|NCT00856583|147402053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.04|TWO_SIDED|95.0|1.01|1.57|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.57|1.01|0.040
73936041|NCT00856583|147402054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.28|1.43|||Cox Proportional Hazard|Adjusted: disease duration, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.43|1.28|<0.0001
73936042|NCT00823082|147402058|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73936043|NCT00823082|147402059|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
73972907|NCT02997202|147487982|SUPERIORITY||Hazard Ratio (HR)|2.308||||0.0209|TWO_SIDED|95.0|1.1352|4.6922|||Fine-Grays Model|||Based on Fine \& Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||4.6922|1.1352|0.0209
73972908|NCT02997202|147487983|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6417|TWO_SIDED|95.0|0.686|1.261|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.261|0.686|0.6417
73972909|NCT02997202|147487984|SUPERIORITY||Hazard Ratio (HR)|0.8938||||0.641|TWO_SIDED|95.0|0.5574|1.433|||Fine-Grays model|||"aGVHD II to IV:~Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate."||1.4330|0.5574|0.6410
73972910|NCT02997202|147487984|SUPERIORITY||Hazard Ratio (HR)|1.4254||||0.4128|TWO_SIDED|95.0|0.6103|3.3289|||Fine-Grays model|||"aGVHD III to IV:~Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate."||3.3289|0.6103|0.4128
73972911|NCT02997202|147487985|SUPERIORITY||Hazard Ratio (HR)|1.236||||0.1725|TWO_SIDED|95.0|0.9116|1.6757|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||1.6757|0.9116|0.1725
73936044|NCT00823082|147402060|SUPERIORITY_OR_OTHER|||||||0.6115|TWO_SIDED||||||Fisher Exact|||At ICU discharge visit||||0.6115
73936045|NCT00823082|147402061|SUPERIORITY_OR_OTHER|||||||0.1211|TWO_SIDED||||||Fisher Exact|||Follow-up visit||||0.1211
73936046|NCT00823082|147402061|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||1.000
73936047|NCT00823082|147402062|SUPERIORITY_OR_OTHER|||||||0.487|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||0.4870
73936048|NCT00823082|147402063|SUPERIORITY_OR_OTHER|||||||0.3897|TWO_SIDED||||||Hodges-Lehmann test|||||||0.3897
73936049|NCT00823082|147402064|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
73936050|NCT00823082|147402065|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Fisher Exact|||||||0.0004
73936051|NCT00823082|147402066|SUPERIORITY_OR_OTHER|||||||0.0209|TWO_SIDED||||||ANCOVA|||||||0.0209
73936052|NCT00823082|147402067|SUPERIORITY_OR_OTHER|||||||0.7433|TWO_SIDED||||||ANCOVA|||Number of units of packed red blood cells||||0.7433
73936053|NCT00823082|147402067|SUPERIORITY_OR_OTHER|||||||0.7453|TWO_SIDED||||||ANCOVA|||Units of fresh frozen plasma||||0.7453
73936054|NCT00823082|147402067|SUPERIORITY_OR_OTHER|||||||0.2705|TWO_SIDED||||||ANCOVA|||Units of platelets||||0.2705
73936055|NCT00823082|147402068|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Fisher Exact|||||||0.4460
73936056|NCT00823082|147402069|SUPERIORITY_OR_OTHER|||||||0.4936|TWO_SIDED||||||Fisher Exact|||||||0.4936
73936057|NCT00823082|147402070|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Follow-up visit||||1.000
73936058|NCT00823082|147402070|SUPERIORITY_OR_OTHER|||||||0.6218|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||0.6218
73936059|NCT00823082|147402071|SUPERIORITY_OR_OTHER|||||||0.9574|TWO_SIDED||||||Hodges-Lehmann|||||||0.9574
73936060|NCT00823082|147402072|SUPERIORITY_OR_OTHER|||||||0.7489|||||||Hodges-Lehmann test|||||||0.7489
73936061|NCT02328326|147402073|SUPERIORITY||Mean Difference (Net)|2.6||||0.048|TWO_SIDED|95.0|0.02|5.18|||Regression, Linear|Model was adjusted for baseline value of PAM, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAM is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAM score compared to patient participants in PACT.||5.18|0.02|0.048
73936062|NCT02328326|147402074|SUPERIORITY||Mean Difference (Net)|0.9||||0.32|TWO_SIDED|95.0|-0.87|2.67|||Regression, Linear|Model adjusted for baseline value of ukpds, insulin use, site, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline. Reference for comparison is PACT.|The null hypothesis was that change (baseline to 12 months) in ukpds 5 year risk score is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' 5-year cardiovascular event risk.||2.67|-0.87|0.32
73936063|NCT02328326|147402075|SUPERIORITY||Mean Difference (Net)|0.71||||0.01|TWO_SIDED|95.0|0.2|1.22|||Regression, Linear|Model adjusted for BL value of Healthy Eating, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Healthy Eating is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' Healthy Eating scores compared to patient participants in PACT.||1.22|0.20|0.01
73936064|NCT02328326|147402076|SUPERIORITY||Mean Difference (Net)|0.17||||0.33|TWO_SIDED|95.0|-0.17|0.51|||Regression, Linear|Model was adjusted for baseline value of A1c, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in A1c is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' A1c score compared to patient participants in PACT.||0.51|-0.17|0.33
73936065|NCT02328326|147402077|SUPERIORITY||Mean Difference (Net)|-2.82||||0.18|TWO_SIDED|95.0|-7.0|1.35|||Regression, Linear|Model was adjusted for baseline value of SBP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in SBP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' SBP score compared to patient participants in PACT.||1.35|-7.00|0.18
73936066|NCT02328326|147402078|SUPERIORITY||Mean Difference (Net)|0.12||||0.83|TWO_SIDED|95.0|-0.95|1.19|||Regression, Linear|Model was adjusted for baseline value of PAID, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAID is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID score compared to patient participants in PACT.||1.19|-0.95|0.83
73936067|NCT02328326|147402079|SUPERIORITY||Mean Difference (Net)|0.11||||0.79|TWO_SIDED|95.0|-0.71|0.93|||Regression, Linear|Model was adjusted for baseline value of PEPPI, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PEPPI is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PEPPI score compared to patient participants in PACT.||0.93|-0.71|0.79
73936068|NCT02328326|147402080|SUPERIORITY||Median Difference (Net)|0.15||||0.21|TWO_SIDED|95.0|-0.09|0.4|||Regression, Linear|Model adjusted for BL value of Cho to HDL Ratio, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Chol to HDL Ratio is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' Chol to HDL Ratio score compared to patient participants in PACT.||0.40|-0.09|0.21
73936069|NCT02328326|147402082|SUPERIORITY||Mean Difference (Net)|0.3||||0.01|TWO_SIDED|95.0|0.08|0.53|||Regression, Linear|Model was adjusted for baseline value of IOCQ, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in IOCQ is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' IOCQ score compared to patient participants in PACT.||0.53|0.08|0.01
73936070|NCT02328326|147402083|EQUIVALENCE|Equivalent distribution among categories|difference in count|-1.0||||0.17|TWO_SIDED||||||Chi-squared||||Difference in count of those who stopped smoking in CO-IMPACT vs. those who stopped smoking in PACT.|||0.17
73972912|NCT02997202|147487986|SUPERIORITY||Hazard Ratio (HR)|1.236||||0.1725|TWO_SIDED|95.0|0.9116|1.6757|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||1.6757|0.9116|0.1725
73972913|NCT02997202|147487987|SUPERIORITY||Hazard Ratio (HR)|3.4537||||0.2029|TWO_SIDED|95.0|0.5126|23.2687|||Fine-Grays Model|||MRD Eradication||23.2687|0.5126|0.2029
73972914|NCT02997202|147487987|SUPERIORITY||Hazard Ratio (HR)|0.7073||||0.4077|TWO_SIDED|95.0|0.3116|1.6055|||Fine-Grays Model|||MRD 10\^-4 Detection||1.6055|0.3116|0.4077
73972915|NCT02997202|147487988|SUPERIORITY||Hazard Ratio (HR)|0.3729|||<|0.001|TWO_SIDED|95.0|0.2243|0.6199|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||0.6199|0.2243|<0.001
73972916|NCT02997202|147487989|SUPERIORITY||Hazard Ratio (HR)|1.4848||||0.0568|TWO_SIDED|95.0|0.9886|2.23|||Fine-Grays model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||2.2300|0.9886|0.0568
73866185|NCT04566601|147278607|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.4552|TWO_SIDED|95.0|-0.45|0.2||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.20|-0.45|0.4552
73866186|NCT04566601|147278607|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.4734|TWO_SIDED|95.0|-0.47|0.22||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.22|-0.47|0.4734
73866187|NCT04566601|147278607|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.03||||0.8388|TWO_SIDED|95.0|-0.36|0.29||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.29|-0.36|0.8388
73866188|NCT04566601|147278607|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.08||||0.554|TWO_SIDED|95.0|-0.35|0.19||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.19|-0.35|0.5540
73866189|NCT02277925|147278634|SUPERIORITY||Risk Ratio (RR)|1.74||||0.3|TWO_SIDED|95.0|0.59|5.14|||Chi-squared|||||5.14|0.59|0.30
73936071|NCT02328326|147402084|SUPERIORITY||Mean Difference (Net)|-0.04||||0.87|TWO_SIDED|95.0|-0.56|0.47|||Regression, Linear|Model adjusted for BL value of Physical Activity, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Physical activity is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Physical activity score compared to patient participants in PACT.||0.47|-0.56|0.87
73936072|NCT02328326|147402085|SUPERIORITY||Mean Difference (Net)|0.23||||0.31|TWO_SIDED|95.0|-0.22|0.68|||Regression, Linear|Model adjusted for BL value of Blood Sugar Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Blood Sugar Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Sugar Home Testing score compared to patient participants in PACT.||0.68|-0.22|0.31
73936073|NCT02328326|147402086|SUPERIORITY||Mean Difference (Net)|0.07||||0.87|TWO_SIDED|95.0|-0.76|0.89|||Regression, Linear|Model adjusted for BL value of Blood Pressure Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Blood Pressure Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Pressure Home Testing score compared to patient participants in PACT.||0.89|-0.76|0.87
73936074|NCT02328326|147402087|SUPERIORITY||Mean Difference (Net)|-0.1||||0.56|TWO_SIDED|95.0|-0.42|0.23|||Regression, Linear|Model adjusted for BL value of Take Oral Meds as Prescribed, insulin use, randomization strat variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Take Oral Meds as Prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Oral Meds as Prescribed score compared to patient participants in PACT.||0.23|-0.42|0.56
73972917|NCT01199133|147487990|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.01|||>|0.05||95.0|-0.41|0.43|||ANCOVA|||||0.43|-0.41|> 0.05
73972918|NCT05265065|147488009|NON_INFERIORITY|"Non-inferiority margin of -10% (absolute difference) and a one-sided significance level of 5%.~The sample size calculation assumed an estimated seroresponse rate of 95% in both half- and full-dose arms, a non- inferiority margin of -10% (absolute difference), a one-sided significance level of5%, and no loss to follow- up. Under this scenario, a sample size of 100 per arm provides 90% power to compare seroresponse rates between arms under the non-inferiority framework."|Risk Difference (RD)|-2.9|||||TWO_SIDED|95.0|-7.7|2.0|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|Non-inferiority margin of -10% (absolute difference) and a one-sided significance level of 5%.||2.0|-7.7|
73866190|NCT02277925|147278635|SUPERIORITY||Risk Ratio (RR)|1.03||||0.43|TWO_SIDED|95.0|0.96|1.11|||Chi-squared|||||1.11|0.96|0.43
73866191|NCT02277925|147278636|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.39|TWO_SIDED|95.0|-14.7|5.7|||t-test, 2 sided|||||5.7|-14.7|0.39
73866192|NCT00767806|147278638|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory 24-hour average pain score after 12 weeks of treatment.||||0.001
73936075|NCT02328326|147402088|SUPERIORITY||Mean Difference (Net)|0.07||||0.67|TWO_SIDED|95.0|-0.26|0.41|||Regression, Linear|Model adjusted for baseline value of Take Insulin as Prescribed, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Take Insulin as prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Insulin as Prescribed compared to patient participants in PACT.||0.41|-0.26|0.67
73936076|NCT02328326|147402089|SUPERIORITY|The null hypothesis was that change (baseline to 12 months) in Foot Care is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Foot Care score compared to patient participants in PACT.|Median Difference (Net)|0.26||||0.29|TWO_SIDED|95.0|-0.22|0.75|||Regression, Linear|Model was adjusted for baseline value of Foot Care, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|||Net difference defined as 12 months minus baseline|0.75|-0.22|0.29
73936077|NCT02328326|147402090|SUPERIORITY||Mean Difference (Net)|0.4||||0.01|TWO_SIDED|95.0|0.09|0.71|||Regression, Linear|Model was adjusted for baseline value of SE, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in SE is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' SE scores compared to patient participants in PACT.||0.71|0.09|0.01
73936078|NCT02328326|147402091|SUPERIORITY||Mean Difference (Net)|0.1||||0.67|TWO_SIDED|95.0|-0.34|0.55|||Regression, Linear|Model was adjusted for baseline value of Lorig\_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Lorig\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Lorig\_CP score compared to patient participants in PACT.||0.55|-0.34|0.67
73936079|NCT02328326|147402092|SUPERIORITY||Mean Difference (Net)|0.28||||0.53|TWO_SIDED|95.0|-0.6|1.16|||Regression, Linear||Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in CSIS is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' CSIS score compared to patient participants in PACT.||1.16|-0.60|0.53
73972919|NCT05265065|147488011|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-16.1|11.3|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||11.3|-16.1|
73936080|NCT02328326|147402093|SUPERIORITY||Mean Difference (Net)|0.32||||0.5|TWO_SIDED|95.0|-0.61|1.25|||Regression, Linear|Model was adjusted for baseline value of PAID\_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baselineNet difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAID\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID\_CP score compared to patient participants in PACT.||1.25|-0.61|0.50
73972920|NCT05265065|147488011|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-9.5|3.2|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||3.2|-9.5|
73866193|NCT00767806|147278639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.002|TWO_SIDED|95.0|-1.12|-0.25||P-value is for BPI severity of worst pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of worst pain score during 12 weeks of treatment.||-0.25|-1.12|0.002
73936081|NCT03452917|147402094|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.82|ONE_SIDED|95.0|-8.0||||Chi-squared||||||-8.0|0.82
73936082|NCT03452917|147402094|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.66|ONE_SIDED|95.0|-6.5||||Chi-squared||||||-6.5|0.66
73936083|NCT03452917|147402095|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.44|TWO_SIDED|95.0|-6.0|2.6|||Chi-squared|||||2.6|-6.0|0.44
73972921|NCT05265065|147488011|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-17.1|16.1|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||16.1|-17.1|
73972922|NCT05265065|147488012|SUPERIORITY||Geometric Mean Ratio|0.94||||0.228|TWO_SIDED|95.0|0.86|1.04|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.04|0.86|0.228
73972923|NCT05265065|147488013|SUPERIORITY||Geometric Mean Ratio|0.94||||0.537|TWO_SIDED|95.0|0.77|1.15|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.15|0.77|0.537
73936084|NCT03452917|147402095|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.85|TWO_SIDED|95.0|-4.9|4.0|||Chi-squared|||||4.0|-4.9|0.85
73936085|NCT03452917|147402096|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.12|TWO_SIDED|95.0|-0.9|5.4|||Wilcoxon (Mann-Whitney)|||||5.4|-0.9|0.12
73936086|NCT03452917|147402096|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.41|TWO_SIDED|95.0|-2.5|3.6|||Wilcoxon (Mann-Whitney)|||||3.6|-2.5|0.41
73972924|NCT05265065|147488013|SUPERIORITY||Geometric Mean Ratio|0.99||||0.922|TWO_SIDED|95.0|0.89|1.11|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.11|0.89|0.922
73866194|NCT00767806|147278639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.006|TWO_SIDED|95.0|-0.85|-0.14||P-value is for BPI severity of least pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of least pain score during 12 weeks of treatment.||-0.14|-0.85|0.006
73866195|NCT00767806|147278639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.001|TWO_SIDED|95.0|-1.25|-0.46||P-value is for BPI severity of pain right now - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of pain right now score during 12 weeks of treatment.||-0.46|-1.25|<0.001
73866196|NCT00767806|147278639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|||<|0.001|TWO_SIDED|95.0|-1.16|-0.35||P-value is for BPI interference with general activity - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with general activity score during 12 weeks of treatment.||-0.35|-1.16|<0.001
73936087|NCT03452917|147402097|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.42|TWO_SIDED|95.0|-8.3|3.5|||Chi-squared|||||3.5|-8.3|0.42
73866197|NCT00767806|147278639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.09|-0.34||P-value is for BPI interference with mood score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with mood score during 12 weeks of treatment.||-0.34|-1.09|<0.001
73936088|NCT03452917|147402097|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.49|TWO_SIDED|95.0|-8.0|3.9|||Chi-squared|||||3.9|-8.0|0.49
73936089|NCT03452917|147402098|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.93|TWO_SIDED|95.0|-7.8|8.6|||Chi-squared|||||8.6|-7.8|0.93
73936090|NCT03452917|147402098|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.2|TWO_SIDED|95.0|-2.8|13.3|||Chi-squared|||||13.3|-2.8|0.20
73936091|NCT03452917|147402099|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.5|TWO_SIDED|95.0|-7.7|3.8|||Chi-squared|||||3.8|-7.7|0.50
73936092|NCT03452917|147402099|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.48|TWO_SIDED|95.0|-7.8|3.7|||Chi-squared|||||3.7|-7.8|0.48
73866198|NCT00767806|147278639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.02|TWO_SIDED|95.0|-0.84|-0.07||P-value is for BPI interference with walking ability - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with walking ability score during 12 weeks of treatment.||-0.07|-0.84|0.020
73936093|NCT03452917|147402100|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.49|TWO_SIDED|95.0|-6.0|2.6|||Chi-squared|||||2.6|-6.0|0.49
73936094|NCT03452917|147402100|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.85|TWO_SIDED|95.0|-4.9|4.0|||Chi-squared|||||4.0|-4.9|0.85
73936095|NCT03198000|147402101|EQUIVALENCE|Prespecified equivalence interval of (-0.22, 0.44).|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.049||0.392|TWO_SIDED|95.0|-0.14|0.055|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.055|-0.140|0.392
73936096|NCT03198000|147402101|EQUIVALENCE|Prespecified equivalence interval of (-0.22, 0.44)|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.049||0.828|TWO_SIDED|95.0|-0.086|0.107|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.107|-0.086|0.828
73936097|NCT03198000|147402102|EQUIVALENCE|Prespecified equivalence interval of (0.80, 1.25).|Odds Ratio (OR)|0.87||||0.576|TWO_SIDED|95.0|0.539|1.411|||GEE model|GEE model with treatment as factor.||||1.411|0.539|0.576
73936098|NCT03198000|147402102|EQUIVALENCE|Prespecified equivalence interval of (0.80, 1.25)|Odds Ratio (OR)|0.87||||0.544|TWO_SIDED|95.0|0.552|1.368|||GEE model|GEE model with treatment as factor.||||1.368|0.552|0.544
73936099|NCT03198000|147402103|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.893|TWO_SIDED|95.0|-0.085|0.074|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.074|-0.085|0.893
73936100|NCT03198000|147402103|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.886|TWO_SIDED|95.0|-0.073|0.084|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.084|-0.073|0.886
73936101|NCT03198000|147402104|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.117|TWO_SIDED|95.0|-0.177|0.02|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.020|-0.177|0.117
73936102|NCT03198000|147402104|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.049||0.255|TWO_SIDED|95.0|-0.153|0.041|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.041|-0.153|0.255
73936103|NCT03198000|147402106|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.085|TWO_SIDED|95.0|-0.05|0.78|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.78|-0.05|0.085
73936104|NCT03198000|147402106|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.269|TWO_SIDED|95.0|-0.18|0.64|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.64|-0.18|0.269
73936105|NCT03198000|147402107|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.162|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.10|-0.60|0.162
73936106|NCT03198000|147402107|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.234|TWO_SIDED|95.0|-0.55|0.14|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.14|-0.55|0.234
73936107|NCT03198000|147402108|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.398|TWO_SIDED|95.0|-0.48|0.19|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.19|-0.48|0.398
73972925|NCT05265065|147488013|SUPERIORITY||Geometric Mean Ratio|0.71||||0.014|TWO_SIDED|95.0|0.54|0.93|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||0.93|0.54|0.014
73972926|NCT01447719|147488025|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|92.0|||||TWO_SIDED|95.0|78.0|98.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a positive scan based on majority of 5 blinded readers||98|78|
73936108|NCT03198000|147402108|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.233|TWO_SIDED|95.0|-0.54|0.13|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.13|-0.54|0.233
73936109|NCT00366626|147402135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_DEVIATION|6.32||0.51|TWO_SIDED|95.0|-1.85|3.69|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by two medication (naltrexone vs placebo) design. The main hypothesis was that the effect of naltrexone (mean naltrexone drinking - placebo drinking) would be greater in the 40asp subjects than in the asn40asn subjects. Thus the null hypothesis there would be no gene by medication interaction. The mean difference above is then the difference in the size of the naltrexone effect in the two genotypes, equivalent to the interaction.||3.69|-1.85|0.51
73936110|NCT00366626|147402136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|STANDARD_DEVIATION|6.1||0.28|TWO_SIDED|95.0|-1.22|4.11|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by 2 medication (naltrexone vs. placebo)interaction analysis. The main hypothesis was that subjects who had 40asp OPRM1 allele would a greater naltrexone effect on drinking (Placebo - Naltrexxone) than the asn40asn subjects. Thus the null hypothesis was the gene by medication interaction.||4.11|-1.22|0.28
73936111|NCT02255175|147402137|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|t=.501, df=33||||||.620
73936112|NCT02255175|147402138|SUPERIORITY|||||||0.855|||||||t-test, 2 sided|t=.185, df=33||||||.855
73936113|NCT02255175|147402139|SUPERIORITY|||||||0.758|||||||t-test, 2 sided|t=-.310, df=33||||||.758
73936114|NCT02255175|147402140|SUPERIORITY|||||||0.518|||||||t-test, 2 sided|t=.653, df=33||||||.518
73936115|NCT02255175|147402141|SUPERIORITY|||||||0.645|||||||t-test, 2 sided|t=.465, df=33||||||.645
73936116|NCT02255175|147402142|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|t=2.56, df=33||||||.015
73936117|NCT02255175|147402143|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|t=.705, df=33||||||.486
73936118|NCT02255175|147402144|SUPERIORITY|||||||0.831|||||||t-test, 2 sided|t=.216, df=33||||||.831
73936119|NCT02255175|147402145|SUPERIORITY|||||||0.0002|||||||Repeated measures ANOVA|F(1,33)=17.91||||||.0002
73936120|NCT03965052|147402164|OTHER|||||||1|||||||Fisher Exact|||||||1.000
73936121|NCT03965052|147402166|OTHER|||||||1|||||||Fisher Exact|||Lissamine green treatment groups||||1.000
73936122|NCT03965052|147402166|OTHER|||||||0.667|||||||Fisher Exact|||Fluorescein treatment groups||||0.667
73936123|NCT03965052|147402167|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
73936124|NCT03965052|147402168|OTHER|||||||0.977|||||||Chi-squared, Corrected|||the analysis was per protocol||||0.977
73936125|NCT03965052|147402170|OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||0.019
73936126|NCT00358735|147402183|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73936127|NCT00358735|147402184|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73936128|NCT00358735|147402185|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||||||0.0004
73936129|NCT00358735|147402187|SUPERIORITY_OR_OTHER|||||||0.953|||||||Chi-squared|||||||0.953
73936130|NCT00358735|147402188|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.050
73936131|NCT00358735|147402189|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
73936132|NCT00358735|147402190|SUPERIORITY_OR_OTHER|||||||0.507|||||||Chi-squared|||||||0.507
73936133|NCT00358735|147402191|SUPERIORITY_OR_OTHER|||||||0.052|||||||Chi-squared|||||||0.052
73936134|NCT00358735|147402192|SUPERIORITY_OR_OTHER|||||||0.798|||||||Chi-squared|||||||0.798
73936135|NCT00358735|147402193|SUPERIORITY_OR_OTHER|||||||0.036|||||||Chi-squared|||||||0.036
73972927|NCT01447719|147488026|SUPERIORITY_OR_OTHER_LEGACY||Specificity|100.0|||||TWO_SIDED|95.0|80.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 5 blinded readers||100|80|
73936136|NCT04401579|147402236|SUPERIORITY||Cox Proportional Hazard|1.15||||0.047|TWO_SIDED|95.0|1.0|1.31|||Log Rank|||||1.31|1.00|0.047
73936137|NCT04401579|147402252|SUPERIORITY||Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-12.0|0.0||||||||0|-12|
73936138|NCT04401579|147402253|SUPERIORITY||Risk Difference (RD)|-5.0|||||TWO_SIDED|95.0|-10.0|0.0||||||||0|-10|
73936139|NCT04401579|147402263|SUPERIORITY||Odds Ratio (OR)|1.26||||0.44|TWO_SIDED|95.0|1.01|1.57|||Regression, Logistic|||||1.57|1.01|0.44
73936140|NCT04401579|147402273|SUPERIORITY||Cox Proportional Hazard|1.21||||0.002|TWO_SIDED|95.0|1.06|1.39|||Log Rank|||||1.39|1.06|0.002
73936141|NCT04401579|147402274|SUPERIORITY||Cox Proportional Hazard|1.2||||0.005|TWO_SIDED|95.0|1.05|1.38|||Log Rank|||||1.38|1.05|0.005
73936142|NCT04401579|147402275|SUPERIORITY||Cox Proportional Hazard|1.24||||0.003|TWO_SIDED|95.0|1.07|1.44|||Log Rank|||||1.44|1.07|0.003
73936143|NCT04401579|147402278|SUPERIORITY||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.73|1.68||||||This analysis is for Asian participants.||1.68|0.73|
73936144|NCT04401579|147402278|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.75|1.5||||||This analysis is for Black or African American participants.||1.50|0.75|
73936145|NCT04401579|147402278|SUPERIORITY||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.93|1.37||||||This analysis is for White participants.||1.37|0.93|
73936146|NCT04401579|147402278|SUPERIORITY||Cox Proportional Hazard|1.34|||||TWO_SIDED|95.0|1.03|1.74||||||This analysis is for Race of Other participants.||1.74|1.03|
73936147|NCT04401579|147402279|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.08|1.6||||||This analysis is for Not Hispanic or Latino participants||1.60|1.08|
73936148|NCT04401579|147402279|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.89|1.31||||||This analysis is for Hispanic or Latino participants.||1.31|0.89|
73936149|NCT04401579|147402280|SUPERIORITY||Cox Proportional Hazard|1.23|||||TWO_SIDED|95.0|1.04|1.46||||||This analysis is for Male participants.||1.46|1.04|
73936150|NCT04401579|147402280|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||This analysis is for Female participants.||1.32|0.85|
73866199|NCT00767806|147278639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.012|TWO_SIDED|95.0|-0.9|-0.11||P-value is for BPI interference with normal work - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with normal work score during 12 weeks of treatment.||-0.11|-0.90|0.012
73866200|NCT00767806|147278639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.001|TWO_SIDED|95.0|-0.92|-0.22||P-value is for BPI interference with relations to others - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with relations to others score during 12 weeks of treatment.||-0.22|-0.92|0.001
73866201|NCT00767806|147278639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.002|TWO_SIDED|95.0|-1.13|-0.27||P-value is for BPI interference with sleep score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with sleep score during 12 weeks of treatment.||-0.27|-1.13|0.002
73866202|NCT00767806|147278639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.005|TWO_SIDED|95.0|-0.96|-0.18||P-value is for BPI interference with enjoyment of life score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with enjoyment of life score during 12 weeks of treatment.||-0.18|-0.96|0.005
73866203|NCT00767806|147278639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.92|-0.25||P-value is for BPI average interference score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory average interference score during 12 weeks of treatment.||-0.25|-0.92|<0.001
73866204|NCT00767806|147278640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.05|-0.35||p-value is for weekly 24-hour average pain rating score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour average pain rating score during 12 weeks of treatment.||-0.35|-1.05|<0.001
73866205|NCT00767806|147278640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.08|-0.33||p-value is for weekly 24-hour worst pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour worst pain score during 12 weeks of treatment.||-0.33|-1.08|<0.001
73866206|NCT00767806|147278640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.004|TWO_SIDED|95.0|-0.87|-0.17||p-value is for weekly 24-hour night pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour night pain score during 12 weeks of treatment.||-0.17|-0.87|0.004
73936151|NCT03521635|147402281|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|1.68||0.688|TWO_SIDED|95.0|-2.7|4.0|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release|Mean changes from baseline of PDSS-2 score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||4.0|-2.7|0.688
73936152|NCT03521635|147402282|OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.69|TWO_SIDED|95.0|-1.2|0.8|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of NHQ score by patients were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.8|-1.2|0.690
73936153|NCT03521635|147402282|OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.91||0.376|TWO_SIDED|95.0|-2.7|1.1|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of NHQ score by caregivers were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.1|-2.7|0.376
73972928|NCT01447719|147488027|SUPERIORITY_OR_OTHER_LEGACY||Correlation coefficient|0.76|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|95.0|0.62|0.85||A one-sided test (rho \> 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|Asymptotic standard error and 95 percent CI used Fisher z-transformation.||Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.||0.85|0.62|<0.0001
73972929|NCT01447719|147488028|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|96.0|||||TWO_SIDED|95.0|80.0|100.0||||||Proportion of subjects who had a positive scan based on majority of 5 blinded readers||100|80|
73972930|NCT01447719|147488029|SUPERIORITY_OR_OTHER_LEGACY||Specificity|100.0|||||TWO_SIDED|95.0|78.0|100.0||||||Proportion of subjects who had a negative scan based on majority of 5 blinded readers||100|78|
73972931|NCT02518048|147488088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.17|||<|0.001|TWO_SIDED|95.0|-2.58|-1.76||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group).|ANOVA|||A last observation carried forward (LOCF) approach was used to account for drop-outs and missing values in the analysis of end of treatment values.||-1.76|-2.58|<0.001
73936154|NCT03521635|147402283|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.66||0.333|TWO_SIDED|95.0|-1.9|0.7|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep night-time sleep score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.7|-1.9|0.333
73936155|NCT03521635|147402283|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.374|TWO_SIDED|95.0|-0.8|0.3|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep overall night sleep score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.3|-0.8|0.374
73936156|NCT03521635|147402283|OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.49||0.352|TWO_SIDED|95.0|-1.4|0.5|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep daytime sleepiness score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.5|-1.4|0.352
73936157|NCT03521635|147402284|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.259|TWO_SIDED|95.0|-0.8|0.2|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of EMO sore were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.2|-0.8|0.259
73936158|NCT03521635|147402285|OTHER||Odds Ratio (OR)|0.96||||0.9373|TWO_SIDED|95.0|0.36|2.54|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of PDSS-2 score \<18 were performed with treatment and baseline as the independent variables.||2.54|0.36|0.9373
73936159|NCT03521635|147402286|OTHER||Odds Ratio (OR)|2.24||||0.1611|TWO_SIDED|95.0|0.73|7.49|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of EMO score were performed with treatment and baseline as the independent variables.||7.49|0.73|0.1611
74030522|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.103||||0.4759|TWO_SIDED|95.0|0.843|1.442|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.442|0.843|0.4759
73936160|NCT03521635|147402287|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.517|TWO_SIDED|95.0|-2.3|1.2|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of PDQ-8 score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.2|-2.3|0.517
73936161|NCT03521635|147402288|OTHER||Odds Ratio (OR)|3.44||||0.2374|TWO_SIDED|95.0|0.57|36.85|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of CGI-I were performed with treatment as the independent variable.||36.85|0.57|0.2374
73936162|NCT03521635|147402289|OTHER||Odds Ratio (OR)|3.44||||0.2374|TWO_SIDED|95.0|0.57|36.85|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of PGI-I were performed with treatment as the independent variable.||36.85|0.57|0.2374
73936163|NCT03521635|147402290|OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.79||0.82|TWO_SIDED|95.0|-1.4|1.7|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of ESS score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.7|-1.4|0.820
73936164|NCT00071487|147402298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.3677|TWO_SIDED|95.0|-19.4|7.2||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using a last observation carried forward (LOCF) imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||7.2|-19.4|0.3677
73936165|NCT00071487|147402298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.4244|TWO_SIDED|95.0|-8.7|20.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||20.6|-8.7|0.4244
73866207|NCT00767806|147278641|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||p-value is for number of patients who achieve a \>=30% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.||||0.108
73936166|NCT00071487|147402298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.3296|TWO_SIDED|95.0|-19.6|6.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||6.6|-19.6|0.3296
73936167|NCT00071487|147402299|SUPERIORITY_OR_OTHER|||||||0.6423||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.6423
73936168|NCT00071487|147402299|SUPERIORITY_OR_OTHER|||||||0.8536||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.8536
73936169|NCT00071487|147402299|SUPERIORITY_OR_OTHER|||||||0.9705||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.9705
73936170|NCT00071487|147402300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1||||0.1763|TWO_SIDED|95.0|-22.4|4.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||4.1|-22.4|0.1763
73936171|NCT00071487|147402300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.7112|TWO_SIDED|95.0|-20.9|14.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||14.3|-20.9|0.7112
73936172|NCT00071487|147402300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.332|TWO_SIDED|95.0|-22.2|7.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||7.5|-22.2|0.3320
73936173|NCT00071487|147402301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.6||||0.1287|TWO_SIDED|95.0|-65.6|8.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||8.4|-65.6|0.1287
73936174|NCT00071487|147402301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98||||0.8807|TWO_SIDED|95.0|-36.2|42.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||42.1|-36.2|0.8807
73936175|NCT00071487|147402301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.41||||0.1131|TWO_SIDED|95.0|-68.1|7.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||7.3|-68.1|0.1131
73936176|NCT00071487|147402302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.7823|TWO_SIDED|95.0|-13.8|10.4||P-value was not adjusted for multiple testing|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||10.4|-13.8|0.7823
73936177|NCT00071487|147402302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.1774|TWO_SIDED|95.0|-18.2|3.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||3.4|-18.2|0.1774
73936178|NCT00071487|147402302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.6406|TWO_SIDED|95.0|-14.8|9.1|||t-test, 2 sided|P-value was not adjusted for multiple testing.||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||9.1|-14.8|0.6406
73936179|NCT00071487|147402303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.7822|TWO_SIDED|95.0|-38.6|29.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||29.1|-38.6|0.7822
73866208|NCT00767806|147278642|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for number of patients who achieve a \>=50% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=50% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.||||0.006
73936180|NCT00071487|147402303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9||||0.3332|TWO_SIDED|95.0|-45.3|15.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||15.4|-45.3|0.3332
73936181|NCT00071487|147402303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7||||0.466|TWO_SIDED|95.0|-46.9|21.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||21.5|-46.9|0.4660
73972932|NCT02518048|147488091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.53|-0.32||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Total Skin Thickness: LEO 90100 vs. Betesil®||-0.32|-0.53|<0.001
73866209|NCT00767806|147278643|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||p-value is difference between duloxetine and placebo in number of patients who achieve criteria described in null hypothesis|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory (BPI) average pain severity rating from baseline to endpoint and baseline to earlier visit than last visit and maintains a \>=20% reduction of BPI average pain rating from baseline at every visit.||||0.082
73866210|NCT00767806|147278644|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for difference between duloxetine and placebo groups in the empirical overall cumulated distribution of the percentage pain reduction|Kolnogorov-Smirnov test|||Tested was the null hypothesis that there is no difference between duloxetine and placebo groups in the empirical cumulated distribution of the percentage pain reduction.||||0.013
73936182|NCT00071487|147402304|SUPERIORITY_OR_OTHER|||||||0.5615||95.0||||P-value was not adjusted for multiple comparisons.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.5615
73936183|NCT00071487|147402304|SUPERIORITY_OR_OTHER|||||||0.7593||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.7593
73936184|NCT00071487|147402304|SUPERIORITY_OR_OTHER|||||||0.2273||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.2273
73972933|NCT02518048|147488091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.69|-0.41||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Echo-Poor Band Thickness: LEO 90100 vs. Betesil®||-0.41|-0.69|<0.001
73972934|NCT05363163|147488097|OTHER|If the mean volume variation was higher than 0 and the p-value of the statistical test lower than 0.05, the H0 hypothesis was rejected, and the primary endpoint demonstrated.|||||<|0.0001||||||p-value of the statistical test lower than 0.05|t-test, 2 sided|||||||<0.0001
73866211|NCT00767806|147278645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.077|TWO_SIDED|95.0|-0.33|0.02||p-value is for difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score after 12 weeks of treatment.||0.02|-0.33|0.077
73866212|NCT00767806|147278646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.011|TWO_SIDED|95.0|-0.56|-0.07||p-value is for difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value|ANCOVA|Main Effect Model: PGI-I=Treatment+Investigator+Baseline(Type III sums of squares). PGI-Severity score from baseline visit was used as the baseline.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value during 12 weeks of treatment.||-0.07|-0.56|0.011
73936185|NCT00071487|147402305|SUPERIORITY_OR_OTHER||percent difference from placebo|-7.1||||0.4355|TWO_SIDED|95.0|-24.7|10.6||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||10.6|-24.7|0.4355
73972935|NCT03154190|147488104|SUPERIORITY||Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.2|0.47|||Regression, Cox|||||0.47|0.20|
73866213|NCT00767806|147278647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.255|TWO_SIDED|95.0|-1.28|0.34||p-value is for difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score during 12 weeks of treatment.||0.34|-1.28|0.255
73866214|NCT00767806|147278648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.38|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore during 12 weeks of treatment.||-0.37|-1.38|<0.001
73866215|NCT00767806|147278648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.133|TWO_SIDED|95.0|-0.9|0.12||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore during 12 weeks of treatment.||0.12|-0.90|0.133
73936186|NCT00071487|147402305|SUPERIORITY_OR_OTHER||percent difference from placebo|4.4||||0.6669|TWO_SIDED|95.0|-15.5|24.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||24.2|-15.5|0.6669
73936187|NCT00071487|147402305|SUPERIORITY_OR_OTHER||percent difference from placebo|17.7||||0.0882|TWO_SIDED|95.0|-2.5|37.9||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||37.9|-2.5|0.0882
73972936|NCT03154190|147488105|SUPERIORITY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.3|0.75|||Regression, Cox|||||0.75|0.30|
73972937|NCT03154190|147488108|SUPERIORITY||Risk Ratio (RR)|0.45|||||TWO_SIDED|95.0|0.33|0.62||||||||0.62|0.33|
73972938|NCT03154190|147488110|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.36|0.7||||||||0.70|0.36|
73972939|NCT03154190|147488115|SUPERIORITY||Odds Ratio (OR)|4.46|||||TWO_SIDED|95.0|1.88|10.55||||||||10.55|1.88|
73972940|NCT00670241|147488118|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|2.05|5.7|||Cochran-Mantel-Haenszel|||||5.70|2.05|< 0.001
73972941|NCT00670241|147488119|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.51|||<|0.001|TWO_SIDED|98.33|1.46|8.4|||Cochran-Mantel-Haenszel|||||8.40|1.46|<0.001
73936188|NCT01227889|147402307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.26|0.6||The p value from a stratified log-rank test was adjusted for disease stage at screening.|Log Rank||HRs were estimated using a Pike estimator. HR from a stratified log-rank test was adjusted for disease stage at screening.|||0.60|0.26|<0.0001
73936189|NCT01227889|147402308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.2|0.61|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.|||0.61|0.20|
73936190|NCT01227889|147402309|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.57|1.18|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.|||1.18|0.57|
73936191|NCT01169467|147402366|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||t-test, 2 sided|||||||0.395
73936192|NCT04827212|147402370|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.037|TWO_SIDED|||||P\<0.05|Mixed Models Analysis|||||||0.037
73936193|NCT04827212|147402371|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.78|TWO_SIDED|||||p-value is adjusted for multiple comparisons- P\<0.025; controlled for baseline values as there was a significant difference between groups at baseline|Mixed Models Analysis|||||||0.78
73936194|NCT04827212|147402372|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.56|TWO_SIDED|||||adjusted for multiple comparisons- P\<0.025; controlled for baseline value due to a significant difference between groups at baseline|Mixed Models Analysis|||||||0.56
73936195|NCT04827212|147402373|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.4
73936196|NCT04827212|147402374|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.18|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.18
73936197|NCT04827212|147402375|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.86|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.86
73936198|NCT04827212|147402376|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.21|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.21
73936199|NCT04827212|147402377|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.19|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.19
73936200|NCT04827212|147402378|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.12|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.12
73936201|NCT04827212|147402379|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.41|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.41
73936202|NCT04827212|147402380|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.43|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.43
73936203|NCT04827212|147402381|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.53|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.53
73936204|NCT04827212|147402382|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.98|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.98
73936205|NCT04827212|147402383|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.96|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.96
73936206|NCT04827212|147402384|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.91|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.91
73936207|NCT04827212|147402385|SUPERIORITY||Mean Difference (Final Values)|13.1||||0.25|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.25
73936208|NCT04827212|147402386|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.46|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.46
73936209|NCT04827212|147402387|SUPERIORITY||Mean Difference (Final Values)|9.6||||0.41|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.41
73936210|NCT04827212|147402388|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.12|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.12
73936211|NCT04827212|147402389|SUPERIORITY||Mean Difference (Final Values)|-11.9||||0.2|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.20
73972942|NCT00670241|147488120|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.7|||<|0.001|TWO_SIDED|98.33|-22.6|-6.9|||ANOVA|||||-6.90|-22.6|<0.001
73972943|NCT05683340|147488126|SUPERIORITY||Least squares mean difference|-21.78|STANDARD_ERROR_OF_MEAN|2.482||0.001|TWO_SIDED|95.0|-26.71|-16.85|||MMRM||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-16.85|-26.71|0.001
73936212|NCT04827212|147402390|SUPERIORITY||Mean Difference (Final Values)|-14.0||||0.13|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.13
73936213|NCT04827212|147402391|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.94|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.94
73936214|NCT04827212|147402392|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.72|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.72
73936215|NCT04827212|147402393|SUPERIORITY||Mean Difference (Final Values)|12.3||||0.33|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.33
73936216|NCT03108924|147402395|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.53|1.13||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.13|0.53|
73936217|NCT03108924|147402398|OTHER||GMR|2.98|||||TWO_SIDED|90.0|2.01|4.41||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||4.41|2.01|
73936218|NCT03108924|147402398|OTHER||GMR|4.43|||||TWO_SIDED|95.0|2.82|6.96||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||6.96|2.82|
73866216|NCT00767806|147278648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|||<|0.001|TWO_SIDED|95.0|-1.46|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score during 12 weeks of treatment.||-0.37|-1.46|<0.001
73866217|NCT00767806|147278648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13||||0.003|TWO_SIDED|95.0|0.38|1.88||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score during 12 weeks of treatment.||1.88|0.38|0.003
73866218|NCT00767806|147278648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.469|TWO_SIDED|95.0|-0.93|0.43||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score during 12 weeks of treatment.||0.43|-0.93|0.469
73866219|NCT00767806|147278648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.006|TWO_SIDED|95.0|-0.98|-0.17||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score during 12 weeks of treatment.||-0.17|-0.98|0.006
73866220|NCT00767806|147278648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.001|TWO_SIDED|95.0|-6.41|-1.6||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score during 12 weeks of treatment.||-1.60|-6.41|0.001
73866221|NCT00767806|147278649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.168|TWO_SIDED|95.0|-0.53|3.02||p-value is for difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score during 12 weeks of treatment.||3.02|-0.53|0.168
73936219|NCT03108924|147402398|OTHER||GMR|4.74|||||TWO_SIDED|90.0|2.95|7.59||||Categorical Analysis|GMR = GM for ESRD HD / GM for Healthy Controls|||7.59|2.95|
74088864|NCT00680186|147730896|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.6932||95.0|-1.1|1.6|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.6|-1.1|0.6932
74088865|NCT00680186|147730896|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.6383||95.0|0.75|1.6|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.60|0.75|0.6383
73866222|NCT00767806|147278649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.01|TWO_SIDED|95.0|0.53|3.96||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score during 12 weeks of treatment.||3.96|0.53|0.010
73866223|NCT00767806|147278649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.58||||0.016|TWO_SIDED|95.0|0.86|8.3||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score during 12 weeks of treatment.||8.30|0.86|0.016
73866224|NCT00767806|147278649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.88|||<|0.001|TWO_SIDED|95.0|2.15|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score during 12 weeks of treatment.||7.61|2.15|<0.001
73936220|NCT03108924|147402400|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.54|1.08||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.08|0.54|
73936221|NCT03108924|147402403|OTHER||GMR|3.23|||||TWO_SIDED|90.0|2.01|5.2||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||5.20|2.01|
73936222|NCT03108924|147402403|OTHER||GMR|4.08|||||TWO_SIDED|90.0|2.49|6.7||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||6.70|2.49|
73936223|NCT03108924|147402403|OTHER||GMR|4.43|||||TWO_SIDED|90.0|2.65|7.39||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||7.39|2.65|
73936224|NCT03108924|147402405|OTHER||GMR|0.73|||||TWO_SIDED|90.0|0.52|1.03||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.03|0.52|
73972944|NCT02056834|147488143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.||||0.0166
73866225|NCT00767806|147278649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.58||||0.101|TWO_SIDED|95.0|-0.5|5.67||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score during 12 weeks of treatment.||5.67|-0.50|0.101
73866226|NCT00767806|147278649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.058|TWO_SIDED|95.0|-0.12|7.12||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score during 12 weeks of treatment.||7.12|-0.12|0.058
73866227|NCT00767806|147278649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43||||0.227|TWO_SIDED|95.0|-1.52|6.37||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score during 12 weeks of treatment.||6.37|-1.52|0.227
73936225|NCT03108924|147402408|OTHER||GMR|2.09|||||TWO_SIDED|90.0|1.22|3.56||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||3.56|1.22|
73936226|NCT03108924|147402408|OTHER||GMR|1.89|||||TWO_SIDED|95.0|1.1|3.25||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||3.25|1.10|
73936227|NCT03108924|147402408|OTHER||GMR|1.9|||||TWO_SIDED|90.0|1.13|3.19||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||3.19|1.13|
73936228|NCT03108924|147402410|OTHER||GMR|1.3|||||TWO_SIDED|90.0|0.88|1.9||||Categorical Analysis|GMR = GM for ESRD / GM for ESRD Non-HD|||1.90|0.88|
73936229|NCT03108924|147402413|OTHER||GMR|0.34|||||TWO_SIDED|95.0|0.23|0.5||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||0.50|0.23|
73936230|NCT03108924|147402413|OTHER||GMR|0.23|||||TWO_SIDED|95.0|0.14|0.35||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||0.35|0.14|
73936231|NCT03108924|147402413|OTHER||GMR|0.21|||||TWO_SIDED|95.0|0.13|0.34||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||0.34|0.13|
73936232|NCT03108924|147402415|OTHER||GMR|0.31|||||TWO_SIDED|90.0|0.25|0.39||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||0.39|0.25|
73936233|NCT03108924|147402415|OTHER||GMR|0.1|||||TWO_SIDED|90.0|0.07|0.16||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||0.16|0.07|
73936234|NCT00148343|147402432|SUPERIORITY_OR_OTHER||Slope|1.26|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-0.2|2.75|||||Mixed model analysis. Slope is in reference to treatment x time interaction for full 36 weeks|||2.75|-0.2|
73936235|NCT00148343|147402433|SUPERIORITY||Slope|-5.07|STANDARD_ERROR_OF_MEAN|2.54|<|0.05|TWO_SIDED|95.0|-10.05|-0.09|||Mixed Models Analysis||Slope is in reference to from baseline to end of follow-up at 36 weeks.|||-0.09|-10.05|<0.05
73936236|NCT00148343|147402434|SUPERIORITY_OR_OTHER||Slope|0.31|STANDARD_ERROR_OF_MEAN|7.35|<|0.05|TWO_SIDED|95.0|-14.096|14.716|||Mixed Models Analysis||Slope is in reference to start of treatment to end of follow up at 36 weeks|||14.716|-14.096|<0.05
73936237|NCT00148343|147402435|SUPERIORITY||Slope|-1.95|STANDARD_ERROR_OF_MEAN|5.53|||TWO_SIDED|95.0|-12.79|8.89|||||Mixed models analysis. Slope refers to baseline to final follow up at 36 weeks|||8.89|-12.79|
73972945|NCT02056834|147488144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.||||0.3785
73936238|NCT00148343|147402436|SUPERIORITY||Slope|0.006|STANDARD_ERROR_OF_MEAN|0.026|<|0.05|TWO_SIDED|95.0|-0.045|0.057|||Mixed Models Analysis||Slope is in reference to baseline to end of follow-up at 36 weeks|||0.057|-0.045|<0.05
73936239|NCT03579459|147402437|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|Geometric Mean ratio (GMR)|1.01|||||TWO_SIDED|95.0|0.86|1.18|||||Confidence intervals (CIs) were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.18|0.86|
73936240|NCT03579459|147402437|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.01|||||TWO_SIDED|95.0|0.86|1.18|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.18|0.86|
73936241|NCT03579459|147402437|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.0|||||TWO_SIDED|95.0|0.85|1.17|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.17|0.85|
73936242|NCT03579459|147402437|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.07|||||TWO_SIDED|95.0|0.87|1.31|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.31|0.87|
73936243|NCT03579459|147402437|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.07|||||TWO_SIDED|95.0|0.88|1.31|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.31|0.88|
73936244|NCT03579459|147402437|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.01|||||TWO_SIDED|95.0|0.83|1.23|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.23|0.83|
73972946|NCT02056834|147488145|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.||||<0.0001
73972947|NCT02056834|147488146|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.||||<0.0001
73866228|NCT00767806|147278649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91||||0.383|TWO_SIDED|95.0|-2.39|6.21||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score during 12 weeks of treatment.||6.21|-2.39|0.383
73866229|NCT00767806|147278649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.03|TWO_SIDED|95.0|0.38|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score during 12 weeks of treatment.||7.61|0.38|0.030
73866230|NCT00767806|147278649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.022|TWO_SIDED|95.0|0.59|7.6||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score during 12 weeks of treatment.||7.60|0.59|0.022
73866231|NCT00767806|147278650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||<|0.001|TWO_SIDED|95.0|0.03|0.12||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score during 12 weeks of treatment.||0.12|0.03|<0.001
73866232|NCT00767806|147278650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.002|TWO_SIDED|95.0|0.02|0.08||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score during 12 weeks of treatment.||0.08|0.02|0.002
73866233|NCT00767806|147278651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.461|TWO_SIDED|95.0|-0.03|0.06||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score during 12 weeks of treatment.||0.06|-0.03|0.461
73936245|NCT04153409|147402446|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Statistical comparisons of the 7 mean changes from baseline to different time-points (0-24 hours) were undertaken in one mixed effects model of analysis taking into account the cross-over nature of the study and the multiple time points within each period to explore a possible treatment effect in this small proof of concept study. Change from baseline at 0.5 hours is presented in this section|Mean Difference (Net)|-0.02||||0.9733|TWO_SIDED|95.0|-1.23|1.19||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 0.5 hours||1.19|-1.23|0.9733
73936246|NCT04153409|147402446|SUPERIORITY||Mean Difference (Net)|-0.42||||0.4942|TWO_SIDED|95.0|-1.64|0.79||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 1 hour. The change from baseline at 1 hour was extracted from the mixed model analysis including all time points.||0.79|-1.64|0.4942
73936247|NCT04153409|147402446|SUPERIORITY||Mean Difference (Net)|-0.25||||0.6866|TWO_SIDED|95.0|-1.46|0.97||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 1.5 hours. The change from baseline at 1.5 hours was extracted from the mixed model analysis including all time points.||0.97|-1.46|0.6866
73972948|NCT02990338|147488274|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.596||||0.0005|TWO_SIDED|95.0|0.436|0.814||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025.|Log Rank|Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.|Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.|Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.||0.814|0.436|0.0005
73972949|NCT02990338|147488275|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|||||<|0.0001||||||Threshold for statistical significance at 0.025.|Cochran-Mantel-Haenszel|One sided p-value was stratified based on age (\<75 years versus \>=75 years) and number of previous lines (2 or 3 versus \>3) according to IRT.||||||<0.0001
73866234|NCT00767806|147278651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.374|TWO_SIDED|95.0|-0.09|0.03||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score during 12 weeks of treatment.||0.03|-0.09|0.374
73866235|NCT00767806|147278651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.557|TWO_SIDED|95.0|-0.09|0.05||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score during 12 weeks of treatment.||0.05|-0.09|0.557
73936248|NCT04153409|147402446|SUPERIORITY||Mean Difference (Net)|-0.89||||0.1488|TWO_SIDED|95.0|-2.11|0.32||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 2 hours. The change from baseline at 2 hours was extracted from the mixed model analysis including all time points.||0.32|-2.11|0.1488
73936249|NCT04153409|147402446|SUPERIORITY||Mean Difference (Net)|-0.36||||0.5644|TWO_SIDED|95.0|-1.57|0.86||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 4 hours. The change from baseline at 4 hours was extracted from the mixed model analysis including all time points.||0.86|-1.57|0.5644
73972950|NCT02990338|147488279|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.776||||0.0319|TWO_SIDED|95.0|0.594|1.015||One-sided significance level was 0.02 using the O'Brien-Fleming alpha spending function.|Log Rank|Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.|Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.|||1.015|0.594|0.0319
73866236|NCT00767806|147278651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.007|TWO_SIDED|95.0|-0.1|-0.02||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score during 12 weeks of treatment.||-0.02|-0.10|0.007
73866237|NCT00767806|147278653|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for difference between placebo and duloxetine groups in uric acid - change|ANOVA|Change Variable = Treatment + Investigator (Type III sums of squares). Rank-transformed change was used as change variable in the ANOVA model.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of uric acid during 12 weeks of treatment.||||0.010
73866238|NCT00767806|147278654|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||p-value is for difference between duloxetine and placebo in albumin - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Albumin during 12 weeks of treatment.||||0.031
73866239|NCT00767806|147278655|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for difference between duloxetine and placebo in alkaline phosphatase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of alkaline phosphatase during 12 weeks of treatment.||||0.004
73866240|NCT00767806|147278656|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for difference between duloxetine and placebo in alanine aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Alanine Aminotransferase during 12 weeks of treatment.||||0.013
73972951|NCT00971087|147488298|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|3D + s2D will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. That is, our null hypothesis is that the AUC for 3D + s2D is 0.05 less than the AUC for 2D FFDM. A difference of 0.05 is considered a clinically significant difference.||||||0.009|||||||MRMC ROC Analysis|||A multi-reader, multi-case ROC analysis will be used to compare 3D + s2D to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance.||||0.009
73972952|NCT00971087|147488299|NON_INFERIORITY|A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit onesided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05.||||||0.045|||||||MRMC ROC Analysis|||||||0.045
74088866|NCT00680186|147730897|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.6||||0.1703||95.0|-0.3|1.5|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.5|-0.3|0.1703
73866241|NCT00767806|147278657|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||p-value for difference between duloxetine and placebo in aspartate aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of aspartate aminotransferase during 12 weeks of treatment.||||0.039
73866242|NCT00767806|147278658|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value is for difference between duloxetine and placebo in creatinine - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of creatinine during 12 weeks of treatment.||||0.024
73866243|NCT00767806|147278659|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for difference between duloxetine and placebo in total protein - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of total protein during 12 weeks of treatment.||||0.019
73866244|NCT00767806|147278660|SUPERIORITY_OR_OTHER|||||||0.329||95.0||||p-value is for difference between placebo and duloxetine groups in change of systolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of systolic blood pressure during 12 weeks of treatment.||||0.329
73866245|NCT00767806|147278660|SUPERIORITY_OR_OTHER|||||||0.562||95.0||||p-value is for difference between placebo and duloxetine groups in change of diastolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of diastolic blood pressure during 12 weeks of treatment.||||0.562
73866246|NCT00767806|147278662|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||p-value is for difference between duloxetine and placebo in pulse rate - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of pulse rate during 12 weeks of treatment.||||0.680
73866247|NCT01272635|147278664|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.04|TWO_SIDED|95.0|0.41|0.98|||Discrete time survival analysis||Hazard ratio: Numerator is Azithromycin and Denominator is Placebo|||0.98|0.41|0.04
73866248|NCT02397057|147278673|OTHER|Observed cases, logistic regression analysis. Subjects with missing data on Day 42 were excluded from the statistical testing.|Odds Ratio (OR)|1.35||||0.369|TWO_SIDED|95.0|0.7|2.63||p-value was estimated by logistic regression with treatment, region (US, EUR), and baseline RLS medication-related augmentation as fixed factors, and baseline IRLS as a covariate.|Regression, Logistic|||||2.63|0.70|0.3690
73866249|NCT02397057|147278677|OTHER||Least square(LS) mean difference|-4.071|STANDARD_ERROR_OF_MEAN|2.542||0.1108|TWO_SIDED|95.0|-9.083|0.941|||ANCOVA|||LOCF, ANCOVA Analysis||0.941|-9.083|0.1108
73866250|NCT02397057|147278678|OTHER|||||||0.0002||||||p-value was estimated using continuity-corrected chi-square test.|Chi-squared, Corrected|||||||0.0002
73866251|NCT01393639|147278679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|||||TWO_SIDED|60.0|5.0|15.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||15|5|
73866252|NCT01393639|147278679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.0|||||TWO_SIDED|60.0|18.0|31.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||31|18|
73866253|NCT01393639|147278679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.0|||||TWO_SIDED|60.0|25.0|39.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||39|25|
73936250|NCT04153409|147402446|SUPERIORITY||Mean Difference (Net)|-0.7||||0.2561|TWO_SIDED|95.0|-1.91|0.51||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 8 hours, The change from baseline at 8 hours was extracted from the mixed model analysis including all time points.||0.51|-1.91|0.2561
73936251|NCT04153409|147402446|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9875|TWO_SIDED|95.0|-1.22|1.2||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 24 hours. The change from baseline at 24 hours was extracted from the mixed model analysis including all time points.||1.20|-1.22|0.9875
73972953|NCT04479761|147488301|OTHER|T test derived from a linear mixed effects model|Mean Difference (Final Values)|0.52||||0.005|TWO_SIDED|95.0|||||Mixed Models Analysis||we provided the mean difference between the vestibular group and healthy controls for the reported condition.|||||0.005
73866254|NCT01393639|147278679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|36.0|||||TWO_SIDED|60.0|29.0|43.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||43|29|
73936252|NCT01592435|147402456|SUPERIORITY_OR_OTHER|||||||0.02||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided|||||||0.02
73866255|NCT01393639|147278679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0|||||TWO_SIDED|60.0|6.0|22.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||22|6|
73866256|NCT01393639|147278679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.0|||||TWO_SIDED|60.0|27.0|42.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||42|27|
73866257|NCT01393639|147278679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.0|||||TWO_SIDED|60.0|-32.0|-17.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||-17|-32|
73866258|NCT01393639|147278679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|||||TWO_SIDED|60.0|-16.0|-4.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||-4|-16|
73866259|NCT01393639|147278679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|60.0|-9.0|4.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||4|-9|
73936253|NCT01592435|147402457|SUPERIORITY_OR_OTHER|||||||0||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided|||||||0.00
73866260|NCT01393639|147278679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|||||TWO_SIDED|60.0|-5.0|8.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||8|-5|
73866261|NCT01393639|147278680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.64|||||TWO_SIDED|95.0|-13.75|17.03|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||17.03|-13.75|
73866262|NCT01393639|147278680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.71|||||TWO_SIDED|90.0|-22.16|8.75|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||8.75|-22.16|
73972954|NCT04479761|147488302|OTHER|T tests derived from linear mixed effects model|Mean Difference (Final Values)|0.23||||0.008|TWO_SIDED||||||Mixed Models Analysis||we provided the mean difference between the vestibular group and the controls on the reported condition.|||||0.008
74008332|NCT03627767|147566502|SUPERIORITY||LSM difference|-2.7|||=|0.0012|TWO_SIDED|95.0|-4.3|-1.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.1|-4.3|= 0.0012
74030523|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.656||||0.018|TWO_SIDED|95.0|0.462|0.93|||Regression, Logistic|||The statistical analysis is presented for Alanine transaminase (ALT) ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.930|0.462|0.0180
74030524|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.742||||0.0262|TWO_SIDED|95.0|0.57|0.965|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.965|0.570|0.0262
74030525|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.717||||0.0069|TWO_SIDED|95.0|0.563|0.913|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.913|0.563|0.0069
74030526|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.062|||<|0.0001|TWO_SIDED|95.0|1.056|1.067|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.067|1.056|<0.0001
74030527|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.107||||0.0062|TWO_SIDED|95.0|1.029|1.191|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.191|1.029|0.0062
74030528|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.739||||0.0295|TWO_SIDED|95.0|0.563|0.97|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.563|0.0295
74030529|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.166|||<|0.0001|TWO_SIDED|95.0|0.083|0.329|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.329|0.083|<0.0001
74030530|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.049||||0.0048|TWO_SIDED|95.0|1.015|1.084|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.084|1.015|0.0048
74030531|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.797||||0.0019|TWO_SIDED|95.0|2.136|28.458|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||28.458|2.136|0.0019
74030532|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.638||||0.0255|TWO_SIDED|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.946|0.431|0.0255
74030533|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.755||||0.0059|TWO_SIDED|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.922|0.618|0.0059
74030534|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.521||||0.0005|TWO_SIDED|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.236|1.501|0.0005
73866263|NCT01393639|147278680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.07|||||TWO_SIDED|90.0|-20.45|10.3|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||10.30|-20.45|
73866264|NCT01393639|147278680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.74|||||TWO_SIDED|90.0|-27.19|3.72|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||3.72|-27.19|
73866265|NCT01393639|147278681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.34|||||TWO_SIDED|95.0|-12.92|19.61|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||19.61|-12.92|
73866266|NCT01393639|147278681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.52|||||TWO_SIDED|90.0|-22.86|9.81|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||9.81|-22.86|
73866267|NCT01393639|147278681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.22|||||TWO_SIDED|90.0|-12.11|20.55|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||20.55|-12.11|
73866268|NCT01393639|147278681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.83|||||TWO_SIDED|90.0|-3.49|29.15|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||29.15|-3.49|
73866269|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|11.36|||||TWO_SIDED|95.0|-6.84|29.56|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||29.56|-6.84|
73866270|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.15|||||TWO_SIDED|95.0|-5.88|30.19|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||30.19|-5.88|
73866271|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.54|||||TWO_SIDED|95.0|0.91|38.17|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||38.17|0.91|
73866272|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|22.09|||||TWO_SIDED|95.0|3.6|40.58|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||40.58|3.60|
73866273|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.43|||||TWO_SIDED|95.0|-9.38|26.25|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||26.25|-9.38|
73866274|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|16.5|||||TWO_SIDED|95.0|-1.84|34.84|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||34.84|-1.84|
73866275|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.88|||||TWO_SIDED|95.0|-28.58|10.8|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.80|-28.58|
73936254|NCT02528214|147402479|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Least Square (LS) Mean Difference|28.24|||<|0.0001|TWO_SIDED|95.0|15.81|40.67||Threshold for significance at two-sided 0.05 level.|ANCOVA||LS mean difference represents reduction difference i.e. dupilumab - placebo.|The outcome measure was analyzed using analysis of covariance (ANCOVA) model which included percentage reduction of OCS dose at Week 24 as the response variable, and treatment group, baseline eosinophil level, optimized OCS dose at baseline, region as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.||40.67|15.81|< 0.0001
73936255|NCT02528214|147402481|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|3.98|||<|0.0001|TWO_SIDED|95.0|2.06|7.67||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved the 50% OCS dose reduction criterion as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||7.67|2.06|< 0.0001
74030535|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.602||||0.0011|TWO_SIDED|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.627|1.463|0.0011
73866276|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.31|||||TWO_SIDED|95.0|-4.85|35.49|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||35.49|-4.85|
73866277|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|26.66|||||TWO_SIDED|95.0|6.8|46.53|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||46.53|6.80|
73866278|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|13.19|||||TWO_SIDED|95.0|-7.01|33.4|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||33.40|-7.01|
73866279|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-11.56|29.33|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||29.33|-11.56|
73866280|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|25.21|||||TWO_SIDED|95.0|5.35|45.07|||||Non-responder imputation was used to handle dropouts.|Week 4 comparisons presented in this section for comparison to placebo.||45.07|5.35|
74008333|NCT03627767|147566502|SUPERIORITY||LSM difference|-1.9|||||TWO_SIDED|95.0|-3.0|-0.8||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.8|-3.0|
73866281|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-17.4|21.85|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||21.85|-17.40|
73866282|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.6|||||TWO_SIDED|95.0|-4.24|35.45|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||35.45|-4.24|
73866283|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|22.22|||||TWO_SIDED|95.0|2.2|42.23|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||42.23|2.20|
73936256|NCT02528214|147402482|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|4.48|||<|0.0001|TWO_SIDED|95.0|2.39|8.39||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved a reduction of OCS dose to \<5 mg/day at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||8.39|2.39|< 0.0001
73936257|NCT02528214|147402483|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.57||||0.0024|TWO_SIDED|95.0|1.4|4.73||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome was analyzed using a logistic regression model. The model included binary status of whether or not a participant achieved their maximum possible reduction of OCS dose per protocol at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||4.73|1.4|0.0024
73936258|NCT02528214|147402484|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.74||||0.0015|TWO_SIDED|95.0|1.47|5.1||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant no longer required OCS at Week 24 as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.||5.1|1.47|0.0015
73936259|NCT00941603|147402507|SUPERIORITY_OR_OTHER||Difference in percent|-3.5||||0.06|TWO_SIDED|95.0|-7.2|0.2|||ANOVA|Least-square (LS) means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||0.2|-7.2|0.06
73972955|NCT02542631|147488325|NON_INFERIORITY|The sample size determination was based on the primary endpoint, A1C change from Baseline to Week 24. Assuming that the true mean difference in A1C change for Finesse versus Pen was -0.1% with a SD of 1.2%, a study population of 250 completers (125 per arm) was required to achieve a power of 90% for non-inferiority with a margin of 0.4%.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.32|0.14||Non-inferiority p-value was calculated with 2-sided comparison of the difference in treatment effects between Finesse and Pen with a non-inferiority margin of 0.4%.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||0.14|-0.32|<0.0001
73972956|NCT02542631|147488326|SUPERIORITY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.25||0.26|TWO_SIDED|95.0|0.81|2.14||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel|||||2.14|0.81|0.26
73972957|NCT02542631|147488327|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|3.36||0.38|TWO_SIDED|95.0|-9.63|3.7||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ACNOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||3.70|-9.63|0.38
73972958|NCT02542631|147488328|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.99|TWO_SIDED|95.0|-0.28|0.28||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||0.28|-0.28|0.99
74088867|NCT00680186|147730897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||0.1054||95.0|0.9|3.01|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||3.01|0.90|0.1054
74088868|NCT00680186|147730898|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.4||||0.2283||95.0|-1.1|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.3|-1.1|0.2283
74088869|NCT00680186|147730898|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.2101||95.0|0.26|1.35|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.35|0.26|0.2101
73972959|NCT02542631|147488329|SUPERIORITY||Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.28||0.71|TWO_SIDED|95.0|0.64|1.93||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel|||||1.93|0.64|0.71
73972960|NCT02542631|147488330|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.52|TWO_SIDED|95.0|-0.12|0.24||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and week 24 value as a covariate was used to compare devices for continuous measures.||||0.24|-0.12|0.52
73972961|NCT02542631|147488331|SUPERIORITY||Mean Difference (Final Values)|9.16|STANDARD_ERROR_OF_MEAN|2.8||0.001|TWO_SIDED|95.0|3.65|14.67||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.||||14.67|3.65|0.001
73936260|NCT00941603|147402507|SUPERIORITY_OR_OTHER||Difference in percent|-3.1||||0.1|TWO_SIDED|95.0|-6.7|0.6||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|ANOVA|||||0.6|-6.7|0.10
73936261|NCT00941603|147402507|SUPERIORITY_OR_OTHER||Difference in percent|-5.7|||<|0.01|TWO_SIDED|95.0|-9.4|-2.0|||ANOVA|||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||-2.0|-9.4|<0.01
73936262|NCT00941603|147402507|SUPERIORITY_OR_OTHER||Difference in percent|-1.3||||0.48|TWO_SIDED|95.0|-5.0|2.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||2.4|-5.0|0.48
73936263|NCT00941603|147402507|SUPERIORITY_OR_OTHER||Difference in percent|-0.4||||0.85|TWO_SIDED|95.0|-4.0|3.3|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||3.3|-4.0|0.85
73936264|NCT00941603|147402508|SUPERIORITY_OR_OTHER||Difference in percent|-3.0||||0.09|TWO_SIDED|95.0|-6.5|0.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||0.4|-6.5|0.09
73936265|NCT00941603|147402508|SUPERIORITY_OR_OTHER||Difference in percent|-3.6||||0.04|TWO_SIDED|95.0|-7.1|-0.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||-0.2|-7.1|0.04
73936266|NCT00941603|147402508|SUPERIORITY_OR_OTHER||Difference in percent|-4.4||||0.01|TWO_SIDED|95.0|-7.9|-1.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||-1.0|-7.9|0.01
73936267|NCT00941603|147402508|SUPERIORITY_OR_OTHER||Difference in percent|-1.4||||0.41|TWO_SIDED|95.0|-4.9|2.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||2.0|-4.9|0.41
73936268|NCT00941603|147402508|SUPERIORITY_OR_OTHER||Difference in percent|0.7||||0.68|TWO_SIDED|95.0|-2.7|4.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||4.2|-2.7|0.68
73936269|NCT00407537|147402509|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-4.72|||<|0.001|TWO_SIDED|95.0|-5.55|-3.89||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|It was estimated that each study site would on average complete 8 evaluable participants, therefore enrolling 164 sites, 1968 participants would provide at least 90% power to detect a 10% relative reduction in the 10-year predicted risk of total CHD at 12 months (as calculated from the Framingham model) from the control arm based on a two-sided t-test with a 5% significance level.||-3.89|-5.55|<0.001
73936270|NCT00407537|147402510|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-4.76|||<|0.001|TWO_SIDED|95.0|-5.58|-3.93||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-3.93|-5.58|<0.001
73936271|NCT00407537|147402511|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-0.97|||<|0.001|TWO_SIDED|95.0|-1.23|-0.72||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-0.72|-1.23|<0.001
73936272|NCT00407537|147402512|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-0.88|||<|0.001|TWO_SIDED|95.0|-1.16|-0.59||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-0.59|-1.16|<0.001
73936273|NCT00407537|147402513|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.56|-1.15||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-1.15|-1.56|<0.001
73936274|NCT00407537|147402514|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.57|-1.14||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-1.14|-1.57|<0.001
73936275|NCT00407537|147402519|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.15|||<|0.007|TWO_SIDED|95.0|-5.42|-0.88|||Mixed-effect linear model|||||-0.88|-5.42|<0.007
73972962|NCT02542631|147488332|SUPERIORITY||Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|2.03||0.03|TWO_SIDED|95.0|0.33|8.32||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.||||8.32|0.33|0.03
74030536|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.727||||0.0034|TWO_SIDED|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.491|1.198|0.0034
74030537|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.545||||0.0014|TWO_SIDED|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.792|0.376|0.0014
74030538|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.047|||<|0.0001|TWO_SIDED|95.0|1.029|1.065|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.065|1.029|<0.0001
73936276|NCT00407537|147402520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.61|||<|0.011|TWO_SIDED|95.0|-2.86|-0.37|||Mixed-effect linear model|||||-0.37|-2.86|<0.011
73936277|NCT00407537|147402521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.75|||<|0.001|TWO_SIDED|95.0|-8.0|-3.5|||Mixed-effect linear model|||||-3.50|-8.00|<0.001
73936278|NCT00407537|147402522|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.17|||<|0.001|TWO_SIDED|95.0|-4.42|-1.92|||Mixed-effect linear model|||||-1.92|-4.42|<0.001
73936279|NCT00407537|147402523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.94|||<|0.001|TWO_SIDED|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-34.17|-43.71|<0.001
73936280|NCT00407537|147402523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.31|||<|0.001|TWO_SIDED|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-30.99|-39.64|<0.001
73936281|NCT00407537|147402523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.087|TWO_SIDED|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL||2.13|-0.14|0.087
73936282|NCT00407537|147402523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.65|||<|0.001|TWO_SIDED|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effects linear model|||Triglycerides||-14.70|-32.60|<0.001
73936283|NCT00407537|147402524|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.07|||<|0.001|TWO_SIDED|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-28.56|-37.57|<0.001
73936284|NCT00407537|147402524|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.83|||<|0.001|TWO_SIDED|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-25.95|-33.70|<0.001
73972963|NCT02542631|147488333|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
73972964|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|2.19||||0.853|TWO_SIDED|95.0|-21.16|25.54||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.19|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||25.54|-21.16|0.853
73972965|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|5.04||||0.767|TWO_SIDED|95.0|-28.57|38.65||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.30|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||38.65|-28.57|0.767
74030539|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.896||||0.0074|TWO_SIDED|95.0|0.827|0.971|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.971|0.827|0.0074
73936285|NCT00407537|147402524|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58||||0.379|TWO_SIDED|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL||1.86|-0.71|0.379
73936286|NCT00407537|147402524|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.001|TWO_SIDED|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-7.81|-28.72|<0.001
73936287|NCT00407537|147402525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.94|||<|0.001|TWO_SIDED|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-34.17|-43.71|<0.001
73936288|NCT00407537|147402525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.31|||<|0.001|TWO_SIDED|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-30.99|-39.64|<0.001
73936289|NCT00407537|147402525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.087|TWO_SIDED|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL||2.13|-0.14|0.087
73936290|NCT00407537|147402525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.65|||<|0.001|TWO_SIDED|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-14.70|-32.60|<0.001
73936291|NCT00407537|147402526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.07|||<|0.001|TWO_SIDED|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Total cholesterol||-28.56|-37.57|<0.001
73936292|NCT00407537|147402526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.83|||<|0.001|TWO_SIDED|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-25.95|-33.70|<0.001
73936293|NCT00407537|147402526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58||||0.379|TWO_SIDED|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL||1.86|-0.71|0.379
73936294|NCT00407537|147402526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.001|TWO_SIDED|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-7.81|-28.72|<0.001
73936295|NCT02347761|147402542|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mea Difference (SE)|0.1036|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0663|0.1409||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|MMixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of this endpoint|standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1409|0.0663|<0.0001
73936296|NCT02347761|147402542|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mean Difference (SE)|0.0961|STANDARD_ERROR_OF_MEAN|0.01896|<|0.0001|TWO_SIDED|95.0|0.0589|0.1334||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|Mixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of the endpoint.|Standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1334|0.0589|<0.0001
73936297|NCT02347761|147402543|SUPERIORITY||Least Squares Mean (SE)|0.1264|STANDARD_ERROR_OF_MEAN|0.02076|<|0.0001|TWO_SIDED|95.0|0.0856|0.1672||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least squares mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1672|0.0856|<0.0001
73972966|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|2.84||||0.868|TWO_SIDED|95.0|-30.93|36.62||Unadjusted p-value|Mixed Models Analysis|t (df,112) = 0.17|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||36.62|-30.93|0.868
73972967|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.96|TWO_SIDED|95.0|-24.26|25.52||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.05|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||25.52|-24.26|0.960
73972968|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|8.42||||0.63|TWO_SIDED|95.0|-25.97|42.82||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.48|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||42.82|-25.97|0.630
74030540|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.971||||0.0088|TWO_SIDED|95.0|0.95|0.993|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.993|0.950|0.0088
74030541|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.719|||<|0.0001|TWO_SIDED|95.0|0.643|0.803|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.803|0.643|<0.0001
74030542|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.683|||<|0.0001|TWO_SIDED|95.0|1.346|2.106|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.106|1.346|<0.0001
74030543|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.4479|TWO_SIDED|95.0|0.848|1.453|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.453|0.848|0.4479
74030544|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.0123|TWO_SIDED|95.0|0.451|0.908|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.908|0.451|0.0123
74030545|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.0147|TWO_SIDED|95.0|0.553|0.937|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.937|0.553|0.0147
74030546|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.718||||0.0071|TWO_SIDED|95.0|0.564|0.914|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.914|0.564|0.0071
74030547|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.058|||<|0.0001|TWO_SIDED|95.0|1.052|1.064|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.064|1.052|<0.0001
74030548|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||0.0019|TWO_SIDED|95.0|1.005|1.023|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.023|1.005|0.0019
74030549|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.701||||0.0083|TWO_SIDED|95.0|0.539|0.913|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.913|0.539|0.0083
74030550|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.174|||<|0.0001|TWO_SIDED|95.0|0.09|0.338|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.338|0.090|<0.0001
74030551|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.057||||0.0008|TWO_SIDED|95.0|1.023|1.091|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.091|1.023|0.0008
74030552|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.638||||0.0255|TWO_SIDED|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.946|0.431|0.0255
74030553|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.755||||0.0059|TWO_SIDED|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.922|0.618|0.0059
73866284|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.96|||||TWO_SIDED|95.0|-14.6|24.53|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||24.53|-14.60|
73866285|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|-4.51|35.63|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||35.63|-4.51|
74030554|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.521||||0.0005|TWO_SIDED|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.236|1.501|0.0005
73866286|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|23.18|||||TWO_SIDED|95.0|3.31|43.06|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||43.06|3.31|
73866287|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-5.13|||||TWO_SIDED|95.0|-24.73|14.45|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||14.45|-24.73|
73866288|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.34|||||TWO_SIDED|95.0|-23.79|15.09|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||15.09|-23.79|
73866289|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.04|||||TWO_SIDED|95.0|-16.94|23.02|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||23.02|-16.94|
73936298|NCT02347761|147402543|SUPERIORITY|In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|LS mean (SE)|0.1052|STANDARD_ERROR_OF_MEAN|0.0206|<|0.0001|TWO_SIDED|95.0|0.0647|0.1457|||LS mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1457|0.0647|<0.0001
73936299|NCT01040130|147402615|SUPERIORITY_OR_OTHER||Ratio to placebo|1.14|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|1.065|1.221|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo|||1.221|1.065|0.0002
73936300|NCT01040130|147402615|SUPERIORITY_OR_OTHER||Ratio to placebo|1.138|STANDARD_ERROR_OF_MEAN|0.04||0.0003||95.0|1.062|1.219|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo|||1.219|1.062|0.0003
73936301|NCT01040130|147402616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.112|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.252|0.112|<0.0001
73936302|NCT01040130|147402616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.104|0.245|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.245|0.104|<0.0001
74030555|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.602||||0.0011|TWO_SIDED|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.627|1.463|0.0011
73866290|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.59|||||TWO_SIDED|95.0|-14.26|25.45|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||25.45|-14.26|
73866291|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-34.1|||||TWO_SIDED|95.0|-53.4|-14.8|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-14.80|-53.40|
73866292|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.89|||||TWO_SIDED|95.0|-29.68|9.88|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||9.88|-29.68|
73866293|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.44|||||TWO_SIDED|95.0|-18.02|20.92|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||20.92|-18.02|
73866294|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-12.02|||||TWO_SIDED|95.0|-31.84|7.79|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||7.79|-31.84|
73866295|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-20.96|||||TWO_SIDED|95.0|-40.98|-0.94|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||-0.94|-40.98|
73866296|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-7.58|||||TWO_SIDED|95.0|-27.82|12.65|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||12.65|-27.82|
73866297|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.96|||||TWO_SIDED|95.0|-21.36|19.43|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||19.43|-21.36|
73866298|NCT01393639|147278682|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-18.22|||||TWO_SIDED|95.0|-38.18|1.73|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||1.73|-38.18|
73866299|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.27|||||TWO_SIDED|95.0|-11.93|7.38|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||7.38|-11.93|
73866300|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.87|||||TWO_SIDED|95.0|-9.15|12.91|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||12.91|-9.15|
73866301|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.07|||||TWO_SIDED|95.0|-9.09|13.23|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||13.23|-9.09|
73936303|NCT01040130|147402617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.766|STANDARD_ERROR_OF_MEAN|0.223||0.0007||95.0|-1.205|-0.326|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.326|-1.205|0.0007
73936304|NCT01040130|147402617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.634|STANDARD_ERROR_OF_MEAN|0.225||0.0051||95.0|-1.077|-0.192|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.192|-1.077|0.0051
73936305|NCT01040130|147402618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.258|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.191|0.325|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.325|0.191|<0.0001
74030556|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.727||||0.0034|TWO_SIDED|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.491|1.198|0.0034
73866302|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|18.71|||||TWO_SIDED|95.0|4.19|33.23|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||33.23|4.19|
73866303|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.59|||||TWO_SIDED|95.0|-13.19|4.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||4.00|-13.19|
73936306|NCT01040130|147402618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.294|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.226|0.362|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.362|0.226|<0.0001
73936307|NCT01040130|147402619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.107|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.252|0.107|<0.0001
73936308|NCT01040130|147402619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.037||0.0003||95.0|0.064|0.21|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.210|0.064|0.0003
74039415|NCT04847141|147632414|SUPERIORITY||LS Mean Difference|-0.01||||0.4128|TWO_SIDED|95.0|-0.05|0.02||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.02|-0.05|0.4128
73866304|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.74|||||TWO_SIDED|95.0|-0.92|26.41|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||26.41|-0.92|
73866305|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-14.6|10.16|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.16|-14.60|
73866306|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.29|||||TWO_SIDED|95.0|-2.9|27.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||27.48|-2.90|
73866307|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|24.44|||||TWO_SIDED|95.0|7.71|41.17|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||41.17|7.71|
73866308|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|16.54|||||TWO_SIDED|95.0|0.8|32.29|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||32.29|0.80|
73866309|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.98|12.98|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||12.98|-12.98|
73866310|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.32|||||TWO_SIDED|95.0|3.16|35.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||35.48|3.16|
73936309|NCT01040130|147402620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.103|STANDARD_ERROR_OF_MEAN|0.051||0.0447||95.0|-0.204|-0.002|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.002|-0.204|0.0447
73936310|NCT01040130|147402620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.064|STANDARD_ERROR_OF_MEAN|0.052||0.2132||95.0|-0.166|0.037|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.037|-0.166|0.2132
73866311|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.44|||||TWO_SIDED|95.0|-18.46|9.57|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||9.57|-18.46|
73866312|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.1|||||TWO_SIDED|95.0|-4.49|28.7|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||28.70|-4.49|
73866313|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|24.44|||||TWO_SIDED|95.0|6.63|42.24|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||42.24|6.63|
73936311|NCT01040130|147402621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.088|STANDARD_ERROR_OF_MEAN|0.154||0.5698||95.0|-0.391|0.216|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.216|-0.391|0.5698
73936312|NCT01040130|147402621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.155||0.1003||95.0|-0.05|0.561|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.561|-0.050|0.1003
73936313|NCT01040130|147402622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.122|STANDARD_ERROR_OF_MEAN|0.069||0.0784||95.0|-0.258|0.014|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.014|-0.258|0.0784
73936314|NCT01040130|147402622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.115|STANDARD_ERROR_OF_MEAN|0.07||0.1013||95.0|-0.252|0.023|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.023|-0.252|0.1013
73936315|NCT01040130|147402623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.066||0.0015||95.0|-0.339|-0.081|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.081|-0.339|0.0015
73972969|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|7.79||||0.657|TWO_SIDED|95.0|-26.77|42.36||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.44|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||42.36|-26.77|0.657
73866314|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|26.99|||||TWO_SIDED|95.0|9.33|44.65|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||44.65|9.33|
73936316|NCT01040130|147402623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|-0.503|-0.243|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.243|-0.503|<0.0001
73936317|NCT01040130|147402624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.034||0.0005||95.0|0.052|0.185|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.185|0.052|0.0005
73936318|NCT01040130|147402624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.034||0.0073||95.0|0.025|0.159|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.159|0.025|0.0073
73936319|NCT01040130|147402625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.136|0.275|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.275|0.136|<0.0001
73972970|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|-5.08||||0.627|TWO_SIDED|95.0|-25.72|15.56||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||15.56|-25.72|0.627
73972971|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.364|TWO_SIDED|95.0|-42.86|15.86||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.91|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||15.86|-42.86|0.364
73866315|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-7.53|25.31|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||25.31|-7.53|
73866316|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|21.4|||||TWO_SIDED|95.0|3.88|38.91|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||38.91|3.88|
73866317|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-6.8|24.57|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||24.57|-6.80|
73866318|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|18.58|||||TWO_SIDED|95.0|1.96|35.2|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||35.20|1.96|
73866319|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|35.55|||||TWO_SIDED|95.0|17.89|53.21|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||53.21|17.89|
73866320|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|29.21|||||TWO_SIDED|95.0|11.94|46.49|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||46.49|11.94|
73936320|NCT01040130|147402625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.146|0.285|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.285|0.146|<0.0001
73936321|NCT01040130|147402626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.062||0.9239||95.0|-0.115|0.127|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.127|-0.115|0.9239
73936322|NCT01040130|147402626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.062||0.7368||95.0|-0.144|0.102|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.102|-0.144|0.7368
73972972|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|-8.42||||0.574|TWO_SIDED|95.0|-38.0|21.15||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.56|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||21.15|-38.00|0.574
73972973|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|-5.51||||0.557|TWO_SIDED|95.0|-23.96|12.94||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -0.59|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||12.94|-23.96|0.557
73972974|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|-13.65||||0.302|TWO_SIDED|95.0|-39.64|12.35||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -1.03|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||12.35|-39.64|0.302
73972975|NCT02938923|147488334|SUPERIORITY||Mean Difference (Final Values)|-8.14||||0.541|TWO_SIDED|95.0|-34.33|18.06||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -0.61|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||18.06|-34.33|0.541
73972976|NCT02938923|147488335|SUPERIORITY||Mean Difference (Final Values)|357.72||||0.336|TWO_SIDED|95.0|-375.75|1091.19||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.97|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1091.19|-375.75|0.336
73936323|NCT01040130|147402627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.067||0.8302||95.0|-0.146|0.118|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.118|-0.146|0.8302
73972977|NCT02938923|147488335|SUPERIORITY||Mean Difference (Final Values)|936.93||||0.09|TWO_SIDED|95.0|-147.56|2021.42||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.71|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2021.42|-147.56|0.090
73972978|NCT02938923|147488335|SUPERIORITY||Mean Difference (Final Values)|579.21||||0.297|TWO_SIDED|95.0|-515.36|1673.78||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.05|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1673.78|-515.36|0.297
73972979|NCT02938923|147488335|SUPERIORITY||Mean Difference (Final Values)|383.36||||0.245|TWO_SIDED|95.0|-266.06|1032.79||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 1.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1032.79|-266.06|0.245
73972980|NCT02938923|147488335|SUPERIORITY||Mean Difference (Final Values)|836.64||||0.069|TWO_SIDED|95.0|-67.04|1740.32||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 1.84|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1740.32|-67.04|0.069
73972981|NCT02938923|147488335|SUPERIORITY||Mean Difference (Final Values)|453.28||||0.327|TWO_SIDED|95.0|-459.13|1365.68||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 0.98|Difference between changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1365.68|-459.13|0.327
73972982|NCT02938923|147488336|SUPERIORITY||Mean Difference (Final Values)|17.16||||0.934|TWO_SIDED|95.0|-391.74|426.05||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.08|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||426.05|-391.74|0.934
73972983|NCT02938923|147488336|SUPERIORITY||Mean Difference (Final Values)|562.64||||0.068|TWO_SIDED|95.0|-42.02|1167.31||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.84|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1167.31|-42.02|0.068
73972984|NCT02938923|147488336|SUPERIORITY||Mean Difference (Final Values)|545.49||||0.079|TWO_SIDED|95.0|-64.81|1155.79||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.77|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1155.79|-64.81|0.079
73866321|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|13.33|||||TWO_SIDED|95.0|-2.96|29.63|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||29.63|-2.96|
73936324|NCT01040130|147402627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159|STANDARD_ERROR_OF_MEAN|0.068||0.0202||95.0|-0.292|-0.025|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.025|-0.292|0.0202
73936325|NCT01040130|147402628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.056|0.123|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.123|0.056|<0.0001
73866322|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|32.31|||||TWO_SIDED|95.0|14.83|49.8|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||49.80|14.83|
73866323|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-15.79|15.79|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||15.79|-15.79|
73866324|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.49|||||TWO_SIDED|95.0|-12.67|19.67|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||19.67|-12.67|
73866325|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.66|||||TWO_SIDED|95.0|-10.13|23.47|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||23.47|-10.13|
73866326|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.75|||||TWO_SIDED|95.0|-16.25|14.74|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||14.74|-16.25|
73866327|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-8.19|25.96|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||25.96|-8.19|
73866328|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.13|||||TWO_SIDED|95.0|-10.5|22.77|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||22.77|-10.50|
73936326|NCT01040130|147402628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.068|0.134|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.134|0.068|<0.0001
73866329|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-15.01|||||TWO_SIDED|95.0|-28.03|-2.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||-2.00|-28.03|
73866330|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-10.86|||||TWO_SIDED|95.0|-24.93|3.19|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||3.19|-24.93|
73866331|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-10.67|||||TWO_SIDED|95.0|-24.83|3.48|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||3.48|-24.83|
73936327|NCT01040130|147402629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.191|0.258|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.258|0.191|<0.0001
73866332|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.96|||||TWO_SIDED|95.0|-10.96|22.9|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||22.90|-10.96|
73866333|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-21.54|||||TWO_SIDED|95.0|-37.22|-5.86|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-5.86|-37.22|
73866334|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-7.03|||||TWO_SIDED|95.0|-25.01|10.95|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||10.95|-25.01|
73866335|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.12|||||TWO_SIDED|95.0|-14.17|24.41|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||24.41|-14.17|
73866336|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.77|||||TWO_SIDED|95.0|-21.22|15.67|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||15.67|-21.22|
73866337|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-25.84|||||TWO_SIDED|95.0|-42.54|-9.14|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||-9.14|-42.54|
73866338|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.29|||||TWO_SIDED|95.0|-28.22|9.62|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||9.62|-28.22|
73866339|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.04|||||TWO_SIDED|95.0|-16.94|23.02|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||23.02|-16.94|
73866340|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.59|||||TWO_SIDED|95.0|-14.26|25.45|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||25.45|-14.26|
73866341|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-23.42|||||TWO_SIDED|95.0|-42.26|-4.59|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||-4.59|-42.26|
73866342|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-13.73|||||TWO_SIDED|95.0|-33.35|5.87|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||5.87|-33.35|
73866343|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.23|||||TWO_SIDED|95.0|-17.26|23.74|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||23.74|-17.26|
73866344|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-3.09|||||TWO_SIDED|95.0|-23.27|17.07|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||17.07|-23.27|
73866345|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.13|||||TWO_SIDED|95.0|-22.77|10.5|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||10.50|-22.77|
73936328|NCT01040130|147402629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.193|0.259|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.259|0.193|<0.0001
73972985|NCT02938923|147488336|SUPERIORITY||Mean Difference (Final Values)|33.73||||0.867|TWO_SIDED|95.0|-365.4|432.86||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 0.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||432.860|-365.40|0.867
73972986|NCT02938923|147488336|SUPERIORITY||Mean Difference (Final Values)|665.75||||0.02|TWO_SIDED|95.0|105.68|1225.81||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 2.36|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||1225.81|105.68|0.020
74030557|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.545||||0.0014|TWO_SIDED|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.792|0.376|0.0014
74030558|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.0042|TWO_SIDED|95.0|0.822|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.964|0.822|0.0042
74088870|NCT00680186|147730899|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.2||||0.083||95.0|0.0|0.5|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.5|0.0|0.0830
73936329|NCT01040130|147402630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.031||0.0006||95.0|0.046|0.167|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.167|0.046|0.0006
73936330|NCT01040130|147402630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.031||0.0017||95.0|0.037|0.158|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.158|0.037|0.0017
73972987|NCT02938923|147488336|SUPERIORITY||Mean Difference (Final Values)|632.02||||0.029|TWO_SIDED|95.0|66.38|1197.66||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 2.22|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||1197.66|66.38|0.029
73972988|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.946|TWO_SIDED|95.0|-19.61|21.01||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 0.07|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||21.01|-19.61|0.946
73972989|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|24.44||||0.094|TWO_SIDED|95.0|-4.25|53.13||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.69|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||53.13|-4.25|0.094
74088871|NCT00680186|147730900|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.1||||0.7348||95.0|-0.7|1.0|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.0|-0.7|0.7348
74088872|NCT00680186|147730900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8939||95.0|0.61|1.77|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.77|0.61|0.8939
74088873|NCT00680186|147730901|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.3||||0.321|TWO_SIDED|95.0|-1.0|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic fatal and non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.3|-1.0|0.3210
74088874|NCT00680186|147730901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.3021|TWO_SIDED|95.0|0.29|1.46|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.46|0.29|0.3021
74088875|NCT00680186|147730902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||||95.0|0.36|1.32|||Regression, Cox||This is the analysis of the time to the first MBE.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of MBE was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.32|0.36|
74088876|NCT00680186|147730902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||<|0.0001|TWO_SIDED|95.0|0.56|0.81|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of any bleeding was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||0.81|0.56|<0.0001
74088877|NCT00285584|147730937|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.5||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.9
73866346|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.63|||||TWO_SIDED|95.0|-19.63|14.35|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||14.35|-19.63|
73936331|NCT01040130|147402631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.285|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.227|0.342|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.342|0.227|<0.0001
73936332|NCT01040130|147402631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.233|0.348|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.348|0.233|<0.0001
73936333|NCT01040130|147402632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.207|0.429|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.429|0.207|<0.0001
73936334|NCT01040130|147402632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.303|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.192|0.414|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.414|0.192|<0.0001
73936335|NCT01040130|147402633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.585|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.47|0.701|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.701|0.470|<0.0001
73936336|NCT01040130|147402633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.618|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001||95.0|0.502|0.734|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.734|0.502|<0.0001
73972990|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|23.74||||0.107|TWO_SIDED|95.0|-5.19|52.67||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.63|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||52.67|-5.19|0.107
73972991|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|4.81||||0.627|TWO_SIDED|95.0|-14.68|24.3||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 0.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||24.30|-14.68|0.627
73972992|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|24.91||||0.072|TWO_SIDED|95.0|-2.2|52.01||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.81|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||52.01|-2.20|0.072
73972993|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|20.1||||0.149|TWO_SIDED|95.0|-7.29|47.49||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.45|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||47.49|-7.29|0.149
73972994|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|-1.38||||0.849|TWO_SIDED|95.0|-15.71|12.95||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = -0.19|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||12.95|-15.71|0.849
73972995|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|15.47||||0.134|TWO_SIDED|95.0|-4.83|35.78||Unadjusted p-value|Mixed Models Analysis|(df, 110) = 1.15|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||35.78|-4.83|0.134
73936337|NCT00553267|147402659|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001||95.0|-3.77|-1.75||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."||-1.75|-3.77|<0.0001
73972996|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|16.86||||0.107|TWO_SIDED|95.0|-3.68|37.39||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.63|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||37.39|-3.68|0.107
73972997|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.973|TWO_SIDED|95.0|-13.64|13.17||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = -0.03|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||13.17|-13.64|0.973
73972998|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|14.49||||0.135|TWO_SIDED|95.0|-4.56|33.54||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.50|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||33.54|-4.56|0.135
74030559|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.824||||0.0363|TWO_SIDED|95.0|0.687|0.988|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.687|0.0363
73866347|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.53|||||TWO_SIDED|95.0|-17.06|18.12|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||18.12|-17.06|
74030560|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.842||||0.0033|TWO_SIDED|95.0|0.751|0.944|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.944|0.751|0.0033
73936338|NCT00553267|147402659|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001||95.0|-3.86|-1.84||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."||-1.84|-3.86|<0.0001
73936339|NCT00553267|147402660|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|-5.15|-2.16|||ANCOVA|Adjusted for baseline and country effect||||-2.16|-5.15|<0.0001
73866348|NCT01393639|147278683|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.89|||||TWO_SIDED|95.0|-23.24|9.46|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||9.46|-23.24|
73866349|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||0.00|0.00|
73936340|NCT00553267|147402660|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|-5.35|-2.36|||ANCOVA|Adjusted for baseline and country effect||||-2.36|-5.35|<0.0001
73936341|NCT00553267|147402661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.002|TWO_SIDED|95.0|1.21|2.32|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.32|1.21|0.002
73936342|NCT00553267|147402661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91|||<|0.001||95.0|1.37|2.65|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.65|1.37|<0.001
73936343|NCT00553267|147402662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.004||95.0|1.3|4.25|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||4.25|1.30|0.004
73936344|NCT00553267|147402662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.004||95.0|1.29|4.22|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||4.22|1.29|0.004
73936345|NCT00553267|147402663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.002||95.0|1.21|2.34|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.34|1.21|0.002
73936346|NCT00553267|147402663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||<|0.001||95.0|1.38|2.68|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.68|1.38|<0.001
73936347|NCT00553267|147402664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.027||95.0|1.04|2.0|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.00|1.04|0.027
74030561|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.477||||0.0006|TWO_SIDED|95.0|1.183|1.844|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.844|1.183|0.0006
73866350|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.34|||||TWO_SIDED|95.0|-1.54|10.24|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||10.24|-1.54|
73866351|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-2.08|6.52|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||6.52|-2.08|
73936348|NCT00553267|147402664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.008||95.0|1.12|2.15|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.15|1.12|0.008
73936349|NCT00553267|147402665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.006||95.0|1.14|2.21|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.21|1.14|0.006
73936350|NCT00553267|147402665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.002||95.0|1.2|2.32|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.32|1.20|0.002
73866352|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.38|||||TWO_SIDED|95.0|-0.6|13.37|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||13.37|-0.60|
73866353|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-2.08|6.52|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||6.52|-2.08|
73866354|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.69|||||TWO_SIDED|95.0|0.55|16.83|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||16.83|0.55|
73866355|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||0.00|0.00|
73936351|NCT00553267|147402666|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test||||||0.006
73936352|NCT00553267|147402666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test||||||<0.001
73936353|NCT01136291|147402707|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The homogeneity between the groups was compared by the Student's t test or the Mann-Whitney test for continuous variables and chi-square for categorical variables.A comparison between values before and after the study group session was performed by the Student's t test. The effect of the exercise was evaluated by repeated measures ANOVA, where the effect of time and group were evaluated on pressure, weight, Body Mass Index (BMI)and World Health Organization Quality of Life Questionnarie domains.||||<0.05
73936354|NCT00780962|147402723|SUPERIORITY||Percentage Difference|0.6|||>|0.5|TWO_SIDED|95.0|-4.8|6.0|||Wald|||"The study was powered to find a 10% absolute risk reduction in the rate of contrast-induced nephropathy (a=.05, 90% power). We initially estimated the need for 600 patients and repowered to 800 patients after the 1st interim analysis. The study was halted for futility at the 2nd interim analysis.~Reported here 357 (89.4%) of the 399 enrolled subjects who completed a second blood draw at the time the study closed."||6.0|-4.8|>0.5
73936355|NCT01910519|147402744|OTHER|||||||0.0039|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M183-TBA at day 1 with MN titers at day 42||||0.0039
73936356|NCT01910519|147402744|OTHER|||||||0.0368|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M115-cytokines-receptors cluster at day 1 with MN titers at day 42||||0.0368
74039416|NCT04847141|147632416|SUPERIORITY||LS Mean Difference|-0.01||||0.9713|TWO_SIDED|95.0|-0.28|0.27||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.27|-0.28|0.9713
73936357|NCT01910519|147402744|OTHER|||||||0.0465|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M74-transcriptional targets of glucocorticoid receptor at day 1 with MN titers at day 42||||0.0465
73936358|NCT01910519|147402744|OTHER|||||||0.0411|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M58-B cell development/activation at day 1 with MN titers at day 42||||0.0411
73866356|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.51|||||TWO_SIDED|95.0|0.53|16.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||16.48|0.53|
73866357|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|4.96|26.14|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||26.14|4.96|
74039417|NCT04847141|147632416|SUPERIORITY||LS Mean Difference|0.07||||0.5985|TWO_SIDED|95.0|-0.2|0.35||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.35|-0.20|0.5985
73936359|NCT01910519|147402744|OTHER|||||||0.0067|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M114.0-TBA at day 1 with MN titers at day 42||||0.0067
73936360|NCT03176693|147402745|EQUIVALENCE|A power analysis was calculated based on findings reported by Weingarten et al. of more frequent episodes of hypotension (defined as difference of mean systolic blood pressure \<30% from baseline) in phenoxybenzamine compared with doxazosin (15.7% versus 5.1%). Using a standard deviation of 16 and 11 (derived from reported interquartile ranges, assuming normal distribution), respectively, to achieve 80% power using an alpha =.05, a total sample size of 56 patients was determined.||||||0.56||||||Threshold for statistical significance = 0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis: hemodynamic instability time will not differ between arms||||.56
73936361|NCT04266028|147402751|OTHER|No statistical analyses were performed.|no statistical analyses were performed|0.0|||||TWO_SIDED|||||No statistical analyses were performed||||No statistical analyses were performed.|No statistical analyses were performed.|||
73936362|NCT02279641|147402755|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|133.0|||||TWO_SIDED|90.0|111.0|159.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||159|111|
73936363|NCT02279641|147402755|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|67.9|||||TWO_SIDED|90.0|65.2|70.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||70.7|65.2|
73936364|NCT02279641|147402757|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||TWO_SIDED|90.0|93.3|111.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||111|93.3|
73936365|NCT02279641|147402757|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||TWO_SIDED|90.0|58.1|65.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||65.7|58.1|
73972999|NCT02938923|147488337|SUPERIORITY||Mean Difference (Final Values)|14.72||||0.134|TWO_SIDED|95.0|-4.55|34.0||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.51|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||34.00|-4.55|0.134
73866358|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.02|||||TWO_SIDED|95.0|6.27|27.76|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||27.76|6.27|
73936366|NCT02279641|147402757|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|90.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
73936367|NCT02279641|147402758|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||TWO_SIDED|90.0|94.9|112.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||112|94.9|
73936368|NCT02279641|147402758|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||TWO_SIDED|90.0|58.1|65.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||65.7|58.1|
73936369|NCT02279641|147402760|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|89.5|||||TWO_SIDED|90.0|81.8|98.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||98.0|81.8|
73936370|NCT02279641|147402760|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|119.0|||||TWO_SIDED|90.0|114.0|125.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||125|114|
73936371|NCT02279641|147402761|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|87.5|||||TWO_SIDED|90.0|79.3|96.6|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||96.6|79.3|
73936372|NCT02279641|147402761|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|193.0|||||TWO_SIDED|90.0|177.0|210.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||210|177|
73936373|NCT02279641|147402761|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|105.0|||||TWO_SIDED|90.0|94.4|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||117|94.4|
73936374|NCT02279641|147402764|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.7|||||TWO_SIDED|95.0|87.7|111.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||111|87.7|
73936375|NCT02279641|147402765|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|95.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
73936376|NCT02279641|147402766|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|95.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
74088878|NCT00285584|147730938|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.5||||0.3|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank test||||0.3
73866359|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.44|||||TWO_SIDED|95.0|-1.57|10.46|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.46|-1.57|
73973000|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|1.21||||0.125|TWO_SIDED|95.0|-0.34|2.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.55|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2.76|-0.34|0.125
73973001|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.758|TWO_SIDED|95.0|-1.9|2.61||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.31|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2.61|-1.90|0.758
73973002|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.455|TWO_SIDED|95.0|-3.12|1.41||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.75|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1.41|-3.12|0.455
73973003|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.229|TWO_SIDED|95.0|-0.72|3.0||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 1.21|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||3.00|-0.72|0.229
73866360|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.21|||||TWO_SIDED|95.0|4.83|25.59|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||25.59|4.83|
73866361|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-9.62|5.18|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||5.18|-9.62|
73866362|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.32|||||TWO_SIDED|95.0|-2.96|19.6|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||19.60|-2.96|
73866363|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-2.72|20.5|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||20.50|-2.72|
73866364|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.57|||||TWO_SIDED|95.0|0.26|24.89|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||24.89|0.26|
73973004|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.647|TWO_SIDED|95.0|-1.97|3.16||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.46|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||3.16|-1.97|0.647
73973005|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.68|TWO_SIDED|95.0|-3.12|2.04||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -0.41|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.04|-3.12|0.680
73973006|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|1.48||||0.052|TWO_SIDED|95.0|-0.02|2.97||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.96|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||2.97|-0.02|0.052
73973007|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.754|TWO_SIDED|95.0|-1.79|2.46||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.31|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||2.46|-1.79|0.754
73973008|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|-1.14||||0.294|TWO_SIDED|95.0|-3.28|1.0||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.06|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||1.00|-3.28|0.294
73973009|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|1.46||||0.031|TWO_SIDED|95.0|0.13|2.78||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.78|0.13|0.031
73973010|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.752|TWO_SIDED|95.0|-1.56|2.16||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.32|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.16|-1.56|0.752
74088879|NCT00285584|147730939|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.15||||0.3|TWO_SIDED|95.0|0.4|27.8|||Fisher Exact|||Comparison of cumulative incidence proportions||27.8|0.4|0.3
74088880|NCT00285584|147730940|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.5||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
74088881|NCT00645944|147730941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.039|TWO_SIDED|95.0|-7.5|-0.2|||Mixed Models Analysis|||||-0.2|-7.5|0.039
73973011|NCT02938923|147488338|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.223|TWO_SIDED|95.0|-3.03|0.71||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.22|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||0.71|-3.03|0.223
73973012|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.006|TWO_SIDED|95.0|0.24|1.46||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 2.78|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1.46|0.24|0.006
73973013|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.863|TWO_SIDED|95.0|-0.81|0.97||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.17|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.97|-0.81|0.863
73936377|NCT02279641|147402767|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||TWO_SIDED|95.0|86.7|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||117|86.7|
73973014|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.091|TWO_SIDED|95.0|-1.67|0.12||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.71|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.12|-1.67|0.091
73973015|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.009|TWO_SIDED|95.0|0.21|1.44||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.65|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.44|0.21|0.009
73973016|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.778|TWO_SIDED|95.0|-0.76|1.02||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.28|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.02|-0.76|0.778
73973017|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.124|TWO_SIDED|95.0|-1.59|0.19||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.55|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.19|-1.59|0.124
73973018|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.027|TWO_SIDED|95.0|0.08|1.31||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 2.24|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||1.31|0.08|0.027
73973019|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.833|TWO_SIDED|95.0|-0.97|0.78||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.21|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.78|-0.97|0.833
73973020|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.08|TWO_SIDED|95.0|-1.67|0.1||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.77|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.10|-1.67|0.080
74030562|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.128||||0.381|TWO_SIDED|95.0|0.862|1.477|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.477|0.862|0.3810
73973021|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.014|TWO_SIDED|95.0|0.14|1.21||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.21|0.14|0.014
74030563|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.812||||0.0279|TWO_SIDED|95.0|0.674|0.978|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.978|0.674|0.0279
74039418|NCT04847141|147632416|SUPERIORITY||LS Mean Difference|0.01||||0.9209|TWO_SIDED|95.0|-0.25|0.28||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.28|-0.25|0.9209
73973022|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.834|TWO_SIDED|95.0|-0.84|0.68||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -0.21|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.68|-0.84|0.834
73973023|NCT02938923|147488339|SUPERIORITY||Mean Difference (Final Values)|-0.75||||0.054|TWO_SIDED|95.0|-1.52|0.01||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.94|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.01|-1.52|0.054
73973024|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.326|TWO_SIDED|95.0|-0.25|0.74||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.99|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.74|-0.25|0.326
73973025|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.587|TWO_SIDED|95.0|-0.87|0.49||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.54|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.49|-0.87|0.587
73973026|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.213|TWO_SIDED|95.0|-1.12|0.25||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.25|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.25|-1.12|0.213
73973027|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.41|TWO_SIDED|95.0|-0.32|0.78||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.83|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.78|-0.32|0.410
73936378|NCT03021187|147402768|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.7|< 0.0001
73936379|NCT03021187|147402768|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.7|-1.1|< 0.0001
73936380|NCT03021187|147402768|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.0|-1.4|< 0.0001
73973028|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.527|TWO_SIDED|95.0|-0.99|0.51||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.63|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.51|-0.99|0.527
73973029|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.219|TWO_SIDED|95.0|-1.23|0.28||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.23|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.28|-1.23|0.219
73973030|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.355|TWO_SIDED|95.0|-0.25|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.93|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.69|-0.25|0.355
73973031|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.554|TWO_SIDED|95.0|-0.88|0.47||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.59|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.47|-0.88|0.554
73973032|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.219|TWO_SIDED|95.0|-1.1|0.26||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.24|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.26|-1.10|0.219
73973033|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.345|TWO_SIDED|95.0|-0.24|0.68||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.95|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.68|-0.24|0.345
74030564|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|45.894|||<|0.0001|TWO_SIDED|95.0|27.972|75.299|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||75.299|27.972|<0.0001
74030565|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|32.176|||<|0.0001|TWO_SIDED|95.0|20.129|51.434|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||51.434|20.129|<0.0001
74030566|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.928|||<|0.0001|TWO_SIDED|95.0|4.291|11.188|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.188|4.291|<0.0001
74030567|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.733||||0.0204|TWO_SIDED|95.0|0.564|0.953|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.953|0.564|0.0204
73866365|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-7.23|11.67|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||11.67|-7.23|
73866366|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.29|||||TWO_SIDED|95.0|3.94|30.64|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||30.64|3.94|
73936381|NCT03021187|147402768|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
73866367|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-14.6|10.16|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||10.16|-14.60|
73866368|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.91|||||TWO_SIDED|95.0|-8.22|20.04|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||20.04|-8.22|
73866369|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|-0.29|31.4|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||31.40|-0.29|
73866370|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|10.16|||||TWO_SIDED|95.0|-4.7|25.03|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||25.03|-4.70|
73866371|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.44|||||TWO_SIDED|95.0|-16.16|7.27|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||7.27|-16.16|
73866372|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.97|||||TWO_SIDED|95.0|-0.68|30.63|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||30.63|-0.68|
73866373|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||10.30|-10.30|
73936382|NCT03021187|147402768|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.2|<0.0001
73973034|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.494|TWO_SIDED|95.0|-0.88|0.43||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.69|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.43|-0.88|0.494
73973035|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.18|TWO_SIDED|95.0|-1.11|0.21||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.35|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.21|-1.11|0.180
73866374|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.09|||||TWO_SIDED|95.0|-5.9|18.1|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||18.10|-5.90|
73866375|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||10.30|-10.30|
73866376|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.84|||||TWO_SIDED|95.0|-8.96|12.64|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||12.64|-8.96|
73866377|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.44|||||TWO_SIDED|95.0|-7.27|16.16|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||16.16|-7.27|
73866378|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.2|||||TWO_SIDED|95.0|-7.37|15.77|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||15.77|-7.37|
73866379|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.69|||||TWO_SIDED|95.0|-16.83|-0.55|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||-0.55|-16.83|
73866380|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.34|||||TWO_SIDED|95.0|-14.39|5.7|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||5.70|-14.39|
73866381|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.47|||||TWO_SIDED|95.0|-15.68|2.73|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||2.73|-15.68|
73866382|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.31|||||TWO_SIDED|95.0|-13.04|8.41|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||8.41|-13.04|
73866383|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-15.21|||||TWO_SIDED|95.0|-25.59|-4.83|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-4.83|-25.59|
73866384|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.7|||||TWO_SIDED|95.0|-19.79|6.38|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||6.38|-19.79|
73866385|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.33|||||TWO_SIDED|95.0|-14.49|15.16|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||15.16|-14.49|
73936383|NCT03021187|147402768|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.6|<0.0001
73936384|NCT03021187|147402769|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9||||0.0392|TWO_SIDED|95.0|-1.8|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.0|-1.8|0.0392
73973036|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.693|TWO_SIDED|95.0|-0.75|0.5||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.4|Difference between the changes of IADL of EX+T - EX+P|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.50|-0.75|0.693
73973037|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.327|TWO_SIDED|95.0|-1.27|0.43||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.98|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.43|-1.27|0.327
73973038|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.493|TWO_SIDED|95.0|-1.15|0.56||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.69|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.56|-1.15|0.493
73973039|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.698|TWO_SIDED|95.0|-0.72|0.49||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.39|Difference between the IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.49|-0.72|0.698
73973040|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.404|TWO_SIDED|95.0|-1.17|0.47||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.84|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.47|-1.17|0.404
73973041|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.585|TWO_SIDED|95.0|-1.06|0.6||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.55|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.60|-1.06|0.585
73973042|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.399|TWO_SIDED|95.0|-0.31|0.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.85|Difference between IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.76|-0.31|0.399
73866386|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.8|||||TWO_SIDED|95.0|-13.13|16.74|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||16.74|-13.13|
73866387|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-19.51|||||TWO_SIDED|95.0|-32.19|-6.84|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||-6.84|-32.19|
73936385|NCT03021187|147402769|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.0||||0.0001|TWO_SIDED|95.0|-3.0|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.0|-3.0|0.0001
73936386|NCT03021187|147402769|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.2|-2.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-2.3|-4.2|<0.0001
73936387|NCT03021187|147402769|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.9||||0.0111|TWO_SIDED|95.0|-1.6|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-1.6|0.0111
73936388|NCT03021187|147402769|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.8|-3.2|<0.0001
73936389|NCT03021187|147402769|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.4|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-3.0|-4.4|<0.0001
73936390|NCT03021187|147402789|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.73||||0.0627|TWO_SIDED|95.0|0.53|1.02||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.02|0.53|0.0627
73973043|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.554|TWO_SIDED|95.0|-0.53|0.98||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.59|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.98|-0.53|0.554
73973044|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.76|0.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.76|-0.76|0.998
73973045|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.378|TWO_SIDED|95.0|-0.28|0.73||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.88|Difference between the IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.73|-0.28|0.378
74030568|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.087|0.331|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.331|0.087|<0.0001
73936391|NCT03021187|147402789|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.0083|TWO_SIDED|95.0|0.44|0.89||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.89|0.44|0.0083
73936392|NCT03021187|147402789|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.57||||0.0019|TWO_SIDED|95.0|0.4|0.81||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.81|0.40|0.0019
73936393|NCT03021187|147402790|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.121|TWO_SIDED|95.0|0.53|1.08||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.08|0.53|0.1210
73936394|NCT03021187|147402790|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.0007|TWO_SIDED|95.0|0.32|0.74||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.74|0.32|0.0007
73936395|NCT03021187|147402790|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0006|TWO_SIDED|95.0|0.31|0.73||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.73|0.31|0.0006
73936396|NCT01664078|147402805|OTHER|The Intent-to-Treat (ITT) analysis set includes all subjects who had the aortic bifurcate device introduced into the body. This ITT analysis set will be used for all safety and clinical assessment endpoints.||||||0.47|||||||Mixed Models Analysis|||||||0.47
73936397|NCT01422070|147402821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63|||<|0.05|TWO_SIDED|95.0|0.45|0.88|||generalized estimating equation|Generalized estimating equation adjusts the confidence interval for the correlation of outcomes within-centre.|The fully adjusted multivariable logistic regression analysis showed an OR of 0.63 in favour of the presence of an intermediate care unit in the hospital|The null hypothesis was that hospital mortality of patients admitted to intensive care units with intermediate care unit in the hospital is similar to that of the patients admitted to intensive care units without intermediate care unit in the hospital||0.88|0.45|<0.05
73936398|NCT03351049|147402822|SUPERIORITY|||||||0.8|||||||Chi-squared|||Compare the effectiveness of reactive support surfaces with and without low air loss in preventing pressure injuries||||0.8
73936399|NCT03762135|147402824|SUPERIORITY|||||||0.044||||||This relates to the entirety of the 6-week period.|GEE Linear Regression|Generalized Estimation Equation Linear Regression||||||0.044
73936400|NCT01812044|147402831|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.035
73936401|NCT01812044|147402831|SUPERIORITY_OR_OTHER|||||||0.189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.189
73936402|NCT01812044|147402831|SUPERIORITY_OR_OTHER|||||||0.298|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.298
73936403|NCT00364858|147402872|SUPERIORITY_OR_OTHER||Agresti and Min|-0.176||||||95.0|-0.357|0.058||||||Difference in proportion of Clinical Success = (Proportion of participants with Clinical Success Q4 - Proportion of participants with Clinical Success Q2).||0.058|-0.357|
73936404|NCT02730819|147402893|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.||||0.006
73936405|NCT02730819|147402894|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.||||0.006
73936406|NCT02099006|147402934|SUPERIORITY_OR_OTHER|||||||0.3|||||||t-test, 2 sided|Paired T test||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of loperamide than with the daily application of a placebo cream.||||0.30
73936407|NCT02099006|147402934|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketamine than with the daily application of a placebo cream.||||0.33
73936408|NCT02099006|147402934|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of gabapentin than with the daily application of a placebo cream.||||0.65
73936409|NCT02099006|147402934|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of amitriptyline and baclofen than with the daily application of a placebo cream.||||0.25
73936410|NCT02099006|147402934|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketoprofen than with the daily application of a placebo cream.||||1.0
73936411|NCT02099006|147402935|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of loperamide cream than with the daily application of a placebo cream.||||0.31
73936412|NCT02099006|147402935|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketamine cream than with the daily application of a placebo cream.||||1
73936413|NCT02099006|147402935|SUPERIORITY_OR_OTHER|||||||0.66|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of gabapentin cream than with the daily application of a placebo cream.||||0.66
73936414|NCT02099006|147402935|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketoprofen cream than with the daily application of a placebo cream.||||0.42
73936415|NCT02099006|147402935|SUPERIORITY_OR_OTHER|||||||0.79|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of amitriptyline/baclofen cream than with the daily application of a placebo cream.||||0.79
73957840|NCT00646451|147451208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162|||||||ANOVA|||"Outcome on study completers was assessed via ANOVA models using a 2 × 2 Latin-square crossover design including sequence, period, and treatment effects. A significant carryover effect was excluded. Analyses were performed using Stata IC version 10.0 for Windows.~Unfortunately the small sample size of our study limits the possibility of a meaningful post-hoc analysis targeted to these variables."|The Quest rates patient perception of health status as influenced by tremor across 5 domains, physical, psychosocial, communication, hobbies/leisure, and work/finance. HAM-A rates severity of anxiety symptomatology across 14 parameters. Scores of 14-17 correspond to mild anxiety, scores of 18-24 is moderate anxiety and 25-30 severe anxiety. HD-16 rates insomnia-related QoL across 5 domains: physical symptoms, energy \& motivation, concentration, interpersonal relations and psychological symptoms. These scales were scored per published guidelines.|||0.162
73957841|NCT01249092|147451243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-57.3|STANDARD_DEVIATION|62.1||0.001|TWO_SIDED|95.0|-88.2|-26.4||This study tested the hypothesis that treatment with pentoxifylline would result in a statistically significant change from baseline in the level of alkaline phosphatase.|Paired t-test|||A p-value \< 0.05 was considered statistically significant and all analyses were carried out using SAS version 9.2 (The SAS Institute, Cary, NC). Matched pairs t-test was used to compare the change in alkaline phosphatase from baseline. The efficacy of therapy was measured based on improvement in AP levels after therapy with PTX. AP levels at end of the study were compared with values at baseline by matched pairs t-test.||-26.4|-88.2|0.001
73957842|NCT01249092|147451244|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.69|STANDARD_ERROR_OF_MEAN|8.66||0.5|TWO_SIDED|95.0|-24.14|8.68||Hypothesis tested if TIMP-1 levels after therapy with pentoxifylline changed significantly from baseline from baseline.|Paired t-test.|||Change from baseline in TIMP-1 levels was assessed by paired-t test. Distribution the variable values was assessed using normal probability plots. Matched pairs t-test was used to compare the change from baseline.||8.68|-24.14|0.5
73957843|NCT02715258|147451249|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0012|TWO_SIDED|95.0|-0.66|-0.16||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|Mixed Models Analysis|||Analysis of change from baseline in HbA1c (%) at Week 24||-0.16|-0.66|0.0012
73957844|NCT02715258|147451249|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0021|TWO_SIDED|95.0|-0.68|-0.15||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in HbA1c (%) including observations obtained after rescue medication||-0.15|-0.68|0.0021
73957845|NCT02715258|147451249|SUPERIORITY||mixed-effects repeated measures|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|Mixed Models Analysis|||Sensitivity Analysis 2: Multiple imputation for change from baseline in HbA1c (%) excluding observations obtained after rescue medication||-0.30|-0.80|<0.0001
73957846|NCT02715258|147451249|SUPERIORITY||mixed-effects repeated measures|-0.4||||0.0009|TWO_SIDED|95.0|-0.64|-0.17||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 3: LOCF for change from baseline in HbA1c (%) including observations obtained after rescue medication||-0.17|-0.64|0.0009
73957847|NCT02715258|147451250|SUPERIORITY||mixed-effects repeated measures|-2.14||||0.234|TWO_SIDED|95.0|-5.66|1.39||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in SBP (mm Hg) at Week 24||1.39|-5.66|0.2340
73957848|NCT02715258|147451250|SUPERIORITY||mixed-effects repeated measures|-1.91||||0.2937|TWO_SIDED|95.0|-5.48|1.66||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in SBP (mm Hg) including observations obtained after rescue medication||1.66|-5.48|0.2937
73957849|NCT02715258|147451250|SUPERIORITY||mixed-effects repeated measures|-1.72||||0.403|TWO_SIDED|95.0|-5.75|2.32||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 2: Multiple imputation for change from baseline in SBP (mm Hg) excluding observations obtained after rescue medication||2.32|-5.75|0.4030
73957850|NCT02715258|147451250|SUPERIORITY||mixed-effects repeated measures|-2.09||||0.216|TWO_SIDED|95.0|-5.41|1.23||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||||1.23|-5.41|0.2160
73866388|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.97|||||TWO_SIDED|95.0|-24.24|6.29|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||6.29|-24.24|
73866389|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.4|||||TWO_SIDED|95.0|-23.92|7.1|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||7.10|-23.92|
73936416|NCT05349617|147402947|SUPERIORITY||Percent Difference|86.2|||<|0.0001|TWO_SIDED|95.0|80.0|90.3||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. Both coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|Day 22||90.3|80|<0.0001
73936417|NCT05349617|147402948|SUPERIORITY||[GMT Ratio]|90.0|||<|0.0001|TWO_SIDED|95.0|69.0|117.0||Both coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo).|Day 22||117|69|<0.0001
73936418|NCT05349617|147402954|SUPERIORITY||Percent Difference|79.5|||<|0.0001|TWO_SIDED|95.0|72.3|84.6||Key secondary endpoints were tested hierarchically (Day 15 tested prior to Day 183), such that each was only tested if both coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 15||84.6|72.3|<0.0001
73936419|NCT05349617|147402954|SUPERIORITY||Percent Difference|74.4|||<|0.0001|TWO_SIDED|95.0|67.1|80.1||Key secondary endpoints were tested hierarchically (Day 15 tested prior to Day 183), such that each was only tested if both coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 183||80.1|67.1|<0.0001
73936420|NCT05349617|147402955|SUPERIORITY||[GMT Ratio]|42.0|||<|0.0001|TWO_SIDED|95.0|32.0|56.0|||ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo)|Day 15||56|32|<0.0001
73936421|NCT05349617|147402955|SUPERIORITY||[GMT Ratio]|28.0|||<|0.0001|TWO_SIDED|95.0|22.0|35.0|||ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo)|Day 183||35|22|<0.0001
73936422|NCT05349617|147402956|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 15||||<0.0001
74030569|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.806||||0.001|TWO_SIDED|95.0|1.514|5.201|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.201|1.514|0.0010
74030570|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.663||||0.0459|TWO_SIDED|95.0|0.443|0.993|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.993|0.443|0.0459
73866390|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.71|||||TWO_SIDED|95.0|-20.76|11.32|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||11.32|-20.76|
73866391|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-17.19|||||TWO_SIDED|95.0|-32.36|-2.02|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||-2.02|-32.36|
73866392|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.06|||||TWO_SIDED|95.0|-25.69|7.56|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||7.56|-25.69|
73866393|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.57|||||TWO_SIDED|95.0|-17.53|18.68|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||18.68|-17.53|
73866394|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.81|||||TWO_SIDED|95.0|-22.07|12.45|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||12.45|-22.07|
73936423|NCT05349617|147402956|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 22||||<0.0001
73866395|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-15.77|7.37|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||7.37|-15.77|
73936424|NCT05349617|147402956|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 183||||<0.0001
73936425|NCT05349617|147402957|SUPERIORITY||Percent Difference|91.6|||<|0.0001|TWO_SIDED|95.0|86.0|94.6|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 15||94.6|86.0|<0.0001
73936426|NCT05349617|147402957|SUPERIORITY||Percent Difference|94.1|||<|0.0001|TWO_SIDED|95.0|89.2|96.5|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 22||96.5|89.2|<0.0001
74030571|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.758||||0.0087|TWO_SIDED|95.0|0.616|0.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.932|0.616|0.0087
73866396|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.89|||||TWO_SIDED|95.0|-11.21|15.0|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||15.00|-11.21|
73866397|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-15.77|7.37|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||7.37|-15.77|
73866398|NCT01393639|147278684|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.35|||||TWO_SIDED|95.0|-14.38|9.66|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||9.66|-14.38|
73866399|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.13|||||TWO_SIDED|95.0|-4.19|-0.07||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.07|-4.19|
73936427|NCT05349617|147402957|SUPERIORITY||Percent Difference|91.8|||<|0.0001|TWO_SIDED|95.0|86.3|94.8|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 183||94.8|86.3|<0.0001
73936428|NCT05349617|147402957|SUPERIORITY||Percent Difference|82.8|||<|0.0001|TWO_SIDED|95.0|75.9|87.5||p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|Chi-squared||SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 15||87.5|75.9|<0.0001
73936429|NCT05349617|147402957|SUPERIORITY||Percent Difference|88.3|||<|0.0001|TWO_SIDED|95.0|82.4|92.0|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 22||92.0|82.4|<0.0001
73936430|NCT05349617|147402957|SUPERIORITY||Percent Difference|82.0|||<|0.0001|TWO_SIDED|95.0|75.2|86.8|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 183||86.8|75.2|<0.0001
74030572|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.054||||0.0064|TWO_SIDED|95.0|1.224|3.447|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.447|1.224|0.0064
74030573|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.931||||0.0271|TWO_SIDED|95.0|1.077|3.461|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.461|1.077|0.0271
74030574|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.738||||0.0039|TWO_SIDED|95.0|1.194|2.528|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.528|1.194|0.0039
74030575|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.565||||0.0035|TWO_SIDED|95.0|0.386|0.829|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.829|0.386|0.0035
73866400|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.6|||||TWO_SIDED|95.0|-5.63|-1.57||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.57|-5.63|
73866401|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.02|||||TWO_SIDED|95.0|-5.06|-0.97||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.97|-5.06|
73936431|NCT00492349|147402962|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||<0.05
73936432|NCT00492349|147402963|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||||||All treatment main and interaction effect p-values were \> 0.05.|ANCOVA|||Mixed model ANCOVA in which baseline CPT Detectability served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||>0.05
73936433|NCT00492349|147402964|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline Antisaccade Errors served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||<0.05
73936434|NCT05732454|147402992|SUPERIORITY||Difference in percentage|-3.76|||=|0.558|TWO_SIDED|95.0|-16.36|8.83|||Cochran-Mantel-Haenszel|||Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.||8.83|-16.36|=0.5580
73936435|NCT05732454|147402993|SUPERIORITY||Difference in percentage|9.07|||=|0.3685|TWO_SIDED|95.0|-10.7|28.85|||Cochran-Mantel-Haenszel|||Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.||28.85|-10.70|=0.3685
73973046|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.608|TWO_SIDED|95.0|-0.53|0.91||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.51|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.91|-0.53|0.608
73973047|NCT02938923|147488340|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.915|TWO_SIDED|95.0|-0.76|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.11|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.69|-0.76|0.915
73973048|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.602|TWO_SIDED|95.0|-1.36|2.33||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.52|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||2.33|-1.36|0.602
73973049|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.454|TWO_SIDED|95.0|-3.48|1.56||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.75|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||1.56|-3.48|0.454
73973050|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|-1.45||||0.262|TWO_SIDED|95.0|-3.98|1.09||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -1.13|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||1.09|-3.98|0.262
73973051|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.639|TWO_SIDED|95.0|-1.47|2.4||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.47|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.40|-1.47|0.639
73973052|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.438|TWO_SIDED|95.0|-3.66|1.59||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.78|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.59|-3.66|0.438
73973053|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.265|TWO_SIDED|95.0|-4.14|1.14||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -1.12|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.14|-4.14|0.265
73973054|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.555|TWO_SIDED|95.0|-1.11|2.07||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.59|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||2.07|-1.11|0.555
73973055|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.917|TWO_SIDED|95.0|-2.39|2.15||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.10|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||2.15|-2.39|0.917
73973056|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.606|TWO_SIDED|95.0|-2.87|1.68||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.52|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||1.68|-2.87|0.606
73973057|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.549|TWO_SIDED|95.0|-1.09|2.04||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.60|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.04|-1.09|0.549
73973058|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.887|TWO_SIDED|95.0|-2.38|2.06||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.14|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.06|-2.38|0.887
73973059|NCT02938923|147488341|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.574|TWO_SIDED|95.0|-2.87|1.59||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.56|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.59|-2.87|0.574
74039419|NCT04847141|147632416|SUPERIORITY||LS Mean Difference|-0.01||||0.9181|TWO_SIDED|95.0|-0.28|0.25||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.25|-0.28|0.9181
73936436|NCT05732454|147402994|SUPERIORITY||Difference in Mean|-29.22|||=|0.0303|TWO_SIDED|95.0|-55.53|-2.9|||Rubin's rule|||Jump-to-Control (JTC) method was used for evaluation. A complete imputed dataset was analyzed using analysis of covariance model including effects of treatment group, actual stratification factor, and baseline value. Multiple results of the treatment comparison were combined using Rubin's rules, reporting the combined treatment difference, its standard error, 95% CI and 2-sided p-value, across the visits.||-2.90|-55.53|=0.0303
73866402|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-5.73|-1.68||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-5.73|
73866403|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.93|||||TWO_SIDED|95.0|-3.97|0.12||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.12|-3.97|
73866404|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.43|||||TWO_SIDED|95.0|-5.46|-1.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.39|-5.46|
73936437|NCT01153633|147403009|SUPERIORITY_OR_OTHER|||||||0.2317||95.0||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test|||||||0.2317
73936438|NCT01153633|147403013|SUPERIORITY_OR_OTHER|||||||0.4905||95.0|||||Fisher Exact|||||||0.4905
73936439|NCT01153633|147403014|SUPERIORITY_OR_OTHER|||||||0.9945||95.0||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test|||||||0.9945
74030576|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.533||||0.0071|TWO_SIDED|95.0|1.593|19.219|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||19.219|1.593|0.0071
73936440|NCT00384085|147403015|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.56||||0.0628|TWO_SIDED|95.0|0.97|2.52||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic|||||2.52|0.97|0.0628
73936441|NCT00384085|147403016|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of Lantus/Apidra-1 would be established if the upper limit of the 2 sided, 99.75% CI for the difference in the mean change from baseline between Lantus/Apidra-1 and Novolog Mix 70/30 was \<0.5%.|Adjusted Mean of difference|-0.34||||0.0359|TWO_SIDED|95.0|-0.82|0.15||The type I error was controlled by performing a 2-tailed comparison at a p=0.0025 level for noninferiority testing.|Mixed Models Analysis|||||0.15|-0.82|0.0359
73866405|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-4.03|0.42||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-4.03|
73866406|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.83|||||TWO_SIDED|95.0|-5.04|-0.62||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.62|-5.04|
73936442|NCT00384085|147403017|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.66||||0.0313|TWO_SIDED|95.0|1.04|2.64||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic|||||2.64|1.04|0.0313
73936443|NCT00384085|147403018|SUPERIORITY_OR_OTHER||Adjusted Mean of difference|-0.31||||0.0565|TWO_SIDED|95.0|-0.63|0.01|||ANCOVA|||||0.01|-0.63|0.0565
73936444|NCT00384085|147403019|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.79||||0.014|TWO_SIDED|95.0|1.12|2.85|||Regression, Logistic|||||2.85|1.12|0.0140
73936445|NCT00384085|147403020|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.02||||0.9268|TWO_SIDED|95.0|0.61|1.71|||Regression, Logistic|||||1.71|0.61|0.9268
73936446|NCT00384085|147403020|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.11||||0.0107|TWO_SIDED|95.0|1.19|3.73|||Regression, Logistic|||||3.73|1.19|0.0107
73936447|NCT00384085|147403020|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.06||||0.0121|TWO_SIDED|95.0|1.17|3.61|||Regression, Logistic|||||3.61|1.17|0.0121
73936448|NCT04837482|147403027|NON_INFERIORITY|Noninferiority of AGN-190584 was concluded if the lower bound of the 95% CI of the least-square mean difference between AGN-190584 and vehicle was greater than the pre-specified margin of -0.25.|Least-Square (LS) Mean|-0.224|STANDARD_ERROR_OF_MEAN|0.0602||0.0006|TWO_SIDED|95.0|-0.346|-0.103|||Mixed Models Analysis|Linear mixed-effects model with repeated measures||||-0.103|-0.346|0.0006
73936449|NCT00987467|147403031|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
73936450|NCT02646423|147403042|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.84|1.05||||||||1.05|0.84|
73936451|NCT02646423|147403043|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.86|1.16||||||||1.16|0.86|
73936452|NCT02646423|147403044|SUPERIORITY||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-0.16|0.19||||||||0.19|-0.16|
73936453|NCT02646423|147403045|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-1.81|1.05||||||||1.05|-1.81|
73936454|NCT02646423|147403046|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-1.96|1.27||||||||1.27|-1.96|
73936455|NCT02646423|147403047|SUPERIORITY||Mean Difference (Net)|0.36|||||TWO_SIDED|95.0|-0.94|1.66||||||||1.66|-0.94|
73936456|NCT02646423|147403048|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.09|0.03||||||||0.03|-0.09|
73936457|NCT02646423|147403049|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.46|1.51||||||||1.51|0.46|
73936458|NCT02646423|147403050|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.64|1.56||||||||1.56|0.64|
73936459|NCT02646423|147403051|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.64|2.81||||||||2.81|0.64|
73936460|NCT02646423|147403052|SUPERIORITY||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.6|6.62||||||||6.62|0.60|
73936461|NCT02646423|147403053|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.72|1.35||||||||1.35|0.72|
73936462|NCT02646423|147403054|SUPERIORITY||Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.86|1.48||||||||1.48|0.86|
73936463|NCT00377819|147403055|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.35%|Mean Difference (Final Values)|0.85|||<|0.0001||95.0|0.44|1.25|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction|||1.25|0.44|<0.0001
73936464|NCT00377819|147403056|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.22%|Mean Difference (Final Values)|1.18|||<|0.0001||95.0|0.63|1.73|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction|||1.73|0.63|<0.0001
73936465|NCT00377819|147403057|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Van Elteren Stratified Rank Test|||||||<0.0001
73936466|NCT00760929|147403097|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4301||90.0|0.58|1.21|||Wald Test|||||1.21|0.58|0.4301
73936467|NCT00760929|147403097|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.0342||90.0|0.42|0.9|||Wald Test|||||0.90|0.42|0.0342
73936468|NCT03073603|147403118|NON_INFERIORITY|We performed a non-inferiority test for the proportions of the drug continuation and drug discontinuation arms experiencing a new MS relapse and/or MRI Brain Lesion over the course of the study duration. The non-inferiority margin used was 8%.|Difference in proportion|0.0753||||0.521|TWO_SIDED|95.0|0.0063|0.15|||Exact binomial test|Exact binomial test for difference in two proportions||We tested the null hypothesis of inferiority with the proportion of disease events (i.e., new MS relapse and/or MRI brain lesion) for the drug discontinuation group being 8% greater than the proportion for the drug continuation group under the alternative that the two rates are equal.||0.1500|0.0063|0.521
73936469|NCT03073603|147403119|SUPERIORITY|||||||0.766|||||||Chi-squared|||||||0.766
73936470|NCT03073603|147403120|SUPERIORITY|||||||0.604|||||||t-test, 2 sided|||||||0.604
73936471|NCT03073603|147403121|SUPERIORITY|||||||0.198|||||||t-test, 2 sided|||||||0.198
73936472|NCT03073603|147403122|SUPERIORITY|||||||0.354|||||||t-test, 2 sided|||||||0.354
73936473|NCT03073603|147403123|SUPERIORITY|||||||0.831|||||||t-test, 2 sided|||||||0.831
73936474|NCT03073603|147403124|SUPERIORITY|||||||0.252|||||||t-test, 2 sided|||||||0.252
73936475|NCT03073603|147403125|SUPERIORITY|||||||0.983|||||||t-test, 2 sided|||||||0.983
73936476|NCT03073603|147403126|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
73936477|NCT03073603|147403127|SUPERIORITY|||||||0.748|||||||t-test, 2 sided|||||||0.748
73936478|NCT03073603|147403128|SUPERIORITY|||||||0.773|||||||t-test, 2 sided|||||||0.773
73936479|NCT03073603|147403129|SUPERIORITY|||||||0.224|||||||t-test, 2 sided|||||||0.224
73936480|NCT03073603|147403130|SUPERIORITY|||||||0.962|||||||t-test, 2 sided|||||||0.962
73936481|NCT03073603|147403131|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
73936482|NCT03073603|147403132|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||||||0.406
73936483|NCT03073603|147403133|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||||||0.348
73936484|NCT03073603|147403134|SUPERIORITY|||||||0.086|||||||t-test, 2 sided|||||||0.086
73936485|NCT03073603|147403135|SUPERIORITY|||||||0.575|||||||t-test, 2 sided|||||||0.575
73936486|NCT03073603|147403136|SUPERIORITY|||||||0.733|||||||Chi-squared|||||||0.733
73936487|NCT03073603|147403137|SUPERIORITY|||||||0.733|||||||Chi-squared|||||||0.733
73936488|NCT03073603|147403138|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
73936489|NCT00304070|147403145|OTHER||2 Year EFS|0.89||||0.44|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 90% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.44
73936490|NCT00304070|147403145|OTHER||2 Year EFS|0.53||||0.4|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 50% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.40
73936491|NCT00304070|147403145|OTHER||2 Year EFS|0.55||||8.53e-06|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 15% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.00000853
73936492|NCT00320216|147403152|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi square test|Stratified by baseline weight \[\<=90kg vs \> 90 kg\].||||||<0.001
73936493|NCT00320216|147403152|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
73936494|NCT00320216|147403152|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
73936495|NCT00320216|147403152|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||To control for the multiplicity for the primary endpoint analysis, the 4 pairwise comparisons between ustekinumab groups and placebo were performed sequentially at alpha = 0.05. The order of testing was prespecified from high to low doses.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis:No difference between any ustekinumab group and placebo at an overall significant level of 0.05. Sample Size: With 300 participants (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in primary endpoint between ustekinumab groups and placebo using a CMH test with stratification by baseline weight \[≤ 90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.01
73936496|NCT00320216|147403153|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
73936497|NCT00320216|147403153|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
73936498|NCT00320216|147403153|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|||||||<0.001
73866407|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85|||||TWO_SIDED|95.0|-5.07|-0.64||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.64|-5.07|
73866408|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.77|||||TWO_SIDED|95.0|-4.98|-0.56||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.56|-4.98|
73866409|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.63|||||TWO_SIDED|95.0|-3.85|0.59||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.59|-3.85|
73866410|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.27|||||TWO_SIDED|95.0|-5.48|-1.06||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.06|-5.48|
73866411|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.23|||||TWO_SIDED|95.0|-4.66|0.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.20|-4.66|
73866412|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|95.0|-6.62|-1.77||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.77|-6.62|
73866413|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.73|||||TWO_SIDED|95.0|-6.15|-1.31||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.31|-6.15|
73936499|NCT00320216|147403153|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between any ustekinumab group and placebo.||||<0.001
73936500|NCT00377676|147403156|NON_INFERIORITY_OR_EQUIVALENCE|In order to test the primary hypothesis at a one-sided alpha = .05 and have a power of 0.9, when the non-inferiority margin is 1.5, the total number of subjects with all-cause SAEs that must be observed during the study was found to be 235. Assuming the placebo rate is 0.08, the required sample size was found to be 2991.|Hazard Ratio (HR)|1.02|||<|0.05|ONE_SIDED|95.0||1.27||Using the Lan and Demets alpha spending function for O'Brien-Fleming boundaries and the overall one-sided significance level of 5%, a level of 0.04068 was to be used at the interim analysis and 0.03938 at the time of the final analysis.|Regression, Cox||cycloset to placebo|||1.27||<0.05
73936501|NCT00377676|147403157|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.58|||<|0.05|TWO_SIDED|95.0|0.35|0.96|||Regression, Cox|||In order to test the hypothesis for serious cardiovascular adverse events as for the primary endpoint at a one-sided alpha = 0.5 when the non-inferiority margin is 1.5, the final sample size of 3000 to 3300 subjects was to provide at least 62% power, assuming a hypothetical rate of events of 3.43%, or 103 to 113 cardiovascular SAEs. Upon demonstration of non-inferiority - a 2 sided using 95% CI was used to assess for superiority.||.96|.35|<0.05
73936502|NCT00377676|147403158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|1.4|<|0.001|||||||ANOVA|||If the standard deviation of HbA1c level is about 1.0% and the baseline and 24 week scores have a correlation of 0.50 then the effect size is 0.5%/1.0% = 0.50. For the metformin/SU analysis, 160 subjects assuming a standard deviation of 1.0% would provide a power of 90% power to detect differences in mean changes of 0.5% or larger.||||<0.001
73936503|NCT00377676|147403159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|||||||ANOVA|||||||<0.001
73936504|NCT00782340|147403165|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||||||0.003
73936505|NCT00782340|147403166|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHDAS composite score as a co-variate.||||||0.003
73936506|NCT00782340|147403167|SUPERIORITY_OR_OTHER|||||||0.01||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.||||||0.010
73973060|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.649|TWO_SIDED|95.0|-3.19|5.11||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.46|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||5.11|-3.19|0.649
73973061|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.389|TWO_SIDED|95.0|-3.22|8.23||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.86|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||8.23|-3.22|0.389
73973062|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|1.55||||0.598|TWO_SIDED|95.0|-4.22|7.31||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.53|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||7.31|-4.22|0.598
73866414|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|||||TWO_SIDED|95.0|-6.09|-1.26||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.26|-6.09|
73866415|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.27|||||TWO_SIDED|95.0|-4.69|0.16||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-4.69|
73866416|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.11|||||TWO_SIDED|95.0|-6.52|-1.7||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.70|-6.52|
73866417|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-5.34|-0.25||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.25|-5.34|
73866418|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.38|||||TWO_SIDED|95.0|-6.93|-1.83||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.83|-6.93|
73866419|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2|||||TWO_SIDED|95.0|-7.74|-2.66||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.66|-7.74|
73866420|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|||||TWO_SIDED|95.0|-7.43|-2.36||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.36|-7.43|
73866421|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.74|||||TWO_SIDED|95.0|-5.28|-0.2||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.20|-5.28|
73866422|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.57|||||TWO_SIDED|95.0|-7.1|-2.05||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.05|-7.10|
73866423|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-0.73|3.33||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.33|-0.73|
73866424|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|||||TWO_SIDED|95.0|-2.18|1.84||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.84|-2.18|
73866425|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|95.0|-1.61|2.44||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.44|-1.61|
73866426|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-2.27|1.73||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.73|-2.27|
73936507|NCT00782340|147403168|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.003
73936508|NCT00782340|147403169|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.||||||0.009
73936509|NCT00782340|147403170|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||<0.001
73936510|NCT00782340|147403171|SUPERIORITY_OR_OTHER|||||||0.327||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the this endpoint was not positive, no additional statistical analyses will be performed on secondary endpoints.|Fisher Exact|||||||0.327
73936511|NCT01944046|147403192|SUPERIORITY|||||||0.503||||||not adjusted primary outcome|Mixed Models Analysis|adjusted for baseline, age category, functionality category||||||0.503
73936512|NCT01944046|147403193|SUPERIORITY|||||||0.61||||||not adjusted primary outcome, p threshold 0.05|Mixed Models Analysis|adjustment for value at week 24,||||||0.61
73866427|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.47|||||TWO_SIDED|95.0|-0.74|3.68||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.68|-0.74|
73866428|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|||||TWO_SIDED|95.0|-1.76|2.65||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.65|-1.76|
73866429|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|-1.79|2.63||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.63|-1.79|
73866430|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-1.69|2.7||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.70|-1.69|
73866431|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.88|||||TWO_SIDED|95.0|-0.53|4.29||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.29|-0.53|
73866432|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-2.5|2.33||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.33|-2.50|
73866433|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-2.03|2.79||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.79|-2.03|
73866434|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-1.97|2.84||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.84|-1.97|
73936513|NCT02504294|147403218|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded since the lower bound of the 95% CI of the difference in percentage was greater than the non-inferiority margin (-12.5%).|Difference in Percentage|-1.3975|||||TWO_SIDED|95.0|-7.6503|4.8553||||||Clustered binomial analysis using logistic regression method was performed and generalized estimating equation method was used to construct 95 percent (%) two-sided confidence intervals (CIs).||4.8553|-7.6503|
73936514|NCT02504294|147403219|SUPERIORITY_OR_OTHER||LS Mean Difference|-1062.0|STANDARD_ERROR_OF_MEAN|803.95||0.1874|TWO_SIDED|95.0|-2643.2|519.2|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA) model with treatment as factor and baseline ESA dose as covariate.||519.2|-2643.2|0.1874
73936515|NCT00167544|147403242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||<|0.05|TWO_SIDED|95.0|-19.49|30.29|||ANCOVA|||The primary analysis of total brain tissue volume was performed using multiple linear regression controlling for postmenstrual age at MRI scan to adjust for differences in timing at MRI. The distributions of potentially important confounding variables at baseline were compared in the two groups using parametric and non-parametric tests as appropriate. All analyses were performed using STATA 11.0. Please see PubMed: 23140612.||30.29|-19.49|<0.05
73936516|NCT02830594|147403264|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.6|||||||Paired t Test|||||||0.60
73936517|NCT02830594|147403265|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.87|||||||Paired t Test|||||||0.87
73936518|NCT02830594|147403266|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.64|||||||Paired t Test|||||||0.64
73936519|NCT01156701|147403288|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-1.42|1.12|||||Direct effect of Zanamivir prophylaxis on influenza risk|||1.12|-1.42|
73936520|NCT01156701|147403288|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-0.93|0.17|||||Total effect of zanamivir prophylaxis|||0.17|-0.93|
73936521|NCT01156701|147403288|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-0.75|0.47|||||Direct effect of zanamivir prophylaxis when index is treated|||0.47|-0.75|
73936522|NCT01156701|147403288|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.23|||||TWO_SIDED|95.0|-1.15|1.62|||||Risk in cohort 1 minus risk in cohort 2|||1.62|-1.15|
73936523|NCT01156701|147403288|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-0.51|0.03|||||Protective effect of zanamivir on susceptible risk|||0.03|-0.51|
73936524|NCT01156701|147403288|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Direct effect of Zanamivir prophylaxis on influenza risk|||1.01|0.99|
73936525|NCT01156701|147403288|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
73936526|NCT01156701|147403288|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.99|
73936527|NCT01156701|147403288|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.02|||||Risk in cohort 1 minus risk in cohort 2|||1.02|0.99|
73973063|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.676|TWO_SIDED|95.0|-3.26|5.02||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.42|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||5.02|-3.26|0.676
73866435|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.78|||||TWO_SIDED|95.0|-0.75|4.3||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.30|-0.75|
73866436|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-2.34|2.73||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.73|-2.34|
73866437|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|95.0|-3.14|1.89||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.89|-3.14|
73866438|NCT01393639|147278685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|||||TWO_SIDED|95.0|-2.84|2.19||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.19|-2.84|
73866439|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-2.91|0.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-2.91|
73866440|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.45|||||TWO_SIDED|95.0|-4.17|-0.73||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.73|-4.17|
73866441|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.03|||||TWO_SIDED|95.0|-3.76|-0.29||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.29|-3.76|
74030577|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.964||||0.3042|TWO_SIDED|95.0|0.542|7.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||7.114|0.542|0.3042
73866442|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.11|||||TWO_SIDED|95.0|-4.82|-1.4||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.40|-4.82|
73866443|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-3.13|0.33||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.33|-3.13|
73866444|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-4.52|-1.07||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.07|-4.52|
73866445|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.67|||||TWO_SIDED|95.0|-3.63|0.29||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.29|-3.63|
73866446|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.98|||||TWO_SIDED|95.0|-3.94|-0.01||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-3.94|
73936528|NCT01156701|147403288|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|0.99|
73936529|NCT01156701|147403289|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-1.17|0.36|||||Direct effect of Zanamivir prophylaxis on asthma risk|||0.36|-1.17|
73936530|NCT01156701|147403289|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-0.8|0.03|||||Total effect of zanamivir prophylaxis|||0.03|-0.80|
73936531|NCT01156701|147403289|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.28|||||TWO_SIDED|95.0|-0.75|0.18|||||Direct effect of zanamivir prophylaxis when index is treated|||0.18|-0.75|
73936532|NCT01156701|147403289|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|95.0|-0.89|0.85|||||Risk in cohort 1 minus risk in cohort 2|||0.85|-0.89|
73936533|NCT01156701|147403289|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.31|0.11|||||Protective effect of zanamivir on susceptible risk|||0.11|-0.31|
73936534|NCT01156701|147403289|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of Zanamivir prophylaxis on asthma risk|||1.00|0.99|
73936535|NCT01156701|147403289|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
73866447|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.07|||||TWO_SIDED|95.0|-4.03|-0.11||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.11|-4.03|
73866448|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.13|||||TWO_SIDED|95.0|-5.09|-1.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.17|-5.09|
73866449|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-3.85|0.09||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.09|-3.85|
73866450|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.84|||||TWO_SIDED|95.0|-4.79|-0.88||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.88|-4.79|
73973064|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|2.48||||0.394|TWO_SIDED|95.0|-3.24|8.19||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.85|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||8.19|-3.24|0.394
73973065|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.585|TWO_SIDED|95.0|-4.15|7.35||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.55|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.35|-4.15|0.585
73973066|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.794|TWO_SIDED|95.0|-3.56|4.65||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.26|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||4.65|-3.56|0.794
73973067|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|2.27||||0.449|TWO_SIDED|95.0|-3.62|8.16||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.76|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||8.16|-3.62|0.449
73973068|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.567|TWO_SIDED|95.0|-4.2|7.64||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.57|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||7.64|-4.20|0.567
73973069|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.794|TWO_SIDED|95.0|-3.56|4.65||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.26|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||4.65|-3.56|0.794
73973070|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.526|TWO_SIDED|95.0|-3.97|7.75||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.64|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.75|-3.97|0.526
73973071|NCT02938923|147488342|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.654|TWO_SIDED|95.0|-4.55|7.23||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.45|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.23|-4.55|0.654
73973072|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.597|TWO_SIDED|95.0|-1.72|2.98||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.53|Difference between the changes (EX+T - EX+P) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||2.98|-1.72|0.597
73973073|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-2.18||||0.184|TWO_SIDED|95.0|-5.41|1.04||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.33|Difference between the changes (EX+T - EUC) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||1.04|-5.41|0.184
73973074|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-2.82||||0.089|TWO_SIDED|95.0|-6.07|0.44||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.71|Difference between the changes (EX+P - EUC) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||0.44|-6.07|0.089
73973075|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.635|TWO_SIDED|95.0|-2.01|3.28||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.47|Difference in the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.28|-2.01|0.635
73973076|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-2.15||||0.242|TWO_SIDED|95.0|-5.76|1.46||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.17|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1.46|-5.76|0.242
73973077|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-2.79||||0.132|TWO_SIDED|95.0|-6.42|0.85||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.51|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||0.85|-6.42|0.132
73866451|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.32|||||TWO_SIDED|95.0|-3.25|0.6||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.60|-3.25|
73866452|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.97|||||TWO_SIDED|95.0|-3.9|-0.04||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.04|-3.90|
73866453|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.43|||||TWO_SIDED|95.0|-4.35|-0.5||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.50|-4.35|
73866454|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.75|||||TWO_SIDED|95.0|-4.66|-0.83||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.83|-4.66|
73866455|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.96|||||TWO_SIDED|95.0|-3.88|-0.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-3.88|
73866456|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.08|||||TWO_SIDED|95.0|-5.0|-1.17||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.17|-5.00|
74030578|NCT01070550|147615294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.726||||0.41|TWO_SIDED|95.0|0.471|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.318|0.471|0.4100
73973078|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.193|TWO_SIDED|95.0|-0.77|3.81||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 1.31|Difference between the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||3.81|-0.77|0.193
73973079|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.39|TWO_SIDED|95.0|-1.86|4.75||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.86|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||4.75|-1.86|0.390
73973080|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.965|TWO_SIDED|95.0|-3.39|3.25||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.04|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||3.25|-3.39|0.965
73866457|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.99|||||TWO_SIDED|95.0|-4.2|0.21||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.21|-4.20|
73866458|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.95|||||TWO_SIDED|95.0|-5.17|-0.72||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.72|-5.17|
73866459|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.44|||||TWO_SIDED|95.0|-5.65|-1.23||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.23|-5.65|
73936536|NCT01156701|147403289|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.99|
73936537|NCT01156701|147403289|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Risk in cohort 1 minus risk in cohort 2|||1.01|0.99|
73936538|NCT01156701|147403289|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
73936539|NCT01156701|147403290|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.46|||||TWO_SIDED|95.0|-0.61|1.54|||||Direct effect of Zanamivir prophylaxis on pneumonia risk|||1.54|-0.61|
73936540|NCT01156701|147403290|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.45|-0.04|||||Total effect of zanamivir prophylaxis|||-0.04|-0.45|
73936541|NCT01156701|147403290|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.39|0.09|||||Direct effect of zanamivir prophylaxis when index is treated|||0.09|-0.39|
73936542|NCT01156701|147403290|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.72|||||TWO_SIDED|95.0|-0.38|1.81|||||Risk in cohort 1 minus risk in cohort 2|||1.81|-0.38|
73936543|NCT01156701|147403290|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.22|0.02|||||Protective effect of zanamivir on susceptible risk|||0.02|-0.22|
73936544|NCT01156701|147403290|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.02|||||Direct effect of Zanamivir prophylaxis on pneumonia risk|||1.02|0.99|
73973081|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.195|TWO_SIDED|95.0|-0.79|3.82||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 1.30|Difference between the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.82|-0.79|0.195
73866460|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.32|||||TWO_SIDED|95.0|-5.52|-1.12||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.12|-5.52|
73866461|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.39|||||TWO_SIDED|95.0|-4.6|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-4.60|
73866462|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.87|||||TWO_SIDED|95.0|-6.07|-1.68||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-6.07|
73866463|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.62|||||TWO_SIDED|95.0|-0.1|3.34||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.34|-0.10|
73866464|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.36|2.05||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.05|-1.36|
73866465|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77|||||TWO_SIDED|95.0|-0.94|2.48||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.48|-0.94|
73866466|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-2.01|1.38||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.38|-2.01|
73866467|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.17|||||TWO_SIDED|95.0|-0.79|3.12||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.12|-0.79|
73866468|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-1.1|2.82||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.82|-1.10|
73866469|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-1.19|2.72||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.72|-1.19|
73936545|NCT01156701|147403290|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Total effect of zanamivir prophylaxis|||1.00|1.00|
73936546|NCT01156701|147403290|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|1.00|
73936547|NCT01156701|147403290|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Risk in cohort 1 minus risk in cohort 2|||1.02|1.00|
73936548|NCT01156701|147403290|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
73936549|NCT01156701|147403291|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.28|||||TWO_SIDED|95.0|-0.83|3.4|||||Direct effect of Zanamivir prophylaxis on bronchitis risk|||3.40|-0.83|
73936550|NCT01156701|147403291|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-0.98|0.47|||||Total effect of zanamivir prophylaxis|||0.47|-0.98|
73936551|NCT01156701|147403291|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.09|||||TWO_SIDED|95.0|-0.85|0.67|||||Direct effect of zanamivir prophylaxis when index is treated|||0.67|-0.85|
73936552|NCT01156701|147403291|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.53|||||TWO_SIDED|95.0|-0.7|3.76|||||Risk in cohort 1 minus risk in cohort 2|||3.76|-0.70|
73936553|NCT01156701|147403291|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.16|||||TWO_SIDED|95.0|-0.44|0.12|||||Protective effect of zanamivir on susceptible risk|||0.12|-0.44|
73936554|NCT01156701|147403291|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||Direct effect of Zanamivir prophylaxis on bronchitis risk|||1.03|0.99|
73936555|NCT01156701|147403291|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
73936556|NCT01156701|147403291|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Direct effect of zanamivir prophylaxis when index is treated|||1.01|0.99|
73936557|NCT01156701|147403291|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.99|1.04|||||Risk in cohort 1 minus risk in cohort 2|||1.04|0.99|
73936558|NCT01156701|147403291|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
73936559|NCT01156701|147403292|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-3.08|2.79|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis|||2.79|-3.08|
73936560|NCT01156701|147403292|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.07|||||TWO_SIDED|95.0|-2.39|0.25|||||Total effect of zanamivir prophylaxis|||0.25|-2.39|
73936561|NCT01156701|147403292|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.08|||||TWO_SIDED|95.0|-2.51|0.35|||||Direct effect of zanamivir prophylaxis when index is treated|||0.35|-2.51|
74039420|NCT04847141|147632416|SUPERIORITY||LS Mean Difference|0.15||||0.2443|TWO_SIDED|95.0|-0.11|0.41||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.41|-0.11|0.2443
73936562|NCT01156701|147403292|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.93|||||TWO_SIDED|95.0|-2.29|4.14|||||Risk in cohort 1 minus risk in cohort 2|||4.14|-2.29|
73936563|NCT01156701|147403292|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.58|0.59|||||Protective effect of zanamivir on susceptible risk|||0.59|-0.58|
73936564|NCT01156701|147403292|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.03|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis|||1.03|0.97|
73936565|NCT01156701|147403292|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.98|
73936566|NCT01156701|147403292|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.98|
73936567|NCT01156701|147403292|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.98|1.04|||||Risk in cohort 1 minus risk in cohort 2|||1.04|0.98|
73936568|NCT01156701|147403292|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|0.99|
73936569|NCT01764945|147403317|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.58|STANDARD_DEVIATION|19.7|||TWO_SIDED|90.0|73.69|92.54|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||92.54|73.69|
73936570|NCT01764945|147403317|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.34|STANDARD_DEVIATION|22.2|||TWO_SIDED|90.0|73.65|94.3|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||94.30|73.65|
73936571|NCT01764945|147403317|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.92|STANDARD_DEVIATION|19.6|||TWO_SIDED|90.0|74.69|94.28|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||94.28|74.69|
73936572|NCT01764945|147403317|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.9|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|88.94|97.04|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||97.04|88.94|
73936573|NCT01764945|147403317|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|96.37|STANDARD_DEVIATION|12.7|||TWO_SIDED|90.0|91.55|101.43|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||101.43|91.55|
73936574|NCT01764945|147403317|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.44|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|89.88|99.24|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||99.24|89.88|
73936575|NCT01764945|147403318|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|74.07|STANDARD_DEVIATION|21.5|||TWO_SIDED|90.0|65.44|83.83|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||83.83|65.44|
73936576|NCT01764945|147403318|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|73.23|STANDARD_DEVIATION|26.2|||TWO_SIDED|90.0|63.33|84.68|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||84.68|63.33|
73936577|NCT01764945|147403318|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.76|STANDARD_DEVIATION|22.7|||TWO_SIDED|90.0|68.94|89.99|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||89.99|68.94|
73866470|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-2.24|1.66||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.66|-2.24|
73866471|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.76|||||TWO_SIDED|95.0|-0.16|3.67||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.67|-0.16|
74030579|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.379|||<|0.0001|TWO_SIDED|95.0|1.236|1.538|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.538|1.236|<0.0001
74030580|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.033||||0.0251|TWO_SIDED|95.0|1.004|1.063|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|1.004|0.0251
74030581|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.585|||<|0.0001|TWO_SIDED|95.0|1.358|1.849|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.849|1.358|<0.0001
74030582|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.501||||0.0317|TWO_SIDED|95.0|1.036|2.174|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.174|1.036|0.0317
74030583|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.493||||0.0129|TWO_SIDED|95.0|1.089|2.048|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.048|1.089|0.0129
74030584|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.616||||0.0128|TWO_SIDED|95.0|1.107|2.357|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\^9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.357|1.107|0.0128
74030585|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.046||||0.7809|TWO_SIDED|95.0|0.763|1.432|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\^9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.432|0.763|0.7809
74030586|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969|||<|0.0001|TWO_SIDED|95.0|0.962|0.976|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.976|0.962|<0.0001
73866472|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.12|||||TWO_SIDED|95.0|-0.81|3.04||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.04|-0.81|
73866473|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-1.26|2.57||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.57|-1.26|
73866474|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.57|2.25||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.25|-1.57|
73866475|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.88|||||TWO_SIDED|95.0|-0.31|4.07||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.07|-0.31|
73866476|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|||||TWO_SIDED|95.0|-1.28|3.13||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.13|-1.28|
73866477|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-1.76|2.62||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.62|-1.76|
73866478|NCT01393639|147278687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-1.63|2.74||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.74|-1.63|
73866479|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.49|||||TWO_SIDED|95.0|-12.52|3.55||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.55|-12.52|
73866480|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.15|||||TWO_SIDED|95.0|-18.1|-2.2||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.20|-18.10|
73866481|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.93|||||TWO_SIDED|95.0|-18.94|-2.92||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.92|-18.94|
74030587|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.298||||0.0189|TWO_SIDED|95.0|1.273|14.512|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||14.512|1.273|0.0189
74030588|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.0316|TWO_SIDED|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.359|1.040|0.0316
74030589|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.495||||0.0024|TWO_SIDED|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.879|1.701|0.0024
74030590|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112||||0.0247|TWO_SIDED|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.219|1.014|0.0247
74030591|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.0258|TWO_SIDED|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.077|0.0258
73866482|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.12|||||TWO_SIDED|95.0|-24.01|-8.24||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.24|-24.01|
73936578|NCT01764945|147403318|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.3|STANDARD_DEVIATION|22.5|||TWO_SIDED|90.0|71.42|85.84|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||85.84|71.42|
73866483|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.45|||||TWO_SIDED|95.0|-13.45|2.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.56|-13.45|
73866484|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-22.09|-6.11||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.11|-22.09|
73866485|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.42|||||TWO_SIDED|95.0|-11.13|4.29||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.29|-11.13|
73866486|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.98|||||TWO_SIDED|95.0|-15.7|-0.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.26|-15.70|
73866487|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.17|||||TWO_SIDED|95.0|-12.93|2.59||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.59|-12.93|
73866488|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.22|||||TWO_SIDED|95.0|-17.9|-2.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.54|-17.90|
73936579|NCT01764945|147403318|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.43|STANDARD_DEVIATION|30.4|||TWO_SIDED|90.0|69.54|88.46|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||88.46|69.54|
73936580|NCT01764945|147403318|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.09|STANDARD_DEVIATION|29.4|||TWO_SIDED|90.0|69.35|87.94|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||87.94|69.35|
73936581|NCT01764945|147403319|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.02|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|75.98|88.55|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||88.55|75.98|
73936582|NCT01764945|147403319|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|80.93|STANDARD_DEVIATION|14.5|||TWO_SIDED|90.0|74.58|87.83|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||87.83|74.58|
73973082|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.418|TWO_SIDED|95.0|-1.93|4.63||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.81|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||4.63|-1.93|0.418
73936583|NCT01764945|147403319|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|79.6|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|74.84|84.67|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||84.67|74.84|
73936584|NCT01764945|147403319|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|91.59|STANDARD_DEVIATION|11.0|||TWO_SIDED|90.0|87.53|95.84|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||95.84|87.53|
73936585|NCT01764945|147403319|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.38|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|89.76|99.24|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||99.24|89.76|
73936586|NCT01764945|147403319|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.91|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|88.42|97.63|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||97.63|88.42|
73866489|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.43|||||TWO_SIDED|95.0|-5.32|10.19||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.19|-5.32|
74088882|NCT01523587|147730958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.814||||0.0103|TWO_SIDED|95.0|0.693|0.956||P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional hazards model without the randomization stratification variable was used for each subgroup category, along with the corresponding log-rank test.||0.956|0.693|0.0103
73866490|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.14|||||TWO_SIDED|95.0|-18.83|-3.45||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.45|-18.83|
73866491|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.42|||||TWO_SIDED|95.0|-12.44|1.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.59|-12.44|
73866492|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.24|||||TWO_SIDED|95.0|-19.27|-5.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.20|-19.27|
74088883|NCT01523587|147730959|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841||||0.0193|TWO_SIDED|95.0|0.727|0.973||P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional-hazards model, stratified by race, was used to estimate the hazard ratio and 95% confidence interval (CI) between the two treatment groups.||0.973|0.727|0.0193
74088884|NCT01523587|147730960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.0551|TWO_SIDED|95.0|0.98|4.32||Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.|Regression, Logistic|||||4.32|0.98|0.0551
74088885|NCT01523587|147730961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.002|TWO_SIDED|95.0|1.18|2.06|||Regression, Logistic|Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.||||2.06|1.18|0.0020
74088886|NCT01523587|147730962|SUPERIORITY_OR_OTHER||Adjusted mean|-1.2|STANDARD_ERROR_OF_MEAN|1.77||0.5|TWO_SIDED|95.0|-4.67|2.28|||ANCOVA||Mean was adjusted for baseline sum of diameters and race.|The analysis will compare the treatments using analysis of covariance (ANCOVA) for minimum sum of diameters, using baseline sum of diameters as a covariate. The randomization strata will be included as classification factors.||2.28|-4.67|0.500
74088887|NCT01523587|147730964|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2562|TWO_SIDED|95.0|0.72|1.09||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Coughing.||1.09|0.72|0.2562
73957851|NCT02715258|147451251|SUPERIORITY||mixed-effects repeated measures|-0.79||||0.1222|TWO_SIDED|95.0|-1.8|0.21||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in body weight (kg) at Week 24 for subjects with BMI greater than or equal to 25 kg/m2||0.21|-1.80|0.1222
73957852|NCT02715258|147451251|SUPERIORITY||mixed-effects repeated measures|-0.65||||0.2014|TWO_SIDED|95.0|-1.65|0.35||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication||0.35|-1.65|0.2014
73957853|NCT02715258|147451251|SUPERIORITY||mixed-effects repeated measures|-0.91||||0.0638|TWO_SIDED|95.0|-1.88|0.05||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 2: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 excluding observations obtained after rescue medication||0.05|-1.88|0.0638
74088888|NCT01523587|147730964|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0078|TWO_SIDED|95.0|0.66|0.94||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Dyspnoea||0.94|0.66|0.0078
73957854|NCT02715258|147451251|SUPERIORITY||mixed-effects repeated measures|-0.69||||0.1456|TWO_SIDED|95.0|-1.63|0.24||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 3: LOCF for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication||0.24|-1.63|0.1456
73957855|NCT02715258|147451252|SUPERIORITY||mixed-effects repeated measures|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.92|-1.09||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in FPG (mmol/L) over time across 24 weeks||-1.09|-1.92|<0.0001
73957856|NCT02715258|147451253|SUPERIORITY||mixed-effects repeated measures|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.79|-0.43||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 6||-0.43|-0.79|<0.0001
73957857|NCT02715258|147451253|SUPERIORITY||mixed-effects repeated measures|-0.71|||<|0.0001|TWO_SIDED|95.0|-0.92|-0.5||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 12||-0.50|-0.92|<0.0001
73866493|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.13|||||TWO_SIDED|95.0|-16.11|-2.14||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.14|-16.11|
73866494|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.88|||||TWO_SIDED|95.0|-16.89|-2.88||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.88|-16.89|
73866495|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.61|||||TWO_SIDED|95.0|-9.63|4.4||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.40|-9.63|
73866496|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.93|||||TWO_SIDED|95.0|-19.88|-5.98||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.98|-19.88|
73866497|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-10.03|3.83||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.83|-10.03|
73866498|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-17.06|-3.13||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.13|-17.06|
73866499|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.67|||||TWO_SIDED|95.0|-17.57|-3.77||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.77|-17.57|
73866500|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.79|||||TWO_SIDED|95.0|-14.72|-0.86||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.86|-14.72|
73866501|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.05|||||TWO_SIDED|95.0|-9.98|3.89||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.89|-9.98|
73866502|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.41|||||TWO_SIDED|95.0|-20.27|-6.54||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.54|-20.27|
73866503|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.61|||||TWO_SIDED|95.0|1.62|17.61||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.61|1.62|
73866504|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.95|||||TWO_SIDED|95.0|-3.96|11.85||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.85|-3.96|
73936587|NCT02911948|147403328|SUPERIORITY|Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was strictly below 0.0% for null hypothesis (H0): D=0.0% against the alternative (HA): D≠0.0%, where D is the mean difference (IDegLira - IDeg).|Treatment contrast|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.06|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an ANCOVA model with treatment and pre-trial anti-diabetic treatment as fixed factors and corresponding baseline HbA1c value as covariate.||-1.06|-1.50|<0.0001
73936588|NCT03819660|147403368|OTHER||percentage|38.5|||||TWO_SIDED|||||||||||||
73936589|NCT02308033|147403370|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
73936590|NCT02308033|147403371|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
73936591|NCT02308033|147403372|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of normal Nugent scores at 7-14 days||||<0.001
73936592|NCT02308033|147403373|SUPERIORITY|||||||0.034|||||||Chi-squared, Corrected|||Comparison of the number of subjects whose reported their symptoms completely resolved||||0.034
73936593|NCT00809757|147403375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||||TWO_SIDED|95.0|-1.412|0.342|||||Difference is Placebo MDI minus Levalbuterol UDV|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.||0.342|-1.412|
73936594|NCT00809757|147403375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-1.714|0.335|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations||0.335|-1.714|
73936595|NCT00809757|147403375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-1.08|0.771|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.||0.771|-1.080|
73936596|NCT01410448|147403406|SUPERIORITY_OR_OTHER|||||||0.0921|||||||Regression, Logistic|||||||0.0921
73866505|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.17|||||TWO_SIDED|95.0|-4.8|11.13||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.13|-4.80|
73866506|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.03|||||TWO_SIDED|95.0|-9.86|5.81||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.81|-9.86|
73866507|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.72|||||TWO_SIDED|95.0|0.03|15.42||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.42|0.03|
73866508|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.16|||||TWO_SIDED|95.0|-4.54|10.87||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.87|-4.54|
73866509|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.97|||||TWO_SIDED|95.0|-1.77|13.71||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.71|-1.77|
73866510|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|-6.75|8.59||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.59|-6.75|
73866511|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|0.57|14.43||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.43|0.57|
73866512|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69|||||TWO_SIDED|95.0|-6.26|7.64||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.64|-6.26|
73866513|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-3.09|10.7||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.70|-3.09|
73866514|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.05|||||TWO_SIDED|95.0|-3.87|9.96||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.96|-3.87|
73866515|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.31|||||TWO_SIDED|95.0|3.43|17.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.18|3.43|
73866516|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.31|||||TWO_SIDED|95.0|-3.59|10.22||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.22|-3.59|
73936597|NCT00360529|147403423|SUPERIORITY_OR_OTHER|||||||0.0454||95.0||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 50 mg qhs versus placebo||||0.0454
73936598|NCT00360529|147403423|SUPERIORITY_OR_OTHER|||||||0.0024||95.0||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 100 mg qhs versus placebo||||0.0024
73936599|NCT00360529|147403424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2606||95.0|-1.0|3.7||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||3.7|-1.0|0.2606
73936600|NCT00360529|147403424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.066||95.0|-0.1|4.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||4.6|-0.1|0.066
73936601|NCT00360529|147403425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.1601||95.0|-2.9|0.5||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.5|-2.9|0.1601
74030592|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.677||||0.0007|TWO_SIDED|95.0|1.243|2.263|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.263|1.243|0.0007
74030593|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.384||||0.0002|TWO_SIDED|95.0|1.166|1.641|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.641|1.166|0.0002
74030594|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.0002|TWO_SIDED|95.0|1.421|3.074|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.074|1.421|0.0002
74030595|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.288||||0.0006|TWO_SIDED|95.0|0.141|0.588|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.588|0.141|0.0006
74030596|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.247||||0.0013|TWO_SIDED|95.0|0.106|0.579|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.579|0.106|0.0013
74030597|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.959||||0.0062|TWO_SIDED|95.0|0.931|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.931|0.0062
74030598|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.708||||0.002|TWO_SIDED|95.0|0.568|0.881|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.881|0.568|0.0020
74030599|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.434|||<|0.0001|TWO_SIDED|95.0|1.288|1.596|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.596|1.288|<0.0001
74030600|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.475|||<|0.0001|TWO_SIDED|95.0|1.26|1.726|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.726|1.260|<0.0001
73866517|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.73|||||TWO_SIDED|95.0|-4.1|9.57||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.57|-4.10|
73866518|NCT01393639|147278689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.62|||||TWO_SIDED|95.0|-1.25|12.48||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.48|-1.25|
73866519|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-7.56|8.31||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.31|-7.56|
73866520|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.15|||||TWO_SIDED|95.0|-16.01|-0.3||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.30|-16.01|
73866521|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-22.01|-6.2||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.20|-22.01|
73866522|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.88|||||TWO_SIDED|95.0|-19.7|-4.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.06|-19.70|
73866523|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-7.33|8.48||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.48|-7.33|
73866524|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.89|||||TWO_SIDED|95.0|-20.8|-4.98||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.98|-20.80|
73866525|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-9.31|8.58||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.58|-9.31|
73866526|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.48|||||TWO_SIDED|95.0|-18.43|-0.53||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.53|-18.43|
73866527|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.42|||||TWO_SIDED|95.0|-22.39|-4.44||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.44|-22.39|
73866528|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.58|||||TWO_SIDED|95.0|-17.48|0.33||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.33|-17.48|
74030601|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.963|||<|0.0001|TWO_SIDED|95.0|0.956|0.97|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.956|<0.0001
73936602|NCT00360529|147403425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.0001||95.0|-5.6|-2.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||-2.2|-5.6|0.0001
73866529|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-11.57|6.38||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.38|-11.57|
73866530|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.75|||||TWO_SIDED|95.0|-22.73|-4.78||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.78|-22.73|
73866531|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-9.32|8.88||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.88|-9.32|
73866532|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.28|||||TWO_SIDED|95.0|-21.39|-3.17||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.17|-21.39|
73866533|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.44|||||TWO_SIDED|95.0|-25.53|-7.36||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.36|-25.53|
73866534|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.38|||||TWO_SIDED|95.0|-18.42|-0.34||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.34|-18.42|
73866535|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.52|||||TWO_SIDED|95.0|-13.61|4.57||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.57|-13.61|
73866536|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.78|||||TWO_SIDED|95.0|-22.87|-4.69||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.69|-22.87|
73866537|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.85|||||TWO_SIDED|95.0|-7.9|11.6||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.60|-7.90|
73866538|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|||||TWO_SIDED|95.0|-20.51|-0.93||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.93|-20.51|
73866539|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-28.28|-8.77||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.77|-28.28|
73866540|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.96|||||TWO_SIDED|95.0|-22.67|-3.25||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.25|-22.67|
73866541|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.46|||||TWO_SIDED|95.0|-17.21|2.3||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.30|-17.21|
73973083|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.921|TWO_SIDED|95.0|-3.46|3.13||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.10|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.13|-3.46|0.921
73973084|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.078|TWO_SIDED|95.0|-0.26|4.88||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.77|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||4.88|-0.26|0.078
73973085|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.982|TWO_SIDED|95.0|-3.51|3.43||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.02|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||3.43|-3.51|0.982
73973086|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-2.35||||0.187|TWO_SIDED|95.0|-5.85|1.15||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.32|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||1.15|-5.85|0.187
73866542|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.24|||||TWO_SIDED|95.0|-26.0|-6.48||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.48|-26.00|
73866543|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.27|||||TWO_SIDED|95.0|5.34|21.2||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||21.20|5.34|
73866544|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.74|||||TWO_SIDED|95.0|-3.12|12.59||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.59|-3.12|
73866545|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-9.1|6.68||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.68|-9.10|
73866546|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.01|||||TWO_SIDED|95.0|-6.79|8.81||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.81|-6.79|
73866547|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.39|||||TWO_SIDED|95.0|4.39|22.38||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.38|4.39|
73866548|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.27|||||TWO_SIDED|95.0|-4.73|13.27||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.27|-4.73|
73866549|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-8.68|9.35||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.35|-8.68|
73866550|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.18|||||TWO_SIDED|95.0|-3.77|14.12||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.12|-3.77|
73866551|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.56|||||TWO_SIDED|95.0|4.44|22.68||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.68|4.44|
73866552|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-7.64|10.64||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.64|-7.64|
73866553|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.66|||||TWO_SIDED|95.0|-11.76|6.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.44|-11.76|
73866554|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.41|||||TWO_SIDED|95.0|-4.65|13.46||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.46|-4.65|
73866555|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.09|||||TWO_SIDED|95.0|8.34|27.84||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||27.84|8.34|
73866556|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.52|||||TWO_SIDED|95.0|-4.27|15.32||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.32|-4.27|
73866557|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.28|||||TWO_SIDED|95.0|-12.03|7.46||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.46|-12.03|
73866558|NCT01393639|147278691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.28|||||TWO_SIDED|95.0|-6.42|12.98||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.98|-6.42|
73866559|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.06|||||TWO_SIDED|95.0|-14.07|-0.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.06|-14.07|
73973087|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|2.16||||0.08|TWO_SIDED|95.0|-0.26|4.58||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.76|Difference of the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||4.58|-0.26|0.080
73866560|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.45|||||TWO_SIDED|95.0|-19.34|-5.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.56|-19.34|
73866561|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.85|||||TWO_SIDED|95.0|-19.79|-5.91||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.91|-19.79|
73936603|NCT00360529|147403426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1144||95.0|-0.3|0.0||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.0|-0.3|0.1144
73936604|NCT00360529|147403426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0001||95.0|-0.5|-0.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||-0.2|-0.5|0.0001
73936605|NCT00360529|147403427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.0173||95.0|0.0|0.4|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.4|0.0|0.0173
73936606|NCT00360529|147403427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0001||95.0|0.2|0.5|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||0.5|0.2|0.0001
73936607|NCT00360529|147403428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.0071||95.0|0.4|2.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||2.6|0.4|0.0071
73936608|NCT00360529|147403428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.0001||95.0|1.4|3.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||3.6|1.4|0.0001
73973088|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.781|TWO_SIDED|95.0|-3.76|2.83||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.28|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||2.83|-3.76|0.781
73973089|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-2.63||||0.121|TWO_SIDED|95.0|-5.94|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.56|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||0.69|-5.94|0.121
73973090|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|1.58||||0.148|TWO_SIDED|95.0|-0.57|3.73||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.45|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||3.73|-0.57|0.148
73936609|NCT00360529|147403429|SUPERIORITY_OR_OTHER||Percentage responders|34.7||||0.0513||95.0|29.0|40.4|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 25 mg bid versus placebo||40.4|29.0|0.0513
73936610|NCT00360529|147403429|SUPERIORITY_OR_OTHER||Percentage responders|38.6||||0.0059||95.0|32.6|44.6|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 50 mg qhs versus placebo||44.6|32.6|0.0059
73936611|NCT01218438|147403432|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.012|||<|0.0001|ONE_SIDED|99.0||0.024|||Poisson|||||0.024||<0.0001
73936612|NCT02091167|147403515|OTHER|||||||0.05|||||||ANOVA|||We powered for a medium effect size based on our previous study with effect size (partial ղ2) of 0.10384 for the main within-subject factor in the two-way ANOVA with repeated measures. With a power of 80%, and a two-sided probability of a type I error of 5%, the resulting minimum sample size was 30 participants. To account for waiving or dropouts we increased the estimated sample size to approximately 10%, resulting in 33 subjects in total (approximately 16 to 17 subjects in each group).|"Most of data (age, patterns of crack-cocaine use, 5-items OCCS) were normally distributed according to the D'Agostino \& Pearson normality test, thus they were analyzed by parametric tests. Between-group (sham- and real tDCS) comparisons were conducted by unpaired Student´s t-tests. For all other non-parametric data (gender, schooling, employment, marital state and tobacco use), Chi-square or Fisher tests were used to compare sham and real tDCS groups.~Besides the two-way ANOVA with repeated measures followed by Bonferroni-corrected t-tests, linear regression analyses were done over craving scores obtained along the 4-week treatment (five time-points measurements) for both groups. Additional comparisons between initial and final OCDS scores were done by paired t-tests for each group, and differences between final and initial scores were compared between sham-tDCS and real tDCS groups with unpaired t-test."|||0.05
73936613|NCT02091167|147403516|OTHER|||||||0.05|||||||Fisher Exact|||Two patients from each group were lost to follow-up after their discharge from the hospital.||||0.05
73973091|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.699|TWO_SIDED|95.0|-3.64|2.45||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.39|Differences between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||2.45|-3.64|0.699
73936614|NCT00932893|147403536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.487|||<|0.0001||95.0|0.371|0.638||To control family-wise Type 1 error, a step-down procedure was applied in following order: PFS, objective response rate (ORR), overall survival (OS), and disease control rate (DCR). Statistical significance: 1-sided at alpha=0.025.|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by Eastern Cooperative Oncology Group performance status (ECOG PS) score, brain metastases, and prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment. The hazard ratio and corresponding 95% confidence interval (CI) from the stratified Cox Proportional Hazards model were also presented.||0.638|0.371|<0.0001
73936615|NCT00932893|147403537|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854||||0.1145||95.0|0.661|1.104||Statistical significance: 1-sided at alpha=0.025|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by ECOG PS score, brain metastases, and prior EGFR TKI treatment. The hazard ratio and corresponding 95% CI from the stratified Cox proportional hazards model were also presented.||1.104|0.661|0.1145
73866562|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.92|||||TWO_SIDED|95.0|-22.79|-9.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-9.06|-22.79|
73866563|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.95|||||TWO_SIDED|95.0|-10.89|2.99||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.99|-10.89|
73866564|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.51|||||TWO_SIDED|95.0|-20.44|-6.57||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.57|-20.44|
73866565|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.25|||||TWO_SIDED|95.0|-14.65|0.16||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-14.65|
73866566|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.03|||||TWO_SIDED|95.0|-19.38|-4.68||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.68|-19.38|
73936616|NCT00932893|147403539|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.394|||<|0.0001||95.0|2.463|4.676||Statistical significance: 2-sided at alpha=0.025.|Cochran-Mantel-Haenszel|||P-value was obtained from Cochran-Mantel-Haenszel (CMH) test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||4.676|2.463|<0.0001
73866567|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.72|||||TWO_SIDED|95.0|-23.1|-8.35||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.35|-23.10|
73936617|NCT00932893|147403540|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.502|||<|0.0001||95.0|1.297|1.741||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||1.741|1.297|<0.0001
73936618|NCT00932893|147403541|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.697|||<|0.0001|TWO_SIDED|95.0|1.368|2.103||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||2.103|1.368|<0.0001
73936619|NCT00932893|147403547|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.497|||<|0.0001||95.0|0.373|0.661|||Log Rank|||The p-value was obtained from 2-sided unstratified log-rank test. The hazard ratio and corresponding 95% CI from the Cox Proportional Hazards model were also presented.||0.661|0.373|<0.0001
73936620|NCT00746954|147403554|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANOVA|||Comparisons among groups||||0.45
73936621|NCT01763567|147403569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|STANDARD_DEVIATION|9.5|||TWO_SIDED|||||||||||||
73936622|NCT01763567|147403570|SUPERIORITY_OR_OTHER||percent of events correctly detected|16.7|||||TWO_SIDED|||||||||||||
73936623|NCT01763567|147403571|SUPERIORITY_OR_OTHER||percent of events correctly detected|88.9|||||TWO_SIDED|||||||||||||
73936624|NCT01763567|147403572|SUPERIORITY_OR_OTHER||% of false alert|85.8|||||TWO_SIDED|||||||||||||
73936625|NCT01763567|147403573|SUPERIORITY_OR_OTHER||% of false alert|56.5|||||TWO_SIDED|||||||||||||
73936626|NCT00566228|147403604|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.69|TWO_SIDED|95.0|0.62|2.08|||Log Rank|||||2.08|0.62|0.690
73936627|NCT00566228|147403607|SUPERIORITY|||||||0.679|||||||Log Rank|||||||0.679
73936628|NCT01928719|147403629|OTHER||Hazard Ratio (HR)|3.3|||<|0.0001|TWO_SIDED|95.0|1.95|5.58|||Regression, Cox||The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||5.58|1.95|<0.0001
73936629|NCT01928719|147403630|OTHER||Hazard Ratio (HR)|3.4|||<|0.0001|TWO_SIDED|95.0|1.99|5.81||Testing the effect of treatment group in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Age Group, Working Status, and BMI.|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|The reference group is Same Nicotine Content Group.||5.81|1.99|<0.0001
74039421|NCT04847141|147632416|SUPERIORITY||LS Mean Difference|0.13||||0.3233|TWO_SIDED|95.0|-0.13|0.39||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.39|-0.13|0.3233
73866568|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.95|||||TWO_SIDED|95.0|-21.27|-6.63||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.63|-21.27|
73936630|NCT01928719|147403630|OTHER||Hazard Ratio (HR)|0.51||||0.06|TWO_SIDED|95.0|0.26|1.03||Testing the effect of age group (ages 30-39) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 30-39 to the Age group 18-29.|The reference group is Age equals 18-29.||1.03|0.26|0.06
73936631|NCT01928719|147403630|OTHER||Hazard Ratio (HR)|0.33|||<|0.002|TWO_SIDED|95.0|0.17|0.66||Testing the effect of age group (ages 40-49) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 40-49 to the Age group 18-29.|The reference group is Age equals 18-29.||0.66|0.17|<0.002
73866569|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.94|||||TWO_SIDED|95.0|-13.31|1.43||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.43|-13.31|
73936632|NCT01928719|147403630|OTHER||Hazard Ratio (HR)|0.33|||<|0.002|TWO_SIDED|95.0|0.16|0.65||Testing the effect of age group (Ages 50-59) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 50-59 to Age group 18-29.|The reference group is Age equals 18-29.||0.65|0.16|<0.002
73936633|NCT01928719|147403630|OTHER||Hazard Ratio (HR)|0.39||||0.1|TWO_SIDED|95.0|0.13|1.18||Testing the effect of age group (Ages 60-65) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 60-65 to the Age group 18-29.|The reference group is Age equals 18-29.||1.18|0.13|0.1
73936634|NCT01928719|147403630|OTHER||Hazard Ratio (HR)|1.6||||0.1|TWO_SIDED|95.0|0.92|2.66||Testing the effect of working status in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Age, and BMI.||The reference group is not currently working.|The direction of comparison is currently working to not currently working.|2.66|0.92|0.1
73936635|NCT01928719|147403630|OTHER||Hazard Ratio (HR)|0.25||||0.006|TWO_SIDED|95.0|0.1|0.67||Testing the effect of BMI Normal Weight group (\>=18.5 \& \<25) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Normal Weight (\>=18.5 \& \<25) to Underweight (\<18.5) group.|The reference group is BMI Underweight (\<18.5)||0.67|0.1|0.006
73936636|NCT01928719|147403630|OTHER||Hazard Ratio (HR)|0.35||||0.034|TWO_SIDED|95.0|0.13|0.92||Testing the effect of BMI Overweight group (\>=25 \& \< 30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Overweight (\>=25 \& \< 30) to Underweight (\<18.5) group.|The reference group is BMI Underweight group (\<18.5)||0.92|0.13|0.034
73936637|NCT01928719|147403630|OTHER||Hazard Ratio (HR)|0.31||||0.011|TWO_SIDED|95.0|0.13|0.77||Testing the effect of BMI Obese group (\>=30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Obese (\>=30) to Underweight (\<18.5) group.|The reference group is BMI Underweight group (\<18.5)||0.77|0.13|0.011
73936638|NCT01928719|147403631|OTHER||Least Squares Mean Difference|-4.1||||0.0006|TWO_SIDED|95.0|-6.44|-1.75|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-1.75|-6.44|0.0006
73936639|NCT01928719|147403632|OTHER||Least Squares Mean Difference|-136.7|||<|0.0001|TWO_SIDED|95.0|-171.7|-101.7|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-101.7|-171.7|<.0001
73936640|NCT01928719|147403633|OTHER||Least Squares Mean Difference|-4.03||||0.0305|TWO_SIDED|95.0|-7.68|-0.38|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-0.38|-7.68|0.0305
73936641|NCT01928719|147403634|OTHER||Least Squares Mean Difference|1.81||||0.0207|TWO_SIDED|95.0|0.28|3.33|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||3.33|0.28|0.0207
73936642|NCT01928719|147403635|OTHER||Least Squares Mean Difference|-0.16||||0.4191|TWO_SIDED|95.0|-0.56|0.23|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||0.23|-0.56|0.4191
73936643|NCT00414700|147403636|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion||Test for superiority||||0.003
73936644|NCT00414700|147403637|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion.||Test for superiority||||0.010
73936645|NCT00414700|147403638|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -9 % points|Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-3.28|6.9|||ANCOVA|Adjusted for baseline Overall KOOS score, age, associated lesion(s) and location of lesion.||||6.90|-3.28|
73936646|NCT02896855|147403829|OTHER||Stratified Hazard Ratio|0.69||||0.0418|TWO_SIDED|95.0|0.49|0.99|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|This was for the primary analysis. Hypothesis testing is considered exploratory in this bridging study.||0.99|0.49|0.0418
73936647|NCT02896855|147403829|OTHER||Unstratified Hazard Ratio|0.71||||0.0556|TWO_SIDED|95.0|0.5|1.01|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|This was for the primary analysis. Hypothesis testing is considered exploratory in this bridging study.||1.01|0.50|0.0556
73936648|NCT02896855|147403829|OTHER||Stratified Hazard Ratio|0.6||||0.0008|TWO_SIDED|95.0|0.45|0.81|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|This was for the final analysis. Hypothesis testing is considered exploratory in this bridging study.||0.81|0.45|0.0008
73936649|NCT02896855|147403829|OTHER||Unstratified Hazard Ratio|0.63||||0.0019|TWO_SIDED|95.0|0.47|0.85|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|This was for the final analysis. Hypothesis testing is considered exploratory in this bridging study.||0.85|0.47|0.0019
73936650|NCT02896855|147403831|OTHER||Stratified Hazard Ratio|0.68||||0.0658|TWO_SIDED|95.0|0.45|1.03|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.03|0.45|0.0658
73936651|NCT02896855|147403831|OTHER||Unstratified Hazard Ratio|0.7||||0.0864|TWO_SIDED|95.0|0.46|1.06|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.06|0.46|0.0864
73936652|NCT02896855|147403833|OTHER||Difference in Objective Response|9.98||||0.1126|TWO_SIDED|95.0|-2.65|22.6|||Cochran-Mantel-Haenszel|Statistical test is stratified by disease type and hormone receptor status.|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.||22.60|-2.65|0.1126
73936653|NCT02896855|147403833|OTHER||Difference in Objective Response|9.98||||0.1108|TWO_SIDED|95.0|-2.65|22.6|||Fisher Exact|Unadjusted|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.||22.60|-2.65|0.1108
73936654|NCT02896855|147403834|OTHER||Cox Proportional Hazard|0.78||||0.2867|TWO_SIDED|95.0|0.49|1.24|||Log Rank|Two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.24|0.49|0.2867
73936655|NCT02896855|147403841|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.96|0.75|||||The treatment difference for change from baseline to maximum on-treatment decrease in LVEF is defined as Arm B: Pertuzumab minus Arm A: Placebo.|||0.75|-1.96|
73973092|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-2.18||||0.163|TWO_SIDED|95.0|-5.24|0.89||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.4|Difference in the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||0.89|-5.24|0.163
74088889|NCT01523587|147730964|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.869|TWO_SIDED|95.0|0.82|1.18||p-value calculated using log rank test stratified by race|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Pain||1.18|0.82|0.8690
74088890|NCT01523587|147730965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.34||0.0091|TWO_SIDED|95.0|-6.15|-0.88|||Regression, Cox|||The results shown relate to Change in scores over time for: Coughing.||-0.88|-6.15|0.0091
74088891|NCT01523587|147730965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.15||0.0024|TWO_SIDED|95.0|-5.75|-1.25|||Regression, Cox|||The results shown relate to Change in scores over time for: Dyspnoea.||-1.25|-5.75|0.0024
74088892|NCT01523587|147730965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.32||0.0384|TWO_SIDED|95.0|-5.33|-0.15|||Regression, Cox|||The results shown relate to Change in scores over time for: Pain.||-0.15|-5.33|0.0384
74088893|NCT01298778|147730966|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||acute pain scores with movement at 24 hours||||0.05
74088894|NCT04070287|147730974|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
74088895|NCT04070287|147730975|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
74088896|NCT04070287|147730976|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
74088897|NCT04070287|147730977|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
74088898|NCT04070287|147730978|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
74088899|NCT04070287|147730979|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
74088900|NCT02610816|147731023|SUPERIORITY|||||||0.04||||||P-values are not adjusted for multiplicity, since a single primary endpoint is analyzed|Mixed Models Analysis|No adjustment of degrees of freedom is needed.||The primary treatment comparison was to compare change in PEESS V2.0 scores of 1FED versus 4FED. The primary null hypothesis was 4FED would be no more effective than 1FED. This was designed as a superiority trial.||||0.04
74088901|NCT02610816|147731024|SUPERIORITY||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p \<0.05.|Mixed Models Analysis|||||||<0.0001
74088902|NCT02610816|147731024|SUPERIORITY||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p \<0.05|Mixed Models Analysis|||||||<0.0001
74088903|NCT02610816|147731025|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74088904|NCT02610816|147731028|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||||||0.93
74088905|NCT02610816|147731029|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
74088906|NCT02610816|147731030|SUPERIORITY|||||||0.36|||||||Mixed Models Analysis|||||||0.36
74088907|NCT03438227|147731039|SUPERIORITY|||||||0.039|||||||Chi-squared|||||||0.039
74088908|NCT03438227|147731040|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
74088909|NCT03438227|147731041|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
74088910|NCT03438227|147731042|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
74088911|NCT03438227|147731043|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
73973093|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|1.59||||0.137|TWO_SIDED|95.0|-0.51|3.69||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.49|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||3.69|-0.51|0.137
73973094|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.648|TWO_SIDED|95.0|-3.68|2.29||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.46|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||2.29|-3.68|0.648
73973095|NCT02938923|147488343|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.135|TWO_SIDED|95.0|-5.29|0.72||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.50|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||0.72|-5.29|0.135
73973096|NCT02938923|147488344|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.821|TWO_SIDED|95.0|-0.073|0.058||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.23|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.058|-0.073|0.821
73973097|NCT02938923|147488344|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.789|TWO_SIDED|95.0|-0.082|0.108||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.27|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.108|-0.082|0.789
73973098|NCT02938923|147488344|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.672|TWO_SIDED|95.0|-0.075|0.116||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.42|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.116|-0.075|0.672
73973099|NCT02938923|147488344|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.703|TWO_SIDED|95.0|-0.013|0.009||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.38||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+T - EX+P)|0.009|-0.013|0.703
73973100|NCT02938923|147488344|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.803|TWO_SIDED|95.0|-0.017|0.014||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.25||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+T - EUC)|0.014|-0.017|0.803
73973101|NCT02938923|147488344|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.015|0.016||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.01||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+P - EUC)|0.016|-0.015|0.991
73973102|NCT00303459|147488385|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.831||||0.2508|TWO_SIDED|97.31|0.582|1.187|||Log Rank|||||1.187|0.582|0.2508
73973103|NCT00303459|147488386|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.963||||0.8385|TWO_SIDED|95.0|0.673|1.38|||Log Rank|||||1.380|0.673|0.8385
73973104|NCT00303459|147488387|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|21.8||||0.0106|TWO_SIDED|95.0|5.9|37.8|||Wilcoxon (Mann-Whitney)|||||37.8|5.9|0.0106
73973105|NCT00303459|147488388|SUPERIORITY_OR_OTHER_LEGACY||Relative risk of improvement|0.98||||1|TWO_SIDED|95.0|0.6|1.61|||Fisher Exact|||||1.61|0.60|1.0000
73973106|NCT00303459|147488389|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.855||||0.4974|TWO_SIDED|95.0|0.544|1.344|||Log Rank|||||1.344|0.544|0.4974
73973107|NCT00303459|147488390|SUPERIORITY_OR_OTHER_LEGACY||Percentage change over placebo|-23.52||||0.0003|TWO_SIDED|95.0|-33.69|-11.79|||Repeated measures analysis|||||-11.79|-33.69|0.0003
73973108|NCT00303459|147488391|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.9566|TWO_SIDED|95.0|-0.42|0.39|||Wilcoxon (Mann-Whitney)|||||0.39|-0.42|0.9566
73973109|NCT00303459|147488392|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.02||||0.5571|TWO_SIDED|95.0|-0.036|0.076|||Wilcoxon (Mann-Whitney)|||||0.076|-0.036|0.5571
73973110|NCT00303459|147488393|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2||||0.4086|TWO_SIDED|95.0|-3.7|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|-3.7|0.4086
73973111|NCT01570361|147488432|SUPERIORITY|||||||0.0009||||||Prior to the final analysis, study had two interim analyses. Hence alpha level is 0.0231 for primary analysis adjusted for the two interim analyses.|Log Rank|One-sided test||||||0.0009
73973112|NCT01570361|147488433|SUPERIORITY|||||||0.0118||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test||||||0.0118
73973113|NCT01570361|147488434|SUPERIORITY|||||||0.0041||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test||||||0.0041
73973114|NCT05513937|147488462|SUPERIORITY||Mean difference pre vs post|-15.2|STANDARD_DEVIATION|8.32|<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||||||<0.001
73973115|NCT02846545|147488464|SUPERIORITY||Least Square (LS) Mean|-0.178|||=|0.0004|TWO_SIDED|95.0|-0.28|-0.08|||Mixed Models Analysis|||||-0.08|-0.28|= 0.0004
73973116|NCT02846545|147488465|SUPERIORITY||LS Mean|-0.09|||=|0.802|TWO_SIDED|95.0|-0.81|0.63|||Mixed Models Analysis|||||0.63|-0.81|= 0.8020
73973117|NCT02846545|147488466|SUPERIORITY||Ratio of hypoglycemia rates|0.9|||=|0.0036|TWO_SIDED|95.0|0.838|0.966|||Poisson regression model|||Hypoglycemia rate was analyzed by using a Poisson regression model with the number of hypoglycemia events through Week 52 as the response, treatment and gender as fixed factors, age and baseline HbA1c as covariates, and the duration of study participation through week 52 in logarithm as an offset variable.||0.966|0.838|= 0.0036
74088912|NCT03438227|147731044|SUPERIORITY|||||||0.194|||||||Fisher Exact|||||||0.194
74088913|NCT03438227|147731045|SUPERIORITY|||||||0.414|||||||Chi-squared|||||||0.414
74088914|NCT03438227|147731046|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
74088915|NCT03438227|147731047|SUPERIORITY|||||||0.571|||||||t-test, 2 sided|||||||0.571
74088916|NCT03438227|147731048|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
74088917|NCT03438227|147731049|SUPERIORITY|||||||0.049|||||||Log Rank|||||||0.049
73936656|NCT01659021|147403842|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.18|0.37||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, immunoglobulin heavy chain variable region (IGHV) mutation, and disease status).|Log Rank||Hazard Ratio and 95% confidence intervals (CI) are from the proportional hazard model, adjusted for randomization stratification factors.|||0.37|0.18|<0.0001
73936657|NCT01659021|147403843|SUPERIORITY||Odds Ratio (OR)|16.85|||<|0.0001|TWO_SIDED|95.0|8.17|34.76||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.|||34.76|8.17|<0.0001
73936658|NCT01659021|147403844|SUPERIORITY||Odds Ratio (OR)|483.16|||<|0.0001|TWO_SIDED|95.0|94.63|2467.02||P-value was calculated from the CMH Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.|||2467.02|94.63|<0.0001
73936659|NCT01659021|147403845|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.247|TWO_SIDED|95.0|0.54|1.15||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, IGHV mutation, and disease status).|Log Rank|||||1.15|0.54|0.247
73936660|NCT01659021|147403846|OTHER||Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.17|0.51|||||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model without any adjustments.|||0.51|0.17|
73973118|NCT06468982|147488475|SUPERIORITY|To evaluate whether intra-aortic balloon pump catheter support contributes to a more rapid decrease in troponin levels and faster myocardial recovery, daily troponin levels were analyzed using mixed ANOVA.||||||0.05||||||The p-value was adjusted for multiple comparisons, and the threshold value was set at 0.05.|ANOVA|The hypothesis that IABP causes a rapid increase in troponin levels was analyzed using ANOVA, and the p-value was reported.||After testing for normality, the baseline characteristics of the two groups will be analyzed using the Student's t-test or the Mann-Whitney U-test for continuous variables and the chi-square test or Fisher's exact test for categorical variables. Differences between the intra-aortic balloon pump group and the control group in terms of repeated measurements will be analyzed using mixed ANOVA.||||0.05
73973119|NCT06468982|147488476|OTHER||Hazard Ratio, log|0.55|||<|0.05|TWO_SIDED|95.0|0.38|0.78|||Wilcoxon (Mann-Whitney)|||The prognostic value of risk factors for in-hospital mortality was evaluated by multivariate logistic regression analysis||0.78|0.38|<0.05
73973120|NCT02492711|147488493|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0334|TWO_SIDED|95.0|0.593|0.979|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||0.979|0.593|0.0334
73973121|NCT02492711|147488494|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.6204|TWO_SIDED|95.0|0.774|1.165|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||1.165|0.774|0.6204
73973122|NCT02492711|147488496|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0014|TWO_SIDED|95.0|0.556|0.87|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||0.870|0.556|0.0014
73973123|NCT05932407|147488499|SUPERIORITY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.1|2.0||||||Crude hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Crude hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.||2.0|0.1|
73936661|NCT02585895|147403881|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|74.2|||<|0.0001|TWO_SIDED|95.0|44.6|86.8|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by screening LDL-C level|Treatment difference used apheresis as the reference.|||86.8|44.6|< 0.0001
73936662|NCT02585895|147403882|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-52.74|STANDARD_ERROR_OF_MEAN|5.64|<|0.0001|TWO_SIDED|95.0|-64.18|-41.3|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.|||-41.30|-64.18|< 0.0001
73936663|NCT02585895|147403883|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-46.37|STANDARD_ERROR_OF_MEAN|4.67|<|0.0001|TWO_SIDED|95.0|-55.85|-36.9|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.|||-36.90|-55.85|< 0.0001
73936664|NCT02585895|147403884|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-35.8|STANDARD_ERROR_OF_MEAN|3.74|<|0.0001|TWO_SIDED|95.0|-43.39|-28.21|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.||||-28.21|-43.39|< 0.0001
73936665|NCT00924885|147403892|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The primary end-point was the 'overall pain experience', evaluated as described previously. Assuming the mean overall pain in the RN group to be 27 mm (value chosen after analysis of data from a previous study, Cerne et al., 2006) on VAS, with a standard deviation (SD) of 21.5 mm, 121 patients in each group would be needed to demonstrate a decrease in overall pain of 8 mm (30%) with 80% power and a significance level of 0.05 (two-tailed tests).||||0.04
73973124|NCT05932407|147488499|SUPERIORITY|Adjusted hazard ratio was adjusted from crude hazard ratio by covariance 1 (age and gender), and covariance 2 (antithrombotic drug administration, NSAID administration, and hypertension).|Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.1|1.9||||||Adjusted hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Adjusted hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.||1.9|0.1|
73973125|NCT04181736|147488505|OTHER||F-statistic|6.621||||0.02|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for circuit function, with five repeated measures for each circuit measure defining the cognitive control circuit.||||0.020
74088918|NCT03438227|147731050|SUPERIORITY|||||||0.933|||||||t-test, 2 sided|||||||0.933
74088919|NCT03438227|147731051|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
74088920|NCT03438227|147731052|SUPERIORITY|||||||0.633|||||||t-test, 2 sided|||||||0.633
73866570|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.16|||||TWO_SIDED|95.0|-23.54|-8.79||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.79|-23.54|
73866571|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.09|||||TWO_SIDED|95.0|-13.5|1.32||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.32|-13.50|
73866572|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.06|||||TWO_SIDED|95.0|-20.46|-5.65||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.65|-20.46|
73866573|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.31|||||TWO_SIDED|95.0|-22.69|-7.93||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.93|-22.69|
73866574|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.31|||||TWO_SIDED|95.0|-20.66|-5.96||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.96|-20.66|
73866575|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.06|||||TWO_SIDED|95.0|-16.44|-1.68||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-16.44|
73866576|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.44|||||TWO_SIDED|95.0|-21.82|-7.06||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.06|-21.82|
73866577|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.72|||||TWO_SIDED|95.0|-12.53|3.09||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.09|-12.53|
73936666|NCT00784810|147403894|NON_INFERIORITY_OR_EQUIVALENCE|As above.|Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|1.19||0.002|ONE_SIDED|90.0|-5.65||||Mixed Models Analysis|||To achieve a study with 80% power at the 1-sided 5% significance level, for the purposes of demonstrating non inferiority, a sample size of 98 subjects per treatment group was required, i.e. a total of 196 subjects completing the study.|||-5.65|0.002
73936667|NCT02508480|147403905|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect.||||0.66
73936668|NCT02508480|147403906|SUPERIORITY|||||||0.884||||||Group effect for Proactive Coping|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Proactive Coping."||||0.884
73936669|NCT02508480|147403906|SUPERIORITY|||||||0.543||||||Group effect for Avoidant Coping.|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Avoidant Coping."||||0.543
73936670|NCT02508480|147403907|SUPERIORITY|||||||0.135||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.135
73936671|NCT02508480|147403908|SUPERIORITY|||||||0.25||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the interpersonal function subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.25
73936672|NCT02508480|147403908|SUPERIORITY|||||||0.118||||||The p-value represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the intrapsychic foundations subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.118
73936673|NCT02508480|147403909|SUPERIORITY|||||||0.917||||||The p-value is for group effect for tcpm\_days\_participated.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect for tcpm\_days\_participated.||||0.917
73936674|NCT02508480|147403910|SUPERIORITY|||||||0.017||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.017
73866578|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.4|||||TWO_SIDED|95.0|-20.21|-4.59||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.59|-20.21|
73936675|NCT02508480|147403911|SUPERIORITY|||||||0.597||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.597
73866579|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.48|||||TWO_SIDED|95.0|-24.25|-8.71||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.71|-24.25|
73866580|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.19|||||TWO_SIDED|95.0|-19.94|-4.44||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.44|-19.94|
73866581|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.73|||||TWO_SIDED|95.0|-15.5|0.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.04|-15.50|
73866582|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.98|||||TWO_SIDED|95.0|-21.75|-6.21||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.21|-21.75|
73866583|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.45|||||TWO_SIDED|95.0|-0.53|13.42||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.42|-0.53|
73866584|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06|||||TWO_SIDED|95.0|-5.81|7.92||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.92|-5.81|
73866585|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-6.25|7.57||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.57|-6.25|
73866586|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.42|||||TWO_SIDED|95.0|-9.26|4.42||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.42|-9.26|
73936676|NCT02508480|147403912|SUPERIORITY|||||||0.076||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.076
73936677|NCT02508480|147403913|SUPERIORITY|||||||0.978||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.978
73936678|NCT01380327|147403916|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.7||||0.001|TWO_SIDED|95.0|1.2|2.3|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. high dose group (numerator=1.98).|Analysis compared cockroach SLIT -high dose, Placebo - high dose||2.3|1.2|0.001
73936679|NCT01380327|147403916|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.7|3.1|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. low dose group (numerator=2.69).|Analysis compared cockroach SLIT - low dose, placebo - low dose||3.1|1.7|<0.0001
73936680|NCT01380327|147403917|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3|||<|0.0001|TWO_SIDED|95.0|1.1|1.4|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. high dose group (numerator=1.32).|Analysis compared cockroach SLIT - high dose, placebo - high dose||1.4|1.1|<0.0001
73936681|NCT01380327|147403917|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.11|TWO_SIDED|95.0|1.0|1.2|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. low dose group (numerator=1.14).|Analysis compared cockroach SLIT - low dose, placebo - low dose||1.2|1.0|0.11
73973126|NCT04181736|147488510|OTHER||Cohen's d effect size|1.47|||<|0.001|TWO_SIDED|95.0|0.937|2.002||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in HDRS-17 depression scores from pre-treatment to week 2.||2.002|0.937|<0.001
73936682|NCT01380327|147403918|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.06|TWO_SIDED|95.0|1.0|2.4|||Mixed Models Analysis||Estimated value and associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. high dose group (numerator=1.57).|Analysis compared cockroach SLIT - high dose, placebo - high dose||2.4|1.0|0.06
73973127|NCT04181736|147488510|OTHER||Cohen's d effect size|3.152|||<|0.001|TWO_SIDED|95.0|2.757|3.547||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in HDRS-17 depression scores from pre-treatment to post-treatment sessions.||3.547|2.757|<0.001
73973128|NCT04181736|147488511|OTHER||Cohen's d effect size|-1.249|||<|0.001|TWO_SIDED|95.0|-1.724|-0.774||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in QIDS-SR depression scores from pre-treatment to post-treatment sessions.||-0.774|-1.724|< 0.001
73973129|NCT04181736|147488512|OTHER||F-statistic|19.362|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for cognitive control function, with six repeated measures for behavioral tests of cognitive control.||||<0.001
73973130|NCT04181736|147488513|OTHER||Cohen's d effect size|0.881||||0.002|TWO_SIDED|95.0|0.324|1.438||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in SWLS scores from pre-treatment to post-treatment sessions.||1.438|0.324|0.002
74030602|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.195|||<|0.0001|TWO_SIDED|95.0|1.12|1.275|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.275|1.120|<0.0001
73866587|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.91|||||TWO_SIDED|95.0|1.48|16.35||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||16.35|1.48|
73866588|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.13|||||TWO_SIDED|95.0|-3.24|11.51||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.51|-3.24|
73866589|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|||||TWO_SIDED|95.0|-6.96|7.84||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.84|-6.96|
73866590|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|-5.14|9.56||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.56|-5.14|
73936683|NCT01380327|147403918|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.4||||0.13|TWO_SIDED|95.0|0.9|2.2|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. low dose group (numerator=1.45).|Analysis compared cockroach SLIT - low dose, placebo - low dose||2.2|0.9|0.13
73936684|NCT01380327|147403919|SUPERIORITY_OR_OTHER||Treatment effect|-12.9||||0.21|TWO_SIDED|95.0|-33.2|7.5|||Mixed Models Analysis||Estimated value\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (-7.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - high dose, placebo - high dose||7.5|-33.2|0.21
73936685|NCT01380327|147403919|SUPERIORITY_OR_OTHER||Treatment effect|13.5||||0.2|TWO_SIDED|95.0|-7.1|34.1|||Mixed Models Analysis||Estimated value\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (19.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - low dose, placebo - low dose||34.1|-7.1|0.20
73973131|NCT04181736|147488514|OTHER||F-statistic|11.913||||0.003|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for quality with four repeated measures for domains of quality of life.||||0.003
74088921|NCT02691741|147731059|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.0193|||TWO_SIDED|90.0|-0.093|-0.029||||||||-0.029|-0.093|
73866591|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.35|||||TWO_SIDED|95.0|0.92|15.77||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.77|0.92|
73866592|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.38|||||TWO_SIDED|95.0|-6.03|8.8||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.80|-6.03|
73866593|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||||TWO_SIDED|95.0|-8.26|6.52||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.52|-8.26|
73866594|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|||||TWO_SIDED|95.0|-6.23|8.49||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.49|-6.23|
73936686|NCT02105948|147403936|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.82|||=|0.036|TWO_SIDED|95.0|0.68|0.98||Adjusted p-value to account for two treatment comparisons|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted for FEV1,smoking status and offset of log (time in on-and off-treatment period)|||0.98|0.68|=0.036
73936687|NCT02105948|147403936|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.82|||=|0.029|TWO_SIDED|95.0|0.68|0.98||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||0.98|0.68|=0.029
73936688|NCT02105948|147403937|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.98|||>|0.999|TWO_SIDED|95.0|0.85|1.12||Adjusted p-value to account for two treatment comparisons|Negative Binomial Model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||1.12|0.85|>0.999
73973132|NCT04181736|147488515|OTHER||Cohen's d effect size|-0.2||||0.283|TWO_SIDED|95.0|-0.608|0.208||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in C-SSRS scores from pre-treatment to post-treatment sessions.||0.208|-0.608|0.283
74088922|NCT02691741|147731060|SUPERIORITY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.0193||0.002|TWO_SIDED|90.0|-0.093|-0.029|||Repeated Measures Analysis of Variance|||||-0.029|-0.093|0.002
74088923|NCT02691741|147731061|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.0157|||TWO_SIDED|95.0|-0.019|0.043||||||||0.043|-0.019|
73973133|NCT01116895|147488535|OTHER||Least square mean difference|-2.2||||0.89|TWO_SIDED|95.0|-32.6|28.2|||ANOVA|||||28.2|-32.6|0.89
73973134|NCT01116895|147488535|OTHER||Least square mean difference|4.5||||0.77|TWO_SIDED|95.0|-26.2|35.3|||ANOVA|||||35.3|-26.2|0.77
73973135|NCT01116895|147488535|OTHER||Least square mean difference|-6.7||||0.65|TWO_SIDED|95.0|-36.2|22.8|||ANOVA|||||22.8|-36.2|0.65
73973136|NCT04109066|147488540|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0021|TWO_SIDED|95.0|1.29|3.27|||Cochran-Mantel-Haenszel||"Stratified by PD-L1 by SP142 (\< 1% vs. \>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT.~Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method."|Arm A over Arm B||3.27|1.29|0.0021
73973137|NCT04109066|147488540|OTHER||Adjusted Difference of pCR Rates|10.5|||||TWO_SIDED|95.0|4.0|16.9|||||"Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.~Stratified by PD-L1 by SP142 (\< 1% vs. \>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT."|||16.9|4.0|
73973138|NCT04109066|147488541|SUPERIORITY||Odds Ratio (OR)|3.11|||||TWO_SIDED|95.0|1.58|6.11|||||Stratified by AC Dose-Frequency. Chemotherapy Regimen (Q2W vs. Q3W) per IRT. Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method.|Arm A over Arm B||6.11|1.58|
73973139|NCT04109066|147488541|OTHER||Adjusted Difference of pCR Rates|24.1|||||TWO_SIDED|95.0|10.7|37.5|||||"Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.~Stratified by AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT."|||37.5|10.7|
73973140|NCT04505410|147488559|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73973141|NCT06262477|147488577|EQUIVALENCE|The natural log (ln)- transformed Cmax was analysed using analysis of covariance (ANCOVA) model, which included actual treatment \& body weight category (\<75 kilograms \[kg\], ≥75 kg) as factors. The ratio of geometric least square means (GLSM), and corresponding confidence interval (CI) was obtained by taking the exponential of the differences in LSMs and corresponding CIs on the ln scale.|Ratio of GLSM|1.05|||||TWO_SIDED|90.3|0.974|1.13||||||||1.13|0.974|
73973142|NCT06262477|147488578|EQUIVALENCE|The natural log (ln)- transformed AUC0-inf was analyzed using ANCOVA model, which included actual treatment \& body weight category (\<75 kg, ≥75 kg) as factors. The ratio of GLSM, and corresponding CI was obtained by taking the exponential of the differences in LSMs and corresponding CIs on the ln scale.|Ratio of GLSM|1.07|||||TWO_SIDED|90.3|0.988|1.15||||||||1.15|0.988|
73973143|NCT06262477|147488579|EQUIVALENCE|The natural log (ln)- transformed AUC0-t was analyzed using ANCOVA model, which included actual treatment \& body weight category (\<75 kg, ≥75 kg) as factors. The ratio of GLSM, and corresponding CI was obtained by taking the exponential of the differences in LSMs and corresponding CIs on the ln scale.|Ratio of GLSM|1.06|||||TWO_SIDED|90.3|0.985|1.15||||||||1.15|0.985|
73973144|NCT05365958|147488610|SUPERIORITY||||||<|0.001|||||||Repeated Measures t-test of differences|||||||<.001
73973145|NCT05365958|147488611|SUPERIORITY||||||<|0.001|||||||Repeated Measures t-test of differences|||||||<.001
73973146|NCT05098158|147488615|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||<0.001
73973147|NCT05098158|147488616|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|5.6||||0.003|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.003
74030603|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.0316|TWO_SIDED|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.359|1.040|0.0316
74088924|NCT02691741|147731061|SUPERIORITY|||||||0.455|||||||Repeated Measures Analysis of Variance|||||||0.455
74088925|NCT02691741|147731062|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.0168|||TWO_SIDED|90.0|-0.078|-0.023||||||||-0.023|-0.078|
74088926|NCT02691741|147731062|SUPERIORITY|||||||0.003|||||||Repeated Measures Analysis of Variance|||||||0.003
73973148|NCT05098158|147488617|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|3.1||||0.011|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.011
73973149|NCT05098158|147488618|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|1.9||||0.168|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.168
73973150|NCT05098158|147488619|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|1.1||||0.456|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.456
73973151|NCT05098158|147488620|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|0.8||||0.517|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.517
73973152|NCT05098158|147488621|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Net)|3.2||||0.012|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest data||||0.012
73973153|NCT05098158|147488622|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Net)|0.3||||0.811|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||||||0.811
73973154|NCT05098158|147488623|EQUIVALENCE|Paired t tests had .05 set as level of significance to reject null hypothesis. Sample powered to generate effect size for future studies.|Mean Difference (Final Values)|0.1||||0.941|TWO_SIDED|||||Actual p value results above; Not adjusted due to pilot study aim to generate effect size comparing pre and posttest data|t-test, 2 sided|||Paired t tests of pre and posttest dat||||0.941
73973155|NCT05098158|147488624|OTHER|Descriptive statistics to report the percentage of offered telehealth sessions that were attended \[#attended/#offered = % attended\]|percentage|95.8|||||TWO_SIDED|||||||||||||
73973156|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|2.49||||0.75|TWO_SIDED|90.0|-10.66|15.65|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||15.65|-10.66|0.75
73973157|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-5.37||||0.5|TWO_SIDED|90.0|-18.49|7.76|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||7.76|-18.49|0.50
73973158|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.83|TWO_SIDED|90.0|-11.48|14.84|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||14.84|-11.48|0.83
73973159|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.84|TWO_SIDED|90.0|-7.91|6.15|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||6.15|-7.91|0.84
73973160|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.66|TWO_SIDED|90.0|-5.13|8.9|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||8.90|-5.13|0.66
73973161|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.88|TWO_SIDED|90.0|-6.38|7.68|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||7.68|-6.38|0.88
73973162|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-53.83||||0.54|TWO_SIDED|90.0|-200.7|93.05|||ANOVA|||Ring/CA conc: 3% Type: ROI||93.05|-200.70|0.54
73973163|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-40.51||||0.65|TWO_SIDED|90.0|-187.01|105.98|||ANOVA|||Ring/CA conc: 3% Type: ROI||105.98|-187.01|0.65
73973164|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-52.99||||0.55|TWO_SIDED|90.0|-199.87|93.88|||ANOVA|||Ring/CA conc: 3% Type: ROI||93.88|-199.87|0.55
73973165|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-36.65||||0.18|TWO_SIDED|90.0|-81.85|8.56|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||8.56|-81.85|0.18
73973166|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-22.49||||0.41|TWO_SIDED|90.0|-67.58|22.59|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||22.59|-67.58|0.41
73973167|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-33.86||||0.22|TWO_SIDED|90.0|-79.06|11.34|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||11.34|-79.06|0.22
73973168|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-30.66||||0.74|TWO_SIDED|90.0|-183.08|121.76|||ANOVA|||Ring/CA conc: 10%, Type: ROI||121.76|-183.08|0.74
73973169|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-98.77||||0.28|TWO_SIDED|90.0|-250.79|53.25|||ANOVA|||Ring/CA conc: 10%, Type: ROI||53.25|-250.79|0.28
73973170|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-214.89||||0.02|TWO_SIDED|90.0|-367.31|-62.48|||ANOVA|||Ring/CA conc: 10%, Type: ROI||-62.48|-367.31|0.02
73973171|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-3.89||||0.93|TWO_SIDED|90.0|-81.44|73.66|||ANOVA|||Ring/CA conc: 10% , Type: Entire Image||73.66|-81.44|0.93
73936689|NCT02105948|147403937|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.98|||=|0.731|TWO_SIDED|95.0|0.85|1.12||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||1.12|0.85|=0.731
73936690|NCT02105948|147403938|SUPERIORITY||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0.036|TWO_SIDED|95.0|0.6|0.94||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.94|0.60|=0.036
73936691|NCT02105948|147403938|SUPERIORITY||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0.012|TWO_SIDED|95.0|0.6|0.94||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.94|0.60|=0.012
73936692|NCT02105948|147403939|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.16|||=|0.598|TWO_SIDED|95.0|0.77|1.75||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.75|0.77|=0.598
73936693|NCT02105948|147403939|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.16|||=|0.479|TWO_SIDED|95.0|0.77|1.75||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.75|0.77|=0.479
73936694|NCT02105948|147403940|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|0.2|||>|0.999|TWO_SIDED|95.0|-2.8|3.2||Adjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||3.2|-2.8|>0.999
73936695|NCT02105948|147403940|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|0.2|||=|0.901|TWO_SIDED|95.0|-2.8|3.2||Unadjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||3.2|-2.8|=0.901
73936696|NCT02105948|147403941|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|-0.8|||>|0.999|TWO_SIDED|95.0|-2.0|0.5||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.5|-2.0|>0.999
73936697|NCT02105948|147403941|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|-0.8|||=|0.244|TWO_SIDED|95.0|-2.0|0.5||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.5|-2.0|=0.244
73936698|NCT02105948|147403942|SUPERIORITY||Hazard ratio (Mepolizumab/Placebo)|0.89|||>|0.999|TWO_SIDED|95.0|0.75|1.05||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.05|0.75|>0.999
73973172|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-191.02|||<|0.0001|TWO_SIDED|90.0|-268.37|-113.67|||ANOVA|||Ring/CA conc: 10% , Type: Entire Image||-113.67|-268.37|<.0001
73973173|NCT04183283|147488634|SUPERIORITY||Mean Difference (Final Values)|-252.24|||<|0.0001|TWO_SIDED|90.0|-329.79|-174.68|||ANOVA|||Ring/CA conc: 10%, Type: Entire Image||-174.68|-329.79|<.0001
73973174|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.99|TWO_SIDED|90.0|-8.28|8.15|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||8.15|-8.28|0.99
73973175|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.91|TWO_SIDED|90.0|-8.78|7.6|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||7.60|-8.78|0.91
73973176|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|2.53||||0.61|TWO_SIDED|90.0|-5.69|10.74|||ANOVA|||Ring/CA conc: Vehicle, Type: ROI||10.74|-5.69|0.61
73973177|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-1.29||||0.8|TWO_SIDED|90.0|-9.58|7.0|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||7.00|-9.58|0.80
73973178|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.77|TWO_SIDED|90.0|-6.83|9.72|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||9.72|-6.83|0.77
73973179|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|1.85||||0.71|TWO_SIDED|90.0|-6.45|10.14|||ANOVA|||Ring/CA conc: Vehicle, Type: Entire Image||10.14|-6.45|0.71
73973180|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-18.38||||0.38|TWO_SIDED|90.0|-53.27|16.51|||ANOVA|||Ring/CA conc: 3%, Type: ROI||16.51|-53.27|0.38
73973181|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-2.97||||0.89|TWO_SIDED|90.0|-37.76|31.83|||ANOVA|||Ring/CA conc: 3%, Type: ROI||31.83|-37.76|0.89
73973182|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-10.12||||0.63|TWO_SIDED|90.0|-45.0|24.77|||ANOVA|||Ring/CA conc: 3%, Type: ROI||24.77|-45.00|0.63
73973183|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-11.31||||0.21|TWO_SIDED|90.0|-26.21|3.58|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||3.58|-26.21|0.21
73973184|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-3.19||||0.72|TWO_SIDED|90.0|-18.04|11.67|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||11.67|-18.04|0.72
73866595|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.26|||||TWO_SIDED|95.0|1.46|17.06||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.06|1.46|
73936699|NCT02105948|147403942|SUPERIORITY||Hazard ratio (Mepolizumab/Placebo)|0.89|||=|0.16|TWO_SIDED|95.0|0.75|1.05||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.05|0.75|=0.160
73936700|NCT02105948|147403943|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.1|||>|0.999|TWO_SIDED|95.0|0.81|1.49||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.49|0.81|>0.999
73936701|NCT02105948|147403943|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.1|||=|0.556|TWO_SIDED|95.0|0.81|1.49||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.49|0.81|=0.556
73936702|NCT02105948|147403944|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|0.7|||>|0.999|TWO_SIDED|95.0|-1.5|2.9||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.9|-1.5|>0.999
73936703|NCT02105948|147403944|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|0.7|||=|0.532|TWO_SIDED|95.0|-1.5|2.9||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.9|-1.5|=0.532
73936704|NCT02105948|147403945|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|-0.6|||>|0.999|TWO_SIDED|95.0|-1.5|0.4||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.4|-1.5|>0.999
73936705|NCT02105948|147403945|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|-0.6|||=|0.252|TWO_SIDED|95.0|-1.5|0.4||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.4|-1.5|=0.252
73936706|NCT01934218|147403949|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-2.7|2.7|||Basic longitudinal model|||||2.7|-2.7|0.988
73936707|NCT01934218|147403950|OTHER|Euflexxa would be considered superior to Gel-One if the difference in mean change from baseline in VAS pain score at week 26 was 5 mm or greater (on the 100mm VAS pain scale). If the difference in mean change values were within 5 mm, Gel-One would not be considered inferior to Euflexxa.||||||||||||||||A post-hoc non-inferiority comparison of the Gel-One mean change from baseline in VAS pain score at week 26 (Following 50-foot walk test) against the same assessment collected from subjects treated with Euflexxa in a separate study (PMID:19539353) was also performed.|Change from baseline (95% CI) for Euflexxa was -25.7 (-29.0, -22.4) and the difference between Euflexxa and Gel-One (95% CI) was -3.8 (-inf, -0.3).|||
73936708|NCT02232893|147403951|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
73936709|NCT01587651|147403953|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was assessed using a 95% CI of the difference in mean PRU between ticagrelor and prasugrel (2 arms combined). Under the assumption of 0 difference in mean PRU between prasugrel 10 mg QD MD and ticagrelor 90 mg BID MD, a common SD of 60 PRU (based on previous DSI studies and published data), and a drop-out rate not exceeding 15%, a sample size of 105 allows for the 95% CI to stay within ± 45 PRU (non-inferiority margin) with a power of 90%.|Mean Difference (Final Values)|46.0|STANDARD_ERROR_OF_MEAN|10.66|||TWO_SIDED|95.0|24.9|67.2||||||ANCOVA model included treatment as a main effect and pre-randomization baseline PRU as a covariate. The combined prasugrel groups were modeled as a single treatment. If the upper limit of the CI for the mean difference was not greater than 45 PRU, then the PD response to prasugrel 10 mg QD MD was deemed noninferior to that achieved by ticagrelor 90 mg BID MD.||67.2|24.9|
73936710|NCT01660763|147403971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.59|STANDARD_ERROR_OF_MEAN|10.88|<|0.001|TWO_SIDED|95.0|66.2|108.98|||ANCOVA|||||108.98|66.20|<0.001
73936711|NCT03325712|147403973|OTHER||Slope|0.8188|STANDARD_ERROR_OF_MEAN|0.0725|||TWO_SIDED|90.0|0.6966|0.941|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9410|0.6966|
73936712|NCT03325712|147403974|OTHER||Slope|0.7708|STANDARD_ERROR_OF_MEAN|0.0747|||TWO_SIDED|90.0|0.6449|0.8967|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.8967|0.6449|
73936713|NCT03325712|147403975|OTHER||Slope|0.7167|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|0.4922|0.9412|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9412|0.4922|
73936714|NCT03325712|147403976|OTHER||Slope|0.6825|STANDARD_ERROR_OF_MEAN|0.1344|||TWO_SIDED|90.0|0.4556|0.9094|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9094|0.4556|
73866596|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.58|||||TWO_SIDED|95.0|-6.23|9.38||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.38|-6.23|
73936715|NCT03325712|147403977|OTHER||Ratio (T/R)|102.81|STANDARD_DEVIATION|17.5|||TWO_SIDED|90.0|87.18|121.25||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||121.25|87.18|
73936716|NCT03325712|147403977|OTHER||Ratio (T/R)|93.06|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|79.94|108.32||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||108.32|79.94|
73936717|NCT03325712|147403977|OTHER||Ratio (T/R)|109.82|STANDARD_DEVIATION|5.0|||TWO_SIDED|90.0|103.59|116.42||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||116.42|103.59|
73936718|NCT03325712|147403977|OTHER||Ratio ( T/R)|108.37|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|92.0|127.66||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||127.66|92.00|
73936719|NCT03325712|147403977|OTHER||Ratio (T/R)|109.11|STANDARD_DEVIATION|17.6|||TWO_SIDED|90.0|92.43|128.79||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||128.79|92.43|
73936720|NCT03325712|147403978|OTHER||Ratio (T/R)|100.1|STANDARD_DEVIATION|18.7|||TWO_SIDED|90.0|83.99|119.31||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||119.31|83.99|
73936721|NCT03325712|147403978|OTHER||Ratio (T/R)|84.43|STANDARD_DEVIATION|16.5|||TWO_SIDED|90.0|72.29|98.62||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||98.62|72.29|
73936722|NCT03325712|147403978|OTHER||Ratio (T/R)|109.41|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|94.34|126.88||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||126.88|94.34|
73936723|NCT03325712|147403978|OTHER||Ratio (T/R)|95.44|STANDARD_DEVIATION|19.1|||TWO_SIDED|90.0|79.75|114.21||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||114.21|79.75|
73973185|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-10.46||||0.25|TWO_SIDED|90.0|-25.35|4.44|||ANOVA|||Ring/CA conc: 3%, Type: Entire Image||4.44|-25.35|0.25
73973186|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|7.27||||0.69|TWO_SIDED|90.0|-22.71|37.25|||ANOVA|||Ring/CA conc: 10%, Type: ROI||37.25|-22.71|0.69
73973187|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-20.7||||0.25|TWO_SIDED|90.0|-50.6|9.2|||ANOVA|||Ring/CA conc: 10%, Type: ROI||9.2|-50.60|0.25
73973188|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-34.79||||0.06|TWO_SIDED|90.0|-64.77|-4.81|||ANOVA|||Ring/CA conc: 10%, Type: ROI||-4.81|-64.77|0.06
73973189|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|10.01||||0.51|TWO_SIDED|90.0|-15.4|35.42|||ANOVA|||Ring/CA conc: 10% Type: Entire Image||35.42|-15.4|0.51
73973190|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-53.63|||<|0.001|TWO_SIDED|90.0|-78.98|-28.29|||ANOVA|||Ring/CA conc: 10% Type: Entire Image||-28.29|-78.98|<0.001
73973191|NCT04183283|147488635|SUPERIORITY||Mean Difference (Final Values)|-79.5|||<|0.0001|TWO_SIDED|90.0|-104.91|-54.09|||ANOVA|||Ring/CA conc: 10% Type: Entire Image||-54.09|-104.91|<.0001
73973192|NCT03550170|147488641|NON_INFERIORITY|Non-inferiority was established using the prespecified margin of inferiority of 10 points on the total composite score of the Fatigue Impact Scale.|Slope|4.89|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|90.0|0.67|9.11|||||Comparison of teleconference to one-to-one at 6 months.|A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).||9.11|0.67|
73973193|NCT03550170|147488641|NON_INFERIORITY|Non-inferiority was established using the prespecified margin of inferiority of 10 points on the total composite score of the Fatigue Impact Scale.|Slope|6.12|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|90.0|0.98|11.26|||||Comparison of internet to one-to-one at 6 months.|A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).||11.26|0.98|
73973194|NCT03550170|147488642|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
73973195|NCT05850052|147488723|SUPERIORITY||Odds Ratio (OR)|1.24||||0.26|TWO_SIDED|95.0|0.85|1.79|||proportional-odds cumulative logit model|||||1.79|0.85|0.26
73973196|NCT05850052|147488724|SUPERIORITY||incidence rate ratio|1.02||||0.86|TWO_SIDED|97.5|0.82|1.27|||proportional-odds cumulative logit model|||||1.27|0.82|0.86
73973197|NCT05850052|147488725|SUPERIORITY||Risk Ratio (RR)|3.1||||0.36|TWO_SIDED|95.0|0.32|30.0|||Fisher Exact|||||30|0.32|0.36
73973198|NCT05552508|147488813|OTHER|||||||0.0327|||||||t-test, 2 sided|||All participants||||0.0327
73973199|NCT05552508|147488813|OTHER|||||||0.0359|||||||t-test, 2 sided|||Participants with \>=4 mucus plugs||||0.0359
73973200|NCT05552508|147488813|OTHER|||||||0.1088|||||||t-test, 2 sided|||Participants with \<4 mucus plugs||||0.1088
73973201|NCT05552508|147488813|OTHER|||||||0.0391|||||||t-test, 2 sided|||Non-OCS-dependent participants||||0.0391
73973202|NCT05552508|147488814|OTHER|||||||0.0423|||||||t-test, 2 sided|||||||0.0423
73866597|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-10.27|5.27||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.27|-10.27|
73973203|NCT05552508|147488815|OTHER|||||||0.9465|||||||t-test, 2 sided|||||||0.9465
73973204|NCT05552508|147488816|OTHER|||||||0.3455|||||||t-test, 2 sided|||||||0.3455
73973205|NCT05552508|147488817|OTHER|||||||0.2484|||||||t-test, 2 sided|||||||0.2484
73973206|NCT05552508|147488818|OTHER|||||||0.9405|||||||t-test, 2 sided|||||||0.9405
73973207|NCT05552508|147488819|OTHER|||||||0.6867|||||||t-test, 2 sided|||||||0.6867
73973208|NCT05552508|147488820|OTHER|||||||0.7554|||||||t-test, 2 sided|||||||0.7554
73973209|NCT02278211|147488856|OTHER||Hazard Ratio (HR)|1.25||||0.2|TWO_SIDED|95.0|0.89|1.76|||Log Rank|||||1.76|0.89|0.20
73973210|NCT02278211|147488857|OTHER||Hazard Ratio (HR)|2.43||||0.02|TWO_SIDED|95.0|1.15|5.12|||Log Rank|||||5.12|1.15|0.02
73973211|NCT06037668|147488931|SUPERIORITY|||||||0.1134||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1134
73973212|NCT06037668|147488932|SUPERIORITY|||||||0.0031||||||p-values are calculated by independent t-test|Independent t-test|||||||0.003100
73973213|NCT06037668|147488933|SUPERIORITY|||||||0.0503||||||p-values are calculated by independent t-test|Independent t-test|||||||0.050300
73973214|NCT06037668|147488934|SUPERIORITY|||||||0.1178||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1178
73973215|NCT06037668|147488935|SUPERIORITY|||||||0.1003||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1003
73973216|NCT06037668|147488936|SUPERIORITY|||||||0.4832||||||p-values are calculated by independent t-test|Independent t-test|||||||0.4832
73973217|NCT05970861|147488970|OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||"Null hypothesis: there is no statistical significance between the mean percentages of microbiota units of the main and control groups after the mare's milk administration.~Alternate hypothesis: statistical significance exists between the mean percentages of microbiota units of the main and control groups after the mare's milk administration."||||<0.05
73973218|NCT05970861|147488970|OTHER||||||<|0.05|||||||ANOVA|||"Null Hypothesis: The freeze-dried mare's milk does not significantly influence the mean percentages of gut microbiota units.~Alternate Hypothesis: The freeze-dried mare's milk significantly influences the mean percentages of gut microbiota units."||||<0.05
73973219|NCT05970861|147488971|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: No statistically significant difference exists between antiphospholipid antibody levels before and after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between antiphospholipid antibody levels before and after the mare's milk administration."||||>0.05
73973220|NCT05970861|147488972|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: No statistically significant difference exists between uric acid blood levels before and after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between uric acid blood levels before and after the mare's milk administration."||||0.01
73973221|NCT05970861|147488973|OTHER||||||<|0.01|||||||t-test, 2 sided|||"Null hypothesis: No statistically significant difference exists between the scores on a scale (PCS, MCS) after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between the scores on a scale (PCS, MCS) after the mare's milk administration."||||<0.01
73973222|NCT05970861|147488973|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Null hypothesis: No statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group.~Alternate hypothesis: Statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group."||||>0.05
73973223|NCT05970861|147488973|OTHER||||||<|0.01|||||||ANOVA|||"Null Hypothesis: The freeze-dried mare's milk does not significantly influence the scores on the scales (PCS, MCS).~Alternate Hypothesis: The freeze-dried mare's milk significantly influences the scores on the scales (PCS, MCS)."||||<0.01
74008334|NCT03627767|147566503|SUPERIORITY||LSM difference|0.6|||=|0.3339|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.8|-0.6|= 0.3339
73936724|NCT03325712|147403978|OTHER||Ratio (T/R)|90.04|STANDARD_DEVIATION|25.9|||TWO_SIDED|90.0|70.75|114.59||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||114.59|70.75|
73936725|NCT00952653|147403979|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|71.4|||||TWO_SIDED|90.0|65.08|78.33|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||78.33|65.08|
73936726|NCT00952653|147403980|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|86.08|||||TWO_SIDED|90.0|79.04|93.74|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||93.74|79.04|
73936727|NCT00952653|147403981|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|92.55|||||TWO_SIDED|90.0|87.43|97.97|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||97.97|87.43|
73936728|NCT00952653|147403982|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|101.17|||||TWO_SIDED|90.0|92.96|110.11|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||110.11|92.96|
73936729|NCT00952653|147403983|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|72.1|||||TWO_SIDED|90.0|66.04|78.72|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)||78.72|66.04|
73936730|NCT00952653|147403986|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|87.39|||||TWO_SIDED|90.0|80.42|94.96|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)||94.96|80.42|
73936731|NCT02265237|147403989|SUPERIORITY|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|100.0|||||TWO_SIDED|97.5|92.4|100.0|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||100.0|92.4|
73936732|NCT02265237|147403989|SUPERIORITY|97.5% confidence interval (CI) was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV GT4-infected subjects treated with pegIFN/RBV.|Percentage of Participants|96.6|||||TWO_SIDED|97.5|86.7|99.2|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||99.2|86.7|
73936733|NCT02265237|147403989|SUPERIORITY|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|93.4|||||TWO_SIDED|97.5|82.6|97.7|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||97.7|82.6|
73866598|NCT01393639|147278693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-5.95|9.53||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.53|-5.95|
73936734|NCT02265237|147403990|SUPERIORITY|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel (MH) proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|-3.39||||0.304|TWO_SIDED|95.0|-9.85|3.07|||Mantel Haenszel|||Within Part I (arm A and B), since superiority was demonstrated for both arms in the primary outcome measures, testing continued to the first secondary outcome measure.||3.07|-9.85|0.304
73936735|NCT02265237|147403991|SUPERIORITY|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|6.45||||0.086|TWO_SIDED|95.0|-0.91|13.81|||Mantel Haenszel|||Within Part II (arm C), since superiority was demonstrated for the primary outcome measure, testing continued to the second secondary outcome measure.||13.81|-0.91|0.086
73936736|NCT05003791|147404013|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
73936737|NCT05003791|147404014|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
73936738|NCT05003791|147404015|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
73936739|NCT00380068|147404016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.5|STANDARD_DEVIATION|65.64|<|0.001||95.0|11.8|29.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||29.3|11.8|<0.001
73936740|NCT00380068|147404017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|2.11|<|0.001||95.0|-0.8|-0.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||-0.3|-0.8|<0.001
73936741|NCT00380068|147404018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.001||95.0|-1.0|-0.2|||t-test, 2 sided|Paired t-test on change from Baseline to Week 48||||-0.2|-1.0|0.001
73936742|NCT00380068|147404019|SUPERIORITY_OR_OTHER||Percent change from baseline|-25.5||||||95.0|-33.6|-16.3|||||Percent change from baseline derived from Geometric Mean Ratio|||-16.3|-33.6|
73936743|NCT00380068|147404020|SUPERIORITY_OR_OTHER||Percent change from baseline|-29.2||||||95.0|-39.8|-16.6|||||Percent change from baseline derived from Geometric Mean Ratio|||-16.6|-39.8|
73936744|NCT00380068|147404021|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test|||||||<0.001
73936745|NCT00380068|147404022|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test|||||||<0.001
73936746|NCT00380068|147404023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||||<0.001
73866599|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.87|||||TWO_SIDED|95.0|-10.89|5.14||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.14|-10.89|
73936747|NCT00380068|147404024|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired t-test on change from Baseline to Week 48||||||<0.001
73936748|NCT00380068|147404025|SUPERIORITY_OR_OTHER||percent event free|89.4||||||95.0|84.4|92.8|||||Estimate obtained through Kaplan-Meier methods|||92.8|84.4|
73936749|NCT00380068|147404026|SUPERIORITY_OR_OTHER||percent event free|84.1||||||95.0|78.2|88.6|||||Estimate obtained through Kaplan-Meier methods|||88.6|78.2|
73936750|NCT00380068|147404027|SUPERIORITY_OR_OTHER||percent event free|95.3||||||95.0|91.4|97.4|||||Estimate obtained through Kaplan-Meier methods|||97.4|91.4|
73936751|NCT00380068|147404028|SUPERIORITY_OR_OTHER||percent event free|92.9||||||95.0|88.3|95.8|||||Estimate obtained through Kaplan-Meier methods|||95.8|88.3|
73936752|NCT00380068|147404029|SUPERIORITY_OR_OTHER||percent event free|95.0||||||95.0|88.5|97.9|||||Estimate obtained through Kaplan-Meier methods|||97.9|88.5|
73936753|NCT00380068|147404030|SUPERIORITY_OR_OTHER||percent event free|90.0||||||95.0|81.6|94.7|||||Estimate obtained through Kaplan-Meier methods|||94.7|81.6|
73936754|NCT00380068|147404031|SUPERIORITY_OR_OTHER||percent event free|97.1||||||95.0|93.6|98.7|||||Estimate obtained through Kaplan-Meier methods|||98.7|93.6|
73936755|NCT00380068|147404032|SUPERIORITY_OR_OTHER||percent event free|95.3||||||95.0|91.2|97.6|||||Estimate obtained through Kaplan-Meier methods|||97.6|91.2|
73936756|NCT01297062|147404033|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% confidence interval (CI), equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.36|||||TWO_SIDED|90.0|-2.21|-0.5||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-0.50|-2.21|
73936757|NCT01297062|147404034|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-2.02|||||TWO_SIDED|90.0|-2.88|-1.16||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-1.16|-2.88|
73866600|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.86|||||TWO_SIDED|95.0|-14.8|1.08||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.08|-14.80|
73866601|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.36|||||TWO_SIDED|95.0|-22.34|-6.38||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.38|-22.34|
73866602|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.32|||||TWO_SIDED|95.0|-20.22|-4.41||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.41|-20.22|
73866603|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.14|||||TWO_SIDED|95.0|-10.12|5.85||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.85|-10.12|
73866604|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.05|||||TWO_SIDED|95.0|-22.05|-6.04||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.04|-22.05|
73866605|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.26|||||TWO_SIDED|95.0|-9.83|7.3||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.30|-9.83|
73866606|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-18.67|-1.53||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.53|-18.67|
73866607|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.41|||||TWO_SIDED|95.0|-24.01|-6.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.82|-24.01|
73866608|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.79|||||TWO_SIDED|95.0|-20.33|-3.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.26|-20.33|
73866609|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.98|||||TWO_SIDED|95.0|-14.57|2.62||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.62|-14.57|
73936758|NCT01297062|147404035|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.13|||||TWO_SIDED|90.0|-2.11|-0.15||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-0.15|-2.11|
73936759|NCT01297062|147404036|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.47|||||TWO_SIDED|90.0|2.82|8.12|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||8.12|2.82|
73936760|NCT01297062|147404037|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.56|||||TWO_SIDED|90.0|8.46|12.67|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||12.67|8.46|
73936761|NCT01297062|147404038|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.92|||||TWO_SIDED|90.0|8.71|13.13|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||13.13|8.71|
73936762|NCT01297062|147404041|SUPERIORITY_OR_OTHER||Slope|0.0008||||0.5962|TWO_SIDED|90.0|-0.0017|0.0033|||Mixed Models Analysis||The linear mixed-effects model includes placebo-adjusted change from baseline in QTcP as response, plasma exenatide concentration as covariate, fixed intercept of zero, subject random slope.|The analysis is to test the significance of the linear regression slope (null hypothesis: slope equal to zero) between placebo-adjusted change from baseline in QTcP and exenatide concentration.||0.0033|-0.0017|0.5962
73973224|NCT03988621|147488983|SUPERIORITY||Mean Difference (Net)|-0.65||||0.04|TWO_SIDED|95.0|-1.27|-0.03||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean HSCN scale scores of participants in the intervention group were estimated to decrease by 0.65 (95% CI: -1.27 to -0.03) units more than that of participants in the control group from baseline to 6-months.|||-0.03|-1.27|0.04
73973225|NCT03988621|147488984|SUPERIORITY||Mean Difference (Net)|5.05||||0.01|TWO_SIDED|95.0|1.12|8.98||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean Self Care Inventory scale scores of participants in the intervention group were estimated to increase by 5.05 (95% CI: 1.12 to 8.98) units more than that of participants in the control group from baseline to 6-months.|||8.98|1.12|0.01
73973226|NCT03988621|147488985|SUPERIORITY||Mean Difference (Net)|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.48|-2.52||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean PSS scale scores of participants in the intervention group were estimated to decrease by 4.50 (95% CI: -6.48 to -2.52) units more than that of participants in the control group from baseline to 6-months.|||-2.52|-6.48|<0.0001
73973227|NCT03988621|147488986|SUPERIORITY||Mean Difference (Net)|2.16||||0.099|TWO_SIDED|95.0|-0.41|4.73||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis|||Active Coping Subscale||4.73|-0.41|0.099
74030604|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.495||||0.0024|TWO_SIDED|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.879|1.701|0.0024
74030605|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112||||0.0247|TWO_SIDED|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.219|1.014|0.0247
73973228|NCT03988621|147488986|SUPERIORITY||Mean Difference (Net)|-0.88||||0.25|TWO_SIDED|95.0|-2.38|0.62||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Estimated difference may not be consistent with difference sample means presented in outcome measure data table.|Avoidance Coping Subscale||0.62|-2.38|0.25
73973229|NCT03988621|147488986|SUPERIORITY|The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mean Difference (Net)|-0.31||||0.68|TWO_SIDED|95.0|-1.81|1.18|||Mixed Models Analysis|||Minimization Coping Subscale||1.18|-1.81|0.68
73973230|NCT03988621|147488987|SUPERIORITY||Mean Difference (Net)|-1.32||||0.27|TWO_SIDED|95.0|-3.68|1.04||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis|||Physical Health Score||1.04|-3.68|0.27
73973231|NCT03988621|147488987|SUPERIORITY||Mean Difference (Net)|3.35||||0.04|TWO_SIDED|95.0|0.17|6.53||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean Mental Health scores of participants in the intervention group were estimated to increase by 3.35 (95% CI: 0.17 to 6.53) units more than that of participants in the control group from baseline to 6-months.|Mental Health Score||6.53|0.17|0.04
73973232|NCT03988621|147488990|SUPERIORITY||Mean Difference (Final Values)|1.3472||||0.5433|TWO_SIDED|95.0|0.5153|3.5218|||Regression, zero inflated poisson||Estimation accounts for the zero-inflated distribution of hospitalization count, thus estimate is inconsistent with mean values in the Outcome Measure Data table|||3.5218|0.5153|0.5433
73973233|NCT03988621|147488991|SUPERIORITY||Mean Difference (Final Values)|1.0143||||0.9173|TWO_SIDED|95.0|0.7766|1.3247|||Zero-inflated poisson regression|||||1.3247|0.7766|0.9173
73973234|NCT03988621|147488992|SUPERIORITY|||||||0.6486|||||||Fisher Exact|||||||0.6486
73973235|NCT03988621|147488993|SUPERIORITY|||||||0.6791|||||||t-test, 2 sided|||||||0.6791
73866610|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.37|||||TWO_SIDED|95.0|-23.98|-6.76||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.76|-23.98|
73973236|NCT04778410|147489014|SUPERIORITY|||||||0.1794|||||||One Group Chi-Square test|The p-value was based on one group Chi-Square test for the null hypothesis CR rate was 0.19 at one-sided alpha of 0.1 in Cohort 2.||||||0.1794
74088927|NCT02139124|147731069|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.675|TWO_SIDED|95.0|-6.6|2.6||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo."||2.6|-6.6|0.6750
73973237|NCT00677365|147489042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96||||0.0014|TWO_SIDED|95.0|-1.54|-0.38||Repeated Measure Model|Mixed Models Analysis|||LS Mean Difference||-0.38|-1.54|0.0014
73973238|NCT00677365|147489043|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21||||0.0007|TWO_SIDED|95.0|0.09|0.52|||Regression, Cox|||Hazard Ratio for need of anti-pseudomonal antimicrobials; Estimates are obtained from a Cox proportional hazards regression model including terms for treatment, region, baseline P.aeruginosa density (log10 ), highest baseline MIC of levofloxacin against P. aeruginosa (log2 ), and baseline percent predicted FEV1 (quartiles)||0.52|0.09|0.0007
74088928|NCT02139124|147731069|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.0013|TWO_SIDED|95.0|-11.5|-2.2||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo||-2.2|-11.5|0.0013
73973239|NCT00677365|147489044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.61||||0.0026|TWO_SIDED|95.0|3.05|14.17|||Mixed Models Analysis|||LS Mean Difference Between MP-376 240 mg and Placebo groups||14.17|3.05|0.0026
73973240|NCT00677365|147489045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.94||||0.0008|TWO_SIDED|95.0|4.63|17.25|||Mixed Models Analysis|||LS Mean Difference Between Placebo and MP-376 240 mg BID groups||17.25|4.63|0.0008
73973241|NCT00677365|147489046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5||||0.2174|TWO_SIDED|95.0|-2.68|11.67|||Mixed Models Analysis|||LS Mean Difference from MP-376 240 mg BID to placebo groups||11.67|-2.68|0.2174
73973242|NCT01586910|147489081|NON_INFERIORITY|Non-inferiority margin was 0.07. Posterior threshold for non-inferiority was 0.971|Posterior Median of the Difference|-1.4|||||TWO_SIDED|||||The posterior probability of non-inferiority is \> 0.9999. The posterior probability is the probability of the event rate by updating the prior probability distribution with observed data using Bayes' Theorem.|Bayesian||95% Bayesian credible interval for the difference (TAVR-SAVR) was (-5.2%, 2.3%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.|Primary Hypothesis: TAVR with the Medtronic TAVR is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months.||||
74008335|NCT03627767|147566503|SUPERIORITY||LSM difference|0.5|||=|0.4653|TWO_SIDED|95.0|-0.8|1.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.7|-0.8|= 0.4653
73866611|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-9.49|9.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.03|-9.49|
73973243|NCT05507333|147489132|OTHER||Proportion of clinically cured patients|0.62|||||TWO_SIDED|95.0|0.4073|0.7909|||||"The proportion of clinically cured patients at Day 7-14 was calculated and presented together with a two-sided 95% CI based on the Wilson score for the proportion of Yes with continuity correction."|"It was assumed that the true clinical cure rate was 54% in the treatment group, therefore a sample size of 24 patients was needed to obtain 80% power to show that the one-sided 95% CI for the clinical cure rate was above 30%. A sample size of 26 was used to account for patients with missing data.~Hypotheses for the primary endpoint:~Null hypothesis: Clinical cure rate is less than or equal to 30%.~Alternative hypothesis (one-sided): Clinical cure rate is above 30%"||0.7909|0.4073|
73973244|NCT05507333|147489133|OTHER||Proportion with cont. clinical response|0.85|||||TWO_SIDED|95.0|0.5366|0.9729|||||"The proportion of participants with continued clinical response at Day 25 (Yes) was calculated and presented together with a two-sided 95% CI. The CI was based on the Wilson score for the proportion of Yes with a continuity correction."|||0.9729|0.5366|
73973245|NCT05507333|147489134|OTHER||Proportion with clin and mycol. cure|0.38|||||TWO_SIDED|95.0|0.2091|0.5927|||||"The proportion of participants with clinical and mycological cure at Day 7-14 (Yes) was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants with Yes with a continuity correction."|||0.5927|0.2091|
73973246|NCT05507333|147489135|OTHER||Proportion with mycological cure|0.54|||||TWO_SIDED|95.0|0.3375|0.7286|||||"The proportion of participants with mycological cure at Day 7-14 (Yes) was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants with Yes with a continuity correction."|||0.7286|0.3375|
73973247|NCT05507333|147489136|OTHER||Proportion with mycological cure|0.77|||||TWO_SIDED|95.0|0.4598|0.9384|||||"The proportion of participants with mycological cure at Day 25 (Yes) was calculated and presented with a 95% CI. The CI was based on the Wilson score for the proportion of participants recorded as Yes with a continuity correction."|||0.9384|0.4598|
73973248|NCT05507333|147489137|OTHER||Proportion with absence of Candida|0.58|||||TWO_SIDED|95.0|0.3719|0.7603|||||"The proportion of participants that did not show Candida hyphae in the wet smear (absence of/Yes) at Day 7-14 was calculated and presented together with a 95% CI based on the Wilson score for the proportion of Yes with a continuity correction."|||0.7603|0.3719|
73973249|NCT05507333|147489138|OTHER||Mean Difference (Net)|-4.5|STANDARD_DEVIATION|3.15|||TWO_SIDED|95.0|-5.77|-3.23|||||The mean change in the score for composite vulvovaginal signs and symptoms from Screening to Day 7-14 was calculated and presented together with a 95% CI.|||-3.23|-5.77|
73973250|NCT05507333|147489139|OTHER||Proportion with reduction CVVS score|0.88|||||TWO_SIDED|95.0|0.6872|0.9697|||||"The proportion of participants having a reduction in signs and symptoms (CVVS scores) on Day 7-14 vs. Screening was calculated and presented with a 95% CI based on the Wilson score for the prop. with Yes with a continuity correction."|||0.9697|0.6872|
73973251|NCT02585323|147489154|SUPERIORITY||Adjusted difference in mean change|13.1||||0.05|TWO_SIDED|95.0|1.6|24.5|||ANCOVA|||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in MVPA at 13 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking.||24.5|1.6|0.05
74030606|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.0258|TWO_SIDED|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.077|0.0258
73973252|NCT02585323|147489155|SUPERIORITY||Adjusted difference in mean change|-29.5||||0.05|TWO_SIDED|95.0|-75.8|16.7|||ANCOVA|||||16.7|-75.8|0.05
73973253|NCT02585323|147489156|SUPERIORITY||Adjusted difference in mean change|-1.4||||0.05|TWO_SIDED|95.0|-7.8|4.9|||ANCOVA|||||4.9|-7.8|0.05
73973254|NCT02585323|147489157|SUPERIORITY||Adjusted diff in mean change at T0-T1|2.5||||0.05|TWO_SIDED|95.0|-4.2|9.5|||ANCOVA|||||9.5|-4.2|0.05
73973255|NCT02585323|147489158|SUPERIORITY||Adjusted diff in mean change at T0-T1|-3.8||||0.05|TWO_SIDED|95.0|-14.9|7.2|||ANCOVA|||||7.2|-14.9|0.05
74030607|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.0009|TWO_SIDED|95.0|1.232|2.235|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.235|1.232|0.0009
73973256|NCT02585323|147489159|SUPERIORITY||Adjusted diff in mean change at T0-T1|2.8||||0.05|TWO_SIDED|95.0|-3.3|8.8|||ANCOVA|||||8.8|-3.3|0.05
73973257|NCT02585323|147489160|SUPERIORITY||Adjusted diff in mean change at T0-T1|1.4||||0.05|TWO_SIDED|95.0|-5.0|7.9|||ANCOVA|||||7.9|-5.0|0.05
73973258|NCT02585323|147489161|SUPERIORITY||Adjusted diff in mean change at T0-T1|-0.4||||0.05|TWO_SIDED|95.0|-1.7|0.8|||ANCOVA|||||0.8|-1.7|0.05
73973259|NCT02585323|147489162|SUPERIORITY||Adjusted diff in mean change at T0-T1|-2.3||||0.05|TWO_SIDED|95.0|-6.6|1.9|||ANCOVA|||||1.9|-6.6|0.05
73973260|NCT02585323|147489163|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.7||||0.05|TWO_SIDED|95.0|0.2|1.2|||ANCOVA|||||1.2|0.2|0.05
73973261|NCT02585323|147489164|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.7||||0.05|TWO_SIDED|95.0|0.2|1.1|||ANCOVA|||||1.1|0.2|0.05
73973262|NCT02585323|147489165|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.3||||0.05|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.05
73973263|NCT02585323|147489166|SUPERIORITY||Adjusted diff in mean change at T0-T1|-0.1||||0.05|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.05
73973264|NCT02585323|147489167|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.2||||0.05|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||||0.5|-0.1|0.05
73973265|NCT02585323|147489168|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.1||||0.05|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|||||0.8|-0.6|0.05
73973266|NCT02585323|147489169|SUPERIORITY||Adjusted diff in mean change at T0-T1|0.1||||0.05|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|||||0.3|-0.1|0.05
73973267|NCT05464069|147489179|SUPERIORITY|||||||0.16||||||Significant level \< 0.05|t-test, 2 sided|||||||0.160
73973268|NCT04881461|147489338|SUPERIORITY||Mean Difference (Final Values)|1.88||||0.0036|TWO_SIDED|95.0|0.6|3.17||Adjusted P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 86% power for the primary endpoint using the primary (trial product) estimand."||3.17|0.60|0.0036
74030608|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.255||||0.0045|TWO_SIDED|95.0|1.073|1.467|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.467|1.073|0.0045
74030609|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.086||||0.0001|TWO_SIDED|95.0|1.434|3.034|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.034|1.434|0.0001
73936763|NCT04964089|147404042|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.91||0.0083|TWO_SIDED|95.03|-3.88|-0.29|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA as covariates.||||-0.29|-3.88|0.0083
73936764|NCT01165281|147404050|NON_INFERIORITY_OR_EQUIVALENCE|In order to demonstrate that the upper limit of the confidence interval of intergroup differences in change from baseline is not higher than the noninferiority margin of 1 with a 1-tailed significance level of 0.025 and 90% power, the sample size was calculated to be 133 patients in each group for a total of 266 patients. Assuming approximately 20% of patients would be excluded from the analyses, the target sample size was 330 patients.|Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.226||0.786|TWO_SIDED|95.0|-0.506|0.383|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and country as factors and baseline pain intensity score as a covariate.||The primary hypothesis to be tested for the study was that the JNS024 ER group was not inferior to oxycodone CR as defined by the upper limit of the 95% confidence interval of the difference between JNS024 ER and oxycodone CR on the mean change from baseline of the NRS pain intensity score during the last 3 days of study drug administration. It was to be concluded that JNS024 ER is not inferior to oxycodone CR if the upper 95% confidence limit is less than 1 point.||0.383|-0.506|0.786
73936765|NCT02005471|147404066|SUPERIORITY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.18|0.29|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified analysis: 17p deletion, risk status, geographic region.||0.29|0.18|<.0001
73936766|NCT02005471|147404066|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model|Unstratified Analysis||0.31|0.19|<.0001
73973269|NCT04881461|147489339|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.1111|TWO_SIDED|95.0|-0.04|0.39||Adjusted P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction.|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 95% power for this key secondary endpoint using the primary (trial product) estimand."||0.39|-0.04|0.1111
74030610|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.318||||0.001|TWO_SIDED|95.0|0.16|0.63|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.630|0.160|0.0010
74030611|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.275||||0.0021|TWO_SIDED|95.0|0.121|0.626|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.626|0.121|0.0021
73936767|NCT02005471|147404068|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.28|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.28|0.13|<.0001
73936768|NCT02005471|147404068|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.14|0.3|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.30|0.14|<.0001
73936769|NCT02005471|147404070|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.21|0.57|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.||0.57|0.21|<.0001
73936770|NCT02005471|147404070|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.22|0.56|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.56|0.22|<.0001
73936771|NCT02005471|147404072|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.09|0.49|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.||0.49|0.09|<.0001
73936772|NCT02005471|147404072|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.09|0.46|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.46|0.09|<.0001
73936773|NCT02005471|147404073|SUPERIORITY||Difference in Response Rates|25.61|||<|0.0001|TWO_SIDED|95.0|17.88|33.33|||Cochran-Mantel-Haenszel||95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.|||33.33|17.88|<.0001
73936774|NCT02005471|147404073|SUPERIORITY||Odds Ratio (OR)|7.81|||||TWO_SIDED|95.0|3.97|15.37|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||15.37|3.97|
73866612|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.36|||||TWO_SIDED|95.0|-19.64|-1.08||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.08|-19.64|
73936775|NCT02005471|147404074|SUPERIORITY||Difference in Response Rates|25.61|||<|0.0001|TWO_SIDED|95.0|17.88|33.33|||Cochran-Mantel-Haenszel||95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.|||33.33|17.88|<.0001
73936776|NCT02005471|147404074|SUPERIORITY||Odds Ratio (OR)|7.81|||||TWO_SIDED|95.0|3.97|15.37|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||15.37|3.97|
73936777|NCT02005471|147404075|SUPERIORITY||Difference in Response Rates|25.07|||<|0.0001|TWO_SIDED|95.0|16.63|33.51|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.|||33.51|16.63|<.0001
73936778|NCT02005471|147404075|SUPERIORITY||Odds Ratio (OR)|4.59|||||TWO_SIDED|95.0|2.68|7.88|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||7.88|2.68|
73936779|NCT02005471|147404076|SUPERIORITY||Difference in Response Rates|24.55|||<|0.0001|TWO_SIDED|95.0|16.0|33.1|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.|||33.10|16.00|<.0001
73973270|NCT04881461|147489340|SUPERIORITY||Mean Difference (Final Values)|1.33||||0.0417|TWO_SIDED|95.0|-0.01|2.67||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||2.67|-0.01|0.0417
73973271|NCT04881461|147489341|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.4984|TWO_SIDED|95.0|-0.15|0.3||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass SLIT drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.30|-0.15|0.4984
73973272|NCT04881461|147489342|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.4438|TWO_SIDED|95.0|-0.12|0.27||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.27|-0.12|0.4438
73973273|NCT04881461|147489343|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.0363|TWO_SIDED|95.0|0.01|0.38||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.38|0.01|0.0363
73936780|NCT02005471|147404076|SUPERIORITY||Odds Ratio (OR)|4.59|||||TWO_SIDED|95.0|2.68|7.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||7.85|2.68|
73936781|NCT02005471|147404078|SUPERIORITY|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.|Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.37|0.74|||Log Rank||Hazard ratio was estimated by Cox regression model.|||0.74|0.37|0.0002
73936782|NCT02005471|147404078|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0003|TWO_SIDED|95.0|0.39|0.76|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.76|0.39|0.0003
73936783|NCT02005471|147404080|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.17|0.29|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.29|0.17|<.0001
73936784|NCT02005471|147404080|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.31|0.19|<.0001
73936785|NCT02005471|147404084|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.39|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.39|0.23|<.0001
73936786|NCT02005471|147404084|SUPERIORITY||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.25|0.41|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.41|0.25|<.0001
73936787|NCT02005471|147404085|SUPERIORITY||Difference in MRD Negativity Rates|49.04|||<|0.0001|TWO_SIDED|95.0|40.44|57.64|||Chi-squared||The 95% CI was computed using Anderson-Hauck method.|||57.64|40.44|<.0001
73936788|NCT02005471|147404085|SUPERIORITY||Odds Ratio (OR)|10.77|||||TWO_SIDED|95.0|6.5|17.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||17.85|6.50|
73936789|NCT02005471|147404086|SUPERIORITY||Difference in MRD negative rates|13.41|||<|0.0001|TWO_SIDED|95.0|7.99|18.82|||Chi-squared||The 95% CI was computed using Anderson-Hauck method.|||18.82|7.99|<.0001
73936790|NCT02005471|147404086|SUPERIORITY||Odds Ratio (OR)|16.28|||||TWO_SIDED|95.0|3.82|69.35|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||69.35|3.82|
73936791|NCT00627705|147404104|SUPERIORITY_OR_OTHER|||||||0.449|||||||mixed effects regression models|F= 0.81||Cohen's d = 0.30||||0.449
73936792|NCT00627705|147404106|SUPERIORITY_OR_OTHER||||||<|0.001||||||Aberrant Behavior Checklist irritability subscale (F = 6.80; p = \<.001; d = .96).|Mixed effects regression models|||F values were derived from the interaction of participant group (NAC vs. placebo) and time (week) in mixed effects regression models. Cohen's d was computed based on the standardized mean difference in the change from baseline to week 12.||||<.001
73936793|NCT00627705|147404108|SUPERIORITY_OR_OTHER|||||||0.141|||||||mixed effects regression models|degrees of freedom were 1, 22||F-values were derived from the interaction of Participant Group (NAC vs. Placebo) and Time (Week) in mixed effects regression models.||||.141
73936794|NCT04295564|147404124|SUPERIORITY||Mean Difference (Final Values)|82.1|||<|0.05|TWO_SIDED|95.0|8.3|155.9||This is a calculate p value|Mixed Models Analysis|adjusted for the correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient testing||||155.9|8.3|<0.05
73936795|NCT04295564|147404125|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.02|TWO_SIDED|95.0|0.1|1.1||This is a calculated p value|Mixed Models Analysis|Adjusted for correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient test.||||1.1|0.1|<0.02
73936796|NCT04295564|147404126|SUPERIORITY||Mean Difference (Final Values)|62.7|||<|0.05|TWO_SIDED|95.0|4.5|121.0||This is a calculated p value|Mixed Models Analysis|P-value adjusted for correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient testing.||||121|4.5|<0.05
73973274|NCT04881461|147489344|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.0329|TWO_SIDED|95.0|0.06|2.31||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.."||2.31|0.06|0.0329
73973275|NCT04881461|147489345|SUPERIORITY||Mean Difference (Final Values)|1.73||||0.0016|TWO_SIDED|95.0|0.66|2.79||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||2.79|0.66|0.0016
73973276|NCT04881461|147489346|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.4502|TWO_SIDED|95.0|-0.42|0.92||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.92|-0.42|0.4502
73973277|NCT04881461|147489347|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.1177|TWO_SIDED|95.0|-0.14|1.23||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.23|-0.14|0.1177
73973278|NCT04881461|147489348|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.4604|TWO_SIDED|95.0|-0.37|0.79||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.79|-0.37|0.4604
73973279|NCT04881461|147489349|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.0549|TWO_SIDED|95.0|-0.01|1.15||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.15|-0.01|0.0549
73866613|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.57|||||TWO_SIDED|95.0|-24.83|-6.32||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.32|-24.83|
73973280|NCT04881461|147489350|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.0049|TWO_SIDED|95.0|0.3|1.93||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.93|0.30|0.0049
73936797|NCT04295564|147404127|SUPERIORITY||Odds Ratio (OR)|0.59|||>|0.05|TWO_SIDED|95.0|0.27|1.31||This is a calculated p value|Regression, Logistic|||||1.31|0.27|>0.05
73936798|NCT04295564|147404127|SUPERIORITY||Odds Ratio (OR)|0.59|||>|0.05|TWO_SIDED|95.0|0.27|1.31|||Regression, Logistic|Adjusted for gestational age at birth (stratification variable)||||1.31|0.27|>0.05
73936799|NCT00321919|147404179|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.778976||||0.2036|TWO_SIDED|95.0|0.53|1.14|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first cardiovascular event in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|The null hypothesis stated that there was no difference with regard to the event-free distribution of the combined endpoint of all protocol specified cardiovascular events between Early Epoetin beta therapy and Late Epoetin beta therapy groups.||1.14|0.53|0.2036
73936800|NCT00321919|147404180|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.744575||||0.4833|TWO_SIDED|95.0|0.33|1.7|||Regression, Cox||The Cox regression model was used to estimate the relative risk of an event of the time to death due to cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|||1.70|0.33|0.4833
73936801|NCT00321919|147404182|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.658259||||0.1391|TWO_SIDED|95.0|0.38|1.15|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to death for all causes in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy treatment group.|||1.15|0.38|0.1391
73936802|NCT00321919|147404185|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.804594||||0.4985|TWO_SIDED|95.0|0.43|1.51|||Regression, Cox||The Cox regression model was used to estimate the relative risk of time to first cardiovascular intervention in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group|||1.51|0.43|0.4985
73973281|NCT04881461|147489351|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.0004|TWO_SIDED|95.0|0.54|1.95||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.95|0.54|0.0004
73973282|NCT04881461|147489352|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.0054|TWO_SIDED|95.0|0.25|1.63||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.63|0.25|0.0054
73973283|NCT04881461|147489353|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.0002|TWO_SIDED|95.0|0.52|1.71||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.71|0.52|0.0002
73973284|NCT04068792|147489354|OTHER||Mean Difference (Final Values)|-1.03|||||TWO_SIDED|90.0|-4.467|2.416||||||||2.416|-4.467|
73973285|NCT03663205|147489374|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.0054|TWO_SIDED|95.0|0.465|0.912|||One-sided, Log Rank Test||Stratified by stratification factors: disease stage (IIIB or IV) and the level of PD-L1 expression in tumor cells (\>=50%, 1% to 49%, \<1%)|||0.912|0.465|0.0054
73973286|NCT03663205|147489381|OTHER||Least squares mean difference|-2.2|||||TWO_SIDED|95.0|-7.4|3.1|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 coughing score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in coughing score||3.1|-7.4|
73973287|NCT03663205|147489381|OTHER||Least squares mean difference|-1.2|||||TWO_SIDED|95.0|-4.4|2.1|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 dyspnea score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in dyspnea score||2.1|-4.4|
73973288|NCT03663205|147489381|OTHER||Least squares mean difference|-3.2|||||TWO_SIDED|95.0|-7.6|1.2|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 chest pain score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in chest pain score||1.2|-7.6|
73973289|NCT03663205|147489382|OTHER||Least squares mean difference|3.9|||||TWO_SIDED|95.0|-0.9|8.7|||||Based on a constrained longitudinal data analysis model with QLQ-LC30 Global Health Status/Quality of Life score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in Global Health Status/Quality of Life score||8.7|-0.9|
73973290|NCT02577354|147489385|SUPERIORITY|||||||0.138||||||The threshold for statistical significance was p=0.05|Wald asymptotic test of proportions|Cui p-value adjustment for sample size re-estimation at interim analysis; Multiple imputation utilized for 3 participants lost to follow-up.||||||0.138
73973291|NCT02577354|147489386|SUPERIORITY|||||||0.032||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.032
73973292|NCT02577354|147489387|SUPERIORITY|||||||0.0499||||||The threshold for significance was p=0.05.|Friedman's regression analysis|Multiple Imputation utilized for 3 participants lost to follow-up.||||||0.0499
74030612|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.962||||0.0064|TWO_SIDED|95.0|0.935|0.989|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.989|0.935|0.0064
74030613|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.391|||<|0.0001|TWO_SIDED|95.0|1.245|1.553|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.553|1.245|<0.0001
73973293|NCT02577354|147489389|SUPERIORITY|||||||0.011||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.011
73973294|NCT02577354|147489390|SUPERIORITY|||||||0.009||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.009
73866614|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.34|||||TWO_SIDED|95.0|-20.56|-2.13||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.13|-20.56|
73866615|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.36|||||TWO_SIDED|95.0|-14.61|3.89||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.89|-14.61|
73936803|NCT00321919|147404187|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82046||||0.3419|TWO_SIDED|95.0|0.55|1.23|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first hospitalization for cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|||1.23|0.55|0.3419
73936804|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 1.||||0.0029
73936805|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 2||||0.0081
73936806|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Mental health scale of Quality of life for Year 1||||0.0005
73936807|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.0965|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Mental Health scale of Quality of life for Year 2||||0.0965
73936808|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 1||||0.0004
73936809|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.9864|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 2||||0.9864
73936810|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 1||||0.0097
73936811|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 2||||0.1670
73936812|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 1||||0.0058
73936813|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.1455|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 2||||0.1455
73936814|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 1||||0.0009
73936815|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.0123|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 2||||0.0123
73936816|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.3155|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 1||||0.3155
73936817|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.7076|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 2||||0.7076
73936818|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.1291|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 1||||0.1291
73936819|NCT00321919|147404194|SUPERIORITY_OR_OTHER|||||||0.5528|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 2||||0.5528
73936820|NCT02099838|147404204|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
73936821|NCT02099838|147404204|SUPERIORITY_OR_OTHER|||||||0.065||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0650
73936822|NCT02099838|147404204|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0005
73936823|NCT02099838|147404205|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
73936824|NCT02099838|147404205|SUPERIORITY_OR_OTHER|||||||0.0849||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0849
73936825|NCT02099838|147404205|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0005
73973295|NCT02577354|147489391|SUPERIORITY||||||<|0.001||||||Threshold for statistical significance was 0.05|t-test, 2 sided|||||||<0.001
73866616|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.88|||||TWO_SIDED|95.0|-25.15|-6.61||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.61|-25.15|
73936826|NCT02099838|147404206|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
73973296|NCT02577354|147489392|SUPERIORITY|||||||0.003||||||Threshold for statistical significance was p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.003
73866617|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-10.32|8.94||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.94|-10.32|
73866618|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.27|||||TWO_SIDED|95.0|-19.95|-0.59||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-19.95|
73866619|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.7|||||TWO_SIDED|95.0|-29.34|-10.06||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-10.06|-29.34|
73936827|NCT02099838|147404206|SUPERIORITY_OR_OTHER|||||||0.2428||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.2428
73936828|NCT02099838|147404206|SUPERIORITY_OR_OTHER|||||||0.0003||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0003
73936829|NCT02099838|147404207|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
73866620|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.65|||||TWO_SIDED|95.0|-22.25|-3.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.04|-22.25|
73866621|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.6|||||TWO_SIDED|95.0|-17.24|2.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.04|-17.24|
73973297|NCT02577354|147489393|SUPERIORITY|||||||0.335||||||Threshold for statistical significance was p=0.05.|Chi-squared|||||||0.335
73973298|NCT02577354|147489401|SUPERIORITY|||||||0.048||||||The threshold for statistical significance was p=0.05.|Wald asymptotic test of proportions|Multiple imputation used for three participants lost to follow-up.||||||0.048
73973299|NCT02577354|147489402|SUPERIORITY||||||<|0.001||||||"P-value for Satisfied with Treatment. Threshold for statistical significance was p=0.05"|Cochran-Mantel-Haenszel|||||||<0.001
73973300|NCT02577354|147489404|SUPERIORITY||||||<|0.001||||||Threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||<0.001
74030614|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.295||||0.0029|TWO_SIDED|95.0|1.092|1.535|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.535|1.092|0.0029
74030615|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.109|||<|0.0001|TWO_SIDED|95.0|0.05|0.236|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.236|0.050|<0.0001
74030616|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.0014|TWO_SIDED|95.0|0.159|0.645|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.645|0.159|0.0014
73936830|NCT02099838|147404207|SUPERIORITY_OR_OTHER|||||||0.7353||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Placebo group.. The test was performed with a significance level of 0.05.||||0.7353
73936831|NCT02099838|147404207|SUPERIORITY_OR_OTHER|||||||0.0013||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0013
73936832|NCT02099838|147404208|SUPERIORITY_OR_OTHER|||||||0.1147||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.1147
73936833|NCT02099838|147404208|SUPERIORITY_OR_OTHER|||||||0.4006||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.4006
73936834|NCT02099838|147404208|SUPERIORITY_OR_OTHER|||||||0.0614||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0614
73936835|NCT02099838|147404209|SUPERIORITY_OR_OTHER|||||||0.3795||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.3795
73936836|NCT02099838|147404209|SUPERIORITY_OR_OTHER|||||||0.4236||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.4236
73936837|NCT02099838|147404209|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||1.0000
73936838|NCT02099838|147404210|SUPERIORITY_OR_OTHER|||||||0.3151||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.3151
73936839|NCT02099838|147404210|SUPERIORITY_OR_OTHER|||||||0.6963||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.6963
73936840|NCT02099838|147404210|SUPERIORITY_OR_OTHER|||||||0.3204||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.3204
73936841|NCT02099838|147404211|SUPERIORITY_OR_OTHER|||||||0.0038||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.0038
73936842|NCT02099838|147404211|SUPERIORITY_OR_OTHER|||||||0.3812||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.3812
73936843|NCT02099838|147404211|SUPERIORITY_OR_OTHER|||||||0.0108||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0108
73973301|NCT03734029|147489433|SUPERIORITY||Cox Proportional Hazard|0.5085|||<|0.0001|TWO_SIDED|95.0|0.4012|0.6444||Two-sided p-value from stratified log-rank test, Hazard ratio and 95% CI from stratified Cox proportional hazards model using stratification factors: HER2 status, number of prior lines of chemotherapy, hormone Receptor/CDK status, as defined by IXRS.|Log Rank|||||0.6444|0.4012|<0.0001
73973302|NCT06946888|147489445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.837||||||This is the first week of tracking. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.837
73973303|NCT06946888|147489445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.428||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.428
73973304|NCT06946888|147489445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.269||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.269
74008336|NCT03627767|147566503|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-1.3|1.1||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.1|-1.3|
74008337|NCT03627767|147566503|SUPERIORITY||LSM difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-6.2|-2.3|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.3|-6.2|< 0.0001
73866622|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.34|||||TWO_SIDED|95.0|-28.99|-9.68||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-9.68|-28.99|
73866623|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.17|||||TWO_SIDED|95.0|3.18|19.16||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||19.16|3.18|
74008338|NCT03627767|147566503|SUPERIORITY||LSM difference|-6.2|||<|0.0001|TWO_SIDED|95.0|-8.2|-4.3|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-4.3|-8.2|< 0.0001
74008339|NCT03627767|147566503|SUPERIORITY||LSM difference|-2.0|||||TWO_SIDED|95.0|-3.6|-0.3||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-3.6|
74008340|NCT03627767|147566503|SUPERIORITY||LSM difference|0.1|||=|0.9083|TWO_SIDED|95.0|-1.8|2.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||2.1|-1.8|= 0.9083
74008341|NCT03627767|147566503|SUPERIORITY||LSM difference|-1.1|||=|0.2439|TWO_SIDED|95.0|-3.0|0.8|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.8|-3.0|= 0.2439
73866624|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.19|||||TWO_SIDED|95.0|-0.78|15.15||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.15|-0.78|
73866625|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-8.28|7.65||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.65|-8.28|
73973305|NCT06946888|147489445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.015||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.015
73866626|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.73|||||TWO_SIDED|95.0|-6.14|9.61||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.61|-6.14|
73866627|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.11|||||TWO_SIDED|95.0|5.51|22.71||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.71|5.51|
73866628|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.27|||||TWO_SIDED|95.0|-3.38|13.92||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.92|-3.38|
73866629|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-8.68|8.59||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.59|-8.68|
73973306|NCT06946888|147489445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.163||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.163
73866630|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.58|||||TWO_SIDED|95.0|-4.99|12.15||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.15|-4.99|
73866631|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.65|||||TWO_SIDED|95.0|6.38|24.93||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||24.93|6.38|
73866632|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.53|||||TWO_SIDED|95.0|-3.81|14.86||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.86|-3.81|
73936844|NCT02099838|147404212|SUPERIORITY_OR_OTHER|||||||0.5476||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.5476
73936845|NCT02099838|147404212|SUPERIORITY_OR_OTHER|||||||0.1248||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.1248
73936846|NCT02099838|147404212|SUPERIORITY_OR_OTHER|||||||0.362||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.3620
73936847|NCT02099838|147404213|SUPERIORITY_OR_OTHER|||||||0.5636||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.5636
73936848|NCT02099838|147404213|SUPERIORITY_OR_OTHER|||||||0.3681||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.3681
73936849|NCT02099838|147404213|SUPERIORITY_OR_OTHER|||||||0.2589||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.2589
73936850|NCT02099838|147404214|SUPERIORITY_OR_OTHER|||||||0.7972||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.7972
73936851|NCT02099838|147404214|SUPERIORITY_OR_OTHER|||||||0.7801||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.7801
73936852|NCT02099838|147404214|SUPERIORITY_OR_OTHER|||||||0.8744||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.8744
73936853|NCT02099838|147404215|SUPERIORITY_OR_OTHER|||||||0.8034||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.8034
73936854|NCT02099838|147404215|SUPERIORITY_OR_OTHER|||||||0.7675||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.7675
73936855|NCT02099838|147404215|SUPERIORITY_OR_OTHER|||||||0.6918||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.6918
73936856|NCT02099838|147404216|SUPERIORITY_OR_OTHER|||||||0.0339||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.0339
73936857|NCT02099838|147404216|SUPERIORITY_OR_OTHER|||||||0.0997||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0997
73936858|NCT02099838|147404216|SUPERIORITY_OR_OTHER|||||||0.5015||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.5015
73936859|NCT03740490|147404229|SUPERIORITY||Mean Difference (Net)|-0.1||||0.284|TWO_SIDED|95.0|-0.28|0.08|||Mixed Models Analysis|||Each outcome was modeled using a mixed-effects regression with the change score as the dependent variable and treatment group (Smart-T vs. QuitGuide) as the predictor, restricted to participants who received or would have received that type of message.||0.08|-0.28|0.284
73936860|NCT03740490|147404230|SUPERIORITY||Mean Difference (Net)|0.06||||0.477|TWO_SIDED|95.0|-0.11|0.24|||Mixed Models Analysis|||||0.24|-0.11|0.477
73936861|NCT03740490|147404231|SUPERIORITY||Mean Difference (Net)|0.03||||0.456|TWO_SIDED|95.0|-0.05|0.1|||Mixed Models Analysis|||||0.10|-0.05|0.456
73936862|NCT03740490|147404232|SUPERIORITY||Mean Difference (Net)|-0.22||||0.215|TWO_SIDED|95.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.215
73936863|NCT00823719|147404244|SUPERIORITY_OR_OTHER||percentage of participants|69.0|||||TWO_SIDED|95.0|48.2|85.7|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + DHAP treatment.|||85.7|48.2|
73973307|NCT06946888|147489445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.14||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.140
73973308|NCT06946888|147489445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.079||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.079
73973309|NCT06946888|147489445|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.151||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.151
74008342|NCT03627767|147566503|SUPERIORITY||LSM difference|-1.2|||||TWO_SIDED|95.0|-2.6|0.1||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-2.6|
73866633|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-8.97|9.59||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.59|-8.97|
74008343|NCT03627767|147566503|SUPERIORITY||LSM difference|-0.3|||=|0.7405|TWO_SIDED|95.0|-2.4|1.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.7|-2.4|= 0.7405
74008344|NCT03627767|147566503|SUPERIORITY||LSM difference|-2.1|||=|0.041|TWO_SIDED|95.0|-4.1|-0.1|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-4.1|= 0.0410
74008345|NCT03627767|147566503|SUPERIORITY||LSM difference|-1.7|||||TWO_SIDED|95.0|-3.1|-0.4||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-3.1|
73936864|NCT00823719|147404244|SUPERIORITY_OR_OTHER||percentage of participants|55.0|||||TWO_SIDED|95.0|36.4|71.9|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + ICE treatment.|||71.9|36.4|
73936865|NCT00823719|147404244|SUPERIORITY_OR_OTHER||percentage of participants|61.0|||||TWO_SIDED|95.0|47.4|73.5|||||The estimated value represents the percentage of participants with OR for participants receiving Total Ofatumumab + Chemotherapy treatment.|||73.5|47.4|
73936866|NCT01866410|147404290|OTHER|||||||0.4|||||||Log Rank|||||||0.4
73936867|NCT01866410|147404291|OTHER|||||||0.5|||||||Log Rank|||||||0.5
73936868|NCT02219932|147404294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.006|TWO_SIDED|95.0|1.15|2.26|||Regression, Logistic||fampridine vs. placebo|Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||2.26|1.15|0.006
73973310|NCT06946888|147489446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.63||||||This is the first week of tracking. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.63
73973311|NCT06946888|147489446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.608||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.608
73973312|NCT06946888|147489446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.244||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.244
73973313|NCT06946888|147489446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.052||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.052
73973314|NCT06946888|147489446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.229||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.229
73973315|NCT06946888|147489446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.184||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.184
73973316|NCT06946888|147489446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.148||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.148
74088929|NCT02139124|147731069|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.672|TWO_SIDED|95.0|-6.8|2.7||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"||2.7|-6.8|0.6720
73936869|NCT02219932|147404294|SUPERIORITY_OR_OTHER||Risk Difference for Adjusted Proportions|0.104|||||TWO_SIDED|95.0|0.03|0.178||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||0.178|0.030|
73936870|NCT02219932|147404294|SUPERIORITY_OR_OTHER||Relative Risk|1.38|||||TWO_SIDED|95.0|1.06|1.7||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||1.70|1.06|
73936871|NCT02219932|147404295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.03|TWO_SIDED|95.0|1.04|2.07|||Regression, Logistic|||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||2.07|1.04|0.030
73936872|NCT02219932|147404295|SUPERIORITY_OR_OTHER||Risk Difference for Adjusted Proportions|0.092|||||TWO_SIDED|95.0|0.009|0.175||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||0.175|0.009|
73936873|NCT02219932|147404295|SUPERIORITY_OR_OTHER||Relative Risk|1.25|||||TWO_SIDED|95.0|0.99|1.51||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||1.51|0.99|
73936874|NCT02219932|147404296|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.31|STANDARD_ERROR_OF_MEAN|0.925|<|0.001|TWO_SIDED|95.0|-5.13|-1.5|||mixed model for repeated measures|||||-1.50|-5.13|< 0.001
73866634|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.54|||||TWO_SIDED|95.0|-4.69|13.77||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.77|-4.69|
73936875|NCT02219932|147404297|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.277||0.141|TWO_SIDED|95.0|-0.13|0.95|||mixed model for repeated measures|||||0.95|-0.13|0.141
73936876|NCT02219932|147404298|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.573||0.197|TWO_SIDED|95.0|-0.38|1.86|||mixed model for repeated measures|||||1.86|-0.38|0.197
73936877|NCT01306162|147404323|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|STANDARD_DEVIATION|19.9||1|TWO_SIDED|90.0|191.0|240.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation.|150mg DE + 400mg DR same time (TrtB) vs 150mg DE (TrtA)||240|191|1.0000
73936878|NCT01306162|147404323|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|130.0|STANDARD_DEVIATION|25.0||0.6697|TWO_SIDED|90.0|112.0|151.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||151|112|0.6697
73936879|NCT01306162|147404323|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|236.0|STANDARD_DEVIATION|21.8||0.9992||90.0|173.0|321.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||321|173|0.9992
73936880|NCT01306162|147404323|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|162.0|STANDARD_DEVIATION|20.1||0.9171|TWO_SIDED|90.0|119.0|221.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||221|119|0.9171
73936881|NCT01306162|147404324|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|187.0|STANDARD_DEVIATION|24.3||0.9999|TWO_SIDED|90.0|162.0|215.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||215|162|0.9999
73936882|NCT01306162|147404324|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|115.0|STANDARD_DEVIATION|31.2||0.2207|TWO_SIDED|90.0|95.0|138.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||138|95|0.2207
73936883|NCT01306162|147404324|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|225.0|STANDARD_DEVIATION|26.1||0.9946||90.0|156.0|326.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||326|156|0.9946
73936884|NCT01306162|147404324|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|133.0|STANDARD_DEVIATION|23.0||0.6221|TWO_SIDED|90.0|94.0|190.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||190|94|0.6221
73936885|NCT01306162|147404325|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|STANDARD_DEVIATION|20.7||1|TWO_SIDED|90.0|190.0|241.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||241|190|1.0000
73973317|NCT06946888|147489446|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.143||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.143
74030617|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.248||||0.539|TWO_SIDED|95.0|0.616|2.528|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.528|0.616|0.5390
74030618|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.604||||0.0223|TWO_SIDED|95.0|1.069|2.405|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.405|1.069|0.0223
74030619|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.444||||0.0056|TWO_SIDED|95.0|1.547|12.766|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||12.766|1.547|0.0056
74030620|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.403||||0.0267|TWO_SIDED|95.0|1.04|1.892|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.892|1.040|0.0267
74030621|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.226||||0.0018|TWO_SIDED|95.0|0.089|0.575|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.575|0.089|0.0018
74088930|NCT02139124|147731069|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.0002|TWO_SIDED|95.0|-12.9|-3.2||The model include terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"||-3.2|-12.9|0.0002
73973318|NCT06946888|147489447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.333||||||This is the first week of tracking. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.333
73973319|NCT06946888|147489447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.273||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.273
73866635|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.65|||||TWO_SIDED|95.0|9.03|28.27||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||28.27|9.03|
73936886|NCT01306162|147404325|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|132.0|STANDARD_DEVIATION|26.3||0.7223|TWO_SIDED|90.0|113.0|155.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||155|113|0.7223
73936887|NCT01306162|147404325|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|258.0|STANDARD_DEVIATION|24.6||0.9993||90.0|182.0|365.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||365|182|0.9993
73936888|NCT01306162|147404325|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|159.0|STANDARD_DEVIATION|21.5||0.8875|TWO_SIDED|90.0|114.0|222.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||222|114|0.8875
73936889|NCT01306162|147404326|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|180.0|STANDARD_DEVIATION|24.6||0.9998|TWO_SIDED|90.0|156.0|207.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||207|156|0.9998
73936890|NCT01306162|147404326|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|114.0|STANDARD_DEVIATION|29.4||0.1866|TWO_SIDED|90.0|95.0|136.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||136|95|0.1866
73936891|NCT01306162|147404326|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|234.0|STANDARD_DEVIATION|26.7||0.9958||90.0|160.0|340.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||340|160|0.9958
73936892|NCT01306162|147404326|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|126.0|STANDARD_DEVIATION|22.6||0.5164|TWO_SIDED|90.0|89.0|179.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||179|89|0.5164
73866636|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.07|||||TWO_SIDED|95.0|-0.64|18.78||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||18.78|-0.64|
73936893|NCT00968669|147404348|SUPERIORITY_OR_OTHER|||||||0.435|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.435
73936894|NCT00968669|147404348|SUPERIORITY_OR_OTHER|||||||0.828|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.828
73936895|NCT00968669|147404348|SUPERIORITY_OR_OTHER|||||||0.628|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.628
73936896|NCT00968669|147404349|SUPERIORITY_OR_OTHER|||||||0.271|||||||Pairwise Poisson Regression|||||||0.271
73936897|NCT00968669|147404349|SUPERIORITY_OR_OTHER|||||||0.319|||||||Pairwise Poisson Regression|||||||0.319
73936898|NCT00968669|147404349|SUPERIORITY_OR_OTHER|||||||0.502|||||||Pairwise Poisson Regression|||||||0.502
73936899|NCT00968669|147404350|SUPERIORITY_OR_OTHER|||||||0.756|||||||Pairwise Poisson Regression|||||||0.756
73936900|NCT00968669|147404350|SUPERIORITY_OR_OTHER|||||||0.047|||||||Pairwise Poisson Regression|||||||0.047
73936901|NCT00968669|147404350|SUPERIORITY_OR_OTHER|||||||1|||||||Pairwise Poisson Regression|||||||1.000
73936902|NCT00968669|147404351|SUPERIORITY_OR_OTHER|||||||0.1764|||||||Fisher Exact|||||||0.1764
73936903|NCT00968669|147404351|SUPERIORITY_OR_OTHER|||||||0.4031|||||||Fisher Exact|||||||0.4031
73936904|NCT00968669|147404351|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73936905|NCT00968669|147404352|SUPERIORITY_OR_OTHER|||||||0.8475|||||||Fisher Exact|||||||0.8475
73936906|NCT00968669|147404352|SUPERIORITY_OR_OTHER|||||||0.0811|||||||Fisher Exact|||||||0.0811
73936907|NCT00968669|147404352|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73936908|NCT00968669|147404353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.938||||0.144|||||||Log Rank|Stratified by atopic asthma and steroid use||||||0.144
73936909|NCT00968669|147404353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.618||||0.395|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.395
73936910|NCT00968669|147404353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.899||||0.863|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.863
73936911|NCT00968669|147404354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.717|||||||Log Rank|Stratified by atopic asthma and steroid use||||||0.717
73936912|NCT00968669|147404354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.467||||0.07|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.070
73936913|NCT00968669|147404354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.955||||0.934|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.934
73936914|NCT00968669|147404355|SUPERIORITY_OR_OTHER|||||||0.813|||||||ANOVA|||||||0.813
73973320|NCT06946888|147489447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.424||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.424
73973321|NCT06946888|147489447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.482||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.482
73973322|NCT06946888|147489447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.627||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.627
73973323|NCT06946888|147489447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.806||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.806
74008346|NCT03627767|147566503|SUPERIORITY||LSM difference|-1.0|||=|0.4026|TWO_SIDED|95.0|-3.5|1.4|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.4|-3.5|= 0.4026
74008347|NCT03627767|147566503|SUPERIORITY||LSM difference|-1.9|||=|0.0944|TWO_SIDED|95.0|-4.2|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-4.2|= 0.0944
73936915|NCT00968669|147404355|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||||||0.290
73936916|NCT00968669|147404355|SUPERIORITY_OR_OTHER|||||||0.303|||||||ANOVA|||||||0.303
73936917|NCT00968669|147404356|SUPERIORITY_OR_OTHER|||||||0.764|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo||||0.764
73936918|NCT00968669|147404357|SUPERIORITY_OR_OTHER|||||||0.986|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo||||0.986
73936919|NCT00968669|147404358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.955||||0.7171|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.7171
73936920|NCT00968669|147404358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.6219|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.6219
73936921|NCT00968669|147404358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.909||||0.6182|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.6182
73936922|NCT00968669|147404359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.712|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.7120
73936923|NCT00968669|147404359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.5086|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.5086
73936924|NCT00968669|147404359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.887||||0.5184|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.5184
73936925|NCT00968669|147404360|SUPERIORITY_OR_OTHER|||||||0.837|||||||Two-sample t-test|||||||0.837
73936926|NCT00968669|147404360|SUPERIORITY_OR_OTHER|||||||0.756|||||||Two-sample t-test|||||||0.756
73936927|NCT00968669|147404360|SUPERIORITY_OR_OTHER|||||||0.224|||||||Two-sample t-test|||||||0.224
73936928|NCT00968669|147404361|SUPERIORITY_OR_OTHER|||||||0.409|||||||Two-sample t-test|||||||0.409
73936929|NCT00968669|147404361|SUPERIORITY_OR_OTHER|||||||0.847|||||||Two-sample t-test|||||||0.847
73936930|NCT00968669|147404361|SUPERIORITY_OR_OTHER|||||||0.968|||||||Two-sample t-test|||||||0.968
73936931|NCT00968669|147404362|SUPERIORITY_OR_OTHER|||||||0.208|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo||||0.208
73936932|NCT00968669|147404363|SUPERIORITY_OR_OTHER|||||||0.574|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo||||0.574
73866637|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-10.0|9.28||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.28|-10.00|
73866638|NCT01393639|147278695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.69|||||TWO_SIDED|95.0|-2.91|16.29||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||16.29|-2.91|
73866639|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.37|-0.02||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.02|-0.37|
73866640|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.46|-0.11||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.11|-0.46|
73866641|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.45|-0.1||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.10|-0.45|
73866642|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.52|-0.18||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.52|
73866643|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|||||TWO_SIDED|95.0|-0.35|0.0||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.00|-0.35|
73866644|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.53|-0.18||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.53|
73866645|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.31|0.07||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.07|-0.31|
73866646|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.54|-0.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.17|-0.54|
73866647|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.47|-0.09||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.09|-0.47|
73866648|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-0.56|-0.18||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.56|
73866649|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.39|-0.01||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-0.39|
73866650|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.63|-0.25||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.25|-0.63|
73866651|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.34|0.05||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-0.34|
73866652|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.59|-0.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.20|-0.59|
73936933|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.03|0.92|||Mixed Model Repeated Measure Analysis||Mean difference = GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 4||0.92|-0.03|
73866653|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-0.51|-0.12||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.12|-0.51|
73936934|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|95.0|0.25|1.13|||Mixed Model Repeated Measure Analysis||Mean difference = GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4||1.13|0.25|
73866654|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.55|-0.16||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.16|-0.55|
73936935|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.246|||TWO_SIDED|95.0|-0.2|0.8|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4||0.80|-0.20|
74008348|NCT03627767|147566503|SUPERIORITY||LSM difference|-0.9|||||TWO_SIDED|95.0|-2.5|0.7||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-2.5|
73936936|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.292|||TWO_SIDED|95.0|-0.24|0.95|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5||0.95|-0.24|
73936937|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|0.279|||TWO_SIDED|95.0|-0.05|1.09|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg- Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5||1.09|-0.05|
73936938|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.319|||TWO_SIDED|95.0|-0.61|0.69|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5||0.69|-0.61|
73936939|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|0.235|||TWO_SIDED|95.0|0.15|1.11|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6||1.11|0.15|
73936940|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|95.0|-0.06|0.86|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6||0.86|-0.06|
73936941|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.259|||TWO_SIDED|95.0|-0.29|0.77|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6||0.77|-0.29|
73936942|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.61|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.1|1.12|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 7||1.12|0.10|
73936943|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|0.242|||TWO_SIDED|95.0|0.09|1.08|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||1.08|0.09|
73936944|NCT00833989|147404389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|95.0|-0.39|0.73|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||0.73|-0.39|
73936945|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.56|STANDARD_ERROR_OF_MEAN|4.981|||TWO_SIDED|95.0|-0.6|19.71|||Mixed Model Repeated Measures Analysis||Mean difference =GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 4||19.71|-0.60|
73936946|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.47|STANDARD_ERROR_OF_MEAN|4.801|||TWO_SIDED|95.0|-1.32|18.26|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4||18.26|-1.32|
73936947|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|5.47|||TWO_SIDED|95.0|-11.1|11.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4||11.24|-11.1|
73936948|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.58|STANDARD_ERROR_OF_MEAN|5.631|||TWO_SIDED|95.0|0.01|23.15|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5||23.15|0.01|
73973324|NCT06946888|147489447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.786||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.786
74008349|NCT03627767|147566504|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.211|0.341||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate p-value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% confidence interval (CI).||0.341|0.211|< 0.0001
74008350|NCT03627767|147566504|SUPERIORITY||Hazard Ratio (HR)|0.1|||<|0.0001|TWO_SIDED|95.0|0.07|0.136||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.136|0.070|< 0.0001
74088931|NCT00842530|147731130|SUPERIORITY|The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|30.2|||||TWO_SIDED|95.0|-13.4|56.6||||||Vaccine efficacy of CYD dengue vaccine: The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups.||56.6|-13.4|
74088932|NCT00842530|147731131|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|75.2|||||TWO_SIDED|95.0|-377.0|99.6||||||Vaccine efficacy against severe VCD (IDMC)||99.6|-377|
73936949|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.77|STANDARD_ERROR_OF_MEAN|5.411|||TWO_SIDED|95.0|-2.35|19.89|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5||19.89|-2.35|
73936950|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|6.195|||TWO_SIDED|95.0|-12.2|13.21|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5||13.21|-12.2|
73936951|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.66|STANDARD_ERROR_OF_MEAN|5.351|||TWO_SIDED|95.0|-1.34|20.66|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6||20.66|-1.34|
73936952|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.45|STANDARD_ERROR_OF_MEAN|5.198|||TWO_SIDED|95.0|-3.22|18.13|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6||18.13|-3.22|
73936953|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.63|STANDARD_ERROR_OF_MEAN|5.959|||TWO_SIDED|95.0|-22.9|1.6|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6||1.60|-22.9|
73936954|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.59|STANDARD_ERROR_OF_MEAN|6.134|||TWO_SIDED|95.0|-3.07|22.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 7||22.24|-3.07|
73936955|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.89|STANDARD_ERROR_OF_MEAN|5.948|||TWO_SIDED|95.0|-6.37|18.15|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||18.15|-6.37|
73936956|NCT00833989|147404390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.11|STANDARD_ERROR_OF_MEAN|6.768|||TWO_SIDED|95.0|-17.1|10.84|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 7||10.84|-17.1|
73936957|NCT00833989|147404391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.47|STANDARD_ERROR_OF_MEAN|7.047|||TWO_SIDED|95.0|-15.81|12.86|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||12.86|-15.81|
73936958|NCT00833989|147404391|SUPERIORITY_OR_OTHER||Median Difference (Net)|9.86|STANDARD_ERROR_OF_MEAN|6.852|||TWO_SIDED|95.0|-4.08|23.8|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4||23.80|-4.08|
73936959|NCT00833989|147404391|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|7.376|||TWO_SIDED|95.0|-20.41|9.6|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4||9.60|-20.41|
73936960|NCT00833989|147404391|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|10.04|||TWO_SIDED|95.0|-22.87|18.07|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7||18.07|-22.87|
73936961|NCT00833989|147404391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.03|STANDARD_ERROR_OF_MEAN|10.31|||TWO_SIDED|95.0|-15.95|26.0|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7||26.00|-15.95|
73936962|NCT00833989|147404391|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.07|STANDARD_ERROR_OF_MEAN|10.916|||TWO_SIDED|95.0|-32.29|12.15|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7||12.15|-32.29|
73936963|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|5.147|||TWO_SIDED|95.0|-10.4|10.61|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||10.61|-10.4|
73936964|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.75|STANDARD_ERROR_OF_MEAN|5.157|||TWO_SIDED|95.0|-7.75|13.26|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4||13.26|-7.75|
73866655|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.38|0.01||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.01|-0.38|
73936965|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.85|STANDARD_ERROR_OF_MEAN|5.409|||TWO_SIDED|95.0|-6.17|15.88|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4||15.88|-6.17|
73936966|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|6.504|||TWO_SIDED|95.0|-12.1|14.45|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 5||14.45|-12.1|
73936967|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|6.426|||TWO_SIDED|95.0|-11.0|15.12|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 5||15.12|-11.0|
73936968|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22|STANDARD_ERROR_OF_MEAN|6.82|||TWO_SIDED|95.0|-16.1|11.68|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 5||11.68|-16.1|
73936969|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|6.664|||TWO_SIDED|95.0|-12.9|14.18|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6||14.18|-12.9|
73936970|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|6.595||||95.0|-12.4|14.43|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6||14.43|-12.4|
73973325|NCT06946888|147489447|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.497||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.497
73973326|NCT06946888|147489448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.857||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.857
73973327|NCT06946888|147489448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.684||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.684
73973328|NCT06946888|147489448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.333||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.333
73973329|NCT06946888|147489448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.09||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.090
73973330|NCT06946888|147489448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.545||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.545
74088933|NCT00842530|147731131|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|50.3|||||TWO_SIDED|95.0|-585.0|96.4||||||Vaccine efficacy of against severe VCD (WHO 1999)||96.4|-585|
74088934|NCT00842530|147731132|SUPERIORITY|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|41.5|||||TWO_SIDED|95.0|-38.4|74.9||||||Vaccine efficacy:- 28 days Post-Inj. 2 up to Inj. 3||74.9|-38.4|
74088935|NCT00842530|147731132|SUPERIORITY|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|35.3|||||TWO_SIDED|95.0|3.3|56.5||||||Vaccine efficacy: 28 days Post-Inj. 2 up to end of Active Phase||56.5|3.3|
73936971|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|7.02|||TWO_SIDED|95.0|-15.2|13.32|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6||13.32|-15.2|
73936972|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.25|STANDARD_ERROR_OF_MEAN|6.953|||TWO_SIDED|95.0|-11.9|16.4|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 7||16.40|-11.9|
73936973|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.52|STANDARD_ERROR_OF_MEAN|6.909|||TWO_SIDED|95.0|-10.5|17.55|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 7||17.55|-10.5|
73936974|NCT00833989|147404392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|7.328|||TWO_SIDED|95.0|-15.4|14.39|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 7||14.39|-15.4|
73936975|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|3.42|||TWO_SIDED|95.0|-5.33|8.65|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||8.65|-5.33|
73936976|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|-7.56|6.96|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4||6.96|-7.56|
73936977|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|3.534|||TWO_SIDED|95.0|-2.67|11.78|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4||11.78|-2.67|
73936978|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|3.841|||TWO_SIDED|95.0|-5.78|9.89|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 5||9.89|-5.78|
73936979|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.35|STANDARD_ERROR_OF_MEAN|3.958|||TWO_SIDED|95.0|-10.4|5.72|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 5||5.72|-10.4|
73936980|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.44|STANDARD_ERROR_OF_MEAN|3.978|||TWO_SIDED|95.0|-6.68|9.55|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 5||9.55|-6.68|
73936981|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.46|STANDARD_ERROR_OF_MEAN|4.109|||TWO_SIDED|95.0|-4.94|11.85|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 6||11.85|-4.94|
73936982|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|4.235|||TWO_SIDED|95.0|-8.15|9.12|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 6||9.12|-8.15|
73936983|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|4.28|||TWO_SIDED|95.0|-7.97|9.5|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 6||9.50|-7.97|
73936984|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.04|STANDARD_ERROR_OF_MEAN|4.205|||TWO_SIDED|95.0|-5.53|11.61|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7||11.61|-5.53|
73936985|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.58|STANDARD_ERROR_OF_MEAN|4.376|||TWO_SIDED|95.0|-11.5|6.32|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7||6.32|-11.5|
73936986|NCT00833989|147404393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.73|STANDARD_ERROR_OF_MEAN|4.396|||TWO_SIDED|95.0|-5.22|12.69|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7||12.69|-5.22|
73936987|NCT00833989|147404394|SUPERIORITY_OR_OTHER|||||||0.926|||||||Fisher Exact|||Visit 4||||0.9260
73936988|NCT00833989|147404394|SUPERIORITY_OR_OTHER|||||||0.5647|||||||Fisher Exact|||Visit 6||||0.5647
73936989|NCT00833989|147404395|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.34|STANDARD_ERROR_OF_MEAN|0.896|||TWO_SIDED|95.0|-3.17|0.49|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 3||0.49|-3.17|
73936990|NCT00833989|147404395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.861|||TWO_SIDED|95.0|-1.95|1.57|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 3||1.57|-1.95|
73936991|NCT00833989|147404395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|0.933|||TWO_SIDED|95.0|-4.83|-1.02|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 3||-1.02|-4.83|
73936992|NCT00833989|147404395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.868|||TWO_SIDED|95.0|-2.47|1.08|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 4||1.08|-2.47|
73936993|NCT00833989|147404395|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.834|||TWO_SIDED|95.0|-1.98|1.44|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4||1.44|-1.98|
73936994|NCT00833989|147404395|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|0.904|||TWO_SIDED|95.0|-2.77|0.92|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4||0.92|-2.77|
73936995|NCT00833989|147404395|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.278|||TWO_SIDED|95.0|-3.64|1.57|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6||1.57|-3.64|
73936996|NCT00833989|147404395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|1.278|||TWO_SIDED|95.0|-2.97|2.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6||2.24|-2.97|
73936997|NCT00833989|147404395|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|-0.66|1.408|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6||1.408|-0.66|
73936998|NCT00833989|147404396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.46|STANDARD_ERROR_OF_MEAN|12.584|||TWO_SIDED|95.0|-6.11|45.04|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 1 mg/kg, Visit 4||45.04|-6.11|
73936999|NCT00833989|147404396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.99|STANDARD_ERROR_OF_MEAN|12.131|||TWO_SIDED|95.0|-3.66|45.64|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 5 mg/kg, Visit 4||45.64|-3.66|
73937000|NCT00833989|147404396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.79|STANDARD_ERROR_OF_MEAN|13.143|||TWO_SIDED|95.0|-14.9|38.5|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 15 mg/kg, Visit 4||38.50|-14.9|
73937001|NCT00833989|147404396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.71|STANDARD_ERROR_OF_MEAN|9.021|||TWO_SIDED|95.0|-2.63|34.06|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 1 mg/kg, Visit 6||34.06|-2.63|
73937002|NCT00833989|147404396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.56|STANDARD_ERROR_OF_MEAN|8.835|||TWO_SIDED|95.0|-6.38|29.5|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 5 mg/kg, Visit 6||29.50|-6.38|
73937003|NCT00833989|147404396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.49|STANDARD_ERROR_OF_MEAN|9.641|||TWO_SIDED|95.0|-27.1|12.08|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 15 mg/kg, Visit 6||12.08|-27.1|
73937004|NCT00833989|147404397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|1.849|||TWO_SIDED|95.0|-4.12|3.43|||ANCOVA||Mean difference= GSK249320 1 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 1 mg/kg, Visit 6||3.43|-4.12|
73937005|NCT00833989|147404397|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-3.96|3.62|||ANCOVA||Mean difference= GSK249320 5 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 5 mg/kg, Visit 6||3.62|-3.96|
73937006|NCT00833989|147404397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15|STANDARD_ERROR_OF_MEAN|2.037|||TWO_SIDED|95.0|-5.31|3.01|||ANCOVA||Mean difference= GSK249320 15 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 15 mg/kg, Visit 6||3.01|-5.31|
73937007|NCT00833989|147404398|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|1.408|||TWO_SIDED|95.0|-3.12|2.63|||ANCOVA||"Mean difference= GSK249320 1 mg/kg - Placebo.~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 1 mg/kg, Visit 6||2.63|-3.12|
73937008|NCT00833989|147404398|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.55|STANDARD_ERROR_OF_MEAN|1.347|||TWO_SIDED|95.0|-1.2|4.3|||ANCOVA||"Mean difference= GSK249320 5 mg/kg - Placebo~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 5 mg/kg, Visit 6||4.30|-1.20|
73937009|NCT00833989|147404398|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|1.486|||TWO_SIDED|95.0|-3.09|2.98|||ANCOVA||"Mean difference= GSK249320 15 mg/kg - Placebo.~Day 90 GDS Score= Treatment+Day 5 GDS Score"|Placebo Vs GSK249320 15 mg/kg, Visit 6||2.98|-3.09|
73937010|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.289|STANDARD_ERROR_OF_MEAN|0.2639|||TWO_SIDED|95.0|-0.841|0.264|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline|Stimulation Level 100%, Visit 4 Day 30||0.264|-0.841|
73937011|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.2637|||TWO_SIDED|95.0|-0.862|0.241|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30||0.241|-0.862|
73937012|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.303|STANDARD_ERROR_OF_MEAN|0.3172|||TWO_SIDED|95.0|-0.966|0.361|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30||0.361|-0.966|
73937013|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1841|||TWO_SIDED|95.0|-0.184|0.593|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.593|-0.184|
73937014|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.105|STANDARD_ERROR_OF_MEAN|0.1846|||TWO_SIDED|95.0|-0.284|0.494|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.494|-0.284|
73937015|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.416|STANDARD_ERROR_OF_MEAN|0.2602|||TWO_SIDED|95.0|-0.132|0.965|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.965|-0.132|
73937016|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.156|STANDARD_ERROR_OF_MEAN|0.8652|||TWO_SIDED|95.0|-0.65|2.961|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||2.961|-0.650|
73937017|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.518|STANDARD_ERROR_OF_MEAN|0.8324|||TWO_SIDED|95.0|-2.249|1.213|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||1.213|-2.249|
73937018|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.269|STANDARD_ERROR_OF_MEAN|1.0383|||TWO_SIDED|95.0|-2.436|1.898|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||1.898|-2.436|
73937019|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.806|STANDARD_ERROR_OF_MEAN|0.5862|||TWO_SIDED|95.0|-0.42|2.031|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112||2.031|-0.420|
73937020|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.007|STANDARD_ERROR_OF_MEAN|0.564|||TWO_SIDED|95.0|-1.183|1.168|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit"|Stimulation Level 110%, Visit 7 Day 112||1.168|-1.183|
73937021|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.506|STANDARD_ERROR_OF_MEAN|0.757|||TWO_SIDED|95.0|-0.064|3.077|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112||3.077|-0.064|
73937022|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.644|STANDARD_ERROR_OF_MEAN|1.2976|||TWO_SIDED|95.0|-1.056|4.344|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||4.344|-1.056|
73937023|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231|STANDARD_ERROR_OF_MEAN|1.1762|||TWO_SIDED|95.0|-2.681|2.219|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||2.219|-2.681|
73937024|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.184|STANDARD_ERROR_OF_MEAN|1.4796|||TWO_SIDED|95.0|-3.279|2.91|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||2.910|-3.279|
73937025|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.622|STANDARD_ERROR_OF_MEAN|0.9746|||TWO_SIDED|95.0|-1.428|2.672|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||2.672|-1.428|
73937026|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.602|STANDARD_ERROR_OF_MEAN|0.934|||TWO_SIDED|95.0|-2.56|1.356|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||1.356|-2.560|
73937027|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.063|STANDARD_ERROR_OF_MEAN|1.281|||TWO_SIDED|95.0|-0.61|4.736|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||4.736|-0.610|
73937028|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.556|STANDARD_ERROR_OF_MEAN|1.4588|||TWO_SIDED|95.0|-1.494|4.607|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||4.607|-1.494|
73937029|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.531|STANDARD_ERROR_OF_MEAN|1.2336|||TWO_SIDED|95.0|-3.102|2.041|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||2.041|-3.102|
73937030|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.185|STANDARD_ERROR_OF_MEAN|1.5697|||TWO_SIDED|95.0|-3.471|3.101|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||3.101|-3.471|
73937031|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.686|STANDARD_ERROR_OF_MEAN|1.2689|||TWO_SIDED|95.0|-1.996|3.367|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||3.367|-1.996|
73937032|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.556|STANDARD_ERROR_OF_MEAN|1.0822|||TWO_SIDED|95.0|-2.838|1.726|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||1.726|-2.838|
73937033|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.219|STANDARD_ERROR_OF_MEAN|1.4792|||TWO_SIDED|95.0|-0.884|5.322|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||5.322|-0.884|
73937034|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.631|STANDARD_ERROR_OF_MEAN|1.589|||TWO_SIDED|95.0|-1.696|4.958|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||4.958|-1.696|
73937035|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.508|STANDARD_ERROR_OF_MEAN|1.2985|||TWO_SIDED|95.0|-3.219|2.203|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||2.203|-3.219|
73937036|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|1.6603|||TWO_SIDED|95.0|-3.369|3.588|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||3.588|-3.369|
73937037|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.852|STANDARD_ERROR_OF_MEAN|1.5675|||TWO_SIDED|95.0|-2.446|4.15|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||4.150|-2.446|
73937038|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.357|STANDARD_ERROR_OF_MEAN|1.2918|||TWO_SIDED|95.0|-3.074|2.359|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||2.359|-3.074|
73937039|NCT00833989|147404399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.686|STANDARD_ERROR_OF_MEAN|1.7306|||TWO_SIDED|95.0|-1.937|5.308|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||5.308|-1.937|
73937040|NCT01949480|147404401|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.643|||||||t-test, 2 sided|||||||0.643
73937041|NCT01949480|147404403|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.077|||||||t-test, 2 sided|||This p-value is calculated for the NRS at rest.||||.077
73937042|NCT01949480|147404403|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.39|||||||t-test, 2 sided|||This p-value is calculated for the NRS during deep inspiration at 24 hrs.||||0.39
73937043|NCT01949480|147404404|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.605|||||||t-test, 2 sided|||||||0.605
74088936|NCT00842530|147731138|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|33.4|||||TWO_SIDED|95.0|4.1|53.5||||||Vaccine efficacy: 28 days Post-Inj. 1 up to end of Active Phase||53.5|4.1|
73937044|NCT01949480|147404405|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.104|||||||t-test, 2 sided|||This p-value is for the Local Anesthetic infused in 24 hrs.||||0.104
73937045|NCT01949480|147404406|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.308|||||||t-test, 2 sided|||||||0.308
73937046|NCT01949480|147404407|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.487|||||||t-test, 2 sided|||||||0.487
73937047|NCT01949480|147404408|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.493|||||||t-test, 2 sided|||||||0.493
73937048|NCT01949480|147404409|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.574|||||||t-test, 2 sided|||||||0.574
73937049|NCT01949480|147404410|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.913|||||||t-test, 2 sided|||||||0.913
73937050|NCT01949480|147404411|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.783|||||||t-test, 2 sided|||||||0.783
73937051|NCT00144339|147404413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.0||0.9524||95.0|-4.0|4.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||4|-4|0.9524
73937052|NCT00144339|147404414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.2074||95.0|-2.0|6.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||6|-2|0.2074
73937053|NCT00144339|147404415|SUPERIORITY_OR_OTHER|||||||0.2488||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.2488
73937054|NCT00144339|147404416|SUPERIORITY_OR_OTHER|||||||0.0145||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.0145
73937055|NCT00144339|147404417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|4.0||0.299||95.0|-12.0|4.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||4|-12|0.2990
73937056|NCT00144339|147404418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.0||0.8375||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||7|-9|0.8375
73937057|NCT00144339|147404419|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|4.0||0.1143||95.0|-14.0|2.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||2|-14|0.1143
73937058|NCT00144339|147404420|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.0||0.787||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||7|-9|0.7870
73937059|NCT00144339|147404421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.784||95.0|-0.2|0.3|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||0.3|-0.2|0.7840
73937060|NCT00144339|147404422|SUPERIORITY_OR_OTHER|||||||0.2705||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.2705
73937061|NCT00144339|147404423|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.306
73937062|NCT00144339|147404424|SUPERIORITY_OR_OTHER|||||||0.8103||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.8103
73937063|NCT00144339|147404425|SUPERIORITY_OR_OTHER|||||||0.9814||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.9814
73937064|NCT00144339|147404426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.81|0.91|||Log Rank|Cox regression with treatment|Median estimated by Kaplan-Meier estimates; hazard ratio shown as tio vs. placebo|Cox regression||0.91|0.81|<0.0001
73937065|NCT00144339|147404427|SUPERIORITY_OR_OTHER||Rate Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.81|0.91|||t-test, 2 sided||Ratio calculated as estimated number of events in tio/number of events in placebo|Poisson regression adjusted for overdispersion and treatment exposure||0.91|0.81|<0.0001
73937066|NCT00144339|147404428|SUPERIORITY_OR_OTHER|||||||0.3481||95.0|||||Fisher Exact|||||||0.3481
73937067|NCT00144339|147404429|SUPERIORITY_OR_OTHER||Rate Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.03||0.0011||95.0|0.83|0.95|||t-test, 2 sided||Poisson regression adjusting for overdispersion with Pearson's method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.|Poisson regression adjusted for overdispersion and treatment exposure||0.95|0.83|0.0011
73937068|NCT00144339|147404430|SUPERIORITY_OR_OTHER|||||||0.1766||95.0|||||Fisher Exact|||||||0.1766
73937069|NCT00144339|147404431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.04||0.0024||95.0|0.78|0.95|||Log Rank||Hazard ratio shown as tiotropium bromide vs. placebo|Cox regression||0.95|0.78|0.0024
73937070|NCT00144339|147404432|SUPERIORITY_OR_OTHER||Rate ratio|0.94|STANDARD_ERROR_OF_MEAN|0.06||0.3413||95.0|0.82|1.07|||t-test, 2 sided||Ratio of estimated number of events between tiotropium bromide and placebo|||1.07|0.82|0.3413
73937071|NCT00144339|147404433|SUPERIORITY_OR_OTHER||Rate ratio|1.01||||0.8624||95.0|0.87|1.18|||t-test, 2 sided||Ratio of estimated number of days of chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization between tio and placebo|Poisson regression adjusting for overdispersion with Pearson's method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.||1.18|0.87|0.8624
73937072|NCT00144339|147404434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|||<|0.0001||95.0|0.077|0.098|||ANOVA|Repeated measures ANOVA||||0.098|0.077|<.0001
73937073|NCT00144339|147404435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|||<|0.0001||95.0|0.037|0.057|||ANOVA|Repeated measures ANOVA||||0.057|0.037|<.0001
73937074|NCT00144339|147404436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.087|0.11|||ANOVA|Repeated measures ANOVA||||0.110|0.087|<.0001
74030622|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.529||||0.0083|TWO_SIDED|95.0|1.116|2.097|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.097|1.116|0.0083
74030623|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.285||||0.0028|TWO_SIDED|95.0|1.09|1.515|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.515|1.090|0.0028
74030624|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.061||||0.0002|TWO_SIDED|95.0|1.401|3.032|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.032|1.401|0.0002
74030625|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.327||||0.0019|TWO_SIDED|95.0|0.162|0.662|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.662|0.162|0.0019
74030626|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.0086|TWO_SIDED|95.0|0.137|0.749|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.749|0.137|0.0086
74030627|NCT01070550|147615310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.247|||<|0.0001|TWO_SIDED|95.0|0.138|0.441|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.441|0.138|<0.0001
74030628|NCT00109733|147615326|SUPERIORITY_OR_OTHER|||||||0.177|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.177
74030629|NCT00109733|147615326|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.004
73937075|NCT00144339|147404437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|||<|0.0001||95.0|0.047|0.069|||ANOVA|Repeated measures ANOVA||||0.069|0.047|<.0001
73937076|NCT00144339|147404438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|||<|0.0001||95.0|0.091|0.115|||ANOVA|Repeated measures ANOVA||||0.115|0.091|<.0001
73937077|NCT00144339|147404439|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.054|||<|0.0001||95.0|0.042|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.042|<.0001
73937078|NCT00144339|147404440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|||<|0.0001||95.0|0.078|0.104|||ANOVA|Repeated measures ANOVA||||0.104|0.078|<.0001
73937079|NCT00144339|147404441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|||<|0.0001||95.0|0.04|0.066|||ANOVA|Repeated measures ANOVA||||0.066|0.040|<.0001
73937080|NCT00144339|147404442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|||<|0.0001||95.0|0.081|0.107|||ANOVA|Repeated measures ANOVA||||0.107|0.081|<.0001
73937081|NCT00144339|147404443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|||<|0.0001||95.0|0.049|0.075|||ANOVA|Repeated measures ANOVA||||0.075|0.049|<.0001
73937082|NCT00144339|147404444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.081|0.109|||ANOVA|Repeated measures ANOVA||||0.109|0.081|<.0001
73937083|NCT00144339|147404445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.047|0.075|||ANOVA|Repeated measures ANOVA||||0.075|0.047|<.0001
73937084|NCT00144339|147404446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.085|0.114|||ANOVA|Repeated measures ANOVA||||0.114|0.085|<.0001
73937085|NCT00144339|147404447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.051|0.08|||ANOVA|Repeated measures ANOVA||||0.080|0.051|<.0001
73937086|NCT00144339|147404448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.08|0.11|||ANOVA|Repeated measures ANOVA||||0.110|0.080|<.0001
73937087|NCT00144339|147404449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.045|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.045|<.0001
73937088|NCT00144339|147404450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|||<|0.0001||95.0|0.073|0.103|||ANOVA|Repeated measures ANOVA||||0.103|0.073|<.0001
73937089|NCT00144339|147404451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|||<|0.0001||95.0|0.033|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.033|<.0001
73937090|NCT00144339|147404452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.0001||95.0|0.168|0.211|||ANOVA|Repeated measures ANOVA||||0.211|0.168|<.0001
73937091|NCT00144339|147404453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.037|0.073|||ANOVA|Repeated measures ANOVA||||0.073|0.037|<.0001
73937092|NCT00144339|147404454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|||<|0.0001||95.0|0.18|0.228|||ANOVA|Repeated measures ANOVA||||0.228|0.180|<.0001
73937093|NCT00144339|147404455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.034|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.034|<.0001
73937094|NCT00144339|147404456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|||<|0.0001||95.0|0.173|0.222|||ANOVA|Repeated measures ANOVA||||0.222|0.173|<.0001
73937095|NCT00144339|147404457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||<|0.0001||95.0|0.026|0.07|||ANOVA|Repeated measures ANOVA||||0.070|0.026|<.0001
73937096|NCT00144339|147404458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|||<|0.0001||95.0|0.167|0.221|||ANOVA|Repeated measures ANOVA||||0.221|0.167|<.0001
73937097|NCT00144339|147404459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||<|0.0001||95.0|0.026|0.074|||ANOVA|Repeated measures ANOVA||||0.074|0.026|<.0001
73937098|NCT00144339|147404460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|||<|0.0001||95.0|0.161|0.216|||ANOVA|Repeated measures ANOVA||||0.216|0.161|<.0001
73937099|NCT00144339|147404461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|||<|0.0001||95.0|0.035|0.084|||ANOVA|Repeated measures ANOVA||||0.084|0.035|<.0001
73937100|NCT00144339|147404462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|||<|0.0001||95.0|0.157|0.213|||ANOVA|Repeated measures ANOVA||||0.213|0.157|<.0001
73937101|NCT00144339|147404463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047||||0.0005||95.0|0.021|0.074|||ANOVA|Repeated measures ANOVA||||0.074|0.021|0.0005
73937102|NCT00144339|147404464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.0001||95.0|0.17|0.229|||ANOVA|Repeated measures ANOVA||||0.229|0.170|<.0001
73937103|NCT00144339|147404465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.038|0.093|||ANOVA|Repeated measures ANOVA||||0.093|0.038|<.0001
73937104|NCT00144339|147404466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|||<|0.0001||95.0|0.154|0.215|||ANOVA|Repeated measures ANOVA||||0.215|0.154|<.0001
73937105|NCT00144339|147404467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046||||0.002||95.0|0.017|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.017|0.0020
73937106|NCT00144339|147404468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.139|0.201|||ANOVA|Repeated measures ANOVA||||0.201|0.139|<.0001
73937107|NCT00144339|147404469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0365||95.0|0.002|0.061|||ANOVA|Repeated measures ANOVA||||0.061|0.002|0.0365
73937108|NCT00144339|147404470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.147|0.192|||ANOVA|Repeated measures ANOVA||||0.192|0.147|<.0001
73937109|NCT00144339|147404471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.0002||95.0|0.018|0.058|||ANOVA|Repeated measures ANOVA||||0.058|0.018|0.0002
73937110|NCT00144339|147404472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||<|0.0001||95.0|0.161|0.21|||ANOVA|Repeated measures ANOVA||||0.210|0.161|<.0001
73937111|NCT00144339|147404473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.0018||95.0|0.014|0.06|||ANOVA|Repeated measures ANOVA||||0.060|0.014|0.0018
73937112|NCT00144339|147404474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|||<|0.0001||95.0|0.151|0.201|||ANOVA|Repeated measures ANOVA||||0.201|0.151|<.0001
73937113|NCT00144339|147404475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0069||95.0|0.009|0.055|||ANOVA|Repeated measures ANOVA||||0.055|0.009|0.0069
73937114|NCT00144339|147404476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.127|0.182|||ANOVA|Repeated measures ANOVA||||0.182|0.127|<.0001
73937115|NCT00144339|147404477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.002||95.0|0.015|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.015|0.0020
73937116|NCT00144339|147404478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|||<|0.0001||95.0|0.139|0.194|||ANOVA|Repeated measures ANOVA||||0.194|0.139|<.0001
73937117|NCT00144339|147404479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0165||95.0|0.006|0.057|||ANOVA|Repeated measures ANOVA||||0.057|0.006|0.0165
73937118|NCT00144339|147404480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.141|0.199|||ANOVA|Repeated measures ANOVA||||0.199|0.141|<.0001
73937119|NCT00144339|147404481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.0248||95.0|0.004|0.059|||ANOVA|Repeated measures ANOVA||||0.059|0.004|0.0248
73937120|NCT00144339|147404482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|||<|0.0001||95.0|0.136|0.196|||ANOVA|Repeated measures ANOVA||||0.196|0.136|<.0001
73937121|NCT00144339|147404483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.0004||95.0|0.022|0.078|||ANOVA|Repeated measures ANOVA||||0.078|0.022|0.0004
73937122|NCT00144339|147404484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|||<|0.0001||95.0|0.13|0.192|||ANOVA|Repeated measures ANOVA||||0.192|0.130|<.0001
73937123|NCT00144339|147404485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.0809||95.0|-0.003|0.057|||ANOVA|Repeated measures ANOVA||||0.057|-0.003|0.0809
73937124|NCT00144339|147404486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.0001||95.0|0.119|0.182|||ANOVA|Repeated measures ANOVA||||0.182|0.119|<.0001
73937125|NCT00144339|147404487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.0915||95.0|-0.004|0.057|||ANOVA|Repeated measures ANOVA||||0.057|-0.004|0.0915
73937126|NCT00144339|147404488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88|||<|0.0001||95.0|-3.535|-2.226|||ANOVA|Repeated measures ANOVA||||-2.226|-3.535|<.0001
73937127|NCT00144339|147404489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.771|||<|0.0001||95.0|-3.461|-2.081|||ANOVA|Repeated measures ANOVA||||-2.081|-3.461|<.0001
73937128|NCT00144339|147404490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.593|||<|0.0001||95.0|-3.352|-1.834|||ANOVA|Repeated measures ANOVA||||-1.834|-3.352|<.0001
73937129|NCT00144339|147404491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.384|||<|0.0001||95.0|-3.191|-1.576|||ANOVA|Repeated measures ANOVA||||-1.576|-3.191|<.0001
73937130|NCT00144339|147404492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.423|||<|0.0001||95.0|-3.277|-1.569|||ANOVA|Repeated measures ANOVA||||-1.569|-3.277|<.0001
73937131|NCT00144339|147404493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.345|||<|0.0001||95.0|-4.229|-2.462|||ANOVA|Repeated measures ANOVA||||-2.462|-4.229|<.0001
73937132|NCT00144339|147404494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.818|||<|0.0001||95.0|-3.742|-1.894|||ANOVA|Repeated measures ANOVA||||-1.894|-3.742|<.0001
73937133|NCT00144339|147404495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.303|||<|0.0001||95.0|-3.266|-1.34|||ANOVA|Repeated measures ANOVA||||-1.340|-3.266|<.0001
73937134|NCT00144339|147404496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|STANDARD_ERROR_OF_MEAN|0.06||0.0242||95.0|0.74|0.98|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo|||0.98|0.74|0.0242
73937135|NCT00144339|147404497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|STANDARD_ERROR_OF_MEAN|0.06||0.0339||95.0|0.76|0.99|||Log Rank||Cox regression; cut-off at 4 years ; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo|Hazard ratio of all cause mortality vital status was information followed-up after discontinuation; vital status information up to 1440 days after the start of treatment was used||0.99|0.76|0.0339
73937136|NCT00144339|147404498|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|STANDARD_ERROR_OF_MEAN|0.06||0.0859||95.0|0.79|1.02|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo|||1.02|0.79|0.0859
73937137|NCT00144339|147404499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1936||95.0|0.67|1.08|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo|||1.08|0.67|0.1936
73937138|NCT00144339|147404500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.2377||95.0|0.71|1.09|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tiotropium bromide vs. placebo|||1.09|0.71|0.2377
73937139|NCT00144339|147404501|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.029||95.0|0.73|0.98|||Z-test|incidence rate = number of patients with event/ time at risk|Rate ratio of incidence rates (tiotropium/placebo)|||0.98|0.73|0.0290
73937140|NCT00144339|147404502|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.44||||0.1158||95.0|0.91|2.26|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||2.26|0.91|0.1158
73937141|NCT00144339|147404503|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.95||||0.7725||95.0|0.68|1.33|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.33|0.68|0.7725
73937142|NCT00144339|147404504|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.25||||0.2666||95.0|0.84|1.87|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.87|0.84|0.2666
73937143|NCT00144339|147404505|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.59||||0.0337||95.0|0.37|0.96|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.96|0.37|0.0337
73937144|NCT00144339|147404506|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.58||||0.0537||95.0|0.33|1.01|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.01|0.33|0.0537
73937145|NCT00144339|147404507|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.71||||0.0403||95.0|0.52|0.99|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.99|0.52|0.0403
73937146|NCT00144339|147404508|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.0001||95.0|0.77|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.92|0.77|0.0001
73937147|NCT00144339|147404509|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.2||||0.4789||95.0|0.73|1.98|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.98|0.73|0.4789
73937148|NCT00144339|147404510|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.0014||95.0|0.76|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.94|0.76|0.0014
73937149|NCT00144339|147404511|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.61||||0.0236||95.0|0.4|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.94|0.40|0.0236
73937150|NCT00144339|147404512|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.95||||0.5064||95.0|0.81|1.11|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.11|0.81|0.5064
73937151|NCT00144339|147404513|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.69||||0.0104||95.0|0.52|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.92|0.52|0.0104
73937152|NCT00690755|147404518|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||.001
73937153|NCT03825380|147404563|NON_INFERIORITY|"Primary tested:Non-inferiority of T4032 to Lumigan® on the change from baseline in IOP using a MMRM. 3 independent models will be performed, one for each time point (8:00, 10:00~\& 16:00). The 95% CI for treatment effect (difference T4032 - Lumigan) will be estimated at Wk 12. NI will be achieved if the upper bound of the 95% CI for the difference between treatment groups (T4032 - Lumigan) is lower than the margin of +1.5 mmHg for each of the 3 time points 8:00, 10:00 \& 16:00."|Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.23||0.453|TWO_SIDED|95.0|-0.62|0.28|||Mixed Models Analysis|||||0.28|-0.62|0.453
73937154|NCT04773015|147404574|OTHER|||||||0.6371|||||||Fisher Exact|||||||0.6371
73937155|NCT04773015|147404575|OTHER|||||||0.1448|||||||Fisher Exact|||||||0.1448
73937156|NCT04773015|147404576|OTHER|||||||0.1507|||||||Fisher Exact|||||||0.1507
73937157|NCT04773015|147404577|OTHER|||||||0.1189|||||||Fisher Exact|||||||0.1189
73937158|NCT00839072|147404632|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax does not exceed 125%.|Ratio of the mean|59.66|||||TWO_SIDED|90.0|50.99|69.81|||||Trazodone Contramid® OAD/Desyrel®|||69.81|50.99|
73937159|NCT00839072|147404633|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCT is between 80% and 125%.|Ratio of the mean|78.55|||||TWO_SIDED|90.0|69.7|88.51|||||Trazodone Contramid® OAD/Desyrel®|||88.51|69.70|
73937160|NCT00839072|147404634|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC∞ is between 80% and 125%.|Ratio of the mean|80.05|||||TWO_SIDED|90.0|70.67|90.68|||||Trazodone Contramid® OAD/Desyrel®|||90.68|70.67|
73937161|NCT01458574|147404638|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95 percent (%) confidence interval (CI) based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).||31.2|15.3|<0.0001
73937162|NCT01458574|147404638|SUPERIORITY_OR_OTHER||Difference in percentage|29.5|||<|0.0001|TWO_SIDED|95.0|21.4|37.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||37.6|21.4|<0.0001
73937163|NCT01458574|147404639|SUPERIORITY_OR_OTHER||Difference in percentage|24.2|||<|0.0001|TWO_SIDED|95.0|16.0|32.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.5|16.0|<0.0001
73937164|NCT01458574|147404639|SUPERIORITY_OR_OTHER||Difference in percentage|32.6|||<|0.0001|TWO_SIDED|95.0|24.2|41.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||41.0|24.2|<0.0001
73937165|NCT01458574|147404640|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001|TWO_SIDED|95.0|17.4|43.2|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||43.2|17.4|<0.0001
73937166|NCT01458574|147404640|SUPERIORITY_OR_OTHER||Difference in percentage|42.2|||<|0.0001|TWO_SIDED|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||56.5|27.9|<0.0001
73937167|NCT01458574|147404641|SUPERIORITY_OR_OTHER||Difference in percentage|22.7|||<|0.0001|TWO_SIDED|95.0|14.8|30.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||30.6|14.8|<0.0001
73937168|NCT01458574|147404641|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|16.4|32.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.4|16.4|<0.0001
74030630|NCT00109733|147615327|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.004
73937169|NCT01458574|147404642|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.7|10.6|<0.0001
73937170|NCT01458574|147404642|SUPERIORITY_OR_OTHER||Difference in percentage|20.3|||<|0.0001|TWO_SIDED|95.0|13.5|27.1|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.1|13.5|<0.0001
73937171|NCT01458574|147404643|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||<|0.0001|TWO_SIDED|95.0|18.1|35.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||35.5|18.1|<0.0001
73937172|NCT01458574|147404643|SUPERIORITY_OR_OTHER||Difference in percentage|29.0|||<|0.0001|TWO_SIDED|95.0|20.3|37.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||37.7|20.3|<0.0001
73937173|NCT01458574|147404644|SUPERIORITY_OR_OTHER||Difference in percentage|21.2|||<|0.0001|TWO_SIDED|95.0|14.1|28.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||28.3|14.1|<0.0001
73937174|NCT01458574|147404644|SUPERIORITY_OR_OTHER||Difference in percentage|26.4|||<|0.0001|TWO_SIDED|95.0|19.0|33.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||33.8|19.0|<0.0001
73937175|NCT01458574|147404645|SUPERIORITY_OR_OTHER||Difference in percentage|30.6|||<|0.0001|TWO_SIDED|95.0|18.1|43.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||43.1|18.1|<0.0001
73937176|NCT01458574|147404645|SUPERIORITY_OR_OTHER||Difference in percentage|44.5|||<|0.0001|TWO_SIDED|95.0|31.8|57.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||57.2|31.8|<0.0001
73937177|NCT01458574|147404645|SUPERIORITY_OR_OTHER||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|18.7|41.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||41.4|18.7|<0.0001
73937178|NCT01458574|147404645|SUPERIORITY_OR_OTHER||Difference in percentage|43.2|||<|0.0001|TWO_SIDED|95.0|31.1|55.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||55.3|31.1|<0.0001
73937179|NCT01458574|147404646|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|13.8|35.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||35.0|13.8|<0.0001
73937180|NCT01458574|147404646|SUPERIORITY_OR_OTHER||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|28.7|52.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||52.3|28.7|<0.0001
73937181|NCT01458574|147404647|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001|TWO_SIDED|95.0|20.9|39.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||39.7|20.9|<0.0001
73937182|NCT01458574|147404647|SUPERIORITY_OR_OTHER||Difference in percentage|37.2|||<|0.0001|TWO_SIDED|95.0|28.1|46.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||46.4|28.1|<0.0001
73937183|NCT01458574|147404647|SUPERIORITY_OR_OTHER||Difference in percentage|31.3|||<|0.0001|TWO_SIDED|95.0|22.4|40.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||40.2|22.4|<0.0001
74030631|NCT00109733|147615327|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||<0.001
73937184|NCT01458574|147404647|SUPERIORITY_OR_OTHER||Difference in percentage|41.7|||<|0.0001|TWO_SIDED|95.0|32.9|50.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||50.5|32.9|<0.0001
73937185|NCT01458574|147404648|SUPERIORITY_OR_OTHER||Difference in percentage|29.8|||<|0.0001|TWO_SIDED|95.0|20.9|38.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||38.7|20.9|<0.0001
73937186|NCT01458574|147404648|SUPERIORITY_OR_OTHER||Difference in percentage|40.2|||<|0.0001|TWO_SIDED|95.0|31.4|49.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||49.0|31.4|<0.0001
73937187|NCT01458574|147404649|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||31.2|15.3|<0.0001
73937188|NCT01458574|147404649|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|16.4|32.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.4|16.4|<0.0001
73937189|NCT01458574|147404649|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||31.2|15.3|<0.0001
73937190|NCT01458574|147404649|SUPERIORITY_OR_OTHER||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|21.9|38.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||38.2|21.9|<0.0001
73937191|NCT01458574|147404650|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.7|10.6|<0.0001
73937192|NCT01458574|147404650|SUPERIORITY_OR_OTHER||Difference in percentage|20.8|||<|0.0001|TWO_SIDED|95.0|14.0|27.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.7|14.0|<0.0001
73937193|NCT01458574|147404651|SUPERIORITY_OR_OTHER||Difference in percentage|10.1||||0.0006|TWO_SIDED|95.0|4.5|15.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||15.7|4.5|0.0006
73937194|NCT01458574|147404651|SUPERIORITY_OR_OTHER||Difference in percentage|6.6||||0.0092|TWO_SIDED|95.0|1.5|11.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||11.7|1.5|0.0092
73937195|NCT01458574|147404651|SUPERIORITY_OR_OTHER||Difference in percentage|10.6||||0.0004|TWO_SIDED|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.2|5.0|0.0004
73937196|NCT01458574|147404651|SUPERIORITY_OR_OTHER||Difference in percentage|11.2|||<|0.0001|TWO_SIDED|95.0|5.5|16.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.9|5.5|<0.0001
73937197|NCT01458574|147404652|SUPERIORITY_OR_OTHER||Difference in percentage|5.6||||0.0029|TWO_SIDED|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||9.0|2.1|0.0029
73937198|NCT01458574|147404652|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.035|TWO_SIDED|95.0|0.3|5.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||5.8|0.3|0.0350
73937199|NCT01458574|147404653|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.3|24.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.0|10.3|<0.0001
73973331|NCT06946888|147489448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.251||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.251
74008351|NCT03627767|147566504|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.255|0.516||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.516|0.255|< 0.0001
74008352|NCT03627767|147566505|SUPERIORITY||LSM difference|0.1|||=|0.7556|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.4|= 0.7556
73937200|NCT01458574|147404653|SUPERIORITY_OR_OTHER||Difference in percentage|15.3|||<|0.0001|TWO_SIDED|95.0|8.5|22.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||22.0|8.5|<0.0001
73937201|NCT01458574|147404653|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||<|0.0001|TWO_SIDED|95.0|8.8|22.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||22.5|8.8|<0.0001
73937202|NCT01458574|147404653|SUPERIORITY_OR_OTHER||Difference in percentage|19.8|||<|0.0001|TWO_SIDED|95.0|12.7|27.0|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.0|12.7|<0.0001
73937203|NCT01458574|147404654|SUPERIORITY_OR_OTHER||Difference in percentage|11.1|||<|0.0001|TWO_SIDED|95.0|5.9|16.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.4|5.9|<0.0001
73937204|NCT01458574|147404654|SUPERIORITY_OR_OTHER||Difference in percentage|13.2|||<|0.0001|TWO_SIDED|95.0|7.7|18.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.7|7.7|<0.0001
73937205|NCT01458574|147404655|SUPERIORITY_OR_OTHER||Difference in percentage|12.1|||<|0.0001|TWO_SIDED|95.0|6.3|17.9|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||17.9|6.3|<0.0001
73937206|NCT01458574|147404655|SUPERIORITY_OR_OTHER||Difference in percentage|8.1||||0.0021|TWO_SIDED|95.0|2.8|13.5|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||13.5|2.8|0.0021
73937207|NCT01458574|147404655|SUPERIORITY_OR_OTHER||Difference in percentage|10.6||||0.0004|TWO_SIDED|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.2|5.0|0.0004
73937208|NCT01458574|147404655|SUPERIORITY_OR_OTHER||Difference in percentage|12.7|||<|0.0001|TWO_SIDED|95.0|6.8|18.6|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.6|6.8|<0.0001
73937209|NCT01458574|147404656|SUPERIORITY_OR_OTHER||Difference in percentage|5.6||||0.0029|TWO_SIDED|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||9.0|2.1|0.0029
73937210|NCT01458574|147404656|SUPERIORITY_OR_OTHER||Difference in percentage|4.6||||0.0064|TWO_SIDED|95.0|1.4|7.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||7.8|1.4|0.0064
73937211|NCT01458574|147404658|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.9|||Linear mixed effect model|||At Week 24||-1.9|-3.2|<0.0001
73937212|NCT01458574|147404658|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.8|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.2|||Linear mixed effect model|||At Week 24||-2.2|-3.5|<0.0001
73937213|NCT01458574|147404658|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.7|||Linear mixed effect model|||At Week 52||-1.7|-3.4|<0.0001
73937214|NCT01458574|147404658|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.1|-2.5|||Linear mixed effect model|||At Week 52||-2.5|-4.1|<0.0001
73937215|NCT01458574|147404659|SUPERIORITY_OR_OTHER||Difference in percentage|40.1|||<|0.0001|TWO_SIDED|95.0|25.0|55.3|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||55.3|25.0|<0.0001
73937216|NCT01458574|147404659|SUPERIORITY_OR_OTHER||Difference in percentage|48.4|||<|0.0001|TWO_SIDED|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||64.1|32.7|<0.0001
73937217|NCT01458574|147404659|SUPERIORITY_OR_OTHER||Difference in percentage|36.0|||<|0.0001|TWO_SIDED|95.0|21.6|50.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||50.3|21.6|<0.0001
73937218|NCT01458574|147404659|SUPERIORITY_OR_OTHER||Difference in percentage|46.2|||<|0.0001|TWO_SIDED|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||61.4|31.0|<0.0001
73937219|NCT01458574|147404660|SUPERIORITY_OR_OTHER||Difference in percentage|31.8|||<|0.0001|TWO_SIDED|95.0|18.8|44.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||44.8|18.8|<0.0001
73937220|NCT01458574|147404660|SUPERIORITY_OR_OTHER||Difference in percentage|42.2|||<|0.0001|TWO_SIDED|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||56.5|27.9|<0.0001
73937221|NCT01458574|147404661|SUPERIORITY_OR_OTHER||Difference in percentage|38.6|||<|0.0001|TWO_SIDED|95.0|23.4|53.8|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||53.8|23.4|<0.0001
73937222|NCT01458574|147404661|SUPERIORITY_OR_OTHER||Difference in percentage|48.4|||<|0.0001|TWO_SIDED|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||64.1|32.7|<0.0001
73937223|NCT01458574|147404661|SUPERIORITY_OR_OTHER||Difference in percentage|34.4|||<|0.0001|TWO_SIDED|95.0|20.1|48.8|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||48.8|20.1|<0.0001
73937224|NCT01458574|147404661|SUPERIORITY_OR_OTHER||Difference in percentage|46.2|||<|0.0001|TWO_SIDED|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||61.4|31.0|<0.0001
73937225|NCT01458574|147404662|SUPERIORITY_OR_OTHER||Difference in percentage|12.9||||0.0074|TWO_SIDED|95.0|2.6|23.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.2|2.6|0.0074
73937226|NCT01458574|147404662|SUPERIORITY_OR_OTHER||Difference in percentage|13.2||||0.0103|TWO_SIDED|95.0|2.4|24.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.1|2.4|0.0103
73937227|NCT01458574|147404662|SUPERIORITY_OR_OTHER||Difference in percentage|16.8||||0.0018|TWO_SIDED|95.0|6.2|27.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.5|6.2|0.0018
73937228|NCT01458574|147404662|SUPERIORITY_OR_OTHER||Difference in percentage|16.7||||0.0029|TWO_SIDED|95.0|5.5|27.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.9|5.5|0.0029
73937229|NCT01458574|147404663|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.0419|TWO_SIDED|95.0|0.1|15.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||15.7|0.1|0.0419
73937230|NCT01458574|147404663|SUPERIORITY_OR_OTHER||Difference in percentage|11.1||||0.0121|TWO_SIDED|95.0|2.3|19.9|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||19.9|2.3|0.0121
73937231|NCT01682837|147404697|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||0.07
73937232|NCT01682837|147404698|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||0.20
73937233|NCT01682837|147404699|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|||||||0.16
73937234|NCT01682837|147404700|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|||||||0.70
73937235|NCT01682837|147404701|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Models Analysis|||||||0.42
73937236|NCT01682837|147404702|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mixed Models Analysis|||||||0.10
73937237|NCT01682837|147404703|SUPERIORITY_OR_OTHER|||||||0.64|||||||Mixed Models Analysis|||||||0.64
73937238|NCT01682837|147404704|SUPERIORITY_OR_OTHER|||||||0.18|||||||Mixed Models Analysis|||||||0.18
73937239|NCT01682837|147404705|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mixed Models Analysis|||||||0.12
73937240|NCT02877485|147404724|OTHER||Mean Difference (Net)|1.5||||0.7|TWO_SIDED|95.0|-6.0|8.9||"Statistical Tests:~Independent t-test to assess differences in mean change in NOSE scores when comparing the two study groups, and p\<0.05 deemed statistically significant"|t-test, 2 sided||Change in Mean NOSE score from baseline to post saline versus change in NOSE score from baseline to post intranasal steroid.|"1\) H0: mean change in NOSE score from baseline after in study group 1 = mean change in NOSE score from baseline in study group 2~Power calculation: To detect a 20% difference in NOSE scores with 80% power and a 2-sided alpha level of 0.05 required 20 participants per study group, for a total of 40 participants."||8.9|-6.0|0.7
73937241|NCT02877485|147404725|OTHER||Mean Difference (Final Values)|-50.0|STANDARD_DEVIATION|27.6|<|0.001|TWO_SIDED|||||Paired t-tests to assess differences in mean NOSE score when the treatment groups were combined (saline arm+ steroid arm) at five post-operative time intervals compared to the combined preoperative baseline scores. Significance at p\<0.05.|Paired t-test|||H0: Mean pre- treatment baseline patient NOSE score = Mean post- treatment baseline patient NOSE score.||||<0.001
73937242|NCT03086447|147404786|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of monocular VA better than equal to 20/40 with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agresti-Coull||All eyes (100%) in the Test group had acceptable VA throughout the study.|Proportion of eyes with overall acceptable VA assessed throughout the study period (up to 4-week) in the Test group was compared to the historical control acceptable rate of 80%. Lower 95% confidence limit was compared to 0.8.||100|96.5|
73937243|NCT03086447|147404787|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens fit with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agrestic-Coull||All eyes (100%) in the Test group had acceptable lens fit at fitting (visit 1).|Proportion of eyes with acceptable lens fit assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||100.0|96.5|
73866656|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.67|-0.27||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.27|-0.67|
74030632|NCT00109733|147615328|SUPERIORITY_OR_OTHER|||||||0.653|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.653
73937244|NCT03086447|147404788|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens stability with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agrestic-Coull||All eyes (100%) in the Test group had acceptable stability at fitting.|Proportion of eyes with acceptable stability assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||100.0|96.5|
73937245|NCT03086447|147404789|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of absolute rotation with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Least square mean proportion|99.6|||||TWO_SIDED|95.0|97.5|99.9||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Linear mixed model with binomial dist.||Above 80% of eyes in the Test group had acceptable rotation.|Proportion of eyes with acceptable absolute rotation assessed at 15-minute upon insertion (fitting, visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||99.9|97.5|
73937246|NCT03086447|147404790|OTHER|It was deemed that a total of 135 subjects per each study group is sufficient to demonstrate no statistical difference in the CS incidence rate between the Test and Control groups with a minimum of 80% statistical power using the reference incidence rate of 0.005% with a correlation of 0.3 between eyes within subject.|Odds Ratio (OR)|0.29|||||TWO_SIDED|95.0|0.004|1.437||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Bayesian beta-binomial model|A 95% credible interval for the posterior estimate (Test over Control) was used to test no difference between the Test and Control groups.|odds ratio calculated as Test over Control|Proportion of eyes with unacceptable corneal staining (CS) throughout all planned and unplanned visits in the Test group was compared to that in the Control group.||1.437|0.004|
73937247|NCT03086447|147404791|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|2.39|||TWO_SIDED|95.0|2.1|11.5|||Linear mixed model|A 95% confidence interval for the least square mean difference was used to demonstrate non-inferiority of the Test relative to the Control groups.|Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.||11.5|2.1|
73937248|NCT03086447|147404792|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|2.04|||TWO_SIDED|95.0|-7.2|0.9|||Linear mixed model|A 95% confidence interval for the least square mean difference was used to demonstrate non-inferiority of the Test relative to the Control groups.|Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.||0.9|-7.2|
73937249|NCT03086447|147404793|NON_INFERIORITY|A non-inferiority margin of 0.5 was used. This margin is based on a 10% difference in the distribution between the Test and Control groups.|Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.98|3.22|||Generalized LMM w/ binomial dist.||Odds ratio of Test over Control was calculated.|Proportion of eyes with optimal VA assessed at fitting in the Test group was compared to the Control group.||3.22|0.98|
73937250|NCT02276482|147404798|OTHER||Difference in percentages|3.6|||||TWO_SIDED|95.0|-6.3|13.5|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||13.5|-6.3|
73937251|NCT02276482|147404799|OTHER||Difference in percentages|3.7|||||TWO_SIDED|95.0|-3.4|10.8|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||10.8|-3.4|
73937252|NCT02276482|147404800|OTHER||Difference in percentages|-4.2|||||TWO_SIDED|95.0|-12.9|4.4|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||4.4|-12.9|
73937253|NCT02276482|147404801|OTHER||Difference in percentages|0.2|||||TWO_SIDED|95.0|-7.4|7.7|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||7.7|-7.4|
73937254|NCT02276482|147404802|OTHER||Difference in percentages|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
73937255|NCT01308580|147404834|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.214|Hazard Ratio (HR)|1.024|||||ONE_SIDED|98.89||1.184|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 20 mg/m\^2 relative to 25 mg/m\^2 dose group was considered non-inferior if the upper bound of 1-sided 98.89% confidence interval of hazard ratio (20 mg/m\^2 versus 25 mg/m\^2) was less than the non-inferiority margin of 1.214.||1.184||
73973332|NCT06946888|147489448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.701||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.701
73973333|NCT06946888|147489448|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.08||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.080
73973334|NCT06946888|147489449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.636||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.636
73973335|NCT06946888|147489449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.909||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.909
74008353|NCT03627767|147566505|SUPERIORITY||LSM difference|0.1|||=|0.7484|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.4|= 0.7484
74008354|NCT03627767|147566505|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.5|-0.5|
73937256|NCT01308580|147404834|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024|||||ONE_SIDED|95.0|0.922||||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 25 mg/m\^2 was considered to be superior to 20 mg/m\^2 dose if the lower bound of 1-sided 95% confidence interval of hazard ratio was greater than 1.|||0.922|
73937257|NCT01308580|147404835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.099|||||TWO_SIDED|95.0|0.974|1.24|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.24|0.974|
73937258|NCT01308580|147404836|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.096|||||TWO_SIDED|95.0|0.902|1.331|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.331|0.902|
73937259|NCT01308580|147404838|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.195|||||TWO_SIDED|95.0|1.025|1.393|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.393|1.025|
73937260|NCT01308580|147404840|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046|||||TWO_SIDED|95.0|0.874|1.251|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio is estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.251|0.874|
73937261|NCT02250612|147404870|SUPERIORITY|||||||0.93|||||||ANCOVA|||||||0.93
73937262|NCT02250612|147404870|SUPERIORITY|||||||0.92|||||||ANCOVA|||||||0.92
73937263|NCT02250612|147404870|SUPERIORITY|||||||0.23|||||||ANCOVA|||||||0.23
73937264|NCT02250612|147404870|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
73937265|NCT02250612|147404870|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||0.25
73937266|NCT02250612|147404870|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
73937267|NCT02250612|147404871|SUPERIORITY|||||||0.94|||||||ANCOVA|||||||0.94
73937268|NCT02250612|147404871|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
73937269|NCT02250612|147404871|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
73937270|NCT02250612|147404871|SUPERIORITY|||||||0.412|||||||ANCOVA|||||||0.412
73937271|NCT02250612|147404871|SUPERIORITY|||||||0.79|||||||ANCOVA|||||||0.79
73937272|NCT02250612|147404871|SUPERIORITY|||||||0.28|||||||ANCOVA|||||||0.28
73937273|NCT01262651|147404881|SUPERIORITY||Median Difference (Final Values)|3.41||||0.0854|TWO_SIDED|95.0|0.0|8.16|||Wilcoxon (Mann-Whitney)|||||8.16|0.00|0.0854
73937274|NCT02349295|147404914|OTHER||Odds Ratio (OR)|4.74|||<|0.001|TWO_SIDED|95.0|2.65|8.48||model includes: treatment, geographic region, and tumor necrosis factor inhibitor (TNFi) experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi).|Regression, Logistic|1\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.||||8.48|2.65|<0.001
73937275|NCT02349295|147404914|OTHER|1\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.|Odds Ratio (OR)|3.79|||<|0.001|TWO_SIDED|95.0|2.12|6.78|||Regression, Logistic|||model includes: treatment, geographic region, and TNFi experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi)||6.78|2.12|<0.001
73937276|NCT01914926|147404981|NON_INFERIORITY_OR_EQUIVALENCE|Chi-Square test||||||0.0001||95.0|||||Chi-squared|||We estimated a sample size of 200 patients assigned in a 1:1 ratio to receive diltiazem and metoprolol would achieve 80% power to detect non-inferiority using a one-sided two sample t-test. The margin of equivalence is -10.||||.0001
73973336|NCT06946888|147489449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.627||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.627
73973337|NCT06946888|147489449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.474||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.474
73866657|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.3|0.15||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.15|-0.30|
73973338|NCT06946888|147489449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.378||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.378
73973339|NCT06946888|147489449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.768||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.768
73973340|NCT06946888|147489449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.909||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.909
74008355|NCT03627767|147566505|SUPERIORITY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.6|< 0.0001
74008356|NCT03627767|147566505|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.9|< 0.0001
74030633|NCT00109733|147615328|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.002
74030634|NCT00109733|147615329|SUPERIORITY_OR_OTHER|||||||0.755|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.755
73973341|NCT06946888|147489449|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.449||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.449
73973342|NCT06946888|147489450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.593||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.593
74008357|NCT03627767|147566505|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.7|0.1||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.7|
74008358|NCT03627767|147566505|SUPERIORITY||LSM difference|-0.6|||=|0.0242|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.2|= 0.0242
74008359|NCT03627767|147566505|SUPERIORITY||LSM difference|-0.9|||=|0.0012|TWO_SIDED|95.0|-1.4|-0.4|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-1.4|= 0.0012
74008360|NCT03627767|147566505|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.6|0.1||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.6|
74008361|NCT03627767|147566505|SUPERIORITY||LSM difference|-0.6|||=|0.124|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-1.3|= 0.1240
74008362|NCT03627767|147566505|SUPERIORITY||LSM difference|-0.9|||=|0.0107|TWO_SIDED|95.0|-1.6|-0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.6|= 0.0107
74008363|NCT03627767|147566505|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.8|0.1||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.8|
74008364|NCT03627767|147566505|SUPERIORITY||LSM difference|-0.4|||=|0.3139|TWO_SIDED|95.0|-1.1|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-1.1|= 0.3139
74008365|NCT03627767|147566505|SUPERIORITY||LSM difference|-0.6|||=|0.0853|TWO_SIDED|95.0|-1.3|0.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.3|= 0.0853
74008366|NCT03627767|147566505|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.7|0.2||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.7|
74008367|NCT03627767|147566506|SUPERIORITY||LSM difference|0.4|||=|0.0674|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.8|0.0|= 0.0674
74008368|NCT03627767|147566506|SUPERIORITY||LSM difference|0.3|||=|0.1437|TWO_SIDED|95.0|-0.1|0.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.1|= 0.1437
74008369|NCT03627767|147566506|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.5|
74008370|NCT03627767|147566506|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.8|< 0.0001
73937277|NCT00434057|147404984|SUPERIORITY_OR_OTHER||Sensitivity to melanoma|98.0||||0.05||95.0|95.1|100.0|||exact mid-P||"Of 127 melanomas, 114 melanomas had a pre-biopsy diagnosis of Melanoma can not be ruled out or Not melanoma, which qualified them for primary endpoint analysis of sensitivity. MelaFind correctly identified 112/114 melanomas."|MelaFind's sensitivity to cutaneous melanoma and 95% confidence intervals were determined.||100|95.1|0.05
73866658|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.63|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.63|
73937278|NCT00434057|147404984|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||Specificty of MelaFind and examining dermatologists on the same set of pigmented skin lesions.||||0.02
73937279|NCT05046795|147405088|SUPERIORITY||Mean Difference (Net)|150.91|STANDARD_ERROR_OF_MEAN|23.727|<|0.0001|TWO_SIDED|95.0|104.145|197.671|||Mixed Models Analysis|||||197.671|104.145|<0.0001
73937280|NCT05046795|147405089|SUPERIORITY||Mean Difference (Net)|144.35|STANDARD_ERROR_OF_MEAN|21.192|<|0.0001|TWO_SIDED|95.0|102.61|186.088|||Mixed Models Analysis|||||186.088|102.610|<0.0001
73937281|NCT05046795|147405090|SUPERIORITY||Mean Difference (Net)|287.75|STANDARD_ERROR_OF_MEAN|38.473|<|0.0001|TWO_SIDED|95.0|211.933|363.57|||Mixed Models Analysis|||||363.570|211.933|<0.0001
73937282|NCT05046795|147405091|SUPERIORITY||Mean Difference (Net)|105.9|STANDARD_ERROR_OF_MEAN|16.89|<|0.0001|TWO_SIDED|95.0|72.6|139.12|||ANCOVA|||||139.12|72.60|<0.0001
73937283|NCT05046795|147405092|SUPERIORITY||Mean Difference (Net)|154.8|STANDARD_ERROR_OF_MEAN|28.37|<|0.0001|TWO_SIDED|95.0|98.86|210.78|||ANCOVA|||||210.78|98.86|<0.0001
73937284|NCT05046795|147405093|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_ERROR_OF_MEAN|1.8||0.0064|TWO_SIDED|95.0|-8.49|-1.4|||ANCOVA|||||-1.40|-8.49|0.0064
73937285|NCT05046795|147405094|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0144|TWO_SIDED|95.0|1.16|3.84|||Regression, Logistic|||||3.84|1.16|0.0144
73937286|NCT04313634|147405143|SUPERIORITY|||||||0.611|||||||Wilcoxon (Mann-Whitney)|||||||0.611
73937287|NCT04313634|147405144|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
73937288|NCT04313634|147405145|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
73937289|NCT04313634|147405146|SUPERIORITY|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
73937290|NCT04313634|147405148|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
73937291|NCT02522715|147405169|OTHER||||||<|0.01|||||||two-sided exact binomial test|||One-sample binomial test with null hypothesis that the percentage of participants with PSA response 1 is equal to 25%.||||<0.01
73937292|NCT03980470|147405178|SUPERIORITY|||||||0.198|||||||ANOVA|||||||0.198
73937293|NCT03980470|147405179|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
73937294|NCT03980470|147405180|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
73937295|NCT03980470|147405181|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73937296|NCT03980470|147405182|OTHER|Bland-Altmann analysis (bias)|Mean Difference (Final Values)|-1.42|||||TWO_SIDED|||||||||||||
73937297|NCT01365494|147405208|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be achieved if the lower limit of the two-sided 95% CI of the post vaccination (day 14) ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.667|Ratio of GMCs-Zagreb and Essen at day 14|1.03|||||TWO_SIDED|95.0|0.89|1.19|||ANOVA|||To demonstrate non-inferiority in immune response of the Zagreb postexposure schedule of Rabipur to that of the conventional Essen postexposure schedule at study day 14||1.19|0.89|
73937298|NCT01365494|147405210|SUPERIORITY_OR_OTHER||Ratio of GMCs-Zagreb and Essen at day 7|0.38|||||TWO_SIDED|95.0|0.3|0.48|||ANOVA|||||0.48|0.3|
73937299|NCT01365494|147405210|SUPERIORITY_OR_OTHER||Ratio of GMCs-Zagreb and Essen at day 42|0.96||||||95.0|0.86|1.07|||ANOVA|||||1.07|0.86|
73937300|NCT01359735|147405212|SUPERIORITY_OR_OTHER|||||||0.263|TWO_SIDED|||||Week 04|Wilcoxon (Mann-Whitney)|||||||0.263
73937301|NCT01359735|147405212|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Week 13|Wilcoxon (Mann-Whitney)|||||||0.500
73937302|NCT01359735|147405213|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Over weeks 1 through 4 or Week 4?|Fisher Exact|||||||0.5
73937303|NCT01359735|147405214|SUPERIORITY_OR_OTHER|||||||0.0594|TWO_SIDED||||||Log Rank|||||||0.0594
74030635|NCT00109733|147615329|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||<0.001
74030636|NCT00109733|147615330|SUPERIORITY_OR_OTHER|||||||0.041|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.041
74088937|NCT00842530|147731138|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|34.9|||||TWO_SIDED|95.0|6.7|54.3||||||Vaccine efficacy: Day 0 up to end of Active Phase||54.3|6.7|
73937304|NCT01359735|147405215|SUPERIORITY_OR_OTHER|||||||0.1354|ONE_SIDED|||||3 Weeks|t-test, 1 sided|||||||0.1354
73937305|NCT01359735|147405215|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||12 Weeks|t-test, 1 sided|||||||0.5000
73937306|NCT01359735|147405216|SUPERIORITY_OR_OTHER|||||||0.0841|TWO_SIDED|||||Week 3 Post-surgery|t-test, 1 sided|||||||0.0841
73937307|NCT01359735|147405216|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED|||||Week 12 Post-surgery|t-test, 1 sided|||||||0.1780
73937308|NCT01462344|147405232|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority comparison was statistically significant if the upper bound of the two-sided 95% CI falls below 2.675, the non-inferiority margin, and the non-inferiority test one-sided p-value \<0.025.|Hazard Ratio (HR)|1.285||||0.006|TWO_SIDED|95.0|0.726|2.272|||Regression, Cox||Estimated for Hazard ratio|||2.272|0.726|0.006
73937309|NCT01462344|147405232|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0019|||||TWO_SIDED|95.0|-0.0024|0.0063|||||Estimated for Absolute risk difference|||0.0063|-0.0024|
73937310|NCT01462344|147405233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.859|||||TWO_SIDED|95.0|0.729|1.012|||||Estimated for Hazard ratio|||1.012|0.729|
73937311|NCT03394924|147405260|SUPERIORITY||Odds Ratio (OR)|5.6||||0.106|TWO_SIDED|95.0|0.6|52.0|||Cochran-Mantel-Haenszel|||||52|0.6|0.106
73937312|NCT03394924|147405260|SUPERIORITY||Odds Ratio (OR)|7.0||||0.063|TWO_SIDED|95.0|0.75|65.22|||Cochran-Mantel-Haenszel|||||65.22|0.75|0.063
74030637|NCT00109733|147615330|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.044
74088938|NCT00486018|147731144|SUPERIORITY_OR_OTHER||Difference in Least Squares means|9.4|||<|0.0001||95.0|6.6|12.2||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||12.2|6.6|<0.0001
74088939|NCT00486018|147731144|SUPERIORITY_OR_OTHER||Difference in Least Squares means|10.6|||<|0.0001||95.0|7.6|13.6||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||13.6|7.6|<0.0001
74088940|NCT00486018|147731145|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||<|0.0001||95.0|15.6|38.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||38.0|15.6|<0.0001
74088941|NCT00486018|147731145|SUPERIORITY_OR_OTHER||Difference in percentage|31.3|||<|0.0001||95.0|20.1|42.6|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||42.6|20.1|<0.0001
74088942|NCT00486018|147731146|SUPERIORITY_OR_OTHER||Difference in percentage|4.5||||0.0141||95.0|1.6|9.9|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.|||9.9|1.6|0.0141
73937313|NCT03394924|147405264|SUPERIORITY||Least squares mean difference|0.47||||0.616|TWO_SIDED|95.0|-1.39|2.32|||ANCOVA|||Analysis for total bilirubin.||2.32|-1.39|0.616
73937314|NCT03394924|147405264|SUPERIORITY||Least squares mean difference|0.19||||0.844|TWO_SIDED|95.0|-1.78|2.16|||ANCOVA|||Analysis for total bilirubin.||2.16|-1.78|0.844
73937315|NCT03394924|147405264|SUPERIORITY||Least squares mean difference|-0.67||||0.18|TWO_SIDED|95.0|-1.67|0.32|||ANCOVA|||Analysis for conjugated bilirubin.||0.32|-1.67|0.18
73937316|NCT03394924|147405264|SUPERIORITY||Least squares mean difference|-0.64||||0.239|TWO_SIDED|95.0|-1.71|0.44|||ANCOVA|||Analysis for conjugated bilirubin.||0.44|-1.71|0.239
73937317|NCT03394924|147405264|SUPERIORITY||Least squares mean difference|1.21||||0.116|TWO_SIDED|95.0|-0.31|2.73|||ANCOVA|||Analysis for unconjugated bilirubin.||2.73|-0.31|0.116
73937318|NCT03394924|147405264|SUPERIORITY||Least squares mean difference|0.72||||0.36|TWO_SIDED|95.0|-0.84|2.28|||ANCOVA|||Analysis for unconjugated bilirubin.||2.28|-0.84|0.36
73937319|NCT03394924|147405265|SUPERIORITY||Least squares mean difference|-25.55||||0.001|TWO_SIDED|95.0|-40.07|-11.04|||ANCOVA|||Analysis for ALT.||-11.04|-40.07|0.001
73937320|NCT03394924|147405265|SUPERIORITY||Least squares mean difference|-21.35||||0.009|TWO_SIDED|95.0|-37.1|-5.6|||ANCOVA|||Analysis for ALT.||-5.6|-37.1|0.009
73937321|NCT03394924|147405265|SUPERIORITY||Least squares mean difference|-21.42||||0|TWO_SIDED|95.0|-32.48|-10.35|||ANCOVA|||Analysis for AST.||-10.35|-32.48|0.000
73937322|NCT03394924|147405265|SUPERIORITY||Least squares mean difference|-20.84||||0.001|TWO_SIDED|95.0|-32.8|-8.87|||ANCOVA|||Analysis for AST.||-8.87|-32.8|0.001
73937323|NCT03394924|147405265|SUPERIORITY||Least squares mean difference|-86.49||||0|TWO_SIDED|95.0|-123.78|-49.21|||ANCOVA|||Analysis for GGT.||-49.21|-123.78|0.000
73937324|NCT03394924|147405265|SUPERIORITY||Least squares mean difference|-115.13||||0|TWO_SIDED|95.0|-155.04|-75.22|||ANCOVA|||Analysis for GGT.||-75.22|-155.04|0.000
73937325|NCT03394924|147405266|SUPERIORITY||Least squares mean difference|-26.66||||0.148|TWO_SIDED|95.0|-63.1|9.79|||ANCOVA|||Analysis for HA.||9.79|-63.1|0.148
73937326|NCT03394924|147405266|SUPERIORITY||Least squares mean difference|-28.99||||0.142|TWO_SIDED|95.0|-68.02|10.05|||ANCOVA|||Analysis for HA.||10.05|-68.02|0.142
73937327|NCT03394924|147405266|SUPERIORITY||Least squares mean difference|-3.09||||0.02|TWO_SIDED|95.0|-5.68|-0.51|||ANCOVA|||Analysis for PIIINP.||-0.51|-5.68|0.02
73937328|NCT03394924|147405266|SUPERIORITY||Least squares mean difference|-3.79||||0.009|TWO_SIDED|95.0|-6.6|-0.97|||ANCOVA|||Analysis for PIIINP.||-0.97|-6.6|0.009
73937329|NCT03394924|147405266|SUPERIORITY||Least squares mean difference|-41.96||||0.015|TWO_SIDED|95.0|-75.47|-8.44|||ANCOVA|||Analysis for TIMP 1.||-8.44|-75.47|0.015
73937330|NCT03394924|147405266|SUPERIORITY||Least squares mean difference|-46.56||||0.011|TWO_SIDED|95.0|-81.91|-11.21|||ANCOVA|||Analysis for TIMP 1.||-11.21|-81.91|0.011
73937331|NCT03394924|147405266|SUPERIORITY||Least squares mean difference|-9.73||||0.018|TWO_SIDED|95.0|-17.7|-1.75|||ANCOVA|||Analysis for PRO C3.||-1.75|-17.7|0.018
73937332|NCT03394924|147405266|SUPERIORITY||Least squares mean difference|-6.73||||0.125|TWO_SIDED|95.0|-15.41|1.95|||ANCOVA|||Analysis for PRO C3.||1.95|-15.41|0.125
73937333|NCT03394924|147405267|SUPERIORITY||Least squares mean difference|-0.37||||0|TWO_SIDED|95.0|-0.56|-0.18|||ANCOVA|||||-0.18|-0.56|0.000
73937334|NCT03394924|147405267|SUPERIORITY||Least squares mean difference|-0.33||||0.002|TWO_SIDED|95.0|-0.54|-0.13|||ANCOVA|||||-0.13|-0.54|0.002
73937335|NCT03394924|147405268|SUPERIORITY||Least squares mean difference|-0.35||||0.026|TWO_SIDED|95.0|-0.65|-0.04|||ANCOVA|||||-0.04|-0.65|0.026
73937336|NCT03394924|147405268|SUPERIORITY||Least squares mean difference|-0.26||||0.104|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||||0.05|-0.57|0.104
73937337|NCT03394924|147405269|SUPERIORITY||Least squares mean difference|6.81||||0.757|TWO_SIDED|95.0|-37.17|50.78|||ANCOVA|||Analysis for fibrinogen.||50.78|-37.17|0.757
73937338|NCT03394924|147405269|SUPERIORITY||Least squares mean difference|31.77||||0.174|TWO_SIDED|95.0|-14.42|77.97|||ANCOVA|||Analysis for fibrinogen.||77.97|-14.42|0.174
73937339|NCT03394924|147405269|SUPERIORITY||Least squares mean difference|-0.98||||0.378|TWO_SIDED|95.0|-3.18|1.23|||ANCOVA|||Analysis for CRP.||1.23|-3.18|0.378
73937340|NCT03394924|147405269|SUPERIORITY||Least squares mean difference|-3.1||||0.008|TWO_SIDED|95.0|-5.38|-0.83|||ANCOVA|||Analysis for CRP.||-0.83|-5.38|0.008
73937341|NCT03394924|147405270|SUPERIORITY||Least squares mean difference|0.34||||0.841|TWO_SIDED|95.0|-3.07|3.76|||ANCOVA|||Analysis for IL6.||3.76|-3.07|0.841
73937342|NCT03394924|147405270|SUPERIORITY||Least squares mean difference|-2.49||||0.163|TWO_SIDED|95.0|-6.01|1.04|||ANCOVA|||Analysis for IL6.||1.04|-6.01|0.163
73937343|NCT03394924|147405270|SUPERIORITY||Least squares mean difference|-0.53||||0.03|TWO_SIDED|95.0|-1.02|-0.05|||ANCOVA|||Analysis for TNF α.||-0.05|-1.02|0.03
73937344|NCT03394924|147405270|SUPERIORITY||Least squares mean difference|-0.4||||0.11|TWO_SIDED|95.0|-0.9|0.09|||ANCOVA|||Analysis for TNF α.||0.09|-0.9|0.11
73937345|NCT03394924|147405271|SUPERIORITY||Least squares mean difference|0.01||||0.944|TWO_SIDED|95.0|-0.25|0.27|||ANCOVA|||Analysis for haptoglobin.||0.27|-0.25|0.944
73937346|NCT03394924|147405271|SUPERIORITY||Least squares mean difference|-0.03||||0.83|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Analysis for haptoglobin.||0.24|-0.3|0.83
73937347|NCT03394924|147405271|SUPERIORITY||Least squares mean difference|-0.04||||0.546|TWO_SIDED|95.0|-0.19|0.1|||ANCOVA|||Analysis for alpha2 macroglobulin.||0.1|-0.19|0.546
73937348|NCT03394924|147405271|SUPERIORITY||Least squares mean difference|-0.02||||0.785|TWO_SIDED|95.0|-0.18|0.13|||ANCOVA|||Analysis for alpha2 macroglobulin.||0.13|-0.18|0.785
73937349|NCT03394924|147405272|SUPERIORITY||Least squares mean difference|-0.17||||0.176|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Analysis for TG.||0.08|-0.43|0.176
73937350|NCT03394924|147405272|SUPERIORITY||Least squares mean difference|-0.04||||0.783|TWO_SIDED|95.0|-0.3|0.23|||ANCOVA|||Analysis for TG.||0.23|-0.3|0.783
73937351|NCT03394924|147405272|SUPERIORITY||Least squares mean difference|-0.64||||0.061|TWO_SIDED|95.0|-1.31|0.03|||ANCOVA|||Analysis for TC.||0.03|-1.31|0.061
73937352|NCT03394924|147405272|SUPERIORITY||Least squares mean difference|-0.63||||0.08|TWO_SIDED|95.0|-1.34|0.08|||ANCOVA|||Analysis for TC.||0.08|-1.34|0.08
73937353|NCT03394924|147405272|SUPERIORITY||Least squares mean difference|0.08||||0.584|TWO_SIDED|95.0|-0.21|0.37|||ANCOVA|||Analysis for HDL-C.||0.37|-0.21|0.584
73937354|NCT03394924|147405272|SUPERIORITY||Least squares mean difference|-0.22||||0.148|TWO_SIDED|95.0|-0.51|0.08|||ANCOVA|||Analysis for HDL-C.||0.08|-0.51|0.148
73937355|NCT03394924|147405272|SUPERIORITY||Least squares mean difference|-0.5||||0.074|TWO_SIDED|95.0|-1.04|0.05|||ANCOVA|||Analysis for LDL-C.||0.05|-1.04|0.074
73937356|NCT03394924|147405272|SUPERIORITY||Least squares mean difference|-0.3||||0.304|TWO_SIDED|95.0|-0.87|0.28|||ANCOVA|||Analysis for LDL-C.||0.28|-0.87|0.304
73937357|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|0.25||||0.378|TWO_SIDED|95.0|-0.32|0.82|||ANCOVA|||Analysis for duration.||0.82|-0.32|0.378
73937358|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|0.65||||0.03|TWO_SIDED|95.0|0.07|1.23|||ANCOVA|||Analysis for duration.||1.23|0.07|0.03
73937359|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|0.53||||0.036|TWO_SIDED|95.0|0.04|1.03|||ANCOVA|||Analysis for degree.||1.03|0.04|0.036
73937360|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|1.18||||0|TWO_SIDED|95.0|0.67|1.69|||ANCOVA|||Analysis for degree.||1.69|0.67|0.000
73937361|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|0.02||||0.971|TWO_SIDED|95.0|-0.92|0.96|||ANCOVA|||Analysis for direction.||0.96|-0.92|0.971
73937362|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|1.01||||0.042|TWO_SIDED|95.0|0.04|1.99|||ANCOVA|||Analysis for direction.||1.99|0.04|0.042
73937363|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|0.37||||0.336|TWO_SIDED|95.0|-0.4|1.14|||ANCOVA|||Analysis for disability.||1.14|-0.4|0.336
73937364|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|1.46||||0|TWO_SIDED|95.0|0.67|2.26|||ANCOVA|||Analysis for disability.||2.26|0.67|0.000
73937365|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|0.48||||0.214|TWO_SIDED|95.0|-0.29|1.25|||ANCOVA|||Analysis for distribution.||1.25|-0.29|0.214
73937366|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|1.23||||0.003|TWO_SIDED|95.0|0.44|2.02|||ANCOVA|||Analysis for distribution.||2.02|0.44|0.003
73937367|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|2.21||||0.103|TWO_SIDED|95.0|-0.47|4.9|||ANCOVA|||Analysis for total.||4.9|-0.47|0.103
73937368|NCT03394924|147405273|SUPERIORITY||Least squares mean difference|6.35||||0|TWO_SIDED|95.0|3.57|9.13|||ANCOVA|||Analysis for total.||9.13|3.57|0.000
73937369|NCT03394924|147405274|SUPERIORITY||Least squares mean difference|12.48||||0.16|TWO_SIDED|95.0|-5.09|30.06|||ANCOVA|||||30.06|-5.09|0.16
73937370|NCT03394924|147405274|SUPERIORITY||Least squares mean difference|25.58||||0.006|TWO_SIDED|95.0|7.67|43.48|||ANCOVA|||||43.48|7.67|0.006
73937371|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|-0.15||||0.908|TWO_SIDED|95.0|-2.72|2.43|||ANCOVA|||Analysis for symptoms.||2.43|-2.72|0.908
73937372|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|-1.41||||0.298|TWO_SIDED|95.0|-4.09|1.27|||ANCOVA|||Analysis for symptoms.||1.27|-4.09|0.298
73937373|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|1.91||||0.042|TWO_SIDED|95.0|0.07|3.76|||ANCOVA|||Analysis for itch.||3.76|0.07|0.042
73937374|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|3.47||||0.001|TWO_SIDED|95.0|1.55|5.38|||ANCOVA|||Analysis for itch.||5.38|1.55|0.001
73937375|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|-0.46||||0.839|TWO_SIDED|95.0|-4.96|4.04|||ANCOVA|||Analysis for fatigue.||4.04|-4.96|0.839
73937376|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|-0.32||||0.891|TWO_SIDED|95.0|-5.0|4.36|||ANCOVA|||Analysis for fatigue.||4.36|-5.00|0.891
73937377|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|0.26||||0.834|TWO_SIDED|95.0|-2.25|2.77|||ANCOVA|||Analysis for cognition.||2.77|-2.25|0.834
73937378|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|1.3||||0.327|TWO_SIDED|95.0|-1.33|3.92|||ANCOVA|||Analysis for cognition.||3.92|-1.33|0.327
74030638|NCT04964063|147615365|OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.47|-1.19|||ANOVA||Q1: How intense are the sensation|||-1.19|-1.47|<.0001
74030639|NCT04964063|147615365|OTHER||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.77|-1.45|||ANOVA||Q2: How bothered are you by any sensation|||-1.45|-1.77|<.0001
73937379|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|-2.12||||0.262|TWO_SIDED|95.0|-5.86|1.62|||ANCOVA|||Analysis for social.||1.62|-5.86|0.262
73937380|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|-0.78||||0.69|TWO_SIDED|95.0|-4.68|3.12|||ANCOVA|||Analysis for social.||3.12|-4.68|0.69
73937381|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|-0.62||||0.433|TWO_SIDED|95.0|-2.19|0.95|||ANCOVA|||Analysis for emotional.||0.95|-2.19|0.433
73937382|NCT03394924|147405275|SUPERIORITY||Least squares mean difference|0.37||||0.653|TWO_SIDED|95.0|-1.28|2.03|||ANCOVA|||Analysis for emotional.||2.03|-1.28|0.653
73937383|NCT03394924|147405279|SUPERIORITY||Least squares mean difference|1.34||||0.971|TWO_SIDED|95.0|-71.51|74.18|||ANCOVA|||Analysis for FGF19.||74.18|-71.51|0.971
73937384|NCT03394924|147405279|SUPERIORITY||Least squares mean difference|5.54||||0.882|TWO_SIDED|95.0|-68.86|79.95|||ANCOVA|||Analysis for FGF19.||79.95|-68.86|0.882
73937385|NCT03394924|147405279|SUPERIORITY||Least squares mean difference|-51.66||||0.242|TWO_SIDED|95.0|-139.27|35.96|||ANCOVA|||Analysis for C4.||35.96|-139.27|0.242
73937386|NCT03394924|147405279|SUPERIORITY||Least squares mean difference|-94.3||||0.042|TWO_SIDED|95.0|-184.85|-3.75|||ANCOVA|||Analysis for C4.||-3.75|-184.85|0.042
73937387|NCT03394924|147405279|SUPERIORITY||Least squares mean difference|-24.57||||0.52|TWO_SIDED|95.0|-101.03|51.89|||ANCOVA|||Analysis for BA.||51.89|-101.03|0.52
73937388|NCT03394924|147405279|SUPERIORITY||Least squares mean difference|-17.96||||0.672|TWO_SIDED|95.0|-103.07|67.16|||ANCOVA|||Analysis for BA.||67.16|-103.07|0.672
73937389|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|44.54||||0.611|TWO_SIDED|95.0|-205.97|295.06|||ANCOVA|||Analysis for FGF19 AUC0-8.||295.06|-205.97|0.611
73937390|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|-29.98||||0.819|TWO_SIDED|95.0|-411.28|351.31|||ANCOVA|||Analysis for FGF19 AUC0-8.||351.31|-411.28|0.819
73937391|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|24.41||||0.818|TWO_SIDED|95.0|-251.92|300.74|||ANCOVA|||Analysis for FGF19 AUC2-8.||300.74|-251.92|0.818
73937392|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|-10.53||||0.948|TWO_SIDED|95.0|-435.33|414.27|||ANCOVA|||Analysis for FGF19 AUC2-8.||414.27|-435.33|0.948
73937393|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|-91.7||||0.412|TWO_SIDED|95.0|-475.92|292.51|||ANCOVA|||Analysis for C4 AUC0-8.||292.51|-475.92|0.412
73937394|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|-250.18||||0.094|TWO_SIDED|95.0|-605.33|104.98|||ANCOVA|||Analysis for C4 AUC0-8.||104.98|-605.33|0.094
73937395|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|-83.7||||0.266|TWO_SIDED|95.0|-279.15|111.75|||ANCOVA|||Analysis for C4 AUC2-8.||111.75|-279.15|0.266
73937396|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|-238.19||||0.047|TWO_SIDED|95.0|-470.22|-6.15|||ANCOVA|||Analysis for C4 AUC2-8.||-6.15|-470.22|0.047
73937397|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|28.41||||0.694|TWO_SIDED|95.0|-180.2|237.02|||ANCOVA|||Analysis for BA AUC0-8.||237.02|-180.2|0.694
73937398|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|-39.5||||0.615|TWO_SIDED|95.0|-264.32|185.32|||ANCOVA|||Analysis for BA AUC0-8.||185.32|-264.32|0.615
73937399|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|2.93||||0.974|TWO_SIDED|95.0|-229.6|235.46|||ANCOVA|||Analysis for BA AUC2-8.||235.46|-229.6|0.974
73937400|NCT03394924|147405280|SUPERIORITY||Least squares mean difference|-26.05||||0.793|TWO_SIDED|95.0|-283.24|231.15|||ANCOVA|||Analysis for BA AUC2-8.||231.15|-283.24|0.793
73937401|NCT03387852|147405281|SUPERIORITY||Odds ratio|0.423|||=|0.0214|TWO_SIDED|95.0|0.203|0.88|||Regression, Logistic||SAR440340 300 mg vs. Placebo|Odds ratio, 95% confidence interval (CI), and p-value derived from logistic regression with treatment, baseline eosinophil strata, region, background ICS dose level at randomization and number of exacerbation events (defined as required use of systemic \[oral and/or parenteral\] steroid treatment, or required hospitalization or emergency room visit) within 1 year prior to screening.||0.88|0.203|=0.0214
74030640|NCT04964063|147615365|OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.33|-1.0|||ANOVA||Q3: How well can you tolerate sensations|||-1.00|-1.33|<.0001
74030641|NCT04964063|147615366|OTHER||Median Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.98|-1.7|||ANOVA||Q1: How intense are the sensation|||-1.70|-1.98|<.0001
73937402|NCT03387852|147405281|SUPERIORITY||Odds ratio|0.52|||=|0.0709|TWO_SIDED|95.0|0.256|1.057|||Regression, Logistic||SAR440340 + Dupilumab vs. Placebo|Odds ratio, 95% CI, and p-value derived from logistic regression with treatment, baseline eosinophil strata, region, background ICS dose level at randomization and number of exacerbation events (defined as required use of systemic \[oral and/or parenteral\] steroid treatment, or required hospitalization or emergency room visit) within 1 year prior to screening.||1.057|0.256|=0.0709
73937403|NCT04537923|147405399|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-1.24|-0.97|||Mixed Models Analysis|||||-0.97|-1.24|<0.001
73937404|NCT04537923|147405400|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-0.89|||<|0.001|TWO_SIDED|95.0|-1.08|-0.7|||Mixed Models Analysis|||||-0.70|-1.08|<0.001
74030642|NCT04964063|147615366|OTHER||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.33|-2.02|||ANOVA||Q2: How bothered are you by any sensation|||-2.02|-2.33|<.0001
73937405|NCT04537923|147405400|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.11|||<|0.001|TWO_SIDED|95.0|-1.3|-0.92|||Mixed Models Analysis|||||-0.92|-1.30|<0.001
73937406|NCT04537923|147405400|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.49|-1.11|||Mixed Models Analysis|||||-1.11|-1.49|<0.001
73937407|NCT04537923|147405401|SUPERIORITY||Odds Ratio (OR)|3.13|||<|0.0001|TWO_SIDED|95.0|2.25|4.36|||Regression, Logistic|||||4.36|2.25|<0.0001
73937408|NCT04537923|147405401|SUPERIORITY||Odds Ratio (OR)|6.16|||<|0.0001|TWO_SIDED|95.0|4.27|8.88|||Regression, Logistic|||||8.88|4.27|<0.0001
73937409|NCT04537923|147405401|SUPERIORITY||Odds Ratio (OR)|7.94|||<|0.0001|TWO_SIDED|95.0|5.37|11.75|||Regression, Logistic|||||11.75|5.37|<0.0001
73937410|NCT04537923|147405402|SUPERIORITY||LS Mean Difference|-10.7|||<|0.001|TWO_SIDED|95.0|-11.5|-9.9|||Mixed Models Analysis|||||-9.9|-11.5|<0.001
73937411|NCT04537923|147405402|SUPERIORITY||LS Mean Difference|-13.7|||<|0.001|TWO_SIDED|95.0|-14.5|-12.9|||Mixed Models Analysis|||||-12.9|-14.5|<0.001
73937412|NCT04537923|147405402|SUPERIORITY||LS Mean Difference|-15.9|||<|0.001|TWO_SIDED|95.0|-16.7|-15.0|||Mixed Models Analysis|||||-15.0|-16.7|<0.001
73937413|NCT04537923|147405403|SUPERIORITY||LS Mean Difference|-23.2|||<|0.001|TWO_SIDED|95.0|-30.8|-15.7|||Mixed Models Analysis|||||-15.7|-30.8|<0.001
73937414|NCT04537923|147405403|SUPERIORITY||LS Mean Difference|-33.0|||<|0.001|TWO_SIDED|95.0|-40.6|-25.4|||Mixed Models Analysis|||||-25.4|-40.6|<0.001
73937415|NCT04537923|147405403|SUPERIORITY||LS Mean Difference|-31.6|||<|0.001|TWO_SIDED|95.0|-39.3|-23.8|||Mixed Models Analysis|||||-23.8|-39.3|<0.001
73937416|NCT04537923|147405404|SUPERIORITY||LS Mean Difference|-0.9||||0.682|TWO_SIDED|95.0|-5.0|3.3|||Mixed Models Analysis|||||3.3|-5.0|0.682
73937417|NCT04537923|147405404|SUPERIORITY||LS Mean Difference|-5.6||||0.01|TWO_SIDED|95.0|-9.9|-1.4|||Mixed Models Analysis|||||-1.4|-9.9|0.010
73937418|NCT04537923|147405404|SUPERIORITY||LS Mean Difference|-11.8|||<|0.001|TWO_SIDED|95.0|-16.0|-7.5|||Mixed Models Analysis|||||-7.5|-16.0|<0.001
73937419|NCT04537923|147405405|SUPERIORITY||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|95.0|5.66|11.83|||Regression, Logistic|||||11.83|5.66|<0.001
73937420|NCT04537923|147405405|SUPERIORITY||Odds Ratio (OR)|16.9|||<|0.001|TWO_SIDED|95.0|11.44|24.96|||Regression, Logistic|||||24.96|11.44|<0.001
73937421|NCT04537923|147405405|SUPERIORITY||Odds Ratio (OR)|21.85|||<|0.001|TWO_SIDED|95.0|14.49|32.93|||Regression, Logistic|||||32.93|14.49|<0.001
73937422|NCT04537923|147405406|SUPERIORITY||Odds Ratio (OR)|28.25|||<|0.001|TWO_SIDED|95.0|18.36|43.46|||Regression, Logistic|||||43.46|18.36|<0.001
73937423|NCT04537923|147405406|SUPERIORITY||Odds Ratio (OR)|58.9|||<|0.001|TWO_SIDED|95.0|36.76|94.39|||Regression, Logistic|||||94.39|36.76|<0.001
73937424|NCT04537923|147405406|SUPERIORITY||Odds Ratio (OR)|77.76|||<|0.001|TWO_SIDED|95.0|47.49|127.33|||Regression, Logistic|||||127.33|47.49|<0.001
73937425|NCT04537923|147405407|SUPERIORITY||LS Mean Difference|1.5||||0.005|TWO_SIDED|95.0|0.5|2.6|||ANCOVA|||||2.6|0.5|0.005
73937426|NCT04537923|147405407|SUPERIORITY||LS Mean Difference|2.3|||<|0.001|TWO_SIDED|95.0|1.2|3.3|||ANCOVA|||||3.3|1.2|<0.001
73937427|NCT04537923|147405407|SUPERIORITY||LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.2|3.3|||ANCOVA|||||3.3|1.2|<0.001
73937428|NCT04537923|147405408|SUPERIORITY||LS Mean Difference|1.6||||0.02|TWO_SIDED|95.0|0.3|2.9|||ANCOVA|||||2.9|0.3|0.020
73937429|NCT04537923|147405408|SUPERIORITY||LS Mean Difference|2.8|||<|0.001|TWO_SIDED|95.0|1.5|4.2|||ANCOVA|||||4.2|1.5|<0.001
73937430|NCT04537923|147405408|SUPERIORITY||LS Mean Difference|2.1||||0.004|TWO_SIDED|95.0|0.7|3.5|||ANCOVA|||||3.5|0.7|0.004
73937431|NCT01261611|147405409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport NG and Placebo arms was performed. A total of 210 subjects were included in the analysis.||||<0.0001
73937432|NCT01261611|147405409|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport and Placebo arms was performed. A total of 213 subjects were included in the analysis.||||<0.0001
74030643|NCT04964063|147615366|OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.61|-1.29|||ANOVA||Q3: How well can you tolerate sensations|||-1.29|-1.61|<.0001
74030644|NCT04964063|147615367|OTHER||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.43|-2.15|||ANOVA||Q1: How intense are the sensation|||-2.15|-2.43|<.0001
74030645|NCT04964063|147615367|OTHER||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.79|-2.47|||ANOVA||Q2: How bothered are you by any sensation|||-2.47|-2.79|<.0001
73937433|NCT01261611|147405409|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An ANCOVA on the change from baseline with treatment, baseline TWSTRS Total score, BTX status at baseline and pooled centre as explanatory variables had been performed. The non-inferiority margin was 3 points.|LS mean difference|1.532|||||TWO_SIDED|95.0|-0.819|3.883||||||A pre-specified analysis of the LS mean difference between the Dysport NG and Dysport arms was performed. A total of 315 subjects were included in the analysis.||3.883|-0.819|
73937434|NCT04745169|147405435|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
73937435|NCT04745169|147405436|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
73866659|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.64|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.64|
73937436|NCT04745169|147405437|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
73937437|NCT04745169|147405438|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
73937438|NCT04745169|147405439|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
73937439|NCT04745169|147405440|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
73937440|NCT04745169|147405441|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
73937441|NCT04745169|147405442|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
73937442|NCT04745169|147405443|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
73937443|NCT02041195|147405445|OTHER||Least Squares (LS) Mean Difference|-4.26||||0.004|TWO_SIDED|90.0|-6.81|-1.72||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.72|-6.81|0.004
73937444|NCT02041195|147405445|OTHER||LS Mean difference|-3.63||||0.012|TWO_SIDED|90.0|-6.23|-1.03|||Longitudinal mixed analysis of variance|One-sided p-value.|A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.03|-6.23|0.012
73937445|NCT02041195|147405447|OTHER||LS Mean Difference|-3.57|||<|0.001|TWO_SIDED|90.0|-5.24|-1.89||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.89|-5.24|<0.001
73937446|NCT02041195|147405449|OTHER||LS Mean Difference|-2.22||||0.002|TWO_SIDED|90.0|-3.44|-1.0|||Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.00|-3.44|0.002
73937447|NCT00674986|147405459|SUPERIORITY_OR_OTHER||Difference|0.28|STANDARD_ERROR_OF_MEAN|0.14||0.0416|TWO_SIDED|95.0|0.01|0.54|||Fisher Exact|||||0.54|0.01|0.0416
73937448|NCT00674986|147405460|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73937449|NCT00674986|147405461|SUPERIORITY_OR_OTHER|||||||0.2777||95.0|||||t-test, 2 sided|||||||0.2777
73937450|NCT00674986|147405462|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||t-test, 2 sided|||||||0.1160
73937451|NCT00674986|147405463|SUPERIORITY_OR_OTHER|||||||0.1146||95.0|||||t-test, 2 sided|||||||0.1146
73937452|NCT00674986|147405464|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|||||||0.0470
73937453|NCT00674986|147405465|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
73937454|NCT01024569|147405467|SUPERIORITY||MIXREG Estimate|-1.16|STANDARD_ERROR_OF_MEAN|-2.21||0.027|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.027
73937455|NCT01024569|147405468|SUPERIORITY||MIXREG Estimate|0.4|STANDARD_ERROR_OF_MEAN|2.37||0.02|TWO_SIDED||||||Mixed Effects Random Regression|||Mixed Effects Random Regression analysis was used to assess the effects of study condition on Hope outcomes.||||0.020
73937456|NCT01024569|147405469|SUPERIORITY||MIXREG Estimate|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.029|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.029
73937457|NCT01024569|147405470|SUPERIORITY||MIXREG Estimate|1.06|STANDARD_ERROR_OF_MEAN|0.52||0.042|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.042
73937458|NCT01024569|147405471|SUPERIORITY||MIXREG Estimate|0.39|STANDARD_ERROR_OF_MEAN|0.11||0.001|TWO_SIDED||||||Mixed Effects Random Regression|||||||.001
73937459|NCT01983293|147405477|SUPERIORITY|||||||0.001|ONE_SIDED|95.0|||||Fisher Exact|||||||0.001
73937460|NCT00626522|147405503|SUPERIORITY_OR_OTHER||Least squares mean difference|0.206|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.131|0.28|||ANCOVA|||||0.280|0.131|<0.0001
73937461|NCT00626522|147405503|SUPERIORITY_OR_OTHER||Least squares mean difference|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.18|0.329|||ANCOVA|||||0.329|0.180|<0.0001
73937462|NCT00626522|147405503|SUPERIORITY_OR_OTHER||Least squares mean difference|0.265|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.191|0.34|||ANCOVA|||||0.340|0.191|<0.0001
73937463|NCT01944631|147405541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.613|STANDARD_ERROR_OF_MEAN|0.359||0.0895|TWO_SIDED|95.0|-1.321|0.095|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.095|-1.321|0.0895
73937464|NCT01944631|147405542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.176|STANDARD_ERROR_OF_MEAN|0.146||0.231|TWO_SIDED|95.0|-0.464|0.113|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.113|-0.464|0.2310
73937465|NCT01944631|147405543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.443|STANDARD_ERROR_OF_MEAN|0.304||0.1465|TWO_SIDED|95.0|-1.042|0.156|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.156|-1.042|0.1465
73937466|NCT01944631|147405544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.728|STANDARD_ERROR_OF_MEAN|3.102||0.8148|TWO_SIDED|95.0|-5.39|6.845|||ANCOVA||Difference calculated as bisolviral minus placebo|||6.845|-5.390|0.8148
73937467|NCT01944631|147405545|SUPERIORITY_OR_OTHER|||||||0.1887|TWO_SIDED||||||Log Rank|Log-rank test stratifying for the variable 'baseline TSS'||||||0.1887
73937468|NCT01944631|147405546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1069||||0.6954|TWO_SIDED|95.0|0.666|1.84|||Regression, Logistic||A value greater than one favours bisolviral|||1.840|0.666|0.6954
73937469|NCT04389762|147405547|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
73937470|NCT04389762|147405548|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
73937471|NCT04389762|147405549|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
73937472|NCT04389762|147405550|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.040
73937473|NCT04389762|147405551|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
73937474|NCT04389762|147405552|OTHER|||||||0.115|||||||t-test, 2 sided|||||||0.115
73937475|NCT04389762|147405553|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
73937476|NCT03822533|147405555|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.69|TWO_SIDED|95.0|-0.059|0.089|||t-test, 2 sided|||Mean difference using independent samples t-test.||0.089|-0.059|0.69
73937477|NCT03822533|147405555|SUPERIORITY||Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.093|0.063||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis||Presenting β-values from linear regression analysis for group variable adjusted for baseline differences in EQ-5D-3L-index. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).||0.063|-0.093|
73937478|NCT03822533|147405556|SUPERIORITY||Mean Difference (Final Values)|-364.0||||0.17|TWO_SIDED|95.0|-891.0|164.0|||t-test, 2 sided|||Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)||164|-891|0.17
73937479|NCT03822533|147405556|SUPERIORITY||Mean Difference (Final Values)|-364.0|||||TWO_SIDED|95.0|-870.0|143.0||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis||||143|-870|
73937480|NCT03822533|147405557|SUPERIORITY||Mean Difference (Final Values)|-233.0||||0.23|TWO_SIDED|95.0|-616.0|150.0|||t-test, 2 sided|||Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)||150|-616|0.23
73937481|NCT03822533|147405557|SUPERIORITY||Mean Difference (Final Values)|-233.0|||||TWO_SIDED|95.0|-605.0|139.0||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis.||Linear regression analysis. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).||139|-605|
73937482|NCT03822533|147405560|SUPERIORITY||Mean Difference (Final Values)|48.0||||0.72|TWO_SIDED|95.0|-219.0|314.0|||t-test, 2 sided|||||314|-219|0.72
73937483|NCT03822533|147405561|SUPERIORITY||Mean Difference (Final Values)|-178.0|||<|0.01|TWO_SIDED|95.0|-239.0|118.0|||t-test, 2 sided|||||118|-239|<0.01
73937484|NCT03822533|147405562|SUPERIORITY||Mean Difference (Final Values)|-24.0||||0.01|TWO_SIDED|95.0|-42.0|6.2|||t-test, 2 sided|||||6.2|-42|0.01
73937485|NCT03822533|147405563|SUPERIORITY||Mean Difference (Final Values)|-12.0||||0.62|TWO_SIDED|95.0|-59.0|36.0|||t-test, 2 sided|||||36|-59|0.62
73937486|NCT03822533|147405564|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.87|TWO_SIDED|95.0|-13.0|15.0|||t-test, 2 sided|||||15|-13|0.87
73937487|NCT03822533|147405565|SUPERIORITY||Mean Difference (Final Values)|-254.0||||0.27|TWO_SIDED|95.0|-728.0|220.0|||t-test, 2 sided|||||220|-728|0.27
74030646|NCT04964063|147615367|OTHER||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.02|-1.7|||ANOVA||Q3: How well can you tolerate sensations|||-1.70|-2.02|<.0001
73937488|NCT03822533|147405566|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.96|TWO_SIDED|95.0|-113.0|118.0|||t-test, 2 sided|||||118|-113|0.96
73937489|NCT02119416|147405698|OTHER|Maximum heart rate after 2 mg/kg of caffeine compared to baseline was assessed using a mixed effects regression model. Sex and pubertal stage were included in the model as time invariant predictors.|||||<|0.05||||||The p-value was not adjusted for multiple comparisons.|mixed effects regression|||||||<0.05
73937490|NCT02119416|147405698|OTHER|We compared means of our dependent variables after administration of different doses of caffeine.|||||<|0.05||||||The p-value was set prior to the analysis and all comparisons were planned.|ANCOVA|||We used repeated measures ANOVAS and conducted planned comparisons between groups as post-hoc tests.||||< 0.05
73937491|NCT02119416|147405699|OTHER|mixed effects regression models were used with sex and pubertal stage as time invariant predictors.|||||<|0.05|||||||mixed effects regression|||order was included in the analysis. We examined caffeine dose.||||<0.05
73937492|NCT02119416|147405699|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73937493|NCT03593655|147405705|SUPERIORITY||incidence rate ratio|1.01||||0.92|TWO_SIDED|95.0|0.9|1.12||the a priori threshold for statistical significance was \<0.05|generalized estimating equation|Poisson (log) link, adjusted for period, offset of number of visits per period, exchangeable correlation structure, and robust errors.|The incidence rate ratio compares FTC/TDF to the dapivirine vaginal ring.|Comparison of the proportion of participants experiencing a grade 2 adverse event between products, with a null hypothesis of no difference.||1.12|0.90|0.92
73937494|NCT01981564|147405711|SUPERIORITY|||||||0.06|||||||ANOVA|||ANOVA F=3.55, df=1, p=0.06||||0.06
73937495|NCT03732209|147405713|SUPERIORITY||F value, group x time interaction|7.155||||0.017|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA||Reported values in outcome measures data table reflect mean change in glycosylated hemoglobin for each group (Session 2 - Session 1)|Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.||||.017
73937496|NCT03732209|147405714|SUPERIORITY||F value, group x time interaction|4.885||||0.042|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA||The values reported in the outcome measures data table reflect mean change in AUC (Session 2 - Session 1)|Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.||||.042
73937497|NCT03732209|147405715|SUPERIORITY||F value, group x time interaction|2.33||||0.146|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA|||Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.||||.146
73937498|NCT03732209|147405716|SUPERIORITY||Median Difference (Final Values)|1.23||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.||||.042
73937499|NCT01715805|147405721|SUPERIORITY||Least Squares Mean Difference (LSMD)|-0.2||||0.7948|TWO_SIDED|95.0|-1.6|1.2||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine + ADT - Placebo + ADT|||1.2|-1.6|0.7948
73937500|NCT01715805|147405722|SUPERIORITY||LSMD|-0.7||||0.2784|TWO_SIDED|95.0|-1.9|0.5||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine +ADT - Placebo + ADT|||0.5|-1.9|0.2784
73937501|NCT03836287|147405802|OTHER||Odds Ratio (OR)|2.34||||0.0004|TWO_SIDED|95.0|1.47|3.72|||Regression, Logistic|||||3.72|1.47|0.0004
73937502|NCT03836287|147405803|OTHER||Mean Difference (Net)|-29.71|STANDARD_ERROR_OF_MEAN|9.543||0.0019|TWO_SIDED|95.0|-48.42|-11.0|||ANCOVA|||||-11.00|-48.42|0.0019
73973343|NCT06946888|147489450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.994||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.994
73973344|NCT06946888|147489450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.959||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.959
73937503|NCT02890381|147405812|OTHER||% vaccine recipients with solicited AEs|64.0|||||TWO_SIDED|90.0|35.0|86.0||||||||86|35|
73937504|NCT02890381|147405812|OTHER||% placebo recipients with solicited AEs|100.0|||||TWO_SIDED|90.0|61.0|100.0||||||||100|61|
73937505|NCT02890381|147405813|OTHER||% vaccinees with unsolicited AEs|36.0|||||TWO_SIDED|90.0|14.0|65.0||||||||65|14|
73937506|NCT02890381|147405813|OTHER||% placebo with unsolicited AEs|50.0|||||TWO_SIDED|90.0|15.0|85.0||||||||85|15|
73937507|NCT02890381|147405818|SUPERIORITY|||||||0.64||||||Since the sample sizes are unequal, at the suggestion of the DSMB statistician, a 1-sided Fisher's exact test was used to test the hypothesis that the proportions of \>=4-fold rises were higher in the vaccinated group than in the placebo group.|Fisher Exact|||||||0.64
73937508|NCT02890381|147405819|SUPERIORITY|||||||0.73||||||The threshold for statistical significance is 0.05.|Log Rank|||||||0.73
73937509|NCT00395876|147405917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.6||||0.0002||95.0|18.4|54.8||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||54.8|18.4|0.0002
73937510|NCT00395876|147405918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4||||0.1385||95.0|-3.1|25.8||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||25.8|-3.1|0.1385
73937511|NCT00395876|147405919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.9||||0.0093||95.0|7.1|42.6||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||42.6|7.1|0.0093
73937512|NCT00718718|147405928|SUPERIORITY_OR_OTHER|||||||0.026|||||||Cochran-Mantel-Haenszel|||||||0.026
73937513|NCT00718718|147405928|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cochran-Mantel-Haenszel|||||||0.052
73937514|NCT00718718|147405928|SUPERIORITY_OR_OTHER|||||||0.026|||||||Cochran-Mantel-Haenszel|||||||0.026
73937515|NCT00718718|147405928|SUPERIORITY_OR_OTHER|||||||0.104|||||||Cochran-Mantel-Haenszel|||||||0.104
73937516|NCT00718718|147405929|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
73937517|NCT00718718|147405929|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
73973345|NCT06946888|147489450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.946||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.946
73937518|NCT00718718|147405929|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
73937519|NCT00718718|147405929|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
73937520|NCT00718718|147405929|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
74008371|NCT03627767|147566506|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.8|< 0.0001
73937521|NCT00718718|147405930|SUPERIORITY_OR_OTHER|||||||0.148|||||||Cochran-Mantel-Haenszel|||||||0.148
73937522|NCT02395120|147405953|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.05|TWO_SIDED|95.0|1.21|3.08||We addressed the issue of multiple testing, both multiple comparisons and multiple sites, using a gatekeeper approach. The use of 0.05 alpha level for each test maintained a 0.05 family-wise alpha level for the six tests (three at each site).|Regression, Logistic||||The primary outcome analysis utilized generalized estimating equations (GEE) with a logit link for the binary dental care receipt outcome. The GEE analysis was conducted using dental care receipt outcomes as restorative care alone (ICDAS codes ≥3), as well as combined preventive (i.e. sealants) and restorative care (ICDAS codes ≥1). Models were fit separately to the overall data (all sites combined), the combined EC and WA sites (based on our original plan of two predominantly low-income school districts), and the BD schools alone. Each model included, as covariates, indicator variables for intervention, site (except for the model with BD alone), child grade, and caregiver demographic variables (race, education, marital status). Corresponding estimated odds ratios and 95% Confidence Intervals were computed.|3.08|1.21|<0.05
73937523|NCT01997398|147405956|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Differences in baseline and 6-month postoperative scores were assessed using a series of repeated measures general linear models with a single within-subjects factor and no between-subjects factors.|Repeated measures general linear models|||||||<0.001
73937524|NCT00778648|147405971|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||||||0.023
73937525|NCT03750552|147405976|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.413||0.574|TWO_SIDED|95.0|-1.05|0.58|||Mixed Model Repeated Measures|||||0.58|-1.05|0.574
73937526|NCT03750552|147405977|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.284||0.331|TWO_SIDED|95.0|-0.84|0.28|||Mixed Model Repeated Measures|||||0.28|-0.84|0.331
73937527|NCT03750552|147405978|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.376||0.481|TWO_SIDED|95.0|-1.01|0.48|||Mixed Model Repeated Measures|||||0.48|-1.01|0.481
73937528|NCT03750552|147405979|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.073||0.74|TWO_SIDED|95.0|-0.12|0.17|||Cochran-Mantel-Haenszel|Stratified by disease type|The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.|||0.17|-0.12|0.740
73937529|NCT03750552|147405980|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.064||0.0903|TWO_SIDED|95.0|-0.02|0.24|||Cochran-Mantel-Haenszel|Stratified by disease type|The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.|||0.24|-0.02|0.0903
73937530|NCT01259713|147406002|NON_INFERIORITY_OR_EQUIVALENCE|For the interim analysis performed when 50% of the subjects had completed the study, an alpha of 0.0003 was spent. Therefore, the significance level for the 2-sided test in the primary analysis at the end of the study was 0.0497 (corresponding to 95.03% confidence interval (CI)).|Relative risk reduction|0.33||||0.24|TWO_SIDED|95.03|-0.32|0.66||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|A two-group Cochran-Mantel-Haenszel (CMH) test with a 0.05 two-sided significance level and 2:1 allocation of 354 randomized subjects (236 AmBisome, 118 placebo) would have 81% power to detect a relative reduction of 75% if the rate of IFI is 10% in the placebo group (based on unpublished data from the German Multicenter Acute Lymphoblastic Leukemia Working Group (GMALL) and consistent with the published rate of 16.4% in patients with hematological malignancies undergoing remission induction).||0.66|-0.32|0.24
73937531|NCT01259713|147406003|SUPERIORITY_OR_OTHER||Relative risk reduction|0.25||||0.15|TWO_SIDED|95.0|-0.11|0.5||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.50|-0.11|0.15
73937532|NCT01259713|147406004|SUPERIORITY_OR_OTHER||Relative risk reduction|-0.01||||0.97|TWO_SIDED|95.0|-0.94|0.47||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.47|-0.94|0.97
73937533|NCT01259713|147406005|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||The p-value is from the log-rank test stratified by region.|Log Rank|||||||0.33
73937534|NCT01259713|147406006|SUPERIORITY_OR_OTHER||Relative risk reduction|0.25||||0.22|TWO_SIDED|95.0|-0.19|0.53||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.53|-0.19|0.22
73937535|NCT01259713|147406007|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel|||||||0.32
73973346|NCT06946888|147489450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.715||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.715
74008372|NCT03627767|147566506|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-0.4|
74008373|NCT03627767|147566506|SUPERIORITY||LSM difference|-0.4|||=|0.1136|TWO_SIDED|95.0|-1.0|0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.0|= 0.1136
73937536|NCT01259713|147406008|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel|||||||0.32
73937537|NCT01259713|147406009|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED|||||The p-value was from the log-rank test stratified by region.|Log Rank|Participants without consolidation/salvage therapy dates were censored using the earlier of the Early Termination and Study Completion dates.||||||0.69
73937538|NCT01259713|147406010|SUPERIORITY_OR_OTHER||Relative risk reduction|0.08||||0.2|TWO_SIDED|95.0|-0.04|0.19||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|Participants were not stratified for leukemia risk.||0.19|-0.04|0.20
73937539|NCT06111742|147406011|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Induction||||<0.001
73937540|NCT06111742|147406011|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||OR entry||||<0.001
73937541|NCT06111742|147406012|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||||||0.022
73937542|NCT06111742|147406014|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
73937543|NCT03814889|147406015|OTHER|||||||0.00025|||||||Wilcoxon Signed-Rank|Paired, ordinal data||||||0.00025
73937544|NCT03814889|147406016|OTHER|||||||0.0014|||||||Wilcoxon Signed-Rank|||||||0.0014
73937545|NCT03814889|147406017|OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
73937546|NCT03814889|147406018|OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
73937547|NCT03814889|147406021|OTHER|||||||0.001|||||||Wilcoxcon Signed-Ranks|||||||0.001
74008374|NCT03627767|147566506|SUPERIORITY||LSM difference|-0.6|||=|0.0276|TWO_SIDED|95.0|-1.1|-0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.1|= 0.0276
74008375|NCT03627767|147566506|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.5|0.2||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.5|
74008376|NCT03627767|147566506|SUPERIORITY||LSM difference|-0.9|||=|0.0108|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.5|= 0.0108
73937548|NCT00958919|147406023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.0004|TWO_SIDED|95.0|2.69|9.38|||t-test, 2 sided|||||9.38|2.69|.0004
73937549|NCT00958919|147406024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.024|TWO_SIDED|95.0|0.49|6.85|||t-test, 2 sided|||||6.85|0.49|.024
73937550|NCT00958919|147406025|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||||||0.45
73937551|NCT00958919|147406026|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73937552|NCT00958919|147406027|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73937553|NCT02103439|147406039|NON_INFERIORITY_OR_EQUIVALENCE|the lower limit of the 95% confidence interval for the difference in proportions between the difference in the early virological response rate with Algeron and PegIntron should be higher than the non-inferiority margin of 0.2 (-20%)||||||0.227|TWO_SIDED||||||Fisher Exact|||||||0.227
73937554|NCT02103439|147406040|NON_INFERIORITY_OR_EQUIVALENCE|the lower limit of the 95 % confidence interval between the difference in rate of rapid virological response with Algeron and PegIntron should be more than the non-inferiority margin (-20 %)|||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||> 0.05
73937555|NCT01201629|147406061|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
74008377|NCT03627767|147566506|SUPERIORITY||LSM difference|-0.6|||=|0.0677|TWO_SIDED|95.0|-1.3|0.0|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.0|-1.3|= 0.0677
74008378|NCT03627767|147566506|SUPERIORITY||LSM difference|0.3|||||TWO_SIDED|95.0|-0.2|0.7||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.2|
73866660|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.59|-0.14||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.14|-0.59|
73866661|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-0.54|-0.09||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.09|-0.54|
73866662|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-0.81|-0.35||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.35|-0.81|
73866663|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.01|0.34||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.34|-0.01|
73866664|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.1|0.24||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.24|-0.10|
73866665|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.1|0.25||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.25|-0.10|
73866666|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.17|0.18||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.18|-0.17|
73866667|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.13|0.51||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.51|0.13|
74030647|NCT04964063|147615368|OTHER||Mean Difference (Final Values)|-2.54|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.68|-2.4|||ANOVA||Q1: How intense are the sensation|||-2.40|-2.68|<.0001
73937556|NCT01201629|147406062|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73937557|NCT03858803|147406066|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
73937558|NCT03858803|147406067|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
73937559|NCT03858803|147406068|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
73866668|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.11|0.27||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.27|-0.11|
73937560|NCT03858803|147406069|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
73937561|NCT03858803|147406070|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
73937562|NCT03858803|147406071|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
73937563|NCT03858803|147406072|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
73937564|NCT03858803|147406073|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
73937565|NCT03858803|147406074|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
73937566|NCT03858803|147406075|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
73937567|NCT03858803|147406076|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
73937568|NCT01358526|147406080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.163||0.0055|TWO_SIDED|95.0|0.13|0.77||A gate-keeping strategy and a Bonferroni-Holm method was used to control the family-wise (primary and secondary efficacy analysis) error rate at the 5% level.|Mixed Models Analysis|Mixed-model repeated measures analysis of pain data using a pattern mixture model framework||||0.77|0.13|0.0055
73937569|NCT01358526|147406081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|2.26||0.0191|TWO_SIDED|95.0|0.9|9.8|||Mixed Models Analysis|Mixed-model repeated measures analysis|Mean difference (final values) is the treatment comparison estimated using mixed model repeated measures analysis with effect for treatment, time (weeks 4, 8, 12), treatment by time interaction, and prerandomization value. Subject is a random effect.|||9.8|0.9|0.0191
73937570|NCT01358526|147406082|SUPERIORITY_OR_OTHER|||||||0.0002||||||"The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test"|Fisher Exact|||||||0.0002
73937571|NCT01358526|147406083|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 30%||||0.0006
74030648|NCT04964063|147615368|OTHER||Mean Difference (Final Values)|-2.89|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.05|-2.73|||ANOVA||Q2: How bothered are you by any sensation|||-2.73|-3.05|<.0001
74030649|NCT04964063|147615368|OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.2|-1.87|||ANOVA||Q3: How well can you tolerate sensations|||-1.87|-2.20|<.0001
74030650|NCT04964063|147615369|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.84|-2.55|||ANOVA||Q1: How intense are the sensation|||-2.55|-2.84|<.0001
73937572|NCT01358526|147406084|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 50%||||0.0018
73937573|NCT02194621|147406173|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||>0.05
73937574|NCT02194621|147406174|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
73937575|NCT02194621|147406175|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||>0.05
73937576|NCT02194621|147406176|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.002
73937577|NCT05054816|147406288|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections.||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
73937578|NCT05054816|147406289|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
73937579|NCT05054816|147406290|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
73937580|NCT05054816|147406291|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between two conditions: investigative feature, comparative feature 1|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
73937581|NCT05054816|147406292|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
73937582|NCT02010060|147406327|SUPERIORITY|||||||0.074|||||||ANCOVA|||||||0.074
73937583|NCT02010060|147406327|SUPERIORITY|||||||0.684|||||||ANCOVA|||Change in waist circumference between AERO and CON||||0.684
73937584|NCT02010060|147406327|SUPERIORITY|||||||0.18|||||||ANCOVA|||Comparison between the AERO group and the AERO-PA group||||0.180
73937585|NCT02010060|147406328|SUPERIORITY|||||||0.011|||||||ANCOVA|||Change in body fat between the AERO-PA group and the CON group||||0.011
73937586|NCT02010060|147406328|SUPERIORITY|||||||0.16|||||||ANCOVA|||||||0.16
73937587|NCT02010060|147406328|SUPERIORITY|||||||0.258|||||||ANCOVA|||Change in body fat between the AERO and AERO-PA group||||0.258
73937588|NCT02010060|147406329|SUPERIORITY|||||||0.104|||||||ANCOVA|||Comparison of body weight between the CON and AERO-PA groups||||0.104
73937589|NCT02010060|147406329|SUPERIORITY|||||||0.578|||||||ANCOVA|||Change in body weight between the CON and AERO groups||||0.578
73937590|NCT02010060|147406329|SUPERIORITY|||||||0.3|||||||ANCOVA|||Change in body weight between the AERO and AERO-PA groups||||0.300
73937591|NCT02010060|147406330|SUPERIORITY|||||||0.002|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groups||||0.002
73937592|NCT02010060|147406330|SUPERIORITY|||||||0.314|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) AERO and CON groups||||0.314
73937593|NCT02010060|147406330|SUPERIORITY|||||||0.041|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groups||||0.041
73937594|NCT02010060|147406331|SUPERIORITY|||||||0.891|||||||ANCOVA|||Change in insulin sensitivity between the CON and AERO-PA groups||||0.891
73937595|NCT02010060|147406331|SUPERIORITY|||||||0.417|||||||ANCOVA|||Change in insulin sensitivity between the CON and AERO groups||||0.417
73937596|NCT02010060|147406331|SUPERIORITY|||||||0.484|||||||ANCOVA|||Change in insulin sensitivity between the AERO and AERO-PA groups||||0.484
73937597|NCT02010060|147406332|SUPERIORITY|||||||0.274|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between the CON and the AERO groups||||0.274
73937598|NCT02010060|147406332|SUPERIORITY|||||||0.461|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between the CON and AERO groups||||0.461
73937599|NCT02010060|147406332|SUPERIORITY|||||||0.739|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between AERO and AERO-PA groups||||0.739
73937600|NCT02010060|147406333|SUPERIORITY|||||||0.837|||||||ANCOVA|||Change in high density lipoprotein (HDL) between the CON and AERO-PA group||||0.837
73937601|NCT02010060|147406333|SUPERIORITY|||||||0.895|||||||ANCOVA|||Change in high density lipoprotein (HDL) between the CON and AERO groups||||0.895
73937602|NCT02010060|147406333|SUPERIORITY|||||||0.744|||||||ANCOVA|||||||0.744
73937603|NCT02010060|147406334|SUPERIORITY|||||||0.067|||||||ANCOVA|||Change in total cholesterol (mg/dL)||||0.067
73937604|NCT02010060|147406334|SUPERIORITY|||||||0.254|||||||ANCOVA|||Change in total cholesterol (mg/dL) between the CON and AERO groups||||0.254
73937605|NCT02010060|147406334|SUPERIORITY|||||||0.501|||||||ANCOVA|||Change in total cholesterol (mg/dL) between AERO and AERO-PA groups||||0.501
73937606|NCT02010060|147406335|SUPERIORITY|||||||0.456|||||||ANCOVA|||Change in triglyceride level between the AERO-PA and CON groups||||0.456
73937607|NCT02010060|147406335|SUPERIORITY|||||||0.422|||||||ANCOVA|||Change in triglyceride level between the CON and AERO groups||||0.422
73937608|NCT02010060|147406335|SUPERIORITY|||||||0.136|||||||ANCOVA|||Change in triglyceride level between the AERO and AERO-PA groups||||0.136
73937609|NCT02010060|147406336|SUPERIORITY|||||||0.483|||||||ANCOVA|||Change in glucose level between the CON and AERO-PA groups||||0.483
73937610|NCT02010060|147406336|SUPERIORITY|||||||0.274|||||||ANCOVA|||Change in glucose between the CON and AERO groups||||0.274
73937611|NCT02010060|147406336|SUPERIORITY|||||||0.685|||||||ANCOVA|||Change in glucose level between the AERO and AERO-PA groups||||0.685
73937612|NCT02010060|147406337|SUPERIORITY|||||||0.489|||||||ANCOVA|||Change in systemic inflammation between CON and AERO-PA groups||||0.489
73937613|NCT02010060|147406337|SUPERIORITY|||||||0.652|||||||ANCOVA|||Change in systemic inflammation between the CON and AERO groups||||0.652
73937614|NCT02010060|147406337|SUPERIORITY|||||||0.822|||||||ANCOVA|||Change in systemic inflammation between the AERO and AERO-PA groups||||0.822
73937615|NCT02010060|147406338|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes in steps between the CON group and the AERO-PA group||||<0.001
74008379|NCT03627767|147566506|SUPERIORITY||LSM difference|-0.5|||=|0.132|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.1|= 0.1320
74008380|NCT03627767|147566506|SUPERIORITY||LSM difference|-0.3|||=|0.2975|TWO_SIDED|95.0|-0.9|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.9|= 0.2975
73937616|NCT02010060|147406338|SUPERIORITY|||||||0.648|||||||ANCOVA|||Changes in steps between the CON and the AERO group||||0.648
73937617|NCT02010060|147406338|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes in steps between the AERO and AERO-PA groups||||<0.001
73937618|NCT02010060|147406339|SUPERIORITY|||||||0.226|||||||ANCOVA|||Change in kilocalories (dietary intake) between CON and AERO-PA group||||0.226
73937619|NCT02010060|147406339|SUPERIORITY|||||||0.215|||||||ANCOVA|||Change in caloric intake between the CON and the AERO groups||||0.215
73937620|NCT02010060|147406339|SUPERIORITY|||||||0.957|||||||ANCOVA|||Change in caloric intake (kilocalories) between the AERO and AERO-PA groups||||0.957
73937621|NCT02010060|147406340|SUPERIORITY|||||||0.337|||||||ANCOVA|||Change in insulin concentration between the CON and AERO-PA group||||0.337
73937622|NCT02010060|147406340|SUPERIORITY|||||||0.77|||||||ANCOVA|||Change in insulin level between the AERO and CON groups||||0.770
73937623|NCT02010060|147406340|SUPERIORITY|||||||0.515|||||||ANCOVA|||Change in insulin concentration between AERO and AERO-PA groups||||0.515
73937624|NCT00920426|147406456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|||<|0.001|TWO_SIDED|95.0|-2.547|-1.632||Analysis of covariance (ANCOVA) with treatment as fixed effect, and Baseline HIV-1 RNA as covariate.|ANCOVA|||||-1.632|-2.547|<0.001
73937625|NCT00920426|147406482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.804|||<|0.001|TWO_SIDED|95.0|-2.173|-1.436||ANCOVA with treatment as fixed effect, and baseline HIV-1 RNA as covariate.|ANCOVA|||||-1.436|-2.173|<0.001
73937626|NCT00920426|147406483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73937627|NCT01808690|147406508|SUPERIORITY|||||||0.005||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted multivariable models, which included sex, pubertal status, change in BMI, and baseline M/I.||Insulin function was defined as M/I (mg/kg/min)/(insulin). Power calculations were based on data from a small study in youth with poorly controlled T1DM, which reported a significant increase in M/I in the 11 participants treated with Metformin. On the basis of the effect size reported in that study, a sample size of 25 per group and an alpha of 0.05 provided us with 93% power to detect a difference of 1 SD in the primary outcome of M/I.||||0.005
73937628|NCT01808690|147406509|SUPERIORITY|||||||0.46||||||Threshold for statistical significance P=0.05|Regression, Linear|Adjusted for the baseline value of the variable, sex, age, change in VO2peak, change in insulin sensitivity, and treatment condition.||||||0.46
73937629|NCT01808690|147406510|SUPERIORITY|||||||0.04||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.||||||0.04
73937630|NCT01808690|147406511|SUPERIORITY|||||||0.04||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.||||||0.04
73937631|NCT01808690|147406512|SUPERIORITY|||||||0.01||||||Threshold for statistical significance P=0.05|Regression, Linear|Adjusted for the baseline value of BMI percentile, diabetes duration, and A1c.||||||0.01
73937632|NCT01808690|147406513|SUPERIORITY|||||||0.03||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.||||||0.03
73937633|NCT01808690|147406514|SUPERIORITY|||||||0.8||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.||||||0.8
73937634|NCT01461668|147406525|SUPERIORITY||Odds Ratio (OR)|0.41||||0.32|TWO_SIDED|95.0|0.08|1.86|||Fisher Exact||Confidence interval for the odds ratio is based upon the inversion Fisher's exact test|||1.86|0.08|0.320
73937635|NCT00377234|147406526|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Null hypothesis: Preference rate (including patients not expressing treatment preference and considering order treatments were received) for monthly ibandronate = 50%. Null hypothesis is rejected if P-value was below significance threshold of P \<0.05|Garts Test|||||||<0.0001
73937636|NCT00377234|147406526|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The reported p-values for the primary analysis test whether the overall preference rate for ibandronate equals 50%. Preference within each sequence is not tested.|Prescott Test|||||||<0.0001
73937637|NCT01880424|147406531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.001||95.0|1.21|2.09||Statistical significance (p\<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.||2.09|1.21|0.0010
73937638|NCT01880424|147406532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56|||<|0.0001||95.0|1.83|3.58||Statistical significance (p\<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.||3.58|1.83|<0.0001
73937639|NCT02212028|147406547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.0||||0.022|TWO_SIDED|95.0|10.0|126.0|||ANOVA|||||126|10|0.022
73937640|NCT02212028|147406548|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||||||0.005
73937641|NCT00581230|147406549|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Wilcoxon signed rank test|||||||0.0003
73937642|NCT00581230|147406550|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
73937643|NCT01369342|147406843|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
73937644|NCT01369342|147406843|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
73937645|NCT01369342|147406844|SUPERIORITY_OR_OTHER|||||||0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||0.009
73937646|NCT01369342|147406844|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
73937647|NCT01369342|147406845|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
73937648|NCT01369342|147406845|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
73937649|NCT01369342|147406846|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
73937650|NCT01369342|147406846|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
73937651|NCT01369342|147406847|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
73937652|NCT01369342|147406847|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
73937653|NCT00321854|147406848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.9||0.6503||95.0|-2.2|1.4|||ANCOVA|||||1.4|-2.2|0.6503
73937654|NCT00321854|147406849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.9||0.9568||95.0|-1.7|1.8|||ANCOVA|||||1.8|-1.7|0.9568
73937655|NCT00321854|147406850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-6.3|-3.2|||ANCOVA|||||-3.2|-6.3|<0.0001
73937656|NCT00321854|147406851|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001||95.0|-5.8|-3.0|||ANCOVA|||||-3|-5.8|<0.0001
73937657|NCT00321854|147406852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.1|-1.7|||ANCOVA|||||-1.7|-4.1|<0.0001
73937658|NCT00321854|147406853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.9||0.8693||95.0|-1.8|1.5|||ANCOVA|||||1.5|-1.8|0.8693
73937659|NCT00321854|147406854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.9||0.8155||95.0|-1.5|1.9|||ANCOVA|||||1.9|-1.5|0.8155
73937660|NCT00321854|147406855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-6.0|-3.0|||ANCOVA|||||-3|-6|<0.0001
73937661|NCT00321854|147406856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001||95.0|-5.4|-2.6|||ANCOVA|||||-2.6|-5.4|<0.0001
74030651|NCT04964063|147615369|OTHER||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.15|-2.83|||ANOVA||Q2: How bothered are you by any sensation|||-2.83|-3.15|<.0001
74030652|NCT04964063|147615369|OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.35|-2.02|||ANOVA||Q3: How well can you tolerate sensations|||-2.02|-2.35|<.0001
73937662|NCT00321854|147406857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-3.9|-1.7|||ANCOVA|||||-1.7|-3.9|<0.0001
73937663|NCT00321854|147406858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7999||95.0|-1.5|1.1|||ANCOVA|||||1.1|-1.5|0.7999
73937664|NCT00321854|147406859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7395||95.0|-1.1|1.5|||ANCOVA|||||1.5|-1.1|0.7395
73937665|NCT00321854|147406860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.5|-2.2|||ANCOVA|||||-2.2|-4.5|<0.0001
73937666|NCT00321854|147406861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.0|-1.8|||ANCOVA|||||-1.8|-4|<0.0001
73937667|NCT00321854|147406862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.5||0.0002||95.0|-2.7|-0.9|||ANCOVA|||||-0.9|-2.7|0.0002
73937668|NCT00321854|147406863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9256||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.9256
73937669|NCT00321854|147406864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9792||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.9792
73937670|NCT00321854|147406865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.3||0.0001||95.0|-1.7|-0.5|||ANCOVA|||||-0.5|-1.7|0.0001
73937671|NCT00321854|147406866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|-1.6|-0.6|||ANCOVA|||||-0.6|-1.6|<0.0001
73937672|NCT00321854|147406867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.5|-0.6|||ANCOVA|||||-0.6|-1.5|<0.0001
73937673|NCT00321854|147406868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0376||95.0|-0.5|0.0|||ANCOVA|||||0|-0.5|0.0376
73937674|NCT00321854|147406869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1607||95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.1607
73937675|NCT00321854|147406870|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0173||95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|0.0173
73937676|NCT00321854|147406871|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0007||95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0007
73937677|NCT00321854|147406872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4381||95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.4381
73937678|NCT00321854|147406873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.796||||0.5116||95.0|0.403|1.573|||Regression, Logistic|||||1.573|0.403|0.5116
73937679|NCT00321854|147406874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.153||||0.7913||95.0|0.403|3.299|||Regression, Logistic|||The ordinal responses (3 levels) were analysed using the proportional odds model extension of logistic regression||3.299|0.403|0.7913
73937680|NCT00321854|147406875|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1702||95.0|-1.3|0.2|||ANCOVA|||||0.2|-1.3|0.1702
73937681|NCT00321854|147406876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.0009||95.0|-2.2|-0.6|||ANCOVA|||||-0.6|-2.2|0.0009
73937682|NCT00321854|147406877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.0005||95.0|-2.1|-0.6|||ANCOVA|||||-0.6|-2.1|0.0005
73937683|NCT00321854|147406878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0422||95.0|-1.4|0.0|||ANCOVA|||||0|-1.4|0.0422
73937684|NCT00321854|147406879|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.573||||0.2149||95.0|-1.823|0.677|||Wilcoxon (Mann-Whitney)|||||0.677|-1.823|0.2149
73937685|NCT00321854|147406880|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.031||||0.0001||95.0|-3.125|-0.938|||Wilcoxon (Mann-Whitney)|||||-0.938|-3.125|0.0001
73937686|NCT00321854|147406881|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.2605||95.0|0.0|0.026|||Wilcoxon (Mann-Whitney)|||||0.026|0|0.2605
73937687|NCT00321854|147406882|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.051|||<|0.0001||95.0|0.0|0.089|||Wilcoxon (Mann-Whitney)|||||0.089|0|<0.0001
73937688|NCT00321854|147406883|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.0||||0.0489||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|0|0.0489
73937689|NCT00321854|147406884|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.0||||0.0282||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|0|0.0282
73937690|NCT00321854|147406900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|2.5||0.8397||95.0|-5.4|4.4|||ANCOVA|||||4.4|-5.4|0.8397
73937691|NCT04723576|147406905|OTHER|Standard 2-sided non-equivalence test|Mean Difference (Net)|0.189||||0.77|TWO_SIDED|95.0|-1.068|1.446|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||1.446|-1.068|.77
73937692|NCT04723576|147406906|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.238||||0.39|TWO_SIDED|95.0|-0.31|0.785|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.785|-0.310|.39
73937693|NCT04723576|147406907|OTHER|Standard 2-sided non-equivalence test|Mean Difference (Net)|-0.232||||0.24|TWO_SIDED|95.0|-0.618|0.153|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.153|-0.618|.24
73937694|NCT04723576|147406908|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.134||||0.23|TWO_SIDED|95.0|-0.085|0.352|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.352|-0.085|.23
73937695|NCT04723576|147406909|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|-0.051||||0.44|TWO_SIDED|95.0|-0.179|0.078|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.078|-0.179|.44
73937696|NCT04723576|147406910|OTHER|Standard 2-sided non-equivalence test|Odds Ratio, log|-0.051||||0.85|TWO_SIDED|95.0|-0.179|0.078|||Repeated measure logistic regression|using GEE method|Effect sizes are the difference between SFA minus Usual Care.|||0.078|-0.179|.85
74030653|NCT04964063|147615370|OTHER||Median Difference (Final Values)|-2.94|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-3.08|-2.79|||ANOVA||Q1: How intense are the sensation|||-2.79|-3.08|<.0001
74030654|NCT04964063|147615370|OTHER||Median Difference (Final Values)|-3.24|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.4|-3.08|||ANOVA||Q2: How bothered are you by any sensation|||-3.08|-3.40|<.0001
73866669|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.04|0.34||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.34|-0.04|
73866670|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.13|0.25||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.25|-0.13|
73937697|NCT04723576|147406911|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.23||||0.08|TWO_SIDED|95.0|-0.025|0.484|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care|||0.484|-0.025|.08
73937698|NCT00413153|147406912|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||Initial samples size of N=16 calculated to provide 80% power to detect a 30% change in muscle glucose uptake between groups. Student's t-test used to compare change from baseline and determine treatment effect (net difference over time between the ATV/r vs. LPV/r groups).||||0.035
73937699|NCT00413153|147406913|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs. LPV/r)||||0.12
73937700|NCT00413153|147406914|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.002
73937701|NCT00413153|147406915|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.02
73937702|NCT00413153|147406916|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|||||||0.047
73937703|NCT00413153|147406917|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.72
73937704|NCT00413153|147406918|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.22
73937705|NCT00413153|147406919|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Repeated Measures Ancova|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.004
73937706|NCT00413153|147406920|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.0002
73937707|NCT03204279|147406923|OTHER|No comparison between the two dose groups is performed, thus no statistical test is applied. In the next section the goodness of fit of the loess function correlating exposure and response is reported.|Pearson R|0.076||||0.55|TWO_SIDED|||||CR in the delayed phase vs AUC0-inf|loess (Local regression or polynomial)|The p-value represents the probability found if the correlation coefficient was zero (null hypothesis).|R is the Pearson correlation is a coefficient statistic that measures linear correlation between two variables CR in the delayed phase vs AUC0-inf|The population consist of all patients having CR in the delayed phase and AUC0-inf and Cmax, there is no comparison between the two dose groups.||||0.55
73937708|NCT03204279|147406923|OTHER|No comparison between the two dose groups is performed, thus no statistical test is applied. In the next section the goodness of fit of the loess function correlating exposure and response is reported.|Pearson R|-0.041||||0.75|TWO_SIDED|||||CR in the delayed phase vs Cmax|loess (Local regression or polynomial)|The p-value represents the probability found if the correlation coefficient was zero (null hypothesis).|R is the Pearson correlation is a coefficient statistic that measures linear correlation between two variables CR in the delayed phase vs Cmax|The population consist of all patients having CR in the delayed phase and AUC0-inf and Cmax, there is no comparison between the two dose groups.||||0.75
73937709|NCT04969250|147406928|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
73937710|NCT04969250|147406929|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.40
73937711|NCT04969250|147406930|SUPERIORITY|||||||0.078|||||||Fisher Exact|||||||0.078
73937712|NCT04969250|147406931|SUPERIORITY|||||||0.033|||||||Fisher Exact|||||||0.033
73937713|NCT02071173|147406945|SUPERIORITY|Single group test comparison to a performance goal of 87%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|98.5|||||ONE_SIDED|97.5|97.0|||||||Ho: The Implant through 6-month lead-related complication-free rate ≤ 87%, Ha: The Implant through 6-month lead-related complication-free rate \> 87%|||97.0|
73937714|NCT02071173|147406946|SUPERIORITY|Single group test comparison to a performance goal of 85%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|96.5|||||ONE_SIDED|95.0|93.8|||||||Ho: The Implant through 6-month lead-related complication-free rate ≤ 85%, Ha: The Implant through 6-month lead-related complication-free rate \> 85%|||93.8|
74030655|NCT04964063|147615370|OTHER||Mean Difference (Final Values)|-2.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.53|-2.21|||ANOVA||Q3: How well can you tolerate sensations|||-2.21|-2.53|<.0001
73866671|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.13|0.52||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.52|0.13|
73866672|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.12|0.27||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.27|-0.12|
73866673|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.05|0.35||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.35|-0.05|
73866674|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.08|0.31||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.31|-0.08|
73866675|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|0.28|0.73||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.73|0.28|
73866676|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.05|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.05|
73866677|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.06|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.06|
73866678|NCT01393639|147278697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|||||TWO_SIDED|95.0|-0.01|0.44||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.01|
73866679|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.78|-0.04||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.04|-0.78|
73866680|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||||TWO_SIDED|95.0|-1.12|-0.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.39|-1.12|
73866681|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|||||TWO_SIDED|95.0|-1.18|-0.44||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.44|-1.18|
73866682|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|95.0|-1.48|-0.74||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.74|-1.48|
73866683|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.72|0.02||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.02|-0.72|
73866684|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|||||TWO_SIDED|95.0|-1.19|-0.46||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.46|-1.19|
73866685|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|||||TWO_SIDED|95.0|-0.85|0.0||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.00|-0.85|
73866686|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|||||TWO_SIDED|95.0|-1.15|-0.31||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.31|-1.15|
73866687|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-1.37|-0.52||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.52|-1.37|
74008381|NCT03627767|147566506|SUPERIORITY||LSM difference|0.2|||||TWO_SIDED|95.0|-0.2|0.6||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.2|
74030656|NCT04964063|147615372|OTHER||Mean Difference (Final Values)|-17.93|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-20.81|-15.05|||ANOVA|||||-15.05|-20.81|<.0001
73866688|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.39|-0.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.39|
73866689|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|||||TWO_SIDED|95.0|-0.67|0.18||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.18|-0.67|
74030657|NCT04964063|147615373|OTHER||Mean Difference (Final Values)|-31.2|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-34.04|-28.36|||ANOVA|||||-28.36|-34.04|<.0001
74030658|NCT04964063|147615374|OTHER||Mean Difference (Final Values)|-39.45|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-42.3|-36.59|||ANOVA|||||-36.59|-42.30|<.0001
74030659|NCT04964063|147615375|OTHER||Mean Difference (Final Values)|-44.37|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-47.24|-41.49|||ANOVA|||||-41.49|-47.24|<.0001
73973347|NCT06946888|147489450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.422||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.422
73973348|NCT06946888|147489450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.379||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.379
73973349|NCT06946888|147489450|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.302||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.302
73973350|NCT06946888|147489451|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.913||||||This is the first week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 1.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.913
74008382|NCT03627767|147566507|SUPERIORITY||LSM difference|-0.4|||=|0.3531|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-1.3|= 0.3531
74008383|NCT03627767|147566507|SUPERIORITY||LSM difference|0.0|||=|0.9282|TWO_SIDED|95.0|-0.8|0.9|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.9|-0.8|= 0.9282
74008384|NCT03627767|147566507|SUPERIORITY||LSM difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.3|-0.4|
74008385|NCT03627767|147566507|SUPERIORITY||LSM difference|-6.1|||<|0.0001|TWO_SIDED|95.0|-7.3|-5.0|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.0|-7.3|< 0.0001
74030660|NCT04964063|147615376|OTHER||Mean Difference (Final Values)|-48.04|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-50.96|-45.12|||ANOVA|||||-45.12|-50.96|<.0001
74030661|NCT04964063|147615377|OTHER||Mean Difference (Final Values)|-52.47|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-55.33|-49.62|||ANOVA|||||-49.62|-55.33|<.0001
74030662|NCT04964063|147615379|OTHER||Mean Difference (Final Values)|-2.45|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.88|-2.02|||ANOVA|||||-2.02|-2.88|<.0001
74030663|NCT04964063|147615380|OTHER||Mean Difference (Final Values)|-4.27|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-4.69|-3.85|||ANOVA|||||-3.85|-4.69|<.0001
74030664|NCT04964063|147615381|OTHER||Mean Difference (Final Values)|-5.71|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-6.13|-5.28|||ANOVA|||||-5.28|-6.13|<.0001
74030665|NCT04964063|147615382|OTHER||Mean Difference (Final Values)|-6.45|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-6.88|-6.02|||ANOVA|||||-6.02|-6.88|<.0001
73973351|NCT06946888|147489451|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.802||||||This is the second week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 2.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.802
73973352|NCT06946888|147489451|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.605||||||This is the third week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 3.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.605
73973353|NCT06946888|147489451|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.35||||||This is the fourth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 4.||Generalized Estimating Equations were used to analyze repeated measures data and to assess the interaction effect between group and time. Potential interfering factors such as age and years of work experience were controlled during the analysis, and the effect size (Cohen's d) and its 95% confidence interval were calculated to assist in interpreting the clinical significance. Statistical analysis was performed using SPSS version XX or R version XX, and the significance level was set at p \< 0.05.||||0.350
73973354|NCT06946888|147489451|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||1||||||This is the fifth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 5.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||1.000
74008386|NCT03627767|147566507|SUPERIORITY||LSM difference|-9.2|||<|0.0001|TWO_SIDED|95.0|-10.3|-8.1|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-8.1|-10.3|< 0.0001
74008387|NCT03627767|147566507|SUPERIORITY||LSM difference|-3.1|||||TWO_SIDED|95.0|-4.0|-2.1||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.1|-4.0|
74030666|NCT04964063|147615383|OTHER||Median Difference (Final Values)|-7.01|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-7.45|-6.58|||ANOVA|||||-6.58|-7.45|<.0001
74030667|NCT04964063|147615384|OTHER||Mean Difference (Final Values)|-7.44|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-7.87|-7.01|||ANOVA|||||-7.01|-7.87|<.0001
74030668|NCT04964063|147615386|OTHER||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-7.46|-5.2|||ANOVA|||||-5.20|-7.46|<.0001
74030669|NCT04964063|147615387|OTHER||Mean Difference (Final Values)|-11.53|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-12.64|-10.41|||ANOVA|||||-10.41|-12.64|<.0001
74030670|NCT04964063|147615388|OTHER||Mean Difference (Final Values)|-14.54|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-15.66|-13.42|||ANOVA|||||-13.42|-15.66|<.0001
74030671|NCT04964063|147615389|OTHER||Median Difference (Final Values)|-16.54|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-17.67|-15.41|||ANOVA|||||-15.41|-17.67|<.0001
73866690|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|95.0|-1.33|-0.49||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.49|-1.33|
73866691|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.9|0.02||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.02|-0.90|
74030672|NCT04964063|147615390|OTHER||Mean Difference (Final Values)|-17.73|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-18.87|-16.58|||ANOVA|||||-16.58|-18.87|<.0001
73866692|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||||TWO_SIDED|95.0|-1.32|-0.41||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.41|-1.32|
73866693|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.07|||||TWO_SIDED|95.0|-1.53|-0.62||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.62|-1.53|
73973355|NCT06946888|147489451|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.744||||||This is the sixth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 6.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.744
74008388|NCT03627767|147566507|SUPERIORITY||LSM difference|-4.6|||<|0.0001|TWO_SIDED|95.0|-6.2|-2.9|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.9|-6.2|< 0.0001
74030673|NCT04964063|147615391|OTHER||Mean Difference (Final Values)|-18.84|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-19.96|-17.72|||ANOVA|||||-17.72|-19.96|<.0001
74030674|NCT04964063|147615393|OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.52|-1.56|||ANOVA|||||-1.56|-2.52|<.0001
74030675|NCT04964063|147615394|OTHER||Mean Difference (Final Values)|-3.69|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-4.17|-3.22|||ANOVA|||||-3.22|-4.17|<.0001
74030676|NCT04964063|147615395|OTHER||Mean Difference (Final Values)|-4.67|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-5.15|-4.2|||ANOVA|||||-4.20|-5.15|<.0001
74030677|NCT04964063|147615396|OTHER||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-5.72|-4.76|||ANOVA|||||-4.76|-5.72|<.0001
74030678|NCT04964063|147615397|OTHER||Mean Difference (Final Values)|-5.63|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-6.12|-5.14|||ANOVA|||||-5.14|-6.12|<.0001
74030679|NCT04964063|147615398|OTHER||Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-6.72|-5.77|||ANOVA|||||-5.77|-6.72|<.0001
74030680|NCT04964063|147615400|OTHER||Mean Difference (Final Values)|-5.25|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-6.06|-4.44|||ANOVA|||||-4.44|-6.06|<.0001
74030681|NCT04964063|147615401|OTHER||Mean Difference (Final Values)|-8.52|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-9.32|-7.72|||ANOVA|||||-7.72|-9.32|<.0001
74030682|NCT04964063|147615402|OTHER||Mean Difference (Final Values)|-10.55|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-11.35|-9.75|||ANOVA|||||-9.75|-11.35|<.0001
74030683|NCT04964063|147615403|OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-12.41|-10.79|||ANOVA|||||-10.79|-12.41|<.0001
74030684|NCT04964063|147615404|OTHER||Mean Difference (Final Values)|-12.63|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-13.45|-11.81|||ANOVA|||||-11.81|-13.45|<.0001
74030685|NCT04964063|147615405|OTHER||Mean Difference (Final Values)|-13.88|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-14.69|-13.08|||ANOVA|||||-13.08|-14.69|<.0001
74030686|NCT04964063|147615407|OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.43|-1.33|||ANOVA|||||-1.33|-2.43|<.0001
74030687|NCT04964063|147615408|OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-3.74|-2.65|||ANOVA|||||-2.65|-3.74|<.0001
74030688|NCT04964063|147615409|OTHER||Mean Difference (Final Values)|-3.98|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-4.53|-3.44|||ANOVA|||||-3.44|-4.53|<.0001
74030689|NCT04964063|147615410|OTHER||Mean Difference (Final Values)|-4.55|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-5.1|-4.0|||ANOVA|||||-4.00|-5.10|<.0001
74030690|NCT04964063|147615411|OTHER||Median Difference (Final Values)|-5.04|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-5.6|-4.48|||ANOVA|||||-4.48|-5.60|<.0001
74030691|NCT04964063|147615412|OTHER||Mean Difference (Final Values)|-6.07|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-6.62|-5.53|||ANOVA|||||-5.53|-6.62|<.0001
74030692|NCT04964063|147615414|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1091|TWO_SIDED|95.0|-0.12|0.01|||ANOVA|||||0.01|-0.12|0.1091
74030693|NCT04964063|147615415|OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.19|-0.06|||ANOVA|||||-0.06|-0.19|<.0001
74030694|NCT04964063|147615416|OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.23|-0.1|||ANOVA|||||-0.10|-0.23|<.0001
74030695|NCT04964063|147615417|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.11|||ANOVA|||||-0.11|-0.24|<.0001
74030696|NCT04964063|147615418|OTHER||Median Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.26|-0.13|||ANOVA|||||-0.13|-0.26|<.0001
74030697|NCT04964063|147615419|OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.31|-0.18|||ANOVA|||||-0.18|-0.31|<.0001
74030698|NCT04964063|147615421|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.95|-1.45|||ANOVA|||||-1.45|-1.95|<.0001
74030699|NCT04964063|147615422|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-2.94|-2.44|||ANOVA|||||-2.44|-2.94|<.0001
74030700|NCT04964063|147615423|OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-3.35|-2.84|||ANOVA|||||-2.84|-3.35|<.0001
74030701|NCT04964063|147615424|OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-3.69|-3.19|||ANOVA|||||-3.19|-3.69|<.0001
74030702|NCT04964063|147615425|OTHER||Median Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-4.06|-3.55|||ANOVA|||||-3.55|-4.06|<.0001
74030703|NCT04964063|147615426|OTHER||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-4.51|-4.0|||ANOVA|||||-4.00|-4.51|<.0001
73866694|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.05|||||TWO_SIDED|95.0|-1.51|-0.6||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.60|-1.51|
73866695|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|||||TWO_SIDED|95.0|-0.89|0.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.03|-0.89|
73866696|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04|||||TWO_SIDED|95.0|-1.5|-0.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-1.50|
73973356|NCT06946888|147489451|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.202||||||This is the seventh week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 7.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.202
73973357|NCT06946888|147489451|OTHER|A generalized estimating equation (GEE) model included group (intervention group vs. control group), week (categorical: 0-8), group × week interaction, and age as covariates. Robust (sandwich) standard errors were used. Regression coefficients (B), standard errors, Wald chi-squared statistics, 95% confidence intervals, and p-values for group × week comparisons are reported.||||||0.918||||||This is the eighth week of tracking data. A P value \< 0.05 indicated a statistically significant difference.|Generalized Estimating Equations, GEE|Repeated-measures GEE was used to examine the group × time interaction between week 0 and week 8.||Generalized estimating equations (GEE) were chosen over repeated-measures analysis of variance or generalized linear mixed models because they provide estimates of the population mean, are robust to correlated error specifications, can accommodate missing data under the MAR/MCAR assumptions, and do not require sphericity. All tests were two-tailed, with α = 0.05.||||0.918
73973358|NCT03367156|147489452|OTHER||Mean Difference (Final Values)|0.0||||0.48|TWO_SIDED|95.0|-0.8|0.7|||Linear Model|||||0.7|-0.8|0.48
73973359|NCT03367156|147489453|OTHER||Mean Difference (Final Values)|0.2|||>|0.99|TWO_SIDED|95.0|-0.7|1.0|||Linear Model|||||1|-0.7|>0.99
73973360|NCT03367156|147489454|OTHER||Mean Difference (Final Values)|0.4||||0.97|TWO_SIDED|95.0|-0.7|1.6|||Linear Model|||||1.6|-0.7|0.97
73973361|NCT03367156|147489455|OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|-0.8|1.0|||Linear Model|||||1.0|-0.8|0.78
73973362|NCT03367156|147489456|OTHER||Mean Difference (Final Values)|-0.5||||0.93|TWO_SIDED|95.0|-10.6|9.6|||Linear Model|||||9.6|-10.6|0.93
73973363|NCT03367156|147489457|OTHER||Mean Difference (Final Values)|0.6||||0.93|TWO_SIDED|95.0|-0.6|1.8|||Linear Model|||||1.8|-0.6|0.93
73973364|NCT03367156|147489458|OTHER||Mean Difference (Final Values)|0.1||||0.82|TWO_SIDED|95.0|-0.9|1.1|||Linear Model|||||1.1|-0.9|0.82
73973365|NCT03367156|147489459|OTHER||Mean Difference (Final Values)|-5.5||||0.38|TWO_SIDED|95.0|-17.9|6.9|||Linear Model|||||6.9|-17.9|0.38
73973366|NCT05879991|147489481|OTHER||Ratio of adjusted geometric means [%]|76.18|||||TWO_SIDED|90.0|70.21|82.65|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.9|"Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale.~The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale."||82.65|70.21|
73973367|NCT05879991|147489486|OTHER||Ratio of adjusted geometric means [%]|26.1|||||TWO_SIDED|90.0|22.12|30.79|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 16.0|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.||30.79|22.12|
73973368|NCT05879991|147489487|OTHER||Ratio of adjusted geometric means [%]|76.99|||||TWO_SIDED|90.0|70.92|83.59|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.9|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.||83.59|70.92|
73973369|NCT04084574|147489538|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_DEVIATION|13.5||0.3968|TWO_SIDED|95.0|-16.8|6.9||The threshold for statistical significance is p = 0.05|t-test, 2 sided||Between group difference in mean blood pressure change from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||6.9|-16.8|0.3968
74088943|NCT00486018|147731146|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.2815||95.0|-1.5|8.3|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.|||8.3|-1.5|0.2815
73866697|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|95.0|-1.0|-0.03||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-1.00|
73973370|NCT04084574|147489539|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.5||0.07926|TWO_SIDED|95.0|-0.33|0.44|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||0.44|-0.33|0.07926
73973371|NCT04084574|147489541|SUPERIORITY||Mean Difference (Net)|11.7|STANDARD_DEVIATION|59.3||0.0673|TWO_SIDED|95.0|-34.2|58.6|||t-test, 2 sided|||||58.6|-34.2|0.0673
73973372|NCT04084574|147489542|SUPERIORITY||Mean Difference (Net)|-10.7|STANDARD_DEVIATION|189.3||0.8821|TWO_SIDED|95.0|-157.8|136.4|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||136.4|-157.8|0.8821
73973373|NCT04084574|147489543|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|3.3||0.6479|TWO_SIDED|95.0|-2.0|3.1|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||3.1|-2.0|0.6479
73973374|NCT04084574|147489544|SUPERIORITY||Mean Difference (Net)|7.0|STANDARD_DEVIATION|21.8||0.4044|TWO_SIDED|95.0|-10.0|24.0|||t-test, 2 sided||Between group difference in mean blood pressure change from baseline for Behavioral Diet Counseling group minus Standard of Care group.|||24.0|-10.0|0.4044
73973375|NCT04084574|147489545|SUPERIORITY||Mean Difference (Net)|1.34|STANDARD_DEVIATION|2.91||0.2374|TWO_SIDED|95.0|-0.97|3.6|||t-test, 2 sided|||||3.60|-0.97|0.2374
73973376|NCT04084574|147489546|SUPERIORITY||Mean Difference (Net)|-2.69|STANDARD_DEVIATION|13.62||0.6188|TWO_SIDED|95.0|-13.71|8.33|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||8.33|-13.71|0.6188
73973377|NCT04084574|147489547|SUPERIORITY||Mean Difference (Net)|-1.39|STANDARD_DEVIATION|1.79||0.0546|TWO_SIDED|95.0|-2.82|0.03|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||0.03|-2.82|0.0546
73973378|NCT04084574|147489548|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.2||1|TWO_SIDED|95.0|-0.98|0.98|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||0.98|-0.98|1.00
73973379|NCT04084574|147489549|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|1.5||1|TWO_SIDED|95.0|-0.89|1.49|||t-test, 2 sided|||||1.49|-0.89|1.00
73973380|NCT02905331|147489553|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73973381|NCT02905331|147489554|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73973382|NCT02905331|147489559|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73973383|NCT01385202|147489563|SUPERIORITY_OR_OTHER_LEGACY||Primary effectiveness rate|70.2|||<|0.0001|TWO_SIDED|95.0|60.9|78.4||In the worst-case scenario analysis, over seventy-percent (70.2%, 80/114) of the primary effectiveness cohort (PEC) were free from documented symptomatic atrial tachyarrhythmias during their effectiveness evaluation period.|Fisher Exact|The lower bound of the 95% confidence intervals was 60.9%, significantly higher than the pre-determined performance goal of 50% (p\<0.0001).|The confidence intervals above are the 95% exact binomial confidence intervals.|The null hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be less than or equal to the pre-determined performance criterion of 50%. The alternative hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be greater than the pre-determined performance criterion of 50%.||78.4|60.9|<0.0001
73973384|NCT01385202|147489563|SUPERIORITY_OR_OTHER_LEGACY||Primary effectiveness rate|74.0|||||TWO_SIDED|95.0|66.0|82.0|||||The 95% confidence intervals above were calculated using the Kaplan-Meier (KM) method.|||82|66|
73973385|NCT04102111|147489573|OTHER||Least Squares Means|37.4||||0.288|TWO_SIDED|90.0|-21.0|95.8|||Mixed Model for Repeated Measures (MMRM)|||||95.8|-21.0|0.288
73866698|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|95.0|-1.4|-0.43||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.43|-1.40|
73973386|NCT04763772|147489588|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.2|TWO_SIDED|95.0|-14.0|4.8|||Regression, Linear|||||4.8|-14|0.2
73973387|NCT02510235|147489595|NON_INFERIORITY|"To declare non-inferiority between treatments, a change in the SANDE overall score of 12 mm was required, with an estimated standard deviation of 13 (approximately 70% of the mean at 28 ± 4 days after treatment).~The left inferior limits of confidence interval were determined and compared with the non-inferiority limit defined in the testing hypothesis.~Testing Hypothesis:~H0: meanHyaluronic - meanLubricin ≤ - 12~/ H1: meanHyaluronic - meanLubricin \> - 12"|Mean Difference (Final Values)|1.5|||||ONE_SIDED|95.0|-8.87||||Student t-test for unpaired data.|||Values at Day 28 ± 4 (end of treatment) for the SANDE overall VAS score were compared between treatment groups using a Student's t-test for unpaired data.|||-8.87|
73973388|NCT02510235|147489597|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.8226|TWO_SIDED|95.0|-7.66|6.11|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score||Foreign Body Sensation in the Study Eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||6.11|-7.66|0.8226
73973389|NCT02510235|147489597|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.3178|TWO_SIDED|95.0|-3.13|9.44|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Burning/Stinging in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||9.44|-3.13|0.3178
74030704|NCT01035606|147615428|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
74030705|NCT01035606|147615429|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
74030706|NCT01809262|147615430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0005||95.0|0.031|0.109|||ANCOVA|||||0.109|0.031|0.0005
74030707|NCT01809262|147615430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.06|0.138|||ANCOVA|||||0.138|0.060|<0.0001
73937715|NCT02071173|147406947|SUPERIORITY|Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|94.0|||||ONE_SIDED|97.5|92.0|||||||Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%|||92.0|
73937716|NCT02071173|147406948|SUPERIORITY|Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|91.1|||||ONE_SIDED|97.5|88.2|||||||Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%|||88.2|
73937717|NCT02071173|147406949|SUPERIORITY|Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|98.2|||||ONE_SIDED|95.0|97.5|||||||Ho: The Implant through 3-month lead-related complication-free rate ≤ 93%, Ha: The Implant through 3-month lead-related complication-free rate \> 93%|||97.5|
73937718|NCT02071173|147406950|SUPERIORITY|Single group test comparison to a performance goal of 94%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|99.3|||||ONE_SIDED|95.0|98.8|||||||Ho: The 3- through 24-month lead-related complication-free rate ≤ 94%, Ha: The 3- through 24-month lead-related complication-free rate \> 94%|||98.8|
73937719|NCT02071173|147406951|SUPERIORITY|Single group test comparison to a performance goal of 1.5 Volts. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.|Mean|0.56|||||ONE_SIDED|95.0||0.58||||||Ho: The 3-month mean PCT ≥ 1.5 Volts, Ha: The 3-month mean PCT \< 1.5 Volts||0.58||
73937720|NCT02071173|147406952|SUPERIORITY|Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|17.4|||||ONE_SIDED|95.0|16.7|||||||Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV|||16.7|
73937721|NCT02071173|147406953|SUPERIORITY|Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|16.1|||||ONE_SIDED|97.5|15.1|||||||Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV|||15.1|
73973390|NCT02510235|147489597|SUPERIORITY||Mean Difference (Final Values)|6.52||||0.0085|TWO_SIDED|95.0|1.74|11.3|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Itching in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||11.30|1.74|0.0085
73937722|NCT02071173|147406954|SUPERIORITY|Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|776.0|||||ONE_SIDED|97.5|753.0|||||||Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms|||753|
73937723|NCT02071173|147406955|SUPERIORITY|Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|805.0|||||ONE_SIDED|97.5|763.0|||||||Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms|||763|
73937724|NCT02071173|147406956|SUPERIORITY|Single group test comparison to a performance goal of 4.5 seconds. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.|Mean|3.14|||||ONE_SIDED|95.0||3.2||||||Ho: The mean detection time ≥ 4.5 seconds, Ha: The mean detection time \< 4.5 seconds||3.20||
73937725|NCT02071173|147406957|SUPERIORITY|Single group test comparison to a performance goal of 5 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|18.3|||||ONE_SIDED|95.0|6.2|||||||Ho: The 3-month mean sensed amplitude ≤ 5 mV, Ha: The 3-month mean sensed amplitude \> 5 mV|||6.2|
73937726|NCT02071173|147406958|OTHER|Two one-sided tests (TOST) were performed.|Mean|468.0|||||TWO_SIDED|90.0|463.0|472.0||||||Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω||472|463|
73937727|NCT02071173|147406959|OTHER|Two one-sided tests (TOST) were performed.|Mean|702.0|||||TWO_SIDED|90.0|659.0|744.0||||||Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω||744|659|
73937728|NCT02071173|147406960|SUPERIORITY|Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Percent|99.5|||||ONE_SIDED|95.0|98.4|||||||Ho: Percent of successful conversion ≤ 93%, Ha: Percent of successful conversion \> 93%|||98.4|
73937729|NCT04118348|147406974|SUPERIORITY||Odds Ratio (OR)|5.73|||<|0.001|TWO_SIDED|95.0|4.46|7.36|||Regression, Logistic||BPA+HMT is the numerator|Passive control was set as the reference group.||7.36|4.46|<.001
73937730|NCT04118348|147406974|SUPERIORITY||Odds Ratio (OR)|4.87|||<|0.001|TWO_SIDED|95.0|3.79|6.27|||Regression, Logistic||BPA-only is the numerator|Passive control was set as the reference group.||6.27|3.79|<.001
73937731|NCT04118348|147406974|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.19|||Regression, Logistic||HMT-only is the numerator|Passive control was set as the reference group.||2.19|1.28|<.001
73973391|NCT02510235|147489597|SUPERIORITY||Mean Difference (Final Values)|3.41||||0.3124|TWO_SIDED|95.0|-3.31|10.13|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Pain in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||10.13|-3.31|0.3124
74030708|NCT01809262|147615430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.074|0.152|||ANCOVA|||||0.152|0.074|<0.0001
73937732|NCT04118348|147406974|SUPERIORITY||Odds Ratio (OR)|3.43|||<|0.001|TWO_SIDED|95.0|2.73|4.29|||Regression, Logistic||BPA+HMT is the numerator|HMT was set as the reference group.||4.29|2.73|<.001
73937733|NCT04118348|147406974|SUPERIORITY||Odds Ratio (OR)|2.92|||<|0.001|TWO_SIDED|95.0|2.32|3.66|||Regression, Logistic||BPA-only is the numerator|HMT was set as the reference group.||3.66|2.32|<.001
73937734|NCT04118348|147406974|SUPERIORITY||Odds Ratio (OR)|1.17||||0.114|TWO_SIDED|95.0|0.96|1.43|||Regression, Logistic||BPA+HMT is the numerator|BPA was set as the reference group.||1.43|0.96|.114
73937735|NCT04118348|147406975|SUPERIORITY||Odds Ratio (OR)|2.9|||<|0.001|TWO_SIDED|95.0|2.02|4.15|||Regression, Logistic||BPA+HMT is the numerator|Passive control was set as the reference group.||4.15|2.02|<.001
73937736|NCT04118348|147406975|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.001|TWO_SIDED|95.0|1.57|3.3|||Regression, Logistic||BPA-only is the numerator|Passive control was set as the reference group.||3.30|1.57|<.001
73937737|NCT04118348|147406975|SUPERIORITY||Odds Ratio (OR)|1.54||||0.03|TWO_SIDED|95.0|1.04|2.27|||Regression, Logistic||HMT-only is the numerator|Passive control was set as the reference group.||2.27|1.04|.030
73937738|NCT04118348|147406975|SUPERIORITY||Odds Ratio (OR)|1.88|||<|0.001|TWO_SIDED|95.0|1.37|2.59|||Regression, Logistic||BPA+HMT is the numerator|HMT was set as the reference group.||2.59|1.37|<.001
73937739|NCT04118348|147406975|SUPERIORITY||Odds Ratio (OR)|1.48||||0.021|TWO_SIDED|95.0|1.06|2.06|||Regression, Logistic||BPA-only is the numerator|HMT was set as the reference group.||2.06|1.06|.021
73937740|NCT04118348|147406975|SUPERIORITY||Odds Ratio (OR)|1.27||||0.107|TWO_SIDED|95.0|0.95|1.71|||Regression, Logistic||BPA+HMT is the numerator|BPA was set as the reference group.||1.71|0.95|.107
73937741|NCT01059565|147406980|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|0.91||||0.663|TWO_SIDED|95.0|-3.24|5.06||"To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|Baseline was included as a covariate in this model.||"The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.~A sample size of 50 participants per group provided at least 80% power to detect an 8.5% difference in mean AUCave of relative change from baseline in FEV1 % predicted through Week 24 using a two-sided 0.05-level test, assuming a common standard deviation of 15."||5.06|-3.24|0.663
73937742|NCT01059565|147406981|SUPERIORITY_OR_OTHER|||||||0.4158||||||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|Negative binomial regression|The negative binomial regression model included an offset parameter which accounted for potential differing study durations due to discontinuations.||The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.4158
73937743|NCT01059565|147406982|SUPERIORITY_OR_OTHER||Difference in LSM|0.18||||0.939|TWO_SIDED|95.0|-4.43|1.78||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||1.78|-4.43|0.939
73937744|NCT01059565|147406983|SUPERIORITY_OR_OTHER||Difference in LSM|0.77||||0.711|TWO_SIDED|95.0|-3.33|4.86|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||4.86|-3.33|0.711
73937745|NCT01059565|147406984|SUPERIORITY_OR_OTHER||Difference in LSM|0.6||||0.762|TWO_SIDED|95.0|-3.3|4.49|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||4.49|-3.30|0.762
73937746|NCT01059565|147406985|SUPERIORITY_OR_OTHER||Difference in LSM|1.95||||0.553|TWO_SIDED|95.0|-4.54|8.44|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||8.44|-4.54|0.553
73937747|NCT01059565|147406986|SUPERIORITY_OR_OTHER||Difference in LSM|2.99||||0.17|TWO_SIDED|95.0|-1.2|7.28|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||7.28|-1.20|0.170
73937748|NCT01059565|147406987|SUPERIORITY_OR_OTHER||Difference in LSM|-2.57||||0.528|TWO_SIDED|95.0|-10.62|5.49|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||5.49|-10.62|0.528
74030709|NCT01809262|147615430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.08|0.158|||ANCOVA|||||0.158|0.080|<0.0001
74030710|NCT01809262|147615431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.077|0.139|||ANCOVA|||||0.139|0.077|<0.0001
74030711|NCT01809262|147615431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.124|0.186|||ANCOVA|||||0.186|0.124|<0.0001
74030712|NCT01809262|147615431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.13|0.192|||ANCOVA|||||0.192|0.130|<0.0001
74030713|NCT01809262|147615431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.161|0.223|||ANCOVA|||||0.223|0.161|<0.0001
74030714|NCT01809262|147615432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.068|0.131|||ANCOVA|||||0.131|0.068|<0.0001
74030715|NCT01809262|147615432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.107|0.171|||ANCOVA|||||0.171|0.107|<0.0001
73937749|NCT01059565|147406988|SUPERIORITY_OR_OTHER||Difference in LSM|3.62||||0.132|TWO_SIDED|95.0|-1.11|8.34|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||8.34|-1.11|0.132
73937750|NCT01059565|147406989|SUPERIORITY_OR_OTHER||Difference in LSM|0.14||||0.531|TWO_SIDED|95.0|-0.29|0.56|||Mixed Models Analysis|P-value was based on a Mixed-Effect Model Repeated Measure model that included terms for treatment, visit, baseline, and treatment/visit interaction.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||0.56|-0.29|0.531
73937751|NCT01059565|147406990|SUPERIORITY_OR_OTHER||Difference in LSM|0.93||||0.232|TWO_SIDED|95.0|-0.62|2.48|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||2.48|-0.62|0.232
73937752|NCT01059565|147406991|SUPERIORITY_OR_OTHER|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.103
73937753|NCT01059565|147406992|SUPERIORITY_OR_OTHER|||||||0.646|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.646
73937754|NCT01059565|147406993|SUPERIORITY_OR_OTHER|||||||0.284|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.284
73937755|NCT00574587|147406995|SUPERIORITY_OR_OTHER_LEGACY||95% Confidence interval|54.0|||<|0.1|TWO_SIDED|20.0|34.0|74.0|||Simon's Mimimax 2-stage design|||||74|34|<0.10
74008389|NCT03627767|147566507|SUPERIORITY||LSM difference|-6.7|||<|0.0001|TWO_SIDED|95.0|-8.3|-5.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.1|-8.3|< 0.0001
74088944|NCT00486018|147731147|SUPERIORITY_OR_OTHER||Difference in percentage|45.5|||<|0.0001||95.0|36.0|55.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||55.0|36.0|<0.0001
74088945|NCT00486018|147731147|SUPERIORITY_OR_OTHER||Difference in percentage|40.1|||<|0.0001||95.0|29.9|50.2|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||50.2|29.9|<0.0001
73937756|NCT02647359|147407113|OTHER||Least Square (LS) Mean Difference|10.76||||0.4868|TWO_SIDED|95.0|-21.914|43.434||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with age and baseline Maximum Reading Speed (both eyes) as covariates, and treatment as a factor.||43.434|-21.914|0.4868
73937757|NCT00511004|147407124|SUPERIORITY_OR_OTHER||||||<|0.2|TWO_SIDED|||||Adjusted for multiple comparisons|Fisher Exact|||||||<0.2
73937758|NCT00511004|147407125|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Fisher Exact|||||||0.9
73937759|NCT04818346|147407138|SUPERIORITY||Least squares mean difference|-21.41|STANDARD_ERROR_OF_MEAN|6.62||0.0015|TWO_SIDED|95.0|-34.49|-8.32|||Mixed Model Repeated Measures (MMRM)|||||-8.32|-34.49|0.0015
73937760|NCT04818346|147407138|SUPERIORITY||Least squares mean difference|-20.07|STANDARD_ERROR_OF_MEAN|6.86||0.004|TWO_SIDED|95.0|-33.63|-6.51|||MMRM|||||-6.51|-33.63|0.0040
73937761|NCT04818346|147407138|SUPERIORITY||Least squares mean difference|-18.02|STANDARD_ERROR_OF_MEAN|6.77||0.0086|TWO_SIDED|95.0|-31.4|-4.64|||MMRM|||||-4.64|-31.40|0.0086
73937762|NCT04818346|147407139|SUPERIORITY||Odds Ratio (OR)|4.3||||0.3574|TWO_SIDED|95.0|0.398|220.998|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||220.998|0.398|0.3574
73937763|NCT04818346|147407139|SUPERIORITY||Odds Ratio (OR)|5.5||||0.1992|TWO_SIDED|95.0|0.573|273.479|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||273.479|0.573|0.1992
73937764|NCT04818346|147407139|SUPERIORITY||Odds Ratio (OR)|2.1||||0.9913|TWO_SIDED|95.0|0.103|126.386|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||126.386|0.103|0.9913
73937765|NCT01362140|147407145|SUPERIORITY_OR_OTHER|||||||0.008|||||||Chi-squared|||"The primary hypothesis to be tested was that the percentage of participants with at least~1 RBC transfusion from week 5 to the EOTP was lower in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if the incidence of RBC transfusion in the darbepoetin alfa group was lower and had a p-value \< 0.05 from a 2-sided Chi-square test."||||0.008
73937766|NCT01362140|147407146|SUPERIORITY_OR_OTHER|||||||0.017|||||||Cochran-Mantel-Haenszel|The overall 2-sided CMH test with IPSS score as stratification factor.||If the primary hypothesis was confirmed, the secondary hypothesis to be tested was that the percentage of participants achieving an IWG erythroid response during the 24-week double-blind treatment period was greater in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if erythroid response was higher in the darbepoetin alfa group and the p-value was \< 0.05 from a 2-sided Cochran-Mantel-Haenszel test using the IPSS as a stratification factor.||||0.017
73937767|NCT03069482|147407211|SUPERIORITY||Slope|1.063|STANDARD_DEVIATION|3.377|=|0.754|TWO_SIDED||||||ANOVA|||||||=0.754
73937768|NCT03069482|147407212|SUPERIORITY||Risk Ratio (RR)|2.103|STANDARD_DEVIATION|0.369||0.044|TWO_SIDED|95.0|1.2|2.6|||Mixed Models Analysis|Zero inflated negative binomial mixed methods regression.||||2.6|1.2|0.044
73937769|NCT03069482|147407213|OTHER||Percent accrual relative to target N|102.0|||||TWO_SIDED||||||||||The goal of this outcome was to determine whether the trial could reach its enrollment target (90 participants).|||
73937770|NCT03069482|147407214|OTHER||Percent retention relative to target|98.3|||||TWO_SIDED||||||||||We calculated the percent of retained participants relative to the retention target (N = 62)|||
73937771|NCT03069482|147407215|OTHER||Percent of respondents|58.0|||||TWO_SIDED|||||||||||||
73937772|NCT03069482|147407217|SUPERIORITY||Trimmed mean difference|8.29574|STANDARD_ERROR_OF_MEAN|2.11||0.046|TWO_SIDED|95.0|0.138|16.453|||Yuen's trimmed mean t-test|||||16.453|0.138|0.046
73937773|NCT03069482|147407218|SUPERIORITY||Trimmed mean difference|7.79514|STANDARD_ERROR_OF_MEAN|2.16||0.109|TWO_SIDED|95.0|-1.867|17.457|||Yuen's trimmed means t-test|||||17.457|-1.867|0.109
73937774|NCT03069482|147407219|SUPERIORITY||Trimmed mean difference|2.22222|STANDARD_ERROR_OF_MEAN|1.75||0.50537|TWO_SIDED|95.0|-4.492|8.943|||Yuen's trimmed means t-test|||||8.943|-4.492|0.50537
73937775|NCT03069482|147407220|SUPERIORITY||Trimmed mean difference|5.83333|STANDARD_ERROR_OF_MEAN|2.3||0.27411|TWO_SIDED|95.0|-4.88|16.54|||Yuen's trimmed means t-test|||||16.54|-4.88|0.27411
73937776|NCT00791765|147407266|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||van Elteren's test|Stratified by baseline body mass index group||||||<0.0001
73937777|NCT00791765|147407267|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by baseline body mass index group||||||<0.0001
73937778|NCT00791765|147407268|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||2-sided pairwise van Elteren's test|Stratified by baseline body mass index group||Comparison of week 24 outcome to week 12 outcome (see Outcome Measure 1)||||<0.0001
73937779|NCT00791765|147407269|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided test with modified ridit scores stratified by baseline body mass index group||||||<0.0001
74008390|NCT03627767|147566507|SUPERIORITY||LSM difference|-2.1|||||TWO_SIDED|95.0|-3.3|-0.9||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-3.3|
73937780|NCT00156065|147407289|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.8619||||||95.0|0.6912|0.9644|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9644|0.6912|
73937781|NCT00156065|147407289|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.8834||||||95.0|0.7744|0.955|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9550|0.7744|
73937782|NCT00156065|147407289|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.9376||||||95.0|0.7631|0.9952|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9952|0.7631|
73937783|NCT01292603|147407292|NON_INFERIORITY_OR_EQUIVALENCE|A standard non-inferiority margin of 0.8 for the ratio of Ctrough was used. The non-inferiority limit corresponds to a maximal 20 percent (%) loss in Ctrough which is considered acceptable given the high variability and range of Ctrough data, with an 80% power and a one-sided alpha of 0.05.|Adjusted geometric mean ratio|1.533|||||TWO_SIDED|90.0|1.269|1.852|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.852|1.269|
73937784|NCT01292603|147407293|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.102|||||TWO_SIDED|90.0|0.979|1.242|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.242|0.979|
73937785|NCT01292603|147407294|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.719|||||TWO_SIDED|90.0|0.653|0.792|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||0.792|0.653|
73937786|NCT01292603|147407295|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|14.884|||||TWO_SIDED|90.0|11.215|19.755|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||19.755|11.215|
73937787|NCT01292603|147407296|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.895|1.139|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.139|0.895|
73937788|NCT03586648|147407319|SUPERIORITY|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than 32 points.|Least-square Mean|39.3|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|32.7|45.9|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||Data only from the first period will be used if period effect is significant.||45.9|32.7|
73937789|NCT03586648|147407320|NON_INFERIORITY|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than -5 points.|Least-square Mean Difference|-11.5|STANDARD_ERROR_OF_MEAN|4.14|||TWO_SIDED|95.0|-19.7|-3.3|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control.|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.||-3.3|-19.7|
73937790|NCT00907153|147407321|SUPERIORITY||Mean Difference (Net)|-0.017||||0.05|TWO_SIDED|95.0|-0.034|0.0|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||-0.000|-0.034|0.05
73937791|NCT00907153|147407322|SUPERIORITY||Mean Difference (Net)|-1.14||||0.62|TWO_SIDED|95.0|-5.89|3.62|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||3.62|-5.89|0.62
73937792|NCT00907153|147407323|SUPERIORITY||Mean Difference (Net)|-3.65||||0.48|TWO_SIDED|95.0|-14.32|7.02|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||7.02|-14.32|0.48
73937793|NCT00907153|147407324|SUPERIORITY||Mean Difference (Net)|-6.51||||0.02|TWO_SIDED|95.0|-12.07|-0.96|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||-0.96|-12.07|0.02
73937794|NCT00907153|147407325|SUPERIORITY||Mean Difference (Net)|6.28||||0.22|TWO_SIDED|95.0|-3.97|16.54|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||16.54|-3.97|0.22
73937795|NCT00907153|147407326|SUPERIORITY||Mean Difference (Net)|13.84||||0.33|TWO_SIDED|95.0|-210.29|37.98|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||37.98|-210.29|0.33
73937796|NCT00907153|147407327|SUPERIORITY||Mean Difference (Net)|-12.8||||0.39|TWO_SIDED|95.0|-42.94|17.34|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||17.34|-42.94|0.39
73937797|NCT00907153|147407328|SUPERIORITY||Mean Difference (Net)|-75.08||||0.09|TWO_SIDED|95.0|-161.9|11.78|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||11.78|-161.9|0.09
73937798|NCT00907153|147407329|SUPERIORITY||Mean Difference (Net)|0.73||||0.96|TWO_SIDED|95.0|-32.59|34.06|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||34.06|-32.59|0.96
73937799|NCT00907153|147407330|SUPERIORITY||Mean Difference (Net)|3.08||||0.21|TWO_SIDED|95.0|-1.84|7.99|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||7.99|-1.84|0.21
73937800|NCT00907153|147407331|SUPERIORITY||Mean Difference (Net)|0.11||||0.99|TWO_SIDED|95.0|-24.43|24.64|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||24.64|-24.43|0.99
73937801|NCT00907153|147407332|SUPERIORITY||Median Difference (Net)|-1.93||||0.62|TWO_SIDED|95.0|-10.12|6.26|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||6.26|-10.12|0.62
73937802|NCT00907153|147407333|SUPERIORITY||Mean Difference (Net)|0.28||||0.98|TWO_SIDED|95.0|-20.29|20.85|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||20.85|-20.29|0.98
73937803|NCT00907153|147407334|SUPERIORITY||Mean Difference (Net)|10.24||||0.64|TWO_SIDED|95.0|-34.61|55.08|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||55.08|-34.61|0.64
73937804|NCT00907153|147407335|SUPERIORITY||Mean Difference (Net)|0.88||||0.88|TWO_SIDED|95.0|-22.81|8.51|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||8.51|-22.81|0.88
73937805|NCT00907153|147407336|SUPERIORITY||Mean Difference (Net)|-3.15||||0.25|TWO_SIDED|95.0|-8.7|2.41|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||2.41|-8.70|0.25
73973392|NCT02510235|147489597|SUPERIORITY||Mean Difference (Final Values)|6.76||||0.0377|TWO_SIDED|95.0|0.4|13.12|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Sticky feeling in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||13.12|0.40|0.0377
74030716|NCT01809262|147615432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.122|0.185|||ANCOVA|||||0.185|0.122|<0.0001
73937806|NCT00907153|147407337|SUPERIORITY||Mean Difference (Net)|44.31|||<|0.001|TWO_SIDED|95.0|27.13|61.48|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||61.48|27.13|<0.001
73937807|NCT00907153|147407338|SUPERIORITY||Mean Difference (Net)|1.56||||0.38|TWO_SIDED|95.0|-2.08|5.2|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||5.20|-2.08|0.38
73937808|NCT00907153|147407339|SUPERIORITY||Mean Difference (Net)|-7.84||||0.46|TWO_SIDED|95.0|-29.34|13.67|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||13.67|-29.34|0.46
73937809|NCT03147248|147407341|NON_INFERIORITY|The non-inferiority was to be concluded if the lower limit of the two-sided 95% confidence interval (CI) for the difference in the mean change from baseline of DAS28 (CRP) at Week 22 was greater that the pre-specified non-inferiority margin of -0.6.|Difference of Least square mean|0.27|||||TWO_SIDED|95.0|0.02|0.52|||||The least squares means and standard errors, estimate of treatment difference (CT-P13 SC 120 mg - CT-P13 IV 3 mg/kg), and 2-sided 95% CI obtained from the ANCOVA model.|Primary efficacy analysis were analyzed using an ANCOVA considering the treatment as fixed effect and country, serum CRP concentration at Week 2 (≤0.6 mg/dL vs. \>0.6 mg/dL), and body weight at Week 6 (≤100 kg vs. \>100 kg) as covariates.||0.52|0.02|
73937810|NCT02388724|147407349|NON_INFERIORITY|If the lower bound of the 95% confidence intervals of the difference was more than -10% (non-inferiority margin), non-inferiority for Vonoprazan relative to Lansoprazole was declared.|Difference in percentages|1.1|||||TWO_SIDED|95.0|-3.822|6.087||||||||6.087|-3.822|
73937811|NCT02388724|147407350|SUPERIORITY||Difference in percentages|7.2|||||TWO_SIDED|95.0|-1.054|15.371||||||2 Weeks||15.371|-1.054|
73937812|NCT02388724|147407350|SUPERIORITY||Difference in percentages|1.8|||||TWO_SIDED|95.0|-4.763|8.395||||||4 Weeks||8.395|-4.763|
73937813|NCT02605954|147407358|NON_INFERIORITY|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the ABC/3TC+3rd Agent group at Week 24, the lower limit of the observed one sided 97.5% confidence interval was expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with \> 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 24.|Difference in Percentages|-4.4||||0.15|TWO_SIDED|95.0|-9.4|1.9|||Fisher Exact|||||1.9|-9.4|0.15
73937814|NCT02605954|147407359|NON_INFERIORITY|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the delayed switch group at Week 12, the lower limit of the observed one sided 97.5% confidence interval will be expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with \> 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 12.|Difference in Percentages|-3.8||||0.17|TWO_SIDED|95.0|-8.3|1.6|||Fisher Exact|||||1.6|-8.3|0.17
73937815|NCT02605954|147407361|OTHER||Difference in least square mean|-36.0||||0.11|TWO_SIDED|95.0|-80.0|9.0|||ANOVA|||||9|-80|0.11
73937816|NCT03214367|147407363|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|-0.08||||0.06|TWO_SIDED|95.0|-0.16|0.0|||Mixed Models Analysis|||||0.00|-0.16|0.060
73937817|NCT03214367|147407363|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.13||||0.003|TWO_SIDED|95.0|0.04|0.22|||Mixed Models Analysis|||||0.22|0.04|0.003
73937818|NCT03214367|147407364|SUPERIORITY||LS Mean Difference|-27.9|||<|0.001|TWO_SIDED|95.0|-35.3|-20.6|||ANCOVA|||||-20.6|-35.3|<0.001
73937819|NCT03214367|147407364|SUPERIORITY||LS Mean Difference|13.2||||0.002|TWO_SIDED|95.0|5.0|21.4|||ANCOVA|||||21.4|5.0|0.002
73937820|NCT03214367|147407365|SUPERIORITY||LS Mean Difference|-31.2|||<|0.001|TWO_SIDED|95.0|-41.1|-21.2|||ANCOVA|||||-21.2|-41.1|<0.001
73937821|NCT03214367|147407365|SUPERIORITY||LS Mean Difference|-6.7||||0.235|TWO_SIDED|95.0|-17.6|4.3|||ANCOVA|||||4.3|-17.6|0.235
73937822|NCT03214367|147407374|SUPERIORITY||LS Mean Difference|-0.06||||0.184|TWO_SIDED|95.0|-0.16|0.03|||Mixed Models Analysis|||||0.03|-0.16|0.184
73937823|NCT03508843|147407375|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<.001
73937824|NCT03508843|147407376|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<.001
73937825|NCT03508843|147407377|SUPERIORITY||||||>|0.05|||||||McNemar|||||||>.05
73866699|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|||||TWO_SIDED|95.0|-1.77|-0.8||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.80|-1.77|
73937826|NCT03555396|147407378|SUPERIORITY||Mean Difference (Final Values)|-3.54||||0.483|TWO_SIDED|95.0|-13.53|6.46|||t-test, 2 sided|||||6.46|-13.53|0.483
73937827|NCT03555396|147407379|SUPERIORITY|||||||0.637|||||||Chi-squared|||||||0.637
73937828|NCT03555396|147407380|SUPERIORITY||Mean Difference (Net)|9.54||||0.037|TWO_SIDED|95.0|0.59|18.49||Difference in mean change in adherence from baseline to 6 month follow-up between individuals in the intervention and control arms.|Mixed Models Analysis|Multilevel linear mixed model with random effects (dyad \& intercept); adjusting for participant age, sex, baseline adherence, and partner HIV status||||18.49|0.59|0.037
73937829|NCT03555396|147407381|SUPERIORITY|||||||0.621|||||||Chi-squared|Fisher's Exact Test used for small sample sizes||||||0.621
73937830|NCT01552213|147407382|SUPERIORITY||Risk Ratio (RR)|0.8||||0.32|TWO_SIDED|95.0|0.53|1.24|||Chi-squared|||||1.24|0.53|0.32
73937831|NCT01552213|147407383|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
73937832|NCT01552213|147407384|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
74008391|NCT03627767|147566507|SUPERIORITY||LSM difference|-2.6|||=|0.0082|TWO_SIDED|95.0|-4.5|-0.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-4.5|= 0.0082
73937833|NCT01552213|147407385|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
73937834|NCT01552213|147407386|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
73937835|NCT01552213|147407387|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
73937836|NCT01552213|147407388|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
73937837|NCT01552213|147407389|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
73937838|NCT01552213|147407390|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
73937839|NCT01552213|147407391|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
73937840|NCT01552213|147407392|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
73937841|NCT01552213|147407393|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
73937842|NCT01552213|147407394|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73937843|NCT01552213|147407395|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
73937844|NCT04256733|147407397|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||.23
73937845|NCT04256733|147407398|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|||||||.57
73937846|NCT04256733|147407399|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
73937847|NCT04542343|147407400|OTHER||Mean Difference (Net)|3.0|||<|0.01|TWO_SIDED|95.0|2.246|3.754|||t-test, 2 sided|||||3.75400|2.24600|<0.01
73937848|NCT04542343|147407401|OTHER||Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|95.0|-4.256785|-2.343215|||t-test, 2 sided|||||-2.343215|-4.256785|<0.001
73937849|NCT04542343|147407406|OTHER||Mean Difference (Net)|-0.21818|||<|0.01|TWO_SIDED|95.0|-0.36828|-0.06809|||t-test, 2 sided|||||-0.06809|-0.36828|<0.01
73937850|NCT04542343|147407407|OTHER||Mean Difference (Net)|0.05623|STANDARD_ERROR_OF_MEAN|0.026|<|0.05|TWO_SIDED|95.0|0.00459|0.10788|||t-test, 2 sided|||||0.10788|0.00459|<0.05
73937851|NCT01816594|147407410|SUPERIORITY|||||||0.811|||||||Fisher Exact|(one-sided)||All participantss||||0.811
73937852|NCT01816594|147407411|SUPERIORITY|||||||0.83|||||||Fisher Exact|(one-sided)||wild type cohort||||0.830
73937853|NCT01816594|147407412|SUPERIORITY|||||||0.786|||||||Fisher Exact|(one-sided)||mutant cohort||||0.786
73937854|NCT01816594|147407413|SUPERIORITY|||||||0.286|||||||Fisher Exact|(one-sided)||All participants||||0.286
73937855|NCT01816594|147407414|SUPERIORITY|||||||0.177|||||||Fisher Exact|(one-sided)||wild type cohort||||0.177
73937856|NCT01816594|147407415|SUPERIORITY|||||||0.929|||||||Fisher Exact|(one-sided)||mutant cohort||||0.929
73937857|NCT01816594|147407416|SUPERIORITY|||||||0.811|||||||Fisher Exact|(one-sided)||||||0.811
73937858|NCT01816594|147407417|SUPERIORITY|||||||0.84|||||||Fisher Exact|(one-sided)||||||0.840
73937859|NCT01816594|147407418|SUPERIORITY|||||||0.724|||||||Fisher Exact|(one-sided)||||||0.724
73937860|NCT01816594|147407419|SUPERIORITY|||||||0.964|||||||Fisher Exact|(one-sided)||All participants||||0.964
73937861|NCT01816594|147407420|SUPERIORITY|||||||0.546|||||||Fisher Exact|(one-sided)||For ER+ participants - pCR||||0.546
73937862|NCT01816594|147407421|SUPERIORITY|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - pCR||||0.949
73937863|NCT01816594|147407422|SUPERIORITY|||||||0.053|||||||Fisher Exact|(one-sided)||For ER+ participants - ORR||||0.053
73937864|NCT01816594|147407423|SUPERIORITY|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - ORR||||0.949
73937865|NCT01816594|147407424|SUPERIORITY|||||||0.666|||||||Fisher Exact|(one-sided)||||||0.666
73937866|NCT01816594|147407425|SUPERIORITY|||||||0.803|||||||Fisher Exact|(one-sided)||||||0.803
73937867|NCT03905655|147407426|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
73937868|NCT03905655|147407426|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
73937869|NCT03905655|147407426|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
73937870|NCT03905655|147407427|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73937871|NCT03905655|147407427|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73937872|NCT03905655|147407427|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73937873|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
73937874|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
73937875|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 2 values||||1.000
73937876|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 4 values||||1.000
74030717|NCT01809262|147615432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.152|0.215|||ANCOVA|||||0.215|0.152|<0.0001
74030718|NCT01809262|147615433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.056|0.117|||ANCOVA|||||0.117|0.056|<0.0001
74030719|NCT01809262|147615433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.087|0.148|||ANCOVA|||||0.148|0.087|<0.0001
74030720|NCT01809262|147615433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.107|0.168|||ANCOVA|||||0.168|0.107|<0.0001
74030721|NCT01809262|147615433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.132|0.193|||ANCOVA|||||0.193|0.132|<0.0001
74030722|NCT01809262|147615434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.041|0.108|||ANCOVA|||||0.108|0.041|<0.0001
74030723|NCT01809262|147615434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.096|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.062|0.13|||ANCOVA|||||0.130|0.062|<0.0001
74030724|NCT01809262|147615434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.089|0.156|||ANCOVA|||||0.156|0.089|<0.0001
74030725|NCT01809262|147615434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.107|0.174|||ANCOVA|||||0.174|0.107|<0.0001
73937877|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 8 values||||1.000
73937878|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
73937879|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
73937880|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 2 values||||1.000
73937881|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 4 values||||1.000
73937882|NCT03905655|147407428|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.001
73937883|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
73937884|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
73937885|NCT03905655|147407428|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Comparison of Week 2 values||||<0.001
73937886|NCT03905655|147407428|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.002
73937887|NCT03905655|147407428|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 8 values||||1.000
73937888|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
73937889|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
73937890|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
73937891|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
73937892|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
73937893|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
73937894|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
73937895|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
73937896|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
73937897|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
73937898|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
73937899|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
73937900|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
73937901|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
73937902|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
73937903|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
73937904|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
73937905|NCT03905655|147407429|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
73937906|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
73937907|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
73937908|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
73937909|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
73937910|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
73937911|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
73937912|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
73937913|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
73937914|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
73937915|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
73937916|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
73937917|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
73937918|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
73937919|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
73937920|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
73937921|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
73937922|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
73937923|NCT03905655|147407430|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
73866700|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.69|-0.72||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.72|-1.69|
73937924|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
74088946|NCT00486018|147731148|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-148.7|||<|0.0001||95.0|-183.6|-113.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-113.8|-183.6|<0.0001
73866701|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.98|-0.01||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-0.98|
73866702|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-1.69|-0.73||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.73|-1.69|
73866703|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|95.0|0.04|0.78||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.78|0.04|
73937925|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
73937926|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
73937927|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
73937928|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
73937929|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
73937930|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
73937931|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
73937932|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
73937933|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
73937934|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
73937935|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
73937936|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
73937937|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
73937938|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
73937939|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
73937940|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
73937941|NCT03905655|147407431|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
73937942|NCT03905655|147407432|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.006
73937943|NCT03905655|147407432|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.003
73937944|NCT03905655|147407432|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.004
73937945|NCT03905655|147407432|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.006
73937946|NCT03905655|147407432|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.002
73937947|NCT03905655|147407432|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.141
73937948|NCT03905655|147407432|SUPERIORITY|||||||0.081|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.081
73937949|NCT03905655|147407432|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.160
73937950|NCT03905655|147407432|SUPERIORITY|||||||0.184|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.184
73937951|NCT03905655|147407432|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.046
73937952|NCT03905655|147407432|SUPERIORITY|||||||0.379|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.379
73937953|NCT03905655|147407432|SUPERIORITY|||||||0.308|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.308
73937954|NCT03905655|147407432|SUPERIORITY|||||||0.794|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.794
73937955|NCT03905655|147407432|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.297
73937956|NCT03905655|147407432|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.007
73937957|NCT03905655|147407433|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
73937958|NCT03905655|147407433|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
73937959|NCT03905655|147407433|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
73937960|NCT02566031|147407434|SUPERIORITY||Mean Difference (Net)|0.05||||0.0129|TWO_SIDED|95.0|0.011|0.093|||ANCOVA|||||0.093|0.011|0.0129
73937961|NCT02566031|147407435|SUPERIORITY||Mean Difference (Net)|0.06||||0.0058|TWO_SIDED|95.0|0.017|0.098|||ANCOVA|||-45 min||0.098|0.017|0.0058
73937962|NCT02566031|147407435|SUPERIORITY||Mean Difference (Net)|0.05||||0.0161|TWO_SIDED|95.0|0.009|0.091|||ANCOVA|||-15min||0.091|0.009|0.0161
73937963|NCT02566031|147407436|SUPERIORITY||Mean Difference (Net)|0.31||||0.0767|TWO_SIDED|95.0|-0.033|0.646|||ANCOVA|||||0.646|-0.033|0.0767
73937964|NCT02566031|147407437|SUPERIORITY||Mean Difference (Net)|-0.81||||0.1008|TWO_SIDED|95.0|-1.77|0.16|||ANCOVA|||||0.16|-1.77|0.1008
73937965|NCT00121238|147407443|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
73937966|NCT05585307|147407501|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73866704|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.29|0.44||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.29|
73866705|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.35|0.38||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.38|-0.35|
73866706|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.65|0.08||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.08|-0.65|
73973393|NCT02510235|147489597|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.5321|TWO_SIDED|95.0|-4.62|8.83|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Blurred vision in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||8.83|-4.62|0.5321
73937967|NCT05585307|147407501|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937968|NCT05585307|147407501|SUPERIORITY|||||||0.0013||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||0.0013
73937969|NCT05585307|147407501|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937970|NCT05585307|147407501|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937971|NCT05585307|147407501|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73973394|NCT02510235|147489597|SUPERIORITY||Mean Difference (Final Values)|2.32||||0.579|TWO_SIDED|95.0|-6.04|10.68|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Photophobia in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||10.68|-6.04|0.5790
74030726|NCT01809262|147615435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.084|0.158|||ANCOVA|||||0.158|0.084|<0.0001
74030727|NCT01809262|147615435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.129|0.203|||ANCOVA|||||0.203|0.129|<0.0001
73937972|NCT05585307|147407501|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937973|NCT05585307|147407501|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937974|NCT05585307|147407502|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937975|NCT05585307|147407502|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937976|NCT05585307|147407502|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937977|NCT05585307|147407502|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937978|NCT05585307|147407502|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937979|NCT05585307|147407502|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937980|NCT05585307|147407502|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937981|NCT05585307|147407502|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
73937982|NCT04420221|147407548|SUPERIORITY||Vaccine Efficacy (VE)|-74.76||||0.8042||92.5|-680.61|36.62|||Log Rank|One-sided Group Sequential Design with non-binding beta, yielding two CIs based on cumulative alpha (92.5%) and beta (80.5%) spending|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||36.62|-680.61|0.8042
73937983|NCT04420221|147407549|OTHER||Vaccine Efficacy (VE)|-38.09|||||TWO_SIDED|95.0|-245.77|40.86|||||Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||40.86|-245.77|
73937984|NCT04420221|147407550|OTHER||Vaccine Efficacy (VE)|-75.52|||||TWO_SIDED|95.0|-295.41|17.46|||||Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||17.46|-295.41|
73937985|NCT00688636|147407601|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Fisher Exact|||||||.0005
73937986|NCT04053764|147407606|SUPERIORITY||Odds Ratio (OR)|1.94|||||TWO_SIDED|95.0|0.53|7.14||||||||7.14|0.53|
73937987|NCT04053764|147407608|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.23|2.31||||||||2.31|0.23|
73937988|NCT04053764|147407609|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.29|3.02||||||PCR Improvement||3.02|0.29|
73937989|NCT04053764|147407609|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.18|3.2||||||Stable PCR||3.20|0.18|
73937990|NCT04053764|147407610|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-5.53|4.65||||||From baseline to 3 months||4.65|-5.53|
73937991|NCT04053764|147407610|SUPERIORITY||Mean Difference (Final Values)|4.69|STANDARD_ERROR_OF_MEAN|3.32|||TWO_SIDED|95.0|-2.02|11.4||||||From baseline to 6 months||11.40|-2.02|
73937992|NCT04053764|147407610|SUPERIORITY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-3.58|11.68||||||From baseline to 9 months||11.68|-3.58|
73937993|NCT04053764|147407610|SUPERIORITY||Mean Difference (Final Values)|5.19|STANDARD_ERROR_OF_MEAN|4.17|||TWO_SIDED|95.0|-3.28|13.67||||||From baseline to 12 months||13.67|-3.28|
73937994|NCT04053764|147407613|SUPERIORITY||Odds Ratio (OR)|0.32|||||TWO_SIDED|95.0|0.09|1.21||||||||1.21|0.09|
73937995|NCT02935062|147407618|SUPERIORITY|||||||0.001|||||||t-test, 1 sided|||||||0.001
73937996|NCT02935062|147407619|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|||||||0.011
73937997|NCT01581281|147407669|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2636|TWO_SIDED|98.3|0.34|1.48||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons, the Bonferroni corrected level of significance is 0.017 (= 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for amitriptyline relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.48|0.34|0.2636
73937998|NCT01581281|147407669|SUPERIORITY||Odds Ratio (OR)|0.81||||0.4821|TWO_SIDED|98.3|0.39|1.68||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.68|0.39|0.4821
73937999|NCT01581281|147407669|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6107|TWO_SIDED|98.3|0.49|1.59||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to amitriptyline. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.59|0.49|0.6107
73938000|NCT01581281|147407670|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.9137|TWO_SIDED|95.0|-6.64|5.95|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||5.95|-6.64|0.9137
73938001|NCT01581281|147407670|SUPERIORITY||Median Difference (Final Values)|-4.84||||0.1331|TWO_SIDED|95.0|-11.16|1.49|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.49|-11.16|0.1331
74030728|NCT01809262|147615435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.214|||ANCOVA|||||0.214|0.139|<0.0001
73938002|NCT01581281|147407670|SUPERIORITY||Mean Difference (Final Values)|4.49||||0.1011|TWO_SIDED|95.0|-0.88|9.87|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||9.87|-0.88|0.1011
73938003|NCT01581281|147407671|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.3553|TWO_SIDED|98.3|-2.59|1.15||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.15|-2.59|0.3553
73938004|NCT01581281|147407671|SUPERIORITY||Median Difference (Final Values)|-0.64||||0.4143|TWO_SIDED|98.3|-2.52|1.24||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.24|-2.52|0.4143
73938005|NCT01581281|147407671|SUPERIORITY||Median Difference (Final Values)|-0.08||||0.9038|TWO_SIDED|98.3|-1.68|1.52||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.52|-1.68|0.9038
74030729|NCT01809262|147615435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.176|0.25|||ANCOVA|||||0.250|0.176|<0.0001
74030730|NCT01809262|147615436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.306|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.21|0.402|||ANCOVA|||||0.402|0.210|<0.0001
74030731|NCT01809262|147615436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.355|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.258|0.452|||ANCOVA|||||0.452|0.258|<0.0001
73973395|NCT02510235|147489597|SUPERIORITY||Mean Difference (Final Values)|16.13||||0.3383|TWO_SIDED|95.0|-17.41|49.68|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Total ocular tolerability score in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||49.68|-17.41|0.3383
73973396|NCT02510235|147489598|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.6484|TWO_SIDED|95.0|-5.07|3.19|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||3.19|-5.07|0.6484
73973397|NCT02510235|147489599|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7408|TWO_SIDED|95.0|-0.71|0.51|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.51|-0.71|0.7408
73973398|NCT02510235|147489600|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.8596|TWO_SIDED|95.0|-0.78|0.87|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.87|-0.78|0.8596
73973399|NCT02510235|147489601|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.7891|TWO_SIDED|95.0|-0.16|0.2|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Meibomian glands in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.20|-0.16|0.7891
73973400|NCT02510235|147489601|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6075|TWO_SIDED|95.0|-0.24|0.14|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Erythema in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.14|-0.24|0.6075
73973401|NCT02510235|147489601|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.6639|TWO_SIDED|95.0|-0.14|0.21|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.21|-0.14|0.6639
73973402|NCT02510235|147489601|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.3482|TWO_SIDED|95.0|-0.1|0.29|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Conjunctiva - Erythema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value is not duplicated or triplicated, reflecting the global outcome consistent with repeated measures ANOVA methodology.||0.29|-0.10|0.3482
73973403|NCT02510235|147489601|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.2422|TWO_SIDED|95.0|-0.34|0.09|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Conjunctiva - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.09|-0.34|0.2422
73973404|NCT02510235|147489601|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.8645|TWO_SIDED|95.0|-0.11|0.14|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Lens in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.14|-0.11|0.8645
73973405|NCT02510235|147489601|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.379|TWO_SIDED|95.0|-0.11|0.04|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Cornea transparency in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.04|-0.11|0.3790
74088947|NCT00486018|147731148|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-134.8|||<|0.0001||95.0|-172.7|-96.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-96.8|-172.7|<0.0001
73973406|NCT02510235|147489602|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8363|TWO_SIDED|95.0|-0.26|0.21|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.21|-0.26|0.8363
73973407|NCT02510235|147489603|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.6248|TWO_SIDED|95.0|-0.62|1.02|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||1.02|-0.62|0.6248
73973408|NCT02510235|147489604|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.6153|TWO_SIDED|95.0|-0.82|0.49|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.49|-0.82|0.6153
73973409|NCT00450216|147489605|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8|||<|0.0001|TWO_SIDED|95.0|4.4|15.3||CMH test stratified by use of low-dose aspirin (yes/no) and prior upper gastrointestinal (UGI) ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The primary efficacy endpoint was the number of participants developing gastric ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 24 weeks. The cumulative number of participants developing gastric ulcers at 24 weeks was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by use of low-dose aspirin and prior UGI ulcer history.||15.3|4.4|<0.0001
73973410|NCT00450216|147489606|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.8|||<|0.0001|TWO_SIDED|95.0|6.1|17.6||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing UGI (i.e., gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative number of participants developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history.||17.6|6.1|<0.0001
73973411|NCT00450216|147489607|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.8||||0.0006|TWO_SIDED|95.0|1.0|6.8||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing duodenal ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative number of participants developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prio UGI ulcer history at randomization.||6.8|1.0|0.0006
73973412|NCT05247034|147489632|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
73973413|NCT05247034|147489632|OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
73973414|NCT05247034|147489632|OTHER|||||||0.0125|||||||Wilcoxon (Mann-Whitney)|||||||0.0125
73973415|NCT05247034|147489633|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||For 1 Hz||||>0.05
73973416|NCT05247034|147489633|OTHER||||||>|0.05|||||||t-test, 2 sided|||5 and 10 Hz||||>0.05
73973417|NCT05247034|147489633|OTHER||||||>|0.05|||||||t-test, 2 sided|||For 1, 5 and 10 Hz||||>0.05
73973418|NCT05247034|147489633|OTHER||||||>|0.05|||||||t-test, 2 sided|||For 1, 5 and 10 Hz||||>0.05
74088948|NCT00486018|147731149|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.1||||0.0214||95.0|0.6|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||7.6|0.6|0.0214
74088949|NCT00486018|147731149|SUPERIORITY_OR_OTHER||Difference in Least Squares means|6.4||||0.0002||95.0|3.0|9.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||9.8|3.0|0.0002
73973419|NCT05247034|147489634|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
73973420|NCT05247034|147489634|OTHER|||||||0.042|||||||Friedman|||||||0.042
73973421|NCT05247034|147489634|OTHER|||||||0.015|||||||Friedman|||||||0.015
73973422|NCT05247034|147489635|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
73973423|NCT05247034|147489635|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
73973424|NCT05247034|147489635|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
73973425|NCT05247034|147489636|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
73973426|NCT05247034|147489636|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73973427|NCT05247034|147489636|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73973428|NCT05247034|147489637|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
73973429|NCT05247034|147489637|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73973430|NCT05247034|147489637|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74088950|NCT00486018|147731150|SUPERIORITY_OR_OTHER||Difference in Least Squares means|3.8||||0.0248||95.0|0.5|7.0|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||7.0|0.5|0.0248
73938006|NCT01581281|147407672|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1557|TWO_SIDED|95.0|0.85|5.05|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||5.05|0.85|0.1557
73938007|NCT01581281|147407672|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0754|TWO_SIDED|95.0|0.95|5.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||5.62|0.95|0.0754
73938008|NCT01581281|147407672|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7611|TWO_SIDED|95.0|0.49|1.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||1.62|0.49|0.7611
73938009|NCT01581281|147407673|SUPERIORITY|||||||0.3038|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||0.3038
73938010|NCT01581281|147407673|SUPERIORITY|||||||1|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||1.000
73938011|NCT01581281|147407673|SUPERIORITY|||||||0.2139|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||0.2139
73938012|NCT01392560|147407676|SUPERIORITY_OR_OTHER||Mean change from baseline|-19.6|STANDARD_ERROR_OF_MEAN|5.6||0.0011|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for all patients||||0.0011
73938013|NCT01392560|147407676|SUPERIORITY_OR_OTHER||Mean change from baseline|-30.8|STANDARD_ERROR_OF_MEAN|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test the difference between baseline and end of treatment under hyperglycaemia condition for all patients||||<0.0001
73938014|NCT01392560|147407676|SUPERIORITY_OR_OTHER||Change from baseline|-33.4|STANDARD_ERROR_OF_MEAN|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for hyperfilterers||||<0.0001
73938015|NCT01392560|147407676|SUPERIORITY_OR_OTHER||Mean change from baseline|-44.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for hyperfilterers||||<0.0001
73938016|NCT01392560|147407676|SUPERIORITY_OR_OTHER||Mean change from baseline|9.0|STANDARD_ERROR_OF_MEAN|5.9||0.1524|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for non-hyperfilterers||||0.1524
73938017|NCT01392560|147407676|SUPERIORITY_OR_OTHER||Mean change from baseline|-2.4|STANDARD_ERROR_OF_MEAN|7.7||0.7585|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for non-filterers||||0.7585
73938018|NCT02558010|147407693|SUPERIORITY||||||<|0.05||||||The p-value was calculated, and does not indicate the threshold for statistical significance.|Mixed Models Analysis|||||||<0.05
73938019|NCT00295750|147407694|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|1.9||||||97.5|-1.8|5.7||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.||5.7|-1.8|
73938020|NCT00295750|147407694|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|0.9||||||97.5|-3.2|5.0||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.||5.0|-3.2|
73938021|NCT00295750|147407695|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73938022|NCT00295750|147407695|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73938023|NCT00295750|147407696|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73938024|NCT00295750|147407696|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73938025|NCT00295750|147407698|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14||||<0.0001
73938026|NCT00295750|147407698|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14||||<0.0001
73938027|NCT00295750|147407698|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28||||<0.0001
73938028|NCT00295750|147407698|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28||||<0.0001
73973431|NCT05247034|147489638|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
73938029|NCT00295750|147407699|SUPERIORITY_OR_OTHER||Cumulative probability|85.8||||||95.0|79.8|90.1|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||90.1|79.8|
73938030|NCT00295750|147407699|SUPERIORITY_OR_OTHER||Cumulative probability|91.1||||||95.0|85.9|94.5|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||94.5|85.9|
73938031|NCT00295750|147407699|SUPERIORITY_OR_OTHER||Cumulative probability|85.9||||||95.0|79.9|90.2|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||90.2|79.9|
73938032|NCT04370054|147407719|NON_INFERIORITY|A repeated measures negative binomial regression model was used to test non-inferiority with non-inferiority margin = 3 bleeds/year at the one-sided alpha level = 0.025.|Mean Difference (Final Values)|-3.49|||=|0.004|TWO_SIDED|95.0|-6.06|-0.91||One-sided p-value is reported.|Generalized linear model (GLM)||Difference in mean = Mean PF-07055480 Total ABR - Mean FVIII Prophylaxis Total ABR.|A repeated measures GLM was used with bleeds as dependent variable in negative binomial distribution, an interaction of duration by treatment, and 'participant' as random and treatment \& duration of follow-up as fixed effect.||-0.91|-6.06|=0.0040
73938033|NCT04370054|147407720|SUPERIORITY||||||=|0.0086||||||One-sided p-value is reported.|One-sided exact binomial proportion test|||||||=0.0086
73938034|NCT04370054|147407721|NON_INFERIORITY|A repeated measures negative binomial regression model was used to test non-inferiority with non-inferiority margin = 3 bleeds/year at the one-sided alpha level = 0.025.|Mean Difference (Final Values)|-4.01|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.45||One-sided p-value is reported.|Repeated measures GLM||Difference in mean = Mean PF-07055480 Total ABR - Mean FVIII Prophylaxis Total ABR.|A repeated measures GLM was used with bleeds as dependent variable in negative binomial distribution, an interaction of duration by treatment, and 'participant' as random and treatment \& duration of follow-up as fixed effect.||-2.45|-5.57|<0.0001
73938035|NCT04370054|147407722|SUPERIORITY||Mean Difference (Final Values)|-124.18|||<|0.0001|TWO_SIDED|95.0|-139.47|108.89||One-sided p-value is reported.|Paired t-test||Treatment Difference = (PF-07055480 AIR - FVIII Prophylaxis AIR).|||108.89|-139.47|<0.0001
73938036|NCT04370054|147407724|SUPERIORITY||Mean Difference (Final Values)|-4076.06|||<|0.0001|TWO_SIDED|95.0|-4728.3|-3423.8||One-sided p-value is reported.|Paired t-test||Treatment Difference (FVIII Consumption post-IP Infusion - FVIII Consumption during FVIII Prophylaxis).|||-3423.8|-4728.3|<0.0001
73938037|NCT04953390|147407868|OTHER|||||||0.004|||||||ANOVA|||||||0.004
73938038|NCT04953390|147407869|OTHER|||||||0.029|||||||ANOVA|||||||.029
73938039|NCT04953390|147407870|OTHER|||||||0.0002|||||||ANOVA|||||||0.0002
73938040|NCT04953390|147407871|OTHER|||||||0.14|||||||t-test, 2 sided|T-test done on DIR2 and DIR3 results only, as the conditions were equal for these two settings. DIR1 was tested in a different condition.||All three DIR settings were tested, but only the DIR2 and DIR3 were compared in t-test. This is because DIR1 mic setting was tested in a different condition (i.e. softer noise).||||.14
73938041|NCT04953390|147407874|OTHER|||||||0.0003|||||||ANOVA|||||||.0003
73938042|NCT02008890|147407875|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5722|TWO_SIDED|95.0|0.5|3.53|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||3.53|0.50|0.5722
73938043|NCT02008890|147407875|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0411|TWO_SIDED|95.0|1.04|6.6|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||6.60|1.04|0.0411
73938044|NCT02008890|147407876|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.9431|TWO_SIDED|95.0|-4.59|3.47|||Regression, Linear|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||3.47|-4.59|0.9431
73938045|NCT02008890|147407876|SUPERIORITY||Mean Difference (Final Values)|-3.13||||0.1576|TWO_SIDED|95.0|-7.14|0.88|||Regression, Linear|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||0.88|-7.14|0.1576
73938046|NCT02207816|147407883|SUPERIORITY||Vaccine efficacy|74.38||||0.2235|TWO_SIDED|95.0|-130.0|97.14|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||97.14|-130|0.2235
73938047|NCT02207816|147407883|SUPERIORITY||Vaccine efficacy|-9.57||||0.8972|TWO_SIDED|95.0|-339.0|72.64|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||72.64|-339|0.8972
73938048|NCT02207816|147407883|SUPERIORITY||Vaccine efficacy|30.58||||0.5333|TWO_SIDED|95.0|-119.0|78.0|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||78.00|-119|0.5333
73938049|NCT02207816|147407883|SUPERIORITY||Vaccine efficacy|44.2||||0.3523|TWO_SIDED|95.0|-90.9|83.69|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||83.69|-90.9|0.3523
73938050|NCT02207816|147407884|SUPERIORITY||Vaccine efficacy|53.68||||0.093|TWO_SIDED|95.0|-13.7|81.13|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||81.13|-13.7|0.0930
73973432|NCT05247034|147489638|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73973433|NCT05247034|147489638|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73973434|NCT05247034|147489639|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
73866707|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|||||TWO_SIDED|95.0|0.06|0.91||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.91|0.06|
73866708|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.24|0.6||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.60|-0.24|
73866709|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.46|0.38||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.38|-0.46|
73866710|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.48|0.37||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.37|-0.48|
73866711|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|||||TWO_SIDED|95.0|0.15|1.06||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.06|0.15|
73938051|NCT02207816|147407884|SUPERIORITY||Vaccine efficacy|23.33||||0.5035|TWO_SIDED|95.0|-67.1|64.82|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||64.82|-67.1|0.5035
73938052|NCT02207816|147407884|SUPERIORITY||Vaccine efficacy|32.08||||0.3504|TWO_SIDED|95.0|-53.1|69.87|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||69.87|-53.1|0.3504
73938053|NCT02207816|147407884|SUPERIORITY||Vaccine efficacy|37.57||||0.2704|TWO_SIDED|95.0|-44.4|73.01|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||73.01|-44.4|0.2704
73938054|NCT02207816|147407885|SUPERIORITY||Vaccine efficacy|-5.26||||0.4434|TWO_SIDED|95.0|-20.0|7.69|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||7.69|-20.0|0.4434
73938055|NCT02207816|147407885|SUPERIORITY||Vaccine efficacy|-8.1||||0.2634|TWO_SIDED|95.0|-23.9|5.7|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||5.70|-23.9|0.2634
73938056|NCT02207816|147407885|SUPERIORITY||Vaccine efficacy|0.62||||0.9278|TWO_SIDED|95.0|-13.7|13.13|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||13.13|-13.7|0.9278
73938057|NCT02207816|147407885|SUPERIORITY||Vaccine efficacy|5.32||||0.4189|TWO_SIDED|95.0|-8.12|17.09|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||17.09|-8.12|0.4189
73938058|NCT02207816|147407886|SUPERIORITY||Vaccine efficacy|50.1||||0.1302|TWO_SIDED|95.0|-32.2|82.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||82.90|-32.2|0.1302
73938059|NCT02207816|147407886|SUPERIORITY||Vaccine efficacy|16.9||||0.6897|TWO_SIDED|95.0|-96.9|65.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||65.90|-96.9|0.6897
73938060|NCT02207816|147407886|SUPERIORITY||Vaccine efficacy|25.9||||0.5299|TWO_SIDED|95.0|-82.9|70.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||70.90|-82.9|0.5299
73973435|NCT05247034|147489639|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73973436|NCT05247034|147489639|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73973437|NCT05247034|147489640|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
73973438|NCT05247034|147489640|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73938061|NCT02207816|147407886|SUPERIORITY||Vaccine efficacy|25.4||||0.5307|TWO_SIDED|95.0|-84.1|70.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||70.70|-84.1|0.5307
73973439|NCT05247034|147489640|OTHER||||||>|0.05|||||||Friedman|||||||>0.05
73973440|NCT05247034|147489641|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
73938062|NCT02207816|147407887|SUPERIORITY||Vaccine efficacy|46.2||||0.1853|TWO_SIDED|95.0|-45.0|81.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||81.80|-45.0|0.1853
73938063|NCT02207816|147407887|SUPERIORITY||Vaccine efficacy|35.0||||0.3828|TWO_SIDED|95.0|-69.3|76.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||76.60|-69.3|0.3828
73938064|NCT02207816|147407887|SUPERIORITY||Vaccine efficacy|31.2||||0.4112|TWO_SIDED|95.0|-66.5|72.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||72.70|-66.5|0.4112
73938065|NCT02207816|147407887|SUPERIORITY||Vaccine efficacy|30.8||||0.4121|TWO_SIDED|95.0|-67.6|72.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||72.50|-67.6|0.4121
73938066|NCT02207816|147407888|SUPERIORITY||Vaccine efficacy|40.8|||<|0.0001|TWO_SIDED|95.0|15.7|58.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||58.80|15.70|<0.0001
73938067|NCT02207816|147407888|SUPERIORITY||Vaccine effiicacy|42.7|||<|0.0001|TWO_SIDED|95.0|17.4|60.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||60.80|17.40|<0.0001
73938068|NCT02207816|147407888|SUPERIORITY||Vaccine efficacy|16.0||||0.0883|TWO_SIDED|95.0|-6.6|33.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||33.90|-6.60|0.0883
73973441|NCT05247034|147489641|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73973442|NCT05247034|147489641|OTHER||||||>|0.05|||||||Friedman|||||||>0.05
73973443|NCT05247034|147489642|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
73973444|NCT05247034|147489642|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73973445|NCT05247034|147489642|OTHER|||||||0.0027|||||||Wilcoxon (Mann-Whitney)|||||||0.0027
73973446|NCT05247034|147489643|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
73973447|NCT05247034|147489643|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73938069|NCT02207816|147407888|SUPERIORITY||Vaccine efficacy|13.0||||0.1889|TWO_SIDED|95.0|-10.7|31.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||31.70|-10.7|0.1889
73973448|NCT05247034|147489643|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.0430
73973449|NCT05247034|147489644|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
73973450|NCT05247034|147489644|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73938070|NCT02207816|147407888|SUPERIORITY||Vaccine efficacy|16.4||||0.077|TWO_SIDED|95.0|-5.9|34.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||34.00|-5.90|0.0770
73973451|NCT05247034|147489644|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73973452|NCT05247034|147489645|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
73973453|NCT05247034|147489645|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73973454|NCT05247034|147489645|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73973455|NCT05247034|147489646|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
73973456|NCT05247034|147489646|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73973457|NCT05247034|147489646|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73973458|NCT05247034|147489647|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
73973459|NCT05247034|147489647|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73973460|NCT05247034|147489647|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73973461|NCT05247034|147489648|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
73973462|NCT05247034|147489648|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73973463|NCT05247034|147489648|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73973464|NCT05247034|147489649|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
73973465|NCT05247034|147489649|OTHER|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||||||0.0007
73973466|NCT05247034|147489649|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73973467|NCT03334695|147489712|SUPERIORITY|||||||0.012|||||||Wilcoxon Rank Sum test|||||||0.012
73866712|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.28|0.63||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.63|-0.28|
73866713|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.49|0.42||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.49|
73866714|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.47|0.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.47|
73866715|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|0.22|1.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.18|0.22|
73866716|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.18|0.78||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.78|-0.18|
73866717|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.55|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.55|
73938071|NCT02207816|147407888|SUPERIORITY||Vaccine efficacy|0.1||||1|TWO_SIDED|95.0|-25.8|20.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||20.70|-25.8|1.0000
73938072|NCT02207816|147407888|SUPERIORITY||Vaccine efficacy|20.8||||0.1624|TWO_SIDED|95.0|-17.5|46.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||46.90|-17.5|0.1624
73938073|NCT02207816|147407888|SUPERIORITY||Vaccine efficacy|-2.3||||0.9112|TWO_SIDED|95.0|-47.6|29.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||29.00|-47.6|0.9112
73938074|NCT02207816|147407888|SUPERIORITY||Vaccine efficacy|9.2||||0.4023|TWO_SIDED|95.0|-18.0|30.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||30.10|-18.0|0.4023
73938075|NCT02207816|147407888|SUPERIORITY||Vaccine efficacy|-4.4||||0.7091|TWO_SIDED|95.0|-34.5|18.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||18.90|-34.5|0.7091
73938076|NCT02207816|147407888|SUPERIORITY||Vaccine efficacy|-1.4||||0.9361|TWO_SIDED|95.0|-34.7|23.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||23.60|-34.7|0.9361
74088951|NCT00486018|147731150|SUPERIORITY_OR_OTHER||Difference in Least Squares means|5.1||||0.0014||95.0|2.0|8.3|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||8.3|2.0|0.0014
73866718|NCT01393639|147278699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.47|0.49||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.49|-0.47|
73938077|NCT02207816|147407888|SUPERIORITY||Vaccine efficacy|-6.8||||0.628|TWO_SIDED|95.0|-42.0|19.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||19.60|-42.0|0.6280
73866719|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.76|0.03||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.03|-0.76|
73938078|NCT02207816|147407889|SUPERIORITY||Vaccine efficacy|100.0||||0.4987|TWO_SIDED|95.0|-3779.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||100.0|-3779|0.4987
73938079|NCT02207816|147407889|SUPERIORITY||Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-4051.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||100.0|-4051|1.0000
74088952|NCT03291041|147731151|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|34.75||||0.0354|TWO_SIDED||||||ANCOVA|||||||0.0354
73866720|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||||TWO_SIDED|95.0|-1.17|-0.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.39|-1.17|
73866721|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|||||TWO_SIDED|95.0|-1.32|-0.54||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.32|
73866722|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.17|||||TWO_SIDED|95.0|-1.56|-0.78||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.78|-1.56|
73938080|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|-254.6||||0.1025|TWO_SIDED|95.0|-3399.0|32.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||32.50|-3399|0.1025
73938081|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|-398.6||||0.0284|TWO_SIDED|95.0|-4642.0|-3.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||-3.20|-4642|0.0284
73938082|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|36.7||||0.3543|TWO_SIDED|95.0|-78.8|79.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||79.20|-78.8|0.3543
73973468|NCT02641730|147489726|SUPERIORITY||Mean Difference (Final Values)|-7.69|STANDARD_ERROR_OF_MEAN|1.674|<|0.001|TWO_SIDED|95.0|-11.0|-4.383|||Mixed-Model for Repeated Measures|||||-4.383|-11.000|<0.001
73973469|NCT02641730|147489726|SUPERIORITY||Mean Difference (Final Values)|-4.11|STANDARD_ERROR_OF_MEAN|1.7||0.017|TWO_SIDED|95.0|-7.468|-0.748|||Mixed-Model for Repeated Measures|||||-0.748|-7.468|0.017
74030732|NCT01809262|147615436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.253|0.447|||ANCOVA|||||0.447|0.253|<0.0001
74030733|NCT01809262|147615436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.455|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.359|0.551|||ANCOVA|||||0.551|0.359|<0.0001
74030734|NCT02064439|147615444|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.0001|TWO_SIDED|95.0|0.2|0.59||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.59|0.20|0.0001
74030735|NCT02064439|147615444|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|98.0|0.14|0.47||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.47|0.14|<0.0001
73938083|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|3.2||||1|TWO_SIDED|95.0|-151.0|63.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||63.20|-151|1.0000
73938084|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|44.0||||0.3809|TWO_SIDED|95.0|-120.0|88.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||88.00|-120|0.3809
73973470|NCT03969563|147489762|EQUIVALENCE|Equivalence based on non-significant difference between MBSR and Brain Health groups.|Mean Difference (Final Values)|0.3||||0.694|TWO_SIDED||||||Mixed Models Analysis|||||||.694
73973471|NCT03969563|147489763|EQUIVALENCE|Equivalence based on non-significant difference between MBSR vs Brain Health group.|Mean Difference (Final Values)|-1.4||||0.837|TWO_SIDED||||||Mixed Models Analysis|||||||.837
73973472|NCT02326974|147489770|SUPERIORITY||||||<|0.001|||||||Mantel Haenszel|||By estimating that the overall pCR with T-DM1 plus pertuzumab would be approximately 40%, and 20% of the population classified as heterogeneous, the study would have 80% power with 136 evaluable patients to detect a difference in pCR of 44.9% in the non-heterogenous versus 20.3% in the heterogenous subgroup. The study had a 90% power to detect difference in pCR of 43.4% in the non-heterogenous versus 8.8% in the heterogenous subgroup if the observed prevalence of HER2 heterogeneity was 10%.||||<0.001
74030736|NCT02064439|147615444|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.4328|TWO_SIDED|95.0|0.65|2.75||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||2.75|0.65|0.4328
74088953|NCT03291041|147731152|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-0.63||||0.0168|TWO_SIDED||||||ANCOVA|||||||0.0168
74088954|NCT03291041|147731153|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|90.56||||0.0785|TWO_SIDED||||||ANCOVA|||||||0.0785
74088955|NCT03291041|147731154|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|78.45||||0.0225|TWO_SIDED||||||ANCOVA|||||||0.0225
74088956|NCT03291041|147731155|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|0.95||||0.0198|TWO_SIDED||||||ANCOVA|||||||0.0198
73938085|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|39.1||||0.549|TWO_SIDED|95.0|-140.0|86.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||86.90|-140|0.5490
73938086|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|-46.3||||0.3239|TWO_SIDED|95.0|-249.0|36.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||36.20|-249|0.3239
73938087|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|47.6||||0.2184|TWO_SIDED|95.0|-54.5|84.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||84.10|-54.5|0.2184
73938088|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|-116.8||||0.0724|TWO_SIDED|95.0|-476.0|10.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||10.30|-476|0.0724
73938089|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|-81.0||||0.2055|TWO_SIDED|95.0|-393.0|27.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||27.90|-393|0.2055
73938090|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|-18.4||||0.8138|TWO_SIDED|95.0|-245.0|57.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||57.90|-245|0.8138
73938091|NCT02207816|147407890|SUPERIORITY||Vaccine efficacy|24.4||||0.7887|TWO_SIDED|95.0|-148.0|78.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||78.40|-148|0.7887
73938092|NCT02207816|147407891|SUPERIORITY||Vaccine efficacy|40.5||||0.0077|TWO_SIDED|95.0|12.84|59.39|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||59.39|12.84|0.0077
73938093|NCT02207816|147407891|SUPERIORITY||Vaccine efficacy|-4.52||||0.7922|TWO_SIDED|95.0|-45.3|24.8|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||24.80|-45.3|0.7922
73938094|NCT02207816|147407891|SUPERIORITY||Vaccine efficacy|29.03||||0.0802|TWO_SIDED|95.0|-4.22|51.67|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||51.67|-4.22|0.0802
73938095|NCT02207816|147407891|SUPERIORITY||Vaccine efficacy|33.87||||0.0387|TWO_SIDED|95.0|2.13|55.32|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||55.32|2.13|0.0387
73938096|NCT02207816|147407892|SUPERIORITY||Vaccine efficacy|36.69||||0.0028|TWO_SIDED|95.0|14.6|53.07|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||53.07|14.60|0.0028
73938097|NCT02207816|147407892|SUPERIORITY||Vaccine efficacy|10.14||||0.443|TWO_SIDED|95.0|-18.1|31.64|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||31.64|-18.1|0.4430
73938098|NCT02207816|147407892|SUPERIORITY||Vaccine efficacy|30.99||||0.0245|TWO_SIDED|95.0|4.67|50.04|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||50.04|4.67|0.0245
73938099|NCT02207816|147407892|SUPERIORITY||Vaccine efficacy|34.24||||0.0122|TWO_SIDED|95.0|8.74|52.61|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||52.61|8.74|0.0122
73973473|NCT04173247|147489783|OTHER|A t-test with 180 degrees of freedom to compare the mean DLQI score over the 6 weeks in arm1 to the mean DLQI score over six weeks in arm2.||||||0.28|||||||t-test, 1 sided|||||||0.28
73973474|NCT04424316|147489812|OTHER||Vaccine Efficacy|57.6|||||TWO_SIDED|95.0|31.3|74.6||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||74.6|31.3|
73938100|NCT02207816|147407893|SUPERIORITY||Vaccine efficacy|23.67|||<|0.0001|TWO_SIDED|95.0|15.93|30.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||30.71|15.93|<.0001
73938101|NCT02207816|147407893|SUPERIORITY||Vaccine efficacy|19.15|||<|0.0001|TWO_SIDED|95.0|10.81|26.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||26.71|10.81|<.0001
73938102|NCT02207816|147407893|SUPERIORITY||Vaccine efficacy|15.55||||0.0009|TWO_SIDED|95.0|6.72|23.54|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||23.54|6.72|0.0009
73938103|NCT02207816|147407893|SUPERIORITY||Vaccine efficacy|13.15||||0.0056|TWO_SIDED|95.0|4.05|21.39|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||21.39|4.05|0.0056
73938104|NCT02207816|147407894|SUPERIORITY||Vaccine efficacy|35.5||||0.0053|TWO_SIDED|95.0|10.0|54.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||54.00|10.00|0.0053
73938105|NCT02207816|147407894|SUPERIORITY||Vaccine efficacy|11.7||||0.4255|TWO_SIDED|95.0|-20.0|35.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||35.20|-20.0|0.4255
73938106|NCT02207816|147407894|SUPERIORITY||Vaccine efficacy|29.2||||0.0479|TWO_SIDED|95.0|-2.4|51.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||51.40|-2.40|0.0479
73938107|NCT02207816|147407894|SUPERIORITY||Vaccine efficacy|18.1||||0.2346|TWO_SIDED|95.0|-16.9|42.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||42.80|-16.9|0.2346
73938108|NCT02207816|147407895|SUPERIORITY||Vaccine efficacy|35.9||||0.0051|TWO_SIDED|95.0|10.3|54.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||54.40|10.30|0.0051
73957858|NCT02715258|147451253|SUPERIORITY||mixed-effects repeated measures|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.36||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 18||-0.36|-0.78|<0.0001
73957859|NCT02715258|147451253|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0012|TWO_SIDED|95.0|-0.66|-0.16||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 24||-0.16|-0.66|0.0012
73957860|NCT02715258|147451253|SUPERIORITY||mixed-effects repeated measures|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.39||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) across 24 weeks||-0.39|-0.76|<0.0001
73957861|NCT02715258|147451254|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0006|TWO_SIDED|95.0|1.69|6.8||The logistic regression includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Model-Adjusted proportion of subjects with HbA1c \<7% across 24 weeks||6.80|1.69|0.0006
73957862|NCT02814643|147451255|OTHER||Geometric least-square mean ratio|0.87|||||TWO_SIDED|90.0|0.56|1.35|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H1N1||1.35|0.56|
73957863|NCT02814643|147451255|OTHER||Geometric least-square mean ratio|1.19|||||TWO_SIDED|90.0|0.82|1.71|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H3N2||1.71|0.82|
73957864|NCT02814643|147451255|OTHER||Geometric least-square mean ratio|0.93|||||TWO_SIDED|90.0|0.67|1.29|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Yamagata lineage||1.29|0.67|
73957865|NCT02814643|147451255|OTHER||Geometric least-square mean ratio|0.8|||||TWO_SIDED|90.0|0.54|1.19|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Victoria lineage||1.19|0.54|
73938109|NCT02207816|147407895|SUPERIORITY||Vaccine efficacy|14.0||||0.334|TWO_SIDED|95.0|-17.3|37.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||37.10|-17.3|0.3340
73938110|NCT02207816|147407895|SUPERIORITY||Vaccine efficacy|28.5||||0.0511|TWO_SIDED|95.0|-2.9|50.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||50.50|-2.90|0.0511
73938111|NCT02207816|147407895|SUPERIORITY||Vaccine efficacy|20.3||||0.1729|TWO_SIDED|95.0|-13.5|44.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||44.20|-13.5|0.1729
73938112|NCT02207816|147407898|SUPERIORITY||Vaccine efficacy|50.1||||0.6244|TWO_SIDED|95.0|-859.0|99.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||99.20|-859|0.6244
73938113|NCT02207816|147407898|SUPERIORITY||Vaccine efficacy|-5.7||||1|TWO_SIDED|95.0|-1358.0|92.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||92.30|-1358|1.0000
73938114|NCT02207816|147407898|SUPERIORITY||Vaccine efficacy|-188.9||||0.6244|TWO_SIDED|95.0|-15000.0|76.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||76.80|-15000|0.6244
73938115|NCT02207816|147407898|SUPERIORITY||Vaccine efficacy|3.1||||1|TWO_SIDED|95.0|-7509.0|98.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||98.80|-7509|1.0000
73938116|NCT02207816|147407899|SUPERIORITY||Vaccine efficacy|-98.8||||0.6869|TWO_SIDED|95.0|-2098.0|71.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||71.50|-2098|0.6869
73938117|NCT02207816|147407899|SUPERIORITY||Vaccine efficacy|-406.0||||0.0213|TWO_SIDED|95.0|-4650.0|-7.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||-7.80|-4650|0.0213
73938118|NCT02207816|147407900|SUPERIORITY||Vaccine efficacy|-98.8||||1|TWO_SIDED|95.0|-12000.0|89.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||89.60|-12000|1.0000
73938119|NCT02207816|147407900|SUPERIORITY||Vaccine efficacy|-304.8||||0.2154|TWO_SIDED|95.0|-20000.0|59.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||59.90|-20000|0.2154
73938120|NCT02207816|147407901|SUPERIORITY||Vaccine efficacy|-24.3||||1|TWO_SIDED|95.0|-526.0|73.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||73.30|-526|1.0000
73938121|NCT02207816|147407901|SUPERIORITY||Vaccine efficacy|-77.1||||0.3834|TWO_SIDED|95.0|-725.0|55.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||55.00|-725|0.3834
73938122|NCT02207816|147407901|SUPERIORITY||Vaccine efficacy|-297.5||||0.374|TWO_SIDED|95.0|-19000.0|60.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||60.70|-19000|0.3740
74030737|NCT02064439|147615445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01||||0.3235|TWO_SIDED|95.0|0.5|8.04||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||8.04|0.50|0.3235
74030738|NCT02064439|147615445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.5005|TWO_SIDED|95.0|0.39|6.84||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||6.84|0.39|0.5005
73938123|NCT02207816|147407901|SUPERIORITY||Vaccine efficacy|-498.1||||0.124|TWO_SIDED|95.0|-27000.0|27.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||27.40|-27000|0.1240
73938124|NCT00765843|147407908|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||baseline comparisons||||0.78
73938125|NCT00765843|147407908|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANOVA|||one month comparisons||||0.21
74088957|NCT03291041|147731156|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-26.55||||0.0347|TWO_SIDED||||||ANCOVA|||||||0.0347
73938126|NCT00765843|147407908|SUPERIORITY_OR_OTHER|||||||0.93|||||||ANOVA|||three months comparisons||||0.93
73938127|NCT01571362|147408068|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.246||0.0114|TWO_SIDED|95.0|-1.11|-0.14||No adjustment was made for multiple comparisons. Statistical significance was if unadjusted p was less than or equal to (\<=) 0.05.|ANCOVA|||Null Hypothesis: No treatment difference. Power was 90%, 2-sided Alpha of 0.05, with assumed difference of 1 point and assumed standard deviation of 2.4 points.||-0.14|-1.11|0.0114
73938128|NCT01571362|147408069|SUPERIORITY_OR_OTHER||Difference of LS Means|0.18|STANDARD_ERROR_OF_MEAN|0.565||0.7547|TWO_SIDED|95.0|-0.94|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and Baseline score and final total daily dose of Titration Period as covariates.|ANCOVA|||||1.29|-0.94|0.7547
73938129|NCT01571362|147408070|SUPERIORITY_OR_OTHER|||||||0.1272|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) stratified by prior pain analgesic (opioid or non-opioid)||||||0.1272
73938130|NCT01571362|147408071|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|CMH was stratified by prior pain analgesic (opioid and non-opioid).||||||0.0210
73938131|NCT01571362|147408072|SUPERIORITY_OR_OTHER|||||||0.0248|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0248
74088958|NCT03291041|147731157|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-56.44||||0.084|TWO_SIDED||||||ANCOVA|||||||0.0840
74088959|NCT03291041|147731158|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0765|TWO_SIDED||||||ANCOVA|||||||0.0765
74088960|NCT02985879|147731160|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.34|=|0.998|TWO_SIDED|95.0|-2.63|2.63|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||2.63|-2.63|=0.998
73938132|NCT01571362|147408073|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0090
73938133|NCT01571362|147408074|SUPERIORITY_OR_OTHER|||||||0.0874|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0874
73938134|NCT01571362|147408075|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Worst Pain Score||||<0.0001
73938135|NCT01571362|147408075|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Least Pain Score||||<0.0001
74088961|NCT02985879|147731160|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.32|=|0.464|TWO_SIDED|95.0|-1.63|3.58|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||3.58|-1.63|=0.464
73938136|NCT01571362|147408075|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Average Pain Score||||<0.0001
73938137|NCT01571362|147408075|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Right Now||||<0.0001
73938138|NCT01571362|147408075|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Severity Index||||<0.0001
73938139|NCT01571362|147408075|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Interference Index||||<0.0001
73938140|NCT01571362|147408076|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Worst Pain Score||||<0.0001
73938141|NCT01571362|147408076|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Least Pain Score||||<0.0001
73938142|NCT01571362|147408076|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Average Pain Score||||<0.0001
73938143|NCT01571362|147408076|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Right Now||||<0.0001
73938144|NCT01571362|147408076|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Severity Index||||<0.0001
73938145|NCT01571362|147408076|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Interference Index||||<0.0001
73957866|NCT02814643|147451256|OTHER||Geometric least-square mean ratio|1.0|||||TWO_SIDED|90.0|0.76|1.31|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H1N1||1.31|0.76|
73866723|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.7|0.09||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.09|-0.70|
73938146|NCT01571362|147408077|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.222||0.0056|TWO_SIDED|95.0|-1.06|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.18|-1.06|0.0056
73938147|NCT01571362|147408077|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.243||0.009|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.16|-1.12|0.0090
73938148|NCT01571362|147408077|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.271||0.1684|TWO_SIDED|95.0|-0.91|0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||0.16|-0.91|0.1684
73938149|NCT01571362|147408077|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.50|-1.46|<0.0001
73938150|NCT01571362|147408078|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.193||0.0412|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2||-0.02|-0.78|0.0412
73938151|NCT01571362|147408078|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.87|STANDARD_ERROR_OF_MEAN|0.201|<|0.0001|TWO_SIDED|95.0|-1.27|-0.48|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4||-0.48|-1.27|<0.0001
73938152|NCT01571362|147408078|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.226||0.0055|TWO_SIDED|95.0|-1.08|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.19|-1.08|0.0055
73938153|NCT01571362|147408078|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.27|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.44|-1.27|<0.0001
74030739|NCT02064439|147615445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.7337|TWO_SIDED|95.0|0.37|4.03||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||4.03|0.37|0.7337
74030740|NCT02064439|147615446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.2|0.57||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.57|0.20|<0.0001
74030741|NCT02064439|147615446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.19|0.54||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.54|0.19|<0.0001
74030742|NCT02064439|147615446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.8172|TWO_SIDED|95.0|0.57|2.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||2.06|0.57|0.8172
74030743|NCT02064439|147615447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.3318|TWO_SIDED|95.0|0.69|3.02||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||3.02|0.69|0.3318
74030744|NCT02064439|147615447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9726|TWO_SIDED|95.0|0.44|2.2||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||2.20|0.44|0.9726
74030745|NCT02064439|147615447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.3137|TWO_SIDED|95.0|0.7|3.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||3.06|0.70|0.3137
74030746|NCT02433288|147615448|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Log Rank|||||||0.0019
74030747|NCT02433288|147615449|SUPERIORITY_OR_OTHER|||||||0.0017|||||||Chi-squared|||||||0.0017
73957867|NCT02814643|147451256|OTHER||Geometric least-square mean ratio|1.28|||||TWO_SIDED|90.0|0.93|1.77|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H3N2||1.77|0.93|
74030748|NCT02433288|147615450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.24|STANDARD_ERROR_OF_MEAN|3.39|<|0.0001|TWO_SIDED|95.0|-26.91|-13.57|||t-test, 2 sided|||||-13.57|-26.91|<0.0001
74030749|NCT02433288|147615451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.6||0.3939|TWO_SIDED|95.0|-4.56|1.8|||t-test, 2 sided|||||1.80|-4.56|0.3939
73938154|NCT01571362|147408079|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.19||0.0007|TWO_SIDED|95.0|-1.02|-0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.27|-1.02|0.0007
73938155|NCT01571362|147408079|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.74|STANDARD_ERROR_OF_MEAN|0.213||0.0006|TWO_SIDED|95.0|-1.16|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.32|-1.16|0.0006
73938156|NCT01571362|147408079|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.236||0.007|TWO_SIDED|95.0|-1.11|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.18|-1.11|0.0070
73938157|NCT01571362|147408079|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-1.31|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.44|-1.31|<0.0001
73938158|NCT01571362|147408080|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.207||0.0022|TWO_SIDED|95.0|-1.05|-0.23|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.23|-1.05|0.0022
73938159|NCT01571362|147408080|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.214||0.0003|TWO_SIDED|95.0|-1.21|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.37|-1.21|0.0003
73938160|NCT01571362|147408080|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.264||0.0078|TWO_SIDED|95.0|-1.23|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.19|-1.23|0.0078
73938161|NCT01571362|147408080|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.231|<|0.0001|TWO_SIDED|95.0|-1.52|-0.62|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.62|-1.52|<0.0001
73938162|NCT01571362|147408081|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.189||0.0022|TWO_SIDED|95.0|-0.95|-0.21|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.21|-0.95|0.0022
73938163|NCT01571362|147408081|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.198||0.0002|TWO_SIDED|95.0|-1.15|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.37|-1.15|0.0002
74030750|NCT02433288|147615452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|1.99||0.7514|TWO_SIDED|95.0|-3.27|4.53|||ANCOVA|linear model including terms for randomized group and baseline LDL-C||||4.53|-3.27|0.7514
74030751|NCT03350750|147615453|SUPERIORITY||ANCOVA Model Effect (Open vs. Closed)|0.22||||0.071|TWO_SIDED|95.0|-0.02|0.46|||ANCOVA||This is the coefficient for an indicator variable comparing the Open versus Closed shunt group, in a linear regression model with Month 4 gait velocity as the outcome and Baseline gait velocity included as a predictor along with treatment.|||0.46|-0.02|0.071
74030752|NCT03350750|147615454|SUPERIORITY|||||||0.337|||||||ANCOVA|||||||0.337
73866724|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-1.34|-0.55||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.55|-1.34|
74030753|NCT03350750|147615455|SUPERIORITY|||||||0.007|||||||ANCOVA|||||||0.007
73957868|NCT02814643|147451256|OTHER||Geometric least-square mean ratio|1.03||||||90.0|0.79|1.34|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Yamagata lineage||1.34|0.79|
73957869|NCT02814643|147451256|OTHER||Geometric least-square mean ratio|1.26||||||90.0|0.93|1.7|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Victoria lineage||1.70|0.93|
74030754|NCT03350750|147615456|SUPERIORITY|||||||0.201|||||||ANCOVA|||||||0.201
74030755|NCT03350750|147615457|SUPERIORITY|||||||0.172|||||||ANCOVA|||||||0.172
73957870|NCT02263508|147451265|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.13|TWO_SIDED|95.0|0.71|1.04|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.04|0.71|0.13
74030756|NCT03350750|147615458|SUPERIORITY|||||||0.78|||||||ANCOVA|||||||0.780
74030757|NCT03350750|147615459|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74030758|NCT03350750|147615460|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.240
73866725|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.84|0.07||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.07|-0.84|
73866726|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||||TWO_SIDED|95.0|-1.23|-0.32||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.32|-1.23|
73866727|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.06|||||TWO_SIDED|95.0|-1.52|-0.61||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.61|-1.52|
73938164|NCT01571362|147408081|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.61|STANDARD_ERROR_OF_MEAN|0.228||0.0078|TWO_SIDED|95.0|-1.06|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.16|-1.06|0.0078
73938165|NCT01571362|147408081|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.207|<|0.0001|TWO_SIDED|95.0|-1.35|-0.54|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.54|-1.35|<0.0001
73938166|NCT01571362|147408082|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.188||0.0285|TWO_SIDED|95.0|-0.78|-0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.04|-0.78|0.0285
73973475|NCT04424316|147489813|OTHER||Vaccine Efficacy|54.5|||||TWO_SIDED|95.0|33.2|69.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||69.5|33.2|
74030759|NCT03350750|147615461|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
73866728|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-1.45|-0.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.45|
74030760|NCT03350750|147615462|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
74030761|NCT03350750|147615463|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
74030762|NCT03350750|147615464|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
74030763|NCT03350750|147615465|SUPERIORITY|||||||0.235|||||||Fisher Exact|Fisher's exact test with a mid-p-value correction||||||0.235
74030764|NCT01849250|147615482|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||.50
74030765|NCT01849250|147615485|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||.19
73866729|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.71|0.21||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.21|-0.71|
73866730|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.02|||||TWO_SIDED|95.0|-1.48|-0.57||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.57|-1.48|
73973476|NCT04424316|147489814|OTHER||Vaccine Efficacy|50.0|||||TWO_SIDED|95.0|30.3|64.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||64.5|30.3|
73973477|NCT04424316|147489815|OTHER||Vaccine Efficacy|49.2|||||TWO_SIDED|95.0|31.4|62.8||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||62.8|31.4|
73973478|NCT04424316|147489816|OTHER||Vaccine Efficacy|82.4|||||TWO_SIDED|95.0|57.5|93.9||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||93.9|57.5|
73973479|NCT04424316|147489817|OTHER||Vaccine Efficacy|73.5|||||TWO_SIDED|95.0|50.3|86.8||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||86.8|50.3|
73973480|NCT04424316|147489818|OTHER||Vaccine Efficacy|70.5|||||TWO_SIDED|95.0|49.4|83.6||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||83.6|49.4|
73973481|NCT04424316|147489819|OTHER||Vaccine Efficacy|70.0|||||TWO_SIDED|95.0|50.6|82.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||82.5|50.6|
73973482|NCT04424316|147489835|OTHER||Vaccine efficacy|69.7|||||TWO_SIDED|95.0|37.1|86.7||||||Vaccine efficacy within 90 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||86.7|37.1|
73973483|NCT04424316|147489835|OTHER||Vaccine efficacy|61.5|||||TWO_SIDED|95.0|28.6|80.3||||||Vaccine efficacy within 120 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||80.3|28.6|
73973484|NCT04424316|147489835|OTHER||Vaccine efficacy|57.1|||||TWO_SIDED|95.0|23.9|76.8||||||Vaccine efficacy within 150 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||76.8|23.9|
73866731|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.89|0.11||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.11|-0.89|
73866732|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|95.0|-1.44|-0.45||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.45|-1.44|
73866733|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-1.71|-0.71||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.71|-1.71|
73866734|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|95.0|-1.59|-0.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-1.59|
73866735|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-0.95|0.05||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-0.95|
73866736|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-1.65|-0.66||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.66|-1.65|
73866737|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.96|0.08||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.08|-0.96|
73866738|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.48|-0.44||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.44|-1.48|
73866739|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.43|||||TWO_SIDED|95.0|-1.94|-0.91||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.91|-1.94|
73866740|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|95.0|-1.8|-0.76||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.76|-1.80|
73866741|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|||||TWO_SIDED|95.0|-1.06|-0.03||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-1.06|
73866742|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|||||TWO_SIDED|95.0|-1.85|-0.81||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.81|-1.85|
73866743|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.59|||||TWO_SIDED|95.0|0.19|0.98||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.98|0.19|
73866744|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.22|0.56||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-0.22|
73866745|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.38|0.41||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.41|-0.38|
73866746|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.62|0.16||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-0.62|
73866747|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64|||||TWO_SIDED|95.0|0.18|1.09||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.09|0.18|
74030766|NCT01849250|147615486|SUPERIORITY|||||||0.52|||||||ANOVA|||||||.52
74030767|NCT01849250|147615487|SUPERIORITY|||||||0.12|||||||ANCOVA|||||||.12
73866748|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.21|0.7||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.70|-0.21|
73866749|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.5|0.42||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.50|
73866750|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.43|0.48||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.48|-0.43|
73866751|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|0.26|1.26||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.26|0.26|
73866752|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|-0.29|0.7||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.70|-0.29|
73866753|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.55|0.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.55|
73866754|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.43|0.56||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-0.43|
73866755|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|||||TWO_SIDED|95.0|0.37|1.41||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.41|0.37|
73866756|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|95.0|-0.15|0.89||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.89|-0.15|
73866757|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-0.61|0.42||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.61|
73866758|NCT01393639|147278701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-0.46|0.57||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.57|-0.46|
73973485|NCT04424316|147489835|OTHER||Vaccine efficacy|55.3|||||TWO_SIDED|95.0|23.8|74.6||||||Vaccine efficacy within 180 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||74.6|23.8|
73973486|NCT04424316|147489835|OTHER||Vaccine efficacy|24.2|||||TWO_SIDED|95.0|-11.1|48.6||||||Vaccine efficacy within 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||48.6|-11.1|
74030768|NCT01600131|147615514|SUPERIORITY||Slope|-0.68|STANDARD_ERROR_OF_MEAN|1.72||0.693|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.693
74030769|NCT01600131|147615515|SUPERIORITY||Slope|-2.17|STANDARD_ERROR_OF_MEAN|2.07||0.693|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group x time interaction|||||0.693
74030770|NCT01600131|147615516|SUPERIORITY||Slope|-2.08|STANDARD_ERROR_OF_MEAN|1.08||0.055|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.055
73866759|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.38|||||TWO_SIDED|95.0|-4.94|2.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.17|-4.94|
73866760|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-3.98|3.08||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.08|-3.98|
73973487|NCT04424316|147489836|OTHER||Vaccine efficacy|9.5|||||TWO_SIDED|95.0|-10.1|25.7||||||Vaccine efficacy within 90 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||25.7|-10.1|
74030771|NCT01600131|147615517|SUPERIORITY||Slope|-1.08|STANDARD_ERROR_OF_MEAN|1.15||0.346|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.346
74030772|NCT01600131|147615519|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|1.79||0.688|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.688
74030773|NCT01600131|147615520|SUPERIORITY||Slope|-1.52|STANDARD_ERROR_OF_MEAN|1.87||0.418|TWO_SIDED|||||a priori \<.05|Mixed Models Analysis||group X time interaction|||||0.418
74030774|NCT01600131|147615521|SUPERIORITY||Slope|-1.94|STANDARD_ERROR_OF_MEAN|1.45||0.18|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.180
74030775|NCT01600131|147615522|SUPERIORITY||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.65||0.332|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.332
73938167|NCT01571362|147408082|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.188||0.0106|TWO_SIDED|95.0|-0.85|-0.11|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.11|-0.85|0.0106
73938168|NCT01571362|147408082|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.17|STANDARD_ERROR_OF_MEAN|0.222||0.4529|TWO_SIDED|95.0|-0.6|0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||0.27|-0.60|0.4529
73938169|NCT01571362|147408082|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.207||0.0018|TWO_SIDED|95.0|-1.06|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.25|-1.06|0.0018
73938170|NCT01571362|147408083|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.258||0.0061|TWO_SIDED|95.0|-1.22|-0.2|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.20|-1.22|0.0061
73938171|NCT01571362|147408083|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.277||0.0087|TWO_SIDED|95.0|-1.28|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.19|-1.28|0.0087
73938172|NCT01571362|147408083|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.315||0.0769|TWO_SIDED|95.0|-1.18|0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||0.06|-1.18|0.0769
73938173|NCT01571362|147408083|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.1|STANDARD_ERROR_OF_MEAN|0.289||0.0002|TWO_SIDED|95.0|-1.67|-0.53|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.53|-1.67|0.0002
73938174|NCT01571362|147408084|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.224||0.025|TWO_SIDED|95.0|-0.95|-0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.06|-0.95|0.0250
73938175|NCT01571362|147408084|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.234||0.0002|TWO_SIDED|95.0|-1.36|-0.43|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.43|-1.36|0.0002
73938176|NCT01571362|147408084|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.263||0.0038|TWO_SIDED|95.0|-1.29|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.25|-1.29|0.0038
73938177|NCT01571362|147408084|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.50|-1.46|<0.0001
73938178|NCT01571362|147408085|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.8|STANDARD_ERROR_OF_MEAN|0.214||0.0002|TWO_SIDED|95.0|-1.22|-0.38|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.38|-1.22|0.0002
73938179|NCT01571362|147408085|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.78|STANDARD_ERROR_OF_MEAN|0.235||0.001|TWO_SIDED|95.0|-1.25|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.32|-1.25|0.0010
73938180|NCT01571362|147408085|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.271||0.0041|TWO_SIDED|95.0|-1.32|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.25|-1.32|0.0041
73938181|NCT01571362|147408085|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.56|-1.52|<0.0001
73938182|NCT01571362|147408086|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.236||0.0115|TWO_SIDED|95.0|-1.06|-0.14|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.14|-1.06|0.0115
74030776|NCT01600131|147615523|SUPERIORITY||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.56||0.318|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.318
74030777|NCT01600131|147615524|SUPERIORITY||Slope|2.33|STANDARD_ERROR_OF_MEAN|1.31||0.077|TWO_SIDED|||||a priori \<.05|Mixed Models Analysis||group X time interaction|||||0.077
73938183|NCT01571362|147408086|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.256||0.0099|TWO_SIDED|95.0|-1.17|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.16|-1.17|0.0099
73938184|NCT01571362|147408086|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.307||0.0222|TWO_SIDED|95.0|-1.31|-0.1|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.10|-1.31|0.0222
73938185|NCT01571362|147408086|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.264||0.0001|TWO_SIDED|95.0|-1.54|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.||-0.50|-1.54|0.0001
73938186|NCT01571362|147408087|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.218||0.0025|TWO_SIDED|95.0|-1.09|-0.24|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.24|-1.09|0.0025
73938187|NCT01571362|147408087|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.235||0.0012|TWO_SIDED|95.0|-1.23|-0.31|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.31|-1.23|0.0012
73938188|NCT01571362|147408087|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.272||0.0078|TWO_SIDED|95.0|-1.27|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.19|-1.27|0.0078
73938189|NCT01571362|147408087|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.56|-1.52|<0.0001
73938190|NCT01571362|147408088|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.228||0.0727|TWO_SIDED|95.0|-0.86|0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||0.04|-0.86|0.0727
73938191|NCT01571362|147408088|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.238||0.0501|TWO_SIDED|95.0|-0.94|0.0|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||0.00|-0.94|0.0501
73938192|NCT01571362|147408088|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.262||0.5704|TWO_SIDED|95.0|-0.67|0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||0.37|-0.67|0.5704
73938193|NCT01571362|147408088|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.245||0.0096|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.||-0.16|-1.12|0.0096
73938194|NCT01571362|147408089|SUPERIORITY_OR_OTHER||Difference of LS Means|-27.75|STANDARD_ERROR_OF_MEAN|10.968||0.012|TWO_SIDED|95.0|-49.34|-6.16|||ANCOVA||Difference between treatment groups evaluated by ANCOVA with treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|||-6.16|-49.34|0.0120
73938195|NCT01571362|147408090|SUPERIORITY_OR_OTHER||Difference of LS Means|-3.87|STANDARD_ERROR_OF_MEAN|50.5||0.939|TWO_SIDED|95.0|-103.29|95.55|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the average daily rescue acetaminophen during the Titration Period and final total daily study medication dose of the Titration Period as covariates.|||95.55|-103.29|0.9390
73938196|NCT01571362|147408096|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 20% loss of analgesic response||||0.0014
73938197|NCT01571362|147408096|SUPERIORITY_OR_OTHER|||||||0.0024|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 30% loss of analgesic response.||||0.0024
73938198|NCT01571362|147408096|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 40% loss of analgesic response.||||0.0006
73938199|NCT01571362|147408096|SUPERIORITY_OR_OTHER|||||||0.0021|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 50% loss of analgesic response||||0.0021
73938200|NCT01571362|147408098|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors.||||||0.006
73938201|NCT01571362|147408108|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to the End of Open-Label Titration Period.||||<0.0001
73938202|NCT01571362|147408109|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline.||||<0.0001
73938203|NCT01571362|147408110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05|STANDARD_ERROR_OF_MEAN|0.584||0.0733|TWO_SIDED|95.0|-2.2|0.1||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 2.||0.10|-2.20|0.0733
73938204|NCT01571362|147408110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.642||0.2783|TWO_SIDED|95.0|-1.96|0.57||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 4.||0.57|-1.96|0.2783
73938205|NCT01571362|147408110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.684||0.3951|TWO_SIDED|95.0|-0.77|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 8.||1.93|-0.77|0.3951
73938206|NCT01571362|147408110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.614||0.9063|TWO_SIDED|95.0|-1.14|1.28||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 12.||1.28|-1.14|0.9063
73938207|NCT01571362|147408111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.463||0.1139|TWO_SIDED|95.0|-1.65|0.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted change from Baseline to Week 2.||0.18|-1.65|0.1139
73938208|NCT01571362|147408111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.577||0.2264|TWO_SIDED|95.0|-1.84|0.44||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 4.||0.44|-1.84|0.2264
73938209|NCT01571362|147408111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.619||0.5074|TWO_SIDED|95.0|-0.81|1.63||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 8.||1.63|-0.81|0.5074
73938210|NCT01571362|147408112|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Bowker's test of symmetry|||||||<0.0001
73938211|NCT01571362|147408113|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Bowker's test of symmetry|||||||<0.0001
73938212|NCT01571362|147408114|SUPERIORITY_OR_OTHER|||||||0.2211|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.2211
73973488|NCT04424316|147489836|OTHER||Vaccine efficacy|6.7|||||TWO_SIDED|95.0|-9.8|20.7||||||Vaccine efficacy within 120 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||20.7|-9.8|
73938213|NCT01571362|147408115|SUPERIORITY_OR_OTHER|||||||0.5767|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.5767
73938214|NCT01571362|147408118|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.0004
73938215|NCT01571362|147408119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Functioning.||||<0.0001
73973489|NCT04424316|147489836|OTHER||Vaccine efficacy|7.7|||||TWO_SIDED|95.0|-6.5|20.1||||||Vaccine efficacy within 150 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||20.1|-6.5|
73938216|NCT01571362|147408119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Physical.||||<0.0001
73938217|NCT01571362|147408119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Bodily Pain.||||<0.0001
73938218|NCT01571362|147408119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for General Health.||||<0.0001
73938219|NCT01571362|147408119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Vitality.||||<0.0001
73938220|NCT01571362|147408119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Social Functioning.||||<0.0001
73938221|NCT01571362|147408119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Emotional.||||<0.0001
73938222|NCT01571362|147408119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Health.||||<0.0001
73938223|NCT01571362|147408119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Component Score.||||<0.0001
73938224|NCT01571362|147408119|SUPERIORITY_OR_OTHER|||||||0.0026|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Component Score.||||0.0026
73938225|NCT01571362|147408120|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health, Physical Component Score, and Mental Component Score||||<0.0001
73938226|NCT01571362|147408121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|0.952||0.5181|TWO_SIDED|95.0|-1.26|2.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Functioning.||2.49|-1.26|0.5181
73938227|NCT01571362|147408121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.998||0.9733|TWO_SIDED|95.0|-2.0|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Physical.||1.93|-2.00|0.9733
73938228|NCT01571362|147408121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|0.914||0.01|TWO_SIDED|95.0|0.57|4.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Bodily Pain.||4.18|0.57|0.0100
74030778|NCT01600131|147615525|SUPERIORITY||Slope|1.5|STANDARD_ERROR_OF_MEAN|1.46||0.305|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.305
74030779|NCT01600131|147615528|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.94||0.514|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.514
74030780|NCT01600131|147615529|SUPERIORITY||Slope|-1.61|STANDARD_ERROR_OF_MEAN|0.94||0.09|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.090
74030781|NCT01600131|147615530|SUPERIORITY||Slope|6.71|STANDARD_ERROR_OF_MEAN|2.57||0.009|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.009
73938229|NCT01571362|147408121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.764||0.4712|TWO_SIDED|95.0|-2.06|0.95||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for General Health Perceptions.||0.95|-2.06|0.4712
73938230|NCT01571362|147408121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.16|STANDARD_ERROR_OF_MEAN|1.091||0.2898|TWO_SIDED|95.0|-3.3|0.99||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Vitality.||0.99|-3.30|0.2898
73938231|NCT01571362|147408121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|1.044||0.1565|TWO_SIDED|95.0|-0.57|3.54||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Social Functioning.||3.54|-0.57|0.1565
73938232|NCT01571362|147408121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|1.348||0.522|TWO_SIDED|95.0|-3.52|1.79||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Emotional.||1.79|-3.52|0.5220
73938233|NCT01571362|147408121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.995||0.9865|TWO_SIDED|95.0|-1.94|1.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Health.||1.98|-1.94|0.9865
73938234|NCT01571362|147408121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.885||0.2491|TWO_SIDED|95.0|-0.72|2.77||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Component Score.||2.77|-0.72|0.2491
73938235|NCT01571362|147408121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|1.073||0.5219|TWO_SIDED|95.0|-2.8|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Component Score.||1.43|-2.80|0.5219
73938236|NCT01571362|147408122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.111||0.1731|TWO_SIDED|95.0|-0.67|3.71||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Functioning.||3.71|-0.67|0.1731
74030782|NCT01600131|147615531|SUPERIORITY||Slope|4.29|STANDARD_ERROR_OF_MEAN|3.53||0.225|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.225
73866761|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-3.34|3.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.82|-3.34|
73938237|NCT01571362|147408122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.127||0.329|TWO_SIDED|95.0|-1.12|3.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Physical.||3.32|-1.12|0.3290
73938238|NCT01571362|147408122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|1.047||0.0232|TWO_SIDED|95.0|0.33|4.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Bodily Pain.||4.45|0.33|0.0232
73938239|NCT01571362|147408122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.858||0.8139|TWO_SIDED|95.0|-1.89|1.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for General Health Perceptions.||1.49|-1.89|0.8139
73938240|NCT01571362|147408122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|1.117||0.6878|TWO_SIDED|95.0|-2.65|1.75||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Vitality.||1.75|-2.65|0.6878
73938241|NCT01571362|147408122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.08||0.0658|TWO_SIDED|95.0|-0.13|4.12||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Social Functioning.||4.12|-0.13|0.0658
73938242|NCT01571362|147408122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|1.374||0.867|TWO_SIDED|95.0|-2.48|2.94||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Emotional.||2.94|-2.48|0.8670
73938243|NCT01571362|147408122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|1.056||0.7259|TWO_SIDED|95.0|-1.71|2.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Health.||2.45|-1.71|0.7259
73938244|NCT01571362|147408122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|1.007||0.0989|TWO_SIDED|95.0|-0.32|3.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Component Score.||3.65|-0.32|0.0989
74030783|NCT01600131|147615532|SUPERIORITY||Slope|3.75|STANDARD_ERROR_OF_MEAN|4.89||0.443|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.443
74030784|NCT01600131|147615533|SUPERIORITY||Slope|7.39|STANDARD_ERROR_OF_MEAN|5.23||0.158|TWO_SIDED||||||Mixed Models Analysis||group x time interaction|||||0.158
74030785|NCT01600131|147615534|SUPERIORITY||Slope|7.28|STANDARD_ERROR_OF_MEAN|3.64||0.046|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.046
73866762|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-2.75|4.28||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.28|-2.75|
74030786|NCT01600131|147615535|SUPERIORITY||Slope|5.54|STANDARD_ERROR_OF_MEAN|3.83||0.149|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.149
74030787|NCT01600131|147615536|SUPERIORITY||Slope|4.16|STANDARD_ERROR_OF_MEAN|1.95||0.034|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.034
74030788|NCT01600131|147615537|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|1.52||0.846|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.846
74030789|NCT01600131|147615538|SUPERIORITY||Slope|1.67|STANDARD_ERROR_OF_MEAN|2.17||0.0442|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||.0442
74030790|NCT01600131|147615539|SUPERIORITY||Slope|1.98|STANDARD_ERROR_OF_MEAN|1.88||0.293|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.293
74030791|NCT00406315|147615566|SUPERIORITY_OR_OTHER_LEGACY||One-sided upper confidence limit|-0.53|||||ONE_SIDED|95.0|||||||A one-sided 95% confidence interval (CI) was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16.||||
74030792|NCT00406315|147615566|SUPERIORITY_OR_OTHER_LEGACY||One-sided upper confidence limit|-0.33|||||ONE_SIDED|95.0|||||||A one-sided 95% CI was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16 LOCF. Based on past information, the standard deviation of the mean weight difference was expected to be 2.2. The sample size of the study was estimated so that the one-sided CI of the mean weight decrease has a certain width. To obtain a one-sided CI with a width of 0.27 kg, a sample size of 180 subjects was needed. In other words, we were 95% certain that the true mean weight decrease was in an interval starting from the observed weight decrease and extending 0.27 kg unit above it.||||
74030793|NCT00406315|147615567|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.0|||||TWO_SIDED|95.0|-8.48|2.41||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.41|-8.48|
74030794|NCT00406315|147615568|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.2|||||TWO_SIDED|95.0|-1.82|1.44||||||HDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||1.44|-1.82|
74030795|NCT00406315|147615568|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.5|||||TWO_SIDED|95.0|-7.07|2.09||||||LDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.09|-7.07|
74030796|NCT00406315|147615568|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.6|||||TWO_SIDED|95.0|-16.44|13.15||||||Triglycerides. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||13.15|-16.44|
74030797|NCT00406315|147615569|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.1|||||TWO_SIDED|95.0|-0.02|0.14||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.14|-0.02|
74030798|NCT00406315|147615570|SUPERIORITY_OR_OTHER_LEGACY||Mean|3.0|||||TWO_SIDED|95.0|-0.09|6.15||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||6.15|-0.09|
74030799|NCT00406315|147615571|SUPERIORITY_OR_OTHER_LEGACY||Mean|134.8|||||TWO_SIDED|95.0|-20.43|289.98||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||289.98|-20.43|
74030800|NCT00406315|147615572|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.9|||||TWO_SIDED|95.0|-5.93|0.11||||||Waist. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.11|-5.93|
74030801|NCT00406315|147615572|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.0|||||TWO_SIDED|95.0|-6.2|0.1||||||Hip. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.10|-6.20|
74030802|NCT00406315|147615573|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.05|||||TWO_SIDED|95.0|-0.32|0.42||||||Total Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.42|-0.32|
74030803|NCT00406315|147615573|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.03|||||TWO_SIDED|95.0|-0.05|0.11||||||Global Severity Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.11|-0.05|
74030804|NCT00406315|147615573|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.01|||||TWO_SIDED|95.0|-0.06|0.07||||||Global Incapacitation Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.07|-0.06|
74030805|NCT00406315|147615574|SUPERIORITY_OR_OTHER_LEGACY||Mean|-10.22|||||TWO_SIDED|95.0|-12.7|-7.75||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-7.75|-12.70|
74030806|NCT00406315|147615574|SUPERIORITY_OR_OTHER_LEGACY||Mean|-6.61|||||TWO_SIDED|95.0|-8.59|-4.63||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-4.63|-8.59|
74030807|NCT00406315|147615574|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.3|||||TWO_SIDED|95.0|-4.07|-2.53||||||Positive Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-2.53|-4.07|
74030808|NCT00406315|147615574|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.43|||||TWO_SIDED|95.0|-3.03|-1.83||||||Positive Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-1.83|-3.03|
74030809|NCT00406315|147615574|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.67|||||TWO_SIDED|95.0|-2.36|-0.99||||||Negative Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.99|-2.36|
74030810|NCT00406315|147615574|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.92|||||TWO_SIDED|95.0|-1.48|-0.35||||||Negative Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.35|-1.48|
74030811|NCT00406315|147615575|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.76|||||TWO_SIDED|95.0|-0.9|-0.61||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.61|-0.90|
73866763|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.31|||||TWO_SIDED|95.0|-4.88|2.27||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.27|-4.88|
74030812|NCT00406315|147615575|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.47|||||TWO_SIDED|95.0|-0.58|-0.36||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.36|-0.58|
73938245|NCT01571362|147408122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.142||0.9969|TWO_SIDED|95.0|-2.25|2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Component Score.||2.25|-2.25|0.9969
74030813|NCT00406315|147615576|SUPERIORITY_OR_OTHER_LEGACY||Mean|2.7|||||TWO_SIDED|95.0|2.52|2.88||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.88|2.52|
73938246|NCT01571362|147408123|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73938247|NCT01571362|147408124|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73938248|NCT01571362|147408125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73938249|NCT01571362|147408126|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73938250|NCT01571362|147408127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.032|STANDARD_ERROR_OF_MEAN|0.0168||0.0605|TWO_SIDED|95.0|-0.001|0.065||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA|||||0.065|-0.001|0.0605
73938251|NCT01571362|147408128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|1.999||0.7196|TWO_SIDED|95.0|-3.22|4.66||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors; Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA|||||4.66|-3.22|0.7196
73938252|NCT01571362|147408129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.0172||0.228|TWO_SIDED|95.0|-0.013|0.055||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||||0.055|-0.013|0.2280
73938253|NCT01571362|147408130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|2.048||0.2701|TWO_SIDED|95.0|-1.77|6.3||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||||6.30|-1.77|0.2701
73938254|NCT01571362|147408131|SUPERIORITY_OR_OTHER|||||||0.3822|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Work Time Missed due to Low Back Pain.||||0.3822
73938255|NCT01571362|147408131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Impairment while Working due to Low Back Pain.||||<0.0001
73938256|NCT01571362|147408131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Overall Work Impairment due to Low Back Pain.||||<0.0001
73938257|NCT01571362|147408131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Activity Impairment due to Low Back Pain.||||<0.0001
73938258|NCT01571362|147408132|SUPERIORITY_OR_OTHER|||||||0.0017|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Work Time Missed due to Low Back Pain||||0.0017
73938259|NCT01571362|147408132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Impairment while Working due to Low Back Pain||||<0.0001
73938260|NCT01571362|147408132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Overall Work Impairment due to Low Back Pain||||<0.0001
73938261|NCT01571362|147408132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Activity Impairment due to Low Back Pain||||<0.0001
73938262|NCT01571362|147408133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.31|STANDARD_ERROR_OF_MEAN|2.883||0.1389|TWO_SIDED|95.0|-10.06|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||1.43|-10.06|0.1389
73938263|NCT01571362|147408133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.88|STANDARD_ERROR_OF_MEAN|4.34||0.5094|TWO_SIDED|95.0|-11.56|5.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||5.80|-11.56|0.5094
73938264|NCT01571362|147408133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.77|STANDARD_ERROR_OF_MEAN|4.043||0.4944|TWO_SIDED|95.0|-10.81|5.26||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||5.26|-10.81|0.4944
74030814|NCT00406315|147615576|SUPERIORITY_OR_OTHER_LEGACY||Mean|3.2|||||TWO_SIDED|95.0|3.02|3.34||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||3.34|3.02|
74030815|NCT00406315|147615577|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.55|||||TWO_SIDED|95.0|-3.27|-1.83||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-1.83|-3.27|
73938265|NCT01571362|147408134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.76|STANDARD_ERROR_OF_MEAN|4.295||0.1201|TWO_SIDED|95.0|-15.33|1.81||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||1.81|-15.33|0.1201
73938266|NCT01571362|147408134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.99|STANDARD_ERROR_OF_MEAN|5.288||0.3497|TWO_SIDED|95.0|-15.6|5.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||5.62|-15.60|0.3497
73973490|NCT04424316|147489836|OTHER||Vaccine efficacy|4.1|||||TWO_SIDED|95.0|-9.5|16.0||||||Vaccine efficacy within 180 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||16.0|-9.5|
73973491|NCT04424316|147489836|OTHER||Vaccine efficacy|4.6|||||TWO_SIDED|95.0|-6.6|14.6||||||Vaccine efficacy within 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||14.6|-6.6|
73973492|NCT04424316|147489837|OTHER||Vaccine efficacy|43.8|||||TWO_SIDED|95.0|25.6|57.7||||||Vaccine efficacy at 210 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||57.7|25.6|
73973493|NCT04424316|147489837|OTHER||Vaccine efficacy|39.7|||||TWO_SIDED|95.0|21.3|54.1||||||Vaccine efficacy at 240 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||54.1|21.3|
73938267|NCT01571362|147408134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.38|STANDARD_ERROR_OF_MEAN|4.532||0.6008|TWO_SIDED|95.0|-11.41|6.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||6.65|-11.41|0.6008
73973494|NCT04424316|147489837|OTHER||Vaccine efficacy|35.0|||||TWO_SIDED|95.0|16.1|49.9||||||Vaccine efficacy at 270 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||49.9|16.1|
73973495|NCT04424316|147489837|OTHER||Vaccine efficacy|33.0|||||TWO_SIDED|95.0|15.2|47.1||||||Vaccine efficacy at 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||47.1|15.2|
73973496|NCT00412607|147489838|SUPERIORITY_OR_OTHER_LEGACY||Percentage of mortality|13.3|||||ONE_SIDED|95.0||17.5|||Fisher Exact||The 95% confidence interval is a one-sided with upper confidence level = 17.5% computed using the exact binomial test.|"Assumptions for sample size calculation: 10% attrition rate, Type I error of 0.05, anticipated 12-month mortality rate is 0.19, a region of indifference of 0.07, power of 0.8; the required sample size is 249 per nQuery Exact test for single proportion method.~The null hypothesis is that the 12-month mortality rate is greater than or equal to 0.26; the alternative is that the rate is less than 0.26. This hypothesis is evaluated with one-sided exact binomial test at α= 0.05."||17.5||
73973497|NCT03995979|147489872|SUPERIORITY|||||||0.05||||||The P-value was calculated using a paired t test|Paired t-test|||A compositional analysis with species-level alpha diversity will be performed between the three conditions (Pre-Dietary Restriction, Dietary Restriction, and Post-Dietary Restriction,) with ANOVA testing. Furthermore, a differential abundance analysis will be performed to further identify and confirm prevalent organisms associated with the experimental dietary restriction.||||0.05
73973498|NCT05683158|147489923|OTHER||Mean Difference (Net)|1.71|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED||||||ANOVA||Mean difference between two groups of movement unit in forward direction|To determine the sample size, the G\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.||||<.001
74030816|NCT00406315|147615577|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.58|||||TWO_SIDED|95.0|-2.16|-0.99||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.99|-2.16|
73938268|NCT01571362|147408135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.34|STANDARD_ERROR_OF_MEAN|4.986||0.1458|TWO_SIDED|95.0|-17.29|2.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||2.62|-17.29|0.1458
73938269|NCT01571362|147408135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.35|STANDARD_ERROR_OF_MEAN|6.496||0.1558|TWO_SIDED|95.0|-22.38|3.68||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||3.68|-22.38|0.1558
73938270|NCT01571362|147408135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.14|STANDARD_ERROR_OF_MEAN|5.582||0.3604|TWO_SIDED|95.0|-16.25|5.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||5.98|-16.25|0.3604
73973499|NCT05683158|147489923|OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED||||||ANOVA||Statistics difference among forward, ipsilateral and contralateral directions in within group|To determine the sample size, the G\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.||||<.001
73973500|NCT04631016|147489937|OTHER||LS Mean Difference|0.024||||0.216|TWO_SIDED|80.0|-0.015|0.063|||Mixed Models Analysis|||||0.063|-0.015|0.216
73938271|NCT01571362|147408136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.25|STANDARD_ERROR_OF_MEAN|2.389||0.0768|TWO_SIDED|95.0|-8.95|0.46||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||0.46|-8.95|0.0768
73938272|NCT01571362|147408136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.684||0.7109|TWO_SIDED|95.0|-4.3|6.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||6.29|-4.30|0.7109
73938273|NCT01571362|147408136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.15|STANDARD_ERROR_OF_MEAN|2.536||0.1031|TWO_SIDED|95.0|-9.14|0.85||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||0.85|-9.14|0.1031
73938274|NCT01571362|147408137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.73|STANDARD_ERROR_OF_MEAN|2.776||0.0926|TWO_SIDED|95.0|-10.26|0.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||0.80|-10.26|0.0926
73938275|NCT01571362|147408137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.59|STANDARD_ERROR_OF_MEAN|3.414||0.6437|TWO_SIDED|95.0|-8.42|5.24||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||5.24|-8.42|0.6437
73938276|NCT01571362|147408137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|3.391||0.748|TWO_SIDED|95.0|-7.84|5.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||5.65|-7.84|0.7480
73938277|NCT01571362|147408138|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.38|STANDARD_ERROR_OF_MEAN|4.666||0.0098|TWO_SIDED|95.0|-21.68|-3.07||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-3.07|-21.68|0.0098
73938278|NCT01571362|147408138|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.94|STANDARD_ERROR_OF_MEAN|5.336||0.0186|TWO_SIDED|95.0|-23.63|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||-2.25|-23.63|0.0186
73938279|NCT01571362|147408138|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.2|STANDARD_ERROR_OF_MEAN|4.785||0.0581|TWO_SIDED|95.0|-18.72|0.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||0.32|-18.72|0.0581
73938280|NCT01571362|147408139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.56|STANDARD_ERROR_OF_MEAN|5.168||0.0177|TWO_SIDED|95.0|-22.87|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-2.25|-22.87|0.0177
73938281|NCT01571362|147408139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.16|STANDARD_ERROR_OF_MEAN|5.998||0.0219|TWO_SIDED|95.0|-26.19|-2.14||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||-2.14|-26.19|0.0219
73938282|NCT01571362|147408139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.35|STANDARD_ERROR_OF_MEAN|5.589||0.0679|TWO_SIDED|95.0|-21.47|0.78||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||0.78|-21.47|0.0679
73938283|NCT01571362|147408140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.654||0.0052|TWO_SIDED|95.0|-12.72|-2.27||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-2.27|-12.72|0.0052
73938284|NCT01571362|147408140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.62|STANDARD_ERROR_OF_MEAN|2.999||0.1249|TWO_SIDED|95.0|-10.54|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||1.29|-10.54|0.1249
73938285|NCT01571362|147408140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.19|STANDARD_ERROR_OF_MEAN|2.818||0.004|TWO_SIDED|95.0|-13.74|-2.64||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||-2.64|-13.74|0.0040
73938286|NCT01221597|147408175|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||ANOVA|||||||0.0005
73938287|NCT01221597|147408176|SUPERIORITY_OR_OTHER|||||||0.0451|TWO_SIDED||||||ANOVA|||||||0.0451
73938288|NCT01221597|147408177|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
73938289|NCT01221597|147408178|SUPERIORITY_OR_OTHER|||||||0.0268|TWO_SIDED||||||ANOVA|||||||0.0268
73938290|NCT01221597|147408179|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANOVA|||||||0.0800
73938291|NCT01221597|147408180|SUPERIORITY_OR_OTHER|||||||0.3085|TWO_SIDED||||||ANOVA|||||||0.3085
73938292|NCT01221597|147408181|SUPERIORITY_OR_OTHER|||||||0.6321|TWO_SIDED||||||ANOVA|||||||0.6321
73938293|NCT01221597|147408182|SUPERIORITY_OR_OTHER|||||||0.7965|TWO_SIDED||||||ANOVA|||||||0.7965
73938294|NCT01221597|147408183|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
73938295|NCT04642638|147408219|OTHER||Difference in median|6.7|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|0.0|6.7|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% confidence interval (CI).|||6.70|0.00|
73938296|NCT04642638|147408219|OTHER||Difference in median|13.3|STANDARD_ERROR_OF_MEAN|10.55|||TWO_SIDED|95.0|3.3|17.8|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI.|||17.80|3.30|
73938297|NCT04642638|147408219|OTHER||Difference in median|-6.6|STANDARD_ERROR_OF_MEAN|-5.0|||TWO_SIDED|95.0|-10.0|0.0|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI.|||0.00|-10.00|
73938298|NCT04642638|147408220|OTHER||Geometric Mean Fold Rise (GMFR) Ratio|2.5|||||TWO_SIDED|95.0|1.72|3.632|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons.|||3.632|1.720|
73938299|NCT04642638|147408220|OTHER||GMFR Ratio|3.88|||||TWO_SIDED|95.0|2.638|5.7|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons.|||5.700|2.638|
73938300|NCT04642638|147408220|OTHER||GMFR Ratio|0.68|||||TWO_SIDED|95.0|0.512|0.893|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons|||0.893|0.512|
73866764|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.25|||||TWO_SIDED|95.0|-1.32|5.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.82|-1.32|
73866765|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.01|||||TWO_SIDED|95.0|-5.89|1.87||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.87|-5.89|
73866766|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.49|||||TWO_SIDED|95.0|-2.41|5.4||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.40|-2.41|
73866767|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.45|||||TWO_SIDED|95.0|-2.44|5.34||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.34|-2.44|
73866768|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.89|||||TWO_SIDED|95.0|-1.98|5.76||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.76|-1.98|
73866769|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|-3.16|4.61||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.61|-3.16|
73866770|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.18|||||TWO_SIDED|95.0|0.29|8.06||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.06|0.29|
73866771|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-7.21|-0.06||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.06|-7.21|
73866772|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-6.25|0.85||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.85|-6.25|
73866773|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.01|||||TWO_SIDED|95.0|-5.63|1.6||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.60|-5.63|
73938301|NCT02085408|147408256|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.94|1.3|||Regression, Cox||Hazard ratio : clofarabine/(daunorubicin \& cytarabine)|||1.30|0.94|
73938302|NCT02085408|147408257|SUPERIORITY|||||||0.94|||||||Fisher Exact|||||||0.94
73866774|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49|||||TWO_SIDED|95.0|-5.02|2.05||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.05|-5.02|
73866775|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.19|||||TWO_SIDED|95.0|-10.07|-2.31||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.31|-10.07|
73866776|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.69|||||TWO_SIDED|95.0|-6.6|1.23||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.23|-6.60|
73866777|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73|||||TWO_SIDED|95.0|-6.64|1.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.18|-6.64|
73866778|NCT01393639|147278703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.29|||||TWO_SIDED|95.0|-6.16|1.58||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.58|-6.16|
73938303|NCT03317977|147408272|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
73938304|NCT05525494|147408336|SUPERIORITY||Adjusted Risk Ratio|0.99|||||TWO_SIDED|95.0|0.98|1.01|||||Adjusted risk ratio. These results compare arms which received portal (any type) reminder/recall messages to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
73973501|NCT04631016|147489940|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.186|TWO_SIDED|80.0|0.57|1.11|||Regression, Cox|||||1.11|0.57|0.186
74030817|NCT00406315|147615578|SUPERIORITY_OR_OTHER_LEGACY||Mean|-4.61|||||TWO_SIDED|95.0|-5.95|-3.26||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-3.26|-5.95|
73938305|NCT05525494|147408336|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||||Adjusted risk ratio. These results compare arms which received text (any type) reminder/recall messages to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
73938306|NCT05525494|147408336|SUPERIORITY||Adjusted Risk Ratio|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Adjusted risk ratio. These results compare arms which received pre-appointment reminder/recall messages (portal and text) to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.02|1.00|
73938307|NCT05525494|147408336|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Adjusted risk ratio. These results compare arms which received a tailored reminder/recall messages based on their responses to a pre-commitment questionnaire (any type) to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.99|
73938308|NCT00762320|147408342|SUPERIORITY_OR_OTHER||||||=|0.004|||||||t-test, 2 sided|df=4||||||=.004
73938309|NCT00762320|147408347|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|df=7||||||<.001
73938310|NCT02512575|147408472|SUPERIORITY_OR_OTHER||Slope|0.847|STANDARD_ERROR_OF_MEAN|0.0238|||TWO_SIDED|90.0|0.807|0.887||||||||0.887|0.807|
73938311|NCT02512575|147408475|SUPERIORITY_OR_OTHER||Slope|0.93|STANDARD_ERROR_OF_MEAN|0.0364|||TWO_SIDED|90.0|0.869|0.991||||||||0.991|0.869|
74030818|NCT00406315|147615578|SUPERIORITY_OR_OTHER_LEGACY||Mean|-4.21|||||TWO_SIDED|95.0|-5.57|-2.85||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-2.85|-5.57|
73938312|NCT02512575|147408476|SUPERIORITY_OR_OTHER||Slope|0.917|STANDARD_ERROR_OF_MEAN|0.0364|||TWO_SIDED|90.0|0.856|0.978||||||||0.978|0.856|
73938313|NCT02512575|147408477|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.03|||||TWO_SIDED|90.0|0.96|1.11||||||||1.11|0.960|
73938314|NCT02512575|147408477|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.0|||||TWO_SIDED|90.0|0.929|1.08||||||||1.08|0.929|
73938315|NCT02512575|147408477|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.06|||||TWO_SIDED|90.0|0.987|1.14||||||||1.14|0.987|
73938316|NCT02512575|147408477|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.06|||||TWO_SIDED|95.0|0.983|1.13||||||||1.13|0.983|
73938317|NCT02512575|147408477|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.07|||||TWO_SIDED|90.0|0.995|1.15||||||||1.15|0.995|
73938318|NCT02512575|147408477|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.17|||||TWO_SIDED|90.0|1.09|1.25||||||||1.25|1.09|
73938319|NCT02512575|147408477|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.15|||||TWO_SIDED|90.0|1.07|1.24||||||||1.24|1.07|
73938320|NCT02512575|147408477|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.2|||||TWO_SIDED|90.0|1.11|1.29||||||||1.29|1.11|
73938321|NCT02512575|147408477|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.19|||||TWO_SIDED|90.0|1.11|1.27||||||||1.27|1.11|
73938322|NCT02512575|147408478|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.05|||||TWO_SIDED|90.0|0.872|1.26||||||||1.26|0.872|
73938323|NCT02512575|147408478|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.05|||||TWO_SIDED|90.0|0.874|1.26||||||||1.26|0.874|
73938324|NCT02512575|147408478|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.907|||||TWO_SIDED|90.0|0.745|1.1||||||||1.10|0.745|
73938325|NCT02512575|147408478|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.914|||||TWO_SIDED|90.0|0.762|1.1||||||||1.10|0.762|
73938326|NCT02512575|147408478|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.876|||||TWO_SIDED|90.0|0.728|1.05||||||||1.05|0.728|
73938327|NCT02512575|147408478|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.86|||||TWO_SIDED|90.0|0.716|1.03||||||||1.03|0.716|
73938328|NCT02512575|147408478|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.01|||||TWO_SIDED|90.0|0.842|1.21||||||||1.21|0.842|
73938329|NCT02512575|147408478|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.02|||||TWO_SIDED|90.0|0.846|1.22||||||||1.22|0.846|
73938330|NCT02512575|147408478|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.687|||||TWO_SIDED|90.0|0.572|0.825||||||||0.825|0.572|
73938331|NCT02512575|147408479|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.982|||||TWO_SIDED|90.0|0.861|1.12||||||||1.12|0.861|
73938332|NCT02512575|147408479|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.961||||||90.0|0.846|1.09||||||||1.09|0.846|
73938333|NCT02512575|147408479|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.942|||||TWO_SIDED|90.0|0.829|1.07||||||||1.07|0.829|
73938334|NCT02512575|147408479|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.861|||||TWO_SIDED|90.0|0.757|0.979||||||||0.979|0.757|
73938335|NCT02512575|147408479|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.848|||||TWO_SIDED|90.0|0.745|0.964||||||||0.964|0.745|
73938336|NCT02512575|147408479|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.927|||||TWO_SIDED|90.0|0.815|1.05||||||||1.05|0.815|
73938337|NCT02512575|147408479|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.907|||||TWO_SIDED|90.0|0.798|1.03||||||||1.03|0.798|
73938338|NCT02512575|147408479|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.893|||||TWO_SIDED|90.0|0.784|1.02||||||||1.02|0.784|
73938339|NCT02512575|147408479|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.691||||||90.0|0.608|0.785||||||||0.785|0.608|
73938340|NCT04773587|147408503|SUPERIORITY||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|1.881|4.647|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Difference in vIGA-AD Success at Week 4||4.647|1.881|<0.0001
73938341|NCT04773587|147408504|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|1.64|4.359|||Cochran-Mantel-Haenszel|Stratified by pooled study site with multiple imputation of missing observations|Stratified by pooled study site with multiple imputation of missing observations|Difference in vIGA-AD Success at Week 4||4.359|1.640|<0.0001
74030819|NCT00406315|147615578|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.02|||||TWO_SIDED|95.0|-1.31|-0.73||||||Global Rating, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.73|-1.31|
73938342|NCT04773587|147408505|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0089|TWO_SIDED|95.0|1.186|3.319|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 4||3.319|1.186|0.0089
73938343|NCT04773587|147408506|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0016|TWO_SIDED|95.0|1.45|5.457|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 2||5.457|1.450|0.0016
73938344|NCT04773587|147408507|SUPERIORITY||Odds Ratio (OR)|3.81||||0.0159|TWO_SIDED|95.0|1.161|12.511|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 1||12.511|1.161|0.0159
73938345|NCT04773587|147408508|SUPERIORITY||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|95.0|2.102|4.795|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|EASI-75 at Week 4||4.795|2.102|<0.0001
73938346|NCT04773587|147408509|SUPERIORITY||Odds Ratio (OR)|2.56|||<|0.0001|TWO_SIDED|95.0|1.707|3.843|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study stie and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4||3.843|1.707|<0.0001
73938347|NCT04773587|147408510|SUPERIORITY||Odds Ratio (OR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.31|7.926|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Success at Week 2||7.926|2.310|<0.0001
73938348|NCT04773587|147408511|SUPERIORITY||Odds Ratio (OR)|25.41|||<|0.0001|TWO_SIDED|95.0|2.815|229.388|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Success at Week 1||229.388|2.815|<0.0001
73973502|NCT04631016|147489961|SUPERIORITY||Least square mean difference|0.067||||0.044|TWO_SIDED|80.0|0.017|0.116||One-sided p-value|Mixed Models Analysis|Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.||Results are based on the mixed model for repeated measures (MMRM) analysis at Week 12.||0.116|0.017|0.044
73973503|NCT04631016|147489961|SUPERIORITY||Least square mean difference|0.07||||0.036|TWO_SIDED|80.0|0.02|0.12||One-sided p-value|Mixed Models Analysis|Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.||Results are based on the MMRM analysis at Week 28.||0.120|0.020|0.036
73938349|NCT04773587|147408512|SUPERIORITY||Odds Ratio (OR)|3.62|||<|0.0001|TWO_SIDED|95.0|2.217|5.911|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2||5.911|2.217|<0.0001
73938350|NCT04773587|147408513|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0002|TWO_SIDED|95.0|1.705|7.007|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1||7.007|1.705|0.0002
73938351|NCT01808313|147408523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.59|||<|0.001|TWO_SIDED|95.0|42.53|64.66|||t-test, 2 sided|||||64.66|42.53|<0.001
73938352|NCT01808313|147408524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.36|||<|0.001|TWO_SIDED|95.0|48.72|80.0|||t-test, 2 sided|||||80.00|48.72|<0.001
73938353|NCT01808313|147408526|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-rank test|||Week 12||||<0.001
73938354|NCT01808313|147408526|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon signed-rank test|||Week 24||||0.003
73938355|NCT01808313|147408527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|||<|0.001|TWO_SIDED|95.0|0.366|0.519|||Wilcoxon signed-rank test||Week 12|||0.519|0.366|<0.001
73938356|NCT01808313|147408527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|||<|0.001|TWO_SIDED|95.0|0.303|0.453|||Wilcoxon signed-rank test||Week 24|||0.453|0.303|<0.001
73938357|NCT03301051|147408571|OTHER|Vaccine Efficacy (VE) of VLP vaccine versus placebo = (1 - attack rate in vaccinated participants \[ARV\]/attack rate in unvaccinated participants \[ARU\]) x 100%.|Vaccine Efficacy|34.9|||||TWO_SIDED|95.0|17.6|48.6|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% confidence interval (CI).|||48.6|17.6|
73938358|NCT03301051|147408572|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|38.6|||||TWO_SIDED|95.0|27.6|48.0|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.0|27.6|
73938359|NCT03301051|147408573|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|33.8|||||TWO_SIDED|95.0|14.9|48.5|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.5|14.9|
73938360|NCT03301051|147408574|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|37.6|||||TWO_SIDED|95.0|25.1|48.0|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.0|25.1|
74008392|NCT03627767|147566507|SUPERIORITY||LSM difference|-5.5|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.6|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.6|-7.4|< 0.0001
73938361|NCT03301051|147408575|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|6.2|||||TWO_SIDED|95.0|0.8|11.3|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||11.3|0.8|
73938362|NCT00622167|147408601|SUPERIORITY_OR_OTHER|||||||0||0.0|||||Not done|||Plaque characteristics including plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology would be compared between IBIVUS, DSCT and angiography.||||0
73938363|NCT00435370|147408657|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||||||<0.05
73938364|NCT02298192|147408694|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D \<0.30%.|Treatment Contrast|0.12||||0.012|TWO_SIDED|95.0|-0.04|0.28|||Mixed Models Analysis|||The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D \<0.30%.||0.28|-0.04|0.012
73938365|NCT00765193|147408727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.01||95.0|2.12|2.62|||Regression, Logistic|||The primary outcomes were the calculation of the absolute and relative risks of missing a skin cancer when TBSE is not performed, as well as the number of patients needed to examine by TBSE to find a skin cancer. The secondary outcome was to assess the magnitude of false-positive results obtained by TBSE||2.62|2.12|<0.01
73938366|NCT04414696|147408749|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.3|1.5|||||Multivariable linear regression|||1.5|-3.3|
73938367|NCT04414696|147408750|SUPERIORITY||Mean Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-23.5|14.5|||||Multivariable linear regression|||14.5|-23.5|
73938368|NCT04414696|147408751|SUPERIORITY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-1.9|9.5||||||||9.5|-1.9|
73938369|NCT04414696|147408752|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-18.9|21.5|||||Multivariable linear regression|||21.5|-18.9|
74030820|NCT00406315|147615578|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.88|||||TWO_SIDED|95.0|-1.13|-0.63||||||Global Rating, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.63|-1.13|
74030821|NCT00406315|147615579|SUPERIORITY_OR_OTHER_LEGACY||Mean|7.88|||||TWO_SIDED|95.0|6.07|9.69||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.69|6.07|
74030822|NCT00406315|147615579|SUPERIORITY_OR_OTHER_LEGACY||Mean|5.27|||||TWO_SIDED|95.0|3.89|6.65||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||6.65|3.89|
74030823|NCT00406315|147615580|SUPERIORITY_OR_OTHER_LEGACY||Mean|10.49|||||TWO_SIDED|95.0|5.95|15.02||||||Effectiveness, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||15.02|5.95|
74030824|NCT00406315|147615580|SUPERIORITY_OR_OTHER_LEGACY||Mean|10.49|||||TWO_SIDED|95.0|5.95|15.02||||||Effectiveness, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||15.02|5.95|
73938370|NCT04414696|147408753|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.7|1.1|||||Multivariable linear regression|||1.1|-3.7|
73938371|NCT04414696|147408754|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-7.7|4.2|||||Multivariable linear regression|||4.2|-7.7|
73938372|NCT04414696|147408755|SUPERIORITY||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.2|2.1|||||Multivariable linear regression|||2.1|-1.2|
73938373|NCT04414696|147408756|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|1.1|||||Multivariable linear regression|||1.1|-1|
73938374|NCT04414696|147408757|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.4|1.2|||||Multivariable linear regression|||1.2|-3.4|
73938375|NCT04414696|147408758|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-4.9|1.3|||||Multivariable linear regression|||1.3|-4.9|
73938376|NCT05912400|147408763|OTHER||||||<|0.01||||||Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain).|Spearman's Rho|||||||<0.01
73938377|NCT05912400|147408763|OTHER|||||||0.02|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.02
73938378|NCT05912400|147408763|OTHER|||||||0.03|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.03
73938379|NCT05912400|147408763|OTHER|||||||0.88|||||||Spearman's Rho|Correlation: OCR (Oxygen Consumption Rate) and FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index)||||||0.88
73938380|NCT05912400|147408763|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and vitamin D levels.||||||0.36
73938381|NCT05912400|147408764|OTHER|||||||0.54|||||||Spearman's Rho|Spearman's rho used analyze correlation btwn ECAR (Extracellular Acidification Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain)||||||0.54
73938382|NCT05912400|147408764|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.36
73938383|NCT05912400|147408764|OTHER|||||||0.94|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.94
73938384|NCT05912400|147408764|OTHER|||||||0.53|||||||Spearman's Rho|Correlation: ECAR (Extracellular Acidification Rate) \& FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.53
73938385|NCT05912400|147408764|OTHER|||||||0.51|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between ECAR (Extracellular Acidification Rate) and vitamin D levels.||||||0.51
74030825|NCT00406315|147615580|SUPERIORITY_OR_OTHER_LEGACY||Mean|18.49|||||TWO_SIDED|95.0|11.94|25.04||||||Side Effect, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||25.04|11.94|
74030826|NCT00406315|147615580|SUPERIORITY_OR_OTHER_LEGACY||Mean|18.49|||||TWO_SIDED|95.0|11.94|25.04||||||Side Effect, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||25.04|11.94|
74030827|NCT00406315|147615580|SUPERIORITY_OR_OTHER_LEGACY||Mean|6.45|||||TWO_SIDED|95.0|2.98|9.93||||||Convenience, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.93|2.98|
74030828|NCT00406315|147615580|SUPERIORITY_OR_OTHER_LEGACY||Mean|6.45|||||TWO_SIDED|95.0|2.98|9.93||||||Convenience, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.93|2.98|
74030829|NCT00406315|147615580|SUPERIORITY_OR_OTHER_LEGACY||Mean|15.32|||||TWO_SIDED|95.0|9.97|20.68||||||Global Satisfaction, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||20.68|9.97|
73938386|NCT05912400|147408765|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and vitamin D levels.||||||0.36
73938387|NCT05912400|147408765|OTHER|||||||0.51|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between ECAR (Extracellular Acidification Rate) and vitamin D levels.||||||0.51
73938388|NCT05912400|147408766|OTHER||||||<|0.01|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain).||||||<0.01
73938389|NCT05912400|147408766|OTHER|||||||0.54|||||||Spearman's Rho|Spearman's rho used analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Current (Numeric Pain Rating Scale for current pain).||||||0.54
73938390|NCT05912400|147408767|OTHER|||||||0.02|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.02
73938391|NCT05912400|147408767|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.36
73938392|NCT05912400|147408768|OTHER|||||||0.03|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.03
73938393|NCT05912400|147408768|OTHER|||||||0.94|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.94
73938394|NCT05912400|147408769|OTHER|||||||0.88|||||||Spearman's Rho|Correlation: OCR (Oxygen Consumption Rate) and FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.88
73938395|NCT05912400|147408769|OTHER|||||||0.53|||||||Spearman's Rho|Correlation: ECAR (Extracellular Acidification Rate) \& FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.53
73938396|NCT02811861|147408784|SUPERIORITY||Stratified Hazard Ratio|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.8|||Stratified Log-rank Test|Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.||||0.80|0.53|<0.0001
73938397|NCT02811861|147408784|SUPERIORITY||Stratified Hazard Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.32|0.49|||Stratified Log-rank Test|Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.||||0.49|0.32|<0.0001
73938398|NCT01227681|147408810|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||Null hypothesis: there is significant deterioration of UPDRS part III scores from baseline to post G-CSF injection one year||||0.64
73938399|NCT02239679|147408811|SUPERIORITY|||||||0.0166|||||||ANCOVA|||||||0.0166
73938400|NCT02239679|147408817|SUPERIORITY|||||||0.0102||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0102
73938401|NCT02239679|147408817|SUPERIORITY|||||||0.0089||||||no adjustment for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0089
73938402|NCT02239679|147408818|SUPERIORITY|||||||0.0004||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0004
73938403|NCT02239679|147408818|SUPERIORITY||||||<|0.0001||||||no adjustment for multiple comparison|Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
73938404|NCT01217073|147408880|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.71|||<|0.001|TWO_SIDED|95.0|-0.93|-0.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.50|-0.93|<0.001
73938405|NCT01217073|147408880|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.67|||<|0.001|TWO_SIDED|95.0|-0.88|-0.45||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.45|-0.88|<0.001
73938406|NCT01217073|147408880|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.49|||<|0.001|TWO_SIDED|95.0|-0.7|-0.27||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.27|-0.70|<0.001
73938407|NCT01217073|147408880|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.5|||<|0.001|TWO_SIDED|95.0|-0.71|-0.28||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.28|-0.71|<0.001
73938408|NCT01217073|147408880|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.28||||0.012|TWO_SIDED|95.0|-0.5|-0.06||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.06|-0.50|0.012
73938409|NCT01217073|147408881|SUPERIORITY_OR_OTHER||Difference in percentage|6.2|||||TWO_SIDED|95.0|-6.2|18.4||||||||18.4|-6.2|
73938410|NCT01217073|147408881|SUPERIORITY_OR_OTHER||Difference in percentage|12.5|||||TWO_SIDED|95.0|-0.1|24.7||||||||24.7|-0.1|
73938411|NCT01217073|147408881|SUPERIORITY_OR_OTHER||Difference in percentage|5.9|||||TWO_SIDED|95.0|-6.5|18.0||||||||18.0|-6.5|
73938412|NCT01217073|147408881|SUPERIORITY_OR_OTHER||Difference in percentage|5.5|||||TWO_SIDED|95.0|-6.8|17.7||||||||17.7|-6.8|
73938413|NCT01217073|147408881|SUPERIORITY_OR_OTHER||Difference in percentage|2.4|||||TWO_SIDED|95.0|-9.8|14.5||||||||14.5|-9.8|
73938414|NCT01217073|147408882|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.1|4.1||||||||4.1|-4.1|
73866779|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.73|||||TWO_SIDED|95.0|-0.83|4.3||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.30|-0.83|
73938415|NCT01217073|147408882|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-4.9|2.4||||||||2.4|-4.9|
73938416|NCT01217073|147408882|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.1|4.0||||||||4.0|-4.1|
73938417|NCT01217073|147408882|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-4.9|2.4||||||||2.4|-4.9|
73938418|NCT01217073|147408882|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-1.7|7.9||||||||7.9|-1.7|
73938419|NCT01217073|147408883|SUPERIORITY_OR_OTHER||Difference in percent|1.0|||||TWO_SIDED|95.0|-9.8|13.1||||||||13.1|-9.8|
73938420|NCT01217073|147408884|SUPERIORITY_OR_OTHER||Difference in percent|-1.4|||||TWO_SIDED|95.0|-9.1|2.6||||||||2.6|-9.1|
73938421|NCT01217073|147408885|SUPERIORITY_OR_OTHER||Difference in least squares mean|-44.9|||<|0.001|TWO_SIDED|95.0|-59.0|-30.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-30.7|-59.0|<0.001
73938422|NCT01217073|147408885|SUPERIORITY_OR_OTHER||Difference in least squares mean|-41.6|||<|0.001|TWO_SIDED|95.0|-55.3|-27.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-27.8|-55.3|<0.001
73938423|NCT01217073|147408885|SUPERIORITY_OR_OTHER||Difference in least squares mean|-35.1|||<|0.001|TWO_SIDED|95.0|-48.9|-21.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-21.3|-48.9|<0.001
73938424|NCT01217073|147408885|SUPERIORITY_OR_OTHER||Difference in least squares mean|-33.5|||<|0.001||95.0|-47.3|-19.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-19.7|-47.3|<0.001
73938425|NCT01217073|147408885|SUPERIORITY_OR_OTHER||Difference in least squares mean|-18.8||||0.009|TWO_SIDED|95.0|-32.9|-4.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-4.8|-32.9|0.009
73938426|NCT01217073|147408886|SUPERIORITY_OR_OTHER||Difference in least squares mean|-21.4|||<|0.001|TWO_SIDED|95.0|-29.4|-13.4||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-13.4|-29.4|<0.001
73938427|NCT01217073|147408886|SUPERIORITY_OR_OTHER||Difference in least squares mean|-13.5|||<|0.001|TWO_SIDED|95.0|-21.3|-5.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-5.7|-21.3|<0.001
73938428|NCT01217073|147408886|SUPERIORITY_OR_OTHER||Difference in least squares mean|-14.3|||<|0.001|TWO_SIDED|95.0|-22.2|-6.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-6.3|-22.2|<0.001
73938429|NCT01217073|147408886|SUPERIORITY_OR_OTHER||Difference in least squares mean|-19.0|||<|0.001|TWO_SIDED|95.0|-26.9|-11.2||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-11.2|-26.9|<0.001
73938430|NCT01217073|147408886|SUPERIORITY_OR_OTHER||Difference in least squares mean|-2.5||||0.539|TWO_SIDED|95.0|-10.4|5.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||5.5|-10.4|0.539
73938431|NCT00373334|147408946|SUPERIORITY_OR_OTHER|||||||0.528||95.0|||||Cochran-Mantel-Haenszel|||||||0.528
73938432|NCT00373334|147408946|SUPERIORITY_OR_OTHER|||||||0.341||95.0|||||Cochran-Mantel-Haenszel|||||||0.341
73938433|NCT00373334|147408947|SUPERIORITY_OR_OTHER|||||||0.746||95.0|||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.746
73938434|NCT00373334|147408947|SUPERIORITY_OR_OTHER|||||||0.262||95.0|||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.262
73938435|NCT00373334|147408948|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.609
73938436|NCT00373334|147408948|SUPERIORITY_OR_OTHER|||||||0.938||95.0|||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.938
73938437|NCT02479412|147409047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02691|STANDARD_ERROR_OF_MEAN|0.05697||0.6379|TWO_SIDED|95.0|-0.08626|0.1401|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||0.1401|-0.08626|0.6379
73938438|NCT02479412|147409047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07604|STANDARD_ERROR_OF_MEAN|0.05663||0.1827|TWO_SIDED|95.0|-0.03645|0.1885|||Mixed Models Analysis|||AZD7594 250 µg vs.PBO||0.1885|-0.03645|0.1827
73938439|NCT02479412|147409047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1478|STANDARD_ERROR_OF_MEAN|0.05679||0.0108|TWO_SIDED|95.0|0.03494|0.2606|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.2606|0.03494|0.0108
73866780|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|0.35|5.45||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.45|0.35|
73866781|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.12|||||TWO_SIDED|95.0|3.54|8.7||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.70|3.54|
73866782|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.73|||||TWO_SIDED|95.0|2.19|7.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.26|2.19|
73866783|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.18|||||TWO_SIDED|95.0|-0.39|4.76||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.76|-0.39|
73866784|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.41|||||TWO_SIDED|95.0|2.83|7.99||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.99|2.83|
73866785|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-1.08|4.65||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.65|-1.08|
73866786|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4|||||TWO_SIDED|95.0|1.52|7.28||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.28|1.52|
73938440|NCT02479412|147409048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.857|STANDARD_ERROR_OF_MEAN|3.214||0.1342|TWO_SIDED|95.0|-11.24|1.528|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||1.528|-11.24|0.1342
73973504|NCT03812614|147489962|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.07|TWO_SIDED|95.0|-0.05|1.14|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Linear mixed model with random intercept and slope was used to compare the change in HbA1c as a function of time (included using restricted cubic splines), the interaction between time and intervention arm, baseline A1c and whether PT-SP live together (stratification variables), baseline insulin use, age, vital hunger, and preferred language.||1.14|-0.05|0.07
73973505|NCT03812614|147489963|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.96|TWO_SIDED|95.0|-0.67|0.64|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Linear mixed model with random intercept and slope was used to compare the change in A1c as a function of time (included using restricted cubic splines), the interaction between time and intervention arm, baseline A1c and whether PT-SP live together (stratification variables), baseline insulin use, age, vital hunger, and preferred language||0.64|-0.67|0.96
74030830|NCT00406315|147615580|SUPERIORITY_OR_OTHER_LEGACY||Mean|15.32|||||TWO_SIDED|95.0|9.97|20.68||||||Global Satisfaction, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||20.68|9.97|
73866787|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.2|||||TWO_SIDED|95.0|3.33|9.07||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.07|3.33|
73866788|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|0.85|6.55||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.55|0.85|
73866789|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.61|||||TWO_SIDED|95.0|0.74|6.47||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.47|0.74|
73866790|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.17|||||TWO_SIDED|95.0|3.29|9.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.04|3.29|
73866791|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|||||TWO_SIDED|95.0|-6.27|-1.09||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.09|-6.27|
73866792|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.51|||||TWO_SIDED|95.0|-5.07|0.05||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-5.07|
73938441|NCT02479412|147409048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.41|STANDARD_ERROR_OF_MEAN|3.19||0.0016|TWO_SIDED|95.0|-16.75|-4.075|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO||-4.075|-16.75|0.0016
73938442|NCT02479412|147409048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.75|STANDARD_ERROR_OF_MEAN|3.236|<|0.0001|TWO_SIDED|95.0|-21.18|-8.319|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO||-8.319|-21.18|<0.0001
73866793|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|||||TWO_SIDED|95.0|-1.88|3.3||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.30|-1.88|
73938443|NCT02479412|147409049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|5.139||0.0084|TWO_SIDED|95.0|-24.06|-3.642|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||-3.642|-24.06|0.0084
73938444|NCT02479412|147409049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.26|STANDARD_ERROR_OF_MEAN|5.088||0.0062|TWO_SIDED|95.0|-24.37|-4.149|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO||-4.149|-24.37|0.0062
73938445|NCT02479412|147409049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|5.137||0.0002|TWO_SIDED|95.0|-30.1|-9.689|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO||-9.689|-30.10|0.0002
73938446|NCT02479412|147409050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03051|STANDARD_ERROR_OF_MEAN|0.05856||0.6036|TWO_SIDED|95.0|-0.08579|0.1468|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.1468|-0.08579|0.6036
73938447|NCT02479412|147409050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01744|STANDARD_ERROR_OF_MEAN|0.05869||0.767|TWO_SIDED|95.0|-0.09912|0.134|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1340|-0.09912|0.7670
74030831|NCT00257192|147615583|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.8|STANDARD_ERROR_OF_MEAN|1.26||0.153|TWO_SIDED|95.0|-4.28|0.67||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|P-value for final analysis is to be adjusted due to planned interim analysis (0.0462).||Sample size for 85% power 2-tailed 0.05 significance level based on expected difference of -5 with average within-group standard deviation=13 was 276 subjects (2 to 1 ratio of enrollment: 184 ziprasidone, 92 placebo). Interim analysis at 60 percent (%) enrollment (ITT population): may stop trial early for efficacy (2-sided p-value less than (\<) 0.0124) or for futility (2-sided p-value greater than (\>) 0.4772; The final analysis is to employ a 2-sided p-value \<0.0462.||0.67|-4.28|0.1530
74030832|NCT00257192|147615584|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.21|STANDARD_ERROR_OF_MEAN|0.14||0.1289|TWO_SIDED|95.0|-0.48|0.06||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Difference from placebo||0.06|-0.48|0.1289
73938448|NCT02479412|147409050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1561|STANDARD_ERROR_OF_MEAN|0.05874||0.0093|TWO_SIDED|95.0|0.03943|0.2728|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.2728|0.03943|0.0093
73938449|NCT02479412|147409051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03467|STANDARD_ERROR_OF_MEAN|0.05377||0.5207|TWO_SIDED|95.0|-0.1415|0.07213|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.07213|-0.1415|0.5207
73938450|NCT02479412|147409051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02821|STANDARD_ERROR_OF_MEAN|0.05336||0.5983|TWO_SIDED|95.0|-0.07778|0.1342|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1342|-0.07778|0.5983
73938451|NCT02479412|147409051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06169|STANDARD_ERROR_OF_MEAN|0.05371||0.2538|TWO_SIDED|95.0|-0.04501|0.1684|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.1684|-0.04501|0.2538
73938452|NCT02479412|147409052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02262|STANDARD_ERROR_OF_MEAN|0.05743||0.6945|TWO_SIDED|95.0|-0.1367|0.09144|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.09144|-0.1367|0.6945
73938453|NCT02479412|147409052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.000314|STANDARD_ERROR_OF_MEAN|0.05755||0.9957|TWO_SIDED|95.0|-0.1146|0.114|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1140|-0.1146|0.9957
73938454|NCT02479412|147409052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06831|STANDARD_ERROR_OF_MEAN|0.05774||0.2398|TWO_SIDED|95.0|-0.04637|0.183|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.1830|-0.04637|0.2398
73938455|NCT02479412|147409053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.34|STANDARD_ERROR_OF_MEAN|5.877||0.0819|TWO_SIDED|95.0|-1.335|22.01|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||22.01|-1.335|0.0819
73938456|NCT02479412|147409053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.253|STANDARD_ERROR_OF_MEAN|5.881||0.3741|TWO_SIDED|95.0|-6.427|16.93|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||16.93|-6.427|0.3741
73938457|NCT02479412|147409053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.52|STANDARD_ERROR_OF_MEAN|5.926||0.0374|TWO_SIDED|95.0|0.7481|24.29|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||24.29|0.7481|0.0374
73938458|NCT02479412|147409054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.73|STANDARD_ERROR_OF_MEAN|5.384||0.0044|TWO_SIDED|95.0|5.039|26.43|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||26.43|5.039|0.0044
73938459|NCT02479412|147409054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.3|STANDARD_ERROR_OF_MEAN|5.419||0.0098|TWO_SIDED|95.0|3.534|25.06|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||25.06|3.534|0.0098
73938460|NCT02479412|147409054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.91|STANDARD_ERROR_OF_MEAN|5.459||0.0004|TWO_SIDED|95.0|9.068|30.75|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||30.75|9.068|0.0004
73938461|NCT02479412|147409055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3435|STANDARD_ERROR_OF_MEAN|0.189||0.0723|TWO_SIDED|95.0|-0.7189|0.03179|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.03179|-0.7189|0.0723
73938462|NCT02479412|147409055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4852|STANDARD_ERROR_OF_MEAN|0.1903||0.0124|TWO_SIDED|95.0|-0.8631|-0.1073|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||-0.1073|-0.8631|0.0124
73938463|NCT02479412|147409055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8026|STANDARD_ERROR_OF_MEAN|0.1914|<|0.0001|TWO_SIDED|95.0|-1.183|-0.4224|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.4224|-1.183|<0.0001
73938464|NCT02479412|147409056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3071|STANDARD_ERROR_OF_MEAN|0.1051||0.0044|TWO_SIDED|95.0|-0.5159|-0.09836|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.09836|-0.5159|0.0044
73938465|NCT02479412|147409056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1824|STANDARD_ERROR_OF_MEAN|0.1059||0.0883|TWO_SIDED|95.0|-0.3927|0.02789|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.02789|-0.3927|0.0883
73938466|NCT02479412|147409056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4301|STANDARD_ERROR_OF_MEAN|0.1055|<|0.0001|TWO_SIDED|95.0|-0.6397|-0.2205|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.2205|-0.6397|<0.0001
73866794|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|||||TWO_SIDED|95.0|-3.23|1.87||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.87|-3.23|
73866795|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.38|||||TWO_SIDED|95.0|-7.26|-1.5||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.50|-7.26|
73866796|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.76|||||TWO_SIDED|95.0|-4.65|1.12||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.12|-4.65|
73938467|NCT02479412|147409057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1651|STANDARD_ERROR_OF_MEAN|0.09139||0.0741|TWO_SIDED|95.0|-0.3466|0.01638|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.01638|-0.3466|0.0741
73938468|NCT02479412|147409057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09079|STANDARD_ERROR_OF_MEAN|0.09204||0.3265|TWO_SIDED|95.0|-0.2736|0.09201|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.09201|-0.2736|0.3265
73938469|NCT02479412|147409057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2532|STANDARD_ERROR_OF_MEAN|0.09176||0.007|TWO_SIDED|95.0|-0.4354|-0.07092|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.07092|-0.4354|0.0070
73938470|NCT02479412|147409058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4185|STANDARD_ERROR_OF_MEAN|0.1626||0.0116|TWO_SIDED|95.0|-0.7414|-0.09563|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.09563|-0.7414|0.0116
73938471|NCT02479412|147409058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1794|STANDARD_ERROR_OF_MEAN|0.1628||0.2732|TWO_SIDED|95.0|-0.5027|0.1438|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1438|-0.5027|0.2732
73938472|NCT02479412|147409058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7661|STANDARD_ERROR_OF_MEAN|0.1636|<|0.0001|TWO_SIDED|95.0|-1.091|-0.4411|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.4411|-1.091|<0.0001
73938473|NCT02479412|147409059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1067|STANDARD_ERROR_OF_MEAN|0.04982||0.0349|TWO_SIDED|95.0|-0.2057|-0.007755|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.007755|-0.2057|0.0349
73866797|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-2.84|2.91||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.91|-2.84|
73938474|NCT02479412|147409059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08205|STANDARD_ERROR_OF_MEAN|0.05015||0.1052|TWO_SIDED|95.0|-0.1817|0.01756|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.01756|-0.1817|0.1052
73938475|NCT02479412|147409059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2027|STANDARD_ERROR_OF_MEAN|0.05044||0.0001|TWO_SIDED|95.0|-0.3028|-0.1025|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.1025|-0.3028|0.0001
73938476|NCT02479412|147409060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.673|STANDARD_ERROR_OF_MEAN|0.2946||0.0247|TWO_SIDED|95.0|0.08779|1.258|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||1.258|0.08779|0.0247
73866798|NCT01393639|147278705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.47|||||TWO_SIDED|95.0|-5.33|0.39||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.39|-5.33|
73866799|NCT02772978|147278807|SUPERIORITY|||||||0.04||||||The threshold for statistical significance was set to p \< 0.05.|Fisher transformation|||The comparison group represents the difference in ICR and the baseline impulsiveness scale, non-planning subscale.||||0.04
73866800|NCT02772978|147278808|SUPERIORITY||||||<|0.05||||||The threshold is set to p \< 0.05, corrected for multiple comparisons.|Fisher transformation|||||||< 0.05
73938477|NCT02479412|147409060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4281|STANDARD_ERROR_OF_MEAN|0.2965||0.1521|TWO_SIDED|95.0|-0.1607|1.017|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||1.017|-0.1607|0.1521
73938478|NCT02479412|147409060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9415|STANDARD_ERROR_OF_MEAN|0.2987||0.0022|TWO_SIDED|95.0|0.3483|1.535|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||1.535|0.3483|0.0022
73938479|NCT02479412|147409064|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|272.2|||<|0.0001|TWO_SIDED|90.0|237.43|312.05|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg||312.05|237.43|<0.0001
73938480|NCT02479412|147409064|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|676.13|||<|0.0001|TWO_SIDED|90.0|580.91|786.95|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg||786.95|580.91|<0.0001
73938481|NCT02479412|147409065|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|337.82|||<|0.0001|TWO_SIDED|90.0|290.8|392.43|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg||392.43|290.80|<0.0001
73938482|NCT02479412|147409065|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|964.62|||<|0.0001|TWO_SIDED|90.0|816.13|1140.13|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg||1140.13|816.13|<0.0001
73938483|NCT03667053|147409097|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test stratified by injection site and age group.||||<0.001
73938484|NCT03667053|147409098|SUPERIORITY|||||||0.0073||||||Assessed at 30 minutes. Note that p-value was 0.0005 at 10 minutes and \<0.0001 at 15 and 20 minutes.|Cochran-Mantel-Haenszel|||The recovery rates of dasiglucagon and placebo were compared at each time point using a Cochran-Mantel-Haenszel test stratified by age group and injection site. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0073
73957871|NCT02263508|147451266|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.77|1.21|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.21|0.77|0.77
73866801|NCT01532869|147278809|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) mean|-2.7||||0.0915|TWO_SIDED|95.0|-5.85|0.45|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.45|-5.85|0.0915
73938485|NCT03667053|147409099|SUPERIORITY||||||<|0.0001||||||The p-value was \<0.0001 at all time points (10, 15, 20 and 30 minutes)|ANOVA|||Change from baseline in plasma glucose at 30, 20, 15, and 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
73938486|NCT00845663|147409171|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|101.33||||||90.0|92.84|110.58|||ANOVA|ANOVA for log-transformed values with treatment as factor has been used as the basis for calculation of estimated value and confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||110.58|92.84|
73938487|NCT00845663|147409172|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125% bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.7||||||90.0|89.06|107.19|||ANOVA|ANOVA for log-transformed values with treatment as factor was taken as the basis for calculation of estimated value and confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||107.19|89.06|
73938488|NCT00845663|147409173|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.54||||||90.0|87.33|108.94|||ANOVA|ANOVA for log-transformed values with treatment as factor was taken as a basis for calculation of estimated value and the confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||108.94|87.33|
73938489|NCT02273141|147409222|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|8.22||||0.038|ONE_SIDED|97.5|-0.5|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate non-inferiority (NI) of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 success rate - SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-0.50|0.038
73938490|NCT02273141|147409223|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|3.2||||0.027|ONE_SIDED|97.5|-5.56|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 success rate - SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-5.56|0.027
73938491|NCT02273141|147409224|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|2.42||||0.154|TWO_SIDED|95.0|-6.35|11.12||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.12|-6.35|0.154
73938492|NCT02273141|147409225|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.27||||0.212|TWO_SIDED|95.0|-5.56|11.91||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.91|-5.56|0.212
73938493|NCT02273141|147409226|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|4.43||||0.064|TWO_SIDED|95.0|-4.36|13.1||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||13.10|-4.36|0.064
73938494|NCT02273141|147409227|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|2.95||||0.278|TWO_SIDED|95.0|-5.96|11.51||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.51|-5.96|0.278
73938495|NCT04313881|147409234|SUPERIORITY||Odds Ratio (OR)|0.876||||0.5218|TWO_SIDED|95.0|0.585|1.312||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel|||||1.312|0.585|0.5218
73938496|NCT04313881|147409235|SUPERIORITY||Hazard Ratio (HR)|1.203||||0.1299|TWO_SIDED|95.0|0.947|1.528||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% confidence interval (CI) were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.528|0.947|0.1299
73938497|NCT04313881|147409237|SUPERIORITY||Odds Ratio (OR)|0.821||||0.2563|TWO_SIDED|95.0|0.584|1.155||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel|||||1.155|0.584|0.2563
73938498|NCT04313881|147409239|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2191|TWO_SIDED|95.0|0.427|1.212||95% CI for transfusion independence rate was based on Clopper-Pearson exact method. 2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors.|Cochran-Mantel-Haenszel|||||1.212|0.427|0.2191
73938499|NCT04313881|147409240|SUPERIORITY||Hazard Ratio (HR)|0.979||||0.8788|TWO_SIDED|95.0|0.746|1.285||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.285|0.746|0.8788
73973506|NCT03812614|147489964|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.55|TWO_SIDED|95.0|-6.4|3.38|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient SBP was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||3.38|-6.40|0.55
73938500|NCT04313881|147409241|SUPERIORITY||Odds Ratio (OR)|0.441||||0.0375|TWO_SIDED|95.0|0.203|0.96||2-sided P-value, odds ratio and its 95% CI were based on unstratified Cochran-Mantel-Haenszel (CMH) method.|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||0.960|0.203|0.0375
73938501|NCT04313881|147409242|SUPERIORITY||Odds Ratio (OR)|0.947||||0.795|TWO_SIDED|95.0|0.629|1.426||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||1.426|0.629|0.7950
73938502|NCT04313881|147409243|SUPERIORITY||Hazard Ratio (HR)|0.837||||0.461|TWO_SIDED|95.0|0.522|1.343||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.343|0.522|0.4610
73938503|NCT04313881|147409244|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.872|TWO_SIDED|95.0|0.802|1.297||2-sided P-value was based on stratified log-rank test, stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.297|0.802|0.8720
73938504|NCT04313881|147409245|SUPERIORITY|2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors|Odds Ratio (OR)|0.605||||0.0048|TWO_SIDED|95.0|0.428|0.857||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||0.857|0.428|0.0048
73938505|NCT01572727|147409249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.82|1.68||||||||1.68|0.82|
73938506|NCT03998618|147409271|SUPERIORITY||partial correlation|0.12||||0.018|TWO_SIDED|95.0|-0.01|0.25||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 234. multiply imputed data were used in analyses.||||0.25|-0.01|.018
73973507|NCT03812614|147489965|SUPERIORITY||Mean Difference (Final Values)|5.74||||0.03|TWO_SIDED|95.0|0.57|10.91|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient SBP was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||10.91|0.57|0.03
74088962|NCT02985879|147731162|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.88|=|0.812|TWO_SIDED|95.0|-1.52|1.93|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||1.93|-1.52|=0.812
73938507|NCT03998618|147409272|SUPERIORITY||partial correlation|0.11||||0.037|TWO_SIDED|95.0|-0.02|0.24||P-value for study group x time interaction. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance = 0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.24|-0.02|.037
73938508|NCT03998618|147409273|SUPERIORITY||partial correlation|0.07||||0.355|TWO_SIDED|95.0|-0.06|0.2||P-value for study group x time interaction. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance = 0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.20|-0.06|.355
73938509|NCT03998618|147409274|SUPERIORITY||partial correlation|0.08||||0.167|TWO_SIDED|95.0|-0.04|0.21||P-value for study group x time interaction for physical quality of life. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.21|-0.04|.167
73938510|NCT03998618|147409274|SUPERIORITY||partial correlation|0.09||||0.105|TWO_SIDED|95.0|-0.03|0.22||P-value for study group x time interaction for social/family quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.22|-0.03|.105
73938511|NCT03998618|147409274|SUPERIORITY||partial correlation|0.09||||0.142|TWO_SIDED|95.0|-0.04|0.22||P-value for study group x time interaction for emotional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.22|-0.04|.142
73938512|NCT03998618|147409274|SUPERIORITY||partial correlation|0.13||||0.006|TWO_SIDED|95.0|0.01|0.26||P-value for study group x time interaction for functional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.26|0.01|.006
73938513|NCT02195986|147409275|EQUIVALENCE|Bioequivalence was established for the primary endpoint if the 90% confidence interval for the difference of responder rates (test - reference) from baseline to Day 8 for the primary endpoint is contained within \[-0.20, 0.20\], using the per-protocol population.|Difference|-0.0062|||||TWO_SIDED|90.0|-0.1209|0.1084||||||The compound hypothesis to test was: H0: PT -PR \< -.20 or PT -PR \> .20 versus HA : -.20 ≤ PT -PR ≤ .20 Where PT = cure rate of test treatment, and PR = cure rate of reference treatment.||0.1084|-0.1209|
73938514|NCT02195986|147409276|SUPERIORITY|Superiority test of test product vs placebo|Difference|0.3766|||<|0.0001|TWO_SIDED|95.0|0.2743|0.479|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.4790|0.2743|<0.0001
73957872|NCT02263508|147451274|OTHER||Odds Ratio (OR)|1.88||||0.012|TWO_SIDED|95.0|1.15|3.07|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||3.07|1.15|0.012
73957873|NCT02263508|147451275|OTHER||Hazard Ratio (HR)|1.05||||0.14|TWO_SIDED|95.0|0.82|1.34|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.34|0.82|0.14
73957874|NCT02263508|147451276|OTHER||Hazard Ratio (HR)|0.88||||0.47|TWO_SIDED|95.0|0.63|1.24|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.24|0.63|0.47
73957875|NCT02263508|147451277|OTHER||Odds Ratio (OR)|1.32||||0.081|TWO_SIDED|95.0|0.97|1.79|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.79|0.97|0.081
73957876|NCT02263508|147451279|OTHER||Odds Ratio (OR)|1.39||||0.039|TWO_SIDED|95.0|1.02|1.9|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.90|1.02|0.039
73957877|NCT02263508|147451281|OTHER||Odds Ratio (OR)|1.28||||0.11|TWO_SIDED|95.0|0.94|1.75|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.75|0.94|0.11
73957878|NCT02263508|147451282|OTHER||Odds Ratio (OR)|1.44||||0.02|TWO_SIDED|95.0|1.06|1.96|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.96|1.06|0.020
73973508|NCT03812614|147489966|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.76|TWO_SIDED|95.0|-2.15|1.58|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient diabetes distress was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.58|-2.15|0.76
73973509|NCT03812614|147489967|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.72|TWO_SIDED|95.0|-2.11|1.46|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient diabetes distress was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.46|-2.11|0.72
73973510|NCT03812614|147489968|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.38|TWO_SIDED|95.0|-0.76|0.29|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient health eating was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.29|-0.76|0.38
73973511|NCT03812614|147489969|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.7|TWO_SIDED|95.0|-1.11|0.74|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient physical activity was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.74|-1.11|0.70
73973512|NCT03812614|147489970|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.75|TWO_SIDED|95.0|-0.53|0.74|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient diabetes medication adherence was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.74|-0.53|0.75
73973513|NCT03812614|147489970|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.94|TWO_SIDED|95.0|-0.98|0.91|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.91|-0.98|0.94
73973514|NCT03812614|147489970|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.42|TWO_SIDED|95.0|-1.46|0.61|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.61|-1.46|0.42
73973515|NCT03812614|147489971|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.96|TWO_SIDED|95.0|-0.54|0.52|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient self-efficacy was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.52|-0.54|0.96
73973516|NCT03812614|147489972|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.4|TWO_SIDED|95.0|-3.92|9.78|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient activation was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||9.78|-3.92|0.40
73973517|NCT03812614|147489973|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.11|TWO_SIDED|95.0|-0.18|1.68|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient satisfaction with SP support was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.68|-0.18|0.11
73973518|NCT03812614|147489974|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.34|TWO_SIDED|95.0|-0.19|0.55|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient perception of supportive and non-supportive behaviors was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.55|-0.19|0.34
74008393|NCT03627767|147566507|SUPERIORITY||LSM difference|-2.9|||||TWO_SIDED|95.0|-4.2|-1.6||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.6|-4.2|
74008394|NCT03627767|147566507|SUPERIORITY||LSM difference|-2.4|||=|0.0313|TWO_SIDED|95.0|-4.5|-0.2|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-4.5|= 0.0313
74008395|NCT03627767|147566507|SUPERIORITY||LSM difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.1|-3.0|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.0|-7.1|< 0.0001
74008396|NCT03627767|147566507|SUPERIORITY||LSM difference|-2.7|||||TWO_SIDED|95.0|-4.1|-1.3||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.3|-4.1|
74008397|NCT03627767|147566508|SUPERIORITY||LSM difference|-0.1|||=|0.4832|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.4|= 0.4832
74008398|NCT03627767|147566508|SUPERIORITY||LSM difference|-0.1|||=|0.6553|TWO_SIDED|95.0|-0.3|0.2|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.3|= 0.6553
74008399|NCT03627767|147566508|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.2|0.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.2|
73938515|NCT02195986|147409276|SUPERIORITY|Superiority test of reference product vs placebo|Difference|0.3542|||<|0.0001|TWO_SIDED|95.0|0.257|0.4514|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.4514|0.2570|<0.0001
73938516|NCT02195986|147409277|EQUIVALENCE|Bioequivalence was established for the secondary endpoint if the 90% confidence interval for the difference of responder rates (test - reference) from baseline to Day 8 for the secondary endpoint is contained within \[-0.20, 0.20\], using the per-protocol population.|Difference|0.05|||||TWO_SIDED|90.0|-0.0687|0.1686||||||||0.1686|-0.0687|
74030833|NCT00257192|147615585|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-2.57|STANDARD_ERROR_OF_MEAN|2.0||0.1987||95.0|-6.5|1.36||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Total score: difference from placebo||1.36|-6.50|0.1987
74030834|NCT00257192|147615586|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.33|STANDARD_ERROR_OF_MEAN|0.65||0.0412|TWO_SIDED|95.0|-2.61|-0.05||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Positive score: difference from placebo||-0.05|-2.61|0.0412
74030835|NCT00257192|147615586|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.43|STANDARD_ERROR_OF_MEAN|0.58||0.4661|TWO_SIDED|95.0|-1.57|0.72||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Negative score: difference from placebo||0.72|-1.57|0.4661
74030836|NCT00257192|147615587|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.182|TWO_SIDED|95.0|-0.47|0.09||Mixed effects MMRM with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects.|ANOVA|||Difference from placebo||0.09|-0.47|0.1820
74030837|NCT00257192|147615595|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|1.34|STANDARD_ERROR_OF_MEAN|1.19||0.2613|TWO_SIDED|95.0|-1.01|3.69||SAS PROC MIXED to fit a mixed model analysis of covariance with treatment and region as fixed effects and baseline score as covariate.|ANCOVA|Observed cases at Week 6.||Neurocognitive Index score at Week 6: difference from placebo||3.69|-1.01|0.2613
74030838|NCT00570739|147615602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0123|TWO_SIDED|95.0|-0.27|-0.03||P-Value is for the LS mean difference between treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks||-0.03|-0.27|0.0123
74030839|NCT00570739|147615602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.0201|TWO_SIDED|95.0|-0.33|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-0.03|-0.33|0.0201
74030840|NCT00570739|147615602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0239|TWO_SIDED|95.0|-0.36|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||-0.03|-0.36|0.0239
74030841|NCT00570739|147615602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0046|TWO_SIDED|95.0|-0.42|-0.08||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||-0.08|-0.42|0.0046
74030842|NCT00570739|147615603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.1112|TWO_SIDED|95.0|-11.3|1.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 Weeks||1.2|-11.3|0.1112
74030843|NCT00570739|147615603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.2167|TWO_SIDED|95.0|-8.6|2.0|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||2.0|-8.6|0.2167
74030844|NCT00570739|147615603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.7269|TWO_SIDED|95.0|-7.0|4.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||4.9|-7.0|0.7269
74030845|NCT00570739|147615603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.4063|TWO_SIDED|95.0|-8.4|3.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||3.4|-8.4|0.4063
74030846|NCT00570739|147615603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.4909|TWO_SIDED|95.0|-8.0|3.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||3.9|-8.0|0.4909
74030847|NCT00570739|147615604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.303||||0.7606|TWO_SIDED|95.0|-2.259|1.653||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks||1.653|-2.259|0.7606
74030848|NCT00570739|147615604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.015||||0.1782|TWO_SIDED|95.0|-2.477|0.447||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks||0.447|-2.477|0.1782
74030849|NCT00570739|147615604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.504||||0.0332|TWO_SIDED|95.0|-2.887|-0.121||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||-0.121|-2.887|0.0332
74030850|NCT00570739|147615604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176||||0.861|TWO_SIDED|95.0|-1.805|2.158||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||2.158|-1.805|0.8610
73866802|NCT01532869|147278811|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.43||||0.9336|TWO_SIDED|95.0|-10.78|9.91|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.91|-10.78|0.9336
73866803|NCT01532869|147278811|SUPERIORITY_OR_OTHER||Difference in LS mean|-4.12||||0.4609|TWO_SIDED|95.0|-15.21|6.96|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||6.96|-15.21|0.4609
73866804|NCT01532869|147278811|SUPERIORITY_OR_OTHER||Difference in LS mean|-1.28||||0.8493|TWO_SIDED|95.0|-14.7|12.13|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||12.13|-14.70|0.8493
73866805|NCT01532869|147278811|SUPERIORITY_OR_OTHER||Difference in LS mean|4.89||||0.4717|TWO_SIDED|95.0|-8.59|18.37|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||18.37|-8.59|0.4717
73866806|NCT01532869|147278811|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.08||||0.9876|TWO_SIDED|95.0|-9.93|9.78|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.78|-9.93|0.9876
73866807|NCT01532869|147278811|SUPERIORITY_OR_OTHER||Difference in LS mean|-6.8||||0.2407|TWO_SIDED|95.0|-18.3|4.71|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||4.71|-18.30|0.2407
73938517|NCT02195986|147409278|SUPERIORITY|Superiority test of test product vs placebo|Difference|0.1387||||0.1092|TWO_SIDED|95.0|-0.028|0.3054|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.3054|-0.0280|0.1092
73938518|NCT02195986|147409278|SUPERIORITY|Superiority test of reference product vs placebo|Difference|0.1196||||0.1805|TWO_SIDED|95.0|-0.0491|0.2883|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.2883|-0.0491|0.1805
74088963|NCT02985879|147731162|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.88|=|0.104|TWO_SIDED|95.0|-0.3|3.16|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||3.16|-0.30|=0.104
73866808|NCT01532869|147278811|SUPERIORITY_OR_OTHER||Difference in LS mean|1.54||||0.7742|TWO_SIDED|95.0|-9.18|12.26|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||12.26|-9.18|0.7742
73938519|NCT02081846|147409309|SUPERIORITY|||||||0.047|||||||Regression, Logistic|||||||0.047
73938520|NCT02081846|147409310|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
73866809|NCT01532869|147278811|SUPERIORITY_OR_OTHER||Difference in LS mean|-4.48||||0.5182|TWO_SIDED|95.0|-18.28|9.31|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.31|-18.28|0.5182
73866810|NCT01532869|147278811|SUPERIORITY_OR_OTHER||Difference in LS mean|-5.8||||0.3106|TWO_SIDED|95.0|-17.2|5.59|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.59|-17.20|0.3106
73866811|NCT01532869|147278811|SUPERIORITY_OR_OTHER||Difference in LS mean|-7.82||||0.1717|TWO_SIDED|95.0|-19.11|3.48|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||3.48|-19.11|0.1717
73938521|NCT02081846|147409311|SUPERIORITY|||||||0.82|||||||censored Poisson model|||||||0.82
73938522|NCT02081846|147409312|SUPERIORITY||||||<|0.01|||||||Poisson model|||||||<0.01
73938523|NCT02081846|147409313|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
73938524|NCT02081846|147409314|SUPERIORITY|||||||0.052|||||||Regression, Logistic|||||||0.052
73866812|NCT01532869|147278812|SUPERIORITY_OR_OTHER||Difference in LS mean|0.02||||0.8503|TWO_SIDED|95.0|-0.186|0.225|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction||0.225|-0.186|0.8503
73866813|NCT01532869|147278812|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.207||||0.1212|TWO_SIDED|95.0|-0.471|0.056|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.056|-0.471|0.1212
73866814|NCT01532869|147278813|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.99||||0.8118|TWO_SIDED|95.0|-9.2|7.23|||Mixed Models Analysis|||Change From Baseline in Clinician's Global Assessment at Week 24.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||7.23|-9.20|0.8118
73866815|NCT01532869|147278813|SUPERIORITY_OR_OTHER||Difference in LS mean|-9.02||||0.0768|TWO_SIDED|95.0|-19.04|1.0|||Mixed Models Analysis|||Change From Baseline in Clinician's Global Assessment at Week 48.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||1.00|-19.04|0.0768
73866816|NCT01532869|147278814|SUPERIORITY_OR_OTHER||Difference in LS mean|-3.85||||0.4063|TWO_SIDED|95.0|-13.04|5.34|||Mixed Models Analysis|||Change From Baseline in Patient's Global Assessment at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.34|-13.04|0.4063
73938525|NCT02081846|147409315|SUPERIORITY|||||||0.12|||||||Regression, Logistic|||||||0.12
73938526|NCT02693665|147409515|SUPERIORITY|First measure of congruence was taken at 2 weeks post-baseline for controls, or immediately post-Session 2 for intervention dyads. Analysis presented here assessed differences between groups in agreement. This represents the underlying data without examining the pattern of congruence for each dyad over time. Longitudinal latent class analysis of congruence in responses over time between adolescents/families was conducted at the person not variable level.|Odds Ratio (OR)|3.22|||<|0.05|TWO_SIDED|95.0|1.09|9.57|||longitudinal latent class analysis|examined the pattern of change over time.||"Analysis was at the level of the dyad. AIM 1. To evaluate the efficacy of FACE-TC on patient-family congruence in treatment preferences.~H1a: FACE-TC participants will better maintain congruence over time, compared to controls.~H1b: Development of congruence may not be homogeneous and FACE-TC may influence the pattern of congruence development."||9.57|1.09|<0.05
73938527|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|1.00743162|||<|0.05|TWO_SIDED|95.0|0.928|1.094||The generalized mixed effect models are taking into account missingness by attrition. There were not missing values for the outcomes or predictors that we used.|Mixed Models Analysis|Model forced age, gender, race, family education, family income under the Federal Poverty level, on/off treatment.||Emotional distress-anxiety analysis at baseline comparing intervention and control.||1.094|0.928|<0.05
73938528|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|1.05037501|||<|0.05|TWO_SIDED|95.0|0.96438584|1.14403138||The generalized mixed effect models are taking into account missingness by attrition. There were not missing values for the outcomes or predictors that we used.|Mixed Models Analysis|Model forced age, gender, race, family education, family income under the Federal Poverty level, on/off treatment.||Emotional distress-anxiety analysis at 3 months post baseline comparing intervention and control. We hypothesized that anxiety would be lower in the intervention group compared to controls.||1.14403138|0.96438584|<0.05
73938529|NCT02693665|147409516|SUPERIORITY|See earlier comments.|Risk Ratio (RR)|1.01136067|||<|0.05|TWO_SIDED|95.0|0.92887892|1.10116656||See earlier comments.|t-test, 2 sided|See earlier comments.||This is analysis for 6 month outcomes of Emotional-distress - anxiety. See details in 3 month outcomes.||1.10116656|0.92887892|<0.05
73938530|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|1.14070431|||<|0.05|TWO_SIDED|95.0|1.04444724|1.2458325|||t-test, 2 sided||See earlier comments.|These are the 12 month outcomes for Emotional distress - anxiety. See earlier comments.||1.24583250|1.04444724|<0.05
73938531|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|0.98078271|||<|0.05|TWO_SIDED|95.0|0.89845609|1.07065301|||t-test, 2 sided|||This analysis is for the outcome Emotional distress - depressive symptoms. We hypothesized that adolescent in the intervention would have lower depressive symptoms compared to controls at 3, 6, and 12 month outcomes. The following are the baseline comparisons between control and intervention which were controlled for in the 3, 6, and 12 month analysis of outcomes.||1.07065301|0.89845609|<0.05
73973519|NCT03812614|147489976|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.47|TWO_SIDED|95.0|-2.67|1.23|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||1.23|-2.67|0.47
73866817|NCT01532869|147278814|SUPERIORITY_OR_OTHER||Difference in LS mean|-8.3||||0.1371|TWO_SIDED|95.0|-19.31|2.71|||Mixed Models Analysis|||Change From Baseline in Patient's Global Assessment at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||2.71|-19.31|0.1371
74008400|NCT03627767|147566508|SUPERIORITY||LSM difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.1|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.1|-1.5|< 0.0001
74030851|NCT00570739|147615604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.8196|TWO_SIDED|95.0|-1.599|2.019||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||2.019|-1.599|0.8196
74030852|NCT00570739|147615605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153||||0.1078|TWO_SIDED|95.0|-0.34|0.034||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks||0.034|-0.340|0.1078
74030853|NCT00570739|147615605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141||||0.1146|TWO_SIDED|95.0|-0.317|0.035||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||0.035|-0.317|0.1146
74030854|NCT00570739|147615606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9933|TWO_SIDED|95.0|-9.3|9.4||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks||9.4|-9.3|0.9933
74030855|NCT00570739|147615606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.8203|TWO_SIDED|95.0|-10.5|8.3||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks LOCF||8.3|-10.5|0.8203
74030856|NCT00570739|147615607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0||||0.195|TWO_SIDED|95.0|-17.5|3.6||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||3.6|-17.5|0.1950
74030857|NCT00570739|147615607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.1583|TWO_SIDED|95.0|-18.3|3.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||3.0|-18.3|0.1583
74030858|NCT00570739|147615608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.3663|TWO_SIDED|95.0|-16.1|6.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||6.0|-16.1|0.3663
74030859|NCT00570739|147615608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.2524|TWO_SIDED|95.0|-17.9|4.7||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||4.7|-17.9|0.2524
74030860|NCT00570739|147615609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.051||||0.8158|TWO_SIDED|95.0|-7.828|9.929||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||9.929|-7.828|0.8158
74030861|NCT00570739|147615609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.565||||0.7433|TWO_SIDED|95.0|-10.966|7.836||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.836|-10.966|0.7433
74030862|NCT00570739|147615610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215||||0.5161|TWO_SIDED|95.0|-0.437|0.867||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||0.867|-0.437|0.5161
74030863|NCT00570739|147615610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.8319|TWO_SIDED|95.0|-0.581|0.722||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||0.722|-0.581|0.8319
74030864|NCT00570739|147615611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.19|||<|0.0001|TWO_SIDED|95.0|-22.61|-13.76|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-13.76|-22.61|<0.0001
74030865|NCT00570739|147615611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.08|||<|0.0001|TWO_SIDED|95.0|-22.09|-12.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-12.08|-22.09|<0.0001
74030866|NCT00570739|147615611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.33|||<|0.0001|TWO_SIDED|95.0|-20.96|-11.69|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-11.69|-20.96|<0.0001
74030867|NCT00570739|147615612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-15.99|-8.81|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-8.81|-15.99|<0.0001
74030868|NCT00570739|147615612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.28|||<|0.0001|TWO_SIDED|95.0|-13.23|-5.34|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-5.34|-13.23|<0.0001
74030869|NCT00570739|147615612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33|||<|0.0001|TWO_SIDED|95.0|-11.98|-4.67|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Week LOCF||-4.67|-11.98|<0.0001
74030870|NCT00570739|147615613|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.63||||0.2026|TWO_SIDED|95.0|-1.43|6.7|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||6.70|-1.43|0.2026
74030871|NCT00570739|147615613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.4506|TWO_SIDED|95.0|-2.12|4.75|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||4.75|-2.12|0.4506
74030872|NCT00570739|147615613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.2609|TWO_SIDED|95.0|-1.35|4.97|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||4.97|-1.35|0.2609
74030873|NCT00570739|147615614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.81|||<|0.0001|TWO_SIDED|95.0|-11.53|-6.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-6.08|-11.53|<0.0001
73938532|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|1.04007715|||<|0.05|TWO_SIDED|95.0|0.94970156|1.13905306|||t-test, 2 sided|||The results here are for the outcome variable Emotional Distress - Depressive symptoms at 3 month outcomes. We hypothesized that adolescents randomized to the intervention would have lower depressive symptoms than controls.||1.13905306|0.94970156|<0.05
73938533|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|1.07347088|||<|0.05|TWO_SIDED|95.0|0.9806271|1.17510491|||t-test, 2 sided|||We hypothesize that Emotional Distress - Depressive symptoms would be lower in intervention adolescents compared to controls at 6 months post intervention.||1.17510491|0.98062710|<0.05
73938534|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|1.11582434|||<|0.05|TWO_SIDED|95.0|1.01653156|1.22481585|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would have lower scores on Emotional Distress - Depressive symptoms compared to controls at 12 months post baseline.||1.22481585|1.01653156|<0.05
73938535|NCT02693665|147409516|SUPERIORITY||Risk Ratio, log|0.98803061|||<|0.05|TWO_SIDED|95.0|0.89065531|1.09605195|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would have no differences in fatigue at baseline if randomization was successful. In this analysis we examine the baseline results.||1.09605195|0.89065531|<0.05
73938536|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|1.13509797|||<|0.05|TWO_SIDED|95.0|1.01959639|1.26368376|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention arm would report less Fatigue at 3 months outcome compared to controls.||1.26368376|1.01959639|<0.05
73938537|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|1.04944737|||<|0.05|TWO_SIDED|95.0|0.94281417|1.16814089|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would report less Fatigue at 6 months post baseline compared to control adolescents.||1.16814089|0.94281417|<0.05
73938538|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|1.11042568|||<|0.05|TWO_SIDED|95.0|0.99383841|1.24068981|||t-test, 2 sided|||We hypothesized that intervention adolescents would report less Fatigue than controls at 12 months post baseline.||1.24068981|0.99383841|<0.05
74088964|NCT02985879|147731163|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16|=|0.756|TWO_SIDED|95.0|-0.36|0.26|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.26|-0.36|=0.756
74088965|NCT02985879|147731163|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.16|=|0.409|TWO_SIDED|95.0|-0.44|0.18|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.18|-0.44|=0.409
73866818|NCT01532869|147278815|SUPERIORITY_OR_OTHER||Difference in LS mean|1.43||||0.5197|TWO_SIDED|95.0|-2.97|5.82|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.82|-2.97|0.5197
73866819|NCT01532869|147278815|SUPERIORITY_OR_OTHER||Difference in LS mean|2.75||||0.1886|TWO_SIDED|95.0|-1.38|6.88|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||6.88|-1.38|0.1886
73938539|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|0.9683347|||<|0.05|TWO_SIDED|95.0|0.88658183|1.05762611|||t-test, 2 sided|||We hypothesized that there would be no differences at baseline between intervention and control adolescents with respect to Pain Interference.||1.05762611|0.88658183|<0.05
73938540|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|1.04450374|||<|0.05|TWO_SIDED|95.0|0.95307464|1.1447037|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 3 months post baseline.||1.14470370|0.95307464|<0.05
73938541|NCT02693665|147409516|SUPERIORITY||Risk Ratio (RR)|1.07182133|||<|0.05|TWO_SIDED|95.0|0.97835451|1.17421748|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 6 months post baseline.||1.17421748|0.97835451|<0.05
73938542|NCT02693665|147409516|SUPERIORITY||Risk Ratio, log|1.09964781|||<|0.05|TWO_SIDED|95.0|1.00051223|1.20860622|||t-test, 2 sided|||We hypothesized that at 12 month outcome adolescents randomized to the intervention would report less Pain Interference compared to control adolescents.||1.20860622|1.00051223|<0.05
73938543|NCT02693665|147409517|SUPERIORITY||Mean ratio|0.98|||<|0.05|TWO_SIDED|95.0|0.88|1.09|||Mixed Models Analysis|||Meaning and Peace Subscale at 3 months post intervention||1.09|0.88|<0.05
73938544|NCT02693665|147409517|SUPERIORITY||Mean ratio|0.97|||<|0.05|TWO_SIDED|95.0|0.88|1.08|||Mixed Models Analysis|||Meaning and Peace subscale at 6 months post intervention||1.08|0.88|<0.05
73938545|NCT02693665|147409517|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.82|1.02|||Mixed Models Analysis|||Meaning and Peace subscale at 12 months post intervention||1.02|0.82|<0.05
73938546|NCT02693665|147409517|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.73|1.16|||Mixed Models Analysis|||Faith subscale score at 3 months post intervention||1.16|0.73|<0.05
73938547|NCT02693665|147409517|SUPERIORITY||Mean ratio|0.96|||<|0.05|TWO_SIDED|95.0|0.76|1.21|||Mixed Models Analysis|||Faith subscale at 6 months post intervention||1.21|0.76|<0.05
73938548|NCT02693665|147409517|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.72|1.17|||Mixed Models Analysis|||Faith subscale scores at 12 months post intervention||1.17|0.72|<0.05
73973520|NCT03812614|147489977|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.35|TWO_SIDED|95.0|-0.78|0.27|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||0.27|-0.78|0.35
73938549|NCT02693665|147409518|SUPERIORITY||Mean Difference (Final Values)|-0.14|||<|0.05|TWO_SIDED|95.0|-0.42|0.15|||GEE model|||Caregiver Strain subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.15|-0.42|<0.05
73938550|NCT02693665|147409518|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED|95.0|0.02|0.36|||GEE model|||Positive Caregiving Appraisal subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.36|0.02|<0.05
73938551|NCT02693665|147409518|SUPERIORITY||Mean Difference (Final Values)|-0.01|||<|0.05|TWO_SIDED|95.0|-0.35|0.32|||GEE model|||Caregiver Distress subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.32|-0.35|<0.05
73938552|NCT02693665|147409518|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.05|TWO_SIDED|95.0|-0.07|0.38|||GEE model|||Family Well-Being subscale at 3 months post-intervention, comparing intervention to TAU, controlling for baseline levels.||0.38|-0.07|<0.05
73938553|NCT02693665|147409520|SUPERIORITY||Slope|0.44|STANDARD_ERROR_OF_MEAN|0.59||0.47|TWO_SIDED||||||Regression, Linear|Intervention effect for quality of adolescent communication score controlling for age, gender, race, income and on active treatment.|It is the standard error of the slope, but this was not an option.|Quality of communication analysis for adolescents||||0.47
73938554|NCT02693665|147409520|SUPERIORITY||Slope|1.15|STANDARD_ERROR_OF_MEAN|0.41|<|0.01|TWO_SIDED||||||Regression, Linear|Testing intervention effect for family member quality of communication score controlling for age, gender, race, income nd on active treatment.|This is standard error of the slope.|Quality of communication analysis for family member.||||<0.01
73938555|NCT02693665|147409526|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|0.71|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Adolescent positive score comparing intervention with TAU.||||<0.05
73938556|NCT02693665|147409526|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Adolescent negative worded score comparing intervention to TAU.||||<0.05
73938557|NCT02693665|147409526|SUPERIORITY||Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|0.74|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Family member positively worded score comparing intervention with treatment as usual.||||<0.05
74030874|NCT00570739|147615614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.94|||<|0.0001|TWO_SIDED|95.0|-10.23|-3.66|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-3.66|-10.23|<0.0001
73866820|NCT01532869|147278816|SUPERIORITY_OR_OTHER||Difference in LS mean|0.79||||0.3651|TWO_SIDED|95.0|-0.94|2.51|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||2.51|-0.94|0.3651
73938558|NCT02693665|147409526|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.81|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Family member negative worded score comparing intervention to TAU.||||<0.05
73938559|NCT00710424|147409529|SUPERIORITY_OR_OTHER_LEGACY||estimated treatment effect|-0.12||||0.634|TWO_SIDED|95.0|-0.6|0.36|||ANCOVA||A negative difference in treatment effect indicates an improvement in pain in favour of Sativex.|The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.||0.36|-0.60|0.634
73938560|NCT00710424|147409530|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.37|STANDARD_ERROR_OF_MEAN|2.153||0.865|TWO_SIDED|95.0|-3.87|4.61|||ANCOVA|||The change from baseline in mean neuropathic pain scale scale score at the end of treatment was to be compared between treatment groups using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||4.61|-3.87|0.865
73938561|NCT00710424|147409531|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.45||||0.139|TWO_SIDED|95.0|-1.04|0.15|||ANCOVA|||The change from baseline in mean sleep quality numerical rating scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.||0.15|-1.04|0.139
73938562|NCT00710424|147409532|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.301||||0.219|TWO_SIDED|95.0|0.855|1.981|||Regression, Logistic|||In the analysis of Subject Global Impression of Change, the two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated centre group as a factor.||1.981|0.855|0.219
73973521|NCT03812614|147489978|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.06|TWO_SIDED|95.0|-1.0|0.01|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient healthy eating was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.01|-1.00|0.06
74030875|NCT00570739|147615614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.09||||0.0001|TWO_SIDED|95.0|-9.14|-3.05|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-3.05|-9.14|0.0001
74030876|NCT00570739|147615615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05||||0.0171|TWO_SIDED|95.0|-0.33|13.99||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 8 weeks||13.99|-0.33|0.0171
74030877|NCT00570739|147615615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.71|||<|0.0001|TWO_SIDED|95.0|9.66|25.54||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks||25.54|9.66|<0.0001
73938563|NCT00710424|147409533|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.05||||0.841|TWO_SIDED|95.0|-0.51|0.42|||ANCOVA|||The change from baseline in mean brief pain inventory (short form) composite score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.||0.42|-0.51|0.841
73938564|NCT00710424|147409534|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.523|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|||The change from baseline in weighted health state index score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline symptom score as a covariate.||0.03|-0.06|0.523
73938565|NCT00710424|147409535|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.17||||0.41|TWO_SIDED|95.0|-0.59|0.24|||ANCOVA|||The model used for the analysis of the end of study value was ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments. A negative difference in adjusted means indicates an improvement in favour of Sativex.||0.24|-0.59|0.410
73938566|NCT00710424|147409538|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.857||||0.521|TWO_SIDED|95.0|0.537|1.37|||Regression, Logistic|||The numbers of responders were to be analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio.||1.370|0.537|0.521
73938567|NCT01962493|147409539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.155||0.1313|TWO_SIDED|95.0|-0.51|0.1||Analysis based on square root transformation. Results back transformed for interpretation.|ANCOVA|Results were obtained from ANCOVA model with Site, Treatment, Treatment X Site, Smoking Status as fixed effects and baseline MLSI as a covariate.|Difference is first named treatment minus second named treatment. A negative difference favors the first named treatment|Null hypothesis stated that there was no difference between treatment groups||0.10|-0.51|0.1313
73938568|NCT02621931|147409558|SUPERIORITY||LSM difference from placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.46|-1.15||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the statistical analysis plan (SAP).||-1.15|-2.46|<0.0001
73938569|NCT02621931|147409558|SUPERIORITY||LSM difference from placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.76|-1.45||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||-1.45|-2.76|<0.0001
73938570|NCT02621931|147409560|SUPERIORITY||LSM difference from placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-2.48|-0.97||0.05 level of significance|ANCOVA|||||-0.97|-2.48|<0.0001
73938571|NCT02621931|147409560|SUPERIORITY||LSM difference from placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-2.61|-1.09||0.05 level of significance|ANCOVA|||||-1.09|-2.61|<0.0001
74030878|NCT00570739|147615615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.62|||<|0.0001|TWO_SIDED|95.0|11.18|25.74||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks LOCF||25.74|11.18|<0.0001
73938572|NCT02621931|147409561|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/placebo/placebo to Placebo||||<0.0001
73938573|NCT02621931|147409561|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/225/225 to Placebo||||<0.0001
73938574|NCT02621931|147409561|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2||||<0.0001
73938575|NCT02621931|147409561|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2||||<0.0001
73938576|NCT02621931|147409561|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3||||<0.0001
73938577|NCT02621931|147409561|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3||||<0.0001
73938578|NCT02621931|147409561|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall||||<0.0001
73938579|NCT02621931|147409561|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall||||<0.0001
73938580|NCT02621931|147409562|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
73938581|NCT02621931|147409562|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
73938582|NCT02621931|147409563|SUPERIORITY||LSM difference from placebo|-2.3|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.95|-1.73||0.05 level of significance|ANCOVA|||||-1.73|-2.95|<0.0001
73938583|NCT02621931|147409564|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
73938584|NCT02621931|147409564|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
73938585|NCT02621931|147409565|SUPERIORITY|||||||0.0004||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||0.0004
73938586|NCT02621931|147409565|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
73938587|NCT03248739|147409578|EQUIVALENCE|Based on occlusion data from the previously referenced prospective study, as well as a P-value of 0.05 and power of 0.80, the study will need to include 90 patients to demonstrate statistical significance. To ensure that power is adequate, we will plan to enroll 120 patients (60 in each arm).||||||0.23|||||||Fisher Exact|||||||0.23
73938588|NCT00515502|147409599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-3.0|2.2|||Mixed Models Analysis|||||2.2|-3.0|
73938589|NCT00515502|147409599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|-2.1|2.9|||Mixed Models Analysis|||||2.9|-2.1|
73938590|NCT00515502|147409599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|95.0|-1.4|5.7|||Mixed Models Analysis|||||5.7|-1.4|
73938591|NCT00515502|147409599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|-6.2|0.9|||Mixed Models Analysis|||||0.9|-6.2|
73938592|NCT00515502|147409599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.78|||TWO_SIDED|95.0|-1.3|5.8|||Mixed Models Analysis|||||5.8|-1.3|
73938593|NCT00515502|147409599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.89|||TWO_SIDED|95.0|-0.7|6.9|||Mixed Models Analysis|||||6.9|-0.7|
73938594|NCT00515502|147409599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-0.1|9.7|||Mixed Models Analysis|||||9.7|-0.1|
73938595|NCT00515502|147409600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.844|||TWO_SIDED|95.0|-2.47|0.92|||Mixed Models Analysis|||||0.92|-2.47|
74030879|NCT00570739|147615616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81||||0.0496|TWO_SIDED|95.0|0.0|5.62|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks||5.62|0.0|0.0496
73938596|NCT00515502|147409600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.798|||TWO_SIDED|95.0|-0.57|2.64|||Mixed Models Analysis|||||2.64|-0.57|
73938597|NCT00515502|147409600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_ERROR_OF_MEAN|1.151|||TWO_SIDED|95.0|-0.35|4.26|||Mixed Models Analysis|||||4.26|-0.35|
73938598|NCT00515502|147409600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|1.193|||TWO_SIDED|95.0|-4.11|0.67|||Mixed Models Analysis|||||0.67|-4.11|
73938599|NCT00515502|147409600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-1.44|3.33|||Mixed Models Analysis|||||3.33|-1.44|
73938600|NCT00515502|147409600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|1.257|||TWO_SIDED|95.0|0.24|5.28|||Mixed Models Analysis|||||5.28|0.24|
73938601|NCT00515502|147409600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|0.34|7.02|||Mixed Models Analysis|||||7.02|0.34|
73938602|NCT00515502|147409601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|95.0|-5.0|3.4|||Mixed Models Analysis|||||3.4|-5.0|
73938603|NCT00515502|147409601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-7.6|0.6|||Mixed Models Analysis|||||0.6|-7.6|
73938604|NCT00515502|147409601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-2.2|8.7|||Mixed Models Analysis|||||8.7|-2.2|
73938605|NCT00515502|147409601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-4.7|7.2|||Mixed Models Analysis|||||7.2|-4.7|
73938606|NCT00515502|147409601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-7.7|3.6|||Mixed Models Analysis|||||3.6|-7.7|
73938607|NCT00515502|147409601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-11.2|1.6|||Mixed Models Analysis|||||1.6|-11.2|
73938608|NCT00515502|147409601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.9|10.0|||Mixed Models Analysis|||||10.0|-5.9|
73938609|NCT00515502|147409602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.902|||TWO_SIDED|95.0|-6.23|1.39|||Mixed Models Analysis|||||1.39|-6.23|
73938610|NCT00515502|147409602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|1.834|||TWO_SIDED|95.0|-5.56|1.79|||Mixed Models Analysis|||||1.79|-5.56|
73938611|NCT00515502|147409602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|2.474|||TWO_SIDED|95.0|-3.82|6.07|||Mixed Models Analysis|||||6.07|-3.82|
73938612|NCT00515502|147409602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|2.697|||TWO_SIDED|95.0|-5.07|5.69|||Mixed Models Analysis|||||5.69|-5.07|
73938613|NCT00515502|147409602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|2.562|||TWO_SIDED|95.0|-7.84|2.38|||Mixed Models Analysis|||||2.38|-7.84|
73938614|NCT00515502|147409602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|2.898|||TWO_SIDED|95.0|-7.97|3.59|||Mixed Models Analysis|||||3.59|-7.97|
73938615|NCT00515502|147409602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|3.618|||TWO_SIDED|95.0|-6.39|8.02|||Mixed Models Analysis|||||8.02|-6.39|
73938616|NCT00515502|147409603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-5.1|0.2|||Mixed Models Analysis|||||0.2|-5.1|
73938617|NCT00515502|147409603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|-4.6|0.4|||Mixed Models Analysis|||||0.4|-4.6|
73938618|NCT00515502|147409603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|0.0|6.6|||Mixed Models Analysis|||||6.6|-0.0|
73938619|NCT00515502|147409603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|95.0|-5.9|1.2|||Mixed Models Analysis|||||1.2|-5.9|
73938620|NCT00515502|147409603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|95.0|-3.5|3.3|||Mixed Models Analysis|||||3.3|-3.5|
73938621|NCT00515502|147409603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-3.5|4.1|||Mixed Models Analysis|||||4.1|-3.5|
73938622|NCT00515502|147409603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|1.0|10.4|||Mixed Models Analysis|||||10.4|1.0|
73938623|NCT00515502|147409604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|95.0|-5.08|-0.87|||Mixed Models Analysis|||||-0.87|-5.08|
73938624|NCT00515502|147409604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.006|||TWO_SIDED|95.0|-3.53|0.5|||Mixed Models Analysis|||||0.50|-3.53|
73938625|NCT00515502|147409604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|1.335|||TWO_SIDED|95.0|-0.46|4.88|||Mixed Models Analysis|||||4.88|-0.46|
73938626|NCT00515502|147409604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32|STANDARD_ERROR_OF_MEAN|1.409|||TWO_SIDED|95.0|-6.13|-0.5|||Mixed Models Analysis|||||-0.50|-6.13|
73938627|NCT00515502|147409604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|1.366|||TWO_SIDED|95.0|-2.38|3.07|||Mixed Models Analysis|||||3.07|-2.38|
73938628|NCT00515502|147409604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.514|||TWO_SIDED|95.0|-1.22|4.82|||Mixed Models Analysis|||||4.82|-1.22|
73938629|NCT00515502|147409604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.53|STANDARD_ERROR_OF_MEAN|1.867|||TWO_SIDED|95.0|1.81|9.25|||Mixed Models Analysis|||||9.25|1.81|
73938630|NCT00515502|147409605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|3.256|||TWO_SIDED|95.0|-9.82|3.21|||Mixed Models Analysis|||||3.21|-9.82|
73938631|NCT00515502|147409605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|3.193|||TWO_SIDED|95.0|-4.7|8.09|||Mixed Models Analysis|||||8.09|-4.70|
73938632|NCT00515502|147409605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|4.268|||TWO_SIDED|95.0|-10.06|6.98|||Mixed Models Analysis|||||6.98|-10.06|
73938633|NCT00515502|147409605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17|STANDARD_ERROR_OF_MEAN|4.347|||TWO_SIDED|95.0|-13.84|3.5|||Mixed Models Analysis|||||3.50|-13.84|
73866821|NCT01532869|147278816|SUPERIORITY_OR_OTHER||Difference in LS mean|-1.11||||0.2841|TWO_SIDED|95.0|-3.16|0.94|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.94|-3.16|0.2841
73938634|NCT00515502|147409605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|4.264|||TWO_SIDED|95.0|-6.65|10.37|||Mixed Models Analysis|||||10.37|-6.65|
73938635|NCT00515502|147409605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|STANDARD_ERROR_OF_MEAN|4.622|||TWO_SIDED|95.0|-2.35|16.08|||Mixed Models Analysis|||||16.08|-2.35|
73938636|NCT00515502|147409605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.63|STANDARD_ERROR_OF_MEAN|5.634|||TWO_SIDED|95.0|-7.59|14.85|||Mixed Models Analysis|||||14.85|-7.59|
73938637|NCT00515502|147409606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.298|STANDARD_ERROR_OF_MEAN|2.3297|||TWO_SIDED|95.0|-4.961|4.365|||Mixed Models Analysis|||||4.365|-4.961|
73938638|NCT00515502|147409606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.066|STANDARD_ERROR_OF_MEAN|2.2776|||TWO_SIDED|95.0|-3.495|5.627|||Mixed Models Analysis|||||5.627|-3.495|
73938639|NCT00515502|147409606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.062|STANDARD_ERROR_OF_MEAN|3.0952|||TWO_SIDED|95.0|-8.247|4.122|||Mixed Models Analysis|||||4.122|-8.247|
73938640|NCT00515502|147409606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.362|STANDARD_ERROR_OF_MEAN|3.1891|||TWO_SIDED|95.0|-6.003|6.726|||Mixed Models Analysis|||||6.726|-6.003|
73938641|NCT00515502|147409606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|3.1121|||TWO_SIDED|95.0|-6.873|5.554|||Mixed Models Analysis|||||5.554|-6.873|
73938642|NCT00515502|147409606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.704|STANDARD_ERROR_OF_MEAN|3.3916|||TWO_SIDED|95.0|-6.064|7.473|||Mixed Models Analysis|||||7.473|-6.064|
73938643|NCT00515502|147409606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.424|STANDARD_ERROR_OF_MEAN|4.2233|||TWO_SIDED|95.0|-10.84|5.993|||Mixed Models Analysis|||||5.993|-10.84|
73938644|NCT00515502|147409607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|2.542|||TWO_SIDED|95.0|-4.98|5.15|||Mixed Models Analysis|||||5.15|-4.98|
73938645|NCT00515502|147409607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|2.507|||TWO_SIDED|95.0|-3.65|6.34|||Mixed Models Analysis|||||6.34|-3.65|
73938646|NCT00515502|147409607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|3.182|||TWO_SIDED|95.0|-7.49|5.19|||Mixed Models Analysis|||||5.19|-7.49|
73938647|NCT00515502|147409607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|3.296|||TWO_SIDED|95.0|-6.89|6.24|||Mixed Models Analysis|||||6.24|-6.89|
73938648|NCT00515502|147409607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|3.279|||TWO_SIDED|95.0|-6.13|6.94|||Mixed Models Analysis|||||6.94|-6.13|
73938649|NCT00515502|147409607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|3.516|||TWO_SIDED|95.0|-5.34|8.67|||Mixed Models Analysis|||||8.67|-5.34|
73938650|NCT00515502|147409607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|4.087|||TWO_SIDED|95.0|-8.97|7.32|||Mixed Models Analysis|||||7.32|-8.97|
73938651|NCT00515502|147409608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.464|STANDARD_ERROR_OF_MEAN|1.9766|||TWO_SIDED|95.0|-2.492|5.419|||Mixed Models Analysis|||||5.419|-2.492|
73938652|NCT00515502|147409608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|STANDARD_ERROR_OF_MEAN|1.9457|||TWO_SIDED|95.0|-3.647|4.144|||Mixed Models Analysis|||||4.144|-3.647|
73938653|NCT00515502|147409608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.645|STANDARD_ERROR_OF_MEAN|2.5254|||TWO_SIDED|95.0|-7.687|2.396|||Mixed Models Analysis|||||2.396|-7.687|
73938654|NCT00515502|147409608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.585|STANDARD_ERROR_OF_MEAN|2.6352|||TWO_SIDED|95.0|-2.671|7.84|||Mixed Models Analysis|||||7.840|-2.671|
73938655|NCT00515502|147409608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.121|STANDARD_ERROR_OF_MEAN|2.5993|||TWO_SIDED|95.0|-6.308|4.067|||Mixed Models Analysis|||||4.067|-6.308|
73938656|NCT00515502|147409608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.336|STANDARD_ERROR_OF_MEAN|2.8164|||TWO_SIDED|95.0|-7.952|3.28|||Mixed Models Analysis|||||3.280|-7.952|
73938657|NCT00515502|147409608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|3.3802|||TWO_SIDED|95.0|-11.96|1.504|||Mixed Models Analysis|||||1.504|-11.96|
73938658|NCT00515502|147409609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|2.24|||TWO_SIDED|95.0|-9.7|-0.7|||Mixed Models Analysis|||||-0.7|-9.7|
73938659|NCT00515502|147409609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|2.15|||TWO_SIDED|95.0|-8.9|-0.3|||Mixed Models Analysis|||||-0.3|-8.9|
73938660|NCT00515502|147409609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|95.0|-13.5|-1.8|||Mixed Models Analysis|||||-1.8|-13.5|
74030880|NCT00570739|147615616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65||||0.0117|TWO_SIDED|95.0|0.82|6.47|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||6.47|0.82|0.0117
74030881|NCT00570739|147615616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.43||||0.0009|TWO_SIDED|95.0|1.83|7.03|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.03|1.83|0.0009
74030882|NCT00570739|147615617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.56|||<|0.0001|TWO_SIDED|95.0|-14.74|-8.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-8.38|-14.74|<0.0001
73938661|NCT00515502|147409609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|-11.8|1.1|||Mixed Models Analysis|||||1.1|-11.8|
73938662|NCT00515502|147409609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-6.1|6.4|||Mixed Models Analysis|||||6.4|-6.1|
73938663|NCT00515502|147409609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-6.1|7.5|||Mixed Models Analysis|||||7.5|-6.1|
73938664|NCT00515502|147409609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.29|||TWO_SIDED|95.0|-10.9|6.2|||Mixed Models Analysis|||||6.2|-10.9|
73938665|NCT00515502|147409610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-3.6|0.0|||Mixed Models Analysis|||||0.0|-3.6|
73938666|NCT00515502|147409610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.0|1.4|||Mixed Models Analysis|||||1.4|-2.0|
73938667|NCT00515502|147409610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-3.9|0.8|||Mixed Models Analysis|||||0.8|-3.9|
74030883|NCT00570739|147615617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.53||||0.0001|TWO_SIDED|95.0|-13.14|-5.92|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-5.92|-13.14|0.0001
73938668|NCT00515502|147409610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-3.6|1.6|||Mixed Models Analysis|||||1.6|-3.6|
73938669|NCT00515502|147409610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|-3.3|1.7|||Mixed Models Analysis|||||1.7|-3.3|
73938670|NCT00515502|147409610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|-2.0|3.4|||Mixed Models Analysis|||||3.4|-2.0|
73938671|NCT00515502|147409610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-4.1|2.9|||Mixed Models Analysis|||||2.9|-4.1|
73938672|NCT03317002|147409631|SUPERIORITY||Ratio|0.04|||<|0.001|ONE_SIDED|95.0||0.05|||Mixed Models Analysis|||||0.05||<0.001
73938673|NCT03317002|147409631|SUPERIORITY||Ratio|0.08||||0.001|ONE_SIDED|95.0||0.1|||Mixed Models Analysis|||||0.10||0.001
73938674|NCT03317002|147409632|SUPERIORITY||Ratio|0.04|||<|0.001|ONE_SIDED|95.0||0.05|||Mixed Models Analysis|||||0.05||<0.001
73938675|NCT03317002|147409632|SUPERIORITY||Ratio|0.09||||0.001|ONE_SIDED|95.0||0.12|||Mixed Models Analysis|||||0.12||0.001
73938676|NCT01426191|147409650|OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
73938677|NCT01426191|147409651|OTHER|||||||0.01|||||||Fisher Exact|||||||0.01
73938678|NCT02013622|147409655|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures (MMRM) method with model terms: baseline, visit, and baseline by visit interaction.||The null hypothesis of zero in mean change from Baseline in PANSS Total Score at Week 16 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
73938679|NCT02013622|147409656|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||<0.0001
73938680|NCT02013622|147409657|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||<0.0001
73938681|NCT02013622|147409660|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0003
73938682|NCT02013622|147409661|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0002
73938683|NCT02013622|147409662|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0177
73938684|NCT02013622|147409663|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 effectiveness||||<0.0001
74030884|NCT00570739|147615617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|||<|0.0001|TWO_SIDED|95.0|-11.35|-4.59|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-4.59|-11.35|<0.0001
74030885|NCT00570739|147615618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.57||||0.0003|TWO_SIDED|95.0|5.76|19.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||19.38|5.76|0.0003
73938685|NCT02013622|147409663|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 side effects||||0.0031
73938686|NCT02013622|147409663|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 convenience||||0.0005
73938687|NCT02013622|147409663|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 global satisfaction||||<0.0001
73938688|NCT02013622|147409664|SUPERIORITY_OR_OTHER|||||||0.5133|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (go cues)||||0.5133
73938689|NCT02013622|147409664|SUPERIORITY_OR_OTHER|||||||0.3774|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (no-go cues)||||0.3774
73938690|NCT02013622|147409665|SUPERIORITY_OR_OTHER|||||||0.8897|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (go cues)||||0.8897
73938691|NCT02013622|147409665|SUPERIORITY_OR_OTHER|||||||0.3401|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (no-go cues)||||0.3401
73938692|NCT02013622|147409666|SUPERIORITY_OR_OTHER|||||||0.4265|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DDT||||0.4265
73938693|NCT02013622|147409667|SUPERIORITY_OR_OTHER|||||||0.2923|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Delay Discounting Task k value||||0.2923
73938694|NCT02013622|147409667|SUPERIORITY_OR_OTHER|||||||0.9416|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Probability Discounting Task h value||||0.9416
73973522|NCT03812614|147489979|SUPERIORITY||Median Difference (Final Values)|-0.34||||0.45|TWO_SIDED|95.0|-1.22|0.54|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|||0.54|-1.22|0.45
73973523|NCT03812614|147489980|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.4|TWO_SIDED|95.0|-0.86|0.35|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient diabetes medication adherence was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.35|-0.86|0.40
73973524|NCT03812614|147489980|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.98|TWO_SIDED|95.0|-0.9|0.88|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.88|-0.90|0.98
74030886|NCT00570739|147615618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.52||||0.0003|TWO_SIDED|95.0|6.64|22.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||22.40|6.64|0.0003
73938695|NCT02013622|147409668|SUPERIORITY_OR_OTHER|||||||0.1815|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DRT||||0.1815
73938696|NCT02013622|147409669|SUPERIORITY_OR_OTHER|||||||0.6648|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for food||||0.6648
73938697|NCT02013622|147409669|SUPERIORITY_OR_OTHER|||||||0.9812|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for money||||0.9812
73938698|NCT02013622|147409671|SUPERIORITY_OR_OTHER|||||||0.0306|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16||||0.0306
73938699|NCT04307004|147409682|SUPERIORITY|The threshold for statistical significance was p = 0.05|Mean Difference (Final Values)|0.8|||<|0.0001|TWO_SIDED|95.0|0.5|1.1|||Paired T Test, 2-sided||Mean difference in systolic blood pressure = mean systolic blood pressure when attended - mean systolic blood pressure when not attended (i.e., unattended).|||1.1|0.5|< 0.0001
73938700|NCT04307004|147409682|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.0001|TWO_SIDED|95.0|0.3|0.7||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in diastolic blood pressure = mean diastolic blood pressure when attended - mean diastolic blood pressure when not attended (i.e., unattended)|||0.7|0.3|< 0.0001
73938701|NCT04307004|147409683|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.5||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in systolic blood pressure = mean systolic blood pressure on ambulatory blood pressure monitoring - mean systolic blood pressure on home blood pressure monitoring.|||-1.5|-3.0|< 0.0001
73938702|NCT04307004|147409683|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.4||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in diastolic blood pressure = mean diastolic blood pressure on ambulatory blood pressure monitoring - mean diastolic blood pressure on home blood pressure monitoring.|||-1.4|-2.5|< 0.0001
73973525|NCT03812614|147489980|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.43|TWO_SIDED|95.0|-1.42|0.61|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.61|-1.42|0.43
73973526|NCT03812614|147489981|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.06|TWO_SIDED|95.0|-1.0|0.01|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|||0.01|-1.00|0.06
73973527|NCT03812614|147489982|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.92|TWO_SIDED|95.0|-7.22|6.49|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient activation was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||6.49|-7.22|0.92
73973528|NCT03812614|147489983|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.02|TWO_SIDED|95.0|0.21|1.99|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient satisfaction with SP support was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.99|0.21|0.02
73973529|NCT03812614|147489984|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.06|TWO_SIDED|95.0|-0.01|0.7|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient perception of supportive and non-supportive behaviors was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.70|-0.01|0.06
74030887|NCT00570739|147615618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.08|||<|0.0001|TWO_SIDED|95.0|7.95|22.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||22.20|7.95|<0.0001
74030888|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.84||||0.0363|TWO_SIDED|95.0|0.44|13.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles||13.24|0.44|0.0363
74030889|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.39||||0.0347|TWO_SIDED|95.0|0.46|12.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles||12.31|0.46|0.0347
74030890|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31||||0.0028|TWO_SIDED|95.0|0.8|3.81||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles||3.81|0.80|0.0028
74030891|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.001|TWO_SIDED|95.0|0.96|3.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles||3.73|0.96|0.0010
74030892|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.13||||0.0006|TWO_SIDED|95.0|3.1|11.21||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles||11.21|3.10|0.0006
74030893|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.13||||0.0003|TWO_SIDED|95.0|3.35|10.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles||10.91|3.35|0.0003
74030894|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88||||0.175|TWO_SIDED|95.0|-7.04|1.29||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||1.29|-7.04|0.1750
74030895|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.23||||0.1007|TWO_SIDED|95.0|-7.1|0.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||0.63|-7.10|0.1007
74030896|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-199.3|||<|0.0001|TWO_SIDED|95.0|-272.9|-125.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-125.8|-272.9|<0.0001
74030897|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-186.1||||0.0001|TWO_SIDED|95.0|-255.9|-116.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-116.3|-255.9|0.0001
74030898|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7||||0.0466|TWO_SIDED|95.0|-23.3|-0.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles||-0.2|-23.3|0.0466
73938703|NCT04307004|147409685|OTHER|Independent variable - Attended systolic blood pressure. Dependent variable - Left ventricular mass index.|beta coefficient|0.43|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.32|0.55|||Regression, Linear|||We determined the association between attended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.32|< 0.001
73938704|NCT04307004|147409685|OTHER|Independent variable - attended diastolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.24|0.6|||Regression, Linear|||We determined the association between attended diastolic blood pressure measurements and left ventricular mass index (LVMI). This analysis included 587 with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.60|0.24|< 0.001
73938705|NCT04307004|147409685|OTHER|Independent variable - unattended systolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.44|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.33|0.56|||Regression, Linear|||We determined the association between unattended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.56|0.33|< 0.001
73938706|NCT04307004|147409685|OTHER|Independent variable - unattended diastolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.19|0.55|||Regression, Linear|||We determined the association between unattended diastolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.19|< 0.001
74030899|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7||||0.057|TWO_SIDED|95.0|-21.8|0.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles||0.3|-21.8|0.0570
74030900|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-77.7||||0.0004|TWO_SIDED|95.0|-120.3|-35.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||-35.0|-120.3|0.0004
73938707|NCT04307004|147409685|OTHER|Independent variable - awake systolic blood pressure on ABPM Dependent variable - left ventricular mass index.|beta coefficient|0.61|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.47|0.74|||Regression, Linear|||We determined the association between awake systolic blood pressure from ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.74|0.47|< 0.001
73938708|NCT04307004|147409685|OTHER|Independent variable - awake diastolic blood pressure on ABPM. Dependent variable - left ventricular mass index.|beta coefficient|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.25|0.66|||Regression, Linear|||We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.66|0.25|< 0.001
73938709|NCT04307004|147409685|OTHER|Independent variable - asleep systolic blood pressure on HBPM. Dependent variable - left ventricular mass index.|beta coefficient|0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.19|0.44|||Regression, Linear|||We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with HBPM data and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.44|0.19|< 0.001
73938710|NCT04307004|147409685|OTHER|Independent variable - asleep diastolic blood pressure on HBPM Dependent variable - left ventricular mass index|beta coefficient|0.23|STANDARD_ERROR_OF_MEAN|0.09||0.01|TWO_SIDED|95.0|0.05|0.4|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on HBPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.40|0.05|0.01
73938711|NCT04307004|147409685|OTHER|Independent variable - asleep systolic blood pressure on ABPM. Dependent variable - left ventricular mass index.|beta coefficient|0.45|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.32|0.59|||Regression, Linear|||We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.59|0.32|< 0.001
73938712|NCT04307004|147409685|OTHER|Independent variable - asleep diastolic blood pressure on ABPM Dependent variable - left ventricular mass index.|beta coefficient|0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.16|0.55|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.16|< 0.001
73938713|NCT04307004|147409686|OTHER|Independent variable - attended systolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.17|TWO_SIDED|95.0|-0.47|0.08|||Regression, Linear|||We determined the association between attended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.08|-0.47|0.17
73938714|NCT04307004|147409686|OTHER|Independent variable - attended diastolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.28|STANDARD_ERROR_OF_MEAN|0.22||0.2|TWO_SIDED|95.0|-0.7|0.15|||Regression, Linear|||We determined the association between attended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.15|-0.70|0.20
73938715|NCT04307004|147409686|OTHER|Independent variable - unattended systolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.07|TWO_SIDED|95.0|-0.55|0.02|||Regression, Linear|||We determined the association between unattended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.02|-0.55|0.07
73938716|NCT04307004|147409686|OTHER|Independent variable - unattended diastolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.09|TWO_SIDED|95.0|-0.8|0.06|||Regression, Linear|||We determined the association between unattended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended diastolic blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.06|-0.80|0.09
73973530|NCT03812614|147489985|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.49|TWO_SIDED|95.0|-2.19|4.57|||Mixed Models Analysis|||Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.|Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|4.57|-2.19|0.49
73938717|NCT04307004|147409686|OTHER|"Independent variable - awake systolic blood pressure on ambulatory blood pressure monitoring.~Dependent variable - urinary albumin-to-creatinine ratio."|beta coefficient|0.01|STANDARD_ERROR_OF_MEAN|0.15||0.94|TWO_SIDED|95.0|-0.29|0.31|||Regression, Linear|||We determined the association between awake systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.31|-0.29|0.94
73866822|NCT01532869|147278817|SUPERIORITY_OR_OTHER||Difference in LS mean|-3.55||||0.0579|TWO_SIDED|95.0|-7.23|0.12|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.12|-7.23|0.0579
73866823|NCT01532869|147278818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|STANDARD_ERROR_OF_MEAN|0.704||0.2159|TWO_SIDED|95.0|0.6|9.5|||Regression, Logistic|||The logistic regression model included the fixed categorical effects of treatment and the stratification factor of joint involvement at the baseline visit. The continuous covariate of baseline mRSS score was also included in the model.||9.50|0.60|0.2159
73866824|NCT02540993|147278855|SUPERIORITY||Hazard Ratio (HR)|0.825|||=|0.0014|TWO_SIDED|95.0|0.732|0.928||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.03282695.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.928|0.732|= 0.0014
73866825|NCT02540993|147278856|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.0339|TWO_SIDED|95.0|0.747|0.989||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.989|0.747|= 0.0339
73866826|NCT02540993|147278857|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.895|||=|0.2348|TWO_SIDED|95.0|0.746|1.075||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.075|0.746|= 0.2348
73866827|NCT02540993|147278858|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.946|||=|0.1623|TWO_SIDED|95.0|0.876|1.022||P-value from stratified log-rank test.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.022|0.876|= 0.1623
73866828|NCT02540993|147278859|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Ratio of least squares means|0.688|||<|0.0001|TWO_SIDED|95.0|0.662|0.715||P-value from F-test of equal means between the treatment groups.|ANCOVA|||||0.715|0.662|< 0.0001
73938718|NCT04307004|147409686|OTHER|"Independent variable - awake diastolic blood pressure on ambulatory blood pressure monitoring.~Dependent variable - urinary albumin-to-creatinine ratio."|beta coefficient|0.22|STANDARD_ERROR_OF_MEAN|0.22||0.31|TWO_SIDED|95.0|-0.21|0.66|||Regression, Linear|||We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.66|-0.21|0.31
73938719|NCT04307004|147409686|OTHER|Independent variable - asleep systolic blood pressure on HBPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.94|TWO_SIDED|95.0|-0.28|0.26|||Regression, Linear|||We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.26|-0.28|0.94
73938720|NCT04307004|147409686|OTHER|Independent variable - asleep diastolic blood pressure on HBPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.93|TWO_SIDED|95.0|-0.4|0.36|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.36|-0.40|0.93
73957879|NCT02263508|147451284|OTHER||Odds Ratio (OR)|1.59||||0.004|TWO_SIDED|95.0|1.16|2.17|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||2.17|1.16|0.004
73866829|NCT02540993|147278860|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.763|||=|0.0012|TWO_SIDED|95.0|0.648|0.9||P-value from stratified log-rank test.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.900|0.648|= 0.0012
73866830|NCT01009086|147278868|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866831|NCT01009086|147278868|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866832|NCT01009086|147278868|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866833|NCT01009086|147278869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866834|NCT01009086|147278869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73938721|NCT04307004|147409686|OTHER|Independent variable - asleep systolic blood pressure on ABPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.15||0.54|TWO_SIDED|95.0|-0.21|0.4|||Regression, Linear|||We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.40|-0.21|0.54
73938722|NCT04307004|147409686|OTHER|Independent variable - asleep diastolic blood pressure on ABPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|0.26|STANDARD_ERROR_OF_MEAN|0.21||0.23|TWO_SIDED|95.0|-0.16|0.68|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.68|-0.16|0.23
73938723|NCT01270347|147409747|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the LS mean difference 95% CI for relative change from Baseline to Day 28 in FEV1 percent predicted was \> -4%.|LSMean difference|1.86||||0.1481|TWO_SIDED|95.0|-0.66|4.39|||ANCOVA||Estimates were determined from an analysis of covariance model with terms for treatment, region (US, non-US), and age (12 to 18 years, \> 18 years), and Baseline FEV1 (\< 55%, . 55%).|||4.39|-0.66|0.1481
73938724|NCT01270347|147409748|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in FEV1 percent predicted is \> -4%.|LSMean difference|4.968||||0.083|TWO_SIDED|95.0|-0.653|10.59|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), \& baseline as a covariate.|||10.590|-0.653|0.0830
73938725|NCT01270347|147409749|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in FEV1 percent predicted is \> -4%.|LSMean difference|1.57||||0.0945|TWO_SIDED|95.0|-0.272|3.411|||ANCOVA||Estimates are determined from a repeated measures model with terms for treatment, visit, the interaction between treatment group and visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline as a covariate.|||3.411|-0.272|0.0945
73938726|NCT01270347|147409752|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in Pseudomonas Aeruginosa Sputum Density is \> -4%|LSMean difference|0.44||||0.053|TWO_SIDED|95.0|-0.01|0.88|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.|||0.88|-0.01|0.0530
73938727|NCT01270347|147409754|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in Respiratory Domain of the CFQ-R is \> -4%|LSMean difference|3.19||||0.0463|TWO_SIDED|95.0|0.05|6.32|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline value.|||6.32|0.05|0.0463
73938728|NCT00529399|147409759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.98
74030901|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-69.3||||0.0007|TWO_SIDED|95.0|-109.2|-29.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||-29.3|-109.2|0.0007
73866835|NCT01009086|147278869|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866836|NCT01009086|147278870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866837|NCT01009086|147278870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866838|NCT01009086|147278870|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73938729|NCT00529399|147409759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.51
73938730|NCT02486328|147409760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73938731|NCT02486328|147409761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73938732|NCT02486328|147409762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73938733|NCT02486328|147409763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
73938734|NCT02486328|147409764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
73866839|NCT01009086|147278871|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866840|NCT01009086|147278871|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866841|NCT01009086|147278871|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866842|NCT01009086|147278872|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866843|NCT01009086|147278872|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73938735|NCT02486328|147409765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
73938736|NCT06242444|147409766|SUPERIORITY||Adjusted Mean Difference|8.35|STANDARD_ERROR_OF_MEAN|2.465||0.0012|TWO_SIDED|95.0|3.42|13.28|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Placebo Control Dentifrice.|||13.28|3.42|0.0012
73938737|NCT06242444|147409767|SUPERIORITY||Adjusted Mean Difference|37.33|STANDARD_ERROR_OF_MEAN|3.217|<|0.0001|TWO_SIDED|95.0|30.9|43.76|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Placebo Control Dentifrice.|||43.76|30.90|<.0001
73938738|NCT06242444|147409768|SUPERIORITY||Adjusted Mean Difference|3.95|STANDARD_ERROR_OF_MEAN|2.462||0.1138|TWO_SIDED|95.0|-0.97|8.87|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Reference Dentifrice.|||8.87|-0.97|0.1138
73938739|NCT06242444|147409770|SUPERIORITY||Adjusted Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|3.213||0.493|TWO_SIDED|95.0|-4.21|8.64|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Reference Dentifrice.|||8.64|-4.21|0.4930
73938740|NCT06242444|147409774|SUPERIORITY||Adjusted Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|2.462||0.0789|TWO_SIDED|95.0|-0.52|9.32|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||9.32|-0.52|0.0789
73938741|NCT06242444|147409774|SUPERIORITY||Adjusted Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.408||0.2178|TWO_SIDED|95.0|-1.82|7.81|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||7.81|-1.82|0.2178
73938742|NCT06242444|147409775|SUPERIORITY||Adjusted Mean Difference|35.12|STANDARD_ERROR_OF_MEAN|3.213|<|0.0001|TWO_SIDED|95.0|28.69|41.54|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||41.54|28.69|<.0001
73938743|NCT06242444|147409775|SUPERIORITY||Adjusted Mean Difference|27.18|STANDARD_ERROR_OF_MEAN|3.018|<|0.0001|TWO_SIDED|95.0|21.14|33.21|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||33.21|21.14|<.0001
73938744|NCT06242444|147409776|SUPERIORITY||Geometric Mean Ratio|1.73|||<|0.0001|TWO_SIDED|95.0|1.53|1.97|||Mixed Models Analysis|||At 4 hours of intra-oral exposure||1.97|1.53|<.0001
73938745|NCT06242444|147409776|SUPERIORITY||Geometric Mean Ratio|1.59|||<|0.0001|TWO_SIDED|95.0|1.42|1.78|||Mixed Models Analysis|||At 12 hours of intra-oral exposure||1.78|1.42|<.0001
73938746|NCT06242444|147409777|SUPERIORITY||Adjusted Mean Difference|0.307|STANDARD_ERROR_OF_MEAN|0.0277|<|0.0001|TWO_SIDED|95.0|0.252|0.362|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||0.362|0.252|<.0001
73973531|NCT03812614|147489986|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.08|TWO_SIDED|95.0|-0.09|1.66|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||1.66|-0.09|0.08
73973532|NCT05123027|147490017|SUPERIORITY||Risk Ratio (RR)|0.7||||0.399|TWO_SIDED|95.0|0.3|1.62||Threshold for significance: p\< 0.05|Mixed Models Analysis|||The primary outcome was analyzed with a longitudinal mixed effects negative binomial model incorporating the total score at earlier time points as well as 180 days. Fixed effect covariates included baseline score, treatment, days, site, stratum, and an interaction between treatment and days. A random effect was included to account for correlation within each participant.||1.62|0.30|0.399
73938747|NCT06242444|147409777|SUPERIORITY||Adjusted Mean Difference|0.242|STANDARD_ERROR_OF_MEAN|0.0257|<|0.0001|TWO_SIDED|95.0|0.19|0.293|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||0.293|0.190|<.0001
73938748|NCT02415400|147409816|NON_INFERIORITY|Non-Inferiority (NI) margin = 1.2|||||<|0.0001|||||||1-sided p-value for NI test|||Separate hierarchical testing was performed for apixaban vs VKA: 1) Non-inferiority for the primary endpoint.||||<0.0001
73973533|NCT05123027|147490018|SUPERIORITY||Risk Ratio (RR)|1.09||||0.53|TWO_SIDED|95.0|0.83|1.45||Threshold for significance: p\< 0.05|Mixed Models Analysis|||This was modeled similar to the primary outcome, an over dispersed Poisson regression model with fixed effect covariates for treatment arm, treatment days, site, and stratum with an interaction between treatment arm and treatment days. Note that no baseline score covariate was included as all participants will be considered to have achieved 0 steps at baseline. A random intercept was included for each subject to account for repeated measures.||1.45|0.83|0.53
73938749|NCT02415400|147409816|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint||0.82|0.58|<0.0001
73938750|NCT02415400|147409817|SUPERIORITY||Hazard Ratio (HR)|1.88|||<|0.0001|TWO_SIDED|95.0|1.58|2.23|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for aspirin vs placebo: 2) Superiority for the primary endpoint.||2.23|1.58|<0.0001
73938751|NCT02415400|147409818|SUPERIORITY||||||<|0.0001|||||||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint.||||<0.0001
73938752|NCT02415400|147409819|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0033|TWO_SIDED|95.0|0.75|0.94|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 3) Superiority for all-cause death and all-cause rehospitalization.||0.94|0.75|0.0033
73938753|NCT02415400|147409820|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.2219|TWO_SIDED|95.0|0.96|1.2|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 3) Superiority for all-cause death and all-cause rehospitalization.||1.20|0.96|0.2219
73938754|NCT02415400|147409821|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.437|TWO_SIDED|95.0|0.75|1.13|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 4) Superiority for all-cause death and ischemic events.||1.13|0.75|0.4370
73938755|NCT02415400|147409822|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1742|TWO_SIDED|95.0|0.7|1.07|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 4) Superiority for all-cause death and ischemic events.||1.07|0.70|0.1742
73973534|NCT03735979|147490019|SUPERIORITY||Posterior Mean Difference (Final Values)|-1.51|STANDARD_DEVIATION|0.51||0.002|TWO_SIDED|||||"The P-value is the posterior probability that study drug has a higher benefit than control. The a priori threshold for a successful trial is 0.985.~The posterior probability that argatroban was better than placebo was 0.002."|Bayesian|Primary analysis compared treatment group with placebo, with adjustment for baseline NIHSS score in a Bayesian normal dynamic linear model.|The posterior mean of study treatment minus placebo.|||||0.002
73938756|NCT02270450|147409823|SUPERIORITY||Mean Difference (Net)|2.87|STANDARD_ERROR_OF_MEAN|4.3||0.5|TWO_SIDED|||||A p-value less than 0.05 is considered statistically significant.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|"A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of good days between patients assigned to surgery and patients assigned to non-surgical management."||||0.50
73938757|NCT02270450|147409824|SUPERIORITY||Mean Difference (Net)|-1.09||||0.64|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the length of the initial hospital stay between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.64
73938758|NCT02270450|147409825|SUPERIORITY||Odds Ratio (OR)|0.82||||0.6|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Logistic|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares NG tube use vs no NG tube use between patients assigned to surgery and patients assigned to non-surgical management.||||0.60
73938759|NCT02270450|147409826|SUPERIORITY||Mean Difference (Net)|0.64||||0.47|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of days of NG tube use between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.47
73938760|NCT02270450|147409827|SUPERIORITY||Mean Difference (Net)|-4.1||||0.001|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for nausea severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.001
73938761|NCT02270450|147409827|SUPERIORITY||Mean Difference (Net)|-1.63||||0.008|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for vomiting severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.008
73973535|NCT03735979|147490019|SUPERIORITY||Posterior Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|0.29||0.04|TWO_SIDED|||||"The P-value is the posterior probability that study drug has a higher benefit than control. The a priori threshold for a successful trial is 0.985.~The posterior probability that eptifibitide was better than placebo was 0.04."|Bayesian|Primary analysis compared treatment group with placebo, with adjustment for baseline NIHSS score in a Bayesian normal dynamic linear model.|The posterior mean of study treatment minus placebo.|||||0.04
73973536|NCT05654662|147490053|SUPERIORITY|||||||0.0032|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||0.0032
73973537|NCT05654662|147490054|SUPERIORITY||Adjusted Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.03||0.0013|TWO_SIDED|95.0|-10.6|-2.6|||Mixed Model with Repeated Measure (MMRM)||Adjusted mean difference was calculated as test product minus reference product.|||-2.6|-10.6|0.0013
73973538|NCT05654662|147490055|SUPERIORITY|||||||0.0181|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||0.0181
73973539|NCT05654662|147490055|SUPERIORITY|||||||0.0541|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||0.0541
73973540|NCT05654662|147490056|SUPERIORITY||Adjusted Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.44||0.0091|TWO_SIDED|95.0|-6.7|-1.0|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-1.0|-6.7|0.0091
73973541|NCT05654662|147490056|SUPERIORITY||Adjusted Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.78||0.0031|TWO_SIDED|95.0|-8.8|-1.8|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-1.8|-8.8|0.0031
73973542|NCT05654662|147490057|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
73866844|NCT01009086|147278872|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866845|NCT01009086|147278873|SUPERIORITY_OR_OTHER|||||||0.017|||||||re-randomization test|||||||0.017
73973543|NCT05654662|147490057|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
73938762|NCT02270450|147409827|SUPERIORITY||Mean Difference (Net)|-1.31||||0.04|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for bloating severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.04
74030902|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-109.9||||0.0124|TWO_SIDED|95.0|-195.8|-23.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||-23.9|-195.8|0.0124
73938763|NCT02270450|147409827|SUPERIORITY||Mean Difference (Net)|-3.6||||0.01|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for pain severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.01
73973544|NCT05654662|147490057|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
73973545|NCT05654662|147490058|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.011||0.0051|TWO_SIDED|95.0|-0.05|-0.01|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.01|-0.05|0.0051
73973546|NCT05654662|147490058|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.013||0.0034|TWO_SIDED|95.0|-0.07|-0.01|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.01|-0.07|0.0034
73973547|NCT05654662|147490058|SUPERIORITY||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.015||0.0022|TWO_SIDED|95.0|-0.08|-0.02|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.02|-0.08|0.0022
73973548|NCT05654662|147490059|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
73973549|NCT05654662|147490059|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
73973550|NCT05654662|147490059|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
74030903|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.8||||0.0098|TWO_SIDED|95.0|-187.6|-26.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||-26.0|-187.6|0.0098
74030904|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2||||0.102|TWO_SIDED|95.0|-35.6|3.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||3.2|-35.6|0.1020
73973551|NCT05654662|147490060|SUPERIORITY||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.12|-0.04|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.04|-0.12|<0.0001
73973552|NCT05654662|147490060|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|-0.18|-0.07|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.07|-0.18|<0.0001
73973553|NCT05654662|147490060|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.2|-0.08|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.08|-0.20|<0.0001
73973554|NCT05654662|147490061|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
73973555|NCT05654662|147490061|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
73973556|NCT05654662|147490061|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
73973557|NCT05654662|147490062|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.047||0.0012|TWO_SIDED|95.0|-0.25|-0.06|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.06|-0.25|0.0012
73973558|NCT05654662|147490062|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.061||0.0058|TWO_SIDED|95.0|-0.29|-0.05|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.05|-0.29|0.0058
73973559|NCT05654662|147490062|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.42|-0.16|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.16|-0.42|<0.0001
73973560|NCT05654662|147490063|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
73973561|NCT05654662|147490063|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
73973562|NCT05654662|147490063|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
74030905|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4||||0.0997|TWO_SIDED|95.0|-33.8|3.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||3.0|-33.8|0.0997
74030906|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-93.7||||0.0069|TWO_SIDED|95.0|-161.6|-25.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||-25.9|-161.6|0.0069
73866846|NCT01009086|147278873|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73938764|NCT02270450|147409827|SUPERIORITY||Mean Difference (Net)|-1.9||||0.007|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for constipation severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.007
73938765|NCT02270450|147409828|SUPERIORITY||Odds Ratio (OR)|0.64||||0.52|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Logistic|Adjusted for treatment, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares ability to eat between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.52
73938766|NCT02270450|147409829|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.12|TWO_SIDED|95.0|0.45|1.09|||Regression, Cox|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A Cox proportional hazards regression model stratified by pathway (randomized vs Patient Choice) was used to estimate the effect of treatment assignment (surgery vs non-surgical management) on overall survival.||1.09|0.45|0.12
73938767|NCT01968213|147409837|SUPERIORITY||Cox Proportional Hazard|0.365|||<|0.0001|TWO_SIDED|95.0|0.295|0.451|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.|0.451|0.295|<0.0001
73938768|NCT01968213|147409838|SUPERIORITY||Cox Proportional Hazard|0.354|||<|0.0001|TWO_SIDED|95.0|0.278|0.45|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.|0.450|0.278|<0.0001
73938769|NCT02491671|147409855|SUPERIORITY||Risk Ratio (RR)|1.219||||0.171|TWO_SIDED|95.0|0.891|1.583|||Chi-squared|||||1.583|0.891|0.171
73938770|NCT02491671|147409856|SUPERIORITY||z|0.288|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Wilcoxon rank-sum (Mann-Whitney) test Unadjusted variance 274999.00 Adjustment for ties --21069.78 Adjusted variance 253929.22 z = 0.288; Prob \> \|z\| = 0.7735"|||||>0.05
73938771|NCT02491671|147409857|SUPERIORITY||Risk Ratio (RR)|1.351||||0.307|TWO_SIDED|95.0|0.657|1.879|||Chi-squared|||||1.879|0.657|0 .307
73938772|NCT02251990|147409860|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p-value was based on a one-sided asymptotic test for a binomial proportion. A one-sided p-value \<0.0125 was considered supportive of a conclusion that the true SVR12 is \>73%.|one-sided asymptotic test|||A one-sided Wald test was used to test the null hypothesis, which was that the SVR12 rate for the ITG was ≤ the historical reference rate of 73%. The historical reference SVR rate for treatment-naive genotype 1 predominantly Asian participants treated with pegylated interferon/ribavirin was derived from 2 studies (PMCID: PMC417, PMCID: PMC3644280) after adjusting for an expected improved safety profile related to an interferon-free regimen.||||<0.001
73938773|NCT02251990|147409861|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.5|||||TWO_SIDED|95.0|-10.6|9.6||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.||9.6|-10.6|
73938774|NCT02251990|147409862|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.5|||||TWO_SIDED|95.0|-4.2|0.9||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.||0.9|-4.2|
73938775|NCT03265600|147409865|SUPERIORITY||Odds Ratio (OR)|2.91||||0.006|TWO_SIDED||||||Unadjusted bivariate logistic regression|||||||0.006
73938776|NCT03265600|147409866|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Cohen's d: -0.25||||||0.19
73938777|NCT03265600|147409867|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|Cohen's d: -0.36||||||0.12
73866847|NCT01009086|147278873|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73866848|NCT01192828|147278875|OTHER|Descriptive analysis||||||0.235|||||||t-test, 2 sided|paired||Null hypothesis applied.||||0.235
73866849|NCT01192828|147278876|OTHER|Descriptive analysis.||||||0.701|||||||t-test, 2 sided|paired||Null hypothesis assumed.||||0.701
73938778|NCT03265600|147409868|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|Cohen's d: -0.34||||||0.08
73938779|NCT03265600|147409869|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.57||||||<0.001
73938780|NCT03265600|147409870|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|Cohen's d: 0.41||||||0.03
73938781|NCT03265600|147409871|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|Cohen's d: 0.15||||||0.31
73938782|NCT03265600|147409872|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Cohen's d: 0.22||||||0.26
73938783|NCT03265600|147409873|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: -0.58||||||<0.001
73938784|NCT03265600|147409874|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.75||||||<0.001
73957880|NCT02263508|147451286|OTHER||Odds Ratio (OR)|1.35||||0.058|TWO_SIDED|95.0|0.99|1.85|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.85|0.99|0.058
74030907|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-91.4||||0.0052|TWO_SIDED|95.0|-155.2|-27.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||-27.5|-155.2|0.0052
73938785|NCT00535730|147409875|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis of VZV antibody titers is 92%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval on the VZV antibody GMT ratio\[concomitant/nonconcomitant\] being \>0.67.||||||0.244||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to that in subjects who receive ZOSTAVAX™ nonconcomitantly||||0.244
73938786|NCT00535730|147409877|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|t-test, 1 sided|The one-sided p-value for testing acceptability for GMFR is computed based on t-test. CI is computed based on the t distribution||The hypothesis was that ZOSTAVAX™ elicits an acceptable VZV antibody response when administered concomitantly with PNEUMOVAX™ 23.||||<0.001
73938787|NCT00535730|147409878|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||"The hypothesis was that the GMT of the PnPs antibody response to serotype 3 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who~receive ZOSTAVAX™ nonconcomitantly."||||<0.001
73938788|NCT00535730|147409879|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 14 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
73938789|NCT00535730|147409880|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 19A at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
73938790|NCT00535730|147409881|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 22F at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
73938791|NCT00936858|147409907|OTHER||6 month PFS probability|0.35|||||TWO_SIDED|||||||||We will declare the trial a success after observing 7 or more patients with PFS within 6 months. The study will have alpha = 0.092 and power =0.970, assuming a 6 month PFS probability of 0.12 for the null and a PFS probability of 0.35 as the alternative hypothesis.||||
73938792|NCT00417079|147409960|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A 2-sided significance level of 0.0452 was used for the final analysis based on an interim analysis performed after 307 events with an adjusted significance level of 0.016 based on the O'Brien-Fleming type 1 error spending function.|Log Rank|Analysis was performed by using a log-rank comparisons stratified according to disease measurability and ECOG performance status (0-1 versus 2)||The study required an estimated sample size of 720 patients (360 per arm) in order to detect a 25% reduction in the hazard ratio for death in the cabazitaxel group relative to the mitoxantrone group with 90% power. The final analysis was planned for when 511 deaths had occurred.||||<0.0001
73938793|NCT00417079|147409961|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
73938794|NCT00417079|147409962|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Chi-squared|||||||0.0005
73938795|NCT00417079|147409963|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61|||<|0.0001|TWO_SIDED|95.0|0.49|0.76|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||0.76|0.49|<0.0001
73938796|NCT00417079|147409964|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.75||||0.001|TWO_SIDED|95.0|0.63|0.9|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||0.90|0.63|0.0010
73938797|NCT00417079|147409965|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Chi-squared|||||||0.0002
73938798|NCT00417079|147409966|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.5192|TWO_SIDED|95.0|0.69|1.19|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||1.19|0.69|0.5192
73938799|NCT00417079|147409967|SUPERIORITY_OR_OTHER|||||||0.6286||95.0|||||Chi-squared|||||||0.6286
73938800|NCT04403698|147409978|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||linear mixed models were used to compare bone turnover markers (CTX-I) between both treatment groups. These models were performed with an intention to treat approach, where drop-outs were considered as non-responders. The models accounted for repeated measures.||||<0.01
73938801|NCT04403698|147409979|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||linear mixed models were used to compare bone turnover markers (PINP) between both treatment groups. These models were performed with an intention to treat approach, where drop-outs were considered as non-responders. The models accounted for repeated measures.||||0.05
73938802|NCT04403698|147409980|SUPERIORITY|||||||0.042|||||||Fisher Exact|||A Fisher's exact test was used to assess differences in patient numbers exceeding reference ranges between both treatment groups at week 48||||0.042
73938803|NCT04403698|147409981|SUPERIORITY|||||||0.042|||||||Fisher Exact|||A Fisher's exact test was used to assess differences in patient numbers exceeding reference ranges between both treatment groups.||||0.042
73938804|NCT03336619|147409989|SUPERIORITY|||||||0.3765|||||||Gehan-Wilcoxon|Analysis used a Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.3765
73938805|NCT03336619|147409990|SUPERIORITY|||||||0.6331|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.6331
73938806|NCT03336619|147409991|SUPERIORITY|||||||0.7382|||||||Fisher Exact|||||||0.7382
73938807|NCT03336619|147409992|SUPERIORITY|||||||0.3236|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset to enrollment and influenza vaccination status.||||||0.3236
73938808|NCT03336619|147409993|SUPERIORITY|||||||0.0483|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.0483
73938809|NCT00617344|147410016|OTHER|The associated 95% confidence intervals (CIs) for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||TWO_SIDED|95.0|-7.44|2.84||||||Dengue Virus Serotype 1: Pre-injection 1 (Day 0)||2.84|-7.44|
73938810|NCT00617344|147410016|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-15.5|||||TWO_SIDED|95.0|-28.4|-2.0||||||Dengue Virus Serotype 1: 30 days post-injection 2||-2.00|-28.4|
73938811|NCT00617344|147410016|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||TWO_SIDED|95.0|-7.44|2.84||||||Dengue Virus Serotype 2: Pre-injection 1 (Day 0)||2.84|-7.44|
73938812|NCT00617344|147410016|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-3.1|||||TWO_SIDED|95.0|-15.0|8.75||||||Dengue Virus Serotype 2: 30 days post-injection 2||8.75|-15.0|
73938813|NCT00617344|147410016|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|1.0|||||TWO_SIDED|95.0|-9.09|11.1||||||Dengue Virus Serotype 3: Pre-injection 1 (Day 0)||11.1|-9.09|
73938814|NCT00617344|147410016|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-5.7|||||TWO_SIDED|95.0|-15.6|3.81||||||Dengue Virus Serotype 3: 30 days post-injection 2||3.81|-15.6|
73938815|NCT00617344|147410016|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-4.0|||||TWO_SIDED|95.0|-10.9|2.49||||||Dengue Virus Serotype 4: Pre-injection 1 (Day 0)||2.49|-10.9|
73938816|NCT00617344|147410016|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|31.4|||||TWO_SIDED|95.0|18.2|43.2||||||Dengue Virus Serotype 4: 30 days post-injection 2||43.2|18.2|
73938817|NCT00506493|147410027|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportions|42.6|STANDARD_ERROR_OF_MEAN|6.3|<|0.01|ONE_SIDED|97.5|30.0|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percent of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%"|||30.0|<0.01
73938818|NCT00506493|147410028|SUPERIORITY_OR_OTHER_LEGACY||binomial proportions|6.7|||<|0.0001|ONE_SIDED|97.5||14.9|||Fisher Exact|||||14.9||<0.0001
73938819|NCT01760239|147410031|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
73938820|NCT01760239|147410032|SUPERIORITY||Odds Ratio (OR)|2.36||||0.046|TWO_SIDED||||||Mixed Models Analysis|||||||.046
73938821|NCT01760239|147410033|SUPERIORITY||Odds Ratio (OR)|5.13||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
73938822|NCT02985866|147410034|SUPERIORITY|The first co-primary end point was superiority of CLC over SAP in terms of CGM-measured time below 70 mg/dL. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.|||||<|0.0001||||||To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.||||<0.0001
73866850|NCT01192828|147278877|OTHER|Descriptive analysis.||||||0.19|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.190
73938823|NCT02985866|147410035|NON_INFERIORITY|The second co-primary end point was noninferiority in CGM-measured time above 180 mg/dL, with a noninferiority limit of 5%. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.|||||<|0.0001||||||To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.||||<0.0001
73938824|NCT02985866|147410036|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
73938825|NCT02985866|147410037|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
73938826|NCT02985866|147410038|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
73938827|NCT02985866|147410039|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
73938828|NCT02985866|147410040|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
73938829|NCT02985866|147410041|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
73938830|NCT02985866|147410042|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
73938831|NCT00686166|147410045|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Exact binomal test|||||||0.18
73938832|NCT02216123|147410058|OTHER||Mean Difference (Final Values)|1.23|||||TWO_SIDED|95.0|-4.161|4.982|||||Confidence interval for the treatment difference was based on the Newcombe method. Percent treatment difference (TQ+CQ-PQ+CQ) has been presented.|||4.982|-4.161|
73938833|NCT02216123|147410060|OTHER||Hazard Ratio (HR)|0.984||||||95.0|0.577|1.678|||||Hazards ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio \<1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.|||1.678|0.577|
73938834|NCT02216123|147410061|OTHER||Hazard Ratio (HR)|0.815|||||TWO_SIDED|95.0|0.442|1.503|||||Hazard ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio\<1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.|||1.503|0.442|
73938835|NCT00464815|147410119|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix Group minus Mencevax ACWY Group) in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|7.87|||||TWO_SIDED|95.0|1.63|14.87||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup A (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||14.87|1.63|
73938836|NCT00464815|147410119|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate Difference|0.67|||||TWO_SIDED|95.0|-1.65|4.18||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenC vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup C (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||4.18|-1.65|
73973563|NCT05654662|147490064|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.051||0.0022|TWO_SIDED|95.0|-0.26|-0.06|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.06|-0.26|0.0022
73866851|NCT01192828|147278878|OTHER|Descriptive analysis.||||||0.052|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.052
73938837|NCT00464815|147410119|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|8.9|||||TWO_SIDED|95.0|4.78|14.14||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenW-135 vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup W-135 (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||14.14|4.78|
73938838|NCT00464815|147410119|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|15.22|||||TWO_SIDED|95.0|9.89|21.37||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenY vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup Y (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||21.37|9.89|
73938839|NCT00464815|147410120|NON_INFERIORITY|Criterion for non-inferiority: the upper limit (UL) of the 2-sided standardized asymptotic 95% CI for the ratio of the percentages of subjects with any Grade 3 general symptom was lower than or equal to (≤) the pre-defined clinical limit of 3.0.|Risk Ratio (RR)|4.02||||0.1456|TWO_SIDED|95.0|0.68|24.6|||Chi-squared|||To demonstrate the non-inferiority of Nimenrix™ vaccine versus Mencevax™ vaccine in terms of incidence of any Grade 3 general (solicited and unsolicited) symptom, the 2-sided standardised asymptotic 95% CI for the ratio between Nimenrix and Mencevax groups (Nimenrix over Mencevax) in the percentage of subjects with any grade 3 general symptom within 4 days after vaccination was computed for the safety analysis in study MenACWY-TT-036.||24.6|0.68|0.1456
73938840|NCT00000392|147410133|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||ANOVA|||||||0.18
73938841|NCT05098054|147410168|OTHER||Geometric Least-squares mean(GLSM) Ratio|214.93|||||TWO_SIDED|90.0|103.47|446.45|||||"Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||446.45|103.47|
73938842|NCT05098054|147410168|OTHER||GLSM Ratio|145.42|||||TWO_SIDED|90.0|77.18|273.98|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||273.98|77.18|
73938843|NCT05098054|147410169|OTHER||GLSM Ratio|299.21|||||TWO_SIDED|90.0|111.75|801.17|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||801.17|111.75|
73938844|NCT05098054|147410169|OTHER||GLSM Ratio|130.25|||||TWO_SIDED|90.0|77.02|220.26|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||220.26|77.02|
73973564|NCT05654662|147490064|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.066||0.0099|TWO_SIDED|95.0|-0.3|-0.04|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.04|-0.30|0.0099
73973565|NCT05654662|147490064|SUPERIORITY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.073|<|0.0001|TWO_SIDED|95.0|-0.45|-0.16|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.16|-0.45|<0.0001
73973566|NCT04499521|147490085|OTHER||Median Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.27|0.5||||||Mean difference between Gauze and Gel ARM A Bladder D2cc||0.50|-0.27|
73973567|NCT04499521|147490085|OTHER||Median Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.94|0.96||||||Mean difference between Gauze and Gel ARM B Bladder D2cc||0.96|-0.94|
73973568|NCT04499521|147490085|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.54|0.16||||||Mean difference between Gauze and Gel ARM A Rectum D2cc||0.16|-0.54|
74030908|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.0524|TWO_SIDED|95.0|-0.01|1.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.90|-0.01|0.0524
73938845|NCT05098054|147410170|OTHER||GLSM Ratio|316.27|||||TWO_SIDED|90.0|117.68|849.97|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||849.97|117.68|
73866852|NCT01192828|147278879|OTHER|Descriptive analysis.||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed.||||0.014
73938846|NCT05098054|147410170|OTHER||GLSM Ratio|135.26|||||TWO_SIDED|90.0|91.22|200.57|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||200.57|91.22|
73938847|NCT01654549|147410201|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.94
73973569|NCT04499521|147490085|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.67|0.29||||||Mean difference between Gauze and Gel ARM B Rectum D2cc||0.29|-0.67|
73973570|NCT05525104|147490088|SUPERIORITY|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||||||0.041
73973571|NCT05525104|147490089|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
73973572|NCT05525104|147490093|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73973573|NCT03498521|147490137|SUPERIORITY||Stratified Cox proportional hazard|0.72||||0.0079|TWO_SIDED|95.0|0.56|0.92|||Stratified log-rank|||||0.92|0.56|0.0079
73973574|NCT01474122|147490184|SUPERIORITY_OR_OTHER_LEGACY||NB-2 estimate of new DUs per patient|1.194||||0.434|TWO_SIDED|95.0|0.766|1.861|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 3 mg and in placebo|||1.861|0.766|0.434
73973575|NCT01474122|147490184|SUPERIORITY_OR_OTHER_LEGACY||NB-2 estimate of new DUs per patient|1.208||||0.407|TWO_SIDED|95.0|0.773|1.886|||NB-2||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 10 mg and in placebo|||1.886|0.773|0.407
73866853|NCT01192828|147278881|OTHER|Descriptive analysis||||||0.541|||||||Spearman's rank correlation|||Null hypothesis assumed|Spearman's rank correlation rho is 0.179, with p value 0.541, N is 14|||.541
73938848|NCT01654549|147410201|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||||||0.78
73973576|NCT01474122|147490185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.831||||0.5668|TWO_SIDED|95.0|0.442|1.564|||Chi-squared|||||1.564|0.442|0.5668
73938849|NCT01654549|147410201|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Paired t-test|||||||<0.01
73938850|NCT01654549|147410201|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Paired t-test|||||||<0.01
73938851|NCT01654549|147410201|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
73938852|NCT01043432|147410208|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Regression, Linear|||Linear regressions were utilized to model the outcomes of interest as a function of SA, TBI group, and the interaction between the two groups.||||>.05
73938853|NCT01869491|147410228|SUPERIORITY||Mean Difference (Final Values)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.31|-0.11|||Mixed Models Analysis|||||-0.11|-0.31|<0.0001
73973577|NCT01474122|147490185|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.789||||0.4624|TWO_SIDED|95.0|0.42|1.484|||Chi-squared|||||1.484|0.420|0.4624
73938854|NCT01869491|147410229|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0004|TWO_SIDED|95.0|-0.29|-0.08|||Mixed Models Analysis|||||-0.08|-0.29|0.0004
73938855|NCT01869491|147410230|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.0001|TWO_SIDED|95.0|-0.32|-0.1|||Mixed Models Analysis|||||-0.10|-0.32|0.0001
73938856|NCT01869491|147410231|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.0004|TWO_SIDED|95.0|-0.32|-0.09|||Mixed Models Analysis|||||-0.09|-0.32|0.0004
73973578|NCT01474122|147490186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.216||||0.6117|TWO_SIDED|95.0|0.572|2.582|||Chi-squared|||||2.582|0.572|0.6117
73973579|NCT01474122|147490186|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.048||||0.9047|TWO_SIDED|95.0|0.485|2.264|||Chi-squared|||||2.264|0.485|0.9047
73973580|NCT01474122|147490187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.347|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.347
73866854|NCT01192828|147278883|OTHER|Descriptive analysis||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed||||0.014
73866855|NCT01192828|147278884|OTHER|Descriptive analysis||||||0.012|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed||||0.012
73866856|NCT01192828|147278885|OTHER|Descriptive analysis.||||||0.16|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.160
73866857|NCT01192828|147278886|OTHER|Descriptive analysis||||||0.1|||||||t-test, 2 sided|||||||0.10
73938857|NCT01869491|147410232|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73938858|NCT01869491|147410233|SUPERIORITY|||||||0.0433|||||||Wilcoxon (Mann-Whitney)|||||||0.0433
73938859|NCT01869491|147410234|SUPERIORITY|||||||0.0503|||||||Wilcoxon (Mann-Whitney)|||||||0.0503
73938860|NCT04009291|147410235|SUPERIORITY||||||=|0.2635|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.2635
73938861|NCT04009291|147410235|SUPERIORITY||||||=|0.6999|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.6999
73938862|NCT04009291|147410235|SUPERIORITY||||||=|0.1394|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.1394
73938863|NCT04009291|147410236|SUPERIORITY||||||=|0.1281|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.1281
73938864|NCT04009291|147410236|SUPERIORITY||||||>|0.9999|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||> 0.9999
73938865|NCT04009291|147410236|SUPERIORITY||||||=|0.0604|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.0604
73938866|NCT00567242|147410292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2801|STANDARD_ERROR_OF_MEAN|0.1077|<|0.05|ONE_SIDED|95.0||-0.0709|||t-test, 1 sided|||"H1: The Intention Group will show a significant rightward shift in lateral frontal laterality from pre-treatment to post-treatment.~H0: The Intention Group will show no shift in lateral frontal laterality from pre-treatment to post-treatment.~Since this is a repeated measures t test, the data are presented as the mean and standard deviation for for the post-treatment laterality index minus the pre-treatment laterality index."||-0.0709||<.05
73938867|NCT00567242|147410292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1832|STANDARD_ERROR_OF_MEAN|0.2768|<|0.05|ONE_SIDED|95.0||0.3546|||t-test, 1 sided|||"H1: The Control Group will show a significant rightward shift in lateral frontal lateral indices from pre-treatment to post-treatment.~H0: The Control group will show no shift in lateral frontal laterality indices from pre-treatment to post-treatment.~Since the analysis to test these hypotheses is a repeated-measures t-test, the mean and standard deviation are given for post-treatment laterality index minus pre-treatment laterality index."||0.3546||<.05
73973581|NCT01474122|147490187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.165|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.165
73973582|NCT01474122|147490188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.339|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.339
73973583|NCT01474122|147490188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.312|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.312
73973584|NCT01474122|147490189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.319|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.319
73973585|NCT01474122|147490189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.221|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.221
73973586|NCT04214834|147490219|SUPERIORITY||Mean Difference (Final Values)|2.96|||<|0.001|TWO_SIDED|95.0|1.7|4.29|||Mixed Models Analysis||Given that the model was on the log scale, mean difference and 95% confidence interval were derived from 1,000 bootstrap resamples.|A logarithmic transformation was applied to the outcome, centers were added as random effects to account for variation between them.||4.29|1.70|<0.001
73938868|NCT00567242|147410293|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.88|<|0.05|ONE_SIDED|95.0|-1.81||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|||-1.81|<.05
73938869|NCT00567242|147410294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|ONE_SIDED|95.0|0.26||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|||0.26|<.05
73938870|NCT01022762|147410302|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be shown if the upper limit of the 95% confidence interval was less than 0.4%. This corresponds to a one-sided test with a significance level of 2.5% of the hypothesis.|Mean Difference (Net)|0.014|STANDARD_ERROR_OF_MEAN|0.066||||95.0|-0.115|0.143||The p-value corresponds to one-sided hypotheses of superiority with a significance level of 2.5%.|ANCOVA|ANCOVA model was with treatment, centre as explanatory variables and baseline HbA1c value as covariate.|If non-inferiority of repaglinide alone was shown, a test for superiority would be performed based on FAS. Superiority of repaglinide alone over gliclazide alone would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.|H0: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment \>= 0.4%. H1: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment \< 0.4%. Sample size was calculated to achieve a power of at least 85%, assuming an equal change in HbA1c and a common standard deviation of 1.2%.||0.143|-0.115|
73938871|NCT01302119|147410313|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73938872|NCT01302119|147410314|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73938873|NCT01302119|147410315|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73938874|NCT01302119|147410316|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73938875|NCT01055769|147410320|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|97.81|||||TWO_SIDED|90.0|93.11|102.75||||||Natural log transformed AUClast of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.75|93.11|
73938876|NCT01055769|147410321|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|113.67|||||TWO_SIDED|90.0|105.26|122.75||||||Natural log transformed Cmax of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||122.75|105.26|
73938877|NCT01055769|147410322|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric means ratio|97.65|||||TWO_SIDED|90.0|92.92|102.63||||||Natural log transformed AUCinf of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.63|92.92|
73938878|NCT02235493|147410325|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED|||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in MPOMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total MPOMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median MPOMA-G score used in the analyses.||||0.0625
73957881|NCT02263508|147451287|OTHER||Difference|0.19|STANDARD_ERROR_OF_MEAN|0.95||0.84|TWO_SIDED|95.0|-1.67|2.05|||Mixed Model for Repeated Measures|||Mixed Model for Repeated Measures include the fixed and categorical effects of treatment, visit and treatment-by-visit interaction, the fixed and continuous covariates of baseline HRQL score, randomization stratification factors (stage of disease and prior BRAF inhibitor therapy per IVRS) and baseline PD-L1 status (positive and not positive). Random subject effect was modeled using within subject-error correlation structure.||2.05|-1.67|0.84
73957882|NCT00531518|147451289|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED|||||The final analysis included adjstment for site and baseline sum psychotic symptom score.|Mixed Models Analysis|||The analysis used regression discontinuity methods, in which the baseline sum scores were adjusted and centered to an equalize control and experimental conditions.||||.0034
73957883|NCT03265210|147451290|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.39|TWO_SIDED|95.0|-4.95|1.95|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Baseline||1.95|-4.95|0.39
73957884|NCT03265210|147451290|SUPERIORITY||Mean Difference (Final Values)|-3.79||||0.03|TWO_SIDED|95.0|-7.19|-0.39|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|6 weeks||-0.39|-7.19|0.03
73957885|NCT03265210|147451290|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.42|TWO_SIDED|95.0|-5.38|2.26|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|9 weeks||2.26|-5.38|0.42
73957886|NCT03265210|147451290|SUPERIORITY||Mean Difference (Final Values)|-3.37||||0.07|TWO_SIDED|95.0|-7.02|0.28|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|12 weeks||0.28|-7.02|0.07
73957887|NCT03265210|147451291|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.17|TWO_SIDED|95.0|-1.81|0.33|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, Baseline||0.33|-1.81|0.17
73957888|NCT03265210|147451291|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.25|TWO_SIDED|95.0|-1.68|0.44|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 6 weeks||0.44|-1.68|0.25
73938879|NCT02235493|147410326|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in POMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total POMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median POMA-G score used in the analyses.||||0.1250
73938880|NCT02474927|147410383|OTHER|Descriptive (Pre-Post)||||||0.36|||||||Wilcoxon Signed Rank|||||||0.36
73938881|NCT02474927|147410384|OTHER|Descriptive (pre-post)||||||0.16|||||||Wilcoxon Signed Rank|||||||0.16
73938882|NCT00866840|147410394|OTHER|||||||||||||||||No objective responses were seen in the first phase and accrual was stopped.|No objective responses were seen in the first phase and accrual was stopped.|||
73938883|NCT02625623|147410397|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.8078|TWO_SIDED|95.0|0.88|1.41|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||1.41|0.88|0.8078
73938884|NCT02625623|147410398|SUPERIORITY||Hazard Ratio (HR)|1.73||||1|TWO_SIDED|95.0|1.36|2.21|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||2.21|1.36|1.0000
73938885|NCT02625623|147410400|SUPERIORITY||Odds Ratio (OR)|0.709||||0.8764|||||||Cochran-Mantel-Haenszel|The treatment arms were compared by 1-sided CMH test. The stratification factor was region (Asia versus non Asia).||||||0.8764
73938886|NCT01316926|147410405|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.9204|||||TWO_SIDED|90.0|0.8556|0.99|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.|||0.9900|0.8556|
73938887|NCT01316926|147410406|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.941|||||TWO_SIDED|90.0|0.846|1.0467|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.|||1.0467|0.8460|
73938888|NCT01316926|147410407|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.9333|||||TWO_SIDED|90.0|0.8502|1.0246|||||Coefficient Variation (intra-individual). The ratios between the geometric means of the test and reference formulations was calculated.|||1.0246|0.8502|
73938889|NCT02352948|147410416|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.42|0.93|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||0.93|0.42|
73938890|NCT02352948|147410416|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.109|TWO_SIDED|95.0|0.61|1.05|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||1.05|0.61|0.109
73938891|NCT02352948|147410417|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.49|1.04|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||1.04|0.49|
73938892|NCT02352948|147410417|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.056|TWO_SIDED|95.0|0.59|1.01|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||1.01|0.59|0.056
73938893|NCT02352948|147410418|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.885|TWO_SIDED|95.0|0.74|1.3|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.30|0.74|0.885
73938894|NCT02352948|147410418|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.153|TWO_SIDED|95.0|0.56|1.11|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||1.11|0.56|0.153
73938895|NCT02352948|147410419|SUPERIORITY|||||||0.063||||||The z-test statistic is the ratio of log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by square root of the variance.|z-test|The variance is estimated using the delta method and Greenwood's formula.||For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||||0.063
73957889|NCT03265210|147451291|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.09|TWO_SIDED|95.0|-2.29|0.17|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 9 weeks||0.17|-2.29|0.09
73938896|NCT02352948|147410420|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.282|TWO_SIDED|95.0|0.68|1.12|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.12|0.68|0.282
73938897|NCT02352948|147410420|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.011|TWO_SIDED|95.0|0.49|0.92|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||0.92|0.49|0.011
73938898|NCT02352948|147410421|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Odds Ratio (OR)|3.87|||||TWO_SIDED|95.0|1.61|10.1|||||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||10.10|1.61|
73938899|NCT02352948|147410421|SUPERIORITY||Odds Ratio (OR)|2.43||||0.037|TWO_SIDED|95.0|1.1|5.94|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||5.94|1.10|0.037
73938900|NCT02352948|147410421|SUPERIORITY||Odds Ratio (OR)|0.97||||0.923|TWO_SIDED|95.0|0.51|1.89|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.89|0.51|0.923
74088966|NCT02985879|147731164|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|13.54|=|0.597|TWO_SIDED|95.0|-33.86|19.53|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||19.53|-33.86|=0.597
73938901|NCT02352948|147410421|SUPERIORITY||Odds Ratio (OR)|2.46||||0.109|TWO_SIDED|95.0|0.91|8.61|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||8.61|0.91|0.109
73938902|NCT02352948|147410425|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.002|TWO_SIDED|95.0|0.49|0.85|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||0.85|0.49|0.002
73938903|NCT01680328|147410426|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.1||||||95.0|-2.9|2.8||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||2.8|-2.9|
73938904|NCT01680328|147410426|SUPERIORITY_OR_OTHER||Least Squares Mean|3.5||||||95.0|0.4|6.6||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.6|0.4|
73938905|NCT01680328|147410426|SUPERIORITY_OR_OTHER||Least Squares Mean|7.2||||||95.0|4.6|9.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||9.7|4.6|
73938906|NCT01680328|147410426|SUPERIORITY_OR_OTHER||Least Squares Mean|3.6||||||95.0|0.4|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.7|0.4|
73973587|NCT03884101|147490229|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5550121|TWO_SIDED|95.0|0.83|1.24|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.24|0.83|0.5550121
74088967|NCT02985879|147731164|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|13.56|=|0.642|TWO_SIDED|95.0|-33.04|20.42|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||20.42|-33.04|=0.642
73866858|NCT00590577|147278887|SUPERIORITY_OR_OTHER||Difference in least-squares means|-9.8|STANDARD_ERROR_OF_MEAN|2.0|<|0.001||95.0|-13.71|-5.85||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-5.85|-13.71|<0.001
73866859|NCT00590577|147278887|SUPERIORITY_OR_OTHER||Difference in least-squares means|-8.7|STANDARD_ERROR_OF_MEAN|2.0|<|0.001||95.0|-12.62|-4.78||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-4.78|-12.62|<0.001
73866860|NCT00590577|147278887|SUPERIORITY_OR_OTHER||Difference in least-squares means|-5.1|STANDARD_ERROR_OF_MEAN|2.01||0.034||95.0|-9.01|-1.1||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-1.10|-9.01|0.034
73866861|NCT00590577|147278888|SUPERIORITY_OR_OTHER||Difference in least-squares means|6.2|STANDARD_ERROR_OF_MEAN|1.49|<|0.001||95.0|3.26|9.12||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||9.12|3.26|<0.001
73938907|NCT01680328|147410426|SUPERIORITY_OR_OTHER||Least Squares Mean|7.2||||||95.0|4.4|10.0||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||10.0|4.4|
73938908|NCT01680328|147410426|SUPERIORITY_OR_OTHER||Least Squares Mean|3.7||||||95.0|0.6|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.7|0.6|
73938909|NCT01680328|147410426|SUPERIORITY_OR_OTHER||Least Squares Mean|0.4||||||95.0|-2.1|2.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.||2.9|-2.1|
73938910|NCT01680328|147410426|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.4||||||95.0|-2.7|1.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.||1.9|-2.7|
73973588|NCT03884101|147490230|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1792058|TWO_SIDED|95.0|0.77|1.1|||Log Rank|One-sided p-value based on log-rank test and stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||1.10|0.77|0.1792058
73973589|NCT03884101|147490231|NON_INFERIORITY|The null hypothesis for the non-inferiority test was that the hazard ratio was equal to 1.1.|Hazard Ratio (HR)|1.02||||0.2459875|TWO_SIDED|95.0|0.83|1.26|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.26|0.83|0.2459875
73973590|NCT03884101|147490231|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.5875597|TWO_SIDED|95.0|0.83|1.26|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.26|0.83|0.5875597
73973591|NCT03884101|147490232|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21552|TWO_SIDED|95.0|0.77|1.12|||Log Rank|One-sided p-value based on log-rank test and stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||1.12|0.77|0.21552
74030909|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.0301|TWO_SIDED|95.0|0.1|1.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.91|0.10|0.0301
74030910|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.0416|TWO_SIDED|95.0|0.02|0.89||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||0.89|0.02|0.0416
73938911|NCT01680328|147410426|SUPERIORITY_OR_OTHER||Least Squares Mean|9.0||||||95.0|6.7|11.3||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. The mean difference in injection pain on a VAS (mm) between the thighs and abdomen was calculated as the least square mean estimate of the mean difference in injection pain on a VAS (mm) between the thighs and abdomen.||11.3|6.7|
73938912|NCT01680328|147410427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.5|1.4|||Odds ratio (OR)|||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.4|0.5|
73938913|NCT01680328|147410427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||||95.0|1.2|3.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||3.5|1.2|
73938914|NCT01680328|147410427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||||95.0|1.4|3.0||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||3.0|1.4|
73938915|NCT01680328|147410427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|1.4|4.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||4.8|1.4|
73957890|NCT03265210|147451291|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.05|TWO_SIDED|95.0|-2.19|0.01|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 12 weeks||0.01|-2.19|0.05
73957891|NCT03265210|147451291|SUPERIORITY||Mean Difference (Final Values)|-3.19||||0.02|TWO_SIDED|95.0|-5.9|-0.48|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, Baseline||-0.48|-5.90|0.02
73957892|NCT03265210|147451291|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.003|TWO_SIDED|95.0|-7.06|-1.54|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 6 weeks||-1.54|-7.06|0.003
73957893|NCT03265210|147451291|SUPERIORITY||Mean Difference (Final Values)|-5.95||||0.0001|TWO_SIDED|95.0|-8.85|-3.05|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 9 weeks||-3.05|-8.85|0.0001
73957894|NCT03265210|147451291|SUPERIORITY||Mean Difference (Final Values)|-4.35||||0.007|TWO_SIDED|95.0|-7.46|-1.24|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 12 weeks||-1.24|-7.46|0.007
73957895|NCT03265210|147451292|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.0003|TWO_SIDED|95.0|0.53|1.69|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1||1.69|0.53|0.0003
73957896|NCT03265210|147451292|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.001|TWO_SIDED|95.0|0.21|0.83|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2||0.83|0.21|0.001
73957897|NCT03265210|147451292|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.002|TWO_SIDED|95.0|0.36|1.56|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 3||1.56|0.36|0.002
73957898|NCT02281318|147451302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|||<|0.001|TWO_SIDED|95.0|-10.5|-4.9|||Mixed model repeated measures analysis|||||-4.9|-10.5|<0.001
73957899|NCT02281318|147451303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.0||||0.001|TWO_SIDED|95.0|47.0|192.0|||Mixed model repeated measures analysis|||||192|47|0.001
73957900|NCT02281318|147451304|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23|||<|0.001|TWO_SIDED|95.0|1.55|3.22|||Regression, Logistic|||||3.22|1.55|<0.001
73957901|NCT02281318|147451305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||Mixed model repeated measures analysis|||||-0.22|-0.58|<0.001
73957902|NCT00812877|147451306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.35||||0.046|TWO_SIDED|95.0|1.19|4.66||A clustered permutation test with 10,000 random permutations based on the log rank test statistic was used for the primary treatment comparison to account for censoring and to ensure proper test size given the number of practices.|Log Rank||A confirmatory analysis, adjusted for patient, dentist, and tooth characteristics, and follow-up time, was performed using marginal proportional hazards regression with robust standard error estimates accounting for clustering by practice.|||4.66|1.19|.046
73938916|NCT01680328|147410427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|1.4|4.6||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||4.6|1.4|
73938917|NCT01680328|147410427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.7|1.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.5|0.7|
73938918|NCT01680328|147410428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.7|1.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.8|0.7|
73938919|NCT01680328|147410428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||||95.0|0.6|1.2||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.2|0.6|
73938920|NCT01680328|147410429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7||||||95.0|2.4|5.5|||Odds ratio (OR)|||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain in the thighs - i.e. a worse condition.||5.5|2.4|
73938921|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.6|
73938922|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.4||||||95.0|-0.8|1.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.6|-0.8|
73938923|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.9||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.1|-0.4|
73938924|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.7|-0.8|
73938925|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.7|-0.8|
73938926|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.7|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.7|
73957903|NCT00434018|147451440|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
73957904|NCT00414648|147451455|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The model included the time since enrollment, the treatment assignment, and the interaction between time and treatment.|Regression, Linear|Mixed model with the use of the Kenward-Roger correction without imputation of missing data.||FEV1 slope||||<0.001
73957905|NCT00414648|147451456|OTHER|||||||0.441|||||||Chi-squared|||||||.441
73957906|NCT00414648|147451457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Linear|GLM adjusted for baseline||||||0.001
73957907|NCT00414648|147451458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|GLM adjusted for baseline||||||0.17
73957908|NCT00414648|147451459|SUPERIORITY|||||||0.34|||||||Regression, Linear|GLM adjusted for baseline||||||0.34
73957909|NCT00414648|147451460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|||||||Regression, Linear|GLM adjusted for baseline||||||0.88
73957910|NCT00414648|147451461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Linear|GLM adjusted for baseline||||||0.001
73957911|NCT00952718|147451462|SUPERIORITY|||||||0.005||||||p-value for MIP was adjusted by linear regression model.|Regression, Linear|||||||0.005
73957912|NCT00952718|147451462|SUPERIORITY|||||||0.038||||||adjusted p for MEP by linear regression|Regression, Linear|||||||0.038
73957913|NCT00952718|147451463|SUPERIORITY|||||||0.063|||||||Regression, Linear|||||||0.063
73957914|NCT00952718|147451464|SUPERIORITY|||||||0.269|||||||Regression, Linear|||||||0.269
73957915|NCT04173572|147451465|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-13.47|STANDARD_DEVIATION|48.09|||TWO_SIDED|||||||||Posttreatment - Baseline: 10 participants analyzed (had data at both time points)||||
73957916|NCT04173572|147451465|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.7|STANDARD_DEVIATION|52.743|||TWO_SIDED|||||||||Posttreatment - Baseline: 9 participants analyzed (had data at both time points)||||
73957917|NCT04173572|147451466|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|22.133|STANDARD_DEVIATION|79.938|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
73938927|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.9||||||95.0|-0.3|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.1|-0.3|
73938928|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.8||||||95.0|-0.4|2.0||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.0|-0.4|
73938929|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.1||||||95.0|-0.1|2.3||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.3|-0.1|
73938930|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|2.3||||||95.0|1.0|3.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||3.5|1.0|
73938931|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.4||||||95.0|0.2|2.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.6|0.2|
73938932|NCT01680328|147410430|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.6|
73938933|NCT01680328|147410431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.3||||||95.0|-0.9|1.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||1.5|-0.9|
73938934|NCT01680328|147410431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.8||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.1|-0.4|
73938935|NCT01680328|147410431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.6||||||95.0|0.3|2.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.8|0.3|
73938936|NCT01680328|147410431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.9||||||95.0|3.7|6.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||6.1|3.7|
73938937|NCT01680328|147410431|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.7||||||95.0|0.5|2.9||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.9|0.5|
73938938|NCT04951336|147410466|SUPERIORITY||ratio of frequencies|0.04||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
73938939|NCT04951336|147410467|SUPERIORITY||ratio of frequencies|0.06||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
73938940|NCT04951336|147410468|SUPERIORITY||ratio of frequencies|0.7||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
73938941|NCT04951336|147410469|SUPERIORITY||ratio of frequencies|1.68||||0.359|TWO_SIDED||||||Chi-squared, Corrected|||||||0.359
73938942|NCT04951336|147410470|SUPERIORITY|age was included as a covariate||||||0.002||||||Differences were considered statistically significant for p-values \<0.05.|Mixed Models Analysis|F(2,150)=6.374. The analysis was repeated using log-transformed values and the resultant p value was also \< 0.05||"The LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data."||||0.002
73957918|NCT04173572|147451466|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|7.8|STANDARD_DEVIATION|99.645|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
73957919|NCT04173572|147451467|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|13.642|STANDARD_DEVIATION|4213.837|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
73957920|NCT04173572|147451467|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-483.4|STANDARD_DEVIATION|2497.312|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
73957921|NCT04173572|147451468|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.229|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
73957922|NCT04173572|147451468|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.563|STANDARD_DEVIATION|8.695|||TWO_SIDED|||||||||Posttreatment - Baseline: 16 participants analyzed (had data at both time points)||||
73957923|NCT04173572|147451469|OTHER|Single group mean difference between baseline and post-treatment assessments.|Median Difference (Net)|-9.333|STANDARD_DEVIATION|14.166|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
73957924|NCT04173572|147451469|OTHER|Single group mean difference between baseline and post-treatment assessments.|Median Difference (Net)|0.625|STANDARD_DEVIATION|9.664|||TWO_SIDED|||||||||Posttreatment - Baseline: 16 participants analyzed (had data at both time points)||||
73938943|NCT04951336|147410471|SUPERIORITY|age was included as a covariate||||||0.002||||||p \< 0.05.|Mixed Models Analysis|F(2,157)=4.286. The analysis was repeated using log-transformed values and the resultant p value was also \< 0.05||"LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data."||||0.002
73938944|NCT04951336|147410472|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|F(8,325)=1.898. Age was included as a covariate in this analysis.||LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)||||0.060
73938945|NCT04951336|147410473|SUPERIORITY|LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)||||||0.326|||||||Mixed Models Analysis|F(8,309)=1.156. Age was included as a covariate in this analysis.||||||0.326
73866862|NCT00590577|147278888|SUPERIORITY_OR_OTHER||Difference in least-squares means|4.4|STANDARD_ERROR_OF_MEAN|1.5||0.007||95.0|1.43|7.31||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||7.31|1.43|0.007
73938983|NCT00127608|147410501|NON_INFERIORITY|The mean viral load between samples stored in liquid and samples stored dry was compared.|Geometric Mean Ratio|0.33|||<|0.0001|||||||ANOVA|Tukey adjustments were made for all 2 by 2 comparisons.|The Geometric Mean Ratio of the viral load was calculated for dry over liquid storage condition.|||||<0.0001
73938984|NCT00127608|147410502|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Papule swab minus Vesicle fluid)|Mean Difference (Final Values)|-0.4451||||0.0038||95.0|-0.769|-0.1213|||ANOVA|Tukey adjustments were made for the comparison.||||-0.1213|-0.7690|0.0038
74030911|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.0333|TWO_SIDED|95.0|0.04|0.88||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||0.88|0.04|0.0333
73938985|NCT00127608|147410502|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Papule swab minus Vesicle swab)|Median Difference (Final Values)|-0.432||||0.006|TWO_SIDED|95.0|-0.7605|-0.1035|||ANOVA|Tukey adjustments were made for the comparison.||||-0.1035|-0.7605|0.0060
73938986|NCT00127608|147410502|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Vesicle fluid minus Vesicle swab)|Mean Difference (Final Values)|0.00132||||0.9952|TWO_SIDED|95.0|-0.3171|0.3435|||ANOVA|Tukey adjustments were made for the comparison.||||0.3435|-0.3171|0.9952
73938987|NCT00127608|147410502|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Papule swab over Vesicle fluid)|Geometric mean ratio|0.36|||||TWO_SIDED|95.0|0.17|0.76|||ANOVA|||Geometric mean ratio of viral load (Papule swab over Vesicle fluid)||0.76|0.17|
73938988|NCT00127608|147410502|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Papule swab over Vesicle swab)|Geometric mean Ratio|0.37|||||TWO_SIDED|95.0|0.17|0.79|||ANOVA|||Geometric mean ratio of viral load (Papule swab over Vesicle swab)||0.79|0.17|
73938989|NCT00127608|147410502|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)|Geometric mean Ratio|1.0|||||TWO_SIDED|95.0|0.48|2.21|||ANOVA|||Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)||2.21|0.48|
73938990|NCT01329029|147410505|SUPERIORITY_OR_OTHER||Rate ratio|0.868|STANDARD_ERROR_OF_MEAN|0.0633||0.0529|TWO_SIDED|95.0|0.753|1.002||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|||1.002|0.753|0.0529
73938991|NCT01329029|147410506|SUPERIORITY_OR_OTHER||LS Mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.0089|<|0.0001|TWO_SIDED|95.0|0.038|0.073|||ANCOVA|Analysis of Covariance (ANCOVA) including treatment by time interaction.||||0.073|0.038|<0.0001
73938992|NCT01329029|147410507|SUPERIORITY_OR_OTHER||Rate ratio|0.757|STANDARD_ERROR_OF_MEAN|0.0889||0.0175|TWO_SIDED|95.0|0.601|0.952|||Generalized Linear Regression|Analyzed using a negative binomial regression model excluding a correction for overdispersion.|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|||0.952|0.601|0.0175
73938993|NCT01329029|147410508|SUPERIORITY_OR_OTHER||Rate ratio|0.914|STANDARD_ERROR_OF_MEAN|0.0771||0.2875|TWO_SIDED|95.0|0.775|1.078||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Moderate COPD Exacerbations||1.078|0.775|0.2875
73938994|NCT01329029|147410508|SUPERIORITY_OR_OTHER||Rate Ratio|0.794|STANDARD_ERROR_OF_MEAN|0.0654||0.005|TWO_SIDED|95.0|0.675|0.933||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Mild, Moderate or Severe COPD Exacerbations||0.933|0.675|0.0050
73938995|NCT01329029|147410508|SUPERIORITY_OR_OTHER||Rate ratio|0.854|STANDARD_ERROR_OF_MEAN|0.0605||0.0262|TWO_SIDED|95.0|0.744|0.982||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|COPD Exacerbations treated with Glucocorticosteroids and/or Antibiotics||0.982|0.744|0.0262
73938996|NCT01329029|147410508|SUPERIORITY_OR_OTHER||Rate ratio|0.837|STANDARD_ERROR_OF_MEAN|0.0528||0.0047|TWO_SIDED|95.0|0.739|0.947||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Moderate or Severe COPD Exacerbations and/or treated with Antibiotics||0.947|0.739|0.0047
73957925|NCT04173572|147451470|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.392|STANDARD_DEVIATION|1.148|||TWO_SIDED|||||||||Posttreatment - Baseline: 13 participants analyzed (had data at both time points)||||
74030912|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.0693|TWO_SIDED|95.0|-0.05|1.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.44|-0.05|0.0693
74030913|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.0187|TWO_SIDED|95.0|0.14|1.56||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.56|0.14|0.0187
73866863|NCT00590577|147278888|SUPERIORITY_OR_OTHER||Difference in least-squares means|1.0|STANDARD_ERROR_OF_MEAN|1.5||0.509||95.0|-1.96|3.95||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||3.95|-1.96|0.509
73938997|NCT01329029|147410508|SUPERIORITY_OR_OTHER||Rate ratio|0.761|STANDARD_ERROR_OF_MEAN|0.0899||0.0209|TWO_SIDED|95.0|0.604|0.96||Level of significance: 5% 2-sided.|Generalized Linear Regression|Negative binomial regression model (estimates of exacerbation rates)|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Leading to Hospitalisation||0.960|0.604|0.0209
73938998|NCT01329029|147410510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917|STANDARD_ERROR_OF_MEAN|0.0549||0.1461|TWO_SIDED|95.0|0.815|1.031||Level of significance: 5% 2-sided.|Cox proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.031|0.815|0.1461
73973592|NCT03884101|147490233|OTHER||Difference in Percentage|-4.2||||0.8569|TWO_SIDED|95.0|-11.9|3.5|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||3.5|-11.9|0.8569
73973593|NCT03884101|147490234|OTHER||Difference in Percentage|0.0||||0.4999|TWO_SIDED|95.0|-6.7|6.7|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||6.7|-6.7|0.4999
73973594|NCT03884101|147490235|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors ECOG performance status, and prior chemotherapy and/or chemoradiation.|Difference in Least Square Means|-3.77||||0.0302|TWO_SIDED|95.0|-7.17|-0.36|||cLDA model|||||-0.36|-7.17|0.0302
73973595|NCT03884101|147490236|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Difference in Least Square Means|-2.29||||0.1355|TWO_SIDED|95.0|-5.31|0.72|||cLDA model|||||0.72|-5.31|0.1355
73973596|NCT03370913|147490241|SUPERIORITY||% Reduction from Baseline|-77.0|||<|0.0001|TWO_SIDED|||||P-values were for 2-sided test against 0.|t-test, 2 sided|Superiority was tested by1-sample t-test to test null hypothesis that change is \>=0. Only negative changes represent efficacy.|77% reduction|Change from baseline in the ABR for all bleeds (post-baseline EEP value - baseline value)||||<0.0001
73973597|NCT05061017|147490254|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.0000
74030914|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.5765|TWO_SIDED|95.0|-1.34|0.75||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.75|-1.34|0.5765
73938999|NCT01329029|147410511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|STANDARD_ERROR_OF_MEAN|0.0842||0.027|TWO_SIDED|95.0|0.641|0.974||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of \<1 represents a favourable outcome for the test treatment|||0.974|0.641|0.0270
73973598|NCT05061017|147490255|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.0000
73973599|NCT02938520|147490275|NON_INFERIORITY|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA \>=50 c/mL) can be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in failure rates between the two treatment arms (CAB - ABC/DTG/3TC) is less than 6%.|Adjusted difference in proportion|-0.4|||||TWO_SIDED|95.0|-2.8|2.1|||||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (\<100,000 \>=100,000 c/mL)|2.1|-2.8|
73973600|NCT02938520|147490276|NON_INFERIORITY|Non-inferiority in the proportion of participants with HIV-1 RNA\<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - ABC/DTG/3TC) is more than -10%|Adjusted difference in proportion|0.4|||||TWO_SIDED|95.0|-3.7|4.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (\<100,000 \>=100,000 c/mL)|||4.5|-3.7|
73973601|NCT02938520|147490329|OTHER||||||<|0.001||||||Week 41/48 was compared with the 1st visit (Week 5) based on Wilcoxon signed-rank test, respectively. p-values are derived for 'Acceptance' only and not adjusted for multiple testing.|Wilcoxon (Mann-Whitney)|||||||<0.001
73973602|NCT02938520|147490331|OTHER||Adjusted difference|1.2||||0.307|TWO_SIDED|95.0|-1.1|3.6|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.6|-1.1|0.307
74030915|NCT00570739|147615619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.4762|TWO_SIDED|95.0|-1.35|0.63||P-Value is for the LS Mean Difference between treatment group|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.63|-1.35|0.4762
74030916|NCT00570739|147615620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21||||0.0652|TWO_SIDED|95.0|-0.14|4.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||4.57|-0.14|0.0652
73939000|NCT01329029|147410512|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.749|STANDARD_ERROR_OF_MEAN|0.1209||0.0731|TWO_SIDED|95.0|0.546|1.027||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of \<1 represents a favourable outcome for the test treatment.|||1.027|0.546|0.0731
73939001|NCT01329029|147410513|SUPERIORITY_OR_OTHER||NNTB|9.0|||||TWO_SIDED|95.0|4.0|31.0||||||||31|4|
73939002|NCT01329029|147410516|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.092|STANDARD_ERROR_OF_MEAN|0.0159|<|0.0001|TWO_SIDED|95.0|0.061|0.124||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and restricted maximum likelihood (REML).||||0.124|0.061|<0.0001
73939003|NCT01329029|147410517|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.025|STANDARD_ERROR_OF_MEAN|0.0062|<|0.0001|TWO_SIDED|95.0|0.013|0.038||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.038|0.013|<0.0001
73939004|NCT01329029|147410518|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.094|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.069|0.12||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.120|0.069|<0.0001
73939005|NCT01329029|147410520|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.283|STANDARD_ERROR_OF_MEAN|0.0941||0.0027|TWO_SIDED|95.0|-0.467|-0.098||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.||||-0.098|-0.467|0.0027
73939006|NCT01329029|147410521|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0439||0.7392|TWO_SIDED|95.0|-0.101|0.071||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.||||0.071|-0.101|0.7392
73939007|NCT01329029|147410524|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.285|STANDARD_ERROR_OF_MEAN|0.2175||0.1909|TWO_SIDED|95.0|-0.711|0.142||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.142|-0.711|0.1909
73939008|NCT01329029|147410526|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.025|STANDARD_ERROR_OF_MEAN|0.3468||0.9414|TWO_SIDED|95.0|0.528|1.99||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.990|0.528|0.9414
74088968|NCT02985879|147731165|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.53|=|0.323|TWO_SIDED|95.0|-2.48|7.51|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||7.51|-2.48|=0.323
73939009|NCT01329029|147410527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078|STANDARD_ERROR_OF_MEAN|0.5765||0.8876|TWO_SIDED|95.0|0.378|3.075|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||3.075|0.378|0.8876
73939010|NCT01329029|147410528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.529|STANDARD_ERROR_OF_MEAN|0.1463|<|0.0001|TWO_SIDED|95.0|1.268|1.845|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.845|1.268|<0.0001
73939011|NCT01329029|147410529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695|STANDARD_ERROR_OF_MEAN|0.2691||0.3477|TWO_SIDED|95.0|0.326|1.484||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.484|0.326|0.3477
73939012|NCT01329029|147410531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.083|STANDARD_ERROR_OF_MEAN|0.3832||0.8208|TWO_SIDED|95.0|0.542|2.167||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||2.167|0.542|0.8208
73939013|NCT01329029|147410533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977|STANDARD_ERROR_OF_MEAN|0.0865||0.7943|TWO_SIDED|95.0|0.821|1.162||Level of significance: 5% 2-sided.|Cox-proportional hazards model|||||1.162|0.821|0.7943
73939014|NCT00857207|147410553|SUPERIORITY||Mean Difference (Final Values)|-3.95|STANDARD_ERROR_OF_MEAN|1.14||0.0004|TWO_SIDED|95.0|||||Regression, Linear|dependent variable: post-treatment outcome; independent variables:pre-treatment measurement and group indicator.||Linear regression of change of cTOL time to first move in GMT versus BHW group||||0.0004
73939015|NCT00857207|147410553|SUPERIORITY||Mean Difference (Final Values)|-2.92|STANDARD_DEVIATION|3.55||0.012|TWO_SIDED|95.0|||||t-test, 2 sided|||total time will significantly improve 10 weeks from post||||0.012
73939016|NCT00857207|147410553|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.04||0.98|TWO_SIDED|95.0|||||t-test, 2 sided|||Time to first move will significantly increase at 10 weeks from baseline to indicate better planning||||0.98
73939017|NCT00857207|147410554|SUPERIORITY||Mean Difference (Final Values)|2.64|STANDARD_DEVIATION|6.42||0.15|TWO_SIDED|95.0|||||t-test, 2 sided|||paired T-test, Behavioral Regulation Index will improve at week 10 from baseline||||0.15
73939018|NCT00857207|147410554|SUPERIORITY||Mean Difference (Final Values)|2.79|STANDARD_DEVIATION|8.4||0.24|TWO_SIDED|95.0|||||t-test, 2 sided|||paired t-test of Metacognitive Index, MI will improve at 10 weeks compared to baseline.||||0.24
73939019|NCT00857207|147410555|SUPERIORITY||Median Difference (Final Values)|0.03|STANDARD_DEVIATION|0.09||0.3|TWO_SIDED|95.0|||||t-test, 2 sided|||optimal moves will significantly increase at 10 weeks from baseline||||0.30
73939020|NCT01258608|147410558|OTHER||Hazard Ratio (HR)|1.192||||0.7382|ONE_SIDED|90.0||1.737||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.737||0.7382
73957926|NCT04173572|147451470|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.113|STANDARD_DEVIATION|1.401|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
73957927|NCT04173572|147451471|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.2|STANDARD_DEVIATION|20.11|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
73939021|NCT01258608|147410559|OTHER||Hazard Ratio (HR)|0.922||||0.3156|ONE_SIDED|90.0||1.288||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.288||0.3156
73939022|NCT01258608|147410560|OTHER||Hazard Ratio (HR)|1.007||||0.6121|ONE_SIDED|90.0||1.346||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.346||0.6121
73939023|NCT01258608|147410561|OTHER||Hazard Ratio (HR)|1.066||||0.6925|ONE_SIDED|90.0||1.43||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.430||0.6925
73939024|NCT01258608|147410562|OTHER||Hazard Ratio (HR)|0.909||||0.3088|ONE_SIDED|90.0||1.191||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.191||0.3088
73939025|NCT01258608|147410563|OTHER||Response rate difference|5.4||||0.5458|TWO_SIDED|95.0|-16.8|26.6||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||26.6|-16.8|0.5458
73939026|NCT01258608|147410564|OTHER||Response rate difference|6.7||||0.3479|TWO_SIDED|95.0|-13.4|26.2||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||26.2|-13.4|0.3479
73939027|NCT01258608|147410565|OTHER||Disease control rate difference|-20.7||||0.0198|TWO_SIDED|95.0|-40.8|1.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||1.8|-40.8|0.0198
73939028|NCT01258608|147410566|OTHER||Disease control rate difference|-5.8||||0.6558|TWO_SIDED|95.0|-25.4|13.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||13.8|-25.4|0.6558
73939029|NCT04098939|147410583|EQUIVALENCE|Bland-Altman plots|Bland-Altman plots|0.39|||<|0.05|TWO_SIDED|95.0|0.26|1.04||Analysis of Bland-Altman plots|Bland-Altman plots|Analysis of Bland-Altman plots|||Analysis of Bland-Altman plots|1.04|0.26|<0.05
73939030|NCT02943408|147410584|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||.90
73939031|NCT02943408|147410585|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||||||.99
73973603|NCT02938520|147490331|OTHER||Adjusted difference|0.9||||0.472|TWO_SIDED|95.0|-1.5|3.2|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.2|-1.5|0.472
73973604|NCT02938520|147490332|OTHER||Adjusted difference|1.8||||0.116|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.9|-0.4|0.116
73973605|NCT02938520|147490332|OTHER||Adjusted difference|0.1||||0.944|TWO_SIDED|95.0|-2.3|2.5|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.5|-2.3|0.944
73939032|NCT02943408|147410586|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||.56
73939033|NCT02943408|147410587|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||.85
73939034|NCT02943408|147410588|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||.43
73939035|NCT02943408|147410589|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||.82
73939036|NCT02943408|147410590|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||.50
73939037|NCT02943408|147410591|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||.56
73939038|NCT02943408|147410592|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||.92
73939039|NCT02943408|147410593|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|||||||.65
73939040|NCT02943408|147410594|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||.35
73939041|NCT01106833|147410596|SUPERIORITY|||||||0.63||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 6 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.63
73939042|NCT01106833|147410596|SUPERIORITY|||||||0.44||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 24 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.44
73939043|NCT01106833|147410597|SUPERIORITY|||||||0.205||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of overall survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.205
73939044|NCT01106833|147410598|SUPERIORITY|||||||0.141||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of progression-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.141
73939045|NCT01106833|147410599|SUPERIORITY|||||||0.775||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of failure-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.775
73866864|NCT00590577|147278889|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||<0.001
73866865|NCT00590577|147278889|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.005
73939046|NCT01106833|147410600|SUPERIORITY|||||||0.396||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without relapse was treated as a competing risk||The null hypothesis is that the rate of relapse during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.396
73939047|NCT01106833|147410601|SUPERIORITY|||||||0.219||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without initiation of secondary therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of initiation of secondary immunosuppressive therapy for chronic GVHD during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.219
73939048|NCT01106833|147410602|SUPERIORITY|||||||0.706||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without discontinuation of systemic immunosuppressive therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of discontinuation of systemic immunosuppressive therapy during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.706
73939049|NCT01106833|147410603|SUPERIORITY|||||||0.127||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.127
73939050|NCT01106833|147410603|SUPERIORITY|||||||0.562||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.562
73939051|NCT01106833|147410603|SUPERIORITY|||||||0.129||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.129
73939052|NCT01106833|147410604|SUPERIORITY|||||||0.586||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.586
73939053|NCT01106833|147410604|SUPERIORITY|||||||0.14||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.140
73939054|NCT01106833|147410605|SUPERIORITY|||||||0.582||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.582
73939055|NCT01106833|147410605|SUPERIORITY|||||||0.208||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.208
73939056|NCT01106833|147410605|SUPERIORITY|||||||0.431||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.431
73866866|NCT00590577|147278889|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.140
73866867|NCT00418574|147278899|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.099||||0.301|TWO_SIDED|95.0|0.919|1.315|||Regression, Cox|||||1.315|0.919|0.301
73939057|NCT01106833|147410606|SUPERIORITY|||||||0.147||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.147
73939058|NCT01106833|147410606|SUPERIORITY|||||||0.863||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.863
73866868|NCT02332291|147278933|SUPERIORITY||Odds Ratio, log|0.8642|STANDARD_ERROR_OF_MEAN|0.475||0.0689|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|||Statistical analyses utilized a logistic regression model with remission status (defined as final MADRS \<= 7) as the dependent variable. The independent variable of interest was treatment arm assignment, and the model included age, sex, and baseline depression severity by MADRS as covariates.||||0.0689
73939059|NCT01106833|147410607|SUPERIORITY|||||||0.62||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.620
73939060|NCT01106833|147410607|SUPERIORITY|||||||0.258||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.258
73939061|NCT01106833|147410607|SUPERIORITY|||||||0.036||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.036
73939062|NCT01106833|147410607|SUPERIORITY|||||||0.369||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.369
73939063|NCT01106833|147410608|SUPERIORITY|||||||0.45||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.450
73939064|NCT01106833|147410608|SUPERIORITY|||||||0.301||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.301
73939065|NCT01106833|147410608|SUPERIORITY|||||||0.75||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.750
73939066|NCT01106833|147410608|SUPERIORITY|||||||0.444||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.444
73939067|NCT01106833|147410609|SUPERIORITY|||||||0.238||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.238
73939068|NCT01106833|147410609|SUPERIORITY|||||||0.546||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.546
73939069|NCT01106833|147410609|SUPERIORITY|||||||0.756||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.756
73973606|NCT02938520|147490333|OTHER||Adjusted difference|-1.3||||0.552|TWO_SIDED|95.0|-5.7|3.0|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.0|-5.7|0.552
73939070|NCT01106833|147410609|SUPERIORITY|||||||0.554||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.554
73939071|NCT01106833|147410610|SUPERIORITY|||||||0.685||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.685
73939072|NCT01106833|147410610|SUPERIORITY|||||||0.105||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.105
73939073|NCT01106833|147410610|SUPERIORITY|||||||0.039||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.039
73939074|NCT01106833|147410610|SUPERIORITY|||||||0.278||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.278
73939075|NCT01106833|147410610|SUPERIORITY|||||||0.804||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.804
73939076|NCT01106833|147410611|SUPERIORITY|||||||0.631||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.631
73939077|NCT01106833|147410611|SUPERIORITY|||||||0.759||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.759
73939078|NCT01106833|147410611|SUPERIORITY|||||||0.391||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.391
74030917|NCT00570739|147615620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74||||0.0137|TWO_SIDED|95.0|0.57|4.92||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||4.92|0.57|0.0137
74030918|NCT00570739|147615620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.4726|TWO_SIDED|95.0|-0.2|0.09||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotien Particles||0.09|-0.20|0.4726
74030919|NCT00570739|147615620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.5715|TWO_SIDED|95.0|-0.17|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles||0.10|-0.17|0.5715
74030920|NCT00570739|147615620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.0083|TWO_SIDED|95.0|0.02|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.15|0.02|0.0083
74030921|NCT00570739|147615620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0022|TWO_SIDED|95.0|0.03|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.15|0.03|0.0022
74030922|NCT00570739|147615621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.0||||0.0036|TWO_SIDED|95.0|8.6|43.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||43.5|8.6|0.0036
74030923|NCT00570739|147615621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.2||||0.001|TWO_SIDED|95.0|11.2|43.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||43.3|11.2|0.0010
73939079|NCT01106833|147410611|SUPERIORITY|||||||0.222||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.222
73939080|NCT01106833|147410611|SUPERIORITY|||||||0.527||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.527
74030924|NCT00570739|147615622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.8||||0.0008|TWO_SIDED|95.0|12.5|47.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||47.0|12.5|0.0008
74030925|NCT00570739|147615622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.7||||0.0002|TWO_SIDED|95.0|14.9|46.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||46.6|14.9|0.0002
74030926|NCT00570739|147615623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0033|TWO_SIDED|95.0|0.9|4.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||4.3|0.9|0.0033
74030927|NCT00570739|147615623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.0008|TWO_SIDED|95.0|1.2|4.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.4|1.2|0.0008
74030928|NCT00570739|147615624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0035|TWO_SIDED|95.0|-0.44|-0.09||P-Value is for the LS mean difference between the treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||||-0.09|-0.44|0.0035
73939081|NCT01106833|147410612|SUPERIORITY|||||||0.763||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.763
73939082|NCT01106833|147410612|SUPERIORITY|||||||0.133||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.133
73939083|NCT01106833|147410612|SUPERIORITY|||||||0.953||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.953
73939084|NCT01106833|147410612|SUPERIORITY|||||||0.398||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.398
73939085|NCT01106833|147410612|SUPERIORITY|||||||0.309||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.309
73939086|NCT00886340|147410617|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||controlled for site, income, race/ethnicity|Mixed Models Analysis|||pilot test, used 20% of sample required for a full test of the hypothesis||||0.08
73939087|NCT02120027|147410671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986||||0.949|TWO_SIDED|95.0|0.64|1.53|||Cochran-Mantel-Haenszel|||||1.53|0.64|0.949
73939088|NCT02120027|147410672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.193|TWO_SIDED|95.0|0.88|1.86|||Cochran-Mantel-Haenszel|||||1.86|0.88|0.193
73939089|NCT02120027|147410673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||0.872|TWO_SIDED|95.0|0.7|1.53|||Cochran-Mantel-Haenszel|||||1.53|0.70|0.872
73939090|NCT02120027|147410674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.339||||0.272|TWO_SIDED|95.0|0.79|2.26|||Cochran-Mantel-Haenszel|||||2.26|0.79|0.272
73939091|NCT02120027|147410675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.153||||0.567|TWO_SIDED|95.0|0.73|1.81|||Cochran-Mantel-Haenszel|||||1.81|0.73|0.567
73939092|NCT01002872|147410676|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||||||0.037
73939093|NCT01002872|147410677|SUPERIORITY|||||||0.721|||||||t-test, 2 sided|||||||0.721
73939094|NCT01002872|147410678|SUPERIORITY|||||||0.897|||||||t-test, 2 sided|||||||0.897
73939095|NCT01002872|147410679|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
73939096|NCT01002872|147410680|SUPERIORITY|||||||0.416|||||||t-test, 2 sided|||||||0.416
73939097|NCT01002872|147410681|SUPERIORITY|||||||0.672|||||||t-test, 2 sided|||||||0.672
73939098|NCT01002872|147410682|SUPERIORITY|||||||0.955|||||||t-test, 2 sided|||||||0.955
73939099|NCT01002872|147410683|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73939100|NCT01002872|147410684|SUPERIORITY|||||||0.0066|||||||t-test, 2 sided|||||||0.0066
73939101|NCT00414817|147410685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018||||0.002|TWO_SIDED|95.0|0.006|0.03|||Regression, Linear|2-tailed p-value based on linear regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|Estimated adherence was approximately 2 percentage points higher for intervention group than for usual care group.|In all of our analyses we used duration of follow-up as a weighting variable to reflect the fact that our adherence measure becomes more accurate and reliable with longer follow-up. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above. Also, sensitivity analyses that included daily oral steroid users and those with fewer than 3 months of follow-up yielded similar results to those presented here.||.030|.006|.002
73939102|NCT00414817|147410686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.175|TWO_SIDED|95.0|-0.23|0.04|||Regression, Linear|2-tailed p-value adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline adherence.||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.||0.04|-0.23|0.175
73939103|NCT00414817|147410687|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.852|TWO_SIDED|95.0|0.96|1.06||2-tailed p-value based on overdispersed Poisson regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|overdispersed Poisson regression|||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.||1.06|0.96|0.852
73939104|NCT03035292|147410689|SUPERIORITY||||||<|0.05||||||This value of \<0.05 is the calculated p value where the a priori threshold for statistical significance is considered to be p=0.05.|McNemar|||Sample size was based on a cataract prevalence of 20% in the enriched population and a predicted difference of 15% sensitivity and specificity between tests.||||<0.05
73939105|NCT03035292|147410691|SUPERIORITY||||||<|0.05||||||The calculated p value was \<0.05. A priori threshold for statistical significance is p=0.05|Fisher Exact|||Evidence of superiority of intervention 2 over intervention 1 requires a significant difference in specificity of the intervention 1 and 2 between ethnicity groups.||||<0.05
73939106|NCT04162769|147410715|SUPERIORITY||Least square mean difference|-10.28|STANDARD_ERROR_OF_MEAN|6.605|=|0.1198|TWO_SIDED|95.0|-23.228|2.674|||ANCOVA|||Week 12||2.674|-23.228|=0.1198
73939107|NCT04162769|147410715|SUPERIORITY||Least square mean difference|-8.77|STANDARD_ERROR_OF_MEAN|6.515|=|0.1783|TWO_SIDED|95.0|-21.544|4.002|||ANCOVA|||Week 12||4.002|-21.544|=0.1783
73866869|NCT02332291|147278934|SUPERIORITY||Slope, fixed effect|-1.066|STANDARD_ERROR_OF_MEAN|0.264||0.0001|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|344 degrees of freedom||Statistical analyses utilized mixed model. MADRS score was the repeated measures dependent variable. Independent variables included time, age, sex, and treatment assignment. The primary variable of interest for this analysis was an interaction term between time and treatment assignment. A statistically significant interaction term would indicate that one treatment arm experienced a greater change in MADRS score over time than the other treatment arm.||||0.0001
73866870|NCT02332291|147278935|SUPERIORITY||Slope, fixed effects|-0.3117|STANDARD_ERROR_OF_MEAN|0.1566||0.0483|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|150 degrees of freedom||Statistical analyses utilized mixed models, with QIDS score being the repeated measures dependent variable. Independent variables included time, age, sex, and treatment assignment. The primary variable of interest was an interaction term between time and treatment assignment.||||0.0483
73939108|NCT04162769|147410716|SUPERIORITY||Response Rate Difference|-0.2|STANDARD_ERROR_OF_MEAN|9.34|=|0.9826|TWO_SIDED|95.0|-18.52|18.11|||Cochran-Mantel-Haenszel|||Week 12||18.11|-18.52|=0.9826
73939109|NCT04162769|147410716|SUPERIORITY||Response Rate Difference|13.0|STANDARD_ERROR_OF_MEAN|9.78|=|0.1891|TWO_SIDED|95.0|-6.12|32.21|||Cochran-Mantel-Haenszel|||Week 12||32.21|-6.12|=0.1891
73939110|NCT04162769|147410717|SUPERIORITY||Response Rate Difference|2.2|STANDARD_ERROR_OF_MEAN|7.38|=|0.7694|TWO_SIDED|95.0|-12.29|16.64|||Cochran-Mantel-Haenszel|||Week 12||16.64|-12.29|=0.7694
73939111|NCT04162769|147410717|SUPERIORITY||Response Rate Difference|17.4|STANDARD_ERROR_OF_MEAN|8.47|=|0.045|TWO_SIDED|95.0|0.79|34.0|||Cochran-Mantel-Haenszel|||Week 12||34.00|0.79|=0.0450
73939112|NCT04162769|147410718|SUPERIORITY||Least square mean difference|-14.03|STANDARD_ERROR_OF_MEAN|7.295|=|0.0558|TWO_SIDED|95.0|-28.406|0.352|||Mixed Models Analysis|||Week 12||0.352|-28.406|=0.0558
73939113|NCT04162769|147410718|SUPERIORITY||Least square mean difference|-10.67|STANDARD_ERROR_OF_MEAN|7.134|=|0.1363|TWO_SIDED|95.0|-24.737|3.397|||Mixed Models Analysis|||Week 12||3.397|-24.737|=0.1363
73939114|NCT04162769|147410719|SUPERIORITY||Response Rate Difference|4.2|STANDARD_ERROR_OF_MEAN|11.33|=|0.7143|TWO_SIDED|95.0|-18.0|26.41|||Cochran-Mantel-Haenszel|||Week 12||26.41|-18.00|=0.7143
73939115|NCT04162769|147410719|SUPERIORITY||Response Rate Difference|5.1|STANDARD_ERROR_OF_MEAN|11.09|=|0.6488|TWO_SIDED|95.0|-16.62|26.87|||Cochran-Mantel-Haenszel|||Week 12||26.87|-16.62|=0.6488
73939116|NCT04162769|147410720|SUPERIORITY||Response Rate Difference|8.8|STANDARD_ERROR_OF_MEAN|10.22|=|0.3981|TWO_SIDED|95.0|-11.27|28.8|||Cochran-Mantel-Haenszel|||Week 12||28.80|-11.27|=0.3981
73939117|NCT04162769|147410720|SUPERIORITY||Response Rate Difference|15.2|STANDARD_ERROR_OF_MEAN|10.17|=|0.141|TWO_SIDED|95.0|-4.72|35.15|||Cochran-Mantel-Haenszel|||Week 12||35.15|-4.72|=0.1410
73939118|NCT04162769|147410721|SUPERIORITY||Response Rate Difference|8.4|STANDARD_ERROR_OF_MEAN|7.65|=|0.269|TWO_SIDED|95.0|-6.61|23.38|||Cochran-Mantel-Haenszel|||Week 12||23.38|-6.61|=0.2690
74030929|NCT00570739|147615625|SUPERIORITY_OR_OTHER|||||||0.5848||95.0|||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 4 Weeks||||0.5848
73939119|NCT04162769|147410721|SUPERIORITY||Response Rate Difference|4.3|STANDARD_ERROR_OF_MEAN|7.09|=|0.5428|TWO_SIDED|95.0|-9.56|18.25|||Cochran-Mantel-Haenszel|||Week 12||18.25|-9.56|=0.5428
73939120|NCT04162769|147410722|SUPERIORITY||Least square mean difference|-2.81|STANDARD_ERROR_OF_MEAN|7.721|=|0.7163|TWO_SIDED|95.0|-18.089|12.466|||Mixed Models Analysis|||Week 12||12.466|-18.089|=0.7163
73939121|NCT04162769|147410722|SUPERIORITY||Least square mean difference|-13.24|STANDARD_ERROR_OF_MEAN|7.602|=|0.084|TWO_SIDED|95.0|-28.284|1.805|||Mixed Models Analysis|||Week 12||1.805|-28.284|=0.0840
73939122|NCT04402866|147410756|OTHER||Common Odds Ratio|1.142||||0.6137|TWO_SIDED|95.0|0.706|1.846|||Van Elteren test||Common Odds Ratio (TD-0903 vs. placebo) and corresponding 95% Wald confidence interval (CI) were obtained from the proportional odds regression model of RFD adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.||1.846|0.706|0.6137
73939123|NCT04402866|147410757|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|LS mean difference|-0.51||||0.962|TWO_SIDED|95.0|-21.95|20.92|||Mixed model repeated measures model|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group||20.92|-21.95|0.962
73939124|NCT04402866|147410758|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.153||||0.5918|TWO_SIDED|95.0|0.692|1.922|||Van Elteren test||Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 7||1.922|0.692|0.5918
73939125|NCT04402866|147410758|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.105||||0.6978|TWO_SIDED|95.0|0.651|1.878|||Van Elteren test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 14|Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|1.878|0.651|0.6978
73939126|NCT04402866|147410758|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.295||||0.399|TWO_SIDED|95.0|0.702|2.388|||Van Elteren test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 21|Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|2.388|0.702|0.3990
73939127|NCT04402866|147410758|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.18||||0.6445|TWO_SIDED|95.0|0.605|2.299|||Van Elteren test||Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 28||2.299|0.605|0.6445
74030930|NCT00570739|147615625|SUPERIORITY_OR_OTHER|||||||0.8147||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 weeks||||0.8147
74030931|NCT00570739|147615625|SUPERIORITY_OR_OTHER|||||||0.4957||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks||||0.4957
74088969|NCT02985879|147731165|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|2.51|=|0.974|TWO_SIDED|95.0|-4.86|5.02|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||5.02|-4.86|=0.974
73939128|NCT04402866|147410759|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Risk Difference (RD)|5.06||||0.3005|TWO_SIDED|95.0|-4.5|14.63||The p-value was calculated using the Cochran-Mantel-Haenszel chi-square test stratified by baseline age group (≤ 60 years vs. \> 60 years)|Cochran-Mantel-Haenszel chi-square test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group||14.63|-4.50|0.3005
73939129|NCT00386880|147410760|SUPERIORITY_OR_OTHER|||||||0.59||||||Fisher's exact test.|Fisher Exact|||During the acute migraine attack, 90% of allodynic subjects and 75% of subjects without allodynia had phonophobia.||||0.59
73939130|NCT01972841|147410762|SUPERIORITY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.12||0.072|TWO_SIDED|95.0|-0.49|-0.01||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.49|0.072
73939131|NCT01972841|147410762|SUPERIORITY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.033|TWO_SIDED|95.0|-0.44|0.04||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.04|-0.44|0.033
73939132|NCT01972841|147410762|SUPERIORITY||Least squares mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.001|TWO_SIDED|95.0|-0.58|-0.1|||Stratified rank ANCOVA||Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.10|-0.58|0.001
73939133|NCT01972841|147410762|SUPERIORITY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.052|TWO_SIDED|95.0|-0.47|0.01|||Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.47|0.052
73939134|NCT01972841|147410763|SUPERIORITY||Least squares mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED|95.0|-0.57|-0.01||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.57|0.040
73939135|NCT01972841|147410763|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.006|TWO_SIDED|95.0|-0.67|-0.11||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.11|-0.67|0.006
73957928|NCT04173572|147451471|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.49|STANDARD_DEVIATION|8.91|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
73957929|NCT04173572|147451472|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.39|STANDARD_DEVIATION|4.67|||TWO_SIDED|||||||||Posttreatment - Baseline: 11 participants analyzed (had data at both time points)||||
73957930|NCT04173572|147451472|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|3.43|STANDARD_DEVIATION|9.4|||TWO_SIDED|||||||||Posttreatment - Baseline: 11 participants analyzed (had data at both time points)||||
73939136|NCT01972841|147410763|SUPERIORITY||Least squares mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.76|-0.21||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.76|0.001
73939137|NCT01972841|147410763|SUPERIORITY||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.84|-0.28||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.28|-0.84|<0.001
73939138|NCT01972841|147410764|SUPERIORITY||Least squares mean difference|3.85|STANDARD_ERROR_OF_MEAN|3.13||0.219|TWO_SIDED|95.0|-2.29|10.0||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||10.00|-2.29|0.219
73939139|NCT01972841|147410764|SUPERIORITY||Least squares mean difference|8.75|STANDARD_ERROR_OF_MEAN|3.13||0.005|TWO_SIDED|95.0|2.61|14.89||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||14.89|2.61|0.005
73939140|NCT01972841|147410764|SUPERIORITY||Least squares mean difference|21.52|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|15.35|27.68||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||27.68|15.35|<0.001
73939141|NCT01972841|147410764|SUPERIORITY||Least squares mean difference|17.74|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|11.58|23.9||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||23.90|11.58|<0.001
73939142|NCT01972841|147410765|SUPERIORITY||Least squares mean difference|-4.63|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-6.98|-2.27|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-2.27|-6.98|<0.001
73957931|NCT04173572|147451473|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-3.667|STANDARD_DEVIATION|9.067|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
73957932|NCT04173572|147451473|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.071|STANDARD_DEVIATION|12.25|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
74030932|NCT00570739|147615625|SUPERIORITY_OR_OTHER|||||||0.0467||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0467
74088970|NCT02985879|147731170|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|=|0.761|TWO_SIDED|95.0|-0.31|0.23|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.23|-0.31|=0.761
74088971|NCT02985879|147731170|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13|=|0.678|TWO_SIDED|95.0|-0.32|0.21|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.21|-0.32|=0.678
74088972|NCT02985879|147731171|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|2.3|=|0.653|TWO_SIDED|95.0|-3.5|5.57|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||5.57|-3.50|=0.653
73939143|NCT01972841|147410765|SUPERIORITY||Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-8.17|-3.44|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-3.44|-8.17|<0.001
73939144|NCT01972841|147410765|SUPERIORITY||Least squares mean difference|-7.13|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-9.5|-4.76|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-4.76|-9.50|<0.001
73939145|NCT01972841|147410765|SUPERIORITY||Least squares mean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.46|-3.74|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-3.74|-8.46|<0.001
73939146|NCT01972841|147410766|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.14||0.077|TWO_SIDED|95.0|-0.03|0.52|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.52|-0.03|0.077
73939147|NCT01972841|147410766|SUPERIORITY||Least squares mean difference|0.27|STANDARD_ERROR_OF_MEAN|0.14||0.05|TWO_SIDED|95.0|0.0|0.55|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.55|0.00|0.050
73957933|NCT04173572|147451474|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|9.9|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
73957934|NCT04173572|147451474|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.714|STANDARD_DEVIATION|11.717|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
73957935|NCT04173572|147451475|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|3.071|STANDARD_DEVIATION|10.737|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
73957936|NCT04173572|147451475|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|5.571|STANDARD_DEVIATION|9.288|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
73957937|NCT02476890|147451482|OTHER||Mean Difference (Final Values)|0.01||||0.9666|TWO_SIDED|95.0|-0.6|0.7|||Mixed Models Analysis|||C2 Response/Healthy||0.7|-0.6|0.9666
73939148|NCT01972841|147410766|SUPERIORITY||Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.14||0.008|TWO_SIDED|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.65|0.10|0.008
73939149|NCT01972841|147410766|SUPERIORITY||Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.14||0.007|TWO_SIDED|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.65|0.10|0.007
73939150|NCT01972841|147410767|SUPERIORITY||Rate ratio|0.87|STANDARD_ERROR_OF_MEAN|0.09||0.135|TWO_SIDED|95.0|0.72|1.04|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.04|0.72|0.135
73939151|NCT01972841|147410767|SUPERIORITY||Rate ratio|0.9|STANDARD_ERROR_OF_MEAN|0.09||0.282|TWO_SIDED|95.0|0.75|1.09|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.09|0.75|0.282
73939152|NCT01972841|147410767|SUPERIORITY||Rate ratio|0.71|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.59|0.85|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||0.85|0.59|<0.001
73939153|NCT01972841|147410767|SUPERIORITY||Rate ratio|0.88|STANDARD_ERROR_OF_MEAN|0.1||0.172|TWO_SIDED|95.0|0.73|1.06|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.06|0.73|0.172
73939154|NCT01972841|147410768|SUPERIORITY||least squares mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.83||0.074|TWO_SIDED|95.0|-3.27|-0.01|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.offset variable.||-0.01|-3.27|0.074
73939155|NCT01972841|147410768|SUPERIORITY||Least squares mean difference|-1.33|STANDARD_ERROR_OF_MEAN|0.83||0.025|TWO_SIDED|95.0|-2.96|0.3|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.30|-2.96|0.025
73939156|NCT01972841|147410768|SUPERIORITY||least square mean difference|-2.36|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-4.0|-0.73|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.73|-4.00|<0.001
73939157|NCT01972841|147410768|SUPERIORITY||Least squares mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.84||0.024|TWO_SIDED|95.0|-3.23|0.05|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.05|-3.23|0.024
73939158|NCT01972841|147410772|SUPERIORITY||Least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.29||0.52|TWO_SIDED|95.0|-0.39|0.76|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.76|-0.39|0.520
73957938|NCT02476890|147451482|OTHER||Mean Difference (Final Values)|-0.22||||0.5993|TWO_SIDED|95.0|-1.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy||0.6|-1.1|0.5993
73957939|NCT02476890|147451482|OTHER||Mean Difference (Final Values)|0.32||||0.2823|TWO_SIDED|95.0|-0.3|0.9|||Mixed Models Analysis|||C2 Response/Chronic Cough||0.9|-0.3|0.2823
73939159|NCT01972841|147410772|SUPERIORITY||Least squares mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.29||0.413|TWO_SIDED|95.0|-0.82|0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.34|-0.82|0.413
73939160|NCT01972841|147410772|SUPERIORITY||Least squares mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|-1.5|-0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.34|-1.50|0.002
73939161|NCT01972841|147410772|SUPERIORITY||Least squares mean diffrence|-0.56|STANDARD_ERROR_OF_MEAN|0.3||0.06|TWO_SIDED|95.0|-1.13|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.02|-1.13|0.060
73939162|NCT01972841|147410773|SUPERIORITY||Rate ratio|0.85|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|0.7|1.04|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.04|0.70|0.110
73939163|NCT01972841|147410773|SUPERIORITY||Rate ratio|0.9|STANDARD_ERROR_OF_MEAN|0.1||0.288|TWO_SIDED|95.0|0.73|1.1|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.10|0.73|0.288
73939164|NCT01972841|147410773|SUPERIORITY||Rate ratio|0.65|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.53|0.79|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||0.79|0.53|<0.001
73939165|NCT01972841|147410773|SUPERIORITY||Rate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.1||0.084|TWO_SIDED|95.0|0.68|1.02|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.02|0.68|0.084
73939166|NCT01972841|147410774|SUPERIORITY||Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.76||0.114|TWO_SIDED|95.0|-3.09|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.13|-3.09|0.114
73939167|NCT01972841|147410774|SUPERIORITY||Least squares mean difference|-1.62|STANDARD_ERROR_OF_MEAN|0.76||0.034|TWO_SIDED|95.0|-3.1|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.13|-3.10|0.034
73939168|NCT01972841|147410774|SUPERIORITY||Least squares mean difference|-2.61|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|-4.09|-1.12|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-1.12|-4.09|<0.001
73939169|NCT01972841|147410774|SUPERIORITY||Least squares mean difference|-2.21|STANDARD_ERROR_OF_MEAN|0.76||0.012|TWO_SIDED|95.0|-3.7|-0.71|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.71|-3.70|0.012
73939170|NCT01972841|147410775|SUPERIORITY||Least squares mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.134|TWO_SIDED|95.0|-0.46|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.46|0.134
73957940|NCT02476890|147451482|OTHER||Mean Difference (Final Values)|0.25||||0.4287|TWO_SIDED|95.0|-0.4|0.9|||Mixed Models Analysis|||C5 Response/Chronic Cough||0.9|-0.4|0.4287
73939171|NCT01972841|147410775|SUPERIORITY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.043|TWO_SIDED|95.0|-0.45|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.45|0.043
73939172|NCT01972841|147410775|SUPERIORITY||Least squares mean diffeence|-0.37|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.59|-0.15|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.15|-0.59|<0.001
73939173|NCT01972841|147410775|SUPERIORITY||Standard Error of the Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.11||0.019|TWO_SIDED|5.0|-0.54|-0.1|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50mg ) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.10|-0.54|0.019
73939174|NCT01972841|147410776|SUPERIORITY||Least squares mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.074|TWO_SIDED|95.0|-0.69|0.03|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.03|-0.69|0.074
73939175|NCT01972841|147410776|SUPERIORITY||Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.014|TWO_SIDED|95.0|-0.82|-0.09|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.09|-0.82|0.014
73939176|NCT01972841|147410776|SUPERIORITY||Least squares mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.01|-0.28|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.28|-1.01|<0.001
73939177|NCT01972841|147410776|SUPERIORITY||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.24|0.51|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.51|-1.24|<0.001
73939178|NCT01972841|147410777|SUPERIORITY||Rate ratio|0.88|STANDARD_ERROR_OF_MEAN|0.05||0.006|TWO_SIDED|95.0|0.81|0.96|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.96|0.81|0.006
73939179|NCT01972841|147410777|SUPERIORITY||Rate ratio|0.81|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|0.74|0.88|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.88|0.74|<0.001
73939180|NCT01972841|147410777|SUPERIORITY||Rate ratio|0.91|STANDARD_ERROR_OF_MEAN|0.05||0.049|TWO_SIDED|95.0|0.84|1.0|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.00|0.84|0.049
73939181|NCT01972841|147410777|SUPERIORITY||Rate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|0.79|0.94|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.94|0.79|0.001
73939182|NCT01972841|147410778|SUPERIORITY||Least squares mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.34||0.073|TWO_SIDED|95.0|-1.28|0.06|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.06|-1.28|0.073
73957941|NCT02476890|147451483|OTHER||Mean Difference (Final Values)|0.56||||0.1771|TWO_SIDED|95.0|-0.3|1.4|||Mixed Models Analysis|||C2 Response/Healthy||1.4|-0.3|0.1771
73957942|NCT02476890|147451483|OTHER||Mean Difference (Final Values)|0.3||||0.5473|TWO_SIDED|95.0|-0.7|1.3|||Mixed Models Analysis|||C5 Response/Healthy||1.3|-0.7|0.5473
73866871|NCT02332291|147278936|OTHER|Analyses tested for effects of time in this one-arm, open-label study phase.|Slope, fixed effect|-1.186|STANDARD_ERROR_OF_MEAN|0.181|<|0.0001|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|128 degrees of freedom||Statistical analyses utilized mixed models, with MADRS score being the repeated measures dependent variable. Independent variables included time, age, and sex. The primary variable of interest was time, to indicate a change in depression severity over time with open-label treatment.||||<0.0001
73866872|NCT02332291|147278937|OTHER|Analyses tested for effects of time in this one-arm, open-label study phase.|Slope, fixed effects|-0.2342|STANDARD_ERROR_OF_MEAN|0.0908||0.0123|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|61 degrees of freedom||Statistical analyses utilized mixed models, with QIDS score being the repeated measures dependent variable. Independent variables included time, age, and sex. The primary variable of interest was time, to indicate a change in depression severity over time with open-label treatment.||||0.0123
73866873|NCT02332291|147278938|SUPERIORITY||Slope|-0.636|STANDARD_ERROR_OF_MEAN|1.924||0.742|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Regression, Linear|||Statistical analyses used a linear model. Final AES score at week 8 was the dependent variable. Independent variables included age, sex, baseline AES score, baseline MADRS score, and treatment assignment. Treatment assignment was the independent variable of interest.||||0.742
73939183|NCT01972841|147410778|SUPERIORITY||Least squares mean difference|-1.16|STANDARD_ERROR_OF_MEAN|0.34||0.001|TWO_SIDED|95.0|-1.83|-0.48|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.48|-1.83|0.001
73939184|NCT01972841|147410778|SUPERIORITY||Least squares mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.34||0.14|TWO_SIDED|95.0|-1.18|0.17|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.17|-1.18|0.140
73939185|NCT01972841|147410778|SUPERIORITY||Least squares mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-1.88|-0.54|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.54|-1.88|<0.001
73939186|NCT01972841|147410779|SUPERIORITY||Least squares mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.065|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.19|0.065
73939187|NCT01972841|147410779|SUPERIORITY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.07|-0.26|0.001
73957943|NCT02476890|147451483|OTHER||Mean Difference (Final Values)|0.23||||0.5169|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||C2 Response/Chronic Cough||1.0|-0.5|0.5169
73957944|NCT02476890|147451483|OTHER||Mean Difference (Final Values)|0.28||||0.4243|TWO_SIDED|95.0|-0.4|1.0|||Mixed Models Analysis|||C5 Response/Chronic Cough||1.0|-0.4|0.4243
73866874|NCT02332291|147278939|SUPERIORITY||Slope|-5.4705|STANDARD_ERROR_OF_MEAN|2.352||0.0232|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Regression, Linear|||Statistical analyses used a linear regression model. Final RRS score at week 8 was the dependent variable. Independent variables included age, sex, baseline RRS score, baseline MADRS score, and treatment assignment. Treatment assignment was the independent variable of interest.||||0.0232
73957945|NCT02476890|147451484|OTHER||Mean Difference (Final Values)|0.89||||0.1125|TWO_SIDED|95.0|-0.2|2.0|||Mixed Models Analysis|||C2 Response/Healthy||2.0|-0.2|0.1125
73866875|NCT04118595|147278940|SUPERIORITY|||||||0.13|||||||ANCOVA|||||||0.13
73957946|NCT02476890|147451484|OTHER||Mean Difference (Final Values)|0.88||||0.0029|TWO_SIDED|95.0|0.4|1.4|||Mixed Models Analysis|||C5 Response/Healthy||1.4|0.4|0.0029
73957947|NCT02476890|147451484|OTHER||Mean Difference (Final Values)|1.54||||0.0006|TWO_SIDED|95.0|0.7|2.4|||Mixed Models Analysis|||C2 Response/Chronic Cough||2.4|0.7|0.0006
73957948|NCT02476890|147451484|OTHER||Mean Difference (Final Values)|1.3||||0.0067|TWO_SIDED|95.0|0.4|2.2|||Mixed Models Analysis|||C5 Response/Chronic Cough||2.2|0.4|0.0067
73957949|NCT02476890|147451485|OTHER||Mean Difference (Final Values)|0.38|||<|0.0001|TWO_SIDED|95.0|0.2|0.5|||Mixed Models Analysis|||C2 Response/Healthy||0.5|0.2|< 0.0001
73957950|NCT02476890|147451485|OTHER||Mean Difference (Final Values)|0.23||||0.1798|TWO_SIDED|95.0|-0.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy||0.6|-0.1|0.1798
73957951|NCT02476890|147451485|OTHER||Mean Difference (Final Values)|0.3||||0.0011|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||C2 Response/Chronic Cough||0.5|0.1|0.0011
73957952|NCT02476890|147451485|OTHER||Mean Difference (Final Values)|0.28||||0.0023|TWO_SIDED|95.0|0.1|0.4|||Mixed Models Analysis|||C5 Response/Chronic Cough||0.4|0.1|0.0023
73957953|NCT02476890|147451486|OTHER||Mean Difference (Final Values)|-18.0||||0.0037|TWO_SIDED|95.0|-29.8|-6.2|||Mixed Models Analysis|||Cough Severity VAS Analysis||-6.2|-29.8|0.0037
73957954|NCT02476890|147451487|OTHER||Mean Difference (Final Values)|-18.0||||0.002|TWO_SIDED|95.0|-29.1|-7.0|||Mixed Models Analysis|||Urge to Cough VAS Analysis||-7.0|-29.1|0.0020
73866876|NCT04118595|147278941|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||0.41
73866877|NCT04118595|147278942|SUPERIORITY|||||||0.08|||||||ANCOVA|||||||0.08
73866878|NCT04118595|147278943|SUPERIORITY|||||||0.64|||||||ANCOVA|||||||0.64
73866879|NCT04118595|147278944|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||0.57
73866880|NCT04118595|147278945|SUPERIORITY|||||||0.43|||||||ANCOVA|||||||0.43
73866881|NCT04118595|147278946|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.19
73939188|NCT01972841|147410779|SUPERIORITY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1|TWO_SIDED|95.0|-0.18|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.02|-0.18|0.100
73939189|NCT01972841|147410779|SUPERIORITY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.07|-0.26|0.001
73866882|NCT04118595|147278947|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.15
73866883|NCT04118595|147278948|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
73939190|NCT01972841|147410780|SUPERIORITY||Rate ratio|1.01|STANDARD_ERROR_OF_MEAN|0.12||0.938|TWO_SIDED|95.0|0.8|1.27|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.27|0.80|0.938
73957955|NCT02476890|147451488|OTHER||Mean Difference (Final Values)|-3.6||||0.0075|TWO_SIDED|95.0|-6.2|-1.0|||Mixed Models Analysis|||Cough Frequency Analysis||-1.0|-6.2|0.0075
74030933|NCT00570739|147615625|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 16 Weeks LOCF||||0.0589
74030934|NCT00570739|147615625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.0049|TWO_SIDED|95.0|1.38|6.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||6.10|1.38|0.0049
74030935|NCT00570739|147615625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44||||0.0092|TWO_SIDED|95.0|1.25|4.76|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.76|1.25|0.0092
73866884|NCT04118595|147278949|SUPERIORITY|||||||0.36|||||||ANCOVA|||||||0.36
73866885|NCT03624127|147278957|SUPERIORITY||Odds Ratio (OR)|18.71|||<|0.0001|TWO_SIDED|95.0|9.51|36.81|||Cochran-Mantel-Haenszel|||||36.81|9.51|<0.0001
73866886|NCT03624127|147278958|SUPERIORITY||Odds Ratio (OR)|11.09|||<|0.0001|TWO_SIDED|95.0|6.49|18.95|||Cochran-Mantel-Haenszel|||||18.95|6.49|<0.0001
73866887|NCT03624127|147278959|SUPERIORITY||Odds Ratio (OR)|16.15|||<|0.0001|TWO_SIDED|95.0|6.91|37.72|||Cochran-Mantel-Haenszel|||||37.72|6.91|<0.0001
73866888|NCT03624127|147278959|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0002|TWO_SIDED|95.0|1.51|3.6|||Cochran-Mantel-Haenszel|||||3.60|1.51|0.0002
73866889|NCT03624127|147278960|SUPERIORITY||Odds Ratio (OR)|31.3|||<|0.0001|TWO_SIDED|95.0|4.09|239.36|||Cochran-Mantel-Haenszel|||||239.36|4.09|<0.0001
73866890|NCT03624127|147278961|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.0001|TWO_SIDED|95.0|2.07|9.84|||Cochran-Mantel-Haenszel|||||9.84|2.07|<0.0001
73866891|NCT03624127|147278961|SUPERIORITY||Odds Ratio (OR)|39.54|||<|0.0001|TWO_SIDED|95.0|5.29|295.75|||Cochran-Mantel-Haenszel|||||295.75|5.29|<0.0001
73866892|NCT03624127|147278962|SUPERIORITY||Adjusted Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED|95.0|-12.8|-4.9|||ANCOVA|||||-4.9|-12.8|<0.0001
73866893|NCT03624127|147278963|SUPERIORITY||Odds Ratio (OR)|13.67||||0.0013|TWO_SIDED|95.0|1.77|105.5|||Cochran-Mantel-Haenszel|||||105.50|1.77|0.0013
73866894|NCT03624127|147278963|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1702|TWO_SIDED|95.0|0.76|4.42|||Cochran-Mantel-Haenszel|||||4.42|0.76|0.1702
73866895|NCT03624127|147278964|SUPERIORITY||Odds Ratio (OR)|6.04|||<|0.0001|TWO_SIDED|95.0|3.46|10.53|||Cochran-Mantel-Haenszel|||||10.53|3.46|<0.0001
73866896|NCT03624127|147278965|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1049|TWO_SIDED|95.0|0.73|10.96|||Cochran-Mantel-Haenszel|||||10.96|0.73|0.1049
73866897|NCT03624127|147278966|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.78|3.91|||Cochran-Mantel-Haenszel|||||3.91|1.78|<0.0001
73866898|NCT03624127|147278967|SUPERIORITY||Odds Ratio (OR)|2.53|||<|0.0001|TWO_SIDED|95.0|1.7|3.78|||Cochran-Mantel-Haenszel|||||3.78|1.70|<0.0001
73866899|NCT03624127|147278968|SUPERIORITY||Odds Ratio (OR)|11.92|||<|0.0001|TWO_SIDED|95.0|6.69|21.25|||Cochran-Mantel-Haenszel|||||21.25|6.69|<0.0001
73866900|NCT03624127|147278968|SUPERIORITY||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.21|6.04|||Cochran-Mantel-Haenszel|||||6.04|2.21|<0.0001
73866901|NCT03624127|147278969|SUPERIORITY||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|2.16|4.83|||Cochran-Mantel-Haenszel|||||4.83|2.16|<0.0001
73866902|NCT03624127|147278970|SUPERIORITY||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.53|5.6|||Cochran-Mantel-Haenszel|||||5.60|2.53|<0.0001
73866903|NCT03624127|147278971|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.71|4.05|||Cochran-Mantel-Haenszel|||||4.05|1.71|<0.0001
73866904|NCT03624127|147278972|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.96|4.69|||Cochran-Mantel-Haenszel|||||4.69|1.96|<0.0001
73866905|NCT03624127|147278973|SUPERIORITY||Odds Ratio (OR)|3.11|||<|0.0001|TWO_SIDED|95.0|2.06|4.69|||Cochran-Mantel-Haenszel|||||4.69|2.06|<0.0001
73866906|NCT03624127|147278974|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0002|TWO_SIDED|95.0|1.55|4.19|||Cochran-Mantel-Haenszel|||||4.19|1.55|0.0002
73866907|NCT00559988|147279001|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.064||||0.732|TWO_SIDED|95.0|0.75|1.51|||Regression, Cox|||||1.51|0.75|0.732
74030936|NCT00570739|147615626|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|Startified by country||Baseline to 4 Weeks||||0.0008
73866908|NCT01455194|147279011|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.122|STANDARD_ERROR_OF_MEAN|0.1175||0.2988|TWO_SIDED|95.0|-0.353|0.109|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.109|-0.353|0.2988
73866909|NCT01455194|147279011|SUPERIORITY_OR_OTHER||LS Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.118||0.7741|TWO_SIDED|95.0|-0.198|0.266|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.266|-0.198|0.7741
73866910|NCT01455194|147279011|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.156|STANDARD_ERROR_OF_MEAN|0.1172||0.1835|TWO_SIDED|95.0|-0.387|0.074|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.074|-0.387|0.1835
73866911|NCT01455194|147279013|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate|0.0||||0.8465|TWO_SIDED|95.0|-3.0|4.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.|||4.000|-3.000|0.8465
74030937|NCT00570739|147615626|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||0.0280
74030938|NCT00570739|147615626|SUPERIORITY_OR_OTHER|||||||0.0414||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks||||0.0414
74030939|NCT00570739|147615626|SUPERIORITY_OR_OTHER|||||||0.084||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0840
74030940|NCT00570739|147615626|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||0.0589
74030941|NCT00570739|147615626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0095|TWO_SIDED|95.0|1.21|3.96|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||3.96|1.21|0.0095
74030942|NCT00570739|147615626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.0088|TWO_SIDED|95.0|1.2|3.6|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||3.60|1.20|0.0088
74030943|NCT00570739|147615627|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||<0.0001
74030944|NCT00570739|147615627|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||<0.0001
73866912|NCT01455194|147279013|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate|1.0||||0.4175|TWO_SIDED|95.0|-2.0|5.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.|||5.000|-2.000|0.4175
73866913|NCT01455194|147279014|SUPERIORITY_OR_OTHER|||||||0.4186|||||||Fisher Exact|||Well-controlled Asthma||||0.4186
73866914|NCT01455194|147279014|SUPERIORITY_OR_OTHER|||||||0.146|||||||Fisher Exact|||Well-controlled Asthma||||0.1460
73866915|NCT01455194|147279014|SUPERIORITY_OR_OTHER|||||||0.6017|||||||Fisher Exact|||Well-controlled Asthma||||0.6017
73957956|NCT00835380|147451491|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.0||||||95.0|89.0|99.0||||||||99|89|
73866916|NCT01455194|147279014|SUPERIORITY_OR_OTHER|||||||0.3305|||||||Fisher Exact|||ACQ Improvement||||0.3305
73866917|NCT01455194|147279014|SUPERIORITY_OR_OTHER|||||||0.486|||||||Fisher Exact|||ACQ Improvement||||0.4860
73866918|NCT01455194|147279014|SUPERIORITY_OR_OTHER|||||||0.8922|||||||Fisher Exact|||ACQ Improvement||||0.8922
73866919|NCT01455194|147279015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.042|STANDARD_ERROR_OF_MEAN|0.0806||0.6062|TWO_SIDED|95.0|0.89|1.221|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.221|0.890|0.6062
73957957|NCT03247543|147451493|SUPERIORITY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.05||0.0038|TWO_SIDED|95.0|-10.0|-1.9|||Mixed Models for Repeated Measures|||||-1.9|-10.0|0.0038
74030945|NCT00570739|147615627|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||<0.0001
74030946|NCT00570739|147615627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.59|||<|0.0001|TWO_SIDED|95.0|2.78|11.23|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||11.23|2.78|<0.0001
74030947|NCT00570739|147615627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|2.53|9.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||9.10|2.53|<0.0001
74030948|NCT00570739|147615628|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||0.0004
74030949|NCT00570739|147615628|SUPERIORITY_OR_OTHER|||||||0.0326||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0326
74030950|NCT00570739|147615628|SUPERIORITY_OR_OTHER|||||||0.0157||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||0.0157
74030951|NCT00570739|147615628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.087|TWO_SIDED|95.0|0.88|7.07|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||7.07|0.88|0.0870
74030952|NCT00570739|147615628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86||||0.00439|TWO_SIDED|95.0|1.03|7.94|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.94|1.03|0.00439
74030953|NCT00570739|147615629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7959|TWO_SIDED|95.0|-1.32|1.72||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||1.72|-1.32|0.7959
74030954|NCT00570739|147615629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.8371|TWO_SIDED|95.0|-1.28|1.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.57|-1.28|0.8371
74030955|NCT00570739|147615630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0033||||0.4584|TWO_SIDED|95.0|-0.0122|0.0055||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.0055|-0.0122|0.4584
73866920|NCT01455194|147279015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.0669||0.4674|TWO_SIDED|95.0|0.921|1.197|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.197|0.921|0.4674
73866921|NCT01455194|147279015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.201|STANDARD_ERROR_OF_MEAN|0.1597||0.2523|TWO_SIDED|95.0|0.878|1.642|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.642|0.878|0.2523
73866922|NCT01455194|147279015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.913|STANDARD_ERROR_OF_MEAN|0.1354||0.5026|TWO_SIDED|95.0|0.7|1.191|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.191|0.700|0.5026
73866923|NCT01455194|147279015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898|STANDARD_ERROR_OF_MEAN|0.156||0.4893|TWO_SIDED|95.0|0.661|1.219|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.219|0.661|0.4893
73939191|NCT01972841|147410780|SUPERIORITY||Rate ratio|1.0|STANDARD_ERROR_OF_MEAN|0.12||0.967|TWO_SIDED|95.0|0.79|1.25|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.25|0.79|0.967
73939192|NCT01972841|147410780|SUPERIORITY||Standard Error of the Mean|0.73|STANDARD_ERROR_OF_MEAN|0.12||0.008|TWO_SIDED|95.0|0.58|0.92|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.92|0.58|0.008
73939193|NCT01972841|147410780|SUPERIORITY||Rate ratio|0.8|STANDARD_ERROR_OF_MEAN|0.12||0.069|TWO_SIDED|95.0|0.64|1.02|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.02|0.64|0.069
73973607|NCT02938520|147490333|OTHER||Adjusted difference|-4.6||||0.033|TWO_SIDED|95.0|-8.9|-0.4|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||-0.4|-8.9|0.033
74030956|NCT00570739|147615630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0035||||0.4039|TWO_SIDED|95.0|-0.0118|0.0048||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.0048|-0.0118|0.4039
74030957|NCT00570739|147615631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.59|||<|0.0001|TWO_SIDED|95.0|-21.07|-10.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate.||||-10.11|-21.07|<0.0001
73866924|NCT01455194|147279015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.181|STANDARD_ERROR_OF_MEAN|0.1351||0.2193|TWO_SIDED|95.0|0.906|1.538|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.538|0.906|0.2193
73866925|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.058|STANDARD_ERROR_OF_MEAN|0.0917||0.5397|TWO_SIDED|95.0|0.884|1.266|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.266|0.884|0.5397
73866926|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.005|STANDARD_ERROR_OF_MEAN|0.0738||0.9458|TWO_SIDED|95.0|0.87|1.161|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.161|0.870|0.9458
73866927|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026|STANDARD_ERROR_OF_MEAN|0.0708||0.7213|TWO_SIDED|95.0|0.893|1.178|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.178|0.893|0.7213
73866928|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.0692||0.4807|TWO_SIDED|95.0|0.917|1.202|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.202|0.917|0.4807
73866929|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.326|STANDARD_ERROR_OF_MEAN|0.1791||0.115|TWO_SIDED|95.0|0.934|1.884|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.884|0.934|0.1150
73866930|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.074|STANDARD_ERROR_OF_MEAN|0.1467||0.6281|TWO_SIDED|95.0|0.805|1.431|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.431|0.805|0.6281
73866931|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.059|STANDARD_ERROR_OF_MEAN|0.1415||0.6853|TWO_SIDED|95.0|0.803|1.397|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.397|0.803|0.6853
73866932|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.055|STANDARD_ERROR_OF_MEAN|0.1388||0.6995|TWO_SIDED|95.0|0.804|1.385|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.385|0.804|0.6995
73866933|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.837|STANDARD_ERROR_OF_MEAN|0.1744||0.308|TWO_SIDED|95.0|0.595|1.178|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.178|0.595|0.3080
73866934|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.939|STANDARD_ERROR_OF_MEAN|0.1461||0.6645|TWO_SIDED|95.0|0.705|1.25|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.250|0.705|0.6645
73866935|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992|STANDARD_ERROR_OF_MEAN|0.1408||0.9564|TWO_SIDED|95.0|0.753|1.308|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.308|0.753|0.9564
73866936|NCT01455194|147279016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047|STANDARD_ERROR_OF_MEAN|0.1375||0.7367|TWO_SIDED|95.0|0.8|1.371|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.371|0.800|0.7367
73939194|NCT01972841|147410781|SUPERIORITY||Least squares mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.86||0.958|TWO_SIDED|95.0|-1.73|1.64|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||1.64|-1.73|0.958
73939195|NCT01972841|147410781|SUPERIORITY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.86||0.5|TWO_SIDED|95.0|-2.27|1.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||1.11|-2.27|0.500
73939196|NCT01972841|147410781|SUPERIORITY||Least squares mean difference|-1.91|STANDARD_ERROR_OF_MEAN|0.87||0.028|TWO_SIDED|95.0|-3.62|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-3.62|0.028
73939197|NCT01972841|147410781|SUPERIORITY||Least squares mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.88||0.108|TWO_SIDED|95.0|-3.13|0.31|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.31|-3.13|0.108
73939198|NCT01972841|147410782|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.993|TWO_SIDED|95.0|-0.25|0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.25|-0.25|0.993
74088973|NCT02985879|147731171|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|2.3|=|0.748|TWO_SIDED|95.0|-3.5|5.57|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||5.57|-3.50|=0.748
74091658|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.24|||<|0.001|TWO_SIDED|95.0|1.02|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 19A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|1.02|<0.001
73957958|NCT03247543|147451493|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.11||0.0063|TWO_SIDED|95.0|-9.9|-1.7|||Mixed Models for Repeated Measures|||||-1.7|-9.9|0.0063
73957959|NCT03247543|147451494|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0028|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.8|0.0028
73866937|NCT01455194|147279017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.367|STANDARD_ERROR_OF_MEAN|0.2583||0.2264|TWO_SIDED|95.0|0.824|2.267|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||2.267|0.824|0.2264
73866938|NCT01455194|147279017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.102|STANDARD_ERROR_OF_MEAN|0.5001||0.1373|TWO_SIDED|95.0|0.789|5.602|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||5.602|0.789|0.1373
73866939|NCT01455194|147279017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882|STANDARD_ERROR_OF_MEAN|0.4365||0.7732|TWO_SIDED|95.0|0.375|2.074|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||2.074|0.375|0.7732
73866940|NCT01455194|147279018|SUPERIORITY_OR_OTHER|||||||0.288|||||||Fisher Exact|||||||0.2880
73866941|NCT01455194|147279018|SUPERIORITY_OR_OTHER|||||||0.2864|||||||Fisher Exact|||||||0.2864
73866942|NCT02249182|147279024|EQUIVALENCE|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|105.2|||||TWO_SIDED|90.0|90.61|122.13||||||AUCtau of GS-331007 for the 12 to \< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||122.13|90.61|
73866943|NCT02249182|147279024|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|65.76|||||TWO_SIDED|90.0|56.62|76.37||||||AUCtau of GS-331007 for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||76.37|56.62|
74030958|NCT00570739|147615632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.46||||0.2289|TWO_SIDED|95.0|-27.53|6.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||6.62|-27.53|0.2289
74030959|NCT00570739|147615632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54||||0.1997|TWO_SIDED|95.0|-29.22|6.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||6.14|-29.22|0.1997
74030960|NCT00570739|147615633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.81||||0.0144|TWO_SIDED|95.0|2.57|23.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides||23.05|2.57|0.0144
74030961|NCT00570739|147615633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.12||||0.0037|TWO_SIDED|95.0|4.63|23.61||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides||23.61|4.63|0.0037
73973608|NCT02938520|147490334|OTHER||Adjusted difference|1.021||||0.122|TWO_SIDED|95.0|-0.275|2.318|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.318|-0.275|0.122
74030962|NCT00570739|147615633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.79||||0.006|TWO_SIDED|95.0|6.59|39.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides||39.00|6.59|0.0060
74030963|NCT00570739|147615633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.72||||0.0013|TWO_SIDED|95.0|9.71|39.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides||39.73|9.71|0.0013
73973609|NCT02938520|147490334|OTHER||Adjusted difference|1.103||||0.109|TWO_SIDED|95.0|-0.248|2.453|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.453|-0.248|0.109
73973610|NCT02938520|147490334|OTHER||Adjusted difference|0.182||||0.645|TWO_SIDED|95.0|-0.594|0.958|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||0.958|-0.594|0.645
73973611|NCT02938520|147490334|OTHER||Adjusted difference|-0.169||||0.689|TWO_SIDED|95.0|-0.994|0.657|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||0.657|-0.994|0.689
73973612|NCT02938520|147490335|OTHER||Adjusted difference|2.2|||<|0.001|TWO_SIDED|95.0|1.0|3.4|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.4|1.0|<0.001
73973613|NCT02938520|147490335|OTHER||Adjusted difference|0.7||||0.217|TWO_SIDED|95.0|-0.4|1.9|||ANCOVA||Treatment comparison at Week 44 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||1.9|-0.4|0.217
73973614|NCT02938520|147490336|OTHER||Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.8|5.5|||ANOVA||Treatment comparison of HIVTSQc-total treatment satisfaction score at Week 48 is presented, adjusted for Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.5|2.8|<0.001
74030964|NCT00570739|147615633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.35||||0.0005|TWO_SIDED|95.0|3.71|13.0|||ANCOVA|||Calculated High Density Lipoprotein-Cholesterol||13.00|3.71|0.0005
74030965|NCT00570739|147615633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.69||||0.0001|TWO_SIDED|95.0|4.27|13.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated High Density Lipoprotein-Cholesterol||13.11|4.27|0.0001
74030966|NCT00570739|147615634|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.8804|TWO_SIDED|95.0|0.63|2.34||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||2.34|0.63|0.8804
74030967|NCT00570739|147615634|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.5525|TWO_SIDED|95.0|0.73|2.6||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||2.60|0.73|0.5525
73973615|NCT02938520|147490338|OTHER||Adjusted difference|2.2||||0.232|TWO_SIDED|95.0|-1.4|5.7|||ANCOVA||Treatment comparison at Week 8 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.7|-1.4|0.232
73973616|NCT02938520|147490338|OTHER||Adjusted difference|2.7||||0.154|TWO_SIDED|95.0|-1.0|6.4|||ANCOVA||Treatment comparison Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||6.4|-1.0|0.154
74030968|NCT00570739|147615634|SUPERIORITY_OR_OTHER|||||||0.5648||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.5648
74030969|NCT00570739|147615634|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.3170
73939199|NCT01972841|147410782|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.65|TWO_SIDED|95.0|-0.3|0.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.19|-0.30|0.650
73939200|NCT01972841|147410782|SUPERIORITY||Least squares mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.13||0.035|TWO_SIDED|95.0|-0.52|-0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.52|0.035
73939201|NCT01972841|147410782|SUPERIORITY||Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.169|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate||0.08|-0.43|0.169
73939202|NCT01972841|147410783|SUPERIORITY||Odds Ratio (OR)|1.37||||0.003|TWO_SIDED|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.11|0.003
73939203|NCT01972841|147410783|SUPERIORITY||Odds Ratio (OR)|1.36||||0.004|TWO_SIDED|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.11|0.004
73973617|NCT02938520|147490338|OTHER||Adjusted difference|2.2||||0.236|TWO_SIDED|95.0|-1.4|5.8|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.8|-1.4|0.236
73973618|NCT05652010|147490340|OTHER|Comparative study|Odds Ratio (OR)|0.576||||0.164|TWO_SIDED|95.0|0.2634|1.2659||P=0.164 for testing the hypothesis that OR=1|Mixed Models Analysis|Generalized linear mixed model. As it was an exploratory study no adjustment for multiple comparison was performed.|P=0.164 for testing the hypothesis that OR=1|||1.2659|0.2634|0.164
73973619|NCT05652010|147490341|OTHER||Binominal|0.9|||<|0.0001|TWO_SIDED|95.0|0.75|0.97|||Exact test in the binomial distribution|Exact test in the binomial distribution tested if the proportion of very satisfied/satisfied was sign. different from 50% when using a 5% test level|The binomial proportion is based on subjects that have answered the questions. Exact test in the binomial distribution.|||0.97|0.75|<0.0001
73973620|NCT05652010|147490342|OTHER|The binomial proportion is based on subjects that have answered the questions. Exact test in the binomial distribution.|Binominal|0.82|||<|0.0001|TWO_SIDED|95.0|0.66|0.92|||Exact test in the binominal distribution|Exact test in the binomial distribution tested if the proportion of YES was significantly different from 50% when using a 5% test level||||0.92|0.66|<0.0001
73973621|NCT05652010|147490343|OTHER||Odds Ratio (OR)|0.259||||0.027|TWO_SIDED|95.0|0.078|0.855||P=0.027 for testing the hypothesis that OR=1|Mixed Models Analysis|Generalized linear mixed model|P=0.027 for testing the hypothesis that OR=1|||0.855|0.078|0.027
73973622|NCT04163991|147490356|SUPERIORITY||Least Squares (LS) Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.38||0.0296|TWO_SIDED|90.0|-1.47|-0.21||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.21|-1.47|0.0296
73973623|NCT04163991|147490356|SUPERIORITY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.38||0.0355|TWO_SIDED|90.0|-1.44|-0.18||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.18|-1.44|0.0355
73973624|NCT04163991|147490356|SUPERIORITY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.38||0.0364|TWO_SIDED|90.0|-1.44|-0.18||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.18|-1.44|0.0364
73973625|NCT04163991|147490356|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.38||0.0478|TWO_SIDED|90.0|-1.41|-0.13||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.13|-1.41|0.0478
73939204|NCT01972841|147410783|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.29|1.95|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.95|1.29|<0.001
73973626|NCT04163991|147490367|SUPERIORITY||Ratio of geometric mean versus placebo|0.64||||0.0584|TWO_SIDED|90.0|0.43|0.94||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.94|0.43|0.0584
73973627|NCT04163991|147490367|OTHER||Ratio of geometric mean versus placebo|0.76||||0.2274|TWO_SIDED|90.0|0.51|1.11||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||1.11|0.51|0.2274
73973628|NCT04163991|147490367|SUPERIORITY||Ratio of geometric mean versus placebo|0.77||||0.2794|TWO_SIDED|90.0|0.52|1.14||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||1.14|0.52|0.2794
74088974|NCT02985879|147731172|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34|=|0.828|TWO_SIDED|95.0|-0.6|0.74|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.74|-0.60|=0.828
73939205|NCT01972841|147410783|SUPERIORITY||Odds Ratio (OR)|1.36||||0.004|TWO_SIDED|95.0|1.1|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.10|0.004
73939206|NCT01972841|147410784|SUPERIORITY||Odds Ratio (OR)|1.23||||0.039|TWO_SIDED|95.0|1.01|1.5|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.50|1.01|0.039
74088975|NCT02985879|147731172|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.34|=|0.543|TWO_SIDED|95.0|-0.46|0.87|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.87|-0.46|=0.543
73957960|NCT03247543|147451494|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0099|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.1|-0.8|0.0099
73957961|NCT03247543|147451495|SUPERIORITY||Least Square Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.39||0.0064|TWO_SIDED|95.0|-6.5|-1.1|||ANCOVA|||||-1.1|-6.5|0.0064
73957962|NCT03247543|147451495|SUPERIORITY||Least Square Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.46||0.0917|TWO_SIDED|95.0|-5.3|0.4|||ANCOVA|||||0.4|-5.3|0.0917
73957963|NCT03247543|147451496|SUPERIORITY||Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.059||0.0651|TWO_SIDED|95.0|-0.22|0.01|||ANCOVA|||||0.01|-0.22|0.0651
73957964|NCT03247543|147451496|SUPERIORITY||Least Square Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.061||0.168|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||||0.04|-0.20|0.1680
73957965|NCT03247543|147451497|SUPERIORITY||Risk Difference (RD)|10.1||||0.1316|TWO_SIDED|95.0|-2.9|23.1|||Regression, Logistic|||||23.1|-2.9|0.1316
73957966|NCT03247543|147451497|SUPERIORITY||Risk Difference (RD)|15.4||||0.0276|TWO_SIDED|95.0|2.0|28.9|||Regression, Logistic|||||28.9|2.0|0.0276
73957967|NCT03247543|147451498|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.7||0.2128|TWO_SIDED|95.0|-8.7|1.9|||ANCOVA|||||1.9|-8.7|0.2128
73957968|NCT03247543|147451498|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.83||0.0409|TWO_SIDED|95.0|-11.3|-0.2|||ANCOVA|||||-0.2|-11.3|0.0409
73957969|NCT03247543|147451499|SUPERIORITY||Least Square Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.07||0.002|TWO_SIDED|95.0|-5.4|-1.2|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.2|-5.4|0.0020
73957970|NCT03247543|147451499|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|1.09||0.0039|TWO_SIDED|95.0|-5.3|-1.0|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.0|-5.3|0.0039
73957971|NCT03247543|147451499|SUPERIORITY||Least Square Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.05||0.0087|TWO_SIDED|95.0|-4.8|-0.7|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.7|-4.8|0.0087
73957972|NCT03247543|147451499|SUPERIORITY||Least Square Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.09||0.0248|TWO_SIDED|95.0|-4.6|-0.3|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.3|-4.6|0.0248
73957973|NCT03247543|147451500|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.43||0.7003|TWO_SIDED|95.0|-3.3|2.2|||ANCOVA|||||2.2|-3.3|0.7003
73957974|NCT03247543|147451500|SUPERIORITY||Least Square Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.45||0.1602|TWO_SIDED|95.0|-4.9|0.8|||ANCOVA|||||0.8|-4.9|0.1602
73957975|NCT03247543|147451501|SUPERIORITY|||||||0.0236|||||||Chi-squared|||This analysis pertains to Week 1 of treatment.||||0.0236
73957976|NCT03247543|147451501|SUPERIORITY|||||||0.0505|||||||Chi-squared|||This analysis pertains to Week 2 of treatment.||||0.0505
73957977|NCT03247543|147451501|SUPERIORITY|||||||0.1225|||||||Chi-squared|||This analysis pertains to Week 3 of treatment.||||0.1225
73957978|NCT03247543|147451501|SUPERIORITY|||||||0.0254|||||||Chi-squared|||This analysis pertains to Week 4 of treatment.||||0.0254
73957979|NCT03247543|147451501|SUPERIORITY|||||||0.0261|||||||Chi-squared|||This analysis pertains to Week 5 of treatment.||||0.0261
73957980|NCT03247543|147451501|SUPERIORITY|||||||0.0037|||||||Chi-squared|||This analysis pertains to Week 6 of treatment.||||0.0037
73957981|NCT03247543|147451501|SUPERIORITY|||||||0.0385|||||||Chi-squared|||This analysis pertains to Week 7 of treatment.||||0.0385
73957982|NCT03247543|147451501|SUPERIORITY|||||||0.0956|||||||Chi-squared|||This analysis pertains to Week 8 of treatment.||||0.0956
73957983|NCT03247543|147451501|SUPERIORITY|||||||0.0962|||||||Chi-squared|||This analysis pertains to Week 1 of treatment.||||0.0962
73957984|NCT03247543|147451501|SUPERIORITY|||||||0.0744|||||||Chi-squared|||This analysis pertains to Week 2 of treatment.||||0.0744
73957985|NCT03247543|147451501|SUPERIORITY|||||||0.0218|||||||Chi-squared|||This analysis pertains to Week 3 of treatment.||||0.0218
73957986|NCT03247543|147451501|SUPERIORITY|||||||0.115|||||||Chi-squared|||This analysis pertains to Week 4 of treatment.||||0.1150
73939207|NCT01972841|147410784|SUPERIORITY||Odds Ratio (OR)|1.3||||0.009|TWO_SIDED|95.0|1.07|1.59|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.59|1.07|0.009
73939208|NCT01972841|147410784|SUPERIORITY||Odds Ratio (OR)|1.45|||<|0.001|TWO_SIDED|95.0|1.19|1.77|||overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.77|1.19|<0.001
73939209|NCT01972841|147410784|SUPERIORITY||Odds Ratio (OR)|1.5|||<|0.001|TWO_SIDED|95.0|1.23|1.84|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate||1.84|1.23|<0.001
73939210|NCT01972841|147410785|SUPERIORITY||Odds Ratio (OR)|1.32||||0.011|TWO_SIDED|95.0|1.07|1.64|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.64|1.07|0.011
73939211|NCT01972841|147410785|SUPERIORITY||Odds Ratio (OR)|1.41||||0.002|TWO_SIDED|95.0|1.14|1.75|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.75|1.14|0.002
73939212|NCT01972841|147410785|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.32|2.06|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.06|1.32|<0.001
73939213|NCT01972841|147410785|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.33|2.07|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.07|1.33|<0.001
73939214|NCT01972841|147410786|SUPERIORITY||Least squares mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.11|-0.41|<0.001
73939215|NCT01972841|147410786|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.54|-0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.25|-0.54|<0.001
73939216|NCT01972841|147410786|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.50|<0.001
73939217|NCT01972841|147410786|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.50|<0.001
73939218|NCT01972841|147410788|SUPERIORITY||Least squares mean difference|3.81|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|1.69|5.94|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.94|1.69|<0.001
73939219|NCT01972841|147410788|SUPERIORITY||Least squares mean difference|4.16|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|2.03|6.29|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.29|2.03|<0.001
73939220|NCT01972841|147410788|SUPERIORITY||Least squares mean difference|5.02|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|2.88|7.15|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.15|2.88|<0.001
73939221|NCT01972841|147410788|SUPERIORITY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.09||0.002|TWO_SIDED|95.0|1.17|5.43|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.43|1.17|0.002
74030970|NCT00570739|147615635|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.9008|TWO_SIDED|95.0|0.66|4.06||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||4.06|0.66|0.9008
73939222|NCT01972841|147410789|SUPERIORITY||Least squares mean difference|4.12|STANDARD_ERROR_OF_MEAN|1.29||0.001|TWO_SIDED|95.0|1.6|6.65|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.65|1.60|0.001
73939223|NCT01972841|147410789|SUPERIORITY||Lest squares mean difference|4.87|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|2.34|7.4|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.40|2.34|<0.001
73939224|NCT01972841|147410789|SUPERIORITY||Least squares mean difference|6.09|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|3.55|8.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||8.63|3.55|<0.001
73939225|NCT01972841|147410789|SUPERIORITY||Least squares mean difference|3.8|STANDARD_ERROR_OF_MEAN|1.29||0.003|TWO_SIDED|95.0|1.27|6.33|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.33|1.27|0.003
73939226|NCT01972841|147410790|SUPERIORITY||Least squares mean difference|4.24|STANDARD_ERROR_OF_MEAN|1.22||0.001|TWO_SIDED|95.0|1.84|6.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.63|1.84|0.001
73939227|NCT01972841|147410790|SUPERIORITY||Least squares mean difference|4.82|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|2.42|7.22|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.22|2.42|<0.001
73939228|NCT01972841|147410790|SUPERIORITY||Least squares mean difference|5.34|STANDARD_ERROR_OF_MEAN|1.23|<|0.001|TWO_SIDED|95.0|2.93|7.75|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.75|2.93|<0.001
73939229|NCT01972841|147410790|SUPERIORITY||Least squares mean difference|4.41|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|2.01|6.81|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.81|2.01|<0.001
73939230|NCT01972841|147410791|SUPERIORITY||Least squares mean difference|4.42|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|TWO_SIDED|95.0|1.98|6.85|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.85|1.98|<0.001
73939231|NCT01972841|147410791|SUPERIORITY||Least squares mean difference|4.42|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|TWO_SIDED|95.0|1.98|6.86|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.86|1.98|<0.001
74030971|NCT00570739|147615635|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.9035|TWO_SIDED|95.0|0.6|3.37||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||3.37|0.60|0.9035
73939232|NCT01972841|147410791|SUPERIORITY||Least squares mean difference|4.87|STANDARD_ERROR_OF_MEAN|1.25|<|0.001|TWO_SIDED|95.0|2.42|7.32|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.32|2.42|<0.001
73939233|NCT01972841|147410791|SUPERIORITY||Least squares mean difference|3.28|STANDARD_ERROR_OF_MEAN|1.24||0.008|TWO_SIDED|95.0|0.84|5.72|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.72|0.84|0.008
74030972|NCT00570739|147615635|SUPERIORITY_OR_OTHER|||||||0.2874||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2874
73939234|NCT01972841|147410792|SUPERIORITY||Least squares mean difference|2.27|STANDARD_ERROR_OF_MEAN|0.99||0.022|TWO_SIDED|95.0|0.33|4.21|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.21|0.33|0.022
73939235|NCT01972841|147410792|SUPERIORITY||Least squares mean difference|2.25|STANDARD_ERROR_OF_MEAN|0.99||0.023|TWO_SIDED|95.0|0.31|4.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.19|0.31|0.023
73939236|NCT01972841|147410792|SUPERIORITY||Least squares mean difference|2.8|STANDARD_ERROR_OF_MEAN|0.99||0.005|TWO_SIDED|95.0|0.85|4.74|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.74|0.85|0.005
73939237|NCT01972841|147410792|SUPERIORITY||Least squares mean difference|0.95|STANDARD_ERROR_OF_MEAN|0.99||0.337|TWO_SIDED|95.0|-0.99|2.89|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||2.89|-0.99|0.337
73939238|NCT01972841|147410805|SUPERIORITY||Odds Ratio (OR)|1.31||||0.035|TWO_SIDED|95.0|1.02|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.69|1.02|0.035
73939239|NCT01972841|147410805|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.81|1.09|0.009
73939240|NCT01972841|147410805|SUPERIORITY||Odds Ratio (OR)|1.5||||0.002|TWO_SIDED|95.0|1.16|1.93|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.93|1.16|0.002
73939241|NCT01972841|147410805|SUPERIORITY||Odds Ratio (OR)|1.34||||0.023|TWO_SIDED|95.0|1.04|1.73|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.73|1.04|0.023
73939242|NCT01972841|147410806|SUPERIORITY||Odds Ratio (OR)|1.22||||0.224|TWO_SIDED|95.0|0.88|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.69|0.88|0.224
73973629|NCT04163991|147490367|SUPERIORITY||Ratio of geometric mean versus placebo|0.57||||0.0199|TWO_SIDED|90.0|0.39|0.85||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.85|0.39|0.0199
73939243|NCT01972841|147410806|SUPERIORITY||Odds Ratio (OR)|1.42||||0.037|TWO_SIDED|95.0|1.02|1.96|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.96|1.02|0.037
73957987|NCT03247543|147451501|SUPERIORITY|||||||0.1086|||||||Chi-squared|||This analysis pertains to Week 5 of treatment.||||0.1086
73957988|NCT03247543|147451501|SUPERIORITY|||||||0.0082|||||||Chi-squared|||This analysis pertains to Week 6 of treatment.||||0.0082
73957989|NCT03247543|147451501|SUPERIORITY|||||||0.2326|||||||Chi-squared|||This analysis pertains to Week 7 of treatment.||||0.2326
73957990|NCT03247543|147451501|SUPERIORITY|||||||0.0883|||||||Chi-squared|||This analysis pertains to Week 8 of treatment.||||0.0883
73957991|NCT01097343|147451502|SUPERIORITY_OR_OTHER||||||=|0.02|TWO_SIDED|95.0|||||Chi-squared|||A sample of size of 50 patients for the cross-over study was chosen because it provided 80% power to detect a decrease in the rate of high on-clopidogrel platelet reactivity (HPR, defined as \>230 PRU) from 75% to 46% with high dose clopidogrel, with a two-sided alpha of 0.05||||=0.02
73957992|NCT02059980|147451503|SUPERIORITY||||||=|0.56|||||||Mixed Models Analysis|||It was calculated that 30 participants rnadomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).||||= 0.56
73957993|NCT02059980|147451504|SUPERIORITY||||||=|0.98|||||||Mixed Models Analysis|||It was calculated that 30 participants randomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).||||=.98
73939244|NCT01972841|147410806|SUPERIORITY||Odds Ratio (OR)|1.98|||<|0.001|TWO_SIDED|95.0|1.47|2.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.67|1.47|<0.001
73939245|NCT01972841|147410806|SUPERIORITY||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.21|2.26|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.26|1.21|0.002
73939246|NCT01972841|147410807|SUPERIORITY||Odds Ratio (OR)|1.29||||0.077|TWO_SIDED|95.0|0.97|1.72|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.72|0.97|0.077
73939247|NCT01972841|147410807|SUPERIORITY||Odds Ratio (OR)|1.15||||0.321|TWO_SIDED|95.0|0.87|1.53|||Logistic regression|||Odds ratio from a logistic regression model treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.53|0.87|0.321
73939248|NCT01972841|147410807|SUPERIORITY||Odds Ratio (OR)|1.92|||<|0.001|TWO_SIDED|95.0|1.46|2.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.53|1.46|<0.001
73939249|NCT01972841|147410807|SUPERIORITY||Odds Ratio (OR)|1.16||||0.294|TWO_SIDED|95.0|0.88|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.53|0.88|0.294
73939250|NCT01972841|147410808|SUPERIORITY||Odds Ratio (OR)|1.17||||0.251|TWO_SIDED|95.0|0.89|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.53|0.89|0.251
73973630|NCT04163991|147490368|SUPERIORITY||Ratio of geometric mean versus placebo|0.64||||0.0007|TWO_SIDED|90.0|0.52|0.79||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.79|0.52|0.0007
73973631|NCT04163991|147490368|SUPERIORITY||Ratio of geometric mean versus placebo|0.62||||0.0003|TWO_SIDED|90.0|0.5|0.76||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.76|0.50|0.0003
73939251|NCT01972841|147410808|SUPERIORITY||Odds Ratio (OR)|1.25||||0.107|TWO_SIDED|95.0|0.95|1.64|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.64|0.95|0.107
73939252|NCT01972841|147410808|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||2.07|1.23|<0.001
73939253|NCT01972841|147410808|SUPERIORITY||Odds Ratio (OR)|1.41||||0.012|TWO_SIDED|95.0|1.08|1.85|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.85|1.08|0.012
73939254|NCT01972841|147410809|SUPERIORITY||Odds Ratio (OR)|1.3||||0.044|TWO_SIDED|95.0|1.01|1.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.67|1.01|0.044
73939255|NCT01972841|147410809|SUPERIORITY||Odds Ratio (OR)|1.43||||0.006|TWO_SIDED|95.0|1.11|1.84|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.84|1.11|0.006
73939256|NCT01972841|147410809|SUPERIORITY||Odds Ratio (OR)|1.47||||0.004|TWO_SIDED|95.0|1.13|1.9|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.90|1.13|0.004
73939257|NCT01972841|147410809|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.23|2.08|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.08|1.23|<0.001
73973632|NCT04163991|147490368|SUPERIORITY||Ratio of geometric mean versus placebo|0.6||||0.0001|TWO_SIDED|90.0|0.48|0.74||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.74|0.48|0.0001
74030973|NCT00570739|147615635|SUPERIORITY_OR_OTHER|||||||0.4344||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.4344
73939258|NCT01972841|147410810|SUPERIORITY||Odds Ratio (OR)|1.47||||0.004|TWO_SIDED|95.0|1.13|1.92|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.92|1.13|0.004
73939259|NCT01972841|147410810|SUPERIORITY||Odds Ratio (OR)|1.62|||<|0.001|TWO_SIDED|95.0|1.24|2.11|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.11|1.24|<0.001
73973633|NCT04163991|147490368|SUPERIORITY||Ratio of geometric mean versus placebo|0.47|||<|0.0001|TWO_SIDED|90.0|0.38|0.59||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.59|0.38|< 0.0001
73973634|NCT04163991|147490369|SUPERIORITY||Odds Ratio (OR)|1.4||||0.775|TWO_SIDED|90.0|0.2|8.0||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||8.0|0.2|0.7750
73973635|NCT04163991|147490369|SUPERIORITY||Odds Ratio (OR)|0.6||||0.6974|TWO_SIDED|90.0|0.1|5.5||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||(Lower limit of 90% CI is \< 0.1.) Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.5|0.1|0.6974
73939260|NCT01972841|147410810|SUPERIORITY||Odds Ratio (OR)|1.59||||0.001|TWO_SIDED|95.0|1.22|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.07|1.22|0.001
73939261|NCT01972841|147410810|SUPERIORITY||Odds Ratio (OR)|1.57||||0.001|TWO_SIDED|95.0|1.21|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.04|1.21|0.001
73939262|NCT01972841|147410811|SUPERIORITY||Odds Ratio (OR)|1.32||||0.065|TWO_SIDED|95.0|0.98|1.78|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||1.78|0.98|0.065
73939263|NCT01972841|147410811|SUPERIORITY||Odds Ratio (OR)|1.68||||0.001|TWO_SIDED|95.0|1.24|2.27|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.27|1.24|0.001
73939264|NCT01972841|147410811|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.32|2.36|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.36|1.32|<0.001
73939265|NCT01972841|147410811|SUPERIORITY||Odds Ratio (OR)|1.51||||0.007|TWO_SIDED|95.0|1.12|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.04|1.12|0.007
73939266|NCT01972841|147410812|SUPERIORITY||Odds Ratio (OR)|1.44||||0.007|TWO_SIDED|95.0|1.11|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||1.87|1.11|0.007
73939267|NCT01972841|147410812|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.17|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.17|1.28|<0.001
73939268|NCT01972841|147410812|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.34|2.3|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.30|1.34|<0.001
73973636|NCT04163991|147490369|SUPERIORITY||Odds Ratio (OR)|0.9||||0.9318|TWO_SIDED|90.0|0.1|5.7||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.7|0.1|0.9318
73973637|NCT04163991|147490369|SUPERIORITY||Odds Ratio (OR)|0.9||||0.9108|TWO_SIDED|90.0|0.2|5.1||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.1|0.2|0.9108
73973638|NCT04163991|147490370|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
73939269|NCT01972841|147410812|SUPERIORITY||Odds Ratio (OR)|1.68|||<|0.001|TWO_SIDED|95.0|1.29|2.19|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.19|1.29|<0.001
73939270|NCT01972841|147410813|SUPERIORITY||Odds Ratio (OR)|1.12||||0.381|TWO_SIDED|95.0|0.87|1.45|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||1.45|0.87|0.381
73973639|NCT04163991|147490370|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
73973640|NCT04163991|147490370|SUPERIORITY||Hazard Ratio (HR)|3.01||||0.3407|TWO_SIDED|90.0|0.45|20.09||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||20.09|0.45|0.3407
73866944|NCT02249182|147279024|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|94.08|||||TWO_SIDED|90.0|82.51|107.27||||||AUCtau of GS-331007 for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||107.27|82.51|
73866945|NCT02249182|147279024|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|127.18|||||TWO_SIDED|90.0|94.89|170.45||||||AUCtau of LDV for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||170.45|94.89|
73866946|NCT02249182|147279024|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|82.25|||||TWO_SIDED|90.0|61.34|110.3||||||AUCtau of LDV for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||110.30|61.34|
73866947|NCT02249182|147279024|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|120.46|||||TWO_SIDED|90.0|93.18|155.73||||||AUCtau of LDV for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||155.73|93.18|
73866948|NCT02249182|147279024|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|159.88|||||TWO_SIDED|90.0|137.89|185.37||||||AUCtau of SOF for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||185.37|137.89|
73939271|NCT01972841|147410813|SUPERIORITY||Odds Ratio (OR)|1.31||||0.04|TWO_SIDED|95.0|1.01|1.7|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||1.70|1.01|0.040
73939272|NCT01972841|147410813|SUPERIORITY||Odds Ratio (OR)|1.56||||0.001|TWO_SIDED|95.0|1.21|2.0|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.00|1.21|0.001
73973641|NCT04163991|147490370|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
73973642|NCT04564209|147490457|SUPERIORITY|||||||0.455|||||||ANOVA|||||||.455
73973643|NCT04564209|147490458|SUPERIORITY|||||||0.415|||||||ANOVA|||||||.415
73973644|NCT04564209|147490459|SUPERIORITY|||||||0.443|||||||ANOVA|||||||.443
74030974|NCT00570739|147615636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.62|||<|0.0001|TWO_SIDED|95.0|-24.61|-14.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-14.63|-24.61|<0.0001
73973645|NCT04564209|147490460|SUPERIORITY|||||||0.457|||||||ANOVA|||||||.457
73973646|NCT04564209|147490461|SUPERIORITY|||||||0.099|||||||ANOVA|||||||.099
73973647|NCT04564209|147490462|SUPERIORITY|||||||0.338|||||||ANOVA|||||||.338
73973648|NCT04564209|147490463|SUPERIORITY|||||||0.723|||||||ANOVA|||||||.723
74030975|NCT00570739|147615636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47|||<|0.0001|TWO_SIDED|95.0|-23.24|-11.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-11.69|-23.24|<0.0001
73866949|NCT02249182|147279024|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||TWO_SIDED|90.0|110.79|151.32||||||AUCtau of SOF for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||151.32|110.79|
73866950|NCT02249182|147279024|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|187.76|||||TWO_SIDED|90.0|143.41|245.82||||||AUCtau of SOF for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||245.82|143.41|
73866951|NCT00788710|147279062|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
73866952|NCT00788710|147279062|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
73866953|NCT00788710|147279063|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
73866954|NCT00788710|147279063|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
73866955|NCT00788710|147279064|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
73866956|NCT00788710|147279064|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
73866957|NCT02262754|147279087|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Placebo)|0.16|||||TWO_SIDED|90.0|-0.28|0.6||||||An analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward (LOCF) was used for missing data.||0.60|-0.28|
73973649|NCT04564209|147490465|SUPERIORITY|||||||0.578|||||||t-test, 2 sided|||||||.578
73973650|NCT04564209|147490466|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||||||.998
73973651|NCT04564209|147490467|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||||||.864
73973652|NCT02911805|147490468|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73973653|NCT02624050|147490477|SUPERIORITY||Risk Ratio (RR)|1.0||||0.01|TWO_SIDED|||||Threshold for significance was p\<0.05.|log-binomial regression|||||||0.01
73973654|NCT02624050|147490478|SUPERIORITY||Risk Ratio (RR)|1.0||||0.37|TWO_SIDED|||||Threshold of significance was \<0.05|log binomial regression|||||||0.37
73939273|NCT01972841|147410813|SUPERIORITY||Odds Ratio (OR)|1.57||||0.001|TWO_SIDED|95.0|1.21|2.03|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.03|1.21|0.001
73939274|NCT01972841|147410814|SUPERIORITY||Odds Ratio (OR)|1.24||||0.095|TWO_SIDED|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.59|0.96|0.095
73939275|NCT01972841|147410814|SUPERIORITY||Odds Ratio (OR)|1.26||||0.073|TWO_SIDED|95.0|0.98|1.62|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.62|0.98|0.073
73939276|NCT01972841|147410814|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.29|2.13|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.13|1.29|<0.001
73939277|NCT01972841|147410814|SUPERIORITY||Odds Ratio (OR)|1.27||||0.067|TWO_SIDED|95.0|0.98|1.63|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.63|0.98|0.067
73939278|NCT01972841|147410815|SUPERIORITY||Odds Ratio (OR)|1.18||||0.21|TWO_SIDED|95.0|0.91|1.52|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||1.52|0.91|0.210
73939279|NCT01972841|147410815|SUPERIORITY||Odds Ratio (OR)|1.46||||0.004|TWO_SIDED|95.0|1.13|1.89|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||1.89|1.13|0.004
73939280|NCT01972841|147410815|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.06|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||2.06|1.23|<0.001
73939281|NCT01972841|147410815|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.05|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||2.05|1.23|<0.001
73939282|NCT01972841|147410816|SUPERIORITY||Odds Ratio (OR)|1.13||||0.335|TWO_SIDED|95.0|0.88|1.46|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||1.46|0.88|0.335
73939283|NCT01972841|147410816|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||1.81|1.09|0.009
73939284|NCT01972841|147410816|SUPERIORITY||Odds Ratio (OR)|1.56||||0.001|TWO_SIDED|95.0|1.21|2.02|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.02|1.21|0.001
73939285|NCT01972841|147410816|SUPERIORITY||Odds Ratio (OR)|1.71|||<|0.001|TWO_SIDED|95.0|1.33|2.21|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.21|1.33|<0.001
73939286|NCT01972841|147410817|SUPERIORITY||Odds Ratio (OR)|1.11||||0.416|TWO_SIDED|95.0|0.86|1.43|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.43|0.86|0.416
73939287|NCT01972841|147410817|SUPERIORITY||Odds Ratio (OR)|1.23||||0.105|TWO_SIDED|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.59|0.96|0.105
73939288|NCT01972841|147410817|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.28|2.16|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||2.16|1.28|<0.001
73973655|NCT02624050|147490483|SUPERIORITY|||||||0.277||||||"Because the data were skewed, the natural logarithmic transformation was used prior to analysis for inference.~Threshold for statistical significance was \<0.05"|Ratio of Geometric Means|This p-value is for 15 min after induction of anesthesia||||||0.277
73973656|NCT03904576|147490488|OTHER||Difference of least squares means (T-R)|-7.305|STANDARD_ERROR_OF_MEAN|2.082|||TWO_SIDED|90.0|-10.949|-3.661||||||Mixed effects model including effects for 'treatment', 'period' and 'subject' as well as covariates 'period baseline' and 'subject baseline'.||-3.661|-10.949|
73973657|NCT03904576|147490488|OTHER||Difference in %|-24.396|||||||||||||Difference of least squares means in % (ratio to Placebo) (T-R)/R\*100%|Mixed effects model including effects for 'treatment', 'period' and 'subject' as well as covariates 'period baseline' and 'subject baseline'.||||
73973658|NCT03279978|147490493|OTHER||Slope|0.7124|STANDARD_ERROR_OF_MEAN|0.0694|||TWO_SIDED|95.0|0.5702|0.8546||||||Dose proportionality for AUC0-24 of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data). In this study AUCtau,1 = AUC0-24|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.8546|0.5702|
73973659|NCT03279978|147490493|OTHER||Slope|0.5964|STANDARD_ERROR_OF_MEAN|0.0575|||TWO_SIDED|95.0|0.4777|0.7151||||||Dose proportionality for AUC0-24 of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data). In this study AUCtau,1 = AUC0-24|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7151|0.4777|
73973660|NCT03279978|147490494|OTHER||Slope|0.6445|STANDARD_ERROR_OF_MEAN|0.0649|||TWO_SIDED|95.0|0.5124|0.7766||||||Dose proportionality for Cmax of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7766|0.5124|
73973661|NCT03279978|147490494|OTHER||Slope|0.6223|STANDARD_ERROR_OF_MEAN|0.0715|||TWO_SIDED|95.0|0.4747|0.7699||||||Dose proportionality for Cmax of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7699|0.4747|
73973662|NCT03279978|147490495|OTHER||Slope|0.6401|STANDARD_ERROR_OF_MEAN|0.0909|||TWO_SIDED|95.0|0.4545|0.8258||||||Dose proportionality for AUCτ,ss of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.8258|0.4545|
73973663|NCT03279978|147490495|OTHER||Slope|0.5811|STANDARD_ERROR_OF_MEAN|0.0864|||TWO_SIDED|95.0|0.4013|0.7609||||||Dose proportionality for AUCτ,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7609|0.4013|
73973664|NCT03279978|147490496|OTHER||Slope|0.6005|STANDARD_ERROR_OF_MEAN|0.0722|||TWO_SIDED|95.0|0.4534|0.7477||||||Dose proportionality for Cmax,ss of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7477|0.4534|
73866958|NCT02262754|147279087|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Naproxen)|0.42|||||TWO_SIDED|90.0|-0.02|0.87||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.||0.87|-0.02|
73973665|NCT03279978|147490496|OTHER||Slope|0.5799|STANDARD_ERROR_OF_MEAN|0.0656|||TWO_SIDED|95.0|0.4441|0.7156||||||Dose proportionality for Cmax,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7156|0.4441|
73973666|NCT00626795|147490506|NON_INFERIORITY|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|4.56|||||TWO_SIDED|95.0|-1.59|10.71|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).|||10.71|-1.59|
73973667|NCT00626795|147490506|NON_INFERIORITY|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|-3.35|||||TWO_SIDED|95.0|-10.28|3.57|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).|||3.57|-10.28|
73973668|NCT03990883|147490532|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|0.37|||<|0.0001|TWO_SIDED|95.0|-2.96|3.7|||McNemar|||||3.7|-2.96|<0.0001
74030976|NCT00570739|147615637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.47|||<|0.0001|TWO_SIDED|95.0|-16.26|-8.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-8.69|-16.26|<0.0001
74030977|NCT00570739|147615637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.28|||<|0.0001|TWO_SIDED|95.0|-15.15|-5.41||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-5.41|-15.15|<0.0001
73939289|NCT01972841|147410817|SUPERIORITY||Odds Ratio (OR)|1.45||||0.005|TWO_SIDED|95.0|1.12|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.87|1.12|0.005
73939290|NCT03712891|147410832|OTHER|t-test||||||0.12|||||||t-test, 2 sided|||||||0.12
73939291|NCT02308748|147410870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8||||0.025|TWO_SIDED|95.0|-25.2|-14.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.||-14.3|-25.2|0.025
73939292|NCT02308748|147410870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.7||||0.025|TWO_SIDED|95.0|-25.2|-14.1||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.||-14.1|-25.2|0.025
73939293|NCT02308748|147410870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.2||||0.025|TWO_SIDED|95.0|-28.0|-18.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.||-18.3|-28.0|0.025
73939294|NCT02308748|147410870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.5||||0.025|TWO_SIDED|95.0|-25.5|-15.5||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.||-15.5|-25.5|0.025
73939295|NCT02308748|147410871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.025|TWO_SIDED|95.0|-1.0|6.7||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||||6.7|-1|0.025
73939296|NCT02979262|147410891|SUPERIORITY||||||>|0.1|||||||Repeated Measures GLM|Time 2 at 16 weeks||||||>.10
73939297|NCT02979262|147410892|SUPERIORITY||||||<|0.01|||||||GEE|||||||<.01
73939298|NCT02979262|147410893|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
74030978|NCT00570739|147615637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.06||||0.0002|TWO_SIDED|95.0|-13.69|-4.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-4.42|-13.69|0.0002
74030979|NCT00570739|147615638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.96||||0.0357|TWO_SIDED|95.0|0.27|7.66||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||7.66|0.27|0.0357
73939299|NCT02979262|147410894|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
73939300|NCT02979262|147410895|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
73939301|NCT02979262|147410896|SUPERIORITY||||||<|0.01|||||||GEE|||||||<.01
73939302|NCT01565707|147410897|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|12.1|STANDARD_ERROR_OF_MEAN|6.0||0.046|TWO_SIDED|95.0|0.2|24.0|||ANCOVA|From an ANCOVA (analysis of covariance) model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||"The following hypotheses were tested at the 2-sided significance level 0.05:~* H0: Change from baseline to EoT in mean MVV per micturition is the same for placebo and solifenacin succinate oral suspension~* H1: Change from baseline to EoT in mean MVV per micturition is not the same for placebo and solifenacin succinate oral suspension"||24.0|0.2|0.046
73939303|NCT01565707|147410897|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|15.7|||TWO_SIDED|95.0|-36.7|27.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||27.4|-36.7|
73939304|NCT01565707|147410898|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|31.9|STANDARD_ERROR_OF_MEAN|13.9||0.024|TWO_SIDED|95.0|4.3|59.5|||ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||59.5|4.3|0.024
73939305|NCT01565707|147410898|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-17.3|STANDARD_ERROR_OF_MEAN|29.1|||TWO_SIDED|95.0|-76.5|41.9|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||41.9|-76.5|
73939306|NCT01565707|147410899|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.763|TWO_SIDED|95.0|-0.3|0.4||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.4|-0.3|0.763
73939307|NCT01565707|147410899|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.8|1.0|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.0|-0.8|
73939308|NCT01565707|147410900|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.402|TWO_SIDED|95.0|-0.5|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-0.5|0.402
73939309|NCT01565707|147410900|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.5|0.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.4|-1.5|
73939310|NCT01565707|147410901|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.63|TWO_SIDED|95.0|0.0|0.2||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.2|0.0|0.630
73939311|NCT01565707|147410901|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.2|0.2|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate..|||0.2|-0.2|
73939312|NCT01565707|147410902|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.563|TWO_SIDED|95.0|-1.0|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-1.0|0.563
73939313|NCT01565707|147410902|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.6|1.9|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.9|-1.6|
73939314|NCT01565707|147410903|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.77|TWO_SIDED|95.0|-0.9|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-0.9|0.770
73939315|NCT01565707|147410903|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.4|1.3|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.3|-0.4|
73939316|NCT01565707|147410904|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.303|TWO_SIDED|95.0|-0.8|0.2||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|ANCOVA|||||0.2|-0.8|0.303
73939317|NCT01565707|147410904|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.9|1.1|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.1|-0.9|
73939318|NCT01565707|147410905|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.64|TWO_SIDED|95.0|-0.8|0.5|||ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.5|-0.8|0.640
73939319|NCT01565707|147410905|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-0.9|1.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.4|-0.9|
73939320|NCT01565707|147410906|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.846|TWO_SIDED|95.0|-0.3|0.1||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.1|-0.3|0.846
73939321|NCT01565707|147410906|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.0|0.5|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.5|-1.0|
73939322|NCT01565707|147410907|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.4|0.8|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.8|-1.4|
73973669|NCT03990883|147490533|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|0.0|||<|0.0001|TWO_SIDED|95.0|-3.71|3.71||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.71|-3.71|<0.0001
73939323|NCT01371851|147410938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0529||||0.05|TWO_SIDED||||||Regression, Logistic|||The analysis was applied to urine data obtained at all time points during weeks 1-8.||||0.05
73939324|NCT00833638|147410939|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||P-value for day \<=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 2.5 mg and placebo as determined by the earliest day on which the cumulative percentage of subjects achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.086
73939325|NCT00833638|147410939|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for day \<=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.006
73939326|NCT00833638|147410939|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for day \<=3. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.019
73939327|NCT00833638|147410939|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for day \<=2. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.022
73939328|NCT00833638|147410939|SUPERIORITY_OR_OTHER|||||||0.573||95.0||||P-value for day \<=1. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.573
73939329|NCT00833638|147410940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.03|||<|0.001|TWO_SIDED|95.0|5.72|18.34||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||18.34|5.72|<0.001
73939330|NCT00833638|147410940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|||<|0.001|TWO_SIDED|95.0|6.48|19.12||No adjustment for multiplicity.|ANCOVA|Terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 5 mg."||19.12|6.48|<0.001
73939331|NCT00833638|147410941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4|||<|0.001|TWO_SIDED|95.0|8.51|22.29||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||22.29|8.51|<0.001
73939332|NCT00833638|147410941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.41|||<|0.001|TWO_SIDED|95.0|13.5|27.31||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 5 mg."||27.31|13.50|<0.001
73939333|NCT00833638|147410942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.27|||<|0.001|TWO_SIDED|95.0|6.83|21.71||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||21.71|6.83|<0.001
73939334|NCT00833638|147410942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.54|||<|0.001|TWO_SIDED|95.0|13.07|28.01||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 5 mg."||28.01|13.07|<0.001
73939335|NCT00833638|147410943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.24|||<|0.001|TWO_SIDED|95.0|6.42|22.06||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||22.06|6.42|<0.001
74030980|NCT00570739|147615638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.6878|TWO_SIDED|95.0|-5.01|3.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||3.31|-5.01|0.6878
74030981|NCT00570739|147615638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7972|TWO_SIDED|95.0|-4.37|3.36||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||3.36|-4.37|0.7972
74030982|NCT00570739|147615639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.91|||<|0.0001|TWO_SIDED|95.0|-12.02|-5.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-5.80|-12.02|<0.0001
74030983|NCT00570739|147615639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-12.25|-4.26||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-4.26|-12.25|<0.0001
74030984|NCT00570739|147615639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.23||||0.0002|TWO_SIDED|95.0|-11.03|-3.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-3.44|-11.03|0.0002
74030985|NCT00570739|147615640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.0257|TWO_SIDED|95.0|0.43|6.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||6.57|0.43|0.0257
73939336|NCT00833638|147410943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.81|||<|0.001|TWO_SIDED|95.0|13.94|29.67||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 5 mg."||29.67|13.94|<0.001
73939337|NCT00833638|147410944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.92|||<|0.001|TWO_SIDED|95.0|6.3|21.55||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||21.55|6.30|<0.001
73939338|NCT00833638|147410944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.07|||<|0.001|TWO_SIDED|95.0|11.4|26.75||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 5 mg."||26.75|11.40|<0.001
73939339|NCT00833638|147410945|SUPERIORITY_OR_OTHER|||||||0.301||95.0||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.301
73939340|NCT00833638|147410945|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.046
73939341|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73973670|NCT03990883|147490534|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-2.96||||0.025|TWO_SIDED|95.0|-9.99|4.07||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||4.07|-9.99|0.025
73973671|NCT03990883|147490535|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.45||||0.009|TWO_SIDED|95.0|-8.42|7.52||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||7.52|-8.42|0.009
73973672|NCT03990883|147490536|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.37|||<|0.0001|TWO_SIDED|95.0|-3.85|3.11||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.11|-3.85|<0.0001
73973673|NCT03990883|147490537|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.45|||<|0.0001|TWO_SIDED|95.0|-4.05|3.16||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.16|-4.05|<0.0001
73973674|NCT03364127|147490573|SUPERIORITY||Mean Difference (Net)|-0.12||||0.702|TWO_SIDED|95.0|-0.76|0.51|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||.51|-.76|0.702
73973675|NCT03364127|147490574|SUPERIORITY||Mean Difference (Net)|0.1||||0.77|TWO_SIDED|95.0|-0.58|0.79|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||.79|-.58|0.77
73939342|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939343|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939344|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939345|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939346|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939347|NCT00833638|147410946|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
73939348|NCT00833638|147410946|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for day \<=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.001
73939349|NCT00833638|147410946|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
73973676|NCT03364127|147490575|SUPERIORITY||Mean Difference (Net)|1.16||||0.436|TWO_SIDED|95.0|-1.76|4.09|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||4.09|-1.76|0.436
73939350|NCT00833638|147410946|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
73939351|NCT00833638|147410946|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
73939352|NCT00833638|147410946|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for day \<=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.009
73939353|NCT00833638|147410946|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for day \<=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.038
73939354|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939355|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939356|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939357|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939358|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73973677|NCT03364127|147490576|SUPERIORITY||Hazard Ratio (HR)|2.72||||0.017|TWO_SIDED|95.0|1.13|6.54||Kaplan-Meier curves by treatment arm were examined to determine the rates of return to baseline over the 12-week follow-up period .|Log Rank|||Goal was to assess duration of effect among those who showed a response to the intervention (1.5 or greater decrease in PIN).||6.54|1.13|0.017
73973678|NCT06356285|147490577|EQUIVALENCE|Quasibinominal models were used as the outcomes are bounded count variables. Accepting a two-sided p-value adjusted for 3 comparisons, the study was designed with 80% power to detect a minimal detectable effect size between the trial arms and control for the primary outcome.|Odds Ratio, log|0.05||||0.017|TWO_SIDED|95.0||||A two-sided p-value, as shown in the table, which was adjusted for 3 comparisons|Quasibinominal regression|||||||0.017
73973679|NCT01223352|147490650|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.85|||||TWO_SIDED|95.0|0.61|1.2||No statistical test of hypothesis was set for this study. The analysis of PK data was carried out descriptively|||b.i.d. bosentan regimen was taken as reference|||1.20|0.61|
73973680|NCT01223352|147490651|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.71|||||TWO_SIDED|95.0|0.48|1.05||No statistical hypothesis tests were set for this study. The analysis of PK data was carried out descriptively.|||b.i.d. bosentan regimen was taken as reference|||1.05|0.48|
73973681|NCT04623775|147490658|SUPERIORITY||Risk Difference (RD)|-6.5|||||TWO_SIDED|95.0|-16.0|3.0||||||||3.0|-16.0|
73973682|NCT04623775|147490659|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|90.0|0.94|2.05|||Cochran-Mantel-Haenszel|||||2.05|0.94|
73973683|NCT06603766|147490701|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
73973684|NCT06603766|147490702|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
73973685|NCT06603766|147490703|SUPERIORITY|||||||0.008|||||||Chi-squared|||||||0.008
73973686|NCT06603766|147490704|SUPERIORITY|||||||0.032|||||||Chi-squared|||||||0.032
73973687|NCT06603766|147490705|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73973688|NCT06603766|147490706|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73973689|NCT04967599|147490720|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||||||.81
73973690|NCT04967599|147490721|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||||||.46
73973691|NCT04967599|147490722|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|||||||.49
73973692|NCT04967599|147490723|SUPERIORITY|||||||0.59|||||||Kruskal-Wallis|||||||.59
73973693|NCT04967599|147490724|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||.29
73973694|NCT04967599|147490725|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||.49
73973695|NCT04675034|147490739|SUPERIORITY||Combined estimate for LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.416||0.36|TWO_SIDED|95.0|-0.968|0.67|||ANCOVA|Least Square (LS) mean and treatment group difference with associated 95% confidence intervals (CIs) are modelled using ANCOVA on imputed data.||||0.670|-0.968|0.360
73973696|NCT04675034|147490739|SUPERIORITY||Combined estimate for LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.418||0.029|TWO_SIDED|95.0|-1.619|0.027|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.027|-1.619|0.029
73973697|NCT04675034|147490739|SUPERIORITY||Combined estimate for LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.413||0.026|TWO_SIDED|95.0|-1.618|0.009|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.009|-1.618|0.026
73973698|NCT04675034|147490739|SUPERIORITY||Combined estimate for LS mean|-0.59|STANDARD_ERROR_OF_MEAN|0.424||0.083|TWO_SIDED|95.0|-1.423|0.245|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.245|-1.423|0.083
73973699|NCT05275556|147490769|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.0002|TWO_SIDED|95.0|0.07|0.23||Threshold for significance is 0.025.|Poisson Regression|||||0.23|0.07|0.0002
73973700|NCT05275556|147490770|NON_INFERIORITY|Non-inferiority margin is -10%.|Mean Difference (Final Values)|-0.06||||0.09|TWO_SIDED|95.0|-0.15|0.03||Threshold for significance is 0.025.|Resampling based|||||0.03|-0.15|0.09
73973701|NCT05275556|147490771|SUPERIORITY||Difference in percentage|5.5||||0.031|TWO_SIDED|95.0|-0.3|11.2|||Cochran-Mantel-Haenszel|Threshold for significance is 0.025.||||11.2|-0.3|0.031
73973702|NCT05275556|147490772|OTHER||rate|0.58|||||TWO_SIDED|||||||||||||
73973703|NCT05275556|147490773|OTHER|2 sided test for differences between arms|Mean Difference (Final Values)|0.58||||0.169|TWO_SIDED||||||Permutation test|||||||0.169
73973704|NCT05275556|147490774|OTHER||||||||||||||||||Descriptive analysis: 52.4 in Colonoscopy (Standard of Care), 59.6 in CAD-e Device|||
73973705|NCT05275556|147490775|SUPERIORITY||Mean Difference (Net)|4.6||||0.0578|TWO_SIDED|95.0|-0.2|9.4||Nominal p-value.|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.4|-0.2|0.0578
73866959|NCT02262754|147279087|SUPERIORITY_OR_OTHER||Mean Difference (Naproxen-Placebo)|-0.26|||||TWO_SIDED|90.0|-0.7|0.18||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.||0.18|-0.70|
73866960|NCT02262754|147279093|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.23|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.76|0.3||||||The ANCOVA model included treatment as fixed effects.||0.30|-0.76|
73866961|NCT02262754|147279093|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|0.12|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.41|0.65||||||The ANCOVA model included treatment as fixed effects.||0.65|-0.41|
73866962|NCT02262754|147279093|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.35|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.87|0.17||||||The ANCOVA model included treatment as fixed effects.||0.17|-0.87|
73866963|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.08|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.2|0.36||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.36|-0.20|
73866964|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.2|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.48|0.07||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.07|-0.48|
73866965|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.28|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.01|0.56||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.56|0.01|
73866966|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.43|0.34||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.34|-0.43|
73866967|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.24|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.62|0.15||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.15|-0.62|
73866968|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.19|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.19|0.58||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.58|-0.19|
73866969|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.03|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.39|0.45||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.45|-0.39|
73939359|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939360|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73973706|NCT05275556|147490776|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.7813|TWO_SIDED|95.0|-1.5|2.0||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||2.0|-1.5|0.7813
73866970|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.27|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.69|0.16||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.16|-0.69|
73939361|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939362|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73973707|NCT05275556|147490777|SUPERIORITY||Least-squares means|0.11|||||TWO_SIDED|95.0|0.05|0.17||||||||0.17|0.05|
73973708|NCT05275556|147490778|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.0004|TWO_SIDED|95.0|3.7|12.9||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||12.9|3.7|0.0004
73939363|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939364|NCT00833638|147410946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
74030986|NCT00570739|147615640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13||||0.2238|TWO_SIDED|95.0|-1.32|5.58||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||5.58|-1.32|0.2238
74030987|NCT00570739|147615640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.2763|TWO_SIDED|95.0|-1.44|4.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.99|-1.44|0.2763
73939365|NCT00833638|147410946|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for day \<=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.003
73939366|NCT00833638|147410946|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for day \<=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.008
74030988|NCT00570739|147615641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.83|||<|0.0001|TWO_SIDED|95.0|-13.68|-5.98||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-5.98|-13.68|<0.0001
73939367|NCT00833638|147410946|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-value for day \<=1. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.246
73939368|NCT00833638|147410947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.05|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received placebo in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving placebo) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939369|NCT00833638|147410948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.22|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalafil 2.5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 2.5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939370|NCT00833638|147410949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalfil 5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939371|NCT00833638|147410950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.11|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the percentages of successful intercourse attempts exist in participants who received tadalafil 2.5 mg in the double-blind treatment period and did not respond to treatment when comparing their percentage of succesful intercourse attempts between the double-blind treatment period and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
73939372|NCT02959996|147410961|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
73939373|NCT02959996|147410962|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
73939374|NCT02959996|147410963|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
74030989|NCT00570739|147615641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.67||||0.0004|TWO_SIDED|95.0|-13.4|-3.94||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-3.94|-13.40|0.0004
73939375|NCT02962908|147410970|OTHER|Inequality test.||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 and to 42.||||0.45
73939376|NCT02962908|147410970|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 and to 42.||||<0.001
73939377|NCT02962908|147410970|OTHER|inequality test||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 42.||||0.88
73939378|NCT02962908|147410970|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 42.||||<0.001
73939379|NCT02962908|147410970|OTHER|inequality test||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 42.||||0.21
73939380|NCT02962908|147410970|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 42.||||<0.001
73939381|NCT02962908|147410970|OTHER|inequality test||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 42.||||0.77
73939382|NCT02962908|147410970|OTHER|inequality test||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 42.||||0.004
73939383|NCT02962908|147410970|OTHER|inequality test||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 42.||||0.08
73939384|NCT02962908|147410970|OTHER|inequality test||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 42.||||0.38
73939385|NCT02962908|147410970|OTHER|inequality test||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 42.||||0.49
73939386|NCT02962908|147410970|OTHER|inequality test||||||0.156|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 42.||||0.156
73973709|NCT05275556|147490779|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1185|TWO_SIDED|95.0|-1.0|9.1||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.1|-1|0.1185
73973710|NCT05275556|147490780|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.0752|TWO_SIDED|95.0|-0.4|9.2||nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.2|-0.4|0.0752
73939387|NCT02962908|147410970|OTHER|inequality test||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL-2 from day 0 to day 42.||||0.125
73939388|NCT02962908|147410970|OTHER|inequality test||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
73939389|NCT02962908|147410970|OTHER|inequality test||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 42.||||0.72
73939390|NCT02962908|147410970|OTHER|inequality test||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 42.||||0.34
73939391|NCT02962908|147410971|OTHER|inequality test||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 to day 180.||||0.62
73939392|NCT02962908|147410971|OTHER|inequality test||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 to day 180.||||0.030
73939393|NCT02962908|147410971|OTHER|inequality test||||||0.87|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 180.||||0.87
73939394|NCT02962908|147410971|OTHER|inequality test||||||0.075|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 180.||||0.075
73939395|NCT02962908|147410971|OTHER|inequality test||||||0.076|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 180.||||0.076
73939396|NCT02962908|147410971|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 180.||||<0.001
73939397|NCT02962908|147410971|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 180.||||0.91
73939398|NCT02962908|147410971|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 180.||||0.91
73939399|NCT02962908|147410971|OTHER|inequality test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 180.||||0.55
73939400|NCT02962908|147410971|OTHER|inequality test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 180.||||0.55
73939401|NCT02962908|147410971|OTHER|inequality||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 180.||||0.91
73939402|NCT02962908|147410971|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 180.||||0.91
73939403|NCT02962908|147410971|OTHER|inequality test||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL2 from day 0 to day 180.||||0.21
73939404|NCT02962908|147410971|OTHER|inequality test||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL2 from day 0 to day 180.||||0.48
73939405|NCT02962908|147410971|OTHER|inequality test||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 180.||||0.62
73939406|NCT02962908|147410971|OTHER|inequality||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 180.||||0.23
73939407|NCT02962908|147410972|OTHER|inequality test||||||0.8|||||||Chi-squared|||Comparison of CD4+ IFNgamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.80
73939408|NCT02962908|147410972|OTHER|inequality test|||||<|0.001|||||||Fisher Exact|||Comparison of CD4+ IFNgamma responders on day 42. Differences considered significant if p-value \<0.05.||||<0.001
73939409|NCT02962908|147410972|OTHER|inequality test||||||0.23|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.23
73939410|NCT02962908|147410972|OTHER|||||||0.056|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.056
73939411|NCT02962908|147410972|OTHER|inequality test||||||0.74|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.74
73939412|NCT02962908|147410972|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 42. Differences considered significant if p-value \<0.05.||||<0.001
73939413|NCT02962908|147410972|OTHER|inequality test||||||0.34|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.34
73939414|NCT02962908|147410972|OTHER|inequality test||||||0.01|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.010
73939415|NCT02962908|147410972|OTHER|inequality test||||||0.096|||||||Chi-squared|||Comparison of CD4+ IFNgamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.096
73939416|NCT02962908|147410972|OTHER|inequality test||||||0.049|||||||Fisher Exact|||Comparison of CD4+ IFNgamma responders on day 180.Differences considered significant if p-value \<0.05.||||0.049
73939417|NCT02962908|147410972|OTHER|inequality test||||||0.91|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.91
73939418|NCT02962908|147410972|OTHER|||||||0.39|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.39
73939419|NCT02962908|147410972|OTHER|inequality test||||||0.94|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.94
73939420|NCT02962908|147410972|OTHER|inequality test|||||<|0.001|||||||Fisher Exact|||Comparison of CD4+ IL-2 responders on day 180. Differences considered significant if p-value \<0.05.||||<0.001
73939421|NCT02962908|147410972|OTHER|inequality test||||||0.044|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.044
73939422|NCT02962908|147410972|OTHER|inequality test||||||0.98|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.98
73939423|NCT02962908|147410972|OTHER|inequality test||||||0.48|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.48
73939424|NCT02962908|147410972|OTHER|inequality test||||||0.28|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.28
73939425|NCT02962908|147410972|OTHER|inequality test||||||0.7|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.70
73939426|NCT02962908|147410972|OTHER|inequality test||||||0.175|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.175
73939427|NCT02962908|147410972|OTHER|inequality test||||||0.24|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.24
73939428|NCT02962908|147410972|OTHER|inequality test||||||0.8|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.80
73939429|NCT02962908|147410972|OTHER|inequality test||||||0.023|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.023
73939430|NCT02962908|147410972|OTHER|inequality test||||||0.015|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.015
73939431|NCT02962908|147410972|OTHER|inequality test||||||0.81|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.81
73939432|NCT02962908|147410972|OTHER|inequality test||||||0.34|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.34
73939433|NCT02962908|147410972|OTHER|inequality test||||||0.3|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.30
73939434|NCT02962908|147410972|OTHER|inequality test||||||0.105|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.105
73939435|NCT02962908|147410972|OTHER|inequality test||||||0.38|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.38
73939436|NCT02962908|147410972|OTHER|inequality test||||||0.44|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.44
73939437|NCT02962908|147410972|OTHER|inequality test||||||0.58|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.58
73939438|NCT02962908|147410972|OTHER|inequality test||||||0.43|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.43
73939439|NCT02962908|147410973|OTHER|inequality test||||||0.25|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 42||||0.25
73866971|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.3|STANDARD_ERROR_OF_MEAN|0.25||||90.0|-0.12|0.71||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.71|-0.12|
73866972|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.07|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.4|0.55||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.55|-0.40|
73866973|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.84|0.11||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.11|-0.84|
73866974|NCT02262754|147279094|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.44|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.03|0.91||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.91|-0.03|
73866975|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.03|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|-0.03|0.08||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.08|-0.03|
73866976|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|-0.09|0.02||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.02|-0.09|
73866977|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.06|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|0.01|0.12||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.12|0.01|
73866978|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.09|0.1||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.10|-0.09|
73866979|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.15|0.05||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.05|-0.15|
73866980|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.06|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.04|0.15||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.15|-0.04|
73866981|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.12|0.12||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.12|-0.12|
73866982|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.16|0.07||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.07|-0.16|
73866983|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.05|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.07|0.16||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.16|-0.07|
73939440|NCT02962908|147410973|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 42||||1.0
73939441|NCT02962908|147410973|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL-2 at day 42||||1.00
73939442|NCT02962908|147410973|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 42||||1.00
73939443|NCT02962908|147410973|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 42||||<0.001
73939444|NCT02962908|147410973|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 42||||<0.001
73939445|NCT02962908|147410973|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 42||||<0.001
73939446|NCT02962908|147410973|OTHER|inequality test||||||0.31|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 42||||0.31
73939447|NCT02962908|147410973|OTHER|inequality test||||||0.48|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 180||||0.48
74088976|NCT02985879|147731173|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|25.44|=|0.829|TWO_SIDED|95.0|-55.66|44.63|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||44.63|-55.66|=0.829
74088977|NCT02985879|147731173|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-32.9|STANDARD_ERROR_OF_MEAN|25.92|=|0.206|TWO_SIDED|95.0|-83.94|18.23|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||18.23|-83.94|=0.206
73866984|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.01|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.16|0.14||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.14|-0.16|
73866985|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.24|0.05||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.05|-0.24|
73866986|NCT02262754|147279095|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.05|0.23||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.23|-0.05|
73939448|NCT02962908|147410973|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 180||||1.00
73973711|NCT05275556|147490782|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.8194|TWO_SIDED|95.0|-3.2|2.6||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||2.6|-3.2|0.8194
73973712|NCT05275556|147490783|OTHER|Test for difference|Incidence Rate Ratio|1.39||||0.0008|TWO_SIDED|95.0|1.14|1.69||Nominal p-value|Exact poisson|||||1.69|1.14|0.0008
73866987|NCT02262754|147279096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|90.0|0.54|1.73||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.73|0.54|
73866988|NCT02262754|147279096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|90.0|0.81|2.51||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||2.51|0.81|
73866989|NCT02262754|147279096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68|||||TWO_SIDED|90.0|0.39|1.2||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.20|0.39|
73866990|NCT02262754|147279096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|90.0|0.37|1.81||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.81|0.37|
73866991|NCT02262754|147279096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|90.0|0.53|2.35||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||2.35|0.53|
73866992|NCT02262754|147279096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|90.0|0.33|1.6||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.60|0.33|
73866993|NCT02262754|147279102|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.18|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-1.06|0.7||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.70|-1.06|
73866994|NCT02262754|147279102|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.91|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-1.8|-0.03||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.03|-1.80|
73866995|NCT02262754|147279102|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.73|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.15|1.61||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.61|-0.15|
73939449|NCT02962908|147410973|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 180||||1.00
73939450|NCT02962908|147410973|OTHER|inequality test||||||0.59|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 180||||0.59
73939451|NCT02962908|147410973|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 180||||<0.001
73939452|NCT02962908|147410973|OTHER|inequality test||||||0.013|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 180||||0.013
73939453|NCT02962908|147410973|OTHER|inequality|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 180||||<0.001
73939454|NCT02962908|147410973|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 180||||1.00
73939455|NCT02962908|147410973|OTHER|inequality test||||||0.55|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 42||||0.55
73939456|NCT02962908|147410973|OTHER|inequality test||||||0.55|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 42||||0.55
73939457|NCT02962908|147410973|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 42||||1.00
73939458|NCT02962908|147410973|OTHER|inequality test||||||0.29|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 180||||0.29
73939459|NCT02962908|147410973|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 180||||1.00
73939460|NCT02962908|147410973|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 180||||1.00
73973713|NCT04679389|147490792|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
73973714|NCT04679389|147490793|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
73973715|NCT04679389|147490794|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
73973716|NCT04679389|147490795|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
73939461|NCT02962908|147410973|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 180||||1.00
73939462|NCT02962908|147410973|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing CD107a at day 180||||1.00
73973717|NCT04679389|147490798|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
73973718|NCT04679389|147490799|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
73939463|NCT02962908|147410974|OTHER|inequality test||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 42. p\<0.05 considered statistically significant.||||0.59
73939464|NCT02962908|147410974|OTHER|inequality test||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 42. p\<0.05 considered statistically significant.||||0.001
73939465|NCT02962908|147410974|OTHER|inequality test||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 180. p\<0.05 considered statistically significant.||||0.61
73939466|NCT02962908|147410974|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 180. p\<0.05 considered statistically significant.||||<0.001
73939467|NCT02962908|147410975|OTHER|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."||||0.113
73939468|NCT02962908|147410975|OTHER||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."||||<0.001
73939469|NCT02962908|147410975|OTHER|||||||0.399|||||||Chi-squared|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."||||0.399
73939470|NCT02962908|147410975|OTHER||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."||||<0.001
73939471|NCT02962908|147410977|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42 post-vaccination.||||<0.001
73939472|NCT02962908|147410977|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42.||||<0.001
73939473|NCT02962908|147410977|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.||||<0.001
73939474|NCT02962908|147410977|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.||||<0.001
73939475|NCT02962908|147410980|OTHER|||||||0.662|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.||||0.662
73939476|NCT02962908|147410980|OTHER|||||||0.168|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.||||0.168
73939477|NCT02962908|147410981|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||The study was not powered to detected statistical significant differences in this outcome.|||>0.05
73939478|NCT02962908|147410981|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||Study not powered to detect statistically significant differences|||>0.05
73939479|NCT02962908|147410982|OTHER|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison in the duration of symptoms between treatment group and corresponding placebo.||||0.513
73939480|NCT02962908|147410982|OTHER|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of the duration of symptoms between treatment group and corresponding placebo.||||0.578
73973719|NCT04099732|147490800|OTHER||Ratio of geometric means (T/R) %|183.36|||||TWO_SIDED|90.0|164.35|204.56|||||Geometric coefficient of variation (gCV) = 16.5.|Relative bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||204.56|164.35|
73973720|NCT04099732|147490801|OTHER||Ratio of geometric means (T/R) %|174.01|||||TWO_SIDED|90.0|154.73|195.68|||||Geometric coefficient of variation (gCV) = 17.7|Relative bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||195.68|154.73|
73939481|NCT02962908|147410982|OTHER|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison of total symptom score between treatment group and corresponding placebo.||||0.513
73939482|NCT02962908|147410982|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total symptom score between treatment group and corresponding placebo.||||0.200
73939483|NCT02962908|147410982|OTHER|||||||0.658|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.||||0.658
73939484|NCT02962908|147410982|OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.||||0.640
73939485|NCT02962908|147410982|OTHER|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.||||0.127
73939486|NCT02962908|147410982|OTHER|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.||||0.201
73939487|NCT02962908|147410983|OTHER|inequality test||||||0.85|||||||Chi-squared|||comparison between groups on day 42||||0.85
73939488|NCT02962908|147410983|OTHER|inequality test||||||0.042|||||||Fisher Exact|||comparison between groups on day 42||||0.042
73939489|NCT02962908|147410983|OTHER|inequality test||||||0.69|||||||Fisher Exact|||comparison between groups on day 180||||0.69
73939490|NCT02962908|147410983|OTHER|inequality test||||||0.198|||||||Fisher Exact|||comparison between groups on day 180||||0.198
73939491|NCT02962908|147410983|OTHER|inequality test||||||0.092|||||||Chi-squared|||comparison between groups on day 42||||0.092
73939492|NCT02962908|147410983|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||comparison of groups on day 42||||<0.001
73939493|NCT02962908|147410983|OTHER|inequality test||||||0.27|||||||Chi-squared|||comparison of groups on day 180||||0.27
73939494|NCT02962908|147410983|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||comparisons between groups on day 180||||<0.001
73939495|NCT05540522|147411017|OTHER||RVE|34.5|||||TWO_SIDED|95.0|7.4|53.9||||||||53.9|7.4|
73939496|NCT05540522|147411018|OTHER||RVE|-5.8|||||TWO_SIDED|95.0|-47.2|23.8||||||||23.8|-47.2|
73939497|NCT05540522|147411039|OTHER||GMR|1.23|||||TWO_SIDED|95.0|1.1|1.38||||||A/H3N2||1.38|1.10|
73939498|NCT05540522|147411039|OTHER||GMR|1.24|||||TWO_SIDED|95.0|1.1|1.39||||||A/H1N1||1.39|1.10|
73939499|NCT05540522|147411039|OTHER||GMR|0.73|||||TWO_SIDED|95.0|0.67|0.8||||||B/Yamagata||0.80|0.67|
73939500|NCT05540522|147411039|OTHER||GMR|0.3|||||TWO_SIDED|95.0|0.26|0.35||||||B/Victoria||0.35|0.26|
73939501|NCT05540522|147411040|OTHER||GMR|1.65|||||TWO_SIDED|95.0|1.47|1.84||||||A/H3N2||1.84|1.47|
73939502|NCT05540522|147411040|OTHER||GMR|1.71|||||TWO_SIDED|95.0|1.51|1.92||||||A/H1N1||1.92|1.51|
73939503|NCT05540522|147411040|OTHER||GMR|1.04|||||TWO_SIDED|95.0|0.95|1.14||||||B/Yamagata||1.14|0.95|
73939504|NCT05540522|147411040|OTHER||GMR|0.61|||||TWO_SIDED|95.0|0.54|0.69||||||B/Victoria||0.69|0.54|
73939505|NCT05540522|147411041|OTHER||Difference in percentage|11.4|||||TWO_SIDED|95.0|6.4|16.4||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||16.4|6.4|
73939506|NCT05540522|147411041|OTHER||Difference in percentage|13.6|||||TWO_SIDED|95.0|8.6|18.6||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||18.6|8.6|
73939507|NCT05540522|147411041|OTHER||Difference in percentage|-15.3|||||TWO_SIDED|95.0|-19.5|-11.2||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-11.2|-19.5|
73939508|NCT05540522|147411041|OTHER||Difference in percentage|-40.5|||||TWO_SIDED|95.0|-44.7|-36.1||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-36.1|-44.7|
73939509|NCT05540522|147411042|OTHER||Difference in percentage|21.6|||||TWO_SIDED|95.0|16.7|26.5||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||26.5|16.7|
73939510|NCT05540522|147411042|OTHER||Difference in percentage|25.7|||||TWO_SIDED|95.0|20.9|30.4||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||30.4|20.9|
73939511|NCT05540522|147411042|OTHER||Difference in percentage|-2.1|||||TWO_SIDED|95.0|-4.8|0.6||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||0.6|-4.8|
73939512|NCT05540522|147411042|OTHER||Difference in percentage|-22.6|||||TWO_SIDED|95.0|-26.7|-18.5||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-18.5|-26.7|
73939513|NCT05540522|147411043|OTHER||GMR|1.92|||||TWO_SIDED|95.0|1.78|2.07||||||A/H3N2||2.07|1.78|
73939514|NCT05540522|147411043|OTHER||GMR|1.68|||||TWO_SIDED|95.0|1.55|1.82||||||A/H1N1||1.82|1.55|
73939515|NCT05540522|147411043|OTHER||GMR|0.88|||||TWO_SIDED|95.0|0.82|0.94||||||B/Yamagata||0.94|0.82|
73939516|NCT05540522|147411043|OTHER||GMR|0.58|||||TWO_SIDED|95.0|0.53|0.63||||||B/Victoria||0.63|0.53|
73939517|NCT05540522|147411044|OTHER||GMR|2.38|||||TWO_SIDED|95.0|2.23|2.54||||||A/H3N2||2.54|2.23|
73939518|NCT05540522|147411044|OTHER||GMR|2.37|||||TWO_SIDED|95.0|2.22|2.54||||||A/H1N1||2.54|2.22|
73939519|NCT05540522|147411044|OTHER||GMR|1.36|||||TWO_SIDED|95.0|1.29|1.43||||||B/Yamagata||1.43|1.29|
73939520|NCT05540522|147411044|OTHER||GMR|0.76|||||TWO_SIDED|95.0|0.71|0.81||||||B/Victoria||0.81|0.71|
73939521|NCT05540522|147411045|OTHER||Difference in Percentage|26.8|||||TWO_SIDED|95.0|23.7|29.9||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||29.9|23.7|
73939522|NCT05540522|147411045|OTHER||Difference in Percentage|26.9|||||TWO_SIDED|95.0|23.9|29.8||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||29.8|23.9|
73939523|NCT05540522|147411045|OTHER||Difference in Percentage|-3.6|||||TWO_SIDED|95.0|-6.6|-0.6||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-0.6|-6.6|
73939524|NCT05540522|147411045|OTHER||Difference in Percentage|-19.2|||||TWO_SIDED|95.0|-21.9|-16.6||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-16.6|-21.9|
73939525|NCT05540522|147411046|OTHER||Difference in Percentage|37.9|||||TWO_SIDED|95.0|35.2|40.5||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||40.5|35.2|
73866996|NCT02262754|147279102|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.7|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.69|0.29||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.29|-1.69|
73866997|NCT02262754|147279102|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.11|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.11|-2.11|
73866998|NCT02262754|147279102|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.41|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-0.57|1.39||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.39|-0.57|
73939526|NCT05540522|147411046|OTHER||Difference in Percentage|44.9|||||TWO_SIDED|95.0|42.4|47.4||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||47.4|42.4|
73939527|NCT05540522|147411046|OTHER||Difference in Percentage|10.6|||||TWO_SIDED|95.0|8.5|12.8||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||12.8|8.5|
73939528|NCT05540522|147411046|OTHER||Difference in Percentage|-13.8|||||TWO_SIDED|95.0|-16.3|-11.3||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-11.3|-16.3|
73939529|NCT00844857|147411123|SUPERIORITY_OR_OTHER|||||||0.003||||||The a priori threshold for statistical significance was 0.05. Mixed Model Repeated Measures Analysis (MMRM) terms included baseline, country, treatment, visit, and treatment \* visit interaction.|Mixed Models Analysis|||"Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.~A conservative estimate of effect size of 0.4 was used in the sample size estimation for this study. A randomized ratio of 2:1 provided a 90% power with an effect size of 0.4."||||0.003
73939530|NCT00844857|147411124|SUPERIORITY_OR_OTHER|||||||0.035||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.035
73939531|NCT00844857|147411125|SUPERIORITY_OR_OTHER|||||||0.003||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.003
73939532|NCT00844857|147411126|SUPERIORITY_OR_OTHER|||||||0.007||||||The a priori threshold for statistical significance was 0.05. Ordinal Logistic Regression Model terms include baseline CDRS-R, baseline YMRS, and treatment.|Ordinal Logistic Regression|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.007
73939533|NCT00844857|147411127|SUPERIORITY_OR_OTHER|||||||0.527||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment\*visit interaction.|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.||||0.527
73973721|NCT04099732|147490802|OTHER||Ratio of geometric means (T/R) %|119.1|||||TWO_SIDED|90.0|109.84|129.15|||||Geometric coefficient of variation (gCV) = 11.1.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||129.15|109.84|
74030990|NCT00570739|147615641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.09||||0.0004|TWO_SIDED|95.0|-12.5|-3.68||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-3.68|-12.50|0.0004
73866999|NCT02262754|147279102|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.41|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-1.42|0.6||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.60|-1.42|
73939534|NCT00844857|147411128|SUPERIORITY_OR_OTHER|||||||0.03||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment\*visit interaction|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.||||0.030
73939535|NCT00844857|147411129|SUPERIORITY_OR_OTHER|||||||0.002||||||The a priori threshold for statistical significance was 0.05. ANCOVA (analysis of covariance) Model terms included baseline, country, and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.002
73939536|NCT00844857|147411130|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
73939537|NCT00844857|147411131|SUPERIORITY_OR_OTHER|||||||0.309||||||P-value for Suicidal Ideation. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.309
73939538|NCT00844857|147411131|SUPERIORITY_OR_OTHER|||||||0.667||||||P-value for Suicidal Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.667
73973722|NCT04099732|147490803|OTHER||Ratio of geometric means (T/R) %|119.2|||||TWO_SIDED|90.0|107.68|131.94|||||Geometric coefficient of variation (gCV) = 13.9.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||131.94|107.68|
73867000|NCT02262754|147279102|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.27|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-2.28|-0.27||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.27|-2.28|
73939539|NCT00844857|147411131|SUPERIORITY_OR_OTHER|||||||0.309||||||P-value for Suicidal Ideation or Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.309
73939540|NCT00844857|147411132|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
73939541|NCT00844857|147411133|SUPERIORITY_OR_OTHER|||||||0.545||||||P-value for ADHDRS-IV-PI Total Score. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.545
73939542|NCT00844857|147411134|SUPERIORITY_OR_OTHER|||||||0.066||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.066
73939543|NCT00844857|147411135|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
73939544|NCT00844857|147411136|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
73939545|NCT00844857|147411137|SUPERIORITY_OR_OTHER|||||||0.05||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.050
73939546|NCT00844857|147411138|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
73939547|NCT00844857|147411139|SUPERIORITY_OR_OTHER|||||||0.98||||||P-value for Fasting Glucose. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.980
73939548|NCT00844857|147411139|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for Fasting Cholesterol. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
73939549|NCT00844857|147411139|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for Fasting Triglycerides. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
73939550|NCT00844857|147411140|SUPERIORITY_OR_OTHER|||||||0.005||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.005
73939551|NCT00844857|147411141|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
73939552|NCT00844857|147411142|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
73939553|NCT00240487|147411152|NON_INFERIORITY_OR_EQUIVALENCE|The primary outcome variable is the mean PaO2/FiO2 in each group after 8 hours of study participation to determine whether timing of treatment with nitric oxide impacts outcome (immediate treatment versus delayed treatment).|||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Differences in mean PaO2/FiO2 ratios between the two groups will help to determine whether order of therapy (immediate treatment with nitric oxide versus delayed treatment with nitric oxide) impacts outcomes.||||>0.05
73939554|NCT00440531|147411153|SUPERIORITY_OR_OTHER||single-group percentage|75.7||||||95.0|68.0|82.2||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.||82.20|68|
73939555|NCT00440531|147411153|SUPERIORITY_OR_OTHER||single-group percentage|68.0||||||95.0|59.8|75.5||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.||75.50|59.80|
73939556|NCT00440531|147411154|SUPERIORITY_OR_OTHER||Single-Group Percentage|84.0||||||95.0|77.0|89.6||||||No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) for ENGERIX-B™ at 1 month post vaccination 3, among subjects who were seronegative at baseline.||89.60|77|
73939557|NCT00447057|147411158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.0047|TWO_SIDED|95.0|0.438|0.897|||Log Rank|Log-rank test with 1-sided alpha of 0.20||||0.897|0.438|0.0047
73939558|NCT00447057|147411159|SUPERIORITY_OR_OTHER|||||||0.3909|||||||Fisher Exact|||||||0.3909
73939559|NCT00447057|147411160|SUPERIORITY_OR_OTHER|||||||0.1808|||||||Fisher Exact|||||||0.1808
73939560|NCT00447057|147411161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0034|TWO_SIDED|95.0|0.457|0.887||1-sided significance level of 0.20|Log Rank|||||0.887|0.457|0.0034
73939561|NCT00447057|147411162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.019|TWO_SIDED|95.0|0.465|0.981||1-sided significance level of 0.20|Log Rank|||||0.981|0.465|0.0190
73939562|NCT04493216|147411180|OTHER||Differences in percentage of participant|-9.2|||||TWO_SIDED|95.0|-24.0|5.7|||||Differences in percentage of participant = Percentage of participant in GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ABC/3TC or FTC/TAF|||5.7|-24.0|
73939563|NCT04493216|147411180|OTHER||Differences in percentage of participant|-1.0|||||TWO_SIDED|95.0|-13.5|11.6|||||Differences in percentage of participant = Percentage of participant in GSK3640254 150 mg+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF|||11.6|-13.5|
73973723|NCT04099732|147490804|OTHER||Ratio of geometric means (T/R) %|186.38|||||TWO_SIDED|90.0|169.7|204.71|||||Geometric coefficient of variation (gCV) = 14.1.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||204.71|169.70|
73973724|NCT04099732|147490805|OTHER||Ratio of geometric means (T/R) %|120.11|||||TWO_SIDED|90.0|110.78|130.23|||||Geometric coefficient of variation (gCV) = 11.1|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||130.23|110.78|
73973725|NCT05257603|147490806|OTHER||Mean Difference (Net)|4.82|STANDARD_ERROR_OF_MEAN|0.615|<|0.99|TWO_SIDED|95.0|3.24|5.72|||ANOVA|||||5.72|3.24|<0.99
73973726|NCT05257603|147490807|OTHER||||||<|0.29|||||||Chi-squared|||||||<.29
73973727|NCT05257603|147490808|OTHER||||||<|0.99|||||||ANOVA|||A one-way ANOVA was used to compare the mean difference in key presses from time 1 to time 2 between the intervention (RPCW) and Control conditions.||||<0.99
73973728|NCT05257603|147490809|OTHER||||||<|0.45|||||||ANOVA|||||||<0.45
73973729|NCT05257603|147490810|OTHER||||||<|0.1||||||Given the exploratory nature of the analysis we were looking for a trend in improvement in emotion regulation (i.e., p\<.10) following the intervention condition compared to control.|ANOVA|||||||<.10
73973730|NCT05257603|147490811|OTHER||||||<|0.1|||||||ANOVA|||Repeated measure ANOVA was used to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial. The current pilot RCT was not powered to find significant effects.||||<.10
73973731|NCT05257603|147490812|OTHER||||||<|0.1||||||A priori threshold for a trend set at p\<.10 for condition effect (intervention v control).|ANOVA|||An exploratory repeated measures ANOVA with time (4) as the within-subjects variable and condition (2) as the between-subjects variable was conducted to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial. The current pilot RCT was not powered to find significant effects.||||<.10
73973732|NCT05257603|147490813|OTHER||||||<|0.098|||||||ANOVA|||An exploratory repeated measures ANOVA with time (4) as the within-subjects variable and condition (2) as the between-subjects variable was conducted to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial.||||<.098
73973733|NCT05215054|147490824|NON_INFERIORITY|Non-inferiority will be demonstrated if the upper limit of the two-sided 95%CI of the difference of changes from baseline between test device and control is inferior or equal to 0.5.||||||||||||||||Difference of changes from baseline in WSRS score for Gana V versus Sculptra|Non-inferiority will be demonstrated if the upper limit of the two-sided 95%CI of the difference of changes from baseline between test device and control is inferior or equal to 0.5.To assess assay sensitivity, the proportion of responders with Gana V®, defined as improvement of ≥1-grade in the WSRS when compared to D0 pre-injection must be ≥50% at the 6 months visit after baseline.|||
73973734|NCT01651000|147490834|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73973735|NCT01651000|147490835|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73973736|NCT01651000|147490836|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73973737|NCT03636490|147490853|OTHER|We tested an association between change in urinary sodium excretion rate with stress and ratio of awake-to-asleep urinary sodium excretion rate.|unstandardized B coefficients|0.0021||||0.0032||95.0|0.0007|0.0034|||Regression, Linear|Adjusted for age, sex, race, ethnicity, body mass index, mean DBP during the baseline period, and 24-hour creatinine clearance.||||0.0034|0.0007|0.0032
73973738|NCT03636490|147490854|OTHER|We tested an association between ratio of awake-to-asleep urinary sodium excretion rate and SBP dipping.|unstandardized B coefficients|0.8244||||0.037||95.0|0.0487|1.6|||Regression, Linear|Adjusted for age, sex, race, ethnicity, BMI, smoking, alcohol use, glucose, 24-hr sodium and potassium excretion, 24-hr creat clear, and FENa|Data are unstandardized B coefficients (95% CI)|||1.6000|0.0487|0.037
73973739|NCT02246127|147490868|SUPERIORITY||Odds Ratio (OR)|0.65||||0.229|TWO_SIDED|95.0|0.32|1.32|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||1.32|0.32|0.229
73939564|NCT04493216|147411180|OTHER||Differences in percentage of participant|-15.5|||||TWO_SIDED|95.0|-31.2|0.3|||||Differences in percentage of participant = Percentage of participant in GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF|||0.3|-31.2|
73973740|NCT02246127|147490869|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.135|TWO_SIDED|95.0|0.9|2.19|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||2.19|0.90|0.135
73973741|NCT02246127|147490870|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.474|TWO_SIDED|95.0|0.77|1.75|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||1.75|0.77|0.474
73973742|NCT02246127|147490872|SUPERIORITY|||||||0.001|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.001
73973743|NCT02246127|147490874|SUPERIORITY|||||||0.012|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.012
73973744|NCT02246127|147490875|SUPERIORITY|||||||0.001|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.001
73973745|NCT02246127|147490876|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.168|TWO_SIDED|95.0|0.86|2.37|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||2.37|0.86|0.168
73973746|NCT02246127|147490878|SUPERIORITY|||||||0.072|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.072
73939565|NCT02314624|147411248|SUPERIORITY|||||||0.734||||||Analyses were performed on each subscale individually. This is the p-value for the Depression subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.734
73939566|NCT02314624|147411248|SUPERIORITY|||||||0.27||||||Analyses were performed on each subscale individually. This is the p-value for the Anxiety subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used a Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.27
73939567|NCT02314624|147411248|SUPERIORITY|||||||0.75||||||Analyses were performed on each subscale individually. This is the p-value for the Stress subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used a Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.75
73939568|NCT02314624|147411248|SUPERIORITY|||||||0.812||||||Analyses were performed on each subscale individually. This is the p-value for the Suicide subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.812
73939569|NCT02314624|147411249|SUPERIORITY|||||||0.036|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.036
73939570|NCT02314624|147411250|SUPERIORITY|||||||0.664|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.664
73939571|NCT02314624|147411251|SUPERIORITY|||||||0.764|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.764
73939572|NCT02314624|147411252|SUPERIORITY|||||||0.44|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.440
73973747|NCT02246127|147490880|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.079|TWO_SIDED|95.0|0.94|2.73|||Log Rank|||significant differences between both arms is assumed in case p-val \< 0.05||2.73|0.94|0.079
73973748|NCT06097494|147490954|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|1.01|1.15|||||Calculated as the odds of a person diagnosed with vitiligo having with depression versus people not diagnosed with vitiligo|||1.15|1.01|
73973749|NCT06097494|147490955|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|1.09|1.3|||||Calculated as the odds of people diagnosed with vitiligo having anxiety compared to people not diagnosed with vitilligo.|||1.30|1.09|
73867001|NCT02262754|147279102|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.86|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-0.12|1.85||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.85|-0.12|
73973750|NCT06097494|147490956|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|1.03|1.17|||||Calculated as the odds of people diagnosed with vitiligo having anxiety or depression compared to people not diagnosed with vitilligo.|||1.17|1.03|
73973751|NCT06097494|147490957|SUPERIORITY||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|1.26|1.32|||||Adjusted incident rate ratio for increased primary care use was calculated by comparing patients with vitiligo versus matched controls not having vitiligo,using negative binomial regression.|||1.32|1.26|
73973752|NCT06097494|147490959|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.93|1.2|||||Hazard ratios for mental health referrals was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.20|0.93|
73939573|NCT02314624|147411253|SUPERIORITY|||||||0.09|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.09
73939574|NCT02314624|147411254|SUPERIORITY|||||||0.19|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.19
73939575|NCT02314624|147411255|SUPERIORITY|||||||0.15|||||||Chi-squared|GEE Type III chi squared distribution with 1 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.15
73939576|NCT02314624|147411256|SUPERIORITY||||||<|0.001|||||||Chi-squared|GEE Type III chi squared distribution with 1 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||<.001
73939577|NCT02314624|147411257|SUPERIORITY|||||||0.14|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.14
73939578|NCT02314624|147411258|SUPERIORITY|||||||0.22|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.22
73939579|NCT02314624|147411259|SUPERIORITY||||||<|0.001|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||<.001
73939580|NCT02314624|147411260|SUPERIORITY|||||||0.001|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.001
73939581|NCT02314624|147411261|SUPERIORITY|||||||0.99|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.99
73939582|NCT05090709|147411271|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Stiffness values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
73973753|NCT06097494|147490960|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.76|1.15|||||Hazard ratios for unemployment was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.15|0.76|
73973754|NCT06097494|147490961|OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.06|1.24|||||Hazard ratios for time off work was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.24|1.06|
73973755|NCT06097494|147490962|OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.02|1.31|||||Hazard ratios for sleep disturbance was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.31|1.02|
74008401|NCT03627767|147566508|SUPERIORITY||LSM difference|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.7|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-2.2|< 0.0001
73867002|NCT02262754|147279103|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Placebo)|-0.64|||||TWO_SIDED|90.0|-1.63|0.35||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||0.35|-1.63|
73867003|NCT02262754|147279103|SUPERIORITY_OR_OTHER||Mean Difference (Naproxen-Placebo)|-1.43|||||TWO_SIDED|90.0|-2.4|-0.45||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||-0.45|-2.40|
73973756|NCT04602611|147490981|SUPERIORITY||Coefficient of negative binomial model|0.0547||||0.8|TWO_SIDED|95.0|-0.368|0.4773||The a priori threshold for statistical significance was 0.025.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.||0.4773|-0.3680|0.80
73973757|NCT04602611|147490982|SUPERIORITY|||||||0.88||||||The a priori threshold for statistical significance was 0.025.|Fisher Exact|No adjustments were made in this analysis.||The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.|The proportions of evaluable subjects surviving at 6 months were analyzed in a 2x2 contingency table using Fisher's Exact test. In the SOC arm, 52/87(60%) evaluable subjects were alive at 6 months and 35/87 (40%) were not. In the ONN + SOC arm, 58/95 (61%) evaluable subjects were alive at 6 months and 37/95 (39%) were not. The p-value estimated using Fisher's Exact test on this 2x2 contingency table was p=0.88.|||0.88
73973758|NCT04602611|147490983|SUPERIORITY|||||||0.74||||||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Fisher Exact|No adjustments were made in this analysis.|||The proportions of evaluable subjects surviving at 12 months were analyzed in a 2x2 contingency table using Fisher's Exact test. In the SOC arm, 23/87(26%) evaluable subjects were alive at 12 months and 64/87(74%) were not. In the ONN + SOC arm, 28/95 (29%) evaluable subjects were alive at 6 months and 67/95 (71%) were not. The p-value estimated using Fisher's Exact test on this 2x2 contingency table was p=0.74.|||0.74
73973759|NCT04602611|147490984|SUPERIORITY||Coefficient of negative binomial model|0.1574||||0.57|TWO_SIDED|95.0|-0.3905|0.7054||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.7054|-0.3905|0.57
73973760|NCT04602611|147490985|SUPERIORITY||Hazard Ratio (HR)|0.864||||0.45|TWO_SIDED|95.0|0.57|1.309||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Log Rank|Unadjusted log-rank test|The estimated hazard ratio was associated with Oncology Nurse Navigation with reference to Standard of Care; the model was estimated without adjustments (the sole covariate was treatment).|||1.309|0.570|0.45
73973761|NCT04602611|147490986|SUPERIORITY||Coefficient of negative binomial model|-0.4194||||0.21|TWO_SIDED|95.0|-1.0763|0.2374||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.2374|-1.0763|0.21
73973762|NCT04602611|147490987|SUPERIORITY||Odds Ratio (OR)|3.28|||<|0.01|TWO_SIDED|95.0|1.75|6.15||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Logistic|Model was estimated without adjustments (the sole covariate was treatment).|The estimated odds ratio was associated with Oncology Nurse Navigation with reference to Standard of Care.|||6.15|1.75|<0.01
73973763|NCT04602611|147490988|SUPERIORITY||Slope|-2.6939||||0.11|TWO_SIDED|95.0|-5.9538|0.5659||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Linear|Model was estimated without adjustments (sole covariate was treatment; slope was the estimated treatment effect) using 180 degrees of freedom.|The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.5659|-5.9538|0.11
74030991|NCT00570739|147615642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8||||0.0007|TWO_SIDED|95.0|5.87|21.74||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||21.74|5.87|0.0007
74030992|NCT00570739|147615642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.58||||0.0901|TWO_SIDED|95.0|-1.83|24.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||24.99|-1.83|0.0901
74030993|NCT00570739|147615642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.45||||0.0918|TWO_SIDED|95.0|-1.71|22.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a||Baseline to 16 Weeks LOCF||22.62|-1.71|0.0918
73867004|NCT02262754|147279103|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Naproxen)|0.79|||||TWO_SIDED|90.0|-0.22|1.8||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||1.80|-0.22|
73867005|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|-1.52|0.78||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.78|-1.52|
73867006|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.95|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|-2.1|0.2||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.20|-2.10|
73973764|NCT04602611|147490989|SUPERIORITY||Slope|0.1197||||0.09|TWO_SIDED|95.0|-0.0315|0.4378||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Linear|This univariate model was not adjusted for other covariates; this model was estimated using 84 degrees of freedom.|The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.4378|-0.0315|0.09
73973765|NCT04496752|147490995|EQUIVALENCE|Weighted Cohen's kappa statistics were computed between DCTClock-pen and MMSE, and between DCTClock-tablet and MMSE. A TOST (two one-sided test) of equivalence was planned, with a difference in kappa of 0.2 specified a priori as significant.|Difference in Cohen's Kappa|0.07|||||TWO_SIDED|90.0|-0.05|0.19|||||The difference is Cohen's kappa is (tablet - pen). The confidence interval is estimated with a nonparametric bootstrap (5000 samples).|||0.19|-0.05|
73973766|NCT04704869|147491012|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|0.81|
73973767|NCT03662022|147491031|SUPERIORITY||incidence rate ratio|0.95|||<|0.017|TWO_SIDED|98.3|0.4|2.23||The significance level was determined at 0.017, to account for the fact that we made three comparisons, thus conclusions can be drawn by examining if the 98.3% CI for the incidence rate ratio (IRR) contains the critical value of 1.|Mixed Models Analysis|||||2.23|0.40|<0.017
73973768|NCT03662022|147491031|SUPERIORITY||incidence rate ratio|0.8||||0.017|TWO_SIDED|98.3|0.34|1.87|||Mixed Models Analysis|||||1.87|0.34|0.017
73973769|NCT03662022|147491031|SUPERIORITY||incidence rate ratio|0.58|||<|0.017|TWO_SIDED|98.3|0.22|1.56|||Mixed Models Analysis|||||1.56|0.22|<0.017
73973770|NCT04490109|147491034|SUPERIORITY|The ANCOVA model for primary endpoint change from Baseline to Week 4 in average WI-NRS will have treatment group and Baseline weekly average WI-NRS as explanatory variables. Hypothesis will be tested using a Dunnett Testing Method, applying pairwise comparisons of each group to vehicle using a one-sided familywise error rate of 0.10. Treatment effect will be estimated as least squares means using vehicle as reference and adjusted using Dunnett Testing Method and presented with one-sided 90% CI.||||||0.0148|||||||ANCOVA|||Approximately 576 subjects may be enrolled to account for 16.7% drop out rate prior to completing the study. A total of 160 evaluable subjects per group are required to achieve at least 80% power to detect a difference of 0.65 in mean WI-NRS change from Baseline to Week 4 between one of two active doses of B244 and vehicle control when assuming a standard deviation of 2.5 and applying a Dunnett Testing Method at a one-sided familywise error rate of 0.10.||||0.0148
73973771|NCT04490109|147491034|SUPERIORITY|The ANCOVA model for primary endpoint change from Baseline to Week 4 in average WI-NRS will have treatment group and Baseline weekly average WI-NRS as explanatory variables. Hypothesis will be tested using a Dunnett Testing Method, applying pairwise comparisons of each group to vehicle using a one-sided familywise error rate of 0.10. Treatment effect will be estimated as least squares means using vehicle as reference and adjusted using Dunnett Testing Method and presented with one-sided 90% CI.||||||0.0143|||||||ANCOVA|||Approximately 576 subjects may be enrolled to account for 16.7% drop out rate prior to completing the study. A total of 160 evaluable subjects per group are required to achieve at least 80% power to detect a difference of 0.65 in mean WI-NRS change from Baseline to Week 4 between one of two active doses of B244 and vehicle control when assuming a standard deviation of 2.5 and applying a Dunnett Testing Method at a one-sided familywise error rate of 0.10.||||0.0143
73973772|NCT04490109|147491036|SUPERIORITY|||||||0.0205|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0205
73973773|NCT04490109|147491037|SUPERIORITY|||||||0.0044|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0044
73973774|NCT04490109|147491037|SUPERIORITY|||||||0.0077|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0077
73973775|NCT04490109|147491038|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0400
73973776|NCT04490109|147491038|SUPERIORITY|||||||0.0486|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0486
74030994|NCT00570739|147615643|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|15.78||||0.0005|TWO_SIDED|95.0|6.27|25.83||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 8 Weeks||25.83|6.27|0.0005
73867007|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.58|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|90.0|-0.56|1.71||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||1.71|-0.56|
73867008|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-1.02|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-2.06|0.02||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.02|-2.06|
73867009|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.21|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-2.25|-0.17||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.17|-2.25|
73867010|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.19|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-0.82|1.19||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||1.19|-0.82|
73867011|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.77|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-1.39|-0.15||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.15|-1.39|
73867012|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.17|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-0.8|0.45||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.45|-0.80|
73867013|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.6|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-1.21|0.02||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.02|-1.21|
73867014|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.85|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.42|-0.28||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.28|-1.42|
73867015|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.11|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.67|0.46||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.46|-0.67|
73867016|NCT02262754|147279104|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.74|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-1.29|-0.2||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.20|-1.29|
73867017|NCT02262754|147279105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|90.0|0.61|1.58||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||1.58|0.61|
73867018|NCT02262754|147279105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||||TWO_SIDED|90.0|1.33|3.14||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||3.14|1.33|
73867019|NCT02262754|147279105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|||||TWO_SIDED|90.0|0.31|0.74||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||0.74|0.31|
73867020|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.01|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.19|0.2||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.20|-0.19|
73867021|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.34|0.05||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.05|-0.34|
73973777|NCT04490109|147491040|SUPERIORITY|||||||0.0246|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0246
73939583|NCT05090709|147411271|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Stiffness values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
73939584|NCT05090709|147411276|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
73939585|NCT05090709|147411276|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
73939586|NCT05090709|147411281|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Sit-to-stand velocity values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
73939587|NCT05090709|147411281|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Sit-to-stand velocity values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
73939588|NCT05090709|147411286|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
73939589|NCT05090709|147411286|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
73939590|NCT05090709|147411288|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including both time points in the analysis.||||||< 0.05
73939591|NCT05090709|147411288|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including both time points in the analysis.||||||> 0.05
73867022|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.15|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.05|0.35||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.35|-0.05|
73939592|NCT05090709|147411293|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Muscle tone values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
73939593|NCT05090709|147411293|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Muscle tone values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
73939594|NCT05090709|147411298|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
73939595|NCT05090709|147411298|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
73939596|NCT05090709|147411303|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
73939597|NCT05090709|147411303|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
73973778|NCT04490109|147491040|SUPERIORITY|||||||0.0366|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0366
73973779|NCT04490109|147491041|SUPERIORITY|||||||0.0467|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0467
73973780|NCT04490109|147491042|SUPERIORITY|||||||0.0293|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0293
73973781|NCT04490109|147491043|SUPERIORITY|||||||0.0045|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0045
73939598|NCT05090709|147411308|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
73939599|NCT05090709|147411308|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
73939600|NCT05090709|147411313|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
73939601|NCT05090709|147411313|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
73939602|NCT05090709|147411318|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
73939603|NCT05090709|147411318|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
73939604|NCT05090709|147411323|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
73939605|NCT05090709|147411323|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
73939606|NCT03912259|147411324|SUPERIORITY||Difference in Percentage|22.0|||<|0.0001|TWO_SIDED|95.0|11.37|32.65||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|P-value was derived by the Cochran-Mantel-Haenszel test stratified by baseline disease severity (IGA=3 vs. IGA=4).||||32.65|11.37|<.0001
73973782|NCT04490109|147491043|SUPERIORITY|||||||0.0043|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0043
73867023|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.04|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.26|0.18||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.18|-0.26|
73867024|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.15|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.37|0.07||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.07|-0.37|
73867025|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.11|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.1|0.33||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.33|-0.10|
73867026|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.15|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.09|0.38||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.38|-0.09|
73867027|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|0.02|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.21|0.25||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.25|-0.21|
73939607|NCT02131272|147411367|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered fulfilled if the upper bound of the two-sided 95% confidence interval for the difference between detemir and NPH was below or equal to 0.4%. The sample size was set to ensure 80% power for the full analysis set (FAS). However, efficacy conclusions cannot be drawn from the analysis due to low number of subjects included in the trial.|Least squares mean difference|0.17||||0.3075|TWO_SIDED|95.0|-0.74|1.09||p value is reported for 1 sided test|Mixed Models Analysis|||HbA1c measurements were analysed with a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit, age group, prior antidiabetic therapy and interaction between prior antidiabetic therapy and age group as fixed factors and the HbA1c baseline value as covariate. Interactions between visit and all factors and covariates were also included in the model.||1.09|-0.74|0.3075
73939608|NCT01786512|147411396|OTHER||Treatment difference|0.0112|STANDARD_ERROR_OF_MEAN|0.0033||0.0007|TWO_SIDED|95.0|0.0047|0.0176|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.0176|0.0047|0.0007
73939609|NCT01786512|147411396|OTHER||Treatment difference|0.025|STANDARD_ERROR_OF_MEAN|0.0033|<|0.0001|TWO_SIDED|95.0|0.0184|0.0315|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.0315|0.0184|<0.0001
73867028|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.1|0.36||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.36|-0.10|
73939610|NCT01786512|147411397|OTHER||Treatment difference|4.58|STANDARD_ERROR_OF_MEAN|1.56||0.0036|TWO_SIDED|95.0|1.5|7.65|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||7.65|1.50|0.0036
73939611|NCT01786512|147411397|OTHER||Treatment difference|3.63|STANDARD_ERROR_OF_MEAN|1.57||0.0217|TWO_SIDED|95.0|0.53|6.72|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||6.72|0.53|0.0217
73939612|NCT01786512|147411398|OTHER||Treatment difference|-0.079|STANDARD_ERROR_OF_MEAN|0.058||0.1732|TWO_SIDED|95.0|-0.194|0.035|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.035|-0.194|0.1732
73939613|NCT01786512|147411398|OTHER||Treatment difference|-0.179|STANDARD_ERROR_OF_MEAN|0.059||0.0027|TWO_SIDED|95.0|-0.295|-0.062|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.062|-0.295|0.0027
73939614|NCT01786512|147411399|OTHER||Treatment difference|-0.067|STANDARD_ERROR_OF_MEAN|0.051||0.1899|TWO_SIDED|95.0|-0.166|0.033|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.033|-0.166|0.1899
73939615|NCT01786512|147411399|OTHER||Treatment difference|-0.129|STANDARD_ERROR_OF_MEAN|0.052||0.0128|TWO_SIDED|95.0|-0.231|-0.028|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.028|-0.231|0.0128
73939616|NCT01786512|147411400|OTHER||Treatment difference|-1.34|STANDARD_ERROR_OF_MEAN|1.09||0.2177|TWO_SIDED|95.0|-3.47|0.79|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.79|-3.47|0.2177
73939617|NCT01786512|147411400|OTHER||Treatment difference|-2.97|STANDARD_ERROR_OF_MEAN|1.09||0.007|TWO_SIDED|95.0|-5.12|-0.81|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.81|-5.12|0.0070
73939618|NCT01786512|147411401|OTHER||Treatment difference|-822.0|STANDARD_ERROR_OF_MEAN|353.0||0.0205|TWO_SIDED|95.0|-1516.0|-127.0|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-127|-1516|0.0205
73939619|NCT01786512|147411401|OTHER||Treatment difference|-970.0|STANDARD_ERROR_OF_MEAN|357.0||0.0069|TWO_SIDED|95.0|-1672.0|-268.0|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-268|-1672|0.0069
73939620|NCT00605293|147411407|SUPERIORITY_OR_OTHER|||||||0.4778|||||||Fisher Exact|||||||0.4778
73939621|NCT02858050|147411419|OTHER|||||||0.548306|||||||Chi-squared|||||||0.548306
73939622|NCT03561090|147411420|SUPERIORITY||Least squares (LS) mean difference|0.055||||0.6346|TWO_SIDED|95.0|-0.172|0.281|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as least squares mean (LSM) change from baseline at Week 8; IW-3718 - placebo based on an mixed models repeated measures (MMRM) model with week (categorical), treatment group, week-by-treatment group, and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.281|-0.172|0.6346
73939623|NCT03561090|147411421|SUPERIORITY||LS Mean Difference|0.035||||0.7101|TWO_SIDED|95.0|-0.151|0.221|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as LSM change from baseline at Week 8; IW-3718 - placebo based on an MMRM model with week (categorical), treatment group, week-by-treatment group, and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.221|-0.151|0.7101
73939624|NCT03561090|147411422|SUPERIORITY||Difference in percentage of responders|-5.5|||||TWO_SIDED|95.0|-14.7|3.7|||||95% confidence interval (CI) for Difference in Responder Rates is obtained using the Newcombe CI.|||3.7|-14.7|
73939625|NCT03561090|147411422|SUPERIORITY||Odds Ratio (OR)|0.81||||0.2531|TWO_SIDED|95.0|0.56|1.17|||Cochran-Mantel-Haenszel||Odds Ratio for Response (IW-3718 : placebo)|Treatment difference was calculated as the difference in the responder rates at Week 8; IW-3718 - placebo. The 95% CI for the difference in the responder rates was obtained using the Newcombe CI. P value was based on the odds ratio for the response rate (IW-3718:placebo) obtained from the CMH tests controlling for baseline esophagitis status and baseline heartburn severity level (\< 3 vs. ≥ 3).||1.17|0.56|0.2531
73939626|NCT03561090|147411423|SUPERIORITY||Proportion ratio|0.938||||0.7445|TWO_SIDED|95.0|0.636|1.382||Negative binomial model was used to deal with data overdispersion.|Negative binomial model||Proportion Ratio (1500 mg IW-3718 BID + PPI: Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||1.382|0.636|0.7445
74091659|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.36|||<|0.001|TWO_SIDED|95.0|1.06|1.75|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 22F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.75|1.06|<0.001
73939627|NCT03561090|147411423|OTHER|Negative binomial model was used to deal with data overdispersion.|Difference in Proportion Ratio|-0.015|||||TWO_SIDED|95.0|-0.103|0.074|||||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI).|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||0.074|-0.103|
73939628|NCT02163733|147411425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|106.05|||||TWO_SIDED|90.0|94.82|118.6|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. Least squares geometric mean ratio (LSGMR) Fed = 7847, Fasted = 7399.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.||118.60|94.82|
74091660|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.69|1.06|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 33F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.06|0.69|<0.001
73939629|NCT02163733|147411426|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%|Geometric mean ratio|92.75|||||TWO_SIDED|90.0|81.4|105.68|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. LSGMR Fed = 208.0, Fasted = 224.3.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.||105.68|81.40|
73939630|NCT02163733|147411434|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|81.15|||||TWO_SIDED|90.0|57.86|113.83|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 497.6, Fasted = 613.2.|AZ5104||113.83|57.86|
73867029|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.12|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.13|0.38||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.38|-0.13|
73867030|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.21|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.46|0.05||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.05|-0.46|
73867031|NCT02262754|147279106|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.33|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.08|0.58||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.58|0.08|
73939631|NCT02163733|147411434|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|88.21|||||TWO_SIDED|90.0|65.21|119.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 235.0, Fasted = 266.4.|AZ7550||119.32|65.21|
73939632|NCT02163733|147411435|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|76.68|||||TWO_SIDED|90.0|55.31|106.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 9.163, Fasted = 11.95.|AZ5104||106.32|55.31|
73939633|NCT02163733|147411435|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|82.92|||||TWO_SIDED|90.0|60.99|112.74|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 4.236, Fasted = 5.109.|AZ7550||112.74|60.99|
73939634|NCT00713648|147411440|SUPERIORITY_OR_OTHER||Mean (Lambda)|0.048||||||95.0|0.0094|0.2501|||Poisson model (log-link)|The estimated rate was adjusted for age and overdispersion which was estimated by Pearson's chi-square statistic divided by its degrees of freedom.|Mean (Lambda) refer to the estimate of the annualised bleeding rate|||0.2501|0.0094|
73939635|NCT02633800|147411444|OTHER|Both Log-rank test and Cox regression analysis did not adjust stratification factors.|Hazard Ratio (HR)|0.9291||||0.8342|TWO_SIDED|95.0|0.4856|1.7778||Unstratified Log-rank p-value|Log Rank|||Heregulin-high population - Patritumab vs Placebo||1.7778|0.4856|0.8342
73939636|NCT04386096|147411475|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
73939637|NCT04386096|147411477|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Change in Adolescent Pre-Intention Factors||||0.30
73939638|NCT04386096|147411477|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Change in Parent Pre-Intention Factors||||0.71
73939639|NCT04386096|147411478|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Change in Adolescent Intention to take/give ADHD medicine regularly||||0.29
73939640|NCT04386096|147411478|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||Change in Parent Intention to take/give ADHD medicine regularly||||0.19
73939641|NCT04386096|147411479|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
73973783|NCT04490109|147491044|SUPERIORITY|||||||0.0026|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0026
73939642|NCT04386096|147411480|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.81
73973784|NCT04490109|147491044|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0005
73939643|NCT04386096|147411482|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Change in Adolescent: Child Seek||||0.10
73939644|NCT04386096|147411482|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Change in Adolescent: Child Express||||0.51
73939645|NCT04386096|147411482|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||Change in Adolescent: Parent Seek||||0.84
73939646|NCT04386096|147411482|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||Change in Adolescent: Parent Express||||0.93
73939647|NCT04386096|147411482|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Change in Adolescent: Joint/Options||||0.43
73939648|NCT04386096|147411482|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Change in Parent: Child Seek||||0.94
73939649|NCT04386096|147411482|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Change in Parent: Child Express||||0.79
73939650|NCT04386096|147411482|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Change in Parent: Parent Seek||||0.61
73939651|NCT04386096|147411482|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Change in Parent: Parent Express||||0.10
73939652|NCT04386096|147411482|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||Change in Parent: Joint/Options||||0.98
73939653|NCT00868439|147411495|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||< 0.001
73939654|NCT00868439|147411496|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.027|TWO_SIDED||||||Fisher Exact|||||||= 0.027
73939655|NCT00868439|147411497|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.101|TWO_SIDED||||||Fisher Exact|||||||= 0.101
73939656|NCT00868439|147411498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||Fisher Exact|||||||0.022
73939657|NCT00868439|147411499|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.136|TWO_SIDED||||||Fisher Exact|||||||= 0.136
73939658|NCT00868439|147411500|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.015|TWO_SIDED||||||Fisher Exact|||||||= 0.015
73939659|NCT04149405|147411501|OTHER||Mean Difference (Final Values)|0.01|||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||||||<0.01
73939660|NCT04149405|147411502|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
73939661|NCT04149405|147411503|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
73939662|NCT04149405|147411504|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
73939663|NCT04109703|147411505|OTHER|The hypothesis is that the high level pulsed heat group will show statistically more pain relief than the low level steady heat group.|||||<|0.05|||||||Regression, Linear|Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level.||Demographic and clinical characteristics were tabulated by randomization group. The primary outcome was change in pain score from baseline to 30 minutes after treatment ended. Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level. Unadjusted comparisons are also presented. Change in pain scores at each other post baseline time point were similarly analyzed.||||<0.05
73939664|NCT02167074|147411509|OTHER|The chi-square test (with Yates' correction when appropriate) or the Fisher exact test was used to compare the two needle types|||||<|0.05|||||||Chi-squared|||||||<0.05
73939665|NCT05072080|147411551|SUPERIORITY||Mean Difference (Final Values)|96.6|||<|0.0001|TWO_SIDED|95.0|95.0|97.5||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|Day 22||97.5|95.0|<0.0001
73939666|NCT05072080|147411553|SUPERIORITY||GMT Ratio|206.0|||<|0.0001|TWO_SIDED|95.0|183.0|232.0||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo).|Day 22||232|183|<0.0001
73939667|NCT05072080|147411555|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.98|||||TWO_SIDED|95.0|0.85|1.14|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.14|0.85|
73939668|NCT05072080|147411555|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.84|1.12|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.12|0.84|
73939669|NCT05072080|147411555|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.1|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.10|0.82|
73939670|NCT05072080|147411557|SUPERIORITY||Mean Difference (Final Values)|96.0|||<|0.0001|TWO_SIDED|95.0|94.3|96.8||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 15||96.8|94.3|<0.0001
73939671|NCT05072080|147411557|SUPERIORITY||Mean Difference (Final Values)|84.0|||<|0.0001|TWO_SIDED|95.0|81.7|85.6||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 183||85.6|81.7|<0.0001
73939672|NCT05072080|147411557|SUPERIORITY||Mean Difference (Final Values)|46.1|||<|0.0001|TWO_SIDED|95.0|43.8|48.1||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 8||48.1|43.8|<0.0001
73973785|NCT04490109|147491045|SUPERIORITY|||||||0.0348|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0348
73939673|NCT05072080|147411559|SUPERIORITY||GMT Ratio|13.0|||<|0.0001|TWO_SIDED|95.0|11.0|14.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 8||14|11|<0.0001
73939674|NCT05072080|147411559|SUPERIORITY||GMT Ratio|144.0|||<|0.0001|TWO_SIDED|95.0|128.0|162.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 15||162|128|<0.0001
73939675|NCT05072080|147411559|SUPERIORITY||GMT Ratio|41.0|||<|0.0001|TWO_SIDED|95.0|37.0|46.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 183||46|37|<0.0001
73939676|NCT05072080|147411561|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 8||||<0.0001
73939677|NCT05072080|147411561|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 15||||<0.0001
73939678|NCT05072080|147411561|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 22||||<0.0001
73939679|NCT05072080|147411561|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 183||||<0.0001
73939680|NCT05072080|147411563|SUPERIORITY||Mean Difference (Final Values)|90.7|||<|0.0001|TWO_SIDED|95.0|88.7|91.9|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 8||91.9|88.7|<0.0001
73939681|NCT05072080|147411563|SUPERIORITY||Mean Difference (Final Values)|98.7|||<|0.0001|TWO_SIDED|95.0|97.2|99.3||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 15||99.3|97.2|<0.0001
73939682|NCT05072080|147411563|SUPERIORITY||Mean Difference (Final Values)|97.6|||<|0.0001|TWO_SIDED|95.0|95.8|98.5|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 22||98.5|95.8|<0.0001
73939683|NCT05072080|147411563|SUPERIORITY||Mean Difference (Final Values)|96.8|||<|0.0001|TWO_SIDED|95.0|94.8|97.9|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 183||97.9|94.8|<0.0001
73939684|NCT05072080|147411563|SUPERIORITY||Mean Difference (Final Values)|64.8|||<|0.0001|TWO_SIDED|95.0|62.5|66.7|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 8||66.7|62.5|<0.0001
73939685|NCT05072080|147411563|SUPERIORITY||Mean Difference (Final Values)|97.8|||<|0.0001|TWO_SIDED|95.0|96.3|98.4|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 15||98.4|96.3|<0.0001
73939686|NCT05072080|147411563|SUPERIORITY||Mean Difference (Final Values)|97.2|||<|0.0001|TWO_SIDED|95.0|95.5|98.1|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 22||98.1|95.5|<0.0001
73939687|NCT05072080|147411563|SUPERIORITY||Mean Difference (Final Values)|91.4|||<|0.0001|TWO_SIDED|95.0|89.4|92.7|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 183||92.7|89.4|<0.0001
73939688|NCT02395042|147411567|SUPERIORITY||Least Squares Mean Difference|-1.15||||0.142|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.142
73939689|NCT02395042|147411567|SUPERIORITY||Least Squares Mean Difference|-0.92||||0.319|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.319
73939690|NCT02395042|147411568|SUPERIORITY||Least Squares Mean Difference|-1.46||||0.024|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.024
73939691|NCT02395042|147411568|SUPERIORITY||Least Squares Mean Difference|-1.02||||0.137|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.137
73939692|NCT02701985|147411593|OTHER||Difference in Response Rates|4.27||||0.7955|TWO_SIDED|95.0|-20.55|29.08|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 3 point reduction from baseline in ESSDAI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% confidence interval (CI) are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.||29.08|-20.55|0.7955
73939693|NCT02701985|147411594|OTHER||Difference in Response Rates|1.14||||0.9877|TWO_SIDED|95.0|-23.92|26.19|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 1 point reduction from baseline in ESSPRI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% CI are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.||26.19|-23.92|0.9877
73939694|NCT02701985|147411595|SUPERIORITY||Difference in Adjusted Means|-0.13||||0.8905|TWO_SIDED|95.0|-2.04|1.78|||Mixed Model for Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||1.78|-2.04|0.8905
73939695|NCT02701985|147411596|SUPERIORITY||Difference in Adjusted Means|-0.22||||0.6077|TWO_SIDED|95.0|-1.08|0.64|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||0.64|-1.08|0.6077
73939696|NCT02701985|147411597|SUPERIORITY||Difference in Adjusted Means|-2.06||||0.2846||95.0|-5.87|1.75|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable||1.75|-5.87|0.2846
73939697|NCT02701985|147411598|SUPERIORITY||Difference in Adjusted Means|-0.33||||0.8134||95.0|-2.43|3.08|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable||3.08|-2.43|0.8134
73939698|NCT02701985|147411602|SUPERIORITY||Median Difference (Final Values)|0.87||||0.4266||95.0|-1.3|3.03|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||3.03|-1.30|0.4266
73939699|NCT02701985|147411603|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6429||95.0|-0.21|0.34|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||0.34|-0.21|0.6429
73939700|NCT01640808|147411613|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.351|TWO_SIDED|95.0|0.72|1.124||A two-sided significance level was set at 0.05. Adjustment of multiplicity considering interim analysis is conducted by the Lan DeMets' method of α consumption function.|Log Rank|||||1.124|0.720|0.351
73973786|NCT04490109|147491045|SUPERIORITY|||||||0.0173|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0173
73939701|NCT01640808|147411614|SUPERIORITY||Hazard Ratio (HR)|0.875||||0.222|TWO_SIDED|95.0|0.706|1.085||A two-sided significance level was set at 0.05.|Log Rank|||||1.085|0.706|0.222
73939702|NCT01640808|147411615|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.279|TWO_SIDED|95.0|0.703|1.108||A two-sided significance level was set at 0.05.|Log Rank|||||1.108|0.703|0.279
73939703|NCT00234065|147411628|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% CI limit for the HR of cilostazol to aspirin was 1.33 (4/3) or lower , cilostazol would be non-inferior to aspirin.|Hazard Ratio, log|0.743||||0.0357|TWO_SIDED|95.0|0.564|0.981||The log-rank test was used to verify the superiority of CLZ to ASA only if non-inferiority was verified. The adjusted significance level for the superiority test of the endpoint was set at 0.0471 (two-tailed) according to the O'Brien-Fleming method.|Log Rank|||Statistical Analysis 1 for Number of Patients With First Occurrence of Stroke||0.981|0.564|0.0357
73939704|NCT00234065|147411629|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.88||||0.4189|TWO_SIDED|95.0|0.645|1.2|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||1.200|0.645|0.4189
73973787|NCT04490109|147491046|SUPERIORITY|||||||0.0228|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0228
73973788|NCT04490109|147491046|SUPERIORITY|||||||0.0015|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0015
73973789|NCT04490109|147491047|SUPERIORITY|||||||0.0003|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0003
73973790|NCT04490109|147491048|SUPERIORITY|||||||0.0195|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0195
73973791|NCT04490109|147491049|SUPERIORITY|||||||0.0365|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0365
73973792|NCT04490109|147491050|SUPERIORITY|||||||0.0086|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0086
73973793|NCT04490109|147491050|SUPERIORITY|||||||0.0035|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0035
73973794|NCT04490109|147491051|SUPERIORITY|||||||0.0074|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0074
73973795|NCT04490109|147491051|SUPERIORITY|||||||0.0008|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0008
73973796|NCT04024059|147491098|SUPERIORITY||Odds Ratio (OR)|1.737|||=|0.22|TWO_SIDED|95.0|0.719|4.195|||Regression, Logistic|||||4.195|0.719|=0.22
73973797|NCT04024059|147491098|SUPERIORITY||Odds Ratio (OR)|1.035|||=|0.938|TWO_SIDED|95.0|0.435|2.461|||Regression, Logistic|||||2.461|0.435|=0.938
73973798|NCT04024059|147491099|SUPERIORITY||Odds Ratio (OR)|1.783|||=|0.202|TWO_SIDED|95.0|0.733|4.336|||Regression, Logistic|||||4.336|0.733|=0.202
73973799|NCT04024059|147491099|SUPERIORITY||Odds Ratio (OR)|1.38|||=|0.474|TWO_SIDED|95.0|0.571|3.336|||Regression, Logistic|||||3.336|0.571|=.474
73973800|NCT04024059|147491100|SUPERIORITY||Odds Ratio (OR)|0.669|||=|0.328|TWO_SIDED|95.0|0.299|1.497|||Regression, Logistic|||||1.497|0.299|=0.328
73973801|NCT04024059|147491100|SUPERIORITY||Odds Ratio (OR)|0.724|||=|0.435|TWO_SIDED|95.0|0.322|1.627|||Regression, Logistic|||||1.627|0.322|=0.435
73973802|NCT05541484|147491107|OTHER|Spearman's ρ given non-normal variable distributions|||||<|0.0001||||||Spearman's ρ given non-normal variable distributions|Wilcoxon (Mann-Whitney)|||||||< 0.0001
73939705|NCT00234065|147411630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.4582|TWO_SIDED|95.0|0.675|1.194|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||1.194|0.675|0.4582
73939706|NCT00234065|147411631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.072||||0.86|TWO_SIDED|95.0|0.497|2.313|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||2.313|0.497|0.8600
73939707|NCT00234065|147411632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.799||||0.0437|TWO_SIDED|95.0|0.643|0.994|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||0.994|0.643|0.0437
73939708|NCT00234065|147411633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.458||||0.0004|TWO_SIDED|95.0|0.296|0.711|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||0.711|0.296|0.0004
73973803|NCT05954546|147491123|OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.62|1.72|||||Hazard ratio (HR) was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Encorafenib+Binimetinib (RWD) relative to Encorafenib+Binimetinib (CTD) (reference).||1.72|0.62|
73973804|NCT03547271|147491130|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>1/1.5 for all 4 serogroups.|GMT ratio|0.69|||||TWO_SIDED|95.0|0.565|0.842|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup A||0.842|0.565|
73867032|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.17|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.42|0.08||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.08|-0.42|
73973805|NCT03547271|147491130|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|GMT ratio|4.73|||||TWO_SIDED|95.0|4.0|5.58|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup C||5.58|4.00|
73939709|NCT00126438|147411634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.001|TWO_SIDED|95.0|0.18|0.73||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.73|0.18|0.001
73973806|NCT03547271|147491130|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|Slope|1.54|||||TWO_SIDED|95.0|1.33|1.78|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup W||1.78|1.33|
74030995|NCT00570739|147615643|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.07||||0.0011|TWO_SIDED|95.0|6.33|26.02||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks||26.02|6.33|0.0011
74030996|NCT00570739|147615643|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|14.33||||0.0009|TWO_SIDED|95.0|5.11|23.84||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF||23.84|5.11|0.0009
73939710|NCT00126438|147411634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.001|TWO_SIDED|95.0|0.18|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.72|0.18|0.001
73939711|NCT00126438|147411634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.001|TWO_SIDED|95.0|0.17|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.72|0.17|0.001
73939712|NCT00570674|147411641|OTHER||||||<|0.01|||||||Sign test|||||||<0.01
73973807|NCT03547271|147491130|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|GMT ratio|1.78|||||TWO_SIDED|95.0|1.55|2.04|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup Y||2.04|1.55|
73973808|NCT03547271|147491131|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|-12.2|||||TWO_SIDED|95.0|-17.74|-6.56|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup A||-6.56|-17.74|
73973809|NCT03547271|147491131|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|6.89|||||TWO_SIDED|95.0|4.44|9.62|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup C||9.62|4.44|
73939713|NCT00570674|147411642|OTHER||||||<|0.01|||||||Sign test|||||||<0.01
73939714|NCT00570674|147411643|OTHER|||||||0.52|||||||Sign test|||||||0.52
73939715|NCT00570674|147411644|OTHER|||||||0.39|||||||Sign test|||||||0.39
73939716|NCT00160680|147411652|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|||=|0.667|TWO_SIDED|95.0|-0.96|1.5|||ANCOVA|||||1.50|-0.96|=0.667
73939717|NCT02450331|147411671|SUPERIORITY||Hazard Ratio (HR)|0.892||||0.2446|TWO_SIDED|95.0|0.735|1.081|||Log Rank|||||1.081|0.735|0.2446
73939718|NCT02450331|147411672|SUPERIORITY||Hazard Ratio (HR)|0.897||||0.3172|TWO_SIDED|95.0|0.726|1.109|||Log Rank|||Stratified analysis based on PDL1 status, tumor stage after resection, and nodal status.||1.109|0.726|0.3172
73939719|NCT02450331|147411673|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.836||||0.2235|TWO_SIDED|95.0|0.626|1.116|||Log Rank|||||1.116|0.626|0.2235
73939720|NCT02450331|147411674|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.918||||0.4291|TWO_SIDED|95.0|0.743|1.134|||Log Rank|||||1.134|0.743|0.4291
73939721|NCT02450331|147411675|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.879||||0.1994|TWO_SIDED|95.0|0.722|1.07|||Log Rank|||||1.070|0.722|0.1994
73867033|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.62|-0.12||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.12|-0.62|
73867034|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.05|0.45||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.45|-0.05|
73867035|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.08|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.38|0.21||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.38|
73867036|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.29|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.58|0.01||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.01|-0.58|
73867037|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.49||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.49|-0.09|
73867038|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.36|0.21||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.36|
73867039|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.38|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.67|-0.1||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.10|-0.67|
73867040|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.31|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.03|0.59||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.59|0.03|
73867041|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.11|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.42|0.21||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.42|
73867042|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.43|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.75|-0.12||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.12|-0.75|
73867043|NCT02262754|147279107|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.33|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.02|0.63||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.63|0.02|
73867044|NCT02262754|147279108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|90.0|0.46|1.56||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||1.56|0.46|
73867045|NCT02262754|147279108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43|||||TWO_SIDED|90.0|0.23|0.81||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||0.81|0.23|
73867046|NCT02262754|147279108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||||TWO_SIDED|90.0|1.06|3.65||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||3.65|1.06|
73867047|NCT00006400|147279111|SUPERIORITY|The primary analysis was done using an intention-to-treat principle.||||||0.21||||||The spleen endpoint was to be tested at an overall alpha = 0.04. Originally there was a second primary outcome to be tested at alpha = 0.01, but this outcome was dropped.|Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or decreased to absent) and not worsening (from decreased to decreased, normal to normal, or decreased to normal) as measured by splenic uptake on a technetium-99m (99mTc) sulfur colloid liver-spleen scan. Children with missing data or absent spleen function at baseline were excluded from the analysis (26 subjects from hydroxyurea and 23 subjects from placebo group were excluded).||||0.21
73867048|NCT00006400|147279112|SUPERIORITY|||||||0.93||||||This was originally a second primary outcome to be tested at alpha = 0.01, but was later dropped from the protocol. We analyzed the available data.|ANOVA|||The change from baseline to exit as measured by DTPA GFR were compared between treatment groups.||||0.93
74091661|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.78|1.18|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 8. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.18|0.78|<0.001
73867049|NCT00006400|147279113|SUPERIORITY|||||||0.43||||||All secondary outcomes were tested at alpha=0.01|ANOVA|||The change from baseline to exit as measured by GFR (calculated using Shwartz formula) were compared between treatment groups.||||0.43
73939722|NCT03148470|147411693|OTHER|||||||0.932||||||This p-value refers to the effect of stimulation (cTBS vs iTBS).|Mixed Models Analysis|||||||0.932
73939723|NCT03148470|147411694|OTHER|||||||0.642|||||||Mixed Models Analysis|||||||0.642
73939724|NCT01992380|147411712|OTHER||ICC|0.971|||||TWO_SIDED|95.0|0.935|0.988|||||Assessed the agreement between the test and retest imaging of the combination VOI SUVr|Intraclass correlation coefficient \[ICC(2,1)\] analysis from Shrout and Fleiss||0.988|0.935|
73939725|NCT01992380|147411713|OTHER||ICC|0.968|||||TWO_SIDED|95.0|0.926|0.986|||||Assessed the agreement between the test and retest imaging of the combination VOI SUVr|Intraclass correlation coefficient \[ICC(2,1)\] analysis from Shrout and Fleiss||0.986|0.926|
73939726|NCT01175850|147411725|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Z-test|Z-test of two proportions was used to compare treatment groups for all randomized subjects.||||||<0.001
73939727|NCT01175850|147411726|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73939728|NCT01175850|147411727|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73939729|NCT01175850|147411728|SUPERIORITY_OR_OTHER|||||||0.926|TWO_SIDED||||||Chi-squared|||||||0.926
73939730|NCT01175850|147411729|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73939731|NCT01175850|147411730|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73939732|NCT01175850|147411731|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||Chi-squared|||||||0.859
73939733|NCT01175850|147411732|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
73939734|NCT01175850|147411733|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED||||||Chi-squared|||||||0.096
74030997|NCT00570739|147615644|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.29||||0.6523|TWO_SIDED|95.0|-17.5|10.32||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks||10.32|-17.50|0.6523
73939735|NCT01175850|147411734|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73939736|NCT01175850|147411735|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED||||||Chi-squared|||||||0.121
73939737|NCT01175850|147411736|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
73939738|NCT01175850|147411737|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73939739|NCT01175850|147411738|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Chi-squared|||||||0.095
73939740|NCT01175850|147411739|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Chi-squared|||||||0.590
73939741|NCT01175850|147411740|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED||||||Chi-squared|||||||0.302
73939742|NCT01175850|147411741|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED||||||Chi-squared|||||||0.111
73939743|NCT01175850|147411742|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Chi-squared|||||||0.103
73939744|NCT01175850|147411743|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
73939745|NCT03901326|147411745|OTHER|||||||0.05|||||||Chi-squared|||Rate of ICA without obstructive CAD or intervention within 90 days||||0.05
73939746|NCT03901326|147411745|OTHER||||||<|0.001|||||||Chi-squared|||Rate of patients underwent revascularization||||<0.001
73939747|NCT03901326|147411746|OTHER||Hazard Ratio (HR)|0.88||||0.8|TWO_SIDED|95.0|0.59|1.3|||Regression, Cox|||||1.30|0.59|0.80
73939748|NCT03901326|147411747|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
73939749|NCT03901326|147411748|OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
73939750|NCT01814371|147411750|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.757|||||||Fisher Exact|||||||0.757
73939751|NCT01814371|147411751|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
73939752|NCT01814371|147411752|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.687|||||||Fisher Exact|||||||0.687
73939753|NCT01814371|147411753|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
73939754|NCT01814371|147411754|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.811|||||||Fisher Exact|||||||0.811
73939755|NCT01814371|147411755|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.004|||||||Fisher Exact|||||||0.004
73939756|NCT01814371|147411756|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.006|||||||Fisher Exact|||||||0.006
73939757|NCT01814371|147411757|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.05|||||||Fisher Exact|||||||0.050
73939758|NCT01814371|147411758|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.007|||||||Fisher Exact|||||||0.007
73939759|NCT01814371|147411759|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.005|||||||Fisher Exact|||||||0.005
73939760|NCT01814371|147411760|EQUIVALENCE|testing equivalence of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
73939761|NCT01814371|147411761|EQUIVALENCE|testing equivalence of before and after decolonization protocol.||||||0.84|||||||Chi-squared|||||||0.84
73939762|NCT01814371|147411763|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.381|||||||Fisher Exact|||||||0.381
73939763|NCT01814371|147411764|EQUIVALENCE|testing equivalence of individualized approach compared to household approach.||||||0.143|||||||Fisher Exact|||||||0.143
73939764|NCT01692782|147411765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||||TWO_SIDED||||||Mixed Models Analysis|||The 4 mg and 8 mg SEP 225289 groups were compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||
74030998|NCT00570739|147615644|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.38||||0.3934|TWO_SIDED|95.0|-17.51|8.77||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF||8.77|-17.51|0.3934
74030999|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.9838|TWO_SIDED|95.0|-8.66|8.84||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles||8.84|-8.66|0.9838
74031000|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.7157|TWO_SIDED|95.0|-6.73|9.79||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles||9.79|-6.73|0.7157
74031001|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|||<|0.0001|TWO_SIDED|95.0|1.25|3.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles||3.63|1.25|<0.0001
74031002|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39|||<|0.0001|TWO_SIDED|95.0|1.27|3.51||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles||3.51|1.27|<0.0001
74031003|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.04||||0.0577|TWO_SIDED|95.0|-0.17|10.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles||10.24|-0.17|0.0577
74031004|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.24||||0.039|TWO_SIDED|95.0|0.27|10.22||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles||10.22|0.27|0.0390
74031005|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.49||||0.0044|TWO_SIDED|95.0|-12.61|-2.37||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||-2.37|-12.61|0.0044
74031006|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.24||||0.0118|TWO_SIDED|95.0|-11.09|-1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||-1.40|-11.09|0.0118
73867050|NCT00006400|147279114|SUPERIORITY|||||||0.48||||||All secondary outcomes were to be tested at alpha = 0.01|ANOVA|||The change in GFR from baseline to exit were compared between treatment groups. GFR was calculated using new Schwartz formula.||||0.48
73939765|NCT01692782|147411765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38||||0.076|TWO_SIDED||||||Mixed Models Analysis|P-values of SEP 225289 4 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.||The 4 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||0.076
74031007|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-110.6||||0.0293|TWO_SIDED|95.0|-209.9|-11.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-11.3|-209.9|0.0293
74031008|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-112.7||||0.0202|TWO_SIDED|95.0|-207.6|-17.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-17.8|-207.6|0.0202
73867051|NCT03208088|147279128|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|95.0|0.1|11.6|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 1 - Control.|||11.6|0.1|
73939766|NCT01692782|147411765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.88||||0.019|TWO_SIDED|||||p-value of SEP 225289 8 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.|Mixed Models Analysis|||The 8 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||0.019
74031009|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.9629|TWO_SIDED|95.0|-15.2|14.5|||ANCOVA|||Intermediate Density Lipoprotein (LDL) Particles||14.5|-15.2|0.9629
74031010|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.7485|TWO_SIDED|95.0|-16.5|11.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein (LDL) Particles||11.9|-16.5|0.7485
74031011|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.6||||0.1007|TWO_SIDED|95.0|-139.7|12.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||12.5|-139.7|0.1007
74031012|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.8||||0.0768|TWO_SIDED|95.0|-134.6|6.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||6.9|-134.6|0.0768
74031013|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.7||||0.4143|TWO_SIDED|95.0|-162.7|67.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||67.3|-162.7|0.4143
74031014|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.9||||0.402|TWO_SIDED|95.0|-157.1|63.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||63.3|-157.1|0.4020
73867052|NCT03208088|147279128|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-4.0|8.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 2 - Control.|||8.1|-4.0|
73867053|NCT03208088|147279129|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-7.5|4.6|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 3 - Control.|||4.6|-7.5|
73939767|NCT03252587|147411771|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0006|TWO_SIDED|95.0|1.5|5.1|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||5.1|1.5|0.0006
73939768|NCT03252587|147411771|SUPERIORITY||Odds Ratio (OR)|1.9||||0.021|TWO_SIDED|95.0|1.0|3.4|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.4|1.0|0.0210
73939769|NCT03252587|147411771|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0781|TWO_SIDED|95.0|0.8|2.9|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||2.9|0.8|0.0781
73939770|NCT03252587|147411772|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0011|TWO_SIDED|95.0|1.4|4.8|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||4.8|1.4|0.0011
73973810|NCT03547271|147491131|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|2.07|||||TWO_SIDED|95.0|-0.49|4.7|||||95% CI of the difference was calculated from the Wilson score method without continuity correction|Statistical analysis for Serogroup W||4.70|-0.49|
73973811|NCT03547271|147491131|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|3.01|||||TWO_SIDED|95.0|0.34|5.77|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup Y||5.77|0.34|
74031015|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.6378|TWO_SIDED|95.0|-29.1|17.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||17.9|-29.1|0.6378
73867054|NCT03208088|147279129|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean|-3.4|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-9.0|2.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 4 - Control.|||2.3|-9.0|
73867055|NCT02577016|147279130|SUPERIORITY||Difference in least squares means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.05|-0.62|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-0.62|-1.05|<0.001
73867056|NCT02577016|147279133|SUPERIORITY||Difference in least squares means|-42.5|||<|0.001|TWO_SIDED|95.0|-53.7|-31.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-31.2|-53.7|<0.001
73867057|NCT02577016|147279134|SUPERIORITY||Difference in least squares means|-67.0|||<|0.001|TWO_SIDED|95.0|-84.0|-50.0|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-50.0|-84.0|<0.001
73867058|NCT02577016|147279135|SUPERIORITY||Difference in least squares means|-11.2|||<|0.001|TWO_SIDED|95.0|-17.2|-5.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-5.2|-17.2|<0.001
73939771|NCT03252587|147411772|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0434|TWO_SIDED|95.0|0.9|3.1|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.1|0.9|0.0434
73939772|NCT03252587|147411772|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0439|TWO_SIDED|95.0|0.9|3.1|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||3.1|0.9|0.0439
73973812|NCT04835363|147491151|SUPERIORITY|||||||0.029|||||||ANOVA|||||||0.029
73973813|NCT04835363|147491152|SUPERIORITY|||||||0.148|||||||ANOVA|||||||0.148
73973814|NCT04835363|147491153|SUPERIORITY|||||||0.012|||||||ANOVA|||||||0.012
73973815|NCT04835363|147491154|SUPERIORITY|||||||0.078|||||||ANOVA|||||||0.078
73973816|NCT04835363|147491155|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
73939773|NCT03252587|147411773|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0012|TWO_SIDED|95.0|1.4|5.1|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||5.1|1.4|0.0012
73939774|NCT03252587|147411773|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0795|TWO_SIDED|95.0|0.8|3.0|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.0|0.8|0.0795
73939775|NCT03252587|147411773|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0673|TWO_SIDED|95.0|0.9|3.2|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||3.2|0.9|0.0673
73939776|NCT03252587|147411774|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0002|TWO_SIDED|95.0|1.9|8.5|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||8.5|1.9|0.0002
73939777|NCT03252587|147411774|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0371|TWO_SIDED|95.0|0.9|4.5|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||4.5|0.9|0.0371
73939778|NCT03252587|147411774|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0168|TWO_SIDED|95.0|1.1|5.1|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||5.1|1.1|0.0168
73939779|NCT03252587|147411775|SUPERIORITY||Odds Ratio (OR)|10.5||||0.0006|TWO_SIDED|95.0|2.5|43.0|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||43.0|2.5|0.0006
73939780|NCT03252587|147411775|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0058|TWO_SIDED|95.0|1.5|22.0|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||22.0|1.5|0.0058
73973817|NCT04835363|147491156|SUPERIORITY|||||||0.797|||||||ANOVA|||||||0.797
73973818|NCT04835363|147491157|SUPERIORITY|||||||0.358|||||||ANOVA|||||||0.358
73867059|NCT02126839|147279136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.02|STANDARD_ERROR_OF_MEAN|4.52|<|0.0001|TWO_SIDED|95.0|16.1|33.94|||mixed model repeated measures analysis|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.||||33.94|16.10|<0.0001
73939781|NCT03252587|147411775|SUPERIORITY||Odds Ratio (OR)|8.2||||0.0009|TWO_SIDED|95.0|2.2|31.0|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||31.0|2.2|0.0009
73939782|NCT03252587|147411776|SUPERIORITY||Adjusted Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.04||0.0131|TWO_SIDED|95.0|-4.4|-0.3|||Longitudinal Repeated Measures|||Tender BMS-986165 3 mg vs Placebo||-0.3|-4.4|0.0131
73939783|NCT03252587|147411776|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.4156|TWO_SIDED|95.0|-2.3|1.8|||Longitudinal Repeated Measures|||Tender BMS-986165 6 mg vs Placebo||1.8|-2.3|0.4156
73939784|NCT03252587|147411776|SUPERIORITY||Adjusted Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.09||0.0151|TWO_SIDED|95.0|-4.5|-0.2|||Longitudinal Repeated Measures|||Tender BMS-986165 12 mg vs Placebo||-0.2|-4.5|0.0151
73939785|NCT03252587|147411776|SUPERIORITY||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0029|TWO_SIDED|95.0|-2.2|-0.4|||Longitudinal Repeated Measures|||Swollen BMS-986165 3 mg vs Placebo||-0.4|-2.2|0.0029
73939786|NCT03252587|147411776|SUPERIORITY||Adjusted Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.46||0.0516|TWO_SIDED|95.0|-1.6|0.2|||Longitudinal Repeated Measures|||Swollen BMS-986165 6 mg vs Placebo||0.2|-1.6|0.0516
73939787|NCT03252587|147411776|SUPERIORITY||Adjusted Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.48||0.0298|TWO_SIDED|95.0|-1.8|0.0|||Longitudinal Repeated Measures|||Swollen BMS-986165 12 mg vs Placebo||0.0|-1.8|0.0298
73939788|NCT03252587|147411776|SUPERIORITY||Adjusted Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.0|-0.5|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 3 mg vs Placebo||-0.5|-2.0|0.0010
73973819|NCT04835363|147491158|SUPERIORITY|||||||0.055|||||||ANOVA|||||||0.055
73973820|NCT04835363|147491159|SUPERIORITY|||||||0.496|||||||ANOVA|||||||0.496
74031016|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.5528|TWO_SIDED|95.0|-29.1|15.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||15.6|-29.1|0.5528
73939789|NCT03252587|147411776|SUPERIORITY||Adjusted Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.0343|TWO_SIDED|95.0|-1.5|0.1|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 6 mg vs Placebo||0.1|-1.5|0.0343
73939790|NCT03252587|147411776|SUPERIORITY||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.42||0.005|TWO_SIDED|95.0|-1.9|-0.3|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 12 mg vs Placebo||-0.3|-1.9|0.0050
73973821|NCT04835363|147491160|SUPERIORITY|||||||0.241|||||||ANOVA|||||||0.241
73973822|NCT04835363|147491161|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
73973823|NCT04835363|147491162|SUPERIORITY|||||||0.019|||||||ANOVA|||||||0.019
73973824|NCT04835363|147491163|SUPERIORITY|||||||0.141|||||||ANOVA|||ENGAGEMENT STRATEGIES||||0.141
73973825|NCT04835363|147491163|SUPERIORITY|||||||0.496|||||||ANOVA|||DISENGAGEMENT STRATEGIES||||0.496
73867060|NCT02126839|147279137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|76.33|STANDARD_ERROR_OF_MEAN|14.47|<|0.0001|TWO_SIDED|95.0|47.76|104.91|||mixed model repeated measures|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.||||104.91|47.76|<0.0001
73867061|NCT00422383|147279162|SUPERIORITY_OR_OTHER||Weighted Difference|-0.01||||0.8156|TWO_SIDED|95.0|-0.13|0.1|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, rheumatoid factor (RF) status, and treatment.|||0.10|-0.13|0.8156
73867062|NCT00422383|147279162|SUPERIORITY_OR_OTHER||Weighted Difference|0.07||||0.2419|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, RF status, and treatment.|||0.19|-0.05|0.2419
73939791|NCT03945188|147411802|SUPERIORITY||Risk Difference (RD)|19.75|||<|0.001|TWO_SIDED|95.0|12.88|26.63|||Cochran-Mantel-Haenszel|||||26.63|12.88|<0.001
73939792|NCT03945188|147411803|SUPERIORITY||Risk Difference (RD)|25.39|||<|0.001|TWO_SIDED|95.0|18.42|32.36|||Cochran-Mantel-Haenszel|||||32.36|18.42|<0.001
73973826|NCT04159519|147491166|OTHER|Mixed model for repeated measure (MMRM) with fixed effects for treatment arm, visit, baseline value, and treatment-by-visit interaction with an unstructured covariance structure.|Least square mean difference|0.1062|||||TWO_SIDED|95.0|-0.0485|0.2609||||||Comparison with reference arm||0.2609|-0.0485|
73939793|NCT03945188|147411804|SUPERIORITY||Risk Difference (RD)|21.18|||<|0.001|TWO_SIDED|95.0|13.03|29.32|||Cochran-Mantel-Haenszel|||||29.32|13.03|<0.001
73939794|NCT03945188|147411805|SUPERIORITY||Risk Difference (RD)|26.69|||<|0.001|TWO_SIDED|95.0|18.99|34.39|||Cochran-Mantel-Haenszel|||||34.39|18.99|<0.001
73939795|NCT03945188|147411806|SUPERIORITY||Risk Difference (RD)|24.55|||<|0.001|TWO_SIDED|95.0|15.46|33.63|||Cochran-Mantel-Haenszel|||||33.63|15.46|<0.001
73939796|NCT03945188|147411807|SUPERIORITY||Risk Difference (RD)|24.89|||<|0.001|TWO_SIDED|95.0|16.17|33.6|||Cochran-Mantel-Haenszel|||||33.60|16.17|<0.001
73939797|NCT03945188|147411808|SUPERIORITY||Risk Difference (RD)|16.88|||<|0.001|TWO_SIDED|95.0|10.78|22.98|||Cochran-Mantel-Haenszel|||||22.98|10.78|<0.001
73939798|NCT03945188|147411809|SUPERIORITY||Risk Difference (RD)|18.39|||<|0.001|TWO_SIDED|95.0|11.39|25.39|||Cochran-Mantel-Haenszel|||||25.39|11.39|<0.001
73939799|NCT03945188|147411810|SUPERIORITY||Risk Difference (RD)|25.39|||<|0.001|TWO_SIDED|95.0|18.42|32.36|||Cochran-Mantel-Haenszel|||||32.36|18.42|<0.001
73939800|NCT03945188|147411811|SUPERIORITY||Risk Difference (RD)|15.84|||<|0.001|TWO_SIDED|95.0|10.66|21.03|||Cochran-Mantel-Haenszel|||||21.03|10.66|<0.001
73939801|NCT03945188|147411812|SUPERIORITY||Risk Difference (RD)|28.27|||<|0.001|TWO_SIDED|95.0|18.51|38.02|||Cochran-Mantel-Haenszel|||||38.02|18.51|<0.001
73973827|NCT04159519|147491167|OTHER|Comparison|Least square mean difference|-0.0343|||||TWO_SIDED|95.0|-0.2527|0.1841|||Mixed model for repeated measure (MMRM)|MMRM with fixed effects for treatment arm, visit, baseline value, and treatment-by-visit interaction with an unstructured covariance structure.||Comparison with reference arm||0.1841|-0.2527|
73939802|NCT03945188|147411813|SUPERIORITY||Risk Difference (RD)|24.93|||<|0.001|TWO_SIDED|95.0|15.79|34.07|||Cochran-Mantel-Haenszel|||||34.07|15.79|<0.001
73939803|NCT03945188|147411814|SUPERIORITY||Risk Difference (RD)|26.16|||<|0.001|TWO_SIDED|95.0|17.48|34.84|||Cochran-Mantel-Haenszel|||||34.84|17.48|<0.001
73939804|NCT03945188|147411815|SUPERIORITY||Risk Difference (RD)|11.32|||<|0.001|TWO_SIDED|95.0|6.49|16.14|||Cochran-Mantel-Haenszel|||||16.14|6.49|<0.001
73939805|NCT03945188|147411816|SUPERIORITY||Risk Difference (RD)|10.23|||<|0.001|TWO_SIDED|95.0|4.73|15.73|||Cochran-Mantel-Haenszel|||||15.73|4.73|<0.001
73939806|NCT03945188|147411817|SUPERIORITY||Risk Difference (RD)|20.39|||<|0.001|TWO_SIDED|95.0|13.79|26.98|||Cochran-Mantel-Haenszel|||||26.98|13.79|<0.001
73939807|NCT03945188|147411818|SUPERIORITY||Risk Difference (RD)|9.16|||<|0.001|TWO_SIDED|95.0|4.93|13.38|||Cochran-Mantel-Haenszel|||||13.38|4.93|<0.001
73939808|NCT03945188|147411819|SUPERIORITY||Risk Difference (RD)|6.49|||=|0.049|TWO_SIDED|95.0|0.02|12.95|||Cochran-Mantel-Haenszel|||Week 2||12.95|0.02|=0.049
73939809|NCT03945188|147411819|SUPERIORITY||Risk Difference (RD)|15.03|||<|0.001|TWO_SIDED|95.0|7.32|22.74|||Cochran-Mantel-Haenszel|||Week 4||22.74|7.32|<0.001
74088978|NCT02985879|147731174|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|3.88|=|0.304|TWO_SIDED|95.0|-3.65|11.65|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||11.65|-3.65|=0.304
73973828|NCT02765412|147491183|OTHER|multilevel model|Odds Ratio (OR)|0.67||||0.081|TWO_SIDED|95.0|0.58|0.78||Two-sided test; the a priori threshold being 0.05|Regression, Logistic|Adjusts for age, gender, race, comorbidities, implementation group, travel distance, and VAMC indicator|OR corresponding to the interaction between implementation group and lung cancer risk, a ratio of odds ratios. The OR for screening based on lung cancer risk in the SI group versus the OR for screening based on lung cancer risk in the II group|||0.78|0.58|0.081
73939810|NCT03945188|147411819|SUPERIORITY||Risk Difference (RD)|16.85|||<|0.001|TWO_SIDED|95.0|8.06|25.63|||Cochran-Mantel-Haenszel|||Week 8||25.63|8.06|<0.001
73939811|NCT03945188|147411819|SUPERIORITY||Risk Difference (RD)|21.66|||<|0.001|TWO_SIDED|95.0|12.71|30.61|||Cochran-Mantel-Haenszel|||Week 16||30.61|12.71|<0.001
73939812|NCT03945188|147411819|SUPERIORITY||Risk Difference (RD)|23.74|||<|0.001|TWO_SIDED|95.0|14.98|32.51|||Cochran-Mantel-Haenszel|||Week 20||32.51|14.98|<0.001
73939813|NCT03945188|147411819|SUPERIORITY||Risk Difference (RD)|21.04|||<|0.001|TWO_SIDED|95.0|11.83|30.24|||Cochran-Mantel-Haenszel|||Week 24||30.24|11.83|<0.001
73939814|NCT03945188|147411819|SUPERIORITY||Risk Difference (RD)|25.82|||<|0.001|TWO_SIDED|95.0|17.08|34.56|||Cochran-Mantel-Haenszel|||Week 32||34.56|17.08|<0.001
73939815|NCT03945188|147411819|SUPERIORITY||Risk Difference (RD)|23.47|||<|0.001|TWO_SIDED|95.0|14.8|32.14|||Cochran-Mantel-Haenszel|||Week 40||32.14|14.80|<0.001
73973829|NCT02765412|147491184|OTHER||Median Difference (Net)|-0.15||||0.35|TWO_SIDED|95.0|-0.16|0.46||Two-sided test; the a priori threshold being 0.05|t-test, 2 sided||Satisfaction rating on a scale of 0 to 10; Difference is Arm 1 - Arm 2|Simple t-test comparing mean satisfaction ratings between arms||0.46|-0.16|0.35
73939816|NCT03945188|147411819|SUPERIORITY||Risk Difference (RD)|26.37|||<|0.001|TWO_SIDED|95.0|17.92|34.82|||Cochran-Mantel-Haenszel|||Week 48||34.82|17.92|<0.001
73939817|NCT03945188|147411820|SUPERIORITY||Risk Difference (RD)|3.59|||=|0.057|TWO_SIDED|95.0|-0.11|7.3|||Cochran-Mantel-Haenszel|||Week 2||7.30|-0.11|=0.057
73939818|NCT03945188|147411820|SUPERIORITY||Risk Difference (RD)|6.88|||=|0.007|TWO_SIDED|95.0|1.86|11.9|||Cochran-Mantel-Haenszel|||Week 4||11.90|1.86|=0.007
73939819|NCT03945188|147411820|SUPERIORITY||Risk Difference (RD)|10.14|||=|0.001|TWO_SIDED|95.0|4.09|16.2|||Cochran-Mantel-Haenszel|||Week 8||16.20|4.09|=0.001
73939820|NCT03945188|147411820|SUPERIORITY||Risk Difference (RD)|16.36|||<|0.001|TWO_SIDED|95.0|9.89|22.83|||Cochran-Mantel-Haenszel|||Week 12||22.83|9.89|<0.001
73939821|NCT03945188|147411820|SUPERIORITY||Risk Difference (RD)|15.37|||<|0.001|TWO_SIDED|95.0|9.23|21.52|||Cochran-Mantel-Haenszel|||Week 16||21.52|9.23|<0.001
73939822|NCT03945188|147411820|SUPERIORITY||Risk Difference (RD)|17.8|||<|0.001|TWO_SIDED|95.0|11.85|23.75|||Cochran-Mantel-Haenszel|||Week 20||23.75|11.85|<0.001
73939823|NCT03945188|147411820|SUPERIORITY||Risk Difference (RD)|14.24|||<|0.001|TWO_SIDED|95.0|7.45|21.04|||Cochran-Mantel-Haenszel|||Week 24||21.04|7.45|<0.001
73939824|NCT03945188|147411820|SUPERIORITY||Risk Difference (RD)|20.03|||<|0.001|TWO_SIDED|95.0|14.25|25.81|||Cochran-Mantel-Haenszel|||Week 32||25.81|14.25|<0.001
73939825|NCT03945188|147411820|SUPERIORITY||Risk Difference (RD)|15.13|||<|0.001|TWO_SIDED|95.0|8.91|21.35|||Cochran-Mantel-Haenszel|||Week 40||21.35|8.91|<0.001
73939826|NCT03945188|147411820|SUPERIORITY||Risk Difference (RD)|17.52|||<|0.001|TWO_SIDED|95.0|12.16|22.87|||Cochran-Mantel-Haenszel|||Week 48||22.87|12.16|<0.001
73939827|NCT03945188|147411820|SUPERIORITY||Risk Difference (RD)|19.86|||<|0.001|TWO_SIDED|95.0|13.75|25.98|||Cochran-Mantel-Haenszel|||Week 52||25.98|13.75|<0.001
73939828|NCT03945188|147411821|SUPERIORITY||Risk Difference (RD)|4.83|||=|0.336|TWO_SIDED|95.0|-5.01|14.68|||Cochran-Mantel-Haenszel|||Week 2||14.68|-5.01|=0.336
73939829|NCT03945188|147411821|SUPERIORITY||Risk Difference (RD)|17.11|||<|0.001|TWO_SIDED|95.0|7.06|27.15|||Cochran-Mantel-Haenszel|||Week 4||27.15|7.06|<0.001
73939830|NCT03945188|147411821|SUPERIORITY||Risk Difference (RD)|20.17|||<|0.001|TWO_SIDED|95.0|10.15|30.19|||Cochran-Mantel-Haenszel|||Week 8||30.19|10.15|<0.001
73939831|NCT03945188|147411821|SUPERIORITY||Risk Difference (RD)|23.44|||<|0.001|TWO_SIDED|95.0|13.45|33.43|||Cochran-Mantel-Haenszel|||Week 12||33.43|13.45|<0.001
73939832|NCT03945188|147411821|SUPERIORITY||Risk Difference (RD)|25.25|||<|0.001|TWO_SIDED|95.0|15.67|34.83|||Cochran-Mantel-Haenszel|||Week 16||34.83|15.67|<0.001
73939833|NCT03945188|147411821|SUPERIORITY||Risk Difference (RD)|29.2|||<|0.001|TWO_SIDED|95.0|19.77|38.64|||Cochran-Mantel-Haenszel|||Week 20||38.64|19.77|<0.001
73939834|NCT03945188|147411821|SUPERIORITY||Risk Difference (RD)|26.08|||<|0.001|TWO_SIDED|95.0|16.47|35.69|||Cochran-Mantel-Haenszel|||Week 24||35.69|16.47|<0.001
73939835|NCT03945188|147411821|SUPERIORITY||Risk Difference (RD)|28.68|||<|0.001|TWO_SIDED|95.0|19.35|38.02|||Cochran-Mantel-Haenszel|||Week 32||38.02|19.35|<0.001
73939836|NCT03945188|147411821|SUPERIORITY||Risk Difference (RD)|28.43|||<|0.001|TWO_SIDED|95.0|19.3|37.55|||Cochran-Mantel-Haenszel|||Week 40||37.55|19.30|<0.001
73939837|NCT03945188|147411821|SUPERIORITY||Risk Difference (RD)|29.59|||<|0.001|TWO_SIDED|95.0|20.55|38.64|||Cochran-Mantel-Haenszel|||Week 48||38.64|20.55|<0.001
73939838|NCT03945188|147411821|SUPERIORITY||Risk Difference (RD)|26.43|||<|0.001|TWO_SIDED|95.0|17.18|35.68|||Cochran-Mantel-Haenszel|||Week 52||35.68|17.18|<0.001
73939839|NCT03945188|147411822|SUPERIORITY||Risk Difference (RD)|5.93|||=|0.24|TWO_SIDED|95.0|-3.96|15.81|||Cochran-Mantel-Haenszel|||Week 2||15.81|-3.96|=0.240
73939840|NCT03945188|147411822|SUPERIORITY||Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|95.0|7.48|27.53|||Cochran-Mantel-Haenszel|||Week 4||27.53|7.48|<0.001
73939841|NCT03945188|147411822|SUPERIORITY||Risk Difference (RD)|20.93|||<|0.001|TWO_SIDED|95.0|10.92|30.94|||Cochran-Mantel-Haenszel|||Week 8||30.94|10.92|<0.001
73939842|NCT03945188|147411822|SUPERIORITY||Risk Difference (RD)|24.13|||<|0.001|TWO_SIDED|95.0|14.15|34.1|||Cochran-Mantel-Haenszel|||Week 12||34.10|14.15|<0.001
73939843|NCT03945188|147411822|SUPERIORITY||Risk Difference (RD)|24.51|||<|0.001|TWO_SIDED|95.0|14.89|34.13|||Cochran-Mantel-Haenszel|||Week 16||34.13|14.89|<0.001
73939844|NCT03945188|147411822|SUPERIORITY||Risk Difference (RD)|29.57|||<|0.001|TWO_SIDED|95.0|20.13|39.01|||Cochran-Mantel-Haenszel|||Week 20||39.01|20.13|<0.001
73939845|NCT03945188|147411822|SUPERIORITY||Risk Difference (RD)|26.45|||<|0.001|TWO_SIDED|95.0|16.88|36.02|||Cochran-Mantel-Haenszel|||Week 24||36.02|16.88|<0.001
73939846|NCT03945188|147411822|SUPERIORITY||Risk Difference (RD)|29.35|||<|0.001|TWO_SIDED|95.0|20.01|38.68|||Cochran-Mantel-Haenszel|||Week 32||38.68|20.01|<0.001
73939847|NCT03945188|147411822|SUPERIORITY||Risk Difference (RD)|28.83|||<|0.001|TWO_SIDED|95.0|19.71|37.95|||Cochran-Mantel-Haenszel|||Week 40||37.95|19.71|<0.001
73939848|NCT03945188|147411822|SUPERIORITY||Risk Difference (RD)|30.0|||<|0.001|TWO_SIDED|95.0|20.97|39.03|||Cochran-Mantel-Haenszel|||Week 48||39.03|20.97|<0.001
73973830|NCT04244175|147491198|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|0.11|||=|0.986|TWO_SIDED|90.0|-10.38|10.61|||ANCOVA||CVL-865 25 mg BID - Placebo|CVL-865 25 mg BID vs Placebo||10.61|-10.38|=0.986
73973831|NCT04244175|147491198|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|1.42|||=|0.823|TWO_SIDED|90.0|-9.04|11.87|||ANCOVA||CVL-865 7.5 mg BID - Placebo|CVL-865 7.5 mg BID vs Placebo||11.87|-9.04|=0.823
73939849|NCT03945188|147411822|SUPERIORITY||Risk Difference (RD)|26.84|||<|0.001|TWO_SIDED|95.0|17.6|36.07|||Cochran-Mantel-Haenszel|||Week 52||36.07|17.60|<0.001
73973832|NCT04244175|147491198|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|0.76|||=|0.888|TWO_SIDED|90.0|-8.23|9.76|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo|CVL-865 7.5 mg BID / 25 mg BID vs Placebo||9.76|-8.23|=0.888
73973833|NCT04244175|147491199|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|4.9|||||TWO_SIDED|90.0|-12.0|19.3||||||CVL-865 25 mg BID vs Placebo||19.3|-12.0|
73867063|NCT00422383|147279165|SUPERIORITY_OR_OTHER|||||||0.7127|TWO_SIDED|||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA|||||||0.7127
73939850|NCT03945188|147411823|SUPERIORITY||Risk Difference (RD)|23.05|||<|0.001|TWO_SIDED|95.0|10.2|35.9|||Cochran-Mantel-Haenszel|||||35.90|10.20|<0.001
73939851|NCT03945188|147411824|SUPERIORITY||Risk Difference (RD)|31.86|||<|0.001|TWO_SIDED|95.0|18.45|45.28|||Cochran-Mantel-Haenszel|||||45.28|18.45|<0.001
73939852|NCT01515410|147411825|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.86||||0.0471||95.0|-13.62|-0.09||This p-value indicates statistical significance at the 0.05 level.|ANCOVA|No subjects early-terminated from the study.||"Percent OFF Time (%)"||-0.09|-13.62|0.0471
73939853|NCT01618162|147411865|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.02|||<|0.001|TWO_SIDED|95.0|-1.18|-0.87|||ANCOVA|||Superiority of IDegLira versus placebo therapy would be concluded if the 95% CI for the treatment differences for change in HbA1c lied entirely below 0%; implying that the two-sided p-value calculated by the ANCOVA model for testing the hypothesis of no difference between treatments was less than 5%.||-0.87|-1.18|< 0.001
73939854|NCT00989768|147411898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_DEVIATION|0.36|<|0.0001||95.0|||||t-test, 2 sided|||In this study the null hypothesis was that BoNT-A1 had the same effect (halus)than the BoNT-A2.||||<0.0001
73939855|NCT00989768|147411899|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
73939856|NCT00989768|147411900|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||||||0.61
73939857|NCT00989768|147411901|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
73939858|NCT02192502|147411902|NON_INFERIORITY|The non-inferiority delta of a ratio of geometric means is 1.15.|Geometric mean ratio|0.91||||0.15|TWO_SIDED|95.0|0.57|1.44|||generalized linear model|This analysis used linear mixed model with repeated measurements with an unstructured correlation structure.||Assuming that NGAL values follow a log normal distribution as in previous studies with a coefficient of variation of 25%, we need 52 patients per group to have 90% power at the 0.025 significance level to be able to claim non-inferiority of HES to albumin using a non-inferiority delta of a ratio of geometric means of 1.15. After Adjusting for the interim monitoring and five potential dropouts and five pilot patients (which were not included in the analyses), we planned to enroll 140 patients||1.44|0.57|0.15
73939859|NCT02192502|147411903|NON_INFERIORITY|the delta for non-inferiority is 1.15|Risk Ratio (RR)|2.78||||0.92|TWO_SIDED|95.0|0.64|12.1|||Chi-squared|||||12.1|0.64|0.92
73939860|NCT02192502|147411904|NON_INFERIORITY|the non-inferiority delta was 1.15|geometric mean ratio|0.45||||0.002|TWO_SIDED|5.0|0.21|0.95|||Regression, Linear|IL-18 was log-transformed||||0.95|0.21|0.002
73939861|NCT02192502|147411905|NON_INFERIORITY|the delta for non-inferiority is 1.15|geometric mean ratio|0.98||||0.31|TWO_SIDED|95.0|0.45|2.1|||Regression, Linear|IL-18 was log-transformed||||2.10|0.45|0.31
73939862|NCT02192502|147411906|NON_INFERIORITY|The non-inferiority delta was 1.15|Risk Ratio (RR)|0.8|||<|0.001|TWO_SIDED|95.0|0.61|1.03|||Chi-squared|||||1.03|0.61|<0.001
73939863|NCT02046980|147411917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39||||0.02839|TWO_SIDED|95.0|1.58|7.31|||Regression, Logistic|||||7.31|1.58|0.02839
73939864|NCT02046980|147411917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67||||0.0366|TWO_SIDED|95.0|1.25|5.67|||Regression, Logistic|||||5.67|1.25|0.0366
73939865|NCT01994954|147411934|SUPERIORITY||||||<|0.03||||||A two-sided P-value of 0.05 or less was interpreted as a statistically significant result.|t-test, 2 sided|||The trial was designed to have 97% power at a type I error rate of 5% to detect a 25% intervention effect with respect to the primary outcome. this was done using an independent sample t-test. P-value was calculated, and a p-value of 0.05 or less was interpreted as statistically significant result.||||<0.03
73973834|NCT04244175|147491199|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|1.4|||||TWO_SIDED|90.0|-16.1|16.2||||||CVL-865 7.5 mg BID vs Placebo||16.2|-16.1|
73973835|NCT04244175|147491199|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|3.2|||||TWO_SIDED|90.0|-11.4|15.8||||||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||15.8|-11.4|
73973836|NCT04244175|147491200|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.27|||=|0.587|TWO_SIDED|90.0|0.616|2.618|||Regression, Logistic|||CVL-865 25 mg BID vs Placebo||2.618|0.616|=0.587
73973837|NCT04244175|147491200|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.303|||=|0.554|TWO_SIDED|90.0|0.624|2.723|||Regression, Logistic|||CVL-865 7.5 mg BID vs Placebo||2.723|0.624|=0.554
73973838|NCT04244175|147491200|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.286|||=|0.513|TWO_SIDED|90.0|0.684|2.42|||Regression, Logistic|||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||2.420|0.684|=0.513
73973839|NCT04244175|147491201|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||>|0.999|||||||Fisher's exact test|||CVL-865 25 mg BID vs Placebo||||>0.999
73973840|NCT04244175|147491201|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||=|0.618|||||||Fisher's exact test|||CVL-865 7.5 mg BID vs Placebo||||=0.618
73867064|NCT00422383|147279165|SUPERIORITY_OR_OTHER|||||||0.1018|TWO_SIDED|||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA|||||||0.1018
73939866|NCT01994954|147411935|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Power calculations were based on the primary analysis (t-test comparing changes). A sample size of 130 would have given 80% power, with 0.05 two sided type 1 error rate, to detect a 20% absolute difference in emotional role limitation on the PedsQL v2.0, which we considered to be statistically significant.||||0.38
73973841|NCT04244175|147491201|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||=|0.422|||||||Fisher's exact test|||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||||=0.422
73973842|NCT04244175|147491203|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.5|||=|0.021|TWO_SIDED|90.0|-0.8|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||-0.1|-0.8|=0.021
73973843|NCT04244175|147491203|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.2|||=|0.342|TWO_SIDED|90.0|-0.5|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.1|-0.5|=0.342
73973844|NCT04244175|147491203|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.059|TWO_SIDED|90.0|-0.6|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||0.0|-0.6|=0.059
73973845|NCT04244175|147491203|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.5|||=|0.04|TWO_SIDED|90.0|-0.9|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||-0.1|-0.9|=0.040
73973846|NCT04244175|147491203|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.152|TWO_SIDED|90.0|-0.8|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.1|-0.8|=0.152
73973847|NCT04244175|147491203|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.044|TWO_SIDED|90.0|-0.8|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||-0.1|-0.8|=0.044
73973848|NCT04244175|147491203|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.199|TWO_SIDED|90.0|-0.7|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||0.1|-0.7|=0.199
73867065|NCT00422383|147279166|SUPERIORITY_OR_OTHER|||||||0.5029|TWO_SIDED|||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel|||||||0.5029
73867066|NCT00422383|147279166|SUPERIORITY_OR_OTHER|||||||0.0495|TWO_SIDED|||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel|||||||0.0495
73867067|NCT00516165|147279204|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kaplan Meier|||||||0.05
73939867|NCT00675766|147411939|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.69 to 1.38. Range of z-scores at Year 1 follow-up: -1.28 to 1.36.||Repeated Measures ANOVA with overall neurocognitive performance at baseline and follow-up, computed as z-scored derived composite score of 14 individual neuropsychological measures assessing attention, processing speed, visuospatial skills, language, memory, executive function and motor skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.001
73939868|NCT00675766|147411939|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.96 to 1.89. Range of z-scores at Year 1 follow-up: -1.89 to 1.77.||Repeated Measures ANOVA with processing speed at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing speed of cognitive information processing, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||<0.005
73939869|NCT00675766|147411939|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 2.44. Range of z-scores at Year 1 follow-up: -1.82 to 2.00.||Repeated Measures ANOVA with attention at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing attentional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||< 0.01
73939870|NCT00675766|147411939|SUPERIORITY_OR_OTHER||||||<|0.07|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.76 to 0.95. Range of z-scores at Year 1 follow-up: -1.18 to 0.84.||Repeated Measures ANOVA with executive function at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing working memory, set shifting, mental flexibility and problem solving, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||<0.07
73939871|NCT00675766|147411939|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 1.94. Range of z-scores at Year 1 follow-up: -1.83 to 2.11.||Repeated Measures ANOVA with language at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal fluency and naming skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.09
73939872|NCT00675766|147411939|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.00 to 1.68. Range of z-scores at Year 1 follow-up: -2.33 to 1.90.||Repeated Measures ANOVA with memory at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal and nonverbal learning and memory, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||.72
73939873|NCT00675766|147411939|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.04 to 2.51. Range of z-scores at Year 1 follow-up: -2.21 to 2.24.||Repeated Measures ANOVA with visuospatial skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing visuospatial and visuoconstructional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.65
73939874|NCT00675766|147411939|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -4.04 to 1.33. Range of z-scores at Year 1 follow-up: -1.24 to 2.37.||Repeated Measures ANOVA with motor skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing fine motor speed and dexterity, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.79
73939875|NCT00675766|147411939|SUPERIORITY_OR_OTHER|||||||0.044|ONE_SIDED||||||Fisher Exact|One-sided Fisher's exact test with 1 degree of freedom.||Fisher's exact test compared the frequency of older and younger HIV+ adults who converted from neurocognitively intact to neurocognitively impaired on memory over a one year time period. We hypothesized that the older group would exhibit a greater proportion of individuals who declined during this interim.||||.044
73939876|NCT02363946|147412056|OTHER||alpha estimate|9.557|STANDARD_ERROR_OF_MEAN|0.037|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370||||
73939877|NCT02363946|147412056|OTHER||beta estimate|1.173|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|1.128|1.218|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370|R-square (r\^2)=0.98|1.218|1.128|
73939878|NCT02363946|147412056|OTHER||alpha estimate|9.824|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP||||
73939879|NCT02363946|147412056|OTHER||beta estimate|1.103|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|1.054|1.153|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP|R-square (r\^2)=0.98|1.153|1.054|
73939880|NCT02363946|147412058|OTHER||alpha estimate|11.274|STANDARD_ERROR_OF_MEAN|0.057|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370||||
73867068|NCT00516165|147279205|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||||||<0.05
73867069|NCT00516165|147279206|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||||||<0.05
73867070|NCT00516165|147279207|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
73867071|NCT00516165|147279208|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
73867072|NCT00516165|147279209|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
73867073|NCT03738618|147279216|OTHER||Treatment difference|43.3|||<|0.001|TWO_SIDED|95.0|36.5|47.6|||Fisher Exact||95% exact Agresti-Min confidence intervals.|||47.6|36.5|<0.001
73867074|NCT03738618|147279217|OTHER||Treatment difference|22.0|||<|0.001|TWO_SIDED|95.0|14.9|25.7|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Ongoing Pregnancy Rate in the Fresh Cycle||25.7|14.9|<0.001
73939881|NCT02363946|147412058|OTHER||beta estimate|1.181|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|1.112|1.249|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370|R-square (r\^2)=0.96|1.249|1.112|
73939882|NCT02363946|147412058|OTHER||alpha estimate|12.133|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP||||
73939883|NCT02363946|147412058|OTHER||beta estimate|1.147|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|1.08|1.215|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP|R-square (r\^2)=0.96|1.215|1.080|
73939884|NCT02363946|147412059|OTHER||alpha estimate|11.286|STANDARD_ERROR_OF_MEAN|0.058|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370||||
73973849|NCT04244175|147491203|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.171|TWO_SIDED|90.0|-0.7|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.1|-0.7|=0.171
73973850|NCT04244175|147491203|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.125|TWO_SIDED|90.0|-0.7|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||0.0|-0.7|=0.125
73973851|NCT04244175|147491204|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.0|||=|0.767|TWO_SIDED|90.0|-0.3|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||0.2|-0.3|=0.767
73973852|NCT04244175|147491204|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.2|||=|0.178|TWO_SIDED|90.0|0.0|0.5|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.5|0.0|=0.178
74031017|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.0||||0.373|TWO_SIDED|95.0|-134.8|50.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||50.8|-134.8|0.3730
74031018|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.3764|TWO_SIDED|95.0|-129.0|49.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||49.0|-129.0|0.3764
73939885|NCT02363946|147412059|OTHER||beta estimate|1.179|STANDARD_ERROR_OF_MEAN|0.041|||TWO_SIDED|95.0|1.11|1.249|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370|R-square (r\^2)=0.96|1.249|1.110|
74031019|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9807|TWO_SIDED|95.0|-1.2|1.17||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.17|-1.20|0.9807
73939886|NCT02363946|147412059|OTHER||alpha estimate|12.347|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP||||
73973853|NCT04244175|147491204|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.1|||=|0.542|TWO_SIDED|90.0|-0.1|0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||0.3|-0.1|=0.542
73973854|NCT04244175|147491204|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.106|TWO_SIDED|90.0|-0.6|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||0.0|-0.6|=0.106
73939887|NCT02363946|147412059|OTHER||beta estimate|1.163|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED|95.0|1.081|1.245|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP|R-square (r\^2)=0.95|1.245|1.081|
73867075|NCT03738618|147279221|OTHER||Treatment difference|26.8|||<|0.001|TWO_SIDED|95.0|19.8|30.8|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate in the fresh cycle||30.8|19.8|<0.001
73867076|NCT03738618|147279221|OTHER||Treatment difference|52.0|||<|0.001|TWO_SIDED|95.0|44.9|56.3|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate cumulatively||56.3|44.9|<0.001
73867077|NCT03738618|147279222|OTHER||Treatment difference|23.5|||<|0.001|TWO_SIDED|95.0|16.7|27.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate in the fresh cycle||27.2|16.7|<0.001
73939888|NCT01967732|147412068|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|77.43|||||TWO_SIDED|95.0|62.69|95.63|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||95.63|62.69|
73973855|NCT04244175|147491204|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.1|||=|0.663|TWO_SIDED|90.0|-0.2|0.4|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.4|-0.2|=0.663
73973856|NCT04244175|147491204|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.488|TWO_SIDED|90.0|-0.4|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||0.2|-0.4|=0.488
73973857|NCT04244175|147491204|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.1|TWO_SIDED|90.0|-0.7|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||0.0|-0.7|=0.100
73939889|NCT01967732|147412069|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|74.47|||||TWO_SIDED|95.0|61.52|90.14|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||90.14|61.52|
73939890|NCT01292239|147412093|SUPERIORITY_OR_OTHER||(see comment)|27.5|||<|0.0001|TWO_SIDED|95.0|14.38|40.56||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.|||40.56|14.38|<0.0001
73939891|NCT01292239|147412094|SUPERIORITY_OR_OTHER||(see comment)|32.6|||<|0.0001|TWO_SIDED|95.0|19.75|45.4||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.|||45.40|19.75|<0.0001
73939892|NCT01988779|147412108|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.505|||||||ANOVA|||||||0.505
73939893|NCT01988779|147412110|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.39|||||||ANOVA|||||||0.390
74088979|NCT02985879|147731174|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|3.88|=|0.243|TWO_SIDED|95.0|-3.11|12.19|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||12.19|-3.11|=0.243
73939894|NCT01988779|147412111|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.036|||||||ANOVA|||||||0.036
74008402|NCT03627767|147566508|SUPERIORITY||LSM difference|-0.7|||||TWO_SIDED|95.0|-0.9|-0.4||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-0.9|
73867078|NCT03738618|147279222|OTHER||Treatment difference|45.6|||<|0.001|TWO_SIDED|95.0|38.5|49.9|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate cumulatively||49.9|38.5|<0.001
73867079|NCT03738618|147279224|OTHER||Treatment difference|32.1|||<|0.001|TWO_SIDED|95.0|24.9|36.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate in the fresh cycle||36.2|24.9|<0.001
73939895|NCT00584727|147412113|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere by having more eyes see 20/20||||<0.0001
73939896|NCT00584727|147412114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7155|STANDARD_ERROR_OF_MEAN|0.1334||||95.0|0.3625|0.7155|||Mixed Models Analysis||Mean difference was senofilcon A toric minus etafilcon A sphere.|Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.||0.7155|0.3625|
73939897|NCT00584727|147412115|SUPERIORITY_OR_OTHER|||||||0.2161||95.0|||||Chi-squared|||Aletrnative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees.||||0.2161
73939898|NCT00584727|147412116|SUPERIORITY_OR_OTHER|||||||0.1328||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees||||0.1328
73939899|NCT00584727|147412117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.489|STANDARD_ERROR_OF_MEAN|0.1393||||95.0|0.1529|0.489|||Mixed Models Analysis||Mean difference was senofilcon A toric minus alphafilcon A toric|Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric.||0.4890|0.1529|
74031020|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8615|TWO_SIDED|95.0|-1.23|1.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.03|-1.23|0.8615
74031021|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0364|TWO_SIDED|95.0|0.04|1.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||1.14|0.04|0.0364
74031022|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.034|TWO_SIDED|95.0|0.04|1.08||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||1.08|0.04|0.0340
74088980|NCT02985879|147731175|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-26.4|STANDARD_ERROR_OF_MEAN|53.86||0.625|TWO_SIDED|95.0|-132.76|79.94|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||79.94|-132.76|0.625
74088981|NCT02985879|147731175|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|33.2|STANDARD_ERROR_OF_MEAN|55.47|=|0.55|TWO_SIDED|95.0|-76.34|142.71|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||142.71|-76.34|=0.550
74088982|NCT02985879|147731176|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1739.1|STANDARD_ERROR_OF_MEAN|2502.95|=|0.488|TWO_SIDED|95.0|-3201.75|6680.02|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||6680.02|-3201.75|=0.488
74088983|NCT02985879|147731176|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|3684.9|STANDARD_ERROR_OF_MEAN|2487.32|=|0.14|TWO_SIDED|95.0|-1225.46|8595.29|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||8595.29|-1225.46|=0.140
74088984|NCT02985879|147731177|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|207.9|STANDARD_ERROR_OF_MEAN|592.68|=|0.726|TWO_SIDED|95.0|-962.98|1378.88|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||1378.88|-962.98|=0.726
73867080|NCT03738618|147279224|OTHER||Treatment difference|58.9|||<|0.001|TWO_SIDED|95.0|51.9|63.0|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate cumulatively||63.0|51.9|<0.001
73867081|NCT03738618|147279236|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
73867082|NCT03738618|147279237|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
73867083|NCT03738618|147279238|OTHER|||||||0.19|||||||Fisher Exact|||||||0.190
73867084|NCT03738618|147279239|OTHER|||||||0.396|||||||Fisher Exact|||||||0.396
73867085|NCT01769196|147279285|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted, sLOXL2 level categories and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.13||||0.329|TWO_SIDED|95.0|0.88|1.45|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.|||1.45|0.88|0.329
73867086|NCT01769196|147279286|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 50th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.03||||0.851|TWO_SIDED|95.0|0.74|1.43|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||1.43|0.74|0.851
73939900|NCT00584727|147412118|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.||||<0.0001
74031023|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.6587|TWO_SIDED|95.0|-0.68|1.07||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.07|-0.68|0.6587
73867087|NCT01769196|147279287|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 75th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.2||||0.475|TWO_SIDED|95.0|0.72|2.0|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.00|0.72|0.475
73867088|NCT01769196|147279288|OTHER||Hazard Ratio (HR)|1.2||||0.602|TWO_SIDED|95.0|0.61|2.37|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.|||2.37|0.61|0.602
73867089|NCT01769196|147279289|OTHER|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.99||||0.988|TWO_SIDED|95.0|0.43|2.28|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.28|0.43|0.988
73939901|NCT00377403|147412121|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||The a priori threshold for statistical significnace was p less than or equal to 0.05|ANOVA|Adjusted for disease severity at baseline||We used analysis of variance, controlling for disease severity at baseline to test the null hypothesis that there was no difference between study groups at this point in time.||||0.83
73939902|NCT01181050|147412131|SUPERIORITY_OR_OTHER||Treatment difference|-0.02||||0.9334||95.0|-0.54|0.5|||Mixed effect model repeated measures|||||0.50|-0.54|0.9334
73939903|NCT01181050|147412132|SUPERIORITY_OR_OTHER||Treatment difference|0.06||||0.8293||95.0|-0.46|0.58|||Mixed effect model repeated measures|||||0.58|-0.46|0.8293
73973858|NCT04244175|147491204|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.0|||=|0.969|TWO_SIDED|90.0|-0.3|0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.3|-0.3|=0.969
73973859|NCT04244175|147491204|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.2|||=|0.344|TWO_SIDED|90.0|-0.4|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||0.1|-0.4|=0.344
73939904|NCT01181050|147412133|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.8867||95.0|-0.65|0.56|||Mixed effect model repeated measures|||||0.56|-0.65|0.8867
74031024|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.6554|TWO_SIDED|95.0|-0.63|1.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.00|-0.63|0.6554
74031025|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.1957|TWO_SIDED|95.0|-2.06|0.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.42|-2.06|0.1957
73867090|NCT01769196|147279290|OTHER|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.95||||0.925|TWO_SIDED|95.0|0.3|2.99|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.99|0.30|0.925
73867091|NCT00655629|147279310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.92|||<|0.0001||95.0|-8.45|-5.38|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.||-5.38|-8.45|<0.0001
73867092|NCT00655629|147279311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.972|||<|0.0001||95.0|-32.688|-19.256|||ANCOVA|||Statistical analysis applies to the total population.||-19.256|-32.688|<0.0001
73939905|NCT01018394|147412134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.108|TWO_SIDED|95.0|0.7|5.1||A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.|Fisher Exact|1 tailed||The percentage of participants who reduced tobacco use by greater or equal to 50% from baseline was compared between groups using Fisher's exact test. A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.||5.1|0.7|0.108
73939906|NCT00683644|147412136|OTHER|The observed power in THQ for zinc is 0.16, and that for placebo is 0.06.|||||>|0.05||||||Threshold for significance is 0.05|Chi-squared|||||||>0.05
73939907|NCT00683644|147412137|OTHER|||||||0.89||||||Threshold for significance is 0.05|paired t test|||||||0.89
73939908|NCT00683644|147412137|OTHER|||||||0.36||||||Threshold for significance is 0.05|paired t test|||||||0.36
74031026|NCT00570739|147615645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.1622|TWO_SIDED|95.0|-2.03|0.34||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.34|-2.03|0.1622
74031027|NCT00570739|147615646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|||<|0.0001|TWO_SIDED|95.0|3.51|8.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||8.48|3.51|<0.0001
73939909|NCT00683644|147412138|OTHER|||||||0.64||||||Threshold for significance is 0.05|paired t test|||||||0.64
73867093|NCT00655629|147279312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.432|||<|0.0001||95.0|-40.439|-26.425|||ANCOVA|||Statistical analysis applies to the total population.||-26.425|-40.439|<0.0001
73867094|NCT00655629|147279313|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|53.8693|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.||||<0.0001
73867095|NCT00655629|147279314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.078|||<|0.0001||95.0|-22.41|-9.746|||ANCOVA|||Statistical analysis applies to the total population.||-9.746|-22.41|<0.0001
73867096|NCT00655629|147279315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.134|||<|0.0001||95.0|-40.281|-25.987|||ANCOVA|||Statistical analysis applies to the total population.||-25.987|-40.281|<0.0001
73939910|NCT00683644|147412138|OTHER|||||||0.93||||||Threshold for significance is 0.05|paired t test|||||||0.93
74031028|NCT00570739|147615646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.31|||<|0.0001|TWO_SIDED|95.0|3.0|7.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||7.63|3.00|<0.0001
74031029|NCT00570739|147615646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.1742|TWO_SIDED|95.0|-0.3|0.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles||0.05|-0.30|0.1742
73867097|NCT00655629|147279316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.934|||<|0.0001||95.0|-41.119|-26.749|||ANCOVA|||Statistical analysis applies to the total population.||-26.749|-41.119|<0.0001
73867098|NCT00655629|147279317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.902|||<|0.0001||95.0|-27.724|-14.081|||ANCOVA|||Statistical analysis applies to the total population.||-14.081|-27.724|<0.0001
73867099|NCT00655629|147279319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.866|||<|0.0001||95.0|-22.599|-11.133|||ANCOVA|||Statistical analysis applies to the total population.||-11.133|-22.599|<0.0001
73867100|NCT00655629|147279320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.04|||<|0.0001||95.0|-31.547|-20.533|||ANCOVA|||Statistical analysis applies to the total population.||-20.533|-31.547|<0.0001
73867101|NCT00655629|147279321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.496|||<|0.0001||95.0|-24.676|-14.315|||ANCOVA|||Statistical analysis applies to the total population.||-14.315|-24.676|<0.0001
73867102|NCT00655629|147279322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.418|||<|0.0001||95.0|-24.439|-12.396|||ANCOVA|||Statistical analysis applies to the total population.||-12.396|-24.439|<0.0001
73867103|NCT00655629|147279323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.379|||<|0.0001||95.0|-28.006|-16.753|||ANCOVA|||Statistical analysis applies to the total population.||-16.753|-28.006|<0.0001
73867104|NCT00655629|147279324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.758|||<|0.0001||95.0|-36.736|-24.779|||ANOVA|||Statistical analysis applies to the total population.||-24.779|-36.736|<0.0001
73939911|NCT01669122|147412142|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
73939912|NCT01669122|147412142|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
73939913|NCT01669122|147412142|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.94|||||TWO_SIDED|90.0|0.91|0.97||||||Null hypothesis considered no difference in the treatments being compared.||0.97|0.91|
73939914|NCT01669122|147412143|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.02||||||Null hypothesis considered no difference in the treatments being compared.||1.02|0.93|
73939915|NCT01669122|147412143|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.99|||||TWO_SIDED|90.0|0.94|1.03||||||Null hypothesis considered no difference in the treatments being compared.||1.03|0.94|
73939916|NCT01669122|147412143|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.92|||||TWO_SIDED|90.0|0.88|0.96||||||Null hypothesis considered no difference in the treatments being compared.||0.96|0.88|
73939917|NCT01669122|147412144|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
73939918|NCT01669122|147412144|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
73939919|NCT01669122|147412144|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.93|||||TWO_SIDED|90.0|0.9|0.96||||||Null hypothesis considered no difference in the treatments being compared.||0.96|0.90|
73939920|NCT01669122|147412145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2208|TWO_SIDED|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.50|0.00|0.2208
74031030|NCT00570739|147615646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.187|TWO_SIDED|95.0|-0.28|0.06|||ANCOVA|||Low Density Lipoprotein Particles||0.06|-0.28|0.1870
74031031|NCT00570739|147615646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0063|TWO_SIDED|95.0|0.03|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.16|0.03|0.0063
73939921|NCT01669122|147412145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5695|TWO_SIDED|95.0|-0.25|0.25|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.25|-0.25|0.5695
73939922|NCT01669122|147412145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0063|TWO_SIDED|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.50|0.00|0.0063
73939923|NCT05520138|147412197|SUPERIORITY|With a 2-sided Type I of 0.05 significance.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|1.04|1.16|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.16|1.04|
73939924|NCT05520138|147412198|SUPERIORITY|With a 2-sided Type I of 0.05 significance.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|1.06|1.27|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.27|1.06|
73867105|NCT00655629|147279325|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|60.2391|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.||||<0.0001
73867106|NCT00183625|147279361|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|95.0|||||Regression, Linear|||||||0.66
73867107|NCT00183625|147279362|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||The p-value listed is for the medication by time interaction.|Mixed Models Analysis|||Mixed effects regression of body mass index on medication group (risp or olanz), time (in days over first 18 months of study) and a group by time interaction with site and baseline timepoint indicators as covariates. The model included a random slope and intercept for time.||||.0176
73939925|NCT05520138|147412199|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.99|1.1|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.10|0.99|
73939926|NCT05520138|147412200|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|1.06|1.22|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.22|1.06|
73939927|NCT00785291|147412208|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2||||0.054|TWO_SIDED|95.0|1.0|1.45||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.||1.45|1.00|0.054
73939928|NCT00785291|147412208|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.55|||<|0.0001|TWO_SIDED|95.0|1.28|1.87||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.||1.87|1.28|<0.0001
73973860|NCT04244175|147491205|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.01|TWO_SIDED|90.0|-0.7|-0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||-0.2|-0.7|=0.010
73973861|NCT04244175|147491205|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.376|TWO_SIDED|90.0|-0.4|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.1|-0.4|=0.376
73939929|NCT00785291|147412212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.2|TWO_SIDED|95.0|0.92|1.47||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank|||||1.47|0.92|0.20
73939930|NCT00785291|147412212|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.28||||0.038|TWO_SIDED|95.0|1.01|1.61||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank|||||1.61|1.01|0.038
73973862|NCT04244175|147491205|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.044|TWO_SIDED|90.0|-0.5|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||-0.1|-0.5|=0.044
73939931|NCT01466985|147412243|SUPERIORITY|Doravirine was declared superior to placebo when the upper bound of the 90% CI was \<-1.|Least squares (LS) mean difference|-1.37|||<|0.001||90.0|-1.6|-1.02|||ANCOVA|||||-1.02|-1.60|<0.001
73867108|NCT02678923|147279373|SUPERIORITY||LS mean difference|0.73||||0.0738|TWO_SIDED|95.0|-0.07|1.52||Baseline parameter value as a covariate and treatment group as factor, adjusting for country and prior statin use.|ANCOVA|||||1.52|-0.07|0.0738
73867109|NCT00098306|147279384|SUPERIORITY_OR_OTHER||LS mean difference|-0.788|STANDARD_ERROR_OF_MEAN|0.1571|||TWO_SIDED|97.5|-1.141|-0.435||||||The difference between the treatment least square means (LS means) adjusted for the randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.435|-1.141|
73867110|NCT00098306|147279384|SUPERIORITY_OR_OTHER||LS mean difference|-0.922|STANDARD_ERROR_OF_MEAN|0.1568|||TWO_SIDED|97.5|-1.275|-0.57||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.570|-1.275|
73867111|NCT00098306|147279385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88|||<|0.0001|TWO_SIDED|95.0|1.78|4.67|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \[\<\] 100,000 or greater than or equal to \[\>=\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\>) 1 favors maraviroc.||4.67|1.78|<0.0001
73867112|NCT00098306|147279385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.66|||<|0.0001|TWO_SIDED|95.0|2.26|5.95|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.95|2.26|<0.0001
73867113|NCT00098306|147279385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.96|||<|0.0001|TWO_SIDED|95.0|2.36|6.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.64|2.36|<0.0001
73867114|NCT00098306|147279385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.11|||<|0.0001|TWO_SIDED|95.0|3.04|8.59|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.59|3.04|<0.0001
73867115|NCT00098306|147279386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.63|4.13|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.13|1.63|<0.0001
73867116|NCT00098306|147279386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|1.79|4.54|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.54|1.79|<0.0001
73867117|NCT00098306|147279386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93|||<|0.0001|TWO_SIDED|95.0|1.83|4.67|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.67|1.83|<0.0001
73939932|NCT01466985|147412243|SUPERIORITY|Doravirine was declared superior to placebo when the upper bound of the 90% CI was \<-1.|LS mean difference|-1.26|||<|0.001|TWO_SIDED|90.0|-1.51|-1.02|||ANCOVA|||||-1.02|-1.51|<0.001
73939933|NCT03232983|147412305|SUPERIORITY||Ratio of Geometric Least Squares Means|1.03|||||TWO_SIDED|90.0|0.992|1.07|||Mixed Models Analysis|||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.07|0.992|
73939934|NCT03232983|147412305|SUPERIORITY||Ratio of Geometric Least Squares Means|1.0|||||TWO_SIDED|90.0|0.962|1.04|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.04|0.962|
73973863|NCT04244175|147491205|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.6|||=|0.005|TWO_SIDED|90.0|-1.0|-0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||-0.3|-1.0|=0.005
73973864|NCT04244175|147491205|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.549|TWO_SIDED|90.0|-0.5|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.2|-0.5|=0.549
73867118|NCT00098306|147279386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.08|5.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.32|2.08|<0.0001
73867119|NCT00098306|147279387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.92|4.88|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.88|1.92|<0.0001
73867120|NCT00098306|147279387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55|||<|0.0001|TWO_SIDED|95.0|2.22|5.68|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.68|2.22|<0.0001
73939935|NCT03232983|147412306|SUPERIORITY||Ratio of Geometric LSMeans|1.09|||||TWO_SIDED|90.0|1.0|1.2|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.20|1.00|
73939936|NCT03232983|147412306|SUPERIORITY||Ratio of Geometric LSMeans|1.14|||||TWO_SIDED|90.0|1.04|1.25|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.25|1.04|
73939937|NCT01627327|147412307|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.022||||0.201|TWO_SIDED|95.0|-0.012|0.055|||ANCOVA|||||0.055|-0.012|0.201
73939938|NCT02161133|147412331|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.62||0.712|TWO_SIDED||||||Mixed Models Analysis|||||||0.712
73939939|NCT02161133|147412332|SUPERIORITY||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|2.48||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
73867121|NCT00098306|147279387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.0001|TWO_SIDED|95.0|2.05|5.31|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.31|2.05|<0.0001
73867122|NCT00098306|147279387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||<|0.0001|TWO_SIDED|95.0|2.5|6.51|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.51|2.50|<0.0001
73867123|NCT00098306|147279388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.0006|TWO_SIDED|95.0|1.46|4.04|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.04|1.46|0.0006
73867124|NCT00098306|147279388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|1.9|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.23|1.90|<0.0001
73867125|NCT00098306|147279388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.32|7.25|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.25|2.32|<0.0001
73867126|NCT00098306|147279388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97|||<|0.0001|TWO_SIDED|95.0|2.82|8.77|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.77|2.82|<0.0001
73939940|NCT02161133|147412333|SUPERIORITY||Mean Difference (Final Values)|12.23|STANDARD_ERROR_OF_MEAN|10.45||0.244|TWO_SIDED||||||Mixed Models Analysis|||||||0.244
73939941|NCT02161133|147412334|SUPERIORITY||Mean Difference (Final Values)|-3.71|STANDARD_ERROR_OF_MEAN|1.95||0.057|TWO_SIDED||||||Mixed Models Analysis|||||||0.057
73939942|NCT02161133|147412335|SUPERIORITY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.57||0.382|TWO_SIDED||||||Mixed Models Analysis|||||||0.382
73939943|NCT02161133|147412336|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.703|TWO_SIDED||||||Mixed Models Analysis|||||||0.703
73973865|NCT04244175|147491205|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.048|TWO_SIDED|90.0|-0.7|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||-0.1|-0.7|=0.048
73973866|NCT04244175|147491205|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.6|||=|0.005|TWO_SIDED|90.0|-1.0|-0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||-0.3|-1.0|=0.005
73973867|NCT04244175|147491205|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.549|TWO_SIDED|90.0|-0.5|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.2|-0.5|=0.549
73867127|NCT00098306|147279390|SUPERIORITY_OR_OTHER||LS mean difference|54.49|STANDARD_ERROR_OF_MEAN|12.435|||TWO_SIDED|95.0|30.07|78.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||78.92|30.07|
73867128|NCT00098306|147279390|SUPERIORITY_OR_OTHER||LS mean difference|58.94|STANDARD_ERROR_OF_MEAN|12.378|||TWO_SIDED|95.0|34.63|83.26||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||83.26|34.63|
73867129|NCT00098306|147279390|SUPERIORITY_OR_OTHER||LS mean difference|58.56|STANDARD_ERROR_OF_MEAN|12.677|||TWO_SIDED|95.0|33.66|83.46||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||83.46|33.66|
73939944|NCT02161133|147412337|SUPERIORITY||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|1.36||0.168|TWO_SIDED||||||Mixed Models Analysis|||||||0.168
73939945|NCT02161133|147412338|SUPERIORITY||Mean Difference (Final Values)|-7.28|STANDARD_ERROR_OF_MEAN|2.93||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
73939946|NCT04341116|147412346|SUPERIORITY||Median Difference (Final Values)|9.0|STANDARD_ERROR_OF_MEAN|8.5||0.28|TWO_SIDED|95.0|-6.5|27.0|||Fisher Exact|||||27|-6.5|.28
73939947|NCT04794803|147412356|SUPERIORITY||||||=|0.02164|||||||Log Rank|||||||= 0.02164
73939948|NCT04794803|147412356|SUPERIORITY||||||=|0.20043|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: Supplemental oxygen requirement based on PaO2/FiO2||||= 0.20043
73867130|NCT00098306|147279390|SUPERIORITY_OR_OTHER||LS mean difference|68.47|STANDARD_ERROR_OF_MEAN|12.617|||TWO_SIDED|95.0|43.69|93.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||93.25|43.69|
73867131|NCT00098306|147279391|SUPERIORITY_OR_OTHER||LS mean difference|284.21|STANDARD_ERROR_OF_MEAN|51.779|||TWO_SIDED|95.0|182.51|385.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||385.92|182.51|
73939949|NCT04794803|147412356|SUPERIORITY||||||=|0.30215|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first invasive mechanical ventilation||||= 0.30215
73939950|NCT04794803|147412356|SUPERIORITY|||||||0.5637|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first admission to ICU||||0.56370
73939951|NCT04794803|147412356|SUPERIORITY||||||=|0.00132|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first use of a rescue medication for any reason||||= 0.00132
73939952|NCT04794803|147412357|SUPERIORITY|||||||0.731|||||||Fisher Exact|||comparison at week 1||||0.731
73939953|NCT04794803|147412357|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOT||||1.000
73939954|NCT04794803|147412357|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOS||||1.000
73973868|NCT04244175|147491205|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.048|TWO_SIDED|90.0|-0.7|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||-0.1|-0.7|=0.048
73973869|NCT04244175|147491206|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.49|||=|0.829|TWO_SIDED|90.0|-4.23|3.26|||ANCOVA||CVL-865 25 mg BID - Placebo|CVL-865 25 mg BID vs Placebo||3.26|-4.23|=0.829
74088985|NCT02985879|147731177|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|133.6|STANDARD_ERROR_OF_MEAN|611.91|=|0.828|TWO_SIDED|95.0|-1075.26|1342.4|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||1342.40|-1075.26|=0.828
73939955|NCT04794803|147412358|SUPERIORITY|||||||0.353|||||||Fisher Exact|||at baseline||||0.353
73939956|NCT04794803|147412358|SUPERIORITY|||||||0.401|||||||Fisher Exact|||At Day 1||||0.401
73939957|NCT04794803|147412358|SUPERIORITY|||||||0.066|||||||Fisher Exact|||At Day 2||||0.066
73973870|NCT04244175|147491206|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.2|||=|0.927|TWO_SIDED|90.0|-3.87|3.46|||ANCOVA||CVL-865 7.5 mg BID - Placebo|CVL-865 7.5 mg BID vs Placebo||3.46|-3.87|=0.927
74088986|NCT04843566|147731205|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Infection||||0.04
74088987|NCT04843566|147731205|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Urinary retention||||0.30
74088988|NCT04843566|147731205|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Bleeding requiring intervention||||0.31
73867132|NCT00098306|147279391|SUPERIORITY_OR_OTHER||LS mean difference|303.07|STANDARD_ERROR_OF_MEAN|51.507|||TWO_SIDED|95.0|201.9|404.23||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||404.23|201.90|
73939958|NCT04794803|147412358|SUPERIORITY|||||||0.102|||||||Fisher Exact|||At week 1||||0.102
73939959|NCT04794803|147412358|SUPERIORITY|||||||0.314|||||||Fisher Exact|||at EOT||||0.314
73939960|NCT04794803|147412358|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOS||||1.000
73939961|NCT04794803|147412359|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||>0.999
73939962|NCT04794803|147412359|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||>0.999
73939963|NCT04794803|147412359|SUPERIORITY|||||||0.05||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.050
73939964|NCT04794803|147412359|SUPERIORITY|||||||0.0227||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.0227
73939965|NCT04794803|147412360|SUPERIORITY|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||At Day 1||||0.122
73939966|NCT04794803|147412360|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||At Day 2||||0.985
73939967|NCT04794803|147412360|SUPERIORITY|||||||0.857|||||||Wilcoxon (Mann-Whitney)|||at week 1||||0.857
73939968|NCT04794803|147412360|SUPERIORITY|||||||0.436|||||||Wilcoxon (Mann-Whitney)|||at EOT||||0.436
73939969|NCT04794803|147412360|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||At EOS||||0.350
73939970|NCT04794803|147412361|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.596|||||||Fisher Exact|||Day 1||||0.596
73939971|NCT04794803|147412361|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.667|||||||Fisher Exact|||Day 2||||0.667
73939972|NCT04794803|147412361|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.037|||||||Fisher Exact|||Week 1||||0.037
73939973|NCT04794803|147412361|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.293||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOT||||0.293
73939974|NCT04794803|147412362|SUPERIORITY|||||||0.539||||||p-values are referred to a two-sided Fisher's Exact test for worsening and|Fisher Exact|||Day 1||||0.539
73939975|NCT04794803|147412362|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||Day 2||||1.000
73939976|NCT04794803|147412362|SUPERIORITY|||||||0.102||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||Week 1||||0.102
73939977|NCT04794803|147412362|SUPERIORITY|||||||0.119||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOT||||0.119
73939978|NCT04794803|147412362|SUPERIORITY|||||||0.515||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOS||||0.515
73939979|NCT04794803|147412363|SUPERIORITY|||||||0.366||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||Week 1||||0.366
73939980|NCT04794803|147412363|SUPERIORITY|||||||0.489||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||EOT||||0.489
73973871|NCT04244175|147491206|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.35|||=|0.859|TWO_SIDED|90.0|-3.57|2.88|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo|CVL-865 7.5 mg BID / 25 mg BID vs Placebo||2.88|-3.57|=0.859
74088989|NCT04843566|147731206|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Immediately following biopsy - Pain||||0.002
73939981|NCT04794803|147412363|SUPERIORITY|||||||0.486||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||EOS||||0.486
73939982|NCT04794803|147412364|SUPERIORITY|||||||0.79||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||Week 1||||0.790
73939983|NCT04794803|147412364|SUPERIORITY|||||||0.961||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||EOT||||0.961
73973872|NCT04244175|147491207|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|-0.013|||=|0.788|TWO_SIDED|90.0|-0.096|0.069|||ANCOVA||CVL-865 25 mg BID - Placebo (HUI-2)|CVL-865 25 mg BID vs Placebo (HUI-2)||0.069|-0.096|=0.788
73867133|NCT00098306|147279391|SUPERIORITY_OR_OTHER||LS mean difference|213.34|STANDARD_ERROR_OF_MEAN|49.679|||TWO_SIDED|95.0|115.77|310.92||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||310.92|115.77|
73939984|NCT04794803|147412364|SUPERIORITY|||||||0.619||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||EOS||||0.619
73939985|NCT04794803|147412365|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Baseline||||1.000
73939986|NCT04794803|147412365|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Day 1||||1.000
73939987|NCT04794803|147412365|SUPERIORITY|||||||0.678||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Day 2||||0.678
74088990|NCT04843566|147731206|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Immediately following biopsy - Discomfort||||0.05
74088991|NCT04843566|147731206|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||7-day post biopsy - Pain||||<0.0001
73939988|NCT04794803|147412365|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Week 1||||1.000
73939989|NCT04794803|147412365|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOT||||1.000
73939990|NCT04794803|147412365|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOS||||1.000
73939991|NCT04794803|147412366|SUPERIORITY|||||||0.696||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||Week 1||||0.696
73939992|NCT04794803|147412366|SUPERIORITY||||||>|0.999||||||p-values are referred to a-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||EOT||||>0.999
73939993|NCT04794803|147412366|SUPERIORITY|||||||0.596||||||p-values are referred to a-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||EOS||||0.596
73939994|NCT04794803|147412367|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Baseline||||1.000
73939995|NCT04794803|147412367|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||Day 1||||1.000
73939996|NCT04794803|147412367|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||Day 2||||1.000
73939997|NCT04794803|147412367|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||week 1||||1.000
73939998|NCT04794803|147412367|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOT||||1.000
73939999|NCT04794803|147412369|SUPERIORITY|||||||0.76||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||baseline||||0.760
73940000|NCT04794803|147412369|SUPERIORITY|||||||0.394||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||Week 1||||0.394
73940001|NCT04794803|147412369|SUPERIORITY|||||||0.141||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||EOT||||0.141
73940002|NCT04794803|147412369|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||EOS||||>0.999
73940003|NCT04794803|147412370|SUPERIORITY|||||||0.5||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||baseline||||0.500
73940004|NCT04794803|147412370|SUPERIORITY|||||||0.112||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||week 1||||0.112
73940005|NCT04794803|147412370|SUPERIORITY|||||||0.277||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||EOT||||0.277
74088992|NCT04843566|147731206|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||7-day post biopsy - Discomfort||||0.07
74088993|NCT04843566|147731207|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
73940006|NCT04794803|147412370|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||EOS||||>0.999
73867134|NCT00098306|147279391|SUPERIORITY_OR_OTHER||LS mean difference|235.74|STANDARD_ERROR_OF_MEAN|49.416|||TWO_SIDED|95.0|138.68|332.8||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||332.80|138.68|
73867135|NCT00098306|147279392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.34|0.6|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.60|0.34|<0.0001
73940007|NCT04794803|147412371|SUPERIORITY|||||||0.2027||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.2027
73940008|NCT04794803|147412371|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||1.0000
73940009|NCT04794803|147412371|SUPERIORITY|||||||0.4469||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Week 1 vs baseline||||0.4469
73940010|NCT04794803|147412371|SUPERIORITY|||||||0.2466||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.2466
73940011|NCT04794803|147412371|SUPERIORITY|||||||0.1752||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.1752
73973873|NCT04244175|147491207|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.077|||=|0.126|TWO_SIDED|90.0|-0.006|0.16|||ANCOVA||CVL-865 7.5 mg BID - Placebo (HUI-2)|CVL-865 7.5 mg BID vs Placebo (HUI-2)||0.160|-0.006|=0.126
73973874|NCT04244175|147491207|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.032|||=|0.461|TWO_SIDED|90.0|-0.039|0.103|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo (HUI-2)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (HUI-2)||0.103|-0.039|=0.461
73973875|NCT04244175|147491207|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|-0.032|||=|0.661|TWO_SIDED|90.0|-0.154|0.089|||ANCOVA||CVL-865 25 mg BID - Placebo (HUI-3)|CVL-865 25 mg BID vs Placebo (HUI-3)||0.089|-0.154|=0.661
73973876|NCT04244175|147491207|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.115|||=|0.124|TWO_SIDED|90.0|-0.008|0.237|||ANCOVA||CVL-865 7.5 mg BID - Placebo (HUI-3)|CVL-865 7.5 mg BID vs Placebo (HUI-3)||0.237|-0.008|=0.124
73973877|NCT04244175|147491207|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.041|||=|0.518|TWO_SIDED|90.0|-0.064|0.146|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo (HUI-3)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (HUI-3)||0.146|-0.064|=0.518
73973878|NCT03781089|147491236|OTHER|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
73973879|NCT03781089|147491237|OTHER|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
73973880|NCT02163694|147491248|SUPERIORITY|||||||0.003|||||||Log-rank test|||PFS was compared between the treatment groups using the log-rank test, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\] positive versus ER/PgR negative).||||0.003
73973881|NCT02163694|147491248|SUPERIORITY||Stratified Cox proportional hazards|0.728||||0.003|TWO_SIDED|95.0|0.59|0.9|||Stratified Cox proportional hazards|||A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.||0.900|0.590|0.003
73973882|NCT02163694|147491249|SUPERIORITY|||||||0.41|||||||Log Rank|||||||0.410
73973883|NCT02163694|147491249|SUPERIORITY||Stratified Cox proportional hazards|0.914||||0.41|TWO_SIDED|95.0|0.737|1.333|||Stratified Cox proportional hazards|||A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.||1.333|0.737|0.410
73973884|NCT02163694|147491250|SUPERIORITY|||||||0.202||||||Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.|Cochran-Mantel-Haenszel|||||||0.202
74088994|NCT04843566|147731208|SUPERIORITY|||||||0.59|||||||Chi-squared|||Gleason grade \>=2||||0.59
73940012|NCT04794803|147412372|SUPERIORITY|||||||0.6441||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.6441
73940013|NCT04794803|147412372|SUPERIORITY|||||||0.3529||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.3529
73940014|NCT04794803|147412372|SUPERIORITY|||||||0.3581||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.3581
73940015|NCT04794803|147412372|SUPERIORITY|||||||0.1666||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.1666
73940016|NCT04794803|147412372|SUPERIORITY|||||||0.0851||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.0851
73940017|NCT04794803|147412373|SUPERIORITY|||||||0.3359||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.3359
73940018|NCT04794803|147412373|SUPERIORITY|||||||0.3136||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.3136
73940019|NCT04794803|147412373|SUPERIORITY|||||||0.0441||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.0441
73940020|NCT04794803|147412373|SUPERIORITY|||||||0.0965||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.0965
74088995|NCT04843566|147731209|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Infection||||0.04
74088996|NCT04843566|147731209|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Urinary retention||||0.30
73940021|NCT04794803|147412373|SUPERIORITY|||||||0.0519||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.0519
73940022|NCT04794803|147412374|SUPERIORITY|||||||0.47||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.470
73940023|NCT04794803|147412374|SUPERIORITY|||||||0.425||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.425
73940024|NCT04794803|147412374|SUPERIORITY|||||||0.086||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.086
73940025|NCT04794803|147412374|SUPERIORITY|||||||0.6||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.600
73940026|NCT04794803|147412374|SUPERIORITY|||||||0.717||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.717
73940027|NCT04124926|147412375|NON_INFERIORITY|The noninferiority of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in EE rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|8.3|||<|0.0001|TWO_SIDED|95.0|4.49|12.23||2-sided p-value.|Farrington and Manning test||The 2-sided 95% confidence interval (CI) of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||12.23|4.49|<0.0001
73940028|NCT04124926|147412376|NON_INFERIORITY|The noninferiority of each dose group of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in maintenance of healing rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|8.7|||<|0.0001|TWO_SIDED|95.0|1.8|15.53||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE maintenance rates between each vonoprazan group and lansoprazole group was calculated via the Miettinen and Nurminen method.|||15.53|1.80|<0.0001
73940029|NCT04124926|147412376|NON_INFERIORITY|The noninferiority of each dose group of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in maintenance of healing rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|7.2|||<|0.0001|TWO_SIDED|95.0|0.21|14.09||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE maintenance rates between each vonoprazan group and lansoprazole group was calculated via the Miettinen and Nurminen method.|||14.09|0.21|<0.0001
73940030|NCT04124926|147412376|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.||||||0.0136||||||2-sided p-value.|Farrington and Manning test|||||||0.0136
73940031|NCT04124926|147412376|SUPERIORITY|The superiority of the vonoprazan 10 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.||||||0.0436||||||2-sided p-value.|Farrington and Manning test|||||||0.0436
73940032|NCT04124926|147412377|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.7|||||TWO_SIDED|95.0|-1.6|7.03|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between vonoprazan 20 mg and lansoprazole 30 mg was calculated from Welch's t-test.|||7.03|-1.60|
73940033|NCT04124926|147412378|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|17.6||||0.0008|TWO_SIDED|95.0|7.44|27.43||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||27.43|7.44|0.0008
73973885|NCT02163694|147491251|SUPERIORITY|||||||0.715||||||Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.|Cochran-Mantel-Haenszel|||||||0.715
74088997|NCT04843566|147731209|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Bleeding requiring intervention||||0.31
73940034|NCT04124926|147412379|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|2.3||||0.4392|TWO_SIDED|95.0|-3.5|8.04||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in sustained resolution rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||8.04|-3.50|0.4392
73973886|NCT02163694|147491252|SUPERIORITY|||||||0.004|||||||Log Rank|||||||0.004
73973887|NCT02163694|147491252|SUPERIORITY||Stratified Cox proportional hazards|0.737||||0.004|TWO_SIDED|95.0|0.597|0.908|||Stratified Cox proportional hazards|Stratified by prior platinum therapy (yes vs no) and receptor status (ER and/or PgR positive vs ER/PgR negative).||||0.908|0.597|0.004
74088998|NCT02516410|147731301|SUPERIORITY||Least squares (LS) mean difference|1.2|||=|0.1176|TWO_SIDED|95.0|-0.3|2.6|||Mixed-effect repeated measure (MMRM)|||||2.6|-0.3|= 0.1176
74088999|NCT01252719|147731317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population was greater than -10%, the NI of oritavancin to vancomycin was concluded.|Difference in Proportions|-0.4|||||TWO_SIDED|95.0|-5.5|4.7||||||||4.7|-5.5|
73940035|NCT04124926|147412380|SUPERIORITY|Observed p-value and not a formal test per the preplanned fixed-sequence testing procedure. The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|19.6|||<|0.0001|TWO_SIDED|95.0|11.84|27.58||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||27.58|11.84|<0.0001
73940036|NCT04124926|147412381|SUPERIORITY|Observed p-value and not a formal test per the preplanned fixed-sequence testing procedure. The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|6.1||||0.0348|TWO_SIDED|95.0|0.53|11.6||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||11.60|0.53|0.0348
73940037|NCT04124926|147412382|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|15.7||||0.0196|TWO_SIDED|95.0|2.5|28.44||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in maintenance rates between each vonoprazan group and lansoprazole 15 mg group was calculated via the Miettinen and Nurminen method.|||28.44|2.50|0.0196
73940038|NCT04124926|147412382|SUPERIORITY|The superiority of the vonoprazan 10 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|13.3||||0.049|TWO_SIDED|95.0|0.02|26.14||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in maintenance rates between each vonoprazan group and lansoprazole 15 mg group was calculated via the Miettinen and Nurminen method.|||26.14|0.02|0.0490
73940039|NCT04124926|147412383|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.0|||||TWO_SIDED|95.0|-2.63|6.72|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between each vonoprazan group and the lansoprazole group was calculated from Welch's t-test.|||6.72|-2.63|
73973888|NCT02994927|147491292|NON_INFERIORITY|The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|3.4|||<|0.0001|TWO_SIDED|95.0|-6.0|12.8|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||12.8|-6.0|< 0.0001
73973889|NCT02994927|147491292|SUPERIORITY|The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|3.4|||=|0.2387|TWO_SIDED|95.0|-6.0|12.8|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||12.8|-6.0|= 0.2387
73973890|NCT02994927|147491293|NON_INFERIORITY|The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|12.5|||<|0.0001|TWO_SIDED|95.0|2.6|22.3|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||22.3|2.6|< 0.0001
73973891|NCT02994927|147491293|SUPERIORITY|The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|12.5|||=|0.0066|TWO_SIDED|95.0|2.6|22.3|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||22.3|2.6|= 0.0066
73973892|NCT03533257|147491322|SUPERIORITY|||||||0.3654|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3654
73867136|NCT00098306|147279392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.28|0.5|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.50|0.28|<0.0001
74031032|NCT00570739|147615646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.002|TWO_SIDED|95.0|0.04|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.16|0.04|0.0020
73940040|NCT04124926|147412383|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.3|||||TWO_SIDED|95.0|-2.27|6.84|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between each vonoprazan group and the lansoprazole group was calculated from Welch's t-test.|||6.84|-2.27|
73940041|NCT00423176|147412384|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44||||||95.0|-1.14|0.25|||||For days 1-29|||0.25|-1.14|
73940042|NCT00423176|147412384|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.82||||||95.0|-1.65|0.0|||||For follow-up days 30-43|||0.00|-1.65|
73940043|NCT00423176|147412385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.8||||||95.0|-0.5|18.2|||||Change from baseline to endpoint|||18.2|-0.5|
73940044|NCT03871595|147412386|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|99.51|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|95.36|103.83|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||103.83|95.36|
74031033|NCT00570739|147615647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4||||0.0022|TWO_SIDED|95.0|8.9|39.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides||39.9|8.9|0.0022
73940045|NCT03871595|147412387|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|70.11|STANDARD_DEVIATION|16.8|||TWO_SIDED|90.0|62.67|78.44|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||78.44|62.67|
73940046|NCT03871595|147412388|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|99.78|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|95.64|104.11|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||104.11|95.64|
73940047|NCT05554237|147412396|OTHER||Ratio of adjusted geometric means|83.46|||||TWO_SIDED|90.0|74.67|93.29|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only)|||93.29|74.67|
73940048|NCT05554237|147412398|OTHER||Ratio of adjusted geometric means|89.7|||||TWO_SIDED|90.0|87.24|92.23|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only|||92.23|87.24|
73940049|NCT05554237|147412401|OTHER||Ratio of adjusted geometric means|89.91|||||TWO_SIDED|90.0|87.47|92.41|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only|||92.41|87.47|
73940050|NCT05554237|147412421|OTHER||Ratio of adjusted geometric mean|104.47|||||TWO_SIDED|90.0|84.94|128.5|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||128.50|84.94|
73940051|NCT05554237|147412421|OTHER||Ratio of adjusted geometric mean|129.54|||||TWO_SIDED|90.0|119.37|140.58|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||140.58|119.37|
73940052|NCT05554237|147412421|OTHER||Ratio of adjusted geometric mean|101.46|||||TWO_SIDED|90.0|88.68|116.08|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||116.08|88.68|
73940053|NCT05554237|147412421|OTHER||Ratio of adjusted geometric means|86.99|||||TWO_SIDED|90.0|74.48|101.59|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only|Trans-CTB Day 6 versus Day 7||101.59|74.48|
73940054|NCT05554237|147412423|OTHER||Ratio of adjusted geometric mean|102.21|||||TWO_SIDED|90.0|88.67|117.8|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||117.80|88.67|
73940055|NCT05554237|147412423|OTHER||Ratio of adjusted geometric mean|133.79|||||TWO_SIDED|90.0|119.84|149.36|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||149.36|119.84|
73940056|NCT05554237|147412423|OTHER||Ratio of adjusted geometric mean|99.93|||||TWO_SIDED|90.0|90.7|110.1|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||110.10|90.70|
73940057|NCT05554237|147412423|OTHER||Ratio of adjusted geometric mean|89.17|||||TWO_SIDED|90.0|75.27|105.63|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only|Trans-CTB Day 6 versus Day 7||105.63|75.27|
73940058|NCT05554237|147412429|OTHER||Ratio of adjusted geometric mean|93.69|||||TWO_SIDED|90.0|78.37|112.02|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||112.02|78.37|
73940059|NCT05554237|147412429|OTHER||Ratio of adjusted geometric mean|113.07|||||TWO_SIDED|90.0|88.31|144.76|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI-CTB Day 6 versus Day 7||144.76|88.31|
73940060|NCT05554237|147412429|OTHER||Ratio of adjusted geometric mean|107.06||||||90.0|92.77|123.54|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||123.54|92.77|
73940061|NCT05554237|147412429|OTHER||Ratio of adjusted geometric mean|80.68|||||TWO_SIDED|90.0|68.32|95.27|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||95.27|68.32|
73940062|NCT05554237|147412429|OTHER||Ratio of adjusted geometric mean|89.92|||||TWO_SIDED|90.0|69.7|116.02|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||116.02|69.70|
73940063|NCT05554237|147412429|OTHER||Ratio of adjusted geometric mean|97.65|||||TWO_SIDED|90.0|84.08|113.41|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||113.41|84.08|
73940064|NCT05554237|147412430|OTHER||Ratio of adjusted geometric mean|102.33|||||TWO_SIDED|90.0|90.37|115.87|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||115.87|90.37|
73940065|NCT05554237|147412430|OTHER||Ratio of adjusted geometric mean|117.83|||||TWO_SIDED|90.0|100.61|138.0|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||138.00|100.61|
73940066|NCT05554237|147412430|OTHER||Ratio of adjusted geometric mean|115.88|||||TWO_SIDED|90.0|104.12|128.98|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||128.98|104.12|
73940067|NCT05554237|147412430|OTHER||Ratio of adjusted geometric mean|85.27|||||TWO_SIDED|90.0|70.37|103.32|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||103.32|70.37|
73940068|NCT05554237|147412430|OTHER||Ratio of adjusted geometric mean|97.69|||||TWO_SIDED|90.0|78.83|121.06|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||121.06|78.83|
73940069|NCT05554237|147412430|OTHER||Ratio of adjusted geometric mean|102.85|||||TWO_SIDED|90.0|94.8|111.58|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||111.58|94.80|
73940070|NCT05554237|147412445|OTHER||Ratio of adjusted geometric mean|105.47|||||TWO_SIDED|90.0|86.64|128.39|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||128.39|86.64|
73940071|NCT05554237|147412445|OTHER||Ratio of adjusted geometric mean|134.24||||||90.0|51.81|347.81|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||347.81|51.81|
73940072|NCT05554237|147412445|OTHER||Ratio of adjusted geometric mean|91.17||||||90.0|79.54|104.51|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||104.51|79.54|
73940073|NCT05554237|147412445|OTHER||Ratio of adjusted geometric mean|115.26|||||TWO_SIDED|90.0|71.46|185.9|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||185.90|71.46|
73940074|NCT05554237|147412447|OTHER||Ratio of adjusted geometric mean|114.83|||||TWO_SIDED|90.0|101.1|130.43|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||130.43|101.10|
73940075|NCT05554237|147412447|OTHER||Ratio of adjusted geometric mean|140.44|||||TWO_SIDED|90.0|104.17|189.34|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||189.34|104.17|
73940076|NCT05554237|147412447|OTHER||Ratio of adjusted geometric mean|101.46||||||90.0|90.79|113.39|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||113.39|90.79|
73973893|NCT03533257|147491323|SUPERIORITY|||||||0.6698|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.6698
73973894|NCT03533257|147491324|SUPERIORITY|||||||0.3086|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3086
73940077|NCT05554237|147412447|OTHER||Ratio of adjusted geometric means|123.2|||||TWO_SIDED|90.0|110.25|137.67|||||Model is a mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||137.67|110.25|
73940078|NCT04435366|147412453|SUPERIORITY||Least Squares Mean Difference|0.056|STANDARD_ERROR_OF_MEAN|0.02||0.0064|TWO_SIDED|95.0|0.016|0.096||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol). Mixed Model for repeated measures (MMRM) was used to compare the treatment groups.||0.096|0.016|0.0064
73940079|NCT04435366|147412454|SUPERIORITY||Least Squares Mean Difference|0.362|STANDARD_ERROR_OF_MEAN|0.15||0.0165|TWO_SIDED|95.0|0.066|0.657||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||0.657|0.066|0.0165
73940080|NCT04435366|147412454|SUPERIORITY||Least Squares Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.152||0.0015|TWO_SIDED|95.0|0.189|0.788||Nominal p-value was used for the comparison between avacincaptad pegol and sham versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol and sham).||0.788|0.189|0.0015
73973895|NCT03533257|147491325|SUPERIORITY|||||||0.5552|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.5552
73940081|NCT04435366|147412455|SUPERIORITY||Least Squares Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.5||0.58|TWO_SIDED|95.0|-3.79|2.12||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||2.12|-3.79|0.58
73940082|NCT04435366|147412456|SUPERIORITY||Least Squares Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|1.68||0.38|TWO_SIDED|95.0|-4.79|1.81||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||1.81|-4.79|0.38
73940083|NCT04435366|147412458|SUPERIORITY||Least square mean difference|-0.712|STANDARD_ERROR_OF_MEAN|1.33||0.5929|TWO_SIDED|95.0|-3.326|1.903|||MMRM|||||1.903|-3.326|0.5929
73940084|NCT04435366|147412460|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6424|TWO_SIDED|95.0|0.57|1.42|||Log Rank|||||1.42|0.57|0.6424
74031034|NCT00570739|147615647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.3||||0.0013|TWO_SIDED|95.0|9.6|39.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides||39.1|9.6|0.0013
73867137|NCT00098306|147279393|SUPERIORITY_OR_OTHER||LS mean difference|-0.697|STANDARD_ERROR_OF_MEAN|0.1347|||TWO_SIDED|95.0|-0.961|-0.432||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.432|-0.961|
73940085|NCT03492281|147412480|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.8|-0.2||Hypothesis testing was performed for vibegron minus placebo.|Mixed Model for Repeated Measures (MMRM)|||||-0.2|-0.8|<0.001
73940086|NCT03492281|147412480|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16|=|0.0988|TWO_SIDED|95.0|-0.6|0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||0.1|-0.6|=0.0988
73940087|NCT03492281|147412481|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.3||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.3|-0.9|<0.0001
73940088|NCT03492281|147412481|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15|=|0.0123|TWO_SIDED|95.0|-0.7|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.7|=0.0123
73940089|NCT03492281|147412482|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22|=|0.002|TWO_SIDED|95.0|-1.1|-0.2||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.2|-1.1|=0.0020
73940090|NCT03492281|147412482|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23|=|0.0648|TWO_SIDED|95.0|-0.9|0.0||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||0.0|-0.9|=0.0648
73940091|NCT03492281|147412483|SUPERIORITY||Difference in percentage|16.5|||<|0.0001|TWO_SIDED|95.0|9.7|23.4|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||23.4|9.7|<0.0001
73940092|NCT03492281|147412483|SUPERIORITY||Difference in percentage|9.4|||=|0.012|TWO_SIDED|95.0|2.1|16.7|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||16.7|2.1|=0.0120
73940093|NCT03492281|147412484|SUPERIORITY||Difference in percentage|6.3|||=|0.036|TWO_SIDED|95.0|0.4|12.1|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||12.1|0.4|=0.0360
73940094|NCT03492281|147412484|SUPERIORITY||Difference in percentage|1.9|||=|0.5447|TWO_SIDED|95.0|-4.1|7.8|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||7.8|-4.1|=0.5447
73940095|NCT03492281|147412485|SUPERIORITY||Difference in percentage|6.8|||=|0.0235|TWO_SIDED|95.0|0.9|12.7|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex and OAB type (wet/dry), with weights proposed by Greenland and Robins.||||12.7|0.9|=0.0235
73940096|NCT03492281|147412485|SUPERIORITY||Difference in percentage|3.7|||=|0.24|TWO_SIDED|95.0|-2.5|10.0|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex and OAB type (wet/dry), with weights proposed by Greenland and Robins.||||10.0|-2.5|=0.2400
73940097|NCT03492281|147412486|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.4|-1.0|<0.0001
73940098|NCT03492281|147412486|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17|=|0.0074|TWO_SIDED|95.0|-0.8|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.8|=0.0074
73940099|NCT03492281|147412487|SUPERIORITY||Least Squares Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|1.24|=|0.0039|TWO_SIDED|95.0|1.2|6.0||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||6.0|1.2|=0.0039
73940100|NCT03492281|147412487|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.32|=|0.021|TWO_SIDED|95.0|0.5|5.7||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||5.7|0.5|=0.0210
73940101|NCT03492281|147412488|SUPERIORITY||Least Squares Mean Difference|21.2|STANDARD_ERROR_OF_MEAN|3.52|<|0.0001|TWO_SIDED|95.0|14.3|28.1||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||28.1|14.3|<0.0001
73940102|NCT03492281|147412488|SUPERIORITY||Least Squares Mean Difference|13.3|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|5.9|20.7||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||20.7|5.9|<0.001
73940103|NCT03492281|147412489|SUPERIORITY||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|1.7|5.8||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||5.8|1.7|<0.001
73940104|NCT03492281|147412489|SUPERIORITY||Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|1.13|=|0.0114|TWO_SIDED|95.0|0.6|5.1|||MMRM|||||5.1|0.6|=0.0114
73940105|NCT03492281|147412490|SUPERIORITY||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-9.2|-4.6||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-4.6|-9.2|<0.0001
73940106|NCT03492281|147412490|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.25|<|0.001|TWO_SIDED|95.0|-7.1|-2.2||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-2.2|-7.1|<0.001
73867138|NCT00098306|147279393|SUPERIORITY_OR_OTHER||LS mean difference|-0.802|STANDARD_ERROR_OF_MEAN|0.1344|||TWO_SIDED|95.0|-1.065|-0.538||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.538|-1.065|
73867139|NCT00098306|147279393|SUPERIORITY_OR_OTHER||LS mean difference|-0.767|STANDARD_ERROR_OF_MEAN|0.1497|||TWO_SIDED|95.0|-1.061|-0.474||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.474|-1.061|
73867140|NCT00098306|147279393|SUPERIORITY_OR_OTHER||LS mean difference|-0.931|STANDARD_ERROR_OF_MEAN|0.1494|||TWO_SIDED|95.0|-1.225|-0.638||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.638|-1.225|
73973896|NCT03533257|147491326|SUPERIORITY|||||||0.0361|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.0361
73973897|NCT03533257|147491327|SUPERIORITY|||||||0.3585|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3585
73973898|NCT03533257|147491328|SUPERIORITY|||||||0.8996|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.8996
73867141|NCT00098306|147279394|SUPERIORITY_OR_OTHER||LS mean difference|-0.853|STANDARD_ERROR_OF_MEAN|0.1621|||TWO_SIDED|97.5|-1.217|-0.489||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.489|-1.217|
73940107|NCT03492281|147412491|SUPERIORITY||Difference in percentage|12.4|||<|0.0001|TWO_SIDED|95.0|6.7|18.1||CMH=Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel|The CMH risk difference estimate was stratified by OAB type (wet/dry) and sex (female/male), with weights proposed by Greenland and Robins.||||18.1|6.7|<0.0001
73940108|NCT03492281|147412491|SUPERIORITY||Difference in percentage|6.9|||=|0.0236|TWO_SIDED|95.0|0.9|12.8|||Cochran-Mantel-Haenszel|The CMH risk difference estimate was stratified by OAB type (wet/dry) and sex (female/male), with weights proposed by Greenland and Robins.||||12.8|0.9|=0.0236
73973899|NCT03493542|147491329|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.42|||<|0.0001|TWO_SIDED|95.0|1.28|1.58|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 6||1.58|1.28|<0.0001
73973900|NCT03493542|147491329|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.39|||<|0.0001|TWO_SIDED|95.0|1.25|1.55|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 11||1.55|1.25|<0.0001
74031035|NCT00570739|147615647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.3||||0.0006|TWO_SIDED|95.0|11.5|41.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides||41.0|11.5|0.0006
73867142|NCT00098306|147279394|SUPERIORITY_OR_OTHER||LS mean difference|-1.021|STANDARD_ERROR_OF_MEAN|0.1618|||TWO_SIDED|97.5|-1.385|-0.658||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.658|-1.385|
73867143|NCT04856904|147279460|SUPERIORITY||Bilateral difference|-3.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.4|-2.0|||Student's t-test for paired samples|||||-2|-4.4|< 0.0001
73940109|NCT03492281|147412492|SUPERIORITY||Difference in percentage|11.7|||<|0.001|TWO_SIDED|95.0|4.7|18.6|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||18.6|4.7|<0.001
73973901|NCT03493542|147491329|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.53|||<|0.0001|TWO_SIDED|95.0|1.37|1.7|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 16||1.70|1.37|<0.0001
73973902|NCT03493542|147491329|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.66|||<|0.0001|TWO_SIDED|95.0|1.45|1.9|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 18||1.90|1.45|<0.0001
73973903|NCT03493542|147491350|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 6||1.2|-1.1|<0.0001
73867144|NCT04856904|147279461|SUPERIORITY||Bilateral difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|=|0.9476|TWO_SIDED|95.0|-0.3|0.3|||Student's t-test for paired samples|||Week 1: Trifarotene 50 mcg/g, vehicle cream||0.3|-0.3|= 0.9476
73867145|NCT04856904|147279461|SUPERIORITY||Bilateral difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25|=|0.0248|TWO_SIDED|95.0|-1.1|-0.1|||Student's t-test for paired samples|||Week 2: Trifarotene 50 mcg/g, vehicle cream||-0.1|-1.1|= 0.0248
73867146|NCT04856904|147279461|SUPERIORITY||Bilateral difference|-0.8|STANDARD_ERROR_OF_MEAN|0.29|=|0.0072|TWO_SIDED|95.0|-1.4|-0.2|||Student's t-test for paired samples|||Week 4: Trifarotene 50 mcg/g, vehicle cream||-0.2|-1.4|= 0.0072
73940110|NCT03492281|147412492|SUPERIORITY||Difference in percentage|11.5|||=|0.0022|TWO_SIDED|95.0|4.2|18.9|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||18.9|4.2|=0.0022
73940111|NCT03492281|147412493|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.1|-0.3|<0.0001
74089000|NCT01252719|147731318|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% confidence interval (CI) for the difference in response rates in the mITT population was greater than -10% the non-inferiority (NI) of oritavancin to vancomycin was concluded.|Difference in Proportions|3.4|||||TWO_SIDED|95.0|-1.6|8.4||||||||8.4|-1.6|
74031036|NCT00570739|147615647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.5||||0.0003|TWO_SIDED|95.0|12.5|40.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides||40.6|12.5|0.0003
74031037|NCT00570739|147615647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1257|TWO_SIDED|95.0|-0.4|3.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol||3.5|-0.4|0.1257
74031038|NCT00570739|147615647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1054|TWO_SIDED|95.0|-0.3|3.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol||3.3|-0.3|0.1054
74031039|NCT00570739|147615648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2971|TWO_SIDED|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||0.03|-0.11|0.2971
74031040|NCT00570739|147615648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2567|TWO_SIDED|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||0.03|-0.11|0.2567
74031041|NCT00570739|147615648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.1081|TWO_SIDED|95.0|-0.13|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks||0.01|-0.13|0.1081
74031042|NCT00570739|147615648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.079|TWO_SIDED|95.0|-0.17|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.01|-0.17|0.0790
74031043|NCT00570739|147615648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.0206|TWO_SIDED|95.0|-0.18|-0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-0.01|-0.18|0.0206
74031044|NCT00570739|147615649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0009|TWO_SIDED|95.0|-6.8|-1.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||-1.8|-6.8|0.0009
74031045|NCT00570739|147615649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1184|TWO_SIDED|95.0|-4.5|0.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||0.5|-4.5|0.1184
74031046|NCT00570739|147615649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.0615|TWO_SIDED|95.0|-5.8|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks||0.1|-5.8|0.0615
74031047|NCT00570739|147615649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.3617|TWO_SIDED|95.0|-7.2|2.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||2.6|-7.2|0.3617
73867147|NCT04856904|147279461|SUPERIORITY||Bilateral difference|-1.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.1|-0.7|||Student's t-test for paired samples|||Week 8: Trifarotene 50 mcg/g, vehicle cream||-0.7|-2.1|< 0.0001
74031048|NCT00570739|147615649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2372|TWO_SIDED|95.0|-7.0|1.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.7|-7.0|0.2372
74031049|NCT00570739|147615650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.921||||0.2982|TWO_SIDED|95.0|-0.821|2.663||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||2.663|-0.821|0.2982
74031050|NCT00570739|147615650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.695||||0.2361|TWO_SIDED|95.0|-0.458|1.848||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||1.848|-0.458|0.2361
74031051|NCT00570739|147615650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.218||||0.0413|TWO_SIDED|95.0|-2.388|-0.049|||ANCOVA|||Baseline to 12 Weeks||-0.049|-2.388|0.0413
74031052|NCT00570739|147615650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.434||||0.7858|TWO_SIDED|95.0|-3.583|2.715|||ANCOVA|||Baseline to 16 Weeks||2.715|-3.583|0.7858
74031053|NCT00570739|147615650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.493||||0.7314|TWO_SIDED|95.0|-3.321|2.335|||ANCOVA|||Baseline to 16 Weeks LOCF||2.335|-3.321|0.7314
74031054|NCT00570739|147615651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.089||||0.553|TWO_SIDED|95.0|-0.385|0.207||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.207|-0.385|0.5530
74089001|NCT01252719|147731319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population was greater than -10% the NI of oritavancin to vancomycin was concluded.|Difference in Proportions|4.1|||||TWO_SIDED|95.0|-0.5|8.6||||||||8.6|-0.5|
73867148|NCT04856904|147279461|SUPERIORITY||Bilateral difference|-2.1|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-2.9|-1.3|||Student's t-test for paired samples|||Week 12: Trifarotene 50 mcg/g, vehicle cream||-1.3|-2.9|< 0.0001
73940112|NCT03492281|147412493|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05|=|0.0055|TWO_SIDED|95.0|-0.2|0.0||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||0.0|-0.2|=0.0055
73940113|NCT03492281|147412494|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.2|-0.4|<0.0001
73940114|NCT03492281|147412494|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.3|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.3|<0.001
73940115|NCT01506193|147412495|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for measles was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.04|||||TWO_SIDED|95.0|-1.82|2.78||||||"Immune response for anti-measles antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-measles seroconversion rates (SCRs) at Day 42 after dose 1."||2.78|-1.82|
73940116|NCT01506193|147412495|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for mumps was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|1.29|||||TWO_SIDED|95.0|-3.04|6.67||||||"Immune response for anti-mumps antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-mumps seroconversion rates (SCRs) at Day 42 after dose 1."||6.67|-3.04|
73940117|NCT01506193|147412495|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for rubella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.23|2.29||||||"Immune response for anti-rubella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-rubella seroconversion rates (SCRs) at Day 42 after dose 1."||2.29|-1.23|
73940118|NCT01506193|147412495|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for varicella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.33|||||TWO_SIDED|95.0|-1.87|2.03||||||"Immune response for anti-varicella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-varicella seroconversion rates (SCRs) at Day 42 after dose 1."||2.03|-1.87|
73973904|NCT03493542|147491350|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 11||1.2|-1.1|<0.0001
73973905|NCT03493542|147491350|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 16||1.2|-1.1|<0.0001
73973906|NCT03493542|147491350|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 18||1.2|-1.1|<0.0001
74031055|NCT00570739|147615651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.105||||0.4554|TWO_SIDED|95.0|-0.383|0.172||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.172|-0.383|0.4554
73973907|NCT04093869|147491359|SUPERIORITY||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|5.1||0.4|TWO_SIDED|95.0|-6.0|14.0||Not adjusted for multiple comparisons. Full alpha of 0.05 was allocated to this as the sole primary outcome.|Regression, Linear||A negative mean difference would represent a better outcome in the CSTEX arm compared to the SOC-ED arm.|||14|-6|0.40
73973908|NCT04093869|147491360|SUPERIORITY||Mean Difference (Net)|20.7|STANDARD_ERROR_OF_MEAN|32.6|||TWO_SIDED|95.0|-44.0|85.0|||||A positive value for the estimate represents a greater distance walked for the CSTEX arm compared to the SOC-ED arm.|||85|-44|
73973909|NCT04093869|147491361|SUPERIORITY||Median Difference (Net)|-316.0|STANDARD_ERROR_OF_MEAN|336.0|||TWO_SIDED|95.0|-979.0|346.0|||||A positive value for the estimate would represent more steps per day for the CSTEX arm compared to the SOC-ED arm.|||346|-979|
73973910|NCT04093869|147491362|SUPERIORITY||Mean Difference (Net)|14.7|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-5.0|34.0||||||||34|-5|
73973911|NCT04093869|147491363|SUPERIORITY||Mean Difference (Net)|0.0034|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.1|0.11|||||A negative value for the estimate would represent a better QOL survey score for the CSTEX arm compared to the SOC-ED arm.|||0.11|-0.1|
73973912|NCT04093869|147491364|SUPERIORITY||Mean Difference (Net)|0.041|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.22|0.3|||||A negative value for the estimate would represent a better Frailty index score for the CSTEX arm compared to the SOC-ED arm.|||0.30|-0.22|
73973913|NCT04093869|147491365|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.17||||||||0.17|-0.20|
73973914|NCT04093869|147491366|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.13|0.1||||||||0.10|-0.13|
74089002|NCT04146363|147731324|SUPERIORITY||Risk Difference (RD)|29.7|||<|1e-06|TWO_SIDED|95.0|21.6|37.8|||Cochran-Mantel-Haenszel|||||37.8|21.6|<0.000001
74089003|NCT04146363|147731325|SUPERIORITY||Risk Difference (RD)|42.0|||<|1e-06|TWO_SIDED|95.0|33.3|50.6|||Cochran-Mantel-Haenszel|||||50.6|33.3|<0.000001
74089004|NCT04146363|147731326|SUPERIORITY||Risk Difference (RD)|1.7||||0.218644|TWO_SIDED|95.0|-0.6|4.0|||Cochran-Mantel-Haenszel|||||4.0|-0.6|0.218644
74089005|NCT04146363|147731327|SUPERIORITY||Risk Difference (RD)|9.6||||0.000498|TWO_SIDED|95.0|5.7|13.6|||Cochran-Mantel-Haenszel|||||13.6|5.7|0.000498
74089006|NCT04146363|147731328|SUPERIORITY||Risk Difference (RD)|30.8|||<|1e-06|TWO_SIDED|95.0|22.1|39.4|||Cochran-Mantel-Haenszel|||||39.4|22.1|<0.000001
73867149|NCT04856904|147279461|SUPERIORITY||Bilateral difference|-2.7|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-3.8|-1.6|||Student's t-test for paired samples|||Week 16: Trifarotene 50 mcg/g, vehicle cream||-1.6|-3.8|< 0.0001
73940119|NCT01506193|147412496|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroresponse for rSBA-MenC was concluded if the lower limit of the 95% CI around the difference in seroprotection rates between groups would be \[-10%\] or higher.|Difference in percentage|-1.02|||||TWO_SIDED|95.0|-3.39|2.24||||||"Immune response for rSBA-MenC antibodies~Non-inferiority of Meningitec® conjugate vaccine co-administered with Priorix-Tetra™ compared to Meningitec® conjugate vaccine alone with respect to rabbit complement serum bactericidal assay (rSBA-MenC) antibody seroprotection rates (SPRs) at Day 42 after vaccination."||2.24|-3.39|
73940120|NCT04575467|147412511|SUPERIORITY||Mean absolute fat thickness difference|-4.77|STANDARD_DEVIATION|2.29|<|0.01|TWO_SIDED|95.0|-7.17|-2.37|||Paired t-test|||||-2.37|-7.17|<0.01
73940121|NCT04575467|147412511|SUPERIORITY||Mean absolute fat thickness difference|-4.85|STANDARD_DEVIATION|2.02|<|0.01|TWO_SIDED|95.0|-6.97|-2.73|||Paired t-test|||||-2.73|-6.97|<0.01
73940122|NCT04575467|147412511|SUPERIORITY||Mean absolute fat thickness difference|-2.98|STANDARD_DEVIATION|2.83|<|0.05|TWO_SIDED|95.0|-5.95|-0.01|||Paired t-test|||||-0.01|-5.95|<0.05
73940123|NCT04575467|147412512|SUPERIORITY||Mean absolute fat volume difference|-114.4|STANDARD_DEVIATION|54.88|<|0.01|TWO_SIDED|95.0|-171.99|-56.81|||Paired t-test|||||-56.81|-171.99|<0.01
73940124|NCT04575467|147412512|SUPERIORITY||Mean absolute fat volume difference|-155.2|STANDARD_DEVIATION|64.7|<|0.01|TWO_SIDED|95.0|-223.1|-87.3|||Paired t-test|||||-87.30|-223.10|<0.01
73940125|NCT04575467|147412512|SUPERIORITY||Mean absolute fat volume difference|-119.17|STANDARD_DEVIATION|113.11|<|0.05|TWO_SIDED|95.0|-237.86|-0.47|||Paired t-test|||||-0.47|-237.86|<0.05
74089007|NCT04146363|147731329|SUPERIORITY||Risk Difference (RD)|28.8|||<|1e-06|TWO_SIDED|95.0|21.3|36.3|||Cochran-Mantel-Haenszel|||||36.3|21.3|<0.000001
74089008|NCT04146363|147731330|SUPERIORITY||LS Mean Difference (Final Values)|-30.42|STANDARD_ERROR_OF_MEAN|3.915|<|1e-06|TWO_SIDED|95.0|-38.1|-22.7|||ANCOVA|||||-22.7|-38.1|<0.000001
74089009|NCT04146363|147731331|SUPERIORITY||Risk Difference (RD)|32.9|||<|1e-06|TWO_SIDED|95.0|24.6|41.3|||Cochran-Mantel-Haenszel|||||41.3|24.6|<0.000001
74089010|NCT04146363|147731332|SUPERIORITY||Risk Difference (RD)|35.1|||<|1e-06|TWO_SIDED|95.0|26.3|43.9|||Cochran-Mantel-Haenszel|||||43.9|26.3|<0.000001
73867150|NCT04856904|147279461|SUPERIORITY||Bilateral difference|-2.5|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Student's t-test for paired samples|||Week 20: Trifarotene 50 mcg/g, vehicle cream||-1.5|-3.5|< 0.0001
73867151|NCT01641822|147279472|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.743||||0.25|TWO_SIDED|95.0|0.446|1.238|||Negative binomial regression|||Ratio between rates||1.238|0.446|0.25
73940126|NCT01483924|147412529|SUPERIORITY_OR_OTHER|||||||0.9048|TWO_SIDED||||||ANOVA|||The difference in change in PASI score from baseline to Week 12 was compared all active treatment groups and the placebo group||||0.9048
73940127|NCT01483924|147412530|SUPERIORITY_OR_OTHER|||||||0.1975|TWO_SIDED||||||Cochran-Armitage trend test|||||||0.1975
73940128|NCT01483924|147412531|SUPERIORITY_OR_OTHER|||||||0.6349|TWO_SIDED||||||Kruskal-Wallis|||||||0.6349
73940129|NCT01483924|147412532|SUPERIORITY_OR_OTHER|||||||0.6212|TWO_SIDED||||||Kruskal-Wallis|||||||0.6212
73973915|NCT04093869|147491367|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.12|0.07||||||||0.07|-0.12|
73973916|NCT04093869|147491368|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-0.83|1.6|||||A positive value for the estimate represents better self-efficacy for the CSTEX arm compared to the SOC-ED arm.|||1.60|-0.83|
74089011|NCT04146363|147731333|SUPERIORITY||LS Mean Difference (Final Values)|-38.31|STANDARD_ERROR_OF_MEAN|4.151|<|1e-06|TWO_SIDED|95.0|-46.4|-30.2|||ANCOVA|||||-30.2|-46.4|<0.000001
74089012|NCT04146363|147731334|SUPERIORITY||LS Mean Difference (Final Values)|-18.5|STANDARD_ERROR_OF_MEAN|2.0|<|1e-06|TWO_SIDED|95.0|-22.4|-14.5|||Mixed Models Analysis|||||-14.5|-22.4|<0.000001
74089013|NCT04146363|147731335|SUPERIORITY||Risk Difference (RD)|10.7||||0.000412|TWO_SIDED|95.0|6.2|15.2|||Cochran-Mantel-Haenszel|||||15.2|6.2|0.000412
74089014|NCT04146363|147731336|SUPERIORITY||LS Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|0.68|<|1e-06|TWO_SIDED|95.0|-7.1|-4.5|||ANCOVA|||||-4.5|-7.1|<0.000001
74089015|NCT04146363|147731337|SUPERIORITY||Risk Difference (RD)|38.8|||<|1e-06|TWO_SIDED|95.0|28.3|49.3|||Cochran-Mantel-Haenszel|||||49.3|28.3|<0.000001
74089016|NCT04146363|147731338|SUPERIORITY||Risk Difference (RD)|41.8|||<|1e-06|TWO_SIDED|95.0|31.2|52.3|||Cochran-Mantel-Haenszel|||||52.3|31.2|<0.000001
74089017|NCT04146363|147731339|SUPERIORITY||LS Mean Difference (Final Values)|-32.35|STANDARD_ERROR_OF_MEAN|5.23|<|1e-06|TWO_SIDED|95.0|-42.6|-22.1|||ANCOVA|||||-22.1|-42.6|<0.000001
74089018|NCT04146363|147731340|SUPERIORITY||LS Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.098|<|1e-06|TWO_SIDED|95.0|-0.9|-0.6|||ANCOVA|||||-0.6|-0.9|<0.000001
74089019|NCT04146363|147731341|SUPERIORITY||Risk Difference (RD)|34.6|||<|1e-06|TWO_SIDED|95.0|26.2|43.0|||Cochran-Mantel-Haenszel|||||43.0|26.2|<0.000001
74089020|NCT04146363|147731342|SUPERIORITY||Risk Difference (RD)|1.5||||0.275529|TWO_SIDED|95.0|-0.8|3.9|||Cochran-Mantel-Haenszel|||||3.9|-0.8|0.275529
74089021|NCT04146363|147731343|SUPERIORITY||Risk Difference (RD)|5.3||||0.016656|TWO_SIDED|95.0|1.9|8.6|||Cochran-Mantel-Haenszel|||||8.6|1.9|0.016656
73940130|NCT03565887|147412550|SUPERIORITY|The primary efficacy endpoints were tested sequentially. The Day 1 Hour 6 time point was tested first and if P\<0.05, the Day 14 Hour 2 time point was tested at a significance level of 0.05. If the Day 1 Hour 6 endpoint is statistically significant (at the 0.05 level) but Day 14 Hour 2 was not statistically significant (at the 0.05 level), the study will still be considered positive.|||||<|0.0001||||||If both primary endpoints (LPFT) are significant at 0.05 significance level, then the secondary efficacy endpoints (MRD) were also tested sequentially. Testing stopped if a P≥ 0.05 for a comparison.|ANCOVA|2 sided t-test with treatment as fixed factor and baseline as covariate.||A two group t-test with a 0.05 two-sided significance level had 90% power to detect a difference in LPFT means of 3.50 assuming that the common standard deviation was 6.0, when the sample sizes in the 2 groups were 94 and 47, respectively (a total sample size of 141).||||<0.0001
73940131|NCT03565887|147412551|SUPERIORITY|If both primary endpoints (LPFT) are significant at 0.05 significance level, then the secondary efficacy endpoints (MRD) were also tested sequentially. Testing stopped if a P≥ 0.05 for a comparison.|||||<|0.0151|||||||ANCOVA|||A two group t-test with a 0.05 two-sided significance level had 90% power to detect a difference in LPFT means of 3.50 assuming that the common standard deviation was 6.0, when the sample sizes in the 2 groups were 94 and 47, respectively (a total sample size of 141).||||<0.0151
73973917|NCT04780581|147491390|EQUIVALENCE|log-rank statistic test.|Odds Ratio (OR)|1.0||||0.984|TWO_SIDED|95.0|0.2|5.1|||Log Rank|||Null hypothesis of equal survival curves. Estimates of rate and risk ratios are shown with 95% confidence intervals. All the p-values are 2-sided and shown without adjustment for multiple testing, and p \< 0.05 was considered statistically significant. The analyses were performed using IBM SPSS Statistics for Windows, Version 26.0 (Armonk, NY, USA: IBM Corp.).||5.1|0.2|0.984
73973918|NCT04780581|147491390|EQUIVALENCE|Log-rank method|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-8.8|9.1||||||||9.1|-8.8|
73973919|NCT04780581|147491391|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.1||||0.833|TWO_SIDED|95.0|0.4|3.0|||Chi-squared|||||3.0|0.4|0.833
73973920|NCT04780581|147491391|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-14.2|11.5||||||||11.5|-14.2|
73973921|NCT04780581|147491392|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.5||||0.661|TWO_SIDED|95.0|0.2|9.3|||Chi-squared|||non-invasive mechanical ventilation||9.3|0.2|0.661
73973922|NCT04780581|147491392|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|1.5|||||TWO_SIDED|95.0|-10.2|6.9||||||non-invasive mechanical ventilation||6.9|-10.2|
73973923|NCT04780581|147491392|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|0.7||||0.549|TWO_SIDED|95.0|0.2|2.2|||Chi-squared|||high-flow oxygen requirements||2.2|0.2|0.549
73973924|NCT04780581|147491392|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|-8.2|15.1||||||high-flow oxygen requirements||15.1|-8.2|
73973925|NCT04780581|147491392|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.1||||0.809|TWO_SIDED|95.0|0.4|3.3|||Chi-squared|||Invasive mechanical ventilation or intubation requirements analysis||3.3|0.4|0.809
73973926|NCT04780581|147491392|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-13.0|11.1||||||Invasive mechanical ventilation or intubation requirements analysis||11.1|-13.0|
73973927|NCT04780581|147491393|EQUIVALENCE|T-test|Risk Difference (RD)|-0.3||||0.908|TWO_SIDED|95.0|-5.0|5.0|||t-test, 1 sided|||||5|-5|0.908
73973928|NCT04780581|147491394|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|0.8||||0.758|TWO_SIDED|95.0|0.3|2.5|||Chi-squared|||Secondary infections||2.5|0.3|0.758
73973929|NCT04780581|147491394|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-10.1|13.7||||||Secondary infections||13.7|-10.1|
73973930|NCT04780581|147491394|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|4.2||||0.007|TWO_SIDED|95.0|1.4|12.3|||Chi-squared|||Hyperglycaemia||12.3|1.4|0.007
73973931|NCT04780581|147491394|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-18.9|||||TWO_SIDED|95.0|-31.8|-5.6||||||Hyperglycaemia||-5.6|-31.8|
73973932|NCT04780581|147491394|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.6||||0.319|TWO_SIDED|95.0|-8.5|4.4|||Chi-squared|||Psychotic states||4.4|-8.5|0.319
73973933|NCT04780581|147491395|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.0||||0.962|TWO_SIDED|95.0|0.4|2.3|||Chi-squared|||||2.3|0.4|0.962
73973934|NCT04780581|147491395|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-14.2|14.9||||||||14.9|-14.2|
73973935|NCT04734197|147491414|SUPERIORITY|||||||0.004||||||The threshold for statistical significance is p=0.05.|Fisher Exact|||Exploratory Phase 2 Study; the sample size of approximately 280-350 subjects (between 40 and 50 subjects per each of the 7 treatment groups) was based on medical judgement.||||0.0040
73973936|NCT04734197|147491415|SUPERIORITY|||||||0.3111|||||||Fisher Exact|The threshold for statistical significance is p=0.05.||"Mixed Model for Repeated Measures (MMRM) analysis included fixed effects of baseline TBUT, age, treatment, visit, and treatment by visit interaction.~Least squares means (LSMs) of the absolute TBUT change from baseline and their 95% CIs were estimated from the MMRM model for each treatment group."||||0.3111
73973937|NCT04734197|147491416|SUPERIORITY|||||||0.2027||||||The threshold for statistical significance is p=0.05.|Fisher Exact|||"MMRM analysis included fixed effects of baseline Schirmer test score, age, treatment, visit, and treatment by visit interaction.~LSMs of the absolute change from baseline in Schirmer test score and their 95% CIs were estimated from the MMRM model for each treatment group."||||0.2027
73973938|NCT04310423|147491417|OTHER|||||||0.036|||||||Mixed Models Analysis|||Treatment x Time interaction for alcohol cue-induced alcohol craving.||||0.036
73973939|NCT04310423|147491418|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Two-way Treatment x Time interaction||||>0.05
73973940|NCT04310423|147491419|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Treatment x Time interactions||||>0.05
73973941|NCT04310423|147491420|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Treatment x Time interactions||||>0.05
73973942|NCT04310423|147491421|OTHER||||||<|0.001|||||||ANCOVA|||Main effect of treatment on alcohol cue-elicited brain activation||||<0.001
73973943|NCT05785130|147491448|SUPERIORITY|T0|Mean Difference (Final Values)|-25.07||||0.74|TWO_SIDED|||||T0|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||0.74
73940132|NCT00449176|147412561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001||95.0|-1.22|-0.47|||ANCOVA|||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.||-0.47|-1.22|<0.001
73940133|NCT03015402|147412570|SUPERIORITY|Pre-randomization characteristics of 2 groups will be presented using the median (IQR) or frequency tables at each study sequence. The difference of mPAP during submax exercise compared between placebo and nitrite at 10 weeks (i.e. week 10 RHC of placebo vs week 10 RHC of nitrite) using parametric PK-cross analysis (i.e. ANOVA to determine the sequence, period, carryover, \& treatment effects). Post-exercise values before \& after crossover will be compared between 2 groups using similar approach.||||||0.2|||||||ANOVA|||||||0.20
73940134|NCT01995461|147412592|SUPERIORITY_OR_OTHER|||||||0.0252|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.0252
73940135|NCT01995461|147412593|SUPERIORITY_OR_OTHER|||||||0.0154|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.0154
73973944|NCT05785130|147491448|SUPERIORITY||Median Difference (Final Values)|133.57||||0.75|TWO_SIDED|||||T1|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||0.75
73973945|NCT05785130|147491448|SUPERIORITY|T|Median Difference (Final Values)|235.93|||<|0.01|TWO_SIDED|||||T2|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||<0.01
73973946|NCT05785130|147491448|SUPERIORITY|T3|Median Difference (Final Values)|214.18|||<|0.01|TWO_SIDED|||||T3|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||<0.01
73973947|NCT02532621|147491457|NON_INFERIORITY|"Cumulative patency at 6 months was evaluated using the estimated patency from a Kaplan Meier survival analysis. The test statistic took the following form:~Z-test statistic = (P - 0.75) / SE (P) Where, (P) represents the Kaplan Meier estimate of cumulative patency at 6 months, and the standard error SE (P) is estimated using the method of Peto et al (1977)."|Cumulative patency|92.1|||<|0.001|ONE_SIDED|95.0||||A one-sided p-value of 0.025 was considered evidence of statistical significance for the primary study endpoint.|one-sided binomial exact test|||"The primary endpoint was evaluated by comparison with a performance goal of 75% that was determined from medical literature.~The sample size of 158 patients was estimated as follows:~* Kaplan-Meier estimate of cumulative patency rate at 6 months (exact binomial estimation for sample size)~* Type I error (alpha): 0.025 (one-sided)~* 80% Statistical power~* 8% Lost-to-follow up rate"||||<0.001
73973948|NCT02360371|147491463|SUPERIORITY|||||||0.567|||||||Mixed methods|||||||0.567
73973949|NCT02360371|147491464|SUPERIORITY|||||||0.805|||||||Mixed Model|||||||0.805
73973950|NCT04881110|147491480|SUPERIORITY||Mean Difference (Final Values)|11.2|||<|0.001|TWO_SIDED|95.0|8.0|14.5|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|14.5|8.0|<0.001
73973951|NCT04881110|147491480|SUPERIORITY||Risk Ratio (RR)|1.91|||<|0.001|TWO_SIDED|95.0|1.26|2.9|||Chi-squared||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.90|1.26|<0.001
74008403|NCT03627767|147566508|SUPERIORITY||LSM difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.0|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.0|-1.7|< 0.0001
74089022|NCT04146363|147731344|SUPERIORITY||Risk Difference (RD)|19.3||||3e-06|TWO_SIDED|95.0|13.7|25.0|||Cochran-Mantel-Haenszel|||||25.0|13.7|0.000003
74008404|NCT03627767|147566508|SUPERIORITY||LSM difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.8|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.8|-2.5|< 0.0001
74008405|NCT03627767|147566508|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.5|-1.1|
74008406|NCT03627767|147566508|SUPERIORITY||LSM difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.4|< 0.0001
73940136|NCT01995461|147412594|SUPERIORITY_OR_OTHER|||||||0.1349|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.1349
73940137|NCT00736645|147412596|OTHER|||||||0.5137|||||||Wilcoxon (Mann-Whitney)|||||||0.5137
73973952|NCT04881110|147491481|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.06|TWO_SIDED|95.0|-0.8|0.01|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.01|-0.8|0.06
73940138|NCT00736645|147412596|OTHER|||||||0.8994|||||||Wilcoxon (Mann-Whitney)|||||||0.8994
73940139|NCT00736645|147412596|OTHER|||||||0.3463|||||||Wilcoxon (Mann-Whitney)|||||||0.3463
73940140|NCT00736645|147412597|OTHER|||||||0.2609|||||||Wilcoxon (Mann-Whitney)|||||||0.2609
73940141|NCT00736645|147412597|OTHER|||||||0.7504|||||||Wilcoxon (Mann-Whitney)|||||||0.7504
73940142|NCT00736645|147412597|OTHER|||||||0.9727|||||||Wilcoxon (Mann-Whitney)|||||||0.9727
73940143|NCT00295022|147412608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12|||<|0.001|TWO_SIDED|95.0|-4.35|-1.88|||ANCOVA|||||-1.88|-4.35|<0.001
73940144|NCT00295022|147412608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||=|0.001|TWO_SIDED|95.0|-2.04|0.18|||ANCOVA|||||0.18|-2.04|=0.001
73940145|NCT00295022|147412608|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.19|||<|0.001|TWO_SIDED|95.0|-3.43|-0.95|||ANCOVA|||||-0.95|-3.43|<0.001
73940146|NCT01201057|147412644|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|||||||0.006
73940147|NCT01201057|147412645|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73940148|NCT01201057|147412646|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||||||0.025
73940149|NCT03240692|147412664|OTHER|||||||0.036||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and frontal Default Mode Network (fDMN) functional connectivity||||0.036
73940150|NCT03240692|147412664|OTHER|||||||0.008||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and medial Default Mode Network (mDMN) functional connectivity||||0.008
73940151|NCT03240692|147412664|OTHER|||||||0.06||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and left Default Mode Network (lDMN) functional connectivity.||||0.06
73940152|NCT03240692|147412664|OTHER|||||||0.017||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and right Default Mode Network (rDMN) functional connectivity.||||0.017
74031056|NCT00570739|147615652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8583|TWO_SIDED|95.0|-10.7|8.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||8.9|-10.7|0.8583
73940153|NCT02300220|147412666|SUPERIORITY||Cox Proportional Hazard|1.071||||0.764|TWO_SIDED|95.0|0.684|1.676|||Regression, Cox|||The primary endpoint was assessed using a Cox's proportional hazard model with pre-specified adjustment for patient's self-reported history of exacerbations over the previous year and with stratification for study centre. The onset of exacerbation will be monitored up to 90 days or at patient withdrawal.||1.676|0.684|0.764
73940154|NCT02300220|147412667|SUPERIORITY|||||||0.703|||||||Wilcoxon (Mann-Whitney)|||||||0.703
73940155|NCT02300220|147412669|SUPERIORITY|||||||0.239|||||||t-test, 2 sided|||||||0.239
73940156|NCT04322682|147412672|SUPERIORITY||Odds Ratio (OR)|0.79||||0.081|TWO_SIDED|95.1|0.61|1.03|||Chi-squared|||||1.03|0.61|0.081
73940157|NCT04322682|147412673|SUPERIORITY||Odds Ratio (OR)|0.56||||0.291|TWO_SIDED|95.0|0.19|1.67|||Chi-squared|||||1.67|0.19|0.291
73940158|NCT04322682|147412674|SUPERIORITY||Odds Ratio (OR)|0.79||||0.077|TWO_SIDED|95.0|0.6|1.03|||Chi-squared|||||1.03|0.60|0.077
73940159|NCT04322682|147412675|SUPERIORITY||Odds Ratio (OR)|0.53||||0.08|TWO_SIDED|95.0|0.25|1.09|||Chi-squared|||||1.09|0.25|0.080
73940160|NCT04322682|147412676|SUPERIORITY||Odds Ratio (OR)|0.75||||0.042|TWO_SIDED|95.0|0.57|0.99||P-Value is for the comparison of the treatment group within patients with Covid-19 confirmed by PCR.|Regression, Logistic|Logistic-regression model including the treatment group, the PCR-confirmed Covid-19 subgroup factor (yes/no) and their interaction was performed.||||0.99|0.57|0.042
73940161|NCT02238379|147412687|SUPERIORITY_OR_OTHER|||||||0.003||||||Main Effect of Emotion|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis||||.003
73940162|NCT02238379|147412687|SUPERIORITY_OR_OTHER|||||||0.034||||||Main Effect of Face Type|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis||||.034
73940163|NCT02238379|147412687|SUPERIORITY_OR_OTHER|||||||0.03||||||Main Effect of Face Type|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis||||.03
73940164|NCT02238379|147412687|SUPERIORITY_OR_OTHER|||||||0.03||||||Spray Type by Face Type Interaction|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis||||.03
73940165|NCT02238379|147412687|SUPERIORITY_OR_OTHER||||||>|0.22||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||LPP Analysis||||>.22
73940166|NCT02238379|147412688|SUPERIORITY_OR_OTHER||||||>|0.14||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) and Hemisphere (left, right) ANOVA||N170 Analysis||||>.14
73940167|NCT02238379|147412688|SUPERIORITY_OR_OTHER||||||>|0.17||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||P300 Analysis||||>.17
73940168|NCT02238379|147412688|SUPERIORITY_OR_OTHER||||||>|0.27||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||LPP Analysis||||>.27
73940169|NCT02238379|147412689|SUPERIORITY_OR_OTHER|||||||0.006||||||Main Effect of Emotion|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170||||.006
73940170|NCT02238379|147412689|SUPERIORITY_OR_OTHER|||||||0.01||||||Main Effect of Hemisphere|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170||||.01
73867152|NCT01641822|147279473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.16|TWO_SIDED|95.0|-0.55|3.2||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in FEV1 % predicted||3.2|-0.55|0.16
73867153|NCT01641822|147279474|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||Comparison of percentages||||0.67
73940171|NCT02238379|147412690|SUPERIORITY_OR_OTHER|||||||0.03||||||Main Effect of Spray|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170||||.03
73940172|NCT02238379|147412690|SUPERIORITY_OR_OTHER|||||||0.008||||||Main Effect of Hemisphere|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170||||.008
73940173|NCT02238379|147412691|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
73940174|NCT02238379|147412693|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
73940175|NCT02238379|147412694|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
73940176|NCT02238379|147412695|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
73940177|NCT00605280|147412737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0047|TWO_SIDED|95.0|1.32|4.3||Adjusted for glycolated hemoglobin (HbA1c), systolic blood pressure (BP), diastolic BP, and baseline VA. Baseline values not carried forward for missing post-baseline data.|Cochran-Mantel-Haenszel|||||4.30|1.32|0.0047
73940178|NCT00605280|147412738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.1904|TWO_SIDED|95.0|0.85|2.53|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||2.53|0.85|0.1904
73940179|NCT00605280|147412739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.2466|TWO_SIDED|95.0|0.74|3.34|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||3.34|0.74|0.2466
73940180|NCT00605280|147412740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.1388|TWO_SIDED|95.0|0.86|3.26|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||3.26|0.86|0.1388
74031057|NCT00570739|147615652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.7975|TWO_SIDED|95.0|-10.5|8.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||8.1|-10.5|0.7975
74031058|NCT00570739|147615653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0||||0.233||95.0|-18.5|4.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||4.5|-18.5|0.2330
74031059|NCT00570739|147615653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.1412|TWO_SIDED|95.0|-19.2|2.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||2.8|-19.2|0.1412
74031060|NCT00570739|147615654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.8192|TWO_SIDED|95.0|-13.7|10.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||10.8|-13.7|0.8192
74031061|NCT00570739|147615654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.7513|TWO_SIDED|95.0|-13.5|9.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||9.7|-13.5|0.7513
73940181|NCT00605280|147412741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0468|TWO_SIDED|95.0|0.07|0.99|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.99|0.07|0.0468
73940182|NCT00605280|147412742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.1124|TWO_SIDED|95.0|0.73|11.55|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||11.55|0.73|0.1124
73940183|NCT00605280|147412743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.1788|TWO_SIDED|95.0|0.16|1.42|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||1.42|0.16|0.1788
74031062|NCT00570739|147615655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.91||||0.4301|TWO_SIDED|95.0|-24.156|10.336||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||10.336|-24.156|0.4301
74031063|NCT00570739|147615655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17||||0.5369|TWO_SIDED|95.0|-21.661|11.321||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||11.321|-21.661|0.5369
74031064|NCT00570739|147615656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.151||||0.7447|TWO_SIDED|95.0|-1.068|0.765||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.765|-1.068|0.7447
74031065|NCT00570739|147615656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.9476|TWO_SIDED|95.0|-0.853|0.911||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.911|-0.853|0.9476
74089023|NCT04146363|147731345|SUPERIORITY||Risk Difference (RD)|1.8||||0.244105|TWO_SIDED|95.0|-0.8|4.3|||Cochran-Mantel-Haenszel|||||4.3|-0.8|0.244105
74089024|NCT04146363|147731346|SUPERIORITY||Risk Difference (RD)|5.8||||0.01445|TWO_SIDED|95.0|2.2|9.4|||Cochran-Mantel-Haenszel|||||9.4|2.2|0.014450
74089025|NCT04146363|147731347|SUPERIORITY||Risk Difference (RD)|20.9||||2e-06|TWO_SIDED|95.0|14.9|26.9|||Cochran-Mantel-Haenszel|||||26.9|14.9|0.000002
74089026|NCT04146363|147731348|SUPERIORITY||LS Mean Difference (Final Values)|-30.29|STANDARD_ERROR_OF_MEAN|3.203|<|1e-06|TWO_SIDED|95.0|-36.59|-24.0|||ANCOVA|||||-24.00|-36.59|<0.000001
74089027|NCT04146363|147731350|SUPERIORITY||Risk Difference (RD)|17.9||||0.072375|TWO_SIDED|95.0|-2.3|38.1|||Cochran-Mantel-Haenszel|||||38.1|-2.3|0.072375
73867154|NCT01641822|147279475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.71|TWO_SIDED|95.0|0.5|1.59|||Log Rank|||Comparison of time to exacerbation||1.59|0.50|0.71
73867155|NCT01641822|147279476|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.642||||0.14|TWO_SIDED|95.0|0.355|1.164|||Negative binomial regression|||Comparison of hospitalization rate||1.164|0.355|0.14
73867156|NCT01641822|147279477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06||||0.21|TWO_SIDED|95.0|-1.71|7.82||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in CFQ-R RSS||7.82|-1.71|0.21
73867157|NCT00599638|147279480|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.306||0.391|TWO_SIDED|80.0|-0.31|0.48|||Mixed Models Analysis|||||0.48|-0.31|0.3910
73867158|NCT00599638|147279480|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.357||0.0002|TWO_SIDED|80.0|-1.78|-0.86|||Mixed Models Analysis|||||-0.86|-1.78|0.0002
73940184|NCT00605280|147412744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.12||||0.0048|TWO_SIDED|95.0|1.45|18.06|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||18.06|1.45|0.0048
73940185|NCT00605280|147412745|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean|3.9||||0.004|TWO_SIDED|95.0|1.25|6.54|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||6.54|1.25|0.0040
73940186|NCT00605280|147412746|SUPERIORITY_OR_OTHER||LS Mean|4.57||||0.0011|TWO_SIDED|95.0|1.85|7.29|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post baseline data.||||7.29|1.85|0.0011
73940187|NCT00605280|147412747|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.0023|TWO_SIDED|95.0|0.24|0.74|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.74|0.24|0.0023
74031066|NCT00570739|147615657|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||<0.0001
73867159|NCT00599638|147279481|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0055||||0.4959|TWO_SIDED|80.0|0.3|1.71|||Regression, Logistic|||The statistical analysis was performed compositely for all categories.||1.71|0.30|0.4959
73867160|NCT00599638|147279481|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.0763||||0.0011|TWO_SIDED|80.0|1.69|8.46|||Regression, Logistic|||The statistical analysis was performed compositely for all categories.||8.46|1.69|0.0011
73940188|NCT00605280|147412748|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.0008|TWO_SIDED|95.0|0.23|0.69|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.69|0.23|0.0008
73940189|NCT01662882|147412749|SUPERIORITY_OR_OTHER|||||||0.0253||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0253
73940190|NCT01662882|147412749|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0004
73940191|NCT01662882|147412749|SUPERIORITY_OR_OTHER|||||||0.4184||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.4184
73940192|NCT01662882|147412749|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0008
73867161|NCT00599638|147279483|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|1.18|STANDARD_ERROR_OF_MEAN|2.819||0.338|TWO_SIDED|80.0|-2.47|4.84|||Mixed Models Analysis|||||4.84|-2.47|0.3380
73867162|NCT00599638|147279483|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-9.65|STANDARD_ERROR_OF_MEAN|3.268||0.0022|TWO_SIDED|80.0|-13.89|-5.42|||Mixed Models Analysis|||||-5.42|-13.89|0.0022
73867163|NCT03037983|147279567|SUPERIORITY||Mean Difference (Net)|1.38||||0.849|TWO_SIDED||||||t-test, 2 sided|||||||.849
73867164|NCT03037983|147279569|SUPERIORITY||Mean Difference (Net)|0.5||||0.782|TWO_SIDED|||||t = 0.287|t-test, 2 sided|||||||.782
73867165|NCT03262441|147279669|OTHER||Slope|-0.00033|||||TWO_SIDED|95.0|-0.002|0.0014||||||||0.0014|-0.0020|
73867166|NCT03262441|147279670|OTHER||Slope|0.001|||||TWO_SIDED|95.0|-0.0036|0.0056||||||||0.0056|-0.0036|
73867167|NCT03262441|147279671|OTHER||Slope|0.0024|||||TWO_SIDED|95.0|-0.003|0.0078||||||||0.0078|-0.003|
73867168|NCT00605345|147279748|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was met if the lower limit of the confidence interval for the response rate of the CERA group was greater than the observed response rate of the darbepoetin group minus 15%. The calculated lower limit of an acceptable difference in response rates thus, was based on the actual percentage of responders in the darbepoetin group and this percentage minus 15% had to be excluded."||||||0.5947|||||||Fisher Exact|||||||0.5947
73867169|NCT00238238|147279758|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher Exact|||||||0.29
73867170|NCT00238238|147279759|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|||||||0.002
73940193|NCT01662882|147412750|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.||||0.0039
73940194|NCT01662882|147412750|SUPERIORITY_OR_OTHER|||||||0.0357||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0357
73940195|NCT01662882|147412750|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0010
73940196|NCT01662882|147412750|SUPERIORITY_OR_OTHER|||||||0.2118||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.2118
73940197|NCT00205348|147412812|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Burden was tested with the Wilcoxon signed-rank test.||||0.0007
73940198|NCT00205348|147412812|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Physical was tested with the Wilcoxon signed-rank test.||||<0.0001
74031067|NCT00570739|147615657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23||||0.0018|TWO_SIDED|95.0|2.06|13.58||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||13.58|2.06|0.0018
73867171|NCT01345669|147279760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.126||||0.4806|TWO_SIDED|95.0|0.809|1.569|||Log Rank||Hazard ratio (Afatinib vs. Placebo) from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|DFS was analysed using a stratified log-rank test with nodal status (N0- N2a vs. N2b-N3) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) being the stratification factors.||1.569|0.809|0.4806
73867172|NCT01345669|147279761|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimates|-6.27||||0.161|TWO_SIDED|95.0|-15.04|2.5|||Log Rank||Difference in Kaplan-Meier estimates of Afatinib vs. Placebo is provided.|Kaplan-Meier (KM) curves were calculated for each treatment group, separately, and the estimates of DFS probabilities from the curves and 95% Confidence interval (CI) (using the Greenwood standard error estimate) were tabulated||2.50|-15.04|0.1610
73867173|NCT01345669|147279762|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.444||||0.1301|TWO_SIDED|95.0|0.895|2.332||p-value (two-sided) from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||2.332|0.895|0.1301
73867174|NCT01345669|147279763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.431||||0.0561|TWO_SIDED|95.0|0.991|2.068|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Swallowing (Q5-Q8 from QLQ-HN35).||2.068|0.991|0.0561
73867175|NCT01345669|147279763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.446||||0.0523|TWO_SIDED|95.0|0.996|2.098|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Pain HN35 (Q1-Q4 from QLQ-HN35).||2.098|0.996|0.0523
73867176|NCT01345669|147279763|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.818||||0.257|TWO_SIDED|95.0|0.577|1.158|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Global health status/QoL(Q29-Q30 from QLQ-C30).||1.158|0.577|0.2570
73940199|NCT00205348|147412812|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Mental was tested with the Wilcoxon signed-rank test.||||0.0002
73940200|NCT00205348|147412812|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fear was tested with the Wilcoxon signed-rank test.||||<0.0001
73940201|NCT00205348|147412812|SUPERIORITY_OR_OTHER|||||||0.0973|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Desire was tested with the Wilcoxon signed-rank test.||||0.0973
73940202|NCT00205348|147412812|SUPERIORITY_OR_OTHER|||||||0.1772|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Duration was tested with the Wilcoxon signed-rank test.||||0.1772
73940203|NCT00205348|147412812|SUPERIORITY_OR_OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Food Selection was tested with the Wilcoxon signed-rank test.||||0.0062
73940204|NCT00205348|147412812|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Sleep was tested with the Wilcoxon signed-rank test.||||<0.0001
73867177|NCT01345669|147279764|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.295||||0.0591|TWO_SIDED|95.0|0.986|1.7||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For swallowing scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||1.700|0.986|0.0591
73940205|NCT00205348|147412812|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fatigue was tested with the Wilcoxon signed-rank test.||||0.0002
73940206|NCT00205348|147412812|SUPERIORITY_OR_OTHER|||||||0.2125|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Social was tested with the Wilcoxon signed-rank test.||||0.2125
73867178|NCT01345669|147279764|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.456||||0.0049|TWO_SIDED|95.0|1.113|1.905||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For pain HN35 scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||1.905|1.113|0.0049
73867179|NCT01345669|147279764|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.604||||0.0002|TWO_SIDED|95.0|1.238|2.079||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For global health status/QoL scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||2.079|1.238|0.0002
73940207|NCT00205348|147412812|SUPERIORITY_OR_OTHER|||||||0.0332|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Communication was tested with the Wilcoxon signed-rank test.||||0.0332
73940208|NCT01311674|147412818|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
73940209|NCT01311674|147412819|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
73940210|NCT01311674|147412820|SUPERIORITY|||||||0.84|||||||Log Rank|||||||0.84
73940211|NCT01311674|147412821|SUPERIORITY|||||||0.24|||||||Log Rank|||||||0.24
73940212|NCT01311674|147412822|SUPERIORITY|||||||0.27|||||||Log Rank|||||||0.27
74008407|NCT03627767|147566508|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.4|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.4|-2.2|< 0.0001
74089028|NCT04146363|147731350|SUPERIORITY||Risk Difference (RD)|17.5||||0.106653|TWO_SIDED|95.0|-4.5|39.5|||Cochran-Mantel-Haenszel|||||39.5|-4.5|0.106653
74089029|NCT04146363|147731351|SUPERIORITY||Risk Difference (RD)|28.0||||0.029857|TWO_SIDED|95.0|2.8|53.2|||Cochran-Mantel-Haenszel|||||53.2|2.8|0.029857
74089030|NCT04146363|147731351|SUPERIORITY||Risk Difference (RD)|29.0||||0.019744|TWO_SIDED|95.0|4.6|53.3|||Cochran-Mantel-Haenszel|||||53.3|4.6|0.019744
74089031|NCT04146363|147731352|SUPERIORITY||Risk Difference (RD)|15.8||||0.268265|TWO_SIDED|95.0|-12.2|43.8|||Cochran-Mantel-Haenszel|||||43.8|-12.2|0.268265
73940213|NCT00450411|147412829|OTHER|||||||||||||||||It was projected that ≤10% of patients would experience late treatment-related GI/GU AEs under the protocol treatment (alternative hypothesis). A rate of ≥20% was considered unacceptable (null hypothesis). With a one-sided significance level of 0.05, it was estimated that 87 analyzable patients were required to detect the above-mentioned effect size with an 85% statistical power using Fleming's multiple testing procedure with two interim analyses and one final analysis.|Stopping Rules for a Late GI/GU Adverse Event: For 44 patients, if ≤2 then reject H0, if ≥8 then reject HA; for 73 patients, if ≤7 then reject H0, if ≥10 then reject HA; for 87 patients, if ≤10 then reject H0, if ≥11 then reject HA.|||
73940214|NCT03969719|147412843|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-12.44||||0.0696|TWO_SIDED|90.0|-22.37|-1.25|||ANCOVA|||||-1.25|-22.37|0.0696
73940215|NCT03969719|147412843|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-14.64||||0.0288|TWO_SIDED|90.0|-24.18|-3.89|||ANCOVA|||||-3.89|-24.18|0.0288
73940216|NCT03969719|147412844|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-0.08||||0.6336|TWO_SIDED|90.0|-0.36|0.2|||Mixed Models Analysis|||||0.20|-0.36|0.6336
73973953|NCT04881110|147491482|SUPERIORITY||Mean Difference (Final Values)|-3.4||||0.52|TWO_SIDED|95.0|-14.3|7.4|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|7.4|-14.3|0.52
73940217|NCT03969719|147412844|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-0.25||||0.1266|TWO_SIDED|90.0|-0.52|0.02|||Mixed Models Analysis|||||0.02|-0.52|0.1266
73940218|NCT04184791|147412856|OTHER|A linear mixed-effects analysis of variance (LM-ANOVA) model was used to determine the effect of L-Dopa, frequency, the interaction of levodopa and frequency, and the interaction of frequency and contact pairs on gait parameters. The fixed effects were L-Dopa condition (ON vs. OFF), stimulation frequency (LFS;60 Hz vs. HFS;180 Hz), contact pairs \[1-(R)/1-(L); 2-(R)/2-(L); 3-(R)/3-(L); 4-(R)/4-(L)\], and assistive device (presence vs. absence) and the patient effect was considered random.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73940219|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.87|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.87
73940220|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.78|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.78
73940221|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.67|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.67
73940222|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.52|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.52
74031068|NCT00570739|147615657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.46||||0.0019|TWO_SIDED|95.0|1.89|10.54||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||10.54|1.89|0.0019
74031069|NCT00570739|147615657|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.0005
74031070|NCT00570739|147615657|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.0007
73940223|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.39|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.39
73940224|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.26|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.26
73940225|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.31|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.31
73940226|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.22|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.22
74031071|NCT00570739|147615658|SUPERIORITY_OR_OTHER|||||||0.0104||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.0104
74031072|NCT00570739|147615658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.2224|TWO_SIDED|95.0|0.53|9.39||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||9.39|0.53|0.2224
73940227|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.14|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.14
73940228|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.09|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.09
73940229|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.05|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.05
73940230|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.03|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.03
73940231|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.85|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.85
73940232|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.79|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.79
73940233|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.71|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.71
73940234|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.61|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.61
73940235|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.51|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.51
73940236|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.41|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.41
74031073|NCT00570739|147615658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.199|TWO_SIDED|95.0|0.53|9.33||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||9.33|0.53|0.1990
73940237|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.47|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.47
73940238|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.36|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.36
73940239|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.26|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.26
73940240|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.19|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.19
73940241|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.13|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.13
73940242|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.09|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.09
73940243|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.78|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.78
74031074|NCT00570739|147615658|SUPERIORITY_OR_OTHER|||||||0.2778||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2778
74031075|NCT00570739|147615658|SUPERIORITY_OR_OTHER|||||||0.2785||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.2785
73940244|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.69|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.69
73940245|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.59|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.59
73940246|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.5|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.50
73973954|NCT04881110|147491483|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.33|TWO_SIDED|95.0|-3.6|1.2|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|1.2|-3.6|0.33
73973955|NCT04881110|147491484|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.1|TWO_SIDED|95.0|-1.7|0.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.1|-1.7|0.10
73973956|NCT04881110|147491485|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.81|TWO_SIDED|95.0|-2.8|3.5|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|3.5|-2.8|0.81
73973957|NCT04881110|147491486|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.99|TWO_SIDED|95.0|-5.8|5.8|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|5.8|-5.8|0.99
73973958|NCT04881110|147491487|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.72|TWO_SIDED|95.0|-32.6|22.9|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|22.9|-32.6|0.72
73973959|NCT04881110|147491488|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.02|TWO_SIDED|95.0|-0.7|-0.07|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|-0.07|-0.7|0.02
73973960|NCT04881110|147491489|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.12|TWO_SIDED|95.0|-0.04|0.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.3|-0.04|0.12
74008408|NCT03627767|147566508|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.5|-1.1|
73940247|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.39|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.39
73940248|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.3|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.30
73867180|NCT01345669|147279765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.08||0.2232|TWO_SIDED|95.0|-0.81|3.45|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (swallowing scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||3.45|-0.81|0.2232
73867181|NCT01345669|147279765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.08||0.0028|TWO_SIDED|95.0|1.12|5.36|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (pain scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||5.36|1.12|0.0028
73940249|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.68|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.68
73940250|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.59|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.59
73940251|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.5|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.50
73940252|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.4|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.40
73940253|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.3|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.30
73940254|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.22|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.22
73940255|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.41|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.41
73940256|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.32|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.32
73940257|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.24|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.24
73940258|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.16|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.16
73940259|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.11|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.11
73940260|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.07|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.07
73940261|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.41|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.41
73940262|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.32|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.32
74031076|NCT00570739|147615659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.5353|TWO_SIDED|95.0|-2.84|1.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||1.48|-2.84|0.5353
73867182|NCT01345669|147279765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.98||0.0005|TWO_SIDED|95.0|-5.33|-1.49|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (global health/QoL) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||-1.49|-5.33|0.0005
73940263|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.25|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.25
73940264|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.18|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.18
73940265|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.12|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.12
73940266|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.07|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.07
73940267|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.45|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.45
73940268|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.37|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.37
73940269|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.3|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.30
73940270|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.22|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.22
73940271|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.17|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.17
73940272|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.12|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.12
73940273|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.72|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.72
73940274|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.65|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.65
73940275|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.57|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.57
73940276|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.48|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.48
73940277|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.39|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.39
74089032|NCT04146363|147731352|SUPERIORITY||Risk Difference (RD)|16.6||||0.192776|TWO_SIDED|95.0|-9.4|42.7|||Cochran-Mantel-Haenszel|||||42.7|-9.4|0.192776
74089033|NCT04146363|147731353|SUPERIORITY||Risk Difference (RD)|18.6||||0.185361|TWO_SIDED|95.0|-9.3|46.6|||Cochran-Mantel-Haenszel|||||46.6|-9.3|0.185361
74089034|NCT04146363|147731353|SUPERIORITY||Risk Difference (RD)|16.6||||0.192776|TWO_SIDED|95.0|-9.4|42.7|||Cochran-Mantel-Haenszel|||||42.7|-9.4|0.192776
74089035|NCT04146363|147731354|SUPERIORITY||LS Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|4.756||0.714208|TWO_SIDED|95.0|-11.15|7.66|||ANCOVA|||||7.66|-11.15|0.714208
74089036|NCT04146363|147731354|SUPERIORITY||LS Mean Difference (Final Values)|-5.63|STANDARD_ERROR_OF_MEAN|4.4748||0.237855|TWO_SIDED|95.0|-15.01|3.76|||ANCOVA|||||3.76|-15.01|0.237855
74089037|NCT04146363|147731355|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|1e-06|TWO_SIDED|95.0|0.1|0.2|||ANCOVA|||UK||0.2|0.1|<0.000001
73940278|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.3|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.30
73940279|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.76|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.76
73940280|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.71|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.71
73940281|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.65|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.65
73940282|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.59|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.59
73940283|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.53|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.53
73940284|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.46|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.46
74031077|NCT00570739|147615659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.5475|TWO_SIDED|95.0|-2.64|1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.40|-2.64|0.5475
74031078|NCT00570739|147615660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0116||||0.0678|TWO_SIDED|95.0|-0.0241|0.0009||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.0009|-0.0241|0.0678
74031079|NCT00570739|147615660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0112||||0.0585|TWO_SIDED|95.0|-0.0228|0.0004||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.0004|-0.0228|0.0585
74089038|NCT04146363|147731355|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.01|<|1e-06|TWO_SIDED|95.0|0.1|0.1|||ANCOVA|||US||0.1|0.1|<0.000001
74089039|NCT04146363|147731356|SUPERIORITY||LS Mean Difference (Final Values)|8.3|STANDARD_ERROR_OF_MEAN|1.66|<|1e-06|TWO_SIDED|95.0|5.0|11.5|||ANCOVA|||||11.5|5.0|<0.000001
73867183|NCT01793883|147279766|SUPERIORITY|||||||0.251|||||||Log Rank|||||||0.251
73940285|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.68|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.68
74089040|NCT04146363|147731357|SUPERIORITY||LS Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|0.8|<|1e-06|TWO_SIDED|95.0|-8.9|-5.7|||Mixed Models Analysis|||||-5.7|-8.9|<0.000001
74089041|NCT04146363|147731358|SUPERIORITY||LS Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|2.917||0.716224|TWO_SIDED|95.0|-6.93|4.8|||ANCOVA|||||4.80|-6.93|0.716224
74089042|NCT04146363|147731359|SUPERIORITY||LS Mean Difference (Final Values)|-4.51|STANDARD_ERROR_OF_MEAN|2.599||0.089275|TWO_SIDED|95.0|-9.73|0.72|||ANCOVA|||||0.72|-9.73|0.089275
74089043|NCT04146363|147731360|SUPERIORITY||LS Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|0.796||4e-05|TWO_SIDED|95.0|-4.88|-1.75|||ANCOVA|||||-1.75|-4.88|0.000040
74089044|NCT04146363|147731361|SUPERIORITY||LS Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.697||0.000127|TWO_SIDED|95.0|-4.07|-1.33|||ANCOVA|||||-1.33|-4.07|0.000127
73940286|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.61|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.61
73940287|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.55|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.55
73973961|NCT04881110|147491490|SUPERIORITY||Mean Difference (Final Values)|-3.09||||0.25|TWO_SIDED|95.0|-8.5|2.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.3|-8.5|0.25
73973962|NCT04881110|147491491|SUPERIORITY||Mean Difference (Final Values)|87.4|||<|0.001|TWO_SIDED|95.0|59.9|115.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|115.1|59.9|<0.001
73973963|NCT04881110|147491492|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.18|TWO_SIDED|95.0|-0.09|0.01|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.01|-0.09|0.18
73940288|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.46|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.46
73973964|NCT04881110|147491493|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.06|TWO_SIDED|95.0|-0.6|18.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|18.1|-0.6|0.06
73973965|NCT04881110|147491494|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.06|TWO_SIDED|95.0|-0.09|2.6|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.6|-0.09|0.06
73973966|NCT04881110|147491496|SUPERIORITY||Mean Difference (Final Values)|25.1|||<|0.001|TWO_SIDED|95.0|21.8|28.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|28.3|21.8|<0.001
73973967|NCT02933489|147491529|EQUIVALENCE|H0: DBT = AB-MR|Wald interval with Bonett-Price Laplace|0.007||||0.002|TWO_SIDED|95.0|0.0022|0.0116|||McNemar||"Wald interval with Bonett-Price Laplace, described in :~Fagerland MW, Lydersen S, Laake P. Recommended tests and confidence intervals for paired binomial proportions. Statist. Med. 2014; 33:2850-75."|The proportion of participants who had an invasive cancer, verified by pathology, detected by each modality (the invasive cancer detection rates) will be made using exact McNemar's test.||0.0116|0.0022|0.002
73973968|NCT02933489|147491530|EQUIVALENCE|PPV DBT = PPV AB-MR||||||0.15||||||"Generalized estimating equation (GEE) regression with the p-value from the resulting score test.~5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance"|Leisenring|Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of binary medical diagnostic tests for paired designs. Biometrics. 2000;56:345-351||Positive Predictive Value (PPV)||||0.15
73973969|NCT02933489|147491531|EQUIVALENCE|H0: DBT short term follow-up rate = AB-MR short term follow-up rate|||||<|0.0001||||||To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5=0.01 corresponding to the 5 secondary comparisons outlined in the Statistical Analysis Plan (SAP)|McNemar|exact p-value||The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR short term follow-up rates||||<0.0001
74031080|NCT00570739|147615661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.7051|TWO_SIDED|95.0|-18.64|12.64||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||12.64|-18.64|0.7051
73973970|NCT02933489|147491531|EQUIVALENCE|H0: DBT additional imaging rate =AB-MR additional imaging rate||||||0.02||||||To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5 = 0.01, corresponding to the 5 secondary comparisons outlined in the SAP|McNemar|exact p-values||The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR additional imaging rates||||0.02
73973971|NCT02933489|147491532|EQUIVALENCE|Sensitivity DBT = Sensitivity AB-MR||||||0.001||||||The comparison of the sensitivity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance|McNemar|||||||0.001
73940289|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.4|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.40
73940290|NCT02130193|147412877|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.33|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.33
73940291|NCT02130193|147412881|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.013|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.013
73940292|NCT02130193|147412881|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.006|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.006
73940293|NCT02130193|147412881|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.003|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.003
73940294|NCT02130193|147412881|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.001|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.001
73940295|NCT02130193|147412881|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977|<|0.001|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|<0.001
73973972|NCT02933489|147491532|EQUIVALENCE|Specificity DBT = Specificity AB-MR|||||<|0.001||||||The comparison of the Specificity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance|McNemar|||||||<0.001
73940296|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|1.29||0.6|TWO_SIDED|95.0|-2.81|2.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 1 month. Data presented are for 95% equal-tailed credible intervals|||2.17|-2.81|0.60
73940297|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.58|STANDARD_DEVIATION|1.42||0.65|TWO_SIDED|95.0|-3.11|2.37||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 2 month. Data presented are for 95% equal-tailed credible intervals|||2.37|-3.11|0.65
73940298|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.46|STANDARD_DEVIATION|1.52||0.83|TWO_SIDED|95.0|-4.43|1.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 3 month. Data presented are for 95% equal-tailed credible intervals|||1.45|-4.43|0.83
73973973|NCT03982186|147491556|SUPERIORITY||Difference of proportions|-2.3|||=|0.848|TWO_SIDED|90.0|-5.97|1.38|||Mantel Haenszel|||||1.38|-5.97|= 0.848
73973974|NCT03982186|147491556|SUPERIORITY||Difference of proportions|7.4|||=|0.027|TWO_SIDED|90.0|1.07|13.68|||Mantel Haenszel|||||13.68|1.07|= 0.027
73973975|NCT03982186|147491556|SUPERIORITY||Difference of proportions|9.1|||=|0.917|TWO_SIDED|90.0|4.16|14.07|||Mantel Haenszel|||||14.07|4.16|= 0.917
73973976|NCT03982186|147491556|SUPERIORITY||Difference of proportions|-6.7|||=|0.917|TWO_SIDED|90.0|-14.67|1.25|||Mantel Haenszel|||||1.25|-14.67|= 0.917
73973977|NCT03952520|147491617|SUPERIORITY||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|26.5|48.1|||||This generalized linear model was adjusted for engagement of site leadership. The Standard Approach is the referent.|||48.1|26.5|
73973978|NCT03952520|147491618|SUPERIORITY||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|2.0|2.1|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||2.1|2.0|
73973979|NCT03952520|147491620|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||0.4|-0.2|
73973980|NCT03952520|147491621|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.1|2.0|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||2.0|-3.1|
73973981|NCT03952520|147491622|SUPERIORITY||Prevalence Difference|15.8|||||TWO_SIDED|95.0|5.0|26.5|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||26.5|5.0|
74089045|NCT04146363|147731362|SUPERIORITY||LS Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.121||0.455291|TWO_SIDED|95.0|-0.33|0.15|||ANCOVA|||||0.15|-0.33|0.455291
73940299|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.2|STANDARD_DEVIATION|1.53||0.78|TWO_SIDED|95.0|-4.07|1.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 4 month. Data presented are for 95% equal-tailed credible intervals|||1.90|-4.07|0.78
73940300|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.96|STANDARD_DEVIATION|1.56||0.73|TWO_SIDED|95.0|-3.82|2.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 5 month. Data presented are for 95% equal-tailed credible intervals|||2.28|-3.82|0.73
73940301|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.93|STANDARD_DEVIATION|1.58||0.72|TWO_SIDED|95.0|-4.01|2.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 6 month. Data presented are for 95% equal-tailed credible intervals|||2.26|-4.01|0.72
73973982|NCT03952520|147491623|SUPERIORITY||Prevalence Difference|1.6|||||TWO_SIDED|95.0|-6.9|10.0|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||10.0|-6.9|
73973983|NCT03952520|147491625|SUPERIORITY||Prevalence Difference|6.2|||||TWO_SIDED|95.0|-1.5|13.8|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||13.8|-1.5|
73973984|NCT03635567|147491627|OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.47|0.71||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (hazard ratio \[HR\]) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.71|0.47|<0.0001
73973985|NCT03635567|147491628|OTHER||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.5|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.50|<0.0001
73973986|NCT03635567|147491629|OTHER||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.68|0.40|<0.0001
73973987|NCT03635567|147491630|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.49|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.49|<0.0001
73973988|NCT03635567|147491631|OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.52|0.77||No formal hypothesis testing performed; nominal p-value based on log-rank test provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.77|0.52|<0.0001
73973989|NCT03635567|147491632|OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.78||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.78|0.44|<0.0001
73973990|NCT03635567|147491633|OTHER||Difference in Percentage|14.9||||0.0001|TWO_SIDED|95.0|7.4|22.3||No formal hypothesis testing performed; nominal p-value provided for treatment comparison|Miettinen & Nurminen method|||Treatment comparison was based on Miettinen \& Nurminen method stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||22.3|7.4|0.0001
73973991|NCT03635567|147491636|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.49|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.49|<0.0001
73973992|NCT01880515|147491643|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.17|0.99||||||||0.99|0.17|
73867184|NCT01793883|147279766|SUPERIORITY|||||||0.818|||||||Log Rank|||||||0.818
73940302|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.0|STANDARD_DEVIATION|1.58||0.73|TWO_SIDED|95.0|-4.15|2.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.09|-4.15|0.73
73940303|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.48|STANDARD_DEVIATION|1.69||0.81|TWO_SIDED|95.0|-4.71|1.76||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.76|-4.71|0.81
73940304|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.23|STANDARD_DEVIATION|1.75||0.76|TWO_SIDED|95.0|-4.66|2.22||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 9 month. Data presented are for 95% equal-tailed credible intervals|||2.22|-4.66|0.76
73940305|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.26|STANDARD_DEVIATION|1.74||0.91|TWO_SIDED|95.0|-5.66|0.99||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.99|-5.66|0.91
73940306|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.05|STANDARD_DEVIATION|1.73||0.71|TWO_SIDED|95.0|-4.73|2.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 11 month. Data presented are for 95% equal-tailed credible intervals|||2.13|-4.73|0.71
73940307|NCT02130193|147412882|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.35|STANDARD_DEVIATION|1.74||0.78|TWO_SIDED|95.0|-4.77|2.04||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 12 month. Data presented are for 95% equal-tailed credible intervals|||2.04|-4.77|0.78
73940308|NCT02130193|147412886|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.278|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.278
73973993|NCT01880515|147491646|SUPERIORITY|||||||0.41|||||||Log Rank|||||||0.41
73940309|NCT02130193|147412886|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.138|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.138
73940310|NCT02130193|147412886|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.05|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.05
73940311|NCT02130193|147412886|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.011|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.011
73973994|NCT04243759|147491647|SUPERIORITY|||||||0.97|||||||ANOVA|||||||0.97
73973995|NCT04243759|147491648|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_DEVIATION|2.09||0.232|TWO_SIDED|95.0|-0.24|0.95|||t-test, 2 sided|||Within subjects comparison of drinks per drinking day with full intervention app access versus daily assessment via the app only||0.95|-0.24|.232
73940312|NCT02130193|147412886|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.002|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.002
73940313|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.62|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.62
73940314|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.64|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.64
73973996|NCT02777593|147491696|OTHER|Performance goal tested using Exact method calculation to estimate the 95% one-sided lower confidence level (95% LCL) on the proportion of participants with primary endpoint success. If the 95% LCL exceeded 0.64, then the the null hypothesis was to be rejected and the PG was met.|95% Exact Lower Confidence Limit|0.751|||||ONE_SIDED|||||||||"Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 12-Month imaging performed.~Results were tested against a performance goal (PG) of 0.64 (i.e. 64%), derived from historical GORE TAG® and Conformable TAG® data.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 70 patients. With attrition, 85 patients were required."||||
73973997|NCT03351998|147491698|SUPERIORITY||Mean Difference (Net)|36.02|STANDARD_DEVIATION|365.55||0.6051|TWO_SIDED||||||signed rank test|This is within group 12 month change.||||||0.6051
73867185|NCT02478255|147279767|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
73867186|NCT00061633|147279774|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 39% power to test televancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 10%.||||||0.5289|||||||2-sided 95% confidence interval|||95% Confidence Interval: -0.1349 to 0.0485 No est. value. Parameter that was estimated: Risk Difference||||0.5289
73867187|NCT03100058|147279811|OTHER|Dose finding study|Mean Difference (Net)|-1.73|||<|0.0001|TWO_SIDED|95.0|-3.17|-0.29|||ANCOVA|||||-0.29|-3.17|<0.0001
74089046|NCT04146363|147731363|SUPERIORITY||LS Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|1.52||6.9e-05|TWO_SIDED|95.0|-10.1|-3.9|||Mixed Models Analysis|||||-3.9|-10.1|0.000069
73940315|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.81|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.81
73940316|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.77|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.77
73940317|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.71|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.71
73940318|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.7|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.70
73940319|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.74|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.74
73940320|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.79|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.79
73867188|NCT03100058|147279811|OTHER|Dose finding study|Median Difference (Net)|-1.93|||<|0.0001|TWO_SIDED|95.0|-3.36|-0.5|||ANCOVA|||||-0.50|-3.36|<0.0001
73940321|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.77|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.77
73940322|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.9|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.90
73940323|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.66|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.66
73940324|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.74|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.74
73940325|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.43|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.43
73973998|NCT03351998|147491698|SUPERIORITY||Mean Difference (Net)|31.89|STANDARD_DEVIATION|213.0||0.9434|TWO_SIDED||||||signed rank test|This is within group 12 month change.||||||0.9434
73973999|NCT03351998|147491698|SUPERIORITY||Mean Difference (Net)|-3.39|STANDARD_DEVIATION|179.54||0.9408|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.9408
73974000|NCT03351998|147491699|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.23||0.7458|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.7458
73974001|NCT03351998|147491699|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|0.16||0.4056|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.4056
73974002|NCT03351998|147491699|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|0.18||0.1932|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.1932
73974003|NCT01527188|147491736|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-198.18||||0.0427|TWO_SIDED|95.0|-389.82|-6.55|||ANCOVA|||||-6.55|-389.82|0.0427
73974004|NCT01527188|147491736|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-171.82||||0.0793||95.0|-363.87|20.24|||ANCOVA|||||20.24|-363.87|0.0793
73974005|NCT01527188|147491736|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-118.43|||||TWO_SIDED|95.0|-305.9|69.04|||ANCOVA|||The statistical test is not applicable due to the step-down approach performed to address the multiplicity issue.||69.04|-305.90|
73974006|NCT01527188|147491737|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-125.61||||0.0323||95.0|-240.53|-10.69|||ANCOVA|||||-10.69|-240.53|0.0323
73974007|NCT01527188|147491737|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-122.23||||0.0376||95.0|-237.38|-7.08|||ANCOVA|||||-7.08|-237.38|0.0376
74089047|NCT02914236|147731365|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Hypothesis was that the mean improvement in NOSE score exceeded 15 points||||||<0.0001
73867189|NCT03100058|147279811|OTHER|Dose finding study|Mean Difference (Net)|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.86|-1.75|||ANCOVA|||||-1.75|-4.86|<0.0001
73867190|NCT03100058|147279811|OTHER|Dose finding study|Mean Difference (Net)|-4.42|||<|0.0001|TWO_SIDED|95.0|-5.39|-3.44|||ANCOVA|||||-3.44|-5.39|<0.0001
73867191|NCT03100058|147279811|OTHER|Dose finding study|Mean Difference (Net)|-1.14|||<|0.0001|TWO_SIDED|95.0|-2.53|-0.25|||ANCOVA|||||-0.25|-2.53|<0.0001
73940326|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.45|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.45
73940327|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.67|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.67
73940328|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.62|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.62
73940329|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.55|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.55
73940330|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.55|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.55
73940331|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.59|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.59
73940332|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.65|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.65
73940333|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.63|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.63
73940334|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.81|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.81
73940335|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.52|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.52
73940336|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.6|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.60
73940337|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.24|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.24
73940338|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.28|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.28
73940339|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.5|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.50
73940340|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.43|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.43
73974008|NCT01527188|147491737|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-91.18||||0.1119||95.0|-203.74|21.38|||ANCOVA|||||21.38|-203.74|0.1119
73867192|NCT03100058|147279811|OTHER|Dose finding study|Mean Difference (Net)|-2.74|||<|0.0001|TWO_SIDED|95.0|-4.11|-1.36|||ANCOVA|||||-1.36|-4.11|<0.0001
73867193|NCT03100058|147279811|OTHER|Dose finding study|Mean Difference (Net)|-4.11|||<|0.0001|TWO_SIDED|95.0|-5.54|-2.68|||ANCOVA|||||-2.68|-5.54|<0.0001
73867194|NCT03100058|147279811|OTHER|Dose finding study|Mean Difference (Net)|-4.48|||<|0.0001|TWO_SIDED|95.0|-5.54|-3.43|||ANCOVA|||||-3.43|-5.54|<0.0001
73940341|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.37|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.37
74031081|NCT00570739|147615661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.5267|TWO_SIDED|95.0|-19.72|10.13||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||10.13|-19.72|0.5267
74031082|NCT00570739|147615662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.5882|TWO_SIDED|95.0|0.4|1.83||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||1.83|0.40|0.5882
74089048|NCT02914236|147731366|SUPERIORITY||||||<|0.0001|||||||binomial test|Success threshold required at least 55% of subjects to be responders||||||<0.0001
73940342|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.38|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.38
73940343|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.43|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.43
73940344|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.51|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.51
73940345|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.5|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.50
73940346|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.7|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.70
73940347|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.38|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.38
73940348|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.45|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.45
73940349|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.11|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.11
73940350|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.15|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.15
73940351|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.32|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.32
74031083|NCT00570739|147615662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.7098|TWO_SIDED|95.0|0.44|1.96||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||1.96|0.44|0.7098
74031084|NCT00570739|147615662|SUPERIORITY_OR_OTHER|||||||0.6835||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.6835
74031085|NCT00570739|147615662|SUPERIORITY_OR_OTHER|||||||0.8461||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.8461
74089049|NCT00836719|147731373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||<|0.01||95.0|3.4|16.2|||Mixed Models Analysis|Anisotropic power spatial covariance matrix with terms for time and the registered voxel. Kenward Rogers approx. for degrees of freedom.|Dependent variable: NAA. Main effect: visit. Covariates Cre, %GM, %WM, %CSF and %lesion in the voxel.|N-Acetylaspartate acid (NAA) levels were measured at baseline and exit (6 months). Voxels with less than 30% error in NAA and Creatine (Cre) were used.NAA, Cre and Proton Density were log transformed.||16.2|3.4|<0.01
74089050|NCT02678442|147731378|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
74089051|NCT02678442|147731380|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73940352|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.28|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.28
73940353|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.23|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.23
73940354|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.24|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.24
73940355|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.29|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.29
74031086|NCT00570739|147615663|SUPERIORITY_OR_OTHER|||||||0.2079||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks||||0.2079
73867195|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|2.38||||0.099|TWO_SIDED|95.0|0.85|6.67|||ANCOVA|||\>=5%||6.67|0.85|0.099
73940356|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.36|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.36
73940357|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.35|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.35
73940358|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.57|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.57
73940359|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.25|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.25
73940360|NCT02130193|147412887|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.32|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.32
73940361|NCT02130193|147412888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.477|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 1.0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.477
73940362|NCT02130193|147412888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.343|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.9 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.343
73940363|NCT02130193|147412888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.221|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.8 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.221
73940364|NCT02130193|147412888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.116|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.116
73940365|NCT02130193|147412888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.052|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.6 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.052
73940366|NCT02130193|147412889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.212|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.212
73940367|NCT02130193|147412889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.111|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.111
73940368|NCT02130193|147412889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.049|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.049
73940369|NCT02130193|147412889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.012|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.012
74031087|NCT00570739|147615663|SUPERIORITY_OR_OTHER|||||||0.4053||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.4053
73940370|NCT02130193|147412889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.001|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.001
73940371|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.64|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.64
73940372|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.75|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.75
73940373|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.77|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.77
73940374|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.74|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.74
73940375|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.67|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.67
73940376|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.69|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.69
73940377|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.72|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.72
73974009|NCT04933474|147491777|OTHER|||||||0.088|||||||Chi-squared|||The primary outcome will be the baseline vs. week 8 difference-in-difference in 7-day average NRS pain intensity scores, dichotomized into if the MCID of 2 is achieved. The between arm difference of achieving the MCID of 2 will be tested using Chi-squared test.||||0.088
73974010|NCT04933474|147491778|OTHER|||||||0.103|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.103
73974011|NCT04933474|147491779|OTHER|||||||0.774|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.774
73940378|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.71|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.71
73940379|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.66|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.66
73940380|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.84|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.84
73940381|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.65|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.65
73940382|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.71|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.71
73974012|NCT04933474|147491780|OTHER|||||||0.005|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.005
73974013|NCT04933474|147491781|OTHER|||||||0.831|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.831
74031088|NCT00570739|147615663|SUPERIORITY_OR_OTHER|||||||0.5752||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks||||0.5752
73940383|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.13|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.13
73940384|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.27|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.27
73940385|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.31|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.31
73940386|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.29|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.29
73940387|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.23|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.23
73940388|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.26|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.26
73940389|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.28|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.28
73940390|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.29|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.29
73940391|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.23|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.23
73940392|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.45|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.45
73940393|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.24|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.24
73940394|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.28|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.28
73940395|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.26|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.26
73940396|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.41|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.41
73940397|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.46|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.46
73940398|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.43|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.43
74031089|NCT00570739|147615663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7994|TWO_SIDED|95.0|0.25|2.29||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||2.29|0.25|0.7994
74089052|NCT02678442|147731381|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
74089053|NCT02678442|147731382|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||.001
74089054|NCT01117337|147731422|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
74089055|NCT01117337|147731423|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Fisher Exact|||||||0.56
73867196|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio, log|1.18||||0.779|TWO_SIDED|95.0|0.36|3.84|||ANCOVA|||\>=5%||3.84|0.36|0.779
73940399|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.36|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.36
73974014|NCT04933474|147491782|OTHER||Common Odds Ratio|1.44||||0.031|TWO_SIDED|95.0|1.03|2.02||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and week 8) and opioid use (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||2.02|1.03|0.031
73974015|NCT03816397|147491837|SUPERIORITY|A sample size of 118 subjects (59 in each group) provides 88% power to detect a hazard ratio of 2.0 for the time to treatment failure comparing the group randomized to discontinue adalimumab to the group randomized to continue using adalimumab, assuming a median time until treatment failure of 10 weeks in the group that discontinues adalimumab (Arm 1) and of 20 weeks in the group that continues on adalimumab (Arm 2), an equal allocation between groups, and a 10% total loss to follow-up.|Hazard Ratio (HR)|8.7|||<|0.0001|TWO_SIDED|95.0|3.6|21.2||A priori threshold for statistical significance was \<0.05.|Log Rank||For the HR, the numerator is the placebo group (stop adalimumab) and the denominator is the adalimumab group (continue adalimumab).|A Cox proportional hazards regression was used to compare time to treatment failure between the adalimumab and placebo groups up to the primary endpoint of 48 weeks, with country and conventional DMARD use included as fixed effects in the model. The null hypothesis was an hazard ratio (HR) of 1. Hypothesis testing was based on a permutation test of the log hazard ratio (100,000 replicates). The model was checked for the assumption of proportional hazards by assessing Schoenfeld residuals.||21.2|3.6|<0.0001
73974016|NCT05485935|147491838|SUPERIORITY||Mean Difference (Final Values)|45.94||||0.001|TWO_SIDED|95.0|19.24|72.64||The pass criteria were based on results analysing the 2 primary endpoints in a hierarchical fashion: rejecting the H0 on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||72.64|19.24|0.001
73974017|NCT05485935|147491839|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.15|||<|0.001|TWO_SIDED|95.0|0.07|0.35|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.35|0.07|<0.001
73974018|NCT05485935|147491840|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.13|||<|0.001|TWO_SIDED|95.0|0.04|0.4|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.40|0.04|<0.001
73974019|NCT05485935|147491841|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mean Difference (Final Values)|28.5||||0.004|TWO_SIDED|95.0|9.5|47.6|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||47.6|9.5|0.004
73974020|NCT03839446|147491851|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.777|TWO_SIDED|95.0|0.18|3.65|||Regression, Cox||Intermediate / Favorable vs Poor|Cytogenetic status||3.65|0.18|0.777
73974021|NCT03839446|147491851|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.2|TWO_SIDED|95.0|0.96|1.01|||Regression, Cox|||Percent of blasts present in the bone marrow.||1.01|0.96|0.200
73974022|NCT03839446|147491851|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.014|TWO_SIDED|95.0|0.94|0.99|||Regression, Cox|||% CD33 expression in leukemia blasts||0.99|0.94|0.014
73974023|NCT03839446|147491852|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.801|TWO_SIDED|95.0|0.17|3.86|||Regression, Cox||Intermediate / Favorable vs Poor|Cytogenetic status||3.86|0.17|0.801
73974024|NCT03839446|147491852|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.168|TWO_SIDED|95.0|0.95|1.01|||Regression, Cox|||% bone marrow blasts||1.01|0.95|0.168
73974025|NCT03839446|147491852|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.015|TWO_SIDED|95.0|0.94|0.99|||Regression, Cox|||% CD33 expression in leukemia blasts||0.99|0.94|0.015
73867197|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|3.69||||0.011|TWO_SIDED|95.0|1.35|10.11|||ANCOVA|||\>=5%||10.11|1.35|0.011
73940400|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.39|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.39
74008409|NCT03627767|147566508|SUPERIORITY||LSM difference|-0.8|||=|0.002|TWO_SIDED|95.0|-1.2|-0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.2|= 0.0020
73867198|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|5.57|||<|0.001|TWO_SIDED|95.0|2.41|12.88|||ANCOVA|||\>=5%||12.88|2.41|<.001
73867199|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|1.15||||0.812|TWO_SIDED|95.0|0.36|3.74|||ANCOVA|||\>=5%||3.74|0.36|0.812
73867200|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|1.94||||0.229|TWO_SIDED|95.0|0.66|5.69|||ANCOVA|||\>=5%||5.69|0.66|0.229
73867201|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|4.29||||0.004|TWO_SIDED|95.0|1.61|11.46|||ANCOVA|||\>=5%||11.46|1.61|0.004
73867202|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|6.37|||<|0.001|TWO_SIDED|95.0|2.72|14.93|||ANCOVA|||\>=5%||14.93|2.72|<.001
73867203|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|1.09||||0.943|TWO_SIDED|95.0|0.1|12.41|||ANCOVA|||\>=10%||12.41|0.10|0.943
73867204|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|2.11||||0.465|TWO_SIDED|95.0|0.28|15.77|||ANCOVA|||\>=10%||15.77|0.28|0.465
73867205|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|1.6||||0.696|TWO_SIDED|95.0|0.15|17.15|||ANCOVA|||\>=10%||17.15|0.15|0.696
73867206|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|2.14||||0.389|TWO_SIDED|95.0|0.38|12.1|||ANCOVA|||\>=10%||12.10|0.38|0.389
73867207|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|1.04||||0.976|TWO_SIDED|95.0|0.09|11.87|||ANCOVA|||\>=10%||11.87|0.09|0.976
73867208|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|1.02||||0.986|TWO_SIDED|95.0|0.09|11.7|||ANCOVA|||\>=10%||11.70|0.09|0.986
73867209|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|3.51||||0.181|TWO_SIDED|95.0|0.56|22.18|||ANCOVA|||\>=10%||22.18|0.56|0.181
73867210|NCT03100058|147279812|OTHER|Dose finding study|Odds Ratio (OR)|3.97||||0.1|TWO_SIDED|95.0|0.77|20.54|||ANCOVA|||\>=10%||20.54|0.77|0.100
73940401|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.42|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.42
73940402|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.42|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.42
73867211|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|6.29||||0.048|TWO_SIDED|95.0|1.02|38.76|||ANCOVA|||\>=5% (Dysglycemic)||38.76|1.02|0.048
73867212|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio, log|3.94||||0.171|TWO_SIDED|95.0|0.55|28.03|||ANCOVA|||\>=5% (Dsyglycemic)||28.03|0.55|0.171
73867213|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|7.17||||0.041|TWO_SIDED|95.0|1.09|47.27|||ANCOVA|||\>=5% (Dysglycemic)||47.27|1.09|0.041
73867214|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|11.89||||0.003|TWO_SIDED|95.0|2.32|60.93|||ANCOVA|||\>=5% (Dysglycemic)||60.93|2.32|0.003
73867215|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|0.96||||0.976|TWO_SIDED|95.0|0.08|11.72|||ANCOVA|||\>=5% (Dysglycemic)||11.72|0.08|0.976
73940403|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.35|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.35
73940404|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.58|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.58
73867216|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|8.78||||0.022|TWO_SIDED|95.0|1.37|56.44|||ANCOVA|||\>=5% (Dysglycemic)||56.44|1.37|0.022
73867217|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|7.5||||0.032|TWO_SIDED|95.0|1.2|46.99|||ANCOVA|||\>=5% (Dysglycemic)||46.99|1.20|0.032
73867218|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|11.28||||0.005|TWO_SIDED|95.0|2.11|60.46|||ANCOVA|||\>=5% (Dysglycemic)||60.46|2.11|0.005
73867219|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|3.21||||0.227|TWO_SIDED|95.0|0.48|21.28|||ANCOVA|||\>=5% (Normoglycemic)||21.28|0.48|0.227
73867220|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|0.69||||0.763|TWO_SIDED|95.0|0.06|7.85|||ANCOVA|||\>=5% (Normoglycemic)||7.85|0.06|0.763
73867221|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|4.68||||0.095|TWO_SIDED|95.0|0.76|28.7|||ANCOVA|||\>=5% (Normoglycemic)||28.70|0.76|0.095
73867222|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|5.33||||0.033|TWO_SIDED|95.0|1.14|24.83|||ANCOVA|||\>=5% (Normoglycemic)||24.83|1.14|0.033
73867223|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|0.72||||0.788|TWO_SIDED|95.0|0.06|8.1|||ANCOVA|||\>=5% (Normoglycemic)||8.10|0.06|0.788
73867224|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|0.68||||0.751|TWO_SIDED|95.0|0.06|7.62|||ANCOVA|||\>=5% (Normoglycemic)||7.62|0.06|0.751
73867225|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|8.05||||0.027|TWO_SIDED|95.0|1.27|51.09|||ANCOVA|||\>=5% (Normoglycemic)||51.09|1.27|0.027
73867226|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|6.64||||0.023|TWO_SIDED|95.0|1.3|34.0|||ANCOVA|||\>=5% (Normoglycemic)||34.00|1.30|0.023
73867227|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|0.48||||0.528|TWO_SIDED|95.0|0.05|4.78|||ANCOVA|||\>=5% (T2DM)||4.78|0.05|0.528
73867228|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|1.05||||0.958|TWO_SIDED|95.0|0.17|6.68|||ANCOVA|||\>=5% (T2DM)||6.68|0.17|0.958
73867229|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|1.7||||0.546|TWO_SIDED|95.0|0.3|9.49|||ANCOVA|||\>=5% (T2DM)||9.49|0.30|0.546
73867230|NCT03100058|147279813|OTHER|Dose finding test|Odds Ratio (OR)|3.09||||0.098|TWO_SIDED|95.0|0.81|11.75|||ANCOVA|||\>=5% (T2DM)||11.75|0.81|0.098
73867231|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|1.64||||0.563|TWO_SIDED|95.0|0.31|8.7|||ANCOVA|||\>=5% (T2DM)||8.70|0.31|0.563
73940405|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.36|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.36
73940406|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.41|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.41
73940407|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.66|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.66
73940408|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.66|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.66
73940409|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.91|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.91
73940410|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.79|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.79
73940411|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.84|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.84
73940412|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.81|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.81
73867232|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|0.55||||0.61|TWO_SIDED|95.0|0.06|5.38|||ANCOVA|||\>=5% (T2DM)||5.38|0.06|0.610
73940413|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.76|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.76
73940414|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.84|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.84
73940415|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.83|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.83
73940416|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.94|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.94
73940417|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.84|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.84
73940418|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.81|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.81
73940419|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.01|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.01
73940420|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.02|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.02
73867233|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|1.71||||0.528|TWO_SIDED|95.0|0.32|9.16|||ANCOVA|||\>=5% (T2DM)||9.16|0.32|0.528
73867234|NCT03100058|147279813|OTHER|Dose finding study|Odds Ratio (OR)|4.55||||0.023|TWO_SIDED|95.0|1.23|16.9|||ANCOVA|||\>=5% (T2DM)||16.90|1.23|0.023
73867235|NCT03100058|147279814|OTHER|Dose finding study|Median Difference (Net)|-0.8||||0.47|TWO_SIDED|95.0|-2.96|1.37|||ANCOVA|||||1.37|-2.96|0.470
73867236|NCT03100058|147279814|OTHER|Dose finding study|Median Difference (Net)|-1.4||||0.199|TWO_SIDED|95.0|-3.64|0.76|||ANCOVA|||||0.76|-3.64|0.199
73940421|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.15|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.15
73940422|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.05|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.05
73940423|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.08|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.08
73940424|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.08|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.08
73940425|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.06|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.06
73940426|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.14|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.14
73940427|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.14|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.14
73940428|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.29|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.29
73940429|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.15|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.15
73940430|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.13|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.13
73940431|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.06|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.06
74031090|NCT00570739|147615663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.996|TWO_SIDED|95.0|0.32|3.03||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||3.03|0.32|0.9960
74031091|NCT00570739|147615663|SUPERIORITY_OR_OTHER|||||||0.7783||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.7783
74031092|NCT00570739|147615663|SUPERIORITY_OR_OTHER|||||||0.9774||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.9774
74031093|NCT00570739|147615664|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks||||<0.0001
74031094|NCT00570739|147615664|SUPERIORITY_OR_OTHER|||||||0.4058||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.4058
74031095|NCT00570739|147615664|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks||||0.0254
74031096|NCT00570739|147615664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1499|TWO_SIDED|95.0|0.74|3.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||3.55|0.74|0.1499
74031097|NCT00570739|147615664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.042|TWO_SIDED|95.0|0.97|4.45||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||4.45|0.97|0.0420
74031098|NCT00570739|147615664|SUPERIORITY_OR_OTHER|||||||0.224||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2240
74031099|NCT00570739|147615664|SUPERIORITY_OR_OTHER|||||||0.0593||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.0593
73940432|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.09|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.09
73940433|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.37|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.37
73940434|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.18|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.18
73940435|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.24|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.24
73940436|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.24|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.24
73940437|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.19|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.19
73940438|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.32|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.32
73940439|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.32|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.32
73940440|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.52|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.52
73940441|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.33|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.33
73940442|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.29|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.29
73940443|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.31||0.43|TWO_SIDED|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.59|0.43
73940444|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.19|STANDARD_DEVIATION|0.35||0.29|TWO_SIDED|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.85|-0.53|0.29
73940445|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.2|STANDARD_DEVIATION|0.38||0.7|TWO_SIDED|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.94|0.70
73940446|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.21|STANDARD_DEVIATION|0.37||0.71|TWO_SIDED|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.50|-0.92|0.71
73940447|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.11|STANDARD_DEVIATION|0.37||0.61|TWO_SIDED|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.61|-0.82|0.61
73940448|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.02|STANDARD_DEVIATION|0.36||0.48|TWO_SIDED|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.69|0.48
74008410|NCT03627767|147566508|SUPERIORITY||LSM difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.2|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.2|-2.2|< 0.0001
74089056|NCT03575871|147731424|SUPERIORITY||Difference in Percentage|19.3||||0.0008|TWO_SIDED|95.0|9.6|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.0|9.6|0.0008
74089057|NCT03575871|147731424|SUPERIORITY||Difference in Percentage|28.7|||<|0.0001|TWO_SIDED|95.0|18.6|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.8|18.6|<0.0001
73867237|NCT03100058|147279814|OTHER|Dose finding study|Median Difference (Net)|-1.4|||<|0.001|TWO_SIDED|95.0|-3.64|0.76|||ANCOVA|||||0.76|-3.64|<0.001
73867238|NCT03100058|147279814|OTHER|Dose finding study|Mean Difference (Net)|-1.4||||0.206|TWO_SIDED|95.0|-3.56|0.77|||ANCOVA|||||0.77|-3.56|0.206
74031100|NCT00570739|147615665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.4794|TWO_SIDED|95.0|0.31|1.4||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||1.40|0.31|0.4794
74031101|NCT00570739|147615665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.6667|TWO_SIDED|95.0|0.37|1.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||1.55|0.37|0.6667
74031102|NCT00570739|147615665|SUPERIORITY_OR_OTHER|||||||0.2768||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2768
74031103|NCT00570739|147615665|SUPERIORITY_OR_OTHER|||||||0.4395||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.4395
74031104|NCT00570739|147615666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.1375|TWO_SIDED|95.0|0.89|6.64||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||6.64|0.89|0.1375
73867239|NCT03100058|147279814|OTHER|Dose finding study|Median Difference (Net)|-3.0||||0.006|TWO_SIDED|95.0|-5.18|-0.88|||ANCOVA|||||-0.88|-5.18|0.006
73867240|NCT03100058|147279814|OTHER|Dose finding study|Median Difference (Net)|-3.5||||0.002|TWO_SIDED|95.0|-5.7|-1.3|||ANCOVA|||||-1.30|-5.70|0.002
73867241|NCT03100058|147279814|OTHER|Dose finding study|Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|95.0|-5.1|-1.51|||ANCOVA|||||-1.51|-5.10|<0.001
74031105|NCT00570739|147615666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.1996|TWO_SIDED|95.0|0.85|5.82|||Cochran-Mantel-Haenszel|P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.||Baseline to 16 Weeks LOCF||5.82|0.85|0.1996
74031106|NCT00570739|147615666|SUPERIORITY_OR_OTHER|||||||0.0829||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.0829
74031107|NCT00570739|147615666|SUPERIORITY_OR_OTHER|||||||0.1037||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.1037
74031108|NCT00325442|147615668|SUPERIORITY_OR_OTHER||Hodges-Lehmann|11.0||||0.072|TWO_SIDED|95.0|0.0|22.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||22|0|0.072
74031109|NCT00325442|147615669|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.062|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Change in Borg dyspnea score from Baseline to Week 16||0.0|-1.0|0.062
74031110|NCT00325442|147615670|SUPERIORITY_OR_OTHER|||||||0.491||95.0|||||Fisher Exact|||||||0.491
74031111|NCT00325442|147615671|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.011|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon sum-rank test|||Change in dyspnea-fatigue index from Baseline to Week 16||1.0|0.0|0.011
74031112|NCT00325442|147615673|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|13.0||||0.015|TWO_SIDED|95.0|3.0|23.0|||ANCOVA|||Change in 6MWD from Baseline to Week 12||23.0|3.0|0.015
74031113|NCT00325442|147615674|SUPERIORITY_OR_OTHER||Hodges-Lehmann|9.0||||0.051|TWO_SIDED|95.0|0.0|18.0|||ANCOVA|||Change in 6MWD from Baseline to Week 8||18.0|0.0|0.051
74089058|NCT03575871|147731425|SUPERIORITY||Difference in Percentage|33.9|||<|0.0001|TWO_SIDED|95.0|23.3|44.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.4|23.3|<0.0001
73867242|NCT03100058|147279814|OTHER|Dose finding study|Median Difference (Net)|-0.9||||0.391|TWO_SIDED|95.0|-2.82|1.1|||ANCOVA|||||1.10|-2.82|0.391
74031114|NCT00325442|147615675|SUPERIORITY_OR_OTHER||Hodges-Lehmann ( H-L)|4.0||||0.238|TWO_SIDED|95.0|-2.4|12.0|||ANCOVA|||Change in 6MWD from Baseline to Week 4||12.0|-2.4|0.238
74031115|NCT00325442|147615676|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|24.0||||0.121|TWO_SIDED|95.0|0.0|45.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||45|0|0.121
73867243|NCT03100058|147279814|OTHER|Dose finding study|Median Difference (Net)|-2.5||||0.259|TWO_SIDED|95.0|-3.1|0.84|||ANCOVA|||||0.84|-3.10|0.259
73867244|NCT03100058|147279814|OTHER|Dose finding study|Mean Difference (Net)|-2.5||||0.048|TWO_SIDED|95.0|-4.91|-0.02|||ANCOVA|||||-0.02|-4.91|0.048
74031116|NCT00325442|147615677|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|15.0||||0.069|TWO_SIDED|95.0|-7.0|41.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||41|-7|0.069
74031117|NCT00325442|147615678|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|4.0||||0.889|TWO_SIDED|95.0|-15.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-15|0.889
74031118|NCT00325442|147615679|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.966|TWO_SIDED|95.0|-23.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-23|0.966
73867245|NCT03100058|147279815|OTHER|Dose finding study|Mean Difference (Net)|1.0||||0.225|TWO_SIDED|95.0|-0.62|2.61|||ANCOVA|||||2.61|-0.62|0.225
73867246|NCT03100058|147279815|OTHER|Dose finding study|Mean Difference (Net)|-1.0||||0.247|TWO_SIDED|95.0|-2.62|0.68|||ANCOVA|||||0.68|-2.62|0.247
73867247|NCT03100058|147279815|OTHER|Dose finding study|Median Difference (Net)|-2.0||||0.019|TWO_SIDED|95.0|-3.75|-0.34|||ANCOVA|||||-0.34|-3.75|0.019
73867248|NCT03100058|147279815|OTHER|Dose finding study|Mean Difference (Net)|-1.6||||0.015|TWO_SIDED|95.0|-2.96|-0.33|||ANCOVA|||||-0.33|-2.96|0.015
73867249|NCT03100058|147279815|OTHER|Dose finding study|Mean Difference (Net)|-1.3||||0.106|TWO_SIDED|95.0|-2.97|0.29|||ANCOVA|||||0.29|-2.97|0.106
73974026|NCT00709956|147491868|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-1.5||||0.7883|TWO_SIDED|95.0|-12.3|9.4||If the primary endpoint reaches significance, treatment effect of the secondary endpoint is determined at a 2-sided nominal of 0.05. Since hierarchy of the endpoints to be tested has been predefined, no correction for multiple testing will be applied|Generalized linear model|Subject (sequence), treatment, and period as fixed effect||With a sample size of at least 63 patients and based on the assumptions on the primary endpoint (normal distribution, SD of the difference of 30 m) the study was designed to detect a significant treatment effect with 90% power, assuming a difference exceeding 12.5 m between the mean values of the 6MWD following the iloprost power 15 treatment and the one following the placebo treatment.||9.4|-12.3|0.7883
73974027|NCT05157841|147491899|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL and bupivacaine HCI|Mean Difference (Final Values)|-164.0|STANDARD_ERROR_OF_MEAN|27.74|<|1e-05|TWO_SIDED|95.0|-218.3|-109.6|||ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||The superiority of EXPAREL to bupivacaine hydrochloric acid (HCI) was evaluated using the Efficacy Analysis Set.||-109.6|-218.3|<0.00001
73974028|NCT05157841|147491900|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL and bupivacaine HCI|Least square mean difference|0.39|||<|1e-05|TWO_SIDED|95.0|0.28|0.55|||ANCOVA|||The superiority of EXPAREL to bupivacaine hydrochloric acid (HCI) was evaluated using the Efficacy Analysis Set.||0.55|0.28|<0.00001
73974029|NCT05157841|147491901|SUPERIORITY||Odds Ratio (OR)|5.04||||0.0003|TWO_SIDED|95.0|2.01|12.62|||ANCOVA|||||12.62|2.01|0.0003
73974030|NCT05157841|147491902|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0089|TWO_SIDED|95.0|0.45|0.93|||Cox proportional hazards model|Cox proportional hazards model with treatment as main effect and site as categorical and age as continuous covariates.||||0.93|0.45|0.0089
73974031|NCT05157841|147491903|SUPERIORITY||Least square mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.44||0.0296|TWO_SIDED|95.0|-1.7|0.0||Worst pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariate of age.||||0.0|-1.7|0.0296
73974032|NCT05157841|147491903|SUPERIORITY||Least square mean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.4|<|1e-05|TWO_SIDED|95.0|-3.6|-2.1||Worst pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-2.1|-3.6|<0.00001
73974033|NCT05157841|147491903|SUPERIORITY||Least square mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.41|<|1e-05|TWO_SIDED|95.0|-4.1|-2.5||Worst pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-2.5|-4.1|<0.00001
73974034|NCT05157841|147491903|SUPERIORITY||Least square mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.43|<|1e-05|TWO_SIDED|95.0|-3.0|-1.3||Worst pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.3|-3.0|<0.00001
73974035|NCT05157841|147491903|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.3419|TWO_SIDED|95.0|-0.9|0.6||Average pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.6|-0.9|0.3419
73974036|NCT05157841|147491903|SUPERIORITY||Least square mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.5|-1.3||Average pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.3|-2.5|<0.00001
73974037|NCT05157841|147491903|SUPERIORITY||Least square mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.8|-1.6||Average pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.6|-2.8|<0.00001
73974038|NCT05157841|147491903|SUPERIORITY||Least square mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.1|-0.9||Average pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.9|-2.1|<0.00001
74031119|NCT00325442|147615681|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|5.0||||0.853|TWO_SIDED|95.0|-16.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||28|-16|0.853
73974039|NCT01992913|147492006|SUPERIORITY||||||<|0.05||||||"Fisher's exact Test, right-sided probability based on a directional hypothesis."|Fisher Exact|||We conducted a 2 X 2 chi-square analysis of differences in proportion.||||<.05
73974040|NCT01992913|147492006|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.06|TWO_SIDED|95.0|0.97|7.13|||Chi-squared|ChiSq = 3.6562, df = 1|OR, iCBT / TAU in job attainment|Chis Sq: group (iCBT/TAU) X Job attained (Yes/No)||7.13|0.97|<.06
73974041|NCT01992913|147492007|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|-0.9|STANDARD_ERROR_OF_MEAN|0.91|<|0.33|TWO_SIDED|95.0|-2.67|0.89|||Mixed Models Analysis|df (1, 30) for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 6 month assessment points.||.89|-2.67|<0.33
73867250|NCT03100058|147279815|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.02|TWO_SIDED|95.0|-3.54|-0.31|||ANCOVA|||||-0.31|-3.54|0.020
73867251|NCT03100058|147279815|OTHER|Dose finding study|Mean Difference (Net)|-1.8||||0.035|TWO_SIDED|95.0|-3.44|-0.12|||ANCOVA|||||-0.12|-3.44|0.035
73867252|NCT03100058|147279815|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.004|TWO_SIDED|95.0|-3.22|-0.61|||ANCOVA|||||-0.61|-3.22|0.004
73867253|NCT03100058|147279816|OTHER|Dose finding study|Mean Difference (Net)|0.4||||0.082|TWO_SIDED|95.0|-0.05|0.79|||ANCOVA|||||0.79|-0.05|0.082
73867254|NCT03100058|147279816|OTHER|Dose finding study|Median Difference (Net)|-0.2||||0.319|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||||0.21|-0.63|0.319
73974042|NCT01992913|147492007|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|0.52|STANDARD_ERROR_OF_MEAN|0.85|<|0.54|TWO_SIDED|95.0|-1.14|2.19|||Mixed Models Analysis|F (1, 130) = 1.0, p\<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 12 month assessment points.||2.19|-1.14|<.54
74031120|NCT00325442|147615682|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|7.0||||0.327|TWO_SIDED|95.0|-7.0|21.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||21|-7|0.327
73867255|NCT03100058|147279816|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.008|TWO_SIDED|95.0|-1.05|-0.16|||ANCOVA|||||-0.16|-1.05|0.008
73867256|NCT03100058|147279816|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.015|TWO_SIDED|95.0|-0.76|-0.08|||ANCOVA|||||-0.08|-0.76|0.015
73940449|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.08|STANDARD_DEVIATION|0.36||0.58|TWO_SIDED|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.79|0.58
73940450|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.4||0.83|TWO_SIDED|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.12|0.83
73940451|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.26|STANDARD_DEVIATION|0.41||0.74|TWO_SIDED|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-1.07|0.74
73940452|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.43||0.89|TWO_SIDED|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.29|-1.40|0.89
73940453|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.1|STANDARD_DEVIATION|0.41||0.59|TWO_SIDED|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.89|0.59
73974043|NCT01992913|147492007|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|0.83|<|0.71|TWO_SIDED|95.0|-1.32|1.73|||Mixed Models Analysis|F (1, 130) = 1.0, p\<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 18 month assessment point.||1.73|-1.32|<0.71
74031121|NCT00325442|147615683|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|29.5||||0.085|TWO_SIDED|95.0|1.0|73.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||73|1|0.085
73867257|NCT03100058|147279816|OTHER|Dose finding study|Mean Difference (Net)|-0.1||||0.707|TWO_SIDED|95.0|-0.5|0.34|||ANCOVA|||||0.34|-0.50|0.707
73867258|NCT03100058|147279816|OTHER|Dose finding study|Mean Difference (Net)|-0.2||||0.28|TWO_SIDED|95.0|-0.65|0.19|||ANCOVA|||||0.19|-0.65|0.280
73867259|NCT03100058|147279816|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.086|TWO_SIDED|95.0|-0.8|0.05|||ANCOVA|||||0.05|-0.80|0.086
73940454|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.3|STANDARD_DEVIATION|0.42||0.77|TWO_SIDED|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.54|-1.12|0.77
73940455|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.31||0.01|TWO_SIDED|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.59|0.01
73940456|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.19|STANDARD_DEVIATION|0.35||0.01|TWO_SIDED|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.85|-0.53|0.01
73940457|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.2|STANDARD_DEVIATION|0.38||0.09|TWO_SIDED|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.94|0.09
73940458|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.21|STANDARD_DEVIATION|0.37||0.09|TWO_SIDED|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.50|-0.92|0.09
73974044|NCT01992913|147492009|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the baseline assessment.|Mean Difference (Final Values)|-5.03|STANDARD_ERROR_OF_MEAN|3.82|<|0.19|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.19
73867260|NCT03100058|147279816|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.03|TWO_SIDED|95.0|-0.72|-0.04|||ANCOVA|||||-0.04|-0.72|0.030
73867261|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-2.8||||0.156|TWO_SIDED|95.0|-6.64|1.07|||ANCOVA|||SBP||1.07|-6.64|0.156
73867262|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-3.1||||0.127|TWO_SIDED|95.0|-7.11|0.89|||ANCOVA|||SBP||0.89|-7.11|0.127
73867263|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-6.5||||0.002|TWO_SIDED|95.0|-10.52|-2.42|||ANCOVA|||SBP||-2.42|-10.52|0.002
73867264|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-2.7||||0.089|TWO_SIDED|95.0|-5.86|0.42|||ANCOVA|||SBP||0.42|-5.86|0.089
73867265|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-2.3||||0.245|TWO_SIDED|95.0|-6.12|1.57|||ANCOVA|||SBP||1.57|-6.12|0.245
73867266|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-0.8||||0.678|TWO_SIDED|95.0|-4.65|3.02|||ANCOVA|||SBP||3.02|-4.65|0.678
73867267|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-4.1||||0.04|TWO_SIDED|95.0|-8.07|-0.19|||ANCOVA|||SBP||-0.19|-8.07|0.040
73867268|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-3.4||||0.038|TWO_SIDED|95.0|-6.61|-0.19|||ANCOVA|||SBP||-0.19|-6.61|0.038
73867269|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-0.7||||0.601|TWO_SIDED|95.0|-3.38|1.96|||ANCOVA|||DBP||1.96|-3.38|0.601
73867270|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.76|TWO_SIDED|95.0|-3.2|2.34|||ANCOVA|||DBP||2.34|-3.20|0.760
73867271|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-2.8||||0.051|TWO_SIDED|95.0|-5.6|0.01|||ANCOVA|||DBP||0.01|-5.60|0.051
73867272|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-1.8||||0.105|TWO_SIDED|95.0|-3.98|0.38|||ANCOVA|||DBP||0.38|-3.98|0.105
73940459|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.11|STANDARD_DEVIATION|0.37||0.05|TWO_SIDED|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.61|-0.82|0.05
73867273|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|0.3||||0.82|TWO_SIDED|95.0|-2.36|2.98|||ANCOVA|||DBP||2.98|-2.36|0.820
74031122|NCT00325442|147615684|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|5.0||||0.615|TWO_SIDED|95.0|-12.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-12|0.615
73867274|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.157|TWO_SIDED|95.0|-4.58|0.74|||ANCOVA|||DBP||0.74|-4.58|0.157
73940460|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|0.02|STANDARD_DEVIATION|0.36||0.02|TWO_SIDED|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.69|0.02
74031123|NCT00325442|147615685|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|17.0||||0.23|TWO_SIDED|95.0|-6.0|40.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||40|-6|0.230
74031124|NCT00325442|147615686|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|10.0||||0.209|TWO_SIDED|95.0|-6.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||28|-6|0.209
74031125|NCT01729598|147615689|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
73867275|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-0.2||||0.859|TWO_SIDED|95.0|-2.99|2.49|||ANCOVA|||DBP||2.49|-2.99|0.859
73867276|NCT03100058|147279817|OTHER|Dose finding study|Mean Difference (Net)|-2.2||||0.054|TWO_SIDED|95.0|-4.41|0.04|||ANCOVA|||DBP||0.04|-4.41|0.054
73867277|NCT03100058|147279819|OTHER|Dose finding study|Median Difference (Net)|-0.6||||0.355|TWO_SIDED|95.0|-1.84|0.66|||ANCOVA|||||0.66|-1.84|0.355
73867278|NCT03100058|147279819|OTHER|Dose finding study|Mean Difference (Net)|-0.6||||0.373|TWO_SIDED|95.0|-1.83|0.69|||ANCOVA|||||0.69|-1.83|0.373
73867279|NCT03100058|147279819|OTHER|Dose finding study|Mean Difference (Net)|-2.8|||<|0.001|TWO_SIDED|95.0|-4.36|-1.24|||ANCOVA|||||-1.24|-4.36|<0.001
73867280|NCT03100058|147279825|OTHER|Dose finding study|Mean Difference (Net)|1.07||||0.632|TWO_SIDED|95.0|0.81|1.42|||ANCOVA|||||1.42|0.81|0.632
73867281|NCT03100058|147279825|OTHER|Dose finding study|Mean Difference (Net)|1.15||||0.352|TWO_SIDED|95.0|0.86|1.55|||ANCOVA|||||1.55|0.86|0.352
73867282|NCT03100058|147279825|OTHER|Dose finding study|Mean Difference (Net)|1.41||||0.027|TWO_SIDED|95.0|1.04|1.92|||ANCOVA|||||1.92|1.04|0.027
73867283|NCT03100058|147279825|OTHER|Dose finding study|Mean Difference (Net)|1.07||||0.587|TWO_SIDED|95.0|0.85|1.35|||ANCOVA|||||1.35|0.85|0.587
73867284|NCT03100058|147279825|OTHER|Dose finding study|Mean Difference (Net)|1.1||||0.508|TWO_SIDED|95.0|0.82|1.47|||ANCOVA|||||1.47|0.82|0.508
73867285|NCT03100058|147279825|OTHER|Dose finding study|Mean Difference (Net)|1.01||||0.945|TWO_SIDED|95.0|0.76|1.34|||ANCOVA|||||1.34|0.76|0.945
73867286|NCT03100058|147279825|OTHER|Dose finding study|Mean Difference (Net)|1.08||||0.602|TWO_SIDED|95.0|0.81|1.45|||ANCOVA|||||1.45|0.81|0.602
73867287|NCT03100058|147279825|OTHER|Dose finding study|Mean Difference (Net)|1.06||||0.612|TWO_SIDED|95.0|0.84|1.35|||ANCOVA|||||1.35|0.84|0.612
73867288|NCT03100058|147279825|OTHER|Dose finding study|Median Difference (Net)|0.89||||0.382|TWO_SIDED|95.0|0.68|1.16|||ANCOVA|||||1.16|0.68|0.382
73867289|NCT03100058|147279825|OTHER|Dose finding study|Median Difference (Net)|0.87||||0.31|TWO_SIDED|95.0|0.67|1.14|||ANCOVA|||||1.14|0.67|0.310
73867290|NCT03100058|147279825|OTHER|Dose finding study|Mean Difference (Net)|0.9||||0.525|TWO_SIDED|95.0|0.65|1.25|||ANCOVA|||||1.25|0.65|0.525
73867291|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-7.9||||0.254|TWO_SIDED|95.0|-21.37|5.65|||ANCOVA|||Triglycerides (TG)||5.65|-21.37|0.254
73867292|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-2.7||||0.716|TWO_SIDED|95.0|-17.44|11.99|||ANCOVA|||Triglycerides (TG)||11.99|-17.44|0.716
73867293|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-15.6||||0.038|TWO_SIDED|95.0|-30.3|-0.86|||ANCOVA|||Triglycerides (TG)||-0.86|-30.30|0.038
74031126|NCT01729598|147615690|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
74031127|NCT01729598|147615691|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
74031128|NCT01729598|147615692|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
73974045|NCT01992913|147492009|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 6 month assessment.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|4.42|<|0.99|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.99
73974046|NCT01992913|147492009|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 12 month assessment.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|4.54|<|0.94|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.94
73974047|NCT01992913|147492009|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the baseline assessment.|Mean Difference (Final Values)|-6.67|STANDARD_ERROR_OF_MEAN|4.52|<|0.14|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.14
73974048|NCT01499368|147492136|NON_INFERIORITY|Non-inferiority: The Lower limit is not lower than -15%||||||0.05|||||||Chi-squared|||||||0.05
74089059|NCT03575871|147731425|SUPERIORITY||Difference in Percentage|50.5|||<|0.0001|TWO_SIDED|95.0|40.0|60.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.9|40.0|<0.0001
74089060|NCT03575871|147731426|SUPERIORITY||Difference in Percentage|19.2||||0.0002|TWO_SIDED|95.0|11.0|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.4|11.0|0.0002
73940461|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.08|STANDARD_DEVIATION|0.36||0.04|TWO_SIDED|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.79|0.04
73940462|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.4||0.22|TWO_SIDED|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.12|0.22
73940463|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.26|STANDARD_DEVIATION|0.41||0.14|TWO_SIDED|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-1.07|0.14
73974049|NCT01499368|147492137|NON_INFERIORITY|Non-Inferiority||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||0.05
73974050|NCT03215706|147492171|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.69||||0.0006|TWO_SIDED|95.0|0.56|0.86|||Log-rank test stratified|||||0.86|0.56|0.0006
73974051|NCT03215706|147492172|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.7||||0.0001|TWO_SIDED|95.0|0.58|0.84|||Log-rank test stratified|||||0.84|0.58|0.0001
73974052|NCT03215706|147492173|SUPERIORITY|Treatment A over Treatment B|Odds Ratio (OR)|1.81||||0.0003|TWO_SIDED|95.0|1.31|2.5|||Mantel Haenszel|||||2.50|1.31|0.0003
73974053|NCT03512301|147492195|OTHER||Accuracy|0.6587|||||TWO_SIDED|95.0|0.569|0.7408||||||||0.7408|0.5690|
73974054|NCT03512301|147492195|OTHER||Sensitivity|0.8736|||||TWO_SIDED|||||||||||||
74089061|NCT03575871|147731426|SUPERIORITY||Difference in Percentage|31.2|||<|0.0001|TWO_SIDED|95.0|22.3|40.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.2|22.3|<0.0001
74089062|NCT03575871|147731426|SUPERIORITY||Difference in Percentage|27.5|||<|0.0001|TWO_SIDED|95.0|18.9|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.2|18.9|<0.0001
73974055|NCT03512301|147492195|OTHER||Specificity|0.4872|||||TWO_SIDED|||||||||||||
73940464|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.43||0.36|TWO_SIDED|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.29|-1.40|0.36
73940465|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.1|STANDARD_DEVIATION|0.41||0.07|TWO_SIDED|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.89|0.07
73974056|NCT03512301|147492195|OTHER||Positive Predictive Value|0.7917|||||TWO_SIDED|||||||||||||
73974057|NCT03512301|147492195|OTHER||Negative Predictive Value|0.6333|||||TWO_SIDED|||||||||||||
73974058|NCT03512301|147492195|OTHER||Sensitivity|0.1212|||||TWO_SIDED|||||||||||||
73974059|NCT03512301|147492195|OTHER||Specificity|0.9032|||||TWO_SIDED|||||||||||||
73974060|NCT03512301|147492195|OTHER||Positive Predictive Value|0.3077|||||TWO_SIDED|||||||||||||
73974061|NCT03512301|147492195|OTHER||Negative Predictive Value|0.7434|||||TWO_SIDED|||||||||||||
73974062|NCT03512301|147492195|OTHER||Sensitivity|0.5|||||TWO_SIDED|||||||||||||
73974063|NCT03512301|147492195|OTHER||Specificity|0.8833|||||TWO_SIDED|||||||||||||
73974064|NCT03512301|147492195|OTHER||Positive Predictive Value|0.1765|||||TWO_SIDED|||||||||||||
73974065|NCT03512301|147492195|OTHER||Negative Predictive Value|0.9725|||||TWO_SIDED|||||||||||||
73974066|NCT03512301|147492195|OTHER||Quadratic Weighted Kappa|0.4446|||||TWO_SIDED|95.0|0.2791|0.6101||||||||0.6101|0.2791|
73974067|NCT03512301|147492196|OTHER|Linear Regression. Power calculations for linear regression between CAMCI and MoCA were found to be sufficiently powered with a Pearson's R of at least 0.3 at 80% power and that equated to a test-set size of 98.|Pearson Correlation|0.5073|||||TWO_SIDED|95.0|0.3892|0.6091|||||Linear Regression Equation: \[CAMCI Score\] = -5.42 + 1.40 X \[MoCA Score\]|||0.6091|0.3892|
73974068|NCT03512301|147492196|OTHER||Accuracy|0.5556|||||TWO_SIDED|95.0|0.4644|0.644||||||||0.6440|0.4644|
73940466|NCT02130193|147412892|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.3|STANDARD_DEVIATION|0.42||0.17|TWO_SIDED|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.54|-1.12|0.17
73940467|NCT01297959|147412897|SUPERIORITY|||||||0.39|||||||Regression, Logistic|p-value was based on a logistic regression (Chi-square test) model with treatment group as a factor, adjusting for the stratification factors.||||||0.39
73940468|NCT01297959|147412898|SUPERIORITY|||||||0.34|||||||Regression, Logistic|p-value was based on a logistic regression (Chi-square test) model with treatment group as a factor, adjusting for the stratification factors.||||||0.34
73940469|NCT01712009|147412941|SUPERIORITY_OR_OTHER||Difference|-6.3|||||TWO_SIDED|95.0|-16.7|4.1|||||Naproxen minus No Prophylaxis|||4.1|-16.7|
73940470|NCT01712009|147412941|SUPERIORITY_OR_OTHER||Difference|-4.1|||||TWO_SIDED|95.0|-14.5|6.3|||||Loratadine minus No Prophylaxis|||6.3|-14.5|
74031129|NCT00844428|147615706|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|80.0|||||TWO_SIDED|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS."||94|56|
74031130|NCT00844428|147615707|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
73940471|NCT01712009|147412941|SUPERIORITY_OR_OTHER||Difference|2.2|||||TWO_SIDED|95.0|-8.0|12.4|||||Loratadine minus Naproxen|||12.4|-8.0|
73940472|NCT01712009|147412942|SUPERIORITY_OR_OTHER||Difference|-4.2|||||TWO_SIDED|95.0|-14.4|6.0|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles||6.0|-14.4|
73940473|NCT01712009|147412942|SUPERIORITY_OR_OTHER||Difference|-2.4|||||TWO_SIDED|95.0|-12.5|7.8|||||Loratadine minus No Prophylaxis|Difference across all treatment cyces||7.8|-12.5|
73940474|NCT01712009|147412942|SUPERIORITY_OR_OTHER||Difference|1.8|||||TWO_SIDED|95.0|-8.3|12.0|||||Loratadine minus Naproxen|Dfference across all treatment cycles||12.0|-8.3|
73940475|NCT01712009|147412943|SUPERIORITY_OR_OTHER||Difference|-1.7|||||TWO_SIDED|95.0|-6.5|3.2|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles||3.2|-6.5|
73940476|NCT01712009|147412943|SUPERIORITY_OR_OTHER||Difference|-1.3|||||TWO_SIDED|95.0|-6.1|3.6|||||Loratadine minus No Prophylaxis|Difference across all cycles||3.6|-6.1|
73940477|NCT01712009|147412943|SUPERIORITY_OR_OTHER||Difference|0.4|||||TWO_SIDED|95.0|-4.1|4.9|||||Loratadine minus Naproxen|Difference across all cycles||4.9|-4.1|
73940478|NCT01712009|147412944|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0881|TWO_SIDED|95.0|-0.7|0.0|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.0|-0.7|0.0881
73940479|NCT01712009|147412944|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_DEVIATION|0.2||0.0443|TWO_SIDED|95.0|-0.7|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.0|-0.7|0.0443
73940480|NCT01712009|147412944|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.8007|TWO_SIDED|95.0|-0.4|0.3|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles||0.3|-0.4|0.8007
73940481|NCT01712009|147412945|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1466|TWO_SIDED|95.0|-1.1|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.2|-1.1|0.1466
73940482|NCT01712009|147412945|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0411|TWO_SIDED|95.0|-1.3|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.0|-1.3|0.0411
73940483|NCT01712009|147412945|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5689|TWO_SIDED|95.0|-0.8|0.5|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles||0.5|-0.8|0.5689
73940484|NCT01712009|147412946|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.0775||95.0|-3.0|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.2|-3.0|0.0775
73940485|NCT01712009|147412946|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.0329|TWO_SIDED|95.0|-3.1|-0.1|||ANCOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.1|-3.1|0.0329
73940486|NCT01712009|147412946|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7572|TWO_SIDED|95.0|-1.7|1.2|||ANOVA||Loratadine minus Naproxen|Difference across all treatment groups||1.2|-1.7|0.7572
73940487|NCT01751126|147412949|SUPERIORITY||LS Mean|0.76||||0.007|TWO_SIDED|95.0|0.26|1.27||ANCOVA with treatment as well as the baseline CFS and the exposure to Vernal keratoconjunctivitis (VKC) seasons (Hochberg procedure).|t-test, 2 sided|||||1.27|0.26|0.007
73940488|NCT01751126|147412949|SUPERIORITY||LS Mean|0.67||||0.01|TWO_SIDED|95.0|0.16|1.18|||ANCOVA|ANCOVA with treatment as well as the baseline CFS and the exposure to Vernal keratoconjunctivitis (VKC) seasons (Hochberg procedure).||||1.18|0.16|0.010
73940489|NCT01986881|147412965|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|0.97|||<|0.001|TWO_SIDED|95.6|0.848|1.114||Model included treatment as an explanatory factor and cohort category as a stratification factor.|Cox Proportional Hazards Model|||||1.114|0.848|<0.001
73940490|NCT01986881|147412965|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|1.04||||0.002|TWO_SIDED|95.6|0.887|1.211|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.211|0.887|0.002
73940491|NCT01986881|147412965|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|0.91|||<|0.001|TWO_SIDED|95.6|0.773|1.065|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.065|0.773|<0.001
73940492|NCT01986881|147412967|SUPERIORITY||Difference in the Least Squares Means|-0.65|||<|0.001|TWO_SIDED|95.0|-0.78|-0.51||"Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and Time was a categorical variable."|cLDA Model|||||-0.51|-0.78|<0.001
73940493|NCT01986881|147412967|SUPERIORITY||Difference in the Least Squares Means|-0.58|||<|0.001|TWO_SIDED|95.0|-0.71|-0.44||"Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and Time was a categorical variable."|Constrained longitudinal data analysis|||||-0.44|-0.71|<0.001
73940494|NCT01986881|147412969|SUPERIORITY||Difference in the Least Squares Means|-0.22||||0.247|TWO_SIDED|95.0|-0.6|0.16||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA Model|||||0.16|-0.60|0.247
73940495|NCT01986881|147412969|SUPERIORITY||Difference in the Least Squares Means|-0.35||||0.063|TWO_SIDED|95.0|-0.72|0.02||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA model|||||0.02|-0.72|0.063
73940496|NCT01986881|147412971|SUPERIORITY||Difference in the Least Squares Means|-0.75|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA Model|||||-0.53|-0.98|<0.001
73940497|NCT01986881|147412971|SUPERIORITY||Difference in the Least Squares Means|-0.66|||<|0.001|TWO_SIDED|95.0|-0.89|-0.43||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA model|||||-0.43|-0.89|<0.001
73940498|NCT01986881|147412972|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.108|TWO_SIDED|95.8|0.75|1.034|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.034|0.750|0.108
73940499|NCT01986881|147412972|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.15|TWO_SIDED|95.8|0.725|1.057|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.057|0.725|0.150
73974069|NCT03512301|147492196|OTHER||Sensitivity|0.9747|||||TWO_SIDED|||||||||||||
73940500|NCT01986881|147412972|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.188|TWO_SIDED|95.8|0.735|1.068|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.068|0.735|0.188
73940501|NCT01986881|147412973|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.385|TWO_SIDED|95.8|0.767|1.113|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.113|0.767|0.385
73940502|NCT01986881|147412973|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.417|TWO_SIDED|95.8|0.739|1.139|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.139|0.739|0.417
73940503|NCT01986881|147412973|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.494|TWO_SIDED|95.8|0.75|1.154|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.154|0.750|0.494
73940504|NCT01986881|147412974|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.081|TWO_SIDED|95.8|0.63|1.036|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.036|0.630|0.081
73940505|NCT01986881|147412974|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.258|TWO_SIDED|95.8|0.638|1.137|||Cox Proportional Hazard Model|"Model included treatment as an explanatory factor and cohort category as a stratification factor.~Renal"||||1.137|0.638|0.258
73940506|NCT01986881|147412974|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.065|TWO_SIDED|95.8|0.568|1.028|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.028|0.568|0.065
73940507|NCT01986881|147412975|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.183|TWO_SIDED|95.0|0.823|1.038||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||1.038|0.823|0.183
73940508|NCT01986881|147412975|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.45|TWO_SIDED|95.0|0.831|1.086|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.086|0.831|0.450
73940509|NCT01986881|147412975|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.123|TWO_SIDED|95.0|0.785|1.029|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.029|0.785|0.123
73940510|NCT01986881|147412976|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.676|TWO_SIDED|95.0|0.861|1.259|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.259|0.861|0.676
73940511|NCT01986881|147412976|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.139|TWO_SIDED|95.0|0.949|1.451|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.451|0.949|0.139
73940512|NCT01986881|147412976|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.416|TWO_SIDED|95.0|0.727|1.141|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.141|0.727|0.416
73974070|NCT03512301|147492196|OTHER||Specificity|0.3913|||||TWO_SIDED|||||||||||||
73974071|NCT03512301|147492196|OTHER||Positive Predictive Value|0.5625|||||TWO_SIDED|||||||||||||
73974072|NCT03512301|147492196|OTHER||Negative Predictive Value|0.9|||||TWO_SIDED|||||||||||||
73974073|NCT03512301|147492196|OTHER||Sensitivity|0.1905|||||TWO_SIDED|||||||||||||
73974074|NCT03512301|147492196|OTHER||Specificity|0.9841|||||TWO_SIDED|||||||||||||
73974075|NCT03512301|147492196|OTHER||Positive Predictive Value|0.9231|||||TWO_SIDED|||||||||||||
73974076|NCT03512301|147492196|OTHER||Negative Predictive Value|0.5487|||||TWO_SIDED|||||||||||||
73867294|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-7.0||||0.213|TWO_SIDED|95.0|-18.15|4.06|||ANCOVA|||Triglycerides (TG)||4.06|-18.15|0.213
73867295|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-1.7||||0.806|TWO_SIDED|95.0|-15.38|11.96|||ANCOVA|||Triglycerides (TG)||11.96|-15.38|0.806
73940513|NCT01986881|147412977|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.663|TWO_SIDED|95.0|0.82|1.365||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|||1.365|0.820|0.663
73940514|NCT01986881|147412977|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.415|TWO_SIDED|95.0|0.845|1.505||A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.||1.505|0.845|0.415
73974077|NCT03512301|147492196|OTHER||Sensitivity|0.6667|||||TWO_SIDED|||||||||||||
73974078|NCT03512301|147492196|OTHER||Specificity|0.8917|||||TWO_SIDED|||||||||||||
73974079|NCT03512301|147492196|OTHER||Positive Predictive Value|0.2353|||||TWO_SIDED|||||||||||||
73974080|NCT03512301|147492196|OTHER||Negative Predictive Value|0.9817|||||TWO_SIDED|||||||||||||
73974081|NCT03512301|147492196|OTHER||Quadratic Weighted Kappa|0.3931|||||TWO_SIDED|95.0|0.2401|0.5461||||||||0.5461|0.2401|
73974082|NCT04174170|147492199|SUPERIORITY||Treatment Difference|1.03||||0.5165|TWO_SIDED|95.0|-2.09|4.16|||MMRM|||||4.16|-2.09|0.5165
73974083|NCT04174170|147492199|SUPERIORITY||Treatment Difference|-0.71||||0.6593|TWO_SIDED|95.0|-3.88|2.46|||MMRM|||||2.46|-3.88|0.6593
74031131|NCT00844428|147615708|SUPERIORITY_OR_OTHER||Percent of complete TMA response|25.0|||||TWO_SIDED|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||49|9|
74031132|NCT00844428|147615709|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
74031133|NCT00844428|147615710|SUPERIORITY_OR_OTHER||LS mean change from baseline|6.75||||0.5423|TWO_SIDED|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||29.23|-15.73|0.5423
74031134|NCT00844428|147615711|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
73867296|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-2.3||||0.739|TWO_SIDED|95.0|-15.8|11.21|||ANCOVA|||Triglycerides (TG)||11.21|-15.80|0.739
73867297|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|1.4||||0.837|TWO_SIDED|95.0|-12.36|15.26|||ANCOVA|||Triglycerides (TG)||15.26|-12.36|0.837
73867298|NCT03100058|147279826|OTHER||Mean Difference (Net)|-11.4||||0.049|TWO_SIDED|95.0|-22.71|-0.07|||ANCOVA|||Triglycerides (TG)||-0.07|-22.71|0.049
73867299|NCT03100058|147279826|OTHER|Dose finding study|Median Difference (Net)|1.3||||0.764|TWO_SIDED|95.0|-7.22|9.82|||ANCOVA|||Total Cholesterol (TC)||9.82|-7.22|0.764
73867300|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|2.6||||0.571|TWO_SIDED|95.0|-6.43|11.63|||ANCOVA|||Total Cholesterol (TC)||11.63|-6.43|0.571
73867301|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|0.1||||0.987|TWO_SIDED|95.0|-9.3|9.46|||ANCOVA|||Total Cholesterol (TC)||9.46|-9.30|0.987
73974084|NCT04174170|147492200|SUPERIORITY||Treatment Difference|0.03||||0.8215|TWO_SIDED|95.0|-0.25|0.31||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||0.31|-0.25|0.8215
73974085|NCT04174170|147492200|SUPERIORITY||Treatment Difference|-0.03||||0.8584|TWO_SIDED|95.0|-0.31|0.26||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||0.26|-0.31|0.8584
73974086|NCT04174170|147492201|SUPERIORITY||Treatment Difference|-4.16||||0.2331|TWO_SIDED|95.0|-11.0|2.69||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||2.69|-11.00|0.2331
73974087|NCT04174170|147492201|SUPERIORITY||Treatment Difference|-8.83||||0.0134|TWO_SIDED|95.0|-15.82|-1.85||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||-1.85|-15.82|0.0134
73974088|NCT04586244|147492466|SUPERIORITY|||||||0.0925|||||||paired t-test|The paired t-test used n-1 degrees of freedom, where n is the number of evaluable paired samples.||||||0.0925
73974089|NCT03142009|147492504|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.021|TWO_SIDED|95.0|-0.45|-0.04|||Mixed Models Analysis|||||-.04|-.45|.021
73974090|NCT03142009|147492505|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.075|TWO_SIDED|95.0|-0.01|0.15|||Mixed Models Analysis|||||0.15|-.01|.075
73867302|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|9.9||||0.006|TWO_SIDED|95.0|2.85|16.87|||ANCOVA|||Total Cholesterol (TC)||16.87|2.85|0.006
74031135|NCT00844428|147615712|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|95.0|||||TWO_SIDED|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||100|75|
74031136|NCT00844428|147615713|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
73867303|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-3.3||||0.463|TWO_SIDED|95.0|-12.03|5.48|||ANCOVA|||Total Cholesterol (TC)||5.48|-12.03|0.463
73867304|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|0.4||||0.925|TWO_SIDED|95.0|-8.18|9.01|||ANOVA|||Total Cholesterol (TC)||9.01|-8.18|0.925
73867305|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|1.7||||0.711|TWO_SIDED|95.0|-7.19|10.53|||ANCOVA|||Total Cholesterol (TC)||10.53|-7.19|0.711
73867306|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|4.1||||0.265|TWO_SIDED|95.0|-3.1|11.26|||ANCOVA|||Total Cholesterol (TC)||11.26|-3.10|0.265
73867307|NCT03100058|147279826|OTHER|Dose finding study|Median Difference (Net)|0.0||||0.995|TWO_SIDED|95.0|-7.31|7.36|||ANCOVA|||HDL Cholesterol||7.36|-7.31|0.995
73867308|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|4.1||||0.288|TWO_SIDED|95.0|-3.52|11.81|||ANCOVA|||HDL Cholesterol||11.81|-3.52|0.288
73940515|NCT01986881|147412977|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.953|TWO_SIDED|95.0|0.736|1.334||A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.||1.334|0.736|0.953
73940516|NCT01986881|147412978|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.006|TWO_SIDED|95.0|0.539|0.902||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||0.902|0.539|0.006
73974091|NCT02951052|147492519|NON_INFERIORITY|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA \>=50 copies/mL) can be concluded if the upper bound of a two-sided 95% confidence interval for the difference in failure rates between the two treatment arms (CAB - current ART) is not more than 6%.|Adjusted difference in proportion|0.6|||||TWO_SIDED|95.0|-1.2|2.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).|||2.5|-1.2|
73867309|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|4.5||||0.269|TWO_SIDED|95.0|-3.5|12.5|||ANCOVA|||HDL Cholesterol||12.50|-3.50|0.269
73867310|NCT03100058|147279826|OTHER|Dose finding study|Median Difference (Net)|7.3||||0.018|TWO_SIDED|95.0|1.23|13.27|||ANCOVA|||HDL Cholesterol||13.27|1.23|0.018
73867311|NCT03100058|147279826|OTHER|Dose finding study|Median Difference (Net)|2.2||||0.565|TWO_SIDED|95.0|-5.32|9.73|||ANCOVA|||HDL Cholesterol||9.73|-5.32|0.565
73867312|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|1.7||||0.649|TWO_SIDED|95.0|-5.67|9.09|||ANCOVA|||HDL Cholesterol||9.09|-5.67|0.649
73940517|NCT01986881|147412978|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.016|TWO_SIDED|95.0|0.502|0.932|||Cox Proportional Hazards Model|Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.||||0.932|0.502|0.016
73940518|NCT01986881|147412978|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.028|TWO_SIDED|95.0|0.524|0.964|||Cox Proportional Hazards Model|Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.||||0.964|0.524|0.028
73867313|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|0.7||||0.847|TWO_SIDED|95.0|-6.87|8.36|||ANCOVA|||HDL Cholesterol||8.36|-6.87|0.847
73867314|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|7.3||||0.02|TWO_SIDED|95.0|1.14|13.43|||ANCOVA|||HDL Cholesterol||13.43|1.14|0.020
73867315|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-3.8||||0.579|TWO_SIDED|95.0|-17.09|9.57|||ANCOVA|||LDL Cholesterol||9.57|-17.09|0.579
73867316|NCT03100058|147279826|OTHER||Mean Difference (Net)|5.0||||0.487|TWO_SIDED|95.0|-9.08|19.02|||ANCOVA|||LDL Cholesterol||19.02|-9.08|0.487
73867317|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-4.3||||0.561|TWO_SIDED|95.0|-18.96|10.3|||ANCOVA|||LDL Cholesterol||10.30|-18.96|0.561
73867318|NCT03100058|147279826|OTHER||Mean Difference (Net)|9.3||||0.097|TWO_SIDED|95.0|-1.68|20.25|||ANCOVA|||LDL Cholesterol||20.25|-1.68|0.097
73867319|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-8.4||||0.227|TWO_SIDED|95.0|-22.1|5.26|||ANCOVA|||LDL Cholesterol||5.26|-22.10|0.227
73867320|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-3.8||||0.58|TWO_SIDED|95.0|-17.22|9.64|||ANCOVA|||LDL Cholesterol||9.64|-17.22|0.580
73867321|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-4.8||||0.494|TWO_SIDED|95.0|-18.67|9.03|||ANCOVA|||LDL Cholesterol||9.03|-18.67|0.494
73867322|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|-1.6||||0.782|TWO_SIDED|95.0|-12.81|9.65|||ANCOVA|||LDL Cholesterol||9.65|-12.81|0.782
73867323|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|1.9||||0.816|TWO_SIDED|95.0|-13.82|17.54|||ANCOVA|||Triglycerides (TG)||17.54|-13.82|0.816
73867324|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|8.02||||0.341|TWO_SIDED|95.0|-8.13|23.42|||ANCOVA|||Triglycerides (TG)||23.42|-8.13|0.341
73867325|NCT03100058|147279826|OTHER|Dose finding study|Median Difference (Net)|9.99||||0.566|TWO_SIDED|95.0|-25.39|13.91|||ANCOVA|||Triglycerides (TG)||13.91|-25.39|0.566
73867326|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|2.98||||0.405|TWO_SIDED|95.0|-3.38|8.36|||ANCOVA|||Total Cholesterol (TC)||8.36|-3.38|0.405
73867327|NCT03100058|147279826|OTHER|Dose finding study|Median Difference (Net)|2.0||||0.511|TWO_SIDED|95.0|-3.92|7.87|||ANCOVA|||Total Cholesterol (TC)||7.87|-3.92|0.511
73867328|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|2.5||||0.506|TWO_SIDED|95.0|-4.83|9.79|||ANCOVA|||Total Cholesterol (TC)||9.79|-4.83|0.506
73867329|NCT03100058|147279826|OTHER|Dose finding study|Median Difference (Net)|3.3||||0.392|TWO_SIDED|95.0|-4.2|10.7|||ANCOVA|||HDL Cholesterol||10.70|-4.20|0.392
73867330|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|3.0||||0.426|TWO_SIDED|95.0|-4.45|10.53|||ANOVA|||HDL Cholesterol||10.53|-4.45|0.426
73867331|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|8.5||||0.071|TWO_SIDED|95.0|-0.72|17.8|||ANCOVA|||HDL Cholesterol||17.80|-0.72|0.071
73867332|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|2.9||||0.498|TWO_SIDED|95.0|-5.56|11.42|||ANCOVA|||LDL Cholesterol||11.42|-5.56|0.498
73867333|NCT03100058|147279826|OTHER|Dose finding study|Median Difference (Net)|2.4||||0.586|TWO_SIDED|95.0|-6.17|10.9|||ANCOVA|||LDL Cholesterol||10.90|-6.17|0.586
73867334|NCT03100058|147279826|OTHER|Dose finding study|Mean Difference (Net)|2.1||||0.696|TWO_SIDED|95.0|-8.47|12.67|||ANCOVA|||LDL Cholesterol||12.67|-8.47|0.696
73867335|NCT00774800|147279836|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.54||||0.0011||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0011
73940519|NCT01986881|147412979|SUPERIORITY|Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date.|Hazard Ratio (HR)|0.93||||0.34|TWO_SIDED|95.0|0.797|1.081||Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||1.081|0.797|0.340
73940520|NCT01986881|147412979|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.463|TWO_SIDED|95.0|0.784|1.117|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.117|0.784|0.463
73940521|NCT01986881|147412979|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.363|TWO_SIDED|95.0|0.771|1.1|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.100|0.771|0.363
73867336|NCT00774800|147279836|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|3.06|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
74008411|NCT03627767|147566508|SUPERIORITY||LSM difference|-0.9|||||TWO_SIDED|95.0|-1.3|-0.6||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.3|
73867337|NCT00774800|147279837|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.35||||0.0057||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0057
73867338|NCT00774800|147279837|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.66|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
73867339|NCT00774800|147279838|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-18.33|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
73867340|NCT00774800|147279838|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-62.46||||0.0018|||||||ANOVA|Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0018
73867341|NCT00479856|147279847|SUPERIORITY_OR_OTHER||percentage of participants|33.3||||||95.0|7.5|70.1||||||||70.1|7.5|
73940522|NCT01986881|147412980|SUPERIORITY|Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach includes confirmed events that occurred between the randomization date and the on-study censor date.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.898|1.131||||||||1.131|0.898|
73940523|NCT01986881|147412980|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.937|1.219||||||||1.219|0.937|
73940524|NCT01986881|147412980|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.828|1.085||||||||1.085|0.828|
73940525|NCT01986881|147412981|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.716|0.945||||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach included confirmed events that occurred between randomization date and the on-study censor date.||0.945|0.716|
73940526|NCT01986881|147412981|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.673|0.935|||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.|||0.935|0.673|
73867342|NCT01122849|147279886|SUPERIORITY_OR_OTHER||Least Square (LS) Mean difference|-0.12||||0.5456|TWO_SIDED|95.0|-0.52|0.28||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.28|-0.52|0.5456
73867343|NCT01122849|147279886|SUPERIORITY_OR_OTHER||LS mean difference|-0.34||||0.1029|TWO_SIDED|95.0|-0.75|0.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.07|-0.75|0.1029
73867344|NCT01122849|147279886|SUPERIORITY_OR_OTHER||LS mean difference|0.22||||0.2879|TWO_SIDED|95.0|-0.19|0.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.62|-0.19|0.2879
73867345|NCT01122849|147279886|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.8213|TWO_SIDED|95.0|-0.45|0.56||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7||0.56|-0.45|0.8213
73867346|NCT01122849|147279886|SUPERIORITY_OR_OTHER||LS Mean difference|-0.24||||0.3457||95.0|-0.74|0.27||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7||0.27|-0.74|0.3457
73867347|NCT01122849|147279886|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.2364|TWO_SIDED|95.0|-0.2|0.79|||ANCOVA|||Comparison for Q3 at Day 7||0.79|-0.20|0.2364
73867348|NCT01122849|147279886|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.3553|TWO_SIDED|95.0|-0.21|0.57||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.57|-0.21|0.3553
73867349|NCT01122849|147279886|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.3369|TWO_SIDED|95.0|-0.58|0.2||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.20|-0.58|0.3369
73867350|NCT01122849|147279886|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.0591|TWO_SIDED|95.0|-0.01|0.76||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.76|-0.01|0.0591
73867351|NCT01122849|147279886|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.7686|TWO_SIDED|95.0|-0.42|0.31||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q18 at Day 7||0.31|-0.42|0.7686
73867352|NCT01122849|147279886|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.46||||0.0151|TWO_SIDED|95.0|-0.83|-0.09|||ANCOVA|||Comparison of Q18 at Day 7||-0.09|-0.83|0.0151
73867353|NCT01122849|147279886|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.0256|TWO_SIDED|95.0|0.05|0.77||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 7||0.77|0.05|0.0256
73867354|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11||||0.5958|TWO_SIDED|95.0|-0.52|0.3||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1at Day 14||0.30|-0.52|0.5958
73940527|NCT01986881|147412981|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.725|1.001|||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.|||1.001|0.725|
73940528|NCT01986881|147412982|SUPERIORITY||Difference in the Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.55|-0.46|||cLDA Model|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.46|-0.55|<0.001
73940529|NCT01986881|147412982|SUPERIORITY||Difference in the Least Squares Means|-0.48|||<|0.001|TWO_SIDED|95.0|-0.53|-0.44|||cLDA model|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.44|-0.53|<0.001
73940530|NCT01986881|147412983|SUPERIORITY||Difference in the Least Squares Means|-0.48|||<|0.001|TWO_SIDED|95.0|-0.54|-0.43|||Constrained Longitudinal Data Analysis|Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.43|-0.54|<0.001
74008994|NCT01540825|147568693|SUPERIORITY_OR_OTHER||Slope|1.2472|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|1.1831|1.3112|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (powder in bottle (PIB)) for Cmax was analysed.||1.3112|1.1831|
73867355|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31||||0.1429|TWO_SIDED|95.0|-0.73|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 14||0.11|-0.73|0.1429
73867356|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.3348|TWO_SIDED|95.0|-0.21|0.62|||ANCOVA|||Comparison of Q1 at Day 14||0.62|-0.21|0.3348
73867357|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.4425||95.0|-0.32|0.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14||0.72|-0.32|0.4425
73867358|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.4795|TWO_SIDED|95.0|-0.71|0.34|||ANCOVA|||Comparison of Q3 at Day 14||0.34|-0.71|0.4795
73867359|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.1375|TWO_SIDED|95.0|-0.13|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14||0.90|-0.13|0.1375
73867360|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.575|TWO_SIDED|95.0|-0.56|0.31||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||0.31|-0.56|0.5750
73867361|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.0337|TWO_SIDED|95.0|-0.92|-0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||-0.04|-0.92|0.0337
73867362|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.1061|TWO_SIDED|95.0|-0.08|0.79||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||0.79|-0.08|0.1061
73867363|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.7092|TWO_SIDED|95.0|-0.5|0.34||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 14||0.34|-0.50|0.7092
73867364|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean difference|-0.49||||0.025|TWO_SIDED|95.0|-0.91|-0.06||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day14||-0.06|-0.91|0.0250
73940531|NCT01986881|147412983|SUPERIORITY||Difference in the Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.55|-0.45|||Constrained Longitudinal Data Analysis|Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.45|-0.55|<0.001
73940532|NCT01986881|147412984|SUPERIORITY||Difference in the least squares means|-0.37|||<|0.001|TWO_SIDED|95.0|-0.45|-0.3||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||Ertugliflozin vs. Placebo|||-0.30|-0.45|<0.001
73940533|NCT01986881|147412984|SUPERIORITY||Difference in Least Squares Means|-0.39|||<|0.001|TWO_SIDED|95.0|-0.46|-0.32||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|Ertugliflozin vs. Placebo.||||-0.32|-0.46|<0.001
73940534|NCT01986881|147412986|SUPERIORITY||Difference in the least squares means|-0.31||||0.001|TWO_SIDED|95.0|-0.41|-0.21||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-0.21|-0.41|0.001
73940535|NCT01986881|147412986|SUPERIORITY||Difference in the least squares means|-0.36|||<|0.001|TWO_SIDED|95.0|-0.46|-0.26||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA model|||||-0.26|-0.46|<0.001
73940536|NCT01986881|147413001|SUPERIORITY||Difference in the Least Squares Means|-17.56|||<|0.001|TWO_SIDED|95.0|-19.49|-15.63|||CLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-15.63|-19.49|<0.001
73867365|NCT01122849|147279887|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.0503|TWO_SIDED|95.0|0.0|0.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q18 at Day 14||0.82|0.00|0.0503
73940537|NCT01986881|147413001|SUPERIORITY||Difference in the Least Squares Means|-15.1|||<|0.001|TWO_SIDED|95.0|-17.03|-13.17|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-13.17|-17.03|<0.001
73940538|NCT01986881|147413008|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
73940539|NCT01986881|147413008|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
73940540|NCT01986881|147413009|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
73940541|NCT01986881|147413009|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
73940542|NCT01986881|147413017|SUPERIORITY||Difference in the Least Squares Means|-2.78|||<|0.001|TWO_SIDED|95.0|-3.45|-2.1|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.10|-3.45|<0.001
73940543|NCT01986881|147413017|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-3.21|-1.86|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-3.21|<0.001
73867366|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.5462|TWO_SIDED|95.0|-1.92|3.59||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 7||3.59|-1.92|0.5462
73940544|NCT01986881|147413018|SUPERIORITY||Difference in the Least Squares Mean|-3.15|||<|0.001|TWO_SIDED|95.0|-3.85|-2.45|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.45|-3.85|<0.001
73940545|NCT01986881|147413018|SUPERIORITY||Difference in the Least Squares Means|-2.58|||<|0.001|TWO_SIDED|95.0|-3.28|-1.89|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.89|-3.28|<0.001
73940546|NCT01986881|147413019|SUPERIORITY||Difference in the Least Squares Means|-2.72|||<|0.001|TWO_SIDED|95.0|-3.57|-1.86|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-3.57|<0.001
73940547|NCT01986881|147413019|SUPERIORITY||Difference in the Least Squares Means|-2.7|||<|0.001|TWO_SIDED|95.0|-3.56|-1.85|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.85|-3.56|<0.001
73940548|NCT01986881|147413021|SUPERIORITY||Difference in the Least Squares Means|-2.6|||<|0.001|TWO_SIDED|95.0|-3.68|-1.52|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.52|-3.68|<0.001
73940549|NCT01986881|147413021|SUPERIORITY||Difference in the Least Squares Means|-2.79|||<|0.001|TWO_SIDED|95.0|-3.87|-1.71|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.71|-3.87|<0.001
73940550|NCT01986881|147413024|SUPERIORITY||Difference in the Least Squares Means|-0.96|||<|0.001|TWO_SIDED|95.0|-1.37|-0.56|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.56|-1.37|<0.001
73940551|NCT01986881|147413024|SUPERIORITY||Difference in the Least Means Squares|-0.87|||<|0.001|TWO_SIDED|95.0|-1.28|-0.47|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.47|-1.28|<0.001
73940552|NCT01986881|147413025|SUPERIORITY||Difference in the Least Squares Means|-0.81|||<|0.001|TWO_SIDED|95.0|-1.22|-0.39|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.39|-1.22|<0.001
73940553|NCT01986881|147413025|SUPERIORITY||Difference in the Least Squares Means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.24|-0.41|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.41|-1.24|<0.001
73940554|NCT01986881|147413026|SUPERIORITY||Difference in the Least Squares Means|-0.67||||0.01|TWO_SIDED|95.0|-1.19|-0.16|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.16|-1.19|0.010
73940555|NCT01986881|147413026|SUPERIORITY||Difference in the Least Squares Means|-0.71||||0.006|TWO_SIDED|95.0|-1.22|-0.2|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.20|-1.22|0.006
73940556|NCT01986881|147413028|SUPERIORITY||Difference in the least squares means|-0.78||||0.024|TWO_SIDED|95.0|-1.46|-0.1||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.10|-1.46|0.024
73940557|NCT01986881|147413028|SUPERIORITY||Difference in the least squares means|-0.81||||0.02|TWO_SIDED|95.0|-1.48|-0.13||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.13|-1.48|0.020
73940558|NCT01986881|147413031|SUPERIORITY||Difference in the Least Squares Means|-1.92|||<|0.001|TWO_SIDED|95.0|-2.07|-1.77|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.77|-2.07|<0.001
73940559|NCT01986881|147413031|SUPERIORITY||Difference in the Least Squares Means|-1.63|||<|0.001|TWO_SIDED|95.0|-1.78|-1.47|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.47|-1.78|<0.001
73867367|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.37||||0.0942|TWO_SIDED|95.0|-5.16|0.42||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for sleep problems at Day 7||0.42|-5.16|0.0942
73867368|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2||||0.0221|TWO_SIDED|95.0|0.48|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep problems at Day 7||5.93|0.48|0.0221
73867369|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean difference|-0.72||||0.6731|TWO_SIDED|95.0|-4.11|2.68||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Sleep Time problems at Day 7||2.68|-4.11|0.6731
73867370|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.57||||0.1354|TWO_SIDED|95.0|-5.98|0.83||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Sleep time problems at Day 7||0.83|-5.98|0.1354
73867371|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean difference|1.86||||0.2722|TWO_SIDED|95.0|-1.5|5.21||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep time problems at Day 7||5.21|-1.50|0.2722
73940560|NCT01986881|147413032|SUPERIORITY||Difference in the Least Squares Means|-2.45|||<|0.001|TWO_SIDED|95.0|-2.67|-2.24|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.24|-2.67|<0.001
73940561|NCT01986881|147413032|SUPERIORITY||Difference in the Least Squares Means|-2.07|||<|0.001|TWO_SIDED|95.0|-2.28|-1.86|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-2.28|<0.001
73940562|NCT01986881|147413033|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-2.83|-2.22|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.22|-2.83|<0.001
73974092|NCT02951052|147492520|NON_INFERIORITY|Non-inferiority in the proportion of participants with HIV-1 RNA\<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - current ART) is more than -10%.|Adjusted difference in proportion|-3.0|||||TWO_SIDED|95.0|-6.7|0.7|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).|||0.7|-6.7|
73974093|NCT02951052|147492594|OTHER||Adjusted difference|-0.1||||0.944|TWO_SIDED|95.0|-2.4|2.2|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||2.2|-2.4|0.944
73974094|NCT02951052|147492594|OTHER||Adjusted difference|1.0||||0.385|TWO_SIDED|95.0|-1.3|3.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||3.4|-1.3|0.385
73974095|NCT02951052|147492595|OTHER||Adjusted difference|4.9|||<|0.001|TWO_SIDED|95.0|2.8|7.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||7.1|2.8|<0.001
73974096|NCT02951052|147492595|OTHER||Adjusted difference|6.4|||<|0.001|TWO_SIDED|95.0|4.0|8.8|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||8.8|4.0|<0.001
73974097|NCT02951052|147492596|OTHER||Adjusted difference|5.3||||0.008|TWO_SIDED|95.0|1.4|9.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||9.1|1.4|0.008
73974098|NCT02951052|147492596|OTHER||Adjusted difference|2.0||||0.347|TWO_SIDED|95.0|-2.2|6.2|||ANCOVA||||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|6.2|-2.2|0.347
73867372|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean difference|-0.71||||0.6195|TWO_SIDED|95.0|-3.55|2.14||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on walking in the morning at Day 7||2.14|-3.55|0.6195
73940563|NCT01986881|147413033|SUPERIORITY||Difference in the Least Squares Means|-2.11|||<|0.001|TWO_SIDED|95.0|-2.39|-1.83|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.83|-2.39|<0.001
73867373|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.83||||0.0099|TWO_SIDED|95.0|-6.7|-0.96||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at day 7 for symptoms for walking in the morning||-0.96|-6.70|0.0099
73940564|NCT01986881|147413035|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-2.97|-2.1|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.10|-2.97|<0.001
73940565|NCT01986881|147413035|SUPERIORITY||Difference in the Least Squares Means|-2.1|||<|0.001|TWO_SIDED|95.0|-2.52|-1.68|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.68|-2.52|<0.001
73940566|NCT01986881|147413038|SUPERIORITY||Difference in the Lease Squares Means|-1.78|||||TWO_SIDED|95.0|-2.41|-1.15|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-1.15|-2.41|
73940567|NCT01986881|147413038|SUPERIORITY||Difference in the Least Squares Means|-1.19|||||TWO_SIDED|95.0|-1.82|-0.56|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-0.56|-1.82|
73940568|NCT01986881|147413039|SUPERIORITY||Difference in the Lease Squares Means|-0.88|||||TWO_SIDED|95.0|-1.58|-0.18|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-0.18|-1.58|
73974099|NCT02951052|147492597|OTHER||Adjusted difference|0.2||||0.344|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA||Treatment comparison of SF-12 total scores at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||0.7|-0.2|0.344
73974100|NCT02951052|147492597|OTHER||Adjusted difference|-0.1||||0.785|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA||Treatment comparison of SF-12 total scores at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||0.4|-0.6|0.785
73974101|NCT02951052|147492597|OTHER||Adjusted difference|0.676||||0.282|TWO_SIDED|95.0|-0.557|1.909|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||1.909|-0.557|0.282
73940569|NCT01986881|147413039|SUPERIORITY||Difference in the Least Squares Means|-0.21|||||TWO_SIDED|95.0|-0.91|0.49|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|0.49|-0.91|
73940570|NCT01986881|147413040|SUPERIORITY||Difference in the least squares means|0.25|||||TWO_SIDED|95.0|-0.59|1.08|||||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|||1.08|-0.59|
73940571|NCT01986881|147413040|SUPERIORITY||Difference in the least squares means|1.12|||||TWO_SIDED|95.0|0.28|1.95|||||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|||1.95|0.28|
73940572|NCT01986881|147413042|SUPERIORITY||Difference in the Lease Squares Means|1.48|||||TWO_SIDED|95.0|0.31|2.66|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|2.66|0.31|
73940573|NCT01986881|147413042|SUPERIORITY||Difference in the Least Squares Means|1.66|||||TWO_SIDED|95.0|0.49|2.84|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|2.84|0.49|
73940574|NCT01986881|147413066|SUPERIORITY||Difference in % vs Placebo|-0.9|||||TWO_SIDED|95.0|-2.8|0.9|||||||Miettinen \& Nurminen method|0.9|-2.8|
73940575|NCT01986881|147413066|SUPERIORITY||Difference in % vs Placebo|0.3|||||TWO_SIDED|95.0|-1.6|2.1|||||||Miettinen \& Nurminen method|2.1|-1.6|
73940576|NCT01986881|147413067|SUPERIORITY||Difference in % vs Placebo|1.3|||||TWO_SIDED|95.0|-5.8|8.4|||||||Miettinen \& Nurminen method|8.4|-5.8|
73974102|NCT02951052|147492597|OTHER||Adjusted difference|0.635||||0.327|TWO_SIDED|95.0|-0.637|1.907|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||1.907|-0.637|0.327
73974103|NCT02951052|147492597|OTHER||Adjusted difference|0.697||||0.086|TWO_SIDED|95.0|-0.1|1.494|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||1.494|-0.100|0.086
73974104|NCT02951052|147492597|OTHER||Adjusted difference|0.696||||0.092|TWO_SIDED|95.0|-0.113|1.505|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||1.505|-0.113|0.092
73940577|NCT01986881|147413067|SUPERIORITY||Difference in % vs Placebo|-1.9|||||TWO_SIDED|95.0|-9.2|5.4|||||||Miettinen \& Nurminen method|5.4|-9.2|
73940578|NCT01986881|147413068|SUPERIORITY||Difference in % vs Placebo|1.4|||||TWO_SIDED|95.0|-17.7|20.4|||||||Miettinen and Nurminen method|20.4|-17.7|
73940579|NCT01986881|147413068|SUPERIORITY||Difference in % vs Placebo|-19.9|||||TWO_SIDED|95.0|-37.5|-1.2|||||||Miettinen and Nurminen method|-1.2|-37.5|
73940580|NCT01986881|147413069|SUPERIORITY||Difference in % vs Placebo|7.9|||||TWO_SIDED|95.0|-5.1|20.5|||||||Based on Miettinen and Nurminen method|20.5|-5.1|
73940581|NCT01986881|147413069|SUPERIORITY||Difference in % vs Placebo|1.0|||||TWO_SIDED|95.0|-12.3|14.2|||||||Miettinen and Nurminen method|14.2|-12.3|
73940582|NCT01986881|147413071|SUPERIORITY||Difference in % vs Placebo|0.0|||||TWO_SIDED|95.0|-2.9|3.0|||||||Miettinen \& Nurminen method|3.0|-2.9|
73940583|NCT01986881|147413071|SUPERIORITY||Difference in % vs Placebo|-1.2|||||TWO_SIDED|95.0|-4.0|1.6|||||||Miettinen \& Nurminen method|1.6|-4.0|
73940584|NCT01986881|147413074|SUPERIORITY||Difference in the Least Squares Means|-25.4|||<|0.001|TWO_SIDED|95.0|-32.84|-17.96|||CLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-17.96|-32.84|<0.001
73940585|NCT01986881|147413074|SUPERIORITY||Difference in the Least Squares Means|-19.24|||<|0.001|TWO_SIDED|95.0|-26.8|-11.68|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-11.68|-26.80|<0.001
73940586|NCT01986881|147413075|SUPERIORITY||Difference in the Least Squares Means|-1.88|||<|0.001|TWO_SIDED|95.0|-2.37|-1.13|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-1.13|-2.37|<0.001
73940587|NCT01986881|147413075|SUPERIORITY||Difference in the Least Squares Means|-1.62|||<|0.001|TWO_SIDED|95.0|-2.12|-1.13|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-1.13|-2.12|<0.001
73940588|NCT01986881|147413076|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|2.49|||<|0.001|TWO_SIDED|95.0|1.61|3.83|||Regression, Logistic|Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||3.83|1.61|<0.001
73940589|NCT01986881|147413076|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|2.6|||<|0.001|TWO_SIDED|95.0|1.64|4.12|||Regression, Logistic|Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.12|1.64|<0.001
73974105|NCT02951052|147492600|OTHER||Adjusted difference|7.9|||<|0.001|TWO_SIDED|95.0|4.1|11.7|||ANCOVA||Treatment comparison at Week 8 for the groups CAB LA+ RPV LA and current ART is presented.|||11.7|4.1|<0.001
73940590|NCT01986881|147413077|SUPERIORITY||Difference in the Least Squares Means|-2.32||||0.025|TWO_SIDED|95.0|-4.35|-0.3|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||-0.30|-4.35|0.025
73940591|NCT01986881|147413077|SUPERIORITY||Difference in the Least Squares Means|-2.88||||0.006|TWO_SIDED|95.0|-4.94|-0.82|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||-0.82|-4.94|0.006
73974106|NCT02951052|147492600|OTHER||Adjusted difference|6.9|||<|0.001|TWO_SIDED|95.0|3.3|10.4|||ANCOVA||Treatment comparison Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||10.4|3.3|<0.001
73974107|NCT02951052|147492600|OTHER||Adjusted difference|10.7|||<|0.001|TWO_SIDED|95.0|7.1|14.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||14.4|7.1|<0.001
73974108|NCT05495945|147492629|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
73867374|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean Difference|3.12||||0.0298|TWO_SIDED|95.0|0.32|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 7||5.93|0.32|0.0298
73867375|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3||||0.7211|TWO_SIDED|95.0|-2.01|1.4||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||1.40|-2.01|0.7211
73867376|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean difference|-0.8||||0.35|TWO_SIDED|95.0|-2.51|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||0.90|-2.51|0.3500
73867377|NCT01122849|147279888|SUPERIORITY_OR_OTHER||LS Mean difference|0.5||||0.5564|TWO_SIDED|95.0|-1.19|2.18||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||2.18|-1.19|0.5564
73867378|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.6804|TWO_SIDED|95.0|-2.2|3.35||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Sleep Problems at Day 14||3.35|-2.20|0.6804
73867379|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.31||||0.3524|TWO_SIDED|95.0|-4.12|1.49||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14||1.49|-4.12|0.3524
73867380|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean Difference|1.89||||0.1739|TWO_SIDED|95.0|-0.86|4.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14||4.63|-0.86|0.1739
73867381|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean difference|1.98||||0.2463|TWO_SIDED|95.0|-1.41|5.36||Between treatment p-values and confidence intervals|ANCOVA|Between treatment p-values and confidence intervals||Comparison for Sleep time problems at Day 14||5.36|-1.41|0.2463
73867382|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean difference|0.28||||0.8677|TWO_SIDED|95.0|-3.11|3.68|||ANCOVA|||Comparison for sleep time problems at Day 14||3.68|-3.11|0.8677
73867383|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.3136|TWO_SIDED|95.0|-1.65|5.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep time problems at Day 14||5.04|-1.65|0.3136
73867384|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.9183|TWO_SIDED|95.0|-2.93|2.65||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||2.65|-2.93|0.9183
73867385|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean difference|-2.68||||0.0614|TWO_SIDED|95.0|-5.5|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||0.13|-5.50|0.0614
73867386|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean Difference|2.54||||0.0695|TWO_SIDED|95.0|-0.21|5.29||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||5.29|-0.21|0.0695
73867387|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.4947|TWO_SIDED|95.0|-1.03|2.1||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day14||2.10|-1.03|0.4947
73867388|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean difference|0.15||||0.8454|TWO_SIDED|95.0|-1.42|1.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14||1.72|-1.42|0.8454
73867389|NCT01122849|147279889|SUPERIORITY_OR_OTHER||LS Mean difference|0.38||||0.6223|TWO_SIDED|95.0|-1.17|1.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14||1.93|-1.17|0.6223
73867390|NCT01122849|147279890|SUPERIORITY_OR_OTHER||LS Mean difference|-1.34||||0.4258|TWO_SIDED|95.0|-4.68|2.01||Between treatment p-values and confidence intervals|LS Mean Difference|||Comparison at Day 7||2.01|-4.68|0.4258
73867391|NCT01122849|147279890|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.05||||0.0764|TWO_SIDED|95.0|-6.43|0.33||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7||0.33|-6.43|0.0764
73867392|NCT01122849|147279890|SUPERIORITY_OR_OTHER||LS Mean Difference|1.71||||0.2986|TWO_SIDED|95.0|-1.56|4.97||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7||4.97|-1.56|0.2986
73867393|NCT01122849|147279891|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12||||0.482|TWO_SIDED|95.0|-2.05|4.29||Between treatment p-values and confidence intervals|ANCOVA|||||4.29|-2.05|0.4820
73867394|NCT01122849|147279891|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.81||||0.2607|TWO_SIDED|95.0|-5.02|1.39||Between treatment p-values and confidence intervals|ANCOVA|||||1.39|-5.02|0.2607
73867395|NCT01122849|147279891|SUPERIORITY_OR_OTHER||LS Mean Difference|2.93||||0.0623|TWO_SIDED|95.0|-0.16|6.02||Between treatment p-values and confidence intervals|ANCOVA|||||6.02|-0.16|0.0623
73867396|NCT01122849|147279892|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.36||||0.5278|TWO_SIDED|95.0|-18.1|9.39||Between treatment p-values and confidence intervals|ANCOVA|||||9.39|-18.1|0.5278
73867397|NCT01122849|147279892|SUPERIORITY_OR_OTHER||LS Mean Difference|10.14||||0.1458|TWO_SIDED|95.0|-3.64|23.93||Between treatment p-values and confidence intervals|ANCOVA|||||23.93|-3.64|0.1458
73867398|NCT01122849|147279892|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.5||||0.037|TWO_SIDED|95.0|-28.1|-0.91||Between treatment p-values and confidence intervals.|ANCOVA|||||-0.91|-28.1|0.0370
73867399|NCT01122849|147279893|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1||||0.4483|TWO_SIDED|95.0|-18.5|8.29|||ANCOVA|Between treatment p-values and confidence intervals||||8.29|-18.5|0.4483
73974109|NCT05495945|147492630|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
73974110|NCT05495945|147492631|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
73974111|NCT05495945|147492632|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
73974112|NCT05412004|147492662|SUPERIORITY||LS Mean Change difference|-20.01|||<|0.001|TWO_SIDED|95.0|-25.82|-14.2|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-14.20|-25.82|<0.001
73974113|NCT05412004|147492662|SUPERIORITY||LS Mean Change difference|-23.77|||<|0.001|TWO_SIDED|95.0|-29.61|-17.93|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-17.93|-29.61|<0.001
73974114|NCT05412004|147492663|SUPERIORITY||LS Mean Change difference|-47.65|||<|0.001|TWO_SIDED|95.0|-65.76|-29.55|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-29.55|-65.76|<0.001
73940592|NCT01986881|147413078|SUPERIORITY||Difference in the Least Squares Means|-0.38||||0.533|TWO_SIDED|95.0|-1.56|0.81|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||0.81|-1.56|0.533
73940593|NCT01986881|147413078|SUPERIORITY||Difference in the Least Squares Means|-0.6||||0.326|TWO_SIDED|95.0|-1.81|0.6|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||0.60|-1.81|0.326
73940594|NCT01986881|147413081|SUPERIORITY||Difference in the Least Squares Means|-12.22||||0.105|TWO_SIDED|95.0|-27.03|2.06|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||2.06|-27.03|0.105
73940595|NCT01986881|147413081|SUPERIORITY||Difference in the Least Squares Means|-13.53||||0.068|TWO_SIDED|95.0|-28.06|1.0|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||1.00|-28.06|0.068
73940596|NCT01986881|147413082|SUPERIORITY||Difference in the Least Squares Means|-0.52||||0.418|TWO_SIDED|95.0|-1.79|0.75|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||0.75|-1.79|0.418
73974115|NCT05412004|147492663|SUPERIORITY||LS Mean Change difference|-56.21|||<|0.001|TWO_SIDED|95.0|-73.73|-38.7|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-38.70|-73.73|<0.001
73974116|NCT05412004|147492664|SUPERIORITY||Risk Difference (RD)|42.77|||<|0.001|TWO_SIDED|95.0|30.76|54.79|||Regression, Logistic|||||54.79|30.76|<0.001
73974117|NCT05412004|147492664|SUPERIORITY||Risk Difference (RD)|48.6|||<|0.001|TWO_SIDED|95.0|36.55|60.65|||Regression, Logistic|||||60.65|36.55|<0.001
73974118|NCT05412004|147492665|SUPERIORITY||Risk Difference (RD)|28.74|||<|0.001|TWO_SIDED|95.0|18.27|39.22|||Regression, Logistic|||||39.22|18.27|<.001
74031137|NCT00844428|147615714|SUPERIORITY_OR_OTHER||Percent of complete TMA response|55.0|||||TWO_SIDED|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||77|32|
74031138|NCT00844428|147615715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
73940597|NCT01986881|147413082|SUPERIORITY||Difference in the Least Squares Means|-1.07||||0.092|TWO_SIDED|95.0|-2.32|0.18|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||0.18|-2.32|0.092
73940598|NCT01986881|147413083|SUPERIORITY||Odds ratio relative to placebo|1.48||||0.46|TWO_SIDED|95.0|0.52|4.17|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.17|0.52|0.460
73974119|NCT05412004|147492665|SUPERIORITY||Risk Difference (RD)|33.22|||<|0.001|TWO_SIDED|95.0|22.12|44.31|||Regression, Logistic|||||44.31|22.12|<0.001
73940599|NCT01986881|147413083|SUPERIORITY||Odds ratio relative to placebo|1.62||||0.335|TWO_SIDED|95.0|0.61|4.35|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.35|0.61|0.335
73940600|NCT01986881|147413084|SUPERIORITY||Difference in the Least Squares Means|2.73||||0.255|TWO_SIDED|95.0|-2.0|7.45|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||7.45|-2.00|0.255
73940601|NCT01986881|147413084|SUPERIORITY||Difference in the Least Squares Means|2.81||||0.235|TWO_SIDED|95.0|-1.85|7.48|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||7.48|-1.85|0.235
73940602|NCT01986881|147413085|SUPERIORITY||Difference in the Least Squares Means|1.98||||0.178|TWO_SIDED|95.0|-0.91|4.86|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||4.86|-0.91|0.178
73940603|NCT01986881|147413085|SUPERIORITY||Difference in the Least Squares Means|1.73||||0.23|TWO_SIDED|95.0|-1.11|4.58|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||4.58|-1.11|0.230
73940604|NCT01986881|147413086|SUPERIORITY||Difference in the Least Squares Means|-31.37|||<|0.001|TWO_SIDED|95.0|-40.68|-22.07|||CLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-22.07|-40.68|<0.001
73974120|NCT05412004|147492666|SUPERIORITY||Median Difference (Net)|-70.13|STANDARD_ERROR_OF_MEAN|10.619|||TWO_SIDED|95.0|-90.94|-49.31||||||||-49.31|-90.94|
73974121|NCT05412004|147492666|SUPERIORITY||Median Difference (Net)|-61.29|STANDARD_ERROR_OF_MEAN|11.921|||TWO_SIDED|95.0|-84.66|-37.93||||||||-37.93|-84.66|
73974122|NCT05412004|147492667|SUPERIORITY||LS Mean Change difference|-2.03||||0.037|TWO_SIDED|95.0|-3.95|-0.12|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Disturbance||-0.12|-3.95|0.037
73974123|NCT05412004|147492667|SUPERIORITY||LS Mean Change difference|-3.43||||0.003|TWO_SIDED|95.0|-5.69|-1.17|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Related Impairment||-1.17|-5.69|0.003
74031139|NCT00844428|147615716|SUPERIORITY_OR_OTHER||LS mean change from baseline|-3.68||||0.7307|TWO_SIDED|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||17.79|-25.15|0.7307
73940605|NCT01986881|147413086|SUPERIORITY||Difference in the Least Squares Means|-30.47|||<|0.001|TWO_SIDED|95.0|-40.23|-20.72|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-20.72|-40.23|<0.001
73940606|NCT01986881|147413087|SUPERIORITY||Difference in the Least Squares Means|-1.94|||<|0.001|TWO_SIDED|95.0|-2.65|-1.24|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-1.24|-2.65|<0.001
73974124|NCT05412004|147492667|SUPERIORITY||LS Mean Change difference|-3.9|||<|0.001|TWO_SIDED|95.0|-6.21|-1.58|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Disturbance||-1.58|-6.21|<0.001
73974125|NCT05412004|147492667|SUPERIORITY||LS Mean Change difference|-4.26||||0.002|TWO_SIDED|95.0|-6.97|-1.56|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep-Related Impairment||-1.56|-6.97|0.002
73974126|NCT05412004|147492668|SUPERIORITY||LS Mean Change difference|-16.09|||<|0.001|TWO_SIDED|95.0|-17.99|-14.19|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-14.19|-17.99|<0.001
73974127|NCT05412004|147492668|SUPERIORITY||LS Mean Change difference|-17.28|||<|0.001|TWO_SIDED|95.0|-19.29|-15.28|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-15.28|-19.29|<.001
73974128|NCT05412004|147492669|SUPERIORITY||LS Mean Change difference|-0.71|STANDARD_ERROR_OF_MEAN|0.253||0.752|TWO_SIDED|95.0|-1.21|-0.22||ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.|ANCOVA|||||-0.22|-1.21|0.752
74031140|NCT00844428|147615717|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
73974129|NCT05412004|147492669|SUPERIORITY||LS Mean Change difference|-1.04|STANDARD_ERROR_OF_MEAN|0.269||0.35|TWO_SIDED|95.0|-1.57|-0.51||ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.|ANCOVA|||||-0.51|-1.57|0.350
73974130|NCT05412004|147492670|SUPERIORITY||LS Mean Change difference|-7.62|||<|0.001|TWO_SIDED|95.0|-10.48|-4.77|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-4.77|-10.48|<0.001
73940607|NCT01986881|147413087|SUPERIORITY||Difference in the Least Squares Means|-1.57|||<|0.001|TWO_SIDED|95.0|-2.3|-0.84|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-0.84|-2.30|<0.001
73974131|NCT05412004|147492670|SUPERIORITY||LS Mean difference|-3.7||||0.017|TWO_SIDED|95.0|-6.75|-0.65|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-0.65|-6.75|0.017
73974132|NCT03868930|147492705|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
74031141|NCT00772967|147615744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.611||||0.089||90.0|-1.36|0.14||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||0.14|-1.36|0.089
74031142|NCT00772967|147615744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.804||||0.043||90.0|-1.57|-0.04||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.04|-1.57|0.043
74031143|NCT00772967|147615745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.518||||0.048||90.0|-1.03|-0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.01|-1.03|0.048
74031144|NCT00772967|147615745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.001||90.0|-1.54|-0.53||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.53|-1.54|0.001
74031145|NCT00772967|147615746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.658||||0.052||90.0|-1.32|0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||0.01|-1.32|0.052
74089063|NCT03575871|147731426|SUPERIORITY||Difference in Percentage|46.4|||<|0.0001|TWO_SIDED|95.0|37.2|55.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.7|37.2|<0.0001
74089064|NCT03575871|147731426|SUPERIORITY||Difference in Percentage|27.4|||<|0.0001|TWO_SIDED|95.0|16.8|38.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.0|16.8|<0.0001
73940608|NCT01986881|147413088|SUPERIORITY||Adjusted odds ratio relative to placebo|4.1|||<|0.001|TWO_SIDED|95.0|2.0|8.42|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.||8.42|2.00|<0.001
73940609|NCT01986881|147413088|SUPERIORITY||Adjusted odds ratio relative to placebo|5.97|||<|0.001|TWO_SIDED|95.0|2.86|12.49|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.||12.49|2.86|<0.001
74031146|NCT00772967|147615746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.003||90.0|-1.81|-0.49||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.49|-1.81|0.003
74031147|NCT00772967|147615747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.875||||0.019||90.0|-1.56|-0.19||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.19|-1.56|0.019
74089065|NCT03575871|147731426|SUPERIORITY||Difference in Percentage|39.8|||<|0.0001|TWO_SIDED|95.0|28.9|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||50.6|28.9|<0.0001
73940610|NCT01986881|147413089|SUPERIORITY||Difference in the Least Squares Means|-0.85||||0.597|TWO_SIDED|95.0|-4.0|2.3|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||2.30|-4.00|0.597
73940611|NCT01986881|147413089|SUPERIORITY||Difference in the Least Squares Means|-1.57||||0.351|TWO_SIDED|95.0|-4.87|1.73|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.73|-4.87|0.351
73940612|NCT01986881|147413090|SUPERIORITY||Difference in the Least Squares Means|-0.68||||0.49|TWO_SIDED|95.0|-2.6|1.25|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.25|-2.60|0.490
73940613|NCT01986881|147413090|SUPERIORITY||Difference in the Least Squares Means|-0.05||||0.958|TWO_SIDED|95.0|-2.07|1.96|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.96|-2.07|0.958
73940614|NCT05183022|147413091|SUPERIORITY|||||||0.07|||||||ANOVA|||||||0.07
73940615|NCT05616962|147413092|SUPERIORITY|||||||0.473|||||||ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||0.473
73940616|NCT05616962|147413093|SUPERIORITY|||||||0.03199|||||||paired t-test|||||||0.03199
73940617|NCT05616962|147413094|SUPERIORITY|||||||0.408|||||||ANCOVA|ANCOVA with baseline value as covariate||||||0.408
74031148|NCT00772967|147615747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.007||90.0|-1.77|-0.37||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.37|-1.77|0.007
74031149|NCT00053846|147615822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.483|STANDARD_ERROR_OF_MEAN|0.275||0.08|TWO_SIDED|95.0|-1.02|0.0576|||ANCOVA||Multiple Imputation (MI) used for estimates. MICE software in R was used to generate 100 imputed datasets. ANCOVA was run on each, and results were pooled.|H0: The true difference in means is equal to zero. Ha: The true difference in means is not equal to zero.||0.0576|-1.020|0.080
74031150|NCT03008590|147615823|SUPERIORITY|||||||0.9||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.90
73940618|NCT05616962|147413095|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73974133|NCT03868930|147492705|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
73974134|NCT03868930|147492705|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
73974135|NCT03868930|147492705|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
73974136|NCT03868930|147492706|SUPERIORITY|||||||0.0044||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0044
73974137|NCT03868930|147492706|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||<.0001
74031151|NCT03008590|147615824|SUPERIORITY|||||||0.22||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.22
73974138|NCT03868930|147492706|SUPERIORITY|||||||0.0162||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0162
74031152|NCT03008590|147615825|SUPERIORITY|||||||0.02||||||Although significance was pre-specified at P\<0.05, it is suspected that this result is spurious due to multiple comparisons|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.02
74031153|NCT03008590|147615826|SUPERIORITY|||||||0.3||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.3
74031154|NCT03008590|147615827|SUPERIORITY|||||||0.04||||||Although significance was pre-specified at P\<0.05, it is suspected that this result is spurious due to multiple comparisons|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.04
74031155|NCT03008590|147615828|SUPERIORITY|||||||0.78||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.78
74031156|NCT03008590|147615829|SUPERIORITY|||||||0.92||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.92
74031157|NCT01929044|147615857|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test relative to the non-inferiority margin of 1|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|Restricted maximum likelihood (REML) -repeated measures approach||0.04|-0.88|<0.0001
74031158|NCT01929044|147615857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.23||0.0743|TWO_SIDED|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.04|-0.88|0.0743
73940619|NCT05616962|147413096|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73940620|NCT05616962|147413097|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73940621|NCT05616962|147413098|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73940622|NCT05616962|147413099|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73974139|NCT03868930|147492706|SUPERIORITY|||||||0.0009||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0009
73974140|NCT03868930|147492707|SUPERIORITY|||||||0.014||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0140
73974141|NCT03868930|147492707|SUPERIORITY|||||||0.1548||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.1548
74089066|NCT03575871|147731426|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|18.9|39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.6|18.9|<0.0001
74089067|NCT03575871|147731426|SUPERIORITY||Difference in Percentage|38.6|||<|0.0001|TWO_SIDED|95.0|28.1|49.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.1|28.1|<0.0001
73974142|NCT03868930|147492707|SUPERIORITY|||||||0.0302||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0302
73974143|NCT03868930|147492707|SUPERIORITY|||||||0.0158||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0158
73940623|NCT05616962|147413100|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73974144|NCT03868930|147492707|SUPERIORITY|||||||0.0034||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0034
74089068|NCT03575871|147731427|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.1|-2.3|<0.0001
74089069|NCT03575871|147731427|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.6|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.6|-2.8|<0.0001
73867400|NCT01122849|147279893|SUPERIORITY_OR_OTHER||LS Mean Difference|14.28||||0.0385|TWO_SIDED|95.0|0.79|27.77|||ANCOVA|Between treatment p-values and confidence intervals||||27.77|0.79|0.0385
73940624|NCT05616962|147413101|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
74089070|NCT03575871|147731429|SUPERIORITY||Difference in Percentage|8.8||||0.015|TWO_SIDED|95.0|2.8|14.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||14.9|2.8|0.0150
74089071|NCT03575871|147731429|SUPERIORITY||Difference in Percentage|22.7|||<|0.0001|TWO_SIDED|95.0|15.0|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.3|15.0|<0.0001
74089072|NCT03575871|147731429|SUPERIORITY||Difference in Percentage|20.0||||0.0004|TWO_SIDED|95.0|10.9|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.0|10.9|0.0004
74089073|NCT03575871|147731429|SUPERIORITY||Difference in Percentage|44.3|||<|0.0001|TWO_SIDED|95.0|34.8|53.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.8|34.8|<0.0001
73940625|NCT05616962|147413102|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73940626|NCT05616962|147413103|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73940627|NCT05616962|147413104|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73940628|NCT05616962|147413105|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73940629|NCT05616962|147413106|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73940630|NCT05616962|147413107|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73974145|NCT03868930|147492707|SUPERIORITY|||||||0.8776||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.8776
74089074|NCT03575871|147731429|SUPERIORITY||Difference in Percentage|30.4|||<|0.0001|TWO_SIDED|95.0|19.7|41.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||41.2|19.7|<0.0001
73940631|NCT05616962|147413108|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
73940632|NCT05616962|147413110|SUPERIORITY|||||||0.00463|||||||paired t-test|||||||0.00463
73940633|NCT05616962|147413111|SUPERIORITY|||||||0.23077|||||||paired t-test|||||||0.23077
74089075|NCT03575871|147731429|SUPERIORITY||Difference in Percentage|47.4|||<|0.0001|TWO_SIDED|95.0|36.8|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.0|36.8|<0.0001
73867401|NCT01122849|147279893|SUPERIORITY_OR_OTHER||LS Mean difference|-19.37||||0.0046|TWO_SIDED|95.0|-32.5|-6.23|||ANCOVA|Between treatment p-values and confidence intervals||||-6.23|-32.5|0.0046
73940634|NCT05616962|147413112|SUPERIORITY|||||||0.00849|||||||paired t-test|||||||0.00849
73940635|NCT04250727|147413123|SUPERIORITY|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||||||0.601
73940636|NCT00184548|147413187|SUPERIORITY_OR_OTHER|||||||0.934||||||Two-sided significance level 5%|Regression, Logistic|||Test for Odds ratio=1, corresponding to a null hypothesis of no difference in mortality for patients who died between groups for Blunt Trauma. Odds-ratio is adjusted for baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma -Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury (P/F \> 200). Missing covariates are imputed by the mean value.||||0.934
73867402|NCT01122849|147279894|SUPERIORITY_OR_OTHER||LS Mean Difference|15.24||||0.0029|TWO_SIDED|95.0|5.45|25.02||Between treatment p-values and confidence intervals|ANCOVA|||||25.02|5.45|0.0029
73974146|NCT03868930|147492707|SUPERIORITY|||||||0.0002||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0002
73974147|NCT03868930|147492707|SUPERIORITY|||||||0.0198||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0198
73974148|NCT03868930|147492707|SUPERIORITY|||||||0.0013||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0013
73974149|NCT03868930|147492707|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy Group from Baseline (T1) to Follow-Up (T3) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
73974150|NCT03868930|147492707|SUPERIORITY|||||||0.0345||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||.0345
73974151|NCT03868930|147492707|SUPERIORITY|||||||0.5918||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.5918
73974152|NCT05441449|147492720|SUPERIORITY|||||||0.002|||||||ANOVA|||||||0.002
73974153|NCT05441449|147492720|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73974154|NCT05441449|147492720|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73974155|NCT05441449|147492721|SUPERIORITY|||||||0.043|||||||ANOVA|||||||0.043
73974156|NCT05441449|147492721|SUPERIORITY|||||||0.281|||||||ANOVA|||||||0.281
73974157|NCT05441449|147492721|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73974158|NCT05441449|147492722|SUPERIORITY|||||||0.352|||||||ANOVA|||||||0.352
73974159|NCT05441449|147492722|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
73974160|NCT05441449|147492723|SUPERIORITY|||||||0.374|||||||ANOVA|||||||0.374
73974161|NCT05441449|147492723|SUPERIORITY|||||||0.045|||||||ANOVA|||||||0.045
73974162|NCT05441449|147492723|SUPERIORITY|||||||0.196|||||||ANOVA|||||||0.196
73974163|NCT02231749|147492724|SUPERIORITY||Stratified Difference|16.0|||<|0.0001|TWO_SIDED|95.0|9.8|22.2|||DerSimonian and Laird Test|||||22.2|9.8|<0.0001
73974164|NCT02231749|147492725|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|99.8|0.44|0.89|||Log Rank|||||0.89|0.44|<0.0001
73974165|NCT02231749|147492726|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0331|TWO_SIDED|99.1|0.64|1.05|||Log Rank|||||1.05|0.64|0.0331
73867403|NCT01122849|147279894|SUPERIORITY_OR_OTHER||LS Mean Difference|3.74||||0.4683|TWO_SIDED|95.0|-6.53|14.01||Between treatment p-values and confidence intervals|ANCOVA|||||14.01|-6.53|0.4683
73974166|NCT02231749|147492727|SUPERIORITY||Stratified Difference|7.2||||0.0191|TWO_SIDED|95.0|1.8|12.7|||DerSimonian and Laird Test|||||12.7|1.8|0.0191
73974167|NCT02231749|147492728|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0003|TWO_SIDED|99.8|0.49|0.95|||Log Rank|||||0.95|0.49|0.0003
73974168|NCT02231749|147492729|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8498|TWO_SIDED|99.1|0.79|1.23|||Log Rank|||||1.23|0.79|0.8498
73974169|NCT04868656|147492746|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.15|TWO_SIDED|95.0|-5.0|0.8|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).||0.8|-5.0|0.15
73867404|NCT01122849|147279894|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0259|TWO_SIDED|95.0|1.44|21.55||Between treatment p-values and confidence intervals|ANCOVA|||||21.55|1.44|0.0259
73867405|NCT01122849|147279895|SUPERIORITY_OR_OTHER||LS Mean Difference|7.79||||0.1764|TWO_SIDED|95.0|-3.62|19.19||Between treatment p-values and confidence intervals|ANCOVA|||||19.19|-3.62|0.1764
73974170|NCT04868656|147492747|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.34|TWO_SIDED|95.0|-6.0|16.6|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).||16.6|-6.0|0.34
73974171|NCT04868656|147492748|SUPERIORITY||Odds Ratio (OR)|0.6||||0.23|TWO_SIDED|95.0|0.1|2.5|||Regression, Logistic|||Model includes the arm indicator variable only; model does not include stratification variables due to potential for overfitting.||2.5|0.1|0.23
73974172|NCT04955431|147492769|OTHER|We performed a 2-way Repeated Measures ANOVA to compare changes in blood IL-6 levels from baseline to post simulated firefighting on control days (Normal Sleep) and experimental days (Sleep Restriction).|||||<|0.05|||||||ANOVA|||||||<0.05
73974173|NCT04955431|147492770|OTHER|RM-ANOVA|||||>|0.05|||||||ANOVA|||||||>0.05
74031159|NCT01929044|147615858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.2||0.121|TWO_SIDED|95.0|-0.7|0.08|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.08|-0.70|0.1210
73867406|NCT01122849|147279895|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.9183|TWO_SIDED|95.0|-11.7|12.94||Between treatment p-values and confidence intervals|ANCOVA|||||12.94|-11.7|0.9183
73867407|NCT01122849|147279895|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16||||0.2313||95.0|-4.7|19.01||Between treatment p-values and confidence intervals|ANCOVA|||||19.01|-4.70|0.2313
73867408|NCT01122849|147279896|SUPERIORITY_OR_OTHER||LS Mean difference|0.27||||0.1345|TWO_SIDED|95.0|-0.09|0.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.63|-0.09|0.1345
73940637|NCT00184548|147413187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.589||95.0|0.64|2.17||Two-sided significance level 5%|Cox Proportional Hazards Model|||Treatment groups are compared using a Cox Proportional Hazards model with treatment as factor and adjusting for age, Injury Severity Score (ISS), Glasgow Coma -Scale Score(GCS), International Normalized Ratio (INR) and acute lung injury.||2.17|0.64|0.589
73940638|NCT00184548|147413189|SUPERIORITY_OR_OTHER||LS means|0.9||||0.308||95.0|-0.83|2.63|||ANCOVA|||Baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma -Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury.||2.63|-0.83|0.308
73974174|NCT02720068|147492912|OTHER|Difference in Percentage|Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|-7.3|22.9|||||Confidence interval based on Miettinen \& Nurminen method|||22.9|-7.3|
73867409|NCT01122849|147279896|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.0815|TWO_SIDED|95.0|-0.68|0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.04|-0.68|0.0815
73867410|NCT01122849|147279896|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.0015|TWO_SIDED|95.0|0.24|0.94||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.94|0.24|0.0015
73867411|NCT01122849|147279896|SUPERIORITY_OR_OTHER||LS mean differnence|-1.03||||0.0292||95.0|-1.96|-0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||-0.11|-1.96|0.0292
73974175|NCT04227899|147492980|OTHER||||||<|0.0001|||||||One-sided Chi-square test|||||||<0.0001
73974176|NCT04227899|147492981|OTHER|||||||0.0019|||||||Farrington-Manning non-inferiority (NI)|||||||0.0019
73867412|NCT01122849|147279896|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.2497|TWO_SIDED|95.0|-0.39|1.47||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||1.47|-0.39|0.2497
73974177|NCT04227899|147492982|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73974178|NCT04227899|147492983|OTHER|||||||0.0081|||||||One-sided Chi-square test|||||||0.0081
73974179|NCT01046825|147492993|SUPERIORITY|||||||0.555|||||||Log Rank|||||||0.5550
73974180|NCT01046825|147492994|SUPERIORITY|||||||0.3605|||||||Log Rank|||||||0.3605
73974181|NCT01046825|147492995|SUPERIORITY|||||||0.6181|||||||Chi-squared|||||||0.6181
74031160|NCT01929044|147615859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0658|TWO_SIDED|95.0|-0.82|0.03|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.03|-0.82|0.0658
73867413|NCT01122849|147279896|SUPERIORITY_OR_OTHER||LS Mean difference|-1.57||||0.0011|TWO_SIDED|95.0|-2.48|-0.66||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||-0.66|-2.48|0.0011
73867414|NCT01122849|147279897|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.8063|TWO_SIDED|95.0|-0.4|0.51||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.51|-0.40|0.8063
73867415|NCT01122849|147279897|SUPERIORITY_OR_OTHER||LS Mean Differnence|-0.35||||0.1356|TWO_SIDED|95.0|-0.82|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.11|-0.82|0.1356
73867416|NCT01122849|147279897|SUPERIORITY_OR_OTHER||LS mean Difference|0.41||||0.0786|TWO_SIDED|95.0|-0.05|0.87|||ANCOVA|||Comparison for Q2 at Day 14||0.87|-0.05|0.0786
73940639|NCT00184548|147413191|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift estimate|1.0||||0.038||95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|0.038
73940640|NCT00184548|147413192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.175||||0.384||95.0|0.817|1.69|||Regression, Logistic|||||1.690|0.817|0.384
73940641|NCT00184548|147413193|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift estimate|2.0||||0.03||95.0|0.0|4.0|||Wilcoxon (Mann-Whitney)|||||4|0|0.030
73974182|NCT04664881|147493023|SUPERIORITY|||||||0.71|||||||Chi-squared, Corrected|||||||0.71
73940642|NCT02184611|147413198|OTHER||Least square mean difference|0.154|||<|0.001|TWO_SIDED|95.0|0.113|0.194||Analysis was performed using a MMRM model with covariates of treatment, Baseline, smoking status, country, Day, Day by Baseline and Day by treatment interactions.|Mixed Models Repeated Measures (MMRM)|||UMEC versus Placebo.||0.194|0.113|<0.001
73974183|NCT04664881|147493024|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||Cardiovascular Death||||0.99
73974184|NCT04664881|147493024|SUPERIORITY|||||||0.36|||||||Chi-squared, Corrected|||Hospitalization for Myocardial Infarction||||0.36
73974185|NCT04664881|147493024|SUPERIORITY|||||||0.13|||||||Chi-squared, Corrected|||Arrhythmias||||0.13
73974186|NCT04664881|147493024|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||Cardiac Arrest||||0.99
73974187|NCT04757753|147493029|NON_INFERIORITY|"πN = 2-year successful treatment rate of PA1704 πR = 2-year successful treatment rate of BioRoot™ RCS Δ = πN - πR ΔL = non-inferiority margin fixed to 13% or 0.13~Hypotheses are :~H0 : Δ ≤ -ΔL H1 : Δ \> -ΔL The χ2 of Dunnett \& Gent is used to assess the non-inferiority"|Mean Difference (Final Values)|0.006||||0.03|TWO_SIDED|90.0|-0.0074|0.0087||A priori threshold for statistical significance was \< 0.05|Chi-squared, Corrected|||The statistical analysis was done on the proportion difference of the treatment efficacy, defined on loose criteria, at 24 months, in PP population.||0.0087|-0.0074|0.03
73867417|NCT01122849|147279897|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.72||||0.1693|TWO_SIDED|95.0|-1.75|0.32||Between treatment p-values and confidence intervals|ANCOVA|||Comparisons for Q4 at Day 14||0.32|-1.75|0.1693
73867418|NCT01122849|147279897|SUPERIORITY_OR_OTHER||LS Mean difference|1.08||||0.0438|TWO_SIDED|95.0|0.03|2.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||2.13|0.03|0.0438
73867419|NCT01122849|147279897|SUPERIORITY_OR_OTHER||LS Mean difference|-1.8||||0.0009|TWO_SIDED|95.0|-2.82|-0.78||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||-0.78|-2.82|0.0009
73867420|NCT01122849|147279898|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24||||0.1991|TWO_SIDED|95.0|-0.62|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.13|-0.62|0.1991
73940643|NCT02184611|147413199|OTHER||Least square Mean difference|0.9||||0.004|TWO_SIDED|95.0|0.3|1.5||Analysis performed using a MMRM model with covariates of treatment, BDI focal score, smoking status, country, Day, Day by BDI focal score and Day by treatment interactions.|MMRM|||UMEC versus Placebo.||1.5|0.3|0.004
73974188|NCT00357682|147493040|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.24||||0.068|TWO_SIDED|95.0|0.98|1.57|||Accelerated Failure Time|||Accelerated Failure Time (AFT) analysis comparing time to primary event in low dose PPI (20mg) patients to high dose PPI (80mg) patients. Included in AFT model are stratification factors (Barrett's length, age group and presence of baseline intestinal metaplasia) and aspirin randomisation group.||1.57|0.98|0.068
73974189|NCT00357682|147493040|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.27||||0.037|TWO_SIDED|95.0|1.01|1.58|||Accelerated Failure Time|||Accelerated Failure Time (AFT) analysis comparing time to primary event in aspirin patients to non-aspirin patients. Included in AFT model are stratification factors (Barrett's length, age group and presence of baseline intestinal metaplasia) and PPI randomisation group.||1.58|1.01|0.037
73974190|NCT00357682|147493041|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.36||||0.039|TWO_SIDED|95.0|1.01|1.82|||Accelerated Failure Time|||All recordings of death, regardless of the cause are used in this analysis and both PPI groups are compared.||1.82|1.01|0.039
73974191|NCT00357682|147493041|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.25||||0.159|TWO_SIDED|95.0|0.92|1.7|||Accelerated Failure Time|||There are 163 deaths in the aspirin comparison with all-cause mortality as the endpoint. Median follow-up is 8.9 years IQR: (8.2 , 10.0) Range: (0 , 11.5)||1.70|0.92|0.159
73974192|NCT00357682|147493042|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.04||||0.864|TWO_SIDED|95.0|0.67|1.61|||Accelerated Failure Time|||There are 81 diagnoses in the PPI dose comparison with adenocarcinoma oesophageal cancer as the endpoint. Median follow-up is 8.7 years IQR: (8.1 , 9.9)||1.61|0.67|0.864
73974193|NCT00357682|147493042|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.02||||0.921|TWO_SIDED|95.0|0.64|1.64|||Accelerated Failure Time|||There are 70 diagnoses of adenocarcinoma in the aspirin comparison. Median follow-up is 8.8 years, IQR: (8.1 , 10), Range: (0 , 11.5)||1.64|0.64|0.921
73974194|NCT00357682|147493043|SUPERIORITY|5% significance level is considered statistically significant.|Time Ratio|1.36||||0.119|TWO_SIDED|95.0|0.92|2.02|||Accelerated Failure Time|||There are 103 such diagnoses in the PPI dose comparison. Median follow-up is 8.7 years IQR: (8.1 , 9.9) Range: (0 , 11.48)||2.02|0.92|0.119
73974195|NCT00357682|147493043|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.51||||0.053|TWO_SIDED|95.0|1.0|2.29|||Accelerated Failure Time|||There are a total of 92 conversions to HGD in the aspirin comparison. Median follow-up is 8.8 years IQR (8.1 , 10.0) Range (0 , 11.5)||2.29|1.00|0.053
73974196|NCT02701283|147493106|NON_INFERIORITY|Absolute non-inferiority margin was 0.06|Posterior Median of the Difference|0.999|||||TWO_SIDED|95.0||||The posterior probability of non-inferiority is \> 0.999. The posterior probability is the probability of the event rate by updating the prior probability distribution with observed data at the interim analysis using Bayes' Theorem.|Bayesian||95% Bayesian credible interval for the difference (TAVR-SAVR) was (-4.4%, 0.4%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.|Primary Hypothesis: TAVR with the Medtronic TAVR system is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months for the Randomized Controlled Trial||||
74089076|NCT03575871|147731430|SUPERIORITY||Difference in Percentage|5.1||||0.0459|TWO_SIDED|95.0|0.2|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.0|0.2|0.0459
74089077|NCT03575871|147731430|SUPERIORITY||Difference in Percentage|14.2||||0.0005|TWO_SIDED|95.0|7.8|20.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.5|7.8|0.0005
73867421|NCT01122849|147279898|SUPERIORITY_OR_OTHER||LS Mean difference|-0.21||||0.2964|TWO_SIDED|95.0|-0.6|0.19||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7||0.19|-0.60|0.2964
73867422|NCT01122849|147279898|SUPERIORITY_OR_OTHER||LS mean difference|-0.04||||0.8495|TWO_SIDED|95.0|-0.42|0.35||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7||0.35|-0.42|0.8495
73867423|NCT01122849|147279898|SUPERIORITY_OR_OTHER||LS mean difference|1.35||||0.0381|TWO_SIDED|95.0|0.08|2.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||2.62|0.08|0.0381
73940644|NCT02184611|147413200|OTHER||Least square Mean difference|0.125|||<|0.001|TWO_SIDED|95.0|0.103|0.147||Analysis performed using an analysis of covariance (ANCOVA) model with covariates of treatment, baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status and country.|ANCOVA|||UMEC versus Placebo.||0.147|0.103|<0.001
73867424|NCT01122849|147279898|SUPERIORITY_OR_OTHER||LS mean difference|0.54||||0.4005|TWO_SIDED|95.0|-0.74|1.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||1.82|-0.74|0.4005
73867425|NCT01122849|147279898|SUPERIORITY_OR_OTHER||LS mean difference|0.81||||0.202|TWO_SIDED|95.0|-0.45|2.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||2.07|-0.45|0.2020
73940645|NCT02184611|147413209|OTHER||Least sqaure mean difference|-4.39||||0.002|TWO_SIDED|95.0|-7.21|-1.58||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.||-1.58|-7.21|0.002
73940646|NCT02184611|147413209|OTHER||Least square mean difference|-4.59||||0.003|TWO_SIDED|95.0|-7.61|-1.57||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.||-1.57|-7.61|0.003
73974197|NCT04319887|147493132|OTHER||||||||||||||||||statistical analysis section may be deleted|||
73974198|NCT04079517|147493140|NON_INFERIORITY|Comparing mean difference in symptom score (95% confidence intervals). Post hoc analysis. Not powered, but to give an indication of differences between standard dose (20mg) and the non-approved dose (10mg).|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|||||||Post hoc analysis. Not powered, but to give an indication on differences in symptom score between standard dose (20mg) and the non-approved dose (10mg).||Post hoc analysis. Not powered, but to give an indication on differences between standard dose (20mg) and the non-approved dose (10mg).|||
74031161|NCT01929044|147615860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.2||0.022|TWO_SIDED|95.0|-0.85|-0.07|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||-0.07|-0.85|0.0220
74031162|NCT01929044|147615861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0149|TWO_SIDED|95.0|-0.81|-0.09|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||-0.09|-0.81|0.0149
74031163|NCT01929044|147615862|SUPERIORITY_OR_OTHER|||||||0.0113|||||||van Elteren test|The van Elteren test stratifying for centre (Cochran-Mantel-Haenszel test using modified ridit scores) was performed.||||||0.0113
74031164|NCT01929044|147615863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.0992|TWO_SIDED|95.0|0.37|1.09|||Regression, Logistic|A logistic regression model was used to evaluate the response with treatment as fixed effect and baseline pain intensity as continuous covariate.|Exact 95% confidence interval obtained by Clopper and Pearson approach.|||1.09|0.37|0.0992
74031165|NCT01605396|147615868|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.565|TWO_SIDED|80.0|0.81|1.72|||Regression, Cox|||Hazard ratio (HR) and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).||1.72|0.81|0.565
74031166|NCT01605396|147615870|OTHER||Difference of Percentages|-10.0||||0.267|TWO_SIDED|95.0|-27.8|8.0|||Miettinen and Nurminen's Method|||Miettinen and Nurminen's method was used to compare ORR between the two treatment arms (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm), and to calculate a p-value and 95% confidence interval (CI) for the difference in response rates.||8.0|-27.8|0.267
73974199|NCT04518943|147493181|SUPERIORITY||Mean Difference (Net)|-634.0||||0.418|TWO_SIDED|90.0|-1924.0|655.0|||linear mixed model|||This is the results of financial vs non-financial reward factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignment, linear week with a spline at week 12, and interactions between factors and weeks.||655|-1924|0.418
73974200|NCT04518943|147493181|SUPERIORITY||Mean Difference (Net)|-1697.0||||0.033|TWO_SIDED|90.0|-3000.0|-385.0|||Mixed Models Analysis||Positive values represent a positive effect of lottery based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||-385|-3000|0.033
73974201|NCT04518943|147493181|SUPERIORITY||Mean Difference (Net)|820.0||||0.248|TWO_SIDED|90.0|-347.0|1988.0|||Mixed Models Analysis|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive a request for PC compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1988|-347|0.248
74031167|NCT01605396|147615871|OTHER||Hazard Ratio (HR)|1.38||||0.562|TWO_SIDED|95.0|0.46|4.13|||Regression, Cox|||HR and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).||4.13|0.46|0.562
74039422|NCT04847141|147632417|SUPERIORITY||Difference in Percentage|3.0||||0.4676|TWO_SIDED|95.0|-5.3|11.5||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required at least 1 COVID-19 related MAV between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||11.5|-5.3|0.4676
73940647|NCT02184611|147413209|OTHER||Least sqaure mean difference|-3.03||||0.058|TWO_SIDED|95.0|-6.15|0.1||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 168, UMEC Vs Placebo.||0.10|-6.15|0.058
73867426|NCT01122849|147279899|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09||||0.5741|TWO_SIDED|95.0|-0.41|0.23||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.23|-0.41|0.5741
73867427|NCT01122849|147279899|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.6935|TWO_SIDED|95.0|-0.26|0.39||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.39|-0.26|0.6935
73867428|NCT01122849|147279899|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.333|TWO_SIDED|95.0|-0.47|0.16||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q2 at Day 14||0.16|-0.47|0.3330
73940648|NCT02184611|147413210|OTHER||Least sqaure mean difference|-1.49||||0.027|TWO_SIDED|95.0|-2.81|-0.17||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.||-0.17|-2.81|0.027
73867429|NCT01122849|147279899|SUPERIORITY_OR_OTHER||LS Mean difference|1.39||||0.0434|TWO_SIDED|95.0|0.04|2.73||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||2.73|0.04|0.0434
73940649|NCT02184611|147413210|OTHER||Least square mean difference|-2.1||||0.004|TWO_SIDED|95.0|-3.51|-0.68||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.||-0.68|-3.51|0.004
73940650|NCT02184611|147413210|OTHER||Least square mean difference|-0.68||||0.386|TWO_SIDED|95.0|-2.22|0.86||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 128, UMEC Vs Placebo.||0.86|-2.22|0.386
73940651|NCT00985725|147413222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0||||0.0009|TWO_SIDED|95.0|-12.7|-3.3|||ANCOVA|||||-3.3|-12.7|0.0009
73940652|NCT00985725|147413223|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0465|TWO_SIDED|95.0|-3.7|0.0|||ANCOVA|||||0.0|-3.7|0.0465
73940653|NCT00985725|147413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.1||||0.0181|TWO_SIDED|95.0|-9.4|-0.9|||ANCOVA|||Behavioral recognition index||-0.9|-9.4|0.0181
73974202|NCT04518943|147493181|SUPERIORITY||Mean Difference (Net)|1121.0||||0.125|TWO_SIDED|90.0|82.0|2323.0|||Mixed Models Analysis|||This is the results of advice vs no advice factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.|Positive values represent a positive effect of requests for advice on steps compared to no request for advice.|2323|82|0.125
74008995|NCT01540825|147568695|SUPERIORITY_OR_OTHER||Slope|1.1626|STANDARD_ERROR_OF_MEAN|0.0215|||TWO_SIDED|95.0|1.1195|1.2057|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (PIB) for AUC 0- tz was analysed.||1.2057|1.1195|
73867430|NCT01122849|147279899|SUPERIORITY_OR_OTHER||LS Mean difference|0.32||||0.6333|TWO_SIDED|95.0|-1.02|1.67||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||1.67|-1.02|0.6333
73867431|NCT01122849|147279899|SUPERIORITY_OR_OTHER||LS mean difference|1.06||||0.1091|TWO_SIDED|95.0|-0.25|2.37||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Q4 at Day 14||2.37|-0.25|0.1091
73867432|NCT03997825|147279915|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
73940654|NCT00985725|147413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2||||0.0204|TWO_SIDED|95.0|-7.7|-0.7|||ANCOVA|||Inhibit subscale||-0.7|-7.7|0.0204
73940655|NCT00985725|147413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6||||0.009|TWO_SIDED|95.0|-9.8|-1.4|||ANCOVA|||Shift subscale||-1.4|-9.8|0.0090
73940656|NCT00985725|147413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.0793|TWO_SIDED|95.0|-7.9|0.4|||ANCOVA|||Emotional control subscale||0.4|-7.9|0.0793
73940657|NCT00985725|147413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.1014|TWO_SIDED|95.0|-7.0|0.6|||ANCOVA|||Self-monitor subscale||0.6|-7.0|0.1014
73940658|NCT00985725|147413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0||||0.0002|TWO_SIDED|95.0|-13.7|-4.3|||ANCOVA|||Metacognition index||-4.3|-13.7|0.0002
73867433|NCT03997825|147279916|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
73940659|NCT00985725|147413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.6||||0.0002|TWO_SIDED|95.0|-12.9|-4.2|||ANCOVA|||Initiate subscale||-4.2|-12.9|0.0002
73940660|NCT00985725|147413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.1||||0.0001|TWO_SIDED|95.0|-13.7|-4.5|||ANCOVA|||Working memory subscale||-4.5|-13.7|0.0001
73940661|NCT00985725|147413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.5||||0.001|TWO_SIDED|95.0|-11.9|-3.1|||ANCOVA|||Plan/Organize subscale||-3.1|-11.9|0.0010
73940662|NCT00985725|147413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0357|TWO_SIDED|95.0|-9.4|-0.3|||ANCOVA|||Task monitor subscale||-0.3|-9.4|0.0357
73940663|NCT00985725|147413224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0||||0.0012|TWO_SIDED|95.0|-11.1|-2.8|||ANCOVA|||Organization of materials subscale||-2.8|-11.1|0.0012
73940664|NCT00985725|147413229|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.1731|TWO_SIDED|95.0|-10.9|2.0|||ANCOVA|||||2.0|-10.9|0.1731
73940665|NCT03563716|147413237|SUPERIORITY||Odds Ratio (OR)|2.57|||||TWO_SIDED|95.0|1.07|6.14|||||95% CI for odds ratio was constructed using the Wald method.|Stratified analysis based on PD-L1 immunohistochemistry (IHC) 22C3 pharmDx, tumor histology status, and tobacco history.||6.14|1.07|
73940666|NCT03563716|147413238|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.37|0.9|||||Hazard ratios were estimated by Cox regression.|Stratified analysis based on PD-L1 IHC 22C3 pharmDx, tumor histology status, and tobacco history.||0.90|0.37|
73940667|NCT03595579|147413245|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73940668|NCT03595579|147413246|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
73867434|NCT00383162|147279921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|||<|0.001||95.0|2.17|9.36|||Generalized Estimating Equations|||||9.36|2.17|<0.001
73867435|NCT00767819|147279940|SUPERIORITY|The lower limit of the confidence interval was used to support the decision in favor of p0 or p1: if the lower limit of the confidence interval overlapped p0, the hypothesis that p is greater than or equal to p1 could be rejected; on the other side, if the lower limit of the confidence interval excluded p0, the hypothesis that p is greater than or equal to p1 could be accepted.|percentage of participants|40.5||||0.1|TWO_SIDED|80.0|29.5|52.4|||Clopper-Person confidence interval|||||52.4|29.5|0.1
73867436|NCT02726022|147279947|SUPERIORITY_OR_OTHER|||||||0.647|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.647
73867437|NCT02726022|147279947|SUPERIORITY_OR_OTHER|||||||0.373|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.373
73867438|NCT02726022|147279948|SUPERIORITY_OR_OTHER|||||||0.049|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.049
73867439|NCT02726022|147279948|SUPERIORITY_OR_OTHER|||||||0.86|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.860
73867440|NCT02726022|147279949|SUPERIORITY_OR_OTHER|||||||0.921|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.921
73867441|NCT02726022|147279949|SUPERIORITY_OR_OTHER|||||||0.962|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.962
73867442|NCT02726022|147279950|SUPERIORITY_OR_OTHER|||||||0.052|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.052
73867443|NCT02726022|147279950|SUPERIORITY_OR_OTHER|||||||0.677|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.677
73940669|NCT00483184|147413252|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||ANOVA|||Results were expressed as mean or number. Normal distributed data among the treatment groups were compared by One-way ANOVA test, non-normal distributed data were compared by Kruskal Wallis test, and then Bonferroni post-hoc test was used for multiple comparisons. Differences from baseline within treatment groups were evaluated by repeated measures ANOVA test for normal distributed data, Freidman test for non-normal distributed data.||||0.404
73940670|NCT00558428|147413254|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001||95.0|-4.9|-2.38|||ANCOVA|Adjusted for baseline and country effect||||-2.38|-4.90|<0.0001
73974203|NCT04518943|147493182|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.53||0.739|TWO_SIDED|90.0|-1.05|0.7|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares change in efficacy from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.|Positive values represent a positive effect of financial rewards compared to non-financial rewards.|0.70|-1.05|0.739
73867444|NCT02726022|147279951|SUPERIORITY_OR_OTHER|||||||0.72|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.720
73867445|NCT02726022|147279951|SUPERIORITY_OR_OTHER|||||||0.237|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.237
73867446|NCT02726022|147279952|SUPERIORITY_OR_OTHER|||||||0.184|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.184
73867447|NCT02726022|147279952|SUPERIORITY_OR_OTHER|||||||0.889|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.889
73867448|NCT00915551|147279953|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73867449|NCT00915551|147279954|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73867450|NCT00235716|147279955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.15||||0.03|TWO_SIDED|95.0|0.92|5.39||p-value adjusted for 6 treatment group comparisons.|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||5.39|0.92|0.03
73867451|NCT00235716|147279955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.98||||0.4|TWO_SIDED|95.0|-0.24|4.2||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||4.20|-0.24|0.40
73940671|NCT00558428|147413254|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.92|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001||95.0|-6.18|-3.66|||ANCOVA|Adjusted for baseline and country effect||||-3.66|-6.18|<0.0001
73940672|NCT00558428|147413254|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-2.66|-0.14|||ANCOVA|Adjusted for baseline and country effect||||-0.14|-2.66|
73940673|NCT00558428|147413254|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-3.93|-1.43|||ANCOVA|Adjusted for baseline and country effect||||-1.43|-3.93|
73940674|NCT05224050|147413269|OTHER|A paired-samples t-test was conducted to examine differences in the DASS-21 total score from baseline to 2-weeks post-quit.|Mean Difference (Final Values)|-2.04|STANDARD_DEVIATION|10.54||0.4|TWO_SIDED|95.0|-6.98|2.89||The threshold for statistical significance was p\<0.05|t-test, 2 sided||Mean difference represents the difference of the mean for the DASS-21 total scores at Baseline and at 2-weeks post-quit. The reported estimated value is based on data from the n=20 who attended their 2-weeks post-quit session|||2.89|-6.98|0.40
73940675|NCT05224050|147413269|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 2-weeks post-quit to 1-month post-quit.|Mean Difference (Final Values)|-2.43|STANDARD_DEVIATION|9.15||0.26|TWO_SIDED|95.0|-6.84|1.98||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at 2-weeks post-quit and 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session.|||1.98|-6.84|0.26
73940676|NCT05224050|147413269|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 1-month post-quit to 3-month follow up.|Mean Difference (Final Values)|-2.75|STANDARD_DEVIATION|6.49||0.11|TWO_SIDED|95.0|-6.21|0.71||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at 1-month post-quit and 3-month follow up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow up session.|||0.71|-6.21|0.11
73940677|NCT05224050|147413272|OTHER|A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline to Quit Day.|Mean Difference (Final Values)|13.7|STANDARD_DEVIATION|8.63|<|0.001|TWO_SIDED|95.0|9.88|17.53||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from Baseline to Quit Date. The reported estimated value is based on data from the n=22 participants who attended their Quit Date session.|||17.53|9.88|<0.001
73940678|NCT05224050|147413272|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from Quit Date to 2-weeks Post-Quit.|Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|2.02||0.8|TWO_SIDED|95.0|-0.83|1.06||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from Quit Date to 2-weeks Post-Quit. The reported estimated value is based on data from the n=20 participants who attended their 2-weeks post-quit session.|||1.06|-0.83|0.80
73940679|NCT05224050|147413272|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from 2-weeks post-quit to 1=month post-quit.|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.97||0.97|TWO_SIDED|95.0|-1.41|1.45||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from 2-weeks post-quit to 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session.|||1.45|-1.41|0.97
73940680|NCT05224050|147413272|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from 1-month post-quit to 3-month follow-up.|Mean Difference (Final Values)|-2.17|STANDARD_DEVIATION|3.75||0.04|TWO_SIDED|95.0|-4.17|-0.17||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from 1-month post-quit to 3-month follow-up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow-up session.|||-0.17|-4.17|0.04
73940681|NCT01137474|147413273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|0.9251||0.001|TWO_SIDED|95.0|-4.87|-1.24||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis. With 253 patients per group, there is \>80% power to detect a difference of 3.5 mm Hg at alpha=0.05, assuming a common SD of 14 mm Hg.||-1.24|-4.87|0.0010
73940682|NCT01137474|147413274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.0673|<|0.0001|TWO_SIDED|95.0|-0.59|-0.33||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in the double-blind treatment period were included in the longitudinal repeated measures model||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. With 253 subjects per group, there is \>98% power to detect a difference of 0.4% at a=0.05, assuming a common SD of 1.1%.||-0.33|-0.59|<0.0001
73940683|NCT01137474|147413275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.89|STANDARD_ERROR_OF_MEAN|1.0091||0.0043|TWO_SIDED|95.0|-4.88|-0.91||Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|ANCOVA|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.||-0.91|-4.88|0.0043
73867452|NCT00235716|147279955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.76||||0.49|TWO_SIDED|95.0|-0.48|4.0||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||4.00|-0.48|0.49
73867453|NCT00235716|147279955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39||||0.6|TWO_SIDED|95.0|-3.63|0.85||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.85|-3.63|0.60
73867454|NCT00235716|147279955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.85|TWO_SIDED|95.0|-2.44|2.01||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||2.01|-2.44|0.85
73867455|NCT00235716|147279955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.6|TWO_SIDED|95.0|-1.04|3.39||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.39|-1.04|0.60
73867456|NCT00235716|147279956|SUPERIORITY_OR_OTHER|||||||0.69||||||p- value is unadjusted for multiple comparisons because its a 3 degrees of freedom test for any treatment group differences|Log Rank|3 degrees of freedom test||||||0.69
73867457|NCT00235716|147279957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.84|TWO_SIDED|95.0|-0.54|0.92||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.92|-0.54|0.84
73867458|NCT00235716|147279957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.84|TWO_SIDED|95.0|-0.61|0.84||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.84|-0.61|0.84
73940684|NCT01137474|147413276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.5811||0.0843|TWO_SIDED|95.0|-2.15|0.14||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis.||0.14|-2.15|0.0843
73940685|NCT01137474|147413277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.6866|||TWO_SIDED|95.0|-1.96|0.73||Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.|ANCOVA|||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.||0.73|-1.96|
73940686|NCT01137474|147413278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.0717|||TWO_SIDED|95.0|-0.46|-0.18||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction.||-0.18|-0.46|
73940687|NCT02219048|147413281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0719|STANDARD_ERROR_OF_MEAN|0.0909|||TWO_SIDED|90.0|-0.2243|0.0805|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 1||0.0805|-0.2243|
74008996|NCT01540825|147568696|SUPERIORITY_OR_OTHER||Slope|1.151|STANDARD_ERROR_OF_MEAN|0.0215|||TWO_SIDED|95.0|1.108|1.1941|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose).Dose proportionality of BI 113608 (PIB) for AUC0-inf was analysed||1.1941|1.1080|
73974204|NCT04518943|147493182|SUPERIORITY||Mean Difference (Net)|-0.51||||0.347|TWO_SIDED|90.0|-1.42|0.39|||Mixed Models Analysis||Positive values represent a positive effect of financial rewards compared to non-financial rewards.|This is the results of financial vs non-financial reward factor at week 24. It compares change in efficacy from baseline to week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.39|-1.42|0.347
73940688|NCT02219048|147413281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.092|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|90.0|-0.2362|0.0523|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 2||0.0523|-0.2362|
73974205|NCT04518943|147493182|SUPERIORITY||Mean Difference (Net)|0.61||||0.293|TWO_SIDED|90.0|-0.35|1.57|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 12. It compares change in efficacy from baseline to week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.57|-0.35|0.293
74008997|NCT01641237|147568702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %SMHR as a function of fluoride concentration.||||<0.0001
73940689|NCT02219048|147413281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1131|STANDARD_ERROR_OF_MEAN|0.0837|||TWO_SIDED|90.0|-0.2536|0.0274|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 3||0.0274|-0.2536|
73940690|NCT02219048|147413281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.058|STANDARD_ERROR_OF_MEAN|0.0829|||TWO_SIDED|90.0|-0.1971|0.0812|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 4||0.0812|-0.1971|
73940691|NCT02219048|147413281|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.0837|STANDARD_ERROR_OF_MEAN|0.0742|||TWO_SIDED|90.0|-0.2081|0.0406|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline Over Week 1 to 4||0.0406|-0.2081|
73940692|NCT02219048|147413284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|90.0|-0.285|0.106|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline Averaged Over Week 1 to 4||0.106|-0.285|
73940693|NCT02219048|147413286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.017|STANDARD_ERROR_OF_MEAN|10.003|||TWO_SIDED|90.0|-10.76|22.794|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 1||22.794|-10.760|
73940694|NCT02219048|147413286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.591|STANDARD_ERROR_OF_MEAN|12.228|||TWO_SIDED|90.0|-13.926|27.108|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 2||27.108|-13.926|
73940695|NCT02219048|147413286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.954|STANDARD_ERROR_OF_MEAN|11.673|||TWO_SIDED|90.0|-18.644|20.552|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 3||20.552|-18.644|
73940696|NCT02219048|147413286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.368|STANDARD_ERROR_OF_MEAN|12.92|||TWO_SIDED|90.0|-26.069|17.333|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 4||17.333|-26.069|
73940697|NCT02219048|147413286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.299|STANDARD_ERROR_OF_MEAN|10.503|||TWO_SIDED|90.0|-15.323|19.92|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB Averaged Over 4 Weeks||19.920|-15.323|
73940698|NCT02219048|147413286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.135|STANDARD_ERROR_OF_MEAN|10.961|||TWO_SIDED|90.0|-17.248|19.519|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 1||19.519|-17.248|
74039423|NCT04847141|147632417|SUPERIORITY||Difference in Percentage|4.9||||0.2507|TWO_SIDED|95.0|-3.6|13.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required at least 1 COVID-19 related MAV between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||13.4|-3.6|0.2507
74089078|NCT03575871|147731430|SUPERIORITY||Difference in Percentage|12.9||||0.0019|TWO_SIDED|95.0|6.3|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.3|0.0019
74089079|NCT03575871|147731430|SUPERIORITY||Difference in Percentage|31.8|||<|0.0001|TWO_SIDED|95.0|23.6|39.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.9|23.6|<0.0001
73867459|NCT00235716|147279957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37||||0.84|TWO_SIDED|95.0|-0.36|1.1||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.10|-0.36|0.84
73940699|NCT02219048|147413286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.834|STANDARD_ERROR_OF_MEAN|9.956|||TWO_SIDED|90.0|-13.871|19.54|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 2||19.540|-13.871|
73940700|NCT02219048|147413286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.374|STANDARD_ERROR_OF_MEAN|11.652|||TWO_SIDED|90.0|-27.933|11.185|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 3||11.185|-27.933|
73940701|NCT02219048|147413286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.445|STANDARD_ERROR_OF_MEAN|13.573|||TWO_SIDED|90.0|-23.245|22.356|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 4||22.356|-23.245|
73940702|NCT02219048|147413286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.212|STANDARD_ERROR_OF_MEAN|10.317|||TWO_SIDED|90.0|-18.52|16.096|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB Averaged Over 4 Weeks||16.096|-18.520|
73940703|NCT02275065|147413301|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940704|NCT02275065|147413301|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940705|NCT02275065|147413301|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940706|NCT02275065|147413301|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940707|NCT02275065|147413304|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940708|NCT02275065|147413304|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940709|NCT02275065|147413304|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940710|NCT02275065|147413304|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940711|NCT02275065|147413305|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940712|NCT02275065|147413305|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940713|NCT02275065|147413305|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940714|NCT02275065|147413305|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
73940715|NCT00518115|147413322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.2968|TWO_SIDED|95.0|-0.18|0.59|||ANCOVA|||||0.59|-0.18|0.2968
73940716|NCT00518115|147413322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.186|TWO_SIDED|95.0|-0.64|0.12|||ANCOVA|||||0.12|-0.64|0.1860
73940717|NCT00518115|147413322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0027|TWO_SIDED|95.0|-1.03|-0.22|||ANCOVA|||||-0.22|-1.03|0.0027
73940718|NCT00518115|147413322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.2766|TWO_SIDED|95.0|-0.62|0.18|||ANCOVA|||||0.18|-0.62|0.2766
73940719|NCT00518115|147413322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0057|TWO_SIDED|95.0|-0.94|-0.16|||ANCOVA|||||-0.16|-0.94|0.0057
73867460|NCT00235716|147279957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.84||95.0|-0.56|0.9||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.90|-0.56|0.84
73867461|NCT00235716|147279957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.84|TWO_SIDED|95.0|-0.47|0.98||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.98|-0.47|0.84
73940720|NCT00518115|147413322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0032|TWO_SIDED|95.0|-0.96|-0.19|||ANCOVA|||||-0.19|-0.96|0.0032
73940721|NCT00518115|147413322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0786|TWO_SIDED|95.0|-0.72|0.04|||ANCOVA|||||0.04|-0.72|0.0786
73940722|NCT00518115|147413322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0022|TWO_SIDED|95.0|-0.99|-0.22|||ANCOVA|||||-0.22|-0.99|0.0022
73940723|NCT04891419|147413341|SUPERIORITY||Rate Difference|91.1|||<|0.0001|TWO_SIDED|95.0|83.7|95.9||P-value is based on the Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||95.9|83.7|<.0001
73940724|NCT04891419|147413342|SUPERIORITY||Control Difference|54.5|STANDARD_ERROR_OF_MEAN|2.69|<|0.0001|TWO_SIDED|95.0|49.2|59.9||P-value estimated using mixed effects model.|Mixed Models Analysis||95% CI estimated using mixed effects model.|||59.9|49.2|<.0001
73940725|NCT04891419|147413343|SUPERIORITY||Control Difference|42.8|STANDARD_ERROR_OF_MEAN|2.63|<|0.0001|TWO_SIDED|95.0|37.6|48.0||95% CI and p-value estimated using mixed effects model.|Mixed Models Analysis|||||48.0|37.6|<.0001
73940726|NCT04891419|147413344|SUPERIORITY||Rate Difference|93.1|||<|0.0001|TWO_SIDED|95.0|86.1|97.2||P-value is based on Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||97.2|86.1|<.0001
73940727|NCT04891419|147413345|SUPERIORITY||Rate Difference|92.1|||<|0.0001|TWO_SIDED|95.0|84.9|96.5||P-value is based on Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||96.5|84.9|<.0001
73940728|NCT00827918|147413346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.859|TWO_SIDED|95.0|-7.0|5.8|||Difference in the Least Squares Mean|||||5.8|-7.0|0.8590
73940729|NCT00827918|147413346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.2534|TWO_SIDED|95.0|-11.7|3.1|||Difference in the Least Squares Mean|||||3.1|-11.7|0.2534
73940730|NCT00827918|147413349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.4976|TWO_SIDED|95.0|0.62|2.64|||Generalized linear mixed analysis model|||||2.64|0.62|0.4976
73940731|NCT00827918|147413349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0653|TWO_SIDED|95.0|0.95|5.09|||Generalized linear mixed analysis model|||||5.09|0.95|0.0653
73940732|NCT00827918|147413350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8199|TWO_SIDED|95.0|-0.4|0.3|||Constrained longitudinal data analysis|||||0.3|-0.4|0.8199
73940733|NCT00827918|147413350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9486|TWO_SIDED|95.0|-0.4|0.4|||Constrained longitudinal data analysis|||||0.4|-0.4|0.9486
73940734|NCT00827918|147413351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9937|TWO_SIDED|95.0|-2.0|2.0|||Constrained longitudinal data analysis|||||2.0|-2.0|0.9937
73940735|NCT00827918|147413351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.2406|TWO_SIDED|95.0|-3.6|0.9|||Constrained longitudinal data analysis|||||0.9|-3.6|0.2406
73940736|NCT00827918|147413352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.5953|TWO_SIDED|95.0|-2.0|1.2|||Constrained longitudinal data analysis|||||1.2|-2.0|0.5953
73940737|NCT00827918|147413352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8567|TWO_SIDED|95.0|-2.0|1.6|||Constrained longitudinal data analysis|||||1.6|-2.0|0.8567
73940738|NCT00374322|147413385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.286|TWO_SIDED|95.0|0.77|1.08||The p-value was calculated from a stratified log-rank test, stratifying for hormone receptor status, time since initial diagnosis, and lymph node involvement.|Log Rank||Estimate of the treatment hazard ratio (HR) was calcuated using the pike estimator.|||1.08|0.77|0.286
73940739|NCT00829387|147413401|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.39||||0.47|TWO_SIDED|95.0|-1.47|0.69|||Linear mixed model|||||0.69|-1.47|0.47
73940740|NCT00829387|147413402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.4|TWO_SIDED|95.0|-1.15|0.47|||linear mixed model|||baseline to 36 weeks post-baseline||0.47|-1.15|0.40
73940741|NCT00829387|147413403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.31|TWO_SIDED|95.0|-7.02|2.32|||Linear mixed model|||baseline to 12 weeks post-baseline||2.32|-7.02|0.31
73940742|NCT00829387|147413404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-1.03|1.06|||linear mixed model|||baseline to 12 weeks comparison||1.06|-1.03|0.98
73940743|NCT00829387|147413405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.03|TWO_SIDED|95.0|-1.76|-0.07|||linear mixed model|||baseline to 36 weeks post-baseline||-0.07|-1.76|0.03
73940744|NCT00829387|147413406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.16||||0.15|TWO_SIDED|95.0|-9.86|1.55|||linear mixed model|||baseline to 36 weeks post-baseline||1.55|-9.86|0.15
74008998|NCT01641237|147568702|SUPERIORITY_OR_OTHER|||||||0.3748||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for %SMHR as a function of fluoride concentration.||||0.3748
73940745|NCT00707031|147413407|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval of the difference between lixisenatide and exenatide on mITT population was \<=0.4%.|Least squares (LS) mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|95.0|0.033|0.297||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), BMI (\<30, \>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate.||||To detect that upper confidence limit of 2-sided 95% confidence interval for least square (LS) mean difference between the 2 arms do not exceed 0.4% HbA1c, 300 patients per group would provide 96% power assuming a standard deviation of 1.3 and true difference in HbA1c between the 2 arms as 0.||0.297|0.033|
73940746|NCT01420848|147413455|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||It was used the Post Hoc and the statistical significance was p\<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups.||||0.006
73974206|NCT04518943|147493182|SUPERIORITY||Mean Difference (Net)|0.31||||0.599|TWO_SIDED|90.0|-0.67|1.3|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 24. It compares efficacy at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.30|-0.67|0.599
73974207|NCT04518943|147493182|SUPERIORITY||Mean Difference (Net)|1.49||||0.007|TWO_SIDED|90.0|0.58|2.4|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares efficacy at week 12 between subjects randomized to receive a request for PC to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.40|0.58|0.007
73974208|NCT04518943|147493182|SUPERIORITY||Mean Difference (Net)|1.78||||0.002|TWO_SIDED|90.0|0.86|2.7|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for PC compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.70|0.86|0.002
73974209|NCT04518943|147493182|SUPERIORITY||Mean Difference (Net)|1.02||||0.068|TWO_SIDED|90.0|0.1|1.94|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares efficacy at week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.94|0.10|0.068
73974210|NCT04518943|147493182|SUPERIORITY||Mean Difference (Net)|0.19||||0.74|TWO_SIDED|90.0|-0.76|1.14|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.14|-0.76|0.740
73974211|NCT04518943|147493183|SUPERIORITY||Mean Difference (Net)|0.14||||0.481|TWO_SIDED|90.0|-0.19|0.47|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares intrinsic motivation in week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator..||0.47|-0.19|0.481
73974212|NCT04518943|147493183|SUPERIORITY||Mean Difference (Net)|0.18||||0.388|TWO_SIDED|90.0|-0.16|0.52|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 24. It compares intrinsic motivation in week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.52|-0.16|0.388
73974213|NCT04518943|147493183|SUPERIORITY||Mean Difference (Net)|-0.02||||0.926|TWO_SIDED|90.0|-0.38|0.34|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.34|-0.38|0.926
74039424|NCT04847141|147632418|SUPERIORITY||Difference in Percentage|0.1||||0.9744|TWO_SIDED|95.0|-3.8|4.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required hospital admission between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||4.0|-3.8|0.9744
74031168|NCT01254604|147615882|NON_INFERIORITY_OR_EQUIVALENCE|The study was planned to enroll 248 subjects (124 per treatment group) to yield approximately 230 evaluable subjects (115 per treatment group). The study had power of 90% to test the primary hypothesis. The power and sample size were based on the following assumptions for treatment difference in change from baseline in IOP at Week 4: α = 0.025 (1-sided), Non-inferiority margin = 1.5 mmHg, True treatment difference = 0 mmHg, Standard deviation = 3.5 mmHg.|Difference in Least Squares Means|-1.7|||||TWO_SIDED|95.0|-2.6|-0.7|||ANCOVA|Analysis model includes terms for treatment, baseline IOP and ocular diagnosis (open-angle glaucoma or ocular hypertension)|Difference is tafluprost - timolol|The study hypothesis was that tafluprost is non-inferior to timolol with respect to change from baseline in diurnal IOP at Week 4 in participants with open-angle glaucoma or ocular hypertension. The study hypothesis would be met if the upper bound of the two-sided 95% confidence interval for the between-treatment difference in mean diurnal IOP change from baseline at Week4 (tafluprost - timolol) was ≤1.5 mmHg.||-0.7|-2.6|
74031169|NCT01254604|147615883|SUPERIORITY_OR_OTHER||Difference in percentage|19.5|||||TWO_SIDED|95.0|5.7|33.4|||Stratified Miettinen and Nurminen method|Participants were stratified by baseline IOP (\<26 mmHg or ≥26 mmHg at 0800 hours) and ocular diagnosis (open-angle glaucoma or ocular hypertension)|Between-group difference in percentage of participants with ≥25% reduction in IOP at Week 4 = percentage (tafluprost) - percentage (timolol)|||33.4|5.7|
73940747|NCT01420848|147413455|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||The statistical significance was p\<0.05.|ANOVA|||"It was verified the normality of data distribution and the homogeneity of variance.~It was carried out the analysis of variance (ANOVA) among the groups at the follow-up (after 15 days)."||||0.023
73940748|NCT01420848|147413456|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||After ANOVA it was performed Post Hoc Test and the statistical significance was p\<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA)of the medium difference among the groups in the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups (State Anxiety)||||0.012
73940749|NCT01420848|147413456|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||After ANOVA, the Post Hoc Test was done and the statistical significance was p\<0.05.|ANOVA|||"It was carried out the analysis of variance (ANOVA) of the medium difference among the groups at the follow-up (after 15 days).~Hypothesis: there is at least one difference among the groups (State Anxiety)."||||0.005
73940750|NCT04154787|147413500|SUPERIORITY|Comparison of adjusted geometric mean ratios on Day 169|Adjusted geometric mean ratio|1.37||||0.267|TWO_SIDED|95.0|0.9|2.08||Calculated at one-sided 10% level from a lower-tailed test|Mixed Models Analysis|||||2.08|0.90|0.2670
73940751|NCT04154787|147413503|SUPERIORITY||Adjusted geometric mean ratios|0.81||||0.4598|TWO_SIDED|95.0|0.47|1.42||Calculated from a two-sided test at the 0.05 significance level|Mixed Model for Repeated Measures||Comparison of adjusted geometric mean ratios: Test vs Ref.|Day 15||1.42|0.47|0.4598
73940752|NCT04154787|147413503|SUPERIORITY||Geometric mean ratios|1.3||||0.4528|TWO_SIDED|95.0|0.65|2.61||Calculated from a two-sided test at the 0.05 significance level|Mixed Model for Repeated Measures||Comparison of adjusted geometric mean ratios: Test vs Ref.|Day 169||2.61|0.65|0.4528
73940753|NCT01951625|147413511|OTHER||Log-Scale mean difference|-0.122|||=|0.1506|TWO_SIDED|90.0|-0.32|0.07|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups (BAY1021189 2.5mg, BAY1021189 2.5 to 5mg, BAY1021189 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test at the significance level of 5 percent (%). Results are reported including 90% confidence intervals (CI) for the difference of means. The difference between the pooled treatment group and the placebo group is difference of means on the log scale.||0.07|-0.32|= 0.1506
73940754|NCT01951625|147413511|OTHER||Log-Scale mean difference|-0.2494|||=|0.0483|TWO_SIDED|90.0|-0.5|0.0|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0|-0.5|= 0.0483
73940755|NCT01951625|147413511|OTHER||Log-Scale mean difference|-0.0731|||=|0.3042|TWO_SIDED|90.0|-0.31|0.16|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0.16|-0.31|= 0.3042
73940756|NCT01951625|147413511|OTHER||Log-Scale mean difference|-0.0396|||=|0.3841|TWO_SIDED|90.0|-0.26|0.18|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0.18|-0.26|= 0.3841
73940757|NCT01951625|147413511|OTHER||Log-Scale mean difference|0.0151|||=|0.5444|TWO_SIDED|90.0|-0.21|0.24|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only.||0.24|-0.21|= 0.5444
73940758|NCT03053050|147413527|SUPERIORITY||Percentage Difference|-2.1||||0.4941|TWO_SIDED|95.0|-8.3|4.0||Difference between SEL 18 mg and Placebo, 95% confidence interval (CI) and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and Enhanced Liver Fibrosis (ELF) test score as stratification factors.|Mantel Haenszel|||||4.0|-8.3|0.4941
73940759|NCT03053050|147413527|SUPERIORITY||Percentage Difference|-0.3||||0.9321|TWO_SIDED|95.0|-6.6|6.0||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||6.0|-6.6|0.9321
73940760|NCT03053050|147413529|SUPERIORITY||Percentage Difference|-4.0||||0.2593|TWO_SIDED|95.0|-10.8|2.9||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||2.9|-10.8|0.2593
73940761|NCT03053050|147413529|SUPERIORITY||Percentage Difference|-0.9||||0.808|TWO_SIDED|95.0|-7.9|6.1||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||6.1|-7.9|0.8080
73940762|NCT03053050|147413531|SUPERIORITY||Percentage Difference|-2.0||||0.5636|TWO_SIDED|95.0|-8.7|4.8||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||4.8|-8.7|0.5636
73940763|NCT03053050|147413531|SUPERIORITY||Percentage Difference|-1.9||||0.5915|TWO_SIDED|95.0|-8.6|4.9||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||4.9|-8.6|0.5915
74031170|NCT01254604|147615884|SUPERIORITY_OR_OTHER||Difference in percentage|-3.9|||||TWO_SIDED|95.0|-17.3|9.4|||Miettinen and Nurminen||Between-group difference in percentage of participants with an AE = percentage (tafluprost) - percentage (timolol)|||9.4|-17.3|
74031171|NCT01254604|147615885|SUPERIORITY_OR_OTHER||Difference in percentage|1.1|||||TWO_SIDED|95.0|-3.5|5.7|||Miettinen and Nurminen||Between-group difference in percentage of participants discontinued study drug due to an AE = percentage (tafluprost) - percentage (timolol)|||5.7|-3.5|
73940764|NCT03053050|147413533|SUPERIORITY||Percentage Difference|-3.2||||0.2455|TWO_SIDED|95.0|-8.5|2.2||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||2.2|-8.5|0.2455
73940765|NCT03053050|147413533|SUPERIORITY||Percentage Difference|-4.0||||0.1371|TWO_SIDED|95.0|-9.3|1.3||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||1.3|-9.3|0.1371
73940766|NCT05338333|147413535|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.006|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens-by-visit interaction, period, sequence, and habitual lens stratum) and random (subject) effects. Difference = LID210464 minus AOHG MF.|||0.00||
73940767|NCT02459574|147413537|SUPERIORITY||Hazard Ratio (HR)|0.156|||<|0.0001|TWO_SIDED|95.0|0.097|0.25||Bonferonni corrected alpha of 0.05/2 = 0.025|Log Rank||95% Wald Confidence Limits Point estimate relates to AVATAR-AF in relation to Anti-Arrhythmic Therapy|Primary Analysis - AVATAR-AF vs Anti-Arrhythmic Therapy||0.250|0.097|<0.0001
73940768|NCT02459574|147413537|SUPERIORITY||Hazard Ratio (HR)|1.173||||0.6061|TWO_SIDED|95.0|0.639|2.154||Bonferonni corrected alpha 0.05/2 = 0.025|Log Rank||95% Wald Confidence Limits Point estimate relates to AVATAR-AF in relation to Conventional Ablation|Secondary analysis of Primary Outcome measure - AVATAR-AF vs Conventional Ablation||2.154|0.639|0.6061
73940769|NCT00251745|147413541|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
73940770|NCT00251745|147413541|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
73940771|NCT00251745|147413541|SUPERIORITY_OR_OTHER|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.15505
73940772|NCT00251745|147413543|SUPERIORITY_OR_OTHER|||||||1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.00001
73940773|NCT00251745|147413543|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
73940774|NCT00251745|147413543|SUPERIORITY_OR_OTHER|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.38740
73940775|NCT00636649|147413547|SUPERIORITY_OR_OTHER|||||||0.993|||||||ANCOVA|||CISS-TASK||||0.993
73940776|NCT00636649|147413547|SUPERIORITY_OR_OTHER|||||||0.185|||||||ANCOVA|||CISS-EMOT||||0.185
73940777|NCT00636649|147413547|SUPERIORITY_OR_OTHER|||||||0.196|||||||ANCOVA|||CISS-DIS||||0.196
73940778|NCT00636649|147413547|SUPERIORITY_OR_OTHER|||||||0.759|||||||ANCOVA|||CISS-AVD||||0.759
74031172|NCT03074162|147615886|EQUIVALENCE|The statistical model was an variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|45.54|STANDARD_ERROR_OF_MEAN|35.99|||TWO_SIDED|90.0|40.11|51.7|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/R) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.|||51.70|40.11|
73940779|NCT00636649|147413547|SUPERIORITY_OR_OTHER|||||||0.396|||||||ANCOVA|||CISS-SOC||||0.396
73940780|NCT00636649|147413548|SUPERIORITY_OR_OTHER|||||||0.579|||||||ANCOVA|||||||0.579
73940781|NCT00636649|147413549|SUPERIORITY_OR_OTHER|||||||0.225|||||||ANCOVA|||TFEQ-RES||||0.225
73940782|NCT00636649|147413549|SUPERIORITY_OR_OTHER|||||||0.498|||||||ANCOVA|||TFEQ-DIS||||0.498
73940783|NCT00636649|147413549|SUPERIORITY_OR_OTHER|||||||0.724|||||||ANCOVA|||TFEQ-HUN||||0.724
73940784|NCT04171102|147413576|OTHER|||||||0.028||||||\<0.05|t-test, 2 sided|||||||0.028
73940785|NCT04179175|147413609|OTHER||Hazard Ratio (HR)|0.87||||0.25|TWO_SIDED|95.0|0.59|1.29|||Log Rank|one-sided stratified log-rank test, with region and body weight (\<90 kg, ≥ 90 kg) as strata||||1.29|0.59|0.250
73974214|NCT04518943|147493183|SUPERIORITY||Mean Difference (Net)|-0.17||||0.446|TWO_SIDED|90.0|-0.54|0.2|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 24. It compares intrinsic motivation at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.20|-0.54|0.446
73974215|NCT04518943|147493183|SUPERIORITY||Mean Difference (Net)|0.08||||0.711|TWO_SIDED|90.0|-0.27|0.42|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.42|-0.27|0.711
73974216|NCT04518943|147493183|SUPERIORITY||Mean Difference (Net)|-0.2||||0.345|TWO_SIDED|90.0|-0.55|0.15|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.15|-0.55|0.345
73940786|NCT04179175|147413609|OTHER||Hazard Ratio (HR)|0.7||||0.044|TWO_SIDED|95.0|0.47|1.05|||Log Rank|one-sided stratified log-rank test, with region and body weight (\<90 kg, ≥ 90 kg) as strata||||1.05|0.47|0.044
73940787|NCT04149925|147413646|SUPERIORITY|||||||0.01||||||Significant when p\<0.05|t-test, 2 sided|||||||0.01
73940788|NCT02586025|147413652|SUPERIORITY||Difference in response rates|17.45||||0.0014|TWO_SIDED|95.0|6.89|28.01||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||28.01|6.89|0.0014
73940789|NCT02586025|147413653|SUPERIORITY||Difference in response rates|18.36||||0.0008|TWO_SIDED|95.0|7.89|28.83||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||28.83|7.89|0.0008
73940790|NCT02586025|147413654|SUPERIORITY||Difference in response rates|18.37||||0.001|TWO_SIDED|95.0|7.6|29.15||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||29.15|7.60|0.0010
73940791|NCT02586025|147413655|SUPERIORITY||Difference in response rates|18.83||||0.0006|TWO_SIDED|95.0|8.14|29.51||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||29.51|8.14|0.0006
73940792|NCT02586025|147413657|SUPERIORITY||Difference in response rates|10.4||||0.0125|TWO_SIDED|95.0|1.12|19.69||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm|||19.69|1.12|0.0125
73940793|NCT02586025|147413658|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.014|TWO_SIDED|95.0|0.32|0.89|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for EFS Event in the Pertuzumab arm vs. Placebo arm||0.89|0.32|0.0140
73940794|NCT02586025|147413658|SUPERIORITY||Difference in EFS Event-Free Rates|-8.16||||0.0062|TWO_SIDED|95.0|-14.0|-2.32|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 1 year||-2.32|-14.00|0.0062
73940795|NCT02586025|147413658|SUPERIORITY||Difference in EFS Event-Free Rates|-9.17||||0.0429|TWO_SIDED|95.0|-18.05|-0.29|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 3 years||-0.29|-18.05|0.0429
73940796|NCT02586025|147413658|SUPERIORITY||Difference in EFS Event-Free Rates|-11.1||||0.0274|TWO_SIDED|95.0|-20.95|-1.24|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 5 Years||-1.24|-20.95|0.0274
73940797|NCT02586025|147413659|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.014|TWO_SIDED|95.0|0.3|0.88|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for DFS Event in the Pertuzumab arm vs. Placebo arm||0.88|0.30|0.0140
73940798|NCT02586025|147413659|SUPERIORITY||Difference in DFS Event-Free Rates|-5.47||||0.0592|TWO_SIDED|95.0|-11.15|0.21|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 1 year||0.21|-11.15|0.0592
73940799|NCT02586025|147413659|SUPERIORITY||Difference in DFS Event-Free Rates|-9.0||||0.0426|TWO_SIDED|95.0|-17.69|-0.3|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 3 years||-0.30|-17.69|0.0426
73974217|NCT04518943|147493183|SUPERIORITY||Mean Difference (Net)|0.02||||0.928|TWO_SIDED|90.0|-0.33|0.36|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive a request for advice compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.36|-0.33|0.928
73974218|NCT04518943|147493183|SUPERIORITY||Mean Difference (Net)|-0.19||||0.372|TWO_SIDED|90.0|-0.55|0.16|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares intrinsic motivation at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.16|-0.55|0.372
73974219|NCT04518943|147493184|SUPERIORITY||Mean Difference (Net)|0.35||||0.767|TWO_SIDED|90.0|-1.6|2.3|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares phq8 mental health scores in week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.3|-1.60|0.767
73974220|NCT04518943|147493184|SUPERIORITY||Mean Difference (Net)|0.78||||0.5|TWO_SIDED|90.0|-1.12|2.69|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 24. It compares phq8 mental health scores in week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.69|-1.12|0.500
73974221|NCT04518943|147493184|SUPERIORITY||Mean Difference (Net)|0.59||||0.631|TWO_SIDED|90.0|-1.43|2.61|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 12. It compares phq8 mental health scores at week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24, and interactions between factors and weeks.||2.61|-1.43|0.631
73974222|NCT04518943|147493184|SUPERIORITY||Mean Difference (Net)|-0.62||||0.62|TWO_SIDED|90.0|-2.69|1.44|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 24. It compares phq8 mental health scores at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24, and interactions between factors and weeks.||1.44|-2.69|0.620
73974223|NCT04518943|147493184|SUPERIORITY||Mean Difference (Net)|0.17||||0.886|TWO_SIDED|90.0|-1.77|2.12|||Regression, Linear|||This is the results of pre-commitment (PC) vs no PC factor at week 12. It compares phq8 mental health scores at week 12 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.12|-1.77|0.886
73974224|NCT04518943|147493184|SUPERIORITY||Mean Difference (Net)|-0.07||||0.95|TWO_SIDED|-2.03|-2.03|1.88|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares phq8 mental health scores at week 24 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.88|-2.03|0.950
74089080|NCT03575871|147731430|SUPERIORITY||Difference in Percentage|11.9||||0.0246|TWO_SIDED|95.0|2.4|21.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.4|2.4|0.0246
73867462|NCT00235716|147279957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.84|TWO_SIDED|95.0|-0.65|0.8||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.80|-0.65|0.84
73940800|NCT02586025|147413659|SUPERIORITY||Difference in DFS Event-Free Rates|-10.97||||0.0276|TWO_SIDED|95.0|-20.73|-1.21|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 5 years||-1.21|-20.73|0.0276
73940801|NCT02586025|147413660|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.1181|TWO_SIDED|95.0|0.23|1.19|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for OS Event in the Pertuzumab arm vs. Placebo arm||1.19|0.23|0.1181
73867463|NCT00235716|147279958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.1|TWO_SIDED|95.0|-3.28|-0.33||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.33|-3.28|0.10
74089081|NCT03575871|147731430|SUPERIORITY||Difference in Percentage|26.9|||<|0.0001|TWO_SIDED|95.0|17.0|36.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.9|17.0|<0.0001
74089082|NCT03575871|147731431|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.7|3.7||P-value was not estimable since there were no events.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.7|-3.7|
74089083|NCT03575871|147731431|SUPERIORITY||Difference in Percentage|1.9||||0.2262|TWO_SIDED|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.1|-2.2|0.2262
74089084|NCT03575871|147731431|SUPERIORITY||Difference in Percentage|1.9||||0.2223|TWO_SIDED|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.1|-2.2|0.2223
74089085|NCT03575871|147731431|SUPERIORITY||Difference in Percentage|4.5||||0.0597|TWO_SIDED|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-0.2|0.0597
74089086|NCT03575871|147731431|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-2.7|0.3207
74089087|NCT03575871|147731431|SUPERIORITY||Difference in Percentage|4.5||||0.0586|TWO_SIDED|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-0.2|0.0586
74089088|NCT03575871|147731431|SUPERIORITY||Difference in Percentage|5.2||||0.0419|TWO_SIDED|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.1|0.3|0.0419
73940802|NCT02586025|147413660|SUPERIORITY||Difference in OS Event-Free Rates|0.46||||0.3162|TWO_SIDED|95.0|-0.44|1.36|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 1 year||1.36|-0.44|0.3162
73940803|NCT02586025|147413660|SUPERIORITY||Difference in OS Event-Free Rates|-6.02||||0.0529|TWO_SIDED|95.0|-12.11|0.08|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 3 years||0.08|-12.11|0.0529
74089089|NCT03575871|147731431|SUPERIORITY||Difference in Percentage|6.3||||0.0244|TWO_SIDED|95.0|1.2|11.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.4|1.2|0.0244
73940804|NCT02586025|147413660|SUPERIORITY||Difference in OS Event-Free Rates|-3.89||||0.2616|TWO_SIDED|95.0|-10.69|2.9|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 5 years||2.90|-10.69|0.2616
73940805|NCT02586025|147413666|OTHER||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-1.62|0.93|||||Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm|||0.93|-1.62|
73940806|NCT00175825|147413678|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|9.8|||=|0.24|TWO_SIDED|95.0|-7.2|24.0|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||24.0|-7.2|=0.240
73940807|NCT00175825|147413678|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|14.9|||=|0.062|TWO_SIDED|95.0|-0.8|28.2|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||28.2|-0.8|=0.062
73940808|NCT00175825|147413678|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|22.1|||=|0.004|TWO_SIDED|95.0|7.6|34.3|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||34.3|7.6|=0.004
73940809|NCT03014674|147413686|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% confidence interval (CI) for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.04|||||TWO_SIDED|90.0|0.98|1.11|||||Ratio (autoinjector/lyophilized drug) for Cmax has been presented|||1.11|0.98|
73940810|NCT03014674|147413686|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.06|||||TWO_SIDED|90.0|0.99|1.12|||||Ratio (safety syringe/lyophilized drug) for Cmax has been presented|||1.12|0.99|
73940811|NCT03014674|147413687|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t)|Ratio|1.08|||||TWO_SIDED|90.0|1.01|1.15|||||Ratio (autoinjector/lyophilized drug) for AUC(0-t) has been presented|||1.15|1.01|
73940812|NCT03014674|147413687|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t).|Ratio|1.04|||||TWO_SIDED|90.0|0.97|1.12|||||Ratio (safety syringe/lyophilized drug) for AUC(0-t) has been presented|||1.12|0.97|
73867464|NCT00235716|147279958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39||||0.25|TWO_SIDED|95.0|-2.85|0.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.07|-2.85|0.25
73867465|NCT00235716|147279958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.65||||0.14|TWO_SIDED|95.0|-3.12|-0.17||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.17|-3.12|0.14
73974225|NCT04518943|147493184|SUPERIORITY||Mean Difference (Net)|-1.45||||0.248|TWO_SIDED|90.0|-3.51|0.61|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares phq mental health scores at week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.61|-3.51|0.248
73974226|NCT04518943|147493184|SUPERIORITY||Mean Difference (Net)|-1.23||||0.317|TWO_SIDED|90.0|-3.25|0.79|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares phq mental health scores at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.79|-3.25|0.317
73974227|NCT04518943|147493185|SUPERIORITY||Mean Difference (Net)|-35.0||||0.972|TWO_SIDED|90.0|-1685.0|1616.0|||Mixed Models Analysis|||This is the results of financial vs non-financial reward factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1616|-1685|0.972
74089090|NCT03575871|147731432|SUPERIORITY||Difference in Percentage|25.0|||<|0.0001|TWO_SIDED|95.0|14.8|35.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.2|14.8|<0.0001
73867466|NCT00235716|147279958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.84|TWO_SIDED|95.0|-1.32|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.63|-1.32|0.84
73940813|NCT03014674|147413687|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.07|||||TWO_SIDED|90.0|1.0|1.13|||||Ratio (autoinjector/lyophilized drug) for AUC(0-inf) has been presented|||1.13|1.00|
73940814|NCT03014674|147413687|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.02|||||TWO_SIDED|90.0|0.95|1.09|||||Ratio (safety syringe/lyophilized drug) for AUC(0-inf) has been presented|||1.09|0.95|
73940815|NCT00833560|147413705|SUPERIORITY_OR_OTHER||Percentage of participants with response|85.4|||<|0.0001|TWO_SIDED|95.0|81.5|88.8|||Two - sided binomial test|||||88.8|81.5|<0.0001
73940816|NCT00833560|147413706|SUPERIORITY_OR_OTHER||Percentage of participants with response|87.7|||<|0.0001|TWO_SIDED|95.0|83.6|91.0|||Two-sided binomial test|||||91.0|83.6|<0.0001
74089091|NCT03575871|147731432|SUPERIORITY||Difference in Percentage|44.2|||<|0.0001|TWO_SIDED|95.0|33.9|54.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||54.6|33.9|<0.0001
73940817|NCT02080871|147413717|OTHER|This was a single-arm study designed to compare the primary outcome result to a performance goal based on published literature. The null hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of study device is at least 17%. The alternate hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of the study device is less than 17%.|||||<|0.001|||||||one-sided binomial exact test|||The sample size obtains over 90% power to statistically show the probability that a subject will experience an MAE with use of the study device is less than 17% when 12% or less of the subjects are lost to follow up prior to 9 months.||||<0.001
74089092|NCT03575871|147731432|SUPERIORITY||Difference in Percentage|30.2|||<|0.0001|TWO_SIDED|95.0|17.5|42.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.8|17.5|<0.0001
74089093|NCT03575871|147731432|SUPERIORITY||Difference in Percentage|49.8|||<|0.0001|TWO_SIDED|95.0|37.8|61.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||61.7|37.8|<0.0001
74089094|NCT03575871|147731432|SUPERIORITY||Difference in Percentage|31.5|||<|0.0001|TWO_SIDED|95.0|18.8|44.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.3|18.8|<0.0001
74089095|NCT03575871|147731432|SUPERIORITY||Difference in Percentage|47.6|||<|0.0001|TWO_SIDED|95.0|35.7|59.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||59.6|35.7|<0.0001
74089096|NCT03575871|147731432|SUPERIORITY||Difference in Percentage|48.7|||<|0.0001|TWO_SIDED|95.0|37.2|60.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.1|37.2|<0.0001
73867467|NCT00235716|147279958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.84|TWO_SIDED|95.0|-1.72|1.21||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.21|-1.72|0.84
73940818|NCT02606903|147413810|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|110.19|STANDARD_DEVIATION|33.603|||TWO_SIDED|90.0|96.8|125.44|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and body mass index (BMI) group as fixed effects||125.44|96.80|
73940819|NCT02606903|147413811|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|100.14|STANDARD_DEVIATION|42.354|||TWO_SIDED|90.0|85.15|117.76|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects||117.76|85.15|
74089097|NCT03575871|147731432|SUPERIORITY||Difference in Percentage|60.1|||<|0.0001|TWO_SIDED|95.0|49.1|71.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||71.0|49.1|<0.0001
73940820|NCT02606903|147413812|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|100.22|STANDARD_DEVIATION|53.137|||TWO_SIDED|90.0|82.13|122.29|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects||122.29|82.13|
73940821|NCT02548455|147413814|EQUIVALENCE|Freedom from left ventricular lead-related complications through 3 months was estimated to be 96.0% with a 95% lower confidence bound of 92.6% based on the Promote Q IDE study (NCT00990665), and 98.3% with a 95% lower confidence bound of 97.7% based on data from the Quadripolar Post-Approval study (NCT01555619).|Kaplan-Meier Estimate|85.0||||0.05|TWO_SIDED||||||Log Rank|||"The hypothesis for the endpoint is:~H0: Freedom from LV lead-related complications through 3 months (91 days) ≤ 85% H1: Freedom from LV lead-related complications through 3 months (91 days) \> 85%~A total of 85 subjects were required to have at least 80% power to reject the null hypothesis at the 5% significance level at three months (91 days) post-implant or attempted implant. After accounting for 9% attrition, the required sample size was 94 subjects."||||0.05
73940822|NCT00338884|147413832|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|35.3|||||TWO_SIDED|95.0|26.7|44.8|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.|||44.8|26.7|
73940823|NCT00338884|147413838|SUPERIORITY_OR_OTHER|||||||0.5581|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5581
73940824|NCT00338884|147413838|SUPERIORITY_OR_OTHER|||||||0.7635|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.7635
73940825|NCT00338884|147413838|SUPERIORITY_OR_OTHER|||||||0.8366|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.8366
73940826|NCT00338884|147413838|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.0278
73940827|NCT00338884|147413838|SUPERIORITY_OR_OTHER|||||||0.1988|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.1988
73940828|NCT00338884|147413838|SUPERIORITY_OR_OTHER|||||||0.2898|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.2898
73940829|NCT00338884|147413838|SUPERIORITY_OR_OTHER|||||||0.3567|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.3567
73940830|NCT00338884|147413838|SUPERIORITY_OR_OTHER|||||||0.4547|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.4547
73940831|NCT00338884|147413838|SUPERIORITY_OR_OTHER|||||||0.2809|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.2809
73940832|NCT00338884|147413838|SUPERIORITY_OR_OTHER|||||||0.3259|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.3259
73940833|NCT00338884|147413838|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2702
73940834|NCT00338884|147413839|SUPERIORITY_OR_OTHER|||||||0.7154|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7154
73940835|NCT00338884|147413839|SUPERIORITY_OR_OTHER|||||||0.6263|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6263
73940836|NCT00338884|147413839|SUPERIORITY_OR_OTHER|||||||0.9608|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9608
73940837|NCT00338884|147413839|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0300
73940838|NCT00338884|147413839|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0927
73940839|NCT00338884|147413839|SUPERIORITY_OR_OTHER|||||||0.2873|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2873
73940840|NCT00338884|147413839|SUPERIORITY_OR_OTHER|||||||0.3018|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3018
73940841|NCT00338884|147413839|SUPERIORITY_OR_OTHER|||||||0.4161|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4161
73940842|NCT00338884|147413839|SUPERIORITY_OR_OTHER|||||||0.3069|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3069
73940843|NCT00338884|147413839|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2920
73940844|NCT00338884|147413839|SUPERIORITY_OR_OTHER|||||||0.2409|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2409
73940845|NCT00338884|147413841|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5784
73940846|NCT00338884|147413841|SUPERIORITY_OR_OTHER|||||||0.6251|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.6251
73940847|NCT00338884|147413841|SUPERIORITY_OR_OTHER|||||||0.1639|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.1639
73940848|NCT00338884|147413841|SUPERIORITY_OR_OTHER|||||||0.2782|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.2782
73940849|NCT00338884|147413841|SUPERIORITY_OR_OTHER|||||||0.8627|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.8627
73940850|NCT00338884|147413841|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.4620
73940851|NCT00338884|147413841|SUPERIORITY_OR_OTHER|||||||0.7575|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.7575
73940852|NCT00338884|147413841|SUPERIORITY_OR_OTHER|||||||0.3566|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.3566
73940853|NCT00338884|147413841|SUPERIORITY_OR_OTHER|||||||0.2809|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.2809
73940854|NCT00338884|147413841|SUPERIORITY_OR_OTHER|||||||0.8758|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.8758
73940855|NCT00338884|147413841|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2702
73940856|NCT00338884|147413842|SUPERIORITY_OR_OTHER|||||||0.7267|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7267
73940857|NCT00338884|147413842|SUPERIORITY_OR_OTHER|||||||0.8555|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8555
73940858|NCT00338884|147413842|SUPERIORITY_OR_OTHER|||||||0.2259|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2259
73940859|NCT00338884|147413842|SUPERIORITY_OR_OTHER|||||||0.2074|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2074
73940860|NCT00338884|147413842|SUPERIORITY_OR_OTHER|||||||0.4779|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4779
73940861|NCT00338884|147413842|SUPERIORITY_OR_OTHER|||||||0.3628|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3628
73940862|NCT00338884|147413842|SUPERIORITY_OR_OTHER|||||||0.546|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5460
73974228|NCT04518943|147493185|SUPERIORITY||Mean Difference (Net)|-2428.0||||0.019|TWO_SIDED|90.0|-4134.0|-722.0|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||-722|-4134|0.019
73974229|NCT04518943|147493185|SUPERIORITY||Mean Difference (Net)|418.0||||0.627|TWO_SIDED|90.0|-999.0|1836.0|||Mixed Models Analysis|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive a request for PC compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1836|-999|0.627
74089098|NCT03575871|147731433|SUPERIORITY||Difference in Percentage|2.5||||0.1623|TWO_SIDED|95.0|-1.7|6.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.8|-1.7|0.1623
73940863|NCT00338884|147413842|SUPERIORITY_OR_OTHER|||||||0.3637|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3637
73940864|NCT00338884|147413842|SUPERIORITY_OR_OTHER|||||||0.2229|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2229
73940865|NCT00338884|147413842|SUPERIORITY_OR_OTHER|||||||0.9759|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9759
73940866|NCT00338884|147413842|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2179
73940867|NCT00338884|147413844|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5784
73940868|NCT00338884|147413844|SUPERIORITY_OR_OTHER|||||||0.9625|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.9625
73940869|NCT00338884|147413844|SUPERIORITY_OR_OTHER|||||||0.8519|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.8519
73940870|NCT00338884|147413844|SUPERIORITY_OR_OTHER||Wilcoxon Rank Sum Test|||||0.0513|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.0513
73940871|NCT00338884|147413844|SUPERIORITY_OR_OTHER|||||||0.4051|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.4051
73940872|NCT00338884|147413844|SUPERIORITY_OR_OTHER|||||||0.2548|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.2548
73940873|NCT00338884|147413844|SUPERIORITY_OR_OTHER|||||||0.5091|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.5091
73940874|NCT00338884|147413844|SUPERIORITY_OR_OTHER|||||||0.3133|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.3133
73940875|NCT00338884|147413844|SUPERIORITY_OR_OTHER|||||||0.9278|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.9278
73940876|NCT00338884|147413844|SUPERIORITY_OR_OTHER|||||||0.407|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.4070
73940877|NCT00338884|147413844|SUPERIORITY_OR_OTHER|||||||0.2703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2703
73940878|NCT00338884|147413845|SUPERIORITY_OR_OTHER|||||||0.7267|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7267
73940879|NCT00338884|147413845|SUPERIORITY_OR_OTHER|||||||0.8286|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8286
73940880|NCT00338884|147413845|SUPERIORITY_OR_OTHER|||||||0.6867|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6867
73940881|NCT00338884|147413845|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0450
73940882|NCT00338884|147413845|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1740
73940883|NCT00338884|147413845|SUPERIORITY_OR_OTHER|||||||0.2703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2703
73940884|NCT00338884|147413845|SUPERIORITY_OR_OTHER|||||||0.3659|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3659
73940885|NCT00338884|147413845|SUPERIORITY_OR_OTHER|||||||0.3391|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3391
73940886|NCT00338884|147413845|SUPERIORITY_OR_OTHER|||||||0.98|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9800
73940887|NCT00338884|147413845|SUPERIORITY_OR_OTHER|||||||0.335|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3350
73940888|NCT00338884|147413845|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2179
73867468|NCT00235716|147279958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.84|TWO_SIDED|95.0|-1.88|1.06||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.06|-1.88|0.84
73940889|NCT00338884|147413848|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD||||0.0680
73867469|NCT00235716|147279959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.46||||0.94|TWO_SIDED|95.0|-3.55|0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.63|-3.55|0.94
73867470|NCT00235716|147279959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.94|TWO_SIDED|95.0|-2.47|1.7||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.70|-2.47|0.94
73867471|NCT00235716|147279959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.94|TWO_SIDED|95.0|-2.57|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.63|-2.57|0.94
73867472|NCT00235716|147279959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.94|TWO_SIDED|95.0|-1.09|3.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.07|-1.09|0.94
73940890|NCT00338884|147413849|SUPERIORITY_OR_OTHER|||||||0.1159|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR or (SD \> = 12 Weeks) Versus PD||||0.1159
73940891|NCT00338884|147413851|SUPERIORITY_OR_OTHER|||||||0.8519|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.8519
73940892|NCT00338884|147413851|SUPERIORITY_OR_OTHER|||||||0.5879|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.5879
73940893|NCT00338884|147413851|SUPERIORITY_OR_OTHER|||||||0.4757|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.4757
73974230|NCT04518943|147493185|SUPERIORITY||Mean Difference (Net)|195.0||||0.842|TWO_SIDED|90.0|-1417.0|1807.0|||Mixed Models Analysis|||This is the results of advice vs no advice factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1807|-1417|0.842
73940894|NCT00338884|147413851|SUPERIORITY_OR_OTHER|||||||0.1933|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.1933
73940895|NCT00338884|147413851|SUPERIORITY_OR_OTHER|||||||0.4187|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.4187
73940896|NCT00338884|147413851|SUPERIORITY_OR_OTHER|||||||0.3795|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.3795
73940897|NCT00338884|147413851|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||1.0000
73940898|NCT00338884|147413851|SUPERIORITY_OR_OTHER|||||||0.6333|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.6333
73940899|NCT00338884|147413851|SUPERIORITY_OR_OTHER|||||||0.8679|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.8679
73940900|NCT00338884|147413851|SUPERIORITY_OR_OTHER|||||||0.592|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.5920
73940901|NCT00338884|147413852|SUPERIORITY_OR_OTHER|||||||0.6939|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6939
73940902|NCT00338884|147413852|SUPERIORITY_OR_OTHER|||||||0.5871|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5871
73940903|NCT00338884|147413852|SUPERIORITY_OR_OTHER|||||||0.4572|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4572
73940904|NCT00338884|147413852|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1120
73940905|NCT00338884|147413852|SUPERIORITY_OR_OTHER|||||||0.4896|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4896
73940906|NCT00338884|147413852|SUPERIORITY_OR_OTHER|||||||0.2369|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2369
73940907|NCT00338884|147413852|SUPERIORITY_OR_OTHER|||||||0.6709|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6709
73940908|NCT00338884|147413852|SUPERIORITY_OR_OTHER|||||||0.6382|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6382
73940909|NCT00338884|147413852|SUPERIORITY_OR_OTHER|||||||0.8481|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8481
73940910|NCT00338884|147413852|SUPERIORITY_OR_OTHER|||||||0.3731|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3731
73940911|NCT00338884|147413854|SUPERIORITY_OR_OTHER|||||||0.0292|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD||||0.0292
73867473|NCT00235716|147279959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.94|TWO_SIDED|95.0|-2.16|1.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.99|-2.16|0.94
73867474|NCT00235716|147279959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.08||||0.94|TWO_SIDED|95.0|-3.14|0.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.99|-3.14|0.94
73867475|NCT00235716|147279960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.79||||0.12|TWO_SIDED|95.0|-3.35|-0.23||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.23|-3.35|0.12
73940912|NCT00338884|147413855|SUPERIORITY_OR_OTHER|||||||0.1087|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR or (SD \> = 12 Weeks) Versus PD||||0.1087
73940913|NCT00338884|147413857|SUPERIORITY_OR_OTHER|||||||0.3386|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.3386
73940914|NCT00338884|147413857|SUPERIORITY_OR_OTHER|||||||0.1949|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.1949
73940915|NCT00338884|147413857|SUPERIORITY_OR_OTHER|||||||0.7037|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.7037
73940916|NCT00338884|147413857|SUPERIORITY_OR_OTHER|||||||0.5748|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.5748
73940917|NCT00338884|147413857|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.7470
73867476|NCT00235716|147279960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.86|TWO_SIDED|95.0|-1.18|1.94||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.94|-1.18|0.86
73940918|NCT00338884|147413857|SUPERIORITY_OR_OTHER|||||||0.4703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.4703
73940919|NCT00338884|147413857|SUPERIORITY_OR_OTHER|||||||0.8162|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.8162
73940920|NCT00338884|147413857|SUPERIORITY_OR_OTHER|||||||0.5465|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.5465
73940921|NCT00338884|147413857|SUPERIORITY_OR_OTHER|||||||0.3495|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.3495
73940922|NCT00338884|147413857|SUPERIORITY_OR_OTHER|||||||0.6397|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.6397
73940923|NCT00338884|147413858|SUPERIORITY_OR_OTHER|||||||0.4632|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4632
73940924|NCT00338884|147413858|SUPERIORITY_OR_OTHER|||||||0.1701|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1701
73940925|NCT00338884|147413858|SUPERIORITY_OR_OTHER|||||||0.8204|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8204
73940926|NCT00338884|147413858|SUPERIORITY_OR_OTHER|||||||0.5162|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5162
73940927|NCT00338884|147413858|SUPERIORITY_OR_OTHER|||||||0.9437|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9437
73940928|NCT00338884|147413858|SUPERIORITY_OR_OTHER|||||||0.4013|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4013
73940929|NCT00338884|147413858|SUPERIORITY_OR_OTHER|||||||0.9595|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9595
73940930|NCT00338884|147413858|SUPERIORITY_OR_OTHER|||||||0.6249|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6249
73940931|NCT00338884|147413858|SUPERIORITY_OR_OTHER|||||||0.3731|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3731
73940932|NCT00338884|147413858|SUPERIORITY_OR_OTHER|||||||0.8263|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8263
73940933|NCT01970982|147413868|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.09|||<|0.001|TWO_SIDED|95.0|18.41|28.95||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||28.95|18.41|<0.001
73940934|NCT01970982|147413869|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|52.86|||<|0.001|TWO_SIDED|95.0|45.67|61.17||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||61.17|45.67|<0.001
73940935|NCT01970982|147413870|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|15.68|||<|0.001|TWO_SIDED|95.0|13.09|18.78||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||18.78|13.09|<0.001
73940936|NCT01970982|147413871|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|47.1|||<|0.001|TWO_SIDED|95.0|44.3|50.08||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||50.08|44.30|<0.001
73940937|NCT01984684|147413885|NON_INFERIORITY|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in responder rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|3.1|||||TWO_SIDED|95.0|-2.0|8.3||||||||8.3|-2.0|
73940938|NCT01984684|147413886|NON_INFERIORITY|Analysis of the investigator's assessment of response of signs and symptoms of infection (cure only) was performed using the Miettinen-Nurminen method without stratification for the ITT analysis set.|Difference in Cure Rates|-2.0|||||TWO_SIDED|95.0|-8.6|4.6||||||||4.6|-8.6|
73940939|NCT01984684|147413887|NON_INFERIORITY|Analysis of the investigator's assessment of response (cure only) at the Late Follow-up Visit was assessed using the Miettinen-Nurminen method without stratification.|Difference in Cure Rates|-3.1|||||TWO_SIDED|95.0|-9.3|3.1||||||||3.1|-9.3|
73974231|NCT00624442|147493237|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0||||0.8842|TWO_SIDED|95.0|-7.0|8.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||8|-7|0.8842
73974232|NCT00624442|147493237|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|18.0|||<|0.0001|TWO_SIDED|95.0|10.0|27.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||27|10|<0.0001
73974233|NCT00624442|147493237|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|47.0|||<|0.0001||95.0|38.0|56.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||56|38|<0.0001
73974234|NCT00624442|147493237|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|58.0|||<|0.0001|TWO_SIDED|95.0|46.0|70.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||70|46|<0.0001
73974235|NCT00624442|147493237|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|59.0|||<|0.0001|TWO_SIDED|95.0|47.0|72.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||72|47|<0.0001
73867477|NCT00235716|147279960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.86|TWO_SIDED|95.0|-1.7|1.42||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.42|-1.70|0.86
73974236|NCT00624442|147493237|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|80.0|||<|0.0001|TWO_SIDED|95.0|71.0|89.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||89|71|<0.0001
73974237|NCT00624442|147493237|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding systolic ejection time PD assessment (not binned based on plasma concentration)"||||<0.0001
73974238|NCT00624442|147493238|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0||||0.3665|TWO_SIDED|95.0|-1.0|2.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||2|-1|0.3665
73974239|NCT00624442|147493238|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0|||<|0.0357|TWO_SIDED|95.0|0.0|3.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||3|0|<0.0357
73974240|NCT00624442|147493238|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|3.0||||0.0004|TWO_SIDED|95.0|1.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||5|1|0.0004
73974241|NCT00624442|147493238|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|3.0||||0.0086|TWO_SIDED|95.0|1.0|4.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||4|1|0.0086
73974242|NCT00624442|147493238|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|2.0||||0.032|TWO_SIDED|95.0|0.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||5|0|0.032
73957997|NCT03368001|147451528|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|0.005|||>|0.05|TWO_SIDED|90.0|-0.015|0.059||One-sided hypothesis test|Structural Equation Model (SEM)|Controlling for Social Anxiety at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up Social Anxiety through posttest IFM. Adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.059|-0.015|>0.05
73974243|NCT00624442|147493238|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|5.0|||<|0.0001|TWO_SIDED|95.0|3.0|6.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||6|3|<0.0001
73974244|NCT00624442|147493238|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding fractional shortening PD assessment (not binned based on plasma concentration)"||||<0.0001
73974245|NCT00003222|147493272|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.||||0.13
73974246|NCT00003222|147493273|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.||||0.004
73974247|NCT00391443|147493340|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.211|TWO_SIDED|95.0|0.658|1.097|||Log Rank|||||1.097|0.658|0.2110
73974248|NCT00391443|147493341|SUPERIORITY_OR_OTHER_LEGACY||Relative risk reduction|0.17||||0.2542|TWO_SIDED|95.0|-0.13|0.39|||Fisher Exact|||||0.39|-0.13|0.2542
73974249|NCT02379351|147493355|OTHER|This pilot study is primarily descriptive statistics||||||0.1|||||||Chi-squared|Data analysis will use mostly descriptive statistics - parametric and nonparametric statistics will be used as indicated (Chi-squared)||||||.1
73940940|NCT05711641|147413896|OTHER|VAS was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|Generalized Estimating Equations|||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|VAS was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
73940941|NCT05711641|147413897|OTHER|Tinnitus loudness was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).||||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|Tinnitus loudness was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
74039425|NCT04847141|147632418|SUPERIORITY||Difference in Percentage|2.7||||0.1878|TWO_SIDED|95.0|-1.6|7.5||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required hospital admission between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||7.5|-1.6|0.1878
73940942|NCT05711641|147413898|OTHER|MML was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).||||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|MML was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
73940943|NCT04575051|147413899|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.58|TWO_SIDED|95.0|-1.1|1.96|||Mixed Models Analysis||Difference in the adjusted means for the Consult model and HearCARE model.|The null hypothesis is that the HearCARE intervention does not improve satisfaction with social participation.||1.96|-1.10|0.58
73940944|NCT04575051|147413900|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.95|TWO_SIDED|95.0|-1.13|1.1|||Mixed Models Analysis||The estimated parameter represents the difference between the adjusted means for the Consult and HearCARE models.|The null hypothesis is that the HearCARE intervention does not improve hearing related quality of life.||1.10|-1.13|0.95
73940945|NCT04575051|147413901|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.96|TWO_SIDED|95.0|-1.2|1.14|||Mixed Models Analysis||Estimated Value represents the difference in the means for the Consult and HearCARE models.|||1.14|-1.20|0.96
73940946|NCT04575051|147413902|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.13|TWO_SIDED|95.0|-0.07|0.48|||Mixed Models Analysis||The Estimated Value is the difference between the means of the Consult and HearCARE models.|||0.48|-0.07|0.13
73940947|NCT03624504|147413903|OTHER|Assume expected performance to be 94%. The Objective Performance Criterion (OPC) is set at 83% (same performance threshold in FDA approved global study). Assumes 0.05 significance level, 2-sided, 80% power and 10% study attrition.|Kaplan-Meier survival probability (%)|97.6||||0.0021|TWO_SIDED|95.0|90.6|99.4||The threshold for significance was 0.05.|z test, 1-sided||The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.|"Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%."||99.4|90.6|0.0021
73940948|NCT04496219|147413926|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||This p value relates to instillation adherence||||0.97
73940949|NCT04496219|147413926|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||This p value relates to missed visits.||||0.17
73940950|NCT04496219|147413927|SUPERIORITY|||||||0.5638|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Constipation Symptoms.||||0.5638
73940951|NCT04496219|147413927|SUPERIORITY|||||||0.1753|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Diarrhea Symptoms.||||0.1753
73940952|NCT04496219|147413927|SUPERIORITY|||||||0.2062|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Urinary Symptoms.||||0.2062
73940953|NCT04496219|147413928|SUPERIORITY|||||||0.8092|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Global Health.||||0.8092
73940954|NCT04496219|147413928|SUPERIORITY|||||||0.5492|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Physical Function.||||0.5492
73940955|NCT04496219|147413928|SUPERIORITY|||||||0.6464|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Emotional Function.||||0.6464
73940956|NCT04496219|147413928|SUPERIORITY|||||||0.586|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Social Function.||||0.586
73940957|NCT04496219|147413928|SUPERIORITY|||||||0.8999|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Fatigue Symptoms.||||0.8999
73940958|NCT04496219|147413928|SUPERIORITY|||||||0.2007|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Pain Symptoms.||||0.2007
73940959|NCT04496219|147413928|SUPERIORITY|||||||0.9921|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Malaise Symptoms.||||0.9921
73940960|NCT04496219|147413928|SUPERIORITY|||||||0.5723|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Role Function.||||0.5723
73940961|NCT04496219|147413928|SUPERIORITY|||||||0.812|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Cognitive Function.||||0.812
73974250|NCT02379351|147493356|NON_INFERIORITY|Likert Scale of Provider Satisfaction|||||<|0.01|||||||Chi-squared|Data analysis will use mostly descriptive statistics: parametric and nonparametric statistics will be used as indicated.|||Likert Scale of Provider Satisfaction|||<0.01
73974251|NCT03373916|147493357|OTHER|||||||0.58|||||||Chi-squared|||||||0.58
74089099|NCT03575871|147731433|SUPERIORITY||Difference in Percentage|9.1||||0.007|TWO_SIDED|95.0|3.4|14.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||14.7|3.4|0.0070
73940962|NCT04496219|147413928|SUPERIORITY|||||||0.96|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Nausea Symptoms.||||0.96
73940963|NCT04496219|147413928|SUPERIORITY|||||||0.1062|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Dyspnoea Symptoms.||||0.1062
73940964|NCT04496219|147413928|SUPERIORITY|||||||0.3259|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Insomnia Symptoms.||||0.3259
73940965|NCT04496219|147413928|SUPERIORITY|||||||0.9664|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Appetite Loss Symptoms.||||0.9664
73940966|NCT04496219|147413928|SUPERIORITY|||||||0.4564|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Finances.||||0.4564
73940967|NCT04496219|147413928|SUPERIORITY|||||||0.1036|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intravesical Symptoms.||||0.1036
73974252|NCT03373916|147493358|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
73974253|NCT03373916|147493359|OTHER|||||||0.18|||||||Chi-squared|||||||0.18
73974254|NCT03373916|147493360|OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
73940968|NCT04496219|147413928|SUPERIORITY|||||||0.1789|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Worries.||||0.1789
73940969|NCT04496219|147413928|SUPERIORITY|||||||0.5186|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Bloating Symptoms.||||0.5186
73940970|NCT04496219|147413928|SUPERIORITY|||||||0.0757|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Sexual Function.||||0.0757
73940971|NCT04496219|147413928|SUPERIORITY|||||||0.1174|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Male Sex Problems.||||0.1174
73940972|NCT04496219|147413928|SUPERIORITY|||||||0.3129|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intimacy.||||0.3129
73940973|NCT00951483|147413930|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-2.65||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that C-reactive protein (CRP) is no different between the experimental and healthy control cohorts at 12 weeks.||||.001
73940974|NCT00951483|147413931|SUPERIORITY_OR_OTHER||z-score|-4.544|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-D-7 score and end of treatment (i.e., 12 week) HAM-D-7 score.||||<.001
73940975|NCT00951483|147413932|SUPERIORITY_OR_OTHER||z-score|-4.627|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-17 score and end of treatment (i.e., 12 week) HAMD-17 score.||||<.001
73940976|NCT00951483|147413933|SUPERIORITY_OR_OTHER||z-score|-4.624|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-21 score and end of treatment (i.e., 12 week) HAMD-21 score.||||<.001
73940977|NCT00951483|147413934|SUPERIORITY_OR_OTHER||z-score|-4.51|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-A score and end of treatment (i.e., 12 week) HAM-A score.||||<.001
73940978|NCT00951483|147413935|SUPERIORITY_OR_OTHER||z-score|-4.435|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline BDI score and end of treatment (i.e., 12 week) BDI score.||||<.001
73940979|NCT00951483|147413936|SUPERIORITY_OR_OTHER||z-score|-3.911|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline PSS-14 score and end of treatment (i.e., 12 week) PSS-14 score.||||<.001
73940980|NCT01570829|147413937|SUPERIORITY|||||||0.0352|||||||Fisher Exact|||||||0.0352
73940981|NCT01570829|147413938|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
73940982|NCT01570829|147413939|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
73974255|NCT03373916|147493361|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
73974256|NCT01830595|147493429|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
73974257|NCT01830595|147493431|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
73974258|NCT01830595|147493432|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
73867478|NCT00235716|147279960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||0.14|TWO_SIDED|95.0|0.11|3.19||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.19|0.11|0.14
73940983|NCT01570829|147413940|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|Breslow-Day test p-value is 0.98||||||0.0001
73940984|NCT01570829|147413941|SUPERIORITY|||||||0.0004||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.0004
73940985|NCT01570829|147413942|SUPERIORITY|||||||0.0004||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.0004
73940986|NCT01570829|147413943|SUPERIORITY|||||||0.67||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with waist circumference data.||||0.67
73940987|NCT01570829|147413943|SUPERIORITY|||||||0.26||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with hip circumference data.||||0.26
73940988|NCT01570829|147413944|SUPERIORITY|||||||0.4||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with Physical Health domain data.||||0.40
73974259|NCT04940624|147493433|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-15.64|||=|0.061|TWO_SIDED|95.0|-31.3|0.24||The p-value was calculated by Rank Analysis of Covariance (ANCOVA) model using treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% confidence interval (CI) were based on the Hodges-Lehmann estimation.|||0.24|-31.30|=0.061
73974260|NCT04940624|147493434|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-14.29|||=|0.089|TWO_SIDED|95.0|-30.51|1.53||The p-value was calculated by the Rank ANCOVA model using treatment group, age stratum (≤6 years, \>6 years), and rank of baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||1.53|-30.51|=0.089
73974261|NCT04940624|147493435|SUPERIORITY||Odds Ratio (OR)|3.22|||=|0.01|TWO_SIDED|95.0|1.3|7.96|||Cochran-Mantel-Haenszel|The p-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by age stratum (≤6 years, \>6 years).||||7.96|1.30|=0.010
74089100|NCT03575871|147731433|SUPERIORITY||Difference in Percentage|9.7||||0.0049|TWO_SIDED|95.0|4.0|15.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.4|4.0|0.0049
73940989|NCT01570829|147413944|SUPERIORITY|||||||0.34||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with Mental Health domain data.||||0.34
73940990|NCT03364751|147413945|OTHER||LS Mean Difference|0.068||||0.297|TWO_SIDED|95.0|-0.06|0.196|||Mixed Models Analysis|||Month 6: Difference between Cigarette and IQOS||0.196|-0.060|0.297
73940991|NCT03364751|147413945|OTHER||LS Mean Difference|-0.064||||0.55|TWO_SIDED|95.0|-0.273|0.146|||Mixed Models Analysis|||Month 6: Difference between Cigarette and Dual Use||0.146|-0.273|0.550
73940992|NCT03364751|147413946|OTHER||LS Mean Difference|0.043||||0.502|TWO_SIDED|95.0|-0.084|0.171|||Mixed Models Analysis|||Month 3: Difference between Cigarette and IQOS||0.171|-0.084|0.502
73940993|NCT03364751|147413946|OTHER||LS Mean Difference|-0.02||||0.851|TWO_SIDED|95.0|-0.229|0.189|||Mixed Models Analysis|||Month 3: Difference between Cigarette and Dual Use||0.189|-0.229|0.851
73940994|NCT03364751|147413947|OTHER||LS Mean Difference|0.07||||0.376|TWO_SIDED|95.0|-0.085|0.224|||Mixed Models Analysis|||Month 3: Difference between Cigarette and IQOS||0.224|-0.085|0.376
73974262|NCT04940624|147493436|SUPERIORITY||Odds Ratio (OR)|3.59|||=|0.008|TWO_SIDED|95.0|1.36|9.49|||Cochran-Mantel-Haenszel|The p-value was based on CMH test stratified by age stratum (≤6 years, \>6 years).||||9.49|1.36|=0.008
74089101|NCT03575871|147731433|SUPERIORITY||Difference in Percentage|22.9|||<|0.0001|TWO_SIDED|95.0|15.5|30.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.2|15.5|<0.0001
73940995|NCT03364751|147413947|OTHER||LS Mean Difference|0.025||||0.848|TWO_SIDED|95.0|-0.229|0.279|||Mixed Models Analysis|||Month 3: Difference between Cigarette and DualUse||0.279|-0.229|0.848
73940996|NCT03364751|147413947|OTHER||LS Mean Difference|0.092||||0.246|TWO_SIDED|95.0|-0.064|0.247|||Mixed Models Analysis|||Month 6: Difference between Cigarette and IQOS||0.247|-0.064|0.246
73940997|NCT03364751|147413947|OTHER||LS Mean Difference|-0.105||||0.417|TWO_SIDED|95.0|-0.359|0.15|||Mixed Models Analysis|||Month 6: Difference between Cigarette and Dual Use||0.150|-0.359|0.417
73940998|NCT02342886|147413972|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% confidence interval (CI) for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was \< 12%.|Treatment difference: unfavourable rate|9.88|||||TWO_SIDED|95.0|-4.13|23.89|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).|||23.89|-4.13|
73940999|NCT02342886|147413973|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was \< 12%.|Treatment difference: unfavourable rate|6.62|||||TWO_SIDED|95.0|-2.15|15.4|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).|||15.40|-2.15|
73974263|NCT04940624|147493438|SUPERIORITY||Odds Ratio (OR)|2.51|||=|0.004|TWO_SIDED|95.0|1.33|4.72|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||4.72|1.33|=0.004
73941000|NCT01163097|147414017|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence of the treatments was assessed using the 90% confidence interval (CI) of the geometric mean ratio for Ki67. The lower bound of the CI needed to be greater than 0.70 and the upper bound needed to be below 1.43 for the treatments to be considered equivalent.|Geometric mean ratio|0.863|||||TWO_SIDED|90.0|0.759|0.982|||ANCOVA|ANCOVA was used to estimate the treatment effect and the Schuirmann's two one-sided test was used to test for statistical equivalence.||H0: mean ratio\<0.7 or mean ratio\>1.43; H1: 0.7\< mean ratio \<1.43 Sample size calculation assumed change in Ki67 expression following palifermin administration would not be affected by co-administration of heparin. With n=26 (13 + 13), an approx. 80% probability that the 90% CI of the ratio of geometric means of Ki67 for palifermin when co-administered with heparin compared to palifermin alone would fall in the interval (0.7, 1.43). This assumed a Coefficient of Variation (CV) for Ki67 of 31%.||0.982|0.759|
73974264|NCT04940624|147493439|SUPERIORITY||Odds Ratio (OR)|2.58|||=|0.003|TWO_SIDED|95.0|1.37|4.87|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||4.87|1.37|=0.003
74031173|NCT03074162|147615886|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|85.56|STANDARD_ERROR_OF_MEAN|42.05|||TWO_SIDED|90.0|74.11|98.77|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/A) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation|||98.77|74.11|
73941001|NCT01163097|147414019|SUPERIORITY_OR_OTHER||Geometric mean|0.737|||||TWO_SIDED|95.0|0.614|0.885|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 20% increase (or 17% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of amylase would be 14% (as observed in other study)||0.885|0.614|
73941002|NCT01163097|147414020|SUPERIORITY_OR_OTHER||Geometric mean|0.373|||||TWO_SIDED|95.0|0.216|0.645|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 70% increase (or 41% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of lipase would be 49% (as observed in other study)||0.645|0.216|
73941003|NCT01163097|147414021|SUPERIORITY_OR_OTHER||Geometric mean|0.972|||||TWO_SIDED|95.0|0.768|1.231|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 140% increase with 13 and 6 subjects (respectively) when Treatment B was compared to Treatment C; assuming that the coefficient of variation of the protein/creatinine ratio would be 67% (Ginsberg et al 1983)||1.231|0.768|
73941004|NCT01163097|147414022|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
73941005|NCT01163097|147414023|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
73941006|NCT01163097|147414024|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
73974265|NCT04940624|147493440|SUPERIORITY||Odds Ratio (OR)|1.12|||=|0.741|TWO_SIDED|95.0|0.56|2.26|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Alertness||2.26|0.56|=0.741
73941007|NCT01163097|147414025|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
73941008|NCT01163097|147414026|SUPERIORITY_OR_OTHER|||||||0.4123||90.0|||||ANOVA|||||||0.4123
73941009|NCT01163097|147414027|SUPERIORITY_OR_OTHER|||||||0.9944||90.0|||||ANOVA|||||||0.9944
73941010|NCT01163097|147414028|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
73941011|NCT01163097|147414029|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
73974266|NCT04940624|147493440|SUPERIORITY||Odds Ratio (OR)|1.04|||=|0.901|TWO_SIDED|95.0|0.54|2.02|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Communication||2.02|0.54|=0.901
73974267|NCT04940624|147493440|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.693|TWO_SIDED|95.0|0.58|2.28|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Disruptive Behaviors||2.28|0.58|=0.693
73974268|NCT04940624|147493441|SUPERIORITY||Least Square Mean Difference|-3.03|||=|0.189|TWO_SIDED|95.0|-7.59|1.52||P-value was based on MMRM analysis with change from baseline as outcome and baseline score as fixed continuous effect; treatment group, age stratum, analysis visit, and analysis visit by treatment group interaction as fixed categorical effects.|MMRM|||||1.52|-7.59|=0.189
73941012|NCT01569438|147414044|OTHER||Mean Difference|-0.7||||0.0734|TWO_SIDED|90.0|-1.6|0.2||one-sided|Mixed Model with Repeated Measures|||MMRM approach was used to model the change from baseline as a function of treatment, week, treatment by week interaction, baseline score, and baseline score by week interaction.||0.2|-1.6|0.0734
73941013|NCT01569438|147414045|OTHER||Mean Difference|-1.0||||0.2726|TWO_SIDED|90.0|-3.9|1.8||one-sided|Mixed Model With Repeated Measures|||MMRM approach was used to model the change from baseline as a function of treatment, week, treatment by week interaction, baseline score, and baseline score by week interaction.||1.8|-3.9|0.2726
73941014|NCT01569438|147414046|OTHER||Mean Difference|-0.3||||0.3603|TWO_SIDED|90.0|-1.7|1.1||one-sided|ANCOVA|||The one-way ANCOVA model was used to calculate change from baseline as a function of treatment and baseline score.||1.1|-1.7|0.3603
73941015|NCT01569438|147414047|OTHER||Mean Difference|-1.5||||0.1183|TWO_SIDED|90.0|-3.5|0.6||one-sided|ANCOVA|||The one-way ANCOVA model was used to calculate change from baseline as a function of treatment and baseline score.||0.6|-3.5|0.1183
73867479|NCT00235716|147279960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.86|TWO_SIDED|95.0|-2.07|1.02||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.02|-2.07|0.86
73941016|NCT01212770|147414071|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|22.3|||<|0.0001|TWO_SIDED|95.0|13.0|31.6|||Cochran-Mantel-Haenszel|Adjusted for baseline disease modifying antirheumatic drug (DMARD) use and and ≥ 3% body surface area (BSA) psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|The percentage of participants with an ACR20 response was compared using a Cochran-Mantel- Haenszel (CMH) test. The Hochberg procedure was used to maintain the Type 1 error at the 0.05 significance level. The results were considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||31.6|13.0|<0.0001
73941017|NCT01212770|147414071|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.8||||0.0295|TWO_SIDED|95.0|1.1|18.6|||Cochran-Mantel-Haenszel|2-sided p-value based on the Cochran-Mantel-Haenszel test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||18.6|1.1|0.0295
73941018|NCT01212770|147414072|SUPERIORITY||LS Mean Difference|-0.127||||0.0073|TWO_SIDED|95.0|-0.22|-0.034|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.034|-0.220|0.0073
73941019|NCT01212770|147414072|SUPERIORITY||LS Mean Difference|-0.066||||0.1619|TWO_SIDED|95.0|-0.158|0.027|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||0.027|-0.158|0.1619
73974269|NCT04940624|147493442|SUPERIORITY||Odds Ratio (OR)|3.65|||<|0.001|TWO_SIDED|95.0|1.87|7.13|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||7.13|1.87|<0.001
73974270|NCT04940624|147493443|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-9.97|||=|0.565|TWO_SIDED|95.0|-29.01|7.87|||ANCOVA|The Rank ANCOVA model used treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||7.87|-29.01|=0.565
73974271|NCT04940624|147493444|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-8.13|||=|0.637|TWO_SIDED|94.0|-26.31|10.13|||ANCOVA|The Rank ANCOVA model used treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||10.13|-26.31|=0.637
73974272|NCT04940624|147493445|SUPERIORITY||Least Square Mean Difference|0.79|||||TWO_SIDED|95.0|-3.81|5.4|||||A linear model with treatment group and age stratum as factors and baseline percentage as a covariate was used for analysis.|||5.40|-3.81|
73974273|NCT04940624|147493446|SUPERIORITY||Least Square Mean Difference|5.6|||||TWO_SIDED|95.0|0.1|11.2||||||||11.2|0.1|
74039426|NCT04847141|147632419|SUPERIORITY||LS Mean Difference|0.01||||0.9485|TWO_SIDED|95.0|-0.38|0.4|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.40|-0.38|0.9485
73867480|NCT00235716|147279960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.17||||0.03|TWO_SIDED|95.0|-3.71|-0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.63|-3.71|0.03
73867481|NCT00235716|147279961|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.31|TWO_SIDED|95.0|0.67|1.13||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for vitamin E group relative to the placebo group.|||1.13|0.67|0.31
73974274|NCT04940624|147493447|SUPERIORITY||Least Square Mean Difference|-1.1|||||TWO_SIDED|95.0|-3.1|1.0|||||Least square mean difference was estimated using a linear model with treatment group and age stratum as factors.|||1.0|-3.1|
73867482|NCT00235716|147279961|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.47|TWO_SIDED|95.0|0.91|1.24||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the memantine group relative to the placebo group.|||1.24|0.91|0.47
73941020|NCT01212770|147414073|SUPERIORITY||Adjusted Difference|15.5||||0.0007|TWO_SIDED|95.0|6.7|24.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||24.3|6.7|0.0007
73941021|NCT01212770|147414073|SUPERIORITY||Adjusted Difference|11.1||||0.011|TWO_SIDED|95.0|2.7|19.5||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||19.5|2.7|0.0110
73941022|NCT01212770|147414074|SUPERIORITY||LS Mean Difference|-0.139||||0.005|TWO_SIDED|95.0|-0.236|-0.042|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-0.042|-0.236|0.0050
73974275|NCT05648890|147493476|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between MMSE and TEGEST test before operation.||||<0.0001
73941023|NCT01212770|147414074|SUPERIORITY||LS Mean Difference|-0.084||||0.086|TWO_SIDED|95.0|-0.181|0.012|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||0.012|-0.181|0.0860
73974276|NCT05648890|147493477|OTHER|Spearman's ran correlation coefficient was used .|||||<|0.001|||||||Spearman's ran correlation coefficient|Spearman's ran correlation coefficient was used for correlation between two quantities.||Correlation between MMSE and TEGEST after operation||||< .001
73867483|NCT00235716|147279961|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8|TWO_SIDED|95.0|0.57|1.54||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the vitamin E + memantine group relative to the placebo group.|||1.54|0.57|0.80
73867484|NCT03036189|147279966|SUPERIORITY||Slope|-0.15||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
73867485|NCT03036189|147279967|SUPERIORITY||Slope|0.42||||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
73867486|NCT03036189|147279968|SUPERIORITY||Slope|0.12||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
73867487|NCT03036189|147279969|SUPERIORITY||Slope|0.37||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
73867488|NCT03036189|147279970|SUPERIORITY||Slope|-0.4||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
73867489|NCT03036189|147279971|SUPERIORITY||Slope|0.49||||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
73867490|NCT03036189|147279972|SUPERIORITY||Slope|-0.03||||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
73867491|NCT03036189|147279973|SUPERIORITY||Slope|0.45||||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
73867492|NCT03036189|147279974|SUPERIORITY||Slope|0.25||||0.77|TWO_SIDED||||||Mixed Models Analysis|||||||0.77
73867493|NCT03036189|147279975|SUPERIORITY||Slope|0.54|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
73867494|NCT03036189|147279976|SUPERIORITY||Slope|1.99||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
73867495|NCT03036189|147279977|SUPERIORITY||Slope|1.05||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
73867496|NCT03036189|147279978|SUPERIORITY||Slope|2.0||||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
73867497|NCT03036189|147279979|SUPERIORITY||Slope|-23.01||||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
73867498|NCT01124955|147279986|SUPERIORITY_OR_OTHER||||||,|0|||||||ANOVA|||||||0,05
73867499|NCT03274518|147279992|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.4534|||||||t-test, 2 sided|||||||0.4534
73867500|NCT03274518|147279993|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.1179|||||||t-test, 2 sided|||||||0.1179
73867501|NCT03274518|147279994|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.3054|||||||t-test, 2 sided|||||||0.3054
73867502|NCT03274518|147279995|NON_INFERIORITY|The lower the ECW/TBW ratio, the lower pre-dialysis excess fluid. A non-inferiority margin was defined as difference within 10% from reference method (olHDF)||||||0.045|||||||t-test, 2 sided|||||||0.045
73867503|NCT03916484|147280006|OTHER|||||||0.33||||||No a priori threshold for statistical significance was specified.|Kruskal-Wallis|||||||0.33
73867504|NCT03916484|147280007|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
73867505|NCT03916484|147280007|OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
73867506|NCT03916484|147280007|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
73867507|NCT03916484|147280007|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
73867508|NCT03916484|147280007|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
73867509|NCT03916484|147280008|OTHER|||||||0.45||||||No a priori threshold for statistical significance was specified.|Fisher Exact|||||||0.45
73867510|NCT03916484|147280009|OTHER||||||<|0.001|||||||McNemar|||||||<0.001
73867511|NCT03916484|147280009|OTHER|||||||0.07|||||||McNemar|||||||0.07
73867512|NCT03916484|147280009|OTHER|||||||0.003|||||||McNemar|||||||0.003
73867513|NCT03916484|147280010|OTHER|||||||0.25|||||||McNemar|||||||0.25
73867514|NCT03916484|147280010|OTHER|||||||0.002|||||||McNemar|||||||0.002
73867515|NCT03916484|147280010|OTHER|||||||0.453|||||||McNemar|||||||0.453
73867516|NCT03916484|147280010|OTHER|||||||0.5|||||||McNemar|||||||0.500
73867517|NCT03916484|147280010|OTHER|||||||0.003|||||||McNemar|||||||0.003
73867518|NCT00148941|147280080|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% confidence intervals (CIs) for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.97|||||TWO_SIDED|95.0|0.871|1.08|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.080|0.871|
73867519|NCT00148941|147280080|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.961|||||TWO_SIDED|95.0|0.863|1.07|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.070|0.863|
73974277|NCT05648890|147493478|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between TEGEST and Clock drawing test before operation.|Spearman's rank correlation coefficient was used.|||<0.0001
73974278|NCT05648890|147493479|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.001|||||||Spearman's rank correlation coefficient|||Correlation between TEGEST and clock drawing test after operation.||||<0.001
73974279|NCT05648890|147493480|OTHER|Spearman's rank correlation coefficient.|||||<|0.001|||||||Spearman's rank correlation coefficien|||Correlation between MMSE and Clock drawing test before operation.||||<0.001
73974280|NCT05648890|147493480|OTHER|Mann-Whitney U test before operation.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Clock drawing before operation.||||0.023
73974281|NCT05648890|147493481|OTHER|Spearman's rank correlation coefficient|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between Clock drawing test and MMSE after operation.||||<0.0001
73974282|NCT05648890|147493482|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with MMSE before operation.||||<0.0001
73974283|NCT05648890|147493482|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with TEGEST before operation.||||<0.0001
73974284|NCT05648890|147493482|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with Clock drawing test before operation.||||<0.0001
73974285|NCT05648890|147493483|OTHER|Mann-Whitney U test.||||||0.562|||||||Wilcoxon (Mann-Whitney)|||Respondents living at a house or in apartment and relationships with Clinical frailty scale.||||.562
73974286|NCT05648890|147493484|OTHER|Mann-Whitney test was used.||||||0.129|||||||Wilcoxon (Mann-Whitney)|||Respondents living with with family or alone and relationship with Clinical frailty scale.||||0.129
73974287|NCT05648890|147493485|OTHER|Mann-Whintney test was used.||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Relationship between respondents living at home with stairs and respondents living at home with an elevator and Clinical frailty scale.||||0.019
73974288|NCT04977583|147493606|SUPERIORITY||Odds Ratio (OR)|1.138|STANDARD_ERROR_OF_MEAN|0.2625||0.6243|TWO_SIDED|95.0|0.679|1.904|||Mixed Models Analysis|||This test is comparing Arm 1 (screening) to Arm 2 (awareness)||1.904|0.679|0.6243
73974289|NCT04977583|147493606|SUPERIORITY||Odds Ratio (OR)|1.497|STANDARD_ERROR_OF_MEAN|0.2553||0.1146|TWO_SIDED|95.0|0.908|2.469|||Mixed Models Analysis|||This test compares Arm 1 (screening) to arm 3 (assistance)||2.469|0.908|0.1146
73974290|NCT04977583|147493607|SUPERIORITY||Risk Ratio (RR)|0.963|STANDARD_ERROR_OF_MEAN|0.2078||0.856|TWO_SIDED|95.0|0.641|1.447|||Poisson|We used total needs as an offset||This test is comparing Arm 1 (screening) to Arm 2 (awareness)||1.447|0.641|0.856
73974291|NCT04977583|147493607|SUPERIORITY||Risk Ratio (RR)|1.136|STANDARD_ERROR_OF_MEAN|0.1999||0.5248|TWO_SIDED|95.0|0.768|1.681|||Poisson|||This test is comparing Arm 1 (screening) to Arm 3 (assistance)||1.681|0.768|0.5248
73974292|NCT04977583|147493608|SUPERIORITY||Odds Ratio (OR)|0.866|STANDARD_ERROR_OF_MEAN|0.22||0.5582|TWO_SIDED|95.0|0.536|1.4|||Regression, Logistic|||This is Arm 1 compared to Arm 2||1.400|0.536|.5582
73974293|NCT04977583|147493608|SUPERIORITY||Odds Ratio (OR)|0.854|STANDARD_ERROR_OF_MEAN|0.217||0.5196|TWO_SIDED|95.0|0.528|1.381|||Regression, Logistic|||This is Arm 1 compared to Arm 3||1.381|0.528|0.5196
73974294|NCT04977583|147493609|SUPERIORITY||Odds Ratio (OR)|1.42|STANDARD_ERROR_OF_MEAN|0.2794||0.2105|TWO_SIDED|95.0|0.821|2.454|||ANOVA|||This is arm 1 compared to arm 2||2.454|0.821|0.2105
73974295|NCT04977583|147493609|SUPERIORITY||Odds Ratio (OR)|0.7944|STANDARD_ERROR_OF_MEAN|0.2816||0.4143|TWO_SIDED|95.0|0.4574|1.379|||ANOVA|||This is arm 1 compared to arm 3||1.379|0.4574|.4143
73974296|NCT04977583|147493610|SUPERIORITY||Odds Ratio (OR)|0.9995|STANDARD_ERROR_OF_MEAN|0.0171||0.9775|TWO_SIDED|95.0|0.9665|1.0336|||ANOVA|||This arm 1 compared to arm 2||1.0336|0.9665|0.9775
73974297|NCT04977583|147493610|SUPERIORITY||Odds Ratio (OR)|1.017|STANDARD_ERROR_OF_MEAN|0.0176||0.3194|TWO_SIDED|95.0|0.9832|1.0534|||ANOVA|||This arm 1 compared to arm 3||1.0534|0.9832|0.3194
73974298|NCT04977583|147493611|SUPERIORITY||Odds Ratio (OR)|1.0284|STANDARD_ERROR_OF_MEAN|0.1613||0.8623|TWO_SIDED|95.0|0.7497|1.4107|||ANOVA|||This is arm 1 compared to arm 2||1.4107|0.7497|0.8623
73974299|NCT04977583|147493611|SUPERIORITY||Odds Ratio (OR)|1.3701|STANDARD_ERROR_OF_MEAN|0.1626||0.0534|TWO_SIDED|95.0|0.9962|1.8844|||ANOVA|||This is arm 1 compared to arm 3||1.8844|0.9962|0.0534
73974300|NCT04977583|147493612|SUPERIORITY||Odds Ratio (OR)|2.298|STANDARD_ERROR_OF_MEAN|1.464||0.5701|TWO_SIDED|95.0|0.1304|40.5121|||ANOVA|||This is arm 1 compared to arm 2||40.5121|0.1304|0.5701
73974301|NCT04977583|147493612|SUPERIORITY||Odds Ratio (OR)|4.56|STANDARD_ERROR_OF_MEAN|1.467||0.3016|TWO_SIDED|95.0|0.2571|80.8746|||ANOVA|||This is arm 1 compared to arm 3||80.8746|0.2571|0.3016
73974302|NCT04977583|147493613|SUPERIORITY||Odds Ratio (OR)|1.522|STANDARD_ERROR_OF_MEAN|0.2438||0.087|TWO_SIDED|95.0|0.944|2.454|||ANOVA|||This is arm 1 compared to arm 2||2.454|0.944|0.0870
73941024|NCT01212770|147414075|SUPERIORITY||LS Mean Difference|2.32||||0.0053|TWO_SIDED|95.0|0.69|3.95|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||3.95|0.69|0.0053
73941025|NCT01212770|147414075|SUPERIORITY||LS mean Difference|1.15||||0.1658|TWO_SIDED|95.0|-0.48|2.77|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||2.77|-0.48|0.1658
73974303|NCT04977583|147493613|SUPERIORITY||Odds Ratio (OR)|1.85|STANDARD_ERROR_OF_MEAN|0.2897||0.0354|TWO_SIDED|95.0|1.048|3.264|||ANOVA|||This is arm 1 compared to arm 3||3.264|1.048|0.0354
73974304|NCT04977583|147493614|SUPERIORITY||Odds Ratio (OR)|0.618|STANDARD_ERROR_OF_MEAN|0.333||0.3063|TWO_SIDED|95.0|0.246|1.553|||ANOVA|||This is arm 1 compared to arm 2||1.553|0.246|0.3063
73974305|NCT04977583|147493614|SUPERIORITY||Odds Ratio (OR)|0.679|STANDARD_ERROR_OF_MEAN|0.3946||0.4378|TWO_SIDED|95.0|0.256|1.803|||ANOVA|||This is arm 1 compared to arm 3||1.803|.256|.4378
73974306|NCT04977583|147493615|SUPERIORITY||Odds Ratio (OR)|0.5083|STANDARD_ERROR_OF_MEAN|0.8265||0.4134|TWO_SIDED|95.0|0.1006|2.5687|||ANOVA|||This is arm 1 compared to arm 2||2.5687|0.1006|0.4134
73974307|NCT04977583|147493615|SUPERIORITY||Odds Ratio (OR)|1.819|STANDARD_ERROR_OF_MEAN|0.8283||0.4705|TWO_SIDED|95.0|0.3588|9.223|||ANOVA|||This is arm 1 compared to arm 3||9.2230|0.3588|0.4705
73974308|NCT04977583|147493616|SUPERIORITY||Odds Ratio (OR)|1.765|STANDARD_ERROR_OF_MEAN|0.2684||0.0347|TWO_SIDED|95.0|1.044|2.987|||Mixed Models Analysis||This analysis is arm 1 compared to arm 3. Arm 3 is the numerator and arm 1 is the denominator.|||2.987|1.044|0.0347
73974309|NCT04977583|147493617|SUPERIORITY||Odds Ratio (OR)|1.734|STANDARD_ERROR_OF_MEAN|0.3489||0.116|TWO_SIDED|95.0|0.875|3.436|||Mixed Models Analysis||This analysis compares arm 1 to arm 2. Arm 2 is the numerator and Arm 1 is the denominator|||3.436|0.875|0.1160
73974310|NCT04977583|147493617|SUPERIORITY||Odds Ratio (OR)|2.376|STANDARD_ERROR_OF_MEAN|0.3475||0.0134|TWO_SIDED|95.0|1.202|4.695|||Mixed Models Analysis|||||4.695|1.202|0.0134
73974311|NCT04977583|147493618|SUPERIORITY||Odds Ratio (OR)|5.006|STANDARD_ERROR_OF_MEAN|0.617||0.0094|TWO_SIDED|95.0|1.512|16.57|||Mixed Models Analysis||This analysis is arm 1 compared to compared to arm 3. Arm 3 is the numerator and arm 1 is denominator.|||16.570|1.512|0.0094
73974312|NCT04977583|147493618|SUPERIORITY||Odds Ratio (OR)|1.875|STANDARD_ERROR_OF_MEAN|0.6532||0.3377|TWO_SIDED|95.0|0.521|6.746|||Mixed Models Analysis||This is a comparison of arm 1 and arm 2. Arm 2 is the numerator and arm 1 is the denominator.|||6.746|0.521|0.3377
73974313|NCT02422615|147493619|SUPERIORITY||Cox Proportional Hazard|0.593||||4.1e-07|TWO_SIDED|95.0|0.48|0.732|||Log Rank|||||0.732|0.480|0.00000041
73974314|NCT02422615|147493620|SUPERIORITY||Cox Proportional Hazard|0.724||||0.00455|TWO_SIDED|95.0|0.568|0.924|||Log Rank|||||0.924|0.568|0.00455
73974315|NCT02422615|147493621|SUPERIORITY||Cox Proportional Hazard|0.492|||||TWO_SIDED|95.0|0.345|0.703||||||||0.703|0.345|
73974316|NCT04098575|147493640|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73974317|NCT04098575|147493641|OTHER|||||||0.835|||||||Chi-squared|||||||0.835
73974318|NCT04098575|147493642|OTHER||||||<|0.001|||||||Chi-squared|||Antihypertensive drugs||||<0.001
73974319|NCT04098575|147493642|OTHER||||||<|0.001|||||||Chi-squared|||Lipid-lowering agents||||<0.001
73974320|NCT04098575|147493642|OTHER||||||<|0.001|||||||Chi-squared|||Antiplatelet, anticoagulant drugs||||<0.001
73974321|NCT04098575|147493642|OTHER||||||<|0.001|||||||Chi-squared|||Glucose-lowering therapies||||<0.001
73974322|NCT04098575|147493643|OTHER||||||<|0.001|||||||Chi-squared|||Group: \< 65||||<0.001
73974323|NCT04098575|147493643|OTHER|||||||0.001|||||||Chi-squared|||Group: 65 ≤ 75||||0.001
73974324|NCT04098575|147493643|OTHER||||||<|0.001|||||||Chi-squared|||Group: 75 - 80||||<0.001
73974325|NCT04098575|147493643|OTHER||||||<|0.002|||||||Chi-squared|||Group: \> 80||||<0.002
73974326|NCT04098575|147493644|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73974327|NCT04098575|147493645|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
73974328|NCT04098575|147493646|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
73974329|NCT04098575|147493647|OTHER|||||||0.475|||||||Wilcoxon rank sum test|||||||0.475
73974330|NCT04098575|147493648|OTHER|||||||0.475|||||||Wilcoxon rank sum test|||||||0.475
73974331|NCT04098575|147493649|OTHER||||||<|0.001|||||||Chi-squared|||Insulin||||<0.001
73974332|NCT04098575|147493649|OTHER||||||<|0.001|||||||Chi-squared|||Metformin||||<0.001
73974333|NCT04098575|147493649|OTHER|||||||0.157|||||||Chi-squared|||Acarbose||||0.157
73974334|NCT04098575|147493649|OTHER||||||<|0.001|||||||Chi-squared|||Sulfonylurea||||<0.001
73974335|NCT04098575|147493649|OTHER|||||||0.071|||||||Chi-squared|||Dipeptidyl peptidase-4 (DPP-4) inhibitors||||0.071
73974336|NCT04098575|147493649|OTHER|||||||0.317|||||||Chi-squared|||Glucagon-like peptide-1 (GLP-1) agonists||||0.317
73974337|NCT04098575|147493649|OTHER||||||<|0.001|||||||Chi-squared|||Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin||||<0.001
73974338|NCT04098575|147493650|OTHER||||||<|0.002|||||||Chi-squared|||||||<0.002
73974339|NCT04098575|147493653|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.000
73974340|NCT05288348|147493710|SUPERIORITY||Mean Difference (Final Values)|2.57||||0.56|TWO_SIDED|95.0|-6.19|11.33||unadjusted|Mixed Models Analysis|Mixed methods ANOVA||||11.33|-6.19|0.56
73974341|NCT05288348|147493710|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.92|TWO_SIDED|95.0|-10.5|9.48|||Mixed Models Analysis|Mixed methods ANOVA||Adjusted for age, sex, respiratory rate and injury type||9.48|-10.5|0.92
73974342|NCT05288348|147493711|SUPERIORITY||Mean Difference (Final Values)|-7.14||||0.18|TWO_SIDED|95.0|-17.66|3.37|||Mixed Models Analysis|Mixed effects ANOVA||VNRS @ 60min||3.37|-17.66|0.18
73974343|NCT05288348|147493711|SUPERIORITY||Median Difference (Final Values)|2.92||||0.63|TWO_SIDED|95.0|-9.3|15.1|||Mixed Models Analysis|Mixed effects ANOVA||VNRS @ 60 min Adjusted for sex and injury type||15.10|-9.30|0.63
73941026|NCT01212770|147414076|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|25.4|||<|0.0001|TWO_SIDED|95.0|15.5|35.3|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||35.3|15.5|<0.0001
73867520|NCT00148941|147280080|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.991|||||TWO_SIDED|95.0|0.89|1.103|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.103|0.890|
73867521|NCT00148941|147280080|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.975|||||TWO_SIDED|95.0|0.866|1.097|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.097|0.866|
73867522|NCT00148941|147280080|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.878|||||TWO_SIDED|95.0|0.78|0.988|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||0.988|0.780|
73867523|NCT00148941|147280080|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.901|||||TWO_SIDED|95.0|0.8|1.014|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.014|0.800|
73867524|NCT00148941|147280081|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.938|||||TWO_SIDED|95.0|0.828|1.063|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.063|0.828|
73867525|NCT00148941|147280081|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.963|||||TWO_SIDED|95.0|0.85|1.091|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.091|0.850|
73941027|NCT01212770|147414076|SUPERIORITY||Adjusted Difference|10.4||||0.0372|TWO_SIDED|95.0|0.8|20.0|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||20.0|0.8|0.0372
73974344|NCT05288348|147493711|SUPERIORITY||Mean Difference (Final Values)|-10.59||||0.08|TWO_SIDED|95.0|-22.39|1.21||Unadjusted|Mixed Models Analysis|||VNRS @ 90 min||1.21|-22.39|0.08
73974345|NCT05288348|147493711|SUPERIORITY||Mean Difference (Final Values)|7.36||||0.28|TWO_SIDED|95.0|-6.13|20.8|||Mixed Models Analysis|Mixed Method ANOVA|Adjusted for ISS|VNRS @90min adjusted||20.80|-6.13|0.28
73974346|NCT05288348|147493711|SUPERIORITY||Mean Difference (Final Values)|-9.52||||0.18|TWO_SIDED|95.0|-23.6|4.56|||Mixed Models Analysis|||VNRS @ 120 min||4.56|-23.60|0.18
73974347|NCT05288348|147493711|SUPERIORITY||Mean Difference (Final Values)|-5.24||||0.5|TWO_SIDED|95.0|-20.7|10.2|||Mixed Models Analysis|Mixed Method ANOVA||VNRS @ 120min adjusted for sex, HR, RR, and injury type||10.20|-20.70|0.50
73974348|NCT05288348|147493712|SUPERIORITY|||||||0.005||||||PGA @ 30 min|Chi-squared|||||||0.005
73974349|NCT05288348|147493713|SUPERIORITY||Odds Ratio (OR)|1.45||||0.39|TWO_SIDED|95.0|-4.77|1.89|||General Addative Model|||"SPID 30~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||1.89|-4.77|0.39
73867526|NCT00148941|147280081|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.026|||||TWO_SIDED|95.0|0.906|1.162|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.162|0.906|
73867527|NCT00148941|147280081|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.874|||||TWO_SIDED|95.0|0.783|0.976|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||0.976|0.783|
73867528|NCT00148941|147280081|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.947|||||TWO_SIDED|95.0|0.849|1.057|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.057|0.849|
73867529|NCT00148941|147280081|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.084|||||TWO_SIDED|95.0|0.971|1.209|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.209|0.971|
73867530|NCT00148941|147280081|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.998|||||TWO_SIDED|95.0|0.867|1.148|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.148|0.867|
73867531|NCT00148941|147280081|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.043|||||TWO_SIDED|95.0|0.907|1.2|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.200|0.907|
73867532|NCT00148941|147280081|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.045|||||TWO_SIDED|95.0|0.909|1.202|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.202|0.909|
73867533|NCT00148941|147280082|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.994|||||TWO_SIDED|95.0|0.836|1.181|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.181|0.836|
73867534|NCT00148941|147280082|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.987|||||TWO_SIDED|95.0|0.831|1.172|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.172|0.831|
73974350|NCT05288348|147493713|SUPERIORITY||Odds Ratio (OR)|1.72||||0.29|TWO_SIDED|95.0|-1.5|4.95|||General Additive Model|||"SPID 30, Adjusted Analysis~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||4.95|-1.50|0.29
73974351|NCT05288348|147493713|SUPERIORITY||Odds Ratio (OR)|0.08||||0.98|TWO_SIDED|95.0|-6.63|6.47|||Generalized Additive Model|||SPID @ 60min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||6.47|-6.63|0.98
74039427|NCT04847141|147632419|SUPERIORITY||LS Mean Difference|0.14||||0.4734|TWO_SIDED|95.0|-0.25|0.54|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.54|-0.25|0.4734
73867535|NCT00148941|147280082|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.993|||||TWO_SIDED|95.0|0.836|1.18|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.180|0.836|
73974352|NCT05288348|147493713|SUPERIORITY||Odds Ratio (OR)|0.61||||0.85|TWO_SIDED|95.0|-5.76|6.98|||Generalized Additive Model|||"SPID 60 Adjusted~Last observed carried forward to address missingness"||6.98|-5.76|0.85
73974353|NCT05288348|147493713|SUPERIORITY||Odds Ratio (OR)|-1.26||||0.8|TWO_SIDED|95.0|-8.75|11.28|||Generalized Additive Model|||SPID @ 90 mn last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||11.28|-8.75|0.8
73974354|NCT05288348|147493713|SUPERIORITY||Odds Ratio (OR)|-0.44||||0.92|TWO_SIDED|95.0|-10.2|9.92|||Generalized Additive Model|||"SPID 90 min Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||9.92|-10.2|0.92
73974355|NCT05288348|147493713|SUPERIORITY||Odds Ratio (OR)|-3.18||||0.64|TWO_SIDED|95.0|-10.45|16.9|||Generalized Additive Model|||SPID @ 120 min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||16.90|-10.45|0.64
73974356|NCT05288348|147493713|SUPERIORITY||Odds Ratio (OR)|-2.15||||0.75|TWO_SIDED|95.0|-15.6|11.3|||Generalized Additive Model|||"SPID 120 Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||11.30|-15.60|0.75
73974357|NCT05288348|147493714|SUPERIORITY||z statistic|0.46||||0.64|TWO_SIDED|95.0|-1.96|1.96|||two sided test of proportion|||||1.96|-1.96|0.64
73867536|NCT00148941|147280082|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.118|||||TWO_SIDED|95.0|0.951|1.314|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.314|0.951|
73867537|NCT00148941|147280082|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.006|||||TWO_SIDED|95.0|0.856|1.183|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.183|0.856|
73867538|NCT00148941|147280082|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\] for Anti-poliovirus type 2.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.765|1.06|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.060|0.765|
73867539|NCT00148941|147280082|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.112|||||TWO_SIDED|95.0|0.941|1.314|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.314|0.941|
73867540|NCT00148941|147280082|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.034|||||TWO_SIDED|95.0|0.876|1.22|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.220|0.876|
73867541|NCT00148941|147280082|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.93|||||TWO_SIDED|95.0|0.787|1.099|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.099|0.787|
73974358|NCT05288348|147493715|SUPERIORITY||Odds Ratio (OR)|-0.22||||0.61|TWO_SIDED|95.0|-1.11|0.66|||General Additive Models|||||0.66|-1.11|0.61
73974359|NCT05288348|147493715|SUPERIORITY||Odds Ratio (OR)|-0.28||||0.54|TWO_SIDED|95.0|-1.23|0.65|||General Additive Model|||6 item screener adjusted analysis||0.65|-1.23|0.54
73974360|NCT05288348|147493716|SUPERIORITY||Odds Ratio (OR)|2.35||||0.009|TWO_SIDED|95.0|1.24|4.46|||Ordinal Polytomous Logisitic Regression|||Healthcare Professional Global Assessment of method of pain control at 30 min.||4.46|1.24|0.009
73974361|NCT05288348|147493716|SUPERIORITY||Odds Ratio (OR)|2.24||||0.01|TWO_SIDED|95.0|1.18|4.29|||Ordinal polytomous logistic regression|||Healthcare Professional Global Assessment of method of pain control at 30 min. adjusted for ISS and Race||4.29|1.18|0.01
73974362|NCT05288348|147493717|SUPERIORITY||Odds Ratio (OR)|0.97||||0.96|TWO_SIDED|95.0|0.22|4.26|||Regression, Logistic|||||4.26|0.22|0.96
73974363|NCT05288348|147493717|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.17|5.04|||||Adjusted for age, sex and SpO2|||5.04|0.17|
73974364|NCT05288348|147493718|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.04|24.92||||||||24.92|0.04|
73974365|NCT05288348|147493718|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.0|14.28|||||Adjusted for Heart Rate and Injury Severity Score|||14.28|0|
73974366|NCT05288348|147493719|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|0.39|8.37||||||||8.37|0.39|
73974367|NCT05288348|147493719|SUPERIORITY||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.39|8.6|||||Adjusted for SpO2|||8.60|0.39|
73974368|NCT05288348|147493721|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.02|5.12||||||||5.12|0.02|
73974369|NCT05288348|147493721|SUPERIORITY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.02|4.56|||||Adjusted for heart rate|||4.56|0.02|
73974370|NCT05288348|147493722|SUPERIORITY||difference of proportion|0.135|||>|0.99|TWO_SIDED||||||Chi-squared|||||||>0.99
73974371|NCT05288348|147493723|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9|TWO_SIDED|95.0|0.69|1.61|||Regression, Cox|||||1.61|0.69|0.90
73974372|NCT05288348|147493723|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.48|TWO_SIDED|95.0|0.75|1.81|||Regression, Cox|||Adjusted for Race and ISS||1.81|0.75|0.48
73867542|NCT00148941|147280082|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ration|0.792|||||TWO_SIDED|95.0|0.68|0.922|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 1 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.922|0.680|
73867543|NCT00148941|147280082|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.802|||||TWO_SIDED|95.0|0.696|0.925|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 2 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.925|0.696|
73974373|NCT05288348|147493725|SUPERIORITY||Odds Ratio (OR)|0.0||||0.99|TWO_SIDED|95.0|-0.15|0.15|||Non parametric General Addative Model|||||0.15|-0.15|0.99
73974374|NCT05288348|147493725|SUPERIORITY||Odds Ratio (OR)|0.01||||0.96|TWO_SIDED|95.0|-0.16|0.15|||Non Parametric General Additive Model|||Adjusted||0.15|-0.16|0.96
74089102|NCT03575871|147731433|SUPERIORITY||Difference in Percentage|14.6||||0.0013|TWO_SIDED|95.0|7.2|22.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||22.0|7.2|0.0013
74089103|NCT03575871|147731433|SUPERIORITY||Difference in Percentage|31.6|||<|0.0001|TWO_SIDED|95.0|23.1|40.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.1|23.1|<0.0001
74089104|NCT03575871|147731433|SUPERIORITY||Difference in Percentage|20.1||||0.0001|TWO_SIDED|95.0|11.9|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.3|11.9|0.0001
73974375|NCT05288348|147493726|SUPERIORITY||Odds Ratio (OR)|0.01||||0.84|TWO_SIDED|95.0|-0.17|0.16|||Non Parametric General Additive Model|||||0.16|-0.17|0.84
73974376|NCT05288348|147493726|SUPERIORITY||Odds Ratio (OR)|0.02||||0.84|TWO_SIDED|95.0|-0.19|0.16|||Non Parametric Generalized Additive Mode|||Adjusted||0.16|-0.19|0.84
73974377|NCT05288348|147493727|SUPERIORITY||Odds Ratio (OR)|0.02||||0.81|TWO_SIDED|95.0|-0.17|0.22|||Non Parametric Generalized Additive Mode|||||0.22|-0.17|0.81
73974378|NCT05288348|147493727|SUPERIORITY||Odds Ratio (OR)|0.01||||0.91|TWO_SIDED|95.0|-0.2|0.22|||Non Parametric Generalized Additive Mode|||Adjusted||0.22|-0.20|0.91
73974379|NCT05288348|147493728|SUPERIORITY||Odds Ratio (OR)|0.03||||0.74|TWO_SIDED|95.0|-0.25|0.18|||Non Parametric Generalized Additive Mode|||||0.18|-0.25|0.74
74089105|NCT03575871|147731433|SUPERIORITY||Difference in Percentage|33.5|||<|0.0001|TWO_SIDED|95.0|24.6|42.5|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.5|24.6|<0.0001
74089106|NCT03575871|147731434|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.7|3.7||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.7|-3.7|
74089107|NCT03575871|147731434|SUPERIORITY||Difference in Percentage|1.3||||0.3261|TWO_SIDED|95.0|-2.8|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-2.8|0.3261
74089108|NCT03575871|147731434|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-2.7|0.3207
74089109|NCT03575871|147731434|SUPERIORITY||Difference in Percentage|3.9||||0.081|TWO_SIDED|95.0|-0.8|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.5|-0.8|0.0810
73974380|NCT05288348|147493728|SUPERIORITY||Odds Ratio (OR)|0.05||||0.63|TWO_SIDED|95.0|-0.3|0.18|||Non Parametric Generalized Additive Mode|||Adjusted||0.18|-0.30|0.63
73974381|NCT03213457|147493735|SUPERIORITY||Odds Ratio (OR)|5.51|||<|0.001|TWO_SIDED|95.0|3.711|8.176||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||8.176|3.711|< 0.001
73867544|NCT00148941|147280082|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.938|||||TWO_SIDED|95.0|0.811|1.085|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 3 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.085|0.811|
73867545|NCT00148941|147280083|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.47|||||TWO_SIDED|95.0|-0.98|1.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of diphtheria toxoid (D) booster responses (i.e measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.21|-0.98|
73867546|NCT00148941|147280083|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-2.81|||||TWO_SIDED|95.0|-6.55|-0.09||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of tetanus toxoid (T) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|-0.09|-6.55|
73867547|NCT00148941|147280084|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.36|||||TWO_SIDED|95.0|-3.83|3.71||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertussis toxoid (PT) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|3.71|-3.83|
73941028|NCT01212770|147414077|SUPERIORITY||Adjusted Difference|14.6||||0.0062|TWO_SIDED|95.0|4.5|24.8|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||24.8|4.5|0.0062
73974382|NCT03213457|147493735|SUPERIORITY||Odds Ratio (OR)|4.33|||<|0.001|TWO_SIDED|95.0|2.968|6.331||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 12||6.331|2.968|< 0.001
73974383|NCT03213457|147493736|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.001|TWO_SIDED|95.0|1.275|2.605||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||2.605|1.275|< 0.001
73974384|NCT03213457|147493736|SUPERIORITY||Odds Ratio (OR)|1.63||||0.007|TWO_SIDED|95.0|1.146|2.326||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 12||2.326|1.146|0.007
73974385|NCT03213457|147493737|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.094|<|0.001|TWO_SIDED|95.0|-1.18|-0.809||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|mixed model repeated measures (MMRM)|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.809|-1.180|< 0.001
73867548|NCT00148941|147280084|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.79|||||TWO_SIDED|95.0|-2.5|3.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of filamentous haemagglutinin (FHA) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|3.21|-2.50|
73867549|NCT00148941|147280084|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-0.82|||||TWO_SIDED|95.0|-3.79|1.14||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertactin (PRN) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.14|-3.79|
73867550|NCT00148941|147280085|NON_INFERIORITY|Non-inferiority objective was considered demonstrated, when the upper limit of the 95% CI for the difference between groups (SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups minus Infanrix + IPOL + M-M-R Group) in percentage of subjects reporting increased circumferential swelling was equal or less than 2%.|Difference in percentage|-0.41|||||TWO_SIDED|95.0|-1.26|0.16||||||Non-inferiority of the SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of the incidence of increased circumferential swelling at the SB213503 and Infanrix injection site, defined as an injection site swelling diameter that involves \> 50% of the length of the upper arm that also is associated with a \> 30 mm increase of the mid-upper arm circumference compared to the baseline measurement.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.16|-1.26|
73867551|NCT01092663|147280105|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
73867552|NCT01092663|147280106|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
73867553|NCT01092663|147280107|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effects between the 2 groups||||>0.05
73867554|NCT01092663|147280108|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
73974386|NCT03213457|147493738|SUPERIORITY||LS Mean of Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.088|<|0.001|TWO_SIDED|95.0|-1.19|-0.845||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.845|-1.190|< 0.001
73974387|NCT03213457|147493739|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-1.156|-0.823||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.823|-1.156|< 0.001
73974388|NCT03213457|147493740|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.073||0.002|TWO_SIDED|95.0|-0.367|-0.08||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.080|-0.367|0.002
73974389|NCT03213457|147493741|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|-0.329|-0.085||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.085|-0.329|< 0.001
73867555|NCT01092663|147280109|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
73867556|NCT01092663|147280110|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
73867557|NCT01092663|147280111|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Treament difference in fasting EGP between the 2 groups were compared.||||>0.05
74031174|NCT03074162|147615887|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|49.6|STANDARD_ERROR_OF_MEAN|38.13|||TWO_SIDED|90.0|43.39|56.71|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/R) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.|||56.71|43.39|
74031175|NCT03074162|147615887|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|83.57|STANDARD_ERROR_OF_MEAN|72.45|||TWO_SIDED|90.0|66.33|105.31|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/A) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation|||105.31|66.33|
73867558|NCT01092663|147280112|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between groups was evaluated||||>0.05
73867559|NCT01092663|147280113|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired ttest||Difference in treatment effect between groups was evaluated||||>0.05
73867560|NCT01092663|147280114|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
73867561|NCT01092663|147280115|SUPERIORITY_OR_OTHER||||||=|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||=0.01
73867562|NCT01092663|147280116|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||differerences in treatment effect between the 2 groups||||>0.05
73867563|NCT01092663|147280117|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
73867564|NCT01092663|147280118|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
73867565|NCT01092663|147280119|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
73867566|NCT01092663|147280120|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
73941029|NCT01212770|147414077|SUPERIORITY||Adjusted Difference|13.0||||0.0134|TWO_SIDED|95.0|3.0|23.1|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||23.1|3.0|0.0134
74031176|NCT01993329|147615891|SUPERIORITY||Geometric means ratio|1.108||||0.616|TWO_SIDED|95.0|0.734|1.673|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.673|0.734|0.616
73867567|NCT01092663|147280121|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
73867568|NCT01092663|147280122|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
73867569|NCT01092663|147280123|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.01
73867570|NCT01092663|147280124|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.01
73867571|NCT01092663|147280125|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
73867572|NCT00781859|147280300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56||||0.003|TWO_SIDED|95.0|1.32|5.24||comparing placebo and ocriplasmin|Fisher Exact|||||5.24|1.32|0.003
73867573|NCT05546229|147280304|OTHER|||||||0.0049|||||||t-test, 2 sided|8 degrees of freedom||patient plasma versus isf value for methadone||||.0049
73867574|NCT05546229|147280305|OTHER|||||||0.0025|||||||t-test, 2 sided|8 degrees of freedom||||||.0025
73867575|NCT01220180|147280324|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73867576|NCT01220180|147280325|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73867577|NCT01220180|147280326|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73867578|NCT01220180|147280327|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73867579|NCT01220180|147280328|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73867580|NCT01220180|147280329|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73867581|NCT01220180|147280330|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73867582|NCT01220180|147280331|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73867583|NCT02713659|147280346|EQUIVALENCE|0.05||||||0.85|||||||t-test, 2 sided|||Auditory standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.85
73867584|NCT02713659|147280346|EQUIVALENCE|0.05||||||0.53|||||||t-test, 2 sided|||Expressive standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.53
73867585|NCT02713659|147280346|EQUIVALENCE|0.05||||||0.49|||||||t-test, 2 sided|||Total standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.49
73867586|NCT02713659|147280347|EQUIVALENCE|0.05||||||0.57|||||||t-test, 2 sided|||Total read scale score between infants at 6 months and 24 months of age in the early literacy arm and the standard literacy arm||||0.57
73867587|NCT02713659|147280348|EQUIVALENCE|0.05||||||0.23|||||||Chi-squared|||Number of up to date child well visits between the early literacy arm and the standard literacy arm at 6 months of age||||0.23
73974390|NCT03213457|147493742|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.056||0.004|TWO_SIDED|95.0|-0.27|-0.05||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.050|-0.270|0.004
73974391|NCT03213457|147493743|SUPERIORITY||LS Mean of Difference|-2.51|STANDARD_ERROR_OF_MEAN|0.9||0.005|TWO_SIDED|95.0|-4.283|-0.746||P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.746|-4.283|0.005
73974392|NCT03213457|147493744|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.098||0.284|TWO_SIDED|95.0|-0.298|0.088||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||0.088|-0.298|0.284
73974393|NCT03213457|147493745|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.092||0.286|TWO_SIDED|95.0|-0.279|0.083||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||0.083|-0.279|0.286
73974394|NCT03213457|147493746|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.079||0.005|TWO_SIDED|95.0|-0.375|-0.066||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.066|-0.375|0.005
73974395|NCT03213457|147493747|SUPERIORITY||LS Mean of Difference|-2.49|STANDARD_ERROR_OF_MEAN|1.158||0.032|TWO_SIDED|95.0|-4.773|-0.216||P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.216|-4.773|0.032
74031177|NCT01993329|147615891|SUPERIORITY||Geometric means ratio|1.016||||0.939|TWO_SIDED|95.0|0.673|1.534|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.534|0.673|0.939
73867588|NCT02713659|147280348|EQUIVALENCE|0.05||||||0.71|||||||Chi-squared|||Number of up to date child vaccinations between the early literacy arm and the standard literacy arm at 6 months of age||||0.71
73867589|NCT04943432|147280356|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||T2 - T1||||0.06
74031178|NCT01993329|147615891|SUPERIORITY||Geometric means ratio|0.917||||0.671|TWO_SIDED|95.0|0.607|1.384|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.384|0.607|0.671
73867590|NCT04943432|147280356|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||T3 - T1||||0.68
73867591|NCT04943432|147280358|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||T2-T1||||.01
73867592|NCT04943432|147280358|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||T3-T1||||.32
73867593|NCT04943432|147280359|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||T2-T1||||.44
73867594|NCT04943432|147280359|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||T3-T1||||.007
73867595|NCT04943432|147280363|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||T2-T1||||.01
73867596|NCT04943432|147280363|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||T3-T1||||.11
73867597|NCT04943432|147280364|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||T2-T1||||.82
73867598|NCT04943432|147280364|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||T3-T1||||.36
73867599|NCT04943432|147280365|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||T2-T1||||.34
73867600|NCT04943432|147280365|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||T3-T1||||.02
73867601|NCT04943432|147280367|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||T2-T1||||.14
73867602|NCT04943432|147280367|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||T3-T1||||.29
73867603|NCT04943432|147280369|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||T2-T1||||<.001
73867604|NCT04943432|147280369|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||T3-T1||||.23
73867605|NCT01727414|147280403|SUPERIORITY|General linear mixed models were used to evaluate the subtype\*dose interaction to determine if the subtypes have unique MPH dose-response curves, with the outcome being Attention Deficit Hyperactivity Disorder total symptom scores (minimum=0, maximum=54, higher=worse)|Slope|0.29|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
73867606|NCT02684188|147280447|SUPERIORITY|||||||0.03||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.|||0.030
73974396|NCT03213457|147493748|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-1.774|-0.508||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.508|-1.774|< 0.001
74008412|NCT00785044|147566519|SUPERIORITY_OR_OTHER|Analysis was performed using the null hypothesis for the AUC stated as: H0: θ ≤A versus H1: θ \>A, where the AUC (θ) value was: 'A' selected based on the diagnostic utility desired from the use of myocardial 123 I-mIBG uptake measured using H/M ratio. A smooth parametric model of the ROC curve was fitted to the data. The AUC for the resulting model was calculated and 95% confidence interval for the AUC was reported. The hypothesis was tested using the Z-statistics at 'A' at level of 0.70.|Mean|0.581|||<|0.001|TWO_SIDED|95.0|0.532|0.63||At 0.05 level of significance.|Z-statistic|||"Analysis was performed on all HF participants from both groups AdreView™ - HF Group (With No Adverse Cardiac Events) and AdreView™ - HF Group (With Adverse Cardiac Events) based on H/M ratio."||0.630|0.532|<0.001
74031179|NCT01993329|147615892|SUPERIORITY||Mean Difference (Final Values)|-0.111||||0.066|TWO_SIDED|95.0|-0.23|0.008|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||0.008|-0.230|0.066
73867607|NCT02684188|147280447|SUPERIORITY|||||||0.025||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 7 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.|||0.025
73867608|NCT02684188|147280447|SUPERIORITY|||||||0.037||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 14 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.|||0.037
73867609|NCT02684188|147280447|SUPERIORITY|||||||0.011||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 21 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.|||0.011
73867610|NCT02684188|147280447|SUPERIORITY|||||||0.05||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 30 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.|||0.050
73867611|NCT02684188|147280447|SUPERIORITY|||||||0.055|||||||Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 60 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.|||0.055
73867612|NCT02684188|147280447|SUPERIORITY|||||||0.137||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 90 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.|||0.137
73867613|NCT02684188|147280448|SUPERIORITY|||||||0.279||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.|||0.279
73974397|NCT03213457|147493749|SUPERIORITY||LS Mean of Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.303|<|0.001|TWO_SIDED|95.0|-1.978|-0.788||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.788|-1.978|< 0.001
73974398|NCT03213457|147493750|SUPERIORITY||LS Mean of Difference|-1.46|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-2.002|-0.915||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.915|-2.002|< 0.001
73867614|NCT02684188|147280448|SUPERIORITY|||||||0.211||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.|||0.211
73867615|NCT02684188|147280448|SUPERIORITY|||||||0.424||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.|||0.424
73867616|NCT02684188|147280448|SUPERIORITY|||||||0.191||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.|||0.191
73867617|NCT02684188|147280448|SUPERIORITY|||||||0.478||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.|||0.478
73867618|NCT02684188|147280448|SUPERIORITY|||||||0.452||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.|||0.452
73867619|NCT02684188|147280448|SUPERIORITY|H0: There is no difference in the proportion of patients with at least one ED visits by day 90 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.||||||0.381||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic||||For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.|||0.381
73867620|NCT02684188|147280449|SUPERIORITY|||||||0.502||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.|||0.502
73867621|NCT02684188|147280449|SUPERIORITY|||||||0.286||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 7 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.|||0.286
73867622|NCT02684188|147280449|SUPERIORITY|||||||0.347||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 14 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.|||0.347
74008413|NCT02953639|147566542|SUPERIORITY||Treatment Difference|-0.36||||0.73|TWO_SIDED|90.0|-2.11|1.38|||Mixed Models Analysis|||Week 12 Day 84||1.38|-2.11|0.730
74008414|NCT02953639|147566542|SUPERIORITY||Treatment Difference|0.28||||0.793|TWO_SIDED|90.0|-1.47|2.02|||Mixed Models Analysis|||Week 24 Day 168||2.02|-1.47|0.793
74008415|NCT02953639|147566543|SUPERIORITY||Treatment Difference|-0.91||||0.556|TWO_SIDED|90.0|-3.46|1.64|||Mixed Models Analysis|||Week 12 Day 84 (Attention/Vigilance)||1.64|-3.46|0.556
74008416|NCT02953639|147566543|SUPERIORITY||Treatment Difference|-0.27||||0.848|TWO_SIDED|90.0|-2.59|2.05|||Mixed Models Analysis|||Week 24 Day 168 (Attention/Vigilance)||2.05|-2.59|0.848
74008417|NCT02953639|147566543|SUPERIORITY||Treatment Difference|0.04||||0.973|TWO_SIDED|90.0|-2.08|2.16|||Mixed Models Analysis|||Week 12 Day 84 (Reasoning and Problem Solving)||2.16|-2.08|0.973
73867623|NCT02684188|147280449|SUPERIORITY|||||||0.25||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 21 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.|||0.250
73867624|NCT02684188|147280449|SUPERIORITY|||||||0.22||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 30 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.220
73867625|NCT02684188|147280449|SUPERIORITY|||||||0.116||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 60 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.|||0.116
73867626|NCT02684188|147280449|SUPERIORITY|||||||0.126||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 90 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.|||0.126
73867627|NCT02684188|147280450|SUPERIORITY|||||||0.597||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.|||0.597
73867628|NCT02684188|147280450|SUPERIORITY|||||||0.504||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.|||0.504
73867629|NCT02684188|147280450|SUPERIORITY|||||||0.558||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.|||0.558
73941030|NCT01212770|147414078|SUPERIORITY||LS Mean Difference|-7.8||||0.0021|TWO_SIDED|95.0|-12.8|-2.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-2.9|-12.8|0.0021
73941031|NCT01212770|147414078|SUPERIORITY||LS Mean Difference|-3.6||||0.1482|TWO_SIDED|95.0|-8.6|1.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||1.3|-8.6|0.1482
73941032|NCT01212770|147414079|SUPERIORITY||LS Mean Difference|-0.2||||0.5349|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.5|-1.0|0.5349
73974399|NCT02382003|147493751|SUPERIORITY||Mean Difference (Net)|10.73||||0.005|TWO_SIDED|||||=Positive\~No-training, 0.030=Positive\~50/50 training, 0.833=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 7.053=Positive\~50/50 training, 0.366=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.005
73974400|NCT02382003|147493751|SUPERIORITY||Mean Difference (Net)|0.449||||0.799|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.799
73974401|NCT02382003|147493751|SUPERIORITY||Mean Difference (Net)|9.085||||0.011|TWO_SIDED|||||=No-train+Neut\~Pos+Anx, 0.026=No-train+Neut\~Pos+Neut, 0.094=No-train+Anx\~Pos+Anx, 0.170=No-train+Anx\~Pos+Neut, No-train(all)\~50/50(all)≥ 0.136|Likelihood Ratio Tests|2=all df|=No-train+Neut\~Pos+Anx, 7.328=No-train+Neut\~Pos+Neut, 4.722=No-train+Anx\~Pos+Anx, 3.547=No-train+Anx\~Pos+Neut, No-train(all)\~50/50(all)≤3.988|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.011
74008418|NCT02953639|147566543|SUPERIORITY||Treatment Difference|0.57||||0.651|TWO_SIDED|90.0|-1.53|2.67|||Mixed Models Analysis|||Week 24 Day 168 (Reasoning and Problem Solving)||2.67|-1.53|0.651
73941033|NCT01212770|147414079|SUPERIORITY||LS Mean Difference|0.1||||0.8231|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.9|-0.7|0.8231
73941034|NCT01212770|147414080|SUPERIORITY||LS Mean Difference|-0.8||||0.072|TWO_SIDED|95.0|-1.7|0.1|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.1|-1.7|0.0720
73941035|NCT01212770|147414080|SUPERIORITY||LS Mean Difference|-0.4||||0.3641|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.5|-1.3|0.3641
73974402|NCT02382003|147493752|SUPERIORITY||Mean Difference (Net)|11.551||||0.003|TWO_SIDED|||||"=Positive\~No-training, 0.130=Positive\~50/50 training, 0.269=50/50\~No-training~Alpha = .05"|Likelihood Ratio Tests|2=Positive\~No-training, 2=Positive\~50/50 training, 2=50/50\~No-training|=Positive\~No-training, 4.075=Positive\~50/50 training, 2.630=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.003
73974403|NCT02382003|147493752|SUPERIORITY||Mean Difference (Net)|3.933||||0.14|TWO_SIDED|||||Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime||Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.140
73974404|NCT02382003|147493752|SUPERIORITY||Mean Difference (Net)|6.018||||0.049|TWO_SIDED|||||=No-train+Neut\~Pos+Anx,0.049=No-train+Neut\~Pos+Neut,Positive(all)\~No-train+Anx≥0.198,50/50(all)\~No-train+Anx≥0.104,0.014=No-train+Neut\~50/50+Neut,0.627=No-train+Neut\~50/50+Anx,0.021=Pos+Anx\~50/50+Anx,0.764=Pos+Anx\~50/50+Neut,Pos+Neut\~50/50(all)≥0.067|Likelihood Ratio Tests|2=all df|=No-train+Neut\~Pos+Anx,6.041=No-train+Neut\~Pos+Neut,Positive(all)\~No-train+Anx≤3.240,50/50(all)\~No-train+Anx≤4.534,8.525=No-train+Neut\~50/50+Neut,0.933=No-train+Neut\~50/50+Anx,7.686=Pos+Anx\~50/50+Anx,0.537=Pos+Anx\~50/50+Neut,Pos+Neut\~50/50(all)≤5.395|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.049
73941036|NCT01212770|147414081|SUPERIORITY||LS Mean Difference|-4.94||||0.0001|TWO_SIDED|95.0|-7.34|-2.53|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-2.53|-7.34|0.0001
73941037|NCT01212770|147414081|SUPERIORITY||LS Mean Difference|-1.85||||0.1325|TWO_SIDED|95.0|-4.27|0.56|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.56|-4.27|0.1325
73974405|NCT02382003|147493753|SUPERIORITY||Mean Difference (Net)|17.42|||<|0.001|TWO_SIDED|||||=Positive\~No-training, Positive\~50/50 training\<0.001, 0.124=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 31.921=Positive\~50/50 training, 4.175=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||<0.001
73974406|NCT02382003|147493753|SUPERIORITY||Mean Difference (Net)|0.634||||0.728|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.728
73974407|NCT02382003|147493753|SUPERIORITY||Mean Difference (Net)|15.034|||<|0.001|TWO_SIDED|||||=Pos+Anx\~No-train+Neut, 0.026=Pos+Anx\~No-train+Anx, 0.002=Pos+Neut\~No-train+Neut, 0.091=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train(all)≥ 0.081, Positive(all)\~50/50(all)\< 0.001|Likelihood Ratio Tests|2=all df|=Pos+Anx\~No-train+Neut, 7.306=Pos+Anx\~No-train+Anx, 12.672=Pos+Neut\~No-train+Neut, 4.802=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train(all)≤5.037, Positive(all)\~50/50(all)≥16.239|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||<0.001
74008419|NCT02953639|147566543|SUPERIORITY||Treatment Difference|-1.44||||0.35|TWO_SIDED|90.0|-3.89|1.08|||Mixed Models Analysis|||Week 12 Day 84 (Social Cognition)||1.08|-3.89|0.350
74008420|NCT02953639|147566543|SUPERIORITY||Treatment Difference|2.18||||0.121|TWO_SIDED|90.0|-0.14|4.5|||Mixed Models Analysis|||Week 24 Day 168 (Social Cognition)||4.50|-0.14|0.121
74008421|NCT02953639|147566543|SUPERIORITY||Treatment Difference|-0.13||||0.911|TWO_SIDED|90.0|-2.1|1.83|||Mixed Models Analysis|||Week 12 Day 84 (Speed of Processing)||1.83|-2.10|0.911
73941038|NCT01212770|147414082|SUPERIORITY||LS Mean Difference|-0.47||||0.0001|TWO_SIDED|95.0|-0.7|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.24|-0.70|0.0001
73941039|NCT01212770|147414082|SUPERIORITY||LS Mean Difference|-0.27||||0.0237|TWO_SIDED|95.0|-0.5|-0.04|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.04|-0.50|0.0237
73867630|NCT02684188|147280450|SUPERIORITY|||||||0.472||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.|||0.472
74008422|NCT02953639|147566543|SUPERIORITY||Treatment Difference|0.02||||0.987|TWO_SIDED|90.0|-1.99|2.03|||Mixed Models Analysis|||Week 24 Day 168 (Speed of Processing)||2.03|-1.99|0.987
74008423|NCT02953639|147566543|SUPERIORITY||Treatment Difference|-0.34||||0.803|TWO_SIDED|90.0|-2.62|1.93|||Mixed Models Analysis|||Week 12 Day 84 (Verbal Learning)||1.93|-2.62|0.803
74008424|NCT02953639|147566543|SUPERIORITY||Treatment Difference|-0.94||||0.502|TWO_SIDED|90.0|-3.26|1.38|||Mixed Models Analysis|||Week 24 Day 168 (Verbal Learning)||1.38|-3.26|0.502
74008425|NCT02953639|147566543|SUPERIORITY||Treatment Difference|-0.11||||0.945|TWO_SIDED|90.0|-2.74|2.52|||Mixed Models Analysis|||Week 12 Day 84 (Visual Learning)||2.52|-2.74|0.945
74008426|NCT02953639|147566543|SUPERIORITY||Treatment Difference|1.11||||0.488|TWO_SIDED|90.0|-1.54|3.76|||Mixed Models Analysis|||Week 24 Day 168 (Visual Learning)||3.76|-1.54|0.488
74008427|NCT02953639|147566543|SUPERIORITY||Treatment Difference|-1.37||||0.262|TWO_SIDED|90.0|-3.38|0.64|||Mixed Models Analysis|||Week 12 Day 84 (Working Memory)||0.64|-3.38|0.262
74008428|NCT02953639|147566543|SUPERIORITY||Treatment Difference|-0.89||||0.489|TWO_SIDED|90.0|-3.01|1.23|||Mixed Models Analysis|||Week 24 Day 168 (Working Memory)||1.23|-3.01|0.489
73941040|NCT01212770|147414083|SUPERIORITY||LS Mean Difference|2.54||||0.0049|TWO_SIDED|95.0|0.77|4.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||4.30|0.77|0.0049
73941041|NCT01212770|147414083|SUPERIORITY||LS Mean Difference|0.68||||0.4505|TWO_SIDED|95.0|-1.09|2.44|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||2.44|-1.09|0.4505
73941042|NCT01212770|147414084|SUPERIORITY||LS Mean Difference|2.34||||0.0043|TWO_SIDED|95.0|0.74|3.94|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||3.94|0.74|0.0043
73941043|NCT01212770|147414084|SUPERIORITY||LS Mean Difference|1.67||||0.0404|TWO_SIDED|95.0|0.07|3.27|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||3.27|0.07|0.0404
73941044|NCT01212770|147414085|SUPERIORITY||Adjusted Difference|21.2|||<|0.0001|TWO_SIDED|95.0|11.5|30.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and and involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||30.9|11.5|< 0.0001
73941045|NCT01212770|147414085|SUPERIORITY||Adjusted Difference|8.7||||0.0661|TWO_SIDED|95.0|-0.5|18.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||18.0|-0.5|0.0661
73941046|NCT01212770|147414086|SUPERIORITY||Adjusted Difference|14.8||||0.0099|TWO_SIDED|95.0|3.8|25.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.7|3.8|0.0099
73941047|NCT01212770|147414086|SUPERIORITY||Adjusted Difference|10.8||||0.0515|TWO_SIDED|95.0|0.1|21.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.4|0.1|0.0515
73941048|NCT01212770|147414087|SUPERIORITY||LS mean Difference|-6.6||||0.008|TWO_SIDED|95.0|-11.4|-1.7|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-1.7|-11.4|0.0080
73941049|NCT01212770|147414087|SUPERIORITY||LS Mean Difference|-3.8||||0.1218|TWO_SIDED|95.0|-8.6|1.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||1.0|-8.6|0.1218
73941050|NCT01212770|147414088|SUPERIORITY||LS Mean Difference|-0.4||||0.2761|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.4|-1.3|0.2761
73941051|NCT01212770|147414088|SUPERIORITY||LS Mean Difference|-0.3||||0.5012|TWO_SIDED|95.0|-1.1|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.6|-1.1|0.5012
73941052|NCT01212770|147414089|SUPERIORITY||LS Mean Difference|-1.0||||0.0399|TWO_SIDED|95.0|-1.9|0.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.0|-1.9|0.0399
73941053|NCT01212770|147414089|SUPERIORITY||LS Mean Difference|-0.4||||0.4413|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.6|-1.3|0.4413
73941054|NCT01212770|147414090|SUPERIORITY||LS Mean Difference|-5.27|||<|0.0001|TWO_SIDED|95.0|-7.73|-2.82|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-2.82|-7.73|< 0.0001
73867631|NCT02684188|147280450|SUPERIORITY|||||||0.462||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.462
73867632|NCT02684188|147280450|SUPERIORITY|||||||0.394||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.|||0.394
73867633|NCT02684188|147280450|SUPERIORITY|||||||0.368||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 90; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.|||0.368
73941055|NCT01212770|147414090|SUPERIORITY||LS Mean Difference|-2.65||||0.0349|TWO_SIDED|95.0|-5.11|-0.19|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.19|-5.11|0.0349
73941056|NCT01212770|147414091|SUPERIORITY||LS Mean Difference|-0.48||||0.0001|TWO_SIDED|95.0|-0.72|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.24|-0.72|0.0001
73941057|NCT01212770|147414091|SUPERIORITY||LS Mean Difference|-0.3||||0.0147|TWO_SIDED|95.0|-0.54|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.06|-0.54|0.0147
73941058|NCT01212770|147414092|SUPERIORITY||LS Mean Difference|2.44||||0.0078|TWO_SIDED|95.0|0.64|4.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||4.24|0.64|0.0078
73941059|NCT01212770|147414092|SUPERIORITY||LS Mean Difference|1.19||||0.1936|TWO_SIDED|95.0|-0.61|2.98|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||2.98|-0.61|0.1936
73974408|NCT02382003|147493754|SUPERIORITY||Mean Difference (Net)|13.924|||<|0.001|TWO_SIDED|||||=Positive\~No-training, Positive\~50/50 training\< 0.001, 0.100=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 15.288=Positive\~50/50 training, 4.605=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||< 0.001
73974409|NCT02382003|147493754|SUPERIORITY||Mean Difference (Net)|4.011||||0.135|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.135
73941060|NCT01212770|147414093|SUPERIORITY||Adjusted Difference|2.1||||0.7585|TWO_SIDED|95.0|-10.9|15.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||15.0|-10.9|0.7585
73941061|NCT01212770|147414093|SUPERIORITY||Adjusted Difference|-3.9||||0.5808|TWO_SIDED|95.0|-17.4|9.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||9.7|-17.4|0.5808
73941062|NCT01212770|147414094|SUPERIORITY||Adjusted Difference|12.0||||0.1303|TWO_SIDED|95.0|-3.1|27.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD useinvolvement of \>= 3% BSA with psoriasis at baseline..|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||27.0|-3.1|0.1303
73941063|NCT01212770|147414094|SUPERIORITY||Adjusted Difference|7.5||||0.361|TWO_SIDED|95.0|-8.3|23.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||23.2|-8.3|0.3610
73941064|NCT01212770|147414095|SUPERIORITY||Adjusted Difference|22.5|||<|0.0001|TWO_SIDED|95.0|12.4|32.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||32.6|12.4|< 0.0001
74008429|NCT02953639|147566544|SUPERIORITY||Treatment Difference|-1.63||||0.211|TWO_SIDED|90.0|-3.78|0.52|||Mixed Models Analysis|||Week 12 Day 84 (VPA I total raw score)||0.52|-3.78|0.211
74008430|NCT02953639|147566544|SUPERIORITY||Treatment Difference|0.35||||0.787|TWO_SIDED|90.0|-1.81|2.52|||Mixed Models Analysis|||Week 24 Day 168 (VPA I total raw score)||2.52|-1.81|0.787
73867634|NCT02684188|147280451|SUPERIORITY|||||||0.946||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||The following hypotheses were tested: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.|||0.946
73941065|NCT01212770|147414095|SUPERIORITY||Adjusted Difference|11.0||||0.0309|TWO_SIDED|95.0|1.2|20.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||20.9|1.2|0.0309
73867635|NCT02684188|147280451|SUPERIORITY|||||||0.613|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.|||0.613
73941066|NCT01212770|147414096|SUPERIORITY||Adjusted Difference|3.8||||0.5731|TWO_SIDED|95.0|-9.1|16.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||16.7|-9.1|0.5731
73941067|NCT01212770|147414096|SUPERIORITY||Adjusted Difference|1.0||||0.8876|TWO_SIDED|95.0|-12.6|14.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||14.6|-12.6|0.8876
74031180|NCT01993329|147615892|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.843|TWO_SIDED|95.0|-0.131|0.107|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect|||0.107|-0.131|0.843
73867636|NCT02684188|147280451|SUPERIORITY|||||||0.541||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.|||0.541
73867637|NCT02684188|147280451|SUPERIORITY|||||||0.765||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|For day 21, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.765
73867638|NCT02684188|147280451|SUPERIORITY|||||||0.919||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.|||0.919
73867639|NCT02684188|147280451|SUPERIORITY|||||||0.999||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.|||0.999
73867640|NCT02684188|147280451|SUPERIORITY|||||||0.995|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.|||0.995
73941068|NCT01212770|147414097|SUPERIORITY||Adjusted Difference|12.2||||0.1172|TWO_SIDED|95.0|-2.5|26.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||26.9|-2.5|0.1172
73974410|NCT02382003|147493754|SUPERIORITY||Mean Difference (Net)|9.402||||0.009|TWO_SIDED|||||=Pos+Anx\~No-train+Neut, Pos+Anx\~No-train+Anx\<0.048, Pos+Neut\~No-train+Neut\<0.001, 0.055=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train+Anx≥0.139, 0.034=No-train+Neut\~50/50+Neut, 0.340=No-train+Neut\~50/50+Anx, Pos(all)\~50/50(all)≥ 0.087|Likelihood Ratio Tests|2=all df|=Pos+Anx\~No-train+Neut, 6.076=Pos+Anx\~No-train+Anx, 14.525=Pos+Neut\~No-train+Neut, 5.811=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train+Anx≤3.950, 6.770=No-train+Neut\~50/50+Neut, 2.158=No-train+Neut\~50/50+Anx, Pos(all)\~50/50(all)≤4.876|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.009
73974411|NCT05934292|147493759|OTHER||Geometric Mean Ratio|1.5|||||TWO_SIDED|90.0|0.98|2.31|||||Geometric mean ratio (GMR) and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||2.31|0.98|
74031181|NCT01993329|147615892|SUPERIORITY||Mean Difference (Final Values)|-0.099||||0.098|TWO_SIDED|95.0|-0.218|0.02|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect|||0.020|-0.218|0.098
73867641|NCT02684188|147280452|EQUIVALENCE|A repeated measures ANOVA model was used to model the SF12 Physical Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, and the number of people in a household. All hypotheses were 2-sided and p-values \< 0.05 were considered statistically significant.||||||0.371||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.371, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF12 Physical Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF12 Physical Health scores differ between the standard and enhanced discharge groups.||||0.371
73867642|NCT02684188|147280453|EQUIVALENCE|A repeated measures ANOVA model was used to model the SF-12 Mental Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and county. All hypotheses were 2-sided and p-values \< 0.05 were considered statistically significant.||||||0.232||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.232, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF-12 Mental Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF-12 Mental Health scores differ between the standard and enhanced discharge groups.||||0.232
73867643|NCT02684188|147280454|SUPERIORITY|||||||0.806|||||||ANCOVA|||The following hypotheses were tested: H0: There is no difference in the mean CTM3 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean CTM3 rating than patients in the standard discharge group.|An analysis of covariance was used to model the CTM3 discharge planning score as a function of treatment group. An ANOVA F-test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of patient age and income. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values \< 0.05 were considered statistically significant. The covariates Sex, County, Number in Household, LACE+ score, and PAM10 score did not differ in their mean CTM3 scores so were not retained in the model.|||0.806
73867644|NCT02684188|147280455|SUPERIORITY|||||||0.742|||||||ANOVA|||The following hypotheses were tested: H0: There is no difference in the mean RTM14 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean RTM14 rating than patients in the standard discharge group.|A repeated measures ANOVA model (over the 6 time measurement periods) was used to model the RTM14 score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and whether or not a patient had visited a hospital or ED prior to that day. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values \< 0.05 were considered statistically significant. The covariates Sex, Number in household, LACE+ score, and PAM10 score were not significant in explaining SF-12 scores so were not retained in the model.|||0.742
73867645|NCT02684188|147280456|SUPERIORITY|||||||0.717||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.|||0.717
73867646|NCT02684188|147280456|SUPERIORITY|||||||0.479||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.|||0.479
73941069|NCT01212770|147414097|SUPERIORITY||Adjusted Difference|7.2||||0.3695|TWO_SIDED|95.0|-8.2|22.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||22.6|-8.2|0.3695
73941070|NCT01212770|147414098|SUPERIORITY||Adjusted Difference|22.5|||<|0.0001|TWO_SIDED|95.0|13.0|32.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||32.1|13.0|< 0.0001
73941071|NCT01212770|147414098|SUPERIORITY||Adjusted Difference|11.7||||0.0123|TWO_SIDED|95.0|2.7|20.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||20.7|2.7|0.0123
73941072|NCT01212770|147414099|SUPERIORITY||Adjusted Difference|6.8||||0.052|TWO_SIDED|95.0|0.0|13.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||13.5|0.0|0.0520
73941073|NCT01212770|147414099|SUPERIORITY||Adjusted Difference|4.2||||0.2052|TWO_SIDED|95.0|-2.2|10.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||10.6|-2.2|0.2052
73941074|NCT01212770|147414100|SUPERIORITY||Adjusted Difference|1.2||||0.5154|TWO_SIDED|95.0|-2.4|4.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||4.8|-2.4|0.5154
73941075|NCT01212770|147414100|SUPERIORITY||Adjusted Difference|2.3||||0.2527|TWO_SIDED|95.0|-1.5|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.2|-1.5|0.2527
73941076|NCT01212770|147414101|SUPERIORITY||Adjusted Difference|8.3||||0.018|TWO_SIDED|95.0|1.6|15.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||15.1|1.6|0.0180
73941077|NCT01212770|147414101|SUPERIORITY||Adjusted Difference|5.8||||0.0807|TWO_SIDED|95.0|-0.6|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||12.3|-0.6|0.0807
73941078|NCT01212770|147414102|SUPERIORITY||Adjusted Difference|1.8||||0.423|TWO_SIDED|95.0|-2.6|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.2|-2.6|0.4230
73941079|NCT01212770|147414102|SUPERIORITY||Adjusted Difference|0.6||||0.787|TWO_SIDED|95.0|-3.5|4.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||4.6|-3.5|0.7870
73974412|NCT05934292|147493759|OTHER||Geometric Mean Ratio|1.14|||||TWO_SIDED|90.0|0.74|1.74|||Geometric Mean Ratio||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.74|0.74|
73974413|NCT05934292|147493759|OTHER||Geometric Mean Ratio|1.75|||||TWO_SIDED|90.0|1.1|2.78|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||2.78|1.10|
74039428|NCT04847141|147632420|SUPERIORITY||Difference in Percentage|0.02||||0.9853|TWO_SIDED|95.0|-3.05|3.12||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required ICU admission between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||3.12|-3.05|0.9853
73941080|NCT01212770|147414103|SUPERIORITY||Adjusted Difference|-4.1||||0.4707|TWO_SIDED|95.0|-14.8|6.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.5|-14.8|0.4707
73941081|NCT01212770|147414103|SUPERIORITY||Adjusted Difference|-5.4||||0.3547|TWO_SIDED|95.0|-16.6|5.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||5.7|-16.6|0.3547
73941082|NCT01212770|147414104|SUPERIORITY||Adjusted Difference|6.6||||0.4175|TWO_SIDED|95.0|-8.6|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.8|-8.6|0.4175
73974414|NCT05934292|147493759|OTHER||Geometric Mean Ratio|1.17|||||TWO_SIDED|90.0|0.77|1.77|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.77|0.77|
73974415|NCT05934292|147493760|OTHER||Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.05|2.46|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||2.46|1.05|
73974416|NCT05934292|147493760|OTHER||Geometric Mean ratio|0.79|||||TWO_SIDED|90.0|0.37|1.72|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.72|0.37|
73974417|NCT05934292|147493760|OTHER||Geometric Mean Ratio|1.42|||||TWO_SIDED|90.0|0.8|2.54|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||2.54|0.80|
73974418|NCT05934292|147493760|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.78|1.78|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.78|0.78|
73974419|NCT05934292|147493761|OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.71|1.37|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls.|||1.37|0.71|
73974420|NCT05934292|147493761|OTHER||Geometric Mean Ratio|0.6|||||TWO_SIDED|90.0|0.34|1.04|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls.|||1.04|0.34|
73974421|NCT05934292|147493761|OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.64|1.27|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls.|||1.27|0.64|
73974422|NCT05934292|147493761|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.78|1.78|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls.|||1.78|0.78|
73974423|NCT05934292|147493764|OTHER||Geometric Mean Ratio|0.67|||||TWO_SIDED|90.0|0.43|1.02|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||1.02|0.43|
73974424|NCT05934292|147493764|OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.58|1.35|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.35|0.58|
73974425|NCT05934292|147493764|OTHER||Geomtric Mean ratio|0.57|||||TWO_SIDED|90.0|0.36|0.91|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||0.91|0.36|
73974426|NCT05934292|147493764|OTHER||Geomtric Mean Ratio|0.86|||||TWO_SIDED|90.0|0.57|1.29|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.29|0.57|
73974427|NCT05934292|147493765|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.83|1.67|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||1.67|0.83|
73974428|NCT05934292|147493765|OTHER||Geometric Mean ratio|1.08|||||TWO_SIDED|90.0|0.78|1.5|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.50|0.78|
74089110|NCT03575871|147731434|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-2.7|0.3207
73974429|NCT05934292|147493765|OTHER||Geometric Mean Ratio|0.66|||||TWO_SIDED|90.0|0.5|0.89|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||0.89|0.50|
73974430|NCT05934292|147493765|OTHER||Geometric Mean Ratio|1.4|||||TWO_SIDED|90.0|1.0|1.97|||||GMR and 90% CI for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.97|1.00|
73974431|NCT05934292|147493770|OTHER||Geometric Mean Ratio|0.32|||||TWO_SIDED|90.0|0.14|0.74|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.74|0.14|
73974432|NCT05934292|147493770|OTHER||Geometric Mean Ratio|0.09|||||TWO_SIDED|90.0|0.04|0.22|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.22|0.04|
73974433|NCT05934292|147493771|OTHER||Geometric Mean Ratio|0.32|||||TWO_SIDED|90.0|0.14|0.74|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.74|0.14|
73974434|NCT05934292|147493771|OTHER||Geometric Mean Ratio|0.09|||||TWO_SIDED|90.0|0.04|0.22|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.22|0.04|
73974435|NCT05934292|147493772|OTHER||Geometric Mean Ratio|0.29|||||TWO_SIDED|90.0|0.16|0.55|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.55|0.16|
73974436|NCT05934292|147493772|OTHER||Geometric Mean Ratio|0.14|||||TWO_SIDED|90.0|0.06|0.36|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.36|0.06|
73974437|NCT04479787|147493776|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
73974438|NCT04479787|147493777|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||< 0.0001
73974439|NCT04479787|147493778|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
73974440|NCT04479787|147493779|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
73974441|NCT04479787|147493780|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
73974442|NCT04479787|147493781|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
73974443|NCT04479787|147493782|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
73974444|NCT04479787|147493783|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
74008431|NCT02953639|147566544|SUPERIORITY||Treatment Difference|0.28||||0.477|TWO_SIDED|90.0|-0.37|0.94|||Mixed Models Analysis|||Week 12 Day 84 (VPA II total raw score)||0.94|-0.37|0.477
73867647|NCT02684188|147280456|SUPERIORITY|||||||0.329|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.|||0.329
73941083|NCT01212770|147414104|SUPERIORITY||Adjusted Difference|6.4||||0.437|TWO_SIDED|95.0|-9.1|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.8|-9.1|0.4370
73941084|NCT01212770|147414105|SUPERIORITY||Adjusted Difference|-0.4||||0.9463|TWO_SIDED|195.0|-12.1|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||11.3|-12.1|0.9463
73941085|NCT01212770|147414105|SUPERIORITY||Adjusted Difference|-7.7||||0.2032|TWO_SIDED|95.0|-19.3|3.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||3.8|-19.3|0.2032
73941086|NCT01212770|147414106|SUPERIORITY||Adjusted Difference|9.8||||0.2321|TWO_SIDED|95.0|-5.8|25.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.4|-5.8|0.2321
73941087|NCT01212770|147414106|SUPERIORITY||Adjusted Difference|9.6||||0.252|TWO_SIDED|95.0|-6.2|25.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.3|-6.2|0.2520
73974445|NCT05714059|147493784|NON_INFERIORITY|The overall mean change in HbA1c, from baseline to end of 3-month study period was estimated and compared by a non-inferiority test to the threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.3|-0.6|<0.001
73974446|NCT05714059|147493784|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period was estimated and compared by a non-inferiority test to the threshold of -0.50% with a margin of 0.4%. A significance level of 0.025 (one-sided) was used|Mean difference from baseline to exit|-0.7|||<|0.001|TWO_SIDED|95.0|-0.8|-0.6|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.6|-0.8|<0.001
73974447|NCT05714059|147493785|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 65.3% with a margin of 7.5%.|Mean value (Final Values)|71.4|||<|0.001|TWO_SIDED|95.0|69.5|73.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||73.3|69.5|<0.001
73974448|NCT05714059|147493785|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 73.7% with a margin of 7.5%.|Mean value (Final Values)|80.2|||<|0.001|TWO_SIDED|95.0|78.7|81.8|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||81.8|78.7|<0.001
73974449|NCT05714059|147493786|NON_INFERIORITY|The mean % time in hypoglycemia (\< 54 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 0.71% with a margin of 2%.|Mean value (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from last 6-7 weeks of 3 month study period was estimated for this endpoint.|||0.4|0.3|<0.001
73941088|NCT01112579|147414139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.3|TWO_SIDED|95.0|-2.0|14.9|||ANCOVA|||||14.9|-2.0|0.3
73941089|NCT01112579|147414140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.1||||0.79|TWO_SIDED|95.0|-845.8|633.6|||ANCOVA|||||633.6|-845.8|0.79
73941090|NCT01112579|147414141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.93|TWO_SIDED|95.0|-1.6|3.2|||ANCOVA|||||3.2|-1.6|0.93
73941091|NCT00818753|147414142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.08|12.76||p-values were not presented as the study was exploratory and not powered to to detect a difference in the treatments|Cochran-Mantel-Haenszel|||Dabigatran 110mg BID vs Heparin||12.76|0.08|
73941092|NCT00818753|147414142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||||95.0|0.13|16.82||p-values were not presented as the study was exploratory and not powered to to detect a difference in the treatments|Cochran-Mantel-Haenszel|||Dabigatran 150mg BID vs Heparin||16.82|0.13|
73974450|NCT05714059|147493786|NON_INFERIORITY|The mean % time in hypoglycemia (\< 54 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 0.86% with a margin of 2%.|Mean value (Final Values)|0.2|||<|0.001|TWO_SIDED|95.0|0.1|0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) were summarized from last 6-7 weeks of 3 month study period for this endpoint|||0.3|0.1|<0.001
73941093|NCT04508699|147414171|OTHER|||||||0.36|||||||t-test, 1 sided|||||||0.36
73941094|NCT04508699|147414172|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
73941095|NCT04508699|147414173|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
73941096|NCT04508699|147414174|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
73867648|NCT02684188|147280456|SUPERIORITY|||||||0.78|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|This Hypothesis was tested with no adjustments for covariates since none were significant.|||0.780
73867649|NCT02684188|147280456|SUPERIORITY|||||||0.779||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.|||0.779
73941097|NCT04508699|147414175|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
73941098|NCT04508699|147414176|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
73867650|NCT02684188|147280456|SUPERIORITY|||||||0.848||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.|||0.848
73867651|NCT02684188|147280456|SUPERIORITY|||||||0.857||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.|||0.857
73867652|NCT00488826|147280457|SUPERIORITY_OR_OTHER||Geometric mean ratio|1097.0||||||90.0|793.6|1461.0||P-Values were not calculated.|||This analysis is for Serotype 4.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||1461|793.6|
73867653|NCT00488826|147280457|SUPERIORITY_OR_OTHER||Geometric mean ratio|54.6||||||90.0|35.36|85.49||P-Values were not calculated.|||This analysis is for Serotype 6B.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||85.49|35.36|
73867654|NCT00488826|147280457|SUPERIORITY_OR_OTHER||Geometric mean ratio|99.48||||||90.0|79.81|142.0||P-Values were not calculated.|||This analysis is for Serotype 9V|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||142.0|79.81|
73867655|NCT00488826|147280457|SUPERIORITY_OR_OTHER||Geometric mean ratio|134.3||||||90.0|80.83|197.1||P-Values were not calculated.|||This analysis is for Serotype 14.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||197.1|80.83|
73867656|NCT00488826|147280457|SUPERIORITY_OR_OTHER||Geometric mean ratio|200.3||||||90.0|151.9|302.4||P-Values were not calculated.|||This analysis is for Serotype 18C.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||302.4|151.9|
73867657|NCT00488826|147280457|SUPERIORITY_OR_OTHER||Geometric mean ratio|181.3||||||90.0|119.8|253.1||P-Values were not calculated.|||This analysis is for Serotype 19F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||253.1|119.8|
73867658|NCT00488826|147280457|SUPERIORITY_OR_OTHER||Geometric mean ratio|90.02||||||90.0|57.93|150.5||P-Values were not calculated.|||This analysis is for Serotype 23F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||150.5|57.93|
73941099|NCT04508699|147414177|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
74008432|NCT02953639|147566544|SUPERIORITY||Treatment Difference|0.91||||0.028|TWO_SIDED|90.0|0.23|1.58|||Mixed Models Analysis|||Week 24 Day 168 (VPA II total raw score)||1.58|0.23|0.028
73867659|NCT00488826|147280458|SUPERIORITY_OR_OTHER||Geometric mean ratio|665.1||||||90.0|473.3|851.2||P-Values were not calculated.|||This analysis is for Serotype 4.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||851.2|473.3|
73867660|NCT00488826|147280458|SUPERIORITY_OR_OTHER||Geometric mean ratio|22.2||||||90.0|13.99|31.77||P-Values were not calculated.|||This analysis is for Serotype 6B.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||31.77|13.99|
73867661|NCT00488826|147280458|SUPERIORITY_OR_OTHER||Geometric mean ratio|73.7||||||90.0|56.41|103.6||P-Values were not calculated.|||This analysis is for Serotype 9V.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||103.6|56.41|
73867662|NCT00488826|147280458|SUPERIORITY_OR_OTHER||Geometric mean ratio|99.48||||||90.0|61.09|147.5||P-Values were not calculated.|||This analysis is for Serotype 14.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||147.5|61.09|
73941100|NCT04508699|147414178|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
73941101|NCT03355326|147414179|SUPERIORITY|||||||0.971|||||||Wilcoxon (Mann-Whitney)|||||||0.971
73941102|NCT03355326|147414180|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.900
73941103|NCT03355326|147414181|SUPERIORITY|||||||0.648|||||||Wilcoxon (Mann-Whitney)|||||||0.648
73941104|NCT03355326|147414182|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||||||0.967
73941105|NCT03355326|147414183|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
73867663|NCT00488826|147280458|SUPERIORITY_OR_OTHER||Geometric mean ratio|164.0||||||90.0|114.9|232.9||P-Values were not calculated.|||This analysis is for Serotype 18C.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||232.9|114.9|
73867664|NCT00488826|147280458|SUPERIORITY_OR_OTHER||Geometric mean ratio|81.45||||||90.0|57.98|119.1||P-Values were not calculated.|||This analysis is for Serotype 19F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||119.1|57.98|
73867665|NCT00488826|147280458|SUPERIORITY_OR_OTHER||Geometric mean ratio|44.7||||||90.0|29.48|68.71||P-Values were not calculated.|||This analysis is for Serotype 23F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||68.71|29.48|
73974451|NCT05714059|147493787|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared to a threshold of 65.3% by a simple superiority test|Mean value (Final Values)|71.4|||<|0.001|TWO_SIDED|95.0|69.5|73.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||73.3|69.5|<0.001
73974452|NCT05714059|147493787|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared to a threshold of 73.7% by a simple superiority test|Mean value (Final Values)|80.2|||<|0.001|TWO_SIDED|95.0|78.7|81.8|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||81.8|78.7|<0.001
73867666|NCT01854281|147280496|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.||||0.02
73867667|NCT01854281|147280496|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.||||<0.01
73867668|NCT01431963|147280520|SUPERIORITY_OR_OTHER||percentage of participants|43.1|||||TWO_SIDED|95.0|30.85|55.96|||||The estimated value reflects the percentage of participants who were seizure free for all seizures.|||55.96|30.85|
73867669|NCT01431963|147280520|SUPERIORITY_OR_OTHER||percentage of participants|40.0|||||TWO_SIDED|95.0|27.02|54.09|||||The estimated value reflects the percentage of participants who were seizure free for A+B+C seizures.|||54.09|27.02|
73867670|NCT01431963|147280520|SUPERIORITY_OR_OTHER||percentage of participants|40.5|||||TWO_SIDED|95.0|25.63|56.72|||||The estimated value reflects the percentage of participants who were seizure free for A+B seizures.|||56.72|25.63|
73941106|NCT03355326|147414184|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
73941107|NCT03355326|147414185|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
73941108|NCT00608582|147414188|SUPERIORITY_OR_OTHER||||||<|0.028||||||p\<0.05 considered significant|ANOVA|Post-hoc paired t-tests were performed.||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 Mo. Post rTMS treatment) and Group (Real vs. Sham).||||<0.028
73941109|NCT00608582|147414188|SUPERIORITY_OR_OTHER||||||<|0.05||||||p\<.05 considered significant; Pairwise comparisons not adjusted for multiple comparisons|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 months after last rTMS treatment.||||<0.05
74008433|NCT02953639|147566544|SUPERIORITY||Treatment Difference|-0.3||||0.683|TWO_SIDED|90.0|-1.51|0.91|||Mixed Models Analysis|||Week 12 Day 84 (VPA II recognition total raw score)||0.91|-1.51|0.683
74008434|NCT02953639|147566544|SUPERIORITY||Treatment Difference|0.04||||0.954|TWO_SIDED|90.0|-1.13|1.22|||Mixed Models Analysis|||Week 24 Day 168 (VPA II recognition total raw score)||1.22|-1.13|0.954
73867671|NCT01431963|147280520|SUPERIORITY_OR_OTHER||percentage of participants|69.7|||||TWO_SIDED|95.0|51.29|84.41|||||The estimated value reflects the percentage of participants who were seizure free for C seizures.|||84.41|51.29|
73867672|NCT01431963|147280520|SUPERIORITY_OR_OTHER||percentage of participants|80.0|||||TWO_SIDED|95.0|44.39|97.48|||||The estimated value reflects the percentage of participants who were seizure free for D5 seizures.|||97.48|44.39|
73867673|NCT02921087|147280527|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the primary outcome (change in overall VAS at day 7) mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.07
73867674|NCT02921087|147280529|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for accommodative response mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.01
73867675|NCT02921087|147280530|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the change in CISS, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.77
73867676|NCT02921087|147280531|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the CLDEQ-8, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.69
73941110|NCT00608582|147414188|SUPERIORITY_OR_OTHER||||||<|0.237||||||p\<0.05 considered significant. Pairwise comparisons were not corrected for multiple comparisons.|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 Mo. after last Sham rTMS treatment.||||<0.237
73941111|NCT00608582|147414189|SUPERIORITY_OR_OTHER|||||||0.414||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||0.414
73941112|NCT00608582|147414189|SUPERIORITY_OR_OTHER||||||<|0.822||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||<0.822
73974453|NCT04899674|147493788|OTHER||Ratio of gMeans [%]|94.6|||||TWO_SIDED|90.0|86.3|103.8|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone). Intra-individual geometric coefficient of variation (gCV \[%\])=13.9."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA) model. The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||103.8|86.3|
73974454|NCT04899674|147493789|OTHER||Ratio of gMeans[%]|90.7|||||TWO_SIDED|90.0|74.3|110.7|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone).~Intra-individual geometric coefficient of variation (gCV \[%\])=31.5."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA) model. The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||110.7|74.3|
73974455|NCT04899674|147493790|OTHER||Ratio of gMeans [%]|95.1|||||TWO_SIDED|90.0|86.7|104.3|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])=13.9."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA). The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||104.3|86.7|
73974456|NCT05155306|147493799|OTHER||Geometric mean ratio [%]|89.1|||||TWO_SIDED|90.0|79.5|99.7|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.067.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||99.7|79.5|
73941113|NCT00608582|147414189|SUPERIORITY_OR_OTHER||||||<|0.835||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||<0.835
73941114|NCT00993655|147414190|SUPERIORITY|||||||0.065|||||||Cochran-Mantel-Haenszel|adjusting for stratification factors at randomization||Assume that the 9-month PD rate in IV arm (Arm 1) will be 40% (based on experience with data from NCIC CTG OV.16 and that of NCRI UK). The target sample size of 200 will enable the detection of a 19% difference between Arms 1 and 3 in 9 month progression disease rate post randomization with 80% power at two-sided 0.05 level.||||0.065
73941115|NCT00993655|147414191|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.27|TWO_SIDED|95.0|0.85|1.75|||Log Rank|Adjusting for stratification factors at randomization||||1.75|0.85|0.27
73941116|NCT00993655|147414192|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.4|TWO_SIDED|95.0|0.74|2.13|||Log Rank|Adjusting for stratification factors at randomization||||2.13|0.74|0.40
73941117|NCT03775200|147414193|OTHER|For this primary analysis, a sample size of 216 randomised participants (72:72:72) will provide 90% power at the alpha = 0.05 level to detect a 6-point difference in average MADRS total score between the optimal therapeutic dose of COMP360 and COMP360 1 mg, assuming the common standard deviation (SD) is 11.0.|Least Mean Square Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.86|<|0.05|TWO_SIDED|95.0|-10.2|-2.9|||Mixed Models Analysis|Hypothetical strategy estimand - missing not at random (MNAR) and missing at random (MAR) imputation for missing data.|LSM difference of COMP360 25 mg compared to COMP360 1 mg.|The primary analysis was the comparison between COMP360 (25 mg or 10 mg) versus COMP360 1 mg. The null hypothesis was that there was no difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg. The alternative hypothesis was that were was a difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg.||-2.9|-10.2|<0.05
73941118|NCT03775200|147414194|OTHER||Least Mean Square Difference|-5.6|STANDARD_ERROR_OF_MEAN|1.93|<|0.05|TWO_SIDED|95.0|-9.4|-1.8|||Mixed Models Analysis|Hypothetical strategy estimand - MNAR and MAR imputation for missing data.||Sensitivity analysis of the primary endpoint using the per-protocol analysis set.||-1.8|-9.4|<0.05
73974457|NCT05155306|147493799|OTHER||Geometric mean ratio [%]|98.1|||||TWO_SIDED|90.0|94.4|101.9|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.022.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||101.9|94.4|
73974458|NCT05155306|147493799|OTHER||Geometric mean ratio [%]|202.4|||||TWO_SIDED|90.0|180.1|227.5|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.069.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||227.5|180.1|
73941119|NCT04605978|147414195|SUPERIORITY||Mean Difference (Net)|2.44|||||TWO_SIDED|95.0|-0.61|5.49|||||Missing data and data post intercurrent event were imputed for the statistical analysis as specified in the statistical analysis plan.|||5.49|-0.61|
73941120|NCT01644734|147414224|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: no change in the total CAT score between baseline and after 3 months.||||<0.001
74008435|NCT02953639|147566545|SUPERIORITY||Treatment Difference|1.45||||0.164|TWO_SIDED|90.0|-0.27|3.17|||Mixed Models Analysis|||Week 12 Day 84 (LM I)||3.17|-0.27|0.164
74089111|NCT03575871|147731434|SUPERIORITY||Difference in Percentage|3.8||||0.081|TWO_SIDED|95.0|-0.7|8.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.4|-0.7|0.0810
73941121|NCT05159622|147414225|EQUIVALENCE|A net effect of 6 fluid oz/day (SD=1) was hypothesized among adult parents, assuming two sided alpha=0.05, power = 80%, and a minimum sample size of 60 adults.|Median Difference (Final Values)|3.2||||0.15|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05. P-value of the interaction between treatment group and change in beverage consumption (fl oz/day).|t-test, 2 sided|||||||0.15
73867677|NCT02921087|147280532|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for phoria, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.87
73941122|NCT05159622|147414226|EQUIVALENCE|This was an exploratory outcome.|Median Difference (Final Values)|0.07||||0.98|TWO_SIDED||||||t-test, 2 sided|||||||0.98
73941123|NCT05159622|147414227|EQUIVALENCE|This was an exploratory outcome and therefore statistical power was not based on a hypothesis of this outcome.|Median Difference (Final Values)|0.64||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
73941124|NCT05159622|147414228|EQUIVALENCE|Exploratory outcome as for infants/toddlers based on parent-report|Median Difference (Final Values)|0.14||||0.92|TWO_SIDED||||||t-test, 2 sided|||||||0.92
73941125|NCT05159622|147414229|EQUIVALENCE|Exploratory outcome|Median Difference (Final Values)|0.95||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
73941126|NCT03318523|147414234|SUPERIORITY|Adjusted mean, difference with placebo, 95% confidence interval (CI), and p-value were based on a mixed model for repeated measures (MMRM) model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.3||||0.8976|TWO_SIDED|95.0|-4.888|4.287|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||4.287|-4.888|0.8976
73867678|NCT00602420|147280614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67||||0.037|TWO_SIDED|95.0|0.1|3.24|||t-test, 2 sided|||Tested at the two-sided 0.05 significance level.||3.24|0.10|0.037
73867679|NCT00602420|147280614|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Tested at the two-sided 0.05 significance level.||||0.007
73867680|NCT03592368|147280757|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73867681|NCT03592368|147280759|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
73867682|NCT03592368|147280760|SUPERIORITY|||||||0.12|||||||t-test, 1 sided|||||||0.12
73867683|NCT01618695|147280763|SUPERIORITY||Median Difference (Final Values)|-5.09||||0.233|TWO_SIDED|95.0|-14.112|4.519|||ANCOVA||Median Difference to placebo and the 95 percent (%) confidence interval are based on the Hodges-Lehmann method.|||4.519|-14.112|0.2330
73867684|NCT01618695|147280763|SUPERIORITY||Median Difference (Final Values)|-16.45||||0.0003|TWO_SIDED|95.0|-25.683|-7.251|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-7.251|-25.683|0.0003
73941127|NCT03318523|147414234|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.5||||0.796|TWO_SIDED|95.0|-3.31|4.312|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||4.312|-3.310|0.7960
73941128|NCT03318523|147414234|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.08||||0.9695|TWO_SIDED|95.0|-3.805|3.956|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||3.956|-3.805|0.9695
73941129|NCT03318523|147414235|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.28||||0.9093|TWO_SIDED|95.0|-5.035|4.483|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||4.483|-5.035|0.9093
73941130|NCT03318523|147414235|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|1.55||||0.4327|TWO_SIDED|95.0|-2.336|5.44|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||5.440|-2.336|0.4327
73867685|NCT01618695|147280763|SUPERIORITY||Median Difference (Final Values)|-24.95|||<|0.0001|TWO_SIDED|95.0|-33.878|-16.235|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-16.235|-33.878|<0.0001
73867686|NCT01618695|147280764|SUPERIORITY|||||||0.3954|||||||Cochran-Mantel-Haenszel|||||||0.3954
73867687|NCT01618695|147280764|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||||||0.0005
73867688|NCT01618695|147280764|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73867689|NCT01618695|147280765|SUPERIORITY||Median Difference (Final Values)|-8.27||||0.0552|TWO_SIDED|95.0|-18.067|1.671|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||1.671|-18.067|0.0552
73867690|NCT01618695|147280765|SUPERIORITY||Median Difference (Final Values)|-21.21|||<|0.0001|TWO_SIDED|95.0|-30.941|-11.368|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-11.368|-30.941|<0.0001
73867691|NCT01618695|147280765|SUPERIORITY||Median Difference (Final Values)|-28.65|||<|0.0001|TWO_SIDED|95.0|-37.698|-19.794|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-19.794|-37.698|<0.0001
73867692|NCT00921843|147280807|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73867693|NCT02870101|147280808|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|94.7|||||TWO_SIDED|95.0|90.7|97.0|||||PPA estimated with two-sided 95% score confidence interval.|||97.0|90.7|
73867694|NCT02870101|147280808|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||TWO_SIDED|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.|||99.1|98.2|
73867695|NCT02870101|147280809|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|91.2|||||TWO_SIDED|95.0|86.5|94.4|||||PPA estimated with two-sided 95% score confidence interval.|||94.4|86.5|
73867696|NCT02870101|147280809|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||TWO_SIDED|95.0|99.3|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.3|
73867697|NCT02870101|147280810|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|95.1|||||TWO_SIDED|95.0|91.3|97.3|||||PPA estimated with two-sided 95% score confidence interval.|||97.3|91.3|
73867698|NCT02870101|147280810|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||TWO_SIDED|95.0|98.3|99.2|||||NPA estimated with two-sided 95% score confidence interval.|||99.2|98.3|
73867699|NCT02870101|147280811|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|96.5|||||TWO_SIDED|95.0|92.9|98.3|||||PPA estimated with two-sided 95% score confidence interval.|||98.3|92.9|
73941131|NCT03318523|147414235|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.17||||0.933|TWO_SIDED|95.0|-4.051|3.719|||Mixed Model with repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||3.719|-4.051|0.9330
73941132|NCT03318523|147414237|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.41||||0.8828|TWO_SIDED|95.0|-5.013|5.825|||Mixed Model for Repeated Measures|||||5.825|-5.013|0.8828
73941133|NCT03318523|147414237|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.84||||0.7019|TWO_SIDED|95.0|-3.458|5.128|||Mixed Model for Repeated Measure|||||5.128|-3.458|0.7019
73974459|NCT05155306|147493799|OTHER||Geometric mean ratio [%]|173.8|||||TWO_SIDED|90.0|158.3|190.8|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.055.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||190.8|158.3|
73867700|NCT02870101|147280811|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.2|||||TWO_SIDED|95.0|98.8|99.5|||||NPA estimated with two-sided 95% score confidence interval.|||99.5|98.8|
73867701|NCT02870101|147280812|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|84.8|||||TWO_SIDED|95.0|79.4|89.0|||||PPA estimated with two-sided 95% score confidence interval.|||89.0|79.4|
73974460|NCT05155306|147493800|OTHER||Geometric mean ratio [%]|83.0|||||TWO_SIDED|90.0|69.6|99.0|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.106.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||99.0|69.6|
74008436|NCT02953639|147566545|SUPERIORITY||Treatment Difference|0.56||||0.559|TWO_SIDED|90.0|-1.02|2.14|||Mixed Models Analysis|||Week 24 Day 168 (LM I)||2.14|-1.02|0.559
74008437|NCT02953639|147566545|SUPERIORITY||Treatment Difference|0.12||||0.912|TWO_SIDED|90.0|-1.7|1.94|||Mixed Models Analysis|||Week 12 Day 84 (LM II)||1.94|-1.70|0.912
73867702|NCT02870101|147280812|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.5|||||TWO_SIDED|95.0|99.2|99.7|||||NPA estimated with two-sided 95% score confidence interval.|||99.7|99.2|
73867703|NCT02870101|147280813|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|88.3|||||TWO_SIDED|95.0|83.2|92.0|||||PPA estimated with two-sided 95% score confidence interval.|||92.0|83.2|
73941134|NCT03318523|147414237|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.99||||0.6519|TWO_SIDED|95.0|-3.323|5.301|||Mixed Model for Repeated Measures|||||5.301|-3.323|0.6519
73941135|NCT03318523|147414239|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.53||||0.4327|TWO_SIDED|95.0|-1.851|0.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||0.794|-1.851|0.4327
73941136|NCT03318523|147414239|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.13||||0.8155|TWO_SIDED|95.0|-0.965|1.225|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||1.225|-0.965|0.8155
73941137|NCT03318523|147414239|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.22||||0.7015|TWO_SIDED|95.0|-0.899|1.334|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||1.334|-0.899|0.7015
73974461|NCT05155306|147493800|OTHER||Geometric mean ratio [%]|99.7|||||TWO_SIDED|90.0|88.7|112.0|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.070.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.0|88.7|
73974462|NCT05155306|147493800|OTHER||Geometric mean ratio [%]|153.6|||||TWO_SIDED|90.0|126.0|187.3|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.121.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||187.3|126.0|
73974463|NCT05155306|147493800|OTHER||Geometric mean ratio [%]|121.4|||||TWO_SIDED|90.0|99.6|147.8|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.120.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||147.8|99.6|
73941138|NCT03318523|147414240|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-1.03||||0.1038|TWO_SIDED|95.0|-2.276|0.213|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||0.213|-2.276|0.1038
73941139|NCT03318523|147414240|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.09||||0.8689|TWO_SIDED|95.0|-0.933|1.103|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||1.103|-0.933|0.8689
74089112|NCT03575871|147731434|SUPERIORITY||Difference in Percentage|5.2||||0.0419|TWO_SIDED|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.1|0.3|0.0419
74089113|NCT03575871|147731434|SUPERIORITY||Difference in Percentage|7.0||||0.018|TWO_SIDED|95.0|1.8|12.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.2|1.8|0.0180
73974464|NCT05155306|147493801|OTHER||Geometric mean ratio [%]|89.9|||||TWO_SIDED|90.0|80.4|100.4|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.066.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.4|80.4|
73974465|NCT05155306|147493801|OTHER||Geometric mean ratio [%]|100.4|||||TWO_SIDED|90.0|96.8|104.1|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.021.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.1|96.8|
74008438|NCT02953639|147566545|SUPERIORITY||Treatment Difference|-0.36||||0.706|TWO_SIDED|90.0|-1.93|1.22|||Mixed Models Analysis|||Week 24 Day 168 (LM II)||1.22|-1.93|0.706
73941140|NCT03318523|147414240|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.01||||0.982|TWO_SIDED|95.0|-1.026|1.003|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||1.003|-1.026|0.9820
73941141|NCT03318523|147414240|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.26||||0.693|TWO_SIDED|95.0|-1.563|1.04|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||1.040|-1.563|0.6930
73941142|NCT03318523|147414240|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.03||||0.9606|TWO_SIDED|95.0|-1.053|1.001|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||1.001|-1.053|0.9606
73941143|NCT03318523|147414240|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.24||||0.6512|TWO_SIDED|95.0|-1.269|0.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||0.794|-1.269|0.6512
73941144|NCT03318523|147414241|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.44||||0.5497|TWO_SIDED|95.0|-1.889|1.007|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.007|-1.889|0.5497
73974466|NCT05155306|147493801|OTHER||Geometric mean ratio [%]|202.6|||||TWO_SIDED|90.0|179.6|228.5|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.072.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||228.5|179.6|
73974467|NCT05155306|147493801|OTHER||Geometric mean ratio [%]|172.3|||||TWO_SIDED|90.0|158.2|187.7|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.050.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||187.7|158.2|
73974468|NCT00650078|147493816|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.001|TWO_SIDED|95.0|1.39|3.64||The p-value was based on logistic regression with treatment, geographic region, gender, and median age class as factors.|Regression, Logistic|||||3.64|1.39|0.0010
73941145|NCT03318523|147414241|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.0||||0.998|TWO_SIDED|95.0|-1.2|1.197|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.197|-1.200|0.9980
73974469|NCT00650078|147493817|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.6||||0.0015|TWO_SIDED|95.0|-31.7|-6.1||Wilcoxon Rank Sum Test p-value|Hodges-Lehman method|The difference between the treatment groups was assessed using the median and the 95% CI of the median computed using the Hodges Lehmann method.||||-6.1|-31.7|0.0015
73974470|NCT00195403|147493822|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline in PGA at Month 3 was evaluated using paired t-test.||||<0.0001
73974471|NCT00195403|147493823|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline in number of joints with tenderness, pain, and limitation of motion or swelling at Month 3 were evaluated using paired t-test.||||<0.0001
74008439|NCT02953639|147566546|SUPERIORITY||Treatment Difference|1.04||||0.527|TWO_SIDED|90.0|0.94|1.15|||Mixed Models Analysis|||Week 12 Day 84||1.15|0.94|0.527
74008440|NCT02953639|147566546|SUPERIORITY||Treatment Difference|1.04||||0.636|TWO_SIDED|90.0|0.92|1.17|||Mixed Models Analysis|||Week 24 Day 168||1.17|0.92|0.636
74008441|NCT02953639|147566547|SUPERIORITY||Treatment Difference|-1.36||||0.323|TWO_SIDED|90.0|-3.63|0.91|||Mixed Models Analysis|||Week 12 Day 84||0.91|-3.63|0.323
74008442|NCT02953639|147566547|SUPERIORITY||Treatment Difference|-0.95||||0.579|TWO_SIDED|90.0|-3.77|1.88|||Mixed Models Analysis|||Week 24 Day 168||1.88|-3.77|0.579
74008443|NCT02953639|147566548|SUPERIORITY||Treatment Difference|-0.67||||0.493|TWO_SIDED|90.0|-2.27|0.94|||Mixed Models Analysis|||Week 12 Day 84||0.94|-2.27|0.493
74008444|NCT02953639|147566548|SUPERIORITY||Treatment Difference|-0.12||||0.926|TWO_SIDED|90.0|-2.32|2.07|||Mixed Models Analysis|||Week 24 Day 168||2.07|-2.32|0.926
74008445|NCT02953639|147566549|SUPERIORITY||Treatment Difference|-0.02||||0.839|TWO_SIDED|90.0|-0.22|0.17|||Mixed Models Analysis|||Week 12 Day 84||0.17|-0.22|0.839
74008446|NCT02953639|147566549|SUPERIORITY||Treatment Difference|-0.06||||0.625|TWO_SIDED|90.0|-0.27|0.15|||Mixed Models Analysis|||Week 24 Day 168||0.15|-0.27|0.625
73941146|NCT03318523|147414241|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.15||||0.8069|TWO_SIDED|95.0|-1.374|1.07|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.070|-1.374|0.8069
73974472|NCT01260896|147493824|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.84|||||TWO_SIDED|90.0|100.54|113.54|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||113.54|100.54|
73974473|NCT01260896|147493825|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.34|||||TWO_SIDED|90.0|100.37|110.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||110.55|100.37|
73974474|NCT01260896|147493826|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.12|||||TWO_SIDED|90.0|97.8|108.73|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.73|97.80|
74008447|NCT02953639|147566550|SUPERIORITY||Treatment Difference|-0.03||||0.865|TWO_SIDED|90.0|-0.28|0.23|||Mixed Models Analysis|||Week 12 Day 84||0.23|-0.28|0.865
74008448|NCT02953639|147566550|SUPERIORITY||Treatment Difference|-0.01||||0.964|TWO_SIDED|90.0|-0.31|0.29|||Mixed Models Analysis|||Week 24 Day 168||0.29|-0.31|0.964
74008449|NCT02953639|147566551|SUPERIORITY||Treatment Difference|3.27||||0.142|TWO_SIDED|90.0|-0.4|6.95|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Cognition \& Vitality Score)||6.95|-0.40|0.142
74008450|NCT02953639|147566551|SUPERIORITY||Treatment Difference|-2.32||||0.416|TWO_SIDED|90.0|-7.04|2.4|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Cognition \& Vitality Score)||2.40|-7.04|0.416
74008451|NCT02953639|147566551|SUPERIORITY||Treatment Difference|1.98||||0.394|TWO_SIDED|90.0|-1.86|5.83|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Psychosocial Score)||5.83|-1.86|0.394
74008452|NCT02953639|147566551|SUPERIORITY||Treatment Difference|0.71||||0.776|TWO_SIDED|90.0|-3.44|4.87|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Psychosocial Score)||4.87|-3.44|0.776
74008453|NCT02953639|147566551|SUPERIORITY||Treatment Difference|2.43||||0.254|TWO_SIDED|90.0|-1.09|5.94|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Total Score)||5.94|-1.09|0.254
74008454|NCT02953639|147566551|SUPERIORITY||Treatment Difference|-0.57||||0.816|TWO_SIDED|90.0|-4.64|3.5|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Total Score)||3.50|-4.64|0.816
74008455|NCT01830855|147566558|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.93|1.14||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.14|0.93|
74008456|NCT01830855|147566558|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.92|1.13||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.13|0.92|
74008457|NCT01830855|147566558|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.88|1.12||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.12|0.88|
74008458|NCT01830855|147566558|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.85|1.06||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.||1.06|0.85|
74008459|NCT01830855|147566558|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.86|1.06||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.||1.06|0.86|
74008460|NCT01830855|147566558|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.88|1.14||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948||1.14|0.88|
74008461|NCT03523728|147566606|SUPERIORITY||Relative difference|21.32|||=|0.1367|TWO_SIDED|95.0|-5.77|58.22|||linear mixed effect model|||||58.22|-5.77|=0.1367
74008462|NCT03523728|147566606|SUPERIORITY||Relative difference|0.34|||=|0.9812|TWO_SIDED|95.0|-24.57|33.36|||linear mixed effect model|||||33.36|-24.57|=0.9812
74008463|NCT03523728|147566607|SUPERIORITY||Relative difference|101.32|||=|0.0005|TWO_SIDED|95.0|35.63|233.72|||linear mixed effect model|||||233.72|35.63|=0.0005
74008464|NCT03523728|147566607|SUPERIORITY||Relative difference|104.17|||=|0.0002|TWO_SIDED|95.0|39.54|236.45|||linear mixed effect model|||||236.45|39.54|=0.0002
73867704|NCT02870101|147280813|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||TWO_SIDED|95.0|99.2|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.2|
73941147|NCT03318523|147414242|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.21||||0.7968|TWO_SIDED|95.0|-1.786|1.372|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.372|-1.786|0.7968
73941148|NCT03318523|147414242|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.53||||0.4211|TWO_SIDED|95.0|-0.766|1.827|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.827|-0.766|0.4211
73941149|NCT03318523|147414242|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.15||||0.8166|TWO_SIDED|95.0|-1.448|1.143|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.143|-1.448|0.8166
73941150|NCT03318523|147414242|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.53||||0.5535|TWO_SIDED|95.0|-2.31|1.24|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.240|-2.310|0.5535
73974475|NCT01260896|147493827|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|114.21|||||TWO_SIDED|90.0|109.29|119.35|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||119.35|109.29|
73974476|NCT01260896|147493828|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|108.26|||||TWO_SIDED|90.0|104.84|111.79|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.79|104.84|
73974477|NCT01260896|147493829|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.75|||||TWO_SIDED|90.0|92.92|102.85|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.85|92.92|
73974478|NCT05601882|147493830|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|11.0|||<|0.0001|TWO_SIDED|95.0|6.6|15.5|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||15.5|6.6|<0.0001
73941151|NCT03318523|147414242|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.52||||0.4654|TWO_SIDED|95.0|-0.881|1.922|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.922|-0.881|0.4654
73867705|NCT02870101|147280814|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|95.9|||||TWO_SIDED|95.0|86.3|98.9|||||PPA estimated with two-sided 95% score confidence interval.|||98.9|86.3|
73941152|NCT03318523|147414242|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.36||||0.6184|TWO_SIDED|95.0|-1.051|1.763|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.763|-1.051|0.6184
73941153|NCT03318523|147414243|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.59||||0.7274|TWO_SIDED|95.0|-2.742|3.925|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||3.925|-2.742|0.7274
73941154|NCT03318523|147414243|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.66||||0.6385|TWO_SIDED|95.0|-2.094|3.411|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||3.411|-2.094|0.6385
73941155|NCT03318523|147414243|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.1||||0.9467|TWO_SIDED|95.0|-2.718|2.91|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||2.910|-2.718|0.9467
73941156|NCT03318523|147414244|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.85||||0.6112|TWO_SIDED|95.0|-2.423|4.114|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||4.114|-2.423|0.6112
73941157|NCT03318523|147414244|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.86||||0.527|TWO_SIDED|95.0|-1.806|3.52|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||3.520|-1.806|0.5270
73941158|NCT03318523|147414244|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.06||||0.9673|TWO_SIDED|95.0|-2.608|2.719|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||2.719|-2.608|0.9673
73941159|NCT03318523|147414244|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.65||||0.7455|TWO_SIDED|95.0|-3.274|4.569|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||4.569|-3.274|0.7455
73941160|NCT03318523|147414244|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.1||||0.9506|TWO_SIDED|95.0|-3.192|2.997|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||2.997|-3.192|0.9506
73941161|NCT03318523|147414244|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.69||||0.6643|TWO_SIDED|95.0|-2.422|3.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||3.794|-2.422|0.6643
73941162|NCT03318523|147414245|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.005||||0.8274|TWO_SIDED|95.0|-0.0548|0.0438|||Mixed Model for Repeated Measures|||||0.0438|-0.0548|0.8274
74008465|NCT03523728|147566608|SUPERIORITY||Relative difference|51.01|||=|0.0197|TWO_SIDED|95.0|7.01|125.45|||linear mixed effect model|||||125.45|7.01|=0.0197
73867706|NCT02870101|147280814|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||TWO_SIDED|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.4|
73941163|NCT03318523|147414245|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.009||||0.6671|TWO_SIDED|95.0|-0.0504|0.0323|||Mixed Model for Repeated Measures|||||0.0323|-0.0504|0.6671
73941164|NCT03318523|147414245|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.033||||0.1313|TWO_SIDED|95.0|-0.0751|0.0098|||Mixed Model for Repeated Measures|||||0.0098|-0.0751|0.1313
73974479|NCT05601882|147493831|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|18.4|||<|0.0001|TWO_SIDED|95.0|12.5|24.2|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||24.2|12.5|<0.0001
73974480|NCT05601882|147493832|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|14.7|||<|0.0001|TWO_SIDED|95.0|9.4|20.0|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||20.0|9.4|<0.0001
73974481|NCT05601882|147493833|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|16.6|||<|0.0001|TWO_SIDED|95.0|10.2|23.0|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||23.0|10.2|<0.0001
73974482|NCT05601882|147493834|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|13.2|||<|0.0001|TWO_SIDED|95.0|9.6|16.9|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||16.9|9.6|<0.0001
73867707|NCT02870101|147280815|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|86.0|||||TWO_SIDED|95.0|80.9|89.9|||||PPA estimated with two-sided 95% score confidence interval.|||89.9|80.9|
73974483|NCT05601882|147493835|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|6.4|||<|0.0001|TWO_SIDED|95.0|3.8|9.1|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||9.1|3.8|<0.0001
73974484|NCT05601882|147493836|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|14.1|||<|0.0001|TWO_SIDED|95.0|9.4|18.8|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||18.8|9.4|<0.0001
73974485|NCT05601882|147493837|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|18.6|||<|0.0001|TWO_SIDED|95.0|13.9|23.3|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||23.3|13.9|<0.0001
73974486|NCT05601882|147493838|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.4|13.1|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||13.1|5.4|<0.0001
74008466|NCT03523728|147566608|SUPERIORITY||Relative difference|46.36|||=|0.0337|TWO_SIDED|95.0|3.21|119.01|||linear mixed effect model|||||119.01|3.21|=0.0337
74008467|NCT03523728|147566610|SUPERIORITY||Least square mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.23|=|0.6374|TWO_SIDED|95.0|-0.342|0.556|||Mixed effect model with repeated measure|||||0.556|-0.342|=0.6374
73941165|NCT03318523|147414246|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.009||||0.7079|TWO_SIDED|95.0|-0.0562|0.0382|||Mixed Model for Repeated Measures|||||0.0382|-0.0562|0.7079
73867708|NCT02870101|147280815|OTHER|Estimated Negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.3|||||TWO_SIDED|95.0|98.9|99.6|||||NPA estimated with two-sided 95% score confidence interval.|||99.6|98.9|
73974487|NCT04121741|147493850|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.42||0.864|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for FMD% (singing video intervention compared to control) is shown. Estimates of FMD% for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.864
73941166|NCT03318523|147414246|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|0.0||||0.9835|TWO_SIDED|95.0|-0.04|0.0392|||Mixed Model for Repeated Measures|||||0.0392|-0.0400|0.9835
73941167|NCT03318523|147414246|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.027||||0.1869|TWO_SIDED|95.0|-0.0682|0.0134|||Mixed Model for Repeated Measures|||||0.0134|-0.0682|0.1869
73941168|NCT03318523|147414247|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.008||||0.7585|TWO_SIDED|95.0|-0.0625|0.0456|||Mixed Model for Repeated Measures|||||0.0456|-0.0625|0.7585
73941169|NCT03318523|147414247|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|0.006||||0.7808|TWO_SIDED|95.0|-0.0391|0.052|||Mixed Model for Repeated Measures|||||0.0520|-0.0391|0.7808
73941170|NCT03318523|147414247|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.022||||0.3532|TWO_SIDED|95.0|-0.0691|0.0248|||Mixed Model for Repeated Measures|||||0.0248|-0.0691|0.3532
73941171|NCT03581981|147414250|SUPERIORITY|see statistical plan|Mean Difference (Final Values)|-3.6||||0.33|TWO_SIDED|95.0|-10.7|3.6|||Mixed Models Analysis|||||3.6|-10.7|0.33
73941172|NCT03581981|147414251|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.89|TWO_SIDED||||||Mixed Models Analysis|||||||0.89
74008468|NCT03523728|147566610|SUPERIORITY||Least square mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.22|=|0.256|TWO_SIDED|95.0|-0.689|0.185|||Mixed effect model with repeated measure|||||0.185|-0.689|=0.2560
74008469|NCT03523728|147566611|SUPERIORITY||Least square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.42|=|0.79|TWO_SIDED|95.0|-0.971|0.747|||Mixed effect model with repeated measure|||||0.747|-0.971|=0.7900
73941173|NCT03581981|147414252|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.89|TWO_SIDED||||||Mixed Models Analysis|||||||0.89
73941174|NCT03581981|147414253|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.99|TWO_SIDED|95.0|-3.6|3.6|||Mixed Models Analysis|||||3.6|-3.6|0.99
73941175|NCT03581981|147414254|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.52|TWO_SIDED|95.0|-7.3|3.7|||Mixed Models Analysis|||||3.7|-7.3|0.52
73941176|NCT03581981|147414255|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5|TWO_SIDED|95.0|-1.4|2.9|||Mixed Models Analysis|||||2.9|-1.4|0.50
73941177|NCT03581981|147414256|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
73941178|NCT03581981|147414257|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
73941179|NCT03581981|147414258|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
73941180|NCT03581981|147414259|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
73941181|NCT03581981|147414260|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||0.41
73941182|NCT03581981|147414261|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||0.41
73941183|NCT03384173|147414269|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73941184|NCT03384173|147414270|OTHER|Correlation, Pearson r|Pearson r correlation|0.16||||0.17|TWO_SIDED|95.0|-0.07|0.37|||Pearson r correlation|||||0.37|-0.07|0.17
73941185|NCT03384173|147414271|OTHER|Correlation, Pearson r|Pearson r correlation|0.12||||0.32|TWO_SIDED|95.0|-0.11|0.33|||Pearson r correlation|||||0.33|-0.11|0.32
73941186|NCT03384173|147414273|OTHER|Mann Whitney U non parametric test|||||<|0.01||||||"A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.~A-priori threshold p\<0.05 for 'subgroup 30-39.99%' vs 'baseline value before caffeine dose'."|Wilcoxon (Mann-Whitney)|||Control group is Secondary analysis #4, baseline values before caffeine dose.||||<0.01
73941187|NCT03384173|147414274|OTHER|Mann Whitney U non parametric test|||||<|0.001||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Control group is secondary outcome #4, baseline values before caffeine dose||||<0.001
74008470|NCT03523728|147566611|SUPERIORITY||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.32|=|0.6322|TWO_SIDED|95.0|-0.808|0.5|||Mixed effect model with repeated measure|||||0.500|-0.808|=0.6322
73867709|NCT02870101|147280816|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.2|||||TWO_SIDED|95.0|76.6|94.5|||||PPA estimated with two-sided 95% score confidence interval.|||94.5|76.6|
73867710|NCT02870101|147280816|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||TWO_SIDED|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.4|
73867711|NCT02870101|147280817|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.7|||||TWO_SIDED|95.0|83.9|92.3|||||PPA estimated with two-sided 95% score confidence interval.|||92.3|83.9|
73941188|NCT03384173|147414275|OTHER|Mann-Whitney U non parametric t test|||||<|0.01||||||"A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.~A-priori threshold p\<0.05 for 'subgroup \>60% ' vs 'baseline value before caffeine dose'."|Wilcoxon (Mann-Whitney)|||Comparison group is Secondary outcome #4, baseline caffeine values by subgroup||||<0.01
73941189|NCT03384173|147414276|OTHER||||||<|0.0001||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Comparison group is secondary outcome #4, baseline values before caffeine dose||||<0.0001
73941190|NCT03384173|147414277|OTHER|Mann Whitney U non-parametric t-test|||||<|0.05||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Comparison group is Secondary Outcome #4, baseline before dose of caffeine.||||<0.05
73941191|NCT00863655|147414293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.35|0.54|||Log Rank|||||0.54|0.35|<0.0001
73941192|NCT02157779|147414317|SUPERIORITY||Least Squares Mean Difference|-5.68||||0.017|TWO_SIDED|95.0|-10.32|-1.01||Threshold for statistical significance was 0.025.|ANCOVA|Method used: Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the HLM analyses.||-1.01|-10.32|.017
73974488|NCT04121741|147493850|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.42||0.913|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for FMD% (singing coach intervention compared to control) is shown. Estimates of FMD% for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.913
74008471|NCT03523728|147566612|SUPERIORITY||Least square mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.34|=|0.6245|TWO_SIDED|95.0|-0.506|0.839|||Mixed effect model with repeated measure|||||0.839|-0.506|=0.6245
74008472|NCT03523728|147566612|SUPERIORITY||Least square mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.33|=|0.2567|TWO_SIDED|95.0|-1.044|0.281|||Mixed effect model with repeated measure|||||0.281|-1.044|=0.2567
73867712|NCT02870101|147280817|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.7|||||TWO_SIDED|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.|||99.1|98.2|
73941193|NCT02157779|147414318|SUPERIORITY||Least Squares Mean Difference|-0.14||||0.19|TWO_SIDED|95.0|-0.33|0.06||The threshold for statistical significance was p=0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.||Population Description: All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the statistical analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|0.06|-0.33|0.19
73941194|NCT02157779|147414319|SUPERIORITY||Least Squares Mean Difference|-0.42||||0.011|TWO_SIDED|95.0|-0.75|-0.09||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||Population Description: All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|-0.09|-0.75|.011
73941195|NCT02157779|147414320|SUPERIORITY||Least Squares Mean Difference|-0.26||||0.16|TWO_SIDED|95.0|-0.63|0.11||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment, 3 month and/or 6 month follow-up) were included in the analyses.||0.11|-0.63|0.16
73941196|NCT02157779|147414321|SUPERIORITY||Least Squares Mean Difference|-11.65||||0.031|TWO_SIDED|95.0|-22.2|-1.09||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment), 3 month and/or 6 month follow-up) were included in the statistical analyses.||-1.09|-22.20|.031
74008473|NCT03523728|147566613|SUPERIORITY||Least square mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.68|=|0.2023|TWO_SIDED|95.0|-2.232|0.485|||Mixed effect model with repeated measure|||||0.485|-2.232|=0.2023
73941197|NCT02157779|147414322|SUPERIORITY||Least Squares Mean Difference|1.56||||0.004|TWO_SIDED|95.0|0.51|2.6||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.||All randomized participants with at least one post-baseline assessment (week 12 (end of treatment), 3 month, and/or 6 month follow-up) were used in the statistical analysis.|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|2.60|0.51|0.004
73941198|NCT02157779|147414323|SUPERIORITY||Least Squares Mean Difference|-2.15||||0.416|TWO_SIDED|95.0|-7.37|3.07||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI|All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.||3.07|-7.37|0.416
73941199|NCT02157779|147414324|SUPERIORITY||Least Squares Mean Difference|-13.72||||0.028|TWO_SIDED|95.0|-25.94|-1.5||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment were used in the analyses.||-1.50|-25.94|0.028
73941200|NCT02157779|147414325|SUPERIORITY|||||||0.13|||||||ANOVA|GLM Repeated Measures Analysis of Variance of means grouped by sessions 1-4, 5-8, and 9-12||All randomized participants with at least one DAR completed in each time frame (sessions 1-4, 5-8, and 9-12) were included in the analyses. The mean DAR scores for sessions 1-4, 5-8, and 9-12 were calculated and used as outcome variables in the GLM repeated measures ANOVA.||||0.13
73941201|NCT02157779|147414326|SUPERIORITY||Least Squares Mean Difference|-0.82||||0.03|TWO_SIDED|95.0|-1.578|-0.063||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (week 4, week 8, week 12 (end of treatment), 3 mo and/or 6 month follow-up) were included in the HLM analyses.||-0.063|-1.578|0.030
73941202|NCT02157779|147414327|SUPERIORITY||Least Squares Mean Difference|-0.085||||0.021|TWO_SIDED|95.0|-0.158|-0.011||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||-0.011|-0.158|0.021
73941203|NCT02157779|147414328|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.246|TWO_SIDED|95.0|-0.283|0.073||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were used in the HLM analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.||0.073|-0.283|0.246
73941204|NCT02157779|147414329|SUPERIORITY||Least Squares Mean Difference|-0.14||||0.036|TWO_SIDED|95.0|-0.27|-0.01||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment were used in the statistical analysis. Data were winsorized and log 10 transformed to counter high levels of skewness.||-0.01|-0.27|0.036
73941205|NCT02157779|147414330|SUPERIORITY||Least Squares Mean Difference|-0.026||||0.786|TWO_SIDED|95.0|-0.213|0.1614||Threshold for statistical significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||0.1614|-0.213|0.786
74008474|NCT03523728|147566613|SUPERIORITY||Least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.53|=|0.3205|TWO_SIDED|95.0|-1.61|0.537|||Mixed effect model with repeated measure|||||0.537|-1.610|=0.3205
73941206|NCT02157779|147414331|SUPERIORITY||Least Squares Mean Difference|-0.02||||0.744|TWO_SIDED|95.0|-0.18|0.13||Threshold for significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||0.13|-0.18|0.744
73941207|NCT02157779|147414332|SUPERIORITY||Least Squares Mean Difference|-1.85||||0.002|TWO_SIDED|95.0|-3.038|-0.663||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.||-0.663|-3.038|0.002
74008999|NCT01641237|147568703|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.17||||0.1898|TWO_SIDED|95.0|-1.09|5.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||5.43|-1.09|0.1898
74089114|NCT03575871|147731435|SUPERIORITY||Difference in LS mean|-30.2|||<|0.0001|TWO_SIDED|95.0|-38.1|-22.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-22.3|-38.1|<0.0001
74089115|NCT03575871|147731435|SUPERIORITY||Difference in LS mean|-42.3|||<|0.0001|TWO_SIDED|95.0|-50.3|-34.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-34.4|-50.3|<0.0001
74089116|NCT03575871|147731435|SUPERIORITY||Difference in LS mean|-29.9|||<|0.0001|TWO_SIDED|95.0|-38.1|-21.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-21.7|-38.1|<0.0001
73974489|NCT04121741|147493851|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.13||0.29|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for RHI (singing video intervention compared to control) is shown. Estimates of RHI for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.290
73941208|NCT02157779|147414333|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.186|TWO_SIDED|95.0|-2.518|0.524||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.||0.524|-2.518|0.186
73941209|NCT02157779|147414334|SUPERIORITY||Least Squares Mean Difference|1.26||||0.164|TWO_SIDED|95.0|-0.56|3.09||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|"All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||3.09|-0.560|0.164
73941210|NCT02157779|147414335|SUPERIORITY||Least Squares Mean Difference|1.33||||0.1|TWO_SIDED|95.0|-0.26|2.92||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|"All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||2.92|-0.26|0.100
73941211|NCT02157779|147414336|SUPERIORITY||Least Squares Mean Difference|-6.29||||0.06|TWO_SIDED|95.0|-12.85|0.27||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.||"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI, indicating less symptomatic distress.|0.27|-12.85|0.060
73941212|NCT02157779|147414337|SUPERIORITY||Least Squares Mean Difference|-3.271||||0.023|TWO_SIDED|95.0|-6.083|-0.458||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||-0.458|-6.083|0.023
73941213|NCT02157779|147414338|SUPERIORITY||Least Squares Mean Difference|-1.28||||0.23|TWO_SIDED|95.0|-3.39|0.82||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||0.82|-3.39|0.23
74089117|NCT03575871|147731435|SUPERIORITY||Difference in LS mean|-44.6|||<|0.0001|TWO_SIDED|95.0|-52.8|-36.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-36.3|-52.8|<0.0001
74089118|NCT03575871|147731435|SUPERIORITY||Difference in LS mean|-26.4|||<|0.0001|TWO_SIDED|95.0|-36.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.7|-36.2|<0.0001
74089119|NCT03575871|147731435|SUPERIORITY||Difference in LS mean|-40.2|||<|0.0001|TWO_SIDED|95.0|-50.0|-30.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-30.4|-50.0|<0.0001
74031182|NCT05070429|147615893|SUPERIORITY||Maximum likelihood (MLE)|-0.035||||0.92|TWO_SIDED|95.0|-0.727|0.657||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|generalized linear model (GLM)|generalized linear model (GLM) with an identity link|Confidence intervals and p-values were obtained using a bias-corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare average daily hours of hearing aid use at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the primary outcome.||0.657|-0.727|0.92
73941214|NCT02249819|147414340|EQUIVALENCE|Statistical analysis for mean change from baseline in naming accuracy in the anodal vs. sham tDCS conditions Null hypothesis is that there was no difference in mean change of naming accuracy between anodal and sham tDCS conditions. A significance level of 0.05 was used (two-sided).||||||0.694||||||The wilcoxon sign-ranked test was performed for this crossover design study in which subjects underwent measures across 2 study conditions (paired samples: mean change in anodal vs. sham condition). A significance level of 0.05 was used (two-sided).|wilcoxon sign-ranked test|Western Aphasia Battery used as a screening tool on admission only, to characterize level of severity. It was NOT an outcome measure.||||||0.694
73941215|NCT00831779|147414366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.97|STANDARD_ERROR_OF_MEAN|7.4685||0.0059|TWO_SIDED|95.0|5.75|36.1||Primary endpoint was tested at alpha=0.05|ANOVA|||||36.10|5.75|0.0059
73941216|NCT00831779|147414367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.13|STANDARD_ERROR_OF_MEAN|14.4984||0.0598|TWO_SIDED|95.0|-1.22|57.48||Secondary endpoint was tested following a sequential testing procedure at alpha=0.05|ANOVA|||||57.48|-1.22|0.0598
73974490|NCT04121741|147493851|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.462|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for RHI (singing coach intervention compared to control) is shown. Estimates of RHI for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.462
73974491|NCT04121741|147493852|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for fRHI (singing video intervention compared to control) is shown. Estimates of fRHI for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.005
73974492|NCT04121741|147493852|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.18||0.57|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for fRHI (singing coach intervention compared to control) is shown. Estimates of fRHI for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.570
73974493|NCT03473223|147493862|SUPERIORITY||Hazard Ratio (HR)|0.925||||0.121|TWO_SIDED|95.0|0.8126|1.0538||1-sided p-value.|Cox proportional hazards regression|||||1.0538|0.8126|0.121
73974494|NCT03473223|147493863|SUPERIORITY||Rate ratio|0.971||||0.341|TWO_SIDED|95.0|0.8442|1.1171||1-sided p-value|Negative binomial regression model|||||1.1171|0.8442|0.341
73974495|NCT03473223|147493864|SUPERIORITY||Hazard Ratio (HR)|0.907||||0.038|TWO_SIDED|95.0|0.8132|1.0106||1-sided p-value.|Cox proportional hazards regression|||||1.0106|0.8132|0.038
73974496|NCT03473223|147493865|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.069|TWO_SIDED|95.0|0.8511|1.0224||1-sided p-value.|Cox proportional hazards regression|||||1.0224|0.8511|0.069
73974497|NCT03473223|147493866|SUPERIORITY||Hazard Ratio (HR)|0.827||||0.074|TWO_SIDED|95.0|0.6399|1.0695||1-sided p-value.|Cox proportional hazards regression|||||1.0695|0.6399|0.074
73974498|NCT03473223|147493867|SUPERIORITY||Hazard Ratio (HR)|0.909||||0.113|TWO_SIDED|95.0|0.7801|1.0603||1-sided p-value.|Cox proportional hazards regression|||||1.0603|0.7801|0.113
73974499|NCT03473223|147493868|SUPERIORITY||Hazard Ratio (HR)|1.153||||0.767|TWO_SIDED|95.0|0.7867|1.6886||1-sided p-value.|Cox proportional hazards regression|||||1.6886|0.7867|0.767
73941217|NCT02436330|147414368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0615||||0.0967|TWO_SIDED|95.0|-0.1344|0.0115||We checked the distribution of bmiz changes between baseline and 6 months, and there is one subject from control group had bigger changes than others. After excluding this subject, the results are still similar with previous.|t-test, 2 sided|||||0.0115|-0.1344|0.0967
73941218|NCT02436330|147414369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0775||||0.0335|TWO_SIDED|95.0|-0.1485|-0.00652|||t-test, 2 sided|||||-0.00652|-0.1485|0.0335
73941219|NCT02436330|147414370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.991|TWO_SIDED|95.0|-5.2|5.1|||t-test, 2 sided|||||5.1|-5.2|0.991
73941220|NCT02436330|147414371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.851|TWO_SIDED|95.0|-9.0|11.0|||t-test, 2 sided|||||11|-9|0.851
73941221|NCT02436330|147414372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.501|TWO_SIDED|95.0|-11.7|5.8|||t-test, 2 sided|||||5.8|-11.7|0.501
73941222|NCT02436330|147414373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2971||||0.035|TWO_SIDED|95.0|0.0224|0.5718|||t-test, 2 sided|||||0.5718|0.0224|0.035
73941223|NCT02436330|147414374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9464||||0.2207|TWO_SIDED|95.0|-2.4954|0.6025|||t-test, 2 sided|||||0.6025|-2.4954|0.2207
74089120|NCT03575871|147731435|SUPERIORITY||Difference in LS mean|-31.4|||<|0.0001|TWO_SIDED|95.0|-43.1|-19.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-19.7|-43.1|<0.0001
73941224|NCT02436330|147414375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0491||||0.4164|TWO_SIDED|95.0|-3.6407|1.5425|||t-test, 2 sided|||||1.5425|-3.6407|0.4164
73867713|NCT02870101|147280818|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|84.0|||||TWO_SIDED|95.0|71.5|91.7|||||PPA estimated with two-sided 95% score confidence interval.|||91.7|71.5|
73941225|NCT02436330|147414376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2433.7||||0.812|TWO_SIDED|95.0|-18579.7|23447.2|||t-test, 2 sided|||||23447.2|-18579.7|0.812
73941226|NCT02436330|147414377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2837||||0.3326|TWO_SIDED|95.0|-0.3037|0.8711|||t-test, 2 sided|||||0.8711|-0.3037|0.3326
73941227|NCT02436330|147414378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2995||||0.1856|TWO_SIDED|95.0|-0.2051|0.8041|||t-test, 2 sided|||||0.8041|-0.2051|0.1856
73941228|NCT02436330|147414379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-247.9||||0.0849|TWO_SIDED|95.0|-531.7|35.8686|||t-test, 2 sided|||||35.8686|-531.7|0.0849
73941229|NCT02436330|147414380|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.2048||||0.176|TWO_SIDED|95.0|-10.3835|1.974|||t-test, 2 sided|||||1.9740|-10.3835|0.176
74008475|NCT00621751|147566626|OTHER||Median Difference (Final Values)|36.7||||0.6|TWO_SIDED|||||CBZ (up to 800 mg daily) vs placebo significantly improves behavior (Rasch NPI irritability \& aggression rated by observer) baseline to day-42 among individuals \>6 months post-traumatic brain injury and moderate-severe irritability.|ANCOVA|||The primary outcome was a composite measure of observer-rated NPI-I \& NPI-A domains transformed to a Rasch logit scale ranging 0 (best) to 100 (worse) units (i.e., observer-rated NPI-I/A Rasch construct scores). Mean day-42 observer-rated NPI-I/A Rasch construct scores were compared between the placebo vs. carbamazepine groups using ANCOVA with baseline score as covariate.||||0.60
73941230|NCT02436330|147414381|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.2151||||0.0247|TWO_SIDED|95.0|0.973|13.457|||t-test, 2 sided|||||13.457|0.973|0.0247
73941231|NCT02436330|147414382|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8169||||0.2764|TWO_SIDED|95.0|-2.4147|0.7808|||t-test, 2 sided|||||0.7808|-2.4147|0.2764
73941232|NCT02436330|147414383|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7958||||0.0008|TWO_SIDED|95.0|-1.235|-0.3566|||t-test, 2 sided|||||-0.3566|-1.2350|0.0008
73941233|NCT02436330|147414384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7024||||0.6974|TWO_SIDED|95.0|-2.9377|4.3425|||t-test, 2 sided|||||4.3425|-2.9377|0.6974
73941234|NCT02436330|147414386|SUPERIORITY_OR_OTHER|||||||0.2122|TWO_SIDED||||||t-test, 2 sided|||||||0.2122
73941235|NCT02436330|147414387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.61||||0.1265|TWO_SIDED|95.0|-1.15|8.33|||t-test, 2 sided|||||8.33|-1.15|0.1265
74089121|NCT03575871|147731435|SUPERIORITY||Difference in LS mean|-44.7|||<|0.0001|TWO_SIDED|95.0|-56.4|-33.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-33.0|-56.4|<0.0001
73941236|NCT02436330|147414388|SUPERIORITY_OR_OTHER|||||||0.3671|TWO_SIDED||||||t-test, 2 sided|||||||0.3671
73941237|NCT02436330|147414389|SUPERIORITY_OR_OTHER|||||||0.4892|TWO_SIDED||||||t-test, 2 sided|||||||0.4892
73941238|NCT01375114|147414391|OTHER|||||||0.67|||||||Chi-squared|||||||0.67
73941239|NCT01375114|147414392|OTHER|||||||0.71|||||||Chi-squared|||||||0.71
73941240|NCT01375114|147414393|OTHER|||||||0.34|||||||Chi-squared|||||||0.34
73941241|NCT01375114|147414394|OTHER|||||||0.36|||||||Chi-squared|||||||0.36
73941242|NCT01375114|147414395|OTHER|||||||0.56|||||||Chi-squared|||||||0.56
73941243|NCT00162370|147414400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||Regression, Cox|||The null hypothesis evaluated is that the scores are not associated with outcome. Of the two measures, wall motion index is considered to be the primary endpoint measure. The cardiac event rate will be summarized by categorical levels of wall motion index score and the difference in wall motion index score.||||0.014
73941244|NCT00162370|147414401|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Regression, Cox|||||||<0.0001
73941245|NCT01596582|147414433|SUPERIORITY|||||||0.4|||||||Chi-squared|||||||0.40
73941246|NCT01596582|147414434|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
73941247|NCT01596582|147414435|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73941248|NCT01596582|147414436|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73941249|NCT01596582|147414437|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
73941250|NCT01596582|147414438|SUPERIORITY||||||>|0.05||||||The p-value for each comparison was non-significanct.|Wilcoxon (Mann-Whitney)|||||||>0.05
73941251|NCT01596582|147414439|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
73941252|NCT01596582|147414440|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
73941253|NCT01596582|147414441|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73941254|NCT01596582|147414442|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
73941255|NCT03923933|147414447|SUPERIORITY||||||<|0.001|||||||ANOVA|anova repeated measures||||||<0.001
73941256|NCT03923933|147414448|SUPERIORITY|||||||0.006|||||||ANOVA|Repeated Measures||||||0.006
73941257|NCT03923933|147414449|SUPERIORITY|||||||0.371|||||||ANOVA|||||||0.371
73941258|NCT03923933|147414450|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73941259|NCT03923933|147414452|SUPERIORITY|||||||0.028|||||||ANOVA|||||||0.028
73941260|NCT03923933|147414453|SUPERIORITY|||||||0.018|||||||ANOVA|||||||0.018
73941261|NCT00419263|147414454|SUPERIORITY_OR_OTHER|||||||0.377|TWO_SIDED||||||Regression, Cox|P-value is based on the treatment parameter from the Cox Regression Model including treatment, current smoking behavior, and geographic region.||||||0.377
73941262|NCT00419263|147414455|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank|||||||0.007
74089122|NCT03575871|147731436|SUPERIORITY||Difference in LS mean|-26.5|||<|0.0001|TWO_SIDED|95.0|-35.5|-17.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.5|-35.5|<0.0001
74089123|NCT03575871|147731436|SUPERIORITY||Difference in LS mean|-34.1|||<|0.0001|TWO_SIDED|95.0|-43.1|-25.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-25.1|-43.1|<0.0001
74089124|NCT03575871|147731436|SUPERIORITY||Difference in LS mean|-29.7|||<|0.0001|TWO_SIDED|95.0|-39.0|-20.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-20.4|-39.0|<0.0001
73867714|NCT02870101|147280818|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.8|||||TWO_SIDED|95.0|99.5|99.9|||||NPA estimated with two-sided 95% score confidence interval.|||99.9|99.5|
73941263|NCT00419263|147414456|SUPERIORITY_OR_OTHER|||||||0.537|TWO_SIDED|||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank|||||||0.537
73941264|NCT00419263|147414457|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.002
73941265|NCT00419263|147414458|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||< 0.001
73974500|NCT00115934|147493892|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-10.1||||0.013||95.0|-17.8|-2.4|||Fisher Exact||The risk difference is defined as the percent of subjects with events in the RVPAS group minus the percent of subjects with events in the MBTS group.|The original sample size of 456 was based on 85% power, with a two-sided, two sample test of proportions (anticipating 28% MBTS subjects with events, 16% RVPAS subjects with events), and an alpha of 0.05. The critical p-value was 0.044 because four interim analyses were performed. The target trial size was increased from 466 to 554 to account for crossovers. The stopping boundary was crossed at the 4th interim look; however, the trial was not halted, because all subjects were enrolled.||-2.4|-17.8|0.013
73974501|NCT00115934|147493893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||Log Rank|||||||0.06
73974502|NCT00115934|147493894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.09
73941266|NCT00419263|147414459|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.409
73941267|NCT00419263|147414460|SUPERIORITY_OR_OTHER|||||||0.327|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.327
73941268|NCT00540124|147414467|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.073
73974503|NCT00115934|147493895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.009
73974504|NCT00115934|147493896|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.07
74089125|NCT03575871|147731436|SUPERIORITY||Difference in LS mean|-40.5|||<|0.0001|TWO_SIDED|95.0|-49.8|-31.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-31.1|-49.8|<0.0001
73941269|NCT00540124|147414467|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.186
73941270|NCT00540124|147414468|SUPERIORITY_OR_OTHER|||||||0.155||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.155
73941271|NCT00540124|147414468|SUPERIORITY_OR_OTHER|||||||0.155||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.155
73974505|NCT00115934|147493897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
73974506|NCT00115934|147493898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test||||0.004
73941272|NCT00540124|147414468|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.108
73974507|NCT00115934|147493899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.10
73974508|NCT00115934|147493900|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73974509|NCT00115934|147493901|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
73941273|NCT00540124|147414468|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.112
73941274|NCT00540124|147414469|SUPERIORITY_OR_OTHER|||||||0.137||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.137
73941275|NCT00540124|147414469|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.009
73941276|NCT00540124|147414469|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.118
73941277|NCT00540124|147414469|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.018
73941278|NCT00540124|147414469|SUPERIORITY_OR_OTHER|||||||0.207||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.207
73941279|NCT00540124|147414469|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.581
73941280|NCT00540124|147414470|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.306
73941281|NCT00540124|147414470|SUPERIORITY_OR_OTHER|||||||0.762||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.762
73941282|NCT00540124|147414470|SUPERIORITY_OR_OTHER|||||||0.203||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.203
73941283|NCT00540124|147414470|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.464
73941284|NCT00540124|147414470|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.169
73941285|NCT00540124|147414470|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.243
73941286|NCT00540124|147414471|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.206
73941287|NCT00540124|147414471|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.457
73941288|NCT00540124|147414471|SUPERIORITY_OR_OTHER|||||||0.892||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.892
73941289|NCT00540124|147414471|SUPERIORITY_OR_OTHER|||||||0.593||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.593
73941290|NCT00540124|147414471|SUPERIORITY_OR_OTHER|||||||0.887||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.887
73941291|NCT00540124|147414471|SUPERIORITY_OR_OTHER|||||||0.762||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.762
73941292|NCT00540124|147414472|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.691
73941293|NCT00540124|147414472|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.415
73941294|NCT00540124|147414473|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.176
73974510|NCT00115934|147493902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||95.0|||||t-test, 2 sided|||||||0.97
73941295|NCT00540124|147414473|SUPERIORITY_OR_OTHER|||||||0.921||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.921
73941296|NCT00540124|147414474|SUPERIORITY_OR_OTHER|||||||0.429||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.429
73941297|NCT00540124|147414474|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.304
73941298|NCT00540124|147414475|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.254
73941299|NCT00540124|147414475|SUPERIORITY_OR_OTHER|||||||0.359||95.0||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.359
73941300|NCT00540124|147414475|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.098
73941301|NCT00540124|147414475|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.632
73941302|NCT00540124|147414475|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.102
73941303|NCT00540124|147414475|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.348
73941304|NCT00540124|147414476|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.208
73941305|NCT00540124|147414476|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.985
73941306|NCT00540124|147414477|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.385
73941307|NCT00540124|147414477|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.595
73941308|NCT00540124|147414477|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.704
73941309|NCT00540124|147414477|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.439
73941310|NCT00540124|147414478|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.838
73941311|NCT00540124|147414478|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.831
73941312|NCT00540124|147414478|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.696
73941313|NCT00540124|147414478|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.257
73941314|NCT00540124|147414479|SUPERIORITY_OR_OTHER|||||||0.709||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.709
73941315|NCT00540124|147414479|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.494
73974511|NCT00115934|147493903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54||95.0|||||t-test, 2 sided|||||||0.54
73974512|NCT00115934|147493904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73974513|NCT00115934|147493905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||Poisson regression|The offset parameter used in the poisson regression was the log of the number of patients in each treatment arm.||||||0.003
73974514|NCT00115934|147493906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.20
73974515|NCT00115934|147493907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.002
73974516|NCT00115934|147493908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Poisson regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.03
73974517|NCT03867201|147493923|SUPERIORITY||Mean Difference (Net)|-1.57|STANDARD_ERROR_OF_MEAN|0.64||0.015|TWO_SIDED|95.0|-2.83|-0.3|||Mixed Models Analysis|||||-0.30|-2.83|0.015
73974518|NCT04039113|147493930|SUPERIORITY||Rate Ratio|0.83||||0.1042|TWO_SIDED|90.0|0.64|1.06||1-sided p-value|Negative Binomial|||||1.06|0.64|0.1042
73867715|NCT02870101|147280819|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|83.0|||||TWO_SIDED|95.0|77.6|87.3|||||PPA estimated with two-sided 95% score confidence interval.|||87.3|77.6|
73867716|NCT02870101|147280819|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.1|||||TWO_SIDED|95.0|98.6|99.4|||||NPA estimated with two-sided 95% score confidence interval.|||99.4|98.6|
73974519|NCT04039113|147493930|SUPERIORITY||Rate Ratio|0.83||||0.2085|TWO_SIDED|95.0|0.61|1.11||2-sided p-value|Negative Binomial|||||1.11|0.61|0.2085
73974520|NCT00353496|147493942|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||<|0.001|TWO_SIDED|95.0|0.3|0.73||No p-value adjustment for multiple comparisons.|Log Rank|The log rank test was stratified according to progression status at baseline and prior therapy.||||0.73|0.30|<0.001
73867717|NCT01059994|147280827|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
73867718|NCT01059994|147280828|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
73974521|NCT00312208|147493958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.978||95.0|0.86|1.16||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates.|Log Rank|||||1.16|0.86|0.978
73974522|NCT00312208|147493959|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.371||95.0|0.75|1.11||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates.|Log Rank|||||1.11|0.75|0.371
73867719|NCT00820222|147280838|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.36|TWO_SIDED|95.0|0.26|1.63|||Odds Ratio||The Odds Ratio is based on a logistic regression model. The P-value for the test of Odds Ratio is 1.|||1.63|0.26|0.360
73974523|NCT03885232|147493973|SUPERIORITY|We applied a mixed zero-inflated beta regression model that included a fixed binary factor for treatment arm, a random effect for clinic to account for correlation within clinics, and unbalanced parent demographics across study arms.|Incidence Rate Ratio (IRR)|1.04||||0.9|TWO_SIDED|95.0|0.68|1.6|||Generalized linear mixed effects regress|Generalized linear mixed effects regression models||||1.60|0.68|0.9
73974524|NCT03885232|147493974|SUPERIORITY||Other|1.0|||<|0.05|TWO_SIDED||||||Chi-squared|||Calculated individual survey means for vaccine hesitant parents who participated in the survey. Survey consisted of 15 questions with a 7-point Likert scale. We then created a dichotomous variable where 1 = mean \> or equal to 6; 0 = mean \< 6.||||<0.05
73974525|NCT03885232|147493975|SUPERIORITY||Odds Ratio (OR)|1.92|||<|0.05|TWO_SIDED|95.0|0.66|5.64|||Generalized linear mixed effects regress|Adjusted for: study arm, study period (pre vs. post), years in practice, provider type, interaction between study arm and study period||"1. Ho: No difference in the proportion of clinicians using presumptive and Motivational Interviewing techniques between intervention and control.~2. Ho: No difference in the proportion of clinicians time spent talking to vaccine hesitant parents between intervention and control."||5.64|0.66|<0.05
73974526|NCT04612244|147493977|NON_INFERIORITY|"PT will be deemed to be non-inferior to PC if it can be established that the posterior probability Pr(HA \| data) \> Ψeff, where Ψeff is a pre-specified threshold value that controls the one-sided type I error rate (under simulation) at level 0.05. In the absence of missing data, the posterior distributions for PT and PC would be conjugate Beta distributions."||||||0.05|||||||t-test, 1 sided|||"The primary effectiveness endpoint for this study is Treatment Success, which will be analyzed as a test of non-inferiority of the event rate at 12 months using a noninferiority margin of 15%.~The null and alternative hypotheses are:~H0: PT ≤ PC - 0.15 versus HA: PT \> PC - 0.15 where PT is the Treatment Success rate at 12 months in the Pulsed Field Group and PC is the Treatment Success rate at 12 months in the Thermal (Control) Group."||||0.05
73974527|NCT04612244|147493979|SUPERIORITY|"The null and alternative hypotheses are provided below. H0: PT ≤ PC versus HA: PT \> PC where PT is the Treatment Success rate at 12 months in the Pulsed Field Group, and PC is the Treatment Success rate at 12 months in the Thermal Group.~Modeling will be identical primary endpoint and superiority concluded if the posterior probability Pr(HA \| data) \> Ψeff, sup, where the threshold Ψeff,sup is a pre-specified threshold value that controls the one-sided type I error rate at level 0.025."|Median Difference (Final Values)|0.708||||0.025|ONE_SIDED|97.5|||||t-test, 1 sided|||The secondary effectiveness endpoint for the ADVENT Trial is Treatment Superiority uses the same definition as the primary effectiveness endpoint for Treatment Success, but the test is for superiority between MITT subjects in the PFA and Thermal Groups.||||0.025
73974528|NCT03260569|147493982|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73974529|NCT06688357|147494013|SUPERIORITY||Cohen's d|0.99||||0.077|TWO_SIDED|||||t (13) = 1.920. Only 1 comparison with 2 means, thus no adjustment necessary|t-test, 2 sided|||Independent sample t-test conducted to examine difference in pre-post intervention change scores for the active vs sham intervention groups. Cohen's d was calculated to determine effect size.||||.077
73867720|NCT00820222|147280839|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.021|TWO_SIDED|95.0|1.04|1.64|||Log Rank||A HR \> 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.|||1.64|1.04|0.021
73867721|NCT00820222|147280841|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.095|TWO_SIDED|95.0|0.95|1.9|||Log Rank||A HR \> 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.|||1.90|0.95|0.095
73867722|NCT00820222|147280842|SUPERIORITY||Odds Ratio (OR)|0.7984||||0.2731|TWO_SIDED|95.0|0.5407|1.1771|||Fisher Exact|||Comparison for Overall Response (CR+PR)||1.1771|0.5407|0.2731
73867723|NCT00820222|147280843|SUPERIORITY||Odds Ratio (OR)|0.9016||||0.6106|TWO_SIDED|95.0|0.6315|1.2866|||Fisher Exact|||Comparison for Clinical Benefit||1.2866|0.6315|0.6106
73974530|NCT06688357|147494014|SUPERIORITY||Cohen's D|0.779||||0.159|TWO_SIDED|||||t(13) = 1.504; only 1 comparison of 2 values, thus no adjustment is necessary|t-test, 2 sided|||independent sample t-test; Cohen's d effect size||||.159
73867724|NCT01336023|147280858|NON_INFERIORITY|"Non-inferiority of IDegLira vs. IDeg was confirmed when 95% confidence interval for the treatment differences for change in HbA1c lies entirely below 0.3%.~IDegLira minus IDeg"|Treatment Contrast|-0.47|||||TWO_SIDED|95.0|-0.58|-0.36|||ANCOVA||IDegLira minus IDeg|||-0.36|-0.58|
73867725|NCT01336023|147280858|SUPERIORITY|"Superiority of IDegLira over liraglutide was confirmed when the 95% confidence interval for the treatment difference for change in HbA1c lies entirely below 0%.~IDegLira minus Liraglutide"|Treatment contrast|-0.64|||||TWO_SIDED|95.0|-0.75|-0.53|||ANCOVA||IDegLira minus Liraglutide|||-0.53|-0.75|
73867726|NCT04569357|147280873|SUPERIORITY|||||||0.0199|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 25%.||||0.0199
73974531|NCT06688357|147494015|SUPERIORITY||Cohen's D|0.356||||0.503|TWO_SIDED|||||t (13) = 0.688; only 1 comparison, adjustment not necessary|t-test, 2 sided|df = 13||independent samples t-test, cohen's d effect size||||.503
73974532|NCT06688357|147494016|SUPERIORITY||Cohen's D|-0.922||||0.08|TWO_SIDED|||||t(13) = 1.893; only one comparison of 2 scores, thus no adjustment for multiple comparisons was necessary|t-test, 2 sided|df = 13||Independent sample t-test used to examine pre-post intervention change scores in active vs sham groups; Cohen's d was calculated to estimate effect size||||0.08
73974533|NCT06688357|147494017|SUPERIORITY||Cohen's D|0.793||||0.149|TWO_SIDED|||||t (13) = 1.533; only 1 comparison, no adjustment necessary|t-test, 2 sided|||independent sample t-test, Cohen d effect size||||.149
74089126|NCT03575871|147731436|SUPERIORITY||Difference in LS mean|-32.9|||<|0.0001|TWO_SIDED|95.0|-44.6|-21.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-21.2|-44.6|<0.0001
73867727|NCT04569357|147280874|SUPERIORITY|||||||0.0096|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores after 8 weeks of treatment were compared.||||0.0096
73867728|NCT04569357|147280875|SUPERIORITY|||||||0.0063|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores (attention deficit subscale) after 8 weeks of treatment were compared.||||0.0063
73867729|NCT04569357|147280876|SUPERIORITY|||||||0.0525|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores (hyperactivity/impulsivity subscale) after 8 weeks of treatment were compared.||||0.0525
73941316|NCT00452387|147414494|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Fisher Exact|||The test of association of PSA and imaging response tests the null hypothesis that the proportion of cases exhibiting PSA response is the same for patients with and without a favorable imaging response. A 2x2 table was constructed based on the number of the patients in imaging response (favorable and unfavorable) and PSA response (\>50% reduction and \<=50% reduction). The Fisher's exact test was used to test this hypothesis.||||0.55
73941317|NCT00579280|147414502|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
73941318|NCT00579280|147414503|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73941319|NCT00579280|147414504|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
73941320|NCT00579280|147414505|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<.05
73941321|NCT00579280|147414506|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
73941322|NCT00579280|147414507|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
73941323|NCT00579280|147414508|SUPERIORITY||||||<|0.05|||||||Chi-squared|Differences in response (70% or greater improvement) and remission (50% or greater improvement) rates between the groups.||||||<0.05
73941324|NCT00579280|147414509|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
73941325|NCT00579280|147414510|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
73941326|NCT00579280|147414511|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
73941327|NCT00579280|147414512|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
73867730|NCT04569357|147280877|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect analysis.||||0.0024
73867731|NCT04569357|147280877|SUPERIORITY|||||||0.1722|||||||Wilcoxon (Mann-Whitney)|||Side effects analysis.||||0.1722
73941328|NCT01693068|147414513|OTHER|A log-rank test stratified by baseline Eastern Cooperative Oncology Group performance status (ECOG PS) (using the interactive voice response system \[IVRS\] value) will tested the null hypothesis of no difference between the Pimasertib (first line) and the Dacarbazine treatment groups at the 5% level.|Hazard Ratio (HR)|0.59||||0.0022|TWO_SIDED|95.0|0.42|0.83|||Stratified Log Rank Test||The Hazard Ratio is obtained from the Cox Proportional Hazards model based on dacarbazine and pimasertib only stratified by baseline ECOG Performance Status.|||0.83|0.42|0.0022
73941329|NCT02510144|147414524|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Negative cultures were compared on the treated side vs the non-treated side||||0.68
73941330|NCT02510144|147414524|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Negative cultures were compared on the treated side versus the non-treated side||||<0.01
73941331|NCT01239030|147414546|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046|||||||ANCOVA|||||||0.0046
73941332|NCT00182754|147414563|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
73941333|NCT02085252|147414570|SUPERIORITY_OR_OTHER|||||||0.0318||||||A 2-sided significance level of 5% was used. There was no adjustment for multiple comparisons.|Chi-squared|||The null hypothesis was that there was no difference between the two treatment strategies.||||0.0318
73941334|NCT02460692|147414596|SUPERIORITY|||||||0.78||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||This is the primary comparison.||||0.78
73941335|NCT02460692|147414596|SUPERIORITY|||||||0.07||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||This is the secondary comparison.||||0.070
73941336|NCT02460692|147414596|SUPERIORITY|||||||0.044||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||This is an exploratory comparison||||0.044
73941337|NCT02460692|147414597|SUPERIORITY|||||||0.27||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.27
73941338|NCT02460692|147414597|SUPERIORITY|||||||0.96||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.96
73941339|NCT02460692|147414597|SUPERIORITY|||||||0.3||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.30
73974534|NCT06688357|147494018|SUPERIORITY||Cohen's D|0.905||||0.104|TWO_SIDED|||||t(13) = 1.749; only 1 comparison with 2 values, thus no adjustment for multiple comparisons|t-test, 2 sided|df = 13||independent sample t-test was used to examine difference in Post-Pre intervention change in the Active vs the Sham groups; Effect size was estimated using Cohen's d.||||.104
73974535|NCT06688357|147494019|SUPERIORITY||Cohen's D|-0.267||||0.614|TWO_SIDED|||||t(13) = -.516; only 1 comparison of 2 means, no adjustment needed|t-test, 2 sided|||independent sample t-tests examining Post-Baseline differences for the Active vs the Sham groups; Effect size computed using Cohen's d score||||.614
73974536|NCT06688357|147494020|SUPERIORITY||Cohen's D|0.652||||0.23|TWO_SIDED|||||t(13) = -1.260; only 1 comparison of 2 values, no need for adjustment|t-test, 2 sided|||independent samples t-test, effect size computation (cohen's d)||||.230
73974537|NCT02879318|147494025|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.72|TWO_SIDED|90.0|0.71|1.25||a priori threshold for statistical significance was 0.1.|Log Rank|stratified by ECOG performance status and prior adjuvant therapy.||||1.25|0.71|0.72
73974538|NCT02879318|147494026|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.91|TWO_SIDED|90.0|0.75|1.29|||Log Rank|||||1.29|0.75|0.91
73974539|NCT02879318|147494027|SUPERIORITY||Odds Ratio (OR)|1.49||||0.28|TWO_SIDED|90.0|0.81|2.72|||Cochran-Mantel-Haenszel|stratified by ECOG performance status and prior adjuvant chemotherapy||||2.72|0.81|0.28
73974540|NCT01084863|147494028|EQUIVALENCE|Pharmacokinetic equivalence was predefined based on acceptance criteria, 80% to 125%.|Geometric Mean Ratio|104.57|||||TWO_SIDED|90.0|93.64|116.78||||||||116.78|93.64|
73974541|NCT03275285|147494044|SUPERIORITY|For PFS, the nominal significance levels at primary analysis was determined using alpha-spending function in order to control overall 1-sided type 1 error at 2.5%. The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis (103 PFS events) was 0.005. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.|Hazard Ratio (HR)|0.531||||0.0007|TWO_SIDED|99.0|0.318|0.889||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.005.|Stratified Log-Rank test|Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.|Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|Statistical analysis for comparison of PFS between the Kd and IKd arms based on primary analysis.||0.889|0.318|0.0007
73974542|NCT03275285|147494045|SUPERIORITY|The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis was 0.004. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.|Hazard Ratio (HR)|0.548||||0.0016|TWO_SIDED|99.2|0.317|0.948||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.004.|Stratified Log-Rank test|Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.|Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|Statistical analysis for comparison of PFS between the Kd and IKd arm based on primary analysis.||0.948|0.317|0.0016
73974543|NCT03275285|147494046|SUPERIORITY||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.4|0.418|0.792|||||Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.792|0.418|
73974544|NCT03275285|147494047|SUPERIORITY||Hazard Ratio (HR)|0.594|||||TWO_SIDED|95.4|0.424|0.832|||||Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.832|0.424|
73974545|NCT03275285|147494048|SUPERIORITY|A closed test procedure was used to control the Type I error rate from the primary efficacy endpoints sequentially through the secondary efficacy endpoints. No further testing would be performed unless the significance level had been reached on PFS and testing on subsequent endpoints were continued only if the null hypothesis for the previously tested endpoint was rejected.||||||0.193||||||One-sided p-value based on Stratified Cochran-Mantel-Haenszel test. Threshold for statistical significance level at 0.025.|Cochran-Mantel-Haenszel|One sided p-value was stratified based on randomization factors according to IRT.||Statistical analysis for comparison of Overall Response between the Kd and IKd arms based on primary analysis.||||0.1930
73974546|NCT03275285|147494055|SUPERIORITY||Stratified Hazard Ratio|0.425|||||TWO_SIDED|95.0|0.269|0.672|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.672|0.269|
73974547|NCT03275285|147494056|SUPERIORITY||Stratified Hazard Ratio|0.495|||||TWO_SIDED|95.0|0.324|0.757|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.757|0.324|
73974548|NCT03275285|147494057|SUPERIORITY||Stratified Hazard Ratio|1.143|||||TWO_SIDED|95.0|0.888|1.471|||||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|1.471|0.888|
73974549|NCT03275285|147494058|SUPERIORITY||Stratified Hazard Ratio|0.955|||||TWO_SIDED|95.0|0.74|1.233|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||1.233|0.740|
73974550|NCT03275285|147494059|SUPERIORITY|\[Not specified\]|[Stratified Hazard Ratio]|0.683|||||TWO_SIDED|95.0|0.496|0.941|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|\[Not specified\]||0.941|0.496|
74031183|NCT05070429|147615894|SUPERIORITY||Maximum likelihood (MLE)|-0.011||||0.87|TWO_SIDED|95.0|-0.147|0.125|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare treatment satisfaction at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||0.125|-0.147|0.87
74089127|NCT03575871|147731436|SUPERIORITY||Difference in LS mean|-40.6|||<|0.0001|TWO_SIDED|95.0|-52.2|-28.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-28.9|-52.2|<0.0001
74089128|NCT03575871|147731436|SUPERIORITY||Difference in LS mean|-39.6|||<|0.0001|TWO_SIDED|95.0|-51.8|-27.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-27.4|-51.8|<0.0001
73974551|NCT03275285|147494060|SUPERIORITY|\[Not specified\]|Stratified Hazard Ratio|0.663|||||TWO_SIDED|95.0|0.491|0.895|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|\[Not specified\]||0.895|0.491|
73974552|NCT03400150|147494112|OTHER|||||||0.025|TWO_SIDED|95.0|||||Farrington-Manning|||||||0.025
73974553|NCT05501600|147494137|SUPERIORITY|||||||0.004|||||||Regression, Linear|||||||0.004
73974554|NCT05501600|147494138|SUPERIORITY|||||||0.081616|||||||t-test, 2 sided|||||||0.081616
73974555|NCT00220805|147494212|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|95.0|||||ANOVA|||The primary efficacy comparison for the change in LogMAR from baseline to endpoint was a two-way analysis of variance (ANOVA) with treatment group and center as fixed factors (main effect model).||||0.49
73974556|NCT00220805|147494213|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|||||Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)|Cochran-Mantel-Haenszel|||||||0.76
73974557|NCT00220805|147494214|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Cochran-Mantel-Haenszel|Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)||||||0.13
73974558|NCT00220805|147494215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9|TWO_SIDED|95.0|-0.21|0.19|||ANOVA|||||0.19|-0.21|0.90
73974559|NCT00220805|147494217|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Cochran-Mantel-Haenszel|Adjusted to centers||||||0.74
73974560|NCT04327843|147494225|OTHER|This is a prospective study with a repeated measures design.||||||0.001||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed||||||0.001
73974561|NCT04327843|147494226|OTHER|This is a prospective study with a repeated measures design.||||||0.43||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.43
73974562|NCT04327843|147494227|OTHER|This is a prospective study with a repeated measures design.||||||0.07||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.07
74031184|NCT05070429|147615895|SUPERIORITY||Maximum likelihood (MLE)|0.059||||0.66|TWO_SIDED|95.0|-0.201|0.32|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare primary COSI goal achievement at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||0.320|-0.201|0.66
73974563|NCT04327843|147494228|OTHER|This is a prospective study with a repeated measures design.||||||0.1||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.10
73974564|NCT04327843|147494229|OTHER|This is a prospective study with a repeated measures design.||||||0.75||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.75
73974565|NCT04327843|147494230|OTHER|This is a prospective study with a repeated measures design.||||||1||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||1.00
73974566|NCT04327843|147494232|OTHER|This is a prospective study with a repeated measures design.||||||0.75||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.75
73974567|NCT04327843|147494233|OTHER|This is a prospective study with a repeated measures design.||||||0.14||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.14
73974568|NCT05274321|147494234|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.22||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.22
73974569|NCT05274321|147494235|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval. .||||||0.02||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.02
73974570|NCT05274321|147494236|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.03||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.03
73974571|NCT05274321|147494237|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.25||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.25
73974572|NCT01105975|147494238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.5|||<|0.001|TWO_SIDED|90.0|64.9|92.1|||mixed model repeated measures (MMRM)|||||92.1|64.9|<0.001
73941340|NCT02460692|147414598|SUPERIORITY|||||||0.44||||||The average NPS change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.44
73941341|NCT02460692|147414598|SUPERIORITY|||||||0.53||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|Unstructured covariance model|||||||0.53
73941342|NCT02460692|147414598|SUPERIORITY|||||||0.18||||||The average NPS change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|Unstructured covariance model|||||||0.18
73941343|NCT02460692|147414599|SUPERIORITY|||||||0.95||||||The average change of learning scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.95
73941344|NCT02460692|147414599|SUPERIORITY|||||||0.94||||||The average change of learning scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.94
73941345|NCT02460692|147414599|SUPERIORITY|||||||0.9||||||The average change of learning score at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||.90
73941346|NCT02460692|147414600|SUPERIORITY|||||||0.93||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8 at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.93
73941347|NCT02460692|147414600|SUPERIORITY|||||||0.92||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.92
73974573|NCT01105975|147494239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9||||0.002|TWO_SIDED|90.0|-21.2|-6.7|||mixed model repeated measures (MMRM)|||||-6.7|-21.2|0.002
73941348|NCT02460692|147414600|SUPERIORITY|||||||0.85||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.85
73941349|NCT02460692|147414601|SUPERIORITY|||||||0.89||||||The average change in Wechsler Adult Intelligence Scale (WAIS)-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model.|Unstructured covariance model|||||||0.89
73941350|NCT02460692|147414601|SUPERIORITY|||||||0.13||||||The average change in WAIS-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.13
73941351|NCT02460692|147414601|SUPERIORITY|||||||0.14||||||The average change in WAIS-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.14
73941352|NCT02460692|147414602|SUPERIORITY|||||||0.1||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||||||0.10
73941353|NCT02460692|147414602|SUPERIORITY|||||||0.67||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.67
73941354|NCT02460692|147414602|SUPERIORITY|||||||0.25||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.25
73941355|NCT02460692|147414603|SUPERIORITY|||||||0.84||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.84
73941356|NCT02460692|147414603|SUPERIORITY|||||||0.91||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.91
73941357|NCT02460692|147414603|SUPERIORITY|||||||0.75||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.75
73941358|NCT02460692|147414604|SUPERIORITY|||||||0.24||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.24
73941359|NCT02460692|147414604|SUPERIORITY|||||||0.08||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.080
73941360|NCT02460692|147414604|SUPERIORITY|||||||0.005||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.005
73941361|NCT02460692|147414605|SUPERIORITY|||||||0.6|||||||unstructured covariance model|||||||0.60
73941362|NCT02460692|147414605|SUPERIORITY|||||||0.4|||||||unstructured covariance model|||||||0.40
73941363|NCT02460692|147414605|SUPERIORITY|||||||0.72|||||||unstructured covariance model|||||||0.72
73941364|NCT02460692|147414606|SUPERIORITY|||||||0.19||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.19
73941365|NCT02460692|147414606|SUPERIORITY|||||||0.7||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.70
73974574|NCT01105975|147494240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|56.7|||<|0.001|TWO_SIDED|90.0|43.6|69.8|||mixed model repeated measures (MMRM)|||||69.8|43.6|<0.001
73974575|NCT01105975|147494240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|97.6|||<|0.001||90.0|84.5|110.8|||mixed model repeated measures (MMRM)|||||110.8|84.5|<0.001
73867732|NCT04569357|147280877|SUPERIORITY|||||||0.0012|||||||Wilcoxon (Mann-Whitney)|||Efficacy index analysis.||||0.0012
73974576|NCT01105975|147494240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|131.9|||<|0.001|TWO_SIDED|90.0|118.5|145.2|||mixed model repeated measures (MMRM)|||||145.2|118.5|<0.001
73974577|NCT01105975|147494241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|90.0|-24.6|-10.5|||mixed model repeated measures (MMRM)|||||-10.5|-24.6|<0.001
73867733|NCT04569357|147280878|SUPERIORITY|||||||0.13||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.13
73941366|NCT02460692|147414606|SUPERIORITY|||||||0.36||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model|unstructured covariance model|||||||0.36
73867734|NCT04569357|147280879|SUPERIORITY|||||||0.81||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to Systolic pressure data.||||0.81
73941367|NCT02460692|147414607|SUPERIORITY|||||||0.14|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.14
73941368|NCT02460692|147414607|SUPERIORITY|||||||0.6|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.60
73941369|NCT02460692|147414607|SUPERIORITY|||||||0.34|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.34
73974578|NCT01105975|147494241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.2|||<|0.001|TWO_SIDED|90.0|-33.2|-19.2|||mixed model repeated measures (MMRM)|||||-19.2|-33.2|<0.001
73974579|NCT01105975|147494241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.8|||<|0.001|TWO_SIDED|90.0|-47.0|-32.7|||mixed model repeated measures (MMRM)|||||-32.7|-47.0|<0.001
73941370|NCT02460692|147414608|SUPERIORITY|||||||0.34|||||||unstructured covariance model|||||||0.34
73941371|NCT02460692|147414608|SUPERIORITY|||||||0.007|||||||unstructured covariance model|||||||0.007
73941372|NCT02460692|147414608|SUPERIORITY|||||||0.055|||||||unstructured covariance model|||||||0.055
73941373|NCT02460692|147414609|SUPERIORITY|||||||0.69|||||||unstructured covariance model|||||||0.69
73941374|NCT02460692|147414609|SUPERIORITY|||||||0.79|||||||unstructured covariance model|||||||0.79
73974580|NCT01105975|147494242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.3|||<|0.001||90.0|66.2|92.4|||mixed model repeated measures (MMRM)|||||92.4|66.2|<0.001
73941375|NCT02460692|147414609|SUPERIORITY|||||||0.97|||||||unstructured covariance model|||||||0.97
73941376|NCT02460692|147414610|SUPERIORITY|||||||0.21||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.21
73941377|NCT02460692|147414610|SUPERIORITY|||||||0.029||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.029
73941378|NCT02460692|147414610|SUPERIORITY|||||||0.001||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.001
73941379|NCT02460692|147414611|SUPERIORITY|||||||0.084|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.084
73941380|NCT02460692|147414611|SUPERIORITY|||||||0.98|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.98
73941381|NCT02460692|147414611|SUPERIORITY|||||||0.085|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.085
73941382|NCT02460692|147414612|SUPERIORITY|||||||0.95||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model|unstructured covariance model|||||||0.95
73941383|NCT02460692|147414612|SUPERIORITY|||||||0.78||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.78
73974581|NCT01105975|147494242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.5|||<|0.001|TWO_SIDED|90.0|75.2|101.8|||mixed model repeated measures (MMRM)|||||101.8|75.2|<0.001
73974582|NCT01105975|147494243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2||||0.009|TWO_SIDED|90.0|-18.3|-4.2|||mixed model repeated measures (MMRM)|||||-4.2|-18.3|0.009
73974583|NCT01105975|147494243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.5||||0.002|TWO_SIDED|90.0|-20.6|-6.4|||mixed model repeated measures (MMRM)|||||-6.4|-20.6|0.002
73974584|NCT01371994|147494288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1745|TWO_SIDED||||||Log Rank|Based on a Log-rank test stratified by (pooled) center and Baseline daily pad usage (≤ 3 and \> 3).||The treatment difference in the primary efficacy variable was tested using a log-rank test stratified by (pooled) center and by Baseline daily pad usage (≤3 and \>3) at a 2-sided significance level of 0.05.||||0.1745
73974585|NCT01371994|147494289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4833|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 4||||0.4833
73974586|NCT01371994|147494289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5761|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 8||||0.5761
73974587|NCT01371994|147494289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0592|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 12||||0.0592
73974588|NCT01371994|147494289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison of end of treatment analysis||||0.0390
73974589|NCT01371994|147494291|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.3604|TWO_SIDED|95.0|-0.14|0.38|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 4||0.38|-0.14|0.3604
73974590|NCT01371994|147494291|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.0761|TWO_SIDED|95.0|-0.03|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 8||0.52|-0.03|0.0761
73867735|NCT04569357|147280879|SUPERIORITY|||||||0.22||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to Diastolic pressure data.||||0.22
73941384|NCT02460692|147414612|SUPERIORITY|||||||0.99||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.99
73941385|NCT00541450|147414630|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.002
73941386|NCT00541450|147414631|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.001
73941387|NCT00541450|147414632|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.16||||||95.0|-0.37|0.05|||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||0.05|-0.37|
73974591|NCT01371994|147494291|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0149|TWO_SIDED|95.0|0.07|0.64|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 12||0.64|0.07|0.0149
73974592|NCT01371994|147494291|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0325|TWO_SIDED|95.0|0.02|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison of end of treatment analysis||0.52|0.02|0.0325
73974593|NCT01371994|147494293|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.46||0.5186|TWO_SIDED|95.0|-0.6|1.19|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||1.19|-0.60|0.5186
73974594|NCT01371994|147494293|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.43||0.4521|TWO_SIDED|95.0|-0.52|1.17|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||1.17|-0.52|0.4521
73974595|NCT01371994|147494295|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1493|TWO_SIDED|95.0|-0.07|0.47|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||0.47|-0.07|0.1493
73974596|NCT01371994|147494295|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1499|TWO_SIDED|95.0|-0.07|0.44|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||0.44|-0.07|0.1499
74039429|NCT04847141|147632420|SUPERIORITY||Difference in Percentage|0.01||||0.989|TWO_SIDED|95.0|-2.99|3.07||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required ICU admission between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||3.07|-2.99|0.9890
73867736|NCT04569357|147280880|SUPERIORITY|||||||0.13||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.13
73941388|NCT00541450|147414634|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.030
73941389|NCT00803452|147414646|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
73941390|NCT02291679|147414647|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.76|5.2||P-value is obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% confidence interval (CI) for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|||5.20|1.76|< 0.0001
73974597|NCT01371994|147494297|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1279|TWO_SIDED|95.0|-0.16|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||1.23|-0.16|0.1279
73974598|NCT01371994|147494297|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.6|STANDARD_ERROR_OF_MEAN|0.34||0.1038|TWO_SIDED|95.0|-0.11|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||1.23|-0.11|0.1038
73974599|NCT01371994|147494299|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.98||0.8876|TWO_SIDED|95.0|-4.19|3.63|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||3.63|-4.19|0.8876
73867737|NCT04569357|147280881|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.2
73867738|NCT04569357|147280882|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
73941391|NCT02291679|147414648|SUPERIORITY||LS Mean Difference|0.841|||<|0.0001|TWO_SIDED|95.0|0.505|1.176||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||1.176|0.505|< 0.0001
73941392|NCT02291679|147414649|SUPERIORITY||LS Mean Difference|1.037|||<|0.0001|TWO_SIDED|95.0|0.636|1.438||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||1.438|0.636|< 0.0001
73974600|NCT01371994|147494299|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.86||0.395|TWO_SIDED|95.0|-8.1|3.21|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||3.21|-8.10|0.3950
73974601|NCT01371994|147494301|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.0|STANDARD_ERROR_OF_MEAN|2.43||0.4126|TWO_SIDED|95.0|-2.82|6.81|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||6.81|-2.82|0.4126
73974602|NCT01371994|147494301|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.0|STANDARD_ERROR_OF_MEAN|2.47||0.6959|TWO_SIDED|95.0|-3.92|5.85|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||5.85|-3.92|0.6959
73974603|NCT01371994|147494303|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|3.3|STANDARD_ERROR_OF_MEAN|2.81||0.2402|TWO_SIDED|95.0|-2.26|8.91|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||8.91|-2.26|0.2402
73941393|NCT02291679|147414650|SUPERIORITY||LS Mean Difference|0.628|||<|0.0001|TWO_SIDED|95.0|0.45|0.806||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||0.806|0.450|< 0.0001
73974604|NCT01371994|147494303|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.1|STANDARD_ERROR_OF_MEAN|2.83||0.698|TWO_SIDED|95.0|-4.5|6.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||6.70|-4.50|0.6980
73974605|NCT01371994|147494305|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.0|STANDARD_ERROR_OF_MEAN|2.46||0.4067|TWO_SIDED|95.0|-2.8|6.89|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||6.89|-2.80|0.4067
73941394|NCT02291679|147414651|SUPERIORITY||LS Mean Difference|-0.329|||<|0.0001|TWO_SIDED|95.0|-0.449|-0.21||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||-0.210|-0.449|< 0.0001
73974606|NCT01371994|147494305|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|STANDARD_ERROR_OF_MEAN|2.36||0.8507|TWO_SIDED|95.0|-4.21|5.1|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||5.10|-4.21|0.8507
73974607|NCT01371994|147494306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|||||||Log Rank|Based on a Log-rank test stratified by (pooled) center.||||||0.2700
73974608|NCT03280030|147494308|OTHER|Success criteria is considered based on point estimated Hazard ratio|Hazard Ratio, log|1.326|||||TWO_SIDED|95.0|0.624|2.818||||||||2.818|0.624|
73974609|NCT03593356|147494321|SUPERIORITY||Slope|-0.427|STANDARD_ERROR_OF_MEAN|1.179||0.717|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.717
73974610|NCT03593356|147494324|SUPERIORITY||Slope|-0.012|STANDARD_ERROR_OF_MEAN|0.043||0.784|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.789.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.784
73974611|NCT03593356|147494325|SUPERIORITY||Slope|0.578|STANDARD_ERROR_OF_MEAN|0.807||0.474|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.474
73974612|NCT03593356|147494332|SUPERIORITY||Slope|0.234|STANDARD_ERROR_OF_MEAN|0.882||0.871|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.791.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.871
73974613|NCT03593356|147494333|SUPERIORITY||Slope|0.021|STANDARD_ERROR_OF_MEAN|0.046||0.871|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.646.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.871
73867739|NCT04569357|147280883|SUPERIORITY|||||||0.5|||||||Fisher Exact|||||||0.5
73974614|NCT03593356|147494334|SUPERIORITY||Slope|0.139|STANDARD_ERROR_OF_MEAN|0.86||0.872|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.872
73974615|NCT03593356|147494337|SUPERIORITY||Slope|0.133|STANDARD_ERROR_OF_MEAN|0.1||0.184|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.184
74008476|NCT00621751|147566627|OTHER|A prespecified secondary analysis compared proportions of participants that experienced a decrease of \> 1 MCID in the NPI-I/A Rasch construct score (i.e., participants that are considered to have meaningful reduction in irritability/aggression) from baseline to day-42 between the groups using a chi-square test. MCID was defined as 0.5 times the standard deviation of baseline scores.|||||<|0.05|||||||ANCOVA|||||||< .05
73867740|NCT04569357|147280884|SUPERIORITY|||||||0.0254|||||||Fisher Exact|||||||0.0254
73867741|NCT01853878|147280887|EQUIVALENCE|P-value of the Wald test from a Cox regression model to test H0 = { HR=1} (Y = Time to Event)|Hazard Ratio (HR)|4.592||||0.1422|TWO_SIDED|95.0|0.6|35.167|||Regression, Cox|||Estimates of Hazard Ratio (HR) and their 95% Confidence Interval (CI) were obtained by Cox regression modelling.The Likelihood ratio test was used to compare the groups. The Cox proportional hazard regression was stratified by previous treatment \[Chemotherapy (CT) vs. no-CT\] and disease stage.||35.167|0.600|0.1422
73941395|NCT02291679|147414652|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0008|TWO_SIDED|95.0|1.47|4.87||P-value is obtained from the CMH tests controlling for geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region.|||4.87|1.47|0.0008
73941396|NCT02291679|147414653|SUPERIORITY||Odds Ratio (OR)|2.58|||<|0.0001|TWO_SIDED|95.0|1.58|4.2||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||4.20|1.58|< 0.0001
73941397|NCT02291679|147414654|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0002|TWO_SIDED|95.0|1.42|3.26||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||3.26|1.42|0.0002
73941398|NCT02291679|147414655|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0342|TWO_SIDED|95.0|1.03|2.17||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||2.17|1.03|0.0342
73941399|NCT02291679|147414656|SUPERIORITY||LS Mean Difference|-0.319||||0.0063|TWO_SIDED|95.0|-0.548|-0.09||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||-0.090|-0.548|0.0063
73941400|NCT02291679|147414657|SUPERIORITY||LS Mean Difference|-0.178||||0.1028|TWO_SIDED|95.0|-0.391|0.036||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||0.036|-0.391|0.1028
73941401|NCT02291679|147414658|SUPERIORITY||Odds Ratio (OR)|2.78||||0.0001|TWO_SIDED|95.0|1.61|4.8||P-value is obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|||4.80|1.61|0.0001
73974616|NCT03593356|147494340|SUPERIORITY||Slope|0.138|STANDARD_ERROR_OF_MEAN|0.173||0.415|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.427.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.415
73974617|NCT03593356|147494341|SUPERIORITY||Slope|0.086|STANDARD_ERROR_OF_MEAN|0.14||0.567|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.541.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.567
73867742|NCT01399866|147280904|SUPERIORITY|||||||0.574|||||||ANOVA|||||||0.574
73941402|NCT04333420|147414684|SUPERIORITY||LS means difference|-16.4||||0.3677|TWO_SIDED|95.0|-53.2|20.3|||Linear repeated measures model|||||20.3|-53.2|0.3677
73941403|NCT04333420|147414685|SUPERIORITY||Hazard Ratio (HR)|0.728||||0.0941|TWO_SIDED|95.0|0.502|1.056|||Regression, Cox|including stratification by site||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by site; 61 patients from sites with no events (no death) or from single patient sites with death factually make no contribution to the analysis outcome.||1.056|0.502|0.0941
73941404|NCT04333420|147414685|SUPERIORITY||Hazard Ratio (HR)|0.674||||0.0266|TWO_SIDED|95.0|0.476|0.955|||Regression, Cox|Without stratification by site||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) without stratification by site; Post-hoc analysis||0.955|0.476|0.0266
73941405|NCT04333420|147414685|SUPERIORITY||Hazard Ratio (HR)|0.648||||0.0181|TWO_SIDED|95.0|0.453|0.929|||Regression, Cox|Including random effect for site (frailty model)||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including random effect for site (frailty model); Post-hoc analysis||0.929|0.453|0.0181
73941406|NCT04333420|147414685|SUPERIORITY||Hazard Ratio (HR)|0.613||||0.0067|TWO_SIDED|95.0|0.43|0.873|||Regression, Cox|Including stratification by country||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by country; Post-hoc analysis||0.873|0.430|0.0067
74008477|NCT00763971|147566649|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-18.6|||<|0.001|TWO_SIDED|95.0|-21.5|-15.7|||ANCOVA|||||-15.7|-21.5|<0.001
73867743|NCT01399866|147280904|SUPERIORITY|||||||0.747|||||||ANOVA|||||||0.747
73867744|NCT01399866|147280905|SUPERIORITY|||||||0.94|||||||ANOVA|||||||0.94
73867745|NCT01399866|147280906|SUPERIORITY|||||||0.818|||||||ANOVA|||||||0.818
73867746|NCT01399866|147280907|SUPERIORITY|||||||0.123|||||||ANOVA|||||||0.123
73867747|NCT01399866|147280908|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||||||0.473
73867748|NCT03916081|147280909|SUPERIORITY||LS Mean Difference vs Vehicle|-1.18||||0.356|TWO_SIDED|95.0|-2.983|0.619||MMRM = mixed effects model for repeated measures vIGA-AD = validated Investigator Global Assessment scale for Atopic Dermatitis|MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||0.619|-2.983|0.356
74089129|NCT03575871|147731436|SUPERIORITY||Difference in LS mean|-48.2|||<|0.0001|TWO_SIDED|95.0|-60.4|-36.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-36.0|-60.4|<0.0001
74089130|NCT03575871|147731437|SUPERIORITY||Difference in Percentage|1.9||||0.2353|TWO_SIDED|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-2.2|0.2353
74089131|NCT03575871|147731437|SUPERIORITY||Difference in Percentage|5.8||||0.0332|TWO_SIDED|95.0|0.8|10.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.8|0.8|0.0332
74008478|NCT00763971|147566649|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-13.0|||<|0.001|TWO_SIDED|95.0|-15.9|-10.2|||ANCOVA|||||-10.2|-15.9|<0.001
74008479|NCT00763971|147566650|SUPERIORITY_OR_OTHER_LEGACY||difference in percentages|63.6|||<|0.001|TWO_SIDED|95.0|53.0|74.1|||Cochran-Mantel-Haenszel|||||74.1|53.0|<0.001
74008480|NCT00763971|147566650|SUPERIORITY_OR_OTHER_LEGACY||difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|34.6|57.7|||Cochran-Mantel-Haenszel|||||57.7|34.6|<0.001
74008481|NCT00763971|147566651|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-21.3|||<|0.001|TWO_SIDED|95.0|-25.5|-17.0|||ANCOVA|||||-17.0|-25.5|<0.001
74008482|NCT00763971|147566651|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-15.1|||<|0.001|TWO_SIDED|95.0|-19.3|-10.9|||ANCOVA|||||-10.9|-19.3|<0.001
74008483|NCT00763971|147566653|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|8.8|||<|0.001|TWO_SIDED|95.0|6.1|11.5|||ANCOVA|||||11.5|6.1|<0.001
74008484|NCT00763971|147566653|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|7.3|||<|0.001|TWO_SIDED|95.0|4.6|10.0|||ANCOVA|||||10.0|4.6|<0.001
74008485|NCT00763971|147566654|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.2|||ANCOVA|||||-0.2|-0.4|<0.001
74008486|NCT00763971|147566654|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||||-0.1|-0.3|<0.001
74008487|NCT01809132|147566663|SUPERIORITY|||||||0.3|||||||Log Rank|||||||.30
74008488|NCT01809132|147566664|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||the observational subject was lost to follow-up||||.42
74008489|NCT01809132|147566665|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||.75
74008490|NCT01809132|147566666|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||.17
74008491|NCT03349775|147566667|SUPERIORITY||Median Difference (Final Values)|-2.57|STANDARD_DEVIATION|5.14||0.35|TWO_SIDED|95.0|-8.32|3.18|||t-test, 2 sided|||||3.18|-8.32|0.35
74008492|NCT03349775|147566668|SUPERIORITY||Median Difference (Final Values)|1.13|STANDARD_DEVIATION|2.13||0.37|TWO_SIDED|95.0|-1.65|3.92|||t-test, 2 sided|||||3.92|-1.65|0.37
74008493|NCT01516970|147566670|SUPERIORITY_OR_OTHER|||||||0.2434||||||The discontinuation rates were compared with a statistical test (Cochran-Mantel-Haenszel \[CMH\]-Test) with p-value: 0.2434|Cochran-Mantel-Haenszel|||||||0.2434
74008494|NCT01516970|147566671|SUPERIORITY_OR_OTHER|||||||0.8839||||||The percentage of participants with TEAEs were compared with a statistical test (Fisher's Exact Test) with p-value: 0.8839.|Fisher Exact|||||||0.8839
74008495|NCT01756040|147566675|OTHER|||||||0.932||||||not adjusted for multiple comparisons. The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||We hypothesized that intestinal permeability as measured by urinary lactulose/rhamnose ratio would be higher in the lower gestational age (\<29 weeks) compared to the more mature infants (≥29 weeks gestation) at postnatal age 7-10 days.||||0.932
74008496|NCT01756040|147566676|OTHER|||||||0.316|||||||t-test, 2 sided|||We hypothesized that stool A1AT would be higher in infants with high IP as measured by urinary La/Rh compared to those with low IP.||||0.316
74008497|NCT01756040|147566677|OTHER|||||||0.011||||||The significance value was estimated using Bayesian goodness-of-fit p-value to assess the significance of the association of the relative abundance of Clostridiales and IP categories. P value \<0.05 was considered significant.|Bayesian goodness of fit|||||||0.011
74008498|NCT01756040|147566678|OTHER|||||||0.0023|||||||t-test, 2 sided|||We hypothesized that infants with normal barrier function (La/Rh ratio ≤0.05) would have been fed breastmilk for longer duration than infants with impaired barrier function (La/Rh\>0.05).||||0.0023
74008499|NCT01756040|147566679|OTHER|||||||1|||||||Chi-squared|||||||1.0
74008500|NCT01756040|147566680|OTHER|||||||0.461||||||A priori threshold \<0.05|Chi-squared|||||||0.461
74008501|NCT01756040|147566681|OTHER|||||||0.019|||||||t-test, 2 sided|||We hypothesized that infants with impaired barrier function as measured by high urinary La/Rh (\>0.05) ratio at 7-10 days of age would require longer time to reach full enteral feedings than infants with normal barrier function (La/Rh≤0.05)||||0.019
74008502|NCT03334409|147566743|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74008503|NCT03334409|147566744|SUPERIORITY|||||||0.08|||||||Log Rank|||||||0.08
74008504|NCT03334409|147566745|SUPERIORITY|||||||0.08|||||||Log Rank|||||||0.08
74008505|NCT03334409|147566746|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
74008506|NCT03334409|147566747|SUPERIORITY|||||||0.18|||||||Kruskal-Wallis|||||||0.18
74008507|NCT03334409|147566748|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
74008508|NCT05395104|147566787|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.0865|||||TWO_SIDED|90.0|0.9724|1.2141||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2141|0.9724|
73974618|NCT03211247|147494568|OTHER||Proportion difference|33.4|||<|0.001|TWO_SIDED|95.0|22.36|44.49|||Wald test||The 2-sided Farrington-Manning 95% confidence interval for the difference in response rates was calculated.|Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Farrington-Manning 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Farrignton-Manning 95% CI of the difference in response rates ≥15%.||44.49|22.36|<0.001
73974619|NCT01983683|147494606|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-4.7|||||TWO_SIDED|95.0|-10.7|1.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|||1.3|-10.7|
73974620|NCT01983683|147494606|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-3.6|||||TWO_SIDED|95.0|-9.6|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT||2.3|-9.6|
73974621|NCT01983683|147494607|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-4.9|||||TWO_SIDED|95.0|-10.4|0.6|||||CI for the difference between two proportions are estimated using the Wilson' score method|||0.6|-10.4|
73974622|NCT01983683|147494608|SUPERIORITY|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|1.7|||||TWO_SIDED|95.0|-6.1|9.4|||||CI for the difference between two proportions are estimated using the Wilson's score method|||9.4|-6.1|
73974623|NCT01983683|147494609|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7794|TWO_SIDED|95.0|0.86|1.24||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank|||||1.24|0.86|0.7794
73974624|NCT01983683|147494610|SUPERIORITY||Least Square Mean difference|-0.044||||0.6871|TWO_SIDED|95.0|-0.26|0.17||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores||0.17|-0.26|0.6871
73974625|NCT01983683|147494610|SUPERIORITY||Least Square Mean difference|0.025||||0.7833|TWO_SIDED|95.0|-0.15|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores||0.20|-0.15|0.7833
73974626|NCT01983683|147494610|SUPERIORITY||Least Square Mean difference|0.061||||0.4145|TWO_SIDED|95.0|-0.09|0.21||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the other symptoms domain scores||0.21|-0.09|0.4145
73974627|NCT01983683|147494611|OTHER||Difference between 2 proportions|-1.1|||||TWO_SIDED|95.0|-6.5|4.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||4.2|-6.5|
73974628|NCT01983683|147494612|OTHER||Difference between 2 proportions|-1.6|||||TWO_SIDED|95.0|-6.5|3.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||3.3|-6.5|
73974629|NCT01983683|147494613|OTHER||Difference between 2 proportions|8.8|||||TWO_SIDED|95.0|1.1|16.4|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||16.4|1.1|
73974630|NCT01983683|147494614|SUPERIORITY|Sensitivity analysis|Difference between 2 proportions|2.7|||||TWO_SIDED|95.0|-5.5|10.9|||||CI for the difference between two proportions are estimated using the Wilson's score method|||10.9|-5.5|
73974631|NCT02549352|147494638|SUPERIORITY||Ratio of clearance rates|7.83|||<|0.001|TWO_SIDED|95.0|2.58|23.71|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|||23.71|2.58|<0.001
73974632|NCT02549352|147494639|SUPERIORITY||Ratio of clearance rates|5.91|||<|0.001|TWO_SIDED|95.0|3.32|10.51|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.51|3.32|<0.001
73974633|NCT02549352|147494640|SUPERIORITY||Ratio of clearance rates|7.59|||<|0.001|TWO_SIDED|95.0|3.7|15.61|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||15.61|3.70|<0.001
73974634|NCT02549352|147494641|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.36||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.36|0.25|<0.001
74008509|NCT05395104|147566789|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.1174|||||TWO_SIDED|90.0|0.9784|1.2762||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2762|0.9784|
73867749|NCT03916081|147280909|SUPERIORITY||LS Mean Difference vs Vehicle|-1.6||||0.097|TWO_SIDED|95.0|-3.382|0.178|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||0.178|-3.382|0.097
73867750|NCT03916081|147280910|SUPERIORITY||LS Mean Difference|-11.37||||0.248|TWO_SIDED|95.0|-26.789|4.044|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||4.044|-26.789|0.248
73867751|NCT03916081|147280910|SUPERIORITY||LS Mean Difference|-10.28||||0.349|TWO_SIDED|95.0|-25.666|5.114|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||5.114|-25.666|0.349
73941407|NCT04333420|147414685|SUPERIORITY||Risk Difference (RD)|-11.0||||0.0293|TWO_SIDED|95.0|-20.8|-1.2|||Regression, Logistic|Multiple imputation of missing values|Risk difference and lower/upper limit of the Confidence Interval are given in percent|Sensitivity analysis; 369 patients were included in this analysis including the patient that was randomized in error and not treated. Missing values were imputed by multiple imputation.||-1.2|-20.8|0.0293
73941408|NCT04333420|147414685|SUPERIORITY|||||||0.0407|||||||Log Rank|||Post-hoc analysis||||0.0407
73941409|NCT04333420|147414686|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.6494|TWO_SIDED|95.0|0.103|4.135|||Regression, Cox|Covariate: Treatment (IFX-1 + BSC)||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death)||4.135|0.103|0.6494
73941410|NCT04333420|147414690|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0815|TWO_SIDED|95.0|0.519|1.039|||Regression, Cox|||Cox proportional hazards regression model with outcome 60-day all-cause mortality (censored time to event variable with event = Death); Covariate: Treatment (IFX-1 + SOC)||1.039|0.519|0.0815
73941411|NCT04333420|147414691|SUPERIORITY||Risk Difference (RD)|7.352||||0.1553|TWO_SIDED|95.0|-2.762|17.465|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent|At Day 15||17.465|-2.762|0.1553
73941412|NCT04333420|147414691|SUPERIORITY||Risk Difference (RD)|8.078||||0.1181|TWO_SIDED|95.0|-1.968|18.125|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent|At Day 28||18.125|-1.968|0.1181
74039430|NCT04847141|147632421|SUPERIORITY||LS Mean Difference|0.03||||0.578|TWO_SIDED|95.0|-0.07|0.12|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.12|-0.07|0.5780
73941413|NCT04333420|147414692|SUPERIORITY||Risk Difference (RD)|-2.081||||0.4105|TWO_SIDED|95.0|-6.949|2.787|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients developing acute kidney failure; Risk difference and lower/upper limit of the CI are given in percent|||2.787|-6.949|0.4105
73941414|NCT04333420|147414693|SUPERIORITY||Hazard Ratio (HR)|0.539||||0.0422|TWO_SIDED|95.0|0.297|0.978||p-value refers to hazard ratio from cause-specific Cox proportional hazards model for first renal replacement therapy.|Regression, Cox|Covariate: Treatment (IFX-1 + SOC)||||0.978|0.297|0.0422
73941415|NCT00437645|147414716|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis for non-inferiority of valsartan/amlodipine 160/5 mg to amlodipine 10 mg alone with a non-inferiority margin of 3 mm Hg|Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-3.0|-0.44|||ANCOVA|||||-0.44|-3.00|
73941416|NCT03073148|147414740|EQUIVALENCE|alpha = 0.05||||||0.3577|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.3577
73941417|NCT03073148|147414740|EQUIVALENCE|alpha = 0.05||||||0.9917|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.9917
73941418|NCT03073148|147414741|EQUIVALENCE|alpha = 0.05||||||0.3239|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.3239
73941419|NCT03073148|147414741|EQUIVALENCE|alpha = 0.05||||||0.8343|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.8343
73941420|NCT03073148|147414742|EQUIVALENCE|alpha = 0.05||||||0.4134|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.4134
73941421|NCT03073148|147414742|EQUIVALENCE|alpha = 0.05||||||0.1192|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1192
73941422|NCT03073148|147414744|EQUIVALENCE|alpha = 0.05||||||0.1753||||||Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.|ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1753
73941423|NCT03073148|147414744|EQUIVALENCE|alpha = 0.05||||||0.1843|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1843
73941424|NCT03073148|147414745|EQUIVALENCE|alpha = 0.05||||||0.0765|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.0765
73941425|NCT03073148|147414745|EQUIVALENCE|alpha = 0.05||||||0.152|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1520
73941426|NCT03382782|147414758|SUPERIORITY||Mean Difference (Net)|0.36||||0.025|TWO_SIDED||||||ANOVA|degrees of freedom = (3, 172)||||||.025
73941427|NCT03382782|147414759|SUPERIORITY||Mean Difference (Net)|0.243||||0.784|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.784
73867752|NCT03916081|147280910|SUPERIORITY||LS Mean Difference|-5.82||||0.912|TWO_SIDED|-22.52|-22.52|10.88|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 2 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||10.880|-22.520|0.912
73867753|NCT03916081|147280910|SUPERIORITY||LS Mean Difference|-9.17||||0.548|TWO_SIDED|95.0|-25.686|7.341|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 2 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||7.341|-25.686|0.548
73867754|NCT03916081|147280910|SUPERIORITY||LS Mean Difference|-13.53||||0.164|TWO_SIDED|95.0|-30.157|3.097|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||3.097|-30.157|0.164
73867755|NCT03916081|147280910|SUPERIORITY||LS Mean Difference|-16.48||||0.049|TWO_SIDED|95.0|-32.921|-0.048|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||-0.048|-32.921|0.049
73867756|NCT03916081|147280911|SUPERIORITY||LS Mean Difference|-0.92||||0.44|TWO_SIDED|95.0|-2.412|0.568|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||0.568|-2.412|0.440
73867757|NCT03916081|147280911|SUPERIORITY||LS Mean Difference|-0.57||||0.875|TWO_SIDED|95.0|-2.061|0.914|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||0.914|-2.061|0.875
73867758|NCT03916081|147280912|SUPERIORITY|||||||0.352|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.352
73941428|NCT03382782|147414759|SUPERIORITY||Mean Difference (Net)|0.058||||0.81|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.810
73941429|NCT03382782|147414760|SUPERIORITY||Mean Difference (Net)|1.77||||0.174|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.174
73941430|NCT03382782|147414760|SUPERIORITY||Mean Difference (Net)|1.15||||0.286|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.286
73941431|NCT03382782|147414761|SUPERIORITY||Mean Difference (Net)|1.36||||0.261|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.261
74089132|NCT03575871|147731437|SUPERIORITY||Difference in Percentage|6.5||||0.0227|TWO_SIDED|95.0|1.4|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.6|1.4|0.0227
73941432|NCT03382782|147414761|SUPERIORITY||Mean Difference (Net)|0.012||||0.912|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.912
73941433|NCT03382782|147414763|SUPERIORITY||Mean Difference (Net)|1.74||||0.11|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 172||||||0.11
73941434|NCT03382782|147414764|SUPERIORITY||Mean Difference (Net)|1.18||||0.09|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 156||Mean systolic blood pressure||||0.09
73867759|NCT03916081|147280912|SUPERIORITY|||||||0.803|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.803
73867760|NCT03916081|147280912|SUPERIORITY|||||||0.25|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.250
73941435|NCT03382782|147414764|SUPERIORITY||Mean Difference (Net)|0.63||||0.05|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 156||Mean diastolic blood pressure||||0.05
73941436|NCT03382782|147414766|SUPERIORITY|Intention-to-treat analyses. General Health subscale.|Mean Difference (Net)|2.14||||0.121|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||||||0.121
73941437|NCT03382782|147414766|SUPERIORITY||Mean Difference (Net)|1.71||||0.193|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses. General Health subscale.||||0.193
73941438|NCT03382782|147414766|SUPERIORITY||Mean Difference (Net)|0.181||||0.835|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses. Bodily Pain subscale.||||0.835
73941439|NCT03382782|147414766|SUPERIORITY||Mean Difference (Net)|0.43||||0.513|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Bodily Pain subscale.||||0.513
73941440|NCT03382782|147414766|SUPERIORITY||Mean Difference (Net)|2.37||||0.097|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses, Physical Functioning subscale.||||0.097
73941441|NCT03382782|147414766|SUPERIORITY||Mean Difference (Net)|0.04||||0.184|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Physical Functioning subscale.||||0.184
73941442|NCT03382782|147414766|SUPERIORITY||Mean Difference (Net)|1.06||||0.347|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses. Emotional Well-Being subscale.||||0.347
73941443|NCT03382782|147414766|SUPERIORITY||Mean Difference (Net)|0.361||||0.549|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Emotional Well-Being subscale.||||0.549
73867761|NCT03916081|147280912|SUPERIORITY|||||||0.756|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.756
73867762|NCT03916081|147280912|SUPERIORITY|||||||0.097|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.097
73867763|NCT03916081|147280912|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.054
73867764|NCT03916081|147280913|SUPERIORITY|||||||0.178|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.178
73867765|NCT03916081|147280913|SUPERIORITY|||||||0.046|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.046
73867766|NCT03916081|147280913|SUPERIORITY|||||||0.469|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.469
73867767|NCT03916081|147280913|SUPERIORITY|||||||0.446|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.446
73941444|NCT03382782|147414767|SUPERIORITY||Mean Difference (Net)|0.157||||0.855|TWO_SIDED||||||ANOVA|Degrees of freedom = 2,182||Intention-to-treat analyses||||.855
73941445|NCT03382782|147414767|SUPERIORITY||Mean Difference (Net)|0.011||||0.915|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.915
73941446|NCT03382782|147414769|SUPERIORITY||Mean Difference (Net)|0.68||||0.508|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.508
73941447|NCT03382782|147414769|SUPERIORITY||Mean Difference (Net)|1.67||||0.198|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.198
73867768|NCT03916081|147280913|SUPERIORITY|||||||0.009|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.009
73941448|NCT01316510|147414771|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||Primary outcome (percentage of bifidobacteria in the final stool specimen)||||<0.01
73941449|NCT01316510|147414772|SUPERIORITY_OR_OTHER|||||||0.44|||||||t-test, 2 sided|||Secondary outcome (length of hospital stay) for all 24 infants (this included two infants with intestinal atresia, both in the placebo group)||||0.44
73941450|NCT00428090|147414773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.074|TWO_SIDED|95.0|-3.8|0.2||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-3.8|0.074
73941451|NCT00428090|147414773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.338|TWO_SIDED|95.0|-3.0|1.0||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.0|-3.0|0.338
73867769|NCT03916081|147280913|SUPERIORITY|||||||0.045|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.045
73867770|NCT03916081|147280914|SUPERIORITY|||||||0.317|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.317
73867771|NCT03916081|147280914|SUPERIORITY|||||||0.182|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.182
73867772|NCT03916081|147280914|SUPERIORITY|||||||0.485|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.485
73867773|NCT03916081|147280914|SUPERIORITY|||||||0.913|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.913
73867774|NCT03916081|147280914|SUPERIORITY|||||||0.288|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.288
73867775|NCT03916081|147280915|SUPERIORITY|||||||0.34|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.340
73867776|NCT03916081|147280915|SUPERIORITY|||||||0.146|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.146
73867777|NCT03916081|147280915|SUPERIORITY|||||||0.967|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.967
73867778|NCT03916081|147280915|SUPERIORITY|||||||0.088|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.088
73941452|NCT00428090|147414773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.602|TWO_SIDED|95.0|-3.5|2.1||Comparison between Placebo and Donepezil 10mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.1|-3.5|0.602
73941453|NCT00428090|147414774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.131|TWO_SIDED|95.0|-2.7|0.4||Comparison between Placebo and RSG XR 2 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-2.7|0.131
74008510|NCT05395104|147566790|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.1239|||||TWO_SIDED|90.0|0.9887|1.2776||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2776|0.9887|
73941454|NCT00428090|147414774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.315|TWO_SIDED|95.0|-2.4|0.8||Comparison between Placebo and RSG XR 8 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.8|-2.4|0.315
73941455|NCT00428090|147414774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.105|TWO_SIDED|95.0|-3.5|0.3||Comparison between Placebo and Donepezil 10 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-3.5|0.105
73941456|NCT00428090|147414775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.272|TWO_SIDED|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-2.2|0.272
73941457|NCT00428090|147414775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.297|TWO_SIDED|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.2|0.297
73941458|NCT00428090|147414775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.131|TWO_SIDED|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix||||0.4|-3.1|0.131
73941459|NCT00428090|147414776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.663|TWO_SIDED|95.0|-0.3|0.4||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-0.3|0.663
73941460|NCT00428090|147414776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.891|TWO_SIDED|95.0|-0.4|0.3||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.4|0.891
73941461|NCT00428090|147414776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.414|TWO_SIDED|95.0|-0.7|0.3||Comparison between Placebo and Donepezil 10 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|||0.3|-0.7|0.414
73941462|NCT00428090|147414777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.913|TWO_SIDED|95.0|-0.3|0.3||Comparison between Placebo and RSG XR 2 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix||||0.3|-0.3|0.913
73941463|NCT00428090|147414777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.276|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.276
73941464|NCT00428090|147414777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.025|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.025
73941465|NCT00428090|147414778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.939|TWO_SIDED|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.2|0.939
73941466|NCT00428090|147414778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.307
74008511|NCT01892306|147566810|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-A were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||.02
74008512|NCT01892306|147566811|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-D were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||0.02
74008513|NCT01892306|147566812|SUPERIORITY_OR_OTHER|||||||0.24|||||||Mixed Models Analysis|||Scores on the CSQ were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||0.24
74008514|NCT01892306|147566813|OTHER|||||||0.62|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores.||||.62
74008515|NCT01892306|147566813|OTHER|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores||||.03
74008516|NCT01892306|147566814|OTHER|||||||0.95|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.||||0.95
73941467|NCT00428090|147414778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.009|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.009
73974635|NCT04538352|147494642|OTHER|p value of contrast difference compared from MDI to Semaglutide group at specific time point, testing whether contrast difference is equal to 0, which means there is no difference between two groups. The determination of statistical significance was made using Bonferroni-adjusted p-value, setting the significance threshold at 0.01 after multiplicity correction.||||||0.009||||||p value is adjusted for the multiple comparison. The significance threshold is set to 0.01.|Bonferroni-adjusted p-value|||"Linear mixed effect model was conducted for each endpoint to assess mean change at each time point, with time, treatment groups, the interaction of treatment groups and time, and baseline variables included and adjusted in each model.~Mean change difference between patients with MDI and those with Semaglutide (MDI - Semaglutide)"||||0.009
73974636|NCT04538352|147494643|OTHER|p value of contrast difference compared from MDI to Semaglutide group at specific time point, testing whether contrast difference is equal to 0, which means there is no difference between two groups. The determination of statistical significance was made using Bonferroni-adjusted p-value, setting the significance threshold at 0.01 after multiplicity correction.|||||<|0.001||||||p value is adjusted for the multiple comparison. The significance threshold is set to 0.01.|Bonferroni-adjusted p-value|||"Linear mixed effect model was conducted for each endpoint to assess mean change at each time point, with time, treatment groups, the interaction of treatment groups and time, and baseline variables included and adjusted in each model.~Mean change difference between patients with MDI and those with Semaglutide (MDI - Semaglutide)"||||<0.001
73974637|NCT02278185|147494648|SUPERIORITY|||||||0.46|||||||Chi-squared|||The difference between metabolic syndrome and treatment were evaluated with the Chi-square test|This study did not meet it's target accrual goal and thus is underpowered to detect a statistically significant difference between the two groups.|||0.46
73974638|NCT02278185|147494648|SUPERIORITY|||||||0.46|||||||Chi-squared|||Cohort characteristics for Metabolic Syndrome were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst|Cohort characteristics for Metabolic Syndrome, the SPPB, the SHIM/FACT-P, and PSA were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. The Wilcoxon signed-rank test was utilized to examine the difference between Month 1 and Month 12 SPPB scores. The Wilcoxon rank-sum test was used to assess the difference of SHIM/FACT-P scores and PSA between arms. These tests were chosen to account for the non-normal distributions of the continuous variables. The difference between PSA progression between arms was examined using the Fisher Exact Test. A heat map of scores ordered by the highest average score was also created. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst|||0.46
73974639|NCT02278185|147494659|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||The results are presented in the following format: N Mean (Std Dev) Median (Q1, Q3). In all cases (Overall, Arm 1, and Arm 2) we fail to reject the null hypothesis that the samples come from the same population of scores at Month 1 versus Month 12 at the 0.05 significance level.||||0.5
73974640|NCT01288443|147494707|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 300 mg Q4W versus placebo~3. Alirocumab 100 mg Q2W versus placebo~4. Alirocumab 200 mg Q4W versus placebo~5. Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level"||||<0.0001
73974641|NCT01288443|147494707|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
73974642|NCT01288443|147494707|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
73941468|NCT00428090|147414779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.116|TWO_SIDED|95.0|-2.0|0.2||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-2.0|0.116
73974643|NCT01288443|147494707|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
73974644|NCT01288443|147494707|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
73974645|NCT01574716|147494730|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.6562|TWO_SIDED|95.0|0.77|1.5|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.50|0.77|= 0.6562
73974646|NCT01574716|147494731|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.4469|TWO_SIDED|95.0|0.82|1.57|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.57|0.82|=0.4469
73974647|NCT01574716|147494732|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.3153|TWO_SIDED|95.0|0.82|1.83|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.83|0.82|0.3153
73974648|NCT01574716|147494733|SUPERIORITY||Difference|-0.6|||=|1|TWO_SIDED|95.0|-12.0|10.9|||Log Rank|Two-sided log-rank test|Based on Cox PH model|Difference equal to (=) (MORAb 8.0 mg/kg + Gemcitabine/Docetaxel) minus (Placebo + Gemcitabine/Docetaxel). Confidence interval based on a normal approximation to the binomial distribution.||10.9|-12.0|= 1.000
74008517|NCT01892306|147566814|OTHER|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.||||0.03
74008518|NCT01892306|147566815|OTHER|||||||0.87|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores||||0.87
74008519|NCT01892306|147566815|OTHER|||||||0.37|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores||||0.37
73974649|NCT02438137|147494736|SUPERIORITY|In multiple linear regression models, the effect of DMF treatment on mean RDI change (beta-coefficient) was -11.3 respiratory events per hour (p=0.0124).|beta-coefficient for treatment effect|-11.3|STANDARD_ERROR_OF_MEAN|4.3||0.0124|TWO_SIDED||||||Regression, Linear|||Multiple linear regression models were used to calculate treatment effect (DMF or placebo) on mean RDI change, controlling for change in age, gender, BMI, time spent in supine sleep, and time spent in REM sleep.|A mixed effects model, which treated RDI as a repeated measure and used individual ID as random effect, adjusted for age, gender, BMI, time spent in supine sleep, was also conducted. In this model, the effect of DMF compared to placebo, controlling for all other covariates, is a 28% decrease in Month 4 RDI (p=0.033).|||0.0124
73974650|NCT04868617|147494776|SUPERIORITY||Mean Difference (Final Values)|-0.2|||=|0.015|TWO_SIDED|95.0|-0.3|-0.03|||Mixed Models Analysis|||||-0.03|-0.3|=0.015
73974651|NCT04868617|147494777|SUPERIORITY||Mean Difference (Final Values)|-0.8|||=|0.035|TWO_SIDED|95.0|-1.5|-0.1|||Mixed Models Analysis|||||-0.1|-1.5|=0.035
73974652|NCT02347332|147494802|SUPERIORITY|||||||0.8329|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.8329
73941469|NCT00428090|147414779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.816|TWO_SIDED|95.0|-0.9|1.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-0.9|0.816
73974653|NCT02347332|147494803|SUPERIORITY|||||||0.3576|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.3576
73941470|NCT00428090|147414779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.318|TWO_SIDED|95.0|-2.1|0.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.1|0.318
73941471|NCT00428090|147414779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.839|TWO_SIDED|95.0|-1.1|1.3||Comparison between Placebo and RSG XR 2 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.3|-1.1|0.839
73941472|NCT00428090|147414779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.165|TWO_SIDED|95.0|-0.3|2.0||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.0|-0.3|0.165
73941473|NCT00428090|147414779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.073|TWO_SIDED|95.0|-3.4|0.2||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-3.4|0.073
73974654|NCT02347332|147494804|SUPERIORITY|||||||0.467|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.467
73974655|NCT02347332|147494805|SUPERIORITY|||||||0.243|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.243
73974656|NCT02347332|147494806|SUPERIORITY|||||||0.6289|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.6289
74039431|NCT04847141|147632421|SUPERIORITY||LS Mean Difference|0.01||||0.9065|TWO_SIDED|95.0|-0.09|0.1|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.10|-0.09|0.9065
73974657|NCT01970007|147494807|OTHER||Freedom from MAE rate (%)|96.7|||<|0.0001|TWO_SIDED|95.0|93.5|98.6|||One-sided Exact binomial test||One-sided Exact binomial test|||98.6|93.5|<0.0001
73974658|NCT01970007|147494808|OTHER||12-month quantitative patency rate (%)|89.9|||<|0.0001|TWO_SIDED|95.0|85.1|93.4|||Binomial test for one proportion||Binomial test for one proportion|||93.4|85.1|<0.0001
73974659|NCT01970007|147494809|OTHER||Change from Baseline Mean|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.6||P-value is adjusted for multiplicity|paired t-test|A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05.||||-2.6|-3.5|<0.0001
73974660|NCT01970007|147494810|OTHER||Change from Baseline Mean|-4.2|||<|0.0001|TWO_SIDED|95.0|-4.7|-3.7||p-value is adjusted for multiplicity.|pair t-test|A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05||||-3.7|-4.7|<0.0001
73974661|NCT00754065|147494822|SUPERIORITY_OR_OTHER_LEGACY||F-statistic|9.3218||||0.0024||||||Comparison of EV/DNG vs. EE/NGM|ANOVA|||2-way ANOVA model with treatment and pain strata (headache and pelvic pain) as factors||||0.0024
74008520|NCT01892306|147566816|OTHER|||||||0.17|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO- Neuroticism scores.||||0.17
74008521|NCT01892306|147566816|OTHER|||||||0.04|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO-Neuroticism scores||||.04
74008522|NCT01892306|147566817|OTHER|||||||0.007|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.||||0.007
74008523|NCT01892306|147566817|OTHER|||||||0.14|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.||||.14
73867779|NCT03916081|147280916|SUPERIORITY||LS Mean Difference|0.38||||0.989|TWO_SIDED|95.0|-1.098|1.852|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||1.852|-1.098|0.989
73867780|NCT03916081|147280916|SUPERIORITY||LS Mean Difference|-0.1|||>|0.999|TWO_SIDED|95.0|-1.566|1.367|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||1.367|-1.566|>0.999
73867781|NCT03916081|147280916|SUPERIORITY||LS Mean Difference|0.6||||0.966|TWO_SIDED|95.0|-1.51|2.702|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||2.702|-1.510|0.966
73867782|NCT03916081|147280916|SUPERIORITY||LS Mean Difference|-0.34||||0.999|TWO_SIDED|95.0|-2.415|1.744|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||1.744|-2.415|0.999
73867783|NCT03916081|147280916|SUPERIORITY||LS Mean Difference|-0.25|||>|0.999|TWO_SIDED|95.0|-2.624|2.119|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||2.119|-2.624|>0.999
73867784|NCT03916081|147280916|SUPERIORITY||LS Mean Difference|-0.94||||0.798|TWO_SIDED|95.0|-3.285|1.398|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||1.398|-3.285|0.798
73941474|NCT00428090|147414779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.272|TWO_SIDED|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-2.2|0.272
73941475|NCT00428090|147414779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.297|TWO_SIDED|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.2|0.297
73941476|NCT00428090|147414779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.131|TWO_SIDED|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-3.1|0.131
73974662|NCT01074294|147494939|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.5845|TWO_SIDED|95.0|-1.8|3.19||The p-value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between Least Squares (LS) means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||3.19|-1.80|0.5845
73867785|NCT03916081|147280917|SUPERIORITY||LS Mean Difference|-0.78||||0.466|TWO_SIDED|95.0|-2.075|0.506|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||0.506|-2.075|0.466
73867786|NCT03916081|147280917|SUPERIORITY||LS Mean Difference|-1.03||||0.18|TWO_SIDED|95.0|-2.322|0.255|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||0.255|-2.322|0.180
74008524|NCT00789750|147566825|OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.49|-0.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.16|-0.49|<0.001
73941477|NCT00428090|147414780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.133|TWO_SIDED|95.0|-0.3|0.0||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.3|0.133
73941478|NCT00428090|147414780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.2|0.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.2|0.958
74008525|NCT00789750|147566826|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.24|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.10|-0.24|<0.001
73867787|NCT03916081|147280917|SUPERIORITY||LS Mean Difference|-0.43||||0.967|TWO_SIDED|95.0|-1.921|1.069|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||1.069|-1.921|0.967
74008526|NCT00789750|147566827|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.056||0.0002|TWO_SIDED|95.0|-0.32|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.10|-0.32|0.0002
73867788|NCT03916081|147280917|SUPERIORITY||LS Mean Difference|-0.72||||0.684|TWO_SIDED|95.0|-2.205|0.762|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||0.762|-2.205|0.684
73974663|NCT01074294|147494940|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8832|TWO_SIDED|95.0|-1.37|1.18||The p-value was derived using ANCOVA model with treatment and trial center as main effects and Week 5 value as covariate.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.18|-1.37|0.8832
73974664|NCT01074294|147494941|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.3864|TWO_SIDED|95.0|-0.72|1.86||The p-value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.86|-0.72|0.3864
73974665|NCT01074294|147494942|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.0061|TWO_SIDED|95.0|0.1|0.58||The p value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.58|0.10|0.0061
73974666|NCT01074294|147494943|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.6932|TWO_SIDED|95.0|-1.64|2.46||The p-value was derived from ANCOVA model, with treatment and trial center as main effects and Week 5 value as covariate.|ANCOVA||This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||2.46|-1.64|0.6932
73974667|NCT01074294|147494944|SUPERIORITY||Mean Difference (Final Values)|0.81||||0.2781|TWO_SIDED|95.0|-0.66|2.28||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||2.28|-0.66|0.2781
73867789|NCT03916081|147280917|SUPERIORITY||LS Mean Difference|-0.61||||0.856|TWO_SIDED|95.0|-2.221|1.003|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||1.003|-2.221|0.856
73974668|NCT01074294|147494944|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.4673|TWO_SIDED|95.0|-1.15|2.49||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||2.49|-1.15|0.4673
73867790|NCT03916081|147280917|SUPERIORITY||LS Mean Difference|-0.51||||0.932|TWO_SIDED|95.0|-2.105|1.089|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||1.089|-2.105|0.932
73974669|NCT01074294|147494944|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.5719|TWO_SIDED|95.0|-1.54|2.79||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||2.79|-1.54|0.5719
73974670|NCT01074294|147494944|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.6262|TWO_SIDED|95.0|-1.7|2.83||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||2.83|-1.70|0.6262
73974671|NCT01074294|147494944|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.2638|TWO_SIDED|95.0|-1.06|3.87||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||3.87|-1.06|0.2638
73974672|NCT01074294|147494945|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.3804|TWO_SIDED|95.0|-0.52|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.37|-0.52|0.3804
73974673|NCT01074294|147494945|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.6422|TWO_SIDED|95.0|-0.86|1.39||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.39|-0.86|0.6422
73974674|NCT01074294|147494945|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.6707|TWO_SIDED|95.0|-1.0|1.55||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.55|-1.00|0.6707
73974675|NCT01074294|147494945|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.6638|TWO_SIDED|95.0|-1.04|1.64||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.64|-1.04|0.6638
73974676|NCT01074294|147494945|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.2252|TWO_SIDED|95.0|-0.56|2.36||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.36|-0.56|0.2252
73867791|NCT03916081|147280918|SUPERIORITY|||||||0.637|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.637
73941479|NCT00428090|147414780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.085|TWO_SIDED|95.0|-0.5|0.0||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.5|0.085
73941480|NCT00428090|147414780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.102|TWO_SIDED|95.0|-0.4|0.0||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.4|0.102
73974677|NCT01074294|147494945|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.697|TWO_SIDED|95.0|-1.14|1.7||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.70|-1.14|0.6970
73974678|NCT01074294|147494946|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.6008|TWO_SIDED|95.0|-0.64|1.11||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.11|-0.64|0.6008
73974679|NCT01074294|147494946|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.5859|TWO_SIDED|95.0|-0.72|1.27||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.27|-0.72|0.5859
73941481|NCT00428090|147414780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.38|TWO_SIDED|95.0|-0.3|0.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.3|0.380
73974680|NCT01074294|147494946|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.7406|TWO_SIDED|95.0|-0.96|1.34||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.34|-0.96|0.7406
73974681|NCT01074294|147494946|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.8568|TWO_SIDED|95.0|-1.14|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.37|-1.14|0.8568
74031185|NCT05070429|147615896|SUPERIORITY||Maximum likelihood (MLE)|-1.96||||0.38|TWO_SIDED|95.0|-6.349|2.435|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare hearing-specific quality of life at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||2.435|-6.349|0.38
74031186|NCT02948777|147615898|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74031187|NCT02948777|147615899|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73974682|NCT01074294|147494946|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.6044|TWO_SIDED|95.0|-0.96|1.64||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.64|-0.96|0.6044
74031188|NCT02948777|147615900|OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
74031189|NCT02948777|147615901|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74031190|NCT02948777|147615902|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74031191|NCT02948777|147615903|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74031192|NCT02948777|147615904|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
74031193|NCT02948777|147615905|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
74031194|NCT02948777|147615906|OTHER|||||||0.31|||||||Kruskal-Wallis|||||||0.31
74031195|NCT02948777|147615907|OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
74031196|NCT02948777|147615908|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
73941482|NCT00428090|147414780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.006|TWO_SIDED|95.0|-0.7|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.7|0.006
73941483|NCT00428090|147414780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.939|TWO_SIDED|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.2|0.939
73941484|NCT00428090|147414780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.307
73941485|NCT00428090|147414780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.009|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.009
73941486|NCT00428090|147414781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.957|TWO_SIDED|95.0|-1.6|1.5||Comparison between Placebo and RSG XR 2mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.5|-1.6|0.957
73941487|NCT00428090|147414781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.693|TWO_SIDED|95.0|-1.4|2.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.2|-1.4|0.693
73941488|NCT00428090|147414781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.798|TWO_SIDED|95.0|-2.2|1.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.7|-2.2|0.798
73941489|NCT00428090|147414781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-1.7|1.8||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.8|-1.7|0.958
74031197|NCT02948777|147615909|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73867792|NCT03916081|147280918|SUPERIORITY|||||||0.124|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.124
73941490|NCT00428090|147414781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-2.1|2.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.1|-2.1|0.998
73941491|NCT00428090|147414781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.639||95.0|-1.7|2.8||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.8|-1.7|0.639
73941492|NCT00428090|147414781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.797|TWO_SIDED|95.0|-2.1|2.7||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.7|-2.1|0.797
73941493|NCT00428090|147414781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.942|TWO_SIDED|95.0|-2.9|2.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.7|-2.9|0.942
73941494|NCT00428090|147414781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.213|TWO_SIDED|95.0|-4.8|1.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-4.8|0.213
73941495|NCT00428090|147414782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.919|TWO_SIDED|95.0|-2.1|2.3||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.3|-2.1|0.919
74031198|NCT02948777|147615910|OTHER|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
74031199|NCT02948777|147615911|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
74031200|NCT02948777|147615912|OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
73867793|NCT03916081|147280918|SUPERIORITY|||||||0.196|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.196
73867794|NCT03916081|147280918|SUPERIORITY|||||||0.985|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.985
73867795|NCT03916081|147280918|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.401
73867796|NCT03916081|147280918|SUPERIORITY|||||||0.996|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.996
73867797|NCT00348309|147280948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.049|TWO_SIDED|95.0|-2.7|0.0||APOE4 negatives|Mixed Models Analysis|||||-0.0|-2.7|0.049
73867798|NCT00348309|147280948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.808|TWO_SIDED|95.0|-1.7|1.3||APOE4 negatives|Mixed Models Analysis|||||1.3|-1.7|0.808
73867799|NCT00348309|147280948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.035|TWO_SIDED|95.0|-1.9|-0.1||All except E4/E4s|Mixed Models Analysis|||||-0.1|-1.9|0.035
73941496|NCT00428090|147414782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.649|TWO_SIDED|95.0|-1.5|2.4||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.4|-1.5|0.649
73941497|NCT00428090|147414782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.279|TWO_SIDED|95.0|-1.1|3.6||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.1|0.279
73974683|NCT01074294|147494946|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.6772|TWO_SIDED|95.0|-1.08|1.66||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.66|-1.08|0.6772
73974684|NCT01074294|147494947|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.7881|TWO_SIDED|95.0|-0.87|1.15||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.15|-0.87|0.7881
73974685|NCT01074294|147494947|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8841|TWO_SIDED|95.0|-1.38|1.19||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.19|-1.38|0.8841
73867800|NCT00348309|147280948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.999|TWO_SIDED|95.0|-1.0|1.0||All except E4/E4s|Mixed Models Analysis|||||1.0|-1.0|0.999
73867801|NCT00348309|147280948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.02|TWO_SIDED|95.0|-1.9|-0.2||Full population|Mixed Models Analysis|||||-0.2|-1.9|0.020
73941498|NCT00428090|147414782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.498|TWO_SIDED|95.0|-1.8|3.6||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.8|0.498
74008527|NCT00789750|147566828|OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.077|<|0.001|TWO_SIDED|95.0|-0.51|-0.2|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.20|-0.51|<0.001
73867802|NCT00348309|147280948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.661|TWO_SIDED|95.0|-1.2|0.7||Full population|Mixed Models Analysis|||||0.7|-1.2|0.661
73867803|NCT00348309|147280949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.056|TWO_SIDED|95.0|-1.0|0.0||APOE4 negatives|Mixed Models Analysis|||||0.0|-1.0|=0.056
73867804|NCT00348309|147280949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.587|TWO_SIDED|95.0|-0.4|0.7||APOE4 negatives|Mixed Models Analysis|||||0.7|-0.4|=0.587
73867805|NCT00348309|147280949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.004|TWO_SIDED|95.0|-0.9|-0.2||All except E4/E4s|Mixed Models Analysis|||||-0.2|-0.9|=0.004
73867806|NCT00348309|147280949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.402|TWO_SIDED|95.0|-0.2|0.6||All except E4/E4s|Mixed Models Analysis|||||0.6|-0.2|=0.402
73867807|NCT00348309|147280949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.002|TWO_SIDED|95.0|-0.9|-0.2||Full population|Mixed Models Analysis|||||-0.2|-0.9|=0.002
73867808|NCT00348309|147280949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||=|0.478|TWO_SIDED|95.0|-0.2|0.5||Full population|Mixed Models Analysis|||||0.5|-0.2|=0.478
73867809|NCT00348309|147280950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||=|0.34|TWO_SIDED|95.0|-2.0|0.7||Week 8|Mixed Models Analysis|||||0.7|-2.0|=0.340
73867810|NCT00348309|147280950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.079|TWO_SIDED|95.0|-2.5|0.1||Week 8|Mixed Models Analysis|||||0.1|-2.5|=0.079
73867811|NCT00348309|147280950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||=|0.91|TWO_SIDED|95.0|-1.7|1.5||Week 16|Mixed Models Analysis|||||1.5|-1.7|=0.910
74089133|NCT03575871|147731437|SUPERIORITY||Difference in Percentage|16.8||||0.0001|TWO_SIDED|95.0|10.1|23.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.5|10.1|0.0001
74089134|NCT03575871|147731437|SUPERIORITY||Difference in Percentage|14.5||||0.0008|TWO_SIDED|95.0|7.7|21.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.3|7.7|0.0008
74089135|NCT03575871|147731437|SUPERIORITY||Difference in Percentage|25.8|||<|0.0001|TWO_SIDED|95.0|18.1|33.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||33.4|18.1|<0.0001
74089136|NCT03575871|147731437|SUPERIORITY||Difference in Percentage|18.5||||0.0003|TWO_SIDED|95.0|10.5|26.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||26.5|10.5|0.0003
74089137|NCT03575871|147731437|SUPERIORITY||Difference in Percentage|30.2|||<|0.0001|TWO_SIDED|95.0|21.4|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|21.4|<0.0001
74089138|NCT03575871|147731438|SUPERIORITY||Difference in Percentage|12.7||||0.0011|TWO_SIDED|95.0|6.5|18.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.9|6.5|0.0011
74089139|NCT03575871|147731438|SUPERIORITY||Difference in Percentage|32.6|||<|0.0001|TWO_SIDED|95.0|24.6|40.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.6|24.6|<0.0001
74089140|NCT03575871|147731438|SUPERIORITY||Difference in Percentage|28.3|||<|0.0001|TWO_SIDED|95.0|18.5|38.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.2|18.5|<0.0001
74089141|NCT03575871|147731438|SUPERIORITY||Difference in Percentage|52.8|||<|0.0001|TWO_SIDED|95.0|43.2|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||62.5|43.2|<0.0001
74089142|NCT03575871|147731438|SUPERIORITY||Difference in Percentage|28.0|||<|0.0001|TWO_SIDED|95.0|17.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|17.0|<0.0001
74089143|NCT03575871|147731438|SUPERIORITY||Difference in Percentage|46.1|||<|0.0001|TWO_SIDED|95.0|35.2|57.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||57.1|35.2|<0.0001
74089144|NCT03575871|147731438|SUPERIORITY||Difference in Percentage|36.2|||<|0.0001|TWO_SIDED|95.0|25.4|47.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.1|25.4|<0.0001
74089145|NCT03575871|147731438|SUPERIORITY||Difference in Percentage|49.6|||<|0.0001|TWO_SIDED|95.0|38.9|60.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.3|38.9|<0.0001
74089146|NCT03575871|147731439|SUPERIORITY||Difference in Percentage|1.9||||0.2261|TWO_SIDED|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-2.2|0.2261
74089147|NCT03575871|147731439|SUPERIORITY||Difference in Percentage|5.2||||0.0451|TWO_SIDED|95.0|0.3|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.0|0.3|0.0451
73867812|NCT00348309|147280950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.521|TWO_SIDED|95.0|-2.1|1.0||Week 16|Mixed Models Analysis|||||1.0|-2.1|0.521
74008528|NCT00789750|147566829|OTHER|||||||0.012|||||||Cochran-Mantel-Haenszel|||||||0.012
73941499|NCT00428090|147414782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.489|TWO_SIDED|95.0|-1.7|3.6||Comparison between Placebo and RSG XR 8 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.7|0.489
73941500|NCT00428090|147414782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.024|TWO_SIDED|95.0|0.5|7.0||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||7.0|0.5|0.024
73941501|NCT00428090|147414782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.385|TWO_SIDED|95.0|-1.6|4.2||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||4.2|-1.6|0.385
73941502|NCT00428090|147414782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.944|TWO_SIDED|95.0|-3.0|2.8||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.8|-3.0|0.944
73974686|NCT01074294|147494947|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.7589|TWO_SIDED|95.0|-1.61|1.17||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.17|-1.61|0.7589
73974687|NCT01074294|147494947|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.5375|TWO_SIDED|95.0|-1.01|1.93||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.93|-1.01|0.5375
73974688|NCT01074294|147494947|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.4456|TWO_SIDED|95.0|-0.92|2.08||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.08|-0.92|0.4456
73974689|NCT01074294|147494947|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.667|TWO_SIDED|95.0|-1.21|1.89||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.89|-1.21|0.6670
73974690|NCT01074294|147494948|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.9708|TWO_SIDED|95.0|-0.97|1.01||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.01|-0.97|0.9708
73974691|NCT01074294|147494948|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.397|TWO_SIDED|95.0|-0.65|1.63||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.63|-0.65|0.3970
73974692|NCT01074294|147494949|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9568|TWO_SIDED|95.0|0.68|1.5||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 7||1.50|0.68|0.9568
73974693|NCT01074294|147494949|SUPERIORITY||Risk Ratio (RR)|0.91||||0.6308|TWO_SIDED|95.0|0.63|1.31||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 9||1.31|0.63|0.6308
73941503|NCT00428090|147414782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.078|TWO_SIDED|95.0|-0.4|7.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||7.5|-0.4|0.078
73941504|NCT00428090|147414783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.635|TWO_SIDED|95.0|-0.8|0.5||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-0.8|0.635
73867813|NCT00348309|147280950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||=|0.154|TWO_SIDED|95.0|-0.5|3.0||Week 24|Mixed Models Analysis|||||3.0|-0.5|=0.154
73941505|NCT00428090|147414783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.194|TWO_SIDED|95.0|-0.2|1.1||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-0.2|0.194
73941506|NCT00428090|147414783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.325|TWO_SIDED|95.0|-1.3|0.4||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-1.3|0.325
73941507|NCT00428090|147414783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.109|TWO_SIDED|95.0|-0.1|1.2||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-0.1|0.109
73941508|NCT00428090|147414783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.032|TWO_SIDED|95.0|0.1|1.4||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.4|0.1|0.032
73941509|NCT00428090|147414783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.189|TWO_SIDED|95.0|-1.7|0.3||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-1.7|0.189
73974694|NCT01074294|147494949|SUPERIORITY||Risk Ratio (RR)|0.92||||0.6698|TWO_SIDED|95.0|0.64|1.32||The p-value was derived from CMH general association test controlling for study center|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 11||1.32|0.64|0.6698
73974695|NCT01074294|147494949|SUPERIORITY||Risk Ratio (RR)|0.76||||0.2012|TWO_SIDED|95.0|0.5|1.15||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 7||1.15|0.50|0.2012
73974696|NCT01074294|147494949|SUPERIORITY||Risk Ratio (RR)|0.78||||0.2365|TWO_SIDED|95.0|0.52|1.16||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 9||1.16|0.52|0.2365
73974697|NCT01074294|147494949|SUPERIORITY||Risk Ratio (RR)|0.65||||0.0312|TWO_SIDED|95.0|0.44|0.96||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 11||0.96|0.44|0.0312
73974698|NCT01074294|147494949|SUPERIORITY||Risk Ratio (RR)|1.12||||0.6408|TWO_SIDED|95.0|0.69|1.81||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 7||1.81|0.69|0.6408
73974699|NCT01074294|147494949|SUPERIORITY||Risk Ratio (RR)|1.24||||0.3467|TWO_SIDED|95.0|0.79|1.96||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 9||1.96|0.79|0.3467
73974700|NCT01074294|147494949|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9437|TWO_SIDED|95.0|0.65|1.59||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 11||1.59|0.65|0.9437
74031201|NCT02948777|147615913|OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
73941510|NCT00428090|147414783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.288|TWO_SIDED|95.0|-1.1|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-1.1|0.288
73941511|NCT00428090|147414783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.819|TWO_SIDED|95.0|-0.8|0.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.8|0.819
74031202|NCT02948777|147615914|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
74031203|NCT02948777|147615915|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
74031204|NCT02948777|147615916|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
74031205|NCT02948777|147615917|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
74031206|NCT02948777|147615918|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
74031207|NCT02948777|147615919|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
73867814|NCT00348309|147280950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.836|TWO_SIDED|95.0|-1.6|2.0||Week 24|Mixed Models Analysis|||||2.0|-1.6|=0.836
73867815|NCT00348309|147280950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.061|TWO_SIDED|95.0|-0.1|4.2||Week 48|Mixed Models Analysis|||||4.2|-0.1|0.061
73867816|NCT00348309|147280950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||=|0.566|TWO_SIDED|95.0|-2.9|1.6||Week 48|Mixed Models Analysis|||||1.6|-2.9|=0.566
73867817|NCT00348309|147280951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||=|0.414|TWO_SIDED|95.0|-1.3|0.5||Week 8|Mixed Models Analysis|||||0.5|-1.3|=0.414
73867818|NCT00348309|147280951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.931|TWO_SIDED|95.0|-1.0|1.1||Week 8|Mixed Models Analysis|||||1.1|-1.0|0.931
73867819|NCT00348309|147280951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.485|TWO_SIDED|95.0|-1.4|0.7||Week 16|Mixed Models Analysis|||||0.7|-1.4|0.485
73867820|NCT00348309|147280951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.55|TWO_SIDED|95.0|-0.8|1.5||Week 16|Mixed Models Analysis|||||1.5|-0.8|0.550
73867821|NCT00348309|147280951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.264|TWO_SIDED|95.0|-1.8|0.5||Week 24|Mixed Models Analysis|||||0.5|-1.8|0.264
73867822|NCT00348309|147280951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.732|TWO_SIDED|95.0|-1.5|1.0||Week 24|Mixed Models Analysis|||||1.0|-1.5|0.732
73941512|NCT00428090|147414783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.306|TWO_SIDED|95.0|-1.5|0.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-1.5|0.306
73941513|NCT00428090|147414784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.199|TWO_SIDED|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.01|0.199
73974701|NCT01074294|147494950|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.6357|TWO_SIDED|95.0|-1.3|2.12||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||2.12|-1.30|0.6357
73867823|NCT00348309|147280951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.043|TWO_SIDED|95.0|-2.9|0.0||Week 48|Mixed Models Analysis|||||-0.0|-2.9|0.043
74008529|NCT00789750|147566830|OTHER||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|-21.93|-7.49|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-7.49|-21.93|<0.0001
73867824|NCT00348309|147280951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.814|TWO_SIDED|95.0|-1.4|1.8||Week 48|Mixed Models Analysis|||||1.8|-1.4|0.814
73867825|NCT00348309|147280952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.87|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.870
73867826|NCT00348309|147280952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.617|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.617
73867827|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.789|TWO_SIDED|95.0|-5.2|6.9|||Mixed Models Analysis|||Week 12 Q1||6.9|-5.2|0.789
73867828|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.643|TWO_SIDED|95.0|-9.0|5.6||Week 12Q1|Mixed Models Analysis|||||5.6|-9.0|0.643
73867829|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.052|TWO_SIDED|95.0|-14.7|0.1||Week 24 Q1|Mixed Models Analysis|||||0.1|-14.7|0.052
73867830|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.481|TWO_SIDED|95.0|-14.0|6.6||Week 24 Q1|Mixed Models Analysis|||||6.6|-14.0|0.481
73867831|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.195|TWO_SIDED|95.0|-15.6|3.2||Week 36 Q1|Mixed Models Analysis|||||3.2|-15.6|0.195
73867832|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.857|TWO_SIDED|95.0|-12.9|10.7||Week 36 Q1|Mixed Models Analysis|||||10.7|-12.9|0.857
73867833|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.422|TWO_SIDED|95.0|-15.9|6.7||Week 48 Q1|Mixed Models Analysis|||||6.7|-15.9|0.422
73867834|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.562|TWO_SIDED|95.0|-15.7|8.6||Week 48 Q1|Mixed Models Analysis|||||8.6|-15.7|0.562
73867835|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8||||0.129|TWO_SIDED|95.0|-2.6|20.2||Week 12 Q2|Mixed Models Analysis|||||20.2|-2.6|0.129
73867836|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9||||0.194|TWO_SIDED|95.0|-4.0|19.9||Week 12 Q2|Mixed Models Analysis|||||19.9|-4.0|0.194
73867837|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.832|TWO_SIDED|95.0|-10.5|13.1||Week 24 Q2|Mixed Models Analysis|||||13.1|-10.5|0.832
73867838|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1||||0.351|TWO_SIDED|95.0|-6.8|19.1||Week 24 Q2|Mixed Models Analysis|||||19.1|-6.8|0.351
73867839|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.949|TWO_SIDED|95.0|-13.3|12.5||Week 36 Q2|Mixed Models Analysis|||||12.5|-13.3|0.949
73867840|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3||||0.253|TWO_SIDED|95.0|-6.0|22.6||Week 36 Q2|Mixed Models Analysis|||||22.6|-6.0|0.253
73867841|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.735|TWO_SIDED|95.0|-16.2|11.4||Week 48 Q2|Mixed Models Analysis|||||11.4|-16.2|0.735
73867842|NCT00348309|147280953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2||||0.046|TWO_SIDED|95.0|0.3|32.0||Week 48 Q2|Mixed Models Analysis|||||32.0|0.3|0.046
74008530|NCT00789750|147566831|OTHER|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
74008531|NCT00789750|147566832|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73941514|NCT00428090|147414784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.094|TWO_SIDED|95.0|-0.01|0.08||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.08|-0.01|0.094
73974702|NCT01074294|147494950|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.6536|TWO_SIDED|95.0|-1.56|2.48||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||2.48|-1.56|0.6536
73941515|NCT00428090|147414784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.187|TWO_SIDED|95.0|-0.02|0.09||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.09|-0.02|0.187
73941516|NCT00428090|147414784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.134|TWO_SIDED|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.01|0.134
73941517|NCT00428090|147414784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.05|0.05||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.05|-0.05|0.958
73941518|NCT00428090|147414784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.374|TWO_SIDED|95.0|-0.03|0.07||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.03|0.374
73941519|NCT00428090|147414785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.493|TWO_SIDED|95.0|-4.6|2.2||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.2|-4.6|0.493
73941520|NCT00428090|147414785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.883|TWO_SIDED|95.0|-3.2|3.7||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.7|-3.2|0.883
73941521|NCT00428090|147414785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.13|TWO_SIDED|95.0|-9.3|1.2||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-9.3|0.130
73974703|NCT01074294|147494950|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.9475|TWO_SIDED|95.0|-2.2|2.06||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||2.06|-2.20|0.9475
73941522|NCT00428090|147414785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.198|TWO_SIDED|95.0|-6.6|1.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.4|-6.6|0.198
73941523|NCT00428090|147414785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.441|TWO_SIDED|95.0|-5.9|2.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.6|-5.9|0.441
73941524|NCT00428090|147414785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.898|TWO_SIDED|95.0|-5.8|5.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||5.1|-5.8|0.898
73941525|NCT00428090|147414787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.027|TWO_SIDED|95.0|-2.1|-0.1||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-2.1|0.027
73941526|NCT00428090|147414787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.278|TWO_SIDED|95.0|-1.6|0.5||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-1.6|0.278
74008532|NCT00789750|147566833|OTHER|||||||0.132|||||||Cochran-Mantel-Haenszel|||||||0.132
73941527|NCT00428090|147414787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-1.2|1.1||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-1.2|0.993
73941528|NCT00428090|147414787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.196|TWO_SIDED|95.0|-2.0|0.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-2.0|0.196
73941529|NCT00428090|147414787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.353|TWO_SIDED|95.0|-1.9|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-1.9|0.353
73941530|NCT00428090|147414787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.427|TWO_SIDED|95.0|-2.2|0.9||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.9|-2.2|0.427
73941531|NCT00428090|147414788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.886|TWO_SIDED|95.0|-0.7|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.7|0.886
73941532|NCT00428090|147414788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.71|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.8|0.710
73974704|NCT01074294|147494950|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.3973|TWO_SIDED|95.0|-1.31|3.29||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||3.29|-1.31|0.3973
73974705|NCT01074294|147494950|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.2336|TWO_SIDED|95.0|-0.96|3.91||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||3.91|-0.96|0.2336
74008533|NCT00789750|147566834|OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
73941533|NCT00428090|147414788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.03|TWO_SIDED|95.0|0.1|1.8|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.8|0.1|0.030
73941534|NCT00428090|147414789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.139|TWO_SIDED|95.0|0.0|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.0|0.139
73941535|NCT00428090|147414789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.846|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.1|0.846
73941536|NCT00428090|147414789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.864|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.1|0.864
73941537|NCT00361140|147414809|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Chi-squared|||||||.007
73867843|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.914|TWO_SIDED|95.0|-2.3|2.0||Week 12 Thermometer|Mixed Models Analysis|||||2.0|-2.3|0.914
73867844|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.415|TWO_SIDED|95.0|-3.3|1.4||Week 12 Thermometer|Mixed Models Analysis|||||1.4|-3.3|0.415
74031208|NCT02948777|147615921|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
74031209|NCT02948777|147615922|OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
74031210|NCT02311478|147615923|OTHER|Given that this is a observational cohort design we do not use either non-inferiority or equivalence analysis. Using ANOVA we test for differences in the number of days per month of bleeding between the 90 days pre-insertion, the 90 days following insertion, and 91-180 days following insertion.|Mean Difference (Net)|1.77|STANDARD_ERROR_OF_MEAN|0.28|<|0.05|TWO_SIDED|95.0|1.2|2.3||The p-value is not adjusted for multiple comparisons.|ANOVA|df=2||The null hypothesis is that there is no difference between the number of days of bleeding per month at baseline and the days of bleeding per month during 90 days after insertion, and months or 91-180 days following insertion.||2.3|1.2|<0.05
74031211|NCT02311478|147615923|EQUIVALENCE|α of 0.05 or lower.|Mean Difference (Final Values)|0.93|||<|0.05|TWO_SIDED|95.0|0.36|1.5|||t-test, 2 sided|||The estimation parameter compares the 90 days following to the 90 days prior.||1.5|0.36|<0.05
74031212|NCT03242928|147615926|SUPERIORITY||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.037|=|0.021|TWO_SIDED|95.0|-0.161|-0.013|||ANCOVA|||||-0.013|-0.161|= 0.021
73941538|NCT00361140|147414810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.27||||0.07|TWO_SIDED|95.0|0.92|42.48|||Gray|Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16:1141-1154.||Sample size: dependent on dose escalation. Once the maximum tolerated dose (MTD) is reached, a total of 30 patients will be accrued to that level. If maximally tolerated AUC is level 1, a total of 30 patients will be treated on this level using tacrolimus and methotrexate as GVHD prophylaxis. This will provide 95% confidence intervals for 100-day non-relapse mortality and non-fatal toxicities with ½ widths not exceeding 0.18. Hazard ratios were calculated per the method of Gray (reference given)||42.48|0.92|.07
73941539|NCT00677833|147414831|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95 percent (%) confidence interval (CI) for the difference in ACPR (PCR corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \>= -10% points.|ACPR percent difference|-9.1|||||TWO_SIDED|95.0|-16.02|-2.18|||Kaplan-Meier curves|||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of Azithromycin/Chloroquine (AZ-CQ) at Day 28 is less than that of Artemether/Lumefantrine (AL); Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.||-2.18|-16.02|
73941540|NCT00677833|147414832|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \>= -10% points.|ACPR percent difference|-6.08|||||TWO_SIDED|95.0|-12.1|-0.05|||Kaplan-Meier curves|||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is less than that of AL; Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.||-0.05|-12.10|
73941541|NCT00677833|147414833|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.04|||||TWO_SIDED|95.0|-9.93|-0.15|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.||-0.15|-9.93|
73974706|NCT01074294|147494950|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.4553|TWO_SIDED|95.0|-1.55|3.44||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||3.44|-1.55|0.4553
74089148|NCT03575871|147731439|SUPERIORITY||Difference in Percentage|7.0||||0.0171|TWO_SIDED|95.0|1.8|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.3|1.8|0.0171
74089149|NCT03575871|147731439|SUPERIORITY||Difference in Percentage|17.7|||<|0.0001|TWO_SIDED|95.0|10.9|24.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.5|10.9|<0.0001
74089150|NCT03575871|147731439|SUPERIORITY||Difference in Percentage|11.5||||0.0018|TWO_SIDED|95.0|5.5|17.5||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.5|5.5|0.0018
74089151|NCT03575871|147731439|SUPERIORITY||Difference in Percentage|25.7|||<|0.0001|TWO_SIDED|95.0|18.3|33.1||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||33.1|18.3|<0.0001
74089152|NCT03575871|147731439|SUPERIORITY||Difference in Percentage|16.2||||0.0005|TWO_SIDED|95.0|8.8|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.6|8.8|0.0005
74089153|NCT03575871|147731439|SUPERIORITY||Difference in Percentage|27.6|||<|0.0001|TWO_SIDED|95.0|19.3|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.8|19.3|<0.0001
73941542|NCT00677833|147414833|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.74|||||TWO_SIDED|95.0|-12.15|-1.32|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||-1.32|-12.15|
73941543|NCT00677833|147414833|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.78|||||TWO_SIDED|95.0|-12.82|-0.75|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-0.75|-12.82|
74089154|NCT03575871|147731440|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.1|-2.3|<0.0001
73867845|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.063|TWO_SIDED|95.0|-4.9|0.1||Week 36 Thermometer|Mixed Models Analysis|||||0.1|-4.9|0.063
73867846|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.03|TWO_SIDED|95.0|-5.6|-0.3||Week 36 Thermometer|Mixed Models Analysis|||||-0.3|-5.6|0.030
73867847|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.392|TWO_SIDED|95.0|-1.5|3.8||Week 48 Thermometer|Mixed Models Analysis|||||3.8|-1.5|0.392
73867848|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.557|TWO_SIDED|95.0|-3.7|2.0||Week 48 Thermometer|Mixed Models Analysis|||||2.0|-3.7|0.557
73867849|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.32|TWO_SIDED|95.0|-0.01|0.03||Week 12 Utility|Mixed Models Analysis|||||0.03|-0.01|0.320
73867850|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.18|TWO_SIDED|95.0|-0.04|0.01||Week 12 Utility|Mixed Models Analysis|||||0.01|-0.04|0.180
73867851|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.498|TWO_SIDED|95.0|-0.02|0.04||Week 36 Utility|Mixed Models Analysis|||||0.04|-0.02|0.498
73867852|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.081|TWO_SIDED|95.0|-0.06|0.0||Week 36 Utility|Mixed Models Analysis|||||0.00|-0.06|0.081
73867853|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.077|TWO_SIDED|95.0|0.0|0.06||Week 48 Utility|Mixed Models Analysis|||||0.06|-0.00|0.077
73867854|NCT00348309|147280954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.64|TWO_SIDED|95.0|-0.04|0.03||Week 48 Utility|Mixed Models Analysis|||||0.03|-0.04|0.640
73941544|NCT00677833|147414833|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.92|||||TWO_SIDED|95.0|-14.59|0.76|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||0.76|-14.59|
74089155|NCT03575871|147731440|SUPERIORITY||Difference in LS mean|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.3|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.3|-3.5|<0.0001
73867855|NCT00348309|147280955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.105|TWO_SIDED|95.0|-1.6|0.2|||ANCOVA|||||0.2|-1.6|0.105
73867856|NCT00348309|147280955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.483|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|||||0.6|-1.3|0.483
73974707|NCT01074294|147494951|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.5647|TWO_SIDED|95.0|-0.7|1.27||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.27|-0.70|0.5647
74008534|NCT00789750|147566835|OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|2.15|<|0.001|TWO_SIDED|95.0|-20.62|-12.18|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-12.18|-20.62|<0.001
74089156|NCT03575871|147731440|SUPERIORITY||Difference in LS mean|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.3|-2.6|<0.0001
73867857|NCT00348309|147280956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.004|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||||-0.2|-0.9|0.004
73867858|NCT00348309|147280956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.554|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||||0.5|-0.3|0.554
73867859|NCT00348309|147280957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.292|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.292
73867860|NCT00348309|147280957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.297|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.297
73867861|NCT00348309|147280958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.598|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.598
73867862|NCT00348309|147280958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.073|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.073
73867863|NCT00348309|147280959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.006|TWO_SIDED|95.0|0.02|0.12|||ANCOVA|||||0.12|0.02|0.006
73867864|NCT00348309|147280959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.14|TWO_SIDED|95.0|-0.01|0.09|||ANCOVA|||||0.09|-0.01|0.140
73867865|NCT00348309|147280969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.027|TWO_SIDED|95.0|-1.2|-0.1||Week 12|Mixed Models Analysis|||||-0.1|-1.2|0.027
73867866|NCT00348309|147280969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.091|TWO_SIDED|95.0|-1.1|0.1||Week 12|Mixed Models Analysis|||||0.1|-1.1|0.091
73867867|NCT00348309|147280969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.268|TWO_SIDED|95.0|-1.1|0.3||Week 36|Mixed Models Analysis|||||0.3|-1.1|0.268
73867868|NCT00348309|147280969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.318|TWO_SIDED|95.0|-1.1|0.4||Week 36|Mixed Models Analysis|||||0.4|-1.1|0.318
73867869|NCT00348309|147280969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.03|TWO_SIDED|95.0|-1.6|-0.1||Week 48|Mixed Models Analysis|||||-0.1|-1.6|0.030
73867870|NCT00348309|147280969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.797|TWO_SIDED|95.0|-0.9|0.7||Week 48|Mixed Models Analysis|||||0.7|-0.9|0.797
73867871|NCT00622388|147280970|SUPERIORITY_OR_OTHER||Response rate|11.0|||||TWO_SIDED|95.0|5.0|20.0|||||Response rate is calculated as the number of responses divided by the number of participants treated, expressed as a percentage.|||20|5|
73867872|NCT02160145|147281040|OTHER||Treatment difference|1.271|||<|0.0001|TWO_SIDED|95.0|0.859|1.684||A 2-sided alpha of 0.05 was applied to the primary analysis of the primary endpoint.|ANCOVA|Weighted Analysis of Covariance (ANCOVA) with effects of treatment and randomization stratification factors and covariate baseline.||Tolvaptan versus placebo. Treatment difference in the change of eGFR assessed the efficacy of tolvaptan treatment as compared with placebo in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period.||1.684|0.859|<0.0001
73867873|NCT02160145|147281041|OTHER||Treatment difference|1.011|||<|0.0001|TWO_SIDED|95.0|0.618|1.403||A two-sided alpha of 0.05 was applied when the primary endpoint reached a two-sided alpha of 0.05.|Mixed Models Analysis|||Difference in treatment effect was derived from a linear mixed model with effects of treatment, time, treatment ime interaction, acute haemodynamic effect, pretreatment baseline, and randomization stratification factors. An unstructured variance matrix was assumed for the random intercept and time.||1.403|0.618|<0.0001
73867874|NCT06037408|147281047|SUPERIORITY||Mean Difference (Final Values)|-57.13|STANDARD_ERROR_OF_MEAN|2.759||0.0001|TWO_SIDED|95.0|-63.99|-50.27||Sidak's test was used to adjust for multiple comparisons.|ANOVA|Degrees of freedom, 42.19||||-50.27|-63.99|0.0001
73867875|NCT06037408|147281048|SUPERIORITY||Mean Difference (Final Values)|25.12|STANDARD_ERROR_OF_MEAN|4.459|<|0.0001|TWO_SIDED|95.0|13.26|36.99|||ANOVA|Degrees of freedom, 28.16.||||36.99|13.26|<0.0001
73867876|NCT04978818|147281049|NON_INFERIORITY|The anti-PRP IgG GMC for children receiving dose 1 of Vaxelis® was defined a priori as non-inferior if it was within a 1.5-fold margin of the GMC for children receiving dose 1 of PedvaxHIB®, corresponding to the lower bound of the 95% confidence interval (CI) of the IgG GMC ratio (Vaxelis® to PedvaxHIB®) being greater than 0.67.|Ratio of Geometric Mean Concentration|1.03||||0.85|TWO_SIDED|95.0|0.75|1.41|||Constrained Longitudinal Analysis||The lower bound of the 95% confidence interval was greater than the pre-specified non-inferiority margin of 0.67. Thus, Vaxelis® post-dose 1 anti-PRP IgG immunogenicity met the non-inferiority criterion compared to PedvaxHIB®.|||1.41|0.75|0.85
73867877|NCT04978818|147281050|OTHER|||||||0.39|||||||Chi-squared|||||||0.39
73867878|NCT04978818|147281051|OTHER|||||||0.64|||||||Chi-squared|||||||0.64
73867879|NCT04978818|147281052|OTHER|||||||0.87|||||||Chi-squared|||||||0.87
73867880|NCT04978818|147281053|OTHER|||||||0.3|||||||Chi-squared|||||||0.3
73867881|NCT04978818|147281054|OTHER|||||||0.15|||||||Chi-squared|||||||0.15
73974708|NCT01074294|147494951|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9739|TWO_SIDED|95.0|-1.15|1.12||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.12|-1.15|0.9739
73867882|NCT04978818|147281055|OTHER|||||||0.03|||||||Chi-squared|||||||0.03
73867883|NCT05399290|147281057|OTHER|Chi square analysis was conducted to detect any significant between group differences (100 mg vs 20 mg) in perceived acne severity.||||||0.677|||||||Chi-squared|||||||0.677
74008535|NCT00789750|147566836|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.31||0.1652|TWO_SIDED|95.0|-0.75|4.39|||ANCOVA|||Treatment difference = Colesevelam - Placebo||4.39|-0.75|0.1652
73867884|NCT05399290|147281057|OTHER|Friedman's test was conducted for the 100 mg treatment arm to detect any significant within group differences in perceived acne severity.||||||0.002|||||||Friedman's test|||||||0.002
73867885|NCT05399290|147281057|OTHER|Friedman's test was conducted for the 20 mg treatment arm to detect any significant within group differences in perceived acne severity.||||||0.018|||||||Fried|||||||0.018
73867886|NCT00659230|147281073|SUPERIORITY_OR_OTHER||Effect Size|-0.18||||0.723|TWO_SIDED|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|The analysis was conducted using a repeated-measures analysis of variance (ANOVA) model. The model consisted of two factors - treatment at two levels and time (5 time points including baseline) and group by time interaction.||0.27|-0.64|0.723
73867887|NCT00659230|147281074|SUPERIORITY||Effect Size|-0.07||||0.54|TWO_SIDED|90.0|-0.52|0.39|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.39|-.52|0.540
73867888|NCT00659230|147281075|SUPERIORITY||Effect size|-0.18||||0.951|TWO_SIDED|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.27|-0.64|0.951
73867889|NCT00659230|147281076|SUPERIORITY||Effect Size|0.11||||0.396|TWO_SIDED|90.0|-0.35|0.56|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.56|-0.35|0.396
73867890|NCT03109184|147281117|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED||||||||3-Month follow-up between groups odds ratio of DV perpetration|||||
73867891|NCT03109184|147281117|SUPERIORITY||Odds Ratio (OR)|0.61|||||TWO_SIDED||||||||9-month follow-up between group odds ratio of DV perpetration|||||
73867892|NCT03109184|147281117|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED||||||||3-month follow-up between groups odds ratio of DV victimization|||||
73867893|NCT03109184|147281117|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED||||||||9-month follow-up between groups odds ratio of DV victimization|||||
73867894|NCT03109184|147281118|SUPERIORITY||Effect Size (d)|-0.07|||||TWO_SIDED||||||||3-month follow-up between groups effect size of general aggression|||||
73941545|NCT00677833|147414833|SUPERIORITY_OR_OTHER||ACPR percent difference|-8.63|||||TWO_SIDED|95.0|-17.08|-0.18|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||-0.18|-17.08|
73941546|NCT00677833|147414834|SUPERIORITY_OR_OTHER||ACPR percent difference|-3.63|||||TWO_SIDED|95.0|-8.4|1.14|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||1.14|-8.40|
73941547|NCT00677833|147414834|SUPERIORITY_OR_OTHER||ACPR percent difference|-3.87|||||TWO_SIDED|95.0|-10.79|3.04|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||3.04|-10.79|
73941548|NCT00677833|147414834|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.66|||||TWO_SIDED|95.0|-13.55|2.22|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||2.22|-13.55|
73941549|NCT00677833|147414835|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.04|||||TWO_SIDED|95.0|-9.93|-0.15|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.||-0.15|-9.93|
73941550|NCT00677833|147414835|SUPERIORITY_OR_OTHER||ACPR percent difference|-7.71|||||TWO_SIDED|95.0|-14.54|-0.88|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||-0.88|-14.54|
73974709|NCT01074294|147494951|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.8077|TWO_SIDED|95.0|-1.4|1.09||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.09|-1.40|0.8077
73941551|NCT00677833|147414835|SUPERIORITY_OR_OTHER||ACPR percent difference|-15.09|||||TWO_SIDED|95.0|-26.24|-3.94|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-3.94|-26.24|
73974710|NCT01074294|147494951|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.6119|TWO_SIDED|95.0|-0.98|1.65||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.65|-0.98|0.6119
74008536|NCT00789750|147566837|OTHER||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-13.44|-6.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-6.16|-13.44|<0.0001
74031213|NCT03242928|147615927|SUPERIORITY||Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.077|=|0.025|TWO_SIDED|95.0|-0.331|-0.023|||ANOVA|||||-0.023|-0.331|= 0.025
73941552|NCT00677833|147414835|SUPERIORITY_OR_OTHER||ACPR percent difference|-21.76|||||TWO_SIDED|95.0|-34.14|-9.39|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.||-9.39|-34.14|
73941553|NCT00677833|147414835|SUPERIORITY_OR_OTHER||ACPR percent difference|-18.24|||||TWO_SIDED|95.0|-31.05|-5.43|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||-5.43|-31.05|
74031214|NCT03242928|147615928|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.038|=|0.072|TWO_SIDED|95.0|-0.146|0.006|||ANCOVA|||||0.006|-0.146|= 0.072
74031215|NCT03041116|147615937|SUPERIORITY||Difference in LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.8|=|0.9115|TWO_SIDED|95.0|-1.69|1.51||p-value was derived from test of contrast between treatment effects using LSM estimate, adjusted for baseline score and age group from Type III analysis. The test of contrast at Week 24 was considered the primary comparison.|Mixed Models Analysis|||||1.51|-1.69|=0.9115
74031216|NCT03041116|147615939|SUPERIORITY||Difference in LS Mean|2.0|STANDARD_ERROR_OF_MEAN|1.38|=|0.1421|TWO_SIDED|95.0|-0.7|4.78||p-value was derived from the test of contrast between treatment effects using the LSM estimate, adjusted for baseline score and age group from the Type III analysis. The test of contrast at week 24 was considered the primary comparison.|Mixed Models Analysis|||||4.78|-0.7|=0.1421
74031217|NCT00943319|147615941|OTHER||Median Survival time|161.0|||||TWO_SIDED|95.0|121.0|305.0|||Product limit survival estimate|||||305|121|
74031218|NCT00943319|147615942|OTHER||Median Disease Free Survival Time|172.0|||||TWO_SIDED|95.0|85.0|436.0||||||Estimated median survival time||436|85|
74031219|NCT02043301|147615943|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|120.96|||||TWO_SIDED|90.0|101.99|143.45|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||143.45|101.99|
73867895|NCT03109184|147281118|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||9-month follow-up between groups effect size of general aggression|||||
73867896|NCT03109184|147281119|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent attitudes support aggression|||||
73867897|NCT03109184|147281119|SUPERIORITY||Effect Size (d)|-0.17|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent attitudes support aggression|||||
73867898|NCT03109184|147281119|SUPERIORITY||Effect Size (d)|0.19|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent attitudes support aggression|||||
73867899|NCT03109184|147281119|SUPERIORITY||Effect Size (d)|0.2|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent attitudes support aggression|||||
73867900|NCT03109184|147281120|SUPERIORITY||Effect Size (d)|0.09|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent short-term self-regulation|||||
73867901|NCT03109184|147281120|SUPERIORITY||Effect Size (d)|0.36|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent short-term self-regulation|||||
73867902|NCT03109184|147281120|SUPERIORITY||Effect Size (d)|-0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent long-term self-regulation|||||
73867903|NCT03109184|147281120|SUPERIORITY||Effect Size (d)|0.11|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent long-term self-regulation|||||
73867904|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported open family communication|||||
73867905|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|0.06|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported open family communication|||||
73974711|NCT01074294|147494951|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.5513|TWO_SIDED|95.0|-0.94|1.76||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.76|-0.94|0.5513
73974712|NCT01074294|147494951|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.4185|TWO_SIDED|95.0|-0.81|1.95||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.95|-0.81|0.4185
73867906|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|-0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported problems in family communication|||||
74008537|NCT00789750|147566838|OTHER||Median Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|67.01||0.0004|TWO_SIDED|95.0|5.3|17.5|||ANCOVA||The treatment difference and its 95% confidence interval are estimated using the Hodges-Lehmann estimator and Moses method. The parameter dispersion Type is actually IQR of the Median Difference.|Treatment difference = Colesevelam - Placebo||17.5|5.3|0.0004
73867907|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|0.06|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported problems in family communication|||||
73867908|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|0.62|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported number of relationship topics discussed|||||
73867909|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|0.13|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported number of relationship topics discussed|||||
73867910|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported open family communication|||||
73867911|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported open family communication|||||
73867912|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|-0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported problems in family communication|||||
73867913|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|0.25|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported problems in family communication|||||
73867914|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|0.66|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported number of relationship topics discussed|||||
73867915|NCT03109184|147281121|SUPERIORITY||Effect Size (d)|-0.1|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported number of relationship topics discussed|||||
73867916|NCT03109184|147281122|SUPERIORITY||Effect Size (d)|0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent emotion-regulation|||||
73867917|NCT03109184|147281122|SUPERIORITY||Effect Size (d)|0.32|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent emotion-regulation|||||
73867918|NCT03109184|147281123|SUPERIORITY||Effect Size (d)|-0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent distress tolerance|||||
73867919|NCT03109184|147281123|SUPERIORITY||Effect Size (d)|0.23|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent distress tolerance|||||
73867920|NCT01031979|147281125|SUPERIORITY_OR_OTHER||Beta|-1.44|||<|0.001|TWO_SIDED|95.0|-2.29|-0.59|||mixed effects/hierarchical linear model|||||-0.59|-2.29|<0.001
73867921|NCT01031979|147281126|SUPERIORITY_OR_OTHER||Slope|-0.87||||0.39|TWO_SIDED||||||Hierarchical Linear Modeling|||||||.39
73867922|NCT01031979|147281127|SUPERIORITY_OR_OTHER||Slope|-0.55||||0.58|TWO_SIDED||||||Hierarchical Linear Modeling|||||||.58
73867923|NCT01031979|147281128|SUPERIORITY_OR_OTHER||Beta|-1.6||||0.03|TWO_SIDED|95.0|-2.71|-0.49|||Hierarchical Linear Modeling|||||-0.49|-2.71|.03
73867924|NCT03831100|147281132|SUPERIORITY||Mean Difference (Net)|-2.1||||0.25|TWO_SIDED|90.0|-5.0|0.9||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||0.9|-5.0|0.25
73867925|NCT03831100|147281133|SUPERIORITY||Mean Difference (Net)|-5.8||||0.006|TWO_SIDED|90.0|-9.1|-2.5||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||-2.5|-9.1|.006
73867926|NCT03831100|147281134|SUPERIORITY||Mean Difference (Net)|-7.9||||0.1|TWO_SIDED|90.0|-15.9|0.0||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||0.0|-15.9|.10
73867927|NCT03831100|147281135|SUPERIORITY||Mean Difference (Net)|-17.1||||0.002|TWO_SIDED|90.0|-25.6|-8.6||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear|||||-8.6|-25.6|.002
73867928|NCT03831100|147281136|SUPERIORITY||Mean Difference (Net)|-3.4||||0.3|TWO_SIDED|90.0|-8.8|2.0||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores|||2.0|-8.8|0.30
73867929|NCT03831100|147281137|SUPERIORITY||Median Difference (Net)|-9.7||||0.005|TWO_SIDED|90.0|-15.2|-4.2||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-4.2|-15.2|0.005
73867930|NCT03831100|147281138|SUPERIORITY||Mean Difference (Net)|-3.4||||0.064|TWO_SIDED|90.0|-6.4|0.4||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||0.4|-6.4|0.064
73867931|NCT03831100|147281139|SUPERIORITY||Mean Difference (Net)|-4.3||||0.046|TWO_SIDED|90.0|-7.8|-0.8||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.8|-7.8|0.046
73867932|NCT03831100|147281140|SUPERIORITY||Mean Difference (Net)|-1.5||||0.49|TWO_SIDED|90.0|-5.2|2.1||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||2.1|-5.2|0.49
73867933|NCT03831100|147281141|SUPERIORITY||Mean Difference (Net)|-3.1||||0.14|TWO_SIDED|90.0|-6.5|0.3||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||0.3|-6.5|0.14
73941554|NCT00677833|147414835|SUPERIORITY_OR_OTHER||ACPR Percent difference|-18.49|||||TWO_SIDED|95.0|-31.33|-5.65|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||-5.65|-31.33|
74031220|NCT02043301|147615943|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|94.93|||||TWO_SIDED|90.0|80.2|112.38|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||112.38|80.20|
73867934|NCT03831100|147281142|SUPERIORITY||Mean Difference (Net)|3.2||||0.082|TWO_SIDED|90.0|0.2|6.3||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||6.3|0.2|0.082
73867935|NCT03831100|147281143|SUPERIORITY||Mean Difference (Net)|2.7||||0.15|TWO_SIDED|90.0|-0.4|5.7||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||5.7|-0.4|0.15
73941555|NCT00677833|147414836|SUPERIORITY_OR_OTHER||ACPR percent difference|-4.67|||||TWO_SIDED|95.0|-10.6|1.25|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||1.25|-10.60|
73941556|NCT00677833|147414836|SUPERIORITY_OR_OTHER||ACPR percent difference|-13.07|||||TWO_SIDED|95.0|-24.21|-1.92|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-1.92|-24.21|
73941557|NCT00677833|147414836|SUPERIORITY_OR_OTHER||ACPR percent difference|-19.62|||||TWO_SIDED|95.0|-32.16|-7.08|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.||-7.08|-32.16|
73941558|NCT00677833|147414836|SUPERIORITY_OR_OTHER||ACPR percent difference|-16.38|||||TWO_SIDED|95.0|-29.42|-3.33|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||-3.33|-29.42|
73867936|NCT03831100|147281144|SUPERIORITY||Mean Difference (Net)|-2.2||||0.22|TWO_SIDED|90.0|-5.2|-0.7||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.7|-5.2|0.22
73941559|NCT00677833|147414836|SUPERIORITY_OR_OTHER||ACPR Percent difference|-16.94|||||TWO_SIDED|95.0|-30.04|-3.83|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)- (AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the Greenwood formula. Estimates for Day 42.||-3.83|-30.04|
73941560|NCT00677833|147414843|SUPERIORITY_OR_OTHER||percent difference|-5.89|||||TWO_SIDED|95.0|-11.02|-0.75|||large sample approximation to binomial|||Day 7||-0.75|-11.02|
73941561|NCT00677833|147414843|SUPERIORITY_OR_OTHER||percent difference|-7.55|||||TWO_SIDED|95.0|-13.14|-1.95|||large sample approximation to binomial|||Day 14||-1.95|-13.14|
73941562|NCT00677833|147414843|SUPERIORITY_OR_OTHER||percent difference|-7.6|||||TWO_SIDED|95.0|-13.61|-1.6|||large sample approximation to binomial|||Day 21||-1.60|-13.61|
73974713|NCT01074294|147494952|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.7556|TWO_SIDED|95.0|-0.8|1.09||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.09|-0.80|0.7556
73867937|NCT03831100|147281145|SUPERIORITY||Mean Difference (Net)|-2.9||||0.093|TWO_SIDED|90.0|-5.8|-0.1||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.1|-5.8|0.093
73867938|NCT01107665|147281165|OTHER||Log Rank HR|0.784||||0.49|TWO_SIDED|95.0|0.41|1.54|||Log Rank|||||1.54|.41|0.49
73867939|NCT02008227|147281168|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0003|TWO_SIDED|95.0|0.62|0.87|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.87|0.62|0.0003
73974714|NCT01074294|147494952|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.371|TWO_SIDED|95.0|-0.6|1.59||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.59|-0.60|0.3710
73974715|NCT01074294|147494952|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.8464|TWO_SIDED|95.0|-0.99|1.21||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.21|-0.99|0.8464
73867940|NCT02008227|147281168|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.62|0.86|||Log Rank|||Unstratified Analysis||0.86|0.62|0.0002
73867941|NCT02008227|147281169|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0102|TWO_SIDED|95.0|0.58|0.93|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.93|0.58|0.0102
73941563|NCT00677833|147414843|SUPERIORITY_OR_OTHER||percent difference|-9.26|||||TWO_SIDED|95.0|-15.64|-2.87|||Large sample approximation to binomial|||Day 28||-2.87|-15.64|
73941564|NCT00677833|147414843|SUPERIORITY_OR_OTHER||percent difference|-7.71|||||TWO_SIDED|95.0|-14.45|-0.97|||Large sample approximation to binomial|||Day 35||-0.97|-14.45|
73867942|NCT02008227|147281169|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.0052|TWO_SIDED|95.0|0.58|0.91|||Log Rank|||Unstratified Analysis||0.91|0.58|0.0052
73941565|NCT00677833|147414843|SUPERIORITY_OR_OTHER||percent difference|-8.52|||||TWO_SIDED|95.0|-15.43|-1.6|||Large sample approximation to binomial|||Day 42||-1.60|-15.43|
74008538|NCT00789750|147566839|OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|0.93||0.0003|TWO_SIDED|95.0|1.58|5.23|||ANCOVA|||Treatment difference = Colesevelam - Placebo||5.23|1.58|0.0003
73941566|NCT00677833|147414844|SUPERIORITY_OR_OTHER||percent difference|-9.51|||||TWO_SIDED|95.0|-18.27|-0.74|||Large sample approximation to binomial|||Day 7||-0.74|-18.27|
73941567|NCT00677833|147414844|SUPERIORITY_OR_OTHER||percent difference|-10.39|||||TWO_SIDED|95.0|-19.23|-1.55|||Large sample approximation to binomial|||Day 14||-1.55|-19.23|
73941568|NCT00677833|147414844|SUPERIORITY_OR_OTHER||percent difference|-12.75|||||TWO_SIDED|95.0|-21.45|-4.04|||Large sample approximation to binomial|||Day 21||-4.04|-21.45|
73941569|NCT00677833|147414844|SUPERIORITY_OR_OTHER||percent difference|-11.11|||||TWO_SIDED|95.0|-19.62|-2.6|||Large sample approximation to binomial|||Day 28||-2.60|-19.62|
73941570|NCT00677833|147414844|SUPERIORITY_OR_OTHER||percent difference|-10.34|||||TWO_SIDED|95.0|-18.97|-1.71|||Large sample approximation to binomial|||Day 35||-1.71|-18.97|
73941571|NCT00677833|147414844|SUPERIORITY_OR_OTHER||percent difference|-11.21|||||TWO_SIDED|95.0|-20.14|-2.28|||Large sample approximation to binomial|||Day 42||-2.28|-20.14|
73941572|NCT00677833|147414845|SUPERIORITY_OR_OTHER|||||||0.2564|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||0.2564
73941573|NCT00677833|147414846|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||<0.0001
73941574|NCT00677833|147414849|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||0.0006
73867943|NCT02008227|147281172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.4928|TWO_SIDED|95.0|0.82|1.1|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||1.10|0.82|0.4928
73867944|NCT02008227|147281172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.3596|TWO_SIDED|95.0|0.81|1.08|||Log Rank|||Unstratified Analysis||1.08|0.81|0.3596
73867945|NCT02008227|147281173|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3806|TWO_SIDED|95.0|0.74|1.12|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||1.12|0.74|0.3806
73867946|NCT02008227|147281173|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3249|TWO_SIDED|95.0|0.74|1.1|||Log Rank|||Unstratified Analysis||1.10|0.74|0.3249
73867947|NCT02008227|147281176|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.18|0.55|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.55|0.18|<0.0001
73867948|NCT02008227|147281176|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.55|||Log Rank|||Unstratified Analysis||0.55|0.21|<0.0001
73867949|NCT02008227|147281177|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31||||0.0006|TWO_SIDED|95.0|0.15|0.62|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.62|0.15|0.0006
73867950|NCT02008227|147281177|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.38||||0.0003|TWO_SIDED|95.0|0.22|0.65|||Log Rank|||Unstratified Analysis||0.65|0.22|0.0003
73867951|NCT02008227|147281181|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.0111|TWO_SIDED|95.0|0.55|0.93|||Log Rank|||Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.93|0.55|0.0111
73867952|NCT02008227|147281181|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.06||||0.6305|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Cough: Unstratified Analysis||1.33|0.84|0.6305
73867953|NCT02008227|147281181|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.7406|TWO_SIDED|95.0|0.81|1.16|||Log Rank|||Dyspnea: Unstratified Analysis||1.16|0.81|0.7406
73867954|NCT02008227|147281181|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.5221|TWO_SIDED|95.0|0.73|1.17|||Log Rank|||Arm/Shoulder Pain||1.17|0.73|0.5221
73867955|NCT02008227|147281196|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.0012|TWO_SIDED|95.0|0.7|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.92|0.70|0.0012
73867956|NCT02008227|147281197|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0045|TWO_SIDED|95.0|0.64|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.92|0.64|0.0045
73867957|NCT02008227|147281198|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.0012|TWO_SIDED|95.0|0.49|0.84|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.84|0.49|0.0012
73867958|NCT02008227|147281199|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.3|0.68|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.68|0.30|<0.0001
73867959|NCT02008227|147281200|SUPERIORITY_OR_OTHER_LEGACY||Stratified Hazard Ratio|0.96||||0.4981|TWO_SIDED|95.0|0.85|1.08|||Log Rank|||||1.08|0.85|0.4981
73867960|NCT02008227|147281202|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.32|||||TWO_SIDED|95.0|0.21|0.48||||||||0.48|0.21|
73867961|NCT01959841|147281221|NON_INFERIORITY|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(400mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||2.41e-06|||||||Modified Farrington-Manning test|||The non-inferiority of each ASP2151 dose level versus valaciclovir was assessed stepwise using a closed testing procedure.First step analysis was performed in the ASP2151(400mg) once daily.||||0.00000241
73867962|NCT01959841|147281221|NON_INFERIORITY|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(200mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||0.0688|||||||Modified Farrington-Manning test|||The analysis was performed in the ASP2151(200 mg) once daily only when non-inferiority of the ASP2151(400 mg) 0nce daily to valaciclovir 1000 mg three times daily was assumed.||||0.0688
73867963|NCT00666224|147281228|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.55||||0.0005|TWO_SIDED|95.0|0.4|0.77||Type of unifocal presentation at baseline, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization, and center effects as covariates.|Regression, Cox|||||0.77|0.40|0.0005
73867964|NCT00666224|147281229|SUPERIORITY_OR_OTHER||Rate ratio|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.61|||Quasi-Likelihood NB* Regression|"\*NB = Negative Binomial~Center and baseline number of enhancing lesions as covariates."||||0.61|0.29|<0.0001
73867965|NCT00666224|147281230|SUPERIORITY_OR_OTHER||Geometric means ratio|0.87||||0.0013|TWO_SIDED|95.0|0.79|0.95|||ANCOVA|Used log-transformed measurements comparing the adjusted geometric means of T2 volume. Center and baseline T2 volume used as covariates.||||0.95|0.79|0.0013
73867966|NCT00666224|147281233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.27|0.61||Type of unifocal presentation, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization and center effects as covariates.|Regression, Logistic|||||0.61|0.27|<0.0001
73867967|NCT01128192|147281234|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||Two sided P value|ANOVA|||Change in fasting plasma glucose level||||0.240
73867968|NCT01128192|147281234|SUPERIORITY_OR_OTHER|||||||0.339|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma glucose level||||0.339
73867969|NCT01128192|147281235|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
73867970|NCT01128192|147281235|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P Value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
73867971|NCT01128192|147281235|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P Value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
73867972|NCT01128192|147281235|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
73867973|NCT01128192|147281235|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
73867974|NCT01128192|147281235|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
73867975|NCT01128192|147281236|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level||||0.019
73941575|NCT05072457|147414852|OTHER||||||<|0.05|||||||ANOVA|||"MANOVA analysis with independent variable being the intervention condition (type of microphone used) and dependent variable being the performance on lateralization task.~Null hypothesis: There will be no statistically significant difference in lateralization test scores between the Roger On and the Roger Select in the experimental group."||||<.05
73941576|NCT05072457|147414853|OTHER||||||>|0.05|||||||ANOVA|||Independent variable: intervention condition (type of microphone used), Dependent variable: performance on spatial hearing task. Null hypothesis: There will be no statistically significant difference in spatial hearing test scores between the Roger On and the Roger Select in the experimental group.||||>.05
73941577|NCT02623322|147414915|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3031|TWO_SIDED|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel|||||6.19|-12.25|0.3031
74031221|NCT02043301|147615944|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|127.65|||||TWO_SIDED|90.0|107.19|152.02|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||152.02|107.19|
73867976|NCT01128192|147281236|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level||||<0.001
73867977|NCT01128192|147281237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
73867978|NCT01128192|147281237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
73867979|NCT01128192|147281237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
73941578|NCT02623322|147414915|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3324|TWO_SIDED|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel|||||6.76|-12.82|0.3324
73974716|NCT01074294|147494952|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.2664|TWO_SIDED|95.0|-0.53|1.91||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.91|-0.53|0.2664
73974717|NCT01074294|147494952|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.0876|TWO_SIDED|95.0|-0.17|2.42||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.42|-0.17|0.0876
73867980|NCT01128192|147281237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
73941579|NCT02623322|147414916|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3031|TWO_SIDED|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel|||||6.19|-12.25|0.3031
73867981|NCT01128192|147281237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
73867982|NCT01128192|147281237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
73867983|NCT01128192|147281238|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Baseline Insulin Level||||<0.001
73867984|NCT01128192|147281238|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Change in Baseline Insulin Level||||<0.001
73867985|NCT01128192|147281239|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes||||<0.001
73867986|NCT01128192|147281239|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes||||<0.001
73867987|NCT01128192|147281239|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
73867988|NCT01128192|147281239|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes||||<0.001
73867989|NCT01128192|147281239|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes||||<0.001
73867990|NCT01128192|147281239|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
73941580|NCT02623322|147414916|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3324|TWO_SIDED|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel|||||6.76|-12.82|0.3324
73941581|NCT02623322|147414920|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7858|TWO_SIDED|80.0|0.62|1.37|||Wilcoxon|||Total Symptom Score of \<=1||1.37|0.62|0.7858
73941582|NCT02623322|147414920|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.517|TWO_SIDED|80.0|0.59|1.36|||Wilcoxon|||Total Symptom Score of \<=1||1.36|0.59|0.5170
73941583|NCT02623322|147414920|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0312|TWO_SIDED|80.0|0.45|0.89|||Wilcoxon|||Total Symptom Score of \<=7||0.89|0.45|0.0312
73867991|NCT01128192|147281240|SUPERIORITY_OR_OTHER|||||||0.608|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Basal EGP||||0.608
73867992|NCT01128192|147281240|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Basal EGP||||0.132
74089157|NCT03575871|147731440|SUPERIORITY||Difference in LS mean|-3.1|||<|0.0001|TWO_SIDED|95.0|-3.8|-2.5|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.5|-3.8|<0.0001
74089158|NCT03575871|147731440|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.9|-2.3|<0.0001
73974718|NCT01074294|147494952|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.5119|TWO_SIDED|95.0|-0.89|1.77||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.77|-0.89|0.5119
73974719|NCT01074294|147494953|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.8986|TWO_SIDED|95.0|-1.03|1.18||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.18|-1.03|0.8986
73974720|NCT01074294|147494953|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.685|TWO_SIDED|95.0|-1.02|1.55||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.55|-1.02|0.6850
73974721|NCT01074294|147494953|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.7108|TWO_SIDED|95.0|-1.61|1.1||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.10|-1.61|0.7108
74089159|NCT03575871|147731440|SUPERIORITY||Difference in LS mean|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.3|-1.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.9|-3.3|<0.0001
74089160|NCT03575871|147731440|SUPERIORITY||Difference in LS mean|-1.4||||0.0006|TWO_SIDED|95.0|-2.2|-0.6|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.6|-2.2|0.0006
74089161|NCT03575871|147731440|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.4|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.4|-3.0|<0.0001
74089162|NCT03575871|147731441|SUPERIORITY||Difference in LS mean|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.8|-2.0|<0.0001
73867993|NCT01128192|147281241|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition||||0.178
74008539|NCT00789750|147566840|OTHER||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.52|<|0.0001|TWO_SIDED|95.0|-11.75|-5.78|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-5.78|-11.75|<0.0001
74089163|NCT03575871|147731441|SUPERIORITY||Difference in LS mean|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.8|-3.0|<0.0001
74089164|NCT03575871|147731441|SUPERIORITY||Difference in LS mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.2|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.2|-2.4|<0.0001
74089165|NCT03575871|147731441|SUPERIORITY||Difference in LS mean|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.3|-3.6|<0.0001
73867994|NCT01128192|147281241|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition||||0.111
73867995|NCT01128192|147281242|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in high-dose % EGP Inhibition||||0.573
73867996|NCT01128192|147281243|SUPERIORITY_OR_OTHER|||||||0.956|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)||||0.956
73867997|NCT01128192|147281243|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)||||0.125
73867998|NCT01128192|147281244|SUPERIORITY_OR_OTHER|||||||0.993|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)||||0.993
73867999|NCT01128192|147281244|SUPERIORITY_OR_OTHER|||||||0.956|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)||||0.956
73868000|NCT03335774|147281252|SUPERIORITY|To determine if the 'hydrocortisone' arm was indeed superior than 'placebo' to reduce swelling and itching associated with internal hemorrhoids||||||0.8918|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analyses were conducted using SAS software Version 9.4.All statistical tests were two-sided at a significance level of α = 0.05. Continuous data were presented using descriptive statistics (i.e. number of subjects, mean, SD, median, minimum, and maximum).Baseline value of each assessment was defined as the latest available assessment obtained prior to the first administration of the study drug.||||0.8918
73868001|NCT03335774|147281253|SUPERIORITY|To determine if the 'hydrocortisone' arm was indeed superior than 'placebo' to reduce swelling and itching associated with internal hemorrhoids||||||0.8323|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analyses were conducted using SAS software Version 9.4.All statistical tests were two-sided at a significance level of α = 0.05. Continuous data were presented using descriptive statistics (i.e. number of subjects, mean, SD, median, minimum, and maximum).Baseline value of each assessment was defined as the latest available assessment obtained prior to the first administration of the study drug.||||0.8323
73868002|NCT03354273|147281270|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 1: Sensitivity||||<0.0001
73868003|NCT03354273|147281270|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0182|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 1: Specificity||||0.0182
73868004|NCT03354273|147281270|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 2: Sensitivity||||<0.0001
73868005|NCT03354273|147281270|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0002|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 2: Specificity||||0.0002
73868006|NCT03354273|147281270|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 3: Sensitivity||||<0.0001
73868007|NCT03354273|147281270|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.997|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 3: Specificity||||0.9970
74031222|NCT02043301|147615944|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|86.16|||||TWO_SIDED|90.0|72.49|102.4|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||102.40|72.49|
74031223|NCT02043301|147615945|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|129.98|||||TWO_SIDED|90.0|106.76|158.27|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||158.27|106.76|
73868008|NCT03354273|147281270|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Majority Rule: Sensitivity||||<0.0001
73868009|NCT03354273|147281270|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0781|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Majority Rule: Specificity||||0.0781
73868010|NCT03354273|147281271|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|14.5|||<|0.0001|TWO_SIDED|95.0|6.5|22.4|||McNemar|The hypothesis tests were 1-sided McNemar's tests with a significance level of 0.025 for sensitivity.||Reader 1: Sensitivity||22.4|6.5|<0.0001
73868011|NCT03354273|147281271|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.4||||0.0004|TWO_SIDED|95.0|-4.9|9.7|||Nam's RMLE|||Reader 1: Specificity||9.7|-4.9|0.0004
73868012|NCT03354273|147281271|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|12.9||||0.0002|TWO_SIDED|95.0|4.7|21.0|||McNemar|||Reader 2: Sensitivity||21.0|4.7|0.0002
73868013|NCT03354273|147281271|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|4.9|||<|0.0001|TWO_SIDED|95.0|-2.1|11.8|||Nam's RMLE|||Reader 2: Specificity||11.8|-2.1|<0.0001
73868014|NCT03354273|147281271|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|13.3|||<|0.0001|TWO_SIDED|95.0|6.6|19.9|||McNemar|||Reader 3: Sensitivity||19.9|6.6|<0.0001
73941584|NCT02623322|147414920|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2044|TWO_SIDED|80.0|0.53|1.04|||Wilcoxon|||Total Symptom Score of \<=7||1.04|0.53|0.2044
73941585|NCT00772590|147414941|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||||||<0.01
73941586|NCT03813238|147414942|SUPERIORITY||LS mean difference|-1.2||||0.335|TWO_SIDED|95.0|-3.49|1.19|||Mixed Models Analysis|||The LS mean of the change in MDCRS part II total score from baseline to Week 15 was compared (TEV-50717 arm versus placebo) using a 1-sided test for superiority at a nominal significance level of α=0.025.||1.19|-3.49|0.335
73941587|NCT00420199|147414994|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-0.5|||||TWO_SIDED|95.0|-1.77|0.76|||ANCOVA|||Comparison in the change from baseline of erosion score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||0.76|-1.77|
73868015|NCT03354273|147281271|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|1.2||||0.0011|TWO_SIDED|95.0|-6.0|8.4|||Nam's RMLE|||Reader 3: Specificity||8.4|-6.0|0.0011
73868016|NCT03354273|147281271|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|11.6||||0.0003|TWO_SIDED|95.0|4.1|19.2|||McNemar|||Majority Rule: Sensitivity||19.2|4.1|0.0003
73868017|NCT03354273|147281271|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.1||||0.0004|TWO_SIDED|95.0|-5.0|9.3|||Nam's RMLE|||Majority Rule: Specificity||9.3|-5.0|0.0004
73868018|NCT03354273|147281272|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|24.4||||0.0127|TWO_SIDED|95.0|5.4|43.4|||McNemar|||Reader 1: Sensitivity||43.4|5.4|0.0127
73868019|NCT03354273|147281272|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|9.5||||0.0001|TWO_SIDED|95.0|-1.2|20.2|||Nam's RMLE|||Reader 1: Specificity||20.2|-1.2|0.0001
73868020|NCT03354273|147281272|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|22.0||||0.0195|TWO_SIDED|95.0|2.2|41.7|||McNemar|||Reader 2: Sensitivity||41.7|2.2|0.0195
73868021|NCT03354273|147281272|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.8||||0.0004|TWO_SIDED|95.0|-3.2|16.8|||Nam's RMLE|||Reader 2: Specificity||16.8|-3.2|0.0004
73868022|NCT03354273|147281272|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|17.1||||0.0174|TWO_SIDED|95.0|1.7|32.4|||McNemar|||Reader 3: Sensitivity||32.4|1.7|0.0174
73868023|NCT03354273|147281272|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|0.7||||0.024|TWO_SIDED|95.0|-9.9|11.3|||Nam's RMLE|||||11.3|-9.9|0.0240
73868024|NCT03354273|147281272|SUPERIORITY||Difference between PET MPI and SPECT MPI|17.1||||0.0448|TWO_SIDED|95.0|-1.5|35.6|||McNemar|||Majority Rule: Sensitivity||35.6|-1.5|0.0448
73868025|NCT03354273|147281272|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.8||||0.0004|TWO_SIDED|95.0|-3.4|17.0|||Nam's RMLE|||Majority Rule: Specificity||17.0|-3.4|0.0004
73868026|NCT03354273|147281273|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|12.0||||0.0116|TWO_SIDED|95.0|0.0|23.9|||McNemar|||Reader 1: Sensitivity||23.9|0.0|0.0116
73941588|NCT00420199|147414995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.103||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging score method between abatacept and placebo at Day 113 based on a nonparametric analysis of covariance model. Baseline and changes from baseline of the total wrist synovitis scores were ranked, and the model included the rank score for change from baseline as the dependent variable with treatment group as a main effect and the rank score for baseline as an additional covariate.||||0.103
73868027|NCT03354273|147281273|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.6||||0.0003|TWO_SIDED|95.0|-2.9|16.2|||Nam's RMLE|||Reader 1: Specificity||16.2|-2.9|0.0003
73868028|NCT03354273|147281273|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|6.8||||0.1085|TWO_SIDED|95.0|-5.2|18.9|||McNemar|||Reader 2: Sensitivity||18.9|-5.2|0.1085
73868029|NCT03354273|147281273|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|11.6|||<|0.0001|TWO_SIDED|95.0|2.1|21.1|||Nam's RMLE|||Reader 2: Specificity||21.1|2.1|<0.0001
74031224|NCT02043301|147615945|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|100.27|||||TWO_SIDED|90.0|82.54|121.82|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||121.82|82.54|
74031225|NCT02043301|147615950|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.35|||||TWO_SIDED|90.0|84.659|111.943|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||111.943|84.659|
74031226|NCT02043301|147615950|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|103.96|||||TWO_SIDED|90.0|90.405|119.557|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||119.557|90.405|
73941589|NCT00420199|147414997|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-3.48|||||TWO_SIDED|95.0|-6.0|-0.96|||ANCOVA|||Comparison in the change from baseline of Edema/Osteitis score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||-0.96|-6.00|
73941590|NCT00420199|147415000|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-4.71|||||TWO_SIDED|95.0|-8.0|-1.42|||ANCOVA|||Comparison in the change from baseline of RAMRIS score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||-1.42|-8.00|
73941591|NCT00420199|147415014|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69||||0.078||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging (MRI) score method between ABA and PLA at Day 113 based on a parametric analysis of covariance model (ANCOVA). The model included the score change from baseline as the dependent variable, treatment group as a main effect and baseline score as an additional covariate.||||0.078
73941592|NCT04393441|147415037|NON_INFERIORITY|MMRM with fixed effects=treatment, visit, visit by treatment interaction,Baseline total staining stratum(TSS),and Baseline TSS by visit interaction.|Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.57||0.0475|TWO_SIDED|95.0|0.01|2.27|||MMRM|||Change from Baseline in Total Staining Score at Day 90: The null hypothesis was that 011516X tear formulation was to be considered noninferior to Systane Ultra MD if the upper limit of 2-sided confidence interval (CI) was less than 2.3 units.||2.27|0.01|0.0475
73941593|NCT04393441|147415038|OTHER|No formal hypothesis was planned. The p-value for treatment differences is reported for reference.|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|16.32||0.9001|TWO_SIDED|95.0|-30.03|34.14|||MMRM|MMRM with fixed effects=treatment, visit, visit by treatment interaction, Baseline TSS, and Baseline TSS by visit interaction.||||34.14|-30.03|0.9001
73941594|NCT01215292|147415042|NON_INFERIORITY_OR_EQUIVALENCE|80% power to detect 20% difference in ITT|||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
73941595|NCT01215292|147415043|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
73974722|NCT01074294|147494953|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.9236|TWO_SIDED|95.0|-1.5|1.36||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.36|-1.50|0.9236
74089166|NCT03575871|147731441|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.9|-2.3|<0.0001
73941596|NCT01215292|147415044|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
73941597|NCT00977665|147415045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.603||||0.6984|TWO_SIDED|95.0|-3.677|2.47||A priori threshold for statistical significance is 0.05.|repeated measures model|Fixed effects: categorical week in trial by treatment interaction, center, and baseline UMSARS score.||||2.470|-3.677|0.6984
73941598|NCT00977665|147415054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.646|2.186||||||||2.186|0.646|
73941599|NCT05725317|147415061|NON_INFERIORITY|Noninferiority in distance visual acuity was declared if the upper confidence limit was less than 0.05.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens-by-visit interaction and sequence) and random (subject) effects. Difference = LID220365 minus LID006961. Sign is retained with the rounded value.|||0.00||
73941600|NCT02816138|147415080|OTHER||||||<|0.001|||||||Regression, Linear|For change in depression severity (MADRS) over time, we used a linear mixed effects model with autoregressive of order 1 (AR(1)) temporal process.||||||<0.001
73941601|NCT02816138|147415081|OTHER|||||||0.761|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.761
73941602|NCT02816138|147415082|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks||||0.084
73941603|NCT02816138|147415083|OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks||||0.073
74089167|NCT03575871|147731441|SUPERIORITY||Difference in LS mean|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.7|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.7|-3.1|<0.0001
73941604|NCT02816138|147415084|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.002
73941605|NCT02816138|147415085|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
73941606|NCT02816138|147415086|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.049
73941607|NCT02816138|147415087|OTHER|||||||0.502|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.502
73941608|NCT02816138|147415088|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.049
73941609|NCT02816138|147415089|OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.068
73941610|NCT00981084|147415090|SUPERIORITY_OR_OTHER||||||=|0.19||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .19
74008540|NCT00789750|147566841|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.77||0.7286|TWO_SIDED|95.0|-4.1|2.9|||ANCOVA|||Treatment difference = Colesevelam - Placebo||2.9|-4.1|0.7286
73868030|NCT03354273|147281273|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|13.7||||0.0017|TWO_SIDED|95.0|3.8|23.5|||McNemar|||Reader 3: Sensitivity||23.5|3.8|0.0017
73868031|NCT03354273|147281273|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.8||||0.0034|TWO_SIDED|95.0|-6.6|12.1|||Nam's RMLE|||Reader 3: Specificity||12.1|-6.6|0.0034
73868032|NCT03354273|147281273|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|7.7||||0.0641|TWO_SIDED|95.0|-3.6|19.0|||McNemar|||Majority Rule: Sensitivity||19.0|-3.6|0.0641
73868033|NCT03354273|147281273|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|5.0||||0.001|TWO_SIDED|95.0|-4.6|14.6|||Nam's RMLE|||Majority Rule: Specificity||14.6|-4.6|0.0010
73868034|NCT03354273|147281274|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|11.0||||0.0294|TWO_SIDED|95.0|-2.6|24.6|||McNemar|||Reader 1: Sensitivity||24.6|-2.6|0.0294
73868035|NCT03354273|147281274|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|3.9||||0.0117|TWO_SIDED|95.0|-8.3|16.1|||Nam's RMLE|||Reader 1: Specificity||16.1|-8.3|0.0117
73868036|NCT03354273|147281274|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|6.6||||0.1444|TWO_SIDED|95.0|-7.1|20.3|||McNemar|||Reader 2: Sensitivity||20.3|-7.1|0.1444
73868037|NCT03354273|147281274|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|11.7||||0.0001|TWO_SIDED|95.0|-0.4|23.7|||Nam's RMLE|||Reader 2: Specificity||23.7|-0.4|0.0001
73868038|NCT03354273|147281274|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|8.8||||0.044|TWO_SIDED|95.0|-1.3|18.9|||McNemar|||Reader 3: Sensitivity||18.9|-1.3|0.0440
73868039|NCT03354273|147281274|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|7.8||||0.0022|TWO_SIDED|95.0|-4.8|20.3|||Nam's RMLE|||Reader 3: Specificity||20.3|-4.8|0.0022
73868040|NCT03354273|147281274|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|4.4||||0.2164|TWO_SIDED|95.0|-8.4|17.2|||McNemar|||Majority Rule: Sensitivity||17.2|-8.4|0.2164
73868041|NCT03354273|147281274|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|9.7||||0.0006|TWO_SIDED|95.0|-2.6|22.0|||Nam's RMLE|||Majority Rule: Specificity||22.0|-2.6|0.0006
73868042|NCT00746863|147281281|SUPERIORITY_OR_OTHER|||||||0.0251||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A 2.0 cm difference on a 10.0 cm VAS scale was clinically significant. Assuming a power of 80% to detect a 2.0 difference on scores between groups, standard deviation of 2.2, an α of 0.05, then, 21 patients would be needed in each group for a total of 42 subjects. A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.||||0.0251
73868043|NCT00746863|147281282|SUPERIORITY_OR_OTHER|||||||0.0923||95.0||||Adjusted for multiple comparisions|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.||||0.0923
73868044|NCT00746863|147281283|SUPERIORITY_OR_OTHER|||||||0.4756||95.0|||||Chi-squared|||Chi square was performed to compared the two groups and the patient's ability to pass their voiding trial prior to discharge||||0.4756
73868045|NCT00746863|147281284|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.||||0.258
73868046|NCT00746863|147281285|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.||||0.435
73868047|NCT04207749|147281287|NON_INFERIORITY|Noninferiority in CLCDVA was declared if the upper confidence limit was less than 0.10 logMAR.|Least Squares Mean Difference|0.01|||||TWO_SIDED|95.0|0.0|0.02||Since noninferiority hypotheses are being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Mixed effects repeated measures||Least squares mean difference (LID015385 minus Biofinity).|||0.02|-0.00|
73868048|NCT04207749|147281288|NON_INFERIORITY|Proportion of subjects is presented. Noninferiority in proportion of subjects achieving CLCDVA 20/20 or better in each eye was declared if the lower confidence limit was greater than -0.10.|Difference in proportion|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||Since noninferiority hypotheses are being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Farrington-Manning||Lens difference (LID015385 minus Biofinity)|||0.04|-0.06|
73868049|NCT00244101|147281298|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.59|1.03||||||PS group used as standard of care. Relative risk and 95 % CI calculated for PS (reference) versus ISX or NCPAP.||1.03|0.59|
73868050|NCT00244101|147281298|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.25|1.27||||||PS group used as standard of care. Relative risk and 95% CI calculated for PS (reference) versus NCPAP.||1.27|0.25|
73868051|NCT00244101|147281299|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.49|1.94||||||PS group used as standard of care. Relative risk and 95 % CI calculated for PS (reference) versus ISX.||1.94|0.49|
73868052|NCT00244101|147281299|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.64|1.09||||||PS group used as standard of care. Relative risk and 95% CI calculated for PS (reference) versus NCPAP.||1.09|0.64|
73868053|NCT01504841|147281301|OTHER||%|36.4|||||TWO_SIDED|95.0|10.9|69.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE.|||69.2|10.9|
73868054|NCT01504841|147281301|OTHER||%|100.0|||||TWO_SIDED|95.0|39.8|100.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE.|||100|39.8|
73868055|NCT01504841|147281304|OTHER||%|18.2|||||TWO_SIDED|95.0|2.5|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE at least possibly related to study medications.|||51.8|2.5|
73868056|NCT01504841|147281304|OTHER||%|0.0|||||TWO_SIDED|95.0|0.0|60.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE at least possibly related to study medication.|||60.2|0|
73868057|NCT01504841|147281305|OTHER||%|18.2|||||TWO_SIDED|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.||51.8|2.3|
73868058|NCT01504841|147281305|OTHER||%|25.0|||||TWO_SIDED|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.||80.6|0.6|
73974723|NCT01074294|147494953|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.8576|TWO_SIDED|95.0|-1.35|1.61||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.61|-1.35|0.8576
73868059|NCT01504841|147281305|OTHER||%|27.3|||||TWO_SIDED|95.0|6.0|61.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.||61|6|
73868060|NCT01504841|147281305|OTHER||%|75.0|||||TWO_SIDED|95.0|19.4|99.4|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.||99.4|19.4|
73868061|NCT01504841|147281309|OTHER||%|9.1|||||TWO_SIDED|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 12, percentage of participants with a \>5% decline in absolute CD4 %.|Week 12 time point.||41.3|0.2|
73868062|NCT01504841|147281309|OTHER||%|50.0|||||TWO_SIDED|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 12, percentage of participants with a \>5% decline in absolute CD4 %.|Week 12 time point.||93.2|6.8|
73868063|NCT01504841|147281309|OTHER||%|9.1|||||TWO_SIDED|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants with a \>5% decline in absolute CD4 %.|Week 24 time point.||41.3|0.2|
73868064|NCT01504841|147281309|OTHER||%|25.0|||||TWO_SIDED|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants with a \>5% decline in absolute CD4 %.|Week 24 time point.||80.6|0.6|
73868065|NCT01504841|147281309|OTHER||%|18.2|||||TWO_SIDED|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants with a \>5% decline in absolute CD4 %.|Week 48 time point.||51.8|2.3|
73868066|NCT01504841|147281309|OTHER||%|50.0|||||TWO_SIDED|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants with a \>5% decline in absolute CD4 %.|Week 48 time point.||93.2|6.8|
73868067|NCT00741013|147281351|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Only a single statistical analysis was performed upon completion of the study.|ANOVA|||One-way analysis of variance was performed to determine whether lovastatin or rhAPC effectively reduced endotoxin-induced lung inflammation.||||<0.05
73868068|NCT01496469|147281368|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3||||0.882|TWO_SIDED|95.0|-3.9|3.4||Analysis of covariance (ANCOVA) model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.|ANCOVA|||A total of 120 enrolled participants (60 participants per treatment group) was sufficient to achieve 80 percent (%) power to detect a difference of 6.0 mmHg between the placebo and febuxostat 80 mg treatment groups by a 2 sample t-test of the mean change from Baseline at Week 6 in 24-hour mean ambulatory SBP with a 2-sided significance level of 5%.||3.4|-3.9|0.882
73868069|NCT01496469|147281369|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6||||0.613|TWO_SIDED|95.0|-1.9|3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.||3.2|-1.9|0.613
74008541|NCT00789750|147566842|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0653|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Treatment difference = Colesevelam - Placebo||0.0|-0.4|0.0653
73941611|NCT00981084|147415090|SUPERIORITY_OR_OTHER||||||=|0.0005||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .0005
73941612|NCT00981084|147415090|SUPERIORITY_OR_OTHER||||||=|0.21||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .21
73941613|NCT00981084|147415090|SUPERIORITY_OR_OTHER||||||=|0.1||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .10
73941614|NCT00981084|147415091|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the CPT, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.33
73941615|NCT00981084|147415092|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Stroop, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.37
73941616|NCT00981084|147415093|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Word Generation, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.53
73974724|NCT01074294|147494953|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.8483|TWO_SIDED|95.0|-1.67|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.37|-1.67|0.8483
73974725|NCT01074294|147494954|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6976|TWO_SIDED|95.0|-0.22|0.15||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||0.15|-0.22|0.6976
73974726|NCT01074294|147494954|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6986|TWO_SIDED|95.0|-0.25|0.17||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||0.17|-0.25|0.6986
73974727|NCT01074294|147494954|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.6507|TWO_SIDED|95.0|-0.3|0.19||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||0.19|-0.30|0.6507
73974728|NCT01074294|147494954|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.655|TWO_SIDED|95.0|-0.32|0.2||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||0.20|-0.32|0.6550
73941617|NCT04450108|147415101|SUPERIORITY|The change of FeNO values will be estimated in ANCOVA with baseline values as the covariable and will be reported as percent change together with the 95%-confidence interval.|||||<|0.001|||||||ANCOVA|||Since the effect size of the change (mean change / standard deviation) is on the order of 1 (resulting in N=10 and 13 for power = 80% and 90%, respectively) and therefore large, the sample size is not determined by the primary objective but by the necessity to achieve representative data of FeNO measurement data over all age groups, measurement ranges (\<, ≥ cut off) and sites. Thus, 120 subjects will be recruited.||||<0.001
74008542|NCT00789750|147566843|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.8862|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||Treatment difference = Colesevelam - Placebo||1.3|-1.5|0.8862
74008543|NCT02374021|147566894|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.79|TWO_SIDED|95.0|-0.19|0.15|||ANCOVA|||||0.15|-0.19|0.79
74008544|NCT02374021|147566895|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.05|TWO_SIDED|95.0|-0.14|0.17|||ANCOVA|||||0.17|-0.14|0.05
74008545|NCT02374021|147566896|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.05|TWO_SIDED|95.0|-0.11|0.18|||ANCOVA|||||0.18|-0.11|0.05
74008546|NCT02374021|147566897|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.05|TWO_SIDED|95.0|-0.2|0.19|||ANCOVA|||||0.19|-0.20|0.05
73868070|NCT01496469|147281370|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-3.9|-2.9||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.||-2.9|-3.9|<0.001
73868071|NCT01357551|147281374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|0.78||0.04|TWO_SIDED|95.0|0.07|3.13||A priori threshold was p\<.05|Mixed Models Analysis|Parameters included common intercept, initial weight loss stratum, dummy-coded time, and indicators for the maintenance X each follow-up time point||The sample size estimate was based on the primary hypothesis that patients randomized to receive the maintenance intervention would have less mean weight regain at week 56 than those randomized to usual care. The week 0 standard deviation was estimated as 24.6kg, the correlation between week 0 and week 56 as 0.95, and the week 56 dropout rate as 10%. To detect a difference of 3.5 kg with 90% power and a type I error rate of 5%, 230 total (115 in each group) randomized patients were needed.||3.13|.07|.04
73868072|NCT01357551|147281375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-125.49|STANDARD_ERROR_OF_MEAN|78.64||0.11|TWO_SIDED|95.0|-280.71|29.72|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction||The hypothesis was that patients randomized to receive the maintenance intervention would have less caloric intake at week 56 than those randomized to usual care.||29.72|-280.71|.11
73868073|NCT01357551|147281376|SUPERIORITY_OR_OTHER||incidence rate ratio|1.03|STANDARD_ERROR_OF_MEAN|0.26||0.91|TWO_SIDED|95.0|0.63|1.68|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of walking per week at week 56 than those randomized to usual care.||1.68|0.63|.91
73868074|NCT01357551|147281377|SUPERIORITY_OR_OTHER||incidence rate ratio|1.07|STANDARD_ERROR_OF_MEAN|0.35||0.83|TWO_SIDED|95.0|0.57|2.03|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of moderate physical activity per week at week 56 than those randomized to usual care.||2.03|0.57|.83
73868075|NCT05362058|147281378|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.09|||||TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||||0.04|-0.22|
73868076|NCT05362058|147281379|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.26|0.13|||ANCOVA|||||0.13|-0.26|
73868077|NCT05362058|147281380|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.11|||||TWO_SIDED|95.0|-0.28|0.07|||ANCOVA|||||0.07|-0.28|
73868078|NCT05362058|147281381|SUPERIORITY||LS Mean Difference|-0.09||||0.188|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||||0.04|-0.22|0.188
73868079|NCT05362058|147281382|SUPERIORITY||LS Mean Difference|3.09||||0.043|TWO_SIDED|95.0|0.09|6.08|||ANCOVA|||||6.08|0.09|0.043
73868080|NCT05362058|147281383|SUPERIORITY||LS Mean Difference|-0.06||||0.26|TWO_SIDED|95.0|-0.17|0.05|||ANCOVA|||||0.05|-0.17|0.260
73868081|NCT05362058|147281384|SUPERIORITY||LS Mean Difference|0.27||||0.848|TWO_SIDED|95.0|-2.48|3.02|||ANCOVA|||||3.02|-2.48|0.848
73868082|NCT05362058|147281385|SUPERIORITY||LS Mean Difference|5.18||||0.014|TWO_SIDED|95.0|1.06|9.3|||ANCOVA|||Week 26 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 26 were imputed by return-to-baseline multiple imputations approach.||9.30|1.06|0.014
73868083|NCT05362058|147281385|SUPERIORITY||LS Mean Difference|0.2||||0.918|TWO_SIDED|95.0|-3.65|4.06|||ANCOVA|||Week 52 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 52 were imputed by return-to-baseline multiple imputations approach.||4.06|-3.65|0.918
73868084|NCT05362058|147281386|SUPERIORITY||LS Mean Difference|-0.36||||0.31|TWO_SIDED|95.0|-1.06|0.34|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.34|-1.06|0.310
73868085|NCT05362058|147281386|SUPERIORITY||LS Mean Difference|-0.51||||0.138|TWO_SIDED|95.0|-1.19|0.17|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.17|-1.19|0.138
73868086|NCT05362058|147281387|SUPERIORITY||LS Mean Difference|-13.2||||0.136|TWO_SIDED|95.0|-30.5|4.1|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||4.1|-30.5|0.136
73868087|NCT05362058|147281387|SUPERIORITY||LS Mean Difference|-19.7||||0.026|TWO_SIDED|95.0|-37.0|-2.4|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||-2.4|-37.0|0.026
73868088|NCT05362058|147281388|SUPERIORITY||Relative Rate|1.3||||0.111|TWO_SIDED|95.0|0.94|1.78|||Negative binomial model|||||1.78|0.94|0.111
73868089|NCT05362058|147281389|SUPERIORITY||Relative Rate|1.01||||0.983|TWO_SIDED|95.0|0.53|1.89|||Negative binomial model|||||1.89|0.53|0.983
73868090|NCT05362058|147281390|SUPERIORITY||LS Mean Difference|0.5||||0.025|TWO_SIDED|95.0|0.064|0.94|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||0.94|0.064|0.025
73868091|NCT05362058|147281390|SUPERIORITY||LS Mean Difference|0.056||||0.801|TWO_SIDED|95.0|-0.38|0.5|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||0.50|-0.38|0.801
73868092|NCT05362058|147281391|SUPERIORITY||LS Mean Difference|0.13||||0.374|TWO_SIDED|95.0|-0.15|0.41|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||0.41|-0.15|0.374
73868093|NCT05362058|147281391|SUPERIORITY||LS Mean Difference|0.29||||0.13|TWO_SIDED|95.0|-0.09|0.67|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.67|-0.09|0.130
73868094|NCT05362058|147281391|SUPERIORITY||LS Mean Difference|0.3||||0.162|TWO_SIDED|95.0|-0.12|0.72|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.72|-0.12|0.162
73868095|NCT05362058|147281392|SUPERIORITY||LS Mean Difference|-0.03||||0.594|TWO_SIDED|95.0|-0.15|0.08|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||0.08|-0.15|0.594
73868096|NCT05362058|147281392|SUPERIORITY||LS Mean Difference|0.06||||0.266|TWO_SIDED|95.0|-0.04|0.16|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.16|-0.04|0.266
73941618|NCT01031810|147415103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.56|STANDARD_DEVIATION|10.81||0.012|TWO_SIDED|95.0|3.25|19.86|||paired t-test 2 sided|||Compare the mean differences between baseline (week00) and week12 hamd17 summary scores||19.86|3.25|0.012
73941619|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
73941620|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
73941621|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
73941622|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Inpatient cost comparison||||< 0.001
73941623|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Inpatient cost comparison.||||< 0.001
73868097|NCT05362058|147281392|SUPERIORITY||LS Mean Difference|0.02||||0.791|TWO_SIDED|95.0|-0.1|0.14|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.14|-0.10|0.791
73868098|NCT05362058|147281393|SUPERIORITY||LS Mean Difference|-0.41||||0.757|TWO_SIDED|95.0|-3.0|2.18|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||2.18|-3.00|0.757
73868099|NCT05362058|147281393|SUPERIORITY||LS Mean Difference|-0.93||||0.511|TWO_SIDED|95.0|-3.72|1.85|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||1.85|-3.72|0.511
73974729|NCT01074294|147494954|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.3959|TWO_SIDED|95.0|-0.15|0.38||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||0.38|-0.15|0.3959
73868100|NCT05362058|147281393|SUPERIORITY||LS Mean Difference|-3.39||||0.027|TWO_SIDED|95.0|-6.39|-0.39|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||-0.39|-6.39|0.027
73868101|NCT05362058|147281394|SUPERIORITY||LS Mean Difference|1.66||||0.021|TWO_SIDED|95.0|0.26|3.07|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||3.07|0.26|0.021
73941624|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.||||||0.126|||||||Bang and Tsiatis|||Inpatient cost comparison||||0.126
73941625|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
73941626|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
73941627|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
73941628|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
73868102|NCT05362058|147281394|SUPERIORITY||LS Mean Difference|2.0||||0.006|TWO_SIDED|95.0|0.57|3.44|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||3.44|0.57|0.006
73868103|NCT05362058|147281395|SUPERIORITY||LS Mean Difference|-0.2||||0.638|TWO_SIDED|95.0|-1.03|0.63|||Mixed Models Analysis|||Physical Component Score at Week 26 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.63|-1.03|0.638
73941629|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
73941630|NCT04295005|147415138|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
73941631|NCT04020341|147415171|NON_INFERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the Z-statistic boundary (2.065).|Adjusted Difference in Percent|4.3|||||TWO_SIDED|95.0|-3.6|12.1|||||||Observed Z statistic value for Noninferiority was 3.5554.|12.1|-3.6|
73941632|NCT04020341|147415171|SUPERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.019 p-value boundary.|Adjusted difference of Percent|4.3||||0.1445|TWO_SIDED|95.0|-3.6|12.1|||1-sided p-value for Test of Superiority|||||12.1|-3.6|0.1445
74008547|NCT02374021|147566898|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.05|TWO_SIDED|95.0|-0.17|0.16|||ANCOVA|||||0.16|-0.17|0.05
74089168|NCT03575871|147731441|SUPERIORITY||Difference in LS mean|-0.9||||0.0164|TWO_SIDED|95.0|-1.7|-0.2|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.2|-1.7|0.0164
73868104|NCT05362058|147281395|SUPERIORITY||LS Mean Difference|-0.32||||0.499|TWO_SIDED|95.0|-1.24|0.6|||Mixed Models Analysis|||Mental Component Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.60|-1.24|0.499
73868105|NCT05362058|147281395|SUPERIORITY||LS Mean Difference|0.17||||0.695|TWO_SIDED|95.0|-0.68|1.01|||Mixed Models Analysis|||Physical Component Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||1.01|-0.68|0.695
73868106|NCT05362058|147281395|SUPERIORITY||LS Mean Difference|-0.23||||0.626|TWO_SIDED|95.0|-1.17|0.71|||Mixed Models Analysis|||Mental Component Score at Week 52 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.71|-1.17|0.626
73868107|NCT05362058|147281396|SUPERIORITY||LS Mean Difference|-0.015||||0.128|TWO_SIDED|95.0|-0.034|0.004|||Mixed Models Analysis|||EQ-5D-5L Health State Index Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.004|-0.034|0.128
73941633|NCT04683926|147415207|OTHER||AUC(0-36) Estimate (β1)|1.0227|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
73941634|NCT04683926|147415207|OTHER||AUC(inf) Estimate (β1)|1.0223|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
73941635|NCT04683926|147415207|EQUIVALENCE|Absent food effect will be established if the 90% CI for the ratio of population geometric means between fed and fasted 30 mg doses, based on log-transformed data, is contained in the equivalence limits of 0.80-1.25 for AUC0-inf and Cmax.|AUC(0-inf) fed/fasted ratio|1.09|||||TWO_SIDED|90.0|1.05|1.12||||||Analysis of food effect on desmetramadol in the evaluable population using natural logarithm-transformed PK exposure parameters of desmetramadol enantiomers following administration of 30 mg desmetramadol in the fed and fasted states.||1.12|1.05|
73941636|NCT04683926|147415208|OTHER||Cmax Estimate (β1)|0.9899|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
73941637|NCT04683926|147415208|EQUIVALENCE|Absent food effect will be established if the 90% CI for the ratio of population geometric means between fed and fasted 30 mg doses, based on log-transformed data, is contained in the equivalence limits of 0.80-1.25 for AUC0-inf and Cmax.|Cmax 90% fed/fasted ratio|1.18|||||TWO_SIDED|90.0|1.08|1.28||||||Analysis of food effect on desmetramadol in the evaluable population using natural logarithm-transformed PK exposure parameters of desmetramadol enantiomers following administration of 30 mg desmetramadol in the fed and fasted states.||1.28|1.08|
73941638|NCT00716092|147415220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001||95.0|-28.0|-11.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) was to be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-11.9|-28.0|<0.0001
73941639|NCT00716092|147415221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.1|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001||95.0|12.4|23.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) will be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||23.9|12.4|<0.0001
73941640|NCT00716092|147415222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|4.8||0.0283||95.0|-20.4|-1.2|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-1.2|-20.4|0.0283
73941641|NCT00716092|147415223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.5|STANDARD_ERROR_OF_MEAN|20.3|<|0.0001||95.0|-147.0|-66.0|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-66.0|-147.0|<0.0001
73941642|NCT00716092|147415224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|3.9||0.1274||95.0|-1.7|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||13.8|-1.7|0.1274
73868108|NCT05362058|147281396|SUPERIORITY||LS Mean Difference|-1.11||||0.196|TWO_SIDED|95.0|-2.8|0.58|||Mixed Models Analysis|||EQ VAS Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.58|-2.80|0.196
73868109|NCT05362058|147281396|SUPERIORITY||LS Mean Difference|-0.01||||0.285|TWO_SIDED|95.0|-0.029|0.008|||Mixed Models Analysis|||EQ-5D-5L Health State Index Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.008|-0.029|0.285
73868110|NCT05362058|147281396|SUPERIORITY||LS Mean Difference|-0.35||||0.701|TWO_SIDED|95.0|-2.15|1.44|||Mixed Models Analysis|||EQ VAS Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||1.44|-2.15|0.701
73868111|NCT00286494|147281404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.67|-0.28||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.28|-0.67|<0.001
73868112|NCT00286494|147281404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.8|-0.41||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.41|-0.80|<0.001
74031227|NCT02043301|147615951|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||TWO_SIDED|90.0|86.558|108.926|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||108.926|86.558|
74031228|NCT02043301|147615951|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||TWO_SIDED|90.0|83.359|104.912|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||104.912|83.359|
74031229|NCT02043301|147615952|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||TWO_SIDED|90.0|86.558|108.926|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||108.926|86.558|
74031230|NCT02043301|147615952|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||TWO_SIDED|90.0|83.359|104.912|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||104.912|83.359|
74031231|NCT02043301|147615954|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.51|||||TWO_SIDED|90.0|97.555|107.717|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||107.717|97.555|
74031232|NCT02043301|147615954|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.02|||||TWO_SIDED|90.0|97.131|107.151|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||107.151|97.131|
74031233|NCT02043301|147615955|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||TWO_SIDED|90.0|60.883|102.735|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||102.735|60.883|
74031234|NCT02043301|147615955|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||TWO_SIDED|90.0|70.269|118.248|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||118.248|70.269|
74031235|NCT02043301|147615956|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||TWO_SIDED|90.0|60.883|102.735|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||102.735|60.883|
74031236|NCT02043301|147615956|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||TWO_SIDED|90.0|70.269|118.248|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||118.248|70.269|
74031237|NCT02436577|147615972|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|93.16|||||TWO_SIDED|90.0|85.8|101.15|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.15|85.80|
74031238|NCT02436577|147615972|SUPERIORITY_OR_OTHER||Geometric mean ratio|93.67|||||TWO_SIDED|90.0|87.88|99.84|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.84|87.88|
73868113|NCT00286494|147281405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.36|-0.16||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.16|-0.36|<0.001
73868114|NCT00286494|147281405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|||<|0.001|TWO_SIDED|95.0|-0.41|-0.21||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.21|-0.41|<0.001
73868115|NCT00286494|147281406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.56|-0.27||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.56|<0.001
73868116|NCT00286494|147281406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.69|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.40|-0.69|<0.001
73868117|NCT00286494|147281407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.30|-0.63|<0.001
73868118|NCT00286494|147281407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.75|-0.43||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.43|-0.75|<0.001
73868119|NCT00286494|147281408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||<|0.001|TWO_SIDED|95.0|-0.63|-0.26||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.26|-0.63|<0.001
73868120|NCT00286494|147281408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.76|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.40|-0.76|<0.001
73868121|NCT00286494|147281409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.001|TWO_SIDED|95.0|-0.6|-0.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.22|-0.60|<0.001
73868122|NCT00286494|147281409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.74|-0.36||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.74|<0.001
73868123|NCT00286494|147281410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.4||||0.003|TWO_SIDED|95.0|-18.9|-3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-3.9|-18.9|0.003
73868124|NCT00286494|147281410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-23.0|-8.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.0|-23.0|<0.001
74031239|NCT02436577|147615972|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.79|||||TWO_SIDED|90.0|88.27|106.14|||ANOVA|||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||106.14|88.27|
73868125|NCT00286494|147281411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.2|||<|0.001|TWO_SIDED|95.0|-26.4|-11.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-11.9|-26.4|<0.001
73868126|NCT00286494|147281411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4|||<|0.001|TWO_SIDED|95.0|-26.6|-12.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.3|-26.6|<0.001
74031240|NCT02436577|147615972|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.32|||||TWO_SIDED|90.0|85.04|100.23|||ANOVA|||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||100.23|85.04|
73941643|NCT00716092|147415225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|2.7||0.313||95.0|-2.7|8.2|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||8.2|-2.7|0.3130
73941644|NCT00716092|147415226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|4.3||0.2281||95.0|-3.3|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||13.8|-3.3|0.2281
73941645|NCT00716092|147415227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|STANDARD_ERROR_OF_MEAN|18.6||0.223||95.0|-14.0|59.5|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||59.5|-14.0|0.2230
73941646|NCT00677235|147415237|SUPERIORITY_OR_OTHER|||||||0.449|||||||Fisher Exact|||||||0.449
73941647|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.641|||<|0.001|TWO_SIDED|95.0|1.247|2.159|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=12.514||Age of mother bearing, \<=30 years vs \>30 years||2.159|1.247|<0.001
73941648|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.793||||0.06|TWO_SIDED|95.0|0.622|1.01|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.529||Household register, local vs nonlocal||1.010|0.622|0.060
73941649|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.369||||0.006|TWO_SIDED|95.0|1.672|32.479|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.524||Mother's education level, illiteracy vs postgraduate or above||32.479|1.672|0.006
73941650|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.443||||0.102|TWO_SIDED|95.0|1.001|11.843|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.671||Mother's education level, elementary school vs postgraduate or above||11.843|1.001|0.102
73974730|NCT01074294|147494954|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6763|TWO_SIDED|95.0|-0.23|0.35||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||0.35|-0.23|0.6763
73974731|NCT01074294|147494955|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.4089|TWO_SIDED|95.0|-0.37|0.91||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.91|-0.37|0.4089
73941651|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.064||||0.159|TWO_SIDED|95.0|0.933|10.067|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.984||Mother's education level, junior middle school vs postgraduate or above||10.067|0.933|0.159
73941652|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.321||||0.662|TWO_SIDED|95.0|0.71|7.589|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.191||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||7.589|0.710|0.662
73941653|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.306|||<|0.001|TWO_SIDED|95.0|0.399|4.277|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=13.525||Mother's education level, college/university vs postgraduate or above||4.277|0.399|<0.001
73941654|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.217||||0.043|TWO_SIDED|95.0|0.719|6.831|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.095||Family monthly income per capita, \<=600 RMB vs \>=10000 RMB||6.831|0.719|0.043
73941655|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.089||||0.01|TWO_SIDED|95.0|0.739|5.906|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=6.549||Family monthly income per capita, 600 to 1999 RMB vs \>=10000 RMB||5.906|0.739|0.010
73941656|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.983||||0.021|TWO_SIDED|95.0|0.704|5.583|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.313||Family monthly income per capita, 2000 to 4999 RMB vs \>=10000 RMB||5.583|0.704|0.021
73941657|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.364|TWO_SIDED|95.0|0.344|3.267|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.824||Family monthly income per capita, 5000 to 7999 RMB vs \>=10000 RMB||3.267|0.344|0.364
73941658|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.175|TWO_SIDED|95.0|0.1|3.347|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.838||||3.347|0.100|0.175
73941659|NCT00952367|147415254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.516|||<|0.001|TWO_SIDED|95.0|0.4|0.666|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=25.960||Whether have brothers or sisters, no vs yes||0.666|0.400|<0.001
73941660|NCT00952367|147415255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.255||||0.057|TWO_SIDED|95.0|0.062|1.044|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.610||Birth information, preterm birth vs full-term birth||1.044|0.062|0.057
73941661|NCT00952367|147415255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.666||||0.04|TWO_SIDED|95.0|0.451|0.981|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.228||Household register, local vs nonlocal||0.981|0.451|0.040
73941662|NCT00952367|147415255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.182||||0.044|TWO_SIDED|95.0|0.758|1.844|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.074||Feeding manners within 6 months, pure breast feeding vs pure formula milk feeding||1.844|0.758|0.044
74031241|NCT02436577|147615973|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|97.76|||||TWO_SIDED|90.0|94.46|101.18|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.18|94.46|
73868127|NCT00286494|147281412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.6|||<|0.001|TWO_SIDED|95.0|-27.5|-13.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.6|-27.5|<0.001
73868128|NCT00286494|147281412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.0|||<|0.001|TWO_SIDED|95.0|-29.9|-16.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-16.0|-29.9|<0.001
73868129|NCT00286494|147281413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.5|||<|0.001|TWO_SIDED|95.0|-24.4|-8.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.7|-24.4|<0.001
73868130|NCT00286494|147281413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.1|||<|0.001|TWO_SIDED|95.0|-28.9|-13.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.3|-28.9|<0.001
73868131|NCT00286494|147281414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.011|TWO_SIDED|95.0|-18.5|-2.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.4|-18.5|0.011
73868132|NCT00286494|147281414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|||<|0.001|TWO_SIDED|95.0|-24.3|-8.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.3|-24.3|<0.001
73868133|NCT00286494|147281415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0||||0.029|TWO_SIDED|95.0|-18.9|-1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.0|-18.9|0.029
73868134|NCT00286494|147281415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4||||0.002|TWO_SIDED|95.0|-23.3|-5.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.5|-23.3|0.002
73868135|NCT00286494|147281416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||<|0.001|TWO_SIDED|95.0|-24.2|-6.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.9|-24.2|<0.001
73868136|NCT00286494|147281416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-23.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.7|-23.8|<0.001
73868137|NCT00286494|147281417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9||||0.003|TWO_SIDED|95.0|-23.1|-4.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-4.8|-23.1|0.003
73868138|NCT00286494|147281417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.1||||0.003|TWO_SIDED|95.0|-23.3|-5.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.0|-23.3|0.003
73868139|NCT00286494|147281418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.271|||<|0.001|TWO_SIDED|95.0|0.147|0.499||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.499|0.147|<0.001
73941663|NCT00952367|147415255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.707||||0.038|TWO_SIDED|95.0|0.42|1.191|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.316||Feeding manners within 6 months, mixed feeding vs pure formula milk feeding||1.191|0.420|0.038
73941664|NCT00952367|147415255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|92.229||||0.006|TWO_SIDED|95.0|3.993|2130.5|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.438||Father's education level, illiteracy vs postgraduate or above||2130.500|3.993|0.006
73941665|NCT00952367|147415255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.671||||0.778|TWO_SIDED|95.0|0.537|40.608|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.079||Father's education level, elementary school vs postgraduate or above||40.608|0.537|0.778
73941666|NCT00952367|147415255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.83||||0.756|TWO_SIDED|95.0|0.649|35.956|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.096||Father's education level, junior high school vs postgraduate or above||35.956|0.649|0.756
73941667|NCT00952367|147415255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.513||||0.179|TWO_SIDED|95.0|0.474|26.03|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.807||Father's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||26.030|0.474|0.179
73868140|NCT00286494|147281418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.235|||<|0.001|TWO_SIDED|95.0|0.126|0.438||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.438|0.126|<0.001
73868141|NCT00286494|147281419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.628||||0.266|TWO_SIDED|95.0|0.277|1.425||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.425|0.277|0.266
73868142|NCT00286494|147281419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.658||||0.315|TWO_SIDED|95.0|0.292|1.487|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.487|0.292|0.315
73868143|NCT00286494|147281420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4||||0.003|TWO_SIDED|95.0|-10.6|-2.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.1|-10.6|0.003
73868144|NCT00286494|147281420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.023|TWO_SIDED|95.0|-9.1|-0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.7|-9.1|0.023
73868145|NCT00286494|147281421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.043|TWO_SIDED|95.0|-8.3|-0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.1|-8.3|0.043
73868146|NCT00286494|147281421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.489|TWO_SIDED|95.0|-5.5|2.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.6|-5.5|0.489
73974732|NCT01074294|147494956|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2331|TWO_SIDED|95.0|-0.8|0.2||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||Week 11 data is included here. The planned sample size of 225 participants (150 in brexipiprazole arm and 75 in the placebo arm) yielded at least 80% power to detect effects at a 2-tailed significance level of 0.05 using a two-sided z-test.|||0.20|-0.80|0.2331
73974733|NCT01074294|147494957|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.067|TWO_SIDED|95.0|-0.01|0.0||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.00|-0.01|0.0670
73974734|NCT01074294|147494958|SUPERIORITY||Mean Difference (Final Values)|-14.3||||0.0849|TWO_SIDED|95.0|-30.5|1.98||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.98|-30.5|0.0849
73974735|NCT01074294|147494959|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.7663|TWO_SIDED|95.0|-3.52|2.6||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||2.60|-3.52|0.7663
73974736|NCT01074294|147494960|SUPERIORITY||Mean Difference (Final Values)|17.51||||0.0298|TWO_SIDED|95.0|1.73|33.29||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||33.29|1.73|0.0298
73868147|NCT00286494|147281422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.068|TWO_SIDED|95.0|-8.8|0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.3|-8.8|0.068
73941668|NCT00952367|147415255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.029||||0.077|TWO_SIDED|95.0|0.412|22.292|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.131||Father's education level, college/university vs postgraduate or above||22.292|0.412|0.077
73941669|NCT00952367|147415255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.984||||0.056|TWO_SIDED|95.0|0.968|1.0|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.648||Living space per capita, continuous variables||1.000|0.968|0.056
73941670|NCT00952367|147415255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.729||||0.064|TWO_SIDED|95.0|0.522|1.018|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.432||Vaccination history of Hib, no vs yes||1.018|0.522|0.064
73941671|NCT00952367|147415256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.438||||0.019|TWO_SIDED|95.0|0.221|0.871|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.538||Birth information, preterm birth vs full-term birth||0.871|0.221|0.019
73868148|NCT00286494|147281422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.056|TWO_SIDED|95.0|-8.9|0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.1|-8.9|0.056
73868149|NCT00286494|147281423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-4.9|4.2||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.2|-4.9|0.884
73868150|NCT00286494|147281423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-4.5|4.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.5|-4.5|0.993
73868151|NCT00286494|147281424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.009|TWO_SIDED|95.0|-9.4|-1.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.3|-9.4|0.009
73868152|NCT00286494|147281424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.143|TWO_SIDED|95.0|-7.0|1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.0|-7.0|0.143
73868153|NCT00286494|147281425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.08|TWO_SIDED|95.0|-8.6|0.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.5|-8.6|0.080
73868154|NCT00286494|147281425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.782|TWO_SIDED|95.0|-5.2|3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.9|-5.2|0.782
73868155|NCT00286494|147281426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.249|TWO_SIDED|95.0|-2.68|0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.70|-2.68|0.249
73868156|NCT00286494|147281426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.303|TWO_SIDED|95.0|-2.56|0.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.80|-2.56|0.303
73868157|NCT00286494|147281427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.478|TWO_SIDED|95.0|-2.46|1.15||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.15|-2.46|0.478
73941672|NCT00952367|147415256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.546|||<|0.001|TWO_SIDED|95.0|0.423|0.703|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=21.938||Household register, local vs nonlocal||0.703|0.423|<0.001
73868158|NCT00286494|147281427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.674|TWO_SIDED|95.0|-1.41|2.17||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.17|-1.41|0.674
73868159|NCT00286494|147281428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.743|TWO_SIDED|95.0|-2.18|3.06||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.06|-2.18|0.743
73868160|NCT00286494|147281428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.662|TWO_SIDED|95.0|-3.18|2.02||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.02|-3.18|0.662
73868161|NCT00286494|147281429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75||||0.39|TWO_SIDED|95.0|-0.96|2.45||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.45|-0.96|0.390
73868162|NCT00286494|147281429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.423|TWO_SIDED|95.0|-1.0|2.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.38|-1.00|0.423
73868163|NCT00286494|147281430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.807|TWO_SIDED|95.0|-1.87|1.46||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.46|-1.87|0.807
73868164|NCT00286494|147281430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.867|TWO_SIDED|95.0|-1.79|1.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.51|-1.79|0.867
73868165|NCT00286494|147281431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.483|TWO_SIDED|95.0|-1.1|2.33||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.33|-1.10|0.483
73868166|NCT00286494|147281431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.352|TWO_SIDED|95.0|-0.89|2.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.51|-0.89|0.352
73868167|NCT00286494|147281432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057||||0.001|TWO_SIDED|95.0|-0.092|-0.022||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.022|-0.092|0.001
73941673|NCT00952367|147415256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.137||||0.559|TWO_SIDED|95.0|0.473|9.652|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.341||Mother's education level, illiteracy vs graduate or above||9.652|0.473|0.559
73941674|NCT00952367|147415256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.793||||0.626|TWO_SIDED|95.0|0.596|5.394|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.238||Mother's education level, elementary school vs graduate or above||5.394|0.596|0.626
73941675|NCT00952367|147415256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.972||||0.193|TWO_SIDED|95.0|0.699|5.562|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.691||Mother's education level, junior middle school vs graduate or above||5.562|0.699|0.193
74031242|NCT02436577|147615973|SUPERIORITY_OR_OTHER||Geometric Mean ratio|96.38|||||TWO_SIDED|90.0|93.24|99.63|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.63|93.24|
74031243|NCT02436577|147615973|SUPERIORITY_OR_OTHER||Geometric mean ratio|98.43|||||TWO_SIDED|90.0|94.75|102.25|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||102.25|94.75|
73868168|NCT00286494|147281432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059||||0.001|TWO_SIDED|95.0|-0.093|-0.024||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.024|-0.093|0.001
73868169|NCT00286494|147281433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049||||0.006|TWO_SIDED|95.0|-0.084|-0.014||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.014|-0.084|0.006
73868170|NCT00286494|147281433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.004|TWO_SIDED|95.0|-0.086|-0.016||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.016|-0.086|0.004
73941676|NCT00952367|147415256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.907||||0.298|TWO_SIDED|95.0|0.679|5.353|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.081||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||5.353|0.679|0.298
73941677|NCT00952367|147415256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.233||||0.122|TWO_SIDED|95.0|0.439|3.464|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.395||Mother's education level, college/university vs postgraduate or above||3.464|0.439|0.122
74031244|NCT02436577|147615973|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.15|||||TWO_SIDED|90.0|91.59|98.85|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||98.85|91.59|
74031245|NCT02436577|147615974|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|97.75|||||TWO_SIDED|90.0|94.4|101.21|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.21|94.40|
73868171|NCT00286494|147281434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.05|TWO_SIDED|95.0|-0.092|0.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.000|-0.092|0.050
73868172|NCT00286494|147281434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057||||0.014|TWO_SIDED|95.0|-0.102|-0.012||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.012|-0.102|0.014
73868173|NCT00286494|147281435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027||||0.144|TWO_SIDED|95.0|-0.064|0.009||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.064|0.144
73868174|NCT00286494|147281435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.105|TWO_SIDED|95.0|-0.067|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.006|-0.067|0.105
73868175|NCT00286494|147281436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059||||0.004|TWO_SIDED|95.0|-0.1|-0.019||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.019|-0.100|0.004
73868176|NCT00286494|147281436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.012|TWO_SIDED|95.0|-0.092|-0.011||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.011|-0.092|0.012
73868177|NCT00286494|147281437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.028|TWO_SIDED|95.0|-0.095|-0.005||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.005|-0.095|0.028
73868178|NCT00286494|147281437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038||||0.093|TWO_SIDED|95.0|-0.082|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.006|-0.082|0.093
73868179|NCT00286494|147281438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.928|TWO_SIDED|95.0|-0.28|0.255||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.255|-0.280|0.928
73868180|NCT00286494|147281438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056||||0.683|TWO_SIDED|95.0|-0.212|0.324||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.324|-0.212|0.683
73868181|NCT00286494|147281439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.967|TWO_SIDED|95.0|-0.277|0.265||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.265|-0.277|0.967
73868182|NCT00286494|147281439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135||||0.327|TWO_SIDED|95.0|-0.135|0.405||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.405|-0.135|0.327
73868183|NCT00286494|147281440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068||||0.649|TWO_SIDED|95.0|-0.363|0.226||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.226|-0.363|0.649
73868184|NCT00286494|147281440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.735|TWO_SIDED|95.0|-0.344|0.243||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.243|-0.344|0.735
73868185|NCT00286494|147281441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.114|TWO_SIDED|95.0|-0.053|0.492||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.492|-0.053|0.114
73941678|NCT00952367|147415256|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.666||||0.001|TWO_SIDED|95.0|0.52|0.855|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=10.233||Whether have brothers or sisters, no vs yes||0.855|0.520|0.001
73868186|NCT00286494|147281441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.086|TWO_SIDED|95.0|-0.033|0.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.510|-0.033|0.086
73868187|NCT00286494|147281442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.835|TWO_SIDED|95.0|-0.221|0.273||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.273|-0.221|0.835
73868188|NCT00286494|147281442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131||||0.296|TWO_SIDED|95.0|-0.115|0.378||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.378|-0.115|0.296
73868189|NCT00286494|147281443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123||||0.349|TWO_SIDED|95.0|-0.134|0.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.380|-0.134|0.349
73868190|NCT00286494|147281443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223||||0.089|TWO_SIDED|95.0|-0.034|0.479||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.479|-0.034|0.089
73868191|NCT00286494|147281444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.815||||0.003|TWO_SIDED|95.0|1.736|13.358|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||13.358|1.736|0.003
73868192|NCT00286494|147281444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.533|||<|0.001|TWO_SIDED|95.0|2.017|15.176|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||15.176|2.017|<0.001
73868193|NCT00286494|147281445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.903||||0.029|TWO_SIDED|95.0|1.067|3.393|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.393|1.067|0.029
73868194|NCT00286494|147281445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.301||||0.005|TWO_SIDED|95.0|1.291|4.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regiment \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.100|1.291|0.005
73941679|NCT04570436|147415263|SUPERIORITY||Mean Difference (Final Values)|30.9|STANDARD_ERROR_OF_MEAN|2.85|<|0.0001|ONE_SIDED|95.0|26.2||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of diazepam, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 = 15"|||26.2|<0.0001
73868195|NCT00286494|147281446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.783|||<|0.001|TWO_SIDED|95.0|1.547|5.005|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.005|1.547|<0.001
73868196|NCT00286494|147281446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.917|||<|0.001|TWO_SIDED|95.0|2.147|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.146|2.147|<0.001
73868197|NCT00286494|147281447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.134|||<|0.001|TWO_SIDED|95.0|2.392|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.146|2.392|<0.001
73868198|NCT00286494|147281447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.247|||<|0.001|TWO_SIDED|95.0|3.027|9.094|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||9.094|3.027|<0.001
73868199|NCT00286494|147281448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.001|TWO_SIDED|95.0|1.789|7.532|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.532|1.789|<0.001
73868200|NCT00286494|147281448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.693|||<|0.001|TWO_SIDED|95.0|2.303|9.56|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||9.560|2.303|<0.001
73868201|NCT00286494|147281449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.8||||0.015|TWO_SIDED|95.0|1.3|11.107|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.107|1.300|0.015
73868202|NCT00286494|147281449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.196||||0.002|TWO_SIDED|95.0|1.806|14.95|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||14.950|1.806|0.002
73868203|NCT00286494|147281450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.959||||0.364|TWO_SIDED|95.0|0.459|8.362|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||8.362|0.459|0.364
73868204|NCT00286494|147281450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.849||||0.146|TWO_SIDED|95.0|0.696|11.672|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.672|0.696|0.146
73868205|NCT00286494|147281451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.718|TWO_SIDED|95.0|-0.45|0.65||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose,baseline value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.65|-0.45|0.718
73868206|NCT00286494|147281451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.906|TWO_SIDED|95.0|-0.52|0.58||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.58|-0.52|0.906
73868207|NCT00286494|147281452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.672|TWO_SIDED|95.0|-0.5|0.78||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.78|-0.50|0.672
73868208|NCT00286494|147281452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.922|TWO_SIDED|95.0|-0.61|0.67||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.67|-0.61|0.922
73868209|NCT00286494|147281453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.607|TWO_SIDED|95.0|-0.56|0.96||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.96|-0.56|0.607
73868210|NCT00286494|147281453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.985|TWO_SIDED|95.0|-0.77|0.76||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.76|-0.77|0.985
74031246|NCT02436577|147615974|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.5|||||TWO_SIDED|90.0|93.31|99.8|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.80|93.31|
73868211|NCT00286494|147281454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.294|TWO_SIDED|95.0|-0.37|1.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.22|-0.37|0.294
73868212|NCT00286494|147281454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9|TWO_SIDED|95.0|-0.74|0.84||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.84|-0.74|0.900
73868213|NCT02524158|147281598|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.340
73868214|NCT02524158|147281599|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||0.003
73868215|NCT02524158|147281600|SUPERIORITY|||||||0.005||||||The a priori specified threshold is p \< 0.05|Mixed Models Analysis|||||||0.005
73868216|NCT02524158|147281601|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
73868217|NCT02524158|147281602|SUPERIORITY|||||||0.044||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.044
73868218|NCT02524158|147281603|SUPERIORITY||||||<|0.01|||||||ANCOVA|||||||<0.01
73868219|NCT02524158|147281604|SUPERIORITY|||||||0.01||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.010
73868220|NCT02524158|147281605|SUPERIORITY|||||||0.66|||||||ANCOVA|||||||0.66
73868221|NCT02524158|147281606|SUPERIORITY||||||<|0.1|||||||Mixed Models Analysis|||||||<0.10
73868222|NCT02524158|147281607|SUPERIORITY|||||||0.202|||||||ANCOVA|||||||0.202
73868223|NCT02524158|147281608|SUPERIORITY|||||||0.369|||||||ANCOVA|||||||0.369
73868224|NCT02524158|147281609|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||0.50
73868225|NCT02524158|147281610|SUPERIORITY|||||||0.067|||||||ANCOVA|||||||0.067
73868226|NCT02524158|147281612|SUPERIORITY|||||||0.071|||||||ANCOVA|||||||0.071
74031247|NCT02436577|147615974|SUPERIORITY_OR_OTHER||Geometric mean ratio|98.46|||||TWO_SIDED|90.0|94.85|102.2|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||102.20|94.85|
73868227|NCT02524158|147281613|SUPERIORITY|||||||0.92|||||||ANCOVA|||||||0.92
73868228|NCT02524158|147281614|SUPERIORITY|||||||0.036||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.036
73868229|NCT02524158|147281615|SUPERIORITY|||||||0.071|||||||ANCOVA|||||||0.071
73868230|NCT04164732|147281627|SUPERIORITY||Median Difference (Net)|0.61||||0.5506|TWO_SIDED|80.0|-0.71|1.94|||longitudinal mixed effects (MMRM) model|||||1.94|-0.71|0.5506
73868231|NCT04302545|147281628|OTHER|Other Primary outcomes were the extent of injury, operative time, blood loss and proportion of subjects receiving a blood transfusion. Postoperatively, subjects were assessed for secondary outcomes of UTI, micturition problems, and fistula formation during the hospital stay and for the next 3 months. Postoperative micturition problems were feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence.|Odds Ratio (OR)|-0.178|||<|0.0001|TWO_SIDED|95.0|-0.261|-0.094||The threshold for statistical significance was \<.05.|Regression, Linear|||"Null Hypothesis: During the cesarean section of women with adhesions of the previous cesarean section that obscure the bladder, the bladder injury rate is not significantly decreased in cystoinflation group compared to the control.~In this study, the bladder injury rate was seven times lesser in cystoinflation group compared to the control, thereby strongly supporting our hypothesis. The power of the study for bladder injury was 0.988, calculated with statistical software G'Power version 3.1."||-.094|-.261|<.0001
73868232|NCT04302545|147281629|OTHER||Odds Ratio (OR)|-211.776|||<|0.0001|TWO_SIDED|95.0|-290.7|-132.84|||Regression, Linear|||||-132.84|-290.70|<0.0001
73868233|NCT04302545|147281630|OTHER||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|-3.634|3.634|||Regression, Linear|||Null Hypothsis:Cystoinflation is ineffective to prevent bladder injury in adhesions of previous C-section.The cystoinflation was to be cosidered ineffective if proportion of bladder injury in study group was less than %0% of the control.The power of the study for bladder injury prevention was.988,calculated with statistical software G'Power version3.1.||3.634|-3.634|1
73868234|NCT04302545|147281631|OTHER||Odds Ratio (OR)|-1.093||||0.001|TWO_SIDED|95.0|-1.708|-0.479|||Regression, Linear|||||-.479|-1.708|.001
73974737|NCT01074294|147494961|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.2563|TWO_SIDED|95.0|-0.05|0.01||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.01|-0.05|0.2563
73974738|NCT01074294|147494962|SUPERIORITY||Mean Difference (Final Values)|-5.67||||0.6644|TWO_SIDED|95.0|-31.4|20.06||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||20.06|-31.4|0.6644
73868235|NCT04302545|147281632|OTHER||Odds Ratio (OR)|-0.15|||<|0.0001|TWO_SIDED|95.0|-0.226|-0.073|||Regression, Linear|||||-0.073|-0.226|<0.0001
73974739|NCT01074294|147494963|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.8418|TWO_SIDED|95.0|-0.56|0.45||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.45|-0.56|0.8418
73868236|NCT04302545|147281633|OTHER||Odds Ratio (OR)|-0.103||||0.003|TWO_SIDED|95.0|-0.171|-0.035|||Regression, Linear|||||-0.035|-0.171|0.003
73868237|NCT04302545|147281634|OTHER||Odds Ratio (OR)|0.654||||0.336|TWO_SIDED|95.0|-0.682|1.991|||Regression, Linear|||||1.991|-0.682|.336
73868238|NCT04302545|147281635|OTHER||Odds Ratio (OR)|-0.393||||0.021|TWO_SIDED|95.0|-0.725|-0.06|||Regression, Linear|||||-0.06|-0.725|.021
73868239|NCT04302545|147281636|OTHER||Odds Ratio (OR)|-1.89|||<|0.0001|TWO_SIDED|95.0|-2.813|-0.963|||Regression, Linear|||||-0.963|-2.813|<0.0001
73868240|NCT04302545|147281637|OTHER||Odds Ratio (OR)|-1.318|||<|0.0001|TWO_SIDED|95.0|-2.021|-0.614|||Regression, Linear|||||-0.614|-2.021|<.0001
73868241|NCT04302545|147281639|OTHER||Odds Ratio (OR)|-0.065||||0.003|TWO_SIDED|95.0|-0.108|-0.023|||Regression, Linear|||||-.023|-.108|.003
73868242|NCT01457846|147281683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.57||||0.9581|TWO_SIDED|80.0|1.12|2.21||1-sided|Regression, Cox|||||2.21|1.12|0.9581
73868243|NCT01457846|147281684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.8156|TWO_SIDED|80.0|0.89|1.95||1-sided|Regression, Cox|||||1.95|0.89|0.8156
73868244|NCT01457846|147281685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.997|TWO_SIDED|80.0|0.02|0.35||1-sided|Regression, Logistic|||||0.35|0.02|0.9970
73868245|NCT02161757|147281688|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.93||||0.5859|TWO_SIDED|95.0|0.72|1.21|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q2W vs placebo.||1.21|0.72|0.5859
73868246|NCT02161757|147281688|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.9||||0.4406|TWO_SIDED|95.0|0.7|1.17|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q4W vs placebo.||1.17|0.70|0.4406
73868247|NCT02161757|147281688|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|7.01||||0.5859|TWO_SIDED|95.0|-20.76|28.39|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q2W vs placebo.||28.39|-20.76|0.5859
73868248|NCT02161757|147281688|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|9.76||||0.4406|TWO_SIDED|95.0|-17.16|30.5|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q4W vs placebo.||30.50|-17.16|0.4406
73868249|NCT02161757|147281689|SUPERIORITY||Least square (LS) Mean difference|6.03|||||TWO_SIDED|95.0|2.34|9.73|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."||9.73|2.34|
73868250|NCT02161757|147281689|SUPERIORITY||LS Mean difference|2.1|||||TWO_SIDED|95.0|-1.58|5.77|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."||5.77|-1.58|
73868251|NCT02161757|147281690|SUPERIORITY||LS Mean difference|-0.09|||||TWO_SIDED|95.0|-0.23|0.04|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||0.04|-0.23|
73868252|NCT02161757|147281690|SUPERIORITY||LS Mean difference|-0.02|||||TWO_SIDED|95.0|-0.15|0.12|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.12|-0.15|
73868253|NCT02161757|147281691|SUPERIORITY||LS Mean difference|0.15|||||TWO_SIDED|95.0|-0.01|0.31|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||0.31|-0.01|
73868254|NCT02161757|147281691|SUPERIORITY||LS Mean difference|0.12|||||TWO_SIDED|95.0|-0.03|0.28|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.28|-0.03|
73868255|NCT02161757|147281692|SUPERIORITY||LS Mean difference|-0.16|||||TWO_SIDED|95.0|-0.29|-0.02|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||-0.02|-0.29|
73868256|NCT02161757|147281692|SUPERIORITY||LS Mean difference|-0.12|||||TWO_SIDED|95.0|-0.26|0.01|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.01|-0.26|
73868257|NCT02161757|147281693|SUPERIORITY||Rate ratio|0.54||||0.0369|TWO_SIDED|95.0|0.3|0.96|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q2W vs placebo.||0.96|0.30|0.0369
73868258|NCT02161757|147281693|SUPERIORITY||Rate ratio|0.78||||0.3603|TWO_SIDED|95.0|0.46|1.33|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q4W vs placebo.||1.33|0.46|0.3603
73974740|NCT01074294|147494964|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.2513|TWO_SIDED|95.0|-0.69|0.18||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.18|-0.69|0.2513
73974741|NCT01074294|147494965|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.7037|TWO_SIDED|95.0|-0.48|0.71||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.71|-0.48|0.7037
73868259|NCT02161757|147281695|SUPERIORITY||LS Mean difference|-0.11|||||TWO_SIDED|95.0|-0.51|0.29|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.29|-0.51|
73868260|NCT02161757|147281695|SUPERIORITY||LS Mean difference|-0.16|||||TWO_SIDED|95.0|-0.56|0.24|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q4W vs placebo. REML based repeated measures analysis.||0.24|-0.56|
73868261|NCT02161757|147281696|SUPERIORITY||LS Mean difference|6.25|||||TWO_SIDED|95.0|-3.53|16.03|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||16.03|-3.53|
73941680|NCT04570436|147415263|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|2.84||0.3581|ONE_SIDED|95.0||14.7|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||14.7||0.3581
73941681|NCT04570436|147415263|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|9.5|STANDARD_ERROR_OF_MEAN|2.85||0.3051|ONE_SIDED|95.0||14.3|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||14.3||0.3051
73941682|NCT04570436|147415263|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|2.83||0.2179|ONE_SIDED|95.0||13.5|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||13.5||0.2179
73941683|NCT04570436|147415263|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|ONE_SIDED|95.0|16.3||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||16.3|<0.0001
73941684|NCT04570436|147415263|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|21.4|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|ONE_SIDED|95.0|16.7||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||16.7|<0.0001
73941685|NCT04570436|147415263|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|22.1|STANDARD_ERROR_OF_MEAN|2.85|<|0.0001|ONE_SIDED|95.0|17.4||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||17.4|<0.0001
73941686|NCT04570436|147415265|OTHER||Mean Difference (Final Values)|325.8|STANDARD_ERROR_OF_MEAN|113.38||0.0023|ONE_SIDED|90.0|138.2||||Mixed Models Analysis||||||138.2|0.0023
73941687|NCT04570436|147415265|OTHER||Mean Difference (Final Values)|140.5|STANDARD_ERROR_OF_MEAN|113.01||0.2157|TWO_SIDED|90.0|-82.7|363.7|||Mixed Models Analysis|||||363.7|-82.7|0.2157
73941688|NCT04570436|147415265|OTHER||Mean Difference (Final Values)|155.4|STANDARD_ERROR_OF_MEAN|113.25||0.172|TWO_SIDED|90.0|-68.3|379.1|||Mixed Models Analysis|||||379.1|-68.3|0.1720
73974742|NCT01074294|147494966|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.7572|TWO_SIDED|95.0|-0.17|0.23||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||0.23|-0.17|0.7572
73941689|NCT04570436|147415265|OTHER||Mean Difference (Final Values)|212.2|STANDARD_ERROR_OF_MEAN|113.01||0.0622|TWO_SIDED|90.0|-11.0|435.5|||Mixed Models Analysis|||||435.5|-11.0|0.0622
73941690|NCT04570436|147415265|OTHER||Mean Difference (Final Values)|-185.0|STANDARD_ERROR_OF_MEAN|113.04||0.1031|TWO_SIDED|90.0|-409.0|37.94|||Mixed Models Analysis|||||37.94|-409|0.1031
73941691|NCT04570436|147415265|OTHER||Mean Difference (Final Values)|-170.0|STANDARD_ERROR_OF_MEAN|112.97||0.1334|TWO_SIDED|90.0|-394.0|52.71|||Mixed Models Analysis|||||52.71|-394|0.1334
73941692|NCT04570436|147415265|OTHER||Mean Difference (Final Values)|-114.0|STANDARD_ERROR_OF_MEAN|113.59||0.3189|TWO_SIDED|90.0|-338.0|110.8|||Mixed Models Analysis|||||110.8|-338|0.3189
73941693|NCT04570436|147415266|OTHER||Mean Difference (Final Values)|55.77|STANDARD_ERROR_OF_MEAN|5.362|<|0.0001|ONE_SIDED|90.0|46.89||||Mixed Models Analysis||||||46.89|<0.0001
73941694|NCT04570436|147415266|OTHER||Mean Difference (Final Values)|17.18|STANDARD_ERROR_OF_MEAN|5.348||0.0016|TWO_SIDED|90.0|6.61|27.74|||Mixed Models Analysis|||||27.74|6.61|0.0016
73941695|NCT04570436|147415266|OTHER||Mean Difference (Final Values)|21.38|STANDARD_ERROR_OF_MEAN|5.36||0.0001|TWO_SIDED|90.0|10.79|31.96|||Mixed Models Analysis|||||31.96|10.79|0.0001
73974743|NCT01074294|147494966|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.6132|TWO_SIDED|95.0|-0.28|0.17||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||0.17|-0.28|0.6132
73941696|NCT04570436|147415266|OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|5.352|<|0.0001|TWO_SIDED|90.0|11.92|33.07|||Mixed Models Analysis|||||33.07|11.92|<0.0001
73941697|NCT04570436|147415266|OTHER||Mean Difference (Final Values)|-38.6|STANDARD_ERROR_OF_MEAN|5.312|<|0.0001|TWO_SIDED|90.0|-49.1|-28.1|||Mixed Models Analysis|||||-28.1|-49.1|<0.0001
73941698|NCT04570436|147415266|OTHER||Mean Difference (Final Values)|-34.4|STANDARD_ERROR_OF_MEAN|5.308|<|0.0001|TWO_SIDED|90.0|-44.9|-23.9|||Mixed Models Analysis|||||-23.9|-44.9|<0.0001
73941699|NCT04570436|147415266|OTHER||Mean Difference (Final Values)|-33.3|STANDARD_ERROR_OF_MEAN|5.337|<|0.0001|TWO_SIDED|90.0|-43.8|-22.7|||Mixed Models Analysis|||||-22.7|-43.8|<0.0001
73941700|NCT04570436|147415268|OTHER||Mean Difference (Final Values)|234.9|STANDARD_ERROR_OF_MEAN|38.174|<|0.0001|ONE_SIDED|90.0|171.7||||Mixed Models Analysis||||||171.7|<0.0001
73941701|NCT04570436|147415268|OTHER||Mean Difference (Final Values)|66.3|STANDARD_ERROR_OF_MEAN|38.048||0.0834|TWO_SIDED|90.0|-8.86|141.5|||Mixed Models Analysis|||||141.5|-8.86|0.0834
73941702|NCT04570436|147415268|OTHER||Mean Difference (Final Values)|99.06|STANDARD_ERROR_OF_MEAN|38.128||0.0103|TWO_SIDED|90.0|23.75|174.4|||Mixed Models Analysis|||||174.4|23.75|0.0103
73941703|NCT04570436|147415268|OTHER||Mean Difference (Final Values)|97.2|STANDARD_ERROR_OF_MEAN|38.048||0.0116|TWO_SIDED|90.0|22.05|172.4|||Mixed Models Analysis|||||172.4|22.05|0.0116
73941704|NCT04570436|147415268|OTHER||Mean Difference (Final Values)|-169.0|STANDARD_ERROR_OF_MEAN|38.06|<|0.0001|TWO_SIDED|90.0|-244.0|-93.4|||Mixed Models Analysis|||||-93.4|-244|<0.0001
73941705|NCT04570436|147415268|OTHER||Mean Difference (Final Values)|-136.0|STANDARD_ERROR_OF_MEAN|38.036||0.0005|TWO_SIDED|90.0|-211.0|-60.7|||Mixed Models Analysis|||||-60.7|-211|0.0005
73941706|NCT04570436|147415268|OTHER||Mean Difference (Final Values)|-138.0|STANDARD_ERROR_OF_MEAN|38.243||0.0004|TWO_SIDED|90.0|-213.0|-62.2|||Mixed Models Analysis|||||-62.2|-213|0.0004
73974744|NCT01074294|147494966|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9312|TWO_SIDED|95.0|-0.25|0.27||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||0.27|-0.25|0.9312
73974745|NCT01074294|147494966|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.8073|TWO_SIDED|95.0|-0.3|0.24||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||0.24|-0.30|0.8073
73974746|NCT01074294|147494966|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9168|TWO_SIDED|95.0|-0.26|0.29||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||0.29|-0.26|0.9168
73974747|NCT01074294|147494966|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.7432|TWO_SIDED|95.0|-0.34|0.25||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||0.25|-0.34|0.7432
73974748|NCT01074294|147494967|SUPERIORITY||Risk Ratio (RR)|1.2||||0.6014|TWO_SIDED|95.0|0.6|2.42||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.42|0.60|0.6014
73974749|NCT01074294|147494967|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9225|TWO_SIDED|95.0|0.64|1.63||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||1.63|0.64|0.9225
73974750|NCT01074294|147494967|SUPERIORITY||Risk Ratio (RR)|0.86||||0.4803|TWO_SIDED|95.0|0.58|1.3||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.30|0.58|0.4803
73974751|NCT01074294|147494967|SUPERIORITY||Risk Ratio (RR)|0.91||||0.5876|TWO_SIDED|95.0|0.65|1.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.27|0.65|0.5876
73974752|NCT01074294|147494967|SUPERIORITY||Risk Ratio (RR)|0.87||||0.3727|TWO_SIDED|95.0|0.64|1.18||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.18|0.64|0.3727
73974753|NCT01074294|147494967|SUPERIORITY||Risk Ratio (RR)|0.93||||0.6265|TWO_SIDED|95.0|0.71|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.23|0.71|0.6265
73974754|NCT01074294|147494968|SUPERIORITY||Risk Ratio (RR)|1.1||||0.8586|TWO_SIDED|95.0|0.4|3.03||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||3.03|0.40|0.8586
73974755|NCT01074294|147494968|SUPERIORITY||Risk Ratio (RR)|0.95||||0.8984|TWO_SIDED|95.0|0.46|1.99||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||1.99|0.46|0.8984
73974756|NCT01074294|147494968|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9778|TWO_SIDED|95.0|0.57|1.74||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.74|0.57|0.9778
73974757|NCT01074294|147494968|SUPERIORITY||Risk Ratio (RR)|0.92||||0.7315|TWO_SIDED|95.0|0.56|1.5||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.50|0.56|0.7315
73974758|NCT01074294|147494968|SUPERIORITY||Risk Ratio (RR)|0.9||||0.6518|TWO_SIDED|95.0|0.57|1.42||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.42|0.57|0.6518
73974759|NCT01074294|147494968|SUPERIORITY||Risk Ratio (RR)|0.82||||0.3472|TWO_SIDED|95.0|0.55|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.23|0.55|0.3472
73974760|NCT01074294|147494969|SUPERIORITY||Risk Ratio (RR)|0.98||||0.9577|TWO_SIDED|95.0|0.44|2.16||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.16|0.44|0.9577
73974761|NCT01074294|147494969|SUPERIORITY||Risk Ratio (RR)|1.19||||0.5864|TWO_SIDED|95.0|0.63|2.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.27|0.63|0.5864
74031248|NCT02436577|147615974|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.47|||||TWO_SIDED|90.0|91.99|99.08|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||99.08|91.99|
73941707|NCT00781391|147415281|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|97.5|0.632|0.985||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.||.985|.632|<.0001
73941708|NCT00781391|147415281|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|1.07||||0.0055|TWO_SIDED|97.5|0.874|1.314||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.||1.314|.874|.0055
73941709|NCT00781391|147415282|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|97.5|0.719|1.029|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.029|.719|<.0001
73941710|NCT00781391|147415282|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|1.13||||0.0074|TWO_SIDED|97.5|0.955|1.336|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.336|.955|.0074
73941711|NCT00781391|147415283|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|97.5|0.634|0.989|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||.989|.634|<.0001
73974762|NCT01074294|147494969|SUPERIORITY||Risk Ratio (RR)|0.96||||0.8723|TWO_SIDED|95.0|0.57|1.6||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.60|0.57|0.8723
73974763|NCT01074294|147494969|SUPERIORITY||Risk Ratio (RR)|1.0||||0.9872|TWO_SIDED|95.0|0.65|1.52||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.52|0.65|0.9872
73868262|NCT02161757|147281696|SUPERIORITY||LS Mean difference|1.77|||||TWO_SIDED|95.0|-7.99|11.53|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||11.53|-7.99|
73941712|NCT00781391|147415283|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.|Hazard Ratio (HR)|1.08||||0.0064|TWO_SIDED|97.5|0.878|1.32|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.32|.878|.0064
73974764|NCT01074294|147494969|SUPERIORITY||Risk Ratio (RR)|0.8||||0.3171|TWO_SIDED|95.0|0.52|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.23|0.52|0.3171
73974765|NCT01074294|147494969|SUPERIORITY||Risk Ratio (RR)|0.87||||0.4782|TWO_SIDED|95.0|0.6|1.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.27|0.60|0.4782
73974766|NCT01074294|147494970|SUPERIORITY||Risk Ratio (RR)|1.19||||0.7232|TWO_SIDED|95.0|0.45|3.19||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||3.19|0.45|0.7232
73974767|NCT01074294|147494970|SUPERIORITY||Risk Ratio (RR)|0.99||||0.986|TWO_SIDED|95.0|0.46|2.13||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.13|0.46|0.9860
73868263|NCT02161757|147281696|SUPERIORITY||LS Mean difference|7.14|||||TWO_SIDED|95.0|-2.6|16.87|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||16.87|-2.60|
73868264|NCT02161757|147281696|SUPERIORITY||LS Mean difference|0.61|||||TWO_SIDED|95.0|-9.13|10.35|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||10.35|-9.13|
73868265|NCT02161757|147281697|SUPERIORITY||LS Mean difference|-1.8|||||TWO_SIDED|95.0|-5.29|1.69|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||1.69|-5.29|
73941713|NCT00781391|147415284|NON_INFERIORITY_OR_EQUIVALENCE|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|97.5|0.72|1.032|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.||1.032|.720|<.0001
73941714|NCT00781391|147415284|NON_INFERIORITY_OR_EQUIVALENCE|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|1.13||||0.0084|TWO_SIDED|97.5|0.958|1.34|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.||1.34|.958|.0084
74031249|NCT03703375|147615989|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0541|TWO_SIDED|95.0|0.41|1.09|||Stratified Cox|Stratified Cox proportional hazards model||||1.09|0.41|0.0541
74031250|NCT03703375|147615990|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0166|TWO_SIDED|95.0|0.32|0.96|||Efron|Stratified Cox proportional hazards model||||0.96|0.32|0.0166
74031251|NCT03703375|147615991|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2139|TWO_SIDED|95.0|0.51|1.33|||Stratified Cox|Stratified Cox proportional hazards model||||1.33|0.51|0.2139
74031252|NCT00903032|147616022|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.003|TWO_SIDED||||||Chi-squared|||Unpaired t tests were used to compare continuous variables, and χ2 testswere used to compare categorical variables across the intervention and usual care. We used a log-rank test to compare the hazardof first hospitalization for MI, revascularization, or death.We used a Wilcoxon rank sum test to compare PDCs between study arms. For all other outcomes, χ2 tests and t testswere used for comparisons, as appropriate.||||0.003
74031253|NCT00931892|147616023|OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.670
73941715|NCT00781391|147415285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.081|TWO_SIDED|99.0|0.709|1.068|||Log Rank|||The superiority analysis included the ITT analysis set||1.068|.709|.081
74031254|NCT00931892|147616024|OTHER|||||||0.409|||||||t-test, 2 sided|||||||0.409
74031255|NCT00931892|147616025|OTHER|||||||0.387|||||||t-test, 2 sided|||||||0.387
74031256|NCT00931892|147616025|OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
74031257|NCT00931892|147616026|SUPERIORITY|||||||0.01|||||||ANOVA|||P Value for IgA anti-tTG||||0.010
74031258|NCT00931892|147616026|SUPERIORITY|||||||0.036|||||||ANOVA|||P Value for IgA/IgG anti-DGP||||0.036
74031259|NCT00931892|147616026|SUPERIORITY|||||||0.013|||||||ANOVA|||P Value for IgA anti-tTG||||0.013
74031260|NCT00931892|147616026|SUPERIORITY|||||||0.006|||||||ANOVA|||P Value for IgA/IgG anti-DGP||||0.006
74031261|NCT00931892|147616028|OTHER|||||||0.05|||||||t-test, 2 sided|||P Value for Celiac Symptom Index (CSI) score for Day 3 of Gluten Challenge||||0.05
73868266|NCT02161757|147281697|SUPERIORITY||LS Mean difference|-2.36|||||TWO_SIDED|95.0|-5.84|1.12|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||1.12|-5.84|
73868267|NCT02161757|147281698|SUPERIORITY||Odds Ratio (OR)|0.95||||0.732|TWO_SIDED|95.0|0.71|1.28|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q2W vs placebo.||1.28|0.71|0.732
74031262|NCT00931892|147616028|OTHER|||||||0.02|||||||t-test, 2 sided|||P Value for Celiac Symptom Index (CSI) Score from baseline to Day 14||||0.020
74031263|NCT00931892|147616028|SUPERIORITY|||||||0.06|||||||ANOVA|||P Value for Celiac Symptom Index (CSI)score between high gluten group and low gluten group across study||||0.060
74031264|NCT00931892|147616030|OTHER|||||||0.01|||||||t-test, 2 sided|||P Value for the Gastrointestinal Symptom Rating Scale (GSRS) on Day 3 of the Gluten Challenge||||0.01
74031265|NCT00931892|147616030|OTHER|||||||0.012|||||||t-test, 2 sided|||P Value for Gastrointestinal Symptom Rating Scale (GSRS) from baseline to Day 14 of Gluten Challenge||||0.012
74031266|NCT00931892|147616030|SUPERIORITY|||||||0.09|||||||ANOVA|||P Value for Gastrointestinal Symptom Rating Scale (GSRS) between high gluten group and low gluten group across study||||0.090
74031267|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.047||||||"P- value for social function"|Wilcoxon signed-rank test|||||||0.047
74031268|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.688||||||"P- value of  symptom/problem list "|Wilcoxon signed-rank test|||||||0.688
74031269|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.772||||||"P- value of  effects of kidney disease "|Wilcoxon signed-rank test|||||||0.772
73868268|NCT02161757|147281698|SUPERIORITY||Odds Ratio (OR)|0.88||||0.421|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q4W vs placebo.||1.19|0.65|0.421
73868269|NCT03368235|147281734|OTHER||LS mean difference|0.472|STANDARD_ERROR_OF_MEAN|0.4569||0.315|TWO_SIDED|95.0|-0.487|1.431||Based on MMRM model with the baseline DAS28-CRP score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||MMRM = mixed model repeated measures.||1.431|-0.487|0.315
73868270|NCT03368235|147281735|OTHER||Odds Ratio (OR)|0.807||||0.807|TWO_SIDED|95.0|0.12|5.34||Logistic regression model with the treatment group, country and baseline DAS28-CRP as covariate.|Regression, Logistic|||Treatment comparison ACR20: AZD9567 Vs prednisolone||5.34|0.12|0.807
73868271|NCT03368235|147281735|OTHER|||||||0.198|||||||Fisher Exact|||Treatment comparison ACR50: AZD9567 Vs prednisolone||||0.198
73868272|NCT03368235|147281735|OTHER|||||||0.183|||||||Fisher Exact|||Treatment comparison ACR70: AZD9567 Vs prednisolone||||0.183
73868273|NCT03368235|147281736|OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.136||0.717|TWO_SIDED|95.0|-1.98|2.81||The MMRM with the baseline SJC66 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||2.81|-1.98|0.717
73868274|NCT03368235|147281737|OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|3.115||0.724|TWO_SIDED|95.0|-7.69|5.46||The MMRM with the baseline TJC68 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||5.46|-7.69|0.724
73868275|NCT03368235|147281738|OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|1.6||0.973|TWO_SIDED|95.0|-3.43|3.32||The MMRM with the baseline TJC28 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||3.32|-3.43|0.973
74031270|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.301||||||"P-value of  burden of kidney disease "|Wilcoxon signed-rank test|||||||0.301
73868276|NCT03368235|147281739|OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.837||0.757|TWO_SIDED|95.0|-1.5|2.03||The MMRM with the baseline SJC28 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||2.03|-1.50|0.757
73868277|NCT03368235|147281740|OTHER||LS mean difference|9.8|STANDARD_ERROR_OF_MEAN|9.67||0.325|TWO_SIDED|95.0|-10.5|30.1||The MMRM with the baseline GH score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||30.1|-10.5|0.325
73868278|NCT03368235|147281741|OTHER||LS mean difference|4.756|STANDARD_ERROR_OF_MEAN|3.4725||0.187|TWO_SIDED|95.0|-2.514|12.025||The MMRM with the baseline CRP score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||12.025|-2.514|0.187
73868279|NCT03368235|147281742|OTHER||LS mean difference|16.0|STANDARD_ERROR_OF_MEAN|10.49||0.144|TWO_SIDED|95.0|-6.0|38.1||The MMRM with the baseline participant's assessment of pain score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||38.1|-6.0|0.144
73868280|NCT03368235|147281743|OTHER||LS mean difference|3.8|STANDARD_ERROR_OF_MEAN|5.73||0.512|TWO_SIDED|95.0|-8.3|16.0||The MMRM with the baseline disease activity score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||16.0|-8.3|0.512
73868281|NCT03368235|147281744|OTHER||LS mean difference|0.131|STANDARD_ERROR_OF_MEAN|0.2381||0.589|TWO_SIDED|95.0|-0.37|0.631||The MMRM with the baseline physical function score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||0.631|-0.370|0.589
73868282|NCT02828020|147281750|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0023|TWO_SIDED|95.0|1.25|2.66||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.66|1.25|0.0023
73868283|NCT02828020|147281750|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0003|TWO_SIDED|95.0|1.41|2.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.95|1.41|0.0003
73868284|NCT02828020|147281751|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0023|TWO_SIDED|95.0|1.27|2.28||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.28|1.27|0.0023
73868285|NCT02828020|147281751|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0023|TWO_SIDED|95.0|1.22|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.17|1.22|0.0023
73868286|NCT02828020|147281752|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0023|TWO_SIDED|95.0|1.28|2.23||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.23|1.28|0.0023
74031271|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.25||||||"P-value of  work status "|Wilcoxon signed-rank test|||||||0.250
74031272|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.895||||||"P-value of  cognitive function "|Wilcoxon signed-rank test|||||||0.895
74031273|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.281||||||"P-value of  quality of social interaction "|Wilcoxon signed-rank test|||||||0.281
73941716|NCT00781391|147415286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0053|TWO_SIDED|95.0|0.786|0.959|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.959|.786|.0053
73941717|NCT00781391|147415287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0109|TWO_SIDED|95.0|0.806|0.972|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.972|.806|.0109
73941718|NCT00781391|147415288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0168|TWO_SIDED|95.0|0.823|0.981|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.981|.823|.0168
73941719|NCT00781391|147415289|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.0009|TWO_SIDED|95.0|0.707|0.914|||Regression, Cox|||All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period||.914|.707|.0009
73941720|NCT00781391|147415289|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.47|||<|0.0001|TWO_SIDED|95.0|0.406|0.548|||Regression, Cox|||"All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period.~The HR, two-sided CI, and p-value for pairwise comparisons versus Warfarin are based on the Cox regression model with counting process approach for on-treatment including treatment and the two stratification factors as covariates: the dichotomized CHADS2 score and the dichotomized dose-adjustment factor"||.548|.406|<.0001
73941721|NCT00781391|147415289|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||<|0.0001|TWO_SIDED|95.0|0.8|0.918|||Regression, Cox|||Major or Clinically Relevant Non-Major, high dose vs. warfarin||.918|.800|<.0001
73941722|NCT00781391|147415289|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.575|0.666|||Regression, Cox|||Major or Clinically Relevant Non-Major, low dose vs. warfarin||.666|.575|<.0001
73941723|NCT04322604|147415298|SUPERIORITY||Percent Difference from Placebo|80.1|||<|0.0001|TWO_SIDED|95.0|70.1|87.9|||Fisher Exact|||||87.9|70.1|<0.0001
73941724|NCT04322604|147415299|SUPERIORITY||LSM Difference from Placebo|1.5||||0.3427|TWO_SIDED|95.0|-1.6|4.7|||ANCOVA|||||4.7|-1.6|0.3427
73941725|NCT04322604|147415300|SUPERIORITY||LSM Difference from Placebo|-41.2|||<|0.0001|TWO_SIDED|95.0|-48.1|-34.2|||ANCOVA|||||-34.2|-48.1|<0.0001
73941726|NCT04322604|147415301|SUPERIORITY||Percent Difference from Placebo|81.3|||<|0.0001|TWO_SIDED|95.0|71.7|88.8|||Fisher Exact|||||88.8|71.7|<0.0001
73941727|NCT04322604|147415302|SUPERIORITY||Percent Difference from Placebo|39.5|||<|0.0001|TWO_SIDED|95.0|25.4|52.2|||Fisher Exact|||||52.2|25.4|<0.0001
73941728|NCT04322604|147415303|SUPERIORITY||Percent Difference from Placebo|7.0||||0.3549|TWO_SIDED|95.0|-7.4|21.6|||Fisher Exact|||||21.6|-7.4|0.3549
73941729|NCT04322604|147415304|SUPERIORITY||Percent Difference from Placebo|8.3||||0.2262|TWO_SIDED|95.0|-6.3|22.7|||Fisher Exact|||||22.7|-6.3|0.2262
73941730|NCT04322604|147415305|SUPERIORITY||LSM Difference from Placebo|5.0||||0.3812|TWO_SIDED|95.0|-6.1|16.0|||Mixed Models Analysis|||Week 24 Percent Change from Baseline||16.0|-6.1|0.3812
73941731|NCT02413580|147415333|OTHER|The hypothesis test is to test the null hypothesis: H0: μd = 0 versus alternative hypothesis Ha: μd ≠ 0 where μd is the mean change from Baseline to Day 14. The Shapiro-Wilk test is used to test the normality. If the assumptions for parametric test are met, a paired t-test (comparison between the pre- and post-treatment) is used to test for the treatment effect. Otherwise, a non-parametric test (Wilcoxon signed rank test) is used.|Mean Difference (Final Values)|-6.4|||<|0.001|TWO_SIDED|95.0|-7.957|-4.787|||Paired t-test|||||-4.787|-7.957|<0.001
74031274|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  sleep "|Wilcoxon signed-rank test|||||||1.00
73941732|NCT00689221|147415345|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.021||||0.8623|TWO_SIDED|95.0|0.808|1.291||P-value is not adjusted for multiple testing.|Log Rank|||||1.291|0.808|0.8623
73941733|NCT01812655|147415357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.7||||0.029|TWO_SIDED|95.0|2.4|45.0|||Regression, Linear||Mean difference = PD group - VR group|||45.0|2.4|0.029
73941734|NCT01812655|147415357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.32|TWO_SIDED|95.0|-9.5|28.9|||Regression, Linear||Mean difference = VR group - SC group|||28.9|-9.5|0.32
73941735|NCT01812655|147415358|SUPERIORITY_OR_OTHER||Semipartial correlation|0.223||||0.26||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC State Anxiety measured at Baseline for all participants|||||.26
73941736|NCT01812655|147415358|SUPERIORITY_OR_OTHER||Semipartial correlation|0.119||||0.59||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC Trait Anxiety measured at Baseline for all participants|||||.59
73941737|NCT01812655|147415358|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.059||||0.6||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and Procedural Pain (Outcome Measure #1) for all participants|||||.60
73941738|NCT01812655|147415359|SUPERIORITY_OR_OTHER||semipartial correlation|-0.276||||0.15||95.0|||||Semipartial Correlation||Semipartial correlation between Engagement with Distraction and STAIC State Anxiety measured at Baseline for all participants|||||0.15
73941739|NCT01812655|147415359|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.347||||0.18||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and STAIC Trait Anxiety measured at Baseline for all participants|||||0.18
73941740|NCT01812655|147415359|SUPERIORITY_OR_OTHER||Semipartial correlation|0.21||||0.054||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and Procedural Pain (Outcome Measure #1) for all participants|||||0.054
73941741|NCT01812655|147415359|SUPERIORITY_OR_OTHER||Semipartial Correlation|-0.102||||0.61||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC State Anxiety measured at Baseline for all participants|||||0.61
73941742|NCT01812655|147415359|SUPERIORITY_OR_OTHER||Semipartial Correlation|-0.622||||0.007||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC Trait Anxiety measured at Baseline for all participants|||||0.007
74031275|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  social support "|Wilcoxon signed-rank test|||||||1.00
73941743|NCT01812655|147415359|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.217||||0.045||95.0|||||Semipartial correlation||Semipartial correlation between Belief in Distraction's Efficacy and Procedural Pain (Outcome Measure #1) for all participants|||||0.045
73941744|NCT04672941|147415372|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was the CAT score at each visit. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|-5.28|||||TWO_SIDED|95.0|-5.67|-4.89|||||Least Square Mean for Visit, change from baseline (3 months - baseline) total CAT Score estimates.|||-4.89|-5.67|
73941745|NCT04672941|147415373|OTHER|The logistic generalized estimating equations (GEE) model with CAT response \>= 10 as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|7.186|||<|0.001|TWO_SIDED|95.0|5.745|8.987|||Regression, Logistic||Odds ratio for Visit.|||8.987|5.745|< 0.001
73974768|NCT01074294|147494970|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9858|TWO_SIDED|95.0|0.52|1.95||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.95|0.52|0.9858
73974769|NCT01074294|147494970|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9466|TWO_SIDED|95.0|0.58|1.78||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.78|0.58|0.9466
74031276|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.943||||||"P-value of  dialysis staff encouragement "|Wilcoxon signed-rank test|||||||0.943
73868287|NCT02828020|147281752|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0023|TWO_SIDED|95.0|1.28|2.21||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.21|1.28|0.0023
74089169|NCT03575871|147731441|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.0|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.0|-2.5|<0.0001
73868288|NCT02828020|147281753|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0023|TWO_SIDED|95.0|1.65|3.07||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||3.07|1.65|0.0023
73941746|NCT04672941|147415374|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was EQ-VAS score. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|11.8|||||TWO_SIDED|95.0|11.0|12.6|||||Least Square Mean for Visit, mean change from Baseline (3 months - baseline) of EQ-VAS based on non-responder imputation.|||12.60|11.00|
73974770|NCT01074294|147494970|SUPERIORITY||Risk Ratio (RR)|1.12||||0.6962|TWO_SIDED|95.0|0.63|2.0||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||2.00|0.63|0.6962
73974771|NCT01074294|147494970|SUPERIORITY||Risk Ratio (RR)|0.93||||0.7637|TWO_SIDED|95.0|0.57|1.51||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.51|0.57|0.7637
73974772|NCT01074294|147494971|SUPERIORITY||Risk Ratio (RR)|1.3||||0.3631|TWO_SIDED|95.0|0.73|2.33||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.33|0.73|0.3631
73974773|NCT01074294|147494971|SUPERIORITY||Risk Ratio (RR)|1.35||||0.2786|TWO_SIDED|95.0|0.78|2.35||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.35|0.78|0.2786
74031277|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  overall health "|Wilcoxon signed-rank test|||||||1.00
74031278|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.09||||||"P-value of  patient satisfaction "|Wilcoxon signed-rank test|||||||0.090
74031279|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.391||||||"P-value of  physical functioning "|Wilcoxon signed-rank test|||||||0.391
74031280|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.438||||||"P-value of  role-physical "|Wilcoxon signed-rank test|||||||0.438
74031281|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.424||||||"P-value of  pain "|Wilcoxon signed-rank test|||||||0.424
74031282|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.169||||||"P-value of  general health "|Wilcoxon signed-rank test|||||||0.169
73868289|NCT02828020|147281753|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0023|TWO_SIDED|95.0|1.77|3.24||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||3.24|1.77|0.0023
73868290|NCT02828020|147281754|SUPERIORITY||Odds Ratio (OR)|1.57||||0.0577|TWO_SIDED|95.0|1.01|2.44||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.44|1.01|0.0577
73941747|NCT04672941|147415375|OTHER|The logistic generalized estimating equations (GEE) model with mobility as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|4.48|||<|0.001|TWO_SIDED|95.0|3.9|5.14|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||5.14|3.90|< 0.001
73941748|NCT04672941|147415376|OTHER|The logistic generalized estimating equations (GEE) model with self-care as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|2.64|||<|0.001|TWO_SIDED|95.0|2.35|2.96|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||2.96|2.35|< 0.001
73941749|NCT04672941|147415377|OTHER|The logistic generalized estimating equations (GEE) model with usual activities as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|4.46|||<|0.001|TWO_SIDED|95.0|3.89|5.12|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||5.12|3.89|< 0.001
73941750|NCT04672941|147415378|OTHER|The logistic generalized estimating equations (GEE) model with pain/discomfort as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|3.0|3.85|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||3.85|3.00|< 0.001
73941751|NCT04672941|147415379|OTHER|The logistic generalized estimating equations (GEE) model with anxiety/depression as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|3.32|||<|0.001|TWO_SIDED|95.0|2.95|3.73|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||3.73|2.95|< 0.001
73941752|NCT04672941|147415385|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was the mMRC score. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|-0.55|||||TWO_SIDED|95.0|-0.6|-0.51|||||Least Square Mean for Visit, change from baseline (3 months - baseline) of mMRC based on non-responder imputation.|||-0.51|-0.60|
73941753|NCT00765388|147415390|SUPERIORITY_OR_OTHER|||||||0.96|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products||||||0.96
73974774|NCT01074294|147494971|SUPERIORITY||Risk Ratio (RR)|1.08||||0.7062|TWO_SIDED|95.0|0.72|1.62||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.62|0.72|0.7062
73974775|NCT01074294|147494971|SUPERIORITY||Risk Ratio (RR)|0.95||||0.7844|TWO_SIDED|95.0|0.67|1.35||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.35|0.67|0.7844
73941754|NCT00765388|147415392|SUPERIORITY_OR_OTHER|||||||0.92|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products||||||0.92
73941755|NCT00765388|147415394|SUPERIORITY_OR_OTHER|||||||0.4||0.0|||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.40
73941756|NCT00765388|147415395|SUPERIORITY_OR_OTHER|||||||0.64|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.64
73941757|NCT00765388|147415396|SUPERIORITY_OR_OTHER|||||||0.55|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.55
73941758|NCT00765388|147415397|SUPERIORITY_OR_OTHER|||||||0.48|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.48
73941759|NCT01786967|147415405|SUPERIORITY|This was a pilot study to provide preliminary data to inform future sample size estimates for a larger more definitive trial|Risk Ratio (RR)|0.96||||1|TWO_SIDED|95.0|0.53|1.71|||Fisher Exact|||Null hypothesis was that there will be no difference in treatment benefit scale between the two groups||1.71|0.53|1.0
73974776|NCT01074294|147494971|SUPERIORITY||Risk Ratio (RR)|1.07||||0.694|TWO_SIDED|95.0|0.77|1.48||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.48|0.77|0.6940
73974777|NCT01074294|147494971|SUPERIORITY||Risk Ratio (RR)|1.03||||0.8697|TWO_SIDED|95.0|0.76|1.39||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.39|0.76|0.8697
74031283|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.858||||||"P-value of  emotional well-being "|Wilcoxon signed-rank test|||||||0.858
73941760|NCT01786967|147415406|SUPERIORITY||Risk Ratio (RR)|0.85||||1|TWO_SIDED|95.0|0.76|0.95|||Fisher Exact|||Null hypothesis was that there was no difference in the rate of moderate to severe adverse events.||.95|.76|1.0
73941761|NCT01563536|147415424|SUPERIORITY_OR_OTHER||Mean Difference (Maximal Decrease)|-1.5||||0.035|TWO_SIDED|95.0|-2.81|-0.13||Pre-specified 2-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with the baseline log10 HCV RNA values as a covariate and with an effect for treatment arm.||||-0.13|-2.81|0.035
74031284|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.156||||||"P-value of  role-emotional "|Wilcoxon signed-rank test|||||||0.156
74031285|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.084||||||"P-value of  energy/fatigue "|Wilcoxon signed-rank test|||||||0.084
74031286|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.583||||||"P-value of  SF-12 physical composite "|Wilcoxon signed-rank test|||||||0.583
74031287|NCT01876732|147616032|SUPERIORITY_OR_OTHER|||||||0.358||||||"p-value of  SF-12 mental composite "|Wilcoxon signed-rank test|||||||0.358
73941762|NCT00538590|147415428|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.95
73941763|NCT00538590|147415430|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||1.00
73941764|NCT00538590|147415431|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.40
73941765|NCT00538590|147415432|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.91
73941766|NCT00567190|147415448|SUPERIORITY||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75||Tested at two-sided 5% significance level|Log Rank (stratified)|Stratified by prior treatment status and region|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.||0.75|0.51|<0.0001
73941767|NCT00567190|147415448|SUPERIORITY||Cox Proportional Hazard|0.63|||<|0.0001|TWO_SIDED|95.0|0.52|0.76||Tested at two-sided 5% significance level|Log Rank (unstratified)|Unstratified|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.||0.76|0.52|<0.0001
73941768|NCT00567190|147415449|SUPERIORITY|Exploratory|Cox Proportional Hazard|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|End-of-Study OS Analysis: This end-of-study OS analysis is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.||0.82|0.58|<0.0001
73941769|NCT00567190|147415449|SUPERIORITY|Exploratory|Cox Proportional Hazard|0.68||||0.0002|TWO_SIDED|95.0|0.56|0.84||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|Event-Driven Final OS Analysis: This final OS analysis was event-driven and planned to take place after a total of 385 deaths had occurred. It is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.||0.84|0.56|0.0002
73941770|NCT00567190|147415449|SUPERIORITY||Cox Proportional Hazard|0.66||||0.0008|TWO_SIDED|95.0|0.52|0.84||The threshold for statistical significance was HR≤0.739, p≤0.0138.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing Pertuzumab arm with Placebo arm.|Second Interim OS Analysis: For this second interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.739, p≤0.0138.||0.84|0.52|0.0008
73941771|NCT00567190|147415449|SUPERIORITY||Cox Proportional Hazard|0.64||||0.005|TWO_SIDED|95.0|0.47|0.88||The threshold for statistical significance was HR≤0.603, p≤0.0012.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing pertuzumab with placebo arms.|First Interim OS Analysis: For this first interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.603, p≤0.0012.||0.88|0.47|0.0050
73941772|NCT00567190|147415450|SUPERIORITY||Cox Proportional Hazard|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.81|||Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|PFS by Investigator - Stratified||0.81|0.59|<0.0001
73941773|NCT00567190|147415451|SUPERIORITY||Difference in Objective Response Rates|10.83||||0.0011|TWO_SIDED|95.0|4.2|17.5|||Mantel Haenszel|Stratified by prior treatment status and region.|Difference in the objective response rates between arms is calculated as Pertuzumab arm minus Placebo arm. The 95% CI was calculated using the Hauck-Anderson method.|Difference in Objective Response (CR + PR) Between Arms||17.5|4.2|0.0011
73941774|NCT00567190|147415451|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED|95.0|1.26|2.54||||||Odds Ratio for Objective Response (CR + PR)||2.54|1.26|
73941775|NCT00567190|147415452|SUPERIORITY||Cox Proportional Hazard|0.66|||||TWO_SIDED|95.0|0.51|0.85||||||||0.85|0.51|
73941776|NCT00567190|147415453|SUPERIORITY||Cox Proportional Hazard|0.97||||0.7161|TWO_SIDED|95.0|0.81|1.16||Stratified by prior treatment status and region.|Log Rank (stratified)||Hazard ratio is comparing Pertuzumab arm with Placebo arm.|||1.16|0.81|0.7161
73974778|NCT00112359|147494972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.98||||0.0006|TWO_SIDED|95.0|3.5|12.47||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 14.||12.47|3.50|0.0006
73974779|NCT00112359|147494973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33||||0.0154|TWO_SIDED|95.0|1.22|11.43||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 42.||11.43|1.22|0.0154
73974780|NCT00112359|147494976|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.294|||<|0.0001|TWO_SIDED|95.0|6.288|14.299||Analysis based on two-sided test with an 0.025 a priori threshold for statistical significance as part of the methods used to control the family-wise type 1 error.|ANCOVA|ANCOVA model included treatment, disease severity (FEV1 \>50% or \<=50% pred.), and Day 0 FEV1. Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in percent change in FEV1 at Day 28.||14.299|6.288|<0.0001
73974781|NCT00112359|147494977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.453|||<|0.0001|TWO_SIDED|95.0|-2.115|-0.791||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|ANCOVA|ANCOVA model included terms for treatment and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change in log10 PA CFUs in sputum at Day 28.||-0.791|-2.115|< 0.0001
74031288|NCT00321984|147616044|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
73868291|NCT02828020|147281754|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0037|TWO_SIDED|95.0|1.28|2.97||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.97|1.28|0.0037
73868292|NCT02828020|147281755|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0577|TWO_SIDED|95.0|1.22|2.19||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.19|1.22|0.0577
73868293|NCT02828020|147281755|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0037|TWO_SIDED|95.0|1.36|2.42||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.42|1.36|0.0037
73868294|NCT02828020|147281756|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0577|TWO_SIDED|95.0|1.16|2.09||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||2.09|1.16|0.0577
73868295|NCT02828020|147281756|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0577|TWO_SIDED|95.0|1.1|1.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.95|1.10|0.0577
73868296|NCT02828020|147281757|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0962|TWO_SIDED|95.0|0.96|1.79||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.79|0.96|0.0962
73868297|NCT02828020|147281757|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0962|TWO_SIDED|95.0|1.0|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.83|1.00|0.0962
73941777|NCT00567190|147415462|OTHER|||||||0.7174|||||||Wilcoxon Rank Sum Test|||Wilcoxon Test of Maximum Decrease in LVEF From BL||||0.7174
74031289|NCT00321984|147616044|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
73868298|NCT00847197|147281777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.1||0.926|TWO_SIDED|95.0|-3.9|4.3||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.||4.3|-3.9|0.926
73868299|NCT00847197|147281778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|1.8||0.013|TWO_SIDED|95.0|1.0|8.1||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.||8.1|1.0|0.013
73868300|NCT00847197|147281779|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|8.6||0.02|TWO_SIDED|95.0|-18.9|-1.9|||Wilcoxon's Rank Sum Test|The significance test was 2-tailed with α=0.05.||Triglycerides was analyzed by non-parametric methods with terms for treatment, gender and region. Specifically, the analysis of variance (ANOVA) model was applied to the Tukey's normal scores of the percent change from baseline. The estimate of the difference in medians between MK1903 and the placebo groups utilizing the Hodges-Lehmann estimate and a distribution-free 95% CI for the difference based on Wilcoxon's rank sum test was provided.||-1.9|-18.9|0.02
73941778|NCT02048072|147415528|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
73941779|NCT02276222|147415551|SUPERIORITY||Least Squares Mean (SE)|0.0084|STANDARD_ERROR_OF_MEAN|0.01012||0.4041|TWO_SIDED|95.0|-0.0114|0.0283|||ANCOVA|||||0.0283|-0.0114|0.4041
73941780|NCT01971723|147415552|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||ANOVA|Groups were compared against each other at the two different time points and against themselves at the same time points.||This statistical analysis is for the squat one repetition maximum outcomes, only.||||.38
73941781|NCT01971723|147415552|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||This statistical analysis is for the bench press one repetition maximum outcomes, only.||||0.0001
74031290|NCT00321984|147616044|SUPERIORITY_OR_OTHER|||||||0.72941||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.72941
74031291|NCT00321984|147616046|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
73868301|NCT01743040|147281780|NON_INFERIORITY|15% equivalency margin against performance of SPECT nuclear stress test OPC. Both sensitivity and specificity were measured and the equivalency margin was set the same for both parameters.The goal was to test the Sensitivity and specificity of CADence as compared to SPECT nuclear stress test OPC. Both were measured and reported in this study. The Sensitivity of CADence was 78% (95% CI 76.1-90.8%) while the specificity was 36% (95% CI 32-39%).||||||0.012|||||||Exact binomial test|||The goal was to test the Sensitivity and specificity of CADence as compared to SPECT nuclear stress test OPC. Both were measured and reported in this study. The Sensitivity of CADence was 78% (95% CI 76.1-90.8%) while the specificity was 36% (95% CI 32-39%).||||0.012
73868302|NCT00223704|147281792|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||This P-value is for the main comparison of receiving any transfusion.|Chi-squared|||||||0.72
73868303|NCT00223704|147281793|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.88
73868304|NCT00223704|147281794|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.43
73868305|NCT00223704|147281795|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||The P-value reflects the difference in Interleukin-6 concentrations among the 3 treatment groups over the course of the study (baseline, post-bypass, postoperative day 1 and 2)|Mixed Models Analysis|||The time course for Interleukin-6 concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model||||0.92
73868306|NCT00223704|147281796|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value reflects the difference in D-dimer concentrations among the 3 treatment groups over the course of the study (baseline, 30min, 60min, post-bypass, and postoperative day 1)|Mixed Models Analysis|||The time course for D-dimer concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model||||<0.001
73868307|NCT01990612|147281815|SUPERIORITY||Risk Ratio (RR)|0.8||||0.049|TWO_SIDED|95.0|0.64|1.0|||Chi-squared|Group sequential method to control type I error w/ Lan-DeMets characterization of O'Brien-Fleming boundary. 2-tailed p-value \<0.46 considered stat sig|One interim analysis was performed; in final analysis of the primary outcome, a two-tailed P value of less than 0.046 considered to indicate statistical significance. Since adjustment is minimal, we report 95% confidence interval for relative risk.|||1.00|0.64|0.049
73868308|NCT01990612|147281816|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.12|3.33|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||3.33|0.12|
73868309|NCT01990612|147281817|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.55|0.93||||||||0.93|0.55|
74031292|NCT00321984|147616046|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
73868310|NCT01990612|147281818|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.32|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.37|0.32|
73868311|NCT01990612|147281819|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.35|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.37|0.35|
73868312|NCT01990612|147281820|SUPERIORITY||Risk Ratio (RR)|2.74|||||TWO_SIDED|95.0|0.91|8.12|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||8.12|0.91|
73868313|NCT01990612|147281821|SUPERIORITY||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.31|1.76|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.76|0.31|
73868314|NCT01990612|147281822|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.35|1.19|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.19|0.35|
73868315|NCT01990612|147281823|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.38|1.55|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.55|0.38|
73868316|NCT01990612|147281824|SUPERIORITY||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.48|3.42|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||3.42|0.48|
73868317|NCT01990612|147281825|SUPERIORITY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.06|1.79|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.79|0.06|
73868318|NCT01990612|147281826|SUPERIORITY||Risk Ratio (RR)|0.84|||<|0.001|TWO_SIDED|95.0|0.76|0.93||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.93|0.76|<0.001
74031293|NCT00321984|147616046|SUPERIORITY_OR_OTHER|||||||0.3146||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.31460
73941782|NCT01971723|147415552|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||This statistical analysis is for the deadlift one repetition maximum measures, only.||||.3
73941783|NCT01971723|147415552|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||This statistical analysis compares the outcomes of the total weight lifted.||||0.0001
73941784|NCT01971723|147415553|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
73941785|NCT01971723|147415554|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical measurement is for cholesterol measure outcomes, only.||||>.05
73941786|NCT01971723|147415554|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for glucose measure outcomes, only.||||>.05
73941787|NCT01971723|147415554|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for HDL measure outcomes, only.||||>.05
73941788|NCT01971723|147415554|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for LDL measure outcomes, only.||||>.05
73974782|NCT00112359|147494978|SUPERIORITY_OR_OTHER|||||||0.2364||95.0||||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|Fisher Exact|Comparison by treatment for proportion of subjects using additional (nonprotocol-specified) antipseudomonal antibiotics at least once during study.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.||||0.2364
73868319|NCT01990612|147281827|SUPERIORITY||Risk Ratio (RR)|0.58||||0.02|TWO_SIDED|95.0|0.36|0.92||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.92|0.36|0.02
73868320|NCT01990612|147281828|SUPERIORITY||Risk Ratio (RR)|0.85||||0.07|TWO_SIDED|95.0|0.72|1.01|||Chi-squared|||||1.01|0.72|0.07
73868321|NCT01990612|147281829|SUPERIORITY||Risk Ratio (RR)|0.94||||0.35|TWO_SIDED|95.0|0.83|1.07|||Chi-squared|||||1.07|0.83|0.35
73868322|NCT01990612|147281830|SUPERIORITY||Risk Ratio (RR)|1.15||||0.33|TWO_SIDED|95.0|0.87|1.52|||Chi-squared|||||1.52|0.87|0.33
73941789|NCT01971723|147415554|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis for the triglyceride measure outcomes, only.||||>.05
73941790|NCT01971723|147415555|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
73941791|NCT01971723|147415556|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
73941792|NCT01971723|147415557|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
73941793|NCT01971723|147415558|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
73941794|NCT01971723|147415559|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
73868323|NCT01990612|147281832|SUPERIORITY||Risk Ratio (RR)|0.5||||0.26|TWO_SIDED|95.0|0.13|1.55|||Chi-squared||Exact confidence intervals are provided for rare outcomes.|||1.55|0.13|0.26
73868324|NCT01990612|147281833|SUPERIORITY||Risk Ratio (RR)|0.64|||<|0.001|TWO_SIDED|95.0|0.56|0.74||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.74|0.56|<0.001
73941795|NCT01971723|147415560|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>.05
73941796|NCT01971723|147415561|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for deadlift volume measure outcomes, only.||||>.05
73941797|NCT01971723|147415561|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for auxiliary squat volume measure outcomes, only.||||>.05
73941798|NCT01971723|147415561|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for squat volume measure outcomes, only.||||>.05
73941799|NCT01971723|147415561|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for bench volume measure outcomes, only.||||>.05
73941800|NCT01971723|147415561|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for total squat volume measures, only.||||>.05
73941801|NCT01971723|147415561|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for total weight lifted volume measure outcomes, only.||||>.05
73941802|NCT01971723|147415562|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
73941803|NCT01971723|147415563|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
73941804|NCT01971723|147415564|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANOVA|||||||.05
73941805|NCT00902694|147415571|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.6|-0.4||||||6 month intervention versus control||-0.4|-2.6|
73941806|NCT00902694|147415571|SUPERIORITY||Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-5.1|-1.2||||||18 month intervention versus control||-1.2|-5.1|
73941807|NCT00902694|147415573|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-3.6|-0.4||||||6 month intervention versus control||-0.4|-3.6|
73941808|NCT00902694|147415573|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-4.1|0.3||||||18 month intervention versus control||0.3|-4.1|
73941809|NCT00902694|147415574|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-3.2|2.4||||||6 month systolic intervention versus control||2.4|-3.2|
73941810|NCT00902694|147415574|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.6|2.1||||||6 month diastolic intervention versus control||2.1|-1.6|
73941811|NCT00902694|147415574|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-1.6|4.8||||||18 month systolic intervention versus control||4.8|-1.6|
73941812|NCT00902694|147415574|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-0.9|3.4||||||18 month diastolic intervention versus control||3.4|-0.9|
73941813|NCT00902694|147415575|SUPERIORITY||Mean Difference (Net)|-2.9|||||TWO_SIDED|95.0|-9.9|4.1||||||6 month total chol intervention versus control||4.1|-9.9|
73941814|NCT00902694|147415575|SUPERIORITY||Mean Difference (Net)|-5.2|||||TWO_SIDED|95.0|-14.9|4.4||||||18 month total chol intervention versus control||4.4|-14.9|
73941815|NCT00902694|147415575|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-7.5|5.1||||||6 month LDL chol intervention versus control||5.1|-7.5|
73868325|NCT01990612|147281834|SUPERIORITY||Risk Ratio (RR)|1.03||||0.81|TWO_SIDED|95.0|0.82|1.29|||Chi-squared|||||1.29|0.82|0.81
73868326|NCT01990612|147281835|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 6-96 hours after delivery||||<0.001
73868327|NCT01990612|147281835|SUPERIORITY|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 4-8 weeks after delivery||||0.01
73868328|NCT01990612|147281836|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Worst labor pain score||||<0.001
73868329|NCT01990612|147281836|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Overall labor pain score||||<0.001
73868330|NCT01990612|147281837|SUPERIORITY||Risk Ratio (RR)|0.76||||0.15|TWO_SIDED|95.0|0.53|1.1|||Chi-squared|||||1.10|0.53|0.15
73868331|NCT01990612|147281838|SUPERIORITY||Risk Ratio (RR)|1.99||||1|TWO_SIDED|95.0|0.26|26.8|||Chi-squared|The P-values has not been adjusted for multiplicity of comparisons of secondary outcomes.|Exact confidence intervals are provided for rare outcomes.|||26.8|0.26|1.00
73868332|NCT01990612|147281840|SUPERIORITY|||||||0.01|||||||Cochran-Armitage trend test|||||||0.01
73868333|NCT01990612|147281841|SUPERIORITY||Risk Ratio (RR)|0.92||||0.56|TWO_SIDED|95.0|0.68|1.23|||Chi-squared|||||1.23|0.68|0.56
73868334|NCT01990612|147281842|SUPERIORITY||Risk Ratio (RR)|0.9||||0.56|TWO_SIDED|95.0|0.64|1.28|||Chi-squared|||||1.28|0.64|0.56
73868335|NCT01990612|147281843|SUPERIORITY||Risk Ratio (RR)|0.79||||0.75|TWO_SIDED|95.0|0.2|2.74|||Chi-squared||Exact confidence intervals are provided for rare outcomes.|||2.74|0.20|0.75
73868336|NCT01990612|147281844|SUPERIORITY||Risk Ratio (RR)|1.01||||0.91|TWO_SIDED|95.0|0.81|1.27|||Chi-squared|||||1.27|0.81|0.91
73868337|NCT01990612|147281845|SUPERIORITY||Risk Ratio (RR)|1.05||||0.84|TWO_SIDED|95.0|0.66|1.66|||Chi-squared|||||1.66|0.66|0.84
73868338|NCT01990612|147281846|SUPERIORITY||Risk Ratio (RR)|0.9||||0.13|TWO_SIDED|95.0|0.79|1.03|||Chi-squared|||||1.03|0.79|0.13
73868339|NCT01990612|147281847|SUPERIORITY||||||<|0.001|||||||Wilcoxon Rank-Sum|||||||<0.001
73868340|NCT01990612|147281848|SUPERIORITY|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test|||||||0.01
73868341|NCT01990612|147281849|SUPERIORITY|||||||0.002||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test|||||||0.002
73868342|NCT01990612|147281851|OTHER||Odds Ratio, log|1.01||||0.88|TWO_SIDED|95.0|0.89|1.15||Odds ratios from multinomial logistic regression.|Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are breastfeeding and formula feeding to participants who are only breastfeeding.||1.15|0.89|0.88
73868343|NCT01990612|147281851|OTHER||Odds Ratio, log|0.98||||0.78|TWO_SIDED|95.0|0.86|1.12|||Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are only formula feeding to participants who are only breastfeeding.||1.12|0.86|0.78
73868344|NCT00360724|147281855|SUPERIORITY_OR_OTHER||F statistics|9.43||||0.003|||||||Repeated Measures ANOVA|df 1,55|time X Drug group, f=9.43,df 1,55, p=.003|Repeated measures ANOVA was used to compare measures between baseline and week 10.||||.003
73868345|NCT00360724|147281857|SUPERIORITY_OR_OTHER||F statistics|8.72||||0.05|||||||Repeated Measures ANOVA|d.f. 1,55|Time x Treatment: F=8.72, d.f=1,55, p=0.05|Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.05
73868346|NCT00360724|147281858|SUPERIORITY_OR_OTHER||F statistics|5.33||||0.025|||||||Repeated measures ANOVA|d.f. 1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.025
73868347|NCT00360724|147281859|SUPERIORITY_OR_OTHER||F statistics|0.26||||0.6|||||||Repeated measures ANOVA|d.f.=1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.6
73868348|NCT00360724|147281864|OTHER||Mean Difference (Final Values)|4.0||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
73868349|NCT00360724|147281865|OTHER||Mean Difference (Final Values)|0.4||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
73868350|NCT02467582|147281870|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
73868351|NCT02467582|147281870|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|90.0|0.27|1.22|||||Unstratified|||1.22|0.27|
73868352|NCT02467582|147281870|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|90.0|0.22|1.46|||||Stratified|||1.46|0.22|
73868353|NCT02467582|147281871|SUPERIORITY|||||||0.089|||||||Log Rank|||||||0.089
73868354|NCT02467582|147281871|SUPERIORITY||Hazard Ratio (HR)|0.49|||||TWO_SIDED|90.0|0.21|1.19|||||Unstratified|||1.19|0.21|
73868355|NCT02467582|147281871|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|90.0|0.2|1.55|||||Stratified|||1.55|0.20|
73868356|NCT02467582|147281872|SUPERIORITY|||||||0.3|||||||Log Rank|||||||0.3
73868357|NCT02467582|147281872|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|90.0|0.23|2.13|||||Unstratified|||2.13|0.23|
73868358|NCT02467582|147281872|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|90.0|0.15|2.43|||||Stratified|||2.43|0.15|
73941816|NCT00902694|147415575|SUPERIORITY||Mean Difference (Net)|-4.6|||||TWO_SIDED|95.0|-13.1|3.9||||||18 month LDL chol intervention versus control||3.9|-13.1|
73941817|NCT00902694|147415575|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.9|1.7||||||6 month HDL chol intervention versus control||1.7|-2.9|
73941818|NCT00902694|147415575|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-1.8|3.1||||||18 month HDL intervention versus control||3.1|-1.8|
73941819|NCT00902694|147415575|SUPERIORITY||Mean Difference (Net)|-5.5|||||TWO_SIDED|95.0|-23.5|12.4||||||6 month TRIG intervention versus control||12.4|-23.5|
73941820|NCT00902694|147415575|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-27.0|23.9||||||18 month TRIG intervention versus control||23.9|-27.0|
73941821|NCT01024608|147415579|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.91|||<|0.001|TWO_SIDED|95.0|-1.3|-0.5||A priori threshold for statistical significance is p\<0.05.|ANCOVA|Repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.3|<0.001
73868359|NCT01115673|147281881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|469.37|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||<0.001
73868360|NCT01115673|147281881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|102.09||||0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||0.001
73868361|NCT01115673|147281881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|367.28|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||<0.001
73868362|NCT01115673|147281882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.7|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868363|NCT01115673|147281882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.14||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
73868364|NCT01115673|147281882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|178.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868365|NCT01115673|147281883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|242.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
74089170|NCT03575871|147731442|SUPERIORITY||Difference in LS mean|-20.9|||<|0.0001|TWO_SIDED|95.0|-26.6|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.1|-26.6|<0.0001
73868366|NCT01115673|147281883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.95||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
73868367|NCT01115673|147281883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|188.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
74089171|NCT03575871|147731442|SUPERIORITY||Difference in LS mean|-32.1|||<|0.0001|TWO_SIDED|95.0|-37.9|-26.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-26.4|-37.9|<0.0001
74089172|NCT03575871|147731442|SUPERIORITY||Difference in LS mean|-21.6|||<|0.0001|TWO_SIDED|95.0|-28.1|-15.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.2|-28.1|<0.0001
74089173|NCT03575871|147731442|SUPERIORITY||Difference in LS mean|-35.9|||<|0.0001|TWO_SIDED|95.0|-42.3|-29.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-29.4|-42.3|<0.0001
74089174|NCT03575871|147731442|SUPERIORITY||Difference in LS mean|-19.4|||<|0.0001|TWO_SIDED|95.0|-26.8|-12.1|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-12.1|-26.8|<0.0001
73868368|NCT01115673|147281884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.037||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.037
74089175|NCT03575871|147731442|SUPERIORITY||Difference in LS mean|-33.6|||<|0.0001|TWO_SIDED|95.0|-41.0|-26.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-26.3|-41.0|<0.0001
74089176|NCT03575871|147731442|SUPERIORITY||Difference in LS mean|-23.1|||<|0.0001|TWO_SIDED|95.0|-32.3|-13.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-13.9|-32.3|<0.0001
73868369|NCT01115673|147281884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.294||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.294
73868370|NCT01115673|147281884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66||||0.006||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.006
73868371|NCT01115673|147281885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.85|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868372|NCT01115673|147281885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.946||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.946
73868373|NCT01115673|147281885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868374|NCT01115673|147281886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868375|NCT01115673|147281886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.661||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.661
73868376|NCT01115673|147281886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.62|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868377|NCT01115673|147281887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
74031294|NCT02137772|147616052|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-23.5|||<|0.0001|TWO_SIDED|95.0|-32.5|-14.6||A 1-sided p-value ≤0.0249 for the risk difference was used for declaring statistical significance|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-14.6|-32.5|<0.0001
73868378|NCT01115673|147281887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.88||||0.13||95.0||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.13
73868379|NCT01115673|147281887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868380|NCT01115673|147281888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868381|NCT01115673|147281888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42||||0.041||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.041
73868382|NCT01115673|147281888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868383|NCT01115673|147281889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868384|NCT01115673|147281889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.34||||0.02||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.02
73868385|NCT01115673|147281889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.63|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868386|NCT01115673|147281890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.46|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868387|NCT01115673|147281890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.08||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
74031295|NCT02137772|147616053|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||||<0.0001
74031296|NCT02137772|147616054|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-31.3|||<|0.0001|TWO_SIDED|95.0|-39.9|-22.6||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-22.6|-39.9|<0.0001
73868388|NCT01115673|147281890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.38|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868389|NCT01115673|147281891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
74009000|NCT01641237|147568703|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.6||||0.0009|TWO_SIDED|95.0|2.35|8.86||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no dose-response relationship between %SMHR and fluoride concentration in the dentifrice.||8.86|2.35|0.0009
73868390|NCT01115673|147281891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.83||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
74031297|NCT02137772|147616055|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.4||||0.4056|TWO_SIDED|95.0|-4.0|3.2||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||3.2|-4.0|0.4056
73941822|NCT01024608|147415580|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.92|||<|0.001|TWO_SIDED|95.0|-1.3|-0.5||A priori threshold for statistical significance is p\<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.3|<0.001
73941823|NCT01024608|147415581|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.48||||0.005|TWO_SIDED|95.0|-0.8|-0.1||A priori threshold for statistical significance is p\<0.05|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||||-0.1|-0.8|0.005
73941824|NCT01024608|147415582|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.56||||0.002|TWO_SIDED|95.0|-0.9|-0.2||A priori threshold for statistical significance is p\<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction||||-0.2|-0.9|0.002
73941825|NCT05878197|147415640|OTHER|||||||0.024||||||Linear Mixed Models: time-effect|Mixed Models Analysis|||||||0.024
73941826|NCT05878197|147415640|OTHER|||||||0.822||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.822
74009001|NCT01641237|147568703|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.43||||0.0389|TWO_SIDED|95.0|0.18|6.68||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||6.68|0.18|0.0389
73868391|NCT01115673|147281891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.59|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73941827|NCT05878197|147415640|OTHER|||||||0.29||||||Linar mixed models: time\*group-effect|Mixed Models Analysis|||||||0.290
73941828|NCT05878197|147415640|OTHER||Mean Difference (Final Values)|1.8||||0.035|TWO_SIDED|95.0|0.1|3.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.4|0.1|0.035
73941829|NCT05878197|147415640|OTHER||Mean Difference (Final Values)|1.8||||0.038|TWO_SIDED|95.0|0.1|3.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.4|0.1|0.038
73941830|NCT05878197|147415640|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-1.9|1.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||1.9|-1.9|1.000
73941831|NCT05878197|147415641|OTHER|||||||0.107||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.107
73941832|NCT05878197|147415641|OTHER|||||||0.996||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.996
73941833|NCT05878197|147415641|OTHER|||||||0.639||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.639
73941834|NCT05878197|147415641|OTHER||Mean Difference (Final Values)|-0.1||||0.731|TWO_SIDED|95.0|-0.6|0.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.4|-0.6|0.731
73941835|NCT05878197|147415641|OTHER||Mean Difference (Final Values)|-0.4||||0.217|TWO_SIDED|95.0|-1.1|0.3||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.3|-1.1|0.217
73941836|NCT05878197|147415641|OTHER||Mean Difference (Final Values)|-0.3||||0.253|TWO_SIDED|95.0|-0.9|0.3||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.3|-0.9|0.253
73941837|NCT05878197|147415642|OTHER|||||||0.024||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.024
73941838|NCT05878197|147415642|OTHER|||||||0.449||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.449
73941839|NCT05878197|147415642|OTHER|||||||0.786||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.786
73941840|NCT05878197|147415642|OTHER||Mean Difference (Final Values)|-3.3||||0.099|TWO_SIDED|95.0|-7.2|0.7||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.7|-7.2|0.099
73941841|NCT05878197|147415642|OTHER||Mean Difference (Final Values)|-3.9||||0.074|TWO_SIDED|95.0|-8.3|0.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.4|-8.3|0.074
73941842|NCT05878197|147415642|OTHER||Mean Difference (Final Values)|-1.7||||0.472|TWO_SIDED|95.0|-6.7|3.2||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.2|-6.7|0.472
73941843|NCT05878197|147415643|OTHER|||||||0.115||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.115
73941844|NCT05878197|147415643|OTHER|||||||0.516||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.516
74031298|NCT02137772|147616056|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.0||||0.2258|TWO_SIDED|95.0|-3.5|1.5||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||1.5|-3.5|0.2258
74031299|NCT02137772|147616057|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-31.0|||<|0.0001|TWO_SIDED|95.0|-39.6|-22.4||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-22.4|-39.6|<0.0001
74031300|NCT02137772|147616058|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-23.3|||<|0.0001|TWO_SIDED|95.0|-32.3|-14.3||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-14.3|-32.3|<0.0001
74031301|NCT02137772|147616059|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||||<0.0001
74031302|NCT00803244|147616062|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.49||||0.2344||95.0|-1.3|0.32|||ANCOVA|||||0.32|-1.30|0.2344
74031303|NCT00803244|147616063|SUPERIORITY_OR_OTHER||LS Mean difference vs. Placebo|-0.09||||0.0401|TWO_SIDED|95.0|-0.18|0.0|||ANCOVA||Relative LS Means difference (%) = -19.7|||0.00|-0.18|0.0401
74031304|NCT02873715|147616067|SUPERIORITY||Mean Difference (Final Values)|-6.21|||<|0.05|TWO_SIDED|95.0|-10.14|-2.29|||ANCOVA||Results are pooled across 10 multiple imputations and reported as mean (standard error)|||-2.29|-10.14|<0.05
73868392|NCT01115673|147281892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73941845|NCT05878197|147415643|OTHER|||||||0.276||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.276
73941846|NCT05878197|147415643|OTHER||Mean Difference (Final Values)|-6.5||||0.025|TWO_SIDED|95.0|-12.2|-0.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||-0.9|-12.2|0.025
73941847|NCT05878197|147415643|OTHER||Mean Difference (Final Values)|-0.7||||0.794|TWO_SIDED|95.0|-6.4|4.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||4.9|-6.4|0.794
73941848|NCT05878197|147415643|OTHER||Mean Difference (Final Values)|-1.0||||0.76|TWO_SIDED|95.0|-7.7|5.7||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||5.7|-7.7|0.760
73941849|NCT02532179|147415671|SUPERIORITY||Mean Ratio|3.0|||<|0.001|TWO_SIDED|95.0|2.09|4.29||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||4.29|2.09|<0.001
73941850|NCT02532179|147415672|SUPERIORITY||Mean Ratio|3.82|||<|0.001|TWO_SIDED|95.0|2.77|5.25||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||5.25|2.77|<0.001
74009002|NCT01641237|147568703|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.86|||<|0.0001|TWO_SIDED|95.0|6.58|13.13||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||13.13|6.58|<0.0001
73941851|NCT02532179|147415673|SUPERIORITY||Mean Ratio|6.55|||<|0.001|TWO_SIDED|95.0|3.87|11.06||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||11.06|3.87|<0.001
73941852|NCT00876915|147415675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695||||0.4795|TWO_SIDED|95.0|0.235|1.89|||stratified Cox|||||1.890|0.235|0.4795
73941853|NCT00876915|147415676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.019||||0.0252|TWO_SIDED|95.0|1.236|131.632|||stratified Cox|||||131.632|1.236|0.0252
73941854|NCT04128293|147415692|OTHER||Ratio of Geometric Least Square Mean|0.877|||||TWO_SIDED|90.0|0.7585|1.0152|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-infinity).|||1.0152|0.7585|
73941855|NCT04128293|147415694|OTHER||Ratio of Geometric Least Square Mean|0.892|||||TWO_SIDED|90.0|0.7778|1.0239|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-t).|||1.0239|0.7778|
73941856|NCT04128293|147415696|OTHER||Ratio of Geometric Least Square Mean|0.946|||||TWO_SIDED|90.0|0.8594|1.0404|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of Cmax.|||1.0404|0.8594|
73941857|NCT04128293|147415699|OTHER||Median Difference (Final Values)|0.533||||0.4252|TWO_SIDED|90.0|-1.0|2.0||The p-value was assessed based on the Wilcoxon signed-rank test.|Wilcoxon signed-rank test||The median difference and the 90 percent (%) confidence interval of the median difference was estimated from Hodges-Lehmann estimate.|||2.0000|-1.0000|0.4252
73941858|NCT04128293|147415699|OTHER||Median Difference (Final Values)|1.0||||0.3125|TWO_SIDED|90.0|-0.75|5.25||The p-value was assessed based on the Wilcoxon rank sum test.|Wilcoxon rank sum test||The median difference and the 90% confidence interval of the median difference were estimated from Hodges-Lehmann estimate.|||5.2500|-0.7500|0.3125
73941859|NCT01490502|147415757|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
73941860|NCT01490502|147415757|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.57|TWO_SIDED|95.0|0.67|2.05|||Regression, Cox|||||2.05|0.67|0.57
73941861|NCT01490502|147415758|OTHER|||||||0.07|||||||Andersen Gill model for recurrent events|||||||0.07
73941862|NCT01490502|147415759|SUPERIORITY||Rate Ratio|1.8||||0.07|TWO_SIDED|95.0|0.94|3.45|||Negative Binomial Model|||||3.45|0.94|0.07
73941863|NCT01490502|147415760|SUPERIORITY||Rate Ratio|1.47||||0.14|TWO_SIDED|95.0|0.88|2.46|||Negative Binomial Model|||||2.46|0.88|0.14
73941864|NCT01490502|147415761|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
73941865|NCT01490502|147415762|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||The average rate of change in MSFC Z-score over time was analyzed using a linear mixed-effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in the MSFC Z-score between treatment arms.||||0.20
73941866|NCT01490502|147415763|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Rate of change in 2.5% low-contrast acuity was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in low-contrast acuity between treatment arms.||||0.67
73941867|NCT01490502|147415764|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||Rate of change in quality of life was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in health-related quality of life between treatment arms.||||0.21
74031305|NCT02873715|147616068|SUPERIORITY||Mean Difference (Final Values)|-3.97||||0.001|TWO_SIDED|95.0|-5.68|-2.26|||ANCOVA||Results are pooled across 10 multiple imputations and reported as mean (standard error)|||-2.26|-5.68|0.001
73941868|NCT01490502|147415765|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
73941869|NCT01490502|147415766|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
73868393|NCT01115673|147281892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73941870|NCT04186780|147415770|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters were normalized to logarithmic scale."|Mean Difference (Net)|2.5||||0.59|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group and intervention group in total cholesterol.|||||0.59
73941871|NCT04186780|147415771|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical and oxidative stress parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters and oxidative stress were normalized to logarithmic scale."|Mean Difference (Net)|0.4||||0.8284|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group and intervention group.|||||0.8284
73941872|NCT04186780|147415772|SUPERIORITY||Median Difference (Net)|0.1||||0.0058|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group compared to the intervention group.|||||0.0058
73974783|NCT00112359|147494979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.71||||0.0005|TWO_SIDED|95.0|4.31|15.11||"Primary endpoint analysis based on 2-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|ANCOVA model includes treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~A sample size of 70 participants per treatment group provided approximately 77% power to detect an 8-point difference in CFQ-R RSS score between treatment groups, assuming a standard deviation (SD) of 20 and a Type I error rate of 0.05."||15.11|4.31|0.0005
73974784|NCT00112359|147494980|SUPERIORITY_OR_OTHER|||||||0.064||0.0||||No adjustments were made for multiple comparisons.|Fisher Exact|Comparison by treatment group for proportion of participants hospitalized at least once between Day 0 and Day 42 (or 14 days after last study dose).||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants hospitalized at least once during the study.||||0.0640
74031306|NCT02873715|147616070|SUPERIORITY||Mean Difference (Final Values)|-0.5384||||0.65|TWO_SIDED||||||ANOVA|time x group analysis.||repeated measures analysis of variance for parent delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.||||0.65
73941873|NCT04186780|147415773|SUPERIORITY||Median Difference (Net)|0.8||||0.0384|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Reduced difference in TBARS in the placebo group compared to the intervention group at T66.|||||0.0384
73941874|NCT04186780|147415774|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical and oxidative stress parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters and oxidative stress were normalized to logarithmic scale."|Mean Difference (Net)|47.0||||0.0352|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between placebo group and intervention group of T66.|||||0.0352
73941875|NCT02066402|147415789|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance. Predefined margin for non-inferiority is -10%.|Difference of responder rate|-4.6||||0.2027|TWO_SIDED|95.0|-11.2|2.2|||Fisher Exact|||||2.2|-11.2|0.2027
73941876|NCT02066402|147415790|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||TWO_SIDED|95.0|-8.3|3.8||||||||3.8|-8.3|
73941877|NCT02066402|147415791|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.1|||||TWO_SIDED|95.0|-7.4|3.2||||||||3.2|-7.4|
73974785|NCT01988402|147494999|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5
74031307|NCT02873715|147616070|SUPERIORITY||Mean Difference (Net)|-0.3913||||0.87|TWO_SIDED|||||time x group analysis|ANOVA|||repeated measures analysis of variance for child delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.||||0.87
73941878|NCT02066402|147415792|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||TWO_SIDED|95.0|-8.6|4.1||||||||4.1|-8.6|
73941879|NCT02066402|147415793|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-3.1|||||TWO_SIDED|95.0|-8.4|2.0||||||||2.0|-8.4|
73941880|NCT00152464|147415800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.002|||=|0.991|TWO_SIDED|95.0|0.75|1.338|||Regression, Cox|||||1.338|0.750|=0.991
73974786|NCT01961609|147495003|SUPERIORITY_OR_OTHER||Percentage|65.3|||<|0.0001|TWO_SIDED|99.375|52.4|76.7|||two-sided binomial exact test||A Bonferroni adjustment adjusting for 8 analyses have been applied.|||76.7|52.4|<0.0001
73868394|NCT01115673|147281892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868395|NCT01115673|147281893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.04|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868396|NCT01115673|147281893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868397|NCT01115673|147281893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73941881|NCT04493931|147415812|OTHER||Ratio of Geometric LS Mean|0.944|||||TWO_SIDED|90.0|0.753|1.184||||||||1.184|0.753|
73941882|NCT04493931|147415813|OTHER||Median Difference (Final Values)|-0.25|||||TWO_SIDED|90.0|-0.75|0.742|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.742|-0.750|
73941883|NCT04493931|147415814|OTHER||Ratio of Geometric LS Mean|1.094|||||TWO_SIDED|90.0|0.959|1.249||||||||1.249|0.959|
73941884|NCT04493931|147415815|OTHER||Ratio of Geometric LS Mean|1.157|||||TWO_SIDED|90.0|1.059|1.265||||||||1.265|1.059|
74089177|NCT03575871|147731442|SUPERIORITY||Difference in LS mean|-33.4|||<|0.0001|TWO_SIDED|95.0|-42.6|-24.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-24.3|-42.6|<0.0001
73868398|NCT01115673|147281894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868399|NCT01115673|147281894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.58||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
73868400|NCT01115673|147281894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868401|NCT01115673|147281895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35||||0.028||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.028
73868402|NCT01115673|147281895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.462||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.462
73868403|NCT01115673|147281895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48||||0.008||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.008
73941885|NCT04493931|147415816|OTHER||Ratio of Geometric LS Mean|1.158|||||TWO_SIDED|90.0|1.062|1.264||||||||1.264|1.062|
73941886|NCT04493931|147415817|OTHER||Ratio of Geometric LS Mean|0.73|||||TWO_SIDED|90.0|0.635|0.84||||||||0.840|0.635|
73941887|NCT04493931|147415818|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
73941888|NCT04493931|147415819|OTHER||Median Difference (Final Values)|-0.467|||||TWO_SIDED|90.0|-1.0|0.492|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate|||0.492|-1.000|
73941889|NCT04493931|147415820|OTHER||Ratio of Geometric LS Mean|0.476|||||TWO_SIDED|90.0|0.433|0.525||||||||0.525|0.433|
74089178|NCT01045993|147731443|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.||||||0.046
73941890|NCT04493931|147415821|OTHER||Ratio of Geometric LS Mean|0.478|||||TWO_SIDED|90.0|0.435|0.526||||||||0.526|0.435|
73941891|NCT04493931|147415822|OTHER||Ratio of Geometric LS mean|1.533|||||TWO_SIDED|90.0|1.274|1.845||||||||1.845|1.274|
73941892|NCT04493931|147415823|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
73941893|NCT04493931|147415824|OTHER||Median Difference (Final Values)|-0.5|||||TWO_SIDED|90.0|-1.0|-0.233|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||-0.233|-1.000|
73941894|NCT04493931|147415825|OTHER||Ratio of Geometric LS mean|1.217|||||TWO_SIDED|90.0|1.085|1.363||||||||1.363|1.085|
73941895|NCT04493931|147415826|OTHER||Ratio of Geometric LS mean|1.121|||||TWO_SIDED|90.0|0.983|1.278||||||||1.278|0.983|
73941896|NCT04493931|147415827|OTHER||Ratio of Geometric LS mean|1.242|||||TWO_SIDED|90.0|1.046|1.475||||||||1.475|1.046|
73941897|NCT04493931|147415828|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
73941898|NCT04493931|147415829|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.25|0.8|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.800|-0.250|
73941899|NCT04493931|147415830|OTHER||Ratio of Geometric LS mean|1.923|||||TWO_SIDED|90.0|1.622|2.278||||||||2.278|1.622|
73941900|NCT04493931|147415831|OTHER||Ratio of Geometric LS mean|1.902|||||TWO_SIDED|90.0|1.619|2.234||||||||2.234|1.619|
73941901|NCT04493931|147415855|OTHER||Ratio of geometric LS mean|1.051|||||TWO_SIDED|90.0|0.824|1.34||||||||1.340|0.824|
73868404|NCT01115673|147281896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.81|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868405|NCT01115673|147281896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.907||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.907
73868406|NCT01115673|147281896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.11|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868407|NCT01115673|147281897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.19|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868408|NCT01115673|147281897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.655||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.655
73868409|NCT01115673|147281897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868410|NCT01115673|147281898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.15|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868411|NCT01115673|147281898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||0.155||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.155
73941902|NCT04493931|147415856|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.25|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.250|0.000|
73941903|NCT04493931|147415857|OTHER||Median Difference (Final Values)|0.5|||||TWO_SIDED|90.0|-0.5|1.25|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||1.250|-0.500|
73868412|NCT01115673|147281898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868413|NCT01115673|147281899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.69|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868414|NCT01115673|147281899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.04||||0.05||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.05
73868415|NCT01115673|147281899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868416|NCT01115673|147281900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.83|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
74039432|NCT04847141|147632425|SUPERIORITY||Difference in Percentage|0.02||||0.9853|TWO_SIDED|95.0|-3.05|3.12||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants with critical COVID-19 illness between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||3.12|-3.05|0.9853
73941904|NCT04493931|147415858|OTHER||Ratio of geometric LS mean|1.094|||||TWO_SIDED|90.0|0.987|1.212||||||||1.212|0.987|
73941905|NCT04493931|147415859|OTHER||Ratio of geometric LS mean|1.095|||||TWO_SIDED|90.0|0.991|1.209||||||||1.209|0.991|
73941906|NCT04493931|147415862|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.25|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|-0.250|
73868417|NCT01115673|147281900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.74||||0.032||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.032
73941907|NCT04493931|147415865|OTHER||Ratio of geometric LS mean|1.214|||||TWO_SIDED|90.0|1.0|1.473||||||||1.473|1.000|
73941908|NCT04493931|147415866|OTHER||Ratio of geometric LS mean|1.097|||||TWO_SIDED|90.0|0.948|1.27||||||||1.270|0.948|
73941909|NCT04493931|147415867|OTHER||Ratio of geometric LS mean|1.071|||||TWO_SIDED|90.0|0.939|1.221||||||||1.221|0.939|
73941910|NCT04493931|147415868|OTHER||Ratio of geometric LS mean|1.096|||||TWO_SIDED|90.0|0.93|1.292||||||||1.292|0.930|
73941911|NCT04493931|147415882|OTHER||Ratio of geometric LS mean|0.499|||||TWO_SIDED|90.0|0.441|0.565||||||||0.565|0.441|
73941912|NCT04493931|147415883|OTHER||Ratio of geometric LS mean|0.439|||||TWO_SIDED|90.0|0.37|0.521||||||||0.521|0.370|
73941913|NCT04493931|147415884|OTHER||Ratio of geometric LS mean|0.438|||||TWO_SIDED|90.0|0.372|0.516||||||||0.516|0.372|
73941914|NCT04493931|147415885|OTHER||Ratio of geometric LS mean|1.036|||||TWO_SIDED|90.0|0.95|1.129||||||||1.129|0.950|
73941915|NCT04493931|147415909|OTHER||Ratio of Geometric LS mean|1.755|||||TWO_SIDED|90.0|1.304|2.363||||||||2.363|1.304|
73941916|NCT04493931|147415910|OTHER||Ratio of Geometric LS mean|0.833|||||TWO_SIDED|90.0|0.769|0.902||||||||0.902|0.769|
73941917|NCT04493931|147415911|OTHER||Ratio of Geometric LS mean|0.745|||||TWO_SIDED|90.0|0.653|0.85||||||||0.850|0.653|
73941918|NCT04493931|147415912|OTHER||Ratio of Geometric LS mean|0.892|||||TWO_SIDED|90.0|0.782|1.018||||||||1.018|0.782|
73941919|NCT04493931|147415913|OTHER||Ratio of Geometric LS mean|1.157|||||TWO_SIDED|90.0|0.876|1.528||||||||1.528|0.876|
73941920|NCT04493931|147415914|OTHER||Ratio of Geometric LS mean|1.142|||||TWO_SIDED|90.0|1.016|1.283||||||||1.283|1.016|
73941921|NCT04493931|147415915|OTHER||Ratio of Geometric LS mean|0.603|||||TWO_SIDED|90.0|0.521|0.699||||||||0.699|0.521|
73868418|NCT01115673|147281900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73941922|NCT04493931|147415916|OTHER||Ratio of Geometric LS mean|0.526|||||TWO_SIDED|90.0|0.448|0.618||||||||0.618|0.448|
73941923|NCT00430248|147415952|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of febuxostat 40 mg to allopurinol was declared if the value of the lower bound of the 95% confidence interval for the difference was greater than -10%.|Difference in percentage|3.1||||||95.0|-1.9|8.1||||||The primary comparison was between febuxostat 40 mg and allopurinol treatment groups.||8.1|-1.9|
73941924|NCT00430248|147415952|SUPERIORITY_OR_OTHER|||||||0.233||95.0||||The test for superiority was performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||||0.233
73941925|NCT00430248|147415952|SUPERIORITY_OR_OTHER||Difference in percentage|24.9|||<|0.001||95.0|20.1|29.8||Comparisons between treatment groups were performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||29.8|20.1|<0.001
73941926|NCT00430248|147415952|SUPERIORITY_OR_OTHER||Difference in percentage|21.9|||<|0.001||95.0|17.0|26.8||Comparisons between treatment groups were performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||26.8|17.0|<0.001
73941927|NCT00430248|147415953|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.021
73941928|NCT00430248|147415953|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941929|NCT00430248|147415953|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941930|NCT00430248|147415954|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.031
73941931|NCT00430248|147415954|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941932|NCT00430248|147415954|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941933|NCT00430248|147415955|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.578
73941934|NCT00430248|147415955|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941935|NCT00430248|147415955|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941936|NCT00430248|147415956|SUPERIORITY_OR_OTHER|||||||0.426||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.426
73941937|NCT00430248|147415956|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941938|NCT00430248|147415956|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941939|NCT00430248|147415957|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.050
74031308|NCT00418262|147616133|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.21|0.3|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.30|-0.21|
74031309|NCT00418262|147616133|SUPERIORITY||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.42|0.6|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.60|-0.42|
74031310|NCT00418262|147616134|SUPERIORITY||Mean Difference (Net)|0.12|||||TWO_SIDED|95.0|-0.11|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.39|-0.11|
74031311|NCT00418262|147616134|SUPERIORITY||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.23|0.77|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.77|-0.23|
74031312|NCT00418262|147616135|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.36|-0.17|
74031313|NCT00418262|147616135|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.36|-0.17|
74031314|NCT00418262|147616136|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.40|-0.16|
74031315|NCT00418262|147616136|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.40|-0.16|
74031316|NCT00418262|147616137|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.18|-0.36|
73868419|NCT01115673|147281901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.36|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
74031317|NCT00418262|147616137|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.18|-0.36|
74031318|NCT00418262|147616138|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.20|
74031319|NCT00418262|147616138|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.20|
74031320|NCT00418262|147616139|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.24|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.24|-0.24|
74031321|NCT00418262|147616139|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.49|0.49|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.49|-0.49|
74039433|NCT04847141|147632425|SUPERIORITY||Difference in Percentage|0.01||||0.989|TWO_SIDED|95.0|-2.99|3.07||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants with critical COVID-19 illness between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||3.07|-2.99|0.9890
73868420|NCT01115673|147281901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.52||||0.003||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.003
73941940|NCT00430248|147415957|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941941|NCT00430248|147415957|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941942|NCT00430248|147415958|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.428
73974787|NCT03500549|147495028|SUPERIORITY|The primary endpoint analysis was a between-treatment-group comparison using a mixed effect model for repeated measures (MMRM). The difference between pegcetacoplan and eculizumab LS mean Hb changes from Baseline at Week 16 was calculated along with its 2-sided 95% confidence interval (CI) and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|3.84|||<|0.0001|TWO_SIDED|95.0|2.33|5.34||Superiority was tested at the 5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||5.34|2.33|<0.0001
73974788|NCT03500549|147495029|NON_INFERIORITY|Analysis was based on prespecified non-inferiority margins (NIM) and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of -20%. Stratified Cochran-Mantel Haenszel (CMH) chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified (Miettinen-Nurminen) method.|Risk Difference (RD)|0.6253|||<|0.0001|TWO_SIDED|95.0|0.483|0.7677||Non-inferiority was tested at the 2.5% level.|Miettinen-Nurminen|||||0.7677|0.4830|<0.0001
73941943|NCT00430248|147415958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941944|NCT00430248|147415958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941945|NCT00430248|147415959|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.041
73941946|NCT00430248|147415959|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941947|NCT00430248|147415959|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941948|NCT00430248|147415960|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.083
73941949|NCT00430248|147415960|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941950|NCT00430248|147415960|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941951|NCT00430248|147415961|SUPERIORITY_OR_OTHER|||||||0.421||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.421
73868421|NCT01115673|147281901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868422|NCT01115673|147281902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868423|NCT01115673|147281902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.04||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
73868424|NCT01115673|147281902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.75|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868425|NCT01115673|147281903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868426|NCT01115673|147281903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868427|NCT01115673|147281903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.02|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868428|NCT01115673|147281904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.4|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868429|NCT01115673|147281904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868430|NCT01115673|147281904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868431|NCT01115673|147281905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868432|NCT01115673|147281905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
73868433|NCT01115673|147281905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868434|NCT01115673|147281906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.65||||0.027||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.027
73868435|NCT01115673|147281906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.49||||0.365||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.365
73868436|NCT01115673|147281906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.14||||0.005||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.005
73868437|NCT01115673|147281907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868438|NCT01115673|147281907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.923||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.923
73868439|NCT01115673|147281907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868440|NCT01115673|147281908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868441|NCT01115673|147281908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38||||0.653||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.653
74009003|NCT01641237|147568703|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.68|||<|0.0001|TWO_SIDED|95.0|4.41|10.96||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||10.96|4.41|<0.0001
73868442|NCT01115673|147281908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73941952|NCT00430248|147415961|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941953|NCT00430248|147415961|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941954|NCT00430248|147415962|SUPERIORITY_OR_OTHER|||||||0.52||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.520
73941955|NCT00430248|147415962|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941956|NCT00430248|147415962|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941957|NCT00430248|147415963|SUPERIORITY_OR_OTHER|||||||0.195||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.195
73941958|NCT00430248|147415963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73868443|NCT01115673|147281909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.71|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73941959|NCT00430248|147415963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941960|NCT00430248|147415964|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.196
73941961|NCT00430248|147415964|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941962|NCT00430248|147415964|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
73941963|NCT00430248|147415965|SUPERIORITY_OR_OTHER|||||||0.079||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.079
73941964|NCT00430248|147415965|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
73941965|NCT00430248|147415965|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
73941966|NCT00430248|147415966|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.685
73941967|NCT00430248|147415966|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
73941968|NCT00430248|147415966|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
73941969|NCT00430248|147415967|SUPERIORITY_OR_OTHER|||||||0.153||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.153
73941970|NCT00430248|147415967|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
73941971|NCT00430248|147415967|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
73941972|NCT00430248|147415968|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.050
73941973|NCT00430248|147415968|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
73941974|NCT00430248|147415968|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
73941975|NCT01624948|147415969|SUPERIORITY_OR_OTHER|||||||0.53|||||||Fisher Exact|||||||0.53
73941976|NCT01624948|147415971|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Difference in p70S6 kinase phosphorylation as measured by mean fluorescence intensity (MFI) between those patients who reached the primary endpoint and those who did not||||0.67
73941977|NCT01624948|147415972|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73941978|NCT01624948|147415974|SUPERIORITY_OR_OTHER|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
73941979|NCT03387579|147415975|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.590
73941980|NCT03387579|147415975|SUPERIORITY|||||||0.224|||||||Fisher Exact|||||||0.224
73941981|NCT03387579|147415975|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73941982|NCT03387579|147415976|SUPERIORITY|||||||0.471|||||||Kruskal-Wallis|||||||0.471
73941983|NCT03387579|147415977|SUPERIORITY|||||||0.525|||||||Kruskal-Wallis|||||||0.525
73941984|NCT03387579|147415978|SUPERIORITY|||||||0.753|||||||Kruskal-Wallis|||||||0.753
73941985|NCT03387579|147415979|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
73941986|NCT03387579|147415980|SUPERIORITY|||||||0.127|||||||Fisher Exact|||||||0.127
73941987|NCT03387579|147415981|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73868444|NCT01115673|147281909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.21||||0.138||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.138
73941988|NCT03387579|147415982|SUPERIORITY||estimate|8.553||||0.046|TWO_SIDED|||||Intralipid 20% reduction versus smoflipid 20%|Mixed Models Analysis||standard error 4.249|||||0.046
73941989|NCT03387579|147415982|SUPERIORITY||estimate|7.023||||0.04|TWO_SIDED|||||Intralipid 20% historic versus smoflipid|Mixed Models Analysis||standard error 3.376|||||0.040
73941990|NCT03387579|147415982|SUPERIORITY||estimate|-1.53||||0.718|TWO_SIDED|||||Intralipid 20% Historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 4.231|||||0.718
73941991|NCT03387579|147415983|SUPERIORITY||estimate|13.436||||0.003|TWO_SIDED|||||Intralipid 20% reduction versus Smoflipid 20%|Mixed Models Analysis||standard error 4.440|||||0.003
73941992|NCT03387579|147415983|SUPERIORITY||estimate|3.936||||0.27|TWO_SIDED|||||Intralipid 20% historic versus Smoflipid 20%|Mixed Models Analysis||standard error 3.553|||||0.270
73941993|NCT03387579|147415983|SUPERIORITY||estimate|-9.5||||0.034|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 4.416|||||0.034
73941994|NCT03387579|147415984|SUPERIORITY||estimate|42.674||||0.006|TWO_SIDED|||||Intralipid 20% reduction versus Smoflipid 20%|Mixed Models Analysis||standard error 15.216|||||0.006
73974789|NCT03500549|147495030|NON_INFERIORITY|Analysis was based on prespecified NIM and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of 10.|LS mean difference|-163.61|||<|0.0001|TWO_SIDED|95.0|-189.91|-137.3||Non-inferiority was tested at the 2.5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-137.30|-189.91|<0.0001
73941995|NCT03387579|147415984|SUPERIORITY||estimate|11.117||||0.305|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 10.771|||||0.305
73941996|NCT03387579|147415984|SUPERIORITY||estimate|-31.557|||<|0.001|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 67.673|||||<0.001
73941997|NCT03387579|147415985|SUPERIORITY||estimate|-0.593||||0.835|TWO_SIDED|||||Intralipid 20% reduction versus smoflipid 20%|Mixed Models Analysis||standard error 2.848|||||0.835
73941998|NCT03387579|147415985|SUPERIORITY||estimate|-0.522||||0.799|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 2.050|||||0.799
73941999|NCT03387579|147415985|SUPERIORITY||estimate|0.714||||0.714|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 2.758|||||0.714
73942000|NCT03387579|147415986|SUPERIORITY||estimate|11.162||||0.379|TWO_SIDED||||||Mixed Models Analysis|Intralipid 20% reduction versus smoflipid 20%|standard error 12.626|||||0.379
73942001|NCT03387579|147415986|SUPERIORITY||estimate|3.853||||0.717|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 10.615|||||0.717
73942002|NCT03387579|147415986|SUPERIORITY|Intralipid 20% historic versus intralipid 20% reduction|estimate|-7.31||||0.576|TWO_SIDED||||||Mixed Models Analysis||standard error 13.025|||||0.576
73942003|NCT03387579|147415987|SUPERIORITY|||||||1|||||||Fisher Exact|||ROP||||1.00
73942004|NCT03387579|147415987|SUPERIORITY|||||||1|||||||Fisher Exact|||ROP||||1.00
73942005|NCT03387579|147415988|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73942006|NCT03387579|147415988|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.640
73942007|NCT03387579|147415988|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73942008|NCT03387579|147415989|SUPERIORITY|||||||0.211|||||||Kruskal-Wallis|||||||0.211
73942009|NCT03387579|147415990|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.720
73942010|NCT03387579|147415991|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
73942011|NCT03387579|147415992|SUPERIORITY|||||||0.774|||||||t-test, 2 sided|||||||0.774
73942012|NCT03387579|147415993|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
73942013|NCT03387579|147415994|SUPERIORITY|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||||||0.475
73942014|NCT05120115|147416026|EQUIVALENCE|Examined differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|ANOVA|||||||0.05
73942015|NCT05120115|147416027|EQUIVALENCE|Differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|Mixed Models Analysis|||||||0.05
73942016|NCT05120115|147416028|EQUIVALENCE|Differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|Mixed Models Analysis|||||||0.05
73942017|NCT01113502|147416029|OTHER||Maximum Tolerated Dose (mg)|300.0|||||TWO_SIDED|||||||||||||
73942018|NCT01274182|147416044|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.106|||||TWO_SIDED|90.0|1.01|1.21|||||GP2013 arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.210|1.010|
73974790|NCT03500549|147495031|NON_INFERIORITY|Analysis was based on prespecified NIM and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of 20.|LS mean difference|-4.63||||0.9557|TWO_SIDED|95.0|-181.3|172.04||Non-inferiority was tested at the 2.5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||172.04|-181.30|0.9557
73868445|NCT01115673|147281909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73942019|NCT01274182|147416044|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.012|||||TWO_SIDED|90.0|0.925|1.108|||||GP2013 arm is the numerator and Rituxan arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.108|0.925|
73974791|NCT03500549|147495032|OTHER|Non-inferiority was not assessed because of the prespecified hierarchical testing. Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|11.87||||0.0005|TWO_SIDED|95.0|5.49|18.25||MRMM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||18.25|5.49|0.0005
73942020|NCT01274182|147416044|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.093|||||TWO_SIDED|90.0|0.989|1.208|||||Rituxan arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.208|0.989|
73942021|NCT01274182|147416045|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.076|||||TWO_SIDED|90.0|0.979|1.184|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.||1.184|0.979|
73942022|NCT01274182|147416045|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.131|||||TWO_SIDED|90.0|1.027|1.244|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25||1.244|1.027|
73974792|NCT03500549|147495033|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.6745|||||TWO_SIDED|95.0|0.5452|0.8039|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.8039|0.5452|
73974793|NCT03500549|147495034|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.6639|||||TWO_SIDED|95.0|0.5309|0.7968|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.7968|0.5309|
73974794|NCT03500549|147495035|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.3043|||||TWO_SIDED|95.0|0.1493|0.4593|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.4593|0.1493|
73974795|NCT03500549|147495036|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-21.93||||0.0002|TWO_SIDED|95.0|-32.49|-11.36||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-11.36|-32.49|0.0002
73868446|NCT01115673|147281910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|93.66|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868447|NCT01115673|147281910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.46||||0.043||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.043
73974796|NCT03500549|147495037|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-0.14||||0.0369|TWO_SIDED|95.0|-0.28|-0.01||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-0.01|-0.28|0.0369
73868448|NCT01115673|147281910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|82.2|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868449|NCT01115673|147281911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|94.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73942023|NCT01274182|147416045|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.946|1.167|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.||1.167|0.946|
73868450|NCT01115673|147281911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.08||||0.024||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.024
73942024|NCT01274182|147416046|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|0.989|||||TWO_SIDED|95.0|0.974|1.004|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25||1.004|0.974|
73942025|NCT01274182|147416046|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.021|||||TWO_SIDED|95.0|1.003|1.04|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25||1.040|1.003|
73942026|NCT01274182|147416046|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.033|||||TWO_SIDED|95.0|1.016|1.05|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalence limits of 0.8-1.25||1.050|1.016|
73942027|NCT01274182|147416047|NON_INFERIORITY|"The non-inferiority margin is further justified by the EULAR criteria which define no response as change from baseline being \< 0.6.~LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment\*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-0.397|0.24|||||The direction of comparison is LS mean of GP2013 - LS mean of Rituxan|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.||0.240|-0.397|
73868451|NCT01115673|147281911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73974797|NCT03500549|147495038|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|59.1||||0.0069|TWO_SIDED|95.0|16.88|101.32||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||101.32|16.88|0.0069
73974798|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|18.62||||0.0486|TWO_SIDED|95.0|0.12|37.13||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Global Health Status/QoL: Difference in LS mean||37.13|0.12|0.0486
73868452|NCT01115673|147281912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868453|NCT01115673|147281912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
73942028|NCT01274182|147416047|NON_INFERIORITY|"The non-inferiority margin is further justified by the EULAR criteria which define no response as change from baseline being \< 0.6. LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment\*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.201|||TWO_SIDED|95.0|-0.328|0.462|||||The direction of comparison is LS mean of GP2013 Part I - LS mean of MabThera|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.||0.462|-0.328|
73942029|NCT01274182|147416048|NON_INFERIORITY|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|9.77|STANDARD_ERROR_OF_MEAN|6.79|||TWO_SIDED|95.0|-3.54|23.08|||||The direction of comparison is response rate of GP2013 - response rate of Rituxan|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.||23.08|-3.54|
73942030|NCT01274182|147416048|NON_INFERIORITY|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|-0.57|STANDARD_ERROR_OF_MEAN|7.23|||TWO_SIDED|95.0|-14.74|13.6|||||The direction of comparison is response rate of GP2013 Part I - response rate of MabThera|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.||13.60|-14.74|
73974799|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|12.86||||0.0023|TWO_SIDED|95.0|4.86|20.86||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Physical functioning: Difference in LS mean||20.86|4.86|0.0023
73868454|NCT01115673|147281912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.23|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73942031|NCT00420992|147416066|SUPERIORITY_OR_OTHER|||||||0.0445||95.0||||Threshold for statistical significance: P=0.05. No adjustment for multiple comparisons necessary.|ANCOVA|Model included treatment as factor and baseline pain score as covariate.||Null hypothesis: mean change from baseline is the same for ALO-01 and placebo.||||0.0445
73942032|NCT03882879|147416072|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
73942033|NCT03882879|147416073|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
73942034|NCT03882879|147416074|SUPERIORITY|||||||0.76||||||Between-group two-sided t-test|t-test, 2 sided|||||||0.76
73974800|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|24.43||||0.0027|TWO_SIDED|95.0|8.84|40.01||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Role functioning: Difference in LS mean||40.01|8.84|0.0027
73942035|NCT03882879|147416075|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
73942036|NCT03882879|147416076|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
73942037|NCT03923959|147416091|SUPERIORITY||Odds Ratio (OR)|1.013|STANDARD_ERROR_OF_MEAN|0.307||0.966|TWO_SIDED|95.0|0.5597|1.834|||Regression, Logistic||||A two-sample proportion test was also completed; the test utilized an α \< 0.049 to account for the O'Brien-Fleming adjustment. The p-value for the two-sample proportion test was 0.966.|1.834|0.5597|0.966
73942038|NCT03923959|147416092|SUPERIORITY|||||||0.183||||||a priori threshold for statistical significance was the standard α = 0.05.|Chi-squared|||||||0.183
73868455|NCT01115673|147281913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73942039|NCT03923959|147416093|SUPERIORITY|||||||0.729||||||a priori threshold for statistical significance was the standard α = 0.05.|Chi-squared|||||||0.729
73942040|NCT03923959|147416094|SUPERIORITY|||||||0.655||||||a priori threshold for statistical significance was the standard α = 0.05|Chi-squared|||||||0.655
73942041|NCT03923959|147416095|SUPERIORITY|||||||0.7832||||||a priori threshold for statistical significance was the standard α = 0.05.|t-test, 2 sided|||||||0.7832
73942042|NCT02954354|147416123|SUPERIORITY||Difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-35.8|-17.8||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||The primary analysis of time to alleviation of symptoms was a comparison of baloxavir with placebo in all participants in the intention-to-treat infection population. Statistical tests were performed at the 0.05 significance level.||-17.8|-35.8|<0.0001
73942043|NCT02954354|147416123|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||<0.0001
73942044|NCT02954354|147416124|SUPERIORITY||Difference|-0.3||||0.756|TWO_SIDED|95.0|-6.6|6.6||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||A secondary analysis of time to alleviation of symptoms, consisting of a comparison between the 20 to 64 years of age stratum of the baloxavir group and the oseltamivir group, was conducted if statistical significance was observed in the primary analysis in order to maintain the overall Type I error.||6.6|-6.6|0.7560
73942045|NCT02954354|147416124|SUPERIORITY|||||||0.3761||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.3761
73942046|NCT02954354|147416125|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
73942047|NCT02954354|147416125|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
73974801|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|4.11||||0.6013|TWO_SIDED|95.0|-11.58|19.8||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Emotional functioning: Difference in LS mean||19.80|-11.58|0.6013
73974802|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|9.56||||0.1792|TWO_SIDED|95.0|-4.52|23.64||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Cognitive functioning: Difference in LS mean||23.64|-4.52|0.1792
73942048|NCT02954354|147416125|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||<0.0001
73942049|NCT02954354|147416125|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||<0.0001
73942050|NCT02954354|147416125|SUPERIORITY|||||||0.4767||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.4767
73942051|NCT02954354|147416125|SUPERIORITY|||||||0.3353||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.3353
74039434|NCT02215616|147632428|OTHER||Least square (LS) mean difference|0.78||||0.4853|TWO_SIDED|95.0|-1.42|2.98||Threshold for significance at 0.045 level.|Mixed Models Analysis|||Analysis was performed using Mixed Model Repeated Measures model (MMRM) with treatment group (3 levels: placebo, laquinimod 0.5 mg and laquinimod 1 mg), categorical week (4 levels: Weeks 4, 13, 26, and 52), treatment by week interaction, country, TMS baseline value and TMS baseline by week interaction as fixed effects. Unstructured variance-covariance structure was used in the initial model.||2.98|-1.42|0.4853
73942052|NCT02954354|147416126|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
73942053|NCT02954354|147416126|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
73942054|NCT02954354|147416126|SUPERIORITY|||||||0.0852||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.0852
73974803|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|11.27||||0.1039|TWO_SIDED|95.0|-2.38|24.92||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Social functioning: Difference in LS mean||24.92|-2.38|0.1039
73868456|NCT01115673|147281913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.87||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
73942055|NCT02954354|147416126|SUPERIORITY|||||||0.0063||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0063
73942056|NCT02954354|147416126|SUPERIORITY|||||||0.6187||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.6187
73942057|NCT02954354|147416126|SUPERIORITY|||||||0.8637||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|||Day 9||||0.8637
73974804|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-20.74||||0.0062|TWO_SIDED|95.0|-35.29|-6.19||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Fatigue: Difference in LS mean||-6.19|-35.29|0.0062
73942058|NCT02954354|147416127|SUPERIORITY|||||||0.6145||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||0.6145
73942059|NCT02954354|147416127|SUPERIORITY|||||||0.2505||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||0.2505
73868457|NCT01115673|147281913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868458|NCT01115673|147281914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868459|NCT01115673|147281914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868460|NCT01115673|147281914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868461|NCT01115673|147281915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868462|NCT01115673|147281915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868463|NCT01115673|147281915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73942060|NCT02954354|147416127|SUPERIORITY|||||||0.419||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.4190
73868464|NCT01115673|147281916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868465|NCT01115673|147281916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.98||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
73868466|NCT01115673|147281916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.41|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73974805|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-0.01||||0.9975|TWO_SIDED|95.0|-8.38|8.35||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Nausea and vomiting: Difference in LS mean||8.35|-8.38|0.9975
73868467|NCT01115673|147281917|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868468|NCT01115673|147281917|SUPERIORITY_OR_OTHER|||||||0.26||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.26
73868469|NCT01115673|147281917|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868470|NCT01115673|147281918|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868471|NCT01115673|147281918|SUPERIORITY_OR_OTHER|||||||0.934||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.934
73942061|NCT02954354|147416127|SUPERIORITY|||||||0.0095||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0095
74039435|NCT02528253|147632440|SUPERIORITY||Least Square (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1117|TWO_SIDED|95.0|-0.66|0.07|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.||0.07|-0.66|0.1117
73868472|NCT01115673|147281918|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73942062|NCT02954354|147416127|SUPERIORITY|||||||0.7393||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.7393
73942063|NCT02954354|147416127|SUPERIORITY|||||||0.0049||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.0049
73942064|NCT02954354|147416128|SUPERIORITY|||||||0.2266||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||0.2266
73942065|NCT02954354|147416128|SUPERIORITY|||||||0.1379||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||0.1379
73942066|NCT02954354|147416128|SUPERIORITY|||||||0.5479||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.5479
73942067|NCT02954354|147416128|SUPERIORITY|||||||0.0241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0241
73942068|NCT02954354|147416128|SUPERIORITY|||||||0.0898||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.0898
73942069|NCT02954354|147416128|SUPERIORITY|||||||0.2548||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.2548
73942070|NCT02954354|147416129|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
73942071|NCT02954354|147416129|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
73942072|NCT02954354|147416129|SUPERIORITY|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.0008
73942073|NCT02954354|147416129|SUPERIORITY|||||||0.0132||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0132
73942074|NCT02954354|147416129|SUPERIORITY|||||||0.9307||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.9307
73942075|NCT02954354|147416129|SUPERIORITY|||||||0.1677||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.1677
73942076|NCT02954354|147416130|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
73942077|NCT02954354|147416130|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
73942078|NCT02954354|147416130|SUPERIORITY|||||||0.801||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.8010
73942079|NCT02954354|147416130|SUPERIORITY|||||||0.9451||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.9451
73942080|NCT02954354|147416130|SUPERIORITY|||||||0.2256||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.2256
73942081|NCT02954354|147416130|SUPERIORITY|||||||0.3332||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.3332
73942082|NCT02954354|147416131|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
73868473|NCT01115673|147281919|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
73868474|NCT01115673|147281919|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
73868475|NCT01115673|147281919|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
73868476|NCT01115673|147281920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.06|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868477|NCT01115673|147281920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.002||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
73868478|NCT01115673|147281920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868479|NCT01115673|147281921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868480|NCT01115673|147281921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868481|NCT01115673|147281921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868482|NCT01115673|147281922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|18.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73942083|NCT02954354|147416131|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
73974806|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-2.76||||0.7554|TWO_SIDED|95.0|-20.36|14.85||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Pain: Difference in LS mean||14.85|-20.36|0.7554
73868483|NCT01115673|147281922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.006||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.006
73868484|NCT01115673|147281922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.16|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868485|NCT01115673|147281923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868486|NCT01115673|147281923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
73868487|NCT01115673|147281923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73868488|NCT01593592|147281927|SUPERIORITY_OR_OTHER||percentage|0.0|||||TWO_SIDED|95.0||||||||A total of 70 patients were included; 35 in each arm. The sample size was calculated assuming eradication of H. pylori in at least 70% of treated patients, aiming to detect a difference of 30% based on a 0.80 power to detect significant difference (p =0.05, two-sided).||||
73942084|NCT02954354|147416131|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||<0.0001
73942085|NCT02954354|147416131|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||<0.0001
73868489|NCT03121365|147281954|EQUIVALENCE|0.05||||||0.7635|TWO_SIDED|95.0|||||t-test, 2 sided|||Bayley Scales of Infant and Toddler Development Cognitive Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.7635
73868490|NCT03121365|147281954|EQUIVALENCE|0.05||||||0.0996|||||||t-test, 2 sided|||Language Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.0996
73942086|NCT02954354|147416131|SUPERIORITY|||||||0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.0010
73942087|NCT02954354|147416131|SUPERIORITY|||||||0.0002||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.0002
73942088|NCT02954354|147416132|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
73942089|NCT02954354|147416132|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
73942090|NCT02954354|147416132|SUPERIORITY|||||||0.4148||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.4148
73942091|NCT02954354|147416132|SUPERIORITY|||||||0.0338||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0338
73974807|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-14.57||||0.062|TWO_SIDED|95.0|-29.9|0.76||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Dyspnoea: Difference in LS mean||0.76|-29.90|0.0620
73974808|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|0.32||||0.9686|TWO_SIDED|95.0|-15.67|16.3||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Insomnia: Difference in LS mean||16.30|-15.67|0.9686
74039436|NCT02528253|147632440|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0281|TWO_SIDED|95.0|-0.76|-0.04|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.||-0.04|-0.76|0.0281
73868491|NCT03121365|147281954|EQUIVALENCE|0.05||||||0.2291|||||||t-test, 2 sided|||Gross Motor Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.2291
73868492|NCT03121365|147281955|EQUIVALENCE|0.05||||||0.018|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 9 months of age in the board book arm and e-book arm||||.0180
73868493|NCT03121365|147281955|EQUIVALENCE|0.05||||||0.4144|||||||t-test, 2 sided|||StimQ scores between infants 9 months of age and 12 months of age in the board book arm and e-book arm||||.4144
73868494|NCT03121365|147281955|EQUIVALENCE|0.05||||||0.4251|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 12 months of age in the board book arm and e-book arm||||.4251
73942092|NCT02954354|147416132|SUPERIORITY|||||||0.9619||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.9619
73942093|NCT02954354|147416132|SUPERIORITY|||||||0.8491||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.8491
73942094|NCT02954354|147416133|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
73942095|NCT02954354|147416134|SUPERIORITY|||||||0.0313||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.0313
73868495|NCT03121365|147281956|SUPERIORITY|||||||0.235||||||Difference in Board Book Reading|Chi-squared|||||||0.235
73868496|NCT03121365|147281957|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73868497|NCT03121365|147281958|SUPERIORITY|||||||0.601|||||||Chi-squared|||||||0.601
73868498|NCT03121365|147281959|SUPERIORITY|||||||0.219|||||||Chi-squared|||||||0.219
73868499|NCT03121365|147281960|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73942096|NCT02954354|147416135|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
73942097|NCT02954354|147416136|SUPERIORITY|||||||0.2424||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.2424
73868500|NCT03121365|147281961|SUPERIORITY|||||||0.574|||||||Chi-squared|||||||0.574
73868501|NCT03121365|147281962|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.430
73868502|NCT03121365|147281963|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73868503|NCT03121365|147281964|SUPERIORITY|||||||0.861|||||||Chi-squared|||||||0.861
73868504|NCT01959139|147281975|SUPERIORITY||Hazard Ratio (HR)|2.07|||<|0.01|TWO_SIDED|95.0|1.28|3.34|||Regression, Cox|||||3.34|1.28|<0.01
73868505|NCT01959139|147281976|SUPERIORITY||Hazard Ratio (HR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.66|||Regression, Cox|||||2.66|1.14|0.01
73868506|NCT04756804|147281982|OTHER|This was a descriptive study, no hypothesis testing was performed.|||||||||||||||||This was a descriptive study, no hypothesis testing was performed.|||
73868507|NCT00930553|147282008|SUPERIORITY_OR_OTHER||Percentage with SAD|22.33|||||TWO_SIDED|95.0|18.33|27.06|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||27.06|18.33|
73868508|NCT00930553|147282008|SUPERIORITY_OR_OTHER||Percentage with SAD|29.69|||||TWO_SIDED|95.0|25.42|34.49|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||34.49|25.42|
73868509|NCT00930553|147282009|SUPERIORITY_OR_OTHER||Percentage with SAD|9.35|||||TWO_SIDED|95.0|5.54|15.56|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||15.56|5.54|
73868510|NCT00930553|147282009|SUPERIORITY_OR_OTHER||Percentage with SAD|7.95|||||TWO_SIDED|95.0|4.48|13.9|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||13.90|4.48|
73868511|NCT00930553|147282009|SUPERIORITY_OR_OTHER||Percentage with SAD|20.42|||||TWO_SIDED|95.0|14.67|28.03|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||28.03|14.67|
73868512|NCT00930553|147282009|SUPERIORITY_OR_OTHER||Percentage with SAD|11.99|||||TWO_SIDED|95.0|7.63|18.58|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||18.58|7.63|
73868513|NCT00930553|147282010|SUPERIORITY_OR_OTHER||Percentage with SRD|32.69|||||TWO_SIDED|95.0|26.96|39.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||39.28|26.96|
73868514|NCT00930553|147282010|SUPERIORITY_OR_OTHER||Percentage with SRD|42.46|||||TWO_SIDED|95.0|37.08|48.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||48.28|37.08|
73868515|NCT00930553|147282011|SUPERIORITY_OR_OTHER||Percentage with SRD|16.92|||||TWO_SIDED|95.0|9.75|28.47|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||28.47|9.75|
73868516|NCT00930553|147282011|SUPERIORITY_OR_OTHER||Percentage with SRD|13.89|||||TWO_SIDED|95.0|8.47|22.33|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||22.33|8.47|
73868517|NCT02967510|147282033|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.304|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.304
73868518|NCT02967510|147282033|SUPERIORITY||Mean Difference (Final Values)|0.0|||=|0.109|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.109
73868519|NCT02967510|147282033|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.119|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.119
73868520|NCT02967510|147282034|SUPERIORITY||LS Mean Difference|-0.74|||<|0.001|TWO_SIDED|95.0|-1.031|-0.444|||ANCOVA|||||-0.444|-1.031|<0.001
73868521|NCT02967510|147282034|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.051|-0.458|||ANCOVA|||||-0.458|-1.051|<0.001
73942098|NCT02954354|147416137|SUPERIORITY||Difference|-72.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-48.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-48.0|-72.0|<0.0001
73868522|NCT02967510|147282034|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.951|-0.369|||ANCOVA|||||-0.369|-0.951|<0.001
73868523|NCT02967510|147282035|SUPERIORITY||LS Mean Difference|0.21|||<|0.001|TWO_SIDED|95.0|0.147|0.278|||ANCOVA|||||0.278|0.147|<0.001
73868524|NCT02967510|147282035|SUPERIORITY||LS Mean Difference|0.15|||<|0.001|TWO_SIDED|95.0|0.078|0.213|||ANCOVA|||||0.213|0.078|<0.001
73868525|NCT02967510|147282035|SUPERIORITY||LS Mean Difference|0.16|||<|0.001|TWO_SIDED|95.0|0.097|0.226|||ANCOVA|||||0.226|0.097|<0.001
73868526|NCT02967510|147282036|SUPERIORITY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.603|-0.4|||ANCOVA|||||-0.4|-0.603|<0.001
73868527|NCT02967510|147282036|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.572|-0.365|||ANCOVA|||||-0.365|-0.572|<0.001
73868528|NCT02967510|147282036|SUPERIORITY||LS Mean Difference|-0.43|||<|0.001|TWO_SIDED|95.0|-0.531|-0.331|||ANCOVA|||||-0.331|-0.531|<0.001
73868529|NCT02967510|147282037|SUPERIORITY||Mean Difference (Final Values)|0.0|||=|0.47|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.47
73868530|NCT02967510|147282037|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.448|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|0|-1|=0.448
74089179|NCT01045993|147731444|NON_INFERIORITY_OR_EQUIVALENCE|The statistical alternative hypothesis tested is that the survival curves of time to first perceptible relief confirmed by meaningful relief are not identical between two treatment groups, or equivalently, the hazard ratio between two treatment groups is not equal to 1.||||||0.046|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.||||||0.046
73942099|NCT02954354|147416138|SUPERIORITY||Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-24.0|-72.0|<0.0001
74089180|NCT01045993|147731445|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using analysis of variance (ANOVA) model with treatment term only in the model.||||||<0.001
74089181|NCT01045993|147731446|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using ANOVA model with treatment term only in the model.||||||0.002
74089182|NCT01045993|147731448|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint||||0.012
74089183|NCT01045993|147731448|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint||||0.016
74089184|NCT01045993|147731448|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint||||<0.001
74089185|NCT01045993|147731448|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint||||0.002
74089186|NCT01045993|147731448|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint||||<0.001
73942100|NCT02954354|147416139|SUPERIORITY||Difference|-24.0||||0.002|TWO_SIDED|95.0|-120.0|0.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||0.0|-120.0|0.0020
73942101|NCT02954354|147416140|SUPERIORITY||Difference|-24.0||||0.0102|TWO_SIDED|95.0|-48.0|24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||24.0|-48.0|0.0102
74089187|NCT01045993|147731448|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint||||<0.001
74089188|NCT01045993|147731448|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint||||0.003
74089189|NCT01045993|147731448|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint||||0.001
74089190|NCT01045993|147731449|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint||||0.012
74089191|NCT01045993|147731449|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint||||0.002
74089192|NCT01045993|147731449|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint||||0.033
74089193|NCT01045993|147731449|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint||||0.096
74089194|NCT01045993|147731449|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint||||0.002
74089195|NCT01045993|147731449|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint||||0.005
73868531|NCT02967510|147282037|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.451|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.451
73868532|NCT02967510|147282038|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.329|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.329
73868533|NCT02967510|147282038|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.348|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.348
73942102|NCT02954354|147416141|SUPERIORITY|||||||0.5973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.5973
73942103|NCT02954354|147416141|SUPERIORITY|||||||0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.0010
73942104|NCT02954354|147416141|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||<0.0001
73942105|NCT02954354|147416141|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||<0.0001
73942106|NCT02954354|147416141|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||<0.0001
73942107|NCT02954354|147416141|SUPERIORITY|||||||0.0115||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.0115
73942108|NCT02954354|147416141|SUPERIORITY|||||||0.1298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.1298
73942109|NCT02954354|147416141|SUPERIORITY|||||||0.117||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.1170
73942110|NCT02954354|147416141|SUPERIORITY|||||||0.0757||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.0757
73942111|NCT02954354|147416141|SUPERIORITY|||||||0.9453||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.9453
73942112|NCT02954354|147416141|SUPERIORITY|||||||0.8657||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.8657
73942113|NCT02954354|147416142|SUPERIORITY|||||||0.0458||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.0458
73942114|NCT02954354|147416142|SUPERIORITY|||||||0.7565||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.7565
73974809|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-7.95||||0.3002|TWO_SIDED|95.0|-23.23|7.33||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Appetite loss: Difference in LS mean||7.33|-23.23|0.3002
73942115|NCT02954354|147416142|SUPERIORITY|||||||0.3297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||0.3297
73942116|NCT02954354|147416142|SUPERIORITY|||||||0.4442||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||0.4442
73868534|NCT02967510|147282038|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.266|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.266
73868535|NCT02967510|147282039|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.122|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.122
73974810|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|1.79||||0.8374|TWO_SIDED|95.0|-15.7|19.29||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Constipation: Difference in LS mean||19.29|-15.70|0.8374
73974811|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-1.38||||0.8775|TWO_SIDED|95.0|-19.28|16.52||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Diarrhoea: Difference in LS mean||16.52|-19.28|0.8775
73974812|NCT03500549|147495039|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-7.4||||0.3066|TWO_SIDED|95.0|-21.76|6.95||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Financial difficulties: Difference in LS mean||6.95|-21.76|0.3066
73974813|NCT03500549|147495040|OTHER|Wilcoxon rank-sum test P-value for the comparison between treatments is based on median using stratified non-parametric analysis. The 95% CI is constructed using Hodges-Lehmann Estimation of Location Shift.|Median Difference (Final Values)|3.0|||<|0.0001|TWO_SIDED|95.0|2.0|4.0|||Wilcoxon rank-sum test|||||4.0|2.0|<0.0001
73974814|NCT04066075|147495063|SUPERIORITY|||||||0.73||||||The p-value represents the difference between telerehabilitation and usual care.|Multilevel linear regression model|||Multilevel modeling in linear regression analyses accounted for within-patient correlations for the 3 assessments at baseline, 1-month and 4-months. Rasch analysis using the method of successive dichotomizations was applied to estimate person measures. Power calculation: a matched pairs t-test revealed 18 subjects per group would detect a within-subject mean improvement of 0.14-logits with 0.17-logits standard deviation for the differences, 0.80 power and 0.05 type 1 error probability.||||0.73
73974815|NCT00747565|147495098|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||ETDRS line scores used for statistical comparisons with mean Snellen values reported above.||||<0.0001
73974816|NCT03777657|147495099|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0056|TWO_SIDED|95.0|0.59|0.94||The superiority boundary at the primary overall survival analysis was predefined using the O'Brien-Fleming boundary approximated using the Hwang-Shih-DeCani spending function at 0.0092.|One-sided Log Rank Test|One-Sided Log-Rank Test stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis (yes vs no).|The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.|||0.94|0.59|0.0056
73974817|NCT03777657|147495100|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0011|TWO_SIDED|95.0|0.7|0.92||The one sided P value boundary for superiority of overall survival in all randomized participants at final analysis was 0.0226 based on 776 actual observed deaths.|One-Sided Log-Rank Test|One-Sided Log-Rank test stratified by region (Asia vs Europe/North America), PD-L1 expression (\<5% vs ≥5%), and presence of peritoneal metastasis.|The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.|||0.92|0.70|0.0011
73974818|NCT03777657|147495101|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.56|0.83|||||The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.|||0.83|0.56|
73974819|NCT03777657|147495102|OTHER||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.03|2.04|||||Odds ratio between arms weas calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis.|||2.04|1.03|
73974820|NCT03777657|147495103|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.67|0.9|||||The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.|||0.90|0.67|
73974821|NCT03777657|147495104|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|1.03|1.72|||||Odds ratio between arms were calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America), PD-L1 expression and presence of peritoneal metastasis.|||1.72|1.03|
73974822|NCT03777657|147495107|OTHER||Least Squares (LS) Mean Difference|1.8|||||TWO_SIDED|95.0|-0.33|3.94|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 4||3.94|-0.33|
73974823|NCT03777657|147495107|OTHER||LS Mean Difference|2.52|||||TWO_SIDED|95.0|0.29|4.74|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6||4.74|0.29|
73868536|NCT02967510|147282039|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.188|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.188
73868537|NCT02967510|147282039|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.222|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.222
73868538|NCT02967510|147282040|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.393|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.393
73868539|NCT02967510|147282040|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.221|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.221
73868540|NCT02967510|147282040|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.432|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.432
73868541|NCT02967510|147282041|SUPERIORITY||LS Mean Difference|0.24|||=|0.65|TWO_SIDED|95.0|-1.0|1.487|||ANCOVA|||||1.487|-1|=0.65
73868542|NCT02967510|147282041|SUPERIORITY||LS Mean Difference|-0.24|||=|0.361|TWO_SIDED|95.0|-1.568|1.09|||ANCOVA|||||1.09|-1.568|=0.361
73868543|NCT02967510|147282041|SUPERIORITY||LS Mean Difference|0.03|||=|0.522|TWO_SIDED|95.0|-1.188|1.257|||ANCOVA|||||1.257|-1.188|=0.522
73868544|NCT02967510|147282042|SUPERIORITY||LS Mean Difference|-0.56|||=|0.043|TWO_SIDED|95.0|-1.204|0.079|||ANCOVA|||||0.079|-1.204|=0.043
73868545|NCT02967510|147282042|SUPERIORITY||LS Mean Difference|-0.51|||=|0.061|TWO_SIDED|95.0|-1.158|0.137|||ANCOVA|||||0.137|-1.158|=0.061
73868546|NCT02967510|147282042|SUPERIORITY||LS Mean Difference|-0.48|||=|0.071|TWO_SIDED|95.0|-1.111|0.16|||ANCOVA|||||0.16|-1.111|=0.071
73868547|NCT02967510|147282043|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.012|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.012
73868548|NCT02967510|147282043|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.007|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.007
73868549|NCT02967510|147282043|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
73868550|NCT02967510|147282044|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.438|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.438
73868551|NCT02967510|147282044|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.388|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.388
73942117|NCT02954354|147416142|SUPERIORITY|||||||0.6029||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||0.6029
73942118|NCT02954354|147416142|SUPERIORITY|||||||0.9881||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.9881
73974824|NCT03777657|147495107|OTHER||LS Mean Difference|1.44|||||TWO_SIDED|95.0|-0.27|3.16||||||Analysis of Change from Baseline in Physical Functioning at Cycle 4||3.16|-0.27|
73942119|NCT02954354|147416142|SUPERIORITY|||||||0.9257||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.9257
73942120|NCT02954354|147416142|SUPERIORITY|||||||0.5317||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.5317
73868552|NCT02967510|147282044|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.259|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.259
73868553|NCT02967510|147282045|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.022|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.022
73868554|NCT02967510|147282045|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.02|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.02
73868555|NCT02967510|147282045|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.003|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.003
73942121|NCT02954354|147416142|SUPERIORITY|||||||0.2144||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.2144
73942122|NCT02954354|147416142|SUPERIORITY|||||||0.0413||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.0413
73942123|NCT02954354|147416142|SUPERIORITY|||||||0.0409||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.0409
73942124|NCT02954354|147416143|SUPERIORITY||Difference|-19.8|||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
73942125|NCT02954354|147416144|SUPERIORITY||Difference|-0.7||||0.4194||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.4194
73942126|NCT02954354|147416145|SUPERIORITY|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-23.1|||<|0.0001|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
73974825|NCT03777657|147495107|OTHER||LS Mean Difference|2.46|||||TWO_SIDED|95.0|0.49|4.43|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Physical Functioning at Cycle 6||4.43|0.49|
73974826|NCT03777657|147495108|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|95.0|-3.79|1.15|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Fatigue at Cycle 4||1.15|-3.79|
73974827|NCT03777657|147495108|OTHER||LS Mean Difference|-3.01|||||TWO_SIDED|95.0|-5.78|-0.24|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Fatigue at Cycle 6||-0.24|-5.78|
73974828|NCT03777657|147495109|OTHER||LS Mean Difference|-1.11|||||TWO_SIDED|95.0|-2.53|0.31|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 4||0.31|-2.53|
73942127|NCT02954354|147416146|SUPERIORITY||Difference|1.3||||0.4856||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.4856
73942128|NCT02954354|147416147|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7173|TWO_SIDED|95.0|-0.5|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours||0.7|-0.5|0.7173
73942129|NCT02954354|147416147|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.3||0.0009|TWO_SIDED|95.0|-1.7|-0.4||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours||-0.4|-1.7|0.0009
73942130|NCT02954354|147416147|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.4|-1.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours||-1.1|-2.4|<0.0001
73942131|NCT02954354|147416147|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.4|-1.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours||-1.2|-2.4|<0.0001
73942132|NCT02954354|147416147|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.0|-0.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours||-0.9|-2.0|<0.0001
73942133|NCT02954354|147416147|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|95.0|-1.5|-0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours||-0.5|-1.5|0.0001
73974829|NCT03777657|147495109|OTHER||LS Mean Difference|-1.62|||||TWO_SIDED|95.0|-3.12|-0.12|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 6||-0.12|-3.12|
73974830|NCT03777657|147495109|OTHER||LS Mean Difference|-1.51|||||TWO_SIDED|95.0|-3.13|0.11|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 4||0.11|-3.13|
73942134|NCT02954354|147416147|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1979|TWO_SIDED|95.0|-0.8|0.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours||0.2|-0.8|0.1979
73942135|NCT02954354|147416147|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1079|TWO_SIDED|95.0|-0.8|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours||0.1|-0.8|0.1079
73942136|NCT02954354|147416147|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5805|TWO_SIDED|95.0|-0.6|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours||0.3|-0.6|0.5805
73942137|NCT02954354|147416147|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.8057|TWO_SIDED|95.0|-0.4|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours||0.5|-0.4|0.8057
73942138|NCT02954354|147416147|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9525|TWO_SIDED|95.0|-0.6|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours||0.6|-0.6|0.9525
73974831|NCT03777657|147495109|OTHER||LS Mean Difference|-0.77|||||TWO_SIDED|95.0|-2.31|0.76|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 6||0.76|-2.31|
73974832|NCT03777657|147495109|OTHER||LS Mean Difference|-2.23|||||TWO_SIDED|95.0|-4.26|-0.2|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 4||-0.20|-4.26|
73974833|NCT03777657|147495109|OTHER||LS Mean Difference|-1.88|||||TWO_SIDED|95.0|-4.03|0.27|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 6||0.27|-4.03|
73974834|NCT03777657|147495109|OTHER||LS Mean Difference|-0.93|||||TWO_SIDED|95.0|-2.85|0.99|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 4||0.99|-2.85|
74039437|NCT02528253|147632441|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|-2.21|-0.43|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.43|-2.21|0.0035
73942139|NCT02954354|147416148|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4091|TWO_SIDED|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours||0.8|-0.3|0.4091
73942140|NCT02954354|147416148|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3073|TWO_SIDED|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours||0.8|-0.3|0.3073
73868556|NCT02967510|147282046|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.002|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.002
73942141|NCT02954354|147416148|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3465|TWO_SIDED|95.0|-0.8|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours||0.3|-0.8|0.3465
73942142|NCT02954354|147416148|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4285|TWO_SIDED|95.0|-0.3|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours||0.7|-0.3|0.4285
73942143|NCT02954354|147416148|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6703|TWO_SIDED|95.0|-0.4|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours||0.6|-0.4|0.6703
73942144|NCT02954354|147416148|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7187|TWO_SIDED|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours||0.5|-0.3|0.7187
73942145|NCT02954354|147416148|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.135|TWO_SIDED|95.0|-0.1|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours||0.7|-0.1|0.1350
73974835|NCT03777657|147495109|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|95.0|-3.42|0.77|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 6||0.77|-3.42|
73974836|NCT03777657|147495109|OTHER||LS Mean Difference|-1.59|||||TWO_SIDED|95.0|-3.28|0.09|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 4||0.09|-3.28|
73974837|NCT03777657|147495109|OTHER||LS Mean Difference|-1.74|||||TWO_SIDED|95.0|-3.55|0.06|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 6||0.06|-3.55|
73974838|NCT05120856|147495125|SUPERIORITY||Slope|-1.106369|STANDARD_ERROR_OF_MEAN|0.4985347||0.026|TWO_SIDED|95.0|-2.083479|-0.129259||This is the p value for the overall group x time interaction.|Mixed Models Analysis|The model compared groups' change across all time points Time was coded as a continuous variable (i.e., 0, 4, 8, and 16).|This is the effect estimate for the group x time interaction.|||-0.129259|-2.083479|.026
73942146|NCT02954354|147416148|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7046|TWO_SIDED|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours||0.5|-0.3|0.7046
73974839|NCT05120856|147495125|SUPERIORITY||Mean Difference (Final Values)|5.025|STANDARD_ERROR_OF_MEAN|8.737||0.565|TWO_SIDED|95.0|-12.098|22.149|||t-test, 2 sided|||planned between-group post-hoc comparison at 4-week follow-up||22.149|-12.098|.565
73974840|NCT05120856|147495125|SUPERIORITY||Mean Difference (Final Values)|-3.349|STANDARD_ERROR_OF_MEAN|8.891||0.706|TWO_SIDED|95.0|-20.774|14.077|||t-test, 2 sided|||Planned post-hoc comparison between groups at 8-week follow-up||14.077|-20.774|.706
73974841|NCT05120856|147495125|SUPERIORITY||Mean Difference (Final Values)|-6.921|STANDARD_ERROR_OF_MEAN|9.394||0.461|TWO_SIDED|95.0|-25.332|11.491|||t-test, 2 sided|||Planned post-hoc comparison between groups at 16-week follow-up||11.491|-25.332|.461
73974842|NCT05120856|147495125|SUPERIORITY||Slope|-1.0838|STANDARD_ERROR_OF_MEAN|0.4798||0.0252|TWO_SIDED|95.0|-2.0229626|-0.1419329||This is the p value for the group x time interaction|Mixed Models Analysis|||In an additional sensitivity analysis, past-week alcohol use data was excluded if a participant reported having been in residential/inpatient treatment where they could not access alcohol for the whole of the past week at the time of follow-up. This resulted in data for one participant in the ApBM group being excluded at week 8, and 1 control being excluded at week 16.||-0.1419329|-2.0229626|.0252
73974843|NCT05120856|147495126|SUPERIORITY||Slope|-0.016|STANDARD_ERROR_OF_MEAN|0.033||0.633|TWO_SIDED|95.0|-0.08|0.05||This is the p value for the time x group interaction.|Mixed Models Analysis|||This is the test for the overall CEQ-F scores||0.05|-0.08|.633
73974844|NCT05120856|147495126|SUPERIORITY||Slope|-0.033|STANDARD_ERROR_OF_MEAN|0.041||0.411|TWO_SIDED|95.0|-0.11|0.05||This is for the time x group interaction for the intensity subscale|Mixed Models Analysis|||This is for the test of the CEQ-F Intensity subscale score||0.05|-0.11|.411
74039438|NCT02528253|147632441|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46||0.0002|TWO_SIDED|95.0|-2.64|-0.83|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.83|-2.64|0.0002
73868557|NCT02967510|147282046|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.331|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.331
73868558|NCT02967510|147282046|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.043|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.043
73868559|NCT02967510|147282047|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.022|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.022
73942147|NCT02954354|147416148|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2765|TWO_SIDED|95.0|-0.2|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours||0.6|-0.2|0.2765
73942148|NCT02954354|147416148|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0274|TWO_SIDED|95.0|0.0|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours||0.8|0.0|0.0274
73942149|NCT02954354|147416148|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6001|TWO_SIDED|95.0|-0.3|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours||0.6|-0.3|0.6001
73942150|NCT02954354|147416149|SUPERIORITY||Difference|-17.5|||<|0.0001|TWO_SIDED|95.0|-21.1|-11.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-11.9|-21.1|<0.0001
73974845|NCT05120856|147495126|SUPERIORITY||Slope|-0.009|STANDARD_ERROR_OF_MEAN|0.036||0.808|TWO_SIDED|95.0|-0.08|0.06||p value for the time x group interaction for Imagery subscale|Mixed Models Analysis|||Analysis of CEQ-F Imagery subscale score||0.06|-0.08|.808
74031322|NCT00418262|147616140|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.28|0.26|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.26|-0.28|
74039439|NCT02528253|147632442|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.3118|TWO_SIDED|95.0|-0.5|0.16|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.16|-0.50|0.3118
73942151|NCT02954354|147416150|SUPERIORITY|||||||0.9225||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.9225
73942152|NCT02954354|147416151|SUPERIORITY|||||||0.7866||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.7866
73974846|NCT05120856|147495126|SUPERIORITY||Slope|-0.006|STANDARD_ERROR_OF_MEAN|0.041||0.886|TWO_SIDED|95.0|-0.09|0.08||This is the p value for the time x group interaction for the Intrusiveness subscale score|Mixed Models Analysis|||This is for the analysis of the CEQ-F Intrusiveness subscale score||0.08|-0.09|.886
73868560|NCT02967510|147282047|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.032|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.032
73942153|NCT02954354|147416151|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||<0.0001
73974847|NCT05120856|147495127|SUPERIORITY||Slope|0.083|STANDARD_ERROR_OF_MEAN|0.066||0.207|TWO_SIDED|95.0|-0.046|0.212||This is the p value for the time x group interaction|Mixed Models Analysis|||||0.212|-0.046|.207
73974848|NCT05120856|147495128|SUPERIORITY||Slope|-0.026|STANDARD_ERROR_OF_MEAN|0.166||0.876|TWO_SIDED|95.0|-0.352|0.3||This is the p value for the group x time interaction.|Mixed Models Analysis|||||0.300|-0.352|.876
73974849|NCT05120856|147495129|SUPERIORITY||Slope|-0.069|STANDARD_ERROR_OF_MEAN|0.037||0.064|TWO_SIDED|95.0|-0.142|0.004||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.004|-0.142|.064
73974850|NCT05120856|147495130|SUPERIORITY||Slope|-0.059|STANDARD_ERROR_OF_MEAN|0.143||0.679|TWO_SIDED|95.0|-0.338|0.22||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.220|-0.338|.679
73868561|NCT02967510|147282047|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.001
73868562|NCT02967510|147282048|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.176|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.176
73868563|NCT02967510|147282048|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.358|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.358
73868564|NCT02967510|147282048|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.21|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.21
73868565|NCT02967510|147282049|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.106|TWO_SIDED|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||1|0|=0.106
73868566|NCT02967510|147282049|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.229|TWO_SIDED|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||1|0|=0.229
73868567|NCT02967510|147282049|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.345|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.345
73868568|NCT02967510|147282050|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.026|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.026
73868569|NCT02967510|147282050|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.424|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.424
73868570|NCT02967510|147282050|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.414|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.414
73868571|NCT02967510|147282051|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.36|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.36
73942154|NCT02954354|147416151|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||<0.0001
73942155|NCT02954354|147416151|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||<0.0001
73974851|NCT05120856|147495132|SUPERIORITY||Slope|0.072|STANDARD_ERROR_OF_MEAN|0.086||0.403|TWO_SIDED|95.0|-0.097|0.24||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.240|-0.097|.403
73942156|NCT02954354|147416151|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||<0.0001
73974852|NCT05120856|147495133|SUPERIORITY||Slope|-0.052|STANDARD_ERROR_OF_MEAN|0.037||0.161|TWO_SIDED|95.0|-0.126|0.021||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of psychological well-being ratings.||0.021|-0.126|.161
73868572|NCT02967510|147282051|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.12|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.12
73868573|NCT02967510|147282051|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.266|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.266
73868574|NCT02967510|147282052|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.47|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.47
73868575|NCT02967510|147282052|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.137|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.137
73868576|NCT02967510|147282052|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.133|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.133
73868577|NCT02967510|147282053|SUPERIORITY||LS Mean Difference|0.74|||=|0.85|TWO_SIDED|95.0|-0.669|2.153|||ANCOVA|||||2.153|-0.669|=0.85
73868578|NCT02967510|147282053|SUPERIORITY||LS Mean Difference|0.87|||=|0.877|TWO_SIDED|95.0|-0.611|2.361|||ANCOVA|||||2.361|-0.611|=0.877
73868579|NCT02967510|147282053|SUPERIORITY||LS Mean Difference|-0.64|||=|0.178|TWO_SIDED|95.0|-2.009|0.728|||ANCOVA|||||0.728|-2.009|=0.178
73868580|NCT02967510|147282054|SUPERIORITY||LS Mean Difference|-0.16|||=|0.323|TWO_SIDED|95.0|-0.854|0.531|||ANCOVA|||||0.531|-0.854|=0.323
73868581|NCT02967510|147282054|SUPERIORITY||LS Mean Difference|-0.22|||=|0.272|TWO_SIDED|95.0|-0.917|0.484|||ANCOVA|||||0.484|-0.917|=0.272
73868582|NCT02967510|147282054|SUPERIORITY||LS Mean Difference|-0.6|||=|0.043|TWO_SIDED|95.0|-1.29|0.084|||ANCOVA|||||0.084|-1.29|=0.043
73868583|NCT02967510|147282055|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.009|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.009
73868584|NCT02967510|147282055|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.025|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.025
73868585|NCT02967510|147282055|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
73868586|NCT02967510|147282056|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.04|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.04
73868587|NCT02967510|147282056|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.259|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.259
73868588|NCT02967510|147282056|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.104|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.104
73868589|NCT02967510|147282057|SUPERIORITY||Median Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
73942157|NCT02954354|147416151|SUPERIORITY|||||||0.7044||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.7044
73942158|NCT02954354|147416151|SUPERIORITY|||||||0.8512||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.8512
73868590|NCT02967510|147282057|SUPERIORITY||Median Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
73942159|NCT02954354|147416151|SUPERIORITY|||||||0.8783||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.8783
73942160|NCT02954354|147416151|SUPERIORITY|||||||0.8291||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.8291
73942161|NCT02954354|147416151|SUPERIORITY|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.8644
73942162|NCT02954354|147416151|SUPERIORITY|||||||0.9312||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.9312
73942163|NCT02954354|147416152|SUPERIORITY|||||||0.2953||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.2953
73942164|NCT02954354|147416152|SUPERIORITY|||||||0.5414||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.5414
73942165|NCT02954354|147416152|SUPERIORITY|||||||0.2079||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||0.2079
73974853|NCT05120856|147495133|SUPERIORITY||Slope|-0.029|STANDARD_ERROR_OF_MEAN|0.036||0.425|TWO_SIDED|95.0|-0.099|0.042||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of physical well-being ratings||0.042|-0.099|.425
73974854|NCT05120856|147495133|SUPERIORITY||Slope|-0.039|STANDARD_ERROR_OF_MEAN|0.034||0.247|TWO_SIDED|95.0|-0.106|0.027||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of quality of life ratings||0.027|-0.106|.247
73942166|NCT02954354|147416152|SUPERIORITY|||||||0.7771||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||48 hours||||0.7771
73942167|NCT02954354|147416152|SUPERIORITY|||||||0.0215||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||0.0215
73942168|NCT02954354|147416152|SUPERIORITY|||||||0.8033||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||96 hours||||0.8033
73942169|NCT02954354|147416152|SUPERIORITY|||||||0.4157||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.4157
73974855|NCT05120856|147495134|SUPERIORITY||Slope|3.645|STANDARD_ERROR_OF_MEAN|10.369||0.725|TWO_SIDED|95.0|-16.68|23.97||This is the p value for the group x time interaction|Mixed Models Analysis|||||23.97|-16.68|.725
73942170|NCT02954354|147416152|SUPERIORITY|||||||0.5908||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||144 hours||||0.5908
73974856|NCT00227266|147495144|SUPERIORITY_OR_OTHER_LEGACY||Spearman's correlation|0.93|||<|0.001|||||||Spearman's correlation|||MHFMS-Extend was not normally distributed at p=0.048. Test-retest reliability of MHFMS-Extend measurements from the first (S1) to the second (S2) screening visit was analyzed using Spearman's correlation.||||<0.001
73974857|NCT02678689|147495149|SUPERIORITY|The two-sample T-test with unequal variance was conducted at a significance level of 0.05|||||<|0.0001|||||||t-test, unequal variance|||||||< 0.0001
73974858|NCT02678689|147495150|SUPERIORITY||Hazard Ratio (HR)|0.091|||<|0.0001|TWO_SIDED|95.0|0.021|0.393|||Cox Model Wald Test||Hazard ratio is based on Cox proportional hazards model with a factor of study group|||0.393|0.021|<.0001
73942171|NCT02954354|147416152|SUPERIORITY|||||||0.2975||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.2975
73942172|NCT02954354|147416152|SUPERIORITY|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.8644
73974859|NCT02678689|147495151|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.0032|TWO_SIDED|95.0|0.0|0.0|||Cox Model Wald Test||Hazard ratio is based on Cox proportional hazards model with a factor of study group|||0.000|0.000|0.0032
73974860|NCT02678689|147495152|SUPERIORITY||||||<|0.0001|||||||t-test, unequal variance|||||||<.0001
73974861|NCT02678689|147495153|SUPERIORITY||||||<|0.0001|||||||t-test, unequal variance|||||||<.0001
73868591|NCT02967510|147282057|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
73942173|NCT02954354|147416152|SUPERIORITY|||||||0.5573||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.m|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.5573
73942174|NCT02954354|147416153|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.2557|TWO_SIDED|95.0|-0.24|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours||0.06|-0.24|0.2557
73942175|NCT02954354|147416153|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.46|-0.22||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours||-0.22|-0.46|<0.0001
73942176|NCT02954354|147416153|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.52|-0.29||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours||-0.29|-0.52|<0.0001
73942177|NCT02954354|147416153|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.48|-0.27||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours||-0.27|-0.48|<0.0001
73974862|NCT02678689|147495154|SUPERIORITY||Hazard Ratio (HR)|0.209||||0.0081|TWO_SIDED|95.0|0.059|0.735|||Cox Model Wald Test|The p value is a test that the hazard ratio equal to 1.|"Hazard ratio is based on Cox proportional hazards model with a factor of study group.~Hazard Ratio (HR) 190-203 vs DEM-CHILD."|||0.735|0.059|0.0081
73942178|NCT02954354|147416153|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.31|-0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours||-0.13|-0.31|<0.0001
73942179|NCT02954354|147416153|SUPERIORITY||LS Mean Dfference|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.4484|TWO_SIDED|95.0|-0.13|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours||0.06|-0.13|0.4484
73942180|NCT02954354|147416153|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.5963|TWO_SIDED|95.0|-0.07|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||0.11|-0.07|0.5963
73974863|NCT05048394|147495176|EQUIVALENCE|Equivalence is defined as a difference of 0.|||||<|0.001||||||Threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73974864|NCT05048394|147495177|EQUIVALENCE|Equivalence is defined as a difference of 0.||||||0.14||||||Threshold for significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||0.14
73974865|NCT01617369|147495199|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Paired t-test performed. Null hypothesis is that no difference in clearance 30 min and 4 hr after HS inhalation exists||||<.05
73974866|NCT00246805|147495252|SUPERIORITY_OR_OTHER||Proportions|48.0|||<|0.0001|TWO_SIDED|95.0|36.0|61.0|||Z-test for proportions|||VRS ON vs. VRS OFF||61|36|<0.0001
73974867|NCT03455985|147495318|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.4||0.09|TWO_SIDED||||||Regression, Linear|||||||0.09
73974868|NCT03455985|147495319|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
73974869|NCT03455985|147495320|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
73974870|NCT03455985|147495321|SUPERIORITY||Mean Difference (Final Values)|-26.5|STANDARD_ERROR_OF_MEAN|30.3||0.39|TWO_SIDED||||||Regression, Linear|||||||0.39
73974871|NCT02502526|147495330|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
73974872|NCT02502526|147495331|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
73974873|NCT02502526|147495331|SUPERIORITY|||||||0.605|||||||ANCOVA|||||||0.605
73974874|NCT02502526|147495332|SUPERIORITY|||||||0.52|||||||ANCOVA|||||||0.520
73974875|NCT02502526|147495332|SUPERIORITY|||||||0.817|||||||ANCOVA|||||||0.817
73974876|NCT03170648|147495361|OTHER|||||||0.02||||||T2 (post) vs.T1(pre)|t-test, 2 sided|||||||0.02
73974877|NCT03509909|147495363|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
74009004|NCT01641237|147568703|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.25||||0.0112|TWO_SIDED|95.0|0.98|7.53||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||7.53|0.98|0.0112
73868592|NCT02967510|147282058|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
73868593|NCT02967510|147282058|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.054|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.054
74009005|NCT01641237|147568704|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %RER as a function of fluoride concentration.||||<0.0001
73868594|NCT02967510|147282058|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|<0.001
74009006|NCT01641237|147568704|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANOVA|||Test for quadratic dose-response relationship was performed for %RER as a function of fluoride concentration.||||0.0002
73942181|NCT02954354|147416154|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.07||0.0937|TWO_SIDED|95.0|-0.02|0.24||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours||0.24|-0.02|0.0937
73942182|NCT02954354|147416154|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3343|TWO_SIDED|95.0|-0.05|0.16||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours||0.16|-0.05|0.3343
73942183|NCT02954354|147416154|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9258|TWO_SIDED|95.0|-0.09|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours||0.10|-0.09|0.9258
73942184|NCT02954354|147416154|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6574|TWO_SIDED|95.0|-0.1|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours||0.06|-0.10|0.6574
73942185|NCT02954354|147416154|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.852|TWO_SIDED|95.0|-0.09|0.07||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours||0.07|-0.09|0.8520
73942186|NCT02954354|147416154|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.4532|TWO_SIDED|95.0|-0.05|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours||0.11|-0.05|0.4532
73942187|NCT02954354|147416154|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.157|TWO_SIDED|95.0|-0.02|0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||120 hours||0.13|-0.02|0.1570
74009007|NCT01641237|147568704|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|32.38|||<|0.0001|TWO_SIDED|95.0|25.18|39.59||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||39.59|25.18|<0.0001
73868595|NCT02967510|147282059|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.008|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.008
73868596|NCT02967510|147282059|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.01|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.01
73942188|NCT02954354|147416155|SUPERIORITY||Difference|-23.1||||0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough||||0.0001
73942189|NCT02954354|147416155|SUPERIORITY||Difference|-9.0||||0.0298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat||||0.0298
73942190|NCT02954354|147416155|SUPERIORITY||Difference|-11.8||||0.0297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache||||0.0297
73942191|NCT02954354|147416155|SUPERIORITY||Difference|-20.7||||0.0027||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal Congestion||||0.0027
73942192|NCT02954354|147416155|SUPERIORITY||Difference|-4.9||||0.0003||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||Feverishness or chills||||0.0003
73942193|NCT02954354|147416155|SUPERIORITY||Difference|-8.1||||0.0094||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain||||0.0094
73942194|NCT02954354|147416155|SUPERIORITY||Difference|-15.3||||0.0007||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue||||0.0007
73942195|NCT02954354|147416156|SUPERIORITY||Difference|6.8||||0.6623||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough||||0.6623
73942196|NCT02954354|147416156|SUPERIORITY||Difference|1.8||||0.8184||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat||||0.8184
73942197|NCT02954354|147416156|SUPERIORITY||Difference|1.3||||0.9989||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache||||0.9989
73942198|NCT02954354|147416156|SUPERIORITY||Difference|1.7||||0.3706||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal congestion||||0.3706
73942199|NCT02954354|147416156|SUPERIORITY||Difference|-0.1||||0.9973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Feverishness or chills||||0.9973
73868597|NCT02967510|147282059|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.001
73868598|NCT02967510|147282060|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.071|-0.548|||ANCOVA|||||-0.548|-1.071|<0.001
73868599|NCT02967510|147282060|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.013|-0.484|||ANCOVA|||||-0.484|-1.013|<0.001
73942200|NCT02954354|147416156|SUPERIORITY||Difference|-0.7||||0.676||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain||||0.6760
73942201|NCT02954354|147416156|SUPERIORITY||Difference|2.2||||0.4241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue||||0.4241
73942202|NCT02954354|147416157|SUPERIORITY|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-39.5||||0.0563|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.0563
73868600|NCT02967510|147282060|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.916|-0.397|||ANCOVA|||||-0.397|-0.916|<0.001
73942203|NCT02954354|147416158|SUPERIORITY||Difference|-0.6||||0.7176||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.7176
73942204|NCT02954354|147416159|SUPERIORITY|||||||0.6728||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.6728
73942205|NCT02954354|147416160|SUPERIORITY|||||||0.2217||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.2217
73868601|NCT02967510|147282061|SUPERIORITY||LS Mean Difference|0.44|||<|0.001|TWO_SIDED|95.0|0.337|0.535|||ANCOVA|||||0.535|0.337|<0.001
73868602|NCT02967510|147282061|SUPERIORITY||LS Mean Difference|0.39|||<|0.001|TWO_SIDED|95.0|0.291|0.494|||ANCOVA|||||0.494|0.291|<0.001
73868603|NCT02967510|147282061|SUPERIORITY||LS Mean Difference|0.34|||<|0.001|TWO_SIDED|95.0|0.245|0.439|||ANCOVA|||||0.439|0.245|<0.001
73868604|NCT02967510|147282062|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.575|-0.371|||ANCOVA|||||-0.371|-0.575|<0.001
74009008|NCT01641237|147568704|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|31.46|||<|0.0001|TWO_SIDED|95.0|24.25|38.67||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||38.67|24.25|<0.0001
74009009|NCT01641237|147568704|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|20.81|||<|0.0001|TWO_SIDED|95.0|13.6|28.02||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||28.02|13.60|<0.0001
73942206|NCT01499082|147416247|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.056|||TWO_SIDED|95.0|-0.112|0.107||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.||0.107|-0.112|
73942207|NCT01499082|147416248|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.79||||0.0045|TWO_SIDED|95.0|0.67|0.93|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (\<8.0 and \>=8.0%).||0.93|0.67|0.0045
73942208|NCT01499082|147416249|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.162||0.6909|TWO_SIDED|95.0|-0.383|0.254|||ANCOVA|||Change in pre-injection SMPG was analyzed using an ANCOVA model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycemia was significant.||0.254|-0.383|0.6909
73942209|NCT01499082|147416258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|-0.189|0.298||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline HbA1c value as a covariate.||0.298|-0.189|
73942210|NCT04557930|147416270|SUPERIORITY||Odds Ratio (OR)|0.96||||0.41|TWO_SIDED|95.0|0.88|1.06|||Mixed Models Analysis|||We tested the association between exposure to the intervention and the incidence of ACP billing in the pre- and post-intervention periods using a mixed effects logistic regression model, adjusting for time, patient and hospital covariates.||1.06|0.88|0.41
73942211|NCT04557930|147416270|SUPERIORITY|Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Odds Ratio (OR)|1.03||||0.74|TWO_SIDED|95.0|0.89|1.19|||Mixed Models Analysis|Overall effect allowing effect heterogeneity across steps \<0.001 Interaction effect \<0.001|Step 1 cohort|||1.19|0.89|0.74
73974878|NCT00979121|147495369|SUPERIORITY_OR_OTHER||difference in % of pts alive at 60 days|4.0||||0.21|TWO_SIDED|95.0|-2.3|10.2||The monitoring boundaries were designed to have a low probability of stopping for futility before 750 patients. The maximum sample size was 1000 patients. Efficacy stopping was based on mortality; futility stopping was based on mortality and VFDs.|Proc lifetest|Proc lifetest was used to calculate mortality mean and variance due to one subject lost to follow up who was censored.||Hospital mortality to day 60 was estimated using the Kaplan Meier estimate, with patients discharged home before day 60 considered alive at day 60. The analysis was stratified by co-enrolled treatment assignments for 81 patients also enrolled in a randomized clinical trial of two different nutritional strategies. A maximum of 1000 patients were to be enrolled, providing a 92% probability of rejecting the null hypothesis for the effect on mortality if a true difference in mortality was 9%.||10.2|-2.3|0.21
73974879|NCT00979121|147495370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.96||95.0|-1.6|1.5|||ANCOVA|||Ventilator, ICU free, and organ failure free days were analyzed by analysis of variance, utilizing treatment assignment where applicable.||1.5|-1.6|0.96
73974880|NCT00859781|147495420|SUPERIORITY||proportion difference|0.26||||0.08|TWO_SIDED|95.0|0.008|0.52|||Fisher Exact||Direction = 177Lu-J591 + Ketoconazole proportion free of radiographically evident metastases minus 111ln-J591 + Ketoconazole proportion free of radiographically evident metastases.|||0.52|0.008|0.08
73942212|NCT04557930|147416270|SUPERIORITY||Odds Ratio (OR)|1.15||||0.09|TWO_SIDED|95.0|0.98|1.36|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 2 cohort|1.36|0.98|0.09
73942213|NCT04557930|147416270|SUPERIORITY||Odds Ratio (OR)|1.13||||0.11|TWO_SIDED|95.0|0.97|1.33|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 3 cohort|1.33|0.97|0.11
73974881|NCT02415127|147495444|SUPERIORITY|||||||0.5442||||||From a repeated-measures ANCOVA with fixed effects of treatment, visit, and treatment\*visit with baseline score and investigative site as covariates using an unstructured covariance matrix, testing ACTIMMUNE® vs placebo.|ANCOVA|||The primary and secondary efficacy endpoints were tested in a hierarchical manner. Each endpoint was tested in sequential order and the current endpoint must have shown statistical significance (p \< 0.05) prior to performing testing the next endpoint. The primary endpoint, FARS-mNeuro, was to be tested first, followed by the key secondary endpoint, ADL, followed by the other secondary endpoints, T25FW, FARS-mNeuro responder rate, and FARStot.||||0.5442
73974882|NCT05630833|147495506|OTHER||Lower 10th percentile (%)|48.2|||||||||||||Lower 10th percentile of therapeutic successes was calculated from the predictive distribution.|As defined in Statistical Analysis Plan, consistency with the global studies is demonstrated if the success criterion for gepotidacin is set to require a therapeutic response rate greater than lower 10th percentile value of the predictive distribution.||||
73974883|NCT03905694|147495541|OTHER|Not applied|Least Squares (LS) Mean|-71.97|||||TWO_SIDED|95.0|-77.52|-66.42|||Mixed model for repeated measures (MMRM)|||Mixed-effect Model Repeated Measures (MMRM) includes scheduled visits (months 3, 4, 5, and 6) and baseline spot urinary oxalate:creatine ratio as fixed effects. Autoregressive (1) was used to model the within-patient error.||-66.42|-77.52|
73974884|NCT02866942|147495627|OTHER|||||||0.26|||||||McNemar|||||||0.26
73974885|NCT03614663|147495631|SUPERIORITY|||||||0.321|||||||MMRM - Mixed model for repeated measures|||||||0.321
73974886|NCT03614663|147495632|SUPERIORITY|||||||0.149|||||||MMRM - Mixed model for repeated measures|||||||0.149
73974887|NCT03614663|147495633|SUPERIORITY|||||||0.607|||||||MMRM - Mixed model for repeated measures|||||||0.607
73974888|NCT03614663|147495634|SUPERIORITY|||||||0.426|||||||ANOVA|||||||0.426
73868605|NCT02967510|147282062|SUPERIORITY||LS Mean Difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.592|-0.383|||ANCOVA|||||-0.383|-0.592|<0.001
73868606|NCT02967510|147282062|SUPERIORITY||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3|||ANCOVA|||||-0.3|-0.5|<0.001
73942214|NCT04557930|147416270|SUPERIORITY||Odds Ratio (OR)|0.66|||<|0.001|TWO_SIDED|95.0|0.57|0.76|||Mixed Models Analysis||Step 4 cohort|Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.||0.76|0.57|<0.001
73942215|NCT04557930|147416270|SUPERIORITY||Odds Ratio (OR)|0.95||||0.49|TWO_SIDED|95.0|0.89|1.19|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 5 cohort|1.19|0.89|0.49
73868607|NCT00856544|147282075|SUPERIORITY_OR_OTHER||Percent difference|27.04|||<|0.0001|TWO_SIDED|95.0|17.94|36.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||36.13|17.94|<0.0001
73942216|NCT05899686|147416306|EQUIVALENCE|Equivalence was defined as ANOVA p\<0.05||||||0.65|||||||ANOVA|||Maximum percent change from baseline (light transmittance) during 60 heart beats after the tetanic stimulus were compared between the three stimulus locations using ANOVA||||0.65
73942217|NCT02170025|147416307|OTHER||Bayesian analysis|-1.3|||||TWO_SIDED|90.0|-8.7|6.0||||||Treatment effect describes the difference in outcomes between 0.5 mg riociguat and placebo on Day 14. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.||6.0|-8.7|
73868608|NCT00856544|147282075|SUPERIORITY_OR_OTHER||Percent Difference|21.52|||<|0.0001|TWO_SIDED|95.0|12.39|30.65||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||30.65|12.39|<0.0001
73868609|NCT00856544|147282076|SUPERIORITY_OR_OTHER||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.44|-0.26||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.||-0.26|-0.44|<0.0001
73942218|NCT02170025|147416307|OTHER||Bayesian analysis|-5.0|||||TWO_SIDED|90.0|-12.4|2.4||||||Treatment effect describes the difference in outcomes between 1.0 mg riociguat and placebo on Day 28. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.||2.4|-12.4|
73868610|NCT00856544|147282076|SUPERIORITY_OR_OTHER||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.35|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.||-0.16|-0.35|<0.0001
73942219|NCT00572195|147416309|OTHER||Wilson score interval|77.0|||||TWO_SIDED|95.0|71.1|81.9|||||The value is for all serious adverse events, regardless of device relation.||95% confidence interval estimated using the Wilson score interval|81.9|71.1|
73942220|NCT00572195|147416310|OTHER||||||<|0.05||||||For all 6-month periods, from 6 months through 9 years post-implant, p \<0.05.|Wilcoxon Signed Rank Test|||||||<0.05
73942221|NCT00572195|147416312|OTHER||GEE estimated intercept|48.0|||<|0.0001|TWO_SIDED|95.0|46.8|49.2|||Generalized estimating equation (GEE)|||||49.2|46.8|<0.0001
73942222|NCT00572195|147416312|OTHER||Slope|0.0||||0.6729|TWO_SIDED|95.0|-0.2|0.1|||Generalized estimating equation (GEE)|||||0.1|-0.2|0.6729
73942223|NCT04922554|147416334|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in response rates|14.15||||0.2182|TWO_SIDED|||||Nominal p-values are provided for descriptive purposes.|Chi-squared|Analysis stratified by prior NTM antibiotic treatment was not performed due to small sample size in one randomization stratification subgroup.||||||0.2182
73942224|NCT04922554|147416335|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in response rates|22.15||||0.046|TWO_SIDED|||||Nominal p-values are provided for descriptive purposes.|Chi-squared|Analysis stratified by prior NTM antibiotic treatment was not performed due to small sample size in one randomization stratification subgroup.||||||0.0460
73868611|NCT00856544|147282077|SUPERIORITY_OR_OTHER||Percent difference|10.63|||<|0.0001|TWO_SIDED|95.0|5.8|15.45||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||15.45|5.80|<0.0001
73868612|NCT00856544|147282077|SUPERIORITY_OR_OTHER||Percent difference|6.42||||0.0038|TWO_SIDED|95.0|2.07|10.77||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||10.77|2.07|0.0038
73868613|NCT00787189|147282122|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0005||95.0|||||Fisher Exact|||||||<0.0005
73868614|NCT00596830|147282127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.179||||0.064|TWO_SIDED|95.0|0.99|1.404||The p-value stated is the 2-sided p-value from the log rank test stratified by gender, prior adjuvant chemotherapy, and histology.|Log Rank|||||1.404|0.990|0.064
73868615|NCT00596830|147282128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.103||||0.27|TWO_SIDED|95.0|0.925|1.315||2-sided p-value is from the unstratified log-rank test|Log Rank||HR was based on the Cox proportional hazards model|||1.315|0.925|0.270
73868616|NCT00596830|147282129|SUPERIORITY_OR_OTHER||Risk difference|-1.472||||0.685|TWO_SIDED|95.0|-8.6|5.6|||Chi-squared||Risk difference confidence interval was calculated based on a normal distribution.|||5.6|-8.6|0.685
73868617|NCT00880191|147282145|SUPERIORITY_OR_OTHER|||||||0.2344|TWO_SIDED||||||Fisher Exact|||Complete Responders by Arm - Days 2-6, the primary analysis utilizes Fisher's exact test to compare the percentage of complete responders in each group (dex/gabapentin vs. dex/placebo), with complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.||||0.2344
73868618|NCT00880191|147282146|SUPERIORITY_OR_OTHER|||||||0.3694|TWO_SIDED||||||Fisher Exact|||The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale, and no rescue agents.||||0.3694
73868619|NCT01919801|147282171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.633||||||Test was performed using a weighted log-rank test called the Peto-Prentice test with a global 2-sided significance level of 5% after adjusting for stratification factors (race, and severity) in the ITT population.|Adjusted Peto-Prentice|||A total of 121 participants were analysed, however 3 participants did not receive the study medication and were censored at time 0.||||0.633
73868620|NCT01843062|147282181|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8205|TWO_SIDED|95.0|0.61|1.87||The primary endpoint was to be considered statistically significant if the 2-sided p-value was less than 0.05. P-value and confidence intervals (CIs) were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.87|0.61|0.8205
73868621|NCT01843062|147282182|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6549|TWO_SIDED|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.73|0.42|0.6549
73868622|NCT01843062|147282183|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8205|TWO_SIDED|95.0|0.61|1.87||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.87|0.61|0.8205
73974889|NCT03614663|147495635|SUPERIORITY|||||||0.02|||||||MMRM - Mixed model for repeated measures|||||||0.02
73868623|NCT01843062|147282184|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6549|TWO_SIDED|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.73|0.42|0.6549
73868624|NCT01677858|147282185|OTHER||Maximum Tolerated Dose (mg/m²)|70.0|||||TWO_SIDED|||||||||||||
73868625|NCT00773747|147282201|SUPERIORITY||Cox Proportional Hazard|0.774|||=|0.01|TWO_SIDED|95.0|0.636|0.941|||Regression, Cox|||Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.||0.941|0.636|= 0.0100
73974890|NCT03614663|147495636|SUPERIORITY|||||||0.091|||||||MMRM - Mixed model for repeated measures|||||||0.091
73974891|NCT03614663|147495637|SUPERIORITY|||||||0.135|||||||MMRM - Mixed model for repeated measures|||||||0.135
73974892|NCT03614663|147495638|SUPERIORITY|||||||0.056|||||||MMRM - Mixed model for repeated measures|||||||0.056
74089196|NCT01045993|147731449|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint||||0.008
74089197|NCT01045993|147731449|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint||||0.004
74089198|NCT01045993|147731450|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.268
74089199|NCT01045993|147731450|SUPERIORITY_OR_OTHER|||||||0.419||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.419
73868626|NCT00773747|147282203|SUPERIORITY||Cox Proportional Hazard|0.858||||0.3496|TWO_SIDED|95.0|0.622|1.184|||Regression, Cox|||Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.||1.184|0.622|0.3496
73868627|NCT04260347|147282206|OTHER||Risk Ratio (RR)|1.064||||1|TWO_SIDED|95.0|0.345|1.784|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.784|0.345|1.000
73868628|NCT04260347|147282207|OTHER||Risk Ratio (RR)|0.889||||0.254|TWO_SIDED|95.0|0.699|1.08|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.08|0.699|0.254
73868629|NCT04260347|147282208|OTHER||Risk Ratio (RR)|1.089||||0.28|TWO_SIDED|95.0|0.942|1.237|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.237|0.942|0.280
73868630|NCT04260347|147282209|OTHER||Standardized Mean Difference (SMD)|0.016||||0.916|TWO_SIDED|95.0|-0.096|0.128|||Wilcoxon (Mann-Whitney)||SMD = Difference in the mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.128|-0.096|0.916
73868631|NCT04260347|147282210|OTHER||Risk Ratio (RR)|1.066||||0.561|TWO_SIDED|95.0|0.872|1.261|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.261|0.872|0.561
73868632|NCT04260347|147282211|OTHER||Risk Ratio (RR)|1.231||||0.522|TWO_SIDED|95.0|0.707|1.756|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.756|0.707|0.522
73868633|NCT04260347|147282212|OTHER||Standardized Mean Difference (SMD)|-0.021||||0.81|TWO_SIDED|95.0|-0.133|0.091|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.091|-0.133|0.810
73868634|NCT04260347|147282213|OTHER||Standardized Mean Difference (SMD)|-0.085||||0.179|TWO_SIDED|95.0|-0.199|0.03|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.03|-0.199|0.179
73868635|NCT04260347|147282214|OTHER||Standardized Mean Difference (SMD)|0.042||||0.275|TWO_SIDED|95.0|-0.072|0.156|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.156|-0.072|0.275
73868636|NCT03549104|147282228|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
73868637|NCT03549104|147282229|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
73868638|NCT03549104|147282230|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
74009010|NCT01641237|147568704|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.92||||0.8|TWO_SIDED|95.0|-6.25|8.1||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||8.10|-6.25|0.8000
73868639|NCT03078855|147282231|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.26|TWO_SIDED|95.0|0.83|1.98|||Regression, Cox||The EFS hazard ratio was adjusted for enrolling site, continuous age at randomization, and (via stratification) 3 randomization strata: non-follicular histology, follicular (FL) with low/intermediate FLIPI score and FL with high FLIPI score.|||1.98|0.83|0.26
73868640|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.008
73868641|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months||||0.040
73868642|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 months||||0.033
73868643|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.500
73868644|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months||||0.750
73868645|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months||||0.156
73868646|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.938|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.938
73868647|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months||||0.250
73868648|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months||||0.999
73868649|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.057
73868650|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.031
73868651|NCT01846741|147282265|SUPERIORITY_OR_OTHER|||||||0.625|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.625
73868652|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0008
73868653|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0544|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure Score||||0.0544
73868654|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0207|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.0207
73868655|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0163|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.0163
73868656|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.0156
73868657|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.0742
73942225|NCT04922554|147416344|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.8||||0.824|TWO_SIDED|95.0|-6.01|7.52||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||7.52|-6.01|0.8240
73942226|NCT04922554|147416345|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|5.1||||0.2149|TWO_SIDED|95.0|-3.03|13.2||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||13.20|-3.03|0.2149
73942227|NCT04922554|147416346|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|8.3||||0.123|TWO_SIDED|95.0|-2.31|18.88||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||18.88|-2.31|0.1230
74031323|NCT00418262|147616140|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.56|0.52|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.52|-0.56|
73868658|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0884|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.0884
73868659|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0007
73868660|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.1173|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure||||0.1173
73868661|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0214|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery||||0.0214
73868662|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity||||0.0114
73868663|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery||||0.0078
73868664|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0875|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery||||0.0875
73868665|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.1526|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery||||0.1526
73868666|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0031
73868667|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0828|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure||||0.0828
73868668|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0092|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery||||0.0092
73868669|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0096|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity||||0.0096
73868670|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0234|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery||||0.0234
73868671|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0284|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery||||0.0284
73868672|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0679|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery||||0.0679
73868673|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0003
73868674|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0728|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0728
73942228|NCT04922554|147416347|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|5.5||||0.1168|TWO_SIDED|95.0|-1.41|12.43||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||12.43|-1.41|0.1168
73942229|NCT04922554|147416348|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|6.5||||0.0743|TWO_SIDED|95.0|-0.66|13.66||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||13.66|-0.66|0.0743
73974893|NCT00336505|147495652|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|2.0||||0.5667|TWO_SIDED|95.0|-4.8|8.9|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||8.9|-4.8|0.5667
73868675|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.0005
73868676|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.0005
73868677|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.0078
74039440|NCT02528253|147632442|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.17||0.0958|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.05|-0.60|0.0958
73868678|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.0078
73942230|NCT04922554|147416349|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|7.1||||0.0899|TWO_SIDED|95.0|-1.13|15.23||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||15.23|-1.13|0.0899
73868679|NCT01846741|147282266|SUPERIORITY_OR_OTHER|||||||0.0273|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.0273
73868680|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0192|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0192
73868681|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.8069|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.8069
73868682|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.2416|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.2416
73868683|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.1111|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.1111
73868684|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0014
73868685|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.3247|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.3247
73868686|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0826|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0826
73942231|NCT04922554|147416350|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.5||||0.9019|TWO_SIDED|95.0|-7.6|8.59||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||8.59|-7.60|0.9019
73942232|NCT04922554|147416351|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|13.7||||0.0015|TWO_SIDED|95.0|5.43|21.89||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||21.89|5.43|0.0015
73942233|NCT04922554|147416352|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.9||||0.8269|TWO_SIDED|95.0|-7.26|9.05||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison of Omadacycline and Placebo for activity score has been presented.|||9.05|-7.26|0.8269
73942234|NCT04922554|147416352|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-0.2||||0.9584|TWO_SIDED|95.0|-7.74|7.35||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for impact score has been presented|||7.35|-7.74|0.9584
73942235|NCT04922554|147416352|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-5.0||||0.2123|TWO_SIDED|95.0|-12.88|2.92||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for symptom score has been presented.|||2.92|-12.88|0.2123
73942236|NCT04922554|147416352|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-0.8||||0.8161|TWO_SIDED|95.0|-7.58|5.99||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for total score has been presented.|||5.99|-7.58|0.8161
73942237|NCT04922554|147416353|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-5.7||||0.001|TWO_SIDED|95.0|-8.95|-2.38||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||-2.38|-8.95|0.0010
73942238|NCT04922554|147416354|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in improvement rates|39.61||||0.002|TWO_SIDED|95.0|16.66|62.56|||Fisher Exact|||||62.56|16.66|0.0020
73942239|NCT04922554|147416355|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in improvement rates|15.41||||0.3051|TWO_SIDED|95.0|-9.1|39.93|||Fisher Exact|||||39.93|-9.10|0.3051
73942240|NCT04922554|147416356|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.3552|||||||Wilcoxon rank sum test|||||||0.3552
73942241|NCT04922554|147416357|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0753|||||||Wilcoxon rank sum test|||||||0.0753
73942242|NCT04922554|147416359|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Odds Ratio (OR)|3.84||||0.0168|TWO_SIDED|95.0|1.24|11.87|||Chi-squared|||||11.87|1.24|0.0168
73942243|NCT04922554|147416360|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0233|||||||Log Rank|||||||0.0233
73868687|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.1040
73942244|NCT04922554|147416361|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0349|||||||Log Rank|||||||0.0349
73942245|NCT02673398|147416369|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.05|TWO_SIDED|95.0|-0.82|0.01|||t-test, 2 sided||Patients with higher risk scores were more likely to require a dose reduction. The lack of significance is most likely due to the small sample size.|Student's t-test was used to assess if geriatric risk score differed depending on whether or not a participant had a dose reduction (mean difference log2 risk = no dose modification - dose modification).||0.01|-0.82|0.05
73942246|NCT02673398|147416369|SUPERIORITY||Slope|-1.29|STANDARD_ERROR_OF_MEAN|1.44||0.39|TWO_SIDED||||||Regression, Linear|||Linear regression was used to assess whether log2 geriatric toxicity risk score was a risk factor for the number of course completed.||||0.39
73942247|NCT02673398|147416370|SUPERIORITY||Slope|-0.093|STANDARD_ERROR_OF_MEAN|0.0398||0.03|TWO_SIDED||||||Regression, Linear||The older the participant the lower the steady state value.|Least squares regression was used to assess the relationship between steady state neratinib concentration and age||||0.03
73942248|NCT02673398|147416370|SUPERIORITY||Slope|1.4|STANDARD_DEVIATION|2.39||0.57|TWO_SIDED||||||Regression, Linear||Geriatric risk score was not predictive of steady state concentration.|Least squares regression was used to determine if geriatric toxicity risk score at baseline was predictive of steady state neratinib concentration.||||0.57
73942249|NCT01321554|147416371|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.21|||||TWO_SIDED|99.0|0.14|0.31||||||||0.31|0.14|
73868688|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0094
73868689|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.5874|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.5874
73868690|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.1508|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.1508
73868691|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.0136
73868692|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0015
73868693|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.3522|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.3522
73868694|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0240
74031324|NCT00418262|147616141|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.32|0.2|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.20|-0.32|
74039441|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.12||0.0015|TWO_SIDED|95.0|-0.6|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.14|-0.60|0.0015
73868695|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0353|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.0353
73868696|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0361|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0361
73868697|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.1921|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.1921
73868698|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.1639|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.1639
73868699|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.1738|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.1738
73868700|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0401|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0401
73868701|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.2753|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.2753
73868702|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0056|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0056
73868703|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.1173|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.1173
73868704|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0268|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0268
73868705|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.4406|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final||||0.4406
73868706|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.7926|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional Well Being Final||||0.7926
73868707|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0987|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final||||0.0987
73868708|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0361|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final||||0.0361
73868709|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0615|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final||||0.0615
73868710|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0024
73942250|NCT01111123|147416375|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||CI of 95%|Log Rank|||Probabilities of PGA not worsening were estimated using the Kaplan-Meier product limit method with a comparison between treatment group survival curves evaluated by the log-rank test statistic. The Cox proportional hazards model was used to estimate the hazard ratio for worsening of PGA (equivalent to a relative risk adjusted for follow-up time) and a corresponding 95-percent confidence interval.||||<0.05
73942251|NCT01111123|147416376|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Secondary outcomes, including subject self-assessment and signs of psoriasis ratings, were analyzed as continuous dependent variables in these statistical models. Mixed modeling analysis of covariance (ANCOVA) was used to compare the relationships between psoriasis symptoms over time in the placebo and steroid treatment groups||||<0.05
73942252|NCT04676425|147416394|OTHER||Least-Squares Geometric Mean Ratio|1.19|||||TWO_SIDED|90.0|0.7|2.01|||||Moderate hepatic impairment participants represent the numerator and healthy participants represent the denominator in the geometric mean ratio.|||2.01|0.70|
73942253|NCT04676425|147416395|OTHER||Least-Squares Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|0.86|1.74|||||Moderate hepatic impairment participants represent the numerator and healthy participants represent the denominator in the geometric mean ratio.|||1.74|0.86|
73942254|NCT03896009|147416409|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73942255|NCT03896009|147416410|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
73942256|NCT02052310|147416413|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% confidence interval (CI) for the treatment difference in least square (LS) means from MI ANCOVA model between the 2 treatment groups lay entirely above -0.75 g/dL.|LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.053||0.0005|TWO_SIDED|95.0|0.079|0.287|||ANCOVA|ANCOVA with multiple imputation||Treatment comparison was made using the multiple imputation (MI) strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb as a covariate, and treatment, region and cardiovascular/cerebrovascular/thromboembolic medical history (yes vs. no) as factors.||0.287|0.079|0.0005
73942257|NCT02052310|147416414|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|3.5|||||TWO_SIDED|95.0|-0.7|7.7||||||For the difference of responder rates between 2 treatment groups, the CI was analyzed from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||7.7|-0.7|
73974894|NCT00336505|147495654|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|0.3|||>|0.9999||95.0|-4.5|5.1|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||5.1|-4.5|>0.9999
73868711|NCT01846741|147282267|SUPERIORITY_OR_OTHER|||||||0.0155|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.0155
73868712|NCT01846741|147282269|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||3 months||||0.0625
73868713|NCT01846741|147282269|SUPERIORITY_OR_OTHER|||||||0.1094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||6 months||||0.1094
73942258|NCT02052310|147416415|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|4.3|||||TWO_SIDED|95.0|-0.1|8.7||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||8.7|-0.1|
73942259|NCT02052310|147416416|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% CI for the treatment difference in LS means of change from baseline Hb averaged over Weeks 28 to 52 lay entirely above -0.75 g/dL.|LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.067||0.0148|TWO_SIDED|95.0|0.032|0.296|||Mixed Models Analysis|||Treatment comparison was made using mixed model for repeated measures (MMRM) with baseline Hb as a covariate, and treatment, visit, visit-by-treatment interaction and randomization stratification factors except mean qualifying screening hemoglobin (≤8.0 vs. \>8.0 g/dL) as fixed effects.||0.296|0.032|0.0148
73942260|NCT02052310|147416417|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|LS Mean Difference|-18.34|STANDARD_ERROR_OF_MEAN|1.584|<|0.0001|TWO_SIDED|95.0|-21.448|-15.232|||Mixed Models Analysis|||Treatment comparison was made using a MMRM with baseline LDL cholesterol as a covariate, and treatment, visit, visit-by-treatment interaction and randomization stratification factors as fixed effects.||-15.232|-21.448|<0.0001
73974895|NCT00366249|147495661|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railker|-5.5||||||95.0|-11.0|0.1|||||Adjusted for Perfusion, Extent, Depth/tissue loss, Infection, and Sensation (PEDIS) score|Analysis provided for Cure||0.1|-11.0|
73868714|NCT01846741|147282269|SUPERIORITY_OR_OTHER|||||||0.0342|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||12 months||||0.0342
74089200|NCT01045993|147731450|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.086
74089201|NCT01045993|147731451|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.067
73868715|NCT01846741|147282269|SUPERIORITY_OR_OTHER|||||||0.5417|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||18 Months||||0.5417
73942261|NCT02052310|147416418|NON_INFERIORITY|The non-inferiority margin was fixed as a difference of -0.75.|LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.099||0.8178|TWO_SIDED|95.0|-0.171|0.217|||ANCOVA|ANCOVA multiple imputation||Treatment comparison was made using the multiple imputation strategy by combining the results of ANCOVA model with baseline Hb as a covariate, and treatment, region and cardiovascular/cerebrovascular/thromboembolic medical history (yes vs. no) as factors.||0.217|-0.171|0.8178
73942262|NCT02052310|147416419|SUPERIORITY|||||||0.00028||||||Threshold for significance at 0.05 level.|Rank ANCOVA|||Treatment comparison was made using an ANCOVA model with baseline iron repletion status, treatment, and randomization stratification factors as fixed effects.||||0.00028
73942263|NCT02052310|147416420|NON_INFERIORITY|The non-inferiority margin for the difference between groups was 1.8.|Hazard Ratio (HR)|1.26||||0.3284|TWO_SIDED|95.0|0.791|2.016|||Cox Proportional Hazards model|||Analysis was done using a Cox Proportional Hazards model adjusting for baseline Hb and other stratification factors except mean qualifying screening hemoglobin (\<= 8.0 vs. \>8.0 g/dL) as fixed effects.||2.016|0.791|0.3284
73942264|NCT01197508|147416492|SUPERIORITY_OR_OTHER||LS mean|1.1|STANDARD_ERROR_OF_MEAN|0.84||1|TWO_SIDED|95.0|-0.53|2.79||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.79|-0.53|1.000
73942265|NCT01197508|147416492|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|95.0|-1.22|2.13|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.13|-1.22|1.000
73942266|NCT01197508|147416492|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.88||1|TWO_SIDED|95.0|-1.21|2.22|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-1.21|1.000
74031325|NCT00418262|147616141|SUPERIORITY||Median Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.64|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.39|-0.64|
74031326|NCT00418262|147616142|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-0.28|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.24|-0.28|
74031327|NCT00418262|147616142|SUPERIORITY||Mean Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.57|0.47|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.47|-0.57|
74031328|NCT00418262|147616143|SUPERIORITY||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.32|-0.21|
74031329|NCT00418262|147616143|SUPERIORITY||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.32|-0.21|
73868716|NCT00360568|147282295|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73868717|NCT00360568|147282296|SUPERIORITY_OR_OTHER|||||||0.394|||||||t-test, 2 sided|||||||0.394
73868718|NCT00360568|147282297|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73868719|NCT00360568|147282298|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74089202|NCT01045993|147731451|SUPERIORITY_OR_OTHER|||||||0.757||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.757
73868720|NCT00360568|147282299|SUPERIORITY_OR_OTHER|||||||0.055|||||||t-test, 2 sided|||||||0.055
73868721|NCT00360568|147282300|SUPERIORITY_OR_OTHER|||||||0.766|||||||t-test, 2 sided|||||||0.766
73868722|NCT00360568|147282301|SUPERIORITY_OR_OTHER|||||||0.571|||||||t-test, 2 sided|||||||0.571
73868723|NCT00360568|147282302|SUPERIORITY_OR_OTHER|||||||0.583|||||||t-test, 2 sided|||||||0.583
73868724|NCT00360568|147282303|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73868725|NCT00360568|147282304|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.670
73868726|NCT00360568|147282305|SUPERIORITY_OR_OTHER|||||||0.341|||||||t-test, 2 sided|||||||0.341
73868727|NCT00360568|147282306|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.220
73868728|NCT00360568|147282307|SUPERIORITY_OR_OTHER|||||||0.174|||||||t-test, 2 sided|||||||0.174
73868729|NCT00360568|147282308|SUPERIORITY_OR_OTHER|||||||0.259|||||||t-test, 2 sided|||||||0.259
73868730|NCT00360568|147282309|SUPERIORITY_OR_OTHER|||||||0.922|||||||t-test, 2 sided|||||||0.922
73868731|NCT00360568|147282310|SUPERIORITY_OR_OTHER|||||||0.258|||||||t-test, 2 sided|||||||0.258
73942267|NCT01197508|147416493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.17||0.144|TWO_SIDED|95.0|0.45|1.12|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.12|0.45|0.144
74089203|NCT01045993|147731451|SUPERIORITY_OR_OTHER|||||||0.219||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.219
74089204|NCT01045993|147731452|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.043
73868732|NCT00360568|147282311|SUPERIORITY_OR_OTHER|||||||0.104|||||||t-test, 2 sided|||||||0.104
73868733|NCT00360568|147282312|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.650
73868734|NCT00360568|147282313|SUPERIORITY_OR_OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
73868735|NCT00360568|147282314|SUPERIORITY_OR_OTHER|||||||0.459|||||||t-test, 2 sided|||||||0.459
73868736|NCT00360568|147282315|SUPERIORITY_OR_OTHER|||||||0.899|||||||t-test, 2 sided|||||||0.899
73868737|NCT03824587|147282317|SUPERIORITY||Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|0.182||0.0004|TWO_SIDED|99.0|-1.13|-0.18|||Mixed Models Analysis|||||-0.18|-1.13|0.0004
73868738|NCT03824587|147282318|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0097|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0097
73868739|NCT03824587|147282319|SUPERIORITY|||||||0.0027|||||||ANOVA|||||||0.0027
73868740|NCT03824587|147282320|SUPERIORITY|||||||0.0011|||||||ANOVA|||||||0.0011
73868741|NCT00986362|147282321|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.613||||0.679|TWO_SIDED|95.0|0.07|4.509|||Fisher Exact|||||4.509|0.070|0.679
73868742|NCT01211340|147282339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.18
73868743|NCT01211340|147282339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Regression, Linear|No significant difference found between groups||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.18
73868744|NCT01211340|147282339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Spearmans rank|No differences found||To test the effects of the dose of meetings on association with overall Caregiver Perceptions of Pain Medicine Questionaire (CPMQ) change we used Spearman rank correlation coefficient||||.18
73868745|NCT01211340|147282340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED|95.0|||||Wilcxon Rank Sum Test|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.15
73868746|NCT01211340|147282340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.15
73868747|NCT01211340|147282341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.89
73942268|NCT01197508|147416493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.17||0.203|TWO_SIDED|95.0|0.47|1.17|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.17|0.47|0.203
74089205|NCT01045993|147731452|SUPERIORITY_OR_OTHER|||||||0.388||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.388
73868748|NCT01211340|147282341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.89
73868749|NCT03755661|147282342|OTHER|pilot data to estimate effect size f-squared as the parameter as primary outcome||||||0.048||||||provide inferential statistics for data completion. Study is not designed to detect significant differences between groups|Regression, Linear|R-square change = .12; F-change (1, 20) = 4.44||pilot study to calculate effect size, study is not powered to detect significant group differences|"Computed f-squared as effect size estimate where baseline value of heavy drinking episodes entered in step 1 and condition in step 2~f- squared = .22"|||.048
73868750|NCT03755661|147282343|SUPERIORITY|"The main outcome variable is f-squared as an estimate of differences between conditions controlling for baseline value.~A statistical test is provided only for completeness as this study is not powered to detect significant effects"||||||0.34||||||F-change (1, 20) = 0.97|Regression, Linear|||pilot trial to compute effect size estimate|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04|||.34
73868751|NCT03755661|147282344|SUPERIORITY|This is a pilot trial to estimate effect sizes and not powered to detect significant differences||||||0.2||||||data provided for completeness, not powered to test differences|Regression, Linear|F-change (1, 20) = 1.80|||Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .058|||.20
73868752|NCT03755661|147282345|SUPERIORITY|Pilot trial not powered to detect significant group differences. Data from analyses presented for completeness. Primary outcome is effect size estimates||||||0.19|||||||Regression, Linear|F-change (1, 20) = 1.83||Pilot trial not powered to detect significant group differences|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .048|||.19
73868753|NCT03755661|147282346|SUPERIORITY|||||||0.26||||||F-change (1, 19) = 1.34|Regression, Linear|||Not powered to test significant differences. provide data on effect size estimate below|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04|||.26
73868754|NCT04167137|147282375|OTHER|||||||||||||||||Because only 1 participant experienced a DLT (Grade 3 cytokine release syndrome in Arm 1 Cohort 6), no MTD could be reached.|Because only 1 participant experienced a DLT (Grade 3 cytokine release syndrome in Arm 1 Cohort 6), no MTD could be reached.|||
73868755|NCT02964767|147282414|OTHER||||||<|0.049|||||||t-test, 2 sided|||||||<0.049
73868756|NCT04412707|147282415|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.946|||||TWO_SIDED|90.0|0.849|1.053|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.053|0.849|
73868757|NCT04412707|147282416|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.952|||||TWO_SIDED|90.0|0.861|1.053|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.053|0.861|
73868758|NCT04412707|147282417|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.955|||||TWO_SIDED|90.0|0.863|1.058|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.058|0.863|
73868759|NCT04412707|147282419|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.948|||||TWO_SIDED|90.0|0.736|1.222|||||CVC vs PVC CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|For melflufen: Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.222|0.736|
73942269|NCT01197508|147416493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.12||0.005|TWO_SIDED|95.0|0.32|0.82|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.82|0.32|0.005
73974896|NCT00366249|147495663|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.7||||||95.0|-12.3|-1.1|||||Adjusted for PEDIS score|Analysis provided for Cure||-1.1|-12.3|
74031330|NCT00418262|147616144|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.36|0.13|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.13|-0.36|
74031331|NCT00418262|147616144|SUPERIORITY||Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.72|0.27|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.27|-0.72|
74031332|NCT00418262|147616145|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.19|
74031333|NCT00418262|147616145|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.19|
74031334|NCT00418262|147616146|SUPERIORITY||Mean Difference (Net)|-7.4|||||TWO_SIDED|95.0|-7.76|-7.04|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||-7.04|-7.76|
74031335|NCT00418262|147616146|SUPERIORITY||Mean Difference (Net)|-2.44|||||TWO_SIDED|95.0|-3.03|-1.9|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||-1.90|-3.03|
74039442|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.12||0.0004|TWO_SIDED|95.0|-0.65|-0.19|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.19|-0.65|0.0004
73868760|NCT04412707|147282419|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|[adjusted geometric mean ratio (GMR)]|0.846|||||TWO_SIDED|90.0|0.748|0.957|||||CVC vs PVC CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|For desmethyl-melflufen: Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.957|0.748|
73942270|NCT01197508|147416494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.22||0.636|TWO_SIDED|95.0|0.54|1.45|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.45|0.54|0.636
73942271|NCT01197508|147416494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|STANDARD_ERROR_OF_MEAN|0.19||0.215|TWO_SIDED|95.0|0.44|1.2|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.20|0.44|0.215
73942272|NCT01197508|147416494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|STANDARD_ERROR_OF_MEAN|0.15||0.034|TWO_SIDED|95.0|0.35|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.96|0.35|0.034
73942273|NCT01197508|147416495|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.37||0.711|TWO_SIDED|95.0|0.36|1.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.99|0.36|0.711
73942274|NCT01197508|147416495|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.34||0.594|TWO_SIDED|95.0|0.34|1.85|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.85|0.34|0.594
73942275|NCT01197508|147416495|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|STANDARD_ERROR_OF_MEAN|0.49||0.749|TWO_SIDED|95.0|0.5|2.65|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.65|0.50|0.749
73942276|NCT01197508|147416496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.16||0.037|TWO_SIDED|95.0|0.28|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.96|0.28|0.037
73942277|NCT01197508|147416496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.21||0.222|TWO_SIDED|95.0|0.38|1.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.25|0.38|0.222
73942278|NCT01197508|147416496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.17||0.042|TWO_SIDED|95.0|0.28|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.98|0.28|0.042
73974897|NCT00366249|147495665|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.3||||||95.0|-13.6|1.0|||||Adjusted for PEDIS score|||1.0|-13.6|
73942279|NCT01197508|147416497|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.41||0.913|TWO_SIDED|95.0|0.48|2.27|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.27|0.48|0.913
73942280|NCT01197508|147416497|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.37||0.841|TWO_SIDED|95.0|0.42|2.01|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.01|0.42|0.841
73942281|NCT01197508|147416497|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61|STANDARD_ERROR_OF_MEAN|0.26||0.239|TWO_SIDED|95.0|0.26|1.39|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.39|0.26|0.239
73942282|NCT01197508|147416498|SUPERIORITY_OR_OTHER||LS mean|1.1|STANDARD_ERROR_OF_MEAN|0.705||0.12|TWO_SIDED|95.0|-0.288|2.481|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.481|-0.288|0.120
73942283|NCT01197508|147416498|SUPERIORITY_OR_OTHER||LS mean|0.95|STANDARD_ERROR_OF_MEAN|0.715||0.184|TWO_SIDED|95.0|-0.452|2.354|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.354|-0.452|0.184
73942284|NCT01197508|147416498|SUPERIORITY_OR_OTHER||LS mean|2.09|STANDARD_ERROR_OF_MEAN|0.711||0.003|TWO_SIDED|95.0|0.692|3.484|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||3.484|0.692|0.003
73942285|NCT01197508|147416499|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.131||95.0|-0.05|0.42|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.42|-0.05|0.131
73974898|NCT01561300|147495666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.09|TWO_SIDED|95.0|-2.16|0.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea-placebo|Null hypothesis: no difference between Tea and Control.||0.17|-2.16|0.09
73974899|NCT01561300|147495667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.7|TWO_SIDED|95.0|-2.44|1.66|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea- Control|Null hypothesis: no difference between Tea and Control.||1.66|-2.44|0.70
73868761|NCT04412707|147282420|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.877|||||TWO_SIDED|90.0|0.684|1.126|||||Data above refer to meflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.126|0.684|
73868762|NCT04412707|147282420|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.897|||||TWO_SIDED|90.0|0.819|0.982|||||Data above refer to desethyl-melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.982|0.819|
73942286|NCT01197508|147416499|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.551|TWO_SIDED|95.0|-0.17|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.31|-0.17|0.551
73942287|NCT01197508|147416499|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.645|TWO_SIDED|95.0|-0.19|0.3|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.30|-0.19|0.645
73942288|NCT01197508|147416500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.046|TWO_SIDED|95.0|0.38|0.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||0.99|0.38|0.046
73942289|NCT01197508|147416500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.051|TWO_SIDED|95.0|0.38|1.0|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.00|0.38|0.051
73942290|NCT01197508|147416500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.15||0.04|TWO_SIDED|95.0|0.37|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||0.98|0.37|0.040
73942291|NCT01197508|147416501|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.66||0.273|TWO_SIDED|95.0|-0.58|2.03|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.03|-0.58|0.273
73974900|NCT01561300|147495668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.66|TWO_SIDED|95.0|-1.15|0.75||Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Mixed Models Analysis||Tea-placebo|Null hypothesis: no difference between Tea and Control.||0.75|-1.15|0.66
73974901|NCT00724126|147495672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.03
73974902|NCT00724126|147495673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.02
73974903|NCT00571649|147495682|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.771||||0.0211||95.0|0.618|0.962||Hochberg procedure: A 2-sided p-value of less than 0.05 would be considered significant, if the 1-sided p-value of the other primary efficacy outcome measure was less than 0.025, elsewise a p-value of less than 0.025 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (91.4% for superiority) with 4% event rate at day 35 for comparator and 40% relative risk reduction.||0.962|0.618|0.0211
73974904|NCT00571649|147495683|NON_INFERIORITY_OR_EQUIVALENCE|Rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI (Confidence Interval) was less than 1.5|Risk Ratio (RR)|0.968||||0.0025||95.0|0.713|1.314||Hochberg procedure: A 1-sided p-value of less than 0.025 would be considered significant, if the 2-sided p-value of the other primary efficacy outcome measure was less than 0.05, elsewise a p-value of less than 0.0125 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (98.6% power for non-inferiority) with 1.8% event rate at day 10 for comparator and 35% relative risk reduction.||1.314|0.713|0.0025
74089206|NCT01045993|147731452|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.039
74089207|NCT01045993|147731453|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.797
73942292|NCT01197508|147416501|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.67||0.315|TWO_SIDED|95.0|-0.65|2.0|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.00|-0.65|0.315
73942293|NCT01197508|147416501|SUPERIORITY_OR_OTHER||LS mean|1.2|STANDARD_ERROR_OF_MEAN|0.67||0.078|TWO_SIDED|95.0|-0.13|2.51|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.51|-0.13|0.078
73942294|NCT01197508|147416502|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.47||0.59|TWO_SIDED|95.0|-0.68|1.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.19|-0.68|0.590
73942295|NCT01197508|147416502|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.48||0.679|TWO_SIDED|95.0|-0.74|1.14|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.14|-0.74|0.679
73942296|NCT01197508|147416502|SUPERIORITY_OR_OTHER||LS mean|0.6|STANDARD_ERROR_OF_MEAN|0.48||0.215|TWO_SIDED|95.0|-0.35|1.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.53|-0.35|0.215
73868763|NCT04412707|147282421|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.877|||||TWO_SIDED|90.0|0.684|1.124|||||Data above refer to melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence \& administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.124|0.684|
73868764|NCT04412707|147282421|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.908|||||TWO_SIDED|90.0|0.833|0.989|||||Data above refer to desethyl-melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence \& administration route as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.989|0.833|
73868765|NCT01370265|147282435|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||Statistical analysis for hyperemic global MBF between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05.||||0.14
73868766|NCT01370265|147282437|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||Statistical analysis for Cardiac Flow Rate (CFR) between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05||||0.21
73942297|NCT01197508|147416503|SUPERIORITY_OR_OTHER||LS mean|1.2|STANDARD_ERROR_OF_MEAN|0.61||0.052|TWO_SIDED|95.0|-0.01|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.38|-0.01|0.052
73942298|NCT01197508|147416503|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.874|TWO_SIDED|95.0|-1.11|1.3|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.30|-1.11|0.874
73868767|NCT01370265|147282438|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention), for Hyperemic MBF Anterior, alpha level of 0.05.||||0.57
73868768|NCT01370265|147282438|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Septum, alpha level of 0.05.||||0.13
73942299|NCT01197508|147416503|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.099|TWO_SIDED|95.0|-0.19|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.24|-0.19|0.099
73942300|NCT01197508|147416504|SUPERIORITY_OR_OTHER||LS mean|0.6|STANDARD_ERROR_OF_MEAN|0.69||0.394|TWO_SIDED|95.0|-0.77|1.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.95|-0.77|0.394
73974905|NCT00571649|147495684|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.931||||0.3758||95.0|0.795|1.091||Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the two primary efficacy outcome measures were significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||||1.091|0.795|0.3758
73868769|NCT01370265|147282438|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention)for Hyperemic MBF Inferior, alpha level of 0.05.||||0.44
73868770|NCT01370265|147282438|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Lateral, alpha level of 0.05.||||0.74
73942301|NCT01197508|147416504|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.712|TWO_SIDED|95.0|-1.11|1.63|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.63|-1.11|0.712
73868771|NCT01370265|147282439|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Anterior, alpha level of 0.05.||||0.78
73868772|NCT01370265|147282439|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Septum, alpha level of 0.05||||0.42
73868773|NCT01370265|147282439|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Inferior, alpha level of 0.05||||0.96
73868774|NCT01370265|147282439|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Lateral, alpha level of 0.05.||||0.13
73868775|NCT01370265|147282440|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for resting heart rate, alpha level of 0.05.||||0.28
73868776|NCT01370265|147282440|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for hyperemic heart rate, alpha level of 0.05.||||0.51
73942302|NCT01197508|147416504|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.71||0.167|TWO_SIDED|95.0|-0.41|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.38|-0.41|0.167
73942303|NCT01197508|147416505|SUPERIORITY_OR_OTHER||LS mean|1.5|STANDARD_ERROR_OF_MEAN|0.75||0.046|TWO_SIDED|95.0|0.02|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||2.95|0.02|0.046
73868777|NCT01370265|147282441|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for systolic blood pressure, alpha level of 0.05.||||0.31
73868778|NCT01370265|147282441|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for diastolic blood pressure, alpha level of 0.05.||||0.08
73942304|NCT01197508|147416505|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.681|TWO_SIDED|95.0|-1.17|1.79|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.79|-1.17|0.681
73942305|NCT01197508|147416505|SUPERIORITY_OR_OTHER||LS mean|1.3|STANDARD_ERROR_OF_MEAN|0.77||0.087|TWO_SIDED|95.0|-0.19|2.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.84|-0.19|0.087
74089208|NCT01045993|147731454|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.371
73868779|NCT01732770|147282445|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The lower bound of the 2-sided 95% confidence interval (CI) of (denosumab - zoledronic acid) was compared with the non-inferiority margin of -0.46% for assessing non-inferiority.|Treatment Difference|2.1|||<|0.0001|TWO_SIDED|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.||2.6|1.6|<0.0001
73868780|NCT01732770|147282446|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The lower bound of the 2-sided 95% CI) of (denosumab - zoledronic acid) was compared with the non-inferiority margin of -0.51% for assessing non-inferiority.|Treatment Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.||1.7|1.0|<0.0001
73868781|NCT01732770|147282447|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.1|||<|0.0001|TWO_SIDED|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.||2.6|1.6|<0.0001
73868782|NCT01732770|147282448|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.||1.7|1.0|<0.0001
74089209|NCT01045993|147731455|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.122
73868783|NCT00125957|147282449|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the mean change MADRS score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups||||.04
73868784|NCT00125957|147282450|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the median HAM-D score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups||||0.09
73868785|NCT02391363|147282488|SUPERIORITY|||||||0.77||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.08 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate of .05."||||0.77
73868786|NCT02391363|147282489|SUPERIORITY|||||||0.07||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.50 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.07
73942306|NCT01197508|147416506|SUPERIORITY_OR_OTHER||LS mean|0.98|STANDARD_ERROR_OF_MEAN|0.736||1|TWO_SIDED|95.0|-0.464|2.427||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.427|-0.464|1.000
73868787|NCT02391363|147282490|SUPERIORITY|||||||0.34||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.92. (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.34
73942307|NCT01197508|147416506|SUPERIORITY_OR_OTHER||LS mean|0.72|STANDARD_ERROR_OF_MEAN|0.746||1|TWO_SIDED|95.0|-0.74|2.188||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.188|-0.740|1.000
73942308|NCT01197508|147416506|SUPERIORITY_OR_OTHER||LS mean|0.85|STANDARD_ERROR_OF_MEAN|0.762||1|TWO_SIDED|95.0|-0.649|2.346||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.346|-0.649|1.000
73942309|NCT01197508|147416507|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.914|TWO_SIDED|95.0|-0.54|0.61|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.61|-0.54|0.914
73868788|NCT02391363|147282491|SUPERIORITY|||||||0.08||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.08
73942310|NCT01197508|147416507|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.446|TWO_SIDED|95.0|-0.36|0.81|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.81|-0.36|0.446
73942311|NCT01197508|147416507|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.656|TWO_SIDED|95.0|-0.47|0.75|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.75|-0.47|0.656
73942312|NCT01197508|147416508|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.248|TWO_SIDED|95.0|-0.21|0.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.82|-0.21|0.248
73942313|NCT01197508|147416508|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.498|TWO_SIDED|95.0|-0.34|0.7|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.70|-0.34|0.498
73868789|NCT02391363|147282492|SUPERIORITY|||||||0.45||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.59 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.45
73942314|NCT01197508|147416508|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.441|TWO_SIDED|95.0|-0.32|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.74|-0.32|0.441
73942315|NCT01197508|147416509|SUPERIORITY_OR_OTHER||LS mean|0.4|STANDARD_ERROR_OF_MEAN|0.26||0.174|TWO_SIDED|95.0|-0.16|0.87|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.87|-0.16|0.174
73942316|NCT01197508|147416509|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.402|TWO_SIDED|95.0|-0.3|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.74|-0.30|0.402
73942317|NCT01197508|147416509|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.197|TWO_SIDED|95.0|-0.18|0.88|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.88|-0.18|0.197
73942318|NCT01197508|147416510|SUPERIORITY_OR_OTHER||LS mean|-1.47|STANDARD_ERROR_OF_MEAN|1.643||0.371|TWO_SIDED|95.0|-4.697|1.756|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.756|-4.697|0.371
73942319|NCT01197508|147416510|SUPERIORITY_OR_OTHER||LS mean|-1.32|STANDARD_ERROR_OF_MEAN|1.672||0.432|TWO_SIDED|95.0|-4.597|1.967|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.967|-4.597|0.432
73942320|NCT01197508|147416510|SUPERIORITY_OR_OTHER||LS mean|-2.71|STANDARD_ERROR_OF_MEAN|1.672||0.105|TWO_SIDED|95.0|-5.992|0.573|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.573|-5.992|0.105
73942321|NCT01197508|147416511|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.312|TWO_SIDED|95.0|-0.29|0.09|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.09|-0.29|0.312
73942322|NCT01197508|147416511|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.885|TWO_SIDED|95.0|-0.18|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.21|-0.18|0.885
73942323|NCT01197508|147416511|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.067|TWO_SIDED|95.0|-0.37|0.01|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.01|-0.37|0.067
73942324|NCT01197508|147416512|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.152|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.05|-0.33|0.152
73942325|NCT01197508|147416512|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.078|TWO_SIDED|95.0|-0.37|0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.02|-0.37|0.078
73942326|NCT01197508|147416512|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.41|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||-0.02|-0.41|0.033
73942327|NCT01197508|147416513|SUPERIORITY_OR_OTHER||LS mean|-0.011|STANDARD_ERROR_OF_MEAN|0.0181||0.543|TWO_SIDED|95.0|-0.0465|0.0245||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0245|-0.0465|0.543
73942328|NCT01197508|147416513|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.0183||0.998|TWO_SIDED|95.0|-0.036|0.0361||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0361|-0.0360|0.998
73942329|NCT01197508|147416513|SUPERIORITY_OR_OTHER||LS mean|-0.006|STANDARD_ERROR_OF_MEAN|0.0188||0.743|TWO_SIDED|95.0|-0.0432|0.0308||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0308|-0.0432|0.743
73974906|NCT00571649|147495685|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.991||||0.9473||95.0|0.753|1.304||"Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the 2 primary efficacy outcomes and for Composite endpoint of VTE (any DVT, non fatal PE) and all-cause mortality up to Day 35 + 6 days were significant."|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||||1.304|0.753|0.9473
73868790|NCT02391363|147282493|SUPERIORITY|||||||0.13||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.37 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.13
73868791|NCT02391363|147282494|SUPERIORITY|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.52
73868792|NCT02391363|147282495|SUPERIORITY|||||||0.29||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.14 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.29
73942330|NCT01197508|147416513|SUPERIORITY_OR_OTHER||LS mean|-2.3|STANDARD_ERROR_OF_MEAN|1.95||0.244|TWO_SIDED|95.0|-6.1|1.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.56|-6.10|0.244
73942331|NCT01197508|147416513|SUPERIORITY_OR_OTHER||LS mean|-1.7|STANDARD_ERROR_OF_MEAN|1.98||0.389|TWO_SIDED|95.0|-5.59|2.18||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.18|-5.59|0.389
73942332|NCT01197508|147416513|SUPERIORITY_OR_OTHER||LS mean|-2.8|STANDARD_ERROR_OF_MEAN|2.02||0.165|TWO_SIDED|95.0|-6.79|1.16||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.16|-6.79|0.165
73942333|NCT01301391|147416530|SUPERIORITY||Single proportion|0.54|||<|0.001|TWO_SIDED|95.0|0.33|0.74||A priori threshold for statistical significance = 0.05|Fisher Exact|||H0:p≤ 25% vs H1:p\> 25% with an interesting PFS-3 rate of 50% (median PFS of 3 months), alpha=0.05 and beta=0.10, 30 evaluable patients are required for a single stage trial. If at the end of the trial 12 or more out of 30 evaluable patients are alive and progression-free at 3 months since the treatment start date, the null hypothesis are rejected. A Fleming multiple-testing procedure is applied. If \>=4 successes out of the first 15 patients are observed, accrual will continue up to 30.||0.74|0.33|<0.001
73942334|NCT02629991|147416541|SUPERIORITY|||||||0.059||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.059
73942335|NCT02629991|147416542|SUPERIORITY|||||||0.088||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.088
73942336|NCT02629991|147416543|SUPERIORITY|||||||0.027|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.027
73942337|NCT02629991|147416544|SUPERIORITY|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.16|||||||Mixed effects model|||||||0.16
73942338|NCT02629991|147416545|SUPERIORITY|||||||0.69|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.69
73942339|NCT02629991|147416546|SUPERIORITY|||||||0.034||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.034
73942340|NCT02629991|147416547|SUPERIORITY|||||||0.009|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.009
73942341|NCT02629991|147416548|SUPERIORITY|||||||0.033|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.033
73974907|NCT00571649|147495694|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.455|||<|0.0001|TWO_SIDED|95.0|1.854|3.251||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||There was no sample size estimation as this was not planed as confirmatory analysis||3.251|1.854|<0.0001
73974908|NCT00571649|147495695|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.272|||<|0.0001|TWO_SIDED|95.0|1.628|3.171||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|||There was no sample size estimation as this was not planed as confirmatory analysis||3.171|1.628|<0.0001
73974909|NCT03983434|147495703|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.62|||||||Kruskal-Wallis|||||||.62
73974910|NCT03983434|147495704|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.17|||||||Kruskal-Wallis|||||||0.17
73868793|NCT02391363|147282496|SUPERIORITY|||||||0.14||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.19 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.14
73868794|NCT02391363|147282497|SUPERIORITY|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.30 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.59
73868795|NCT02391363|147282498|SUPERIORITY|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.22 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.64
73868796|NCT02391363|147282499|SUPERIORITY|||||||0.35||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.88 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.35
73868797|NCT02391363|147282500|SUPERIORITY|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.52
73868798|NCT02391363|147282501|SUPERIORITY|||||||0.92||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = .01(Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.92
73868799|NCT02391363|147282502|SUPERIORITY|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.29 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.59
73868800|NCT02391363|147282503|SUPERIORITY|||||||0.89||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.89
73868801|NCT02391363|147282504|SUPERIORITY|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.23 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.64
73942342|NCT02629991|147416549|SUPERIORITY|||||||0.78|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.78
73974911|NCT03983434|147495705|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.17|||||||Kruskal-Wallis|||||||0.17
73974912|NCT03983434|147495706|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.079|||||||Kruskal-Wallis|||||||0.079
73974913|NCT03983434|147495707|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.47|||||||Kruskal-Wallis|||||||0.47
73868802|NCT02391363|147282505|SUPERIORITY|||||||0.94||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.94
73868803|NCT02391363|147282506|SUPERIORITY|||||||0.98||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.98
73868804|NCT02391363|147282507|SUPERIORITY|||||||0.88||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.88
73868805|NCT02391363|147282508|SUPERIORITY|||||||0.31||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.31
73868806|NCT02391363|147282509|SUPERIORITY|||||||0.96||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.96
73868807|NCT02391363|147282510|SUPERIORITY|"We expected to reject the null hypothesis of no treatment group difference in 6 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||||0.52||||||Parameter estimate for treatment group = 0.40 (SE = 0.63). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||||||0.52
73868808|NCT02391363|147282511|SUPERIORITY|||||||0.04||||||Parameter estimate for treatment group = 1.79 (SE = 0.85). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.04
73868809|NCT02391363|147282512|SUPERIORITY|||||||0.04||||||Parameter estimate for treatment group = 1.56 (SE = 0.74). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.04
73942343|NCT02629991|147416550|SUPERIORITY|||||||0.53|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.53
73974914|NCT03983434|147495709|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.03|||||||Kruskal-Wallis|||||||0.03
74089210|NCT01045993|147731456|SUPERIORITY_OR_OTHER|||||||0.355||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.355
73974915|NCT03983434|147495710|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.14|||||||Kruskal-Wallis|||||||0.14
74089211|NCT01045993|147731456|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.371
74089212|NCT01045993|147731456|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-values from ANOVA model with treatment treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.216
74089213|NCT01045993|147731457|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.054
73942344|NCT02799784|147416551|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the (UMEC/VI 62.5/25 mcg versus TIO/OLO 5/5 mcg) treatment difference is above -50 milliliter then UMEC/VI 62.5/25 mcg was to be considered non-inferior to TIO/OLO 5/5 mcg.|Mean Difference (Final Values)|0.053|||<|0.001|TWO_SIDED|95.0|0.026|0.08|||Mixed Models Analysis|||||0.080|0.026|<0.001
73942345|NCT02570126|147416557|NON_INFERIORITY|Criterion for the Varilrix HSA-free vaccine as compared to Varilrix™ vaccine, the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (VAR\_HSA\_F minus VAR) in incidence of fever \> 39.0°C (\> 102.2°F) within 0-14 days after Dose 1 was to be equal to or below 5%|Difference in percentage between groups|-1.29|||||TWO_SIDED|95.0|-3.72|1.08|||||Power obtained using PASS 2005 (Likelihood Score \[Miettinen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=2.5%|Non-inferiority of Varilrix HSA-free vaccine to Varilrix™ vaccine in terms of percentage of subjects reporting fever \> 39.0°C (\> 102.2°F) within 15-days (Days 0-14) after Dose 1 (VAR\_HSA\_F Group minus VAR Group)||1.08|-3.72|
73942346|NCT00917579|147416567|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|95.34||||||90.0|91.33|99.52|||ANOVA|Values were back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||99.52|91.33|
73942347|NCT00917579|147416568|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both the AUCinf and Cmax fell within (80%, 125%). AUCinf method of determination includes AUC last calculated value.|ratio of adjusted geometric means|95.79||||||90.0|91.07|100.76|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||100.76|91.07|
73942348|NCT00917579|147416569|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|91.41||||||90.0|83.39|100.2|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||100.20|83.39|
73942349|NCT02740049|147416606|SUPERIORITY|||||||0.0002||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.||||0.0002
73942350|NCT02740049|147416607|SUPERIORITY|||||||0.3994||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or Wilcoxon signed rank test as appropriate.||||0.3994
73942351|NCT02740049|147416608|SUPERIORITY|||||||0.0104||||||P value is the comparison between the IFN/TNF induction group versus VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical difference is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.||||0.0104
73942352|NCT00995501|147416626|SUPERIORITY||Odds Ratio (OR)|0.96||||0.86|TWO_SIDED|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control||2|0.45|0.86
73942353|NCT00995501|147416626|SUPERIORITY||Odds Ratio (OR)|0.96||||0.87|TWO_SIDED|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo||2|0.45|0.87
73942354|NCT00995501|147416626|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9|TWO_SIDED|99.6|0.49|2.2|||Regression, Logistic|||Compare 4 arms with light anesthesia vs. 4 arms with deep anesthesia||2.2|0.49|0.90
73942355|NCT00995501|147416627|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8|TWO_SIDED|99.6|0.37|2.3|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control||2.3|0.37|0.8
73942356|NCT00995501|147416627|SUPERIORITY||Odds Ratio (OR)|1.1||||0.84|TWO_SIDED|99.6|0.43|2.7|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo||2.7|0.43|0.84
73942357|NCT00995501|147416627|SUPERIORITY||Odds Ratio (OR)|1.1||||0.87|TWO_SIDED|99.6|0.42|2.7|||Regression, Logistic|||||2.7|0.42|0.87
73974916|NCT03983434|147495711|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.074|||||||Kruskal-Wallis|||||||0.074
73942358|NCT01755702|147416687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.284|TWO_SIDED|95.0|0.83|1.9|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.90|0.83|0.2840
73942359|NCT01755702|147416687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.2008|TWO_SIDED|95.0|0.86|2.01|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||2.01|0.86|0.2008
73974917|NCT03983434|147495712|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
73974918|NCT03983434|147495713|OTHER|||||||0.17|||||||Kruskal-Wallis|||||||0.17
73868810|NCT02391363|147282513|SUPERIORITY|||||||0.001||||||Parameter estimate for treatment group = 2.96 (SE = 0.91). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.001
73942360|NCT01755702|147416687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.4552|TWO_SIDED|95.0|0.78|1.74|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.74|0.78|0.4552
73942361|NCT01755702|147416687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.5579|TWO_SIDED|95.0|0.75|1.71|||Cox Proportional Hazard Model|||||1.71|0.75|0.5579
73942362|NCT01755702|147416687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.7214|TWO_SIDED|95.0|0.72|1.61|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.61|0.72|0.7214
73942363|NCT01755702|147416687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.8192|TWO_SIDED|95.0|0.62|1.45|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.45|0.62|0.8192
73942364|NCT03786952|147416713|SUPERIORITY|||||||0.453|||||||ANOVA|||||||0.453
73942365|NCT03786952|147416714|SUPERIORITY|||||||0.931|||||||ANOVA|||||||0.931
73942366|NCT03786952|147416715|SUPERIORITY|||||||0.923|||||||ANOVA|||||||0.923
73942367|NCT03786952|147416716|SUPERIORITY|||||||0.399|||||||ANOVA|||||||0.399
73942368|NCT03786952|147416717|SUPERIORITY|||||||0.872|||||||ANOVA|||||||0.872
73942369|NCT03786952|147416718|SUPERIORITY|||||||0.998|||||||ANOVA|||||||0.998
73942370|NCT03786952|147416719|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
73942371|NCT03786952|147416720|SUPERIORITY|||||||0.992|||||||ANOVA|||||||0.992
73942372|NCT03786952|147416721|SUPERIORITY|||||||0.519|||||||ANOVA|||||||0.519
73942373|NCT03786952|147416722|SUPERIORITY|||||||0.007|||||||ANOVA|||||||0.007
73942374|NCT03786952|147416723|SUPERIORITY|||||||0.457|||||||ANOVA|||||||0.457
73942375|NCT03786952|147416724|SUPERIORITY|||||||0.415|||||||ANOVA|||||||0.415
74039443|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.0959|TWO_SIDED|95.0|-0.39|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.03|-0.39|0.0959
73942376|NCT03786952|147416725|SUPERIORITY|||||||0.923|||||||ANOVA|||||||0.923
73942377|NCT03786952|147416726|SUPERIORITY|||||||0.981|||||||ANOVA|||||||0.981
73942378|NCT03786952|147416727|SUPERIORITY|||||||0.627|||||||ANOVA|||||||0.627
73942379|NCT03786952|147416728|SUPERIORITY|||||||0.901|||||||ANOVA|||||||0.901
73942380|NCT03786952|147416729|SUPERIORITY|||||||0.166|||||||ANOVA|||||||0.166
73942381|NCT03786952|147416730|SUPERIORITY|||||||0.252|||||||ANOVA|||||||0.252
73942382|NCT02152982|147416739|SUPERIORITY|||||||0.1462|||||||Log Rank|||||||0.1462
73942383|NCT02152982|147416740|SUPERIORITY||Cox Proportional Hazard|1.02||||0.9101|TWO_SIDED|95.0|0.7|1.5|||Type 3 likelihood-ratio p-value|||||1.50|0.70|0.9101
73942384|NCT02152982|147416741|SUPERIORITY||Cox Proportional Hazard|1.05||||0.3059|TWO_SIDED|95.0|0.86|1.29|||Log Rank|||||1.29|0.86|0.3059
73942385|NCT02152982|147416742|SUPERIORITY|||||||0.6827|||||||Chi-squared|||||||0.6827
73942386|NCT02152982|147416743|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73942387|NCT02684006|147416747|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.0001|TWO_SIDED|95.0|0.475|0.79||2-sided p-value|Log Rank|||||0.790|0.475|0.0001
73942388|NCT02684006|147416748|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1509|TWO_SIDED|95.0|0.701|1.057||2-sided p-value|Log Rank|||||1.057|0.701|0.1509
73942389|NCT02684006|147416749|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0002|TWO_SIDED|95.0|0.563|0.84||2-sided p-value|Log Rank|||||0.840|0.563|0.0002
73942390|NCT02684006|147416750|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1338|TWO_SIDED|95.0|0.749|1.039||2-sided p-value|Log Rank|||||1.039|0.749|0.1338
73942391|NCT02684006|147416759|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.565|0.768||2-sided p-value|Log Rank|||||0.768|0.565|<.0001
73942392|NCT02684006|147416760|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.551|0.754||||||||0.754|0.551|
73942393|NCT00715429|147416833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27||||||Daily cramp rate at baseline\& on treatment, were calculated as % of each subjects total # of cramps, for comparison among subjects. Change in % cramp rates from baseline to treatment was computed for each subject in vit D and placebo groups.|t-test, 2 sided|T test was used to compare the change in % cramp rate from baseline to treatment for each subject in each treatment group.||||||0.27
73942394|NCT04085328|147416837|NON_INFERIORITY|Predefined margin of 0.05 for noninferiority|Difference in proportion|-0.0154|||||ONE_SIDED|95.0||-0.0015|||Generalized linear model|Proportion of events was analyzed using a generalized linear model, with a logit link function, accounting for within-subject correlation.|Difference in proportion = LID015385 minus Biofinity.|||-0.0015||
73942395|NCT00514735|147416838|SUPERIORITY_OR_OTHER||||||<|0.0001||||||In order to maintain the overall level of significance at the α=0.025 level after a planned interim analysis using α=0.003, this test will actually be performed using an adjusted α=0.0245 at the completion of the study.|Chi-squared|||"H0: Pa ≤ Pm Ha: Pa \> Pm~where Pa is the proportion of successfully treated subjects in the ablation management arm and Pm is the proportion of successfully treated subjects in the optimal medical management/drug therapy arm."||||<0.0001
73942396|NCT00514735|147416839|SUPERIORITY_OR_OTHER|||||||0.1427||||||An exact, one-sample binomial test was conducted at a one-sided α=0.025 level of significance.|Fisher Exact|||"H0: Pa ≥ 0.16 Ha: Pa \< 0.16~where Pa is the proportion of acute safety failures in the ablation management arm."||||0.1427
73942397|NCT00514735|147416840|NON_INFERIORITY_OR_EQUIVALENCE|This objective was not statistically powered. The non-inferiority chronic safety margin was 0.06.||||||0.0033|||||||t-test, 1 sided|||"H0: Pa ≥ Pm + 0.06 Ha: Pa \< Pm + 0.06~where Pa is the proportion of failed subjects in the ablation management arm and Pm is the proportion of failed subjects in the optimal medical management/drug therapy arm."||||0.0033
73942398|NCT00514735|147416842|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LAD from baseline to 6 month in Ablation Management arm, and μm is the change of LAD from baseline to 6 month in Medical Management arm."||||0.35
73868811|NCT02391363|147282514|SUPERIORITY|||||||0.42||||||Parameter estimate for treatment group = 0.42 (SE = 0.51). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.42
73942399|NCT00514735|147416843|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LVEF from baseline to 6 month in Ablation Management arm, and μm is the change of LVEF from baseline to 6 month in Medical Management arm."||||0.06
73942400|NCT00514735|147416844|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73942401|NCT00514735|147416845|SUPERIORITY_OR_OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||<0.025
73942402|NCT05417620|147416846|OTHER||Incidence rate ratio|1.21||||0.707|TWO_SIDED|95.0|0.44|3.31||Threshold for significance: 0.05.|Regression, Poisson|||"This statistical analysis is done at the district level where counts of initiations in intervention districts are compared to standard of care districts. In the measure type we report rate = average counts of PrEP initiations per number of study months."||3.31|0.44|0.707
73942403|NCT04274894|147416866|NON_INFERIORITY|"The hypothesis for the primary safety analysis is:~H0: Change in 24-hour average SBP from Baseline to EOT ≥ 3 mmHg Vs. H1: Change in 24-hour average SBP from Baseline to EOT \< 3 mmHg"|LS Mean Change from Baseline to EOT|1.9|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|0.63|3.13||||||The primary endpoint of change from Baseline to End of Treatment (EOT) in average 24-hour SBP was evaluated using a linear regression model with change in average 24-hour SBP from Baseline to EOT as the dependent variable, centralized baseline average 24-hour SBP, ongoing medical history of hypertension, and pooled study center as covariates in the per protocol population.||3.13|0.63|
73868812|NCT02391363|147282515|SUPERIORITY|||||||0.85||||||Parameter estimate for treatment group = 0.09 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.85
73942404|NCT02279043|147416872|SUPERIORITY||Odds Ratio (OR)|0.88||||0.89|TWO_SIDED|95.0|0.16|4.88|||Regression, Logistic|||||4.88|0.16|0.89
73942405|NCT02279043|147416873|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
73942406|NCT02279043|147416874|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
73942407|NCT02279043|147416874|SUPERIORITY||Slope|0.59||||0.02|TWO_SIDED|95.0|0.08|1.11|||Regression, Linear|||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||1.11|0.08|0.02
73942408|NCT02279043|147416875|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
73942409|NCT02279043|147416876|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
73942410|NCT02279043|147416877|SUPERIORITY||Odds Ratio (OR)|1.29||||0.34|TWO_SIDED|95.0|0.75|2.2|||Regression, Logistic|||||2.20|0.75|0.34
73942411|NCT02279043|147416878|SUPERIORITY||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.49|2.05|||Regression, Logistic|||||2.05|0.49|0.99
73942412|NCT02279043|147416879|SUPERIORITY||Odds Ratio (OR)|1.48||||0.08|TWO_SIDED|95.0|0.95|2.29|||Regression, Logistic|||||2.29|0.95|0.08
73974919|NCT03983434|147495714|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.98|||||||Kruskal-Wallis|||||||0.98
73942413|NCT02279043|147416880|SUPERIORITY||Odds Ratio (OR)|1.63||||0.03|TWO_SIDED|95.0|1.05|2.58|||Regression, Logistic|||||2.58|1.05|0.03
73942414|NCT02279043|147416880|SUPERIORITY||Slope|0.5||||0.03|TWO_SIDED|95.0|0.04|0.97|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||0.97|0.04|0.03
73942415|NCT02279043|147416881|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.01|TWO_SIDED|95.0|1.42|3.56|||Regression, Logistic|||||3.56|1.42|<0.01
73942416|NCT02279043|147416881|SUPERIORITY||Slope|0.84|||<|0.01|TWO_SIDED|95.0|0.33|1.35|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||1.35|0.33|<0.01
73942417|NCT02279043|147416882|SUPERIORITY||Odds Ratio (OR)|1.02||||0.93|TWO_SIDED|95.0|0.52|2.74|||Regression, Logistic|||||2.74|0.52|0.93
73942418|NCT02279043|147416883|SUPERIORITY||Odds Ratio (OR)|1.19||||0.68|TWO_SIDED|95.0|0.52|2.74|||Regression, Logistic|||||2.74|0.52|0.68
73942419|NCT02279043|147416884|SUPERIORITY||Odds Ratio (OR)|1.24||||0.33|TWO_SIDED|95.0|0.08|1.93|||Regression, Logistic|||||1.93|0.08|0.33
73942420|NCT01077830|147416916|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.84|2.09|||Regression, Cox||Hazard Ratio obtained by dividing the crude rate of death (any cause) reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death (any cause) in the Placebo arm|||2.09|0.84|
73974920|NCT01324310|147495755|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric Mean|124.4|||||TWO_SIDED|90.0|110.2|140.5|||ANOVA||"Geometric means ratio (Romidepsin + Ketoconazole/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||140.5|110.2|
73974921|NCT01324310|147495756|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|123.7|||||TWO_SIDED|90.0|109.6|139.6|||ANOVA|||||139.6|109.6|
73942421|NCT01077830|147416917|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.3|6.06|||||Hazard Ratio obtained by dividing the crude rate of death from cancer reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death from cancer in the Placebo arm|||6.06|0.30|
73942422|NCT01077830|147416918|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.27|1.11|||||Hazard Ratio obtained by dividing the crude rate of new cancers reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of newly diagnosed cancers in the the Placebo arm|||1.11|0.27|
73942423|NCT01194570|147416921|SUPERIORITY_OR_OTHER_LEGACY||Relative Reduction (%)|29.337||||0.0404|TWO_SIDED|95.0|-1.618|51.456||P-value from a ranked ANCOVA on Percent Change from BL adjusting for rank of BL 25-Foot Timed Walk (25-FTW), Geographical Region (US vs ROW) and Age (\<=45, \> 45 years); missing observations imputed with LOCF.|Ranked ANCOVA||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates (back-transformed) based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-baseline(BL)/BL) = log(BL 25-FTW) + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + log (BL 25-FTW)\*Week. Relative reduction was calculated as -Relative change = -(OCR response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.||51.456|-1.618|0.0404
73942424|NCT01194570|147416922|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Geometric Means|0.9|||<|0.0001|TWO_SIDED|95.0|0.876|0.924||P-value is from ranked ANCOVA on Percent Change from BL adjusting for rank of BL T2 lesion volume, Geographical Region (US vs ROW) and Age (\<=45, \> 45 years); missing observations imputed with LOCF.|Ranked ANCOVA|||Estimates (back-transformed) are based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-BL/BL) = log(BL T2 lesion volume) + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + log (BL T2 lesion volume)\*Week.||0.924|0.876|< 0.0001
73942425|NCT01194570|147416923|SUPERIORITY_OR_OTHER_LEGACY||Relative Reduction (%)|17.475||||0.0206|TWO_SIDED|95.0|3.206|29.251|||MMRM||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + Brain Volume at Week 24\*Week. Relative reduction was calculated as - Relative change = - (OCR response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using Bootstrap method.||29.251|3.206|0.0206
73942426|NCT01194570|147416924|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.377|STANDARD_ERROR_OF_MEAN|0.725||0.6034|TWO_SIDED|95.0|-1.048|1.802|||MMRM||Difference in adjusted mean was calculated as Ocrelizumab SF-36 Physical Component Summary Score - Placebo SF-36 Physical Component Summary Score.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Change = Baseline PCS Score + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + Baseline PCS Score\*Week.||1.802|-1.048|0.6034
73942427|NCT00789815|147416957|NON_INFERIORITY_OR_EQUIVALENCE|A preliminary study was performed to determine the sample size before this trial. 15 and 15 patients undergoing FB received BIS-guided propofol sedation and clinical-judged midazolam sedation, respectively. The incidences of hypoxemia were 0.33 and 0.20, respectively. The selected sample size of 225 in each group will yield 90% power for detecting a clinically meaningful difference of 0.13 at the 5.0% level of significance. To allow for 10% missing data, we recruited 250 patients per group.||||||0.05||95.0|||||Chi-squared|||"The null hypothesis: the incidence of hypoxemia occured during FB with BIS-guided propofol infusion is higher than that with clinical-judged midazolam administration.~Power calculation is described below."||||0.05
73942428|NCT00789815|147416958|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||The null hypothesis: the incidence of hypotension during FB in patients of study group is higher than that in the control group.||||0.05
73942429|NCT00789815|147416959|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
73942430|NCT00789815|147416960|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
73942431|NCT00789815|147416961|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
73942432|NCT00789815|147416962|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the global tolerance of patients in study is worse than that in the control group.||||0.05
73942433|NCT00789815|147416963|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
73942434|NCT00789815|147416964|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
73942435|NCT00662857|147416968|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.982|||||TWO_SIDED|90.0|0.846|1.141|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||1.141|0.846|
73942436|NCT00662857|147416969|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.951|||||TWO_SIDED|90.0|0.823|1.099|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||1.099|0.823|
73942437|NCT00662857|147416970|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3531|||||||Signed Rank Test|||||||0.3531
74089214|NCT01045993|147731457|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.600
74089215|NCT01045993|147731457|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.294
74089216|NCT01045993|147731458|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.088
73868813|NCT02391363|147282516|SUPERIORITY|||||||0.55||||||Parameter estimate for treatment group = -0.28 (SE = 0.46). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.55
73868814|NCT02391363|147282517|SUPERIORITY|||||||0.54||||||Parameter estimate for treatment group = -0.29 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.54
73942438|NCT00662857|147416971|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.46|||||TWO_SIDED|90.0|0.366|0.578|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge of TI to 10 U sc insulin lispro.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||0.578|0.366|
73942439|NCT03675451|147416973|OTHER|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Proportion of Participants|0.95|||||TWO_SIDED|95.0|0.74|0.99|||||Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.||0.99|0.74|
73942440|NCT03675451|147416974|OTHER|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Proportion of Participants|1.0|||||TWO_SIDED|95.0|0.66|1.0|||||Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.||1.00|0.66|
73942441|NCT00514943|147416993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||0.7606|TWO_SIDED|95.0|-11.188|8.202||P-value obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions.|ANCOVA|Receipt of prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance for target lesions are covariates|Mean difference calculated is actually the adjusted mean difference.|||8.202|-11.188|0.7606
73942442|NCT00514943|147417006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.764|TWO_SIDED|95.0|0.64|1.387|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.387|0.640|0.764
73942443|NCT00514943|147417007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725||||0.219|TWO_SIDED|95.0|0.434|1.212|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.212|0.434|0.219
73942444|NCT00514943|147417008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.067||||0.758|TWO_SIDED|95.0|0.708|1.608|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.608|0.708|0.758
73974922|NCT01324310|147495757|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|124.6|||||TWO_SIDED|90.0|109.0|142.4|||ANOVA|||||142.4|109.0|
73942445|NCT01783418|147417058|SUPERIORITY_OR_OTHER|||||||0.613|TWO_SIDED||||||ANOVA|||Baseline and Post-intervention (8 weeks)||||0.613
73942446|NCT01783418|147417059|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.957
73942447|NCT01783418|147417060|SUPERIORITY_OR_OTHER|||||||0.256|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||.256
73942448|NCT01783418|147417061|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.97
73942449|NCT01783418|147417062|SUPERIORITY_OR_OTHER|||||||0.241|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention||||0.241
73942450|NCT01783418|147417063|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.358
73942451|NCT01783418|147417064|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.95
73974923|NCT01324310|147495758|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|109.5|||||TWO_SIDED|90.0|94.9|126.4|||ANOVA|||||126.4|94.9|
73974924|NCT01324310|147495759|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.7422|TWO_SIDED|90.0|-0.485|0.095|||Wilcoxon signed- rank|||"Note: The median, median difference (romidepsin + ketoconazole minus romidepsin) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test."||0.095|-0.485|0.7422
73974925|NCT03170882|147495768|SUPERIORITY||Hazard Ratio (HR)|0.847|||=|0.477|TWO_SIDED|95.0|0.535|1.341|||Log Rank||HR obtained by unadjusted Cox's proportional hazard regression model stratified by age,international staging system(ISS),prior lines of therapy. HR\<1 was deemed to indicate better PFS in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.341|0.535|=0.477
73974926|NCT03170882|147495769|SUPERIORITY||Hazard Ratio (HR)|1.427|||=|0.265|TWO_SIDED|95.0|0.761|2.677|||Log Rank||HR obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS and prior lines of therapy. HR \<1 was deemed to indicate longer survival time in Ixazomib + Dexamethasone arm as compared to Pomalidomide + Dexamethasone arm.|||2.677|0.761|=0.265
74031336|NCT00418262|147616147|SUPERIORITY||Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||1.38|-0.69|
73942452|NCT02563002|147417191|OTHER||Hazard Ratio (HR)|0.59||||0.0001|TWO_SIDED|95.0|0.45|0.79|||Log Rank|One-sided p-value based on log rank test|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||0.79|0.45|0.0001
73942453|NCT02563002|147417192|OTHER||Hazard Ratio (HR)|0.74||||0.0359|TWO_SIDED|95.0|0.53|1.03|||Log Rank|One-sided p-value based on log rank test|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.03|0.53|0.0359
73942454|NCT02563002|147417193|OTHER||Difference in percentage|12.0||||0.0159|TWO_SIDED|95.0|1.0|22.6||One-sided p-value based on Miettinen \& Nurminen method.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method.|||22.6|1.0|0.0159
73942455|NCT03466086|147417196|SUPERIORITY|This was a pilot study and the sample size was not based on any empirical power calculation.|Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|1.238|||TWO_SIDED|95.0|-2.35|2.59||Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is greater than 0.|Multivariate Bayesian Model|The correlation between measurements across periods were modeled using unstructured variance-covariance matrix.|Mean Difference was calculated as Test minus Control.|||2.59|-2.35|
73942456|NCT03466086|147417197|SUPERIORITY|Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is less than 0.|Mean Difference (Final Values)|1.49|STANDARD_DEVIATION|0.951|||TWO_SIDED|95.0|-0.4|3.37|||Multivariate Bayesian Analysis|The correlation between measurements across periods were modeled using unstructured variance-covariance matrix.||This was a pilot study and the sample size was not based on any empirical power calculation.|Mean difference was calculated as Test - Control|3.37|-0.40|
73942457|NCT00677352|147417202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sertraline was concluded to be non-inferior to paroxetine when the upper limit of the CI fell below the non-inferiority margin of 4.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.5|1.6|||ANCOVA|||The two-sided 95% confidence interval (CI) of the intergroup difference (sertraline group - paroxetine group) of the mean reduction in the PAS total score at each dose during the treatment phase was calculated using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline PAS total score as a covariate.||1.6|-2.5|
73942458|NCT00677352|147417208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05 (two-sided).|Fisher Exact|||||||0.0062
73942459|NCT02182973|147417209|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73942460|NCT02182973|147417210|SUPERIORITY|||||||0.875|||||||t-test, 2 sided|||||||0.875
73942461|NCT02182973|147417211|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||||||0.025
74039444|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.037|TWO_SIDED|95.0|-0.44|-0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.01|-0.44|0.0370
73942462|NCT01123382|147417212|SUPERIORITY_OR_OTHER|||||||0.04||||||Group X time interaction|Mixed Models Analysis|we included a random intercept for each individual participant. We used a first-order antedependent covariance structure.||To detect a minimum clinically important difference of 2 points2 on the BPI-SF3 with an anticipated standard deviation for each mean of 2.5, estimated from a prior study, with an alpha level of 0.05 and a power of 80%, for five waves of data, a sample size of 10 participants per group was necessary. With anticipated dropouts, a sample size of at least 12 participants per group was required.||||0.04
73942463|NCT01123382|147417213|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED|||||group x time interaction 0.059|Mixed Models Analysis|||||||0.059
73942464|NCT01123382|147417214|SUPERIORITY_OR_OTHER|||||||0.543||||||group x time interaction 0.543|Mixed Models Analysis|||||||0.543
73942465|NCT01123382|147417215|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||group x time interaction 0.33|Mixed Models Analysis|||||||0.33
73942466|NCT01123382|147417216|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||group x time 0.61|Mixed Models Analysis|||||||0.61
73942467|NCT01123382|147417217|SUPERIORITY_OR_OTHER|||||||0.398||||||group x time interaction 0.398|Mixed Models Analysis|||||||0.398
73942468|NCT01123382|147417218|SUPERIORITY_OR_OTHER|||||||0.46||||||group x time interaction 0.46|Mixed Models Analysis|||||||0.46
73942469|NCT01123382|147417219|SUPERIORITY_OR_OTHER|||||||0.59||||||group x time interaction 0.59|Mixed Models Analysis|||||||0.59
73942470|NCT01123382|147417220|SUPERIORITY_OR_OTHER|||||||0.69||||||group x time interaction 0.69|Mixed Models Analysis|||||||0.69
73942471|NCT00762450|147417227|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|paired t-tests||The null hypothesis states that there is no difference between groups.||||0.05
73942472|NCT03905330|147417228|SUPERIORITY||Least-Square mean|-1.089|STANDARD_ERROR_OF_MEAN|0.3691|=|0.0063|TWO_SIDED|95.0|-1.845|-0.334|||Mixed Models Analysis|||The difference between maralixibat and placebo treatment groups in the mean change in the average ItchRO(Obs) severity score between baseline and Weeks 15-26||-0.334|-1.845|= 0.0063
73942473|NCT03905330|147417229|SUPERIORITY||Least-Square mean|-186.723|STANDARD_ERROR_OF_MEAN|51.9501|=|0.0013|TWO_SIDED|95.0|-293.454|-79.992|||Mixed Models Analysis|||||-79.992|-293.454|= 0.0013
73942474|NCT03905330|147417230|SUPERIORITY||Least-Square mean|-1.2|STANDARD_ERROR_OF_MEAN|0.263|<|0.0001|TWO_SIDED|95.0|-1.727|-0.674|||Mixed Models Analysis|||||-0.674|-1.727|< 0.0001
73942475|NCT03905330|147417231|SUPERIORITY||Least-Square mean|-160.403|STANDARD_ERROR_OF_MEAN|30.1827|<|0.0001|TWO_SIDED|95.0|-220.836|-99.97|||Mixed Models Analysis|||||-99.970|-220.836|< 0.0001
73942476|NCT03905330|147417232|OTHER||||||=|0.0736|||||||Bernard's exact test|||||||= 0.0736
73942477|NCT03905330|147417233|SUPERIORITY||||||=|0.041|||||||Bernard's exact test|||||||= 0.0410
73868815|NCT00265317|147282526|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.3206|TWO_SIDED|80.0|0.575|1.404||Primary analysis was based on an unstratified 1-sided log rank test with alpha=0.1|Log Rank|||Sample size for randomized portion of study determined based on these assumptions: median PFS (erlotinib)=10 weeks, accrual time=12 months. With 6 months follow-up, study was powered to detect a difference in PFS of 5 weeks. 1-sided log rank test comparing the 2 treatment groups with 115 events of PD or death among a target sample size of 126 participants (63 per group) achieved 80% power at a 10% significance level to detect a 50% improvement in PFS from 10 to 15 weeks.||1.404|0.575|0.3206
73868816|NCT00265317|147282527|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.546||||0.6251|TWO_SIDED|95.0|0.267|8.954|||Cochran-Mantel-Haenszel|||95% confidence interval (CI) calculated based on f-distribution||8.954|0.267|0.6251
73868817|NCT00265317|147282528|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921||||0.3732|TWO_SIDED|95.0|0.572|1.485||1-sided unstratified log-rank test|Log Rank|||||1.485|0.572|0.3732
73868818|NCT00265317|147282530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.066||||0.6171|TWO_SIDED|95.0|0.705|1.612||p-value from 1-sided unstratified log-rank test|Log Rank|||||1.612|0.705|0.6171
74089217|NCT01045993|147731458|SUPERIORITY_OR_OTHER|||||||0.625||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.625
74089218|NCT01045993|147731458|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.034
74089219|NCT01045993|147731459|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Cochran-Mantel-Haenszel|P-value from the Cochran-Mantel-Haenszel test with modified ridit scores.||||||<0.001
73868819|NCT00265317|147282531|SUPERIORITY_OR_OTHER||Percentage|32.0|||||TWO_SIDED|95.0|19.7|44.3||||||Percentage of participants surviving at 1 year in the Sunitinib + Erlotinib Treatment Group, estimated using the Kaplan-Meier method||44.3|19.7|
73942478|NCT03905330|147417234|SUPERIORITY||||||=|0.0023|||||||Bernard's exact test|||||||= 0.0023
73942479|NCT03905330|147417235|SUPERIORITY||||||=|0.0004|||||||Bernard's exact test|||||||= 0.0004
73942480|NCT02782169|147417236|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.32
73942481|NCT03848403|147417268|SUPERIORITY||Least Squares (LS) Means Difference|-21.69|||<|0.0001|TWO_SIDED|95.0|-26.9|-16.48|||Mixed Models Analysis|||||-16.48|-26.90|<0.0001
73868820|NCT00265317|147282531|SUPERIORITY_OR_OTHER||Percentage|42.0|||||TWO_SIDED|95.0|30.1|54.2||||||Percentage of participants surviving at 1 year in the Erlotinib + Placebo Treatment Group, estimated using the Kaplan-Meier method||54.2|30.1|
73868821|NCT00265317|147282559|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.748||||0.2247|TWO_SIDED|95.0|0.351|1.591|||Log Rank|||Positive EGFR Expression||1.591|0.351|0.2247
73974927|NCT03170882|147495770|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.634|TWO_SIDED|95.0|0.43|1.9|||Cochran-Mantel-Haenszel||OR was based on logistic regression model with treatment group as categorical predictor variable and age, ISS and prior lines of therapy. OR \>1 was deemed to indicate better response in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.90|0.43|=0.634
73868822|NCT00265317|147282559|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.184||||0.6797|TWO_SIDED|95.0|0.581|2.414|||Log Rank|||Negative EGFR Expression||2.414|0.581|0.6797
73868823|NCT00265317|147282559|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.632||||0.1693|TWO_SIDED|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression||1.627|0.245|0.1693
73868824|NCT00265317|147282561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.3223|TWO_SIDED|95.0|0.458|1.628|||Log Rank|||Positive EGFR Expression||1.628|0.458|0.3223
73868825|NCT00265317|147282561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.946||||0.4608|TWO_SIDED|95.0|0.362|2.474|||Log Rank|||Negative EGFR Expression||2.474|0.362|0.4608
73942482|NCT03848403|147417268|SUPERIORITY||LS Means Difference|-21.14|||<|0.0001|TWO_SIDED|95.0|-26.39|-15.88|||Mixed Models Analysis|||||-15.88|-26.39|<0.0001
73942483|NCT03848403|147417268|SUPERIORITY||LS Means Difference|0.55||||0.8341|TWO_SIDED|95.0|-4.65|5.75|||Mixed Models Analysis|||||5.75|-4.65|0.8341
73942484|NCT01939548|147417270|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|3.11|STANDARD_ERROR_OF_MEAN|2.409||0.1991|TWO_SIDED|80.0|0.01|6.21||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.||6.21|0.01|0.1991
73974928|NCT03170882|147495772|SUPERIORITY||Hazard Ratio (HR)|0.556|||||TWO_SIDED|95.0|0.288|1.073|||||HR was obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS, prior lines of therapy. HR \>1 was deemed to indicate quicker response time in Ixazomib + Dexamethasone arm over Pomalidomide + Dexamethasone arm.|||1.073|0.288|
73974929|NCT03170882|147495773|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.459|TWO_SIDED|95.0|0.506|1.361|||Log Rank||HR: obtained by unadjusted Cox's proportional hazard regression model stratified by age,ISS,prior lines of therapy. HR\<1 was deemed to indicate better disease progression prevention in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.361|0.506|=0.459
73974930|NCT04027439|147495784|OTHER||Contrast Ratio|1.186|||<|0.0001|TWO_SIDED|95.0|1.138|1.235|||ANCOVA|||||1.235|1.138|<0.0001
73974931|NCT04027439|147495784|OTHER||Contrast Ratio|1.134|||<|0.0001|TWO_SIDED|95.0|1.088|1.181|||ANCOVA|||||1.181|1.088|<0.0001
73974932|NCT04027439|147495784|OTHER||Contrast Ratio|1.134|||<|0.0001|TWO_SIDED|95.0|1.089|1.181|||ANCOVA|||||1.181|1.089|<0.0001
73974933|NCT04027439|147495784|OTHER||Contrast Ratio|1.084||||0.0001|TWO_SIDED|95.0|1.041|1.128|||ANCOVA|||||1.128|1.041|0.0001
73974934|NCT04027439|147495785|OTHER||Contrast Ratio|1.228||||0.0004|TWO_SIDED|95.0|1.105|1.365|||ANCOVA|||||1.365|1.105|0.0004
73974935|NCT04027439|147495785|OTHER||Contrast Ratio|1.228||||0.0004|TWO_SIDED|95.0|1.104|1.365|||ANCOVA|||||1.365|1.104|0.0004
73974936|NCT04027439|147495785|OTHER||Contrast Ratio|1.196||||0.0012|TWO_SIDED|95.0|1.08|1.326|||ANCOVA|||||1.326|1.080|0.0012
73942485|NCT01939548|147417270|SUPERIORITY_OR_OTHER||LSM Difference|2.3|STANDARD_ERROR_OF_MEAN|2.445||0.3488|TWO_SIDED|80.0|-0.85|5.45||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.||5.45|-0.85|0.3488
73942486|NCT01939548|147417271|SUPERIORITY_OR_OTHER||LSM Difference|-0.23|STANDARD_ERROR_OF_MEAN|1.476||0.8786|TWO_SIDED|80.0|-2.13|1.67||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.67|-2.13|0.8786
73868826|NCT00265317|147282561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.632||||0.1693|TWO_SIDED|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression||1.627|0.245|0.1693
73868827|NCT00265317|147282563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.049||||0.5526|TWO_SIDED|95.0|0.542|2.031|||Log Rank|||No EGFR Gene Copy Number Increase||2.031|0.542|0.5526
73868828|NCT00265317|147282563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.1529|TWO_SIDED|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Copy Number Increase||1.344|0.380|0.1529
73868829|NCT00265317|147282565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078||||0.5839|TWO_SIDED|95.0|0.557|2.085|||Log Rank|||No EGFR Gene Amplification||2.085|0.557|0.5839
73868830|NCT00265317|147282565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.1529|TWO_SIDED|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Amplification||1.344|0.380|0.1529
73974937|NCT04027439|147495785|OTHER||Contrast Ratio|1.121||||0.0348|TWO_SIDED|95.0|1.009|1.246|||ANCOVA|||||1.246|1.009|0.0348
73974938|NCT04027439|147495785|OTHER||Contrast Ratio|1.055||||0.3106|TWO_SIDED|95.0|0.949|1.172|||ANCOVA|||||1.172|0.949|0.3106
74089220|NCT01659736|147731461|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||p-value is for the condition (active TMS versus Sham) by time (pre, post, 3-month follow-up) interaction|ANOVA|||||||0.006
74089221|NCT00391079|147731466|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.17||||0.468|TWO_SIDED|95.0|-0.62|0.29|||ANCOVA|||The change in pain NRS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||0.29|-0.62|0.468
73868831|NCT00265317|147282567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.6324|TWO_SIDED|95.0|0.516|2.608|||Log Rank|||Wild Type EGFR Gene Mutation||2.608|0.516|0.6324
73868832|NCT00265317|147282567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.813||||0.2413|TWO_SIDED|95.0|0.464|1.424|||Log Rank|||Indeterminate EGFR Gene Mutation||1.424|0.464|0.2413
73868833|NCT00265317|147282569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.481||||0.2077|TWO_SIDED|95.0|0.079|2.91|||Log Rank|||Mutated KRAS Gene Mutation||2.910|0.079|0.2077
73868834|NCT00265317|147282569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.6439|TWO_SIDED|95.0|0.534|2.531|||Log Rank|||Wild Type KRAS Gene Mutation||2.531|0.534|0.6439
73868835|NCT00265317|147282569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.2664|TWO_SIDED|95.0|0.457|1.489|||Log Rank|||Indeterminate KRAS Gene Mutation||1.489|0.457|0.2664
73868836|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.7423|TWO_SIDED|95.0|0.541|2.36||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C||2.360|0.541|0.7423
73868837|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.598||||0.157|TWO_SIDED|95.0|0.29|1.236||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T||1.236|0.290|0.1570
73868838|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.7954|TWO_SIDED|95.0|0.131|4.819||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T||4.819|0.131|0.7954
73868839|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.833||||0.621|TWO_SIDED|95.0|0.401|1.732||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/G||1.732|0.401|0.6210
73868840|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.5268|TWO_SIDED|95.0|0.385|1.64||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/T||1.640|0.385|0.5268
73868841|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.011||||0.9753|TWO_SIDED|95.0|0.504|2.027||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/T||2.027|0.504|0.9753
73868842|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.378||||0.0141|TWO_SIDED|95.0|0.168|0.85||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A||0.850|0.168|0.0141
73868843|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.236||||0.5596|TWO_SIDED|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A||35.90|0.139|0.5596
73868844|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738||||0.2788|TWO_SIDED|95.0|0.422|1.288||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C||1.288|0.422|0.2788
73868845|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.8971|TWO_SIDED|95.0|0.352|3.286||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T||3.286|0.352|0.8971
73868846|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.775||||0.6559|TWO_SIDED|95.0|0.251|2.388||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C||2.388|0.251|0.6559
73868847|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.939||||0.8563|TWO_SIDED|95.0|0.466|1.889||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T||1.889|0.466|0.8563
73868848|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.382||||0.668|TWO_SIDED|95.0|0.13|1.12||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T||1.120|0.130|0.668
73868849|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3681|TWO_SIDED|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs35636987 Genotype: C/C||1.309|0.488|0.3681
73868850|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.752|TWO_SIDED|95.0|0.331|2.237||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C||2.237|0.331|0.7520
73868851|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.551||||0.0833|TWO_SIDED|95.0|0.276|1.098||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T||1.098|0.276|0.0833
73868852|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.4772|TWO_SIDED|95.0|0.444|5.506||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T||5.506|0.444|0.4772
73868853|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.034||||0.9235|TWO_SIDED|95.0|0.522|2.048||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G||2.048|0.522|0.9235
73868854|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.501||||0.0845|TWO_SIDED|95.0|0.223|1.126||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A||1.126|0.223|0.0845
73868855|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.724||||0.5493|TWO_SIDED|95.0|0.284|10.47||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A||10.47|0.284|0.5493
73868856|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.521|TWO_SIDED|95.0|0.492|3.987||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G||3.987|0.492|0.5210
73868857|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.538||||0.0854|TWO_SIDED|95.0|0.261|1.108||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A||1.108|0.261|0.0854
73868858|NCT00265317|147282571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.9198|TWO_SIDED|95.0|0.365|2.489||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A||2.489|0.365|0.9198
73868859|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977||||0.9486|TWO_SIDED|95.0|0.473|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C||2.014|0.473|0.9486
73868860|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.961||||0.9084|TWO_SIDED|95.0|0.487|1.897||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T||1.897|0.487|0.9084
73868861|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.876||||0.2009|TWO_SIDED|95.0|0.534|15.48||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T||15.48|0.534|0.2009
73868862|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.098||||0.7863|TWO_SIDED|95.0|0.554|2.175||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305845 Genotype: G/G||2.175|0.554|0.7863
73868863|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.243||||0.5267|TWO_SIDED|95.0|0.633|2.442||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR2/rs2305945 Genotype: G/T||2.442|0.633|0.5267
73868864|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.624|TWO_SIDED|95.0|0.049|6.208||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: T/T||6.208|0.049|0.6240
73868865|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.254||||0.4882|TWO_SIDED|95.0|0.66|2.384||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR/rs1870377 Genotype: T/T||2.384|0.660|0.4882
73868866|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.587||||0.1307|TWO_SIDED|95.0|0.29|1.189||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A||1.189|0.290|0.1307
73868867|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.236||||0.5596|TWO_SIDED|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A||35.90|0.139|0.5596
73868868|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.7966|TWO_SIDED|95.0|0.628|1.833||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C||1.833|0.628|0.7966
73868869|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.954||||0.9224|TWO_SIDED|95.0|0.366|2.484||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T||2.484|0.366|0.9224
73868870|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047||||0.9317|TWO_SIDED|95.0|0.363|3.025||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C||3.025|0.363|0.9317
73868871|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.8696|TWO_SIDED|95.0|0.546|2.044||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T||2.044|0.546|0.8696
73868872|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.8694|TWO_SIDED|95.0|0.453|2.554||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T||2.554|0.453|0.8694
73868873|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8708|TWO_SIDED|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs3563987 Genotype: C/C||1.652|0.654|0.8708
73868874|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.157||||0.7667|TWO_SIDED|95.0|0.442|3.026||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C||3.026|0.442|0.7667
73868875|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.3822|TWO_SIDED|95.0|0.401|1.422||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T||1.422|0.401|0.3822
73868876|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.419||||0.5089|TWO_SIDED|95.0|0.498|4.04||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T||4.040|0.498|0.5089
73868877|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.326||||0.3944|TWO_SIDED|95.0|0.691|2.544||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G||2.544|0.691|0.3944
73868878|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.3103|TWO_SIDED|95.0|0.339|1.416||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A||1.416|0.339|0.3103
73868879|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.857||||0.8942|TWO_SIDED|95.0|0.089|8.294||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A||8.294|0.089|0.8942
73868880|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.665|TWO_SIDED|95.0|0.466|3.304||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G||3.304|0.466|0.6650
73974939|NCT04027439|147495786|OTHER||Contrast Ratio|1.154||||0.0208|TWO_SIDED|95.0|1.024|1.301|||ANCOVA|||||1.301|1.024|0.0208
73942487|NCT01939548|147417271|SUPERIORITY_OR_OTHER||LSM Difference|-1.14|STANDARD_ERROR_OF_MEAN|1.502||0.4483|TWO_SIDED|80.0|-3.08|0.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.79|-3.08|0.4483
73942488|NCT01939548|147417272|SUPERIORITY_OR_OTHER||LSM Difference|0.81|STANDARD_ERROR_OF_MEAN|0.809||0.3201|TWO_SIDED|80.0|-0.23|1.85||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.85|-0.23|0.3201
73942489|NCT01939548|147417272|SUPERIORITY_OR_OTHER||LSM Difference|0.85|STANDARD_ERROR_OF_MEAN|0.813||0.2961|TWO_SIDED|80.0|-0.19|1.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.90|-0.19|0.2961
73942490|NCT01939548|147417272|SUPERIORITY_OR_OTHER||LSM Difference|0.39|STANDARD_ERROR_OF_MEAN|0.743||0.6015|TWO_SIDED|80.0|-0.57|1.35||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.35|-0.57|0.6015
73942491|NCT01939548|147417272|SUPERIORITY_OR_OTHER||LSM Difference|0.21|STANDARD_ERROR_OF_MEAN|0.761||0.7787|TWO_SIDED|80.0|-0.77|1.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.19|-0.77|0.7787
73942492|NCT01939548|147417272|SUPERIORITY_OR_OTHER||LSM Difference|1.63|STANDARD_ERROR_OF_MEAN|1.285||0.2068|TWO_SIDED|80.0|-0.02|3.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||3.29|-0.02|0.2068
73868881|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.779||||0.4415|TWO_SIDED|95.0|0.412|1.475||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A||1.475|0.412|0.4415
73868882|NCT00265317|147282572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.458||||0.4682|TWO_SIDED|95.0|0.523|4.06||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A||4.060|0.523|0.4682
73868883|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.289||||0.7301|TWO_SIDED|95.0|0.304|5.47||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C||5.470|0.304|0.7301
73868884|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.788||||0.5013|TWO_SIDED|95.0|0.39|1.592||2-sided unstratified log-rank test|Log Rank|||PDGFRB/rs2304060 C/A||1.592|0.390|0.5013
73868885|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.368|TWO_SIDED|95.0|0.298|1.578||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: A/A||1.578|0.298|0.3680
73942493|NCT01939548|147417272|SUPERIORITY_OR_OTHER||LSM Difference|0.98|STANDARD_ERROR_OF_MEAN|1.326||0.4611|TWO_SIDED|80.0|-0.73|2.69||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||2.69|-0.73|0.4611
73974940|NCT04027439|147495786|OTHER||Contrast Ratio|1.2||||0.0041|TWO_SIDED|95.0|1.064|1.353|||ANCOVA|||||1.353|1.064|0.0041
73974941|NCT04027439|147495786|OTHER||Contrast Ratio|1.167||||0.0108|TWO_SIDED|95.0|1.039|1.311|||ANCOVA|||||1.311|1.039|0.0108
73974942|NCT04027439|147495786|OTHER||Contrast Ratio|1.087||||0.1641|TWO_SIDED|95.0|0.965|1.225|||ANCOVA|||||1.225|0.965|0.1641
73974943|NCT04027439|147495787|OTHER||Contrast Ratio|1.229||||0.0005|TWO_SIDED|95.0|1.102|1.369|||ANCOVA|||||1.369|1.102|0.0005
73868886|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738||||0.3804|TWO_SIDED|95.0|0.371|1.467||2-sided, unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C||1.467|0.371|0.3804
73868887|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.1507|TWO_SIDED|95.0|0.261|1.247||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T||1.247|0.261|0.1507
73974944|NCT04027439|147495787|OTHER||Contrast Ratio|1.231||||0.0005|TWO_SIDED|95.0|1.104|1.372|||ANCOVA|||||1.372|1.104|0.0005
73868888|NCT00265317|147282574|SUPERIORITY_OR_OTHER|||||||0.0772||||||2-sided unstratified log-rank test|Log Rank|||Locus PDGFRB/rs17656204 Genotype: T/T||||0.0772
73868889|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.2149|TWO_SIDED|95.0|0.339|1.284||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G||1.284|0.339|0.2149
73942494|NCT01939548|147417273|SUPERIORITY_OR_OTHER||LSM Difference|0.96|STANDARD_ERROR_OF_MEAN|0.591||0.1083|TWO_SIDED|80.0|0.19|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.72|0.19|0.1083
73942495|NCT01939548|147417273|SUPERIORITY_OR_OTHER||LSM Difference|1.05|STANDARD_ERROR_OF_MEAN|0.611||0.0869|TWO_SIDED|80.0|0.27|1.84||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.84|0.27|0.0869
73868890|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026||||0.9491|TWO_SIDED|95.0|0.466|2.26||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/RS2304061 Genotype: G/A||2.260|0.466|0.9491
73942496|NCT01939548|147417273|SUPERIORITY_OR_OTHER||LSM Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.575||0.8601|TWO_SIDED|80.0|-0.84|0.64||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.64|-0.84|0.8601
73942497|NCT01939548|147417273|SUPERIORITY_OR_OTHER||LSM Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.593||0.3454|TWO_SIDED|80.0|-1.33|0.2||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.20|-1.33|0.3454
73942498|NCT01939548|147417273|SUPERIORITY_OR_OTHER||LSM Difference|0.78|STANDARD_ERROR_OF_MEAN|0.789||0.3273|TWO_SIDED|80.0|-0.24|1.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.79|-0.24|0.3273
73942499|NCT01939548|147417273|SUPERIORITY_OR_OTHER||LSM Difference|0.69|STANDARD_ERROR_OF_MEAN|0.806||0.3963|TWO_SIDED|80.0|-0.35|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.72|-0.35|0.3963
73868891|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917||||0.8114|TWO_SIDED|95.0|0.447|1.881||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A||1.881|0.447|0.8114
73868892|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.577||||0.1379|TWO_SIDED|95.0|0.273|1.221||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T||1.221|0.273|0.1379
73868893|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.859||||0.5341|TWO_SIDED|95.0|0.256|13.51||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T||13.51|0.256|0.5341
73868894|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.932||||0.8564|TWO_SIDED|95.0|0.431|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A||2.014|0.431|0.8564
73942500|NCT01939548|147417273|SUPERIORITY_OR_OTHER||LSM Difference|0.64|STANDARD_ERROR_OF_MEAN|0.888||0.4713|TWO_SIDED|80.0|-0.5|1.78||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.78|-0.50|0.4713
73974945|NCT04027439|147495787|OTHER||Contrast Ratio|1.188||||0.0022|TWO_SIDED|95.0|1.07|1.32|||ANCOVA|||||1.320|1.070|0.0022
73974946|NCT04027439|147495787|OTHER||Contrast Ratio|1.106||||0.0658|TWO_SIDED|95.0|0.993|1.233|||ANCOVA|||||1.233|0.993|0.0658
73974947|NCT04027439|147495795|OTHER||Contrast Ratio|1.183|||<|0.0001|TWO_SIDED|95.0|1.134|1.234|||ANCOVA|||||1.234|1.134|<0.0001
73868895|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.5766|TWO_SIDED|95.0|0.355|1.788||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G||1.788|0.355|0.5766
73868896|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.467||||0.2043|TWO_SIDED|95.0|0.14|1.557||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G||1.557|0.140|0.2043
73868897|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.531||||0.1626|TWO_SIDED|95.0|0.214|1.317||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G||1.317|0.214|0.1626
73868898|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.986||||0.968|TWO_SIDED|95.0|0.484|2.006||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C||2.006|0.484|0.9680
73868899|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.3587|TWO_SIDED|95.0|0.171|1.92||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C||1.920|0.171|0.3587
73868900|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.742||||0.4635|TWO_SIDED|95.0|0.331|1.662||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G||1.662|0.331|0.4635
73868901|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.9834|TWO_SIDED|95.0|0.476|2.069||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A||2.069|0.476|0.9834
73868902|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.353||||0.1764|TWO_SIDED|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A||1.725|0.072|0.1764
73868903|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.2018|TWO_SIDED|95.0|0.422|1.209||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G||1.209|0.422|0.2018
73868904|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.85||||0.4592|TWO_SIDED|95.0|0.354|9.673||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A||9.673|0.354|0.4592
73868905|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.1593|TWO_SIDED|95.0|0.373|1.184||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T||1.184|0.373|0.1593
73868906|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.327||||0.5897|TWO_SIDED|95.0|0.469|3.755||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C||3.755|0.469|0.5897
73868907|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3681|TWO_SIDED|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C||1.309|0.488|0.3681
73868908|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.752||||0.3235|TWO_SIDED|95.0|0.423|1.336||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T||1.336|0.423|0.3235
73868909|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.845||||0.7463|TWO_SIDED|95.0|0.303|2.355||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G||2.355|0.303|0.7463
73868910|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.724||||0.4179|TWO_SIDED|95.0|0.33|1.593||2-sided unstratified log-rank test|Log Rank|||Locus: rs740751 Genotype: C/C||1.593|0.330|0.4179
73868911|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973||||0.9423|TWO_SIDED|95.0|0.462|2.05||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T||2.050|0.462|0.9423
73868912|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.353||||0.1764|TWO_SIDED|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs7407451 Genotype: T/T||1.725|0.072|0.1764
73868913|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.549||||0.2352|TWO_SIDED|95.0|0.201|1.501||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G||1.501|0.201|0.2352
73868914|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.986||||0.9674|TWO_SIDED|95.0|0.485|2.003||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A||2.003|0.485|0.9674
73868915|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.3524|TWO_SIDED|95.0|0.235|1.686||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A||1.686|0.235|0.3524
73868916|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.809||||0.6652|TWO_SIDED|95.0|0.308|2.124||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T||2.124|0.308|0.6652
73868917|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.839||||0.5931|TWO_SIDED|95.0|0.436|1.618||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G||1.618|0.436|0.5931
73868918|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.475||||0.2625|TWO_SIDED|95.0|0.125|1.813||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G||1.813|0.125|0.2625
73868919|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.2168|TWO_SIDED|95.0|0.4|1.239||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G||1.239|0.400|0.2168
73868920|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.987||||0.9802|TWO_SIDED|95.0|0.353|2.759||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A||2.759|0.353|0.9802
73868921|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.652||||0.1145|TWO_SIDED|95.0|0.378|1.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T||1.122|0.378|0.1145
73868922|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.192||||0.7725|TWO_SIDED|95.0|0.36|3.946||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A||3.946|0.360|0.7725
73868923|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.3286|TWO_SIDED|95.0|0.321|1.473||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A||1.473|0.321|0.3286
73868924|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.976||||0.948|TWO_SIDED|95.0|0.47|2.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G||2.028|0.470|0.9480
73868925|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.531||||0.3844|TWO_SIDED|95.0|0.125|2.282||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G||2.282|0.125|0.3844
73868926|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.662||||0.1373|TWO_SIDED|95.0|0.381|1.153||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G||1.153|0.381|0.1373
73868927|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.114||||0.8586|TWO_SIDED|95.0|0.339|3.667||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A||3.667|0.339|0.8586
73868928|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.935||||0.8478|TWO_SIDED|95.0|0.47|1.861||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G||1.861|0.470|0.8478
73868929|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.634||||0.2445|TWO_SIDED|95.0|0.287|1.401||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A||1.401|0.287|0.2445
73942501|NCT01939548|147417273|SUPERIORITY_OR_OTHER||LSM Difference|1.21|STANDARD_ERROR_OF_MEAN|0.895||0.1787|TWO_SIDED|80.0|0.06|2.36||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||2.36|0.06|0.1787
73942502|NCT01939548|147417273|SUPERIORITY_OR_OTHER||LSM Difference|0.35|STANDARD_ERROR_OF_MEAN|0.426||0.4123|TWO_SIDED|80.0|-0.2|0.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.90|-0.20|0.4123
73942503|NCT01939548|147417273|SUPERIORITY_OR_OTHER||LSM Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.441||0.3202|TWO_SIDED|80.0|-1.01|0.13||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.13|-1.01|0.3202
73942504|NCT01939548|147417274|SUPERIORITY_OR_OTHER||LSM Difference|0.04|STANDARD_ERROR_OF_MEAN|0.119||0.7399|TWO_SIDED|80.0|-0.11|0.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.19|-0.11|0.7399
73942505|NCT01939548|147417274|SUPERIORITY_OR_OTHER||LSM Difference|0.13|STANDARD_ERROR_OF_MEAN|0.122||0.2747|TWO_SIDED|80.0|-0.02|0.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.29|-0.02|0.2747
73942506|NCT01939548|147417275|SUPERIORITY_OR_OTHER||LSM Difference|0.07|STANDARD_ERROR_OF_MEAN|0.188||0.7219|TWO_SIDED|80.0|-0.17|0.31||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.||0.31|-0.17|0.7219
73942507|NCT01939548|147417275|SUPERIORITY_OR_OTHER||LSM Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.192||0.9315|TWO_SIDED|80.0|-0.26|0.23||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.||0.23|-0.26|0.9315
73868930|NCT00265317|147282574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.155||||0.9191|TWO_SIDED|95.0|0.072|18.59||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A||18.59|0.072|0.9191
73868931|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.121||||0.8563|TWO_SIDED|95.0|0.326|3.847||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C||3.847|0.326|0.8563
73942508|NCT00101933|147417292|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||Since a treatment-by-visit interaction remains in the final model, the results were analyzed by visit. The results shown are for the last month in the blinded phase (month 3-4).|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.||||0.0017
73942509|NCT00101933|147417294|SUPERIORITY_OR_OTHER||Rate per 1000 years of stimulation|4.9|||||TWO_SIDED|95.0|0.6|17.79|||No statistical test||The rate is calculated per 1000 subject years of follow-up based on 406 subject years of stimulation. The confidence interval is the 95% Poisson confidence interval. Per protocol, only definite and probable SUDEP were included in the calculation.|||17.79|0.60|
73974948|NCT04027439|147495795|OTHER||Contrast Ratio|1.14|||<|0.0001|TWO_SIDED|95.0|1.092|1.19|||ANCOVA|||||1.190|1.092|<0.0001
73974949|NCT04027439|147495795|OTHER||Contrast Ratio|1.131|||<|0.0001|TWO_SIDED|95.0|1.084|1.18|||ANCOVA|||||1.180|1.084|<0.0001
73868932|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.7375|TWO_SIDED|95.0|0.599|2.064||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/A||2.064|0.599|0.7375
73974950|NCT04027439|147495795|OTHER||Contrast Ratio|1.08||||0.0004|TWO_SIDED|95.0|1.036|1.126|||ANCOVA|||||1.126|1.036|0.0004
73974951|NCT04027439|147495796|OTHER||Contrast Ratio|1.123|||<|0.0001|TWO_SIDED|95.0|1.078|1.169|||ANCOVA|||||1.169|1.078|<0.0001
73868933|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.897||||0.8066|TWO_SIDED|95.0|0.375|2.147||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs234060 Genotype: A/A||2.147|0.375|0.8066
73868934|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.6945|TWO_SIDED|95.0|0.449|1.708||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C||1.708|0.449|0.6945
73868935|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.067||||0.8536|TWO_SIDED|95.0|0.536|2.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T||2.122|0.536|0.8536
73942510|NCT00101933|147417295|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Fisher Exact|||Fisher's Exact test. The numbers presented in this analysis are the number of subjects who were responders based on a responder definition including all subjects with 50% or greater improvement in total seizure count.||||0.830
73974952|NCT04027439|147495796|OTHER||Contrast Ratio|1.078||||0.0004|TWO_SIDED|95.0|1.035|1.122|||ANCOVA|||||1.122|1.035|0.0004
73974953|NCT04027439|147495796|OTHER||Contrast Ratio|1.081||||0.0002|TWO_SIDED|95.0|1.039|1.125|||ANCOVA|||||1.125|1.039|0.0002
73868936|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.732||||0.3657|TWO_SIDED|95.0|0.283|26.42||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: T/T||26.42|0.283|0.3657
73974954|NCT04027439|147495796|OTHER||Contrast Ratio|1.041||||0.0437|TWO_SIDED|95.0|1.001|1.083|||ANCOVA|||||1.083|1.001|0.0437
73974955|NCT04027439|147495797|OTHER||Contrast Ratio|1.087||||0.0006|TWO_SIDED|95.0|1.038|1.139|||ANCOVA|||||1.139|1.038|0.0006
73974956|NCT04027439|147495797|OTHER||Contrast Ratio|1.083||||0.001|TWO_SIDED|95.0|1.034|1.135|||ANCOVA|||||1.135|1.034|0.0010
74031337|NCT00418262|147616147|SUPERIORITY||Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||1.38|-0.69|
73868937|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.4657|TWO_SIDED|95.0|0.424|1.483||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G||1.483|0.424|0.4657
73868938|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.364||||0.4168|TWO_SIDED|95.0|0.641|2.9||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/A||2.900|0.641|0.4168
73974957|NCT04027439|147495797|OTHER||Contrast Ratio|1.096||||0.0002|TWO_SIDED|95.0|1.047|1.149|||ANCOVA|||||1.149|1.047|0.0002
73974958|NCT04027439|147495797|OTHER||Contrast Ratio|1.039||||0.0971|TWO_SIDED|95.0|0.993|1.088|||ANCOVA|||||1.088|0.993|0.0971
73974959|NCT04027439|147495798|OTHER||Contrast Ratio|1.145|||<|0.0001|TWO_SIDED|95.0|1.106|1.185|||ANCOVA|||||1.185|1.106|<0.0001
73974960|NCT04027439|147495798|OTHER||Contrast Ratio|1.148|||<|0.0001|TWO_SIDED|95.0|1.109|1.189|||ANCOVA|||||1.189|1.109|<0.0001
73942511|NCT00101933|147417296|SUPERIORITY_OR_OTHER|||||||0.105||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.105
73974961|NCT04027439|147495798|OTHER||Contrast Ratio|1.099|||<|0.0001|TWO_SIDED|95.0|1.062|1.137|||ANCOVA|||||1.137|1.062|<0.0001
73974962|NCT04027439|147495798|OTHER||Contrast Ratio|1.088|||<|0.0001|TWO_SIDED|95.0|1.052|1.126|||ANCOVA|||||1.126|1.052|<0.0001
73974963|NCT04027439|147495799|OTHER||Contrast Ratio|1.15|||<|0.0001|TWO_SIDED|95.0|1.113|1.189|||ANCOVA|||||1.189|1.113|<0.0001
73974964|NCT04027439|147495799|OTHER||Contrast Ratio|1.146|||<|0.0001|TWO_SIDED|95.0|1.109|1.185|||ANCOVA|||||1.185|1.109|<0.0001
73868939|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.908||||0.7836|TWO_SIDED|95.0|0.456|1.809||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A||1.809|0.456|0.7836
73974965|NCT04027439|147495799|OTHER||Contrast Ratio|1.107|||<|0.0001|TWO_SIDED|95.0|1.071|1.144|||ANCOVA|||||1.144|1.071|<0.0001
73974966|NCT04027439|147495799|OTHER||Contrast Ratio|1.094|||<|0.0001|TWO_SIDED|95.0|1.059|1.13|||ANCOVA|||||1.130|1.059|<0.0001
73974967|NCT04027439|147495800|OTHER||Contrast Ratio|1.103|||<|0.0001|TWO_SIDED|95.0|1.066|1.141|||ANCOVA|||||1.141|1.066|<0.0001
73974968|NCT04027439|147495800|OTHER||Contrast Ratio|1.078|||<|0.0001|TWO_SIDED|95.0|1.042|1.116|||ANCOVA|||||1.116|1.042|<0.0001
73974969|NCT04027439|147495800|OTHER||Contrast Ratio|1.067||||0.0002|TWO_SIDED|95.0|1.032|1.104|||ANCOVA|||||1.104|1.032|0.0002
73974970|NCT04027439|147495800|OTHER||Contrast Ratio|1.048||||0.0066|TWO_SIDED|95.0|1.013|1.084|||ANCOVA|||||1.084|1.013|0.0066
73974971|NCT05580003|147495848|OTHER||Ratio of Adjusted Geometric Means|101.29|||||TWO_SIDED|90.0|95.71|107.18|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUCinf||107.18|95.71|
73974972|NCT05580003|147495848|OTHER||Ratio of Adjusted Geometric Means|102.74|||||TWO_SIDED|90.0|97.28|108.5|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUCinf||108.50|97.28|
73974973|NCT05580003|147495848|OTHER||Ratio of Adjusted Geometric Means|97.83|||||TWO_SIDED|90.0|91.32|104.8|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUClast||104.80|91.32|
73974974|NCT05580003|147495848|OTHER||Ratio of Adjusted Geometric Means|102.41|||||TWO_SIDED|90.0|95.6|109.7|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUClast||109.70|95.60|
73868940|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.938||||0.8531|TWO_SIDED|95.0|0.472|1.863||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T||1.863|0.472|0.8531
73868941|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.32||||0.3272|TWO_SIDED|95.0|0.412|13.07||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T||13.07|0.412|0.3272
73868942|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984||||0.963|TWO_SIDED|95.0|0.491|1.972||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A||1.972|0.491|0.9630
73868943|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.227||||0.6003|TWO_SIDED|95.0|0.567|2.656||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G||2.656|0.567|0.6003
73942512|NCT00101933|147417297|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.498
73942513|NCT00101933|147417298|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
73942514|NCT00101933|147417299|SUPERIORITY_OR_OTHER|||||||0.0387||95.0||||Since a visit-by-treatment interaction did not remain in the final model, the results shown are for the entire blinded phase.|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.||||0.0387
73942515|NCT00101933|147417300|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||Numbers provided indicate the percentage change from baseline in seizure frequency of each participant's most severe seizures. Negative values indicate improvement from baseline.||||0.047
73942516|NCT00774579|147417301|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
73942517|NCT00774579|147417302|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
73942518|NCT02638948|147417321|SUPERIORITY||Estimate of Difference (%)|4.9||||0.5224|TWO_SIDED|95.0|-10.2|20.1||Threshold for significance = 0.05|Chi-squared|||||20.1|-10.2|0.5224
73942519|NCT02638948|147417321|SUPERIORITY||Estimate of Difference (%)|11.8||||0.136|TWO_SIDED|95.0|-3.6|27.2||Threshold for significance = 0.05|Chi-squared|||||27.2|-3.6|0.1360
73942520|NCT02638948|147417321|SUPERIORITY||Estimate of Difference (%)|0.1||||0.9922|TWO_SIDED|95.0|-20.5|20.7||Threshold for significance = 0.05|Chi-squared|||||20.7|-20.5|0.9922
73942521|NCT02638948|147417322|SUPERIORITY||Estimate of Difference (%)|0.1||||1|TWO_SIDED|95.0|-16.0|16.5||Threshold for significance = 0.05|Chi-squared|||||16.5|-16.0|1.0000
73868944|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.769||||0.6703|TWO_SIDED|95.0|0.229|2.58||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G||2.580|0.229|0.6703
73868945|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.106||||0.81|TWO_SIDED|95.0|0.485|2.525||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G||2.525|0.485|0.8100
73942522|NCT02638948|147417322|SUPERIORITY||Estimate of Difference (%)|5.6||||0.2058|TWO_SIDED|95.0|-10.5|21.9||Threshold for significance = 0.05|Chi-squared|||||21.9|-10.5|0.2058
73942523|NCT02638948|147417322|SUPERIORITY||Estimate of Difference (%)|-0.2||||1|TWO_SIDED|95.0|-22.5|22.2||Threshold for significance = 0.05|Chi-squared|||||22.2|-22.5|1.0000
73942524|NCT02963974|147417346|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed CNC Word scores from 3 months through 24 months to evaluate change over time with device use. Scores were converted to Rau prior to analysis.||||< 0.001
73942525|NCT02963974|147417346|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||Analyzed pre-op to 3 month post activation CNC Word scores to test superiority of cochlear implant use to pre-operative hearing aid use.||||< 0.001
73942526|NCT02963974|147417348|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05. This was a two-way repeated measures ANOVA.|ANOVA|||Analyzed BKB-SIN SNR-50 scores at 12 months post activation to evaluate the impact of device use (CI off vs on) and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.||||< 0.001
73942527|NCT02963974|147417349|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed BKB-SIN SNR-50 scores across all time points (6, 12, and 24 months post activation) to evaluate the impact of time, device use (CI off vs on), and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.||||< 0.001
73942528|NCT02963974|147417353|SUPERIORITY|||||||0.01911||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed overall RMS error at 3, 9, 18, and 24 months post activation to evaluate the impact of device use (CI off vs on) and time on localization.||||0.01911
73974975|NCT05580003|147495849|OTHER||Ratio of Adjusted Geometric Means|67.18|||||TWO_SIDED|90.0|58.13|77.65|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|||77.65|58.13|
73974976|NCT05580003|147495849|OTHER||Ratio of Adjusted Geometric Means|74.12|||||TWO_SIDED|90.0|64.14|85.67|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|||85.67|64.14|
73974977|NCT05580003|147495885|OTHER||Ratio of Adjusted Geometric Means|72.87|||||TWO_SIDED|90.0|60.98|87.09|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUCinf||87.09|60.98|
73868946|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.076||||0.8335|TWO_SIDED|95.0|0.541|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C||2.141|0.541|0.8335
73942529|NCT02963974|147417354|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Speech subtest.||||< 0.001
73942530|NCT02963974|147417354|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Spatial subtest.||||0.001
73942531|NCT02963974|147417354|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Qualities subtest.||||< 0.001
73942532|NCT02963974|147417355|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores over time.||||< 0.001
73942533|NCT02963974|147417356|SUPERIORITY|||||||0.1009||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores to evaluation change over time: General Fatigue Subtest||||0.1009
73942534|NCT02963974|147417356|SUPERIORITY|||||||0.109||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores to evaluation change over time: Sleep Fatigue Subtest||||0.109
73942535|NCT02963974|147417356|SUPERIORITY|||||||0.1733||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores to evaluation change over time: Cognitive Fatigue Subtest||||0.1733
73942536|NCT00810264|147417357|NON_INFERIORITY|The primary safety endpoint 1 hypothesis was evaluated by performing an exact, non-inferiority test comparing a binomial proportion (overall SAEFR at 5 years) to 92.5%, with a non-inferiority delta of 5%.|||||<|0.0001|||||||Binomial Proportion|||||||<0.0001
73974978|NCT05580003|147495885|OTHER||Ratio of Adjusted Geometric Means|76.45|||||TWO_SIDED|90.0|68.35|85.52|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUCinf||85.52|68.35|
73974979|NCT05580003|147495885|OTHER||Ratio of Adjusted Geometric Means|73.52|||||TWO_SIDED|90.0|65.7|82.27|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUClast||82.27|65.70|
73974980|NCT05580003|147495885|OTHER||Ratio of Adjusted Geometric Means|75.16|||||TWO_SIDED|90.0|66.36|85.13|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUClast||85.13|66.36|
73974981|NCT05580003|147495886|OTHER||Ratio of Adjusted Geometric Means|76.72|||||TWO_SIDED|90.0|60.21|97.75|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|||97.75|60.21|
73974982|NCT05580003|147495886|OTHER||Ratio of Adjusted Geometric Means|70.92|||||TWO_SIDED|90.0|53.7|93.67|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|||93.67|53.70|
73974983|NCT02029235|147495923|OTHER|||||||0.24|||||||t-test, 2 sided|||"Null hypothesis: No difference between groups~Power analysis: A sample size of 16 in each group had an 80% power to detect a difference in means of 10 mm."||||0.24
73974984|NCT02029235|147495924|OTHER|||||||0.06|||||||t-test, 2 sided|||Null hypothesis: No difference between groups||||0.06
73974985|NCT04057820|147495945|SUPERIORITY||Incidence rate ratio (IRR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.46|0.65|||Mixed Models Analysis|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.65|0.46|<0.0001
73974986|NCT04057820|147495946|SUPERIORITY||Risk Ratio (RR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.3|0.47|||Mixed-effect Poisson w/ robust err var|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.47|0.30|<0.0001
73974987|NCT04057820|147495947|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|-0.4|4.9||||||||4.9|-0.4|
73974988|NCT04057820|147495948|SUPERIORITY||Mean Difference (Final Values)|23.0|||||TWO_SIDED|95.0|8.1|37.9||||||||37.9|8.1|
73974989|NCT04057820|147495949|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.37|1.76||||||||1.76|0.37|
73974990|NCT04057820|147495950|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.3|1.0|||Mixed Models Analysis|||||1.0|-0.3|
73974991|NCT04057820|147495951|SUPERIORITY||Risk Ratio (RR)|1.94|||||TWO_SIDED|95.0|0.94|3.99||||||||3.99|0.94|
73974992|NCT04057820|147495952|SUPERIORITY||Risk Ratio (RR)|1.68|||||TWO_SIDED|95.0|1.13|2.48||||||||2.48|1.13|
73974993|NCT04057820|147495953|SUPERIORITY||Incidence ratio ratio (IRR)|0.56|||||TWO_SIDED|95.0|0.49|0.64|||Mixed Models Analysis|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.64|0.49|
73974994|NCT04057820|147495955|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.71|1.47||||||||1.47|0.71|
73974995|NCT03160885|147495974|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|11.1|||<|0.001|TWO_SIDED|95.0|5.8|16.4||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||16.4|5.8|<0.001
73974996|NCT03160885|147495975|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|21.6|||<|0.001|TWO_SIDED|95.0|15.8|27.3||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||27.3|15.8|<0.001
73974997|NCT03160885|147495976|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|10.3|20.9||Based on the primary analysis of the primary estimand 'Composite', subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders'.|Cochran-Mantel-Haenszel|Tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Reduction of Worst Daily Pruritus NRS weekly average ≥4 at Week 16 was tested after the sequential testing of IGA 0/1 and EASI75 if these tests showed statistical significance||20.9|10.3|<0.001
73974998|NCT03160885|147495977|SUPERIORITY|Multiplicity adjustment using the Holm method.|Difference of least square means|-14.0|||<|0.001|TWO_SIDED|95.0|-18.0|-10.1||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-10.1|-18.0|<0.001
73974999|NCT03160885|147495978|SUPERIORITY|Multiplicity adjustment using Holm method.|Difference of least square means|-3.9|||<|0.001|TWO_SIDED|95.0|-5.2|-2.6||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-2.6|-5.2|<0.001
74031338|NCT00064662|147616148|SUPERIORITY_OR_OTHER||Other|0.0||||0.01||95.0|||||Log Rank|||Time to event analysis of 24 month success rates. Null hypothesis is that the distributions in the two groups are equal.||||0.01
74031339|NCT00064662|147616149|SUPERIORITY_OR_OTHER||Chi-square|16.2|||<|0.001||95.0|||||Log Rank|||Time to event analysis of cumulative success rates in the two groups. Null hypothesis is that the distributions are equal in the two groups.||||<0.001
74031340|NCT00064662|147616149|SUPERIORITY_OR_OTHER||Other|0.0|||<|0.0001||95.0|||||Kalpan Meier (Wald statistic)|||Kaplan Meier time-to-event analysis of cumulative success rates. Used Wald test of equality of survival distributions.||||<0.0001
73942537|NCT03063294|147417388|SUPERIORITY||Difference in Difference|0.02|||||TWO_SIDED|95.0|-0.47|0.5|||||"The difference in difference equals the follow-up minus baseline change in Hassles scale results for the toolkit plus coaching clinics, minus the follow-up minus baseline change in the Hassles scale results for the toolkit only clinics."|"Zero-inflated negative binomial regression was used to obtain predicted mean Hassles scale scores for the toolkit only clinics and toolkit plus coaching clinics at baseline and follow-up, adjusting for study design and characteristics of survey respondents. The difference-in-difference was then computed as described below, under method of estimation. Bootstrap resampling was used to calculate the 95% confidence intervals around the predicted means and the difference-in-difference."||0.50|-0.47|
73942538|NCT02134587|147417402|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.00001
73942539|NCT02134587|147417403|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73942540|NCT01515748|147417408|SUPERIORITY|||||||0.0152||||||Threshold for statistical significance at 0.049.|Stratified Log Rank|||Analysis was performed using Kaplan-Meier method. Comparison was stratified based on site and TNM classification (T4/N-, T2/N+, T3-4/N+).||||0.0152
73942541|NCT00416182|147417418|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0||||P-value of \< 0.05 is considered significant|t-test, 2 sided|||||||0.2
73942542|NCT00416182|147417419|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|95.0||||P-value of \< 0.05 is considered significant.|t-test, 2 sided|||||||0.048
73942543|NCT00416182|147417420|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0||||P-value \< 0.05 is considered significant|t-test, 2 sided|||||||0.003
73942544|NCT00416182|147417421|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||P \<0.05 is considered significant|t-test, 2 sided|||||||0.4
73868947|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.598|TWO_SIDED|95.0|0.268|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C||2.141|0.268|0.5980
73942545|NCT04102579|147417445|OTHER||Least Squares (LS) Means Difference|-3.16|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-4.37|-1.95||Statistical significance achieved if p-value \<0.05.|MMRM||LS Means Difference = Valbenazine - Placebo|Results were analyzed using a mixed-effect model repeated measures (MMRM) analysis. The model included the screening period baseline TMC as a covariate, and treatment group, visit, treatment group-by-visit interaction, and baseline-by-visit interaction as fixed effects. Participant was included as a random effect.||-1.95|-4.37|<0.0001
73942546|NCT04102579|147417446|OTHER||Percent Difference in Responders|29.65||||0.0007|TWO_SIDED|95.0|10.77|45.37||Statistical significance achieved if p-value \<0.05.|Fisher Exact||Percent Difference in Responders (%) = Valbenazine - Placebo|||45.37|10.77|0.0007
73942547|NCT04102579|147417447|OTHER||Percent Difference in Responders|26.31||||0.0062|TWO_SIDED|95.0|6.32|43.74||Statistical significance achieved if p-value \<0.05.|Fisher Exact||Percent Difference in Responders (%) = Valbenazine - Placebo|||43.74|6.32|0.0062
73942548|NCT04102579|147417448|OTHER||LS Means Difference|1.42|STANDARD_ERROR_OF_MEAN|1.46||0.3304|TWO_SIDED|95.0|-1.46|4.31||Statistical significance achieved if p-value \<0.05.|MMRM||LS Means Difference = Valbenazine - Placebo|LS mean was based on the MMRM model which included corresponding baseline value of the Neuro-QoL Upper Extremity Function T-score as a covariate; treatment group, visit, baseline-by-visit interaction, and treatment group-by-visit interaction as fixed effects; and participant as a random effect.||4.31|-1.46|0.3304
73942549|NCT01165775|147417451|SUPERIORITY_OR_OTHER|||||||0.2155|||||||Chi-squared|||||||0.2155
73942550|NCT01337674|147417453|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|-1.22|||||TWO_SIDED|90.0|-8.42|5.98|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1||5.98|-8.42|
73942551|NCT01337674|147417453|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|2.29|||||TWO_SIDED|90.0|-4.92|9.49|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7||9.49|-4.92|
73868948|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.9287|TWO_SIDED|95.0|0.487|2.199||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G||2.199|0.487|0.9287
73868949|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.053||||0.8842|TWO_SIDED|95.0|0.526|2.106||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A||2.106|0.526|0.8842
73942552|NCT01337674|147417453|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|1.65|||||TWO_SIDED|90.0|-5.31|8.62|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1||8.62|-5.31|
73942553|NCT01337674|147417453|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|-1.09|||||TWO_SIDED|90.0|-8.06|5.88|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7||5.88|-8.06|
74031341|NCT00872833|147616151|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<.001
74031342|NCT00872833|147616152|SUPERIORITY_OR_OTHER|||||||0.028|||||||Chi-squared|||||||0.028
74031343|NCT02650284|147616155|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.46||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at pre-operation timepoint.||||0.46
73868950|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.129||||0.8501|TWO_SIDED|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A||4.028|0.316|0.8501
73868951|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.229||||0.4118|TWO_SIDED|95.0|0.749|2.017||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G||2.017|0.749|0.4118
73868952|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.286||||0.1299|TWO_SIDED|95.0|0.051|1.596||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A||1.596|0.051|0.1299
73868953|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.1859|TWO_SIDED|95.0|0.399|1.2||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T||1.200|0.399|0.1859
73868954|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.672||||0.0091|TWO_SIDED|95.0|1.291|10.44||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C||10.44|1.291|0.0091
73868955|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8708|TWO_SIDED|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C||1.652|0.654|0.8708
73868956|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.9888|TWO_SIDED|95.0|0.59|1.681||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T||1.681|0.590|0.9888
73942554|NCT01337674|147417454|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|1.95|||||TWO_SIDED|90.0|-2.85|6.75|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1||6.75|-2.85|
73868957|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9702|TWO_SIDED|95.0|0.36|2.891||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G||2.891|0.360|0.9702
73868958|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973||||0.9419|TWO_SIDED|95.0|0.466|2.032||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/C||2.032|0.466|0.9419
73868959|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.112||||0.7677|TWO_SIDED|95.0|0.549|2.252||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T||2.252|0.549|0.7677
73942555|NCT01337674|147417454|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-5.91|||||TWO_SIDED|90.0|-10.71|-1.11|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7||-1.11|-10.71|
73868960|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.129||||0.8501|TWO_SIDED|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: T/T||4.028|0.316|0.8501
73868961|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.5233|TWO_SIDED|95.0|0.322|1.782||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G||1.782|0.322|0.5233
73868962|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.123||||0.75|TWO_SIDED|95.0|0.549|2.297||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A||2.297|0.549|0.7500
73868963|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232||||0.6614|TWO_SIDED|95.0|0.483|3.142||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A||3.142|0.483|0.6614
73868964|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.779||||0.2552|TWO_SIDED|95.0|0.652|4.855||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T||4.855|0.652|0.2552
73868965|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.088||||0.7931|TWO_SIDED|95.0|0.577|2.052||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G||2.052|0.577|0.7931
73868966|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.449||||0.1365|TWO_SIDED|95.0|0.152|1.331||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G||1.331|0.152|0.1365
73868967|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854||||0.5544|TWO_SIDED|95.0|0.504|1.447||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G||1.447|0.504|0.5544
73868968|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.721||||0.3132|TWO_SIDED|95.0|0.59|5.021||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A||5.021|0.590|0.3132
73868969|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.263||||0.3698|TWO_SIDED|95.0|0.755|2.113||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T||2.113|0.755|0.3698
73868970|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.411||||0.1495|TWO_SIDED|95.0|0.119|1.423||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A||1.423|0.119|0.1495
73868971|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.613||||0.1911|TWO_SIDED|95.0|0.781|3.332||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A||3.332|0.781|0.1911
73868972|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.5259|TWO_SIDED|95.0|0.384|1.636||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G||1.636|0.384|0.5259
73868973|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.331||||0.0996|TWO_SIDED|95.0|0.082|1.339||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G||1.339|0.082|0.0996
73868974|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.752||||0.2755|TWO_SIDED|95.0|0.45|1.259||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G||1.259|0.450|0.2755
73868975|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.85||||0.012|TWO_SIDED|95.0|1.253|18.78||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A||18.78|1.253|0.0120
73868976|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.274||||0.4663|TWO_SIDED|95.0|0.661|2.457||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G||2.457|0.661|0.4663
73942556|NCT01337674|147417454|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-6.25|||||TWO_SIDED|90.0|-11.47|-1.03|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1||-1.03|-11.47|
73942557|NCT01337674|147417454|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-1.57|||||TWO_SIDED|90.0|-6.79|3.65|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7||3.65|-6.79|
73942558|NCT02178059|147417466|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \<1.25 provided that the true mean ratios are \<1.05.|Ratio of geometric means (%)|88.2|||||TWO_SIDED|90.0|81.03|96.02|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25||96.02|81.03|
73975000|NCT03160885|147495979|SUPERIORITY||Risk Difference (RD)|34.1||||0.004|TWO_SIDED|95.0|13.4|54.9||Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||54.9|13.4|0.004
74089222|NCT00391079|147731467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.309||||0.2338|TWO_SIDED|95.0|0.84|2.038|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each Sativex and placebo.||2.038|0.840|0.2338
74089223|NCT00391079|147731468|SUPERIORITY_OR_OTHER||Estimated treatment effect|-1.83||||0.3103|TWO_SIDED|95.0|-5.39|1.72|||ANOVA||A negative difference in estimated treatment effect indicates an improvement in pain in favour of Sativex.|The change in NPS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||1.72|-5.39|0.3103
74089224|NCT00391079|147731469|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.24||||0.1567|TWO_SIDED|95.0|-0.57|0.09|||ANCOVA||A negative difference in estimated treatment difference indicates a reduction in breakthrough analgesic medication in favour of Sativex.|The change in average number of tablets taken daily from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||0.09|-0.57|0.1567
73868977|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.867||||0.7097|TWO_SIDED|95.0|0.406|1.848||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A||1.848|0.406|0.7097
73942559|NCT02178059|147417467|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8052|TWO_SIDED|90.0|-0.17|0.17|||Wilcoxon signed rank test|||||0.17|-0.17|0.8052
74009011|NCT01641237|147568704|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.57||||0.0017|TWO_SIDED|95.0|4.4|18.74||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||18.74|4.40|0.0017
74089225|NCT00391079|147731470|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.12||||0.5643|TWO_SIDED|95.0|-0.53|0.29|||ANCOVA||A negative difference in estimated means indicates an improvement in pain in favour of Sativex.|||0.29|-0.53|0.5643
74089226|NCT00391079|147731471|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.47||||0.0552|TWO_SIDED|95.0|0.991|2.179|||Regression, Logistic||An odds ratio of greater than 1 indicates and improvement in favour of Sativex.|||2.179|0.991|0.0552
74089227|NCT00391079|147731472|SUPERIORITY_OR_OTHER||estimated treatment difference|0.05||||0.833|TWO_SIDED|95.0|-0.39|0.48|||ANCOVA||A negative difference in estimated treatment difference indicates an improvement in sleep quality in favour of Sativex.|||0.48|-0.39|0.8330
74089228|NCT01173471|147731489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|5.352||0.822|TWO_SIDED|95.0|-15.2|12.6|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)|||12.6|-15.2|0.822
73868978|NCT00265317|147282575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.607||||0.534|TWO_SIDED|95.0|0.117|3.158||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A||3.158|0.117|0.5340
73868979|NCT00265317|147282578|SUPERIORITY_OR_OTHER|||||||0.2702|||||||Wilcoxon Rank Sum Test|||VEGF-C Ratio to Baseline for Cycle 2, Day 1||||0.2702
73868980|NCT00265317|147282578|SUPERIORITY_OR_OTHER|||||||0.7354||95.0|||||Wilcoxon Rank Sum Test|||VEGF-C ratio to Baseline for Cycle 3, Day 1||||0.7354
73868981|NCT00265317|147282580|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 2, Day 1||||<0.0001
73868982|NCT00265317|147282580|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 3, Day 1||||<0.0001
73868983|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.553||||0.1667|TWO_SIDED|95.0|0.159|1.921||1-sided unstratified log-rank test|Log Rank|||High CSF-1R expression||1.921|0.159|0.1667
73868984|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.451||||0.7688|TWO_SIDED|95.0|0.534|3.944||1-sided unstratified log-rank test|Log Rank|||Low CSF-1R expression||3.944|0.534|0.7688
73868985|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3498|TWO_SIDED|95.0|0.503|1.574||1-sided unstratified log-rank test|Log Rank|||Indeterminate CSF-1R expression||1.574|0.503|0.3498
73868986|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.687||||0.9497|TWO_SIDED|95.0|0.79|9.143||1-sided unstratified log-rank test|Log Rank|||High PDGFRalpha expression||9.143|0.790|0.9497
73868987|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.386||||0.0401|TWO_SIDED|95.0|0.127|1.173||1-sided unstratified log-rank test|Log Rank|||Low PDGFRalpha expression||1.173|0.127|0.0401
73868988|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.862||||0.3128|TWO_SIDED|95.0|0.487|1.524||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRalpha expression||1.524|0.487|0.3128
73942560|NCT02178059|147417471|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \<1.25 provided that the true mean ratios are \<1.05.|Ratio of geometric means (%)|91.44|||||TWO_SIDED|90.0|84.82|98.58|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25||98.58|84.82|
73942561|NCT00838682|147417489|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
73942562|NCT00838682|147417490|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
73942563|NCT00838682|147417491|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
73942564|NCT00838682|147417492|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
73868989|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.823||||0.365|TWO_SIDED|95.0|0.273|2.488||1-sided unstratified log-rank test|Log Rank|||High PDGFRbeta expression||2.488|0.273|0.3650
73942565|NCT00838682|147417493|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73942566|NCT00838682|147417494|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73942567|NCT00990964|147417510|SUPERIORITY_OR_OTHER||One sample proportion|0.94|||||TWO_SIDED|95.0|0.929|0.951||||||||.951|.929|
73942568|NCT00990964|147417511|SUPERIORITY_OR_OTHER||One sample proportion|0.974|||||TWO_SIDED|95.0|0.965|0.98||||||||.980|.965|
73942569|NCT04098406|147417522|SUPERIORITY||Mean Difference (Final Values)|7.7||||0.4304|TWO_SIDED|95.0|-11.9|27.3|||MMRM|||||27.3|-11.9|0.4304
73868990|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.192||||0.6105|TWO_SIDED|95.0|0.408|3.48||1-sided unstratified log-rank test|Log Rank|||Low PDGFRbeta expression||3.480|0.408|0.6105
73868991|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856||||0.3027|TWO_SIDED|95.0|0.488|1.502||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRbeta expression||1.502|0.488|0.3027
73942570|NCT04098406|147417523|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.6519|TWO_SIDED|95.0|-12.4|19.7|||MMRM|||||19.7|-12.4|0.6519
73868992|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.914||||0.4436|TWO_SIDED|95.0|0.262|3.184||1-sided unstratified log-rank test|Log Rank|||High VEGF expression||3.184|0.262|0.4436
73868993|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.4582|TWO_SIDED|95.0|0.296|3.062||1-sided unstratified log-rank test|Log Rank|||Low VEGF expression||3.062|0.296|0.4582
73868994|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.911||||0.372|TWO_SIDED|95.0|0.536|1.548||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF expression||1.548|0.536|0.3720
73868995|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.5586|TWO_SIDED|95.0|0.35|3.397||1-sided unstratified log-rank test|Log Rank|||High VEGF-C expression||3.397|0.350|0.5586
73868996|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.842||||0.3652|TWO_SIDED|95.0|0.313|2.266||1-sided unstratified log-rank test|Log Rank|||Low VEGF-C expression||2.266|0.313|0.3652
73868997|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.3301|TWO_SIDED|95.0|0.493|1.554||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF-C expression||1.554|0.493|0.3301
73942571|NCT04098406|147417524|SUPERIORITY||Mean Difference (Final Values)|18.8||||0.6158|TWO_SIDED|95.0|-56.4|94.0|||MMRM|||||94.0|-56.4|0.6158
73942572|NCT04098406|147417529|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.4249|TWO_SIDED|95.0|-1.6|3.6|||MMRM|||||3.6|-1.6|0.4249
73942573|NCT04098406|147417530|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.0350
73942574|NCT04098406|147417532|SUPERIORITY||Mean Difference (Final Values)|9.1||||0.2237|TWO_SIDED|95.0|-5.8|23.9|||ANCOVA|||||23.9|-5.8|0.2237
73942575|NCT04098406|147417533|SUPERIORITY||Hazard Ratio (HR)|0.29||||0.0125|TWO_SIDED|95.0|0.103|0.815|||Log Rank|||||0.815|0.103|0.0125
73942576|NCT04098406|147417535|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.0177|TWO_SIDED|95.0|0.2|1.6|||MMRM|||||1.6|0.2|0.0177
73942577|NCT00415610|147417557|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The repeated measure analysis of the hourly average SBP was calculated with and without adjusting for baseline NIHSS and age.|repeated measure|Adjusted for initial deficit severity of using baseline NIHSS instead of GCS to better discriminate among patients with GCS score \> 8.||The hourly average (of maximum and minimum) SBP measurements were graphed with box-and-whiskers plot. In addition, a repeated measures analysis of the 25 average SBP (baseline and subsequent 24 hourly measures) was conducted with a mixed effects model (assuming autoregressive covariance structure in SAS version 9.1 PROC MIXED) to determine statistically the effect of treatment intensity (tier) on the average SBP over the 24 hrs with and without adjustment for baseline NIHSS score and age.||||< 0.01
73942578|NCT00415610|147417558|SUPERIORITY_OR_OTHER||||||<|0.5|TWO_SIDED|||||Observed average SBP change at 2 hrs after treatment initiation between subjects who did or did not have neurologic deterioration within 24 hrs.|Wilcoxon rank sum test|Mean decrease measured for subjects with neurological deterioration and subjects without neurological deterioration.||Done as a surrogate to evaluate the relationship between early SBP reduction and safety events.||||< .5
74089229|NCT01173471|147731489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|3.516||0.413|TWO_SIDED|95.0|-10.1|4.3|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)|||4.3|-10.1|0.413
73868998|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.5605|TWO_SIDED|95.0|0.331|3.636||1-sided unstratified log-rank test|Log Rank|||High VEGFR1 expression||3.636|0.331|0.5605
73942579|NCT00117676|147417573|NON_INFERIORITY_OR_EQUIVALENCE|With a sample size of 200 subjects in the tenofovir DF group and 100 subjects in the adefovir dipivoxil group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the tenofovir DF treatment was inferior to the adefovir dipivoxil treatment (difference in proportions was less than -0.100) in favor of the alternative hypothesis that the tenofovir DF treatment was not inferior.|Difference in proportions|23.5|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|13.2|33.8||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≥ 2 x ULN or \> 2 x ULN) difference is 0.|Z-test|||A two-sided 95% confidence interval (CI), stratified by baseline ALT (≤ 2 x ULN or \> 2 x ULN) was used to evaluate the difference (tenofovir DF - adefovir dipivoxil) in the proportion of complete responders between treatment groups.||33.8|13.2|<0.001
73942580|NCT00117676|147417574|SUPERIORITY_OR_OTHER||Difference in proportions|30.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|21.3|39.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 2 x ULN or \> 2 x ULN).|Z-test|||||39.2|21.3|<0.001
73942581|NCT00117676|147417575|SUPERIORITY_OR_OTHER||Difference in proportions|1.4|STANDARD_ERROR_OF_MEAN|3.4||0.672|TWO_SIDED|95.0|-5.2|8.0||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Two-sided 95% confidence intervals, stratified by baseline ALT (baseline ALT ≤ 2 x ULN, \> 2 x ULN), were used to evaluate treatment arm differences.|Z-test|||||8.0|-5.2|0.672
73942582|NCT00117676|147417580|SUPERIORITY_OR_OTHER||Difference in proportions|5.2|STANDARD_ERROR_OF_MEAN|5.0||0.293|TWO_SIDED|95.0|-4.5|14.9||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Confidence interval stratum adjusted based on baseline ALT (≤ 2 x ULN, \> 2 x ULN).|Z-test|||||14.9|-4.5|0.293
73942583|NCT00117676|147417586|SUPERIORITY_OR_OTHER||Difference in proportions|-0.8|STANDARD_ERROR_OF_MEAN|4.8||0.859|TWO_SIDED|95.0|-10.2|8.5||Statistical tests were not adjusted for baseline ALT stratum. Analysis set included only randomized and treated participants with baseline ALT \> ULN (biochemically evaluable analysis set).|Z-test|P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.||||8.5|-10.2|0.859
73975001|NCT03160885|147495979|SUPERIORITY||Risk Difference (RD)|19.9||||0.084|TWO_SIDED|95.0|-1.2|40.9||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.~P value was considered non-significant"|Cochran-Mantel-Haenszel|This test was not statistically significant and hence next maintenance endpoint in the sequential testing procedure was not evaluated|Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||40.9|-1.2|0.084
73975002|NCT03160885|147495980|SUPERIORITY||Risk Difference (RD)|33.7|||<|0.001|TWO_SIDED|95.0|17.3|50.0||Based on the primary analysis of the primary estimand 'composite'. Subjects who received rescue medication or were transferred to open-label treatment are considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||50.0|17.3|<0.001
73975003|NCT03160885|147495980|SUPERIORITY||Risk Difference (RD)|30.0||||0.001|TWO_SIDED|95.0|13.7|46.4||Test not evaluated for statistical significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||46.4|13.7|0.001
73942584|NCT00117676|147417587|SUPERIORITY_OR_OTHER||Difference in proportions|4.9|STANDARD_ERROR_OF_MEAN|5.3||0.359|TWO_SIDED|95.0|-5.5|15.3||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and confidence interval are stratum adjusted (baseline ALT ≤ 2 x ULN or \> 2 x ULN).||||15.3|-5.5|0.359
73942585|NCT00952822|147417605|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.052||||||90.0|-0.117|0.012||||||||0.012|-0.117|
73942586|NCT00952822|147417606|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.016||||||90.0|-0.076|0.043||||||||0.043|-0.076|
73942587|NCT01250990|147417660|SUPERIORITY_OR_OTHER|||||||0.8||||||p value is for comparison between changes in reverse cholesterol transport in niacin versus placebo groups after 12 weeks of treatment.|t-test, 2 sided|||This is a pilot study to assess the effects of niacin on reverse cholesterol transport. The null hypothesis is that niacin has no effect on reverse cholesterol transport.||||0.8
74089230|NCT01173471|147731491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.57||0.758|TWO_SIDED|95.0|-4.8|3.7|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)|||3.7|-4.8|0.758
74089231|NCT01173471|147731491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.909||0.467|TWO_SIDED|95.0|-2.5|1.2|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)|||1.2|-2.5|0.467
73868999|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.599||||0.2132|TWO_SIDED|95.0|0.16|2.236||1-sided unstratified log-rank test|Log Rank|||Low VEGFR1 expression||2.236|0.160|0.2132
73869000|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.3605|TWO_SIDED|95.0|0.53|1.537||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR1 expression||1.537|0.530|0.3605
73942588|NCT03574597|147417678|SUPERIORITY||Hazard Ratio (HR)|0.8|||<|0.0001|TWO_SIDED|95.0|0.72|0.89|||Regression, Cox|||Data from the in-trial period. The outcome measure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor. Participants without events of interest were censored at the end of their in-trial period.||0.89|0.72|< 0.0001
73942589|NCT06060457|147417719|OTHER||Geometric Mean Ratio (GMR)|0.625|||||TWO_SIDED|95.0|0.57|0.686||||||RSV-A: Arm 1 versus Arm 2||0.686|0.570|
73942590|NCT06060457|147417719|OTHER||GMR|0.638|||||TWO_SIDED|95.0|0.584|0.697||||||RSV-B: Arm 1 versus Arm 2||0.697|0.584|
73942591|NCT02953938|147417775|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_DEVIATION|0.64||0.368|TWO_SIDED|95.0|-1.49|1.07|||Cochran-Mantel-Haenszel|||||1.07|-1.49|0.3680
73942592|NCT02953938|147417776|SUPERIORITY||Mean Difference (Final Values)|-6.58|STANDARD_DEVIATION|3.042||0.0349|TWO_SIDED|95.0|-12.67|-0.48|||ANOVA|||||-0.48|-12.67|0.0349
73942593|NCT02953938|147417777|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.051||0.2707|TWO_SIDED|95.0|-0.045|0.158|||ANOVA|||||0.158|-0.045|0.2707
73942594|NCT02953938|147417779|SUPERIORITY||Mean Difference (Final Values)|11.32||||0.7602|TWO_SIDED|95.0|-62.65|85.28|||ANOVA|||||85.28|-62.65|0.7602
73942595|NCT02038894|147417780|NON_INFERIORITY|A previous study for evaluating respiratory complications with intubated and insufflated techniques found a difference in the incidence of respiratory complications of 9.1%, a power analysis was determined. 200 subjects per group was estimated provide 82% power to detect a difference. We elected to do an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications.|Odds Ratio (OR)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.14||Threshold for significance \<0.05 Comparing SPO2 \<95%|Mean equality test|||||0.14|0|<0.0001
73942596|NCT02038894|147417780|NON_INFERIORITY|A previous study found an incidence of respiratory complications of 9.1%. 200 subjects per group was estimated provide 82% power to detect a difference when conducting a two- sided test at a significance level of a = 0.05.We did an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications. Based on the results of that interim analysis, recruitment was discontinued|Odds Ratio (OR)|0.0||||0.0001|TWO_SIDED|95.0|0.0|0.27||p\<0.05. Sp02\<85%|Mean equality test||Odds ratios were calculated to the respiratory complications comparing the different groups and by regrouping by the differences in airway management (IS + IP vs NA) and by the medication used for anesthesia maintenance (IS vs IP + NA)|||0.27|0|0.0001
73942597|NCT02038894|147417781|NON_INFERIORITY|No previous data was available to calculate a power calculation for the secondary outcome.||||||0.901||||||Threshold of Significance|Mean equality test|||Total OR Time||||0.901
73942598|NCT00313820|147417782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.578||95.0|-0.7|0.4|||ANCOVA|ANCOVA with treatment and country as factors and baseline pain score as covariate.||Modelled Results: Endpoint Mean Pain Score Pregabalin vs Placebo||0.4|-0.7|0.578
73942599|NCT00313820|147417782|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294||95.0||||Interaction p-value based on adding interaction term to the main model.|ANCOVA|||Modelled Results: Treatment by country interaction||||0.294
73942600|NCT00313820|147417783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.161||95.0|-0.8|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1 Modelled Results||0.1|-0.8|0.161
73942601|NCT00313820|147417783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.062||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2 Modelled Results||0.0|-1.0|0.062
73942602|NCT00313820|147417783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.024||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3 Modelled Results||-0.1|-1.1|0.024
73942603|NCT00313820|147417783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.026||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6 Modelled Results||-0.1|-1.1|0.026
73942604|NCT00313820|147417783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.105||95.0|-0.9|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9 Modelled Results||0.1|-0.9|0.105
73942605|NCT00313820|147417783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.592||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12 Modelled Results||0.4|-0.6|0.592
73869001|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921||||0.4438|TWO_SIDED|95.0|0.304|2.784||1-sided unstratified log-rank test|Log Rank|||High VEGFR2 expression||2.784|0.304|0.4438
73942606|NCT00313820|147417784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.087||95.0||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||30% Responders||||0.087
73942607|NCT00313820|147417785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622||95.0||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||50% Responders||||0.622
73942608|NCT00313820|147417786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.027||95.0|-1.0|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1; Modelled Results||-0.1|-1.0|0.027
73942609|NCT00313820|147417786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.038||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2; Modelled Results||-0.0|-1.0|0.038
73942610|NCT00313820|147417786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.004||95.0|-1.2|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3; Modelled Results||-0.2|-1.2|0.004
73942611|NCT00313820|147417786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.005||95.0|-1.1|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6; Modelled Results||-0.2|-1.1|0.005
73942612|NCT00313820|147417786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.078||95.0|-0.9|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9; Modelled Results||0.0|-0.9|0.078
73942613|NCT00313820|147417786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.663||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12; Modelled Results||0.4|-0.6|0.663
73942614|NCT00313820|147417786|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.627||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Endpoint \[Week 12 or ET\]; Modelled Results||0.4|-0.6|0.627
73942615|NCT00313820|147417787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|3.05||0.741||95.0|-7.0|5.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline value as a covariate|ANCOVA|||Modelled Results||5.0|-7.0|0.741
73942616|NCT00313820|147417788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.216||95.0|-1.0|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Burning Pain Week 12 \[LOCF\]; Modelled Results||0.2|-1.0|0.216
73975004|NCT03160885|147495983|SUPERIORITY||Risk Difference (RD)|29.3|||<|0.001|TWO_SIDED|95.0|22.5|36.1||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||36.1|22.5|<0.001
73942617|NCT00313820|147417788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.76||95.0|-0.4|0.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Pressing Pain Week 12 \[LOCF\]; Modelled Results||0.6|-0.4|0.760
73975005|NCT03160885|147495984|SUPERIORITY||Risk Difference (RD)|12.7|||<|0.001|TWO_SIDED|95.0|8.3|17.0||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||17.0|8.3|<0.001
73942618|NCT00313820|147417788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.36||95.0|-0.7|0.3||Estimated from ANCOVA (general linear model) general linear model with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Paroxysmal Pain Week 12 \[LOCF\]; Modelled Results||0.3|-0.7|0.360
73942619|NCT00313820|147417788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.239||95.0|-0.8|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Evoked Pain Week 12 \[LOCF\]; Modelled Results||0.2|-0.8|0.239
73942620|NCT00313820|147417788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.118||95.0|-1.0|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||P/D Week 12 \[LOCF\]; Modelled Results||0.1|-1.0|0.118
73975006|NCT03160885|147495985|SUPERIORITY||Difference of least square means|-9.9|||<|0.001|TWO_SIDED|95.0|-12.2|-7.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change will be imputed as 0.||-7.5|-12.2|<0.001
74091662|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.3|||<|0.001|TWO_SIDED|95.0|1.04|1.64|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 9N. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.64|1.04|<0.001
73942621|NCT00313820|147417788|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|1.87||0.138||95.0|-6.5|0.9||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Total Score Week 12 \[LOCF\]; Modelled Results||0.9|-6.5|0.138
73869002|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.122||||0.5699|TWO_SIDED|95.0|0.403|3.125||1-sided unstratified log-rank test|Log Rank|||Low VEGFR2 expression||3.125|0.403|0.5699
73869003|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.3147|TWO_SIDED|95.0|0.489|1.528||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR2 expression||1.528|0.489|0.3147
73942622|NCT00313820|147417789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|2.79||0.086||95.0|-10.3|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep disturbance; Modelled Results||0.7|-10.3|0.086
73975007|NCT03160885|147495986|SUPERIORITY||Risk Difference (RD)|8.0|||<|0.001|TWO_SIDED|95.0|4.4|11.6||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||11.6|4.4|<0.001
73869004|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.002||||0.5015|TWO_SIDED|95.0|0.281|3.581||1-sided unstratified log-rank test|Log Rank|||High VEGFR3 expression||3.581|0.281|0.5015
73942623|NCT00313820|147417789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.7|STANDARD_ERROR_OF_MEAN|3.72||0.039||95.0|0.4|15.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Snoring score; Modelled Results||15.1|0.4|0.039
73942624|NCT00313820|147417789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|2.71||0.169||95.0|-9.1|1.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Awaken SOB or headache; Modelled Results||1.6|-9.1|0.169
73942625|NCT00313820|147417789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.17||0.03||95.0|0.0|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep quantity; Modelled Results||0.7|0.0|0.030
73942626|NCT00313820|147417789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|3.44||0.013||95.0|1.8|15.4||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep adequacy; Modelled Results||15.4|1.8|0.013
73975008|NCT03160885|147495987|SUPERIORITY||Risk Difference (RD)|18.9|||<|0.001|TWO_SIDED|95.0|12.8|25.1||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference stratified by region and disease severity.|||25.1|12.8|<0.001
73975009|NCT03160885|147495988|SUPERIORITY||Difference of least square means|-1.3|||<|0.001|TWO_SIDED|95.0|-1.7|-0.8||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 1 change will be imputed as 0.||-0.8|-1.7|<0.001
73975010|NCT03160885|147495989|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.001|TWO_SIDED|95.0|13.9|26.2||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||26.2|13.9|<0.001
74031344|NCT02650284|147616155|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.23||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 6-week timepoint.||||0.23
74031345|NCT02650284|147616155|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.1||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 3-month timepoint.||||0.10
73942627|NCT00313820|147417789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.51||0.399||95.0|-2.8|7.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Somnolence; Modelled Results||7.1|-2.8|0.399
74031346|NCT02650284|147616155|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.98||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 12-month timepoint.||||0.98
74091663|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.83|||<|0.001|TWO_SIDED|95.0|1.44|2.32|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 10A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.32|1.44|<0.001
73869005|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.005||||0.4887|TWO_SIDED|95.0|0.334|3.025||1-sided unstratified log-rank test|Log Rank|||Low VEGFR3 expression||3.025|0.334|0.4887
73869006|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.818||||0.2432|TWO_SIDED|95.0|0.473|1.414||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR3 expression||1.414|0.473|0.2432
73869007|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.446||||0.2321|TWO_SIDED|95.0|0.048|4.101||1-sided unstratified log-rank test|Log Rank|||Detected FGF expression||4.101|0.048|0.2321
73869008|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.316||||0.7143|TWO_SIDED|95.0|0.526|3.292||1-sided unstratified log-rank test|Log Rank|||No detected FGF expression||3.292|0.526|0.7143
73869009|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.844||||0.2812|TWO_SIDED|95.0|0.486|1.465||1-sided unstratified log-rank test|Log Rank|||Indeterminate FGF expression||1.465|0.486|0.2812
73942628|NCT00313820|147417789|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.13||0.049||95.0|-8.4|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Overall sleep problems index; Modelled Results||-0.0|-8.4|0.049
73975011|NCT03160885|147495990|SUPERIORITY||Risk Difference (RD)|28.9|||<|0.001|TWO_SIDED|95.0|21.4|36.3||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||36.3|21.4|<0.001
73975012|NCT02307682|147495997|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.98||0.0003|TWO_SIDED|95.0|-2.5|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||1.3|-2.5|0.0003
73975013|NCT02307682|147495997|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-2.1|1.8||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.8|-2.1|<0.0001
73975014|NCT02307682|147495998|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.95||0.0001|TWO_SIDED|95.0|-2.4|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||1.3|-2.4|0.0001
73975015|NCT02307682|147495998|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-1.9|1.9||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.9|-1.9|<0.0001
73975016|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-1.4|0.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||0.9|-1.4|
73975017|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.4|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.1|-1.4|
73975018|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-1.4|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||1.2|-1.4|
73975019|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.7|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||1.2|-1.7|
73975020|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.8|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||1.2|-1.8|
73975021|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||1.6|-1.5|
73975022|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-1.8|1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||1.5|-1.8|
73869010|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.6504|TWO_SIDED|95.0|0.248|7.96||1-sided unstratified log-rank test|Log Rank|||Detected FLT3 expression||7.960|0.248|0.6504
73975023|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-1.1|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||2.1|-1.1|
73869011|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.838||||0.3266|TWO_SIDED|95.0|0.375|1.876||1-sided unstratified log-rank test|Log Rank|||No detected FLT3 expression||1.876|0.375|0.3266
74031347|NCT02650284|147616155|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.5||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 24-month timepoint.||||0.50
74031348|NCT02650284|147616156|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.59||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D Index preoperatively between both groups.||||0.59
73942629|NCT00313820|147417790|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5|STANDARD_ERROR_OF_MEAN|0.5||0.201||95.0|0.8|2.9||Estimated from a logistic regression model with treatment and the baseline assessment as factors.|Regression, Logistic||Standard error of the mean = standard error of the odds ratio.|Modelled Results||2.9|0.8|0.201
73942630|NCT00313820|147417791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.015||95.0|-1.8|-0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 \[LOCF\] Anxiety score; Modelled Results||-0.2|-1.8|0.015
73942631|NCT00313820|147417791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.41||0.6||95.0|-0.6|1.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 \[LOCF\] Depression score; Modelled Results||1.0|-0.6|0.600
73942632|NCT00313820|147417792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.566||95.0|-0.1|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Modelled Results||0.1|-0.1|0.566
73942633|NCT00313820|147417793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.47||0.22||95.0|-1.8|7.9||Estimated from ANCOVA (general linear model) with treatment and coutntry as factors and baseline score as a covariate.|ANCOVA|||Modelled Results||7.9|-1.8|0.220
73942634|NCT00313820|147417794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.144||95.0|-0.5|0.1||Estimated from ANCOVA (general linear model) with treament and country as factors.|ANCOVA|||Modelled Results||0.1|-0.5|0.144
73942635|NCT00313820|147417795|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.049||95.0|-0.6|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors.|ANCOVA|||Modelled Results||-0.0|-0.6|0.049
73942636|NCT01224925|147417874|SUPERIORITY||Log Rank (Mantel-Cox)|842.0|||<|0.01|TWO_SIDED|95.0|693.0|991.0|||Log Rank|||The power calculation was based on the intention to show a 30% difference in success rates. The following parameters were used (binomial scale): type I error: 5%; expected success rate in the CH group: 55% (based on Barthel et al. 2000); minimal difference between success rates not to be overlooked: 30%; type II error: 5%. The calculations revealed the need for 64 subjects in each group. After adding 20% for eventual drop-outs, we planned to recruit 160 subjects in one year.||991|693|<0.01
73942637|NCT01224925|147417874|SUPERIORITY||Log Rank (Mantel-Cox)|1201.0|||<|0.01|TWO_SIDED|95.0|1068.0|1335.0|||Log Rank|||||1335|1068|<0.01
73942638|NCT01224925|147417875|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
73942639|NCT03315143|147417885|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.63|0.88|||Cox proportional hazards model|||The estimates of the hazard ratio (HR) and corresponding 2-sided 95% confidence interval (CI) was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-cardiovascular (non-CV) death treated as a competing event.||0.88|0.63|<0.001
73942640|NCT03315143|147417886|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.55|0.82|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.82|0.55|<0.001
73942641|NCT03315143|147417887|SUPERIORITY||Hazard Ratio (HR)|0.9|||=|0.35|TWO_SIDED|95.0|0.73|1.12|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.12|0.73|=0.35
74031349|NCT02650284|147616156|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.9||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 3-months between both groups.||||0.90
73869012|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.3597|TWO_SIDED|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate FLT3 expression||1.598|0.502|0.3597
73869013|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.342||||0.6907|TWO_SIDED|95.0|0.419|4.297||1-sided unstratified log-rank test|Log Rank|||Detected KIT expression||4.297|0.419|0.6907
73869014|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.199|TWO_SIDED|95.0|0.265|1.731||1-sided unstratified log-rank test|Log Rank|||Participants with no detected KIT expression||1.731|0.265|0.1990
73942642|NCT03315143|147417888|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.63|0.83||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.83|0.63|
73942643|NCT03315143|147417889|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.89|0.65|
73942644|NCT03315143|147417890|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.46|1.08||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.08|0.46|
73942645|NCT03315143|147417891|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.83|1.18||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction.||1.18|0.83|
73942646|NCT03315143|147417892|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.91|0.65|
73942647|NCT04067401|147417933|SUPERIORITY||Effect size|-0.13||||0.062|TWO_SIDED|95.0|-0.29|0.01|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.01|-.29|.062
73942648|NCT04067401|147417934|SUPERIORITY||Effect size|-0.23||||0.001|TWO_SIDED|95.0|-0.39|-0.09|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.09|-.39|.001
73942649|NCT04067401|147417935|SUPERIORITY||Effect size|-0.16||||0.027|TWO_SIDED|95.0|-0.34|-0.02|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.02|-.34|.027
73942650|NCT04067401|147417936|SUPERIORITY||Effect size|-0.24||||0.002|TWO_SIDED|95.0|-0.41|-0.08|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.08|-.41|.002
73942651|NCT04067401|147417937|SUPERIORITY||Effect size|0.01||||0.821|TWO_SIDED|95.0|-0.12|0.11|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.11|-.12|.821
73942652|NCT04067401|147417938|SUPERIORITY||Effect size|-0.14||||0.024|TWO_SIDED|95.0|-0.31|-0.02|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.02|-.31|.024
73942653|NCT04067401|147417939|SUPERIORITY||Effect size|0.18||||0.012|TWO_SIDED|95.0|0.04|0.29|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.29|.04|.012
73942654|NCT04067401|147417940|SUPERIORITY||Effect size|0.21||||0.01|TWO_SIDED|95.0|0.05|0.35||Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component|Mixed Models Analysis|||||.35|.05|.010
73942655|NCT03086330|147418020|OTHER||Treatment difference|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.24|||ANCOVA|||The responses were analysed using an analysis of covariance (ANCOVA) with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.||-1.24|-1.61|<0.0001
73942656|NCT03086330|147418021|OTHER||Treatment difference|-3.81|||<|0.0001|TWO_SIDED|95.0|-4.7|-2.93|||ANCOVA|||The responses were analysed using an ANCOVA with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.||-2.93|-4.70|<0.0001
74031350|NCT02650284|147616156|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 12-months between both groups.||||0.57
74031351|NCT02650284|147616156|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.49||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 24-months between both groups.||||0.49
74031352|NCT02650284|147616156|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means||||||0.65||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS preoperatively between both groups.||||0.65
74031353|NCT02650284|147616156|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.3||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 3-months between both groups.||||0.30
74031354|NCT02650284|147616156|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.06||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 12-months between both groups.||||0.06
73942657|NCT01814748|147418096|SUPERIORITY_OR_OTHER||Difference in least squares means|0.12||||0.535|TWO_SIDED|95.0|-0.26|0.49|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||0.49|-0.26|0.535
73942658|NCT01814748|147418097|SUPERIORITY_OR_OTHER||Difference in percent|-0.4|||||TWO_SIDED|95.0|-13.8|13.0||||||||13.0|-13.8|
73942659|NCT01814748|147418098|SUPERIORITY_OR_OTHER||Difference in percent|-2.0||||||||||||||||||
73942660|NCT01814748|147418099|SUPERIORITY_OR_OTHER||Difference in least squares means|4.2||||0.685|TWO_SIDED|95.0|-16.1|24.4|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||24.4|-16.1|0.685
73942661|NCT01814748|147418100|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.7||||0.586|TWO_SIDED|95.0|-17.1|9.7|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||9.7|-17.1|0.586
73942662|NCT01814748|147418101|SUPERIORITY_OR_OTHER||Between-group rate difference|-0.4|||||TWO_SIDED|95.0|-14.0|13.1|||Mietinnen and Nurminen|||||13.1|-14.0|
73942663|NCT01814748|147418102|SUPERIORITY_OR_OTHER||Between-group rate difference|4.0|||||TWO_SIDED|95.0|-7.4|15.5|||Mietinnen and Nurminen|||||15.5|-7.4|
73942664|NCT01972529|147418108|SUPERIORITY||Difference of proportion vs placebo|42.6|||<|0.0001|TWO_SIDED|95.0|27.2|58.1|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion versus (vs) placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||58.1|27.2|<0.0001
73942665|NCT01972529|147418108|SUPERIORITY||Difference of proportion vs placebo|49.9|||<|0.0001|TWO_SIDED|95.0|31.6|68.2|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.||68.2|31.6|<0.0001
73942666|NCT01972529|147418109|SUPERIORITY||Difference of proportion vs placebo|64.7|||<|0.0001|TWO_SIDED|95.0|53.6|75.8|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||75.8|53.6|<0.0001
73942667|NCT01972529|147418109|SUPERIORITY||Difference of percentage vs placebo|67.5|||<|0.0001|TWO_SIDED|95.0|51.6|83.4|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||83.4|51.6|<0.0001
73942668|NCT01972529|147418110|SUPERIORITY||Difference in change of platelet count|27.5|||<|0.0001|TWO_SIDED|95.0|22.5|32.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||32.5|22.5|<0.0001
73942669|NCT01972529|147418110|SUPERIORITY||Difference in change of platelet count|33.0|||<|0.0001|TWO_SIDED|95.0|25.5|41.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||41.5|25.5|<0.0001
73942670|NCT02274857|147418113|SUPERIORITY|||||||0.2179|||||||Chi-squared|||||||0.2179
73942671|NCT02274857|147418114|SUPERIORITY|||||||0.2782|||||||Chi-squared|||||||0.2782
73942672|NCT02274857|147418115|SUPERIORITY|||||||0.7266|||||||Chi-squared|||||||0.7266
73942673|NCT02274857|147418116|SUPERIORITY|||||||0.3522|||||||Chi-squared|||||||0.3522
73942674|NCT00330174|147418120|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Mixed Models Analysis|||Drinking outcomes were analyzed using multiple linear regression, controlling for site and baseline drinking level. Drinking and psychiatric symptoms assessed over time were examined using repeated measures (intercept only) mixed linear models (PROC MIXED in SAS). Analyses were performed using SAS statistical software (version 9.2; SAS Institute, Inc., Cary, NC). All tests were two-tailed and p-values less than 0.05 were considered statistically significant.||||0.64
73942675|NCT01058304|147418233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67||||0.1024|TWO_SIDED|95.0|-5.87|0.538|||Mixed Models Analysis|||"The analysis compares study Arm 1 and Arm 2 at 24-week follow-up, with 12-week data also included in the response trajectory.~The hypothesis being tested is that group-based PT (Arm 1) will result in a significantly greater improvement WOMAC scores compared to individual PT (Arm 2)"||0.538|-5.87|0.1024
73942676|NCT01058304|147418233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.444|TWO_SIDED|95.0|-4.64|2.04|||Mixed Models Analysis|||The hypothesis being tested is that the group-based PT program (Arm 1) will result in greater improvements in WOMAC scores at 24-week follow-up (12 weeks after the end of the group program) when compared to usual PT care (Arm 2).||2.04|-4.64|0.444
73942677|NCT01058304|147418234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113||||0.527|TWO_SIDED|95.0|-0.463|0.238|||Mixed Models Analysis|||The analysis compares Arms 1 and 2 at 12-week follow-up. The hypothesis being tested is that the group-based PT program (Arm 1) will result in a significantly greater improvement in SPPB scores compared with the individual PT program (Arm 2).||0.238|-0.463|0.527
73942678|NCT02755597|147418236|SUPERIORITY||Hazard Ratio (HR)|0.656|||=|0.012|TWO_SIDED|95.0|0.471|0.913|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.913|0.471|=0.012
73942679|NCT02755597|147418237|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||<0.001
73942680|NCT02755597|147418239|SUPERIORITY||Hazard Ratio (HR)|0.508|||<|0.001|TWO_SIDED|95.0|0.343|0.753|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.753|0.343|<0.001
73869015|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.3597|TWO_SIDED|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate KIT expression||1.598|0.502|0.3597
73869016|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.693||||0.3757|TWO_SIDED|95.0|0.071|6.765||1-sided unstratified log-rank test|Log Rank|||Detected RET expression||6.765|0.071|0.3757
73942681|NCT02755597|147418244|SUPERIORITY||Hazard Ratio (HR)|1.191|||=|0.385|TWO_SIDED|95.0|0.802|1.77|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||1.770|0.802|=0.385
73942682|NCT02755597|147418245|SUPERIORITY||Hazard Ratio (HR)|0.571|||=|0.001|TWO_SIDED|95.0|0.405|0.805|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.805|0.405|=0.001
73942683|NCT02755597|147418246|SUPERIORITY||||||=|0.019|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||=0.019
73942684|NCT02755597|147418247|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||<0.001
73942685|NCT01069354|147418248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.41|||<|0.0001|TWO_SIDED|||||Paired t-test|t-test, 2 sided|||||||<0.0001
73942686|NCT01069354|147418249|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Binomial proportion, two-sided Fisher's exact test|Fisher Exact|||91 (90.1%) of 101 subjects had a ≥ 2.0 cm lower VAS Score in treatment versus control NLF at Time 0||||<0.0001
73942687|NCT01069354|147418250|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
73942688|NCT01069354|147418251|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
73942689|NCT01069354|147418252|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
73942690|NCT01069354|147418253|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
73942691|NCT01069354|147418254|SUPERIORITY_OR_OTHER|||||||0.5663||||||Paired t-test|t-test, 2 sided|||||||0.5663
73942692|NCT01069354|147418255|SUPERIORITY_OR_OTHER|||||||0.3197||||||Paired t-test|t-test, 2 sided|||||||0.3197
73942693|NCT01895972|147418298|OTHER||||||<|0.001||||||The reduction from baseline in IOP was significant at all post-baseline assessment time points through Week 52.|t-test, 2 sided|||comparison vs. baseline||||<0.001
73942694|NCT01800968|147418327|SUPERIORITY_OR_OTHER|||||||0.3087|||||||Rank score|||||||0.3087
73942695|NCT01800968|147418328|SUPERIORITY_OR_OTHER|||||||0.1549|||||||Regression, Linear|||||||0.1549
73942696|NCT01800968|147418329|SUPERIORITY_OR_OTHER|||||||0.1932|||||||Regression, Linear|||||||0.1932
73942697|NCT01800968|147418330|SUPERIORITY_OR_OTHER|||||||0.9535|||||||Regression, Linear|||||||0.9535
73942698|NCT01800968|147418331|SUPERIORITY_OR_OTHER|||||||0.8548|||||||Regression, Linear|||||||0.8548
73942699|NCT01800968|147418332|SUPERIORITY_OR_OTHER|||||||0.4266|||||||Regression, Linear|||||||0.4266
73942700|NCT01800968|147418333|SUPERIORITY_OR_OTHER|||||||0.1705|||||||Regression, Linear|||||||0.1705
73942701|NCT01800968|147418334|SUPERIORITY_OR_OTHER|||||||0.1309|||||||Regression, Linear|||||||0.1309
73942702|NCT01800968|147418335|SUPERIORITY_OR_OTHER|||||||0.792|||||||Regression, Linear|||||||0.7920
73942703|NCT01800968|147418336|SUPERIORITY_OR_OTHER|||||||0.7026|||||||Regression, Linear|||||||0.7026
73942704|NCT01800968|147418337|SUPERIORITY_OR_OTHER|||||||0.2662|||||||Regression, Linear|||||||0.2662
73942705|NCT01800968|147418338|SUPERIORITY_OR_OTHER|||||||0.6395|||||||Regression, Linear|||||||0.6395
73942706|NCT01800968|147418339|SUPERIORITY_OR_OTHER|||||||0.8218|||||||Regression, Linear|||||||0.8218
73942707|NCT01800968|147418340|SUPERIORITY_OR_OTHER|||||||0.1124|||||||Regression, Linear|||||||0.1124
73942708|NCT01800968|147418341|SUPERIORITY_OR_OTHER|||||||0.8088|||||||Regression, Linear|||||||0.8088
73942709|NCT01800968|147418342|SUPERIORITY_OR_OTHER|||||||0.7764|||||||Log Rank|||||||0.7764
73942710|NCT01800968|147418343|SUPERIORITY_OR_OTHER|||||||0.1701|||||||Log Rank|||||||0.1701
73942711|NCT01800968|147418344|SUPERIORITY_OR_OTHER|||||||0.6532|||||||Regression, Linear|||||||0.6532
73942712|NCT01800968|147418345|SUPERIORITY_OR_OTHER|||||||0.2033|||||||Rank score|||||||0.2033
73975024|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-2.2|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||1.0|-2.2|
73975025|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.2|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||1.2|-2.2|
73942713|NCT01422408|147418369|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.|||||<|0.001||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.||||<0.001
73942714|NCT01422408|147418369|OTHER|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.001|TWO_SIDED|95.0|0.0|0.36||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equation) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"||0.36|0|0.001
73942715|NCT01422408|147418370|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.002||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.||||0.002
73975026|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-2.1|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||1.3|-2.1|
73975027|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-1.9|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||1.6|-1.9|
73975028|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||1.7|-1.9|
73975029|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.4|2.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||2.2|-1.4|
73975030|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-2.4|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||1.3|-2.4|
73975031|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-1.2|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||2.5|-1.2|
73975032|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-2.9|0.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||0.8|-2.9|
73975033|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-2.1|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||1.6|-2.1|
73975034|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.2|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||1.6|-2.2|
73975035|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.9|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||2.1|-1.9|
73869017|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.3723|TWO_SIDED|95.0|0.358|2.13||1-sided unstratified log-rank test|Log Rank|||No detected RET expression||2.130|0.358|0.3723
73975036|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.1|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||1.9|-2.1|
73975037|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.8|2.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||2.2|-1.8|
73975038|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.5|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||1.3|-2.5|
73975039|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.1|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.8|-2.1|
73975040|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.2|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||1.8|-2.2|
73975041|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||1.9|-2.2|
73975042|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.5|1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||1.5|-2.5|
74031355|NCT02650284|147616156|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.44||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 24-months between both groups.||||0.44
73869018|NCT00265317|147282581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.3263|TWO_SIDED|95.0|0.501|1.523||1-sided unstratified log-rank test|Log Rank|||Indeterminate RET expression||1.523|0.501|0.3263
73869019|NCT00265317|147282582|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 2, Day 1||||<0.0001
73942716|NCT01422408|147418370|OTHER|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.062|TWO_SIDED|95.0|0.0|1.09||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equations) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"||1.09|0|0.062
73942717|NCT01422408|147418371|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.||||0.001
73942718|NCT01422408|147418372|OTHER|2.5% significance level to account for two co-primary endpoints.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.||||0.002
73942719|NCT01422408|147418374|OTHER|||||||0.1029||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.1029
73942720|NCT01422408|147418375|OTHER|||||||0.2678||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2678
73942721|NCT01422408|147418376|OTHER|||||||0.2472||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2472
73942722|NCT01422408|147418377|OTHER|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.507
73942723|NCT01422408|147418378|OTHER|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.3676
73942724|NCT01422408|147418379|OTHER|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6023
73942725|NCT01422408|147418380|OTHER|||||||0.6587||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6587
73942726|NCT01422408|147418381|OTHER|||||||0.8772||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.8772
73942727|NCT01422408|147418382|OTHER|||||||0.7395||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.7395
73942728|NCT01422408|147418383|OTHER|||||||0.9618||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.9618
73942729|NCT01422408|147418384|OTHER|||||||0.5113||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.5113
73942730|NCT01422408|147418385|OTHER|||||||0.8833||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.8833
73942731|NCT01422408|147418386|OTHER|||||||0.7983||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.7983
73942732|NCT01422408|147418387|OTHER|||||||0.4937||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.4937
73975043|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.7|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||1.4|-2.7|
73975044|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.1|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||1.9|-2.1|
73975045|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||1.9|-2.2|
73869020|NCT00265317|147282582|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 3, Day 1||||<0.0001
73942733|NCT01422408|147418388|OTHER|||||||0.9106||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.9106
73942734|NCT01422408|147418389|OTHER|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.507
73942735|NCT01422408|147418390|OTHER|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.3676
73975046|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.3|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||1.7|-2.3|
73975047|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||1.9|-2.2|
73975048|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.1|2.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||2.0|-2.1|
73975049|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||1.9|-2.2|
73869021|NCT00265317|147282584|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 2, Day 1||||<0.0001
73942736|NCT01422408|147418391|OTHER|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6023
73942737|NCT01422408|147418392|OTHER|||||||0.08531||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.08531
73942738|NCT01422408|147418393|OTHER|||||||0.2011||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2011
73942739|NCT01422408|147418394|OTHER|||||||0.1187||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.1187
73942740|NCT03266770|147418420|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.83|TWO_SIDED|95.0|-1.07|1.29|||t-test, 2 sided|||||1.29|-1.07|0.83
73942741|NCT05007392|147418427|SUPERIORITY||Difference of percentage|35.87|||<|0.001|TWO_SIDED|95.0|27.36|44.37|||Cochran-Mantel-Haenszel|P value based on a Cochran-Mantel-Haenszel test stratified by baseline SUA level and baseline body mass index (BMI) level.|The difference of percentage and stratified 95 percent (%) confidence interval (CI) was based on Mantel-Haenszel method.|||44.37|27.36|<0.001
73942742|NCT05007392|147418428|NON_INFERIORITY|The prespecified non-inferiority margin was -10% in the analysis.|Difference of percentage|5.24|||||TWO_SIDED|95.0|-3.69|14.17|||||The difference of percentage and stratified 95% CI was based on Mantel-Haenszel method.|||14.17|-3.69|
73975050|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-2.0|2.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||2.3|-2.0|
73975051|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-2.4|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.8|-2.4|
73869022|NCT00265317|147282584|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 3, Day 1||||<0.0001
73942743|NCT01218126|147418433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.517|TWO_SIDED|95.0|-10.4|5.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4.||5.2|-10.4|0.517
73942744|NCT01218126|147418433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.763|TWO_SIDED|95.0|-8.9|6.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||6.5|-8.9|0.763
73942745|NCT01218126|147418433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.5||||0.164|TWO_SIDED|95.0|-2.3|13.3|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||13.3|-2.3|0.164
73942746|NCT01218126|147418433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.9|TWO_SIDED|95.0|-9.2|10.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||10.5|-9.2|0.900
73942747|NCT01218126|147418433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.788|TWO_SIDED|95.0|-11.1|8.4|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||8.4|-11.1|0.788
73942748|NCT01218126|147418433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.722|TWO_SIDED|95.0|-8.2|11.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||11.8|-8.2|0.722
73975052|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-1.8|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||2.4|-1.8|
73869023|NCT00265317|147282589|SUPERIORITY_OR_OTHER|||||||0.3681||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.3681
73869024|NCT00265317|147282590|SUPERIORITY_OR_OTHER|||||||0.5982||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.5982
73869025|NCT00265317|147282591|SUPERIORITY_OR_OTHER|||||||0.9807||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.9807
73869026|NCT00265317|147282592|SUPERIORITY_OR_OTHER|||||||0.3945||||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.3945
73942749|NCT01218126|147418433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7||||0.26|TWO_SIDED|95.0|-18.2|4.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||4.9|-18.2|0.260
73942750|NCT01218126|147418433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.422|TWO_SIDED|95.0|-16.1|6.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||6.8|-16.1|0.422
73942751|NCT01218126|147418433|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4||||0.564|TWO_SIDED|95.0|-15.1|8.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||8.2|-15.1|0.564
73942752|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.968|TWO_SIDED|95.0|-39.0|38.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 4||38|-39|0.968
73942753|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0||||0.715|TWO_SIDED|95.0|-45.0|31.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 Placebo versus Losmapimod 7.5 mg at Week 4||31|-45|0.715
73942754|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0||||0.152|TWO_SIDED|95.0|-10.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4||66|-10|0.152
73975053|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-2.1|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||2.1|-2.1|
73942755|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.922|TWO_SIDED|95.0|-45.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8||40|-45|0.922
73942756|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.694|TWO_SIDED|95.0|-34.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8||50|-34|0.694
73942757|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.0||||0.094|TWO_SIDED|95.0|-6.3|79.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8||79|-6.3|0.094
73975054|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-1.5|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||2.7|-1.5|
73942758|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.456|TWO_SIDED|95.0|-26.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12||58|-26|0.456
73942759|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.355|TWO_SIDED|95.0|-22.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12||61|-22|0.355
73942760|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0||||0.023|TWO_SIDED|95.0|6.7|91.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12||91|6.7|0.023
73942761|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.0||||0.32|TWO_SIDED|95.0|-21.0|65.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16||65|-21|0.320
73942762|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.0||||0.267|TWO_SIDED|95.0|-19.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16||67|-19|0.267
73942763|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.0||||0.289|TWO_SIDED|95.0|-20.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16||67|-20|0.289
73942764|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.786|TWO_SIDED|95.0|-37.0|49.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20||49|-37|0.786
73942765|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.0||||0.134|TWO_SIDED|95.0|-10.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20||76|-10|0.134
73942766|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|29.0||||0.191|TWO_SIDED|95.0|-15.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20||74|-15|0.191
73942767|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.852|TWO_SIDED|95.0|-38.0|46.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24||46|-38|0.852
73942768|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0||||0.397|TWO_SIDED|95.0|-24.0|60.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24||60|-24|0.397
73942769|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0||||0.494|TWO_SIDED|95.0|-28.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24||58|-28|0.494
73942770|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.807|TWO_SIDED|95.0|-31.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4||40|-31|0.807
73942771|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.386|TWO_SIDED|95.0|-20.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4||51|-20|0.386
73942772|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.0||||0.089|TWO_SIDED|95.0|-4.8|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4||67|-4.8|0.089
73942773|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.958|TWO_SIDED|95.0|-45.0|43.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8||43|-45|0.958
73942774|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0||||0.766|TWO_SIDED|95.0|-37.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8||50|-37|0.766
73942775|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.0||||0.06||95.0|-1.7|87.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8||87|-1.7|0.060
73942776|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.678|TWO_SIDED|95.0|-53.0|35.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12||35|-53|0.678
73942777|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.0||||0.636|TWO_SIDED|95.0|-33.0|54.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12||54|-33|0.636
73942778|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0||||0.094|TWO_SIDED|95.0|-6.5|83.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12||83|-6.5|0.094
73942779|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.0||||0.772|TWO_SIDED|95.0|-49.0|37.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16||37|-49|0.772
73942780|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.0||||0.387|TWO_SIDED|95.0|-24.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16||61|-24|0.387
73942781|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.0||||0.243|TWO_SIDED|95.0|-18.0|69.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16||69|-18|0.243
73942782|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.0||||0.398|TWO_SIDED|95.0|-62.0|25.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20||25|-62|0.398
73942783|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.0||||0.214|TWO_SIDED|95.0|-16.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20||70|-16|0.214
73869027|NCT02510001|147282593|OTHER||||||||||||||||||"The primary dose escalation analysis was to find the MTD, which was defined as the dose of PF-02341066 in combination with PD-0325901 at which no more than one out of six patients experience a DLT (dose limiting toxicity). The DLT was based on observed toxicity in cycle 1, and was defined as an almost certainly or probably drug-related adverse event to PF-02341066 and/or PD-0325901.~The MTD for the PD 0325901/PF-02341066 combination was 8mg BD(days1-21) and 200mg BD continuously in a 28 day cycle (Dose Level 4)."|||
73869028|NCT02510001|147282595|OTHER|||||||||||||||||The primary dose escalation analysis was to find the MTD, which was defined as the dose of PF-02341066 in combination with Binimetinib at which no more than one out of six patients experience a DLT (dose limiting toxicity). The DLT was based on observed toxicity in cycle 1, and was defined as an almost certainly or probably drug-related adverse event to PF-02341066 and/or Binimetinib.|"Binimetinib 30mg BD on days 1 - 21 every 28 days with Crizotinib 250 mg OD continuously is the MTD, the recommended dose and schedule for further evaluation in our and other trials.~This was as only one DLT was experienced in 6 evaluable patients at this final dose escalation level."|||
73942784|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.0||||0.526|TWO_SIDED|95.0|-30.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20||58|-30|0.526
73942785|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.671|TWO_SIDED|95.0|-53.0|34.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24||34|-53|0.671
73975055|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.4|2.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||2.8|-1.4|
73975056|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.5|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||2.7|-1.5|
73975057|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-1.8|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||2.4|-1.8|
73975058|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.8|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||2.5|-1.8|
73869029|NCT00711971|147282636|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||Significance for the BDI test at 26-28 weeks||||.29
73869030|NCT00711971|147282636|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||Significance for BDI at 34-36 weeks gestation||||.51
73942786|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.355|TWO_SIDED|95.0|-23.0|64.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24||64|-23|0.355
73975059|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.9|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||2.4|-1.9|
73975060|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.9|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||2.5|-1.9|
73869031|NCT00711971|147282636|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||BDI score at 6-8 weeks postpartum||||.56
73869032|NCT00711971|147282637|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Gestational diabetes mellitus||||.06
73869033|NCT00711971|147282637|SUPERIORITY_OR_OTHER|||||||0.12|||||||Fisher Exact|||Hypertension or preeclampsia||||.12
73869034|NCT00711971|147282637|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||Induced labor||||.20
73869035|NCT00711971|147282637|SUPERIORITY_OR_OTHER|||||||0.08|||||||Fisher Exact|||Cesarean section||||.08
73869036|NCT00711971|147282637|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||Spontaneous vaginal delivery||||.88
73869037|NCT00711971|147282637|SUPERIORITY_OR_OTHER|||||||0.32|||||||Fisher Exact|||Operative vaginal delivery||||.32
73869038|NCT00711971|147282638|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
73869039|NCT00711971|147282639|SUPERIORITY_OR_OTHER|||||||0.81|||||||ANOVA|||||||.81
73975061|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-1.8|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||2.5|-1.8|
73869040|NCT00711971|147282640|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Kruskal-Wallis test was used for outliers; Tukey multiple comparisons test was also used.||||||<.001
73869041|NCT00711971|147282641|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANOVA|||||||.39
73942787|NCT01218126|147418434|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.781|TWO_SIDED|95.0|-38.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24||50|-38|0.781
73942788|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.742|TWO_SIDED|95.0|-66.0|93.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4||93|-66|0.742
73942789|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.0||||0.446|TWO_SIDED|95.0|-109.0|48.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4||48|-109|0.446
73942790|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.0||||0.157|TWO_SIDED|95.0|-22.0|137.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4||137|-22|0.157
73975062|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-1.9|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||2.5|-1.9|
73975063|NCT02307682|147496003|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.6|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||2.7|-1.6|
73975064|NCT02307682|147496004|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.9|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48||1.1|-1.9|
73975065|NCT02307682|147496004|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||1.6|-1.5|
73942791|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.826|TWO_SIDED|95.0|-93.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8||74|-93|0.826
73942792|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.773||95.0|-95.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8||70|-95|0.773
73942793|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|47.0||||0.277|TWO_SIDED|95.0|-38.0|131.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8||131|-38|0.277
73975066|NCT02307682|147496004|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-1.8|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96||1.6|-1.8|
73975067|NCT02307682|147496004|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-1.7|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||1.8|-1.7|
74031356|NCT02650284|147616157|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.97||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest preoperatively between both groups.||||0.97
73869042|NCT00711971|147282642|SUPERIORITY_OR_OTHER|||||||0.19|||||||ANOVA|||||||.19
73869043|NCT00711971|147282643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
73869044|NCT00711971|147282644|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANOVA|||||||0.54
73869045|NCT05274269|147282704|SUPERIORITY||LS Mean difference|9.2|||<|0.0001|TWO_SIDED|95.0|7.2|11.3|||Mixed Models for Repeated Measures|||||11.3|7.2|< 0.0001
73869046|NCT05274269|147282705|SUPERIORITY||LS Mean difference|-28.3|||<|0.0001|TWO_SIDED|95.0|-32.1|-24.5|||Mixed Models for Repeated Measures|||||-24.5|-32.1|< 0.0001
73869047|NCT05274269|147282706|SUPERIORITY||LS Mean difference|19.5|||<|0.0001|TWO_SIDED|95.0|15.5|23.5|||Mixed Models for Repeated Measures|||||23.5|15.5|< 0.0001
73869048|NCT05274269|147282707|SUPERIORITY||LS Mean difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.24|0.69|||Mixed Models for Repeated Measures|||||0.69|0.24|< 0.0001
73869049|NCT05274269|147282708|SUPERIORITY||LS Mean difference|1.3|||<|0.0001|TWO_SIDED|95.0|0.6|1.9|||Mixed Models for Repeated Measures|||||1.9|0.6|< 0.0001
73869050|NCT00709618|147282735|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||||TWO_SIDED|95.0|26.4|55.4|||||The estimated value respresents the percentage of participants with a complete response or a partial response.|||55.4|26.4|
73942794|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.0||||0.319|TWO_SIDED|95.0|-43.0|132.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12||132|-43|0.319
73942795|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.716|TWO_SIDED|95.0|-71.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12||103|-71|0.716
73942796|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|75.0||||0.098|TWO_SIDED|95.0|-14.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12||163|-14|0.098
73942797|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.0||||0.832|TWO_SIDED|95.0|-80.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16||100|-80|0.832
73942798|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.0||||0.579|TWO_SIDED|95.0|-64.0|114.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16||114|-64|0.579
73942799|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|42.0||||0.369|TWO_SIDED|95.0|-49.0|133.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16||133|-49|0.369
73942800|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.0||||0.487|TWO_SIDED|95.0|-121.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20||58|-121|0.487
73942801|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.887|TWO_SIDED|95.0|-82.0|95.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20||95|-82|0.887
73942802|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.0||||0.486|TWO_SIDED|95.0|-59.0|123.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20||123|-59|0.486
73942803|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.0||||0.604||95.0|-113.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24||66|-113|0.604
73942804|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0||||0.872|TWO_SIDED|95.0|-97.0|82.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24||82|-97|0.872
73942805|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.0||||0.355|TWO_SIDED|95.0|-48.0|134.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24||134|-48|0.355
73942806|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.839|TWO_SIDED|95.0|-65.0|80.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4||80|-65|0.839
73942807|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.0||||0.741|TWO_SIDED|95.0|-60.0|84.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4||84|-60|0.741
73942808|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|71.0||||0.056|TWO_SIDED|95.0|-1.8|143.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4||143|-1.8|0.056
73942809|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.0||||0.554|TWO_SIDED|95.0|-107.0|57.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8||57|-107|0.554
73942810|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.0||||0.472|TWO_SIDED|95.0|-110.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8||51|-110|0.472
73942811|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.0||||0.116|TWO_SIDED|95.0|-16.0|149.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8||149|-16|0.116
73942812|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0||||0.805|TWO_SIDED|95.0|-98.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12||76|-98|0.805
73942813|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.763|TWO_SIDED|95.0|-73.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12||100|-73|0.763
73942814|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|75.0||||0.096|TWO_SIDED|95.0|-13.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12||163|-13|0.096
73942815|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0||||0.485|TWO_SIDED|95.0|-118.0|56.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16||56|-118|0.485
73942816|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.0||||0.704|TWO_SIDED|95.0|-69.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16||103|-69|0.704
73942817|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|72.0||||0.108|TWO_SIDED|95.0|-16.0|159.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16||159|-16|0.108
73942818|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-64.0||||0.147||95.0|-151.0|23.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20||23|-151|0.147
73942819|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.792|TWO_SIDED|95.0|-98.0|75.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20||75|-98|0.792
73942820|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.0||||0.275||95.0|-39.0|138.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20||138|-39|0.275
73942821|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.0||||0.53|TWO_SIDED|95.0|-115.0|59.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24||59|-115|0.530
73942822|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.0||||0.827|TWO_SIDED|95.0|-77.0|96.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24||96|-77|0.827
73942823|NCT01218126|147418435|SUPERIORITY_OR_OTHER||Mean Difference (Net)|35.0||||0.434|TWO_SIDED|95.0|-53.0|124.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24||124|-53|0.434
73942824|NCT01218126|147418436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.686|TWO_SIDED|95.0|-3.3|2.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||2.2|-3.3|0.686
73942825|NCT01218126|147418436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5||||0.279|TWO_SIDED|95.0|-1.2|4.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||4.2|-1.2|0.279
73942826|NCT01218126|147418436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.193|TWO_SIDED|95.0|-4.6|0.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.9|-4.6|0.193
73942827|NCT01218126|147418436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.803|TWO_SIDED|95.0|-2.7|3.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||3.5|-2.7|0.803
73942828|NCT01218126|147418436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.229|TWO_SIDED|95.0|-1.2|5.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||5.0|-1.2|0.229
73942829|NCT01218126|147418436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.39|TWO_SIDED|95.0|-4.5|1.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.8|-4.5|0.390
73942830|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96||||0.157|TWO_SIDED|95.0|0.91|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4||1.01|0.91|0.157
73942831|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0|TWO_SIDED|95.0|0.86|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||0.95|0.86|0.000
73942832|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0|TWO_SIDED|95.0|0.86|0.96|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||0.96|0.86|0.000
73942833|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.072||95.0|0.9|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8||1.00|0.90|0.072
73942834|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0|TWO_SIDED|95.0|0.85|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.95|0.85|0.000
73942835|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88||||0|TWO_SIDED|95.0|0.83|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 8||0.94|0.83|0.000
73942836|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.728|TWO_SIDED|95.0|0.93|1.05|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||1.05|0.93|0.728
73942837|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.002|TWO_SIDED|95.0|0.86|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||0.97|0.86|0.002
73942838|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.001|TWO_SIDED|95.0|0.84|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.95|0.84|0.001
73942839|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.01||||0.823|TWO_SIDED|95.0|0.95|1.07|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||1.07|0.95|0.823
73942840|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96||||0.153|TWO_SIDED|95.0|0.9|1.02|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||1.02|0.90|0.153
73942841|NCT01218126|147418438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.126|TWO_SIDED|95.0|0.9|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.01|0.90|0.126
74031357|NCT02650284|147616157|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.45||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 3-months between both groups.||||0.45
73942842|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.87||||0.291|TWO_SIDED|95.0|0.68|1.12|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4||1.12|0.68|0.291
73942843|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78||||0.046|TWO_SIDED|95.0|0.61|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||1.00|0.61|0.046
73942844|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.014|TWO_SIDED|95.0|0.57|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||0.94|0.57|0.014
73942845|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.04||||0.755|TWO_SIDED|95.0|0.82|1.32|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8||1.32|0.82|0.755
73942846|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.029|TWO_SIDED|95.0|0.6|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.97|0.60|0.029
73942847|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.015|TWO_SIDED|95.0|0.58|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.94|0.58|0.015
73942848|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.468|TWO_SIDED|95.0|0.71|1.17|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||1.17|0.71|0.468
73942849|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.011||95.0|0.57|0.93|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||0.93|0.57|0.011
73942850|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0|TWO_SIDED|95.0|0.5|0.82|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.82|0.50|0.000
73975068|NCT02307682|147496005|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-2.0|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 48||1.2|-2.0|
73975069|NCT02307682|147496005|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.6|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48||1.8|-1.6|
74031358|NCT02650284|147616157|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.64||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 12-months between both groups.||||0.64
73942851|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.696|TWO_SIDED|95.0|0.74|1.22|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||1.22|0.74|0.696
73942852|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81||||0.099|TWO_SIDED|95.0|0.64|1.04|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||1.04|0.64|0.099
73942853|NCT01218126|147418439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.86||||0.256|TWO_SIDED|95.0|0.67|1.11|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.11|0.67|0.256
73869051|NCT04042909|147282742|SUPERIORITY||beta coefficient|-0.309|STANDARD_ERROR_OF_MEAN|0.69||0.646|TWO_SIDED|95.0|-1.632|1.013||This is the p-value of the CAA vs AO factor in the model.|Regression, Linear|We used linear regression, controlling for baseline value of outcome and sex, to determine change in the outcome as a function of condition.||Our main hypothesis is that, relative to Assessment-Only control, the Counter Attitudinal Advocacy intervention will decrease alcohol consumption (drinks per week) from baseline to 6-months.||1.013|-1.632|.646
73942854|NCT01218126|147418440|SUPERIORITY_OR_OTHER||Rate ratio|1.0||||0.989|TWO_SIDED|95.0|0.64|1.54|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 2.5 mg arm) / (Rate of exacerbation in placebo arm)|Losmapimod 2.5 mg versus Placebo||1.54|0.64|0.989
73869052|NCT04042909|147282743|SUPERIORITY||beta coefficient|-1.9|STANDARD_ERROR_OF_MEAN|0.77||0.014|TWO_SIDED|95.0|-3.41|-0.39|||Regression, Linear|We used regression, controlling for baseline value of outcome and sex, to determine pre-post change in the outcome as a function of condition.||Our main hypothesis is that, relative to Assessment-Only control, the Counter Attitudinal Advocacy intervention will decrease alcohol problems from baseline to 6-months.||-0.39|-3.41|.014
73869053|NCT04124705|147282770|NON_INFERIORITY|If the lower limit of the 2-sided 95% confidence interval for stratified response rate difference was greater than the non-inferiority margin, the null hypothesis would be rejected and the noninferiority of Armour Thyroid to levothyroxine would be declared.|Stratified Response Rate Difference|-15.16|||||TWO_SIDED|95.0|-26.1|-4.23|||||The response rate difference (Armour Thyroid group minus Levothyroxine group) and the 95% confidence interval were calculated using the Mantel-Haenszel-weighted method with the age group (age \< 65 years or ≥ 65 years) as a stratification factor.|The null hypothesis was that Armour Thyroid would be inferior to levothyroxine for the primary efficacy endpoint, sustained TSH response. The non-inferiority hypothesis test was performed at a 1-sided 2.5% level of significance (equivalent to a two-sided 5% level of significance).||-4.23|-26.10|
73869054|NCT04124705|147282771|NON_INFERIORITY|If the lower limit of the 2-sided 95% confidence interval for stratified response rate difference was greater than the non-inferiority margin, the null hypothesis would be rejected and the noninferiority of Armour Thyroid to levothyroxine would be declared.|Stratified Response Rate Difference|-10.52|||||TWO_SIDED|95.0|-18.65|-2.38|||||The response rate difference (Armour Thyroid group minus Levothyroxine group) and the 95% confidence interval were calculated using the Mantel-Haenszel-weighted method with the age group (age \< 65 years or ≥ 65 years) as a stratification factor.|The null hypothesis was that Armour Thyroid would be inferior to levothyroxine for titration TSH response. The non-inferiority hypothesis test was performed at a 1-sided 2.5% level of significance.||-2.38|-18.65|
73869055|NCT02106403|147282810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.46||||0.0659|TWO_SIDED|95.0|-0.37|11.29|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||11.29|-0.37|0.0659
73869056|NCT02106403|147282810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.99||||0.0928|TWO_SIDED|95.0|-0.84|10.81|||ANCOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||10.81|-0.84|0.0928
73942855|NCT01218126|147418440|SUPERIORITY_OR_OTHER||Rate ratio|0.98||||0.915||95.0|0.64|1.5|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 7.5 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 7.5 mg||1.50|0.64|0.915
73942856|NCT01218126|147418440|SUPERIORITY_OR_OTHER||Rate ratio|0.74||||0.21|TWO_SIDED|95.0|0.47|1.18|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 15 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 15 mg||1.18|0.47|0.210
74031359|NCT02650284|147616157|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.19||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 24-months between both groups.||||0.19
73942857|NCT01860703|147418441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|||||TWO_SIDED|90.0|1.02|5.01||||||||5.01|1.02|
73942858|NCT01860703|147418447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.23|||||TWO_SIDED|90.0|3.26|7.19||||||||7.19|3.26|
73942859|NCT01860703|147418450|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|13.42|||||TWO_SIDED|90.0|11.1|15.75||||||||15.75|11.10|
73942860|NCT00251862|147418453|SUPERIORITY_OR_OTHER||Absolute Difference|8.3||||0.046|TWO_SIDED|95.0|-2.2|14.2|||Chi-squared|||Sample size and power considerations focused on a two-group comparison of the DA alone versus control study arms for the primary outcome of colorectal cancer (CRC) screening test completion at 12 months. Based on crude estimates of baseline test completion rates, we calculated that a target sample of 275 subjects per arm provided greater than 80% power of detecting a 54% vs. 40% difference at the P\<0.05 level.||14.2|-2.2|0.046
74031360|NCT02650284|147616157|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation preoperatively between both groups.||||0.57
73942861|NCT00251862|147418453|SUPERIORITY_OR_OTHER||Absolute Difference|6.0||||0.153|TWO_SIDED|95.0|0.2|16.5|||Chi-squared|||||16.5|0.2|0.153
73942862|NCT00251862|147418454|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons: DA+YDR vs. Control, P\<0.001; DA alone vs. Control, P\<0.001|ANCOVA|||The three study groups were compared on cumulative pre-test and post-test knowledge through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
73942863|NCT00251862|147418455|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
73869057|NCT02106403|147282810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||0.8711|TWO_SIDED|95.0|-5.35|6.31|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||6.31|-5.35|0.8711
73869058|NCT02106403|147282811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.43||||0.0016|TWO_SIDED|95.0|4.43|18.42|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||18.42|4.43|0.0016
73869059|NCT02106403|147282811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.69||||0.6323|TWO_SIDED|95.0|-5.31|8.69|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||8.69|-5.31|0.6323
74031361|NCT02650284|147616157|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.98||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 3-months between both groups.||||0.98
73942864|NCT00251862|147418456|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
73942865|NCT02453685|147418457|SUPERIORITY_OR_OTHER||Treatment difference at week 32|0.18||||0.0435|TWO_SIDED|95.0|0.01|0.36|||Mixed Models Analysis||"'Treatment difference' refers to BIAsp 30 minus Basal-bolus"|Analysis was performed using mixed model repeated measurements including treatment, region, and strata as fixed effects, HbA1c at baseline as covariate, interactions between all fixed effects and visit and using an unstructured residual covariance matrix.||0.36|0.01|0.0435
73942866|NCT01338025|147418525|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||||||0.03
73942867|NCT00949884|147418537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-3.8|-1.3|||ANCOVA|The ANCOVA model included treatment as a fixed effect and the baseline DBP as a covariate.||Null hypothesis was that there was no difference in change in seated diastolic blood pressure from baseline to end of treatment. Sample size of 900, this study had 90% power to detect a true difference in mean change from baseline in mean trough SDBP of 2.0 mmHg for Combined Olmesartan vs Losartan.||-1.3|-3.8|<0.0001
73942868|NCT00949884|147418538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-5.3|-1.8|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.||||-1.8|-5.3|<0.0001
73942869|NCT00949884|147418539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.99||0.0001|TWO_SIDED|95.0|-5.8|-1.9|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.||||-1.9|-5.8|0.0001
73942870|NCT00949884|147418540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-3.8|-1.5|||ANCOVA|ANCOVA model included treatment as a fixed effect and baseline blood pressure value as a covariate.||||-1.5|-3.8|<0.0001
73942871|NCT00949884|147418542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.55||0.1121|TWO_SIDED|95.0|-2.0|0.2|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.2|-2.0|0.1121
73942872|NCT00949884|147418542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.54||0.0783|TWO_SIDED|95.0|-2.0|0.1|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.1|-2.0|0.0783
73942873|NCT00949884|147418543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.92||0.2312|TWO_SIDED|95.0|-2.9|0.7|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.7|-2.9|0.2312
73869060|NCT02106403|147282811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.73||||0.0069|TWO_SIDED|95.0|2.74|16.73|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||16.73|2.74|0.0069
73942874|NCT00949884|147418543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.9||0.0979|TWO_SIDED|95.0|-3.2|0.3|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.3|-3.2|0.0979
73942875|NCT00949884|147418544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
74031362|NCT02650284|147616157|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.58||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 12-months between both groups.||||0.58
74031363|NCT02650284|147616157|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.16||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 24-months between both groups.||||0.16
73869061|NCT02106403|147282812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.13|||<|0.0001|TWO_SIDED|95.0|6.23|18.04|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||18.04|6.23|<0.0001
73942876|NCT00949884|147418544|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||0.0001
73942877|NCT00949884|147418544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||<0.0001
73942878|NCT00949884|147418544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||<0.0001
73942879|NCT00949884|147418544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||<0.0001
73942880|NCT00949884|147418544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||<0.0001
73942881|NCT00949884|147418544|SUPERIORITY_OR_OTHER|||||||0.2755||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.2755
73942882|NCT00949884|147418544|SUPERIORITY_OR_OTHER|||||||0.1646||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.1646
73942883|NCT00949884|147418544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||<0.0001
73942884|NCT00949884|147418544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||<0.0001
73942885|NCT00949884|147418544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.|Regression, Logistic|||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||<0.0001
73942886|NCT00949884|147418544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||<0.0001
74031364|NCT02650284|147616158|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.62||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score preoperatively between both groups.||||0.62
73942887|NCT00949884|147418544|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0010
74031365|NCT02650284|147616158|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.06||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score at 3-months between both groups.||||0.06
73942888|NCT00949884|147418544|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0011
73942889|NCT00949884|147418544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
73942890|NCT00949884|147418544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
73942891|NCT00949884|147418544|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0005
73942892|NCT00949884|147418544|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0004
73975070|NCT02307682|147496005|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 96||1.7|-1.9|
73975071|NCT02307682|147496005|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.7|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 96||1.9|-1.7|
73975072|NCT02307682|147496006|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.7|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||2.5|-1.7|
73975073|NCT02307682|147496006|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-1.7|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||2.5|-1.7|
73975074|NCT02307682|147496007|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||4.2|-4.2|
73975075|NCT02307682|147496007|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.8|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.8|-2.8|
73975076|NCT02307682|147496007|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.4|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||5.9|-4.4|
73942893|NCT00949884|147418544|SUPERIORITY_OR_OTHER|||||||0.0023||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0023
73942894|NCT00949884|147418544|SUPERIORITY_OR_OTHER|||||||0.0012||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0012
73942895|NCT00949884|147418545|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
73975077|NCT02307682|147496007|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-1.2|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||10.0|-1.2|
73975078|NCT02307682|147496007|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.9|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.9|-5.9|
73942896|NCT00949884|147418545|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
73975079|NCT02307682|147496007|OTHER||Difference in proportions|4.9|||||TWO_SIDED|95.0|-0.5|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||11.0|-0.5|
73942897|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||0.0009
73975080|NCT02307682|147496007|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.7|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.0|-3.7|
73975081|NCT02307682|147496007|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.8|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.3|-3.8|
73975082|NCT02307682|147496007|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.9|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.1|-5.9|
73975083|NCT02307682|147496007|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-2.4|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.9|-2.4|
73869062|NCT02106403|147282812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.18||||0.4645|TWO_SIDED|95.0|-8.09|3.72|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||3.72|-8.09|0.4645
73869063|NCT02106403|147282812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.32|||<|0.0001|TWO_SIDED|95.0|8.41|20.22|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||20.22|8.41|<0.0001
73942898|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||0.0007
73942899|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0347||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||0.0347
73942900|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||0.0280
73942901|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0519||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.0519
73942902|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0605||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.0605
73942903|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||0.0001
73942904|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||0.0003
73942905|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||0.0070
73942906|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0066||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||0.0066
74031366|NCT02650284|147616158|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.93||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score at 24-months between both groups.||||0.93
73942907|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0061||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0061
73942908|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0096
73942909|NCT00949884|147418545|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
73942910|NCT00949884|147418545|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
73942911|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0047
73942912|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0063
73942913|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0589
73942914|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0594||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0594
73942915|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0476||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<120/80 mmHg||||0.0476
73942916|NCT00949884|147418545|SUPERIORITY_OR_OTHER|||||||0.0657||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<120/80 mmHg||||0.0657
73942917|NCT00949884|147418546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.325|TWO_SIDED|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.||1.5|-4.4|0.3250
73975084|NCT02307682|147496007|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-4.2|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||7.3|-4.2|
73975085|NCT02307682|147496007|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|0.8|13.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||13.4|0.8|
73975086|NCT02307682|147496007|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.3|8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.5|-4.3|
73975087|NCT02307682|147496007|OTHER||Difference in proportions|3.2|||||TWO_SIDED|95.0|-3.4|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||9.4|-3.4|
73942918|NCT00949884|147418546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3491|TWO_SIDED|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.||1.5|-4.4|0.3491
73942919|NCT00949884|147418546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.2085|TWO_SIDED|95.0|-3.2|0.7|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.||0.7|-3.2|0.2085
73942920|NCT00949884|147418546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.2542|TWO_SIDED|95.0|-3.0|0.8|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.||0.8|-3.0|0.2542
73942921|NCT00949884|147418547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.0209|TWO_SIDED|95.0|-6.6|-0.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.||-0.5|-6.6|0.0209
73975088|NCT02307682|147496007|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.0|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||7.2|-5.0|
73975089|NCT02307682|147496007|OTHER||Difference in proportions|7.9|||||TWO_SIDED|95.0|1.5|14.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||14.4|1.5|
73975090|NCT02307682|147496007|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.4|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||7.0|-5.4|
73975091|NCT02307682|147496007|OTHER||Difference in proportions|8.1|||||TWO_SIDED|95.0|2.1|14.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||14.5|2.1|
73975092|NCT02307682|147496007|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-4.4|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||8.1|-4.4|
73942922|NCT00949884|147418547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.0186|TWO_SIDED|95.0|-6.6|-0.6|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.||-0.6|-6.6|0.0186
73942923|NCT00949884|147418547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0175|TWO_SIDED|95.0|-4.5|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.||-0.4|-4.5|0.0175
73975093|NCT02307682|147496007|OTHER||Difference in proportions|8.3|||||TWO_SIDED|95.0|2.0|15.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||15.1|2.0|
73975094|NCT02307682|147496007|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.2|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.1|-5.2|
73942924|NCT00949884|147418547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.0177|TWO_SIDED|95.0|-4.4|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.||-0.4|-4.4|0.0177
73942925|NCT00949884|147418548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.3104|TWO_SIDED|95.0|-5.2|1.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||1.7|-5.2|0.3104
73869064|NCT02106403|147282813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.41||||0.0357|TWO_SIDED|95.0|0.44|12.38|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||12.38|0.44|0.0357
73942926|NCT00949884|147418548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3653|TWO_SIDED|95.0|-4.9|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||1.8|-4.9|0.3653
73942927|NCT00949884|147418548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.1197|TWO_SIDED|95.0|-4.1|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||0.5|-4.1|0.1197
73942928|NCT00949884|147418548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.1654|TWO_SIDED|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||0.7|-3.9|0.1654
73942929|NCT00949884|147418548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.4362|TWO_SIDED|95.0|-4.4|1.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||1.9|-4.4|0.4362
73942930|NCT00949884|147418548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.4039|TWO_SIDED|95.0|-4.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||1.8|-4.5|0.4039
73942931|NCT00949884|147418548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.3929|TWO_SIDED|95.0|-3.1|1.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||1.2|-3.1|0.3929
73942932|NCT00949884|147418548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.4259|TWO_SIDED|95.0|-3.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||1.3|-3.0|0.4259
73942933|NCT00949884|147418549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0396|TWO_SIDED|95.0|-6.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||-0.2|-6.8|0.0396
73942934|NCT00949884|147418549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0345|TWO_SIDED|95.0|-6.8|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||-0.3|-6.8|0.0345
73942935|NCT00949884|147418549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0324|TWO_SIDED|95.0|-4.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||-0.2|-4.8|0.0324
73942936|NCT00949884|147418549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.0363|TWO_SIDED|95.0|-4.7|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||-0.2|-4.7|0.0363
73942937|NCT00949884|147418549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0988|TWO_SIDED|95.0|-6.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||0.6|-6.5|0.0988
73942938|NCT00949884|147418549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0926|TWO_SIDED|95.0|-6.4|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||0.5|-6.4|0.0926
73942939|NCT00949884|147418549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.09|TWO_SIDED|95.0|-4.5|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||0.3|-4.5|0.0900
73942940|NCT00949884|147418549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.0942|TWO_SIDED|95.0|-4.4|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||0.3|-4.4|0.0942
73942941|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.3229|TWO_SIDED|95.0|-5.4|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.8|-5.4|0.3229
73942942|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3863|TWO_SIDED|95.0|-5.1|2.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||2.0|-5.1|0.3863
73942943|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1277|TWO_SIDED|95.0|-4.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.6|-4.5|0.1277
73942944|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.1799|TWO_SIDED|95.0|-4.3|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.8|-4.3|0.1799
73942945|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.2708|TWO_SIDED|95.0|-5.1|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||1.4|-5.1|0.2708
73942946|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3133|TWO_SIDED|95.0|-5.0|1.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||1.6|-5.0|0.3133
73942947|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.1621|TWO_SIDED|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.7|-3.9|0.1621
73942948|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2314|TWO_SIDED|95.0|-3.7|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.9|-3.7|0.2314
73942949|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.2461|TWO_SIDED|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||1.3|-5.0|0.2461
73942950|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.2558|TWO_SIDED|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||1.3|-5.0|0.2558
73942951|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.17|TWO_SIDED|95.0|-3.8|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||0.7|-3.8|0.1700
73942952|NCT00949884|147418550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2011|TWO_SIDED|95.0|-3.7|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||0.8|-3.7|0.2011
73942953|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.1895|TWO_SIDED|95.0|-7.0|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.4|-7.0|0.1895
73942954|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.2701|TWO_SIDED|95.0|-6.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.8|-6.5|0.2701
73942955|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.1328|TWO_SIDED|95.0|-5.2|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.7|-5.2|0.1328
73942956|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1778|TWO_SIDED|95.0|-4.9|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.9|-4.9|0.1778
73942957|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.062|TWO_SIDED|95.0|-7.3|0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||0.2|-7.3|0.0620
73942958|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1011|TWO_SIDED|95.0|-6.9|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||0.6|-6.9|0.1011
73942959|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0249|TWO_SIDED|95.0|-5.6|-0.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||-0.4|-5.6|0.0249
73942960|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.0497|TWO_SIDED|95.0|-5.2|0.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.0|-5.2|0.0497
73942961|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0552|TWO_SIDED|95.0|-7.1|0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||0.1|-7.1|0.0552
73942962|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.0767|TWO_SIDED|95.0|-6.8|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||0.3|-6.8|0.0767
73942963|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.0279|TWO_SIDED|95.0|-5.3|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||-0.3|-5.3|0.0279
73942964|NCT00949884|147418551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0434|TWO_SIDED|95.0|-5.0|-0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||-0.1|-5.0|0.0434
73942965|NCT00949884|147418552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0009|TWO_SIDED|95.0|-6.8|-1.8|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Diastolic blood pressure||-1.8|-6.8|0.0009
73975095|NCT02307682|147496007|OTHER||Difference in proportions|7.6|||||TWO_SIDED|95.0|0.7|13.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||13.8|0.7|
73942966|NCT00949884|147418552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.5|-4.7|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Systolic blood pressure||-4.7|-12.5|<0.0001
73942967|NCT03092375|147418557|OTHER|Study is not intended to be powered|Mean Difference (Final Values)|-0.76|||||TWO_SIDED|95.0|-9.48|5.12|||||Excludes re-infection and death|The difference in the percentage of subjects with on-treatment virologic failure (Defined as increase of \>1 log10 IU/mL above nadir during treatment, or HCV RNA \>= 15 IU/mL at end of treatment with at least 6 weeks of treatment between Arms A and B are summarized with two-sided 95% Wilson score intervals.||5.12|-9.48|
73942968|NCT03092375|147418558|OTHER|The difference in the percentage of subjects with post-treatment relapse between Arms A and B are summarized with two-sided 95% Wilson score intervals.|Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-10.49|5.49||||||||5.49|-10.49|
73942969|NCT03092375|147418559|OTHER|Difference in percentage of subjects with on-treatment virologic failure between Arms C and D will be summarized with two-sided 95% Wilson score intervals|Mean Difference (Final Values)|9.52|||||TWO_SIDED|95.0|-3.03|22.08||||||||22.08|-3.03|
73942970|NCT03092375|147418560|OTHER||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-13.85|10.22||||||Excludes re-infection and death||10.22|-13.85|
73942971|NCT03092375|147418561|OTHER|Study was not powered to compare efficacy|Logistic Regression Contrast Estimate|-0.812||||0.161|TWO_SIDED|95.0|-1.947|0.323|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Comparison of Arm Pair A/C versus B/D overall on mITT population|||0.323|-1.947|0.161
73869065|NCT02106403|147282813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02||||0.503|TWO_SIDED|95.0|-3.95|8.0|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||8.00|-3.95|0.5030
73869066|NCT02106403|147282813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39||||0.1482|TWO_SIDED|95.0|-1.59|10.36|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||10.36|-1.59|0.1482
73869067|NCT03533244|147282815|SUPERIORITY|||||||0.218||||||To reserve the family-wise error rate, the main treatment effect will be first assessed at the global level at alpha = 0.05. If this is significant, then pairwise comparisons will be conducted using the Bonferroni adjustment for multiplicity.|Mixed Models Analysis|||An empirical sample size estimation was used as this was an exploratory study. The null hypothesis is that there is no difference between AG-86893 and AG-86893 Vehicle. It is expected that the active group is at least 50% better than the vehicle.||||0.218
73869068|NCT03533244|147282815|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.290
73869069|NCT03533244|147282816|SUPERIORITY|||||||0.193|||||||Mixed Models Analysis|||||||0.193
73869070|NCT03533244|147282816|SUPERIORITY|||||||0.399|||||||Mixed Models Analysis|||||||0.399
73869071|NCT03533244|147282817|SUPERIORITY|||||||0.015|||||||Fisher Exact|||||||0.015
73869072|NCT03533244|147282817|SUPERIORITY|||||||0.022|||||||Fisher Exact|||||||0.022
73942972|NCT03092375|147418561|OTHER|Study is not powered to compare efficacy of 12 wks vs 16 weeks of treatment|Logistic regression contrast estimate|0.89||||0.89|TWO_SIDED|95.0|-1.239|1.076|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Difference in proportion of SVR12 rates for 12 vs 16 weeks on mITT Comparing Cirrhotic subjects versus non-cirrhotic subjects.|||1.076|-1.239|0.890
73942973|NCT03092375|147418561|OTHER|Study is not powered|Logistic regression contrast estimate|0.977||||0.265|TWO_SIDED|95.0|-0.74|2.694|||Chi-squared|||Comparison of 12 weeks vs 16 weeks in Genotype 1b vs non-1b||2.694|-0.740|0.265
73942974|NCT01023568|147418600|NON_INFERIORITY_OR_EQUIVALENCE|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|14.0|||>|0.99|TWO_SIDED|95.0|7.0|26.0|||Wilcoxon (Mann-Whitney)||Glidescope - direct laryngoscopy|||26|7|>0.99
73975096|NCT02307682|147496007|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-6.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-6.8|
73869073|NCT01496846|147282818|SUPERIORITY|||||||0.901|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.901
73869074|NCT01496846|147282818|SUPERIORITY|||||||0.004|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.004
73869075|NCT01496846|147282819|SUPERIORITY|||||||0.437|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.437
73869076|NCT02024724|147282820|SUPERIORITY||Median Difference (Final Values)|-30.0||||0.196|TWO_SIDED|95.0|-45.0|10.0|||Chi-squared|||||10.00|-45.00|.196
73869077|NCT02019875|147282827|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.884|TWO_SIDED|95.0|-21.2|18.3|||Mixed Models Analysis|||||18.3|-21.2|0.884
73869078|NCT02019875|147282827|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.955|TWO_SIDED|95.0|-19.5|20.7|||Mixed Models Analysis|||||20.7|-19.5|0.955
73869079|NCT02019875|147282827|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.53|TWO_SIDED|95.0|-26.5|13.6|||Mixed Models Analysis|||||13.6|-26.5|0.53
73869080|NCT02019875|147282827|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.434|TWO_SIDED|95.0|-27.6|11.9|||Mixed Models Analysis|||||11.9|-27.6|0.434
73869081|NCT02019875|147282827|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.796|TWO_SIDED|95.0|-24.2|18.6|||Mixed Models Analysis|||||18.6|-24.2|0.796
73869082|NCT02019875|147282828|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.62|TWO_SIDED|95.0|-6.0|3.6|||Mixed Models Analysis|||||3.6|-6.0|0.62
73869083|NCT02019875|147282828|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.482|TWO_SIDED|95.0|-3.1|6.7|||Mixed Models Analysis|||||6.7|-3.1|0.482
73869084|NCT02019875|147282828|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.559|TWO_SIDED|95.0|-3.4|6.4|||Mixed Models Analysis|||||6.4|-3.4|0.559
73869085|NCT02019875|147282828|SUPERIORITY||Mean Difference (Final Values)|3.7||||0.138|TWO_SIDED|95.0|-1.2|8.5|||Mixed Models Analysis|||||8.5|-1.2|0.138
73869086|NCT02019875|147282828|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.477|TWO_SIDED|95.0|-7.1|3.3|||Mixed Models Analysis|||||3.3|-7.1|0.477
73869087|NCT02019875|147282829|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.98|TWO_SIDED|95.0|-11.0|11.3|||Mixed Models Analysis|||||11.3|-11.0|0.98
73869088|NCT02019875|147282829|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.81|TWO_SIDED|95.0|-10.0|12.7|||Mixed Models Analysis|||||12.7|-10.0|0.81
73869089|NCT02019875|147282829|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.91|TWO_SIDED|95.0|-10.8|12.2|||Mixed Models Analysis|||||12.2|-10.8|0.91
73869090|NCT02019875|147282829|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.68|TWO_SIDED|95.0|-8.9|13.8|||Mixed Models Analysis|||||13.8|-8.9|0.68
73869091|NCT02019875|147282829|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.96|TWO_SIDED|95.0|-11.9|12.6|||Mixed Models Analysis|||||12.6|-11.9|0.96
73869092|NCT02019875|147282830|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.17|TWO_SIDED|95.0|-2.7|0.5|||Mixed Models Analysis|||||0.5|-2.7|0.17
73869093|NCT02019875|147282830|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.44|TWO_SIDED|95.0|-1.0|2.2|||Mixed Models Analysis|||||2.2|-1.0|0.44
73869094|NCT02019875|147282830|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.94|TWO_SIDED|95.0|-1.7|1.6|||Mixed Models Analysis|||||1.6|-1.7|0.94
73869095|NCT02019875|147282830|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.0001|TWO_SIDED|95.0|2.1|5.2|||Mixed Models Analysis|||||5.2|2.1|<0.0001
73869096|NCT02019875|147282830|SUPERIORITY||Mean Difference (Final Values)|3.9|||<|0.0001|TWO_SIDED|95.0|2.2|5.6|||Mixed Models Analysis|||||5.6|2.2|<0.0001
73869097|NCT02019875|147282831|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.43|TWO_SIDED|95.0|-0.027|0.012|||Mixed Models Analysis|||||0.012|-0.027|0.43
73869098|NCT02019875|147282831|SUPERIORITY||Mean Difference (Final Values)|-0.017||||0.09|TWO_SIDED|95.0|-0.037|0.003|||Mixed Models Analysis|||||0.003|-0.037|0.09
73869099|NCT02019875|147282831|SUPERIORITY||Mean Difference (Final Values)|-0.011||||0.29|TWO_SIDED|95.0|-0.031|0.009|||Mixed Models Analysis|||||0.009|-0.031|0.29
73942975|NCT01023568|147418600|NON_INFERIORITY_OR_EQUIVALENCE|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|17.0|||>|0.99|TWO_SIDED|95.0|6.0|28.0|||Wilcoxon (Mann-Whitney)||Truview PCD - direct laryngoscopy|||28|6|>0.99
73942976|NCT01023568|147418601|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANOVA|||||||0.28
73942977|NCT01023568|147418602|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||>|0.99|TWO_SIDED|95.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.||2|1|> 0.99
73942978|NCT01023568|147418602|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.18|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.||0|0|0.18
73869100|NCT02019875|147282831|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.61|TWO_SIDED|95.0|-0.025|0.015|||Mixed Models Analysis|||||0.015|-0.025|0.61
73869101|NCT02019875|147282831|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.46|TWO_SIDED|95.0|-0.03|0.014|||Mixed Models Analysis|||||0.014|-0.03|0.46
73869102|NCT02019875|147282832|SUPERIORITY||Mean Difference (Final Values)|-12.6||||0.53|TWO_SIDED|95.0|-52.0|26.7|||Mixed Models Analysis|||||26.7|-52.0|0.53
73869103|NCT02019875|147282832|SUPERIORITY||Mean Difference (Final Values)|-44.5||||0.03|TWO_SIDED|95.0|-84.5|-4.5|||Mixed Models Analysis|||||-4.5|-84.5|0.03
73869104|NCT02019875|147282832|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.72|TWO_SIDED|95.0|-47.3|32.8|||Mixed Models Analysis|||||32.8|-47.3|0.72
73869105|NCT02019875|147282832|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.89|TWO_SIDED|95.0|-36.6|42.2|||Mixed Models Analysis|||||42.2|-36.6|0.89
73869106|NCT02019875|147282832|SUPERIORITY||Mean Difference (Final Values)|38.0||||0.08|TWO_SIDED|95.0|-4.7|80.6|||Mixed Models Analysis|||||80.6|-4.7|0.08
73869107|NCT02019875|147282833|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.96|TWO_SIDED|95.0|-104.5|110.2|||Mixed Models Analysis|||||110.2|-104.5|0.96
73869108|NCT02019875|147282833|SUPERIORITY||Mean Difference (Final Values)|15.0||||0.79|TWO_SIDED|95.0|-94.2|124.2|||Mixed Models Analysis|||||124.2|-94.2|0.79
73869109|NCT02019875|147282833|SUPERIORITY||Mean Difference (Final Values)|71.3||||0.2|TWO_SIDED|95.0|-37.9|180.5|||Mixed Models Analysis|||||180.5|-37.9|0.20
73869110|NCT02019875|147282833|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.96|TWO_SIDED|95.0|-110.1|104.7|||Mixed Models Analysis|||||104.7|-110.1|0.96
73869111|NCT02019875|147282833|SUPERIORITY||Mean Difference (Final Values)|51.8||||0.38|TWO_SIDED|95.0|-64.7|168.2|||Mixed Models Analysis|||||168.2|-64.7|0.38
73869112|NCT03202134|147282838|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73869113|NCT03202134|147282839|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73869114|NCT03202134|147282840|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73869115|NCT03202134|147282841|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73869116|NCT03202134|147282842|SUPERIORITY|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
73869117|NCT00966550|147282844|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.0001
73869118|NCT00621140|147282853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.85|-0.53|||ANCOVA|||Linagliptin vs. Placebo||-0.53|-0.85|<0.0001
73869119|NCT00621140|147282854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|-0.58|-0.34|||ANCOVA|||Linagliptin vs. Placebo||-0.34|-0.58|<0.0001
73869120|NCT00621140|147282855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.76|-0.47|||ANCOVA|||Linagliptin vs. Placebo||-0.47|-0.76|<0.0001
73869121|NCT00621140|147282856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.82|-0.49|||ANCOVA|||Linagliptin vs. Placebo||-0.49|-0.82|<0.0001
73869122|NCT00621140|147282857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.31|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001||95.0|-30.37|-16.26|||ANCOVA|||Linagliptin vs. Placebo||-16.26|-30.37|<0.0001
73869123|NCT00621140|147282858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|2.81|<|0.0001||95.0|-23.11|-12.08|||ANCOVA|||Linagliptin vs. Placebo||-12.08|-23.11|<0.0001
73869124|NCT00621140|147282859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.98|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001||95.0|-27.21|-14.75|||ANCOVA|||Linagliptin vs. Placebo||-14.75|-27.21|<0.0001
73869125|NCT00621140|147282860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.36|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-27.05|-13.68|||ANCOVA|||Linagliptin vs. Placebo||-13.68|-27.05|<0.0001
73942979|NCT01023568|147418603|SUPERIORITY_OR_OTHER|||||||0.26|||||||ANOVA|||||||0.26
73869126|NCT00621140|147282861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.869||||0.0006||95.0|1.575|5.225|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.225|1.575|0.0006
73942980|NCT01023568|147418604|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>0.99
73942981|NCT00224770|147418605|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|6.6||0.324|ONE_SIDED|95.0||16.2|||Fisher Exact|One-sided test|MISTIE rate=14.8, 95% upper limit=25.1; medical rate=9.5, 95% upper limit=20.5; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of mortality than the medical arm.||16.2||0.324
73942982|NCT00224770|147418605|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|8.2||0.633|ONE_SIDED|95.0||11.2|||Fisher Exact|One-sided test|ICES rate=7.1, 95% upper limit=29.7; medical rate=9.5, 95% upper limit=20.5; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of mortality than the medical arm.||11.2||0.633
73942983|NCT00224770|147418606|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.6|STANDARD_ERROR_OF_MEAN|3.1||0.174|ONE_SIDED|95.0||11.7|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=0.0, 95% upper limit=6.9; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of procedure-related mortality within 7 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of procedure-related mortality than the medical arm.||11.7||0.174
73942984|NCT00224770|147418607|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.437|ONE_SIDED|95.0||1.5|||Fisher Exact|One-sided test|MISTIE rate=0.0, 95% upper limit=5.4; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of these infections than medical.||1.5||0.437
73942985|NCT00224770|147418607|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.75|ONE_SIDED|95.0||1.5|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of these infections than medical.||1.5||0.750
73942986|NCT00224770|147418608|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.2|STANDARD_ERROR_OF_MEAN|3.9||0.409|ONE_SIDED|95.0||9.6|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of symptomatic rebleeding than the medical arm.||9.6||0.409
73942987|NCT00224770|147418608|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.75|ONE_SIDED|95.0||2.2|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of symptomatic rebleeding than the medical arm.||2.2||0.750
73942988|NCT00224770|147418609|SUPERIORITY_OR_OTHER|||||||0.468|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.468
73942989|NCT00224770|147418609|SUPERIORITY_OR_OTHER|||||||0.294|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.294
73942990|NCT00224770|147418610|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.395
73869127|NCT00621140|147282863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.436||||0.0323||95.0|1.078|5.507|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.507|1.078|0.0323
73942991|NCT00224770|147418610|SUPERIORITY_OR_OTHER|||||||0.175|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.175
73942992|NCT00224770|147418611|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.||||<0.0001
73942993|NCT00224770|147418611|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.||||<0.0001
73942994|NCT00224770|147418612|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Sign test|Two-sided test||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.||||<0.0001
73975097|NCT02307682|147496007|OTHER||Difference in proportions|8.2|||||TWO_SIDED|95.0|2.2|15.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||15.0|2.2|
73975098|NCT02307682|147496007|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-3.9|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||9.2|-3.9|
73869128|NCT00621140|147282865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.243|||<|0.0001||95.0|2.665|6.755|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||6.755|2.665|<0.0001
73869129|NCT00621140|147282866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.38|STANDARD_DEVIATION|12.05|<|0.0001||95.0|-82.33|-34.43|||ANCOVA|||Linagliptin vs. Placebo||-34.43|-82.33|<0.0001
73869130|NCT02980133|147282883|SUPERIORITY||LS mean difference|1.9||||0.285|TWO_SIDED|95.0|-1.6|5.3||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.||5.3|-1.6|0.285
73869131|NCT02980133|147282884|SUPERIORITY||Least square (LS) mean difference|6.0|||<|0.001|TWO_SIDED|95.0|3.2|8.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (inhaled corticosteroid \[ICS\] or noncorticosteroid \[NCS\]), and investigational medicinal product (IMP) treatment group.||8.8|3.2|<0.001
73869132|NCT02980133|147282884|SUPERIORITY||LS mean difference|7.0|||<|0.001|TWO_SIDED|95.0|4.1|9.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.||9.8|4.1|<0.001
73869133|NCT01007838|147282894|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Statistical significance was accepted if p \< 0.05.|ANCOVA|||Omnibus ANCOVA. An interaction would suggests patients responded to exercise differently than controls||||0.30
73869134|NCT01007838|147282894|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||Statistical significance was accepted if p \< 0.05.|ANOVA|||Follow up ANOVA in chronic kideny disease patients only. An interaction would suggest patients allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.||||0.0017
73869135|NCT01007838|147282894|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||Statistical sigficance was accepted if p \< 0.05.|ANOVA|||Follow up ANOVA in healthy controls only. An interaction would suggest healthy controls allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.||||0.024
73942995|NCT00224770|147418612|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED||||||Sign test|Two-sided||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.||||0.791
74031367|NCT02650284|147616159|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at pre-operation timepoint.||||0.57
74031368|NCT02650284|147616159|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.17||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 3-months between both groups.||||0.17
74031369|NCT02650284|147616159|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.8||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 12-months between both groups.||||0.80
73869136|NCT00118430|147282906|SUPERIORITY_OR_OTHER||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis|||||||<0.001
73869137|NCT00118430|147282907|SUPERIORITY_OR_OTHER||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis|||||||< 0.001
73869138|NCT00118430|147282908|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73869139|NCT00118430|147282909|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Poisson|||||||<0.001
73869140|NCT00997594|147282939|NON_INFERIORITY_OR_EQUIVALENCE|Just a comparison of the percentage of hypertension between the 2 patient groups.|||||<|0.05||95.0|||||Chi-squared, Corrected|||||||<0.05
73869141|NCT02611817|147282940|SUPERIORITY||Clopper-Pearson method|13.7||||0.008|TWO_SIDED|95.0|3.8|23.7|||Cochran-Mantel-Haenszel|||P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by electronic data capture (EDC) stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||23.7|3.8|0.008
73869142|NCT02611817|147282941|SUPERIORITY||Clopper-Pearson method|7.3||||0.167|TWO_SIDED|95.0|-3.0|17.5|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||17.5|-3.0|0.167
73869143|NCT02611817|147282942|SUPERIORITY||Clopper-Pearson method|27.1||||0.002|TWO_SIDED|95.0|11.9|42.3|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||42.3|11.9|0.002
73869144|NCT02611817|147282943|SUPERIORITY||Clopper-Pearson method|4.3||||0.591|TWO_SIDED|95.0|-11.6|20.3|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||20.3|-11.6|0.591
73869145|NCT00931606|147282944|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
73869146|NCT00931606|147282944|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
73869147|NCT00931606|147282944|SUPERIORITY|||||||0.524|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.524
73869148|NCT00931606|147282944|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
73869149|NCT00931606|147282944|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
73942996|NCT00224770|147418613|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.9|STANDARD_ERROR_OF_MEAN|9.5||0.189|ONE_SIDED|95.0||26.6|||Fisher Exact|One-sided test|MISTIE rate=34.6, 95% upper limit=46.9; medical rate=23.7, 95% upper limit=37.7; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher proportion than the medical arm.||26.6||0.189
73942997|NCT00224770|147418613|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.2|STANDARD_ERROR_OF_MEAN|14.9||0.156|ONE_SIDED|95.0||43.7|||Fisher Exact|One-sided test|ICES rate=42.9, 95% upper limit=67.5; medical rate=23.7, 95% upper limit=37.7; comparison considers ICES rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher proportion than the medical arm.||43.7||0.156
73942998|NCT01106430|147418614|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.001||95.0|||||Peto-Peto-Prentice Wilcoxon Test|||||||=0.001
73942999|NCT01106430|147418615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.1||||0.001|TWO_SIDED|95.0|7.5|28.7|||Cochran-Mantel-Haenszel|||||28.7|7.5|0.001
73943000|NCT01106430|147418616|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.5|||<|0.001|TWO_SIDED|95.0|-9.3|-3.6|||ANCOVA|||||-3.6|-9.3|<0.001
73943001|NCT01106430|147418617|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.046|TWO_SIDED|95.0|-0.17|0.0|||ANCOVA|||||-0.00|-0.17|0.046
73943002|NCT01255592|147418623|SUPERIORITY_OR_OTHER||Ratio of AZD5069 80 mg to placebo|0.31||||0.004|TWO_SIDED|90.0|0.17|0.59|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.||0.59|0.17|0.004
73943003|NCT01255592|147418624|SUPERIORITY_OR_OTHER||Ratio of AZD5069 80 mg to placebo|0.64||||0.008|TWO_SIDED|90.0|0.49|0.84|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.||0.84|0.49|0.008
73943004|NCT01255592|147418625|SUPERIORITY_OR_OTHER||LS mean difference|6.78|STANDARD_ERROR_OF_MEAN|3.298||0.047|TWO_SIDED|90.0|1.22|12.33|||ANCOVA|||The 24-hour sputum weight on Visit 4 was compared between groups using ANCOVA (additive model) with treatment and inhaled corticosteroids/P. aeruginosa infection as fixed effects and baseline as a covariate.||12.33|1.22|0.047
73943005|NCT01255592|147418626|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.092||0.284|TWO_SIDED|90.0|-0.05|0.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.26|-0.05|0.284
73943006|NCT01255592|147418627|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.078||0.929|TWO_SIDED|90.0|-0.12|0.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.14|-0.12|0.929
73943007|NCT01255592|147418628|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.062||0.966|TWO_SIDED|90.0|-0.11|0.1|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.10|-0.11|0.966
73943008|NCT01255592|147418629|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.791|TWO_SIDED|90.0|-0.13|0.17|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.17|-0.13|0.791
73943009|NCT01255592|147418630|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.433|TWO_SIDED|90.0|-1.6|0.6|||ANCOVA|||The ANCOVA model used TDI as the response variable with treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and BDI as covariates.||0.6|-1.6|0.433
73943010|NCT01255592|147418631|SUPERIORITY_OR_OTHER||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|8.03||0.935|TWO_SIDED|90.0|-12.81|14.13|||ANCOVA|||Morning PEF: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||14.13|-12.81|0.935
73943011|NCT01255592|147418631|SUPERIORITY_OR_OTHER||LS mean difference|3.3|STANDARD_ERROR_OF_MEAN|7.35||0.654|TWO_SIDED|90.0|-9.02|15.64|||ANCOVA|||Evening PEF: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||15.64|-9.02|0.654
73943012|NCT01255592|147418632|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.329|TWO_SIDED|90.0|-0.09|0.36|||ANCOVA|||Describe your breathing: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.36|-0.09|0.329
73869150|NCT00931606|147282944|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
73869151|NCT00931606|147282944|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
73869152|NCT00931606|147282944|SUPERIORITY|||||||0.236|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.236
73869153|NCT00931606|147282944|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
73943013|NCT01255592|147418632|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.664|TWO_SIDED|90.0|-0.16|0.27|||ANCOVA|||How often do you cough?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.27|-0.16|0.664
73943014|NCT01255592|147418632|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|90.0|-0.04|0.54|||ANCOVA|||Night time symptom score: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.54|-0.04|0.152
73943015|NCT01255592|147418632|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.15|TWO_SIDED|90.0|-0.8|0.05|||ANCOVA|||What color is your sputum?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.05|-0.80|0.150
73943016|NCT01255592|147418632|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.248|TWO_SIDED|90.0|-0.06|0.35|||ANCOVA|||The amount of sputum you produced: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.35|-0.06|0.248
74089232|NCT04844021|147731562|OTHER|We used a multiple hypothesis testing framework to evaluate the effectiveness of Nudge+ vs. Nudge, considering: 1) Nudge+ is more effective than Nudge by over 10 percentage points (PP); 2) Nudge+ is as effective as Nudge, with a difference of no greater than 10 PP in either direction; and 3) Nudge+ is less effective than Nudge by over 10 PP. The 10 PP margin was selected based on discussions with health system leaders and previous studies to ensure the differences were clinically meaningful.|Marginal probability|0.22|||||TWO_SIDED|95.0|0.13|0.31||If the 95% confidence interval for the risk difference did not contain any values within a region (Nudge+ superior, equivalence, Nudge+ inferior), that region could be rejected.||||The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.||0.31|0.13|
73975099|NCT02307682|147496007|OTHER||Difference in proportions|4.8|||||TWO_SIDED|95.0|-1.5|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||11.4|-1.5|
73975100|NCT02307682|147496007|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-5.9|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||7.1|-5.9|
73975101|NCT02307682|147496007|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-3.1|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||9.7|-3.1|
73975102|NCT02307682|147496007|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-6.5|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.5|-6.5|
73975103|NCT02307682|147496007|OTHER||Difference in proportions|4.9|||||TWO_SIDED|95.0|-1.3|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||11.4|-1.3|
73975104|NCT02307682|147496007|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-2.9|10.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||10.2|-2.9|
73975105|NCT02307682|147496007|OTHER||Difference in proportions|5.8|||||TWO_SIDED|95.0|-0.4|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||12.3|-0.4|
73975106|NCT02307682|147496007|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-4.2|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.0|-4.2|
73975107|NCT02307682|147496007|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-0.2|11.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||11.9|-0.2|
73975108|NCT02307682|147496007|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-3.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||9.9|-3.0|
73975109|NCT02307682|147496007|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.1|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||11.4|-1.1|
73975110|NCT02307682|147496007|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-1.5|12.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||12.8|-1.5|
73975111|NCT02307682|147496007|OTHER||Difference in proportions|5.0|||||TWO_SIDED|95.0|-1.0|11.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||11.6|-1.0|
73975112|NCT02307682|147496007|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.1|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.6|-5.1|
73975113|NCT02307682|147496007|OTHER||Difference in proportions|8.8|||||TWO_SIDED|95.0|2.7|15.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||15.4|2.7|
73869154|NCT00931606|147282944|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
74089233|NCT04844021|147731562|OTHER|We used a multiple hypothesis testing framework to evaluate the effectiveness of Nudge+ vs. Nudge, considering: 1) Nudge+ is more effective than Nudge by over 10 percentage points (PP); 2) Nudge+ is as effective as Nudge, with a difference of no greater than 10 PP in either direction; and 3) Nudge+ is less effective than Nudge by over 10 PP. The 10 PP margin was selected based on discussions with health system leaders and previous studies to ensure the differences were clinically meaningful.|Marginal probability|0.49|||||TWO_SIDED|95.0|0.37|0.61||If the 95% confidence interval for the risk difference did not contain any values within a region (Nudge+ superior, equivalence, Nudge+ inferior), that region could be rejected.||||The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.||0.61|0.37|
74089234|NCT00606502|147731581|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.84|||||TWO_SIDED|95.0|0.61|1.14||||||||1.14|0.61|
73943017|NCT01255592|147418632|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.053|TWO_SIDED|90.0|-0.45|-0.04|||ANCOVA|||Type of sputum: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||-0.04|-0.45|0.053
73943018|NCT01255592|147418632|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.179|TWO_SIDED|90.0|-0.04|0.42|||ANCOVA|||How do you feel?: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.42|-0.04|0.179
73943019|NCT01255592|147418632|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.942|TWO_SIDED|90.0|-0.75|0.68|||ANCOVA|||Number of puffs of inhalers: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.68|-0.75|0.942
73943020|NCT01255592|147418633|SUPERIORITY_OR_OTHER||LS mean difference|-1.66|STANDARD_ERROR_OF_MEAN|3.374||0.625|TWO_SIDED|90.0|-7.32|4.0|||ANCOVA|||Total score: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||4.00|-7.32|0.625
73943021|NCT01255592|147418633|SUPERIORITY_OR_OTHER||LS mean difference|-4.88|STANDARD_ERROR_OF_MEAN|3.342||0.151|TWO_SIDED|90.0|-10.49|0.74|||ANCOVA|||Symptom domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.74|-10.49|0.151
73943022|NCT01255592|147418633|SUPERIORITY_OR_OTHER||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|4.524||0.773|TWO_SIDED|90.0|-8.91|6.28|||ANCOVA|||Activity domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.28|-8.91|0.773
73943023|NCT01255592|147418633|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|3.845||0.92|TWO_SIDED|90.0|-6.84|6.07|||ANCOVA|||Impact domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.07|-6.84|0.920
73943024|NCT01255592|147418634|SUPERIORITY_OR_OTHER||Ratio of LS means|0.69||||0.22|TWO_SIDED|90.0|0.42|1.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.14|0.42|0.220
73943025|NCT01255592|147418635|SUPERIORITY_OR_OTHER||Ratio of LS means|4.46|||<|0.001|TWO_SIDED|90.0|3.05|6.54|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.54|3.05|<0.001
73943026|NCT01255592|147418636|SUPERIORITY_OR_OTHER||Ratio of LS means|0.92||||0.67|TWO_SIDED|90.0|0.68|1.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.26|0.68|0.670
73943027|NCT01255592|147418637|SUPERIORITY_OR_OTHER||Ratio of LS means|0.99||||0.968|TWO_SIDED|90.0|0.78|1.27|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.27|0.78|0.968
73943028|NCT01255592|147418638|SUPERIORITY_OR_OTHER||Ratio of LS means|1.43||||0.193|TWO_SIDED|90.0|0.91|2.24|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.24|0.91|0.193
73943029|NCT01255592|147418639|SUPERIORITY_OR_OTHER||Ratio of LS means|3.24|||<|0.001|TWO_SIDED|90.0|2.19|4.79|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||4.79|2.19|<0.001
73943030|NCT01255592|147418640|SUPERIORITY_OR_OTHER||Ratio of LS means|1.02||||0.917|TWO_SIDED|90.0|0.71|1.48|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.48|0.71|0.917
73869155|NCT00931606|147282947|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
73943031|NCT01255592|147418641|SUPERIORITY_OR_OTHER||Ratio of LS means|0.17||||0.111|TWO_SIDED|90.0|0.03|1.08|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.08|0.03|0.111
73943032|NCT01255592|147418642|SUPERIORITY_OR_OTHER||Ratio of LS means|1.33||||0.367|TWO_SIDED|90.0|0.79|2.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.26|0.79|0.367
73943033|NCT01255592|147418643|SUPERIORITY_OR_OTHER||Ratio of LS means|1.54||||0.112|TWO_SIDED|90.0|0.98|2.4|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.40|0.98|0.112
73943034|NCT01255592|147418644|SUPERIORITY_OR_OTHER||Ratio of LS means|1.05||||0.241|TWO_SIDED|90.0|0.98|1.12|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.12|0.98|0.241
73943035|NCT01255592|147418645|SUPERIORITY_OR_OTHER||Ratio of LS means|5.5|||<|0.001|TWO_SIDED|90.0|4.18|7.23|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||7.23|4.18|<0.001
73943036|NCT01255592|147418646|SUPERIORITY_OR_OTHER||Ratio of LS means|1.16||||0.281|TWO_SIDED|90.0|0.92|1.47|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.47|0.92|0.281
73943037|NCT01255592|147418647|SUPERIORITY_OR_OTHER||Ratio of LS means|1.56||||0.001|TWO_SIDED|90.0|1.28|1.91|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.91|1.28|0.001
73943038|NCT01255592|147418648|SUPERIORITY_OR_OTHER||Ratio of LS means|6.07|||<|0.001|TWO_SIDED|90.0|4.42|8.35|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||8.35|4.42|<0.001
73943039|NCT04791761|147418694|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Null hypothesis: No difference in average pain scores before medication between opioid and non-opioid groups.||||0.8
73943040|NCT04791761|147418694|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference in average pain scores after medication between opioid and non-opioid groups.||||0.7
73975114|NCT02307682|147496007|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.7|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.4|-3.7|
73975115|NCT02307682|147496007|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-2.2|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||10.3|-2.2|
73943041|NCT04791761|147418695|SUPERIORITY|||||||0.2|||||||Fisher Exact|||Null hypothesis: There will be no difference in the proportion of patients visiting the emergency department or urgent care post-operatively between opioid and non-opioid groups.||||0.2
73943042|NCT00089141|147418708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.22||95.0|0.7|3.7||P values are 2 sided and are based on likelihood ratio statistics.|Regression, Cox|Analysis for all endpoints was stratified by number of affected organs and type of conditioning regimen.|For all analyses, MMF arm in numerator, and placebo arm in denominator. Hazard ratio estimate includes 3 efficacy success events that occurred after two years in the placebo arm.|||3.7|0.7|.22
73943043|NCT00089141|147418709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||0.03||95.0|1.1|2.6|||Regression, Cox|Statistical analysis did not count treatment continuing beyond 2 years as efficacy failure (n = 2 in each arm).||||2.6|1.1|.03
73975116|NCT02307682|147496007|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-3.0|10.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||10.9|-3.0|
73975117|NCT02307682|147496007|OTHER||Difference in proportions|8.0|||||TWO_SIDED|95.0|1.9|14.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||14.6|1.9|
73943044|NCT00089141|147418710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.55||95.0|0.7|2.1|||Regression, Cox|||||2.1|0.7|.55
73943045|NCT00089141|147418711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.61||||0.48||95.0|0.4|6.0|||Regression, Cox|||||6.0|0.4|.48
73943046|NCT00089141|147418712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.17||95.0|0.8|3.9|||Regression, Cox|adjusted for risk category||||3.9|0.8|.17
73975118|NCT02307682|147496007|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-5.1|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.3|-5.1|
73975119|NCT02307682|147496007|OTHER||Difference in proportions|5.9|||||TWO_SIDED|95.0|0.0|12.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||12.5|-0.0|
74031370|NCT02650284|147616159|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.9||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 24-months between both groups.||||0.90
73869156|NCT00931606|147282947|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
73943047|NCT00089141|147418713|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.62||||0.41||95.0|0.5|5.0|||Regression, Cox|||||5.0|0.5|.41
73943048|NCT00089141|147418714|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.69||||0.14||95.0|0.9|3.2|||Regression, Cox|||||3.2|0.9|.14
73943049|NCT00089141|147418715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.99||||0.1||95.0|0.9|4.3|||Regression, Cox|||||4.3|0.9|.10
73943050|NCT00089141|147418716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.34||95.0|0.08|2.1|||Regression, Cox|||||2.1|.08|.34
73943051|NCT00089141|147418717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.28||95.0|0.7|3.2|||Regression, Cox|||||3.2|0.7|.28
73943052|NCT00508261|147418723|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.64|||||TWO_SIDED|95.0|-0.33|4.71||||||Demonstration of the non-inferiority of Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup A, at month 1.||4.71|-0.33|
73975120|NCT02307682|147496007|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|-1.2|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.3|-1.2|
73943053|NCT00508261|147418723|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.73|||||TWO_SIDED|95.0|0.73|6.24||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup C, at month 1.||6.24|0.73|
73943054|NCT00508261|147418723|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.61|||||TWO_SIDED|95.0|-0.36|4.64||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup W-135, at month 1.||4.64|-0.36|
73943055|NCT00508261|147418723|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.7|||||TWO_SIDED|95.0|0.71|6.18||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup Y, at month 1.||6.18|0.71|
73943056|NCT00508261|147418724|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PT (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.97|||||TWO_SIDED|95.0|0.83|1.12||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT), at month 1.||1.12|0.83|
73943057|NCT00508261|147418724|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-FHA (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.98|||||TWO_SIDED|95.0|0.85|1.13||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to filamentous haemagglutinin (FHA), at month 1.||1.13|0.85|
73943058|NCT00508261|147418724|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PRN (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.92|||||TWO_SIDED|95.0|0.78|1.1||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertactin (PRN), at month 1.||1.1|0.78|
73943059|NCT00508261|147418725|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentages of subjects with anti-HBs antibody concentrations ≥10 mIU/ml is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.22|||||TWO_SIDED|95.0|-1.47|4.6||||||||4.6|-1.47|
73943060|NCT00508261|147418726|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentage of subjects with anti-PRP concentrations (ELISA) ≥1.0 μg/mL is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.19|||||TWO_SIDED|95.0|-1.45|4.5||||||||4.5|-1.45|
73943061|NCT00180479|147418752|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculation for endpoint of in-segment LL at 240 days is based on these assumptions: one-tailed non-inferiority= (δ)=0.025, Power=99%, Randomization ratio 2:1, True mean in-seg. LL is assumed to be 0.24 mm in both arms.|||||<|0.0001|||||||t-test, 1 sided|||Primary endpoint analyzed for intent-to-treat \& per-treatment evaluable pop. Hypothesis test based on per-subject analysis of intent-to-treat pop. using analysis lesion. The null hypothesis evaluated using non-inferiority test with asymptotic test statistic.||||<0.0001
73943062|NCT00180479|147418753|NON_INFERIORITY_OR_EQUIVALENCE|Study had 89% statistical power based on major secondary endpoint to prove non-inferiority of XIENCE® V to TAXUS®, non-inferiority delta=5.5%, true TVF rate 9.4% in both arms with overall 5% alpha (one-sided), assuming 1% subject dropout rate.|||||<|0.0001|||||||t-test, 1 sided|||Null hypothesis was evaluated using a non-inferiority Z statistic. Non-inferiority was defined as a one-sided alpha of 0.05 and a difference in TVF rate of no more than 5.5%.||||<0.0001
73943063|NCT05131165|147418796|SUPERIORITY|||||||0.056||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.056
73975121|NCT02307682|147496007|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|1.4|13.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||13.8|1.4|
73869157|NCT00931606|147282947|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
73869158|NCT00931606|147282947|SUPERIORITY||||||>|0.999|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
73943064|NCT05131165|147418796|SUPERIORITY|||||||0.062||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.062
73943065|NCT05131165|147418797|SUPERIORITY|||||||0.364||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.364
73943066|NCT05131165|147418797|SUPERIORITY|||||||0.409||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.409
73943067|NCT05131165|147418798|SUPERIORITY|||||||0.158||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.158
73943068|NCT05131165|147418798|SUPERIORITY|||||||0.017||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.017
73943069|NCT05131165|147418799|SUPERIORITY|||||||0.654||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.654
73943070|NCT05131165|147418799|SUPERIORITY|||||||0.035||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.035
73943071|NCT05131165|147418801|SUPERIORITY|||||||0.5468|||||||t-test, 2 sided|||The analyses compared the change in viral suppression status of the participants from baseline to month 9. For each participant, we derived the change in viral suppression status by subtracting two binary variables - one indicating whether the participant was virally suppressed at baseline (based on their chart records from around 3 months prior to baseline) and the other indicating whether the participant was virally suppressed at around month 9 of the study.||||0.5468
73943072|NCT05131165|147418801|SUPERIORITY|||||||0.5255|||||||t-test, 2 sided|||The analyses compared the change in viral suppression status of the participants from baseline to month 9. For each participant, we derived the change in viral suppression status by subtracting two binary variables - one indicating whether the participant was virally suppressed at baseline (based on their chart records from around 3 months prior to baseline) and the other indicating whether the participant was virally suppressed at around month 9 of the study.||||0.5255
73943073|NCT02298361|147418821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|1.6|1.93|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)|||1.93|1.60|
73943074|NCT02298361|147418821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|1.91|2.72|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)|||2.72|1.91|
73943075|NCT02298361|147418822|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.53|0.94|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of losing Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)|||0.94|0.53|
74031371|NCT02650284|147616161|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.81||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare length of hospital stay (number of nights) between both groups.||||0.81
73869159|NCT00931606|147282948|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
73869160|NCT00931606|147282948|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
73869161|NCT00931606|147282948|SUPERIORITY|||||||0.206|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.206
73943076|NCT02298361|147418822|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.45|0.67|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of losing Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)|||0.67|0.45|
73943077|NCT02459262|147418850|OTHER|ANOVA repeated measures: In-transformed antibody concentrations as dependent variable; dose level, time, presence of adjuvant and dose\*time interaction as fixed effects; subjects as random effects||||||0.0193||||||Adjuvant effect at Day 85, the primary immunological endpoint|ANOVA|Adjuvant effect, with higher antibody concentration values after all dose levels of vaccine was significant at all time points (D29, D43, D57, Day 85)||The objectives for Part A were to evaluate the effect of adjuvant and to inform the selection of dose levels for Part B. The study was not powered for inter-group comparisons.||||0.0193
73943078|NCT02459262|147418851|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
73943079|NCT02459262|147418852|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
73943080|NCT01242748|147418854|NON_INFERIORITY_OR_EQUIVALENCE|Degarelix was considered to be non-inferior to goserelin with regard to the hazard ratio of PSA PFS failure rates as the upper limit of the two-sided 95% CI of the adjusted hazard ratio was less than the non-inferiority margin of 1.33.|Hazard Ratio (HR)|0.774||||0.1589|TWO_SIDED|95.0|0.542|1.106|||Cox proportional hazard model|||The hazard ratio of PSA PFS failure rates was estimated using the Cox proportional hazard model with time to PSA PFS failure as dependent and treatment as independent variables and adjusted for baseline PSA category, prostate cancer stage, weight and geographical region. Degarelix was to be considered non-inferior to goserelin if the upper limit of the two-sided 95% confidence interval (CI) of the adjusted hazard ratio was less than or equal to the non-inferiority margin of 1.33.||1.106|0.542|0.1589
73943081|NCT01242748|147418855|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.783||||0.1244|TWO_SIDED|95.0|0.574|1.07|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.070|0.574|0.1244
73943082|NCT01242748|147418856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856|||||TWO_SIDED|95.0|0.58|1.263||||||The hazard ratio was estimated using the Cox proportional hazard model.||1.263|0.580|
73943083|NCT01242748|147418857|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.511||||0.0005|TWO_SIDED|95.0|1.739|7.09|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||7.090|1.739|0.0005
73975122|NCT02307682|147496008|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-4.3|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.9|-4.3|
73975123|NCT02307682|147496008|OTHER||Difference in proportions|6.3|||||TWO_SIDED|95.0|0.6|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||12.2|0.6|
73975124|NCT02307682|147496008|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-6.6|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.7|-6.6|
73975125|NCT02307682|147496008|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.7|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||8.0|-4.7|
73975126|NCT02307682|147496008|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.2|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||7.1|-6.2|
73975127|NCT02307682|147496008|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-0.8|12.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||12.7|-0.8|
73975128|NCT02307682|147496008|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-6.0|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||7.7|-6.0|
73943084|NCT01242748|147418858|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739||||0.143|TWO_SIDED|95.0|0.493|1.108|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.108|0.493|0.143
73975129|NCT02307682|147496008|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-1.5|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||12.2|-1.5|
73943085|NCT01242748|147418859|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.595||||0.2212|TWO_SIDED|95.0|0.259|1.368|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.368|0.259|0.2212
73943086|NCT00840801|147418862|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A stratified score test was used to test the non-inferiority with a margin of -10% at 2.5% type I error (one-sided).|||||<|0.001|||||||Stratified score test|||Non-inferiority Test on Seropositive Response Rate||||<0.001
73975130|NCT02307682|147496008|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-6.5|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.0|-6.5|
73869162|NCT00931606|147282948|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
73975131|NCT02307682|147496008|OTHER||Difference in proportions|5.2|||||TWO_SIDED|95.0|-1.8|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||12.2|-1.8|
73943087|NCT02416492|147418946|SUPERIORITY||Least Square (LS) Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|2.9||0.0401|TWO_SIDED|95.0||||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||||0.0401
73943088|NCT02416492|147418947|SUPERIORITY||Least Square (LS) Mean Difference|-0.7||||0.1655|TWO_SIDED|95.0|-1.7|0.3||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||0.3|-1.7|0.1655
73943089|NCT02416492|147418948|SUPERIORITY||Least Square (LS) Mean Difference|2.7||||0.3398|TWO_SIDED|95.0|-2.9|8.3|||Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||8.3|-2.9|0.3398
73943090|NCT02416492|147418949|SUPERIORITY||Least Square (LS) Mean Difference|-2.6||||0.8974|TWO_SIDED|95.0|-42.2|37.1||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||37.1|-42.2|0.8974
73943091|NCT02416492|147418950|SUPERIORITY||Least Square (LS) Mean Difference|-0.49||||0.8534|TWO_SIDED|95.0|-5.77|4.8||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Change from Baseline in NeuroQOL Upper Extremity Function T Score at Week 24||4.80|-5.77|0.8534
73943092|NCT02416492|147418950|SUPERIORITY||Least Square (LS) Mean Difference|0.41||||0.8443|TWO_SIDED|95.0|-3.78|4.6||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Change from Baseline in NeuroQOL Lower Extremity Function T Score at Week 24||4.60|-3.78|0.8443
73943093|NCT02093663|147418952|OTHER||Odds Ratio (OR)|3.21||||0.039|TWO_SIDED|95.0|1.04|9.88|||Uncorrected Chi-squared Test|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (last observation carried forward \[LOCF\] and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||9.88|1.04|0.039
73943094|NCT02093663|147418953|OTHER||Odds Ratio (OR)|0.99||||0.981|TWO_SIDED|95.0|0.42|2.34||P-value were based on a Cochran-Mantel-Haenszel test stratified by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-value s were presented as descriptive statistics.||2.34|0.42|0.981
73943095|NCT02093663|147418954|OTHER||Difference in proportions|50.0||||0.4|TWO_SIDED|95.0|-19.3|100.0||P-value was calculated based on Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||100.0|-19.3|0.400
73943096|NCT02093663|147418955|OTHER||Difference in proportions|50.0||||0.333|TWO_SIDED|95.0|-19.3|100.0||P-value was based on a Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate.||100.0|-19.3|0.333
73943097|NCT02093663|147418956|OTHER||Difference in Least squares Mean|-5.4||||0.168|TWO_SIDED|95.0|-13.1|2.4||P-value is based on an analysis of covariance (ANCOVA) including treatment arm as a factor and baseline DUCS score as a covariate.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||2.4|-13.1|0.168
73975132|NCT02307682|147496008|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.0|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||9.5|-4.0|
74031372|NCT00554294|147616167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||<|0.05||95.0|0.48|0.98|||Regression, Logistic|The Odds Ratio (OR) describes the probability ob beeing overweight of the intervention group compared to the control group (reference, denominator).||adjusted for overweight at baseline, age at baseline,sex and clustering by school||0.98|0.48|<0.05
73869163|NCT00931606|147282948|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
73869164|NCT00931606|147282948|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
73869165|NCT00931606|147282948|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
73869166|NCT00931606|147282948|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
73975133|NCT02307682|147496008|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-3.5|11.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||11.3|-3.5|
73975134|NCT02307682|147496008|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.9|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.2|-5.9|
73975135|NCT02307682|147496008|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-3.4|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||11.2|-3.4|
73869167|NCT00931606|147282948|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
73869168|NCT00931606|147282948|SUPERIORITY|||||||0.143|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.143
73975136|NCT02307682|147496008|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-8.2|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.9|-8.2|
73975137|NCT02307682|147496008|OTHER||Difference in proportions|3.6|||||TWO_SIDED|95.0|-3.2|10.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||10.5|-3.2|
73975138|NCT02307682|147496008|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-7.3|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.8|-7.3|
73975139|NCT02307682|147496008|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.2|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||8.6|-5.2|
73975140|NCT02307682|147496008|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-7.8|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.6|-7.8|
74031373|NCT05022004|147616172|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-0.28|0.91|||||The reported mean difference represents value for Left Eye at Week 2, 08:00am|||0.91|-0.28|
73975141|NCT02307682|147496008|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.8|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||10.0|-4.8|
73975142|NCT02307682|147496008|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-4.4|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||9.2|-4.4|
73869169|NCT00931606|147282948|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
73869170|NCT00931606|147282949|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
73869171|NCT00931606|147282949|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
73869172|NCT00931606|147282949|SUPERIORITY|||||||0.206|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.206
73869173|NCT00931606|147282949|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
73869174|NCT00931606|147282949|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
73869175|NCT00931606|147282949|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
73869176|NCT00931606|147282949|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
73869177|NCT00931606|147282949|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
73975143|NCT02307682|147496008|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-7.1|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.2|-7.1|
73869178|NCT00931606|147282949|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
73943098|NCT02093663|147418957|OTHER||Difference in proportions|24.5||||0.131|TWO_SIDED|95.0|-1.6|50.6||P-value was based on a continuity-corrected chi-squared test. PUCAI Score was compared between treatment arms using a continuity corrected chi-squared test. Expected cell counts are very low (\< 5), then Fisher's Exact Test is alternative method.|Chi-squared, Corrected|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||50.6|-1.6|0.131
73869179|NCT00931606|147282949|SUPERIORITY|||||||0.143|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.143
73869180|NCT00931606|147282949|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
73869181|NCT02170870|147282972|SUPERIORITY|||||||0.06|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs diabetics adjusted for treatment status (ie, exendin or placebo)||||0.06
73943099|NCT02093663|147418958|OTHER||Difference in Proportions Percentage|-6.5||||0.539|TWO_SIDED|95.0|-25.3|12.3||P-value is based on a CMH test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||12.3|-25.3|0.539
73943100|NCT02093663|147418959|OTHER||Difference in proportions|-16.2||||0.129|TWO_SIDED|95.0|-36.0|3.6||P-value was based on a Cochran-Mantel-Haenszel (CMH) test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||3.6|-36.0|0.129
73943101|NCT02093663|147418960|OTHER||Difference in Least squares Mean|3.0||||0.182|TWO_SIDED|95.0|-1.4|7.4||P-value was based on an analysis of covariance (ANCOVA) including treatment arm and with prior response status.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||7.4|-1.4|0.182
73943102|NCT02093663|147418961|OTHER||Difference in proportions|-9.0||||0.194|TWO_SIDED|95.0|-29.1|11.0||P-value was based on a CMH test adjusted by prior response status. Participants with remission (PUCAI \<10) at double-blind maintenance phase at Week 26 was compared between treatment arms using a CMH test stratifying by Week 8 responder status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||11.0|-29.1|0.194
73943103|NCT00508404|147418969|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|1.02|4.45|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||4.45|1.02|
73943104|NCT00508404|147418970|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86|||||TWO_SIDED|95.0|0.88|3.93|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||3.93|0.88|
73943105|NCT00508404|147418971|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.3|3.89|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||3.89|0.30|
73943106|NCT00508404|147418972|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.283|||||TWO_SIDED|95.0|0.13|0.614|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.614|0.130|
73943107|NCT00508404|147418973|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.642|||||TWO_SIDED|95.0|0.99|2.721|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||2.721|0.990|
73943108|NCT00508404|147418974|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.464|||||TWO_SIDED|95.0|0.306|0.703|||||Hazard ratio presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.703|0.306|
73943109|NCT00508404|147418975|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.395|||||TWO_SIDED|95.0|0.252|0.618|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.618|0.252|
73943110|NCT00508404|147418976|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.756|||||TWO_SIDED|95.0|0.4|1.43|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||1.430|0.400|
73943111|NCT00508404|147418977|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.503|1.002|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||1.002|0.503|
73943112|NCT00508404|147418979|SUPERIORITY_OR_OTHER_LEGACY||Difference in rates|8.34|||||TWO_SIDED|95.0|-4.01|19.08||||||||19.08|-4.01|
73943113|NCT03662074|147418980|OTHER||||||||||||||||||The pre-specified analysis plan as per the protocol is to proceed to the second stage of recruitment for additional participants if the response proportion exceeds the historical control of 10%.|||
73943114|NCT03286751|147418999|SUPERIORITY||Ratio of Geometric LSMeans|1.01||||0.5495|TWO_SIDED|95.0|0.974|1.05|||Mixed Models Analysis|||||1.05|0.974|0.5495
73943115|NCT03286751|147418999|SUPERIORITY||Ratio of Geometric LSMeans|1.02||||0.2236|TWO_SIDED|95.0|0.986|1.06|||Mixed Models Analysis|||||1.06|0.986|0.2236
73943116|NCT03286751|147418999|SUPERIORITY||Ratio of Geometric LSMeans|1.03||||0.0727|TWO_SIDED|95.0|0.997|1.07|||Mixed Models Analysis|||||1.07|0.997|0.0727
73869182|NCT02170870|147282972|SUPERIORITY|||||||0.0001|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs functional dyspepsia adjusted for treatment status (ie, exendin or placebo)||||0.0001
73869183|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio (GMR)|1.14|||||TWO_SIDED|95.0|0.95|1.37||||||Serotype 1: Geometric mean ratios (GMRs) (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% confidence intervals (CIs).||1.37|0.95|
73869184|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio (GMR)|1.01|||||TWO_SIDED|95.0|0.88|1.16||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.16|0.88|
73869185|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.17|0.78|
74031374|NCT05022004|147616172|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-0.39|0.76|||||The reported mean difference represents value for Right Eye at Week 2, 08:00am|||0.76|-0.39|
73869186|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.12|0.77|
73869187|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.24|||||TWO_SIDED|95.0|1.03|1.5||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.50|1.03|
73869188|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.85|1.21||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.21|0.85|
73869189|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.82|1.17||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.17|0.82|
73869190|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.33|0.93|
73943117|NCT03286751|147419000|SUPERIORITY||Ratio of Geometric LSMeans|0.97||||0.5749|TWO_SIDED|95.0|0.87|1.08|||Mixed Models Analysis|||||1.08|0.87|0.5749
73943118|NCT03286751|147419000|SUPERIORITY||Ratio of Geometric LSMeans|0.92||||0.1578|TWO_SIDED|95.0|0.83|1.03|||Mixed Models Analysis|||||1.03|0.83|0.1578
73943119|NCT03286751|147419000|SUPERIORITY||Ratio of Geometric LSMeans|0.92||||0.1351|TWO_SIDED|95.0|0.83|1.03|||Mixed Models Analysis|||||1.03|0.83|0.1351
73943120|NCT00939874|147419004|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73943121|NCT01032733|147419006|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.06|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0|||||ANCOVA|||This trial represented a pilot study, which was designed to demonstrate the feasibility, acceptability, and efficacy of the intervention; therefore, a power analysis was not conducted. The statistical analyses consisted of descriptive and intent-to-treat (ITT) modeling procedures.||||<0.05
73943122|NCT01032733|147419007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_DEVIATION|5.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
73943123|NCT01032733|147419008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
73943124|NCT01032733|147419009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
73869191|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.9|1.27||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.27|0.90|
73869192|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.07|0.72|
73943125|NCT01032733|147419010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
73943126|NCT00834106|147419013|SUPERIORITY_OR_OTHER||Vaccine efficacy|76.0|||||TWO_SIDED|95.0|43.7|91.1|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||91.1|43.7|
73943127|NCT00834106|147419014|SUPERIORITY_OR_OTHER||Vaccine efficacy|82.3|||||TWO_SIDED|95.0|38.3|96.7|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||96.7|38.3|
73943128|NCT00834106|147419015|SUPERIORITY_OR_OTHER||Vaccine efficacy|100.0||||0.0072|TWO_SIDED|95.0|32.3|100.0|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||100|32.3|0.0072
73943129|NCT00834106|147419021|SUPERIORITY_OR_OTHER||Vaccine efficacy|91.8|||||TWO_SIDED|95.0|79.8|97.4|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\].|||97.4|79.8|
73943130|NCT00834106|147419022|SUPERIORITY_OR_OTHER||Vaccine efficacy|93.2|||||TWO_SIDED|95.0|72.9|99.2|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\].|||99.2|72.9|
73943131|NCT03595332|147419030|EQUIVALENCE|The analysis tests whether for both groups combined, the baseline to 10-week follow-up BMI percentile scores are significantly different from zero.|Mean Difference (Final Values)|1.137|STANDARD_ERROR_OF_MEAN|0.9846||0.248|TWO_SIDED|95.0|-0.793|3.067||This test compares baseline to 10-week post-test for both groups combined, to test the null hypothesis that the BMI Percentile score would not be different from zero. A p-value of 0.05 was used as a priori threshold for statistical significance.|Regression, Linear|Linear regression with Generalized Estimating Equations to account for nested data structure of 222 children nested within 150 families and 4 schools.||||3.067|-0.793|0.248
73943132|NCT03595332|147419031|EQUIVALENCE|Analysis tested whether BMI Percentile score change among overweight participants (BMI equal or greater than 85th percentile at baseline) significantly changed from baseline to follow-up (was significantly different from zero). This was a subset analysis among the highest risk participants in the study.|Mean Difference (Final Values)|-3.173|STANDARD_ERROR_OF_MEAN|1.34||0.018|TWO_SIDED|95.0|-5.806|-0.541||The p-value threshold was 0.05 for all comparisons.|Regression, Linear|Linear regression with Generalized Estimating Equations to account for nested data structure of children within schools and families.|A negative parameter suggests a decreased BMI Percentile.|||-0.541|-5.806|0.018
73943133|NCT03595332|147419032|EQUIVALENCE|Analysis tested the difference in BMI percentile between baseline and 1-year follow-up among participants in the immediate intervention group to test the null hypothesis that no change occurred.|Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|1.676||0.829|TWO_SIDED|95.0|-2.922|3.648||A prior threshold for statistical significance was 0.05. No adjustment for multiple comparisons was made.|Regression, Linear|Analysis included Generalized Estimating Equations with linear response variable, accounting for nested data structure.||||3.648|-2.922|0.829
73943134|NCT03595332|147419033|EQUIVALENCE|Analysis test whether for both groups combined, Baseline to 10-week change in reported intention of physical activity was significantly different from zero.|Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.128||0.026|TWO_SIDED|95.0|0.034|0.534||A priori threshold for statistical significance is 0.05. No adjustments for multiple comparisons were made.|Regression, Linear|Linear regression models with Generalized Estimating Equations to account for nested data were made.|A positive parameter would suggest an increase in intentions to be physically active.|||0.534|0.034|0.026
73943135|NCT02227875|147419034|NON_INFERIORITY|Mixed-Effect Model for Repeated Measures|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.098|0.218||||||||0.218|-0.098|
73943136|NCT00166296|147419057|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.441|TWO_SIDED|95.0|0.075|2.141|||Fisher Exact|||||2.141|0.075|0.441
73943137|NCT00166296|147419058|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
73943138|NCT00166296|147419059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.443||95.0|||||ANOVA|||||||0.443
73943139|NCT00166296|147419060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0|||||ANOVA|||||||0.930
73943140|NCT03477279|147419061|SUPERIORITY||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-5.6|7.3|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||7.3|-5.6|
73975144|NCT02307682|147496008|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-7.9|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.2|-7.9|
73943141|NCT03477279|147419062|SUPERIORITY||Risk Difference (RD)|6.6|||||TWO_SIDED|95.0|-0.8|14.0|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||14.0|-0.8|
73943142|NCT03477279|147419063|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|-1.7|21.7|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||21.7|-1.7|
73943143|NCT03477279|147419064|SUPERIORITY||Risk Difference (RD)|16.6|||||TWO_SIDED|95.0|0.9|32.3|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||32.3|0.9|
73943144|NCT03477279|147419065|SUPERIORITY||Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-1.6|31.8||||||||31.8|-1.6|
73975145|NCT02307682|147496008|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-4.5|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||9.2|-4.5|
73943145|NCT03477279|147419066|SUPERIORITY||Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-13.2|8.5|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||8.5|-13.2|
73943146|NCT03477279|147419067|SUPERIORITY||Risk Difference (RD)|-4.5|||||TWO_SIDED|95.0|-10.0|10.7|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||10.7|-10.0|
73943147|NCT03477279|147419068|OTHER||Odds Ratio (OR)|4.9|||||TWO_SIDED|95.0|1.7|13.9||||||||13.9|1.7|
73943148|NCT00406133|147419100|SUPERIORITY_OR_OTHER|||||||0.29||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age 8-14 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||The study was to test whether the use of CGM will lower A1c at 26 weeks. The estimated sample size was 110 for each age group, which will provide 90% power to detect a difference between treatment groups in each of the age groups assuming a population difference of 0.5%, a two-tailed test with type I error rate of 5%, standard deviation of the 6 month HbA1c values of 0.9, correlation between baseline and 26-week values of 0.58.||||0.29
73975146|NCT02307682|147496008|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.8|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.1|-6.8|
74091664|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.27|1.86|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 11A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.86|1.27|<0.001
73943149|NCT00406133|147419100|SUPERIORITY_OR_OTHER|||||||0.52||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value for age 15-24 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||||||0.52
73943150|NCT00406133|147419100|SUPERIORITY_OR_OTHER||||||<|0.001||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age \>=25 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||||||<0.001
73943151|NCT00406133|147419101|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value was for the comparison of RT-CGM group and Control group.|ANCOVA|Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||A sample size of 120 subjects was planned to have 90% power to detect a difference in this outcome between treatment groups, assuming a population difference of 29 min/day, standard deviation of the 26-week values of 59 min/day, correlation between baseline and 26-week values of 0.66, an α=0.05, and no more than 15% losses to follow-up.||||0.16
73943152|NCT00406133|147419102|SUPERIORITY_OR_OTHER|||||||0.74||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.74
73943153|NCT00406133|147419102|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the 15-24 year age group.|Fisher Exact|||||||0.48
73943154|NCT00406133|147419102|SUPERIORITY_OR_OTHER|||||||1||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the \>=25 year age group.|Fisher Exact|||||||1.0
73943155|NCT00406133|147419102|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.74
73943156|NCT00406133|147419102|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 15-24 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.48
73943157|NCT00406133|147419102|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the \>=25 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||1.0
73943158|NCT00406133|147419103|SUPERIORITY_OR_OTHER|||||||0.53||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.53
73943159|NCT00406133|147419103|SUPERIORITY_OR_OTHER|||||||0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.79
73943160|NCT00406133|147419103|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|||||||<0.001
73943161|NCT00406133|147419104|SUPERIORITY_OR_OTHER|||||||0.58||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.58
73943162|NCT00406133|147419104|SUPERIORITY_OR_OTHER|||||||0.85||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.85
73975147|NCT02307682|147496008|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.8|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.4|-5.8|
73943163|NCT00406133|147419104|SUPERIORITY_OR_OTHER|||||||0.002||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.002
73943164|NCT00406133|147419105|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.18
73943165|NCT00406133|147419105|SUPERIORITY_OR_OTHER|||||||0.44||||||P-value for the comparison of treatment groups at 26wks adjusting for the baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.44
73943166|NCT00406133|147419105|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||<0.001
73943167|NCT00406133|147419106|SUPERIORITY_OR_OTHER|||||||0.29||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.29
73943168|NCT00406133|147419106|SUPERIORITY_OR_OTHER|||||||0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.79
73943169|NCT00406133|147419106|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.41
73943170|NCT00406133|147419107|SUPERIORITY_OR_OTHER|||||||0.5||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.50
73943171|NCT00406133|147419107|SUPERIORITY_OR_OTHER|||||||0.99||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.99
73943172|NCT00406133|147419107|SUPERIORITY_OR_OTHER|||||||0.1||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.10
73943173|NCT00406133|147419108|SUPERIORITY_OR_OTHER|||||||0.66||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Glucose variability was assessed by computing the absolute rate of change.||||0.66
73975148|NCT02307682|147496008|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-6.1|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||8.2|-6.1|
74089235|NCT02697773|147731602|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0129|TWO_SIDED|95.0|-1.07|-0.13||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.13|-1.07|0.0129
73975149|NCT02307682|147496008|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.6|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.6|-8.6|
73975150|NCT02307682|147496008|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.0|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||7.1|-7.0|
74091665|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|2.3|||<|0.001|TWO_SIDED|95.0|1.75|3.04|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 12F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.04|1.75|<0.001
73943174|NCT00406133|147419108|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.48
73943175|NCT00406133|147419108|SUPERIORITY_OR_OTHER|||||||0.07||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.07
73943176|NCT00406133|147419109|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|Adjusted for baseline A1c and clinical center.||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center).||||<0.001
73943177|NCT00406133|147419110|SUPERIORITY_OR_OTHER||||||<|0.001||||||Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.|ANCOVA|Adjusted for baseline value, clinical center and type of continuous glucose monitor.||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||<0.001
73943178|NCT00406133|147419111|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.03
73943179|NCT00406133|147419112|SUPERIORITY_OR_OTHER|||||||0.04||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.04
73943180|NCT00406133|147419112|SUPERIORITY_OR_OTHER|||||||0.46||||||P-value for the 15-24 year age group|Regression, Logistic|||||||0.46
73943181|NCT00406133|147419112|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value for the \>=25 year age group|Regression, Logistic|||||||0.003
73975151|NCT02307682|147496008|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-3.5|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||11.0|-3.5|
73975152|NCT02307682|147496008|OTHER||Difference in proportions|4.0|||||TWO_SIDED|95.0|-3.0|10.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||10.8|-3.0|
73943182|NCT00406133|147419113|SUPERIORITY_OR_OTHER|||||||0.24||||||P-value for 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.24
73943183|NCT00406133|147419113|SUPERIORITY_OR_OTHER|||||||0.98||||||P-value for the 15-24 year old age group|Regression, Logistic|||||||0.98
73943184|NCT00406133|147419113|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||0.48
73943185|NCT00406133|147419114|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value representative of 13 and 26 weeks combined|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.005
73943186|NCT00406133|147419115|SUPERIORITY_OR_OTHER|||||||0.05||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.05
73943187|NCT00406133|147419116|SUPERIORITY_OR_OTHER|||||||0.39||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Glucose variability was assessed by computing the absolute rate of change.||||0.39
73943188|NCT00406133|147419117|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Nominal p-value not adjusted for multiple comparisons|ANCOVA|||||||0.04
73943189|NCT00406133|147419118|SUPERIORITY_OR_OTHER||Ratio of treatment differences|408148.0|||||TWO_SIDED|95.0|-176644.0|3475108.0||||||"ICER = Incremental Cost Effectiveness Ratio is defined as the mean difference in costs between the treatment groups divided by the mean difference in QALY (quality-adjusted life-year) between the treatment groups:~(mean cost\[CGM\] - mean cost \[control\]) / (mean QALY\[CGM\] - mean QALY\[SMBG\]).~Units are dollars per QALY."||3475108|-176644|
73943190|NCT00406133|147419119|SUPERIORITY_OR_OTHER|||||||0.009||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.009
73943191|NCT00406133|147419119|SUPERIORITY_OR_OTHER|||||||0.57||||||P-value for 15-24 year old age group|Regression, Logistic|||||||0.57
73943192|NCT00406133|147419119|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||<0.001
73975153|NCT02307682|147496008|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|-1.4|13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||13.0|-1.4|
73975154|NCT02307682|147496008|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-4.1|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.5|-4.1|
73975155|NCT02307682|147496008|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.8|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.7|-4.8|
73975156|NCT02307682|147496008|OTHER||Difference in proportions|5.2|||||TWO_SIDED|95.0|-1.6|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||12.3|-1.6|
74091666|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.82|||<|0.001|TWO_SIDED|95.0|1.49|2.22|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 17F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.22|1.49|<0.001
73869193|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.81|1.12||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.12|0.81|
73869194|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.81|1.21||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.21|0.81|
73943193|NCT00406133|147419120|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.18
73943194|NCT00406133|147419120|SUPERIORITY_OR_OTHER|||||||0.84||||||P-value for 15-24 year old age group.|Regression, Logistic|||||||0.84
73975157|NCT02307682|147496008|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-5.4|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||8.6|-5.4|
74031375|NCT05022004|147616172|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.59|0.5|||||The reported mean difference represents value for Left Eye at Week 6, 08:00am|||0.50|-0.59|
73943195|NCT00406133|147419120|SUPERIORITY_OR_OTHER|||||||0.02||||||P-value for \>=25 year old age group.|Regression, Logistic|||||||0.02
73943196|NCT00406133|147419121|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.01
73975158|NCT02307682|147496008|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.8|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||9.4|-4.8|
74031376|NCT05022004|147616172|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.64|0.4|||||The reported mean difference represents value for Right Eye at Week 6, 08:00am|||0.40|-0.64|
74031377|NCT05022004|147616173|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed||||||0.0015||||||P value reported for Left Eye at Week 2; 08:00 am|two-sample t-test|||||||0.0015
74031378|NCT05022004|147616173|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed||||||0.0008|||||||two-sample t-test|P value reported for Right Eye at Week 2; 08:00am||||||0.0008
74031379|NCT05022004|147616173|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|||||<|0.0001|||||||two-sample t-test|P value reported for left eye at week 6, 08:00 am||||||<.0001
74031380|NCT05022004|147616173|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|||||<|0.0001|||||||two-sample t-test|P value reported for Right eye at Week 6; 08:00 am||||||<.0001
73943197|NCT00406133|147419121|SUPERIORITY_OR_OTHER|||||||0.8||||||P-value for 14-24 year age group|Regression, Logistic|||||||0.80
73943198|NCT00406133|147419121|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value for \>=25 year age group|Regression, Logistic|||||||0.005
73943199|NCT00406133|147419122|SUPERIORITY_OR_OTHER|||||||0.02||||||P-value for the 8-14 year age group|Regression, Logistic|||A post-hoc defined binary outcome of 26-week glycated hemoglobin \<7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.02
73943200|NCT00406133|147419122|SUPERIORITY_OR_OTHER|||||||0.67||||||P-value for the 15-24 year old age group|Regression, Logistic|||||||0.67
73943201|NCT00406133|147419122|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||0.006
73943202|NCT00406133|147419123|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||<0.001
74031381|NCT00374907|147616214|SUPERIORITY_OR_OTHER||Adjusted Percent Difference|18.5||||0.035|TWO_SIDED|95.0|1.3|38.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment|||38.7|1.3|0.0350
73943203|NCT00406133|147419124|SUPERIORITY_OR_OTHER|||||||0.002|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||0.002
73943204|NCT00406133|147419125|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||<0.001
73943205|NCT03088267|147419158|SUPERIORITY||Mean Difference (Final Values)|-8.6||||0.0118|TWO_SIDED|95.0|-14.94|-2.17|||ANCOVA|||||-2.17|-14.94|0.0118
73943206|NCT03088267|147419159|SUPERIORITY||Mean Difference (Final Values)|18.8||||0.1128|TWO_SIDED|95.0|-4.94|42.5|||ANCOVA|||Comparison at 30 minutes post-dose||42.50|-4.94|0.1128
73943207|NCT03088267|147419159|SUPERIORITY||Mean Difference (Final Values)|60.3||||0.0003|TWO_SIDED|95.0|32.91|87.75|||ANCOVA|||Comparison at 3 hours postdose||87.75|32.91|0.0003
74031382|NCT00374907|147616215|SUPERIORITY_OR_OTHER||Adjusted Percent Difference|27.9||||0.0204|TWO_SIDED|95.0|4.2|57.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment|||57.1|4.2|0.0204
74031383|NCT01323673|147616279|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||Cochran-Mantel-Haenszel (CMH) test stratified by center was used for analysis.|Cochran-Mantel-Haenszel|||||||0.151
73943208|NCT00724152|147419186|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Null hypothesis: The Cognitive Behavioral Therapy group would not demonstrate decreased distress at post-treatment as compared to the Tinnitus Education group on the primary outcome measure (THI) between pre-treatment and post-treatment.||||<0.05
73943209|NCT00386022|147419189|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the LH response to GnRH as a function of dose in young or old postmenopausal women|||||<|0.001||||||LH % change with dose|Repeated measures ANCOVA|||||||<0.001
73943210|NCT00386022|147419189|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the LH response to GnRH between younger and older postmenopausal women|||||<|0.03||||||LH % change with age|Repeated measures ANCOVA|||null hypothesis: there will be no difference in the LH and FSH responses to graded doses of GnRH between younger and older postmenopausal women||||<0.03
73943211|NCT00386022|147419189|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the FSH response to GnRH as a function of dose in younger or older postmenopausal women|||||<|0.001||||||FSH % change with dose|Repeated measures ANCOVA|||||||<0.001
73943212|NCT00386022|147419189|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the FSH response to GnRH between young and old postmenopausal women|||||<|0.005||||||FSH % change with age|Repeated measures ANCOVA|||||||<0.005
74031384|NCT04598165|147616287|SUPERIORITY||Risk Ratio (RR)|1.25||||0.314|TWO_SIDED|95.0|0.81|1.92||The primary intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.||1.92|0.81|0.314
74039445|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0008|TWO_SIDED|95.0|-0.76|-0.2|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.20|-0.76|0.0008
73869195|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.72|1.16||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.16|0.72|
73869196|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.19|||||TWO_SIDED|95.0|1.0|1.4||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.40|1.00|
73869197|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.36|0.91|
73869198|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.29|||||TWO_SIDED|95.0|1.03|1.6||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.60|1.03|
73869199|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.33||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.33|0.88|
73869200|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.91|1.46||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.46|0.91|
73869201|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.12|||||TWO_SIDED|95.0|0.87|1.43||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.43|0.87|
73943213|NCT00386022|147419190|EQUIVALENCE|null hypothesis will be accepted if there is no effect of estrogen on the LH response to GnRH in younger and older postmenopausal women|||||<|0.01||||||LH amplitude response with estrogen|Repeated measured ANCOVA|||||||<0.01
73943214|NCT00386022|147419190|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of estrogen on the FSH response to GnRH in younger and older postmenopausal women|||||<|0.0001||||||FSH amplitude response with estrogen|Repeated measures ANCOVA|||||||<0.0001
73943215|NCT00386022|147419190|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the FSH response to GnRH|||||<|0.02||||||FSH amplitude response to estrogen with age|Repeated measures ANCOVA|||||||<0.02
73943216|NCT00386022|147419190|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the LH response to GnRH|||||=|0.4||||||LH amplitude response to estrogen with age|Repeated measures ANCOVA|||||||=0.4
73943217|NCT05168579|147419241|SUPERIORITY||Odds Ratio (OR)|13.8|||<|0.001|TWO_SIDED|95.0|2.76|69.6|||Mixed Models Analysis|||||69.6|2.76|<0.001
73943218|NCT00106184|147419259|SUPERIORITY_OR_OTHER||||||=|0.74|TWO_SIDED||||||Log Rank|No confidence intervals as no parameters were estimated.||Proportional hazards model||||=0.74
73869202|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.30|0.83|
73869203|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.21|||||TWO_SIDED|95.0|1.01|1.46||||||Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.46|1.01|
73869204|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.26|0.96|
73869205|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.22|0.82|
73869206|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.89|1.31||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.31|0.89|
73869207|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.4|||||TWO_SIDED|95.0|1.16|1.69||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.69|1.16|
73869208|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.94|1.35||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.35|0.94|
73869209|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.97|||||TWO_SIDED|95.0|0.81|1.16||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.16|0.81|
73943219|NCT00106184|147419260|SUPERIORITY_OR_OTHER||||||>|0.9|TWO_SIDED|95.0|||||Chi-squared|Difference in baseline muscle enzymes therefore tested the difference in the proportions adjusting for the baseline values.||||||>0.90
73943220|NCT00106184|147419261|SUPERIORITY_OR_OTHER||||||>|0.9|||||||Log Rank|||||||>0.90
73943221|NCT02313909|147419262|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.51884|TWO_SIDED|95.0|0.87|1.33|||Log Rank|||Statistical analysis: Stroke + Systemic embolism: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.33|0.87|0.51884
73869210|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.25|0.87|
73869211|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.12|||||TWO_SIDED|95.0|0.94|1.33||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.33|0.94|
73869212|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.75|1.13||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.13|0.75|
73869213|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.2||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.20|0.86|
73869214|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.17|0.78|
73869215|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.78|1.25||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.25|0.78|
73869216|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.16|0.83|
73943222|NCT02313909|147419263|SUPERIORITY||Hazard Ratio (HR)|2.72||||2e-05|TWO_SIDED|95.0|1.68|4.39|||Log Rank|||Statistical analysis: ISTH major bleeding events: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.39|1.68|0.00002
73943223|NCT02313909|147419264|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.56922|TWO_SIDED|95.0|0.87|1.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.29|0.87|0.56922
73943224|NCT02313909|147419265|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.22078|TWO_SIDED|95.0|0.87|1.81|||Log Rank|||Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.81|0.87|0.22078
74039446|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.96|-0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.39|-0.96|<.0001
73869217|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.87|1.3||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.30|0.87|
73869218|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.8|1.24||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.24|0.80|
73869219|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.94|1.42||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.42|0.94|
73869220|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.82|1.33||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.33|0.82|
73869221|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.77|1.26||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.26|0.77|
73869222|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.82|1.29||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.29|0.82|
73869223|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.89|1.28||||||Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.28|0.89|
73869224|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.09|||||TWO_SIDED|95.0|0.95|1.24||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.95|
73943225|NCT02313909|147419266|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4797|TWO_SIDED|95.0|0.87|1.34|||Log Rank|||Statistical analysis 1: Stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.34|0.87|0.47970
73943226|NCT02313909|147419266|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.78738|TWO_SIDED|95.0|0.83|1.29|||Log Rank|||Statistical analysis 2: Ischemic stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.29|0.83|0.78738
73943227|NCT02313909|147419266|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.14822|TWO_SIDED|95.0|0.88|2.28|||Log Rank|||Statistical analysis 3: Disabling stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.28|0.88|0.14822
73943228|NCT02313909|147419266|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.14051|TWO_SIDED|95.0|0.87|2.52|||Log Rank|||Statistical analysis 4:CV death: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.52|0.87|0.14051
73943229|NCT02313909|147419266|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.34284|TWO_SIDED|95.0|0.39|1.38|||Log Rank|||Statistical analysis 5: Myocardial infarction: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.38|0.39|0.34284
73943230|NCT02313909|147419267|SUPERIORITY||Hazard Ratio (HR)|2.34||||0.00443|TWO_SIDED|95.0|1.28|4.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.29|1.28|0.00443
73943231|NCT02313909|147419268|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.00451|TWO_SIDED|95.0|1.13|2.0|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.00|1.13|0.00451
73943232|NCT02313909|147419269|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.04409|TWO_SIDED|95.0|1.0|4.02|||Log Rank|||Statistical analysis 1: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.02|1.00|0.04409
73943233|NCT01446666|147419275|SUPERIORITY||||||<|0.01|||||||McNemar|||The HCC detection rate was defined as the number of patients with HCC detected by a given modality divided by the total number of patients with HCC detected by all modalities and by follow-up dynamic CT scan. The HCC detection rates from ultrasonography and MRI were compared.||||<0.01
73943234|NCT01446666|147419276|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
73943235|NCT01446666|147419277|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
73943236|NCT01446666|147419278|SUPERIORITY|||||||0.004|||||||McNemar|||||||0.004
73943237|NCT02231177|147419280|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12|STANDARD_DEVIATION|32.15|||TWO_SIDED|90.0|0.99|1.27|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.27|0.99|
73943238|NCT02231177|147419281|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11|STANDARD_DEVIATION|27.17|||TWO_SIDED|90.0|1.01|1.22|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.22|1.01|
73943239|NCT02231177|147419282|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.98|STANDARD_DEVIATION|20.43|||TWO_SIDED|90.0|0.91|1.06|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.||1.06|0.91|
73943240|NCT02231177|147419283|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.05|STANDARD_DEVIATION|19.85|||TWO_SIDED|90.0|0.98|1.13|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.13|0.98|
73943241|NCT02231177|147419284|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|STANDARD_DEVIATION|19.81|||TWO_SIDED|90.0|0.83|0.98|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.||0.98|0.83|
73869225|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.85|1.27||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.27|0.85|
73975159|NCT02307682|147496008|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-5.0|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.2|-5.0|
73975160|NCT02307682|147496008|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.9|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||7.4|-6.9|
73975161|NCT02307682|147496008|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.1|8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.5|-5.1|
73975162|NCT02307682|147496008|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-3.9|10.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||10.1|-3.9|
73869226|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.41||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.41|0.96|
73869227|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.93|1.36||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.36|0.93|
73975163|NCT02307682|147496008|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-5.0|9.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.1|-5.0|
73975164|NCT02307682|147496008|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-2.5|11.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||11.8|-2.5|
73975165|NCT02307682|147496008|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.4|10.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||10.6|-3.4|
73975166|NCT02307682|147496008|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.6|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||12.2|-1.6|
73975167|NCT02307682|147496008|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-3.0|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||11.2|-3.0|
73869228|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.33|0.93|
73975168|NCT02307682|147496008|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-1.9|12.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.7|-1.9|
73975169|NCT02307682|147496008|OTHER||Difference in proportions|5.7|||||TWO_SIDED|95.0|-1.0|12.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.6|-1.0|
73975170|NCT02307682|147496009|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-7.7|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.0|-7.7|
73869229|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.83|1.19||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.19|0.83|
73869230|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.78|1.12||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.12|0.78|
73869231|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.24||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.88|
73869232|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.86|1.29||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.29|0.86|
73869233|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.25||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.25|0.91|
73943242|NCT02231177|147419285|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.96|STANDARD_DEVIATION|29.92|||TWO_SIDED|90.0|0.87|1.07|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.||1.07|0.87|
73943243|NCT02231177|147419286|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.02|STANDARD_DEVIATION|21.33|||TWO_SIDED|90.0|0.93|1.12|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg : Olodaterol 10 µg). No formal testing.||1.12|0.93|
73943244|NCT02231177|147419287|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91|STANDARD_DEVIATION|22.61|||TWO_SIDED|90.0|0.84|1.0|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.||1.00|0.84|
73943245|NCT02231177|147419288|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.32|STANDARD_DEVIATION|96.12|||TWO_SIDED|90.0|0.98|1.77|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg; Olodaterol 10 µg). No formal testing.||1.77|0.98|
73943246|NCT02231177|147419289|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99|STANDARD_DEVIATION|72.08|||TWO_SIDED|90.0|0.79|1.24|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg; Tiotropium 5 µg). No formal testing.||1.24|0.79|
73943247|NCT00409682|147419303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.29||||0.075|TWO_SIDED|95.0|-3.14|23.71||There is no adjustment for multiple comparison on the primary outcome measure.|Cochran-Mantel-Haenszel||Difference is between adalimumab High-dose and adalimumab Low-dose group.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The P value is from the CMH test adjusted for infliximab use and response status at Week 4. The primary analysis was performed for the intent-to-treat (ITT) using the non-responder (NRI) imputation method.||23.71|-3.14|0.075
73943248|NCT00409682|147419304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.18||||0.1|TWO_SIDED|95.0|-2.62|22.97||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% CIs for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||22.97|-2.62|0.100
73975171|NCT02307682|147496009|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.3|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||8.7|-5.3|
73975172|NCT02307682|147496009|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.4|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.8|-7.4|
73975173|NCT02307682|147496009|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-8.9|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||5.3|-8.9|
73975174|NCT02307682|147496009|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-8.1|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.9|-8.1|
73869234|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.79|1.17||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.17|0.79|
73869235|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.85|1.37||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.37|0.85|
73943249|NCT00409682|147419305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.72||||0.073|TWO_SIDED|95.0|-3.45|24.89||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||24.89|-3.45|0.073
73943250|NCT00409682|147419306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.51||||0.038|TWO_SIDED|95.0|-0.01|27.04||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||27.04|-0.01|0.038
73943251|NCT00409682|147419307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|2.903||0.161|TWO_SIDED|95.0|-9.86|1.66||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|"Analyzed as change from Baseline to Week 26, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% CI for the treatment difference were provided. Analysis was conducted in the ITT population for OC.~The P value is from the ANCOVA model with treatment as a factor, adjusted for the baseline value, and the strata (response status at Week 4 and prior infliximab experience)."||1.66|-9.86|0.161
73943252|NCT00409682|147419308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|2.941||0.735|TWO_SIDED|95.0|-6.88|4.88|||ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|Analyzed as change from Baseline to Week 52, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% confidence interval (CI) for the treatment difference were provided. Analysis was conducted in the ITT population for OC.||4.88|-6.88|0.735
73943253|NCT00252538|147419344|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||All statistics employed Statistical Package for Social Science (SPSS) 17.0. Analysis of variances were used to compare viral responses in genotypes of interest, employing Scheffe's post-hoc analyses. Repeated-measure mixed-effect analyses were used to compare changes in subjective symptoms over time, including age, gender, and self identified race as covariates. Kaplan-Meier survival analyses examining time until MDD development were compared using theMantel-Cox log rank test.||||>0.05
73943254|NCT00118716|147419347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|STANDARD_ERROR_OF_MEAN|1.29||0.021|TWO_SIDED|95.0|0.5|5.6||LS Mean Difference, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for maximal percent change in FEV1 following exercise challenge at Week 4.||5.6|0.5|0.021
73943255|NCT00118716|147419348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|0.24|0.58||LS Mean Diff, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for post-dose FEV1 AUC Day 1.||0.58|0.24|<0.001
73975175|NCT02307682|147496009|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.8|8.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||8.8|-4.8|
73975176|NCT02307682|147496009|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-9.8|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.7|-9.8|
73975177|NCT02307682|147496009|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-5.3|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.6|-5.3|
73975178|NCT02307682|147496009|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.6|-9.7|
73975179|NCT02307682|147496009|OTHER||Difference in proportions|-4.1|||||TWO_SIDED|95.0|-11.4|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-11.4|
73975180|NCT02307682|147496009|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-7.6|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.1|-7.6|
73943256|NCT00118716|147419349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.1|STANDARD_ERROR_OF_MEAN|4.83||0.097|TWO_SIDED|95.0|-1.5|17.6||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for AM PEF||17.6|-1.5|0.097
73975181|NCT02307682|147496009|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.4|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||10.0|-4.4|
73943257|NCT00118716|147419350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|4.3||0.396|TWO_SIDED|95.0|-4.8|12.1||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID PM PEF.||12.1|-4.8|0.396
73943258|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.129||0.168|TWO_SIDED|95.0|-0.08|0.43||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 2||0.43|-0.08|0.168
73943259|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.147||0.465|TWO_SIDED|95.0|-0.18|0.4||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 4.||0.40|-0.18|0.465
73943260|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.133||0.222|TWO_SIDED|95.0|-0.1|0.42||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Endpoint.||0.42|-0.10|0.222
73943261|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.096||0.294|TWO_SIDED|95.0|-0.29|0.09||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 2.||0.09|-0.29|0.294
73943262|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.111||0.828|TWO_SIDED|95.0|-0.24|0.19||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 4.||0.19|-0.24|0.828
73943263|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.103||0.903|TWO_SIDED|95.0|-0.19|0.22||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Endpoint.||0.22|-0.19|0.903
73943264|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.112||0.464|TWO_SIDED|95.0|-0.3|0.14|||ANCOVA|LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 2.||0.14|-0.30|0.464
73943265|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.124||0.551|TWO_SIDED|95.0|-0.32|0.17||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 4.||0.17|-0.32|0.551
73943266|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.123||0.633|TWO_SIDED|95.0|-0.3|0.18||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Endpoint.||0.18|-0.30|0.633
73975182|NCT02307682|147496009|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-7.2|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.9|-7.2|
74039447|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.0711|TWO_SIDED|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.02|-0.50|0.0711
73869236|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||0.98|0.70|
73943267|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.094||0.7|TWO_SIDED|95.0|-0.22|0.15||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 2.||0.15|-0.22|0.700
73975183|NCT02307682|147496009|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-6.3|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.8|-6.3|
73975184|NCT02307682|147496009|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.7|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||9.2|-4.7|
73975185|NCT02307682|147496009|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-3.9|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||10.3|-3.9|
73975186|NCT02307682|147496009|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-12.6|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.3|-12.6|
73943268|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.109||0.86|TWO_SIDED|95.0|-0.23|0.2||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 4.||0.20|-0.23|0.860
73943269|NCT00118716|147419353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.103||0.919|TWO_SIDED|95.0|-0.19|0.21||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Endpoint.||0.21|-0.19|0.919
73943270|NCT02436811|147419356|SUPERIORITY_OR_OTHER||||||<|0.001||||||A stepwise forward selection model was used. All independent variables with P\<0.20 in the univariate analysis were selected and those which were significant (P\<0.05) were kept in the final model. The level of significance was 5%.|Regression, Poisson|||Univariate and multivariate Poisson regressions with robust variance were obtained to estimate the rate ratios (RR) and their respective 95% confidence intervals. Two Poisson regression models were generated, using the knowledge score 15 minutes after the intervention (post-test) and 4 weeks after the interventions (follow-up test) as dependent variables.||||<0.001
73943271|NCT02657317|147419376|SUPERIORITY||Mean Difference (Final Values)|-9.1||||0.001|TWO_SIDED|95.0|-14.4|-3.7|||GLMM|||To detect a medium effect (d = 0.50) at 2-sided α = 0.05, 50 participants were needed in each study arm (total N = 100). We anticipated 30% attrition in each arm. Data for the primary aim were analyzed using generalized linear mixed models adjusting for baseline levels of prognostic variable and using random intercepts at the level of participants. The primary analysis was based on intent-to-treat.||-3.7|-14.4|.001
73943272|NCT02856113|147419377|SUPERIORITY||Least Square (LS) Mean Difference|0.102|STANDARD_DEVIATION|0.3677|=|0.782|TWO_SIDED|95.0|-0.627|0.831||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|||0.831|-0.627|=0.782
73943273|NCT02856113|147419378|SUPERIORITY||LS Mean Difference|-0.046|STANDARD_DEVIATION|0.2635|=|0.863|TWO_SIDED|95.0|-0.567|0.476||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 12||0.476|-0.567|=0.863
73943274|NCT02856113|147419378|SUPERIORITY||LS Mean Difference|0.004|STANDARD_DEVIATION|0.3123|=|0.99|TWO_SIDED|95.0|-0.614|0.622||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 18||0.622|-0.614|=0.990
73943275|NCT02856113|147419378|SUPERIORITY||LS Mean Difference|-0.412|STANDARD_DEVIATION|0.3664|=|0.264|TWO_SIDED|95.0|-1.139|0.316||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 39||0.316|-1.139|=0.264
73943276|NCT02856113|147419378|SUPERIORITY||LS Mean Difference|-0.483|STANDARD_DEVIATION|0.4165|=|0.25|TWO_SIDED|95.0|-1.314|0.348||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 52||0.348|-1.314|=0.250
73975187|NCT02307682|147496009|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-12.7|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.9|-12.7|
73975188|NCT02307682|147496009|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-8.1|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-8.1|
73975189|NCT02307682|147496009|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-6.2|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||7.9|-6.2|
73975190|NCT02307682|147496009|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.9|-9.6|
73975191|NCT02307682|147496009|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-9.1|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.4|-9.1|
73943277|NCT03494166|147419389|SUPERIORITY|Key parameter was the coefficient for the trial arm variable in the mixed model, reflecting average difference of group means over time (weeks 1-13).|Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|1.32||0.31|TWO_SIDED|95.0|-3.9|1.25||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was set at .05.|Mixed Models Analysis|Linear mixed effects models were used for 13 repeated measures of symptom severity index, adjusting for baseline value.|The mean of the group that started with SMSH alone minus the mean of the group that started with SMSH+TIPC (average over time).|"The null hypothesis was that the means in two arms were equal, the alternative hypothesis was that the means were not equal.~We planned to randomize 224 survivors in approximately 3:1 ratio in the first randomization; power was 0.92 to detect the adjusted d=0.54 in the comparison of the SMSH and SMSH+TIPC in the first randomization. The planned number of 224 was exceeded because more survivors than planned were determined to have high need for symptom management."||1.25|-3.90|.31
73943278|NCT03494166|147419390|SUPERIORITY|The key parameter was the coefficient for the variable reflecting trial arm from the second randomization in the mixed model. This parameter reflected average difference between means of two groups over time (weeks 5-13).|Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|3.35||0.52|TWO_SIDED|95.0|-8.91|4.55||The p-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Linear mixed effects models were used for 9 repeated measures of symptom severity index (weeks 5-13), adjusting for baseline value.|The mean of the group that continued with SMSH alone minus the mean of the group that had TIPC added to the SMSH after week 4.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The required sample size was 60 per group for .80 power or greater in two-tailed tests at the 0.05 level of significance using the effect size of Cohen's d=0.54 (adjusted for baseline and repeated measures). The actual sample size was smaller (61 total) due to the higher than planned rate of response to the SMSH alone by week 4.||4.55|-8.91|.52
73943279|NCT03494166|147419391|SUPERIORITY|Key parameter was the coefficient for the trial arm from the first randomization variable in the linear regression model.|Median Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.12||0.71|TWO_SIDED|95.0|-2.63|1.81||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear||The mean of group that started with SMSH alone minus the mean of the group that started with SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.81|-2.63|.71
73975192|NCT02307682|147496009|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.1|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.1|-11.1|
73975193|NCT02307682|147496009|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.5|-10.4|
73943280|NCT03494166|147419392|SUPERIORITY|The key parameter was the coefficient for the trial arm from the second randomization variable in linear regression model.|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|2.91||0.79|TWO_SIDED|95.0|-6.53|5.01||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear|The model included the adjustment for baseline value of the outcome.|The mean of the group that continued with SMSH alone minus the mean of the group that had TIPC added to the SMSH after week 4.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||5.01|-6.53|.79
73943281|NCT00855595|147419421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0903|||||||ANCOVA|||||||0.0903
73943282|NCT01542957|147419501|SUPERIORITY_OR_OTHER||Slope|-0.96|STANDARD_ERROR_OF_MEAN|0.69||0.6|TWO_SIDED|95.0|-3.35|1.43|||Mixed Models Analysis|||||1.43|-3.35|0.60
73943283|NCT01542957|147419502|SUPERIORITY_OR_OTHER||Slope|1.27|STANDARD_ERROR_OF_MEAN|0.53||0.21|TWO_SIDED|95.0|-0.71|3.25|||Mixed Models Analysis|||||3.25|-0.71|0.21
73943284|NCT01542957|147419503|SUPERIORITY_OR_OTHER||Slope|-0.01||||0.84|TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|||||0.12|-0.14|0.84
73943285|NCT02220894|147419504|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.0|0.58|0.86||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||0.86|0.58|0.0003
73943286|NCT02220894|147419505|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0012|TWO_SIDED|95.0|0.65|0.91||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||0.91|0.65|0.0012
73943287|NCT02220894|147419506|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0013|TWO_SIDED|95.0|0.71|0.93||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||0.93|0.71|0.0013
73943288|NCT02220894|147419507|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.026|TWO_SIDED|95.0|0.69|1.0||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).|||1.00|0.69|0.0260
73943289|NCT02220894|147419508|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2134|TWO_SIDED|95.0|0.8|1.1||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||1.10|0.80|0.2134
73943290|NCT02220894|147419509|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7964|TWO_SIDED|95.0|0.93|1.19||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||1.19|0.93|0.7964
73943291|NCT02220894|147419510|SUPERIORITY||Difference in Percentage (DP)|7.0||||0.0353|TWO_SIDED|95.0|-0.6|14.6||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous).|||14.6|-0.6|0.0353
73943292|NCT02220894|147419511|SUPERIORITY||Difference in Percentage (DP)|4.6||||0.0744|TWO_SIDED|95.0|-1.7|10.9||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||10.9|-1.7|0.0744
73943293|NCT02220894|147419512|SUPERIORITY||Difference in Percentage (DP)|0.6||||0.406|TWO_SIDED|95.0|-4.2|5.4||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||5.4|-4.2|0.4060
73975194|NCT02307682|147496009|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-8.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.7|-8.0|
73975195|NCT02307682|147496009|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-9.7|
73975196|NCT02307682|147496009|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.5|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||7.9|-5.5|
73943294|NCT02532556|147419585|SUPERIORITY||||||<|0.05|||||||Wilcoxan signed-rank test|||||||<0.05
73943295|NCT02532556|147419586|SUPERIORITY||||||<|0.05|||||||Wilcoxan signed-rank test|||||||<0.05
73943296|NCT01648348|147419589|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.57|TWO_SIDED|95.0|0.73|1.77|||Log Rank|||||1.77|0.73|0.57
73943297|NCT01648348|147419590|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73943298|NCT01648348|147419591|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.82|TWO_SIDED|95.0|0.66|1.69|||Log Rank|||||1.69|0.66|0.82
73943299|NCT01648348|147419593|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
73943300|NCT01648348|147419594|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Future uncertainty symptom scale/item t-test, 2-sided, unpooled.||||0.55
73943301|NCT01648348|147419594|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Visual disorder symptom scale/item t-test, 2-sided, unpooled.||||0.16
73943302|NCT01648348|147419594|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Motor dysfunction symptom scale/item t-test, 2-sided, unpooled.||||0.99
73943303|NCT01648348|147419594|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Communication deficit symptom scale/item t-test, 2-sided, unpooled.||||0.75
73943304|NCT01648348|147419594|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Headaches symptom scale/item t-test, 2-sided, unpooled.||||0.17
73943305|NCT01648348|147419594|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Seizures symptom scale/item t-test, 2-sided, unpooled.||||0.90
73943306|NCT01648348|147419594|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Drowsiness symptom scale/item t-test, 2-sided, unpooled.||||0.82
73943307|NCT01648348|147419594|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Itchy skin symptom scale/item t-test, 2-sided, unpooled.||||0.15
73943308|NCT01648348|147419594|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Hair loss symptom scale/item t-test, 2-sided, unpooled.||||0.77
73975197|NCT02307682|147496009|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.5|-7.2|
73975198|NCT02307682|147496009|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.8|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||8.4|-5.8|
73975199|NCT02307682|147496009|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.2|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.9|-7.2|
73975200|NCT02307682|147496009|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-7.9|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.5|-7.9|
73943309|NCT01648348|147419594|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Weakness of legs symptom scale/item t-test, 2-sided, unpooled.||||0.10
73975201|NCT02307682|147496009|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.6|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.9|-6.6|
73943310|NCT01648348|147419594|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||Bladder control symptom scale/item t-test, 2-sided, unpooled.||||0.65
73943311|NCT01648348|147419595|SUPERIORITY|||||||0.83|||||||proportion test|||||||0.83
73943312|NCT00696410|147419599|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||p value represents test of paired (within patient) difference||||0.068
73943313|NCT00696410|147419599|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.022
73943314|NCT00696410|147419600|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|95.0|||||Sign test|||p value represents test of paired (within patient) difference||||0.71
73943315|NCT00696410|147419600|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.33
73943316|NCT00696410|147419601|SUPERIORITY_OR_OTHER|||||||0.69|||||||Sign test|||p value represents test of paired (within patient) difference||||0.69
73943317|NCT00696410|147419601|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.004
73943318|NCT00696410|147419602|SUPERIORITY_OR_OTHER|||||||0.48|||||||Sign test|||p value represents test of paired (within patient) difference||||0.48
73943319|NCT00696410|147419602|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.39
73943320|NCT00696410|147419603|SUPERIORITY_OR_OTHER|||||||0.92|||||||Sign test|||p value represents test of paired (within patient) difference||||0.92
73943321|NCT00696410|147419603|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.22
73943322|NCT01951638|147419604|OTHER||Log-Scale mean difference|0.137|||=|0.8991|TWO_SIDED|90.0|-0.04|0.31|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups BAY1021189 (2.5mg, 2.5 to 5mg, 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test. The Hochberg procedure was used to test the two primary end points at study-wise significance level of 5%. Results are reported including 90% confidence intervals (CI) for the difference of means. The difference between the comparison groups is difference of means on the log scale.||0.31|-0.04|= 0.8991
73943323|NCT01951638|147419604|OTHER||Log-Scale mean difference|0.076|||=|0.7194|TWO_SIDED|95.0|-0.18|0.33|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.33|-0.18|= 0.7194
73943324|NCT01951638|147419604|OTHER||Log-Scale mean difference|0.156|||=|0.8653|TWO_SIDED|95.0|-0.12|0.43|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.43|-0.12|= 0.8653
73943325|NCT01951638|147419604|OTHER||Log-Scale mean difference|0.171|||=|0.9041|TWO_SIDED|95.0|-0.09|0.43|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.43|-0.09|= 0.9041
73943326|NCT01951638|147419604|OTHER||Log-Scale mean difference|0.052|||=|0.6572|TWO_SIDED|95.0|-0.2|0.3|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.3|-0.2|= 0.6572
73943327|NCT01951638|147419605|OTHER||Mean Difference (Net)|1.629|||=|0.8156|TWO_SIDED|90.0|-1.36|4.62|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups (BAY1021189 2.5mg, BAY1021189 2.5 to 5mg, BAY1021189 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test. The Hochberg procedure was used to test the two primary end points at study-wise significance level of 5%. Results are reported including 90% confidence intervals (CI) for the difference of means.||4.62|-1.36|= 0.8156
73943328|NCT01951638|147419605|OTHER||Mean Difference (Net)|1.707|||=|0.7945|TWO_SIDED|95.0|-2.39|5.8|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||5.8|-2.39|= 0.7945
73943329|NCT01951638|147419605|OTHER||Mean Difference (Net)|2.109|||=|0.7917|TWO_SIDED|95.0|-3.01|7.23|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||7.23|-3.01|= 0.7917
73943330|NCT01951638|147419605|OTHER||Mean Difference (Net)|1.219|||=|0.7241|TWO_SIDED|95.0|-2.82|5.26|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||5.26|-2.82|= 0.7241
73943331|NCT01951638|147419605|OTHER||Mean Difference (Net)|1.198|||=|0.7546|TWO_SIDED|95.0|-2.23|4.63|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||4.63|-2.23|= 0.7546
73943332|NCT03017079|147419633|NON_INFERIORITY|a:0.05;β：0.01 P=.046||||||0.05|||||||t-test, 2 sided|||P=.046||||0.05
73869237|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.17|0.78|
73943333|NCT03017079|147419634|NON_INFERIORITY|a 0.05|Odds Ratio (OR)|0.05||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
73943334|NCT03017079|147419635|SUPERIORITY|||||||0.05|||||||Chi-squared, Corrected|||||||0.05
73943335|NCT03017079|147419637|NON_INFERIORITY|According to the rule of a=0.05, P\<0.05 means that the hypothesis was true|||||<|0.05|||||||Chi-squared, Corrected|||||||<0.05
73943336|NCT01345630|147419665|NON_INFERIORITY_OR_EQUIVALENCE|For the analysis of the primary endpoint conducted at Week 48, the alternative hypothesis was to test for non-inferiority of MVC+DRV/r to FTC/TDF+DRV/r with a non-inferiority margin of -10%.|Mean Difference (Final Values)|-9.54|||||TWO_SIDED|95.0|-14.83|-4.24||||||The difference in the percentages between the maraviroc and the emtricitabine/tenofovir treatment arms and the 2-sided 95% confidence interval for the difference was provided using the stratum-adjusted Mantel-Haenszel (MH) method over the two assays and the screening plasma HIV-1 RNA levels (\>=100,000 copies/mL or \<100,000 copies/mL). The sample size was chosen to yield a power of ≥90%. The 95% CIs and mean difference (final values) are presented as percentages above.||-4.24|-14.83|
73943337|NCT01345630|147419673|SUPERIORITY_OR_OTHER||Treatment difference|-0.075|STANDARD_ERROR_OF_MEAN|0.0303|||TWO_SIDED|95.0|-0.1343|-0.0157||||||The difference in proportions of patients with plasma HIV-1 RNA \<50 copies/mL at Week 48 between the \[MVC+DRV/r\] and the \[FTC/TDF+DRV/r\] treatment arms, with two-sided 95% confidence interval, is shown for those patients who were R5 by genotype (including all who were originally randomized to ESTA and were R5 by genotype upon retesting), via the maximum likelihood (ML) method.||-0.0157|-0.1343|
73975202|NCT02307682|147496009|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-9.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.2|-9.4|
73943338|NCT01345630|147419678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.975|TWO_SIDED|95.0|-24.4|23.6|||ANCOVA|||Results were from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||23.6|-24.4|0.9750
73975203|NCT02307682|147496009|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-10.0|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.0|-10.0|
73975204|NCT02307682|147496009|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-6.2|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||8.2|-6.2|
73975205|NCT02307682|147496009|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.5|9.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||9.3|-5.5|
73975206|NCT02307682|147496009|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-5.1|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||9.6|-5.1|
74031385|NCT04598165|147616288|SUPERIORITY||Risk Ratio (RR)|1.36||||0.217|TWO_SIDED|95.0|0.84|2.21||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.||2.21|0.84|0.217
73943339|NCT01345630|147419679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.5|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||-1.5|-3.1|<0.0001
73943340|NCT01345630|147419680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|127.7|||<|0.0001|TWO_SIDED|95.0|76.5|178.8|||ANCOVA|||Results were from ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||178.8|76.5|<0.0001
73943341|NCT01345630|147419681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|||<|0.0001|TWO_SIDED|95.0|1.1|3.1|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||3.1|1.1|<0.0001
73943342|NCT01345630|147419682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.07|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||-0.07|-0.15|<0.0001
73943343|NCT01345630|147419683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.861||||0.8379|TWO_SIDED|95.0|-658.181|809.903|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||809.903|-658.181|0.8379
73943344|NCT01345630|147419684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.3376|TWO_SIDED|95.0|-0.033|0.094|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.094|-0.033|0.3376
73943345|NCT01345630|147419685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014||||0.0043|TWO_SIDED|95.0|0.004|0.023|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.023|0.004|0.0043
73943346|NCT01345630|147419686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.2273|TWO_SIDED|95.0|-0.005|0.022|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.022|-0.005|0.2273
73975207|NCT02307682|147496009|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.0|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.9|-5.0|
73975208|NCT02307682|147496009|OTHER||Difference in proportions|3.2|||||TWO_SIDED|95.0|-3.9|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||10.3|-3.9|
73975209|NCT02307682|147496009|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-6.1|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.1|-6.1|
73975210|NCT02307682|147496009|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.1|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.9|-5.1|
73975211|NCT02307682|147496009|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-5.9|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.4|-5.9|
73975212|NCT02307682|147496009|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-8.5|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||5.8|-8.5|
73975213|NCT02307682|147496009|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-9.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.7|-9.7|
73975214|NCT02307682|147496009|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-7.9|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.5|-7.9|
73975215|NCT02307682|147496009|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-9.1|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.5|-9.1|
73975216|NCT02307682|147496009|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-2.9|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||11.2|-2.9|
73975217|NCT02307682|147496009|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-6.6|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||8.0|-6.6|
74031386|NCT04598165|147616289|SUPERIORITY||Risk Ratio (RR)|1.04||||0.064|TWO_SIDED|95.0|1.0|1.08||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in early initiation of breast feeding assuming 80% uptake in controls.||1.08|1.00|0.064
73869238|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.62|0.96||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||0.96|0.62|
73975218|NCT02307682|147496010|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-1.4|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.2|-1.4|
73975219|NCT02307682|147496010|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-0.5|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||4.0|-0.5|
73975220|NCT02307682|147496010|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-2.6|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.5|-2.6|
73975221|NCT02307682|147496010|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-1.7|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.9|-1.7|
74039448|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.0661|TWO_SIDED|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.02|-0.50|0.0661
73943347|NCT01345630|147419687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.4188|TWO_SIDED|95.0|-0.007|0.018|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.018|-0.007|0.4188
73943348|NCT01345630|147419688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.1722|TWO_SIDED|95.0|-5.17|0.94|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.94|-5.17|0.1722
73943349|NCT01345630|147419689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-126.78||||0.0071|TWO_SIDED|95.0|-218.34|-35.23|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||-35.23|-218.34|0.0071
73943350|NCT03938454|147419697|OTHER||Hodges-Lehmann|45.98||||0.0676|TWO_SIDED|95.0|23.5|65.36||P-value is from one-sided Wilcoxon Sign Rank Test with at least 25% percent reduction from Baseline (adjusted for 26 weeks) as outcome variable.|Wilcoxon Sign Rank Test|||||65.36|23.50|0.0676
73943351|NCT03938454|147419703|OTHER||Hodges-Lehmann|50.2||||0.0259|TWO_SIDED|95.0|27.94|67.36||P-value is from one-sided Wilcoxon Sign Rank Test with at least 25% reduction from Baseline (adjusted for 26 weeks) as outcome variable.|Wilcoxon Sign Rank Test|||||67.36|27.94|0.0259
73943352|NCT01142388|147419709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|TWO_SIDED||||||Log Rank|one-sided stratified log rank test, stratifying on: 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.||||||0.85
73943353|NCT01142388|147419710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|TWO_SIDED||||||Log Rank|one-sided stratified log rank test, stratifying on 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.||||||0.50
73943354|NCT01787097|147419719|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73943355|NCT03810534|147419724|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|3.24||0.62|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.62
73975222|NCT02307682|147496010|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-3.3|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-3.3|
73975223|NCT02307682|147496010|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-3.2|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.7|-3.2|
73975224|NCT02307682|147496010|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-3.0|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.4|-3.0|
73869239|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.87|1.31||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.31|0.87|
73975225|NCT02307682|147496010|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.4|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.1|-2.4|
73975226|NCT02307682|147496010|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.2|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.4|-2.2|
73975227|NCT02307682|147496010|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-0.3|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||5.3|-0.3|
73943356|NCT03810534|147419725|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|1.44||0.31|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.31
73943357|NCT03810534|147419726|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.33||0.93|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.93
73869240|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.91|||||TWO_SIDED|95.0|0.71|1.15||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.15|0.71|
73943358|NCT03810534|147419727|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.34||0.6|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.60
73943359|NCT03810534|147419728|SUPERIORITY||Mean Difference (Final Values)|2.24|STANDARD_ERROR_OF_MEAN|3.49||0.53|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.53
73943360|NCT03810534|147419729|SUPERIORITY||Mean Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|3.57||0.83|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.83
73943361|NCT03810534|147419730|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|2.05||0.75|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.75
73943362|NCT03810534|147419731|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|2.07||0.5|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.50
73943363|NCT03810534|147419732|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.5||0.48|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.48
73943364|NCT03810534|147419733|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.52||0.22|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.22
73943365|NCT03810534|147419734|SUPERIORITY||Mean ratio|0.96|STANDARD_ERROR_OF_MEAN|0.25||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||.88
73943366|NCT03810534|147419735|SUPERIORITY||Mean ratio|0.72|STANDARD_ERROR_OF_MEAN|0.18||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||.23
73943367|NCT02293395|147419739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.584|TWO_SIDED|95.0|0.8|1.5|||Log Rank|||||1.5|0.8|0.584
73943368|NCT02597907|147419740|OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
73943369|NCT00861614|147419750|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0127|TWO_SIDED|95.0|0.71|0.96|||Log Rank||Ipilimumab over placebo|||0.96|0.71|0.0127
73943370|NCT00861614|147419752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.61|0.82|||||Ipilimumab over placebo|||0.82|0.61|
73943371|NCT00861614|147419754|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.02|4.0|||||Ipilimumab over placebo|||4.00|0.02|
73943372|NCT00944658|147419772|SUPERIORITY|||||||0.139|||||||ANCOVA|||||||0.139
73943373|NCT00944658|147419773|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.58
73975228|NCT02307682|147496010|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.6|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.2|-2.6|
73943374|NCT00944658|147419774|SUPERIORITY|||||||0.108|||||||ANCOVA|Rank Ancova||||||0.108
73943375|NCT00297115|147419804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|58.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|41.0|75.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||75|41|<0.0001
73943376|NCT00297115|147419805|SUPERIORITY_OR_OTHER||Rate ratio|0.815|STANDARD_ERROR_OF_MEAN|0.057||0.0035|TWO_SIDED|95.0|0.71|0.935||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||0.935|0.710|0.0035
73943377|NCT00297115|147419806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|61.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|44.0|79.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||79|44|<0.0001
73943378|NCT00297115|147419807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213|STANDARD_ERROR_OF_MEAN|0.35||0.5028|TWO_SIDED|95.0|0.689|2.137||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 772 in the roflumilast group, n= 796 in the placebo group).|||2.137|0.689|0.5028
73943379|NCT00297115|147419808|SUPERIORITY_OR_OTHER||Mean Difference calculated as ratio|1.0593||||0.3627|TWO_SIDED|95.0|0.9356|1.1994||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method||||1.1994|0.9356|0.3627
73943380|NCT00297115|147419809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.104||0.0059|TWO_SIDED|95.0|0.082|0.489||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||0.489|0.082|0.0059
73943381|NCT02472652|147419822|OTHER||change in prolactin|30.0|||||TWO_SIDED|||||||||||||
73943382|NCT02713711|147419823|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.3262|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.3262
73943383|NCT02713711|147419823|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.01|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.01
74031387|NCT04598165|147616290|SUPERIORITY||Risk Ratio (RR)|0.99||||0.363|TWO_SIDED|95.0|0.98|1.01||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in exclusive breast feeding assuming 80% uptake in controls.||1.01|0.98|0.363
74031388|NCT04598165|147616291|SUPERIORITY||Risk Ratio (RR)|1.01||||0.093|TWO_SIDED|95.0|1.0|1.02||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.||1.02|1.00|0.093
74031389|NCT04598165|147616292|SUPERIORITY||Risk Ratio (RR)|1.03||||0.353|TWO_SIDED|95.0|0.97|1.09||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.||1.09|0.97|0.353
74031390|NCT04598165|147616293|SUPERIORITY||Risk Ratio (RR)|1.14||||0.751|TWO_SIDED|95.0|0.5|2.61||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.53 in provision of Kangaroo Mother Care assuming 25% in controls.||2.61|0.50|0.751
74031391|NCT04598165|147616294|SUPERIORITY||Risk Ratio (RR)|1.0||||0.431|TWO_SIDED|95.0|1.0|1.01||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.04 in number of danger signs correctly named assuming median of 3 in controls.||1.01|1.00|0.431
74039449|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.13||0.0009|TWO_SIDED|95.0|-0.7|-0.18|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.18|-0.70|0.0009
73869241|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.12||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.12|0.69|
73869242|NCT03828617|147282998|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.79|1.24||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.79|
73943384|NCT02713711|147419823|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.0646|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.0646
73869243|NCT00082407|147283015|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and biphasic insulin aspart is less than 0.4%.)|Mean Difference (Final Values)|-0.1||||0.2534||95.0|-0.28|0.08|||ANCOVA|||||0.08|-0.28|0.2534
73869244|NCT00082407|147283016|SUPERIORITY_OR_OTHER|||||||0.0779||95.0|||||Fisher Exact|||||||0.0779
73869245|NCT00082407|147283017|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
73943385|NCT02713711|147419823|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.|||||<|0.001|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||<0.001
73869246|NCT00082407|147283018|SUPERIORITY_OR_OTHER|||||||0.6456||95.0|||||ANCOVA|||||||0.6456
73943386|NCT02713711|147419823|SUPERIORITY|Two-way ANOVA (Bonferroni post-test) for intergroup analysis.|||||<|0.001|||||||ANOVA|||||||<0.001
73943387|NCT02713711|147419824|SUPERIORITY|paired-t test (intragroup analysis)||||||0.208|||||||t-test, 2 sided|||||||0.2080
73943388|NCT02713711|147419824|SUPERIORITY|paired-t test (intragroup analysis)||||||0.0136|||||||t-test, 2 sided|||||||0.0136
73943389|NCT02713711|147419824|SUPERIORITY|paired-t test (intragroup analysis)||||||0.2987|||||||t-test, 2 sided|||||||0.2987
73943390|NCT02713711|147419824|SUPERIORITY|paired-t test (intragroup analysis)||||||0.8347|||||||t-test, 2 sided|||||||0.8347
73943391|NCT02713711|147419824|SUPERIORITY|two-way ANOVA with Bonferroni post hoc test (intergroup analysis)||||||0.0001|||||||ANOVA|||||||0.0001
73943392|NCT00998400|147419828|SUPERIORITY|||||||0.03|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||0.030
73943393|NCT00998400|147419829|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
73943394|NCT00998400|147419830|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
73943395|NCT00998400|147419831|SUPERIORITY||||||>|0.05|||||||Kaplan-Meier Survival analysis|||||||>0.05
73943396|NCT00998400|147419832|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
73943397|NCT00998400|147419833|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
73943398|NCT00998400|147419834|SUPERIORITY|||||||0.013|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||0.013
73943399|NCT00998400|147419835|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
73975229|NCT02307682|147496010|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-1.8|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||4.6|-1.8|
74039450|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.16||0.0008|TWO_SIDED|95.0|-0.84|-0.22|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.22|-0.84|0.0008
73975230|NCT02307682|147496010|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-2.9|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.3|-2.9|
73869247|NCT00082407|147283020|SUPERIORITY_OR_OTHER|||||||0.7888||95.0|||||Fisher Exact|||||||0.7888
73869248|NCT00082407|147283021|SUPERIORITY_OR_OTHER|||||||0.3722||95.0|||||ANCOVA|||||||0.3722
73869249|NCT00118742|147283030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.9||||0.0012||95.0|14.8|35.0|||ANCOVA|||||35.0|14.8|0.0012
73943400|NCT00998400|147419836|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
73943401|NCT00998400|147419837|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
73943402|NCT00998400|147419838|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
73943403|NCT00998400|147419839|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
73943404|NCT03386032|147419850|SUPERIORITY||||||<|0.05|||||||ANCOVA|Model adjusted means.||Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.||||<0.05
73943405|NCT03386032|147419851|SUPERIORITY||||||<|0.05|||||||ANCOVA|Model adjusted means. Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left miss||"Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.~Significance level: 0.05 (2-sided)"||||<0.05
73943406|NCT01493687|147419869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73943407|NCT01493687|147419870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.13|||<|0.001|TWO_SIDED|95.0|-10.12|-6.13|||ANCOVA|||||-6.13|-10.12|<0.001
73943408|NCT01493687|147419871|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73943409|NCT05067439|147419872|OTHER||Ratio of Adjusted Geometric Means|288.81|||||TWO_SIDED|90.0|240.56|346.73||||||Omeprazole 10 mg was Reference and abrocitinib 200 mg + omeprazole 10 mg was Test. Natural log-transformed AUCinf was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||346.73|240.56|
73943410|NCT05067439|147419873|OTHER||Ratio of Adjusted Geometric Means|139.59|||||TWO_SIDED|90.0|121.98|159.74||||||Caffeine 100 mg was Reference and abrocitinib 200 mg + caffeine 100 mg was Test. Natural log-transformed AUCinfCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||159.74|121.98|
73943411|NCT05067439|147419874|OTHER||Ratio of Adjusted Geometric Means|110.1|||||TWO_SIDED|90.0|103.45|117.17||||||Efavirenz 50 mg was Reference and abrocitinib 200 mg + efavirenz 50 mg was Test. Natural log-transformed AUClastCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||117.17|103.45|
73943412|NCT02323646|147419889|SUPERIORITY|||||||0.0019|||||||Fisher Exact|||||||0.0019
73943413|NCT02323646|147419889|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
73943414|NCT02323646|147419890|SUPERIORITY|||||||0.0237|||||||Fisher Exact|||||||0.0237
73943415|NCT02323646|147419890|SUPERIORITY|||||||0.0272|||||||Fisher Exact|||||||0.0272
73943416|NCT02323646|147419891|SUPERIORITY|||||||0.0145|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.||||0.0145
73943417|NCT02323646|147419891|SUPERIORITY|||||||0.0662|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.||||0.0662
73943418|NCT02323646|147419891|SUPERIORITY|||||||0.0061|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.||||0.0061
73943419|NCT02323646|147419891|SUPERIORITY|||||||0.0296|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.||||0.0296
73975231|NCT02307682|147496010|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.3|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.6|-2.3|
73975232|NCT02307682|147496010|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-2.0|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.1|-2.0|
73975233|NCT02307682|147496010|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-1.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.7|-1.0|
74039451|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.0|-0.38|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.38|-1.00|<.0001
73943420|NCT02323646|147419892|SUPERIORITY|||||||0.2642|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.2642
73943421|NCT02323646|147419892|SUPERIORITY|||||||0.4383|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.4383
73943422|NCT02323646|147419892|SUPERIORITY|||||||0.5333|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5333
73943423|NCT02323646|147419892|SUPERIORITY|||||||0.8791|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8791
73943424|NCT02323646|147419892|SUPERIORITY|||||||0.3666|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up||||0.3666
73943425|NCT02323646|147419892|SUPERIORITY|||||||0.345|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up||||0.3450
73943426|NCT02323646|147419893|SUPERIORITY|||||||0.0473|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0473
73943427|NCT02323646|147419893|SUPERIORITY|||||||0.0191|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0191
73943428|NCT02323646|147419893|SUPERIORITY|||||||0.0749|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0749
73943429|NCT02323646|147419893|SUPERIORITY|||||||0.0233|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0233
73943430|NCT02323646|147419893|SUPERIORITY|||||||0.7569|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7569
73943431|NCT02323646|147419893|SUPERIORITY|||||||0.5399|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.5399
73943432|NCT02323646|147419894|SUPERIORITY|||||||0.1683|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1683
73943433|NCT02323646|147419894|SUPERIORITY|||||||0.256|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.2560
73943434|NCT02323646|147419894|SUPERIORITY|||||||0.4997|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.4997
73943435|NCT02323646|147419894|SUPERIORITY|||||||0.1334|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.1334
73943436|NCT02323646|147419894|SUPERIORITY|||||||0.0323|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.0323
74031392|NCT04598165|147616295|SUPERIORITY||Risk Ratio (RR)|1.03||||0.321|TWO_SIDED|95.0|0.98|1.08||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in appropriate care seeking assuming 1 clinic visit in the 6-weeks postpartum for controls.||1.08|0.98|0.321
74031393|NCT04598165|147616296|SUPERIORITY||Risk Ratio (RR)|1.01||||0.65|TWO_SIDED|95.0|0.98|1.04||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 0.76 in elevated depression symptoms assuming 19% in controls.||1.04|0.98|0.650
74031394|NCT04598165|147616297|SUPERIORITY||Coefficient|0.09||||0.071|TWO_SIDED|95.0|-0.007|0.18||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Linear generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.|||0.18|-0.007|0.071
74031395|NCT04598165|147616298|SUPERIORITY||Coefficient|0.02||||0.19|TWO_SIDED|95.0|-0.01|0.04||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Linear generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.|||0.04|-0.01|0.190
74031396|NCT00337467|147616327|SUPERIORITY_OR_OTHER||Percentage of Participants|21.3|||||TWO_SIDED|95.0|11.9|33.7|||exact binomial methods|Given the small sample size, the 95% confidence interval is made with exact binomial methods.||||33.7|11.9|
74031397|NCT00337467|147616328|SUPERIORITY_OR_OTHER||Percentage of Participants|34.4|||||TWO_SIDED|95.0|22.7|47.7|||exact binomial methods|Given the small sample size, the 95% confidence interval is made with exact binomial methods.||||47.7|22.7|
74031398|NCT00337467|147616333|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|61.0|STANDARD_ERROR_OF_MEAN|24.3|||TWO_SIDED|95.0|12.3|109.8|||normal approximation for 95% CI|||||109.8|12.3|
74031399|NCT00337467|147616334|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|53.0|STANDARD_ERROR_OF_MEAN|30.0|||TWO_SIDED|95.0|-7.1|113.7|||normal approximation for 95% CI|||||113.7|-7.1|
74031400|NCT00337467|147616335|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|63.0|STANDARD_ERROR_OF_MEAN|32.9|||TWO_SIDED|95.0|-4.0|129.1|||normal approximation for 95% CI|||||129.1|-4.0|
74031401|NCT00337467|147616337|SUPERIORITY_OR_OTHER||Mean Change|9.0|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|2.5|14.6|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Total Cholesterol at Week 48||14.6|2.5|
74031402|NCT00337467|147616337|SUPERIORITY_OR_OTHER||Mean Change|2.0|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-3.9|8.8|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting HDL Cholesterol at Week 48||8.8|-3.9|
74031403|NCT00337467|147616337|SUPERIORITY_OR_OTHER||Mean Change|12.0|STANDARD_ERROR_OF_MEAN|4.1|||TWO_SIDED|95.0|4.0|20.8|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 48||20.8|4.0|
74031404|NCT00337467|147616337|SUPERIORITY_OR_OTHER||Mean Change|20.0|STANDARD_ERROR_OF_MEAN|5.8|||TWO_SIDED|95.0|8.0|31.7|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting LDL Cholesterol at Week 48||31.7|8.0|
74031405|NCT00337467|147616337|SUPERIORITY_OR_OTHER||Mean Change|17.0|STANDARD_ERROR_OF_MEAN|8.6|||TWO_SIDED|95.0|-0.4|34.4|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Triglycerides at Week 48||34.4|-0.4|
74031406|NCT00337467|147616338|SUPERIORITY_OR_OTHER||Mean Change|14.0|STANDARD_ERROR_OF_MEAN|3.2||||95.0|6.9|20.1|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Total Cholesterol at Week 96||20.1|6.9|
74031407|NCT00337467|147616338|SUPERIORITY_OR_OTHER||Mean Change|2.0|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-6.0|10.2|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting HDL Cholesterol at Week 96||10.2|-6.0|
74031408|NCT00337467|147616338|SUPERIORITY_OR_OTHER||Mean Change|19.0|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|10.3|28.4|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 96||28.4|10.3|
73869250|NCT00118742|147283031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.6|||<|0.0001||95.0|15.7|35.6|||ANCOVA|||||35.6|15.7|<0.0001
73869251|NCT00118742|147283032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.7||||0.0053||95.0|13.7|43.7|||ANCOVA|||||43.7|13.7|0.0053
73975234|NCT02307682|147496010|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-1.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.4|-1.5|
73975235|NCT02307682|147496010|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|0.0|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.5|0.0|
73975236|NCT02307682|147496010|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.1|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.9|-2.1|
73869252|NCT00118742|147283033|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|21.1|||<|0.0001||95.0|12.5|29.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 6 months posttransplant||29.6|12.5|<0.0001
73975237|NCT02307682|147496010|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-0.7|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.3|-0.7|
73975238|NCT02307682|147496010|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-2.2|
73975239|NCT02307682|147496010|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-1.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.2|-1.4|
73975240|NCT02307682|147496010|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.2|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.9|-3.2|
73975241|NCT02307682|147496010|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.7|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||4.3|-2.7|
73975242|NCT02307682|147496010|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.3|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.0|-3.3|
73975243|NCT02307682|147496010|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.5|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-2.5|
73975244|NCT02307682|147496010|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.4|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.6|-2.4|
73975245|NCT02307682|147496010|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.5|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.3|-1.5|
73869253|NCT00118742|147283033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.2|||<|0.0001||95.0|9.9|26.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 12 months posttransplant||26.6|9.9|<0.0001
73975246|NCT02307682|147496010|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.6|-3.5|
73975247|NCT02307682|147496010|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.9|-2.9|
73869254|NCT00118742|147283033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.6||||0.0006||95.0|10.2|37.0|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 24 months posttransplant||37.0|10.2|0.0006
73869255|NCT01363908|147283055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0781|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.0781
73869256|NCT01363908|147283055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to \<12 year olds at 48 weeks||||0.5000
73869257|NCT01363908|147283055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2609|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.2609
73869258|NCT01363908|147283055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9219|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.9219
73943437|NCT02323646|147419894|SUPERIORITY|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3847
73943438|NCT02323646|147419895|SUPERIORITY|||||||0.6356|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.6356
73943439|NCT02323646|147419895|SUPERIORITY|||||||0.9539|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.9539
73943440|NCT02323646|147419895|SUPERIORITY|||||||0.5219|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5219
73943441|NCT02323646|147419895|SUPERIORITY|||||||0.2678|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.2678
73943442|NCT02323646|147419895|SUPERIORITY|||||||0.3086|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3086
73943443|NCT02323646|147419895|SUPERIORITY|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3847
73943444|NCT02323646|147419896|SUPERIORITY|||||||0.8393|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8393
73943445|NCT02323646|147419896|SUPERIORITY|||||||0.1361|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1361
73975248|NCT02307682|147496010|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.1|-2.4|
73943446|NCT02323646|147419896|SUPERIORITY|||||||0.0382|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0382
73943447|NCT02323646|147419896|SUPERIORITY|||||||0.6273|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.6273
73943448|NCT02323646|147419896|SUPERIORITY|||||||0.8237|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.8237
73943449|NCT02323646|147419896|SUPERIORITY|||||||0.137|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.1370
73975249|NCT02307682|147496010|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.3|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||6.7|-1.3|
73975250|NCT02307682|147496010|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-3.1|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.5|-3.1|
74031409|NCT00337467|147616338|SUPERIORITY_OR_OTHER||Mean Change|29.0|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|95.0|15.3|42.0|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting LDL Cholesterol at Week 96||42.0|15.3|
74031410|NCT00337467|147616338|SUPERIORITY_OR_OTHER||Mean Change|16.0|STANDARD_ERROR_OF_MEAN|12.5|||TWO_SIDED|95.0|-9.5|41.6|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Triglycerides at Week 96||41.6|-9.5|
73943450|NCT02323646|147419897|SUPERIORITY|||||||0.7949|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.7949
73943451|NCT02323646|147419897|SUPERIORITY|||||||0.1928|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1928
73943452|NCT02323646|147419897|SUPERIORITY|||||||1|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||1.0000
73943453|NCT02323646|147419897|SUPERIORITY|||||||0.392|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.3920
73943454|NCT02323646|147419897|SUPERIORITY|||||||0.541|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.5410
73943455|NCT02323646|147419897|SUPERIORITY|||||||0.4602|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.4602
73943456|NCT02323646|147419898|SUPERIORITY|||||||0.9536|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.9536
73943457|NCT02323646|147419898|SUPERIORITY|||||||0.1355|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1355
73943458|NCT02323646|147419898|SUPERIORITY|||||||0.9396|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.9396
73943459|NCT02323646|147419898|SUPERIORITY|||||||0.9102|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.9102
73943460|NCT02323646|147419898|SUPERIORITY|||||||0.6266|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.6266
73943461|NCT02323646|147419898|SUPERIORITY|||||||0.9302|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.9302
73943462|NCT02323646|147419899|SUPERIORITY|||||||0.817|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8170
73943463|NCT02323646|147419899|SUPERIORITY|||||||0.8177|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8177
73943464|NCT02323646|147419899|SUPERIORITY|||||||0.3167|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.3167
73943465|NCT02323646|147419899|SUPERIORITY|||||||0.5503|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5503
73943466|NCT02323646|147419899|SUPERIORITY|||||||0.6929|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.6929
73943467|NCT02323646|147419899|SUPERIORITY|||||||0.726|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7260
73943468|NCT02323646|147419900|SUPERIORITY|||||||0.3896|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.3896
73943469|NCT02323646|147419900|SUPERIORITY|||||||0.1358|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1358
73943470|NCT02323646|147419900|SUPERIORITY|||||||0.7903|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.7903
73943471|NCT02323646|147419900|SUPERIORITY|||||||0.8206|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8206
73869259|NCT01363908|147283057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6875|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.6875
73869260|NCT01363908|147283057|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to \<12 year olds at 48 weeks||||1.0000
73943472|NCT02323646|147419900|SUPERIORITY|||||||0.7891|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7891
73943473|NCT02323646|147419900|SUPERIORITY|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.4010
73943474|NCT02323646|147419901|SUPERIORITY|||||||0.0294|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0294
73943475|NCT02323646|147419901|SUPERIORITY|||||||0.1934|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1934
73943476|NCT02323646|147419901|SUPERIORITY|||||||0.0442|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0442
73943477|NCT02323646|147419901|SUPERIORITY|||||||0.8314|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8314
73975251|NCT02307682|147496010|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.9|-2.9|
73975252|NCT02307682|147496010|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.6|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.7|-2.6|
73975253|NCT02307682|147496010|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.7|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.3|-2.7|
73975254|NCT02307682|147496010|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.1|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.2|-3.1|
73975255|NCT02307682|147496010|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.1|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.0|-2.1|
73975256|NCT02307682|147496010|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-4.8|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.1|-4.8|
73975257|NCT02307682|147496010|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.9|-4.6|
73975258|NCT02307682|147496010|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-2.6|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.4|-2.6|
73975259|NCT02307682|147496010|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.4|-3.7|
73869261|NCT01363908|147283057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8181|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.8181
73869262|NCT01363908|147283057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5566|TWO_SIDED|||||P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank|||Analysis of 12 to \<18 year olds at 48 weeks||||0.5566
73943478|NCT02940574|147419938|OTHER|Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of 'treatment' (F(1,36)=2.00; p=.08 (one-sided))|||||<|0.08||||||Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of 'treatment' (F(1,36)=2.00; p=.08 (one-sided))|Mixed Models Analysis|(F(1,36)=2.00; p=.08 (one-sided))||||||<0.08
73943479|NCT03525548|147419976|SUPERIORITY||Least squares (LS) mean difference|10.0|||<|0.0001|TWO_SIDED|95.0|7.4|12.6|||Mixed-effects model for repeated measure|||||12.6|7.4|<0.0001
73943480|NCT03525548|147419977|SUPERIORITY||LS mean difference|-45.1|||<|0.0001|TWO_SIDED|95.0|-50.1|-40.1|||Mixed-effects model for repeated measure|||||-40.1|-50.1|<0.0001
73943481|NCT03525548|147419978|SUPERIORITY||LS mean difference|17.4|||<|0.0001|TWO_SIDED|95.0|11.8|23.0|||Mixed-effects model for repeated measure|||||23.0|11.8|<0.0001
73943482|NCT00643123|147419991|OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|2.3||0.45|TWO_SIDED||||||t-test, 2 sided|||||||.45
73869263|NCT01363908|147283059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0475|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.0475
73943483|NCT02623855|147419995|SUPERIORITY|Our hypothesis was that park prescriptions with group visits would have a superior result than park prescriptions alone.||||||0.6099|||||||t-test, 2 sided|||The study is powered for our primary outcome, caregiver stress as measured by the 10-item perceived stress s score (PSS10). Normative data from population samples show a mean PSS10 score of 13.2 points with a standard deviation of 6.35 points and a within-subject correlation coefficient of 0.77 over 2 weeks.We powered the study to detect a three point difference in the change of the PSS10. This effect size is consistent with other estimates of a clinically significant change.||||0.6099
73943484|NCT02623855|147419997|SUPERIORITY|||||||0.0085|||||||t-test, 2 sided|||||||0.0085
73943485|NCT02623855|147419999|SUPERIORITY|||||||0.1749|||||||t-test, 2 sided|||||||0.1749
73943486|NCT01591382|147420003|SUPERIORITY_OR_OTHER|||||||0.0241||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.0241
73975260|NCT02307682|147496010|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.4|-3.7|
73975261|NCT02307682|147496010|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-4.1|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.2|-4.1|
73975262|NCT02307682|147496010|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-2.2|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.5|-2.2|
73975263|NCT02307682|147496010|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.0|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.1|-3.0|
73975264|NCT02307682|147496010|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.9|-2.9|
73975265|NCT02307682|147496010|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-3.6|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.6|-3.6|
73975266|NCT02307682|147496011|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.7|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.2|-3.7|
74031411|NCT04083222|147616341|SUPERIORITY||||||<|0.001||||||P-value was analyzed using Analysis of Variance (ANOVA) with treatment and screening angiotensin-converting enzyme inhibitor/ angiotensin receptor blockers (ACEi/ARB) dose status stratification factor.|ANOVA|||||||< 0.001
74031412|NCT04083222|147616342|SUPERIORITY|||||||0.399||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.399
73869264|NCT01363908|147283059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.||Analysis of 6 to \<12 year olds at 48 weeks||||0.4410
73975267|NCT02307682|147496011|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.6|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.4|-2.6|
73975268|NCT02307682|147496011|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-3.3|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.3|-3.3|
74031413|NCT04083222|147616342|SUPERIORITY|||||||0.338||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||0.338
74031414|NCT04083222|147616342|SUPERIORITY|||||||0.207||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||0.207
74031415|NCT04083222|147616342|SUPERIORITY|||||||0.927||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||0.927
74031416|NCT04083222|147616342|SUPERIORITY|||||||0.146||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||0.146
73869265|NCT01363908|147283059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0417|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.0417
73943487|NCT01591382|147420004|SUPERIORITY_OR_OTHER|||||||0.4102||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.4102
73943488|NCT01591382|147420005|SUPERIORITY_OR_OTHER|||||||0.1085||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.1085
73943489|NCT01591382|147420006|SUPERIORITY_OR_OTHER|||||||0.748|||||||Wilcoxon (Mann-Whitney)|||||||0.7480
73943490|NCT02277990|147420012|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0406|TWO_SIDED|95.12|0.36|0.98||The 0.05 critical value for assessing the primary endpoint was adjusted to 0.0488, to account for a planned interim analysis.|Regression, Cox|The Cox regression was stratified according to device type (pacemaker or CRT-P vs. ICD or CRT-D).||||0.98|0.36|0.0406
73943491|NCT02277990|147420013|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0248|TWO_SIDED|95.12|0.47|0.96|||Regression, Cox|||||0.96|0.47|0.0248
73943492|NCT02277990|147420014|NON_INFERIORITY|The non-inferiority test was performed on the as-treated cohort, per the statistical analysis plan. The non-inferiority margin for the hazard ratio was 1.33 (i.e., the hazard ratio for complications in the envelope group vs. the control group must be significantly lower than 1.33).|Hazard Ratio (HR)|0.93|||<|0.01|TWO_SIDED|95.12|0.77|1.12|||Regression, Cox|||||1.12|0.77|<0.01
73943493|NCT02277990|147420015|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0402|TWO_SIDED|95.12|0.4|0.98|||Regression, Cox|||||0.98|0.40|0.0402
73943494|NCT03138733|147420025|NON_INFERIORITY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two sided 95% CI for the difference in response rates in the mITT population was greater than -15%, the non-inferiority of ceftobiprole to daptomycin therapy was to be concluded.|Adjusted proportion difference|2.0|||||TWO_SIDED|95.0|-7.1|11.1||||||The observed difference in percentage of responders at PTE (ceftobiprole group minus the daptomycin group) were determined and a two-sided 95% confidence interval (CI) for the observed difference was computed, with adjustment for actual stratum (dialysis status and prior antibacterial treatment use). Cochran-Mantel-Haenszel (CMH) weights were used for the stratum weight in the calculation of the CI||11.1|-7.1|
73943495|NCT03138733|147420026|OTHER||Adjusted proportion difference|0.6|||||TWO_SIDED|95.0|-8.3|9.5|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||9.5|-8.3|
73943496|NCT03138733|147420027|OTHER||Adjusted proportion difference|5.1|||||TWO_SIDED|95.0|-2.9|13.0|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||13|-2.9|
73943497|NCT03138733|147420028|OTHER||Adjusted proportion difference|-0.5|||||TWO_SIDED|95.0|-6.2|5.2|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||5.2|-6.2|
73943498|NCT03138733|147420029|OTHER||Adjusted proportion difference|0.1|||||TWO_SIDED|95.0|-4.6|4.8|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||4.8|-4.6|
73943499|NCT04252742|147420048|SUPERIORITY||LSM difference|-7.95|||<|0.001|TWO_SIDED|95.0|-11.45|-4.46||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-4.46|-11.45|< 0.001
73943500|NCT04252742|147420049|SUPERIORITY||LSM difference|-7.36|||<|0.001|TWO_SIDED|95.0|-10.8|-3.92||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-3.92|-10.80|< 0.001
73943501|NCT04252742|147420050|SUPERIORITY||LSM difference|-7.1|||<|0.001|TWO_SIDED|95.0|-10.34|-3.87||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.87|-10.34|< 0.001
73943502|NCT04252742|147420051|SUPERIORITY||LSM difference|-7.05|||<|0.001|TWO_SIDED|95.0|-10.76|-3.34||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.34|-10.76|< 0.001
73943503|NCT04252742|147420052|SUPERIORITY||LSM difference|-6.82|||<|0.001|TWO_SIDED|95.0|-10.37|-3.27||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.27|-10.37|< 0.001
73975269|NCT02307682|147496011|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-3.0|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.9|-3.0|
73943504|NCT04252742|147420053|SUPERIORITY||LSM difference|-1.07||||0.013|TWO_SIDED|95.0|-1.92|-0.22||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-0.22|-1.92|0.013
73943505|NCT04252742|147420054|SUPERIORITY||LSM difference|-0.48||||0.011|TWO_SIDED|95.0|-0.85|-0.11||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-0.11|-0.85|0.011
74031417|NCT04083222|147616342|SUPERIORITY|||||||0.055||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||0.055
73943506|NCT00394355|147420058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.261|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way analysis of variance (ANOVA) model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.261
73943507|NCT00394355|147420058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.644|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.644
73943508|NCT00394355|147420059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.359
73869266|NCT01363908|147283059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0409|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.0409
73869267|NCT01363908|147283060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9901|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.9901
73869268|NCT01363908|147283060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3039|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 48 weeks||||0.3039
73943509|NCT00394355|147420059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.390
73943510|NCT00394355|147420060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.169
73943511|NCT00394355|147420060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.526|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.526
73943512|NCT00394355|147420061|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.||||<0.001
73943513|NCT00394355|147420061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.||||0.023
73943514|NCT02618616|147420062|OTHER||least square difference|8.7||||0.8495|ONE_SIDED|90.0|8.4|||The 1-sided p-value tests if the ZPL-389 Least square (LS) mean is \< the placebo LS mean.|ANCOVA|||ANCOVA of PASI at Week 12|||8.4|0.8495
73943515|NCT02618616|147420063|OTHER||Odds Ratio (OR)|0.562||||0.9058|TWO_SIDED|90.0|0.27|1.16|||Regression, Logistic|||Logistic Regression PASI-50||1.16|0.27|0.9058
73943516|NCT02618616|147420063|OTHER||Odds Ratio (OR)|0.946||||0.5422|TWO_SIDED|90.0|0.4|2.25|||Regression, Logistic|||Logistic Regression PASI-75||2.25|0.4|0.5422
73943517|NCT01349920|147420082|SUPERIORITY_OR_OTHER|||||||0.071|||||||Multiple Linear Regression|||Week 6||||0.071
73975270|NCT02307682|147496011|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-4.6|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-4.6|
73943518|NCT01349920|147420082|SUPERIORITY_OR_OTHER|||||||0.381|||||||Multiple Linear Regression|||Week 22||||0.381
73943519|NCT05361655|147420100|OTHER||Hazard Ratio (HR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.65|0.87|||Cox proportional hazard model|||||0.87|0.65|<0.0001
73869269|NCT01363908|147283060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0044|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.0044
73975271|NCT02307682|147496011|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.6|-3.5|
74031418|NCT04083222|147616342|SUPERIORITY|||||||0.095||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||0.095
73869270|NCT01363908|147283060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0395|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.0395
73869271|NCT00536471|147283062|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||Repeated Measures Analysis for Group A change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit||||||0.051
73943520|NCT05361655|147420101|OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.62|0.76|||Cox proportional hazards model|||||0.76|0.62|<0.0001
73943521|NCT05361655|147420103|OTHER||||||<|0.0001|||||||score test|||||||<0.0001
73943522|NCT05361655|147420106|OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.6|0.72|||Cox proportional hazard model|||||0.72|0.60|<0.0001
73943523|NCT05361655|147420107|OTHER||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.51|0.62|||Cox proportional hazard model|||||0.62|0.51|<0.0001
73943524|NCT05361655|147420108|OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86|||Cox proportional hazard model|||||0.86|0.69|<0.0001
73943525|NCT05361655|147420109|OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.7|||Cox proportional hazards model|||||0.70|0.54|<0.0001
73943526|NCT00949715|147420121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.2352|TWO_SIDED|95.0|-2.7|10.8|||t-test, 2 sided|||HO: Pacing at selective RV sites (mid-septum or apex) has no different impact on the change in LVEF after 24 months follow-up. With 12% SD and 80 subjects in groups will have 90% power to detect an absolute difference in LVEF of 6.2% at 24 months follow-up at an alpha level of 0.05.||10.8|-2.7|0.2352
73943527|NCT00949715|147420122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.7405|TWO_SIDED|95.0|-7.6|5.5|||t-test, 2 sided|||Ho: Packing at selective RV sites (mid-Septum or apex) has no different impact on LVEF change from 2 weeks to 24 months.||5.5|-7.6|0.7405
73943528|NCT00949715|147420123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.3||||0.1051|TWO_SIDED|95.0|-25.1|2.4|||t-test, 2 sided|||Ho: Pacing at selective sites (RVS or RVA) has no different impact on LV end systolic volume||2.4|-25.1|0.1051
73975272|NCT02307682|147496011|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.2|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.9|-4.2|
74031419|NCT04083222|147616342|SUPERIORITY|||||||0.046||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||0.046
74031420|NCT04083222|147616342|SUPERIORITY|||||||0.246||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 57||||0.246
74031421|NCT04083222|147616342|SUPERIORITY|||||||0.17||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||0.170
74031422|NCT04083222|147616342|SUPERIORITY|||||||0.527||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||0.527
74031423|NCT04083222|147616342|SUPERIORITY|||||||0.167||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||0.167
74031424|NCT04083222|147616342|SUPERIORITY|||||||0.266||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.266
74031425|NCT04083222|147616342|SUPERIORITY|||||||0.078||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.078
74031426|NCT04083222|147616343|SUPERIORITY|||||||0.661||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.661
74031427|NCT04083222|147616343|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||<0.001
74031428|NCT04083222|147616343|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||<0.001
74031429|NCT04083222|147616343|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||<0.001
74031430|NCT04083222|147616343|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||<0.001
74031431|NCT04083222|147616343|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||<0.001
74031432|NCT04083222|147616343|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||<0.001
74031433|NCT04083222|147616343|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||<0.001
74031434|NCT04083222|147616343|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 57||||<0.001
74031435|NCT04083222|147616343|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||<0.001
74031436|NCT04083222|147616343|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||<0.001
74031437|NCT04083222|147616343|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||<0.001
74031438|NCT04083222|147616343|SUPERIORITY|||||||0.106||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.106
74031439|NCT04083222|147616343|SUPERIORITY|||||||0.318||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.318
74031440|NCT04083222|147616344|SUPERIORITY|||||||0.609||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.609
74031441|NCT04083222|147616344|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||<0.001
74031442|NCT04083222|147616344|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||<0.001
74031443|NCT04083222|147616344|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||<0.001
74031444|NCT04083222|147616344|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||<0.001
74031445|NCT04083222|147616344|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||<0.001
74031446|NCT04083222|147616344|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||<0.001
74031447|NCT04083222|147616344|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||<0.001
74031448|NCT04083222|147616344|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||<0.001
74031449|NCT04083222|147616344|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||<0.001
74031450|NCT04083222|147616344|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||<0.001
74031451|NCT04083222|147616344|SUPERIORITY|||||||0.112||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.112
74031452|NCT04083222|147616344|SUPERIORITY|||||||0.371||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.371
74031453|NCT03103750|147616346|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|||The primary hypothesis of calcitriol-related differences in amphetamine-induced dopamine release was determined by significance of the main effect of medication (calcitriol vs. placebo) on %change in BPND (i.e., post-Amp relative to pre-Amp scans) at a threshold of p\<0.05.||||0.016
74031454|NCT03103750|147616348|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
74031455|NCT01128972|147616349|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.66|||<|0.0001|TWO_SIDED|95.0|7.09|16.24||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||16.24|7.09|<0.0001
73869272|NCT00536471|147283062|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Repeated Measures Analysis for Group B change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit||||||<0.001
73943529|NCT00949715|147420124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.9||||0.9835||95.0||||Adjusting for age and gender|Wilcoxon (Mann-Whitney)|Rank Sum||Ho: The AT/AF burden in the RVS group is the same as the RVA group.||||0.9835
73943530|NCT00605202|147420134|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value of the change in the plasma potassium (baseline to 2 weeks) between arms|t-test, 2 sided|||Statistical analysis applies to the change in the plasma potassium (baseline to 2 weeks) between arms||||0.007
73943531|NCT05050578|147420135|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, sequence) and random (subject) effects. Difference = LID18869 minus AOHG. Sign is retained with the rounded value.|||0.00||
73943532|NCT03928028|147420140|SUPERIORITY|||||||0.507||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.507
73943533|NCT03928028|147420140|SUPERIORITY|||||||0.017||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.017
73943534|NCT03928028|147420140|SUPERIORITY|||||||0.139||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.139
73943535|NCT03928028|147420141|SUPERIORITY|||||||0.389|||||||generalized estimating equation|||This analysis compare mothers in FBT to mothers in FBT+CRTp||||.389
73943536|NCT03928028|147420141|SUPERIORITY|||||||0.447||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.447
73943537|NCT03928028|147420141|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||<.001
73943538|NCT03928028|147420142|SUPERIORITY|||||||0.778||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.778
73975273|NCT02307682|147496011|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-5.0|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.0|-5.0|
73975274|NCT02307682|147496011|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-4.1|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.4|-4.1|
73975275|NCT02307682|147496011|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.3|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.7|-2.3|
73975276|NCT02307682|147496011|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.1|-3.9|
73975277|NCT02307682|147496011|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-1.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.2|-1.8|
73975278|NCT02307682|147496011|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-3.5|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.7|-3.5|
73943539|NCT03928028|147420142|SUPERIORITY|||||||0.297||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.297
73943540|NCT03928028|147420142|SUPERIORITY|||||||0.062||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.062
73943541|NCT03928028|147420143|SUPERIORITY|||||||0.069||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.069
73943542|NCT03928028|147420143|SUPERIORITY|||||||0.323||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.323
73943543|NCT03928028|147420143|SUPERIORITY|||||||0.225|||||||generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.225
73975279|NCT02307682|147496011|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.6|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.4|-3.6|
73975280|NCT02307682|147496011|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.2|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.6|-3.2|
73975281|NCT02307682|147496011|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.2|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.5|-3.2|
73975282|NCT02307682|147496011|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.6|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||5.3|-2.6|
73975283|NCT02307682|147496011|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-2.1|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||5.9|-2.1|
73975284|NCT02307682|147496011|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.3|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.9|-4.3|
73975285|NCT02307682|147496011|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-3.6|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.8|-3.6|
73975286|NCT02307682|147496011|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.8|-3.7|
73975287|NCT02307682|147496011|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-3.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.7|-3.7|
74031456|NCT01128972|147616349|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|26.6|||<|0.0001|TWO_SIDED|95.0|22.02|31.18||No adjustments made for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||31.18|22.02|<0.0001
73975288|NCT02307682|147496011|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-2.2|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-2.2|
73975289|NCT02307682|147496011|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.9|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.3|-2.9|
73975290|NCT02307682|147496011|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.5|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-3.5|
73975291|NCT02307682|147496011|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-1.6|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||7.3|-1.6|
74039452|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.15||0.0274|TWO_SIDED|95.0|-0.61|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.04|-0.61|0.0274
73975292|NCT02307682|147496011|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.3|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.2|-2.3|
73975293|NCT02307682|147496011|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-2.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.7|-2.2|
73975294|NCT02307682|147496011|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-4.8|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.8|-4.8|
73975295|NCT02307682|147496011|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.8|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.9|-3.8|
73975296|NCT02307682|147496011|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-3.1|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.7|-3.1|
73975297|NCT02307682|147496011|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||6.4|-2.8|
73975298|NCT02307682|147496011|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-3.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.2|-3.4|
73975299|NCT02307682|147496011|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-2.8|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.6|-2.8|
73975300|NCT02307682|147496011|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-6.6|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.5|-6.6|
73975301|NCT02307682|147496011|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.1|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||3.8|-6.1|
73975302|NCT02307682|147496011|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-5.6|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||3.1|-5.6|
73975303|NCT02307682|147496011|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-2.9|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.9|-2.9|
73975304|NCT02307682|147496011|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.8|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.1|-5.8|
73975305|NCT02307682|147496011|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-3.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.5|-3.2|
73975306|NCT02307682|147496011|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.2|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.0|-4.2|
73975307|NCT02307682|147496011|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||6.7|-3.2|
73975308|NCT02307682|147496011|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.8|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.2|-5.8|
73975309|NCT02307682|147496011|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-5.2|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.6|-5.2|
73975310|NCT02307682|147496011|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-5.5|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.1|-5.5|
73975311|NCT02307682|147496011|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-5.3|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.4|-5.3|
73975312|NCT02307682|147496011|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.4|-5.7|
73975313|NCT02307682|147496011|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.4|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.3|-3.4|
73975314|NCT02307682|147496012|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.4|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.5|-2.4|
73975315|NCT02307682|147496012|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-1.8|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.8|-1.8|
74031457|NCT01128972|147616349|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.17|||<|0.0001|TWO_SIDED|95.0|32.59|41.74||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||41.74|32.59|<0.0001
73975316|NCT02307682|147496012|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.1|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.8|-4.1|
73869273|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.013
73975317|NCT02307682|147496012|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-1.7|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.8|-1.7|
74031458|NCT01128972|147616350|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.11||||0.0083|TWO_SIDED|95.0|1.07|7.15||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||7.15|1.07|0.0083
73975318|NCT02307682|147496012|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.3|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||6.5|-2.3|
73975319|NCT02307682|147496012|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-0.9|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||7.9|-0.9|
73975320|NCT02307682|147496012|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.4|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.0|-5.4|
73975321|NCT02307682|147496012|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.2|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.2|-6.2|
73869274|NCT00536471|147283063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
73869275|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.026
73943544|NCT03928028|147420144|SUPERIORITY|||||||0.196||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.196
73943545|NCT03928028|147420144|SUPERIORITY|||||||0.812||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.812
73943546|NCT03928028|147420144|SUPERIORITY|||||||0.499||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.499
73943547|NCT03928028|147420145|SUPERIORITY|||||||0.446||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.446
73943548|NCT03928028|147420145|SUPERIORITY|||||||0.647|||||||generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.647
73943549|NCT03928028|147420145|SUPERIORITY|||||||0.765||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.765
73943550|NCT03928028|147420146|SUPERIORITY|||||||0.425||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.425
73943551|NCT03928028|147420146|SUPERIORITY|||||||0.63|||||||generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.630
73943552|NCT03928028|147420146|SUPERIORITY|||||||0.854||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.854
73943553|NCT04525547|147420149|OTHER|||||||0.817|||||||t-test, 2 sided|||||||0.8170
73943554|NCT04525547|147420150|OTHER|||||||0.6533|||||||t-test, 2 sided|||||||0.6533
73943555|NCT04425902|147420160|OTHER||Ratio of geometric least square mean|1.11|||||TWO_SIDED|90.0|0.94|1.32|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.32|0.94|
73943556|NCT04425902|147420161|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.95|1.32|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.32|0.95|
73943557|NCT04425902|147420162|OTHER||Ratio of geometric least square mean|0.95|||||TWO_SIDED|90.0|0.83|1.08|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.08|0.83|
73943558|NCT04425902|147420165|OTHER||Ratio of geometric least square mean|1.23|||||TWO_SIDED|90.0|0.71|2.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||2.14|0.71|
73943559|NCT04425902|147420166|OTHER||Ratio of geometric least square mean|1.23|||||TWO_SIDED|90.0|0.71|2.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||2.14|0.71|
73943560|NCT04425902|147420167|OTHER||Ratio of geometric least square mean|1.11|||||TWO_SIDED|90.0|0.72|1.69|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.69|0.72|
73943561|NCT04425902|147420170|OTHER||Ratio of geometric least square mean|1.08|||||TWO_SIDED|90.0|0.97|1.2|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.20|0.97|
73943562|NCT04425902|147420171|OTHER||Ratio of geometric least square mean|1.09|||||TWO_SIDED|90.0|0.98|1.21|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.21|0.98|
73943563|NCT04425902|147420172|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.92|1.17|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.17|0.92|
73943564|NCT04425902|147420175|OTHER||Ratio of geometric least square mean|1.02|||||TWO_SIDED|90.0|0.88|1.18|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.18|0.88|
73943565|NCT04425902|147420176|OTHER||Ratio of geometric least square mean|1.03|||||TWO_SIDED|90.0|0.89|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.89|
73943566|NCT04425902|147420177|OTHER||Ratio of geometric least square mean|1.05|||||TWO_SIDED|90.0|0.93|1.18|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.18|0.93|
73943567|NCT04425902|147420180|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.72|1.75|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.75|0.72|
73943568|NCT04425902|147420181|OTHER||Ratio of geometric least square mean|0.97|||||TWO_SIDED|90.0|0.54|1.73|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.73|0.54|
73943569|NCT04425902|147420182|OTHER||Ratio of geometric least square mean|1.14|||||TWO_SIDED|90.0|0.73|1.78|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.78|0.73|
73943570|NCT04425902|147420185|OTHER||Ratio of geometric least square mean|0.94|||||TWO_SIDED|90.0|0.8|1.11|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.11|0.80|
73943571|NCT04425902|147420186|OTHER||Ratio of geometric least square mean|0.93|||||TWO_SIDED|90.0|0.79|1.1|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.10|0.79|
73869276|NCT00536471|147283063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
73869277|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.202
73869278|NCT00536471|147283063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
73975322|NCT02307682|147496012|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-5.4|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-5.4|
73975323|NCT02307682|147496012|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.9|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.4|-2.9|
73975324|NCT02307682|147496012|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.2|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.9|-5.2|
73975325|NCT02307682|147496012|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-1.4|8.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||8.8|-1.4|
73975326|NCT02307682|147496012|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-6.8|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-6.8|
73975327|NCT02307682|147496012|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.7|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.8|-4.7|
73975328|NCT02307682|147496012|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.0|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.4|-5.0|
73975329|NCT02307682|147496012|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-6.1|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.0|-6.1|
73975330|NCT02307682|147496012|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.8|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||7.7|-1.8|
73975331|NCT02307682|147496012|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.7|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.8|-2.7|
73975332|NCT02307682|147496012|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-5.9|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.0|-5.9|
73975333|NCT02307682|147496012|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-4.7|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.9|-4.7|
73869279|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.027
73975334|NCT02307682|147496012|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.5|-5.7|
73975335|NCT02307682|147496012|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.5|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.3|-6.5|
73869280|NCT00536471|147283063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
73869281|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.076||95.0||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.076
73943572|NCT04425902|147420187|OTHER||Ratio of geometric least square mean|0.9|||||TWO_SIDED|90.0|0.73|1.12|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.12|0.73|
73943573|NCT04425902|147420190|OTHER||Ratio of geometric least square mean|1.07|||||TWO_SIDED|90.0|0.94|1.22|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.22|0.94|
73943574|NCT04425902|147420191|OTHER||Ratio of geometric least square mean|1.05|||||TWO_SIDED|90.0|0.92|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.92|
73943575|NCT04425902|147420192|OTHER||Ratio of geometric least square mean|1.25|||||TWO_SIDED|90.0|0.96|1.63|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.63|0.96|
73943576|NCT04425902|147420195|OTHER||Ratio of geometric least square mean|0.73|||||TWO_SIDED|90.0|0.52|1.03|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.03|0.52|
73943577|NCT04425902|147420196|OTHER||Ratio of geometric least square mean|0.61|||||TWO_SIDED|90.0|0.45|0.82|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||0.82|0.45|
73943578|NCT04425902|147420197|OTHER||Ratio of geometric least square mean|0.78|||||TWO_SIDED|90.0|0.54|1.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.14|0.54|
73943579|NCT04425902|147420303|OTHER||Ratio of geometric least square mean|0.92|||||TWO_SIDED|90.0|0.49|1.71|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.71|0.49|
73943580|NCT04425902|147420304|OTHER||Ratio of geometric least square mean|0.93|||||TWO_SIDED|90.0|0.74|1.16|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.16|0.74|
73943581|NCT04425902|147420305|OTHER||Ratio of geometric least square mean|0.86|||||TWO_SIDED|90.0|0.43|1.72|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.72|0.43|
73943582|NCT04425902|147420308|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.75|1.29|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.29|0.75|
73943583|NCT04425902|147420309|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.75|1.29|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.29|0.75|
73943584|NCT04425902|147420310|OTHER||Ratio of geometric least square mean|0.94|||||TWO_SIDED|90.0|0.73|1.22|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.22|0.73|
73943585|NCT04425902|147420313|OTHER||Ratio of geometric least square mean|1.1|||||TWO_SIDED|90.0|0.93|1.3|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.30|0.93|
73943586|NCT04425902|147420314|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.83|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.83|
73975336|NCT02307682|147496012|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.7|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.9|-2.7|
73975337|NCT02307682|147496012|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.3|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.4|-4.3|
73975338|NCT02307682|147496012|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.6|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.3|-4.6|
73943587|NCT04425902|147420315|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.88|1.44|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.44|0.88|
73943588|NCT04425902|147420318|OTHER||Ratio of geometric least square mean|0.9|||||TWO_SIDED|90.0|0.75|1.09|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.09|0.75|
73943589|NCT04425902|147420319|OTHER||Ratio of geometric least square mean|0.91|||||TWO_SIDED|90.0|0.76|1.09|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.09|0.76|
73943590|NCT04425902|147420320|OTHER||Ratio of geometric least square mean|0.85|||||TWO_SIDED|90.0|0.65|1.1|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.10|0.65|
73943591|NCT01544998|147420346|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||0.26
73943592|NCT01544998|147420347|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||0.90
73975339|NCT02307682|147496012|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-3.9|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.6|-3.9|
73869282|NCT00536471|147283063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
73869283|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.149
73869284|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.062
73943593|NCT01544998|147420348|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||0.003
73975340|NCT02307682|147496012|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.0|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.1|-4.0|
73975341|NCT02307682|147496012|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-3.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.2|-3.8|
73943594|NCT01544998|147420349|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||0.14
73943595|NCT01544998|147420350|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||<0.001
73943596|NCT01544998|147420351|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||<0.001
73869285|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.629||95.0||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.629
73869286|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.194
73943597|NCT00855062|147420368|SUPERIORITY_OR_OTHER||Slope|-0.026|STANDARD_ERROR_OF_MEAN|0.248||0.37|TWO_SIDED|95.0|-0.512|0.46||The p-value was not adjusted for multiple comparisons.|Regression, Linear|||"The null hypothesis was that the 24-week changes of U NP Sum between the minocycline and placebo groups are the same.~The sample size calculation showed that 100 (50 participants in each group) were required to detect the clinically meaningful difference of 0.5 with 85% power, 0.05 Type I error, two-sample and two-sided test."||0.460|-0.512|0.370
73943598|NCT00855062|147420370|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.053||||0.613|TWO_SIDED|95.0|0.043|0.062||The p-value is not adjusted for multiple comparisons.|Fisher Exact|||"The null hypothesis is that the percentage of participants feeling better in the minocycline group after 24 week treatment is the same as the one in the placebo group."||0.062|0.043|0.613
73943599|NCT00855062|147420371|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.||||0.661
73943600|NCT00855062|147420372|SUPERIORITY_OR_OTHER|||||||0.941||95.0||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the 48-week survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.||||0.941
73975342|NCT02307682|147496012|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-4.5|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.6|-4.5|
73975343|NCT02307682|147496012|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-3.8|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.8|-3.8|
73975344|NCT02307682|147496012|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-2.9|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.3|-2.9|
73869287|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.525||95.0||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.525
73943601|NCT00855062|147420373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.11|STANDARD_ERROR_OF_MEAN|17.63||0.647|TWO_SIDED|95.0|-27.23|43.45||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 24-week change of CD4 cell counts in the minocycline group is the same as the one in the placebo group.||43.45|-27.23|0.647
73943602|NCT00855062|147420374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.77|STANDARD_ERROR_OF_MEAN|32.51||0.813|TWO_SIDED|95.0|-59.07|74.6||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 48-week change in CD4 cell counts in the minocycline group is the same as the one in the placebo group.||74.60|-59.07|0.813
73869288|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.595
73869289|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.736
73869290|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.368
73869291|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.660
73869292|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.334
73869293|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.568
73869294|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.216
73943603|NCT00855062|147420375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|STANDARD_ERROR_OF_MEAN|0.82||0.764||95.0|0.26|6.34||The p-value is not adjusted for multiple comparisons.|Regression, Logistic|"The model was not adjusted for any covariate (due to small number of being better in both groups."||"The null hypothesis is that the percentage of being better at week 24 compared to baseline in the minocycline group is the same as the one in the placebo group."||6.34|0.26|0.764
73943604|NCT00855062|147420376|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||The p-value is not adjusted for multiple comparisons.|Kruskal-Wallis|The chi-square score was 0.024 and the degree of freedom was 1.||The null hypothesis is that the median log10-transformed HIV RNA viral loads in the minocycline group is the same as the one in the placebo group.||||0.766
73943605|NCT00855062|147420377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|1.79||0.915|TWO_SIDED|95.0|-3.4|3.78||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CES-D and MSK scores.||The null hypothesis is that the mean 24-week change of CES-D score in the minocycline group is the same as the one in the placebo group.||3.78|-3.40|0.915
73943606|NCT02110901|147420387|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.254|TWO_SIDED|95.0|0.61|1.14|||Log Rank|||||1.14|0.61|0.254
73943607|NCT02110901|147420388|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.048|TWO_SIDED|95.0|0.43|1.0|||Log Rank|||||1.00|0.43|0.048
73975345|NCT02307682|147496012|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-2.8|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.9|-2.8|
74031459|NCT01128972|147616350|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|11.25|||<|0.0001|TWO_SIDED|95.0|8.22|14.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.29|8.22|<0.0001
73869295|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.646
73869296|NCT00536471|147283063|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.275
73869297|NCT00536471|147283064|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
73869298|NCT00536471|147283064|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline)|Mixed Models Analysis|||||||<0.001
73869299|NCT00536471|147283064|SUPERIORITY_OR_OTHER|||||||0.449||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.449
73869300|NCT00536471|147283064|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.167
73943608|NCT02110901|147420389|SUPERIORITY|||||||0.109|||||||Chi-squared|||||||0.109
73943609|NCT02110901|147420390|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.035
73943610|NCT02634788|147420391|OTHER||LS Mean Difference|81.93|STANDARD_ERROR_OF_MEAN|14.283|<|0.0001|TWO_SIDED|95.0|53.82|110.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||110.04|53.82|<0.0001
73975346|NCT02307682|147496012|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.5|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.5|-5.5|
73943611|NCT02634788|147420391|OTHER||LS Mean Difference|36.18|STANDARD_ERROR_OF_MEAN|14.099||0.0108|TWO_SIDED|95.0|8.43|63.93|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||63.93|8.43|0.0108
73943612|NCT02634788|147420391|OTHER||LS Mean Difference|35.46|STANDARD_ERROR_OF_MEAN|14.02||0.012|TWO_SIDED|95.0|7.86|63.05|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||63.05|7.86|0.0120
73943613|NCT02496767|147420438|SUPERIORITY||Least squares mean difference|1.707|STANDARD_ERROR_OF_MEAN|1.9365||0.3782|TWO_SIDED|95.0|-2.089|5.503|||Repeated-measures mixed model|||||5.503|-2.089|0.3782
73943614|NCT02496767|147420438|SUPERIORITY||Least squares mean difference|0.612|STANDARD_ERROR_OF_MEAN|2.0245||0.7625|TWO_SIDED|95.0|-3.359|4.583|||Repeated-measures mixed model|||||4.583|-3.359|0.7625
73943615|NCT02496767|147420438|SUPERIORITY||Least squares mean difference|0.428|STANDARD_ERROR_OF_MEAN|2.1081||0.8394|TWO_SIDED|95.0|-3.711|4.566|||Repeated-measures mixed model|||||4.566|-3.711|0.8394
73943616|NCT02496767|147420439|SUPERIORITY||Least squares mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.41||0.4521|TWO_SIDED|95.0|-0.5|1.12|||Repeated-measures mixed model|||||1.12|-0.50|0.4521
73943617|NCT02496767|147420439|SUPERIORITY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.426||0.712|TWO_SIDED|95.0|-1.0|0.68|||Repeated-measures mixed model|||||0.68|-1.00|0.7120
73943618|NCT02496767|147420439|SUPERIORITY||Least squares mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.439||0.451|TWO_SIDED|95.0|-1.19|0.53|||Repeated-measures mixed model|||||0.53|-1.19|0.4510
73943619|NCT02496767|147420440|SUPERIORITY||Mean Difference (Final Values)|-0.0011||||0.9505|TWO_SIDED|95.0|-0.0374|0.0351|||Repeated-measures mixed model|||||0.0351|-0.0374|0.9505
73943620|NCT02496767|147420440|SUPERIORITY||Mean Difference (Final Values)|0.0066||||0.7336|TWO_SIDED|95.0|-0.0317|0.045|||Repeated-measures mixed model|||||0.0450|-0.0317|0.7336
73943621|NCT02496767|147420440|SUPERIORITY||Mean Difference (Final Values)|0.0088||||0.6593|TWO_SIDED|95.0|-0.0303|0.0479|||Repeated-measures mixed model|||||0.0479|-0.0303|0.6593
73943622|NCT02496767|147420441|SUPERIORITY||Hazard Ratio (HR)|0.818||||0.2369|TWO_SIDED|95.0|0.587|1.141|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.141|0.587|0.2369
73943623|NCT02496767|147420441|SUPERIORITY||Hazard Ratio (HR)|0.988||||0.942|TWO_SIDED|95.0|0.711|1.372|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.372|0.711|0.9420
73943624|NCT02496767|147420441|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.6853|TWO_SIDED|95.0|0.668|1.304|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.304|0.668|0.6853
73975347|NCT02307682|147496012|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.1|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.3|-5.1|
73943625|NCT02496767|147420442|SUPERIORITY||Hazard Ratio (HR)|1.066||||0.7667|TWO_SIDED|95.0|0.698|1.627|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.627|0.698|0.7667
73943626|NCT02496767|147420442|SUPERIORITY||Hazard Ratio (HR)|0.904||||0.6619|TWO_SIDED|95.0|0.577|1.419|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.419|0.577|0.6619
73943627|NCT02496767|147420442|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.5856|TWO_SIDED|95.0|0.561|1.386|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.386|0.561|0.5856
73975348|NCT02307682|147496012|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-4.3|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||6.7|-4.3|
73943628|NCT02496767|147420443|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.103||0.9991|TWO_SIDED|95.0|-2.17|2.17|||Repeated-measures mixed model|||||2.17|-2.17|0.9991
73943629|NCT02496767|147420443|SUPERIORITY||Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|1.138||0.4808|TWO_SIDED|95.0|-3.04|1.43|||Repeated-measures mixed model|||||1.43|-3.04|0.4808
73943630|NCT02496767|147420443|SUPERIORITY||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.165||0.6082|TWO_SIDED|95.0|-2.89|1.69|||Repeated-measures mixed model|||||1.69|-2.89|0.6082
73943631|NCT02496767|147420444|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.2602|TWO_SIDED|95.0|0.5|1.206|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.206|0.500|0.2602
73943632|NCT02496767|147420444|SUPERIORITY||Hazard Ratio (HR)|1.094||||0.6748|TWO_SIDED|95.0|0.72|1.662|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.662|0.720|0.6748
73943633|NCT02496767|147420444|SUPERIORITY||Hazard Ratio (HR)|0.938||||0.7694|TWO_SIDED|95.0|0.609|1.443|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.443|0.609|0.7694
73943634|NCT04711603|147420472|SUPERIORITY||Placebo difference|-0.97|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.52|-0.42|||MMRM|||||-0.42|-1.52|<0.001
73943635|NCT04270747|147420504|OTHER|A pre-specified similarity margin of (-3, 3) ETDRS letters was used to demonstrate clinical similarity for the mean change from Baseline in BCVA at Week 8.|Difference between means|0.1|||||TWO_SIDED|90.0|-1.1|1.3|||||Estimated using analysis of covariance (ANCOVA) model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||1.3|-1.1|
73943636|NCT04270747|147420505|OTHER||Risk Difference (RD)|-2.1|||||TWO_SIDED|90.0|-5.2|2.2|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who maintained vision at Week 52.||2.2|-5.2|
73943637|NCT04270747|147420505|OTHER||Risk Difference (RD)|-1.7|||||TWO_SIDED|90.0|-6.2|2.8|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who maintained vision at Week 52.||2.8|-6.2|
73869301|NCT00536471|147283065|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.016
73869302|NCT00536471|147283065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||<0.001
73943638|NCT04270747|147420506|OTHER||Difference between means|-0.1|||||TWO_SIDED|90.0|-1.3|1.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 4.||1.2|-1.3|
73943639|NCT04270747|147420506|OTHER||Difference between means|-0.8|||||TWO_SIDED|90.0|-2.3|0.7|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||0.7|-2.3|
73943640|NCT04270747|147420506|OTHER||Difference between means|-0.3|||||TWO_SIDED|90.0|-1.9|1.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 16.||1.2|-1.9|
73943641|NCT04270747|147420506|OTHER||Difference between means|0.4|||||TWO_SIDED|90.0|-1.3|2.1|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 24.||2.1|-1.3|
73943642|NCT04270747|147420506|OTHER||Difference between means|-1.3|||||TWO_SIDED|90.0|-3.1|0.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 32.||0.5|-3.1|
73943643|NCT04270747|147420506|OTHER||Difference between means|-0.5|||||TWO_SIDED|90.0|-2.3|1.4|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 40.||1.4|-2.3|
73943644|NCT04270747|147420506|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-3.2|0.8|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 48.||0.8|-3.2|
73943645|NCT04270747|147420506|OTHER||Difference between means|-1.5|||||TWO_SIDED|2.0|-3.4|0.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 52.||0.5|-3.4|
73943646|NCT04270747|147420506|OTHER||Difference between means|-1.5|||||TWO_SIDED|90.0|-3.0|0.0|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 4.||0.0|-3.0|
73943647|NCT04270747|147420506|OTHER||Difference between means|-1.9|||||TWO_SIDED|90.0|-3.6|-0.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||-0.2|-3.6|
73943648|NCT04270747|147420506|OTHER||Difference between means|-0.3|||||TWO_SIDED|90.0|-2.1|1.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 16.||1.5|-2.1|
73943649|NCT04270747|147420506|OTHER||Difference between means|0.0|||||TWO_SIDED|90.0|-1.9|2.0|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 24.||2.0|-1.9|
73943650|NCT04270747|147420506|OTHER||Difference between means|-1.9|||||TWO_SIDED|90.0|-4.0|0.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 32.||0.2|-4.0|
73943651|NCT04270747|147420506|OTHER||Difference between means|0.0|||||TWO_SIDED|90.0|-2.2|2.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 40.||2.2|-2.2|
73943652|NCT04270747|147420506|OTHER||Difference between means|-0.6|||||TWO_SIDED|90.0|-2.9|1.7|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 48.||1.7|-2.9|
73943653|NCT04270747|147420506|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-3.5|1.1|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 52.||1.1|-3.5|
73943654|NCT04270747|147420507|OTHER||Risk Difference (RD)|-3.4|||||TWO_SIDED|90.0|-9.8|3.1|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 10 letters of vision at Week 8.||3.1|-9.8|
73943655|NCT04270747|147420508|OTHER||Risk Difference (RD)|-5.3|||||TWO_SIDED|90.0|-13.6|2.5|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52.||2.5|-13.6|
73943656|NCT04270747|147420508|OTHER||Risk Difference (RD)|-5.2|||||TWO_SIDED|90.0|-14.4|4.2|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52.||4.2|-14.4|
73943657|NCT04270747|147420509|OTHER||Difference between means|-0.048|||||TWO_SIDED|90.0|-0.734|0.638|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||0.638|-0.734|
73943658|NCT04270747|147420509|OTHER||Difference between means|0.431|||||TWO_SIDED|90.0|-0.367|1.229|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||1.229|-0.367|
73943659|NCT04270747|147420509|OTHER||Difference between means|0.197|||||TWO_SIDED|90.0|-0.625|1.019|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||1.019|-0.625|
73943660|NCT04270747|147420509|OTHER||Difference between means|0.156|||||TWO_SIDED|2.0|-0.561|0.872|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||0.872|-0.561|
73943661|NCT04270747|147420509|OTHER||Difference between means|0.105|||||TWO_SIDED|90.0|-0.682|0.891|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||0.891|-0.682|
73943662|NCT04270747|147420509|OTHER||Difference between means|0.245|||||TWO_SIDED|90.0|-0.667|1.158|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||1.158|-0.667|
73943663|NCT04270747|147420509|OTHER||Difference between means|-0.116|||||TWO_SIDED|90.0|-1.065|0.834|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||0.834|-1.065|
73943664|NCT04270747|147420509|OTHER||Difference between means|0.647|||||TWO_SIDED|90.0|-0.186|1.479|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||1.479|-0.186|
73943665|NCT04270747|147420510|OTHER||Difference between means|6.2|||||TWO_SIDED|90.0|-5.6|17.9|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 4.||17.9|-5.6|
73943666|NCT04270747|147420510|OTHER||Difference between means|1.3|||||TWO_SIDED|90.0|-11.0|13.5|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||13.5|-11.0|
73943667|NCT04270747|147420510|OTHER||Difference between means|1.9|||||TWO_SIDED|90.0|-12.9|16.6|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||16.6|-12.9|
73943668|NCT04270747|147420510|OTHER||Difference between means|0.1|||||TWO_SIDED|90.0|-14.1|14.4|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||14.4|-14.1|
73943669|NCT04270747|147420510|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-15.3|12.9|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 32.||12.9|-15.3|
73943670|NCT04270747|147420510|OTHER||Difference between means|0.2|||||TWO_SIDED|90.0|-13.7|14.1|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 40.||14.1|-13.7|
73869303|NCT00536471|147283065|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.653
73943671|NCT04270747|147420510|OTHER||Difference between means|7.0|||||TWO_SIDED|90.0|-7.4|21.4|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 48.||21.4|-7.4|
73943672|NCT04270747|147420510|OTHER||Difference between means|1.6|||||TWO_SIDED|2.0|-9.3|12.5|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||12.5|-9.3|
73943673|NCT04270747|147420510|OTHER||Difference between means|6.3|||||TWO_SIDED|90.0|-7.4|20.0|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 4.||20.0|-7.4|
74031460|NCT01128972|147616350|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.56|||<|0.0001|TWO_SIDED|95.0|8.53|14.6||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.60|8.53|<0.0001
74031461|NCT01128972|147616351|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.88||||0.7041|TWO_SIDED|95.0|-5.46|3.69||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR and Test dentifrice+ Test MR treatment regimen treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||3.69|-5.46|0.7041
73943674|NCT04270747|147420510|OTHER||Difference between means|-5.1|||||TWO_SIDED|90.0|-19.3|9.1|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||9.1|-19.3|
73943675|NCT04270747|147420510|OTHER||Difference between means|-3.8|||||TWO_SIDED|90.0|-20.9|13.3|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||13.3|-20.9|
73943676|NCT04270747|147420510|OTHER||Difference between means|-6.0|||||TWO_SIDED|90.0|-22.6|10.6|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||10.6|-22.6|
73943677|NCT04270747|147420510|OTHER||Difference between means|-7.0|||||TWO_SIDED|90.0|-23.3|9.3|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 32.||9.3|-23.3|
73943678|NCT04270747|147420510|OTHER||Difference between means|-6.5|||||TWO_SIDED|90.0|-22.8|9.8|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 40.||9.8|-22.8|
73943679|NCT04270747|147420510|OTHER||Difference between means|-0.5|||||TWO_SIDED|90.0|-17.3|16.2|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 48.||16.2|-17.3|
73943680|NCT04270747|147420510|OTHER||Difference between means|2.3|||||TWO_SIDED|90.0|-10.5|15.0|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||15.0|-10.5|
73943681|NCT01984697|147420604|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the Geometric Mean Titer (GMT) ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.15|||<|0.001|TWO_SIDED|95.0|1.83|2.53|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.53|1.83|<0.001
73943682|NCT01984697|147420604|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.02|||<|0.001|TWO_SIDED|95.0|1.73|2.36|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.36|1.73|<0.001
73943683|NCT01984697|147420604|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.47|||<|0.001|TWO_SIDED|95.0|2.93|4.11|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.11|2.93|<0.001
73943684|NCT01984697|147420605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.8|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.8|<0.001
73943685|NCT01984697|147420605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.0|<0.001
73869304|NCT00536471|147283065|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.417
73943686|NCT01984697|147420605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
73943687|NCT01984697|147420606|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.39|||<|0.001|TWO_SIDED|95.0|2.03|2.82|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.82|2.03|<0.001
73943688|NCT01984697|147420606|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.45|||<|0.001|TWO_SIDED|95.0|2.09|2.88|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.88|2.09|<0.001
73943689|NCT01984697|147420606|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|5.07|||<|0.001|TWO_SIDED|95.0|4.32|5.94|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.94|4.32|<0.001
73943690|NCT01984697|147420607|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.54|||<|0.001|TWO_SIDED|95.0|2.14|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.00|2.14|<0.001
73943691|NCT01984697|147420607|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.69|||<|0.001|TWO_SIDED|95.0|2.29|3.15|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.15|2.29|<0.001
73943692|NCT01984697|147420607|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|4.54|||<|0.001|TWO_SIDED|95.0|3.84|5.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.37|3.84|<0.001
73943693|NCT01984697|147420608|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.46|||<|0.001|TWO_SIDED|95.0|2.05|2.96|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.96|2.05|<0.001
73943694|NCT01984697|147420608|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.44|||<|0.001|TWO_SIDED|95.0|2.04|2.92|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.92|2.04|<0.001
73943695|NCT01984697|147420608|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.69|||<|0.001|TWO_SIDED|95.0|3.06|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.45|3.06|<0.001
73943696|NCT01984697|147420609|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.51|||<|0.001|TWO_SIDED|95.0|2.1|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.00|2.10|<0.001
73943697|NCT01984697|147420609|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.62|||<|0.001|TWO_SIDED|95.0|2.2|3.12|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.12|2.20|<0.001
73943698|NCT01984697|147420609|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.7|||<|0.001|TWO_SIDED|95.0|3.08|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.45|3.08|<0.001
73869305|NCT00536471|147283066|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.204
73943699|NCT01984697|147420610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.96|||<|0.001|TWO_SIDED|95.0|2.5|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.50|2.50|<0.001
73975349|NCT02307682|147496012|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.6|-5.2|
73943700|NCT01984697|147420610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.99|||<|0.001|TWO_SIDED|95.0|2.55|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.50|2.55|<0.001
73943701|NCT01984697|147420610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|6.31|||<|0.001|TWO_SIDED|95.0|5.36|7.43|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||7.43|5.36|<0.001
73975350|NCT02307682|147496012|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.6|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.4|-4.6|
73975351|NCT02307682|147496012|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-4.7|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.3|-4.7|
73975352|NCT02307682|147496012|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.2|-4.8|
73975353|NCT02307682|147496012|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.2|-4.8|
73943702|NCT01984697|147420611|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|1.67|||<|0.001|TWO_SIDED|95.0|1.38|2.03|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.03|1.38|<0.001
73943703|NCT01984697|147420611|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.65|||<|0.001|TWO_SIDED|95.0|1.37|1.99|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||1.99|1.37|<0.001
73943704|NCT01984697|147420611|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.96|||<|0.001|TWO_SIDED|95.0|1.61|2.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.37|1.61|<0.001
73943705|NCT01984697|147420612|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.36|1.87|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||1.87|1.36|<0.001
73943706|NCT01984697|147420612|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.51|2.05|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.05|1.51|<0.001
73943707|NCT01984697|147420612|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.08|||<|0.001|TWO_SIDED|95.0|2.64|3.61|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.61|2.64|<0.001
73943708|NCT01984697|147420613|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.55|||<|0.001|TWO_SIDED|95.0|2.15|3.01|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.01|2.15|<0.001
73943709|NCT01984697|147420613|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.7|||<|0.001|TWO_SIDED|95.0|2.3|3.16|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.16|2.30|<0.001
73943710|NCT01984697|147420613|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|4.98|||<|0.001|TWO_SIDED|95.0|4.23|5.86|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.86|4.23|<0.001
73943711|NCT01984697|147420614|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
73943712|NCT01984697|147420614|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.0|<0.001
73943713|NCT01984697|147420614|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
73943714|NCT01984697|147420615|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
73943715|NCT01984697|147420615|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
73975354|NCT02307682|147496012|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-3.1|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||7.7|-3.1|
74039453|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.15||0.1495|TWO_SIDED|95.0|-0.5|0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.08|-0.50|0.1495
73943716|NCT01984697|147420615|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
73943717|NCT01984697|147420616|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
73975355|NCT02307682|147496012|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-2.9|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.7|-2.9|
73943718|NCT01984697|147420616|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
73943719|NCT01984697|147420616|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
73943720|NCT01984697|147420617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.8|-1.7|<0.001
73943721|NCT01984697|147420617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
73943722|NCT01984697|147420617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
73943723|NCT01984697|147420618|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.7|-1.7|<0.001
73943724|NCT01984697|147420618|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.0|<0.001
73869306|NCT00536471|147283066|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
73943725|NCT01984697|147420618|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.1|<0.001
73943726|NCT01984697|147420619|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.4|||<|0.001|TWO_SIDED|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.0|-0.7|<0.001
73943727|NCT01984697|147420619|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.4|||<|0.001|TWO_SIDED|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.0|-0.7|<0.001
73943728|NCT01984697|147420619|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|2.1|||<|0.001|TWO_SIDED|95.0|0.7|4.6|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.6|0.7|<0.001
73943729|NCT01984697|147420620|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.7|-1.7|<0.001
73943730|NCT01984697|147420620|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
73975356|NCT02307682|147496012|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.5|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.4|-4.5|
73975357|NCT02307682|147496012|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-4.6|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.4|-4.6|
73975358|NCT02307682|147496012|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-4.5|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.9|-4.5|
74039454|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.0123|TWO_SIDED|95.0|-0.65|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.08|-0.65|0.0123
73975359|NCT02307682|147496012|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-4.5|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.4|-4.5|
73975360|NCT02307682|147496012|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-3.1|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||8.7|-3.1|
73975361|NCT02307682|147496012|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-4.7|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.2|-4.7|
73975362|NCT02307682|147496013|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.7|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.5|-7.7|
73975363|NCT02307682|147496013|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-8.5|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.8|-8.5|
73975364|NCT02307682|147496013|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-8.9|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.6|-8.9|
73975365|NCT02307682|147496013|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.6|-7.7|
73975366|NCT02307682|147496013|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.9|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-8.9|
73975367|NCT02307682|147496013|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-10.0|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.0|-10.0|
73975368|NCT02307682|147496013|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.3|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||5.5|-6.3|
73975369|NCT02307682|147496013|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-6.2|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.4|-6.2|
73975370|NCT02307682|147496013|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-10.4|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.0|-10.4|
73975371|NCT02307682|147496013|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.4|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.8|-9.4|
73975372|NCT02307682|147496013|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.6|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.9|-4.6|
73975373|NCT02307682|147496013|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||5.7|-6.6|
73869307|NCT00536471|147283066|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
73975374|NCT02307682|147496013|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.5|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.7|-6.5|
73975375|NCT02307682|147496013|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.9|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.4|-4.9|
73869308|NCT00536471|147283066|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.133
73943731|NCT01984697|147420620|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
73943732|NCT01984697|147420621|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
73943733|NCT01984697|147420621|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
73943734|NCT01984697|147420621|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.1|<0.001
73943735|NCT00847405|147420626|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.64||||||90.0|95.93|111.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111.97|95.93|
73975376|NCT02307682|147496013|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-3.9|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||7.5|-3.9|
73975377|NCT02307682|147496013|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.0|11.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||11.5|-1.0|
73975378|NCT02307682|147496013|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.4|-8.5|
73975379|NCT02307682|147496013|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-6.0|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.4|-6.0|
73975380|NCT02307682|147496013|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.2|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.4|-5.2|
73975381|NCT02307682|147496013|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-7.4|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.0|-7.4|
73975382|NCT02307682|147496013|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.5|-8.8|
73975383|NCT02307682|147496013|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.4|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-8.4|
73975384|NCT02307682|147496013|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-9.5|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.3|-9.5|
73975385|NCT02307682|147496013|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.6|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.6|-8.6|
73975386|NCT02307682|147496013|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.2|-8.8|
73869309|NCT00536471|147283067|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.023
73869310|NCT00536471|147283067|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.100
73869311|NCT00536471|147283067|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
73943736|NCT00847405|147420627|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.81||||||90.0|97.95|107.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.91|97.95|
73869312|NCT00536471|147283067|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.133
73869313|NCT00536471|147283068|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.332
73943737|NCT00847405|147420628|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.25||||||90.0|98.35|108.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.41|98.35|
73943738|NCT00514683|147420656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.052||0.853|TWO_SIDED|95.0|-0.086|0.118||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.118|-0.086|0.8530
73943739|NCT00514683|147420656|SUPERIORITY_OR_OTHER|||||||0.7558||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.7558
73975387|NCT02307682|147496013|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.1|-6.8|
73975388|NCT02307682|147496013|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.9|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.1|-5.9|
73975389|NCT02307682|147496013|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.0|-6.6|
73975390|NCT02307682|147496013|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-5.7|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.4|-5.7|
73975391|NCT02307682|147496013|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.1|-9.0|
73975392|NCT02307682|147496013|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-7.2|5.5||Hypothesis testing not pre-specified.|Regression, Logistic|||Week 64||5.5|-7.2|
73975393|NCT02307682|147496013|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.7|-6.6|
73975394|NCT02307682|147496013|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.3|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.3|-4.3|
73975395|NCT02307682|147496013|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.3|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.1|-6.3|
73975396|NCT02307682|147496013|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-7.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.6|-7.2|
73869314|NCT00536471|147283068|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.041
73869315|NCT00536471|147283068|SUPERIORITY_OR_OTHER|||||||0.775||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.775
73975397|NCT02307682|147496013|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.5|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.3|-8.5|
73975398|NCT02307682|147496013|OTHER||Difference in proportions|4.0|||||TWO_SIDED|95.0|-2.4|10.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||10.2|-2.4|
73975399|NCT02307682|147496013|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.1|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.8|-5.1|
73869316|NCT00536471|147283068|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.588
73975400|NCT02307682|147496013|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-2.5|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||9.6|-2.5|
73943740|NCT00514683|147420656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.792|TWO_SIDED|95.0|-0.119|0.08||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.080|-0.119|0.7920
73869317|NCT00536471|147283069|SUPERIORITY_OR_OTHER|||||||0.624||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.624
73943741|NCT00514683|147420656|SUPERIORITY_OR_OTHER|||||||0.6991||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.6991
73943742|NCT00514683|147420656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.051||0.853|TWO_SIDED|95.0|-0.071|0.128||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.128|-0.071|0.8530
73943743|NCT00514683|147420656|SUPERIORITY_OR_OTHER|||||||0.5736||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.5736
73943744|NCT00514683|147420656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.053||0.0639|TWO_SIDED|95.0|0.027|0.235||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.235|0.027|0.0639
73943745|NCT00514683|147420656|SUPERIORITY_OR_OTHER|||||||0.0136||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.0136
73943746|NCT00514683|147420657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.43|STANDARD_ERROR_OF_MEAN|1.312||0.2774|TWO_SIDED|95.0|-1.15|4.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.01|-1.15|0.2774
73943747|NCT00514683|147420657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|1.312||0.4014|TWO_SIDED|95.0|-1.48|3.68|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.68|-1.48|0.4014
73943748|NCT00514683|147420657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|1.324||0.0314|TWO_SIDED|95.0|0.26|5.46|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.46|0.26|0.0314
73943749|NCT00514683|147420657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|1.319||0.0002|TWO_SIDED|95.0|2.37|7.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.56|2.37|0.0002
73943750|NCT00514683|147420658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.046||0.3644|TWO_SIDED|95.0|-0.05|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.13|-0.05|0.3644
73943751|NCT00514683|147420658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.046||0.4525|TWO_SIDED|95.0|-0.06|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.13|-0.06|0.4525
73943752|NCT00514683|147420658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.046||0.0471|TWO_SIDED|95.0|0.0|0.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.18|0.00|0.0471
73943753|NCT00514683|147420658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.046||0.0004|TWO_SIDED|95.0|0.08|0.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.26|0.08|0.0004
73943754|NCT00514683|147420659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|1.702||0.592|TWO_SIDED|95.0|-2.43|4.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.26|-2.43|0.5920
73943755|NCT00514683|147420659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.702||0.6155|TWO_SIDED|95.0|-2.49|4.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.20|-2.49|0.6155
73943756|NCT00514683|147420659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.81|STANDARD_ERROR_OF_MEAN|1.716||0.0271|TWO_SIDED|95.0|0.43|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.18|0.43|0.0271
73943757|NCT00514683|147420659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.47|STANDARD_ERROR_OF_MEAN|1.71||0.0015|TWO_SIDED|95.0|2.11|8.83|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||8.83|2.11|0.0015
73943758|NCT00514683|147420660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|1.692||0.5601|TWO_SIDED|95.0|-2.34|4.31||ANCOVA with fixed terms for treatment, baseline, region.|ANCOVA||Mean difference to placebo is calculated. Negative change indicates worsening.|||4.31|-2.34|0.5601
73943759|NCT00514683|147420660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.694||0.6366|TWO_SIDED|95.0|-2.53|4.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.13|-2.53|0.6366
73943760|NCT00514683|147420660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|STANDARD_ERROR_OF_MEAN|1.702||0.0246|TWO_SIDED|95.0|0.49|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.18|0.49|0.0246
73943761|NCT00514683|147420660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.44|STANDARD_ERROR_OF_MEAN|1.7||0.0015|TWO_SIDED|95.0|2.1|8.78|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||8.78|2.10|0.0015
73943762|NCT00514683|147420661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.911||||0.7543|TWO_SIDED|95.0|0.506|1.637|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.637|0.506|0.7543
73943763|NCT00514683|147420661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.6704|TWO_SIDED|95.0|0.631|2.045|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.045|0.631|0.6704
73943764|NCT00514683|147420661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.657||||0.1649|TWO_SIDED|95.0|0.363|1.189|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.189|0.363|0.1649
73943765|NCT00514683|147420661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.415||||0.0041|TWO_SIDED|95.0|0.227|0.757|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||0.757|0.227|0.0041
73943766|NCT00514683|147420662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.278||||0.5882|TWO_SIDED|95.0|0.526|3.102|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||3.102|0.526|0.5882
73943767|NCT00514683|147420662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.0653|TWO_SIDED|95.0|0.078|1.081|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.081|0.078|0.0653
73943768|NCT00514683|147420662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.0847|TWO_SIDED|95.0|0.106|1.154|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.154|0.106|0.0847
73975401|NCT02307682|147496013|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-3.5|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||9.0|-3.5|
73943769|NCT00514683|147420662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732||||0.5383|TWO_SIDED|95.0|0.271|1.977|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.977|0.271|0.5383
73975402|NCT02307682|147496013|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.0|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.0|-3.0|
73975403|NCT02307682|147496013|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||6.4|-5.8|
73975404|NCT02307682|147496013|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-6.6|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.5|-6.6|
73943770|NCT00514683|147420663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.483||0.3658|TWO_SIDED|95.0|-0.51|1.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.39|-0.51|0.3658
73943771|NCT00514683|147420663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.478||0.4956|TWO_SIDED|95.0|-0.61|1.27|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.27|-0.61|0.4956
73943772|NCT00514683|147420663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.482||0.0051|TWO_SIDED|95.0|0.41|2.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.31|0.41|0.0051
73869318|NCT00536471|147283069|SUPERIORITY_OR_OTHER|||||||0.473||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.473
73869319|NCT00536471|147283069|SUPERIORITY_OR_OTHER|||||||0.787||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.787
73943773|NCT00514683|147420663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.483||0.0211|TWO_SIDED|95.0|0.17|2.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.07|0.17|0.0211
73869320|NCT00536471|147283069|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.086
73869321|NCT00536471|147283070|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.099
73943774|NCT00514683|147420664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.428||||0.1021|TWO_SIDED|95.0|0.155|1.184|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.184|0.155|0.1021
73943775|NCT00514683|147420664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.682||||0.4318|TWO_SIDED|95.0|0.262|1.773|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.773|0.262|0.4318
73975405|NCT02307682|147496013|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.0|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.1|-6.0|
73943776|NCT00514683|147420664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.412||||0.0934|TWO_SIDED|95.0|0.146|1.161|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.161|0.146|0.0934
73943777|NCT00514683|147420664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.313||||0.0317|TWO_SIDED|95.0|0.108|0.903|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||0.903|0.108|0.0317
73975406|NCT02307682|147496013|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-2.8|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||9.5|-2.8|
73975407|NCT02307682|147496013|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-4.3|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.0|-4.3|
73975408|NCT02307682|147496013|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.7|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.8|-4.7|
73975409|NCT02307682|147496013|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.8|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||9.0|-3.8|
73869322|NCT00536471|147283070|SUPERIORITY_OR_OTHER|||||||0.223||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.223
73869323|NCT00536471|147283070|SUPERIORITY_OR_OTHER|||||||0.473||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.473
73869324|NCT00536471|147283070|SUPERIORITY_OR_OTHER|||||||0.233||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.233
73869325|NCT00536471|147283071|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.577
73869326|NCT00536471|147283071|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.567
73869327|NCT00536471|147283072|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.670
73943778|NCT00514683|147420665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|2.33||0.6443|TWO_SIDED|95.0|-5.66|3.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.51|-5.66|0.6443
73943779|NCT00514683|147420665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|2.28||0.5656|TWO_SIDED|95.0|-5.8|3.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.18|-5.80|0.5656
74031462|NCT01128972|147616351|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.78|||<|0.0001|TWO_SIDED|95.0|6.21|15.36||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||15.36|6.21|<0.0001
73943780|NCT00514683|147420665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|2.24||0.9181|TWO_SIDED|95.0|-4.18|4.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.64|-4.18|0.9181
73943781|NCT00514683|147420665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|2.387||0.697|TWO_SIDED|95.0|-3.77|5.63|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.63|-3.77|0.6970
73943782|NCT00514683|147420666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|2.49||0.9811|TWO_SIDED|95.0|-4.84|4.96|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.96|-4.84|0.9811
73943783|NCT00514683|147420666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|2.412||0.6772|TWO_SIDED|95.0|-3.74|5.75|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.75|-3.74|0.6772
73943784|NCT00514683|147420666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|2.379||0.8631|TWO_SIDED|95.0|-4.27|5.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.09|-4.27|0.8631
73943785|NCT00514683|147420666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|STANDARD_ERROR_OF_MEAN|2.523||0.5942|TWO_SIDED|95.0|-3.62|6.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||6.31|-3.62|0.5942
73943786|NCT00514683|147420667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.715||0.2716|TWO_SIDED|95.0|-0.62|2.19|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.19|-0.62|0.2716
73943787|NCT00514683|147420667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.696||0.7871|TWO_SIDED|95.0|-1.18|1.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.56|-1.18|0.7871
73943788|NCT00514683|147420667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.685||0.8721|TWO_SIDED|95.0|-1.46|1.24|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.24|-1.46|0.8721
73943789|NCT00514683|147420667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.734||0.8523|TWO_SIDED|95.0|-1.58|1.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.31|-1.58|0.8523
73943790|NCT00514683|147420668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.093||||0.7997|TWO_SIDED|95.0|0.549|2.175|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.175|0.549|0.7997
73943791|NCT00514683|147420668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.916||||0.7989|TWO_SIDED|95.0|0.467|1.797|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.797|0.467|0.7989
73943792|NCT00514683|147420668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4596|TWO_SIDED|95.0|0.403|1.508|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.508|0.403|0.4596
73943793|NCT00514683|147420668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.665||||0.2548|TWO_SIDED|95.0|0.33|1.341|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.341|0.330|0.2548
73943794|NCT00514683|147420669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.051||||0.8887|TWO_SIDED|95.0|0.521|2.122|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.122|0.521|0.8887
73943795|NCT00514683|147420669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.216||||0.5758|TWO_SIDED|95.0|0.613|2.41|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.410|0.613|0.5758
74039455|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.0307|TWO_SIDED|95.0|-0.71|-0.03|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.03|-0.71|0.0307
73943796|NCT00514683|147420669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.993||||0.9829|TWO_SIDED|95.0|0.506|1.949|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.949|0.506|0.9829
73943797|NCT00514683|147420669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.972||||0.9375|TWO_SIDED|95.0|0.476|1.985|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.985|0.476|0.9375
73943798|NCT00514683|147420670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.1456||0.4998|TWO_SIDED|95.0|-0.188|0.385|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.385|-0.188|0.4998
74031463|NCT01128972|147616351|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|25.72|||<|0.0001|TWO_SIDED|95.0|21.14|30.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||30.29|21.14|<0.0001
73869328|NCT00536471|147283072|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.059
73869329|NCT00536471|147283072|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.930
73869330|NCT00536471|147283072|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.567
73869331|NCT00536471|147283073|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.896
73869332|NCT00536471|147283073|SUPERIORITY_OR_OTHER|||||||0.796||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.796
73869333|NCT00536471|147283073|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
73943799|NCT00514683|147420670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.155|STANDARD_ERROR_OF_MEAN|0.1399||0.2679|TWO_SIDED|95.0|-0.43|0.12|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.120|-0.430|0.2679
73943800|NCT00514683|147420670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5678|TWO_SIDED|95.0|-0.355|0.195|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.195|-0.355|0.5678
73943801|NCT00514683|147420670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.1448||0.4053|TWO_SIDED|95.0|-0.406|0.164|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.164|-0.406|0.4053
73943802|NCT00514683|147420671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.892||||0.7307|TWO_SIDED|95.0|0.465|1.71|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.710|0.465|0.7307
73943803|NCT00514683|147420671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.317||||0.3869|TWO_SIDED|95.0|0.706|2.458|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.458|0.706|0.3869
73975410|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-24.2|8.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||8.4|-24.2|
73975411|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-31.9|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||-1.1|-31.9|
73869334|NCT00536471|147283073|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.381
73869335|NCT00536471|147283074|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.038
73869336|NCT00536471|147283074|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
73869337|NCT00536471|147283074|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.665
73869338|NCT00536471|147283074|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.253
73869339|NCT00536471|147283075|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
73943804|NCT00514683|147420671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.931||||0.8237|TWO_SIDED|95.0|0.498|1.741|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.741|0.498|0.8237
73975412|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|8.51|||TWO_SIDED|95.0|-30.4|3.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||3.0|-30.4|
73943805|NCT00514683|147420671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.676||||0.1177|TWO_SIDED|95.0|0.878|3.202|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||3.202|0.878|0.1177
73943806|NCT00514683|147420672|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-11.24|STANDARD_ERROR_OF_MEAN|17.089||0.5111|TWO_SIDED|95.0|-44.86|22.37|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||22.37|-44.86|0.5111
73943807|NCT00514683|147420672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.17|STANDARD_ERROR_OF_MEAN|16.234||0.4176|TWO_SIDED|95.0|-45.11|18.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||18.76|-45.11|0.4176
73943808|NCT00514683|147420672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|16.506||0.9454|TWO_SIDED|95.0|-33.6|31.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||31.34|-33.60|0.9454
73943809|NCT00514683|147420672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.32|STANDARD_ERROR_OF_MEAN|16.98||0.7101|TWO_SIDED|95.0|-27.08|39.72|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||39.72|-27.08|0.7101
73943810|NCT00514683|147420673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.2271||0.809|TWO_SIDED|95.0|-0.392|0.502|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.502|-0.392|0.8090
73943811|NCT00514683|147420673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182|STANDARD_ERROR_OF_MEAN|0.2158||0.3995|TWO_SIDED|95.0|-0.606|0.242|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.242|-0.606|0.3995
73943812|NCT00514683|147420673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.2193||0.8822|TWO_SIDED|95.0|-0.399|0.464|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.464|-0.399|0.8822
73943813|NCT00514683|147420673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.2257||0.5338|TWO_SIDED|95.0|-0.584|0.303|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.303|-0.584|0.5338
73943814|NCT00514683|147420674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.3272||0.7329|TWO_SIDED|95.0|-0.532|0.755|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.755|-0.532|0.7329
73943815|NCT00514683|147420674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.3109||0.8009|TWO_SIDED|95.0|-0.69|0.533|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.533|-0.690|0.8009
73943816|NCT00514683|147420674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3159||0.6358|TWO_SIDED|95.0|-0.771|0.472|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.472|-0.771|0.6358
73943817|NCT00514683|147420674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.333|STANDARD_ERROR_OF_MEAN|0.3252||0.3064|TWO_SIDED|95.0|-0.973|0.307|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.307|-0.973|0.3064
73943818|NCT00514683|147420675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||0.9646|TWO_SIDED|95.0|0.54|1.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||1.906|0.540|0.9646
73943819|NCT00514683|147420675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.994||||0.985|TWO_SIDED|95.0|0.536|1.844|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||1.844|0.536|0.9850
73943820|NCT00514683|147420675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.7136|TWO_SIDED|95.0|0.604|2.089|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||2.089|0.604|0.7136
73943821|NCT00514683|147420675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.551||||0.1705|TWO_SIDED|95.0|0.828|2.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||2.906|0.828|0.1705
73975413|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|8.16|||TWO_SIDED|95.0|-35.0|-2.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||-2.9|-35.0|
73975414|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-36.3|-3.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||-3.1|-36.3|
73975415|NCT02307682|147496014|OTHER||Least Squares Mean Difference|-24.5|STANDARD_ERROR_OF_MEAN|8.24|||TWO_SIDED|95.0|-40.7|-8.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-8.3|-40.7|
74089236|NCT02697773|147731602|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0023|TWO_SIDED|95.0|-1.2|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-1.20|0.0023
73975416|NCT02307682|147496014|SUPERIORITY||Least Squares Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|9.24||0.0159|TWO_SIDED|95.0|-38.0|-1.7||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||-1.7|-38.0|0.0159
73975417|NCT02307682|147496014|SUPERIORITY||Least Squares Mean Difference|-27.8|STANDARD_ERROR_OF_MEAN|8.8||0.0008|TWO_SIDED|95.0|-45.1|-10.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||-10.5|-45.1|0.0008
73975418|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|8.69|||TWO_SIDED|95.0|-11.8|22.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||22.3|-11.8|
73975419|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|8.8|||TWO_SIDED|95.0|-14.1|20.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||20.5|-14.1|
73975420|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-25.8|STANDARD_ERROR_OF_MEAN|9.44|||TWO_SIDED|95.0|-44.3|-7.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||-7.2|-44.3|
73975421|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-29.6|STANDARD_ERROR_OF_MEAN|9.13|||TWO_SIDED|95.0|-47.5|-11.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||-11.6|-47.5|
73975422|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|8.96|||TWO_SIDED|95.0|-29.2|5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||5.9|-29.2|
73975423|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|8.98|||TWO_SIDED|95.0|-29.8|5.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||5.5|-29.8|
73975424|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-20.1|STANDARD_ERROR_OF_MEAN|9.91|||TWO_SIDED|95.0|-39.6|-0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||-0.7|-39.6|
73975425|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|9.64|||TWO_SIDED|95.0|-42.1|-4.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||-4.2|-42.1|
73975426|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|9.24|||TWO_SIDED|95.0|-35.5|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||0.7|-35.5|
73975427|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-19.6|STANDARD_ERROR_OF_MEAN|9.14|||TWO_SIDED|95.0|-37.6|-1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||-1.7|-37.6|
73975428|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|9.83|||TWO_SIDED|95.0|-46.6|-8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||-8.0|-46.6|
73975429|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-29.5|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-48.2|-10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||-10.9|-48.2|
73975430|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|9.27|||TWO_SIDED|95.0|-27.5|8.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||8.9|-27.5|
73869340|NCT00536471|147283075|SUPERIORITY_OR_OTHER|||||||0.312||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.312
73869341|NCT00536471|147283075|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.853
73869342|NCT00536471|147283075|SUPERIORITY_OR_OTHER|||||||0.913||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.913
73869343|NCT00536471|147283076|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.234
73869344|NCT00536471|147283076|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.216
73869345|NCT00536471|147283076|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.853
73869346|NCT00536471|147283076|SUPERIORITY_OR_OTHER|||||||0.908||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.908
73869347|NCT00536471|147283077|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.789
73869348|NCT00536471|147283077|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.012
73869349|NCT00536471|147283077|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.414
73943822|NCT00514683|147420676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.68||0.0479|TWO_SIDED|95.0|-2.69|-0.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.01|-2.69|0.0479
73943823|NCT00514683|147420676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.68||0.0685|TWO_SIDED|95.0|-2.58|0.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||0.09|-2.58|0.0685
73943824|NCT00514683|147420676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.684||0.0099|TWO_SIDED|95.0|-3.12|-0.43|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.43|-3.12|0.0099
73943825|NCT00514683|147420676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.683||0.0152|TWO_SIDED|95.0|-3.01|-0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.32|-3.01|0.0152
73943826|NCT00514683|147420677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|2.253||0.725|TWO_SIDED|95.0|-5.22|3.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||3.64|-5.22|0.7250
73975431|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|9.64|||TWO_SIDED|95.0|-30.3|7.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||7.5|-30.3|
73975432|NCT02307682|147496014|SUPERIORITY||Least Squares Mean Difference|-23.9|STANDARD_ERROR_OF_MEAN|9.79||0.0075|TWO_SIDED|95.0|-43.1|-4.6||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||-4.6|-43.1|0.0075
73975433|NCT02307682|147496014|SUPERIORITY||Least Squares Mean Difference|-29.0|STANDARD_ERROR_OF_MEAN|9.47||0.0012|TWO_SIDED|95.0|-47.6|-10.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||-10.4|-47.6|0.0012
73975434|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-15.6|STANDARD_ERROR_OF_MEAN|9.17|||TWO_SIDED|95.0|-33.6|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||2.4|-33.6|
73869350|NCT00536471|147283077|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.717
73869351|NCT00536471|147283078|SUPERIORITY_OR_OTHER|||||||0.78||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.780
73869352|NCT00536471|147283078|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.152
73943827|NCT00514683|147420677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.28|STANDARD_ERROR_OF_MEAN|2.213||0.1389|TWO_SIDED|95.0|-7.63|1.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.07|-7.63|0.1389
73869353|NCT00536471|147283078|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.637
73943828|NCT00514683|147420677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.98|STANDARD_ERROR_OF_MEAN|2.221||0.0741|TWO_SIDED|95.0|-8.35|0.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.39|-8.35|0.0741
73975435|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-15.1|STANDARD_ERROR_OF_MEAN|9.35|||TWO_SIDED|95.0|-33.4|3.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||3.3|-33.4|
73943829|NCT00514683|147420677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.12|STANDARD_ERROR_OF_MEAN|2.262||0.0071|TWO_SIDED|95.0|-10.57|-1.67|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-1.67|-10.57|0.0071
73943830|NCT00514683|147420678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|3.183||0.337|TWO_SIDED|95.0|-9.32|3.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||3.20|-9.32|0.3370
73943831|NCT00514683|147420678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.34|STANDARD_ERROR_OF_MEAN|3.126||0.1659|TWO_SIDED|95.0|-10.49|1.81|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.81|-10.49|0.1659
73943832|NCT00514683|147420678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.12|STANDARD_ERROR_OF_MEAN|3.138||0.1897|TWO_SIDED|95.0|-10.29|2.05|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||2.05|-10.29|0.1897
73943833|NCT00514683|147420678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|3.184||0.0028|TWO_SIDED|95.0|-15.86|-3.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-3.34|-15.86|0.0028
73943834|NCT00514683|147420679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.586||0.8458|TWO_SIDED|95.0|-5.59|4.58|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||4.58|-5.59|0.8458
73943835|NCT00514683|147420679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|2.54||0.3286|TWO_SIDED|95.0|-7.48|2.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||2.51|-7.48|0.3286
73943836|NCT00514683|147420679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|2.548||0.1799|TWO_SIDED|95.0|-8.43|1.59|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.59|-8.43|0.1799
73943837|NCT00514683|147420679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.35|STANDARD_ERROR_OF_MEAN|2.597||0.0948|TWO_SIDED|95.0|-9.46|0.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.76|-9.46|0.0948
73943838|NCT00514683|147420680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|2.484||0.9708|TWO_SIDED|95.0|-4.98|4.79|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||4.79|-4.98|0.9708
74031464|NCT01128972|147616351|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|36.29|||<|0.0001|TWO_SIDED|95.0|31.71|40.86||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and Placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||40.86|31.71|<0.0001
74039456|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0009|TWO_SIDED|95.0|-0.91|-0.24|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.24|-0.91|0.0009
73943839|NCT00514683|147420680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|2.44||0.1069|TWO_SIDED|95.0|-8.74|0.85|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.85|-8.74|0.1069
73975436|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|9.62|||TWO_SIDED|95.0|-38.9|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||-1.1|-38.9|
73869354|NCT00536471|147283078|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.024
73943840|NCT00514683|147420680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.49|STANDARD_ERROR_OF_MEAN|2.453||0.0682|TWO_SIDED|95.0|-9.31|0.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.34|-9.31|0.0682
73943841|NCT00514683|147420680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.16|STANDARD_ERROR_OF_MEAN|2.494||0.0043|TWO_SIDED|95.0|-12.06|-2.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-2.26|-12.06|0.0043
73943842|NCT00514683|147420681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.2698|TWO_SIDED|95.0|0.72|3.31|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||3.31|0.72|0.2698
73943843|NCT00514683|147420681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.0891|TWO_SIDED|95.0|0.9|4.01|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||4.01|0.90|0.0891
73943844|NCT00514683|147420681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.0069|TWO_SIDED|95.0|1.29|5.66|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||5.66|1.29|0.0069
73943845|NCT00514683|147420681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0341|TWO_SIDED|95.0|1.05|4.61|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||4.61|1.05|0.0341
73943846|NCT00514683|147420682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.1015||0.8288|TWO_SIDED|95.0|-0.178|0.222|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.222|-0.178|0.8288
73943847|NCT00514683|147420682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.0974||0.1506|TWO_SIDED|95.0|-0.051|0.332|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.332|-0.051|0.1506
73943848|NCT00514683|147420682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.0977||0.1059|TWO_SIDED|95.0|-0.034|0.351|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.351|-0.034|0.1059
73943849|NCT00514683|147420682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.358|STANDARD_ERROR_OF_MEAN|0.1008||0.0004|TWO_SIDED|95.0|0.16|0.556|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.556|0.160|0.0004
73943850|NCT00514683|147420683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.068||0.7789|TWO_SIDED|95.0|-0.153|0.115|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.115|-0.153|0.7789
73943851|NCT00514683|147420683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.0652||0.3149|TWO_SIDED|95.0|-0.063|0.194|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.194|-0.063|0.3149
73943852|NCT00514683|147420683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.0654||0.7062|TWO_SIDED|95.0|-0.104|0.153|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.153|-0.104|0.7062
73943853|NCT00514683|147420683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.0675||0.0703|TWO_SIDED|95.0|-0.01|0.255|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.255|-0.010|0.0703
73943854|NCT00514683|147420684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.0884||0.4792|TWO_SIDED|95.0|-0.111|0.236|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.236|-0.111|0.4792
73975437|NCT02307682|147496014|OTHER||Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|9.86|||TWO_SIDED|95.0|-39.4|-0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||-0.7|-39.4|
73975438|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-18.8|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-37.0|-0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||-0.5|-37.0|
73975439|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-31.4|6.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||6.1|-31.4|
73975440|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|95.0|-46.7|-7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||-7.6|-46.7|
73975441|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-22.5|STANDARD_ERROR_OF_MEAN|9.73|||TWO_SIDED|95.0|-41.6|-3.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||-3.4|-41.6|
73975442|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-14.9|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|95.0|-33.8|3.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||3.9|-33.8|
73869355|NCT00536471|147283079|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.517
73943855|NCT00514683|147420684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.0839||0.2221|TWO_SIDED|95.0|-0.062|0.268|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.268|-0.062|0.2221
73943856|NCT00514683|147420684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.0843||0.151|TWO_SIDED|95.0|-0.044|0.287|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.287|-0.044|0.1510
73869356|NCT00536471|147283079|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.256
73869357|NCT00536471|147283079|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
73975443|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-13.2|STANDARD_ERROR_OF_MEAN|9.88|||TWO_SIDED|95.0|-32.6|6.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||6.2|-32.6|
73975444|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|9.89|||TWO_SIDED|95.0|-49.3|-10.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||-10.5|-49.3|
73975445|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-26.4|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-46.0|-6.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||-6.8|-46.0|
73975446|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|9.62|||TWO_SIDED|95.0|-38.2|-0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||-0.4|-38.2|
73943857|NCT00514683|147420684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337|STANDARD_ERROR_OF_MEAN|0.0874||0.0001|TWO_SIDED|95.0|0.165|0.509|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.509|0.165|0.0001
73975447|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-35.0|3.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||3.7|-35.0|
74039457|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.2103|TWO_SIDED|95.0|-0.51|0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.11|-0.51|0.2103
73943858|NCT00514683|147420685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.0609||0.1129|TWO_SIDED|95.0|-0.023|0.217|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.217|-0.023|0.1129
73943859|NCT00514683|147420685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.0584||0.1498|TWO_SIDED|95.0|-0.031|0.199|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.199|-0.031|0.1498
73943860|NCT00514683|147420685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.0585||0.0632|TWO_SIDED|95.0|-0.006|0.224|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.224|-0.006|0.0632
73943861|NCT00514683|147420685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.0604||0.0009|TWO_SIDED|95.0|0.083|0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.320|0.083|0.0009
73943862|NCT00514683|147420686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.0676||0.6306|TWO_SIDED|95.0|-0.165|0.1|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.100|-0.165|0.6306
73943863|NCT00514683|147420686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.065||0.7426|TWO_SIDED|95.0|-0.149|0.106|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.106|-0.149|0.7426
73975448|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|10.34|||TWO_SIDED|95.0|-45.0|-4.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||-4.5|-45.0|
73975449|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|10.32|||TWO_SIDED|95.0|-43.9|-3.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||-3.4|-43.9|
73869358|NCT00536471|147283079|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
73943864|NCT00514683|147420686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.0651||0.9209|TWO_SIDED|95.0|-0.134|0.121|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.121|-0.134|0.9209
73943865|NCT00514683|147420686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.0671||0.7701|TWO_SIDED|95.0|-0.112|0.152|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.152|-0.112|0.7701
73975450|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|9.65|||TWO_SIDED|95.0|-38.4|-0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||-0.5|-38.4|
73975451|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|10.05|||TWO_SIDED|95.0|-31.5|8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||8.0|-31.5|
73975452|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|10.16|||TWO_SIDED|95.0|-47.3|-7.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||-7.4|-47.3|
73975453|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|10.22|||TWO_SIDED|95.0|-44.3|-4.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||-4.2|-44.3|
73975454|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-15.1|STANDARD_ERROR_OF_MEAN|9.7|||TWO_SIDED|95.0|-34.2|3.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||3.9|-34.2|
73975455|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-12.5|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-32.1|7.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||7.1|-32.1|
73975456|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-30.9|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-50.6|-11.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||-11.3|-50.6|
73975457|NCT02307682|147496014|OTHER|Treatment difference|Least Squares Mean Difference|-26.0|STANDARD_ERROR_OF_MEAN|10.28|||TWO_SIDED|95.0|-46.2|-5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-5.9|-46.2|
73975458|NCT02307682|147496015|SUPERIORITY||Least Squares Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|9.29||0.0183|TWO_SIDED|95.0|-37.7|-1.2||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||-1.2|-37.7|0.0183
73975459|NCT02307682|147496015|SUPERIORITY||Least Squares Mean Difference|-22.4|STANDARD_ERROR_OF_MEAN|9.19||0.0075|TWO_SIDED|95.0|-40.4|-4.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-4.4|-40.4|0.0075
73975460|NCT02307682|147496016|OTHER|Treatment difference|Least Squares Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|9.76|||TWO_SIDED|95.0|-42.4|-4.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||-4.1|-42.4|
73869359|NCT00536471|147283080|SUPERIORITY_OR_OTHER|||||||0.741||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.741
73975461|NCT02307682|147496016|OTHER|Treatment difference|Least Squares Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-38.3|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.0|-38.3|
73869360|NCT00536471|147283080|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.722
73975462|NCT02307682|147496017|OTHER|Treatment difference|Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|8.5|||TWO_SIDED|95.0|-32.6|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48||0.7|-32.6|
73975463|NCT02307682|147496017|OTHER|Treatment difference|Least Squares Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-36.5|-3.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||-3.3|-36.5|
73975464|NCT02307682|147496017|OTHER|Treatment difference|Least Squares Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|8.87|||TWO_SIDED|95.0|-36.4|-1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96||-1.5|-36.4|
73975465|NCT02307682|147496017|OTHER|Treatment difference|Least Squares Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|8.93|||TWO_SIDED|95.0|-36.9|-1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||-1.8|-36.9|
73869361|NCT00536471|147283080|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
73869362|NCT00536471|147283080|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
73869363|NCT00536471|147283081|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
73869364|NCT00536471|147283081|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.949
73869365|NCT00536471|147283081|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
73869366|NCT00536471|147283081|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
73869367|NCT00536471|147283082|SUPERIORITY_OR_OTHER|||||||0.682||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.682
73975466|NCT02307682|147496018|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-0.8|0.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||0.1|-0.8|
73975467|NCT02307682|147496018|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.0|-0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-0.2|-1.0|
73869368|NCT00536471|147283082|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.001
73943866|NCT00514683|147420687|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.6671|TWO_SIDED|95.0|0.36|1.93||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.93|0.36|0.6671
73943867|NCT00514683|147420687|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8||||0.5926|TWO_SIDED|95.0|0.34|1.84||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.84|0.34|0.5926
73869369|NCT00536471|147283082|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.200
73869370|NCT00536471|147283082|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.813
73869371|NCT00536471|147283083|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.438
73943868|NCT00514683|147420687|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.1381|TWO_SIDED|95.0|0.18|1.27||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.27|0.18|0.1381
73975468|NCT02307682|147496018|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-1.1|-0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||-0.2|-1.1|
73869372|NCT00536471|147283083|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.018
73869373|NCT00536471|147283083|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
73869374|NCT00536471|147283083|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
73869375|NCT00536471|147283084|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.588
73869376|NCT00536471|147283084|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.758
73869377|NCT00536471|147283084|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
73975469|NCT02307682|147496018|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.9|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||0.0|-0.9|
73975470|NCT02307682|147496018|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.3|-0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||-0.3|-1.3|
73975471|NCT02307682|147496018|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-1.1|-0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-0.3|-1.1|
73975472|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.31|||TWO_SIDED|95.0|-3.3|17.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||17.5|-3.3|
73975473|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|5.37|||TWO_SIDED|95.0|-10.2|10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||10.9|-10.2|
73975474|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|5.35|||TWO_SIDED|95.0|-8.4|12.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||12.6|-8.4|
74031465|NCT01128972|147616352|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.39||||0.0049|TWO_SIDED|95.0|-7.43|-1.35||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Test dentifrice + Test MR to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||-1.35|-7.43|0.0049
73869378|NCT00536471|147283084|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
73869379|NCT00536471|147283085|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.507
73975475|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|5.52|||TWO_SIDED|95.0|-12.5|9.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||9.2|-12.5|
73975476|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.38|||TWO_SIDED|95.0|-11.2|10.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||10.0|-11.2|
73975477|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|5.55|||TWO_SIDED|95.0|-13.9|7.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||7.9|-13.9|
73975478|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-11.1|11.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||11.4|-11.1|
73975479|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-16.1|6.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||6.5|-16.1|
73975480|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|9.3|STANDARD_ERROR_OF_MEAN|5.56|||TWO_SIDED|95.0|-1.6|20.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||20.3|-1.6|
73975481|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|95.0|-3.4|18.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||18.5|-3.4|
73975482|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|5.68|||TWO_SIDED|95.0|-14.7|7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||7.6|-14.7|
73869380|NCT00536471|147283085|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.466
73869381|NCT00536471|147283085|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
73869382|NCT00536471|147283085|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
73869383|NCT00536471|147283086|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.487
73943869|NCT00514683|147420687|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.16||||0.015|TWO_SIDED|95.0|0.03|0.7||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||0.70|0.03|0.0150
73943870|NCT00514683|147420688|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.8282|TWO_SIDED|95.0|0.347|2.336|||Negative binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||2.336|0.347|0.8282
73975483|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-17.9|5.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||5.3|-17.9|
73943871|NCT00514683|147420688|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.5326|TWO_SIDED|95.0|0.278|1.938|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||1.938|0.278|0.5326
73975484|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|5.51|||TWO_SIDED|95.0|-8.8|12.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||12.9|-8.8|
73869384|NCT00536471|147283086|SUPERIORITY_OR_OTHER|||||||0.678||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.678
73943872|NCT00514683|147420688|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.1944|TWO_SIDED|95.0|0.167|1.438|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||1.438|0.167|0.1944
73943873|NCT00514683|147420688|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22||||0.0324|TWO_SIDED|95.0|0.056|0.882|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||0.882|0.056|0.0324
73943874|NCT00514683|147420689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.5206|TWO_SIDED|95.0|0.326|1.765|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.765|0.326|0.5206
73869385|NCT00536471|147283086|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
73975485|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-8.7|13.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||13.8|-8.7|
73975486|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-8.4|14.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||14.1|-8.4|
73869386|NCT00536471|147283086|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
73869387|NCT00536471|147283087|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.505
73975487|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-11.7|11.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||11.5|-11.7|
73975488|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-8.8|13.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||13.6|-8.8|
73975489|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-12.2|10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||10.9|-12.2|
73975490|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|5.71|||TWO_SIDED|95.0|-10.7|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||11.7|-10.7|
73975491|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-15.0|7.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||7.8|-15.0|
73975492|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|5.62|||TWO_SIDED|95.0|-6.1|15.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||15.9|-6.1|
73975493|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-10.0|13.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||13.1|-10.0|
73975494|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-10.5|12.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||12.1|-10.5|
73975495|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.93|||TWO_SIDED|95.0|-12.2|11.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||11.1|-12.2|
73975496|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|5.77|||TWO_SIDED|95.0|-9.5|13.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||13.2|-9.5|
73975497|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|6.04|||TWO_SIDED|95.0|-10.6|13.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||13.1|-10.6|
73975498|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-10.6|12.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||12.4|-10.6|
74031466|NCT01128972|147616352|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28||||0.8571|TWO_SIDED|95.0|-3.31|2.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||2.76|-3.31|0.8571
73975499|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-10.4|13.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||13.5|-10.4|
73975500|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-11.9|11.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||11.2|-11.9|
73975501|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|6.17|||TWO_SIDED|95.0|-9.7|14.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||14.6|-9.7|
73975502|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-11.7|11.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||11.3|-11.7|
73869388|NCT00536471|147283087|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.135
73943875|NCT00514683|147420689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841||||0.6862|TWO_SIDED|95.0|0.362|1.952|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.952|0.362|0.6862
73943876|NCT00514683|147420689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.517||||0.1891|TWO_SIDED|95.0|0.193|1.384|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.384|0.193|0.1891
73943877|NCT00514683|147420689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.158||||0.0161|TWO_SIDED|95.0|0.035|0.711|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||0.711|0.035|0.0161
73943878|NCT00514683|147420690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.173||||0.7449|TWO_SIDED|95.0|0.448|3.072|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||3.072|0.448|0.7449
73943879|NCT00514683|147420690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.316||||0.0925|TWO_SIDED|95.0|0.083|1.209|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.209|0.083|0.0925
73943880|NCT00514683|147420690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19||||0.0379|TWO_SIDED|95.0|0.04|0.911|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||0.911|0.040|0.0379
73943881|NCT00514683|147420690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.225||||0.06|TWO_SIDED|95.0|0.048|1.065|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.065|0.048|0.0600
73943882|NCT00514683|147420691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.055||||0.7883|TWO_SIDED|95.0|0.713|1.563|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.563|0.713|0.7883
73943883|NCT00514683|147420691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958||||0.8293|TWO_SIDED|95.0|0.646|1.419|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.419|0.646|0.8293
73943884|NCT00514683|147420691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.805||||0.303|TWO_SIDED|95.0|0.534|1.216|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.216|0.534|0.3030
73943885|NCT00514683|147420691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.6505|TWO_SIDED|95.0|0.605|1.369|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.369|0.605|0.6505
73943886|NCT00335452|147420693|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|6.1||||0.3037|TWO_SIDED|95.0|-5.8|16.6||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||16.6|-5.8|0.3037
73943887|NCT00335452|147420694|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|logistic regression model including terms for ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI).||||||0.012
73943888|NCT00335452|147420695|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|3.1||||0.6047|TWO_SIDED|95.0|-9.2|14.0||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg) log-rank test.|The relative risk reduction (ASA high dose versus ASA low dose) is estimated using stratified Cox proportional hazards model controlling for Clopidogrel treatment regimen.|||14.0|-9.2|0.6047
73943889|NCT00335452|147420696|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|-6.5||||0.4579|TWO_SIDED|95.0|-26.0|9.9||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.|||9.9|-26.0|0.4579
73943890|NCT00335452|147420696|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|17.6||||0.0262|TWO_SIDED|95.0|2.2|30.5||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.|||30.5|2.2|0.0262
73943891|NCT00335452|147420696|SUPERIORITY_OR_OTHER|||||||0.0355||95.0||||The a priori threshold for statistical significance is ≤0.05.|Chi-squared|Interaction chi-squared test of the Cox proportional hazards model.||||||0.0355
73975503|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|6.09|||TWO_SIDED|95.0|-12.2|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||11.7|-12.2|
73975504|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-9.3|13.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||13.9|-9.3|
73975505|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-9.8|14.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||14.0|-9.8|
73975506|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-14.5|8.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||8.7|-14.5|
73975507|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|6.06|||TWO_SIDED|95.0|-13.7|10.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||10.1|-13.7|
73975508|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|-10.0|13.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||13.7|-10.0|
73975509|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|6.13|||TWO_SIDED|95.0|-12.2|11.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||11.8|-12.2|
73975510|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|-9.1|14.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||14.7|-9.1|
73975511|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|6.01|||TWO_SIDED|95.0|-11.3|12.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||12.3|-11.3|
73975512|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|5.95|||TWO_SIDED|95.0|-11.9|11.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||11.5|-11.9|
73975513|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|6.04|||TWO_SIDED|95.0|-12.0|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||11.7|-12.0|
73975514|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|5.86|||TWO_SIDED|95.0|-13.2|9.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||9.8|-13.2|
74031467|NCT01128972|147616352|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.87|||<|0.0001|TWO_SIDED|95.0|3.83|9.9||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||9.90|3.83|<0.0001
73975515|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-12.6|11.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||11.0|-12.6|
74039458|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.2656|TWO_SIDED|95.0|-0.48|0.13|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.13|-0.48|0.2656
73869389|NCT00536471|147283087|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.175
73975516|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-9.8|13.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||13.3|-9.8|
73975517|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|6.09|||TWO_SIDED|95.0|-11.1|12.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||12.8|-11.1|
73975518|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-15.6|7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||7.6|-15.6|
73975519|NCT02307682|147496019|OTHER|Treatment difference|Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|95.0|-15.8|8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||8.0|-15.8|
73975520|NCT02307682|147496020|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-16.4|-3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-3.3|-16.4|
73869390|NCT00536471|147283087|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
73869391|NCT00536471|147283088|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.175
73869392|NCT00536471|147283088|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
73869393|NCT00536471|147283088|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.576
73869394|NCT00536471|147283088|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.676
73869395|NCT00536471|147283089|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.675
73943892|NCT00335452|147420697|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|14.7||||0.0332|TWO_SIDED|95.0|1.2|26.3||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) Log-rank test. No adjustment was made.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||26.3|1.2|0.0332
73943893|NCT00335452|147420698|SUPERIORITY_OR_OTHER|||||||0.945||95.0||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|Logistic regression model including a term for Clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg).||||||0.945
73943894|NCT00335452|147420699|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|32.6||||0.0004|TWO_SIDED|95.0|16.2|45.8||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||45.8|16.2|0.0004
73943895|NCT02943941|147420700|OTHER|||||||0.429|||||||ANOVA|||||||0.429
73943896|NCT02943941|147420701|OTHER|||||||0.059||||||Pressure during coughing versus normal breathing initially measured at baseline.|ANOVA|||||||0.059
73943897|NCT02943941|147420702|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73975521|NCT02307682|147496020|OTHER||Difference in proportions|-14.2|||||TWO_SIDED|95.0|-21.3|-7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-7.3|-21.3|
74031468|NCT01128972|147616352|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.17|||<|0.0001|TWO_SIDED|95.0|4.14|10.21||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Placebo dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||10.21|4.14|<0.0001
73869396|NCT00536471|147283089|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.139
73869397|NCT00536471|147283089|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.576
73869398|NCT00536471|147283089|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.676
73869399|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.007
73869400|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.031
73869401|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.020
73869402|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.324
73943898|NCT02736825|147420703|NON_INFERIORITY|Non-inferiority margin of 15% between two independent percentages using the z-test with unpooled variance||||||0.367|||||||Z-test|||||||0.3670
73943899|NCT01904864|147420721|SUPERIORITY||Mean Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.4|1.6|||Regression, Linear||Change at 12 weeks compared|||1.6|0.4|<0.001
73975522|NCT02307682|147496020|OTHER||Difference in proportions|-8.4|||||TWO_SIDED|95.0|-14.6|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.2|-14.6|
73869403|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.010
73869404|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.005
73943900|NCT01564368|147420724|SUPERIORITY||area under the curve (AUC)|0.53||||0.484|ONE_SIDED|95.0||0.61||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC1 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.61||0.484
73943901|NCT01564368|147420724|SUPERIORITY||area under the curve|0.6||||0.017|ONE_SIDED|95.0||0.68||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC2 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.68||0.017
73943902|NCT01564368|147420724|SUPERIORITY||area under the curve|0.61||||0.013|ONE_SIDED|95.0||0.69||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) is considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC3 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.69||0.013
73943903|NCT01564368|147420725|SUPERIORITY||area under the curve|0.68|||<|0.001|ONE_SIDED|95.0||0.75||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV1 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.75||<0.001
73975523|NCT02307682|147496020|OTHER||Difference in proportions|-15.0|||||TWO_SIDED|95.0|-20.9|-9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-9.5|-20.9|
73975524|NCT02307682|147496020|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-13.8|-2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.4|-13.8|
73975525|NCT02307682|147496020|OTHER||Difference in proportions|-14.0|||||TWO_SIDED|95.0|-18.9|-8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-8.7|-18.9|
73975526|NCT02307682|147496020|OTHER||Difference in proportions|-10.4|||||TWO_SIDED|95.0|-16.8|-3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-3.7|-16.8|
73975527|NCT02307682|147496020|OTHER||Difference in proportions|-19.7|||||TWO_SIDED|95.0|-25.8|-13.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-13.4|-25.8|
73975528|NCT02307682|147496020|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-2.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.9|-2.0|
73975529|NCT02307682|147496020|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.3|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.9|-4.3|
73943904|NCT01564368|147420725|SUPERIORITY||area under the curve|0.63|||<|0.001|ONE_SIDED|95.0||0.71||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV2 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.71||<0.001
73943905|NCT01564368|147420725|SUPERIORITY||area under the curve|0.68|||<|0.001|ONE_SIDED|95.0||0.75||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV3 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.75||<0.001
73943906|NCT01564368|147420726|EQUIVALENCE|no equivalence margin was used.||||||0.032|||||||z-test|||AUC (optimized) = AUC (ΔADC)||||0.032
73943907|NCT02901626|147420731|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.83|1.2||||||||1.20|0.83|
73943908|NCT02901626|147420732|SUPERIORITY||Median Difference (Net)|2.0|||||TWO_SIDED|95.0|-4.0|8.0||||||||8|-4|
73943909|NCT02901626|147420733|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.06|0.8||||||||0.80|-1.06|
73943910|NCT02901626|147420734|SUPERIORITY||Risk Ratio (RR)|1.26|||||TWO_SIDED|95.0|0.92|1.71||||||||1.71|0.92|
73943911|NCT02901626|147420735|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.93|1.55||||||||1.55|0.93|
73943912|NCT02901626|147420736|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.93|1.45||||||||1.45|0.93|
73943913|NCT02901626|147420737|SUPERIORITY||Risk Ratio (RR)|1.3|||||TWO_SIDED|95.0|0.92|1.82||||||||1.82|0.92|
73943914|NCT02901626|147420738|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.79|1.19||||||||1.19|0.79|
73943915|NCT02901626|147420739|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.61|2.39||||||||2.39|0.61|
73943916|NCT02901626|147420740|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.79|1.31||||||||1.31|0.79|
73943917|NCT02901626|147420741|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.55|2.04||||||||2.04|0.55|
73943918|NCT02901626|147420742|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
73943919|NCT02901626|147420743|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.95|1.94||||||||1.94|0.95|
73943920|NCT02901626|147420744|SUPERIORITY||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|1.0|2.11||||||||2.11|1.00|
73943921|NCT02901626|147420745|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||||1.18|0.88|
74039459|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.16||0.0152|TWO_SIDED|95.0|-0.68|-0.07|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.07|-0.68|0.0152
73943922|NCT02901626|147420746|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|-12.0|12.0||||||||12|-12|
73943923|NCT02901626|147420747|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
73943924|NCT02901626|147420748|SUPERIORITY||Median Difference (Net)|1.0|||||TWO_SIDED|95.0|-12.0|14.0||||||||14|-12|
73943925|NCT02901626|147420749|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.06|15.7||||||||15.7|0.06|
73943926|NCT02901626|147420750|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.25|2.65||||||||2.65|0.25|
73943927|NCT02901626|147420751|SUPERIORITY||Risk Ratio (RR)|0.56|||||TWO_SIDED|95.0|0.17|1.9||||||||1.90|0.17|
73943928|NCT02901626|147420752|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.68|1.96||||||||1.96|0.68|
73943929|NCT02901626|147420753|SUPERIORITY||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.71|1.27||||||||1.27|0.71|
73943930|NCT02901626|147420754|SUPERIORITY||Risk Ratio (RR)|0.72|||||TWO_SIDED|95.0|0.37|1.41||||||||1.41|0.37|
73943931|NCT02901626|147420755|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.39|3.37||||||||3.37|0.39|
73943932|NCT02901626|147420756|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.78|1.29||||||||1.29|0.78|
73943933|NCT02901626|147420757|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.58|1.1||||||||1.10|0.58|
73943934|NCT02901626|147420758|SUPERIORITY||Risk Ratio (RR)|2.45|||||TWO_SIDED|95.0|0.48|12.57||||||||12.57|0.48|
73943935|NCT02901626|147420759|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.27|1.58||||||||1.58|0.27|
73943936|NCT02901626|147420760|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.47|0.97||||||||0.97|0.47|
73943937|NCT02901626|147420761|SUPERIORITY||Risk Ratio (RR)|0.49|||||TWO_SIDED|95.0|0.09|2.66||||||||2.66|0.09|
73943938|NCT02901626|147420762|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.81|1.37||||||||1.37|0.81|
73943939|NCT02901626|147420763|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
73943940|NCT02901626|147420764|SUPERIORITY||Median Difference (Net)|10.0|||||TWO_SIDED|95.0|-16.0|36.0||||||||36|-16|
73943941|NCT00331344|147420767|OTHER||Dose Level VIa|1.0|||||TWO_SIDED||||||||Dose level VIa (mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes, ixabepilone 30mg/m2 IV over 3 hours on day 1, pegfilgrastim 6mg SC on day 2, oral prednisone twice daily on days 1-21) was determined to be MTD, based on 1 event of DLT at VIa.|Cohorts of 3 patients will be enrolled at each dose level; if 1 dose limiting toxicity (DLT) is observed then the cohort will be expanded to 6 patients. If a second DLT is observed, the previous dose level will be considered the MTD. If all observed DLT are due to neuropathy (specific to ixabepilone), then we would consider the previous dose level of Ixabepilone the MTD for that drug, and escalate mitoxantrone hydrochloride as described above to a maximum dose of 12 mg/m\^2.||||
73943942|NCT01373931|147420769|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.976|||||TWO_SIDED|90.0|0.907|1.05|||Mixed Models Analysis|Ratio of Geometric LS mean is for ethinyl estradiol.||||1.05|0.907|
73869405|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.010
73943943|NCT01373931|147420769|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.914|||||TWO_SIDED|90.0|0.842|0.991|||Mixed Models Analysis|Ratio of Geometric LS mean is for norelgestromin.||||0.991|0.842|
73943944|NCT01373931|147420770|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25|||||TWO_SIDED|90.0|-0.73|0.51|||Wilcoxon Signed Rank Test|Median difference is for ethinyl estradiol.||||0.51|-0.73|
73943945|NCT01373931|147420770|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon Signed Rank Test|Median difference is for norelgestromin.||||0.50|-0.50|
73943946|NCT01373931|147420771|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.07||||||90.0|1.0|1.15|||Mixed Models Analysis|Ratio of Geometric LS mean is for ethinyl estradiol.||||1.15|1.00|
73943947|NCT01373931|147420771|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.0||||||90.0|0.944|1.07|||Mixed Models Analysis|Ratio of Geometric LS mean is for norelgestromin.||||1.07|0.944|
73943948|NCT05674890|147420817|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-0.29|STANDARD_DEVIATION|2.49||0.297|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||0.297
73943949|NCT05674890|147420818|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-2.11|STANDARD_DEVIATION|2.81|<|0.001|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||<0.001
73943950|NCT05674890|147420819|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-48.75|STANDARD_DEVIATION|56.48|<|0.001|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||<0.001
73943951|NCT02228967|147420836|OTHER||||||=|0.274||||||A priori threshold for statistical significance was 0.05|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.274
73943952|NCT02228967|147420837|OTHER||||||=|0.083|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.083
73943953|NCT02228967|147420838|OTHER||||||=|0.028|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.028
73943954|NCT02228967|147420839|OTHER||||||=|0.708|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.708
73943955|NCT02228967|147420840|OTHER||||||=|0.197||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tets (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.197
73943956|NCT02228967|147420841|OTHER||||||=|0.023||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.023
73943957|NCT02228967|147420842|OTHER||||||<|0.001||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||<0.001
73943958|NCT02228967|147420843|OTHER||||||=|0.348||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||=0.348
73943959|NCT02228967|147420844|OTHER||Mean Difference (Final Values)|0.345|STANDARD_ERROR_OF_MEAN|0.203||0.091|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.091
73943960|NCT02228967|147420845|OTHER||Mean Difference (Net)|0.393|STANDARD_ERROR_OF_MEAN|0.362||0.278|TWO_SIDED|||||A priori alpha set at 0.05|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||.278
73943961|NCT02228967|147420846|OTHER||Mean Difference (Net)|3.163|STANDARD_ERROR_OF_MEAN|1.44||0.029|TWO_SIDED|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.029
73869406|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.019
73869407|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.201
73869408|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.069
73943962|NCT02228967|147420847|OTHER||Mean Difference (Net)|-0.015||||0.897|TWO_SIDED|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.897
73943963|NCT02228967|147420848|OTHER|||||||0.15|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.15
73943964|NCT02228967|147420849|OTHER|||||||0.2||||||A priori alpha set at 0.05.|Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.20
73943965|NCT02228967|147420850|OTHER|||||||0.38||||||A priori alpha set at 0.05.|Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.38
73943966|NCT02228967|147420851|OTHER|A priori alpha set at 0.05||||||0.48|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.48
73943967|NCT02228967|147420852|OTHER|A priori alpha set at 0.05.||||||0.09|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.09
73943968|NCT02228967|147420853|OTHER|||||||0.08|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.08
73943969|NCT02228967|147420854|OTHER|||||||0.11|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.11
73943970|NCT02228967|147420855|OTHER|||||||0.84|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.84
73943971|NCT00520975|147420856|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.24|TWO_SIDED|95.0|0.43|1.23|||Regression, Cox|||||1.23|0.43|0.24
73943972|NCT00520975|147420857|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.75|TWO_SIDED|95.0|0.61|1.97|||Regression, Cox|||||1.97|0.61|0.75
73943973|NCT04810221|147420867|OTHER|Paired T-test 0|Mean Difference (Final Values)|0.18||||0.31|TWO_SIDED|95.0|-0.17|0.54|||Paired T-test 0||||Additional statistical analysis were: Bland Altman plot and linear regression analysis.|0.54|-0.17|0.31
73943974|NCT04810221|147420868|OTHER|Paired T test 0|Mean Difference (Final Values)|0.25||||0.32|TWO_SIDED|95.0|-0.24|0.75|||Paired T test 0||||Additional statistical analysis were: Bland Altman plot and linear regression analysis.|0.75|-0.24|0.32
73943975|NCT00105235|147420881|SUPERIORITY_OR_OTHER||Proportion|0.22|||||TWO_SIDED|95.0|0.086|0.423|||Exact Binomial Confidence Interval|||||.423|.086|
73869409|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.368
73869410|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.435
73869411|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.090
73943976|NCT00105235|147420882|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.3|||Exact Binomial Confidence Interval|||||0.3|0|
73943977|NCT00105235|147420884|SUPERIORITY_OR_OTHER||Proportion|0.2|||||TWO_SIDED|95.0|0.04|0.3|||Exact Binomial Confidence Interval|||||0.3|0.04|
73943978|NCT00105235|147420885|SUPERIORITY_OR_OTHER||Proportion|0.1|||||TWO_SIDED|95.0|0.01|0.2|||Exact Binomial Confidence Interval|||||0.2|0.01|
73943979|NCT02347657|147420890|SUPERIORITY||Least Squares (LS) Mean Difference|4.0|||<|0.0001|TWO_SIDED|95.0|3.1|4.8|||Mixed model for repeated measures (MMRM)|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||4.8|3.1|<0.0001
73943980|NCT02347657|147420891|SUPERIORITY||LS mean difference|6.8|||<|0.0001|TWO_SIDED|95.0|5.3|8.3|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||8.3|5.3|<0.0001
73943981|NCT02347657|147420892|SUPERIORITY||Event Rate Ratio|0.65||||0.0054|TWO_SIDED|95.0|0.48|0.88|||Negative Binomial Regression|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||0.88|0.48|0.0054
73943982|NCT02347657|147420893|SUPERIORITY||LS mean difference|0.06||||0.4127|TWO_SIDED|95.0|-0.08|0.19|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||0.19|-0.08|0.4127
73957998|NCT03368001|147451528|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|-0.0002|||>|0.05|TWO_SIDED|90.0|-0.054|0.061||One-sided hypothesis test|Structural Equation Model (SEM)|Controlling for SRS-2 Social Communication at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up SRS Communication. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.061|-0.054|>0.05
73869412|NCT00536471|147283090|SUPERIORITY_OR_OTHER|||||||0.313||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.313
73869413|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.639
73869414|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.584||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.584
73869415|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.251||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.251
73869416|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.265||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.265
73943983|NCT00261495|147420903|NON_INFERIORITY_OR_EQUIVALENCE|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|0.29||||0.011||95.0|-0.27|0.84||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|LS mean difference has been presented, which was calculated as hydromorphone minus oxycodone.|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."||0.84|-0.27|0.011
73943984|NCT00261495|147420904|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.706||95.0|-0.32|0.47||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure was stopped here, subsequent tests were exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.47|-0.32|0.706
73943985|NCT00261495|147420905|NON_INFERIORITY_OR_EQUIVALENCE|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.53|0.29||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."||0.29|-0.53|<0.001
73943986|NCT00261495|147420906|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.87||||0.065||95.0|-5.94|0.19||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.19|-5.94|0.065
73957999|NCT03368001|147451529|OTHER|||||||0.49||||||SRS Communication Posttest.|Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||||||.490
73958000|NCT03368001|147451530|OTHER|Posttest ANCOVA controlling for pre-test scores||||||0.704|||||||ANCOVA|||||||0.704
73958001|NCT03368001|147451530|OTHER|Followup ANCOVA controlling for pretest values||||||0.406|||||||ANCOVA|||||||0.406
73869417|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.366
73869418|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.257
73869419|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.426||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.426
73869420|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.234
73869421|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.765
73869422|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.522||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.522
73869423|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.986
73975530|NCT02307682|147496020|OTHER||Difference in proportions|-12.7|||||TWO_SIDED|95.0|-19.1|-6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-6.0|-19.1|
73975531|NCT02307682|147496020|OTHER||Difference in proportions|-23.4|||||TWO_SIDED|95.0|-29.7|-17.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-17.6|-29.7|
73975532|NCT02307682|147496020|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-8.7|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.4|-8.7|
73975533|NCT02307682|147496020|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-11.2|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||0.4|-11.2|
73975534|NCT02307682|147496020|OTHER||Difference in proportions|-7.7|||||TWO_SIDED|95.0|-14.3|-1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-1.0|-14.3|
73975535|NCT02307682|147496020|OTHER||Difference in proportions|-12.4|||||TWO_SIDED|95.0|-19.3|-6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-6.2|-19.3|
73975536|NCT02307682|147496020|OTHER||Difference in proportions|-7.8|||||TWO_SIDED|95.0|-13.2|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.2|-13.2|
73975537|NCT02307682|147496020|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-15.9|-4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-4.9|-15.9|
73975538|NCT02307682|147496020|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-11.5|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||0.9|-11.5|
73975539|NCT02307682|147496020|OTHER||Difference in proportions|-11.4|||||TWO_SIDED|95.0|-17.7|-5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-5.6|-17.7|
73975540|NCT02307682|147496020|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.1|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.7|-5.1|
73975541|NCT02307682|147496020|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.7|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||2.4|-8.7|
73975542|NCT02307682|147496020|OTHER||Difference in proportions|-11.6|||||TWO_SIDED|95.0|-17.8|-5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-5.5|-17.8|
73975543|NCT02307682|147496020|OTHER||Difference in proportions|-15.6|||||TWO_SIDED|95.0|-21.2|-9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-9.7|-21.2|
74039460|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.19||0.5164|TWO_SIDED|95.0|-0.5|0.25|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.25|-0.50|0.5164
74031469|NCT01128972|147616353|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.94|||||TWO_SIDED|95.0|10.36|19.51||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen andReference Dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||19.51|10.36|
74031470|NCT01128972|147616354|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.14|||<|0.0001|TWO_SIDED|95.0|4.11|10.18||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||10.18|4.11|<0.0001
74031471|NCT01663740|147616357|SUPERIORITY_OR_OTHER||Mean Difference|-40.166|STANDARD_ERROR_OF_MEAN|14.1387||0.0075|TWO_SIDED|95.0|-68.869|-11.463|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to EOT|||-11.463|-68.869|0.0075
74031472|NCT01663740|147616358|SUPERIORITY_OR_OTHER||Mean Difference|1.758|STANDARD_ERROR_OF_MEAN|2.646||0.5109|TWO_SIDED|95.0|-3.619|7.135|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to EOT|||7.135|-3.619|0.5109
74031473|NCT01663740|147616358|SUPERIORITY_OR_OTHER||Mean Difference|-1.051|STANDARD_ERROR_OF_MEAN|3.2058||0.7449|TWO_SIDED|95.0|-7.566|5.464|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to end of FU|||5.464|-7.566|0.7449
73943987|NCT00261495|147420907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.348||95.0|-0.62|0.22||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.22|-0.62|0.348
73943988|NCT00261495|147420908|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.616||95.0|-0.54|0.32||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.32|-0.54|0.616
73943989|NCT00261495|147420909|SUPERIORITY_OR_OTHER|||||||0.249||||||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Hierarchical testing procedure has been stopped, test is exploratory in nature.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-squared statistic stratified for country was used.||"Null hypothesis: There is no association between study medication and dose escalation.~Alternative hypothesis: There is an association between study medication and dose escalation."||||0.249
73943990|NCT00261495|147420910|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.05||95.0|0.0|0.84||0.05 two-sided testing, exploratory comparison|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.84|-0.00|0.050
73943991|NCT00261495|147420911|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.105||95.0|-0.06|0.67||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.67|-0.06|0.105
73943992|NCT00261495|147420912|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.058||95.0|-0.01|0.79||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.79|-0.01|0.058
73943993|NCT00261495|147420913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.21||95.0|-0.13|0.59||0.05 two-sided test|ANCOVA||Mean difference calculated: hdromorphone minus oxycodone|Exploratory comparison||0.59|-0.13|0.210
73943994|NCT00261495|147420914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.941||95.0|-4.87|4.52||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.52|-4.87|0.941
73943995|NCT00261495|147420915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31||||0.073||95.0|-0.03|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.65|-0.03|0.073
74031474|NCT01663740|147616359|SUPERIORITY_OR_OTHER||Mean Difference|2.869|STANDARD_ERROR_OF_MEAN|3.2934||0.394|TWO_SIDED|95.0|-4.001|9.739|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from EOT to end of FU|||9.739|-4.001|0.3940
73943996|NCT00261495|147420916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.431||95.0|-0.52|0.22||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.22|-0.52|0.431
73975544|NCT02307682|147496020|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-8.0|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.0|-8.0|
73975545|NCT02307682|147496020|OTHER||Difference in proportions|-8.6|||||TWO_SIDED|95.0|-13.7|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||-3.4|-13.7|
73975546|NCT02307682|147496020|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.6|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-0.7|-12.6|
73975547|NCT02307682|147496020|OTHER||Difference in proportions|-9.6|||||TWO_SIDED|95.0|-16.0|-3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-3.8|-16.0|
73869424|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.602
73975548|NCT02307682|147496020|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-9.9|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||0.7|-9.9|
73975549|NCT02307682|147496020|OTHER||Difference in proportions|-8.5|||||TWO_SIDED|95.0|-13.9|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-3.4|-13.9|
73975550|NCT02307682|147496020|OTHER||Difference in proportions|-7.4|||||TWO_SIDED|95.0|-13.1|-1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-1.2|-13.1|
73975551|NCT02307682|147496020|OTHER||Difference in proportions|-12.0|||||TWO_SIDED|95.0|-17.8|-6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-6.0|-17.8|
73975552|NCT02307682|147496020|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-2.5|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.4|-2.5|
73975553|NCT02307682|147496020|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-6.7|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.7|-6.7|
73975554|NCT02307682|147496020|OTHER||Difference in proportions|-7.5|||||TWO_SIDED|95.0|-12.8|-1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.6|-12.8|
73975555|NCT02307682|147496020|OTHER||Difference in proportions|-12.5|||||TWO_SIDED|95.0|-18.2|-7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-7.0|-18.2|
73975556|NCT02307682|147496020|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.0|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.5|-7.0|
73975557|NCT02307682|147496020|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.4|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||-0.7|-11.4|
73975558|NCT02307682|147496020|OTHER||Difference in proportions|-6.1|||||TWO_SIDED|95.0|-11.8|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-0.1|-11.8|
73943997|NCT00261495|147420917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.835||95.0|-0.4|0.33||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.33|-0.40|0.835
73975559|NCT02307682|147496020|OTHER||Difference in proportions|-11.7|||||TWO_SIDED|95.0|-17.0|-6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-6.4|-17.0|
73975560|NCT02307682|147496020|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.1|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.1|-10.1|
73943998|NCT00261495|147420918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.837||95.0|-5.36|4.35||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.35|-5.36|0.837
73943999|NCT00261495|147420919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.832||95.0|-0.38|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.31|-0.38|0.832
73944000|NCT00261495|147420920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.143||95.0|-0.1|0.71||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.71|-0.10|0.143
73944001|NCT00261495|147420921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.345||95.0|-0.23|0.64||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.64|-0.23|0.345
73869425|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.110
73944002|NCT00261495|147420922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.552||95.0|-0.33|0.61||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.61|-0.33|0.552
73944003|NCT00261495|147420923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.042||95.0|0.02|0.93||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.93|0.02|0.042
73944004|NCT00261495|147420924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.171||95.0|-0.14|0.81||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.81|-0.14|0.171
73944005|NCT00261495|147420925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.475||95.0|-0.31|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.65|-0.31|0.475
73944006|NCT00261495|147420926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.359||95.0|-0.26|0.72||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.72|-0.26|0.359
73944007|NCT00261495|147420927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.611||95.0|-0.52|0.3||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.30|-0.52|0.611
73944008|NCT00261495|147420928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.526||95.0|-0.6|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.31|-0.60|0.526
73944009|NCT00261495|147420929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.769||95.0|-0.49|0.36||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.36|-0.49|0.769
73944010|NCT00261495|147420930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.843||95.0|-0.4|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.49|-0.40|0.843
73975561|NCT02307682|147496020|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.0|0.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||-0.0|-10.0|
73944011|NCT00261495|147420931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.977||95.0|-0.45|0.44||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.44|-0.45|0.977
73944012|NCT00261495|147420932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.977||95.0|-0.47|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.49|-0.47|0.977
73944013|NCT00261495|147420933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.902||95.0|-0.51|0.45||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.45|-0.51|0.902
73944014|NCT00261495|147420935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.36||||0.169||95.0|-5.74|1.02||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.02|-5.74|0.169
73944015|NCT00261495|147420936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.245||95.0|-5.09|1.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.31|-5.09|0.245
74031475|NCT01663740|147616360|SUPERIORITY_OR_OTHER||Mean Difference|0.155|STANDARD_ERROR_OF_MEAN|0.3687||0.6773|TWO_SIDED|95.0|-0.594|0.903|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Basline to EOT|||0.903|-0.594|0.6773
74031476|NCT01663740|147616360|SUPERIORITY_OR_OTHER||Mean Difference|-0.128|STANDARD_ERROR_OF_MEAN|0.3343||0.7046|TWO_SIDED|95.0|-0.806|0.551|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Baseline to end of FU|||0.551|-0.806|0.7046
73869426|NCT00536471|147283091|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.505
73944016|NCT00261495|147420937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.64||||0.071||95.0|-5.51|0.23||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.23|-5.51|0.071
73944017|NCT00261495|147420938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.03||||0.297||95.0|-5.85|1.8||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.80|-5.85|0.297
73944018|NCT00261495|147420939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.41||||0.205||95.0|-1.32|6.14||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||6.14|-1.32|0.205
73944019|NCT00261495|147420940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.35||||0.107||95.0|-7.43|0.73||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.73|-7.43|0.107
73944020|NCT00261495|147420941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.475||95.0|-2.8|6.0||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||6.00|-2.80|0.475
73944021|NCT00261495|147420942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.16||||0.02||95.0|-7.67|-0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||-0.65|-7.67|0.020
73944022|NCT00261495|147420943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.88||95.0|-0.3|0.26||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.26|-0.30|0.880
73944023|NCT00261495|147420944|SUPERIORITY_OR_OTHER|||||||0.32|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.320
73944024|NCT00261495|147420949|SUPERIORITY_OR_OTHER|||||||0.575|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.575
73944025|NCT00261495|147420950|SUPERIORITY_OR_OTHER|||||||0.807|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.807
73944026|NCT00261495|147420951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.61||||0.118||95.0|-5.88|0.67|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.67|-5.88|0.118
73869427|NCT00536471|147283092|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.366
73869428|NCT00536471|147283092|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.065
73944027|NCT00261495|147420952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.956||95.0|-3.08|2.91|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.91|-3.08|0.956
73944028|NCT00261495|147420953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.299||95.0|-0.08|0.26|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.26|-0.08|0.299
73944029|NCT00261495|147420954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.471||95.0|-4.2|1.95|||ANCOVA||Mean difference calculated: hydromorphone minus oxymorphone|Exploratory comparison||1.95|-4.20|0.471
73944030|NCT00261495|147420955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.84||||0.025||95.0|0.48|7.19|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.19|0.48|0.025
73944031|NCT00261495|147420956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.556||95.0|-5.61|10.42|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||10.42|-5.61|0.556
73944032|NCT00261495|147420957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.12||||0.551||95.0|-9.11|4.88|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.88|-9.11|0.551
73944033|NCT00261495|147420958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.98||||0.207||95.0|-7.63|1.66|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.66|-7.63|0.207
73944034|NCT00261495|147420959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.46||||0.123||95.0|-5.6|0.68|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.68|-5.60|0.123
73944035|NCT00261495|147420960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.602||95.0|-4.27|2.48|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.48|-4.27|0.602
73944036|NCT00261495|147420961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65||||0.647||95.0|-2.14|3.44|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||3.44|-2.14|0.647
73944037|NCT00261495|147420962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.627||95.0|-0.17|0.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.10|-0.17|0.627
73944038|NCT00261495|147420963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.414||95.0|-4.45|1.84|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.84|-4.45|0.414
73944039|NCT00261495|147420964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.05||||0.01||95.0|0.94|7.16|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.16|0.94|0.010
73944040|NCT00261495|147420965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.955||95.0|-7.2|7.62|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.62|-7.20|0.955
73944041|NCT00261495|147420966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.31||||0.669||95.0|-4.72|7.34|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.34|-4.72|0.669
73944042|NCT00261495|147420967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.17||||0.595||95.0|-3.15|5.49|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||5.49|-3.15|0.595
73944043|NCT00261495|147420968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94||||0.543||95.0|-3.98|2.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.10|-3.98|0.543
73944044|NCT01059630|147420983|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.4|0.7|||Log Rank|||||0.70|0.40|<0.0001
73944045|NCT01059630|147420985|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.45|0.73|||Log Rank|||||0.73|0.45|<0.0001
73944046|NCT01059630|147420986|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|0.98||||0.9298|TWO_SIDED|95.0|0.58|1.65|||Cochran-Mantel-Haenszel|||||1.65|0.58|0.9298
73944047|NCT01059630|147420987|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|-0.9||||0.7857|TWO_SIDED|95.0|-8.44|6.64|||Cochran-Mantel-Haenszel|||||6.64|-8.44|0.7857
73944048|NCT01059630|147420992|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|2.24||||0.8347|TWO_SIDED|95.0|-7.2|11.69|||Cochran-Mantel-Haenszel|||||11.69|-7.20|0.8347
73944049|NCT01059630|147420993|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|8.55||||0.0466|TWO_SIDED|95.0|-0.22|17.32|||Cochran-Mantel-Haenszel|||||17.32|-0.22|0.0466
73944050|NCT01059630|147420994|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.31|0.61||||||||0.61|0.31|
73944051|NCT01059630|147420995|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.39|0.67||||||||0.67|0.39|
73944052|NCT01059630|147420996|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.13|||||TWO_SIDED|95.0|0.04|0.45||||||||0.45|0.04|
73944053|NCT01059630|147420997|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.29|0.81||||||||0.81|0.29|
73944054|NCT01059630|147420998|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.0001|TWO_SIDED|95.0|0.44|0.74|||Log Rank|||||0.74|0.44|0.0001
73944055|NCT01059630|147421000|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.081|TWO_SIDED|95.0|0.57|1.03|||Log Rank|||||1.03|0.57|0.0810
73944056|NCT05614089|147421050|SUPERIORITY|||||||0.43||||||Since this is one of two coprimary outcomes (this outcome and % time-in-range), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in serious hypoglycemia at baseline||6-month (primary)||||0.43
73944057|NCT05614089|147421050|SUPERIORITY|||||||0.008||||||Since this is one of two coprimary outcomes (this outcome and % time-in-range), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in serious hypoglycemia at baseline||12-month||||0.008
73958002|NCT03368001|147451531|OTHER|||||||0.217|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||Vocal Expressiveness Posttest.||||.217
73869429|NCT00536471|147283092|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.229
73944058|NCT05614089|147421051|SUPERIORITY|||||||0.71||||||Since this is one of two coprimary outcomes (this outcome and % time in serious hypoglycemia), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % TIR at baseline||6-month (primary)||||0.71
73975562|NCT02307682|147496020|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-11.7|0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||0.5|-11.7|
73869430|NCT00536471|147283092|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.044
73944059|NCT05614089|147421051|SUPERIORITY|||||||0.64||||||Since this is one of two coprimary outcomes (this outcome and % time in serious hypoglycemia), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % TIR at baseline||12-month||||0.64
73944060|NCT05614089|147421052|SUPERIORITY|||||||0.54|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in hypoglycemia at baseline||6-month||||0.54
73944061|NCT05614089|147421052|SUPERIORITY|||||||0.07|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in hypoglycemia at baseline||12-month||||0.07
73944062|NCT05614089|147421053|SUPERIORITY|||||||0.58|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time above range at baseline||6-month||||0.58
73944063|NCT05614089|147421053|SUPERIORITY|||||||0.21|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time above range at baseline||12-month||||0.21
73944064|NCT05614089|147421054|SUPERIORITY|||||||0.7|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and number of nocturnal events at baseline||6-month||||0.70
73944065|NCT05614089|147421054|SUPERIORITY|||||||0.02|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and number of nocturnal events at baseline||12-month||||0.02
73944066|NCT05614089|147421055|SUPERIORITY|||||||0.81|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and HbA1c at baseline||6-month||||0.81
73944067|NCT05614089|147421055|SUPERIORITY|||||||0.29|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and HbA1c at baseline||12-month||||0.29
73975563|NCT02307682|147496020|OTHER||Difference in proportions|-11.7|||||TWO_SIDED|95.0|-17.3|-6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-6.3|-17.3|
73944068|NCT05614089|147421056|SUPERIORITY|||||||0.98|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 6-month||||0.98
73944069|NCT05614089|147421056|SUPERIORITY|||||||0.61|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 12-month||||0.61
73944070|NCT05614089|147421057|SUPERIORITY|||||||0.83|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 6-month||||0.83
73944071|NCT05614089|147421057|SUPERIORITY|||||||0.09|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 12-month||||0.09
73944072|NCT05614089|147421058|SUPERIORITY|||||||0.95|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Symptoms score at baseline||6-month||||0.95
73944073|NCT05614089|147421058|SUPERIORITY|||||||0.73|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Symptoms score at baseline||12-month||||0.73
73944074|NCT05614089|147421059|SUPERIORITY|||||||0.81|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Management score at baseline||6-month||||0.81
73975564|NCT02307682|147496020|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.0|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.5|-4.0|
73869431|NCT00536471|147283092|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.092
73869432|NCT00536471|147283092|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
74031477|NCT01663740|147616361|SUPERIORITY_OR_OTHER||Mean Difference|-0.128|STANDARD_ERROR_OF_MEAN|0.3684||0.7323|TWO_SIDED|95.0|-0.888|0.633|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from EOT to end of FU|||0.633|-0.888|0.7323
74031478|NCT01663740|147616362|SUPERIORITY_OR_OTHER||Mean Difference|51.267|STANDARD_ERROR_OF_MEAN|36.6869||0.1756|TWO_SIDED|95.0|-24.626|127.159|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from EOT to end of FU|||127.159|-24.626|0.1756
74031479|NCT01663740|147616363|SUPERIORITY_OR_OTHER||Mean Difference|-10.195|STANDARD_ERROR_OF_MEAN|19.5745||0.6058|TWO_SIDED|95.0|-49.934|29.543|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to end of FU|||29.543|-49.934|0.6058
74031480|NCT01663740|147616364|SUPERIORITY_OR_OTHER||Mean Difference|-21.828|STANDARD_ERROR_OF_MEAN|9.1214||0.0222|TWO_SIDED|95.0|-40.346|-3.311|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to EOT|||-3.311|-40.346|0.0222
74031481|NCT01663740|147616364|SUPERIORITY_OR_OTHER||Mean Difference|-9.802|STANDARD_ERROR_OF_MEAN|8.3702||0.2495|TWO_SIDED|95.0|-26.795|7.19|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to end of FU|||7.190|-26.795|0.2495
74031482|NCT01663740|147616365|SUPERIORITY_OR_OTHER||Mean Difference|-11.683|STANDARD_ERROR_OF_MEAN|12.2576||0.3505|TWO_SIDED|95.0|-37.039|13.674|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from EOT to end of FU|||13.674|-37.039|0.3505
74031483|NCT01663740|147616366|SUPERIORITY_OR_OTHER||Mean Difference|-5.741|STANDARD_ERROR_OF_MEAN|6.7578||0.4021|TWO_SIDED|95.0|-19.524|8.042|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to EOT|||8.042|-19.524|0.4021
74031484|NCT01663740|147616366|SUPERIORITY_OR_OTHER||Mean Difference|-1.854|STANDARD_ERROR_OF_MEAN|5.1817||0.7229|TWO_SIDED|95.0|-12.423|8.714|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to end of FU|||8.714|-12.423|0.7229
73869433|NCT00536471|147283092|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.142
73944075|NCT05614089|147421059|SUPERIORITY|||||||0.44|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Management score at baseline||12-month||||0.44
73944076|NCT05614089|147421060|SUPERIORITY|||||||0.04|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and ITSQ at baseline||6-month||||0.04
73944077|NCT05614089|147421060|SUPERIORITY|||||||0.1|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and ITSQ at baseline||12-month||||0.10
73944078|NCT03371082|147421112|EQUIVALENCE|The limits of the lower and upper equivalence margin were -11.3 and 11.3, respectively.|Risk Difference (RD)|0.6|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|90.0|-5.4|6.5|||||The asymptotic standard error was planned and is reported above.|This is a two-arm study.||6.5|-5.4|
73944079|NCT01064297|147421124|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.2||||||95.0|1.6|3.1|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||3.1|1.6|
73944080|NCT01064297|147421124|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|4.2||||||95.0|1.4|11.0|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||11.0|1.4|
73944081|NCT01064297|147421124|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.4||||||95.0|1.7|3.3|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||3.3|1.7|
73944082|NCT01064297|147421125|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|10.7||||||95.0|6.4|17.0||||||||17.0|6.4|
73944083|NCT01064297|147421125|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|9.3||||||95.0|5.5|15.2|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||15.2|5.5|
73944084|NCT01064297|147421126|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.8||||||95.0|1.5|5.0||||||||5.0|1.5|
74031485|NCT01663740|147616367|SUPERIORITY_OR_OTHER||Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|7.7598||0.708|TWO_SIDED|95.0|-19.192|13.291|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from EOT to end of FU|||13.291|-19.192|0.7080
74031486|NCT01663740|147616368|SUPERIORITY_OR_OTHER||Mean Difference|-1.861|STANDARD_ERROR_OF_MEAN|1.6512||0.2673|TWO_SIDED|95.0|-5.213|1.491|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to EOT|||1.491|-5.213|0.2673
74031487|NCT01663740|147616368|SUPERIORITY_OR_OTHER||Mean Difference|-1.114|STANDARD_ERROR_OF_MEAN|1.6147||0.4949|TWO_SIDED|95.0|-4.392|2.164|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to end of FU|||2.164|-4.392|0.4949
74031488|NCT01663740|147616369|SUPERIORITY_OR_OTHER||Mean Difference|0.047|STANDARD_ERROR_OF_MEAN|1.51||0.9753|TWO_SIDED|95.0|-3.063|3.157|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from EOT to end of FU|||3.157|-3.063|0.9753
74031489|NCT01663740|147616370|SUPERIORITY_OR_OTHER||Mean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.6347||0.9053|TWO_SIDED|95.0|-1.214|1.366|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to EOT|||1.366|-1.214|0.9053
74031490|NCT01663740|147616370|SUPERIORITY_OR_OTHER||Mean Difference|-1.215|STANDARD_ERROR_OF_MEAN|0.4477||0.0104|TWO_SIDED|95.0|-2.125|-0.305|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to end of FU|||-0.305|-2.125|0.0104
74031491|NCT01663740|147616371|SUPERIORITY_OR_OTHER||Mean Difference|-1.065|STANDARD_ERROR_OF_MEAN|0.4057||0.0143|TWO_SIDED|95.0|-1.899|-0.231|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,\& pre-transplant dialysis duration as explanatory variables.|Change in LH level from EOT to end of FU|||-0.231|-1.899|0.0143
74031492|NCT01663740|147616372|SUPERIORITY_OR_OTHER||Mean Difference|2.541|STANDARD_ERROR_OF_MEAN|1.7274||0.1505|TWO_SIDED|95.0|-0.969|6.052|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to EOT|||6.052|-0.969|0.1505
74031493|NCT01663740|147616372|SUPERIORITY_OR_OTHER||Mean Difference|-0.983|STANDARD_ERROR_OF_MEAN|0.6739||0.1539|TWO_SIDED|95.0|-2.352|0.387|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to end of FU|||0.387|-2.352|0.1539
74031494|NCT01663740|147616373|SUPERIORITY_OR_OTHER||Mean Difference|-1.474|STANDARD_ERROR_OF_MEAN|0.8084||0.0798|TWO_SIDED|95.0|-3.136|0.188|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from EOT to end of FU|||0.188|-3.136|0.0798
74031495|NCT01663740|147616374|SUPERIORITY_OR_OTHER||Mean Difference|-0.104|STANDARD_ERROR_OF_MEAN|23.466||0.9965|TWO_SIDED|95.0|-47.792|47.585|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to EOT|||47.585|-47.792|0.9965
74031496|NCT01663740|147616374|SUPERIORITY_OR_OTHER||Mean Difference|15.272|STANDARD_ERROR_OF_MEAN|20.6031||0.4636|TWO_SIDED|95.0|-26.599|57.142|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to end of FU|||57.142|-26.599|0.4636
74031497|NCT01663740|147616375|SUPERIORITY_OR_OTHER||Mean Difference|8.74|STANDARD_ERROR_OF_MEAN|17.0805||0.6134|TWO_SIDED|95.0|-26.438|43.917|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from EOT to end of FU|||43.917|-26.438|0.6134
74031498|NCT01663740|147616376|SUPERIORITY_OR_OTHER||Mean Difference|8.142|STANDARD_ERROR_OF_MEAN|11.9301||0.5002|TWO_SIDED|95.0|-16.223|32.506|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to EOT|||32.506|-16.223|0.5002
74031499|NCT01663740|147616376|SUPERIORITY_OR_OTHER||Mean Difference|40.682|STANDARD_ERROR_OF_MEAN|17.6084||0.0279|TWO_SIDED|95.0|4.72|76.643|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to end of FU|||76.643|4.720|0.0279
74031500|NCT01663740|147616377|SUPERIORITY_OR_OTHER||Mean Difference|25.881|STANDARD_ERROR_OF_MEAN|22.1348||0.2548|TWO_SIDED|95.0|-20.024|71.786|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables|Change in inhibin B level from EOT to end of FU|||71.786|-20.024|0.2548
74031501|NCT01663740|147616378|SUPERIORITY_OR_OTHER||Difference in Percentage|14.3|||||TWO_SIDED|95.0|-19.3|45.3|||||Change in abnormal to abnormal sperm density from Baseline to EOT|||45.3|-19.3|
74031502|NCT01663740|147616378|SUPERIORITY_OR_OTHER||Difference in Percentage|5.0|||||TWO_SIDED|95.0|-34.3|43.3|||||Change in abnormal to abnormal sperm density from Baseline to end of FU|||43.3|-34.3|
73869434|NCT00536471|147283092|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.005
73869435|NCT00536471|147283093|SUPERIORITY_OR_OTHER|||||||0.921||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.921
73869436|NCT00536471|147283093|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.895
73869437|NCT00536471|147283093|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.789
73975565|NCT02307682|147496020|OTHER||Difference in proportions|-5.0|||||TWO_SIDED|95.0|-9.7|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||-0.3|-9.7|
73869438|NCT00536471|147283093|SUPERIORITY_OR_OTHER|||||||0.761||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.761
73975566|NCT02307682|147496020|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-11.4|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-0.1|-11.4|
73975567|NCT02307682|147496020|OTHER||Difference in proportions|-11.1|||||TWO_SIDED|95.0|-16.4|-6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-6.2|-16.4|
74031503|NCT01663740|147616378|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|95.0|-15.3|48.8|||||Change in normal to abnormal sperm density from Baseline to EOT|||48.8|-15.3|
74031504|NCT01663740|147616379|SUPERIORITY_OR_OTHER||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-34.5|42.5|||||Change in abnormal to abnormal sperm density from EOT to end of FU|||42.5|-34.5|
73869439|NCT00536471|147283093|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.519
73869440|NCT00536471|147283093|SUPERIORITY_OR_OTHER|||||||0.755||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.755
73869441|NCT00536471|147283093|SUPERIORITY_OR_OTHER|||||||0.829||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.829
73869442|NCT00536471|147283093|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
73869443|NCT00536471|147283094|SUPERIORITY_OR_OTHER|||||||0.753||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.753
73869444|NCT00536471|147283094|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.036
73869445|NCT00536471|147283096|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.342
73869446|NCT00536471|147283096|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.111
73869447|NCT00536471|147283098|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.302
73869448|NCT00536471|147283098|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.029
73869449|NCT00536471|147283098|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.325
73869450|NCT00536471|147283098|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.423
73869451|NCT00536471|147283099|SUPERIORITY_OR_OTHER|||||||0.731||95.0||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.731
73975568|NCT02307682|147496021|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-7.9|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-7.9|
74031505|NCT01663740|147616380|SUPERIORITY_OR_OTHER||Difference in Percentage|1.3|||||TWO_SIDED|95.0|-31.3|33.7|||||Improvement from Baseline to EOT|||33.7|-31.3|
74031506|NCT01663740|147616380|SUPERIORITY_OR_OTHER||Difference in Percentage|6.7|||||TWO_SIDED|95.0|-31.1|44.4|||||Improvement from Baseline to end of FU|||44.4|-31.1|
74031507|NCT01663740|147616381|SUPERIORITY_OR_OTHER||Difference in Percentage|-11.8|||||TWO_SIDED|95.0|-50.0|29.3|||||Improvement from EOT to end of FU|||29.3|-50.0|
74031508|NCT01663740|147616382|SUPERIORITY_OR_OTHER||Difference in Percentage|-31.0|||||TWO_SIDED|95.0|-59.7|2.7|||||Improvement from Baseline to EOT|||2.7|-59.7|
73869452|NCT00536471|147283099|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.022
73869453|NCT00536471|147283099|SUPERIORITY_OR_OTHER|||||||0.948||95.0||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.948
73944085|NCT01064297|147421126|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.8||||||95.0|1.6|4.9|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||4.9|1.6|
73944086|NCT04506775|147421133|NON_INFERIORITY|As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.|Mean Error|0.9|||||TWO_SIDED|||||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.||||||||
73944087|NCT04506775|147421134|NON_INFERIORITY|As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|Mean Error|0.19|||||TWO_SIDED|||||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|||
73944088|NCT04058353|147421148|SUPERIORITY||Least Squares (LS) Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.2|4.7|||Mixed-effects model for repeated measure|||||4.7|2.2|<0.0001
73944089|NCT04058353|147421149|SUPERIORITY||LS Mean Difference|-23.1|||<|0.0001|TWO_SIDED|95.0|-26.1|-20.1|||Mixed-effects model for repeated measure|||||-20.1|-26.1|<0.0001
73944090|NCT04058353|147421151|SUPERIORITY||LS Mean Difference|8.7|||<|0.0001|TWO_SIDED|95.0|5.3|12.1|||Mixed-effects model for repeated measure|||||12.1|5.3|<0.0001
73975569|NCT02307682|147496021|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.1|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||7.4|-4.1|
73944091|NCT00279201|147421159|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|P-value from ANCOVA, baseline value as covariate. Response = Treatment + Baseline + Country + thiazolidinedione (TZD) use + Sulfonylurea (sulfo) use.||||||0.005
73944092|NCT00279201|147421160|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Log Rank|Stratified by country, thiazolidinedione (TZD) use, sulfo use.||||||0.040
73944093|NCT00279201|147421161|SUPERIORITY_OR_OTHER|||||||0.271||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
73944094|NCT00279201|147421161|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
73975570|NCT02307682|147496021|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-10.0|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.3|-10.0|
73975571|NCT02307682|147496021|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-7.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||4.5|-7.7|
73975572|NCT02307682|147496021|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-7.6|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.3|-7.6|
74031509|NCT01663740|147616382|SUPERIORITY_OR_OTHER||Difference in Percentage|10.0|||||TWO_SIDED|95.0|-29.7|47.7|||||Improvement from Baseline to end of FU|||47.7|-29.7|
74031510|NCT01663740|147616383|SUPERIORITY_OR_OTHER||Difference in Percentage|-9.9|||||TWO_SIDED|95.0|-47.2|27.9|||||Improvement from EOT to end of FU|||27.9|-47.2|
73869454|NCT00536471|147283099|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.022
73869455|NCT00536471|147283099|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.950
73869456|NCT00536471|147283099|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.442
73869457|NCT00536471|147283099|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.218
73944095|NCT00279201|147421162|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||0.005
73944096|NCT00279201|147421163|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for \<=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.002
73944097|NCT00279201|147421163|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for \<7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||<0.001
73944098|NCT00279201|147421163|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value is for \<=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.174
73944099|NCT00279201|147421164|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.416
73944100|NCT00279201|147421164|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
73975573|NCT02307682|147496021|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.4|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.8|-5.4|
73944101|NCT00279201|147421164|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.003
73944102|NCT00279201|147421164|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.005
73944103|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.179
73944104|NCT00279201|147421165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
73944105|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||P-value is for Baseline AM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.700
73944106|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for AM 2-hour postprandial blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.016
73975574|NCT02307682|147496021|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.3|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.6|-8.3|
73869458|NCT00536471|147283099|SUPERIORITY_OR_OTHER|||||||0.648||95.0||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.648
73869459|NCT00536471|147283100|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.653
73944107|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.971||95.0||||P-value is for Baseline midday premeal BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.971
73944108|NCT00279201|147421165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Midday premeal blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
73944109|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||P-value is for Baseline midday 2-hour postprandial BG|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.759
73944110|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-value Midday 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.514
73944111|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.321||95.0||||P-value is for Baseline evening pre-meal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.321
73944112|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value for Evening pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.161
73975575|NCT02307682|147496021|OTHER||Difference in proportions|-4.3|||||TWO_SIDED|95.0|-10.0|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||1.9|-10.0|
73869460|NCT00536471|147283100|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.016
73869461|NCT00536471|147283100|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.665
73869462|NCT00536471|147283100|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.127
73944113|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||P-value is for Baseline evening 2hour postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.297
73944114|NCT00279201|147421165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value Evening 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
73944115|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Baseline 3 AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.199
73944116|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.693||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.693
73944117|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for Baseline AM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.021
73944118|NCT00279201|147421165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
73944119|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-value is for Baseline midday 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.567
73944120|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for Midday 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.005
73944121|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.994||95.0||||P-value is for Baseline PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.994
73944122|NCT00279201|147421165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
73944123|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.436
73944124|NCT00279201|147421165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Mean of all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
73944125|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.628||95.0||||P-value is for Baseline mean all 2hour PP BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.628
73869463|NCT00536471|147283101|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.475
73869464|NCT00536471|147283101|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.561
73869465|NCT00536471|147283101|SUPERIORITY_OR_OTHER|||||||0.213||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.213
73869466|NCT00536471|147283101|SUPERIORITY_OR_OTHER|||||||0.536||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.536
73869467|NCT00536471|147283101|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.158
73869468|NCT00536471|147283101|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.759
73869469|NCT00536471|147283101|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.190
73869470|NCT00536471|147283101|SUPERIORITY_OR_OTHER|||||||0.852||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.852
73869471|NCT00536471|147283102|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.032
73869472|NCT00536471|147283102|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||<0.001
73869473|NCT00536471|147283102|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.705
73869474|NCT00536471|147283102|SUPERIORITY_OR_OTHER|||||||0.388||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.388
73944126|NCT00279201|147421165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Mean of all 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
73944127|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-value is for Baseline AM/PM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.677
73944128|NCT00279201|147421165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM/PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
73944129|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value is for Baseline mean all premeal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.364
73869475|NCT00536471|147283103|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.161
73869476|NCT00536471|147283103|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.198
73869477|NCT00536471|147283103|SUPERIORITY_OR_OTHER|||||||0.982||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.982
73869478|NCT00536471|147283103|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.407
73869479|NCT00536471|147283104|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.001
73869480|NCT00536471|147283104|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.006
73869481|NCT00536471|147283104|SUPERIORITY_OR_OTHER|||||||0.231||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.231
73944130|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is for Mean of all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.055
73944131|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for Baseline AM/PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.165
73944132|NCT00279201|147421165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM/PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
73944133|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value is for Baseline mean of all BG values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.464
73975576|NCT02307682|147496021|OTHER||Difference in proportions|10.6|||||TWO_SIDED|95.0|5.0|16.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||16.2|5.0|
73975577|NCT02307682|147496021|OTHER||Difference in proportions|10.0|||||TWO_SIDED|95.0|4.7|15.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||15.4|4.7|
73975578|NCT02307682|147496021|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.8|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||1.7|-9.8|
73975579|NCT02307682|147496021|OTHER||Difference in proportions|-9.0|||||TWO_SIDED|95.0|-14.9|-3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.0|-14.9|
73975580|NCT02307682|147496021|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-2.1|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.4|-2.1|
73975581|NCT02307682|147496021|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.3|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.1|-6.3|
73975582|NCT02307682|147496021|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-5.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||6.1|-5.8|
73975583|NCT02307682|147496021|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.5|-8.4|
73975584|NCT02307682|147496021|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-6.4|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.4|-6.4|
73975585|NCT02307682|147496021|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.8|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.0|-7.8|
73975586|NCT02307682|147496021|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.6|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.7|-9.6|
73975587|NCT02307682|147496021|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-10.2|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.9|-10.2|
73975588|NCT02307682|147496021|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-1.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||9.9|-1.0|
74031511|NCT04400318|147616384|SUPERIORITY||Odds Ratio (OR)|9.81|||<|0.001|TWO_SIDED|95.0|3.13|30.82|||Cochran-Mantel-Haenszel|||Odds Ratio, 95% confidence interval (CI) of the odds ratio and p-value between the dupilumab and placebo group based on the Cochran-Mantel-Haenszel (CMH) test adjusted by ICS dose level (medium/high) and region (Eastern Europe/ROW).||30.82|3.13|<0.001
73869482|NCT00536471|147283104|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.040
73975589|NCT02307682|147496021|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.3|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.5|-3.3|
73975590|NCT02307682|147496021|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.2|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.1|-6.2|
74031512|NCT04400318|147616385|SUPERIORITY||Least square mean difference|21.76|STANDARD_ERROR_OF_MEAN|14.022||0.138|TWO_SIDED|95.0|-7.73|51.25|||MMRM|||The mixed model for repeated measures (MMRM) included study intervention, baseline value, region, ICS dose level, visits, study intervention by visit interaction, and baseline by visit interaction terms all as fixed effects. Region, ICS, study intervention and visits were considered as categorical parameters.||51.25|-7.73|0.138
73944134|NCT00279201|147421165|SUPERIORITY_OR_OTHER|||||||0.305||95.0||||P-value is for Mean of all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.305
73869483|NCT00536471|147283105|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.914
73944135|NCT00279201|147421166|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|ANCOVA model with treatment, baseline, country, TZD use, and sulfo use.||||||0.003
73944136|NCT00279201|147421167|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 6.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944137|NCT00279201|147421167|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 12.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944138|NCT00279201|147421167|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 18|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944139|NCT00279201|147421167|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944140|NCT00279201|147421167|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944141|NCT00279201|147421168|SUPERIORITY_OR_OTHER|||||||0.497||95.0||||P-value for Actual weight at baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.497
73944142|NCT00279201|147421168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
73944143|NCT00279201|147421168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Actual weight at Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
73944144|NCT00279201|147421168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 18.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
73944145|NCT00279201|147421168|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
73944146|NCT00279201|147421168|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Actual weight at Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.0001
73944147|NCT00279201|147421169|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for Hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.016
73944148|NCT00279201|147421169|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value is for Overall hypoglycemic episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.037
73944149|NCT00279201|147421169|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for Nocturnal hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.834
73944150|NCT00279201|147421169|SUPERIORITY_OR_OTHER|||||||0.585||95.0||||P-value is for Nocturnal hypoglycemic episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.585
73944151|NCT00279201|147421169|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value is for Severe hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.241
73944152|NCT00279201|147421169|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||P-value is for Severe hypoglycemic episodes overall. Initiation phase and maintenance phase are included.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.080
73944153|NCT00279201|147421170|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.009
73944154|NCT00279201|147421170|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.420
73944155|NCT00279201|147421170|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.165
73944156|NCT00279201|147421170|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.167
73944157|NCT00279201|147421170|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.006
73944158|NCT00279201|147421170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||<0.001
73944159|NCT00279201|147421171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
73944160|NCT00279201|147421171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
73944161|NCT00279201|147421171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
73944162|NCT00279201|147421171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
73944163|NCT00279201|147421171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
73944164|NCT00279201|147421171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
73869484|NCT00536471|147283105|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
73869485|NCT00536471|147283105|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.296
73869486|NCT00536471|147283105|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.034
73869487|NCT00536471|147283105|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.874
73869488|NCT00536471|147283105|SUPERIORITY_OR_OTHER|||||||0.614||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.614
73869489|NCT00536471|147283105|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.146
73869490|NCT00536471|147283105|SUPERIORITY_OR_OTHER|||||||0.877||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.877
73869491|NCT00536471|147283106|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.012
73869492|NCT00536471|147283106|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.045
73869493|NCT00536471|147283106|SUPERIORITY_OR_OTHER|||||||0.701||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.701
73869494|NCT00536471|147283106|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.081
73869495|NCT00536471|147283107|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.013
73869496|NCT00536471|147283107|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.672
73869497|NCT00536471|147283107|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.874
73944165|NCT00279201|147421171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
73944166|NCT00279201|147421171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
73944167|NCT00279201|147421171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
73944168|NCT00279201|147421171|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is for Week 18.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||0.001
73944169|NCT00279201|147421171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
73944170|NCT00279201|147421171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
73944171|NCT00279201|147421172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
73944172|NCT00279201|147421173|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.||||||<0.001
73944173|NCT00279201|147421174|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
73944174|NCT00279201|147421175|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use and Sulfo use in model.||||||<0.001
73944175|NCT00279201|147421176|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||<0.001
73944176|NCT00279201|147421177|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
73944177|NCT00279201|147421178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Pre Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
73944178|NCT00279201|147421178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Post Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
73944179|NCT00279201|147421178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Average of All Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
73944180|NCT00279201|147421178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Fasting Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
73944181|NCT00279201|147421179|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Sulfonylurea/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||<0.001
73944182|NCT00279201|147421179|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for TZD/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||<0.001
73944183|NCT00279201|147421179|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.969
73944184|NCT00279201|147421179|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value is for Patients with 3 drugs (Sulfonylurea/TZD/Metformin).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.225
73944185|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value is for Week 0.|ANOVA|ANCOVA used with treatment, country, TZD use, and sulfo use in the model.||||||0.204
73944186|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Week 12.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.004
73944187|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value is for Week 24.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.657
73944188|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value is for Week 36.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.595
73944189|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||P-value for Week 48.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.142
73944190|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.551||95.0||||P-value for Week 60.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.551
73944191|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-value is for Week 72.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.779
73944192|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||P-value is for Week 84.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.175
73944193|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Week 96.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.018
73944194|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for Week 108.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.047
73944195|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for Week 120.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.027
73944196|NCT00279201|147421180|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value is for Endpoint.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.017
73944197|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.218
73944198|NCT00279201|147421181|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
73944199|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-value is for Baseline AM 2-hour (hr) postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.897
73944200|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||P-value is for Endpoint AM 2-hour postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.138
73944201|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.867||95.0||||P-value is for Baseline midday premeal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.867
73944202|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value is for Endpoint midday premeal blood.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.031
73944203|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-value is for Baseline midday 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.792
73944204|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||P-value is for Endpoint midday 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.510
73944205|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.535||95.0||||P-value is for Baseline PM pre-meal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.535
73944206|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||P-value is for Endpoint PM pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.517
73944207|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.869||95.0||||P-value is for Baseline PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.869
73944208|NCT00279201|147421181|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
73944209|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value is for Baseline 3AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.164
73944210|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||P-value is for Endpoint 3AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.234
73944211|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||P-value is for Baseline AM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.175
73944212|NCT00279201|147421181|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint AM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
73944213|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||P-value is for Baseline midday 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.589
73944214|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Endpoint midday 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.161
73944215|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.674||95.0||||P-value is for Baseline PM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.674
73944216|NCT00279201|147421181|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint PM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
73869498|NCT00536471|147283107|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.390
73975591|NCT02307682|147496021|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.4|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.5|-6.4|
73975592|NCT02307682|147496021|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-2.2|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.7|-2.2|
73975593|NCT02307682|147496021|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.2|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||7.4|-3.2|
73975594|NCT02307682|147496021|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.5|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||8.1|-3.5|
73975595|NCT02307682|147496021|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-5.8|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.8|-5.8|
73975596|NCT02307682|147496021|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-6.6|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.8|-6.6|
73975597|NCT02307682|147496021|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.8|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.1|-5.8|
73975598|NCT02307682|147496021|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.1|-6.4|
73975599|NCT02307682|147496021|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-8.7|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||2.6|-8.7|
73975600|NCT02307682|147496021|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|0.3|10.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||10.7|0.3|
73975601|NCT02307682|147496021|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-3.2|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||7.2|-3.2|
74031513|NCT04400318|147616386|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only 2 secondary outcome measures (#4 and #5) were included in this procedure.|Least square mean difference|-4.92|STANDARD_ERROR_OF_MEAN|0.798|<|0.001|TWO_SIDED|95.0|-6.5|-3.34|||MMRM|||MMRM model included study intervention (dupilumab, placebo), baseline value of global lung UCSF mucus scoring, region (Eastern Europe/ROW), ICS dose level (medium/high), visit (up to Week 24), study intervention-by-visit interaction and baseline-by-visit interaction as covariates.||-3.34|-6.50|<0.001
74031514|NCT04400318|147616387|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only 2 secondary outcome measures (#4 and #5) were included in this procedure.|Least square mean difference|-53.45|STANDARD_ERROR_OF_MEAN|39.562||0.18|TWO_SIDED|95.0|-132.09|25.19|||MMRM|||MMRM model included study intervention (dupilumab, placebo), baseline value of trimmed distal \[s\]iRaw at TLC, region (Eastern Europe/ROW), ICS dose level (medium/high), visit (up to Week 24), study intervention-by-visit interaction, and baseline-by-visit interaction as covariates.||25.19|-132.09|0.180
74031515|NCT00747617|147616397|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
73869499|NCT00536471|147283112|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Bilirubin - 12 Week Change.|ANOVA|||||||0.046
73869500|NCT00536471|147283112|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value for Creatinine - 12 Week Change.|ANOVA|||||||0.031
73869501|NCT00536471|147283112|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Uric Acid - 12 Week Change.|ANOVA|||||||0.003
73869502|NCT00536471|147283112|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value for Bilirubin - 9 Month Change.|ANOVA|||||||0.033
73869503|NCT00536471|147283112|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Uric Acid - 9 Month Change.|ANOVA|||||||0.013
73869504|NCT00536471|147283113|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Hematocrit - 12 Week Change.|ANOVA|||||||0.037
73869505|NCT00536471|147283113|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Hematocrit - 9 Month Change.|ANOVA|||||||0.029
73869506|NCT00536471|147283114|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for MCV - 12 Week Change.|ANOVA|||||||0.013
73869507|NCT00536471|147283114|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for MCV - 9 Month Change.|ANOVA|||||||0.014
73869508|NCT00536471|147283115|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Chloride - 12 Week Change.|ANOVA|||||||0.022
73869509|NCT00536471|147283115|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||P-value for Urea Nitrogen - 12 Week Change.|ANOVA|||||||0.044
73869510|NCT00536471|147283115|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Chloride - 9 Month Change.|ANOVA|||||||0.004
73869511|NCT00536471|147283115|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P-value for Cholesterol - 9 Month Change.|ANOVA|||||||0.045
73944217|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.201
73944218|NCT00279201|147421181|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint mean all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
73944219|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.956||95.0||||P-value is for Baseline mean of all 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.956
73944220|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value is for Endpoint mean of all 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.019
73944221|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value is for Baseline mean all premeal.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.445
73944222|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for Endpoint mean all premeal.|ANOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.371
73944223|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value is for Baseline combined AM/PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.848
73944224|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Endpoint combined AM/PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.002
73944225|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value is for Baseline AM/PM 2hr postprandial excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.281
73944226|NCT00279201|147421181|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint AM/PM 2hr postprandial excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
73975602|NCT02307682|147496021|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.1|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.7|-6.1|
73975603|NCT02307682|147496021|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.0|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||1.9|-9.0|
73869512|NCT00536471|147283115|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||P-value for Sodium - 9 Month Change.|ANOVA|||||||0.043
73869513|NCT00536471|147283116|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for 12 Week Change.|ANOVA|||||||0.017
73869514|NCT00536471|147283116|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for 9 Month Change.|ANOVA|||||||0.003
73944227|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||P-value is for Baseline mean all blood glucose values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.588
73944228|NCT00279201|147421181|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||P-value is for Endpoint mean all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.217
73944229|NCT00279201|147421182|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.300
73944230|NCT00279201|147421183|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value for \<=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.134
73944231|NCT00279201|147421183|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for \<7.0%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.089
73944232|NCT00279201|147421183|SUPERIORITY_OR_OTHER|||||||0.235||95.0||||P-value is for \<=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.235
73944233|NCT00279201|147421184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944234|NCT00279201|147421184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 36.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944235|NCT00279201|147421184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 48.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944236|NCT00279201|147421184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 60.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73975604|NCT02307682|147496021|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-1.9|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.1|-1.9|
73975605|NCT02307682|147496021|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-3.9|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.4|-3.9|
73975606|NCT02307682|147496021|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.7|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.6|-4.7|
73975607|NCT02307682|147496021|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.2|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.1|-5.2|
73975608|NCT02307682|147496021|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.3|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||7.3|-3.3|
73975609|NCT02307682|147496021|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-5.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.8|-5.7|
73975610|NCT02307682|147496021|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-1.7|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||9.7|-1.7|
73975611|NCT02307682|147496021|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-5.3|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||5.6|-5.3|
73975612|NCT02307682|147496021|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-1.3|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.9|-1.3|
73975613|NCT02307682|147496021|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.3|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.0|-4.3|
73975614|NCT02307682|147496021|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||5.2|-6.4|
73869515|NCT00536471|147283117|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANOVA|||||||0.033
73975615|NCT02307682|147496021|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-10.8|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.9|-10.8|
73975616|NCT02307682|147496022|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-7.7|
73869516|NCT00536471|147283118|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
73975617|NCT02307682|147496022|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-11.4|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.4|-11.4|
73975618|NCT02307682|147496022|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.3|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.2|-9.3|
73975619|NCT02307682|147496022|OTHER||Difference in proportions|-4.4|||||TWO_SIDED|95.0|-9.8|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.2|-9.8|
73869517|NCT00536471|147283119|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.041
73869518|NCT00536471|147283119|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||P-value for Potassium - Low.|Fisher Exact|||||||0.048
73975620|NCT02307682|147496022|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-11.5|-1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.5|-11.5|
73975621|NCT02307682|147496022|OTHER||Difference in proportions|-7.6|||||TWO_SIDED|95.0|-12.8|-2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.3|-12.8|
73975622|NCT02307682|147496022|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-11.8|-1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-1.1|-11.8|
73975623|NCT02307682|147496022|OTHER||Difference in proportions|-8.6|||||TWO_SIDED|95.0|-14.4|-2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.9|-14.4|
73975624|NCT02307682|147496022|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-2.8|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||8.3|-2.8|
73975625|NCT02307682|147496022|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.4|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.5|-3.4|
73975626|NCT02307682|147496022|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-9.7|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||0.9|-9.7|
73975627|NCT02307682|147496022|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-12.3|-1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-1.3|-12.3|
73975628|NCT02307682|147496022|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.2|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.2|-4.2|
73975629|NCT02307682|147496022|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-8.4|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||1.7|-8.4|
73975630|NCT02307682|147496022|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-6.2|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.2|-6.2|
73975631|NCT02307682|147496022|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-7.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.4|-7.5|
73975632|NCT02307682|147496022|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-9.5|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||0.7|-9.5|
73975633|NCT02307682|147496022|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.6|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-0.6|-10.6|
74031516|NCT02279524|147616399|SUPERIORITY||Difference in least square means|-3.09||||0.0655|TWO_SIDED|1.6|||||Mixed Models Analysis||||Post-Hoc Responder Analysis - was also carried out. See Post-Hoc analysis|||0.0655
73944237|NCT00279201|147421184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 72.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944238|NCT00279201|147421184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 84.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944239|NCT00279201|147421184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 96.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944240|NCT00279201|147421184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 108|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944241|NCT00279201|147421184|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Change from baseline at Week 120.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||0.002
73944242|NCT00279201|147421184|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
73944243|NCT00279201|147421185|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.128
73944244|NCT00279201|147421185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
73944245|NCT00279201|147421185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 36.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
73944246|NCT00279201|147421185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 48.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
73944247|NCT00279201|147421185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 60.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
73944248|NCT00279201|147421185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 72.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
73944249|NCT00279201|147421185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 84.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
73944250|NCT00279201|147421185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 96.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
73944251|NCT00279201|147421185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 108.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
73869519|NCT00536471|147283120|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.012
73944252|NCT00279201|147421185|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Week 120.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||0.002
73869520|NCT00536471|147283120|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value for Potassium - Low.|Fisher Exact|||||||0.049
73944253|NCT00279201|147421185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
73944254|NCT00279201|147421186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
73944255|NCT00279201|147421186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 36.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
73944256|NCT00279201|147421186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 48.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
73944257|NCT00279201|147421186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 60.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
73944258|NCT00279201|147421186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 72.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
73944259|NCT00279201|147421186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 84.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
73944260|NCT00279201|147421186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 96.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
73944261|NCT00279201|147421186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 108.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
73944262|NCT00279201|147421186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 120.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
73944263|NCT00279201|147421186|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
73944264|NCT00279201|147421187|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||P-value is for Overall hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.370
73944265|NCT00279201|147421187|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-Value for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.006
73944266|NCT00279201|147421187|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.397
73944267|NCT00279201|147421187|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.253
73944268|NCT00279201|147421187|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||P-value is for Severe episodes endpoint.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.893
73944269|NCT00279201|147421187|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.391
73944270|NCT00279201|147421188|SUPERIORITY_OR_OTHER|||||||0.497||95.0||||P-value for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.497
73944271|NCT00279201|147421188|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.071
73944272|NCT00279201|147421188|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.065
74031517|NCT02279524|147616399|SUPERIORITY||Difference in least square means|-3.32||||0.045|TWO_SIDED|1.6|||||Mixed Models Analysis||||Post-Hoc Responder Analysis - was also carried out. See Post-Hoc analysis|||0.0450
74031518|NCT02279524|147616400|SUPERIORITY||Odds Ratio (OR)|4.74||||0.0514|TWO_SIDED|95.0|0.99|22.66|||Regression, Logistic|The method used was a Baseline Adjusted Logistic Regression||||22.66|0.99|0.0514
74031519|NCT02279524|147616400|SUPERIORITY||Odds Ratio (OR)|1.79||||0.4955|TWO_SIDED|95.0|0.33|9.61|||Regression, Logistic|||||9.61|0.33|0.4955
74031520|NCT02279524|147616401|SUPERIORITY||Odds Ratio (OR)|1.88||||0.211|TWO_SIDED|95.0|0.7|5.04|||Regression, Logistic|||||5.04|0.70|0.2110
74031521|NCT02279524|147616401|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8425|TWO_SIDED|95.0|0.4|3.05|||Regression, Logistic|||||3.05|0.40|0.8425
74031522|NCT02279524|147616402|SUPERIORITY||Difference in least square means|-29.1|STANDARD_ERROR_OF_MEAN|6.4|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.0001
74031523|NCT02279524|147616402|SUPERIORITY||Difference in least square means|-23.8|STANDARD_ERROR_OF_MEAN|6.3||0.0002|TWO_SIDED||||||Mixed Models Analysis|||||||0.0002
74031524|NCT02279524|147616403|SUPERIORITY||Difference in least square means|-0.447||||0.0008|TWO_SIDED|95.0|-0.7063|-0.1877|||Mixed Models Analysis|||||-0.1877|-0.7063|0.0008
73944273|NCT00279201|147421188|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.021
74031525|NCT02279524|147616403|SUPERIORITY||Difference in least square means|-0.362||||0.0061|TWO_SIDED|95.0|-0.6196|-0.1043|||Mixed Models Analysis|||||-0.1043|-0.6196|0.0061
74031526|NCT02279524|147616404|SUPERIORITY||Difference in least square means|-17.5|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
73869521|NCT00536471|147283121|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.012
74031527|NCT02279524|147616404|SUPERIORITY||Difference in least square means|-13.9|STANDARD_ERROR_OF_MEAN|4.2||0.0011|TWO_SIDED||||||Mixed Models Analysis|||||||0.0011
74031528|NCT02279524|147616405|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0279|TWO_SIDED|95.0|1.11|6.88|||Mixed Models Analysis|||||6.88|1.11|0.0279
74031529|NCT02279524|147616405|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0878|TWO_SIDED|95.0|0.89|5.46|||Regression, Logistic|||||5.46|0.89|0.0878
74031530|NCT02279524|147616406|SUPERIORITY||Odds Ratio (OR)|0.14||||0.1008|TWO_SIDED|95.0|0.01|1.46|||Regression, Logistic||This analysis is limited by low number of events, and the duration of the study.|||1.46|0.01|0.1008
74031531|NCT02279524|147616406|SUPERIORITY||Odds Ratio (OR)|0.63||||0.5693|TWO_SIDED|95.0|0.13|3.05|||Regression, Logistic||This analysis is limited by low number of events, and the duration of the study.|||3.05|0.13|0.5693
74031532|NCT00738543|147616407|NON_INFERIORITY_OR_EQUIVALENCE|A minimal sample of 20 volunteers was calculated to to find a difference of 200 CFU/mL, with a power of 80% and bilateral error of 5%.|||||<|0.05||||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the three medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used.||||<0.05
74031533|NCT00738543|147616409|NON_INFERIORITY_OR_EQUIVALENCE|The minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL.|||||<|0.05||95.0||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the 3 medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used. The alpha level for significance was established at 5%. A minimal sample of 20 volunteers was calculated for a power of 80%, and bilateral error of 5%.||||<0.05
74031534|NCT00883558|147616458|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of INSULIN-PH20 NP to insulin lispro was supported if the upper limit of the one-sided 95% confidence interval for the difference in blood glucose between the treatments did not exceed 21.6 mg/dL.|LS Mean Difference|3.06||||0.3217|ONE_SIDED|95.0||14.11|||Mixed Models Analysis|Adjustments included treatment, phase, and treatment sequence as fixed effects and participant within treatment sequence as a random effect.||A total of at least 40 participants were to be enrolled in the study, and 30 participants were expected to complete both treatment cycles. Assuming a standard deviation for blood glucose of 45 milligrams per deciliter (mg/dL) and a true difference between the treatments of 0 mg/dL, the study had approximately 80% power to show that INSULIN-PH20 NP was non-inferior to insulin lispro with respect to the overall two-hour postprandial blood glucose excursion.||14.11||0.3217
74031535|NCT00623467|147616529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|STANDARD_DEVIATION|0.86|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
73869522|NCT00536471|147283121|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Hemoglobin - Low.|Fisher Exact|||||||0.038
73944274|NCT00279201|147421188|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.200
74031536|NCT00623467|147616529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_DEVIATION|0.74|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74031537|NCT00623467|147616529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53|STANDARD_DEVIATION|0.54|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74031538|NCT00623467|147616530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|STANDARD_DEVIATION|0.8|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
74031539|NCT00623467|147616530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_DEVIATION|0.94|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74031540|NCT00623467|147616530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|STANDARD_DEVIATION|0.74|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74031541|NCT00623467|147616531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93|STANDARD_DEVIATION|0.82|<|0.0001||||||for contrast enhancement|paired t-test|||||||<0.0001
74031542|NCT00623467|147616531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.12|STANDARD_DEVIATION|0.74|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74031543|NCT00623467|147616531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.57|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74031544|NCT00623467|147616532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|STANDARD_DEVIATION|0.77|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
73944275|NCT00279201|147421188|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.208
73944276|NCT00279201|147421189|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, TZD use and sulfo use.||||||0.004
73975634|NCT02307682|147496022|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-10.2|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.3|-10.2|
73975635|NCT02307682|147496022|OTHER||Difference in proportions|-6.3|||||TWO_SIDED|95.0|-12.2|-0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.8|-12.2|
73975636|NCT02307682|147496022|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-6.6|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.3|-6.6|
73975637|NCT02307682|147496022|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-10.0|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||0.1|-10.0|
73975638|NCT02307682|147496022|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.4|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||1.4|-9.4|
73975639|NCT02307682|147496022|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-13.6|-2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-2.7|-13.6|
74031545|NCT00623467|147616532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|0.71|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
73944277|NCT00279201|147421190|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value is for Baseline at Week 0.|ANOVA|ANOVA used with treatment, country, TZD use and Sulfo use in the model.||||||0.204
73975640|NCT02307682|147496022|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-5.1|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.5|-5.1|
73975641|NCT02307682|147496022|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.2|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||2.8|-6.2|
73975642|NCT02307682|147496022|OTHER||Difference in proportions|-4.2|||||TWO_SIDED|95.0|-9.4|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||1.2|-9.4|
73975643|NCT02307682|147496022|OTHER||Difference in proportions|-6.2|||||TWO_SIDED|95.0|-11.5|-0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-0.8|-11.5|
73975644|NCT02307682|147496022|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.3|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.0|-7.3|
73975645|NCT02307682|147496022|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-7.9|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||2.1|-7.9|
73975646|NCT02307682|147496022|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-10.5|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||0.7|-10.5|
74031546|NCT00623467|147616532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|0.53|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74031547|NCT00623467|147616533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|5.31|||||||||||for BR1|||||
74031548|NCT00623467|147616533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_DEVIATION|8.77|||||||||||for BR2|||||
73944278|NCT00279201|147421190|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-Value is for Change from baseline to endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.||||||0.017
73944279|NCT00279201|147421190|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for Change Week 24 to Week 120 endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.||||||0.020
73944280|NCT00279201|147421191|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.036
73944281|NCT00279201|147421192|SUPERIORITY_OR_OTHER|||||||0.708||95.0|||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.708
73944282|NCT00279201|147421193|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.||||||0.028
73944283|NCT00279201|147421194|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Cochran-Mantel-Haenszel|Stratified by country, TZD use, and sulfo use.||||||0.738
73944284|NCT00279201|147421195|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||<0.001
73975647|NCT02307682|147496022|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-12.5|-1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-1.8|-12.5|
73975648|NCT02307682|147496022|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.0|-6.0|
73975649|NCT02307682|147496022|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-6.3|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.9|-6.3|
73975650|NCT02307682|147496022|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.1|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-0.4|-10.1|
73975651|NCT02307682|147496022|OTHER||Difference in proportions|-7.3|||||TWO_SIDED|95.0|-12.2|-2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-2.3|-12.2|
73975652|NCT02307682|147496022|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.2|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.3|-5.2|
74031549|NCT00623467|147616533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_DEVIATION|4.2|||||||||||for BR3|||||
74031550|NCT00623467|147616533|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|3.53|||TWO_SIDED|95.0|-0.07|0.704|||95% confidence interval for paired means||confidence interval provided for average reader, lower limit is compared to noninferiority margin|||0.704|-0.070|
74031551|NCT00623467|147616534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_DEVIATION|0.68|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
73975653|NCT02307682|147496022|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-5.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||3.5|-5.8|
74031552|NCT00623467|147616534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|0.65|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
73944285|NCT00279201|147421196|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.043
74031553|NCT00623467|147616535|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|1.6||||95.0|0.03|0.381|||||lower limit of the confidence interval is compared to the noninferiority margin|||0.381|0.030|
74031554|NCT00623467|147616536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|STANDARD_DEVIATION|1.47|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
74031555|NCT00623467|147616536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|STANDARD_DEVIATION|1.34|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74031556|NCT00623467|147616536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_DEVIATION|1.03|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74031557|NCT00623467|147616537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|STANDARD_DEVIATION|1.38|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
74031558|NCT00623467|147616537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_DEVIATION|1.6|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74031559|NCT00623467|147616537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|1.25|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
73944286|NCT00279201|147421197|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||<0.001
73944287|NCT00279201|147421198|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||0.032
73944288|NCT00279201|147421199|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.037
73944289|NCT00279201|147421199|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.025
73944290|NCT00279201|147421199|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.132
73975654|NCT02307682|147496022|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-8.4|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||1.8|-8.4|
73975655|NCT02307682|147496022|OTHER||Difference in proportions|-3.3|||||TWO_SIDED|95.0|-8.5|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||1.5|-8.5|
73975656|NCT02307682|147496022|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-9.8|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.2|-9.8|
73975657|NCT02307682|147496022|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.4|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||-0.7|-10.4|
73975658|NCT02307682|147496022|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-7.4|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.0|-7.4|
73975659|NCT02307682|147496022|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-11.0|-1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-1.1|-11.0|
73975660|NCT02307682|147496022|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.9|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.1|-4.9|
73975661|NCT02307682|147496022|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-7.6|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||1.4|-7.6|
73975662|NCT02307682|147496022|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-5.3|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||5.1|-5.3|
73944291|NCT00279201|147421199|SUPERIORITY_OR_OTHER|||||||0.849||95.0||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.849
73975663|NCT02307682|147496022|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-8.5|0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.8|-8.5|
73975664|NCT02307682|147496023|OTHER||Difference in proportions|-6.7|||||TWO_SIDED|95.0|-14.1|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.2|-14.1|
73975665|NCT02307682|147496023|OTHER||Difference in proportions|-7.4|||||TWO_SIDED|95.0|-15.3|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-0.3|-15.3|
73975666|NCT02307682|147496023|OTHER||Difference in proportions|-9.3|||||TWO_SIDED|95.0|-16.6|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.2|-16.6|
74031560|NCT00623467|147616538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_DEVIATION|1.39|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
73944292|NCT00279201|147421200|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for Sulfonylurea/TZD|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.006
73944293|NCT00279201|147421200|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.048
74031561|NCT00623467|147616538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|1.3|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
73944294|NCT00279201|147421200|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.258
73944295|NCT00279201|147421200|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.848
73944296|NCT00279201|147421201|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.004
73944297|NCT00279201|147421202|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.553
73944298|NCT00279201|147421203|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value is for Mean of all post meals blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.010
73944299|NCT00279201|147421203|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-value is for Average of all blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.035
73944300|NCT00279201|147421204|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value is for Mean of post-meals blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.516
73944301|NCT00279201|147421204|SUPERIORITY_OR_OTHER|||||||0.425||95.0||||P-value is for Average of all blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.425
73944302|NCT00279201|147421205|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.770
73975667|NCT02307682|147496023|OTHER||Difference in proportions|-12.1|||||TWO_SIDED|95.0|-19.7|-5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-5.4|-19.7|
73944303|NCT00279201|147421205|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
73944304|NCT00279201|147421205|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.552
73944305|NCT00279201|147421205|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
73944306|NCT00279201|147421206|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for \<=7.0%.|Fisher Exact|||||||0.027
73944307|NCT00279201|147421206|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for \<7.0%.|Fisher Exact|||||||0.021
73944308|NCT00279201|147421206|SUPERIORITY_OR_OTHER|||||||0.799||95.0||||P-value is for \<=6.5%.|Fisher Exact|||||||0.799
73944309|NCT00279201|147421206|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||P-value is for \<=7.0%.|Fisher Exact|||||||0.676
73975668|NCT02307682|147496023|OTHER||Difference in proportions|-8.2|||||TWO_SIDED|95.0|-14.8|-1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.6|-14.8|
73944310|NCT00279201|147421206|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for \<7.0%.|Fisher Exact|||||||1.000
73944311|NCT00279201|147421206|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for \<=6.5%.|Fisher Exact|||||||1.000
73944312|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.241
73944313|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.305||95.0||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.305
73944314|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.842||95.0||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.842
73944315|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.917||95.0||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.917
73944316|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.648||95.0||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.648
73944317|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.613||95.0||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.613
73944318|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.813
73944319|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.953
73944320|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.933
73944321|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.348
73944322|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.625||95.0||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.625
73944323|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.573||95.0||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.573
73975669|NCT02307682|147496023|OTHER||Difference in proportions|-10.2|||||TWO_SIDED|95.0|-17.4|-3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-3.9|-17.4|
73975670|NCT02307682|147496023|SUPERIORITY||Difference in proportions|-10.2||||0.003|TWO_SIDED|95.0|-17.3|-2.5||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.5|-17.3|0.0030
73975671|NCT02307682|147496023|SUPERIORITY||Difference in proportions|-18.2|||<|0.0001|TWO_SIDED|95.0|-25.3|-10.9||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-10.9|-25.3|<0.0001
73944324|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.711||95.0||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.711
73975672|NCT02307682|147496023|OTHER||Difference in proportions|12.0|||||TWO_SIDED|95.0|5.2|19.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||19.0|5.2|
73975673|NCT02307682|147496023|OTHER||Difference in proportions|11.1|||||TWO_SIDED|95.0|3.8|18.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||18.2|3.8|
73975674|NCT02307682|147496023|OTHER||Difference in proportions|-10.6|||||TWO_SIDED|95.0|-17.7|-3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.1|-17.7|
73975675|NCT02307682|147496023|OTHER||Difference in proportions|-23.2|||||TWO_SIDED|95.0|-30.5|-16.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-16.1|-30.5|
73975676|NCT02307682|147496023|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.8|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||9.0|-4.8|
73975677|NCT02307682|147496023|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-11.8|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.5|-11.8|
73975678|NCT02307682|147496023|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-12.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.1|-12.0|
73975679|NCT02307682|147496023|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-18.0|-3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-3.2|-18.0|
73975680|NCT02307682|147496023|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-12.5|0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||0.8|-12.5|
73944325|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.372
73944326|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.516
73944327|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.639
73975681|NCT02307682|147496023|OTHER||Difference in proportions|-9.2|||||TWO_SIDED|95.0|-16.2|-2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.4|-16.2|
73975682|NCT02307682|147496023|OTHER||Difference in proportions|-8.2|||||TWO_SIDED|95.0|-15.7|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.6|-15.7|
73975683|NCT02307682|147496023|OTHER||Difference in proportions|-13.0|||||TWO_SIDED|95.0|-20.5|-5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-5.5|-20.5|
74031562|NCT00623467|147616538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_DEVIATION|1.02|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74031563|NCT00623467|147616539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_DEVIATION|1.32|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
73944328|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.131
73944329|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.530
73944330|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.578
73944331|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.004
73944332|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.951||95.0||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.951
73975684|NCT02307682|147496023|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-0.8|13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||13.0|-0.8|
73975685|NCT02307682|147496023|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-7.5|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.6|-7.5|
73975686|NCT02307682|147496023|SUPERIORITY||Difference in proportions|-10.5||||0.002|TWO_SIDED|95.0|-17.4|-3.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-3.3|-17.4|0.0020
73975687|NCT02307682|147496023|SUPERIORITY||Difference in proportions|-13.5||||0.0001|TWO_SIDED|95.0|-20.7|-6.1||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-6.1|-20.7|0.0001
73975688|NCT02307682|147496023|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.4|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.1|-5.4|
73944333|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.580
73944334|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.071
73944335|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.081
73975689|NCT02307682|147496023|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-11.8|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||1.2|-11.8|
73975690|NCT02307682|147496023|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-10.3|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.7|-10.3|
73944336|NCT00279201|147421207|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||<0.001
73944337|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.542||95.0||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.542
74089237|NCT02697773|147731603|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.24||0.0065|TWO_SIDED|95.0|-1.14|-0.19||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed data sets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.19|-1.14|0.0065
73944338|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.003
73944339|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.105||95.0||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.105
73944340|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.487
73944341|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.491
73944342|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.127
73944343|NCT00279201|147421207|SUPERIORITY_OR_OTHER|||||||0.861||95.0||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.861
73944344|NCT00279201|147421208|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.745
73944345|NCT00279201|147421208|SUPERIORITY_OR_OTHER|||||||0.467||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.467
73944346|NCT00279201|147421208|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.575
73944347|NCT00279201|147421208|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.726
73944348|NCT00279201|147421208|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.978
73944349|NCT00279201|147421208|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.345
73944350|NCT00279201|147421208|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.166
73944351|NCT00279201|147421208|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.064
73944352|NCT00279201|147421208|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.199
73944353|NCT00279201|147421208|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.098
73944354|NCT00279201|147421209|SUPERIORITY_OR_OTHER|||||||0.467||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.||||||0.467
73944355|NCT00279201|147421209|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.575
73944356|NCT00279201|147421209|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.726
73944357|NCT00279201|147421209|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.978
73944358|NCT00279201|147421209|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.345
73944359|NCT00279201|147421209|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.||||||0.745
73944360|NCT00279201|147421209|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.166
73944361|NCT00279201|147421209|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.064
73944362|NCT00279201|147421209|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.199
73944363|NCT00279201|147421209|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.098
73944364|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.837
73944365|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.205
73944366|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.704
73944367|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.610
73944368|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.352
74031564|NCT00623467|147616539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.27|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74031565|NCT00623467|147616539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.99|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74031566|NCT00623467|147616540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|0.48|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
73944369|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.636
73944370|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.880
73944371|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.904||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.904
73944372|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.859
73944373|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.654
73944374|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.566
73944375|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.926||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.926
73944376|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.902
73944377|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.766
73944378|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.449||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.449
73944379|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.797
73944380|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.438
73944381|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.602
74031567|NCT00623467|147616540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_DEVIATION|0.46|<|0.0001||||||for border delineation|paired t test|||||||<0.0001
74031568|NCT00623467|147616540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|0.32|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74031569|NCT00623467|147616541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|STANDARD_DEVIATION|0.4|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
74031570|NCT00623467|147616541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|STANDARD_DEVIATION|0.38|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74031571|NCT00623467|147616541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_DEVIATION|0.34|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
73944382|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.493||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.493
73944383|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.335||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.335
73944384|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.398||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.398
73944385|NCT00279201|147421210|SUPERIORITY_OR_OTHER|||||||0.903||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.903
73944386|NCT00279201|147421211|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for Hypoglycemia episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.953
73944387|NCT00279201|147421211|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.953
73944388|NCT00279201|147421211|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.188
73944389|NCT00279201|147421211|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.226
73944390|NCT00279201|147421211|SUPERIORITY_OR_OTHER|||||||0.855||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.855
73944391|NCT00279201|147421211|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P-value is for Hypoglycemia episodes at endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.250
73944392|NCT00279201|147421211|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.123
73944393|NCT00279201|147421211|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.166
73944394|NCT00279201|147421211|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.273
73944395|NCT00279201|147421211|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.039
73944396|NCT00279201|147421212|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.623
73944397|NCT00279201|147421212|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-value is for Hypoglycemic episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.949
73944398|NCT00279201|147421212|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.730
74031572|NCT00623467|147616542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21|STANDARD_DEVIATION|0.37|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
74031573|NCT00623467|147616542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|STANDARD_DEVIATION|0.45|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74031574|NCT00623467|147616542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.3|<|0.0001||||||for internal morphology|paired t test|||||||<0.0001
74089238|NCT02697773|147731603|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.37|-0.42||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-1.37|0.0002
74031575|NCT00623467|147616543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.32|STANDARD_DEVIATION|0.34|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
74089239|NCT02697773|147731604|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.0109|TWO_SIDED|95.0|-0.39|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.39|0.0109
74089240|NCT02697773|147731604|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0038|TWO_SIDED|95.0|-0.41|-0.08||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.41|0.0038
74089241|NCT02697773|147731605|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.21||0.002|TWO_SIDED|95.0|-1.08|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.24|-1.08|0.0020
74031576|NCT00623467|147616543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_DEVIATION|0.3|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
73944399|NCT00279201|147421212|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.445
73944400|NCT00279201|147421212|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.949
74031577|NCT00623467|147616543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_DEVIATION|0.22|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74031578|NCT00623467|147616545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_DEVIATION|1.0|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
74031579|NCT00623467|147616545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|0.9|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74031580|NCT00623467|147616546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_DEVIATION|0.63|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
74031581|NCT00623467|147616546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_DEVIATION|0.64|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74031582|NCT00623467|147616547|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.4||||0.0002|||||||McNemar|||||||0.0002
74031583|NCT00623467|147616548|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.3||||0.0001|||||||McNemar|||||||0.0001
74031584|NCT00623467|147616549|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.0285|||||||McNemar|||||||0.0285
74031585|NCT00623467|147616550|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.5||||0.0004|||||||McNemar|||||||0.0004
73944401|NCT00279201|147421212|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.590
74031586|NCT00623467|147616551|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.5||||0.0588|||||||McNemar|||||||0.0588
74031587|NCT00623467|147616552|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.0093|||||||McNemar|||||||0.0093
74031588|NCT00623467|147616553|SUPERIORITY_OR_OTHER||Risk Difference (RD)|20.6||||0.0003|||||||McNemar|||||||0.0003
74031589|NCT00623467|147616554|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||1|||||||McNemar|||||||1.0000
74031590|NCT00623467|147616555|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.8||||0.0016|||||||McNemar|||||||0.0016
74031591|NCT00623467|147616556|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.9||||0.0253|||||||McNemar|||||||0.0253
74089242|NCT02697773|147731605|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.21||0.0014|TWO_SIDED|95.0|-1.1|-0.26|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.10|0.0014
74089243|NCT02697773|147731605|SUPERIORITY||Least Square Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.31|-0.45|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.45|-1.31|<.0001
73944402|NCT00279201|147421212|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.657
73944403|NCT00279201|147421212|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.108
73944404|NCT00279201|147421212|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.161
73944405|NCT00279201|147421212|SUPERIORITY_OR_OTHER|||||||0.178||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.178
73944406|NCT00279201|147421213|SUPERIORITY_OR_OTHER|||||||0.917||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.917
73944407|NCT00279201|147421213|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||P-value for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.754
73944408|NCT00279201|147421213|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.||||||0.420
73944409|NCT00279201|147421213|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-value for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.||||||0.514
73944410|NCT00279201|147421214|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.770
73944411|NCT00279201|147421214|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.566
73944412|NCT00279201|147421214|SUPERIORITY_OR_OTHER|||||||0.812||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.812
73944413|NCT00279201|147421214|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
73944414|NCT00279201|147421214|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.552
73944415|NCT00279201|147421214|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.179
73944416|NCT00279201|147421214|SUPERIORITY_OR_OTHER|||||||0.377||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.377
73944417|NCT00279201|147421214|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
73944418|NCT00985010|147421215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|5.0||0.05|||||||Chi-squared||The difference is between the percentage of deaths (males versus females) after six months in the patients with hepatic encephalophathy.|Clinical evolution was reported as percentage (still alive or death after six months of follow up).||||0.05
73944419|NCT00985010|147421216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.05|STANDARD_DEVIATION|10.72||0.05||95.0|||||Wilcoxon (Mann-Whitney)||The difference is between manganese levels of women minus manganese levels of men.|Laboratory results were expressed in means and standard deviations. Between group comparisons (female versus male values) were made with the Mann-Whitney U test using the Statistical Package for Social Sciences (SPSS) program version 10 (SPSS Inc., North Carolina, USA).||||0.05
73944420|NCT00511875|147421231|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
73944421|NCT00511875|147421232|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Foveal Sensitivity||||.33
73944422|NCT00511875|147421232|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Mean field sensitivity||||.16
73944423|NCT00511875|147421233|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Foveal Sensitivity||||.02
73944424|NCT00511875|147421233|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||mean FDP sensitivity||||.3
73944425|NCT00511875|147421234|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||.98
73944426|NCT00511875|147421235|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||.46
73944427|NCT00511875|147421236|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||.81
73944428|NCT00511875|147421237|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||.88
73944429|NCT00511875|147421238|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||.75
73944430|NCT00511875|147421239|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||.62
73944431|NCT00696384|147421256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|||<|0.001|TWO_SIDED|95.0|-9.78|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA|||||-5.78|-9.78|<0.001
73944432|NCT00696384|147421257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-15.47|-9.29||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA|||||-9.29|-15.47|<0.001
73944433|NCT01678131|147421262|SUPERIORITY_OR_OTHER_LEGACY||Posterior Percentage Probability|100.0||||||||||||||The posterior percentage probability of the true success rate of the FNA procedure for the 3 combined treatment groups (n=29) was determined by a Bayesian calculation, using a Jeffrey's prior distribution (i.e. Beta \[0.5,0.5\]) on the true success rate. Neither P-values, nor confidence intervals are estimated in this analysis. The primary hypothesis was met if the posterior percentage probability was \> 80% that the true success rate is at least 60%.||||
74031592|NCT00623467|147616557|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.5||||0.0253|||||||McNemar|||||||0.0253
74031593|NCT00623467|147616558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|0.7|<|0.0001|||||||paired t-test|||||||< 0.0001
74031594|NCT00623467|147616559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_DEVIATION|0.81|<|0.0001|||||||paired t-test|||||||< 0.0001
74031595|NCT02795988|147616572|SUPERIORITY||Cox proportional hazard regression model|0.603||||0.078|TWO_SIDED|80.0|0.38|0.957||1-sided p-value was calculated from Log-rank test stratified by factor tumor stage which used for randomization at screening.|Log Rank|||||0.957|0.380|0.078
74031596|NCT04705597|147616595|SUPERIORITY||Odds Ratio (OR)|1.366||||0.3312|TWO_SIDED|95.0|0.728|2.562|||Regression, Logistic|||||2.562|0.728|0.3312
73944434|NCT00811382|147421312|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
74031597|NCT04705597|147616597|SUPERIORITY||Odds Ratio (OR)|0.574||||0.4561|TWO_SIDED|95.0|0.133|2.475|||Regression, Logistic|||Day 14||2.475|0.133|0.4561
73944435|NCT00685945|147421334|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||The effect of bradykinin on net t-PA release was determined using general linear model-repeated measures ANOVA in which the between-subject variable was gender, and the within-subjects variables were drug (control, +L-NMMA, +L-NMMA plus isosorbide, or +L-NMMA plus sildenafil) and dose of bradykinin.||||0.04
73944436|NCT00685945|147421335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Repeated measures ANOVA||||||<0.001
73944437|NCT03183388|147421337|OTHER|Mixed model with time (baseline and endpoint) as within-subjects factor; compare Least Square (LS) estimate of endpoint minus baseline to zero. The best-fitting model was chosen based on information criteria.|Endpoint minus Baseline|-3.04|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-4.14|-1.93|||t-test, 2 sided|||||-1.93|-4.14|0.0001
73944438|NCT03183388|147421338|OTHER|Mixed model with time (baseline and midpoint) as within-subjects factor; compare LS estimate of midpoint minus baseline to zero.|Midpoint minus Baseline|-1.37|STANDARD_ERROR_OF_MEAN|2.51||0.6|TWO_SIDED|95.0|-6.97|4.23|||t-test, 2 sided|||||4.23|-6.97|0.60
74031598|NCT04705597|147616597|SUPERIORITY||Odds Ratio (OR)|0.521||||0.1559|TWO_SIDED|95.0|0.212|1.282|||Regression, Logistic|||Day 28||1.282|0.212|0.1559
74031599|NCT04705597|147616597|SUPERIORITY||Odds Ratio (OR)|0.498||||0.1293|TWO_SIDED|95.0|0.203|1.226|||Regression, Logistic|||Day 57||1.226|0.203|0.1293
73944439|NCT03183388|147421339|OTHER|Mixed model with time (baseline and endpoint) as within-subjects factor; compare LS estimate of endpoint minus baseline to zero.|Endpoint minus Baseline|0.11|STANDARD_ERROR_OF_MEAN|0.016||0.0001|TWO_SIDED|95.0|0.074|0.146|||t-test, 2 sided|||||0.146|0.074|0.0001
73944440|NCT03183388|147421340|OTHER|Mixed model with time (baseline and midpoint) as within-subjects factor; compare LS estimate of midpoint minus baseline to zero.|Midpoint minus Baseline|0.031|STANDARD_ERROR_OF_MEAN|0.055||0.58|TWO_SIDED|95.0|-0.095|0.157|||t-test, 2 sided|||||0.157|-0.095|0.58
73944441|NCT00071721|147421349|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.958||||0.88||95.0|||||Cox Proportional Hazards|||||||0.88
73944442|NCT03091673|147421413|OTHER||||||<|0.001||||||P-value was computed using a t-test to determine if change in plasma glucose from baseline to 30 minutes was zero.|t-test, 2 sided|||||||<0.001
73944443|NCT02276066|147421425|OTHER|We performed a delta analysis, by graphing the difference between the two measurements, we wanted to visually assess the degree of agreement or discrepancy between the two methods. We were looking to evaluate the consistency, accuracy, or bias between different measurement techniques.|||||<|0.05|||||||Delta analysis|||||||<0.05
73944444|NCT02802501|147421435|SUPERIORITY||Hazard Ratio (HR)|0.444|||<|0.001|TWO_SIDED|95.0|0.285|0.693|||Cox Proportional Hazard||If hazard ratio was found to be \<1 then there are lower chances of relapse with Tafenoquine+DHA-PQP compared to DHA-PQP only.|||0.693|0.285|<0.001
73944445|NCT02802501|147421436|SUPERIORITY||Hazard Ratio (HR)|1.722|||||TWO_SIDED|95.0|1.031|2.875|||||If hazard ratio was found to be \>1 then there are higher chances of relapse with Tafenoquine+DHA-PQP compared to Primaquine+DHA-PQP.|||2.875|1.031|
73944446|NCT02802501|147421437|SUPERIORITY||Hazard Ratio (HR)|0.258|||||TWO_SIDED|95.0|0.155|0.431|||||If hazard ratio was found to be \<1 then there are lower chances of relapse with Primaquine+DHA-PQP compared to DHA-PQP only.|||0.431|0.155|
73944447|NCT02802501|147421438|SUPERIORITY||Hazard Ratio (HR)|0.433|||||TWO_SIDED|95.0|0.273|0.686|||||If hazard ratio was found to be \<1 then there are lower chances of relapse with Tafenoquine+DHA-PQP compared to DHA-PQP only.|||0.686|0.273|
73869523|NCT00066963|147283124|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.8|||<|0.001|TWO_SIDED|95.0|1.9|7.6|||Mantel Haenszel|2 d.f.|Counseling Only vs FV 2x/yr+Counseling|Planned sample size of 384 participants (128/study arm) (alpha = 0.05, power = 90%, 50% attrition, χ2 test) to detect caries incidence differences, based on caries incidence in the literature (20% to 50% over two years). 50% attrition in the sample size calculation was selected based on the literature (e.g. Weinstein et al., 1994 reported 53% attrition in six months.)||7.6|1.9|<0.001
73869524|NCT00988091|147283125|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.33||||0.034|TWO_SIDED|95.0|0.41|10.24||The p-value was not adjusted for multiple comparisons because there was a single treatment comparison for the primary endpoint. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||A treatment difference of \>=7.0 mm and a pooled SD of 27.6 mm, requires a sample size of 244 subjects/treatment to complete the trial at 80% power at a two-sided significance level of 5%. To account for 18% dropout rate, the sample size was increased to 298/arm (total of 596). The primary null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||10.24|0.41|0.034
73869525|NCT00988091|147283126|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.89||||0.175|TWO_SIDED|95.0|-1.29|7.08||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||7.08|-1.29|0.175
73869526|NCT00988091|147283127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.777||||0.193|TWO_SIDED|95.0|0.532|1.136||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||1.136|0.532|0.193
73944448|NCT01342458|147421477|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Mixed Models Analysis|||Sample size was calculated based on pain WOMAC score and was accomplished using a moderate effect size (f=0.30). Standard deviation estimates were taken from our previous study. A sample size of 56 patients was needed to provide 80% power for detecting a moderate effect difference between the highest and lowest group pain means, with an alpha level of 0.05, a statistical design of F test of repeated measures (between and within effects), and assuming a 10% loss to follow-up.||||0.006
73944449|NCT01342458|147421477|SUPERIORITY_OR_OTHER||Effect Size|1.46|||<|0.001|TWO_SIDED||||||post hoc newman keuls|||From baseline to 3rd month.||||<0.001
74031600|NCT04705597|147616598|SUPERIORITY|||||||0.2687|||||||Log Rank|||Statistical analysis was only performed for Day 28. This is timeframe used for the primary endpoint||||0.2687
74031601|NCT04705597|147616599|SUPERIORITY|||||||0.3977|||||||Log Rank|||||||0.3977
73944450|NCT01342458|147421477|SUPERIORITY_OR_OTHER||Effect size|1.94|||<|0.001|TWO_SIDED||||||post hoc Newman Keuls|||From baseline to 6th month.||||<0.001
73944451|NCT01342458|147421477|SUPERIORITY_OR_OTHER||Effect size|0.82||||0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||0.001
73944452|NCT01342458|147421477|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
73944453|NCT01342458|147421478|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.015
73944454|NCT01342458|147421478|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
73944455|NCT01342458|147421478|SUPERIORITY_OR_OTHER||Effect size|0.7|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
73944456|NCT01342458|147421478|SUPERIORITY_OR_OTHER||Effect size|0.25|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
73944457|NCT01342458|147421478|SUPERIORITY_OR_OTHER||Effect size|0.16|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
73944458|NCT01342458|147421479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||<0.001
74031602|NCT04705597|147616600|SUPERIORITY|||||||0.2229|||||||Log Rank|||||||0.2229
73944459|NCT01342458|147421479|SUPERIORITY_OR_OTHER||Effect size|1.28|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
73944460|NCT01342458|147421479|SUPERIORITY_OR_OTHER||Effect size|1.58|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
74031603|NCT04705597|147616601|SUPERIORITY||Odds Ratio (OR)|1.388||||0.2941|TWO_SIDED|95.0|0.752|2.561|||Regression, Logistic|||||2.561|0.752|0.2941
74031604|NCT04705597|147616602|SUPERIORITY|||||||0.3325|||||||Log Rank|||||||0.3325
74031605|NCT04705597|147616603|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.0254|TWO_SIDED|95.0|0.08|1.2||Change at Day 14|ANCOVA|||||1.2|0.08|0.0254
74031606|NCT04705597|147616603|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.1109|TWO_SIDED|95.0|-0.12|1.18|||ANCOVA|||Change at Day 28||1.18|-0.12|0.1109
73944461|NCT01342458|147421479|SUPERIORITY_OR_OTHER||Effect size|0.68|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
74031607|NCT04705597|147616603|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.864|TWO_SIDED|95.0|-0.1|0.12|||ANCOVA|||Change at Day 57||0.12|-0.10|0.8640
74031608|NCT04705597|147616604|SUPERIORITY||Odds Ratio (OR)|2.046||||0.0919|TWO_SIDED|95.0|0.89|4.706|||Regression, Logistic|||||4.706|0.89|0.0919
74031609|NCT04705597|147616605|SUPERIORITY||Mean Difference (Final Values)|3.83||||0.749|TWO_SIDED|95.0|-0.42|8.08|||ANCOVA|||||8.08|-0.42|0.749
74031610|NCT04705597|147616606|SUPERIORITY||Mean Difference (Final Values)|3.69||||0.1769|TWO_SIDED|95.0|-1.75|9.13|||ANCOVA|||||9.13|-1.75|0.1769
74031611|NCT04705597|147616607|SUPERIORITY||Odds Ratio (OR)|0.54||||0.2621|TWO_SIDED|95.0|0.184|1.586|||Regression, Logistic|||||1.586|0.184|0.2621
73944462|NCT01342458|147421479|SUPERIORITY_OR_OTHER||Effect size|0.42|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
73869527|NCT00988091|147283128|SUPERIORITY_OR_OTHER|||||||0.887||95.0||||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Cochran-Mantel-Haenszel|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||||0.887
73944463|NCT01342458|147421480|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||<0.001
73944464|NCT01342458|147421480|SUPERIORITY_OR_OTHER||Effect size|1.45|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
73944465|NCT01342458|147421480|SUPERIORITY_OR_OTHER||Effect size|1.69||||0.019|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||0.019
73944466|NCT01342458|147421480|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
73944467|NCT01342458|147421480|SUPERIORITY_OR_OTHER||Effect size|0.44|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
73944468|NCT01342458|147421481|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.019
73944469|NCT01342458|147421481|SUPERIORITY_OR_OTHER||Effect size|1.07|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
73944470|NCT01342458|147421481|SUPERIORITY_OR_OTHER||Effect size|1.31|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
73944471|NCT01342458|147421481|SUPERIORITY_OR_OTHER||Effect size|0.71|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
73944472|NCT01342458|147421481|SUPERIORITY_OR_OTHER||Effect size|0.45|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
74031612|NCT04705597|147616608|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.2265|TWO_SIDED|95.0|-1.76|7.37|||ANCOVA|||||7.37|-1.76|0.2265
73944473|NCT01342458|147421482|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.425
73944474|NCT01342458|147421483|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.443
73944475|NCT01342458|147421484|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference in paracetamol intake at 6-month.||||<0.001
74031613|NCT04705597|147616609|SUPERIORITY||Odds Ratio (OR)|1.223||||0.5497|TWO_SIDED|95.0|0.633|2.364|||Regression, Logistic|||||2.364|0.633|0.5497
74031614|NCT04705597|147616610|SUPERIORITY||Mean Difference (Final Values)|4.89||||0.1172|TWO_SIDED|95.0|-1.27|11.05|||ANCOVA|||||11.05|-1.27|0.1172
74031615|NCT04705597|147616611|SUPERIORITY||Odds Ratio (OR)|0.914||||0.853|TWO_SIDED|95.0|0.353|2.368|||Regression, Logistic|||||2.368|0.353|0.853
73944476|NCT00530062|147421507|OTHER||Difference in adjusted mean|0.946||||0.5595|TWO_SIDED|95.0|-2.293|4.185||Threshold for significance at 0.05 level.|ANCOVA|||The analysis was performed using the mixed-effect analysis of variance with fixed effects of center, sequence, treatment group and period, and random effect of the participant within sequence.||4.185|-2.293|0.5595
73944477|NCT01376323|147421523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.13|0.6||||||||0.60|-0.13|
73944478|NCT01376323|147421523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.37|0.35||||||||0.35|-0.37|
73944479|NCT01376323|147421523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.49|0.23||||||||0.23|-0.49|
73944480|NCT01376323|147421523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.66|0.06||||||||0.06|-0.66|
73944481|NCT01376323|147421524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.551|||||TWO_SIDED|95.0|-1.645|0.543|||||Comparison for glucose.|||0.543|-1.645|
73944482|NCT01376323|147421524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.382|||||TWO_SIDED|95.0|-1.472|0.708|||||Comparison for glucose.|||0.708|-1.472|
73944483|NCT01376323|147421524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|||||TWO_SIDED|95.0|-1.696|0.516|||||Comparison for glucose.|||0.516|-1.696|
73944484|NCT01376323|147421524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.595|||||TWO_SIDED|95.0|-1.669|0.48|||||Comparison for glucose.|||0.480|-1.669|
73944485|NCT01376323|147421524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.036|||||TWO_SIDED|95.0|-0.042|0.113|||||Comparison for NEFA.|||0.113|-0.042|
73944486|NCT01376323|147421524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|||||TWO_SIDED|95.0|-0.073|0.081|||||Comparison for NEFA.|||0.081|-0.073|
73944487|NCT01376323|147421524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|||||TWO_SIDED|95.0|-0.058|0.099|||||Comparison for NEFA.|||0.099|-0.058|
73944488|NCT01376323|147421524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083|||||TWO_SIDED|95.0|-0.16|-0.007|||||Comparison for NEFA.|||-0.007|-0.160|
73944489|NCT01376323|147421526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.79|0.94||||||||0.94|-0.79|
74031616|NCT04705597|147616612|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.1991|TWO_SIDED|95.0|-1.86|8.18|||ANCOVA|||||8.18|-1.86|0.1991
74031617|NCT04705597|147616613|SUPERIORITY||Odds Ratio (OR)|4.103||||0.0166|TWO_SIDED|95.0|1.293|13.027|||Regression, Logistic|||||13.027|1.293|0.0166
74031618|NCT04705597|147616614|SUPERIORITY||Mean Difference (Final Values)|4.56||||0.1297|TWO_SIDED|95.0|-1.51|10.64|||ANCOVA|||||10.64|-1.51|0.1297
74031619|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.1916|TWO_SIDED|95.0|-0.35|0.07|||ANCOVA|||Baseline||0.07|-0.35|0.1916
73869528|NCT00988091|147283130|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.0||||0.116|TWO_SIDED|95.0|-0.99|8.98||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||8.98|-0.99|0.116
73869529|NCT00988091|147283131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.081|TWO_SIDED|95.0|0.483|1.044||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.\[||1.044|0.483|0.081
73944490|NCT01376323|147421526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.9|0.82||||||||0.82|-0.90|
74031620|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.1097|TWO_SIDED|95.0|-0.44|0.05|||ANCOVA|||Treatment Day 2||0.05|-0.44|0.1097
74031621|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0276|TWO_SIDED|95.0|-0.63|-0.04|||ANCOVA|||Treatment Day 3||-0.04|-0.63|0.0276
74031622|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0463|TWO_SIDED|95.0|-0.71|-0.01|||ANCOVA|||Treatment Day 4||-0.01|-0.71|0.0463
74031623|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0969|TWO_SIDED|95.0|-0.71|0.06|||ANCOVA|||Treatment Day 5||0.06|-0.71|0.0969
74031624|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.4367|TWO_SIDED|95.0|-0.57|0.25|||ANCOVA|||Treatment Day 6||0.25|-0.57|0.4367
74031625|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.6685|TWO_SIDED|95.0|-0.54|0.35|||ANCOVA|||Treatment Day 7||0.35|-0.54|0.6685
74031626|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.2287|TWO_SIDED|95.0|-0.73|0.18|||ANCOVA|||Treatment Day 8||0.18|-0.73|0.2287
74031627|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.1061|TWO_SIDED|95.0|-0.96|0.09|||ANCOVA|||Treatment Day 9||0.09|-0.96|0.1061
74031628|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.0415|TWO_SIDED|95.0|-1.06|-0.02|||ANCOVA|||Treatment Day 10||-0.02|-1.06|0.0415
74031629|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.1236|TWO_SIDED|95.0|-1.0|0.12|||ANCOVA|||Treatment Day 11||0.12|-1.00|0.1236
74031630|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.0097|TWO_SIDED|95.0|-1.23|-0.18|||ANCOVA|||Treatment Day 12||-0.18|-1.23|0.0097
74031631|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.0157|TWO_SIDED|95.0|-1.02|-0.11|||ANCOVA|||Treatment Day 13||-0.11|-1.02|0.0157
74031632|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.001|TWO_SIDED|95.0|-1.32|-0.36|||ANCOVA|||Treatment Day 14||-0.36|-1.32|0.0010
74031633|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.644|TWO_SIDED|95.0|-0.4|0.25|||ANCOVA|||Time of Discharge Visit||0.25|-0.40|0.6440
74031634|NCT04705597|147616615|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9869|TWO_SIDED|95.0|-0.6|0.59|||ANCOVA|||Follow up Day 28||0.59|-0.60|0.9869
74031635|NCT04705597|147616616|SUPERIORITY||Mean Difference (Final Values)|1.69||||0.2399|TWO_SIDED|95.0|-1.14|4.52|||ANCOVA|||||4.52|-1.14|0.2399
74031636|NCT04705597|147616617|SUPERIORITY||Odds Ratio (OR)|0.869||||0.8081|TWO_SIDED|95.0|0.28|2.695|||Regression, Logistic|||||2.695|0.28|0.8081
74031637|NCT04705597|147616618|SUPERIORITY||Odds Ratio (OR)|1.436||||0.3193|TWO_SIDED|95.0|0.704|2.929|||Regression, Logistic|||||2.929|0.704|0.3193
74031638|NCT03691623|147616619|SUPERIORITY||LS Mean Difference|-588.08|||<|0.001|TWO_SIDED|95.0|-719.8|-456.35|||ANCOVA|||||-456.35|-719.8|< 0.001
74031639|NCT03691623|147616619|SUPERIORITY||LS Mean Difference|-564.63|||<|0.001|TWO_SIDED|95.0|-689.23|-440.02|||ANCOVA|||||-440.02|-689.23|< 0.001
74031640|NCT03691623|147616619|SUPERIORITY||LS Mean Difference|-716.08|||<|0.001|TWO_SIDED|95.0|-879.92|-552.24|||ANCOVA|||||-552.24|-879.92|< 0.001
74031641|NCT03691623|147616619|SUPERIORITY||LS Mean Difference|-736.23|||<|0.001|TWO_SIDED|95.0|-916.36|-556.11|||ANCOVA|||||-556.11|-916.36|< 0.001
74031642|NCT03691623|147616620|SUPERIORITY||LS Mean Difference|-355.91|||<|0.001|TWO_SIDED|95.0|-506.12|-205.69|||ANCOVA|||||-205.69|-506.12|< 0.001
74031643|NCT03691623|147616620|SUPERIORITY||LS Mean Difference|-326.64|||<|0.001|TWO_SIDED|95.0|-469.68|-183.6|||ANCOVA|||||-183.6|-469.68|< 0.001
74031644|NCT03691623|147616620|SUPERIORITY||LS Mean Difference|-313.98|||=|0.001|TWO_SIDED|95.0|-494.27|-133.69|||ANCOVA|||||-133.69|-494.27|= 0.001
74031645|NCT03691623|147616620|SUPERIORITY||LS Mean Difference|-312.73|||=|0.003|TWO_SIDED|95.0|-508.05|-117.4|||ANCOVA|||||-117.4|-508.05|= 0.003
74031646|NCT03691623|147616621|SUPERIORITY||LS Mean Difference|-3.7|||<|0.001|TWO_SIDED|95.0|-5.3|-2.0|||ANCOVA|||||-2|-5.3|< 0.001
74031647|NCT03691623|147616621|SUPERIORITY||LS Mean Difference|-3.9|||<|0.001|TWO_SIDED|95.0|-5.5|-2.4|||ANCOVA|||||-2.4|-5.5|< 0.001
74031648|NCT03691623|147616621|SUPERIORITY||LS Mean Difference|-3.0|||=|0.002|TWO_SIDED|95.0|-4.9|-1.2|||ANCOVA|||||-1.2|-4.9|= 0.002
74031649|NCT03691623|147616621|SUPERIORITY||LS Mean Difference|-2.9|||=|0.006|TWO_SIDED|95.0|-4.9|-0.9|||ANCOVA|||||-0.9|-4.9|= 0.006
74031650|NCT03691623|147616623|SUPERIORITY||LS Mean Difference|-0.82|||=|0.199|TWO_SIDED|95.0|-2.09|0.44|||ANCOVA|||||0.44|-2.09|= 0.199
74031651|NCT03691623|147616623|SUPERIORITY||LS Mean Difference|0.22|||=|0.714|TWO_SIDED|95.0|-0.98|1.43|||ANCOVA|||||1.43|-0.98|= 0.714
74031652|NCT03691623|147616623|SUPERIORITY||LS Mean Difference|-0.19|||=|0.844|TWO_SIDED|95.0|-2.15|1.77|||ANCOVA|||||1.77|-2.15|= 0.844
74031653|NCT03691623|147616623|SUPERIORITY||LS Mean Difference|-1.34|||=|0.21|TWO_SIDED|95.0|-3.46|0.79|||ANCOVA|||||0.79|-3.46|= 0.21
73944491|NCT01376323|147421526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.9|0.85||||||||0.85|-0.90|
73944492|NCT01376323|147421526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-1.27|0.42||||||||0.42|-1.27|
73944493|NCT01376323|147421527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.27|||||TWO_SIDED|95.0|-48.62|53.16||||||||53.16|-48.62|
73944494|NCT01376323|147421527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.67|||||TWO_SIDED|95.0|-58.04|42.7||||||||42.70|-58.04|
73944495|NCT01376323|147421527|SUPERIORITY_OR_OTHER||Median Difference (Net)|24.08|||||TWO_SIDED|95.0|-27.75|75.92||||||||75.92|-27.75|
73944496|NCT01376323|147421527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|||||TWO_SIDED|95.0|-52.72|48.53||||||||48.53|-52.72|
74031654|NCT03691623|147616624|SUPERIORITY||LS Mean Difference|-1.01|||=|0.145|TWO_SIDED|95.0|-2.37|0.36|||ANCOVA|||||0.36|-2.37|= 0.145
74031655|NCT03691623|147616624|SUPERIORITY||LS Mean Difference|-0.65|||=|0.352|TWO_SIDED|95.0|-2.03|0.73|||ANCOVA|||||0.73|-2.03|= 0.352
74031656|NCT03691623|147616624|SUPERIORITY||LS Mean Difference|-2.85|||=|0.002|TWO_SIDED|95.0|-4.55|-1.15|||ANCOVA|||||-1.15|-4.55|= 0.002
74031657|NCT03691623|147616624|SUPERIORITY||LS Mean Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-5.19|-1.61|||ANCOVA|||||-1.61|-5.19|< 0.001
74031658|NCT03691623|147616625|SUPERIORITY||LS Mean Difference|-24.081|||<|0.001|TWO_SIDED|95.0|-36.554|-11.607|||ANCOVA|||||-11.607|-36.554|< 0.001
74031659|NCT03691623|147616625|SUPERIORITY||LS Mean Difference|-25.954|||<|0.001|TWO_SIDED|95.0|-37.695|-14.213|||ANCOVA|||||-14.213|-37.695|< 0.001
74031660|NCT03691623|147616625|SUPERIORITY||LS Mean Difference|-18.13|||<|0.001|TWO_SIDED|95.0|-27.176|-9.083|||ANCOVA|||||-9.083|-27.176|< 0.001
74031661|NCT03691623|147616625|SUPERIORITY||LS Mean Difference|-19.329|||<|0.001|TWO_SIDED|95.0|-29.106|-9.552|||ANCOVA|||||-9.552|-29.106|< 0.001
74031662|NCT03691623|147616626|SUPERIORITY||LS Mean Difference|-2.1292|||<|0.001|TWO_SIDED|95.0|-2.8491|-1.4093|||ANCOVA|||||-1.4093|-2.8491|< 0.001
74031663|NCT03691623|147616626|SUPERIORITY||LS Mean Difference|-2.1129|||<|0.001|TWO_SIDED|95.0|-2.7938|-1.4319|||ANCOVA|||||-1.4319|-2.7938|< 0.001
73944497|NCT01376323|147421529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.58|||||TWO_SIDED|95.0|-19.36|16.2||||||||16.20|-19.36|
73944498|NCT01376323|147421529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.1|||||TWO_SIDED|95.0|-33.0|2.81||||||||2.81|-33.00|
73944499|NCT01376323|147421529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.09|||||TWO_SIDED|95.0|-32.41|4.23||||||||4.23|-32.41|
73944500|NCT01376323|147421529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.12|||||TWO_SIDED|95.0|-36.55|-1.68||||||||-1.68|-36.55|
73944501|NCT04681729|147421531|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9492|TWO_SIDED|95.0|0.41|2.56||Cochran-Mantel-Haenszel test was performed on the association between the ice cube provocation test result and intervention group, stratified by region and background H1-antihistamine regular/daily use (Yes or No). Threshold of significance at 0.01.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the family-wise type-I error. Testing was then performed sequentially in order the endpoints were reported and continued when primary endpoint was statistically significant at two-sided 0.01.||2.56|0.41|0.9492
73944502|NCT00499863|147421553|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The null hypothesis was that there is no difference between MTS and placebo.||||< 0.001
74031664|NCT03691623|147616626|SUPERIORITY||LS Mean Difference|-3.2191|||<|0.001|TWO_SIDED|95.0|-4.1915|-2.2467|||ANCOVA|||||-2.2467|-4.1915|< 0.001
74031665|NCT03691623|147616626|SUPERIORITY||LS Mean Difference|-2.7831|||<|0.001|TWO_SIDED|95.0|-3.8522|-1.714|||ANCOVA|||||-1.714|-3.8522|< 0.001
74031666|NCT03691623|147616627|SUPERIORITY||LS Mean Difference|-2.01|||<|0.001|TWO_SIDED|95.0|-2.67|-1.35|||ANCOVA|||||-1.35|-2.67|< 0.001
74031667|NCT03691623|147616627|SUPERIORITY||LS Mean Difference|-1.78|||<|0.001|TWO_SIDED|95.0|-2.4|-1.16|||ANCOVA|||||-1.16|-2.4|< 0.001
74031668|NCT03691623|147616627|SUPERIORITY||LS Mean Difference|-1.98|||=|0.009|TWO_SIDED|95.0|-3.43|-0.54|||ANCOVA|||||-0.54|-3.43|= 0.009
74031669|NCT03691623|147616627|SUPERIORITY||LS Mean Difference|-2.41|||=|0.004|TWO_SIDED|95.0|-4.0|-0.82|||ANCOVA|||||-0.82|-4|= 0.004
74031670|NCT03691623|147616628|SUPERIORITY||LS Mean Difference|-2.1|||<|0.001|TWO_SIDED|95.0|-3.04|-1.17|||ANCOVA|||||-1.17|-3.04|< 0.001
74031671|NCT03691623|147616628|SUPERIORITY||LS Mean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.89|-1.11|||ANCOVA|||||-1.11|-2.89|< 0.001
74031672|NCT03691623|147616628|SUPERIORITY||LS Mean Difference|-1.97|||<|0.001|TWO_SIDED|95.0|-3.06|-0.89|||ANCOVA|||||-0.89|-3.06|< 0.001
74031673|NCT03691623|147616628|SUPERIORITY||LS Mean Difference|-2.46|||<|0.001|TWO_SIDED|95.0|-3.64|-1.29|||ANCOVA|||||-1.29|-3.64|< 0.001
74031674|NCT03691623|147616629|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
74031675|NCT03691623|147616629|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
74031676|NCT03691623|147616629|SUPERIORITY||||||=|0.001|||||||Log Rank|||||||= 0.001
74031677|NCT03691623|147616629|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
73944503|NCT00499863|147421554|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
73944504|NCT00499863|147421555|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
73944505|NCT00499863|147421556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
73944506|NCT00499863|147421557|SUPERIORITY_OR_OTHER|||||||0.288||95.0|||||ANCOVA|||||||0.288
73944507|NCT05701995|147421571|SUPERIORITY||Odds Ratio (OR)|7.7||||0.0001|TWO_SIDED|95.0|2.5|23.6|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set||23.6|2.5|0.0001
73944508|NCT05701995|147421571|SUPERIORITY||Odds Ratio (OR)|8.5||||0.0003|TWO_SIDED|95.0|2.4|30.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||30.4|2.4|0.0003
73944509|NCT05701995|147421572|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0107|TWO_SIDED|95.0|1.2|4.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set||4.4|1.2|0.0107
73944510|NCT05701995|147421572|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0175|TWO_SIDED|95.0|1.2|4.7|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||4.7|1.2|0.0175
73944511|NCT05701995|147421573|SUPERIORITY||Adjusted Mean Difference|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.2|||Covariance model|||Full Analysis Set||-1.2|-2.9|<0.0001
73944512|NCT05701995|147421573|SUPERIORITY||Adjusted Mean Difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.3|||Covariance model|||Full Analysis Set Sub-population||-1.3|-3.0|<0.0001
74031678|NCT00972244|147616670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.0987|<|0.0001|TWO_SIDED|95.0|-0.67|-0.28||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.28|-0.67|<0.0001
74031679|NCT00972244|147616670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.1009|<|0.0001|TWO_SIDED|95.0|-0.65|-0.26||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.26|-0.65|<0.0001
74031680|NCT00972244|147616670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.099|<|0.0001|TWO_SIDED|95.0|-0.92|-0.53||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.53|-0.92|<0.0001
74031681|NCT00972244|147616670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.1018|<|0.0001|TWO_SIDED|95.0|-0.99|-0.59||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.59|-0.99|<0.0001
74089244|NCT02697773|147731605|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.3|-0.44|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.44|-1.30|<.0001
73944513|NCT05701995|147421574|SUPERIORITY||Odds Ratio (OR)|5.9||||0.0004|TWO_SIDED|95.0|2.0|17.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||17.4|2.0|0.0004
73944514|NCT02612064|147421615|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.18||||0.1575|TWO_SIDED|95.0|-0.442|0.072|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as a factor and baseline Schiff sensitivity as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||0.072|-0.442|0.1575
73944515|NCT00916032|147421629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103||95.0|||||paired t-test done on the Log(AUC 0-48h)|||||||0.103
73944516|NCT00916032|147421630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||95.0|||||paired t-test done on the Log(AUC 0-48h)|||||||0.162
73944517|NCT01529008|147421659|SUPERIORITY||Proportion treatment responder Differenc|-0.08||||0.539|TWO_SIDED|95.0|-0.35|0.18|||Fisher Exact||"Percentage of treatment responders in PREOB® group is 60.9% ((14/23)\*100), compared with 69.2% ((18/26)\*100) in Placebo.~Difference in percentage is -8.3 Difference in treatment responders proportion: PREOB® (0.609) - Placebo (0.692) = -0.08"|||0.18|-0.35|0.539
73944518|NCT01264380|147421675|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|4.64|||||TWO_SIDED|90.0|2.83|7.6||||||The point estimate and 90 percent (%) confidence interval (CI) of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||7.60|2.83|
73944519|NCT01264380|147421676|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|5.05|||||TWO_SIDED|90.0|2.99|8.55||||||The point estimate and 90% CI of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||8.55|2.99|
73944520|NCT01264380|147421677|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|2.45|||||TWO_SIDED|90.0|1.81|3.32||||||The point estimate and 90% CI of vemurafenib plasma Cmax geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||3.32|1.81|
73958003|NCT03368001|147451531|OTHER|||||||0.448|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses||Quality of Rapport Posttest.||||.448
73944521|NCT01147822|147421684|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0184|||||TWO_SIDED|95.0|0.7658|1.3542|||||The HR was estimated by the Cox regression model using treatment stratification factors as covariates. The HR was adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase.|||1.3542|0.7658|
73944522|NCT01147822|147421685|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.604|TWO_SIDED|95.0|0.808|1.441|||Log Rank||Hazard ratios were estimated using the Pike estimator. A hazard ratio \<1 indicates a lower risk with this treatment compared with Sunitinib.|||1.441|0.808|0.604
73944523|NCT05383417|147421700|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||||||0.03
73944524|NCT05383417|147421701|SUPERIORITY|||||||0.18|||||||t-test, 1 sided|||||||0.18
73944525|NCT05383417|147421702|SUPERIORITY|||||||0.007|||||||t-test, 1 sided|Day 2||||||0.007
73944526|NCT05383417|147421702|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 7||||||0.04
73944527|NCT05383417|147421703|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|Day 1||||||0.03
73975691|NCT02307682|147496023|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-14.1|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||0.4|-14.1|
73975692|NCT02307682|147496023|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.1|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.3|-10.1|
73975693|NCT02307682|147496023|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-14.0|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-0.6|-14.0|
73975694|NCT02307682|147496023|OTHER||Difference in proportions|-7.6|||||TWO_SIDED|95.0|-14.7|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-0.1|-14.7|
73975695|NCT02307682|147496023|OTHER||Difference in proportions|-12.1|||||TWO_SIDED|95.0|-19.5|-5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-5.4|-19.5|
73975696|NCT02307682|147496023|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|0.3|13.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||13.5|0.3|
73975697|NCT02307682|147496023|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-4.9|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.4|-4.9|
73975698|NCT02307682|147496023|OTHER||Difference in proportions|-8.9|||||TWO_SIDED|95.0|-15.7|-1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.7|-15.7|
73975699|NCT02307682|147496023|OTHER||Difference in proportions|-12.5|||||TWO_SIDED|95.0|-19.8|-5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-5.6|-19.8|
73944528|NCT05383417|147421703|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 7||||||0.04
73944529|NCT05383417|147421704|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 1||||||0.04
73944530|NCT05383417|147421705|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|Day2||||||0.02
73944531|NCT05383417|147421706|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73944532|NCT05383417|147421707|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
73944533|NCT05383417|147421708|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73944534|NCT05383417|147421709|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
73944535|NCT05383417|147421710|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73944536|NCT05383417|147421711|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73944537|NCT02466646|147421712|OTHER||Mean Difference (Net)|0.3|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p=0.05|Kruskal-Wallis|||||||<0.01
73944538|NCT02466646|147421713|OTHER||Mean Difference (Net)|2.0|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was P=0.05|Kruskal-Wallis|||||||>0.05
73944539|NCT02466646|147421714|OTHER|||||||0.229||||||Threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.229
73944540|NCT02466646|147421715|OTHER|||||||0.28||||||Threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.280
73944541|NCT02466646|147421716|OTHER|||||||0.712|||||||Kruskal-Wallis|Threshold for statistical significance is p=0.05.||||||0.712
73944542|NCT02466646|147421717|OTHER|||||||0.674||||||The threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.674
73944543|NCT02466646|147421718|OTHER||Mean Difference (Net)|30.0||||0.006|TWO_SIDED|||||The threshold for statistical significance was p=0.05|Kruskal-Wallis|||||||0.006
73975700|NCT02307682|147496023|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.9|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.2|-5.9|
73944544|NCT02466646|147421719|OTHER||Mean Difference (Net)|0.5||||0.373|TWO_SIDED||||||Kruskal-Wallis|||||||0.373
73869530|NCT01973998|147283160|EQUIVALENCE|The primary outcome is time from randomization to a composite outcome of all cause re-hospitalization and all-cause mortality, whichever comes first. The primary analysis will be a log-ranked test and associated Kaplan-Meier plot, unadjusted for any covariates|Hazard Ratio (HR)|1.654|STANDARD_DEVIATION|0.4789|<|0.1|TWO_SIDED|10.0|1.175|2.133||Because this is a pilot study the intent is to see if there is a signal that would justify a larger clinical trial. Therefore the significance level has been set to 0.1 and the power has been set at 0.7.|Log Rank|||||2.133|1.175|<0.1
73944545|NCT02466646|147421720|OTHER||Mean Difference (Net)|0.6||||0.528|TWO_SIDED||||||Kruskal-Wallis|||||||0.528
73944546|NCT02466646|147421721|OTHER||Mean Difference (Net)|1.0||||0.208|TWO_SIDED||||||Kruskal-Wallis|||||||0.208
73944547|NCT02466646|147421722|OTHER|||||||0.051|||||||Kruskal-Wallis|||||||0.051
73944548|NCT02466646|147421723|OTHER|||||||0.647||||||The threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.647
73944549|NCT03261271|147421724|SUPERIORITY|||||||0.6489||||||P value less than 0.05 was considered statistically significant.|Mixed Models Analysis|||||||0.6489
73944550|NCT03261271|147421725|SUPERIORITY|||||||0.0323|||||||Mixed Models Analysis|||||||0.0323
73944551|NCT03261271|147421726|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73944552|NCT03261271|147421727|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73944553|NCT03261271|147421728|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||Difference between groups from Baseline to Study End.||||0.09
73944554|NCT03261271|147421728|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Difference between groups from baseline to pre-surgery.||||0.04
73944555|NCT01932697|147421734|SUPERIORITY|||||||0.01|||||||Paired t-test|||||||.01
73944556|NCT01932697|147421735|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
73944557|NCT01932697|147421736|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
73944558|NCT01932697|147421737|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
73944559|NCT00246337|147421757|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis. Overall power =85%||||0.015
73944560|NCT00246337|147421758|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
73944561|NCT00246337|147421759|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
73944562|NCT00246337|147421760|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
73944563|NCT01226511|147421777|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.03|-1.27|||Mixed Models Analysis|||||-1.27|-4.03|<0.001
73944564|NCT02696564|147421791|SUPERIORITY|We will estimate a 95% confidence interval for the losartan vs placebo mean difference, using the regression estimate and the t-distribution; we will reject the null that losartan is equivalent to placebo if the 95% interval excludes 0.0.||||||0.133|||||||Mixed Models Analysis|P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.||||||0.133
73944565|NCT02696564|147421792|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.762||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.762
73944566|NCT02696564|147421793|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.834||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.834
73944567|NCT02696564|147421794|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.783||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.783
73944568|NCT02696564|147421795|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.053||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.053
73944569|NCT02696564|147421796|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.016||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.016
73944570|NCT02696564|147421797|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.065||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.065
73944571|NCT02696564|147421798|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.293||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.293
73944572|NCT02696564|147421799|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.356||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.356
73958004|NCT03368001|147451531|OTHER|||||||0.15|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses||Social Anxiety Posttest.||||.150
73944573|NCT02696564|147421800|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.009||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.009
73944574|NCT02696564|147421801|SUPERIORITY||Relative rate (losartan to placebo)|0.8||||0.892|TWO_SIDED|95.0|0.03|18.77|||Negative binomial model|||P-value for rate of mild exacerbations between treatment groups (measured in events per 100 person-years).||18.77|0.03|0.892
73944575|NCT02696564|147421801|SUPERIORITY||Relative rate (losartan to placebo)|0.91||||0.946|TWO_SIDED|95.0|0.05|14.97|||Negative binomial model|||P-value for rate of moderate exacerbations between treatment groups (measured in events per 100 person-years).||14.97|0.05|0.946
73944576|NCT02696564|147421801|SUPERIORITY||Relative rate (losartan to placebo)|0.36||||0.487|TWO_SIDED|95.0|0.02|6.51|||Negative binomial model|||P-value for rate of severe exacerbations between treatment groups (measured in events per 100 person-years).||6.51|0.02|0.487
73944577|NCT01337986|147421802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|||||||Mixed Models Analysis|||Per protocol Analysis||||0.84
73944578|NCT01337986|147421802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Mixed Models Analysis|||Change in EDTRS between Visits 2 and 3.||||.29
73944579|NCT01337986|147421804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.01||0.64|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null hypothesis: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity with dalfampridine vs placebo.||||.64
73944580|NCT01337986|147421804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Mixed Models Analysis|||Null hypothesis for period effect: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity for those who started on dalfampridine and crossed over to placebo, compared to those who started on placebo and crossed over to dalfampridine.||||0.11
73944581|NCT01337986|147421805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Regression, Logistic|||||||0.93
74031682|NCT00972244|147616671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.08|STANDARD_ERROR_OF_MEAN|4.7589|<|0.0001|TWO_SIDED|95.0|-35.45|-16.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-16.70|-35.45|<0.0001
74031683|NCT00972244|147616671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.42|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-38.7|-20.14||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-20.14|-38.70|<0.0001
74031684|NCT00972244|147616671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.94|STANDARD_ERROR_OF_MEAN|4.7402|<|0.0001|TWO_SIDED|95.0|-42.28|-23.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-23.60|-42.28|<0.0001
74031685|NCT00972244|147616671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.37|STANDARD_ERROR_OF_MEAN|4.8358|<|0.0001|TWO_SIDED|95.0|-50.9|-31.85||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-31.85|-50.90|<0.0001
74031686|NCT00972244|147616672|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-9.1|7.6||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||7.6|-9.1|1.0000
74031687|NCT00972244|147616672|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.3||||0.2057|TWO_SIDED|95.0|-2.3|18.8||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||18.8|-2.3|0.2057
74031688|NCT00972244|147616672|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.2||||0.6203|TWO_SIDED|95.0|-6.2|13.2||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||13.2|-6.2|0.6203
74031689|NCT00972244|147616672|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.7||||0.205|TWO_SIDED|95.0|-2.0|19.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||19.5|-2.0|0.2050
73944582|NCT01337986|147421806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||Regression, Logistic|||||||.34
73944583|NCT01337986|147421808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.04|TWO_SIDED|95.0|1.02|2.1||Probability of being in the lowest quartile for Visual Field Index deficits.|Regression, Logistic||Odds Ratio for Visual Field Index|||2.10|1.02|0.04
73944584|NCT01337986|147421809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|||||||Regression, Logistic|||||||0.94
73944585|NCT01337986|147421810|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
73944586|NCT01337986|147421811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72|||||||Regression, Linear|||||||0.72
73944587|NCT03170375|147421830|SUPERIORITY|||||||0.28|||||||Regression, Linear|adjusted for baseline carotid-femoral pulse wave velocity||||||0.28
73944588|NCT03170375|147421831|SUPERIORITY|||||||0.6|||||||Regression, Linear|adjusted for baseline left ventricular mass index||||||0.60
73944589|NCT03170375|147421832|SUPERIORITY|||||||0.27|||||||Regression, Linear|adjusted for baseline global left ventricular longitudinal strain||||||0.27
73944590|NCT03170375|147421833|SUPERIORITY|||||||0.03|||||||Regression, Linear|adjusted for baseline carotid-femoral pulse wave velocity||||||0.03
73944591|NCT03170375|147421837|SUPERIORITY|||||||0.47|||||||generalized estimating equations|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.47
73944592|NCT03170375|147421838|SUPERIORITY|||||||0.28|||||||generalized estimating equation|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.28
73944593|NCT03170375|147421839|SUPERIORITY|||||||0.43|||||||generalized estimating equations|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.43
73944594|NCT03170375|147421840|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
73944595|NCT03170375|147421841|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
73944596|NCT01355458|147421847|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||||<0.001
73944597|NCT03532308|147421849|SUPERIORITY|||||||0.76||||||This is for the effect of treatment with time, risk stratification and treatment\*time interaction in the model.|Mixed Models Analysis|||||||0.76
73944598|NCT03720938|147421855|SUPERIORITY|A sample size of 26 children per group was needed with the assumption of Cohen's d = 0.8, the alpha error of 0.05 and a power of 80%.||||||0.001||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.001
73944599|NCT03720938|147421855|OTHER|||||||0.0002535||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.0002535
73944600|NCT03720938|147421855|SUPERIORITY|||||||0.000397||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.000397
73944601|NCT03720938|147421856|SUPERIORITY|||||||0.005||||||The outcome of weight z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z scores.||||0.005
73944602|NCT03720938|147421856|SUPERIORITY|||||||0.002||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z score.||||0.002
73944603|NCT03720938|147421856|SUPERIORITY|||||||0.00386||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality. Adjusted by Satterthwaite's degrees of freedom correction method for cluster effect, and small sample sizes in addition to baseline value and age.||||0.00386
73944604|NCT03720938|147421857|SUPERIORITY|||||||0||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.000
73944605|NCT03720938|147421857|SUPERIORITY|||||||3.06e-06||||||"Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.~Adjusted for cluster effect, and small sample sizes, baseline value and age."|Linear mixed effects model|Satterthwaite's correction method for denominator degrees of freedom.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.00000306
73944606|NCT03720938|147421857|SUPERIORITY|||||||3.67e-06||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.00000367
73944607|NCT03720938|147421858|SUPERIORITY|||||||0||||||The outcome of body mass index z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index z score at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.||||0.000
73944608|NCT03720938|147421858|SUPERIORITY|||||||0.0001402||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.||||0.0001402
73958005|NCT03368001|147451532|OTHER|Posttest ANCOVA controlling for pre-test values||||||0.169|||||||ANCOVA|||||||0.169
73958006|NCT03368001|147451532|OTHER|Followup ANCOVA controlling for pretest values.||||||0.555|||||||ANCOVA|||||||0.555
73958007|NCT01838551|147451551|SUPERIORITY|Under the null hypothesis of at most 20% UFC responders, 90 subjects in the ITT population would provide 90% power, with two-sided type 1 error of 0.05, assuming an observed response of 35%.||||||0.0154||||||One-sided p-value is based on a null hypothesis that true response proportion is ≤ 0.20.|Mixed Models Analysis|The Generalized Linear Model described above was used to generate the p-value.||The least squares mean (LSMEAN) estimate of the UFC response after 6 months of treatment in the Maintenance Phase alongside its 95% Wald CI is presented. Supportive to the 95% CI, the p-value corresponding to the null hypothesis that the response rate is ≤ 20% is presented (1-sided test).||||0.0154
73958008|NCT01875250|147451594|SUPERIORITY|||||||0.74|||||||Wilcoxon rank sum tests|||||||0.74
73958009|NCT05298111|147451683|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73958010|NCT05298111|147451684|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||< 0.001
73944609|NCT03720938|147421858|SUPERIORITY|||||||0.000235||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body index z score.||||0.000235
73944610|NCT03720938|147421859|SUPERIORITY|||||||0.259||||||The outcomes of fat ratio was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the fat ratio at baseline and confounding variable age.|ANCOVA|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.259
73944611|NCT03720938|147421859|SUPERIORITY|||||||0.22||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.220
73944612|NCT03720938|147421859|SUPERIORITY|||||||0.250006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.250006
73944613|NCT03720938|147421860|SUPERIORITY|||||||0||||||The outcome of visual reaction time was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the weight at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.||||0.000
73944614|NCT03720938|147421860|SUPERIORITY|Adjusted for the weight at baseline and confounding variable age.||||||1.196e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of visual reaction time was tested for any difference between groups by linear mixed-effects model analysis.||||0.00001196
73944615|NCT03720938|147421860|SUPERIORITY||||||‬|2.82e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.||||0.0000282‬
73944616|NCT03720938|147421861|SUPERIORITY|||||||0||||||The outcome of visual reaction time of non-dominant hand was tested for any difference between groups.|ANCOVA|Adjusted for the visual reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||0.000
73944617|NCT03720938|147421861|SUPERIORITY|||||||9e-08||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||0.00000009
73944618|NCT03720938|147421861|SUPERIORITY|||||||55||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||000000055
73944619|NCT03720938|147421862|SUPERIORITY|||||||0||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.000
73944620|NCT03720938|147421862|SUPERIORITY|||||||1.633e-05||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by linear mixed-effects analysis.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.00001633
73958011|NCT05298111|147451685|SUPERIORITY||||||<|0.001|||||||Sign test|||||||< 0.001
73958012|NCT05298111|147451686|SUPERIORITY|||||||0.001|||||||Sign test|||||||0.001
73958013|NCT05298111|147451687|SUPERIORITY|||||||0.894|||||||Paired t-test|||||||0.894
73958014|NCT05298111|147451688|SUPERIORITY|||||||0.629|||||||Paired t-test|||||||0.629
73958015|NCT05298111|147451689|SUPERIORITY|||||||0.653|||||||Paired t-test|||||||0.653
73958016|NCT05298111|147451690|SUPERIORITY|||||||0.624|||||||Paired t-test|||||||0.624
73958017|NCT05298111|147451691|SUPERIORITY|||||||0.414|||||||Paired t-test|||||||0.414
73958018|NCT05298111|147451692|SUPERIORITY|||||||0.105|||||||Paired t-test|||||||0.105
73958019|NCT00954707|147451719|SUPERIORITY_OR_OTHER||Rate of TLF at 12-month (%)|6.4|||||TWO_SIDED|95.0|5.5|7.5||||||||7.5|5.5|
73958020|NCT00954707|147451720|SUPERIORITY_OR_OTHER||Rate of device success (%)|98.0|||||TWO_SIDED|95.0|97.4|98.4||||||||98.4|97.4|
73958021|NCT00954707|147451721|SUPERIORITY_OR_OTHER||Rate of lesion success (%)|99.8|||||TWO_SIDED|95.0|99.6|99.9||||||||99.9|99.6|
73958022|NCT00954707|147451722|SUPERIORITY_OR_OTHER||Rate of procedure success (%)|97.7|||||TWO_SIDED|95.0|97.0|98.2||||||||98.2|97.0|
73958023|NCT00954707|147451723|SUPERIORITY_OR_OTHER||Rate of Clinically-driven TLR (%)|4.2|||||TWO_SIDED|95.0|3.45|5.13||||||||5.13|3.45|
73958024|NCT00954707|147451724|SUPERIORITY_OR_OTHER||Rate of Clinically-driven TVR (%)|5.8|||||TWO_SIDED|95.0|4.87|6.81||||||||6.81|4.87|
73958025|NCT00954707|147451725|SUPERIORITY_OR_OTHER||Rate of Target vessel failure (%)|7.92|||||TWO_SIDED|95.0|6.85|9.09||||||||9.09|6.85|
73958026|NCT00954707|147451726|SUPERIORITY_OR_OTHER||Rate of MACE (%)|7.41|||||TWO_SIDED|95.0|6.37|8.55||||||||8.55|6.37|
74031690|NCT03480282|147616673|OTHER|Because the observations were matched by the patient, we used the Wilcoxon signed-rank test, a nonparametric paired test|Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This was a descriptive feasibility study.|This was an exploratory and descriptive study to learn if it was feasible to provide PCPs with their patients (aged 76-89) with information about their 10-year prognosis and engage in shared decision making around stopping screening. We measured among the 90 patients that the 45 PCPs saw whether their intentions to be screened declined after seeing their PCP.|This was a descriptive feasibility study.|||<0.001
74031691|NCT03480282|147616673|OTHER|This was a descriptive feasibility study.|Risk Difference (RD)|0.05|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This was a descriptive feasibility study.|Because the observations were matched by the patient, we used the Wilcoxon signed-rank test, a nonparametric paired test|||<0.001
74031692|NCT01234402|147616692|OTHER||Hazard Ratio (HR)|0.691||||0.1315|TWO_SIDED|95.0|0.429|1.114|||Log Rank|||Kaplan-Meier methodology estimated median PFS||1.114|0.429|0.1315
74031693|NCT01234402|147616692|OTHER||Hazard Ratio (HR)|1.48||||0.0851|TWO_SIDED|95.0|0.938|2.335|||Log Rank|||Kaplan-Meier methodology estimated median PFS||2.335|0.938|0.0851
74031694|NCT01234402|147616693|OTHER||Hazard Ratio (HR)|1.833||||0.0283|TWO_SIDED|95.0|1.06|3.169|||Log Rank|||||3.169|1.060|0.0283
74031695|NCT01234402|147616693|OTHER||Hazard Ratio (HR)|1.468||||0.155|TWO_SIDED|95.0|0.862|2.501|||Log Rank|||||2.501|0.862|0.1550
74031696|NCT01234402|147616694|OTHER|||||||0.6691|||||||Fisher Exact|||||||0.6691
73944621|NCT03720938|147421862|SUPERIORITY|||||||3.67e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.0000367
73944622|NCT03720938|147421863|SUPERIORITY|||||||0.008||||||The outcomes of auditory reaction time of non-dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.008
73944623|NCT03720938|147421863|SUPERIORITY|||||||0.006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.006
73944624|NCT03720938|147421863|SUPERIORITY|||||||0.006602||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.006602
73944625|NCT03720938|147421864|SUPERIORITY|||||||0.615648||||||The outcome of self-perception for sports competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for sports competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.||||0.615648
74031697|NCT01234402|147616694|OTHER|||||||0.1743|||||||Fisher Exact|||||||0.1743
74031698|NCT00385268|147616711|SUPERIORITY||Odds Ratio (OR)|1.68||||0.44|TWO_SIDED|95.0|0.55|5.14|||GEE model of repeated measures|GEE on repeated binary indicators of BE positive / negative test||||5.14|0.55|0.44
74031699|NCT02417233|147616712|OTHER||Odds Ratio (OR)|0.958||||0.848|TWO_SIDED|95.0|0.62|1.49|||Regression, Logistic|||||1.49|0.62|0.848
74031700|NCT02417233|147616712|OTHER||Odds Ratio (OR)|1.492||||0.125|TWO_SIDED|95.0|0.9|2.49|||Regression, Logistic|||||2.49|0.90|0.125
74031701|NCT02417233|147616713|OTHER||Odds Ratio (OR)|0.866||||0.636|TWO_SIDED|96.0|0.48|1.57|||Regression, Logistic|||||1.57|0.48|0.636
73958027|NCT00954707|147451727|SUPERIORITY_OR_OTHER||Rate of protocol defined ST (%)|0.91|||||TWO_SIDED|95.0|0.56|1.38||||||||1.38|0.56|
73958028|NCT00954707|147451728|SUPERIORITY_OR_OTHER||Rate of ARC defined ST (%)|1.12|||||TWO_SIDED|95.0|0.74|1.64||||||||1.64|0.74|
73958029|NCT00954707|147451729|SUPERIORITY_OR_OTHER||Rate of major bleeding complications (%)|3.07|||||TWO_SIDED|95.0|2.4|3.85||||||||3.85|2.40|
73958030|NCT00954707|147451730|SUPERIORITY_OR_OTHER||Rate of cardiac death (%)|0.78|||||TWO_SIDED|95.0|0.46|1.23||||||||1.23|0.46|
73958031|NCT00954707|147451731|SUPERIORITY_OR_OTHER||Rate of non-cardiac death (%)|0.69|||||TWO_SIDED|95.0|0.4|1.12||||||||1.12|0.40|
73958032|NCT00309452|147451761|SUPERIORITY_OR_OTHER|||||||0.018|||||||Chi-squared, Corrected|||Between groups comparison for hospitalization rates, adjusted for pretreatment hospitalization||||0.018
73958033|NCT00309452|147451765|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared, Corrected|||Between groups comparison for vocational engagement, adjusted for pretreatment vocational engagement||||0.002
73958034|NCT00771667|147451772|SUPERIORITY_OR_OTHER|||||||0.005||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.005
73958035|NCT00771667|147451772|SUPERIORITY_OR_OTHER|||||||0.057||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.057
73958036|NCT00771667|147451772|SUPERIORITY_OR_OTHER|||||||0.021||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.021
74031702|NCT02417233|147616713|OTHER||Odds Ratio (OR)|1.401||||0.165|TWO_SIDED|95.0|0.87|2.26|||Regression, Logistic|||||2.26|0.87|0.165
74031703|NCT02417233|147616714|OTHER||Odds Ratio (OR)|1.48||||0.16|TWO_SIDED|95.0|0.86|2.55|||Regression, Logistic|||||2.55|0.86|0.16
74031704|NCT02417233|147616714|OTHER||Odds Ratio (OR)|1.82||||0.03|TWO_SIDED|95.0|1.06|3.14|||Regression, Logistic|||||3.14|1.06|0.03
74031705|NCT02417233|147616715|OTHER||Odds Ratio (OR)|0.27||||0.24|TWO_SIDED|95.0|0.03|2.45|||Regression, Logistic|||||2.45|0.03|0.24
74089245|NCT02697773|147731605|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.0085|TWO_SIDED|95.0|-1.03|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.15|-1.03|0.0085
74089246|NCT02697773|147731605|SUPERIORITY||Least Square Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.22||0.0657|TWO_SIDED|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||0.03|-0.85|0.0657
73869531|NCT01973998|147283160|SUPERIORITY||Hazard Ratio (HR)|1.654|STANDARD_DEVIATION|0.4789||0.1|TWO_SIDED|10.0|1.175|2.133|||Log Rank|||A total of 100 patients is required in a 2 treatment parallel-design study. There is a 70% probability that the study will detect a treatment difference at a 2-sided 10% significance level, if the true hazard ratio is 1.654. This is based on the assumption that the accrual period will be 36 months and the follow up period will be 6 months and the median time to event is 8 months. The total number of events will be 73.||2.133|1.175|0.1
73944626|NCT03720938|147421864|SUPERIORITY|||||||0.608||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.||||0.608
73944627|NCT03720938|147421864|SUPERIORITY|||||||0.60938||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.||||0.60938
73958037|NCT00771667|147451773|SUPERIORITY_OR_OTHER|||||||0.682|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.682
74031706|NCT02417233|147616715|OTHER||Odds Ratio (OR)|2.68||||0.2|TWO_SIDED|95.0|0.59|12.16|||Regression, Logistic|||||12.16|0.59|0.20
74031707|NCT02417233|147616716|OTHER||Odds Ratio (OR)|1.943||||0.093|TWO_SIDED|95.0|0.9|4.21|||Regression, Logistic|||||4.21|0.90|0.093
74031708|NCT02417233|147616716|OTHER||Odds Ratio (OR)|1.764||||0.152|TWO_SIDED|95.0|0.81|3.83|||Regression, Logistic|||||3.83|0.81|0.152
74031709|NCT02262039|147616739|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74031710|NCT02262039|147616740|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
74031711|NCT02262039|147616741|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
74031712|NCT02262039|147616742|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||||||0.52
74031713|NCT02262039|147616743|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
74031714|NCT02262039|147616744|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
74031715|NCT02262039|147616745|SUPERIORITY_OR_OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
73958038|NCT00771667|147451773|SUPERIORITY_OR_OTHER|||||||0.206|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.206
73958039|NCT00771667|147451773|SUPERIORITY_OR_OTHER|||||||0.196|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.196
73958040|NCT00771667|147451774|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.008
73958041|NCT00771667|147451774|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||<0.001
73958042|NCT00771667|147451774|SUPERIORITY_OR_OTHER|||||||0.035|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.035
73958043|NCT00771667|147451775|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||<0.001
73958044|NCT00771667|147451775|SUPERIORITY_OR_OTHER|||||||0.007|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.007
73958045|NCT00771667|147451775|SUPERIORITY_OR_OTHER|||||||0.006|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.006
73958046|NCT00771667|147451776|SUPERIORITY_OR_OTHER|||||||0.074|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.074
73958047|NCT00771667|147451776|SUPERIORITY_OR_OTHER|||||||0.081|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.081
73958048|NCT00771667|147451776|SUPERIORITY_OR_OTHER|||||||0.105|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.105
73958049|NCT00771667|147451777|SUPERIORITY_OR_OTHER|||||||0.029||||||Testing for Week-22 clinical remission was performed if the comparison of 6-mg/kg ustekinumab with placebo was positive for the primary endpoint.|Cochran-Mantel-Haenszel|The CMH test chi-square test, stratified by IV induction dose and clinical remission status at Week 6.||||||0.029
73958050|NCT00771667|147451778|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for induction dose and clinical remission status at Week 6.||||||<0.001
73958051|NCT00286741|147451805|SUPERIORITY_OR_OTHER|||||||0.15|||||||Mixed Models Analysis|||||||0.15
73958052|NCT00286741|147451806|SUPERIORITY_OR_OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
74031716|NCT04174638|147616746|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05. The p value was the value of the total score of the Fluid Control in Hemodialysis Patients Scale.|t-test, 2 sided|||||||<0.001
74031717|NCT04174638|147616747|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||<0.001
73869532|NCT05758402|147283163|OTHER||Rate difference|1.21||||0.544|TWO_SIDED|95.0|-2.71|5.13|||Chi-squared||Rate difference = detection rate of PsA in EARP group - detection rate of PsA in routine practice group|||5.13|-2.71|0.544
73944628|NCT03720938|147421865|SUPERIORITY|||||||0.094||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for physical condition competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.||||0.094
73944629|NCT03720938|147421865|SUPERIORITY|||||||0.085||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.||||0.085
73944630|NCT03720938|147421865|SUPERIORITY|||||||0.08818||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.||||0.08818
73944631|NCT03720938|147421866|SUPERIORITY|||||||0.058102||||||The outcome of self-perception for strength competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for strength competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.058102
73944632|NCT03720938|147421866|SUPERIORITY|||||||0.051||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.051
73869533|NCT05758402|147283164|OTHER|||||||0.256|||||||Chi-squared|||Sensitivity||||0.256
73869534|NCT05758402|147283164|OTHER||||||<|0.001|||||||Chi-squared|||Specificity||||<0.001
73958053|NCT02174562|147451808|SUPERIORITY||Risk Ratio (RR)|1.21||||0.31|TWO_SIDED|95.0|0.84|1.75||0.05 was the a priori level of significance.|Poisson regression with robust SEs||PC-OT is the numerator, Enhanced Usual care is the denominator|Null hypothesis is that the Relative Risk of reduction of HbA1C \>=0.5 for PCOT vs EUC is 1.||1.75|0.84|0.31
73958054|NCT02174562|147451809|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|P-value is for comparison of least squares means for period 2 (months 4-6).||Mixed effects linear regression was used to model the percentage of doses taken each month. Fixed effects were period (1-3 months, 4-6 months, 7-9 months, 10-12 months), randomization group, randomization by period interaction, stratification group, age, and run-in percentage doses taken. The outcome was transformed using the arcsin-square root transformation prior to analysis. A first-order autoregressive correlation structure was assumed.||||0.87
73958055|NCT00864682|147451844|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Kruskal-Wallis|||Hypothesis: Lidocaine / propofol admixture would be superior to lidocaine pretreatment for attenuating propofol-induced injection pain. Sample size calculated to detect a difference of at least 2 VPS points; beta 0.8.||||<0.0001
73958056|NCT00864682|147451845|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.008||95.0|||||Chi-squared|Fisher's exact test after chi-squared||||||<0.008
73958057|NCT00957658|147451847|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 6%|||||<|0.0001|||||||Asymptotic WALD test|||Literature control = 96% with no aseptic loosening, intraop femoral fracture or thigh pain at 2 years||||<.0001
73958058|NCT00957658|147451850|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Improvement from preop to 2 year and preop to 5 year||||<.0001
73958059|NCT00957658|147451851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Compare Pre-op SF-12 Physical Score preop to 2 year and preop to 5 year||||<.0001
73958060|NCT00957658|147451851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Mental Score preop to 2 years||||<.0001
73958061|NCT00957658|147451851|SUPERIORITY_OR_OTHER|||||||0.0004|||||||t-test, 2 sided|||Compare SF-12 Mental Score preop to 5 years||||.0004
73958062|NCT00957658|147451852|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Compare LEAS score preop to 2 years and preop to 5 years||||<.0001
73958063|NCT00957658|147451855|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Compare to historical control (n=94 hips): mean wear 5 years = 0.134 (0.078)||||<.0001
73958064|NCT00957658|147451856|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Sign test|||Compare Wrist DXA T-score preop to 5 years||||.0002
73958065|NCT00094809|147451889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.1|0.37|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group|||0.37|0.10|<0.0001
73958066|NCT00094809|147451890|SUPERIORITY_OR_OTHER||Treatment difference|-18.0|||<|0.0001||95.0|-26.2|-9.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)|||-9.8|-26.2|<0.0001
73958067|NCT00094809|147451891|SUPERIORITY_OR_OTHER||Treatment difference|-12.0||||0.0646||95.0|-23.7|0.5|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)|||0.5|-23.7|0.0646
73958068|NCT00094809|147451892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0384||95.0|0.07|1.0|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of pegfilgrastim group compared to placebo group|||1.00|0.07|0.0384
73958069|NCT00094809|147451893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.5514||95.0|0.26|2.04|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group|||2.04|0.26|0.5514
73958070|NCT00094809|147451895|SUPERIORITY_OR_OTHER||Treatment difference|-3.5||||0.5434||95.0|-14.8|7.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference (pegfilgrastim group - placebo group) in the percentage of participants with a complete or partial response|||7.8|-14.8|0.5434
73958071|NCT00094809|147451896|SUPERIORITY_OR_OTHER||Treatment difference|-12.1||||||95.0|-28.1|4.0|||||Kaplan-Meier estimates of the difference in percent mortality for the pegfilgrastim group - placebo group. Median survival time was not reached for the pegfilgrastim group.|||4.0|-28.1|
73944633|NCT03720938|147421866|SUPERIORITY|||||||0.0534||||||The outcome of self-perception for strength competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.0534
73944634|NCT03720938|147421867|SUPERIORITY|||||||0.638505||||||The outcome of self-perception for body attractiveness was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for body attractiveness at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.638505
73944635|NCT03720938|147421867|SUPERIORITY|||||||0.632||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.632
73944636|NCT03720938|147421867|SUPERIORITY|||||||0.6328||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.63280
73944637|NCT03720938|147421868|SUPERIORITY|||||||0.007061||||||The outcome of self-perception of global physical self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global physical self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.007061
73944638|NCT03720938|147421868|SUPERIORITY|||||||0.005||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.005
73944639|NCT03720938|147421868|SUPERIORITY|||||||0.00603||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.00603
73944640|NCT03720938|147421869|SUPERIORITY|||||||0.002879||||||The outcome of self-perception for global self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.002879
73944641|NCT03720938|147421869|SUPERIORITY|||||||0.002||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.002
73944642|NCT03720938|147421869|SUPERIORITY|||||||0.00238||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.00238
73944643|NCT03720938|147421870|SUPERIORITY|||||||0.194||||||Tested the significance of gender between genders|Wilcoxon (Mann-Whitney)|||"Enjoyment scale of physical activity sports in intervention group between male and female genders"||||0.194
73944644|NCT03720938|147421871|SUPERIORITY|||||||0.809|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the Active video game group for the variable of enjoyment from sports category.||||0.809
73944645|NCT03720938|147421872|SUPERIORITY|||||||0.843|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from balance category.||||0.843
73944646|NCT03720938|147421873|SUPERIORITY|||||||0.247|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from aerobic category.||||0.247
73944647|NCT03720938|147421874|SUPERIORITY|||||||0.543|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from training category.||||0.543
73944648|NCT00571701|147421897|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
73944649|NCT00571701|147421898|SUPERIORITY_OR_OTHER|||||||0.43|||||||Fisher Exact|||||||0.43
73944650|NCT00571701|147421899|SUPERIORITY_OR_OTHER||||||>|0.3||||||Adjusted for multiple comparisons|Fisher Exact|||||||>0.3
73944651|NCT00571701|147421900|SUPERIORITY_OR_OTHER|||||||1||||||Adjusted for multiple comparisons|Fisher Exact|||||||1.00
73944652|NCT00571701|147421901|SUPERIORITY_OR_OTHER||||||>|0.5||||||Adjusted for multiple comparisons|Fisher Exact|||||||> 0.5
73944653|NCT00571701|147421902|SUPERIORITY_OR_OTHER||||||>|0.56|||||||t-test, 2 sided|||||||>0.56
73944654|NCT04766086|147421915|OTHER||Risk difference|0.0||||||95.0|-3.8|3.7||||||||3.7|-3.8|
73944655|NCT04766086|147421916|OTHER||GMR|0.546|||||TWO_SIDED|95.0|0.405|0.736||||||GMR for Anti-PT Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.736|0.405|
73944656|NCT04766086|147421916|OTHER||GMR|0.567|||||TWO_SIDED|95.0|0.455|0.707||||||GMR for Anti-FHA Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.707|0.455|
73958072|NCT00094809|147451897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.23||||0.0457||95.0|0.05|1.09|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group|||1.09|0.05|0.0457
73944657|NCT04766086|147421916|OTHER||GMR|0.588|||||TWO_SIDED|95.0|0.451|0.766||||||GMR for Anti-PRN Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.766|0.451|
73944658|NCT04766086|147421917|OTHER||GMR|0.89|||||TWO_SIDED|95.0|0.38|2.089||||||GMR for serotype Ia: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.089|0.380|
73944659|NCT04766086|147421917|OTHER||GMR|1.149|||||TWO_SIDED|95.0|0.455|2.901||||||GMR for serotype Ib: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.901|0.455|
73944660|NCT04766086|147421917|OTHER||GMR|1.032||||||95.0|0.551|1.931||||||GMR for serotype II: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.931|0.551|
73944661|NCT04766086|147421917|OTHER||GMR|0.635|||||TWO_SIDED|95.0|0.303|1.329||||||GMR for serotype III: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.329|0.303|
73944662|NCT04766086|147421917|OTHER||GMR|1.474|||||TWO_SIDED|95.0|0.842|2.58||||||GMR for serotype IV: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.580|0.842|
73944663|NCT04766086|147421917|OTHER||GMR|0.559|||||TWO_SIDED|95.0|0.232|1.349||||||GMR for serotype V: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.349|0.232|
73944664|NCT03815019|147421918|SUPERIORITY||Odds Ratio, log|7.2218|STANDARD_ERROR_OF_MEAN|13083.0|||TWO_SIDED||||||||Participants in the megestrol group who successfully transitioned to oral feeding.|Analysis conducted using Generalized Linear Mixed Models with a logit link within SAS Proc GLIMMIX to model the binary outcome of transitioned to oral feeding (y/n) defined as at least 90 percent of calories consumed orally. Fixed effects (dummy variables) will be entered for each site as described by McNeish and Stapleton (2016) to account for the clustering of the participants within sites. This will result in essentially, a logistic regression model with appropriate standard errors.||||
73944665|NCT03815019|147421918|SUPERIORITY||Odds Ratio, log|9.1544|STANDARD_ERROR_OF_MEAN|13083.0|||TWO_SIDED||||||||Participants in the placebo group who successfully transitioned to oral feeding.|Analysis conducted using Generalized Linear Mixed Models with a logit link within SAS Proc GLIMMIX to model the binary outcome of transitioned to oral feeding (y/n) defined as at least 90 percent of calories consumed orally. Fixed effects (dummy variables) will be entered for each site as described by McNeish and Stapleton (2016) to account for the clustering of the participants within sites. This will result in essentially, a logistic regression model with appropriate standard errors.||||
73944666|NCT03815019|147421920|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED||||||||Pr(\>F) = 0.7846, Nested model using site as a predictor|||||
73975701|NCT02307682|147496023|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.8|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||2.6|-9.8|
74031718|NCT04174638|147616748|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the knowledge sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.||||<0.001
73944667|NCT03815019|147421921|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED||||||||Pr(\>F) = 0.7025, Nested model using site as a predictor|||||
74031719|NCT04174638|147616748|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the motivation sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.||||<0.001
73944668|NCT03815019|147421922|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED||||||||Pr(\>F) = 0.6764, Nested model using site as a predictor|||||
73944669|NCT03815019|147421923|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED||||||||Pr(\>F) = 0.7649, Nested model using site as a predictor|||||
73944670|NCT03815019|147421924|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||Pr(\>F) = 0.9487, Nested model using site as a predictor|||||
73944671|NCT03815019|147421925|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED||||||||Pr(\>F) = 0.7669, Nested model using site as a predictor|||||
73944672|NCT03815019|147421926|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED||||||||Pr(\>F) = 0.5883, Nested model using site as a predictor|||||
73944673|NCT03815019|147421927|SUPERIORITY||Mean Difference (Final Values)|0.52|||||TWO_SIDED||||||||Pr(\>F) = 0.4749, Nested model using site as a predictor|||||
73944674|NCT03815019|147421928|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED||||||||Pr(\>F) = 0.8781, Nested model using site as a predictor|||||
73944675|NCT01320943|147421929|SUPERIORITY|||||||0.022||||||Log-rank test statistic was used to compare the time to HBsAg loss between the two treatment arms.|Log Rank|||||||0.022
73975702|NCT02307682|147496023|OTHER||Difference in proportions|-4.4|||||TWO_SIDED|95.0|-11.2|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||2.5|-11.2|
74031720|NCT04174638|147616752|SUPERIORITY|||||||0.297||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the physical functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.297
74031721|NCT04174638|147616752|SUPERIORITY|||||||0.742||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||It was calculated for detect of difference in mean the mental functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.742
74031722|NCT04174638|147616752|SUPERIORITY|||||||0.719||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the burden of kidney disease sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.719
74031723|NCT04174638|147616752|SUPERIORITY|||||||0.063||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||It was calculated for detect of difference in mean the symptoms/problems sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.063
73944676|NCT03937219|147421936|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0131|TWO_SIDED|95.0|0.57|0.94|||Log Rank|||||0.94|0.57|0.0131
73944677|NCT00532155|147421938|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.8985|TWO_SIDED|95.0|0.868|1.174|||Stratified log-rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.||||1.174|0.868|0.8985
73944678|NCT00532155|147421939|SUPERIORITY_OR_OTHER_LEGACY||Stratified Hazard ratio|0.819||||0.0035|TWO_SIDED|95.0|0.716|0.937|||Stratified Log-Rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|||0.937|0.716|0.0035
73944679|NCT02134925|147421943|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
73944680|NCT02134925|147421948|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
73944681|NCT01091948|147421958|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Regression, Cox|Intubations accomplished with another device due to difficulty with assigned device and those took \>180 s were considered as failed intubations.||||||0.19
74031724|NCT04174638|147616752|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the effects of kidney disease on daily life sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||<0.001
74031725|NCT02985450|147616772|OTHER||Mean Difference (Final Values)|513.5|STANDARD_DEVIATION|73.6||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Anti-HBs levels difference: high risk obesity group - low risk obesity group NAFLD patients|||||0.02
74031726|NCT00431847|147616782|SUPERIORITY_OR_OTHER||Slope|-0.0323|STANDARD_ERROR_OF_MEAN|0.00619|<|0.0001|TWO_SIDED|95.0|-0.0448|-0.02013|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.02013|-0.0448|<0.0001
74089247|NCT02697773|147731605|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.24||0.0012|TWO_SIDED|95.0|-1.25|-0.31|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.31|-1.25|0.0012
73944682|NCT01091948|147421959|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.89||||0.58|TWO_SIDED|95.0|0.58|1.35|||ANCOVA||The mean intubation difficulty score was tested after logarithmic transformation, and then back transformed for the estimated treatment effect.|||1.35|0.58|0.58
74031727|NCT00431847|147616782|SUPERIORITY_OR_OTHER||Chi Squared|2.65||||0.4492|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4492
74031728|NCT00431847|147616782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.108|STANDARD_ERROR_OF_MEAN|0.2308||0.64|TWO_SIDED|95.0|-0.5621|0.3461|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.|Estimated intercept group difference|A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3461|-0.5621|0.640
74089248|NCT02697773|147731605|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.24||0.0004|TWO_SIDED|95.0|-1.33|-0.38|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.38|-1.33|0.0004
73869535|NCT05758402|147283164|OTHER|||||||0.336|||||||Fisher Exact|||Positive Predictive Value (PPV)||||0.336
73944683|NCT01091948|147421960|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.15|TWO_SIDED|95.0|0.95|1.33|||Cochran-Mantel-Haenszel|||||1.33|0.95|0.15
73944684|NCT01091948|147421961|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.67||||0.57|TWO_SIDED|95.0|0.28|10.2|||Cochran-Mantel-Haenszel|||||10.2|0.28|0.57
73944685|NCT01091948|147421962|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01||||0.79|TWO_SIDED|95.0|0.93|1.09|||Cochran-Mantel-Haenszel|||||1.09|0.93|0.79
73944686|NCT01091948|147421963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.82|TWO_SIDED|95.0|0.45|2.76|||Regression, Logistic|proportional odds logistic regression model||||2.76|0.45|0.82
73958073|NCT00094809|147451898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.3792||95.0|0.32|1.53|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group|||1.53|0.32|0.3792
73958074|NCT01156116|147451938|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.03
73958075|NCT01156116|147451939|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.04
73975703|NCT02307682|147496023|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-15.3|-1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-1.0|-15.3|
73944687|NCT00079001|147421995|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority and futility analysis were conducted for time to first SRE. Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain overall significance level of α = .05 while conducting interim analyses on time to first SRE.|Hazard Ratio (HR)|0.97||||0.385|TWO_SIDED|95.0|0.0|1.174||Because of early termination, conditional power was performed under the alternative hypothesis. This is the probability that zoledronic acid is superior to placebo, given time to first SRE data at interim analysis under alternative hypothesis.|Log Rank||Patients randomly assigned to zoledronic acid were compared with patients assigned to placebo|The null hypothesis was that the hazard ratio is greater than or equal to 1.0 versus the alternative hypothesis that the hazard ratio is less than 0.77. With a target of 470 SREs, log-rank statistic had 88% power to detect a 23% decrease in hazard of SRE (equivalent to an increase in median time to SRE from 30 months to 39 months), assuming a one-sided type I error rate of .05.||1.174|0|0.385
73944688|NCT00079001|147421996|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.29|TWO_SIDED|95.0|0.7|1.12|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group|||1.12|0.70|0.29
73944689|NCT00079001|147421997|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.22|TWO_SIDED|95.0|0.74|1.07|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group|||1.07|0.74|0.22
73944690|NCT00316173|147422000|SUPERIORITY_OR_OTHER||Percentage of participants with CR+PR|30.9||||||95.0|18.7|43.1||||||||43.1|18.7|
73944691|NCT03764072|147422005|SUPERIORITY|||||||0.2107||||||Dose response Model - Linear|Multiple Comparison Procedure-Modelling|||||||0.2107
73869536|NCT05758402|147283164|OTHER|||||||0.49|||||||Chi-squared|||Negative Predictive Value (NPV)||||0.490
73869537|NCT05758402|147283165|OTHER|||||||0.101|||||||Wilcoxon (Mann-Whitney)|||Age characteristics||||0.101
73944692|NCT03764072|147422005|SUPERIORITY|||||||0.0766||||||Dose response Model - Emax|Multiple Comparison Procedure-Modelling|||||||0.0766
73944693|NCT03764072|147422005|SUPERIORITY|||||||0.0989||||||Dose response Model - Logistic|Multiple Comparison Procedure-Modelling|||||||0.0989
73944694|NCT03764072|147422005|SUPERIORITY|||||||0.0927||||||Dose-response Model - Sigmoid Emax|Multiple Comparison Procedure-Modelling|||||||0.0927
73944695|NCT03764072|147422007|SUPERIORITY|||||||0.3162|||||||Cochran-Mantel-Haenszel|||||||0.3162
73944696|NCT03764072|147422007|SUPERIORITY|||||||0.4613|||||||Cochran-Mantel-Haenszel|||||||0.4613
73975704|NCT02307682|147496023|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.9|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.6|-8.9|
73975705|NCT02307682|147496023|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-11.2|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||1.7|-11.2|
73975706|NCT02307682|147496023|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.8|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.7|-10.8|
73975707|NCT02307682|147496023|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-17.3|-3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-3.5|-17.3|
73975708|NCT02307682|147496023|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-2.3|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||11.0|-2.3|
73944697|NCT03764072|147422007|SUPERIORITY|||||||0.4095|||||||Cochran-Mantel-Haenszel|||||||0.4095
73944698|NCT03764072|147422007|SUPERIORITY|||||||0.157|||||||Cochran-Mantel-Haenszel|||||||0.1570
73944699|NCT03764072|147422007|SUPERIORITY|||||||0.9843|||||||Cochran-Mantel-Haenszel|||||||0.9843
73944700|NCT03764072|147422008|SUPERIORITY|||||||0.8714|||||||Cochran-Mantel-Haenszel|||||||0.8714
74031729|NCT00431847|147616782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3299|STANDARD_ERROR_OF_MEAN|0.3372||0.3286|TWO_SIDED|95.0|-0.3334|0.9932|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.9932|-0.3334|0.3286
74031730|NCT00431847|147616782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8591|STANDARD_ERROR_OF_MEAN|0.4716||0.0694|TWO_SIDED|95.0|-0.06841|1.7866|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.7866|-0.06841|0.0694
74031731|NCT00431847|147616783|SUPERIORITY_OR_OTHER||Slope|-0.02332|STANDARD_ERROR_OF_MEAN|0.003777|<|0.0001|TWO_SIDED|95.0|-0.03076|-0.01589|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01589|-0.03076|<0.0001
74031732|NCT00431847|147616783|SUPERIORITY_OR_OTHER||Chi-Squared|2.49||||0.4772|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4772
74031733|NCT00431847|147616783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07724|STANDARD_ERROR_OF_MEAN|0.1503||0.6077|TWO_SIDED|95.0|-0.2184|0.3729|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3729|-0.2184|0.6077
74031734|NCT00431847|147616783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2004|STANDARD_ERROR_OF_MEAN|0.2194||0.3616|TWO_SIDED|95.0|-0.2311|0.6319|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.6319|-0.2311|0.3616
74031735|NCT00431847|147616783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3082|STANDARD_ERROR_OF_MEAN|0.3066||0.3155|TWO_SIDED|95.0|-0.2948|0.9112|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.9112|-0.2948|0.3155
74031736|NCT00431847|147616784|SUPERIORITY_OR_OTHER||Slope|-0.02746|STANDARD_ERROR_OF_MEAN|0.004202|<|0.0001|TWO_SIDED|95.0|-0.03573|-0.01919|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01919|-0.03573|<0.0001
74031737|NCT00431847|147616784|SUPERIORITY_OR_OTHER||Chi-Squared|3.4||||0.3345|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3345
73944701|NCT03764072|147422008|SUPERIORITY|||||||0.5815|||||||Cochran-Mantel-Haenszel|||||||0.5815
74031738|NCT00431847|147616784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0386|STANDARD_ERROR_OF_MEAN|0.1718||0.8223|TWO_SIDED|95.0|-0.2993|0.3765|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3765|-0.2993|0.8223
74031739|NCT00431847|147616784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2919|STANDARD_ERROR_OF_MEAN|0.2506||0.2448|TWO_SIDED|95.0|-0.2009|0.7848|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.7848|-0.2009|0.2448
73869538|NCT05758402|147283166|OTHER|||||||0.836|||||||Chi-squared|||Gender characteristics||||0.836
73869539|NCT05758402|147283167|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Body Mass Index (BMI) characteristics||||0.520
73869540|NCT05758402|147283168|OTHER|||||||0.216|||||||Chi-squared|||Drinking history characteristics||||0.216
73944702|NCT03764072|147422008|SUPERIORITY|||||||0.4308|||||||Cochran-Mantel-Haenszel|||||||0.4308
73944703|NCT03764072|147422008|SUPERIORITY|||||||0.4434|||||||Cochran-Mantel-Haenszel|||||||0.4434
73944704|NCT03764072|147422008|SUPERIORITY|||||||0.855|||||||Cochran-Mantel-Haenszel|||||||0.8550
73869541|NCT05758402|147283168|OTHER|||||||0.719|||||||Chi-squared|||Smoking history characteristics||||0.719
73869542|NCT05758402|147283169|OTHER|||||||0.831|||||||Wilcoxon (Mann-Whitney)|||Duration of Psoriasis (PsO) characteristics||||0.831
73944705|NCT03764072|147422009|SUPERIORITY|||||||0.687|||||||Cochran-Mantel-Haenszel|||||||0.6870
73975709|NCT02307682|147496023|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.8|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||2.6|-9.8|
73944706|NCT03764072|147422009|SUPERIORITY|||||||0.1515|||||||Cochran-Mantel-Haenszel|||||||0.1515
73944707|NCT03764072|147422009|SUPERIORITY|||||||0.603|||||||Cochran-Mantel-Haenszel|||||||0.6030
73944708|NCT03764072|147422009|SUPERIORITY|||||||0.1361|||||||Cochran-Mantel-Haenszel|||||||0.1361
73944709|NCT03764072|147422009|SUPERIORITY|||||||0.564|||||||Cochran-Mantel-Haenszel|||||||0.5640
73944710|NCT03764072|147422010|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.5405|TWO_SIDED|95.0|0.6|2.67|||Regression, Cox|||||2.67|0.60|0.5405
73944711|NCT03764072|147422010|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9011|TWO_SIDED|95.0|0.49|2.27|||Regression, Cox|||||2.27|0.49|0.9011
73944712|NCT03764072|147422010|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9127|TWO_SIDED|95.0|0.48|2.26|||Regression, Cox|||||2.26|0.48|0.9127
73944713|NCT03764072|147422010|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.5619|TWO_SIDED|95.0|0.6|2.56|||Regression, Cox|||||2.56|0.60|0.5619
73869543|NCT05758402|147283170|OTHER|||||||0.274|||||||Fisher Exact|||Family history of psoriasis (PsO) characteristics||||0.274
73869544|NCT05758402|147283170|OTHER|||||||0.272|||||||Fisher Exact|||Family history of psoriatic arthritis (PsA) characteristics||||0.272
73869545|NCT05758402|147283171|OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||Psoriasis Area and Severity Index (PASI) score characteristics||||0.622
73975710|NCT02307682|147496023|OTHER||Difference in proportions|-6.4|||||TWO_SIDED|95.0|-13.2|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.7|-13.2|
73869546|NCT05758402|147283172|OTHER||||||<|0.001|||||||Chi-squared|||Status of hard-to-treat area involvement characteristics||||<0.001
73869547|NCT05758402|147283172|OTHER||||||<|0.001|||||||Chi-squared|||Status of musculoskeletal symptoms characteristics||||<0.001
73869548|NCT05758402|147283173|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of left hand characteristics||||<0.001
73869549|NCT05758402|147283173|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of right hand characteristics||||0.010
73869550|NCT05758402|147283173|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of left foot characteristics||||0.001
73869551|NCT05758402|147283173|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of right foot characteristics||||<0.001
73869552|NCT05758402|147283173|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Total NAPSI score characteristics||||0.001
73869553|NCT05758402|147283174|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||SJC66 total joint count characteristics||||<0.001
73869554|NCT05758402|147283174|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||TJC68 total joint count characteristics||||<0.001
73869555|NCT05758402|147283174|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||SJC66/TJC68 total joint count characteristics||||<0.001
73869556|NCT05758402|147283175|OTHER|||||||0.043|||||||Fisher Exact|||Heart diseases||||0.043
73869557|NCT05758402|147283175|OTHER|||||||1|||||||Fisher Exact|||Stroke||||1.000
73869558|NCT05758402|147283175|OTHER|||||||1|||||||Fisher Exact|||Diabetes||||1.000
73944714|NCT03764072|147422010|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.709|TWO_SIDED|95.0|0.5|2.79|||Regression, Cox|||||2.79|0.50|0.7090
73944715|NCT03764072|147422011|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.5141|TWO_SIDED|95.0|0.61|2.72|||Regression, Cox|||||2.72|0.61|0.5141
73944716|NCT03764072|147422011|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9614|TWO_SIDED|95.0|0.45|2.12|||Regression, Cox|||||2.12|0.45|0.9614
73944717|NCT03764072|147422011|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9756|TWO_SIDED|95.0|0.46|2.14|||Regression, Cox|||||2.14|0.46|0.9756
73944718|NCT03764072|147422011|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.5582|TWO_SIDED|95.0|0.6|2.57|||Regression, Cox|||||2.57|0.60|0.5582
73944719|NCT03764072|147422011|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.7543|TWO_SIDED|95.0|0.49|2.71|||Regression, Cox|||||2.71|0.49|0.7543
73944720|NCT00558064|147422015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|3.98|6.23|||Mixed Models Analysis||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus amlodipine 5 mg monotherapy|||6.23|3.98|<0.0001
73944721|NCT03152084|147422023|OTHER|Within-group change|Least square mean|-5.21||||0.4462|TWO_SIDED|95.0|-19.542|9.12||Start of treatment vs baseline|Mixed Models Analysis|||||9.120|-19.542|0.4462
73944722|NCT03152084|147422024|OTHER|Within-group change|Least square mean|3.69||||0.7842|TWO_SIDED|95.0|-24.817|32.195||End of treatment vs baseline|Mixed Models Analysis|||||32.195|-24.817|0.7842
73944723|NCT03152084|147422024|OTHER|Within-group change|Least square mean|-16.72||||0.0581|TWO_SIDED|95.0|-34.109|0.664||Follow-up vs End of treatment|Regression, Linear|||||0.664|-34.109|0.0581
73944724|NCT03152084|147422025|OTHER|Within-group change|Least square mean|344.85|||<|0.0001|TWO_SIDED|95.0|272.785|416.905||Start of treatment vs baseline|Mixed Models Analysis|||||416.905|272.785|<0.0001
73944725|NCT03152084|147422026|OTHER|Within-group change|Least square mean|311.3|||<|0.0001|TWO_SIDED|95.0|224.528|398.064||End of treatment vs baseline|Mixed Models Analysis|||||398.064|224.528|<0.0001
73944726|NCT03152084|147422027|OTHER|Within-group change|Least square mean|-203.07|||<|0.0001|TWO_SIDED|95.0|-235.983|-170.162||Follow-up vs end of treatment|Regression, Linear|||||-170.162|-235.983|<0.0001
73944727|NCT03152084|147422028|OTHER|Within-group change|Least square mean|-5.2658||||0.0047|TWO_SIDED|95.0|-8.5459|-1.9856||Start of treatment vs baseline|Mixed Models Analysis|||||-1.9856|-8.5459|0.0047
73944728|NCT03152084|147422029|OTHER|Within-group change|Least square mean|-7.0987||||0.0003|TWO_SIDED|95.0|-10.0379|-4.1595||End of treatment vs baseline|Mixed Models Analysis|||||-4.1595|-10.0379|0.0003
73944729|NCT03152084|147422030|OTHER|Within-group change|Least square mean|0.7287||||0.5592|TWO_SIDED|95.0|-1.9894|3.4468||Follow-up vs end of treatment|Regression, Linear|||||3.4468|-1.9894|0.5592
73944730|NCT03152084|147422031|OTHER|Within-group change|Least square mean|0.0315||||0.9288|TWO_SIDED|95.0|-0.7274|0.7904||Start of treatment vs baseline|Mixed Models Analysis|||||0.7904|-0.7274|0.9288
73944731|NCT03152084|147422032|OTHER|Within-group change|Least square mean|-0.4318||||0.1659|TWO_SIDED|95.0|-1.0761|0.2125||End of treatment vs baseline|Mixed Models Analysis|||||0.2125|-1.0761|0.1659
73944732|NCT03152084|147422033|OTHER|Within-group change|Least square mean|0.4755||||0.019|TWO_SIDED|95.0|0.0963|0.8548||Follow-up vs end of treatment|Regression, Linear|||||0.8548|0.0963|0.0190
73944733|NCT03152084|147422034|OTHER|Within-group change|Least square mean|-0.6713||||0.0157|TWO_SIDED|95.0|-1.1914|-0.1511||Start of treatment vs baseline|Mixed Models Analysis|||||-0.1511|-1.1914|0.0157
73944734|NCT03152084|147422035|OTHER|Within-group change|Least square mean|-0.0324||||0.87|TWO_SIDED|95.0|-0.4631|0.3984||End of treatment vs baseline|Mixed Models Analysis|||||0.3984|-0.4631|0.8700
73975711|NCT02307682|147496023|OTHER||Difference in proportions|-12.9|||||TWO_SIDED|95.0|-19.7|-6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-6.6|-19.7|
73975712|NCT02307682|147496024|SUPERIORITY|||||||0.0574||||||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (\<75, ≥75 years) and baseline fluid status)||||||0.0574
73975713|NCT02307682|147496024|SUPERIORITY|||||||0.0012||||||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (\<75, ≥75 years) and baseline fluid status)||||||0.0012
73975714|NCT02307682|147496025|SUPERIORITY||difference in proportions|-6.5||||0.0331|TWO_SIDED|95.0|-13.2|0.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (\<75, \>=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.|||0.3|-13.2|0.0331
74031740|NCT00431847|147616784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4482|STANDARD_ERROR_OF_MEAN|0.3502||0.2014|TWO_SIDED|95.0|-0.2405|1.1369|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.1369|-0.2405|0.2014
74031741|NCT00431847|147616785|SUPERIORITY_OR_OTHER||Slope|-0.0403|STANDARD_ERROR_OF_MEAN|0.007196|<|0.0001|TWO_SIDED|95.0|-0.5446|-0.02613|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-0.02613|-0.5446|<0.0001
74031742|NCT00431847|147616785|SUPERIORITY_OR_OTHER||Chi-Squared|3.19||||0.3631|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3631
74031743|NCT00431847|147616785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1004|STANDARD_ERROR_OF_MEAN|0.2746||0.7148|TWO_SIDED|95.0|-0.6404|0.4396|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.4396|-0.6404|0.7148
74039461|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.1488|TWO_SIDED|95.0|-0.66|0.1|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.10|-0.66|0.1488
73869559|NCT05758402|147283175|OTHER|||||||0.019|||||||Chi-squared|||Hyperlipidemia||||0.019
73869560|NCT05758402|147283175|OTHER|||||||0.073|||||||Chi-squared|||Hypertension||||0.073
73869561|NCT05758402|147283175|OTHER|||||||0.377|||||||Fisher Exact|||Fatty liver||||0.377
73944735|NCT03152084|147422036|OTHER|Within-group change|Least square mean|0.1718||||0.2446|TWO_SIDED|95.0|-0.1358|0.4795||Follow-up vs end of treatment|Regression, Linear|||||0.4795|-0.1358|0.2446
73944736|NCT03152084|147422037|OTHER|Within-group change|Least square mean|-2.1||||0.0023|TWO_SIDED|95.0|-3.299|-0.902||Start of treatment vs baseline|Mixed Models Analysis|||||-0.902|-3.299|0.0023
73944737|NCT03152084|147422037|OTHER|Within-group change|Least square mean|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.929|-1.256||End of treatment vs baseline|Mixed Models Analysis|||||-1.256|-1.929|<0.0001
73944738|NCT03152084|147422037|OTHER|Within-group change|Least square mean|3.88||||0.0002|TWO_SIDED|95.0|2.215|5.553||Follow-up vs end of treatment|Regression, Linear|||||5.553|2.215|0.0002
73944739|NCT03750006|147422088|SUPERIORITY|||||||0.0238||||||Not adjusted for multiple comparisons, P \< 0.05 is considered significant.|t-test, 2 sided|paired T-test||||||0.0238
73944740|NCT03750006|147422089|SUPERIORITY|||||||0.3029|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.3029
73944741|NCT03750006|147422090|SUPERIORITY|||||||0.1713|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.1713
73944742|NCT03750006|147422091|SUPERIORITY|||||||0.1261|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.1261
73944743|NCT03750006|147422092|SUPERIORITY|||||||0.1367|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.1367
73944744|NCT03750006|147422093|SUPERIORITY|||||||0.0111|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.0111
73944745|NCT03750006|147422094|SUPERIORITY|||||||0.0219|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.0219
73944746|NCT03750006|147422095|SUPERIORITY|||||||0.366|||||||t-test, 2 sided|Paired, P \< 0.05 considered significant.||||||0.3660
73944747|NCT03750006|147422098|SUPERIORITY|||||||0.1563|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.1563
73944748|NCT03750006|147422099|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.0110
73869562|NCT01868334|147283177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between Baseline and Year 1 for RCCT study period||||||0.05
73869563|NCT01868334|147283177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||||||Cochran-Armitage trend tests for percentage point difference between Baseline and Year 1 for RCCT study period|Cochran-Armitage trend test|||||||0.05
73944749|NCT03750006|147422100|OTHER|||||||0.3282|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.3282
73944750|NCT03750006|147422101|SUPERIORITY|||||||0.5244|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.5244
73944751|NCT03750006|147422102|SUPERIORITY|||||||0.5718|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.5718
73944752|NCT03881696|147422104|SUPERIORITY||Odds Ratio (OR)|27.853|||<|1e-05|TWO_SIDED|95.0|9.1274|111.2144||The a priori threshold for statistical significance was p \< 0.0001 at the interim analysis OR p \< 0.05 at the final analysis. Gatekeeping and multiple testing strategies were performed to ensure the overall family-wise error rate was ≤ 5%.|Fisher Exact||The odds ratio (OR) represents the odds of success among subjects randomized to omalizumab (numerator) compared to the odds of success among subjects randomized to placebo (denominator, reference group).|The null hypothesis is that the odds of 'success' (defined as consumption of a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1) in omalizumab and placebo for omalizumab arms are equal. Participants missing the blinded OFC to peanut at the end of Stage 1 will be considered a 'failure' for the primary efficacy endpoint.||111.2144|9.1274|<0.00001
73944753|NCT00803101|147422243|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|14.3|||||TWO_SIDED|95.0|2.8|25.8||No P-value is provided as non-inferiority was assessed via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|95% confidence interval|The Newcombe-Wilson score method was used to estimate the 95% CI for the difference (Beriplex-plasma) in the % participants with effective hemostasis||The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.||25.8|2.8|
73944754|NCT00803101|147422244|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|45.3|||||TWO_SIDED|95.0|31.9|56.4||No P-value is provided as non-inferiority was assessed via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|Newcombe-Wilson score method|The Newcombe-Wilson score method was used to estimate the 95% CI for the difference (Beriplex-plasma) in the % pts with rapid decrease of the INR.||The analysis of rapid decrease of the INR was via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with INR ≤ 1.3 at 30 minutes after the end of infusion.||56.4|31.9|
73944755|NCT01782742|147422250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.22|TWO_SIDED|95.0|-0.13|0.03|||t-test, 2 sided|||||0.03|-0.13|0.22
73944756|NCT01782742|147422251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.57|TWO_SIDED|95.0|-4.428|2.428|||t-test, 2 sided|||||2.428|-4.428|0.57
73944757|NCT01782742|147422252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.625||||0.83|TWO_SIDED|95.0|-5.029|6.279|||t-test, 2 sided|||||6.279|-5.029|0.83
73944758|NCT01782742|147422253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.000|0.000|
73944759|NCT01782742|147422254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.375||||0.94|TWO_SIDED|95.0|-9.674|8.924|||t-test, 2 sided|||||8.924|-9.674|0.94
73944760|NCT01782742|147422255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.563||||0.18|TWO_SIDED|95.0|-1.975|11.1|||t-test, 2 sided|||||11.100|-1.975|0.18
73944761|NCT01782742|147422263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.46|TWO_SIDED|95.0|-0.01|0.021|||t-test, 2 sided|||||0.021|-0.010|0.46
73944762|NCT01782742|147422264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided|||||0.040|-0.020|0.53
73944763|NCT02026232|147422269|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73944764|NCT00332332|147422271|SUPERIORITY_OR_OTHER||Percentage of participants|73.5||||||95.0|67.2|79.1||||||||79.1|67.2|
73944765|NCT02790073|147422275|OTHER|Within group comparison vs baseline|||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
73944766|NCT02790073|147422276|OTHER|Within group comparison vs baseline||||||0.015|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.015
73944767|NCT02790073|147422277|OTHER|Within group comparison vs baseline||||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.003
73944768|NCT01392300|147422279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.001
73944769|NCT01392300|147422280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.11||0.003|TWO_SIDED|95.0|0.1|0.5|||ANCOVA|||||0.5|0.1|0.003
73869564|NCT01868334|147283178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between pre and post intervention for Pre-post study period||||||0.05
73869565|NCT01868334|147283178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||||||Cochran-Armitage trend tests for difference between pre and post changes in vaccination rates for Pre-Post study period|Cochran-Armitage trend test|||||||0.05
73944770|NCT01392300|147422281|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.28|||<|0.001|TWO_SIDED|95.0|2.43|7.52|||Regression, Logistic|||||7.52|2.43|<0.001
73944771|NCT01392300|147422282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.001|TWO_SIDED|95.0|1.56|4.63|||Regression, Logistic|||||4.63|1.56|<0.001
73944772|NCT01392300|147422283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.004|TWO_SIDED|95.0|1.33|4.61|||Regression, Logistic|||||4.61|1.33|0.004
73944773|NCT01392300|147422284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.76|5.57|||Regression, Logistic|||||5.57|1.76|<0.001
73944774|NCT01392300|147422285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.021|TWO_SIDED|95.0|1.1|3.34|||Regression, Logistic|||||3.34|1.10|0.021
73944775|NCT01392300|147422286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58||||0.006|TWO_SIDED|95.0|1.32|5.05|||Regression, Logistic|||||5.05|1.32|0.006
73944776|NCT01392300|147422287|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|2.06|6.72|||Regression, Logistic|||||6.72|2.06|<0.001
73944777|NCT01392300|147422288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.002|TWO_SIDED|95.0|1.4|4.46|||Regression, Logistic|||||4.46|1.40|0.002
73944778|NCT01392300|147422289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.102|TWO_SIDED|95.0|0.9|3.22|||Regression, Logistic|||||3.22|0.90|0.102
73944779|NCT01392300|147422290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.67|5.23|||Regression, Logistic|||||5.23|1.67|<0.001
73944780|NCT01392300|147422291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46||||0.002|TWO_SIDED|95.0|1.37|4.41|||Regression, Logistic|||||4.41|1.37|0.002
73975715|NCT02307682|147496025|SUPERIORITY||difference in proportions|-10.5||||0.0013|TWO_SIDED|95.0|-17.1|-3.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (\<75, \>=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.|||-3.5|-17.1|0.0013
73869566|NCT02951429|147283179|SUPERIORITY||Difference of percentage of participants|3.06||||0.6527|TWO_SIDED|95.0|-11.3|17.97|||Chi-squared|||||17.97|-11.30|0.6527
73869567|NCT02951429|147283180|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.7568|TWO_SIDED|95.0|0.67|1.34|||Log Rank|Log-rank test based on the time to the first event to compare the two treatment arms.||||1.34|0.67|0.7568
73869568|NCT02951429|147283181|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.15|||Log Rank|Log-rank test based on the time to the first event to compare the two treatment arms.||||1.15|0.68|0.3760
73869569|NCT02951429|147283182|SUPERIORITY||Difference (95% CI)|2.85||||0.7046|TWO_SIDED|95.0|-12.13|17.84|||Chi-squared|||||17.84|-12.13|0.7046
73869570|NCT02951429|147283183|SUPERIORITY||Difference (95% CI)|0.94||||0.755|TWO_SIDED|95.0|0.62|1.41|||Log Rank|||||1.41|0.62|0.7550
73869571|NCT02951429|147283184|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9174|TWO_SIDED|95.0|0.65|1.61|||Log Rank|||||1.61|0.65|0.9174
73869572|NCT02951429|147283185|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7748|TWO_SIDED|95.0|0.7|1.62|||Log Rank|||||1.62|0.70|0.7748
73869573|NCT02951429|147283186|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.4258|TWO_SIDED|95.0|0.38|1.5|||Log Rank|||||1.50|0.38|0.4258
73944781|NCT01392300|147422292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.069|TWO_SIDED|95.0|0.95|3.69|||Regression, Logistic|||||3.69|0.95|0.069
73944782|NCT01392300|147422293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.034|TWO_SIDED|95.0|1.05|4.0|||Regression, Logistic|||||4.00|1.05|0.034
73944783|NCT01392300|147422294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.169|TWO_SIDED|95.0|0.82|3.16|||Regression, Logistic|||||3.16|0.82|0.169
73944784|NCT01392300|147422295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.92|TWO_SIDED|95.0|0.49|2.18|||Regression, Logistic|||||2.18|0.49|0.920
73944785|NCT01392300|147422296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|1.83|6.91|||Regression, Logistic|||||6.91|1.83|<0.001
73944786|NCT01392300|147422297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.41||||0.007|TWO_SIDED|95.0|1.28|4.56|||Regression, Logistic|||||4.56|1.28|0.007
73944787|NCT01392300|147422298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26||||0.018|TWO_SIDED|95.0|1.15|4.41|||Regression, Logistic|||||4.41|1.15|0.018
73944788|NCT01392300|147422299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
73944789|NCT01392300|147422300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.011|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.011
73944790|NCT01392300|147422301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.032
73944791|NCT01392300|147422302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|<0.001
73944792|NCT01392300|147422303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|<0.001
73944793|NCT01392300|147422304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.029|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.029
73944794|NCT01392300|147422305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
73944795|NCT01392300|147422306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.019|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.019
73944796|NCT01392300|147422307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.137|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.137
73975716|NCT02307682|147496026|OTHER|Treatment difference|Least squares mean difference|0.9|||||TWO_SIDED|95.0|-0.5|2.3||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||2.3|-0.5|
73869574|NCT02951429|147283188|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.3161|TWO_SIDED|95.0|0.31|1.47|||Log Rank|||||1.47|0.31|0.3161
73869575|NCT02951429|147283198|SUPERIORITY||Difference in mean change from baseline|-206.59||||0.5646|TWO_SIDED|95.0|-920.03|506.85|||Linear Mixed Effects Model|||||506.85|-920.03|0.5646
73869576|NCT02951429|147283199|SUPERIORITY||Median Difference (Final Values)|-3.33||||0.5255|TWO_SIDED|95.0|-9.98|2.36|||ANCOVA|Difference in mean change in total score: -4.22||||2.36|-9.98|0.5255
73869577|NCT02951429|147283200|SUPERIORITY||Median Difference (Final Values)|-6.0||||0.4263|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA|Difference in mean change in total score: -5.07||||6.00|-18.00|0.4263
73869578|NCT01620528|147283206|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869579|NCT01620528|147283206|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73944797|NCT01392300|147422308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.013|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.013
73944798|NCT01392300|147422309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.131|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.131
73944799|NCT01392300|147422310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.714|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.714
73944800|NCT01392300|147422311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
73975717|NCT02307682|147496026|OTHER|Treatment difference|Least squares mean difference|0.63|||||TWO_SIDED|95.0|-0.9|2.1||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||2.1|-0.9|
73975718|NCT02307682|147496026|OTHER|Treatment difference|Least squares mean difference|-0.2|||||TWO_SIDED|95.0|-1.8|1.4||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||1.4|-1.8|
73869580|NCT01620528|147283207|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869581|NCT01620528|147283207|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869582|NCT01620528|147283208|SUPERIORITY||Difference in LS Mean Change|-0.65|STANDARD_ERROR_OF_MEAN|0.155|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
73869583|NCT01620528|147283208|SUPERIORITY||Difference in LS Mean Change|-1.3|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
73869584|NCT01620528|147283209|SUPERIORITY||Difference in LS Mean Change|-0.45|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|95.0|||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
73869585|NCT01620528|147283209|SUPERIORITY||Difference in Least Squares Mean|-1.32|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
73869586|NCT01620528|147283210|SUPERIORITY||Difference in LS Mean Change|-0.16|STANDARD_ERROR_OF_MEAN|0.056||0.004|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||0.004
73869587|NCT01620528|147283210|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.057|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||< 0.001
73869588|NCT01620528|147283211|SUPERIORITY||Difference in LS Mean Change|-0.01|STANDARD_ERROR_OF_MEAN|0.051||0.91|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||0.910
73869589|NCT01620528|147283211|SUPERIORITY||Difference in LS Mean Change|-0.26|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||< 0.001
73869590|NCT01620528|147283212|SUPERIORITY||Difference in LS Mean Change|-0.07|STANDARD_ERROR_OF_MEAN|0.056||0.185|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||0.185
73869591|NCT01620528|147283212|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.057|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||< 0.001
73869592|NCT01620528|147283213|SUPERIORITY||Difference in LS Mean Change|-0.09|STANDARD_ERROR_OF_MEAN|0.065||0.144|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.144
73869593|NCT01620528|147283213|SUPERIORITY||Difference in LS Mean Change|-0.2|STANDARD_ERROR_OF_MEAN|0.067||0.003|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.003
73869594|NCT01620528|147283214|SUPERIORITY||Difference in LS Mean Change|0.03|STANDARD_ERROR_OF_MEAN|0.037||0.424|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.424
73869595|NCT01620528|147283214|SUPERIORITY||Difference in LS Mean Change|-0.12|STANDARD_ERROR_OF_MEAN|0.038||0.002|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.002
73869596|NCT01620528|147283215|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869597|NCT01620528|147283215|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869598|NCT01620528|147283216|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869599|NCT01620528|147283216|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869600|NCT01620528|147283217|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869601|NCT01620528|147283217|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869602|NCT01620528|147283218|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73944801|NCT01392300|147422312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.008
73944802|NCT01392300|147422313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.062|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.062
73944803|NCT01392300|147422314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.006
73944804|NCT01392300|147422315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.076
73944805|NCT01392300|147422316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.416|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.416
73944806|NCT01392300|147422317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|<0.001
73944807|NCT01392300|147422318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.175|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.175
73944808|NCT01392300|147422319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.14|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.140
73944809|NCT01392300|147422320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.007
73944810|NCT01392300|147422321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.018|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.018
73944811|NCT01392300|147422322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.105|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.105
73944812|NCT01392300|147422323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.016|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.016
73944813|NCT01392300|147422324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.014|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.014
73944814|NCT01392300|147422325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.22|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.220
73944815|NCT01392300|147422326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.429|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.429
73944816|NCT01392300|147422327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.884|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.884
73975719|NCT02307682|147496026|OTHER|Treatment difference|Least squares mean difference|-0.26|||||TWO_SIDED|95.0|-1.9|1.4||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.4|-1.9|
73944817|NCT01392300|147422328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.844|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.844
73944818|NCT05056870|147422334|SUPERIORITY|Superiority was declared if the upper limit of the 95% confidence interval of was below 0.00 logMAR.|Mean Difference|-0.097|STANDARD_ERROR_OF_MEAN|0.008|||TWO_SIDED|95.0|-0.113|-0.081|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-0.081|-0.113|
73944819|NCT05056870|147422335|SUPERIORITY|Superiority was declared if the lower limit of the 95% confidence interval of was above 0.|Mean Difference|28.0|STANDARD_ERROR_OF_MEAN|2.69|||TWO_SIDED|95.0|22.6|33.3|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||33.3|22.6|
73944820|NCT05056870|147422336|NON_INFERIORITY|Non-Inferiority was declared if the upper limit of the 95% confidence interval of was below 0.05 logMAR.|Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.0061|||TWO_SIDED|95.0|-0.032|-0.008|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-0.008|-0.032|
73975720|NCT02307682|147496026|OTHER|Treatment difference|Least squares mean difference|0.18|||||TWO_SIDED|95.0|-1.6|1.9||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||1.9|-1.6|
73869603|NCT01620528|147283218|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869604|NCT01620528|147283219|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73944821|NCT05056870|147422337|SUPERIORITY|Superiority was declared if the lower limit of the 95% confidence interval of was above 1.|Mean Ratio|2.98|||||TWO_SIDED|95.0|1.73|5.11|||Generalized Linear Mixed Model||Mean Ratio was calculated as Test over Control|||5.11|1.73|
73944822|NCT00676130|147422338|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.7|||<|0.05||95.0|-9.3|15.0|||Chi-squared|||The study was powered to detect a difference in cure rate of 98% in the intervention group vs. 85% in the control group, with 2-sided alpha 0.05. This would yield a number needed to treat of 7.7 for intervention vs. control, and required 144 subjects to achieve 80% power. No data were analyzed until study completion.||15|-9.3|<0.05
73944823|NCT00676130|147422339|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||<|0.05|TWO_SIDED|95.0|-6.5|6.3|||Chi-squared|||We assessed the rate of progression to abscess in the two groups.||6.3|-6.5|<0.05
73944824|NCT01181726|147422342|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.66|||||TWO_SIDED|90.0|94.22|116.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||116.25|94.22|
73944825|NCT01181726|147422343|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||TWO_SIDED|90.0|93.91|101.02|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.02|93.91|
73944826|NCT01181726|147422344|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||TWO_SIDED|90.0|94.05|101.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.30|94.05|
73944827|NCT01181726|147422345|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.35|||||TWO_SIDED|90.0|92.21|107.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.06|92.21|
73944828|NCT01181726|147422346|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.21|||||TWO_SIDED|90.0|91.21|99.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.39|91.21|
73944829|NCT01181726|147422347|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.25|||||TWO_SIDED|90.0|91.18|99.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.51|91.18|
73944830|NCT01181726|147422348|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.33|||||TWO_SIDED|90.0|92.21|107.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.00|92.21|
73944831|NCT01181726|147422349|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.19|||||TWO_SIDED|90.0|91.18|99.38|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.38|91.18|
73944832|NCT01181726|147422350|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.23|||||TWO_SIDED|90.0|91.17|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.47|91.17|
73944833|NCT01181726|147422351|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.92|||||TWO_SIDED|90.0|93.44|102.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.61|93.44|
73944834|NCT01181726|147422352|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.77|||||TWO_SIDED|90.0|93.92|101.78|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.78|93.92|
73958076|NCT01156116|147451940|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.009
73958077|NCT01156116|147451941|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||<0.001
73958078|NCT02057718|147451946|OTHER|Null hypothesis (H0): mean change from baseline to Week 13 is zero. The null hypothesis was tested for each of the 2 PFIC subgroups and overall; the change in the overall population is presented here.|Mean Difference (Net)|-23.304|STANDARD_DEVIATION|160.9748|||TWO_SIDED|95.0|-82.35|35.742||||||This analysis shows the change from baseline to Week 13 in sBA levels for the overall Modified Intent-to-treat Population. Even though a comparison of PFIC1 vs PFIC2 (overall) is noted, the results are the change from baseline for all participants and is not comparative.||35.742|-82.35|
73958079|NCT02503202|147451952|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot B)|0.94|||<|0.001|TWO_SIDED|95.0|0.77|1.14||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.14|0.77|<0.001
73869605|NCT01620528|147283219|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869606|NCT01620528|147283220|SUPERIORITY|||||||0.103|||||||Regression, Logistic|||||||0.103
73944835|NCT01181726|147422353|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.71|||||TWO_SIDED|90.0|94.42|105.3|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||105.30|94.42|
73944836|NCT01181726|147422354|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.19|||||TWO_SIDED|90.0|94.71|103.87|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.87|94.71|
73944837|NCT01181726|147422355|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.83|||||TWO_SIDED|90.0|94.55|101.21|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.21|94.55|
73944838|NCT01181726|147422356|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.01|||||TWO_SIDED|90.0|94.54|101.6|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.60|94.54|
73944839|NCT01181726|147422357|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.87|||||TWO_SIDED|90.0|93.22|102.74|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.74|93.22|
73944840|NCT01181726|147422358|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.96|||||TWO_SIDED|90.0|93.66|102.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.46|93.66|
73944841|NCT01181726|147422359|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.01|||||TWO_SIDED|90.0|94.17|104.11|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.11|94.17|
73944842|NCT01181726|147422360|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.13|||||TWO_SIDED|90.0|94.39|104.1|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.10|94.39|
73944843|NCT01181726|147422361|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.72|||||TWO_SIDED|90.0|94.03|101.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.56|94.03|
73944844|NCT01181726|147422362|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.99|||||TWO_SIDED|90.0|94.11|102.02|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.02|94.11|
73958080|NCT02503202|147451952|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot C)|0.88|||<|0.001|TWO_SIDED|95.0|0.71|1.09||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.09|0.71|<0.001
73944845|NCT01114204|147422366|NON_INFERIORITY|The 95% confidence interval (CI) was calculated using the large sample assumption. The pre-defined non-inferiority margin for testing the difference between treatment groups was -15%.|Treatment Difference|2.58||||0.2833|TWO_SIDED|95.0|-3.89|9.06|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - iron sucrose) was expressed as a percentage.|"Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only.~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information."||9.06|-3.89|0.2833
73944846|NCT00674570|147422372|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.06|=|0.66|TWO_SIDED|95.0|-0.15|0.1|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)||.10|-.15|=.66
73944847|NCT00674570|147422372|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|=|0.41|TWO_SIDED|95.0|-0.17|0.07|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)||.07|-.17|=.41
73944848|NCT00674570|147422372|SUPERIORITY||Median Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06|=|0.43|TWO_SIDED|95.0|-0.07|0.18|||Mixed Models Analysis|||Fear Conditioning End (last trial)||.18|-.07|=.43
73944849|NCT00674570|147422372|SUPERIORITY||Median Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.06|=|0.47|TWO_SIDED|95.0|-0.07|0.17|||Mixed Models Analysis|||Fear Conditioning End (last trial)||.17|-.07|=.47
73944850|NCT00674570|147422372|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.05|=|0.065|TWO_SIDED|95.0|-0.01|0.2|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)||.20|-.01|=.065
73944851|NCT00674570|147422372|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.05|=|0.34|TWO_SIDED|95.0|-0.05|0.15|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)||.15|-.05|=.34
73944852|NCT00674570|147422372|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.05|=|0.003|TWO_SIDED|95.0|0.06|0.26|||Mixed Models Analysis|||Extinction End (last trial)||.26|.06|=.003
73944853|NCT00674570|147422372|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.02|TWO_SIDED|95.0|0.02|0.22|||Mixed Models Analysis|||Extinction End (last trial)||.22|.02|.02
73944854|NCT00674570|147422372|OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.06|=|0.006|TWO_SIDED|95.0|0.05|0.3|||Mixed Models Analysis|||Extinction Retention (first 2 trials) First trials were selected as a test of extinction retention, since repeated presentations of the CS without a UCS were expected to result in additional fear extinction.||.30|.05|=.006
73944855|NCT00674570|147422372|OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.06|=|0.01|TWO_SIDED|95.0|0.04|0.28|||Mixed Models Analysis|||Extinction retention||.28|.04|=.01
73944856|NCT00548132|147422385|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|95.0|0.24|0.9|||Cochran-Mantel-Haenszel|This was calculated based on the assumption that only 85% of eligible patients will consent to the study.|The standard of care is the numerator and the intervention group is the denominator|The null hypothesis is that the Bloostream infection per 1000 catheter days will be similar in both groups. In 2004, 6122 catheter days occurred in by both ICUs. If 15% of these were excluded, then 5203 catheter days/year will be eligible for analysis. The difference in infection rates will reach statistical significance at 12 months with a P-value of 0.04. At 24 months, the P-value will be more significant at 0.006.||0.90|0.24|0.05
73944857|NCT02798211|147422396|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0011|TWO_SIDED|95.0|1.65|7.45|||Regression, Logistic|Statistical analysis (logistic regression) of ACR20 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||7.45|1.65|0.0011
73944858|NCT02798211|147422396|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0961|TWO_SIDED|95.0|0.89|4.15|||Regression, Logistic|Statistical analysis (logistic regression) of ACR20 response in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, 16 weeks||4.15|0.89|0.0961
73944859|NCT02798211|147422397|SUPERIORITY||Odds Ratio (OR)|0.6||||0.333|TWO_SIDED|95.0|0.22|1.68|||Regression, Logistic|Statistical analysis (logistic regression) of presence of dactylitis by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, 16 weeks||1.68|0.22|0.3330
73975721|NCT02307682|147496026|OTHER|Treatment difference|Least squares mean difference|-0.12|||||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.7|-1.9|
73975722|NCT02307682|147496026|OTHER|Treatment difference|Least squares mean difference|0.75|||||TWO_SIDED|95.0|-1.2|2.7||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||2.7|-1.2|
73944860|NCT02798211|147422397|SUPERIORITY||Odds Ratio (OR)|0.4||||0.0841|TWO_SIDED|95.0|0.14|1.13|||Regression, Logistic|Statistical analysis (logistic regression) of presence of dactylitis in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, 16 weeks||1.13|0.14|0.0841
73944861|NCT02798211|147422398|SUPERIORITY||Odds Ratio (OR)|0.52||||0.1618|TWO_SIDED|95.0|0.21|1.3|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||1.30|0.21|0.1618
73944862|NCT02798211|147422398|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0898|TWO_SIDED|95.0|0.19|1.13|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||1.13|0.19|0.0898
73944863|NCT02798211|147422399|SUPERIORITY||Odds Ratio (OR)|0.27||||0.0125|TWO_SIDED|95.0|0.09|0.75|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (LEI) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||0.75|0.09|0.0125
73944864|NCT02798211|147422399|SUPERIORITY||Odds Ratio (OR)|0.25||||0.0086|TWO_SIDED|95.0|0.09|0.7|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||0.70|0.09|0.0086
73975723|NCT02307682|147496026|OTHER|Treatment difference|Least squares mean difference|1.05|||||TWO_SIDED|95.0|-0.9|3.0||Hypothesis testing not pre-specified.|ANCOVA|nalyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||3.0|-0.9|
73869607|NCT01620528|147283220|SUPERIORITY|||||||0.023|||||||Regression, Logistic|||||||0.023
73869608|NCT01620528|147283221|SUPERIORITY|||||||0.031|||||||Regression, Logistic|||||||0.031
73869609|NCT01620528|147283221|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73944865|NCT02798211|147422400|SUPERIORITY||Odds Ratio (OR)|0.35||||0.0338|TWO_SIDED|95.0|0.13|0.92|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC and LEI) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||0.92|0.13|0.0338
73944866|NCT02798211|147422400|SUPERIORITY||Odds Ratio (OR)|0.36||||0.0359|TWO_SIDED|95.0|0.14|0.93|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC and LEI) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||0.93|0.14|0.0359
73944867|NCT02798211|147422401|SUPERIORITY||Odds Ratio, log|6.3||||0.0038|TWO_SIDED|95.0|1.81|21.88|||Regression, Logistic|Statistical analysis (logistic regression) of ACR50 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, week 16||21.88|1.81|0.0038
73944868|NCT02798211|147422401|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0149|TWO_SIDED|95.0|1.36|16.77|||Regression, Logistic|Statistical analysis (logistic regression) of ACR50 response by visit in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.77|1.36|0.0149
73975724|NCT04484623|147496036|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.37|0.73||P-Value presented to 3 decimal places from one-sided stratified Log-Rank test adjusting for the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata.|Log Rank||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata with a covariate of treatment.|||0.73|0.37|<0.001
73975725|NCT04551066|147496065|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2019|TWO_SIDED|95.0|0.81|2.65||calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\^9/Liters versus 50 to \<100 x 10\^9/Liters inclusive|Cochran-Mantel-Haenszel|||||2.65|0.81|0.2019
73869610|NCT01620528|147283222|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73975726|NCT04551066|147496066|SUPERIORITY||Odds Ratio (OR)|0.83||||0.5356|TWO_SIDED|95.0|0.46|1.5||calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\^9/Liters versus 50 to \<100 x 10\^9/Liters inclusive|Cochran-Mantel-Haenszel|||||1.50|0.46|0.5356
73975727|NCT04551066|147496068|SUPERIORITY|||||||0.9354||||||calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\^9/Liters versus 50 to \<100 × 10\^9/Liters inclusive|Log Rank|||||||0.9354
73975728|NCT04551066|147496072|SUPERIORITY|||||||0.0945||||||calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\^9/Liters versus 50 to \<100 × 10\^9/Liters inclusive|Log Rank|||||||0.0945
73975729|NCT03301467|147496097|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.967|TWO_SIDED|95.0|-1.9|1.8|||ANCOVA|||||1.8|-1.9|0.9670
73975730|NCT03301467|147496098|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.3083|TWO_SIDED||||||Van Elteren's Test||"Test for normality showed that mean change and mean percent change were not normally distributed. As per SAP, Van Elteren's test was then applied to test mean percent change.~SAP=Statistical Analysis Protocol"|||||0.3083
73975731|NCT03301467|147496099|SUPERIORITY|||||||0.4591|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi square general association statistic||||||0.4591
73975732|NCT03301467|147496100|SUPERIORITY|||||||0.3106|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi square general association statistic||||||0.3106
73975733|NCT03301467|147496101|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.3368|TWO_SIDED|95.0|-1.5|0.5|||ANCOVA|||||0.5|-1.5|0.3368
73975734|NCT03301467|147496102|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0401|TWO_SIDED|95.0|-1.7|0.0|||ANCOVA|||||-0.0|-1.7|0.0401
73975735|NCT03301467|147496103|SUPERIORITY||Mean Difference (Final Values)|10.84||||0.0534|TWO_SIDED|95.0|-0.16|21.85|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||21.85|-0.16|0.0534
73975736|NCT03301467|147496104|SUPERIORITY||Mean Difference (Final Values)|10.67||||0.0221|TWO_SIDED|95.0|1.56|19.78|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||19.78|1.56|0.0221
73975737|NCT03301467|147496105|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.2638|TWO_SIDED|95.0|-3.08|11.08|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||11.08|-3.08|0.2638
73975738|NCT03301467|147496106|SUPERIORITY||Mean Difference (Final Values)|3.82||||0.2069|TWO_SIDED|95.0|-2.14|9.77|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||9.77|-2.14|0.2069
74039462|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.19||0.2431|TWO_SIDED|95.0|-0.6|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.15|-0.60|0.2431
73869611|NCT01620528|147283222|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869612|NCT01620528|147283223|SUPERIORITY|||||||0.005|||||||Regression, Logistic|||||||0.005
73944869|NCT02798211|147422402|SUPERIORITY||Odds Ratio, log|10.5||||0.0243|TWO_SIDED|95.0|1.36|81.3|||Regression, Logistic|Statistical analysis (logistic regression) of ACR70 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, week 16||81.30|1.36|0.0243
73869613|NCT01620528|147283223|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73944870|NCT02798211|147422402|SUPERIORITY||Odds Ratio (OR)|5.42||||0.112|TWO_SIDED|95.0|0.67|43.64|||Regression, Logistic|Statistical analysis (logistic regression) of ACR70 response by visit in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||43.64|0.67|0.1120
73944871|NCT02798211|147422403|SUPERIORITY||Odds Ratio, log|9.49|||<|0.0001|TWO_SIDED|95.0|3.73|24.16|||Regression, Logistic|Statistical analysis (logistic regression) of PASI75 response by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||24.16|3.73|<0.0001
73975739|NCT03301467|147496107|SUPERIORITY||LSM UPCR Ratio|0.98||||0.9284|TWO_SIDED|95.0|0.67|1.45|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.45|0.67|0.9284
73975740|NCT03301467|147496108|SUPERIORITY||LSM UPCR Ratio|0.86||||0.3778|TWO_SIDED|95.0|0.6|1.21|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.21|0.60|0.3778
73975741|NCT03301467|147496109|SUPERIORITY||LSM MCP-1 Ratio|0.76||||0.081|TWO_SIDED|95.0|0.55|1.04|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.04|0.55|0.0810
73869614|NCT01620528|147283224|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||||||0.008
73944872|NCT02798211|147422403|SUPERIORITY||Odds Ratio (OR)|6.38||||0.0001|TWO_SIDED|95.0|2.51|16.24|||Regression, Logistic|Statistical analysis (logistic regression) of PASI75 response by visit - in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.24|2.51|0.0001
73944873|NCT02798211|147422404|SUPERIORITY||Odds Ratio, log|9.86|||<|0.0001|TWO_SIDED|95.0|3.19|30.45|||Regression, Logistic|Statistical analysis (logistic regression) of PASI90 response in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||30.45|3.19|<.0001
73944874|NCT02798211|147422404|SUPERIORITY||Odds Ratio (OR)|5.21||||0.0043|TWO_SIDED|95.0|1.68|16.21|||Regression, Logistic|Statistical analysis (logistic regression) of PASI90 response in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.21|1.68|0.0043
73944875|NCT02798211|147422405|SUPERIORITY||Odds Ratio, log|14.38||||0.0107|TWO_SIDED|95.0|1.86|111.53|||Regression, Logistic|Statistical analysis (logistic regression) of PASI100 response by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||111.53|1.86|0.0107
73944876|NCT02798211|147422405|SUPERIORITY||Odds Ratio (OR)|9.82||||0.0307|TWO_SIDED|95.0|1.24|77.9|||Regression, Logistic|Statistical analysis (logistic regression) of PAS100 response by in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||77.90|1.24|0.0307
73944877|NCT02798211|147422406|SUPERIORITY||LS Mean of Treatment Difference|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.45|-0.65|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in DAS28-CRP score in treatment period 1 (LOCF)||secukinumab 300mg s.c. injection, 16 weeks|"Standard Error of Treatment Difference~0.203"|-0.65|-1.45|<.0001
73944878|NCT02798211|147422406|SUPERIORITY||LS Means of Treatment Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.24|-0.43|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in DAS28-CRP score in treatment period 1 (LOCF)||secukinumab 150 mg s.c. injection|"LS Mean of Treatment Difference~0.207"|-0.43|-1.24|<.0001
73944879|NCT02798211|147422407|SUPERIORITY||LS Mean of Treatment Difference|-0.21||||0.0107|TWO_SIDED|95.0|-0.37|-0.05|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in HAQ-DI score by in treatment period 1 (LOCF)||secukinumab 300mg s.c. injection|"Standard Error of Treatment Difference~0.081"|-0.05|-0.37|0.0107
73944880|NCT02798211|147422407|SUPERIORITY|secukinumab 150 mg s.c. injection|LS Mean Treatment Difference|-0.13||||0.1109|TWO_SIDED|95.0|-0.3|0.03|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in HAQ-DI score by visit - in treatment period 1 (LOCF)|||"Standard Error of Treatment Difference~-0.083"|0.03|-0.30|0.1109
73944881|NCT01982435|147422415|OTHER|Measures were summarized using means, range and standard error of the means (SEM).|||||<|0.05||||||Two-sided paired t-tests and two-sided unpaired t-tests were respectively conducted to analyze efficacy endpoints between study initiation to end, and between monthly and TAE injection regimens.|t-test, 2 sided|||All analyses were performed with a significance level of 0.05 being assumed for all tests.||||<0.05
73944882|NCT01892345|147422432|OTHER|Treatment Effect|Hazard Ratio (HR)|0.058|||<|0.0001|TWO_SIDED|95.0|0.017|0.197|||Stratified Log-Rank Test||HR based on a stratified Cox proportional hazards model. Confidence interval = Wald confidence interval. HR for eculizumab compared with placebo represented a 94.2% reduction in the risk of relapse, 95% Wald confidence interval (80.3%, 98.3%).|||0.197|0.017|<0.0001
73975742|NCT03301467|147496110|SUPERIORITY||LSM MCP-1 Ratio|0.87||||0.3233|TWO_SIDED|95.0|0.66|1.15|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.15|0.66|0.3233
73944883|NCT01473381|147422471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.0073|TWO_SIDED|95.0|-4.3|-0.84||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.84|-4.30|0.0073
73944884|NCT01473381|147422471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.82||||0.0034|TWO_SIDED|95.0|-4.57|-1.06||P-value was adjusted for multiplicity.|Mixed-effect model|||||-1.06|-4.57|0.0034
73975743|NCT03301467|147496111|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.6025|TWO_SIDED|95.0|-4.6|7.9|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L VAS Score||7.9|-4.6|0.6025
73944885|NCT01473381|147422471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.002|TWO_SIDED|95.0|-4.48|-1.0||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model|||||-1.00|-4.48|0.0020
73975744|NCT03301467|147496111|SUPERIORITY||Mean Difference (Final Values)|-0.0422||||0.1797|TWO_SIDED|95.0|-0.1043|0.0198|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L Index Score||0.0198|-0.1043|0.1797
73975745|NCT03301467|147496112|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.4898|TWO_SIDED|95.0|-7.9|3.8|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L VAS Score||3.8|-7.9|0.4898
73975746|NCT03301467|147496112|SUPERIORITY||Mean Difference (Final Values)|-0.0199||||0.4826|TWO_SIDED|95.0|-0.0757|0.036|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L Index Score||0.0360|-0.0757|0.4826
73975747|NCT03301467|147496113|SUPERIORITY||Mean Difference (Final Values)|0.4019||||0.8161|TWO_SIDED|95.0|-3.0402|3.844|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Physical Component Score||3.8440|-3.0402|0.8161
73975748|NCT03301467|147496113|SUPERIORITY||Mean Difference (Final Values)|0.0052||||0.9982|TWO_SIDED|95.0|-4.5994|4.6099|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Mental Component Score||4.6099|-4.5994|0.9982
73975749|NCT03301467|147496114|SUPERIORITY||Mean Difference (Final Values)|-0.1518||||0.9242|TWO_SIDED|95.0|-3.3192|3.0156|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Physical Component Score||3.0156|-3.3192|0.9242
73975750|NCT03301467|147496114|SUPERIORITY||Mean Difference (Final Values)|1.0283||||0.6534|TWO_SIDED|95.0|-3.4972|5.5537|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Mental Component Score||5.5537|-3.4972|0.6534
73869615|NCT01620528|147283224|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73944886|NCT01473381|147422472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0073|TWO_SIDED|95.0|-0.58|-0.13||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.13|-0.58|0.0073
73944887|NCT01473381|147422472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0097|TWO_SIDED|95.0|-0.55|-0.1||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.10|-0.55|0.0097
73944888|NCT01473381|147422472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0025|TWO_SIDED|95.0|-0.57|-0.12||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model|||||-0.12|-0.57|0.0025
73944889|NCT01473381|147422473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.3563|TWO_SIDED|95.0|-3.9|10.9||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||10.9|-3.9|0.3563
73944890|NCT01473381|147422473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.1611|TWO_SIDED|95.0|-0.4|14.6||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||14.6|-0.4|0.1611
73944891|NCT01473381|147422473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.2672|TWO_SIDED|95.0|-2.7|12.2||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||12.2|-2.7|0.2672
73975751|NCT00979459|147496119|NON_INFERIORITY_OR_EQUIVALENCE|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the AUC(0 to infinity) geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.86|0.99||||||||0.99|0.86|
73975752|NCT00979459|147496120|NON_INFERIORITY_OR_EQUIVALENCE|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the Cmax geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|1.07|||||TWO_SIDED|90.0|0.92|1.24||||||||1.24|0.92|
73869616|NCT01620528|147283225|SUPERIORITY|||||||0.306|||||||Regression, Logistic|||||||0.306
73944892|NCT01889186|147422487|SUPERIORITY||||||<|0.001|||||||Clopper-Pearson exact method|||The ORR for ABT-199 was tested to reject the null hypothesis of ORR = 40%. If the null hypothesis is rejected and the ORR is higher than 40%, then ABT-199 has been shown to have an ORR significantly higher than 40%.The p-value is from the exact binomial distribution comparing ABT-199 ORR to the 40% historical control rate.||||<0.001
73975753|NCT04503681|147496125|SUPERIORITY||Median Difference (Final Values)|0.0||||0.473|TWO_SIDED|95.0|-1.1|1.1|||Wilcoxon (Mann-Whitney)|||||1.1|-1.1|0.473
73975754|NCT04503681|147496126|SUPERIORITY||Median Difference (Final Values)|0.0||||0.338|TWO_SIDED|95.0|-0.8|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|-0.8|0.338
74039463|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2428|TWO_SIDED|95.0|-0.62|0.16|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.16|-0.62|0.2428
73869617|NCT01620528|147283225|SUPERIORITY|||||||0.239|||||||Regression, Logistic|||||||0.239
73944893|NCT01257880|147422501|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test was used to test the null hypothesis that basilar artery vasomotor reactivity was equivalent between the two groups.||||0.39
73944894|NCT03338621|147422528|SUPERIORITY||Cox Proportional Hazard|2.93|||<|0.001|TWO_SIDED|95.0|2.17|3.96|||Log Rank|||||3.96|2.17|<0.001
73944895|NCT00361439|147422543|SUPERIORITY_OR_OTHER||||||<|0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.02
73944896|NCT00361439|147422544|SUPERIORITY_OR_OTHER||||||<|0.023||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.023
73944897|NCT00361439|147422545|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||t-test, 2 sided|||||||<0.002
73944898|NCT00361439|147422546|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.010
73944899|NCT00462280|147422548|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.61
73869618|NCT01620528|147283226|SUPERIORITY|||||||0.855|||||||Regression, Logistic|||||||0.855
73944900|NCT01313286|147422574|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square means|1.08|||||TWO_SIDED|90.0|1.0|1.16|||Mixed Models Analysis|Ratio of test formulation (HCl salt) to reference formulation (free base).||||1.16|1.00|
73944901|NCT01313286|147422575|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square means|1.18|||||TWO_SIDED|90.0|1.07|1.31|||Mixed Models Analysis|Ratio of test formulation (HCl salt) to reference formulation (free base).||||1.31|1.07|
73975755|NCT00712179|147496144|SUPERIORITY_OR_OTHER|||||||0.981|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 15% body weight support will have no effect on EMG pattern.||||0.981
73975756|NCT00712179|147496144|SUPERIORITY_OR_OTHER|||||||0.84|||||||Mixed Models Analysis|||Null Hypothesis: Walking at self selected speed at 0%, 15% and 30% of body weight support will have no effect on EMG pattern||||0.84
73975757|NCT00712179|147496144|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 30% body weight support will have no effect on EMG pattern.||||0.16
73975758|NCT00712179|147496144|SUPERIORITY_OR_OTHER|||||||0.073|||||||Mixed Models Analysis|||Null Hypothesis: Walking at fastest comfortable speeds with different amount of body weight supports will not affect the EMG pattern.||||0.073
73975759|NCT00712179|147496144|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Null Hypothesis: Modification of non-paretic leg loading and movement by the therapist will have no effect on EMG pattern of paretic leg.||||<0.001
73975760|NCT00712179|147496144|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||Null Hypothesis: Modification of paretic leg loading and movement by the therapist will have significant effect on EMG pattern of non-paretic leg.||||0.94
73975761|NCT00945321|147496155|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.93||||0.001|TWO_SIDED|95.0|0.84|1.02||Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels.|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR\>0.80 and GMR≥1.25 vs. GMR\<1.25).||||1.02|0.84|0.001
73975762|NCT00945321|147496155|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.96|1.15||Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR\>0.80 and GMR≥1.25 vs. GMR\<1.25).||||1.15|0.96|<0.001
73975763|NCT00945321|147496155|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.47|||||TWO_SIDED|90.0|1.23|1.76||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.76|1.23|
73975764|NCT00945321|147496155|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.08|||||TWO_SIDED|90.0|0.88|1.32||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.32|0.88|
73975765|NCT00945321|147496155|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.22|||||TWO_SIDED|90.0|1.01|1.46||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.46|1.01|
73975766|NCT00945321|147496155|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.43|||||TWO_SIDED|90.0|1.16|1.75||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.75|1.16|
73975767|NCT00945321|147496156|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.33|||||TWO_SIDED|90.0|1.13|1.56||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.56|1.13|
73869619|NCT01620528|147283226|SUPERIORITY|||||||0.012|||||||Regression, Logistic|||||||0.012
73975768|NCT00945321|147496156|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.86|1.25||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.25|0.86|
73975769|NCT00945321|147496156|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.14|||||TWO_SIDED|90.0|0.96|1.34||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.34|0.96|
73975770|NCT00945321|147496156|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.4|||||TWO_SIDED|90.0|1.16|1.68||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.68|1.16|
73869620|NCT01620528|147283227|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||||||0.010
73975771|NCT00692913|147496161|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.2|||<|0.001||95.0|0.12|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D (25(OH)D) level stratum, age, and region.||||0.35|0.12|<0.001
73975772|NCT00692913|147496162|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-9.7|||<|0.001||95.0|-14.49|-4.93|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-4.93|-14.49|<0.001
73869621|NCT01620528|147283227|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869622|NCT01620528|147283228|SUPERIORITY|||||||0.061|||||||Regression, Logistic|||||||0.061
73869623|NCT01620528|147283228|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73944902|NCT02332590|147422593|SUPERIORITY||LS Mean Difference|-1.077|||<|0.0001|TWO_SIDED|95.0|-1.361|-0.793||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline DAS28-ESR score as a continuous covariate. Hierarchical testing procedure was used to control overall alpha error rate at 0.05 level and handle multiple endpoint analyses. Testing was then performed sequentially in order endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-0.793|-1.361|<0.0001
73944903|NCT02332590|147422594|SUPERIORITY||Odds Ratio (OR)|4.879|||<|0.0001|TWO_SIDED|95.0|2.536|9.389||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||9.389|2.536|<0.0001
73944904|NCT02332590|147422595|SUPERIORITY||Odds Ratio (OR)|1.976||||0.0017|TWO_SIDED|95.0|1.289|3.028||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||3.028|1.289|0.0017
73944905|NCT02332590|147422596|SUPERIORITY||Odds Ratio (OR)|2.286||||0.0036|TWO_SIDED|95.0|1.3|4.02||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||4.020|1.300|0.0036
73944906|NCT02332590|147422597|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0074|TWO_SIDED|95.0|1.168|2.773||Threshold for significance 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||2.773|1.168|0.0074
73944907|NCT02332590|147422598|SUPERIORITY||LS Mean Difference|-0.182||||0.0037|TWO_SIDED|95.0|-0.305|-0.059||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI score as a continuous covariate.||-0.059|-0.305|0.0037
73944908|NCT02332590|147422599|SUPERIORITY||LS Mean Difference|2.65||||0.0006|TWO_SIDED|95.0|1.147|4.153||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline SF-36 PCS score as a continuous covariate.||4.153|1.147|0.0006
73944909|NCT02332590|147422600|SUPERIORITY||LS Mean Difference|1.768||||0.0689|TWO_SIDED|95.0|-0.137|3.674||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline FACIT-F score as a continuous covariate.||3.674|-0.137|0.0689
73944910|NCT05690776|147422723|SUPERIORITY||Mean Difference (Final Values)|12.1|STANDARD_DEVIATION|10.0|<|0.0001|TWO_SIDED|95.0|9.2|15.0|||paired t-test|||||15.0|9.2|<0.0001
73975773|NCT00692913|147496163|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|-7.07|||<|0.001||95.0|-10.95|-3.2|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-3.20|-10.95|<0.001
73869624|NCT01620528|147283229|SUPERIORITY|||||||0.126|||||||Regression, Logistic|||||||0.126
73944911|NCT05690776|147422724|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.133|<|0.0001|TWO_SIDED|95.0|0.053|0.128|||paired t-test|||||0.128|0.053|<0.0001
73944912|NCT05690776|147422726|SUPERIORITY||Mean Difference (Final Values)|20.7|STANDARD_DEVIATION|13.2|<|0.0001|TWO_SIDED|95.0|16.9|24.5|||paired t-test|||||24.5|16.9|<0.0001
73944913|NCT01061333|147422730|SUPERIORITY_OR_OTHER||Difference in LS mean|16.22|||<|0.0001|TWO_SIDED|90.0|10.74|21.69||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||21.69|10.74|<0.0001
73944914|NCT01061333|147422730|SUPERIORITY_OR_OTHER||Difference in LS Mean|15.51||||0.0001|TWO_SIDED|90.0|10.0|21.02||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||21.02|10.00|0.0001
73975774|NCT00692913|147496164|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.21|||<|0.001||95.0|0.13|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||0.35|0.13|<0.001
73975775|NCT00692913|147496165|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.01||||0.047||95.0|0.01|2.0|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Lumbar Spine.|||2.00|0.01|0.047
73975776|NCT00692913|147496165|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.82||||0.035||95.0|0.06|1.58|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Total Hip.|||1.58|0.06|0.035
73869625|NCT01620528|147283229|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
73869626|NCT01620528|147283230|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.65|-0.34|||mixed-effects model|||||-0.34|-0.65|< 0.001
73944915|NCT01061333|147422730|SUPERIORITY_OR_OTHER||Difference in LS Mean|8.49||||0.0432|TWO_SIDED|90.0|1.78|15.2||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||15.20|1.78|0.0432
73944916|NCT01061333|147422731|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.27||||0.043|TWO_SIDED|90.0|1.05|1.54||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.54|1.05|0.0430
73944917|NCT01061333|147422731|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.41||||0.01|TWO_SIDED|90.0|1.15|1.72||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.72|1.15|0.0100
73944918|NCT01061333|147422731|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.3||||0.086|TWO_SIDED|90.0|1.01|1.67||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.67|1.01|0.0860
73944919|NCT01061333|147422732|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|TWO_SIDED|90.0|0.5|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.70|0.50|<0.0001
73944920|NCT01061333|147422732|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|TWO_SIDED|90.0|0.49|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.70|0.49|<0.0001
73944921|NCT01061333|147422732|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.87||||0.2679|TWO_SIDED|90.0|0.69|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.08|0.69|0.2679
73944922|NCT01061333|147422733|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.9||||0.7622|TWO_SIDED|90.0|0.51|1.59||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.59|0.51|0.7622
73944923|NCT01061333|147422733|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.94||||0.8468|TWO_SIDED|90.0|0.53|1.65||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated on log scale||||1.65|0.53|0.8468
73944924|NCT01061333|147422733|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.91||||0.614|TWO_SIDED|90.0|0.65|1.26||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.26|0.65|0.6140
73944925|NCT01061333|147422734|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.67||||0.0006|TWO_SIDED|90.0|0.57|0.8||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.80|0.57|0.0006
73944926|NCT01061333|147422734|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.79||||0.0291|TWO_SIDED|90.0|0.67|0.94||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.94|0.67|0.0291
73944927|NCT01061333|147422734|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.92||||0.3738|TWO_SIDED|90.0|0.77|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.08|0.77|0.3738
73944928|NCT01061333|147422735|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.03||||0.7501||90.0|0.88|1.2||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.20|0.88|0.7501
73944929|NCT01061333|147422735|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.01||||0.941|TWO_SIDED|90.0|0.81|1.25||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.25|0.81|0.9410
73944930|NCT01061333|147422735|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|0.89||||0.1165|TWO_SIDED|90.0|0.79|1.01||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.01|0.79|0.1165
73944931|NCT01061333|147422736|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.03||||0.8616|TWO_SIDED|90.0|0.76|1.41||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.41|0.76|0.8616
73944932|NCT01061333|147422736|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.06||||0.7512|TWO_SIDED|90.0|0.77|1.45||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.45|0.77|0.7512
73944933|NCT01061333|147422736|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|0.99||||0.9723|TWO_SIDED|90.0|0.72|1.37||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.37|0.72|0.9723
73944934|NCT01061333|147422737|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.3||||0.1983|TWO_SIDED|90.0|0.92|1.82||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.82|0.92|0.1983
73944935|NCT01061333|147422737|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.57||||0.0872|TWO_SIDED|90.0|1.02|2.42||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||2.42|1.02|0.0872
73944936|NCT01061333|147422737|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.22||||0.2499|TWO_SIDED|90.0|0.91|1.62||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.62|0.91|0.2499
73944937|NCT00141739|147422747|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||0.001
73944938|NCT02287584|147422760|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.04||0.007|TWO_SIDED|95.0|-9.6|-1.6||adjusted p value, Hochberg procedure|Mixed Models Analysis|||Using Mixed Model for Repeated Measures||-1.6|-9.6|0.007
73944939|NCT02287584|147422760|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-14.4|-6.4||adjusted p-value, Hochberg procedure|Mixed Models Analysis|||||-6.4|-14.4|<0.001
73944940|NCT02884414|147422764|OTHER|Paired Student's t-test.||||||0.44|||||||t-test, 2 sided|||||||0.44
73944941|NCT04026165|147422788|SUPERIORITY||Difference in Adjusted Mean|1.2|STANDARD_ERROR_OF_MEAN|0.82||0.1439|TWO_SIDED|95.0|-0.41|2.81|||Random Slope Model|||Estimates were from a random slope model with change in eGFRcr from treatment-specific Baselines at Weeks 4, 8, 12, 24, 36, 48, 60, 72, and 84 as outcome, including terms for treatment-specific Baseline eGFRcr, pre-run-in urine albumin to creatinine ratio (UACR) category (\< 1500 mg/g vs. \>= 1500 mg/g), concomitant use of sodium-glucose co-transporter-2 (SGLT-2) inhibitors at Randomization, treatment group, week, and treatment-by-week interaction, where week has a random effect.||2.81|-0.41|0.1439
73944942|NCT04026165|147422789|SUPERIORITY||Difference in Percentage|0.1||||0.8353|TWO_SIDED|95.0|-10.9|11.4||p-value was based on Cochran-Mantel-Haenszel test stratified by Randomization stratification factors. Randomization stratification factors= pre-run-in eGFRcr stratum, pre-run-in UACR category and concomitant use of SGLT-2 inhibitors at Randomization.|Cochran-Mantel-Haenszel||95% exact CI based on the Santner-Snell method was presented for the difference in proportions between SEL and placebo arms.|||11.4|-10.9|0.8353
73944943|NCT04026165|147422790|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.201|TWO_SIDED|95.0|0.81|2.72|||Stratified Log-Rank|P-value was calculated using a stratified log-rank test, stratified by randomization stratification factors.|Hazard ratio and 95% CI were estimated using a stratified Cox proportional hazard model, stratified by randomization stratification factors and were reported only for outcomes with more than 10 events, and have at least 1 event in each treatment arm.|||2.72|0.81|0.2010
73944944|NCT04026165|147422792|SUPERIORITY||Difference in Adjusted Mean|0.44|STANDARD_ERROR_OF_MEAN|0.72||0.5399|TWO_SIDED|95.0|-0.97|1.86|||Random Slope Model|||Estimates were from a random slope model with change in eGFRcys from pre-run-in Baseline at Weeks 4, 8, 12, 24, 36, 48, 60, 72, and 84 as outcome, including terms for pre-run-in Baseline eGFRcys, pre-run-in UACR category (\< 1500 mg/g vs. \>= 1500 mg/g), concomitant use of SGLT-2 inhibitors at Randomization, treatment group, week, and treatment-by-week interaction, where week has a random effect.||1.86|-0.97|0.5399
73944945|NCT04710927|147422816|OTHER||Odds Ratio (OR)|0.7|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73944946|NCT04710927|147422816|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73944947|NCT02007434|147422837|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.24|STANDARD_ERROR_OF_MEAN|0.59||0.6803|TWO_SIDED|95.0|-0.93|1.41|||ANCOVA||Paradigm 1 - Paradigm 2|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.41|-0.93|0.6803
73944948|NCT02007434|147422837|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.39|STANDARD_ERROR_OF_MEAN|0.61||0.5206|TWO_SIDED|95.0|-0.82|1.6|||ANCOVA||Paradigm 1 - Paradigm 3|Day 0, 1 Minute. Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.60|-0.82|0.5206
73944949|NCT02007434|147422837|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.606|TWO_SIDED|395.0|-0.86|1.46|||ANCOVA||Paradigm 1 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.46|-0.86|0.6060
73944950|NCT02007434|147422837|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.15|STANDARD_ERROR_OF_MEAN|0.56||0.7935|TWO_SIDED|95.0|-0.98|1.27|||ANCOVA||Paradigm 2 - Paradigm 3|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.27|-0.98|0.7935
73944951|NCT02007434|147422837|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.06|STANDARD_ERROR_OF_MEAN|0.55||0.914|TWO_SIDED|95.0|-1.03|1.15|||ANCOVA||Paradigm 2 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.15|-1.03|0.9140
73944952|NCT02007434|147422837|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.56||0.8754|TWO_SIDED|95.0|-1.21|1.04|||ANCOVA||Paradigm 3 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.04|-1.21|0.8754
73944953|NCT01287611|147422848|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.0001|||||||Chi-squared|||||||0.0001
73975777|NCT00692913|147496166|SUPERIORITY_OR_OTHER_LEGACY||Difference of falls (falls/patient-year)|0.03|STANDARD_ERROR_OF_MEAN|0.08||0.675||95.0|-0.12|0.19|||Zero-Inflated Poisson Regression|Adjusted by the terms for treatment, baseline 25(OH) D level stratum, age, and region and offset variable of log (total patient-years in the study).||||0.19|-0.12|0.675
73975778|NCT00692913|147496167|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-8.35||||0.001||95.0|-13.19|-3.54|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-3.54|-13.19|0.001
73975779|NCT00692913|147496168|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-8.07|||<|0.001||95.0|-11.94|-4.21|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-4.21|-11.94|<0.001
73975780|NCT01128595|147496197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.515|||||TWO_SIDED|95.0|0.33|0.701||||||||0.701|0.330|
73975781|NCT01128595|147496197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.543|||||TWO_SIDED|95.0|0.355|0.73||||||||0.730|0.355|
73975782|NCT01128595|147496197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|||||TWO_SIDED|95.0|0.001|0.388||||||||0.388|0.001|
73975783|NCT01128595|147496197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|||||TWO_SIDED|95.0|-0.198|0.143||||||||0.143|-0.198|
73975784|NCT01128595|147496197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.14|0.501||||||||0.501|0.140|
73975785|NCT01128595|147496200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|||||TWO_SIDED|95.0|0.332|0.636||||||||0.636|0.332|
73975786|NCT01128595|147496200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|||||TWO_SIDED|95.0|0.33|0.638||||||||0.638|0.330|
73975787|NCT01128595|147496200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|||||TWO_SIDED|95.0|0.009|0.327||||||||0.327|0.009|
73975788|NCT01128595|147496200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.14|0.14||||||||0.140|-0.140|
73975789|NCT01128595|147496200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.316|||||TWO_SIDED|95.0|0.168|0.464||||||||0.464|0.168|
73975790|NCT01128595|147496201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|||||TWO_SIDED|95.0|0.031|0.393||||||||0.393|0.031|
73975791|NCT01128595|147496201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.341|||||TWO_SIDED|95.0|0.147|0.536||||||||0.536|0.147|
73975792|NCT01128595|147496201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.477|||||TWO_SIDED|95.0|0.282|0.672||||||||0.672|0.282|
73975793|NCT01128595|147496201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|||||TWO_SIDED|95.0|0.066|0.463||||||||0.463|0.066|
73944954|NCT01287611|147422849|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.001|||||||t-test, 2 sided|||||||0.001
73944955|NCT04074590|147422859|OTHER|A Bayesian analysis of clinical remission rate (based on total Mayo score) with binomial distribution, was modelled with baseline total Mayo score and treatment group as explanatory variables, to compare the remission rates between LYS006 and placebo groups.|Posterior estimate treatment difference|-3.29||||0.314|TWO_SIDED|90.0|-18.02|13.23||Posterior probability that clinical remission rate is better than placebo: Prob (diff\>0)|Bayesian analysis||90% credible intervals are reported on the treatment difference|||13.23|-18.02|0.314
73944956|NCT04074590|147422859|OTHER|A Bayesian analysis of clinical remission rate (based on total Mayo score) with binomial distribution, was modelled with baseline total Mayo score and treatment group as explanatory variables, to compare the remission rates between LYS006 and placebo groups.|Posterior estimate treatment difference|-3.29||||0.037|TWO_SIDED|90.0|-18.02|13.23||Posterior probability that clinical remission rate \>15% over placebo: Prob (diff\>0.15)|Bayesian analysis||90% credible intervals are reported on the treatment difference|||13.23|-18.02|0.037
73944957|NCT03299686|147422876|SUPERIORITY||Mean Difference (Net)|0.027|STANDARD_DEVIATION|0.043||0.7374|TWO_SIDED|80.0|-0.029|0.082||Probability CJM112 better than placebo|Bayesian linear repeated measures model||||Lower limit and upper limit represents the Credibility Interval from the Bayesian analysis.|0.082|-0.029|0.7374
73944958|NCT03299686|147422877|SUPERIORITY||Mean Difference (Net)|0.913|STANDARD_ERROR_OF_MEAN|1.434||0.263|TWO_SIDED|80.0|-0.939|2.766||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||2.766|-0.939|0.263
73944959|NCT03299686|147422878|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.061|TWO_SIDED|80.0|-0.41|-0.04||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||-0.04|-0.41|0.061
73944960|NCT03299686|147422879|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.04|TWO_SIDED|80.0|-0.4|-0.06||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||-0.06|-0.40|0.040
73944961|NCT02709005|147422882|SUPERIORITY||Risk Difference (RD)|-0.08||||0.42|TWO_SIDED|95.0|-0.26|0.08||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction. The statistical informational goal for the study of 90 participants eligible in the modified Intent-to-Treat (mITT) efficacy population was an ad-hoc sample size determined by logistical considerations, as there was insufficient pilot data upon which to base more formal sample size calculations.||0.08|-0.26|0.420
73944962|NCT02709005|147422883|SUPERIORITY||Risk Difference (RD)|0.14||||0.2|TWO_SIDED|95.0|-0.06|0.33||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants Experiencing Solicited Events between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with solicited urogenital AEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.33|-0.06|0.200
73944963|NCT02709005|147422884|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|||||No SAEs were reported; therefore the Fisher's Exact Test was not performed.||||The null hypothesis was that there was no difference in participants with related SAEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||||
73944964|NCT02709005|147422885|SUPERIORITY||Risk Difference (RD)|0.0|||>|0.999|TWO_SIDED|95.0|-0.13|0.08||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.08|-0.13|>0.999
73975794|NCT01128595|147496201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|||||TWO_SIDED|95.0|-0.072|0.343||||||||0.343|-0.072|
73975795|NCT01128595|147496202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|||||TWO_SIDED|95.0|-0.037|0.215||||||||0.215|-0.037|
73975796|NCT01128595|147496202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|||||TWO_SIDED|95.0|0.101|0.371||||||||0.371|0.101|
73975797|NCT01128595|147496202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|||||TWO_SIDED|95.0|0.127|0.398||||||||0.398|0.127|
73975798|NCT01128595|147496202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|||||TWO_SIDED|95.0|0.036|0.312||||||||0.312|0.036|
73869627|NCT01620528|147283230|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.81|-0.49|||mixed-effects model|||||-0.49|-0.81|< 0.001
73975799|NCT01128595|147496202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|||||TWO_SIDED|95.0|-0.118|0.171||||||||0.171|-0.118|
73975800|NCT00372775|147496210|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|1.6|||||TWO_SIDED|95.0|0.0|8.8|||||Two-Sided Confidence Interval (CI) from Exact Method using the F Distribution|||8.8|0.0|
73975801|NCT00372775|147496212|SUPERIORITY_OR_OTHER||ORR (percent)|4.3|||||TWO_SIDED|95.0|0.1|21.9|||||Two-Sided CI from Exact Method using the F Distribution|||21.9|0.1|
73975802|NCT00372775|147496215|SUPERIORITY_OR_OTHER||Percentage|23.4|||||TWO_SIDED|95.0|14.0|34.3|||||Probability of survival along with the corresponding 2-sided confidence interval for the log \[-log(one-year survival rate)\] calculated using a normal approximation and then back transformed to give a confidence interval for the one-year survival|||34.3|14.0|
73975803|NCT02568215|147496240|OTHER||Prevention Efficacy (PE)|8.8||||0.7|TWO_SIDED|95.0|-45.1|42.6||The threshold for statistical significance was p = 0.05.|wald|||The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.||42.6|-45.1|0.70
73869628|NCT01620528|147283231|SUPERIORITY||LS Mean of Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|97.5|-0.79|-0.49|||mixed-effects model|||||-0.49|-0.79|< 0.001
73869629|NCT01620528|147283231|SUPERIORITY||LS Mean of Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-1.51|-1.2|||mixed-effects model|||||-1.20|-1.51|< 0.001
73869630|NCT01620528|147283232|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.83|-0.53|||mixed-effects model|||||-0.53|-0.83|< 0.001
73869631|NCT01620528|147283232|SUPERIORITY||LS Mean of Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|97.5|-1.54|-1.23|||mixed-effects model|||||-1.23|-1.54|< 0.001
73869632|NCT01620528|147283233|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.81|-0.49|||mixed-effects model|||||-0.49|-0.81|< 0.001
73869633|NCT01620528|147283233|SUPERIORITY||LS Mean of Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|97.5|-1.49|-1.16|||mixed-effects model|||||-1.16|-1.49|< 0.001
73869634|NCT01620528|147283234|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.75|-0.43|||mixed-effects model|||||-0.43|-0.75|< 0.001
73869635|NCT01620528|147283234|SUPERIORITY||LS Mean of Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|97.5|-1.58|-1.25|||mixed-effects model|||||-1.25|-1.58|< 0.001
73869636|NCT01620528|147283235|SUPERIORITY||LS Mean of Difference|-24.07|STANDARD_ERROR_OF_MEAN|3.288|<|0.001|TWO_SIDED|97.5|-31.45|-16.69|||mixed-effects model|||||-16.69|-31.45|< 0.001
73869637|NCT01620528|147283235|SUPERIORITY||LS Mean of Difference|-31.01|STANDARD_ERROR_OF_MEAN|3.299|<|0.001|TWO_SIDED|97.5|-38.41|-23.6|||mixed-effects model|||||-23.60|-38.41|< 0.001
73944965|NCT02709005|147422886|SUPERIORITY||Risk Difference (RD)|-0.09||||0.035|TWO_SIDED|95.0|-0.24|-0.01||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||-0.01|-0.24|0.035
73944966|NCT02709005|147422891|SUPERIORITY||Risk Difference (RD)|0.0|||>|0.999|TWO_SIDED|95.0|-0.18|0.14||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.14|-0.18|>0.999
73944967|NCT00691132|147422895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.023|TWO_SIDED|95.0|-13.8|-1.2|||Mixed Models Analysis|||% difference between Placebo and PEITC periods in the ratio of \[pyridine-D4\]Hydroxy acid : \[pyridine-D4\] total NNAL||-1.2|-13.8|0.023
73944968|NCT00691132|147422896|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANOVA|||Total ITC||||0.005
73944969|NCT00691132|147422898|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||ANOVA|||Total ITC||||0.017
73975804|NCT02568215|147496240|OTHER||Prevention Efficacy (PE)|-9.3|||||TWO_SIDED|95.0|-85.3|35.5||||||A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.||35.5|-85.3|
73975805|NCT02568215|147496240|OTHER||Prevention Efficacy (PE)|27.0|||||TWO_SIDED|95.0|-30.7|59.3||||||A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.||59.3|-30.7|
73869638|NCT01620528|147283236|SUPERIORITY||LS Mean of Difference|-30.79|STANDARD_ERROR_OF_MEAN|3.107||-30.79|TWO_SIDED|97.5|-37.77|-23.82|||mixed-effects model|||||-23.82|-37.77|-30.79
73869639|NCT01620528|147283236|SUPERIORITY||LS Mean of Difference|-63.78|STANDARD_ERROR_OF_MEAN|3.148|<|0.001|TWO_SIDED|97.5|-70.85|-56.71|||mixed-effects model|||||-56.71|-70.85|< 0.001
73869640|NCT01620528|147283237|SUPERIORITY||LS Mean of Difference|-32.21|STANDARD_ERROR_OF_MEAN|3.177|<|0.001|TWO_SIDED|97.5|-39.35|-25.08|||mixed-effects model|||||-25.08|-39.35|< 0.001
73869641|NCT01620528|147283237|SUPERIORITY||LS Mean of Difference|-64.94|STANDARD_ERROR_OF_MEAN|3.23|<|0.001|TWO_SIDED|97.5|-72.19|-57.68|||mixed-effects model|||||-57.68|-72.19|< 0.001
73869642|NCT01620528|147283238|SUPERIORITY||LS Mean of Difference|-29.94|STANDARD_ERROR_OF_MEAN|3.272|<|0.001|TWO_SIDED|97.5|-37.28|-22.59|||mixed-effects model|||||-22.59|-37.28|< 0.001
73869643|NCT01620528|147283238|SUPERIORITY||LS Mean of Difference|-61.9|STANDARD_ERROR_OF_MEAN|3.356|<|0.001|TWO_SIDED|97.5|-69.44|-54.36|||mixed-effects model|||||-54.36|-69.44|< 0.001
73869644|NCT01620528|147283239|SUPERIORITY||LS Mean of Difference|-28.63|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|97.5|-35.96|-21.31|||mixed-effects model|||||-21.31|-35.96|< 0.001
73869645|NCT01620528|147283239|SUPERIORITY||LS Mean of Difference|-66.5|STANDARD_ERROR_OF_MEAN|3.321|<|0.001|TWO_SIDED|97.5|-73.95|-59.04|||mixed-effects model|||||-59.04|-73.95|< 0.001
73869646|NCT01620528|147283240|SUPERIORITY||LS Mean of Difference|-21.39|STANDARD_ERROR_OF_MEAN|3.479|<|0.001|TWO_SIDED|97.5|-29.2|-13.57|||mixed-effects model|||||-13.57|-29.20|< 0.001
73869647|NCT01620528|147283240|SUPERIORITY||LS Mean of Difference|-60.78|STANDARD_ERROR_OF_MEAN|3.557|<|0.001|TWO_SIDED|97.5|-68.77|-52.79|||mixed-effects model|||||-52.79|-68.77|< 0.001
73869648|NCT01620528|147283241|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.036||0.111|TWO_SIDED|97.5|-0.14|0.02|||mixed-effects model|||||0.02|-0.14|0.111
73869649|NCT01620528|147283241|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.036||0.008|TWO_SIDED|97.5|-0.18|-0.01|||mixed-effects model|||||-0.01|-0.18|0.008
73869650|NCT01620528|147283242|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.045||0.092|TWO_SIDED|97.5|-0.18|0.02|||mixed-effects model|||||0.02|-0.18|0.092
73869651|NCT01620528|147283242|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|97.5|-0.28|-0.08|||mixed-effects model|||||-0.08|-0.28|< 0.001
73869652|NCT01620528|147283243|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.017|TWO_SIDED|97.5|-0.23|-0.01|||mixed-effects model|||||-0.01|-0.23|0.017
73944970|NCT00691132|147422899|SUPERIORITY_OR_OTHER|||||||0.039|||||||Mixed Models Analysis|||||||0.039
73944971|NCT00691132|147422899|SUPERIORITY_OR_OTHER|||||||0.623|||||||Mixed Models Analysis|||||||0.623
73944972|NCT00691132|147422899|SUPERIORITY_OR_OTHER|||||||0.045|||||||Mixed Models Analysis|||||||0.045
73869653|NCT01620528|147283243|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|97.5|-0.41|-0.18|||mixed-effects model|||||-0.18|-0.41|< 0.001
73869654|NCT01620528|147283244|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|97.5|-0.31|-0.07|||mixed-effects model|||||-0.07|-0.31|< 0.001
73869655|NCT01620528|147283244|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.51|-0.27|||mixed-effects model|||||-0.27|-0.51|< 0.001
73944973|NCT01060553|147422973|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||for mcs||||.15
73944974|NCT01060553|147422973|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||t-test, 2 sided|||for pcs||||.28
73944975|NCT01060553|147422974|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||for sleep duration||||.34
73944976|NCT01060553|147422974|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||for sleep disturbance||||.001
73975806|NCT02568215|147496242|OTHER||Prevention Efficacy (PE)|78.6|||||TWO_SIDED|95.0|17.3|94.4||||||PE against IC80 of least sensitive variant less than 1||94.4|17.3|
73975807|NCT02568215|147496242|OTHER||Prevention Efficacy (PE)|7.4|||||TWO_SIDED|95.0|-187.5|70.2||||||PE against IC80 of least sensitive variant 1-3||70.2|-187.5|
73975808|NCT02568215|147496242|OTHER||Prevention Efficacy (PE)|-1.9|||||TWO_SIDED|95.0|-83.1|43.3||||||PE against IC80 of least sensitive variant \> 3||43.3|-83.1|
73975809|NCT03577106|147496291|OTHER||||||<|0.005||||||t(20)=3.3, p\<0.005|paired t-test|||Mean difference using a paired t-test||||<0.005
73975810|NCT03066609|147496301|SUPERIORITY||Odds Ratio (OR)|153.94|||<|0.0001|TWO_SIDED|95.0|54.02|438.67|||Regression, Logistic|||PASI 75||438.67|54.02|<0.0001
73975811|NCT03066609|147496301|SUPERIORITY||Odds Ratio (OR)|557.98|||<|0.0001|TWO_SIDED|95.0|187.2|1663.4|||Regression, Logistic|||PASI 75||1663.4|187.2|<0.0001
73975812|NCT03066609|147496302|SUPERIORITY||Odds Ratio (OR)|75.82|||<|0.0001|TWO_SIDED|95.0|25.81|222.72|||Regression, Logistic|||IGA||222.72|25.81|<0.0001
73975813|NCT03066609|147496302|SUPERIORITY||Odds Ratio (OR)|149.71|||<|0.0001|TWO_SIDED|95.0|51.83|432.42|||Regression, Logistic|||IGA||432.42|51.83|<0.0001
73975814|NCT03066609|147496303|SUPERIORITY||Odds Ratio (OR)|114.85|||<|0.0001|TWO_SIDED|95.0|26.94|489.59|||Regression, Logistic|||PASI 90||489.59|26.94|<0.0001
73975815|NCT03066609|147496303|SUPERIORITY||Odds Ratio (OR)|246.12|||<|0.0001|TWO_SIDED|95.0|58.41|1037.1|||Regression, Logistic|||PASI 90||1037.1|58.41|<0.0001
73975816|NCT00811941|147496361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.62||0.16|TWO_SIDED|95.0|-2.1|0.35|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. Null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||0.35|-2.10|0.160
73944977|NCT01060553|147422974|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||for sleep latency||||.015
73944978|NCT02037438|147422996|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.03|STANDARD_ERROR_OF_MEAN|0.075||0.687|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.687
73944979|NCT02037438|147422997|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|-0.007|STANDARD_ERROR_OF_MEAN|0.539||0.989|TWO_SIDED||||||see Comments|Heteroscedasticity-Consistent Linear Regression with Fixed Effects for Providers and Baseline Covariate||||||0.989
73944980|NCT02037438|147422998|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.114|STANDARD_ERROR_OF_MEAN|0.141||0.417|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.417
73944981|NCT02037438|147422999|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.057|STANDARD_ERROR_OF_MEAN|0.078||0.468|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.468
73944982|NCT02037438|147423000|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.177|STANDARD_ERROR_OF_MEAN|0.061||0.003|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.003
73944983|NCT02255032|147423001|SUPERIORITY||Mean Difference (Final Values)|-164.44|STANDARD_DEVIATION|173.148||0.0017|TWO_SIDED|95.0|-256.7|-72.2||The primary analysis of the primary efficacy endpoint was the comparison between the Baseline and Month 2 values for the 4 mg treatment group. No adjustments for multiplicity were necessary.|Paired t-test, two-sided|||"A paired t-test was used to assess the statistical significance of the change between Baseline and Month 2.~A sample size of 16 subjects would have 80% power to detect a difference of 75, assuming a standard deviation of 100, using a paired t-test with a 0.050 two-sided significance level."||-72.2|-256.7|0.0017
73944984|NCT05375955|147423002|OTHER||Risk Difference (RD)|12.4||||0.0711|TWO_SIDED|95.0|-4.1|29.4|||Chan and Zhang (1999) method|||||29.4|-4.1|0.0711
73944985|NCT05375955|147423002|OTHER||Risk Difference (RD)|10.1||||0.129|TWO_SIDED|95.0|-6.1|26.8|||Chan and Zhang (1999) method|||||26.8|-6.1|0.1290
73944986|NCT05375955|147423003|OTHER||Risk Difference (RD)|6.3||||0.2712|TWO_SIDED|95.0|-10.8|24.3|||Chan and Zhang (1999) method|||||24.3|-10.8|0.2712
73944987|NCT05375955|147423003|OTHER||Risk Difference (RD)|28.3||||0.0028|TWO_SIDED|95.0|7.7|47.5|||Chan and Zhang (1999) method|||||47.5|7.7|0.0028
73944988|NCT05375955|147423003|OTHER||Risk Difference (RD)|36.6||||0.0003|TWO_SIDED|95.0|14.7|56.4|||Chan and Zhang (1999) method|||||56.4|14.7|0.0003
73944989|NCT05375955|147423004|OTHER||Risk Difference (RD)|0.1||||0.5701|TWO_SIDED|95.0|-10.2|10.7|||Chan and Zhang (1999) method|||Week 1||10.7|-10.2|0.5701
73944990|NCT05375955|147423004|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
73944991|NCT05375955|147423004|OTHER||Risk Difference (RD)|9.6||||0.0532|TWO_SIDED|95.0|-2.0|23.7|||Chan and Zhang (1999) method|||Week 2||23.7|-2.0|0.0532
73944992|NCT05375955|147423004|OTHER||Risk Difference (RD)|4.9||||0.1705|TWO_SIDED|95.0|-6.1|17.6|||Chan and Zhang (1999) method|||Week 2||17.6|-6.1|0.1705
73944993|NCT05375955|147423004|OTHER||Risk Difference (RD)|0.5||||0.5123|TWO_SIDED|95.0|-14.4|15.7|||Chan and Zhang (1999) method|||Week 4||15.7|-14.4|0.5123
73869656|NCT01620528|147283245|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.053||0.004|TWO_SIDED|97.5|-0.27|-0.03|||mixed-effects model|||||-0.03|-0.27|0.004
73869657|NCT01620528|147283245|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.52|-0.27|||mixed-effects model|||||-0.27|-0.52|< 0.001
73869658|NCT01620528|147283246|SUPERIORITY||LS Mean of Difference|-6.23|STANDARD_ERROR_OF_MEAN|2.748||0.024|TWO_SIDED|97.5|-12.4|-0.06|||mixed-effects model|||||-0.06|-12.40|0.024
73869659|NCT01620528|147283246|SUPERIORITY||LS Mean of Difference|-7.72|STANDARD_ERROR_OF_MEAN|2.756||0.005|TWO_SIDED|97.5|-13.9|-1.53|||mixed-effects model|||||-1.53|-13.90|0.005
73944994|NCT05375955|147423004|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 4||22.1|-10.7|0.2751
73944995|NCT05375955|147423004|OTHER||Risk Difference (RD)|7.8||||0.2736|TWO_SIDED|95.0|-8.9|24.8|||Chan and Zhang (1999) method|||Week 6||24.8|-8.9|0.2736
73944996|NCT05375955|147423004|OTHER||Risk Difference (RD)|3.0||||0.3967|TWO_SIDED|95.0|-13.0|19.8|||Chan and Zhang (1999) method|||Week 6||19.8|-13.0|0.3967
73944997|NCT05375955|147423004|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 8||20.2|-13.6|0.3997
73944998|NCT05375955|147423004|OTHER||Risk Difference (RD)|-1.6||||0.5461|TWO_SIDED|95.0|-17.7|15.3|||Chan and Zhang (1999) method|||Week 8||15.3|-17.7|0.5461
74031744|NCT00431847|147616785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3568|STANDARD_ERROR_OF_MEAN|0.4009||0.3741|TWO_SIDED|95.0|-0.4318|1.1453|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.1453|-0.4318|0.3741
74031745|NCT00431847|147616785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2969|STANDARD_ERROR_OF_MEAN|0.5609||0.0213|TWO_SIDED|95.0|0.1938|2.4|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.4000|0.1938|0.0213
73869660|NCT01620528|147283247|SUPERIORITY||LS Mean of Difference|-5.69|STANDARD_ERROR_OF_MEAN|3.226||0.078|TWO_SIDED|97.5|-12.93|1.56|||mixed-effects model|||||1.56|-12.93|0.078
73944999|NCT05375955|147423004|OTHER||Risk Difference (RD)|7.8||||0.2736|TWO_SIDED|95.0|-8.9|24.8|||Chan and Zhang (1999) method|||Week 10||24.8|-8.9|0.2736
73945000|NCT05375955|147423004|OTHER||Risk Difference (RD)|5.4||||0.2754|TWO_SIDED|95.0|-11.0|22.1|||Chan and Zhang (1999) method|||Week 10||22.1|-11.0|0.2754
73945001|NCT05375955|147423004|OTHER||Risk Difference (RD)|12.6||||0.0977|TWO_SIDED|95.0|-4.8|30.3|||Chan and Zhang (1999) method|||Week 12||30.3|-4.8|0.0977
73945002|NCT05375955|147423004|OTHER||Risk Difference (RD)|14.9||||0.0542|TWO_SIDED|95.0|-2.8|33.2|||Chan and Zhang (1999) method|||Week 12||33.2|-2.8|0.0542
73945003|NCT05375955|147423005|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
73945004|NCT05375955|147423005|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|10.1|||Chan and Zhang (1999) method|||Week 1||10.1|-10.6|1.0000
73869661|NCT01620528|147283247|SUPERIORITY||LS Mean of Difference|-13.72|STANDARD_ERROR_OF_MEAN|3.249|<|0.001|TWO_SIDED|97.5|-21.01|-6.42|||mixed-effects model|||||-6.42|-21.01|< 0.001
73869662|NCT01620528|147283248|SUPERIORITY||LS Mean of Difference|-8.47|STANDARD_ERROR_OF_MEAN|3.475||0.015|TWO_SIDED|97.5|-16.27|-0.66|||mixed-effects model|||||-0.66|-16.27|0.015
73869663|NCT01620528|147283248|SUPERIORITY||LS Mean of Difference|-22.49|STANDARD_ERROR_OF_MEAN|3.514|<|0.001|TWO_SIDED|97.5|-30.38|-14.6|||mixed-effects model|||||-14.60|-30.38|< 0.001
73869664|NCT01620528|147283249|SUPERIORITY||LS Mean of Difference|-14.11|STANDARD_ERROR_OF_MEAN|3.673|<|0.001|TWO_SIDED|97.5|-22.36|-5.87|||mixed-effects model|||||-5.87|-22.36|< 0.001
73869665|NCT01620528|147283249|SUPERIORITY||LS Mean of Difference|-30.41|STANDARD_ERROR_OF_MEAN|3.729|<|0.001|TWO_SIDED|97.5|-38.78|-22.04|||mixed-effects model|||||-22.04|-38.78|< 0.001
73869666|NCT01620528|147283250|SUPERIORITY||LS Mean of Difference|-11.55|STANDARD_ERROR_OF_MEAN|3.736||0.002|TWO_SIDED|97.5|-19.94|-3.16|||mixed-effects model|||||-3.16|-19.94|0.002
73869667|NCT01620528|147283250|SUPERIORITY||LS Mean of Difference|-29.68|STANDARD_ERROR_OF_MEAN|3.788|<|0.001|TWO_SIDED|97.5|-38.19|-21.18|||mixed-effects model|||||-21.18|-38.19|< 0.001
73945005|NCT05375955|147423005|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 1||24.3|-2.1|0.0436
73945006|NCT05375955|147423005|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
73945007|NCT05375955|147423005|OTHER||Risk Difference (RD)|2.9||||0.2697|TWO_SIDED|95.0|-7.8|14.9|||Chan and Zhang (1999) method|||Week 2||14.9|-7.8|0.2697
73945008|NCT05375955|147423005|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 2||32.0|3.2|0.0104
73945009|NCT05375955|147423005|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
73945010|NCT05375955|147423005|OTHER||Risk Difference (RD)|14.3||||0.0129|TWO_SIDED|95.0|2.6|30.3|||Chan and Zhang (1999) method|||Week 4||30.3|2.6|0.0129
73945011|NCT05375955|147423005|OTHER||Risk Difference (RD)|21.2||||0.0024|TWO_SIDED|95.0|8.0|38.9|||Chan and Zhang (1999) method|||Week 4||38.9|8.0|0.0024
73945012|NCT05375955|147423005|OTHER||Risk Difference (RD)|21.2||||0.0024|TWO_SIDED|95.0|8.0|38.9|||Chan and Zhang (1999) method|||Week 6||38.9|8.0|0.0024
73945013|NCT05375955|147423005|OTHER||Risk Difference (RD)|22.9||||0.0018|TWO_SIDED|95.0|9.5|40.1|||Chan and Zhang (1999) method|||Week 6||40.1|9.5|0.0018
73945014|NCT05375955|147423005|OTHER||Risk Difference (RD)|33.3||||0.0001|TWO_SIDED|95.0|17.8|51.8|||Chan and Zhang (1999) method|||Week 6||51.8|17.8|0.0001
73945015|NCT05375955|147423005|OTHER||Risk Difference (RD)|15.2||||0.0259|TWO_SIDED|95.0|-0.1|32.5|||Chan and Zhang (1999) method|||Week 8||32.5|-0.1|0.0259
73945016|NCT05375955|147423005|OTHER||Risk Difference (RD)|22.8||||0.0038|TWO_SIDED|95.0|6.3|40.4|||Chan and Zhang (1999) method|||Week 8||40.4|6.3|0.0038
73975817|NCT00811941|147496362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|STANDARD_ERROR_OF_MEAN|2.9||0.232|TWO_SIDED|95.0|-9.17|2.23|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||2.23|-9.17|0.232
73975818|NCT00811941|147496363|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.689|TWO_SIDED|95.0|0.59|1.41|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.41|0.59|0.689
73975819|NCT00811941|147496364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.046|TWO_SIDED|95.0|-0.37|0.0|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.00|-0.37|0.046
73975820|NCT00811941|147496365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.217|TWO_SIDED|95.0|-0.36|0.08|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.||0.08|-0.36|0.217
73975821|NCT00811941|147496366|SUPERIORITY_OR_OTHER||Ratio to placebo|0.93||||0.273|TWO_SIDED|95.0|0.83|1.05|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 319 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||1.05|0.83|0.273
73975822|NCT00811941|147496367|SUPERIORITY_OR_OTHER||Ratio to placebo|0.99||||0.916|TWO_SIDED|95.0|0.9|1.1|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 318 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||1.10|0.90|0.916
73975823|NCT00811941|147496368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.65||0.017|TWO_SIDED|95.0|-2.85|-0.29|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.29|-2.85|0.017
73975824|NCT00811941|147496369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47|STANDARD_ERROR_OF_MEAN|3.07||0.036|TWO_SIDED|95.0|-12.53|-0.42|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.42|-12.53|0.036
73975825|NCT00811941|147496370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.976|TWO_SIDED|95.0|0.67|1.52|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.52|0.67|0.976
73975826|NCT00811941|147496371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.056|TWO_SIDED|95.0|-0.44|0.01|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||0.01|-0.44|0.056
73975827|NCT00811941|147496372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.029||95.0|-0.5|-0.03|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.||-0.03|-0.50|0.029
73869668|NCT01620528|147283251|SUPERIORITY||LS Mean of Difference|-12.37|STANDARD_ERROR_OF_MEAN|3.805||0.001|TWO_SIDED|97.5|-20.92|-3.83|||mixed-effects model|||||-3.83|-20.92|0.001
73945017|NCT05375955|147423005|OTHER||Risk Difference (RD)|30.4||||0.0007|TWO_SIDED|95.0|12.2|48.9|||Chan and Zhang (1999) method|||Week 8||48.9|12.2|0.0007
73945018|NCT05375955|147423005|OTHER||Risk Difference (RD)|21.5||||0.0146|TWO_SIDED|95.0|2.1|41.2|||Chan and Zhang (1999) method|||Week 10||41.2|2.1|0.0146
73945019|NCT05375955|147423005|OTHER||Risk Difference (RD)|19.7||||0.0205|TWO_SIDED|95.0|1.0|38.9|||Chan and Zhang (1999) method|||Week 10||38.9|1.0|0.0205
73945020|NCT05375955|147423005|OTHER||Risk Difference (RD)|39.7||||0.0002|TWO_SIDED|95.0|17.1|59.3|||Chan and Zhang (1999) method|||Week 10||59.3|17.1|0.0002
73945021|NCT05375955|147423005|OTHER||Risk Difference (RD)|12.6||||0.1245|TWO_SIDED|95.0|-7.8|32.6|||Chan and Zhang (1999) method|||Week 12||32.6|-7.8|0.1245
73945022|NCT05375955|147423005|OTHER||Risk Difference (RD)|11.0||||0.1431|TWO_SIDED|95.0|-9.1|31.5|||Chan and Zhang (1999) method|||Week 12||31.5|-9.1|0.1431
73975828|NCT00811941|147496373|SUPERIORITY_OR_OTHER||Ratio to placebo|0.78||||0.001|TWO_SIDED|95.0|0.67|0.9|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 98 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.90|0.67|0.001
73975829|NCT00811941|147496374|SUPERIORITY_OR_OTHER||Ratio to placebo|0.88||||0.037|TWO_SIDED|95.0|0.79|0.99|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.99|0.79|0.037
73975830|NCT03802994|147496375|EQUIVALENCE|Differences between groups were compared using the paired t test|||||<|0.05|TWO_SIDED|80.0|||||t-test, 2 sided|||Differences between groups were compared using the paired t test||||<0.05
73975831|NCT03802994|147496375|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73975832|NCT03802994|147496375|SUPERIORITY||||||<|0.05|TWO_SIDED|80.0|||||t-test, 2 sided|||||||<0.05
73975833|NCT03802994|147496376|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73975834|NCT03802994|147496376|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73975835|NCT03802994|147496377|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73975836|NCT03802994|147496378|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73975837|NCT00622700|147496380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.0087|TWO_SIDED|95.0|0.379|0.869||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure, starting with the test of teriflunomide 14 mg versus placebo was used. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.869|0.379|0.0087
73945023|NCT05375955|147423005|OTHER||Risk Difference (RD)|36.8||||0.0007|TWO_SIDED|95.0|12.2|56.8|||Chan and Zhang (1999) method|||Week 12||56.8|12.2|0.0007
73945024|NCT05375955|147423006|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
73945025|NCT05375955|147423006|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
73945026|NCT05375955|147423006|OTHER||Risk Difference (RD)|4.9||||0.1705|TWO_SIDED|95.0|-6.1|17.6|||Chan and Zhang (1999) method|||Week 2||17.6|-6.1|0.1705
73945027|NCT05375955|147423006|OTHER||Risk Difference (RD)|7.3||||0.1118|TWO_SIDED|95.0|-3.9|20.5|||Chan and Zhang (1999) method|||Week 2||20.5|-3.9|0.1118
73945028|NCT05375955|147423006|OTHER||Risk Difference (RD)|5.2||||0.2751|TWO_SIDED|95.0|-9.5|20.5|||Chan and Zhang (1999) method|||Week 4||20.5|-9.5|0.2751
73945029|NCT05375955|147423006|OTHER||Risk Difference (RD)|2.8||||0.3857|TWO_SIDED|95.0|-11.4|17.6|||Chan and Zhang (1999) method|||Week 4||17.6|-11.4|0.3857
73945030|NCT05375955|147423006|OTHER||Risk Difference (RD)|7.5||||0.1429|TWO_SIDED|95.0|-6.4|22.6|||Chan and Zhang (1999) method|||Week 6||22.6|-6.4|0.1429
73945031|NCT05375955|147423006|OTHER||Risk Difference (RD)|7.5||||0.1429|TWO_SIDED|95.0|-6.4|22.6|||Chan and Zhang (1999) method|||Week 6||22.6|-6.4|0.1429
73945032|NCT05375955|147423006|OTHER||Risk Difference (RD)|9.8||||0.1119|TWO_SIDED|95.0|-4.4|25.3|||Chan and Zhang (1999) method|||Week 8||25.3|-4.4|0.1119
73945033|NCT05375955|147423006|OTHER||Risk Difference (RD)|2.7||||0.3755|TWO_SIDED|95.0|-10.7|16.7|||Chan and Zhang (1999) method|||Week 8||16.7|-10.7|0.3755
73945034|NCT05375955|147423006|OTHER||Risk Difference (RD)|7.7||||0.2547|TWO_SIDED|95.0|-8.4|24.3|||Chan and Zhang (1999) method|||Week 10||24.3|-8.4|0.2547
73945035|NCT05375955|147423006|OTHER||Risk Difference (RD)|2.9||||0.3928|TWO_SIDED|95.0|-12.7|18.6|||Chan and Zhang (1999) method|||Week 10||18.6|-12.7|0.3928
73945036|NCT05375955|147423007|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|11.0|||Chan and Zhang (1999) method|||Week 1||11.0|-10.6|1.0000
73945037|NCT05375955|147423007|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|10.1|||Chan and Zhang (1999) method|||Week 1||10.1|-10.6|1.0000
73945038|NCT05375955|147423007|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
73945039|NCT05375955|147423007|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 2||20.7|-4.9|0.0993
73945040|NCT05375955|147423007|OTHER||Risk Difference (RD)|5.7||||0.114|TWO_SIDED|95.0|-5.3|19.2|||Chan and Zhang (1999) method|||Week 2||19.2|-5.3|0.1140
73945041|NCT05375955|147423007|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
73945042|NCT05375955|147423007|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 4||20.7|-4.9|0.0993
73945043|NCT05375955|147423007|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 4||33.9|4.9|0.0071
73945044|NCT05375955|147423007|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
73945045|NCT05375955|147423007|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 6||32.0|3.2|0.0104
73945046|NCT05375955|147423007|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 6||33.9|4.9|0.0071
73945047|NCT05375955|147423007|OTHER||Risk Difference (RD)|24.2||||0.0011|TWO_SIDED|95.0|10.4|42.3|||Chan and Zhang (1999) method|||Week 6||42.3|10.4|0.0011
73945048|NCT05375955|147423007|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 8||24.3|-2.1|0.0436
73945049|NCT05375955|147423007|OTHER||Risk Difference (RD)|28.6||||0.0003|TWO_SIDED|95.0|14.2|46.3|||Chan and Zhang (1999) method|||Week 8||46.3|14.2|0.0003
73945050|NCT05375955|147423007|OTHER||Risk Difference (RD)|27.3||||0.0007|TWO_SIDED|95.0|12.9|45.8|||Chan and Zhang (1999) method|||Week 8||45.8|12.9|0.0007
73975838|NCT00622700|147496380|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.628||||0.0271|TWO_SIDED|95.0|0.416|0.949||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The second step was the test of teriflunomide 7 mg versus placebo for time to conversion to CDMS. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.949|0.416|0.0271
73975839|NCT00622700|147496381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.651||||0.0003|TWO_SIDED|95.0|0.515|0.822||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The third step was the test of teriflunomide 14 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.822|0.515|0.0003
73975840|NCT00622700|147496381|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.002|TWO_SIDED|95.0|0.54|0.871||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The fourth step was the test of teriflunomide 7 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.871|0.540|0.0020
73975841|NCT02646618|147496397|NON_INFERIORITY|We set δ=2% as a relative margin to the 5% weight loss as clinically meaningful cut point and because 2% is not so small a difference in average weight loss between study conditions that we would have to recruit a prohibitively large sample.|Mean Difference (Net)|2.0||||0.0038|TWO_SIDED|95.0|0.6|3.3|||Mixed Models Analysis|||||3.3|0.6|0.0038
73945051|NCT05375955|147423007|OTHER||Risk Difference (RD)|9.3||||0.1256|TWO_SIDED|95.0|-6.6|26.4|||Chan and Zhang (1999) method|||Week 10||26.4|-6.6|0.1256
73945052|NCT05375955|147423007|OTHER||Risk Difference (RD)|25.5||||0.0038|TWO_SIDED|95.0|7.0|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|7.0|0.0038
73945053|NCT05375955|147423007|OTHER||Risk Difference (RD)|33.5||||0.0007|TWO_SIDED|95.0|12.8|52.6|||Chan and Zhang (1999) method|||Week 10||52.6|12.8|0.0007
73945054|NCT05375955|147423008|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
73945055|NCT05375955|147423008|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
73945056|NCT05375955|147423008|OTHER||Risk Difference (RD)|2.6||||0.3585|TWO_SIDED|95.0|-9.2|15.5|||Chan and Zhang (1999) method|||Week 2||15.5|-9.2|0.3585
73945057|NCT05375955|147423008|OTHER||Risk Difference (RD)|7.4||||0.129|TWO_SIDED|95.0|-5.3|22.1|||Chan and Zhang (1999) method|||Week 2||22.1|-5.3|0.1290
73945058|NCT05375955|147423008|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 4||22.1|-10.7|0.2751
73945059|NCT05375955|147423008|OTHER||Risk Difference (RD)|7.7||||0.2547|TWO_SIDED|95.0|-8.4|24.3|||Chan and Zhang (1999) method|||Week 4||24.3|-8.4|0.2547
73945060|NCT05375955|147423008|OTHER||Risk Difference (RD)|5.2||||0.2751|TWO_SIDED|95.0|-9.5|20.5|||Chan and Zhang (1999) method|||Week 6||20.5|-9.5|0.2751
73945061|NCT05375955|147423008|OTHER||Risk Difference (RD)|12.3||||0.0658|TWO_SIDED|95.0|-3.8|28.8|||Chan and Zhang (1999) method|||Week 6||28.8|-3.8|0.0658
73945062|NCT05375955|147423008|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 8||22.1|-10.7|0.2751
73945063|NCT05375955|147423008|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 8||22.1|-10.7|0.2751
73945064|NCT05375955|147423008|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 10||20.2|-13.6|0.3997
73945065|NCT05375955|147423008|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 10||20.2|-13.6|0.3997
73945066|NCT05375955|147423008|OTHER||Risk Difference (RD)|7.9||||0.2736|TWO_SIDED|95.0|-9.5|25.7|||Chan and Zhang (1999) method|||Week 12||25.7|-9.5|0.2736
73945067|NCT05375955|147423008|OTHER||Risk Difference (RD)|12.7||||0.1119|TWO_SIDED|95.0|-5.6|31.0|||Chan and Zhang (1999) method|||Week 12||31.0|-5.6|0.1119
73945068|NCT05375955|147423009|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|11.0|||Chan and Zhang (1999) method|||Week 1||11.0|-10.6|1.0000
73945069|NCT05375955|147423009|OTHER||Risk Difference (RD)|2.9||||0.2697|TWO_SIDED|95.0|-7.8|14.9|||Chan and Zhang (1999) method|||Week 1||14.9|-7.8|0.2697
73945070|NCT05375955|147423009|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
73945071|NCT05375955|147423009|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 2||20.7|-4.9|0.0993
73945072|NCT05375955|147423009|OTHER||Risk Difference (RD)|5.7||||0.114|TWO_SIDED|95.0|-5.3|19.2|||Chan and Zhang (1999) method|||Week 2||19.2|-5.3|0.1140
73945073|NCT05375955|147423009|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
73945074|NCT05375955|147423009|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 4||20.7|-4.9|0.0993
73945075|NCT05375955|147423009|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 4||33.9|4.9|0.0071
73945076|NCT05375955|147423009|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
73945077|NCT05375955|147423009|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 6||32.0|3.2|0.0104
73975842|NCT02646618|147496398|NON_INFERIORITY|We set δ=2% as a relative margin to the 5% weight loss as clinically meaningful cut point and because 2% is not so small a difference in average weight loss between study conditions that we would have to recruit a prohibitively large sample.|Mean Difference (Net)|1.2||||0.1485|TWO_SIDED|95.0|-0.4|2.8|||Mixed Models Analysis|||||2.8|-0.4|0.1485
73975843|NCT02646618|147496400|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|||||||0.2480
73975844|NCT02646618|147496405|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in energy (kcal/day) intake, the study is powered at 90% to detect whether the Get Social condition is not inferior to the Traditional condition with a noninferiority margin of 182 kcal/day (SD=500 kcal/day)|Mean Difference (Net)|93.0||||0.2025|TWO_SIDED|95.0|-50.0|237.0|||Mixed Models Analysis|||||237|-50|0.2025
73975845|NCT02646618|147496406|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in energy (kcal/day) intake, the study is powered at 90% to detect whether the Get Social condition is not inferior to the Traditional condition with a noninferiority margin of 182 kcal/day (SD=500 kcal/day)|Mean Difference (Net)|-75.0||||0.3323|TWO_SIDED|95.0|-226.0|77.0|||Mixed Models Analysis|||||77|-226|0.3323
73975846|NCT02646618|147496408|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in moderate to vigorous intensity physical activity minutes per day at 12 months, the noninferiority margin is 9.2 min/day(SD=25 min/day). However, we could not analyze the data in that manner and used the test described above.||||||0.3905|||||||Generalized estimating equation|||We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.||||0.3905
73869669|NCT01620528|147283251|SUPERIORITY||LS Mean of Difference|-29.97|STANDARD_ERROR_OF_MEAN|3.868|<|0.001|TWO_SIDED|97.5|-38.66|-21.28|||mixed-effects model|||||-21.28|-38.66|< 0.001
73975847|NCT02646618|147496409|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in moderate to vigorous intensity physical activity minutes per day at 12 months, the noninferiority margin is 9.2 min/day(SD=25 min/day). However, we could not analyze the data in that manner and used the test described above.||||||0.4741|||||||Generalized estimating equation|||We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.||||0.4741
73975848|NCT04035447|147496448|SUPERIORITY|||||||0.519|||||||t-test, 2 sided|||Satisfaction with Therapy (ST)||||0.519
73975849|NCT04035447|147496448|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Satisfaction with Therapist (SWT)||||0.150
73975850|NCT04035447|147496448|SUPERIORITY|||||||0.309|||||||t-test, 2 sided|||Global Improvement (Item 13)||||0.309
73975851|NCT04035447|147496450|SUPERIORITY|||||||0.696|||||||t-test, 2 sided|||||||0.696
73975852|NCT04035447|147496451|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.350
73869670|NCT01620528|147283252|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.038|TWO_SIDED|97.5|-0.22|0.01|||mixed-effects model|||||0.01|-0.22|0.038
73945078|NCT05375955|147423009|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 6||33.9|4.9|0.0071
73945079|NCT05375955|147423009|OTHER||Risk Difference (RD)|24.2||||0.0011|TWO_SIDED|95.0|10.4|42.3|||Chan and Zhang (1999) method|||Week 6||42.3|10.4|0.0011
73945080|NCT05375955|147423009|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 8||24.3|-2.1|0.0436
73945081|NCT05375955|147423009|OTHER||Risk Difference (RD)|28.6||||0.0003|TWO_SIDED|95.0|14.2|46.3|||Chan and Zhang (1999) method|||Week 8||46.3|14.2|0.0003
73945082|NCT05375955|147423009|OTHER||Risk Difference (RD)|27.3||||0.0007|TWO_SIDED|95.0|12.9|45.8|||Chan and Zhang (1999) method|||Week 8||45.8|12.9|0.0007
73945083|NCT05375955|147423009|OTHER||Risk Difference (RD)|6.3||||0.2712|TWO_SIDED|95.0|-10.8|24.3|||Chan and Zhang (1999) method|||Week 10||24.3|-10.8|0.2712
73945084|NCT05375955|147423009|OTHER||Risk Difference (RD)|25.5||||0.0056|TWO_SIDED|95.0|5.4|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|5.4|0.0056
73945085|NCT05375955|147423009|OTHER||Risk Difference (RD)|30.6||||0.0017|TWO_SIDED|95.0|9.7|50.5|||Chan and Zhang (1999) method|||Week 10||50.5|9.7|0.0017
73945086|NCT05375955|147423009|OTHER||Risk Difference (RD)|3.4||||0.3929|TWO_SIDED|95.0|-14.9|21.6|||Chan and Zhang (1999) method|||Week 12||21.6|-14.9|0.3929
73945087|NCT05375955|147423009|OTHER||Risk Difference (RD)|28.2||||0.004|TWO_SIDED|95.0|7.0|47.7|||Chan and Zhang (1999) method|||Week 12||47.7|7.0|0.0040
73945088|NCT05375955|147423009|OTHER||Risk Difference (RD)|33.7||||0.0012|TWO_SIDED|95.0|10.4|53.7|||Chan and Zhang (1999) method|||Week 12||53.7|10.4|0.0012
73945089|NCT05375955|147423012|OTHER||Risk Difference (RD)|2.8||||0.3255|TWO_SIDED|95.0|-8.5|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-8.5|0.3255
73869671|NCT01620528|147283252|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.053||0.488|TWO_SIDED|97.5|-0.16|0.08|||mixed-effects model|||||0.08|-0.16|0.488
73869672|NCT01620528|147283253|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.252|TWO_SIDED|97.5|-0.2|0.07|||mixed-effects model|||||0.07|-0.20|0.252
73869673|NCT01620528|147283253|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.061||0.058|TWO_SIDED|97.5|-0.25|0.02|||mixed-effects model|||||0.02|-0.25|0.058
73945090|NCT05375955|147423012|OTHER||Risk Difference (RD)|-2.5||||0.7181|TWO_SIDED|95.0|-13.3|8.3|||Chan and Zhang (1999) method|||Week 1||8.3|-13.3|0.7181
73945091|NCT05375955|147423012|OTHER||Risk Difference (RD)|18.4||||0.0022|TWO_SIDED|95.0|7.0|34.3|||Chan and Zhang (1999) method|||Week 2||34.3|7.0|0.0022
73945092|NCT05375955|147423012|OTHER||Risk Difference (RD)|14.7||||0.0064|TWO_SIDED|95.0|3.7|31.1|||Chan and Zhang (1999) method|||Week 2||31.1|3.7|0.0064
73945093|NCT05375955|147423012|OTHER||Risk Difference (RD)|13.7||||0.0659|TWO_SIDED|95.0|-3.4|31.5|||Chan and Zhang (1999) method|||Week 4||31.5|-3.4|0.0659
73945094|NCT05375955|147423012|OTHER||Risk Difference (RD)|19.4||||0.0189|TWO_SIDED|95.0|0.9|38.5|||Chan and Zhang (1999) method|||Week 4||38.5|0.9|0.0189
73975853|NCT04035447|147496452|SUPERIORITY|||||||0.274|||||||Fisher Exact|||Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.||||0.274
73975854|NCT04035447|147496453|SUPERIORITY|||||||0.6|||||||Fisher Exact|||Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.||||0.600
73869674|NCT01620528|147283254|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.069||0.009|TWO_SIDED|97.5|-0.34|-0.03|||mixed-effects model|||||-0.03|-0.34|0.009
73869675|NCT01620528|147283254|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.5|-0.18|||mixed-effects model|||||-0.18|-0.50|< 0.001
73945095|NCT05375955|147423012|OTHER||Risk Difference (RD)|3.6||||0.3962|TWO_SIDED|95.0|-14.9|22.3|||Chan and Zhang (1999) method|||Week 6||22.3|-14.9|0.3962
73945096|NCT05375955|147423012|OTHER||Risk Difference (RD)|9.0||||0.2333|TWO_SIDED|95.0|-10.4|29.1|||Chan and Zhang (1999) method|||Week 6||29.1|-10.4|0.2333
73975855|NCT04035447|147496454|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_DEVIATION|8.4||0.1848|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.18||||||0.1848
73975856|NCT04035447|147496455|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|8.4||0.6153|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.07||||||0.6153
73975857|NCT04035447|147496456|SUPERIORITY||Mean Difference (Net)|4.6|STANDARD_DEVIATION|16.1||0.0563|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.28||||||0.0563
73945097|NCT05375955|147423012|OTHER||Risk Difference (RD)|3.6||||0.3962|TWO_SIDED|95.0|-14.9|22.3|||Chan and Zhang (1999) method|||Week 8||22.3|-14.9|0.3962
73945098|NCT05375955|147423012|OTHER||Risk Difference (RD)|11.9||||0.1353|TWO_SIDED|95.0|-7.9|32.7|||Chan and Zhang (1999) method|||Week 8||32.7|-7.9|0.1353
73945099|NCT05375955|147423012|OTHER||Risk Difference (RD)|6.2||||0.2791|TWO_SIDED|95.0|-12.8|25.7|||Chan and Zhang (1999) method|||Week 10||25.7|-12.8|0.2791
73945100|NCT05375955|147423012|OTHER||Risk Difference (RD)|9.0||||0.2333|TWO_SIDED|95.0|-10.4|29.1|||Chan and Zhang (1999) method|||Week 10||29.1|-10.4|0.2333
73945101|NCT05375955|147423012|OTHER||Risk Difference (RD)|11.3||||0.1295|TWO_SIDED|95.0|-7.3|30.6|||Chan and Zhang (1999) method|||Week 12||30.6|-7.3|0.1295
73945102|NCT05375955|147423012|OTHER||Risk Difference (RD)|20.3||||0.0247|TWO_SIDED|95.0|0.1|40.2|||Chan and Zhang (1999) method|||Week 12||40.2|0.1|0.0247
73945103|NCT05375955|147423013|OTHER||Risk Difference (RD)|-4.3||||0.7278|TWO_SIDED|95.0|-21.9|11.5|||Chan and Zhang (1999) method|||Week 1||11.5|-21.9|0.7278
73945104|NCT05375955|147423013|OTHER||Risk Difference (RD)|8.2||||0.2548|TWO_SIDED|95.0|-11.5|28.2|||Chan and Zhang (1999) method|||Week 1||28.2|-11.5|0.2548
73945105|NCT05375955|147423013|OTHER||Risk Difference (RD)|0.9||||0.5162|TWO_SIDED|95.0|-17.5|21.9|||Chan and Zhang (1999) method|||Week 1||21.9|-17.5|0.5162
73975858|NCT04035447|147496457|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.8||0.0265|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.31||||||0.0265
73975859|NCT04035447|147496457|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_DEVIATION|2.6||0.2084|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.18||||||0.2084
73975860|NCT04035447|147496458|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|9.4||0.3512|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of -0.13||||||0.3512
73869676|NCT01620528|147283255|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.073||0.06|TWO_SIDED|97.5|-0.3|0.03|||mixed-effects model|||||0.03|-0.30|0.060
73869677|NCT01620528|147283255|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|97.5|-0.44|-0.1|||mixed-effects model|||||-0.10|-0.44|< 0.001
73869678|NCT01620528|147283256|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.074||0.118|TWO_SIDED|97.5|-0.28|0.05|||mixed-effects model|||||0.05|-0.28|0.118
73869679|NCT01620528|147283256|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|97.5|-0.48|-0.13|||mixed-effects model|||||-0.13|-0.48|< 0.001
73869680|NCT01620528|147283257|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.044||0.313|TWO_SIDED|97.5|-0.14|0.05|||mixed-effects model|||||0.05|-0.14|0.313
73869681|NCT01620528|147283257|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.044||0.006|TWO_SIDED|97.5|-0.22|-0.02|||mixed-effects model|||||-0.02|-0.22|0.006
73869682|NCT01620528|147283258|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.047||0.519|TWO_SIDED|97.5|-0.13|0.07|||mixed-effects model|||||0.07|-0.13|0.519
73869683|NCT01620528|147283258|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|97.5|-0.32|-0.11|||mixed-effects model|||||-0.11|-0.32|< 0.001
73945106|NCT05375955|147423013|OTHER||Risk Difference (RD)|9.3||||0.1663|TWO_SIDED|95.0|-11.4|30.7|||Chan and Zhang (1999) method|||Week 2||30.7|-11.4|0.1663
73945107|NCT05375955|147423013|OTHER||Risk Difference (RD)|16.5||||0.0605|TWO_SIDED|95.0|-4.2|38.3|||Chan and Zhang (1999) method|||Week 2||38.3|-4.2|0.0605
73945108|NCT05375955|147423013|OTHER||Risk Difference (RD)|16.7||||0.0592|TWO_SIDED|95.0|-5.4|41.6|||Chan and Zhang (1999) method|||Week 2||41.6|-5.4|0.0592
73869684|NCT01620528|147283259|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.053||0.037|TWO_SIDED|97.5|-0.23|0.01|||mixed-effects model|||||0.01|-0.23|0.037
73869685|NCT01620528|147283259|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|97.5|-0.41|-0.17|||mixed-effects model|||||-0.17|-0.41|< 0.001
73869686|NCT01620528|147283260|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.053||0.2|TWO_SIDED|97.5|-0.19|0.05|||mixed-effects model|||||0.05|-0.19|0.200
73869687|NCT01620528|147283260|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.42|-0.18|||mixed-effects model|||||-0.18|-0.42|< 0.001
73869688|NCT01620528|147283261|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.094|<|0.001|TWO_SIDED|95.0|-0.72|-0.34|||ANOVA|||||-0.34|-0.72|< 0.001
73869689|NCT01620528|147283261|SUPERIORITY||LS Mean of Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.095|<|0.001|TWO_SIDED|95.0|-0.93|-0.56|||ANOVA|||||-0.56|-0.93|< 0.001
73869690|NCT01620528|147283262|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.58|-0.19|||ANOVA|||||-0.19|-0.58|< 0.001
73869691|NCT01620528|147283262|SUPERIORITY||LS Mean of Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-1.21|-0.82|||ANOVA|||||-0.82|-1.21|< 0.001
73869692|NCT01620528|147283263|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.81|-0.41|||ANOVA|||||-0.41|-0.81|< 0.001
73869693|NCT01620528|147283263|SUPERIORITY||LS Mean of Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.32|-0.92|||ANOVA|||||-0.92|-1.32|< 0.001
73945109|NCT05375955|147423013|OTHER||Risk Difference (RD)|14.0||||0.1246|TWO_SIDED|95.0|-8.6|37.4|||Chan and Zhang (1999) method|||Week 4||37.4|-8.6|0.1246
73945110|NCT05375955|147423013|OTHER||Risk Difference (RD)|16.3||||0.0789|TWO_SIDED|95.0|-7.3|39.7|||Chan and Zhang (1999) method|||Week 4||39.7|-7.3|0.0789
73945111|NCT05375955|147423013|OTHER||Risk Difference (RD)|17.6||||0.0889|TWO_SIDED|95.0|-6.4|43.7|||Chan and Zhang (1999) method|||Week 4||43.7|-6.4|0.0889
73945112|NCT05375955|147423013|OTHER||Risk Difference (RD)|27.5||||0.0097|TWO_SIDED|95.0|4.2|50.7|||Chan and Zhang (1999) method|||Week 6||50.7|4.2|0.0097
73945113|NCT05375955|147423013|OTHER||Risk Difference (RD)|20.7||||0.0294|TWO_SIDED|95.0|-0.8|43.6|||Chan and Zhang (1999) method|||Week 6||43.6|-0.8|0.0294
73945114|NCT05375955|147423013|OTHER||Risk Difference (RD)|37.8||||0.0018|TWO_SIDED|95.0|10.9|62.2|||Chan and Zhang (1999) method|||Week 6||62.2|10.9|0.0018
73945115|NCT05375955|147423013|OTHER||Risk Difference (RD)|23.5||||0.0495|TWO_SIDED|95.0|-3.8|48.9|||Chan and Zhang (1999) method|||Week 8||48.9|-3.8|0.0495
73945116|NCT05375955|147423013|OTHER||Risk Difference (RD)|7.6||||0.289|TWO_SIDED|95.0|-17.3|32.4|||Chan and Zhang (1999) method|||Week 8||32.4|-17.3|0.2890
73945117|NCT05375955|147423013|OTHER||Risk Difference (RD)|35.2||||0.0103|TWO_SIDED|95.0|5.1|62.0|||Chan and Zhang (1999) method|||Week 8||62.0|5.1|0.0103
73945118|NCT05375955|147423013|OTHER||Risk Difference (RD)|19.0||||0.1088|TWO_SIDED|95.0|-7.8|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|-7.8|0.1088
73945119|NCT05375955|147423013|OTHER||Risk Difference (RD)|11.8||||0.2719|TWO_SIDED|95.0|-14.0|36.2|||Chan and Zhang (1999) method|||Week 10||36.2|-14.0|0.2719
73945120|NCT05375955|147423013|OTHER||Risk Difference (RD)|30.0||||0.0227|TWO_SIDED|95.0|0.4|56.6|||Chan and Zhang (1999) method|||Week 10||56.6|0.4|0.0227
73945121|NCT05375955|147423013|OTHER||Risk Difference (RD)|23.5||||0.0495|TWO_SIDED|95.0|-3.8|48.9|||Chan and Zhang (1999) method|||Week 12||48.9|-3.8|0.0495
73869694|NCT01620528|147283264|SUPERIORITY||LS Mean of Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.83|-0.42|||ANOVA|||||-0.42|-0.83|< 0.001
73869695|NCT01620528|147283264|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.107|<|0.001|TWO_SIDED|95.0|-1.47|-1.05|||ANOVA|||||-1.05|-1.47|< 0.001
73869696|NCT01620528|147283265|SUPERIORITY||LS Mean of Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.111|<|0.001|TWO_SIDED|95.0|-0.91|-0.48|||ANOVA|||||-0.48|-0.91|< 0.001
73869697|NCT01620528|147283265|SUPERIORITY||LS Mean of Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|-1.54|-1.1|||ANOVA|||||-1.10|-1.54|< 0.001
73869698|NCT01620528|147283266|SUPERIORITY||LS Mean of Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.96|-0.48|||ANOVA|||||-0.48|-0.96|< 0.001
73869699|NCT01620528|147283266|SUPERIORITY||LS Mean of Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.123|<|0.001|TWO_SIDED|95.0|-1.59|-1.11|||ANOVA|||||-1.11|-1.59|< 0.001
73869700|NCT01620528|147283267|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.109||0.011|TWO_SIDED|95.0|-0.52|-0.03|||mixed-effects model|||||-0.03|-0.52|0.011
73869701|NCT01620528|147283267|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|97.5|-0.65|-0.16|||mixed-effects model|||||-0.16|-0.65|< 0.001
73869702|NCT01620528|147283268|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-0.77|-0.16|||mixed-effects model|||||-0.16|-0.77|<0.001
73869703|NCT01620528|147283268|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.138||-0.96|TWO_SIDED|97.5|-1.27|-0.65|||mixed-effects model|||||-0.65|-1.27|-0.96
73945122|NCT05375955|147423013|OTHER||Risk Difference (RD)|15.9||||0.1246|TWO_SIDED|95.0|-10.6|40.6|||Chan and Zhang (1999) method|||Week 12||40.6|-10.6|0.1246
73945123|NCT05375955|147423013|OTHER||Risk Difference (RD)|30.0||||0.0227|TWO_SIDED|95.0|0.4|56.6|||Chan and Zhang (1999) method|||Week 12||56.6|0.4|0.0227
73945124|NCT00755040|147423070|SUPERIORITY||Odds Ratio (OR)|1.11|||>|0.99|TWO_SIDED|95.0|||||Fisher Exact|||||||>0.99
73945125|NCT00733980|147423072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2479||||0.703||80.0|-0.5887|1.0846|||Mixed-Model Repeated-Measure analysis|||||1.0846|-0.5887|0.703
73945126|NCT00733980|147423073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0169||||0.966|TWO_SIDED|80.0|-0.5231|0.4893|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 1||0.4893|-0.5231|0.966
73945127|NCT00733980|147423073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4299||||0.386|TWO_SIDED|80.0|-0.2063|1.0661|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 2||1.0661|-0.2063|0.386
73945128|NCT00733980|147423073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9413||||0.095|TWO_SIDED|80.0|0.2203|1.6624|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 4||1.6624|0.2203|0.095
73945129|NCT00733980|147423074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9495||||0.209|TWO_SIDED|80.0|-0.0185|1.9175|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||1.9175|-0.0185|0.209
73869704|NCT01620528|147283269|SUPERIORITY||LS Mean of Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.163|<|0.001|TWO_SIDED|97.5|-1.17|-0.44|||mixed-effects model|||||-0.44|-1.17|< 0.001
73869705|NCT01620528|147283269|SUPERIORITY||LS Mean of Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.165|<|0.001|TWO_SIDED|97.5|-1.98|-1.24|||mixed-effects model|||||-1.24|-1.98|< 0.001
73869706|NCT01620528|147283270|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.167|<|0.001|TWO_SIDED|97.5|-1.05|-0.3|||mixed-effects model|||||-0.30|-1.05|< 0.001
73869707|NCT01620528|147283270|SUPERIORITY||LS Mean of Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|97.5|-1.99|-1.23|||mixed-effects model|||||-1.23|-1.99|< 0.001
73869708|NCT01620528|147283271|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.176|<|0.001|TWO_SIDED|97.5|-1.04|-0.25|||mixed-effects model|||||-0.25|-1.04|< 0.001
73869709|NCT01620528|147283271|SUPERIORITY||LS Mean of Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.179|<|0.001|TWO_SIDED|97.5|-2.0|-1.2|||mixed-effects model|||||-1.20|-2.00|< 0.001
73869710|NCT01620528|147283272|SUPERIORITY||Difference in LS Means|-6.29|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|-9.37|-3.21|||ANCOVA|||||-3.21|-9.37|< 0.001
73945130|NCT00733980|147423074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7638||||0.409|TWO_SIDED|80.0|-0.4243|1.9519|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||1.9519|-0.4243|0.409
73945131|NCT00733980|147423074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5363||||0.156|TWO_SIDED|80.0|0.1485|2.9241|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||2.9241|0.1485|0.156
73945132|NCT00733980|147423074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6327||||0.599|TWO_SIDED|80.0|-0.9135|2.1789|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.1789|-0.9135|0.599
73945133|NCT00733980|147423075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9866||||0.181|TWO_SIDED|80.0|-3.8876|-0.0856|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||-0.0856|-3.8876|0.181
73975861|NCT02130557|147496504|SUPERIORITY||Odds Ratio (OR)|1.547||||0.01|TWO_SIDED|95.0|1.072|2.233||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.025.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|A total sample size of 500 Ph+ participants is required for the study to provide \>= 90% power to detect at least 15% difference (assuming 25% in the imatinib vs 40% in the bosutinib arm) in the MMR rates at 12 months (48 weeks) with a 1-sided alpha of 2.5%, and 2 interim futility analyses at 33% and 66% of patients with adequate follow-up with early stopping for futility only (non-binding, O'Brien-Fleming analog beta spending function).||2.233|1.072|0.0100
73869711|NCT01620528|147283272|SUPERIORITY||Difference in LS Means|-9.76|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-12.91|-6.61|||ANCOVA|||||-6.61|-12.91|< 0.001
73945134|NCT00733980|147423075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2538||||0.889|TWO_SIDED|80.0|-2.5922|2.0846|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||2.0846|-2.5922|0.889
73945135|NCT00733980|147423075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3242||||0.867|TWO_SIDED|80.0|-2.8165|2.1681|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 3||2.1681|-2.8165|0.867
73945136|NCT00733980|147423075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8107||||0.721|TWO_SIDED|80.0|-2.1036|3.7251|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||3.7251|-2.1036|0.721
73945137|NCT00733980|147423075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6273||||0.801|TWO_SIDED|80.0|-3.8337|2.5791|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.5791|-3.8337|0.801
73945138|NCT00733980|147423076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.644||||0.355|TWO_SIDED|80.0|-0.2498|1.5378|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||1.5378|-0.2498|0.355
73945139|NCT00733980|147423076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0524||||0.249|TWO_SIDED|80.0|-0.1194|2.2243|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||2.2243|-0.1194|0.249
73945140|NCT00733980|147423076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6473||||0.116|TWO_SIDED|80.0|0.3078|2.9868|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||2.9868|0.3078|0.116
73869712|NCT01620528|147283273|SUPERIORITY||Difference in LS Means|-9.28|STANDARD_ERROR_OF_MEAN|1.72|<|0.001|TWO_SIDED|95.0|-12.66|-5.91|||ANCOVA|||||-5.91|-12.66|< 0.001
73869713|NCT01620528|147283273|SUPERIORITY||Difference in LS Means|-18.75|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-22.22|-15.27|||ANCOVA|||||-15.27|-22.22|< 0.001
73869714|NCT01620528|147283274|SUPERIORITY||Difference in LS Means|-12.57|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-16.48|-8.66|||ANCOVA|||||-8.66|-16.48|< 0.001
73869715|NCT01620528|147283274|SUPERIORITY||Difference in LS Means|-25.1|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-29.12|-21.09|||ANCOVA|||||-21.09|-29.12|< 0.001
73869716|NCT01620528|147283275|SUPERIORITY||LS Mean of Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.94||0.685|TWO_SIDED|95.0|-4.59|3.02|||ANCOVA|||||3.02|-4.59|0.685
73869717|NCT01620528|147283275|SUPERIORITY||Difference in LS Means|-5.04|STANDARD_ERROR_OF_MEAN|2.03||0.013|TWO_SIDED|95.0|-9.04|-1.05|||ANCOVA|||||-1.05|-9.04|0.013
73869718|NCT01620528|147283276|SUPERIORITY||Difference in LS Means|-4.74|STANDARD_ERROR_OF_MEAN|2.39||0.047|TWO_SIDED|95.0|-9.43|-0.05|||ANCOVA|||||-0.05|-9.43|0.047
73869719|NCT01620528|147283276|SUPERIORITY||Difference in LS Means|-13.86|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-18.89|-8.84|||ANCOVA|||||-8.84|-18.89|< 0.001
73869720|NCT01620528|147283277|SUPERIORITY||Difference in LS Means|-4.71|STANDARD_ERROR_OF_MEAN|2.91||0.107|TWO_SIDED|95.0|-10.43|1.02|||ANCOVA|||||1.02|-10.43|0.107
73945141|NCT00733980|147423076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7283||||0.55|TWO_SIDED|80.0|-0.8353|2.292|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.2920|-0.8353|0.550
73869721|NCT01620528|147283277|SUPERIORITY||Difference in LS Means|-17.51|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|-23.52|-11.5|||ANCOVA|||||-11.50|-23.52|< 0.001
73869722|NCT01620528|147283278|SUPERIORITY||Difference in LS Means|0.12|STANDARD_ERROR_OF_MEAN|0.37||0.741|TWO_SIDED|95.0|-0.61|0.85|||ANCOVA|||||0.85|-0.61|0.741
73869723|NCT01620528|147283278|SUPERIORITY||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|0.38||0.002|TWO_SIDED|95.0|-1.9|-0.42|||ANCOVA|||||-0.42|-1.90|0.002
73945142|NCT00733980|147423080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6359||||0.3588|TWO_SIDED|80.0|0.3378|1.1968|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 2||1.1968|0.3378|0.3588
73945143|NCT00733980|147423080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7347||||0.4088|TWO_SIDED|80.0|0.4554|1.1853|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 4||1.1853|0.4554|0.4088
73945144|NCT00733980|147423080|SUPERIORITY_OR_OTHER||Logistic Model|0.9211||||0.8156|TWO_SIDED|80.0|0.5863|1.4471|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 6/ Early withdrawal||1.4471|0.5863|0.8156
73945145|NCT00733980|147423081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4466||||0.361|TWO_SIDED|80.0|-1.3986|8.2917|||ANCOVA|||||8.2917|-1.3986|0.361
73975862|NCT02130557|147496505|SUPERIORITY||Odds Ratio (OR)|1.418||||0.0303|TWO_SIDED|95.0|0.986|2.037||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.||2.037|0.986|0.0303
73975863|NCT02130557|147496506|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.49|2.44|||||Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.||2.44|0.49|
73975864|NCT02130557|147496507|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0037|TWO_SIDED|95.0|1.16|2.61||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.||2.610|1.160|0.0037
73975865|NCT02130557|147496508|SUPERIORITY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.14|1.13|||||Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.||1.13|0.14|
73975866|NCT02130557|147496509|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0749|TWO_SIDED|95.0|0.35|1.17||1-sided p-value based on Gray's test for comparing cumulative incidence function between treatment arms stratified by sokal risk group (low, intermediate, high) and region (1-3). Statistical significance threshold: 1-sided 0.0125.|Gray's test||The hazard ratio (95% CIs) are based on the proportional subdistribution hazards model stratified by Sokal risk group and region.|If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.||1.17|0.35|0.0749
73975867|NCT02130557|147496510|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.2827|TWO_SIDED|95.0|0.37|1.73||1-sided p-value based on log-rank test for comparing survival curves between treatment arms stratified by sokal risk group and region. OS was not tested as EFS was not significant.|Log Rank||The hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.||1.73|0.37|0.2827
73975868|NCT03333109|147496549|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.34||0.002|TWO_SIDED|95.0|-1.77|-0.42|||Mixed Models Analysis|||||-0.42|-1.77|0.002
73975869|NCT03333109|147496549|SUPERIORITY||Median Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.45|-0.93|||Mixed Models Analysis|||||-0.93|-2.45|<0.001
74031746|NCT00431847|147616786|SUPERIORITY_OR_OTHER||Slope|-0.02776|STANDARD_ERROR_OF_MEAN|0.004706|<|0.0001|TWO_SIDED|95.0|-0.03702|-0.0185|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01850|-0.03702|<0.0001
74031747|NCT00431847|147616786|SUPERIORITY_OR_OTHER||Chi-Squared|3.88||||0.2752|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.2752
73945146|NCT00733980|147423082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1167||||0.932|TWO_SIDED|80.0|-1.6387|1.8722|||ANCOVA|||||1.8722|-1.6387|0.932
73945147|NCT00975221|147423189|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH) statistic|39.866|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73945148|NCT00975221|147423190|SUPERIORITY_OR_OTHER||CMH statistic|40.953|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73945149|NCT00975221|147423191|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-13.55|STANDARD_ERROR_OF_MEAN|1.34|<|0.001|TWO_SIDED|95.0|-16.23|-10.88|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo|||-10.88|-16.23|<0.001
73945150|NCT00975221|147423192|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.79|STANDARD_ERROR_OF_MEAN|5.61|<|0.001|TWO_SIDED|95.0|-34.01|-11.57|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo|||-11.57|-34.01|<0.001
73869724|NCT01620528|147283279|SUPERIORITY||Difference in LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.35||0.172|TWO_SIDED|95.0|-1.16|0.21|||ANCOVA|||||0.21|-1.16|0.172
73869725|NCT01620528|147283279|SUPERIORITY||Difference in LS Means|-1.27|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-1.97|-0.57|||ANCOVA|||||-0.57|-1.97|< 0.001
73945151|NCT04858802|147423237|SUPERIORITY||Mean Difference (Net)|4.19|STANDARD_DEVIATION|19.08||0.059|TWO_SIDED|95.0|-0.2|8.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|The null hypothesis was that there would no difference in FSO cross-sectional area between treatment and control sides at Day 45.||8.6|-0.2|0.059
73945152|NCT04858802|147423238|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_DEVIATION|12.98||0.328|TWO_SIDED|95.0|-1.5|4.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45|Day 45||4.5|-1.5|0.328
73945153|NCT04858802|147423238|SUPERIORITY||Mean Difference (Final Values)|-2.75|STANDARD_DEVIATION|12.64||0.063|TWO_SIDED|95.0|-5.7|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180|Day 180||0.2|-5.7|0.063
73945154|NCT04858802|147423239|SUPERIORITY||Mean Difference (Final Values)|50.94|STANDARD_DEVIATION|430.8||0.306|TWO_SIDED|95.0|-47.5|149.4||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 45||149.4|-47.5|0.306
73945155|NCT04858802|147423239|SUPERIORITY||Mean Difference (Final Values)|-27.44|STANDARD_DEVIATION|413.22||0.567|TWO_SIDED|95.0|-122.5|67.6|||t-test, 2 sided|Paired; the threshold for statistical significance was p = 0.05.|Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 180||67.6|-122.5|0.567
73945156|NCT04858802|147423240|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|1.92||0.031|TWO_SIDED|95.0|0.0|0.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 45||0.9|0.0|0.031
73975870|NCT03333109|147496550|SUPERIORITY||Odds Ratio (OR)|1.52||||0.007|TWO_SIDED|95.0|1.12|2.07|||Cochran-Mantel-Haenszel|Haenszel (CMH) test adjusted for stratification factor after missing data were imputed as non-response (NRI).||||2.07|1.12|0.007
73975871|NCT03333109|147496550|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.001|TWO_SIDED|95.0|1.55|3.15|||Cochran-Mantel-Haenszel|Haenszel (CMH) test adjusted for stratification factor after missing data were imputed as non-response (NRI).||||3.15|1.55|<0.001
73869726|NCT01620528|147283280|SUPERIORITY||LS Mean of Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.43||0.016|TWO_SIDED|95.0|-1.9|-0.19|||ANCOVA|||||-0.19|-1.90|0.016
73945157|NCT04858802|147423240|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.27||0.943|TWO_SIDED|95.0|-0.5|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 180||0.5|-0.5|0.943
73945158|NCT04858802|147423241|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|1.24||0.715|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus|Day 45||0.2|-0.3|0.715
73945159|NCT04858802|147423241|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|0.96||0.129|TWO_SIDED|95.0|0.0|0.4|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus|Day 180||0.4|0.0|0.129
73945160|NCT04858802|147423242|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.28|3.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 21||3.60|0.28|1.00
73945161|NCT04858802|147423242|SUPERIORITY||Odds Ratio (OR)|0.79||||0.453|TWO_SIDED|95.0|0.36|1.73||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 45||1.73|0.36|0.453
73945162|NCT04858802|147423242|SUPERIORITY||Odds Ratio (OR)|0.71||||0.219|TWO_SIDED|95.0|0.31|1.61||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 90||1.61|0.31|0.219
73945163|NCT04858802|147423242|SUPERIORITY||Odds Ratio (OR)|0.71||||0.289|TWO_SIDED|95.0|0.31|1.61|||t-test, 2 sided|||Day 180||1.61|0.31|0.289
73945164|NCT04858802|147423243|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|21.12||0.971|TWO_SIDED|95.0|-4.9|4.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|Day 180||4.8|-4.9|0.971
73945165|NCT04858802|147423244|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.56||1|TWO_SIDED|95.0|-0.1|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 45|Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45|0.1|-0.1|1.00
73945166|NCT04858802|147423244|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.42||0.288|TWO_SIDED|95.0|0.0|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 180|Day 180||0.1|0.0|0.288
73975872|NCT03333109|147496551|SUPERIORITY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.07|-0.64|||Mixed Models Analysis|||||-0.64|-2.07|<0.001
73975873|NCT03333109|147496551|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.71|-1.09|||Mixed Models Analysis|||||-1.09|-2.71|<0.001
73869727|NCT01620528|147283280|SUPERIORITY||Difference in LS Means|-1.78|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-2.65|-0.91|||ANCOVA|||||-0.91|-2.65|< 0.001
73945167|NCT04858802|147423245|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.64||0.225|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45|Day 45||0.1|-0.2|0.225
73945168|NCT04858802|147423245|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.65||0.388|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone modified Lund-Mackay score for the frontal sinus at Day 180|Day 180||0.1|-0.2|0.388
73945169|NCT04858802|147423246|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.68||0.537|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 21||0.1|-0.2|0.537
73945170|NCT04858802|147423246|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_DEVIATION|0.54||0.01|TWO_SIDED|95.0|-0.3|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 45||0.0|-0.3|0.010
73945171|NCT04858802|147423246|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.7||0.003|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 90||-0.1|-0.4|0.003
73945172|NCT04858802|147423246|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.66||0.007|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 180||-0.1|-0.4|0.007
73945173|NCT04858802|147423247|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_DEVIATION|35.55||0.634|TWO_SIDED|95.0|-12.8|7.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 21||7.9|-12.8|0.634
73945174|NCT04858802|147423247|SUPERIORITY||Mean Difference (Final Values)|-7.63|STANDARD_DEVIATION|29.04||0.048|TWO_SIDED|95.0|-15.2|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 45||-0.1|-15.2|0.048
73945175|NCT04858802|147423247|SUPERIORITY||Mean Difference (Final Values)|-7.78|STANDARD_DEVIATION|28.79||0.028|TWO_SIDED|95.0|-14.7|-0.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 90||-0.9|-14.7|0.028
73945176|NCT04858802|147423247|SUPERIORITY||Mean Difference (Final Values)|-6.76|STANDARD_DEVIATION|27.99||0.041|TWO_SIDED|95.0|-13.2|-0.3||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 180||-0.3|-13.2|0.041
73945177|NCT04858802|147423248|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.96||0.063|TWO_SIDED|95.0|-0.5|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 21||0.0|-0.5|0.063
73945178|NCT04858802|147423248|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|0.77||0.015|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 45||-0.1|-0.4|0.015
73945179|NCT04858802|147423248|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.78||0.007|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 90||-0.1|-0.4|0.007
73945180|NCT04858802|147423248|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_DEVIATION|0.75||0.034|TWO_SIDED|95.0|-0.4|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 180||0.0|-0.4|0.034
73975874|NCT03333109|147496552|SUPERIORITY||Mean Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.62||0.004|TWO_SIDED|95.0|-2.99|-0.56|||Mixed Models Analysis|||||-0.56|-2.99|0.004
73975875|NCT03333109|147496552|SUPERIORITY||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-4.07|-1.36|||Mixed Models Analysis|||||-1.36|-4.07|<0.001
73975876|NCT01447706|147496555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.007|TWO_SIDED|95.0|0.18|0.76|||Log Rank|||||0.76|0.18|0.007
73975877|NCT01447706|147496555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.023|TWO_SIDED|95.0|1.08|2.98|||Log Rank|||||2.98|1.08|0.023
73975878|NCT01855750|147496556|SUPERIORITY||Hazard Ratio (HR)|0.922||||0.5167|TWO_SIDED|95.0|0.72|1.18|||Log Rank|||||1.180|0.720|0.5167
73975879|NCT01855750|147496557|SUPERIORITY||Hazard Ratio (HR)|0.949||||0.7311|TWO_SIDED|95.0|0.704|1.279|||Log Rank|||||1.279|0.704|0.7311
73869728|NCT01620528|147283281|SUPERIORITY||Difference in LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.44||0.08|TWO_SIDED|95.0|-1.63|0.09|||ANCOVA|||||0.09|-1.63|0.080
73945181|NCT04858802|147423249|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|0.65||0.83|TWO_SIDED|95.0|-0.2|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 21||0.2|-0.2|0.830
73945182|NCT04858802|147423249|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.59||0.829|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 45||0.1|-0.2|0.829
73945183|NCT04858802|147423249|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.64||0.132|TWO_SIDED|95.0|-0.3|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 90||0.0|-0.3|0.132
73945184|NCT04858802|147423249|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.79||0.31|TWO_SIDED|95.0|-0.3|0.1|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 180||0.1|-0.3|0.310
73945185|NCT04858802|147423250|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.48||0.666|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 21||0.1|-0.2|0.666
73945186|NCT04858802|147423250|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.46||0.497|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 45||0.1|-0.2|0.497
73945187|NCT04858802|147423250|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.5||0.235|TWO_SIDED|95.0|-0.2|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 90||0.0|-0.2|0.235
73945188|NCT04858802|147423250|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.41||0.677|TWO_SIDED|95.0|-0.1|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 180||0.1|-0.1|0.677
73945189|NCT04858802|147423251|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|2.48||0.868|TWO_SIDED|95.0|-0.7|0.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 21||0.6|-0.7|0.868
73945190|NCT04858802|147423251|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|2.3||0.823|TWO_SIDED|95.0|-0.5|0.7||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 45||0.7|-0.5|0.823
73975880|NCT01855750|147496558|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.5027|TWO_SIDED|95.0|0.71|1.183|||Log Rank|||||1.183|0.710|0.5027
73975881|NCT01855750|147496559|SUPERIORITY||Odds Ratio (OR)|0.967||||0.8229|TWO_SIDED|95.0|0.722|1.296|||Cochran-Mantel-Haenszel (CMH) Chi-square|||||1.296|0.722|0.8229
73975882|NCT01855750|147496560|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8549|TWO_SIDED|95.0|0.754|1.407|||Log Rank|||||1.407|0.754|0.8549
73975883|NCT01855750|147496561|SUPERIORITY||Hazard Ratio (HR)|1.358||||0.0021|TWO_SIDED|95.0|1.115|1.654|||Log Rank|||||1.654|1.115|0.0021
73869729|NCT01620528|147283281|SUPERIORITY||Difference in LS Means|-1.37|STANDARD_ERROR_OF_MEAN|0.45||0.003|TWO_SIDED|95.0|-2.25|-0.48|||ANCOVA|||||-0.48|-2.25|0.003
73945191|NCT04858802|147423251|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|2.26||1|TWO_SIDED|95.0|-0.5|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 90||0.5|-0.5|1.00
73975884|NCT00490139|147496653|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.048|TWO_SIDED|95.0|0.71|1.0|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.00|0.71|0.048
73975885|NCT00490139|147496653|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.61|TWO_SIDED|95.0|0.81|1.13|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.13|0.81|0.610
73869730|NCT01620528|147283282|SUPERIORITY||Difference in LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.4||0.106|TWO_SIDED|95.0|-1.44|0.14|||ANCOVA|||||0.14|-1.44|0.106
73869731|NCT01620528|147283282|SUPERIORITY||Difference in LS Means|-1.85|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.67|-1.02|||ANCOVA|||||-1.02|-2.67|< 0.001
73975886|NCT00490139|147496654|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.887|||||TWO_SIDED|95.0|0.77|1.02|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.02|0.77|
73975887|NCT00490139|147496654|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.914|||||TWO_SIDED|95.0|0.8|1.05|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.05|0.80|
73869732|NCT01620528|147283283|SUPERIORITY||Difference in LS Means|-0.75|STANDARD_ERROR_OF_MEAN|0.62||0.232|TWO_SIDED|95.0|-1.97|0.48|||ANCOVA|||||0.48|-1.97|0.232
73869733|NCT01620528|147283283|SUPERIORITY||Difference in LS Means|-2.21|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-3.48|-0.93|||ANCOVA|||||-0.93|-3.48|< 0.001
74039464|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.4561|TWO_SIDED|95.0|-0.54|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.24|-0.54|0.4561
73945192|NCT04858802|147423251|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|2.16||0.188|TWO_SIDED|95.0|-0.8|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 180||0.2|-0.8|0.188
73945193|NCT04858802|147423255|SUPERIORITY||Mean Difference (Net)|6.28|STANDARD_DEVIATION|18.12||0.025|TWO_SIDED|95.0|0.8|11.7||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|||11.7|0.8|0.025
73945194|NCT04858802|147423256|SUPERIORITY||Mean Difference (Final Values)|3.98|STANDARD_DEVIATION|12.49||0.04|TWO_SIDED|95.0|0.2|7.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45|Day 45||7.8|0.2|0.04
73945195|NCT04858802|147423256|SUPERIORITY||Median Difference (Final Values)|-3.45|STANDARD_DEVIATION|13.02||0.09|TWO_SIDED|95.0|-7.5|0.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180|Day 180||0.6|-7.5|0.09
73945196|NCT04858802|147423257|SUPERIORITY||Mean Difference (Final Values)|61.54|STANDARD_DEVIATION|460.18||0.375|TWO_SIDED|95.0|-76.7|199.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 45||199.8|-76.7|0.375
73945197|NCT04858802|147423257|SUPERIORITY||Mean Difference (Final Values)|-51.98|STANDARD_DEVIATION|434.64||0.432|TWO_SIDED|95.0|-184.1|80.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 180||80.2|-184.1|0.432
73945198|NCT04858802|147423258|SUPERIORITY||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|2.13||0.023|TWO_SIDED|95.0|0.1|1.4||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 45||1.4|0.1|0.023
73945199|NCT04858802|147423258|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_DEVIATION|2.24||0.646|TWO_SIDED|95.0|-0.8|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 180||0.5|-0.8|0.646
73958081|NCT02503202|147451952|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot B / Lot C)|0.94|||<|0.001|TWO_SIDED|95.0|0.77|1.15||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.15|0.77|<0.001
73958082|NCT02503202|147451953|OTHER||Risk Difference (RD)|1.1||||0.368|TWO_SIDED|95.0|-1.5|4.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||4.0|-1.5|0.368
73958083|NCT02503202|147451953|OTHER||Risk Difference (RD)|0.0||||0.989|TWO_SIDED|95.0|-3.1|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||3.0|-3.1|0.989
73958084|NCT02503202|147451953|OTHER||Risk Difference (RD)|-1.1||||0.361|TWO_SIDED|95.0|-4.1|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||1.5|-4.1|0.361
73958085|NCT02503202|147451953|OTHER||Risk Difference (RD)|1.2||||0.214|TWO_SIDED|95.0|-1.7|3.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||3.3|-1.7|0.214
73958086|NCT02503202|147451954|OTHER||Risk Difference (RD)|4.1||||0.16|TWO_SIDED|95.0|-1.6|9.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site erythema||9.9|-1.6|0.160
73869734|NCT01620528|147283284|SUPERIORITY||Difference in LS Means|-0.92|STANDARD_ERROR_OF_MEAN|0.37||0.013|TWO_SIDED|95.0|-1.65|-0.2|||ANCOVA|||||-0.20|-1.65|0.013
73869735|NCT01620528|147283284|SUPERIORITY||Difference in LS Means|-1.62|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.35|-0.9|||ANCOVA|||||-0.90|-2.35|< 0.001
73869736|NCT01620528|147283285|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.47||0.005|TWO_SIDED|95.0|-2.24|-0.41|||ANCOVA|||||-0.41|-2.24|0.005
73958087|NCT02503202|147451954|OTHER||Risk Difference (RD)|-0.1||||0.971|TWO_SIDED|95.0|-6.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site erythema||6.0|-6.2|0.971
73958088|NCT02503202|147451954|OTHER||Risk Difference (RD)|-4.2||||0.151|TWO_SIDED|95.0|-10.0|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site erythema||1.5|-10.0|0.151
73958089|NCT02503202|147451954|OTHER||Risk Difference (RD)|5.8||||0.016|TWO_SIDED|95.0|1.4|9.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site erythema||9.9|1.4|0.016
73958090|NCT02503202|147451954|OTHER||Risk Difference (RD)|-6.2||||0.12|TWO_SIDED|95.0|-14.0|1.6|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site pain||1.6|-14.0|0.120
73958091|NCT02503202|147451954|OTHER||Risk Difference (RD)|-3.5||||0.38|TWO_SIDED|94.0|-11.4|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site pain||4.4|-11.4|0.380
73958092|NCT02503202|147451954|OTHER||Risk Difference (RD)|2.7||||0.499|TWO_SIDED|95.0|-5.1|10.4|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site pain||10.4|-5.1|0.499
73958093|NCT02503202|147451954|OTHER||Risk Difference (RD)|54.9|||<|0.001|TWO_SIDED|95.0|46.2|62.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site pain||62.3|46.2|<0.001
73945200|NCT02305381|147423279|SUPERIORITY_OR_OTHER||Treatment difference|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.01|-1.5|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \[≤8.0% or \>8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate||-1.50|-2.01|< 0.0001
73945201|NCT02305381|147423279|SUPERIORITY_OR_OTHER||Treatment difference|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.1|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \[≤8.0% or \>8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate||-1.10|-1.61|< 0.0001
73958094|NCT02503202|147451954|OTHER||Risk Difference (RD)|4.0||||0.202|TWO_SIDED|95.0|-2.2|10.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site swelling||10.3|-2.2|0.202
73958095|NCT02503202|147451954|OTHER||Risk Difference (RD)|-0.5||||0.878|TWO_SIDED|95.0|-7.1|6.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site swelling||6.1|-7.1|0.878
73958096|NCT02503202|147451954|OTHER||Risk Difference (RD)|-4.6||||0.154|TWO_SIDED|95.0|-10.9|1.7|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site swelling||1.7|-10.9|0.154
73975888|NCT00490139|147496655|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.078|TWO_SIDED|95.0|0.62|1.03|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.03|0.62|0.078
73958097|NCT02503202|147451954|OTHER||Risk Difference (RD)|13.1|||<|0.001|TWO_SIDED|95.0|7.4|18.6|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site swelling||18.6|7.4|<0.001
73958098|NCT02503202|147451955|OTHER||Risk Difference (RD)|4.6||||0.176|TWO_SIDED|95.0|-2.1|11.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||11.4|-2.1|0.176
73958099|NCT02503202|147451955|OTHER||Risk Difference (RD)|-1.1||||0.769|TWO_SIDED|95.0|-8.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||6.0|-8.2|0.769
73958100|NCT02503202|147451955|OTHER||Risk Difference (RD)|-5.7||||0.1|TWO_SIDED|95.0|-12.5|1.1|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||1.1|-12.5|0.100
73958101|NCT02503202|147451955|OTHER||Risk Difference (RD)|31.4|||<|0.001|TWO_SIDED|95.0|25.6|37.5|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||37.5|25.6|<0.001
73958102|NCT02503202|147451956|OTHER||Risk Difference (RD)|0.0||||0.983|TWO_SIDED|95.0|-4.2|4.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthralgia||4.1|-4.2|0.983
73958103|NCT02503202|147451956|OTHER||Risk Difference (RD)|-0.8||||0.699|TWO_SIDED|95.0|-5.1|3.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthralgia||3.4|-5.1|0.699
73958104|NCT02503202|147451956|OTHER||Risk Difference (RD)|-0.8||||0.716|TWO_SIDED|95.0|-5.1|3.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthralgia||3.5|-5.1|0.716
73958105|NCT02503202|147451956|OTHER||Risk Difference (RD)|6.2||||0.012|TWO_SIDED|95.0|1.8|10.4|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthralgia||10.4|1.8|0.012
73958106|NCT02503202|147451956|OTHER||Risk Difference (RD)|0.7||||0.677|TWO_SIDED|95.0|-2.9|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthritis||4.4|-2.9|0.677
73958107|NCT02503202|147451956|OTHER||Risk Difference (RD)|1.9||||0.25|TWO_SIDED|95.0|-1.4|5.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthritis||5.4|-1.4|0.250
73958108|NCT02503202|147451956|OTHER||Risk Difference (RD)|1.1||||0.46|TWO_SIDED|95.0|-2.1|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthritis||4.5|-2.1|0.460
73958109|NCT02503202|147451956|OTHER||Risk Difference (RD)|3.1||||0.041|TWO_SIDED|95.0|0.2|6.0|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthritis||6.0|0.2|0.041
73958110|NCT02503202|147451957|OTHER||Risk Difference (RD)|-1.5||||0.353|TWO_SIDED|95.0|-5.1|1.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||1.9|-5.1|0.353
73958111|NCT02503202|147451957|OTHER||Risk Difference (RD)|-0.8||||0.62|TWO_SIDED|95.0|-4.2|2.5|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||2.5|-4.2|0.620
73958112|NCT02503202|147451957|OTHER||Risk Difference (RD)|0.8||||0.663|TWO_SIDED|95.0|-2.9|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||4.5|-2.9|0.663
73958113|NCT02503202|147451957|OTHER||Risk Difference (RD)|2.3||||0.202|TWO_SIDED|95.0|-1.8|5.7|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||5.7|-1.8|0.202
73958114|NCT02503202|147451958|OTHER||Risk Difference (RD)|0.7||||0.483|TWO_SIDED|95.0|-1.6|3.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||3.3|-1.6|0.483
73958115|NCT02503202|147451958|OTHER||Risk Difference (RD)|0.4||||0.746|TWO_SIDED|95.0|-2.2|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||3.0|-2.2|0.746
73958116|NCT02503202|147451958|OTHER||Risk Difference (RD)|-0.4||||0.704|TWO_SIDED|95.0|-2.8|2.0|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||2.0|-2.8|0.704
73958117|NCT02503202|147451958|OTHER||Risk Difference (RD)|1.5||||0.151|TWO_SIDED|95.0|-1.3|3.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||3.9|-1.3|0.151
73958118|NCT04897737|147451959|SUPERIORITY||Risk Ratio (RR)|1.83|||<|0.001|TWO_SIDED|95.0|1.19|2.82|||Mixed Models Analysis|||All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and risk differences (RDs) with 95% CIs.||2.82|1.19|<0.001
73869737|NCT01620528|147283285|SUPERIORITY||Difference in LS Means|-1.64|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-2.56|-0.71|||ANCOVA|||||-0.71|-2.56|< 0.001
73945202|NCT02487498|147423295|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) \> -20 mL|Mean Difference (Net)|-0.0182|STANDARD_ERROR_OF_MEAN|0.00813||0.415|TWO_SIDED|95.0|-0.0342|-0.0023|||Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||-0.0023|-0.0342|0.415
73945203|NCT02487498|147423296|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0182|STANDARD_ERROR_OF_MEAN|0.00813|||TWO_SIDED|95.0|-0.0342|-0.0023||||||||-0.0023|-0.0342|
73945204|NCT02487498|147423297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0091|STANDARD_ERROR_OF_MEAN|0.01132|||TWO_SIDED|95.0|-0.0313|0.0131||||||||0.0131|-0.0313|
73945205|NCT02487498|147423298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0086|STANDARD_ERROR_OF_MEAN|0.00874|||TWO_SIDED|95.0|-0.0086|0.0258||||||||0.0258|-0.0086|
73945206|NCT00755222|147423336|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
73945207|NCT00755222|147423337|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||ANOVA|||||||0.046
73945208|NCT00755222|147423338|SUPERIORITY_OR_OTHER|||||||0.164|||||||ANOVA|||||||0.164
73945209|NCT00755222|147423339|SUPERIORITY_OR_OTHER|||||||0.442|||||||ANOVA|||||||0.442
73945210|NCT00755222|147423340|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA|||||||0.095
73945211|NCT02243202|147423341|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.8|||Mixed Model for Repeated Measures|||||-1.8|-5.3|<0.001
73945212|NCT02243202|147423341|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.142|TWO_SIDED|95.0|-3.1|0.4|||Mixed Model for Repeated Measures|||||0.4|-3.1|0.142
73945213|NCT02243202|147423341|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-8.6|-5.2|||Mixed Model for Repeated Measures|||||-5.2|-8.6|<0.001
73945214|NCT02243202|147423342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.15||||0.002|TWO_SIDED|95.0|1.7|10.14|||Generalized linear Mixed Model|||||10.14|1.70|0.002
73945215|NCT02243202|147423342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.825|TWO_SIDED|95.0|0.41|3.06|||Generalized linear Mixed Model|||||3.06|0.41|0.825
73945216|NCT02243202|147423342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.2|||<|0.001|TWO_SIDED|95.0|4.15|25.05|||Generalized linear Mixed Model|||||25.05|4.15|<0.001
73945217|NCT02243202|147423343|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.8||0.456|TWO_SIDED|95.0|-2.1|4.8|||Mixed Model for Repeated Measures|||||4.8|-2.1|0.456
73869738|NCT01620528|147283286|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-2.53|-0.72|||ANCOVA|||||-0.72|-2.53|< 0.001
73945218|NCT02243202|147423343|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.8||0.827|TWO_SIDED|95.0|-3.9|3.1|||Mixed Model for Repeated Measures|||||3.1|-3.9|0.827
73945219|NCT02243202|147423343|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.7||0.015|TWO_SIDED|95.0|-7.7|-0.8|||Mixed Model for Repeated Measures|||||-0.8|-7.7|0.015
73945220|NCT02243202|147423344|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.7|||Mixed Model for Repeated Measures|||||-1.7|-5.3|<0.001
73945221|NCT02243202|147423344|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.153|TWO_SIDED|95.0|-3.1|0.5|||Mixed Model for Repeated Measures|||||0.5|-3.1|0.153
73945222|NCT02243202|147423344|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-8.5|-4.9|||Mixed Model for Repeated Measures|||||-4.9|-8.5|<0.001
73945223|NCT03243422|147423373|SUPERIORITY||change in Standard Deviation|0.002||||0.96|TWO_SIDED|95.0|-0.077|0.081|||Mixed Models Analysis|Three-level linear mixed effects model with an unstructured covariance matrix from the baseline and the year 3 in-person neurocognitive assessment||||0.081|-0.077|0.96
73945224|NCT03243422|147423374|SUPERIORITY||Slope|0.079||||0.15|TWO_SIDED|95.0|-0.029|0.187||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.187|-0.029|0.15
73945225|NCT03243422|147423375|SUPERIORITY||Slope|-0.02||||0.69|TWO_SIDED|95.0|-0.118|0.078||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.078|-0.118|0.69
73945226|NCT03243422|147423376|SUPERIORITY||Slope|0.017||||0.7|TWO_SIDED|95.0|-0.07|0.104||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.104|-0.070|0.70
73945227|NCT03243422|147423377|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.59|TWO_SIDED|95.0|0.61|1.33||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Regression, Cox|Discrete-time interval model||||1.33|0.61|0.59
73945228|NCT03243422|147423378|SUPERIORITY||Slope|0.191||||0.027|TWO_SIDED|95.0|0.022|0.36|||Mixed Models Analysis|||Analysis was restricted to ARIC participants who were enrolled in ACHIEVE||0.360|0.022|0.027
73945229|NCT03243422|147423379|SUPERIORITY||Slope|-0.061||||0.18|TWO_SIDED|95.0|-0.151|0.028|||Mixed Models Analysis|||||0.028|-0.151|0.18
73945230|NCT02173054|147423393|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to compare number of participants who had erythema among 3 groups.|Kruskal-Wallis|||||||0.001
73945231|NCT02173054|147423393|SUPERIORITY_OR_OTHER|||||||0.016||||||This statistical analysis was used to compare number of participants who had dryness among 3 groups|Kruskal-Wallis|||||||0.016
73945232|NCT02173054|147423393|SUPERIORITY_OR_OTHER|||||||0.025||||||This statistical analysis was used to compare number of participants who had scaling among 3 groups.|Kruskal-Wallis|||||||0.025
73869739|NCT01620528|147283286|SUPERIORITY||Difference in LS Means|-2.1|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-3.02|-1.19|||ANCOVA|||||-1.19|-3.02|< 0.001
73945233|NCT02173054|147423393|SUPERIORITY_OR_OTHER|||||||0.571||||||This statistical analysis was used to compare number of participants who had stinging among 3 groups.|Kruskal-Wallis|||||||0.571
73945234|NCT02173054|147423393|SUPERIORITY_OR_OTHER|||||||0.449||||||This statistical analysis was used to compare number of participants who had pruritus among 3 groups.|Kruskal-Wallis|||||||0.449
73869740|NCT01620528|147283287|SUPERIORITY||Difference in LS Means|-1.21|STANDARD_ERROR_OF_MEAN|0.42||0.004|TWO_SIDED|95.0|-2.05|-0.38|||ANCOVA|||||-0.38|-2.05|0.004
73945235|NCT02173054|147423394|SUPERIORITY_OR_OTHER|||||||0.059||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test|||||||0.059
73945236|NCT02173054|147423394|SUPERIORITY_OR_OTHER|||||||0.697||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test|||||||0.697
73945237|NCT02173054|147423394|SUPERIORITY_OR_OTHER|||||||0.028||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.028
73945238|NCT02173054|147423394|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.001
73945239|NCT02173054|147423394|SUPERIORITY_OR_OTHER|||||||0.755||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.755
73945240|NCT02173054|147423394|SUPERIORITY_OR_OTHER|||||||0.003||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.003
73975889|NCT00490139|147496655|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.433|TWO_SIDED|95.0|0.71|1.16|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.16|0.71|0.433
73975890|NCT00490139|147496656|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.853|||||TWO_SIDED|95.0|0.7|1.03|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.03|0.70|
73975891|NCT00490139|147496656|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.863|||||TWO_SIDED|95.0|0.71|1.04|||||The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.04|0.71|
73975892|NCT00490139|147496657|SUPERIORITY_OR_OTHER_LEGACY|Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.811|||||TWO_SIDED|95.0|0.68|0.96||||||||0.96|0.68|
73975893|NCT00490139|147496657|SUPERIORITY_OR_OTHER_LEGACY|Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.1||||||||1.10|0.79|
73975894|NCT00490139|147496658|SUPERIORITY_OR_OTHER_LEGACY|Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.852|||||TWO_SIDED|95.0|0.71|1.02||||||||1.02|0.71|
73975895|NCT00490139|147496658|SUPERIORITY_OR_OTHER_LEGACY|Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.968|||||TWO_SIDED|95.0|0.81|1.16||||||||1.16|0.81|
73869741|NCT01620528|147283287|SUPERIORITY||Difference in LS Means|-2.23|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.06|-1.4|||ANCOVA|||||-1.40|-3.06|< 0.001
73945241|NCT02173054|147423394|SUPERIORITY_OR_OTHER|||||||0.205||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.205
73869742|NCT01620528|147283288|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|0.39||0.013|TWO_SIDED|95.0|-1.74|-0.2|||ANCOVA|||||-0.20|-1.74|0.013
73945242|NCT02173054|147423394|SUPERIORITY_OR_OTHER|||||||0.576||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.576
73945243|NCT02173054|147423394|SUPERIORITY_OR_OTHER|||||||0.16||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.160
73945244|NCT02173054|147423395|SUPERIORITY_OR_OTHER|||||||0.078||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel group|Paired t-test|||||||0.078
73945245|NCT02173054|147423395|SUPERIORITY_OR_OTHER|||||||0.167||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test|||||||0.167
73945246|NCT02173054|147423395|SUPERIORITY_OR_OTHER|||||||0.134||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with Eucerin group|Paired t-test|||||||0.134
73945247|NCT02173054|147423395|SUPERIORITY_OR_OTHER|||||||0.978||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel group|Paired t-test|||||||0.978
73975896|NCT00490139|147496659|SUPERIORITY_OR_OTHER_LEGACY|Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.986|||||TWO_SIDED|95.0|0.74|1.31||||||||1.31|0.74|
73975897|NCT00490139|147496659|SUPERIORITY_OR_OTHER_LEGACY|Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.74|1.31||||||||1.31|0.74|
73975898|NCT02798471|147496662|NON_INFERIORITY|The edoxaban-to-comparator hazard ratio will be computed with 95% confidence interval (CI) (two-sided) based on this model. Edoxaban will be considered non-inferior to comparator if the upper limit of the 95% CI is ≤1.5.|Hazard Ratio (HR)|1.01||||0.9694|TWO_SIDED|95.0|0.594|1.719|||Regression, Cox|||Statistical analysis for the composite primary efficacy endpoint||1.719|0.594|0.9694
73975899|NCT03849937|147496691|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
73975900|NCT03849937|147496691|SUPERIORITY|||||||0.091||||||Time 1 to Time 2|t-test, 2 sided|||||||.091
73975901|NCT03849937|147496691|SUPERIORITY||||||<|0.001||||||Time 2 to Time 3|t-test, 2 sided|||||||<.001
73975902|NCT03849937|147496692|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Effective Communication||||<.001
73975903|NCT03849937|147496692|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Appropriate Communication||||<.001
73975904|NCT03849937|147496692|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Recognizes elderspeak||||<.001
73975905|NCT03849937|147496692|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Recognizes person-centered communication||||<.001
73869743|NCT01620528|147283288|SUPERIORITY||Difference in LS Means|-1.81|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.58|-1.04|||ANCOVA|||||-1.04|-2.58|< 0.001
73869744|NCT01620528|147283289|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|0.48||0.007|TWO_SIDED|95.0|-2.22|-0.34|||ANCOVA|||||-0.34|-2.22|0.007
73945248|NCT02173054|147423395|SUPERIORITY_OR_OTHER|||||||0.273||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test|||||||0.273
73945249|NCT02173054|147423395|SUPERIORITY_OR_OTHER|||||||0.735||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test|||||||0.735
73945250|NCT02173054|147423396|SUPERIORITY_OR_OTHER|||||||0.0002||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel group.|Paired t-test|||||||0.0002
73945251|NCT02173054|147423396|SUPERIORITY_OR_OTHER|||||||0.007||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with placebo moisturizer group.|Paired t-test|||||||0.007
73945252|NCT02173054|147423396|SUPERIORITY_OR_OTHER|||||||0.123||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test|||||||0.123
73945253|NCT02173054|147423397|SUPERIORITY_OR_OTHER|||||||0.005||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.005
73945254|NCT02173054|147423397|SUPERIORITY_OR_OTHER|||||||0.606||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.606
73945255|NCT02173054|147423397|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.001
73945256|NCT01083654|147423398|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.262|TWO_SIDED|95.0|0.2|1.55|||Regression, Logistic|||||1.55|0.20|.262
73945257|NCT00991341|147423402|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.44|TWO_SIDED|95.0|-0.6|0.26|||ANCOVA|The treatment groups were compared with respect to the change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.17, positive values are in favor of longer storage duration.|||0.26|-0.60|0.44
73945258|NCT00991341|147423403|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.5|TWO_SIDED|95.0|0.48|1.43|||Regression, Cox|The treatment groups were compared with respect to all-cause mortality, adjusting for baseline MODS.|The longer storage duration arm is the reference category.|||1.43|0.48|0.50
73975906|NCT02760654|147496704|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
73975907|NCT02760654|147496705|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
73975908|NCT02760654|147496706|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
73869745|NCT01620528|147283289|SUPERIORITY||Difference in LS Means|-2.49|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.44|-1.54|||ANCOVA|||||-1.54|-3.44|< 0.001
73945259|NCT00991341|147423404|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2|TWO_SIDED|95.0|-0.82|0.17|||ANCOVA|The treatment groups were compared with respect to 28-day change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.32; positive values are in favor of longer storage duration.|||0.17|-0.82|0.20
73975909|NCT02760654|147496707|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
73975910|NCT02760654|147496708|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
73975911|NCT02760654|147496709|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
73975912|NCT02760654|147496710|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
73975913|NCT02760654|147496711|EQUIVALENCE|Descriptive statistics (Mean, SD) were calculated for the 7 items of the Adapted Acceptability E-Scale|Calculated Mean and Standard Deviation|0.05|||||TWO_SIDED|||||||||||||
73975914|NCT02760654|147496712|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
73975915|NCT02760654|147496713|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
73975916|NCT00065182|147496720|SUPERIORITY||Hazard Ratio (HR)|1.007||||0.946|TWO_SIDED|95.0|0.813|1.248|||Log Rank||Unadjusted hazard ratio.|||1.248|0.813|0.9460
73975917|NCT00065182|147496720|SUPERIORITY||Hazard Ratio (HR)|0.977|||||TWO_SIDED|95.0|0.788|1.21|||||Adjusted hazard ratio.|||1.210|0.788|
73975918|NCT03442777|147496743|SUPERIORITY||Risk Ratio (RR)|0.64||||0.04|TWO_SIDED|95.0|0.41|0.99||controlled for type of ward (ICU/Non-ICU)|Cochran-Mantel-Haenszel|||||0.99|0.41|0.04
73975919|NCT03801148|147496750|EQUIVALENCE|Natural log (ln)-transformed-Cmax, was analyzed using an analysis of variance (ANOVA) model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric least square mean (LSM) ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|0.98|||||TWO_SIDED|90.0|0.9171|1.0473||||||||1.0473|0.9171|
73869746|NCT01620528|147283290|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.87||0.326|TWO_SIDED|95.0|-2.57|0.85|||ANCOVA|||||0.85|-2.57|0.326
73945260|NCT00991341|147423405|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.018||||0.5|TWO_SIDED|95.0|-0.033|0.069|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.069|-0.033|0.50
73945261|NCT00991341|147423406|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.027||||0.4|TWO_SIDED|95.0|-0.09|0.035|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.035|-0.090|0.40
73945262|NCT00991341|147423407|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.018||||0.41|TWO_SIDED|95.0|-0.059|0.023|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.023|-0.059|0.41
73945263|NCT00991341|147423408|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.75|TWO_SIDED|95.0|-0.62|0.37|||Kruskal-Wallis|||||0.37|-0.62|0.75
73945264|NCT00991341|147423409|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.62|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|The treatment arms were compared with respect to the change in creatinine, adjusting for the baseline creatinine value.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline creatinine, the difference in the means was -0.02, positive values are in favor of longer storage duration.|||0.05|-0.08|0.62
73945265|NCT00991341|147423410|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.93||||0.35|TWO_SIDED|95.0|-2.11|5.98||The treatment arms were compared with respect to the change in troponin-I, adjusting for the baseline troponin-I value.|ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline troponin-I, the change in troponin-I values was 1.9 ng/mL higher in the shorter storage red blood cell units arm.|Troponin-I values recorded as 'too low to detect' were recoded as 0 since the median value of the minimum quantitative troponin-I value obtained among all participating sites was 0.01.||5.98|-2.11|0.35
73945266|NCT00991341|147423411|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Kruskal-Wallis|||||||0.10
73945267|NCT00991341|147423412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65|||<|0.01|TWO_SIDED|95.0|-0.89|-0.41|||ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline bilirubin, the change in bilirubin values was 0.65 mg/dL lower in the shorter storage red blood cell units arm.|||-0.41|-0.89|<0.01
73945268|NCT00991341|147423414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.11|TWO_SIDED|95.0|0.98|1.25||The treatment groups were compared with respect to days to first post-operative bowel movement, adjusting for baseline MODS.|Regression, Cox||The longer storage duration arm is reference category.|||1.25|0.98|0.11
73945269|NCT00991341|147423415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.22|TWO_SIDED|95.0|0.96|1.22|||Regression, Cox|The treatment groups were compared with respect to days to first post-operative solid food, adjusting for baseline MODS.|The longer storage duration arm is reference category.|||1.22|0.96|0.22
73945270|NCT00991341|147423416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.71|TWO_SIDED|95.0|-0.59|1.0|||Kruskal-Wallis||The longer storage duration arm is reference category.|||1.00|-0.59|0.71
73945271|NCT00991341|147423417|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.015||||0.53|TWO_SIDED|95.0|-0.057|0.027|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.027|-0.057|0.53
73945272|NCT02401464|147423418|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|Least Squares (LS) mean difference (ln)|0.963|||||TWO_SIDED|90.0|0.927|1.001||||||Based on the analysis of variance (ANOVA) in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% confidence intervals (CIs) for the differences between the formulations and between the periods.||1.001|0.927|
73945273|NCT02401464|147423419|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1)90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.906|||||TWO_SIDED|90.0|0.88|0.933||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||0.933|0.880|
73945274|NCT02401464|147423420|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.985|||||TWO_SIDED|90.0|0.958|1.011||||||Based on the ANOVA in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||1.011|0.958|
73975920|NCT03801148|147496750|EQUIVALENCE|ln-transformed-Cmax, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|1.0737|||||TWO_SIDED|90.0|1.0025|1.1501||||||||1.1501|1.0025|
73975921|NCT03801148|147496751|EQUIVALENCE|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.0455|||||TWO_SIDED|90.0|1.007|1.0855||||||||1.0855|1.0070|
73945275|NCT02401464|147423421|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.979|||||TWO_SIDED|90.0|0.938|1.022||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||1.022|0.938|
73945276|NCT00215540|147423463|SUPERIORITY_OR_OTHER|||||||0.476||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.476
73945277|NCT00215540|147423463|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.208
73945278|NCT00215540|147423464|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.500
73945279|NCT00215540|147423464|SUPERIORITY_OR_OTHER|||||||0.146||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.146
73945280|NCT00215540|147423465|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.267
73945281|NCT00215540|147423465|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.313
73945282|NCT00215540|147423465|SUPERIORITY_OR_OTHER|||||||0.944||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.944
73945283|NCT00215540|147423466|SUPERIORITY_OR_OTHER|||||||0.476||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.476
73945284|NCT00215540|147423466|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.208
73945285|NCT00215540|147423466|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.046
73945286|NCT00215540|147423467|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.285
73945287|NCT00215540|147423467|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.229
73945288|NCT00215540|147423467|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.030
73945289|NCT00215540|147423468|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.483
74031748|NCT00431847|147616786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3079|STANDARD_ERROR_OF_MEAN|0.1918||0.1094|TWO_SIDED|95.0|-0.6851|0.06941|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.06941|-0.6851|0.1094
73945290|NCT00215540|147423468|SUPERIORITY_OR_OTHER|||||||0.123||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.123
73945291|NCT00215540|147423468|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.006
73945292|NCT00215540|147423469|SUPERIORITY_OR_OTHER|||||||0.843||95.0|||||ANOVA|Adjusting for pooled study center||||||0.843
73945293|NCT00215540|147423469|SUPERIORITY_OR_OTHER|||||||0.543||95.0|||||ANOVA|Adjusting for pooled study center||||||0.543
73945294|NCT00215540|147423469|SUPERIORITY_OR_OTHER|||||||0.537||95.0|||||ANOVA|Adjusting for pooled study center||||||0.537
73945295|NCT00215540|147423470|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||ANOVA|Adjusting for pooled study center||||||0.813
73945296|NCT00215540|147423470|SUPERIORITY_OR_OTHER|||||||0.449||95.0|||||ANOVA|Adjusting for pooled study center||||||0.449
73945297|NCT00215540|147423470|SUPERIORITY_OR_OTHER|||||||0.275||95.0|||||ANOVA|Adjusting for pooled study center||||||0.275
73945298|NCT00215540|147423471|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.267
73945299|NCT00215540|147423471|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.313
73945300|NCT00215540|147423472|SUPERIORITY_OR_OTHER|||||||0.311||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.311
73945301|NCT00215540|147423472|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.516
73945302|NCT00215540|147423472|SUPERIORITY_OR_OTHER|||||||0.094||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.094
73945303|NCT03010462|147423473|SUPERIORITY|||||||0.62|||||||Chi-squared, Corrected|||||||0.62
73945304|NCT03010462|147423474|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
73945305|NCT03010462|147423475|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
73945306|NCT03010462|147423476|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
73945307|NCT03010462|147423477|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
73945308|NCT00431184|147423502|SUPERIORITY_OR_OTHER|||||||0.22|||||||Mixed Models Analysis|||||||0.22
73945309|NCT00431184|147423503|SUPERIORITY_OR_OTHER|||||||0.83|||||||Mixed Models Analysis|||||||0.83
73945310|NCT02799472|147423508|OTHER||Ratio|14.201|||<|0.001|TWO_SIDED|95.0|6.251|32.262|||Repeated measures analysis|||GM-CSF - Complex, Week 1||32.262|6.251|<0.001
73945311|NCT02799472|147423508|OTHER||Ratio|32.36|||<|0.001|TWO_SIDED|95.0|15.828|66.156|||Repeated measures analysis|||GM-CSF - Complex, Week 2||66.156|15.828|<0.001
73945312|NCT02799472|147423508|OTHER||Ratio|55.772|||<|0.001|TWO_SIDED|95.0|25.646|121.287|||Repeated measures analysis|||GM-CSF - Complex, Week 4||121.287|25.646|<0.001
73945313|NCT02799472|147423508|OTHER||Ratio|48.336|||<|0.001|TWO_SIDED|95.0|19.341|120.798|||Repeated measures analysis|||GM-CSF - Complex, Week 6||120.798|19.341|<0.001
73945314|NCT02799472|147423508|OTHER||Ratio|34.635|||<|0.001|TWO_SIDED|95.0|13.69|87.629|||Repeated measures analysis|||GM-CSF - Complex, Week 8||87.629|13.690|<0.001
73945315|NCT02799472|147423508|OTHER||Ratio|23.249|||<|0.001|TWO_SIDED|95.0|8.579|63.005|||Repeated measures analysis|||GM-CSF - Complex, Week 12||63.005|8.579|<0.001
73869747|NCT01620528|147283290|SUPERIORITY||Difference in LS Means|-1.93|STANDARD_ERROR_OF_MEAN|0.89||0.031|TWO_SIDED|95.0|-3.67|-0.18|||ANCOVA|||||-0.18|-3.67|0.031
73869748|NCT01620528|147283291|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.88||0.107|TWO_SIDED|95.0|-3.13|0.31|||ANCOVA|||||0.31|-3.13|0.107
73869749|NCT01620528|147283291|SUPERIORITY||Difference in LS Means|-3.52|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.28|-1.75|||ANCOVA|||||-1.75|-5.28|< 0.001
73869750|NCT01620528|147283292|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.82||0.219|TWO_SIDED|95.0|-2.63|0.6|||ANCOVA|||||0.60|-2.63|0.219
73869751|NCT01620528|147283292|SUPERIORITY||Difference in LS Means|-2.93|STANDARD_ERROR_OF_MEAN|0.84|<|0.001|TWO_SIDED|95.0|-4.59|-1.28|||ANCOVA|||||-1.28|-4.59|< 0.001
73869752|NCT01620528|147283293|SUPERIORITY||Difference in LS Means|-1.6|STANDARD_ERROR_OF_MEAN|0.72||0.026|TWO_SIDED|95.0|-3.01|-0.19|||ANCOVA|||||-0.19|-3.01|0.026
73869753|NCT01620528|147283293|SUPERIORITY||Difference in LS Means|-3.89|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|-5.34|-2.43|||ANCOVA|||||-2.43|-5.34|< 0.001
73869754|NCT01620528|147283294|SUPERIORITY||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.76||0.502|TWO_SIDED|95.0|-2.0|0.98|||ANCOVA|||||0.98|-2.00|0.502
73869755|NCT01620528|147283294|SUPERIORITY||Difference in LS Means|-3.13|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-4.7|-1.56|||ANCOVA|||||-1.56|-4.70|< 0.001
73869756|NCT01620528|147283295|SUPERIORITY||Difference in LS Means|-1.36|STANDARD_ERROR_OF_MEAN|0.85||0.108|TWO_SIDED|95.0|-3.02|0.3|||ANCOVA|||||0.30|-3.02|0.108
73869757|NCT01620528|147283295|SUPERIORITY||Difference in LS Means|-4.47|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.19|-2.74|||ANCOVA|||||-2.74|-6.19|< 0.001
73869758|NCT01620528|147283296|SUPERIORITY||Difference in LS Means|-1.19|STANDARD_ERROR_OF_MEAN|0.36||0.001|TWO_SIDED|95.0|-1.9|-0.48|||ANCOVA|||||-0.48|-1.90|0.001
73869759|NCT01620528|147283296|SUPERIORITY||Difference in LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.004|TWO_SIDED|95.0|-1.76|-0.34|||ANCOVA|||||-0.34|-1.76|0.004
73869760|NCT01620528|147283297|SUPERIORITY||Difference in LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.38||0.045|TWO_SIDED|95.0|-1.49|-0.02|||mixed-effects model|||||-0.02|-1.49|0.045
73869761|NCT01620528|147283297|SUPERIORITY||Difference in LS Means|-1.06|STANDARD_ERROR_OF_MEAN|0.38||0.006|TWO_SIDED|95.0|-1.81|-0.31|||ANCOVA|||||-0.31|-1.81|0.006
73945316|NCT02799472|147423508|OTHER||Ratio|1.233||||0.401|TWO_SIDED|95.0|0.742|2.048|||Repeated measures analysis|||GM-CSF - Complex, 12-Week FU||2.048|0.742|0.401
73945317|NCT02799472|147423509|OTHER||Ratio|0.943||||0.193|TWO_SIDED|95.0|0.861|1.032|||Repeated measures analysis|||14-3-3 ETA Protein, Week 1||1.032|0.861|0.193
73945318|NCT02799472|147423509|OTHER||Ratio|1.028||||0.842|TWO_SIDED|95.0|0.776|1.362|||Repeated measures analysis|||14-3-3 ETA Protein, Week 2||1.362|0.776|0.842
73945319|NCT02799472|147423509|OTHER||Ratio|0.743||||0.127|TWO_SIDED|95.0|0.505|1.093|||Repeated measures analysis|||14-3-3 ETA Protein, Week 4||1.093|0.505|0.127
73945320|NCT02799472|147423509|OTHER||Ratio|0.762||||0.137|TWO_SIDED|95.0|0.531|1.095|||Repeated measures analysis|||14-3-3 ETA Protein, Week 6||1.095|0.531|0.137
73869762|NCT01620528|147283298|SUPERIORITY||Difference in LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.33||0.103|TWO_SIDED|95.0|-1.19|0.11|||ANCOVA|||||0.11|-1.19|0.103
73869763|NCT01620528|147283298|SUPERIORITY||Difference in LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.34||0.003|TWO_SIDED|95.0|-1.64|-0.32|||ANCOVA|||||-0.32|-1.64|0.003
73869764|NCT01620528|147283299|SUPERIORITY||Difference in LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.36||0.39|TWO_SIDED|95.0|-1.01|0.4|||ANCOVA|||||0.40|-1.01|0.390
73869765|NCT01620528|147283299|SUPERIORITY||Difference in LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.003|TWO_SIDED|95.0|-1.75|-0.35|||ANCOVA|||||-0.35|-1.75|0.003
73869766|NCT01620528|147283300|SUPERIORITY||Difference in LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.46|TWO_SIDED|95.0|-0.72|0.32|||ANCOVA|||||0.32|-0.72|0.460
73869767|NCT01620528|147283300|SUPERIORITY||Difference in LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.57|-0.52|||ANCOVA|||||-0.52|-1.57|< 0.001
73869768|NCT01620528|147283301|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.35||0.095|TWO_SIDED|95.0|-1.28|0.1|||ANCOVA|||||0.10|-1.28|0.095
73869769|NCT01620528|147283301|SUPERIORITY||Difference in LS Means|-1.3|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.01|-0.59|||ANCOVA|||||-0.59|-2.01|< 0.001
73945321|NCT02799472|147423509|OTHER||Ratio|0.886||||0.488|TWO_SIDED|95.0|0.623|1.259|||Repeated measures analysis|||14-3-3 ETA Protein, Week 8||1.259|0.623|0.488
73945322|NCT02799472|147423509|OTHER||Ratio|0.793||||0.338|TWO_SIDED|95.0|0.488|1.29|||Repeated measures analysis|||14-3-3 ETA Protein, Week 12||1.290|0.488|0.338
73945323|NCT02799472|147423509|OTHER||Ratio|0.859||||0.582|TWO_SIDED|95.0|0.491|1.502|||Repeated measures analysis|||14-3-3 ETA Protein, 12-Week FU||1.502|0.491|0.582
73945324|NCT02799472|147423509|OTHER||Ratio|0.999||||0.996|TWO_SIDED|95.0|0.699|1.427|||Repeated measures analysis|||S100 CBP A8 and A9, Week 1||1.427|0.699|0.996
73945325|NCT02799472|147423509|OTHER||Ratio|0.944||||0.745|TWO_SIDED|95.0|0.662|1.346|||Repeated measures analysis|||S100 CBP A8 and A9, Week 2||1.346|0.662|0.745
73945326|NCT02799472|147423509|OTHER||Ratio|1.017||||0.939|TWO_SIDED|95.0|0.649|1.593|||Repeated measures analysis|||S100 CBP A8 and A9, Week 4||1.593|0.649|0.939
73975922|NCT03801148|147496751|EQUIVALENCE|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.061|||||TWO_SIDED|90.0|1.0192|1.1046||||||||1.1046|1.0192|
73945327|NCT02799472|147423509|OTHER||Ratio|0.981||||0.937|TWO_SIDED|95.0|0.595|1.617|||Repeated measures analysis|||S100 CBP A8 and A9, Week 6||1.617|0.595|0.937
73945328|NCT02799472|147423509|OTHER||Ratio|1.067||||0.787|TWO_SIDED|95.0|0.659|1.727|||Repeated measures analysis|||S100 CBP A8 and A9, Week 8||1.727|0.659|0.787
73945329|NCT02799472|147423509|OTHER||Ratio|1.267||||0.342|TWO_SIDED|95.0|0.769|2.086|||Repeated measures analysis|||S100 CBP A8 and A9, Week 12||2.086|0.769|0.342
73945330|NCT02799472|147423509|OTHER||Ratio|1.748||||0.026|TWO_SIDED|95.0|1.076|2.838|||Repeated measures analysis|||S100 CBP A8 and A9, 12-Week FU||2.838|1.076|0.026
73945331|NCT02799472|147423510|OTHER||Ratio|0.774||||0.632|TWO_SIDED|95.0|0.261|2.29|||Repeated measures analysis|||Amyloid A, Week 12||2.290|0.261|0.632
73869770|NCT01620528|147283302|SUPERIORITY||Difference in LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.97||0.462|TWO_SIDED|95.0|-2.61|1.19|||ANCOVA|||||1.19|-2.61|0.462
73945332|NCT02799472|147423510|OTHER||Ratio|1.176||||0.685|TWO_SIDED|95.0|0.519|2.663|||Repeated measures analysis|||Amyloid A, 12-Week FU||2.663|0.519|0.685
73945333|NCT02799472|147423511|OTHER||Ratio|0.692||||0.097|TWO_SIDED|95.0|0.445|1.074|||Repeated measures analysis|||CL17, Week 1||1.074|0.445|0.097
73975923|NCT03801148|147496752|EQUIVALENCE|ln-transformed- AUC0\_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infobs.|Geometric LSM ratio|1.0553|||||TWO_SIDED|90.0|1.0186|1.0933||||||||1.0933|1.0186|
73975924|NCT03801148|147496752|EQUIVALENCE|ln-transformed- AUC0\_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infobs.|GMR|1.0468|||||TWO_SIDED|90.0|1.0027|1.0929||||||||1.0929|1.0027|
74031749|NCT00431847|147616786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0428|STANDARD_ERROR_OF_MEAN|0.28||0.8786|TWO_SIDED|95.0|-0.5079|0.5935|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.5935|-0.5079|0.8786
73945334|NCT02799472|147423511|OTHER||Ratio|0.713||||0.229|TWO_SIDED|95.0|0.407|1.249|||Repeated measures analysis|||CL17, Week 2||1.249|0.407|0.229
73945335|NCT02799472|147423511|OTHER||Ratio|0.608||||0.055|TWO_SIDED|95.0|0.365|1.012|||Repeated measures analysis|||CL17, Week 4||1.012|0.365|0.055
73945336|NCT02799472|147423511|OTHER||Ratio|0.755||||0.307|TWO_SIDED|95.0|0.435|1.309|||Repeated measures analysis|||CL17, Week 6||1.309|0.435|0.307
73945337|NCT02799472|147423511|OTHER||Ratio|0.557||||0.017|TWO_SIDED|95.0|0.348|0.894|||Repeated measures analysis|||CL17, Week 8||0.894|0.348|0.017
73945338|NCT02799472|147423511|OTHER||Ratio|0.52||||0.026|TWO_SIDED|95.0|0.294|0.922|||Repeated measures analysis|||||0.922|0.294|0.026
73945339|NCT02799472|147423511|OTHER||Ratio|0.947||||0.839|TWO_SIDED|95.0|0.548|1.636|||Repeated measures analysis|||CL17, 12-Week FU||1.636|0.548|0.839
73945340|NCT02799472|147423511|OTHER||Ratio|0.764||||0.142|TWO_SIDED|95.0|0.53|1.1|||Repeated measures analysis|||CL13, Week 1||1.100|0.530|0.142
73945341|NCT02799472|147423511|OTHER||Ratio|1.005||||0.976|TWO_SIDED|95.0|0.726|1.39|||Repeated measures analysis|||CL13, Week 2||1.390|0.726|0.976
73945342|NCT02799472|147423511|OTHER||Ratio|1.236||||0.244|TWO_SIDED|95.0|0.859|1.778|||Repeated measures analysis|||CL13, Week 4||1.778|0.859|0.244
73945343|NCT02799472|147423511|OTHER||Ratio|1.237||||0.278|TWO_SIDED|95.0|0.836|1.83|||Repeated measures analysis|||CL13, Week 6||1.830|0.836|0.278
73945344|NCT02799472|147423511|OTHER||Ratio|1.118||||0.677|TWO_SIDED|95.0|0.651|1.92|||Repeated measures analysis|||CL13, Week 8||1.920|0.651|0.677
73945345|NCT02799472|147423511|OTHER||Ratio|1.165||||0.661|TWO_SIDED|95.0|0.573|2.369|||Repeated measures analysis|||CL13, Week 12||2.369|0.573|0.661
73945346|NCT02799472|147423511|OTHER||Ratio|1.581||||0.154|TWO_SIDED|95.0|0.832|3.007|||Repeated measures analysis|||CL13, 12-Week FU||3.007|0.832|0.154
73945347|NCT02799472|147423511|OTHER||Ratio|0.903||||0.751|TWO_SIDED|95.0|0.471|1.729|||Repeated measures analysis|||Interleukin 6, Week 1||1.729|0.471|0.751
73945348|NCT02799472|147423511|OTHER||Ratio|0.72||||0.33|TWO_SIDED|95.0|0.367|1.413|||Repeated measures analysis|||Interleukin 6, Week 2||1.413|0.367|0.330
73945349|NCT02799472|147423511|OTHER||Ratio|0.822||||0.519|TWO_SIDED|95.0|0.447|1.512|||Repeated measures analysis|||Interleukin 6, Week 4||1.512|0.447|0.519
73945350|NCT02799472|147423511|OTHER||Ratio|0.659||||0.147|TWO_SIDED|95.0|0.372|1.167|||Repeated measures analysis|||Interleukin 6, Week 6||1.167|0.372|0.147
73869771|NCT01620528|147283302|SUPERIORITY||Difference in LS Means|-3.23|STANDARD_ERROR_OF_MEAN|0.98||0.001|TWO_SIDED|95.0|-5.16|-1.3|||ANCOVA|||||-1.30|-5.16|0.001
73869772|NCT01620528|147283303|SUPERIORITY||Difference in LS Means|-2.02|STANDARD_ERROR_OF_MEAN|0.97||0.039|TWO_SIDED|95.0|-3.93|-0.11|||ANCOVA|||||-0.11|-3.93|0.039
73869773|NCT01620528|147283303|SUPERIORITY||Difference in LS Means|-4.86|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-6.82|-2.9|||ANCOVA|||||-2.90|-6.82|< 0.001
73945351|NCT02799472|147423511|OTHER||Ratio|0.684||||0.166|TWO_SIDED|95.0|0.396|1.18|||Repeated measures analysis|||Interleukin 6, Week 8||1.180|0.396|0.166
73945352|NCT02799472|147423511|OTHER||Ratio|1.221||||0.432|TWO_SIDED|95.0|0.734|2.031|||Repeated measures analysis|||Interleukin 6, Week 12||2.031|0.734|0.432
73945353|NCT02799472|147423511|OTHER||Ratio|1.602||||0.216|TWO_SIDED|95.0|0.75|3.423|||Repeated measures analysis|||Interleukin 6, 12-Week FU||3.423|0.750|0.216
73945354|NCT02799472|147423511|OTHER||Ratio|0.926||||0.195|TWO_SIDED|95.0|0.823|1.042|||Repeated measures analysis|||MDC, Week 1||1.042|0.823|0.195
73945355|NCT02799472|147423511|OTHER||Ratio|0.984||||0.851|TWO_SIDED|95.0|0.829|1.168|||Repeated measures analysis|||MDC, Week 2||1.168|0.829|0.851
73945356|NCT02799472|147423511|OTHER||Ratio|0.956||||0.637|TWO_SIDED|95.0|0.79|1.158|||Repeated measures analysis|||MDC, Week 4||1.158|0.790|0.637
73945357|NCT02799472|147423511|OTHER||Ratio|1.01||||0.915|TWO_SIDED|95.0|0.833|1.225|||Repeated measures analysis|||MDC, Week 6||1.225|0.833|0.915
73945358|NCT02799472|147423511|OTHER||Ratio|0.857||||0.157|TWO_SIDED|95.0|0.69|1.064|||Repeated measures analysis|||MDC, Week 8||1.064|0.690|0.157
73945359|NCT02799472|147423511|OTHER||Ratio|0.849||||0.142|TWO_SIDED|95.0|0.681|1.059|||Repeated measures analysis|||MDC, Week 12||1.059|0.681|0.142
73945360|NCT02799472|147423511|OTHER||Ratio|1.013||||0.929|TWO_SIDED|95.0|0.745|1.378|||Repeated measures analysis|||MDC, 12-Week FU||1.378|0.745|0.929
73945361|NCT02799472|147423512|OTHER||Ratio|0.887||||0.463|TWO_SIDED|95.0|0.64|1.231|||Repeated measures analysis|||Chitinase 3 Like 1, Week 1||1.231|0.640|0.463
73945362|NCT02799472|147423512|OTHER||Ratio|0.953||||0.782|TWO_SIDED|95.0|0.672|1.352|||Repeated measures analysis|||Chitinase 3 Like 1, Week 2||1.352|0.672|0.782
73945363|NCT02799472|147423512|OTHER||Ratio|1.132||||0.533|TWO_SIDED|95.0|0.759|1.69|||Repeated measures analysis|||Chitinase 3 Like 1, Week 4||1.690|0.759|0.533
73945364|NCT02799472|147423512|OTHER||Ratio|1.149||||0.473|TWO_SIDED|95.0|0.779|1.694|||Repeated measures analysis|||Chitinase 3 Like 1, Week 6||1.694|0.779|0.473
73945365|NCT02799472|147423512|OTHER||Ratio|1.112||||0.608|TWO_SIDED|95.0|0.733|1.687|||Repeated measures analysis|||Chitinase 3 Like 1, Week 8||1.687|0.733|0.608
73945366|NCT02799472|147423512|OTHER||Ratio|1.005||||0.985|TWO_SIDED|95.0|0.613|1.645|||Repeated measures analysis|||Chitinase 3 Like 1, Week 12||1.645|0.613|0.985
73945367|NCT02799472|147423512|OTHER||Ratio|1.386||||0.102|TWO_SIDED|95.0|0.934|2.057|||Repeated measures analysis|||Chitinase 3 Like 1, 12-Week FU||2.057|0.934|0.102
73945368|NCT02799472|147423512|OTHER||Ratio|0.915||||0.259|TWO_SIDED|95.0|0.781|1.071|||Repeated measures analysis|||MMP-3, Week 1||1.071|0.781|0.259
73945369|NCT02799472|147423512|OTHER||Ratio|0.959||||0.621|TWO_SIDED|95.0|0.809|1.137|||Repeated measures analysis|||MMP-3, Week 2||1.137|0.809|0.621
73945370|NCT02799472|147423512|OTHER||Ratio|0.914||||0.354|TWO_SIDED|95.0|0.752|1.11|||Repeated measures analysis|||MMP-3, Week 4||1.110|0.752|0.354
73945371|NCT02799472|147423512|OTHER||Ratio|0.8||||0.448|TWO_SIDED|95.0|0.443|1.444|||Repeated measures analysis|||MMP-3, Week 6||1.444|0.443|0.448
73945372|NCT02799472|147423512|OTHER||Ratio|1.16||||0.402|TWO_SIDED|95.0|0.813|1.653|||Repeated measures analysis|||MMP-3, Week 8||1.653|0.813|0.402
73945373|NCT02799472|147423512|OTHER||Ratio|0.951||||0.745|TWO_SIDED|95.0|0.695|1.301|||Repeated measures analysis|||MMP-3, Week 12||1.301|0.695|0.745
73945374|NCT02799472|147423512|OTHER||Ratio|1.226||||0.279|TWO_SIDED|95.0|0.837|1.796|||Repeated measures analysis|||MMP-3, 12-Week FU||1.796|0.837|0.279
73945375|NCT02799472|147423513|OTHER||Ratio|1.098||||0.621|TWO_SIDED|95.0|0.75|1.606|||Repeated measures analysis|||ARGS Neo-Epitope, Week 1||1.606|0.750|0.621
73945376|NCT02799472|147423513|OTHER||Ratio|1.581||||0.031|TWO_SIDED|95.0|1.046|2.388|||Repeated measures analysis|||ARGS Neo-Epitope, Week 2||2.388|1.046|0.031
73945377|NCT02799472|147423513|OTHER||Ratio|1.222||||0.317|TWO_SIDED|95.0|0.817|1.827|||Repeated measures analysis|||ARGS Neo-Epitope, Week 4||1.827|0.817|0.317
73945378|NCT02799472|147423513|OTHER||Ratio|1.302||||0.113|TWO_SIDED|95.0|0.936|1.81|||Repeated measures analysis|||ARGS Neo-Epitope, Week 6||1.810|0.936|0.113
73945379|NCT02799472|147423513|OTHER||Ratio|1.45||||0.217|TWO_SIDED|95.0|0.795|2.645|||Repeated measures analysis|||ARGS Neo-Epitope, Week 8||2.645|0.795|0.217
73975925|NCT03801148|147496753|EQUIVALENCE|ln-transformed- AUC0\_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infpred.|Geometric LSM ratio|1.0555|||||TWO_SIDED|90.0|1.0188|1.0935||||||||1.0935|1.0188|
73975926|NCT03801148|147496753|EQUIVALENCE|ln-transformed- AUC0\_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infpred.|Geometric LSM ratio|1.0472|||||TWO_SIDED|90.0|1.0029|1.0934||||||||1.0934|1.0029|
73945380|NCT02799472|147423513|OTHER||Ratio|1.266||||0.147|TWO_SIDED|95.0|0.916|1.75|||Repeated measures analysis|||ARGS Neo-Epitope, Week 12||1.750|0.916|0.147
73945381|NCT02799472|147423513|OTHER||Ratio|0.996||||0.985|TWO_SIDED|95.0|0.662|1.499|||Repeated measures analysis|||ARGS Neo-Epitope, 12-Week FU||1.499|0.662|0.985
73945382|NCT02799472|147423513|OTHER||Ratio|0.892||||0.681|TWO_SIDED|95.0|0.511|1.56|||Repeated measures analysis|||CMDV, Week 1||1.560|0.511|0.681
73945383|NCT02799472|147423513|OTHER||Ratio|0.87||||0.668|TWO_SIDED|95.0|0.454|1.669|||Repeated measures analysis|||CMDV, Week 2||1.669|0.454|0.668
73945384|NCT02799472|147423513|OTHER||Ratio|1.12||||0.717|TWO_SIDED|95.0|0.597|2.101|||Repeated measures analysis|||CMDV, Week 4||2.101|0.597|0.717
73945385|NCT02799472|147423513|OTHER||Ratio|0.661||||0.227|TWO_SIDED|95.0|0.333|1.31|||Repeated measures analysis|||CMDV, Week 6||1.310|0.333|0.227
73945386|NCT02799472|147423513|OTHER||Ratio|0.817||||0.471|TWO_SIDED|95.0|0.464|1.437|||Repeated measures analysis|||CMDV, Week 8||1.437|0.464|0.471
73975927|NCT01185600|147496793|SUPERIORITY_OR_OTHER|||||||0.142|||||||Fisher Exact|||||||0.142
73975928|NCT01185600|147496794|SUPERIORITY_OR_OTHER|||||||0.0391|||||||Fisher Exact|||||||0.0391
73975929|NCT01185600|147496795|SUPERIORITY_OR_OTHER|||||||0.372|||||||Fisher Exact|||||||0.372
73945387|NCT02799472|147423513|OTHER||Ratio|0.816||||0.541|TWO_SIDED|95.0|0.417|1.597|||Repeated measures analysis|||CMDV, Week 12||1.597|0.417|0.541
73945388|NCT02799472|147423513|OTHER||Ratio|0.822||||0.544|TWO_SIDED|95.0|0.422|1.602|||Repeated measures analysis|||CMDV, 12-Week FU||1.602|0.422|0.544
73945389|NCT02799472|147423513|OTHER||Ratio|1.051||||0.537|TWO_SIDED|95.0|0.895|1.233|||Repeated measures analysis|||MMP-Degraded CRP, Week 1||1.233|0.895|0.537
73945390|NCT02799472|147423513|OTHER||Ratio|1.031||||0.635|TWO_SIDED|95.0|0.906|1.173|||Repeated measures analysis|||MMP-Degraded CRP, Week 2||1.173|0.906|0.635
73945391|NCT02799472|147423513|OTHER||Ratio|1.012||||0.866|TWO_SIDED|95.0|0.879|1.165|||Repeated measures analysis|||MMP-Degraded CRP, Week 4||1.165|0.879|0.866
73945392|NCT02799472|147423513|OTHER||Ratio|0.979||||0.78|TWO_SIDED|95.0|0.842|1.139|||Repeated measures analysis|||MMP-Degraded CRP, Week 6||1.139|0.842|0.780
73945393|NCT02799472|147423513|OTHER||Ratio|1.113||||0.212|TWO_SIDED|95.0|0.938|1.32|||Repeated measures analysis|||MMP-Degraded CRP, Week 8||1.320|0.938|0.212
73945394|NCT02799472|147423513|OTHER||Ratio|1.102||||0.242|TWO_SIDED|95.0|0.934|1.3|||Repeated measures analysis|||MMP-Degraded CRP, Week 12||1.300|0.934|0.242
73945395|NCT02799472|147423513|OTHER||Ratio|1.05||||0.597|TWO_SIDED|95.0|0.87|1.267|||Repeated measures analysis|||MMP-Degraded CRP, 12-Week FU||1.267|0.870|0.597
73945396|NCT02799472|147423513|OTHER||Ratio|0.795||||0.047|TWO_SIDED|95.0|0.634|0.997|||Repeated measures analysis|||MD1C, Week 1||0.997|0.634|0.047
73945397|NCT02799472|147423513|OTHER||Ratio|0.883||||0.367|TWO_SIDED|95.0|0.668|1.165|||Repeated measures analysis|||MD1C, Week 2||1.165|0.668|0.367
73945398|NCT02799472|147423513|OTHER||Ratio|0.784||||0.155|TWO_SIDED|95.0|0.558|1.102|||Repeated measures analysis|||MD1C, Week 4||1.102|0.558|0.155
73975930|NCT01185600|147496796|SUPERIORITY_OR_OTHER|||||||0.1007|||||||t-test, 2 sided|||||||0.1007
73945399|NCT02799472|147423513|OTHER||Ratio|0.638||||0.004|TWO_SIDED|95.0|0.477|0.855|||Repeated measures analysis|||MD1C, Week 6||0.855|0.477|0.004
73945400|NCT02799472|147423513|OTHER||Ratio|0.799||||0.14|TWO_SIDED|95.0|0.591|1.08|||Repeated measures analysis|||MD1C, Week 8||1.080|0.591|0.140
73975931|NCT01185600|147496797|SUPERIORITY_OR_OTHER|||||||0.0964|||||||t-test, 2 sided|||||||0.0964
74031750|NCT00431847|147616786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6759|STANDARD_ERROR_OF_MEAN|0.391||0.0847|TWO_SIDED|95.0|-0.09297|1.4448|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.4448|-0.09297|0.0847
74031751|NCT00431847|147616787|SUPERIORITY_OR_OTHER||Slope|-0.03645|STANDARD_ERROR_OF_MEAN|0.005913|<|0.0001|TWO_SIDED|95.0|-0.04808|-0.02481|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.02481|-0.04808|<0.0001
74031752|NCT00431847|147616787|SUPERIORITY_OR_OTHER||Chi-Squared|3.16||||0.3677|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3677
73945401|NCT02799472|147423513|OTHER||Ratio|0.891||||0.47|TWO_SIDED|95.0|0.647|1.228|||Repeated measures analysis|||MD1C, Week 12||1.228|0.647|0.470
73945402|NCT02799472|147423513|OTHER||Ratio|0.869||||0.401|TWO_SIDED|95.0|0.621|1.217|||Repeated measures analysis|||MD1C, 12-Week FU||1.217|0.621|0.401
73945403|NCT02799472|147423513|OTHER||Ratio|0.981||||0.887|TWO_SIDED|95.0|0.742|1.296|||Repeated measures analysis|||MD2C, Week 1||1.296|0.742|0.887
73945404|NCT02799472|147423513|OTHER||Ratio|0.97||||0.814|TWO_SIDED|95.0|0.744|1.263|||Repeated measures analysis|||MD2C, Week 2||1.263|0.744|0.814
73945405|NCT02799472|147423513|OTHER||Ratio|0.969||||0.794|TWO_SIDED|95.0|0.762|1.233|||Repeated measures analysis|||MD2C, Week 4||1.233|0.762|0.794
73945406|NCT02799472|147423513|OTHER||Ratio|0.919||||0.539|TWO_SIDED|95.0|0.696|1.213|||Repeated measures analysis|||MD2C, Week 6||1.213|0.696|0.539
73975932|NCT01185600|147496798|SUPERIORITY_OR_OTHER|||||||0.1739|||||||t-test, 2 sided|||||||0.1739
73975933|NCT01185600|147496799|SUPERIORITY_OR_OTHER|||||||0.7205|||||||t-test, 1 sided|||||||0.7205
73975934|NCT01185600|147496800|SUPERIORITY_OR_OTHER||Negative Binomial|1.64||||0.0176|TWO_SIDED|95.0|1.06|2.55|||t-test, 2 sided||"Using Negative Binomial Regression the following ratio and corresponding 95% CI were obtained:~(# of AE's, Unwashed Group / (# of AE's, Washed Group) = 1.64 95% C.I. = \[1.06 - 2.55\]"|||2.55|1.06|0.0176
73975935|NCT05405244|147496801|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Snack intake||||0.45
73975936|NCT05405244|147496801|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Milkshake intake||||0.28
73975937|NCT05405244|147496802|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Pleasantness||||0.89
73975938|NCT05405244|147496802|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Desire to consume||||<0.001
73975939|NCT00918333|147496816|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|40.0|||||TWO_SIDED|||||||||||||
73869774|NCT01620528|147283304|SUPERIORITY||Difference in LS Means|-2.2|STANDARD_ERROR_OF_MEAN|1.03||0.032|TWO_SIDED|95.0|-4.21|-0.18|||ANCOVA|||||-0.18|-4.21|0.032
73945407|NCT02799472|147423513|OTHER||Ratio|0.937||||0.623|TWO_SIDED|95.0|0.719|1.221|||Repeated measures analysis|||MD2C, Week 8||1.221|0.719|0.623
73945408|NCT02799472|147423513|OTHER||Ratio|0.913||||0.467|TWO_SIDED|95.0|0.711|1.173|||Repeated measures analysis|||MD2C, Week 12||1.173|0.711|0.467
73945409|NCT02799472|147423513|OTHER||Ratio|0.778||||0.108|TWO_SIDED|95.0|0.57|1.061|||Repeated measures analysis|||MD2C, 12-Week FU||1.061|0.570|0.108
73945410|NCT02799472|147423513|OTHER||Ratio|1.01||||0.897|TWO_SIDED|95.0|0.868|1.175|||Repeated measures analysis|||MD3C, Week 1||1.175|0.868|0.897
73945411|NCT02799472|147423513|OTHER||Ratio|1.037||||0.644|TWO_SIDED|95.0|0.884|1.218|||Repeated measures analysis|||MD3C, Week 2||1.218|0.884|0.644
73945412|NCT02799472|147423513|OTHER||Ratio|0.943||||0.53|TWO_SIDED|95.0|0.78|1.139|||Repeated measures analysis|||MD3C, Week 4||1.139|0.780|0.530
73945413|NCT02799472|147423513|OTHER||Ratio|0.882||||0.182|TWO_SIDED|95.0|0.733|1.063|||Repeated measures analysis|||MD3C, Week 6||1.063|0.733|0.182
73945414|NCT02799472|147423513|OTHER||Ratio|0.96||||0.691|TWO_SIDED|10.0|0.779|1.182|||Repeated measures analysis|||MD3C, Week 8||1.182|0.779|0.691
73945415|NCT02799472|147423513|OTHER||Ratio|0.979||||0.843|TWO_SIDED|95.0|0.79|1.214|||Repeated measures analysis|||MD3C, Week 12||1.214|0.790|0.843
73945416|NCT02799472|147423513|OTHER||Ratio|1.075||||0.524|TWO_SIDED|95.0|0.855|1.351|||Repeated measures analysis|||MD3C, 12-Week FU||1.351|0.855|0.524
73945417|NCT02799472|147423514|OTHER||Ratio|0.953||||0.558|TWO_SIDED|95.0|0.809|1.123|||Repeated measures analysis|||Helper/Suppressor, Week 1||1.123|0.809|0.558
73945418|NCT02799472|147423514|OTHER||Ratio|0.947||||0.515|TWO_SIDED|95.0|0.801|1.12|||Repeated measures analysis|||Helper/Suppressor, Week 4||1.120|0.801|0.515
73945419|NCT02799472|147423514|OTHER||Ratio|1.046||||0.565|TWO_SIDED|95.0|0.895|1.222|||Repeated measures analysis|||Helper/Suppressor, Week 12||1.222|0.895|0.565
73945420|NCT02799472|147423514|OTHER||Ratio|1.013||||0.897|TWO_SIDED|95.0|0.822|1.249|||Repeated measures analysis|||Helper/Suppressor, 12-Week FU||1.249|0.822|0.897
73945421|NCT02799472|147423515|OTHER||Ratio|1.037||||0.786|TWO_SIDED|95.0|0.794|1.354|||Repeated measures analysis|||CD16+CD56+, Week 1||1.354|0.794|0.786
73945422|NCT02799472|147423515|OTHER||Ratio|0.818||||0.188|TWO_SIDED|95.0|0.603|1.109|||Repeated measures analysis|||CD16+CD56+, Week 4||1.109|0.603|0.188
73945423|NCT02799472|147423515|OTHER||Ratio|0.763||||0.129|TWO_SIDED|95.0|0.536|1.087|||Repeated measures analysis|||CD16+CD56+, Week 12||1.087|0.536|0.129
73945424|NCT02799472|147423515|OTHER||Ratio|0.709||||0.054|TWO_SIDED|95.0|0.499|1.006|||Repeated measures analysis|||CD16+CD56+, 12-Week FU||1.006|0.499|0.054
73945425|NCT02799472|147423515|OTHER||Ratio|1.119||||0.383|TWO_SIDED|95.0|0.863|1.45|||Repeated measures analysis|||CD19, Week 1||1.450|0.863|0.383
73945426|NCT02799472|147423515|OTHER||Ratio|0.89||||0.51|TWO_SIDED|95.0|0.623|1.271|||Repeated measures analysis|||CD19, Week 4||1.271|0.623|0.510
73945427|NCT02799472|147423515|OTHER||Ratio|0.952||||0.724|TWO_SIDED|95.0|0.718|1.262|||Repeated measures analysis|||CD19, Week 12||1.262|0.718|0.724
73945428|NCT02799472|147423515|OTHER||Ratio|0.958||||0.831|TWO_SIDED|95.0|0.635|1.443|||Repeated measures analysis|||CD19, 12-Week FU||1.443|0.635|0.831
73945429|NCT02799472|147423515|OTHER||Ratio|1.082||||0.437|TWO_SIDED|95.0|0.882|1.328|||Repeated measures analysis|||CD3, Week 1||1.328|0.882|0.437
73945430|NCT02799472|147423515|OTHER||Ratio|0.937||||0.632|TWO_SIDED|95.0|0.711|1.234|||Repeated measures analysis|||CD3, Week 4||1.234|0.711|0.632
73945431|NCT02799472|147423515|OTHER||Ratio|1.088||||0.413|TWO_SIDED|95.0|0.885|1.336|||Repeated measures analysis|||CD3, Week 12||1.336|0.885|0.413
73945432|NCT02799472|147423515|OTHER||Ratio|1.062||||0.567|TWO_SIDED|95.0|0.858|1.316|||Repeated measures analysis|||CD3, 12-Week FU||1.316|0.858|0.567
73945433|NCT02799472|147423515|OTHER||Ratio|1.069||||0.547|TWO_SIDED|95.0|0.855|1.338|||Repeated measures analysis|||CD3+CD4+, Week 1||1.338|0.855|0.547
73945434|NCT02799472|147423515|OTHER||Ratio|0.907||||0.512|TWO_SIDED|95.0|0.673|1.223|||Repeated measures analysis|||CD3+CD4+, Week 4||1.223|0.673|0.512
73975940|NCT01500200|147496832|SUPERIORITY|||||||0.014||||||Hypothesis tests were two-sided with an alpha of 0.5.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2.||||0.014
73975941|NCT01500200|147496832|SUPERIORITY|||||||0.699||||||Hypothesis tests were two-sided with an alpha of 0.05.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 8mg/8mg was compared to placebo (i.e., ALKS 5461 8mg/8mg S1 vs Placebo S1; and ALKS 5461 8mg/8mg S2 vs Placebo S2.||||0.699
73945435|NCT02799472|147423515|OTHER||Ratio|1.064||||0.573|TWO_SIDED|95.0|0.853|1.328|||Repeated measures analysis|||CD3+CD4+, Week 12||1.328|0.853|0.573
73945436|NCT02799472|147423515|OTHER||Ratio|1.031||||0.789|TWO_SIDED|95.0|0.818|1.3|||Repeated measures analysis|||CD3+CD4+, 12-Week FU||1.300|0.818|0.789
73945437|NCT02799472|147423516|OTHER||Mean Difference (Net)|0.036||||0.428|TWO_SIDED|95.0|-0.056|0.128|||Repeated measures analysis|||CD3+CD8+, Week 1||0.128|-0.056|0.428
73945438|NCT02799472|147423516|OTHER||Mean Difference (Net)|-0.023||||0.733|TWO_SIDED|95.0|-0.159|0.113|||Repeated measures analysis|||CD3+CD8+, Week 4||0.113|-0.159|0.733
73945439|NCT02799472|147423516|OTHER||Mean Difference (Net)|0.02||||0.677|TWO_SIDED|95.0|-0.076|0.115|||Repeated measures analysis|||CD3+CD8+, Week 12||0.115|-0.076|0.677
73945440|NCT02799472|147423516|OTHER||Mean Difference (Net)|0.033||||0.569|TWO_SIDED|95.0|-0.084|0.151|||Repeated measures analysis|||CD3+CD8+, 12-Week FU||0.151|-0.084|0.569
73945441|NCT02799472|147423516|OTHER||Mean Difference (Net)|0.103||||0.569|TWO_SIDED|95.0|-0.263|0.469|||Repeated measures analysis|||T Cell B Cell NKL, Week 1||0.469|-0.263|0.569
73945442|NCT02799472|147423516|OTHER||Mean Difference (Net)|-0.157||||0.534|TWO_SIDED|95.0|-0.668|0.354|||Repeated measures analysis|||T Cell B Cell NKL, Week 4||0.354|-0.668|0.534
73945443|NCT02799472|147423516|OTHER||Mean Difference (Net)|0.087||||0.668|TWO_SIDED|95.0|-0.323|0.498|||Repeated measures analysis|||T Cell B Cell NKL, Week 12||0.498|-0.323|0.668
73945444|NCT02799472|147423516|OTHER||Mean Difference (Net)|-0.021||||0.934|TWO_SIDED|95.0|-0.526|0.484|||Repeated measures analysis|||T Cell B Cell NKL, 12-Week FU||0.484|-0.526|0.934
73945445|NCT02799472|147423517|OTHER||Ratio|1.112||||0.369|TWO_SIDED|95.0|0.876|1.412|||Repeated measures analysis|||CD3+ CD4+, Week 1||1.412|0.876|0.369
73945446|NCT02799472|147423517|OTHER||Ratio|0.941||||0.641|TWO_SIDED|95.0|0.721|1.228|||Repeated measures analysis|||CD3+ CD4+, Week 4||1.228|0.721|0.641
73945447|NCT02799472|147423517|OTHER||Ratio|1.024||||0.844|TWO_SIDED|95.0|0.804|1.303|||Repeated measures analysis|||CD3+ CD4+, Week 12||1.303|0.804|0.844
73945448|NCT02799472|147423517|OTHER||Ratio|1.082||||0.558|TWO_SIDED|95.0|0.821|1.427|||Repeated measures analysis|||CD3+ CD4+, 12-Week FU||1.427|0.821|0.558
73945449|NCT02799472|147423517|OTHER||Ratio|1.111||||0.363|TWO_SIDED|95.0|0.88|1.402|||Repeated measures analysis|||CD3+ CD8+, Week 1||1.402|0.880|0.363
73945450|NCT02799472|147423517|OTHER||Ratio|0.957||||0.751|TWO_SIDED|95.0|0.724|1.265|||Repeated measures analysis|||CD3+ CD8+, Week 4||1.265|0.724|0.751
73945451|NCT02799472|147423517|OTHER||Ratio|1.076||||0.537|TWO_SIDED|95.0|0.846|1.37|||Repeated measures analysis|||CD3+ CD8+, Week 12||1.370|0.846|0.537
73945452|NCT02799472|147423517|OTHER||Ratio|1.032||||0.806|TWO_SIDED|95.0|0.797|1.335|||Repeated measures analysis|||CD3+ CD8+, 12-Week FU||1.335|0.797|0.806
73945453|NCT02799472|147423517|OTHER||Ratio|1.101||||0.405|TWO_SIDED|95.0|0.872|1.391|||Repeated measures analysis|||CD3+, Week 1||1.391|0.872|0.405
73945454|NCT02799472|147423517|OTHER||Ratio|0.907||||0.519|TWO_SIDED|95.0|0.668|1.232|||Repeated measures analysis|||CD3+, Week 4||1.232|0.668|0.519
73945455|NCT02799472|147423517|OTHER||Ratio|1.036||||0.748|TWO_SIDED|95.0|0.831|1.291|||Repeated measures analysis|||CD3+, Week 12||1.291|0.831|0.748
73945456|NCT02799472|147423517|OTHER||Ratio|1.049||||0.704|TWO_SIDED|95.0|0.811|1.356|||Repeated measures analysis|||CD3+, 12-Week FU||1.356|0.811|0.704
73945457|NCT02799472|147423518|OTHER||Mean Difference (Net)|6.5||||0.501|TWO_SIDED|95.0|-13.1|26.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 1||26.1|-13.1|0.501
73945458|NCT02799472|147423518|OTHER||Mean Difference (Net)|-1.8||||0.852|TWO_SIDED|95.0|-21.6|18.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 4||18.0|-21.6|0.852
73975942|NCT04191824|147496876|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.7769|TWO_SIDED|95.0|-2.7|2.1||In order to maintain an overall alpha of 0.05 and account for two interim analyses, a two-sided alpha of 0.0492 was used for assessing the statistical significance in the final analysis of this primary endpoint.|t-test, 2 sided|||||2.1|-2.7|0.7769
73975943|NCT04191824|147496877|SUPERIORITY||Risk Difference (RD)|0.106|||<|0.0001|TWO_SIDED|95.0|0.061|0.151|||Chi-squared|||||0.151|0.061|<0.0001
73945459|NCT02799472|147423518|OTHER||Mean Difference (Net)|6.3||||0.572|TWO_SIDED|95.0|-16.4|29.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 12||29.0|-16.4|0.572
73945460|NCT02799472|147423518|OTHER||Mean Difference (Net)|10.5||||0.363|TWO_SIDED|95.0|-13.0|34.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, 12-Week FU||34.1|-13.0|0.363
73945461|NCT02799472|147423518|OTHER||Mean Difference (Net)|2.0||||0.788|TWO_SIDED|95.0|-13.0|17.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 1||17.0|-13.0|0.788
73945462|NCT02799472|147423518|OTHER||Mean Difference (Net)|-2.2||||0.786|TWO_SIDED|95.0|-18.8|14.4|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 4||14.4|-18.8|0.786
73945463|NCT02799472|147423518|OTHER||Mean Difference (Net)|-7.1||||0.433|TWO_SIDED|95.0|-25.4|11.2|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 12||11.2|-25.4|0.433
73945464|NCT02799472|147423518|OTHER||Mean Difference (Net)|4.1||||0.55|TWO_SIDED|95.0|-9.8|18.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, 12-Week FU||18.0|-9.8|0.550
73945465|NCT02799472|147423519|OTHER||Mean Difference (Net)|14.6||||0.35|TWO_SIDED|95.0|-16.9|46.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 1||46.1|-16.9|0.350
73945466|NCT02799472|147423519|OTHER||Mean Difference (Net)|8.4||||0.697|TWO_SIDED|95.0|-35.3|52.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 4||52.0|-35.3|0.697
73945467|NCT02799472|147423519|OTHER||Mean Difference (Net)|-49.2||||0.249|TWO_SIDED|95.0|-135.2|36.8|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 12||36.8|-135.2|0.249
73945468|NCT02799472|147423519|OTHER||Mean Difference (Net)|-30.1||||0.119|TWO_SIDED|95.0|-68.6|8.3|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, 12-Week FU||8.3|-68.6|0.119
73975944|NCT04191824|147496878|SUPERIORITY||Risk Difference (RD)|0.057||||0.0753|TWO_SIDED|95.0|-0.006|0.12|||Chi-squared|||||0.120|-0.006|0.0753
73975945|NCT04191824|147496879|SUPERIORITY||Risk Difference (RD)|0.002||||0.8044|TWO_SIDED|95.0|-0.013|0.016|||Chi-squared|||||0.016|-0.013|0.8044
73975946|NCT04191824|147496880|SUPERIORITY||Risk Difference (RD)|-0.052||||0.057|TWO_SIDED|95.0|-0.105|0.002|||Chi-squared|||||0.002|-0.105|0.0570
73975947|NCT04191824|147496881|SUPERIORITY||Risk Difference (RD)|0.045||||0.0012|TWO_SIDED|95.0|0.018|0.072|||Chi-squared|||||0.072|0.018|0.0012
73975948|NCT04191824|147496882|SUPERIORITY||Risk Difference (RD)|-0.006||||0.8483|TWO_SIDED|95.0|-0.066|0.055|||Chi-squared|||||0.055|-0.066|0.8483
73945469|NCT02799472|147423519|OTHER||Mean Difference (Net)|6.5||||0.403|TWO_SIDED|95.0|-9.3|22.4|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 1||22.4|-9.3|0.403
73975949|NCT01499849|147496897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.3|2.7||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.7|1.3|<0.001
73975950|NCT01499849|147496898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.005|TWO_SIDED|95.0|1.2|2.8||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.8|1.2|0.005
73975951|NCT01499849|147496899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.001|TWO_SIDED|95.0|1.3|2.6||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.6|1.3|0.001
73945470|NCT02799472|147423519|OTHER||Mean Difference (Net)|-2.1||||0.91|TWO_SIDED|95.0|-39.4|35.2|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 4||35.2|-39.4|0.910
73945471|NCT02799472|147423519|OTHER||Mean Difference (Net)|-6.5||||0.718|TWO_SIDED|95.0|-43.1|30.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 12||30.1|-43.1|0.718
73945472|NCT02799472|147423519|OTHER||Mean Difference (Net)|-5.7||||0.687|TWO_SIDED|95.0|-34.4|23.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, 12-Week FU||23.0|-34.4|0.687
73945473|NCT02799472|147423519|OTHER||Mean Difference (Net)|-56.0||||0.559|TWO_SIDED|95.0|-249.8|137.7|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 1||137.7|-249.8|0.559
73945474|NCT02799472|147423519|OTHER||Mean Difference (Net)|51.6||||0.47|TWO_SIDED|95.0|-93.9|197.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 4||197.0|-93.9|0.470
73945475|NCT02799472|147423519|OTHER||Mean Difference (Net)|-141.5||||0.675|TWO_SIDED|95.0|-829.2|546.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 12||546.3|-829.2|0.675
73945476|NCT02799472|147423519|OTHER||Mean Difference (Net)|-137.9||||0.08|TWO_SIDED|95.0|-294.0|18.2|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, 12-Week FU||18.2|-294.0|0.080
73945477|NCT02799472|147423519|OTHER||Mean Difference (Net)|0.4||||0.989|TWO_SIDED|95.0|-60.5|61.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 1||61.3|-60.5|0.989
73945478|NCT02799472|147423519|OTHER||Mean Difference (Net)|-17.4||||0.634|TWO_SIDED|95.0|-94.3|59.6|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 4||59.6|-94.3|0.634
73945479|NCT02799472|147423519|OTHER||Mean Difference (Net)|59.4||||0.789|TWO_SIDED|95.0|-395.2|513.9|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 12||513.9|-395.2|0.789
73945480|NCT02799472|147423519|OTHER||Mean Difference (Net)|-47.2||||0.249|TWO_SIDED|95.0|-135.5|41.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, 12-Week FU||41.0|-135.5|0.249
73945481|NCT02799472|147423519|OTHER||Mean Difference (Net)|3682.3||||0.234|TWO_SIDED|95.0|-2511.9|9876.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 1||9876.5|-2511.9|0.234
73945482|NCT02799472|147423519|OTHER||Mean Difference (Net)|-547.6||||0.875|TWO_SIDED|95.0|-7612.6|6517.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 4||6517.3|-7612.6|0.875
73869775|NCT01620528|147283304|SUPERIORITY||Difference in LS Means|-4.91|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-6.95|-2.86|||ANCOVA|||||-2.86|-6.95|< 0.001
73945483|NCT02799472|147423519|OTHER||Mean Difference (Net)|-1106.0||||0.815|TWO_SIDED|95.0|-10706.0|8494.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 12||8494.1|-10706.0|0.815
73945484|NCT02799472|147423519|OTHER||Mean Difference (Net)|-3631.0||||0.23|TWO_SIDED|95.0|-9738.9|2476.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, 12-Week FU||2476.8|-9738.9|0.230
73945485|NCT02799472|147423519|OTHER||Mean Difference (Net)|-515.6||||0.489|TWO_SIDED|95.0|-2021.4|990.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 1||990.1|-2021.4|0.489
73945486|NCT02799472|147423519|OTHER||Mean Difference (Net)|-199.8||||0.822|TWO_SIDED|95.0|-2001.7|1602.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 4||1602.0|-2001.7|0.822
73945487|NCT02799472|147423519|OTHER||Mean Difference (Net)|-253.5||||0.784|TWO_SIDED|95.0|-2136.7|1629.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 12||1629.7|-2136.7|0.784
73945488|NCT02799472|147423519|OTHER||Mean Difference (Net)|225.1||||0.804|TWO_SIDED|95.0|-1633.1|2083.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, 12-Week FU||2083.2|-1633.1|0.804
73945489|NCT02799472|147423519|OTHER||Mean Difference (Net)|162.7||||0.719|TWO_SIDED|95.0|-754.5|1079.9|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 1||1079.9|-754.5|0.719
73945490|NCT02799472|147423519|OTHER||Mean Difference (Net)|-183.5||||0.742|TWO_SIDED|95.0|-1317.4|950.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 4||950.3|-1317.4|0.742
73945491|NCT02799472|147423519|OTHER||Mean Difference (Net)|-268.5||||0.658|TWO_SIDED|95.0|-1507.5|970.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 12||970.5|-1507.5|0.658
73945492|NCT02799472|147423519|OTHER||Mean Difference (Net)|-197.6||||0.755|TWO_SIDED|95.0|-1499.3|1104.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, 12-Week FU||1104.2|-1499.3|0.755
73945493|NCT02799472|147423519|OTHER||Mean Difference (Net)|1150.0||||0.333|TWO_SIDED|95.0|-1250.0|3550.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 1||3550.0|-1250.0|0.333
73945494|NCT02799472|147423519|OTHER||Mean Difference (Net)|-268.0||||0.891|TWO_SIDED|95.0|-4269.2|3733.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 4||3733.3|-4269.2|0.891
73975952|NCT00174252|147496901|SUPERIORITY_OR_OTHER||Percentage|86.0|||||TWO_SIDED|95.0|74.2|93.7|||||95% CI was estimated using the F-distribution.|"Applies to no."||93.7|74.2|
73975953|NCT00174252|147496901|SUPERIORITY_OR_OTHER||Percentage|14.0||||||95.0|6.3|25.8|||||95% confidence interval (CI) was estimated using the F-distribution.|"Applies to yes."||25.8|6.3|
73975954|NCT00174252|147496915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.002||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.002
73975955|NCT00174252|147496916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.023||95.0||||Bilateral test multiple comparison threshold for statistical significance = 0.05|ANCOVA|Adjusted for height SD at baseline.||||||0.023
73975956|NCT00174252|147496917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.708||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.708
73975957|NCT00174252|147496918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.325||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.325
73975958|NCT03611556|147496945|SUPERIORITY||Rate difference|-8.0||||0.3614|TWO_SIDED|95.0|-27.6|12.1||Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by cluster of differentiation 73 (CD73) level.|Cochran-Mantel-Haenszel||||80% Confidence Interval 2-Sided: -20.9 to 5.2|12.1|-27.6|0.3614
73945495|NCT02799472|147423519|OTHER||Mean Difference (Net)|-1347.4||||0.633|TWO_SIDED|95.0|-7073.1|4378.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 12||4378.3|-7073.1|0.633
73945496|NCT02799472|147423519|OTHER||Mean Difference (Net)|-1688.9||||0.41|TWO_SIDED|95.0|-5864.1|2486.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, 12-Week FU||2486.2|-5864.1|0.410
73945497|NCT02799472|147423519|OTHER||Mean Difference (Net)|3276.8||||0.196|TWO_SIDED|95.0|-1786.0|8339.6|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 1||8339.6|-1786.0|0.196
73945498|NCT02799472|147423519|OTHER||Mean Difference (Net)|-447.3||||0.894|TWO_SIDED|95.0|-7285.5|6390.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 4||6390.8|-7285.5|0.894
73945499|NCT02799472|147423519|OTHER||Mean Difference (Net)|1435.3||||0.6|TWO_SIDED|95.0|-4101.4|6972.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 12||6972.0|-4101.4|0.600
73945500|NCT02799472|147423519|OTHER||Mean Difference (Net)|-1210.2||||0.534|TWO_SIDED|95.0|-5213.1|2792.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, 12-Week FU||2792.7|-5213.1|0.534
73945501|NCT02799472|147423520|OTHER||Mean Difference (Net)|2756.3||||0.328|TWO_SIDED|95.0|-2953.7|8466.3|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 1||8466.3|-2953.7|0.328
73945502|NCT02799472|147423520|OTHER||Mean Difference (Net)|-487.5||||0.895|TWO_SIDED|95.0|-8003.7|7028.6|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 4||7028.6|-8003.7|0.895
73945503|NCT02799472|147423520|OTHER||Mean Difference (Net)|-277.4||||0.961|TWO_SIDED|95.0|-12001.0|11446.2|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 12||11446.2|-12001.0|0.961
73945504|NCT02799472|147423520|OTHER||Mean Difference (Net)|-311.6||||0.956|TWO_SIDED|95.0|-11960.5|11337.4|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, 12-Week FU||11337.4|-11960.5|0.956
73945505|NCT02799472|147423520|OTHER||Mean Difference (Net)|6866.9||||0.212|TWO_SIDED|95.0|-4230.7|17964.6|||Repeated measures analysis|||CD14br+CD16+, Week 1||17964.6|-4230.7|0.212
73945506|NCT02799472|147423520|OTHER||Mean Difference (Net)|8359.6||||0.227|TWO_SIDED|95.0|-5533.3|22252.5|||Repeated measures analysis|||CD14br+CD16+, Week 4||22252.5|-5533.3|0.227
73945507|NCT02799472|147423520|OTHER||Mean Difference (Net)|-22683.6||||0.04|TWO_SIDED|95.0|-44298.5|-1068.8|||Repeated measures analysis|||CD14br+CD16+, Week 12||-1068.8|-44298.5|0.040
73945508|NCT02799472|147423520|OTHER||Mean Difference (Net)|-3757.2||||0.741|TWO_SIDED|95.0|-27146.0|19631.6|||Repeated measures analysis|||CD14br+CD16+, 12-Week FU||19631.6|-27146.0|0.741
73945509|NCT02799472|147423520|OTHER||Mean Difference (Net)|-22417.0||||0.628|TWO_SIDED|95.0|-116677.8|71843.8|||Repeated measures analysis|||CD14br+CD16-, Week 1||71843.8|-116677.8|0.628
73869776|NCT01620528|147283305|SUPERIORITY||Difference in LS Means|-2.42|STANDARD_ERROR_OF_MEAN|0.94||0.01|TWO_SIDED|95.0|-4.26|-0.58|||ANCOVA|||||-0.58|-4.26|0.010
73945510|NCT02799472|147423520|OTHER||Mean Difference (Net)|27659.7||||0.321|TWO_SIDED|95.0|-28567.8|83887.1|||Repeated measures analysis|||CD14br+CD16-, Week 4||83887.1|-28567.8|0.321
73945511|NCT02799472|147423520|OTHER||Mean Difference (Net)|16182.9||||0.704|TWO_SIDED|95.0|-70377.0|102742.9|||Repeated measures analysis|||CD14br+CD16-, Week 12||102742.9|-70377.0|0.704
73945512|NCT02799472|147423520|OTHER||Mean Difference (Net)|-63419.4||||0.232|TWO_SIDED|95.0|-170364.9|43526.1|||Repeated measures analysis|||CD14br+CD16-, 12-Week FU||43526.1|-170364.9|0.232
73945513|NCT02799472|147423520|OTHER||Mean Difference (Net)|-6913.6||||0.366|TWO_SIDED|95.0|-22588.4|8761.1|||Repeated measures analysis|||CD14lo+CD16br+, Week 1||8761.1|-22588.4|0.366
73945514|NCT02799472|147423520|OTHER||Mean Difference (Net)|-2231.6||||0.603|TWO_SIDED|95.0|-10976.8|6513.6|||Repeated measures analysis|||CD14lo+CD16br+, Week 4||6513.6|-10976.8|0.603
73945515|NCT02799472|147423520|OTHER||Mean Difference (Net)|-10179.1||||0.084|TWO_SIDED|95.0|-21827.4|1469.2|||Repeated measures analysis|||CD14lo+CD16br+, Week 12||1469.2|-21827.4|0.084
73945516|NCT02799472|147423520|OTHER||Mean Difference (Net)|-20744.2||||0.026|TWO_SIDED|95.0|-38771.8|-2716.5|||Repeated measures analysis|||CD14lo+CD16br+, 12-Week FU||-2716.5|-38771.8|0.026
73945517|NCT02799472|147423521|OTHER||Mean Difference (Net)|178.2||||0.564|TWO_SIDED|95.0|-448.3|804.6|||Repeated measures analysis|||Week 1||804.6|-448.3|0.564
73945518|NCT02799472|147423521|OTHER||Mean Difference (Net)|540.4||||0.216|TWO_SIDED|95.0|-335.7|1416.5|||Repeated measures analysis|||Week 4||1416.5|-335.7|0.216
73945519|NCT02799472|147423521|OTHER||Mean Difference (Net)|-252.6||||0.629|TWO_SIDED|95.0|-1326.0|820.8|||Repeated measures analysis|||Week 12||820.8|-1326.0|0.629
73975959|NCT03611556|147496945|SUPERIORITY||Rate difference|3.8||||0.6503|TWO_SIDED|95.0|-13.2|20.7||Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by CD73 level.|Cochran-Mantel-Haenszel||||80% Confidence Interval 2-Sided: -7.4 to 15.0|20.7|-13.2|0.6503
73975960|NCT03611556|147496952|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.79|1.983|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.983|0.790|
73975961|NCT03611556|147496952|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.498|1.131|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.131|0.498|
73975962|NCT03611556|147496954|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.726|1.837|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.837|0.726|
73945520|NCT02799472|147423521|OTHER||Mean Difference (Net)|41.6||||0.932|TWO_SIDED|95.0|-962.2|1045.5|||Repeated measures analysis|||12-Week FU||1045.5|-962.2|0.932
73975963|NCT03611556|147496954|SUPERIORITY||Hazard Ratio (HR)|0.719|||||TWO_SIDED|95.0|0.468|1.105|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.105|0.468|
73975964|NCT03611556|147496958|SUPERIORITY||Rate difference|-1.7|||||TWO_SIDED|95.0|-25.2|21.9||||||||21.9|-25.2|
73975965|NCT03611556|147496958|SUPERIORITY||Rate difference|7.5|||||TWO_SIDED|95.0|-12.6|27.0||||||||27.0|-12.6|
73975966|NCT03611556|147496958|SUPERIORITY||Rate difference|-25.6|||||TWO_SIDED|95.0|-58.3|13.9||||||||13.9|-58.3|
73869777|NCT01620528|147283305|SUPERIORITY||Difference in LS Means|-5.25|STANDARD_ERROR_OF_MEAN|0.96|<|0.001|TWO_SIDED|95.0|-7.14|-3.36|||ANCOVA|||||-3.36|-7.14|< 0.001
73869778|NCT01620528|147283306|SUPERIORITY||Difference in LS Means|-1.17|STANDARD_ERROR_OF_MEAN|0.94||0.215|TWO_SIDED|95.0|-3.02|0.68|||ANCOVA|||||0.68|-3.02|0.215
73945521|NCT02799472|147423529|OTHER||Median Difference (Net)|-0.13||||0.547|TWO_SIDED|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference \<0||2.23|-2.32|0.547
73945522|NCT02799472|147423529|OTHER||Median Difference (Net)|-2.18||||0.948|TWO_SIDED|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference \<0||0.51|-4.77|0.948
73945523|NCT02799472|147423529|OTHER||Median Difference (Net)|-2.28||||0.949|TWO_SIDED|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference \<0||0.45|-5.02|0.949
73945524|NCT02799472|147423529|OTHER||Median Difference (Net)|-0.13||||0.453|TWO_SIDED|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference \>0||2.23|-2.32|0.453
73945525|NCT02799472|147423529|OTHER||Median Difference (Net)|-2.18||||0.052|TWO_SIDED|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference \>0||0.51|-4.77|0.052
73945526|NCT02799472|147423529|OTHER||Median Difference (Net)|-2.28||||0.051|TWO_SIDED|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference \>0||0.45|-5.02|0.051
73945527|NCT02799472|147423530|OTHER||Mean Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-0.2|0.3|||Repeated measures analysis|||Week 4||0.3|-0.2|0.940
73945528|NCT02799472|147423530|OTHER||Mean Difference (Net)|-0.8||||0.521|TWO_SIDED|95.0|-3.2|1.6|||Repeated measures analysis|||Week 12||1.6|-3.2|0.521
73945529|NCT02799472|147423530|OTHER||Mean Difference (Net)|-1.3||||0.396|TWO_SIDED|95.0|-4.4|1.8|||Repeated measures analysis|||12-Week FU||1.8|-4.4|0.396
73945530|NCT02799472|147423531|OTHER||Mean Difference (Net)|0.0||||0.945|TWO_SIDED|95.0|-1.1|1.2|||Repeated measures analysis|||Week 4||1.2|-1.1|0.945
73945531|NCT02799472|147423531|OTHER||Mean Difference (Net)|-0.4||||0.475|TWO_SIDED|95.0|-1.5|0.7|||Repeated measures analysis|||Week 12||0.7|-1.5|0.475
73945532|NCT02799472|147423531|OTHER||Mean Difference (Net)|-0.9||||0.086|TWO_SIDED|95.0|-2.0|0.1|||Repeated measures analysis|||12-Week FU||0.1|-2.0|0.086
73945533|NCT02799472|147423532|OTHER||Mean Difference (Net)|211.4||||0.874|TWO_SIDED|95.0|-2589.2|3012.0|||Repeated measures analysis|||Week 4||3012.0|-2589.2|0.874
73945534|NCT02799472|147423532|OTHER||Mean Difference (Net)|-504.8||||0.749|TWO_SIDED|95.0|-3730.4|2720.9|||Repeated measures analysis|||Week 12||2720.9|-3730.4|0.749
73945535|NCT02799472|147423532|OTHER||Mean Difference (Net)|-1536.0||||0.352|TWO_SIDED|95.0|-4884.2|1812.1|||Repeated measures analysis|||12-Week FU||1812.1|-4884.2|0.352
73945536|NCT02799472|147423533|OTHER||Mean Difference (Net)|0.0128||||0.291|TWO_SIDED|95.0|-0.0123|0.038|||Repeated measures analysis|||Week 4||0.0380|-0.0123|0.291
73945537|NCT02799472|147423533|OTHER||Mean Difference (Net)|0.0036||||0.375|TWO_SIDED|95.0|-0.0046|0.0118|||Repeated measures analysis|||Week 12||0.0118|-0.0046|0.375
73945538|NCT02799472|147423533|OTHER||Mean Difference (Net)|0.001||||0.588|TWO_SIDED|95.0|-0.0028|0.0049|||Repeated measures analysis|||12-Week FU||0.0049|-0.0028|0.588
73945539|NCT02799472|147423534|OTHER||Mean Difference (Net)|-0.0002||||0.915|TWO_SIDED|95.0|-0.0033|0.0029|||Repeated measures analysis|||Week 4||0.0029|-0.0033|0.915
73945540|NCT02799472|147423534|OTHER||Mean Difference (Net)|-0.0004||||0.771|TWO_SIDED|95.0|-0.0028|0.0021|||Repeated measures analysis|||Week 12||0.0021|-0.0028|0.771
73945541|NCT02799472|147423534|OTHER||Mean Difference (Net)|0.0005||||0.85|TWO_SIDED|95.0|-0.0048|0.0058|||Repeated measures analysis|||12-Week FU||0.0058|-0.0048|0.850
73945542|NCT02801669|147423535|OTHER||Cox Proportional Hazard|0.339||||0.0003|TWO_SIDED|95.0|0.188|0.608|||Regression, Cox|The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.||This statistical analysis assesses the annual incidence of composite event of stroke and SEE between treatment groups.||0.608|0.188|0.0003
73945543|NCT02801669|147423536|OTHER||Cox Proportional Hazard|0.299|||||TWO_SIDED|95.0|0.157|0.57|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of stroke between treatment groups.||0.570|0.157|
73945544|NCT02801669|147423536|OTHER||Cox Proportional Hazard|0.503|||||TWO_SIDED|95.0|0.126|2.011|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of SEE between treatment groups.||2.011|0.126|
73945545|NCT02801669|147423536|OTHER||Cox Proportional Hazard|0.306|||||TWO_SIDED|95.0|0.16|0.585|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of ischemic stroke between treatment groups.||0.585|0.160|
73945546|NCT02801669|147423536|OTHER||Cox Proportional Hazard|0.347|||||TWO_SIDED|95.0|0.193|0.624|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of ischemic stroke/SEE between treatment groups.||0.624|0.193|
73945547|NCT03315936|147423559|OTHER||geometric mean (gMean) ratio (T/R) %|110.31|||||TWO_SIDED|90.0|100.73|120.79|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 12.3.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually 12 subjects were analyzed||120.79|100.73|
73975967|NCT03611556|147496958|SUPERIORITY||Rate difference|-6.9|||||TWO_SIDED|95.0|-39.1|26.6||||||||26.6|-39.1|
73975968|NCT03611556|147496959|SUPERIORITY||Hazard Ratio (HR)|1.173|||||TWO_SIDED|95.0|0.676|1.985|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||1.985|0.676|
73975969|NCT03611556|147496959|SUPERIORITY||Hazard Ratio (HR)|0.605|||||TWO_SIDED|95.0|0.377|0.968|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||0.968|0.377|
73869779|NCT01620528|147283306|SUPERIORITY||Difference in LS Means|-5.13|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|-7.06|-3.2|||ANCOVA|||||-3.20|-7.06|< 0.001
73975970|NCT03611556|147496959|SUPERIORITY||Hazard Ratio (HR)|1.549|||||TWO_SIDED|95.0|0.622|3.917|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.917|0.622|
73975971|NCT03611556|147496959|SUPERIORITY||Hazard Ratio (HR)|1.472|||||TWO_SIDED|95.0|0.638|3.576|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.576|0.638|
73975972|NCT03611556|147496961|SUPERIORITY||Hazard Ratio (HR)|1.004|||||TWO_SIDED|95.0|0.584|1.693|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||1.693|0.584|
73975973|NCT03611556|147496961|SUPERIORITY||Hazard Ratio (HR)|0.598|||||TWO_SIDED|95.0|0.366|0.973|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||0.973|0.366|
73975974|NCT03611556|147496961|SUPERIORITY||Hazard Ratio (HR)|1.933|||||TWO_SIDED|95.0|0.716|5.437|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||5.437|0.716|
73869780|NCT01620528|147283307|SUPERIORITY||Difference in LS Means|-2.25|STANDARD_ERROR_OF_MEAN|1.16||0.053|TWO_SIDED|95.0|-4.53|0.03|||ANCOVA|||||0.03|-4.53|0.053
73869781|NCT01620528|147283307|SUPERIORITY||Difference in LS Means|-6.79|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-9.17|-4.41|||ANCOVA|||||-4.41|-9.17|< 0.001
73945548|NCT03315936|147423560|OTHER||gMean ratio (T/R) %|110.83|||||TWO_SIDED|90.0|101.2|121.38|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 12.3.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||121.38|101.20|
73945549|NCT03315936|147423561|OTHER||gMean ratio (T/R) %|110.46|||||TWO_SIDED|90.0|89.74|135.96|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 28.6.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||135.96|89.74|
73945550|NCT03541044|147423604|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 - 1.25 range.|Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.91|1.0|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)|||1.00|0.91|
73945551|NCT03541044|147423605|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC(0-inf) fell completely within the 0.80 - 1.25 range.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.00|0.89|
73945552|NCT03541044|147423606|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the 0.80 - 1.25 range.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.82|0.98|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||0.98|0.82|
73945553|NCT00860067|147423619|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV A/H1N1.|Ratio of geometric mean|1.09|||||TWO_SIDED|95.0|1.01|1.18|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||A/H1N1: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.18|1.01|
73945554|NCT00860067|147423619|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV A/H3N2.|Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.96|1.14|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||A/H3N2: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.14|0.96|
73945555|NCT00860067|147423619|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: (FluMist B/Yamagata) divided by (Q/LAIV B/Yamagata).|Ratio of geometric mean|1.1|||||TWO_SIDED|95.0|0.97|1.25|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.25|0.97|
73945556|NCT00860067|147423619|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: (FluMist B/Victoria) divided by (Q/LAIV B/Victoria).|Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.82|1.03|||Bootstrapping|Confidence intervals were calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.03|0.82|
73945557|NCT00560612|147423643|SUPERIORITY|||||||0.7054|||||||t-test, 2 sided|||||||0.7054
73945558|NCT00560612|147423644|SUPERIORITY|||||||0.4583|||||||t-test, 2 sided|||||||0.4583
73945559|NCT00560612|147423645|SUPERIORITY|||||||0.7443|||||||t-test, 2 sided|||||||0.7443
73945560|NCT00560612|147423646|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
73945561|NCT02424591|147423651|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
73945562|NCT02424591|147423652|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
73945563|NCT02424591|147423653|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
73975975|NCT03611556|147496961|SUPERIORITY||Hazard Ratio (HR)|1.374|||||TWO_SIDED|95.0|0.55|3.707|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.707|0.550|
73975976|NCT02397096|147496971|NON_INFERIORITY|Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) once daily (QD) ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-3.784|||||TWO_SIDED|95.0|-7.877|0.31|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).|0.310|-7.877|
73975977|NCT02397096|147496972|OTHER||Treatment Difference|-14.65|||<|0.0001|TWO_SIDED|95.0|-18.92|-10.38|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.|||-10.38|-18.92|<0.0001
73869782|NCT01620528|147283308|SUPERIORITY||Difference in LS Means|-2.12|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.24|-1.01|||ANCOVA|||||-1.01|-3.24|< 0.001
73975978|NCT02397096|147496973|OTHER||Treatment Difference|-23.03|||<|0.0001|TWO_SIDED|95.0|-28.0|-18.05|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.|||-18.05|-28.00|<0.0001
73869783|NCT01620528|147283308|SUPERIORITY||Difference in LS Means|-2.6|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.71|-1.49|||ANCOVA|||||-1.49|-3.71|< 0.001
73869784|NCT01620528|147283309|SUPERIORITY||Difference in LS Means|-2.09|STANDARD_ERROR_OF_MEAN|0.67||0.002|TWO_SIDED|95.0|-3.4|-0.78|||ANCOVA|||||-0.78|-3.40|0.002
73945564|NCT01498822|147423658|NON_INFERIORITY_OR_EQUIVALENCE|The primary analysis of this study aimed to demonstrate that LEV was noninferior to OXC with respect to the treatment failure rate in the Per Protocol Set. The noninferiority margin was 15 %.|Absolut difference|-10.7|||||TWO_SIDED|95.0|-20.2|-1.2|||Wald methodology||"Absolute difference in treatment failure rates of LEV versus OXC is defined as Treatment Failure Rate LEV minus Treatment Failure Rate OXC."|||-1.2|-20.2|
73945565|NCT04037436|147423671|OTHER|GEE|GEE|1.65||||0.05|TWO_SIDED|95.0|-4.44|7.73|||GEE|To model the interaction between exposure to the MoveStrong program and site on secondary outcomes we applied a generalized estimating equation (GEE).||To model the interaction between exposure to the MoveStrong program and site on secondary outcomes we applied a generalized estimating equation (GEE).||7.73|-4.44|0.05
73945566|NCT01674621|147423674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0066||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0066
73945567|NCT01674621|147423674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0005
73945568|NCT01674621|147423674|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||<0.0001
73945569|NCT01674621|147423674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.93|||||TWO_SIDED|95.0|-5.555|-2.305|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-2.305|-5.555|
73945570|NCT01674621|147423674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.47|||||TWO_SIDED|95.0|-5.104|-1.837|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-1.837|-5.104|
73945571|NCT01674621|147423674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.856|||||TWO_SIDED|95.0|-4.519|-1.193|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-1.193|-4.519|
73945572|NCT01674621|147423675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0547||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0547
73945573|NCT01674621|147423675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0056
73975979|NCT02397096|147496974|NON_INFERIORITY|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-0.877|||||TWO_SIDED|95.0|-4.706|2.952|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).|2.952|-4.706|
73975980|NCT02397096|147496975|OTHER||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-31.6|23.5|||||95% CIs were calculated based on t-distribution.|||23.5|-31.6|
73975981|NCT02397096|147496976|SUPERIORITY||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-41.1|15.4|||||95% Confidence Intervals were based on t-distribution.|||15.4|-41.1|
73975982|NCT02397096|147496977|OTHER||Treatment Difference|-3.556|||||TWO_SIDED|95.0|-7.977|0.864|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||0.864|-7.977|
73975983|NCT02397096|147496978|OTHER||Treatment Difference|-0.427|||||TWO_SIDED|95.0|-4.591|3.738|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||3.738|-4.591|
73975984|NCT02397096|147496979|NON_INFERIORITY|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -4 percentage points.|Treatment Difference|-0.232|||||TWO_SIDED|95.0|-2.529|2.064|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||2.064|-2.529|
73975985|NCT02392234|147496983|SUPERIORITY||Least Squares (LS) Mean Difference|4.7|||<|0.0001|TWO_SIDED|95.0|3.7|5.8|||Linear Mixed Effects Model|||||5.8|3.7|< 0.0001
73975986|NCT02392234|147496983|SUPERIORITY||LS Mean Difference|6.8|||<|0.0001|TWO_SIDED|95.0|5.7|7.8|||Linear Mixed Effects Model|||||7.8|5.7|< 0.0001
73975987|NCT02392234|147496984|SUPERIORITY||LS Mean Difference|9.7|||<|0.0001|TWO_SIDED|95.0|7.2|12.2|||Linear Mixed Effects Model|||||12.2|7.2|<0.0001
73945574|NCT01674621|147423675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0018
73975988|NCT02392234|147496984|SUPERIORITY||LS Mean Difference|11.1|||<|0.0001|TWO_SIDED|95.0|8.7|13.6|||Linear Mixed Effects Model|||||13.6|8.7|<0.0001
73975989|NCT02392234|147496986|SUPERIORITY||LS Mean Difference|8.1|||<|0.0001|TWO_SIDED|95.0|6.3|9.9|||Linear Mixed Effects Model|||||9.9|6.3|<0.0001
73975990|NCT02392234|147496986|SUPERIORITY||LS Mean Difference|11.4|||<|0.0001|TWO_SIDED|95.0|9.6|13.2|||Linear Mixed Effects Model|||||13.2|9.6|<0.0001
73975991|NCT02392234|147496987|SUPERIORITY||LS Mean Difference|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.7|-2.3|||Linear Mixed Effects Model|||||-2.3|-6.7|<0.0001
73945575|NCT01674621|147423675|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.768|||||TWO_SIDED|95.0|-2.864|-0.672|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-0.672|-2.864|
73945576|NCT01674621|147423675|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.42|||||TWO_SIDED|95.0|-2.522|-0.318|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-0.318|-2.522|
73945577|NCT01674621|147423675|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.247|||||TWO_SIDED|95.0|-2.368|-0.126|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-0.126|-2.368|
73945578|NCT01674621|147423676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9493||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.9493
73945579|NCT01674621|147423676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9806||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.9806
73945580|NCT01674621|147423676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5191||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.5191
73945581|NCT01674621|147423676|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.564|||||TWO_SIDED|95.0|-2.168|1.04|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||1.040|-2.168|
73945582|NCT01674621|147423676|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.483|||||TWO_SIDED|95.0|-2.115|1.15|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||1.150|-2.115|
73945583|NCT01674621|147423676|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.517|||||TWO_SIDED|95.0|-1.106|2.139|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||2.139|-1.106|
73945584|NCT01674621|147423677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2549||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.2549
73945585|NCT01674621|147423677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9115||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.9115
73945586|NCT01674621|147423677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.239||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.2390
73945587|NCT01674621|147423677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.146|||||TWO_SIDED|95.0|-40.501|-3.79|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-3.790|-40.501|
73945588|NCT01674621|147423677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.086|||||TWO_SIDED|95.0|-30.543|6.372|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||6.372|-30.543|
73945589|NCT01674621|147423677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.828|||||TWO_SIDED|95.0|-41.614|-4.041|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-4.041|-41.614|
73945590|NCT01674621|147423678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1632||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.1632
73945591|NCT01674621|147423678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9834||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.9834
73945592|NCT01674621|147423678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2179||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment (EOT) to each transdermal dose group versus placebo.||||||0.2179
73945593|NCT01674621|147423678|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.541|||||TWO_SIDED|95.0|-48.557|-6.525|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-6.525|-48.557|
73975992|NCT02392234|147496987|SUPERIORITY||LS Mean Difference|-9.5|||<|0.0001|TWO_SIDED|95.0|-11.7|-7.3|||Linear Mixed Effects Model|||||-7.3|-11.7|<0.0001
74089249|NCT02697773|147731607|SUPERIORITY||Least Mean Square Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.21||0.0004|TWO_SIDED|95.0|-1.17|-0.34|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.34|-1.17|0.0004
73945594|NCT01674621|147423678|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.702|||||TWO_SIDED|95.0|-39.835|2.43|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||2.430|-39.835|
73945595|NCT01674621|147423678|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.914|||||TWO_SIDED|95.0|-48.424|-5.405|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-5.405|-48.424|
73975993|NCT05890794|147497008|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|40.85||||0.0005|TWO_SIDED|95.0|22.842|58.858||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PPi.||58.858|22.842|0.0005
73945596|NCT01674621|147423679|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||1.0000
73945597|NCT01674621|147423679|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||0.1200
73945598|NCT01674621|147423679|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9998||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||0.9998
73945599|NCT01674621|147423679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-73.906|||||TWO_SIDED|95.0|-96.926|-50.886|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-50.886|-96.926|
73945600|NCT01674621|147423679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-62.872|||||TWO_SIDED|95.0|-86.019|-39.725|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-39.725|-86.019|
73945601|NCT01674621|147423679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-73.367|||||TWO_SIDED|95.0|-96.927|-49.807|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-49.807|-96.927|
73945602|NCT01674621|147423680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8569||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.8569
73945603|NCT01674621|147423680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6091||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.6091
73945604|NCT01674621|147423680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9999||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to EOT to each transdermal dose group versus placebo.||||||0.9999
73945605|NCT01674621|147423680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-110.398|||||TWO_SIDED|95.0|-156.966|-63.831|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-63.831|-156.966|
73945606|NCT01674621|147423680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-96.115|||||TWO_SIDED|95.0|-142.94|-49.29|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-49.290|-142.940|
73945607|NCT01674621|147423680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-104.418|||||TWO_SIDED|95.0|-152.079|-56.758|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-56.758|-152.079|
73945608|NCT01674621|147423681|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3483||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.3483
73945609|NCT01674621|147423681|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6839||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.6839
73945610|NCT01674621|147423681|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1067||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.1067
73945611|NCT01674621|147423681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-43.721|||||TWO_SIDED|95.0|-75.748|-11.694|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-11.694|-75.748|
73945612|NCT01674621|147423681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.461|||||TWO_SIDED|95.0|-71.665|-7.257|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-7.257|-71.665|
73945613|NCT01674621|147423681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.334|||||TWO_SIDED|95.0|-82.113|-16.555|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-16.555|-82.113|
73945614|NCT01148862|147423697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.2||||0.006|||||||ANCOVA|||||||0.006
73945615|NCT01148862|147423698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.015||95.0|||||ANCOVA|||||||0.015
73945616|NCT00125593|147423706|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.0021|TWO_SIDED|95.0|0.74|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.74|0.0021
73945617|NCT00125593|147423707|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.0012|TWO_SIDED|95.0|0.77|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.77|0.0012
73945618|NCT00125593|147423708|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.001|TWO_SIDED|95.0|0.75|0.93|||Log Rank|||All analyses by intention to treat||0.93|0.75|0.001
73945619|NCT00125593|147423709|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.37|TWO_SIDED|95.0|0.76|1.11|||Log Rank|||All analyses by intention to treat||1.11|0.76|0.37
73945620|NCT00125593|147423710|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.01|TWO_SIDED|95.0|0.6|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.60|0.01
73975994|NCT05890794|147497008|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error|Difference in LS Means|-11.17|STANDARD_ERROR_OF_MEAN|2.681|<|0.0001|TWO_SIDED|95.0|-16.52|-5.82||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by a mixed model repeated measures (MMRM) analysis for PPi.||-5.82|-16.52|<0.0001
73975995|NCT05890794|147497009|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|30.89|||<|0.0001|TWO_SIDED|95.0|20.831|40.941||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PLP.||40.941|20.831|<0.0001
73945621|NCT00125593|147423711|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.0036|TWO_SIDED|95.0|0.68|0.93|||Log Rank|||All analyses by intention to treat||0.93|0.68|0.0036
73945622|NCT00125593|147423712|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97||||0.41|TWO_SIDED|95.0|0.89|1.05|||Log Rank|||All analyses by intention to treat||1.05|0.89|0.41
73945623|NCT01597505|147423713|NON_INFERIORITY|Surotomycin minus Vancomycin. For surotomycin to be non-inferior to vancomycin the lower bound of a 2-sided 95% CI for the difference between treatment groups had to be ≥ -10%.|Difference in percentage of participants|-4.6|||||TWO_SIDED|95.0|-11.0|1.9|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in percentage of participants||1.9|-11.0|
73945624|NCT01597505|147423714|SUPERIORITY|||||||0.832||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified log-rank test p-value||||0.832
73945625|NCT01597505|147423715|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-0.8|||||TWO_SIDED|95.0|-8.8|7.1|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||7.1|-8.8|
73869785|NCT01620528|147283309|SUPERIORITY||Difference in LS Means|-2.65|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-3.98|-1.32|||ANCOVA|||||-1.32|-3.98|< 0.001
73945626|NCT01597505|147423719|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|0.6|||||TWO_SIDED|95.0|-7.2|8.3|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||8.3|-7.2|
73945627|NCT01597505|147423720|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-3.5|||||TWO_SIDED|95.0|-10.0|3.0|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||3.0|-10.0|
73945628|NCT01597505|147423721|SUPERIORITY|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.431||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value||||0.431
73945629|NCT01597505|147423722|SUPERIORITY|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.011||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value||||0.011
73945630|NCT01597505|147423723|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|2.2|||||TWO_SIDED|95.0|-10.7|14.8|||||Treatment group percentages were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants||14.8|-10.7|
73945631|NCT01597505|147423724|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-2.4|||||TWO_SIDED|95.0|-7.8|3.0|||||Treatment group proportions were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants||3.0|-7.8|
73945632|NCT01597505|147423725|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|14.6|||||TWO_SIDED|95.0|-2.7|30.7|||||Treatment group percentages were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants||30.7|-2.7|
73945633|NCT01597505|147423726|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|4.3|||||TWO_SIDED|95.0|-4.2|12.7|||||Treatment group proportions were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants||12.7|-4.2|
73945634|NCT05454410|147423727|SUPERIORITY||Mean Difference (Net)|-5.2|||||TWO_SIDED|90.0|-9.6|-0.7|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||-0.7|-9.6|
73945635|NCT05454410|147423727|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|90.0|-7.0|2.1|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||2.1|-7.0|
73945636|NCT05454410|147423727|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|90.0|-4.0|5.1|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||5.1|-4.0|
73945637|NCT05454410|147423733|SUPERIORITY|||||||0.0242||||||P-value for the selected model best representing the underlying DR (the lowest p-value out of the 6 candidate models), adjusted for multiple comparisons.|Multiple contrast test|||MCP-Mod was used to check if there was a DR relationship between the change from baseline to 24 hours in MADRS total score and the doses received. The Least squares means under the primary estimand were used to test the null hypothesis of a flat DR relationship at a one-sided significance level of 5% against the alternative hypothesis of a non-flat DR curve. Six candidate DR curves were used to derive the optimal model contrasts for the multiple contrast tests. A monotone DR was assumed.||||0.0242
74009012|NCT01641237|147568704|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.65||||0.0038|TWO_SIDED|95.0|3.48|17.81||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||17.81|3.48|0.0038
73869786|NCT01620528|147283310|SUPERIORITY||Difference in LS Means|-2.17|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-3.39|-0.95|||ANCOVA|||||-0.95|-3.39|< 0.001
73869787|NCT01620528|147283310|SUPERIORITY||Difference in LS Means|-3.0|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.23|-1.76|||ANCOVA|||||-1.76|-4.23|< 0.001
74089250|NCT02697773|147731607|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.33|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.50|-1.33|<.0001
73869788|NCT01620528|147283311|SUPERIORITY||Difference in LS Means|-1.54|STANDARD_ERROR_OF_MEAN|0.64||0.017|TWO_SIDED|95.0|-2.8|-0.27|||ANCOVA|||||-0.27|-2.80|0.017
73869789|NCT01620528|147283311|SUPERIORITY||Difference in LS Means|-3.24|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-4.5|-1.98|||ANCOVA|||||-1.98|-4.50|< 0.001
73869790|NCT01620528|147283312|SUPERIORITY||Difference in LS Means|-1.14|STANDARD_ERROR_OF_MEAN|0.55||0.038|TWO_SIDED|95.0|-2.22|-0.07|||ANCOVA|||||-0.07|-2.22|0.038
73869791|NCT01620528|147283312|SUPERIORITY||Difference in LS Means|-2.83|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.91|-1.74|||ANCOVA|||||-1.74|-3.91|< 0.001
73869792|NCT01620528|147283313|SUPERIORITY||Difference in LS Means|-1.83|STANDARD_ERROR_OF_MEAN|0.66||0.006|TWO_SIDED|95.0|-3.13|-0.54|||ANCOVA|||||-0.54|-3.13|0.006
73869793|NCT01620528|147283313|SUPERIORITY||Difference in LS Means|-3.75|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-5.06|-2.44|||ANCOVA|||||-2.44|-5.06|< 0.001
73869794|NCT04146935|147283332|OTHER|Mixed model repeated measures||||||0.4147||||||Visit 1 (baseline) to visit 4 (peak)|Mixed Models Analysis|||||||0.4147
73869795|NCT04146935|147283333|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
73869796|NCT04146935|147283334|OTHER|Mixed model repeated measures||||||0.6957|||||||Mixed Models Analysis|||||||0.6957
73869797|NCT04146935|147283335|OTHER|||||||0.0092|||||||Mixed Models Analysis|||||||0.0092
73869798|NCT04146935|147283336|OTHER|Mixed model repeated measures||||||0.1383|||||||Mixed Models Analysis|||||||0.1383
73869799|NCT04146935|147283337|OTHER|mixed model repeated measures||||||0.0572|||||||Mixed Models Analysis|||||||0.0572
73945638|NCT00895622|147423783|OTHER||Kappa statistic|0.79|||<|0.0001|TWO_SIDED|95.0|0.71|0.87|||Z test|||"The Kappa (κ) coefficient was used to assess the measure of agreement between the reviewers. κ can be interpreted as follows (κ / Agreement):~\< 0 / Less than chance agreement; 0.01-0.20 / Slight agreement; 0.21-0.40 / Fair agreement; 0.41-0.60 / Moderate agreement; 0.61-0.80 / Substantial agreement; 0.81-0.99 / Almost perfect agreement.~The asymptotic test of the null hypothesis: κ=0 will be performed using the Z-statistic to determine the strength of agreement."||0.87|0.71|<0.0001
73945639|NCT00947661|147423786|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of covariance included treatment, site, and intraocular pressure group as a covariate. Two-sided 95% confidence interval for the difference between treatment groups in estimated mean change from baseline lease square means was computed for each time point. Non-inferiority of SPARC drug relative to Reference was established if: 95% confidence interval included 0, the upper limit of the 95% CI was \<1.5, and upper limit of 95% CI was \<1 at most (at least 7 of 12) time point.|||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
73945640|NCT02552238|147423792|SUPERIORITY|||||||0.0067|||||||McNemar|||Sensitivity: superiority test comparing CE-DSE and UE-DSE based on the difference||||0.0067
73945641|NCT02552238|147423792|SUPERIORITY||||||<|0.0001|||||||McNemar|||Specificity: superiority test comparing CE-DSE and UE-DSE based on the difference||||<0.0001
73869800|NCT04038567|147283338|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-1.14|1.2||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.20|-1.14|
73869801|NCT04038567|147283338|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|95.0|-2.39|-0.04||||||Values are change in model-estimated means for his vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.04|-2.39|
73869802|NCT04038567|147283338|SUPERIORITY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-1.12|1.23||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.23|-1.12|
73869803|NCT04038567|147283339|SUPERIORITY||Mean Difference (Net)|-1.14|||||TWO_SIDED|95.0|-2.12|-0.16||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.16|-2.12|
73869804|NCT04038567|147283339|SUPERIORITY||Mean Difference (Final Values)|-0.82|||||TWO_SIDED|95.0|-1.8|1.49||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.49|-1.80|
73945642|NCT02036645|147423809|SUPERIORITY_OR_OTHER||Slope|0.93|||||TWO_SIDED|95.0|0.82|1.04|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.04|0.82|
73869805|NCT04038567|147283339|SUPERIORITY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.48|1.49||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.49|-0.48|
73945643|NCT02036645|147423809|SUPERIORITY_OR_OTHER||Slope|1.01|||||TWO_SIDED|95.0|0.71|1.3|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.30|0.71|
73945644|NCT02036645|147423810|SUPERIORITY_OR_OTHER||Slope|0.9|||||TWO_SIDED|95.0|0.81|0.98|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||0.98|0.81|
73945645|NCT02036645|147423810|SUPERIORITY_OR_OTHER||Slope|0.96|||||TWO_SIDED|95.0|0.65|1.27|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.27|0.65|
73945646|NCT01986101|147423816|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.0||0.007|TWO_SIDED|95.0|-4.9|-1.0||Hochberg-adjusted|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-1.0|-4.9|0.007
74089251|NCT02697773|147731607|SUPERIORITY||Least Square Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.45|-0.6|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.60|-1.45|<.0001
73869806|NCT04038567|147283340|SUPERIORITY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-1.66|1.01||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.01|-1.66|
73975996|NCT05890794|147497009|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-22.51|STANDARD_ERROR_OF_MEAN|6.289||0.0024|TWO_SIDED|95.0|-35.81|-9.2||Significant test: two-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for PLP.||-9.20|-35.81|0.0024
73975997|NCT05890794|147497010|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|-4335.66||||0.0019|TWO_SIDED|95.0|-6652.753|-2018.576||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for ALP activity.||-2018.576|-6652.753|0.0019
73975998|NCT05890794|147497011|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|23.25||||0.0693|TWO_SIDED|95.0|-2.319|48.812||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for urine PEA.||48.812|-2.319|0.0693
73975999|NCT05890794|147497011|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-8.76|STANDARD_ERROR_OF_MEAN|22.986||0.7086|TWO_SIDED|95.0|-57.88|40.35||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for urine PEA.||40.35|-57.88|0.7086
73976000|NCT05890794|147497012|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|187.43||||0.0199|TWO_SIDED|95.0|36.516|338.344||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PL.||338.344|36.516|0.0199
73976001|NCT05890794|147497012|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-12.51|STANDARD_ERROR_OF_MEAN|9.767||0.2034|TWO_SIDED|95.0|-31.92|6.89||Significant test: 2-sided; significance level 5%|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for PL.||6.89|-31.92|0.2034
73976002|NCT05890794|147497013|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|-0.89||||0.5195|TWO_SIDED|95.0|-3.868|2.084||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in fold change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PL/PLP ratio.||2.084|-3.868|0.5195
73976003|NCT05890794|147497013|OTHER|The difference between LS Means of fold change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|1.01|STANDARD_ERROR_OF_MEAN|0.161|<|0.0001|TWO_SIDED|95.0|0.69|1.33||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in fold change form baseline (LS Means) between dose levels of ilofotase alfa by an MMRM analysis for PL/PLP ratio.||1.33|0.69|<0.0001
73976004|NCT03516942|147497015|EQUIVALENCE|No margin of equivalence|Slope|0.0||||0.74|TWO_SIDED|95.0|-0.1|0.2||P value: For the categorical variable with more than 2 levels, this is the p value from the overall test of the null hypothesis that all estimates are equal against the alternative that at least one is different.|Regression, Linear|||"Age covariate effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||0.2|-0.1|0.74
74009013|NCT01641237|147568705|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for EFU as a function of fluoride concentration.||||<0.0001
74009014|NCT01641237|147568705|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for EFU as a function of fluoride concentration.||||0.0008
73945647|NCT01986101|147423816|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|1.03||0.057|TWO_SIDED|95.0|-4.0|0.1||Hochberg-adjusted.|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.1|-4.0|0.057
73945648|NCT01986101|147423817|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.127||0.002|TWO_SIDED|95.0|-0.65|-0.15|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.15|-0.65|0.002
73945649|NCT01986101|147423817|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13||0.019|TWO_SIDED|95.0|-0.56|-0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in SM-13496 group over the placebo group.|||-0.05|-0.56|0.019
73945650|NCT01986101|147423818|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.89||0.037|TWO_SIDED|95.0|-3.6|-0.1|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.1|-3.6|0.037
73945651|NCT01986101|147423818|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.92||0.223|TWO_SIDED|95.0|-2.9|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.7|-2.9|0.223
73945652|NCT01986101|147423819|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.262||0.076|TWO_SIDED|95.0|-0.98|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.05|-0.98|0.076
73945653|NCT01986101|147423819|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.269||0.075|TWO_SIDED|95.0|-1.01|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.05|-1.01|0.075
73945654|NCT01986101|147423820|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.016|TWO_SIDED|95.0|-3.1|-0.3|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.3|-3.1|0.016
73945655|NCT01986101|147423820|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.71||0.294|TWO_SIDED|95.0|-2.1|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.7|-2.1|0.294
73976005|NCT03516942|147497015|EQUIVALENCE|No margin of equivalence|Slope|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3||P value: For the categorical variable with more than 2 levels, this is the p value from the overall test of the null hypothesis that all estimates are equal against the alternative that at least one is different.|Regression, Linear|||"Baseline COST effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||-0.3|-0.6|<0.001
73976006|NCT03516942|147497015|EQUIVALENCE|No margin of equivalence||||||0.002||||||This is the p value of the null hypothesis that COST estimates for all cancer types (Colon cancer, Rectal cancer and Rectosigmoid) are equal against the alternative that at least one is different.|Regression, Linear|||"Cancer type (Colon cancer, Rectal cancer and Rectosigmoid) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||||0.002
73945656|NCT02404389|147423822|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.07||0.515|TWO_SIDED|90.0|-0.12|0.12|||Posterior mean|||||0.12|-0.12|0.515
73945657|NCT02404389|147423822|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.07||0.517|TWO_SIDED|90.0|-0.12|0.13|||posterior mean|||||0.13|-0.12|0.517
73945658|NCT00335257|147423828|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test of two exponential survival curves.These calculations are based on the following assumptions: 1) one-sided α 0.025; 2) power (1-β) of 0.90; 3) VTE incidence rate of 9/10.000 WY and 4) non-inferiority limit hazard ratio of 2. Furthermore, a study of this size would exclude a threefold risk of ATE.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE|Tested null hypotheses: the VTE hazard ratio for DRSP(24d) vs. Non-DRSP is higher or equal to 2||1.3|0.5|
73945659|NCT03324880|147423830|SUPERIORITY||Difference in Least Squares (LS) Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.189|=|0.003|TWO_SIDED|95.0|-0.9|-0.15||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom subscale score.|-0.15|-0.90|=0.003
73945660|NCT03324880|147423831|SUPERIORITY||Difference in LS Mean|10.5|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|5.1|15.9||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACIT-Fatigue total score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACIT-Fatigue total score.|15.9|5.1|<0.001
73945661|NCT03324880|147423832|SUPERIORITY||Difference in LS Mean|4.242|STANDARD_ERROR_OF_MEAN|1.9219|=|0.015|TWO_SIDED|95.0|0.413|8.072||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 PCS score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 PCS score.|8.072|0.413|=0.015
73945662|NCT03324880|147423833|SUPERIORITY||Difference in LS Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.112|=|0.002|TWO_SIDED|95.0|-0.55|-0.1||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact subscale score.|-0.10|-0.55|=0.002
73945663|NCT03324880|147423834|SUPERIORITY||Difference in LS Mean|-0.28|STANDARD_ERROR_OF_MEAN|0.125|=|0.013|TWO_SIDED|95.0|-0.53|-0.04||1-sided p-value was reported.|MMRM|||Impact on Sleep|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.04|-0.53|=0.013
73945664|NCT03324880|147423834|SUPERIORITY||Difference in LS Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.128|=|0.003|TWO_SIDED|95.0|-0.61|-0.11||1-sided p-value was reported.|MMRM|||Ability to Exercise|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.11|-0.61|=0.003
73945665|NCT03324880|147423834|SUPERIORITY||Difference in LS Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.123|=|0.002|TWO_SIDED|95.0|-0.61|-0.12||1-sided p-value was reported.|MMRM|||Ability to Complete Work|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.12|-0.61|=0.002
73945666|NCT03324880|147423834|SUPERIORITY||Difference in LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.121|=|0.002|TWO_SIDED|95.0|-0.61|-0.13||1-sided p-value was reported.|MMRM|||Impact Family Relationships|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.13|-0.61|=0.002
73945667|NCT03324880|147423835|SUPERIORITY||Difference in LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.203|=|0.004|TWO_SIDED|95.0|-0.96|-0.15||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD anxiety item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD anxiety item score.|-0.15|-0.96|=0.004
73945668|NCT03324880|147423836|SUPERIORITY||Difference in LS Mean|-0.54|STANDARD_ERROR_OF_MEAN|0.2|=|0.004|TWO_SIDED|95.0|-0.93|-0.14||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD sadness or depression item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD sadness or depression item score.|-0.14|-0.93|=0.004
73945669|NCT03324880|147423837|SUPERIORITY||Difference in LS Mean|-0.56|STANDARD_ERROR_OF_MEAN|0.218|=|0.006|TWO_SIDED|95.0|-0.99|-0.12||1-sided p-value was reported.|MMRM|||Muscle Cramps|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.12|-0.99|=0.006
73945670|NCT03324880|147423837|SUPERIORITY||Difference in LS Mean|-0.54|STANDARD_ERROR_OF_MEAN|0.213|=|0.007|TWO_SIDED|95.0|-0.96|-0.12||1-sided p-value was reported.|MMRM|||Tingling|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.12|-0.96|=0.007
73869807|NCT04038567|147283340|SUPERIORITY||Mean Difference (Final Values)|-1.47|||||TWO_SIDED|95.0|-2.81|-0.14||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.14|-2.81|
73945671|NCT03324880|147423837|SUPERIORITY||Difference in LS Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.231|=|0.02|TWO_SIDED|95.0|-0.94|-0.02||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.02|-0.94|=0.020
73945672|NCT03324880|147423837|SUPERIORITY||Difference in LS Mean|-0.62|STANDARD_ERROR_OF_MEAN|0.219|=|0.003|TWO_SIDED|95.0|-1.05|-0.18||1-sided p-value was reported.|MMRM|||Muscle Spasms|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.18|-1.05|=0.003
73945673|NCT03324880|147423837|SUPERIORITY||Difference in LS Mean|-0.38|STANDARD_ERROR_OF_MEAN|0.229|=|0.05|TWO_SIDED|95.0|-0.83|0.07||1-sided p-value was reported.|MMRM|||Feelings of Heaviness|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|0.07|-0.83|=0.050
73945674|NCT03324880|147423837|SUPERIORITY||Difference in LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.227|=|0.008|TWO_SIDED|95.0|-1.01|-0.1||1-sided p-value was reported.|MMRM|||Physical Fatigue|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.10|-1.01|=0.008
73945675|NCT03324880|147423837|SUPERIORITY||Difference in LS Mean|-0.51|STANDARD_ERROR_OF_MEAN|0.186|=|0.004|TWO_SIDED|95.0|-0.87|-0.14||1-sided p-value was reported.|MMRM|||Brain Fog|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.14|-0.87|=0.004
73945676|NCT03324880|147423839|SUPERIORITY||Difference in LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|0.235|<|0.001|TWO_SIDED|95.0|-1.37|-0.43||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD most bothersome symptom score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD most bothersome symptom score.|-0.43|-1.37|<0.001
73945677|NCT03324880|147423840|SUPERIORITY||Difference in LS Mean|2.1|STANDARD_ERROR_OF_MEAN|1.07|=|0.024|TWO_SIDED|95.0|0.0|4.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACT-Cog Perceived Cognitive Impairments Subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACT-Cog Perceived Cognitive Impairments Subscale score.|4.3|0.0|=0.024
73945678|NCT03324880|147423841|SUPERIORITY||Difference in LS Mean|2.1|STANDARD_ERROR_OF_MEAN|1.07|=|0.024|TWO_SIDED|95.0|0.0|4.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACT-Cog QoL Subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACT-Cog QoL Subscale score.|4.3|0.0|=0.024
73945679|NCT03324880|147423842|SUPERIORITY||Difference in LS Mean|7.21|STANDARD_ERROR_OF_MEAN|2.1376|=|0.001|TWO_SIDED|95.0|2.951|11.469||1-sided p-value was reported.|MMRM|||Standard-Bodily Pain|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|11.469|2.951|=0.001
73945680|NCT03324880|147423842|SUPERIORITY||Difference in LS Mean|5.545|STANDARD_ERROR_OF_MEAN|2.0542|=|0.004|TWO_SIDED|95.0|1.452|9.638||1-sided p-value was reported.|MMRM|||Standard-General Health|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|9.638|1.452|=0.004
73945681|NCT03324880|147423842|SUPERIORITY||Difference in LS Mean|7.857|STANDARD_ERROR_OF_MEAN|2.2913|<|0.001|TWO_SIDED|95.0|3.292|12.423||1-sided p-value was reported.|MMRM|||Standard-Mental Health|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|12.423|3.292|<0.001
73945682|NCT03324880|147423842|SUPERIORITY||MMRM|4.554|STANDARD_ERROR_OF_MEAN|2.1123|=|0.017|TWO_SIDED|95.0|0.345|8.763||1-sided p-value was reported.|MMRM|||Standard-Physical Functioning|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|8.763|0.345|=0.017
73976007|NCT03516942|147497015|EQUIVALENCE|No margin of equivalence|Slope|0.3||||0.03|TWO_SIDED|95.0|0.0|0.6|||Regression, Linear|||"FACT-G7 effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||0.6|0.0|0.03
73976008|NCT03516942|147497015|EQUIVALENCE|No margin of equivalence|Slope|1.6||||0.13|TWO_SIDED|95.0|-0.5|3.7|||Regression, Linear|||"Gender effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||3.7|-0.5|0.13
73976009|NCT03516942|147497015|EQUIVALENCE|No margin of equivalence||||||0.91||||||This is the p value of the null hypothesis that COST estimates for all RACES (White, Black, other) are equal against the alternative that at least one is different.|Regression, Linear|||"RACE (White. Black Other) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||||0.91
74031753|NCT00431847|147616787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05816|STANDARD_ERROR_OF_MEAN|0.221||0.7926|TWO_SIDED|95.0|-0.4929|0.3766|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3766|-0.4929|0.7926
74031754|NCT00431847|147616787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1708|STANDARD_ERROR_OF_MEAN|0.3212||0.5953|TWO_SIDED|95.0|-0.461|0.8026|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.8026|-0.4610|0.5953
73976010|NCT03516942|147497015|EQUIVALENCE|No margin of equivalence|Slope|0.0|||>|0.99|TWO_SIDED|95.0|-0.3|0.3|||Regression, Linear|||"Neighborhood Deprivation (NDI) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Higher NDI = greater neighborhood deprivation"||0.3|-0.3|>0.99
73976011|NCT03516942|147497017|EQUIVALENCE|no margin||||||0.4142||||||alpha=0.05|McNemar|||Work Time Missed from Baseline to 6 Months||||0.4142
73976012|NCT03516942|147497017|EQUIVALENCE|no margin||||||0.1797|||||||McNemar|||Impairment of Activities at Work from Baseline to 6 Months||||0.1797
73976013|NCT03516942|147497017|EQUIVALENCE|no margin||||||0.8415|||||||McNemar|||Overall Work Impairment from Baseline to 6 Months||||0.8415
73976014|NCT03516942|147497017|EQUIVALENCE|no margin||||||0.6831|||||||McNemar|||Impairment of Activities Outside of Work from Baseline to 6 Months||||0.6831
73945683|NCT03324880|147423842|SUPERIORITY||Difference in LS Mean|8.42|STANDARD_ERROR_OF_MEAN|2.3186|<|0.001|TWO_SIDED|95.0|3.8|13.04||1-sided p-value was reported.|MMRM|||Standard-Role-Emotional|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|13.040|3.800|<0.001
73945684|NCT03324880|147423842|SUPERIORITY||Difference in LS Mean|4.23|STANDARD_ERROR_OF_MEAN|2.2489|=|0.032|TWO_SIDED|95.0|-0.251|8.711||1-sided p-value was reported.|MMRM|||Standard-Role-Physical|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|8.711|-0.251|=0.032
73945685|NCT03324880|147423842|SUPERIORITY||Difference in LS Mean|3.809|STANDARD_ERROR_OF_MEAN|2.6658|=|0.079|TWO_SIDED|95.0|-1.502|9.121||1-sided p-value was reported.|MMRM|||Standard-Social Functioning|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|9.121|-1.502|=0.079
73945686|NCT03324880|147423842|SUPERIORITY||Difference in LS Mean|7.942|STANDARD_ERROR_OF_MEAN|2.353|=|0.001|TWO_SIDED|95.0|3.253|12.63||1-sided p-value was reported.|MMRM|||Standard-Vitality|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|12.630|3.253|=0.001
73945687|NCT03324880|147423843|SUPERIORITY||Difference in LS Mean|8.3|STANDARD_ERROR_OF_MEAN|2.2642|<|0.001|TWO_SIDED|95.0|3.788|12.811||1-sided p-value|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 MCS score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 MCS score.|12.811|3.788|<0.001
73976015|NCT03516942|147497017|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Work Time Missed from Baseline to 12 Months||||<.0001
73976016|NCT03516942|147497017|EQUIVALENCE|no margin||||||0.0455|||||||McNemar|||Impairment of Activities at Work from Baseline to 12 Months||||0.0455
73976017|NCT03516942|147497017|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Overall Work Impairment from Baseline to 12 Months||||<.0001
73976018|NCT03516942|147497017|EQUIVALENCE|no margin||||||0.0164|||||||McNemar|||3 Impairment of Activities Outside of Work from Baseline to 12 Months||||0.0164
73976019|NCT03516942|147497017|EQUIVALENCE|nomargin||||||0.0027|||||||McNemar|||Work Time Missed from Baseline to 24 Months||||0.0027
73869808|NCT04038567|147283340|SUPERIORITY||Mean Difference (Final Values)|0.82|||||TWO_SIDED|95.0|-0.52|2.15||||||Values are change in model-estimated means for therapist vs. app response to symptoms. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.15|-0.52|
73945688|NCT03324880|147423844|SUPERIORITY||Difference in LS Mean|3.13|STANDARD_ERROR_OF_MEAN|9.578|=|0.627|TWO_SIDED|95.0|-16.33|22.6||1-sided p-value was reported.|MMRM|||Percent Work Time Missed Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|22.60|-16.33|=0.627
73945689|NCT03324880|147423844|SUPERIORITY||Difference in LS Mean|-14.6|STANDARD_ERROR_OF_MEAN|7.52|=|0.031|TWO_SIDED|95.0|-29.9|0.7||1-sided p-value was reported.|MMRM|||Percent Impairment While Working Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|0.7|-29.9|=0.031
73945690|NCT03324880|147423844|SUPERIORITY||Difference in LS Mean|-14.9|STANDARD_ERROR_OF_MEAN|6.146|=|0.011|TWO_SIDED|95.0|-27.42|-2.39||1-sided p-value was reported.|MMRM|||Percent Overall Work Impairment Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|-2.39|-27.42|=0.011
73976020|NCT03516942|147497017|EQUIVALENCE|no margin||||||0.0124|||||||McNemar|||Impairment of Activities at Work from Baseline to 24 Months||||0.0124
73976021|NCT03516942|147497017|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Overall Work Impairment from Baseline to 24 Months||||<.0001
73976022|NCT03516942|147497017|EQUIVALENCE|no margin||||||0.0011|||||||McNemar|||Impairment of Activities Outside of Work from Baseline to 24 Months||||0.0011
73869809|NCT04038567|147283341|SUPERIORITY||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-1.23|0.91||||||||0.91|-1.23|
73976023|NCT03516942|147497023|EQUIVALENCE|no equivalence margin was assumed||||||0.017|||||||McNemar|||the McNemar test was used to compare the results assuming a null of no difference.||||0.017
73976024|NCT05613907|147497047|SUPERIORITY||Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|5.885||0.005|TWO_SIDED|95.0|-37.05|-6.15|||ANOVA|||||-6.150|-37.050|0.005
73976025|NCT05613907|147497047|SUPERIORITY||Mean Difference (Net)|-17.8|STANDARD_ERROR_OF_MEAN|6.512||0.04|TWO_SIDED|95.0|-34.895|-0.705|||ANOVA|||||-0.705|-34.895|0.040
73976026|NCT05613907|147497047|SUPERIORITY||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|3.668||0.94|TWO_SIDED|95.0|-5.829|13.429|||ANOVA|||||13.429|-5.829|0.940
73976027|NCT05613907|147497048|SUPERIORITY||Z statistic|-0.862||||0.388|TWO_SIDED||||||Wilcoxon Signed Ranks|||The null hypothesis is that there will be no significant difference in the EuroQol 5-D domains at 1 year compared to baseline.||||0.388
73976028|NCT05613907|147497049|SUPERIORITY||Z statistic|-0.033||||0.974|TWO_SIDED||||||Wilcoxon signed rank|||The null hypothesis is that there will be no statistical difference in patient self-reported ability to perform basic self-care||||0.974
73976029|NCT05613907|147497050|SUPERIORITY||Z statistic|-1.564||||0.118|TWO_SIDED||||||Wilcoxon signed rank|||The null hypothesis is no improvement in ability to perform usual activities at 1 year.||||0.118
73976030|NCT05613907|147497051|SUPERIORITY||Z statistic|-2.364||||0.018|TWO_SIDED||||||Wilcoxon signed rank|||||||0.018
73976031|NCT05613907|147497052|SUPERIORITY||Z statistic|-1.311||||0.19|TWO_SIDED|||||The null hypothesis is that there will be no difference in anxiety and/or depression compared to the initial visit.|Wilcoxon signed rank|||||||0.190
73945691|NCT03324880|147423844|SUPERIORITY||Difference in LS Mean|-13.0|STANDARD_ERROR_OF_MEAN|5.78|=|0.014|TWO_SIDED|95.0|-24.5|-1.5||1-sided p-value was reported.|MMRM|||Percent Activity Impairment Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|-1.5|-24.5|=0.014
73945692|NCT03324880|147423845|SUPERIORITY||Difference in LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.22|=|0.01|TWO_SIDED|95.0|-1.0|-0.1||1-sided p-value|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in PGI-S score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline PGI-S score.|-0.1|-1.0|=0.010
73945693|NCT03324880|147423847|SUPERIORITY||Difference in LS Mean|0.01|||=|0.516|TWO_SIDED|95.0|-0.03|0.05|||ANCOVA|From an Analysis of Covariance (ANCOVA) with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Detection||0.05|-0.03|=0.516
73945694|NCT03324880|147423847|SUPERIORITY||Difference in LS Mean|0.02|||=|0.275|TWO_SIDED|95.0|-0.02|0.06|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Identification||0.06|-0.02|=0.275
73945695|NCT03324880|147423847|SUPERIORITY||Difference in LS Mean|0.01|||=|0.777|TWO_SIDED|95.0|-0.05|0.07|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||One Card Learning||0.07|-0.05|=0.777
73976032|NCT05613907|147497053|SUPERIORITY||Mean Difference (Net)|-26.846|STANDARD_ERROR_OF_MEAN|8.604||0.027|TWO_SIDED|95.0|-50.762|-2.39|||ANOVA|||||-2.390|-50.762|0.027
73976033|NCT05613907|147497053|SUPERIORITY||Mean Difference (Net)|-27.615|STANDARD_ERROR_OF_MEAN|8.715||0.024|TWO_SIDED|95.0|-51.837|-3.394|||ANOVA|||||-3.394|-51.837|0.024
73976034|NCT05613907|147497053|SUPERIORITY||Mean Difference (Net)|-0.769|STANDARD_ERROR_OF_MEAN|4.535||1|TWO_SIDED|95.0|-13.374|11.836|||ANOVA|||||11.836|-13.374|1.000
73976035|NCT05613907|147497054|SUPERIORITY||Mean Difference (Net)|-14.27|STANDARD_ERROR_OF_MEAN|4.052||0.048|TWO_SIDED|95.0|-37.05|-6.15|||ANOVA|||||-6.150|-37.050|0.048
73976036|NCT05613907|147497054|SUPERIORITY||Median Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|3.751||1|TWO_SIDED|95.0|-12.893|13.751|||ANOVA|||||13.751|-12.893|1.000
73976037|NCT05613907|147497054|SUPERIORITY||Mean Difference (Net)|12.26|STANDARD_ERROR_OF_MEAN|5.186||0.163|TWO_SIDED|95.0|-4.762|29.333|||ANOVA|||||29.333|-4.762|0.163
73976038|NCT04218357|147497064|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||GEE|Generalized Estimating Equation with standard errors, and an unstructured correlation matrix with medication and time as within-subject factors.||All outcomes were assessed in real-time in the laboratory testing probenecid compared to placebo condition during the alcohol administration procedure.||||0.05
73976039|NCT01958021|147497080|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.556||||3.29e-06|TWO_SIDED|95.0|0.429|0.72|||Log Rank|||||0.720|0.429|0.00000329
73945696|NCT03324880|147423847|SUPERIORITY||Difference in LS Mean|0.01|||=|0.831|TWO_SIDED|95.0|-0.04|0.05|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||One Back (ONB)||0.05|-0.04|=0.831
73976040|NCT01958021|147497081|SUPERIORITY||Hazard Ratio (HR)|0.765||||0.004|TWO_SIDED|95.0|0.628|0.932|||Log Rank|||||0.932|0.628|0.004
73976041|NCT01958021|147497082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.000155|||||||Cochran-Mantel-Haenszel|||||||0.000155
73976042|NCT01958021|147497083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Cochran-Mantel-Haenszel|||||||0.018
73945697|NCT03324880|147423847|SUPERIORITY||Difference in LS Mean|9.93|||=|0.075|TWO_SIDED|95.0|-1.0|20.85|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Groton Maze Learning (GML)||20.85|-1.00|=0.075
73945698|NCT03324880|147423847|SUPERIORITY||Difference in LS Mean|-0.57|||=|0.545|TWO_SIDED|95.0|-2.41|1.27|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||International Shopping List (ISL)||1.27|-2.41|=0.545
73945699|NCT03324880|147423847|SUPERIORITY||Difference in LS Mean|0.55|||=|0.283|TWO_SIDED|95.0|-0.45|1.56|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||International Shopping List Test Delayed Recall (ISRL)||1.56|-0.45|=0.283
73976043|NCT04701203|147497099|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||For the primary efficacy endpoint, the Cochran-Mantel Haenszel test stratified by etiology of hypoparathyroidism (postsurgical or other) was used to compare the proportion of participants meeting the composite primary endpoint in the TransCon PTH versus placebo groups. Participants without week 26 albumin-adjusted serum calcium or with \>25% (ie, \>7 days) missing diary data of active vitamin D or elemental calcium during the 4 weeks before week 26 were considered non-responders.||||<0.0001
73945700|NCT03324880|147423848|SUPERIORITY||Difference in LS Mean|0.01|||=|0.582|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||Detection (DET)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.582
73976044|NCT04701203|147497100|SUPERIORITY||||||=|0.0038|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0038
73976045|NCT04701203|147497101|SUPERIORITY||||||=|0.0055|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0055
73976046|NCT04701203|147497102|SUPERIORITY||||||=|0.0046|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0046
73945701|NCT03324880|147423848|SUPERIORITY||Difference in LS Mean|0.01|||=|0.492|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||Identification (IDN)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.492
73945702|NCT03324880|147423848|SUPERIORITY||Difference in LS Mean|0.01|||=|0.506|TWO_SIDED|95.0|-0.03|0.06||1-sided p-value was reported.|MMRM|||One Card Learning (OCL)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.06|-0.03|=0.506
73945703|NCT03324880|147423848|SUPERIORITY||Difference in LS Mean|0.01|||=|0.438|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||One Back Test|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.438
73945704|NCT03324880|147423849|SUPERIORITY||Difference in LS Mean|2.09|STANDARD_ERROR_OF_MEAN|0.871|=|0.991|TWO_SIDED|95.0|0.36|3.83||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in 24-hour urine calcium excretion as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline 24-Hour urine calcium excretion.|3.83|0.36|=0.991
73945705|NCT03324880|147423850|SUPERIORITY||Difference in LS Mean|-0.175|STANDARD_ERROR_OF_MEAN|0.0395|<|0.001|TWO_SIDED|95.0|-0.254|-0.097||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in serum phosphate as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline serum phosphate.|-0.097|-0.254|<0.001
73945706|NCT03324880|147423851|SUPERIORITY||Difference in LS Mean|4.08|STANDARD_ERROR_OF_MEAN|4.654|=|0.81|TWO_SIDED|95.0|-5.06|13.22||1-sided p-value was reported.|MMRM||||From a mixed-effects model for repeated measures (MMRM) analysis over all post-baseline visits, with the change from baseline in active vitamin D supplement dose as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline active vitamin D supplement dose.|13.22|-5.06|=0.810
73945707|NCT03324880|147423852|SUPERIORITY||Difference in LS Mean|-331.3|STANDARD_ERROR_OF_MEAN|132.56|=|0.007|TWO_SIDED|95.0|-594.6|-67.9||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in elemental calcium supplement dose as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline elemental calcium supplement dose.|-67.9|-594.6|=0.007
73945708|NCT03324880|147423855|SUPERIORITY||Difference in LS Mean|22.33|STANDARD_ERROR_OF_MEAN|3.271|<|0.001|TWO_SIDED|95.0|15.83|28.84||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|28.84|15.83|<0.001
73945709|NCT03324880|147423856|SUPERIORITY||Difference in LS Mean|785.5|STANDARD_ERROR_OF_MEAN|113.65|<|0.001|TWO_SIDED|95.0|559.6|1011.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|1011.3|559.6|<0.001
73945710|NCT03324880|147423857|SUPERIORITY||Difference in LS Mean|56.43|STANDARD_ERROR_OF_MEAN|6.091|<|0.001|TWO_SIDED|95.0|44.33|68.53||1-sided p-value was reported.|MMRM|||Osteocalcin|MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|68.53|44.33|<0.001
73945711|NCT03324880|147423857|SUPERIORITY||Difference in LS Mean|226.57|STANDARD_ERROR_OF_MEAN|33.425|<|0.001|TWO_SIDED|95.0|160.17|292.98||1-sided p-value was reported.|MMRM|||Procollagen 1 N-Terminal Propeptide|MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|292.98|160.17|<0.001
73945712|NCT01412801|147423886|SUPERIORITY_OR_OTHER||Vaccine Group Ratios (Serotype Ia)|0.96|||||TWO_SIDED|98.4|0.71|1.3||||||||1.3|0.71|
73945713|NCT01412801|147423886|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ia)|0.81|||||TWO_SIDED|98.4|0.6|1.09||||||||1.09|0.6|
73945714|NCT01412801|147423886|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ia)|0.84|||||TWO_SIDED|98.4|0.63|1.14||||||||1.14|0.63|
73945715|NCT01412801|147423886|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|0.8|||||TWO_SIDED|98.4|0.49|1.29||||||||1.29|0.49|
73945716|NCT01412801|147423886|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|1.05|||||TWO_SIDED|98.4|0.65|1.69||||||||1.69|0.65|
73945717|NCT01412801|147423886|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|1.32|||||TWO_SIDED|98.4|0.85|2.06||||||||2.06|0.85|
73945718|NCT01412801|147423886|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|1.17|||||TWO_SIDED|98.4|0.66|2.07||||||||2.07|0.66|
73945719|NCT01412801|147423886|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|1.06|||||TWO_SIDED|98.4|0.63|1.78||||||||1.78|0.63|
73945720|NCT01412801|147423886|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|0.91|||||TWO_SIDED|98.4|0.52|1.58||||||||1.58|0.52|
73945721|NCT00116272|147423887|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.77|||||TWO_SIDED|95.0|1.04|7.35|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height|||7.35|1.04|
73945722|NCT00116272|147423888|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37|||||TWO_SIDED|95.0|1.02|5.52|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height|||5.52|1.02|
73945723|NCT00116272|147423889|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.7|2.01|||||Unadjusted Odds Ratio computed using logistic regression. No adjusted estimate was computed due to no confirmed confounder.|||2.01|0.70|
73945724|NCT00116272|147423891|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.2|1.12|||||Adjusted HR computed using Cox proportional hazards regression adjusted for propensity score comprised of referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other), and maternal height.|||1.12|0.20|
73945725|NCT00116272|147423892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|0.86|2.98|||||Adjusted HR computed using Cox proportional hazards regression adjusted for preeclampsia|||2.98|0.86|
73945726|NCT00116272|147423893|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-0.2|||||TWO_SIDED|95.0|-0.65|0.26|||||Computed using linear regression, directly adjusted for referral source (not collapsed), vitamin use (not collapsed), preeclampsia, and asthma because propensity score adjustment was not balanced.|||0.26|-0.65|
73945727|NCT00116272|147423894|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|21.79|||||TWO_SIDED|95.0|-83.32|126.91|||||Computed using linear regression, directly adjusted for asthma, RA2 severity score at 32 weeks, and disease severity score imputation indicator because propensity score adjustment was not balanced.|||126.91|-83.32|
73945728|NCT00116272|147423895|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.1|||||TWO_SIDED|95.0|-0.44|0.63|||||Computed using linear regression, adjusted for propensity score comprised of preeclampsia and asthma.|||0.63|-0.44|
73945729|NCT00116272|147423896|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-0.09|||||TWO_SIDED|95.0|-0.43|0.26|||||Computed using linear regression, adjusted for maternal age (categorical).|||0.26|-0.43|
73945730|NCT00116272|147423897|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.22|1.05|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, \& disease severity imputation indicator|||1.05|0.22|
73945731|NCT00116272|147423898|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.31|1.68|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.|||1.68|0.31|
73945732|NCT00116272|147423899|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.4|1.57|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, \& disease severity imputation indicator|||1.57|0.40|
73945733|NCT00116272|147423900|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.2|||||TWO_SIDED|95.0|-7.59|7.99|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, vitamin use, primary disease, RA disease severity score at 32 weeks, PsO disease severity score at intake \& 32 weeks, disease severity imputation indicators|||7.99|-7.59|
73945734|NCT00116272|147423901|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|1.53|||||TWO_SIDED|95.0|-5.76|8.81|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, maternal age (categorical), and referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other).|||8.81|-5.76|
73945735|NCT00116272|147423902|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.27|||||TWO_SIDED|95.0|-6.12|6.65|||||Computed using linear regression. Directly adjusted for infant sex and other autoimmune diseases because propensity score adjustment was not balanced.|||6.65|-6.12|
73945736|NCT00116272|147423903|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.37|1.62|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, RA disease severity score at 32 weeks, and disease severity score imputation indicator.|||1.62|0.37|
73945737|NCT00116272|147423904|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.43|3.14|||||Computed using logistic regression, adjusted for propensity score comprised of country (U.S., Canada), primary disease, and maternal height.|||3.14|0.43|
73945738|NCT00116272|147423905|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.29|2.65|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.|||2.65|0.29|
73945739|NCT00116272|147423906|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.47|4.02|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.|||4.02|0.47|
73945740|NCT00116272|147423908|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.65|1.69|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.|||1.69|0.65|
73945741|NCT01576718|147423942|SUPERIORITY_OR_OTHER|||||||0.0604||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.0604
73945742|NCT01576718|147423942|SUPERIORITY_OR_OTHER||LSM difference|0.072||||0.0637|TWO_SIDED|95.0|-0.004|0.149||Significance at the 0.05 level.|mixed model for repeated measures||Fp 400 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.149|-0.004|0.0637
73945743|NCT01576718|147423942|SUPERIORITY_OR_OTHER||LSM difference|0.056||||0.1585|TWO_SIDED|95.0|-0.022|0.133||Significance at the 0.05 level|mixed model for repeated measures||Fp 200 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.133|-0.022|0.1585
73945744|NCT01576718|147423942|SUPERIORITY_OR_OTHER||LSM difference|0.048||||0.2221|TWO_SIDED|95.0|-0.029|0.124||Significance at the 0.05 level|mixed model for repeated measures||Fp 100 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.124|-0.029|0.2221
73869810|NCT04038567|147283341|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|95.0|-2.29|-0.15||||||||-0.15|-2.29|
73869811|NCT04038567|147283341|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.77|0.37||||||||0.37|-1.77|
73869812|NCT04038567|147283342|SUPERIORITY||Mean Difference (Final Values)|-1.58|||||TWO_SIDED|95.0|-4.41|1.25||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.25|-4.41|
73869813|NCT04038567|147283342|SUPERIORITY||Mean Difference (Final Values)|-0.42|||||TWO_SIDED|95.0|-3.26|2.42||||||Values are change in model-estimated means for hig vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.42|-3.26|
73869814|NCT04038567|147283342|SUPERIORITY||Mean Difference (Final Values)|1.49|||||TWO_SIDED|95.0|-1.35|4.33||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||4.33|-1.35|
73869815|NCT04038567|147283347|SUPERIORITY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-0.62|1.78||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.78|-0.62|
73869816|NCT04038567|147283347|SUPERIORITY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|-0.47|1.92||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.92|-0.47|
73869817|NCT04038567|147283347|SUPERIORITY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.0|1.39||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.39|-1.00|
73869818|NCT04038567|147283348|SUPERIORITY||Mean Difference (Final Values)|0.91|||||TWO_SIDED|95.0|-0.45|2.27||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.27|-0.45|
73869819|NCT04038567|147283348|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-1.33|1.38||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.38|-1.33|
73869820|NCT04038567|147283348|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.72|0.99||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.99|-1.72|
73869821|NCT04038567|147283349|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.3|0.3||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.30|-1.30|
73869822|NCT04038567|147283349|SUPERIORITY||Mean Difference (Final Values)|-0.53|||||TWO_SIDED|95.0|-1.33|0.27||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.27|-1.33|
73869823|NCT04038567|147283349|SUPERIORITY||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.55|1.05||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.05|-.55|
74039465|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2||0.3523|TWO_SIDED|95.0|-0.56|0.2|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.20|-0.56|0.3523
73869824|NCT04038567|147283350|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.41|0.41||||||||0.41|-1.41|
73869825|NCT04038567|147283350|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.27|0.55||||||||0.55|-1.27|
73869826|NCT04038567|147283350|SUPERIORITY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.4|1.42||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.42|-0.40|
73869827|NCT04038567|147283351|SUPERIORITY||Mean Difference (Final Values)|2.33|||||TWO_SIDED|95.0|-3.25|7.91||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||7.91|-3.25|
73869828|NCT04038567|147283351|SUPERIORITY||Mean Difference (Final Values)|4.82|||||TWO_SIDED|95.0|-0.76|10.4||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||10.40|-0.76|
73869829|NCT04038567|147283351|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-5.6|5.56||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||5.56|-5.60|
73869830|NCT04038567|147283352|SUPERIORITY||Mean Difference (Final Values)|3.18|||||TWO_SIDED|95.0|-3.01|9.37||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||9.37|-3.01|
74031755|NCT00431847|147616787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6873|STANDARD_ERROR_OF_MEAN|0.4482||0.1261|TWO_SIDED|95.0|-0.1943|1.5689|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.5689|-0.1943|0.1261
73869831|NCT04038567|147283352|SUPERIORITY||Mean Difference (Final Values)|1.28|||||TWO_SIDED|95.0|-4.92|7.47||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||7.47|-4.92|
74031756|NCT00431847|147616788|SUPERIORITY_OR_OTHER||Slope|-0.4831|STANDARD_ERROR_OF_MEAN|0.1243||0.0002|TWO_SIDED|95.0|-0.7286|-0.2377|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.2377|-0.7286|0.0002
74031757|NCT00431847|147616788|SUPERIORITY_OR_OTHER||Chi-Squared|3.2||||0.3617|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3617
74031758|NCT00431847|147616788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.1574|STANDARD_ERROR_OF_MEAN|2.7573||0.2532|TWO_SIDED|95.0|-2.2715|8.5863|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||8.5863|-2.2715|0.2532
74031759|NCT00431847|147616788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2227|STANDARD_ERROR_OF_MEAN|3.9633||0.758|TWO_SIDED|95.0|-6.5833|9.0286|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||9.0286|-6.5833|0.7580
74031760|NCT00431847|147616788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.1649|STANDARD_ERROR_OF_MEAN|5.3759||0.1837|TWO_SIDED|95.0|-17.7484|3.4187|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.4187|-17.7484|0.1837
74031761|NCT00431847|147616789|SUPERIORITY_OR_OTHER||Slope|0.4741|STANDARD_ERROR_OF_MEAN|0.03909|<|0.0001|TWO_SIDED|95.0|0.3971|0.5511|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.5511|0.3971|<0.0001
74031762|NCT00431847|147616789|SUPERIORITY_OR_OTHER||Chi-Squared|1.83||||0.6075|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6075
74089252|NCT02697773|147731607|SUPERIORITY||Least Square Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.53|-0.68|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.68|-1.53|<.0001
73869832|NCT04038567|147283352|SUPERIORITY||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-6.09|6.3||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||6.30|-6.09|
73869833|NCT04038567|147283359|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-5.26|-0.13||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.13|-5.26|
73869834|NCT04038567|147283359|SUPERIORITY||Mean Difference (Final Values)|-1.89|||||TWO_SIDED|95.0|-4.46|0.67||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.67|-4.46|
73869835|NCT04038567|147283359|SUPERIORITY||Mean Difference (Final Values)|-0.74|||||TWO_SIDED|95.0|-3.31|1.83||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.83|-3.31|
73869836|NCT01817959|147283362|SUPERIORITY||least square mean difference|0.001||||0.9863|TWO_SIDED|99.75|-0.205|0.207||Treatment p value|ANOVA|||||0.207|-0.205|0.9863
73869837|NCT01817959|147283363|SUPERIORITY||least square mean difference|0.024||||0.7115|TWO_SIDED|99.75|-0.184|0.232||Treatment p value|ANOVA|||||0.232|-0.184|0.7115
73945745|NCT01576718|147423942|SUPERIORITY_OR_OTHER||LSM difference|0.006|||=|0.8694|TWO_SIDED|95.0|-0.07|0.083||Significance at the 0.05 level|mixed model for repeated measures||Fp 50 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.083|-0.070|=0.8694
73945746|NCT01576718|147423943|SUPERIORITY_OR_OTHER|||||||0.1512||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.1512
73945747|NCT01576718|147423943|SUPERIORITY_OR_OTHER||LSM difference|7.36||||0.2361|TWO_SIDED|95.0|-4.83|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.56|-4.83|0.2361
73945748|NCT01576718|147423943|SUPERIORITY_OR_OTHER||LSM difference|7.78||||0.2169|TWO_SIDED|95.0|-4.59|20.15|||Regression, Linear|Significance at the 0.05 level||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||20.15|-4.59|0.2169
73945749|NCT01576718|147423943|SUPERIORITY_OR_OTHER||LSM difference|7.09||||0.2523|TWO_SIDED|95.0|-5.07|19.26||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.26|-5.07|0.2523
73945750|NCT01576718|147423943|SUPERIORITY_OR_OTHER||LSM difference|8.23||||0.1858|TWO_SIDED|95.0|-3.98|20.45||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||20.45|-3.98|0.1858
74089253|NCT02697773|147731607|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0057|TWO_SIDED|95.0|-1.07|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.18|-1.07|0.0057
73869838|NCT01817959|147283364|SUPERIORITY||Odds Ratio, log|0.21||||0.1346|TWO_SIDED|95.0|0.03|1.63||Treatment p value|Regression, Logistic|||Analytical statistics are reported for Day 75 after transplant 2||1.63|0.03|0.1346
73869839|NCT01817959|147283365|SUPERIORITY||Odds Ratio (OR)|0.91||||0.913|TWO_SIDED|95.0|0.17|4.93||Treatment p value|Regression, Logistic|||||4.93|0.17|0.9130
73869840|NCT01817959|147283366|SUPERIORITY||Odds Ratio (OR)|0.65||||0.5467|TWO_SIDED|95.0|0.16|2.66||Treatment p value|Regression, Logistic|||||2.66|0.16|0.5467
73869841|NCT01817959|147283367|SUPERIORITY|||||||0.1383|||||||Fisher Exact|||||||0.1383
73869842|NCT01817959|147283369|SUPERIORITY||least square mean difference|-0.021||||0.6952|TWO_SIDED|95.0|-0.13|0.088||Treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 1)||0.088|-0.130|0.6952
73869843|NCT01817959|147283369|SUPERIORITY||least square mean difference|0.028||||0.556|TWO_SIDED|95.0|-0.068|0.124||This is a treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 2)||0.124|-0.068|0.5560
73869844|NCT01817959|147283369|SUPERIORITY||least square mean difference|0.056||||0.2537|TWO_SIDED|95.0|-0.042|0.154||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)||0.154|-0.042|0.2537
73869845|NCT01817959|147283370|SUPERIORITY||least square mean difference|-7.4||||0.591|TWO_SIDED|95.0|-35.2|20.3||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)||20.3|-35.2|0.5910
73945751|NCT01576718|147423944|SUPERIORITY_OR_OTHER|||||||0.2879||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.2879
73976047|NCT04701203|147497103|SUPERIORITY||||||=|0.0061|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0061
73869846|NCT01817959|147283370|SUPERIORITY||least square mean difference|4.2||||0.5966|TWO_SIDED|95.0|-11.8|20.2||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 75 (Transplant 2)||20.2|-11.8|0.5966
73869847|NCT01817959|147283370|SUPERIORITY||least square mean difference|6.1||||0.5005|TWO_SIDED|95.0|-12.1|24.4||Treatment p value|ANCOVA|||This is the analytic statics for Day 365 (last Transplant)||24.4|-12.1|0.5005
73869848|NCT01817959|147283371|SUPERIORITY||least square mean difference|0.21||||0.3253|TWO_SIDED|95.0|-0.21|0.63||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)||0.63|-0.21|0.3253
73869849|NCT01817959|147283371|SUPERIORITY||least square mean difference|0.16||||0.6069|TWO_SIDED|95.0|-0.46|0.78||Treatment p value|least square mean difference|||This is the analytic statics for Day 75 (Transplant 2)||0.78|-0.46|0.6069
73869850|NCT01817959|147283371|SUPERIORITY||Least square mean difference|0.17||||0.6437|TWO_SIDED|95.0|-0.56|0.93||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)||0.93|-0.56|0.6437
73869851|NCT01817959|147283372|SUPERIORITY||least square mean difference|2.0||||0.429|TWO_SIDED|95.0|-3.0|6.9||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 1)||6.9|-3.0|0.4290
73869852|NCT01817959|147283372|SUPERIORITY||least square mean difference|1.0||||0.7853|TWO_SIDED|95.0|-6.3|8.3||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 2)||8.3|-6.3|0.7853
73869853|NCT01817959|147283372|SUPERIORITY||least square mean difference|1.9||||0.6583|TWO_SIDED|95.0|-6.6|10.4||Treatment p value|ANCOVA|||This is the analytic statistics for Day 365 (last Transplant)||10.4|-6.6|0.6583
73869854|NCT01817959|147283376|SUPERIORITY||Least square mean difference|0.0||||0.9949|TWO_SIDED|95.0|-1.28|1.28||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)||1.28|-1.28|0.9949
73869855|NCT01817959|147283376|SUPERIORITY||Least square mean difference|0.1||||0.8753|TWO_SIDED|95.0|-1.18|1.38||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)||1.38|-1.18|0.8753
73869856|NCT01817959|147283376|SUPERIORITY||Least square mean difference|-0.59||||0.3955|TWO_SIDED|95.0|-1.97|0.8||Treatment p value|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)||0.80|-1.97|0.3955
73869857|NCT01817959|147283377|SUPERIORITY||Least square mean difference|-0.105||||0.2444|TWO_SIDED|95.0|-0.286|0.075||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)||0.075|-0.286|0.2444
73869858|NCT01817959|147283377|SUPERIORITY||Least square mean difference|-0.218||||0.0328|TWO_SIDED|95.0|-0.417|-0.019||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)||-0.019|-0.417|0.0328
73869859|NCT01817959|147283377|SUPERIORITY||Least square mean difference|-0.177||||0.1059|TWO_SIDED|95.0|-0.393|0.039||This is the analytic statistics for Day 75 (Transplant 2)|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)||0.039|-0.393|0.1059
73945752|NCT01576718|147423944|SUPERIORITY_OR_OTHER||LSM difference|7.56||||0.2166|TWO_SIDED|95.0|-4.45|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.56|-4.45|0.2166
73945753|NCT01576718|147423944|SUPERIORITY_OR_OTHER||LSM difference|4.03||||0.5167|TWO_SIDED|95.0|-8.17|16.23||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||16.23|-8.17|0.5167
73945754|NCT01576718|147423944|SUPERIORITY_OR_OTHER||LSM difference|2.99||||0.6258|TWO_SIDED|95.0|-9.06|15.05||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||15.05|-9.06|0.6258
73945755|NCT01576718|147423944|SUPERIORITY_OR_OTHER||LSM difference|0.39||||0.9487|TWO_SIDED|95.0|-11.6|12.39||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||12.39|-11.60|0.9487
73945756|NCT01576718|147423945|SUPERIORITY_OR_OTHER|||||||0.0341||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0341
73869860|NCT01128946|147283412|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.06|||<|0.0001|TWO_SIDED|95.0|19.63|26.48||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||26.48|19.63|<0.0001
73869861|NCT01128946|147283413|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.75|||<|0.0001|TWO_SIDED|95.0|7.33|14.17||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.17|7.33|<0.0001
73976048|NCT04701203|147497104|SUPERIORITY||||||=|0.0347|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0347
73869862|NCT01128946|147283413|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.2|||<|0.0001|TWO_SIDED|95.0|8.74|15.67||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.67|8.74|<0.0001
73869863|NCT01128946|147283413|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.31|||<|0.0001|TWO_SIDED|95.0|8.9|15.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.72|8.90|<0.0001
73945757|NCT01576718|147423945|SUPERIORITY_OR_OTHER|||||||0.034||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0340
73945758|NCT01576718|147423945|SUPERIORITY_OR_OTHER|||||||0.0058||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0058
73945759|NCT01576718|147423945|SUPERIORITY_OR_OTHER|||||||0.0018||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0018
73945760|NCT01576718|147423945|SUPERIORITY_OR_OTHER|||||||0.1006||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.1006
74039466|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.4403|TWO_SIDED|95.0|-0.53|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.23|-0.53|0.4403
73869864|NCT01128946|147283413|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.46||||0.407|TWO_SIDED|95.0|-2.0|4.91||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||4.91|-2.00|0.4070
73869865|NCT01128946|147283413|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.85|||<|0.0001|TWO_SIDED|95.0|-14.3|-7.4||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||-7.40|-14.30|<0.0001
73869866|NCT01128946|147283414|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.21|||<|0.0001|TWO_SIDED|95.0|11.46|14.96||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||14.96|11.46|<0.0001
73869867|NCT01128946|147283414|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.79|||<|0.0001|TWO_SIDED|95.0|7.04|10.55||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||10.55|7.04|<0.0001
73869868|NCT01128946|147283414|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.03|||<|0.0001|TWO_SIDED|95.0|6.25|9.8||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||9.80|6.25|<0.0001
73869869|NCT01128946|147283414|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.41|||<|0.0001|TWO_SIDED|95.0|2.66|6.16||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||6.16|2.66|<0.0001
73869870|NCT01128946|147283414|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.77||||0.3942|TWO_SIDED|95.0|-2.54|1.0||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||1.00|-2.54|0.3942
73869871|NCT01128946|147283414|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.18|||<|0.0001|TWO_SIDED|95.0|-6.95|-3.41||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||-3.41|-6.95|<0.0001
73869872|NCT01371734|147283415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85||||0.587|TWO_SIDED|95.0|-2.23|3.94|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose||3.94|-2.23|0.587
73869873|NCT01371734|147283415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52||||0.333|TWO_SIDED|95.0|-1.56|4.61|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose||4.61|-1.56|0.333
74039467|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3205|TWO_SIDED|95.0|-0.58|0.19|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.19|-0.58|0.3205
73869874|NCT01371734|147283416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015||||0.923|TWO_SIDED|95.0|-0.29|0.32|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose||0.32|-0.29|0.923
73869875|NCT01371734|147283416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.161||||0.302|TWO_SIDED|95.0|-0.14|0.47|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose||0.47|-0.14|0.302
73869876|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.729|||||||Cochran-Mantel-Haenszel|||Week 1||||0.729
73869877|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.756|||||||Cochran-Mantel-Haenszel|||Week 1||||0.756
73869878|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.765|||||||Cochran-Mantel-Haenszel|||Week 2||||0.765
73869879|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 2||||0.475
73869880|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.31|||||||Cochran-Mantel-Haenszel|||Week 3||||0.310
73869881|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.105|||||||Chi-squared, Corrected|||Week 3||||0.105
73869882|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.254|||||||Cochran-Mantel-Haenszel|||Week 4||||0.254
73869883|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.887|||||||Cochran-Mantel-Haenszel|||Week 4||||0.887
73869884|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 6||||0.475
73869885|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.407|||||||Cochran-Mantel-Haenszel|||Week 6||||0.407
73869886|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.696|||||||Cochran-Mantel-Haenszel|||Week 8||||0.696
73869887|NCT01371734|147283417|SUPERIORITY_OR_OTHER|||||||0.462|||||||Cochran-Mantel-Haenszel|||Week 8||||0.462
73869888|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.806||||0.633|TWO_SIDED|95.0|0.333|1.951|||Regression, Logistic|||Week 1||1.951|0.333|0.633
73945761|NCT01576718|147423946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.88116|TWO_SIDED|95.0|-11.12|12.91||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||12.91|-11.12|0.88116
73945762|NCT01576718|147423946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.98||||0.05977|TWO_SIDED|95.0|-22.64|0.68||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||0.68|-22.64|0.05977
73945763|NCT01576718|147423946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.90426|TWO_SIDED|95.0|-13.02|11.54||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||11.54|-13.02|0.90426
73945764|NCT01576718|147423946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38||||0.4731|TWO_SIDED|95.0|-16.57|7.82||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||7.82|-16.57|0.47310
73945765|NCT01576718|147423953|SUPERIORITY_OR_OTHER||LSM difference|0.019|||=|0.6161|TWO_SIDED|95.0|-0.057|0.096||0.05 level of significance.|mixed model for repeated measures|||||0.096|-0.057|=0.6161
73945766|NCT01576718|147423953|SUPERIORITY_OR_OTHER||LSM difference|0.004||||0.9245|TWO_SIDED|95.0|-0.973|0.08||0.05 level of significance.|mixed model for repeated measures|||||0.080|-0.973|0.9245
74089254|NCT02697773|147731607|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.0114|TWO_SIDED|95.0|-1.02|-0.13|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.13|-1.02|0.0114
73945767|NCT01576718|147423953|SUPERIORITY_OR_OTHER||LSM difference|-0.008||||0.8434|TWO_SIDED|95.0|-0.083|0.068||0.05 level of significance.|mixed model for repeated measures|||||0.068|-0.083|0.8434
73945768|NCT01576718|147423953|SUPERIORITY_OR_OTHER||LSM difference|-0.047||||0.2241|TWO_SIDED|95.0|-0.122|0.029||0.05 level of significance.|mixed model for repeated measures|||||0.029|-0.122|0.2241
73945769|NCT01576718|147423953|SUPERIORITY_OR_OTHER||LSM difference|-0.053||||0.1822|TWO_SIDED|95.0|-0.13|0.025||0.05 level of significance.|mixed model for repeated measures|||||0.025|-0.130|0.1822
73945770|NCT01576718|147423954|SUPERIORITY_OR_OTHER||LSM difference|-5.56||||0.3568|TWO_SIDED|95.0|-17.42|6.29||0.05 level of significance.|Regression, Linear|||||6.29|-17.42|0.3568
73869889|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.561||||0.172|TWO_SIDED|95.0|0.245|1.285|||Regression, Logistic|||Week 1||1.285|0.245|0.172
73869890|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.939||||0.826|TWO_SIDED|95.0|0.536|1.644|||Regression, Logistic|||Week 2||1.644|0.536|0.826
73869891|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.599|TWO_SIDED|95.0|0.489|1.511|||Regression, Logistic|||Week 2||1.511|0.489|0.599
73869892|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.713||||0.248|TWO_SIDED|95.0|0.402|1.265|||Regression, Logistic|||Week 3||1.265|0.402|0.248
73869893|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.564||||0.048|TWO_SIDED|95.0|0.32|0.995|||Regression, Logistic|||Week 3||0.995|0.320|0.048
73869894|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.708||||0.21|TWO_SIDED|95.0|0.412|1.216|||Regression, Logistic|||Week 4||1.216|0.412|0.210
73869895|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.964||||0.893|TWO_SIDED|95.0|0.564|1.646|||Regression, Logistic|||Week 4||1.646|0.564|0.893
73869896|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.714||||0.228|TWO_SIDED|95.0|0.413|1.235|||Regression, Logistic|||Week 6||1.235|0.413|0.228
73869897|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.916||||0.751|TWO_SIDED|95.0|0.531|1.579|||Regression, Logistic|||Week 6||1.579|0.531|0.751
73869898|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.974||||0.925|TWO_SIDED|95.0|0.561|1.689|||Regression, Logistic|||Week 8||1.689|0.561|0.925
73869899|NCT01371734|147283418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.764||||0.342|TWO_SIDED|95.0|0.438|1.331|||Regression, Logistic|||Week 8||1.331|0.438|0.342
73869900|NCT02467842|147283426|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|1.02|||||TWO_SIDED|95.0|0.94|1.1||||||GMR of A/H1N1 strain (GMTs of pooled TIV/QIV)||1.10|0.94|
73869901|NCT02467842|147283426|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|0.94|||||TWO_SIDED|95.0|0.87|1.01||||||GMR of A/H3N2 strain (GMTs of pooled TIV/QIV)||1.01|0.87|
73869902|NCT02467842|147283426|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.88|||||TWO_SIDED|95.0|0.82|0.95||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)||0.95|0.82|
73869903|NCT02467842|147283426|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.9|||||TWO_SIDED|95.0|0.83|0.97||||||GMR of A/H1N1 strain (GMTs of TIV/QIV)||0.97|0.83|
73869904|NCT02467842|147283427|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-1.0|||||TWO_SIDED|95.0|-6.07|4.06||||||Diff. SCR of A/H1N1 strain (SCR of pooled TIV minus QIV)||4.06|-6.07|
73869905|NCT02467842|147283427|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-5.02|||||TWO_SIDED|95.0|-10.08|0.04||||||Diff. SCR of A/H3N2 strain (SCR of pooled TIV minus QIV)||0.04|-10.08|
73869906|NCT02467842|147283427|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-7.06|||||TWO_SIDED|95.0|-13.12|-1.0||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)||-1.00|-13.12|
73869907|NCT02467842|147283427|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-3.09|||||TWO_SIDED|95.0|-9.26|3.09||||||Diff. SCR of B/Victoria (SCR of TIV minus QIV)||3.09|-9.26|
73945771|NCT01576718|147423954|SUPERIORITY_OR_OTHER||LSM difference|-5.68||||0.3531|TWO_SIDED|95.0|-17.67|6.32||0.05 level of significance.|Regression, Linear|||||6.32|-17.67|0.3531
73945772|NCT01576718|147423954|SUPERIORITY_OR_OTHER||LSM difference|-6.58||||0.2724|TWO_SIDED|95.0|-18.35|5.19||0.05 level of significance.|Regression, Linear|||||5.19|-18.35|0.2724
73945773|NCT01576718|147423954|SUPERIORITY_OR_OTHER||LSM difference|-5.11|||=|0.3964|TWO_SIDED|95.0|-16.95|6.72||0.05 level of significance.|Regression, Linear|||||6.72|-16.95|=0.3964
73945774|NCT01576718|147423954|SUPERIORITY_OR_OTHER||LSM difference|-13.45||||0.0296|TWO_SIDED|95.0|-25.57|-1.33||0.05 level of significance.|Regression, Linear|||||-1.33|-25.57|0.0296
73945775|NCT01576718|147423955|SUPERIORITY_OR_OTHER||LSM difference|-0.69||||0.9101|TWO_SIDED|95.0|-12.59|11.22||0.05 level of significance.|Regression, Linear|||||11.22|-12.59|0.9101
73945776|NCT01576718|147423955|SUPERIORITY_OR_OTHER||LSM difference|-4.51||||0.4634|TWO_SIDED|95.0|-16.6|7.57||0.05 level of significance.|Regression, Linear|||||7.57|-16.6|0.4634
73945777|NCT01576718|147423955|SUPERIORITY_OR_OTHER||LSM difference|-5.88||||0.3333|TWO_SIDED|95.0|-17.8|6.05||0.05 level of significance.|Regression, Linear|||||6.05|-17.8|0.3333
73869908|NCT02467842|147283431|SUPERIORITY|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||TWO_SIDED|95.0|0.7|0.81||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)||0.81|0.70|
73869909|NCT02467842|147283431|SUPERIORITY|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||TWO_SIDED|95.0|0.69|0.81||||||GMR of B/Victoria (GMTs of TIV/QIV)||0.81|0.69|
73869910|NCT02467842|147283432|SUPERIORITY|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-18.98|||||TWO_SIDED|95.0|-24.61|-13.36||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)||-13.36|-24.61|
73869911|NCT02467842|147283432|SUPERIORITY|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-12.62|||||TWO_SIDED|95.0|-18.79|-6.45||||||Diff. SCR of B/Victoria strain (SCR of TIV minus QIV)||-6.45|-18.79|
73945778|NCT01576718|147423955|SUPERIORITY_OR_OTHER||LSM difference|-8.19||||0.1763|TWO_SIDED|95.0|-20.06|3.69||0.05 level of significance.|Regression, Linear|||||3.69|-20.06|0.1763
73945779|NCT01576718|147423955|SUPERIORITY_OR_OTHER||Slope|-9.05||||0.1469|TWO_SIDED|95.0|-21.3|3.19||0.05 level of significance.|Regression, Linear|||||3.19|-21.3|0.1469
73945780|NCT01742364|147423956|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).||||0.475
73945781|NCT01742364|147423956|SUPERIORITY_OR_OTHER|||||||0.187|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).||||0.187
73945782|NCT01742364|147423958|SUPERIORITY_OR_OTHER|||||||0.205|||||||Wilcoxon (Mann-Whitney)|||||||0.205
73945783|NCT01742364|147423959|SUPERIORITY_OR_OTHER|||||||0.325|||||||Wilcoxon (Mann-Whitney)|||||||0.325
73945784|NCT01742364|147423960|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
73945785|NCT01742364|147423960|SUPERIORITY_OR_OTHER|||||||0.13|||||||Kruskal-Wallis|||||||0.130
73945786|NCT01742364|147423961|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||||||0.001
73945787|NCT01742364|147423961|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||||||0.003
73945788|NCT00201864|147423986|SUPERIORITY_OR_OTHER|||||||0.9102|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9102
73945789|NCT04382924|147423996|SUPERIORITY||Odds Ratio, log|0.0001|||<|0.025|TWO_SIDED||||||Chi-squared|||||||<0.025
73945790|NCT01559454|147424008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.4167||||0.097|TWO_SIDED|95.0|-8.7519|79.5852|||t-test, 2 sided|||||79.5852|-8.7519|0.097
73945791|NCT01559454|147424009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||1|TWO_SIDED|95.0|0.0713|1.8248|||Fisher Exact|||||1.8248|0.0713|1.00
73945792|NCT01559454|147424010|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.55075||||0.348|TWO_SIDED|95.0|-20.37051|51.34968|||t-test, 2 sided|||||51.34968|-20.37051|0.348
73945793|NCT01559454|147424011|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|39.5833||||0.088|TWO_SIDED|95.0|-7.9653|87.132|||t-test, 2 sided|||||87.1320|-7.9653|0.088
73945794|NCT01559454|147424012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1499||||0.895|TWO_SIDED|95.0|-30.3965|27.0632|||t-test, 2 sided|||||27.0632|-30.3965|0.895
73945795|NCT01559454|147424013|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.6||||0.6999|TWO_SIDED|95.0|0.127|2.8352|||Fisher Exact|||||2.8352|0.127|0.6999
73945796|NCT02207725|147424014|SUPERIORITY||Hodges-Lehman estimate of shift|-74.55|||<|0.0001|TWO_SIDED|95.0|-78.39|-66.28|||2-sided test exact Wilcoxon rank-sum tes|||||-66.28|-78.39|<0.0001
73945797|NCT02207725|147424014|SUPERIORITY||Hodges-Lehman estimate of shift|-59.5|||<|0.0001|TWO_SIDED|95.0|-64.1|-55.17|||2-sided test exact Wilcoxon rank-sum tes|||||-55.17|-64.10|<0.0001
73945798|NCT02207725|147424015|SUPERIORITY||Hodges-Lehman estimate of shift|-77.14|||<|0.0001|TWO_SIDED|95.0|-79.98|-74.04|||2-sided test exact Wilcoxon rank-sum tes|||||-74.04|-79.98|<0.0001
73869912|NCT02708355|147283441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.028||||0.0442|TWO_SIDED|95.0|1.001|1.055|||Regression, Logistic|||Association between percentage of time with intragastric pH\>4 and relief of 24 -hour heartburn was assessed using logistic regression model with relief of 24- hour heartburn at Day 14 as dependent variable and change in percentage of time with intragastric pH\>4 as the independent variable, controlling for age, sex, and body mass index (BMI).||1.055|1.001|0.0442
73945799|NCT02207725|147424017|SUPERIORITY||Hodges-Lehman estimate of shift|-7.09|||<|0.0001|TWO_SIDED|95.0|-8.86|-5.42|||2-sided test exact Wilcoxon rank-sum tes|||||-5.42|-8.86|<0.0001
73869913|NCT02669121|147283442|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|99.99|-13.181|0.997|||||||The vaccine efficacy was met if lower bound of confidence interval (CI) for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the Cox proportional hazard (PH) model. The 99.99% CI for the VE was obtained by taking 1 minus the 99.99% CI of the hazard ratio from the PH model.|0.997|-13.181|
73869914|NCT02669121|147283443|SUPERIORITY||Cox Proportional Hazard|0.618|||||TWO_SIDED|95.01|0.208|0.816|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95.01% CI for the VE was obtained by taking 1 minus the 95.01% CI of the hazard ratio from the PH model.|0.816|0.208|
73869915|NCT02669121|147283444|SUPERIORITY||Cox Proportional Hazard|0.618|||||TWO_SIDED|95.0|0.208|0.816|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95% CI for the VE was obtained by taking 1 minus the 95% CI of the hazard ratio from the PH model.|0.816|0.208|
73945800|NCT02207725|147424017|SUPERIORITY||Hodges-Lehman estimate of shift|-3.02||||0.0002|TWO_SIDED|95.0|-5.66|-1.25|||2-sided test exact Wilcoxon rank-sum tes|||||-1.25|-5.66|0.0002
73945801|NCT02207725|147424018|SUPERIORITY||Hodges-Lehman estimate of shift|1227.35|||<|0.0001|TWO_SIDED|95.0|984.01|1456.38|||2-sided test exact Wilcoxon rank-sum tes|||||1456.38|984.01|<0.0001
73945802|NCT02207725|147424018|SUPERIORITY||Hodges-Lehman estimate of shift|999.33|||<|0.0001|TWO_SIDED|95.0|819.5|1200.53|||2-sided test exact Wilcoxon rank-sum tes|||||1200.53|819.50|<0.0001
73945803|NCT01966003|147424020|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence of the primary endpoint was demonstrated by comparing the 2-sided 90% CI of the risk ratio in objective response rate between ABP 215 and bevacizumab with an equivalence margin of (0.67, 1.5).|Risk Ratio (RR)|0.93|||||TWO_SIDED|90.0|0.8|1.09||||||The risk ratio (ABP 215/Bevacizumab) and 90% confidence interval (CI) were estimated using a generalized linear model adjusted for the stratification factors (region, sex, and ECOG performance status).||1.09|0.80|
73945804|NCT01966003|147424020|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.9|||||TWO_SIDED|90.0|-9.26|3.45||||||Risk difference (ABP 215 - Bevacizumab) and 90% CI were estimated using a generalized linear model adjusted for the randomization stratification factors geographic region, ECOG performance status, and sex.||3.45|-9.26|
73945805|NCT01966003|147424022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|90.0|0.83|1.29||||||The hazard ratio for ABP 215 relative to bevacizumab was based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.||1.29|0.83|
73945806|NCT01966003|147424025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.75|1.61||||||Hazard ratio for ABP 215 relative to bevacizumab, based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.||1.61|0.75|
73945807|NCT00615264|147424031|SUPERIORITY_OR_OTHER|||||||0.2851|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix||||||0.2851
73945808|NCT00615264|147424032|SUPERIORITY_OR_OTHER|||||||0.769|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix||||||0.7690
73945809|NCT01187914|147424033|SUPERIORITY_OR_OTHER||Regression coefficient|0.13||||0.48||95.0|||||Regression, Linear|||||||0.48
73945810|NCT02150837|147424062|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Within group comparison (for each group) using a non-parametric paired Wilcoxon signed rank test comparing repeated measures in a single sample.||||||<0.0001
73945811|NCT00659984|147424255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.2||||0.363|TWO_SIDED|95.0|-3.4|13.9|||Cochran Armitage Trend Test|||||13.9|-3.4|0.363
73945812|NCT03802864|147424256|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
73945813|NCT03802864|147424257|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
74039468|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5763|TWO_SIDED|95.0|-0.51|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.28|-0.51|0.5763
73945814|NCT03802864|147424258|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
73945815|NCT03802864|147424259|SUPERIORITY|||||||0.28|||||||Regression, Linear|||||||0.28
73945816|NCT03802864|147424260|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
73945817|NCT03802864|147424261|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
73945818|NCT03802864|147424262|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
73945819|NCT00985985|147424275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.3851|TWO_SIDED|95.0|0.78|1.92|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center)|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.||1.92|0.78|0.3851
73945820|NCT00985985|147424275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.0565|TWO_SIDED|95.0|0.99|3.32|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center).|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.||3.32|0.99|0.0565
73945821|NCT01856712|147424283|SUPERIORITY||Odds Ratio (OR)|1.71|||||TWO_SIDED|95.0|0.35|9.98||||||||9.98|0.35|
73945822|NCT00509236|147424288|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.||||<0.001
73869916|NCT02669121|147283445|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|-0.711|0.977|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95% CI for the VE was obtained by taking 1 minus the 95% CI of the hazard ratio from the PH model.|0.977|-0.711|
73869917|NCT03216746|147283446|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
73869918|NCT00241904|147283489|SUPERIORITY||||||<|0.001|||||||General Linear Mixed Model|||Intention to treat analysis was used||||<0.001
73869919|NCT00241904|147283490|SUPERIORITY|||||||0.003|||||||General Linear Mixed Model|||||||0.003
73945823|NCT00509236|147424289|SUPERIORITY_OR_OTHER||Difference in % Affected|-4.8||||0.336|TWO_SIDED|95.0|-15.7|5.6||Miettinen \& Nurminen method stratified by prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent).|Miettinen & Nurminen|||||5.6|-15.7|0.336
73869920|NCT00241904|147283491|SUPERIORITY|||||||0.034|||||||General Linear Mixed Model|||||||0.034
73945824|NCT00509236|147424290|SUPERIORITY_OR_OTHER||Difference in % Affected|2.8|||||TWO_SIDED|95.0|-10.9|16.5||||||||16.5|-10.9|
73945825|NCT00509236|147424291|SUPERIORITY_OR_OTHER||Change from Baseline in LS Mean|-26.6|||<|0.001|TWO_SIDED|95.0|-38.0|-15.3|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||-15.3|-38.0|<0.001
73945826|NCT00509236|147424291|SUPERIORITY_OR_OTHER||Change from Baseline in LS Mean|-31.2|||<|0.001|TWO_SIDED|95.0|-42.6|-19.9|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||-19.9|-42.6|<0.001
73945827|NCT00509236|147424291|SUPERIORITY_OR_OTHER||Difference in LS Means|4.6|||||TWO_SIDED|95.0|-11.5|20.7||||||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||20.7|-11.5|
73945828|NCT00509236|147424292|SUPERIORITY_OR_OTHER||Difference in LS Means|0.15|||||TWO_SIDED|95.0|-0.18|0.49|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.||0.49|-0.18|
73976049|NCT06140290|147497108|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|108.32|||||TWO_SIDED|90.0|101.2|115.94|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||115.94|101.20|
74009015|NCT01641237|147568705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|||<|0.0001|TWO_SIDED|95.0|1.42|1.9||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.90|1.42|<0.0001
73869921|NCT00241904|147283492|SUPERIORITY||||||<|0.001|||||||General Linear Mixed Model|||||||<0.001
73869922|NCT04000581|147283508|SUPERIORITY|||||||0.329|||||||t-test, 1 sided|||The null hypothesis is that the mean change is equal between the groups, while the alternative is that an increased difference is observed in arm 2. The hypotheses are evaluated using a one-sided, two-sample t-test.||||0.329
73869923|NCT00588354|147283519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|1.05||0.159|TWO_SIDED|95.0|-0.52|3.6|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||3.60|-0.52|0.159
73869924|NCT00588354|147283520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.97||0.91|TWO_SIDED|95.0|-1.79|2.01|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||2.01|-1.79|0.910
74009016|NCT01641237|147568705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.6|||<|0.0001|TWO_SIDED|95.0|1.36|1.85||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.85|1.36|<0.0001
73869925|NCT00588354|147283521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.96|STANDARD_ERROR_OF_MEAN|2.04||0.162|TWO_SIDED|95.0|-1.04|6.96|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||6.96|-1.04|0.162
73869926|NCT00588354|147283522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.67|STANDARD_ERROR_OF_MEAN|2.27||0.022|TWO_SIDED|95.0|1.22|10.12|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||10.12|1.22|0.022
73869927|NCT00588354|147283523|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.86|STANDARD_ERROR_OF_MEAN|3.28||0.089|TWO_SIDED|95.0|-0.57|12.29|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||12.29|-0.57|0.089
73945829|NCT03587142|147424317|SUPERIORITY||Mean Difference (Net)|-0.11||||0.69|TWO_SIDED|95.0|-0.68|0.45||Nominal P value. Power was determined at a level of P=0.05.|ANCOVA|Multiple imputation using regression and 50 datasets to estimate the outcome for the 18/96 (19%) randomized patients without the f4 visit data.||Primary outcome analysis uses a difference of differences analysis between Buspirone compared to the Placebo arm in which the adjusted mean difference of differences, Wald 95% Confidence interval and 2-sided P values are determined from a Wald Chi-Square test. Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Negative change indicates symptom improvement.||0.45|-0.68|0.69
73945830|NCT03587142|147424317|SUPERIORITY||Mean Difference (Net)|-0.13||||0.62|TWO_SIDED|95.0|-0.65|0.39||P value is nominal; no adjustments made from multiple comparisons. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005.|ANCOVA|||Sensitivity analysis of change from a baseline in ES/PPF (Early Satiety/Postprandial Fullness subscore) using all completers: 39 participants in Buspirone arm, 39 participants in placebo arm.||0.39|-0.65|0.62
73869928|NCT00588354|147283524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.04|STANDARD_ERROR_OF_MEAN|3.17||0.038|TWO_SIDED|95.0|0.83|13.25|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||13.25|0.83|0.038
73976050|NCT06140290|147497109|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|120.41|||||TWO_SIDED|90.0|108.02|134.22|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||134.22|108.02|
73976051|NCT06140290|147497110|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|115.29|||||TWO_SIDED|90.0|105.17|126.38|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||126.38|105.17|
73976052|NCT06140290|147497111|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|106.75|||||TWO_SIDED|90.0|99.33|114.73|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||114.73|99.33|
73976053|NCT06140290|147497112|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|91.8|||||TWO_SIDED|90.0|77.76|108.38|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA (Analysis of variance) model with treatment as a fixed effect.||108.38|77.76|
73976054|NCT06140290|147497112|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|102.71|||||TWO_SIDED|90.0|86.33|122.19|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||122.19|86.33|
74009017|NCT01641237|147568705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.62|||<|0.0001|TWO_SIDED|95.0|0.38|0.86||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||0.86|0.38|<0.0001
74009018|NCT01641237|147568705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05||||0.668|TWO_SIDED|95.0|-0.19|0.29||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||0.29|-0.19|0.6680
74039469|NCT02528253|147632443|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.2887|TWO_SIDED|95.0|-0.61|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.18|-0.61|0.2887
74009019|NCT01641237|147568705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.8|1.28||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.28|0.80|<0.0001
74009020|NCT01641237|147568705|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.99|||<|0.0001|TWO_SIDED|95.0|0.75|1.23||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.23|0.75|<0.0001
74009021|NCT02716675|147568717|OTHER||Prevention Efficacy (PE)|26.6||||0.15|TWO_SIDED|95.0|-11.7|51.8||The threshold for statistical significance was p = 0.05.|wald|||The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.||51.8|-11.7|0.15
74009022|NCT02716675|147568717|OTHER||Prevention Efficacy (PE)|22.4|||||TWO_SIDED|95.0|-25.5|52.0||||||A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.||52.0|-25.5|
74009023|NCT02716675|147568717|OTHER||Prevention Efficacy (PE)|30.9|||||TWO_SIDED|95.0|-13.9|58.0||||||A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.||58.0|-13.9|
74009024|NCT02716675|147568719|OTHER||Prevention Efficacy (PE)|73.0|||||TWO_SIDED|95.0|27.6|89.9||||||PE against IC80 of least sensitive variant less than 1||89.9|27.6|
74009025|NCT02716675|147568719|OTHER||Prevention Efficacy (PE)|6.1|||||TWO_SIDED|95.0|-174.3|67.8||||||PE against IC80 of least sensitive variant 1-3||67.8|-174.3|
74009026|NCT02716675|147568719|OTHER||Prevention Efficacy (PE)|8.6|||||TWO_SIDED|95.0|-68.1|50.3||||||PE against IC80 of least sensitive variant \> 3||50.3|-68.1|
73869929|NCT00588354|147283525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.83|STANDARD_ERROR_OF_MEAN|3.53||0.186|TWO_SIDED|95.0|-11.75|2.09|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||2.09|-11.75|0.186
73869930|NCT00588354|147283526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|3.37||0.918|TWO_SIDED|95.0|-6.96|6.26|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||6.26|-6.96|0.918
73869931|NCT01736618|147283530|OTHER||Kaplan-Meier|92.9|||||ONE_SIDED|95.0|91.4|||||||"Ho: The Type I Complication Free Rate at 60 months (p1) does not exceed the performance goal of 85.0%.~Ho: p1 ≤ 85.0% Ha: The Type I Complication Free Rate at 60 months (p1) does exceed the performance goal of 85.0%.~Ha: p1 \> 85.0% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 85.0%."|||91.4|
73869932|NCT01736618|147283531|OTHER||Clopper-Pearson exact confidence bound|98.6|||||ONE_SIDED|95.0|97.4|||||||"Ho: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does not exceed the performance goal of 94.0%.~Ho: p1 ≤ 94.0% Ha: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does exceed the performance goal of 94.0%.~Ha: p1 \>94.0% The null hypothesis will be rejected if the lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 94.0%."|||97.4|
73945831|NCT03587142|147424317|SUPERIORITY||Mean Difference (Net)|-0.25||||0.62|TWO_SIDED|95.0|-0.89|0.38||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Sensitivity analyses: change in ES/PPF in treatment adherent patients: 23 participants in Buspirone arm, 29 patients in placebo arm.||0.38|-0.89|0.62
73945832|NCT03587142|147424318|SUPERIORITY||Mean Difference (Net)|-0.09||||0.76|TWO_SIDED|95.0|-0.69|0.5||Nominal P value reported. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||The mean difference of differences (DoD) between Buspirone and Placebo, 95% confidence interval and P (2-sided) were derived from an ANCOVA, regressing an indicator for treatment group on fullness severity score, adjusting for the baseline value of fullness severity score.||0.50|-0.69|0.76
73945833|NCT03587142|147424319|SUPERIORITY||Mean Difference (Net)|-0.15||||0.64|TWO_SIDED|95.0|-0.76|0.47||Nominal P values; Bonferroni p value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.47|-0.76|0.64
73945834|NCT03587142|147424320|SUPERIORITY||Mean Difference (Net)|-0.14||||0.66|TWO_SIDED|95.0|-0.79|0.5||P values are nominal; Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.50|-0.79|0.66
73976055|NCT06140290|147497113|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|86.34|||||TWO_SIDED|90.0|69.42|107.37|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||107.37|69.42|
73976056|NCT06140290|147497113|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|97.98|||||TWO_SIDED|90.0|76.99|124.7|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||124.70|76.99|
73869933|NCT01736618|147283532|OTHER||Kaplan-Meier|99.2|||||ONE_SIDED|95.0|98.8|||||||"Ho: The Electrode-Related Complication Free Rate at 60 months (p1) does not exceed the performance goal of 92.5%.~Ho: p1 ≤ 92.5% Ha: The Electrode-Related Complication Free Rate at 60 months (p1) does exceed the performance goal of 92.5%.~Ha: p1 \> 92.5% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 92.5%."|||98.8|
73945835|NCT03587142|147424321|SUPERIORITY||Mean Difference (Net)|-0.12||||0.7|TWO_SIDED|95.0|-0.75|0.5||Nominal P values; Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (s-sided) determined from a Wald Chi-Square test.||0.50|-0.75|0.70
73945836|NCT03587142|147424322|SUPERIORITY||Mean Difference (Net)|-0.2||||0.4|TWO_SIDED|95.0|-0.66|0.27||P value is nominal; no adjustments made for multiple comparisons. Bonferrini p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) of change in outcome from baseline and 95% Confidence Intervals were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. P (2-sided) were determined from a Wald Chi-Square test.||0.27|-0.66|0.40
73869934|NCT01736618|147283533|OTHER||Clopper-Pearson exact confidence bound|94.4|||||ONE_SIDED|95.0|93.5|||||||"Ho: The 1st Shock Effectiveness in Converting Induced (Acute) \& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does not exceed the performance goal of 84.0%.~Ho: p1 ≤ 84.0% Ha: The 1st Shock Effectiveness in Converting Induced (Acute) \& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does exceed the performance goal of 84.0%.~Ha: p1 \>84.0% The null hypothesis will be rejected if lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 84.0%."|||93.5|
73869935|NCT03637517|147283542|EQUIVALENCE|2 comparisons performed: Reg. B vs. Reg. A, \& Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.926||||0.4847|TWO_SIDED|90.0|0.771|1.113|||ANOVA|||||1.113|0.771|0.4847
74031763|NCT00431847|147616789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9534|STANDARD_ERROR_OF_MEAN|1.2763||0.4558|TWO_SIDED|95.0|-3.4675|1.5607|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.5607|-3.4675|0.4558
74031764|NCT00431847|147616789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3505|STANDARD_ERROR_OF_MEAN|1.977||0.0914|TWO_SIDED|95.0|-7.2442|0.5432|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.5432|-7.2442|0.0914
74031765|NCT00431847|147616789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.37|STANDARD_ERROR_OF_MEAN|3.0921||0.007|TWO_SIDED|95.0|-14.4589|-2.281|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-2.2810|-14.4589|0.007
74031766|NCT00431847|147616790|SUPERIORITY_OR_OTHER||Slope|-0.2169|STANDARD_ERROR_OF_MEAN|0.04148|<|0.0001|TWO_SIDED|95.0|-0.2987|-0.1352|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1352|-0.2987|<0.0001
73869936|NCT03637517|147283542|EQUIVALENCE|2 comparisons performed: Reg. B vs. Reg. A, \& Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.79||||0.037|TWO_SIDED|90.0|0.658|0.95|||ANOVA|||||0.950|0.658|0.0370
73869937|NCT03637517|147283543|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.899||||0.1135|TWO_SIDED|90.0|0.805|1.004|||ANOVA|||||1.004|0.805|0.1135
73869938|NCT03637517|147283543|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.175||||0.0192|TWO_SIDED|90.0|1.051|1.312|||ANOVA|||||1.312|1.051|0.0192
74031767|NCT00431847|147616790|SUPERIORITY_OR_OTHER||Chi-Squared|6.37||||0.095|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.0950
74031768|NCT00431847|147616790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7246|STANDARD_ERROR_OF_MEAN|1.3351||0.5878|TWO_SIDED|95.0|-1.9056|3.3547|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.3547|-1.9056|0.5878
73869939|NCT03637517|147283544|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.898||||0.1759|TWO_SIDED|90.0|0.787|1.024|||ANOVA||Regimen B to A|||1.024|0.787|0.1759
73869940|NCT03637517|147283544|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.172||||0.0496|TWO_SIDED|90.0|1.027|1.338|||ANOVA||Regimen C to B|||1.338|1.027|0.0496
74031769|NCT00431847|147616790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2466|STANDARD_ERROR_OF_MEAN|2.0697||0.9053|TWO_SIDED|95.0|-4.3231|3.8299|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.8299|-4.3231|0.9053
73945837|NCT03587142|147424322|SUPERIORITY||Odds Ratio (OR)|1.31||||0.56|TWO_SIDED|95.0|0.53|3.21||Nominal P value without adjustment for multiple comparisons. Bonferroni threshold for level of significance is \<0.002.|Regression, Logistic|Odds ratio, 95% C.I. and P (two-sided) from a logistic regression of the binary outcome on treatment group for symptomatic improvement in GCSI.||GCSI symptomatic improvement of 1+ points in total GCSI symptom score defined as change in GCSI total score at week 4 from baseline being a decrease of 1 or more points. This is a binary variable where 1=1+ reduction in change in GCSI total score, 0=change in GCSI total score from baseline at 4-weeks is \< 1.0.||3.21|0.53|0.56
73945838|NCT03587142|147424323|SUPERIORITY||Mean Difference (Net)|-0.05||||0.86|TWO_SIDED|95.0|-0.58|0.48||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Squares test.||0.48|-0.58|0.86
73945839|NCT03587142|147424324|SUPERIORITY||Mean Difference (Net)|-0.06||||0.85|TWO_SIDED|95.0|-0.64|0.53||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald-Chi Square test.||0.53|-0.64|0.85
73945840|NCT03587142|147424325|SUPERIORITY||Mean Difference (Net)|-0.14||||0.65|TWO_SIDED|95.0|-0.76|0.47||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test||0.47|-0.76|0.65
73945841|NCT03587142|147424326|SUPERIORITY||Mean Difference (Net)|-0.41||||0.16|TWO_SIDED|95.0|-0.99|0.16||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.16|-0.99|0.16
73945842|NCT03587142|147424327|SUPERIORITY||Mean Difference (Net)|-0.65||||0.03|TWO_SIDED|95.0|-1.23|-0.08||P values are nominal; no adjustments made for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||-0.08|-1.23|0.03
73976057|NCT06140290|147497114|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|88.72|||||TWO_SIDED|90.0|73.1|107.68|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||107.68|73.10|
73976058|NCT06140290|147497114|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|97.54|||||TWO_SIDED|90.0|78.74|120.83|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||120.83|78.74|
74031770|NCT00431847|147616790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3457|STANDARD_ERROR_OF_MEAN|3.2285||0.4682|TWO_SIDED|95.0|-8.7034|4.012|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.0120|-8.7034|0.4682
74031771|NCT00431847|147616791|SUPERIORITY_OR_OTHER||Slope|0.04639|STANDARD_ERROR_OF_MEAN|0.03562||0.1938|TWO_SIDED|95.0|-0.02369|0.1165|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.1165|-0.02369|0.1938
73945843|NCT03587142|147424328|SUPERIORITY||Mean Difference (Net)|0.17||||0.59|TWO_SIDED|95.0|-0.44|0.77||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.77|-0.44|0.59
73945844|NCT03587142|147424329|SUPERIORITY||Mean Difference (Net)|0.24||||0.46|TWO_SIDED|95.0|-0.39|0.88||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.88|-0.39|0.46
73945845|NCT03587142|147424330|SUPERIORITY||Mean Difference (Net)|0.09||||0.73|TWO_SIDED|95.0|-0.42|0.59||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.59|-0.42|0.73
73945846|NCT03587142|147424331|SUPERIORITY||Mean Difference (Net)|-0.14||||0.5|TWO_SIDED|95.0|-0.55|0.27||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.27|-0.55|0.50
73945847|NCT03587142|147424332|SUPERIORITY||Mean Difference (Net)|0.32||||0.18|TWO_SIDED|95.0|-0.15|0.79||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.79|-0.15|0.18
73945848|NCT03587142|147424333|SUPERIORITY||Mean Difference (Net)|1.01||||0.19|TWO_SIDED|95.0|-0.49|2.51||P value is nominal: no adjustments made from multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002.|ANCOVA|||Adjusted mean difference from differences (DoD) from the baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported; P value (2-sided) determined from a Wald Chi-Square test.||2.51|-0.49|0.19
73945849|NCT03587142|147424334|SUPERIORITY||Mean Difference (Net)|1.86||||0.02|TWO_SIDED|95.0|0.33|3.38||P value is nominal: no adjustments made for multiple comparisons. Bonferroni P-value threshold for the level of significance is \<=0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the HADS depression score.||3.38|0.33|0.02
73945850|NCT03587142|147424335|SUPERIORITY||Mean Difference (Net)|0.76||||0.4|TWO_SIDED|95.0|-1.02|2.54||P values are nominal; no adjustments for multiple comparisons|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the HADS anxiety total score. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test||2.54|-1.02|0.40
73945851|NCT03587142|147424336|SUPERIORITY||Mean Difference (Net)|-0.21||||0.25|TWO_SIDED|95.0|-0.57|0.15||P value is nominal with no adjustment for multiple comparisons. The Bonferroni level of significance threshold is \<=0.002.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of PAGI-QOL total score.||0.15|-0.57|0.25
73976059|NCT06140290|147497115|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|94.14|||||TWO_SIDED|90.0|79.01|112.17|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||112.17|79.01|
73976060|NCT06140290|147497115|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|103.36|||||TWO_SIDED|90.0|86.04|124.16|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||124.16|86.04|
73976061|NCT02722434|147497133|SUPERIORITY|||||||0.1228|||||||Chi-squared|||||||0.1228
73976062|NCT02722434|147497134|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
73945852|NCT03587142|147424337|SUPERIORITY||Mean Difference (Net)|-1.98||||0.36|TWO_SIDED|95.0|-6.2|2.24|||ANCOVA|||Adjusted mean difference of differences (DoD) of change in outcome from baseline and 95% Confidence Intervals were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of outcome. P (2-sided) were determined from a Wald-Chi-Square test.||2.24|-6.20|0.36
73945853|NCT03587142|147424338|SUPERIORITY||Mean Difference (Net)|-2.07||||0.15|TWO_SIDED|95.0|-4.91|0.76||P value is nominal; no adjustments made for multiple comparisons Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.76|-4.91|0.15
73945854|NCT03587142|147424339|SUPERIORITY||Mean Difference (Net)|1.37||||0.76|TWO_SIDED|95.0|-7.51|10.25||P value is nominal: no adjustments made for multiple comparisons. Bonferrini p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported. P (2-sided) determined from a Wald Chi-Square test.||10.25|-7.51|0.76
73976063|NCT02722434|147497135|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Sensory Subscale||||0.79
73976064|NCT02722434|147497135|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Motor Subscale||||0.43
73976065|NCT02722434|147497135|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Autonomic Subscale||||0.97
73976066|NCT02941549|147497162|SUPERIORITY||LS Mean Difference|-6.9||||0.5946|TWO_SIDED|95.0|-34.5|20.7|||ANCOVA|||||20.7|-34.5|0.5946
73976067|NCT02941549|147497162|SUPERIORITY||LS Mean Difference|-10.1||||0.7309|TWO_SIDED|95.0|-36.9|16.8|||ANCOVA|||||16.8|-36.9|0.7309
73976068|NCT02941549|147497163|SUPERIORITY||LS Mean Difference|-1.308||||0.0763|TWO_SIDED|95.0|-2.11|-0.51|||ANCOVA|||||-0.51|-2.11|0.0763
73976069|NCT02941549|147497163|SUPERIORITY||LS Mean Difference|-0.727||||0.0058|TWO_SIDED|95.0|-1.554|0.1|||ANCOVA|||||0.100|-1.554|0.0058
73976070|NCT03601715|147497180|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
73945855|NCT03587142|147424340|SUPERIORITY||Mean Difference (Net)|-0.05||||0.1|TWO_SIDED|95.0|-0.12|0.01||Nominal P values; no adjustment for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) were computed using ANCOVA, regressing change in IMD from baseline to 4-weeks on treatment group and the baseline value of IMD. Wald 95% Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||0.01|-0.12|0.10
73945856|NCT03587142|147424341|SUPERIORITY||Mean Difference (Net)|-21.51||||0.29|TWO_SIDED|95.0|-99.4|56.4||Nominal P values; no adjustments for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of teh outcome. Wald 95% Confidence Limits are reported; P (2-sided) determined from a Wald Chi-Square test.||56.4|-99.4|0.29
73945857|NCT03587142|147424342|SUPERIORITY||Mean Difference (Net)|0.09||||0.84|TWO_SIDED|95.0|-0.78|0.95||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to week 4 on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported: P (2-sided) determined from Wald Chi-Square test.||0.95|-0.78|0.84
73945858|NCT03587142|147424343|SUPERIORITY||Mean Difference (Net)|-6.43||||0.27|TWO_SIDED|95.0|-17.9|5.03||P value is nominal|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||5.03|-17.90|0.27
73945859|NCT03587142|147424344|SUPERIORITY||Mean Difference (Net)|-1.02||||0.74|TWO_SIDED|95.0|-6.93|4.89||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||4.89|-6.93|0.74
73945860|NCT03587142|147424345|SUPERIORITY||Mean Difference (Net)|0.03||||0.18|TWO_SIDED|95.0|-0.01|0.08|||ANCOVA|P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance \<0.002||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||0.08|-0.01|0.18
73945861|NCT03587142|147424346|SUPERIORITY||Mean Difference (Net)|-0.39||||0.97|TWO_SIDED|95.0|-20.42|19.64||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||19.64|-20.42|0.97
73945862|NCT03587142|147424347|SUPERIORITY||Incident rate ratio|1.27||||0.64|TWO_SIDED|95.0|0.57|2.82||P values are nominal and not adjusted for multiple comparisons.|Exact poisson regression|||Event rates are computed by treatment arm by dividing the total adverse events over 4-weeks by the number of patient-months of follow-up to 4-weeks. Event rates are compared by treatment arm using an exact poisson regression for event rates.||2.82|0.57|0.64
73945863|NCT03587142|147424348|SUPERIORITY||Incident rate ratio|0.95||||0.54|TWO_SIDED|95.0|0.35|2.62||P values are nominal.|Fisher Exact|||A Fisher's Exact test was used for comparisons of events by treatment by severity grade. One patient in the Buspirone arm had 2 AEs during the trial; for analysis by severity grade the maximum severity grade was used.|An exact poisson regression stratified by severity level was used to compute the incident rate ratio and 95% Confidence Intervals for adverse events by severity level.|2.62|0.35|0.54
73945864|NCT03587142|147424349|SUPERIORITY|||||||1||||||P value is nominal.|Fisher Exact|||||||1.00
74031772|NCT00431847|147616791|SUPERIORITY_OR_OTHER||Chi-Squared|2.43||||0.4884|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4884
73945865|NCT03587142|147424350|SUPERIORITY||Incident rate ratio|1.03||||1|TWO_SIDED|95.0|0.0|40.36||P-values are nominal.|Exact poisson regression|||Event rates were computed by dividing the number of hospitalizations over 4-weeks by the number of person-years. An exact poisson regression was used to compare events by treatment group.||40.36|0|1.00
73945866|NCT03587142|147424351|SUPERIORITY|||||||0.52||||||Nominal P value.|Binomial probability test|2-sided test with probability of success=0||||||0.52
73945867|NCT00708435|147424363|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in effective hemostasis (%)|7.1|||||TWO_SIDED|95.0|-5.8|19.9||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.|95% confidence interval|Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with hemostasis.|Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.|The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.||19.9|-5.8|
74039470|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.34||0.0121|TWO_SIDED|95.0|-1.5|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-1.50|0.0121
73869941|NCT03637517|147283545|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|-0.2857|STANDARD_ERROR_OF_MEAN|1.866979|||TWO_SIDED|90.0|-3.4313|2.8599||||||||2.8599|-3.4313|
73869942|NCT03637517|147283545|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|9.3571|STANDARD_ERROR_OF_MEAN|1.866979|||TWO_SIDED|90.0|6.2115|12.5028|||||Regimen C to B|||12.5028|6.2115|
74031773|NCT00431847|147616791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6174|STANDARD_ERROR_OF_MEAN|1.3991||0.6593|TWO_SIDED|95.0|-2.1348|3.3696|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.3696|-2.1348|0.6593
74031774|NCT00431847|147616791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4575|STANDARD_ERROR_OF_MEAN|2.0263||0.0889|TWO_SIDED|95.0|-0.528|7.4431|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.4431|-0.5280|0.0889
74039471|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.05|-0.71|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.71|-2.05|<.0001
73869943|NCT03637517|147283547|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.866||||0.1745|TWO_SIDED|90.0|0.727|1.032|||ANOVA|||(ANOVA) will be performed for Tmax, the terminal phase elimination rate constant β, and the natural logarithms of Cmax, AUCt, AUC168, AUCinf, and C168. The model will include the effects for regimen. For the tests on regimen effects, the denominator sum of squares will be the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen will be compared to the respective reference regimen by a test with a significance level of 0.05.||1.032|0.727|0.1745
73945868|NCT00708435|147424364|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in the decrease of INR (%)|52.6|||||TWO_SIDED|95.0|39.4|65.9||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.|95% confidence interval|Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with a rapid decrease of the INR.|Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.|The analysis of the percentage of participants who had a rapid decrease of the INR was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with a rapid decrease of the INR.||65.9|39.4|
73945869|NCT01737684|147424378|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.27|||||TWO_SIDED|90.0|0.96|1.67|||ANCOVA|||||1.67|0.96|
73945870|NCT01737684|147424381|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.35|||||TWO_SIDED|90.0|0.88|2.06|||ANCOVA|||||2.06|0.88|
73945871|NCT03502616|147424418|SUPERIORITY||Difference in percentage|27.08|STANDARD_ERROR_OF_MEAN|5.71|<|0.0001|TWO_SIDED|95.0|15.89|38.28|||Cochran-Mantel-Haenszel|||Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach.||38.28|15.89|<0.0001
73945872|NCT03502616|147424419|SUPERIORITY||Difference in percentage|28.17|STANDARD_ERROR_OF_MEAN|5.06|<|0.0001|TWO_SIDED|95.0|18.26|38.09|||Cochran-Mantel-Haenszel|||Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||38.09|18.26|<0.0001
73945873|NCT03502616|147424426|SUPERIORITY||Difference in percentage|18.28|STANDARD_ERROR_OF_MEAN|4.7||0.0001|TWO_SIDED|95.0|9.06|27.5|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||27.50|9.06|0.0001
73945874|NCT03502616|147424426|SUPERIORITY||Difference in percentage|31.35|STANDARD_ERROR_OF_MEAN|5.47|<|0.0001|TWO_SIDED|95.0|20.64|42.06|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.06|20.64|<0.0001
73945875|NCT03502616|147424426|SUPERIORITY||Difference in percentage|32.24|STANDARD_ERROR_OF_MEAN|5.57|<|0.0001|TWO_SIDED|95.0|21.32|43.17|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||43.17|21.32|<0.0001
73945876|NCT03502616|147424426|SUPERIORITY||Difference in percentage|34.61|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|23.63|45.58|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||45.58|23.63|<0.0001
73869944|NCT03637517|147283547|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.185||||0.1105|TWO_SIDED|90.0|0.995|1.411||For tests on regimen effects, the denominator sum of squares is the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen is compared to the respective reference regimen by a test with a significance level of 0.05.|ANOVA|||||1.411|0.995|0.1105
73945877|NCT03502616|147424426|SUPERIORITY||Difference in percentage|3.65|STANDARD_ERROR_OF_MEAN|5.9||0.536|TWO_SIDED|95.0|-7.92|15.22|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.22|-7.92|0.5360
73945878|NCT03502616|147424426|SUPERIORITY||Difference in percentage|3.83|STANDARD_ERROR_OF_MEAN|5.63||0.4971|TWO_SIDED|95.0|-7.22|14.87|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.87|-7.22|0.4971
73945879|NCT03502616|147424426|SUPERIORITY||Difference in percentage|1.58|STANDARD_ERROR_OF_MEAN|5.65||0.7792|TWO_SIDED|95.0|-9.49|12.66|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||12.66|-9.49|0.7792
73945880|NCT03502616|147424426|SUPERIORITY||Difference in percentage|5.22|STANDARD_ERROR_OF_MEAN|5.8||0.3685|TWO_SIDED|95.0|-6.15|16.58|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.58|-6.15|0.3685
73945881|NCT03502616|147424427|SUPERIORITY||Difference in percentage|6.12|STANDARD_ERROR_OF_MEAN|3.19||0.0548|TWO_SIDED|95.0|-0.13|12.37|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||12.37|-0.13|0.0548
73945882|NCT03502616|147424427|SUPERIORITY||Difference in percentage|23.43|STANDARD_ERROR_OF_MEAN|4.15|<|0.0001|TWO_SIDED|95.0|15.3|31.56|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.56|15.30|<0.0001
73945883|NCT03502616|147424427|SUPERIORITY||Difference in percentage|28.56|STANDARD_ERROR_OF_MEAN|4.54|<|0.0001|TWO_SIDED|95.0|19.66|37.47|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||37.47|19.66|<0.0001
73945884|NCT03502616|147424427|SUPERIORITY||Difference in percentage|31.18|STANDARD_ERROR_OF_MEAN|5.02|<|0.0001|TWO_SIDED|95.0|21.34|41.02|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||41.02|21.34|<0.0001
73945885|NCT03502616|147424427|SUPERIORITY||Difference in percentage|6.29|STANDARD_ERROR_OF_MEAN|5.98||0.2926|TWO_SIDED|95.0|-5.43|18.01|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.01|-5.43|0.2926
73945886|NCT03502616|147424427|SUPERIORITY||Difference in percentage|6.37|STANDARD_ERROR_OF_MEAN|5.97||0.2856|TWO_SIDED|95.0|-5.32|18.06|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.06|-5.32|0.2856
73945887|NCT03502616|147424427|SUPERIORITY||Difference in percentage|7.83|STANDARD_ERROR_OF_MEAN|5.97||0.1894|TWO_SIDED|95.0|-3.87|19.54|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach||19.54|-3.87|0.1894
73945888|NCT03502616|147424427|SUPERIORITY||Difference in percentage|5.59|STANDARD_ERROR_OF_MEAN|6.04||0.3544|TWO_SIDED|95.0|-6.24|17.43|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach||17.43|-6.24|0.3544
73945889|NCT03502616|147424428|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.85|-0.57|||Mixed Models Analysis|||Week 2: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.57|-0.85|<0.0001
73945890|NCT03502616|147424428|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-1.07|-0.74|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.74|-1.07|<0.0001
73945891|NCT03502616|147424428|SUPERIORITY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-1.25|-0.87|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.87|-1.25|<0.0001
73945892|NCT03502616|147424428|SUPERIORITY||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-1.28|-0.9|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.90|-1.28|<0.0001
73945893|NCT03502616|147424428|SUPERIORITY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|-1.16|-0.79|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.79|-1.16|<0.0001
74039472|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.3697|TWO_SIDED|95.0|-0.89|0.33|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.33|-0.89|0.3697
73869945|NCT03637517|147283548|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|0.901||||0.31|TWO_SIDED|90.0|0.759|1.069|||ANOVA|||||1.069|0.759|0.3100
73869946|NCT03637517|147283548|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|1.156||||0.1619|TWO_SIDED|90.0|0.974|1.371|||ANOVA|||||1.371|0.974|0.1619
73869947|NCT02714283|147283553|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.19|TWO_SIDED|95.0|0.51|1.14|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use.|ICS (numerator) compared to macrolide monotherapy (denominator)|Due to the small sample size in the macrolide monotherapy group, for this outcome, the results are considered exploratory/descriptive only.||1.14|0.51|0.19
73945894|NCT03502616|147424428|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.103||0.0623|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||Week 24: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.01|-0.40|0.0623
73945895|NCT03502616|147424428|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.106||0.0836|TWO_SIDED|95.0|-0.39|0.02|||Mixed Models Analysis|||Week 32: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.02|-0.39|0.0836
73945896|NCT03502616|147424428|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.108||0.0205|TWO_SIDED|95.0|-0.47|-0.04|||Mixed Models Analysis|||Week 40: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-0.47|0.0205
73945897|NCT03502616|147424428|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.108||0.0614|TWO_SIDED|95.0|-0.42|0.01|||Mixed Models Analysis|||Week 48: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.01|-0.42|0.0614
73976071|NCT03601715|147497181|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
73976072|NCT03601715|147497182|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
73976073|NCT00857766|147497210|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.42||||0.065||95.0|-0.88|0.03|||ANCOVA||LS mean difference is calculated as FSC 250/50 minus Placebo and is adjusted for treatment, investigator, sex, smoking status, age, body mass index (BMI), waist circumference, treatment by sex interaction, age by BMI interaction, and baseline value.|||0.03|-0.88|0.065
73976074|NCT00857766|147497211|SUPERIORITY_OR_OTHER||Least squares analysis|-0.6|STANDARD_ERROR_OF_MEAN|0.86||0.469||95.0|-2.3|1.1|||ANCOVA|||||1.1|-2.3|0.469
73976075|NCT00857766|147497212|SUPERIORITY_OR_OTHER||Least squares analysis|127.0|STANDARD_ERROR_OF_MEAN|35.5|<|0.001||95.0|57.0|197.0|||ANCOVA|||||197|57|<0.001
74031775|NCT00431847|147616791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4499|STANDARD_ERROR_OF_MEAN|2.8061||0.8727|TWO_SIDED|95.0|-5.9692|5.0694|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||5.0694|-5.9692|0.8727
73976076|NCT01536093|147497223|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
73976077|NCT01536093|147497224|SUPERIORITY_OR_OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.043
73976078|NCT01536093|147497225|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
73976079|NCT01536093|147497226|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||||||0.038
73976080|NCT01536093|147497227|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
73976081|NCT01536093|147497228|SUPERIORITY_OR_OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
73976082|NCT00918203|147497281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.2133|TWO_SIDED|95.0|0.86|1.93|||Log Rank|||||1.93|0.86|0.2133
73976083|NCT00918203|147497284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8731|TWO_SIDED|95.0|0.68|1.57|||Log Rank|||||1.57|0.68|0.8731
73976084|NCT00918203|147497285|SUPERIORITY_OR_OTHER|||||||0.4721|||||||Fisher Exact|||||||0.4721
73869948|NCT02714283|147283554|SUPERIORITY||Hazard Ratio (HR)|1.39|||<|0.0001|TWO_SIDED|95.0|1.23|1.57|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.57|1.23|<0.0001
73869949|NCT02714283|147283555|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.21|TWO_SIDED|95.0|0.67|1.09|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.09|0.67|0.21
73869950|NCT02714283|147283556|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.82|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||0.82|0.64|<0.0001
73945898|NCT03502616|147424429|SUPERIORITY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-1.15|-0.7|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.70|-1.15|<0.0001
73945899|NCT03502616|147424429|SUPERIORITY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.121|<|0.0001|TWO_SIDED|95.0|-1.16|-0.68|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.68|-1.16|<0.0001
73945900|NCT03502616|147424429|SUPERIORITY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|0.196|<|0.0001|TWO_SIDED|95.0|-1.4|-0.63|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.63|-1.40|<0.0001
73945901|NCT03502616|147424429|SUPERIORITY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001|TWO_SIDED|95.0|-1.19|-0.74|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.74|-1.19|<0.0001
73945902|NCT03502616|147424429|SUPERIORITY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-1.2|-0.72|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.72|-1.20|<0.0001
73945903|NCT03502616|147424429|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.073||0.4731|TWO_SIDED|95.0|-0.2|0.09|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.20|0.4731
73945904|NCT03502616|147424429|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.094||0.4055|TWO_SIDED|95.0|-0.26|0.11|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.11|-0.26|0.4055
73976085|NCT05485805|147497341|OTHER||Geometric LS means|-5.95|||=|0.004|TWO_SIDED|95.0|-9.946|-1.954|||ANCOVA|||||-1.954|-9.946|= 0.004
73869951|NCT02714283|147283557|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.87|TWO_SIDED|95.0|0.8|1.32|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.32|0.80|0.87
73945905|NCT03502616|147424429|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.111||0.2648|TWO_SIDED|95.0|-0.34|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.34|0.2648
73945906|NCT03502616|147424429|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.099||0.5558|TWO_SIDED|95.0|-0.25|0.14|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.14|-0.25|0.5558
73945907|NCT03502616|147424430|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.513||0.0001|TWO_SIDED|95.0|-3.03|-1.01|||ANCOVA|||Week 16: Analysis performed using Analysis of covariance (ANCOVA) model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-1.01|-3.03|0.0001
73945908|NCT03502616|147424430|SUPERIORITY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.567||0.027|TWO_SIDED|95.0|-2.38|-0.14|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.14|-2.38|0.0270
73976086|NCT05485805|147497341|OTHER||Geometric LS means|6.161|||=|0.003|TWO_SIDED|95.0|2.161|10.161|||ANCOVA|||||10.161|2.161|= 0.003
73976087|NCT05485805|147497341|OTHER||Geometric LS means|25.936|||<|0.001|TWO_SIDED|95.0|20.317|31.556|||ANCOVA|||||31.556|20.317|< 0.001
73976088|NCT05485805|147497341|OTHER||Geometric LS means|-3.476|||=|0.325|TWO_SIDED|95.0|-10.41|3.457|||ANCOVA|||||3.457|-10.41|= 0.325
73976089|NCT05485805|147497341|OTHER||Geometric LS means|0.211|||=|0.918|TWO_SIDED|95.0|-3.798|4.22|||ANCOVA|||||4.22|-3.798|= 0.918
73976090|NCT05485805|147497341|OTHER||Geometric LS means|32.097|||<|0.001|TWO_SIDED|95.0|26.484|37.71|||ANCOVA|||||37.71|26.484|< 0.001
73976091|NCT05485805|147497341|OTHER||Geometric LS means|22.46|||<|0.001|TWO_SIDED|95.0|16.753|28.166|||ANCOVA|||||28.166|16.753|< 0.001
73976092|NCT05485805|147497341|OTHER||Geometric LS means|26.147|||<|0.001|TWO_SIDED|95.0|20.529|31.765|||ANCOVA|||||31.765|20.529|< 0.001
73976093|NCT05485805|147497341|OTHER||Geometric LS means|28.62|||<|0.001|TWO_SIDED|95.0|22.921|34.32|||ANCOVA|||||34.32|22.921|< 0.001
73976094|NCT05485805|147497341|OTHER||Geometric LS means|22.671|||<|0.001|TWO_SIDED|95.0|16.966|28.375|||ANCOVA|||||28.375|16.966|< 0.001
73976095|NCT05485805|147497342|OTHER||Geometric LS means|-1.602|||<|0.001|TWO_SIDED|95.0|-2.548|-0.656|||ANCOVA|||0-2 hours post-dose||-0.656|-2.548|< 0.001
73869952|NCT02714283|147283558|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.23|TWO_SIDED|95.0|0.76|1.07|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.07|0.76|0.23
73869953|NCT02714283|147283559|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.2|TWO_SIDED|95.0|0.96|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.25|0.96|0.20
73945909|NCT03502616|147424431|SUPERIORITY||LS mean difference|2.22|STANDARD_ERROR_OF_MEAN|0.841||0.0088|TWO_SIDED|95.0|0.56|3.88|||ANCOVA|||Week 16, Physical Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.88|0.56|0.0088
73945910|NCT03502616|147424431|SUPERIORITY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|0.939||0.0016|TWO_SIDED|95.0|1.15|4.85|||ANCOVA|||Week 16, Role-Physical: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.85|1.15|0.0016
73945911|NCT03502616|147424431|SUPERIORITY||LS mean difference|4.46|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|2.69|6.23|||ANCOVA|||Week 16, Bodily Pain: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||6.23|2.69|<0.0001
73945912|NCT03502616|147424431|SUPERIORITY||LS mean difference|3.24|STANDARD_ERROR_OF_MEAN|0.781|<|0.0001|TWO_SIDED|95.0|1.7|4.78|||ANCOVA|||Week 16, General Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.78|1.70|<0.0001
73945913|NCT03502616|147424431|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.098||0.1065|TWO_SIDED|95.0|-0.38|3.94|||ANCOVA|||Week 16, Vitality: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.94|-0.38|0.1065
73945914|NCT03502616|147424431|SUPERIORITY||LS mean difference|2.96|STANDARD_ERROR_OF_MEAN|1.059||0.0055|TWO_SIDED|95.0|0.88|5.05|||ANCOVA|||Week 16, Social Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||5.05|0.88|0.0055
73945915|NCT03502616|147424431|SUPERIORITY||LS mean difference|2.08|STANDARD_ERROR_OF_MEAN|1.289||0.1084|TWO_SIDED|95.0|-0.46|4.61|||ANCOVA|||Week 16, Role-Emotional: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.61|-0.46|0.1084
73945916|NCT03502616|147424431|SUPERIORITY||LS mean difference|1.08|STANDARD_ERROR_OF_MEAN|1.124||0.3379|TWO_SIDED|95.0|-1.13|3.29|||ANCOVA|||Week 16, Mental Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.29|-1.13|0.3379
73945917|NCT03502616|147424431|SUPERIORITY||LS mean difference|3.55|STANDARD_ERROR_OF_MEAN|0.744|<|0.0001|TWO_SIDED|95.0|2.09|5.02|||ANCOVA|||Week 16, Physical Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||5.02|2.09|<0.0001
73945918|NCT03502616|147424431|SUPERIORITY||LS mean difference|1.33|STANDARD_ERROR_OF_MEAN|1.158||0.2529|TWO_SIDED|95.0|-0.95|3.61|||ANCOVA|||Week 16, Mental Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.61|-0.95|0.2529
73945919|NCT03502616|147424431|SUPERIORITY||LS mean difference|0.86|STANDARD_ERROR_OF_MEAN|0.964||0.3744|TWO_SIDED|95.0|-1.04|2.76|||Mixed Models Analysis|||Week 48, Physical Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.76|-1.04|0.3744
73945920|NCT03502616|147424431|SUPERIORITY||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|1.083||0.2091|TWO_SIDED|95.0|-0.77|3.5|||Mixed Models Analysis|||Week 48, Role-Physical: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.50|-0.77|0.2091
73945921|NCT03502616|147424431|SUPERIORITY||LS mean difference|2.12|STANDARD_ERROR_OF_MEAN|1.146||0.0654|TWO_SIDED|95.0|-0.14|4.38|||Mixed Models Analysis|||Week 48, Bodily Pain: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.38|-0.14|0.0654
73945922|NCT03502616|147424431|SUPERIORITY||LS mean difference|1.22|STANDARD_ERROR_OF_MEAN|0.968||0.21|TWO_SIDED|95.0|-0.69|3.12|||Mixed Models Analysis|||Week 48, General Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.12|-0.69|0.2100
74031776|NCT00431847|147616792|SUPERIORITY_OR_OTHER||Slope|-0.523|STANDARD_ERROR_OF_MEAN|0.08855|<|0.0001|TWO_SIDED|95.0|-0.6973|-0.3486|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.3486|-0.6973|<.0001
73945923|NCT03502616|147424431|SUPERIORITY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|1.248||0.6568|TWO_SIDED|95.0|-1.9|3.01|||Mixed Models Analysis|||Week 48, Vitality: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.01|-1.90|0.6568
73945924|NCT03502616|147424431|SUPERIORITY||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|1.152||0.2288|TWO_SIDED|95.0|-0.88|3.66|||Mixed Models Analysis|||Week 48, Social Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.66|-0.88|0.2288
73945925|NCT03502616|147424431|SUPERIORITY||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|1.25||0.4955|TWO_SIDED|95.0|-1.61|3.32|||Mixed Models Analysis|||Week 48, Role-Emotional: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.32|-1.61|0.4955
73945926|NCT03502616|147424431|SUPERIORITY||LS mean difference|0.65|STANDARD_ERROR_OF_MEAN|1.2||0.5888|TWO_SIDED|95.0|-1.71|3.01|||Mixed Models Analysis|||Week 48, Mental Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.01|-1.71|0.5888
73945927|NCT03502616|147424431|SUPERIORITY||LS mean difference|1.42|STANDARD_ERROR_OF_MEAN|0.896||0.115|TWO_SIDED|95.0|-0.35|3.18|||Mixed Models Analysis|||Week 48, Physical Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.18|-0.35|0.1150
73976096|NCT05485805|147497342|OTHER||Geometric LS means|0.976|||=|0.043|TWO_SIDED|95.0|0.029|1.923|||ANCOVA|||0-2 hours post-dose||1.923|0.029|= 0.043
73976097|NCT05485805|147497342|OTHER||Geometric LS means|6.097|||<|0.001|TWO_SIDED|95.0|4.766|7.427|||ANCOVA|||0-2 hours post-dose||7.427|4.766|< 0.001
73976098|NCT05485805|147497342|OTHER||Geometric LS means|0.31|||=|0.711|TWO_SIDED|95.0|-1.332|1.951|||ANCOVA|||0-2 hours post-dose||1.951|-1.332|= 0.711
73945928|NCT03502616|147424431|SUPERIORITY||LS mean difference|0.72|STANDARD_ERROR_OF_MEAN|1.158||0.5347|TWO_SIDED|95.0|-1.56|3.0|||Mixed Models Analysis|||Week 48, Mental Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.00|-1.56|0.5347
73945929|NCT03502616|147424432|SUPERIORITY||LS mean difference|1.29|STANDARD_ERROR_OF_MEAN|0.898||0.1513|TWO_SIDED|95.0|-0.48|3.06|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.06|-0.48|0.1513
73976099|NCT05485805|147497342|OTHER||Geometric LS means|-0.626|||=|0.196|TWO_SIDED|95.0|-1.575|0.323|||ANCOVA|||0-2 hours post-dose||0.323|-1.575|= 0.196
73976100|NCT05485805|147497342|OTHER||Geometric LS means|7.073|||<|0.001|TWO_SIDED|95.0|5.744|8.402|||ANCOVA|||0-2 hours post-dose||8.402|5.744|< 0.001
73976101|NCT05485805|147497342|OTHER||Geometric LS means|6.406|||<|0.001|TWO_SIDED|95.0|5.055|7.757|||ANCOVA|||0-2 hours post-dose||7.757|5.055|< 0.001
73976102|NCT05485805|147497342|OTHER||Geometric LS means|5.471|||<|0.001|TWO_SIDED|95.0|4.141|6.801|||ANCOVA|||0-2 hours post-dose||6.801|4.141|< 0.001
73976103|NCT05485805|147497342|OTHER||Geometric LS means|7.383|||<|0.001|TWO_SIDED|95.0|6.033|8.732|||ANCOVA|||0-2 hours post-dose||8.732|6.033|< 0.001
74031777|NCT00431847|147616792|SUPERIORITY_OR_OTHER||Chi-Squared|4.89||||0.18|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.1800
73869954|NCT02714283|147283560|SUPERIORITY||Hazard Ratio (HR)|1.15|||<|0.0001|TWO_SIDED|95.0|1.08|1.21|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.21|1.08|<0.0001
73976104|NCT05485805|147497342|OTHER||Geometric LS means|5.78|||<|0.001|TWO_SIDED|95.0|4.43|7.131|||ANCOVA|||0-2 hours post-dose||7.131|4.43|< 0.001
73976105|NCT05485805|147497343|OTHER||Geometric LS means|-0.586|||<|0.001|TWO_SIDED|95.0|-0.903|-0.269|||ANCOVA|||0-2 hours post-dose||-0.269|-0.903|< 0.001
74031778|NCT00431847|147616792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.302|STANDARD_ERROR_OF_MEAN|2.8198||0.4151|TWO_SIDED|95.0|-3.253|7.857|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.8570|-3.2530|0.4151
73976106|NCT05485805|147497343|OTHER||Geometric LS means|0.454|||=|0.005|TWO_SIDED|95.0|0.136|0.771|||ANCOVA|||0-2 hours post-dose||0.771|0.136|= 0.005
73976107|NCT05485805|147497343|OTHER||Geometric LS means|2.369|||<|0.001|TWO_SIDED|95.0|1.923|2.815|||ANCOVA|||0-2 hours post-dose||2.815|1.923|< 0.001
73976108|NCT05485805|147497343|OTHER||Geometric LS means|-0.169|||=|0.548|TWO_SIDED|95.0|-0.719|0.382|||ANCOVA|||0-2 hours post-dose||0.382|-0.719|= 0.548
73976109|NCT05485805|147497343|OTHER||Geometric LS means|-0.132|||=|0.415|TWO_SIDED|95.0|-0.451|0.186|||ANCOVA|||0-2 hours post-dose||0.186|-0.451|= 0.415
73976110|NCT05485805|147497343|OTHER||Geometric LS means|2.823|||<|0.001|TWO_SIDED|95.0|2.377|3.268|||ANCOVA|||0-2 hours post-dose||3.268|2.377|< 0.001
73976111|NCT05485805|147497343|OTHER||Geometric LS means|2.201|||<|0.001|TWO_SIDED|95.0|1.748|2.654|||ANCOVA|||0-2 hours post-dose||2.654|1.748|< 0.001
73976112|NCT05485805|147497343|OTHER||Geometric LS means|2.237|||<|0.001|TWO_SIDED|95.0|1.791|2.683|||ANCOVA|||0-2 hours post-dose||2.683|1.791|< 0.001
73976113|NCT05485805|147497343|OTHER||Geometric LS means|2.654|||<|0.001|TWO_SIDED|95.0|2.202|3.106|||ANCOVA|||0-2 hours post-dose||3.106|2.202|< 0.001
73976114|NCT05485805|147497343|OTHER||Geometric LS means|2.068|||<|0.001|TWO_SIDED|95.0|1.615|2.521|||ANCOVA|||0-2 hours post-dose||2.521|1.615|< 0.001
73976115|NCT05485805|147497343|OTHER||Geometric LS means|-1.338|||<|0.001|TWO_SIDED|95.0|-2.133|-0.542|||ANCOVA|||0-4 hours post-dose||-0.542|-2.133|< 0.001
73976116|NCT05485805|147497343|OTHER||Geometric LS means|1.016|||=|0.012|TWO_SIDED|95.0|0.22|1.813|||ANCOVA|||0-4 hours post-dose||1.813|0.22|= 0.012
73976117|NCT05485805|147497343|OTHER||Geometric LS means|5.982|||<|0.001|TWO_SIDED|95.0|4.864|7.101|||ANCOVA|||0-4 hours post-dose||7.101|4.864|< 0.001
73976118|NCT05485805|147497343|OTHER||Geometric LS means|-1.048|||=|0.136|TWO_SIDED|95.0|-2.428|0.332|||ANCOVA|||0-4 hours post-dose||0.332|-2.428|= 0.136
73976119|NCT05485805|147497343|OTHER||Geometric LS means|-0.321|||=|0.43|TWO_SIDED|95.0|-1.119|0.477|||ANCOVA|||0-4 hours post-dose||0.477|-1.119|= 0.43
73976120|NCT05485805|147497343|OTHER||Geometric LS means|6.999|||<|0.001|TWO_SIDED|95.0|5.881|8.116|||ANCOVA|||0-4 hours post-dose||8.116|5.881|< 0.001
73945930|NCT03502616|147424432|SUPERIORITY||LS mean difference|1.56|STANDARD_ERROR_OF_MEAN|1.02||0.1279|TWO_SIDED|95.0|-0.45|3.56|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.56|-0.45|0.1279
73945931|NCT03502616|147424432|SUPERIORITY||LS mean difference|3.83|STANDARD_ERROR_OF_MEAN|1.056||0.0003|TWO_SIDED|95.0|1.75|5.9|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.90|1.75|0.0003
73945932|NCT03502616|147424432|SUPERIORITY||LS mean difference|3.32|STANDARD_ERROR_OF_MEAN|1.282||0.0102|TWO_SIDED|95.0|0.79|5.84|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.84|0.79|0.0102
73945933|NCT03502616|147424432|SUPERIORITY||LS mean difference|4.73|STANDARD_ERROR_OF_MEAN|1.285||0.0003|TWO_SIDED|95.0|2.2|7.26|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.26|2.20|0.0003
73945934|NCT03502616|147424432|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|1.439||0.895|TWO_SIDED|95.0|-2.64|3.02|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.02|-2.64|0.8950
73945935|NCT03502616|147424432|SUPERIORITY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|1.365||0.4732|TWO_SIDED|95.0|-3.67|1.71|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.71|-3.67|0.4732
73945936|NCT03502616|147424432|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.523||0.6359|TWO_SIDED|95.0|-3.72|2.28|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.28|-3.72|0.6359
73945937|NCT03502616|147424432|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.495||0.6894|TWO_SIDED|95.0|-3.54|2.35|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.35|-3.54|0.6894
73945938|NCT03502616|147424433|SUPERIORITY||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|0.94||0.141|TWO_SIDED|95.0|-0.46|3.24|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.24|-0.46|0.1410
73945939|NCT03502616|147424433|SUPERIORITY||LS mean difference|2.78|STANDARD_ERROR_OF_MEAN|1.102||0.0122|TWO_SIDED|95.0|0.61|4.95|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.95|0.61|0.0122
73945940|NCT03502616|147424433|SUPERIORITY||LS mean difference|3.32|STANDARD_ERROR_OF_MEAN|1.252||0.0085|TWO_SIDED|95.0|0.86|5.79|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.79|0.86|0.0085
73945941|NCT03502616|147424433|SUPERIORITY||LS mean difference|3.36|STANDARD_ERROR_OF_MEAN|1.416||0.0184|TWO_SIDED|95.0|0.57|6.15|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.15|0.57|0.0184
73976121|NCT05485805|147497343|OTHER||Geometric LS means|4.934|||<|0.001|TWO_SIDED|95.0|3.798|6.07|||ANCOVA|||0-4 hours post-dose||6.07|3.798|< 0.001
73976122|NCT05485805|147497343|OTHER||Geometric LS means|5.661|||<|0.001|TWO_SIDED|95.0|4.543|6.779|||ANCOVA|||0-4 hours post-dose||6.779|4.543|< 0.001
73976123|NCT05485805|147497343|OTHER||Geometric LS means|5.951|||<|0.001|TWO_SIDED|95.0|4.816|7.085|||ANCOVA|||0-4 hours post-dose||7.085|4.816|< 0.001
73976124|NCT05485805|147497343|OTHER||Geometric LS means|4.613|||<|0.001|TWO_SIDED|95.0|3.478|5.749|||ANCOVA|||0-4 hours post-dose||5.749|3.478|< 0.001
73976125|NCT05485805|147497343|OTHER||Geometric LS means|-1.963|||=|0.003|TWO_SIDED|95.0|-3.254|-0.673|||ANCOVA|||0-6 hours post-dose||-0.673|-3.254|= 0.003
73976126|NCT05485805|147497343|OTHER||Geometric LS means|1.641|||=|0.013|TWO_SIDED|95.0|0.35|2.933|||ANCOVA|||0-6 hours post-dose||2.933|0.35|= 0.013
73976127|NCT05485805|147497343|OTHER||Geometric LS means|9.191|||<|0.001|TWO_SIDED|95.0|7.377|11.006|||ANCOVA|||0-6 hours post-dose||11.006|7.377|< 0.001
73976128|NCT05485805|147497343|OTHER||Geometric LS means|-1.642|||=|0.15|TWO_SIDED|95.0|-3.881|0.597|||ANCOVA|||0-6 hours post-dose||0.597|-3.881|= 0.15
73976129|NCT05485805|147497343|OTHER||Geometric LS means|-0.322|||=|0.625|TWO_SIDED|95.0|-1.617|0.972|||ANCOVA|||0-6 hours post-dose||0.972|-1.617|= 0.625
73976130|NCT05485805|147497343|OTHER||Geometric LS means|10.833|||<|0.001|TWO_SIDED|95.0|9.02|12.645|||ANCOVA|||0-6 hours post-dose||12.645|9.02|< 0.001
73976131|NCT05485805|147497343|OTHER||Geometric LS means|7.55|||<|0.001|TWO_SIDED|95.0|5.707|9.392|||ANCOVA|||0-6 hours post-dose||9.392|5.707|< 0.001
73945942|NCT03502616|147424433|SUPERIORITY||LS mean difference|4.19|STANDARD_ERROR_OF_MEAN|1.38||0.0026|TWO_SIDED|95.0|1.47|6.91|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.91|1.47|0.0026
73945943|NCT03502616|147424433|SUPERIORITY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|1.495||0.0236|TWO_SIDED|95.0|0.46|6.35|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.35|0.46|0.0236
73945944|NCT03502616|147424433|SUPERIORITY||LS mean difference|3.66|STANDARD_ERROR_OF_MEAN|1.541||0.0182|TWO_SIDED|95.0|0.63|6.7|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.70|0.63|0.0182
73945945|NCT03502616|147424433|SUPERIORITY||LS mean difference|3.85|STANDARD_ERROR_OF_MEAN|1.545||0.0133|TWO_SIDED|95.0|0.81|6.9|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.90|0.81|0.0133
73945946|NCT03502616|147424433|SUPERIORITY||LS mean difference|3.49|STANDARD_ERROR_OF_MEAN|1.541||0.0245|TWO_SIDED|95.0|0.45|6.52|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.52|0.45|0.0245
73945947|NCT03502616|147424434|SUPERIORITY||LS mean difference|0.81|STANDARD_ERROR_OF_MEAN|0.257||0.0018|TWO_SIDED|95.0|0.3|1.32|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.32|0.30|0.0018
73945948|NCT03502616|147424434|SUPERIORITY||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|0.301||0.0005|TWO_SIDED|95.0|0.47|1.65|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.65|0.47|0.0005
73945949|NCT03502616|147424434|SUPERIORITY||LS mean difference|1.19|STANDARD_ERROR_OF_MEAN|0.305||0.0001|TWO_SIDED|95.0|0.59|1.79|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.79|0.59|0.0001
73945950|NCT03502616|147424434|SUPERIORITY||LS mean difference|1.63|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|1.09|2.17|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.17|1.09|<0.0001
73976132|NCT05485805|147497343|OTHER||Geometric LS means|8.869|||<|0.001|TWO_SIDED|95.0|7.055|10.683|||ANCOVA|||0-6 hours post-dose||10.683|7.055|< 0.001
73945951|NCT03502616|147424434|SUPERIORITY||LS mean difference|1.87|STANDARD_ERROR_OF_MEAN|0.344|<|0.0001|TWO_SIDED|95.0|1.2|2.55|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.55|1.20|<0.0001
73945952|NCT03502616|147424434|SUPERIORITY||LS mean difference|0.95|STANDARD_ERROR_OF_MEAN|0.353||0.0075|TWO_SIDED|95.0|0.26|1.65|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.65|0.26|0.0075
73945953|NCT03502616|147424434|SUPERIORITY||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|0.403||0.1489|TWO_SIDED|95.0|-0.21|1.38|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.38|-0.21|0.1489
73945954|NCT03502616|147424434|SUPERIORITY||LS mean difference|0.78|STANDARD_ERROR_OF_MEAN|0.417||0.0609|TWO_SIDED|95.0|-0.04|1.61|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.61|-0.04|0.0609
73976133|NCT05485805|147497343|OTHER||Geometric LS means|9.191|||<|0.001|TWO_SIDED|95.0|7.351|11.031|||ANCOVA|||0-6 hours post-dose||11.031|7.351|< 0.001
73976134|NCT05485805|147497343|OTHER||Geometric LS means|7.228|||<|0.001|TWO_SIDED|95.0|5.386|9.07|||ANCOVA|||0-6 hours post-dose||9.07|5.386|< 0.001
73976135|NCT05485805|147497343|OTHER||Geometric LS means|-2.398|||=|0.009|TWO_SIDED|95.0|-4.185|-0.61|||ANCOVA|||0-8 hours post-dose||-0.61|-4.185|= 0.009
73976136|NCT05485805|147497343|OTHER||Geometric LS means|2.4|||=|0.009|TWO_SIDED|95.0|0.61|4.189|||ANCOVA|||0-8 hours post-dose||4.189|0.61|= 0.009
73976137|NCT05485805|147497343|OTHER||Geometric LS means|11.898|||<|0.001|TWO_SIDED|95.0|9.384|14.412|||ANCOVA|||0-8 hours post-dose||14.412|9.384|< 0.001
73976138|NCT05485805|147497343|OTHER||Geometric LS means|-2.225|||=|0.159|TWO_SIDED|95.0|-5.327|0.877|||ANCOVA|||0-8 hours post-dose||0.877|-5.327|= 0.159
73976139|NCT05485805|147497343|OTHER||Geometric LS means|0.002|||=|0.998|TWO_SIDED|95.0|-1.792|1.795|||ANCOVA|||0-8 hours post-dose||1.795|-1.792|= 0.998
73976140|NCT05485805|147497343|OTHER||Geometric LS means|14.298|||<|0.001|TWO_SIDED|95.0|11.787|16.809|||ANCOVA|||0-8 hours post-dose||16.809|11.787|< 0.001
73945955|NCT03502616|147424434|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.429||0.4822|TWO_SIDED|95.0|-0.54|1.15|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.15|-0.54|0.4822
73945956|NCT03502616|147424435|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.131||0.0047|TWO_SIDED|95.0|0.12|0.63|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.63|0.12|0.0047
73945957|NCT03502616|147424435|SUPERIORITY||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.131||0.0001|TWO_SIDED|95.0|0.26|0.77|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.77|0.26|0.0001
73945958|NCT03502616|147424435|SUPERIORITY||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.148||0.0012|TWO_SIDED|95.0|0.19|0.78|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.78|0.19|0.0012
73945959|NCT03502616|147424435|SUPERIORITY||LS mean difference|0.48|STANDARD_ERROR_OF_MEAN|0.142||0.0008|TWO_SIDED|95.0|0.2|0.76|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.76|0.20|0.0008
73945960|NCT03502616|147424435|SUPERIORITY||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.147||0.0004|TWO_SIDED|95.0|0.24|0.81|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.81|0.24|0.0004
73945961|NCT03502616|147424435|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.188||0.0918|TWO_SIDED|95.0|-0.05|0.69|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.69|-0.05|0.0918
73945962|NCT03502616|147424435|SUPERIORITY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.179||0.16|TWO_SIDED|95.0|-0.1|0.61|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.61|-0.10|0.1600
73945963|NCT03502616|147424435|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.195||0.6776|TWO_SIDED|95.0|-0.3|0.47|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.47|-0.30|0.6776
73945964|NCT03502616|147424435|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5646|TWO_SIDED|95.0|-0.25|0.46|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.46|-0.25|0.5646
73945965|NCT03502616|147424436|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.161||0.7291|TWO_SIDED|95.0|-0.26|0.37|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.37|-0.26|0.7291
73976141|NCT05485805|147497343|OTHER||Geometric LS means|9.673|||<|0.001|TWO_SIDED|95.0|7.12|12.226|||ANCOVA|||0-8 hours post-dose||12.226|7.12|< 0.001
73945966|NCT03502616|147424436|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.184||0.0257|TWO_SIDED|95.0|-0.78|-0.05|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.05|-0.78|0.0257
73976142|NCT05485805|147497343|OTHER||Geometric LS means|11.9|||<|0.001|TWO_SIDED|95.0|9.387|14.413|||ANCOVA|||0-8 hours post-dose||14.413|9.387|< 0.001
73976143|NCT05485805|147497343|OTHER||Geometric LS means|12.073|||<|0.001|TWO_SIDED|95.0|9.523|14.623|||ANCOVA|||0-8 hours post-dose||14.623|9.523|< 0.001
73976144|NCT05485805|147497343|OTHER||Geometric LS means|9.675|||<|0.001|TWO_SIDED|95.0|7.123|12.227|||ANCOVA|||0-8 hours post-dose||12.227|7.123|< 0.001
73976145|NCT05485805|147497343|OTHER||Geometric LS means|-2.949|||=|0.043|TWO_SIDED|95.0|-5.803|-0.095|||ANCOVA|||0-12 hours post-dose||-0.095|-5.803|= 0.043
73976146|NCT05485805|147497343|OTHER||Geometric LS means|3.694|||=|0.011|TWO_SIDED|95.0|0.837|6.55|||ANCOVA|||0-12 hours post-dose||6.55|0.837|= 0.011
73976147|NCT05485805|147497343|OTHER||Geometric LS means|16.504|||<|0.001|TWO_SIDED|95.0|12.49|20.517|||ANCOVA|||0-12 hours post-dose||20.517|12.49|< 0.001
73976148|NCT05485805|147497343|OTHER||Geometric LS means|-3.437|||=|0.173|TWO_SIDED|95.0|-8.389|1.515|||ANCOVA|||0-12 hours post-dose||1.515|-8.389|= 0.173
73976149|NCT05485805|147497343|OTHER||Geometric LS means|0.744|||=|0.61|TWO_SIDED|95.0|-2.119|3.608|||ANCOVA|||0-12 hours post-dose||3.608|-2.119|= 0.61
73976150|NCT05485805|147497343|OTHER||Geometric LS means|20.197|||<|0.001|TWO_SIDED|95.0|16.189|24.206|||ANCOVA|||0-12 hours post-dose||24.206|16.189|< 0.001
73869955|NCT02714283|147283561|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.66|1.51|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.51|0.66|0.99
73945967|NCT03502616|147424436|SUPERIORITY||LS mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.227||0.0002|TWO_SIDED|95.0|-1.31|-0.42|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.42|-1.31|0.0002
73945968|NCT03502616|147424436|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.216||0.0041|TWO_SIDED|95.0|-1.05|-0.2|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-1.05|0.0041
73945969|NCT03502616|147424436|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.215||0.0062|TWO_SIDED|95.0|-1.02|-0.17|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.17|-1.02|0.0062
73945970|NCT03502616|147424436|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.255||0.014|TWO_SIDED|95.0|-1.13|-0.13|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.13|-1.13|0.0140
73945971|NCT03502616|147424436|SUPERIORITY||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.225||0.0035|TWO_SIDED|95.0|-1.11|-0.22|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.22|-1.11|0.0035
73945972|NCT03502616|147424436|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.253||0.0645|TWO_SIDED|95.0|-0.97|0.03|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-0.97|0.0645
73945973|NCT03502616|147424436|SUPERIORITY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.255||0.0341|TWO_SIDED|95.0|-1.05|-0.04|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-1.05|0.0341
73945974|NCT03502616|147424437|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.056||0.0001|TWO_SIDED|95.0|-0.33|-0.11|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.11|-0.33|0.0001
73945975|NCT03502616|147424437|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001|TWO_SIDED|95.0|-0.47|-0.2|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-0.47|<0.0001
73976151|NCT05485805|147497343|OTHER||Geometric LS means|13.067|||<|0.001|TWO_SIDED|95.0|8.992|17.143|||ANCOVA|||0-12 hours post-dose||17.143|8.992|< 0.001
73976152|NCT05485805|147497343|OTHER||Geometric LS means|17.248|||<|0.001|TWO_SIDED|95.0|13.236|21.261|||ANCOVA|||0-12 hours post-dose||21.261|13.236|< 0.001
73976153|NCT05485805|147497343|OTHER||Geometric LS means|16.761|||<|0.001|TWO_SIDED|95.0|12.69|20.831|||ANCOVA|||0-12 hours post-dose||20.831|12.69|< 0.001
73976154|NCT05485805|147497343|OTHER||Geometric LS means|13.812|||<|0.001|TWO_SIDED|95.0|9.738|17.886|||ANCOVA|||0-12 hours post-dose||17.886|9.738|< 0.001
73976155|NCT05485805|147497343|OTHER||Geometric LS means|-2.312|||=|0.473|TWO_SIDED|95.0|-8.635|4.011|||ANCOVA|||0-24 hours post-dose||4.011|-8.635|= 0.473
73976156|NCT05485805|147497343|OTHER||Geometric LS means|27.08|||<|0.001|TWO_SIDED|95.0|18.188|35.973|||ANCOVA|||0-24 hours post-dose||35.973|18.188|< 0.001
73976157|NCT05485805|147497343|OTHER||Geometric LS means|-6.928|||=|0.215|TWO_SIDED|95.0|-17.9|4.044|||ANCOVA|||0-24 hours post-dose||4.044|-17.9|= 0.215
73976158|NCT05485805|147497343|OTHER||Geometric LS means|2.468|||=|0.445|TWO_SIDED|95.0|-3.876|8.813|||ANCOVA|||0-24 hours post-dose||8.813|-3.876|= 0.445
73976159|NCT05485805|147497343|OTHER||Geometric LS means|20.152|||<|0.001|TWO_SIDED|95.0|11.122|29.183|||ANCOVA|||0-24 hours post-dose||29.183|11.122|< 0.001
73976160|NCT05485805|147497343|OTHER||Geometric LS means|24.933|||<|0.001|TWO_SIDED|95.0|15.914|33.952|||ANCOVA|||0-24 hours post-dose||33.952|15.914|< 0.001
73976161|NCT05485805|147497343|OTHER||Geometric LS means|22.621|||<|0.001|TWO_SIDED|95.0|13.594|31.648|||ANCOVA|||0-24 hours post-dose||31.648|13.594|< 0.001
73976162|NCT05485805|147497344|OTHER||||||=|0.963|||||||ANCOVA|||||||= 0.963
73869956|NCT02714283|147283562|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.0005|TWO_SIDED|95.0|1.07|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.25|1.07|0.0005
73976163|NCT05485805|147497344|OTHER||||||=|0.118|||||||ANCOVA|||||||= 0.118
73976164|NCT05485805|147497344|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976165|NCT05485805|147497344|OTHER||||||=|0.244|||||||ANCOVA|||||||= 0.244
73976166|NCT05485805|147497344|OTHER||||||=|0.139|||||||ANCOVA|||||||= 0.139
73976167|NCT05485805|147497344|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976168|NCT05485805|147497344|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976169|NCT05485805|147497344|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976170|NCT05485805|147497344|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976171|NCT05485805|147497344|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976172|NCT05485805|147497346|OTHER||||||=|0.647|||||||ANCOVA|||||||= 0.647
73945976|NCT03502616|147424437|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.61|-0.31|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.31|-0.61|<0.0001
73945977|NCT03502616|147424437|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.62|-0.32|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.32|-0.62|<0.0001
73945978|NCT03502616|147424437|SUPERIORITY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.077|<|0.0001|TWO_SIDED|95.0|-0.67|-0.37|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.37|-0.67|<0.0001
73945979|NCT03502616|147424437|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.086||0.0008|TWO_SIDED|95.0|-0.46|-0.12|||LS mean difference|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.12|-0.46|0.0008
73945980|NCT03502616|147424437|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.086||0.0116|TWO_SIDED|95.0|-0.39|-0.05|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.05|-0.39|0.0116
73945981|NCT03502616|147424437|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.093||0.0416|TWO_SIDED|95.0|-0.37|-0.01|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.01|-0.37|0.0416
73945982|NCT03502616|147424437|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.092||0.0915|TWO_SIDED|95.0|-0.34|0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-0.34|0.0915
73945983|NCT03502616|147424438|SUPERIORITY||LS mean difference|2.85|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|1.46|4.24|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.24|1.46|<0.0001
73945984|NCT03502616|147424438|SUPERIORITY||LS mean difference|3.61|STANDARD_ERROR_OF_MEAN|0.761|<|0.0001|TWO_SIDED|95.0|2.11|5.1|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.10|2.11|<0.0001
73945985|NCT03502616|147424438|SUPERIORITY||LS mean difference|5.42|STANDARD_ERROR_OF_MEAN|0.902|<|0.0001|TWO_SIDED|95.0|3.65|7.2|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.20|3.65|<0.0001
73945986|NCT03502616|147424438|SUPERIORITY||LS mean difference|5.01|STANDARD_ERROR_OF_MEAN|0.943|<|0.0001|TWO_SIDED|95.0|3.15|6.86|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.86|3.15|<0.0001
73945987|NCT03502616|147424438|SUPERIORITY||LS mean difference|3.43|STANDARD_ERROR_OF_MEAN|1.012||0.0008|TWO_SIDED|95.0|1.44|5.42|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.42|1.44|0.0008
73976173|NCT05485805|147497346|OTHER||||||=|0.714|||||||ANCOVA|||||||= 0.714
73976174|NCT05485805|147497346|OTHER||||||=|0.065|||||||ANCOVA|||||||= 0.065
74031779|NCT00431847|147616792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3376|STANDARD_ERROR_OF_MEAN|4.314||0.3157|TWO_SIDED|95.0|-4.1592|12.8344|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||12.8344|-4.1592|0.3157
73976175|NCT05485805|147497346|OTHER||||||=|0.742|||||||ANCOVA|||||||= 0.742
73976176|NCT05485805|147497346|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976177|NCT05485805|147497346|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976178|NCT05485805|147497346|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976179|NCT05485805|147497346|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976180|NCT05485805|147497346|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976181|NCT05485805|147497347|OTHER||||||=|0.162|||||||ANCOVA|||||||= 0.162
73976182|NCT05485805|147497347|OTHER||||||=|0.319|||||||ANCOVA|||||||= 0.319
73976183|NCT05485805|147497347|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976184|NCT05485805|147497347|OTHER||||||=|0.343|||||||ANCOVA|||||||= 0.343
73976185|NCT05485805|147497347|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976186|NCT05485805|147497347|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976187|NCT05485805|147497347|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976188|NCT05485805|147497347|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73869957|NCT00620113|147283563|SUPERIORITY_OR_OTHER||Difference in LS Means|5.4|||<|0.001|TWO_SIDED|95.0|4.16|6.64||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an analysis of covariance (ANCOVA) model with terms for treatment and study center. Treatment effect was assessed by Least-Squares means (LS mean) and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.64|4.16|<0.001
73869958|NCT00620113|147283563|SUPERIORITY_OR_OTHER||Difference in LS Means|5.12|||<|0.001|TWO_SIDED|95.0|3.9|6.35||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.35|3.90|<0.001
73945988|NCT03502616|147424438|SUPERIORITY||LS mean difference|1.58|STANDARD_ERROR_OF_MEAN|1.064||0.139|TWO_SIDED|95.0|-0.52|3.68|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.68|-0.52|0.1390
73945989|NCT03502616|147424438|SUPERIORITY||LS mean difference|0.66|STANDARD_ERROR_OF_MEAN|1.024||0.5217|TWO_SIDED|95.0|-1.36|2.67|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.67|-1.36|0.5217
73945990|NCT03502616|147424438|SUPERIORITY||LS mean difference|1.51|STANDARD_ERROR_OF_MEAN|1.027||0.1415|TWO_SIDED|95.0|-0.51|3.54|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.54|-0.51|0.1415
73945991|NCT03502616|147424438|SUPERIORITY||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|1.128||0.0533|TWO_SIDED|95.0|-0.03|4.41|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.41|-0.03|0.0533
73976189|NCT05485805|147497347|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976190|NCT05485805|147497348|OTHER||||||=|0.162|||||||ANCOVA|||||||= 0.162
73976191|NCT05485805|147497348|OTHER||||||=|0.319|||||||ANCOVA|||||||= 0.319
73976192|NCT05485805|147497348|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976193|NCT05485805|147497348|OTHER||||||=|0.343|||||||ANCOVA|||||||= 0.343
74031780|NCT00431847|147616792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.825|STANDARD_ERROR_OF_MEAN|6.9715||0.0911|TWO_SIDED|95.0|-1.904|25.5541|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||25.5541|-1.9040|0.0911
73976194|NCT05485805|147497348|OTHER||||||=|0.772|||||||ANCOVA|||||||= 0.772
73976195|NCT05485805|147497348|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976196|NCT05485805|147497348|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976197|NCT05485805|147497348|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976198|NCT05485805|147497348|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976199|NCT05485805|147497348|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73976200|NCT05485805|147497351|OTHER||geometric LS mean square|-0.14|||=|0.334|TWO_SIDED|95.0|-0.44|0.15|||ANCOVA|||||0.15|-0.44|= 0.334
73976201|NCT05485805|147497351|OTHER||geometric LS mean square|0.04|||=|0.783|TWO_SIDED|95.0|-0.25|0.33|||ANCOVA|||||0.33|-0.25|= 0.783
73976202|NCT05485805|147497351|OTHER||geometric LS mean square|-0.08|||=|0.687|TWO_SIDED|95.0|-0.5|0.33|||ANCOVA|||||0.33|-0.5|= 0.687
73976203|NCT05485805|147497351|OTHER||geometric LS mean square|-0.02|||=|0.927|TWO_SIDED|95.0|-0.53|0.49|||ANCOVA|||||0.49|-0.53|= 0.927
73976204|NCT05485805|147497351|OTHER||geometric LS mean square|-0.1|||=|0.492|TWO_SIDED|95.0|-0.4|0.19|||ANCOVA|||||0.19|-0.4|= 0.492
73976205|NCT05485805|147497351|OTHER||geometric LS mean square|-0.04|||=|0.836|TWO_SIDED|95.0|-0.46|0.37|||ANCOVA|||||0.37|-0.46|= 0.836
73976206|NCT05485805|147497351|OTHER||geometric LS mean square|-0.11|||=|0.611|TWO_SIDED|95.0|-0.53|0.31|||ANCOVA|||||0.31|-0.53|= 0.611
73976207|NCT05485805|147497351|OTHER||geometric LS mean square|-0.19|||=|0.371|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||||0.22|-0.6|= 0.371
73976208|NCT05485805|147497351|OTHER||geometric LS mean square|-0.07|||=|0.752|TWO_SIDED|95.0|-0.49|0.35|||ANCOVA|||||0.35|-0.49|= 0.752
73976209|NCT05485805|147497351|OTHER||geometric LS mean square|-0.21|||=|0.321|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||||0.21|-0.63|= 0.321
73976210|NCT04640974|147497357|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
73976211|NCT04640974|147497358|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
73976212|NCT04640974|147497359|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
73976213|NCT05886777|147497382|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 4, respectively.|Geometric mean ratio|0.99|||||TWO_SIDED|97.5|0.782|1.249|||||GMRs and 2-sided confidence intervals (CIs) were calculated by exponentiating mean differences of logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).|||1.249|0.782|
74031781|NCT00431847|147616793|SUPERIORITY_OR_OTHER||Slope|-0.2888|STANDARD_ERROR_OF_MEAN|0.09078||0.0016|TWO_SIDED|95.0|-0.4675|-0.11|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1100|-0.4675|0.0016
74031782|NCT00431847|147616793|SUPERIORITY_OR_OTHER||Chi-Squared|6.33||||0.0966|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.0966
74031783|NCT00431847|147616793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9879|STANDARD_ERROR_OF_MEAN|2.4264||0.2195|TWO_SIDED|95.0|-1.7938|7.7697|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.7697|-1.7938|0.2195
74031784|NCT00431847|147616793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4636|STANDARD_ERROR_OF_MEAN|3.7381||0.5105|TWO_SIDED|95.0|-9.8289|4.9018|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.9018|-9.8289|0.5105
74031785|NCT00431847|147616793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3871|STANDARD_ERROR_OF_MEAN|6.1087||0.0903|TWO_SIDED|95.0|-22.4174|1.6433|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.6433|-22.4174|0.0903
73945992|NCT03502616|147424439|SUPERIORITY||LS mean difference|1.25|STANDARD_ERROR_OF_MEAN|0.352||0.0005|TWO_SIDED|95.0|0.55|1.94|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.94|0.55|0.0005
73945993|NCT03502616|147424439|SUPERIORITY||LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|0.95|2.45|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.45|0.95|<0.0001
73945994|NCT03502616|147424439|SUPERIORITY||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|0.423|<|0.0001|TWO_SIDED|95.0|1.35|3.02|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.02|1.35|<0.0001
74031786|NCT00431847|147616794|SUPERIORITY_OR_OTHER||Slope|-0.04113|STANDARD_ERROR_OF_MEAN|-0.04113||0.6602|TWO_SIDED|95.0|-0.2252|0.1429|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.1429|-0.2252|0.6602
73869959|NCT00620113|147283563|SUPERIORITY_OR_OTHER||Difference in LS Means|3.54|||<|0.001|TWO_SIDED|95.0|2.33|4.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||4.75|2.33|<0.001
73945995|NCT03502616|147424439|SUPERIORITY||LS mean difference|1.98|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|1.11|2.84|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.84|1.11|<0.0001
73945996|NCT03502616|147424439|SUPERIORITY||LS mean difference|1.56|STANDARD_ERROR_OF_MEAN|0.454||0.0007|TWO_SIDED|95.0|0.67|2.45|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.45|0.67|0.0007
73945997|NCT03502616|147424439|SUPERIORITY||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.485||0.2018|TWO_SIDED|95.0|-0.33|1.58|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.58|-0.33|0.2018
74031787|NCT00431847|147616794|SUPERIORITY_OR_OTHER||Chi-Squared|1.53||||0.6764|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6764
73976214|NCT05886777|147497383|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 4, respectively.|Geometric mean ratio|0.9|||||TWO_SIDED|97.5|0.697|1.162|||||GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).|||1.162|0.697|
73976215|NCT05886777|147497384|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.605|1.168|||||GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and corresponding CIs (based on the Student t distribution).|||1.168|0.605|
73976216|NCT05886777|147497385|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 3, respectively.|Geometric mean ratio|0.79|||||TWO_SIDED|97.5|0.618|1.014|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.014|0.618|
73976217|NCT05886777|147497386|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.06|||||TWO_SIDED|97.5|0.785|1.423|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.423|0.785|
73945998|NCT03502616|147424439|SUPERIORITY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.465||0.6432|TWO_SIDED|95.0|-0.7|1.13|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.13|-0.70|0.6432
73945999|NCT03502616|147424439|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.47||0.4092|TWO_SIDED|95.0|-0.54|1.31|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.31|-0.54|0.4092
73946000|NCT03502616|147424439|SUPERIORITY||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.506||0.107|TWO_SIDED|95.0|-0.18|1.81|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.81|-0.18|0.1070
73946001|NCT03502616|147424440|SUPERIORITY||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|0.428||0.0002|TWO_SIDED|95.0|0.78|2.46|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.46|0.78|0.0002
73946002|NCT03502616|147424440|SUPERIORITY||LS mean difference|1.92|STANDARD_ERROR_OF_MEAN|0.466|<|0.0001|TWO_SIDED|95.0|1.0|2.84|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.84|1.00|<0.0001
73976218|NCT05886777|147497387|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.13|||||TWO_SIDED|97.5|0.909|1.402|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.402|0.909|
73976219|NCT05886777|147497388|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.05|||||TWO_SIDED|97.5|0.773|1.434|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.434|0.773|
73946003|NCT03502616|147424440|SUPERIORITY||LS mean difference|3.26|STANDARD_ERROR_OF_MEAN|0.549|<|0.0001|TWO_SIDED|95.0|2.18|4.34|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.34|2.18|<0.0001
73946004|NCT03502616|147424440|SUPERIORITY||LS mean difference|3.04|STANDARD_ERROR_OF_MEAN|0.564|<|0.0001|TWO_SIDED|95.0|1.93|4.15|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.15|1.93|<0.0001
73946005|NCT03502616|147424440|SUPERIORITY||LS mean difference|1.87|STANDARD_ERROR_OF_MEAN|0.621||0.0028|TWO_SIDED|95.0|0.65|3.09|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.09|0.65|0.0028
73946006|NCT03502616|147424440|SUPERIORITY||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|0.638||0.1289|TWO_SIDED|95.0|-0.28|2.23|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.23|-0.28|0.1289
73946007|NCT03502616|147424440|SUPERIORITY||LS mean difference|0.45|STANDARD_ERROR_OF_MEAN|0.616||0.4698|TWO_SIDED|95.0|-0.77|1.66|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.66|-0.77|0.4698
73946008|NCT03502616|147424440|SUPERIORITY||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.603||0.0616|TWO_SIDED|95.0|-0.06|2.32|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.32|-0.06|0.0616
73946009|NCT03502616|147424440|SUPERIORITY||LS mean difference|1.37|STANDARD_ERROR_OF_MEAN|0.681||0.0455|TWO_SIDED|95.0|0.03|2.71|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.71|0.03|0.0455
73946010|NCT03502616|147424441|SUPERIORITY||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.185|<|0.0001|TWO_SIDED|95.0|-1.25|-0.52|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.52|-1.25|<0.0001
73946011|NCT03502616|147424441|SUPERIORITY||LS mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.215|<|0.0001|TWO_SIDED|95.0|-1.65|-0.8|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.80|-1.65|<0.0001
73946012|NCT03502616|147424441|SUPERIORITY||LS mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.232|<|0.0001|TWO_SIDED|95.0|-2.17|-1.26|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.26|-2.17|<0.0001
73946013|NCT03502616|147424441|SUPERIORITY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.247|<|0.0001|TWO_SIDED|95.0|-2.2|-1.23|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.23|-2.20|<0.0001
73946014|NCT03502616|147424441|SUPERIORITY||LS mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.07|-1.05|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.05|-2.07|<0.0001
73946015|NCT03502616|147424441|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.281||0.0483|TWO_SIDED|95.0|-1.11|0.0|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-1.11|0.0483
73946016|NCT03502616|147424441|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.286||0.0357|TWO_SIDED|95.0|-1.17|-0.04|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-1.17|0.0357
73946017|NCT03502616|147424441|SUPERIORITY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.278||0.0508|TWO_SIDED|95.0|-1.09|0.0|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.00|-1.09|0.0508
73946018|NCT03502616|147424441|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.282||0.0614|TWO_SIDED|95.0|-1.08|0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-1.08|0.0614
73946019|NCT03502616|147424442|SUPERIORITY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.186|<|0.0001|TWO_SIDED|95.0|-1.26|-0.53|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.53|-1.26|<0.0001
74031788|NCT00431847|147616794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4902|STANDARD_ERROR_OF_MEAN|2.6357||0.3458|TWO_SIDED|95.0|-2.7036|7.684|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.6840|-2.7036|0.3458
73946020|NCT03502616|147424442|SUPERIORITY||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.75|-0.92|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.92|-1.75|<0.0001
73946021|NCT03502616|147424442|SUPERIORITY||LS mean difference|-1.98|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-2.41|-1.54|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.54|-2.41|<0.0001
73946022|NCT03502616|147424442|SUPERIORITY||LS mean difference|-1.89|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|-2.37|-1.4|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.40|-2.37|<0.0001
73946023|NCT03502616|147424442|SUPERIORITY||LS mean difference|-1.62|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-2.1|-1.14|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.14|-2.10|<0.0001
73946024|NCT03502616|147424442|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.261||0.0492|TWO_SIDED|95.0|-1.03|0.0|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-1.03|0.0492
73946025|NCT03502616|147424442|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.266||0.2614|TWO_SIDED|95.0|-0.82|0.22|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.22|-0.82|0.2614
73946026|NCT03502616|147424442|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.272||0.0722|TWO_SIDED|95.0|-1.03|0.04|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.04|-1.03|0.0722
73946027|NCT03502616|147424442|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.275||0.0121|TWO_SIDED|95.0|-1.24|-0.15|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.15|-1.24|0.0121
73946028|NCT03502616|147424443|SUPERIORITY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.207|<|0.0001|TWO_SIDED|95.0|-1.33|-0.51|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.51|-1.33|<0.0001
73946029|NCT03502616|147424443|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.216|<|0.0001|TWO_SIDED|95.0|-2.02|-1.17|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.17|-2.02|<0.0001
73946030|NCT03502616|147424443|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-2.5|-1.54|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.54|-2.50|<0.0001
73946031|NCT03502616|147424443|SUPERIORITY||LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|-2.5|-1.5|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.50|-2.50|<0.0001
73946032|NCT03502616|147424443|SUPERIORITY||LS mean difference|-1.84|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.35|-1.32|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.32|-2.35|<0.0001
73946033|NCT03502616|147424443|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.274||0.0785|TWO_SIDED|95.0|-1.02|0.06|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.06|-1.02|0.0785
73946034|NCT03502616|147424443|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.275||0.3047|TWO_SIDED|95.0|-0.82|0.26|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.26|-0.82|0.3047
73976220|NCT05886777|147497389|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.11|||||TWO_SIDED|97.5|0.807|1.515|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.515|0.807|
73976221|NCT05886777|147497390|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A, RSV B as measured by NT:H0: ln(μ2)- ln(μ4) \<=ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 2, 4, respectively.|Geometric mean ratio|1.0|||||TWO_SIDED|97.5|0.769|1.288|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.288|0.769|
73976222|NCT05886777|147497391|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A, RSV B as measured by NT:H0: ln(μ2)- ln(μ4) \<=ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 2, 4, respectively.|Geometric mean ratio|1.09|||||TWO_SIDED|97.5|0.836|1.429|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.429|0.836|
73976223|NCT05886777|147497392|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 2,3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.594|1.19|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.190|0.594|
73946035|NCT03502616|147424443|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.283||0.1009|TWO_SIDED|95.0|-1.02|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-1.02|0.1009
73976224|NCT05886777|147497393|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 2,3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.632|1.125|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.125|0.632|
73976225|NCT05886777|147497394|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 4, respectively.|Geometric mean ratio|1.42|||||TWO_SIDED|97.5|1.123|1.801|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.801|1.123|
73976226|NCT05886777|147497395|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 4, respectively.|Geometric mean ratio|1.27|||||TWO_SIDED|97.5|0.977|1.651|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.651|0.977|
73976227|NCT05886777|147497396|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 7,3, respectively.|Geometric mean ratio|0.86|||||TWO_SIDED|97.5|0.61|1.208|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.208|0.610|
73976228|NCT05886777|147497397|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 3, respectively.|Geometric mean ratio|1.01|||||TWO_SIDED|97.5|0.764|1.34|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.340|0.764|
74039473|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.3||0.0658|TWO_SIDED|95.0|-1.16|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-1.16|0.0658
73869960|NCT00620113|147283564|SUPERIORITY_OR_OTHER||Difference in LS Means|3.06|||<|0.001|TWO_SIDED|95.0|2.14|3.98||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.98|2.14|<0.001
73869961|NCT00620113|147283564|SUPERIORITY_OR_OTHER||Difference in LS Means|2.2|||<|0.001|TWO_SIDED|95.0|1.29|3.12||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.12|1.29|<0.001
73869962|NCT00620113|147283564|SUPERIORITY_OR_OTHER||Difference in LS Means|1.67|||<|0.001|TWO_SIDED|95.0|0.77|2.57||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||2.57|0.77|<0.001
73869963|NCT00620113|147283567|SUPERIORITY_OR_OTHER||Difference in LS Means|3.08|||<|0.001|TWO_SIDED|95.0|1.85|4.31||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||4.31|1.85|<0.001
73869964|NCT00620113|147283567|SUPERIORITY_OR_OTHER||Difference in LS Means|1.86||||0.003|TWO_SIDED|95.0|0.64|3.08||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.08|0.64|0.003
73946036|NCT03502616|147424443|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.287||0.0764|TWO_SIDED|95.0|-1.08|0.05|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.05|-1.08|0.0764
73946037|NCT03502616|147424444|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.159||0.0089|TWO_SIDED|95.0|-0.73|-0.11|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.11|-0.73|0.0089
73946038|NCT03502616|147424444|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.179|<|0.0001|TWO_SIDED|95.0|-1.12|-0.42|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.42|-1.12|<0.0001
73946039|NCT03502616|147424444|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.202|<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.70|-1.50|<0.0001
73869965|NCT00620113|147283567|SUPERIORITY_OR_OTHER||Difference in LS Means|2.23|||<|0.001|TWO_SIDED|95.0|1.03|3.43||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.43|1.03|<0.001
73946040|NCT03502616|147424444|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.71|-0.88|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.88|-1.71|<0.0001
73946041|NCT03502616|147424444|SUPERIORITY||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|-1.66|-0.8|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.80|-1.66|<0.0001
73976229|NCT05886777|147497398|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|2.49|||||TWO_SIDED|97.5|1.914|3.232|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||3.232|1.914|
73976230|NCT05886777|147497399|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|1.3|||||TWO_SIDED|97.5|1.049|1.612|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.612|1.049|
73976231|NCT05886777|147497400|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|1.58|||||TWO_SIDED|97.5|1.155|2.165|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||2.165|1.155|
74031789|NCT00431847|147616794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2518|STANDARD_ERROR_OF_MEAN|4.0583||0.1969|TWO_SIDED|95.0|-13.2466|2.743|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.7430|-13.2466|0.1969
74031790|NCT00431847|147616794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.9796|STANDARD_ERROR_OF_MEAN|6.5287||0.048|TWO_SIDED|95.0|-25.8429|-0.1162|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-0.1162|-25.8429|0.0480
74031791|NCT00431847|147616795|SUPERIORITY_OR_OTHER||Slope|-0.2349|STANDARD_ERROR_OF_MEAN|0.1003||0.0199|TWO_SIDED|95.0|-0.4323|-0.03745|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.03745|-0.4323|0.0199
74031792|NCT00431847|147616795|SUPERIORITY_OR_OTHER||Chi-Squared|2.6||||0.4577|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4577
73946042|NCT03502616|147424444|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.242||0.1686|TWO_SIDED|95.0|-0.81|0.14|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.14|-0.81|0.1686
73946043|NCT03502616|147424444|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.238||0.28|TWO_SIDED|95.0|-0.72|0.21|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.21|-0.72|0.2800
73946044|NCT03502616|147424444|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.243||0.1135|TWO_SIDED|95.0|-0.86|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.86|0.1135
73946045|NCT03502616|147424444|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.247||0.2496|TWO_SIDED|95.0|-0.77|0.2|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.20|-0.77|0.2496
73946046|NCT03502616|147424445|SUPERIORITY||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-1.22|-0.47|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.47|-1.22|<0.0001
74031793|NCT00431847|147616795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9502|STANDARD_ERROR_OF_MEAN|2.8797||0.7417|TWO_SIDED|95.0|-6.624|4.7236|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.7236|-6.6240|0.7417
73869966|NCT00620113|147283568|SUPERIORITY_OR_OTHER||Difference in LS Means|4.66|||<|0.001|TWO_SIDED|95.0|3.18|6.14||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.14|3.18|<0.001
73869967|NCT00620113|147283568|SUPERIORITY_OR_OTHER||Difference in LS Means|3.84|||<|0.001|TWO_SIDED|95.0|2.37|5.3||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||5.30|2.37|<0.001
73869968|NCT00620113|147283568|SUPERIORITY_OR_OTHER||Difference in LS Means|2.43||||0.002|TWO_SIDED|95.0|0.99|3.88||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.88|0.99|0.002
73946047|NCT03502616|147424445|SUPERIORITY||LS mean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.89|-1.07|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.07|-1.89|<0.0001
73946048|NCT03502616|147424445|SUPERIORITY||LS mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.228|<|0.0001|TWO_SIDED|95.0|-2.06|-1.16|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.16|-2.06|<0.0001
73946049|NCT03502616|147424445|SUPERIORITY||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.237|<|0.0001|TWO_SIDED|95.0|-2.34|-1.4|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.40|-2.34|<0.0001
73946050|NCT03502616|147424445|SUPERIORITY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.236|<|0.0001|TWO_SIDED|95.0|-2.18|-1.25|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.25|-2.18|<0.0001
73946051|NCT03502616|147424445|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.245||0.0385|TWO_SIDED|95.0|-0.99|-0.03|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-0.99|0.0385
73946052|NCT03502616|147424445|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.252||0.0463|TWO_SIDED|95.0|-1.0|-0.01|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.01|-1.00|0.0463
73946053|NCT03502616|147424445|SUPERIORITY||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.257||0.0126|TWO_SIDED|95.0|-1.15|-0.14|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.14|-1.15|0.0126
73946054|NCT03502616|147424445|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.268||0.0372|TWO_SIDED|95.0|-1.09|-0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-1.09|0.0372
73946055|NCT03502616|147424446|SUPERIORITY||Difference in percentage|13.6|STANDARD_ERROR_OF_MEAN|3.53||0.0001|TWO_SIDED|95.0|6.68|20.52|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||20.52|6.68|0.0001
73946056|NCT03502616|147424446|SUPERIORITY||Difference in percentage|28.79|STANDARD_ERROR_OF_MEAN|4.6|<|0.0001|TWO_SIDED|95.0|19.78|37.8|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||37.80|19.78|<0.0001
73869969|NCT00620113|147283569|SUPERIORITY_OR_OTHER||Difference in LS Means|-50.64|||<|0.001|TWO_SIDED|95.0|-66.43|-34.84||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-34.84|-66.43|<0.001
73869970|NCT00620113|147283569|SUPERIORITY_OR_OTHER||Difference in LS Means|-44.32|||<|0.001|TWO_SIDED|95.0|-60.42|-28.21||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-28.21|-60.42|<0.001
73869971|NCT00620113|147283569|SUPERIORITY_OR_OTHER||Difference in LS Means|-35.75|||<|0.001|TWO_SIDED|95.0|-52.33|-19.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-19.16|-52.33|<0.001
73869972|NCT00620113|147283570|SUPERIORITY_OR_OTHER||Difference in LS Means|-60.42|||<|0.001|TWO_SIDED|95.0|-85.7|-35.13||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-35.13|-85.70|<0.001
73869973|NCT00620113|147283570|SUPERIORITY_OR_OTHER||Difference in LS Means|-60.7|||<|0.001|TWO_SIDED|95.0|-85.91|-35.49||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-35.49|-85.91|<0.001
73869974|NCT00620113|147283570|SUPERIORITY_OR_OTHER||Difference in LS Means|-38.73|||<|0.001|TWO_SIDED|95.0|-65.94|-11.52||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-11.52|-65.94|<0.001
73869975|NCT00620113|147283571|SUPERIORITY_OR_OTHER||Difference in LS Means|-42.91|||<|0.001|TWO_SIDED|95.0|-65.55|-20.27||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-20.27|-65.55|<0.001
73946057|NCT03502616|147424446|SUPERIORITY||Difference in percentage|33.31|STANDARD_ERROR_OF_MEAN|4.83|<|0.0001|TWO_SIDED|95.0|23.84|42.78|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.78|23.84|<0.0001
74031794|NCT00431847|147616795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.258|STANDARD_ERROR_OF_MEAN|4.4523||0.7778|TWO_SIDED|95.0|-7.5129|10.0289|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||10.0289|-7.5129|0.7778
74031795|NCT00431847|147616795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5232|STANDARD_ERROR_OF_MEAN|7.2532||0.2411|TWO_SIDED|95.0|-5.7608|22.8073|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||22.8073|-5.7608|0.2411
73946058|NCT03502616|147424446|SUPERIORITY||Difference in percentage|36.37|STANDARD_ERROR_OF_MEAN|4.95|<|0.0001|TWO_SIDED|95.0|26.67|46.07|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||46.07|26.67|<0.0001
73946059|NCT03502616|147424446|SUPERIORITY||Difference in percentage|36.34|STANDARD_ERROR_OF_MEAN|4.74|<|0.0001|TWO_SIDED|95.0|27.05|45.63|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||45.63|27.05|<0.0001
73946060|NCT03502616|147424446|SUPERIORITY||Difference in percentage|5.6|STANDARD_ERROR_OF_MEAN|5.99||0.3498|TWO_SIDED|95.0|-6.14|17.35|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.35|-6.14|0.3498
73946061|NCT03502616|147424446|SUPERIORITY||Difference in percentage|-2.4|STANDARD_ERROR_OF_MEAN|5.89||0.6835|TWO_SIDED|95.0|-13.96|9.15|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.15|-13.96|0.6835
73946062|NCT03502616|147424446|SUPERIORITY||Difference in percentage|-1.75|STANDARD_ERROR_OF_MEAN|5.98||0.7704|TWO_SIDED|95.0|-13.47|9.98|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.98|-13.47|0.7704
73946063|NCT03502616|147424446|SUPERIORITY||Difference in percentage|-1.13|STANDARD_ERROR_OF_MEAN|5.95||0.8492|TWO_SIDED|95.0|-12.8|10.53|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||10.53|-12.80|0.8492
73946064|NCT03502616|147424447|SUPERIORITY||Difference in percentage|2.24|STANDARD_ERROR_OF_MEAN|1.63||0.1692|TWO_SIDED|95.0|-0.95|5.43|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||5.43|-0.95|0.1692
73946065|NCT03502616|147424447|SUPERIORITY||Difference in percentage|4.46|STANDARD_ERROR_OF_MEAN|2.04||0.0289|TWO_SIDED|95.0|0.46|8.46|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||8.46|0.46|0.0289
74031796|NCT00431847|147616796|SUPERIORITY_OR_OTHER||Slope|0.1629|STANDARD_ERROR_OF_MEAN|0.08284||0.0504|TWO_SIDED|95.0|-0.00029|0.3261|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.3261|-0.00029|0.0504
74031797|NCT00431847|147616796|SUPERIORITY_OR_OTHER||Chi-Squared|1.45||||0.6942|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6942
74031798|NCT00431847|147616796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5241|STANDARD_ERROR_OF_MEAN|2.4216||0.5297|TWO_SIDED|95.0|-3.2469|6.2951|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||6.2951|-3.2469|0.5297
74031799|NCT00431847|147616796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7679|STANDARD_ERROR_OF_MEAN|3.7464||0.3155|TWO_SIDED|95.0|-11.1478|3.612|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.6120|-11.1478|0.3155
74031800|NCT00431847|147616796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.7558|STANDARD_ERROR_OF_MEAN|6.092||0.1105|TWO_SIDED|95.0|-21.7515|2.2399|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.2399|-21.7515|0.1105
74031801|NCT00431847|147616797|SUPERIORITY_OR_OTHER||Slope|-0.2979|STANDARD_ERROR_OF_MEAN|0.07538||0.001|TWO_SIDED|95.0|-0.4465|-0.1493|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1493|-0.4465|0.001
73946066|NCT03502616|147424447|SUPERIORITY||Difference in percentage|6.02|STANDARD_ERROR_OF_MEAN|2.59||0.0199|TWO_SIDED|95.0|0.95|11.09|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||11.09|0.95|0.0199
73946067|NCT03502616|147424447|SUPERIORITY||Difference in percentage|12.03|STANDARD_ERROR_OF_MEAN|3.46||0.0005|TWO_SIDED|95.0|5.26|18.81|||Difference in percentage|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.81|5.26|0.0005
73946068|NCT03502616|147424447|SUPERIORITY||Difference in percentage|12.05|STANDARD_ERROR_OF_MEAN|3.45||0.0005|TWO_SIDED|95.0|5.29|18.8|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.80|5.29|0.0005
73946069|NCT03502616|147424447|SUPERIORITY||Difference in percentage|10.03|STANDARD_ERROR_OF_MEAN|4.49||0.0253|TWO_SIDED|95.0|1.24|18.83|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.83|1.24|0.0253
73946070|NCT03502616|147424447|SUPERIORITY||Difference in percentage|7.93|STANDARD_ERROR_OF_MEAN|4.75||0.095|TWO_SIDED|95.0|-1.38|17.24|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.24|-1.38|0.0950
74031802|NCT00431847|147616797|SUPERIORITY_OR_OTHER||Chi-Squared|2.72||||0.4361|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4361
73946071|NCT03502616|147424447|SUPERIORITY||Difference in percentage|7.21|STANDARD_ERROR_OF_MEAN|4.86||0.1377|TWO_SIDED|95.0|-2.31|16.73|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.73|-2.31|0.1377
73946072|NCT03502616|147424447|SUPERIORITY||Difference in percentage|5.68|STANDARD_ERROR_OF_MEAN|4.91||0.2472|TWO_SIDED|95.0|-3.94|15.3|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.30|-3.94|0.2472
73946073|NCT03502616|147424448|SUPERIORITY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.163|<|0.0001|TWO_SIDED|95.0|-1.05|-0.41|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.41|-1.05|<0.0001
73946074|NCT03502616|147424448|SUPERIORITY||LS mean difference|-1.28|STANDARD_ERROR_OF_MEAN|0.187|<|0.0001|TWO_SIDED|95.0|-1.65|-0.91|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.91|-1.65|<0.0001
73946075|NCT03502616|147424448|SUPERIORITY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.92|-1.09|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.09|-1.92|<0.0001
73946076|NCT03502616|147424448|SUPERIORITY||LS mean difference|-1.68|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-2.11|-1.24|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.24|-2.11|<0.0001
73976232|NCT05886777|147497401|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|3.49|||||TWO_SIDED|97.5|2.64|4.604|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||4.604|2.640|
74031803|NCT00431847|147616797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9001|STANDARD_ERROR_OF_MEAN|2.6015||0.7297|TWO_SIDED|95.0|-6.0247|4.2246|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.2246|-6.0247|0.7297
74039474|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.31||0.0004|TWO_SIDED|95.0|-1.7|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.50|-1.70|0.0004
73946077|NCT03502616|147424448|SUPERIORITY||LS mean difference|-1.44|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.88|-1.0|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.00|-1.88|<0.0001
73946078|NCT03502616|147424448|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.235||0.088|TWO_SIDED|95.0|-0.86|0.06|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.06|-0.86|0.0880
73946079|NCT03502616|147424448|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.241||0.0921|TWO_SIDED|95.0|-0.88|0.07|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.07|-0.88|0.0921
73946080|NCT03502616|147424448|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.243||0.0597|TWO_SIDED|95.0|-0.94|0.02|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.02|-0.94|0.0597
74031804|NCT00431847|147616797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.2896|STANDARD_ERROR_OF_MEAN|4.0186||0.2868|TWO_SIDED|95.0|-3.625|12.2043|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||12.2043|-3.6250|0.2868
74031805|NCT00431847|147616797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.0118|STANDARD_ERROR_OF_MEAN|6.2663||0.1516|TWO_SIDED|95.0|-3.327|21.3505|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||21.3505|-3.3270|0.1516
74031806|NCT00431847|147616798|SUPERIORITY_OR_OTHER||Slope|-0.9776|STANDARD_ERROR_OF_MEAN|0.1426|<|0.0001|TWO_SIDED|95.0|-1.2584|-0.6967|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury. T||-0.6967|-1.2584|<0.0001
74031807|NCT00431847|147616798|SUPERIORITY_OR_OTHER||Chi-Squared|0.78||||0.8548|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.8548
74031808|NCT00431847|147616798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3635|STANDARD_ERROR_OF_MEAN|3.8899||0.3882|TWO_SIDED|95.0|-4.3026|11.0296|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||11.0296|-4.3026|0.3882
74031809|NCT00431847|147616798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5029|STANDARD_ERROR_OF_MEAN|5.9044||0.9322|TWO_SIDED|95.0|-12.1376|11.1317|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||11.1317|-12.1376|0.9322
74031810|NCT00431847|147616798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.1166|STANDARD_ERROR_OF_MEAN|9.2462||0.0233|TWO_SIDED|95.0|2.8992|39.3341|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||39.3341|2.8992|0.0233
73946081|NCT03502616|147424448|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.0492|TWO_SIDED|95.0|-0.99|0.0|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-0.99|0.0492
73946082|NCT03502616|147424449|SUPERIORITY||Difference in percentage|8.31|STANDARD_ERROR_OF_MEAN|3.29||0.0116|TWO_SIDED|95.0|1.86|14.77|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.77|1.86|0.0116
73976233|NCT05886777|147497402|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 6, 4, respectively.|Geometric mean ratio|1.43|||||TWO_SIDED|97.5|1.131|1.808|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.808|1.131|
74031811|NCT01469013|147616799|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
74031812|NCT01469013|147616801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||Cochran-Armitage trend test|||||||0.009
74089255|NCT02697773|147731607|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.24||0.0004|TWO_SIDED|95.0|-1.33|-0.38|||ANCOVA|||Week 12:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.38|-1.33|0.0004
73946083|NCT03502616|147424449|SUPERIORITY||Difference in percentage|22.74|STANDARD_ERROR_OF_MEAN|4.46|<|0.0001|TWO_SIDED|95.0|13.99|31.49|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.49|13.99|<0.0001
74031813|NCT02142894|147616826|EQUIVALENCE|The results are analyzed in a 2x2 contingency table with 95%CI.|2 x 2 contingency table|87.9|||||TWO_SIDED|95.0|72.7|95.2||||||||95.2|72.7|
74031814|NCT00739297|147616827|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.04||||||95.0|-0.01|0.08|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.08|-0.01|
74031815|NCT00739297|147616827|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.1||||||95.0|0.04|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.04|
73946084|NCT03502616|147424449|SUPERIORITY||Difference in percentage|28.87|STANDARD_ERROR_OF_MEAN|4.99|<|0.0001|TWO_SIDED|95.0|19.09|38.66|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||38.66|19.09|<0.0001
73946085|NCT03502616|147424449|SUPERIORITY||Difference in percentage|31.93|STANDARD_ERROR_OF_MEAN|4.92|<|0.0001|TWO_SIDED|95.0|22.28|41.58|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||41.58|22.28|<0.0001
74031816|NCT00739297|147616827|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|0.02|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|0.02|
74031817|NCT00739297|147616827|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|-0.01|
74031818|NCT00739297|147616827|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.04|0.13|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.13|0.04|
74031819|NCT00739297|147616828|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.19||||||95.0|0.04|0.34|||||Repeated measures model with terms for treatment (Albuterol/Placebo), dose, treatment-by-dose interaction and baseline FEV1|||0.34|0.04|
74031820|NCT00739297|147616829|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|-0.01|0.12|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.12|-0.01|
74031821|NCT00739297|147616829|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.07||||||95.0|0.0|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|-0.00|
74031822|NCT00739297|147616829|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|-0.01|
74031823|NCT00739297|147616829|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|-0.03|0.14|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.14|-0.03|
74031824|NCT00739297|147616829|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.01|
74031825|NCT00739297|147616830|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.04||||||95.0|-0.03|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.10|-0.03|
74031826|NCT00739297|147616830|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.09||||||95.0|0.01|0.17|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.17|0.01|
74031827|NCT00739297|147616830|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.10|-0.01|
74031828|NCT00739297|147616830|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.07||||||95.0|-0.02|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|-0.02|
74031829|NCT00739297|147616830|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.01|
74031830|NCT00426751|147616843|NON_INFERIORITY_OR_EQUIVALENCE|For the assessment of differences between both treatment groups, a generalized model (under binomial probability distribution), adjusted for center, was applied.|Median Difference (Final Values)|2.1||||||90.0|-8.5|12.8||||||||12.8|-8.5|
74031831|NCT00426751|147616844|NON_INFERIORITY_OR_EQUIVALENCE|For the assessment of differences between both treatment groups a generalised model (under binomial probability distribution), adjusted for centre, was applied.|Mean Difference (Final Values)|6.8||||||95.0|-3.0|16.6|||||Analysis based on the ITT population confirmed the results observed in the PP population.|||16.6|-3.0|
74031832|NCT00968253|147616863|SUPERIORITY_OR_OTHER||Maximum tolerated dose|5.0|||||TWO_SIDED||||||||Maximum tolerated dose (MTD) of Everolimus measured in mg/day in combination with HyperCVAD|||||
74031833|NCT03141086|147616874|SUPERIORITY||Mean Difference (Final Values)|1.711||||0.1272|TWO_SIDED|95.0|-1.34|4.762|||ANOVA|||||4.762|-1.340|0.1272
74031834|NCT03141086|147616875|SUPERIORITY||Mean Difference (Final Values)|2.866||||0.0607|TWO_SIDED|95.0|-0.821|6.553|||Mixed Models Analysis|||3.5 hours post dose||6.553|-0.821|0.0607
74031835|NCT03141086|147616875|SUPERIORITY||Mean Difference (Net)|1.975||||0.0919|TWO_SIDED|95.0|-1.024|4.973|||Mixed Models Analysis|||5.5 hours post dose||4.973|-1.024|0.0919
73946086|NCT03502616|147424449|SUPERIORITY||Difference in percentage|25.28|STANDARD_ERROR_OF_MEAN|5.34|<|0.0001|TWO_SIDED|95.0|14.82|35.75|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||35.75|14.82|<0.0001
74031836|NCT03141086|147616875|SUPERIORITY||Mean Difference (Net)|1.576||||0.0811|TWO_SIDED|95.0|-0.697|3.848|||Mixed Models Analysis|||7.5 hours post dose||3.848|-0.697|0.0811
74031837|NCT03141086|147616875|SUPERIORITY||Mean Difference (Net)|0.879||||0.2026|TWO_SIDED|95.0|-1.268|3.026|||Mixed Models Analysis|||9.5 hours post dose||3.026|-1.268|0.2026
74031838|NCT02429427|147616894|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.751|TWO_SIDED|95.0|0.8|1.17|||Log Rank|Analysis stratified by oestrogen receptor status and country.|Analysis stratified by oestrogen receptor status and country.|||1.17|0.80|0.751
74031839|NCT02429427|147616895|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.781|TWO_SIDED|95.0|0.76|1.22|||Log Rank|Analysis is stratified for oestrogen receptor status and country.|Analysis is stratified for oestrogen receptor status and country.|||1.22|0.76|0.781
74031840|NCT06018350|147616906|OTHER|||||||0.002|||||||McNemar|||||||0.002
74031841|NCT03625986|147616908|OTHER||Mean Difference (Final Values)|-186.68||||0.0039|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0039
74031842|NCT03625986|147616909|OTHER||Mean Difference (Final Values)|-0.06||||0.8103|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8103
74031843|NCT03625986|147616910|OTHER||Mean Difference (Final Values)|-3.14||||0.0105|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0105
73869976|NCT00620113|147283571|SUPERIORITY_OR_OTHER||Difference in LS Means|-37.45||||0.001|TWO_SIDED|95.0|-60.32|-14.59||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-14.59|-60.32|0.001
73869977|NCT00620113|147283571|SUPERIORITY_OR_OTHER||Difference in LS Means|-26.77||||0.017|TWO_SIDED|95.0|-50.37|-3.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-3.16|-50.37|0.017
73869978|NCT00620113|147283572|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.52|||<|0.001|TWO_SIDED|95.0|-25.11|-5.93||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-5.93|-25.11|<0.001
73946087|NCT03502616|147424449|SUPERIORITY||Difference in percentage|10.71|STANDARD_ERROR_OF_MEAN|5.88||0.0683|TWO_SIDED|95.0|-0.8|22.23|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||22.23|-0.80|0.0683
73946088|NCT03502616|147424449|SUPERIORITY||Difference in percentage|10.05|STANDARD_ERROR_OF_MEAN|5.94||0.0906|TWO_SIDED|95.0|-1.59|21.7|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||21.70|-1.59|0.0906
73946089|NCT03502616|147424449|SUPERIORITY||Difference in percentage|13.03|STANDARD_ERROR_OF_MEAN|5.94||0.0282|TWO_SIDED|95.0|1.39|24.66|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||24.66|1.39|0.0282
73946090|NCT03502616|147424449|SUPERIORITY||Difference in percentage|10.77|STANDARD_ERROR_OF_MEAN|5.98||0.0719|TWO_SIDED|95.0|-0.96|22.49|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||22.49|-0.96|0.0719
73946091|NCT03502616|147424450|SUPERIORITY||Difference in percentage|32.79|STANDARD_ERROR_OF_MEAN|4.75|<|0.0001|TWO_SIDED|95.0|23.48|42.11|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.11|23.48|<0.0001
73946092|NCT03502616|147424450|SUPERIORITY||Difference in percentage|40.53|STANDARD_ERROR_OF_MEAN|5.19|<|0.0001|TWO_SIDED|95.0|30.37|50.7|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||50.70|30.37|<0.0001
73946093|NCT03502616|147424450|SUPERIORITY||Difference in percentage|45.22|STANDARD_ERROR_OF_MEAN|5.2|<|0.0001|TWO_SIDED|95.0|35.03|55.41|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||55.41|35.03|<0.0001
74031844|NCT03625986|147616911|OTHER||Mean Difference (Final Values)|2415.93||||0.0182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0182
73946094|NCT03502616|147424450|SUPERIORITY||Difference in percentage|45.23|STANDARD_ERROR_OF_MEAN|5.23|<|0.0001|TWO_SIDED|95.0|34.97|55.49|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||55.49|34.97|<0.0001
73946095|NCT03502616|147424450|SUPERIORITY||Difference in percentage|42.3|STANDARD_ERROR_OF_MEAN|5.4|<|0.0001|TWO_SIDED|95.0|31.73|52.88|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||52.88|31.73|<0.0001
73946096|NCT03502616|147424450|SUPERIORITY||Difference in percentage|4.96|STANDARD_ERROR_OF_MEAN|5.85||0.3967|TWO_SIDED|95.0|-6.51|16.42|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.42|-6.51|0.3967
73946097|NCT03502616|147424450|SUPERIORITY||Difference in percentage|4.34|STANDARD_ERROR_OF_MEAN|5.67||0.4442|TWO_SIDED|95.0|-6.78|15.46|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.46|-6.78|0.4442
73946098|NCT03502616|147424450|SUPERIORITY||Difference in percentage|6.38|STANDARD_ERROR_OF_MEAN|5.92||0.281|TWO_SIDED|95.0|-5.22|17.97|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.97|-5.22|0.2810
73946099|NCT03502616|147424450|SUPERIORITY||Difference in percentage|5.54|STANDARD_ERROR_OF_MEAN|5.95||0.3514|TWO_SIDED|95.0|-6.12|17.2|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.20|-6.12|0.3514
73946100|NCT03502616|147424451|SUPERIORITY||Difference in percentage|8.84|STANDARD_ERROR_OF_MEAN|2.74||0.0013|TWO_SIDED|95.0|3.46|14.21|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.21|3.46|0.0013
74031845|NCT03625986|147616912|OTHER||Mean Difference (Final Values)|1.18||||0.8429|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8429
74031846|NCT03625986|147616913|OTHER||Mean Difference (Final Values)|0.49||||0.4881|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.4881
73946101|NCT03502616|147424451|SUPERIORITY||Difference in percentage|16.25|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|95.0|9.13|23.36|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||23.36|9.13|<0.0001
73946102|NCT03502616|147424451|SUPERIORITY||Difference in percentage|20.31|STANDARD_ERROR_OF_MEAN|4.03|<|0.0001|TWO_SIDED|95.0|12.41|28.2|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||28.20|12.41|<0.0001
73946103|NCT03502616|147424451|SUPERIORITY||Difference in percentage|22.77|STANDARD_ERROR_OF_MEAN|4.24|<|0.0001|TWO_SIDED|95.0|14.46|31.08|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.08|14.46|<0.0001
73976234|NCT05886777|147497403|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 6, 4, respectively.|Geometric mean ratio|1.37|||||TWO_SIDED|97.5|1.06|1.773|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.773|1.060|
73976235|NCT05886777|147497404|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 6,3, respectively.|Geometric mean ratio|0.94|||||TWO_SIDED|97.5|0.673|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.300|0.673|
73976236|NCT05886777|147497405|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 6,3, respectively.|Geometric mean ratio|0.97|||||TWO_SIDED|97.5|0.74|1.281|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.281|0.740|
73976237|NCT05293717|147497407|OTHER|This is an open-label study. No power calculation was performed.|||||<|0.001|||||||ANOVA|||||||<0.001
73976238|NCT03762850|147497411|OTHER||Geometric Mean Ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.51|0.69|||Mixed Models Analysis|||||0.69|0.51|<0.0001
74089256|NCT02697773|147731607|SUPERIORITY||Least Square Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.52|-0.58|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.58|-1.52|<.0001
73976239|NCT03762850|147497412|OTHER||Slope difference|1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0582|TWO_SIDED|95.0|-0.03|1.94|||Mixed Models Analysis|||||1.94|-0.03|0.0582
73976240|NCT03762850|147497413|OTHER||Slope difference|1.1|STANDARD_ERROR_OF_MEAN|0.52||0.0369|TWO_SIDED|95.0|0.07|2.12|||Mixed Models Analysis|||||2.12|0.07|0.0369
73946104|NCT03502616|147424451|SUPERIORITY||Difference in percentage|25.28|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|95.0|16.47|34.1|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||34.10|16.47|<0.0001
73946105|NCT03502616|147424451|SUPERIORITY||Difference in percentage|9.41|STANDARD_ERROR_OF_MEAN|5.62||0.0941|TWO_SIDED|95.0|-1.61|20.43|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||20.43|-1.61|0.0941
74009027|NCT00709111|147568721|SUPERIORITY_OR_OTHER|||||||0.97||||||The p-value is one-sided with a nominal level of 0.05.|Wilcoxon signed-rank, 1-sided|||The change in CD4+ T-cell count from baseline to week 24 was compared against the null hypothesis of change \<20 cells/mm\^3. The study was powered to yield 80% power to show that there was \>=20 cells/mm\^3 increase in CD4+ T-cell count assuming an underlying change in CD4+ T-cell counts induced by MVC of 50 cells/mm\^3, a standard deviation of 60 cells/mm\^3 around the mean CD4+ T-cell count change, 10% lost-to-follow-up or premature MVC discontinuation rate, and one-sided type 1 error of 0.05.||||0.97
73946106|NCT03502616|147424451|SUPERIORITY||Difference in percentage|2.52|STANDARD_ERROR_OF_MEAN|5.96||0.6727|TWO_SIDED|95.0|-9.17|14.21|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.21|-9.17|0.6727
73946107|NCT03502616|147424451|SUPERIORITY||Difference in percentage|7.29|STANDARD_ERROR_OF_MEAN|5.96||0.2213|TWO_SIDED|95.0|-4.39|18.98|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.98|-4.39|0.2213
74009028|NCT01301456|147568782|SUPERIORITY_OR_OTHER||Least square (LS) mean|-21.16|STANDARD_ERROR_OF_MEAN|16.766||0.219|TWO_SIDED|80.0|-43.26|0.93|||Mixed meal tolerance test|||Day 30||0.93|-43.26|0.219
74009029|NCT01301456|147568782|SUPERIORITY_OR_OTHER||LS mean|-34.18|STANDARD_ERROR_OF_MEAN|15.189||0.034|TWO_SIDED|80.0|-54.2|-14.16|||Mixed meal tolerance test|||Day 30||-14.16|-54.20|0.034
74009030|NCT01301456|147568782|SUPERIORITY_OR_OTHER||LS mean|-33.67|STANDARD_ERROR_OF_MEAN|15.806||0.044|TWO_SIDED|80.0|-54.5|-12.84|||Mixed meal tolerance test|||Day 30||-12.84|-54.50|0.044
74009031|NCT01301456|147568782|SUPERIORITY_OR_OTHER||LS mean|-2.93|STANDARD_ERROR_OF_MEAN|16.111||0.857|TWO_SIDED|80.0|-24.16|18.31|||Mixed meal tolerance test|||Day 30||18.31|-24.16|0.857
73946108|NCT03502616|147424451|SUPERIORITY||Difference in percentage|4.7|STANDARD_ERROR_OF_MEAN|5.76||0.4137|TWO_SIDED|95.0|-6.58|15.98|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.98|-6.58|0.4137
73946109|NCT03502616|147424452|SUPERIORITY||Difference in percentage|0.75|STANDARD_ERROR_OF_MEAN|1.27||0.5518|TWO_SIDED|95.0|-1.73|3.24|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||3.24|-1.73|0.5518
73946110|NCT03502616|147424452|SUPERIORITY||Difference in percentage|3.72|STANDARD_ERROR_OF_MEAN|1.92||0.0524|TWO_SIDED|95.0|-0.04|7.47|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||7.47|-0.04|0.0524
73946111|NCT03502616|147424452|SUPERIORITY||Difference in percentage|5.25|STANDARD_ERROR_OF_MEAN|2.29||0.0216|TWO_SIDED|95.0|0.77|9.73|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.73|0.77|0.0216
73946112|NCT03502616|147424452|SUPERIORITY||Difference in percentage|10.48|STANDARD_ERROR_OF_MEAN|2.9||0.0003|TWO_SIDED|95.0|4.8|16.17|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.17|4.80|0.0003
73946113|NCT03502616|147424452|SUPERIORITY||Difference in percentage|6.69|STANDARD_ERROR_OF_MEAN|2.37||0.0047|TWO_SIDED|95.0|2.05|11.33|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||11.33|2.05|0.0047
73946114|NCT03502616|147424452|SUPERIORITY||Difference in percentage|1.07|STANDARD_ERROR_OF_MEAN|3.98||0.7883|TWO_SIDED|95.0|-6.74|8.88|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||8.88|-6.74|0.7883
74031847|NCT03625986|147616914|OTHER||Mean Difference (Final Values)|1.76||||0.0835|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0835
73946115|NCT03502616|147424452|SUPERIORITY||Difference in percentage|4.85|STANDARD_ERROR_OF_MEAN|4.4||0.2708|TWO_SIDED|95.0|-3.78|13.48|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||13.48|-3.78|0.2708
73946116|NCT03502616|147424452|SUPERIORITY||Difference in percentage|0.44|STANDARD_ERROR_OF_MEAN|4.55||0.9226|TWO_SIDED|95.0|-8.48|9.36|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.36|-8.48|0.9226
73946117|NCT03502616|147424452|SUPERIORITY||Difference in percentage|1.84|STANDARD_ERROR_OF_MEAN|4.23||0.663|TWO_SIDED|95.0|-6.44|10.13|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||10.13|-6.44|0.6630
73946118|NCT03502616|147424453|SUPERIORITY||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.319||0.0099|TWO_SIDED|95.0|-1.47|-0.2|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-1.47|0.0099
73946119|NCT03502616|147424453|SUPERIORITY||LS mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.332||0.0275|TWO_SIDED|95.0|-1.4|-0.08|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.08|-1.40|0.0275
73946120|NCT03502616|147424453|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.35||0.042|TWO_SIDED|95.0|-1.41|-0.03|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-1.41|0.0420
73946121|NCT03502616|147424453|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.349||0.1309|TWO_SIDED|95.0|-1.22|0.16|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.16|-1.22|0.1309
73946122|NCT03502616|147424453|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.305||0.5566|TWO_SIDED|95.0|-0.78|0.42|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.42|-0.78|0.5566
73946123|NCT03502616|147424453|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.248||0.4497|TWO_SIDED|95.0|-0.68|0.3|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.30|-0.68|0.4497
73946124|NCT03502616|147424453|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.227||0.9272|TWO_SIDED|95.0|-0.43|0.47|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.47|-0.43|0.9272
74031848|NCT03625986|147616915|OTHER||Mean Difference (Final Values)|-0.96||||0.043|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.043
74031849|NCT03625986|147616916|OTHER||Odds Ratio (OR)|4.35||||0.0052|TWO_SIDED||||||Fisher Exact|||||||0.0052
74031850|NCT03625986|147616917|OTHER||Mean Difference (Final Values)|-1.95||||0.0797|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0797
74031851|NCT03625986|147616918|OTHER||Mean Difference (Final Values)|-1.44||||0.1084|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1084
74031852|NCT03625986|147616919|OTHER||Mean Difference (Final Values)|3.81||||0.3469|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3469
74031853|NCT03625986|147616920|OTHER||Odds Ratio (OR)|3.3632||||0.0272|TWO_SIDED||||||Fisher Exact|||||||0.0272
73946125|NCT03502616|147424453|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.273||0.2539|TWO_SIDED|95.0|-0.85|0.23|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.23|-0.85|0.2539
73946126|NCT03502616|147424454|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.479||0.4379|TWO_SIDED|95.0|-0.58|1.33|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.33|-0.58|0.4379
73946127|NCT03502616|147424454|SUPERIORITY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.532||0.534|TWO_SIDED|95.0|-0.73|1.39|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.39|-0.73|0.5340
73946128|NCT03502616|147424454|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.582||0.9148|TWO_SIDED|95.0|-1.1|1.22|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.22|-1.10|0.9148
73946129|NCT03502616|147424454|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.548||0.5409|TWO_SIDED|95.0|-1.43|0.76|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.76|-1.43|0.5409
73946130|NCT03502616|147424454|SUPERIORITY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.607||0.3555|TWO_SIDED|95.0|-1.78|0.65|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.65|-1.78|0.3555
73946131|NCT03502616|147424454|SUPERIORITY||LS mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.436||0.2485|TWO_SIDED|95.0|-0.36|1.38|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.38|-0.36|0.2485
73946132|NCT03502616|147424454|SUPERIORITY||LS mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.435||0.0866|TWO_SIDED|95.0|-0.11|1.63|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.63|-0.11|0.0866
73946133|NCT03502616|147424454|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.356||0.4101|TWO_SIDED|95.0|-0.42|1.01|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.01|-0.42|0.4101
73946134|NCT03502616|147424454|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.217||0.0237|TWO_SIDED|95.0|0.07|0.94|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.94|0.07|0.0237
73946135|NCT03502616|147424455|SUPERIORITY||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.107||0.0043|TWO_SIDED|95.0|0.1|0.52|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.52|0.10|0.0043
73946136|NCT03502616|147424455|SUPERIORITY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.121||0.0072|TWO_SIDED|95.0|0.09|0.56|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.56|0.09|0.0072
73946137|NCT03502616|147424455|SUPERIORITY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.146||0.1101|TWO_SIDED|95.0|-0.05|0.52|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.52|-0.05|0.1101
73946138|NCT03502616|147424455|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.13||0.0147|TWO_SIDED|95.0|0.06|0.58|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.58|0.06|0.0147
74009032|NCT01301456|147568783|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.251||0.419|TWO_SIDED|80.0|-0.54|0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.12|-0.54|0.419
74009033|NCT01301456|147568783|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.224||0.077|TWO_SIDED|80.0|-0.71|-0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.12|-0.71|0.077
74031854|NCT03625986|147616921|OTHER||Mean Difference (Final Values)|0.6||||0.589|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.589
73869979|NCT00620113|147283572|SUPERIORITY_OR_OTHER||Difference in LS Means|-12.55||||0.009|TWO_SIDED|95.0|-22.16|-2.94||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-2.94|-22.16|0.009
73946139|NCT03502616|147424455|SUPERIORITY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.162||0.2032|TWO_SIDED|95.0|-0.11|0.53|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.53|-0.11|0.2032
73869980|NCT00620113|147283572|SUPERIORITY_OR_OTHER||Difference in LS Means|2.48||||0.598|TWO_SIDED|95.0|-7.79|12.74||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||12.74|-7.79|0.598
73869981|NCT00620113|147283573|SUPERIORITY_OR_OTHER||Difference in LS Means|-26.86|||<|0.001|TWO_SIDED|95.0|-43.3|-10.42||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-10.42|-43.30|<0.001
73946140|NCT03502616|147424455|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.168||0.9345|TWO_SIDED|95.0|-0.34|0.32|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.32|-0.34|0.9345
73946141|NCT03502616|147424455|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.187||0.5968|TWO_SIDED|95.0|-0.47|0.27|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.27|-0.47|0.5968
73946142|NCT03502616|147424455|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.166||0.7047|TWO_SIDED|95.0|-0.26|0.39|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.39|-0.26|0.7047
73976241|NCT02036970|147497436|SUPERIORITY||Mean Difference (Net)|-1.74||||0.8133|TWO_SIDED|95.0|-16.22|12.74||The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary arterial hypertension (PAH).|Mixed Models Analysis||Mean difference (Net) = Bardoxolone methyl - Placebo.|Overall treatment effect in participants with PAH. Mean overall treatment effect across all visits for change from baseline in 6MWD was estimated and compared with placebo through 16 weeks of treatment using mixed-model repeated measures (MMRM), with treatment group, visit, and the interaction between treatment and visit as fixed factors. A compound symmetry covariance matrix was assumed. Data from Wks 4, 8, 12, and 16 used in the model with the change from baseline at Wk16 as primary endpoint.||12.74|-16.22|0.8133
73869982|NCT00620113|147283573|SUPERIORITY_OR_OTHER||Difference in LS Means|-28.86|||<|0.001|TWO_SIDED|95.0|-44.97|-12.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-12.75|-44.97|<0.001
73946143|NCT03502616|147424455|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.157||0.807|TWO_SIDED|95.0|-0.27|0.35|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.35|-0.27|0.8070
73946144|NCT03502616|147424456|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.055||0.003|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 16, Mobility: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-0.06|-0.28|0.0030
74009034|NCT01301456|147568783|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.23||0.147|TWO_SIDED|80.0|-0.65|-0.04|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.04|-0.65|0.147
74031855|NCT03625986|147616922|OTHER||Mean Difference (Final Values)|-0.3||||0.5448|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5448
74009035|NCT01301456|147568783|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.244||0.086|TWO_SIDED|80.0|-0.76|-0.11|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.11|-0.76|0.086
74009036|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|4.11|STANDARD_ERROR_OF_MEAN|9.326||0.663|TWO_SIDED|80.0|-8.16|16.37|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||16.37|-8.16|0.663
73946145|NCT03502616|147424456|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.055||0.897|TWO_SIDED|95.0|-0.11|0.1|||ANCOVA|||Week 16, Self-Care: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.10|-0.11|0.8970
73946146|NCT03502616|147424456|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.058||0.1437|TWO_SIDED|95.0|-0.2|0.03|||ANCOVA|||Week 16, Usual Activities: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.03|-0.20|0.1437
73946147|NCT03502616|147424456|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|95.0|-0.27|-0.09|||ANCOVA|||Week 16, Pain/Discomfort: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-0.09|-0.27|<0.0001
73946148|NCT03502616|147424456|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.061||0.8445|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Week 16, Anxiety/Depression: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.11|-0.13|0.8445
73946149|NCT03502616|147424456|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.064||0.3473|TWO_SIDED|95.0|-0.19|0.07|||Mixed Models Analysis|||Week 48, Mobility: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.07|-0.19|0.3473
73946150|NCT03502616|147424456|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.059||0.9834|TWO_SIDED|95.0|-0.12|0.12|||Mixed Models Analysis|||Week 48, Self-Care: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.12|-0.12|0.9834
73946151|NCT03502616|147424456|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.066||0.7364|TWO_SIDED|95.0|-0.11|0.15|||Mixed Models Analysis|||Week 48, Usual Activities: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.15|-0.11|0.7364
73946152|NCT03502616|147424456|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.059||0.8075|TWO_SIDED|95.0|-0.13|0.1|||Mixed Models Analysis|||Week 48, Pain/Discomfort: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.10|-0.13|0.8075
73946153|NCT03502616|147424456|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.067||0.5461|TWO_SIDED|95.0|-0.09|0.17|||Mixed Models Analysis|||Week 48, Anxiety/Depression: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.17|-0.09|0.5461
73946154|NCT03502616|147424457|SUPERIORITY||LS mean difference|10.11|STANDARD_ERROR_OF_MEAN|2.331|<|0.0001|TWO_SIDED|95.0|5.52|14.7|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||14.70|5.52|<0.0001
73976242|NCT02036970|147497436|SUPERIORITY||Mean Difference (Net)|-3.17||||0.759|TWO_SIDED|95.0|-23.54|17.2||The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary hypertension (PH)|Mixed Models Analysis||Mean difference (Net) = Bardoxolone methyl - Placebo.|Overall treatment effect in participants with PH. Mean overall treatment effect across all visits for change from baseline in 6MWD was estimated \& compared with placebo through 16 wks of treatment using mixed-model repeated measures (MMRM), with treatment group, visit, and the interaction between treatment \& visit as fixed factors. Compound symmetry covariance matrix was assumed. Data from Wks 4, 8, 12, and 16 were used in the model with the change from baseline at Wk 16 as the primary endpoint||17.20|-23.54|0.759
73946155|NCT03502616|147424457|SUPERIORITY||LS mean difference|2.63|STANDARD_ERROR_OF_MEAN|2.337||0.2608|TWO_SIDED|95.0|-1.97|7.24|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.24|-1.97|0.2608
73946156|NCT03502616|147424458|SUPERIORITY||LS mean difference|-4.53|STANDARD_ERROR_OF_MEAN|3.35||0.1784|TWO_SIDED|95.0|-11.15|2.09|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||2.09|-11.15|0.1784
74009037|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|8.472||0.825|TWO_SIDED|80.0|-13.03|9.25|||mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.25|-13.03|0.825
74031856|NCT03625986|147616923|OTHER||Mean Difference (Final Values)|15.3||||0.65|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.65
74031857|NCT03625986|147616924|OTHER||Mean Difference (Final Values)|-4.0||||0.1567|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1567
73946157|NCT03502616|147424458|SUPERIORITY||LS mean difference|-2.31|STANDARD_ERROR_OF_MEAN|2.54||0.3651|TWO_SIDED|95.0|-7.34|2.72|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.72|-7.34|0.3651
73946158|NCT03502616|147424459|SUPERIORITY||LS mean difference|-12.89|STANDARD_ERROR_OF_MEAN|2.884|<|0.0001|TWO_SIDED|95.0|-18.59|-7.19|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-7.19|-18.59|<0.0001
73946159|NCT03502616|147424459|SUPERIORITY||LS mean difference|-2.36|STANDARD_ERROR_OF_MEAN|3.318||0.4788|TWO_SIDED|95.0|-8.92|4.21|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.21|-8.92|0.4788
73946160|NCT03502616|147424460|SUPERIORITY||LS mean difference|-13.85|STANDARD_ERROR_OF_MEAN|3.202|<|0.0001|TWO_SIDED|95.0|-20.18|-7.52|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-7.52|-20.18|<0.0001
73946161|NCT03502616|147424460|SUPERIORITY||LS mean difference|-4.41|STANDARD_ERROR_OF_MEAN|3.613||0.2244|TWO_SIDED|95.0|-11.56|2.74|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.74|-11.56|0.2244
73946162|NCT03502616|147424461|SUPERIORITY||LS mean difference|-13.4|STANDARD_ERROR_OF_MEAN|2.488|<|0.0001|TWO_SIDED|95.0|-18.3|-8.5|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-8.50|-18.30|<0.0001
73946163|NCT03502616|147424461|SUPERIORITY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.905||0.0095|TWO_SIDED|95.0|-13.32|-1.88|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.88|-13.32|0.0095
73946164|NCT02237508|147424486|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|138.87|||<|0.001|TWO_SIDED|90.0|129.09|149.39|||Mixed Models Analysis|||||149.39|129.09|<0.001
73946165|NCT02237508|147424486|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|136.18|||<|0.001|TWO_SIDED|90.0|126.13|147.04|||Mixed Models Analysis|||||147.04|126.13|<0.001
73946166|NCT02237508|147424487|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|119.73||||0.001|TWO_SIDED|90.0|109.4|131.03|||Mixed Models Analysis|||||131.03|109.40|0.001
73946167|NCT02237508|147424487|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|129.62|||<|0.001|TWO_SIDED|90.0|117.33|143.2|||Mixed Models Analysis|||||143.20|117.33|<0.001
73946168|NCT02237508|147424488|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|218.13|||<|0.001|TWO_SIDED|90.0|194.02|245.24|||Mixed Models Analysis|||||245.24|194.02|<0.001
73976243|NCT02298842|147497437|NON_INFERIORITY|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH\> 6.2 will be at least 95%. This will be achieved if zero failures (pH\<=6.2) is seen.|Simple sample proportion|100.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|95.1||||Exact Binomial Confidence Interval||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"A success is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria."|||95.1|
73946169|NCT02237508|147424488|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|200.66|||<|0.001|TWO_SIDED|90.0|174.3|231.01|||Mixed Models Analysis|||||231.01|174.30|<0.001
73946170|NCT02237508|147424489|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|126.17|||<|0.001|TWO_SIDED|90.0|115.93|137.32|||Mixed Models Analysis|||||137.32|115.93|<0.001
73946171|NCT02237508|147424489|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|117.08||||0.004|TWO_SIDED|90.0|107.05|128.05|||Mixed Models Analysis|||||128.05|107.05|0.004
73946172|NCT05807919|147424514|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73946173|NCT05807919|147424515|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
73946174|NCT05807919|147424516|SUPERIORITY|||||||0.18|||||||Fisher Exact|||||||0.18
73976244|NCT02298842|147497438|NON_INFERIORITY|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH\> 6.2 will be at least 95%. This will be achieved if zero failures (pH\<=6.2) is seen.|Simple sample proportion|100.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|95.1||||Exact Bionomial Confidence Interval||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"A success is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria."|||95.1|
73976245|NCT02298842|147497439|NON_INFERIORITY|If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|15.099|STANDARD_DEVIATION|5.6367|||ONE_SIDED|97.5||16.738|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selectin's mean difference, Test - 1.25 \* Control, is greater than or equal to 0, and the alternative is that the mean difference is less than 0.||16.738||
73976246|NCT02298842|147497440|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Median Difference (Final Values)|-0.418|STANDARD_DEVIATION|4.5531|||ONE_SIDED|97.5|-1.544||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-1.544|
73946175|NCT05807919|147424517|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
73946176|NCT05807919|147424518|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
73946177|NCT05807919|147424519|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
73976247|NCT02298842|147497441|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-0.667|STANDARD_DEVIATION|6.7882|||ONE_SIDED|97.5|-2.499||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-2.499|
74009038|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|8.791||0.878|TWO_SIDED|80.0|-10.2|12.92|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||12.92|-10.20|0.878
73946178|NCT01905046|147424520|SUPERIORITY||Odds Ratio (OR)|0.97||||0.951|TWO_SIDED|95.0|0.36|2.62|||Chi-squared|||||2.62|0.36|0.951
73946179|NCT03489057|147424533|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
73946180|NCT03489057|147424547|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||||||0.48
73946181|NCT01622010|147424573|EQUIVALENCE|P value 0.05 used||||||0.487|||||||Chi-squared|||||||0.487
73946182|NCT01622010|147424575|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|a non-inferiority margin calculation was not performed for this study prior to its start.||||||0.628|||||||Fisher Exact|||Null hypothesis: Standard care is better than standard care with video enhancement.||||0.628
73946183|NCT01622010|147424576|EQUIVALENCE|P Value 0.05 used||||||0.647|||||||Chi-squared|||||||0.647
73946184|NCT01552954|147424578|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||for albuminuria changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||Differences with two-tailed P\<0.05 were considered statistically significant.||||0.006
73946185|NCT01552954|147424578|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks|Mixed Models Analysis|||||||0.99
73946186|NCT01552954|147424578|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks in intensive education group|Mixed Models Analysis|||||||0.001
73946187|NCT01552954|147424579|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED|||||for hemoglobin changes from week 0 at week 16 (week 0 - week 16)|t-test, 2 sided|||||||0.187
73946188|NCT01552954|147424580|SUPERIORITY_OR_OTHER|||||||0.001||||||for changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||0.001
73946189|NCT01552954|147424581|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||for sBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||>0.05
73946190|NCT01552954|147424581|SUPERIORITY_OR_OTHER|||||||0.585|TWO_SIDED|||||for dBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||0.585
73946191|NCT04843930|147424582|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.54|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 261.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.54
73946192|NCT04843930|147424583|SUPERIORITY||Mean Difference (Final Values)|2.83||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 239.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis."||||0.04
73958119|NCT04897737|147451960|SUPERIORITY||Risk Ratio (RR)|3.89|||<|0.001|TWO_SIDED|95.0|2.08|7.27|||Regression, Linear|||All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and 95% CIs.|RD=49.1% (95% CI=32.8, 65.3), p\<0.001|7.27|2.08|<0.001
73958120|NCT04059237|147451962|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<0.001
74009039|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|8.829||0.936|TWO_SIDED|80.0|-10.89|12.33|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||12.33|-10.89|0.936
74009040|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|13.037||0.959|TWO_SIDED|80.0|-16.46|17.82|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||17.82|-16.46|0.959
73946193|NCT04843930|147424584|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.79|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 229.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.79
73946194|NCT04843930|147424585|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.45|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 269.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.45
73946195|NCT04843930|147424586|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.02|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 236.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.02
73946196|NCT04843930|147424587|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.96|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 257.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.96
73946197|NCT04843930|147424588|SUPERIORITY||Mean Difference (Final Values)|2.78||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 262.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.04
73946198|NCT04843930|147424589|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.6|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 227.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.60
73976248|NCT02298842|147497442|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|46.1|STANDARD_DEVIATION|23.056|||ONE_SIDED|97.5|40.02||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||40.020|
73976249|NCT02298842|147497443|NON_INFERIORITY|Lower value is considered to indicate better platelet quality. If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|12.314|STANDARD_DEVIATION|6.0422|||ONE_SIDED|97.5||13.981|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selection's mean difference, Test - 1.25 \* Control, is greater or equal to 0, and the alternative is that the mean difference is less than 0.||13.981||
74009041|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.46|STANDARD_ERROR_OF_MEAN|11.872||0.011|TWO_SIDED|80.0|-48.07|-16.85|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-16.85|-48.07|0.011
74031858|NCT01096446|147616935|NON_INFERIORITY_OR_EQUIVALENCE|The Chi Square satistical calculation was used for analysis.||||||0.011|TWO_SIDED|95.0|||||Chi-squared|||Four infants(44%)in the control group developed hypertriglyceridemia (\>200 mg/dl) while 100% of the infants in the experimental group developed hypertriglyceridemia (\>200 mg/dl) during the first week of life.||||0.011
74039475|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.38||0.0013|TWO_SIDED|95.0|-1.96|-0.48|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.48|-1.96|0.0013
73946199|NCT04843930|147424590|SUPERIORITY||Mean Difference (Final Values)|3.77||||0.06|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 1, 89.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.06
73946200|NCT04843930|147424591|SUPERIORITY||Mean Difference (Final Values)|4.37||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 1, 73.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.04
73946201|NCT02439749|147424638|SUPERIORITY||||||<|0.001||||||p\<0.05 required for significance|ANCOVA|||||||<0.001
73946202|NCT02439749|147424642|SUPERIORITY|||||||0.026||||||p\<0.05 required for significance.|ANCOVA|||||||0.026
73946203|NCT02439749|147424643|SUPERIORITY|||||||0.052||||||p\<0.05 required for significance.|ANCOVA|||||||0.052
73946204|NCT02439749|147424644|SUPERIORITY|||||||0.07||||||p\<0.05 required for significance.|ANCOVA|||||||0.070
73946205|NCT02439749|147424645|SUPERIORITY|||||||0.009||||||p=\<0.05 required for significance.|ANCOVA|||||||0.009
73946206|NCT02202434|147424681|NON_INFERIORITY|10.5% non-inferiority margin|Difference in Percentages|3.1||||0.0027|ONE_SIDED|97.5||8.32|||Farrington-Manning|||||8.32||0.0027
73946207|NCT02202434|147424682|NON_INFERIORITY|9.5% Non-Inferiority margin|Difference in Percentages|-10.1|||<|0.0001|ONE_SIDED|97.5||-4.41|||Farrington-Manning|||||-4.41||<0.0001
73946208|NCT02202434|147424682|SUPERIORITY||Difference in Percentages|-10.2||||0.0006|TWO_SIDED|95.0|-16.3|-4.0|||Chi-squared|||"Superiority analysis was only to be run if the non-inferiority analysis was met.~Superiority analysis was run on Intent to Treat Population."||-4.0|-16.3|0.0006
73946209|NCT02202434|147424683|SUPERIORITY||Difference in Percentages|-6.1|||<|0.0001|TWO_SIDED|95.0|-9.6|-2.6|||Chi-squared|||||-2.6|-9.6|<0.0001
73946210|NCT02991482|147424722|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
73946211|NCT00871403|147424749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.2647|TWO_SIDED|95.0|0.43|1.28|||Log Rank||The hazard ratios is estimated using a Pike estimator. The estimated value is the hazard ratio comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\^2 to Cisplatin 75 mg/m\^2 plus pemetrexed 500 mg/m\^2.|||1.28|0.43|0.2647
73946212|NCT00871403|147424752|SUPERIORITY_OR_OTHER||percent difference in response|-12.0||||0.2113|TWO_SIDED|95.0|-30.6|7.2|||Binomial asymptotic||The estimated value is the percent difference in the response rate comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\^2 to Cisplatin 75 mg/m\^2 plus pemetrexed 500 mg/m\^2.|||7.2|-30.6|0.2113
73946213|NCT01691521|147424787|SUPERIORITY_OR_OTHER||Rate Ratio|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.72||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.72|0.40|<0.001
73946214|NCT01691521|147424787|SUPERIORITY_OR_OTHER||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.35|0.64||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 100 mg SC arm divided by the number of exacerbations per year in the placebo arm.|||0.64|0.35|<0.001
73946215|NCT00770432|147424809|SUPERIORITY_OR_OTHER|||||||0.0595||95.0|||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel adjusted for study site (the smallest study sites were pooled according to a pre-specified rule).||||||0.0595
73946216|NCT00818363|147424812|SUPERIORITY||LS Mean Difference|-0.64||||0.303|TWO_SIDED|95.0|-1.74|0.47|||ANCOVA|Includes treatment group and trial site as factors and age as a covariate.||||0.47|-1.74|0.303
73946217|NCT00818363|147424813|SUPERIORITY||LS Mean Difference|-10.25||||0.303|TWO_SIDED|95.0|-30.04|9.55|||ANCOVA|Includes treatment group and trial site as factors and age as a covariate.||||9.55|-30.04|0.303
73946218|NCT00988221|147424841|SUPERIORITY_OR_OTHER||Adjusted mean - Placebo|-22.3||||||||||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||||
73946219|NCT00988221|147424841|SUPERIORITY_OR_OTHER||Adjusted mean - Tocilizumab|-32.4||||||||||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||||
74089257|NCT02697773|147731609|SUPERIORITY||Least Mean Square Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0236|TWO_SIDED|95.0|-0.32|-0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.02|-0.32|0.0236
74089258|NCT02697773|147731609|SUPERIORITY||Least Square Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0958|TWO_SIDED|95.0|-0.27|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis subscale and baseline diary average pain as covariate, and study site as a random effect.||0.02|-0.27|0.0958
73946220|NCT00988221|147424841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.0076|TWO_SIDED|95.0|-17.6|-2.7||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||-2.7|-17.6|0.0076
73946221|NCT00988221|147424842|SUPERIORITY_OR_OTHER||Weighted difference|18.0||||1|TWO_SIDED|95.0|5.0|32.0||1.000 is used here as the test was considered as not significant due to the break in the hierarchical testing chain.|Cochran-Mantel-Haenszel|The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.||The analysis used the Cochran-Mantel-Haenszel test adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.||32|5|1.000
73946222|NCT00633919|147424861|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0|||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.85
73946223|NCT00633919|147424862|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED|95.0|||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.52
73946224|NCT00633919|147424863|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||>0.05
73946225|NCT00633919|147424864|SUPERIORITY_OR_OTHER|||||||0.0486||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.0486
73946226|NCT00633919|147424865|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||>0.05
73946227|NCT01991821|147424888|SUPERIORITY|||||||0.093||||||The complete response of the primary efficacy analysis occurred in 95 patients (56.2%; 95% confidence interval \[CI\] 48.4 - 63.8%) in the APD421 group and 83 patients (46.6%; 95% CI 39.1- 54.2%) in the placebo group|Chi-squared, Corrected|Pearson square test with Yates's continuity correction and with the two- sided significance level of 5%||The primary efficacy analysis was a complete response which is defined as protection from PONV1, which was absence of any episode of emesis, significant nausea or use of rescue medication with the first 24 hours post-operatively.||||0.093
73946228|NCT01991821|147424889|SUPERIORITY|||||||0.059||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.059
73946229|NCT01991821|147424890|SUPERIORITY|||||||0.053||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.053
73946230|NCT01991821|147424891|SUPERIORITY|||||||0.26||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.26
73946231|NCT01991821|147424892|SUPERIORITY|||||||0.06||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.06
73946232|NCT01991821|147424893|SUPERIORITY|||||||0.079||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.079
73946233|NCT01991821|147424894|SUPERIORITY|||||||0.096|||||||Chi-squared, Corrected|||||||0.096
73946234|NCT04203537|147424895|SUPERIORITY|||||||0.0004|||||||ANOVA|||||||0.0004
73946235|NCT04203537|147424896|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73946236|NCT04203537|147424896|SUPERIORITY|||||||0.0026|||||||ANOVA|||||||0.0026
73946237|NCT04581200|147424897|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.61|TWO_SIDED|95.0|-1.63|2.8|||t-test, 2 sided|||||2.80|-1.63|0.61
73946238|NCT04581200|147424898|OTHER|This is an exploratory pilot trial|Mean Difference (Final Values)|0.21||||0.89|TWO_SIDED|95.0|-2.66|3.08|||t-test, 2 sided|||||3.08|-2.66|0.89
73946239|NCT04581200|147424899|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.81|TWO_SIDED|95.0|-2.58|3.3|||t-test, 2 sided|||||3.30|-2.58|0.81
73946240|NCT04581200|147424900|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.75|TWO_SIDED|95.0|-2.98|2.14|||t-test, 2 sided|||||2.14|-2.98|0.75
73946241|NCT04581200|147424901|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.45|TWO_SIDED|95.0|-0.57|0.74|||t-test, 2 sided|||||0.74|-0.57|0.45
73946242|NCT04581200|147424902|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.98|TWO_SIDED|95.0|-0.13|0.13|||t-test, 2 sided|||||0.13|-0.13|0.98
73946243|NCT04581200|147424903|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
73946244|NCT04581200|147424904|SUPERIORITY|||||||0.69|||||||Fisher Exact|||||||0.69
74031859|NCT01109004|147616953|SUPERIORITY|||||||0.87||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.87
73946245|NCT03131960|147424927|SUPERIORITY|||||||0.0014|||||||ANCOVA|||||||0.0014
73946246|NCT03131960|147424928|SUPERIORITY|||||||0.0077|||||||ANCOVA|||ANCOVA||||0.0077
73946247|NCT03131960|147424929|SUPERIORITY|||||||0.0098|||||||Regression, Logistic|||||||0.0098
73946248|NCT03131960|147424930|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73946249|NCT01625923|147424949|OTHER|T-test comparing GCSI-DD scores before/after intervention||||||0.06|||||||t-test, 2 sided|||||||.06
73946250|NCT03485911|147424963|SUPERIORITY||negative binomial regression model|30.0||||0.024|TWO_SIDED|95.0|4.6|48.7|||negative binomial regression model|||||48.7|4.6|0.024
73946251|NCT03485911|147424963|SUPERIORITY||negative binomial regression model|44.2|||<|0.001|TWO_SIDED|95.0|23.0|59.5|||negative binomial regression model|||||59.5|23.0|<0.001
73946252|NCT03485911|147424965|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.453|TWO_SIDED|95.0|-10.08|4.53|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups.||4.53|-10.08|0.453
73946253|NCT03485911|147424965|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.188|TWO_SIDED|95.0|-12.23|2.43|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups.||2.43|-12.23|0.188
73946254|NCT03485911|147424966|SUPERIORITY||Difference in Least Square Means|-0.062||||0.025|TWO_SIDED|95.0|-0.117|-0.008|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of proportion of days with angioedema symptoms through 24 weeks for statistical significance would not be completed. P-values that are reported are nominal.||-0.008|-0.117|0.025
73946255|NCT03485911|147424966|SUPERIORITY||Difference in Least Square Means|-0.078||||0.006|TWO_SIDED|95.0|-0.133|-0.023|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of number and proportion of days with angioedema symptoms through 24 weeks for statistical significance would not be completed. P-values that are reported are nominal.||-0.023|-0.133|0.006
73946256|NCT03485911|147424967|SUPERIORITY||negative binomial regression model|30.4||||0.026|TWO_SIDED|95.0|4.3|49.3|||negative binomial regression model|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of rate of expert-confirmed HAE attacks during dosing in the effective treatment period for statistical significance would not be completed. P-values reported are nominal.||49.3|4.3|0.026
73946257|NCT03485911|147424967|SUPERIORITY||negative binomial regression model|46.5|||<|0.001|TWO_SIDED|95.0|25.6|61.5|||negative binomial regression model|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of rate of expert-confirmed HAE attacks during dosing in the effective treatment period for statistical significance would not be completed. P-values reported are nominal.||61.5|25.6|<0.001
73946258|NCT02481375|147424971|OTHER||Marginal means|0.0|||<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||Marginal means (95% CI) of ferritin concentrations at 12-weeks using a generalized mixed-effects model with adjustments for baseline values and village clusters||||<0.05
73946259|NCT05436912|147425000|OTHER||Geometric Mean Ratio|168.9||||0.3601|TWO_SIDED|90.0|61.3|465.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||465.3|61.3|0.3601
73946260|NCT05436912|147425000|OTHER||Geometric Mean Ratio|92.2||||0.9146|TWO_SIDED|90.0|23.0|368.9|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||368.9|23.0|0.9146
73946261|NCT05436912|147425000|OTHER||Geometric Mean Ratio|119.6||||0.7478|TWO_SIDED|90.0|43.4|329.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||329.3|43.4|0.7478
73946262|NCT05436912|147425002|OTHER||Geometric Mean Ratio|126.1||||0.4279|TWO_SIDED|90.0|74.8|212.8|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||212.8|74.8|0.4279
73946263|NCT05436912|147425002|OTHER||Geometric Mean Ratio|92.4||||0.8341|TWO_SIDED|90.0|46.4|183.9|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||183.9|46.4|0.8341
73946264|NCT05436912|147425002|OTHER||Geometric Mean Ratio|169.1||||0.1159|TWO_SIDED|90.0|97.1|294.6|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||294.6|97.1|0.1159
73946265|NCT05436912|147425003|OTHER||Geometric Mean Ratio|126.0||||0.4289|TWO_SIDED|90.0|74.8|212.4|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||212.4|74.8|0.4289
73976250|NCT02298842|147497444|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-3.042|STANDARD_DEVIATION|5.422|||ONE_SIDED|97.5|-4.407||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-4.407|
73976251|NCT02298842|147497445|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-2.389|STANDARD_DEVIATION|9.0544|||ONE_SIDED|97.5|-4.915||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-4.915|
73946266|NCT05436912|147425003|OTHER||Geometric Mean Ratio|92.3||||0.8322|TWO_SIDED|90.0|46.5|183.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||183.3|46.5|0.8322
73946267|NCT05436912|147425003|OTHER||Geometric Mean Ratio|169.6||||0.1131|TWO_SIDED|90.0|97.6|294.6|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||294.6|97.6|0.1131
73976252|NCT02298842|147497446|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|43.8|STANDARD_DEVIATION|26.05|||ONE_SIDED|97.5|36.821||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||36.821|
73946268|NCT04750655|147425065|OTHER|||||||1|||||||Kruskal-Wallis|||Used the Kruskal-Wallis (nonparametric one-way ANOVA), comparing all 3 arms. Note that for each individual, a single number (normalized read) is obtained.||||1
73946269|NCT01987817|147425091|SUPERIORITY||Risk Difference (RD)|60.0|||<|0.0001|TWO_SIDED|95.0|35.0|79.0|||Fisher Exact|||||79|35|<0.0001
73946270|NCT01987817|147425092|SUPERIORITY||Treatment difference|0.912|||<|0.0001|TWO_SIDED|95.0|0.5184|1.3065||The p-value is based on the F-test for treatment effect adjusted for MTD from baseline (log10 mg). The p-value and confidence intervals are based on the normality assumption.|ANCOVA|Least squares means and 95% CIs based on ANCOVA model of change from baseline in MTD at Exit DBPCFC (terms for treatment \& MTD at baseline (log10 mg).||MTD for the baseline and Exit DBPCFC are transformed back to log10 scale before calculations. A value of 0.3 mg is substituted for subjects who could not tolerate the lowest DBPCFC dose before log10 transformation.||1.3065|0.5184|<0.0001
74009042|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|12.212||0.833|TWO_SIDED|80.0|-18.67|13.45|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||13.45|-18.67|0.833
74009043|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|12.365||0.565|TWO_SIDED|80.0|-23.47|9.05|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.05|-23.47|0.565
74009044|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.75|STANDARD_ERROR_OF_MEAN|9.713||0.703|TWO_SIDED|80.0|-16.52|9.02|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.02|-16.52|0.703
74009045|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.46|STANDARD_ERROR_OF_MEAN|8.827||0.008|TWO_SIDED|80.0|-37.07|-13.85|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-13.85|-37.07|0.008
74009046|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|9.061||0.253|TWO_SIDED|80.0|-22.51|1.32|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.32|-22.51|0.253
74009047|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.47|STANDARD_ERROR_OF_MEAN|9.198||0.128|TWO_SIDED|80.0|-26.57|-2.38|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-2.38|-26.57|0.128
74009048|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.15|STANDARD_ERROR_OF_MEAN|11.421||0.196|TWO_SIDED|80.0|-30.17|-0.13|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.13|-30.17|0.196
74009049|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.17|STANDARD_ERROR_OF_MEAN|10.393||0.012|TWO_SIDED|80.0|-41.84|-14.51|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-14.51|-41.84|0.012
74009050|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.48|STANDARD_ERROR_OF_MEAN|10.773||0.047|TWO_SIDED|80.0|-36.65|-8.32|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-8.32|-36.65|0.047
74009051|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.63|STANDARD_ERROR_OF_MEAN|11.837||0.023|TWO_SIDED|80.0|-44.19|-13.06|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-13.06|-44.19|0.023
73946271|NCT00682643|147425104|SUPERIORITY_OR_OTHER|||||||0.395||95.0||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square|||||||0.395
73946272|NCT00682643|147425105|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square|||||||0.342
73946273|NCT01353222|147425144|SUPERIORITY||Hazard Ratio (HR)|1.141||||0.6188|TWO_SIDED|95.0|0.679|1.918|||From a stratified log-rank test, stratif||Cox regression model with treatment as the independent variable, stratified by randomization strata. Hazard ratio with control as reference.|||1.918|0.679|0.6188
73946274|NCT01806584|147425168|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED|||||p-value based on log rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.138
73946275|NCT01806584|147425169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|TWO_SIDED|||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.312
73946276|NCT01806584|147425170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093|TWO_SIDED|||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.093
73946277|NCT01806584|147425171|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.23|||||TWO_SIDED|95.0|-0.942|1.402||||||||1.402|-0.942|
73946278|NCT04503096|147425189|OTHER|To monitor safety, paired t-tests were conducted to test for pre- to post-treatment differences in global cognition (i.e., MoCA z-scores).||||||0.725|||||||t-test, 2 sided|||||||0.725
73946279|NCT04503096|147425193|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in depression using HAM-D raw scores.||||||0.605|||||||t-test, 2 sided|||||||.605
74031860|NCT01109004|147616953|SUPERIORITY|||||||0.37||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.37
74031861|NCT01109004|147616953|SUPERIORITY|||||||0.27||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.27
73946280|NCT04503096|147425194|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in depression using GDS raw scores.||||||0.897|||||||t-test, 2 sided|||||||.897
73946281|NCT04503096|147425195|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in cognition using Fluid Cognition Composite Scores.|||||<|0.001|||||||t-test, 2 sided|||||||< .001
73946282|NCT01480596|147425196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|1.592||0.256|TWO_SIDED|95.0|-5.08|1.4|||Mixed Models Analysis||Standard error of mean is for adjusted difference.|||1.40|-5.08|0.256
73946283|NCT01480596|147425197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.082||95.0|0.87|19.02|||exact methods|||||19.02|0.87|0.082
73946284|NCT01480596|147425198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.827||95.0|0.05|4.35|||exact methods|||||4.35|0.05|0.827
73946285|NCT01480596|147425199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.184|TWO_SIDED|95.0|0.62|10.1|||Cochran-Mantel-Haenszel|||||10.10|0.62|0.184
73946286|NCT01480596|147425201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.228||0.175|TWO_SIDED|95.0|-4.2|0.8|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||0.80|-4.20|0.175
73946287|NCT01480596|147425201|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|1.267||0.31|TWO_SIDED|95.0|-3.89|1.28|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||1.28|-3.89|0.310
73946288|NCT01480596|147425201|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|1.272||0.081|TWO_SIDED|95.0|-4.88|0.3|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||0.30|-4.88|0.081
73946289|NCT01480596|147425202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.486||0.972|TWO_SIDED|95.0|-2.97|3.07|||Mixed Models Analysis||Standard error of mean is for adjusted difference.|||3.07|-2.97|0.972
73946290|NCT01480596|147425203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||1|TWO_SIDED|95.0|0.26|5.48|||exact methods|||||5.48|0.26|1.000
73946291|NCT01480596|147425204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.53|TWO_SIDED|95.0|0.03|2.89|||exact methods|||||2.89|0.03|0.530
73946292|NCT01480596|147425205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.175|TWO_SIDED|95.0|0.64|11.46|||Cochran-Mantel-Haenszel|||||11.46|0.64|0.175
73946293|NCT01480596|147425207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.245||0.423|TWO_SIDED|95.0|-3.56|1.53|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||1.53|-3.56|0.423
73946294|NCT01480596|147425207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|1.361||0.986|TWO_SIDED|95.0|-2.76|2.8|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||2.80|-2.76|0.986
73946295|NCT01480596|147425207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.43||0.848|TWO_SIDED|95.0|-3.21|2.65|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||2.65|-3.21|0.848
73946296|NCT01480596|147425213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.707||0.483|TWO_SIDED|95.0|-1.94|0.93|||Mixed Models Analysis||Statistical analysis is presented for Week 12. Standard error of mean is for adjusted mean difference.|||0.93|-1.94|0.483
73958121|NCT04059237|147451963|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<.001
73946297|NCT01480596|147425213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.844||0.711|TWO_SIDED|95.0|-2.03|1.4|||Mixed Models Analysis||Statistical analysis is presented for Week 24. Standard error of mean is for adjusted mean difference.|||1.40|-2.03|0.711
73946298|NCT01480596|147425214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.757||0.028|TWO_SIDED|95.0|-3.3|-0.2|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||-0.20|-3.30|0.028
73946299|NCT01480596|147425214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.887||0.756|TWO_SIDED|95.0|-2.1|1.55|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||1.55|-2.10|0.756
73946300|NCT01480596|147425214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.909||0.775|TWO_SIDED|95.0|-2.12|1.59|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||1.59|-2.12|0.775
73946301|NCT01453348|147425222|NON_INFERIORITY_OR_EQUIVALENCE|(GMC anti-HAV + MenACWY-CRM / GMC anti-HAV)|Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.6|1.32||The testing was done by assessing the confidence interval of the ratio|ANCOVA|The Analysis of variance (ANCOVA) model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity was that the lower-limit of the two-sided 95% Confidence Interval (CI) on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.||1.32|0.6|
73946302|NCT01453348|147425222|NON_INFERIORITY_OR_EQUIVALENCE|(GMC anti-HBsAg + MenACWY-CRM / GMC anti-HBsAg)|Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.59|2.37||The testing was done by assessing the confidence interval of the ratio|ANCOVA|The ANCOVA model included vaccines group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity was that the the lower-limit of the two-sided 95% CI on the ratio of ELISA GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.||2.37|0.59|
73946303|NCT01216163|147425237|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|17.68|||<|0.001|TWO_SIDED|95.0|13.08|22.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference(Ibuprofen sodium - placebo) and 95 percent(%) confidence interval(CI):based on LS means from Analysis of Variance(ANOVA).Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:Ibuprofen sodium(IBU Na) versus(vs) Placebo(PBO), IBU Na vs Acetaminophen(APAP), APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||22.27|13.08|<0.001
74009052|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|5.08|STANDARD_ERROR_OF_MEAN|13.576||0.711|TWO_SIDED|80.0|-12.77|22.93|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||22.93|-12.77|0.711
74009053|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|12.365||0.666|TWO_SIDED|80.0|-10.86|21.66|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||21.66|-10.86|0.666
74009054|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.05|STANDARD_ERROR_OF_MEAN|12.333||0.807|TWO_SIDED|80.0|-19.27|13.17|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||13.17|-19.27|0.807
74009055|NCT01301456|147568785|SUPERIORITY_OR_OTHER||LS Mean Difference|6.79|STANDARD_ERROR_OF_MEAN|12.877||0.603|TWO_SIDED|80.0|-10.15|23.72|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||23.72|-10.15|0.603
74009056|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.551||0.387|TWO_SIDED|80.0|-0.24|1.21|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.21|-0.24|0.387
74009057|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.501||0.309|TWO_SIDED|80.0|-0.14|1.18|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.18|-0.14|0.309
74009058|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.518||0.956|TWO_SIDED|80.0|-0.71|0.65|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.65|-0.71|0.956
74009059|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.542||0.089|TWO_SIDED|80.0|0.24|1.67|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.67|0.24|0.089
74009060|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.923||0.434|TWO_SIDED|80.0|-0.48|1.95|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.95|-0.48|0.434
74009061|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25|STANDARD_ERROR_OF_MEAN|0.841||0.15|TWO_SIDED|80.0|0.14|2.35|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.35|0.14|0.150
74009062|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.861||0.752|TWO_SIDED|80.0|-0.86|1.41|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.41|-0.86|0.752
74009063|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.888||0.492|TWO_SIDED|80.0|-0.55|1.79|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.79|-0.55|0.492
73976253|NCT02232737|147497498|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
73869983|NCT00620113|147283573|SUPERIORITY_OR_OTHER||Difference in LS Means|-5.61||||0.458|TWO_SIDED|95.0|-23.79|12.56||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||12.56|-23.79|0.458
73946304|NCT01216163|147425237|SUPERIORITY_OR_OTHER||LS mean difference|4.96||||0.01|TWO_SIDED|95.0|1.21|8.72||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium - Acetaminophen) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||8.72|1.21|0.010
73946305|NCT01216163|147425237|SUPERIORITY_OR_OTHER||LS mean difference|12.71|||<|0.001|TWO_SIDED|95.0|8.12|17.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Acetaminophen - Placebo) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||17.30|8.12|<0.001
73976254|NCT02232737|147497498|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.03 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-5.57|-9.51|<0.0001
73976255|NCT00786864|147497543|SUPERIORITY_OR_OTHER||||||p=|0||95.0|||||ANCOVA|||||||p=0.001
73869984|NCT01979133|147283587|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||.012
73946306|NCT01216163|147425238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.84|||<|0.001|TWO_SIDED|95.0|5.13|27.36||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||27.36|5.13|<0.001
73946307|NCT01216163|147425238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.468|TWO_SIDED|95.0|0.81|1.6||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||1.60|0.81|0.468
73946308|NCT01216163|147425238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|10.43|||<|0.001|TWO_SIDED|95.0|4.5|24.17||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||24.17|4.50|<0.001
73946309|NCT01216163|147425239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|14.06|||<|0.001|TWO_SIDED|95.0|6.02|32.8||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||32.80|6.02|<0.001
73946310|NCT01216163|147425239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.323|TWO_SIDED|95.0|0.84|1.68||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.68|0.84|0.323
73976256|NCT00786864|147497544|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.001
73976257|NCT00786864|147497545|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.001
73976258|NCT00786864|147497546|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.01
74009064|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.064||0.358|TWO_SIDED|80.0|-0.4|2.4|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.40|-0.40|0.358
73869985|NCT01979133|147283588|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.005
73869986|NCT01979133|147283589|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.017
73869987|NCT01979133|147283590|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.038
73869988|NCT01979133|147283591|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.034
73869989|NCT01979133|147283592|SUPERIORITY_OR_OTHER|||||||0.231|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.231
73869990|NCT01979133|147283593|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.066
73946311|NCT01216163|147425239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.81|||<|0.001|TWO_SIDED|95.0|5.06|27.59||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||27.59|5.06|<0.001
74031862|NCT01109004|147616954|SUPERIORITY|||||||0.92||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.92
73946312|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.53|||<|0.001|TWO_SIDED|95.0|0.24|0.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.83|0.24|<0.001
73946313|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.101|TWO_SIDED|95.0|-0.04|0.44||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.44|-0.04|0.101
73958122|NCT04059237|147451964|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<0.001
74031863|NCT01109004|147616954|SUPERIORITY|||||||0.21||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.21
74031864|NCT01109004|147616954|SUPERIORITY|||||||0.22||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.22
73869991|NCT00486824|147283594|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
73869992|NCT00826618|147283695|SUPERIORITY_OR_OTHER|||||||0.0015|||||||t-test, 2 sided|||Compare final visual acuity to baseline visual acuity||||0.0015
73869993|NCT00303485|147283742|SUPERIORITY_OR_OTHER||Difference in median|-64.2|||<|0.0001|TWO_SIDED|95.0|-80.28|-46.21|||Wilcoxon rank sum test|||||-46.21|-80.28|< 0.0001
73869994|NCT03928717|147283752|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73869995|NCT03928717|147283753|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73869996|NCT04120402|147283754|SUPERIORITY|||||||0.004|||||||ANCOVA|||||||0.004
73869997|NCT04120402|147283755|SUPERIORITY|||||||0.014|||||||ANCOVA|||||||0.014
73869998|NCT04120402|147283756|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73869999|NCT04120402|147283757|SUPERIORITY|||||||0.518|||||||ANCOVA|||||||0.518
73870000|NCT04120402|147283758|SUPERIORITY|||||||0.028|||||||Fisher Exact|||||||0.028
73870001|NCT02219334|147283762|EQUIVALENCE|Historical data at the institution for similar patients had a mean length of stay(LOS) of 25.7 hours (standard deviation-\[SD\] =10.3) from 9/2012- 9/13 was observed for 134 patients admitted to the emergency department observation unit and treated with the standard of care (NeoSucker). Given a LOS-SD of 10.3 hours, 75 subjects per treatment group would provide 80% statistical power at the 5% significance level to demonstrate equivalence in the two treatments' length of stay within ±5 hours.|Mean Difference (Final Values)|2.49|STANDARD_DEVIATION|21.4|<|0.05|TWO_SIDED|95.0|-10.74|15.72|||two one-sided t-test (TOST)||Due to slower than anticipated patient recruitment, the target size of 75 participants per treatment group was not reached.|The primary hypothesis of length of stay equivalence within a margin of ± 5 hours was tested using the two one-sided t-test (TOST) procedure, with a 5% significance level.||15.72|-10.74|<0.05
73870002|NCT05173012|147283830|SUPERIORITY||Least Squares (LS) Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.623||0.5325|TWO_SIDED|95.0|-0.84|1.62|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 15 mg - placebo.|||1.62|-0.84|0.5325
73958123|NCT04059237|147451965|OTHER|||||||0.1||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.10
73958124|NCT04059237|147451966|OTHER|||||||0.01||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||.01
73958125|NCT04059237|147451967|OTHER|||||||0.59||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.59
73958126|NCT04059237|147451968|OTHER|||||||0.02||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.02
73958127|NCT04059237|147451969|OTHER|||||||0.52||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.52
73958128|NCT04059237|147451970|OTHER|||||||0.08||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.08
73958129|NCT01245439|147452000|SUPERIORITY_OR_OTHER|||||||0.929|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.929
73958130|NCT01245439|147452000|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to 3||||<0.001
73958131|NCT01245439|147452000|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||<0.001
73958132|NCT01245439|147452000|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.050
73958133|NCT01245439|147452000|SUPERIORITY_OR_OTHER|||||||0.165|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.165
73870003|NCT05173012|147283830|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.634||0.6549|TWO_SIDED|95.0|-1.54|0.97|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 30 mg - placebo.|||0.97|-1.54|0.6549
73946314|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.029|TWO_SIDED|95.0|0.03|0.62||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.62|0.03|0.029
73946315|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|1.44|||<|0.001|TWO_SIDED|95.0|1.01|1.87||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.87|1.01|<0.001
73946316|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.24||||0.178|TWO_SIDED|95.0|-0.11|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.11|0.178
73946317|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.77|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.63|0.77|<0.001
73946318|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|2.07|||<|0.001|TWO_SIDED|95.0|1.64|2.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.49|1.64|<0.001
73946319|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.44||||0.014|TWO_SIDED|95.0|0.09|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.78|0.09|0.014
73946320|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.21|2.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.06|1.21|<0.001
73958134|NCT01245439|147452000|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.133
73958135|NCT01245439|147452000|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.217
73958136|NCT01245439|147452000|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8||||<0.001
74031865|NCT01109004|147616955|SUPERIORITY|||||||0.26||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.26
73870004|NCT05173012|147283830|SUPERIORITY||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.7||0.1462|TWO_SIDED|95.0|-0.36|2.41|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 60 mg - placebo.|||2.41|-0.36|0.1462
73870005|NCT05173012|147283831|SUPERIORITY||LS Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|1.326||0.1271|TWO_SIDED|95.0|0.59|4.67|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||4.67|0.59|0.1271
73958137|NCT01245439|147452003|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.169
73958138|NCT01245439|147452003|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3||||<0.001
73958139|NCT01245439|147452003|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||0.053
73958140|NCT01245439|147452003|SUPERIORITY_OR_OTHER|||||||0.514|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.514
73958141|NCT01245439|147452003|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.064
73958142|NCT01245439|147452003|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.038
73958143|NCT01245439|147452003|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.064
73958144|NCT01245439|147452003|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8||||<0.001
73958145|NCT01245439|147452004|SUPERIORITY_OR_OTHER|||||||0.981|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.981
73958146|NCT01245439|147452004|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3||||<0.001
73958147|NCT01245439|147452004|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||0.005
73958148|NCT01245439|147452004|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.566
73958149|NCT01245439|147452004|SUPERIORITY_OR_OTHER|||||||0.264|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.264
73958150|NCT01245439|147452004|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.126
73958151|NCT01245439|147452004|SUPERIORITY_OR_OTHER|||||||0.779|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.779
74031866|NCT01109004|147616955|SUPERIORITY|||||||0.53||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.53
74031867|NCT01109004|147616955|SUPERIORITY|||||||0.57||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.57
74031868|NCT01109004|147616956|SUPERIORITY|||||||0.63||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.63
74031869|NCT01109004|147616956|SUPERIORITY|||||||0.15||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.15
74031870|NCT01109004|147616956|SUPERIORITY|||||||0.33||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.33
74031871|NCT02410902|147616977|OTHER|ANCOVA using MMRM analysis|Mean Difference (Final Values)|-2.56||||0.038|TWO_SIDED|95.0|-4.98|-0.14|||ANCOVA|||||-0.14|-4.98|0.038
74031872|NCT02410902|147616978|OTHER|ANCOVA using MMRM analysis|Mean Difference (Final Values)|-1.07||||0.325|TWO_SIDED|95.0|-3.21|1.07|||ANCOVA|||||1.07|-3.21|0.325
74031873|NCT00137436|147616999|SUPERIORITY_OR_OTHER|||||||0.942||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.942
74031874|NCT00137436|147616999|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.323
73946321|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|2.25|||<|0.001|TWO_SIDED|95.0|1.79|2.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.70|1.79|<0.001
73946322|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.055|TWO_SIDED|95.0|-0.01|0.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.74|-0.01|0.055
73946323|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.43|2.34||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.34|1.43|<0.001
73946324|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|2.31|||<|0.001|TWO_SIDED|95.0|1.8|2.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.83|1.80|<0.001
74031875|NCT00137436|147616999|SUPERIORITY_OR_OTHER|||||||0.865||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.865
74031876|NCT00137436|147616999|SUPERIORITY_OR_OTHER|||||||0.873||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.873
74031877|NCT00137436|147617000|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.736
74031878|NCT00137436|147617000|SUPERIORITY_OR_OTHER|||||||0.962||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.962
74031879|NCT00137436|147617000|SUPERIORITY_OR_OTHER|||||||0.185||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.185
73946325|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.51||||0.019|TWO_SIDED|95.0|0.08|0.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.93|0.08|0.019
73946326|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|1.81|||<|0.001|TWO_SIDED|95.0|1.29|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.32|1.29|<0.001
73946327|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.66|1.53|<0.001
73958152|NCT01245439|147452004|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||||||<0.001
74031880|NCT00137436|147617000|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||1.000
74031881|NCT00137436|147617001|SUPERIORITY_OR_OTHER|||||||0.386||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.386
74031882|NCT00137436|147617001|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.904
74031883|NCT00137436|147617001|SUPERIORITY_OR_OTHER|||||||0.812||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.812
74031884|NCT00137436|147617001|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.490
74031885|NCT00137436|147617002|SUPERIORITY_OR_OTHER|||||||0.839||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.839
74031886|NCT00137436|147617002|SUPERIORITY_OR_OTHER|||||||0.219||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.219
74031887|NCT00137436|147617002|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.788
73870006|NCT05173012|147283831|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.347||0.5642|TWO_SIDED|95.0|-3.45|1.89|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||1.89|-3.45|0.5642
73870007|NCT05173012|147283831|SUPERIORITY||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|1.439||0.486|TWO_SIDED|95.0|-1.84|3.85|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||3.85|-1.84|0.4860
73870008|NCT02936843|147283834|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|2-sided||TTEST, two sided||||0.41
73870009|NCT03668613|147283849|SUPERIORITY||Predicted Log-OR|4.862|||||TWO_SIDED|95.0|3.422|6.782|||Bayesian method using (MAP)|||Compared to historical placebo||6.782|3.422|
73946328|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.59||||0.013|TWO_SIDED|95.0|0.13|1.05||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.05|0.13|0.013
73946329|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|1.51|||<|0.001|TWO_SIDED|95.0|0.95|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.07|0.95|<0.001
73946330|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|1.97|||<|0.001|TWO_SIDED|95.0|1.39|2.56||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.56|1.39|<0.001
73946331|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.63||||0.01|TWO_SIDED|95.0|0.15|1.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.10|0.15|0.010
73946332|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|1.35|||<|0.001|TWO_SIDED|95.0|0.77|1.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.93|0.77|<0.001
73946333|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|1.54|||<|0.001|TWO_SIDED|95.0|0.95|2.14||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.14|0.95|<0.001
73946334|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.42||||0.088|TWO_SIDED|95.0|-0.06|0.91||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.91|-0.06|0.088
74031888|NCT00137436|147617002|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.164
73870010|NCT03668613|147283849|SUPERIORITY||Predicted log-OR|4.836|||||TWO_SIDED|95.0|3.422|6.772|||Bayesian method using (MAP)|||Compared to historical placebo||6.772|3.422|
73870011|NCT03668613|147283850|SUPERIORITY||Predicted log -OR|4.292|||||TWO_SIDED|95.0|2.638|6.513|||Bayesian method using (MAP)|||Compared to historical placebo||6.513|2.638|
73870012|NCT03668613|147283850|SUPERIORITY||Predicted log-OR|4.606|||||TWO_SIDED|95.0|2.919|6.78|||Bayesian method using (MAP)|||Compared to historical placebo||6.780|2.919|
73870013|NCT03668613|147283851|SUPERIORITY||Predicted log-OR|4.367|||||TWO_SIDED|95.0|2.916|6.202|||Bayesian method using (MAP)|||||6.202|2.916|
73870014|NCT03668613|147283851|SUPERIORITY||Predicted log-OR|4.709|||||TWO_SIDED|95.0|3.201|6.58|||Bayesian method using (MAP)|||||6.580|3.201|
73870015|NCT01393821|147283854|SUPERIORITY|||||||0.6311|||||||Kruskal-Wallis|||||||0.6311
73870016|NCT02920749|147283892|SUPERIORITY_OR_OTHER||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.||||<0.05
73870017|NCT02920749|147283893|SUPERIORITY_OR_OTHER||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.||||<0.05
73870018|NCT03781414|147283894|NON_INFERIORITY|The primary objective would be demonstrated, if the composite efficacy failure rate difference between any of the two CFZ533 arms and the TAC arm is less than the pre-defined non-inferiority margin (0.15) with probability \>80%.|Rate difference|0.0759|||||TWO_SIDED|95.0|-0.0729|0.2165||||||||0.2165|-0.0729|
73870019|NCT03781414|147283894|NON_INFERIORITY|The primary objective would be demonstrated, if the composite efficacy failure rate difference between any of the two CFZ533 arms and the TAC arm is less than the pre-defined non-inferiority margin (0.15) with probability \>80%.|Rate difference|0.1696|||||TWO_SIDED|95.0|0.0072|0.3276||||||||0.3276|0.0072|
73870020|NCT00719355|147283923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.25|STANDARD_DEVIATION|14.4||0.033|TWO_SIDED|95.0||||A priori level of significance was set at p \<0.05.|ANCOVA|Repeated-measures ANCOVA using intent-to-treat procedures, was used for the primary outcome variable. Analyses were adjusted for age.||Observed power for our primary analysis was 0.64.||||0.033
74031889|NCT00137436|147617003|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.656
74031890|NCT00137436|147617003|SUPERIORITY_OR_OTHER|||||||0.628||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.628
74089259|NCT02697773|147731609|SUPERIORITY||Least Square Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07||0.0007|TWO_SIDED|95.0|-0.4|-0.11|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.11|-0.40|0.0007
74089260|NCT02697773|147731609|SUPERIORITY||Least Mean Square Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.36|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.07|-0.36|0.0040
73946335|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||<|0.001|TWO_SIDED|95.0|0.52|1.71||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.71|0.52|<0.001
73946336|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||<|0.001|TWO_SIDED|95.0|0.85|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.07|0.85|<0.001
73946337|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.47||||0.061|TWO_SIDED|95.0|-0.02|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.97|-0.02|0.061
73946338|NCT01216163|147425240|SUPERIORITY_OR_OTHER||LS mean difference|0.98||||0.002|TWO_SIDED|95.0|0.38|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.38|0.002
73870021|NCT00719355|147283924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|3.65||0.109||95.0|||||ANCOVA|Repeated measures ANCOVA was used with intent to treat analysis. The co-variant was age.||||||0.109
73870022|NCT01835158|147283925|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.012|TWO_SIDED|95.0|0.46|0.95|||Log Rank|||||.95|.46|0.012
73870023|NCT01835158|147283926|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.26||||||||1.26|0.50|
73958153|NCT01245439|147452005|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints Visit 1 to Visit 2||||0.410
73958154|NCT01245439|147452005|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 3||||<0.001
73958155|NCT01245439|147452005|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 3 to Visit 4||||<0.001
73958156|NCT01245439|147452005|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 4 to Visit 5||||0.021
73958157|NCT01245439|147452005|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 5 to Visit 6||||0.003
73958158|NCT01245439|147452005|SUPERIORITY_OR_OTHER|||||||0.827|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 6 to Visit7||||0.827
73958159|NCT01245439|147452005|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 7 to Visit 8||||0.093
73958160|NCT01245439|147452005|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 8||||<0.001
73958161|NCT01245439|147452005|SUPERIORITY_OR_OTHER|||||||0.792|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 1 to Visit 2||||0.792
73958162|NCT01245439|147452005|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 3||||<0.001
73958163|NCT01245439|147452005|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 3 to Visit 4||||0.002
73958164|NCT01245439|147452005|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 4 to Visit 5||||0.374
73958165|NCT01245439|147452005|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 5 to Visit 6||||0.518
73958166|NCT01245439|147452005|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 6 to Visit 7||||0.744
73958167|NCT01245439|147452005|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 7 to Visit 8||||0.048
73958168|NCT01245439|147452005|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 8||||<0.001
73958169|NCT01245439|147452006|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 3||||<0.001
73958170|NCT01245439|147452006|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 3 to Visit 4||||<0.001
73958171|NCT01245439|147452006|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 4 to Visit 5||||0.075
73958172|NCT01245439|147452006|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 5 to Visit 6||||0.119
73958173|NCT01245439|147452006|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 6 to Visit 7||||0.007
73958174|NCT01245439|147452006|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 7 to Visit 8||||0.047
73958175|NCT01245439|147452006|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 8||||<0.001
73946339|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.31|||<|0.001|TWO_SIDED|95.0|0.13|0.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.49|0.13|<0.001
74031891|NCT00137436|147617003|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.420
73946340|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.06||||0.387|TWO_SIDED|95.0|-0.08|0.21||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.21|-0.08|0.387
73946341|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.007|TWO_SIDED|95.0|0.07|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.42|0.07|0.007
73946342|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.89|||<|0.001|TWO_SIDED|95.0|0.64|1.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.15|0.64|<0.001
73946343|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.019|TWO_SIDED|95.0|0.04|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.04|0.019
73946344|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.64|||<|0.001|TWO_SIDED|95.0|0.38|0.9||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.90|0.38|<0.001
73946345|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||<|0.001|TWO_SIDED|95.0|1.01|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|1.01|<0.001
73946346|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.006|TWO_SIDED|95.0|0.09|0.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.57|0.09|0.006
73946347|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.97|||<|0.001|TWO_SIDED|95.0|0.68|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.26|0.68|<0.001
73946348|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|1.43|||<|0.001|TWO_SIDED|95.0|1.12|1.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.74|1.12|<0.001
74031892|NCT00137436|147617003|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.296
74031893|NCT00137436|147617004|SUPERIORITY_OR_OTHER|||||||0.903||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.903
74031894|NCT00137436|147617004|SUPERIORITY_OR_OTHER|||||||0.434||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.434
74031895|NCT00137436|147617004|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.687
74031896|NCT00137436|147617004|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.296
74031897|NCT04657016|147617009|SUPERIORITY||Mean Difference (Net)|-24.5|||<|0.001|TWO_SIDED|95.0|-26.1|-22.8|||Mixed Models Analysis|||||-22.8|-26.1|<0.001
74031898|NCT04657016|147617010|SUPERIORITY||Odds Ratio (OR)|130.36|||<|0.001|TWO_SIDED|95.0|69.98|242.84|||Regression, Logistic|||||242.84|69.98|<0.001
73958176|NCT01245439|147452006|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 3||||<0.001
73958177|NCT01245439|147452006|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 3 to Visit 4||||<0.001
73958178|NCT01245439|147452006|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 4 to Visit 5||||0.001
73958179|NCT01245439|147452006|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 5 to Visit 6||||0.084
73958180|NCT01245439|147452006|SUPERIORITY_OR_OTHER|||||||0.272|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 6 to Visit 7||||0.272
73958181|NCT01245439|147452006|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 7 to Visit 8||||0.020
73958182|NCT01245439|147452006|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 8||||<0.001
73958183|NCT01245439|147452007|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3||||<0.001
73958184|NCT01245439|147452007|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4||||<0.001
73958185|NCT01245439|147452007|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5||||0.254
74031899|NCT04657016|147617011|SUPERIORITY||Odds Ratio (OR)|101.6|||<|0.001|TWO_SIDED|95.0|39.17|263.55|||Regression, Logistic|||||263.55|39.17|<0.001
73946349|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.32||||0.014|TWO_SIDED|95.0|0.07|0.58||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.58|0.07|0.014
73870024|NCT02932748|147283964|SUPERIORITY||||||<|0.0001||||||A global one-way ANOVA was followed by two pairwise t-tests on the comparisons of interest, i.e., IP vs. EUC, and GP vs IP for weight change across 6 months, evaluated at p ≤ 0.025, using both intent-to-treat and completer only data.|ANOVA|||||||<.0001
73946350|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|1.11|||<|0.001|TWO_SIDED|95.0|0.8|1.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.42|0.80|<0.001
73946351|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|1.43|||<|0.001|TWO_SIDED|95.0|1.09|1.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.78|1.09|<0.001
73946352|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.31||||0.03|TWO_SIDED|95.0|0.03|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|0.03|0.030
73946353|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||<|0.001|TWO_SIDED|95.0|0.78|1.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.46|0.78|<0.001
73946354|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|1.29|||<|0.001|TWO_SIDED|95.0|0.91|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.66|0.91|<0.001
73946355|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.42||||0.007|TWO_SIDED|95.0|0.12|0.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.73|0.12|0.007
73946356|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.87|||<|0.001|TWO_SIDED|95.0|0.49|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.24|0.49|<0.001
73946357|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|1.27|||<|0.001|TWO_SIDED|95.0|0.89|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.65|0.89|<0.001
73976259|NCT04162210|147497583|OTHER||Stratified Hazard Ratio (HR)|1.03||||0.558|TWO_SIDED|95.0|0.72|1.47|||Log Rank|One-sided p-value from stratified log-rank test were adjusted for previous treatment with anti-CD38, ISS staging and number of prior lines of therapy.|HR was estimated using the Cox Proportional Hazards. HR stratified log-rank test were adjusted for previous treatment with anti-CD38, international staging system (ISS) staging and number of prior lines of therapy.|||1.47|0.72|0.558
73976260|NCT01767467|147497670|NON_INFERIORITY|The objective was met if the lower limit of the 95% CI of the Geometric Mean (GM) ratio (GSK1437173A vaccine over placebo) for anti-gE ELISA antibody concentrations at Month 2 was greater than (\>) 3.|Adjusted Geometric Mean Concentration|29.75|||<|0.0001|TWO_SIDED|95.0|21.09|41.96||The p-value is relative to the null hypothesis Ho: Vaccine / Placebo = 1|Repeated measurement model|||The objective aimed to evaluate anti-gE humoral immune responses at Month 2 following a two-dose administration of the GSK1437173A vaccine, as compared to placebo, in subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.||41.96|21.09|<0.0001
73976261|NCT00291694|147497731|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
73976262|NCT00291694|147497732|SUPERIORITY_OR_OTHER|||||||0.053||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Difference between groups, two-sided. Endpoint not specifically powered for effect.||||0.053
73976263|NCT00291694|147497733|SUPERIORITY_OR_OTHER|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.37
74031900|NCT04657016|147617012|SUPERIORITY||Odds Ratio (OR)|153.95|||<|0.001|TWO_SIDED|95.0|78.9|300.37|||Regression, Logistic|||||300.37|78.90|<0.001
73946358|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.004|TWO_SIDED|95.0|0.15|0.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.76|0.15|0.004
73976264|NCT00291694|147497734|SUPERIORITY_OR_OTHER|||||||0.39||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.39
73976265|NCT00291694|147497735|SUPERIORITY_OR_OTHER|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.37
74031901|NCT04657016|147617013|SUPERIORITY||Odds Ratio (OR)|144.48|||<|0.001|TWO_SIDED|95.0|62.65|333.21|||Regression, Logistic|||||333.21|62.65|<0.001
74031902|NCT04657016|147617014|SUPERIORITY||Odds Ratio (OR)|118.06|||<|0.001|TWO_SIDED|95.0|40.08|347.74|||Regression, Logistic|||||347.74|40.08|<0.001
73946359|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.44|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.19|0.44|<0.001
73946360|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.92|||<|0.001|TWO_SIDED|95.0|0.54|1.31||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.31|0.54|<0.001
73946361|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.28||||0.084|TWO_SIDED|95.0|-0.04|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.04|0.084
73946362|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.65||||0.001|TWO_SIDED|95.0|0.27|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.03|0.27|0.001
73946363|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.54|1.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.32|0.54|<0.001
73946364|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.38||||0.02|TWO_SIDED|95.0|0.06|0.69||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|0.06|0.020
73946365|NCT01216163|147425241|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.005|TWO_SIDED|95.0|0.17|0.94||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.94|0.17|0.005
74031903|NCT04657016|147617015|SUPERIORITY||Mean Difference (Net)|-17.9|||<|0.001|TWO_SIDED|95.0|-19.5|-16.3|||Mixed Models Analysis|||||-16.3|-19.5|<0.001
74031904|NCT04657016|147617016|SUPERIORITY||Mean Difference (Net)|-25.0|||<|0.001|TWO_SIDED|95.0|-26.9|-23.2|||Mixed Models Analysis|||||-23.2|-26.9|<0.001
73946366|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|0.84|||<|0.001|TWO_SIDED|95.0|0.4|1.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.28|0.40|<0.001
73946367|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|0.27||||0.148|TWO_SIDED|95.0|-0.1|0.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.63|-0.10|0.148
73946368|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|0.57||||0.011|TWO_SIDED|95.0|0.13|1.02||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.02|0.13|0.011
73946369|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|2.34|||<|0.001|TWO_SIDED|95.0|1.68|2.99||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.99|1.68|<0.001
73946370|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.071|TWO_SIDED|95.0|-0.04|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.03|-0.04|0.071
73946371|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|1.84|||<|0.001|TWO_SIDED|95.0|1.19|2.5||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.50|1.19|<0.001
73958186|NCT01245439|147452007|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6||||0.138
73958187|NCT01245439|147452007|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7||||0.002
73958188|NCT01245439|147452007|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8||||0.104
73958189|NCT01245439|147452007|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 8||||<0.001
73958190|NCT01245439|147452008|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3||||<0.001
73958191|NCT01245439|147452008|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4||||0.002
73958192|NCT01245439|147452008|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5||||0.078
73946372|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|3.37|||<|0.001|TWO_SIDED|95.0|2.67|4.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.06|2.67|<0.001
73946373|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|0.77||||0.008|TWO_SIDED|95.0|0.2|1.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.33|0.20|0.008
73946374|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||<|0.001|TWO_SIDED|95.0|1.91|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.30|1.91|<0.001
73946375|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||<|0.001|TWO_SIDED|95.0|2.92|4.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.43|2.92|<0.001
73946376|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|0.69||||0.028|TWO_SIDED|95.0|0.07|1.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.30|0.07|0.028
73946377|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.24|3.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.74|2.24|<0.001
73958193|NCT01245439|147452008|SUPERIORITY_OR_OTHER|||||||0.349|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6||||0.349
73958194|NCT01245439|147452008|SUPERIORITY_OR_OTHER|||||||0.722|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7||||0.722
73958195|NCT01245439|147452008|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8||||0.224
73958196|NCT05046132|147452009|OTHER||Mean of Placebo-corrected CHFB|3.7|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|1.23|6.17||||||"The C-QTc analysis was performed with a non-linear model.~The mean of placebo-corrected CHFB in QTcF at maximum concentration (Cmax) geometric mean of therapeutic dose (3 mg QD) was estimated with bias-corrected 90% CI by nonparametric bootstrap methods."||6.17|1.23|
73958197|NCT05046132|147452010|OTHER||Mean of Placebo-corrected CHFB|4.67|||||TWO_SIDED|90.0|1.7|7.64||||||The C-QTc analysis was performed with a non-linear model. The mean of placebo-corrected CHFB in QTcF at Cmax geometric mean of therapeutic dose (7 mg QD) was estimated with bias-corrected 90% CI by nonparametric bootstrap methods.||7.64|1.70|
73958198|NCT05046132|147452011|OTHER||LS Mean|2.5|||||TWO_SIDED|90.0|-0.6|5.6||||||Pre-dose||5.6|-0.6|
73958199|NCT05046132|147452011|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-3.0|3.1||||||0.5 hr Post dose||3.1|-3.0|
73958200|NCT05046132|147452011|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.8|3.0||||||1 hr Post dose||3.0|-2.8|
73958201|NCT05046132|147452011|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.8|5.1||||||1.5 hr Post dose||5.1|-1.8|
73958202|NCT05046132|147452011|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.8|4.1||||||2 hr Post dose||4.1|-2.8|
73958203|NCT05046132|147452011|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.9|3.4||||||2.5 hr Post dose||3.4|-2.9|
73958204|NCT05046132|147452011|OTHER||LS Mean|2.2|||||TWO_SIDED|90.0|-1.4|5.7||||||3 hr Post dose||5.7|-1.4|
73958205|NCT05046132|147452011|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-2.9|2.7||||||4 hr Post dose||2.7|-2.9|
73958206|NCT05046132|147452011|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.1|2.7||||||5 hr Post dose||2.7|-3.1|
73958207|NCT05046132|147452011|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-3.8|2.3||||||6 hr Post dose||2.3|-3.8|
73958208|NCT05046132|147452011|OTHER||LS Mean|-2.8|||||TWO_SIDED|90.0|-5.5|-0.1||||||7 hr Post dose||-0.1|-5.5|
73958209|NCT05046132|147452011|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.5|1.3||||||8 hr Post dose||1.3|-4.5|
73958210|NCT05046132|147452011|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.5|3.0||||||9 hr Post dose||3.0|-2.5|
73958211|NCT05046132|147452011|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.3|2.7||||||10 hr Post dose||2.7|-2.3|
73958212|NCT05046132|147452011|OTHER||LS Mean|-3.0|||||TWO_SIDED|90.0|-5.9|-0.1||||||12 hr Post dose||-0.1|-5.9|
73958213|NCT05046132|147452011|OTHER||LS Mean|-2.0|||||TWO_SIDED|90.0|-5.1|1.0||||||16 hr Post dose||1.0|-5.1|
73958214|NCT05046132|147452011|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-1.6|3.8||||||24 hr Post dose||3.8|-1.6|
73958215|NCT05046132|147452011|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-1.7|4.5||||||Pre-dose||4.5|-1.7|
73958216|NCT05046132|147452011|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.4|4.7||||||0.5 hr Post dose||4.7|-1.4|
73958217|NCT05046132|147452011|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.0|4.8||||||1 hr Post dose||4.8|-1.0|
73958218|NCT05046132|147452011|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-0.9|6.0||||||1.5 hr Post dose||6.0|-0.9|
73958219|NCT05046132|147452011|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-2.1|4.8||||||2 hr Post dose||4.8|-2.1|
73958220|NCT05046132|147452011|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.4|4.9||||||2.5 hr Post dose||4.9|-1.4|
73958221|NCT05046132|147452011|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.9|5.1||||||3 hr Post dose||5.1|-1.9|
73958222|NCT05046132|147452011|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-1.4|4.2||||||4 hr Post dose||4.2|-1.4|
73958223|NCT05046132|147452011|OTHER||LS Mean|2.7|||||TWO_SIDED|90.0|-0.2|5.7||||||5 hr Post dose||5.7|-0.2|
73958224|NCT05046132|147452011|OTHER||LS Mean|4.4|||||TWO_SIDED|90.0|1.4|7.5||||||6 hr Post dose||7.5|1.4|
73958225|NCT05046132|147452011|OTHER||LS Mean|2.8|||||TWO_SIDED|90.0|0.1|5.5||||||7 hr Post dose||5.5|0.1|
74031905|NCT04657016|147617017|SUPERIORITY||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-9.6|-8.3|||Mixed Models Analysis|||||-8.3|-9.6|<0.001
73870025|NCT00475904|147283984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.547|STANDARD_ERROR_OF_MEAN|0.2709||0.0441|TWO_SIDED|95.0|0.01|1.08||a priori threshold for statistical significance was p\<0.05|ANOVA|||In the initial analysis, the efficacy of the test treatment NP-1 cream was compared with placebo using an analysis of variance (ANOVA). The analysis was conducted using the ITT population to compare the mean changes in pain scores from baseline to endpoint for the 2 treatments; the LOCF approach was employed for patients who did not complete the trial.||1.08|0.01|0.0441
73946378|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|3.75|||<|0.001|TWO_SIDED|95.0|2.9|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.59|2.90|<0.001
73946379|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|0.82||||0.02|TWO_SIDED|95.0|0.13|1.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.51|0.13|0.020
73946380|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|2.93|||<|0.001|TWO_SIDED|95.0|2.09|3.77||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.77|2.09|<0.001
73946381|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|3.38|||<|0.001|TWO_SIDED|95.0|2.46|4.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.30|2.46|<0.001
73946382|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|1.01||||0.009|TWO_SIDED|95.0|0.26|1.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.76|0.26|0.009
73946383|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||<|0.001|TWO_SIDED|95.0|1.46|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.30|1.46|<0.001
73946384|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|3.24|||<|0.001|TWO_SIDED|95.0|2.3|4.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.19|2.30|<0.001
73946385|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|1.08||||0.006|TWO_SIDED|95.0|0.31|1.85||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.85|0.31|0.006
73946386|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|2.16|||<|0.001|TWO_SIDED|95.0|1.22|3.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.10|1.22|<0.001
73946387|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|2.47|||<|0.001|TWO_SIDED|95.0|1.51|3.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.43|1.51|<0.001
74031906|NCT04657016|147617018|SUPERIORITY||Mean Difference (Net)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.2|-8.1|||Mixed Models Analysis|||||-8.1|-12.2|<0.001
74031907|NCT04657016|147617019|SUPERIORITY||Mean Difference (Net)|-5.7|||<|0.001|TWO_SIDED|95.0|-7.2|-4.3|||Mixed Models Analysis|||||-4.3|-7.2|<0.001
73946388|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|0.7||||0.08|TWO_SIDED|95.0|-0.09|1.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.49|-0.09|0.080
73958226|NCT05046132|147452011|OTHER||LS Mean|4.1|||||TWO_SIDED|90.0|1.2|7.0||||||8 hr Post dose||7.0|1.2|
73958227|NCT05046132|147452011|OTHER||LS Mean|3.6|||||TWO_SIDED|90.0|0.8|6.3||||||9 hr Post dose||6.3|0.8|
73958228|NCT05046132|147452011|OTHER||LS Mean|3.3|||||TWO_SIDED|90.0|0.8|5.8||||||10 hr Post dose||5.8|0.8|
73958229|NCT05046132|147452011|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-0.3|5.5||||||12 hr Post dose||5.5|-0.3|
73958230|NCT05046132|147452011|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.7|3.4||||||16 hr Post dose||3.4|-2.7|
73958231|NCT05046132|147452011|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.0|4.4||||||24 hr Post dose||4.4|-1.0|
73958232|NCT05046132|147452012|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.8|3.4||||||Pre dose||3.4|-2.8|
73958233|NCT05046132|147452012|OTHER||LS Mean|-2.1|||||TWO_SIDED|90.0|-5.3|1.0||||||0.5 hr Post dose||1.0|-5.3|
73958234|NCT05046132|147452012|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.7|1.4||||||1 hr Post dose||1.4|-4.7|
73958235|NCT05046132|147452012|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.3|1.0||||||1.5 hr Post dose||1.0|-5.3|
74031908|NCT04657016|147617020|SUPERIORITY||Mean Difference (Net)|-7.79|STANDARD_ERROR_OF_MEAN|1.348|<|0.001|TWO_SIDED|95.0|-10.4|-5.1|||Mixed Models Analysis|||||-5.10|-10.40|<0.001
74031909|NCT04657016|147617021|SUPERIORITY||Mean Difference (Net)|11.4|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|8.2|14.7|||Mixed Models Analysis|||||14.7|8.2|<0.001
73946389|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|1.77|||<|0.001|TWO_SIDED|95.0|0.81|2.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.73|0.81|<0.001
73946390|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|1.41|3.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.37|1.41|<0.001
73946391|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|0.85||||0.037|TWO_SIDED|95.0|0.05|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.65|0.05|0.037
73946392|NCT01216163|147425242|SUPERIORITY_OR_OTHER||LS mean difference|1.54||||0.002|TWO_SIDED|95.0|0.57|2.52||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.52|0.57|0.002
73946393|NCT01216163|147425243|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||<|0.001|TWO_SIDED|95.0|1.88|2.88||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.88|1.88|<0.001
73946394|NCT01216163|147425243|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.007|TWO_SIDED|95.0|0.15|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.97|0.15|0.007
73946395|NCT01216163|147425243|SUPERIORITY_OR_OTHER||LS mean difference|1.82|||<|0.001|TWO_SIDED|95.0|1.32|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.32|1.32|<0.001
73946396|NCT01216163|147425243|SUPERIORITY_OR_OTHER||LS mean difference|3.67|||<|0.001|TWO_SIDED|95.0|2.85|4.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.49|2.85|<0.001
73946397|NCT01216163|147425243|SUPERIORITY_OR_OTHER||LS mean difference|0.98||||0.004|TWO_SIDED|95.0|0.31|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.66|0.31|0.004
73946398|NCT01216163|147425243|SUPERIORITY_OR_OTHER||LS mean difference|2.69|||<|0.001|TWO_SIDED|95.0|1.87|3.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.51|1.87|<0.001
73946399|NCT01216163|147425243|SUPERIORITY_OR_OTHER||LS mean difference|6.8|||<|0.001|TWO_SIDED|95.0|4.96|8.64||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||8.64|4.96|<0.001
73946400|NCT01216163|147425243|SUPERIORITY_OR_OTHER||LS mean difference|2.09||||0.007|TWO_SIDED|95.0|0.59|3.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.59|0.59|0.007
74031910|NCT04657016|147617022|SUPERIORITY||Mean Difference (Net)|-11.5|STANDARD_ERROR_OF_MEAN|1.97|<|0.001|TWO_SIDED|95.0|-15.3|-7.53|||Mixed Models Analysis|||||-7.53|-15.30|<0.001
73958236|NCT05046132|147452012|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.3|-0.3||||||2 hr Post dose||-0.3|-6.3|
73958237|NCT05046132|147452012|OTHER||LS Mean|-1.2|||||TWO_SIDED|90.0|-4.1|1.7||||||2.5 hr Post dose||1.7|-4.1|
73958238|NCT05046132|147452012|OTHER||LS Mean|-1.3|||||TWO_SIDED|90.0|-4.2|1.7||||||3 hr Post dose||1.7|-4.2|
73958239|NCT05046132|147452012|OTHER||LS Mean|-0.6|||||TWO_SIDED|90.0|-3.6|2.5||||||4 hr Post dose||2.5|-3.6|
73958240|NCT05046132|147452012|OTHER||LS Mean|-1.0|||||TWO_SIDED|95.0|-4.1|2.1||||||5 hr Post dose||2.1|-4.1|
73958241|NCT05046132|147452012|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-2.7|3.5||||||6 hr Post dose||3.5|-2.7|
73958242|NCT05046132|147452012|OTHER||LS Mean|-2.5|||||TWO_SIDED|90.0|-5.5|0.5||||||7 hr Post dose||0.5|-5.5|
73958243|NCT05046132|147452012|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.2|0.8||||||8 hr Post dose||0.8|-5.2|
73958244|NCT05046132|147452012|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-4.3|2.6||||||9 hr Post dose||2.6|-4.3|
73958245|NCT05046132|147452012|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.6|3.2||||||10 hr Post dose||3.2|-3.6|
73958246|NCT05046132|147452012|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.5|1.0||||||12 hr Post dose||1.0|-5.5|
73946401|NCT01216163|147425243|SUPERIORITY_OR_OTHER||LS mean difference|4.71|||<|0.001|TWO_SIDED|95.0|2.87|6.54||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||6.54|2.87|<0.001
73976266|NCT05251363|147497801|SUPERIORITY||||||<|0.0001|||||||Exact binomial test|||Ho: SADE-free rate ≤ 87.5% Ha: SADE-free rate \> 87.5% Used an exact binomial test comparing the observed proportion (overall SADE-free rate through 3 months) to the performance goal of 87.5%. The lower, two-sided 95% confidence bound for the overall SADE-free rate must be greater than 87.5% to reject the null hypothesis (Ho), which would demonstrate evidence that the SADE-free rate is significantly higher than 87.5%.||||<0.0001
73946402|NCT01216163|147425244|SUPERIORITY_OR_OTHER||LS mean difference|3.81|||<|0.001|TWO_SIDED|95.0|3.05|4.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.57|3.05|<0.001
73946403|NCT01216163|147425244|SUPERIORITY_OR_OTHER||LS mean difference|0.76||||0.016|TWO_SIDED|95.0|0.14|1.38||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.38|0.14|0.016
73946404|NCT01216163|147425244|SUPERIORITY_OR_OTHER||LS mean difference|3.04|||<|0.001|TWO_SIDED|95.0|2.29|3.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.80|2.29|<0.001
73946405|NCT01216163|147425244|SUPERIORITY_OR_OTHER||LS mean difference|5.9|||<|0.001|TWO_SIDED|95.0|4.66|7.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.15|4.66|<0.001
73946406|NCT01216163|147425244|SUPERIORITY_OR_OTHER||LS mean difference|1.35||||0.01|TWO_SIDED|95.0|0.33|2.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.37|0.33|0.010
73946407|NCT01216163|147425244|SUPERIORITY_OR_OTHER||LS mean difference|4.56|||<|0.001|TWO_SIDED|95.0|3.31|5.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.80|3.31|<0.001
73946408|NCT01216163|147425244|SUPERIORITY_OR_OTHER||LS mean difference|10.88|||<|0.001|TWO_SIDED|95.0|8.05|13.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||13.70|8.05|<0.001
73946409|NCT01216163|147425244|SUPERIORITY_OR_OTHER||LS mean difference|2.87||||0.015|TWO_SIDED|95.0|0.57|5.18||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.18|0.57|0.015
73946410|NCT01216163|147425244|SUPERIORITY_OR_OTHER||LS mean difference|8.0|||<|0.001|TWO_SIDED|95.0|5.18|10.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||10.83|5.18|<0.001
73946411|NCT01216163|147425245|SUPERIORITY_OR_OTHER||LS mean difference|6.19|||<|0.001|TWO_SIDED|95.0|4.96|7.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.43|4.96|<0.001
73946412|NCT01216163|147425245|SUPERIORITY_OR_OTHER||LS mean difference|1.33||||0.01|TWO_SIDED|95.0|0.32|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.33|0.32|0.010
73946413|NCT01216163|147425245|SUPERIORITY_OR_OTHER||LS mean difference|4.87|||<|0.001|TWO_SIDED|95.0|3.63|6.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||6.10|3.63|<0.001
73946414|NCT01216163|147425245|SUPERIORITY_OR_OTHER||LS mean difference|9.58|||<|0.001|TWO_SIDED|95.0|7.54|11.61||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||11.61|7.54|<0.001
73946415|NCT01216163|147425245|SUPERIORITY_OR_OTHER||LS mean difference|2.33||||0.006|TWO_SIDED|95.0|0.67|4.0||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.00|0.67|0.006
73946416|NCT01216163|147425245|SUPERIORITY_OR_OTHER||LS mean difference|7.24|||<|0.001|TWO_SIDED|95.0|5.21|9.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||9.28|5.21|<0.001
73946417|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|21.42|||<|0.001|TWO_SIDED|95.0|12.99|29.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||29.84|12.99|<0.001
73946418|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|1.58||||0.799|TWO_SIDED|95.0|-10.54|13.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.70|-10.54|0.799
73946419|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|20.09||||0.001|TWO_SIDED|95.0|11.45|28.72||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||28.72|11.45|0.001
73946420|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|53.22|||<|0.001|TWO_SIDED|95.0|42.92|63.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.53|42.92|<0.001
73946421|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|-2.98||||0.695|TWO_SIDED|95.0|-17.67|11.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.70|-17.67|0.695
74031911|NCT04657016|147617023|SUPERIORITY||Mean Difference (Net)|-27.8|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-32.1|-23.2|||Mixed Models Analysis|||||-23.2|-32.1|<0.001
74031912|NCT04657016|147617024|SUPERIORITY||Mean Difference (Net)|-28.0|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-32.3|-23.4|||Mixed Models Analysis|||||-23.4|-32.3|<0.001
74031913|NCT04657016|147617025|SUPERIORITY||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-28.4|-13.6|||Mixed Models Analysis|||||-13.6|-28.4|<0.001
74031914|NCT04657016|147617026|SUPERIORITY||Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.5|-8.8|||Mixed Models Analysis|||||-8.8|-13.5|<0.001
74031915|NCT04657016|147617027|SUPERIORITY||Mean Difference (Net)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.53|-0.42|||Mixed Models Analysis|||||-0.42|-0.53|<0.001
73958247|NCT05046132|147452012|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-5.4|1.7||||||16 hr Post dose||1.7|-5.4|
73958248|NCT05046132|147452012|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-1.2|6.3||||||24 hr Post dose||6.3|-1.2|
73958249|NCT05046132|147452012|OTHER||LS Mean|-2.1|||||TWO_SIDED|90.0|-5.1|0.8||||||Pre-dose||0.8|-5.1|
73958250|NCT05046132|147452012|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.1|3.0||||||0.5 hr Post dose||3.0|-3.1|
73958251|NCT05046132|147452012|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.0|2.9||||||1 hr Post dose||2.9|-3.0|
73958252|NCT05046132|147452012|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.1|3.0||||||1.5 hr Post dose||3.0|-3.1|
73958253|NCT05046132|147452012|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.8|2.0||||||2 hr Post dose||2.0|-3.8|
73958254|NCT05046132|147452012|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.5|3.0||||||2.5 hr Post dose||3.0|-2.5|
73958255|NCT05046132|147452012|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-1.9|3.7||||||3 hr Post dose||3.7|-1.9|
73958256|NCT05046132|147452012|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.2|3.7||||||4 hr Post dose||3.7|-2.2|
73958257|NCT05046132|147452012|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.8|3.1||||||5 hr Post dose||3.1|-2.8|
73958258|NCT05046132|147452012|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.9|2.0||||||6 hr Post dose||2.0|-3.9|
73958259|NCT05046132|147452012|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.1|2.7||||||7 hr Post dose||2.7|-3.1|
73958260|NCT05046132|147452012|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.7|3.1||||||8 hr Post dose||3.1|-2.7|
73958261|NCT05046132|147452012|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.7|4.0||||||9 hr Post dose||4.0|-2.7|
73958262|NCT05046132|147452012|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-2.3|4.1||||||10 hr Post dose||4.1|-2.3|
73958263|NCT05046132|147452012|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-3.5|2.8||||||12 hr Post dose||2.8|-3.5|
73958264|NCT05046132|147452012|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-3.8|3.0||||||16 hr Post dose||3.0|-3.8|
73958265|NCT05046132|147452012|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-5.1|2.0||||||24 hr Post dose||2.0|-5.1|
73958266|NCT05046132|147452013|OTHER||LS Mean|3.5|||||TWO_SIDED|90.0|0.1|6.8||||||Pre dose||6.8|0.1|
73958267|NCT05046132|147452013|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-3.0|4.6||||||0.5 hr Post dose||4.6|-3.0|
73958268|NCT05046132|147452013|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-4.1|3.9||||||1 hr Post dose||3.9|-4.1|
73958269|NCT05046132|147452013|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-2.7|4.4||||||1.5 hr Post dose||4.4|-2.7|
73958270|NCT05046132|147452013|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|-0.6|6.6||||||2 hr Post dose||6.6|-0.6|
73958271|NCT05046132|147452013|OTHER||LS Mean|3.5|||||TWO_SIDED|90.0|-0.3|7.4||||||2.5 hr Post dose||7.4|-0.3|
73958272|NCT05046132|147452013|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|1.2|8.1||||||3 hr Post dose||8.1|1.2|
73958273|NCT05046132|147452013|OTHER||LS Mean|5.2|||||TWO_SIDED|90.0|1.5|8.9||||||4 hr Post dose||8.9|1.5|
73958274|NCT05046132|147452013|OTHER||LS Mean|2.0|||||TWO_SIDED|90.0|-1.7|5.8||||||5 hr Post dose||5.8|-1.7|
73958275|NCT05046132|147452013|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.6|5.1||||||6 hr Post dose||5.1|-1.6|
73958276|NCT05046132|147452013|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-1.1|5.7||||||7 hr Post dose||5.7|-1.1|
73946422|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|57.06|||<|0.001|TWO_SIDED|95.0|46.53|67.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||67.60|46.53|<0.001
73946423|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|70.58|||<|0.001|TWO_SIDED|95.0|60.28|80.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||80.88|60.28|<0.001
73946424|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|7.99||||0.261|TWO_SIDED|95.0|-5.85|21.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.84|-5.85|0.261
73946425|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|62.88|||<|0.001|TWO_SIDED|95.0|51.78|73.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.99|51.78|<0.001
73946426|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|66.24|||<|0.001|TWO_SIDED|95.0|53.77|78.71||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.71|53.77|<0.001
73946427|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|4.38||||0.522|TWO_SIDED|95.0|-8.89|17.64||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.64|-8.89|0.522
73946428|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|61.93|||<|0.001|TWO_SIDED|95.0|49.06|74.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.80|49.06|<0.001
73946429|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|66.35|||<|0.001|TWO_SIDED|95.0|53.61|79.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.09|53.61|<0.001
73946430|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|5.46||||0.415|TWO_SIDED|95.0|-7.53|18.44||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.44|-7.53|0.415
73946431|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|60.92|||<|0.001|TWO_SIDED|95.0|47.65|74.19||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.19|47.65|<0.001
73946432|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|65.32|||<|0.001|TWO_SIDED|95.0|52.18|78.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.46|52.18|<0.001
73946433|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|4.21||||0.519|TWO_SIDED|95.0|-8.39|16.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.81|-8.39|0.519
73946434|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
73958277|NCT05046132|147452013|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-1.4|6.2||||||8 hr Post dose||6.2|-1.4|
73958278|NCT05046132|147452013|OTHER||LS Mean|4.4|||||TWO_SIDED|90.0|0.9|7.8||||||9 hr Post dose||7.8|0.9|
73958279|NCT05046132|147452013|OTHER||LS Mean|3.8|||||TWO_SIDED|90.0|0.3|7.4||||||10 hr Post dose||7.4|0.3|
73958280|NCT05046132|147452013|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-4.2|2.7||||||12 hr Post dose||2.7|-4.2|
73958281|NCT05046132|147452013|OTHER||LS Mean|3.6|||||TWO_SIDED|90.0|0.1|7.0||||||16 hr Post dose||7.0|0.1|
73958282|NCT05046132|147452013|OTHER||LS Mean|-1.5|||||TWO_SIDED|90.0|-5.7|2.8||||||24 hr Post dose||2.8|-5.7|
73958283|NCT05046132|147452013|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-1.0|5.6||||||Pre dose||5.6|-1.0|
73958284|NCT05046132|147452013|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-5.4|2.2||||||0.5 hr Post dose||2.2|-5.4|
73958285|NCT05046132|147452013|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.8|4.3||||||1 hr Post dose||4.3|-3.8|
73958286|NCT05046132|147452013|OTHER||LS Mean|4.0|||||TWO_SIDED|90.0|0.4|7.6||||||1.5 hr Post dose||7.6|0.4|
73946435|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
73946436|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
73946437|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
73946438|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
73946439|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
73946440|NCT01216163|147425246|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
73946441|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|26.4|||<|0.001|TWO_SIDED|95.0|15.87|36.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.93|15.87|<0.001
73946442|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|3.53||||0.602|TWO_SIDED|95.0|-9.85|16.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.91|-9.85|0.602
73946443|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|22.72||||0.001|TWO_SIDED|95.0|12.39|33.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||33.05|12.39|0.001
73946444|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|60.37|||<|0.001|TWO_SIDED|95.0|48.61|72.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||72.12|48.61|<0.001
73946445|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|2.25||||0.761|TWO_SIDED|95.0|-12.1|16.59||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.59|-12.10|0.761
73946446|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|58.32|||<|0.001|TWO_SIDED|95.0|46.59|70.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||70.05|46.59|<0.001
73946447|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|67.52|||<|0.001|TWO_SIDED|95.0|54.91|80.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||80.12|54.91|<0.001
73946448|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|5.42||||0.41|TWO_SIDED|95.0|-7.34|18.18||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.18|-7.34|0.410
73946449|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|62.13|||<|0.001|TWO_SIDED|95.0|48.96|75.29||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.29|48.96|<0.001
73958287|NCT05046132|147452013|OTHER||LS Mean|6.3|||||TWO_SIDED|90.0|2.7|10.0||||||2 hr Post dose||10.0|2.7|
73870026|NCT00475904|147283985|NON_INFERIORITY_OR_EQUIVALENCE|To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.2311||0.8409|TWO_SIDED|90.0|-0.33|0.43||To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|ANCOVA|||the primary hypothesis of this study was that NP-1 topical cream (amitriptyline 4%/ketamine 2%) administered twice daily in doses of 4 gm for 4 weeks is not inferior to the standard treatment (oral gabapentin 600 mg 3 times daily) for relieving the pain of adult patients with PHN.||0.43|-0.33|0.8409
73870027|NCT00939562|147283988|SUPERIORITY_OR_OTHER||Ratio|102.95||||||90.0|94.74|111.86|||||The adjusted mean differences and 90% confidence intervals (CIs) were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed Cmax was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).||111.86|94.74|
73946450|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|68.64|||<|0.001|TWO_SIDED|95.0|56.11|81.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.16|56.11|<0.001
73946451|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
73946452|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|63.34|||<|0.001|TWO_SIDED|95.0|50.32|76.35||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||76.35|50.32|<0.001
73946453|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
73946454|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
73946455|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
73976267|NCT05251363|147497802|SUPERIORITY||||||<|0.0001|||||||Exact binomial test|||H0: Implant Success Rate ≤ 80% Ha: Implant Success Rate \> 80% Used an exact binomial test comparing the observed proportion (implant success rate) to the performance goal of 80%. The lower, two-sided 95% confidence bound for the overall implant success rate must be greater than 80% to reject the null hypothesis (Ho), which would demonstrate evidence that the rate of successful Solia S LBBA implants is significantly higher than 80.0%.||||< 0.0001
73976268|NCT05251363|147497803|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||H0: Improvement in QOL Physical Function Scale ≤ 2.8 Ha: Improvement in QOL Physical Function Scale \> 2.8 Exact one-sample t-test comparing mean improvement in QOL from baseline to 12-mo post-implant to a goal of +2.8. The lower, two-sided 95% confidence bound for the improvement in QOL must be \> +2.8 to reject H0.||||<0.001
73946456|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
73946457|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
73946458|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
74031916|NCT04657016|147617028|SUPERIORITY||Mean Difference (Net)|-48.1|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-53.7|-41.7|||Mixed Models Analysis|||||-41.7|-53.7|<0.001
73870028|NCT00939562|147283989|SUPERIORITY_OR_OTHER||Ratio|104.67||||||90.0|98.95|110.73|||||The adjusted mean differences and 90% CIs were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed AUCinf was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).||110.73|98.95|
74031917|NCT04657016|147617029|SUPERIORITY||Mean Difference (Net)|3.8|||<|0.001|TWO_SIDED|95.0|2.8|4.9|||ANCOVA|||||4.9|2.8|<0.001
73870029|NCT03422536|147283990|EQUIVALENCE|The pre-specified significance criteria were met by exclusion of the historical control PFS of 2.0 months. As confirmation, the one-sample log rank test was computed with expected survival estimated using an exponential distribution of 2.0 months.||||||0.04||||||The a priori threshold for statistical significance is \<.05|Log Rank|||||||.04
73870030|NCT03422536|147283995|SUPERIORITY|||||||0.005|||||||Regression, Cox|||c-Met positivity was compared across groups: HPV+ vs HPV-||||.005
73870031|NCT03422536|147283995|SUPERIORITY||Cox Proportional Hazard|0.3||||0.02|TWO_SIDED|95.0|0.1|0.8|||Log Rank|||Post-hoc comparison of progression free survival (PFS) in cMet positive vs. c-Met negative patients.||0.8|0.1|.02
73870032|NCT03422536|147283995|SUPERIORITY||Cox Proportional Hazard|0.1||||0.03|TWO_SIDED|95.0|0.03|0.8|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at cMet positivity in HPV- patients in the combination arm.||0.8|0.03|0.03
73870033|NCT03422536|147283995|SUPERIORITY||Cox Proportional Hazard|3.2||||0.2|TWO_SIDED|95.0|0.6|17.5|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at cMet positivity in HPV+ patients in the combination arm.||17.5|0.6|.20
73946459|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
73946460|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
73870034|NCT03422536|147283995|SUPERIORITY||Cox Proportional Hazard|1.4||||0.1|TWO_SIDED|95.0|0.9|2.0|||Log Rank|||Post-hoc comparison of progression free survival (PFS) in HGF positive vs. HGF negative patients.||2.0|0.9|.10
73870035|NCT03422536|147283995|SUPERIORITY||Cox Proportional Hazard|1.4||||0.6|TWO_SIDED|95.0|0.4|4.7|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at HGF expression in HPV- patients in the combination arm.||4.7|0.4|.60
73870036|NCT03422536|147283995|SUPERIORITY||Cox Proportional Hazard|3.4||||0.07|TWO_SIDED|95.0|0.9|13.1|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P \< .10), was assessed using Cox proportional hazards models. Here we are looking at HGF expression in HPV+ patients in the combination arm.||13.1|0.9|.07
73870037|NCT04531241|147283999|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort and vision at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of -5 points was used.|Least-Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-6.8|1.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||1.1|-6.8|
73870038|NCT04531241|147284000|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 0.05 logMAR unit difference in logMAR visual acuity at LLHC and HLLC lighting conditions at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 0.05 logMAR units was used.|Least-Square Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|95.0|-0.0199|0.0|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Low Luminance High Contrast||0.0|-0.0199|
73870039|NCT04531241|147284000|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 0.05 logMAR unit difference in logMAR visual acuity at LLHC and HLLC lighting conditions at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 0.05 logMAR units was used.|Least-Square Mean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.0066|||TWO_SIDED|95.0|-0.0173|0.0087|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|High Luminance Low Contrast||0.0087|-0.0173|
73946461|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
73946462|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
73946463|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
73946464|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
73946465|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
73946466|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
73946467|NCT01216163|147425247|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
73946468|NCT01216163|147425248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.22|0.08|<0.001
73946469|NCT01216163|147425248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.303|TWO_SIDED|95.0|0.45|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.28|0.45|0.303
73946470|NCT01216163|147425248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.1|0.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.28|0.10|<0.001
73946471|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-40.1|||<|0.001|TWO_SIDED|95.0|-55.39|-24.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-24.80|-55.39|<0.001
73946472|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-0.12||||0.958|TWO_SIDED|95.0|-4.52|4.28||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.28|-4.52|0.958
73946473|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-40.19|||<|0.001|TWO_SIDED|95.0|-55.51|-24.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-24.87|-55.51|<0.001
73946474|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-63.4|||<|0.001|TWO_SIDED|95.0|-77.81|-48.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-48.99|-77.81|<0.001
73946475|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-7.17||||0.108|TWO_SIDED|95.0|-15.91|1.57||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.57|-15.91|0.108
73946476|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-56.39|||<|0.001|TWO_SIDED|95.0|-71.68|-41.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-41.09|-71.68|<0.001
74031918|NCT04657016|147617030|SUPERIORITY||Mean Difference (Net)|12.8|||<|0.001|TWO_SIDED|95.0|9.7|16.0|||ANCOVA|||||16.0|9.7|<0.001
73958288|NCT05046132|147452013|OTHER||LS Mean|6.4|||||TWO_SIDED|90.0|2.6|10.2||||||2.5 hr Post dose||10.2|2.6|
73958289|NCT05046132|147452013|OTHER||LS Mean|8.5|||||TWO_SIDED|90.0|5.0|12.0||||||3 hr Post dose||12.0|5.0|
73870040|NCT04531241|147284001|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 1 hour difference in average daily wear time at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 1 hour was used.|Least-Square Mean Difference|-0.052|STANDARD_ERROR_OF_MEAN|0.0731|||TWO_SIDED|95.0|-0.1968|0.0933|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||0.0933|-0.1968|
73946477|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-71.01|||<|0.001|TWO_SIDED|95.0|-84.09|-57.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-57.93|-84.09|<0.001
74031919|NCT02361762|147617084|OTHER|||||||0.36|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.36
73946478|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-9.82||||0.083|TWO_SIDED|95.0|-20.18|1.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.16|-20.18|0.083
73946479|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-61.14|||<|0.001|TWO_SIDED|95.0|-75.4|-46.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.87|-75.40|<0.001
73946480|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-66.37|||<|0.001|TWO_SIDED|95.0|-80.08|-52.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-52.66|-80.08|<0.001
73946481|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-11.03||||0.079|TWO_SIDED|95.0|-23.37|1.21||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.21|-23.37|0.079
73946482|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-55.53|||<|0.001|TWO_SIDED|95.0|-70.12|-40.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-40.85|-70.12|<0.001
73946483|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-57.33|||<|0.001|TWO_SIDED|95.0|-71.9|-42.77||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-42.77|-71.90|<0.001
73946484|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-7.73||||0.263|TWO_SIDED|95.0|-21.08|5.63||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.63|-21.08|0.263
73946485|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-49.93|||<|0.001|TWO_SIDED|95.0|-64.74|-35.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-35.12|-64.74|<0.001
73946486|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-52.75|||<|0.001|TWO_SIDED|95.0|-67.62|-37.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-37.88|-67.62|<0.001
73946487|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-5.51||||0.439|TWO_SIDED|95.0|-19.27|8.25||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.25|-19.27|0.439
74031920|NCT02361762|147617085|OTHER|||||||0.79|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.79
74031921|NCT02361762|147617086|OTHER|||||||0.009|||||||ANOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Congruent/Incongruent)||||||0.009
73870041|NCT04531241|147284002|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort and vision at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of -5 points was used.|Least-Square Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|95.0|-5.5|0.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||0.3|-5.5|
73958290|NCT05046132|147452013|OTHER||LS Mean|10.1|||||TWO_SIDED|90.0|6.4|13.8||||||4 hr Post dose||13.8|6.4|
73870042|NCT00395850|147284008|SUPERIORITY_OR_OTHER||Slope|-1.02|||<|0.05|||||||Repeated Measures Logistic Regression|Repeated Measures Generalized Linear Models on a Binomial distribution, thus a Repeated Measures Logistic Regression||Used placebo group as contrast to determine whether slopes of disulfiram groups differed from slope of placebo group data||||<0.05
73870043|NCT00395850|147284009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
74031922|NCT02361762|147617087|OTHER|||||||0.79||||||ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|ANCOVA|Compared scores at post testing with baseline scores covaried.||||||.79
74031923|NCT02361762|147617088|OTHER|||||||0.61|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.61
74031924|NCT02361762|147617089|OTHER|||||||0.68|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)0.||||||0.68
73870044|NCT02910102|147284028|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.3565|TWO_SIDED|95.0|-6.04|2.23||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.||||2.23|-6.04|0.3565
73870045|NCT02910102|147284029|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.922|TWO_SIDED|95.0|-3.73|3.38||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.||||3.38|-3.73|0.9220
73870046|NCT00095173|147284030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.0002|TWO_SIDED|95.0|0.16|0.59|||Log Rank||Abatacept over placebo|||0.59|0.16|0.0002
73870047|NCT00095173|147284031|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73870048|NCT02578186|147284067|SUPERIORITY_OR_OTHER|||||||0.0312|||||||ANCOVA|||||||0.0312
73870049|NCT01320202|147284080|SUPERIORITY_OR_OTHER||Difference in LS Means between SFP & PBO|3.6|STANDARD_ERROR_OF_MEAN|1.4||0.011|TWO_SIDED|||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA|||||||0.011
73958291|NCT05046132|147452013|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|4.1|11.6||||||5 hr Post dose||11.6|4.1|
73958292|NCT05046132|147452013|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|4.4|11.2||||||6 hr Post dose||11.2|4.4|
73958293|NCT05046132|147452013|OTHER||LS Mean|6.8|||||TWO_SIDED|90.0|3.4|10.2||||||7 hr Post dose||10.2|3.4|
73958294|NCT05046132|147452013|OTHER||LS Mean|4.5|||||TWO_SIDED|90.0|0.6|8.3||||||8 hr Post dose||8.3|0.6|
73958295|NCT05046132|147452013|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|3.1|10.0||||||9 hr Post dose||10.0|3.1|
73958296|NCT05046132|147452013|OTHER||LS Mean|6.6|||||TWO_SIDED|90.0|3.0|10.1||||||10 hr Post dose||10.1|3.0|
73958297|NCT05046132|147452013|OTHER||LS Mean|5.3|||||TWO_SIDED|90.0|1.8|8.8||||||12 hr Post dose||8.8|1.8|
73958298|NCT05046132|147452013|OTHER||LS Mean|7.2|||||TWO_SIDED|90.0|3.7|10.6||||||16 hr Post dose||10.6|3.7|
73958299|NCT05046132|147452013|OTHER||LS Mean|3.3|||||TWO_SIDED|90.0|-1.0|7.5||||||24 hr Post dose||7.5|-1.0|
73958300|NCT05046132|147452014|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|3.7|11.8||||||Pre dose||11.8|3.7|
73958301|NCT05046132|147452014|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|3.3|9.8||||||0.5 hr Post dose||9.8|3.3|
73958302|NCT05046132|147452014|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|0.6|8.6||||||1 hr Post dose||8.6|0.6|
73958303|NCT05046132|147452014|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|0.6|8.6||||||1.5 hr Post dose||8.6|0.6|
73958304|NCT05046132|147452014|OTHER||LS Mean|3.8|||||TWO_SIDED|90.0|-0.4|8.0||||||2 hr Post dose||8.0|-0.4|
73958305|NCT05046132|147452014|OTHER||LS Mean|6.1|||||TWO_SIDED|90.0|1.8|10.4||||||2.5 hr Post dose||10.4|1.8|
73958306|NCT05046132|147452014|OTHER||LS Mean|5.7|||||TWO_SIDED|90.0|1.7|9.8||||||3 hr Post dose||9.8|1.7|
73958307|NCT05046132|147452014|OTHER||LS Mean|6.2|||||TWO_SIDED|90.0|2.5|9.8||||||4 hr Post dose||9.8|2.5|
73958308|NCT05046132|147452014|OTHER||LS Mean|5.7|||||TWO_SIDED|90.0|1.6|9.8||||||5 hr Post dose||9.8|1.6|
73958309|NCT05046132|147452014|OTHER||LS Mean|4.8|||||TWO_SIDED|90.0|1.1|8.4||||||6 hr Post dose||8.4|1.1|
73958310|NCT05046132|147452014|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|-0.9|7.0||||||7 hr Post dose||7.0|-0.9|
73958311|NCT05046132|147452014|OTHER||LS Mean|5.0|||||TWO_SIDED|90.0|1.3|8.8||||||8 hr Post dose||8.8|1.3|
73958312|NCT05046132|147452014|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|2.5|10.6||||||9 hr Post dose||10.6|2.5|
73958313|NCT05046132|147452014|OTHER||LS Mean|8.6|||||TWO_SIDED|90.0|4.8|12.3||||||10 hr Post dose||12.3|4.8|
73958314|NCT05046132|147452014|OTHER||LS Mean|7.9|||||TWO_SIDED|90.0|4.4|11.4||||||12 hr Post dose||11.4|4.4|
73958315|NCT05046132|147452014|OTHER||LS Mean|4.9|||||TWO_SIDED|90.0|0.9|8.9||||||16 hr Post dose||8.9|0.9|
73958316|NCT05046132|147452014|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|3.6|12.0||||||24 hr Post dose||12.0|3.6|
73958317|NCT05046132|147452014|OTHER||LS Mean|2.1|||||TWO_SIDED|90.0|-1.8|6.0||||||Pre dose||6.0|-1.8|
73958318|NCT05046132|147452014|OTHER||LS Mean|3.1|||||TWO_SIDED|90.0|0.0|6.2||||||0.5 hr Post dose||6.2|-0.0|
73958319|NCT05046132|147452014|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.9|5.7||||||1 hr Post dose||5.7|-1.9|
73958320|NCT05046132|147452014|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|2.6|10.4||||||1.5 hr Post dose||10.4|2.6|
73958321|NCT05046132|147452014|OTHER||LS Mean|5.3|||||TWO_SIDED|90.0|1.3|9.3||||||2 hr Post dose||9.3|1.3|
73958322|NCT05046132|147452014|OTHER||LS Mean|11.1|||||TWO_SIDED|90.0|7.0|15.1||||||2.5 hr Post dose||15.1|7.0|
73958323|NCT05046132|147452014|OTHER||LS Mean|9.8|||||TWO_SIDED|90.0|5.9|13.6||||||3 hr Post dose||13.6|5.9|
73958324|NCT05046132|147452014|OTHER||LS Mean|10.7|||||TWO_SIDED|90.0|7.2|14.2||||||4 hr Post dose||14.2|7.2|
73958325|NCT05046132|147452014|OTHER||LS Mean|8.8|||||TWO_SIDED|90.0|4.9|12.7||||||5 hr Post dose||12.7|4.9|
73958326|NCT05046132|147452014|OTHER||LS Mean|11.0|||||TWO_SIDED|90.0|7.5|14.5||||||6 hr Post dose||14.5|7.5|
73958327|NCT05046132|147452014|OTHER||LS Mean|10.8|||||TWO_SIDED|90.0|7.1|14.6||||||7 hr Post dose||14.6|7.1|
73958328|NCT05046132|147452014|OTHER||LS Mean|11.3|||||TWO_SIDED|90.0|7.6|14.9||||||8 hr Post dose||14.9|7.6|
73958329|NCT05046132|147452014|OTHER||LS Mean|9.8|||||TWO_SIDED|90.0|5.9|13.7||||||9 hr Post dose||13.7|5.9|
73946488|NCT01216163|147425249|SUPERIORITY_OR_OTHER||Difference in proportion|-47.72|||<|0.001|TWO_SIDED|95.0|-62.62|-32.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-32.83|-62.62|<0.001
74031925|NCT02361762|147617090|OTHER|||||||0.54|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.54
73946489|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.294|TWO_SIDED|95.0|-3.59|1.17||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.17|-3.59|0.294
73946490|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|1.21||||0.458|TWO_SIDED|95.0|-1.16|3.58||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.58|-1.16|0.458
73946491|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|6.81||||0.073|TWO_SIDED|95.0|1.57|12.06||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.06|1.57|0.073
73946492|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|1.96||||0.583|TWO_SIDED|95.0|-4.94|8.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.85|-4.94|0.583
73946493|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|4.81||||0.137|TWO_SIDED|95.0|0.14|9.49||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.49|0.14|0.137
73946494|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|23.86|||<|0.001|TWO_SIDED|95.0|14.81|32.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||32.91|14.81|<0.001
73946495|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|8.45||||0.165|TWO_SIDED|95.0|-3.43|20.33||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.33|-3.43|0.165
73946496|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|15.46||||0.006|TWO_SIDED|95.0|7.66|23.26||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.26|7.66|0.006
73946497|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|29.41|||<|0.001|TWO_SIDED|95.0|19.78|39.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.05|19.78|<0.001
73946498|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|4.61||||0.497|TWO_SIDED|95.0|-8.78|17.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.99|-8.78|0.497
73946499|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|25.13|||<|0.001|TWO_SIDED|95.0|15.81|34.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||34.46|15.81|<0.001
74031926|NCT02361762|147617091|OTHER|||||||0.08|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.08
74031927|NCT02361762|147617092|OTHER|||||||0.37|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.37
74031928|NCT02361762|147617094|OTHER|||||||0.62|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.62
74031929|NCT02361762|147617095|OTHER|||||||0.1|||||||ANCOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Go/Nogo)||||||0.10
73958330|NCT05046132|147452014|OTHER||LS Mean|10.5|||||TWO_SIDED|90.0|6.9|14.1||||||10 hr Post dose||14.1|6.9|
73958331|NCT05046132|147452014|OTHER||LS Mean|11.8|||||TWO_SIDED|90.0|8.4|15.2||||||12 hr Post dose||15.2|8.4|
74031930|NCT02361762|147617096|OTHER|||||||0.02|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.02
73946500|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|31.78|||<|0.001|TWO_SIDED|95.0|20.03|43.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||43.53|20.03|<0.001
73946501|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|6.7||||0.349|TWO_SIDED|95.0|-7.38|20.79||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.79|-7.38|0.349
73946502|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|25.34|||<|0.001|TWO_SIDED|95.0|13.73|36.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.94|13.73|<0.001
73946503|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|37.64|||<|0.001|TWO_SIDED|95.0|25.47|49.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||49.81|25.47|<0.001
73946504|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|8.85||||0.233|TWO_SIDED|95.0|-5.72|23.42||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.42|-5.72|0.233
73946505|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|28.96|||<|0.001|TWO_SIDED|95.0|17.17|40.75||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||40.75|17.17|<0.001
73946506|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|38.73|||<|0.001|TWO_SIDED|95.0|25.87|51.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.60|25.87|<0.001
73946507|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|9.83||||0.189|TWO_SIDED|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.45|-4.80|0.189
73946508|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|29.19|||<|0.001|TWO_SIDED|95.0|16.71|41.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||41.66|16.71|<0.001
73946509|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|36.55|||<|0.001|TWO_SIDED|95.0|23.22|49.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||49.88|23.22|<0.001
73946510|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|9.83||||0.189|TWO_SIDED|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.45|-4.80|0.189
74031931|NCT04985799|147617099|NON_INFERIORITY|For the sample size, a total of 143 participants, or 72 participants per group was needed, based on a 90% effectiveness for both slings 14% non-inferiority margin, 80% power, alpha of 0.05 and a 20% dropout rate.|Risk Difference (RD)|14.8||||0.04|TWO_SIDED|95.0|1.1|28.5|||Chi-squared|||||28.5|1.1|0.04
73958332|NCT05046132|147452014|OTHER||LS Mean|9.4|||||TWO_SIDED|90.0|5.6|13.3||||||16 hr Post dose||13.3|5.6|
73958333|NCT05046132|147452014|OTHER||LS Mean|10.8|||||TWO_SIDED|90.0|6.8|14.9||||||24 hr Post dose||14.9|6.8|
73958334|NCT05046132|147452015|OTHER||LS Mean|-5.3|||||TWO_SIDED|90.0|-8.4|-2.2||||||Pre dose||-2.2|-8.4|
73958335|NCT05046132|147452015|OTHER||LS Mean|-2.7|||||TWO_SIDED|90.0|-5.9|0.5||||||0.5 hr Post dose||0.5|-5.9|
74031932|NCT04985799|147617100|NON_INFERIORITY|For the sample size, a total of 143 participants, or 72 participants per group was needed, based on a 90% effectiveness for both slings 14% non-inferiority margin, 80% power, alpha of 0.05 and a 20% dropout rate.|Risk Difference (RD)|7.4||||0.29|TWO_SIDED|95.0|-6.2|21.1|||Chi-squared|||||21.1|-6.2|0.29
74031933|NCT04985799|147617102|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
74031934|NCT04467164|147617156|SUPERIORITY|||||||0.03|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the subgenual anterior cingulate cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.03
74031935|NCT04467164|147617156|SUPERIORITY|||||||0.022|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the orbitofrontal cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.022
73976269|NCT03835754|147497815|OTHER|Confidence internal is 88.8%, upper bound limit 99.2%|Clopper Pearson exact confidence interva|96.0|||||TWO_SIDED|95.0|88.8|99.2||||||||99.2|88.8|
73976270|NCT03044158|147497873|SUPERIORITY||Rate Ratio (adjusted)|1.56|||||TWO_SIDED|95.0|1.21|2.01||||||||2.01|1.21|
73976271|NCT03044158|147497874|SUPERIORITY||Rate Ratio (adjusted)|1.28|||||TWO_SIDED|95.0|0.99|1.66||||||||1.66|0.99|
73976272|NCT03044158|147497875|SUPERIORITY||Geometric Mean Ratio (adjusted)|0.49|||||TWO_SIDED|95.0|0.39|0.62||||||||0.62|0.39|
73976273|NCT03044158|147497876|SUPERIORITY||Rate Ratio (adjusted)|1.48|||||TWO_SIDED|95.0|1.04|2.12||||||||2.12|1.04|
74031936|NCT04467164|147617156|SUPERIORITY|||||||0.027|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the ventromedial prefrontal cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.027
74031937|NCT04467164|147617157|SUPERIORITY|||||||0.03|||||||ANOVA|||Null hypothesis is that there was no difference in the change in BDI scale score between exhalatory-gated tVNS and inhalatory-gated tVNS. A repeated measures ANOVA controlled by baseline values was used to test this difference. A p\<0.05 was designated for statistical significance. A positive difference indicates an increase in depressive symptomatology, whereas a negative difference indicates a reduction in depressive symptoms.||||0.03
74031938|NCT04467164|147617158|SUPERIORITY|||||||0.01|||||||Regression, Linear|||The null hypothesis is that there were no differences in percent HFn changes post-pre stimulation between exhalatory-gated and inhalatory-gated tVNS. A General Linear Model (GLM) analysis adjusted by baseline values was used for evaluating differences in this measure between treatment groups. A p\<0.05 was designated for statistical significance. A positive percent change value indicates an increase in cardiovagal activity, whereas a negative change indicates a reduction in cardiovagal activity.||||0.01
74031939|NCT02369835|147617159|OTHER|||||||0.8872|||||||Chi-squared|||||||.8872
74031940|NCT03650452|147617185|SUPERIORITY||Hodges-Lehmann Estimation|-30.48||||0.0007|TWO_SIDED|95.0|-46.99|-13.19||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed Analysis of Covariance (ANCOVA) adjusting for baseline seizure frequency and indication.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-13.19|-46.99|0.0007
74031941|NCT03650452|147617186|SUPERIORITY||Hodges-Lehmann Estimate|-25.93||||0.0024|TWO_SIDED|95.0|-43.96|-10.69||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency and indication.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-10.69|-43.96|0.0024
74031942|NCT03650452|147617187|SUPERIORITY||Hodges-Lehmann Estimate|-50.0||||0.0001|TWO_SIDED|95.0|-75.03|-25.09||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-25.09|-75.03|0.0001
74031943|NCT03650452|147617188|SUPERIORITY||Hodges-Lehmann Estimate|-16.22||||0.147|TWO_SIDED|95.0|-39.5|4.49||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||4.49|-39.50|0.1470
73976274|NCT03044158|147497877|SUPERIORITY||Geometric Mean Ratio (adjusted)|0.35|||||TWO_SIDED|95.0|0.21|0.56||||||||0.56|0.21|
73976275|NCT03044158|147497878|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.44|1.35||||||||1.35|0.44|
73976276|NCT00092534|147497976|SUPERIORITY_OR_OTHER_LEGACY||Percent relative risk reduction|96.6||||||95.0|88.2|99.6|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter|||99.6|88.2|
73976277|NCT01478594|147498051|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.706|TWO_SIDED|95.0|0.693|1.718|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|An interim futility analysis was to be performed when approximately 83 PFS events (50% of the total PFS events) were observed. The Lans DeMets beta spending function with an O'Brien-Fleming boundary was used to derive the futility boundary. If the hazard ratio (HR) for PFS was greater than 1.0581, enrollment was to be stopped. With this futility stopping rule, the adjusted study power was 78.6%.||1.718|0.693|0.706
74031944|NCT03650452|147617191|SUPERIORITY||Least Square (LS) Mean|0.1|STANDARD_DEVIATION|0.21||0.6829|TWO_SIDED|95.0|-0.32|0.49||The p-value is 2-sided and it is for the difference (TAK-935 - Placebo) of change from baseline between TAK-935 and Placebo was computed using MMRM.|Mixed-Model Repeated Measure (MMRM)||The MMRM model included treatment and visit as factors along with treatment\*visit interaction and baseline score as a covariate; and visit as repeated measure.|||0.49|-0.32|0.6829
74031945|NCT02273050|147617196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.885|STANDARD_ERROR_OF_MEAN|0.0994|<|0.001|TWO_SIDED|95.0|-1.08|-0.689|||ANCOVA|||||-0.689|-1.080|<0.001
74031946|NCT02273050|147617196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.213|STANDARD_ERROR_OF_MEAN|0.1005||0.034|TWO_SIDED|95.0|-0.41|-0.016|||ANCOVA|||||-0.016|-0.410|0.034
74031947|NCT02273050|147617197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.5|||<|0.001|TWO_SIDED|95.0|29.0|46.0|||Fisher Exact|||||46.0|29.0|<0.001
74031948|NCT02273050|147617197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.7||||0.011|TWO_SIDED|95.0|2.6|18.9|||Fisher Exact|||||18.9|2.6|0.011
74031949|NCT02273050|147617198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39|STANDARD_ERROR_OF_MEAN|0.158|<|0.001|TWO_SIDED|95.0|-1.7|-1.08|||ANCOVA|||||-1.08|-1.70|<0.001
74031950|NCT02273050|147617198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.159||0.046|TWO_SIDED|95.0|-0.63|0.0|||ANCOVA|||||0.00|-0.63|0.046
74031951|NCT02273050|147617199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-416.0|STANDARD_ERROR_OF_MEAN|51.54|<|0.001|TWO_SIDED|95.0|-517.3|-314.6|||ANCOVA|||||-314.6|-517.3|<0.001
74031952|NCT02273050|147617199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-169.3|STANDARD_ERROR_OF_MEAN|52.05||0.001|TWO_SIDED|95.0|-271.7|-66.9|||ANCOVA|||||-66.9|-271.7|0.001
74031953|NCT02273050|147617200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.9|||<|0.001|TWO_SIDED|95.0|26.0|43.9|||Fisher Exact|||||43.9|26.0|<0.001
74031954|NCT02273050|147617200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.6||||0.02|TWO_SIDED|95.0|2.3|20.9|||Fisher Exact|||||20.9|2.3|0.020
74031955|NCT02273050|147617201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.97|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-3.7|-2.25|||ANCOVA|||||-2.25|-3.70|<0.001
74031956|NCT02273050|147617201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.374||0.002|TWO_SIDED|95.0|-1.88|-0.41|||ANCOVA|||||-0.41|-1.88|0.002
74031957|NCT02273050|147617202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-13.3|-4.5|||Fisher Exact|||||-4.5|-13.3|<0.001
74031958|NCT02273050|147617202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||>|0.999|TWO_SIDED|95.0|-2.3|2.3|||Fisher Exact|||||2.3|-2.3|>0.999
74031959|NCT01703286|147617211|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|0.884||||0.5403|TWO_SIDED|90.0|0.633|1.235|||ANOVA|||||1.235|0.633|0.5403
74031960|NCT01703286|147617211|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|0.884||||0.5402|TWO_SIDED|90.0|0.632|1.235|||ANOVA|||||1.235|0.632|0.5402
74031961|NCT01703286|147617211|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.0||||0.9989|TWO_SIDED|90.0|0.715|1.397|||ANOVA|||||1.397|0.715|0.9989
73958336|NCT05046132|147452015|OTHER||LS Mean|-3.2|||||TWO_SIDED|90.0|-5.7|-0.7||||||1 hr Post dose||-0.7|-5.7|
73958337|NCT05046132|147452015|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.7|1.9||||||1.5 hr Post dose||1.9|-3.7|
73958338|NCT05046132|147452015|OTHER||LS Mean|-2.9|||||TWO_SIDED|90.0|-5.7|-0.2||||||2 hr Post dose||-0.2|-5.7|
73958339|NCT05046132|147452015|OTHER||LS Mean|-4.0|||||TWO_SIDED|90.0|-6.5|-1.5||||||2.5 hr Post dose||-1.5|-6.5|
73958340|NCT05046132|147452015|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.1|-1.3||||||3 hr Post dose||-1.3|-7.1|
73958341|NCT05046132|147452015|OTHER||LS Mean|-4.1|||||TWO_SIDED|90.0|-7.4|-0.8||||||4 hr Post dose||-0.8|-7.4|
73958342|NCT05046132|147452015|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-3.7|2.1||||||5 hr Post dose||2.1|-3.7|
73958343|NCT05046132|147452015|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.3|-0.4||||||6 hr Post dose||-0.4|-6.3|
73958344|NCT05046132|147452015|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.0|-0.5||||||7 hr Post dose||-0.5|-6.0|
73958345|NCT05046132|147452015|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.7|1.5||||||8 hr Post dose||1.5|-4.7|
73958346|NCT05046132|147452015|OTHER||LS Mean|-4.0|||||TWO_SIDED|90.0|-6.9|-1.2||||||9 hr Post dose||-1.2|-6.9|
73958347|NCT05046132|147452015|OTHER||LS Mean|-4.3|||||TWO_SIDED|90.0|-7.6|-1.0||||||10 hr Post dose||-1.0|-7.6|
73958348|NCT05046132|147452015|OTHER||LS Mean|-5.4|||||TWO_SIDED|90.0|-8.7|-2.1||||||12 hr Post dose||-2.1|-8.7|
74031962|NCT01703286|147617212|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.208||||0.3885|TWO_SIDED|90.0|0.84|1.738|||ANOVA|||||1.738|0.840|0.3885
74031963|NCT01703286|147617212|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.251||||0.3105|TWO_SIDED|90.0|0.868|1.801|||ANOVA|||||1.801|0.868|0.3105
74031964|NCT01703286|147617212|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.035||||0.8749|TWO_SIDED|90.0|0.721|1.485|||ANOVA|||||1.485|0.721|0.8749
74031965|NCT01703286|147617213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.048||0.2982|TWO_SIDED|90.0|-0.13|0.03|||ANOVA|||||0.030|-0.130|0.2982
74031966|NCT01703286|147617213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.048||0.6601|TWO_SIDED|90.0|-0.059|0.101|||ANOVA|||||0.101|-0.059|0.6601
74031967|NCT01703286|147617213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072|STANDARD_ERROR_OF_MEAN|0.048||0.1412|TWO_SIDED|90.0|-0.009|0.152|||ANOVA|||||0.152|-0.009|0.1412
73946511|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|26.97|||<|0.001|TWO_SIDED|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.94|14.00|<0.001
73946512|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|37.72|||<|0.001|TWO_SIDED|95.0|24.36|51.07||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.07|24.36|<0.001
73946513|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|10.97||||0.144|TWO_SIDED|95.0|-3.67|25.61||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||25.61|-3.67|0.144
73946514|NCT01216163|147425250|SUPERIORITY_OR_OTHER||Difference in proportion|26.97|||<|0.001|TWO_SIDED|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.94|14.00|<0.001
73946515|NCT01216163|147425251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.001|TWO_SIDED|95.0|0.78|0.96||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.96|0.78|<0.001
73946516|NCT01216163|147425251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.02|TWO_SIDED|95.0|0.05|0.45||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Acetaminophen) and the associated CI were calculated based on the weighted Gamma statistic.||0.45|0.05|0.020
73946517|NCT01216163|147425251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|||<|0.001|TWO_SIDED|95.0|0.63|0.91||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Acetaminophen - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.91|0.63|<0.001
73946518|NCT01859793|147425287|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Primary and secondary outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected. A priori sample size calculation demonstrated our study design has 80% power to detect a 1.5% absolute increase in FMD% with 30 subjects completing the entire study protocol at α=0.05.||||<0.05
73946519|NCT01859793|147425288|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected||||<0.05
73946520|NCT01859793|147425289|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected||||<0.05
73946521|NCT02413463|147425318|SUPERIORITY|Chi-square test||||||0.18||||||This is the calculated p-value for the success rate in the Augmented Group Vs. Faden Group|Chi-squared|||An estimation of sample size was performed considering a study power of 0.8 with an alpha error of 0.05 aiming to detect a difference of 5 Δ in the postoperative angle disparity between the 2 groups, assuming a postoperative standard deviation of 6 Δ. Based on this estimation, a total of 24 eyes were found to be adequate in each group, and considering a 25% dropout during the follow-up, recruitment of 30 study subjects in each group was targeted||||0.18
73976278|NCT01478594|147498053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.116||||0.754|TWO_SIDED|95.0|0.561|2.218|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||2.218|0.561|0.754
73946522|NCT02413463|147425319|SUPERIORITY|||||||0.22||||||This is the calculated p-value for the postoperative angle of deviation with spectacles for distance in Augmented recession vs. Faden group (First row)|t-test, 2 sided|||||||0.22
73946523|NCT02413463|147425320|SUPERIORITY|||||||0.02||||||This is the calculated p-value for the postoperative angle of deviation without spectacles for near in Augmented recession vs. Faden group (Second row)|t-test, 2 sided|||||||0.02
73946524|NCT02413463|147425321|SUPERIORITY|||||||0.03||||||This is the calculated p-value for the postoperative angle disparity in the Augmented Group Vs. Faden Group|t-test, 2 sided|||||||0.03
73946525|NCT02413463|147425322|SUPERIORITY||||||<|0.01||||||This is the calculated p-value for the intraoperative time in the Augmented Group Vs. Faden Group|t-test, 2 sided|||||||<0.01
73946526|NCT04146896|147425333|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||||||0.704
73946527|NCT04146896|147425334|SUPERIORITY|||||||0.684|||||||t-test, 2 sided|||||||.684
73946528|NCT04146896|147425335|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
73946529|NCT04146896|147425336|SUPERIORITY|||||||0.483|||||||t-test, 2 sided|||||||.483
73946530|NCT04146896|147425337|SUPERIORITY|||||||0.199|||||||t-test, 2 sided|||||||.199
73946531|NCT04146896|147425338|SUPERIORITY|||||||0.273|||||||t-test, 2 sided|||||||.273
73946532|NCT04146896|147425339|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||||||.668
73946533|NCT02277743|147425362|SUPERIORITY||difference in percentages|27.7|||<|0.0001|TWO_SIDED|95.0|20.18|35.17||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||35.17|20.18|< 0.0001
73946534|NCT02277743|147425362|SUPERIORITY||difference in percentages|27.0|||<|0.0001|TWO_SIDED|95.0|19.47|34.44||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.44|19.47|< 0.0001
73946535|NCT02277743|147425363|SUPERIORITY||difference in percentages|36.6|||<|0.0001|TWO_SIDED|95.0|28.58|44.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||44.63|28.58|< 0.0001
73946536|NCT02277743|147425363|SUPERIORITY||difference in percentages|37.7|||<|0.0001|TWO_SIDED|95.0|29.7|45.77||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||45.77|29.70|< 0.0001
73946537|NCT02277743|147425364|SUPERIORITY||difference in percentages|28.6|||<|0.0001|TWO_SIDED|95.0|20.64|36.52||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.52|20.64|< 0.0001
73946538|NCT02277743|147425364|SUPERIORITY||difference in percentages|28.0|||<|0.0001|TWO_SIDED|95.0|19.94|36.13||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.13|19.94|< 0.0001
73946539|NCT02277743|147425365|SUPERIORITY||difference in percentages|29.6|||<|0.0001|TWO_SIDED|95.0|21.36|37.88||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||37.88|21.36|< 0.0001
73946540|NCT02277743|147425365|SUPERIORITY||difference in percentages|34.5|||<|0.0001|TWO_SIDED|95.0|26.08|42.84||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||42.84|26.08|< 0.0001
73946541|NCT02277743|147425366|SUPERIORITY||Least square (LS) mean difference|-24.9|||<|0.0001|TWO_SIDED|95.0|-32.26|-17.52||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-17.52|-32.26|< 0.0001
73946542|NCT02277743|147425366|SUPERIORITY||LS mean difference|-22.8|||<|0.0001|TWO_SIDED|95.0|-30.33|-15.33||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-15.33|-30.33|< 0.0001
73946543|NCT02277743|147425367|SUPERIORITY||difference in percentages|9.8||||0.0012|TWO_SIDED|95.0|3.95|15.71||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||15.71|3.95|0.0012
73946544|NCT02277743|147425367|SUPERIORITY||difference in percentages|17.3|||<|0.0001|TWO_SIDED|95.0|10.57|23.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||23.93|10.57|< 0.0001
73946545|NCT02277743|147425368|SUPERIORITY||difference in percentages|6.1||||0.0097|TWO_SIDED|95.0|1.49|10.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||10.68|1.49|0.0097
73946546|NCT02277743|147425368|SUPERIORITY||difference in percentages|6.2||||0.0094|TWO_SIDED|95.0|1.45|10.86||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||10.86|1.45|0.0094
73946547|NCT02277743|147425369|SUPERIORITY||LS mean difference|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.236|-1.26||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.260|-2.236|< 0.0001
73946548|NCT02277743|147425369|SUPERIORITY||LS mean difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.189|-1.186||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.186|-2.189|< 0.0001
73946549|NCT02277743|147425370|SUPERIORITY||LS mean difference|-34.6|||<|0.0001|TWO_SIDED|95.0|-42.35|-26.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-26.88|-42.35|< 0.0001
73946550|NCT02277743|147425370|SUPERIORITY||LS mean difference|-34.4|||<|0.0001|TWO_SIDED|95.0|-42.17|-26.56||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-26.56|-42.17|< 0.0001
73958349|NCT05046132|147452015|OTHER||LS Mean|-4.1|||||TWO_SIDED|90.0|-7.4|-0.8||||||16 hr Post dose||-0.8|-7.4|
73958350|NCT05046132|147452015|OTHER||LS Mean|-7.1|||||TWO_SIDED|90.0|-10.1|-4.2||||||24 hr Post dose||-4.2|-10.1|
74031968|NCT01984346|147617215|SUPERIORITY||Mean Difference (Net)|16.7||||0.0472|TWO_SIDED|95.0|0.1|33.2||A prior threshold for statistical significance was 0.05|Chi-square test|||||33.2|0.1|0.0472
74031969|NCT02531373|147617227|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-13.5|3.1||||||||3.1|-13.5|
74031970|NCT02531373|147617227|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-16.3|1.2||||||||1.2|-16.3|
73976279|NCT01478594|147498054|SUPERIORITY_OR_OTHER|||||||0.718|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).||||||0.718
73976280|NCT01478594|147498055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.389||||0.437|TWO_SIDED|95.0|0.604|3.194|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||3.194|0.604|0.437
73976281|NCT01478594|147498056|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.006||||0.967|TWO_SIDED|95.0|0.746|1.358|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||1.358|0.746|0.967
73976282|NCT01478594|147498059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.331|||||TWO_SIDED|95.0|0.746|2.375|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.375|0.746|
73976283|NCT01478594|147498059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.575|||||TWO_SIDED|95.0|0.285|1.16|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.160|0.285|
73976284|NCT01478594|147498060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.608|||||TWO_SIDED|95.0|0.635|4.073|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.073|0.635|
74031971|NCT02531373|147617227|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-3.9|||||TWO_SIDED|95.0|-13.3|3.2||||||||3.2|-13.3|
74031972|NCT02531373|147617227|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-1.9|||||TWO_SIDED|95.0|-10.2|5.1||||||||5.1|-10.2|
74031973|NCT02531373|147617228|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.2||||||||7.2|-6.9|
74031974|NCT02531373|147617228|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.2||||||||7.2|-6.9|
74031975|NCT02531373|147617228|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.1||||||||7.1|-6.9|
74031976|NCT02531373|147617228|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|6.9||||||||6.9|-6.9|
73976285|NCT01478594|147498060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755|||||TWO_SIDED|95.0|0.375|1.521|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.521|0.375|
73976286|NCT01478594|147498061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.877|||||TWO_SIDED|95.0|0.366|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.100|0.366|
73976287|NCT01478594|147498061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.275|||||TWO_SIDED|95.0|0.614|2.646|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.646|0.614|
73976288|NCT01478594|147498062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.721|||||TWO_SIDED|95.0|0.345|1.507|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.507|0.345|
73976289|NCT01478594|147498062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.597|||||TWO_SIDED|95.0|0.672|3.795|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.795|0.672|
74031977|NCT02531373|147617229|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|20.3||||0.029|TWO_SIDED|95.0|2.1|37.3|||Miettinen and Nurminen method|||||37.3|2.1|0.029
74031978|NCT02531373|147617229|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|22.3||||0.016|TWO_SIDED|95.0|4.3|39.1|||Miettinen and Nurminen method|||||39.1|4.3|0.016
74031979|NCT02531373|147617229|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|1.1||||0.908|TWO_SIDED|95.0|-17.7|19.9|||Miettinen and Nurminen method|||||19.9|-17.7|0.908
74031980|NCT02531373|147617229|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|23.1||||0.011|TWO_SIDED|95.0|5.4|39.6|||Miettinen and Nurminen method|||||39.6|5.4|0.011
74031981|NCT02531373|147617230|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-0.5||||0.943|TWO_SIDED|95.0|-14.0|12.9|||Miettinen and Nurminen method|||||12.9|-14.0|0.943
74031982|NCT02531373|147617230|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-2.5||||0.711|TWO_SIDED|95.0|-16.4|11.2|||Miettinen and Nurminen method|||||11.2|-16.4|0.711
73946551|NCT02277743|147425371|SUPERIORITY||difference in percentages|44.2|||<|0.0001|TWO_SIDED|95.0|35.91|52.48||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||52.48|35.91|< 0.0001
73946552|NCT02277743|147425371|SUPERIORITY||difference in percentages|36.4|||<|0.0001|TWO_SIDED|95.0|27.9|44.96||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||44.96|27.90|< 0.0001
73946553|NCT02277743|147425372|SUPERIORITY||difference in percentages|28.1|||<|0.0001|TWO_SIDED|95.0|20.96|35.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||35.29|20.96|< 0.0001
73946554|NCT02277743|147425372|SUPERIORITY||difference in percentages|25.6|||<|0.0001|TWO_SIDED|95.0|18.51|32.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||32.68|18.51|< 0.0001
73946555|NCT02277743|147425373|SUPERIORITY||LS mean difference|-17.92|||<|0.0001|TWO_SIDED|95.0|-22.487|-13.353||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-13.353|-22.487|< 0.0001
73946556|NCT02277743|147425373|SUPERIORITY||LS mean difference|-18.89|||<|0.0001|TWO_SIDED|95.0|-23.125|-14.65||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-14.650|-23.125|< 0.0001
73946557|NCT02277743|147425374|SUPERIORITY||LS mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.79|-21.54||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-21.54|-35.79|< 0.0001
73946558|NCT02277743|147425374|SUPERIORITY||LS mean difference|-28.0|||<|0.0001|TWO_SIDED|95.0|-35.09|-20.87||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-20.87|-35.09|< 0.0001
73946559|NCT02277743|147425375|SUPERIORITY||LS mean difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.16|-2.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-2.80|-5.16|< 0.0001
73946560|NCT02277743|147425375|SUPERIORITY||LS mean difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.87|-2.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-2.49|-4.87|< 0.0001
73946561|NCT02277743|147425376|SUPERIORITY||LS mean difference|-6.5|||<|0.0001|TWO_SIDED|95.0|-8.02|-5.01||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-5.01|-8.02|< 0.0001
73946562|NCT02277743|147425376|SUPERIORITY||LS mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.44|-4.32||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-4.32|-7.44|< 0.0001
73946563|NCT02277743|147425377|SUPERIORITY||LS mean difference|-2.2||||0.0006|TWO_SIDED|95.0|-3.44|-0.95||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-0.95|-3.44|0.0006
73946564|NCT02277743|147425377|SUPERIORITY||LS mean difference|-2.2||||0.0003|TWO_SIDED|95.0|-3.46|-1.03||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.03|-3.46|0.0003
73946565|NCT02277743|147425378|SUPERIORITY||LS mean difference|-27.0|||<|0.0001|TWO_SIDED|95.0|-35.04|-18.91||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-18.91|-35.04|< 0.0001
73946566|NCT02277743|147425378|SUPERIORITY||LS mean difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-33.06|-18.12||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-18.12|-33.06|< 0.0001
73946567|NCT02277743|147425379|SUPERIORITY||LS mean difference|-16.5|||<|0.0001|TWO_SIDED|95.0|-21.08|-11.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-11.90|-21.08|< 0.0001
73946568|NCT02277743|147425379|SUPERIORITY||LS mean difference|-15.1|||<|0.0001|TWO_SIDED|95.0|-19.62|-10.5||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-10.50|-19.62|< 0.0001
73946569|NCT03976466|147425412|SUPERIORITY||Risk Ratio (RR)|0.049|||<|0.05|TWO_SIDED|95.0|0.015|0.168|||Chi-squared, Corrected||For the Relative risk the control Study group was the numerator and control group denominator. In the 2X2 contingency table the rows correspond to groups and columns for the presence or abscence of periprosthetic infection.|"H0.- There is no significant difference in the incidence of periprosthetic infection in patients with non-modifiable risk factors and prophylactic application of antibiotic loaded calcium sulfate compared with patients without prophylactic treatment with calcium sulfate.~The presence of periprosthetic infection in both groups was evaluated by chi2 and Lambda tests for dichotomous nominal and qualitative variables with longitudinal direction and relative risk factor test."||0.168|0.015|<0.05
73958351|NCT05046132|147452015|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-2.0|4.2||||||Pre dose||4.2|-2.0|
73958352|NCT05046132|147452015|OTHER||LS Mean|3.1|||||TWO_SIDED|90.0|-0.1|6.3||||||0.5 hr Post dose||6.3|-0.1|
73976290|NCT01478594|147498063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.627|||||TWO_SIDED|95.0|0.58|4.564|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.564|0.580|
73946570|NCT03976466|147425413|SUPERIORITY||||||<|0.01||||||The statistical test of t was performed for the variable length of hospital stay, finding a significant difference with a p value \< 0.01|t-test, 2 sided|||Lenght of stay was the variable that compares both groups and was a continous variable (t-test).||||<0.01
73946571|NCT01557322|147425414|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Morning Stiffness \> 1 Hour: p-value was calculated using chi-square test.||||0.010
73946572|NCT01557322|147425414|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Arthritis or Deformity of 3 or More Joint Areas: p-value was calculated using chi-square test.||||<0.001
73946573|NCT01557322|147425414|SUPERIORITY_OR_OTHER|||||||0.363|TWO_SIDED||||||Chi-squared|||Arthritis/Deformity of Hand/Joint: p-value was calculated using chi-square test.||||0.363
73946574|NCT01557322|147425414|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Symmetry: p-value was calculated using chi-square test.||||<0.001
73946575|NCT01557322|147425414|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Nodules: p-value was calculated using chi-square test.||||<0.001
73946576|NCT01557322|147425414|SUPERIORITY_OR_OTHER|||||||0.605|TWO_SIDED||||||Chi-squared|||Rheumatoid Factor Positive: p-value was calculated using chi-square test.||||0.605
73946577|NCT01557322|147425414|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Chi-squared|||Erosions on Hand or Feet X-Ray: p-value was calculated using chi-square test.||||0.038
73946578|NCT01557322|147425415|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Sicca Syndrome: p-value was calculated using chi-square test.||||<0.001
73976291|NCT01478594|147498063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.779|||||TWO_SIDED|95.0|0.397|1.531|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.531|0.397|
73946579|NCT01557322|147425415|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||Serosal Involvement: p-value was calculated using chi-square test.||||0.024
74031983|NCT02531373|147617230|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|3.7||||0.529|TWO_SIDED|95.0|-8.7|16.4|||Miettinen and Nurminen method|||||16.4|-8.7|0.529
74031984|NCT02531373|147617230|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|5.8||||0.298|TWO_SIDED|95.0|-5.8|18.2|||Miettinen and Nurminen method|||||18.2|-5.8|0.298
73946580|NCT01557322|147425415|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED||||||Chi-squared|||Eye Involvement: p-value was calculated using chi-square test.||||0.257
73976292|NCT01478594|147498064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.946|||||TWO_SIDED|95.0|0.636|5.956|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||5.956|0.636|
74031985|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.61|1.1||||||Serotype 1||1.10|0.61|
73946581|NCT01557322|147425415|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||Systemic Vasculitis: p-value was calculated using chi-square test.||||0.026
73946582|NCT01557322|147425415|SUPERIORITY_OR_OTHER|||||||0.725|TWO_SIDED||||||Chi-squared|||Nailfold Vasculitis: p-value was calculated using chi-square test.||||0.725
73946583|NCT01557322|147425415|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Chi-squared|||Pulmonary Fibrosis: p-value was calculated using chi-square test.||||0.220
73946584|NCT01557322|147425415|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Chi-squared|||Other: p-value was calculated using chi-square test.||||0.620
73946585|NCT01557322|147425416|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Knee Replacement: p-value was calculated using chi-square test.||||<0.001
73946586|NCT01557322|147425416|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Hip Replacement: p-value was calculated using chi-square test.||||<0.001
73946587|NCT01557322|147425416|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Shoulder Replacement: p-value was calculated using chi-square test.||||<0.001
73946588|NCT01557322|147425416|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Elbow Replacement: p-value was calculated using chi-square test.||||<0.001
73946589|NCT01557322|147425416|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||Wrist/Hand/Ankle/Foot Surgery: p-value was calculated using chi-square test.||||0.001
73946590|NCT01557322|147425416|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Neck Surgery: p-value was calculated using chi-square test.||||<0.001
73946591|NCT01557322|147425417|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||P-value was calculated using chi-square test.||||<0.001
73946592|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Chi-squared|||High Blood Pressure: p-value was calculated using chi-square test.||||0.381
73946593|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Chi-squared|||Angina: p-value was calculated using chi-square test.||||0.006
73946594|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED||||||Chi-squared|||Heart Attack: p-value was calculated using chi-square test.||||0.215
73946595|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.117|TWO_SIDED||||||Chi-squared|||Stroke: p-value was calculated using chi-square test.||||0.117
73946596|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Epilepsy: p-value was calculated using chi-square test.||||1.000
73946597|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.542|TWO_SIDED||||||Chi-squared|||Asthma: p-value was calculated using chi-square test.||||0.542
73946598|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||Chi-squared|||Chronic Bronchitis/Emphysema: p-value was calculated using chi-square test.||||0.027
73946599|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED||||||Chi-squared|||Peptic Ulcer: p-value was calculated using chi-square test.||||0.566
74031986|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.77|||||TWO_SIDED|95.0|1.33|2.35||||||Serotype 3||2.35|1.33|
74031987|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.91|1.81||||||Serotype 4||1.81|0.91|
74031988|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.59|1.51||||||Serotype 5||1.51|0.59|
73870050|NCT00635882|147284095|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||"Analysis of covariance (ANCOVA) model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||<0.001
73870051|NCT00635882|147284095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.003
73870052|NCT00635882|147284095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.018
73946600|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||Liver Disease: p-value was calculated using chi-square test.||||0.003
73946601|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.526|TWO_SIDED||||||Chi-squared|||Renal Disease: p-value was calculated using chi-square test.||||0.526
73946602|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.802|TWO_SIDED||||||Chi-squared|||Tuberculosis: p-value was calculated using chi-square test.||||0.802
73946603|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Demyelination: p-value was calculated using chi-square test.||||1.000
73946604|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.385|TWO_SIDED||||||Chi-squared|||Diabetes: p-value was calculated using chi-square test.||||0.385
73976293|NCT01478594|147498064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.806|||||TWO_SIDED|95.0|0.422|1.538|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.538|0.422|
73976294|NCT01478594|147498065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.776|||||TWO_SIDED|95.0|0.303|1.991|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.991|0.303|
73976295|NCT01478594|147498065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|||||TWO_SIDED|95.0|0.615|2.501|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.501|0.615|
73976296|NCT01478594|147498066|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.343|2.63|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.630|0.343|
74031989|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.5||||||95.0|0.29|0.86||||||Serotype 6A||0.86|0.29|
73870053|NCT00635882|147284096|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||<0.001
73870054|NCT00635882|147284096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.002
73870055|NCT00635882|147284096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.002
73870056|NCT00635882|147284097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.024
73870057|NCT00635882|147284097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.051
73870058|NCT00635882|147284097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.336|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.336
73870059|NCT00635882|147284098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.120
73946605|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Chi-squared|||Hyperthyroidism: p-value was calculated using chi-square test.||||0.048
73946606|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||Chi-squared|||Depression: p-value was calculated using chi-square test.||||0.308
73946607|NCT01557322|147425418|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|||Cancer: p-value was calculated using chi-square test.||||0.033
73946608|NCT01557322|147425419|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||0.188
73946609|NCT01557322|147425420|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||Systolic Blood Pressure: p-value was calculated using 2-sided t-test.||||0.016
73946610|NCT01557322|147425420|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||t-test, 2 sided|||Diastolic Blood Pressure: p-value was calculated using 2-sided t-test.||||0.369
73946611|NCT01557322|147425421|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
73946612|NCT01557322|147425421|SUPERIORITY_OR_OTHER|||||||0.3746|TWO_SIDED||||||Regression, Linear|||Change at Month 60: p-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.3746
73976297|NCT01478594|147498066|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.983|||||TWO_SIDED|95.0|0.503|1.918|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.918|0.503|
74031990|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.58|2.1||||||Serotype 6B||2.10|0.58|
73946613|NCT01557322|147425422|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
73946614|NCT01557322|147425423|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
73946615|NCT01557322|147425424|SUPERIORITY_OR_OTHER|||||||0.154|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.154
73946616|NCT01557322|147425425|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.108
73946617|NCT01557322|147425426|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.199
73946618|NCT01557322|147425427|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||<0.001
73946619|NCT01557322|147425428|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||<0.001
73976298|NCT01478594|147498067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.226|||||TWO_SIDED|95.0|0.468|3.214|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.214|0.468|
73976299|NCT01478594|147498067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232|||||TWO_SIDED|95.0|0.447|3.396|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.396|0.447|
73976300|NCT01478594|147498068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.803|||||TWO_SIDED|95.0|0.307|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.100|0.307|
74031991|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.55|1.03||||||Serotype 7F||1.03|0.55|
73946620|NCT01557322|147425430|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Current DMARDs, Methotrexate: p-value was calculated using chi-square test.||||<0.001
73946621|NCT01557322|147425430|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||Current DMARDs, Azathioprine: p-value was calculated using chi-square test.||||0.313
73946622|NCT01557322|147425430|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Current DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.||||1.000
73946623|NCT01557322|147425430|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Chi-squared|||Current DMARDs, Cyclosporine: p-value was calculated using chi-square test.||||0.066
73946624|NCT01557322|147425430|SUPERIORITY_OR_OTHER|||||||0.099|TWO_SIDED||||||Chi-squared|||Current DMARDs, Leflunomide: p-value was calculated using chi-square test.||||0.099
73946625|NCT01557322|147425430|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Current DMARDs, Sulphasalazine: p-value was calculated using chi-square test.||||<0.001
73946626|NCT01557322|147425430|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Methotrexate: p-value was calculated using chi-square test.||||<0.001
73946627|NCT01557322|147425430|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Azathioprine: p-value was calculated using chi-square test.||||<0.001
73946628|NCT01557322|147425430|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.||||<0.001
73946629|NCT01557322|147425430|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Cyclosporine: p-value was calculated using chi-square test.||||<0.001
73946630|NCT01557322|147425430|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Leflunomide: p-value was calculated using chi-square test.||||<0.001
73946631|NCT01557322|147425431|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
73946632|NCT01557322|147425432|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline PCS: p-value was calculated using 2-sided t-test.||||<0.001
73946633|NCT01557322|147425432|SUPERIORITY_OR_OTHER|||||||0.886|TWO_SIDED||||||t-test, 2 sided|||Baseline MCS: p-value was calculated using 2-sided t-test.||||0.886
73946634|NCT01557322|147425432|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||t-test, 2 sided|||Baseline Vitality Score: p-value was calculated using 2-sided t-test.||||0.680
73946635|NCT01557322|147425442|SUPERIORITY_OR_OTHER|||||||0.0233|TWO_SIDED||||||Chi-squared|||Month 6: p-value was calculated using chi-square test.||||0.0233
73946636|NCT01557322|147425442|SUPERIORITY_OR_OTHER|||||||0.5103|TWO_SIDED||||||Chi-squared|||Month 12: p-value was calculated using chi-square test.||||0.5103
73946637|NCT01557322|147425442|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||Chi-squared|||Month 18: p-value was calculated using chi-square test.||||0.9990
73946638|NCT01557322|147425442|SUPERIORITY_OR_OTHER|||||||0.6495|TWO_SIDED||||||Chi-squared|||Month 24: p-value was calculated using chi-square test.||||0.6495
73946639|NCT01557322|147425442|SUPERIORITY_OR_OTHER|||||||0.3829|TWO_SIDED||||||Chi-squared|||Month 30: p-value was calculated using chi-square test.||||0.3829
73946640|NCT01557322|147425442|SUPERIORITY_OR_OTHER|||||||0.1085|TWO_SIDED||||||Chi-squared|||Month 36: p-value was calculated using chi-square test.||||0.1085
74031992|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.74|1.75||||||Serotype 9V||1.75|0.74|
74031993|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.58|1.27||||||Serotype 14||1.27|0.58|
74031994|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.63||||||95.0|0.43|0.92||||||Serotype 18C||0.92|0.43|
73946641|NCT01557322|147425442|SUPERIORITY_OR_OTHER|||||||0.0472|TWO_SIDED||||||Chi-squared|||Month 48: p-value was calculated using chi-square test.||||0.0472
73946642|NCT01557322|147425442|SUPERIORITY_OR_OTHER|||||||0.4804|TWO_SIDED||||||Chi-squared|||Month 60: p-value was calculated using chi-square test.||||0.4804
73946643|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.0895|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 6: p-value was calculated using chi-square test.||||0.0895
73946644|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.0774|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 12: p-value was calculated using chi-square test.||||0.0774
73946645|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 18: p-value was calculated using chi-square test.||||0.0024
73946646|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.5552|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 30: p-value was calculated using chi-square test.||||0.5552
73976301|NCT01478594|147498068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.505|||||TWO_SIDED|95.0|0.585|3.873|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.873|0.585|
73976302|NCT01478594|147498069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.356|2.385|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.385|0.356|
73976303|NCT01478594|147498069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|0.462|3.22|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.220|0.462|
73976304|NCT01478594|147498070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.915|||||TWO_SIDED|95.0|0.334|2.512|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.512|0.334|
73976305|NCT01478594|147498070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.384|||||TWO_SIDED|95.0|0.554|3.455|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.455|0.554|
73976306|NCT01478594|147498071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.538|||||TWO_SIDED|95.0|0.548|4.32|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.320|0.548|
73976307|NCT01478594|147498071|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.744|||||TWO_SIDED|95.0|0.299|1.85|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.850|0.299|
73946647|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.0793|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 36: p-value was calculated using chi-square test.||||0.0793
73946648|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 48: p-value was calculated using chi-square test.||||0.0075
73946649|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.0895|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 6: p-value was calculated using chi-square test.||||0.0895
73946650|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 18: p-value was calculated using chi-square test.||||0.0024
73946651|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.6301|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 30: p-value was calculated using chi-square test.||||0.6301
73946652|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.0793|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 36: p-value was calculated using chi-square test.||||0.0793
73946653|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 48: p-value was calculated using chi-square test.||||0.0075
73946654|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.7253|TWO_SIDED||||||Chi-squared|||Myeloma, Month 12: p-value was calculated using chi-square test.||||0.7253
73946655|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.7336|TWO_SIDED||||||Chi-squared|||Myeloma, Month 30: p-value was calculated using chi-square test.||||0.7336
73946656|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.0044|TWO_SIDED||||||Chi-squared|||Leukaemia, Month 12: p-value was calculated using chi-square test.||||0.0044
73946657|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.4175|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 6: p-value was calculated using chi-square test.||||0.4175
73946658|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.3886|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 12: p-value was calculated using chi-square test.||||0.3886
73946659|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.5102|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 18: p-value was calculated using chi-square test.||||0.5102
73946660|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.9855|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 24: p-value was calculated using chi-square test.||||0.9855
73976308|NCT05230433|147498086|OTHER||Percent Consumed|86.0||||0.15|TWO_SIDED|||||p-value was not adjusted for multiple comparisons|Chi-squared|||High fat agents were weighed pre- and post- providing the shake to the participant. All containers were tared to take into account straw, lid, and glass weight. Percentage of high-fat challenge consumed was calculated by post-shake weight / pre-shake weight. 13 out of 15 partcipants drank \>75% of the shake.||||0.15
74031995|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.64|1.26||||||Serotype 19A||1.26|0.64|
73946661|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.4955|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 30: p-value was calculated using chi-square test.||||0.4955
73946662|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.5404|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 36: p-value was calculated using chi-square test.||||0.5404
73946663|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.3581|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 48: p-value was calculated using chi-square test.||||0.3581
73946664|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.4932|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 6: p-value was calculated using chi-square test.||||0.4932
73946665|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.4818|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 12: p-value was calculated using chi-square test.||||0.4818
74031996|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.62|1.11||||||Serotype 19F||1.11|0.62|
74031997|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|81.47|||||TWO_SIDED|95.0|60.51|109.68||||||Serotype 22F (non-Prevnar serotype)||109.68|60.51|
74031998|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.56|1.47||||||Serotype 23F||1.47|0.56|
74031999|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|22.23|||||TWO_SIDED|95.0|11.77|41.97||||||Serotype 33F (non-Prevnar serotype)||41.97|11.77|
73946666|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.3224|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 18: p-value was calculated using chi-square test.||||0.3224
73946667|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.5003|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 24: p-value was calculated using chi-square test.||||0.5003
73946668|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.1134|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 30: p-value was calculated using chi-square test.||||0.1134
73946669|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.3488|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 36: p-value was calculated using chi-square test.||||0.3488
73946670|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 48: p-value was calculated using chi-square test.||||0.1870
73946671|NCT01557322|147425443|SUPERIORITY_OR_OTHER|||||||0.427|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 60: p-value was calculated using chi-square test.||||0.4270
73946672|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.5817|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 6: p-value was calculated using chi-square test.||||0.5817
73946673|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.2595|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 12: p-value was calculated using chi-square test.||||0.2595
73946674|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.5642|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 18: p-value was calculated using chi-square test.||||0.5642
73946675|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 24: p-value was calculated using chi-square test.||||0.0034
73946676|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.7137|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 36: p-value was calculated using chi-square test.||||0.7137
73946677|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.963|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 60: p-value was calculated using chi-square test.||||0.9630
73958353|NCT05046132|147452015|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-0.1|4.9||||||1 hr Post dose||4.9|-0.1|
73958354|NCT05046132|147452015|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|0.2|5.8||||||1.5 hr Post dose||5.8|0.2|
73958355|NCT05046132|147452015|OTHER||LS Mean|1.8|||||TWO_SIDED|90.0|-1.0|4.6||||||2 hr Post dose||4.6|-1.0|
73958356|NCT05046132|147452015|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.9|3.1||||||2.5 hr Post dose||3.1|-1.9|
73958357|NCT05046132|147452015|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.0|4.8||||||3 hr Post dose||4.8|-1.0|
73958358|NCT05046132|147452015|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-3.5|3.0||||||4 hr Post dose||3.0|-3.5|
73958359|NCT05046132|147452015|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.6|3.2||||||5 hr Post dose||3.2|-2.6|
73958360|NCT05046132|147452015|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-4.8|1.1||||||6 hr Post dose||1.1|-4.8|
73958361|NCT05046132|147452015|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-3.8|1.7||||||7 hr Post dose||1.7|-3.8|
73958362|NCT05046132|147452015|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-3.6|2.6||||||8 hr Post dose||2.6|-3.6|
73958363|NCT05046132|147452015|OTHER||LS Mean|-2.7|||||TWO_SIDED|90.0|-5.6|0.2||||||9 hr Post dose||0.2|-5.6|
73958364|NCT05046132|147452015|OTHER||LS Mean|-3.5|||||TWO_SIDED|90.0|-6.8|-0.2||||||10 hr Post dose||-0.2|-6.8|
73958365|NCT05046132|147452015|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.6|0.1||||||12 hr Post dose||0.1|-6.6|
73958366|NCT05046132|147452015|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.0|3.6||||||16 hr Post dose||3.6|-3.0|
73958367|NCT05046132|147452015|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.0|2.9||||||24 hr Post dose||2.9|-3.0|
73958368|NCT05046132|147452016|OTHER||LS Mean|-6.6|||||TWO_SIDED|90.0|-10.3|-3.0||||||Pre dose||-3.0|-10.3|
73958369|NCT05046132|147452016|OTHER||LS Mean|-7.3|||||TWO_SIDED|90.0|-10.5|-4.0||||||0.5 hr Post dose||-4.0|-10.5|
73958370|NCT05046132|147452016|OTHER||LS Mean|-5.0|||||TWO_SIDED|90.0|-8.8|-1.2||||||1 hr Post dose||-1.2|-8.8|
73958371|NCT05046132|147452016|OTHER||LS Mean|-5.0|||||TWO_SIDED|90.0|-8.4|-1.6||||||1.5 hr Post dose||-1.6|-8.4|
73958372|NCT05046132|147452016|OTHER||LS Mean|-3.5|||||TWO_SIDED|90.0|-6.6|-0.3||||||2 hr Post dose||-0.3|-6.6|
73958373|NCT05046132|147452016|OTHER||LS Mean|-2.9|||||TWO_SIDED|90.0|-6.1|0.3||||||2.5 hr Post dose||0.3|-6.1|
73958374|NCT05046132|147452016|OTHER||LS Mean|-4.6|||||TWO_SIDED|90.0|-7.7|-1.5||||||3 hr Post dose||-1.5|-7.7|
73958375|NCT05046132|147452016|OTHER||LS Mean|-7.1|||||TWO_SIDED|90.0|-10.3|-3.8||||||4 hr Post dose||-3.8|-10.3|
73958376|NCT05046132|147452016|OTHER||LS Mean|-3.2|||||TWO_SIDED|90.0|-6.9|0.6||||||5 hr Post dose||0.6|-6.9|
73958377|NCT05046132|147452016|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.8|-0.6||||||6 hr Post dose||-0.6|-7.8|
73958378|NCT05046132|147452016|OTHER||LS Mean|-4.8|||||TWO_SIDED|90.0|-8.1|-1.6||||||7 hr Post dose||-1.6|-8.1|
73958379|NCT05046132|147452016|OTHER||LS Mean|-4.4|||||TWO_SIDED|90.0|-7.8|-1.1||||||8 hr Post dose||-1.1|-7.8|
73958380|NCT05046132|147452016|OTHER||LS Mean|-5.9|||||TWO_SIDED|90.0|-9.3|-2.6||||||9 hr Post dose||-2.6|-9.3|
73958381|NCT05046132|147452016|OTHER||LS Mean|-4.4|||||TWO_SIDED|90.0|-7.8|-1.1||||||10 hr Post dose||-1.1|-7.8|
73958382|NCT05046132|147452016|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.3|-1.1||||||12 hr Post dose||-1.1|-7.3|
73958383|NCT05046132|147452016|OTHER||LS Mean|-5.8|||||TWO_SIDED|90.0|-9.7|-2.0||||||16 hr Post dose||-2.0|-9.7|
73946678|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.7353|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 6: p-value was calculated using chi-square test.||||0.7353
73946679|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.3829|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 12: p-value was calculated using chi-square test.||||0.3829
73946680|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.4532|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 18: p-value was calculated using chi-square test.||||0.4532
73946681|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.4238|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 24: p-value was calculated using chi-square test.||||0.4238
73946682|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.1218|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 30: p-value was calculated using chi-square test.||||0.1218
73946683|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.4124|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 36: p-value was calculated using chi-square test.||||0.4124
73946684|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.6356|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 48: p-value was calculated using chi-square test.||||0.6356
73946685|NCT01557322|147425444|SUPERIORITY_OR_OTHER|||||||0.5491|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 60: p-value was calculated using chi-square test.||||0.5491
74009065|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.97||0.11|TWO_SIDED|80.0|0.33|2.88|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.88|0.33|0.110
73946686|NCT01557322|147425445|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||<0.0001
73946687|NCT01557322|147425446|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline HAQ-DI score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||<0.0001
73946688|NCT01557322|147425447|SUPERIORITY_OR_OTHER|||||||0.2558|TWO_SIDED||||||Regression, Linear|||PCS: p-value was calculated using multivariate linear regression with baseline PCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.2558
73946689|NCT01557322|147425447|SUPERIORITY_OR_OTHER|||||||0.4908|TWO_SIDED||||||Regression, Linear|||MCS: p-value was calculated using multivariate linear regression with baseline MCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.4908
73946690|NCT01557322|147425447|SUPERIORITY_OR_OTHER|||||||0.8379|TWO_SIDED||||||Regression, Linear|||Vitality Score: p-value was calculated using multivariate linear regression with baseline vitality score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.8379
73946691|NCT02247336|147425449|SUPERIORITY||Odds Ratio (OR)|0.7||||0.16|TWO_SIDED|95.0|0.4|1.2||A priori threshold was 0.05.|Regression, Logistic|generalized estimating equation|Generalized estimating equation models were used with a logit link function and an exchangeable correlation structure to account for clustering of participants within provider. Fay and Graubard small sample bias correction was applied.|Using alpha=0.05, 80% power, and a risk-appropriate screening referral rate for the delayed arm ranging from 60% to 70%, n = 250 participants with a completed a family health history assessment per arm with 40 providers was needed to detect differences between arms in appropriate referral ranging from 12% to 13.2%. Sample size calculations accounted for provider clustering using an intra-class correlation coefficient of 0.02 to adjust variance for a Z-test of the difference of two proportions.||1.2|0.4|0.16
74032000|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.68|1.23||||||Serotype 1||1.23|0.68|
74032001|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|2.11|||||TWO_SIDED|95.0|1.6|2.8||||||Serotype 3||2.80|1.60|
74032002|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.82|1.62||||||Serotype 4||1.62|0.82|
74032003|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.53|1.31||||||Serotype 5||1.31|0.53|
74032004|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.54|||||TWO_SIDED|95.0|0.31|0.92||||||Serotype 6A||0.92|0.31|
74032005|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.42|1.5||||||Serotype 6B||1.50|0.42|
74032006|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.71|1.31||||||Serotype 7F||1.31|0.71|
74032007|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.64|1.49||||||Serotype 9V||1.49|0.64|
74032008|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.63|1.37||||||Serotype 14||1.37|0.63|
73976309|NCT05230433|147498087|OTHER|No test vs. control groups.||||||0.65||||||This p-value is not adjusted for multiple comparisons.|Pearson Correlation|||Fold change from 60 to 180 minutes of average medium chain acylcarnitine was calculated for each participant. Pearson correlation between BMI percentile and fold change was calculated.|Pearson Correlation between both secondary outcomes reported: BMI percentile and fold change between acylcarnitine at 60 minutes and 180 minutes post the high fat challenge.|||0.65
73976310|NCT04732000|147498105|OTHER||Median Difference (Final Values)|-0.1373||||0.549|TWO_SIDED|||||The a priori threshold for statistical significance is \< 0.05.|Mann Whitney test, 2-sided|||||||0.5490
73976311|NCT04250194|147498113|NON_INFERIORITY|The noninferiority margin was 10%.|absolute difference in percentage points|5.4||||0.003|TWO_SIDED|95.0|-6.5|17.2||The threshold for statistical significance was p = 0.05. The p value was not adjusted for multiple comparisons.|One-sided two-sample z-test||Difference in diagnostic accuracy = navigational bronchoscopy % - transthoracic biopsy %|||17.2|-6.5|0.003
73976312|NCT03542305|147498166|OTHER||Ratio (%) of Adjusted Geometric Means|104.25|||||TWO_SIDED|90.0|79.73|136.31|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Mild renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||136.31|79.73|
73976313|NCT03542305|147498166|OTHER||Ratio (%) of Adjusted Geometric Means|118.75|||||TWO_SIDED|90.0|91.43|154.24|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Moderate renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||154.24|91.43|
73976314|NCT03542305|147498166|OTHER||Ratio (%) of Adjusted Geometric Means|141.14|||||TWO_SIDED|90.0|97.82|203.66|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Severe renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||203.66|97.82|
73976315|NCT03542305|147498167|OTHER||Ratio (%) of Adjusted Geometric Means|100.53|||||TWO_SIDED|90.0|66.48|152.02|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Mild renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||152.02|66.48|
73976316|NCT03542305|147498167|OTHER||Slope|88.87|||||TWO_SIDED|90.0|64.18|123.06|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Moderate renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||123.06|64.18|
73976317|NCT03542305|147498167|OTHER||Ratio (%) of Adjusted Geometric Means|92.32|||||TWO_SIDED|90.0|56.58|150.63|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Severe renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||150.63|56.58|
74009066|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.993||0.461|TWO_SIDED|80.0|-0.56|2.05|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.05|-0.56|0.461
73870060|NCT00635882|147284098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.103
73870061|NCT00635882|147284098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.048
74032009|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.55|1.16||||||Serotype 18C||1.16|0.55|
73870062|NCT00635882|147284099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way analysis of variance (ANOVA) model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.018
73870063|NCT00635882|147284099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.261|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.261
73870064|NCT00635882|147284099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.334|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.334
73870065|NCT00635882|147284100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.037
73946692|NCT02247336|147425450|SUPERIORITY||Odds Ratio (OR)|0.7||||0.23|TWO_SIDED|95.0|0.04|1.2||The a priori threshold was 0.05.|Regression, Logistic|generalized estimating equation|Generalized estimating equation models were used with a logit link function and an exchangeable correlation structure to account for clustering of participants within provider. Fay and Graubard small sample bias correction was applied.|||1.2|.04|0.23
74032010|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.63|1.22||||||Serotype 19A||1.22|0.63|
74032011|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.81|1.44||||||Serotype 19F||1.44|0.81|
74032012|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|89.87|||||TWO_SIDED|95.0|67.02|120.51||||||Serotype 22F (non-Prevnar serotype)||120.51|67.02|
73870066|NCT00635882|147284100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.643|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.643
73870067|NCT00635882|147284100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.963|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.963
73870068|NCT00635882|147284101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
73870069|NCT00635882|147284101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.002
73870070|NCT00635882|147284101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
73870071|NCT00635882|147284102|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
73870072|NCT00635882|147284102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.057
73870073|NCT00635882|147284102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.005
73870074|NCT00825812|147284104|SUPERIORITY_OR_OTHER||ratio of geometric mean time to recovery|5.7||||||95.0|4.9|6.6|||ANOVA|ANOVA, adjusted for center effects, on log transformed times from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.|Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|The primary analysis was the comparison of the two treatments among Chinese subjects.||6.6|4.9|
73870075|NCT00825812|147284104|SUPERIORITY_OR_OTHER||ratio of geometric mean time to recovery|4.8||||||97.5|3.7|6.0|||ANOVA|ANOVA, adjusted for center effects, on log transformed times from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.|Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|A key secondary analysis was the comparison of the two treatments among Caucasian subjects.||6.0|3.7|
73870076|NCT00825812|147284104|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was considered if the 97.5% confidence interval (CI) for median difference in recovery time (T4/T1 ratio to 0.9) was within the pre-specified range of -60 to +60 seconds.|median difference (seconds)|7.0||||||97.5|-5.0|21.0|||||Estimated median difference (Chinese - Caucasian) in seconds for the time to recovery of the T4/T1 ratio to 0.9 (after sugammadex).|A key secondary analysis was the comparison for equivalence between Chinese subjects and Caucasian subjects.||21|-5|
73946693|NCT00733499|147425452|OTHER|||||||0.9478|||||||t-test, 2 sided|||||||0.9478
74032013|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.61|1.57||||||Serotype 23F||1.57|0.61|
74032014|NCT02531373|147617231|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|18.38|||||TWO_SIDED|95.0|9.82|34.41||||||Serotype 33F (non-Prevnar serotype)||34.41|9.82|
74032015|NCT02389816|147617254|SUPERIORITY||Least square (LS) mean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.999||0.008|TWO_SIDED|95.0|-4.63|-0.7|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||||-0.70|-4.63|0.0080
73946694|NCT00733499|147425453|OTHER|||||||0.549|||||||t-test, 2 sided|||||||0.5490
73946695|NCT00733499|147425454|OTHER|||||||0.5312|||||||t-test, 2 sided|||||||0.5312
73946696|NCT00733499|147425455|OTHER|||||||0.3549|||||||t-test, 2 sided|||||||0.3549
73946697|NCT00733499|147425456|OTHER|||||||0.0513|||||||t-test, 2 sided|||||||0.0513
73946698|NCT00733499|147425457|OTHER|||||||0.0629|||||||t-test, 2 sided|||||||0.0629
73946699|NCT00733499|147425458|OTHER|||||||0.0327|||||||t-test, 2 sided|||||||0.0327
73946700|NCT00733499|147425459|OTHER|||||||0.0883|||||||t-test, 2 sided|||||||0.0883
73946701|NCT00733499|147425460|OTHER|||||||0.6801|||||||Wilcoxon (Mann-Whitney)|||||||0.6801
73946702|NCT00733499|147425461|OTHER|||||||0.4779|||||||t-test, 2 sided|||||||0.4779
73946703|NCT00733499|147425462|OTHER|||||||0.8007|||||||t-test, 2 sided|||||||0.8007
73946704|NCT00733499|147425463|OTHER|||||||0.3317|||||||t-test, 2 sided|||||||0.3317
73946705|NCT00733499|147425464|OTHER|||||||0.8955|||||||t-test, 2 sided|||||||0.8955
73946706|NCT00733499|147425465|OTHER|||||||0.2116|||||||t-test, 2 sided|||||||0.2116
73946707|NCT00733499|147425466|OTHER|||||||0.4776|||||||t-test, 2 sided|||||||0.4776
73946708|NCT00733499|147425468|OTHER|||||||0.2935|||||||t-test, 2 sided|||||||0.2935
73946709|NCT00733499|147425469|OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||||||0.0062
73946710|NCT00733499|147425470|OTHER|||||||0.6896|||||||t-test, 2 sided|||||||0.6896
73946711|NCT00733499|147425471|OTHER|||||||0.1076|||||||t-test, 2 sided|||||||0.1076
73946712|NCT00733499|147425472|OTHER|||||||0.9042|||||||t-test, 2 sided|||||||0.9042
73946713|NCT00733499|147425473|OTHER|||||||0.9637|||||||t-test, 2 sided|||||||0.9637
73946714|NCT00733499|147425474|OTHER|||||||0.0485|||||||t-test, 2 sided|||||||0.0485
73946715|NCT00733499|147425475|OTHER|||||||0.9813|||||||t-test, 2 sided|||||||0.9813
73946716|NCT02296190|147425501|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Statistical analysis was performed with the Fisher's exact test to compare the conversion rate between the MSP-2017 groups and the placebo group.||||<0.05
73946717|NCT00717314|147425502|SUPERIORITY_OR_OTHER|||||||0.494|||||||ANOVA|||||||0.494
73946718|NCT00717314|147425505|SUPERIORITY_OR_OTHER|||||||0.374|||||||ANOVA|||Between group comparison at Baseline||||0.374
73946719|NCT00717314|147425505|SUPERIORITY_OR_OTHER|||||||0.685||||||Analysis of covariance (ANCOVA) model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 16||||0.685
73946720|NCT00717314|147425505|SUPERIORITY_OR_OTHER|||||||0.722||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 28||||0.722
73946721|NCT00717314|147425505|SUPERIORITY_OR_OTHER|||||||0.432||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 40||||0.432
73946722|NCT00717314|147425506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-5.342|5.561||||||||5.561|-5.342|
73946723|NCT00717314|147425507|SUPERIORITY_OR_OTHER|||||||0.616||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 16||||0.616
73946724|NCT00717314|147425507|SUPERIORITY_OR_OTHER|||||||0.334||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 28||||0.334
73946725|NCT00717314|147425507|SUPERIORITY_OR_OTHER|||||||0.267||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 40||||0.267
73946726|NCT00717314|147425507|SUPERIORITY_OR_OTHER|||||||0.764|||||||ANCOVA|ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.||Change from Baseline at Week 52||||0.764
73946727|NCT00717314|147425508|SUPERIORITY_OR_OTHER|||||||1|||||||ANCOVA|||||||1.000
73958384|NCT05046132|147452016|OTHER||LS Mean|-8.2|||||TWO_SIDED|90.0|-12.5|-3.8||||||24 hr Post dose||-3.8|-12.5|
73958385|NCT05046132|147452016|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-1.2|5.9||||||Pre dose||5.9|-1.2|
73958386|NCT05046132|147452016|OTHER||LS Mean|-1.4|||||TWO_SIDED|90.0|-4.5|1.8||||||0.5 hr Post dose||1.8|-4.5|
73958387|NCT05046132|147452016|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-4.0|3.3||||||1 hr Post dose||3.3|-4.0|
73958388|NCT05046132|147452016|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.0|3.6||||||1.5 hr Post dose||3.6|-3.0|
73958389|NCT05046132|147452016|OTHER||LS Mean|-1.0|||||TWO_SIDED|90.0|-4.0|2.0||||||2 hr Post dose||2.0|-4.0|
73958390|NCT05046132|147452016|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-2.6|3.6||||||2.5 hr Post dose||3.6|-2.6|
73958391|NCT05046132|147452016|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-3.7|2.3||||||3 hr Post dose||2.3|-3.7|
73958392|NCT05046132|147452016|OTHER||LS Mean|-2.3|||||TWO_SIDED|90.0|-5.4|0.9||||||4 hr Post dose||0.9|-5.4|
73958393|NCT05046132|147452016|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-2.5|4.6||||||5 hr Post dose||4.6|-2.5|
73958394|NCT05046132|147452016|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-4.1|2.8||||||6 hr Post dose||2.8|-4.1|
73958395|NCT05046132|147452016|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-5.0|1.3||||||7 hr Post dose||1.3|-5.0|
73958396|NCT05046132|147452016|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-3.7|2.8||||||8 hr Post dose||2.8|-3.7|
73958397|NCT05046132|147452016|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.4|3.1||||||9 hr Post dose||3.1|-3.4|
73958398|NCT05046132|147452016|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-2.8|3.7||||||10 hr Post dose||3.7|-2.8|
73958399|NCT05046132|147452016|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.9|3.1||||||12 hr Post dose||3.1|-2.9|
73958400|NCT05046132|147452016|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-3.1|4.3||||||16 hr Post dose||4.3|-3.1|
73958401|NCT05046132|147452016|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-2.5|5.9||||||24 hr Post dose||5.9|-2.5|
73958402|NCT05046132|147452017|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-2.6|1.2||||||Pre dose||1.2|-2.6|
73958403|NCT05046132|147452017|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-2.6|0.7||||||0.5 hr post dose||0.7|-2.6|
73958404|NCT05046132|147452017|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.1|2.3||||||1 hr post dose||2.3|-1.1|
73958405|NCT05046132|147452017|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.5|1.3||||||1.5 hr post dose||1.3|-1.5|
73958406|NCT05046132|147452017|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.8|2.4||||||2 hr post dose||2.4|-0.8|
73958407|NCT05046132|147452017|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.0|2.4||||||2.5 hr post dose||2.4|-1.0|
73946728|NCT03682705|147425513|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|90.0|-2.03|-0.85|||t-test, 2 sided|||Mixed-Effect Model Repeated Measure (MMRM) analysis was conducted, testing the superiority of the combination of upadacitinib 15 mg and elsubrutinib 60 mg compared to placebo at Week 12. Data collected after a participant discontinued study drug was considered as missing. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline DAS28 (CRP) measurement.||-0.85|-2.03|<0.001
73946729|NCT01874145|147425596|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.501|STANDARD_ERROR_OF_MEAN|0.101||0.0006|TWO_SIDED|95.0|0.338|0.743||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group.|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.||0.743|0.338|0.0006
73946730|NCT01874145|147425598|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.101||0.0006|TWO_SIDED|95.0|0.337|0.742||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.||0.742|0.337|0.0006
73946731|NCT01874145|147425599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.058|STANDARD_ERROR_OF_MEAN|1.206||0.0897|TWO_SIDED|95.0|-4.438|0.322||The overall significance level for this study was 5% using 2-tailed test.|ANCOVA|In addition to treatment group, month (categorical), treatment-by-month interaction and score at baseline were used as covariates.|GA 40 mg/mL TIW treatment group vs. GA 20 mg/mL QD treatment group.|"To control for type 1 errors, secondary variables were analyzed only if analysis of the primary variable was statistically significant. Gate-keeping procedures offered further control with this hierarchy:~1. the rate of ISRs~2. change from baseline to month 4 (change - M4) in MSIS-20 physical wellbeing~3. change - M4 in MSIS-20 psychological wellbeing~4. change - M4 in TSQM-9 convenience~5. change - M4 in TSQM-9 overall satisfaction"||0.322|-4.438|0.0897
73946732|NCT00402337|147425619|SUPERIORITY_OR_OTHER|||||||0.0337||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||0.0337
73946733|NCT00402337|147425619|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||0.0010
73946734|NCT00402337|147425619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||<0.0001
73946735|NCT00402337|147425619|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||<0.0001
73946736|NCT02821819|147425677|NON_INFERIORITY|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|Mean Difference (Final Values)|18.0|STANDARD_DEVIATION|8.1||0.8|ONE_SIDED|||||a priori threshold for statistical significance: \<0.05|t-test, 1 sided|||The sample size was calculated assuming a non-inferiority margin of 5 eggs and a standard deviation (SD) of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|"Since the number of collected eggs constitutes the main outcome of the study, the sample size was calculated assuming a non-inferiority margin of 5 eggs with an standard deviation of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).~Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of \<.05 was considered significant."|||0.8
73946737|NCT02821819|147425677|NON_INFERIORITY|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.|Mean Difference (Final Values)|82.0||||0.8|TWO_SIDED|||||a priori threshold for statistical significance: \<0.05|Chi-squared|||The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.||||0.8
73946738|NCT02821819|147425678|NON_INFERIORITY|Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of \<.05 was considered significant.|Median Difference (Final Values)|71.1|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73946739|NCT00085202|147425688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8001||95.0|||||Log Rank|||||||0.8001
73946740|NCT00085202|147425688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5195||95.0|||||Log Rank|||||||0.5195
73946741|NCT00085202|147425688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7696||95.0|||||Log Rank|||||||0.7696
73946742|NCT00085202|147425689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206||95.0|||||Log Rank|||||||0.0206
74032016|NCT02389816|147617254|SUPERIORITY||LS mean difference|-3.07|STANDARD_ERROR_OF_MEAN|1.003||0.0023|TWO_SIDED|95.0|-5.05|-1.1|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||||-1.10|-5.05|0.0023
73946743|NCT00085202|147425691|SUPERIORITY|||||||0.6231|||||||t-test, 2 sided|||Change over time||||0.6231
73946744|NCT00085202|147425691|SUPERIORITY|||||||0.572|||||||t-test, 2 sided|||Baseline||||0.5720
74032017|NCT02389816|147617255|SUPERIORITY||Odds Ratio (OR)|1.621||||0.0341|TWO_SIDED|95.0|1.037|2.533|||Regression, Logistic|||||2.533|1.037|0.0341
73946745|NCT02081950|147425699|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|93.65|||||TWO_SIDED|90.0|87.56|100.16||||||||100.16|87.56|
73946746|NCT02081950|147425700|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|100.46|||||TWO_SIDED|90.0|95.74|105.42||||||||105.42|95.74|
73946747|NCT02081950|147425701|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|101.16|||||TWO_SIDED|90.0|96.32|106.24||||||||106.24|96.32|
73946748|NCT02081950|147425702|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|94.88|||||TWO_SIDED|90.0|88.49|101.73||||||||101.73|88.49|
73946749|NCT02081950|147425703|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|97.13|||||TWO_SIDED|90.0|89.93|104.91||||||||104.91|89.93|
73946750|NCT02081950|147425704|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|108.84|||||TWO_SIDED|90.0|95.61|123.91||||||||123.91|95.61|
73946751|NCT02081950|147425715|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|102.45|||||TWO_SIDED|90.0|96.31|109.0||||||||109.0|96.31|
73946752|NCT02081950|147425716|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|95.84|||||TWO_SIDED|90.0|79.11|116.11||||||||116.11|79.11|
73946753|NCT02081950|147425718|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|99.54|||||TWO_SIDED|90.0|95.69|103.54||||||||103.54|95.69|
73946754|NCT02081950|147425722|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|98.36|||||TWO_SIDED|90.0|95.31|101.51||||||||101.51|95.31|
73946755|NCT02081950|147425723|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject|geometric least square mean ratio|111.3|||||TWO_SIDED|90.0|99.73|124.2||||||||124.2|99.73|
73946756|NCT02081950|147425726|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject|geometric least square mean ratio|98.7|||||TWO_SIDED|90.0|93.16|104.57||||||||104.57|93.16|
73946757|NCT02081950|147425727|OTHER||geometric least square mean ratio|103.43|||||TWO_SIDED|90.0|94.5|113.2||||||||113.2|94.5|
73946758|NCT02081950|147425728|OTHER||geometric least square mean ratio|92.92|||||TWO_SIDED|90.0|80.58|107.16||||||||107.16|80.58|
73946759|NCT00110890|147425747|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.72|13.36|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||13.36|5.72|<0.001
74032018|NCT02389816|147617255|SUPERIORITY||Odds Ratio (OR)|1.788||||0.011||95.0|1.143|2.799|||Regression, Logistic|||||2.799|1.143|0.0110
73946760|NCT00110890|147425748|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.38|14.19|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||14.19|5.38|<0.001
73946761|NCT00110890|147425749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.11|||<|0.001||95.0|2.0|4.84|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||4.84|2.00|<0.001
73946762|NCT00110890|147425750|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.93|||<|0.001||95.0|4.65|10.34|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||10.34|4.65|<0.001
73946763|NCT00110890|147425751|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.002||95.0|1.26|2.81|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||2.81|1.26|0.002
73946764|NCT01975220|147425752|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.98|STANDARD_DEVIATION|5.4|<|0.0001|TWO_SIDED|90.0|97.275|102.751|||ANOVA||Adjusted geometric mean (GM) ratio(%) was calculated as GM of 'High dose, fasted:1 FDC tablet' divided by GM of 'High dose, fasted:3 single tablets'.The 'standard deviation' is actually intra-individual geometric coefficient of variation (gCV (%)).|||102.751|97.275|<0.0001
73946765|NCT01975220|147425752|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|97.09|STANDARD_DEVIATION|6.7|<|0.0001|TWO_SIDED|90.0|93.857|100.436|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||100.436|93.857|<0.0001
73946766|NCT01975220|147425752|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|100.7|STANDARD_DEVIATION|4.9|<|0.0001|TWO_SIDED|90.0|98.28|103.18|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.18|98.28|<0.0001
73946767|NCT01975220|147425753|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|94.65|STANDARD_DEVIATION|28.1||0.0256|TWO_SIDED|90.0|82.29|108.88|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||108.88|82.29|0.0256
73958408|NCT05046132|147452017|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.6|2.0||||||3 hr post dose||2.0|-1.6|
73958409|NCT05046132|147452017|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.9|2.3||||||4 hr post dose||2.3|-0.9|
74032019|NCT02389816|147617256|SUPERIORITY||Odds Ratio (OR)|1.839||||0.0186|TWO_SIDED|95.0|1.107|3.054|||Regression, Logistic|||||3.054|1.107|0.0186
74089261|NCT02697773|147731609|SUPERIORITY||Least Square Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0498|TWO_SIDED|95.0|-0.31|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.00|-0.31|0.0498
74089262|NCT02697773|147731609|SUPERIORITY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.238|TWO_SIDED|95.0|-0.24|0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||0.06|-0.24|0.2380
74089263|NCT02697773|147731609|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.09||0.0426|TWO_SIDED|95.0|-0.34|-0.01|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.01|-0.34|0.0426
74089264|NCT02697773|147731609|SUPERIORITY||Least Square Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.09||0.0014|TWO_SIDED|95.0|-0.45|-0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.11|-0.45|0.0014
73870077|NCT01278797|147284114|SUPERIORITY_OR_OTHER||Test/Reference ratio of geometric means|94.51||||0.005||90.0|91.6|97.51|||ANOVA|ANOVA was applied to log-transformed AUC72 and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.||97.51|91.60|0.005
73946768|NCT01975220|147425753|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.69|STANDARD_DEVIATION|7.1|<|0.0001|TWO_SIDED|90.0|96.25|103.26|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.26|96.25|<0.0001
73946769|NCT01975220|147425753|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.76|STANDARD_DEVIATION|24.2||0.002|TWO_SIDED|90.0|88.65|112.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||112.27|88.65|0.0020
73946770|NCT01975220|147425754|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|100.1|STANDARD_DEVIATION|5.1|<|0.0001|TWO_SIDED|90.0|97.555|102.719|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||102.719|97.555|<0.0001
73946771|NCT01975220|147425754|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|97.01|STANDARD_DEVIATION|7.0|<|0.0001|TWO_SIDED|90.0|93.622|100.531|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||100.531|93.622|<0.0001
73946772|NCT01975220|147425754|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|100.78|STANDARD_DEVIATION|4.9|<|0.0001|TWO_SIDED|90.0|98.36|103.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.27|98.36|<0.0001
73946773|NCT01975220|147425755|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|109.07|STANDARD_DEVIATION|17.4||0.0072|TWO_SIDED|90.0|99.892|119.1|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||119.100|99.892|0.0072
74089265|NCT02697773|147731611|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0027|TWO_SIDED|95.0|1.22|2.61|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.61|1.22|0.0027
74089266|NCT02697773|147731611|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0004|TWO_SIDED|95.0|1.36|2.89|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.89|1.36|0.0004
73946774|NCT01975220|147425755|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|92.42|STANDARD_DEVIATION|12.5||0.0004|TWO_SIDED|90.0|86.781|98.428|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||98.428|86.781|0.0004
73870078|NCT01278797|147284115|SUPERIORITY_OR_OTHER||Test/Reference ratio of geometric means|94.1||||0.0093||90.0|90.7|97.63|||ANOVA|ANOVA was applied to log-transformed CMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.||97.63|90.70|0.0093
73870079|NCT01278797|147284116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.153|||||||ANOVA|ANOVA was applied to TMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg||||0.153
73870080|NCT04254666|147284121|OTHER||||||||||||||||||pre and post scores for this measure are presented as the percent of foods correctly classified.|||
73870081|NCT01865448|147284156|SUPERIORITY_OR_OTHER|||||||0.278|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2780
73870082|NCT01865448|147284156|SUPERIORITY_OR_OTHER|||||||0.8689|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.8689
73946775|NCT01975220|147425755|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|105.37|STANDARD_DEVIATION|17.7||0.0014|TWO_SIDED|90.0|96.6|114.942|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||114.942|96.600|0.0014
73946776|NCT01975220|147425756|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|96.65|STANDARD_DEVIATION|29.8||0.0198|TWO_SIDED|90.0|83.337|112.079|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||112.079|83.337|0.0198
73946777|NCT01975220|147425756|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|110.17|STANDARD_DEVIATION|12.0||0.0007|TWO_SIDED|90.0|103.809|116.926|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||116.926|103.809|0.0007
73946778|NCT01975220|147425756|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|97.68|STANDARD_DEVIATION|23.8||0.0037|TWO_SIDED|90.0|86.942|109.734|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||109.734|86.942|0.0037
73946779|NCT01975220|147425757|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|95.4|STANDARD_DEVIATION|29.4||0.0254|TWO_SIDED|90.0|82.42|110.44|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||110.44|82.42|0.0254
73870083|NCT01865448|147284156|SUPERIORITY_OR_OTHER|||||||0.4533|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.4533
73870084|NCT01865448|147284157|SUPERIORITY_OR_OTHER|||||||0.71833|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.71833
73870085|NCT01865448|147284157|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
73870086|NCT01865448|147284157|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Within-group comparisons between the baseline and 6 month data||||<0.001
73870087|NCT01865448|147284158|SUPERIORITY_OR_OTHER|||||||0.519|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.51900
73870088|NCT01865448|147284158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
73870089|NCT01865448|147284158|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
73870090|NCT01865448|147284159|SUPERIORITY_OR_OTHER|||||||0.24567|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.24567
73870091|NCT01865448|147284159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
73870092|NCT01865448|147284159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
73870093|NCT01865448|147284160|SUPERIORITY_OR_OTHER|||||||0.9573|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9573
73870094|NCT01865448|147284160|SUPERIORITY_OR_OTHER|||||||0.5257|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5257
73870095|NCT01865448|147284160|SUPERIORITY_OR_OTHER|||||||0.0657|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0657
73870096|NCT01865448|147284161|SUPERIORITY_OR_OTHER|||||||0.7474|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7474
73870097|NCT01865448|147284161|SUPERIORITY_OR_OTHER|||||||0.3745|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3745
73870098|NCT01865448|147284161|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0476
73870099|NCT01865448|147284162|SUPERIORITY_OR_OTHER|||||||0.27444|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.27444
73870100|NCT01865448|147284162|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
73870101|NCT01865448|147284162|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
73870102|NCT01865448|147284163|SUPERIORITY_OR_OTHER|||||||0.28489|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.28489
73870103|NCT01865448|147284163|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
73870104|NCT01865448|147284163|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
73870105|NCT01865448|147284164|SUPERIORITY_OR_OTHER|||||||0.04491|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.04491
73870106|NCT01865448|147284164|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
73958410|NCT05046132|147452017|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-1.2|2.1||||||5 hr post dose||2.1|-1.2|
73946780|NCT01975220|147425757|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|99.63|STANDARD_DEVIATION|7.1|<|0.0001|TWO_SIDED|90.0|96.21|103.17|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.17|96.21|<0.0001
73946781|NCT01975220|147425757|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|101.06|STANDARD_DEVIATION|24.4||0.0029|TWO_SIDED|90.0|89.7|113.86|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||113.86|89.70|0.0029
73946782|NCT01960530|147425818|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|60.12|||||TWO_SIDED|90.0|54.69|66.1||||||Evaluation of Cmax||66.10|54.69|
73946783|NCT01960530|147425818|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|106.83|||||TWO_SIDED|90.0|96.92|117.76||||||||117.76|96.92|
73946784|NCT01960530|147425823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|86.99|||||TWO_SIDED|90.0|79.23|95.52||||||||95.52|79.23|
73946785|NCT01960530|147425823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|89.96|||||TWO_SIDED|90.0|81.72|99.04||||||||99.04|81.72|
73946786|NCT01301274|147425824|NON_INFERIORITY_OR_EQUIVALENCE|beta error 20%, alfa error 5%, diminished 2 mEq/L between groups||||||0.04||95.0|||||t-test, 2 sided|||||||0.04
73946787|NCT01301274|147425825|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||without adjust|Chi-squared|||||||0.081
73946788|NCT01301274|147425826|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||t-test, 2 sided|||||||0.396
73976318|NCT01787032|147498184|SUPERIORITY_OR_OTHER||Ratio|373.66|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|346.029|403.507|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||403.507|346.029|
73976319|NCT01787032|147498184|SUPERIORITY_OR_OTHER||Ratio|266.94|STANDARD_DEVIATION|16.0|||TWO_SIDED|90.0|243.267|292.914|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||292.914|243.267|
74032020|NCT02389816|147617256|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0418|TWO_SIDED|95.0|1.02|2.834|||Regression, Logistic|||||2.834|1.020|0.0418
74032021|NCT02389816|147617257|SUPERIORITY||LS mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.753||0.0165|TWO_SIDED|95.0|-3.29|-0.332|||ANCOVA|||||-0.332|-3.290|0.0165
73946789|NCT01301274|147425827|SUPERIORITY_OR_OTHER|||||||0.129||95.0|||||t-test, 2 sided|||||||0.129
74009067|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS mean Difference|1.11|STANDARD_ERROR_OF_MEAN|1.021||0.286|TWO_SIDED|80.0|-0.23|2.45|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.45|-0.23|0.286
73946790|NCT04064242|147425851|OTHER|A Bayesian model for repeated measurements including data collected at Weeks 4, 8, 12 and 16 was applied to compare FVC between CMK389 and placebo groups.|Posterior estimate treatment difference|-1.49|STANDARD_DEVIATION|1.62||0.1804|TWO_SIDED|80.0|-3.56|0.6|||Bayesian analysis|Posterior probability that treatment is better than placebo.|80% credible intervals are reported on the treatment difference|||0.60|-3.56|0.1804
73946791|NCT04064242|147425857|SUPERIORITY||Median Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.783|TWO_SIDED|80.0|-0.09|0.02|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||0.02|-0.09|0.783
73946792|NCT04064242|147425858|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.664||0.608|TWO_SIDED|80.0|-1.05|0.68|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||0.68|-1.05|0.608
73946793|NCT04064242|147425859|SUPERIORITY||Median Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|13.126||0.479|TWO_SIDED|80.0|-16.35|17.76|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||17.76|-16.35|0.479
73946794|NCT04512066|147425860|OTHER||treatment effect|0.6||||0.849|TWO_SIDED|90.0|-4.58|5.78|||Mixed Models Analysis|||||5.78|-4.58|0.849
73946795|NCT04512066|147425860|OTHER||treatment effect|-2.83||||0.362|TWO_SIDED|90.0|-7.96|2.29|||Mixed Models Analysis|||||2.29|-7.96|0.362
73946796|NCT04512066|147425860|OTHER||treatment effect|-10.45||||0.001|TWO_SIDED|90.0|-15.46|-5.43|||Mixed Models Analysis|||||-5.43|-15.46|0.001
73946797|NCT00445679|147425873|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-3.13|||||TWO_SIDED|95.0|-12.62|6.37||||||||6.37|-12.62|
74009068|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|1.172||0.362|TWO_SIDED|80.0|-0.45|2.63|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.63|-0.45|0.362
74009069|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|1.48|STANDARD_ERROR_OF_MEAN|1.069||0.179|TWO_SIDED|80.0|0.07|2.88|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.88|0.07|0.179
74009070|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06|STANDARD_ERROR_OF_MEAN|1.092||0.342|TWO_SIDED|80.0|-0.38|2.49|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.49|-0.38|0.342
73870107|NCT01865448|147284164|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
73870108|NCT01865448|147284165|SUPERIORITY_OR_OTHER|||||||0.24396|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.24396
73870109|NCT01865448|147284165|SUPERIORITY_OR_OTHER|||||||0.00162|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.00162
73870110|NCT01865448|147284165|SUPERIORITY_OR_OTHER|||||||0.00162|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.00162
73946798|NCT00445679|147425873|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|0.88|||||TWO_SIDED|95.0|-8.5|10.25||||||||10.25|-8.50|
73946799|NCT00445679|147425873|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-2.17|||||TWO_SIDED|95.0|-11.68|7.33||||||||7.33|-11.68|
73946800|NCT00445679|147425874|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.714
73946801|NCT00445679|147425874|SUPERIORITY_OR_OTHER|||||||0.653||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.653
73946802|NCT00445679|147425874|SUPERIORITY_OR_OTHER|||||||0.881||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.881
73946803|NCT00445679|147425875|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.450
73946804|NCT00445679|147425875|SUPERIORITY_OR_OTHER|||||||0.452||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.452
73870111|NCT01865448|147284166|SUPERIORITY_OR_OTHER|||||||0.82322|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.82322
73870112|NCT01865448|147284166|SUPERIORITY_OR_OTHER|||||||0.25908|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.25908
73870113|NCT01865448|147284166|SUPERIORITY_OR_OTHER|||||||0.25908|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.25908
73870114|NCT01865448|147284167|SUPERIORITY_OR_OTHER|||||||0.76435|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.76435
73870115|NCT01865448|147284167|SUPERIORITY_OR_OTHER|||||||0.18876|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.18876
73870116|NCT01865448|147284167|SUPERIORITY_OR_OTHER|||||||0.18876|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.18876
73870117|NCT01865448|147284168|SUPERIORITY_OR_OTHER|||||||0.40485|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.40485
73870118|NCT01865448|147284168|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
73870119|NCT01865448|147284168|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
73870120|NCT01865448|147284169|SUPERIORITY_OR_OTHER|||||||0.13911|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.13911
73870121|NCT01865448|147284169|SUPERIORITY_OR_OTHER|||||||0.05726|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.05726
73870122|NCT01865448|147284169|SUPERIORITY_OR_OTHER|||||||0.05726|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.05726
73870123|NCT01865448|147284170|SUPERIORITY_OR_OTHER|||||||0.60214|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.60214
73870124|NCT01865448|147284170|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
73870125|NCT01865448|147284170|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
73870126|NCT01865448|147284171|SUPERIORITY_OR_OTHER|||||||0.66053|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.66053
73870127|NCT01865448|147284171|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
73870128|NCT01865448|147284171|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.05
73870129|NCT01865448|147284172|SUPERIORITY_OR_OTHER|||||||0.28743|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.28743
73870130|NCT01865448|147284172|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
73870131|NCT01865448|147284172|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
73870132|NCT01865448|147284173|SUPERIORITY_OR_OTHER|||||||0.58561|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.58561
73946805|NCT00445679|147425875|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.850
73946806|NCT03857230|147425888|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline AUC0-192 were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|93.31||||0.05|TWO_SIDED|90.0|87.25|99.79|||ANOVA|||Statistical comparison of the obtained results comprised the calculation of parametric bilateral 90 % CIs for the ratios of the corresponding mean values of the pharmacokinetic parameters of the study and comparator drug. The equivalence of the pharmacokinetics of the drug products will be proven if the limits of the evaluated CIs for the ratios of the mean values are in the range of 80.00-125.00%.||99.79|87.25|0.05
73946807|NCT03857230|147425889|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline Cmax were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|87.93||||0.05|TWO_SIDED|90.0|82.85|93.33|||ANOVA|||||93.33|82.85|0.05
73946808|NCT03535337|147425900|SUPERIORITY||Slope|2.44|STANDARD_ERROR_OF_MEAN|1.1||0.03|TWO_SIDED|95.0|0.28|4.59|||Mixed Models Analysis|||||4.59|0.28|0.03
73946809|NCT03535337|147425901|SUPERIORITY||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.76||0.82|TWO_SIDED|95.0|-1.32|1.66|||Mixed Models Analysis|||||1.66|-1.32|0.82
73958411|NCT05046132|147452017|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.7|2.4||||||6 hr post dose||2.4|-0.7|
73958412|NCT05046132|147452017|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.6|2.4||||||7 hr post dose||2.4|-0.6|
73958413|NCT05046132|147452017|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.0|2.2||||||8 hr post dose||2.2|-1.0|
73946810|NCT00939731|147425916|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|92.61|||||TWO_SIDED|90.0|84.84|101.09||||||Natural log transformed AUClast of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||101.09|84.84|
73946811|NCT00939731|147425919|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|92.43|||||TWO_SIDED|90.0|84.86|100.68||||||Natural log transformed AUC (0-∞) of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||100.68|84.86|
73946812|NCT00939731|147425920|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|98.91|||||TWO_SIDED|90.0|90.18|108.48||||||Natural log transformed Cmax of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CI for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.48|90.18|
73946813|NCT01213043|147425924|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin was: \[0.80, 1.25\]|Geometric Least Square Means Ratio|0.85|||<|0.0001|TWO_SIDED|90.0|0.83|0.88|||ANOVA|||Dose proportionality was analysed using an ANOVA model for the natural log-transformed AUC0-7days with treatment, period, and sequence as fixed effects and subject within sequence as a random effect. The treatment dose of 60 mg/kg was the reference treatment and 120 mg/kg was the test treatment. PK parameters in individual subjects for each treatment dose were dose normalized to 60mg/kg based on the actual dose administered at Week 8 or Week 18 (i.e., (AUC0-7days/Actual Dose in mg/kg)\*60mg/kg).||0.88|0.83|<0.0001
73946814|NCT01350141|147425964|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-21.81|STANDARD_ERROR_OF_MEAN|8.385||0.0137|TWO_SIDED|95.0|-38.85|-4.77|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.||-4.77|-38.85|0.0137
73946815|NCT01350141|147425964|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.42|STANDARD_ERROR_OF_MEAN|8.463|<|0.0001|TWO_SIDED|95.0|-63.62|-29.22|||ANCOVA|||Analysis was performed using ANCOVA model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.||-29.22|-63.62|<0.0001
73946816|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.825||||0.19|TWO_SIDED|95.0|0.36|169.74|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||169.74|0.36|0.1900
73946817|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|72.518||||0.0057|TWO_SIDED|95.0|3.48|1512.1|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||1512.10|3.48|0.0057
73946818|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.75||||0.0013|TWO_SIDED|95.0|3.49|175.63|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||175.63|3.49|0.0013
73946819|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.326||||0.0006|TWO_SIDED|95.0|5.26|426.01|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||426.01|5.26|0.0006
73946820|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.635||||0.6611|TWO_SIDED|95.0|0.18|14.73|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||14.73|0.18|0.6611
73946821|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.486||||0.0104|TWO_SIDED|95.0|1.84|98.61|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||98.61|1.84|0.0104
73946822|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.43||||0.0282|TWO_SIDED|95.0|1.22|33.89|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||33.89|1.22|0.0282
73946823|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.257||||0.0042|TWO_SIDED|95.0|2.36|98.42|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||98.42|2.36|0.0042
73946824|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.967||||0.5164|TWO_SIDED|95.0|0.11|79.24|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||79.24|0.11|0.5164
74032022|NCT02389816|147617257|SUPERIORITY||LS mean difference|-1.79|STANDARD_ERROR_OF_MEAN|0.759||0.019|TWO_SIDED|95.0|-3.278|-0.295|||ANCOVA|||||-0.295|-3.278|0.0190
73946825|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.36||||0.0445|TWO_SIDED|95.0|1.08|422.94|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||422.94|1.08|0.0445
73946826|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.157||||0.0223|TWO_SIDED|95.0|1.35|49.37|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||49.37|1.35|0.0223
73946827|NCT01350141|147425965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.587||||0.007|TWO_SIDED|95.0|2.04|90.4|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||90.40|2.04|0.0070
73946828|NCT01350141|147425966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.647||||0.2928|TWO_SIDED|95.0|0.22|142.04|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||142.04|0.22|0.2928
73958414|NCT05046132|147452017|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.6|1.3||||||9 hr post dose||1.3|-1.6|
74032023|NCT02389816|147617258|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.0031|TWO_SIDED|95.0|-0.59|-0.121|||ANCOVA|||||-0.121|-0.590|0.0031
74032024|NCT02389816|147617258|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.629|-0.158|||ANCOVA|||||-0.158|-0.629|0.0011
74032025|NCT02389816|147617259|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.123||0.0609|TWO_SIDED|95.0|-0.474|0.011|||ANCOVA|||||0.011|-0.474|0.0609
74032026|NCT02389816|147617259|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.124||0.0179|TWO_SIDED|95.0|-0.537|-0.051|||ANCOVA|||||-0.051|-0.537|0.0179
73946829|NCT01350141|147425966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|591.174||||0.0014|TWO_SIDED|95.0|11.68|29922.99|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||29922.99|11.68|0.0014
73946830|NCT01350141|147425966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.468||||0.2339|TWO_SIDED|95.0|0.45|26.88|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||26.88|0.45|0.2339
73976320|NCT01787032|147498185|SUPERIORITY_OR_OTHER||Ratio|261.34|STANDARD_DEVIATION|37.3|||TWO_SIDED|90.0|211.692|322.633|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||322.633|211.692|
73976321|NCT01787032|147498185|SUPERIORITY_OR_OTHER||Ratio|213.39|STANDARD_DEVIATION|34.1|||TWO_SIDED|90.0|175.783|259.051|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||259.051|175.783|
73976322|NCT01787032|147498186|SUPERIORITY_OR_OTHER||Ratio|372.88|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|345.456|402.477|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||402.477|345.456|
74032027|NCT02389816|147617260|SUPERIORITY||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.621||0.0311|TWO_SIDED|95.0|-2.564|-0.122|||ANCOVA|||||-0.122|-2.564|0.0311
74032028|NCT02389816|147617260|SUPERIORITY||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.628||0.0126|TWO_SIDED|95.0|-2.807|-0.339|||ANCOVA|||||-0.339|-2.807|0.0126
74032029|NCT02389816|147617261|SUPERIORITY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.893||0.3793|TWO_SIDED|95.0|-2.539|0.968|||ANCOVA|||||0.968|-2.539|0.3793
73946831|NCT01350141|147425966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|23.442||||0.0025|TWO_SIDED|95.0|3.03|181.11|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||181.11|3.03|0.0025
73946832|NCT01350141|147425966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.502||||0.1786|TWO_SIDED|95.0|0.38|192.32|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||192.32|0.38|0.1786
73976323|NCT01787032|147498186|SUPERIORITY_OR_OTHER||Ratio|266.56|STANDARD_DEVIATION|16.0|||TWO_SIDED|90.0|242.955|292.456|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||292.456|242.955|
73976324|NCT02195232|147498220|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
74032030|NCT02389816|147617261|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.891||0.9011|TWO_SIDED|95.0|-1.862|1.641|||ANCOVA|||||1.641|-1.862|0.9011
74032031|NCT02389816|147617262|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.329||0.0089|TWO_SIDED|95.0|-1.512|-0.218|||ANCOVA|||||-0.218|-1.512|0.0089
74032032|NCT02389816|147617262|SUPERIORITY||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|0.332||0.0001|TWO_SIDED|95.0|-1.922|-0.619|||ANCOVA|||||-0.619|-1.922|0.0001
74032033|NCT03161678|147617280|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.|||||<|0.001|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 G143E mutation. The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||<0.001
73870133|NCT01865448|147284173|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
73946833|NCT01350141|147425966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|51.185||||0.0121|TWO_SIDED|95.0|2.37|1107.57|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||1107.57|2.37|0.0121
73946834|NCT01588990|147425977|SUPERIORITY_OR_OTHER|||||||0.101|||||||Cox Proportional Hazards Model|||||||0.101
73946835|NCT01588990|147425989|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cox Proportional Hazards Model|||||||0.052
73946836|NCT01588990|147425990|SUPERIORITY_OR_OTHER|||||||0.797|||||||Cox Proportional Hazards Model|||||||0.797
74039476|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-2.7|-1.21|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-1.21|-2.70|<.0001
73946837|NCT01588990|147425991|SUPERIORITY_OR_OTHER|||||||0.188|||||||Cox Proportional Hazards Model|||||||0.188
73946838|NCT01588990|147425992|SUPERIORITY_OR_OTHER|||||||0.016|||||||Cox Proportional Hazards Model|||||||0.016
73976325|NCT01759862|147498223|SUPERIORITY|Our calculations showed that by enrolling 50 patients we will be able to detect a 25cc/min absolute difference in eGFR between the two arms with power above 80%, and a two-sided Type I probability error of \<0.05.||||||0.32|||||||t-test, 2 sided|||Intention to treat analysis||||0.32
73946839|NCT02367716|147426002|OTHER|The mean change in QRS duration between Baseline and 6 months|Mean Difference (Final Values)|-13.9|STANDARD_DEVIATION|29.6|||TWO_SIDED|||||||||||||
73946840|NCT03592277|147426039|SUPERIORITY|||||||0.344|||||||Chi-squared|||||||0.344
73946841|NCT03592277|147426040|SUPERIORITY|||||||0.526|||||||Chi-squared|||||||0.526
73946842|NCT03592277|147426041|SUPERIORITY|||||||0.123|||||||Chi-squared|||||||0.123
73946843|NCT03592277|147426042|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.660
73946844|NCT03592277|147426043|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||0.745
73946845|NCT03592277|147426044|SUPERIORITY|||||||0.236|||||||Chi-squared|||||||0.236
73946846|NCT01462162|147426045|SUPERIORITY_OR_OTHER|||||||0.006|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score||||0.006
73946847|NCT01462162|147426045|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score||||0.000
73946848|NCT01462162|147426045|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score||||0.000
73946849|NCT01462162|147426046|SUPERIORITY_OR_OTHER|||||||0.023|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score||||0.023
73946850|NCT01462162|147426046|SUPERIORITY_OR_OTHER|||||||0.007|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score||||0.007
73870134|NCT01865448|147284173|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
73946851|NCT01462162|147426046|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score||||0.000
73946852|NCT01462162|147426047|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 12||||<0.001
73946853|NCT01462162|147426047|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 24||||<0.001
73946854|NCT01462162|147426048|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
73946855|NCT01462162|147426048|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
73946856|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in DAS-28 at Week 12||||0.003
73946857|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.006|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in DAS-28 at Week 24||||0.006
73946858|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.791|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in serum hemoglobin Week 12||||0.791
73946859|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.847|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in serum hemoglobin Week 24||||0.847
73946860|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.182|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in swollen joint count Week 12||||0.182
73946861|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.022|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in swollen joint count Week 24||||0.022
73946862|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.163|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in morning stiffness Week 12||||0.163
73946863|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.115|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in morning stiffness Week 24||||0.115
73946864|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.037|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in degree of pain Week 12||||0.037
73946865|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.044|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in degree of pain Week 24||||0.044
73946866|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in sleepiness at Week 12||||0.003
73946867|NCT01462162|147426049|SUPERIORITY_OR_OTHER|||||||0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in sleepiness at Week 24||||0.001
73946868|NCT01462162|147426049|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in depression Week 12||||<0.001
73946869|NCT01462162|147426049|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in depression at Week 24||||<0.001
73946870|NCT01462162|147426050|SUPERIORITY_OR_OTHER|||||||0.678|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 12)||||0.678
73946871|NCT01462162|147426050|SUPERIORITY_OR_OTHER|||||||0.348|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 24)||||0.348
73946872|NCT01462162|147426050|SUPERIORITY_OR_OTHER|||||||0.679|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)||||0.679
73946873|NCT01462162|147426050|SUPERIORITY_OR_OTHER|||||||0.556|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)||||0.556
73946874|NCT01462162|147426050|SUPERIORITY_OR_OTHER|||||||0.692|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 12)||||0.692
73946875|NCT01462162|147426050|SUPERIORITY_OR_OTHER|||||||0.771|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 24)||||0.771
73946876|NCT01462162|147426050|SUPERIORITY_OR_OTHER|||||||0.878|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 12)||||0.878
73946877|NCT01462162|147426050|SUPERIORITY_OR_OTHER|||||||0.139|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 24)||||0.139
73946878|NCT01462162|147426050|SUPERIORITY_OR_OTHER|||||||0.249|||||||Regression, Linear|||change in haemoglobin levels versus change in depression score (Week 12)||||0.249
73946879|NCT01462162|147426050|SUPERIORITY_OR_OTHER|||||||0.61|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)||||0.610
73946880|NCT01462162|147426051|SUPERIORITY_OR_OTHER|||||||0.257|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 12)||||0.257
73946881|NCT01462162|147426051|SUPERIORITY_OR_OTHER|||||||0.487|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 24)||||0.487
73946882|NCT01462162|147426051|SUPERIORITY_OR_OTHER|||||||0.644|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)||||0.644
73946883|NCT01462162|147426051|SUPERIORITY_OR_OTHER|||||||0.498|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)||||0.498
73946884|NCT01462162|147426051|SUPERIORITY_OR_OTHER|||||||0.65|||||||Regression, Linear|||change in hemoglobin levels versus change in degree of pain (Week 12)||||0.650
73946885|NCT01462162|147426051|SUPERIORITY_OR_OTHER|||||||0.75|||||||Regression, Cox|||change in hemoglobin levels versus change in degree of pain (Week 24)||||0.750
73946886|NCT01462162|147426051|SUPERIORITY_OR_OTHER|||||||0.936|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 12)||||0.936
73946887|NCT01462162|147426051|SUPERIORITY_OR_OTHER|||||||0.075|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 24)||||0.075
73946888|NCT01462162|147426051|SUPERIORITY_OR_OTHER|||||||0.098|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 12)||||0.098
73946889|NCT01462162|147426051|SUPERIORITY_OR_OTHER|||||||0.09|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)||||0.090
73946890|NCT01462162|147426052|SUPERIORITY_OR_OTHER|||||||0.077|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 12)||||0.077
73946891|NCT01462162|147426052|SUPERIORITY_OR_OTHER|||||||0.961|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 24)||||0.961
73946892|NCT01462162|147426053|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
73946893|NCT01462162|147426053|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
73946894|NCT01462162|147426054|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
73946895|NCT01462162|147426054|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
73946896|NCT01462162|147426055|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
73946897|NCT01462162|147426055|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
73946898|NCT01462162|147426056|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
73946899|NCT01462162|147426056|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
73946900|NCT01462162|147426057|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
73946901|NCT01462162|147426057|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
73946902|NCT01462162|147426058|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
73946903|NCT01462162|147426058|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
73946904|NCT01462162|147426059|SUPERIORITY_OR_OTHER|||||||0.172|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||0.172
73946905|NCT01462162|147426059|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Logistic|||Baseline for Week 24 versus Week 24||||<0.05
73946906|NCT01462162|147426060|SUPERIORITY_OR_OTHER|||||||0.162|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||0.162
73958415|NCT05046132|147452017|OTHER||LS Mean|0.0|||||TWO_SIDED|90.0|-1.5|1.6||||||10 hr post dose||1.6|-1.5|
73958416|NCT05046132|147452017|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-0.2|3.0||||||12 hr post dose||3.0|-0.2|
73958417|NCT05046132|147452017|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.3|3.4||||||16 hr post dose||3.4|-0.3|
73958418|NCT05046132|147452017|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-2.1|1.6||||||24 hr post dose||1.6|-2.1|
73958419|NCT05046132|147452017|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.2|2.6||||||Pre dose||2.6|-1.2|
73958420|NCT05046132|147452017|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-1.9|1.4||||||0.5 hr post dose||1.4|-1.9|
73958421|NCT05046132|147452017|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-1.2|2.2||||||1 hr post dose||2.2|-1.2|
73958422|NCT05046132|147452017|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.7|2.1||||||1.5 hr post dose||2.1|-0.7|
73958423|NCT05046132|147452017|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.1|2.2||||||2 hr post dose||2.2|-1.1|
73958424|NCT05046132|147452017|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.9|2.5||||||2.5 hr post dose||2.5|-0.9|
73958425|NCT05046132|147452017|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.5|2.1||||||3 hr post dose||2.1|-1.5|
73958426|NCT05046132|147452017|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-2.1|1.1||||||4 hr post dose||1.1|-2.1|
73958427|NCT05046132|147452017|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.5|1.9||||||5 hr post dose||1.9|-1.5|
73958428|NCT05046132|147452017|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.7|1.4||||||6 hr post dose||1.4|-1.7|
73958429|NCT05046132|147452017|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.6|1.4||||||7 hr post dose||1.4|-1.6|
73958430|NCT05046132|147452017|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.7|2.4||||||8 hr post dose||2.4|-0.7|
73958431|NCT05046132|147452017|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.6|1.3||||||9 hr post dose||1.3|-1.6|
73958432|NCT05046132|147452017|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-1.4|1.6||||||10 hr post dose||1.6|-1.4|
73958433|NCT05046132|147452017|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.1|3.1||||||12 hr post dose||3.1|-0.1|
73958434|NCT05046132|147452017|OTHER||LS Mean|1.2|||||TWO_SIDED|90.0|-0.7|3.0||||||16 hr post dose||3.0|-0.7|
73958435|NCT05046132|147452017|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.3|3.4||||||24 hr post dose||3.4|-0.3|
73870135|NCT01865448|147284174|SUPERIORITY_OR_OTHER|||||||0.1953|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1953
73870136|NCT01865448|147284174|SUPERIORITY_OR_OTHER|||||||0.0351|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0351
73946907|NCT01462162|147426060|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 24||||<0.001
73946908|NCT01462162|147426061|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
73946909|NCT01462162|147426061|SUPERIORITY_OR_OTHER||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.005
73946910|NCT01462162|147426062|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
73946911|NCT01462162|147426062|SUPERIORITY_OR_OTHER||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.005
73946912|NCT01462162|147426063|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
73946913|NCT01462162|147426063|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
73946914|NCT00909480|147426074|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: 0.4%.|Mean Difference (Net)|0.3003||||||95.0|0.1427|0.458|||ANCOVA|Full analysis set, Model adjusted for: HbA1c at baseline, previous oral anti-diabetic treatment and country.||||0.4580|0.1427|
73946915|NCT00861601|147426089|SUPERIORITY_OR_OTHER|||||||0.0104||95.0||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0104
73946916|NCT00861601|147426089|SUPERIORITY_OR_OTHER|||||||0.0057||95.0||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0057
73870137|NCT01865448|147284174|SUPERIORITY_OR_OTHER|||||||0.0795|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0795
73870138|NCT01865448|147284175|SUPERIORITY_OR_OTHER|||||||0.6664|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6664
73870139|NCT01865448|147284175|SUPERIORITY_OR_OTHER|||||||0.431|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.4310
73870140|NCT01865448|147284175|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0049
73870141|NCT01865448|147284176|SUPERIORITY_OR_OTHER|||||||0.247|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2470
73870142|NCT01865448|147284176|SUPERIORITY_OR_OTHER|||||||0.2755|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2755
73870143|NCT01865448|147284176|SUPERIORITY_OR_OTHER|||||||0.8226|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.8226
73870144|NCT01865448|147284177|SUPERIORITY_OR_OTHER|||||||0.6779|||||||ANCOVA|||Between-Group Comparison||||0.6779
73870145|NCT01865448|147284177|SUPERIORITY_OR_OTHER|||||||0.3761|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3761
73870146|NCT01865448|147284177|SUPERIORITY_OR_OTHER|||||||0.0281|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0281
73870147|NCT01865448|147284178|SUPERIORITY_OR_OTHER|||||||0.8591|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8591
73946917|NCT00861601|147426089|SUPERIORITY_OR_OTHER|||||||0.0808||95.0||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0808
73946918|NCT00861601|147426090|SUPERIORITY_OR_OTHER|||||||0.0116||95.0||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0116
73946919|NCT00861601|147426090|SUPERIORITY_OR_OTHER|||||||0.0066||95.0||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0066
73946920|NCT00861601|147426090|SUPERIORITY_OR_OTHER|||||||0.0846||95.0||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0846
73946921|NCT00098254|147426177|SUPERIORITY_OR_OTHER|||||||0.0027||95.0|||||Kaplan-Meier|||||||0.0027
73946922|NCT00098254|147426179|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Kaplan-Meier|||||||0.33
73946923|NCT00098254|147426180|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||Kaplan-Meier|||||||0.042
73946924|NCT00098254|147426181|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Kaplan-Meier|||||||0.028
73946925|NCT02118337|147426192|SUPERIORITY||Rate difference|-23.8||||0.5494|TWO_SIDED|95.0|-72.8|31.1|||Fisher Exact|||||31.1|-72.8|0.5494
73946926|NCT02118337|147426192|SUPERIORITY||Rate difference|-7.1||||0.513|TWO_SIDED|95.0|-33.6|20.0|||Fisher Exact|||||20.0|-33.6|0.5130
73946927|NCT01395823|147426293|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
73946928|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-75.0||||0.4788|TWO_SIDED|95.0|-284.8|134.9|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 1||134.9|-284.8|0.4788
73946929|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|124.1||||0.2309|TWO_SIDED|95.0|-80.6|328.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 1||328.9|-80.6|0.2309
73946930|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-185.1||||0.0758|TWO_SIDED|95.0|-389.8|19.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 1||19.7|-389.8|0.0758
73946931|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Median Difference (Net)|130.4||||0.2084|TWO_SIDED|95.0|-74.4|335.1|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 1||335.1|-74.4|0.2084
73958436|NCT05046132|147452018|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-1.3|2.9||||||Pre dose||2.9|-1.3|
73958437|NCT05046132|147452018|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-1.8|1.2||||||0.5 hr post dose||1.2|-1.8|
73958438|NCT05046132|147452018|OTHER||LS Mean|1.2|||||TWO_SIDED|90.0|-1.4|3.8||||||1 hr post dose||3.8|-1.4|
73958439|NCT05046132|147452018|OTHER||LS Mean|0.0|||||TWO_SIDED|90.0|-1.8|1.8||||||1.5 hr post dose||1.8|-1.8|
73958440|NCT05046132|147452018|OTHER||LS Mean|-1.4|||||TWO_SIDED|90.0|-3.0|0.3||||||2 hr post dose||0.3|-3.0|
73958441|NCT05046132|147452018|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|0.0|3.1||||||2.5 hr post dose||3.1|-0.0|
73958442|NCT05046132|147452018|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.7|1.5||||||3 hr post dose||1.5|-1.7|
74032034|NCT03161678|147617280|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.24|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 functional mutation (rs7498748). The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.24
74032035|NCT03161678|147617281|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.75|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 G143E mutation. The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.75
74032036|NCT03161678|147617281|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.011|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 functional mutation (rs7498748). The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.011
74032037|NCT01757704|147617284|SUPERIORITY_OR_OTHER||Median Difference (Net)|56.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
74032038|NCT02749721|147617305|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
74032039|NCT02749721|147617306|OTHER|||||||0.012|||||||Paired t-test|||||||0.012
74032040|NCT02749721|147617307|OTHER||Pearson's R|0.125||||0.61|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (amplitude) baseline scores||||0.610
74032041|NCT02749721|147617307|OTHER||Pearson's R|-0.294||||0.288|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (amplitude) baseline scores||||0.288
74032042|NCT02749721|147617307|OTHER||Pearson's R|-0.405||||0.134|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (amplitude) baseline scores||||0.134
74032043|NCT02749721|147617307|OTHER||Pearson's R|-0.397||||0.083|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (amplitude) baseline scores||||0.083
74032044|NCT02749721|147617307|OTHER||Pearson's R|-0.476||||0.034|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (amplitude) baseline scores||||0.034
74032045|NCT02749721|147617307|OTHER||Pearson's R|-0.509||||0.031|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 baseline scores||||0.031
74032046|NCT02749721|147617307|OTHER||Pearson's R|-0.197||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3a (amplitude) baseline scores||||0.500
74032047|NCT02749721|147617307|OTHER||Pearson's R|0.376||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b baseline scores||||0.185
74032048|NCT02749721|147617307|OTHER||Pearson's R|-0.108||||0.659|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 baseline scores||||0.659
73870148|NCT01865448|147284178|SUPERIORITY_OR_OTHER|||||||0.0404|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0404
74032049|NCT02749721|147617307|OTHER||Pearson's R|0.125||||0.611|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a baseline scores||||0.611
74032050|NCT02749721|147617307|OTHER||Pearson's R|-0.111||||0.671|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MADRS (baseline to endpoint percent change)||||0.671
74032051|NCT02749721|147617307|OTHER||Pearson's R|-0.026||||0.931|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MADRS (baseline to endpoint percent change)||||0.931
74032052|NCT02749721|147617307|OTHER||Pearson's R|0.516||||0.155|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MADRS (baseline to endpoint percent change)||||0.155
74032053|NCT02749721|147617307|OTHER||Pearson's R|0.268||||0.297|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MADRS (baseline to endpoint percent change)||||0.297
74032054|NCT02749721|147617307|OTHER||Pearson's R|0.184||||0.494|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MADRS (baseline to endpoint percent change)||||0.494
74032055|NCT02749721|147617307|OTHER||Pearson's R|-0.065||||0.811|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and DSST (baseline to endpoint percent change)||||0.811
74032056|NCT02749721|147617307|OTHER||Pearson's R|-0.048||||0.877|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and DSST (baseline to endpoint percent change)||||0.877
74032057|NCT02749721|147617307|OTHER||Pearson's R|-0.246||||0.557|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and DSST (baseline to endpoint percent change)||||0.557
74032058|NCT02749721|147617307|OTHER||Pearson's R|0.182||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and DSST (baseline to endpoint percent change)||||0.500
73958443|NCT05046132|147452018|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-0.3|2.9||||||4 hr post dose||2.9|-0.3|
74032059|NCT02749721|147617307|OTHER||Pearson's R|0.288||||0.297|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and DSST (baseline to endpoint percent change)||||0.297
74039477|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3906|TWO_SIDED|95.0|-0.99|0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.39|-0.99|0.3906
73946932|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|132.6||||0.1684|TWO_SIDED|95.0|-57.4|322.6|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 1||322.6|-57.4|0.1684
73946933|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-90.4||||0.5122|TWO_SIDED|95.0|-364.7|184.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 2||184.0|-364.7|0.5122
73946934|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-75.5||||0.5417|TWO_SIDED|95.0|-321.7|170.7|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 2||170.7|-321.7|0.5417
73946935|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.4||||0.6511|TWO_SIDED|95.0|-294.2|185.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 2||185.3|-294.2|0.6511
73946936|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.7||||0.6117|TWO_SIDED|95.0|-189.1|318.5|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 2||318.5|-189.1|0.6117
73946937|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-99.7||||0.3882|TWO_SIDED|95.0|-329.3|129.9|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 2||129.9|-329.3|0.3882
73946938|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-125.5||||0.4781|TWO_SIDED|95.0|-477.5|226.5|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH effect||226.5|-477.5|0.4781
73946939|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-277.9||||0.0834|TWO_SIDED|95.0|-593.7|37.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH effect||37.9|-593.7|0.0834
73946940|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|121.7||||0.4313|TWO_SIDED|95.0|-185.8|429.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH effect||429.3|-185.8|0.4313
73946941|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-73.5||||0.6528|TWO_SIDED|95.0|-399.1|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH effect||252.0|-399.1|0.6528
73946942|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-248.5||||0.0966|TWO_SIDED|95.0|-542.9|46.0|||Mixed Models Analysis|||Placebo versus Asacol for ACTH effect||46.0|-542.9|0.0966
73946943|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.2||||0.7704|TWO_SIDED|95.0|-187.6|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH morning||252.0|-187.6|0.7704
73946944|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|165.3||||0.0988|TWO_SIDED|95.0|-32.0|362.5|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH morning||362.5|-32.0|0.0988
73946945|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-153.4||||0.1153|TWO_SIDED|95.0|-345.5|38.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH morning||38.7|-345.5|0.1153
73946946|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.7||||0.9636|TWO_SIDED|95.0|-198.7|208.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH morning||208.0|-198.7|0.9636
73946947|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|119.8||||0.1972|TWO_SIDED|95.0|-64.1|303.8|||Mixed Models Analysis|||Placebo versus Asacol for ACTH morning||303.8|-64.1|0.1972
73870149|NCT01865448|147284178|SUPERIORITY_OR_OTHER|||||||0.0474|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0474
73946948|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-207.6||||0.0495|TWO_SIDED|95.0|-414.6|-0.5|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 1||-0.5|-414.6|0.0495
73946949|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.5||||0.9333|TWO_SIDED|95.0|-210.4|193.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 1||193.4|-210.4|0.9333
73946950|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-317.7||||0.0025|TWO_SIDED|95.0|-519.6|-115.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 1||-115.8|-519.6|0.0025
73946951|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.9823|TWO_SIDED|95.0|-204.1|199.6|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 1||199.6|-204.1|0.9823
73946952|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.3||||0.946|TWO_SIDED|95.0|-265.0|283.7|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 2||283.7|-265.0|0.9460
73946953|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.2||||0.8445|TWO_SIDED|95.0|-222.0|270.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 2||270.4|-222.0|0.8445
73946954|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.3||||0.7069|TWO_SIDED|95.0|-194.5|285.0|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 2||285.0|-194.5|0.7069
73946955|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|164.4||||0.1998|TWO_SIDED|95.0|-89.4|418.2|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 2||418.2|-89.4|0.1998
73946956|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|123.0||||0.4871|TWO_SIDED|95.0|-229.0|474.9|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH effect||474.9|-229.0|0.4871
73946957|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.4||||0.8527|TWO_SIDED|95.0|-345.2|286.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH effect||286.4|-345.2|0.8527
73946958|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|370.2||||0.0192|TWO_SIDED|95.0|62.6|677.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH effect||677.8|62.6|0.0192
73946959|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|174.9||||0.2865|TWO_SIDED|95.0|-150.6|500.5|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH effect||500.5|-150.6|0.2865
73946960|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.6||||0.4279|TWO_SIDED|95.0|-307.5|132.2|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH morning||132.2|-307.5|0.4279
73946961|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.4||||0.6464|TWO_SIDED|95.0|-151.8|242.7|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH morning||242.7|-151.8|0.6464
73946962|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-273.3||||0.0061|TWO_SIDED|95.0|-465.4|-81.2|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH morning||-81.2|-465.4|0.0061
73946963|NCT01036022|147426300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-115.2||||0.2614|TWO_SIDED|95.0|-318.5|88.1|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH morning||88.1|-318.5|0.2614
73958444|NCT05046132|147452018|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-2.2|2.0||||||5 hr post dose||2.0|-2.2|
73870150|NCT01865448|147284179|SUPERIORITY_OR_OTHER|||||||0.3187|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.3187
73870151|NCT01865448|147284179|SUPERIORITY_OR_OTHER|||||||0.0482|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0482
73870152|NCT01865448|147284179|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0394
73870153|NCT01865448|147284180|SUPERIORITY_OR_OTHER|||||||0.2813|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2813
73870154|NCT01865448|147284180|SUPERIORITY_OR_OTHER|||||||0.4421|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4421
73870155|NCT01865448|147284180|SUPERIORITY_OR_OTHER|||||||0.3198|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3198
73946964|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.7559|TWO_SIDED|95.0|-2.0|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 1 SCCAI score||1.5|-2.0|0.7559
73946965|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.1238|TWO_SIDED|95.0|-0.4|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 1 SCCAI score||3.2|-0.4|0.1238
74032060|NCT02749721|147617307|OTHER|Differences in BNA scores between MDD and healthy subjects were analyzed for baseline visits using an ANCOVA model with group as a factor, and age as a covariate.|F statistic|0.318||||0.575|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.575
73870156|NCT01865448|147284181|SUPERIORITY_OR_OTHER|||||||0.2792|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2792
73870157|NCT01865448|147284181|SUPERIORITY_OR_OTHER|||||||0.1034|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1034
73870158|NCT01865448|147284181|SUPERIORITY_OR_OTHER|||||||0.9898|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.9898
73870159|NCT01865448|147284182|SUPERIORITY_OR_OTHER|||||||0.7047|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7047
73870160|NCT01865448|147284182|SUPERIORITY_OR_OTHER|||||||0.4749|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4749
73870161|NCT01865448|147284182|SUPERIORITY_OR_OTHER|||||||0.6014|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.6014
73870162|NCT01865448|147284183|SUPERIORITY_OR_OTHER|||||||0.5932|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.5932
73870163|NCT01865448|147284183|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.7140
73870164|NCT01865448|147284183|SUPERIORITY_OR_OTHER|||||||0.5827|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5827
73870165|NCT01865448|147284184|SUPERIORITY_OR_OTHER|||||||0.2894|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2894
73870166|NCT01865448|147284184|SUPERIORITY_OR_OTHER|||||||0.2128|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2128
73870167|NCT01865448|147284184|SUPERIORITY_OR_OTHER|||||||0.0823|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0823
73870168|NCT01865448|147284185|SUPERIORITY_OR_OTHER|||||||0.345|||||||ANCOVA|||Between-Group Comparison||||0.3450
73870169|NCT01865448|147284185|SUPERIORITY_OR_OTHER|||||||0.1365|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1365
73870170|NCT01865448|147284185|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0073
73870171|NCT01865448|147284186|SUPERIORITY_OR_OTHER|||||||0.2333|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2333
73870172|NCT01865448|147284186|SUPERIORITY_OR_OTHER|||||||0.4292|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4292
73870173|NCT01865448|147284186|SUPERIORITY_OR_OTHER|||||||0.3356|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3356
73870174|NCT01865448|147284187|SUPERIORITY_OR_OTHER|||||||0.683|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6830
73870175|NCT01865448|147284187|SUPERIORITY_OR_OTHER|||||||0.8625|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.8625
73870176|NCT01865448|147284187|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0068
73870177|NCT01865448|147284188|SUPERIORITY_OR_OTHER|||||||0.3694|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.3694
73870178|NCT01865448|147284188|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0291
73870179|NCT01865448|147284188|SUPERIORITY_OR_OTHER|||||||0.0402|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0402
73870180|NCT01865448|147284189|SUPERIORITY_OR_OTHER|||||||0.1226|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1226
73870181|NCT01865448|147284189|SUPERIORITY_OR_OTHER|||||||0.0472|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0472
73870182|NCT01865448|147284189|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0197
73870183|NCT01865448|147284190|SUPERIORITY_OR_OTHER|||||||0.8969|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8969
73870184|NCT01865448|147284190|SUPERIORITY_OR_OTHER|||||||0.7218|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.7218
73870185|NCT01865448|147284190|SUPERIORITY_OR_OTHER|||||||0.4536|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4536
73870186|NCT01865448|147284191|SUPERIORITY_OR_OTHER|||||||0.8765|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8765
73958445|NCT05046132|147452018|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.8|2.3||||||6 hr post dose||2.3|-0.8|
73958446|NCT05046132|147452018|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.8|2.7||||||7 hr post dose||2.7|-0.8|
73946966|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.6302|TWO_SIDED|95.0|-1.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 1 SCCAI score||2.2|-1.3|0.6302
73946967|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.2777|TWO_SIDED|95.0|-0.8|2.8|||Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 1 SCCAI score||2.8|-0.8|0.2777
73946968|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8069|TWO_SIDED|95.0|-1.4|1.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 1 SCCAI score||1.8|-1.4|0.8069
73870187|NCT01865448|147284191|SUPERIORITY_OR_OTHER|||||||0.5114|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5114
73946969|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.7699|TWO_SIDED|95.0|-1.6|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 2 SCCAI score||2.2|-1.6|0.7699
73946970|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3869|TWO_SIDED|95.0|-1.1|2.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 2 SCCAI score||2.8|-1.1|0.3869
73976326|NCT01759862|147498224|SUPERIORITY|Enrolling 25 patients in each group will allow us to detect a difference of 200ng/mg cr in urinary NGAL levels between the two groups with a power of 80% and a two-sided type I probability error of 0.05.||||||0.95|||||||Kruskal-Wallis|||||||0.95
73976327|NCT01759862|147498225|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||0.67
73976328|NCT00731614|147498226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322|||||||Repeated Measure ANOVA|||Conducted a repeated measures ANOVA comparing CBT+mirror retraining with Supportive Therapy across 11 time points. The primary hypothesis was a group by time interaction. Due to missing data, a total of 9 and 14 participants, respectively could be included in analyses.||||.322
73976329|NCT02628626|147498243|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
73946971|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.6695|TWO_SIDED|95.0|-2.4|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 2 SCCAI score||1.5|-2.4|0.6695
73976330|NCT02628626|147498244|SUPERIORITY|||||||0.24|||||||ANCOVA|||Approximately 4 weeks||||0.24
73976331|NCT02628626|147498245|SUPERIORITY|||||||0.44|||||||ANCOVA|||Approximately 4 weeks||||0.44
73976332|NCT02628626|147498246|SUPERIORITY|||||||0.35|||||||ANCOVA|||||||0.35
73976333|NCT02628626|147498247|SUPERIORITY|||||||0.56|||||||ANCOVA|||Approximately 4 weeks||||0.56
74032061|NCT02749721|147617307|OTHER||F statistic|0.378||||0.541|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.541
74032062|NCT02749721|147617307|OTHER||F|0.012||||0.912|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.912
73870188|NCT01865448|147284191|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0237
73870189|NCT01865448|147284192|SUPERIORITY_OR_OTHER|||||||0.2914|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2914
73870190|NCT01865448|147284192|SUPERIORITY_OR_OTHER|||||||0.5594|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5594
73870191|NCT01865448|147284192|SUPERIORITY_OR_OTHER|||||||0.2532|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2532
73870192|NCT01865448|147284193|SUPERIORITY_OR_OTHER|||||||0.0528|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0528
73946972|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.5152|TWO_SIDED|95.0|-1.4|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 2 SCCAI score||2.7|-1.4|0.5152
73946973|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.4507|TWO_SIDED|95.0|-2.4|1.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 2 SCCAI score||1.1|-2.4|0.4507
73946974|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8707|TWO_SIDED|95.0|-1.9|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 3 SCCAI score||2.3|-1.9|0.8707
73976334|NCT02628626|147498248|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
73976335|NCT02628626|147498249|SUPERIORITY|||||||0.11|||||||ANCOVA|||Small (staining only)||||0.11
73976336|NCT02628626|147498249|SUPERIORITY|||||||0.06|||||||ANCOVA|||Moderate (requires change of underwear)||||0.06
73976337|NCT02628626|147498249|SUPERIORITY|||||||0.36|||||||ANCOVA|||Large (requires complete change of clothes)||||0.36
73976338|NCT02628626|147498250|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
73976339|NCT02628626|147498251|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
73976340|NCT02628626|147498252|SUPERIORITY|||||||0.29|||||||ANCOVA|||||||0.29
73976341|NCT02628626|147498253|SUPERIORITY|||||||0.39|||||||ANCOVA|||||||0.39
73976342|NCT02628626|147498254|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
73976343|NCT02628626|147498255|SUPERIORITY|approximately 4 weeks post-treatment||||||0.12|||||||ANCOVA|||||||0.12
73976344|NCT02628626|147498256|SUPERIORITY|||||||0.67|||||||ANCOVA|||Lifestyle Score||||0.67
73946975|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.2915|TWO_SIDED|95.0|-0.9|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 3 SCCAI score||3.1|-0.9|0.2915
73946976|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.7251|TWO_SIDED|95.0|-2.4|1.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 3 SCCAI score||1.7|-2.4|0.7251
73976345|NCT02628626|147498256|SUPERIORITY|||||||0.8|||||||ANCOVA|||Coping Score||||0.80
73976346|NCT02628626|147498256|SUPERIORITY|||||||0.49|||||||ANCOVA|||Depression Score||||0.49
73976347|NCT02628626|147498256|SUPERIORITY|||||||0.6|||||||ANCOVA|||Embarrassment Score||||0.60
73976348|NCT02628626|147498257|SUPERIORITY|||||||0.78|||||||ANCOVA|||Approximately 4 weeks post-treatment||||0.78
73976349|NCT02063659|147498279|SUPERIORITY||Hodges-Lehman estimator of difference|-53.955|||<|0.001|TWO_SIDED|95.0|-84.955|-25.119|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.|-25.119|-84.955|< 0.001
73976350|NCT02063659|147498279|SUPERIORITY||Hodges-Lehman estimator of difference|-89.662|||<|0.001|TWO_SIDED|95.0|-113.104|-63.863|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.|-63.863|-113.104|< 0.001
74089267|NCT02697773|147731611|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0008|TWO_SIDED|95.0|1.33|2.95|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.95|1.33|0.0008
73946977|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4556|TWO_SIDED|95.0|-1.3|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 3 SCCAI score||2.9|-1.3|0.4556
73946978|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.662|TWO_SIDED|95.0|-2.3|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 3 SCCAI score||1.4|-2.3|0.6620
73946979|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2844|TWO_SIDED|95.0|-1.1|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 4 SCCAI score||3.5|-1.1|0.2844
73946980|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2799|TWO_SIDED|95.0|-1.0|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 4 SCCAI score||3.5|-1.0|0.2799
73976351|NCT01532999|147498287|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks. Data structure involved repeated measures over time nested within participant, who in turn, was nested within a therapy group. Models included a random intercept, a random slope, and fixed effects for treatment condition, time, and the stratification variable (site). Rejection of the null hypothesis of no treatment effect if this interaction was statistically significant (two-tailed α = .05).||||0.5
73976352|NCT01532999|147498288|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.57
73976353|NCT01532999|147498290|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.4
73976354|NCT01532999|147498291|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.8
73976355|NCT01532999|147498292|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.4
73976356|NCT01532999|147498293|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.35
73976357|NCT01532999|147498294|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Regression, Logistic|||Mixed effects logistic regression analysis.||||0.3
73976358|NCT01532999|147498295|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Regression, Logistic|||Mixed effects logistic regression analysis.||||0.7
73976359|NCT01093612|147498296|OTHER||||||<|0.001|||||||Wilcoxon rank-sum|||||||<0.001
73976360|NCT01093612|147498297|OTHER||||||<|0.001|||||||Wilcoxon rank-sum|||||||<0.001
73976361|NCT02921555|147498307|SUPERIORITY||Mean Difference (Final Values)|16.2||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
73976362|NCT02921555|147498307|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
73946981|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.7655|TWO_SIDED|95.0|-1.9|2.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 4 SCCAI score||2.6|-1.9|0.7655
73946982|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.3332|TWO_SIDED|95.0|-1.2|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 4 SCCAI score||3.5|-1.2|0.3332
74009071|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|1.27|STANDARD_ERROR_OF_MEAN|1.129||0.272|TWO_SIDED|80.0|-0.22|2.75|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.75|-0.22|0.272
73946983|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.6985|TWO_SIDED|95.0|-1.6|2.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 4 SCCAI score||2.4|-1.6|0.6985
73946984|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.3256|TWO_SIDED|95.0|-1.3|3.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 5 SCCAI score||3.7|-1.3|0.3256
73946985|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.65|TWO_SIDED|95.0|-1.9|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 5 SCCAI score||3.0|-1.9|0.6500
73946986|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8758|TWO_SIDED|95.0|-2.3|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 5 SCCAI score||2.7|-2.3|0.8758
73946987|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.7298|TWO_SIDED|95.0|-2.1|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 5 SCCAI score||3.0|-2.1|0.7298
73946988|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.5963|TWO_SIDED|95.0|-2.8|1.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 5 SCCAI score||1.6|-2.8|0.5963
73946989|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6498|TWO_SIDED|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 6 SCCAI score||3.1|-2.0|0.6498
73946990|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.7061|TWO_SIDED|95.0|-2.0|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 6 SCCAI score||3.0|-2.0|0.7061
73946991|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8549|TWO_SIDED|95.0|-2.7|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 6 SCCAI score||2.3|-2.7|0.8549
73946992|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6533|TWO_SIDED|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 6 SCCAI score||3.1|-2.0|0.6533
73946993|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.4378|TWO_SIDED|95.0|-3.1|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 6 SCCAI score||1.4|-3.1|0.4378
73946994|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.5917|TWO_SIDED|95.0|-2.2|1.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 1 SCCAI score||1.3|-2.2|0.5917
73946995|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.1764|TWO_SIDED|95.0|-0.5|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 1 SCCAI score||2.9|-0.5|0.1764
73946996|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7914|TWO_SIDED|95.0|-1.5|2.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 1 SCCAI score||2.0|-1.5|0.7914
73946997|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3578|TWO_SIDED|95.0|-0.9|2.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 1 SCCAI score||2.5|-0.9|0.3578
74009072|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|1.317||0.979|TWO_SIDED|80.0|-1.77|1.7|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.70|-1.77|0.979
74009073|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.201||0.568|TWO_SIDED|80.0|-2.27|0.88|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.88|-2.27|0.568
73946998|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.3247|TWO_SIDED|95.0|-1.0|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 2 SCCAI score||2.9|-1.0|0.3247
73946999|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1153|TWO_SIDED|95.0|-0.4|3.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 2 SCCAI score||3.4|-0.4|0.1153
73947000|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7995|TWO_SIDED|95.0|-1.7|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 2 SCCAI score||2.2|-1.7|0.7995
73947001|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.1786|TWO_SIDED|95.0|-0.6|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 2 SCCAI score||3.3|-0.6|0.1786
73947002|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.5824|TWO_SIDED|95.0|-1.5|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 3 SCCAI score||2.7|-1.5|0.5824
73947003|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1392|TWO_SIDED|95.0|-0.5|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 3 SCCAI score||3.5|-0.5|0.1392
73947004|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9665|TWO_SIDED|95.0|-2.0|2.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 3 SCCAI score||2.1|-2.0|0.9665
73947005|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2455|TWO_SIDED|95.0|-0.9|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 3 SCCAI score||3.3|-0.9|0.2455
73947006|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4644|TWO_SIDED|95.0|-1.4|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 4 SCCAI score||3.1|-1.4|0.4644
73947007|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4567|TWO_SIDED|95.0|-1.4|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 4 SCCAI score||3.0|-1.4|0.4567
73947008|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9594|TWO_SIDED|95.0|-2.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 4 SCCAI score||2.2|-2.3|0.9594
73947009|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.5122|TWO_SIDED|95.0|-1.5|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 4 SCCAI score||3.0|-1.5|0.5122
74032063|NCT02749721|147617307|OTHER||F statistic|1.586||||0.214|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.214
74032064|NCT02749721|147617307|OTHER||F statistic|0.453||||0.504|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.504
73947010|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.1493|TWO_SIDED|95.0|-0.7|4.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 5 SCCAI score||4.3|-0.7|0.1493
73947011|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.3478|TWO_SIDED|95.0|-1.3|3.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 5 SCCAI score||3.6|-1.3|0.3478
73947012|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.5238|TWO_SIDED|95.0|-1.7|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 5 SCCAI score||3.2|-1.7|0.5238
73947013|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.4091|TWO_SIDED|95.0|-1.4|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 5 SCCAI score||3.5|-1.4|0.4091
73947014|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.2604|TWO_SIDED|95.0|-1.1|4.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 6 SCCAI score||4.0|-1.1|0.2604
73958447|NCT05046132|147452018|OTHER||LS Mean|1.0|||||TWO_SIDED|90.0|-0.3|2.4||||||8 hr post dose||2.4|-0.3|
73958448|NCT05046132|147452018|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-0.7|2.9||||||9 hr post dose||2.9|-0.7|
73958449|NCT05046132|147452018|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.4|1.9||||||10 hr post dose||1.9|-1.4|
73958450|NCT05046132|147452018|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-0.6|3.2||||||12 hr post dose||3.2|-0.6|
73958451|NCT05046132|147452018|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.0|2.4||||||16 hr post dose||2.4|-1.0|
73958452|NCT05046132|147452018|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.0|4.2||||||24 hr post dose||4.2|-1.0|
73958453|NCT05046132|147452018|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-2.3|1.7||||||Pre dose||1.7|-2.3|
73958454|NCT05046132|147452018|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.6|1.3||||||0.5 hr post dose||1.3|-1.6|
73958455|NCT05046132|147452018|OTHER||LS Mean|-1.3|||||TWO_SIDED|90.0|-3.8|1.2||||||1 hr post dose||1.2|-3.8|
73958456|NCT05046132|147452018|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-1.7|1.8||||||1.5 hr post dose||1.8|-1.7|
73958457|NCT05046132|147452018|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-2.7|0.5||||||2 hr post dose||0.5|-2.7|
73958458|NCT05046132|147452018|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.8|2.3||||||2.5 hr post dose||2.3|-0.8|
73947015|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2809|TWO_SIDED|95.0|-1.1|3.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 6 SCCAI score||3.8|-1.1|0.2809
73947016|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6038|TWO_SIDED|95.0|-1.8|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 6 SCCAI score||3.1|-1.8|0.6038
73947017|NCT01036022|147426302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.2511|TWO_SIDED|95.0|-1.1|3.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 6 SCCAI score||3.9|-1.1|0.2511
73947018|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.75|||||TWO_SIDED|95.0|0.24|2.39||||||Placebo versus GSK1399686 10 mg for Week 1 fecal calprotectin levels||2.39|0.24|
73947019|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.21|1.92||||||Placebo versus GSK1399686 30 mg for Week 1 fecal calprotectin levels||1.92|0.21|
73947020|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.26|2.48||||||Placebo versus GSK1399686 100 mg for Week 1 fecal calprotectin levels||2.48|0.26|
73947021|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.27|2.68||||||Placebo versus GSK1399686 300 mg for Week 1 fecal calprotectin levels||2.68|0.27|
73947022|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.23|1.81||||||Placebo versus Asacol for Week 1 fecal calprotectin levels||1.81|0.23|
73947023|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.26|2.73||||||Placebo versus GSK1399686 10 mg for Week 2 fecal calprotectin levels||2.73|0.26|
73947024|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.55|||||TWO_SIDED|95.0|0.18|1.68||||||Placebo versus GSK1399686 30 mg for Week 2 fecal calprotectin levels||1.68|0.18|
73947025|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.21|2.18||||||Placebo versus GSK1399686 100 mg for Week 2 fecal calprotectin levels||2.18|0.21|
73947026|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.19|2.03||||||Placebo versus GSK1399686 300 mg for Week 2 fecal calprotectin levels||2.03|0.19|
73947027|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.22|1.9||||||Placebo versus Asacol for Week 2 fecal calprotectin levels||1.90|0.22|
74009074|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24|STANDARD_ERROR_OF_MEAN|1.201||0.311|TWO_SIDED|80.0|-0.34|2.82|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.82|-0.34|0.311
73947028|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|1.07|||||TWO_SIDED|95.0|0.28|4.09||||||Placebo versus GSK1399686 10 mg for Week 3 fecal calprotectin levels||4.09|0.28|
73947029|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.74|||||TWO_SIDED|95.0|0.23|2.43||||||Placebo versus GSK1399686 30 mg for Week 3 fecal calprotectin levels||2.43|0.23|
73947030|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.18|2.08||||||Placebo versus GSK1399686 100 mg for Week 3 fecal calprotectin levels||2.08|0.18|
73947031|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.6|||||TWO_SIDED|95.0|0.17|2.08||||||Placebo versus GSK1399686 300 mg for Week 3 fecal calprotectin levels||2.08|0.17|
73947032|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.15|1.32||||||Placebo versus Asacol for Week 3 fecal calprotectin levels||1.32|0.15|
73947033|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|1.29|||||TWO_SIDED|95.0|0.33|5.04||||||Placebo versus GSK1399686 10 mg for Week 4 fecal calprotectin levels||5.04|0.33|
73947034|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.2|2.02||||||Placebo versus GSK1399686 30 mg for Week 4 fecal calprotectin levels||2.02|0.20|
73947035|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.96|||||TWO_SIDED|95.0|0.29|3.23||||||Placebo versus GSK1399686 100 mg for Week 4 fecal calprotectin levels||3.23|0.29|
73947036|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|1.36|||||TWO_SIDED|95.0|0.39|4.72||||||Placebo versus GSK1399686 300 mg for Week 4 fecal calprotectin levels||4.72|0.39|
73947037|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.28|2.42||||||Placebo versus Asacol for Week 4 fecal calprotectin levels||2.42|0.28|
73947038|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.61|||||TWO_SIDED|95.0|0.14|2.66||||||Placebo versus GSK1399686 10 mg for Week 5 fecal calprotectin levels||2.66|0.14|
73947039|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|1.25|||||TWO_SIDED|95.0|0.35|4.38||||||Placebo versus GSK1399686 30 mg for Week 5 fecal calprotectin levels||4.38|0.35|
73947040|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.2|2.47||||||Placebo versus GSK1399686 100 mg for Week 5 fecal calprotectin levels||2.47|0.20|
73947041|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.41|||||TWO_SIDED|95.0|0.11|1.46||||||Placebo versus GSK1399686 300 mg for Week 5 fecal calprotectin levels||1.46|0.11|
73947042|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.47|||||TWO_SIDED|95.0|0.15|1.48||||||Placebo versus Asacol for Week 5 fecal calprotectin levels||1.48|0.15|
73947043|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.13|3.39||||||Placebo versus GSK1399686 10 mg for Week 6 fecal calprotectin levels||3.39|0.13|
74009075|NCT01301456|147568787|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.26||0.71|TWO_SIDED|80.0|-1.18|2.13|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.13|-1.18|0.710
74009076|NCT03593850|147568847|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
74009077|NCT03593850|147568848|EQUIVALENCE|Equivalence analysis was performed according to pre-defined significant difference of p \< 0.01||||||0.392|||||||t-test, 2 sided|||||||0.392
74009078|NCT03593850|147568849|EQUIVALENCE|Equivalence analysis was performed according to pre-defined significant difference of p \< 0.01||||||0.802|||||||t-test, 2 sided|||||||0.802
74009079|NCT03593850|147568850|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
74009080|NCT03593850|147568850|SUPERIORITY||Adjusted mean difference|1.429||||0.006|TWO_SIDED||||||ANCOVA|Fixed factors: group, covariates: pain before (VAS2), age in years, age at menarche, duration of menses, usual pain, anxiety before, hours with pain.|||Adjusted means: music 3.131 (99% CI 2.62, 3.999) and silence 4.56 (99% CI 3.581, 5.538), F= 8.44, R-square 54.5%|||0.006
73947044|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.11|1.84||||||Placebo versus GSK1399686 30 mg for Week 6 fecal calprotectin levels||1.84|0.11|
73947045|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.09|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal calprotectin levels||1.48|0.09|
73947046|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.76|||||TWO_SIDED|95.0|0.19|2.99||||||Placebo versus GSK1399686 300 mg for Week 6 fecal calprotectin levels||2.99|0.19|
73947047|NCT01036022|147426305|SUPERIORITY_OR_OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.21|2.49||||||Placebo versus Asacol for Week 6 fecal calprotectin levels||2.49|0.21|
73947048|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.19|||||TWO_SIDED|95.0|0.42|3.38||||||Placebo versus GSK1399686 10 mg for Week 1 fecal lactoferrin levels||3.38|0.42|
73947049|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.35|||||TWO_SIDED|95.0|0.5|3.65||||||Placebo versus GSK1399686 30 mg for Week 1 fecal lactoferrin levels||3.65|0.50|
73947050|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.25|||||TWO_SIDED|95.0|0.45|3.47||||||Placebo versus GSK1399686 100 mg for Week 1 fecal lactoferrin levels||3.47|0.45|
73947051|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.26|||||TWO_SIDED|95.0|0.44|3.59||||||Placebo versus GSK1399686 300 mg for Week 1 fecal lactoferrin levels||3.59|0.44|
73947052|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.28|||||TWO_SIDED|95.0|0.5|3.28||||||Placebo versus Asacol for Week 1 fecal lactoferrin levels||3.28|0.50|
73947053|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.76|||||TWO_SIDED|95.0|0.26|2.19||||||Placebo versus GSK1399686 10 mg for Week 2 fecal lactoferrin levels||2.19|0.26|
73947054|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.59|||||TWO_SIDED|95.0|0.22|1.63||||||Placebo versus GSK1399686 30 mg for Week 2 fecal lactoferrin levels||1.63|0.22|
73947055|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.35|||||TWO_SIDED|95.0|0.12|1.0||||||Placebo versus GSK1399686 100 mg for Week 2 fecal lactoferrin levels||1.00|0.12|
73947056|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.93|||||TWO_SIDED|95.0|0.31|2.77||||||Placebo versus GSK1399686 300 mg for Week 2 fecal lactoferrin levels||2.77|0.31|
73947057|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.7|||||TWO_SIDED|95.0|0.26|1.87||||||Placebo versus Asacol for Week 2 fecal lactoferrin levels||1.87|0.26|
73947058|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.53|||||TWO_SIDED|95.0|0.15|1.84||||||Placebo versus GSK1399686 10 mg for Week 3 fecal lactoferrin levels||1.84|0.15|
73947059|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.96|||||TWO_SIDED|95.0|0.32|2.87||||||Placebo versus GSK1399686 30 mg for Week 3 fecal lactoferrin levels||2.87|0.32|
73947060|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.52|||||TWO_SIDED|95.0|0.17|1.56||||||Placebo versus GSK1399686 100 mg for Week 3 fecal lactoferrin levels||1.56|0.17|
73947061|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.42|||||TWO_SIDED|95.0|0.45|4.46||||||Placebo versus GSK1399686 300 mg for Week 3 fecal lactoferrin levels||4.46|0.45|
73947062|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.14|1.01||||||Placebo versus Asacol for Week 3 fecal lactoferrin levels||1.01|0.14|
73947063|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.1|1.15||||||Placebo versus GSK1399686 10 mg for Week 4 fecal lactoferrin levels||1.15|0.10|
73947064|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.23|2.03||||||Placebo versus GSK1399686 30 mg for Week 4 fecal lactoferrin levels||2.03|0.23|
73947065|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.19|1.68||||||Placebo versus GSK1399686 100 mg for Week 4 fecal lactoferrin levels||1.68|0.19|
73947066|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.19|||||TWO_SIDED|95.0|0.38|3.7||||||Placebo versus GSK1399686 300 mg for Week 4 fecal lactoferrin levels||3.70|0.38|
73947067|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.26|1.89||||||Placebo versus Asacol for Week 4 fecal lactoferrin levels||1.89|0.26|
73947068|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.05|||||TWO_SIDED|95.0|0.27|4.07||||||Placebo versus GSK1399686 10 mg for Week 5 fecal lactoferrin levels||4.07|0.27|
73947069|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.48|||||TWO_SIDED|95.0|0.46|4.73||||||Placebo versus GSK1399686 30 mg for Week 5 fecal lactoferrin levels||4.73|0.46|
73947070|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.11|1.02||||||Placebo versus GSK1399686 100 mg for Week 5 fecal lactoferrin levels||1.02|0.11|
73947071|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.16|||||TWO_SIDED|95.0|0.36|3.73||||||Placebo versus GSK1399686 300 mg for Week 5 fecal lactoferrin levels||3.73|0.36|
73947072|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.29|2.33||||||Placebo versus Asacol for Week 5 fecal lactoferrin levels||2.33|0.29|
73947073|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.44|||||TWO_SIDED|95.0|0.31|6.59||||||Placebo versus GSK1399686 10 mg for Week 6 fecal lactoferrin levels||6.59|0.31|
73947074|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|2.21|||||TWO_SIDED|95.0|0.54|9.04||||||Placebo versus GSK1399686 30 mg for Week 6 fecal lactoferrin levels||9.04|0.54|
73947075|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.41|||||TWO_SIDED|95.0|0.11|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal lactoferrin levels||1.48|0.11|
73947076|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|1.64|||||TWO_SIDED|95.0|0.46|5.91||||||Placebo versus GSK1399686 300 mg for Week 6 fecal lactoferrin levels||5.91|0.46|
73947077|NCT01036022|147426306|SUPERIORITY_OR_OTHER||Ratio|0.84|||||TWO_SIDED|95.0|0.27|2.62||||||Placebo versus Asacol for Week 6 fecal lactoferrin levels||2.62|0.27|
73947078|NCT03300570|147426311|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
73958459|NCT05046132|147452018|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.3|1.8||||||3 hr post dose||1.8|-1.3|
73958460|NCT05046132|147452018|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.2|1.9||||||4 hr post dose||1.9|-1.2|
73958461|NCT05046132|147452018|OTHER||LS Mean|-1.5|||||TWO_SIDED|90.0|-3.5|0.5||||||5 hr post dose||0.5|-3.5|
73958462|NCT05046132|147452018|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.6|2.3||||||6 hr post dose||2.3|-0.6|
73958463|NCT05046132|147452018|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-1.3|2.1||||||7 hr post dose||2.1|-1.3|
73958464|NCT05046132|147452018|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|0.0|2.6||||||8 hr post dose||2.6|-0.0|
73958465|NCT05046132|147452018|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-1.3|2.2||||||9 hr post dose||2.2|-1.3|
73958466|NCT05046132|147452018|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-2.7|0.5||||||10 hr post dose||0.5|-2.7|
73958467|NCT05046132|147452018|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-2.1|1.5||||||12 hr post dose||1.5|-2.1|
73947079|NCT00576732|147426314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|2.18|<|0.001|TWO_SIDED|95.0|-12.19|-3.52||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone high dose arm minus change in placebo arm.|"A step-down testing procedure was employed with the risperidone high dose versus placebo comparison tested first. If this comparison was significant the risperidone low dose versus placebo comparison would be performed.~A clinically relevant difference in the change from baseline on the ABC Irritability subscale was assumed to be 6 with a standard deviation of 8. To achieve 80% power with Type I error rate of 5%, 93 subjects were required."||-3.52|-12.19|<0.001
73947080|NCT00576732|147426314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|2.17||0.164|TWO_SIDED|95.0|-7.36|1.27||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.|||1.27|-7.36|0.164
73947081|NCT00576732|147426315|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.004
73947082|NCT00576732|147426315|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.817
73947083|NCT00576732|147426316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.02|-0.33||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value.|Mean difference is change in Risperidone high dose arm minus change in placebo arm.|||-0.33|-1.02|<0.001
73947084|NCT00576732|147426316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.769|TWO_SIDED|95.0|-0.39|0.29||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.|||0.29|-0.39|0.769
73958468|NCT05046132|147452018|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.9|1.4||||||16 hr post dose||1.4|-1.9|
73870193|NCT01865448|147284193|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1920
73958469|NCT05046132|147452018|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-0.2|4.9||||||24 hr post dose||4.9|-0.2|
73958470|NCT03028363|147452076|OTHER|||||||0.343|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.3430
73958471|NCT03028363|147452077|OTHER|||||||0.126|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.1260
73958472|NCT03028363|147452078|OTHER|||||||0.5247|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation||||||0.5247
73958473|NCT00556543|147452082|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation performed.||||||0.19||95.0|||||Fisher Exact|||Fisher's Exact Test with the null hypothesis that the proportion with adverse events was the same in both groups.||||0.190
73958474|NCT01144182|147452103|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED|||||For this pilot study, significance level was set at p\<0.05|Wilcoxon (Mann-Whitney)|||||||.56
73958475|NCT01144182|147452104|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.22
73958476|NCT01144182|147452105|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
73958477|NCT01144182|147452106|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.34
73958478|NCT01144182|147452107|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.008
73958479|NCT01144182|147452108|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
73958480|NCT01144182|147452109|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.15
73958481|NCT01144182|147452110|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.55
73958482|NCT01144182|147452111|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.56
73958483|NCT01144182|147452112|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
73958484|NCT01144182|147452113|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.15
73958485|NCT01144182|147452114|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.26
73958486|NCT01144182|147452115|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.36
73958487|NCT02317016|147452116|NON_INFERIORITY_OR_EQUIVALENCE|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% confidence intervals (CIs) for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric least-squares (LS) mean ratio|171.92|||||TWO_SIDED|90.0|145.94|202.53|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed Cmax values were compared between treatments using a mixed effects analysis of variance (ANOVA) with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both area under the plasma concentration-time curve (AUC) and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.||202.53|145.94|
73958488|NCT02317016|147452117|NON_INFERIORITY_OR_EQUIVALENCE|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% CIs for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric LS Mean Ratio|134.63|||||TWO_SIDED|90.0|115.41|157.07|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed AUC values were compared between treatments using a mixed effects ANOVA with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both AUC and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.||157.07|115.41|
73958489|NCT00536380|147452130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.721||95.0|||||ANCOVA|||||||0.721
73870194|NCT01865448|147284193|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0011
73870195|NCT01865448|147284194|SUPERIORITY_OR_OTHER|||||||0.2999|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2999
73870196|NCT01865448|147284194|SUPERIORITY_OR_OTHER|||||||0.5184|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5184
73870197|NCT01865448|147284194|SUPERIORITY_OR_OTHER|||||||0.0564|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0564
73870198|NCT01865448|147284195|SUPERIORITY_OR_OTHER|||||||0.0783|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0783
73870199|NCT01865448|147284195|SUPERIORITY_OR_OTHER|||||||0.1263|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1263
73870200|NCT01865448|147284195|SUPERIORITY_OR_OTHER|||||||0.6484|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.6484
73870201|NCT01865448|147284196|SUPERIORITY_OR_OTHER|||||||0.6896|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6896
73870202|NCT01865448|147284196|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0980
73947085|NCT00576732|147426317|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||<0.001
73947086|NCT00576732|147426317|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.985
73947087|NCT00658138|147426347|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation done - pilot study|Mean Difference (Final Values)|0.05||||0.05|||||||Wilcoxon (Mann-Whitney)|||Hypothesis was no difference between adhesives tested at one year. Restorations were scored using USPHS subjective clinical criteria.||||0.05
73947088|NCT00658138|147426347|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation done - pilot study|percentage of Alpha values||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis is adhesives are not different in clinical performance at one year||||>0.05
73947089|NCT03238300|147426348|SUPERIORITY||partial eta squared|0.02|||>|0.05|TWO_SIDED|95.0|0.0|0.22||P-value \>0.05 for main effect of medication (N-acetylcysteine vs. placebo)|Mixed Models Analysis|Random intercepts were used||"With 31 participants, the study has 99% power to detect such effects on glutamate levels (calculated based on d =1.13 \[reported in Schmaal et al., 2012\], α = 0.05, two-tailed).~We used linear mixed effects models with random intercepts with medication, visit, and sequence. Baseline metabolite levels and brain tissue composition \[GM:BM = GM/(GM+WM)\], cannabis use (days), and alcohol use disorder status (Yes/No) were included as covariates."||0.22|0.00|>0.05
73870203|NCT01865448|147284196|SUPERIORITY_OR_OTHER|||||||0.3526|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3526
73947090|NCT03238300|147426349|SUPERIORITY||||||>|0.05||||||P-value \>0.05 for main effect of medication (N-acetylcysteine vs. placebo) for all ROIs.|Mixed Models Analysis|Random intercepts were used for all models.||Contrast of interest was alcohol beverages vs. non-alcohol beverages. We used linear mixed effects models with random intercepts with medication, visit, and sequence. Baseline reactivity levels for each ROI, cannabis use (days), and an alcohol use covariate (quantity, frequency, AUD status, or AUD severity - depending on which best fit the model) were included as covariates. ROIs included were (left and right hemisphere): amygdala, caudate, insula, putamen, and nucleus accumbens.||||>0.05
73870204|NCT01865448|147284197|SUPERIORITY_OR_OTHER|||||||0.9662|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9662
73870205|NCT01865448|147284197|SUPERIORITY_OR_OTHER|||||||0.145|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1450
73870206|NCT01865448|147284197|SUPERIORITY_OR_OTHER|||||||0.3811|TWO_SIDED||||||Paired t-test|||||||0.3811
73870207|NCT01865448|147284198|SUPERIORITY_OR_OTHER|||||||0.2643|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2643
73947091|NCT00186498|147426362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||Test of within subjects contrast: CVLT Long Delay Free Recall Time 1 (baseline) vs Time 2 (30 days): Placebo (F 4.093) p= 0.071; Memantine (F 35.042) p=0.006|Regression, Linear|||||||0.006
73947092|NCT03469284|147426363|OTHER|||||||0.0034|||||||ANOVA|||||||0.0034
73947093|NCT03469284|147426364|OTHER|||||||0.0008|||||||ANOVA|||||||0.0008
73947094|NCT03469284|147426366|OTHER|||||||0.9182|||||||Fisher Exact|||||||0.9182
73947095|NCT03469284|147426367|OTHER|||||||0.1046|||||||Fisher Exact|||||||0.1046
73947096|NCT01175148|147426368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15|||<|0.05|TWO_SIDED||||||Fisher Exact|||The study used a minimax Simon two-stage design to test the null hypothesis Ho: P \> 0.35 versus the alternative H1: \< 0.15, where P is the probability of grade 2 to 4 acute GVHD at day + 100.||||<0.05
73958490|NCT01670110|147452131|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
73870208|NCT01865448|147284198|SUPERIORITY_OR_OTHER|||||||0.0761|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0761
73870209|NCT01865448|147284198|SUPERIORITY_OR_OTHER|||||||0.1342|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.1342
73870210|NCT01865448|147284199|SUPERIORITY_OR_OTHER|||||||0.141|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1410
73870211|NCT01865448|147284199|SUPERIORITY_OR_OTHER|||||||0.3774|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3774
73870212|NCT01865448|147284199|SUPERIORITY_OR_OTHER|||||||0.1811|TWO_SIDED||||||Paired t-test|||||||0.1811
73870213|NCT01865448|147284200|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||<0.0001
73870214|NCT01865448|147284200|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
73870215|NCT01865448|147284200|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
73870216|NCT01865448|147284201|SUPERIORITY_OR_OTHER|||||||0.5893|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.5893
73870217|NCT01865448|147284201|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0431
73870218|NCT01865448|147284201|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0066
73947097|NCT01010477|147426369|SUPERIORITY_OR_OTHER|||||||0.632||||||threshold for statistical significance: p\< 0.05|Fisher Exact|||Fisher Exact test (2-sided)||||0.632
73947098|NCT00462670|147426371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.58|-0.6|||t-test, 2 sided|||||-0.60|-1.58|<0.0001
73947099|NCT00462670|147426372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.45|<|0.0001|TWO_SIDED|95.0|-2.54|-0.92|||t-test, 2 sided|||||-0.92|-2.54|<0.0001
73976363|NCT01586104|147498350|OTHER|With 20 patients, there is 80% power to detect a difference of 100% with Standard lung RT versus 93% with IMRT assuming a standard deviation of 8 (as seen for the whole heart), a one tailed test and a Bonferroni correction for 4 statistical tests so that each test is done at p\<0.0125.|||||<|0.0125||||||The reported p value was calculated. The statistical analysis performed is attached to the outcome measure reported.|Bonferroni corrected at p<0.0125|||Feasibility will be defined as an enrolled patient receiving the IMRT treatment as planned. It is expected that the treatment will be feasible in at least 90% of patients. If the treatment is feasible in 16 or more out of 20 patients, then the treatment will be declared feasible. If the true feasibility rate is 90%, then there is a 4.3% chance that 15 or fewer feasible patients will be observed.|Lung-metastases-free survival will be estimated using Kaplan-Meier survival curves (minimum period of six months).|||<0.0125
73976364|NCT04649047|147498353|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-2.92||||0.036|TWO_SIDED|95.0|-5.6|-0.23|||t-test, 2 sided|||||-0.23|-5.6|0.036
73947100|NCT02110732|147426373|OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
73947101|NCT02110732|147426374|SUPERIORITY||||||<|0.05|||||||Chi-squared||||Categorical variables were analyzed with Chi-square test or Fisher's exact test. Comparisons between groups were by Levene's test for equality of variances. A P-level \<0.05 was considered statistically significant. Data were analyzed with SPSS v.19 and NCSS.|||< 0.05
73947102|NCT02110732|147426375|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||< 0.05
73958491|NCT01670110|147452132|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
74009081|NCT03593850|147568851|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
74009082|NCT03593850|147568851|SUPERIORITY||Adjusted mean difference|0.721||||0.37|TWO_SIDED||||||ANCOVA|Fixed factor: Groups Covariates: Pain before, pain after, age, age menarche, menses duration, usual pain, anxiety before, anxiety after, hours pain|Adjusted means: music 2.58 (99% CI 1.339, 3.829), and silence 3.305 (1.728, 4.881); F 0.827, R-square 27.2%|||||0.370
74009083|NCT03593850|147568852|EQUIVALENCE|Equivalence between groups was pre-defined as p \> 0.01||||||0.377|||||||t-test, 2 sided|||||||0.377
73958492|NCT01670110|147452133|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
73958493|NCT01670110|147452134|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
73958494|NCT01670110|147452135|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73958495|NCT01670110|147452136|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73958496|NCT01670110|147452137|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
73958497|NCT01670110|147452138|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Physical functioning||||0.31
73958498|NCT01670110|147452138|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Physical role||||0.48
74009084|NCT03593850|147568853|SUPERIORITY|||||||0.049|||||||t-test, 2 sided|||||||0.049
74009085|NCT03593850|147568854|SUPERIORITY|||||||0.168|||||||t-test, 2 sided|||||||0.168
74009086|NCT03593850|147568855|EQUIVALENCE|Equivalence between groups was pre-defined as p \> 0.01||||||0.642|||||||Chi-squared|||||||0.642
74009087|NCT03593850|147568856|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
74009088|NCT03593850|147568857|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
74009089|NCT03593850|147568858|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.307|||||||t-test, 2 sided|||||||0.307
74009090|NCT03593850|147568859|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.318|||||||t-test, 2 sided|||||||0.318
74009091|NCT03593850|147568860|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.954|||||||t-test, 2 sided|||||||0.954
74009092|NCT03593850|147568861|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.258|||||||t-test, 2 sided|||||||0.258
74009093|NCT03593850|147568862|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
74009094|NCT03593850|147568863|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||||||0.056
74009095|NCT03593850|147568864|SUPERIORITY|||||||0.885|||||||t-test, 2 sided|||||||0.885
74009096|NCT03593850|147568865|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
74009097|NCT01735279|147568869|OTHER|Test t Student|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
74009098|NCT01735279|147568869|SUPERIORITY||Mean Difference (Final Values)|30.84|||<|0.01|ONE_SIDED|95.0|||||ANOVA|||||||<0.01
74009099|NCT01735279|147568869|SUPERIORITY||Mean Difference (Final Values)|0.002|||<|0.01|TWO_SIDED||||||t-test, 1 sided|||||||<0.01
74009100|NCT01735279|147568869|SUPERIORITY||Mean Difference (Final Values)|4.4|||<|0.01|ONE_SIDED||||||t-test, 1 sided|||||||<0.01
74009101|NCT02170779|147568870|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
74009102|NCT02170779|147568871|SUPERIORITY_OR_OTHER|||||||0.738|||||||Wilcoxon (Mann-Whitney)|||||||0.738
74009103|NCT02170779|147568872|SUPERIORITY_OR_OTHER|||||||0.8434|||||||Wilcoxon (Mann-Whitney)|||||||0.8434
74009104|NCT02170779|147568873|SUPERIORITY_OR_OTHER|||||||0.638|||||||Wilcoxon (Mann-Whitney)|||||||0.638
74009105|NCT02170779|147568874|SUPERIORITY_OR_OTHER|||||||0.492|||||||Wilcoxon (Mann-Whitney)|||||||0.492
74009106|NCT02170779|147568875|SUPERIORITY_OR_OTHER|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||This analysis refers to the physical component of the MSIS-29||||0.144
74009107|NCT02170779|147568875|SUPERIORITY_OR_OTHER|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||This refers to the psychological analysis for the MSIS-29.||||0.953
74009108|NCT02170779|147568876|SUPERIORITY_OR_OTHER|||||||0.915|||||||Wilcoxon (Mann-Whitney)|||||||0.915
74009109|NCT02170779|147568877|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||||||0.023
74009110|NCT02170779|147568878|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
74009111|NCT00369785|147568879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in immediate recall memory at 24 weeks||||.62
74032065|NCT02749721|147617307|OTHER||F statistic|0.37||||0.546|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.546
73947103|NCT02948959|147426394|SUPERIORITY|To control the type-I error rate for the analysis of outcome measure, a hierarchical testing procedure was applied at a 2-sided 5% significant level. Testing was then performed sequentially in the order endpoints were reported. Hierarchical testing sequence continued only if the previous endpoint was statistically significant.|Risk Ratio (RR)|0.353|||<|0.0001|TWO_SIDED|95.0|0.222|0.562||Threshold for statistical significance at 5% significant level.|Negative binomial model||Risk ratio, also called relative risk compares the risk (rate) of an event among one group with the risk (rate) among another group.|Risk ratio and p-value was derived using negative binomial model with total number of events onset from randomization up to Week 52 visit or last contact date (whichever comes earlier) as response variable, with treatment group, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level and number of severe exacerbation events within 1 year prior to study as covariates and log-transformed standardized observation duration as an offset variable.||0.562|0.222|<0.0001
74032066|NCT02749721|147617307|OTHER||F statistic|0.017||||0.895|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.895
73947104|NCT02948959|147426395|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|Risk Ratio (RR)|0.407|||<|0.0001|TWO_SIDED|95.0|0.274|0.605||Threshold for statistical significance at 5% significant level.|Negative binomial model||Risk ratio, also called relative risk compares the risk (rate) of an event among one group with the risk (rate) among another group.|Risk ratio and p-value was derived using negative binomial model with total number of events onset from randomization up to Week 52 visit or last contact date (whichever comes earlier) as response variable, with treatment group, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level and number of severe exacerbation events within 1 year prior to study as covariates and log-transformed standardized observation duration as an offset variable.||0.605|0.274|<0.0001
73947105|NCT02948959|147426396|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|5.32||||0.0036|TWO_SIDED|95.0|1.76|8.88||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by-visit interaction as covariates.||8.88|1.76|0.0036
73947106|NCT02948959|147426397|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|5.21||||0.0009|TWO_SIDED|95.0|2.14|8.27||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by visit interaction as covariates.||8.27|2.14|0.0009
73870219|NCT01865448|147284202|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||<0.0001
73958499|NCT01670110|147452138|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Bodily pain||||0.89
73958500|NCT01670110|147452138|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||General health||||0.18
73958501|NCT01670110|147452138|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Vitality||||0.28
73958502|NCT01670110|147452138|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Social functioning||||0.66
73958503|NCT01670110|147452138|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Role emotional||||0.43
73958504|NCT01670110|147452138|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Mental health||||0.51
73958505|NCT01768676|147452142|NON_INFERIORITY_OR_EQUIVALENCE|The difference in percentage of subjects with a \>/= 50% reduction from baseline to Week 26 in sperm concentration between treatment arms was analyzed using Cochran-Mantel-Haenszel method to account for the randomization stratification by baseline sperm concentration. If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-12.93|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|-21.56|-4.29|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||-4.29|-21.56|
73958506|NCT01768676|147452143|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-11.4|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-23.5|0.7|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||0.7|-23.5|
73958507|NCT01768676|147452144|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-1.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-4.2|1.3|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||1.3|-4.2|
73958508|NCT01768676|147452145|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-2.9|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-6.8|1.1|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||1.1|-6.8|
73958509|NCT01768676|147452146|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|95.0|0.0|0.0|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||0|0|
73976365|NCT04649047|147498354|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-0.56||||-0.77|TWO_SIDED|95.0|-1.02|-0.1|||t-test, 2 sided|||||-0.10|-1.02|-0.77
73976366|NCT04649047|147498355|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-3.42||||-0.51|TWO_SIDED|95.0|-7.69|0.85|||t-test, 2 sided|||||0.85|-7.69|-0.51
73976367|NCT04649047|147498356|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|0.85||||0.49|TWO_SIDED|95.0|-0.32|2.03|||t-test, 2 sided|||||2.03|-0.32|0.49
73947107|NCT02948959|147426398|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.26||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in ACQ-7-IA up to Week 52 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA and baseline-by-visit interaction as covariates.||-0.26|-0.66|<0.0001
73947108|NCT02948959|147426399|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-0.33||||0.0001|TWO_SIDED|95.0|-0.5|-0.16||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in ACQ-7-IA up to Week 52 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA and baseline-by-visit interaction as covariates.||-0.16|-0.50|0.0001
73947109|NCT02948959|147426400|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-20.59|||<|0.0001|TWO_SIDED|95.0|-24.6|-16.59||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.||-16.59|-24.60|<0.0001
73947110|NCT02948959|147426401|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-17.84|||<|0.0001|TWO_SIDED|95.0|-21.05|-14.63||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.||-14.63|-21.05|<0.0001
73947111|NCT03097861|147426471|OTHER|Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect|||||=|0.002|||||||ANCOVA|||||||=0.0020
73947112|NCT03097861|147426471|OTHER||||||<|0.0001|||||||ANCOVA|||Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect||||<0.0001
73976368|NCT04649047|147498357|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-8.54||||-0.48|TWO_SIDED|95.0|-19.9|2.82|||t-test, 2 sided|||||2.82|-19.9|-0.48
73947113|NCT00868699|147426478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
73947114|NCT00868699|147426478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
73976369|NCT04649047|147498358|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|64.46||||0.13|TWO_SIDED|95.0|-256.0|384.7|||t-test, 2 sided|||||384.7|-256|0.13
73976370|NCT04649047|147498359|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.5||||0.88|TWO_SIDED|95.0|0.98|6.02|||t-test, 2 sided|||||6.02|0.98|0.88
73870220|NCT01865448|147284202|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
73976371|NCT04649047|147498360|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|2.67||||0.61|TWO_SIDED|95.0|-0.1|4.94|||t-test, 2 sided|||||4.94|-0.10|0.61
73976372|NCT04649047|147498361|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|4.5||||0.78|TWO_SIDED|95.0|0.82|8.18|||t-test, 2 sided|||||8.18|0.82|0.78
73976373|NCT04649047|147498362|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.42||||0.58|TWO_SIDED|95.0|-0.32|7.16|||t-test, 2 sided|||||7.16|-0.32|0.58
73976374|NCT04649047|147498363|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|2.42||||0.61|TWO_SIDED|95.0|-0.1|4.94|||t-test, 2 sided|||||4.94|-0.10|0.61
73976375|NCT04649047|147498364|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.83||||0.46|TWO_SIDED|95.0|-1.5|9.16|||t-test, 2 sided|||||9.16|-1.50|0.46
73976376|NCT04649047|147498365|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|4.08||||0.71|TWO_SIDED|95.0|0.43|7.73|||t-test, 2 sided|||||7.73|0.43|0.71
73976377|NCT04649047|147498366|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-3.67||||-0.52|TWO_SIDED|95.0|-8.12|0.79|||t-test, 2 sided|||||0.79|-8.12|-0.52
73976378|NCT05037513|147498377|SUPERIORITY||Odds Ratio (OR)|7.06|||<|0.05|TWO_SIDED|95.0|0.8|62.2|||Regression, Logistic|||||62.2|0.8|<0.05
73976379|NCT05037513|147498378|SUPERIORITY||Odds Ratio (OR)|7.06|||<|0.05|TWO_SIDED|95.0|0.8|62.2|||Regression, Logistic|||||62.2|0.8|<0.05
73976380|NCT04001829|147498456|SUPERIORITY|||||||0.27|||||||Fisher Exact|||||||0.27
73976381|NCT04001829|147498457|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
73976382|NCT04001829|147498458|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
73976383|NCT04001829|147498459|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73976384|NCT04001829|147498460|SUPERIORITY|||||||0.019|||||||Fisher Exact|||||||0.019
73947115|NCT00868699|147426479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
73947116|NCT00868699|147426479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
73947117|NCT00868699|147426480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|1.05||0.003|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||0.003
73947118|NCT00868699|147426480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
73947119|NCT03885011|147426505|SUPERIORITY||Odds Ratio (OR)|1.103||||0.8445|TWO_SIDED|95.0|0.413|2.949|||Regression, Logistic|||This analysis relates to Day 8 up to when pilocarpine HCl 0.2% either in CSF-1-FDC or as pilocarpine alone was administered for one week.||2.949|0.413|0.8445
73976385|NCT04001829|147498461|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
73976386|NCT01737398|147498508|OTHER||Least Square Mean Difference|-19.73||||4e-08|TWO_SIDED|95.0|-26.43|-13.03|||MMRM|||||-13.03|-26.43|0.00000004
73976387|NCT01737398|147498509|OTHER||Least Square Mean Difference|-11.68||||0.0006|TWO_SIDED|95.0|-18.29|-5.06|||MMRM|||||-5.06|-18.29|0.0006
73976388|NCT00982072|147498552|OTHER|||||||0.12|||||||Fisher Exact|||||||0.12
73976389|NCT03244800|147498573|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73976390|NCT03244800|147498574|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
73976391|NCT03244800|147498575|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73947120|NCT03885011|147426505|SUPERIORITY||Odds Ratio (OR)|1.646||||0.266|TWO_SIDED|95.0|0.684|3.958|||Regression, Logistic|||||3.958|0.684|0.2660
73947121|NCT03885011|147426506|SUPERIORITY||Odds Ratio (OR)|3.664||||0.0015|TWO_SIDED|95.0|1.646|8.154|||Regression, Logistic|||||8.154|1.646|0.0015
73947122|NCT03885011|147426506|SUPERIORITY||Odds Ratio (OR)|4.745||||0.0002|TWO_SIDED|95.0|2.088|10.786|||Regression, Logistic|||||10.786|2.088|0.0002
73947123|NCT03885011|147426507|SUPERIORITY|||||||0.1145|||||||Chi-squared|||||||0.1145
73947124|NCT03885011|147426507|SUPERIORITY|||||||0.0616|||||||Chi-squared|||||||0.0616
73947125|NCT03885011|147426508|SUPERIORITY|||||||0.0074|||||||Chi-squared|||||||0.0074
73947126|NCT03885011|147426508|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
73947127|NCT01725386|147426513|SUPERIORITY_OR_OTHER|||||||0.895|||||||Log Rank (Mantel-Cox)|||||||0.895
73976392|NCT03244800|147498576|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73976393|NCT03244800|147498577|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
73976394|NCT03244800|147498578|SUPERIORITY||Odds Ratio (OR)|10.76||||0.04|TWO_SIDED|90.0|1.61|72.03|||Regression, Logistic|||||72.03|1.61|0.040
73976395|NCT03229408|147498654|SUPERIORITY||||||<|0.004|||||||Unpaired t-test, 2-Sided|||||||<0.004
73976396|NCT03229408|147498655|SUPERIORITY||||||<|0.03|||||||Unpaired T-test, 2-Sided|||||||<0.03
73976397|NCT03229408|147498656|SUPERIORITY|||||||0.18|||||||Unpaired t-test, 2-Sided|||||||0.180
73976398|NCT03229408|147498657|SUPERIORITY||||||<|0.002|||||||Unpaired T-test, 2-Sided|||||||<0.002
73976399|NCT03229408|147498658|SUPERIORITY||||||<|0.04|||||||Unpaired t-test, 2-Sided|||||||<0.04
73976400|NCT03229408|147498659|SUPERIORITY||||||<|0.003|||||||Unpaired t-test, 2-Sided|||||||<0.003
73976401|NCT03229408|147498660|SUPERIORITY||||||<|0.0004|||||||Unpaired t-test, 2-Sided|||||||<0.0004
73976402|NCT03229408|147498661|SUPERIORITY||||||<|0.007|||||||Unpaired t-test, 2-Sided|||||||<0.007
73976403|NCT03387189|147498707|SUPERIORITY|Alpha - 0.05|Odds Ratio (OR)|0.39||||0.031|TWO_SIDED|95.0|0.17|0.91|||Regression, Logistic|Adjusted for length of second stage cesarean section, fetal station, delivery method, use of instrumentation , parity, and gestational age|Y = Intervention + Time + Intervention\*Time + Covariates. Provided estimation parameter is the OR from the interaction term and can be interpreted as the differential change in odds of outcome from pre to post period associated with the intervention.|||0.91|0.17|0.031
73976404|NCT03387189|147498708|SUPERIORITY|Alpha - 0.05|Odds Ratio (OR)|1.46||||0.465|TWO_SIDED|95.0|0.53|4.03|||Regression, Logistic|Adjusted for length of second stage cesarean section, fetal station, delivery method, use of instrumentation , parity, and gestational age|Y = Intervention + Time + Intervention\*Time + Covariates. Provided estimation parameter is the OR from the interaction term and can be interpreted as the differential change in odds of outcome from pre to post period associated with the intervention.|||4.03|0.53|0.465
73976405|NCT03387189|147498709|SUPERIORITY|alpha - 0.05|Mean Difference (Final Values)|-11.4||||0.01|TWO_SIDED|95.0|-20.4|-2.5|||t-test, 2 sided|||||-2.5|-20.4|0.01
73976406|NCT03387189|147498710|SUPERIORITY|Alpha - 0.05|Mean Difference (Final Values)|-1.0||||0.75|TWO_SIDED|95.0|-76.0|5.5|||t-test, 2 sided|||||5.5|-76.0|0.75
73976407|NCT03387189|147498711|SUPERIORITY|Alpha - 0.05|Mean Difference (Final Values)|-0.5||||0.02|TWO_SIDED|95.0|-1.0|-0.1|||t-test, 2 sided|||||-0.1|-1.0|0.02
73976408|NCT03387189|147498714|SUPERIORITY|Alpha - 0.05|Risk Difference (RD)|0.116||||0.1|TWO_SIDED|95.0|-0.01|0.24|||Fisher Exact|||||0.24|-0.01|0.10
73976409|NCT03387189|147498716|SUPERIORITY|Alpha - 0.05|Risk Difference (RD)|0.028||||0.81|TWO_SIDED|95.0|-0.12|17.8|||Fisher Exact|||||17.8|-0.12|0.81
73976410|NCT03387189|147498717|SUPERIORITY|Alpha - 0.05|Risk Ratio (RR)|0.01||||1|TWO_SIDED|95.0|-0.11|0.13|||Fisher Exact|||||0.13|-0.11|1.0
73976411|NCT02350634|147498750|OTHER||Correlation coefficient|0.429|||<|0.001|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||<0.001
73976412|NCT02350634|147498751|OTHER||Correlation coefficient|0.681|||<|0.001|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||<0.001
73870221|NCT01865448|147284202|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
73870222|NCT01865448|147284203|SUPERIORITY_OR_OTHER|||||||0.985|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9850
73870223|NCT01865448|147284203|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0049
73870224|NCT01865448|147284203|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Paired t-test|||||||0.0062
73947128|NCT00152009|147426517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.0006
73947129|NCT00152009|147426517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.0005
73947130|NCT00152009|147426517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
73947131|NCT00152009|147426518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.025
73947132|NCT00152009|147426518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.035
73976413|NCT02350634|147498752|OTHER||Correlation coefficient|0.644||||0.00278|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.00278
73976414|NCT02350634|147498753|OTHER||Correlation coefficient|0.437||||0.12|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.12
73870225|NCT01865448|147284204|SUPERIORITY_OR_OTHER|||||||0.1946|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1946
73870226|NCT01865448|147284204|SUPERIORITY_OR_OTHER|||||||0.2337|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2337
73870227|NCT01865448|147284204|SUPERIORITY_OR_OTHER|||||||0.9188|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.9188
73870228|NCT01865448|147284205|SUPERIORITY_OR_OTHER|||||||0.7964|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7964
73870229|NCT01865448|147284205|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.7680
73870230|NCT01865448|147284205|SUPERIORITY_OR_OTHER|||||||0.5669|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5669
73870231|NCT01865448|147284206|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0320
73870232|NCT01865448|147284206|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0220
73870233|NCT01865448|147284206|SUPERIORITY_OR_OTHER|||||||0.4563|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4563
73870234|NCT01865448|147284207|SUPERIORITY_OR_OTHER|||||||0.72828|TWO_SIDED||||||Fisher Exact|||Between-Group Comparison||||0.72828
73870235|NCT03004911|147284237|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.740
73870236|NCT03004911|147284238|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.890
73870237|NCT03004911|147284239|SUPERIORITY|||||||0.747|||||||t-test, 2 sided|||||||0.747
73870238|NCT03004911|147284240|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
73870239|NCT03004911|147284241|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||||||0.459
73870240|NCT02610777|147284249|SUPERIORITY||Hazard Ratio (HR)|0.861||||0.464|TWO_SIDED|95.0|0.577|1.286||P-value is from an unstratified log-rank test.|Log Rank||Hazard Ratio (HR) was based on an unstratified Cox proportional hazard regression model with treatment as a factor.|||1.286|0.577|0.464
73870241|NCT02610777|147284250|SUPERIORITY||Hazard Ratio (HR)|0.706|||=|0.092|TWO_SIDED|95.0|0.469|1.061||P-value comparing EFS between treatment groups was based on the unstratified log-rank test.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|Event-Free Survival (EFS)||1.061|0.469|=0.092
73870242|NCT02610777|147284253|SUPERIORITY||Hazard Ratio (HR)|0.562|||=|0.267|TWO_SIDED|95.0|0.2|1.579||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio (HR) is based on an unstratified Cox proportional hazard regression model with treatment as a factor.|||1.579|0.200|=0.267
73870243|NCT02610777|147284254|SUPERIORITY||Absolute Rate Difference|9.61|||=|0.312|TWO_SIDED|95.0|-8.83|28.04||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||28.04|-8.83|=0.312
73947133|NCT00152009|147426518|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
73947134|NCT00152009|147426519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
73947135|NCT00152009|147426519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
73947136|NCT00152009|147426519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
73947137|NCT00152009|147426520|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73947138|NCT00152009|147426520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||Cochran-Mantel-Haenszel|||||||0.0016
73947139|NCT00152009|147426520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0001
73947140|NCT00152009|147426521|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73947141|NCT00152009|147426521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||95.0|||||Cochran-Mantel-Haenszel|||||||0.0013
73947142|NCT00152009|147426521|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73947143|NCT00152009|147426522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1438||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.1438
73947144|NCT00152009|147426522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1426||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.1426
73947145|NCT00152009|147426522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0191||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.0191
73947146|NCT05076149|147426541|NON_INFERIORITY|The non-inferiority margin represents a clinically acceptable loss of effectiveness that margin preserve at least 50% of the treatment effect of the active control (ELX/TEZ/IVA) compared to placebo, where the treatment effect is estimated by the lower bound of the 95% confidence interval (CI)|LS Mean difference|0.2|||<|0.0001|TWO_SIDED|95.0|-0.5|0.9|||Mixed Models Repeated Measures|||||0.9|-0.5|< 0.0001
73947147|NCT05076149|147426542|SUPERIORITY||LS Mean difference|-2.8|||=|0.0034|TWO_SIDED|95.0|-4.7|-0.9|||Mixed Models Repeated Measures|||||-0.9|-4.7|=0.0034
73947148|NCT05076149|147426543|OTHER||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.55|3.16|||Generalized Estimated Equation Model|||||3.16|1.55|< 0.0001
73976415|NCT02350634|147498754|OTHER||Correlation coefficient|0.324||||0.0712|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.0712
73976416|NCT02350634|147498755|OTHER||Correlation coefficient|0.564||||0.0958|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.0958
73976417|NCT02350634|147498756|OTHER||Correlation coefficient|-0.189||||0.558|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.558
73976418|NCT04241848|147498762|SUPERIORITY||||||=|0.007|||||||ANOVA|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.007
73947149|NCT05076149|147426544|OTHER||Odds Ratio (OR)|2.87|||<|0.0001|TWO_SIDED|95.0|2.0|4.12|||Generalized Estimated Equation Model|||||4.12|2.00|< 0.0001
73947150|NCT05096208|147426545|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.858|1.169|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in least-square (LS) means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.169|0.858|
73947151|NCT05096208|147426545|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.215|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.215|0.900|
73976419|NCT04241848|147498762|SUPERIORITY||||||=|0.24|||||||ANOVA|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.240
73947152|NCT05096208|147426545|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.886|1.232|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.232|0.886|
73947153|NCT05096208|147426545|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.905|1.261|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.261|0.905|
73947154|NCT05096208|147426545|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.953|1.336|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.336|0.953|
73947155|NCT05096208|147426545|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.884|1.262|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.262|0.884|
73947156|NCT02087501|147426549|OTHER||Sample proportion|0.0|||||TWO_SIDED|95.0|0.0|11.6|||||The CI is calculated based on Clopper-Pearson method|||11.6|0|
73947157|NCT02087501|147426549|OTHER||Sample proportion|0.0|||||TWO_SIDED|95.0|0.0|11.6||||||||11.6|0|
73947158|NCT02087501|147426550|OTHER||Sample proportion|100.0|||||TWO_SIDED|95.0|88.4|100.0|||||CI is calculated based on Clopper-Pearson method|||100|88.4|
73947159|NCT02087501|147426551|OTHER||Sample proportion|80.0|||||TWO_SIDED|95.0|61.0|92.0||||||||92|61|
73947160|NCT00094328|147426554|OTHER|One sample t-test|Mean Difference (Final Values)|-1.62||||0.278|TWO_SIDED|95.0|-4.72|1.48|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (cm/year) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.||1.48|-4.72|0.278
73947161|NCT00094328|147426555|OTHER|One sample t-test|Median Difference (Final Values)|-0.07||||0.882|TWO_SIDED|95.0|-1.15|1.0|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (SD units) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.||1.00|-1.15|0.882
73947162|NCT01483937|147426563|SUPERIORITY_OR_OTHER|||||||0.533||95.0|||||ANOVA|||||||.533
73947163|NCT01657266|147426629|SUPERIORITY_OR_OTHER|||||||1|||||||Pearson´s Chi-square test|||||||1.00
73947164|NCT00909428|147426637|SUPERIORITY||Z-Score|2.803||||0.005|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no change from baseline maximal tolerated cystometric capacity following 30 days of treatment with daily 10mg solifenacin succinate.||||.005
73947165|NCT03021668|147426638|EQUIVALENCE|Chi2 test was performed to analyze difference in rates of Surgical Site Infections (SSIs) between the two groups||||||0.003|||||||Chi-squared|||||||0.003
73947166|NCT03021668|147426639|EQUIVALENCE|Students' T-test was used to evaluate any difference in length of stay between the two groups.||||||0.23|||||||t-test, 2 sided|||||||0.23
73947167|NCT00116844|147426646|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||<0.001
73947168|NCT00116844|147426647|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||<0.001
73947169|NCT00116844|147426648|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Prescott's method|||||||<0.001
73947170|NCT00116844|147426649|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||0.800
73947171|NCT00116844|147426650|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||0.229
73947172|NCT00116844|147426651|SUPERIORITY_OR_OTHER|||||||0.0331||95.0|||||Prescott's method|||||||0.0331
73947173|NCT01933880|147426652|SUPERIORITY_OR_OTHER|||||||0.0387|||||||Signed Rank Sum Test|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group||||0.0387
73947174|NCT01933880|147426653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 1 for the OROS-MPH group||||<0.0001
73947175|NCT01933880|147426654|SUPERIORITY_OR_OTHER|||||||0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 2 for the OROS-MPH group||||0.0001
73947176|NCT01933880|147426655|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 3 for the OROS-MPH group||||<0.0001
73947177|NCT01933880|147426656|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 7 for the OROS-MPH group||||<0.0001
73947178|NCT01933880|147426657|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group||||<0.0001
73947179|NCT02395133|147426681|SUPERIORITY||Percent Change Difference|-14.83|||=|0.0001|TWO_SIDED|95.0|-22.34|-7.33|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-7.33|-22.34|= 0.0001
73947180|NCT02395133|147426681|SUPERIORITY||Percent Change Difference|-17.83|||<|0.0001|TWO_SIDED|95.0|-25.33|-10.34|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-10.34|-25.33|< 0.0001
73947181|NCT02395133|147426681|SUPERIORITY||Percent Change Difference|-21.61|||<|0.0001|TWO_SIDED|95.0|-28.36|-14.87|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-14.87|-28.36|<0.0001
73947182|NCT02395133|147426682|SUPERIORITY||Percentage difference|24.5|||=|0.004|TWO_SIDED|95.0|9.7|39.29||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||39.29|9.70|= 0.0040
73947183|NCT02395133|147426682|SUPERIORITY||Percentage difference|28.0|||=|0.0004|TWO_SIDED|95.0|13.32|42.58||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||42.58|13.32|= 0.0004
73947184|NCT02395133|147426682|SUPERIORITY||Percentage difference|41.2|||<|0.0001|TWO_SIDED|95.0|28.93|53.52||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||53.52|28.93|<0.0001
73976420|NCT04241848|147498762|SUPERIORITY||||||=|0.04|||||||t-test, 2 sided|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.04
74032067|NCT02749721|147617307|OTHER||F statistic|0.179||||0.673|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.673
73947185|NCT02395133|147426683|SUPERIORITY||Percentage difference|21.4|||=|0.013|TWO_SIDED|95.0|4.86|38.0||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||38.00|4.86|= 0.0130
73947186|NCT02395133|147426683|SUPERIORITY||Percentage difference|33.5|||=|0.0003|TWO_SIDED|95.0|17.38|49.72||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||49.72|17.38|= 0.0003
73947187|NCT02395133|147426683|SUPERIORITY||Percentage difference|42.1|||<|0.0001|TWO_SIDED|95.0|28.36|55.76||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||55.76|28.36|<0.0001
73947188|NCT02395133|147426684|SUPERIORITY||Percentage difference|18.5|||=|0.0209|TWO_SIDED|95.0|4.14|32.91||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||32.91|4.14|= 0.0209
73947189|NCT02395133|147426684|SUPERIORITY||Percentage difference|29.7|||=|0.0007|TWO_SIDED|95.0|14.89|44.42||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||44.42|14.89|= 0.0007
73947190|NCT02395133|147426684|SUPERIORITY||Percentage difference|39.7|||<|0.0001|TWO_SIDED|95.0|27.42|51.95||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||51.95|27.42|<0.0001
73976421|NCT04241848|147498765|SUPERIORITY|||||||0.129|||||||ANOVA|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.129
73976422|NCT04241848|147498765|SUPERIORITY|||||||0.25|||||||ANOVA|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.250
73976423|NCT04241848|147498765|SUPERIORITY||||||=|0.073|||||||t-test, 2 sided|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.073
73976424|NCT04241848|147498766|SUPERIORITY||||||=|0.091|||||||ANOVA|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.091
73976425|NCT04241848|147498766|SUPERIORITY|||||||0.296|||||||ANOVA|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.296
74032068|NCT02749721|147617307|OTHER||F statistic|1.241||||0.27|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.27
73947191|NCT02395133|147426685|SUPERIORITY||Percentage difference|-14.4||||0.1048|TWO_SIDED|95.0|-29.21|0.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||0.32|-29.21|0.1048
73947192|NCT02395133|147426685|SUPERIORITY||Percentage difference|-20.6|||=|0.0107|TWO_SIDED|95.0|-35.32|-5.89||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||-5.89|-35.32|= 0.0107
73947193|NCT02395133|147426685|SUPERIORITY||Percentage difference|-36.1|||<|0.0001|TWO_SIDED|95.0|-48.4|-23.74||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||-23.74|-48.40|<0.0001
73947194|NCT00045435|147426712|OTHER||Percent|47.0|||||ONE_SIDED|95.0||69.0|||||The criterion for stopping was not met.|The study was to be stopped after 20 patients if the upper bound of a 1-sided 95% confidence interval for relapse-free survival was \<35%.||69||
73947195|NCT00045435|147426713|OTHER||percent|6.0|||||ONE_SIDED|80.0|1.0||||||The stopping criterion was not met.|The study was to be stopped if the lower bound of a 1-sided 80% confidence interval for NRM was greater than 15%|||1|
73947196|NCT03621202|147426733|OTHER||||||||||||||||||The EBBMS sensitivity was 100%.|||
73976426|NCT04241848|147498766|SUPERIORITY|||||||0.427|||||||t-test, 2 sided|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.427
73870244|NCT02610777|147284255|SUPERIORITY||Absolute Rate Difference|5.63||||0.56|TWO_SIDED|95.0|-13.19|24.44||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||24.44|-13.19|0.560
73870245|NCT02610777|147284256|SUPERIORITY||Absolute Rate Difference|8.64|||=|0.343|TWO_SIDED|95.0|-9.09|26.38||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||26.38|-9.09|=0.343
73870246|NCT02610777|147284257|SUPERIORITY||Absolute Rate Difference|-18.82|||=|0.296|TWO_SIDED|95.0|-52.91|15.26||P-value is from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||15.26|-52.91|=0.296
73870247|NCT02610777|147284258|SUPERIORITY||Absolute Rate Difference|13.16|||=|0.152|TWO_SIDED|95.0|-4.49|30.81||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||30.81|-4.49|=0.152
73870248|NCT02610777|147284259|SUPERIORITY||Absolute Rate Difference|10.53|||=|0.301|TWO_SIDED|95.0|-9.13|30.18||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||30.18|-9.13|=0.301
73870249|NCT02610777|147284260|SUPERIORITY||Absolute Rate Difference|13.16|||=|0.254|TWO_SIDED|95.0|-9.12|35.44||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||35.44|-9.12|=0.254
73976427|NCT04241848|147498767|SUPERIORITY|||||||0.063|||||||ANOVA|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.063
73976428|NCT04241848|147498767|SUPERIORITY|||||||0.447|||||||ANOVA|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.447
74032069|NCT02749721|147617307|OTHER||F statistic|0.042||||0.837|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.837
74032070|NCT02749721|147617308|OTHER||Pearson's R|0.359||||0.143|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 (Latency) baseline scores||||0.143
73870250|NCT02610777|147284261|SUPERIORITY||Absolute Rate Difference|-4.71|||=|0.787|TWO_SIDED|95.0|-38.33|28.92||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||28.92|-38.33|=0.787
73870251|NCT02610777|147284262|SUPERIORITY||Hazard Ratio (HR)|0.789|||=|0.62|TWO_SIDED|95.0|0.308|2.02||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||2.020|0.308|=0.620
73870252|NCT02610777|147284263|SUPERIORITY||Hazard Ratio (HR)|0.719|||=|0.436|TWO_SIDED|95.0|0.313|1.653||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||1.653|0.313|=0.436
73870253|NCT02610777|147284264|SUPERIORITY||Hazard Ratio (HR)|0.81|||=|0.565|TWO_SIDED|95.0|0.395|1.662||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||1.662|0.395|=0.565
73870254|NCT02610777|147284265|SUPERIORITY||Hazard Ratio (HR)|0.42|||=|0.383|TWO_SIDED|95.0|0.057|3.109||P-value comparing duration of CR in low blast AML between treatment groups is based on unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||3.109|0.057|=0.383
73870255|NCT02610777|147284266|SUPERIORITY||Hazard Ratio (HR)|1.206|||=|0.498|TWO_SIDED|95.0|0.699|2.081||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\>1 for the treatment indicates a shorter time to first CR, CRi or PR in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||2.081|0.699|=0.498
73870256|NCT02610777|147284267|SUPERIORITY||Hazard Ratio (HR)|0.905|||=|0.888|TWO_SIDED|95.0|0.226|3.62||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to Subsequent Therapy in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||3.620|0.226|=0.888
73870257|NCT02610777|147284268|SUPERIORITY||Absolute Rate Difference|19.231|||=|0.162|TWO_SIDED|95.0|-6.925|45.386||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With RBCs-transfusion Independence||45.386|-6.925|=0.162
73870258|NCT02610777|147284268|SUPERIORITY||Absolute Rate Difference|20.0|||=|0.454|TWO_SIDED|95.0|-26.381|66.381||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With Platelet-transfusion Independence||66.381|-26.381|=0.454
73870259|NCT02610777|147284270|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.266|TWO_SIDED|95.0|0.521|1.198||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to PD, Relapse, or Death in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||1.198|0.521|=0.266
73947197|NCT03621202|147426734|OTHER||||||||||||||||||The EBBMS specificity was 75%.|||
73947198|NCT02969525|147426769|OTHER||Correlation statistic|4.6|||=|0.031|||||||Cochran-Mantel-Haenszel|||"Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.~The 160 loading dose arm was not considered in the dose-response because this is a mixed dose and the test is examining linear dose response."||||=0.031
73947199|NCT02969525|147426769|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|4.2|||=|0.032|TWO_SIDED|95.0|1.13|15.23||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||15.23|1.13|=0.032
73947200|NCT02969525|147426769|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|8.1|||=|0.001|TWO_SIDED|95.0|2.28|28.74||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||28.74|2.28|=0.001
73947201|NCT02969525|147426769|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|9.7|||<|0.001|TWO_SIDED|95.0|2.73|34.26||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||34.26|2.73|<0.001
73947202|NCT02969525|147426769|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|3.7|||=|0.051|TWO_SIDED|95.0|1.0|13.68||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||13.68|1.00|=0.051
73947203|NCT02969525|147426770|OTHER||Odds Ratio (OR)|4.6|||=|0.002|TWO_SIDED|95.0|1.73|12.39||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||12.39|1.73|=0.002
73947204|NCT02969525|147426770|OTHER||Odds Ratio (OR)|11.0|||<|0.001|TWO_SIDED|95.0|3.91|30.95||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||30.95|3.91|<0.001
73947205|NCT02969525|147426770|OTHER||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|2.31|16.84||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||16.84|2.31|<0.001
73947206|NCT02969525|147426770|OTHER||Odds Ratio (OR)|4.2|||=|0.004|TWO_SIDED|95.0|1.59|11.35||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||11.35|1.59|=0.004
73947207|NCT02969525|147426771|OTHER||Odds Ratio (OR)|2.4|||=|0.279|TWO_SIDED|95.0|0.5|11.31||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||11.31|0.50|=0.279
73947208|NCT02969525|147426771|OTHER||Odds Ratio (OR)|4.1|||=|0.065|TWO_SIDED|95.0|0.92|17.88||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||17.88|0.92|=0.065
73976429|NCT04241848|147498767|SUPERIORITY|||||||0.096|||||||t-test, 2 sided|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.096
73976430|NCT04241848|147498768|SUPERIORITY|||||||0.035|||||||ANOVA|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.035
73976431|NCT04241848|147498768|SUPERIORITY||||||=|0.677|||||||ANOVA|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.677
73976432|NCT04241848|147498768|SUPERIORITY||||||=|0.022|||||||t-test, 2 sided|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.022
73870260|NCT03688074|147284315|OTHER||Ratio of Geometric LSMeans|0.15|||<|0.001|TWO_SIDED|90.0|0.06|0.35||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter : Eosinophils (cells/mm\^2)||95% CI (0.05, 0.41)|0.35|0.06|<0.001
73870261|NCT03688074|147284315|OTHER||Ratio of Geometric LSMeans|1.36||||0.106|TWO_SIDED|90.0|0.99|1.86||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Neutrophils (cells/mm\^2)||95% CI (0.94, 1.97)|1.86|0.99|0.106
73870262|NCT03688074|147284315|OTHER||Ratio of Geometric LSMeans|1.12||||0.389|TWO_SIDED|90.0|0.9|1.4||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: T cells CD3+ (cells/mm\^2)||95% CI (0.86, 1.46)|1.40|0.90|0.389
73870263|NCT03688074|147284315|OTHER||Ratio of Geometric LSMeans|1.18||||0.216|TWO_SIDED|90.0|0.94|1.48||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: T cells CD4+ (cells/mm\^2)||95% CI (0.90, 1.55)|1.48|0.94|0.216
73947209|NCT02969525|147426771|OTHER||Odds Ratio (OR)|7.5|||=|0.006|TWO_SIDED|95.0|1.77|31.28||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||31.28|1.77|=0.006
73976433|NCT04241848|147498769|SUPERIORITY||||||=|0.098|||||||ANOVA|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.098
73947210|NCT02969525|147426771|OTHER||Odds Ratio (OR)|2.9|||=|0.172|TWO_SIDED|95.0|0.63|13.39||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||13.39|0.63|=0.172
73947211|NCT03445065|147426796|SUPERIORITY||Mean Difference (Net)|-0.1||||0.341|TWO_SIDED|95.0|-0.4|0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The ANCOVA model included arm, centre, and type of diabetes as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference in HbA1c (%) at Day 180 was calculated as the Enabled group minus the Control group.|||0.1|-0.4|0.341
73947212|NCT03445065|147426797|SUPERIORITY||Mean Difference (Net)|-1.6||||0.03892|TWO_SIDED|95.0|-3.1|-0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The ANCOVA model included arm and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.1|-3.1|0.03892
73976434|NCT04241848|147498769|SUPERIORITY|||||||0.666|||||||ANOVA|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.666
73976435|NCT04241848|147498769|SUPERIORITY||||||=|0.007|||||||t-test, 2 sided|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.007
73976436|NCT04241848|147498770|SUPERIORITY||||||=|0.001|||||||ANOVA|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.001
74009112|NCT00369785|147568880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in discrimination memory between the two groups||||.007
74009113|NCT02367066|147568881|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.02||0.02|TWO_SIDED|80.0|0.9|0.98||1-sided|Mixed Models Analysis|||||0.98|0.90|0.02
74009114|NCT02367066|147568882|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.03||0.06|TWO_SIDED|80.0|0.92|0.99||1-sided|Mixed Models Analysis|||||0.99|0.92|0.06
73870264|NCT03688074|147284315|OTHER||Ratio of Geometric LSMeans|0.83||||0.26|TWO_SIDED|90.0|0.64|1.09||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Mast cells Tryptase+ (cells/mm\^2)||95% CI (0.61, 1.15)|1.09|0.64|0.260
73870265|NCT03688074|147284315|OTHER||Ratio of Geometric LSMeans|1.19||||0.546|TWO_SIDED|90.0|0.74|1.92||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Mast cells Chymase+ (cells/mm\^2)||95% CI (0.67, 2.10)|1.92|0.74|0.546
73870266|NCT00660179|147284318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.0108|TWO_SIDED|97.5|0.516|0.96|||Log Rank|||||0.960|0.516|0.0108
73870267|NCT00660179|147284318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.547|||<|0.0001|TWO_SIDED|97.5|0.392|0.762|||Log Rank|||||0.762|0.392|<0.0001
73870268|NCT00660179|147284319|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.669||||0.0146|TWO_SIDED|97.5|0.462|0.97|||Log Rank|||||0.970|0.462|0.0146
73870269|NCT00660179|147284319|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|97.5|0.335|0.747|||Log Rank|||||0.747|0.335|<0.0001
73870270|NCT00660179|147284320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.971||||0.9249|TWO_SIDED|97.5|0.477|1.976|||Log Rank|||||1.976|0.477|0.9249
73870271|NCT00660179|147284320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.638||||0.2037|TWO_SIDED|97.5|0.287|1.418|||Log Rank|||||1.418|0.287|0.2037
73870272|NCT00660179|147284321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046||||0.8312|TWO_SIDED|97.5|0.653|1.673|||Log Rank|||||1.673|0.653|0.8312
73870273|NCT00660179|147284321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.771||||0.2509|TWO_SIDED|97.5|0.464|1.282|||Log Rank|||||1.282|0.464|0.2509
73870274|NCT02255461|147284341|OTHER|Ordinal logistic regression model was built for outcome neutropenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.97|1.15||||||||1.15|0.97|
73947213|NCT03445065|147426801|SUPERIORITY||Mean Difference (Net)|5.4||||0.056|TWO_SIDED|95.0|-0.1|10.9||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm, centre, and diabetes type as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||10.9|-0.1|0.056
73947214|NCT03445065|147426801|SUPERIORITY||Mean Difference (Net)|4.7||||0.01255|TWO_SIDED|95.0|1.0|8.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||8.4|1.0|0.01255
73947215|NCT03445065|147426802|SUPERIORITY||Mean Difference (Net)|-5.5||||0.015|TWO_SIDED|95.0|-9.9|-1.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia \>250mg/dL Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-1.1|-9.9|0.015
73947216|NCT03445065|147426802|SUPERIORITY||Mean Difference (Net)|-1.0||||0.50266|TWO_SIDED|95.0|-4.0|2.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||2.0|-4.0|0.50266
73976437|NCT04241848|147498770|SUPERIORITY||||||=|0.009|||||||ANOVA|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.009
73976438|NCT04241848|147498770|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.018
73870275|NCT02255461|147284342|OTHER|Ordinal logistic regression model was built for outcome lymphopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.97|1.15||||||||1.15|0.97|
73870276|NCT02255461|147284343|OTHER|Ordinal logistic regression model was built for outcome leukopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|1.01|1.2||||||||1.20|1.01|
73870277|NCT05224453|147284377|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-5.0|||<|0.05|TWO_SIDED|95.0|-6.21|-3.78|||t-test, 2 sided|||||-3.78|-6.21|<0.05
73947217|NCT03445065|147426803|SUPERIORITY||Mean Difference (Net)|-5.1||||0.08|TWO_SIDED|95.0|-10.9|0.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia \>180mg/dL Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.6|-10.9|0.080
73976439|NCT03414684|147498801|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.88|TWO_SIDED|95.0|0.49|1.84|||Log Rank|stratified log rank test|Reference level is Arm B, such that hazard ratio corresponds to the effect of treatment on Arm A|||1.84|0.49|0.88
73976440|NCT03414684|147498802|SUPERIORITY||Odds Ratio (OR)|1.09||||1|TWO_SIDED|95.0|0.29|4.18|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to the effect of treatment on Arm A|||4.18|0.29|1
73976441|NCT03414684|147498804|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.49|TWO_SIDED|95.0|0.43|1.5|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||1.50|0.43|0.49
73976442|NCT03414684|147498805|SUPERIORITY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.32|3.43|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||3.43|0.32|1
73870278|NCT05224453|147284378|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-3.7|||<|0.05|TWO_SIDED|95.0|-6.53|-0.86|||t-test, 2 sided|||||-0.86|-6.53|<0.05
73870279|NCT05224453|147284378|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-1.7|||<|0.05|TWO_SIDED|95.0|-3.84|0.44|||t-test, 2 sided|||||0.44|-3.84|<0.05
73870280|NCT01128244|147284381|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|||||Threshold for significance P\<0.05|t-test, 2 sided|Paired t-test||||||0.20
73870281|NCT01128244|147284382|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||0.62
73870282|NCT01128244|147284383|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||<0.001
73870283|NCT01128244|147284384|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||0.45
73870284|NCT01128244|147284385|SUPERIORITY_OR_OTHER||Test of treatment effect.|0.05|||<|0.05|TWO_SIDED|||||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.|t-test, 2 sided|||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.||||<0.05
73870285|NCT06292130|147284399|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
73870286|NCT06292130|147284400|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
73870287|NCT02206035|147284411|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Comparison at Baseline||||0.95
73870288|NCT02206035|147284411|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||Comparison at Day 28||||0.26
73870289|NCT02206035|147284411|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Comparison at Day 100||||0.63
73870290|NCT02206035|147284411|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Comparison at Day 180||||0.76
73870291|NCT02206035|147284412|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Comparison at Baseline||||0.99
73870292|NCT02206035|147284412|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Comparison at Day 28||||0.48
73870293|NCT02206035|147284412|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
73870294|NCT02206035|147284412|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Comparison at Day 180||||0.96
73870295|NCT02206035|147284413|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Comparison at Baseline||||<0.001
73870296|NCT02206035|147284413|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Comparison at Day 28||||0.75
73870297|NCT02206035|147284413|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Comparison at Day 100||||0.28
73870298|NCT02206035|147284413|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Comparison at Day 180||||0.82
73947218|NCT03445065|147426803|SUPERIORITY||Mean Difference (Net)|-3.3||||0.10637|TWO_SIDED|95.0|-7.3|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-7.3|0.10637
73947219|NCT03445065|147426804|SUPERIORITY||Mean Difference (Net)|-0.2||||0.671|TWO_SIDED|95.0|-1.2|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-1.2|0.671
73947220|NCT03445065|147426804|SUPERIORITY||Mean Difference (Net)|-1.8||||0.12935|TWO_SIDED|95.0|-4.1|0.5||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.5|-4.1|0.12935
73947221|NCT03445065|147426805|SUPERIORITY||Mean Difference (Net)|-0.1||||0.693|TWO_SIDED|95.0|-0.6|0.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.4|-0.6|0.693
73947222|NCT03445065|147426806|SUPERIORITY||Mean Difference (Net)|-0.9||||0.753|TWO_SIDED|95.0|-6.7|4.9||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||4.9|-6.7|0.753
73947223|NCT03445065|147426806|SUPERIORITY||Mean Difference (Net)|-0.4||||0.84307|TWO_SIDED|95.0|-4.6|3.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effect, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.8|-4.6|0.84307
73947224|NCT03445065|147426807|SUPERIORITY||Mean Difference (Net)|-0.9||||0.653|TWO_SIDED|95.0|-4.8|3.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.0|-4.8|0.653
73947225|NCT03445065|147426807|SUPERIORITY||Mean Difference (Net)|2.3||||0.07261|TWO_SIDED|95.0|-0.2|4.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||4.8|-0.2|0.07261
73947226|NCT03445065|147426808|SUPERIORITY||Mean Difference (Net)|1.3||||0.685|TWO_SIDED|95.0|-4.9|7.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||7.4|-4.9|0.685
73947227|NCT03445065|147426808|SUPERIORITY||Mean Difference (Net)|3.1||||0.19785|TWO_SIDED|95.0|-1.6|7.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||7.8|-1.6|0.19785
73947228|NCT03445065|147426809|SUPERIORITY||Mean Difference (Net)|-0.4||||0.549|TWO_SIDED|95.0|-1.5|0.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.8|-1.5|0.549
73947229|NCT03445065|147426809|SUPERIORITY||Mean Difference (Net)|-3.3||||0.0318|TWO_SIDED|95.0|-6.3|-0.3||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.3|-6.3|0.03180
73947230|NCT03445065|147426810|SUPERIORITY||Mean Difference (Net)|0.1||||0.859|TWO_SIDED|95.0|-0.6|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-0.6|0.859
73976443|NCT03414684|147498806|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.36|TWO_SIDED|95.0|0.13|2.12|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||2.12|0.13|0.36
73976444|NCT03414684|147498807|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.68|TWO_SIDED|95.0|0.43|3.43|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||3.43|0.43|0.68
73976445|NCT03414684|147498808|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.27|TWO_SIDED|95.0|0.18|1.62|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||1.62|0.18|0.27
73947231|NCT03445065|147426810|SUPERIORITY||Mean Difference (Net)|-2.6||||0.01124|TWO_SIDED|95.0|-4.5|-0.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.6|-4.5|0.01124
73976446|NCT03414684|147498809|SUPERIORITY||Odds Ratio (OR)|0.81||||1|TWO_SIDED|95.0|0.08|7.78|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||7.78|0.08|1
73976447|NCT03414684|147498811|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.61|TWO_SIDED|95.0|0.26|2.16|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||2.16|0.26|0.61
73976448|NCT03414684|147498812|SUPERIORITY||Odds Ratio (OR)|0.79||||1|TWO_SIDED|95.0|0.1|5.93|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||5.93|0.10|1
74032071|NCT02749721|147617308|OTHER||Pearson's R|-0.197||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (latency) baseline scores||||0.500
74032072|NCT02749721|147617308|OTHER||Pearson's R|0.277||||0.337|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (latency) baseline scores||||0.337
73870299|NCT02206035|147284414|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||Comparison at Baseline||||0.54
73947232|NCT03445065|147426811|SUPERIORITY||Mean Difference (Net)|-0.802|STANDARD_ERROR_OF_MEAN|0.391||0.045|TWO_SIDED|95.0|-1.1585|-0.018||The significance level was set to p\<0.05 (two-sided).|Mixed Models Analysis|The model included time and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled (D150-180) group minus the Enabled (D90-120) group.|||-0.018|-1.1585|0.045
73947233|NCT03445065|147426812|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|1.54||0.763|TWO_SIDED|95.0|-2.741|3.682||The significance level was set to p\<0.05 (two-sided).|Mixed Model for Repeated Measures|The model included time and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Switch to Enabled (D150-180) group minus the Control (D90-120) group.|||3.682|-2.741|0.763
73947234|NCT03445065|147426813|SUPERIORITY||Mean Difference (Net)|1.3||||0.14|TWO_SIDED|95.0|-0.4|3.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.0|-0.4|0.140
73947235|NCT03445065|147426813|SUPERIORITY||Mean Difference (Net)|-0.5||||0.6411|TWO_SIDED|95.0|-2.6|1.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||1.6|-2.6|0.64110
73947236|NCT03445065|147426814|SUPERIORITY||Mean Difference (Net)|1.0||||0.339|TWO_SIDED|95.0|-1.1|3.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.1|-1.1|0.339
73947237|NCT03445065|147426814|SUPERIORITY||Mean Difference (Net)|-0.7||||0.57677|TWO_SIDED|95.0|-3.0|1.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||1.7|-3.0|0.57677
73947238|NCT03445065|147426815|SUPERIORITY||Mean Difference (Net)|-0.1||||0.558|TWO_SIDED|95.0|-0.3|0.2||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm, centre, and diabetes type as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.2|-0.3|0.558
73947239|NCT03445065|147426815|SUPERIORITY||Mean Difference (Net)|-0.1||||0.408|TWO_SIDED|95.0|-0.3|0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.1|-0.3|0.408
73947240|NCT03445065|147426816|SUPERIORITY||Mean Difference (Net)|0.1||||0.616|TWO_SIDED|95.0|-0.2|0.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference in HbA1c (%) at Day 180 was calculated as the Enabled group minus the Control group.|||0.4|-0.2|0.616
73947241|NCT02172625|147426838|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|26.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
73947242|NCT02172625|147426839|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|15.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
73947243|NCT02172625|147426843|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|24.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
73947244|NCT00524030|147426844|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||Null hypothesis (H0): Exit rate greater than or equal to (≥)74%||||<0.001
73947245|NCT00524030|147426844|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exite rate ≥68%||||<0.001
73976449|NCT03414684|147498814|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.73|TWO_SIDED|95.0|0.14|3.89|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||3.89|0.14|0.73
73976450|NCT04038580|147498829|SUPERIORITY|||||||0.553||||||Statistical significance was set a-priori at p\<0.05|ANOVA|||The null hypothesis was that all sockets would have the same SCS||||0.553
73947246|NCT00524030|147426845|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exit rate ≥74%||||<0.001
73976451|NCT04038580|147498830|SUPERIORITY|Frustration sub-scale||||||0.536|||||||ANOVA|||The null hypothesis was that all sockets would be the same||||0.536
73976452|NCT04038580|147498830|SUPERIORITY|Perceived Response||||||0.598|||||||ANOVA|||||||0.598
73976453|NCT04038580|147498830|SUPERIORITY|Social Burden||||||0.072|||||||ANOVA|||||||0.072
73976454|NCT04038580|147498830|SUPERIORITY|Ambulation Sub-scale||||||0.018|||||||ANOVA|||||||0.018
73976455|NCT04038580|147498830|SUPERIORITY|Prosthesis Utility||||||0.037|||||||ANOVA|||||||0.037
73976456|NCT04038580|147498830|SUPERIORITY|Residual Limb Health||||||0.254|||||||ANOVA|||||||0.254
73870300|NCT02206035|147284414|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Comparison at Day 28||||0.61
73870301|NCT02206035|147284414|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Comparison at Day 100||||0.42
73870302|NCT02206035|147284414|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||Comparison at Day 180||||0.38
73870303|NCT02206035|147284415|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Comparison at Baseline||||0.10
73870304|NCT02206035|147284415|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||Comparison at Day 28||||0.32
73870305|NCT02206035|147284415|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Comparison at Day 100||||0.63
73870306|NCT02206035|147284415|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Comparison at Day 180||||0.30
73947247|NCT00524030|147426845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exit rate ≥68%||||0.001
73947248|NCT03315130|147426852|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.7|=|0.0941|TWO_SIDED|80.0|-4.5|-0.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.1|-4.5|=0.0941
73947249|NCT03315130|147426852|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.7|=|0.0538|TWO_SIDED|80.0|-5.1|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-5.1|=0.0538
73947250|NCT03315130|147426853|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.3|=|0.047|TWO_SIDED|80.0|-3.9|-0.5||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.5|-3.9|=0.0470
73947251|NCT03315130|147426853|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.3|=|0.0392|TWO_SIDED|80.0|-4.0|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-4.0|=0.0392
73947252|NCT03315130|147426854|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.4|=|0.017|TWO_SIDED|80.0|-8.4|-2.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-2.1|-8.4|=0.0170
73947253|NCT03315130|147426854|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|2.4|=|0.0624|TWO_SIDED|80.0|-6.9|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-6.9|=0.0624
73947254|NCT03315130|147426855|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.2|=|0.1866|TWO_SIDED|80.0|-4.9|0.9||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||0.9|-4.9|=0.1866
73947255|NCT03315130|147426855|SUPERIORITY||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.2|=|0.0391|TWO_SIDED|80.0|-7.0|-1.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-1.1|-7.0|=0.0391
73947256|NCT03315130|147426859|SUPERIORITY||LS Mean Difference|-82.597|STANDARD_ERROR_OF_MEAN|3.563|<|0.0001|TWO_SIDED|80.0|-87.249|-77.946||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-77.946|-87.249|<0.0001
73947257|NCT03315130|147426859|SUPERIORITY||LS Mean Difference|-95.689|STANDARD_ERROR_OF_MEAN|3.91|<|0.0001|TWO_SIDED|80.0|-100.794|-90.585||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-90.585|-100.794|<0.0001
73947258|NCT03315130|147426860|SUPERIORITY||LS Mean Difference|60.123|STANDARD_ERROR_OF_MEAN|9.394|<|0.0001|TWO_SIDED|80.0|47.839|72.408||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||72.408|47.839|<0.0001
73947259|NCT03315130|147426860|SUPERIORITY||LS Mean Difference|57.076|STANDARD_ERROR_OF_MEAN|9.269|<|0.0001|TWO_SIDED|80.0|44.955|69.197||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||69.197|44.955|<0.0001
73947260|NCT02707692|147426865|SUPERIORITY||Mean Difference (Final Values)|-988.0||||0.32|TWO_SIDED|95.0|-2996.3|1020.3|||Paired t-test, 2 sided|||Primary hypothesis: Participants will have a higher absolute difference in levels of CD4+ T cell-associated HIV RNA transcription seven days after receiving either Pneumococcal or Influenza vaccinations, when compared to seven days after receiving placebo.||1020.3|-2996.3|0.32
73947261|NCT02707692|147426865|SUPERIORITY||Mean Difference (Final Values)|-405.0||||0.31|TWO_SIDED|95.0|-1199.7|389.7|||Paired t-test, 2 sided|||Primary hypothesis: Participants will have a higher absolute difference in levels of CD4+ T cell-associated HIV RNA transcription seven days after receiving either Pneumococcal or Influenza vaccinations, when compared to seven days after receiving placebo.||389.7|-1199.7|0.31
73947262|NCT04867785|147426911|SUPERIORITY||Least Squares (LS) Mean Difference|-0.38||||0.188|TWO_SIDED|95.0|-0.94|0.18|||Mixed Models Analysis|||||0.18|-0.94|0.188
73947263|NCT04867785|147426911|SUPERIORITY||LSMean Difference|-1.34|||<|0.001|TWO_SIDED|95.0|-1.84|-0.85|||Mixed Models Analysis|||||-0.85|-1.84|<0.001
73947264|NCT04867785|147426911|SUPERIORITY||LSMean Difference|-1.25|||<|0.001|TWO_SIDED|95.0|-1.85|-0.65|||Mixed Models Analysis|||||-0.65|-1.85|<0.001
73947265|NCT04867785|147426911|SUPERIORITY||LSMean Difference|-1.94|||<|0.001|TWO_SIDED|95.0|-2.44|-1.43|||Mixed Models Analysis|||||-1.43|-2.44|<0.001
73947266|NCT04867785|147426911|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.42|-1.24|||Mixed Models Analysis|||||-1.24|-2.42|<0.001
73947267|NCT04867785|147426911|SUPERIORITY||LSMean Difference|-1.96|||<|0.001|TWO_SIDED|95.0|-2.43|-1.5|||Mixed Models Analysis|||||-1.50|-2.43|<0.001
73947268|NCT04867785|147426912|SUPERIORITY||LSMean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.52|1.43|||Mixed Models Analysis|||||1.43|0.52|<0.001
73947269|NCT04867785|147426912|SUPERIORITY||LSMean Difference|0.01||||0.935|TWO_SIDED|95.0|-0.34|0.37|||Mixed Models Analysis|||||0.37|-0.34|0.935
73947270|NCT04867785|147426912|SUPERIORITY||LSMean Difference|0.11||||0.668|TWO_SIDED|95.0|-0.39|0.6|||Mixed Models Analysis|||||0.60|-0.39|0.668
73870307|NCT01934010|147284416|SUPERIORITY|||||||0.128|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 2 treatment cycles.||||0.128
73870308|NCT01934010|147284416|SUPERIORITY|||||||0.075|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 3 treatment cycles.||||0.075
73870309|NCT01934010|147284416|SUPERIORITY|||||||1|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 2 treatment cycles with AM-101 or others who received 3 treatment cycles.||||1
73870310|NCT01934010|147284417|SUPERIORITY|||||||0.4403|||||||Fisher Exact|||||||0.4403
73870311|NCT01934010|147284419|SUPERIORITY|||||||0.2401|||||||Fisher Exact|||||||0.2401
73976457|NCT04038580|147498830|SUPERIORITY|Appearance||||||0.032|||||||ANOVA|||||||0.032
73976458|NCT04038580|147498830|SUPERIORITY|Sounds||||||0.352|||||||ANOVA|||||||0.352
73976459|NCT04038580|147498830|SUPERIORITY|Well-being||||||0.077|||||||ANOVA|||||||.077
73976460|NCT04038580|147498831|SUPERIORITY|||||||0.95|||||||ANOVA|general linear model with socket as fixed factor and participant as random factor||||||0.95
73976461|NCT04038580|147498832|SUPERIORITY|||||||0.853|||||||ANOVA|general linear model with sockets as fixed effect and subjects as random effect||||||.853
73976462|NCT04038580|147498833|SUPERIORITY|||||||0.565|||||||ANOVA|general linear model with socket as a fixed factor and subjects as a random factor||||||0.565
73976463|NCT04038580|147498835|SUPERIORITY|||||||0.374|||||||ANOVA|general linear model with socket as fixed factor and subjects as random factor||||||.374
73976464|NCT04038580|147498837|SUPERIORITY|||||||0.574|||||||ANOVA|general linear model with socket as a fixed factor and subjects as a random factor||||||.574
73976465|NCT05080777|147498884|EQUIVALENCE|Group, Time, and Group x Time effect tests were performed using MLM.||||||0.295||||||.P-value shown is based on the Group x Time F statistic used in multilevel modeling (MLM)|Multilevel modeling (MLM)|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.295
73976466|NCT05080777|147498885|EQUIVALENCE|Group, time, and group x time effect tests were performed using multilevel modeling (MLM).||||||0.57||||||P-value shown is based on the group x time F statistic used in MLM.|MLM|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.570
73976467|NCT05080777|147498886|EQUIVALENCE|Group, time, and time x group effect tests were performed using multilevel modeling (MLM).||||||0.461||||||P-value shown is based on the group x time F statistic used in MLM.|MLM|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.461
73976468|NCT05256797|147498889|SUPERIORITY||Cox Proportional Hazard|0.69|||||TWO_SIDED|95.0|0.66|0.71||||||Hazard ratio||0.71|0.66|
73976469|NCT01274338|147498915|SUPERIORITY|||||||0.065||||||This design provides at least 80% power at a one sided type I error rate of 0.003.|Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.065
73976470|NCT01274338|147498916|SUPERIORITY|This design will provide 80% power to detect the difference between the two arms at a one-sided type I error rate of 0.022.||||||0.044|||||||Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.044
73976471|NCT01274338|147498918|SUPERIORITY|||||||0.289||||||If low dose Ipi (LIP) vs. HDI is significant for OS at the 2.2% level, then we will compare high dose Ipi (HIP) vs. HDI at the 2.2% level.|Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.289
73976472|NCT06072170|147498926|OTHER|Proportionality analysis was done using a power model.|Slope|0.829|||||TWO_SIDED|90.0|0.659|0.998||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.998|0.659|
73976473|NCT06072170|147498926|OTHER|Proportionality analysis was done using a power model.|Slope|0.843|||||TWO_SIDED|90.0|0.713|0.973||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.973|0.713|
73976474|NCT06072170|147498926|OTHER|Proportionality analysis was done using a power model.|Slope|0.811|||||TWO_SIDED|90.0|0.637|0.984||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.984|0.637|
73976475|NCT06072170|147498926|OTHER|Proportionality analysis was done using a power model.|Slope|0.814|||||TWO_SIDED|90.0|0.633|0.994||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.994|0.633|
73976476|NCT06072170|147498926|OTHER|Proportionality analysis was done using a power model.|Slope|0.88|||||TWO_SIDED|90.0|0.72|1.039||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.039|0.720|
73976477|NCT06072170|147498928|OTHER|Proportionality analysis was done using a power model.|Slope|0.946|||||TWO_SIDED|90.0|0.768|1.123||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.123|0.768|
74032073|NCT02749721|147617308|OTHER||Pearson's R|0.052||||0.832|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 (latency) baseline scores||||0.832
73947271|NCT04867785|147426912|SUPERIORITY||LSMean Difference|-0.58||||0.002|TWO_SIDED|95.0|-0.95|-0.21|||Mixed Models Analysis|||||-0.21|-0.95|0.002
73947272|NCT04867785|147426912|SUPERIORITY||LSMean Difference|-0.47||||0.056|TWO_SIDED|95.0|-0.95|0.01|||Mixed Models Analysis|||||0.01|-0.95|0.056
73947273|NCT04867785|147426912|SUPERIORITY||LSMean Difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.93|-0.29|||Mixed Models Analysis|||||-0.29|-0.93|<0.001
73976478|NCT06072170|147498928|OTHER|Proportionality analysis was done using a power model.|Slope|0.978|||||TWO_SIDED|90.0|0.821|1.134||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.134|0.821|
73976479|NCT06072170|147498928|OTHER|Proportionality analysis was done using a power model.|Slope|1.075|||||TWO_SIDED|90.0|0.901|1.249||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.249|0.901|
73976480|NCT06072170|147498928|OTHER|Proportionality analysis was done using a power model.|Slope|1.046|||||TWO_SIDED|90.0|0.87|1.222||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.222|0.870|
73976481|NCT06072170|147498928|OTHER|Proportionality analysis was done using a power model.|Slope|1.011|||||TWO_SIDED|90.0|0.844|1.178||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.178|0.844|
73976482|NCT06072170|147498929|OTHER|Proportionality analysis was done using a power model.|Slope|0.959|||||TWO_SIDED|90.0|0.775|1.143||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.143|0.775|
74009115|NCT02367066|147568883|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|80.0|0.96|1.03||1-sided|Mixed Models Analysis|||||1.03|0.96|0.41
74009116|NCT02367066|147568884|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.05||0.06|TWO_SIDED|80.0|0.85|0.99||1-sided|Mixed Models Analysis|||||0.99|0.85|0.06
74009117|NCT02367066|147568885|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.04||0.18|TWO_SIDED|80.0|0.99|1.13||1-sided|Mixed Models Analysis|||||1.13|0.99|0.18
74009118|NCT02367066|147568886|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.04||0.04|TWO_SIDED|80.0|0.89|0.98||1-sided|Mixed Models Analysis|||||0.98|0.89|0.04
73947274|NCT04867785|147426913|SUPERIORITY||LSMean Difference|-0.24||||0.448|TWO_SIDED|95.0|-0.85|0.38|||Mixed Models Analysis|||||0.38|-0.85|0.448
73947275|NCT04867785|147426913|SUPERIORITY||LSMean Difference|-0.99||||0.001|TWO_SIDED|95.0|-1.6|-0.38|||Mixed Models Analysis|||||-0.38|-1.60|0.001
73947276|NCT04867785|147426913|SUPERIORITY||LSMean Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.8|-0.59|||Mixed Models Analysis|||||-0.59|-1.80|<0.001
73947277|NCT04867785|147426913|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.41|-1.24|||Mixed Models Analysis|||||-1.24|-2.41|<0.001
73947278|NCT04867785|147426913|SUPERIORITY||LSMean Difference|-1.63|||<|0.001|TWO_SIDED|95.0|-2.27|-0.99|||Mixed Models Analysis|||||-0.99|-2.27|<0.001
73947279|NCT04867785|147426913|SUPERIORITY||LSMean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.39|-1.31|||Mixed Models Analysis|||||-1.31|-2.39|<0.001
74009119|NCT02367066|147568888|SUPERIORITY_OR_OTHER||Geometric LS MEan Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED|80.0|0.91|1.06||1-sided|Mixed Models Analysis|||||1.06|0.91|0.37
74009120|NCT02367066|147568890|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.01||0.06|TWO_SIDED|80.0|1.0|1.04||1-sided|Mixed Models Analysis|||||1.04|1.00|0.06
74009121|NCT02367066|147568891|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.45|TWO_SIDED|90.0|-0.01|0.03||2-sided|Mixed Models Analysis|||||0.03|-0.01|0.45
74009122|NCT01898689|147568908|EQUIVALENCE|The a priori equivalence region for the difference in means between the two concentrations was specified as +10 mA. This value was considered the minimal clinically relevant current since it approximates the tolerated electrical current range at baseline of the general population-in other words, natural variability and therefore a relatively small amount of current to detect.|Mean Difference (Net)|0.2||||0.02|TWO_SIDED|90.0|-8.2|8.5||"P-values from the TOST procedure were 0.02 and 0.03 for the mean being inside the lower and upper boundaries, respectively.~(estimated mean difference of 0.2 mA; 90% CI 28.2 to 8.5)"|Mixed Models Analysis|||"The null and alternative hypotheses were thus:~H0: m0.1%-m0.4% ≤ -10 or m0.1%-m0.4% ≥ 10 and Ha: -10 , m0.1%-m0.4% , 10 where m0.1% and m0.1% are the population means for tolerance to current under 0.1% and 0.4% ropivacaine, respectively.~With 24 evaluable subjects, we had 90% power at the 0.05 significance level to detect equivalence of 0.1% and 0.4% ropivacaine concentration on the mean tolerance to transcutaneous electrical stimulation"||8.5|-8.2|0.02
74009123|NCT04556136|147568916|NON_INFERIORITY|This non-inferiority study was designed to demonstrate the ability of the phototherapy kiosk to safely administer UVB radiation to participants with varying levels of 25(OH)D and achieve comparable levels of serum 25(OH)D in a similar population of adults randomized to receive RDA of 600 IU vitamin D oral supplementation daily. It is important to evaluate device equivalence to standard of care in the maintenance of sufficient levels of vitamin D in adults 18 - 70 years old.||||||0.01||||||Threshold for significance \<0.05|Wilcoxon (Mann-Whitney)|Effect sizes for significant differences were included as eta squared (ŋ2) values.||The intent-to-treat analysis plan was carried out with all available subject data points. No interim analysis was performed. Exploratory data analyses were conducted on serum vitamin D levels of participants assigned to either the oral supplementation or kiosk group. Analysis was restricted to participants with valid baseline serum vitamin D data and at least one follow-up blood draw. The Shapiro-Wilk test was used to assess the normality of the data distribution.||||0.01
74009124|NCT00953719|147568931|NON_INFERIORITY_OR_EQUIVALENCE|The prospectively planned primary endpoint analysis was a non-inferiority test of covariate adjusted 24 month or later Harris Hip score means with a 5 point non-inferiority margin. A prospective power analysis with an anticipated Harris Hip score standard deviation of 10.08 (for both treatment groups) indicated that sample sizes of 134 and 67 would provide approximately 95% statistical power for this non-inferiority test with a type 1 error rate of 5%.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|ONE_SIDED|95.0|-1.4||||ANCOVA||||||-1.40|<0.001
74009125|NCT00953719|147568937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.079||||0.952||95.0|||||Mixed Models Analysis|SAS PROC MIXED was used with an ante-dependence covariance structure.||A repeated measurements longitudinal model of Harris Hip scores was carried out to compare Harris Hip results between treatment groups across time.||||0.952
73947280|NCT04867785|147426913|SUPERIORITY||LSMean Difference|0.82|||<|0.001|TWO_SIDED|95.0|0.35|1.29|||Mixed Models Analysis|||||1.29|0.35|<0.001
73947281|NCT04867785|147426913|SUPERIORITY||LSMean Difference|0.06||||0.796|TWO_SIDED|95.0|-0.41|0.53|||Mixed Models Analysis|||||0.53|-0.41|0.796
73947282|NCT04867785|147426913|SUPERIORITY||LSMean Difference|-0.14||||0.548|TWO_SIDED|95.0|-0.61|0.32|||Mixed Models Analysis|||||0.32|-0.61|0.548
73947283|NCT04867785|147426913|SUPERIORITY||LSMean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.19|-0.36|||Mixed Models Analysis|||||-0.36|-1.19|<0.001
73947284|NCT04867785|147426913|SUPERIORITY||LSMean Difference|-0.57||||0.025|TWO_SIDED|95.0|-1.08|-0.07|||Mixed Models Analysis|||||-0.07|-1.08|0.025
73947285|NCT04867785|147426913|SUPERIORITY||LSMean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.16|-0.44|||Mixed Models Analysis|||||-0.44|-1.16|<0.001
73947286|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|0.14||||0.121|TWO_SIDED|95.0|-0.04|0.32|||Regression, Logistic|||||0.32|-0.04|0.121
73947287|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|0.36||||0.002|TWO_SIDED|95.0|0.13|0.59|||Regression, Logistic|||||0.59|0.13|0.002
73947288|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|0.48|||<|0.001|TWO_SIDED|95.0|0.28|0.68|||Regression, Logistic|||||0.68|0.28|<0.001
73947289|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|0.7|||<|0.001|TWO_SIDED|95.0|0.53|0.87|||Regression, Logistic|||||0.87|0.53|<0.001
73947290|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|0.6|||<|0.001|TWO_SIDED|95.0|0.39|0.82|||Regression, Logistic|||||0.82|0.39|<0.001
73947291|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|0.68|||<|0.001|TWO_SIDED|95.0|0.51|0.85|||Regression, Logistic|||||0.85|0.51|<0.001
73947292|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|-0.21||||0.03|TWO_SIDED|95.0|-0.39|-0.02|||Regression, Logistic|||||-0.02|-0.39|0.030
73976483|NCT06072170|147498929|OTHER|Proportionality analysis was done using a power model.|Slope|0.974|||||TWO_SIDED|90.0|0.815|1.134||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.134|0.815|
73947293|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|0.01||||0.938|TWO_SIDED|95.0|-0.22|0.24|||Regression, Logistic|||||0.24|-0.22|0.938
73947294|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|0.13||||0.209|TWO_SIDED|95.0|-0.07|0.33|||Regression, Logistic|||||0.33|-0.07|0.209
73976484|NCT06072170|147498929|OTHER|Proportionality analysis was done using a power model.|Slope|1.036|||||TWO_SIDED|90.0|0.866|1.207||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.207|0.866|
73976485|NCT06072170|147498929|OTHER|Proportionality analysis was done using a power model.|Slope|0.967|||||TWO_SIDED|90.0|0.79|1.145||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.145|0.790|
73976486|NCT06072170|147498929|OTHER|Proportionality analysis was done using a power model.|Slope|1.025|||||TWO_SIDED|90.0|0.859|1.191||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.191|0.859|
73976487|NCT06072170|147498933|SUPERIORITY||Least-Square Mean|18.5|STANDARD_ERROR_OF_MEAN|6.06|||TWO_SIDED|95.0|6.16|30.78||||||||30.78|6.16|
73947295|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|0.35|||<|0.001|TWO_SIDED|95.0|0.18|0.53|||Regression, Logistic|||||0.53|0.18|<0.001
73947296|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|0.26||||0.024|TWO_SIDED|95.0|0.03|0.48|||Regression, Logistic|||||0.48|0.03|0.024
73947297|NCT04867785|147426914|SUPERIORITY||Risk Difference (RD)|0.33|||<|0.001|TWO_SIDED|95.0|0.16|0.51|||Regression, Logistic|||||0.51|0.16|<0.001
73947298|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|0.14||||0.169|TWO_SIDED|95.0|-0.06|0.35|||Regression, Logistic|||||0.35|-0.06|0.169
73947299|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|0.39||||0.001|TWO_SIDED|95.0|0.15|0.63|||Regression, Logistic|||||0.63|0.15|0.001
73947300|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|0.37||||0.002|TWO_SIDED|95.0|0.14|0.6|||Regression, Logistic|||||0.60|0.14|0.002
73947301|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|0.59|||<|0.001|TWO_SIDED|95.0|0.39|0.79|||Regression, Logistic|||||0.79|0.39|<0.001
73947302|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|0.56|||<|0.001|TWO_SIDED|95.0|0.34|0.78|||Regression, Logistic|||||0.78|0.34|<0.001
73947303|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|0.57|||<|0.001|TWO_SIDED|95.0|0.38|0.76|||Regression, Logistic|||||0.76|0.38|<0.001
73947304|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|-0.23||||0.029|TWO_SIDED|95.0|-0.44|-0.02|||Regression, Logistic|||||-0.02|-0.44|0.029
73947305|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|0.02||||0.898|TWO_SIDED|95.0|-0.22|0.25|||Regression, Logistic|||||0.25|-0.22|0.898
73947306|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|0.0||||0.968|TWO_SIDED|95.0|-0.24|0.23|||Regression, Logistic|||||0.23|-0.24|0.968
73947307|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|0.22||||0.033|TWO_SIDED|95.0|0.02|0.42|||Regression, Logistic|||||0.42|0.02|0.033
73947308|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|0.19||||0.099|TWO_SIDED|95.0|-0.04|0.41|||Regression, Logistic|||||0.41|-0.04|0.099
73947309|NCT04867785|147426915|SUPERIORITY||Risk Difference (RD)|0.2||||0.044|TWO_SIDED|95.0|0.01|0.39|||Regression, Logistic|||||0.39|0.01|0.044
73947310|NCT04867785|147426916|SUPERIORITY||LSMean Difference|-2.12||||0.823|TWO_SIDED|95.0|-20.73|16.48|||Mixed Models Analysis|||||16.48|-20.73|0.823
73947311|NCT04867785|147426916|SUPERIORITY||LSMean Difference|-19.6||||0.165|TWO_SIDED|95.0|-47.29|8.1|||Mixed Models Analysis|||||8.10|-47.29|0.165
73947312|NCT04867785|147426916|SUPERIORITY||LSMean Difference|-33.3||||0.001|TWO_SIDED|95.0|-53.56|-13.04|||Mixed Models Analysis|||||-13.04|-53.56|0.001
73947313|NCT04867785|147426916|SUPERIORITY||LSMean Difference|-55.5|||<|0.001|TWO_SIDED|95.0|-69.77|-41.22|||Mixed Models Analysis|||||-41.22|-69.77|<0.001
73947314|NCT04867785|147426916|SUPERIORITY||LSMean Difference|-29.22||||0.015|TWO_SIDED|95.0|-52.84|-5.59|||Mixed Models Analysis|||||-5.59|-52.84|0.015
73947315|NCT04867785|147426916|SUPERIORITY||LSMean Difference|-54.61|||<|0.001|TWO_SIDED|95.0|-69.63|-39.59|||Mixed Models Analysis|||||-39.59|-69.63|<0.001
73947316|NCT04867785|147426916|SUPERIORITY||LSMean Difference|33.54|||<|0.001|TWO_SIDED|95.0|18.26|48.82|||Mixed Models Analysis|||||48.82|18.26|<0.001
73947317|NCT04867785|147426916|SUPERIORITY||LSMean Difference|16.07||||0.231|TWO_SIDED|95.0|-10.25|42.39|||Mixed Models Analysis|||||42.39|-10.25|0.231
73947318|NCT04867785|147426916|SUPERIORITY||LSMean Difference|2.37||||0.804|TWO_SIDED|95.0|-16.28|21.01|||Mixed Models Analysis|||||21.01|-16.28|0.804
73870312|NCT01934010|147284419|SUPERIORITY|||||||0.0022|||||||Fisher Exact|||||||0.0022
73976488|NCT06072170|147498936|SUPERIORITY||Least-Squared Mean|45.9|STANDARD_ERROR_OF_MEAN|7.74|<|0.001|TWO_SIDED|95.0|30.2|61.67|||ANOVA|||Statistical Analysis for High Visual Analog Scale (Emax)||61.67|30.20|<0.001
73976489|NCT03678688|147498937|SUPERIORITY||EBA Ratio|0.689|||||TWO_SIDED|95.0|0.485|0.939|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.939|0.485|
73976490|NCT03678688|147498937|SUPERIORITY||EBA Ratio|0.689|||||TWO_SIDED|95.0|0.467|0.911|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.911|0.467|
73870313|NCT01934010|147284419|SUPERIORITY|||||||0.1001|||||||Fisher Exact|||||||0.1001
73976491|NCT03678688|147498937|SUPERIORITY||EBA Ratio|0.759|||||TWO_SIDED|95.0|0.517|1.051|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||1.051|0.517|
73976492|NCT03678688|147498937|SUPERIORITY||EBA Ratio|0.759|||||TWO_SIDED|95.0|0.497|1.02|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||1.020|0.497|
73976493|NCT03678688|147498937|SUPERIORITY||EBA Ratio|0.745|||||TWO_SIDED|95.0|0.567|0.973|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.973|0.567|
73976494|NCT03678688|147498937|SUPERIORITY||EBA Ratio|0.745|||||TWO_SIDED|95.0|0.547|0.943|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.943|0.547|
73976495|NCT03678688|147498937|SUPERIORITY||EBA Ratio|0.605|||||TWO_SIDED|95.0|0.353|0.896|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.896|0.353|
73976496|NCT03678688|147498937|SUPERIORITY||EBA Ratio|0.605|||||TWO_SIDED|95.0|0.338|0.871|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.871|0.338|
73976497|NCT03678688|147498977|SUPERIORITY||EBA Ratio|1.256|||||TWO_SIDED|95.0|0.626|3.175|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||3.175|0.626|
73976498|NCT03678688|147498977|SUPERIORITY||EBA Ratio|1.256|||||TWO_SIDED|95.0|0.362|2.151|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||2.151|0.362|
73976499|NCT03678688|147498977|SUPERIORITY||EBA Ratio|1.385|||||TWO_SIDED|95.0|0.736|2.656|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||2.656|0.736|
73976500|NCT03678688|147498977|SUPERIORITY||EBA Ratio|1.385|||||TWO_SIDED|95.0|0.564|2.206|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||2.206|0.564|
73976501|NCT02949297|147499000|OTHER|One-sided Clopper-Pearson 95% confidence interval|Clopper-Pearson|80.0|||||ONE_SIDED|95.0||95.0|||||One-sided Clopper-Pearson 95% confidence interval|||95||
73976502|NCT00458783|147499015|SUPERIORITY||Odds Ratio (OR)|0.77||||0.08|TWO_SIDED|95.0|0.5|1.2|||generalized estimating equation (GEE)|Generalized estimating equation (GEE) distinct-effects model||||1.2|0.50|0.08
74032074|NCT02749721|147617308|OTHER||Pearson's R|0.103||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a (latency) baseline scores||||0.68
73870314|NCT01934010|147284420|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73870315|NCT04929249|147284427|SUPERIORITY||LS mean difference|-53.0|||<|0.001|TWO_SIDED|97.5|-60.0|-46.0|||Mixed Models Analysis|||||-46.0|-60.0|<0.001
73870316|NCT04929249|147284428|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the one-sided 98.75% confidence interval did not exceed the non-inferiority margin of 15%.|Difference in percentage|-10.6|||||TWO_SIDED|97.5|-18.3|-3.0|||Normal approx. to binomial distribution||||Upper limit of one-sided 98.75% CI (-3.0%)|-3.0|-18.3|
73870317|NCT04929249|147284429|SUPERIORITY||LS mean difference|-47.6|||<|0.001|TWO_SIDED|95.0|-52.8|-42.3|||Mixed Models Analysis|||||-42.3|-52.8|<0.001
73870318|NCT04929249|147284430|SUPERIORITY||LS mean difference|-54.4|||<|0.001|TWO_SIDED|95.0|-59.0|-49.8|||Regression, Linear|||||-49.8|-59.0|<0.001
73870319|NCT04929249|147284431|SUPERIORITY||LS mean difference|-48.9|||<|0.001|TWO_SIDED|95.0|-52.9|-44.9|||Regression, Linear|||||-44.9|-52.9|<0.001
73870320|NCT04929249|147284432|SUPERIORITY||Odds Ratio (OR)|42.32|||<|0.001|TWO_SIDED|95.0|22.07|81.16|||Regression, Logistic|||||81.16|22.07|<0.001
73870321|NCT04929249|147284433|SUPERIORITY||Odds Ratio (OR)|17.32|||<|0.001|TWO_SIDED|95.0|6.72|44.66|||Regression, Logistic|||||44.66|6.72|<0.001
73870322|NCT04929249|147284434|SUPERIORITY||Odds Ratio (OR)|24.46|||<|0.001|TWO_SIDED|95.0|14.18|42.19|||Regression, Logistic|||||42.19|14.18|<0.001
73870323|NCT04929249|147284435|SUPERIORITY||Odds Ratio (OR)|35.12|||<|0.001|TWO_SIDED|95.0|19.51|63.24|||Regression, Logistic|||||63.24|19.51|<0.001
73976503|NCT00458783|147499016|SUPERIORITY||Odds Ratio, log|0.64|||||TWO_SIDED|95.0|0.25|1.6||||||||1.6|0.25|
73976504|NCT00458783|147499017|SUPERIORITY||Odds Ratio, log|0.72|||||TWO_SIDED|95.0|0.26|2.0||||||||2.0|0.26|
73976505|NCT00458783|147499018|SUPERIORITY||Odds Ratio, log|0.9|||||TWO_SIDED|95.0|0.59|1.4||||||||1.4|0.59|
73976506|NCT00458783|147499019|SUPERIORITY||Odds Ratio, log|0.86|||||TWO_SIDED|95.0|0.43|1.8||||||||1.8|0.43|
73976507|NCT00458783|147499020|SUPERIORITY||Risk Ratio, log|0.81|||||TWO_SIDED|95.0|0.24|2.8||||||||2.8|0.24|
73976508|NCT00458783|147499021|SUPERIORITY||Odds Ratio, log|1.1|||||TWO_SIDED|95.0|0.8|1.5||||||||1.5|0.80|
73976509|NCT00458783|147499022|SUPERIORITY||Odds Ratio, log|0.43|||||TWO_SIDED|95.0|0.16|1.1||||||||1.1|0.16|
73976510|NCT00458783|147499023|SUPERIORITY||Odds Ratio, log|0.82|||||TWO_SIDED|95.0|0.39|1.7||||||||1.7|0.39|
73976511|NCT00458783|147499024|SUPERIORITY||Odds Ratio, log|0.82|||||TWO_SIDED|95.0|0.5|1.3||||||||1.3|0.50|
73976512|NCT00458783|147499025|SUPERIORITY||Odds Ratio, log|0.76|||||TWO_SIDED|95.0|0.18|3.2||||||||3.2|0.18|
73976513|NCT00458783|147499026|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.9|TWO_SIDED|95.0|0.94|1.29|||Regression, Cox||The 95%CI is interim adjusted.|||1.29|0.94|0.9
73976514|NCT00458783|147499027|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.07|TWO_SIDED|95.0|0.85|1.18|||Regression, Cox||The 95%CI is interim adjusted.|||1.18|0.85|0.07
73976515|NCT06307457|147499030|OTHER|||||||0.031|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all age groups.||||0.031
73976516|NCT06307457|147499031|OTHER|||||||0.012|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all age groups.||||0.012
73976517|NCT06307457|147499032|OTHER|||||||0.061|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all CCI scores.||||0.061
74032075|NCT02749721|147617308|OTHER||Pearson's R|-0.074||||0.777|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 (Latency) baseline to endpoint percentage change||||0.777
73870324|NCT04929249|147284436|SUPERIORITY||LS mean difference|-30.1|||<|0.001|TWO_SIDED|95.0|-33.8|-26.3|||Mixed Models Analysis|||Total Cholesterol||-26.3|-33.8|<0.001
73870325|NCT04929249|147284436|SUPERIORITY||LS mean difference|6.6|||<|0.001|TWO_SIDED|95.0|3.6|9.5|||Mixed Models Analysis|||HDL Cholesterol||9.5|3.6|<0.001
73870326|NCT04929249|147284436|SUPERIORITY||LS mean difference|-44.2|||<|0.001|TWO_SIDED|95.0|-49.1|-39.3|||Mixed Models Analysis|||Non-HDL Cholesterol||-39.3|-49.1|<0.001
73947319|NCT04867785|147426916|SUPERIORITY||LSMean Difference|-19.83|||<|0.001|TWO_SIDED|95.0|-31.01|-8.65|||Mixed Models Analysis|||||-8.65|-31.01|<0.001
73947320|NCT04867785|147426916|SUPERIORITY||LSMean Difference|6.45||||0.586|TWO_SIDED|95.0|-16.75|29.65|||Mixed Models Analysis|||||29.65|-16.75|0.586
73947321|NCT04867785|147426916|SUPERIORITY||LSMean Difference|-18.94||||0.002|TWO_SIDED|95.0|-30.93|-6.96|||Mixed Models Analysis|||||-6.96|-30.93|0.002
73947322|NCT04867785|147426917|SUPERIORITY||LSMean Difference|-0.25||||0.984|TWO_SIDED|95.0|-24.57|24.07|||Mixed Models Analysis|||||24.07|-24.57|0.984
73947323|NCT04867785|147426917|SUPERIORITY||LSMean Difference|-4.2||||0.804|TWO_SIDED|95.0|-37.44|29.03|||Mixed Models Analysis|||||29.03|-37.44|0.804
73947324|NCT04867785|147426917|SUPERIORITY||LSMean Difference|-21.47||||0.167|TWO_SIDED|95.0|-51.91|8.98|||Mixed Models Analysis|||||8.98|-51.91|0.167
73947325|NCT04867785|147426917|SUPERIORITY||LSMean Difference|-51.84|||<|0.001|TWO_SIDED|95.0|-76.09|-27.59|||Mixed Models Analysis|||||-27.59|-76.09|<0.001
73976518|NCT06307457|147499033|OTHER|||||||0.08|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all CCI scores.||||0.080
73870327|NCT04929249|147284436|SUPERIORITY||LS mean difference|-16.9|||<|0.001|TWO_SIDED|95.0|-23.8|-10.0|||Mixed Models Analysis|||VLDL Cholesterol||-10.0|-23.8|<0.001
73870328|NCT04929249|147284436|SUPERIORITY||LS mean difference|-17.8|||<|0.001|TWO_SIDED|95.0|-24.7|-10.9|||Mixed Models Analysis|||Triglycerides||-10.9|-24.7|<0.001
73870329|NCT04929249|147284436|SUPERIORITY||LS mean difference|-42.6|||<|0.001|TWO_SIDED|95.0|-47.5|-37.8|||Mixed Models Analysis|||Apolipoprotein B||-37.8|-47.5|<0.001
73870330|NCT04929249|147284436|SUPERIORITY||LS mean difference|-21.9|||<|0.001|TWO_SIDED|95.0|-25.8|-18.0|||Mixed Models Analysis|||Lipoprotein(a)||-18.0|-25.8|<0.001
73870331|NCT04929249|147284437|SUPERIORITY||LS mean difference|-49.9|||<|0.001|TWO_SIDED|95.0|-56.0|-43.9|||Mixed Models Analysis|||Total Cholesterol||-43.9|-56.0|<0.001
73870332|NCT04929249|147284437|SUPERIORITY||LS mean difference|3.1|||<|0.001|TWO_SIDED|95.0|1.8|4.4|||Mixed Models Analysis|||HDL Cholesterol||4.4|1.8|<0.001
73870333|NCT04929249|147284437|SUPERIORITY||LS mean difference|-52.4|||<|0.001|TWO_SIDED|95.0|-58.1|-46.7|||Mixed Models Analysis|||Non-HDL Cholesterol||-46.7|-58.1|<0.001
73870334|NCT04929249|147284437|SUPERIORITY||LS mean difference|-4.6|||<|0.001|TWO_SIDED|95.0|-6.5|-2.8|||Mixed Models Analysis|||VLDL Cholesterol||-2.8|-6.5|<0.001
73870335|NCT04929249|147284437|SUPERIORITY||LS mean difference|-25.3|||<|0.001|TWO_SIDED|95.0|-34.8|-15.8|||Mixed Models Analysis|||Triglycerides||-15.8|-34.8|<0.001
73870336|NCT04929249|147284437|SUPERIORITY||LS mean difference|-36.3|||<|0.001|TWO_SIDED|95.0|-39.7|-32.9|||Mixed Models Analysis|||Apolipoprotein B||-32.9|-39.7|<0.001
73870337|NCT04929249|147284437|SUPERIORITY||LS mean difference|-8.7|||<|0.001|TWO_SIDED|95.0|-10.7|-6.8|||Mixed Models Analysis|||Lipoprotein(a)||-6.8|-10.7|<0.001
73870338|NCT04929249|147284438|SUPERIORITY||Odds Ratio (OR)|1.06||||0.899|TWO_SIDED|95.0|0.43|2.61|||proportional odds model|||||2.61|0.43|0.899
73870339|NCT04929249|147284439|SUPERIORITY||LS mean difference|-0.008||||0.727|TWO_SIDED|95.0|-0.055|0.039|||Regression, Linear|||||0.039|-0.055|0.727
73947326|NCT04867785|147426917|SUPERIORITY||LSMean Difference|-23.94||||0.168|TWO_SIDED|95.0|-57.94|10.06|||Mixed Models Analysis|||||10.06|-57.94|0.168
73947327|NCT04867785|147426917|SUPERIORITY||LSMean Difference|-50.58|||<|0.001|TWO_SIDED|95.0|-74.94|-26.22|||Mixed Models Analysis|||||-26.22|-74.94|<0.001
73947328|NCT04867785|147426917|SUPERIORITY||LSMean Difference|10.02||||0.362|TWO_SIDED|95.0|-11.55|31.6|||Mixed Models Analysis|||||31.60|-11.55|0.362
73947329|NCT04867785|147426917|SUPERIORITY||LSMean Difference|6.07||||0.696|TWO_SIDED|95.0|-24.34|36.48|||Mixed Models Analysis|||||36.48|-24.34|0.696
73947330|NCT04867785|147426917|SUPERIORITY||LSMean Difference|-11.19||||0.436|TWO_SIDED|95.0|-39.38|16.99|||Mixed Models Analysis|||||16.99|-39.38|0.436
73947331|NCT04867785|147426917|SUPERIORITY||LSMean Difference|-41.57|||<|0.001|TWO_SIDED|95.0|-62.89|-20.25|||Mixed Models Analysis|||||-20.25|-62.89|<0.001
73947332|NCT04867785|147426917|SUPERIORITY||LSMean Difference|-13.67||||0.418|TWO_SIDED|95.0|-46.75|19.42|||Mixed Models Analysis|||||19.42|-46.75|0.418
73947333|NCT04867785|147426917|SUPERIORITY||LSMean Difference|-40.31|||<|0.001|TWO_SIDED|95.0|-60.77|-19.85|||Mixed Models Analysis|||||-19.85|-60.77|<0.001
73947334|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-0.49||||0.54|TWO_SIDED|95.0|-2.07|1.08|||Mixed Models Analysis|||||1.08|-2.07|0.540
73947335|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-4.41|||<|0.001|TWO_SIDED|95.0|-6.69|-2.13|||Mixed Models Analysis|||||-2.13|-6.69|<0.001
73947336|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-6.78|||<|0.001|TWO_SIDED|95.0|-9.47|-4.09|||Mixed Models Analysis|||||-4.09|-9.47|<0.001
73947337|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-10.13|||<|0.001|TWO_SIDED|95.0|-12.24|-8.03|||Mixed Models Analysis|||||-8.03|-12.24|<0.001
73947338|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-12.06|||<|0.001|TWO_SIDED|95.0|-15.06|-9.06|||Mixed Models Analysis|||||-9.06|-15.06|<0.001
73947339|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-10.99|||<|0.001|TWO_SIDED|95.0|-13.24|-8.73|||Mixed Models Analysis|||||-8.73|-13.24|<0.001
73947340|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-1.19||||0.135|TWO_SIDED|95.0|-2.75|0.37|||Mixed Models Analysis|||||0.37|-2.75|0.135
73947341|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-5.11|||<|0.001|TWO_SIDED|95.0|-7.36|-2.86|||Mixed Models Analysis|||||-2.86|-7.36|<0.001
73976519|NCT06307457|147499034|OTHER|||||||0.2|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all number of comorbidities.||||0.2
73976520|NCT06307457|147499035|OTHER|||||||0.093|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all number of comorbidities.||||0.093
73976521|NCT06307457|147499036|OTHER||||||>|0.9|||||||Log Rank|||Statistical data for participants with cardiac disease comorbidity reported.||||>0.9
73976522|NCT06307457|147499036|OTHER|||||||0.9|||||||Log Rank|||Statistical data for participants with vascular disease comorbidity reported.||||0.9
73976523|NCT06307457|147499036|OTHER|||||||0.4|||||||Log Rank|||Statistical data for participants with metabolic disease comorbidity reported.||||0.4
73870340|NCT02211456|147284448|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.05|TWO_SIDED|95.0|1.0|6.3|||Mixed Models Analysis|||The data derived from this study was complex multi-level data with errors due to patient-level and intra-patient repeat factors. Accordingly, we used generalized multi-level modelling (GLMM) with random effects.||6.3|1|<0.05
73947342|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-7.48|||<|0.001|TWO_SIDED|95.0|-10.19|-4.77|||Mixed Models Analysis|||||-4.77|-10.19|<0.001
73947343|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-10.83|||<|0.001|TWO_SIDED|95.0|-12.89|-8.77|||Mixed Models Analysis|||||-8.77|-12.89|<0.001
73976524|NCT06307457|147499037|OTHER|||||||0.7|||||||Log Rank|||Statistical data for participants cardiac disease comorbidity reported.||||0.7
73976525|NCT06307457|147499037|OTHER|||||||0.3|||||||Log Rank|||Statistical data for participants with vascular disease comorbidity reported.||||0.3
74032076|NCT02749721|147617308|OTHER||Pearson's R|0.061||||0.834|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3a (Latency) baseline to endpoint percentage change||||0.834
73870341|NCT00483938|147284479|SUPERIORITY_OR_OTHER|||||||0.51|||||||Fisher Exact|||SVR: Group A versus Group B||||0.510
73947344|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-12.76|||<|0.001|TWO_SIDED|95.0|-15.74|-9.77|||Mixed Models Analysis|||||-9.77|-15.74|<0.001
73947345|NCT04867785|147426918|SUPERIORITY||LSMean Difference|-11.69|||<|0.001|TWO_SIDED|95.0|-13.9|-9.47|||Mixed Models Analysis|||||-9.47|-13.90|<0.001
73947346|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-0.03||||0.979|TWO_SIDED|95.0|-2.18|2.12|||Mixed Models Analysis|||||2.12|-2.18|0.979
73947347|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-4.0||||0.018|TWO_SIDED|95.0|-7.32|-0.68|||Mixed Models Analysis|||||-0.68|-7.32|0.018
73947348|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-7.09|||<|0.001|TWO_SIDED|95.0|-10.46|-3.71|||Mixed Models Analysis|||||-3.71|-10.46|<0.001
73947349|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-13.2|||<|0.001|TWO_SIDED|95.0|-16.74|-9.66|||Mixed Models Analysis|||||-9.66|-16.74|<0.001
73947350|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-12.84|||<|0.001|TWO_SIDED|95.0|-16.5|-9.18|||Mixed Models Analysis|||||-9.18|-16.50|<0.001
73947351|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-13.91|||<|0.001|TWO_SIDED|95.0|-17.1|-10.71|||Mixed Models Analysis|||||-10.71|-17.10|<0.001
73947352|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-1.34||||0.213|TWO_SIDED|95.0|-3.45|0.77|||Mixed Models Analysis|||||0.77|-3.45|0.213
73870342|NCT00483938|147284480|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||SVR: Group C versus Group D||||1.000
73870343|NCT00483938|147284480|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||SVR: Group E versus Group F||||1.000
73870344|NCT00483938|147284481|SUPERIORITY_OR_OTHER|||||||0.792|||||||Fisher Exact|||ETR: Group A versus Group B||||0.792
73870345|NCT00483938|147284481|SUPERIORITY_OR_OTHER|||||||0.612|||||||Fisher Exact|||ETR: Group C versus Group D||||0.612
73947353|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-5.31||||0.002|TWO_SIDED|95.0|-8.66|-1.97|||Mixed Models Analysis|||||-1.97|-8.66|0.002
73947354|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-8.4|||<|0.001|TWO_SIDED|95.0|-11.76|-5.04|||Mixed Models Analysis|||||-5.04|-11.76|<0.001
73947355|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-14.51|||<|0.001|TWO_SIDED|95.0|-18.0|-11.01|||Mixed Models Analysis|||||-11.01|-18.00|<0.001
73947356|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-14.15|||<|0.001|TWO_SIDED|95.0|-17.77|-10.54|||Mixed Models Analysis|||||-10.54|-17.77|<0.001
73947357|NCT04867785|147426919|SUPERIORITY||LSMean Difference|-15.22|||<|0.001|TWO_SIDED|95.0|-18.36|-12.07|||Mixed Models Analysis|||||-12.07|-18.36|<0.001
73947358|NCT03926065|147426943|SUPERIORITY|||||||0.126|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.1260
73947359|NCT03926065|147426943|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||<0.0001
73947360|NCT03926065|147426943|SUPERIORITY|||||||0.0992|||||||Mixed Models Analysis|||Interaction between Portion Size and Palatability||||0.0992
73947361|NCT03926065|147426944|SUPERIORITY|||||||0.5502|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.5502
73947362|NCT03926065|147426944|SUPERIORITY|||||||0.0072|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||0.0072
73947363|NCT03926065|147426945|SUPERIORITY|||||||0.103|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.1030
73947364|NCT03926065|147426945|SUPERIORITY|||||||0.0178|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||0.0178
73947365|NCT03926065|147426945|SUPERIORITY|||||||0.241|||||||Mixed Models Analysis|||Interaction between Portion Size and Palatability||||0.2410
73976526|NCT06307457|147499037|OTHER|||||||0.7|||||||Log Rank|||Statistical data for participants with metabolic disease comorbidity reported.||||0.7
73976527|NCT06307457|147499038|OTHER|||||||0.005|||||||Log Rank|||Statistical data for this outcome measure is provided combined for visceral disease status.||||0.005
73976528|NCT06307457|147499039|OTHER|||||||0.005|||||||Log Rank|||Statistical data for this outcome measure is provided combined for visceral disease status.||||0.005
73976529|NCT06307457|147499040|OTHER|||||||0.14|||||||Log Rank|||Statistical data for this outcome measure is provided combined for bone disease status.||||0.14
73976530|NCT06307457|147499041|OTHER|||||||0.2|||||||Log Rank|||Statistical data for this outcome measure is provided combined for bone disease status.||||0.2
73976531|NCT06307457|147499042|OTHER|||||||0.047|||||||Log Rank|||Statistical data for this outcome measure is provided combined for endocrine status.||||0.047
73976532|NCT06307457|147499043|OTHER|||||||0.041|||||||Log Rank|||Statistical data for this outcome measure is provided combined for endocrine status.||||0.041
73976533|NCT04401267|147499044|SUPERIORITY|||||||0.7139|||||||Fisher Exact|||||||0.7139
73976534|NCT02962284|147499071|SUPERIORITY||||||>|0.1|||||||ANCOVA|||||||>0.1
73976535|NCT01354444|147499094|OTHER||Coefficient|1.48||||0.565|TWO_SIDED|95.0|-3.796|6.761|||Regression, Linear|||This analysis compares immediate recall before and after 6 months between the treatment and placebo group.||6.761|-3.796|0.565
73976536|NCT01354444|147499095|OTHER|||||||0.481|||||||Rank sum test|||This analysis compares the change in total Tau between the treatment and placebo group from baseline to 6 months later.||||0.481
73976537|NCT01354444|147499095|OTHER|||||||0.0562|||||||Rank sum test|||This analysis compares the change in Abeta42 between the treatment and placebo group from baseline to 6 months later.||||0.0562
73976538|NCT01354444|147499095|OTHER|||||||0.314|||||||Rank sum test|||This analysis compares the change in p-tau between the treatment and placebo group from baseline to 6 months later.||||0.314
73976539|NCT01354444|147499095|OTHER|||||||0.438|||||||Rank sum test|||This analysis compares the change in oligomeric Abeta between the treatment and placebo group from baseline to 6 months later.||||0.438
73976540|NCT01613417|147499098|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||0.8516|TWO_SIDED|95.0|-4.6|5.6||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||5.6|-4.6|0.8516
73976541|NCT01613417|147499098|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.0||||1|TWO_SIDED|95.0|-3.8|3.8||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||3.8|-3.8|1.0
73976542|NCT01613417|147499098|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||1|TWO_SIDED|95.0|-0.5|1.5||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||1.5|-0.5|1.0
74032077|NCT02749721|147617308|OTHER||Pearson's R|-0.006||||0.988|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (Latency) baseline to endpoint percentage change||||0.988
74032078|NCT02749721|147617308|OTHER||Pearson's R|0.073||||0.788|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 (Latency) baseline to endpoint percentage change||||0.788
74032079|NCT02749721|147617308|OTHER||Pearson's R|0.375||||0.168|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a (Latency) baseline to endpoint percentage change||||0.168
74032080|NCT02749721|147617308|OTHER||Pearson's R|-0.392||||0.108|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (Latency) baseline scores||||0.108
74032081|NCT02749721|147617308|OTHER||Pearson's R|0.415||||0.124|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (Latency) baseline scores||||0.124
74032082|NCT02749721|147617308|OTHER||Pearson's R|0.362||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (Latency) baseline scores||||0.185
74032083|NCT02749721|147617308|OTHER||Pearson's R|-0.023||||0.923|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (Latency) baseline scores||||0.923
74032084|NCT02749721|147617308|OTHER||Pearson's R|0.071||||0.77|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (Latency) baseline scores||||0.77
73870346|NCT00483938|147284481|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||ETR: Group E versus Group F||||0.490
73976543|NCT01613417|147499099|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
73976544|NCT01613417|147499099|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
73976545|NCT01613417|147499099|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
73976546|NCT01613417|147499100|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
73976547|NCT01613417|147499100|SUPERIORITY_OR_OTHER|||||||0.6875|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||0.6875
73976548|NCT01613417|147499100|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
73976549|NCT01613417|147499101|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
73976550|NCT01613417|147499101|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
73976551|NCT01613417|147499101|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
73976552|NCT01613417|147499102|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
73976553|NCT01613417|147499102|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
73976554|NCT01613417|147499102|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
73976555|NCT01613417|147499103|SUPERIORITY_OR_OTHER|||||||0.2758|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.2758
73976556|NCT01613417|147499103|SUPERIORITY_OR_OTHER|||||||0.0676|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.0676
73976557|NCT01613417|147499103|SUPERIORITY_OR_OTHER|||||||0.5267|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.5267
74032085|NCT02749721|147617308|OTHER||Pearson's R|0.097||||0.712|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (Latency) baseline to endpoint percent change||||0.712
74032086|NCT02749721|147617308|OTHER||Pearson's R|-0.058||||0.845|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (Latency) baseline to endpoint percent change||||0.845
74032087|NCT02749721|147617308|OTHER||Pearson's R|0.194||||0.616|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (Latency) baseline to endpoint percent change||||0.616
73976558|NCT01613417|147499104|SUPERIORITY_OR_OTHER|||||||0.6201|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.6201
73976559|NCT01613417|147499104|SUPERIORITY_OR_OTHER|||||||0.4514|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.4514
73976560|NCT01613417|147499104|SUPERIORITY_OR_OTHER|||||||0.7722|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.7722
73976561|NCT01613417|147499105|SUPERIORITY_OR_OTHER|||||||0.3173|TWO_SIDED||||||McNemar|||||||0.3173
73976562|NCT01613417|147499105|SUPERIORITY_OR_OTHER|||||||0.5637|TWO_SIDED||||||McNemar|||||||0.5637
73976563|NCT01613417|147499105|SUPERIORITY_OR_OTHER|||||||0.0455|TWO_SIDED||||||McNemar|||||||0.0455
73976564|NCT01613417|147499106|SUPERIORITY_OR_OTHER|||||||0.6949|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.6949
73976565|NCT01613417|147499106|SUPERIORITY_OR_OTHER|||||||0.1317|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.1317
73976566|NCT01613417|147499106|SUPERIORITY_OR_OTHER|||||||0.0124|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.0124
73976567|NCT00705406|147499126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.222|TWO_SIDED|95.0|0.723|1.188|||Wilcoxon-Gehan test statistic|P-value is from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.|Hazard Ratio and corresponding 95% CI are based the Cox Regression Model including parameters for treatment, controlling for smoking status and hemisphere of enrollment.|||1.188|0.723|0.222
73976568|NCT00705406|147499127|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||van Elteren test|P-value for comparisons at all time points. P-value was based on the van Elteren test controlling for smoking status and hemisphere of enrollment.||||||>0.05
73976569|NCT00705406|147499128|SUPERIORITY_OR_OTHER|||||||0.421|TWO_SIDED||||||van Elteren test|P-value is based on van Elteren test controlling for smoking status and hemisphere of enrollment.||||||0.421
73976570|NCT00705406|147499129|SUPERIORITY_OR_OTHER|||||||0.885|TWO_SIDED||||||Wilcoxon-Gehan test statistic|P-values are from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.||||||0.885
73976571|NCT00705406|147499130|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value is based on the Cochran-Mantel-Haenszel general association test controlling for smoking status and hemisphere of enrollment.||||||0.306
73976572|NCT02927249|147499135|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.91|1.56||||||||1.56|0.91|
73976573|NCT02927249|147499136|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.74|1.69||||||||1.69|0.74|
73870347|NCT00483938|147284481|SUPERIORITY_OR_OTHER|||||||0.363|||||||Fisher Exact|||Complete EVR: Group C versus Group D||||0.363
73976574|NCT02927249|147499137|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.83|1.52||||||||1.52|0.83|
73976575|NCT04652726|147499147|SUPERIORITY||LS Mean|-28.54|||<|0.0001|TWO_SIDED|95.0|-35.81|-21.27|||ANCOVA|||||-21.27|-35.81|<.0001
73976576|NCT04652726|147499148|SUPERIORITY||LS Mean|-29.3|||<|0.0001|TWO_SIDED|95.0|-36.24|-22.36|||MMRM|||||-22.36|-36.24|<.0001
73976577|NCT04652726|147499149|SUPERIORITY||LS Mean|-49.99|||<|0.0001|TWO_SIDED|95.0|-63.18|-36.81|||ANCOVA|||||-36.81|-63.18|<.0001
73976578|NCT04652726|147499150|SUPERIORITY||LS Mean|-25.7|||<|0.0001|TWO_SIDED|95.0|-31.68|-19.73|||ANCOVA|||||-19.73|-31.68|<.0001
73976579|NCT04652726|147499151|SUPERIORITY||LS Mean|-6.18||||0.1419|TWO_SIDED|95.0|-17.48|5.12|||ANCOVA|||||5.12|-17.48|0.1419
73976580|NCT04652726|147499152|SUPERIORITY||LS Mean|-26.8|||<|0.0001|TWO_SIDED|95.0|-33.63|-19.97|||ANCOVA|||||-19.97|-33.63|<.0001
73976581|NCT04652726|147499153|SUPERIORITY||LS Mean|-19.2|||<|0.0001|TWO_SIDED|95.0|-24.65|-13.75|||ANCOVA|||||-13.75|-24.65|<.0001
73976582|NCT04200664|147499227|OTHER|Kendall tau b correlation analysis test was performed between the number of cognitive domains affected and the both ears 3-frequency pure tone average (at 0.5/1/2kHz) or both ears 4-frequency pure tone average (at 0.5/1/2/4kHz).|Kendall Tau-b|0.462||||0.176|TWO_SIDED||||||Kendall tau-b|Kendall tau b non-parametric correlation analysis was performed.||||||0.176
73976583|NCT01367236|147499236|SUPERIORITY|||||||0.68|||||||Regression, Linear|||24 weeks||||0.68
73976584|NCT01367236|147499236|SUPERIORITY|||||||0.43|||||||Regression, Linear|||48 weeks||||0.43
73976585|NCT01367236|147499237|SUPERIORITY|||||||0.0009|||||||Regression, Linear|||||||0.0009
73976586|NCT05785832|147499262|SUPERIORITY||Mean Difference (Net)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.8|-0.4|||Regression, Linear|||Adjusted Difference Between Groups||-0.4|-0.8|<0.001
73976587|NCT05785832|147499263|SUPERIORITY||Mean Difference (Net)|14.0|||<|0.001|TWO_SIDED|95.0|11.0|17.0|||Regression, Linear|||Adjusted Difference Between Groups||17|11|<0.001
73976588|NCT05785832|147499264|SUPERIORITY||Mean Difference (Net)|-21.0|||<|0.001|TWO_SIDED|95.0|-26.0|-15.0|||Regression, Linear|||Adjusted Difference Between Groups||-15|-26|<0.001
73976589|NCT05785832|147499265|SUPERIORITY||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-17.0|-11.0|||Regression, Linear|||Adjusted Difference Between Groups||-11|-17|<0.001
73976590|NCT05785832|147499266|SUPERIORITY||Mean Difference (Net)|-9.1|||<|0.001|TWO_SIDED|95.0|-11.7|-6.6|||Regression, Linear|||Adjusted Difference Between Groups||-6.6|-11.7|<0.001
73976591|NCT05785832|147499267|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4|||Regression, Linear|||Adjusted Difference Between Groups||-0.4|-1.0|<0.001
73976592|NCT05785832|147499268|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.4|0.1||A hierarchical procedure was used to control for the overall type I error. Since the P value for this outcome was more than 0.05, no additional P values are provided for subsequent secondary outcomes.|Regression, Linear|||Adjusted Difference Between Groups||0.1|-0.4|
73976593|NCT05785832|147499269|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.09|0.04|||Regression, Linear|||Adjusted Difference Between Groups||0.04|-0.09|
73976594|NCT05785832|147499270|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.0|||Regression, Linear|||Adjusted Difference Between Groups||0.0|-0.1|
73976595|NCT05785832|147499271|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||Regression, Linear|||Adjusted Difference Between Groups||1.2|-0.5|
73976596|NCT05785832|147499272|SUPERIORITY||Difference in percent of participants.|12.0|||||TWO_SIDED|95.0|1.0|21.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||21|1|
73976597|NCT05785832|147499273|SUPERIORITY||Difference in percent of participants.|18.0|||||TWO_SIDED|95.0|2.0|32.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||32|2|
73976598|NCT05785832|147499274|SUPERIORITY||Difference in percent of participants.|23.0|||||TWO_SIDED|95.0|12.0|33.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||33|12|
73976599|NCT05785832|147499275|SUPERIORITY||Difference in percent of participants.|25.0|||||TWO_SIDED|95.0|11.0|38.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||38|11|
73976600|NCT05785832|147499276|SUPERIORITY||Difference in percent of participants.|22.0|||||TWO_SIDED|95.0|11.0|33.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||33|11|
73976601|NCT05785832|147499277|SUPERIORITY||Difference in percent of participants.|21.0|||||TWO_SIDED|95.0|10.0|32.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||32|10|
73976602|NCT05785832|147499278|SUPERIORITY||Difference in percent of participants.|21.0|||||TWO_SIDED|95.0|9.0|31.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||31|9|
73976603|NCT05785832|147499279|SUPERIORITY||Median Difference (Net)|10.0|||||TWO_SIDED|95.0|7.0|12.0||||||Adjusted Difference Between Groups||12|7|
73976604|NCT05785832|147499280|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.02|0.01||||||||0.01|-0.02|
73976605|NCT05785832|147499281|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.07|0.01||||||Adjusted Difference Between Groups||0.01|-0.07|
73976606|NCT05785832|147499282|SUPERIORITY||Mean Difference (Net)|-4.4|||||TWO_SIDED|95.0|-6.0|-2.7||||||Adjusted Difference Between Groups||-2.7|-6.0|
73976607|NCT05785832|147499283|SUPERIORITY||Mean Difference (Net)|-14.0|||||TWO_SIDED|95.0|-18.0|-10.0||||||Adjusted Difference Between Groups||-10|-18|
73976608|NCT05785832|147499284|SUPERIORITY||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-5.2|-2.7||||||Adjusted Difference Between Groups||-2.7|-5.2|
73976609|NCT05785832|147499285|SUPERIORITY||Difference in percent of participants.|16.0|||||TWO_SIDED|95.0|8.0|24.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||24|8|
74032088|NCT02749721|147617308|OTHER||Pearson's R|0.255||||0.323|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (Latency) baseline to endpoint percent change||||0.323
73976610|NCT05785832|147499286|SUPERIORITY||Difference in percent of participants.|26.0|||||TWO_SIDED|95.0|12.0|41.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||41|12|
73976611|NCT05785832|147499287|SUPERIORITY||Difference in percent of participants.|34.0|||||TWO_SIDED|95.0|21.0|45.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||45|21|
73976612|NCT05785832|147499290|SUPERIORITY||Difference in percent of participants.|15.0|||||TWO_SIDED|95.0|8.0|22.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||22|8|
73976613|NCT05785832|147499291|SUPERIORITY||Mean Difference (Net)|-10.0|||||TWO_SIDED|95.0|-20.0|0.0||||||Adjusted Difference Between Groups.||0|-20|
73976614|NCT05785832|147499292|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-4.4|3.4||||||Adjusted Difference Between Groups.||3.4|-4.4|
73976615|NCT05785832|147499293|SUPERIORITY||Median Difference (Net)|1.5|||||TWO_SIDED|95.0|0.5|2.5||||||Adjusted Difference Between Groups.||2.5|0.5|
73976616|NCT05785832|147499294|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-2.5|4.7||||||Adjusted Difference Between Groups.||4.7|-2.5|
73976617|NCT05785832|147499295|SUPERIORITY||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.4|0.7||||||Adjusted Difference Between Groups.||0.7|-3.4|
73976618|NCT05785832|147499296|SUPERIORITY||Median Difference (Net)|2.1|||||TWO_SIDED|95.0|0.5|3.7||||||Adjusted Difference Between Groups.||3.7|0.5|
73976619|NCT05785832|147499297|SUPERIORITY||Mean Difference (Net)|4.9|||||TWO_SIDED|95.0|-1.4|11.1||||||Adjusted Difference Between Groups.||11.1|-1.4|
73976620|NCT05785832|147499298|SUPERIORITY||Mean Difference (Net)|-20.0|||||TWO_SIDED|95.0|-45.0|4.0||||||Adjusted Difference Between Groups.||4|-45|
73976621|NCT00357994|147499317|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.91|STANDARD_ERROR_OF_MEAN|0.57||0.0015|TWO_SIDED|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA|||||-0.76|-3.05|0.0015
73976622|NCT00357994|147499318|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.86|STANDARD_ERROR_OF_MEAN|0.65||0.0059|TWO_SIDED|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||3.17|0.56|0.0059
73976623|NCT00357994|147499319|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-7.0|STANDARD_ERROR_OF_MEAN|2.8||0.0155|TWO_SIDED|95.0|-12.6|-1.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-1.4|-12.6|0.0155
73976624|NCT00357994|147499320|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0258|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.1|-1.4|0.0258
74032089|NCT02749721|147617308|OTHER||Pearson's R|-0.193||||0.473|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (Latency) baseline to endpoint percent change||||0.473
73870348|NCT00483938|147284481|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Complete EVR: Group E versus Group F||||1.000
74089268|NCT02697773|147731611|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0004|TWO_SIDED|95.0|1.37|3.04|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.37|0.0004
73947366|NCT03926065|147426946|SUPERIORITY|||||||0.0012|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.0012
73947367|NCT03926065|147426946|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||<0.0001
73947368|NCT02714868|147426962|OTHER|||||||0.05|||||||t-test, 2 sided|||For goal attainment, we calculated independent t-tests to compare GAS t-scores across groups at outcome. Lowest score is 0, highest score is 100. 100 is highest goal attainment.||||.05
73947369|NCT00981474|147426968|SUPERIORITY||Risk Ratio (RR)|0.96||||0.752|TWO_SIDED|95.0|0.82|1.121|||Chi-squared|||||1.121|.82|.752
73947370|NCT00981474|147426969|SUPERIORITY||Risk Ratio (RR)|0.55||||0.053|TWO_SIDED|95.0|0.32|0.93|||Chi-squared|||||.93|.32|.053
73947371|NCT00981474|147426970|SUPERIORITY||Risk Ratio (RR)|0.454||||0.149|TWO_SIDED|95.0|0.18|1.17|||Chi-squared|||||1.17|.18|.149
73947372|NCT00981474|147426971|SUPERIORITY||Hazard Ratio (HR)|0.581||||0.144|TWO_SIDED|95.0|0.3|1.13|||Chi-squared|||||1.13|.30|.144
73947373|NCT00981474|147426972|SUPERIORITY||Risk Ratio (RR)|0.724||||0.439|TWO_SIDED|95.0|0.37|1.41|||Chi-squared|||||1.41|.37|.439
73947374|NCT00981474|147426973|SUPERIORITY||Risk Ratio (RR)|0.872||||0.311|TWO_SIDED|95.0|0.69|1.11|||Chi-squared|||||1.11|.69|.311
73947375|NCT00981474|147426974|SUPERIORITY||Risk Ratio (RR)|0.247||||0.103|TWO_SIDED|95.0|0.005|1.18|||Fisher Exact|Fisher exact test used due to the small number of events.||||1.18|.005|.103
73947376|NCT00981474|147426975|SUPERIORITY||Risk Ratio (RR)|1.102||||0.608|TWO_SIDED|95.0|0.81|1.5|||Chi-squared|||||1.5|.81|.608
73947377|NCT00981474|147426976|SUPERIORITY||Risk Ratio (RR)|0.564||||0.541|TWO_SIDED|95.0|0.16|1.97|||Fisher Exact|Fisher exact test used due to the small number of events.||||1.97|.16|.541
73947378|NCT00981474|147426977|SUPERIORITY||Risk Ratio (RR)|0.247||||0.103|TWO_SIDED|95.0|0.05|1.18|||Fisher Exact|Fisher exact test used due to small number of events.||||1.18|.05|.103
73947379|NCT00981474|147426978|SUPERIORITY||Risk Ratio (RR)|0.409||||0.129|TWO_SIDED|95.0|0.15|1.14|||Chi-squared|||||1.14|.15|.129
73947380|NCT00708526|147426987|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|A Bonferroni correction was used.||We compared times for discharge criteria after general anesthesia with and without the QED.||||>0.05
73870349|NCT02218008|147284482|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.018|TWO_SIDED|95.0|-2.7|-0.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.||-0.3|-2.7|0.018
73947381|NCT00708526|147426988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||t-test, 2 sided|||The effect of the use of hypercapnia and increased ventilation on the time to recovery events was compared using multivariate analysis of variance with the Hotelling's two sample T2.-test and the two-tailed unpaired t-test; individual comparisons were by Bonferroni adjusted two tailed unpaired t-tests. The data was tested for normality before identifying statistical significance.||||0.039
73947382|NCT01678820|147427040|SUPERIORITY_OR_OTHER||Difference in least squares means|0.19||||0.267|TWO_SIDED|95.0|-0.14|0.52|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment||||0.52|-0.14|0.267
73947383|NCT01678820|147427041|SUPERIORITY_OR_OTHER||Difference in percents|-0.4|||||TWO_SIDED|95.0|-10.2|9.3|||||Based on Miettinen \& Nurminen method|||9.3|-10.2|
73947384|NCT01678820|147427041|SUPERIORITY_OR_OTHER||Difference in percents|-4.3|||||TWO_SIDED|95.0|-14.7|5.8|||||Based on Miettinen \& Nurminen method|||5.8|-14.7|
73947385|NCT01678820|147427043|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62|||<|0.001|TWO_SIDED|95.0|-0.95|-0.28|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-0.28|-0.95|<0.001
73947386|NCT01678820|147427044|SUPERIORITY_OR_OTHER||Difference in least squares means|1.7||||0.856|TWO_SIDED|95.0|-17.1|20.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||20.6|-17.1|0.856
73947387|NCT01678820|147427044|SUPERIORITY_OR_OTHER||Difference in least squares means|-29.2||||0.002|TWO_SIDED|95.0|-47.9|-10.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-10.6|-47.9|0.002
73947388|NCT01678820|147427045|SUPERIORITY_OR_OTHER||Difference in least squares means|-25.6|||<|0.001|TWO_SIDED|95.0|-35.6|-15.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-15.6|-35.6|<0.001
73947389|NCT01678820|147427045|SUPERIORITY_OR_OTHER||Difference in least squares means|5.3||||0.286|TWO_SIDED|95.0|-4.5|15.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||15.2|-4.5|0.286
73947390|NCT01678820|147427046|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.1|||<|0.001|TWO_SIDED|95.0|-24.2|-12.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-12.0|-24.2|<0.001
73947391|NCT01678820|147427046|SUPERIORITY_OR_OTHER||Difference in least squares means|0.0||||0.99|TWO_SIDED|95.0|-6.0|6.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||6.0|-6.0|0.990
73947392|NCT01678820|147427047|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.2|||<|0.001|TWO_SIDED|95.0|-28.3|-12.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-12.2|-28.3|<0.001
73947393|NCT01678820|147427047|SUPERIORITY_OR_OTHER||Difference in least squares means|2.9||||0.469|TWO_SIDED|95.0|-5.0|10.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||10.7|-5.0|0.469
73947394|NCT01678820|147427048|SUPERIORITY_OR_OTHER||Difference in least squares means|-24.4|||<|0.001|TWO_SIDED|95.0|-32.6|-16.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-16.3|-32.6|<0.001
73947395|NCT01678820|147427048|SUPERIORITY_OR_OTHER||Difference in least squares means|0.3||||0.937|TWO_SIDED|95.0|-7.7|8.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||8.3|-7.7|0.937
73947396|NCT01678820|147427049|SUPERIORITY_OR_OTHER||Difference in estimated means|-15.5||||0.068|TWO_SIDED|95.0|-32.2|1.2|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.||||1.2|-32.2|0.068
73947397|NCT01678820|147427049|SUPERIORITY_OR_OTHER||Difference in estimated means|-10.3||||0.365|TWO_SIDED|95.0|-33.6|13.0|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.||||13.0|-33.6|0.365
73947398|NCT01678820|147427050|SUPERIORITY_OR_OTHER||Difference in least squares means|0.5||||0.857|TWO_SIDED|95.0|-4.8|5.8|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.8|-4.8|0.857
73947399|NCT01678820|147427050|SUPERIORITY_OR_OTHER||Difference in least squares means|0.4||||0.879|TWO_SIDED|95.0|-4.8|5.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.6|-4.8|0.879
73947400|NCT01678820|147427051|SUPERIORITY_OR_OTHER||Difference in least squares means|-30.4||||0.004|TWO_SIDED|95.0|-51.0|-9.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-9.7|-51.0|0.004
73947401|NCT01678820|147427051|SUPERIORITY_OR_OTHER||Difference in least squares means|-15.3||||0.141|TWO_SIDED|95.0|-35.8|5.1|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.1|-35.8|0.141
73947402|NCT01678820|147427052|SUPERIORITY_OR_OTHER||Difference in percents|0.3|||||TWO_SIDED|95.0|-12.2|12.9|||||Based on Miettinen \& Nurminen method. Missing data were imputed by multiple impuattions.|||12.9|-12.2|
73947403|NCT01678820|147427052|SUPERIORITY_OR_OTHER||Difference in percents|12.3|||||TWO_SIDED|95.0|0.7|24.0|||||Based on Miettinen \& Nurminen method. Missing data were imputed by multiple imputations.|||24.0|0.7|
73947404|NCT01187329|147427056|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.11|TWO_SIDED|97.5|-2.87|0.48|||t-test, 2 sided|||||0.48|-2.87|0.11
73947405|NCT01187329|147427057|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.007|TWO_SIDED|97.5|-0.3|-0.01|||t-test, 2 sided|paired t-test||||-0.01|-0.3|0.007
73947406|NCT01187329|147427058|SUPERIORITY||Median Difference (Final Values)|-0.6||||0.57|TWO_SIDED|95.0|-2.6|1.5|||t-test, 2 sided|||||1.5|-2.6|0.57
73947407|NCT01187329|147427059|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.45|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||||0.1|-0.2|0.45
73947408|NCT05266963|147427061|SUPERIORITY|Statistical analysis will be performed using a paired samples Wilcoxon test to compare differences between the two groups.||||||0.43|||||||Wilcoxon (Mann-Whitney)|Wilcoxon matched-pairs||||||0.43
73947409|NCT05266963|147427062|SUPERIORITY|Statistical analysis will be performed using a standard two-tailed t test to compare differences between the two groups.||||||0.52|||||||t-test, 2 sided|||||||0.52
73947410|NCT00393523|147427080|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|95.0|||<|0.001||95.2|92.1|97.1||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||97.1|92.1|<0.001
73947411|NCT00393523|147427080|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|95.0|||<|0.001||97.6|91.6|97.3||Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024). Since only one group met the criteria, that group was retested at α=.012.|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||97.3|91.6|<0.001
73976625|NCT00357994|147499321|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.0086|TWO_SIDED|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.8|-5.3|0.0086
73947412|NCT00393523|147427080|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|91.6||||0.19||95.2|88.0|94.4||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||94.4|88.0|0.19
73947413|NCT00393523|147427081|SUPERIORITY_OR_OTHER||Seroprotection Rate (SPR)|97.3||||||95.0|95.0|98.8|||||"Exact binomial confidence interval~Seroprotection Rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL"|The purpose of the secondary analysis is to demonstrate that there is an adequate SPR in subjects who received a primary vaccination series of ENGERIX-B™ and a booster dose of modified process hepatitis B vaccine. An adequate response requires the lower bound of the two-sided 95% confidence interval for the SPR to exceed 90%.||98.8|95.0|
73947414|NCT04091360|147427088|OTHER||GeoMean Ratio|1.221|||<|0.0001|TWO_SIDED|95.0|1.163|1.281|||ANCOVA|||||1.281|1.163|<0.0001
73947415|NCT04091360|147427088|OTHER||GeoMean Ratio|1.203|||<|0.0001|TWO_SIDED|95.0|1.146|1.263|||ANCOVA|||||1.263|1.146|<0.0001
73947416|NCT04091360|147427088|OTHER||GeoMean Ratio|1.139|||<|0.0001|TWO_SIDED|95.0|1.085|1.195|||ANCOVA|||||1.195|1.085|<0.0001
73947417|NCT04091360|147427089|OTHER||GeoMean Ratio|1.253|||<|0.0001|TWO_SIDED|95.0|1.151|1.363|||ANCOVA|||||1.363|1.151|<0.0001
73947418|NCT04091360|147427089|OTHER||GeoMean Ratio|1.146||||0.0022|TWO_SIDED|95.0|1.054|1.246|||ANCOVA|||||1.246|1.054|0.0022
73947419|NCT04091360|147427089|OTHER||GeoMean Ratio|1.102||||0.0295|TWO_SIDED|95.0|1.01|1.202|||ANCOVA|||||1.202|1.010|0.0295
73947420|NCT04091360|147427089|OTHER||GeoMean Ratio|1.129||||0.0098|TWO_SIDED|95.0|1.032|1.235|||ANCOVA|||||1.235|1.032|0.0098
73947421|NCT04091360|147427089|OTHER||GeoMean Ratio|1.028||||0.54|TWO_SIDED|95.0|0.939|1.125|||ANCOVA|||||1.125|0.939|0.54
73947422|NCT04091360|147427090|OTHER||GeoMean Ratio|1.228|||<|0.0001|TWO_SIDED|95.0|1.142|1.319|||ANCOVA|||||1.319|1.142|<0.0001
73947423|NCT04091360|147427090|OTHER||GeoMean Ratio|1.155||||0.0002|TWO_SIDED|95.0|1.075|1.24|||ANCOVA|||||1.240|1.075|0.0002
73947424|NCT04091360|147427090|OTHER||GeoMean Ratio|1.1||||0.0129|TWO_SIDED|95.0|1.022|1.184|||ANCOVA|||||1.184|1.022|0.0129
73947425|NCT04091360|147427090|OTHER||GeoMean Ratio|1.112||||0.0079|TWO_SIDED|95.0|1.03|1.201|||ANCOVA|||||1.201|1.030|0.0079
73947426|NCT04091360|147427090|OTHER||GeoMean Ratio|1.033||||0.39|TWO_SIDED|95.0|0.957|1.116|||ANCOVA|||||1.116|0.957|0.39
73947427|NCT04091360|147427091|OTHER||GeoMean Ratio|1.137|||<|0.0001|TWO_SIDED|95.0|1.073|1.204|||ANCOVA|||||1.204|1.073|<0.0001
73947428|NCT04091360|147427091|OTHER||GeoMean Ratio|1.091||||0.0041|TWO_SIDED|95.0|1.03|1.155|||ANCOVA|||||1.155|1.030|0.0041
73947429|NCT04091360|147427091|OTHER||GeoMean Ratio|1.019||||0.53|TWO_SIDED|95.0|0.96|1.081|||ANCOVA|||||1.081|0.960|0.53
73947430|NCT04091360|147427099|OTHER||GeoMean Ratio|1.21|||<|0.0001|TWO_SIDED|95.0|1.153|1.27|||ANCOVA|||||1.270|1.153|<0.0001
73947431|NCT04091360|147427099|OTHER||GeoMean Ratio|1.193|||<|0.0001|TWO_SIDED|95.0|1.136|1.252|||ANCOVA|||||1.252|1.136|<0.0001
73947432|NCT04091360|147427099|OTHER||GeoMean Ratio|1.124|||<|0.0001|TWO_SIDED|95.0|1.071|1.179|||ANCOVA|||||1.179|1.071|<0.0001
73947433|NCT04091360|147427100|OTHER||GeoMean Ratio|1.139|||<|0.0001|TWO_SIDED|95.0|1.087|1.194|||ANCOVA|||||1.194|1.087|<0.0001
73947434|NCT04091360|147427100|OTHER||GeoMean Ratio|1.142|||<|0.0001|TWO_SIDED|95.0|1.089|1.197|||ANCOVA|||||1.197|1.089|<0.0001
73947435|NCT04091360|147427100|OTHER||GeoMean Ratio|1.08||||0.0018|TWO_SIDED|95.0|1.031|1.132|||ANCOVA|||||1.132|1.031|0.0018
73947436|NCT04091360|147427101|OTHER||GeoMean Ratio|1.08||||0.0066|TWO_SIDED|95.0|1.022|1.14|||ANCOVA|||||1.140|1.022|0.0066
73947437|NCT04091360|147427101|OTHER||GeoMean Ratio|1.074||||0.0115|TWO_SIDED|95.0|1.017|1.134|||ANCOVA|||||1.134|1.017|0.0115
73947438|NCT04091360|147427101|OTHER||GeoMean Ratio|1.037||||0.18|TWO_SIDED|95.0|0.982|1.096|||ANCOVA|||||1.096|0.982|0.18
73947439|NCT04091360|147427102|OTHER||GeoMean Ratio|1.162|||<|0.0001|TWO_SIDED|95.0|1.122|1.203|||ANCOVA|||||1.203|1.122|<0.0001
73947440|NCT04091360|147427102|OTHER||GeoMean Ratio|1.15|||<|0.0001|TWO_SIDED|95.0|1.111|1.19|||ANCOVA|||||1.190|1.111|<0.0001
73947441|NCT04091360|147427102|OTHER||GeoMean Ratio|1.112|||<|0.0001|TWO_SIDED|95.0|1.074|1.152|||ANCOVA|||||1.152|1.074|<0.0001
73947442|NCT04091360|147427103|OTHER||GeoMean Ratio|1.157|||<|0.0001|TWO_SIDED|95.0|1.119|1.196|||ANCOVA|||||1.196|1.119|<0.0001
73947443|NCT04091360|147427103|OTHER||GeoMean Ratio|1.147|||<|0.0001|TWO_SIDED|95.0|1.11|1.186|||ANCOVA|||||1.186|1.110|<0.0001
73947444|NCT04091360|147427103|OTHER||GeoMean Ratio|1.105|||<|0.0001|TWO_SIDED|95.0|1.068|1.142|||ANCOVA|||||1.142|1.068|<0.0001
73947445|NCT04091360|147427104|OTHER||GeoMean Ratio|1.098|||<|0.0001|TWO_SIDED|95.0|1.059|1.137|||ANCOVA|||||1.137|1.059|<0.0001
73947446|NCT04091360|147427104|OTHER||GeoMean Ratio|1.111|||<|0.0001|TWO_SIDED|95.0|1.072|1.15|||ANCOVA|||||1.150|1.072|<0.0001
73947447|NCT04091360|147427104|OTHER||GeoMean Ratio|1.07||||0.0003|TWO_SIDED|5.0|1.033|1.109|||ANCOVA|||||1.109|1.033|0.0003
73947448|NCT04091360|147427105|OTHER||Median Difference (Final Values)|8.5||||0.47|TWO_SIDED||||||Hodges-Lehmann|||||||0.47
73947449|NCT04091360|147427105|OTHER||Mean Difference (Final Values)|18.0||||0.0059|TWO_SIDED||||||Hodges-Lehmann|||||||0.0059
73947450|NCT00744263|147427126|SUPERIORITY_OR_OTHER||Vaccine Efficacy|45.56||||0.0006|TWO_SIDED|95.2|21.82|62.49|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1 - (proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||62.49|21.82|0.0006
73947451|NCT00744263|147427127|SUPERIORITY_OR_OTHER||Vaccine Efficacy|45.0||||0.0067|TWO_SIDED|95.2|14.21|65.31|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||65.31|14.21|0.0067
74089269|NCT02697773|147731611|SUPERIORITY||Odds Ratio (OR)|1.27||||0.2283|TWO_SIDED|95.0|0.86|1.87|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.87|0.86|0.2283
73947452|NCT00744263|147427128|SUPERIORITY_OR_OTHER||Vaccine Efficacy|75.0||||0.0005|TWO_SIDED|95.0|41.43|90.78|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||90.78|41.43|0.0005
73947453|NCT00744263|147427131|SUPERIORITY_OR_OTHER|||||||0.979|TWO_SIDED||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.||||0.979
73947454|NCT00744263|147427132|SUPERIORITY_OR_OTHER|||||||0.455|TWO_SIDED||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.||||0.455
73947455|NCT01515189|147427145|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.04|TWO_SIDED|95.0|0.7|0.99||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model|||0.99|0.70|0.0400
73947456|NCT01515189|147427146|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1548|TWO_SIDED|95.0|0.76|1.04||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model|||1.04|0.76|0.1548
73947457|NCT01515189|147427152|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.49|1.04|||||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg. Based on an unstratified Cox proportional hazards model for subset of participants with brain metastases.|||1.04|0.49|
73947458|NCT02583763|147427167|SUPERIORITY||||||>|0.05||||||Significance value stated as p\<0.05|t-test, 2 sided|||Paired sample T test were used to analyse normally distributed data.||||>0.05
73947459|NCT02583763|147427168|SUPERIORITY||||||>|0.05||||||Significance value was stated as p\<0.05|t-test, 2 sided|||||||>0.05
73947460|NCT02583763|147427169|SUPERIORITY|||||||0.003||||||Significance value was set to p\<0.05|t-test, 2 sided|||||||0.003
73947461|NCT05458024|147427175|SUPERIORITY||Beta coefficient|-0.14||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
73947462|NCT05458024|147427176|SUPERIORITY||Beta coefficient|-1.41||||0.21|TWO_SIDED|||||Analyses were adjusted for sex, baseline pain, and baseline vitamin D levels.|Mixed Models Analysis|||||||0.21
73947463|NCT03635489|147427231|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.53|||Regression, Cox|||||0.53|0.17|<.0001
73947464|NCT03635489|147427231|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.2|0.58|||Regression, Cox|||||0.58|0.20|<.0001
73947465|NCT03635489|147427232|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.3|1.21||||||||1.21|0.30|
73947466|NCT00971750|147427259|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||Chi-squared|||||||0.763
73947467|NCT00971750|147427261|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73947468|NCT01807650|147427262|SUPERIORITY_OR_OTHER||||||=|0.0232||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments."||||=0.0232
73947469|NCT01807650|147427266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_DEVIATION|17.8|=|0.0005|TWO_SIDED|95.0|2.7|9.4||Day 7|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.4|2.7|=0.0005
73947470|NCT01807650|147427266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_DEVIATION|16.9|=|0.0002|TWO_SIDED|95.0|3.0|9.4||Day 10|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.4|3.0|=0.0002
73947471|NCT01807650|147427266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|19.3|=|0.0028|TWO_SIDED|95.0|2.0|9.3||Day 14|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.3|2.0|=0.0028
73947472|NCT01807650|147427266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|STANDARD_DEVIATION|18.0|=|0.0009|TWO_SIDED|95.0|2.5|9.3||Day 18|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.3|2.5|=0.0009
73947473|NCT01807650|147427266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|15.8|=|0.0003|TWO_SIDED|95.0|2.6|8.6||Day 21|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||8.6|2.6|=0.0003
73947474|NCT01807650|147427266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|15.1|=|0.0145|TWO_SIDED|95.0|0.7|6.4||Day 28|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||6.4|0.7|=0.0145
73947475|NCT00663117|147427303|SUPERIORITY_OR_OTHER|||||||0.009||||||The percentage of subjects achieving a 70-point drop in CDAI score in naltrexone treated subjects was the percentage acheiving the same drop in the placebo controls|Fisher Exact|||The proportion of those achieving a response with a 70-point decline in CDAI score was compared between naltrexone and placebo treated subjects using the Fisher's exact test. Analysis was performed with the intent-to-treat criteria. Clinical significance was accepted if the difference met 95% confidence (p\<0.05).||||0.009
73947476|NCT00663117|147427305|SUPERIORITY_OR_OTHER|||||||0.008|ONE_SIDED|95.0|||||Fisher Exact|||Percentage of patients having a 5-point decline in the endoscopic inflammation score||||0.008
73947477|NCT00663117|147427306|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||t-test, 1 sided|||||||0.048
73947478|NCT00840996|147427333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|97.5|-1.23|-0.4||Test for superiority adjusted for 2 primary comparisons (2 outcomes)|Mixed Models Analysis|Llinear mixed-effects accounts for correlation exhibited by the repeated pain measurements on a given patient (spatial power correlation structure).||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .||-0.40|-1.23|<0.001
73947479|NCT00840996|147427334|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: ratio of the geometric means not more than 1.3 greater (mean mg IV morphine equivalent not more than 30% greater ) than that of the other group|the ratio of the geometric means|0.8||||0.011|TWO_SIDED|95.0|0.65|1.21||Noninferiority hypotheses were evaluated against a one-sided significance criterion of 0.025 \[adjusting for testing in both directions: lidocaine vs. control and vs. control vs. lidocaine \]|Regression, Linear|Log-linear regression model was used; 0.1 mg added before taking the logarithm to accommodate the 2 patients who received 0 mg opioids.||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .||1.21|0.65|0.011
73947480|NCT00840996|147427335|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.049|TWO_SIDED|95.0|0.84|1.0|||Regression, Logistic|||||1.00|0.84|0.049
73947481|NCT00840996|147427336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.31|TWO_SIDED|95.0|0.77|1.09|||Regression, Logistic|||Nausea - POD 2||1.09|0.77|0.31
73947482|NCT00840996|147427336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.44|TWO_SIDED|95.0|0.94|1.14|||Regression, Logistic|||Vomiting - POD 2||1.14|0.94|0.44
73947483|NCT00840996|147427337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.15|TWO_SIDED|95.0|-2.4|0.4|||Regression, Linear|||||0.4|-2.4|0.15
73947484|NCT00840996|147427338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.002|TWO_SIDED|95.0|2.3|10.0|||Regression, Linear|||||10|2.3|0.002
73947485|NCT00840996|147427339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.04|TWO_SIDED|95.0|0.3|8.9|||Regression, Logistic|||||8.9|0.3|0.04
73947486|NCT03285295|147427340|SUPERIORITY||Clinical Specificity (%)|99.96|||||TWO_SIDED|95.0|99.92|99.99|||Binomial Distribution|Specificity sample size is a minimum of 15,000 donors.||||99.99|99.92|
73947487|NCT03285295|147427341|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.15|100.0|||Sensitivity|||||100.00|99.15|
73947488|NCT03285295|147427342|SUPERIORITY||Clinical Specificity (%)|99.99|||||TWO_SIDED|95.0|99.95|100.0|||Binomial Distribution|||||100.00|99.95|
73947489|NCT03285295|147427343|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.48|100.0|||Sensitivity|||||100.00|99.48|
73947490|NCT03285295|147427344|SUPERIORITY||Clinical Specificity (%)|99.92|||||TWO_SIDED|95.0|99.86|99.95|||Binomial Distribution|||||99.95|99.86|
73947491|NCT03285295|147427345|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
73947492|NCT03285295|147427346|SUPERIORITY||Clinical Specificity (%)|99.92|||||TWO_SIDED|95.0|99.87|99.96|||Binomial Exact|||||99.96|99.87|
73947493|NCT03285295|147427347|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.72|100.0|||Sensitivity|||||100.00|99.72|
73947494|NCT03285295|147427348|SUPERIORITY||Clinical Specificity (%)|99.9|||||TWO_SIDED|95.0|99.84|99.94|||Binomial Exact|||||99.94|99.84|
73947495|NCT03285295|147427349|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
73947496|NCT03285295|147427350|SUPERIORITY||Clinical Specificity (%)|99.98|||||TWO_SIDED|95.0|99.94|100.0|||Binomial Exact|||||100.00|99.94|
73947497|NCT03285295|147427351|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|98.85|100.0|||Sensitivity|||||100.00|98.85|
73947498|NCT03285295|147427356|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|95.98|100.0|||Sensitivity|||Sensitivity||100.00|95.98|
73947499|NCT03285295|147427358|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|92.75|100.0|||Sensitivity|||Sensitivity||100.00|92.75|
73947500|NCT03285295|147427359|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|94.87|100.0|||Sensitivity|||Sensitivity||100.00|94.87|
73947501|NCT03285295|147427360|OTHER|95% Confidence Interval provided.|Point Estimate|98.65|||||TWO_SIDED|95.0|95.2|99.84|||Sensitivity|||Sensitivity||99.84|95.20|
73947502|NCT03239873|147427375|NON_INFERIORITY|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-2.7|2.8|||Miettinen and Nurminen|||||2.8|-2.7|<0.001
73947503|NCT03239873|147427375|OTHER|Acceptability|Antibody Response Rate|98.4|||<|0.001|TWO_SIDED|95.0|95.9|99.6|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being \>76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).||99.6|95.9|<0.001
73947504|NCT03239873|147427376|NON_INFERIORITY|The statistical criterion for noninferiority of the GMT corresponds to the lower bound of the 2-sided 95% CI on the GMT ratio \[VARIVAX® PE34 process/VARIVAX® 2016 commercial product\] being \>0.67.|Risk Difference (RD)|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||Miettinen and Nurminen|||||1.1|0.9|<0.001
73947505|NCT03239873|147427377|OTHER||Difference in Percentage|2.0||||0.436|TWO_SIDED|95.0|-3.1|7.1|||Miettinen & Nurminen|||Up to 42 days after Vaccination 1||7.1|-3.1|0.436
73947506|NCT03239873|147427377|OTHER||Difference in Percentage|2.9||||0.204|TWO_SIDED|95.0|-1.6|7.5|||Miettinen & Nurminen|||Up to 42 days after Vaccination 2||7.5|-1.6|0.204
73947507|NCT03239873|147427378|OTHER||Difference in Percentage|-1.3||||0.102|TWO_SIDED|95.0|-3.5|0.4|||Miettinen & Nurminen|||Measles-like rash||0.4|-3.5|0.102
73947508|NCT03239873|147427378|OTHER||Difference in Percentage|0.3||||0.317|TWO_SIDED|95.0|-0.9|1.9|||Miettinen & Nurminen|||Rubella-like rash||1.9|-0.9|0.317
73947509|NCT03239873|147427378|OTHER||Difference in Percentage|1.3||||0.241||95.0|-1.0|4.0|||Miettinen & Nurminen|||Varicella-like rash||4.0|-1.0|0.241
73947510|NCT03239873|147427378|OTHER||Difference in Percentage|-0.3||||0.318|TWO_SIDED|95.0|-1.9|0.9|||Miettinen & Nurminen|||Zoster-like rash||0.9|-1.9|0.318
73947511|NCT03239873|147427379|OTHER||Difference in Percentage|1.1||||0.17|TWO_SIDED|95.0|-0.7|3.4|||Miettinen & Nurminen|||Measles-like rash||3.4|-0.7|0.170
73947512|NCT03239873|147427379|OTHER||Difference in Percentage|-0.3||||0.576|TWO_SIDED|95.0|-2.2|1.4|||Miettinen & Nurminen|||Varicella-like rash||1.4|-2.2|0.576
73947513|NCT03239873|147427379|OTHER||Difference in Percentage|0.4||||0.312|TWO_SIDED|95.0|-1.0|2.0|||Miettinen & Nurminen|||Zoster-like rash||2.0|-1.0|0.312
73976626|NCT00357994|147499322|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.502|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||5.6|-2.8|0.5020
73976627|NCT00357994|147499323|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.07|STANDARD_ERROR_OF_MEAN|0.038||0.067|TWO_SIDED|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||0.146|-0.005|0.0670
73976628|NCT00357994|147499324|SUPERIORITY_OR_OTHER||Treament Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.1||0.1501|TWO_SIDED|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||1.7|-10.7|0.1501
74032090|NCT02749721|147617308|OTHER||F statistic|4.909||||0.031|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.031
74032091|NCT02749721|147617308|OTHER||F statistic|1.189||||0.281|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.281
73947514|NCT03239873|147427380|OTHER||Difference of Percentage|-1.0||||0.696|TWO_SIDED|95.0|-5.9|4.0|||Miettinen & Nurminen|||Injection site erythema||4.0|-5.9|0.696
73947515|NCT03239873|147427380|OTHER||Difference in Percentage|0.7||||0.796|TWO_SIDED|95.0|-4.7|6.2|||Miettinen & Nurminen|||Injection site pain||6.2|-4.7|0.796
73947516|NCT03239873|147427380|OTHER||Difference in Percentage|-2.7||||0.111||95.0|-6.2|0.7|||Miettinen & Nurminen|||Injection site swelling||0.7|-6.2|0.111
73947517|NCT03239873|147427381|OTHER||Difference in Percentage|-0.3||||0.931|TWO_SIDED|95.0|-6.9|6.4|||Miettinen & Nurminen|||Injection site erythema||6.4|-6.9|0.931
73947518|NCT03239873|147427381|OTHER||Difference in Percentage|-1.6||||0.523|TWO_SIDED|95.0|-6.6|3.4|||Miettinen & Nurminen|||Injection site pain||3.4|-6.6|0.523
73947519|NCT03239873|147427381|OTHER||Difference in Percentage|2.0||||0.415|TWO_SIDED|95.0|-2.9|6.9|||Miettinen & Nurminen|||Injection site swelling||6.9|-2.9|0.415
73947520|NCT03239873|147427382|OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-3.4|6.7|||||Miettinen \& Nurminen|||6.7|-3.4|
73947521|NCT03239873|147427383|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.5|2.6|||||Miettinen \& Nurminen|||2.6|-2.5|
73947522|NCT03239873|147427384|OTHER||Difference in Percentage|1.9|||||TWO_SIDED|95.0|-6.1|9.8|||||Miettinen \& Nurminen|||9.8|-6.1|
73947523|NCT03239873|147427385|OTHER||Difference in Percentage|2.3|||||TWO_SIDED|95.0|-4.7|9.2|||||Miettinen \& Nurminen|||9.2|-4.7|
73947524|NCT03239873|147427390|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Miettinen \& Nurminen|||1.3|-1.3|
73976629|NCT00357994|147499325|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.08|STANDARD_ERROR_OF_MEAN|0.45||0.8574|TWO_SIDED|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.82|-0.98|0.8574
73976630|NCT00357994|147499326|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-10.4|STANDARD_ERROR_OF_MEAN|4.3||0.0184|TWO_SIDED|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-1.8|-19.1|0.0184
73976631|NCT00357994|147499327|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-11.6|STANDARD_ERROR_OF_MEAN|4.5||0.0129|TWO_SIDED|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-2.5|-20.6|0.0129
73976632|NCT00357994|147499328|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-2.2|STANDARD_ERROR_OF_MEAN|3.4||0.5246|TWO_SIDED|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.6|-9.0|0.5246
73976633|NCT00357994|147499329|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.2423|TWO_SIDED|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||3.1|-12.0|0.2423
73947525|NCT03239873|147427391|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Miettinen \& Nurminen|||1.3|-1.3|
73947526|NCT03239873|147427394|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-4.6|10.3|||||Miettinen and Nurminen|||10.3|-4.6|
73947527|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Univariate analysis.||||||0.0000
73947528|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0.1038|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Multivariate analysis (6 main effects only).||||||0.1038
73947529|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0.0588|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Univariate analysis.||||||0.0588
73976634|NCT00357994|147499330|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.8|STANDARD_ERROR_OF_MEAN|3.1||0.2243|TWO_SIDED|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.4|-9.9|0.2243
73976635|NCT00357994|147499331|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.0|STANDARD_ERROR_OF_MEAN|3.4||0.2407|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.8|-10.8|0.2407
73976636|NCT00357994|147499332|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-13.8|STANDARD_ERROR_OF_MEAN|3.5||0.0002|TWO_SIDED|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-6.8|-20.8|0.0002
73976637|NCT00357994|147499333|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.3|STANDARD_ERROR_OF_MEAN|5.1||0.5213|TWO_SIDED|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||6.9|-13.6|0.5213
73976638|NCT00357994|147499334|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3741|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.9|-0.4|0.3741
73976639|NCT00357994|147499335|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0361|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-0.1|-2.4|0.0361
73976640|NCT00357994|147499336|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3578|TWO_SIDED|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.4|-1.1|0.3578
73947530|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0.4802|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Multivariate analysis (6 main effects only).||||||0.4802
73947531|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0.0147|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).||||||0.0147
73947532|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0.1181|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).||||||0.1181
73947533|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Univariate analysis.||||||0.0000
73947534|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Multivariate analysis (6 main effects only).||||||0.0006
73947535|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Univariate analysis.||||||0.0004
73947536|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0.3371|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Multivariate analysis (6 main effects only).||||||0.3371
73947537|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Univariate analysis.||||||0.0000
73947538|NCT01250119|147427407|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Multivariate analysis (6 main effects only).||||||0.0001
73947539|NCT02670538|147427416|SUPERIORITY||Least Squares (LS) Mean Difference|-2.5||||0.0417|TWO_SIDED|95.0|-4.6|-0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||-0.4|-4.6|0.0417
73947540|NCT02670538|147427416|SUPERIORITY||LS Mean Difference|-1.8||||0.1051|TWO_SIDED|95.0|-3.9|0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||0.4|-3.9|0.1051
73947541|NCT02670538|147427417|SUPERIORITY||LS Mean Difference|-0.3||||0.0417|TWO_SIDED|95.0|-0.6|-0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||-0.1|-0.6|0.0417
73947542|NCT02670538|147427417|SUPERIORITY||LS Mean Difference|-0.2||||0.137|TWO_SIDED|95.0|-0.4|0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||0.1|-0.4|0.1370
73947543|NCT02887989|147427421|SUPERIORITY|||||||0.657|||||||t-test, 2 sided|||||||.6570
73947544|NCT02887989|147427422|SUPERIORITY|||||||0.6339|||||||t-test, 2 sided|||||||.6339
73947545|NCT01641926|147427483|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|1.6|||||TWO_SIDED|95.0|-8.4|11.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (hepatitis B Virus \[HBV\] genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||11.6|-8.4|
73947546|NCT01641926|147427484|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-3.0|||||TWO_SIDED|95.0|-20.2|14.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||14.3|-20.2|
73947547|NCT01641926|147427485|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.6|||||TWO_SIDED|95.0|-7.2|12.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||12.3|-7.2|
73947548|NCT01641926|147427486|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.1|||||TWO_SIDED|95.0|-9.5|13.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||13.6|-9.5|
73947549|NCT01641926|147427486|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|10.1|||||TWO_SIDED|95.0|-7.2|27.1||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||27.1|-7.2|
73947550|NCT01641926|147427487|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.9|||||TWO_SIDED|95.0|-7.4|9.2||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||9.2|-7.4|
73976641|NCT00357994|147499337|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.5|STANDARD_ERROR_OF_MEAN|2.9||0.6088|TWO_SIDED|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.4|-7.4|0.6088
73976642|NCT00357994|147499338|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|11.4|STANDARD_ERROR_OF_MEAN|3.7||0.0033|TWO_SIDED|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||18.9|4.0|0.0033
73976643|NCT01079806|147499346|SUPERIORITY||Difference estimate|20.2||||0.0049|TWO_SIDED|95.0|9.1|31.4|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||31.4|9.1|0.0049
74089270|NCT02697773|147731611|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1066|TWO_SIDED|95.0|0.93|2.03|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.03|0.93|0.1066
73976644|NCT01079806|147499347|SUPERIORITY||Difference estimate|41.8|||<|0.0001|TWO_SIDED|95.0|29.4|54.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||54.2|29.4|<0.0001
73976645|NCT01079806|147499348|SUPERIORITY||Difference estimate|45.2|||<|0.0001||95.0|29.2|61.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||61.2|29.2|<0.0001
73976646|NCT01079806|147499349|SUPERIORITY||Difference estimate|38.2|||<|0.0001|TWO_SIDED|95.0|25.9|50.5|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||50.5|25.9|<0.0001
73947551|NCT02294630|147427490|OTHER|||||||0.399|||||||t-test, 2 sided|||||||0.399
73947552|NCT02567825|147427510|SUPERIORITY||Risk Ratio (RR)|0.97||||0.66|TWO_SIDED|95.0|0.84|1.12|||Generalized linear model|The p-value is adjusted for site, age at enrollment, and exposure or nonexposure to other children.|The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2-year follow-up period.||1.12|0.84|0.66
73947553|NCT02567825|147427511|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.67|1.01|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2 year follow-up among children considered at low risk of AOM recurrences at enrollment..||1.01|0.67|
73947554|NCT02567825|147427511|SUPERIORITY||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.86|1.33|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2 year follow-up among children considered at high risk of AOM recurrences at enrollment.||1.33|0.86|
73947555|NCT02567825|147427511|OTHER|||||||0.08|||||||Generalized linear models|||Null hypothesis: There is no interaction between comparison group (Surgical Management, Non-Surgical Management) and risk group (children considered at low risk of AOM recurrences at enrollment, children considered at high risk of AOM recurrences at enrollment).||||0.08
73947556|NCT02567825|147427512|SUPERIORITY|||||||0.48|||||||Chi-squared|||"Null hypothesis: There is no difference between the two groups in the proportion of children completing the study with 0, 1 or 2, 3 or 4, greater than or equal to 5 episodes of AOM.~."||||0.48
73976647|NCT01079806|147499350|SUPERIORITY||Difference estimate|12.1||||0.11|TWO_SIDED|95.0|-1.5|25.7|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||25.7|-1.5|0.11
73976648|NCT03732807|147499361|SUPERIORITY||Estimate of difference|29.11|||<|1e-06|TWO_SIDED|95.0|21.17|37.91|||Miettinen and Nurminen method|||||37.91|21.17|<0.000001
73976649|NCT03732807|147499361|SUPERIORITY||Estimate of difference|20.78|||<|1e-06|TWO_SIDED|95.0|13.65|29.18|||Miettinen and Nurminen method|||||29.18|13.65|<0.000001
73947557|NCT02567825|147427513|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.58|0.92|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children experiencing treatment failure.||0.92|0.58|
73976650|NCT03732807|147499361|SUPERIORITY||Estimate of difference|21.85|||<|1e-06|TWO_SIDED|95.0|14.65|30.23|||Miettinen and Nurminen method|||||30.23|14.65|<0.000001
73947558|NCT02567825|147427514|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.52|0.9|||||The Surgical Management group represents the numerator for the hazard ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the time to the first episode of AOM.||0.90|0.52|
73947559|NCT02567825|147427515|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.76|1.09|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of episodes categorized as probably severe.||1.09|0.76|
73947560|NCT02567825|147427516|SUPERIORITY||Risk Ratio (RR)|0.34|||||TWO_SIDED|95.0|0.26|0.44||||||Null hypothesis: There is no difference between the two groups in the proportion of episodes presenting with tympanic membrane bulging rather than otorrhea|The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|0.44|0.26|
73947561|NCT02567825|147427517|SUPERIORITY||Difference of least-squares means|5.21|||||TWO_SIDED|95.0|2.6|7.82|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children experience tube otorrhea. The analysis uses a weighted regression model with weights equal to the length of follow-up.||7.82|2.60|
73947562|NCT02567825|147427518|SUPERIORITY||Difference of least-squares means|-6.32|||||TWO_SIDED|95.0|-7.55|-5.1|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children experience AOM symptoms with an intact TM. The analysis uses a weighted regression model with weights equal to the length of follow-up.||-5.10|-7.55|
73947563|NCT02567825|147427519|SUPERIORITY||Difference of least-squares means|-4.5|||||TWO_SIDED|95.0|-6.82|-2.18|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children receive systemic antimicrobials for AOM. The analysis uses a weighted regression model with weights equal to the length of follow-up.||-2.18|-6.82|
73947564|NCT02567825|147427520|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||The Surgical Management group represents the numerator for the hazard ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom PDD was reported.||1.03|0.44|
73947565|NCT02567825|147427521|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.51|1.22|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom diaper dermatitis was reported.||1.22|0.51|
73947566|NCT02567825|147427522|SUPERIORITY||Risk Ratio (RR)|2.57|||||TWO_SIDED|95.0|1.91|3.48|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom tube otorrhea was reported.||3.48|1.91|
73947567|NCT02567825|147427523|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.74|1.24|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children with no pathogens at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.24|0.74|
73947568|NCT02567825|147427523|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.83|1.72|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children positive only for at least 1 penicillin-susceptible pathogen at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.72|0.83|
73947569|NCT02567825|147427523|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.94|1.29|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children positive for at least 1 penicillin nonsusceptible pathogen at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.29|0.94|
73947570|NCT02567825|147427524|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.84|1.55|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of episodes of AOM at which a nonsusceptible pathogen is recovered.||1.55|0.84|
73947571|NCT02567825|147427525|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.84|1.41|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of routine non-illness visits at which a nonsusceptible pathogen is recovered.||1.41|0.84|
73947572|NCT02567825|147427526|SUPERIORITY|The analysis was ITT. The participants are randomized children with at least one episode of AOM late during the respiratory season at which a nasopharyngeal or throat culture is obtained.|Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.69|1.95|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|||1.95|0.69|
73976651|NCT03732807|147499361|SUPERIORITY||Estimate of difference|12.75||||0.000154|TWO_SIDED|95.0|6.69|20.36|||Miettinen and Nurminen method|||||20.36|6.69|0.000154
73976652|NCT03732807|147499362|SUPERIORITY||Estimate of difference|19.75|||<|1e-06|TWO_SIDED|95.0|11.91|27.59|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||27.59|11.91|<0.000001
73976653|NCT03732807|147499362|SUPERIORITY||Estimate of difference|11.33||||0.000526||95.0|4.93|17.74|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||17.74|4.93|0.000526
73976654|NCT03732807|147499362|SUPERIORITY||Estimate of difference|11.88||||0.000311||95.0|5.42|18.33|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||18.33|5.42|0.000311
73976655|NCT03732807|147499362|SUPERIORITY||Estimate of difference|9.09||||0.002922||95.0|3.1|15.07|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||15.07|3.10|0.002922
73976656|NCT03732807|147499363|SUPERIORITY||Estimate of difference|20.24|||<|1e-06||95.0|13.23|28.49|||Miettinen and Nurminen method|||||28.49|13.23|<0.000001
73976657|NCT03732807|147499363|SUPERIORITY||Estimate of difference|11.68||||0.000337||95.0|5.82|19.07|||Miettinen and Nurminen method|||||19.07|5.82|0.000337
73976658|NCT03732807|147499363|SUPERIORITY||Estimate of difference|12.17||||0.000228||95.0|6.27|19.53|||Miettinen and Nurminen method|||||19.53|6.27|0.000228
73976659|NCT03732807|147499363|SUPERIORITY||Estimate of difference|9.39||||0.001875|TWO_SIDED|95.0|3.86|16.46|||Miettinen and Nurminen method|||||16.46|3.86|0.001875
73976660|NCT03732807|147499364|SUPERIORITY||Estimate of difference|42.96|||<|1e-06|TWO_SIDED|95.0|31.68|54.25|||Miettinen and Nurminen method|||||54.25|31.68|<0.000001
73976661|NCT03732807|147499364|SUPERIORITY||Estimate of difference|36.18|||<|1e-06|TWO_SIDED|95.0|25.22|47.14|||Miettinen and Nurminen method|||||47.14|25.22|<0.000001
73976662|NCT03732807|147499364|SUPERIORITY||Estimate of difference|39.96|||<|1e-06|TWO_SIDED|95.0|28.85|51.06|||Miettinen and Nurminen method|||||51.06|28.85|<0.000001
73976663|NCT03732807|147499364|SUPERIORITY||Estimate of difference|32.72|||<|1e-06|TWO_SIDED|95.0|21.95|43.5|||Miettinen and Nurminen method|||||43.50|21.95|<0.000001
73976664|NCT00734578|147499425|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-4.5||||0.002||95.0|-7.5|-1.4||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.||-1.4|-7.5|0.002
73976665|NCT00734578|147499425|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-5.3|||<|0.001||95.0|-8.3|-2.3||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.||-2.3|-8.3|<0.001
74032092|NCT02749721|147617308|OTHER||F statistic|0.001||||0.966|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.966
73947573|NCT02567825|147427527|SUPERIORITY||Difference of least-squares means|0.25|||||TWO_SIDED|95.0|-0.06|0.56|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean parental satisfaction score||0.56|-0.06|
73976666|NCT00734578|147499426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.024
73976667|NCT00734578|147499426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.003
73976668|NCT00734578|147499427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.013
73976669|NCT00734578|147499427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
73976670|NCT00734578|147499428|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-1.7||||0.019||95.0|-3.2|-0.3||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.3|-3.2|0.019
73976671|NCT00734578|147499428|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.6|||<|0.001||95.0|-4.0|-1.1||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.1|-4.0|<0.001
73870350|NCT02218008|147284483|SUPERIORITY|Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Least Squares Mean Difference|-1.9||||0.026|TWO_SIDED|95.0|-3.6|-0.2||ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Mixed Models Analysis||Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.||-0.2|-3.6|0.026
73870351|NCT02218008|147284484|SUPERIORITY|The primary hypotheses were evaluated using a 6-step, fixed sequence approach to adjust for multiple comparisons. Using this method, hypothesis testing (using alpha=0.05) continued through the sequence until statistical significance was not achieved. Steps 1-3 included testing the ALKS 5461 2mg/2mg dose vs placebo for the 3 primary endpoints.|Least Squares Mean Difference|-1.7||||0.076|TWO_SIDED|95.0|-3.6|0.2||ALKS 5461 is compared to placebo within each of the 2 stages, and resulting treatment effects from each stage are combined for a single hypothesis test using equal weights of 0.5 for both stages.|Mixed Models Analysis|||ALKS 5461 is compared to placebo within each of the 2 stages (i.e., ALKS 5461 2/2 S1 vs Placebo S1; and ALKS 5461 2/2 S2 vs Placebo S2). Efficacy was estimated as a weighted average across 2 stages using equal weights.||0.2|-3.6|0.076
73870352|NCT02038075|147284488|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.38||||0.02|TWO_SIDED|95.0|0.16|0.87|||Regression, Cox|||To determine the effectiveness of brief CBT compared with treatment as usual, univariate and multivariate Cox proportional hazard regression models were used to analyze time to the first suicide attempt. Time to suicide attempt was measured by calculating the total number of days from enrollment to the first suicide attempt. For participants without a suicide attempt, the total number of days from enrollment to the last assessment was calculated.||.87|.16|.02
73870353|NCT02519595|147284541|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.2
73947574|NCT02567825|147427528|SUPERIORITY||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.98|1.18|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating at least one health care encounter since the previous study visit.||1.18|0.98|
73947575|NCT02567825|147427529|SUPERIORITY|Reports for which the parent did not answer the question were excluded from the analysis.|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.88|1.41|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating a parent missed work due to child's illness.||1.41|0.88|
73947576|NCT02567825|147427530|SUPERIORITY|Reports indicating the parent did not answer the question were excluded from the analysis.|Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.89|1.48|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating the need for special childcare arrangements due to child's illness.||1.48|0.89|
73870354|NCT02519595|147284542|SUPERIORITY_OR_OTHER|||||||0.09|||||||Kruskal-Wallis|||||||0.09
73870355|NCT02519595|147284543|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.2
73870356|NCT02519595|147284545|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared|||Adverse events in ED||||0.8
73870357|NCT02519595|147284545|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||Post discharge Emesis||||0.5
73870358|NCT02519595|147284546|SUPERIORITY_OR_OTHER|||||||0.011|||||||Chi-squared|||||||0.011
73870359|NCT00387036|147284547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.37||||90.0|-1.59|-0.25||||||||-0.25|-1.59|
73870360|NCT00387036|147284548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.17|STANDARD_ERROR_OF_MEAN|1.9||||90.0|-0.28|6.61||||||||6.61|-0.28|
73870361|NCT03188510|147284550|OTHER||Ratio of geometric least squares means|0.971|||||TWO_SIDED|90.0|0.805|1.17||||||||1.17|0.805|
73870362|NCT03188510|147284550|OTHER||Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.841|1.22||||||||1.22|0.841|
73870363|NCT03188510|147284550|OTHER||Ratio of geometric least squares means|0.985|||||TWO_SIDED|90.0|0.819|1.18||||||||1.18|0.819|
73870364|NCT03188510|147284551|OTHER||Ratio of geometric least squares means|0.978|||||TWO_SIDED|90.0|0.811|1.18||||||||1.18|0.811|
73870365|NCT03188510|147284551|OTHER||Ratio of geometric least squares means|1.0|||||TWO_SIDED|90.0|0.833|1.21||||||||1.21|0.833|
73870366|NCT03188510|147284551|OTHER||Ratio of geometric least squares means|0.982|||||TWO_SIDED|90.0|0.817|1.18||||||||1.18|0.817|
73870367|NCT03139344|147284553|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73947577|NCT02567825|147427531|SUPERIORITY||Difference of least-square means|-0.05|||||TWO_SIDED|95.0|-0.13|0.02|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean OM-6 survey score||0.02|-0.13|
73947578|NCT02567825|147427531|SUPERIORITY||Difference of least-square means|0.06|||||TWO_SIDED|95.0|-0.13|0.24|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean OM-6 survey--children's overall QOL score.||0.24|-0.13|
73947579|NCT02567825|147427532|SUPERIORITY||Difference of least-square means|-0.04|||||TWO_SIDED|95.0|-1.55|1.47|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean caregiver impact questionnaire score.||1.47|-1.55|
73947580|NCT02567825|147427532|SUPERIORITY||Difference of least-square means|0.03|||||TWO_SIDED|95.0|-0.14|0.2|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean caregiver impact questionnaire--caregiver's overall QOL score.||0.20|-0.14|
73947581|NCT03349268|147427550|SUPERIORITY|||||||0.23|||||||Poisson regression|||||||0.23
73947582|NCT02307513|147427573|SUPERIORITY||Difference in LS Mean|-92.6|||<|0.0001|TWO_SIDED|95.0|-130.59|-54.6|||ANCOVA|ANCOVA model with AUC W0-12 as the response variables; treatment arm, sex, region as factors and the number of oral ulcers at baseline as a covariate.|Treatment difference = Apremilast - Placebo|The AUC W0-12 for oral ulcer counts was compared between the placebo treatment group and the apremilast 30 BID treatment group using a 2-tailed parametric analysis of covariance (ANCOVA) test at the 0.05 significance level.||-54.60|-130.59|<0.0001
73947583|NCT02307513|147427574|SUPERIORITY||Difference in LS Mean|-24.8|||<|0.0001|TWO_SIDED|95.0|-32.8|-16.8|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-16.8|-32.8|<0.0001
73976672|NCT00734578|147499429|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.4||||0.002||95.0|-4.0|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.9|-4.0|0.002
73976673|NCT00734578|147499429|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-3.0|||<|0.001||95.0|-4.5|-1.5||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.5|-4.5|<0.001
73976674|NCT00734578|147499430|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
73976675|NCT00734578|147499430|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
73976676|NCT00734578|147499431|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.4||||0.001||95.0|-3.9|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.9|-3.9|0.001
73976677|NCT00734578|147499431|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.2||||0.003||95.0|-3.6|-0.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.7|-3.6|0.003
73976678|NCT00734578|147499432|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-5.1|||<|0.001||95.0|-8.0|-2.2||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-2.2|-8.0|<0.001
74032093|NCT02749721|147617308|OTHER||F statistic|4.121||||0.048|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.048
74089271|NCT02697773|147731611|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0154|TWO_SIDED|95.0|1.1|2.54|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.54|1.10|0.0154
73870368|NCT03139344|147284553|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73870369|NCT03139344|147284554|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73947584|NCT02307513|147427575|SUPERIORITY||Difference in LS Mean|-11.94|||<|0.0001|TWO_SIDED|95.0|-16.2|-7.67|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-7.67|-16.20|<0.0001
73947585|NCT02307513|147427576|SUPERIORITY||Difference in LS Means|-0.5||||0.0335|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.0|-1.0|0.0335
73947586|NCT02307513|147427577|SUPERIORITY||Difference in LS Means|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.6|-1.4|<0.0001
73947587|NCT02307513|147427578|SUPERIORITY||Difference in LS Means|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.5|-1.3|<0.0001
73947588|NCT02307513|147427579|SUPERIORITY||Adjusted difference in percentages|25.1|||<|0.0001|TWO_SIDED|95.0|15.5|34.6|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||34.6|15.5|<0.0001
73976679|NCT00734578|147499432|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-4.7||||0.002||95.0|-7.6|-1.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.7|-7.6|0.002
73976680|NCT00734578|147499433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.971||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.971
73976681|NCT00734578|147499433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.502||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.502
73976682|NCT03274076|147499439|SUPERIORITY||Rate ratio|1.25|||||TWO_SIDED|90.0|0.19|8.33|||||Tofacitinib represents the numerator, and placebo represents the denominator.|H0: Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Tofacitinib.||8.33|0.19|
73976683|NCT03274076|147499440|SUPERIORITY||Rate ratio|0.65|||||TWO_SIDED|90.0|0.25|1.71|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Tofacitinib||1.71|0.25|
73947589|NCT02307513|147427580|SUPERIORITY||Hazard Ratio (HR)|2.4|||<|0.0001|TWO_SIDED|95.0|1.692|3.405|||Stratified Log-Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors.|||3.405|1.692|<0.0001
73947590|NCT02307513|147427581|SUPERIORITY||Adjusted difference in percentages|30.6|||<|0.0001|TWO_SIDED|95.0|18.1|43.1|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||43.1|18.1|<0.0001
73947591|NCT02307513|147427582|SUPERIORITY||Difference in LS Mean|-3.0||||0.0003|TWO_SIDED|95.0|-4.5|-1.4|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-1.4|-4.5|0.0003
73947592|NCT02307513|147427583|SUPERIORITY||Adjusted difference in percentages|28.4||||0.11|TWO_SIDED|95.0|-3.6|60.4|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex.|Adjusted difference was the weighted average of the treatment differences across the 2 strata of sex with the CMH weights.|||60.4|-3.6|0.1100
73947593|NCT02307513|147427584|SUPERIORITY||Adjusted difference in percentages|17.5||||0.0204|TWO_SIDED|95.0|4.2|30.7|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test, adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||30.7|4.2|0.0204
73947594|NCT02307513|147427585|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.0112|TWO_SIDED|95.0|0.408|0.915|||Stratified Log Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors|||0.915|0.408|0.0112
73947595|NCT02307513|147427586|SUPERIORITY||Difference in LS Means|-0.4||||0.0683|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|ANCOVA model with treatment group, sex and region as factors and the baseline ulcers number as a covariate.||||0.0|-0.9|0.0683
73947596|NCT02307513|147427587|SUPERIORITY||Difference in LS Mean|-0.1||||0.5944|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.||||0.3|-0.4|0.5944
73947597|NCT02307513|147427588|SUPERIORITY||Difference in LS Mean|-5.5||||0.6182|TWO_SIDED|95.0|-27.6|16.7|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.||||16.7|-27.6|0.6182
73947598|NCT01121172|147427594|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Non parametric test||||||0.001
73947599|NCT01121172|147427595|SUPERIORITY_OR_OTHER|||||||0.232|||||||Chi-squared|Chi-square test of frequency distribution amng obese study group and HapMap-CEU polymorphism distribution||||||0.232
73947600|NCT03500640|147427615|SUPERIORITY|||||||0.196||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.196
73870370|NCT03139344|147284554|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73947601|NCT03500640|147427616|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.800
73947602|NCT03500640|147427617|SUPERIORITY|||||||0.677|||||||t-test, 2 sided|||||||0.677
73947603|NCT03500640|147427618|SUPERIORITY|||||||0.349||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.349
73947604|NCT03500640|147427619|SUPERIORITY|||||||0.891|||||||t-test, 2 sided|||||||0.891
73947605|NCT03500640|147427620|SUPERIORITY|||||||0.14||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.140
73947606|NCT03500640|147427621|SUPERIORITY|||||||0.732|||||||t-test, 2 sided|||||||0.732
73947607|NCT03500640|147427622|SUPERIORITY|||||||0.637||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.637
73947608|NCT03500640|147427623|SUPERIORITY|||||||0.521||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.521
73947609|NCT03500640|147427624|SUPERIORITY|||||||0.083||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.083
73947610|NCT03500640|147427625|SUPERIORITY|||||||0.778||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.778
73947611|NCT03500640|147427626|SUPERIORITY|||||||0.982||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.982
73947612|NCT03500640|147427627|SUPERIORITY|||||||0.081||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.081
73947613|NCT03500640|147427628|SUPERIORITY|||||||0.712||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.712
73947614|NCT03500640|147427629|SUPERIORITY|||||||0.371||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.371
73947615|NCT03500640|147427630|SUPERIORITY|||||||0.801||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.801
73947616|NCT03500640|147427631|SUPERIORITY|||||||0.069||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.069
73947617|NCT03500640|147427632|SUPERIORITY|||||||0.193||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.193
73947618|NCT03500640|147427633|SUPERIORITY|||||||0.197||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.197
73947619|NCT03500640|147427634|SUPERIORITY|||||||0.594||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.594
73947620|NCT03500640|147427635|SUPERIORITY|||||||0.328|||||||t-test, 2 sided|||||||0.328
73947621|NCT03500640|147427636|SUPERIORITY|||||||0.398||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.398
73947622|NCT03500640|147427637|SUPERIORITY|||||||0.288||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.288
73947623|NCT03500640|147427638|SUPERIORITY|||||||0.592||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.592
73947624|NCT03500640|147427639|SUPERIORITY|||||||0.805||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.805
73947625|NCT03500640|147427640|SUPERIORITY|||||||0.421||||||The a priori threshold for significance is 0.05|t-test, 2 sided|||The p value provided here is for the physical component summary score (PCS) only||||0.421
73947626|NCT03500640|147427641|SUPERIORITY|The p value provided here is for the physical component summary score (PCS) only||||||0.16|||||||t-test, 2 sided|||||||0.160
73947627|NCT03500640|147427642|SUPERIORITY|||||||0.196||||||The a priori threshold for significance is 0.05|t-test, 2 sided|||||||0.196
73947628|NCT03500640|147427643|SUPERIORITY|||||||0.532||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.532
73947629|NCT01508013|147427653|SUPERIORITY_OR_OTHER|||||||0.633|||||||Mixed Models Analysis|||||||.633
73976684|NCT03274076|147499440|SUPERIORITY||Rate ratio|0.53|||||TWO_SIDED|90.0|0.26|1.07|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Tofacitinib||1.07|0.26|
73976685|NCT03274076|147499440|SUPERIORITY||Rate ratio|0.85|||||TWO_SIDED|90.0|0.49|1.49|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Tofacitinib||1.49|0.49|
73976686|NCT03274076|147499440|SUPERIORITY||Rate ratio|0.89|||||TWO_SIDED|90.0|0.52|1.52|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Tofacitinib||1.52|0.52|
73976687|NCT03274076|147499441|SUPERIORITY||Rate ratio|3.85|||||TWO_SIDED|90.0|0.68|21.77|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 36 in Placebo = Rate of adverse events of special interest throughout week 36 in Tofacitinib||21.77|0.68|
73976688|NCT03274076|147499441|SUPERIORITY||Rate ratio|1.87|||||TWO_SIDED|90.0|0.5169|6.7652|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 48 in Placebo = Rate of adverse events of special interest throughout week 48 in Tofacitinib||6.7652|0.5169|
73976689|NCT03274076|147499442|SUPERIORITY|||||||0.1978|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 12 in placebo = The absolute change in mRSS from week 0 to week 12 in Tofacitinib.||||0.1978
73976690|NCT03274076|147499442|SUPERIORITY|||||||0.4665|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 24 in placebo = The absolute change in mRSS from week 0 to week 24 in Tofacitinib.||||0.4665
73976691|NCT03274076|147499442|SUPERIORITY|||||||0.3063|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 36 in placebo = The absolute change in mRSS from week 0 to week 36 in Tofacitinib.||||0.3063
73976692|NCT03274076|147499442|SUPERIORITY|||||||0.6|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 48 in placebo = The absolute change in mRSS from week 0 to week 48 in Tofacitinib.||||0.6000
73976693|NCT03274076|147499443|SUPERIORITY|||||||0.4535|||||||Exact Wilcoxon|||H0: The CRISS score at week 12 in placebo = The CRISS score at week 12 in Tofacitinib.||||0.4535
73870371|NCT03139344|147284555|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
73870372|NCT03139344|147284555|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73947630|NCT01508013|147427654|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||.001
73947631|NCT01508013|147427655|SUPERIORITY_OR_OTHER|||||||0.018|||||||Mixed Models Analysis|||||||.018
73947632|NCT01279343|147427693|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.03|TWO_SIDED|95.0|-5.9|-0.3|||t-test, 2 sided|||||-0.3|-5.9|0.03
73947633|NCT01279343|147427694|SUPERIORITY||Risk Ratio (RR)|0.99||||0.96|TWO_SIDED|95.0|0.8|1.23|||Chi-squared|||Comparison of vaginal delivery between groups.||1.23|.80|0.96
73947634|NCT01279343|147427694|SUPERIORITY||Risk Ratio (RR)|1.03||||0.9|TWO_SIDED|95.0|0.57|1.9|||Chi-squared|||Cesarean deliveries were compared between the groups.||1.90|0.57|0.90
73947635|NCT04534114|147427703|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.94||||0.944|TWO_SIDED|95.0|0.19|4.68|||Log Rank|||||4.68|0.19|0.944
73947636|NCT04534114|147427703|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.95||||0.953|TWO_SIDED|95.0|0.19|4.72|||Log Rank|||||4.72|0.19|0.953
73947637|NCT04534114|147427703|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.63||||0.605|TWO_SIDED|95.0|0.1|3.75|||Log Rank|||||3.75|0.10|0.605
73976694|NCT03274076|147499443|SUPERIORITY|||||||0.8392|||||||Exact Wilcoxon|||H0: The CRISS score at week 24 in placebo = The CRISS score at week 24 in Tofacitinib.||||0.8392
73976695|NCT03274076|147499443|SUPERIORITY|||||||0.9212|||||||Exact Wilcoxon|||H0: The CRISS score at week 48 in placebo = The CRISS score at week 48 in Tofacitinib.||||0.9212
73976696|NCT00975585|147499444|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|97.46|-0.058|0.031|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis is adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have non-inferior (less than or equal to) average corneal staining than lotrafilcon B after two weeks of wear.||0.031|-0.058|
73976697|NCT00975585|147499445|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.25|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|97.46|-0.021|-0.01|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior (less than or equal to)in visual acuity to lotrafilcon B contact lenses after two weeks of wear.||-0.010|-0.021|
73976698|NCT00975585|147499446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.127|||TWO_SIDED|97.46|0.117|0.402|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have a higher rating of overall comfort than lotrafilcon B after two weeks of wear.||0.402|0.117|
73976699|NCT00975585|147499447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|97.46|-0.218|0.098|||Mixed Models Analysis||The mean difference is lotrafilcon B at 2 weeks minus lotrafilcon B at 4 weeks. Analysis adjusted for duration of wear, stie, duration of wear by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that lotrafilcon B contact lenses have a lower rating of overall comfort after 4 weeks of wear compared to after 2 weeks of wear.||0.098|-0.218|
73976700|NCT00975585|147499448|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.123|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|98.2|-0.123|-0.051|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in limbal redness 5 to lotrafilcon B contact lenses after two weeks of wear.||-0.051|-0.123|
73976701|NCT00975585|147499449|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|98.2|-0.068|0.008|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in bulbar redness to lotrafilcon B contact lenses after two weeks of wear.||0.008|-0.068|
73976702|NCT00975585|147499450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.411|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|98.2|-0.411|-0.117|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by stie interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have less frequency of dryness than lotrafilcon B contact lenes after two weeks of wear.||-0.117|-0.411|
74032094|NCT02749721|147617308|OTHER||F statistic|8.573||||0.005|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.005
73976703|NCT00683800|147499451|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.89|||<|0.001|TWO_SIDED|95.0|-3.8|-1.98|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-1.98|-3.80|<0.001
73976704|NCT00683800|147499452|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.79|||<|0.001|TWO_SIDED|95.0|-3.77|-1.82|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-1.82|-3.77|<0.001
73976705|NCT00683800|147499453|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.4|-0.16|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-0.16|-0.40|<0.001
73976706|NCT00683800|147499454|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-0.18|-0.44|<0.001
73976707|NCT00683800|147499455|SUPERIORITY_OR_OTHER||Wald Formula|-1.07|||||TWO_SIDED|90.0|-2.86|0.72|||||The 90% CI for excess risk was obtained using the Wald Formula.|Excess risk of DVS SR 100 mg over placebo per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||0.72|-2.86|
73976708|NCT00683800|147499456|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving a response as defined by minimal clinically important difference (MCID) at week 12 was compared between DVS and placebo treatment groups with a Cochran-Mantel-Haenszel test.||||<0.001
74032095|NCT02749721|147617308|OTHER||F statistic|2.823||||0.101|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.101
74032096|NCT02749721|147617308|OTHER||F statistic|0.806||||0.373|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.373
74032097|NCT02749721|147617308|OTHER||F statistic|1.822||||0.183|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.183
73947638|NCT04534114|147427704|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|1.45||||0.612|TWO_SIDED|95.0|0.34|6.08|||Log Rank|||||6.08|0.34|0.612
73947639|NCT04534114|147427704|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|1.27||||0.757|TWO_SIDED|95.0|0.28|5.66|||Log Rank|||||5.66|0.28|0.757
73947640|NCT04534114|147427704|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.91||||0.909|TWO_SIDED|95.0|0.18|4.52|||Log Rank|||||4.52|0.18|0.909
73947641|NCT03287414|147427711|SUPERIORITY||Least Squares Mean Difference|0.063|STANDARD_ERROR_OF_MEAN|0.1379||0.3248|TWO_SIDED|80.0|-0.115|0.241||1-sided p-values were obtained using MMRM Model.|MMRM|||||0.241|-0.115|0.3248
73947642|NCT03287414|147427712|OTHER|||||||0.868|||||||Log Rank|||||||0.868
73947643|NCT03287414|147427714|OTHER||Hazard Ratio (HR)|2.6||||0.921|TWO_SIDED|80.0|1.1|6.3|||Log Rank|||PFS1||6.3|1.1|0.921
73976709|NCT00683800|147499457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.47|||<|0.001|TWO_SIDED|95.0|2.24|5.36|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||5.36|2.24|<0.001
73976710|NCT00683800|147499457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67|||<|0.001|TWO_SIDED|95.0|1.75|4.1|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||4.10|1.75|<0.001
73976711|NCT00683800|147499458|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.39|||<|0.001|TWO_SIDED|95.0|2.47|7.81|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||7.81|2.47|<0.001
73976712|NCT00683800|147499458|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.96|5.09|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||5.09|1.96|<0.001
73976713|NCT00683800|147499459|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||A log-rank test was used to compare the treatment groups.||||<0.001
73976714|NCT00683800|147499460|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.04|||<|0.001|TWO_SIDED|95.0|-3.07|-1.0|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)||-1.00|-3.07|<0.001
73976715|NCT00683800|147499460|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.81|||<|0.001|TWO_SIDED|95.0|-4.12|-1.51|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)||-1.51|-4.12|<0.001
73947644|NCT03287414|147427714|OTHER||Hazard Ratio (HR)|2.2||||0.863|TWO_SIDED|80.0|0.9|5.6|||Log Rank|||PFS2||5.6|0.9|0.863
73947645|NCT03287414|147427715|OTHER||Hazard Ratio (HR)|2.2||||0.863|TWO_SIDED|80.0|0.9|5.6|||Log Rank|||FVC||5.6|0.9|0.863
73947646|NCT03287414|147427715|OTHER||Hazard Ratio (HR)|0.9||||0.457|TWO_SIDED|80.0|0.4|2.0|||Log Rank|||DLCO||2.0|0.4|0.457
73947647|NCT03287414|147427715|OTHER||Hazard Ratio (HR)|0.3||||0.019|TWO_SIDED|80.0|0.1|0.6|||Log Rank|||6MWD||0.6|0.1|0.019
73947648|NCT03287414|147427716|OTHER||Hazard Ratio (HR)|1.1||||0.611|TWO_SIDED|80.0|0.6|2.0|||Log Rank|||Composite Endpoint 1||2.0|0.6|0.611
73947649|NCT03287414|147427716|OTHER||Hazard Ratio (HR)|1.1||||0.549|TWO_SIDED|80.0|0.6|1.9|||Log Rank|||Composite Endpoint 2||1.9|0.6|0.549
73947650|NCT03287414|147427717|SUPERIORITY||Least Squares of the Mean|-0.92|STANDARD_ERROR_OF_MEAN|1.3109||0.7576|TWO_SIDED|80.0|-2.615|0.774||1-sided p-values were obtained using MMRM Model.|MMRM|||||0.774|-2.615|0.7576
73947651|NCT03287414|147427718|SUPERIORITY||Least Squares of the Mean|32.222|STANDARD_ERROR_OF_MEAN|61.8632||0.3018|TWO_SIDED|80.0|-47.572|112.015||1-sided p-values were obtained using MMRM Model.|MMRM|||||112.015|-47.572|0.3018
73947652|NCT03287414|147427719|SUPERIORITY||Least Squares of the Mean|29.166|STANDARD_ERROR_OF_MEAN|60.0143||0.314|TWO_SIDED|80.0|-48.22|106.553||1-sided p-values were obtained using MMRM Model.|MMRM|||||106.553|-48.220|0.3140
73947653|NCT03287414|147427720|SUPERIORITY||Least Squares of the mean|1.77|STANDARD_ERROR_OF_MEAN|1.5422||0.1269|TWO_SIDED|80.0|-0.219|3.759||1-sided p-values were obtained using MMRM Model.|MMRM|||||3.759|-0.219|0.1269
73947654|NCT03245255|147427733|OTHER|Correlation analysis|Pearson Correlation Coefficient|-0.8|STANDARD_DEVIATION|0.1|||TWO_SIDED|||||||||||||
73947655|NCT04765735|147427735|SUPERIORITY||||||<|0.001||||||"It is hypothesized that the proportion of subjects with a reduction in overstimulation sensation during CL compared to OL period exceeds a performance goal of 50%.~H0: p ≤ 50% HA: p \> 50%"|Binomial Exact Test|||||||<0.001
73947656|NCT01087996|147427745|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
73947657|NCT01087996|147427746|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANOVA|||||||0.75
73947658|NCT01087996|147427747|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
73947659|NCT01087996|147427748|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
73947660|NCT01087996|147427749|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
73947661|NCT01087996|147427750|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
73947662|NCT01087996|147427751|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Repeated measures ANOVA|||||||0.87
73947663|NCT01087996|147427752|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Repeated measures ANOVA|||||||0.84
73947664|NCT01087996|147427753|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Chi-squared|||||||0.55
73947665|NCT01008475|147427755|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.78|1.64||||||||1.64|0.78|
73947666|NCT01008475|147427755|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.77|1.61||||||||1.61|0.77|
73976716|NCT00683800|147499461|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31||||0.002|TWO_SIDED|95.0|-0.51|-0.12|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)||-0.12|-0.51|0.002
73976717|NCT00683800|147499461|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33||||0.003|TWO_SIDED|95.0|-0.54|-0.11|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)||-0.11|-0.54|0.003
73870373|NCT03139344|147284556|SUPERIORITY|||||||0.148|||||||ANOVA|||||||0.148
73947667|NCT01008475|147427756|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.54|1.28||||||||1.28|0.54|
73947668|NCT01008475|147427756|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|0.52|1.25||||||||1.25|0.52|
73947669|NCT01008475|147427757|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||||1.65|0.75|
73947670|NCT01008475|147427757|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||||1.65|0.75|
73947671|NCT01008475|147427759|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95|||||TWO_SIDED|95.0|0.67|1.34||||||||1.34|0.67|
73947672|NCT01008475|147427759|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.05|||||TWO_SIDED|95.0|0.74|1.48||||||||1.48|0.74|
73947673|NCT01022073|147427778|SUPERIORITY_OR_OTHER|||||||0.808|||||||t-test, 2 sided|This analysis is based on the completers. We are working on the imputation methods to account for the missing data and will revise results later.||||||0.808
73947674|NCT05067933|147427796|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.953|||||||Wilcoxon rank sum tests|||||||0.953
73947675|NCT05067933|147427797|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.5|||||||Wilcoxon rank sum tests|||||||0.500
73947676|NCT05067933|147427798|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.912|||||||Wilcoxon rank sum tests|||||||0.912
73947677|NCT05067933|147427799|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.678|||||||Wilcoxon rank sum tests|||||||0.678
73947678|NCT05067933|147427800|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.257|||||||Wilcoxon rank sum tests|||||||0.257
73947679|NCT05067933|147427801|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.748|||||||Wilcoxon rank sum tests|||||||0.748
73947680|NCT05067933|147427802|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.946|||||||Wilcoxon rank sum tests|||||||0.946
73947681|NCT05067933|147427805|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.356|||||||Wilcoxon rank sum tests|||||||0.356
73947682|NCT05067933|147427806|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.267|||||||Wilcoxon rank sum tests|||||||0.267
73947683|NCT01316770|147427820|SUPERIORITY|The standard deviation (SD) of the change in salivary flow was assumed to be 0.0168 for the placebo and 0.0906 for the dexamethasone parotid. The within-subject correlation between two glands was assumed to be 0.15. A total of 16 patients would be required to have 80% power to detect a one-sided 40% increase in dexamethasone-irrigated parotid glands compared with the saline irrigated parotid glands with respect to change in salivary flow from Day 0 to Day 56.||||||0.236||||||No corrections were made for multiple comparisons because there was only one primary hypothesis.|one-sided Paired t-test|||The mixed models analysis included all time points but it failed to converge. Therefore, an alternative analysis was performed using a paired t-test. Because the Satterthwaite correction \[that was specified in the statistical analysis plan (SAP) for the mixed model\] is not available for the paired t-test, it was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates, as these measures were appropriate for the model used.||||0.236
73947684|NCT01316770|147427821|SUPERIORITY|||||||0.662|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.662
73947685|NCT01316770|147427822|SUPERIORITY|||||||0.607|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.607
73947686|NCT01316770|147427823|SUPERIORITY|||||||0.586|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.586
73947687|NCT01316770|147427837|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||0.500
73947688|NCT01316770|147427837|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
73947689|NCT01316770|147427837|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||0.500
73947690|NCT01316770|147427837|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
73947691|NCT01316770|147427839|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
73947692|NCT01316770|147427839|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
73947693|NCT01316770|147427840|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
73947694|NCT01316770|147427840|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
73976718|NCT00683800|147499462|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.34|||<|0.001|TWO_SIDED|95.0|-3.05|-1.64|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.64|-3.05|<0.001
73976719|NCT00683800|147499462|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.51|-0.99|<0.001
73976720|NCT00683800|147499462|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.89|-0.45|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.45|-0.89|<0.001
73976721|NCT00683800|147499462|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05||||0.162|TWO_SIDED|95.0|-0.13|0.02|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.02|-0.13|0.162
74039478|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.35||0.0082|TWO_SIDED|95.0|-1.6|-0.24|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-1.60|0.0082
73870374|NCT03139344|147284556|SUPERIORITY|||||||0.005|||||||ANOVA|||||||0.005
73976722|NCT00683800|147499462|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.84|-1.0|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 was outcome variable, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.00|-1.84|<0.001
73947695|NCT01316770|147427840|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||1.000
73947696|NCT01316770|147427840|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
73947697|NCT01316770|147427843|OTHER|||||||0.25|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||0.250
73947698|NCT01316770|147427843|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
73947699|NCT01316770|147427843|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||1.000
73947700|NCT01316770|147427843|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
73947701|NCT01316770|147427844|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
73947702|NCT01316770|147427844|OTHER|||||||0.625|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||0.625
73976723|NCT00683800|147499462|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.22||||0.066|TWO_SIDED|95.0|-0.46|0.01|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.01|-0.46|0.066
73976724|NCT00683800|147499462|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.64|||<|0.001|TWO_SIDED|95.0|-0.79|-0.5|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.50|-0.79|<0.001
74032098|NCT02749721|147617308|OTHER||F statistic|0.516||||0.475|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.475
73947703|NCT01316770|147427844|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||0.5000
73947704|NCT01316770|147427844|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
73976725|NCT00683800|147499463|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.87|||<|0.001|TWO_SIDED|95.0|-2.57|-1.18|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.18|-2.57|<0.001
73947705|NCT00069784|147427877|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.022||||0.6273|TWO_SIDED|95.0|0.937|1.114||For the analysis of the two coprimary efficacy outcomes, the overall Type 1 error was partitioned. The first coprimary outcome was tested at 4.4%, whereas the second coprimary outcome was tested at 1% (weighted Hochberg procedure).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|The total required number of first coprimary outcomes (2200) assumed that a hazard reduction of 14-16% was clinically significant and controlled the overall experiment-wise Type 1 error at 5% with a power of 80% for each outcome. The total number of participants needed to achieve this number of events within the planned enrollment and treatment periods was ultimately estimated to be 12 500 based on the CURE and HOPE study databases.||1.114|0.937|0.6273
73947706|NCT00069784|147427878|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.038||||0.2692|TWO_SIDED|95.0|0.972|1.109||The second coprimary outcome was tested at 1% (see above additional information for the first coprimary outcome).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|See above additional details provided for the analysis of the first coprimary outcome.||1.109|0.972|0.2692
73947707|NCT00069784|147427879|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.983|||||TWO_SIDED|95.0|0.899|1.076|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.|||1.076|0.899|
73947708|NCT00069784|147427880|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97|||||TWO_SIDED|95.0|0.9|1.047|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.|||1.047|0.900|
73947709|NCT00069784|147427881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.58|0.91|||||Odds ratio estimated using Cochran-Mantel-Haenszel (CMH) test method stratified by double-blind treatment (omega-3 PUFA or placebo) and previous cardiovascular event (yes or no).|||0.91|0.58|
73947710|NCT01672853|147427903|SUPERIORITY||Difference in LS Mean|-0.4|||||TWO_SIDED|95.0|-2.3|1.6||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||1.6|-2.3|
73947711|NCT01672853|147427903|SUPERIORITY||Difference in LS Mean|1.0|||||TWO_SIDED|95.0|-1.0|3.0||||||A MMRM with an unstructured variancecovariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||3.0|-1.0|
73947712|NCT01265030|147427907|SUPERIORITY||Mean Difference (Net)|0.75||||0.63|TWO_SIDED|95.0|-2.54|4.04|||t-test, 2 sided|||||4.04|-2.54|0.63
73947713|NCT01265030|147427907|SUPERIORITY||Mean Difference (Net)|-1.95||||0.31|TWO_SIDED|95.0|-6.08|2.19|||t-test, 2 sided|||||2.19|-6.08|0.31
73947714|NCT01265030|147427908|SUPERIORITY||Mean Difference (Net)|0.063||||0.68|TWO_SIDED|95.0|-0.286|0.411|||t-test, 2 sided|||The mean difference in pain score at week 1 and before surgery||0.411|-.286|0.68
73870375|NCT03139344|147284557|SUPERIORITY|||||||0.069|||||||ANOVA|||||||0.069
73870376|NCT03139344|147284557|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
73947715|NCT01590771|147427920|SUPERIORITY_OR_OTHER||Robust regression|-0.61|||<|0.001|TWO_SIDED|95.0|-0.77|-0.44||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline A1C value.|ANCOVA||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline A1C value.|||-0.44|-0.77|<0.001
73947716|NCT01590771|147427921|SUPERIORITY_OR_OTHER||Difference in least squares mean|-32.9|||<|0.001|TWO_SIDED|95.0|-45.4|-20.4||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline 2-hr PMG value.|ANCOVA|||||-20.4|-45.4|<0.001
73947717|NCT01590771|147427922|SUPERIORITY_OR_OTHER||Estimate difference|-16.8|||<|0.001|TWO_SIDED|95.0|-23.3|-10.2||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline FPG value.|Robust regression|||||-10.2|-23.3|<0.001
73947718|NCT01590771|147427923|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.41|||<|0.001|TWO_SIDED|95.0|-0.63|-0.2||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA|||||-0.20|-0.63|<0.001
73947719|NCT01590771|147427924|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.8|||<|0.001|TWO_SIDED|95.0|-1.07|-0.53||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA|||||-0.53|-1.07|<0.001
73947720|NCT01590771|147427925|SUPERIORITY_OR_OTHER||Estimate difference|-27.2|||<|0.001|TWO_SIDED|95.0|-41.2|-13.2||Based on robust regression using M-estimation with terms for treatment and baseline 2-hr PMG value.|Robust regression|||||-13.2|-41.2|<0.001
73947721|NCT01590771|147427926|SUPERIORITY_OR_OTHER||Difference in least squares mean|-37.7|||<|0.001|TWO_SIDED|95.0|-56.9|-18.4||The ANCOVA model controlled for treatment and baseline 2-hr PMG value.|ANCOVA|||||-18.4|-56.9|<0.001
73947722|NCT01590771|147427927|SUPERIORITY_OR_OTHER||Estimate Difference|-16.5|||<|0.001|TWO_SIDED|95.0|-25.3|-7.8||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression|||||-7.8|-25.3|<0.001
73947723|NCT01590771|147427928|SUPERIORITY_OR_OTHER||Estimate Difference|-17.0|||<|0.001|TWO_SIDED|95.0|-26.9|-7.1||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression|||||-7.1|-26.9|<0.001
73947724|NCT02019563|147427935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34||||0.15|TWO_SIDED|95.0|0.08|1.49|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.||1.49|.08|.15
73870377|NCT03139344|147284558|SUPERIORITY|||||||0.118|||||||ANOVA|||||||0.118
73870378|NCT03139344|147284558|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.010
73870379|NCT03139344|147284559|SUPERIORITY|||||||0.059|||||||ANOVA|||||||0.059
73870380|NCT03139344|147284559|SUPERIORITY|||||||0.015|||||||ANOVA|||||||0.015
73947725|NCT02019563|147427936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.38|TWO_SIDED|95.0|0.19|1.89|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.||1.89|.19|.38
73976726|NCT00683800|147499463|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.9|-0.41|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.41|-0.90|<0.001
73976727|NCT00683800|147499463|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.58|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.37|-0.80|<0.001
73947726|NCT02019563|147427937|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.||||.51
73947727|NCT02019563|147427938|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.||||.64
73947728|NCT02019563|147427939|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||The p-value represents the survival rate from the Kaplan-Meier survival analysis from 6 to 36 months.|Log Rank|||||||.11
73870381|NCT03139344|147284560|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.010
73870382|NCT03139344|147284560|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
73870383|NCT03139344|147284561|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
73870384|NCT03139344|147284562|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||||||0.345
73870385|NCT03139344|147284563|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|||||||0.264
73870386|NCT03139344|147284564|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
73870387|NCT03139344|147284565|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
73870388|NCT03139344|147284566|SUPERIORITY|||||||0.109|||||||t-test, 2 sided|||||||0.109
73870389|NCT03139344|147284567|SUPERIORITY|||||||0.895|||||||t-test, 2 sided|||||||0.895
73870390|NCT03139344|147284568|SUPERIORITY|||||||0.573|||||||t-test, 2 sided|paired t-test||||||0.573
73870391|NCT03139344|147284569|SUPERIORITY|||||||0.858|||||||t-test, 2 sided|paired t-test||||||0.858
73870392|NCT03052049|147284572|OTHER|t-test|p value|0.05||||0.05|TWO_SIDED|0.0||||P value was calculated with threshold of significance \<0.05.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.05
73870393|NCT03052049|147284573|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
73870394|NCT03052049|147284574|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
73870395|NCT03052049|147284575|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
73870396|NCT03052049|147284576|SUPERIORITY|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
73870397|NCT00122369|147284578|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant|t-test, 2 sided|||The impact of knowing or not knowing the diagnosis became so overwhelming and group composition with regard of whether and which result had been communicated changed daily in the post-biopsy follow-up, so that the originally planned analysis of the impact of Self-Hynotic Relaxation or Empathic Attention on cortisol measures became underpowered. Therefore we focused on the analysis of the impact of diagnosis.||||0.014
73870398|NCT00122369|147284578|SUPERIORITY_OR_OTHER|||||||0.421||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant.|t-test, 2 sided|||||||0.421
73870399|NCT00122369|147284578|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant.|t-test, 2 sided|||||||0.138
73870400|NCT00122369|147284579|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||The null-hypothesis was that there would be no difference among groups.||||0.56
73870401|NCT00122369|147284591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
73870402|NCT00122369|147284591|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Ordinal regression|||||||0.45
73870403|NCT00122369|147284591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
73870404|NCT00122369|147284591|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Proportional odds model|||||||<0.01
73870405|NCT00122369|147284591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Proportional odds model|||||||<0.001
73947729|NCT00856934|147427958|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
73947730|NCT00856934|147427959|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
73947731|NCT01015807|147427991|OTHER|||||||0.48|||||||ANOVA|||We estimated that 25 subjects per group would allow us to detect a reduction of this area from 7.5 cm2 in our placebo group to 3.5 cm2 in the CloTAP group, with SD = 5 cm2 in both groups, owing to improved overall analgesia and reduced pain sensitization in women allocated to receive a TAP block with clonidine (2-tailed \[alpha\] = 0.05, 80% power). To allow for failed TAP blocks and/or exclusions of cases, we included 30 patients per group (n = 90)||||0.48
73947732|NCT01077362|147428035|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73947733|NCT01077362|147428035|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73947734|NCT01077362|147428035|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73947735|NCT01077362|147428036|SUPERIORITY_OR_OTHER|||||||0.002|||||||re-randomization test|||||||0.002
73947736|NCT01077362|147428036|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73947737|NCT01077362|147428036|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73947738|NCT01077362|147428037|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73976728|NCT00683800|147499463|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04||||0.282|TWO_SIDED|95.0|-0.13|0.04|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.04|-0.13|0.282
73976729|NCT00683800|147499463|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.24|||<|0.001|TWO_SIDED|95.0|-1.66|-0.82|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.82|-1.66|<0.001
73976730|NCT00683800|147499463|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17||||0.14|TWO_SIDED|95.0|-0.41|0.06|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.06|-0.41|0.140
73976731|NCT00683800|147499463|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.56|-0.26|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.26|-0.56|<0.001
73976732|NCT00683800|147499464|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.71|||<|0.001|TWO_SIDED|95.0|-2.42|-1.0|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.00|-2.42|<0.001
73976733|NCT00683800|147499464|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.81|-0.3|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.30|-0.81|<0.001
73947739|NCT01077362|147428037|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73947740|NCT01077362|147428037|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73947741|NCT01077362|147428038|SUPERIORITY_OR_OTHER|||||||0.018|||||||re-randomization test|||||||0.018
73947742|NCT01077362|147428038|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73947743|NCT01077362|147428038|SUPERIORITY_OR_OTHER|||||||0.002|||||||re-randomization test|||||||0.002
73947744|NCT01077362|147428039|SUPERIORITY_OR_OTHER|||||||0.017|||||||re-randomization test|||||||0.017
73947745|NCT01077362|147428039|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73947746|NCT01077362|147428039|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
73947747|NCT01077362|147428040|SUPERIORITY_OR_OTHER|||||||0.171|||||||re-randomization|||||||0.171
73947748|NCT01077362|147428040|SUPERIORITY_OR_OTHER|||||||0.06|||||||re-randomization test|||||||0.060
73947749|NCT01077362|147428040|SUPERIORITY_OR_OTHER|||||||0.094|||||||re-randomization|||||||0.094
73947750|NCT02247804|147428053|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.39||0.295|TWO_SIDED|95.0|-1.17|0.36|||MMRM|||Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.36|-1.17|0.2950
73947751|NCT02247804|147428053|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.39||0.3904|TWO_SIDED|95.0|-1.09|0.43|||MMRM|||Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.43|-1.09|0.3904
73947752|NCT02247804|147428053|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0464|TWO_SIDED|95.0|-1.4|-0.01|||MMRM|||Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||-0.01|-1.40|0.0464
73947753|NCT02247804|147428053|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.5383|TWO_SIDED|95.0|-0.9|0.47|||MMRM|||Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.47|-0.90|0.5383
73947754|NCT02247804|147428054|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.34||0.0033|TWO_SIDED|95.0|-1.68|-0.34|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.68|0.0033
73947755|NCT02247804|147428054|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0187|TWO_SIDED|95.0|-1.47|-0.13|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.13|-1.47|0.0187
73947756|NCT02247804|147428055|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.31||0.0057||95.0|-1.45|-0.25|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.25|-1.45|0.0057
73947757|NCT02247804|147428055|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.0031||95.0|-1.5|-0.31|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.31|-1.50|0.0031
73947758|NCT02247804|147428056|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.32||0.0547||95.0|-1.26|0.01|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.01|-1.26|0.0547
73947759|NCT02247804|147428056|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0107||95.0|-1.46|-0.19|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.19|-1.46|0.0107
73947760|NCT02247804|147428057|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.32||0.086||95.0|-1.16|0.08|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.08|-1.16|0.0860
73947761|NCT02247804|147428057|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.27|0.0362
73947762|NCT02247804|147428058|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.39||0.295||95.0|-1.17|0.36|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.36|-1.17|0.2950
74032099|NCT02749721|147617308|OTHER||F statistic|0.214||||0.645|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.645
74032100|NCT02749721|147617309|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
73870406|NCT00122369|147284591|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Proportional odds model|||||||<0.01
73870407|NCT00122369|147284604|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
73870408|NCT00122369|147284604|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
73947763|NCT02247804|147428058|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.39||0.3904|TWO_SIDED|95.0|-1.09|0.43|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.43|-1.09|0.3904
73947764|NCT02247804|147428059|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0464||95.0|-1.4|-0.01|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.01|-1.40|0.0464
73947765|NCT02247804|147428059|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.5383||95.0|-0.9|0.47|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.47|-0.90|0.5383
73976734|NCT00683800|147499464|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.62|||<|0.001|TWO_SIDED|95.0|-0.83|-0.4|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.40|-0.83|<0.001
73976735|NCT00683800|147499464|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08||||0.082|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.01|-0.17|0.082
73976736|NCT00683800|147499464|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.61|-0.75|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.75|-1.61|<0.001
73870409|NCT00122369|147284604|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
73870410|NCT00122369|147284604|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Proportional odds model|||||||0.024
73870411|NCT00122369|147284604|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Proportional odds model|||||||0.018
73870412|NCT00122369|147284604|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Proportional odds model|||||||0.73
73870413|NCT00999518|147284605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.4|0.35||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% confidence interval (CI).||0.35|-0.40|
73870414|NCT00999518|147284605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.8|0.68||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.68|-0.80|
73870415|NCT00999518|147284605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-1.15|0.83||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.83|-1.15|
73870416|NCT00999518|147284605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.93|0.47||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.47|-0.93|
73870417|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.66|||||TWO_SIDED|95.0|0.259|1.683||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.683|0.259|
73870418|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.975|||||TWO_SIDED|95.0|0.387|2.457||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.457|0.387|
73870419|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.969|||||TWO_SIDED|95.0|0.392|2.398||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.398|0.392|
73870420|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.969|||||TWO_SIDED|95.0|0.392|2.398||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.398|0.392|
73947766|NCT02247804|147428060|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.34||0.0033|TWO_SIDED|95.0|-1.68|-0.34|||MMRM|||Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.68|0.0033
73947767|NCT02247804|147428060|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0187|TWO_SIDED|95.0|-1.47|-0.13|||MMRM|||Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.13|-1.47|0.0187
73947768|NCT02247804|147428060|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.31||0.0057|TWO_SIDED|95.0|-1.45|-0.25|||MMRM|||Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.25|-1.45|0.0057
73947769|NCT02247804|147428060|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.0031|TWO_SIDED|95.0|-1.5|-0.31|||MMRM|||Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.31|-1.50|0.0031
73947770|NCT02247804|147428060|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.32||0.0547|TWO_SIDED|95.0|-1.26|0.01|||MMRM|||Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.01|-1.26|0.0547
73976737|NCT00683800|147499464|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02||||0.865|TWO_SIDED|95.0|-0.25|0.21|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.21|-0.25|0.865
74032101|NCT02749721|147617310|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
74032102|NCT02749721|147617311|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
74032103|NCT02749721|147617312|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
73976738|NCT00683800|147499464|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.61|-0.29|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.29|-0.61|<0.001
73976739|NCT00683800|147499465|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976740|NCT00683800|147499466|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976741|NCT00683800|147499467|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976742|NCT00683800|147499468|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976743|NCT00683800|147499469|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976744|NCT00683800|147499470|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976745|NCT00683800|147499471|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976746|NCT00683800|147499472|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976747|NCT00683800|147499473|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976748|NCT00683800|147499474|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976749|NCT00683800|147499475|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976750|NCT00683800|147499476|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
73976751|NCT00683800|147499477|SUPERIORITY_OR_OTHER||Wald Formula|1.11|||||TWO_SIDED|90.0|-0.68|2.9|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||2.9|-0.68|
73870421|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.629|||||TWO_SIDED|95.0|0.202|1.96||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.960|0.202|
73947771|NCT02247804|147428060|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0107|TWO_SIDED|95.0|-1.46|-0.19|||MMRM|||Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.19|-1.46|0.0107
73976752|NCT00683800|147499479|SUPERIORITY_OR_OTHER||Wald Formula|2.31|||||TWO_SIDED|90.0|-2.08|6.71|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||6.71|-2.08|
73947772|NCT02247804|147428060|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.32||0.086|TWO_SIDED|95.0|-1.16|0.08|||MMRM|||Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.08|-1.16|0.0860
73947773|NCT02247804|147428060|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.27|0.0362
73947774|NCT02917265|147428061|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
73947775|NCT00692406|147428082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0023|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
73947776|NCT00692406|147428083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1167|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
73947777|NCT00692406|147428084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0253|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
73870422|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.179|||||TWO_SIDED|95.0|0.411|3.376||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.376|0.411|
73870423|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.222|||||TWO_SIDED|95.0|0.438|3.414||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.414|0.438|
73870424|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.778|||||TWO_SIDED|95.0|0.259|2.335||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.335|0.259|
73947778|NCT00692406|147428085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1432|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
73947779|NCT00692406|147428086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0489|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
73947780|NCT00692406|147428087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0096|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
73947781|NCT00692406|147428088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0372|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
73947782|NCT00692406|147428089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
73947783|NCT01097915|147428094|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
73947784|NCT01097915|147428095|SUPERIORITY_OR_OTHER||||||<|0.004|||||||ANOVA|||||||<0.004
73947785|NCT01097915|147428096|SUPERIORITY_OR_OTHER||||||<|0.048|||||||ANCOVA|the three factors of the Stunkard and Messick Questionnaire were considered as covariates.||||||<0.048
73947786|NCT01097915|147428097|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||ANOVA|||||||< 0.00001
73947787|NCT01097915|147428098|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||ANOVA|||||||< 0.00001
73947788|NCT01097915|147428099|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Chi-squared|||||||< 0.00001
73947789|NCT05652036|147428110|OTHER|||||||0.21||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NPS score pre- and post-procedure||||0.21
73947790|NCT05652036|147428111|OTHER|||||||0.07||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in overactive bladder symptom bother before and after treatment||||.07
73947791|NCT05652036|147428111|OTHER|||||||0.16||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in overactive bladder HRQL mean before and after treatment||||0.16
73947792|NCT05652036|147428112|OTHER|||||||0.21|||||||Chi-squared|||Participant rated procedural satisfaction assessed 30-days post-procedure.||||0.21
73947793|NCT05652036|147428113|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as very much improved after treatment||||||0.79|||||||Chi-squared|||||||0.79
73947794|NCT05652036|147428113|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as much improved after treatment||||||0.27|||||||Chi-squared|||||||0.27
73947795|NCT05652036|147428113|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as minimally improved after treatment||||||0.14|||||||Chi-squared|||||||0.14
73947796|NCT05652036|147428113|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as no difference after treatment||||||1|||||||Chi-squared|||||||1.0
73947797|NCT05652036|147428114|OTHER|Rates of urinary retention observed in participants after BTX-A treatment.||||||0.5|||||||Chi-squared|||||||0.5
73947798|NCT05652036|147428114|OTHER|Rates of urinary tract infection observed in participants after BTX-A treatment.||||||0.24|||||||Chi-squared|||||||0.24
73947799|NCT05652036|147428114|OTHER|Rates of bleeding requiring evaluation observed in participants after BTX-A treatment.||||||1|||||||Chi-squared|||||||1.0
73947800|NCT05652036|147428114|OTHER|Rates of hematuria observed in participants after BTX-A treatment.||||||0.46|||||||Chi-squared|||||||0.46
73947801|NCT05652036|147428114|OTHER|Rates of bladder pain observed in participants after BTX-A treatment.||||||1|||||||Chi-squared|||||||1.0
73947802|NCT05652036|147428114|OTHER|Rates of ER department evaluations observed in participants after BTX-A treatment.||||||0.5|||||||Chi-squared|||||||0.5
73947803|NCT05408468|147428167|SUPERIORITY||Mean Difference (Net)|-5.595|STANDARD_ERROR_OF_MEAN|1.731||0.387|TWO_SIDED||||||Mixed Models Analysis||Baseline 1.731 One week 1.894|||||0.387
73947804|NCT05408468|147428167|SUPERIORITY||Mean Difference (Net)|-3.782|STANDARD_ERROR_OF_MEAN|2.048||0.387|TWO_SIDED||||||Mixed Models Analysis||Baseline 2.048 One week 2.122|||||0.387
73947805|NCT05408468|147428168|SUPERIORITY||Mean Difference (Net)|-4.5|STANDARD_ERROR_OF_MEAN|1.693||0.062|TWO_SIDED||||||Mixed Models Analysis||Baseline 1.693 One week 1.840|||||0.062
73947806|NCT05408468|147428168|SUPERIORITY||Mean Difference (Net)|-0.764|STANDARD_ERROR_OF_MEAN|2.003||0.062|TWO_SIDED||||||Mixed Models Analysis||Baseline 2.003 One week 2.069|||||0.062
73947807|NCT05408468|147428170|SUPERIORITY||Median Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|2.84||0.369|TWO_SIDED||||||t-test, 2 sided|||||||0.369
73947808|NCT05408468|147428171|SUPERIORITY||Median Difference (Final Values)|2.59|STANDARD_ERROR_OF_MEAN|3.79||0.498|TWO_SIDED||||||t-test, 2 sided|||||||0.498
73947809|NCT00930943|147428181|SUPERIORITY||||||<|0.001||||||repeated-measure ANOVA tested time-post-dose effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA|||The a priori sample-size estimation for a power of 80% with alpha = 0.05 was based on the primary-outcome measure, the rapid visual information processing (RVP) sensitivity (A') score. Using a repeated-measure ANOVA for the food effect (fed versus fasting) and assuming an effect size of f =0.26 generated a required sample size of 32 participants. However, only 30 subjects completed both testing visits, generating a power of 78.2%.|(F\[1,28\] = 22.71; η2 = 0.45)|||<0.001
73947810|NCT00930943|147428181|SUPERIORITY|||||||0.01||||||repeated-measure ANOVA tested food x time-post-dose effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA||||F\[1,28\]=6.88; η2=0.20|||0.01
73947811|NCT00930943|147428181|SUPERIORITY||||||>|0.05||||||repeated-measure ANOVA testing food effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA|||||||>0.05
73947812|NCT00930943|147428182|SUPERIORITY||||||<|0.001||||||Repeated-measure ANOVA testing time-post-dose effect for Rapid Visual Information Processing (RVP): response latency|ANOVA||||(F\[1,28\] = 14.05; η2 = 0.33)|||<0.001
73947813|NCT00930943|147428182|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food and food x time post dose effect for Rapid Visual Information Processing (RVP): response latency"|ANOVA|||||||>0.05
73947814|NCT00930943|147428183|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SRM percentage of correct hits"|ANOVA|||||||>0.05
73947815|NCT00930943|147428184|SUPERIORITY||||||<|0.001||||||Repeated-measure ANOVA testing time-post-dose effect for Spatial Recognition Memory (SRM) response latency|ANOVA||||(F\[1,28\] = 31.26; η2 = 0.53)|||<0.001
73947816|NCT00930943|147428184|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food and food x time-post-dose effect for SRM response latency"|ANOVA|||||||>0.05
73947817|NCT00930943|147428185|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SWM total errors"|ANOVA|||||||>0.05
73947818|NCT00930943|147428186|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SWM strategy score"|ANOVA|||||||>0.05
73947819|NCT00405639|147428189|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73947820|NCT00405639|147428190|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73947821|NCT00405639|147428191|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
73947822|NCT00405639|147428192|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73947823|NCT00612534|147428193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.26|STANDARD_ERROR_OF_MEAN|7.83||0.194||95.0|-5.32|25.83|||ANCOVA|||||25.83|-5.32|0.194
73947824|NCT00612534|147428193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.67|STANDARD_ERROR_OF_MEAN|7.77||0.268|TWO_SIDED|95.0|-6.78|24.11|||ANCOVA|||||24.11|-6.78|0.268
73947825|NCT00612534|147428193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.05|STANDARD_ERROR_OF_MEAN|8.3||0.018|TWO_SIDED|95.0|3.54|36.56|||ANCOVA|||||36.56|3.54|0.018
73947826|NCT04466215|147428240|SUPERIORITY||Slope|-0.063|STANDARD_ERROR_OF_MEAN|0.04||0.065|TWO_SIDED|||||One-tail test of directional hypothesis.|Mixed Models Analysis|||Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictor was drug plasma concentration. Arms were combined for this analysis.||||.065
73947827|NCT00926003|147428244|SUPERIORITY|||||||0.02|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ART at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline||||0.02
73947828|NCT00926003|147428245|SUPERIORITY|||||||0.18|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ARV at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline||||0.18
73976753|NCT00683800|147499480|SUPERIORITY_OR_OTHER||Wald Formula|0.08|||||TWO_SIDED|90.0|-3.51|3.67|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||3.67|-3.51|
73976754|NCT01953692|147499491|SUPERIORITY||||||>|0.9999||||||one-sided p value|exact binomial distribution|||Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10||||>0.9999
73976755|NCT01953692|147499492|SUPERIORITY||||||>|0.9999||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25||||>0.9999
73976756|NCT01953692|147499493|SUPERIORITY|||||||0.0306||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10||||0.0306
73976757|NCT01953692|147499494|SUPERIORITY|||||||0.7696||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25||||0.7696
73976758|NCT00176202|147499540|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
73976759|NCT00176202|147499540|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
73976760|NCT00176202|147499541|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<.01
73976761|NCT00176202|147499541|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||||||0.01
73976762|NCT00176202|147499542|SUPERIORITY_OR_OTHER||effect size|-1.59|||<|0.01|TWO_SIDED|||||In case of both risperidone and divalproex sodium.|Chi-squared|||||||<0.01
73976763|NCT00176202|147499542|SUPERIORITY_OR_OTHER||Effect size|-1.33|||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
73976764|NCT00176202|147499543|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||baseline is compared to LOCF to determine the p value.||||<0.01
73976765|NCT00176202|147499543|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
73976766|NCT01886872|147499554|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.26|0.58||(1-sided)|Log Rank|||Arm B (Ibrutinib) versus Arm A (Rituximab, Bendamustine Hydrochloride)||0.58|0.26|<0.001
73976767|NCT01886872|147499554|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.001|TWO_SIDED|95.0|0.25|0.59||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm A (Rituximab, Bendamustine Hydrochloride)||0.59|0.25|<0.001
73976768|NCT01886872|147499554|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.49|TWO_SIDED|95.0|0.62|1.62||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm B (Ibrutinib)||1.62|0.62|0.49
73976769|NCT04941482|147499564|SUPERIORITY||Median Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|1.3|<|0.05|TWO_SIDED|95.0|-1.9|3.2||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Patient Health Questionnaire-9 score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|3.2|-1.9|<0.05
73976770|NCT04941482|147499565|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.05|TWO_SIDED|95.0|-7.6|2.5||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Fatigue Severity Scale score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|2.5|-7.6|<0.05
73976771|NCT04941482|147499566|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|95.0|-5.4|1.3||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Mini-Mental State Examinationscore before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|1.3|-5.4|<0.05
73976772|NCT04941482|147499567|SUPERIORITY|Over 6 months, the number of patients who losted to follow-up of intervention and control group were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months).|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|7.4|<|0.05|TWO_SIDED|95.0|-14.5|14.7|||t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Barthel Index score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|14.7|-14.5|<0.05
73947829|NCT02294474|147428252|NON_INFERIORITY|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 \& Humalog was \<0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure: if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested and demonstrated if lower bound of 2-sided 95% CI of difference between SAR342434 \& Humalog\>-0.3%.|Least Square (LS) Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.215|0.067|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit (Week 12, Week 26) and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.||0.067|-0.215|
73976773|NCT04941482|147499568|SUPERIORITY||Mean Difference (Net)|-7.6|STANDARD_ERROR_OF_MEAN|5.6|<|0.05|TWO_SIDED|95.0|-18.8|3.7||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Physical domain score of Stroke Impact Scale before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|3.7|-18.8|<0.05
73976774|NCT04941482|147499569|SUPERIORITY||Mean Difference (Net)|-7.8|STANDARD_ERROR_OF_MEAN|-3.7|<|0.05|TWO_SIDED|95.0|-15.2|-0.3||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Stroke Impact Scale score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|-0.3|-15.2|<0.05
73976775|NCT05966155|147499570|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.677|TWO_SIDED|95.0|-1.54|1.0|||t-test, 2 sided|||||1.00|-1.54|0.677
73976776|NCT05966155|147499571|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.1264|TWO_SIDED|95.0|-1.4|0.2|||t-test, 2 sided|||||0.2|-1.4|0.1264
73976777|NCT05966155|147499572|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.3692|TWO_SIDED|95.0|-0.4|1.1|||t-test, 2 sided||The by-group means and the estimated mean difference are independently rounded to the nearest tenth. As a result, the mean difference it not exactly equivalent to the difference in the two reported means.|||1.1|-0.4|0.3692
73976778|NCT05966155|147499573|SUPERIORITY|||||||0.8492|||||||Chi-squared|||||||0.8492
73976779|NCT05966155|147499574|SUPERIORITY|||||||0.0246|||||||Chi-squared|||||||0.0246
73976780|NCT05966155|147499575|SUPERIORITY|||||||0.0111|||||||Chi-squared|||||||0.0111
73976781|NCT05966155|147499576|SUPERIORITY|||||||0.0776|||||||Chi-squared|||||||0.0776
73976782|NCT05966155|147499577|SUPERIORITY|||||||0.0014|||||||Chi-squared|||||||0.0014
73976783|NCT06193590|147499581|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
73976784|NCT06193590|147499582|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.1
73976785|NCT06193590|147499584|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
73976786|NCT01706159|147499604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.16||||0.3056||90.0|0.01|3.05||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||A sample size of 90 subjects, with a 2:1 (active:placebo) randomization ratio, would ensure 80% power to detect a difference between active treatment and placebo at Week 8 with a 2-sided significance level of 10% based on a Fisher's exact test.||3.05|0.01|0.3056
73976787|NCT03775486|147499626|OTHER||Hazard Ratio (HR)|0.76||||0.074|TWO_SIDED|95.0|0.57|1.02|||Log Rank|||||1.02|0.57|0.074
73976788|NCT03775486|147499626|OTHER||Median|7.2|||||TWO_SIDED|95.0|5.3|7.9||||||Median progression-free survival (months)||7.9|5.3|
73976789|NCT03775486|147499626|OTHER||Median|5.3|||||TWO_SIDED|95.0|3.7|5.8||||||Median progression-free survival (months)||5.8|3.7|
73976790|NCT03775486|147499627|OTHER||Hazard Ratio (HR)|0.9||||0.604|TWO_SIDED|95.0|0.59|1.36|||Log Rank|||||1.36|0.59|0.604
73976791|NCT03775486|147499627|OTHER||Median|17.4|||||TWO_SIDED|95.0|14.1||NA = insufficient number of participants with events|||||Median overall survival (months)|||14.1|
73976792|NCT03775486|147499627|OTHER||Median overall survival (months)|11.8|||||TWO_SIDED|95.0|11.8||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value|Median overall survival (months)|||11.8|
73976793|NCT03775486|147499629|OTHER|Median duration of response (months)|Median duration of response|6.5|||||TWO_SIDED|95.0|6.5||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value||||6.5|
73976794|NCT03775486|147499629|OTHER|Median duration of response (months)|Median duration of response|3.8|||||TWO_SIDED|95.0|3.8||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value||||3.8|
73870425|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.929|||||TWO_SIDED|95.0|0.37|2.327||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.327|0.370|
73870426|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.083|||||TWO_SIDED|95.0|0.427|2.749||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.749|0.427|
73870427|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.759|||||TWO_SIDED|95.0|0.295|1.952||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.952|0.295|
73870428|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.759|||||TWO_SIDED|95.0|0.295|1.952||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.952|0.295|
73870429|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.875|||||TWO_SIDED|95.0|0.285|2.682||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.682|0.285|
73947830|NCT05200936|147428263|SUPERIORITY|||||||0.7145||||||p-value is 1-sided|Mixed Models Analysis|||||||0.7145
73947831|NCT05200936|147428264|SUPERIORITY|||||||0.9613|||||||ANCOVA|||||||0.9613
73947832|NCT05473000|147428299|SUPERIORITY|||||||0.092|||||||t-test, 2 sided|||||||0.092
73976795|NCT03775486|147499630|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.07|2.0||||||||2.00|0.07|
73870430|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.366|||||TWO_SIDED|95.0|0.466|4.006||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||4.006|0.466|
73870431|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.235|2.394||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.394|0.235|
73870432|NCT00999518|147284607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.063|||||TWO_SIDED|95.0|0.356|3.168||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.168|0.356|
73870433|NCT00999518|147284610|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.263||||0.5731|TWO_SIDED|95.0|0.56|2.848|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.848|0.560|0.5731
73870434|NCT00999518|147284610|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.656||||0.2592|TWO_SIDED|95.0|0.689|3.98|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||3.980|0.689|0.2592
73870435|NCT00999518|147284610|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9181||||1.045|TWO_SIDED|95.0|0.452|2.417|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.417|0.452|1.045
73870436|NCT00999518|147284610|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.306||||0.5289|TWO_SIDED|95.0|0.569|2.997|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.997|0.569|0.5289
73870437|NCT00999518|147284610|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.893||||0.793|TWO_SIDED|95.0|0.385|2.074|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.074|0.385|0.7930
73870438|NCT00999518|147284610|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.167||||0.7386|TWO_SIDED|95.0|0.471|2.892|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.892|0.471|0.7386
73870439|NCT00999518|147284610|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.036||||0.9354|TWO_SIDED|95.0|0.437|2.46|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.460|0.437|0.9354
73947833|NCT05879198|147428301|SUPERIORITY|||||||0.473|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.473
73947834|NCT05879198|147428302|SUPERIORITY|||||||0.469|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.469
73947835|NCT05879198|147428303|SUPERIORITY|||||||0.155|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.155
73947836|NCT05879198|147428304|SUPERIORITY|||||||0.346|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.346
73947837|NCT05879198|147428306|SUPERIORITY|||||||0.075|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in AEQ-positive scale scores.||||.075
73947838|NCT05879198|147428306|SUPERIORITY|||||||0.32|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in AEQ-negative scale scores.||||.320
73947839|NCT05879198|147428306|SUPERIORITY|||||||0.049|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in MEEQ-positive scale scores.||||.049
73947840|NCT05879198|147428306|SUPERIORITY|||||||0.089|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in MEEQ-negative scale scores.||||.089
73947841|NCT00552786|147428398|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two-sided|ANOVA|Assessing the bioequivalence on temporary threshold shift at3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.||||||<0.05
73947842|NCT00552786|147428399|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|Assessing the bioequivalence on temporary threshold shift at 3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.||||||<0.05
73976796|NCT03775486|147499630|OTHER||Median (months)|3.7|||||TWO_SIDED|95.0|1.7||NA = insufficient number of participants with events|||||Median progression-free survival (months)|||1.7|
73947843|NCT03549234|147428401|NON_INFERIORITY|"We tested the noninferiority of ESPB compared to PVB (paravertebral block) using the 95% confidence interval (CI) associated with the Wilcoxon-Mann-Whitney Exact test. If the lower limit of the 95% CI for median average recovery room pain scores was greater than -1.25 (based on PVB minus ESPB), we concluded noninferiority. The noninferiority of ESPBs with regard to opioid consumption was similarly tested with a predefined noninferiority margin of 2 mg intravenous morphine equivalents."||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||We hypothesized that 1) analgesia would be noninferior in the recovery room as measured on a Numeric Rating Scale with ESPB (erector spinae plane block), and 2) opioid consumption would be noninferior in the operating and recovery rooms with ESPB. We simulated pain scores from a discrete distribution with median (interquartile range) 2 (0-3). The sample size of 50 per group provided 81% power to detect noninferiority in pain.||||0.0011
73976797|NCT03775486|147499630|OTHER||Median (months)|3.7|||||TWO_SIDED|95.0|1.2|16.6||||||Median progression-free survival (months)||16.6|1.2|
73976798|NCT03775486|147499632|OTHER||Estimated difference in adjusted mean|-0.51|||||TWO_SIDED|95.0|-4.47|3.46||||||EORTC QLQ-LC13: Dyspnoea Estimated difference in adjusted mean change from baseline.||3.46|-4.47|
73976799|NCT03775486|147499632|OTHER||Estimated difference in adjusted mean|0.95|||||TWO_SIDED|95.0|-4.81|6.71||||||EORTC QLQ-LC13: Coughing Estimated difference in adjusted mean change from baseline.||6.71|-4.81|
73947844|NCT03549234|147428402|NON_INFERIORITY|"We tested the noninferiority of ESPB compared to PVB using the 95% confidence interval (CI) associated with the Wilcoxon-Mann-Whitney Exact test. If the lower limit of the 95% CI for median average recovery room pain scores was greater than -1.25 (based on PVB minus ESPB), we concluded noninferiority. The noninferiority of ESPBs with regard to opioid consumption was similarly tested with a predefined noninferiority margin of 2 mg intravenous morphine equivalents."||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||||||0.0043
73976800|NCT03775486|147499632|OTHER||Estimated difference in adjusted mean|-2.26|||||TWO_SIDED|95.0|-6.39|1.88||||||EORTC QLQ-LC13: Pain in chest Estimated difference in adjusted mean change from baseline.||1.88|-6.39|
73976801|NCT03775486|147499634|OTHER||Estimated difference in adjusted mean|1.64|||||TWO_SIDED|95.0|-2.2|5.47||||||EORTC QLQ-C30: Fatigue Estimated difference in adjusted mean change from baseline.||5.47|-2.20|
73976802|NCT03775486|147499634|OTHER||Estimated difference in adjusted mean|3.22|||||TWO_SIDED|95.0|-1.46|7.9||||||EORTC QLQ-C30: Appetite loss Estimated difference in adjusted mean change from baseline.||7.90|-1.46|
74032104|NCT02749721|147617313|OTHER||Pearson's R|-0.044||||0.859|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-28 baseline scores||||0.859
73976803|NCT04119063|147499638|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.204|||||||t-test, 2 sided|||||||0.204
73976804|NCT04119063|147499639|OTHER|Paired t-test||||||0.049|||||||t-test, 2 sided|||||||0.049
73976805|NCT04119063|147499640|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.039|||||||t-test, 2 sided|||||||0.039
73976806|NCT04119063|147499641|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.242|||||||t-test, 2 sided|||||||0.242
73976807|NCT04119063|147499642|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.014|||||||t-test, 2 sided|||||||.014
73976808|NCT03102034|147499669|OTHER||% vaccine recipients with solicited AEs|76.0|||||TWO_SIDED|90.0|56.0|90.0|||||Confidence intervals were Exact Clopper-Pearson.|||90|56|
73976809|NCT03102034|147499669|OTHER||% placebo recipients with solicited AEs|18.0|||||TWO_SIDED|90.0|3.0|47.0|||||Confidence intervals were Exact Clopper-Pearson.|||47|3|
73976810|NCT03102034|147499670|OTHER||% vaccinees with unsolicited AEs|24.0|||||TWO_SIDED|90.0|10.0|44.0|||||Confidence intervals were Exact Clopper-Pearson.|||44|10|
73976811|NCT03102034|147499670|OTHER||% placebo with unsolicited AEs|9.0|||||TWO_SIDED|90.0|0.0|36.0|||||Confidence intervals were Exact Clopper-Pearson.|||36|0|
73976812|NCT03102034|147499675|SUPERIORITY||||||<|0.001||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.001
73976813|NCT03102034|147499676|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank|||||||<0.001
73976814|NCT02962102|147499693|SUPERIORITY|||||||0.52|||||||Fisher Exact|||||||0.52
73976815|NCT02962102|147499693|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
73976816|NCT02962102|147499694|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
73976817|NCT02962102|147499694|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
73976818|NCT02962102|147499695|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
73976819|NCT02962102|147499695|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
73976820|NCT00310180|147499705|SUPERIORITY|Since the noninferiority comparison is formulated using a conventional superiority null hypothesis described as above, a type II error corresponds to concluding that Arm B is not inferior when in fact it is. The design therefore uses a one-sided type I error of 10% and is planned to have 95% power (5% type II error). If the null hypothesis is rejected (at the one-sided 10% level), then it will be concluded that endocrine therapy alone is inferior to chemoendocrine therapy.|Hazard Ratio (HR)|1.08||||0.13|TWO_SIDED|95.0|0.94|1.24||One-sided p value for stratified Cox proportional hazard analysis, stratified on recurrence score, tumor size and menopausal status.|Regression, Cox|||This study uses a noninferiority design, but the noninferiority question is formulated using the conventional superiority null hypothesis of equal DFS on the two arms (that is, the null hypothesis is that Arm B is not inferior to Arm C). The alternative hypothesis is that Arm B has substantially worse DFS than Arm C, specified by a hazard ratio for B vs. C of 1.322.||1.24|0.94|0.13
73976821|NCT00310180|147499709|OTHER|Treatment-by-Age and RS subset was performed via Cox proportional hazard analysis||||||0.004|||||||Regression, Cox|||Treatment interaction test was performed for the 9 age by RS subsets (3 groups for each, age groups \<=50 vs. 51-65 vs. 66-75; RS groups 0-10 vs. 11-25 vs. \>25) in patients randomized to arms B and C||||0.004
74032105|NCT02749721|147617313|OTHER||Pearson's R|-0.211||||0.451|TWO_SIDED||||||Pearson's correlation|||AOB P3a (amplitude)||||0.451
74032106|NCT02749721|147617313|OTHER||Pearson's R|0.015||||0.957|TWO_SIDED||||||Pearson's correlation|||AOB P3b (amplitude)||||0.957
73870440|NCT00999518|147284610|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.805||||0.6207|TWO_SIDED|95.0|0.341|1.899|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||1.899|0.341|0.6207
73870441|NCT04255862|147284661|EQUIVALENCE|Bioequivalence (BE) was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC.|Geometric Mean Ratio|103.4|||||TWO_SIDED|90.0|86.4|123.8||||||||123.8|86.4|
73947845|NCT04022889|147428407|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|7.7|||TWO_SIDED|95.0|-3.5|6.2|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||6.2|-3.5|
73947846|NCT04022889|147428407|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|8.9|||TWO_SIDED|95.0|-6.4|4.8|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||4.8|-6.4|
73870442|NCT04255862|147284661|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC.|Geometric Mean Ratio|115.0|||||TWO_SIDED|90.0|97.9|135.0||||||||135.0|97.9|
73947847|NCT04022889|147428407|OTHER|Variant 1-BEST = Test Variant 1 Endpoint - Test BEST Endpoint|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|10.2|||TWO_SIDED|95.0|-5.0|8.7|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||8.7|-5.0|
73947848|NCT04022889|147428407|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|-2.5|2.6|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||2.6|-2.5|
73947849|NCT04022889|147428408|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|28.9|STANDARD_DEVIATION|16.5|||TWO_SIDED|95.0|18.5|39.4|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||39.4|18.5|
73976822|NCT03147287|147499723|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.62|TWO_SIDED|90.0|0.79|1.55||We reported two-sided p-values corresponding to two-sided α level of 0.10. The test statistic and p-value were taken from the Cox proportional hazards model score test.|Log Rank|The SAP intended stratified tests and models, however one stratum was only 9 patients making implementation of stratification questionable.|We checked the proportional hazards assumption by visually assessing the plot of log( log(survival)) vs log of survival times according to treatment assignment for parallelism. This was done overall and according to stratum.|The primary objective was investigated by comparing the PFS distributions between two treatment arms using a logrank test with one-sided α level of 0.05 (H0: PFS1≤PFS2; HA: PFS1\>PFS2). Hazard ratios were estimated from a Cox PH model (F+P / F, so that HR\<1 indicates reduced hazard of PFS event with F+P), with two sided 90% CIs (Wald) to align with the design and testing.||1.55|0.79|0.62
73976823|NCT03147287|147499724|SUPERIORITY|||||||1||||||P-value is two sided, for hypothesis test with two-sided α=0.10|Fisher Exact|||The objective response was reported with two-sided 90% CI and compared between two treatment arms using a (unstratified) Fisher's exact test;||||1.000
73870443|NCT04255862|147284662|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC0-t.|Geometric Mean Ratio|102.8|||||TWO_SIDED|90.0|87.0|121.5||||||||121.5|87.0|
73870444|NCT04255862|147284662|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC0-t.|Geometric Mean Ratio|113.4|||||TWO_SIDED|90.0|97.4|131.9||||||||131.9|97.4|
73870445|NCT04255862|147284663|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for Cmax.|Geometric Mean Ratio|104.0|||||TWO_SIDED|90.0|90.3|119.7||||||||119.7|90.3|
73947850|NCT04022889|147428408|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|25.5|STANDARD_DEVIATION|25.3|||TWO_SIDED|95.0|9.5|41.6|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||41.6|9.5|
73947851|NCT04022889|147428408|EQUIVALENCE|Variant 1-BEST = Test Variant 1 Endpoint - Test BEST Endpoint|Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|21.3|||TWO_SIDED|95.0|-12.7|15.8|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||15.8|-12.7|
73947852|NCT04022889|147428408|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|29.8|STANDARD_DEVIATION|18.5|||TWO_SIDED|95.0|21.8|37.8|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||37.8|21.8|
73947853|NCT02254408|147428457|SUPERIORITY||Treatment Difference|-0.33||||0.04|TWO_SIDED|95.0|-0.64|-0.02|||ANCOVA|||||-0.02|-0.64|0.040
73947854|NCT02254408|147428458|SUPERIORITY||Odds Ratio (OR)|0.5||||0.11|TWO_SIDED|95.0|0.22|1.18|||Cochran-Mantel-Haenszel|||||1.18|0.22|0.11
73947855|NCT02254408|147428458|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
73947856|NCT02254408|147428459|SUPERIORITY||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.28|3.63|||Cochran-Mantel-Haenszel|||||3.63|0.28|0.98
73947857|NCT02254408|147428459|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73947858|NCT02674490|147428510|SUPERIORITY|||||||0.54||||||Threshold for significance is two-sided alpha of 0.05.|Regression, Linear|The primary analysis was adjusted for aphasia type (Anomia, Broca, or other type), baseline aphasia severity (AQ), and age.||Sample Size Determination If sample size in each group is 20, we will have 89% power to detect a difference in means of 23 (the difference between A-tDCS mean change in accuracy of 33 and a sham mean change in accuracy of 10) assuming that the SD of change for both groups is 22.2 using a two group t-test with a two-sided alpha of 0.05.||||0.54
73947859|NCT03810313|147428527|NON_INFERIORITY|Non-inferiority was considered to be established if the lower limit of the corresponding 95% CI for the estimated between group difference (brolucizumab vs. aflibercept) on change from baseline in BCVA at Week 24 is \> -4 letters.|Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.2||0.173|TWO_SIDED|95.0|-5.2|-0.5|||ANOVA|||||-0.5|-5.2|0.173
73947860|NCT03029780|147428545|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|0.0|||||TWO_SIDED|95.0|-12.3|12.3||||||||12.3|-12.3|
73976824|NCT00089609|147499782|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||.02
73976825|NCT03926026|147499800|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0471|TWO_SIDED|95.0|-1.5|0.0|||t-test, 2 sided|||||0|-1.5|0.0471
73976826|NCT02824198|147499808|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (\>) 1/2 for each serotype.|Geometric mean of titer ratio|1.34|||||TWO_SIDED|95.0|0.998|1.79||||||Dengue Virus Serotype 1||1.79|0.998|
73976827|NCT02824198|147499808|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|0.603|||||TWO_SIDED|95.0|0.439|0.829||||||Dengue Virus Serotype 2||0.829|0.439|
73976828|NCT02824198|147499808|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|0.979|||||TWO_SIDED|95.0|0.746|1.28||||||Dengue Virus Serotype 3||1.28|0.746|
73976829|NCT02824198|147499808|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|1.27|||||TWO_SIDED|95.0|0.918|1.75||||||Dengue Virus Serotype 4||1.75|0.918|
73976830|NCT00790699|147499833|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||RM-ANOVA|||The results were evaluated to determine if any statistically significant changes in any of these measures between the first and final visit occurred and if these changes were associated with membership in the treatment or control group.||||>.05
73976833|NCT02909959|147499906|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.96|STANDARD_ERROR_OF_MEAN|3.03||0.331|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.331
73976834|NCT02909959|147499907|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|2.99||0.98|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.98
73976835|NCT02909959|147499908|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|-0.774|STANDARD_ERROR_OF_MEAN|2.99||0.797|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.797
73976836|NCT02909959|147499909|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|3.01||0.442|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.442
74032107|NCT02749721|147617313|OTHER||Pearson's R|-0.322||||0.166|TWO_SIDED||||||Pearson's correlation|||VGNG P200 (amplitude)||||0.166
73947861|NCT03029780|147428545|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.30|
73947862|NCT03029780|147428546|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
73947863|NCT03029780|147428547|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|5.8|||||TWO_SIDED|95.0|-13.3|24.8||||||||24.8|-13.3|
73947864|NCT03029780|147428547|SUPERIORITY||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.58|2.78|||Cochran-Mantel-Haenszel|||||2.78|0.58|
73947865|NCT03029780|147428548|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|7.7|||||TWO_SIDED|95.0|-10.1|25.5||||||||25.5|-10.1|
73947866|NCT03029780|147428548|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.62|3.24|||Cochran-Mantel-Haenszel|||||3.24|0.62|
73947867|NCT01872910|147428589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.0|||||TWO_SIDED|95.0|-2.1|20.0|||||95% CrI is reported here, not the CI.|||20.0|-2.1|
73947868|NCT01872910|147428589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.6|||||TWO_SIDED|95.0|-45.7|-23.2|||||95% CrI is reported here, not the CI.|||-23.2|-45.7|
73947869|NCT01872910|147428589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.6|||||TWO_SIDED|95.0|32.7|54.9|||||95% CrI is reported here, not the CI.|||54.9|32.7|
73947870|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-2.9|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||0.2|-2.9|
73947871|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5|||||TWO_SIDED|95.0|2.9|6.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||6.0|2.9|
73947872|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-7.4|-4.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||-4.3|-7.4|
73947873|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-5.2|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||0.2|-5.2|
73947874|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|4.4|9.8|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||9.8|4.4|
73947875|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6|||||TWO_SIDED|95.0|-12.2|-6.9|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||-6.9|-12.2|
73947876|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-7.9|-0.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||-0.1|-7.9|
74009126|NCT03492554|147568949|OTHER||||||<|0.0001|||||||1 sided exact binomial test|||H0: Specificity = 92% H1: Specificity \> 92 Under the assumption that the true population specificity is 96.5%, 226 subjects who were diagnosed with SR based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject its null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms approximately 300 subjects with no known diagnosis of AF were enrolled.||||<0.0001
73947877|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|||||TWO_SIDED|95.0|5.3|13.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||13.0|5.3|
73947878|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|||||TWO_SIDED|95.0|-16.9|-9.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||-9.3|-16.9|
73947879|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|||||TWO_SIDED|95.0|-13.2|0.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||0.5|-13.2|
73947880|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.9|||||TWO_SIDED|95.0|6.6|19.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||19.2|6.6|
73947881|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.7|||||TWO_SIDED|95.0|-25.9|-13.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||-13.5|-25.9|
73947882|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.3|||||TWO_SIDED|95.0|-30.8|-2.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||-2.0|-30.8|
73947883|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|9.0|37.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||37.2|9.0|
73947884|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.4|||||TWO_SIDED|95.0|-53.2|-25.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||-25.3|-53.2|
73947885|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.5|1.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||1.6|-1.5|
73947886|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-2.9|2.4|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||2.4|-2.9|
73947887|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-4.7|3.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||3.1|-4.7|
73947888|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-8.3|4.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||4.1|-8.3|
73947889|NCT01872910|147428590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|||||TWO_SIDED|95.0|-21.4|7.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||7.6|-21.4|
73947890|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-4.2|14.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||14.5|-4.2|
73947891|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.0|||||TWO_SIDED|95.0|-41.5|-22.4|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||-22.4|-41.5|
73947892|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|27.8|46.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||46.5|27.8|
74032108|NCT02749721|147617313|OTHER||Pearson's R|-0.374||||0.105|TWO_SIDED||||||Pearson's correlation|||VGNG P3a (amplitude)||||0.105
74032109|NCT02749721|147617313|OTHER||Pearson's R|-0.137||||0.601|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-28 baseline to endpoint percent change||||0.601
74032110|NCT02749721|147617313|OTHER||Pearson's R|-0.234||||0.421|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change||||0.421
74032111|NCT02749721|147617313|OTHER||Pearson's R|0.378||||0.316|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-28 baseline to endpoint percent change||||0.316
74032112|NCT02749721|147617313|OTHER||Pearson's R|0.185||||0.478|TWO_SIDED||||||Pearson's correlation|||||||0.478
74032113|NCT02749721|147617313|OTHER||Pearson's R|0.011||||0.969|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change||||0.969
73947893|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3|||||TWO_SIDED|95.0|-2.9|17.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||17.6|-2.9|
73947894|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.1|||||TWO_SIDED|95.0|-45.6|-24.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||-24.6|-45.6|
73947895|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.5|||||TWO_SIDED|95.0|32.1|52.7|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||52.7|32.1|
73947896|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-1.0|23.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||23.0|-1.0|
73947897|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.7|||||TWO_SIDED|95.0|-45.1|-20.3|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||-20.3|-45.1|
73947898|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.5|||||TWO_SIDED|95.0|31.3|55.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||55.5|31.3|
73947899|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.4|||||TWO_SIDED|95.0|-1.6|26.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||26.2|-1.6|
73947900|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-30.2|||||TWO_SIDED|95.0|-44.0|-16.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||-16.0|-44.0|
73976837|NCT02909959|147499910|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.72|STANDARD_ERROR_OF_MEAN|3.05||0.373|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.373
73976838|NCT00853593|147499964|SUPERIORITY_OR_OTHER||One sample proportion|0.951|||||ONE_SIDED|95.0|0.906||||||The Model 4396 lead will be considered safe if the proportion of subjects free of Model 4396 lead-related complications at one month post-implant is greater than 80% (i.e. the one sided 95% lower confidence bound must be at least 80%).||||.906|
73976839|NCT00853593|147499965|SUPERIORITY_OR_OTHER||One sample mean|1.6|STANDARD_DEVIATION|1.4|||ONE_SIDED|95.0||1.8||||||||1.8||
73976840|NCT00853593|147499966|SUPERIORITY_OR_OTHER||One sample mean|2.3|STANDARD_DEVIATION|2.0|||ONE_SIDED|97.5||2.7||||||||2.7||
73947901|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.6|||||TWO_SIDED|95.0|28.6|56.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||56.5|28.6|
73947902|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|-9.7|12.9|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||12.9|-9.7|
73947903|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-9.8|16.8|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||16.8|-9.8|
73947904|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5|||||TWO_SIDED|95.0|-9.9|19.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 8 h.|||19.0|-9.9|
73947905|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-9.2|21.1|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||21.1|-9.2|
73947906|NCT01872910|147428591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-8.4|24.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||24.2|-8.4|
73947907|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.9|||||95% CrI is reported here, not the CI. Estimation is SPID 0 to 4 h.|||1.9|-0.6|
73947908|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-4.1|-1.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||-1.7|-4.1|
73947909|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|2.3|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||4.8|2.3|
73976841|NCT00853593|147499967|SUPERIORITY_OR_OTHER||One sample proportion|0.927|||||TWO_SIDED|95.0|0.887|0.967||||||||.967|.887|
73976842|NCT00853593|147499968|SUPERIORITY_OR_OTHER||One sample proportion|0.969|||||TWO_SIDED|95.0|0.944|0.993||||||||.993|.944|
73976843|NCT00853593|147499969|SUPERIORITY_OR_OTHER||One sample proportion|0.959|||||TWO_SIDED|95.0|0.93|0.987||||||||.987|.930|
73976844|NCT00853593|147499970|SUPERIORITY_OR_OTHER||One sample proportion|0.948|||||TWO_SIDED|95.0|0.917|0.979||||||||.979|.917|
73976845|NCT00853593|147499976|SUPERIORITY_OR_OTHER||One sample mean|2.4|STANDARD_DEVIATION|1.9|||ONE_SIDED|95.0||2.7||||||||2.7||
73976846|NCT03683576|147499994|SUPERIORITY||Odds Ratio (OR)|0.674||||0.1425|TWO_SIDED|95.0|0.398|1.142|||Regression, Logistic||GB001 20 mg vs. Placebo|||1.142|0.398|0.1425
73976847|NCT03683576|147499994|SUPERIORITY||Odds Ratio (OR)|0.677||||0.1482|TWO_SIDED|95.0|0.399|1.149|||Regression, Logistic||GB001 40 mg vs. Placebo|||1.149|0.399|0.1482
73976848|NCT03683576|147499994|SUPERIORITY||Odds Ratio (OR)|0.651||||0.1086|TWO_SIDED|95.0|0.385|1.1|||Regression, Logistic||GB001 60 mg vs. Placebo|||1.100|0.385|0.1086
73976849|NCT03683576|147499995|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1647|TWO_SIDED|95.0|-0.36|0.06|||ANCOVA||GB001 20 mg vs. Placebo|||0.06|-0.36|0.1647
73976850|NCT03683576|147499995|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1737|TWO_SIDED|95.0|-0.37|0.07|||ANCOVA||GB001 40 mg vs. Placebo|||0.07|-0.37|0.1737
73976851|NCT03683576|147499995|SUPERIORITY||Mean Difference (Net)|-0.19||||0.0879|TWO_SIDED|95.0|-0.4|0.03|||ANCOVA||GB001 60 mg vs. Placebo|||0.03|-0.40|0.0879
73870446|NCT04255862|147284663|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for Cmax.|Geometric Mean Ratio|114.3|||||TWO_SIDED|90.0|99.5|131.4||||||||131.4|99.5|
73870447|NCT02451917|147284701|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint(A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%.||||||0.00045||||||The intention-to-treat population consisted of all randomized participants.|ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint (A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov-Smirnov statistics) was performed at baseline for each sequence of the therapy.||||0.00045
73870448|NCT02451917|147284702|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov-Smirnov statistics) was performed at baseline for each sequence of the therapy.|number of total events per patient|0.0||||0.35|TWO_SIDED|||||Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks||||0.35
73947910|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.9|3.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||3.2|-0.9|
73947911|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|||||TWO_SIDED|95.0|-6.8|-2.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||-2.7|-6.8|
73976852|NCT03683576|147499996|SUPERIORITY||Mean Difference (Net)|0.016||||0.7718|TWO_SIDED|95.0|-0.091|0.123|||ANCOVA||GB001 20 mg vs. Placebo|||0.123|-0.091|0.7718
73870449|NCT02451917|147284702|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|number of nocturnal events per patient|0.0||||0.047|TWO_SIDED|||||Analysis of covariance (ANOVA) model - number of nocturnal hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.047
73947912|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|3.8|8.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||8.0|3.8|
73947913|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-1.0|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||4.8|-1.0|
73947914|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|||||TWO_SIDED|95.0|-9.0|-3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||-3.3|-9.0|
73947915|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|5.1|10.9|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||10.9|5.1|
73947916|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|-1.3|8.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||8.1|-1.3|
73947917|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2|||||TWO_SIDED|95.0|-12.9|-3.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||-3.5|-12.9|
73976853|NCT03683576|147499996|SUPERIORITY||Mean Difference (Net)|0.041||||0.4562|TWO_SIDED|95.0|-0.067|0.149|||ANCOVA||GB001 40 mg vs. Placebo|||0.149|-0.067|0.4562
73976854|NCT03683576|147499996|SUPERIORITY||Mean Difference (Net)|0.075||||0.1631|TWO_SIDED|95.0|-0.03|0.18|||ANCOVA||GB001 60 mg vs. Placebo|||0.180|-0.030|0.1631
73976855|NCT03683576|147499997|SUPERIORITY||Hazard Ratio (HR)|0.719||||0.0466|TWO_SIDED|95.0|0.519|0.995|||Regression, Cox||GB001 20 mg vs. Placebo|||0.995|0.519|0.0466
73976856|NCT03683576|147499997|SUPERIORITY||Hazard Ratio (HR)|0.773||||0.1222|TWO_SIDED|95.0|0.558|1.071|||Regression, Cox||GB001 40 mg vs. Placebo|||1.071|0.558|0.1222
73976857|NCT03683576|147499997|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.0304|TWO_SIDED|95.0|0.505|0.967|||Regression, Cox||GB001 60 mg vs. Placebo|||0.967|0.505|0.0304
73976858|NCT03683576|147499998|SUPERIORITY||Rate ratio|0.797||||0.3382|TWO_SIDED|95.0|0.501|1.268|||Negative binomial regression model||GB001 20 mg vs. Placebo|||1.268|0.501|0.3382
73976859|NCT03683576|147499998|SUPERIORITY||Rate ratio|0.748||||0.2248|TWO_SIDED|95.0|0.469|1.195|||Negative binomial regression model||GB001 40 mg vs. Placebo|||1.195|0.469|0.2248
73976860|NCT03683576|147499998|SUPERIORITY||Rate ratio|0.889||||0.609|TWO_SIDED|95.0|0.565|1.397|||Negative binomial regression model||GB001 60 mg vs. Placebo|||1.397|0.565|0.6090
73976861|NCT03683576|147499999|SUPERIORITY||Mean Difference (Net)|-0.023||||0.6645|TWO_SIDED|95.0|-0.127|0.081|||ANCOVA||GB001 20 mg vs. Placebo|||0.081|-0.127|0.6645
73870450|NCT02451917|147284703|NON_INFERIORITY_OR_EQUIVALENCE|t-test was applied to compare percentages of the time spent in hypoglycemia, hyperglycemia and euglycemia on CGM readings.|||||<|0.05|||||||t-test, 1 sided|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||<0.05
73870451|NCT02451917|147284704|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.668|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.668
73870452|NCT02451917|147284705|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.999
73947918|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|7.0|16.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||16.5|7.0|
73947919|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-2.6|18.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||18.3|-2.6|
73976862|NCT03683576|147499999|SUPERIORITY||Mean Difference (Net)|0.035||||0.5288|TWO_SIDED|95.0|-0.074|0.144|||ANCOVA||GB001 40 mg vs. Placebo|||0.144|-0.074|0.5288
73947920|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-24.7|-3.6|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||-3.6|-24.7|
73947921|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.9|||||TWO_SIDED|95.0|11.5|32.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||32.2|11.5|
73947922|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.6|1.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||1.0|-1.6|
73947923|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.2|2.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||2.1|-2.2|
73947924|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-2.9|3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||3.3|-2.9|
73947925|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-3.9|5.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||5.7|-3.9|
73947926|NCT01872910|147428592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.1|||||TWO_SIDED|95.0|-6.8|15.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||15.0|-6.8|
73947927|NCT01872910|147428593|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.85|||||TWO_SIDED|95.0|0.99|3.46|||||Hazard ratio (HR) of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||3.46|0.99|
73976863|NCT03683576|147499999|SUPERIORITY||Mean Difference (Net)|0.079||||0.1362|TWO_SIDED|95.0|-0.025|0.182|||ANCOVA||GB001 60 mg vs. Placebo|||0.182|-0.025|0.1362
73976864|NCT03683576|147500000|SUPERIORITY||Mean Difference (Net)|6.122||||0.3957|TWO_SIDED|95.0|-8.007|20.251|||ANCOVA||GB001 20 mg vs. Placebo|||20.251|-8.007|0.3957
73976865|NCT03683576|147500000|SUPERIORITY||Mean Difference (Net)|13.948||||0.0598|TWO_SIDED|95.0|-0.578|28.474|||ANCOVA||GB001 40 mg vs. Placebo|||28.474|-0.578|0.0598
73976866|NCT03683576|147500000|SUPERIORITY||Mean Difference (Net)|5.588||||0.4376|TWO_SIDED|95.0|-8.522|19.698|||ANCOVA||GB001 60 mg vs. Placebo|||19.698|-8.522|0.4376
73976867|NCT01701401|147500049|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
73976868|NCT01701401|147500049|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
73976869|NCT01701401|147500049|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
73976870|NCT01701401|147500049|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
73976871|NCT05325294|147500076|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.1||||0.133|TWO_SIDED|95.0|-0.2|0.1|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||0.1|-0.2|0.133
74032114|NCT02749721|147617313|OTHER||Pearson's R|-0.018||||0.943|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-17 baseline scores||||0.943
73947928|NCT01872910|147428593|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.34|||||TWO_SIDED|95.0|0.16|0.72|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.72|0.16|
73947929|NCT01872910|147428593|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|5.48|||||TWO_SIDED|95.0|2.69|11.16|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||11.16|2.69|
73947930|NCT01872910|147428593|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.57|2.59|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||2.59|0.57|
73947931|NCT01872910|147428594|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.78|||||TWO_SIDED|95.0|0.41|1.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||1.47|0.41|
73947932|NCT01872910|147428594|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|2.15|||||TWO_SIDED|95.0|1.19|3.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||3.88|1.19|
73947933|NCT01872910|147428594|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.36|||||TWO_SIDED|95.0|0.19|0.67|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.67|0.19|
73947934|NCT01872910|147428595|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.33|||||TWO_SIDED|95.0|0.12|0.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.88|0.12|
73947935|NCT01872910|147428595|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|4.16|||||TWO_SIDED|95.0|2.04|8.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||8.47|2.04|
73947936|NCT01872910|147428595|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.08|||||TWO_SIDED|95.0|0.03|0.21|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.21|0.03|
73947937|NCT01616771|147428601|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||To verify the difference in C\&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges-Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C\&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C\&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.||||<0.05
73947938|NCT01616771|147428602|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||To verify the difference in C\&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges-Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C\&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C\&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.||||<0.05
73947939|NCT02387216|147428615|SUPERIORITY||Hazard Ratio (HR)|1.382||||0.2302|TWO_SIDED|95.0|0.813|2.35|||Log Rank|||||2.350|0.813|0.2302
73947940|NCT02387216|147428616|SUPERIORITY||Hazard Ratio (HR)|1.195||||0.5436|TWO_SIDED|95.0|0.673|2.122|||Log Rank|||||2.122|0.673|0.5436
73947941|NCT02387216|147428617|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0455|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0455
73947942|NCT02387216|147428618|SUPERIORITY|||||||0.2726|||||||Log Rank|||||||0.2726
73947943|NCT05952297|147428635|SUPERIORITY|||||||0.88|||||||mixed model|linear mixed model, time x condition effect||||||.88
73947944|NCT03107377|147428638|SUPERIORITY||Risk Difference (RD)|-4.81||||0.0256|TWO_SIDED|95.0|-9.02|-0.61|||Chi-squared|||||-0.61|-9.02|0.0256
73976872|NCT05325294|147500076|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.5% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.3|-0.6|<0.001
73976873|NCT05325294|147500077|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 65.3% with a margin of -7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|68.6|||<|0.001|TWO_SIDED|95.0|66.6|70.7|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||70.7|66.6|<0.001
73976874|NCT05325294|147500077|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 73.7% with a margin of -7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.6|||<|0.001|TWO_SIDED|95.0|75.7|79.4|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||79.4|75.7|<0.001
73976875|NCT05325294|147500078|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL) will be estimated and compared to a threshold of 0.71% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.5|0.3|<0.001
73947945|NCT03107377|147428639|SUPERIORITY||Risk Difference (RD)|-2.53||||0.0316|TWO_SIDED|95.0|-4.84|-0.23|||Chi-squared|||||-0.23|-4.84|0.0316
73947946|NCT03107377|147428643|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =0% adherence||||1.0000
73947947|NCT03107377|147428643|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>0% adherence||||1.0000
73947948|NCT03107377|147428643|SUPERIORITY|||||||0.6278|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=20% adherence||||.6278
73947949|NCT03107377|147428643|SUPERIORITY|||||||0.6404|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=40% adherence||||.6404
73947950|NCT03107377|147428643|SUPERIORITY|||||||0.5008|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=60% adherence||||.5008
73947951|NCT03107377|147428643|SUPERIORITY|||||||0.1818|||||||Chi-squared|||A comparison of infection rates between the treatment arms amongst subjects with \>=80% adherence||||.1818
73947952|NCT03107377|147428643|SUPERIORITY|||||||0.0012|||||||Chi-squared|||A comparison of infection rates between the treatment arms amongst subjects with =100% adherence||||0.0012
73947953|NCT03107377|147428644|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =0% adherence||||1.0000
73947954|NCT03107377|147428644|SUPERIORITY|||||||0.4375|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>0% adherence||||0.4375
73947955|NCT03107377|147428644|SUPERIORITY|||||||0.4444|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=20% adherence||||0.4444
73947956|NCT03107377|147428644|SUPERIORITY|||||||0.1836|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=60% adherence||||0.1836
73947957|NCT03107377|147428644|SUPERIORITY|||||||0.5006|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=80% adherence||||0.5006
73947958|NCT03107377|147428644|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =100% adherence||||1.000
73947959|NCT04078035|147428681|SUPERIORITY||Slope|-0.00015|STANDARD_ERROR_OF_MEAN|0.00088||0.86|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.86
73870453|NCT02451917|147284706|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.999
73947960|NCT04078035|147428682|SUPERIORITY||Slope|0.00022|STANDARD_ERROR_OF_MEAN|0.00067||0.74|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results present the condition (stress/control) by time interactions.||||0.74
73947961|NCT04078035|147428683|SUPERIORITY||Slope|-0.0012|STANDARD_ERROR_OF_MEAN|0.0019||0.52|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.52
73947962|NCT04078035|147428684|SUPERIORITY|Results present the condition (stress/control) by time\^2 interactions.|Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 77.2, p \< .001.||||||<.001
73947963|NCT04078035|147428685|SUPERIORITY||Slope|0.0021|STANDARD_ERROR_OF_MEAN|0.00027|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 66.4, p \< .001.||Results-interaction between time2 and condition||||<.001
73947964|NCT04078035|147428686|SUPERIORITY||Slope|0.0013|STANDARD_ERROR_OF_MEAN|0.0002|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 77.2, p \< .001.||Results-interaction between time\^2 and condition||||<.001
73947965|NCT04078035|147428687|SUPERIORITY||Slope|0.0037|STANDARD_ERROR_OF_MEAN|0.0013||0.005|TWO_SIDED||||||Mixed Models Analysis|||Results below present the condition (stress/control) by time interactions.||||0.005
73947966|NCT04078035|147428688|SUPERIORITY||Slope|-0.0071|STANDARD_ERROR_OF_MEAN|0.074||0.92|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.92
73976876|NCT05325294|147500078|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL) will be estimated and compared to a threshold of 0.86% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.2|||<|0.001|TWO_SIDED|95.0|0.2|0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.3|0.2|<0.001
73976877|NCT05325294|147500079|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 65.3% and a significance level of 0.025 (one-sided).|Mean of Final Value|68.6|||<|0.001|TWO_SIDED|95.0|66.6|70.7|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||70.7|66.6|<0.001
73947967|NCT04078035|147428689|SUPERIORITY||Slope|-0.85|STANDARD_ERROR_OF_MEAN|0.41||0.04|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.04
73947968|NCT04078035|147428690|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.0033||0.002|TWO_SIDED|||||Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.|Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 15.64, p \< .001.||Results-interaction between time\^2 and condition||||0.002
73947969|NCT04078035|147428691|SUPERIORITY||Slope|0.014|STANDARD_ERROR_OF_MEAN|0.0053||0.008|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results \_condition (stress/control) by time interactions.||||0.008
73976878|NCT05325294|147500079|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 73.7% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.6|||<|0.001|TWO_SIDED|95.0|75.7|79.4|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||79.4|75.7|<0.001
73870454|NCT02451917|147284707|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.994|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.994
73947970|NCT04078035|147428692|SUPERIORITY||Slope|-0.0003|STANDARD_ERROR_OF_MEAN|0.0014||0.83|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.83
73947971|NCT04078035|147428693|SUPERIORITY||Slope|-0.0074|STANDARD_ERROR_OF_MEAN|0.0033||0.03|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.03
73947972|NCT04078035|147428694|SUPERIORITY||Slope|0.00075|STANDARD_ERROR_OF_MEAN|0.00012||0.51|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.51
73947973|NCT04078035|147428695|SUPERIORITY||Slope|-0.0053|STANDARD_ERROR_OF_MEAN|0.0026||0.04|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.04
73947974|NCT04078035|147428696|SUPERIORITY||Slope|0.0018|STANDARD_ERROR_OF_MEAN|0.0027||0.49|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.49
74089272|NCT02697773|147731611|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0006|TWO_SIDED|95.0|1.38|3.27|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.27|1.38|0.0006
73870455|NCT04737278|147284713|OTHER|test of the hypothesis that the score on day 28 is different from the baseline score in the Placebo group|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73947975|NCT04078035|147428697|SUPERIORITY||Slope|0.013|STANDARD_ERROR_OF_MEAN|0.0044||0.002|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.002
73947976|NCT02100722|147428699|NON_INFERIORITY|Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio.|Hazard Ratio (HR)|1.5||||0.35|TWO_SIDED|95.0|1.1|2.2|||Regression, Cox|||A sample of 712 patients per group (1424 for the entire trial) would be required in order to achieve 90% power to claim noninferiority||2.2|1.1|0.35
73947977|NCT02100722|147428702|OTHER||Hazard Ratio (HR)|1.7|||||TWO_SIDED|95.0|0.7|4.3||||||||4.3|0.7|
73947978|NCT02100722|147428703|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.9|2.5|||||Hazard ratio for overall number of participants experiencing MI.|||2.5|0.9|
73947979|NCT02100722|147428704|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.4||||||||2.4|0.3|
73947980|NCT02100722|147428705|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.9|2.3|||||Hazard ratio for overall number of participants experiencing repeat revascularization.|||2.3|0.9|
73947981|NCT02100722|147428706|OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
73947982|NCT02100722|147428707|OTHER||||||<|0.04|||||||Fisher Exact|||||||<0.04
73947983|NCT02100722|147428708|OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
73947984|NCT02100722|147428711|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73947985|NCT02541383|147428794|SUPERIORITY||Odds Ratio (OR)|1.6||||0.001|TWO_SIDED|95.0|1.21|2.12|||Cochran-Mantel-Haenszel|||||2.12|1.21|0.0010
73947986|NCT02541383|147428795|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.42|0.68|||Log Rank|||||0.68|0.42|<0.0001
74089273|NCT02697773|147731611|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1139|TWO_SIDED|95.0|0.92|2.07|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.07|0.92|0.1139
73870456|NCT04737278|147284713|OTHER|||||||0.01|||||||t-test, 2 sided|||test of the hypothesis that the score on day 28 is different than the baseline score||||0.01
73870457|NCT04737278|147284714|OTHER|||||||0.15|||||||t-test, 2 sided|||Day 28. Between group comparison was made using ANCOVA accounting for baseline values, no significance at p\<0.05. Within group comparisons were made using the paired Student's t test.||||0.15
73870458|NCT04737278|147284715|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
73870459|NCT04737278|147284715|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||comparison made between placebo and Cunermuspir at baseline||||0.03
73947987|NCT02541383|147428796|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.52|0.72|||Log Rank|||||0.72|0.52|<0.0001
73947988|NCT02066896|147428800|OTHER|ANOVA repeated measures||||||0.05|||||||ANOVA|ANOVA repeated measures||||||0.05
73947989|NCT01065350|147428811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.87|||<|0.001|TWO_SIDED|95.0|2.07|26.15||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 5 minutes post induction was compared between treatment groups.||26.15|2.07|<0.001
73947990|NCT01065350|147428811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.01|TWO_SIDED|95.0|1.21|8.75||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 10 minutes post induction was compared between treatment groups.||8.75|1.21|<0.01
73947991|NCT01065350|147428811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.39|TWO_SIDED|95.0|0.52|4.55||A p value of \< 0.005 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 30 minutes post induction was compared between treatment groups||4.55|0.52|0.39
73947992|NCT01065350|147428812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.64|||<|0.01|TWO_SIDED|95.0|1.54|14.92||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 5 minutes post induction was compared between treatment groups.||14.92|1.54|<0.01
73947993|NCT01065350|147428812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.05|TWO_SIDED|95.0|0.91|6.29||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 10 minutes post induction was compared between treatment groups.||6.29|0.91|0.05
73947994|NCT01065350|147428812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.11|TWO_SIDED|95.0|0.68|13.19||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 30 minutes post induction was compared between treatment groups.||13.19|0.68|0.11
73947995|NCT01065350|147428813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.12|||<|0.001|TWO_SIDED|95.0|1.98|31.64||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.||31.64|1.98|<0.001
73947996|NCT01065350|147428813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.02|TWO_SIDED|95.0|1.07|7.65||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 10 minutes post induction was compared between treatment groups.||7.65|1.07|0.02
73947997|NCT01065350|147428813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.33|TWO_SIDED|95.0|0.51|5.97||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 30 minutes post induction was compared between treatment groups.||5.97|0.51|0.33
73976879|NCT00378898|147500107|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
73947998|NCT01065350|147428814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.19|TWO_SIDED|95.0|-0.1|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 5 minutes post induction was compared between treatment groups.||0.5|-0.1|0.19
73947999|NCT01065350|147428814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.6|TWO_SIDED|95.0|-0.3|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 10 minutes post induction was compared between treatment groups.||0.5|-0.3|0.6
73948000|NCT01065350|147428815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.26|TWO_SIDED|95.0|-0.1|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 5 minutes post induction was compared between treatment groups.||0.3|-0.1|0.26
73948001|NCT01065350|147428815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.71|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.||0.3|-0.2|0.71
73948002|NCT01065350|147428816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.61|TWO_SIDED|95.0|-2.9|1.7|||t-test, 2 sided|||Average heart rate from baseline to 5 minutes post induction was compared between treatment groups.||1.7|-2.9|0.61
73948003|NCT01065350|147428816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.22|TWO_SIDED|95.0|-4.8|1.1|||t-test, 2 sided|||Average heart rate from baseline to 10 minutes post induction was compared between treatment groups.||1.1|-4.8|0.22
73948004|NCT01065350|147428817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.7|||<|0.001|TWO_SIDED|95.0|7.5|20.0|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.||20.0|7.5|<0.001
73948005|NCT01065350|147428817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8||||0.017|TWO_SIDED|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.||9.5|0.2|0.017
73948006|NCT01065350|147428818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||<|0.01|TWO_SIDED|95.0|2.7|11.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.||11.5|2.7|<0.01
73948007|NCT01065350|147428818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.042|TWO_SIDED|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.||9.5|0.2|0.042
73948008|NCT01065350|147428819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|||<|0.001|TWO_SIDED|95.0|4.8|13.9|||t-test, 2 sided|||Average change in Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.||13.9|4.8|<0.001
73948009|NCT01065350|147428819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.013|TWO_SIDED|95.0|1.4|11.3|||t-test, 2 sided|||Average change in Mean Arterial Pressure from baseline to 10 minutes post induction was compared between treatment groups.||11.3|1.4|0.013
73948010|NCT01065350|147428820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.6|||<|0.01|TWO_SIDED|95.0|28.1|199.1|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 5 minutes post induction was compared between treatment groups.||199.1|28.1|<0.01
73948011|NCT01065350|147428820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.8||||0.12|TWO_SIDED|95.0|-21.7|195.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 10 minutes post induction was compared between treatment groups.||195.3|-21.7|0.12
73948012|NCT01065350|147428821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|182.6||||0.017|TWO_SIDED|95.0|33.8|331.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 5 minutes post induction was compared between treatment groups.||331.3|33.8|0.017
73948013|NCT01065350|147428821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|128.7||||0.17|TWO_SIDED|95.0|-58.1|315.5|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 10 minutes post induction was compared between treatment groups.||315.5|-58.1|0.17
73948014|NCT01065350|147428822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.029|TWO_SIDED|95.0|0.5|8.4|||t-test, 2 sided|||Average change in Stroke Volume (SV) from baseline to 5 minutes post induction was compared between treatment groups.||8.4|0.5|0.029
73948015|NCT01065350|147428822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.051|TWO_SIDED|95.0|0.0|9.7|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.||9.7|-0.0|0.051
73948016|NCT01065350|147428823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.027|TWO_SIDED|95.0|0.3|4.7|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 5 minutes post induction was compared between treatment groups.||4.7|0.3|0.027
73948017|NCT01065350|147428823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.052|TWO_SIDED|95.0|0.0|5.2|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 10 minutes post induction was compared between treatment groups.||5.2|-0.0|0.052
73948018|NCT01065350|147428824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.44|TWO_SIDED|95.0|-1.4|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 5 minutes post induction was compared between treatment groups.||0.6|-1.4|0.44
73948019|NCT01065350|147428824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.37|TWO_SIDED|95.0|-1.6|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 10 minutes post induction was compared between treatment groups.||0.6|-1.6|0.37
73948020|NCT01373450|147428825|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.87||||0.024|TWO_SIDED|90.0|0.77|0.98|||t-test, 1 sided|||||0.98|0.77|0.024
73948021|NCT01373450|147428826|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77||||0.004|TWO_SIDED|90.0|0.66|0.9|||t-test, 1 sided|||||0.90|0.66|0.004
73948022|NCT01373450|147428827|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.014|||<|0.001|TWO_SIDED|90.0|0.008|0.019|||t-test, 1 sided|||||0.019|0.008|<0.001
73948023|NCT01373450|147428828|SUPERIORITY_OR_OTHER||Intraclass Correlation Coefficient|0.92|||||TWO_SIDED|90.0|0.72|0.98||||||||0.98|0.72|
73948024|NCT01373450|147428829|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77||||0.003|TWO_SIDED|90.0|0.66|0.9|||t-test, 1 sided|||||0.90|0.66|0.003
73948025|NCT01373450|147428829|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.58|||<|0.001|TWO_SIDED|90.0|0.45|0.74|||t-test, 1 sided|||||0.74|0.45|<0.001
73948026|NCT01373450|147428829|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99||||0.473|TWO_SIDED|90.0|0.85|1.16|||t-test, 1 sided|||||1.16|0.85|0.473
73948027|NCT01373450|147428829|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.75||||0.049|TWO_SIDED|90.0|0.56|1.0|||t-test, 1 sided|||||1.00|0.56|0.049
73948028|NCT01373450|147428830|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.021|||<|0.001|TWO_SIDED|90.0|0.015|0.026|||t-test, 1 sided|||||0.026|0.015|<0.001
73948029|NCT01373450|147428830|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.03|||<|0.001|TWO_SIDED|90.0|0.021|0.038|||t-test, 1 sided|||||0.038|0.021|<0.001
73948030|NCT01373450|147428830|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.007||||0.0163|TWO_SIDED|90.0|0.002|0.012|||t-test, 1 sided|||||0.012|0.002|0.0163
73948031|NCT01373450|147428830|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.016||||0.0056|TWO_SIDED|90.0|0.006|0.026|||t-test, 1 sided|||||0.026|0.006|0.0056
73948032|NCT00510458|147428831|OTHER|It is expected that the mean linear wear rate is not more than 0.08 mm per year or 0.05 mm per year superior to the reference control, which was 0.13 mm per year. The reference control was determined from the control group within the Post-approval Study of the ABC and Trident® Systems (NCT00960206).|mean linear wear rate at 5 yrs|0.008|||||TWO_SIDED|90.0|-0.0107|0.0267||||||||.0267|-0.0107|
73948033|NCT00510458|147428832|OTHER|To test if the change from pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73948034|NCT00510458|147428833|OTHER|To test if the change from pre-operative HHS pain score compared to the post-operative HHS pain score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73948035|NCT00510458|147428834|OTHER|To test if the change from pre-operative HHS ROM compared to the post-operative HHS ROM at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73948036|NCT00510458|147428835|OTHER|To test if the change from pre-operative SF-12 Physical component score compared to the post-operative SF-12 Physical component score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73976880|NCT01256359|147500111|SUPERIORITY||Hazard Ratio (HR)|0.753||||0.13|TWO_SIDED|90.0|0.498|1.138||p value \< 0.1 one-sided considered to be significant.|Regression, Cox||HR is Adjusted for M status, performance status|||1.138|0.498|0.130
73976881|NCT01256359|147500111|SUPERIORITY||Hazard Ratio (HR)|0.723||||0.113|TWO_SIDED|90.0|0.465|1.123|||Regression, Cox||This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status|This is a sensitivity analysis of the primary outcome. This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status||1.123|0.465|0.113
74032115|NCT02749721|147617313|OTHER||Pearson's R|-0.074||||0.795|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-17 baseline scores||||0.795
74032116|NCT02749721|147617313|OTHER||Pearson's R|-0.011||||0.969|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-17 baseline scores||||0.969
73948037|NCT00510458|147428835|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 1 year is statistically significant.||||||0.0394|||||||t-test, 2 sided|||||||0.0394
73948038|NCT00510458|147428835|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 3 years is statistically significant.||||||0.4974|||||||t-test, 2 sided|||||||0.4974
73870460|NCT04737278|147284715|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||comparison made at day 28||||0.01
73948039|NCT00510458|147428835|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 5 years is statistically significant.||||||0.677|||||||t-test, 2 sided|||||||0.6770
73948040|NCT00510458|147428836|OTHER|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 1 year and 3 years is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73948041|NCT00510458|147428836|OTHER|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 5 years is statistically significant.||||||0.0006|||||||t-test, 2 sided|||||||0.0006
73948042|NCT03573908|147428885|SUPERIORITY||Least squares (LS) mean difference|-0.715|||<|0.0001|TWO_SIDED|95.0|-0.998|-0.433|||MMRM||Least squares (LS) mean difference (linaclotide - placebo)|The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.433|-0.998|< 0.0001
73948043|NCT03573908|147428886|SUPERIORITY||Hodges-Lehman Estimated Median Threshold|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.88|-0.35|||Wilcoxon Rank Sum Test|P-value comparing change from baseline distributions by treatment using the Wilcoxon rank sum test 2-sided.|95% confidence interval (CI) for Hodges-Lehmann estimated median threshold was generated by Moses confidence limits method.|The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.35|-0.88|< 0.0001
73948044|NCT03573908|147428887|SUPERIORITY||Difference in Responder Rate|17.1|||||TWO_SIDED|95.0|9.9|24.4|||||95% confidence intervals for difference in responder rate are obtained using the normal approximation to the binomial distribution.|||24.4|9.9|
73948045|NCT03573908|147428887|SUPERIORITY||Odds Ratio (OR)|2.2|||<|0.0001|TWO_SIDED|95.0|1.55|3.12||Odds ratio, 95% CI for the Odds Ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for geographic region.|Cochran-Mantel-Haenszel|||The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||3.12|1.55|< 0.0001
73976882|NCT01256359|147500111|SUPERIORITY|||||||0.3016||||||This analysis assesses if allowing for interval censoring is consistent with the primary outcome results.|Generalised log-rank|Generalised log-rank taking into account interval censoring, analysed using SAS package version 9.2. Method by Zhao and Sun, 2004||This is a sensitivity analysis, including all 83 randomised patients. Patients are assessed periodically for the response (progression), the time when the event occurred is not directly observed but is known to take place within some time interval. Progression is known only to have occurred at some time between visits, the exact time is not known. We carried out interval censored analysis to demonstrate if allowing for interval censoring gives a different interpretation of the primary outcome.||||0.3016
73976883|NCT01256359|147500111|SUPERIORITY||Hazard Ratio (HR)|1.348||||0.305|TWO_SIDED|90.0|0.602|3.016|||Regression, Cox||Adjusted for centre|Sensitivity analysis adjusting for centre. All 83 randomised patients were included in analysis. Centres were the three biggest recruiters and all other 13 centres are combined.||3.016|0.602|0.305
73976884|NCT01256359|147500112|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.187|TWO_SIDED|90.0|-3.4|31.4|||Log Rank||This is the estimated difference in PFS rate i.e. % difference between arms|||31.4|-3.4|0.187
73976885|NCT01256359|147500113|SUPERIORITY||Hazard Ratio (HR)|1.373||||0.169|TWO_SIDED|90.0|0.797|2.369|||Regression, Cox|p value \< 0.1 one-sided considered to be significant.||||2.369|0.797|0.169
73976886|NCT01256359|147500114|SUPERIORITY|||||||0.059|||||||Chi-squared|||Objective response rate calculated as number of patients with CR or PR over all patients randomised.||||0.059
73976887|NCT01256359|147500115|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.318|TWO_SIDED|90.0|0.71|1.84|||Regression, Cox|||Analysis adjusted for with Mstatus and Performance Score||1.84|0.71|0.318
73976888|NCT01256359|147500153|SUPERIORITY||Hazard Ratio (HR)|1.022||||0.468|TWO_SIDED|90.0|0.649|1.612|||Regression, Cox||Analysis Adjusted for M status, performance status|This is a sensitivity analysis of the primary outcome.||1.612|0.649|0.468
73976889|NCT01256359|147500154|SUPERIORITY||Hazard Ratio (HR)|0.721||||0.106|TWO_SIDED|90.0|0.468|1.109|||Regression, Cox||Analysis was adjusted for mstatus, performance status|This is the per-protocol analysis of the primary outcome.||1.109|0.468|0.106
73976890|NCT01256359|147500155|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.824|TWO_SIDED|95.0|0.25|1.53||p-value is for the interaction term|Regression, Cox||HRs (95% CI) between treatment groups are given for Wild type and NRAS mutated separately. The above HR is for WT.|Model with interaction term between NRAS status and treatment group and stratification variables||1.53|0.25|0.824
73976891|NCT01256359|147500156|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.072|TWO_SIDED|95.0|0.16|1.6||p-value is for interaction term.|Regression, Cox|Model includes interaction term between NRAS status and treatment group and stratification variables|"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.60|0.16|0.072
73976892|NCT01256359|147500156|SUPERIORITY||Hazard Ratio (HR)|1.97|||||TWO_SIDED|95.0|0.73|5.33|||||HR for NRAS mutated patients|||5.33|0.73|
73976893|NCT01256359|147500158|SUPERIORITY|Adjusted for with Mstatus and Performance Score|Hazard Ratio (HR)|1.12||||0.348|TWO_SIDED|90.0|0.68|1.87|||Regression, Cox|||||1.87|0.68|0.348
73976894|NCT01256359|147500159|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.797|TWO_SIDED|90.0|0.24|1.58||p-value is for interaction term.|Regression, Cox|Model includes interaction term between NRAS status and treatment group and stratification variables|"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.58|0.24|0.797
73976895|NCT01256359|147500159|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.35|1.45|||||HR for NRAS mutated patients|||1.45|0.350|
73976896|NCT01256359|147500160|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.12|TWO_SIDED|95.0|0.18|1.97||Model includes interaction term between NRAS status and treatment group and stratification variables. p-value is for interaction term.|Regression, Cox||"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.97|0.18|0.120
73976897|NCT01256359|147500160|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|0.73|5.38|||||HR for NRAS mutated patients|||5.38|0.73|
73976898|NCT01429454|147500162|SUPERIORITY||Cox Proportional Hazard|0.36||||0.51|TWO_SIDED||||||Chi-squared|||||||.51
73976899|NCT01429454|147500163|SUPERIORITY||||||>|0.1|||||||Mixed Models Analysis|||||||>0.10
73976900|NCT00229970|147500219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.022||95.0|0.01|0.16|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.||||0.16|0.01|0.022
73976901|NCT00229970|147500219|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||<|0.001||95.0|0.09|0.24|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.||||0.24|0.09|<0.001
73976902|NCT00853580|147500220|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
73976903|NCT00853580|147500221|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
73976904|NCT00853580|147500222|SUPERIORITY|||||||0.86|||||||ANCOVA|||||||0.86
73976905|NCT00853580|147500223|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
73976906|NCT00853580|147500224|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
73976907|NCT00853580|147500225|SUPERIORITY|||||||0.99|||||||ANCOVA|||||||0.99
73976908|NCT00853580|147500226|SUPERIORITY|||||||0.9|||||||ANCOVA|||||||0.90
73976909|NCT00853580|147500227|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
73976910|NCT00853580|147500228|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||0.49
73976911|NCT00853580|147500229|SUPERIORITY|||||||0.86|||||||ANCOVA|||||||0.86
73976912|NCT00853580|147500230|SUPERIORITY|||||||0.09|||||||ANCOVA|||||||0.09
73976913|NCT00853580|147500231|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
73976914|NCT00853580|147500232|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
73976915|NCT00853580|147500233|SUPERIORITY|||||||0.88|||||||ANCOVA|||||||0.88
73948046|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.867|||<|0.0001|TWO_SIDED|95.0|-1.219|-0.515||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 12. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.515|-1.219|< 0.0001
73948047|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.719|||<|0.0001|TWO_SIDED|95.0|-1.062|-0.376||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 10. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.376|-1.062|< 0.0001
73948048|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.665||||0.0002|TWO_SIDED|95.0|-1.007|-0.322||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 8. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.322|-1.007|0.0002
73948049|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.831|||<|0.0001|TWO_SIDED|95.0|-1.151|-0.511||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 6. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.511|-1.151|< 0.0001
73870461|NCT04737278|147284715|OTHER|||||||0.07|||||||t-test, 2 sided|||comparison between baseline and day 28||||0.07
73870462|NCT04737278|147284716|OTHER|||||||0.54|||||||Fisher Exact|||base line between group comparisons||||0.54
73870463|NCT04737278|147284716|OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
73948050|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.683|||<|0.0001|TWO_SIDED|95.0|-0.982|-0.383||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 4. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.383|-0.982|< 0.0001
73948051|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.628|||<|0.0001|TWO_SIDED|95.0|-0.888|-0.368||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 2. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.368|-0.888|< 0.0001
73948052|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.435|||<|0.0001|TWO_SIDED|95.0|-0.641|-0.228||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 1. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.228|-0.641|< 0.0001
73948053|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.683|||<|0.0001|TWO_SIDED|95.0|-0.969|-0.398||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 3. Not part of the fixed-sequence testing procedure.||-0.398|-0.969|< 0.0001
73948054|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.768|||<|0.0001|TWO_SIDED|95.0|-1.076|-0.46||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 5. Not part of the fixed-sequence testing procedure.||-0.460|-1.076|< 0.0001
73976916|NCT00853580|147500234|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||0.25
73976917|NCT00853580|147500235|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.20
73976918|NCT00853580|147500236|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||0.50
73976919|NCT00853580|147500237|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
74032117|NCT02749721|147617313|OTHER||Pearson's R|-0.197||||0.406|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and HDRS-17 baseline scores||||0.406
73948055|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.758|||<|0.0001|TWO_SIDED|95.0|-1.086|-0.431||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 7. Not part of the fixed-sequence testing procedure.||-0.431|-1.086|< 0.0001
74032118|NCT02749721|147617313|OTHER||Pearson's R|-0.309||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and HDRS-17 baseline scores||||0.185
73870464|NCT04737278|147284717|OTHER|||||||0.54|||||||ANCOVA|||||||0.54
73948056|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.703|||<|0.0001|TWO_SIDED|95.0|-1.043|-0.363||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 9. Not part of the fixed-sequence testing procedure.||-0.363|-1.043|< 0.0001
73948057|NCT03573908|147428888|SUPERIORITY||LS mean difference|-0.844|||<|0.0001|TWO_SIDED|95.0|-1.189|-0.498||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 11. Not part of the fixed-sequence testing procedure.||-0.498|-1.189|< 0.0001
73948058|NCT04006925|147428889|OTHER||Median Difference (Net)|-23.5||||0.03|TWO_SIDED|95.0|-41.0|-2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||-2.0|-41.0|0.03
73948059|NCT04006925|147428889|OTHER||Median Difference (Net)|-9.0||||0.11|TWO_SIDED|95.0|-21.5|0.0|||Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||0.0|-21.5|0.11
73948060|NCT04006925|147428889|SUPERIORITY||Median Difference (Net)|-14.5||||0.27|TWO_SIDED|95.0|-32.0|11.3||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||11.3|-32.0|0.27
73948061|NCT04006925|147428890|OTHER||Median Difference (Net)|-1.0||||0.02|TWO_SIDED|95.0|-3.0|0.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||0.0|-3.0|0.02
73948062|NCT04006925|147428890|OTHER||Median Difference (Net)|0.0||||0.83|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||1.0|-1.0|0.83
73948063|NCT04006925|147428890|SUPERIORITY||Median Difference (Net)|-1.0||||0.09|TWO_SIDED|95.0|-3.5|0.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||0.0|-3.5|0.09
73948064|NCT04006925|147428891|SUPERIORITY|||||||0.08||||||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||||0.08
73948065|NCT04006925|147428892|SUPERIORITY|||||||0.18||||||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||||0.18
73948066|NCT04006925|147428893|OTHER||Median Difference (Net)|-1.0||||0.26|TWO_SIDED|95.0|-7.0|2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||2.0|-7.0|0.26
73948067|NCT04006925|147428893|OTHER||Median Difference (Final Values)|-0.5||||0.43|TWO_SIDED|95.0|-3.5|2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||2.0|-3.5|0.43
73948068|NCT04006925|147428893|SUPERIORITY||Median Difference (Final Values)|-0.5||||0.65|TWO_SIDED|95.0|-4.0|3.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||3.0|-4.0|0.65
73948069|NCT04006925|147428894|OTHER||Mean Difference (Net)|-6.2||||0.23|TWO_SIDED|95.0|-15.2|1.7||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Unpaired T-test|||Within group analysis of change from baseline.||1.7|-15.2|0.23
73948070|NCT04006925|147428894|OTHER||Mean Difference (Net)|0.2||||0.95|TWO_SIDED|95.0|-4.6|4.5||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Unpaired T-test|||Within group analysis of change from baseline.||4.5|-4.6|0.95
73948071|NCT04006925|147428894|SUPERIORITY||Mean Difference (Net)|-6.4||||0.22|TWO_SIDED|95.0|-16.2|3.1||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Paired T-test|||Between group analysis of change from baseline.||3.1|-16.2|0.22
73948072|NCT01755143|147428896|SUPERIORITY_OR_OTHER||Percentage|100.0|||<|0.0001|ONE_SIDED|97.5|97.7|||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication-free rate between the MRI scan and one-month post-MRI \<90%.|||97.7|<0.0001
73948073|NCT01755143|147428897|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|0.0|||||TWO_SIDED|||||A priori threshold for statistical significance was 0.025. Because there were no failures in either group, a p-value could not be calculated.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||||
73948074|NCT01755143|147428898|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|-0.7|||<|0.0001|TWO_SIDED|95.0|-5.4|4.1||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||4.1|-5.4|<0.0001
73948075|NCT01755143|147428899|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|1.6|||<|0.0001|ONE_SIDED|95.0|-3.2|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-3.2|<0.0001
73976920|NCT00853580|147500238|SUPERIORITY|||||||0.3|||||||ANCOVA|||||||0.30
73976921|NCT00853580|147500239|SUPERIORITY|||||||0.73|||||||ANCOVA|||||||0.73
73976922|NCT01700205|147500240|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.018|||<|0.05|TWO_SIDED|95.0|-0.0363|-0.0002|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction.||||-0.0002|-0.0363|<0.05
73976923|NCT01700205|147500241|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos). We provide below the parameter estimates for WLZ scores only.|Slope|-0.023||||0.001|TWO_SIDED|95.0|-0.0362|-0.0093|||Generalized Estimating Equations|GEE analysis conducted on each type of Z score separately with group (CMF, EHF), time (infant age; 0.5-12.5 months) and their interaction.||||-0.0093|-0.0362|0.001
73976924|NCT01700205|147500242|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.02||||0.32|TWO_SIDED|95.0|-0.058|0.019|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction||||0.019|-0.058|0.32
73948076|NCT01755143|147428900|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|95.0||1.9|||exact test of binomial proportions|A priori threshold for statistical significance was 0.05.||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans \>= 10%.||1.9||<0.0001
73948077|NCT01755143|147428901|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|0.2||||0.0004|ONE_SIDED|95.0|-4.8||||Farrington-Manning test|A priori threshold for statistical significance was 0.05.||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-4.8|0.0004
73948078|NCT01555164|147428903|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.11||||0.306|TWO_SIDED|95.0|-0.31|0.1||P-value from a mixed-effect model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.4% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||0.10|-0.31|0.306
73948079|NCT01709305|147428915|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.19|||||TWO_SIDED|98.34|0.02|0.36||||||Pairwise Comparison||0.36|0.02|
73948080|NCT01709305|147428915|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.03|||||TWO_SIDED|98.34|-0.15|0.21||||||Pairwise Comparison||0.21|-0.15|
73948081|NCT01709305|147428915|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|-0.05|||||TWO_SIDED|98.34|-0.23|0.14||||||Pairwise Comparison||0.14|-0.23|
73948082|NCT01709305|147428917|SUPERIORITY_OR_OTHER||Estimate|-8.4|||<|0.001|TWO_SIDED|95.0|-11.1|-6.1|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||-6.1|-11.1|<0.001
73948083|NCT01709305|147428917|SUPERIORITY_OR_OTHER||Estimate|-2.9||||0.072|TWO_SIDED|95.0|-6.1|0.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.3|-6.1|0.072
73948084|NCT01709305|147428917|SUPERIORITY_OR_OTHER||Estimate|-5.3|||<|0.001|TWO_SIDED|95.0|-8.3|-2.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||-2.5|-8.3|<0.001
73948085|NCT01709305|147428918|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.158|TWO_SIDED|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.3|-0.3|0.158
73948086|NCT01709305|147428918|SUPERIORITY_OR_OTHER||Estimate|0.0|||>|0.999|TWO_SIDED|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.7|-0.7|>0.999
73948087|NCT01709305|147428918|SUPERIORITY_OR_OTHER||Estimate|0.2||||0.318|TWO_SIDED|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.0|-0.5|0.318
73948088|NCT01709305|147428919|SUPERIORITY_OR_OTHER||Estimate|0.0||||0.998|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.9|-0.9|0.998
73948089|NCT01709305|147428919|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.319|TWO_SIDED|95.0|-1.0|0.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.5|-1.0|0.319
73948090|NCT01709305|147428919|SUPERIORITY_OR_OTHER||Estimate|0.0||||0.999|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.9|-0.9|0.999
73948091|NCT01709305|147428920|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.651|TWO_SIDED|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.8|-1.3|0.651
73948092|NCT01709305|147428920|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.66|TWO_SIDED|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.8|-1.3|0.660
73948093|NCT01709305|147428920|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.48|TWO_SIDED|95.0|-0.8|1.6|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.6|-0.8|0.480
73948094|NCT01709305|147428921|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.158|TWO_SIDED|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.3|-0.3|0.158
73948095|NCT01709305|147428921|SUPERIORITY_OR_OTHER||Estimate|0.0|||>|0.999|TWO_SIDED|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.7|-0.7|>0.999
73948096|NCT01709305|147428921|SUPERIORITY_OR_OTHER||Estimate|0.2||||0.318|TWO_SIDED|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.0|-0.5|0.318
73948097|NCT02714205|147428959|SUPERIORITY||Model generated Least Square Mean|-0.54||||0.34|TWO_SIDED|95.0|-1.66|0.58|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.58|-1.66|0.34
73948098|NCT02714205|147428960|SUPERIORITY||Model generated Least Square Mean|0.51||||0.88|TWO_SIDED|95.0|-6.15|7.18|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix.|Model generated LS Mean Differences|||7.18|-6.15|0.88
73948099|NCT02714205|147428961|SUPERIORITY||Model generated Least Square Mean|-0.2||||0.57|TWO_SIDED|95.0|-0.88|0.48|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.48|-0.88|0.57
73870465|NCT04737278|147284718|OTHER||||||<|0.01|||||||ANCOVA|||The original report from KGK Synergize/Science did not specify if the results are ANCOVA or a between group comparison at 2ay 28||||<0.01
73870466|NCT04737278|147284719|OTHER|||||||0.31|||||||ANCOVA|||||||0.31
73870467|NCT04737278|147284720|OTHER|||||||0.48|||||||ANCOVA|||||||0.48
73870468|NCT04737278|147284721|OTHER|||||||0.84|||||||ANCOVA|||||||0.84
73870469|NCT04737278|147284722|OTHER|||||||0.63|||||||ANCOVA|||||||0.63
73870470|NCT04737278|147284723|OTHER|||||||0.05|||||||ANCOVA|||||||0.05
73870471|NCT04737278|147284724|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
73870472|NCT04737278|147284725|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
73870473|NCT04737278|147284726|OTHER|||||||0.48|||||||ANCOVA|||||||0.48
73948100|NCT02714205|147428962|SUPERIORITY||Model generated Least Square Mean Differ|-0.09||||0.81|TWO_SIDED|95.0|-0.8|0.63|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.63|-0.8|0.81
73948101|NCT02714205|147428963|SUPERIORITY||Model generated Least Square Mean Differ|0.43||||0.3|TWO_SIDED|95.0|-0.38|1.23|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||1.23|-0.38|0.3
73948102|NCT02714205|147428964|SUPERIORITY||Model generated Least Square Mean Differ|0.4||||0.68|TWO_SIDED|95.0|-1.52|2.32|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||2.32|-1.52|0.68
73948103|NCT02714205|147428965|SUPERIORITY||Model generated Least Square Mean Differ|-0.83||||0.12|TWO_SIDED|95.0|-1.89|0.23|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.23|-1.89|0.12
73948104|NCT02714205|147428966|SUPERIORITY||Model generated Least Square Mean Differ|-1.41||||0.25|TWO_SIDED|95.0|-3.81|0.99|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.99|-3.81|0.25
73948105|NCT01486758|147429005|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANCOVA|||||||0.6
73948106|NCT01486758|147429009|SUPERIORITY_OR_OTHER|||||||0.048|||||||Log Rank|||||||0.048
73948107|NCT02608489|147429014|SUPERIORITY_OR_OTHER|||||||0.221|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.221
73948108|NCT02608489|147429014|SUPERIORITY_OR_OTHER|||||||0.015|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.||||0.015
73948109|NCT02608489|147429015|SUPERIORITY_OR_OTHER|||||||0.256|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.256
73948110|NCT02608489|147429015|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at Postoperative week 12 follow-up.||||0.025
73948111|NCT02608489|147429016|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.080
73948112|NCT02608489|147429016|SUPERIORITY_OR_OTHER|||||||0.021|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.||||0.021
73948113|NCT02608489|147429017|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||<0.001
73948114|NCT02608489|147429017|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4||||<0.001
73948115|NCT02608489|147429017|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12||||<0.001
73948116|NCT02608489|147429018|SUPERIORITY_OR_OTHER|||||||0.045|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.045
73948117|NCT02608489|147429019|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.001
73948118|NCT02608489|147429019|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4||||0.002
73948119|NCT02608489|147429019|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12||||0.034
73948120|NCT02608489|147429020|SUPERIORITY_OR_OTHER|||||||0.151|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.151
73948121|NCT01411501|147429022|SUPERIORITY_OR_OTHER|||||||0.352|TWO_SIDED||||||ANCOVA|||||||0.352
73948122|NCT01411501|147429023|SUPERIORITY_OR_OTHER|||||||0.968|TWO_SIDED||||||ANCOVA|||||||0.968
73948123|NCT01411501|147429024|SUPERIORITY_OR_OTHER|||||||0.841|TWO_SIDED||||||Kruskal-Wallis|||||||0.841
73948124|NCT01411501|147429025|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||||||0.005
73870474|NCT04737278|147284727|OTHER|||||||0.06|||||||ANCOVA|||||||0.06
73948125|NCT01411501|147429026|SUPERIORITY_OR_OTHER|||||||0.198|TWO_SIDED||||||ANCOVA|||||||0.198
73870475|NCT04737278|147284728|OTHER|||||||0.02|||||||ANCOVA|||||||0.02
73948126|NCT01411501|147429027|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Kruskal-Wallis|||||||0.035
73948127|NCT02914184|147429034|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|1.07|||||TWO_SIDED|95.0|0.79|1.44|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_A and Liq\_B groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.44|0.79|
73948128|NCT02914184|147429034|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|0.88|||||TWO_SIDED|95.0|0.65|1.19|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_A and Liq\_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.19|0.65|
73948129|NCT02914184|147429034|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|0.82|||||TWO_SIDED|95.0|0.61|1.11|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_B and Liq\_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.11|0.61|
73948130|NCT02914184|147429035|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in SCR for antibodies to rota virus at month 2-4 between the Liq\_Pool group and Lyo Control group should be ≥ -10%.|SCR difference at Month 2-4|-2.49|||||TWO_SIDED|95.0|-7.15|2.63||||||Non-inferiority of Liq\_Pool group compared to Lyo Control group in terms of difference in % of subjects with anti-RV IgA titer ≥ specified cut off with its 2-sided 95% CI in initially seronegative subjects||2.63|-7.15|
73948131|NCT02914184|147429037|NON_INFERIORITY|LL of the two-sided 95% CI for the ratio of anti-RV IgA antibody GMCs between the Liq\_Pool Group and Control group should be ≥ 0.67.|GMC Ratio at At Month 2-4|1.04|||||TWO_SIDED|95.0|0.82|1.33|||ANOVA|||Non-inferiority of Liq\_Pool Group as compared to Lyo Control group in terms of the GMC ratio calculated using ANOVA model with vaccine groups and country as fixed effects||1.33|0.82|
73948132|NCT00798174|147429044|SUPERIORITY|The null hypothesis was that the azygos coil does not reduce the DFT. (A reduced DFT is superiority).||||||0.103||||||Threshold for significance is 0.05.|t-test, 2 sided|Paired t-test||"The null hypothesis is that there is no difference between the DFT using the azygos coil vs. the standard configuration.~Paired t-test (two-tailed), used due to construction of study with DFT determined in both configurations in each patient, yields p=0.103"||||0.103
73976925|NCT01700205|147500243|OTHER|ANOVA with group (CMF, EHF) as between-subjects factor were conducted on intent-to-treat sample|||||<|0.05|||||||Repeated Measures ANOVA|We conducted a ANOVA with group (CMF, EHF) as between-subject factor.||ANOVAs were conducted with group (CMF, EHF) as the between-subjects factor.||||<0.05
73976926|NCT01700205|147500244|OTHER|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||||||0.72|||||||Repeated Measure ANOVA|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor||||0.72
73976927|NCT01700205|147500245|OTHER|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.72|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||0.72
73976928|NCT01700205|147500246|OTHER|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.02|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||0.02
74032119|NCT02749721|147617313|OTHER||Pearson's R|-0.195||||0.454|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-17 baseline to endpoint percent change||||0.454
73948133|NCT01703702|147429059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.002|TWO_SIDED|95.0|1.22|2.38|||Chi-squared|||||2.38|1.22|0.002
74032120|NCT02749721|147617313|OTHER||Pearson's R|-0.162||||0.579|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-17 baseline to endpoint percent change||||0.579
73870476|NCT04737278|147284729|OTHER|||||||0.03|||||||ANCOVA|||||||0.03
73870477|NCT04737278|147284729|OTHER|||||||0.05|||||||t-test, 2 sided|||comparison of neutrophils from baseline to day 28||||0.05
73870478|NCT04737278|147284730|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
73870479|NCT04737278|147284731|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||comparison of baseline values||||0.47
73870480|NCT04737278|147284731|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||comparison performed on data from day 28||||0.24
73870481|NCT04737278|147284732|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||comparison of eosinophil counts at day 28||||0.11
73870482|NCT04737278|147284733|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||The day 28 basophil counts on day 28 were compared between the two arms of this study.||||0.98
73948134|NCT01703702|147429060|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35||||0.568|TWO_SIDED|95.0|-1.54|0.84|||ANCOVA|Adjusted for: Baseline ADAS-Cog score, study arm, Alzheimer's treatment, country, and interaction between study arm and Alzheimer's treatment.||||0.84|-1.54|0.568
73948135|NCT01703702|147429061|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|43.9|||<|0.001|TWO_SIDED|95.0|20.0|96.12|||Chi-squared|||||96.12|20|<0.001
73948136|NCT01703702|147429062|SUPERIORITY_OR_OTHER||LS Mean Difference|20.69|||<|0.001|TWO_SIDED|95.0|18.95|22.43|||ANCOVA|Adjusted for: Cognitive status (mild impairment/dementia), physician/practice type, country and florbetapir F18 PET scan result (Aß+/Aß-)||Comparison of change in diagnostic confidence at follow-up (3 months)||22.43|18.95|<0.001
73948137|NCT01703702|147429063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.144|TWO_SIDED|95.0|0.92|1.78|||Chi-squared|||||1.78|0.92|0.144
73948138|NCT01703702|147429064|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.925|TWO_SIDED|95.0|-3.2|3.53|||ANCOVA|Adjusted for: Baseline scale, Cognitive status (mild impairment/dementia), country and florbetapir F18 PET scan result (Aß+/Aß-).||||3.53|-3.20|0.925
73948139|NCT01703702|147429065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.857|TWO_SIDED|95.0|0.7|1.54|||Chi-squared|||Major Diagnostic Tests||1.54|0.70|0.857
73948140|NCT01703702|147429065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.36|2.81|||Chi-squared|||Alzheimer's/Cognitive Medication||2.81|1.36|<0.001
73948141|NCT01703702|147429065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.063|TWO_SIDED|95.0|0.97|2.64|||Chi-squared|||Neuropsychological Tests||2.64|0.97|0.063
73948142|NCT01703702|147429065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.741|TWO_SIDED|95.0|0.69|1.7|||Chi-squared|||Physician Follow-up for Re-evaluation||1.70|0.69|0.741
73948143|NCT01703702|147429065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.046|TWO_SIDED|95.0|1.01|2.08|||Chi-squared|||Specialist Referral||2.08|1.01|0.046
74089274|NCT02697773|147731611|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0014|TWO_SIDED|95.0|1.31|3.04|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.31|0.0014
74089275|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.3|2.78|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.78|1.30|0.0009
73948144|NCT03980184|147429074|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
73976929|NCT01728324|147500248|SUPERIORITY_OR_OTHER||Adjusted response rate|81.1|||<|0.0001|TWO_SIDED|95.0|76.34|85.87|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.|The adjusted response rate was tested against the historical control SVR rate of 68% (95% Confidence Interval (CI): 76.3, 85.9).|The proportion of patients achieving SVR12 achieved with 24 weeks of treatment with DBV/FDV/RBV in cirrhotic and non-cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.||85.87|76.34|<0.0001
74089276|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0004|TWO_SIDED|95.0|1.36|2.9|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.90|1.36|0.0004
74089277|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0015|TWO_SIDED|95.0|1.29|2.96|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.29|0.0015
73948145|NCT03980184|147429075|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<.001
74009127|NCT03492554|147568950|OTHER||||||<|0.0001|||||||1 sided exact binomial test|||H0: Sensitivity = 90% H1: Sensitivity \> 90% Under the assumption that the true population sensitivity is 95%, 231 subjects who were diagnosed with AF based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject the null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms, a minimum of 260 subjects with a known diagnosis of AF were enrolled.||||<0.0001
74089278|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0008|TWO_SIDED|95.0|1.34|3.07|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.07|1.34|0.0008
74089279|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0251|TWO_SIDED|95.0|1.07|2.75|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.75|1.07|0.0251
74089280|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0276|TWO_SIDED|95.0|1.06|2.72|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|1.06|0.0276
73948146|NCT03980184|147429076|SUPERIORITY|||||||0.703|||||||Fisher Exact|||||||0.703
73948147|NCT03980184|147429078|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
73948148|NCT03980184|147429079|SUPERIORITY|||||||0.647|||||||Fisher Exact|||||||0.647
73948149|NCT03980184|147429080|SUPERIORITY|||||||0.887|||||||Fisher Exact|||||||0.887
73948150|NCT02002884|147429088|SUPERIORITY||LS Mean difference|-0.22|||=|0.017|TWO_SIDED|95.0|-0.4|-0.04|||MMRM|||LS-Means are from mixed model with treatment group, pooled site and pre-treatment status included as fixed factors and AS at baseline, Gross Motor Function Classification System-Extended and Revised (GMFCS-E\&R) level at screening included as covariates. For MMRM visit\*treatment is interaction term repeated factor.||-0.04|-0.4|= 0.017
73948151|NCT02002884|147429088|SUPERIORITY||LS-Mean difference|-0.07|||=|0.546|TWO_SIDED|95.0|-0.29|0.15|||MMRM|||LS-Means are from mixed model with treatment group, pooled site and pre-treatment status included as fixed factors and AS at baseline, GMFCS-E\&R level at screening included as covariates. For MMRM visit\*treatment is interaction term repeated factor.||0.15|-0.29|= 0.546
73948152|NCT02002884|147429089|SUPERIORITY||LS-Mean difference|0.09|||=|0.34|TWO_SIDED|95.0|-0.1|0.28|||ANCOVA|||LS-Means are from analysis of covariance (ANCOVA) with treatment group, pooled site and pretreatment status included as fixed factors and maximum AS score of the two possible primary target patterns flexed elbow or flexed wrist baseline, GMFCS-E\&R level at screening included as covariates.||0.28|-0.1|= 0.34
73948153|NCT02002884|147429089|SUPERIORITY||LS-Mean difference|-0.12|||=|0.297|TWO_SIDED|95.0|-0.36|0.11|||ANCOVA|||LS-Means are from ANCOVA with treatment group, pooled site and pre-treatment status included as fixed factors and maximum AS score of the two possible primary target patterns flexed elbow or flexed wrist baseline, GMFCS-E\&R level at screening included as covariates.||0.11|-0.36|= 0.297
73948154|NCT02966002|147429103|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
73948155|NCT02966002|147429104|OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.67
73976930|NCT01728324|147500248|SUPERIORITY_OR_OTHER||Adjusted response rate|75.89||||0.002|TWO_SIDED|95.0|70.63|81.14|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.||The proportion of patients achieving SVR12 achieved with 16 weeks of treatment of non-cirrhotic and 24 weeks of treatment of cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.||81.14|70.63|0.0020
73976931|NCT01728324|147500249|SUPERIORITY_OR_OTHER||SVR12 Rates difference|6.4||||0.0532|TWO_SIDED|95.0|-1.4|14.2|||Koch's method|Adjusted for PegIFN eligibility using Koch's method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||14.2|-1.4|0.0532
73976932|NCT01728324|147500250|SUPERIORITY_OR_OTHER||SVR4 Rates difference|3.6||||0.1671|TWO_SIDED|95.0|-3.7|10.9|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||10.9|-3.7|0.1671
73976933|NCT01728324|147500251|SUPERIORITY_OR_OTHER||SVR24 Rates difference|-6.9||||0.0447|TWO_SIDED|95.0|-14.8|1.1|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||1.1|-14.8|0.0447
73976934|NCT03335488|147500271|SUPERIORITY||Odds Ratio (OR)|1.1||||1|TWO_SIDED|95.0|0.0|28.1|||Fisher Exact|||||28.1|0.0|1.0000
73976935|NCT03335488|147500273|SUPERIORITY|||||||0.8464|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 1||||0.8464
73976936|NCT03335488|147500273|SUPERIORITY|||||||0.104|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 2||||0.1040
73976937|NCT03335488|147500273|SUPERIORITY|||||||0.0979|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 3||||0.0979
73976938|NCT03335488|147500273|SUPERIORITY|||||||0.9808|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 0 Hr||||0.9808
73976939|NCT03335488|147500273|SUPERIORITY|||||||0.8329|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 4 Hr||||0.8329
73976940|NCT03335488|147500273|SUPERIORITY|||||||0.2544|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 8 Hr||||0.2544
73976941|NCT03335488|147500274|SUPERIORITY|||||||0.8579||||||P-value is from a t-test comparing log-transformed RAVICTI vs NaPBA values.|t-test|||||||0.8579
73976942|NCT03335488|147500275|SUPERIORITY|||||||0.7155||||||P-value is from a t-test comparing log-transformed RAVICTI vs NaPBA values.|t-test|||||||0.7155
73976943|NCT00087022|147500294|SUPERIORITY|||||||0.737|||||||Log Rank|||||||0.737
73976944|NCT00087022|147500295|SUPERIORITY|||||||1.012|||||||Log Rank|||||||1.012
74032121|NCT02749721|147617313|OTHER||Pearson's R|0.232||||0.549|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-17 baseline to endpoint percent change||||0.549
74032122|NCT02749721|147617313|OTHER||Pearson's R|0.169||||0.518|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and HDRS-17 baseline to endpoint percent change||||0.518
73976945|NCT00087022|147500298|SUPERIORITY|||||||0.022|||||||Log Rank|||||||0.022
73976946|NCT03758742|147500327|SUPERIORITY||||||<|0.0001|||||||Binomial Test|||||||<0.0001
73976947|NCT02823028|147500481|SUPERIORITY||Odds Ratio (OR)|0.931||||0.779|TWO_SIDED||||||Chi-squared|||||||.779
73976948|NCT02409680|147500482|SUPERIORITY||Risk Ratio (RR)|0.89||||0.012|TWO_SIDED|95.0|0.81|0.98||A-priori threshold for statistical significance at 0.05 was specified.|Cochran-Mantel-Haenszel|||The null hypothesis is there is no treatment effect on preterm delivery.||0.98|0.81|0.012
74032123|NCT02749721|147617313|OTHER||Pearson's R|0.027||||0.922|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and HDRS-17 baseline to endpoint percent change||||0.922
74032124|NCT02749721|147617313|OTHER||Pearson's R|-0.064||||0.796|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and QIDS-SR baseline scores||||0.796
73976949|NCT02409680|147500483|SUPERIORITY||Risk Ratio (RR)|1.08||||0.299|TWO_SIDED|95.0|0.94|1.25|||Cochran-Mantel-Haenszel|||||1.25|0.94|0.299
73976950|NCT02409680|147500484|SUPERIORITY||Risk Ratio (RR)|0.95||||0.171|TWO_SIDED|95.0|0.9|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.90|0.171
73976951|NCT02409680|147500485|SUPERIORITY||Risk Ratio (RR)|0.86||||0.048|TWO_SIDED|95.0|0.73|1.0|||Cochran-Mantel-Haenszel|||||1.00|0.73|0.048
73976952|NCT02409680|147500486|SUPERIORITY||Risk Ratio (RR)|0.87||||0.125|TWO_SIDED|95.0|0.73|1.04|||Cochran-Mantel-Haenszel|||||1.04|0.73|0.125
73976953|NCT02409680|147500487|SUPERIORITY||Risk Ratio (RR)|1.03||||0.9|TWO_SIDED|95.0|0.6|1.79|||Cochran-Mantel-Haenszel|||||1.79|0.60|0.900
73976954|NCT02409680|147500488|SUPERIORITY||Risk Ratio (RR)|1.25||||0.274|TWO_SIDED|95.0|0.84|1.86|||Cochran-Mantel-Haenszel|||||1.86|0.84|0.274
73976955|NCT02409680|147500489|SUPERIORITY||Risk Ratio (RR)|0.75||||0.512|TWO_SIDED|95.0|0.32|1.78|||Cochran-Mantel-Haenszel|||||1.78|0.32|0.512
73976956|NCT02409680|147500490|SUPERIORITY||Risk Ratio (RR)|0.77||||0.331|TWO_SIDED|95.0|0.45|1.31|||Cochran-Mantel-Haenszel|||||1.31|0.45|0.331
73976957|NCT02409680|147500492|SUPERIORITY||Risk Ratio (RR)|0.38||||0.015|TWO_SIDED|95.0|0.17|0.85|||Cochran-Mantel-Haenszel|||||0.85|0.17|0.015
73976958|NCT02409680|147500493|SUPERIORITY||Risk Ratio (RR)|0.75||||0.039|TWO_SIDED|95.0|0.61|0.93|||Cochran-Mantel-Haenszel|||||0.93|0.61|0.039
73976959|NCT02409680|147500494|SUPERIORITY||Risk Ratio (RR)|0.93||||0.073|TWO_SIDED|95.0|0.87|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.87|0.073
73976960|NCT02409680|147500495|SUPERIORITY||Risk Ratio (RR)|0.87||||0.084|TWO_SIDED|95.0|0.57|1.33|||Cochran-Mantel-Haenszel|||||1.33|0.57|0.084
73976961|NCT02409680|147500496|SUPERIORITY||Risk Ratio (RR)|0.86||||0.039|TWO_SIDED|95.0|0.73|1.0|||Cochran-Mantel-Haenszel|||||1.00|0.73|0.039
74032125|NCT02749721|147617313|OTHER||Pearson's R|-0.506||||0.054|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and QIDS-SR baseline scores||||0.054
74032126|NCT02749721|147617313|OTHER||Pearson's R|0.002||||0.995|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and QIDS-SR baseline scores||||0.995
73870483|NCT04737278|147284734|OTHER|||||||0.025||||||This p value is for the treatment source. Visits (p=0.422) and visits x treatments (p=0.153) did not meet the threshold of significance.|ANOVA|||"All other statistical analyses were performed by KGK Synergize. This site was used to determine that the NLR were normally distributed https://www.gigacalculator.com/calculators/normality-test-calculator.php~Because these data fulfilled the assumptions of ANOVA, the data were analyzed using this site:~http://vassarstats.net/anova2u.html"||||0.025
73948156|NCT02966002|147429105|OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
74032127|NCT02749721|147617313|OTHER||Pearson's R|0.102||||0.668|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and QIDS-SR baseline scores||||0.668
73870484|NCT04737278|147284735|OTHER|||||||0.06|||||||t-test, 2 sided|||Comparison of blood glucose in the Cunermuspir arm between enrollment baseline and day 28.||||0.06
73870485|NCT04737278|147284735|OTHER|||||||0.04|||||||t-test, 2 sided|||Comparison of enrollment baseline blood glucose and day 28 in the placebo arm||||0.04
73870486|NCT04737278|147284735|OTHER|||||||0.92|||||||ANCOVA|||||||0.92
73948157|NCT02966002|147429106|OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
73948158|NCT03377790|147429109|SUPERIORITY||||||<|0.0001||||||Differences between treatments arms are compared using a chi-square test.|Chi-squared|||||||<0.0001
73948159|NCT03377790|147429110|SUPERIORITY|||||||0.0067|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0067
73948160|NCT03377790|147429111|SUPERIORITY|||||||0.0152|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0152
73948161|NCT03377790|147429112|SUPERIORITY|||||||0.0302|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0302
73948162|NCT03377790|147429113|SUPERIORITY|||||||0.5921|||||||ANCOVA|Differences between Tx arms are compared using an ANCOVA with treatment as the independent factor and baseline CDLQI composite score as the covariate.||||||0.5921
73948163|NCT03377790|147429114|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.||||||<0.0001
73948164|NCT03377790|147429115|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.||||||<0.0001
73948165|NCT03377790|147429116|SUPERIORITY||||||<|0.0001|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||<0.0001
73948166|NCT03377790|147429117|SUPERIORITY||||||<|0.0001|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||<0.0001
73948167|NCT03377790|147429118|SUPERIORITY|||||||0.052|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0520
73948168|NCT03469349|147429140|SUPERIORITY||Least square mean difference|29.19|STANDARD_ERROR_OF_MEAN|10.083||0.0041|TWO_SIDED|95.0|9.35|49.02|||MMRM|||Least squares means, p-values were obtained using a mixed model for repeated measures (MMRM) analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||49.02|9.35|0.0041
73948169|NCT03469349|147429141|SUPERIORITY||Least square mean difference|15.86|STANDARD_ERROR_OF_MEAN|7.814||0.0431|TWO_SIDED|95.0|0.49|31.24|||MMRM|||Week 2: Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||31.24|0.49|0.0431
73948170|NCT03469349|147429141|SUPERIORITY||Least square mean difference|35.51|STANDARD_ERROR_OF_MEAN|12.48||0.0047|TWO_SIDED|95.0|10.96|60.05|||MMRM|||Week 24: Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||60.05|10.96|0.0047
73948171|NCT03469349|147429142|SUPERIORITY|||||||0.0227|||||||MMRM|||Week 2: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0227
73948172|NCT03469349|147429142|SUPERIORITY|||||||0.0007|||||||MMRM|||Week 12: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0007
73948173|NCT03469349|147429142|SUPERIORITY|||||||0.0023|||||||MMRM|||Week 24: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0023
73948174|NCT03469349|147429143|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.9592||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||Week 12||||0.9592
73948175|NCT03469349|147429143|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.5823||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||Week 24||||0.5823
73948176|NCT03469349|147429144|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.9424||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||||||0.9424
73948177|NCT03469349|147429145|SUPERIORITY|||||||0.3758|||||||MMRM|||Physical Health Score: Week 12; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.3758
73948178|NCT03469349|147429145|SUPERIORITY|||||||0.1412|||||||MMRM|||Physical Health Score: Week 24; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.1412
74032128|NCT02749721|147617313|OTHER||Pearson's R|0.037||||0.875|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and QIDS-SR baseline scores||||0.875
73948179|NCT03469349|147429145|SUPERIORITY|||||||0.1009|||||||MMRM|||Mental Health Score: Week 12; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.1009
73948180|NCT03469349|147429145|SUPERIORITY|||||||0.0015|||||||MMRM|||Mental Health Score: Week 24; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0015
73948181|NCT01381874|147429148|SUPERIORITY||Hazard Ratio (HR)|1.143||||0.437|TWO_SIDED|95.0|0.816|1.603|||stratified log-rank test|||||1.603|0.816|0.437
73948182|NCT01381874|147429148|SUPERIORITY||Hazard Ratio (HR)|0.958||||0.794|TWO_SIDED|95.0|0.695|1.32|||stratified log-rank test|||||1.320|0.695|0.794
73948183|NCT01381874|147429149|SUPERIORITY||Hazard Ratio (HR)|1.074||||0.807|TWO_SIDED|95.0|0.608|1.896|||stratified log-rank test|||||1.896|0.608|0.807
73948184|NCT01381874|147429149|SUPERIORITY||Hazard Ratio (HR)|1.183||||0.542|TWO_SIDED|95.0|0.688|2.036|||stratified log-rank test|||||2.036|0.688|0.542
73948185|NCT01381874|147429150|SUPERIORITY||Risk Ratio (RR)|0.909||||1|TWO_SIDED|95.0|0.213|3.878|||Fisher Exact|||||3.878|0.213|1.000
73948186|NCT01381874|147429150|SUPERIORITY||Risk Ratio (RR)|1.909||||0.366|TWO_SIDED|95.0|0.605|6.026|||Fisher Exact|||||6.026|0.605|0.366
73948187|NCT01381874|147429151|SUPERIORITY||Risk Ratio (RR)|0.757||||0.603|TWO_SIDED|95.0|0.264|2.175|||Chi-squared|||||2.175|0.264|0.603
73948188|NCT01381874|147429151|SUPERIORITY||Risk Ratio (RR)|1.79||||0.137|TWO_SIDED|95.0|0.816|3.926|||Chi-squared|||||3.926|0.816|0.137
73976962|NCT02409680|147500497|SUPERIORITY||Risk Ratio (RR)|0.88||||0.261|TWO_SIDED|95.0|0.7|1.1|||Cochran-Mantel-Haenszel|||||1.10|0.70|0.261
74032129|NCT02749721|147617313|OTHER||Pearson's R|-0.049||||0.852|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and QIDS-SR baseline to endpoint percent change||||0.852
73948189|NCT01027364|147429237|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.17|||<|0.001|TWO_SIDED|95.0|0.11|0.24||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have \> 95% power at the 2-sided 0.05 level of significance, based upon this hypothesis test.||0.24|0.11|<0.001
73948190|NCT01027364|147429237|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.2||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations.||0.20|0.08|<0.001
73948191|NCT00985543|147429242|NON_INFERIORITY_OR_EQUIVALENCE|Results are considered statistically significant at p\<0.05 or when 90% confidence intervals do not cross the value 1. No adjustments are made for multiple comparisons.|||||<|0.05|TWO_SIDED|90.0|||||maximum likelihood regression|||Dosing regimens lopinavir/ritonavir 200/150mg BID (Phase 2) and lopinavir/ritonavir 200/50mg BID (Phase 3) will be considered equivalent to lopinavir/ritonavir 400/100mg BID (Phase 1) if the 90% confidence interval (CI) for the mean AUC0-12h ratio and maximum concentration (Cmax) ratio lie between 0.80 and 1.25.||||<0.05
73948192|NCT00114634|147429257|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
73948193|NCT03662997|147429309|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.046||||||Five-layer vs Hydrocellular arm, Weeks 1 \& 3|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.046
73948194|NCT03662997|147429309|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.56||||||Five-layer vs Hydrocellular arm; Weeks 2 \& 4|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.56
73948195|NCT03662997|147429309|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.01||||||Five-layer vs Hydropolymer arm; Weeks 1 \& 3|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.010
73948196|NCT03662997|147429309|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.25||||||Five-layer vs Hydropolymer arm; Weeks 2 \& 4|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.25
73976963|NCT02409680|147500498|SUPERIORITY||Risk Ratio (RR)|0.85||||0.141|TWO_SIDED|95.0|0.68|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.68|0.141
73976964|NCT02409680|147500499|SUPERIORITY||Risk Ratio (RR)|1.4||||0.157|TWO_SIDED|95.0|0.88|2.23|||Cochran-Mantel-Haenszel|||||2.23|0.88|0.157
73976965|NCT02294461|147500550|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Cox Proportional Hazards|0.38|||<|0.0001|TWO_SIDED|95.0|0.27|0.52|||Hazard Ratio|||P-value is based on an unstratified log-rank test. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.52|0.27|<0.0001
73976966|NCT02294461|147500551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.0208|TWO_SIDED|95.0|0.51|0.95||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had died at the analysis date were censored at date last known alive. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.95|0.51|0.0208
73948197|NCT03662997|147429310|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.046||||||Five-layer vs Hydrocellular; End of Weeks 1 and 3.|Chi-squared, Corrected||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.046
73948198|NCT03662997|147429310|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.01||||||Five-layer vs Hydropolymer; End of Weeks 1 \& 3|Chi-squared, Corrected||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups|||0.010
73948199|NCT03662997|147429318|SUPERIORITY|This secondary outcome measure was not planned for at the initiation of the study. Compliance rates were calculated by combining the number incidences that dressings were worn for the full 7 days and when the dressings do not have strike-through during first the week of treatment.|||||<|0.05||||||Five-layer vs Hydrocellular arm, first week of treatment|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||<0.05
73948200|NCT03662997|147429318|SUPERIORITY|This secondary outcome measure was not planned for at the initiation of the study. Compliance rates were calculated by combining the number incidences that dressings were worn for the full 7 days and when the dressings do not have strike-through during the first week of treatment.|||||<|0.05||||||Five-layer vs Hydropolymer, first week of treatment.|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||<0.05
73976967|NCT02294461|147500552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001||95.0|0.2|0.46||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had an rPFS event were censored at the date of the last assessment showing no objective evidence of rPFS prior to scan modality change, new antineoplastic treatment, initiation of radiation therapy for prostate cancer, skeletal-related event (SRE) and 2 or more consecutive missed tumor assessments. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide.||0.46|0.20|<0.0001
73976968|NCT02294461|147500553|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.2501|TWO_SIDED|95.0|0.21|1.52||P-value was based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not have an SRE were censored at the date of the last assessment indicating no evidence of SRE. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||1.52|0.21|0.2501
73976969|NCT02294461|147500554|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28||||0.002||95.0|0.12|0.66||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not start cytotoxic chemotherapy were censored at the date of the last assessment indicating no evidence of cytotoxic chemotherapy usage. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.66|0.12|0.0020
73976970|NCT02294461|147500555|SUPERIORITY_OR_OTHER_LEGACY||Difference of response rate|55.8|||<|0.0001|TWO_SIDED|95.0|47.4|64.2||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel %|||||64.2|47.4|<0.0001
74032130|NCT02749721|147617313|OTHER||Pearson's R|-0.34||||0.234|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and QIDS-SR baseline to endpoint percent change||||0.234
73976971|NCT02294461|147500556|SUPERIORITY_OR_OTHER_LEGACY||Difference in objective response rate|26.0|||<|0.0001|TWO_SIDED|95.0|14.7|37.4||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel|||When deriving the response category, it was based on the target, non-target and new lesions without confirming CR, PR, and Progressive disease (PD). Participants with no post baseline assessment were included in the category of Nonevaluable (NE). The best overall soft tissue objective response was defined as PR or CR based on the investigator assessments of target, non-target and new lesions while on the study treatment.||37.4|14.7|<0.0001
73976972|NCT04172675|147500568|SUPERIORITY||Hazard Ratio (HR)|0.28|||=|0.0007|TWO_SIDED|95.0|0.13|0.61|||Unstratified Log rank||Hazard ratio and 95% CI were estimated using a Cox proportional hazards regression model.|||0.61|0.13|=0.0007
74032131|NCT02749721|147617313|OTHER||Pearson's R|0.655||||0.056|TWO_SIDED||||||Pearson's correlation|||||||0.056
74032132|NCT02749721|147617313|OTHER||Pearson's R|0.297||||0.248|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and QIDS-SR baseline to endpoint percent change||||0.248
74032133|NCT02749721|147617313|OTHER||Pearson's R|0.179||||0.507|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and QIDS-SR baseline to endpoint percent change||||0.507
74032134|NCT02749721|147617313|OTHER||Pearson's R|0.049||||0.841|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and PDQ baseline scores||||0.841
73976973|NCT05349721|147500574|OTHER||Treatment Difference|6.86||||0.516|TWO_SIDED|95.0|-13.86|27.59|||ANCOVA|Estimates were derived from the ANCOVA model (following multiple imputation), where participant ranks served as the response variable.||||27.59|-13.86|0.516
73976974|NCT03070392|147500588|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.71|||Log Rank|||||0.71|0.37|<0.0001
73976975|NCT03070392|147500590|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0139|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||||0.94|0.58|0.0139
74032135|NCT02749721|147617313|OTHER||Pearson's R|-0.185||||0.508|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and PDQ baseline scores||||0.508
74032136|NCT02749721|147617313|OTHER||Pearson's R|-0.03||||0.916|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and PDQ baseline scores||||0.916
74032137|NCT02749721|147617313|OTHER||Pearson's R|-0.345||||0.147|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and PDQ baseline scores||||0.147
74032138|NCT02749721|147617313|OTHER||Pearson's R|-0.284||||0.225|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and PDQ baseline scores||||0.225
73870487|NCT04737278|147284736|OTHER|||||||0.51|||||||ANCOVA|||||||0.51
73948201|NCT00007475|147429319|SUPERIORITY_OR_OTHER||Proportion with reduced proteinuria|0.6363|STANDARD_ERROR_OF_MEAN|0.0698|<|0.0001|TWO_SIDED|95.0|0.3079|0.8907||Exact binomial test of proportion of participants exhibiting reduction in proteinuria (see definition below), under null hypothesis that the overall proportion is zero.|Exact binomial test|Tested under null hypothesis that the overall proportion is zero.|Proportion event definition: exhibiting reduction in proteinuria post-cyclophosphamide (complete- \[urine protein {UP} \<0.3\] or or partial-remission \[between 0.3 \& 2.0, inclusive\], limited response \[UP between 2.0 \& 3.5\] yet no relapse \[UP 3.5+\]).|No groups compared, yet null hypothesis: pooled proportion = 0, tested using counts pooled across baseline FPF assay-availability groups (7 across 3 arms) excluding 4 non-completers (yielding 7/11 with event below). Given the modest group-specific sample sizes and tendency for zero outcomes to be observed in a group, we employ exact binomial 95% confidence intervals using the method of Clopper and Pearson (1934; calculated along with corresponding tests using Michael Fay's exactci package in R).||0.8907|0.3079|<0.0001
73948202|NCT01121484|147429348|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||Null hypothesis: no difference between treatment groups||||0.004
73948203|NCT01121484|147429349|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CGI-I analyzed as a categorical variable by Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores, controlling for the effect of region; p-value obtained from the alternative hypothesis of Row Mean Score Differences.|Cochran-Mantel-Haenszel|||||||<0.001
73948204|NCT01121484|147429350|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.002
73948205|NCT01121484|147429351|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.002
73948206|NCT01121484|147429352|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.158
73948207|NCT01121484|147429353|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||<0.001
74032139|NCT02749721|147617313|OTHER||Pearson's R|-0.044||||0.868|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and PDQ baseline to endpoint percent change||||0.868
73870488|NCT04737278|147284737|OTHER|||||||0.38|||||||ANCOVA|||||||0.38
73870489|NCT04737278|147284738|OTHER|||||||0.01|||||||ANCOVA|||||||0.01
73870490|NCT04737278|147284739|OTHER|||||||0.23|||||||ANCOVA|||||||0.23
73870491|NCT04737278|147284739|OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
73870492|NCT04737278|147284739|OTHER|||||||0.01|||||||t-test, 2 sided|||Blood sodium concentration between baseline and day 28 in the Placebo group.||||0.01
73870493|NCT04737278|147284740|OTHER|||||||0.58|||||||ANCOVA|||||||0.58
73870494|NCT04737278|147284740|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison of blood potassium concentration upon enrollment and day 28 in the Cunermuspir participants||||<0.001
73948208|NCT00936221|147429396|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.3873|TWO_SIDED|80.0|0.67|1.28||1-sided p-value|Regression, Cox|Cox model adjusting for treatment, WHO performance status, LDH, M status and tumour sub-type.||If the true hazard ratio (HR) is 0.57, 58 deaths provides at least 80% power to demonstrate a statistically significant difference for OS, assuming a 1-sided 10% significance level.||1.28|0.67|0.3873
73948209|NCT03820323|147429400|SUPERIORITY||Risk Ratio (RR)|0.99||||0.55|TWO_SIDED|95.0|0.94|1.03|||Modified Poisson regression|||||1.03|0.94|0.55
73948210|NCT03820323|147429401|SUPERIORITY||Risk Ratio (RR)|0.86||||0.28|TWO_SIDED|95.0|0.66|1.13|||Modified Poission regression|||||1.13|0.66|0.28
73976976|NCT03861052|147500601|SUPERIORITY||Least Squares Mean Difference|-1.09|||<|0.001|TWO_SIDED|95.0|-1.27|-0.9|||Mixed Models Analysis|||||-0.90|-1.27|<0.001
73976977|NCT03861052|147500601|SUPERIORITY||Least Squares Mean Difference|-1.27|||<|0.001|TWO_SIDED|95.0|-1.45|-1.08|||Mixed Models Analysis|||||-1.08|-1.45|<0.001
73976978|NCT03861052|147500601|SUPERIORITY||Least Squares Mean Difference|-1.53|||<|0.001|TWO_SIDED|95.0|-1.71|-1.35|||Mixed Models Analysis|||||-1.35|-1.71|<0.001
73976979|NCT03861052|147500602|SUPERIORITY||Odds Ratio (OR)|9.89|||<|0.001|TWO_SIDED|95.0|4.53|21.55|||Regression, Logistic|||||21.55|4.53|<0.001
73976980|NCT03861052|147500602|SUPERIORITY||Odds Ratio (OR)|20.57|||<|0.001|TWO_SIDED|95.0|7.73|54.71|||Regression, Logistic|||||54.71|7.73|<0.001
73976981|NCT03861052|147500602|SUPERIORITY||Odds Ratio (OR)|85.31|||<|0.001|TWO_SIDED|95.0|15.8|460.58|||Regression, Logistic|||||460.58|15.80|<0.001
73976982|NCT03861052|147500603|SUPERIORITY||Least Squares Mean Difference|-25.9|||<|0.001|TWO_SIDED|95.0|-30.7|-21.1|||Mixed Models Analysis|||||-21.1|-30.7|<0.001
73976983|NCT03861052|147500603|SUPERIORITY||Least Squares Mean Difference|-32.7|||<|0.001|TWO_SIDED|95.0|-37.5|-27.8|||Mixed Models Analysis|||||-27.8|-37.5|<0.001
73976984|NCT03861052|147500603|SUPERIORITY||Least Squares Mean Difference|-35.7|||<|0.001|TWO_SIDED|95.0|-40.6|30.9|||Mixed Models Analysis|||||30.9|-40.6|<0.001
73976985|NCT03861052|147500604|SUPERIORITY||Least Squares Mean Difference|-17.3|||<|0.001|TWO_SIDED|95.0|-21.4|-13.2|||ANCOVA|||||-13.2|-21.4|<0.001
73976986|NCT03861052|147500604|SUPERIORITY||Least Squares Mean Difference|-22.0|||<|0.001|TWO_SIDED|95.0|-26.1|-17.9|||ANCOVA|||||-17.9|-26.1|<0.001
73976987|NCT03861052|147500604|SUPERIORITY||Least Squares Mean Difference|-26.4|||<|0.001|TWO_SIDED|95.0|-30.5|-22.2|||ANCOVA|||||-22.2|-30.5|<0.001
73976988|NCT03861052|147500605|SUPERIORITY||Least Squares Mean Difference|-5.2|||<|0.001|TWO_SIDED|95.0|-6.4|-4.1|||Mixed Models Analysis|||||-4.1|-6.4|<0.001
73976989|NCT03861052|147500605|SUPERIORITY||Least Squares Mean Difference|-7.9|||<|0.001|TWO_SIDED|95.0|-9.1|-6.8|||Mixed Models Analysis|||||-6.8|-9.1|<0.001
73870495|NCT04737278|147284740|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison of blood potassium concentrations from enrollment to day 28 in participants in the Placebo arm.||||<0.001
73870496|NCT04737278|147284741|OTHER|||||||0.87|||||||ANCOVA|||||||0.87
73948211|NCT00879996|147429425|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9134||||0.77|TWO_SIDED|95.0|0.4156|2.007|||Log Rank|||Null hypothesis: Methadone and buprenorphine treatment do not differ in treatment retention.||2.007|0.4156|0.77
73948212|NCT00879996|147429426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.043||95.0|||||ANOVA|||Null hypothesis: Methadone treatment is as effective as buprenorphine treatment in reducing pain.||||<0.043
73948213|NCT00879996|147429427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.0|<|0.665|TWO_SIDED|95.0|||||ANOVA|||null-hypothesis: methadone and buprenorphine treatment are equally effective in reducing self-reported functioning at 6 months.||||<0.665
73948214|NCT00879996|147429428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|STANDARD_DEVIATION|0.0|<|0.039|TWO_SIDED|95.0|||||Fisher Exact|||Null hypothesis: methadone or buprenorphine treatment equally reduce illicit drug use.||||<0.039
73948215|NCT02912468|147429433|SUPERIORITY||LS mean difference|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.71|||ANCOVA|||Data were analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.71|-1.07|<0.0001
73976990|NCT03861052|147500605|SUPERIORITY||Least Squares Mean Difference|-10.1|||<|0.001|TWO_SIDED|95.0|-11.3|-9.0|||Mixed Models Analysis|||||-9.0|-11.3|<0.001
73976991|NCT03861052|147500606|SUPERIORITY||Odds Ratio (OR)|14.44|||<|0.001|TWO_SIDED|95.0|7.88|26.46|||Regression, Logistic|||||26.46|7.88|<0.001
73976992|NCT03861052|147500606|SUPERIORITY||Odds Ratio (OR)|44.96|||<|0.001|TWO_SIDED|95.0|23.12|87.45|||Regression, Logistic|||||87.45|23.12|<0.001
73976993|NCT03861052|147500606|SUPERIORITY||Odds Ratio (OR)|82.67|||<|0.001|TWO_SIDED|95.0|39.84|171.52|||Regression, Logistic|||||171.52|39.84|<0.001
73976994|NCT03861052|147500607|SUPERIORITY||Least Squares Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.67|-1.28|||Mixed Models Analysis|||||-1.28|-3.67|<0.001
74089281|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0404|TWO_SIDED|95.0|1.03|3.71|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.71|1.03|0.0404
73870497|NCT04737278|147284741|OTHER|||||||0.003|||||||t-test, 2 sided|||comparison between baseline and day 28 chloride concentrations in the Cunermuspir group||||0.003
73870498|NCT04737278|147284741|OTHER|||||||0.003|||||||t-test, 2 sided|||comparison of blood chloride concentrations between baseline and day 28 in Placebo Arm participants||||0.003
73870499|NCT04737278|147284742|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Bilirubin concentrations between Placebo and Cunermuspir compared at day 28||||0.36
73870500|NCT04737278|147284742|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed-Rank||comparison of bilirubin concentrations between baseline and day 28 in the Cunermuspir Arm||||0.72
73870501|NCT04737278|147284742|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||bilirubin concentrations compared between baseline and Day 28 in the Placebo Arm||||0.35
73870502|NCT04737278|147284743|OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
73870503|NCT04737278|147284743|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||comparison between baseline and day 28 values in Cunermuspir group||||0.4
73870504|NCT04737278|147284743|OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||comparison between baseline and day 28 values for the Placebo Arm||||0.8
73870505|NCT04737278|147284744|OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||comparison of AST enzyme activity in blood on day 28 between Cunermuspir and Placebo||||0.62
73870506|NCT04737278|147284744|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||baseline to day 28 comparison||||0.24
73870507|NCT04737278|147284744|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||baseline to day 28 comparison of AST activity in Placebo group||||0.11
73948216|NCT02912468|147429434|SUPERIORITY||LS mean difference|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.43|-1.69|||ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.69|-2.43|<0.0001
73976995|NCT03861052|147500607|SUPERIORITY||Least Squares Mean Difference|-3.27|STANDARD_ERROR_OF_MEAN|0.592|<|0.001|TWO_SIDED|95.0|-4.43|-2.11|||Mixed Models Analysis|||||-2.11|-4.43|<0.001
73976996|NCT03861052|147500607|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.587|<|0.001|TWO_SIDED|95.0|-4.55|-2.25|||Mixed Models Analysis|||||-2.25|-4.55|<0.001
73976997|NCT03861052|147500608|SUPERIORITY||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||Mixed Models Analysis|||||-0.13|-0.40|<0.001
73976998|NCT03861052|147500608|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|95.0|-0.53|-0.27|||Mixed Models Analysis|||||-0.27|-0.53|<0.001
73976999|NCT03861052|147500608|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|95.0|-0.51|-0.25|||Mixed Models Analysis|||||-0.25|-0.51|<0.001
73977000|NCT03861052|147500609|SUPERIORITY||Least Squares Mean Difference|16.1|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|10.7|21.4|||Mixed Models Analysis|||||21.4|10.7|<0.001
73977001|NCT03861052|147500609|SUPERIORITY||Least Squares Mean Difference|20.6|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|14.9|26.3|||Mixed Models Analysis|||||26.3|14.9|<0.001
73977002|NCT03861052|147500609|SUPERIORITY||Least Squares Mean Difference|23.9|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|18.1|29.7|||Mixed Models Analysis|||||29.7|18.1|<0.001
73977003|NCT03861052|147500610|SUPERIORITY||Least Squares Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|4.22|<|0.001|TWO_SIDED|95.0|11.7|28.2|||Mixed Models Analysis|||||28.2|11.7|<0.001
73977004|NCT03861052|147500610|SUPERIORITY||Least Squares Mean Difference|27.0|STANDARD_ERROR_OF_MEAN|4.59|<|0.001|TWO_SIDED|95.0|18.0|36.0|||Mixed Models Analysis|||||36.0|18.0|<0.001
73948217|NCT02912468|147429435|SUPERIORITY|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 24 SNOT-22.|LS mean difference|-7.44|||<|0.0001|TWO_SIDED|95.0|-8.35|-6.53||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-6.53|-8.35|<.0001
73948218|NCT02912468|147429436|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.61|||<|0.0001|TWO_SIDED|95.0|-3.04|-2.17||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.17|-3.04|<.0001
73948219|NCT02912468|147429437|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.56|||<|0.0001|TWO_SIDED|95.0|8.79|12.34||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||12.34|8.79|<.0001
73948220|NCT02912468|147429438|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.93||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.93|-1.31|<.0001
73948221|NCT02912468|147429439|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.12|||<|0.0001|TWO_SIDED|95.0|-25.17|-17.06||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-17.06|-25.17|<.0001
73948222|NCT02597933|147429473|OTHER||Mean Difference (Final Values)|40.95|STANDARD_ERROR_OF_MEAN|19.38||0.035|TWO_SIDED|95.0|2.88|79.01|||random coefficient regression||The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.|The primary analysis is a restricted maximum likelihood (REML) based approach using a random slope \& intercept model. The analysis included the fixed, categorical effects of treatment, ATA status \& gender, fixed continuous effects of time \& baseline FVC (mL), age and height as well as the treatment-by time \& baseline-by-time interactions. Random effects was included for patient response for both time \& intercept.Within-patient errors are modelled by an unstructured variance-covariance matrix||79.01|2.88|0.0350
73948223|NCT02597933|147429473|OTHER||Mean Difference (Final Values)|43.13||||0.0378|TWO_SIDED|95.0|2.44|83.83|||random coefficient regression|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||"This is a sensitivity analysis (SA) on primary endpoint including only on-trt measurements of FVC \[mL\]. The random coefficient model was used. The analysis included fixed, categorical effects of trt, ATA status \& gender, fixed continuous effects of time \& bl. FVC (mL), age, height, trt -by time \& bl.-by-time interactions. Random effects included for patient response for both time \& intercept.~Within-patient errors were modelled by an Unstructured variance-covariance matrix."||83.83|2.44|0.0378
73977005|NCT03861052|147500610|SUPERIORITY||Least Squares Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|4.68|<|0.001|TWO_SIDED|95.0|22.0|40.4|||Mixed Models Analysis|||||40.4|22.0|<0.001
73977006|NCT03137459|147500656|SUPERIORITY||Risk Difference (RD)|0.059|||||TWO_SIDED|95.0|0.014|0.105|||||Analysis performed using GEE to account for clustering of participants within practices.|||.105|.014|
73977007|NCT03137459|147500656|SUPERIORITY||Odds Ratio (OR)|1.83|||||TWO_SIDED|95.0|1.14|2.93|||||Determined using mixed effects models, accounting for clustering of participants in practices and adjusting for unbalanced covariates: education, employment, stage of change for each ACP behavior|||2.93|1.14|
73977008|NCT03137459|147500657|SUPERIORITY||Risk Difference (RD)|0.082|||||TWO_SIDED|95.0|0.014|0.15|||||Adjusted for clustering|||.150|.014|
73977009|NCT03137459|147500657|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.96|2.0|||||Accounting for clustering and adjusted for covariates as described in primary outcome|||2.0|.96|
74032140|NCT02749721|147617313|OTHER||Pearson's R|-0.18||||0.537|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and PDQ baseline to endpoint percent change||||0.537
73977010|NCT03137459|147500658|SUPERIORITY||Risk Difference (RD)|0.133|||||TWO_SIDED|95.0|0.066|0.201|||||Accounting for clustering|||.201|.066|
73977011|NCT03137459|147500658|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|1.22|2.47|||||Accounting for clustering and adjusted for covariates as presenting for primary outcome|||2.47|1.22|
73977012|NCT03137459|147500659|SUPERIORITY||Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|-0.05|0.188||||||||.188|-.05|
74032141|NCT02749721|147617313|OTHER||Pearson's R|0.476||||0.195|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and PDQ baseline to endpoint percent change||||0.195
74032142|NCT02749721|147617313|OTHER||Pearson's R|0.594||||0.015|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and PDQ baseline to endpoint percent change||||0.015
74032143|NCT02749721|147617313|OTHER||Pearson's R|-0.009||||0.972|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and PDQ baseline to endpoint percent change||||0.972
73870508|NCT04737278|147284745|OTHER|||||||0.11||||||Comparison of GGT activities in blood of two arms: Cunermuspir and Placebo on Day 28|Wilcoxon (Mann-Whitney)|||comparison between placebo and Cunermuspir at day 28||||0.11
73870509|NCT04737278|147284745|OTHER|||||||0.01|||||||Wilcoxon Signed Rank|||Comparison of GGT activities in participants' blood at baseline and on day 28||||0.01
73948224|NCT02597933|147429473|OTHER||Mean Difference (Final Values)|30.0||||0.1046|TWO_SIDED|95.0|-6.22|66.22|||random coefficient regression|||In multiple imputation SA 1, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from corresponding trt group who prematurely disc. trial drug but had wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with wk 52 FVC value who prematurely disc. trial drug with most severe declines.The imputation model was similar to statistical model of PA.||66.22|-6.22|0.1046
73948225|NCT02597933|147429473|OTHER||Mean Difference (Final Values)|32.93||||0.074|TWO_SIDED|95.0|-3.19|69.06|||random coefficient regression|||In multiple imputation SA 2, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from pl. group who prematurely disc. trial drug but had a wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with a wk 52 FVC value who prematurely disc. trial drug with most severe declines. The imputation model was similar to the statistical model of the PA||69.06|-3.19|0.0740
74032144|NCT02749721|147617313|OTHER||Pearson's R|0.067||||0.785|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline scores||||0.785
73948226|NCT02597933|147429473|OTHER||Mean Difference (Final Values)|33.86||||0.0644|TWO_SIDED|95.0|-2.03|69.75|||random coefficient regression|||In multiple imputation SA 3, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming a similar rate of FVC decline as in all pts in the pl. group who were included in the PA. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming a similar rate of FVC decline as in all placebo patients included in the primary analysis with the most severe declines. The imputation model was similar to the statistical model of the PA.||69.75|-2.03|0.0644
73948227|NCT02597933|147429473|OTHER||Mean Difference (Final Values)|40.95||||0.0351|TWO_SIDED|95.0|2.88|79.01|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status, the fixed continuous effects of time, baseline FVC (mL), and the treatment-by-time and baseline-by-time interactions.Random effects was included for patient response for both time and intercept.||79.01|2.88|0.0351
73948228|NCT02597933|147429473|OTHER||Mean Difference (Final Values)|40.98||||0.0349|TWO_SIDED|95.0|2.92|79.04|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status (Positive / Negative), gender and mycophenolate mofetil /sodium background therapy use (Yes / No), fixed continuous effects of time, age , height and baseline FVC (mL), the treatment-by-time and baseline-by-time interactions. Random effects was included for patient response for both time and intercept||79.04|2.92|0.0349
73948229|NCT02597933|147429474|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.37||0.5785|TWO_SIDED|95.0|-0.94|0.53|||MMRM|||The mixed model repeated measures (MMRM) approach was used. The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||0.53|-0.94|0.5785
73948230|NCT02597933|147429475|OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|1.24||0.1711|TWO_SIDED|95.0|-0.73|4.12|||MMRM|The MMRM model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||4.12|-0.73|0.1711
73948231|NCT02597933|147429476|OTHER||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|0.54||0.0331|TWO_SIDED|1.15|0.09|2.21|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||"Based on a random coefficient regression with fixed categorical effects of treatment, ATA status, fixed continuous effects of time, baseline FVC \[% pred\], \& including treatment-by-time and baseline-by-time interactions. Random effect was included for patient specific intercept \& time.~Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-Components variance-covariance matrix."||2.21|0.09|0.0331
74032145|NCT02749721|147617313|OTHER||Pearson's R|-0.129||||0.646|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline scores||||0.646
74032146|NCT02749721|147617313|OTHER||Pearson's R|0.364||||0.182|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline scores||||0.182
74032147|NCT02749721|147617313|OTHER||Pearson's R|-0.414||||0.069|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline scores||||0.069
73870510|NCT04737278|147284745|OTHER|||||||0.97|||||||Wilcoxon Signed-Rank|||Comparison of GGT activity in blood between Placebo Arm participants at baseline and on day 28||||0.97
73870511|NCT04737278|147284746|OTHER|||||||0.03|||||||ANCOVA|||Between group comparisons were made using ANCOVA||||0.03
73870512|NCT04737278|147284746|OTHER|||||||0.1|||||||t-test, 2 sided|||comparison of baseline with day 28||||0.10
73870513|NCT04737278|147284746|OTHER|||||||0.89|||||||t-test, 2 sided|||comparison between baseline and day 28 serum copper concentrations in the Placebo Arm||||0.89
73870514|NCT01504412|147284750|SUPERIORITY||Hazard Ratio (HR)|-0.42||||0.1995|TWO_SIDED|95.0|-0.99|0.15||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.15|-0.99|0.1995
73870515|NCT01504412|147284750|SUPERIORITY||Hazard Ratio (HR)|-0.37||||0.2886|TWO_SIDED|95.0|-0.93|0.2||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.20|-0.93|0.2886
73870516|NCT01504412|147284750|SUPERIORITY||Hazard Ratio (HR)|-0.3||||0.4704|TWO_SIDED|95.0|-0.87|0.27||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.27|-0.87|0.4704
73870517|NCT01504412|147284751|SUPERIORITY||Least squares mean difference|-5.2||||0.0691|TWO_SIDED|95.0|-10.8|0.4|||ANCOVA|||This analysis assessed placebo vs DS-5565 10 mg/day for the visual analog scale.||0.4|-10.8|0.0691
73948232|NCT02597933|147429477|OTHER||Mean Difference (Final Values)|46.41|STANDARD_ERROR_OF_MEAN|19.51||0.0177|TWO_SIDED|95.0|8.09|84.73|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||84.73|8.09|0.0177
73948233|NCT02597933|147429478|OTHER||Mean Difference (Final Values)|-6.28|STANDARD_ERROR_OF_MEAN|8.39||0.4547|TWO_SIDED|95.0|-22.77|10.21|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||10.21|-22.77|0.4547
73948234|NCT02597933|147429479|OTHER||Hazard Ratio (HR)|1.16||||0.7535|TWO_SIDED|95.0|0.47|2.84|||Regression, Cox|Based on Cox's regression model (Wald test), stratified by ATA status.||||2.84|0.47|0.7535
73948235|NCT02597933|147429480|OTHER||Odds Ratio (OR)|1.03||||0.9115|TWO_SIDED|95.0|0.57|1.88|||Cochran-Mantel-Haenszel|||The comparison between both treatment groups was performed using a Cochran-Mantel-Haenszel test. CRISS score at Week 52 was transformed into 100 binary responder endpoints using multiple imputation. These were analyzed using a Cochran-Mantel-Haenszel test, stratified by ATA status OR and the 95% confidence interval (CI) as obtained from all 100 imputations were combined using Rubin´s rule.|Missing values were imputed using worst case, i.e. considered having disease progression.|1.88|0.57|0.9115
73948236|NCT02597933|147429481|OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.76||0.5668|TWO_SIDED|95.0|-1.94|1.06|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||1.06|-1.94|0.5668
73948237|NCT02597933|147429482|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.5914|TWO_SIDED|95.0|-0.16|0.09|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||0.09|-0.16|0.5914
73948238|NCT02597933|147429483|OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.034||0.3447|TWO_SIDED|95.0|-0.035|0.099|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||0.099|-0.035|0.3447
73948239|NCT02597933|147429484|OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.58||0.2727|TWO_SIDED|95.0|-0.51|1.79|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||1.79|-0.51|0.2727
73948240|NCT02224482|147429505|SUPERIORITY|||||||0.9634|||||||Mixed Models Analysis|||||||.9634
73948241|NCT02224482|147429506|SUPERIORITY|||||||0.5214|||||||Mixed Models Analysis|||||||.5214
73977013|NCT03137459|147500659|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.72|1.85|||||Accounting for clustering and adjusting for covariates as described for primary outcome|||1.85|.72|
73948242|NCT02224482|147429507|SUPERIORITY|||||||0.4875|||||||Mixed Models Analysis|||||||.4875
73948243|NCT02224482|147429508|SUPERIORITY|||||||0.7938|||||||Mixed Models Analysis|||||||.7938
73977014|NCT04921358|147500682|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.75|1.39|||||Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% Tumor Cells (TC) vs \>=1% TC).|||1.39|0.75|
73977015|NCT04921358|147500683|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.62|1.07|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% TC vs \>=1% TC).|||1.07|0.62|
74032148|NCT02749721|147617313|OTHER||Pearson's R|-0.416||||0.068|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline scores||||0.068
73948244|NCT02224482|147429509|SUPERIORITY|||||||0.6765|||||||Mixed Models Analysis|||||||.6765
73948245|NCT02224482|147429510|SUPERIORITY|||||||0.7061|||||||Mixed Models Analysis|||||||.7061
73948246|NCT02224482|147429511|SUPERIORITY|||||||0.7593|||||||Mixed Models Analysis|||||||.7593
73948247|NCT01225822|147429517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.577|0.244|<0.0001
73977016|NCT04921358|147500684|OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% TC vs \>=1% TC).|||0.83|0.50|
73977017|NCT02372799|147500692|SUPERIORITY||LSMD|-0.4||||0.7662|TWO_SIDED|95.0|-3.08|2.27|||MMRM|||||2.27|-3.08|0.7662
73977018|NCT02372799|147500692|SUPERIORITY||LSMD|-2.39||||0.1433|TWO_SIDED|95.0|-5.6|0.81|||MMRM|||||0.81|-5.60|0.1433
73977019|NCT02372799|147500693|SUPERIORITY||LSMD|-0.04||||0.7387|TWO_SIDED|95.0|-0.31|0.22|||MMRM|||||0.22|-0.31|0.7387
73977020|NCT02372799|147500693|SUPERIORITY||LSMD|-0.2||||0.2158|TWO_SIDED|95.0|-0.52|0.12|||MMRM|||||0.12|-0.52|0.2158
73977021|NCT01583166|147500714|OTHER|||||||0.837|||||||Fisher Exact|||||||0.837
73977022|NCT03559205|147500718|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.96|TWO_SIDED|95.0|-0.74|0.7|||t-test, 2 sided|||2 Week Analysis||0.70|-0.74|0.96
73870518|NCT01504412|147284751|SUPERIORITY||Least squares mean difference|-5.4||||0.0577|TWO_SIDED|95.0|-10.9|0.2|||ANCOVA|||This analysis assessed placebo vs DS-5565 20 mg/day for the visual analog scale.||0.2|-10.9|0.0577
73870519|NCT01504412|147284751|SUPERIORITY||Least squares mean difference|-7.4||||0.0093|TWO_SIDED|95.0|-13.0|-1.8|||ANCOVA|||This analysis assessed placebo vs DS-5565 30 mg/day for the visual analog scale.||-1.8|-13.0|0.0093
73870520|NCT02974257|147284752|OTHER|Linear mixed-effects model with an independent variance-covariance matrix to account for the correlation of within-patient repeated measures was used and linear contrasts were used to estimate the mean difference between treatment arms at 48 hours.|Mean Difference (Final Values)|1.5||||0.9|TWO_SIDED|95.0|-3.1|6.1||Global p-value from the mixed model.|Mixed Models Analysis|If patients died before 48 hours lactate levels were imputed by carrying forward the last known value before the event with a 20% increase||||6.1|-3.1|0.9
73870521|NCT02974257|147284753|OTHER||Mean Difference (Final Values)|-0.36||||0.42|TWO_SIDED|95.0|-1.29|0.56|||Regression, Linear|||AUC-VO2 normally distributed, used a linear regression model to compare mean AUC-VO2 between treatment groups controlling for average temperature.||0.56|-1.29|0.42
73948248|NCT01225822|147429517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.778|0.344|0.0015
73948249|NCT01225822|147429517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.||1.473|0.599|0.7856
73948250|NCT01225822|147429517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.727|0.302|0.0007
73977023|NCT03559205|147500719|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.9|TWO_SIDED|95.0|-2.31|2.04|||t-test, 2 sided|||Baseline||2.04|-2.31|0.90
73977024|NCT03559205|147500719|SUPERIORITY||Mean Difference (Final Values)|2.01||||0.21|TWO_SIDED|95.0|-1.17|5.19|||t-test, 2 sided|||2 Week Analysis||5.19|-1.17|0.21
73977025|NCT03559205|147500719|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.63|TWO_SIDED|95.0|-2.95|4.83|||t-test, 2 sided|||3-Month||4.83|-2.95|0.63
73977026|NCT03559205|147500720|SUPERIORITY||Mean Difference (Final Values)|2.63||||0.15|TWO_SIDED|95.0|-1.0|6.26|||t-test, 2 sided|||Baseline||6.26|-1.00|0.15
73977027|NCT03559205|147500720|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.3|TWO_SIDED|95.0|-2.02|6.45|||t-test, 2 sided|||Week 2 analysis||6.45|-2.02|0.30
73977028|NCT03559205|147500720|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.85|TWO_SIDED|95.0|-4.89|5.9|||t-test, 2 sided|||3-Month||5.90|-4.89|0.85
73977029|NCT03559205|147500721|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.72|TWO_SIDED|95.0|-0.51|0.74|||t-test, 2 sided|||Care and respect||0.74|-0.51|0.72
74032149|NCT02749721|147617313|OTHER||Pearson's R|-0.023||||0.929|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.929
73977030|NCT03559205|147500721|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.46|TWO_SIDED|95.0|-0.38|0.83|||t-test, 2 sided|||Understanding \& engagement||0.83|-0.38|0.46
73977031|NCT03559205|147500722|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.3|TWO_SIDED|95.0|-0.13|0.42|||t-test, 2 sided|||2-weeks||0.42|-0.13|0.30
73870522|NCT02974257|147284754|OTHER||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.9|0.3||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH specific activity between thiamine and placebo groups at 48 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model.||||0.3|-0.9|0.07
73870523|NCT02381015|147284755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|||||||0.29
73870524|NCT02381015|147284756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|||||||Chi-squared|||||||0.35
73870525|NCT02381015|147284757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|||||||0.29
73870526|NCT02381015|147284758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|||||||Kruskal-Wallis|||||||0.49
73870527|NCT02381015|147284759|OTHER||Beta|93.5|STANDARD_ERROR_OF_MEAN|1.55||0.42|TWO_SIDED||||||ANOVA|||The statistical analysis shows the relation between risk given and risk recall at the immediate post results assessment for the total number of participants.||||0.42
73870528|NCT02381015|147284760|OTHER||Beta|94.7|STANDARD_ERROR_OF_MEAN|2.93||0.33|TWO_SIDED||||||ANOVA|||||||0.33
73870529|NCT01449006|147284761|SUPERIORITY_OR_OTHER|||||||0.05||||||This pilot study was conducted to generate effect sizes for a potential larger investigation. The study design and small sample size had limited power to detect a statistically significant effect at p\<0.05, so no p-value threshold was strictly set.|Mixed Models Analysis|41 data points included (control n=14; maraviroc: n=27); n=1 control did not attend 12-month visit.||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm\*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.||||0.05
73870530|NCT01449006|147284761|SUPERIORITY_OR_OTHER||Cohen's d|0.77|||||TWO_SIDED|90.0|-0.19|1.71|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 6-months was assessed by generating Cohen's d statistic and 90% confidence interval (CI) around the estimate.||1.71|-0.19|
73870531|NCT01449006|147284761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|90.0|-0.47|1.55|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 12-months was assessed by generating Cohen's d statistic and 90%CI around the estimate.||1.55|-0.47|
73977032|NCT03559205|147500722|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.38|TWO_SIDED|95.0|-0.2|0.52|||t-test, 2 sided|||3-months||0.52|-0.20|0.38
73977033|NCT03559205|147500723|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.61|TWO_SIDED|95.0|-1.48|0.88|||t-test, 2 sided|||||0.88|-1.48|0.61
73977034|NCT00887224|147500742|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Significance declared if p-value ≤0.05. The estimated probability obtained via Kaplan-Meier estimate.|Log Rank|||||||<0.001
73977035|NCT00887224|147500744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9627|TWO_SIDED|95.0|-0.09|0.08||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.08|-0.09|0.9627
73977036|NCT00887224|147500744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.1046|TWO_SIDED|95.0|-0.02|0.21||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||0.21|-0.02|0.1046
73977037|NCT00887224|147500744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.0228|TWO_SIDED|95.0|0.02|0.25||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||0.25|0.02|0.0228
73977038|NCT00887224|147500744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.0064|TWO_SIDED|95.0|0.05|0.29||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||0.29|0.05|0.0064
73977039|NCT00887224|147500744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.001|TWO_SIDED|95.0|0.11|0.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||0.39|0.11|<0.001
73977040|NCT00887224|147500744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.12|0.43||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||0.43|0.12|<0.001
73977041|NCT00887224|147500744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001|TWO_SIDED|95.0|0.19|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||0.47|0.19|<0.001
73977042|NCT00887224|147500744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001|TWO_SIDED|95.0|0.17|0.49||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||0.49|0.17|<0.001
73977043|NCT00887224|147500744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|||<|0.001|TWO_SIDED|95.0|0.25|0.62||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||0.62|0.25|<0.001
73977044|NCT00887224|147500744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||0.61|0.28|<0.001
73977045|NCT00887224|147500745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8853|TWO_SIDED|95.0|-0.41|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.47|-0.41|0.8853
73977046|NCT00887224|147500745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.0081|TWO_SIDED|95.0|0.23|1.52||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||1.52|0.23|0.0081
74032150|NCT02749721|147617313|OTHER||Pearson's R|-0.074||||0.802|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.802
73977047|NCT00887224|147500745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.0038|TWO_SIDED|95.0|0.28|1.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||1.47|0.28|0.0038
73977048|NCT00887224|147500745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.76|2.03||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||2.03|0.76|<0.001
73977049|NCT00887224|147500745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|0.86|2.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||2.39|0.86|<0.001
73977050|NCT00887224|147500745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|0.83|2.54||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||2.54|0.83|<0.001
73977051|NCT00887224|147500745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|||<|0.001|TWO_SIDED|95.0|1.23|2.86||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||2.86|1.23|<0.001
73870532|NCT01449006|147284762|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||Change in CSF neopterin levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.82
73870533|NCT01449006|147284763|SUPERIORITY_OR_OTHER|||||||0.49|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.49
73870534|NCT01449006|147284763|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.94
73948251|NCT01225822|147429517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.98|0.427|0.0401
73948252|NCT01225822|147429517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||1.817|0.859|0.2446
73977052|NCT00887224|147500745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|||<|0.001|TWO_SIDED|95.0|1.06|2.84||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||2.84|1.06|<0.001
73977053|NCT00887224|147500745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.31|3.3||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||3.30|1.31|<0.001
73977054|NCT00887224|147500745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|||<|0.001|TWO_SIDED|95.0|1.39|3.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||3.32|1.39|<0.001
73977055|NCT00887224|147500746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9142|TWO_SIDED|95.0|-0.24|0.27||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.27|-0.24|0.9142
73977056|NCT00887224|147500746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.0069|TWO_SIDED|95.0|0.15|0.91||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||0.91|0.15|0.0069
73977057|NCT00887224|147500746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0023|TWO_SIDED|95.0|0.21|0.95||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||0.95|0.21|0.0023
74032151|NCT02749721|147617313|OTHER||Pearson's R|0.518||||0.153|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.153
74032152|NCT02749721|147617313|OTHER||Pearson's R|0.268||||0.298|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.298
74032153|NCT02749721|147617313|OTHER||Pearson's R|-0.001||||0.996|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.996
74032154|NCT02749721|147617313|OTHER||Pearson's R|0.242||||0.531|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and WLQ baseline scores||||0.531
74032155|NCT02749721|147617313|OTHER||Pearson's R|-0.598||||0.21|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and WLQ baseline scores||||0.210
74032156|NCT02749721|147617313|OTHER||Pearson's R|0.054||||0.899|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and WLQ baseline scores||||0.899
74032157|NCT02749721|147617313|OTHER||Pearson's R|0.568||||0.087|TWO_SIDED||||||Pearson's correlation|||||||0.087
73870535|NCT01449006|147284763|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.80
73870536|NCT01449006|147284763|SUPERIORITY_OR_OTHER|||||||0.72|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.72
73870537|NCT01449006|147284764|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.95
73870538|NCT01449006|147284764|SUPERIORITY_OR_OTHER|||||||0.66|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.66
73870539|NCT01449006|147284764|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.56
73870540|NCT01449006|147284764|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.29
73870541|NCT01449006|147284764|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.95
73870542|NCT03350815|147284765|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.28|2.25||No P value as no hypothesis was tested|Regression, Logistic|||Statistical analysis (logistic regression) of ASDAS inactive disease response by visit - in Treatment Period 2 (nonresponder imputation)||2.25|0.28|
73870543|NCT03350815|147284766|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|2.08|||||TWO_SIDED|95.0|0.5|8.66||No P value as no hypothesis was tested|Regression, Logistic|||Statistical analysis (logistic regression) of reduction in ASDAS \>= 1.1 response by visit - in Treatment Period 2 (nonresponder imputation)||8.66|0.50|
73948253|NCT01225822|147429518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.577|0.244|<0.0001
73948254|NCT01225822|147429518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.778|0.344|0.0015
73948255|NCT01225822|147429518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.||1.473|0.599|0.7856
73948256|NCT01225822|147429518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.727|0.302|0.0007
73948257|NCT01225822|147429518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.98|0.427|0.0401
73948258|NCT01225822|147429518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||1.817|0.859|0.2446
73948259|NCT01225822|147429519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.334||||0.0373||95.0|0.199|0.938|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||0.938|0.199|0.0373
73948260|NCT01225822|147429519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.837||||0.6659||95.0|0.374|1.875|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||1.875|0.374|0.6659
73948261|NCT01225822|147429519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.505||||0.1882||95.0|0.183|1.397|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.||1.397|0.183|0.1882
73948262|NCT01225822|147429519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.805||||0.5566||95.0|0.39|1.66|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.66|0.39|0.5566
73948263|NCT01225822|147429519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.674||||0.3253||95.0|0.307|1.48|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.48|0.307|0.3253
73948264|NCT01225822|147429519|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.269||||0.0114||95.0|0.097|0.744|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||0.744|0.097|0.0114
73948265|NCT01225822|147429520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.332||||0.036||95.0|0.118|0.931|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||0.931|0.118|0.036
73977058|NCT00887224|147500746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|||<|0.001|TWO_SIDED|95.0|0.49|1.28||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||1.28|0.49|<0.001
73948266|NCT01225822|147429520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.687||||0.3884||95.0|0.293|1.611|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||1.611|0.293|0.3884
73948267|NCT01225822|147429520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.616||||0.3674||95.0|0.215|1.766|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.||1.766|0.215|0.3674
73977059|NCT00887224|147500746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88|||<|0.001|TWO_SIDED|95.0|0.43|1.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||1.32|0.43|<0.001
73948268|NCT01225822|147429520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.809||||0.5663||95.0|0.393|1.668|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.668|0.393|0.5663
73948269|NCT01225822|147429520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.556||||0.1678||95.0|0.242|1.28|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.28|0.242|0.1678
74032158|NCT02749721|147617313|OTHER||Pearson's R|0.568||||0.087|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and WLQ baseline scores||||0.087
73948270|NCT01225822|147429520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.269||||0.0113||95.0|0.097|0.743|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||0.743|0.097|0.0113
73948271|NCT01225822|147429521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.818||||0.0077||95.0|2.077|120.474|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint||120.474|2.077|0.0077
73948272|NCT01225822|147429521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.907||||0.0062||95.0|2.229|128.238|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint||128.238|2.229|0.0062
73948273|NCT01225822|147429521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.7192||95.0|0.567|2.276|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as for primary endpoint||2.276|0.567|0.7192
73948274|NCT01225822|147429521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.121||||0.0472||95.0|0.015|0.974|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||0.974|0.015|0.0472
73948275|NCT01225822|147429521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.049||||0.1043||95.0|0.862|4.868|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||4.868|0.862|0.1043
73948276|NCT01225822|147429521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.917||||0.1448||95.0|0.799|4.597|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||4.597|0.799|0.1448
73948277|NCT01225822|147429523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.871||||0.0063|TWO_SIDED|95.0|2.221|128.142|||Regression, Logistic|||||128.142|2.221|0.0063
73977060|NCT00887224|147500746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.58|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||1.58|0.58|<0.001
73977061|NCT00887224|147500746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.66|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||1.58|0.66|<0.001
73977062|NCT00887224|147500746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||<|0.001|TWO_SIDED|95.0|0.76|1.83||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||1.83|0.76|<0.001
73977063|NCT00887224|147500746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.001|TWO_SIDED|95.0|0.7|1.76||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||1.76|0.70|<0.001
73977064|NCT00887224|147500746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|||<|0.001|TWO_SIDED|95.0|0.75|1.79||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||1.79|0.75|<0.001
73977065|NCT00887224|147500747|SUPERIORITY_OR_OTHER||Adjusted odds ratio|2.85|||<|0.0001|TWO_SIDED|95.0|1.93|4.2||Obtained from logistic regression analysis using Remission (Yes/No) at each time point as a response variable; logistic model with treatment and sites as factors and baseline HAM-D17 total score as covariate.|Regression, Logistic|||Wald 95% CI for adjusted odds ratio.||4.20|1.93|<0.0001
73948278|NCT01225822|147429523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.338||||0.0025|TWO_SIDED|95.0|2.983|167.268|||Regression, Logistic|||||167.268|2.983|0.0025
73948279|NCT01225822|147429523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.919||||0.7973|TWO_SIDED|95.0|0.483|1.75|||Regression, Logistic|||||1.750|0.483|0.7973
73977066|NCT00887224|147500748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14|||<|0.001|TWO_SIDED|95.0|-3.03|-1.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||-1.24|-3.03|<0.001
73948280|NCT01225822|147429523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.068||||0.0097|TWO_SIDED|95.0|0.009|0.522|||Regression, Logistic|||||0.522|0.009|0.0097
73977067|NCT00887224|147500748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|||<|0.001|TWO_SIDED|95.0|-3.29|-1.34||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||-1.34|-3.29|<0.001
74032159|NCT02749721|147617313|OTHER||Pearson's R|0.231||||0.55|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and WLQ baseline to endpoint percent change||||0.550
73948281|NCT01225822|147429523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.522||||0.2375|TWO_SIDED|95.0|0.758|3.058|||Regression, Logistic|||||3.058|0.758|0.2375
73977068|NCT00887224|147500749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.6772|TWO_SIDED|95.0|-3.82|5.87||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Absenteeism||5.87|-3.82|0.6772
73977069|NCT00887224|147500749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.9059|TWO_SIDED|95.0|-5.91|5.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Absenteeism||5.24|-5.91|0.9059
74032160|NCT02749721|147617313|OTHER||Pearson's R|0.158||||0.766|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and WLQ baseline to endpoint percent change||||0.766
74032161|NCT02749721|147617313|OTHER||Pearson's R|-0.406||||0.498|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and WLQ baseline to endpoint percent change||||0.498
74032162|NCT02749721|147617313|OTHER||Pearson's R|0.221||||0.599|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and WLQ baseline to endpoint percent change||||0.599
74032163|NCT02749721|147617313|OTHER||Pearson's R|0.679||||0.064|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and WLQ baseline to endpoint percent change||||0.064
74032164|NCT02749721|147617314|OTHER||Pearson's R|-0.038||||0.881|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-28 baseline scores||||0.881
73948282|NCT01225822|147429523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.7104|TWO_SIDED|95.0|0.55|2.403|||Regression, Logistic|||||2.403|0.550|0.7104
73948283|NCT04195880|147429556|SUPERIORITY||||||<|0.05|TWO_SIDED|5.0|||||negative-binomial regression coefficient|||We assumed the average monthly pre-intervention hospitalization rates of intervention and control CLCs were equal, so only average monthly post-intervention hospitalization rates might diverge. Each CLC had its own start month and contributed 18 months pre-intervention and 18 months post-intervention. Hospitalizations rates were modeled using a multilevel negative-binomial regression because it allows for over-dispersion, which is commonly observed with medical events such as a count.||||<.05
73948284|NCT01693692|147429558|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.25||0.1683|ONE_SIDED|95.0||0.2|||ANCOVA|||||0.2||0.1683
73948285|NCT01693692|147429558|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.25||0.0277|ONE_SIDED|95.0||-0.1|||ANCOVA|||||-0.1||0.0277
73948286|NCT01693692|147429559|SUPERIORITY||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|2.48||0.2637|ONE_SIDED|95.0||2.5|||ANCOVA|||||2.5||0.2637
73948287|NCT01693692|147429559|SUPERIORITY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|2.47||0.0097|ONE_SIDED|95.0||-1.7|||ANCOVA|||||-1.7||0.0097
73948288|NCT01693692|147429560|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.16||0.0639|ONE_SIDED|95.0||0.0|||ANCOVA|||||0.0||0.0639
73948289|NCT01693692|147429560|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.007|ONE_SIDED|95.0||-0.1|||ANCOVA|||||-0.1||0.0070
73948290|NCT00708721|147429627|OTHER||Maximum Tolerated Dose|1.0|||||TWO_SIDED||||||||Based on cytopenias observed at day 10 (Phase 1 trial only), and the Phase II dose was determined to be 1 mg per day for 7 consecutive days given on a 28 day cycle.|||||
73948291|NCT04105972|147429634|SUPERIORITY||Least Squares (LS) Mean Difference|15.9|||<|0.0001|TWO_SIDED|95.0|11.7|20.1|||Mixed-effects Model for Repeated Measure|||||20.1|11.7|< 0.0001
73948292|NCT04105972|147429635|SUPERIORITY||LS Mean Difference|10.2|||<|0.0001|TWO_SIDED|95.0|8.2|12.1|||Mixed-effects Model for Repeated Measure|||||12.1|8.2|<0.0001
73948293|NCT04105972|147429636|SUPERIORITY||LS Mean Difference|-42.8|||||TWO_SIDED|95.0|-46.2|-39.3||||||||-39.3|-46.2|
73948294|NCT02341287|147429638|SUPERIORITY||Mean Difference (Net)|14.01|STANDARD_DEVIATION|19.4||0.023|TWO_SIDED|95.0|2.29|25.74||Paired t-test of control average sleep latency vs. heated glove average sleep latency as measured by actigraph.|t-test, 2 sided|||||25.74|2.29|.023
73948295|NCT02341287|147429639|SUPERIORITY|Paired t-test of control average sleep latency vs. heated glove average sleep latency as measured by sleep log.|Mean Difference (Net)|13.51|STANDARD_DEVIATION|16.91|<|0.014|TWO_SIDED|95.0|3.29|23.73|||t-test, 2 sided|||||23.73|3.29|<0.014
73977070|NCT00887224|147500749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.91||||0.0414|TWO_SIDED|95.0|0.27|13.55||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Presenteeism||13.55|0.27|0.0414
73948296|NCT02687412|147429640|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
74032165|NCT02749721|147617314|OTHER||Pearson's R|0.299||||0.279|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-28 baseline scores||||0.279
74032166|NCT02749721|147617314|OTHER||Pearson's R|0.538||||0.039|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-28 baseline scores||||0.039
73948297|NCT02687412|147429641|SUPERIORITY||Mean Difference (Final Values)|-4041.0|STANDARD_ERROR_OF_MEAN|1831.042||0.029|TWO_SIDED|95.0|-7672.301|-411.065|||t-test, 2 sided|||||-411.065|-7672.301|0.029
73948298|NCT02687412|147429642|SUPERIORITY||Mean Difference (Final Values)|20.3739|STANDARD_ERROR_OF_MEAN|6.4198||0.002|TWO_SIDED|95.0|7.6414|33.1065|||t-test, 2 sided|||||33.1065|7.6414|0.002
73948299|NCT02687412|147429643|SUPERIORITY|||||||0.014|||||||Chi-squared|||||||0.014
73948300|NCT02687412|147429644|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||0.034
73948301|NCT02687412|147429645|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73948302|NCT02687412|147429646|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73948303|NCT02687412|147429647|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73948304|NCT02687412|147429648|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73948305|NCT02687412|147429649|SUPERIORITY||Mean Difference (Final Values)|-0.10046|STANDARD_ERROR_OF_MEAN|0.1915||0.601|TWO_SIDED|95.0|-0.4819|0.2817|||t-test, 2 sided|||||0.2817|-0.4819|0.601
73948306|NCT02687412|147429650|SUPERIORITY||Mean Difference (Final Values)|164.746|STANDARD_ERROR_OF_MEAN|317.79||0.605|TWO_SIDED|95.0|-465.0|794.0|||t-test, 2 sided|||||794|-465|0.605
73948307|NCT00584701|147429694|SUPERIORITY_OR_OTHER||Dfiference in exon expression|1.5|||<|0.001||||||"Expression difference \>\|1.5\| with p-value adjusted for multiple comparisons."|ANCOVA|Between-group gene expression profiles compared between high versus low responders, controlling for age, gender and batch.||||||<.001
73948308|NCT01161472|147429696|SUPERIORITY_OR_OTHER||Least square (LS) Mean Difference|-0.0285|STANDARD_ERROR_OF_MEAN|0.018||0.1198|TWO_SIDED|95.0|-0.0647|0.0077|||ANCOVA|||Analysis of Covariance (ANCOVA) was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0077|-0.0647|0.1198
73948309|NCT01161472|147429696|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0203|STANDARD_ERROR_OF_MEAN|0.0173||0.2459|TWO_SIDED|95.0|-0.0551|0.0145|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0145|-0.0551|0.2459
73948310|NCT01161472|147429698|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0037|STANDARD_ERROR_OF_MEAN|0.0115||0.7502|TWO_SIDED|95.0|-0.0268|0.0194|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0194|-0.0268|0.7502
73948311|NCT01161472|147429698|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0085|STANDARD_ERROR_OF_MEAN|0.0119||0.4785|TWO_SIDED|95.0|-0.0325|0.0154|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0154|-0.0325|0.4785
73948312|NCT01161472|147429700|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0035|STANDARD_ERROR_OF_MEAN|0.0265||0.8944|TWO_SIDED|95.0|-0.0569|0.0498|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0498|-0.0569|0.8944
74032167|NCT02749721|147617314|OTHER||Pearson's R|-0.018||||0.94|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-28 baseline scores||||0.940
74032168|NCT02749721|147617314|OTHER||Pearson's R|0.107||||0.65|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-28 baseline scores||||0.65
73948313|NCT01161472|147429700|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0209|STANDARD_ERROR_OF_MEAN|0.0263||0.4308|TWO_SIDED|95.0|-0.032|0.0738|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0738|-0.0320|0.4308
73948314|NCT01161472|147429702|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6629|STANDARD_ERROR_OF_MEAN|12.4945||0.7707|TWO_SIDED|95.0|-21.4729|28.7987|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||28.7987|-21.4729|0.7707
73948315|NCT01161472|147429702|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.921|STANDARD_ERROR_OF_MEAN|12.4482||0.1162|TWO_SIDED|95.0|-44.9634|5.1215|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||5.1215|-44.9634|0.1162
73948316|NCT01161472|147429704|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0068|STANDARD_ERROR_OF_MEAN|4.8707||0.9989|TWO_SIDED|95.0|-9.8297|9.8433|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||9.8433|-9.8297|0.9989
73948317|NCT01161472|147429704|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6251|STANDARD_ERROR_OF_MEAN|5.0346||0.7485|TWO_SIDED|95.0|-11.7926|8.5425|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||8.5425|-11.7926|0.7485
73977071|NCT00887224|147500749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.24||||0.0129|TWO_SIDED|95.0|1.77|14.71||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Presenteeism||14.71|1.77|0.0129
73977072|NCT00887224|147500749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.48||||0.0402|TWO_SIDED|95.0|0.34|14.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Work Productivity Loss||14.61|0.34|0.0402
73977073|NCT00887224|147500749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48||||0.0187|TWO_SIDED|95.0|1.43|15.53||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Work Productivity Loss||15.53|1.43|0.0187
73977074|NCT00887224|147500749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.57|||<|0.001|TWO_SIDED|95.0|3.33|11.8||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Activity Impairment||11.80|3.33|<0.001
74032169|NCT02749721|147617314|OTHER||Pearson's R|0.247||||0.34|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-28 baseline to endpoint percentage change||||0.340
73948318|NCT01161472|147429706|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2684|STANDARD_ERROR_OF_MEAN|0.8243||0.7458|TWO_SIDED|95.0|-1.3788|1.9157|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||1.9157|-1.3788|0.7458
73948319|NCT01161472|147429706|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0661|STANDARD_ERROR_OF_MEAN|0.8277||0.9366|TWO_SIDED|95.0|-1.7202|1.588|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||1.5880|-1.7202|0.9366
73948320|NCT01118455|147429744|SUPERIORITY_OR_OTHER|||||||0.507|||||||Cochran-Mantel-Haenszel|||||||0.507
73948321|NCT01118455|147429744|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Cochran-Mantel-Haenszel|||||||0.220
73948322|NCT01118455|147429744|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Cochran-Mantel-Haenszel|||||||0.168
73948323|NCT01118455|147429744|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Cochran-Mantel-Haenszel|||||||0.620
73948324|NCT01118455|147429745|SUPERIORITY_OR_OTHER|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||||||0.727
73948325|NCT01118455|147429745|SUPERIORITY_OR_OTHER|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
73948326|NCT01118455|147429745|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
73977075|NCT00887224|147500749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.62|||<|0.001|TWO_SIDED|95.0|3.14|12.1||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Activity Impairment||12.10|3.14|<0.001
73977076|NCT03883828|147500768|SUPERIORITY||Multivariable Linear Regression|-0.45||||0.004|TWO_SIDED|95.0|-0.75|-0.15||Two-sided p-values equal to or less than 0.05 were considered statistically significant|Fisher Exact|||||-0.15|-0.75|0.004
73977077|NCT03883828|147500769|SUPERIORITY|||||||0.2||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Symptoms Domain||||||0.20
73977078|NCT03883828|147500769|SUPERIORITY|||||||0.05||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Emotions Domain||||||0.05
73977079|NCT03883828|147500769|SUPERIORITY|||||||0.73||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Functioning Domain||||||0.73
73977080|NCT02000752|147500770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|||<|0.001|ONE_SIDED|95.0|7.59||||t-test, 1 sided||||||7.59|<0.001
73977081|NCT02000752|147500771|SUPERIORITY_OR_OTHER||difference in percentage|0.0||||1|TWO_SIDED|95.0|||||t-test, 2 sided|||||||1
73977082|NCT02000752|147500772|SUPERIORITY_OR_OTHER||difference in percentages|2.13||||0.16|ONE_SIDED|95.0|1.01||||t-test, 1 sided||||||1.01|0.16
73948327|NCT01118455|147429745|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
73948328|NCT01118455|147429746|SUPERIORITY_OR_OTHER|||||||0.448||95.0|||||t-test, 2 sided|||||||0.448
73948329|NCT01118455|147429746|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||t-test, 2 sided|||||||0.025
73948330|NCT01118455|147429746|SUPERIORITY_OR_OTHER|||||||0.799|||||||t-test, 2 sided|||||||0.799
73948331|NCT01118455|147429746|SUPERIORITY_OR_OTHER|||||||0.142|||||||t-test, 2 sided|||||||0.142
73977083|NCT02000752|147500773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84||||0.2|ONE_SIDED|95.0|0.84||||t-test, 2 sided||||||0.84|0.2
73977084|NCT04938453|147500779|OTHER||Ratio of GLSMs (%)|98.47|STANDARD_ERROR_OF_MEAN|13.9|||TWO_SIDED|90.0|90.87|106.69|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.69|90.87|
73977085|NCT04938453|147500780|OTHER||Ratio of GLSMs (%)|100.29|STANDARD_ERROR_OF_MEAN|29.2|||TWO_SIDED|90.0|85.05|118.24|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||118.24|85.05|
73977086|NCT04938453|147500781|OTHER||Ratio of GLSMs (%)|98.92|STANDARD_ERROR_OF_MEAN|13.8|||TWO_SIDED|90.0|91.35|107.12|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||107.12|91.35|
73977087|NCT02095145|147500786|OTHER|||||||0.19|||||||Wilcoxon rank-sum test|||||||0.190
74032170|NCT02749721|147617314|OTHER||Pearson's R|0.067||||0.819|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-28 baseline to endpoint percentage change||||0.819
73948332|NCT01118455|147429747|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||t-test, 2 sided|||||||0.714
73948333|NCT01118455|147429747|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||t-test, 2 sided|||||||0.426
73948334|NCT01118455|147429747|SUPERIORITY_OR_OTHER|||||||0.467|||||||t-test, 2 sided|||||||0.467
73948335|NCT01118455|147429747|SUPERIORITY_OR_OTHER|||||||0.654|||||||t-test, 2 sided|||||||0.654
73948336|NCT01118455|147429748|SUPERIORITY_OR_OTHER|||||||0.691|||||||ANOVA|||||||0.691
73948337|NCT01118455|147429748|SUPERIORITY_OR_OTHER|||||||0.494|||||||ANOVA|||||||0.494
74032171|NCT02749721|147617314|OTHER||Pearson's R|0.321||||0.4|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-28 baseline to endpoint percentage change||||0.400
73948338|NCT01118455|147429748|SUPERIORITY_OR_OTHER|||||||0.343|||||||ANOVA|||||||0.343
73948339|NCT01118455|147429748|SUPERIORITY_OR_OTHER|||||||0.295|||||||ANOVA|||||||0.295
73948340|NCT01200030|147429759|OTHER|The effect size of the intervention was adopted from a mate-analysis . The showed an average effect size of 0.59 in improving the motor control of limbs in people with stroke. A sample size for each group was set at 11 . Presuming that there would be a drop-out rate of 10% during the course of study, an extra 1 subject was recruited in each group. the sample size was 36. The statistical significance was set at 5% (alpha \< 0.05) with power equal to 80%|||||<|0.001||||||Post-hoc pairwise comparisons have been conducted. Please refer to subsequent data analyses.|Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in Trunk Impairment Scale (TIS) score among the three groups.||||<0.001
73948341|NCT01200030|147429759|OTHER|||||||1||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and placebo stimulation with exercises group. Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups.||||1.00
73948342|NCT01200030|147429759|OTHER|||||||0.002||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."||||0.002
73948343|NCT01200030|147429759|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of placebo stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."||||0.003
73948344|NCT01200030|147429760|OTHER|||||||0.055|||||||Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in reaching distance between the three groups.||||0.055
73948345|NCT02632786|147429761|SUPERIORITY||Risk Ratio (RR)|0.82||||0.319|TWO_SIDED|95.0|0.55|1.21|||Cochran-Mantel-Haenszel|||||1.21|0.55|0.3190
73948346|NCT02632786|147429762|SUPERIORITY||Mean Difference (Net)|-0.78||||0.5563|TWO_SIDED|95.0|-3.37|1.81|||Mixed Models Analysis|||||1.81|-3.37|0.5563
73948347|NCT02632786|147429763|SUPERIORITY||Mean Difference (Net)|5.0||||0.8992|TWO_SIDED|95.0|-11.5|23.0|||ANCOVA|||||23.00|-11.50|0.8992
73977088|NCT02095145|147500786|OTHER|||||||0.211|||||||t-test, 2 sided|||||||0.211
73977089|NCT02095145|147500789|OTHER|||||||0.948|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value||||0.948
73977090|NCT02095145|147500789|OTHER|||||||0.711|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value||||0.711
73948348|NCT02632786|147429764|SUPERIORITY||Risk Ratio (RR)|1.54||||0.3529|TWO_SIDED|95.0|0.6|3.94|||Cochran-Mantel-Haenszel|||||3.94|0.60|0.3529
73948349|NCT02632786|147429765|SUPERIORITY||Mean Difference (Net)|-0.6||||0.757|TWO_SIDED|95.0|-4.2|3.0|||Mixed Models Analysis|||||3.0|-4.2|0.7570
73948350|NCT02632786|147429766|SUPERIORITY||Slope|-71.97||||0.0729|TWO_SIDED|95.0|-150.72|6.79|||Mixed Models Analysis|||||6.79|-150.72|0.0729
73948351|NCT02632786|147429767|SUPERIORITY|||||||0.4142|||||||Cochran-Mantel-Haenszel|||||||0.4142
73948352|NCT01928225|147429768|SUPERIORITY||Risk Ratio (RR)|1.18||||0.29|TWO_SIDED|95.0|0.87|1.6||\<0.05 was considered statistically significant.|Chi-squared|||||1.6|.87|.29
73977091|NCT02095145|147500789|OTHER|||||||0.038|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value||||0.038
73977092|NCT02095145|147500789|OTHER|||||||0.445|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value||||0.445
73977093|NCT02095145|147500790|OTHER|||||||0.743|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value||||0.743
73977094|NCT02095145|147500790|OTHER|||||||0.305|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value||||0.305
74032172|NCT02749721|147617314|OTHER||Pearson's R|0.279||||0.278|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-28 baseline to endpoint percentage change||||0.278
73948353|NCT01928225|147429769|SUPERIORITY||Risk Ratio (RR)|1.26||||0.22|TWO_SIDED|95.0|0.85|1.95|||Chi-squared|||||1.95|.85|.22
73948354|NCT02265224|147429770|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|89.81||||0.0136|TWO_SIDED|94.12|82.82|97.4||p value for treatment effect|ANOVA|||||97.40|82.82|0.0136
73948355|NCT02265224|147429771|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|90.79||||0.0047|TWO_SIDED|94.12|85.25|96.69|||ANOVA|p value for treatment effect||||96.69|85.25|0.0047
73948356|NCT02265224|147429772|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|91.86||||0.0095|TWO_SIDED|94.12|86.45|97.61||p value for treatment effect|ANOVA|||||97.61|86.45|0.0095
73948357|NCT02265224|147429773|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.||||||0.505|||||||Friedman test|||||||0.5050
73948358|NCT01454830|147429794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.44||0.2|TWO_SIDED||||||t-test, 2 sided||unit of measurement, hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.20
73948359|NCT01454830|147429795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.48||0.9|TWO_SIDED||||||t-test, 2 sided||unit of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.90
73948360|NCT01454830|147429796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.53||0.89|TWO_SIDED||||||t-test, 2 sided||units of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.89
73977095|NCT02095145|147500790|OTHER|||||||0.111|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value||||0.111
74032173|NCT02749721|147617314|OTHER||Pearson's R|-0.136||||0.614|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-28 baseline to endpoint percentage change||||0.614
73977096|NCT02095145|147500790|OTHER|||||||0.395|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value||||0.395
73977097|NCT02095145|147500791|OTHER|||||||0.743|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 13||||0.743
73977098|NCT02095145|147500791|OTHER|||||||0.527|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 26||||0.527
73977099|NCT02095145|147500791|OTHER|||||||0.879|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 39||||0.879
73977100|NCT02095145|147500791|OTHER|||||||0.81|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 52||||0.810
73977101|NCT02095145|147500792|OTHER|||||||0.556|||||||Wilcoxon rank-sum test|||Comparison of both arms at baseline||||0.556
73977102|NCT02095145|147500792|OTHER|||||||0.647|||||||Wilcoxon rank-sum test|||comparison of both arms at Week 26||||0.647
73977103|NCT02095145|147500792|OTHER|||||||0.948|||||||Wilcoxon rank-sum test|||comparison of both arms at end of study, week 52||||0.948
73977104|NCT02095145|147500793|OTHER|||||||0.58|||||||Wilcoxon rank-sum test|||||||0.580
73977105|NCT02095145|147500794|OTHER|||||||0.344|||||||Wilcoxon rank-sum test|||Benign core p-value||||0.344
73977106|NCT02095145|147500794|OTHER|||||||0.371|||||||Wilcoxon rank-sum test|||Adjacent core p-value||||0.371
73977107|NCT02095145|147500794|OTHER|||||||0.766|||||||Wilcoxon rank-sum test|||Tumor core p-value||||0.766
74032174|NCT02749721|147617314|OTHER||Pearson's R|0.0||||0.999|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-17 baseline scores||||0.999
73948361|NCT01454830|147429797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|4.09||0.78|TWO_SIDED||||||t-test, 2 sided||units of measurement: % TST; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Exploratory outcome of PAP use defined within the sleep period, TST (total sleep time).||||0.78
73948362|NCT00136812|147429829|OTHER|We used all available observations in a GEE analysis and did not impute missing data or drop observations.|Odds Ratio (OR)|3.15||||0.018|TWO_SIDED|95.0|1.22|8.14||P-value of \<0.05 is considered statistically significant.|generalized estimating equation model|||To test the primary hypothesis, we ran a generalized estimating equation model with logit link function (PROC GENMOD in SAS version 9.2), to examine abstinence versus smoking status at the 3- through 18-month follow-ups by condition.||8.14|1.22|0.018
73948363|NCT00569803|147429832|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.86|||||TWO_SIDED|90.0|0.68|1.08|||||Ratio of Geometric Means: 50mg SC over 125mg IV|||1.08|0.68|
73948364|NCT00569803|147429832|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.61|||||TWO_SIDED|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV|||0.77|0.48|
73948365|NCT00569803|147429832|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.78|||||TWO_SIDED|90.0|0.62|0.99|||||Ratio of Geometric Means: 125mg SC over 125mg IV|||0.99|0.62|
73948366|NCT00569803|147429832|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.89|||||TWO_SIDED|90.0|0.71|1.13|||||Ratio of Geometric Means: 150mg SC over 125mg IV|||1.13|0.71|
73977108|NCT02095145|147500795|OTHER|||||||0.304|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Nuc)||||0.304
73977109|NCT02095145|147500795|OTHER|||||||0.23|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Nuc)||||0.230
73948367|NCT00569803|147429832|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.88|||||TWO_SIDED|90.0|0.69|1.11|||||Ratio of Geometric Means: 200mg SC over 125mg IV|||1.11|0.69|
73948368|NCT00569803|147429832|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.73|||||TWO_SIDED|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV|||0.92|0.57|
73948369|NCT00569803|147429833|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.87|||||TWO_SIDED|90.0|0.69|1.1|||||Ratio of Geometric Means: 50mg SC over 125mg IV|||1.10|0.69|
73948370|NCT00569803|147429833|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.61|||||TWO_SIDED|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV|||0.77|0.48|
73977110|NCT02095145|147500795|OTHER|||||||0.298|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Nuc)||||0.298
73977111|NCT02095145|147500795|OTHER|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cyt)||||0.247
73948371|NCT00569803|147429833|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.79|||||TWO_SIDED|90.0|0.62|1.0|||||Ratio of Geometric Means: 125mg SC over 125mg IV|||1.00|0.62|
73948372|NCT00569803|147429833|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.71|1.14|||||Ratio of Geometric Means: 150mg SC over 125mg IV|||1.14|0.71|
73948373|NCT00569803|147429833|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.88|||||TWO_SIDED|90.0|0.69|1.12|||||Ratio of Geometric Means: 200mg SC over 125mg IV|||1.12|0.69|
73977112|NCT02095145|147500795|OTHER|||||||0.093|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cyt)||||0.093
73977113|NCT02095145|147500795|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cyt)||||0.066
73977114|NCT02095145|147500795|OTHER|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cell)||||0.247
73977115|NCT02095145|147500795|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cell)||||0.128
73977116|NCT02095145|147500795|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cell)||||0.128
73977117|NCT02095145|147500796|OTHER|||||||0.297|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.297
73977118|NCT02095145|147500796|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.233
73977119|NCT02095145|147500796|OTHER|||||||0.371|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.371
73977120|NCT02095145|147500796|OTHER|||||||0.198|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.198
73948374|NCT00569803|147429833|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.73|||||TWO_SIDED|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV|||0.92|0.57|
73948375|NCT00569803|147429839|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.75|1.07|||||AUC(0-T) Ratio of Geometric Means: 1 injection site over 2 injection sites|||1.07|0.75|
73948376|NCT00569803|147429839|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.75|1.07|||||AUC(INF) Ratio of Geometric Means: 1 injection site over 2 injection sites|||1.07|0.75|
73948377|NCT02006420|147429865|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin thickness of the forearm.||||0.005
73948378|NCT02006420|147429865|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin stiffness of the thigh||||0.71
73948379|NCT02006420|147429866|SUPERIORITY|||||||0.002|||||||Pearson correlation|||This is the p-value for the forearm||||0.002
73948380|NCT02006420|147429866|SUPERIORITY|||||||0.007|||||||Pearson correlation|||This is the p-value for the thigh||||0.007
73948381|NCT02006420|147429867|SUPERIORITY|||||||0.002|||||||Pearson correlation|||This is the p value for the forearm.||||0.002
73948382|NCT02006420|147429867|SUPERIORITY|||||||0.007|||||||Pearson correlation|||This is the p value for the thigh||||0.007
73948383|NCT02006420|147429869|SUPERIORITY||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the forearm||||<.0001
73948384|NCT02006420|147429869|SUPERIORITY||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the thigh||||<0.0001
73948385|NCT02006420|147429871|SUPERIORITY|||||||0.01|||||||Pearson correlation|||This is the p-value for the forearm||||0.01
73948386|NCT02006420|147429871|SUPERIORITY|||||||0.1|||||||Pearson correlation|||This is the p-value for the thigh||||0.10
73948387|NCT00791921|147429872|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Regression, Logistic|||For ACR20 responder rate at Week 12, comparison between the CDP870 200 mg group and the placebo group was performed.||||<0.05
73977121|NCT02095145|147500796|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.233
73977122|NCT02095145|147500796|OTHER|||||||0.074|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.074
73977123|NCT02095145|147500796|OTHER|||||||0.234|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.234
73977124|NCT02095145|147500796|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.233
73870544|NCT03350815|147284767|OTHER|Statistical hypothesis tests were not performed for this study|Least Square Mean of Treatment Differenc|0.23|STANDARD_ERROR_OF_MEAN|0.263|||TWO_SIDED|95.0|-0.29|0.75||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Mixed Models Analysis|||Statistical analysis of total BASDAI change from Week 16 using MMRM - in Treatment Period 2 (FAS)||0.75|-0.29|
73870545|NCT03350815|147284768|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.5|3.24||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of BASDAI50 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||3.24|0.50|
73870546|NCT03350815|147284769|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.43|1.73||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables|Regression, Logistic|||Statistical analysis (logistic regression) of BASDAI20 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||1.73|0.43|
73870547|NCT03350815|147284770|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.49|3.46||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of ASAS40 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||3.46|0.49|
73948388|NCT00791921|147429873|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Regression, Logistic|||||||<0.05
73948389|NCT00474175|147429875|SUPERIORITY_OR_OTHER||Treatment difference|16.46|||<|0.001|TWO_SIDED|95.0|7.2|25.7||Alternative hypotheses tested in the study was that benzocaine 20% was significantly (p less than or equal to \[=\<\] 0.05) more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and its associated confidence interval (C.I.) was calculated based on CMH weighted percentages and the corresponding standard error.||25.7|7.2|<0.001
73948390|NCT00474175|147429875|SUPERIORITY_OR_OTHER||Treatment difference|9.8||||0.038|TWO_SIDED|95.0|0.3|19.3||Alternative hypotheses tested in the study was that benzocaine 10% was significantly (p=\<0.05) more effective than placebo provided that benzocaine 20% was more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.||19.3|0.3|0.038
73948391|NCT00474175|147429875|SUPERIORITY_OR_OTHER||Treatment difference|6.72||||0.047|TWO_SIDED|95.0|0.2|13.3|||Cochran-Mantel-Haenszel|Dose response was considered established if the percentage of responders between the 20% and 10% was greater than or equal to 5%.||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.||13.3|0.2|0.047
73977125|NCT02095145|147500796|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.233
73977126|NCT02095145|147500797|OTHER|||||||0.167|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.167
73977127|NCT02095145|147500797|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.391
73977128|NCT02095145|147500797|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.713
73977129|NCT02095145|147500797|OTHER|||||||0.452|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.452
73977130|NCT02095145|147500797|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.391
73977131|NCT02095145|147500797|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.713
73977132|NCT02095145|147500797|OTHER|||||||0.344|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.344
73977133|NCT02095145|147500797|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.391
74032175|NCT02749721|147617314|OTHER||Pearson's R|0.193||||0.491|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-17 baseline scores||||0.491
74032176|NCT02749721|147617314|OTHER||Pearson's R|0.567||||0.028|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-17 baseline scores||||0.028
73870548|NCT03350815|147284771|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.44|2.41||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status(naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of ASAS partial remission response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||2.41|0.44|
73870549|NCT03350815|147284772|OTHER|Statistical hypothesis tests were not performed for this study|Mean Difference (Final Values)|0.13|||||TWO_SIDED|95.0|-0.74|1.01||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Regression, Logistic|||Statistical analysis of change from Week 16 in ASAS-Health Index using MMRM by visit - in Treatment Period 2 (FAS)||1.01|-0.74|
73870550|NCT03350815|147284773|OTHER|Statistical hypothesis tests were not performed for this study|Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.62|1.61||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Regression, Logistic|||||1.61|-3.62|
73870551|NCT03906071|147284801|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.144|TWO_SIDED|95.0|0.7|1.05||The p-value is based on a unstratified log-rank test. (2-Sided)|Log Rank||Based on the unstratified cox proportional hazards model.|||1.05|0.70|0.144
73977134|NCT02095145|147500797|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.713
73977135|NCT02095145|147500798|OTHER|||||||0.865|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value||||0.865
73977136|NCT02095145|147500798|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value||||1.000
73977137|NCT02095145|147500798|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value||||0.066
73977138|NCT02095145|147500799|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Benign p-value||||1.000
73977139|NCT02095145|147500799|OTHER|||||||0.903|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Adjacent p-value||||0.903
73977140|NCT02095145|147500799|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Tumor p-value||||1.000
73977141|NCT02095145|147500799|OTHER|||||||0.269|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Benign p-value||||0.269
73977142|NCT02095145|147500799|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Adjacent p-value||||0.066
73977143|NCT02095145|147500799|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Tumor p-value||||1.000
73977144|NCT02095145|147500799|OTHER|||||||0.425|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Benign p-value||||0.425
73977145|NCT02095145|147500799|OTHER|||||||0.27|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Adjacent p-value||||0.270
73977146|NCT02095145|147500799|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Tumor p-value||||1.000
73977147|NCT02095145|147500800|OTHER|||||||0.625|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.625
74032177|NCT02749721|147617314|OTHER||Pearson's R|-0.03||||0.9|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-17 baseline scores||||0.900
74032178|NCT02749721|147617314|OTHER||Pearson's R|0.141||||0.55|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-17 baseline scores||||0.55
74032179|NCT02749721|147617314|OTHER||Pearson's R|0.231||||0.373|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-17 baseline to endpoint percent change||||0.373
74032180|NCT02749721|147617314|OTHER||Pearson's R|0.019||||0.949|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-17 baseline to endpoint percent change||||0.949
74032181|NCT02749721|147617314|OTHER||Pearson's R|0.122||||0.754|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-17 baseline to endpoint percent change||||0.754
74032182|NCT02749721|147617314|OTHER||Pearson's R|0.176||||0.499|TWO_SIDED||||||0.176|||Correlation between VGNG P200 (latency) and HDRS-17 baseline to endpoint percent change||||0.499
74032183|NCT02749721|147617314|OTHER||Pearson's R|-0.162||||0.549|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-17 baseline to endpoint percent change||||0.549
74032184|NCT02749721|147617314|OTHER||Pearson's R|-0.126||||0.617|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and QIDS-SR baseline scores||||0.617
73977148|NCT02095145|147500800|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.128
73977149|NCT02095145|147500800|OTHER|||||||0.045|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.045
73977150|NCT02095145|147500800|OTHER|||||||0.105|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.105
73977151|NCT02095145|147500800|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.066
73977152|NCT02095145|147500800|OTHER|||||||0.005|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.005
73977153|NCT02095145|147500800|OTHER|||||||0.129|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.129
73977154|NCT02095145|147500800|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.066
73977155|NCT02095145|147500800|OTHER|||||||0.013|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.013
73977156|NCT02095145|147500801|OTHER|||||||0.143|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value||||0.143
73977157|NCT02095145|147500801|OTHER|||||||0.037|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value||||0.037
73977158|NCT02095145|147500801|OTHER|||||||0.111|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value||||0.111
73977159|NCT02095145|147500802|OTHER|||||||0.068|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13||||0.068
73977160|NCT02095145|147500802|OTHER|||||||0.004|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26||||0.004
73977161|NCT02095145|147500802|OTHER|||||||0.002|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39||||0.002
73977162|NCT02095145|147500802|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52||||<0.001
73977163|NCT02095145|147500803|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13||||1.000
73977164|NCT02095145|147500803|OTHER|||||||0.18|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26||||0.180
73977165|NCT02095145|147500803|OTHER|||||||0.62|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39||||0.620
73977166|NCT02095145|147500803|OTHER|||||||0.536|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52||||0.536
73977167|NCT02095145|147500805|OTHER|||||||0.231|||||||Wilcoxon rank-sum test|||Change in Tumor Volume from baseline to end of study per arm||||0.231
73977168|NCT04237792|147500812|OTHER||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.03|0.29|||Cochran-Mantel-Haenszel|||||0.29|0.03|<0.001
73977169|NCT04237792|147500813|OTHER||Odds Ratio (OR)|0.18||||0.022|TWO_SIDED|95.0|0.04|0.82|||Mantel Haenszel|||||0.82|0.04|0.022
73977170|NCT04237792|147500813|OTHER||Odds Ratio (OR)|0.05|||<|0.001|TWO_SIDED|95.0|0.01|0.26|||Mantel Haenszel|||||0.26|0.01|<0.001
73977171|NCT04237792|147500814|OTHER||Odds Ratio (OR)|0.11||||0.006|TWO_SIDED|95.0|0.02|0.59|||Mantel Haenszel|||||0.59|0.02|0.006
73977172|NCT04237792|147500814|OTHER||Odds Ratio (OR)|1.68||||0.597|TWO_SIDED|95.0|0.25|11.27|||Mantel Haenszel|||||11.27|0.25|0.597
73977173|NCT04237792|147500814|OTHER||Odds Ratio (OR)|0.54||||0.374|TWO_SIDED|95.0|0.14|2.07|||Mantel Haenszel|||||2.07|0.14|0.374
73977174|NCT04237792|147500814|OTHER||Odds Ratio (OR)|0.1||||0.001|TWO_SIDED|95.0|0.02|0.44|||Mantel Haenszel|||||0.44|0.02|0.001
74032185|NCT02749721|147617314|OTHER||Pearson's R|0.1||||0.722|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and QIDS-SR baseline scores||||0.722
74032186|NCT02749721|147617314|OTHER||Pearson's R|0.249||||0.371|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and QIDS-SR baseline scores||||0.371
73948392|NCT00474175|147429876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.02|||<|0.001|TWO_SIDED|95.0|1.55|2.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. Hazard Ratio (HR) of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.64|1.55|<0.001
73948393|NCT00474175|147429876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.63|||<|0.001|TWO_SIDED|95.0|1.26|2.12||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.12|1.26|<0.001
73948394|NCT00474175|147429876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.03|TWO_SIDED|95.0|1.02|1.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.||1.51|1.02|0.030
73948395|NCT00474175|147429877|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.04|||<|0.001|TWO_SIDED|95.0|1.57|2.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.66|1.57|<0.001
73948396|NCT00474175|147429877|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73|||<|0.001|TWO_SIDED|95.0|1.34|2.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.25|1.34|<0.001
73948397|NCT00474175|147429877|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.1|TWO_SIDED|95.0|0.97|1.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.||1.43|0.97|0.100
73948398|NCT00474175|147429879|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.035|TWO_SIDED|95.0|0.03|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using Analysis of Variance (ANOVA) which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.95|0.03|0.035
73948399|NCT00474175|147429879|SUPERIORITY_OR_OTHER||Treatment difference|0.32||||0.173|TWO_SIDED|95.0|-0.14|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.78|-0.14|0.173
73977175|NCT04237792|147500814|OTHER||Odds Ratio (OR)|0.32||||0.015|TWO_SIDED|95.0|0.13|0.81|||Mantel Haenszel|||||0.81|0.13|0.015
74032187|NCT02749721|147617314|OTHER||Pearson's R|-0.072||||0.764|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and QIDS-SR baseline scores||||0.764
74032188|NCT02749721|147617314|OTHER||Pearson's R|-0.225||||0.34|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and QIDS-SR baseline scores||||0.34
74032189|NCT02749721|147617314|OTHER||Pearson's R|0.148||||0.57|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and QIDS-SR baseline to endpoint percent change||||0.570
73948400|NCT00474175|147429879|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.358|TWO_SIDED|95.0|-0.2|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.20|0.358
73948401|NCT00474175|147429879|SUPERIORITY_OR_OTHER||Treatment difference|0.75||||0.135|TWO_SIDED|95.0|-0.23|1.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.72|-0.23|0.135
73948402|NCT00474175|147429879|SUPERIORITY_OR_OTHER||Treatment difference|0.48||||0.332|TWO_SIDED|95.0|-0.49|1.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.46|-0.49|0.332
73948403|NCT00474175|147429879|SUPERIORITY_OR_OTHER||Treatment difference|0.26||||0.517|TWO_SIDED|95.0|-0.53|1.06||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.06|-0.53|0.517
73977176|NCT04237792|147500814|OTHER||Odds Ratio (OR)|0.3||||0.024|TWO_SIDED|95.0|0.1|0.87|||Mantel Haenszel|||||0.87|0.10|0.024
73977177|NCT04237792|147500815|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
73977178|NCT04237792|147500815|OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
73977179|NCT04237792|147500815|OTHER|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
73977180|NCT04237792|147500815|OTHER|||||||0.213|||||||Wilcoxon (Mann-Whitney)|||||||0.213
73948404|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.35||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.35|0.50|<0.001
73948405|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.55||||0.011|TWO_SIDED|95.0|0.13|0.97||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.97|0.13|0.011
73948406|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.38||||0.031|TWO_SIDED|95.0|0.03|0.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.72|0.03|0.031
73948407|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.78|||<|0.001|TWO_SIDED|95.0|0.33|1.23||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.23|0.33|<0.001
73948408|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.031|TWO_SIDED|95.0|0.04|0.94||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.94|0.04|0.031
73948409|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.29||||0.119|TWO_SIDED|95.0|-0.07|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.66|-0.07|0.119
73977181|NCT04237792|147500815|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73977182|NCT04237792|147500815|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
73977183|NCT04237792|147500815|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
73977184|NCT04237792|147500815|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74032190|NCT02749721|147617314|OTHER||Pearson's R|0.228||||0.434|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and QIDS-SR baseline to endpoint percent change||||0.434
73948410|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.77||||0.002|TWO_SIDED|95.0|0.28|1.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.25|0.28|0.002
73948411|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.46||||0.061|TWO_SIDED|95.0|-0.02|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.95|-0.02|0.061
73977185|NCT04237792|147500815|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73977186|NCT04237792|147500816|OTHER|||||||0.016|||||||Log Rank|||||||0.016
73977187|NCT04237792|147500816|OTHER|||||||0.005|||||||Log Rank|||||||0.005
73977188|NCT04237792|147500816|OTHER|||||||0.368|||||||Log Rank|||||||0.368
73977189|NCT04237792|147500816|OTHER|||||||0.358|||||||Log Rank|||||||0.358
73977190|NCT04237792|147500816|OTHER|||||||0|||||||Log Rank|||||||0.000
73977191|NCT04237792|147500816|OTHER|||||||0.001|||||||Log Rank|||||||0.001
73977192|NCT04237792|147500816|OTHER|||||||0.02|||||||Log Rank|||||||0.020
73977193|NCT04237792|147500816|OTHER|||||||0|||||||Log Rank|||||||0.000
73977194|NCT04237792|147500816|OTHER|||||||0.005|||||||Log Rank|||||||0.005
73977195|NCT04237792|147500817|OTHER|||||||0.884|||||||Log Rank|||||||0.884
73977196|NCT04237792|147500817|OTHER|||||||0.662|||||||Log Rank|||||||0.662
73977197|NCT04237792|147500817|OTHER|||||||0.236|||||||Log Rank|||||||0.236
73977198|NCT04237792|147500817|OTHER|||||||0.733|||||||Log Rank|||||||0.733
73977199|NCT04237792|147500817|OTHER|||||||0.128|||||||Log Rank|||||||0.128
73977200|NCT04237792|147500817|OTHER|||||||0.165|||||||Log Rank|||||||0.165
73977201|NCT04237792|147500817|OTHER|||||||0.752|||||||Log Rank|||||||0.752
73977202|NCT04237792|147500817|OTHER|||||||0.139|||||||Log Rank|||||||0.139
73977203|NCT04237792|147500817|OTHER|||||||0.051|||||||Log Rank|||||||0.051
73977204|NCT04237792|147500819|OTHER|||||||0.124|||||||ANOVA|||||||0.124
73977205|NCT04237792|147500819|OTHER|||||||0.186|||||||ANOVA|||||||0.186
73977206|NCT04237792|147500819|OTHER|||||||0.47|||||||ANOVA|||||||0.470
73977207|NCT04237792|147500819|OTHER|||||||0.845|||||||ANOVA|||||||0.845
73977208|NCT04237792|147500819|OTHER|||||||0.621|||||||ANOVA|||||||0.621
73977209|NCT04237792|147500819|OTHER|||||||0.747|||||||ANOVA|||||||0.747
73977210|NCT04237792|147500819|OTHER|||||||0.218|||||||ANOVA|||||||0.218
73977211|NCT04237792|147500819|OTHER|||||||0.181|||||||ANOVA|||||||0.181
73977212|NCT04237792|147500819|OTHER|||||||0.984|||||||ANOVA|||||||0.984
73977213|NCT04237792|147500820|OTHER|||||||0.048|||||||ANOVA|||||||0.048
73977214|NCT04237792|147500820|OTHER|||||||0.106|||||||ANOVA|||||||0.106
73977215|NCT04237792|147500820|OTHER|||||||0.196|||||||ANOVA|||||||0.196
73870552|NCT01979952|147284844|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.176|STANDARD_ERROR_OF_MEAN|6.237|||TWO_SIDED|95.0|-9.227|15.579|||ANCOVA|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate||15.579|-9.227|
73948412|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.3||||0.131|TWO_SIDED|95.0|-0.09|0.7||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.70|-0.09|0.131
73948413|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.52||||0.044|TWO_SIDED|95.0|0.01|1.03||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.03|0.01|0.044
73948414|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.43||||0.099|TWO_SIDED|95.0|-0.08|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.93|-0.08|0.099
73948415|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.1||||0.647|TWO_SIDED|95.0|-0.32|0.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.51|-0.32|0.647
73948416|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.6||||0.023|TWO_SIDED|95.0|0.08|1.11||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.11|0.08|0.023
73948417|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.47||||0.072|TWO_SIDED|95.0|-0.04|0.98||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.98|-0.04|0.072
73948418|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.13||||0.551|TWO_SIDED|95.0|-0.29|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.29|0.551
73870553|NCT01979952|147284845|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.519|STANDARD_ERROR_OF_MEAN|6.3829|||TWO_SIDED|95.0|-10.258|15.296|||ANCOVA|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate||15.296|-10.258|
73948419|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.54||||0.047|TWO_SIDED|95.0|0.01|1.08||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.08|0.01|0.047
73948420|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.27||||0.316|TWO_SIDED|95.0|-0.26|0.81||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.81|-0.26|0.316
73948421|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.27||||0.224|TWO_SIDED|95.0|-0.17|0.71||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.71|-0.17|0.224
73948422|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.46||||0.099|TWO_SIDED|95.0|-0.09|1.01||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.01|-0.09|0.099
73977216|NCT04237792|147500820|OTHER|||||||0.94|||||||ANOVA|||||||0.940
73977217|NCT04237792|147500820|OTHER|||||||0.824|||||||ANOVA|||||||0.824
73977218|NCT04237792|147500820|OTHER|||||||0.678|||||||ANOVA|||||||0.678
73977219|NCT04237792|147500820|OTHER|||||||0.129|||||||ANOVA|||||||0.129
73977220|NCT04237792|147500820|OTHER|||||||0.16|||||||ANOVA|||||||0.160
73977221|NCT04237792|147500820|OTHER|||||||0.872|||||||ANOVA|||||||0.872
73977222|NCT05553366|147500826|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
73977223|NCT05553366|147500827|SUPERIORITY|||||||0.0016|||||||ANCOVA|||||||0.0016
73977224|NCT05553366|147500828|SUPERIORITY|||||||0.0016|||||||Log Rank|||||||0.0016
73977225|NCT05553366|147500829|SUPERIORITY|||||||0.1315|||||||Log Rank|||||||0.1315
73948423|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.37||||0.186|TWO_SIDED|95.0|-0.18|0.92||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.92|-0.18|0.186
73948424|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.09||||0.684|TWO_SIDED|95.0|-0.35|0.54||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.54|-0.35|0.684
73948425|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.452|TWO_SIDED|95.0|-0.34|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.76|-0.34|0.452
73948426|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.2||||0.479|TWO_SIDED|95.0|-0.35|0.75||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.75|-0.35|0.479
73948427|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.01||||0.955|TWO_SIDED|95.0|-0.44|0.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.46|-0.44|0.955
73948428|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.465|TWO_SIDED|95.0|-0.36|0.79||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.79|-0.36|0.465
73948429|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.992|TWO_SIDED|95.0|-0.57|0.58||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.58|-0.57|0.992
73948430|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.376|TWO_SIDED|95.0|-0.26|0.68||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.68|-0.26|0.376
73948431|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.36||||0.229|TWO_SIDED|95.0|-0.22|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.93|-0.22|0.229
73948432|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.16||||0.581|TWO_SIDED|95.0|-0.41|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.74|-0.41|0.581
73948433|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.19||||0.422|TWO_SIDED|95.0|-0.28|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.66|-0.28|0.422
73948434|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.33||||0.271|TWO_SIDED|95.0|-0.26|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.91|-0.26|0.271
73948435|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.15||||0.612|TWO_SIDED|95.0|-0.43|0.73||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.73|-0.43|0.612
73977226|NCT05553366|147500830|SUPERIORITY|||||||0.0343|||||||Cochran-Mantel-Haenszel|||||||0.0343
73977227|NCT05553366|147500831|SUPERIORITY|||||||0.0014|||||||Pearson's chi-squared test|||||||0.0014
74089282|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3486|TWO_SIDED|95.0|0.7|2.72|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|0.70|0.3486
73948436|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.465|TWO_SIDED|95.0|-0.3|0.65||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.65|-0.30|0.465
73948437|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.32||||0.29|TWO_SIDED|95.0|-0.27|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.91|-0.27|0.290
73948438|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.25||||0.412|TWO_SIDED|95.0|-0.34|0.83||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.83|-0.34|0.412
73948439|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.07||||0.769|TWO_SIDED|95.0|-0.41|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.41|0.769
73948440|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.15||||0.61|TWO_SIDED|95.0|-0.43|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.74|-0.43|0.610
73948441|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.2||||0.511|TWO_SIDED|95.0|-0.39|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.78|-0.39|0.511
73948442|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.859|TWO_SIDED|95.0|-0.52|0.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.43|-0.52|0.859
73948443|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.26||||0.386|TWO_SIDED|95.0|-0.33|0.84||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.84|-0.33|0.386
73948444|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.563|TWO_SIDED|95.0|-0.41|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.76|-0.41|0.563
73977228|NCT05553366|147500832|SUPERIORITY|||||||0.0032|||||||ANCOVA|||||||0.0032
73948445|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.09||||0.721|TWO_SIDED|95.0|-0.39|0.56||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.56|-0.39|0.721
73977229|NCT05553366|147500833|SUPERIORITY|||||||0.8592|||||||Log Rank|||||||0.8592
73977230|NCT05553366|147500834|SUPERIORITY|||||||0.9143|||||||Cochran-Mantel-Haenszel|||||||0.9143
74032191|NCT02749721|147617314|OTHER||Pearson's R|0.22||||0.569|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and QIDS-SR baseline to endpoint percent change||||0.569
73977231|NCT05553366|147500835|SUPERIORITY|||||||0.0205|||||||Wilcoxon rank-sum|||||||0.0205
73977232|NCT03739866|147500846|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73977233|NCT03739866|147500846|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73977234|NCT03739866|147500846|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73977235|NCT03739866|147500846|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73977236|NCT03739866|147500846|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73977237|NCT01034306|147500860|SUPERIORITY|||||||0.0352||||||normal approximation to the binomial test|t-test, 2 sided|||||||0.0352
73977238|NCT01034306|147500861|SUPERIORITY|||||||0.2472|||||||t-test, 2 sided|||||||.2472
73977239|NCT01034306|147500862|SUPERIORITY|||||||0.1972|||||||t-test, 2 sided|||||||0.1972
73977240|NCT01619059|147500863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.087|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||Tested at alpha=0.05|Mixed Models Analysis|||||-0.18|-0.52|<0.0001
73977241|NCT01619059|147500864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|4.576||0.2014|TWO_SIDED|95.0|-14.9|3.1||Secondary endpoints were tested at alpha=0.05, applying the hierarchical order for the sequential testing procedure|Mixed Models Analysis|||||3.1|-14.9|0.2014
74032192|NCT02749721|147617314|OTHER||Pearson's R|0.645||||0.005|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and QIDS-SR baseline to endpoint percent change||||0.005
73870554|NCT01979952|147284846|SUPERIORITY_OR_OTHER||Adjusted mean difference|69.0|STANDARD_ERROR_OF_MEAN|39.182|||TWO_SIDED|95.0|-8.74|146.75|||Mixed Models Analysis|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||Mixed Model for Repeated Measures (MMRM) model with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix.||146.75|-8.74|
73870555|NCT01979952|147284847|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.36|||||TWO_SIDED|95.0|-0.29|5.0|||Mixed Models Analysis|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||MMRM model with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix.||5.00|-0.29|
73870556|NCT01979952|147284849|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.05|STANDARD_ERROR_OF_MEAN|2.434|||TWO_SIDED|95.0|-4.89|4.79|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||4.79|-4.89|
73948446|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.1||||0.725|TWO_SIDED|95.0|-0.48|0.69||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.69|-0.48|0.725
73948447|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.06||||0.839|TWO_SIDED|95.0|-0.52|0.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.64|-0.52|0.839
73948448|NCT00474175|147429881|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.855|TWO_SIDED|95.0|-0.43|0.52||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.52|-0.43|0.855
73948449|NCT00474175|147429882|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.035|TWO_SIDED|95.0|0.01|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.33|0.01|0.035
73948450|NCT00474175|147429882|SUPERIORITY_OR_OTHER||Treatment difference|0.16||||0.039|TWO_SIDED|95.0|0.0|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 10% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.33|-0.00|0.039
73948451|NCT00474175|147429882|SUPERIORITY_OR_OTHER||Treatment difference|-0.01||||0.944|TWO_SIDED|95.0|-0.15|0.13||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Benzocaine 10%) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.13|-0.15|0.944
74089283|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0002|TWO_SIDED|95.0|1.42|3.02|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|1.42|0.0002
73948452|NCT04542226|147429885|OTHER||||||<|1e-07||||||the a priori threshold for statistical significance p\<0.05|Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test for repeated measures was used to compare with baseline.||||||<0.0000001
73948453|NCT01460160|147429894|SUPERIORITY||Estimate of Difference|16.86||||0.032|TWO_SIDED|90.0|3.9|29.8||Superiority test versus AIEOP-BFM 2000|Chi-squared||Treatment difference (CA180372 - AIEOP-BFM 2000)|Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in AIEOP-BFM 2000 historical control||29.8|3.9|0.032
73977242|NCT01619059|147500865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|3.713|||TWO_SIDED|95.0|-11.0|3.6||||||||3.6|-11.0|
73870557|NCT01979952|147284850|SUPERIORITY_OR_OTHER||Adjusted mean difference|17.94|STANDARD_ERROR_OF_MEAN|16.19|||TWO_SIDED|95.0|-14.21|50.09|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||50.09|-14.21|
73977243|NCT01619059|147500866|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|4.504|||TWO_SIDED|95.0|3.4|21.0||||||||21.0|3.4|
73870558|NCT01979952|147284851|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.89|||||TWO_SIDED|95.0|-1.47|11.25|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||11.25|-1.47|
73870559|NCT05438576|147284856|SUPERIORITY||Odds Ratio (OR)|2.12||||0.032|TWO_SIDED|95.0|1.05|4.27|||Regression, Logistic|||||4.27|1.05|0.032
73870560|NCT05438576|147284861|SUPERIORITY||Odds Ratio (OR)|1.1||||0.621|TWO_SIDED|95.0|0.74|1.64|||Regression, Logistic|||||1.64|0.74|0.621
73870561|NCT00465088|147284875|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05|Mixed Models Analysis|||An n = 81 for niacin extended-release with simvastatin and n = 54 for atorvastatin would provide \> 99% power to detect a 13% increase in HDL-C with niacin extended-release with simvastatin relative to atorvastatin, assuming an SD of 16%||||<0.001
73870562|NCT00555672|147284906|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|27.3|||||TWO_SIDED|95.0|13.3|45.5|||Fisher Exact|Exact Method based on the F Distribution.||||45.5|13.3|
73948454|NCT01460160|147429894|NON_INFERIORITY|non-inferiority margin = 5%. One-sided type I error rate of 0.05|Estimate of difference|6.91||||0.271|TWO_SIDED|90.0|-3.3|17.2||Superiority test versus EsPhALL|Chi-squared||Treatment difference (CA180372 - EsPhALL) Test if lower confidence limit is above -5%|Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control||17.2|-3.3|0.271
73948455|NCT01460160|147429894|SUPERIORITY|Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in COG AALL0031 historical control|Estimate of difference|-10.75||||0.157|TWO_SIDED|90.0|-22.7|1.2|||Chi-squared||Treatment difference (CA180372 - COG AALL0031)|||1.2|-22.7|0.157
73948456|NCT02091739|147429901|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.031|=|0.004|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square (LS) means estimates of an mixed model repeated measurement (MMRM) model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units versus (v) Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.03|-0.15|= 0.004
73948457|NCT02091739|147429901|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.542|TWO_SIDED|95.0|-0.08|0.04|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.04|-0.08|= 0.542
73948458|NCT02091739|147429902|SUPERIORITY||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|0.183|=|0.002|TWO_SIDED|95.0|0.22|0.94|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.94|0.22|= 0.002
73948459|NCT02091739|147429902|SUPERIORITY||LS mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.181|=|0.055|TWO_SIDED|95.0|-0.01|0.71|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.71|-0.01|= 0.055
73948460|NCT00192023|147429905|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change to Week 8 Endpoint. Change = Endpoint minus baseline. Model: Change to Week 8=score at Week 8+treatment+site+treatment-by-site interaction. If treatment-by-site interaction isn't significant it will be removed from model.|ANCOVA|||Using an estimate of the common standard deviation of 13 points, the planned sample size will give about 80% power to detect a difference between the groups of 8 points on the SNAP-IV. The sample size was determined using a two-sided test with p=0.05, and assumes that up to 10% of patients will discontinue the study without providing post-baseline efficacy data in Study Period III.||||<0.001
73977244|NCT01335867|147500867|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||.14
74032193|NCT02749721|147617314|OTHER||Pearson's R|0.105||||0.698|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and QIDS-SR baseline to endpoint percent change||||0.698
74032194|NCT02749721|147617314|OTHER||Pearson's R|-0.073||||0.774|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and PDQ baseline scores||||0.774
73948461|NCT00192023|147429906|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
73948462|NCT00192023|147429907|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.001
73948463|NCT00192023|147429908|SUPERIORITY_OR_OTHER|||||||0.836||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.836
73948464|NCT00192023|147429909|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.870
73948465|NCT00192023|147429910|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.002
73948466|NCT00192023|147429910|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
73948467|NCT00192023|147429910|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.022
73948468|NCT00192023|147429910|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
73948469|NCT00192023|147429911|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.071
73948470|NCT00192023|147429912|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.002
73977245|NCT01335867|147500869|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||.24
73977246|NCT01335867|147500870|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||.20
73977247|NCT01335867|147500871|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||.64
73977248|NCT03057600|147500872|SUPERIORITY|||||||0.2252|||||||exact one-sample binomial tests|||||||0.2252
73977249|NCT03057600|147500872|SUPERIORITY|||||||0.9437|||||||exact one-sample binomial tests|||||||0.9437
73977250|NCT03057600|147500872|SUPERIORITY|||||||0.5797|||||||exact one-sample binomial tests|||||||0.5797
74032195|NCT02749721|147617314|OTHER||Pearson's R|0.577||||0.024|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and PDQ baseline score||||0.024
74032196|NCT02749721|147617314|OTHER||Pearson's R|0.146||||0.603|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and PDQ baseline scores||||0.603
73948471|NCT00192023|147429912|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.113
73948472|NCT00192023|147429912|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.051
73948473|NCT00192023|147429912|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.061
73948474|NCT00308737|147429922|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of TI + Usual Care to Usual Care only|Mean Difference (Final Values)|0.037|||||TWO_SIDED|95.0|0.014|0.06|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FEV1 as a covariate||0.060|0.014|
73948475|NCT00308737|147429923|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis tested was that the FEV1 change from Baseline for the TI group is no greater than 50 mL/year above the change in the usual care treatment group. Assuming SD of 100 mL/y, 80% power, and 5% (1-tailed) significance level, it was determined that 50 subjects were required for each of the diabetes treatment groups. Final sample size was selected for the incidence of a \>= 15% decrease in FEV1 end point.|Mean Difference (Final Values)|0.037|||||TWO_SIDED|95.0|0.016|0.057|||ANCOVA|||ANCOVA model with treatment site, diabetes type, and baseline FEV1||0.057|0.016|
73948476|NCT00308737|147429924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.034|||||TWO_SIDED|95.0|0.008|0.061|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FVC as a covariate||0.061|0.008|
73948477|NCT00308737|147429925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|||||TWO_SIDED|95.0|-0.042|0.031|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate||0.031|-0.042|
73948478|NCT00308737|147429926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.269|||||TWO_SIDED|95.0|-0.037|0.574|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate||0.574|-0.037|
73948479|NCT00308737|147429927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6475|||||TWO_SIDED|95.0|0.3432|1.2219|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.2219|0.3432|
73948480|NCT00308737|147429928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7504|||||TWO_SIDED|95.0|0.251|2.2431|||Regression, Logistic|||Logistic regression excluding non-diabetics||2.2431|0.2510|
73948481|NCT00308737|147429929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8953|||||TWO_SIDED|95.0|0.6703|1.1958|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.1958|0.6703|
73948482|NCT00308737|147429930|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.8509|||||TWO_SIDED|95.0|0.6722|1.077|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.0770|0.6722|
73948483|NCT00308737|147429932|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||t-test, 2 sided|||Two sample t-test||||0.112
73948484|NCT00308737|147429933|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis tested was that the difference in incidence of a decrease of ≥ 15% in FEV1 between the treatment groups not be greater than 5% for TI when compared with the usual care treatment group. Assuming an incidence rate of 15% for FEV1 and a noninferiority criterion of a 5% difference in incidence between the treatment groups, approximately 625 subjects per group were required for 80% power and an alpha of 5% (1 tailed).|Odds Ratio (OR)|-2.4767|||||TWO_SIDED|95.0|-4.5578|-0.3956|||Regression, Logistic|||Logistic regression excluding non-diabetics||-0.3956|-4.5578|
73948485|NCT01535274|147429940|SUPERIORITY||||||<|0.001|||||||ANOVA|||P-values represent comparison of successive set points within anesthetic type (i.e.: Set Point 1 compared to Set Point 2, Set Point 2 compared to Set Point 3, etc.). This P-value was determined for each of set points 1, 2, 3, 4, and 5.||||<0.001
73977251|NCT03057600|147500872|SUPERIORITY|||||||0.0243|||||||exact one-sample binomial tests|||||||0.0243
73977252|NCT01968967|147500891|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.2|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-58.3|-54.0|||MMRM|||Least square (LS) mean difference and associated 95 percent (%) confidence interval (CI), and p-value were derived from mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-54.0|-58.3|<0.001
73870563|NCT04759157|147284910|SUPERIORITY|||||||0.3|||||||mixed model|||||||.30
73948486|NCT01407354|147429958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared, Corrected|||||||0.05
73948487|NCT01407354|147429958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|threshold p value for statistical significance=0.05||||||0.024
73977253|NCT01968967|147500892|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|-36.5|-33.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.5|-36.5|<0.001
73977254|NCT01968967|147500892|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.6|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|95.0|-33.3|-29.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-29.8|-33.3|
73977255|NCT01968967|147500892|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.7|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-26.6|-22.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-22.8|-26.6|
73977256|NCT01968967|147500893|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.8|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-52.9|-48.8|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.8|-52.9|<0.001
73948488|NCT03556358|147430006|EQUIVALENCE|"Two one-sided hypothesis tests were performed for pCR in order to show that TX05 is equivalent to Herceptin:~* TEST 1: H0a: θ1 / θ2 \> 1.325 vs. H1a: θ1 / θ2 \< 1.325~* TEST 2: H0b: θ1 / θ2 \< 0.755 vs. H1b: θ1 / θ2 \> 0.755~Where θ1 is the proportion of pCR for subjects randomized to TX05 group, θ2 is the proportion of pCR for subjects randomized to Herceptin. Equivalence was concluded if the 95% CI of the risk ratio is completely contained within the pre-defined interval \[0.755, 1.325\]."|Risk Ratio (RR)|1.0783|||||TWO_SIDED|95.0|0.9185|1.2659||||||||1.2659|0.9185|
73948489|NCT01351025|147430008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in log10 IL-6||||0.94
73948490|NCT01351025|147430009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.495|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sun test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in CD4+ T-cell activation percent (% CD38+/DR+ of CD4)||||0.495
73948491|NCT01351025|147430010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.704|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in log10 D-dimer||||0.704
73948492|NCT01351025|147430011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.508|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in CD8+ T-cell activation percent (% CD38+/DR+ of CD8+)||||0.508
73948493|NCT00550550|147430030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|||=|0.001|TWO_SIDED|95.0|-2.6|-0.66|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.66|-2.60|=0.001
73948494|NCT00550550|147430031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.005|TWO_SIDED|95.0|-1.95|-0.45|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.45|-1.95|=0.005
73948495|NCT00550550|147430032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||=|0.066|TWO_SIDED|95.0|-0.88|0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||0.03|-0.88|=0.066
73948496|NCT00550550|147430033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|||=|0.042|TWO_SIDED|95.0|-0.6|-0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.03|-0.60|=0.042
73948497|NCT00697190|147430034|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|97.5|-0.29|0.04|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senoflicon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.04|-0.29|
73948498|NCT00697190|147430035|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|97.5|-0.1|0.06|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.06|-0.10|
73948499|NCT00697190|147430036|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.23|0.1|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.10|-0.23|
73948500|NCT00697190|147430037|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.25|0.04|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.04|-0.25|
73948501|NCT00697190|147430038|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|97.5|-0.16|0.07|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.07|-0.16|
73948502|NCT00697190|147430039|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|97.5|-0.25|0.14|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.14|-0.25|
73948503|NCT00697190|147430040|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|0.04|0.32|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.32|0.04|
73948504|NCT00697190|147430041|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.26|0.08|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.08|-0.26|
73948505|NCT00697190|147430042|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Median Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.08||||97.5|0.02|0.33|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.33|0.02|
74032197|NCT02749721|147617314|OTHER||Pearson's R|-0.232||||0.326|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and PDQ baseline scores||||0.326
74032198|NCT02749721|147617314|OTHER||Pearson's R|0.098||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and PDQ baseline scores||||0.68
74032199|NCT02749721|147617314|OTHER||Pearson's R|-0.073||||0.774|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and PDQ baseline to endpoint percent change||||0.774
73977257|NCT01968967|147500893|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.1|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-48.5|-43.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.8|-48.5|
73977258|NCT01968967|147500893|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.1|STANDARD_ERROR_OF_MEAN|1.28|||TWO_SIDED|95.0|-38.6|-33.6||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.6|-38.6|
73977259|NCT01968967|147500894|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.1|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-52.1|-48.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.0|-52.1|<0.001
73977260|NCT01968967|147500894|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.5|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|95.0|-47.9|-43.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.1|-47.9|
73977261|NCT01968967|147500894|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.9|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|-38.5|-33.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.3|-38.5|
73977262|NCT01968967|147500895|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.7|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|-60.2|-55.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-55.2|-60.2|<0.001
73977263|NCT01968967|147500895|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.1|STANDARD_ERROR_OF_MEAN|1.55|||TWO_SIDED|95.0|-56.1|-50.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-50.0|-56.1|
73977264|NCT01968967|147500895|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.8|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-46.2|-39.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-39.5|-46.2|
73977265|NCT01968967|147500896|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.8|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-55.9|-47.7|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-47.7|-55.9|<0.001
73977266|NCT01968967|147500896|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.0|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|-49.1|-38.8||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-38.8|-49.1|
73977267|NCT01968967|147500896|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.6|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-40.2|-29.0||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-29.0|-40.2|
73977268|NCT01968967|147500897|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.5|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-34.4|-22.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-22.5|-34.4|<0.001
73977269|NCT01968967|147500897|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|4.86|||TWO_SIDED|95.0|-40.6|-21.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-21.5|-40.6|
73977270|NCT01968967|147500897|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.3|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-36.8|-13.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.7|-36.8|
73977271|NCT01968967|147500898|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|4.5|7.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.0|4.5|<0.001
73977272|NCT01968967|147500898|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|4.2|6.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.8|4.2|
74032200|NCT02749721|147617314|OTHER||Pearson's R|0.577||||0.024|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and PDQ baseline to endpoint percent change||||0.024
73948506|NCT00697190|147430043|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|97.5|-0.27|0.26|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||0.26|-0.27|
73948507|NCT00697190|147430044|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.34|-0.08|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||-0.08|-0.34|
73948508|NCT00697190|147430045|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|97.5|-0.54|-0.15|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||-0.15|-0.54|
73948509|NCT00697190|147430046|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.12|0.14|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.14|-0.12|
73948510|NCT00697190|147430047|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.23|0.05|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.05|-0.23|
73977273|NCT01968967|147500898|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|3.7|6.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.7|3.7|
73948511|NCT00697190|147430048|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|97.5|-0.2|0.02|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.02|-0.20|
73948512|NCT00381641|147430049|SUPERIORITY|"Null (historical) response rate for iodine refractory subgroup is 10%. Power=90% for 30% alternative.~Null (historical) response rate for metastatic medullary subgroup is 5%. Power=88% for 25% alternative."|||||<|0.1||||||"For iodine refractory subgroup, null hypothesis could be rejected if 6 or more responses were observed.~For metastatic medullary subgroup, null hypothesis could be rejected if 3 or more responses were observed."|Simon, two-stage design|||Note. The objective was not to compare the two arms (subgroups), but to compare each with historical data.||||<0.10
73977274|NCT01968967|147500899|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.7|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|95.0|-53.3|-48.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.0|-53.3|
73870564|NCT04759157|147284911|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|2.05||0.206|TWO_SIDED|95.0|-6.63|1.43|||Mixed Models Analysis||This estimate is comparing intervention to control from baseline to 3 month for both patients and partners|We conducted multilevel models evaluating sleep disturbance score by assessment, group and patient versus partner status.||1.43|-6.63|.206
73870565|NCT04765202|147284926|SUPERIORITY||Percentage Difference|14.3||||1|TWO_SIDED|95.0|-11.64|40.21|||Fisher Exact||Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.|Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 1.||40.21|-11.64|1.0000
73870566|NCT04765202|147284926|SUPERIORITY||Percentage Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.|Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 2.||0|0|
73948513|NCT01598298|147430054|OTHER|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-0.82||||0.0002|TWO_SIDED|95.0|-1.24|-0.4||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for the protocol-specified stratification factors (baseline average pain and prior taxane use)|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for the stratification factors.||-0.40|-1.24|0.0002
73948514|NCT01598298|147430055|OTHER|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-1.06|||<|0.0001|TWO_SIDED|95.0|-1.57|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline worst pain score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline worst pain score and the stratification factors.||-0.55|-1.57|<0.0001
73948515|NCT01598298|147430056|OTHER|Two-sided test at the alpha=0.05 level|Coefficient fro treatment term|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.35|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline pain interference score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of pain interference scores at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline pain interference score and the stratification factors.||-0.55|-1.35|<0.0001
73948516|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.05|TWO_SIDED|95.0|0.8|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for used (injected/snorted/smoked) heroin in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.44|0.80|0.05
73948517|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.01|TWO_SIDED|95.0|1.12|2.76|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for having Used (injected/snorted/smoked) powder cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.76|1.12|0.01
73948518|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.05|TWO_SIDED|95.0|1.0|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected and/or snorted) crack cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.44|1.00|0.05
73948519|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.03|TWO_SIDED|95.0|0.35|0.98|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected/snorted/smoked) methamphetamine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||0.98|0.35|0.03
73977275|NCT01968967|147500899|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.7|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-43.5|-37.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-37.8|-43.5|
74032201|NCT02749721|147617314|OTHER||Pearson's R|0.146||||0.603|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and PDQ baseline to endpoint percent change||||0.603
73870567|NCT02305238|147284930|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) mean difference|-0.4|||||TWO_SIDED|95.0|-3.8|3.0||||||||3.0|-3.8|
73870568|NCT02305238|147284931|SUPERIORITY_OR_OTHER_LEGACY||Mantel-Haenszel (MH) adjusted difference|-0.9|||||TWO_SIDED|95.0|-5.7|4.0||||||||4.0|-5.7|
73870569|NCT02305238|147284932|SUPERIORITY_OR_OTHER_LEGACY||MH adjusted difference|-1.4|||||TWO_SIDED|95.0|-12.7|9.8||||||||9.8|-12.7|
73870570|NCT02305238|147284933|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.8|||||TWO_SIDED|95.0|-24.3|12.7||||||||12.7|-24.3|
73870571|NCT02305238|147284934|SUPERIORITY_OR_OTHER_LEGACY||MH adjusted difference|1.0|||||TWO_SIDED|95.0|-10.6|12.7||||||||12.7|-10.6|
73870572|NCT00429169|147284973|SUPERIORITY_OR_OTHER||regression coefficient|-0.29||||0.03|TWO_SIDED|95.0|-0.57|-0.023||The p-value applies to the interaction term of Treatment X Baseline Suicidal Ideation severity.|Mixed Models Analysis|||Generalized least squares model of Scale for Suicidal Ideation score during 8-week acute treatment of major depressive disorder.||-0.023|-0.57|0.03
73870573|NCT03304873|147285046|SUPERIORITY|||||||0.0004|||||||t-test, 1 sided|||||||0.0004
73870574|NCT03304873|147285047|SUPERIORITY|||||||0.99|||||||t-test, 1 sided|||||||0.99
73948520|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99|||<|0.01|TWO_SIDED|95.0|1.11|3.59|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for poly-substance use in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||3.59|1.11|<0.01
73948521|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.87|||<|0.01|TWO_SIDED|95.0|3.84|12.28|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for Heavy drinking (\>14 and \>21 drinks/week for women and men respectively) in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||12.28|3.84|<0.01
73948522|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.01|TWO_SIDED|95.0|2.02|6.5|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Drank until blacked out in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||6.50|2.02|<0.01
73948523|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.04|TWO_SIDED|95.0|0.33|0.93|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Injected daily, past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||0.93|0.33|0.04
73948524|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16|||<|0.01|TWO_SIDED|95.0|1.37|3.4|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Median number of injected partners \>= 5 in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||3.40|1.37|<0.01
73948525|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.19|TWO_SIDED|95.0|0.81|1.97|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days||1.97|0.81|0.19
73948526|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||<|0.01|TWO_SIDED|95.0|1.01|2.55|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Injected with someone else's used needle/syringe in the past 30 days|Adjusted odds ratio with 95 % confidence interval for travel in prior 3 months as a risk factor for having injected with someone else's used needle/syringe in the past 30 days||2.55|1.01|<0.01
73977276|NCT01968967|147500900|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.2|-20.0|
73977277|NCT01968967|147500900|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-12.6|-20.7|
73977278|NCT01968967|147500900|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.0|-16.5|
73948527|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.07|||<|0.01|TWO_SIDED|95.0|1.79|5.27|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days||5.27|1.79|<0.01
73948528|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.01|TWO_SIDED|95.0|1.34|3.32|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Shared cooker/spook to prepare drugs in the past 30 days|Adjusted odds ratios with 95% confidence interval for travel in prior 3 months as risk factor for risk behaviors||3.32|1.34|<0.01
73948529|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87|||<|0.01|TWO_SIDED|95.0|1.19|2.95|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having used Backloaded Syringe in the past 30 days|Adjusted odds with 95 % confidence interval for travel as a risk factor for risk behaviors||2.95|1.19|<0.01
73948530|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.13|TWO_SIDED|95.0|0.83|2.1|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|"Adjusted odds for travel in prior 3 months as a risk factor for having done Someone's rinse in the past 30 days"|Adjusted odds with 95% confidence interval for travel in prior 3 months as a risk factor for risk behavior in past 30 days||2.10|0.83|0.13
73948531|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21|||<|0.01|TWO_SIDED|95.0|1.4|3.49|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for Median number of sexual partners \>=2 in the past 30 days|Adjusted odds ratios and 95% confidence intervals for travel in prior 3 months as a risk factor for risk behaviors in past 30 days||3.49|1.40|<0.01
73948532|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.86|TWO_SIDED|95.0|0.45|1.85|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Traded sex for money or drugs in the past 30 days|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for risk behaviors in past 30 days||1.85|0.45|0.86
73977279|NCT01968967|147500901|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|2.4|4.3||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.3|2.4|
73977280|NCT01968967|147500901|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|2.5|4.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.5|2.5|
73977281|NCT01968967|147500901|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|2.7|4.9||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.9|2.7|
73977282|NCT01968967|147500902|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-0.9|1.4||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||1.4|-0.9|
73977283|NCT01968967|147500902|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-0.1|2.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.3|-0.1|
73977284|NCT01968967|147500902|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|0.3|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.7|0.3|
73977285|NCT01968967|147500903|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.2|-20.0|
73977286|NCT01968967|147500903|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-12.6|-20.7|
73977287|NCT01968967|147500903|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.0|-16.5|
73977288|NCT01968967|147500904|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-63.1|-57.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-57.6|-63.1|
73977289|NCT01968967|147500905|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.8|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-68.3|-57.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-57.3|-68.3|
73977290|NCT01968967|147500906|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.0|STANDARD_ERROR_OF_MEAN|1.27|||TWO_SIDED|95.0|-63.5|-58.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-58.5|-63.5|
73977291|NCT01968967|147500907|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.7|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-66.6|-60.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-60.9|-66.6|
73977292|NCT01968967|147500908|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.4|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-69.3|-63.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-63.6|-69.3|
73977293|NCT01968967|147500909|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.8|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|95.0|-47.7|-43.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.9|-47.7|
73977294|NCT01968967|147500910|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-11.8|-9.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.3|-11.8|
74032202|NCT02749721|147617314|OTHER||Pearson's R|-0.232||||0.326|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and PDQ baseline to endpoint percent change||||0.326
74032203|NCT02749721|147617314|OTHER||Pearson's R|0.098||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and PDQ baseline to endpoint percent change||||0.68
73948533|NCT00244374|147430080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.73|TWO_SIDED|95.0|0.59|2.02|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for condom use \>90% (if sexually active)|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for engaging in risk behavior during the past 30 days||2.02|0.59|0.73
73948534|NCT01966796|147430098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||ANOVA|||The incidence of MDR pathogens (6.7%, 25.5%, 36.9% and 44.6% in PSI II, III, IV, and V, respectively, p=0.002) and mortality rate (0, 5.9%, 12.3%, and 23.8%, respectively, p\<0.001) increased with increasing PSI||||0.002
73948535|NCT00474929|147430109|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose (MTD) Level|1.0|||||TWO_SIDED||||||||Dose Level 1 was chosen as the MTD due to PI concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2. For the best interest of the patients, dose level 1 was chosen as the MTD and the dose level for Phase II.|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).||||
73948536|NCT03661996|147430115|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|1.063|STANDARD_ERROR_OF_MEAN|1.0216|||TWO_SIDED|95.0|1.019|1.108|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.108|1.019|
73948537|NCT03661996|147430115|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|0.959|STANDARD_ERROR_OF_MEAN|1.0221|||TWO_SIDED|95.0|0.919|1.001|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.001|0.919|
73948538|NCT03661996|147430115|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|1.013|STANDARD_ERROR_OF_MEAN|1.0219|||TWO_SIDED|95.0|0.97|1.057|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.057|0.970|
73948539|NCT03661996|147430115|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|0.931|STANDARD_ERROR_OF_MEAN|1.0219|||TWO_SIDED|95.0|0.892|0.972|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||0.972|0.892|
73948540|NCT03661996|147430116|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|17.15|STANDARD_ERROR_OF_MEAN|1.396|<|0.0001|TWO_SIDED|95.0|14.4|19.9|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||19.90|14.40|<0.0001
73948541|NCT03661996|147430116|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Mean Difference (Final Values)|20.41|STANDARD_ERROR_OF_MEAN|3.692|<|0.0001|TWO_SIDED|95.0|12.79|28.03|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||28.03|12.79|<0.0001
73977295|NCT01968967|147500911|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|2.1|3.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.3|2.1|
73977296|NCT01968967|147500912|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-1.6|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.5|-1.6|
73977297|NCT01968967|147500912|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-1.5|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.3|-1.5|
73870575|NCT00250276|147285059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% Confidence Interval (CI) of the GMC ratio between lots was within \[0.5;2\] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.04|||||TWO_SIDED|95.0|0.81|1.34|||ANOVA|The ANOVA model on the logarithm (log)10 transformation of the concentrations. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.34|0.81|
73870576|NCT00250276|147285059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.19|||||TWO_SIDED|95.0|0.95|1.49|||ANOVA|The ANOVA model on the log10 transformation of theconcentrations. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.49|0.95|
73948542|NCT03661996|147430116|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|20.05|STANDARD_ERROR_OF_MEAN|0.819|<|0.0001|TWO_SIDED|95.0|18.44|21.66|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||21.66|18.44|<0.0001
73948543|NCT03661996|147430116|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|18.4|STANDARD_ERROR_OF_MEAN|1.011|<|0.0001|TWO_SIDED|95.0|16.41|20.38|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||20.38|16.41|<0.0001
73948544|NCT03661996|147430117|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.45|STANDARD_ERROR_OF_MEAN|1.478|<|0.0001|TWO_SIDED|95.0|19.54|25.37|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||25.37|19.54|<0.0001
73948545|NCT03661996|147430117|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|23.9|STANDARD_ERROR_OF_MEAN|4.613|<|0.0001|TWO_SIDED|95.0|14.38|33.42|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||33.42|14.38|<0.0001
73948546|NCT03661996|147430117|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.62|STANDARD_ERROR_OF_MEAN|0.865|<|0.0001|TWO_SIDED|95.0|23.92|27.32|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.32|23.92|<0.0001
73977298|NCT01968967|147500912|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-1.2|-1.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.0|-1.2|
73977299|NCT01968967|147500913|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
73977300|NCT01968967|147500913|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
73977301|NCT01968967|147500913|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-0.3|
73977302|NCT01968967|147500914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.0|||||TWO_SIDED|95.0|19.21|38.02||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||38.02|19.21|
74032204|NCT02749721|147617314|OTHER||Pearson's R|-0.1||||0.692|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and MGH-CPFQ baseline scores||||0.692
74032205|NCT02749721|147617314|OTHER||Pearson's R|0.498||||0.059|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and MGH-CPFQ baseline scores||||0.059
74032206|NCT02749721|147617314|OTHER||Pearson's R|-0.332||||0.227|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and MGH-CPFQ baseline scores||||0.227
73948547|NCT03661996|147430117|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.1|STANDARD_ERROR_OF_MEAN|1.053|<|0.0001|TWO_SIDED|95.0|20.03|24.17|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||24.17|20.03|<0.0001
73948548|NCT03661996|147430118|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|21.1|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|17.6|24.5|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||24.5|17.6|<0.0001
73948549|NCT03661996|147430118|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.3|STANDARD_ERROR_OF_MEAN|6.06||0.0003|TWO_SIDED|95.0|12.7|37.8|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||37.8|12.7|0.0003
73948550|NCT03661996|147430118|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.85|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|95.0|23.82|27.88|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||27.88|23.82|<0.0001
73977303|NCT01968967|147500914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.9|||||TWO_SIDED|95.0|9.84|16.86||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||16.86|9.84|
73977304|NCT01968967|147500914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.3|||||TWO_SIDED|95.0|4.99|8.06||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||8.06|4.99|
73977305|NCT01968967|147500915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|86.5|||||TWO_SIDED|95.0|61.74|121.25||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||121.25|61.74|
73977306|NCT01968967|147500915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|35.9|||||TWO_SIDED|95.0|26.83|47.96||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||47.96|26.83|
73977307|NCT01968967|147500915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.5|||||TWO_SIDED|95.0|18.9|34.47||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||34.47|18.90|
73977308|NCT00989196|147500954|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the comparison of the PK profile of Human-cl rhFVIII with Kogenate, the 90% confidence intervals for the ratio or log-ratio of Human-cl rhFVIII over Kogenate for selected, dose independent or dose adjusted, PK parameters will be presented. In addition a formal statistical procedure will test whether the ratio of mean AUCs is within a 80 to 125% range to show bioequivalence.|Ratio|0.98|||||TWO_SIDED|90.0|0.874|1.107||||||||1.107|0.874|
73977309|NCT01000805|147500963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.33||This p-value is for the main effect of treatment.|Mixed Models Analysis|||||-0.33|-0.90|<0.001
74032207|NCT02749721|147617314|OTHER||Pearson's R|-0.125||||0.6|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and MGH-CPFQ baseline scores||||0.600
73977310|NCT01000805|147500964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04|||<|0.001|TWO_SIDED|95.0|-5.83|-2.24|||Mixed Models Analysis|||||-2.24|-5.83|<0.001
73977311|NCT01000805|147500965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.112|TWO_SIDED|95.0|-1.03|0.11||This is the p-value for the Disrupt Work/School Work score.|Mixed Models Analysis|||||0.11|-1.03|0.112
73977312|NCT01000805|147500965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.005|TWO_SIDED|95.0|-1.24|-0.22||This the p-value for the Disrupt Social Life/Leisure score.|Mixed Models Analysis|||||-0.22|-1.24|0.005
73977313|NCT01000805|147500965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.04|TWO_SIDED|95.0|-1.04|-0.02||This is the p-value for the Disrupt Family Life/Home score.|Mixed Models Analysis|||||-0.02|-1.04|0.040
73977314|NCT01000805|147500965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.019|TWO_SIDED|95.0|-3.2|-0.29||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-0.29|-3.20|0.019
73977315|NCT01000805|147500966|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||0.001
74032208|NCT02749721|147617314|OTHER||Pearson's R|-0.096||||0.69|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and MGH-CPFQ baseline scores||||0.69
74032209|NCT02749721|147617314|OTHER||Pearson's R|0.259||||0.315|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and MGH-CPFQ baseline to endpoint percent change||||0.315
73948551|NCT03661996|147430118|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|23.34|STANDARD_ERROR_OF_MEAN|1.238|<|0.0001|TWO_SIDED|95.0|20.91|25.78|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||25.78|20.91|<0.0001
73948552|NCT03661996|147430119|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|20.86|STANDARD_ERROR_OF_MEAN|1.481|<|0.0001|TWO_SIDED|95.0|17.94|23.78|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||23.78|17.94|<0.0001
73948553|NCT03661996|147430119|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.66|STANDARD_ERROR_OF_MEAN|4.568|<|0.0001|TWO_SIDED|95.0|16.24|35.09|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||35.09|16.24|<0.0001
73948554|NCT03661996|147430119|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.57|STANDARD_ERROR_OF_MEAN|0.861|<|0.0001|TWO_SIDED|95.0|23.88|27.26|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.26|23.88|<0.0001
73948555|NCT03661996|147430119|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.69|STANDARD_ERROR_OF_MEAN|0.853|<|0.0001|TWO_SIDED|95.0|24.02|27.37|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.37|24.02|<0.0001
73948556|NCT03661996|147430120|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.17|STANDARD_ERROR_OF_MEAN|2.248|<|0.0001|TWO_SIDED|95.0|20.74|29.6|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||29.60|20.74|<0.0001
73948557|NCT03661996|147430120|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|33.11|STANDARD_ERROR_OF_MEAN|5.795|<|0.0001|TWO_SIDED|95.0|21.15|45.07|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||45.07|21.15|<0.0001
73948558|NCT03661996|147430120|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|27.8|STANDARD_ERROR_OF_MEAN|1.233|<|0.0001|TWO_SIDED|95.0|25.38|30.23|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||30.23|25.38|<0.0001
73948559|NCT03661996|147430120|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|24.8|STANDARD_ERROR_OF_MEAN|1.598|<|0.0001|TWO_SIDED|95.0|21.66|27.94|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.94|21.66|<0.0001
73977316|NCT01000805|147500967|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||This is the third gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||0.0082
73977317|NCT01000805|147500968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|||<|0.001|TWO_SIDED|95.0|-5.2|-2.11||This is the fourth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-2.11|-5.20|<0.001
73977318|NCT01000805|147500969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19||||0.001|TWO_SIDED|95.0|-3.5|-0.89||This is the fifth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-0.89|-3.50|0.001
73977319|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.97|-0.32||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.32|-0.97|<0.001
73948560|NCT03661996|147430121|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.1|STANDARD_ERROR_OF_MEAN|1.898|<|0.0001|TWO_SIDED|95.0|18.37|25.84|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||25.84|18.37|<0.0001
73948561|NCT03661996|147430121|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|16.75|STANDARD_ERROR_OF_MEAN|6.255|<|0.0001|TWO_SIDED|95.0|3.84|29.66|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||29.66|3.84|<0.0001
73948562|NCT03661996|147430121|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|21.52|STANDARD_ERROR_OF_MEAN|1.062|<|0.0001|TWO_SIDED|95.0|19.43|23.6|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||23.60|19.43|<0.0001
73948563|NCT03661996|147430121|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|19.4|STANDARD_ERROR_OF_MEAN|1.365|<|0.0001|TWO_SIDED|95.0|16.72|22.09|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||22.09|16.72|<0.0001
73977320|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.34||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.34|-0.90|<0.001
73977321|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.33||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.33|-0.90|<0.001
73977322|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001|TWO_SIDED|95.0|-1.06|-0.42||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.42|-1.06|<0.001
73977323|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-1.03|-0.33||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.33|-1.03|<0.001
73977324|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.09|-0.37||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.37|-1.09|<0.001
73977325|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.009|TWO_SIDED|95.0|-0.79|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.11|-0.79|0.009
73977326|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.002|TWO_SIDED|95.0|-0.91|-0.21||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.21|-0.91|0.002
74032210|NCT02749721|147617314|OTHER||Pearson's R|0.002||||0.996|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and MGH-CPFQ baseline to endpoint percent change||||0.996
73977327|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.06|-0.35||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.35|-1.06|<0.001
73977328|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.042|TWO_SIDED|95.0|-0.76|-0.01||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.01|-0.76|0.042
73977329|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|||<|0.001|TWO_SIDED|95.0|-1.03|-0.31||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.31|-1.03|<0.001
73977330|NCT01000805|147500970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.88|-0.25||This is the p-value for the main effect of treatment for the BPI Mean Pain Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.25|-0.88|<0.001
74032211|NCT02749721|147617314|OTHER||Pearson's R|0.234||||0.544|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and MGH-CPFQ baseline to endpoint percent change||||0.544
74032212|NCT02749721|147617314|OTHER||Pearson's R|0.455||||0.066|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and MGH-CPFQ baseline to endpoint percent change||||0.066
73948564|NCT03661996|147430122|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.48|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-3.86|-3.1|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.10|-3.86|<0.0001
73948565|NCT03661996|147430122|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.52|STANDARD_ERROR_OF_MEAN|0.416|<|0.0001|TWO_SIDED|95.0|-4.38|-2.67|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-2.67|-4.38|<0.0001
73948566|NCT03661996|147430122|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-4.02|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-4.25|-3.79|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.79|-4.25|<0.0001
73948567|NCT03661996|147430122|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.72|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-3.96|-3.48|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.48|-3.96|<0.0001
73948568|NCT01965158|147430163|SUPERIORITY_OR_OTHER||Difference|13.0|STANDARD_ERROR_OF_MEAN|4.19||0.002|TWO_SIDED|95.0|4.8|21.3||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.||||21.3|4.8|0.0020
73948569|NCT01965158|147430164|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.271|<|0.0001|TWO_SIDED|95.0|0.77|1.83|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.83|0.77|<0.0001
73948570|NCT01965158|147430165|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.6|2.63|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||2.63|1.60|<0.0001
73948571|NCT01965158|147430166|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.54|1.48|||ANCOVA|ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.48|0.54|<0.0001
73948572|NCT01965158|147430167|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.198||0.0003|TWO_SIDED|95.0|0.34|1.12|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.12|0.34|0.0003
73977331|NCT01000805|147500971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.71|-0.26||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.26|-0.71|<0.001
73977332|NCT01000805|147500972|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||This is the p-value for suicidal ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.293
73977333|NCT01000805|147500973|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.033
73977334|NCT01000805|147500974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.92|||<|0.001|TWO_SIDED|95.0|1.34|4.51||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||4.51|1.34|<0.001
73977335|NCT01000805|147500974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.001|TWO_SIDED|95.0|0.97|3.83||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.83|0.97|0.001
73977336|NCT01000805|147500975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.083|TWO_SIDED|95.0|-0.25|4.04||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||4.04|-0.25|0.083
73948573|NCT03560258|147430177|SUPERIORITY|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.137
73948574|NCT03560258|147430177|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.014
73948575|NCT03560258|147430177|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.100
73948576|NCT03560258|147430179|SUPERIORITY|||||||0.222|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||0.222
73948577|NCT03560258|147430179|SUPERIORITY|||||||0.222|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||0.222
73977337|NCT01000805|147500975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.513|TWO_SIDED|95.0|-0.95|1.9||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||1.90|-0.95|0.513
73977338|NCT01000805|147500975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.124|TWO_SIDED|95.0|-0.42|3.47||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.47|-0.42|0.124
73977339|NCT01000805|147500975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.638|TWO_SIDED|95.0|-0.98|1.6||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||1.60|-0.98|0.638
73977340|NCT01000805|147500976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||<|0.001|TWO_SIDED|95.0|-1.37|-0.54||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.54|-1.37|<0.001
73977341|NCT01000805|147500976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.24|-0.51||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||-0.51|-1.24|<0.001
73977342|NCT04278833|147500979|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||<0.001
73977343|NCT04278833|147500979|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||<0.001
73977344|NCT04278833|147500979|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||<0.001
73948578|NCT03560258|147430179|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||1.00
73948579|NCT03560258|147430180|SUPERIORITY|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.678
73977345|NCT04278833|147500980|OTHER|||||||0.28||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at week 2||||0.280
74032213|NCT02749721|147617314|OTHER||Pearson's R|-0.28||||0.293|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and MGH-CPFQ baseline to endpoint percent change||||0.293
73977346|NCT04278833|147500980|OTHER|||||||0.07||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at month 3||||0.070
73977347|NCT04278833|147500980|OTHER|||||||0.851||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at month 6||||0.851
73977348|NCT04278833|147500981|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||<0.001
73977349|NCT04278833|147500981|OTHER|||||||0.021||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||0.021
73977350|NCT04278833|147500981|OTHER|||||||0.044||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||0.044
73977351|NCT04278833|147500982|OTHER|||||||0.226||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||0.226
73977352|NCT04278833|147500982|OTHER|||||||0.071||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||0.071
73977353|NCT04278833|147500982|OTHER|||||||0.382||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||0.382
73977354|NCT04278833|147500983|OTHER|||||||0.152||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||0.152
73977355|NCT04278833|147500983|OTHER|||||||0.261||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3.||||0.261
73977356|NCT04278833|147500983|OTHER|||||||0.437||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6.||||0.437
73977357|NCT04278833|147500984|OTHER|||||||0.128||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.128
73977358|NCT04278833|147500984|OTHER||||||>|0.999||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||>0.999
73977359|NCT04278833|147500985|OTHER|||||||0.04||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.040
73977360|NCT04278833|147500985|OTHER||||||>|0.999||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||>0.999
73977361|NCT03789656|147501003|OTHER|||||||0.6285|||||||Wilcoxon Signed Rank test|||The primary efficacy endpoint was completed with the Efficacy Analysis Set (EAS), which included all treated subjects in Group 1. The median (Interquartile range) for change from baseline in IGF-1xULN to Week 13/EoT and p-value from the Wilcoxon signed rank test were presented. Baseline was defined as the mean of all IGF-1xULN values prior to first dose. Last on treatment assessment was used for EoT if subject discontinued before Week 13.||||0.6285
73977362|NCT03789656|147501004|OTHER|||||||0.3877|||||||exact binomial test assuming the null pr|Null proportion = 0.5||||||0.3877
73977363|NCT06214052|147501034|OTHER||Emax|-2.69|STANDARD_ERROR_OF_MEAN|5.0||||||||||||||||
73977364|NCT06214052|147501034|OTHER||EC50|1.88|STANDARD_ERROR_OF_MEAN|26.0||||||||||||||||
73948580|NCT03560258|147430180|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.037
73948581|NCT03560258|147430180|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.100
74032214|NCT02749721|147617314|OTHER||Pearson's R|0.783||||0.013|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and WLQ baseline scores||||0.013
74032215|NCT02749721|147617314|OTHER||Pearson's R|0.135||||0.799|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and WLQ baseline scores||||0.799
74032216|NCT02749721|147617314|OTHER||Pearson's R|0.506||||0.201|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and WLQ baseline scores||||0.201
74032217|NCT02749721|147617314|OTHER||Pearson's R|-0.197||||0.586|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and WLQ baseline scores||||0.586
74032218|NCT02749721|147617314|OTHER||Pearson's R|-0.024||||0.95|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and WLQ baseline scores||||0.95
74032219|NCT02749721|147617314|OTHER||Pearson's R|0.039||||0.92|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and WLQ baseline to endpoint percent change||||0.920
74032220|NCT02749721|147617314|OTHER||Pearson's R|0.113||||0.831|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and WLQ baseline to endpoint percent change||||0.831
74032221|NCT02749721|147617314|OTHER||Pearson's R|0.655||||0.23|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and WLQ baseline to endpoint percent change||||0.230
74032222|NCT02749721|147617314|OTHER||Pearson's R|-0.602||||0.115|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and WLQ baseline to endpoint percent change||||0.115
74032223|NCT02749721|147617314|OTHER||Pearson's R|-0.313||||0.45|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and WLQ baseline to endpoint percent change||||0.450
74032224|NCT01519245|147617328|SUPERIORITY_OR_OTHER|||||||0.0493||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of primary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.0493
74032225|NCT01519245|147617330|SUPERIORITY_OR_OTHER|||||||0.1876||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.1876
74032226|NCT01519245|147617331|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.0930
74032227|NCT03596177|147617389|SUPERIORITY||Mean Difference (Net)|-2.58||||0.011|TWO_SIDED|90.0|-4.15|-1.0|||ANCOVA|||||-1.00|-4.15|0.011
74032228|NCT03596177|147617390|SUPERIORITY||Mean Difference (Net)|-45.481||||0.002|TWO_SIDED|90.0|-67.777|-23.186|||ANCOVA|||Statistical Analysis for Day 32||-23.186|-67.777|0.002
74032229|NCT03596177|147617390|SUPERIORITY||Mean Difference (Net)|-41.323||||0.011|TWO_SIDED|90.0|-66.74|-15.907|||ANCOVA|||Statistical Analysis for Day 59||-15.907|-66.740|0.011
74032230|NCT03596177|147617391|SUPERIORITY||Mean Difference (Net)|-1551.194|||<|0.001|TWO_SIDED|90.0|-2190.515|-911.873|||ANCOVA|||Statistical Analysis for Day 32||-911.873|-2190.515|<0.001
74032231|NCT03596177|147617391|SUPERIORITY||Mean Difference (Net)|-1332.515||||0.015|TWO_SIDED|90.0|-2187.711|-477.318|||ANCOVA|||Statistical Analysis for Day 59||-477.318|-2187.711|0.015
74032232|NCT03596177|147617392|SUPERIORITY||Mean Difference (Net)|-3.173||||0.384|TWO_SIDED|90.0|-9.368|3.022|||ANCOVA|||||3.022|-9.368|0.384
74032233|NCT03596177|147617393|SUPERIORITY||Mean Difference (Net)|-10.039||||0.351|TWO_SIDED|90.0|-28.287|8.209|||ANCOVA|||||8.209|-28.287|0.351
74032234|NCT03596177|147617394|SUPERIORITY||Mean Difference (Net)|0.186||||0.968|TWO_SIDED|90.0|-7.858|8.229|||ANCOVA|||||8.229|-7.858|0.968
74032235|NCT03596177|147617395|SUPERIORITY||Mean Difference (Net)|0.867||||0.58|TWO_SIDED|90.0|-1.81|3.545|||ANCOVA|||||3.545|-1.810|0.580
74032236|NCT03596177|147617396|SUPERIORITY||Mean Difference (Net)|-3.645||||0.324|TWO_SIDED|90.0|-9.894|2.603|||ANCOVA|||||2.603|-9.894|0.324
74032237|NCT03596177|147617397|SUPERIORITY||Mean Difference (Net)|-5.672||||0.412|TWO_SIDED|90.0|-17.415|6.072|||ANCOVA|||||6.072|-17.415|0.412
74032238|NCT03596177|147617398|SUPERIORITY||Mean Difference (Net)|7.357||||0.177|TWO_SIDED|90.0|-1.742|16.456|||ANCOVA|||||16.456|-1.742|0.177
74032239|NCT03596177|147617399|SUPERIORITY||Mean Difference (Net)|15.186||||0.168|TWO_SIDED|90.0|-3.151|33.523|||ANCOVA|||||33.523|-3.151|0.168
74032240|NCT03596177|147617400|SUPERIORITY||Mean Difference (Net)|-2.54||||0.009|TWO_SIDED|90.0|-4.05|-1.03|||ANCOVA|||||-1.03|-4.05|0.009
74032241|NCT03596177|147617401|SUPERIORITY||Mean Difference (Net)|-5.122||||0.107|TWO_SIDED|90.0|-10.364|0.119|||ANCOVA|||||0.119|-10.364|0.107
74032242|NCT03596177|147617402|SUPERIORITY||Mean Difference (Net)|-1.848||||0.085|TWO_SIDED|90.0|-3.605|-0.091|||ANCOVA|||||-0.091|-3.605|0.085
74032243|NCT03596177|147617403|SUPERIORITY||Mean Difference (Net)|-3.159||||0.204|TWO_SIDED|90.0|-7.326|1.007|||ANCOVA|||||1.007|-7.326|0.204
74032244|NCT03596177|147617404|SUPERIORITY||Mean Difference (Net)|-0.019||||0.145|TWO_SIDED|90.0|-0.041|0.003|||ANCOVA|||||0.003|-0.041|0.145
74032245|NCT03596177|147617405|SUPERIORITY||Mean Difference (Net)|-26.001||||0.001|TWO_SIDED|90.0|-37.801|-14.201|||ANCOVA|||||-14.201|-37.801|0.001
74032246|NCT03596177|147617406|SUPERIORITY||Mean Difference (Net)|-12.332||||0.01|TWO_SIDED|90.0|-19.726|-4.938|||ANCOVA|||||-4.938|-19.726|0.010
74032247|NCT01301742|147617412|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.5|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|151.77|165.53|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)|||165.53|151.77|
74032248|NCT01301742|147617413|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|115.0|STANDARD_DEVIATION|13.8|||TWO_SIDED|90.0|106.15|124.59|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual gCV|||124.59|106.15|
74032249|NCT01301742|147617414|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.29|STANDARD_DEVIATION|7.7|||TWO_SIDED|90.0|151.41|165.49|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual gCV|||165.49|151.41|
73948582|NCT03560258|147430181|SUPERIORITY|||||||0.303|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.303
73948583|NCT03560258|147430181|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.457
73948584|NCT03560258|147430181|SUPERIORITY|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.678
73948585|NCT03560258|147430182|SUPERIORITY|||||||0.755|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in change in the magnitude of CD8 T cell responses from week 0 to week 26.||||0.755
73948586|NCT03560258|147430182|SUPERIORITY|||||||0.867|||||||Wilcoxon (Mann-Whitney)|||||||0.867
73948587|NCT03560258|147430182|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
73948588|NCT02006121|147430183|SUPERIORITY|||||||0.0047|||||||Mixed Models Analysis|||||||0.0047
73948589|NCT02006121|147430184|SUPERIORITY|||||||0.0022|||||||Mixed Models Analysis|||||||0.0022
73977365|NCT02434328|147501039|NON_INFERIORITY|The noninferiority margin was 4 letters.|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-2.4|1.0||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.0|-2.4|<0.0001
73977366|NCT02434328|147501040|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|-2.8|0.5||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||0.5|-2.8|0.0003
74032250|NCT03059810|147617469|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|2.63|||TWO_SIDED|95.0|-4.6|5.9|||Linear mixed model (LMM)|A 95% Confidence Interval for the least squares mean difference between the follow up and baseline was used to test for non-inferiority.|Mean difference was calculated as Test (at 12-16 days follow up) - Habitual (at baseline)|It was a single arm study and the subjects' overall vision was compared against the baseline with the habitual lens. Sample size was determined using Power procedure in SAS 9.4 using the input from historical data (alpha=0.05).||5.9|-4.6|
73948590|NCT02006121|147430185|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73948591|NCT02006121|147430186|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
73948592|NCT02006121|147430187|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73948593|NCT02223065|147430216|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.975||||0.495|TWO_SIDED|90.0|0.915|1.038|||ANOVA|||||1.038|0.915|0.4950
73948594|NCT02223065|147430217|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.993||||0.865|TWO_SIDED|90.0|0.932|1.06|||ANOVA|||||1.060|0.932|0.8650
73948595|NCT02223065|147430218|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.022||||0.2344|TWO_SIDED|90.0|0.991|1.054|||ANOVA|||||1.054|0.991|0.2344
73948596|NCT02223065|147430219|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.016||||0.2458|TWO_SIDED|90.0|0.993|1.038|||ANOVA|||||1.038|0.993|0.2458
73948597|NCT02223065|147430220|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.024||||0.1947|TWO_SIDED|90.0|0.993|1.056|||ANOVA|||||1.056|0.993|0.1947
73948598|NCT02223065|147430221|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.013||||0.3191|TWO_SIDED|90.0|0.992|1.034|||ANOVA|||||1.034|0.992|0.3191
73948599|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.4|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.4
73948600|NCT01614847|147430222|EQUIVALENCE|two-tailed, alpha = 0.05||||||0.109|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.109
73948601|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.779|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.779
73948602|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.262|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.262
74032251|NCT03395197|147617550|SUPERIORITY||Hazard Ratio (HR)|0.627|||<|0.0001|TWO_SIDED|95.0|0.506|0.777||1-sided|Log Rank||Hazard ratio was based on Cox proportional hazards model; under proportional hazards, if hazard ratio \< 1, it indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.|The following statistical hypotheses was tested to address the primary objectives: H01: HRrPFS ≥1 vs H11: HRrPFS \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the all-comers population for Part 2 Cohort 1.||0.777|0.506|<0.0001
74032252|NCT03395197|147617551|SUPERIORITY||Hazard Ratio (HR)|0.447|||<|0.0001|TWO_SIDED|95.0|0.328|0.61||1-sided|Log Rank||Hazard ratio was based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.|The following statistical hypotheses was tested to address the primary objectives: H02: HRrPFS+ ≥1 vs H12: HRrPFS+ \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the DDR deficient population for Part 2 Cohort 2.||0.610|0.328|<0.0001
74032253|NCT05137041|147617552|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
74032254|NCT05137041|147617554|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.015|TWO_SIDED|95.0|-0.817|-0.137|||ANCOVA|The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).||||-0.137|-0.817|0.015
74032255|NCT05137041|147617555|SUPERIORITY||Least Square Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|8.47||0.103|TWO_SIDED|95.0|-32.661|0.828||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||0.828|-32.661|0.103
74032256|NCT05137041|147617556|SUPERIORITY||Least Square Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|0.511|1.581||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||1.581|0.511|<0.001
74032257|NCT05137041|147617557|SUPERIORITY||Least Square Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.82||0.121|TWO_SIDED|95.0|-2.976|0.25||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||0.250|-2.976|0.121
74032258|NCT05137041|147617558|SUPERIORITY|||||||0.564||||||The p-value is adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|Log Rank|||||||0.564
74032259|NCT05137041|147617559|SUPERIORITY|||||||0.289|||||||Log Rank|||||||0.289
74089284|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0006|TWO_SIDED|95.0|1.32|2.79|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|1.32|0.0006
74089285|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0002|TWO_SIDED|95.0|1.41|3.05|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.05|1.41|0.0002
73948603|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.150
74032260|NCT05137041|147617560|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||Change from Baseline at Day 1 Evening||||0.001
73948604|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.726|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.726
74032261|NCT05137041|147617560|SUPERIORITY|||||||0.035|||||||Satterthwaite t-test|||Change from Baseline at Day 2 Morning||||0.035
74032262|NCT05137041|147617560|SUPERIORITY|||||||0.004|||||||Satterthwaite t-test|||Change from Baseline at Day 2 Evening||||0.004
74032263|NCT05137041|147617560|SUPERIORITY|||||||0.007|||||||Satterthwaite t-test|||Change from Baseline at Day 3 Morning||||0.007
74032264|NCT05137041|147617560|SUPERIORITY|||||||0.005|||||||Satterthwaite t-test|||Change from Baseline at Day 3 Evening||||0.005
74032265|NCT05137041|147617560|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||Change from Baseline at Day 4 Morning||||0.001
74032266|NCT05137041|147617560|SUPERIORITY|||||||0.007|||||||Satterthwaite t-test|||Change from Baseline at Day 4 Evening||||0.007
74032267|NCT05137041|147617560|SUPERIORITY|||||||0.096|||||||Satterthwaite t-test|||Change from Baseline at Day 5 Morning||||0.096
74032268|NCT05137041|147617560|SUPERIORITY|||||||0.015|||||||Satterthwaite t-test|||Change from Baseline at Day 5||||0.015
74032269|NCT05137041|147617561|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 1 Evening||||<0.001
74032270|NCT05137041|147617561|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||VRS: Day 2 Morning||||0.001
74032271|NCT05137041|147617561|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 2 Evening||||<0.001
74032272|NCT05137041|147617561|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 3 Morning||||<0.001
74032273|NCT05137041|147617561|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 3 Evening||||<0.001
74032274|NCT05137041|147617561|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 4 Morning||||<0.001
74032275|NCT05137041|147617561|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 4 Evening||||<0.001
74032276|NCT05137041|147617561|SUPERIORITY|||||||0.024|||||||Satterthwaite t-test|||VRS: Day 5 Morning||||0.024
74032277|NCT05137041|147617561|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 5||||<0.001
74032278|NCT05137041|147617562|SUPERIORITY||Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.415|0.903|||ANCOVA|||||0.903|0.415|<0.001
74032279|NCT03470922|147617575|SUPERIORITY||Cox Proportional Hazard|0.75||||0.0055|TWO_SIDED|95.0|0.62|0.92|||Log Rank|Log-rank test stratified by LAG-3 (≥ 1% vs \< 1%), BRAF (mutation positive vs mutation wild-type), AJCC M-stage (M0/M1any\[0\] vs M1any\[1\])||||0.92|0.62|0.0055
74032280|NCT00051558|147617651|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
73948605|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.055|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.055
73948606|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.945|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.945
73948607|NCT01614847|147430222|EQUIVALENCE|Alpha = 0.05||||||0.844|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.844
73948608|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.945||||||df=7|Wilcoxon (Mann-Whitney)|||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.945
73948609|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.383||||||Alpha = 0.05|Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.383
73948610|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.383|||||||Wilcoxon (Mann-Whitney)|df=7||Mean change in osmolarity from baseline. H0: No change (e.g. mean change = 0) H1: Significant change (mean change ≠ 0)||||0.383
73948611|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.672|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.672
73948612|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.107|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.107
73948613|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.64|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.64
73948614|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.04|||||||Wilcoxon (Mann-Whitney)|df=14||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.040
73948615|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.2|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.20
73977367|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.0|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||0.0|-2.0|
73948616|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df-=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.150
73948617|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.73|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.730
73948618|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.89
73948619|NCT01614847|147430222|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.89
73948620|NCT01003184|147430227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.6|||<|0.0001|TWO_SIDED|95.0|3.17|13.73|||Regression, Logistic|Logistic regression model includes treatment group, use of SU (yes/no), baseline HbA1c and baseline weight as main factors.||"Primary objective: to test hypothesis that the percentage of patients with HbA1c ≤7.0% with weight loss (≥1.0 kg) after exenatide QW is superior to insulin detemir.~Sample size estimation: based on the test for difference in percentage between Exenatide QW and insulin detemir. Assuming: common drop-out rate 20%, response rate at endpoint 50% in the exenatide QW group and 25% in the insulin detemir group; 5% significance. 214 patients will provide 90% power to detect a difference."||13.73|3.17|<.0001
73948621|NCT01003184|147430228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.06|||<|0.0001|TWO_SIDED|95.0|3.64|13.7|||Regression, Logistic|Logistic regression model includes the independent variables treatment group, use of SU (yes/no), baseline HbA1c and baseline weight.||||13.70|3.64|<.0001
73948622|NCT01003184|147430229|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.104||0.0001|TWO_SIDED|95.0|-0.62|-0.2|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-0.20|-0.62|0.0001
73977368|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.2|0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||0.2|-2.2|
73977369|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-2.4|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||0.4|-2.4|
73977370|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-2.3|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||0.6|-2.3|
73977371|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-3.0|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||0.0|-3.0|
73977372|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|95.0|-2.5|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||0.6|-2.5|
73977373|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.7|0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||0.5|-2.7|
73977374|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|-2.5|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||0.7|-2.5|
73977375|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-2.9|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||0.4|-2.9|
73977376|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-2.9|0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||0.5|-2.9|
73977377|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-3.2|0.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||0.1|-3.2|
73977378|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.4|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.0|-2.4|
73977379|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-2.5|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||1.1|-2.5|
73977380|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-2.5|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||1.1|-2.5|
73977381|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-2.7|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||1.0|-2.7|
73977382|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-2.5|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||1.2|-2.5|
73977383|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-2.5|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||1.2|-2.5|
73977384|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.8|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.1|-2.8|
73977385|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.5|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||1.4|-2.5|
73948623|NCT01003184|147430230|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|0.488|<|0.0001|TWO_SIDED|95.0|-4.63|-2.71|||Mixed Models Analysis|||Mixed model repeated measures MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-2.71|-4.63|<.0001
73948624|NCT01003184|147430231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0497|TWO_SIDED|95.0|1.0|3.18|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||3.18|1.00|0.0497
73948625|NCT01003184|147430232|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0074|TWO_SIDED|95.0|1.24|3.96|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||3.96|1.24|0.0074
73948626|NCT01003184|147430233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.89||||0.0002|TWO_SIDED|95.0|2.1|11.35|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||11.35|2.10|0.0002
73948627|NCT01003184|147430234|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.257||0.6993|TWO_SIDED|95.0|-0.41|0.61|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.61|-0.41|0.6993
73948628|NCT01003184|147430235|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.72|STANDARD_ERROR_OF_MEAN|1.853||0.0116|TWO_SIDED|95.0|-8.37|-1.07|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-1.07|-8.37|0.0116
73948629|NCT01003184|147430236|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|1.179||0.7034|TWO_SIDED|95.0|-2.77|1.88|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||1.88|-2.77|0.7034
73948630|NCT01003184|147430237|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.1061|TWO_SIDED|95.0|-0.32|0.03|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.03|-0.32|0.1061
73948631|NCT01003184|147430238|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.4638|TWO_SIDED|95.0|-0.05|0.02|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.02|-0.05|0.4638
73948632|NCT01003184|147430239|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.107||0.4967|TWO_SIDED|95.0|-0.14|0.28|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.28|-0.14|0.4967
73977386|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.1|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||1.8|-2.1|
73977387|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.9|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||1.1|-2.9|
73977388|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.6|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||1.3|-2.6|
73948633|NCT01003184|147430240|SUPERIORITY_OR_OTHER||Ratio|0.58|STANDARD_ERROR_OF_MEAN|0.322||0.3247|TWO_SIDED|95.0|0.19|1.72|||Poisson regression|||The number of episodes by patient were compared between treatment groups using a poisson model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.||1.72|0.19|0.3247
73948634|NCT02693834|147430242|OTHER|Paired t test||||||0.293|||||||t-test, 2 sided|||In order to test the difference in gait endurance,between the two AFO conditions at baseline, a paired t-test was analyzed||||.293
73948635|NCT02693834|147430243|OTHER|Repeated measures ANOVA||||||0.077||||||The above value was the interaction between the type of AFO and practice time.|repeated measures ANOVA|||A repeated measures ANOVA was calculated to find the differences in gait endurance between the type of AFO and practice time.||||0.077
73948636|NCT02693834|147430243|OTHER|Repeated measures ANOVA||||||0.046||||||main effect of the type of AFO: F(1, 19) = 4.58, ηp2= .194|repeated measures ANOVA|||The main effect of type of AFO||||.046
73948637|NCT02693834|147430243|OTHER|Repeated measures ANOVA|||||<|0.001||||||main effect of practice: F(1, 19) = 43.94, ηp2 = .698|repeated measures ANOVA|||Main effect of practice||||<.001
73948638|NCT02693834|147430244|OTHER|paired t test||||||0.688|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for self selected velocity||||.688
73948639|NCT02693834|147430244|OTHER|repeated measures MANOVA||||||0.397||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at the self selected velocity F(1, 19)= 0.75, ηp2 = .038|repeated measures MANOVA|||The significance of differences in gait symmetry at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.397
73948640|NCT02693834|147430244|OTHER|A repeated measures MANOVA||||||0.95||||||Main effect of AFO on gait symmetry at SSV: F(1, 19) = 0.004, ηp2 =.00|Repeated measures MANOVA|||Main effect of AFO on gait symmetry was analyzed at self selected velocity||||.950
73948641|NCT02693834|147430244|OTHER|Repeated measures MANOVA||||||0.111||||||The main effect of practice on gait symmetry at self selected velocity F(1, 19) = 2.79, ηp2 = .128|repeated measures MANOVA|||Main effect of practice on gait symmetry at Self selected velocity||||.111
73948642|NCT02693834|147430244|OTHER|||||||0.26|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for fast paced velocity||||.260
73948643|NCT02693834|147430244|OTHER|repeated measures MANOVA||||||0.113||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at fast paced velocity FPV F(1, 19) = 2.76,, ηp2 = .127|repeated measures MANOVA|||The significance of differences in gait symmetry at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA||||.113
74032281|NCT00051558|147617652|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
73948644|NCT02693834|147430244|OTHER|Repeated measures MANOVA||||||0.918||||||The main effect of AFO on gait symmetry at fast paced velocity: F(1, 19) = 0.01, ηp2 = 0.001|repeated measures MANOVA|||The main effect of AFO on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA||||.918
73948645|NCT02693834|147430244|OTHER|Repeated measures MANOVA||||||0.077||||||The main effect of practice on gait symmetry at fast paced velocity: F(1, 19) = 3.50, ηp2 = .155|repeated measures MANOVA|||The main effect of practice on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA||||.077
73948646|NCT02693834|147430245|OTHER|A repeated measures MANOVA||||||0.209||||||The above p value is for the interaction effects between the type of AFO and practice time at self selected velocity: F(1, 19) = 1.69, ηp2 = .082|Repeated measures MANOVA|||The significance of differences in gait velocity at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.209
73977389|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-2.4|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||1.6|-2.4|
73977390|NCT02434328|147501045|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||1.6|-2.5|
73977391|NCT02434328|147501046|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.4|0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||0.3|-2.4|
73977392|NCT02434328|147501046|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-2.4|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||0.7|-2.4|
73977393|NCT02434328|147501047|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.5|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48||0.4|-2.5|
73977394|NCT02434328|147501047|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.4|0.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.||Week 12 to Week 96|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|0.8|-2.4|
73977395|NCT02434328|147501048|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.5|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.4|-2.5|
74032282|NCT00051558|147617653|SUPERIORITY_OR_OTHER|||||||0.058||95.0||||P-value for Month 3|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.058
74032283|NCT00051558|147617653|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
73948647|NCT02693834|147430245|OTHER|Repeated measures MANOVA||||||0.32||||||Main effect of AFO on gait velocity at self selected velocity: F(1, 19) = 1.05, ηp2 = .05|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed at self selected velocity||||.32
73948648|NCT02693834|147430245|OTHER|Repeated measures MANOVA||||||0.001||||||Main effect of practice on gait velocity at self selected velocity:F(1, 19) = 14.38, ηp2 = .431|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed at self selected velocity||||.001
73948649|NCT02693834|147430245|OTHER|repeated measures MANOVA||||||0.28||||||The above p value is for the interaction effects between the type of AFO and practice time at fast paced velocity: F( 1, 19) = 1.24, ηp2 = .61|repeated measures MANOVA|||The significance of differences in gait velocity at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.280
73948650|NCT02693834|147430245|OTHER|repeated measures MANOVA||||||0.072||||||Main effect of AFO on gait velocity was analyzed at self selected velocity:FPV F(1, 19) = 3.63, ηp2 =.16|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed for self selected velocity||||.072
74032284|NCT00051558|147617653|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032285|NCT00051558|147617653|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032286|NCT00051558|147617653|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032287|NCT00051558|147617653|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032288|NCT00051558|147617654|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-value for 3 Months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.120
74032289|NCT00051558|147617654|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032290|NCT00051558|147617654|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032291|NCT00051558|147617654|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032292|NCT00051558|147617655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
74032293|NCT00051558|147617655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032294|NCT00051558|147617655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032295|NCT00051558|147617656|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36-month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.||||<0.001
74032296|NCT00051558|147617656|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032297|NCT00051558|147617656|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.002
74032298|NCT00051558|147617656|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.||||0.011
74032299|NCT00051558|147617656|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.015
74032300|NCT00051558|147617657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.||||<0.001
74032301|NCT00051558|147617657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032302|NCT00051558|147617657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
73948651|NCT02693834|147430245|OTHER|Repeated measures MANOVA|||||<|0.001||||||Main effect of Practice on gait velocity for fast paced velocity: F(1, 19) = 23.73, ηp2 = .555|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed for fast paced velocity||||<.001
73948652|NCT01107743|147430273|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.812|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between male and female in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.812
73948653|NCT01107743|147430274|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
73948654|NCT01107743|147430275|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension. The null hypothesis is there is no difference between with Hypetension and without Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
73977396|NCT02434328|147501049|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-5.1|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.9|-5.1|
73977397|NCT02434328|147501049|OTHER||Difference in proportions|-4.3|||||TWO_SIDED|95.0|-9.5|1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.0|-9.5|
73977398|NCT02434328|147501049|OTHER||Difference in proportions|-5.0|||||TWO_SIDED|95.0|-10.5|0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||0.3|-10.5|
73977399|NCT02434328|147501049|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-8.4|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.7|-8.4|
73977400|NCT02434328|147501049|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.8|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.8|-8.8|
73977401|NCT02434328|147501049|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.7|-5.2|
73977402|NCT02434328|147501049|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-9.9|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-9.9|
74032303|NCT00051558|147617657|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.||||0.006
73977403|NCT02434328|147501049|OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.5|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.7|-10.5|
74032304|NCT00051558|147617657|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.009
74032305|NCT00051558|147617658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
73948655|NCT01107743|147430276|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.112|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.112
73948656|NCT01107743|147430277|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.093|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Angina Pectoris. The null hypothesis is there is no difference between with Angina Pectoris and without Angina Pectoris in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.093
73948657|NCT01107743|147430278|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia. The null hypothesis is there is no difference between with Hypercholesterolemia and without Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
73948658|NCT01107743|147430279|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.839|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.839
73977404|NCT02434328|147501049|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-11.6|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.3|-11.6|
73977405|NCT02434328|147501049|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-11.5|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.9|-11.5|
73977406|NCT02434328|147501049|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.3|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||1.8|-11.3|
73977407|NCT02434328|147501049|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.1|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.8|-7.1|
73977408|NCT02434328|147501049|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.0|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.5|-7.0|
73977409|NCT02434328|147501049|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-7.7|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.4|-7.7|
74032306|NCT00051558|147617658|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.015
74032307|NCT00051558|147617658|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.002
74032308|NCT00051558|147617658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032309|NCT00051558|147617659|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.011
74032310|NCT00051558|147617659|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.009
74032311|NCT00051558|147617659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
73977410|NCT02434328|147501049|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.3|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-8.3|
73977411|NCT02434328|147501049|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.9|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-7.9|
74032312|NCT00051558|147617659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
74032313|NCT00051558|147617660|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74089286|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.15|||<|0.0001|TWO_SIDED|95.0|1.46|3.15|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.15|1.46|<.0001
73977412|NCT02434328|147501049|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-9.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.1|-9.9|
74032314|NCT00051558|147617660|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74032315|NCT00051558|147617660|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74032316|NCT00051558|147617660|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
73977413|NCT02434328|147501049|OTHER||Difference in proportions|-4.1|||||TWO_SIDED|95.0|-10.2|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.3|-10.2|
73977414|NCT02434328|147501049|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.0|-8.8|
73977415|NCT02434328|147501049|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-9.0|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.5|-9.0|
73977416|NCT02434328|147501049|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.9|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||2.8|-9.9|
73977417|NCT02434328|147501049|OTHER||Difference in proportions|-5.8|||||TWO_SIDED|95.0|-11.8|0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||0.3|-11.8|
73977418|NCT02434328|147501049|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-7.9|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.5|-7.9|
73977419|NCT02434328|147501049|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.1|-8.8|
73977420|NCT02434328|147501050|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.6|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.8|-7.6|
73977421|NCT02434328|147501050|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-13.0|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||0.1|-13.0|
73977422|NCT02434328|147501050|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.1|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-10.1|
73977423|NCT02434328|147501050|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-7.3|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.3|-7.3|
73977424|NCT02434328|147501050|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.2|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.2|-11.2|
73977425|NCT02434328|147501050|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-10.7|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.0|-10.7|
73977426|NCT02434328|147501050|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-9.6|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.0|-9.6|
73977427|NCT02434328|147501050|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-9.4|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.5|-9.4|
74032317|NCT00051558|147617661|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74032318|NCT00051558|147617661|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74032319|NCT00051558|147617661|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||0.004
73948659|NCT01107743|147430280|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Familial Hypercholesterolemia. The null hypothesis is there is no difference between with Familial Hypercholesterolemia and without Familial Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
73977428|NCT02434328|147501050|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-12.1|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.1|-12.1|
73977429|NCT02434328|147501050|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.9|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.5|-9.9|
73977430|NCT02434328|147501050|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-10.3|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-10.3|
73977431|NCT02434328|147501050|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-8.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||4.7|-8.7|
73977432|NCT02434328|147501050|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.7|-8.0|
73977433|NCT02434328|147501050|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-9.8|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.3|-9.8|
73977434|NCT02434328|147501050|OTHER|Hypothesis testing not pre-specified.|Difference in proportions|-2.8|||||TWO_SIDED|95.0|-9.6|4.2|||Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-9.6|
73977435|NCT02434328|147501050|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.8|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-8.8|
73977436|NCT02434328|147501050|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.4|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.0|-8.4|
73977437|NCT02434328|147501050|OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.4|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.9|-10.4|
73977438|NCT02434328|147501050|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.5|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.2|-6.5|
73977439|NCT02434328|147501050|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-7.5|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.1|-7.5|
73948660|NCT01107743|147430281|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with Hepatic Dysfunction and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
73948661|NCT01107743|147430282|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.644|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with Renal Dysfunction and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.644
74032320|NCT00051558|147617661|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||0.013
73948662|NCT01107743|147430283|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.155|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with Complications and without Complications in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.155
73948663|NCT01107743|147430284|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.305|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with Concomitant Drugs and without Concomitant Drugs in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.305
73948664|NCT01107743|147430285|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.234|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.234
73948665|NCT01107743|147430286|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.439|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.439
73948666|NCT01107743|147430287|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.761|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the participants of responders."||||=0.761
73948667|NCT01107743|147430288|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=1.000
73948668|NCT01107743|147430289|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.31|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.310
73948669|NCT01107743|147430290|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.251|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.251
73948670|NCT01107743|147430291|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.756|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=0.756
73948671|NCT01107743|147430292|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.706|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.706
73948672|NCT01107743|147430293|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.192|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.192
73948673|NCT01107743|147430294|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.005|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Angina Pectoris Severity. The null hypothesis is there is no difference among Class1, Class2, Class3, and Class4 in the participants of responders."||||=0.005
73948674|NCT01107743|147430295|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=1.000
73948675|NCT01107743|147430296|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.596|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.596
73977440|NCT02434328|147501050|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||3.1|-10.4|
73948676|NCT01107743|147430297|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.252|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.252
73948677|NCT01107743|147430298|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=1.000
73948678|NCT01107743|147430299|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.518|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.518
73948679|NCT01107743|147430300|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.645|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.645
73948680|NCT01107743|147430301|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.13|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the participants of responders."||||=0.130
73948681|NCT01107743|147430302|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.185|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=0.185
73948682|NCT01107743|147430303|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.714|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.714
73948683|NCT01107743|147430304|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.835|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.835
73948684|NCT01107743|147430305|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.252|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=0.252
73948685|NCT01396395|147430420|SUPERIORITY_OR_OTHER||Ratio|0.503|||<|0.0001|TWO_SIDED|95.0|0.435|0.581|||poisson regression: Non-calibration mode|||||0.581|0.435|<0.0001
73948686|NCT01396395|147430420|SUPERIORITY_OR_OTHER||Ratio|0.503|||=|0.0086|TWO_SIDED|95.0|0.301|0.84|||Poisson regression: Calibration model|||||0.840|0.301|=0.0086
73948687|NCT00882921|147430455|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.873||||0.1309|TWO_SIDED|95.0|0.731|11.296|||Negative Binomial Model|||The groups compared are Ab+ vs Ab-||11.296|0.731|0.1309
73948688|NCT00882921|147430455|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.082||||0.2718|TWO_SIDED|95.0|0.563|7.706|||Negative Binomial Model|||The groups compared are Ab+ (age adjusted) vs Ab- (age adjusted)||7.706|0.563|0.2718
73948689|NCT01370005|147430457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.72|-0.52||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.52|-0.72|<0.0001
74089287|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0024|TWO_SIDED|95.0|1.28|3.18|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.18|1.28|0.0024
74089288|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0011|TWO_SIDED|95.0|1.35|3.34|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.34|1.35|0.0011
73948690|NCT01370005|147430457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.75|-0.55||Hierarchical testing, no adjustment of p-values|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.55|-0.75|<0.0001
73948691|NCT01370005|147430458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|95.0|-4.78|-2.09||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-2.09|-4.78|<0.0001
73948692|NCT01370005|147430458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.16|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-5.5|-2.83||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-2.83|-5.50|<0.0001
73948693|NCT01370005|147430459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.4||0.0008|TWO_SIDED|95.0|-2.15|-0.56||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.56|-2.15|0.0008
73948694|NCT01370005|147430459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.51|-0.93||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.93|-2.51|<0.0001
73948695|NCT01370005|147430460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.26|||<|0.0001|TWO_SIDED|95.0|3.51|11.18|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||11.18|3.51|<0.0001
73948696|NCT01370005|147430460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.7|11.75|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||11.75|3.70|<0.0001
73977441|NCT02434328|147501050|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-9.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.9|-9.6|
73977442|NCT02434328|147501050|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.0|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.3|-5.0|
74089289|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0172|TWO_SIDED|95.0|1.14|3.72|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.14|0.0172
73948697|NCT01370005|147430461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.76|STANDARD_ERROR_OF_MEAN|2.63|<|0.0001|TWO_SIDED|95.0|-28.91|-18.6|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo.|||-18.60|-28.91|<0.0001
73948698|NCT01370005|147430461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-35.32|-25.08|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo.|||-25.08|-35.32|<0.0001
73948699|NCT01370005|147430462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.85|-1.13|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.|||-1.13|-1.85|<0.0001
73948700|NCT01370005|147430462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.33|-1.62|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.|||-1.62|-2.33|<0.0001
73948701|NCT01370005|147430463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-5.37|-2.52|||ANCOVA|Model includes treatment, baseline renal function, geographical region, N of antihypertensive medications, baseline HbA1c and baseline daytime SBP|Difference calculated as empa 10mg minus placebo.|||-2.52|-5.37|<0.0001
73948702|NCT01370005|147430463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.78|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-6.2|-3.36|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime SBP|Difference calculated as empa 25mg minus placebo.|||-3.36|-6.20|<0.0001
73948703|NCT01370005|147430464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.44||0.0004|TWO_SIDED|95.0|-2.42|-0.69|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 10mg minus placebo.|||-0.69|-2.42|0.0004
73948704|NCT01370005|147430464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.84|-1.12|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 25mg minus placebo.|||-1.12|-2.84|<0.0001
73948705|NCT01370005|147430465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.0021|TWO_SIDED|95.0|-4.09|-0.91|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 10mg minus placebo.|||-0.91|-4.09|0.0021
73948706|NCT01370005|147430465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.81||0.0003|TWO_SIDED|95.0|-4.48|-1.32|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 25mg minus placebo.|||-1.32|-4.48|0.0003
73977443|NCT02434328|147501050|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.0|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||6.8|-7.0|
73977444|NCT02434328|147501051|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-10.4|
74032321|NCT00051558|147617662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
73948707|NCT01370005|147430466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.5||0.0566|TWO_SIDED|95.0|-1.93|0.03|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 10mg minus placebo.|||0.03|-1.93|0.0566
73948708|NCT01370005|147430466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.5||0.0208|TWO_SIDED|95.0|-2.12|-0.18|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 25mg minus placebo.|||-0.18|-2.12|0.0208
73948709|NCT01370005|147430467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-5.86|-1.98|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 10mg minus placebo.|||-1.98|-5.86|<0.0001
73948710|NCT01370005|147430467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-6.73|-2.87|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 25mg minus placebo.|||-2.87|-6.73|<0.0001
73948711|NCT01370005|147430468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.55||0.0005|TWO_SIDED|95.0|-3.01|-0.84|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 10mg minus placebo.|||-0.84|-3.01|0.0005
73948712|NCT01370005|147430468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.55||0.0006|TWO_SIDED|95.0|-2.97|-0.82|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 25mg minus placebo.|||-0.82|-2.97|0.0006
73948713|NCT01370005|147430469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.0021|TWO_SIDED|95.0|1.39|4.45|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||4.45|1.39|0.0021
73948714|NCT01370005|147430469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0088|TWO_SIDED|95.0|1.22|3.96|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||3.96|1.22|0.0088
73870577|NCT00250276|147285059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.26|||||TWO_SIDED|95.0|0.98|1.63|||ANOVA|The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.63|0.98|
73870578|NCT00250276|147285059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.48|||||TWO_SIDED|95.0|1.18|1.85|||ANOVA|The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.85|1.18|
73870579|NCT00250276|147285059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-16 antibodies.|GMT ratio for anti-HPV-16 antibody|1.21|||||TWO_SIDED|95.0|0.94|1.55|||ANOVA|The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.55|0.94|
73870580|NCT00250276|147285059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.24|||||TWO_SIDED|95.0|1.0|1.55|||ANOVA|The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.55|1.00|
73948715|NCT00856661|147430482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.229|TWO_SIDED|95.0|0.79|2.64|||Regression, Logistic|If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if alive, or 6, if otherwise = death||All patients who were treated and had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included.||2.64|0.79|0.2290
73948716|NCT00856661|147430483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9401|TWO_SIDED|95.0|0.59|1.62|||Regression, Logistic|||||1.62|0.59|0.9401
73948717|NCT00856661|147430484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.5076|TWO_SIDED|95.0|0.68|2.18|||Regression, Logistic|||All patients treated, who had at least one valid post-baseline assessment of the mRS and with a baseline NIHSS score of 8 to 24. If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if the patient was known to be alive, or 6, if otherwise = dead.||2.18|0.68|0.5076
73948718|NCT00856661|147430485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.6146|TWO_SIDED|95.0|0.72|1.75|||Regression, Logistic|||all patients treated, who had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included||1.75|0.72|0.6146
73977445|NCT02434328|147501051|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-10.2|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.7|-10.2|
73977446|NCT02434328|147501051|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-10.7|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.3|-10.7|
74032322|NCT00051558|147617662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
73870581|NCT00250276|147285059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-16 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||TWO_SIDED|95.0|-3.63|1.02|||Proc StatXact 5.0|||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, one month after the third dose (Month 7).||1.02|-3.63|
73870582|NCT00250276|147285059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-18 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||TWO_SIDED|95.0|-3.18|0.94|||Proc StatXact 5.0|||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||0.94|-3.18|
73948719|NCT02120664|147430487|SUPERIORITY_OR_OTHER||R squared|0.907|||||TWO_SIDED||||||Regression, Linear|||||||
73948720|NCT02120664|147430488|SUPERIORITY_OR_OTHER||Coefficient of Variation|2.53|||||TWO_SIDED|||||||||||||
73948721|NCT02120664|147430488|SUPERIORITY_OR_OTHER||Coefficient of Variation|6.69|||||TWO_SIDED|||||||||||||
73948722|NCT04524598|147430513|SUPERIORITY||t|-1.911||||0.06|TWO_SIDED||||||Mixed Models Analysis|||A linear mixed-effects model (LMM) analysis was implemented on an averaged imputed dataset to evaluate main effects of Group (Spark, Control) and Week (0-5), and the Group x Week interaction. Group and Week were entered as fixed factors. Spark version, and assessment completion days since baseline were included as fixed factors to control for effects of app version and differences in time between completion of successive weekly assessments.||||0.06
73977447|NCT02434328|147501051|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-8.4|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||5.7|-8.4|
73977448|NCT02434328|147501051|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-12.3|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||1.5|-12.3|
73977449|NCT02434328|147501051|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-9.9|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.7|-9.9|
73977450|NCT02434328|147501051|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-12.8|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||0.7|-12.8|
73977451|NCT02434328|147501051|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-8.2|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.8|-8.2|
73977452|NCT02434328|147501051|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-9.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.2|-9.2|
73977453|NCT02434328|147501051|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-8.2|
73977454|NCT02434328|147501051|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-8.5|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.0|-8.5|
73977455|NCT02434328|147501051|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-7.4|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.2|-7.4|
73977456|NCT02434328|147501051|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.8|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.0|-9.8|
73977457|NCT02434328|147501051|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.6|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.8|-8.6|
73977458|NCT02434328|147501051|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-7.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.1|-7.8|
73977459|NCT02434328|147501051|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.5|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||9.2|-4.5|
73977460|NCT02434328|147501051|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-8.6|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.9|-8.6|
73977461|NCT02434328|147501051|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-5.8|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||7.5|-5.8|
73977462|NCT02434328|147501051|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-5.1|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.4|-5.1|
73977463|NCT02434328|147501051|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-2.8|10.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||10.9|-2.8|
73977464|NCT02434328|147501051|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.3|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.1|-9.3|
73977465|NCT02434328|147501051|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-6.1|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||7.7|-6.1|
73948723|NCT04524598|147430513|SUPERIORITY||t|-2.546||||0.01|TWO_SIDED||||||Mixed Models Analysis|||We used a Per Protocol approach that included participants who completed the PHQ at baseline and each week. A linear mixed-effects model (LMM) analysis was implemented on an averaged imputed dataset to evaluate main effects of Group (Spark, Control) and Week (0-5), and the Group x Week interaction.||||0.01
73948724|NCT04524598|147430516|SUPERIORITY||F|1.46||||0.23|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on GAD-7 scores to compare the change in anxiety symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is presented.||||0.23
73948725|NCT04524598|147430516|SUPERIORITY||F|2.59||||0.11|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on the PROMIS - General Health Score to compare the change in general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is reported.||||0.11
73948726|NCT04524598|147430517|SUPERIORITY||F|0.94||||0.33|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Time x Group) on the MFQ to compare the change in parent report of depressive symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is presented.||||0.33
73948727|NCT04524598|147430517|SUPERIORITY||F|0.02||||0.9|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on the PROMIS Parent Proxy - General Health Score to compare the change in parent reported general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is reported.||||0.90
73948728|NCT02301156|147430521|SUPERIORITY|||||||0.0463|||||||Cochran-Mantel-Haenszel|P-value was estimated by Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata prior lines of therapy.||||||0.0463
73948729|NCT02301156|147430522|SUPERIORITY|||||||0.0159|||||||Cochran-Mantel-Haenszel|P-value was estimated by CMH test stratified by the randomization strata prior lines of therapy.||||||0.0159
73948730|NCT02301156|147430523|SUPERIORITY||Rate Difference|35.64|||<|0.0001|TWO_SIDED|95.0|21.39|49.88|||Cochran-Mantel-Haenszel|P-value was estimated using CMH test stratified by the randomization strata prior lines of therapy.|95% Confidence Interval (CI) was estimated using Clopper-Pearson method based on the binomial distribution.|||49.88|21.39|<0.0001
73948731|NCT02301156|147430524|SUPERIORITY||Hazard Ratio (HR)|0.573||||0.0961|TWO_SIDED|95.0|0.295|1.113|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||1.113|0.295|0.0961
73948732|NCT02301156|147430525|SUPERIORITY||Hazard Ratio (HR)|0.569||||0.1486|TWO_SIDED|95.0|0.263|1.234|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||1.234|0.263|0.1486
73948733|NCT02301156|147430526|SUPERIORITY||Hazard Ratio (HR)|2.163||||0.0004|TWO_SIDED|95.0|1.399|3.344|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||3.344|1.399|0.0004
73948734|NCT02090634|147430553|SUPERIORITY|||||||0.95||||||Cliff's d = 0.01; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to ARV medications.||||0.95
73948735|NCT02090634|147430553|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Cliff's d = -0.13; calculated to estimate the effect size for between-group comparisons with non-parametric data||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to PSY medications.||||0.43
73948736|NCT02090634|147430554|SUPERIORITY|||||||0.02||||||Cliff's d = 0.37; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for ARV medications.||||0.02
73948737|NCT02090634|147430554|SUPERIORITY|||||||0.42||||||Cliff's d = 0.14; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for PSY medications.||||0.42
73948738|NCT03757234|147430558|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.6|||||TWO_SIDED|95.0|-12.4|6.9|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||6.9|-12.4|
73948739|NCT03757234|147430558|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.9|||||TWO_SIDED|95.0|-34.8|5.3|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||5.3|-34.8|
73948740|NCT03757234|147430558|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.0|||||TWO_SIDED|95.0|-30.6|8.2|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||8.2|-30.6|
73948741|NCT03757234|147430558|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment Difference|0.9|||||TWO_SIDED|95.0|-22.4|11.8|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||11.8|-22.4|
73948742|NCT03757234|147430559|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.4|||||TWO_SIDED|95.0|-23.6|12.7|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||12.7|-23.6|
73948743|NCT03757234|147430559|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-47.7|||||TWO_SIDED|95.0|-71.3|-6.0|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||-6.0|-71.3|
73948744|NCT03757234|147430559|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-10.7|||||TWO_SIDED|95.0|-40.8|15.1|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||15.1|-40.8|
73948745|NCT03757234|147430559|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-36.5|||||TWO_SIDED|95.0|-62.6|-1.1|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||-1.1|-62.6|
73948746|NCT01871558|147430581|SUPERIORITY_OR_OTHER|||||||0.139|||||||Chi-squared|||||||0.139
73948747|NCT01103960|147430594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1881|STANDARD_ERROR_OF_MEAN|0.803||0.007||95.0|0.6082|3.7681||This was the first step in the closed testing procedure of multiple endpoints. The p-value was \<0.05 so this test was considered confirmatory. Proceeding to the next step was allowed, testing the same endpoint in the subgroup of Chinese patients.|ANCOVA|||A5 minus T80/A5||3.7681|0.6082|0.007
73948748|NCT01103960|147430595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9195|STANDARD_ERROR_OF_MEAN|0.9015||0.034||95.0|0.1443|3.6947||This was the second step in the closed testing procedure of multiple endpoints. The p-value was again \<0.05 so this test was also considered confirmatory.|ANCOVA|||A5 minus T80/A5||3.6947|0.1443|0.034
73948749|NCT01103960|147430596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4879|STANDARD_ERROR_OF_MEAN|1.1217|<|0.001||95.0|2.2807|6.695|||ANCOVA|||A5 minus T80/A5||6.6950|2.2807|<0.001
73948750|NCT02708433|147430606|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|49.0||0.74|TWO_SIDED|95.0|-0.49|0.57|||Wilcoxon (Mann-Whitney)|||||0.57|-0.49|0.74
73948751|NCT02708433|147430607|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|48.0||0.5|TWO_SIDED|95.0|-0.89|0.52|||Wilcoxon (Mann-Whitney)|||||0.52|-0.89|0.5
73948752|NCT01158378|147430639|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%||||||0.0049|||||||one-sided z-test|||||||0.0049
73977466|NCT02434328|147501051|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-3.0|10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||10.4|-3.0|
73977467|NCT02434328|147501051|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-3.9|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||10.0|-3.9|
74032323|NCT00051558|147617662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
73948753|NCT01158378|147430640|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test|||||||<0.0001
73948754|NCT01158378|147430640|SUPERIORITY_OR_OTHER|||||||0.0297|||||||one-sided z-test|||Superiority Test||||0.0297
73948755|NCT01158378|147430641|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test|||||||<0.0001
73948756|NCT01158378|147430641|SUPERIORITY_OR_OTHER|||||||0.0561|||||||one-sided z-test|||Superiority Test||||0.0561
73948757|NCT03017235|147430643|NON_INFERIORITY|The NI margin for the difference between treatments (NaP/MC Oral Solution minus PREPOPIK) was pre-specified at -8% (absolute). If NI was demonstrated for both the primary efficacy endpoint and the secondary efficacy endpoint for the right colon, and if the lower bound of the CI was above 0%, then superiority was declared for the primary endpoint. Thus, the pre-specified superiority analysis was conducted at a one-sided significance level of 2.5%.|Difference in percentage|6.3||||0.0067|TWO_SIDED|95.0|1.8|10.9||The above p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)|Lower limit of 95% CI \> 0% for the primary efficacy endpoint combined with outcome of secondary efficacy endpoint for the right colon allowed for superiority analysis.|10.9|1.8|0.0067
73948758|NCT03017235|147430644|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|4.6||||0.0099|TWO_SIDED|95.0|1.1|8.0||The p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)||8.0|1.1|0.0099
73948759|NCT03017235|147430645|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|1.9||||0.1781|TWO_SIDED|95.0|-0.9|4.7||The above p-value was tested for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran Mantel Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC - PREPOPIK)||4.7|-0.9|0.1781
74032324|NCT00051558|147617662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74032325|NCT00051558|147617663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
73948760|NCT03017235|147430646|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to colon cleansing in preparation for colonoscopy.|Difference in percentage|3.5||||0.0391|TWO_SIDED|95.0|0.2|6.7||The above p-value was for superiority and was based on the stratified percentage difference, where the stratification weight is based on Cochran-Mantel-Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC-PREPOPIK®)||6.7|0.2|0.0391
74032326|NCT00051558|147617663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74032327|NCT00051558|147617663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
73948761|NCT02105636|147430684|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0101|TWO_SIDED|95.0|0.53|0.92||Log-rank Test stratified by prior treatment with cetuximab (yes, no) as entered into the Interactive Voice Response System (IVRS). For OS the boundary for statistical significance requires the p-value to be less than 0.0227.|Log Rank||Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm.|Stratified Cox proportional hazard model. HR = Nivolumab over investigator's choice therapy (Cetuximab, Methotrexate, or Docetaxel)||0.92|0.53|0.0101
73948762|NCT02105636|147430685|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.68|1.1|||||Number of responders (CR +PR) over number of participants|||1.10|0.68|
73948763|NCT02105636|147430686|SUPERIORITY||Difference in ORR|7.6|||||TWO_SIDED|95.0|1.5|13.6|||||Stratum adjusted difference in response rates (Nivolumab - Investigators Choice) based on the Cochran-Mantel-Haenszel method of weighting.|||13.6|1.5|
73948764|NCT02105636|147430686|SUPERIORITY||CMH Estimate of Common Odds Ratio|2.49|||||TWO_SIDED|95.0|1.07|5.82|||||Stratified by Prior Cetuximab (yes, no) as recorded in the IVRS. Stratum adjusted odds ratio (Nivolumab - Investigators Choice) using Mantel-Haenszel Method.|||5.82|1.07|
73948765|NCT02105636|147430687|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.54|0.85|||||Stratified Cox proportional hazards model. Hazard ratio of nivolumab to investigator's choice therapy.|||0.85|0.54|
73948766|NCT03029247|147430708|SUPERIORITY||LS Mean Difference|-0.17||||0.9694|TWO_SIDED|95.0|-8.8|8.47||p-value for the difference between treatment groups were presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% confidence interval (CI) has been presented.|||8.47|-8.80|0.9694
73948767|NCT03029247|147430709|SUPERIORITY||LS Mean Difference|-1.32||||0.7745|TWO_SIDED|95.0|-10.46|7.83||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of SBP and its corresponding 95% CI has been presented.|||7.83|-10.46|0.7745
73948768|NCT03029247|147430709|SUPERIORITY||LS Mean Difference|-1.95||||0.291|TWO_SIDED|95.0|-5.62|1.71||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of DBP and its corresponding 95% CI has been presented.|||1.71|-5.62|0.2910
73948769|NCT03029247|147430709|SUPERIORITY||LS Mean Difference|-2.4||||0.4611|TWO_SIDED|95.0|-8.88|4.07||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of MAP and its corresponding 95% CI has been presented.|||4.07|-8.88|0.4611
74032328|NCT00051558|147617663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74032329|NCT00051558|147617664|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74032330|NCT00051558|147617664|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74032331|NCT00051558|147617664|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74032332|NCT00051558|147617664|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
74032333|NCT00051558|147617665|SUPERIORITY_OR_OTHER|||||||0.212||95.0||||p-value for Any Fracture|Cochran-Mantel-Haenszel|||||||0.212
73948770|NCT03029247|147430710|SUPERIORITY||LS Mean Difference|-2.95||||0.1648|TWO_SIDED|95.0|-7.14|1.24||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% CI has been presented.|||1.24|-7.14|0.1648
73948771|NCT03029247|147430711|SUPERIORITY||LS Mean Difference|-13.42||||0.9142|TWO_SIDED|95.0|-261.75|234.92||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of SBP and its corresponding 95% CI has been presented.|||234.92|-261.75|0.9142
73948772|NCT03029247|147430711|SUPERIORITY||LS Mean Difference|-71.7||||0.2266|TWO_SIDED|95.0|-189.21|45.8||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of DBP and its corresponding 95% CI has been presented.|||45.80|-189.21|0.2266
73948773|NCT03029247|147430711|SUPERIORITY||LS Mean Difference|-54.24||||0.5246|TWO_SIDED|95.0|-223.99|115.51||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of MAP and its corresponding 95% CI has been presented.|||115.51|-223.99|0.5246
73948774|NCT03029247|147430712|SUPERIORITY||LS Mean Difference|-74.4||||0.1563|TWO_SIDED|95.0|-178.15|29.34||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of HR and its corresponding 95% CI has been presented.|||29.34|-178.15|0.1563
73870583|NCT00250276|147285059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates for anti-HPV-16 was below 2%.|GMC ratio for anti-HPV-16 antibody|0.87|||||TWO_SIDED|95.0|0.7|1.08|||ANOVA|The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||1.08|0.70|
74032334|NCT00051558|147617665|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||p-value for Nonvertebral Fracture|Cochran-Mantel-Haenszel|||||||0.843
73948775|NCT03029247|147430713|SUPERIORITY||LS Mean Difference|-2.06||||0.3247|TWO_SIDED|95.0|-6.23|2.1||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of DBP and its corresponding 95% CI has been presented.|||2.10|-6.23|0.3247
73948776|NCT03029247|147430713|SUPERIORITY||LS Mean Difference|-2.51||||0.4235|TWO_SIDED|95.0|-8.76|3.74||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of MAP and its corresponding 95% CI has been presented.|||3.74|-8.76|0.4235
73977468|NCT02434328|147501052|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.6|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.4|-1.6|
73977469|NCT02434328|147501052|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-2.3|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.1|-2.3|
73977470|NCT02434328|147501052|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.9|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2 mg) was estimated using a bootstrap method.|Week 12||2.2|-1.9|
73977471|NCT02434328|147501052|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.1|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.3|-2.1|
73977472|NCT02434328|147501052|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-2.0|
73977473|NCT02434328|147501052|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.0|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||2.2|-3.0|
73977474|NCT02434328|147501052|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.0|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-3.0|
73977475|NCT02434328|147501052|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.2|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.5|-3.2|
73977476|NCT02434328|147501052|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-2.3|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.3|-2.3|
73977477|NCT02434328|147501052|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-1.7|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.6|-1.7|
73977478|NCT02434328|147501052|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-2.7|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.4|-2.7|
73977479|NCT02434328|147501052|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.9|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.2|-3.9|
73977480|NCT02434328|147501052|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-4.3|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||2.3|-4.3|
73977481|NCT02434328|147501052|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.8|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.9|-2.8|
74032335|NCT00051558|147617665|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value for Vertebral Fracture|Cochran-Mantel-Haenszel|||||||0.007
73948777|NCT03029247|147430714|SUPERIORITY||LS Mean Difference|-0.13||||0.9353|TWO_SIDED|95.0|-3.41|3.14||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% CI has been presented.|||3.14|-3.41|0.9353
73977482|NCT02434328|147501052|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.5|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-2.5|
73977483|NCT02434328|147501052|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-2.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||4.5|-2.7|
73948778|NCT03029247|147430715|SUPERIORITY||LS Mean Difference|-144.97||||0.2573|TWO_SIDED|95.0|-399.71|109.76||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of SBP and its corresponding 95% CI has been presented.|||109.76|-399.71|0.2573
73948779|NCT03029247|147430715|SUPERIORITY||LS Mean Difference|-117.49||||0.045|TWO_SIDED|95.0|-232.26|-2.72||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of DBP and its corresponding 95% CI has been presented.|||-2.72|-232.26|0.0450
73948780|NCT03029247|147430715|SUPERIORITY||LS Mean Difference|-131.94||||0.1341|TWO_SIDED|95.0|-306.24|42.36||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of MAP and its corresponding 95% CI has been presented.|||42.36|-306.24|0.1341
73948781|NCT03029247|147430716|SUPERIORITY||LS Mean Difference|-97.67||||0.1119|TWO_SIDED|95.0|-219.05|23.71||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of HR and its corresponding 95% CI has been presented.|||23.71|-219.05|0.1119
73948782|NCT01976364|147430770|OTHER||Least Squares (LS) Mean difference|0.0255|||||TWO_SIDED|95.0|-0.0513|0.1022||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Analysis was based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1022|-0.0513|
73948783|NCT01976364|147430771|OTHER||LS mean difference|0.091|||||TWO_SIDED|95.0|-0.131|0.313||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.313|-0.131|
73948784|NCT01976364|147430805|OTHER||LS Mean Difference|0.0486|||||TWO_SIDED|95.0|-0.0192|0.1163||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1163|-0.0192|
73977484|NCT02434328|147501052|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-4.2|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||2.6|-4.2|
73977485|NCT02434328|147501052|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.5|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.5|-2.5|
73977486|NCT02434328|147501052|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-2.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.4|-2.5|
73977487|NCT02434328|147501052|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.4|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||4.6|-2.4|
73948785|NCT01976364|147430805|OTHER||LS Mean Difference|0.0325|||||TWO_SIDED|95.0|-0.0372|0.1021||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1021|-0.0372|
73948786|NCT01976364|147430805|OTHER||LS Mean Difference|-0.0058|||||TWO_SIDED|95.0|-0.0941|0.0825||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0825|-0.0941|
73948787|NCT01976364|147430805|OTHER||LS Mean Difference|0.0096|||||TWO_SIDED|95.0|-0.0734|0.0927||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0927|-0.0734|
73948788|NCT01976364|147430806|OTHER||LS Mean Difference|0.032|||||TWO_SIDED|95.0|-0.163|0.227||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.227|-0.163|
73948789|NCT01976364|147430806|OTHER||LS Mean Difference|-0.024|||||TWO_SIDED|95.0|-0.266|0.219||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.219|-0.266|
74032336|NCT00051558|147617665|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||p-value for Clinical Vertebral Fracture|Cochran-Mantel-Haenszel|||||||0.037
73948790|NCT01976364|147430806|OTHER||LS Mean Difference|0.213|||||TWO_SIDED|95.0|-0.045|0.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.470|-0.045|
73948791|NCT01976364|147430806|OTHER||LS Mean Difference|-0.061|||||TWO_SIDED|95.0|-0.309|0.188||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.188|-0.309|
73948792|NCT01976364|147430807|OTHER||Difference in percentage of participants|-0.14|||||TWO_SIDED|95.0|-9.76|9.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||9.48|-9.76|
73977488|NCT02434328|147501052|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-3.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.1|-3.1|
73977489|NCT02434328|147501052|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-3.5|
73977490|NCT02434328|147501052|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.8|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.3|-3.8|
73977491|NCT02434328|147501052|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.8|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||3.3|-3.8|
73977492|NCT02434328|147501053|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-2.6|1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.6|-2.6|
73977493|NCT02434328|147501053|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.2|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.1|-2.2|
73977494|NCT02434328|147501053|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-2.8|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-2.8|
74032337|NCT00051558|147617665|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||p-value for Nonvertebral Fragility Fracture|Cochran-Mantel-Haenszel|||||||0.256
74032338|NCT01808118|147617675|OTHER||||||<|0.001||||||2-sided Pearson's chi-square test|Chi-squared|||||||<0.001
73977495|NCT02434328|147501053|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-4.4|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||1.7|-4.4|
73977496|NCT02434328|147501053|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-1.7|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.9|-1.7|
74032339|NCT01808118|147617694|OTHER||||||<|0.001|||||||Log Rank|||The statistical test was performed at a 2-sided significance level of 0.05. Time to flare analysis showed statistically significant lower risk of flare in the adalimumab group than in the placebo group.||||<0.001
74032340|NCT00365716|147617733|SUPERIORITY_OR_OTHER||Vaccine Efficacy|89.5||||||95.0|70.7|97.3|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||97.3|70.7|
74032341|NCT05761444|147617734|OTHER||Least Squares (LS) mean difference|-21.22|||<|0.0001|TWO_SIDED|95.0|-29.26|-13.19||The analysis of covariance (ANCOVA) model with treatment group (ezetimibe/atorvastatin, atorvastatin) and history of statin administration (yes, no) as fixed effects and baseline LDL-C as a covariate.|ANCOVA|||||-13.19|-29.26|<0.0001
74032342|NCT05761444|147617737|OTHER||LS mean difference|-15.96|||<|0.0001|TWO_SIDED|95.0|-23.56|-8.36||The ANCOVA model with treatment group (ezetimibe/atorvastatin, atorvastatin) and history of statin administration (yes, no) as fixed effects and baseline LDL-C as a covariate.|ANCOVA|||||-8.36|-23.56|<0.0001
74032343|NCT00069576|147617756|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.14|TWO_SIDED|97.0|0.72|1.07|||Chi-squared|||For Total Composite End Point||1.07|0.72|0.14
74032344|NCT00069576|147617756|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.75|TWO_SIDED|97.0|0.73|1.53|||Chi-squared|||Analysis for Hypoglycemia||1.53|0.73|0.75
73948793|NCT01976364|147430807|OTHER||Difference in percentage of participants|-4.57|||||TWO_SIDED|95.0|-12.91|3.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||3.77|-12.91|
73948794|NCT01976364|147430807|OTHER||Difference in percentage of participants|-5.69|||||TWO_SIDED|95.0|-14.26|2.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||2.87|-14.26|
73948795|NCT01976364|147430807|OTHER||Difference in percentage of participants|-2.36|||||TWO_SIDED|95.0|-11.59|6.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||6.87|-11.59|
73948796|NCT01976364|147430807|OTHER||Difference in percentage of participants|-10.15|||||TWO_SIDED|95.0|-18.16|-2.14||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||-2.14|-18.16|
73948797|NCT01976364|147430808|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.1|
73948798|NCT01976364|147430808|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-0.1|
73948799|NCT01976364|147430808|OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.0|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|0.0|
73948800|NCT01976364|147430808|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|0.1|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|0.1|
73948801|NCT01976364|147430808|OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-0.1|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-0.1|
73948802|NCT01976364|147430809|OTHER||LS mean difference|-19.43|||||TWO_SIDED|95.0|-58.06|19.21||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||19.21|-58.06|
73948803|NCT01976364|147430809|OTHER||LS mean difference|-30.11|||||TWO_SIDED|95.0|-83.58|23.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||23.37|-83.58|
73948804|NCT01976364|147430809|OTHER||LS mean difference|-24.33|||||TWO_SIDED|95.0|-83.35|34.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||34.69|-83.35|
73948805|NCT01976364|147430809|OTHER||LS mean difference|-11.64|||||TWO_SIDED|95.0|-60.87|37.58||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||37.58|-60.87|
73948806|NCT01976364|147430809|OTHER||LS mean difference|7.02|||||TWO_SIDED|95.0|-49.73|63.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||63.77|-49.73|
73977497|NCT02434328|147501053|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.9|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||2.8|-3.9|
73948807|NCT01976364|147430811|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
73948808|NCT01976364|147430811|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
73948809|NCT01976364|147430811|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
73948810|NCT01976364|147430811|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
73948811|NCT01976364|147430811|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
73948812|NCT01976364|147430812|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.9|
73948813|NCT01976364|147430812|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.9|
73977498|NCT02434328|147501053|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.2|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.8|-3.2|
73948814|NCT01976364|147430812|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-1.1|
73948815|NCT01976364|147430812|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.6|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.1|-0.6|
73948816|NCT01976364|147430812|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.6|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-0.6|
73977499|NCT02434328|147501053|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-3.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.5|-3.8|
73977500|NCT02434328|147501053|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.0|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.2|-3.0|
73977501|NCT02434328|147501053|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.1|-2.4|
73977502|NCT02434328|147501053|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-1.1|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.5|-1.1|
73977503|NCT02434328|147501053|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-4.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.3|-4.0|
73977504|NCT02434328|147501053|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.8|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.7|-2.8|
73977505|NCT02434328|147501053|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.8|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.5|-2.8|
73977506|NCT02434328|147501053|OTHER||Difference of proportions|1.0|||||TWO_SIDED|95.0|-2.6|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.7|-2.6|
73977507|NCT02434328|147501053|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.0|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||4.3|-4.0|
73948817|NCT01976364|147430814|OTHER||Difference in percentage of participants|11.67|||||TWO_SIDED|95.0|-15.65|38.98||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||38.98|-15.65|
73948818|NCT01976364|147430814|OTHER||Difference in percentage of participants|30.42|||||TWO_SIDED|95.0|0.64|60.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||60.20|0.64|
73977508|NCT02434328|147501053|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.2|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.6|-4.2|
73977509|NCT02434328|147501053|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.0|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||3.7|-4.0|
73977510|NCT02434328|147501053|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-3.5|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.7|-3.5|
73977511|NCT02434328|147501053|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-4.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.4|-4.5|
73977512|NCT02434328|147501053|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-3.6|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.5|-3.6|
73870584|NCT00250276|147285059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates anti-HPV-18 antibodies was below 2%.|GMC ratio for anti-HPV-18 antibody|0.8|||||TWO_SIDED|95.0|0.66|0.97|||ANOVA|The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||0.97|0.66|
73948819|NCT01976364|147430814|OTHER||Difference in percentage of participants|29.58|||||TWO_SIDED|95.0|-3.46|62.62||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||62.62|-3.46|
73948820|NCT01976364|147430814|OTHER||Difference in percentage of participants|24.17|||||TWO_SIDED|95.0|-5.14|53.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||53.47|-5.14|
73948821|NCT01976364|147430814|OTHER||Difference in percentage of participants|17.08|||||TWO_SIDED|95.0|-15.96|50.12||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||50.12|-15.96|
73948822|NCT01976364|147430815|OTHER||Difference in percentage of participants|4.99|||||TWO_SIDED|95.0|-9.61|19.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||19.60|-9.61|
73948823|NCT01976364|147430815|OTHER||Difference in percentage of participants|3.88|||||TWO_SIDED|95.0|-10.74|18.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||18.50|-10.74|
73948824|NCT01976364|147430815|OTHER||Difference in percentage of participants|2.82|||||TWO_SIDED|95.0|-11.8|17.45||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||17.45|-11.80|
73948825|NCT01976364|147430815|OTHER||Difference in percentage of participants|3.97|||||TWO_SIDED|95.0|-10.58|18.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||18.52|-10.58|
73948826|NCT01976364|147430815|OTHER||Difference in percentage of participants|2.87|||||TWO_SIDED|95.0|-11.63|17.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||17.37|-11.63|
73977513|NCT02434328|147501053|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-4.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-4.5|
73977514|NCT02434328|147501053|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-5.7|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||2.6|-5.7|
73870585|NCT01153724|147285100|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|113.29|STANDARD_DEVIATION|13.6||0.0101|TWO_SIDED|90.0|105.893|121.197||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol||121.197|105.893|0.0101
73948827|NCT01976364|147430816|OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-1.5|
73948828|NCT01976364|147430816|OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.6|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-1.6|
73948829|NCT01976364|147430816|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-1.0|
73948830|NCT01976364|147430816|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.9|-0.9|
73948831|NCT01976364|147430816|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.1|-0.7|
73948832|NCT01976364|147430817|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.3|
73948833|NCT01976364|147430817|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.6|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-0.6|
73948834|NCT01976364|147430817|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.4|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.4|
74032345|NCT00069576|147617756|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.74||||0.12|TWO_SIDED|97.0|0.49|1.12|||Chi-squared|||Analysis for hyperbilirubinemia||1.12|0.49|0.12
73948835|NCT01976364|147430817|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.3|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-0.3|
73948836|NCT01976364|147430817|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.3|-0.5|
74032346|NCT00069576|147617756|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.07|TWO_SIDED|97.0|0.57|1.05|||Chi-squared|||Analysis for elevated cord-blood C-peptide level||1.05|0.57|0.07
73948837|NCT01976364|147430818|OTHER||LS mean difference|0.26|||||TWO_SIDED|95.0|-2.51|3.02||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.02|-2.51|
73948838|NCT01976364|147430818|OTHER||LS mean difference|0.77|||||TWO_SIDED|95.0|-2.64|4.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||4.18|-2.64|
73948839|NCT01976364|147430818|OTHER||LS mean difference|0.47|||||TWO_SIDED|95.0|-2.26|3.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.20|-2.26|
73948840|NCT01976364|147430818|OTHER||LS mean difference|2.18|||||TWO_SIDED|95.0|-1.46|5.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.81|-1.46|
73948841|NCT01976364|147430818|OTHER||LS mean difference|-0.12|||||TWO_SIDED|95.0|-3.25|3.01||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.01|-3.25|
73948842|NCT01976364|147430819|OTHER||LS mean difference|-2.03|||||TWO_SIDED|95.0|-5.58|1.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.52|-5.58|
73948843|NCT01976364|147430819|OTHER||LS mean difference|-0.43|||||TWO_SIDED|95.0|-4.69|3.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.84|-4.69|
73977515|NCT02434328|147501053|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-4.9|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||3.2|-4.9|
73977516|NCT02434328|147501054|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-3.5|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.5|-3.5|
73948844|NCT01976364|147430819|OTHER||LS mean difference|1.29|||||TWO_SIDED|95.0|-3.48|6.06||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||6.06|-3.48|
73948845|NCT01976364|147430819|OTHER||LS mean difference|0.64|||||TWO_SIDED|95.0|-4.03|5.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.32|-4.03|
73948846|NCT01976364|147430819|OTHER||LS mean difference|-0.13|||||TWO_SIDED|95.0|-4.64|4.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||4.38|-4.64|
73948847|NCT01976364|147430820|OTHER||LS mean difference|-1.11|||||TWO_SIDED|95.0|-4.96|2.74||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.74|-4.96|
73948848|NCT01976364|147430820|OTHER||LS mean difference|-1.23|||||TWO_SIDED|95.0|-5.11|2.65||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.65|-5.11|
73948849|NCT01976364|147430820|OTHER||LS mean difference|0.95|||||TWO_SIDED|95.0|-3.78|5.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.69|-3.78|
73948850|NCT01976364|147430820|OTHER||LS mean difference|2.01|||||TWO_SIDED|95.0|-2.92|6.93||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||6.93|-2.92|
73977517|NCT02434328|147501054|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-4.4|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.4|-4.4|
74032347|NCT00069576|147617756|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.33|TWO_SIDED|97.0|0.1|2.2|||Chi-squared|||Analysis for birth trauma||2.20|0.10|0.33
74032348|NCT00069576|147617757|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.68|1.28||||||||1.28|0.68|
74032349|NCT00069576|147617758|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|||<|0.001|TWO_SIDED|97.0|0.32|0.76|||Chi-squared|||||0.76|0.32|<0.001
74032350|NCT00069576|147617759|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||<|0.001|TWO_SIDED|97.0|0.26|0.66|||Chi-squared|||||0.66|0.26|<0.001
74032351|NCT00069576|147617760|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.27|TWO_SIDED|97.0|0.53|1.23|||Chi-squared|||||1.23|0.53|0.27
74032352|NCT00069576|147617761|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
74032353|NCT00069576|147617762|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.49|TWO_SIDED|97.0|0.7|1.99|||Chi-squared|||||1.99|0.70|0.49
74032354|NCT00069576|147617763|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74032355|NCT00069576|147617764|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.19|TWO_SIDED|97.0|0.51|1.18|||Chi-squared|||||1.18|0.51|0.19
74032356|NCT00069576|147617765|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.32|TWO_SIDED|97.0|0.44|1.36|||Chi-squared|||||1.36|0.44|0.32
74032357|NCT00069576|147617766|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.33|TWO_SIDED|97.0|0.26|1.67|||Chi-squared|||||1.67|0.26|0.33
74032358|NCT00069576|147617767|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.86|TWO_SIDED|97.0|0.81|1.29|||Chi-squared|||||1.29|0.81|0.86
74032359|NCT00069576|147617768|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.02|TWO_SIDED|97.0|0.64|0.99|||Chi-squared|||||0.99|0.64|0.02
74032360|NCT00069576|147617769|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.02|TWO_SIDED|97.0|0.14|0.97|||Chi-squared|||||0.97|0.14|0.02
74032361|NCT00069576|147617770|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46||||0.02|TWO_SIDED|97.0|0.22|0.97|||Chi-squared|||||0.97|0.22|0.02
74032362|NCT00069576|147617771|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.63||||0.01|TWO_SIDED|97.0|0.42|0.96|||Chi-squared|||||0.96|0.42|0.01
74032363|NCT00069576|147617772|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74032364|NCT00069576|147617773|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74032365|NCT00069576|147617774|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.71|1.1||||||||1.10|0.71|
74032366|NCT00069576|147617775|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.65|1.69||||||||1.69|0.65|
74032367|NCT00069576|147617776|SUPERIORITY||Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.74|2.05||||||||2.05|0.74|
74032368|NCT00069576|147617777|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.36|1.62||||||||1.62|0.36|
74032369|NCT00069576|147617778|SUPERIORITY_OR_OTHER|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
74032370|NCT00783705|147617946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.39|TWO_SIDED|95.0|0.7|3.0|||Generalized estimating equation model|||Generalized estimating equation model on lesions (progressive disease vs. complete response/stable disease) was used to account for intra-patient correlation in the lesion-specific analysis.||3.0|0.7|0.39
74032371|NCT00783705|147617950|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.||||0.10
74032372|NCT00783705|147617951|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.||||0.03
74032373|NCT00783705|147617952|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.||||0.58
74032374|NCT00783705|147617953|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.||||0.06
74032375|NCT00783705|147617954|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.||||0.63
74032376|NCT00783705|147617955|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.||||0.22
74032377|NCT00783705|147617956|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Total Glutathione level between arms.||||0.06
74032378|NCT00783705|147617957|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.||||0.35
74032379|NCT00783705|147617958|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CRP level between arms.||||0.80
74032380|NCT00783705|147617959|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.||||0.22
74032381|NCT00783705|147617960|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.||||0.74
74032382|NCT00783705|147617961|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.||||0.55
74032383|NCT00783705|147617962|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Nitrotyrosine level between arms.||||0.91
74032384|NCT00783705|147617963|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.||||0.46
74032385|NCT00783705|147617964|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.||||0.52
74032386|NCT04415489|147617974|SUPERIORITY|||||||0.57||||||The a priori threshold for statistical significance was p \< 0.05.|Fisher Exact|||||||0.57
74032387|NCT04415489|147617975|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance was p \< 0.05.|t-test, 2 sided|||||||<0.01
74032388|NCT04415489|147617976|SUPERIORITY|||||||0.11||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||0.11
74032389|NCT04415489|147617977|SUPERIORITY|||||||0.16||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.16
74032390|NCT04415489|147617978|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||< 0.01
74032391|NCT04415489|147617982|SUPERIORITY|||||||0.12||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||0.12
73977518|NCT02434328|147501054|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-5.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.1|-5.0|
73977519|NCT02434328|147501054|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-1.9|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.2|-1.9|
73977520|NCT02434328|147501054|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-0.4|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.8|-0.4|
73977521|NCT02434328|147501054|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-1.3|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Number of subjects with \>=5 letter loss from baseline in BCVA (letters read) at each post-baseline visit - Week 24||7.8|-1.3|
73977522|NCT02434328|147501054|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.7|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.3|-1.7|
73977523|NCT02434328|147501054|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.2|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.9|-3.2|
73977524|NCT02434328|147501054|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-0.7|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||8.3|-0.7|
73977525|NCT02434328|147501054|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-3.8|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-3.8|
73977526|NCT02434328|147501054|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-1.4|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.0|-1.4|
73977527|NCT02434328|147501054|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.1|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.7|-5.1|
74032392|NCT01617434|147617983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|||<|0.0001||95.0|-1.39|-0.99|||Mixed Models Analysis|||The null hypothesis of no difference between the two treatment arms with regard to changes from baseline in HbA1c (%) after 26 weeks of randomised treatment was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline HbA1c as a covariate, all nested within visit.||-0.99|-1.39|<0.0001
74032393|NCT01617434|147617984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.0001||95.0|-1.7|-0.86|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-0.86|-1.70|<0.0001
73977528|NCT02434328|147501054|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.5|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.7|-2.5|
73977529|NCT02434328|147501054|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.4|-2.8|
73977530|NCT02434328|147501054|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.6|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.8|-3.6|
73977531|NCT02434328|147501054|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.0|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-4.0|
74032394|NCT01617434|147617985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59|||<|0.0001||95.0|-2.01|-1.18|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-1.18|-2.01|<0.0001
74032395|NCT01617434|147617986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.11|||<|0.0001||95.0|-3.85|-2.37|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-2.37|-3.85|<0.0001
73977532|NCT02434328|147501054|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.4|-2.8|
74032396|NCT01617434|147617987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.91|||<|0.0001||95.0|5.45|14.59|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.||14.59|5.45|<0.0001
73948851|NCT01976364|147430820|OTHER||LS mean difference|0.66|||||TWO_SIDED|95.0|-4.03|5.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.35|-4.03|
73948852|NCT01976364|147430821|OTHER||LS mean difference|-0.1535|||||TWO_SIDED|95.0|-2.1444|1.8374||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.8374|-2.1444|
73948853|NCT01976364|147430821|OTHER||LS mean difference|-0.566|||||TWO_SIDED|95.0|-1.9054|0.7735||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7735|-1.9054|
73948854|NCT01976364|147430821|OTHER||LS mean difference|-0.7991|||||TWO_SIDED|95.0|-3.0053|1.4071||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.4071|-3.0053|
73948855|NCT01976364|147430821|OTHER||LS mean difference|0.0626|||||TWO_SIDED|95.0|-1.5767|1.7018||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.7018|-1.5767|
73948856|NCT01976364|147430821|OTHER||LS mean difference|0.3672|||||TWO_SIDED|95.0|-1.8107|2.545||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.5450|-1.8107|
73948857|NCT01976364|147430822|OTHER||LS mean difference|0.33|||||TWO_SIDED|95.0|-0.85|1.51||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.51|-0.85|
73948858|NCT01976364|147430822|OTHER||LS mean difference|0.33|||||TWO_SIDED|95.0|-1.04|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.69|-1.04|
73948859|NCT01976364|147430822|OTHER||LS mean difference|-0.77|||||TWO_SIDED|95.0|-2.09|0.55||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.55|-2.09|
73948860|NCT01976364|147430822|OTHER||LS mean difference|-0.77|||||TWO_SIDED|95.0|-2.44|0.91||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.91|-2.44|
73948861|NCT01976364|147430822|OTHER||LS mean difference|0.52|||||TWO_SIDED|95.0|-0.96|2.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.00|-0.96|
73948862|NCT01976364|147430823|OTHER||LS mean difference|-0.47|||||TWO_SIDED|95.0|-2.22|1.29||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.29|-2.22|
73948863|NCT01976364|147430823|OTHER||LS mean difference|-0.86|||||TWO_SIDED|95.0|-2.65|0.92||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.92|-2.65|
73948864|NCT01976364|147430823|OTHER||LS mean difference|-0.66|||||TWO_SIDED|95.0|-2.68|1.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.36|-2.68|
73948865|NCT01976364|147430823|OTHER||LS mean difference|0.76|||||TWO_SIDED|95.0|-1.31|2.83||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.83|-1.31|
73948866|NCT01976364|147430823|OTHER||LS mean difference|-0.09|||||TWO_SIDED|95.0|-2.01|1.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.84|-2.01|
74032397|NCT01617434|147617988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.12|||<|0.0001||95.0|9.92|40.84|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.||40.84|9.92|<0.0001
74032398|NCT03283163|147617992|OTHER|||||||0.04|||||||t-test, 2 sided|||paired samples t-test to compare PTSD severity from baseline to endpoint (week 13).||||.040
73948867|NCT01976364|147430824|OTHER||LS mean difference|0.22|||||TWO_SIDED|95.0|-1.09|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-1.09|
73948868|NCT01976364|147430824|OTHER||LS mean difference|0.17|||||TWO_SIDED|95.0|-1.39|1.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.73|-1.39|
73948869|NCT01976364|147430824|OTHER||LS mean difference|-0.53|||||TWO_SIDED|95.0|-2.15|1.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.08|-2.15|
73948870|NCT01976364|147430824|OTHER||LS mean difference|0.32|||||TWO_SIDED|95.0|-1.49|2.13||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.13|-1.49|
73948871|NCT01976364|147430824|OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-1.89|1.86||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.86|-1.89|
73948872|NCT01976364|147430825|OTHER||LS mean difference|0.48|||||TWO_SIDED|95.0|-1.08|2.05||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.05|-1.08|
73948873|NCT01976364|147430825|OTHER||LS mean difference|1.25|||||TWO_SIDED|95.0|-0.49|2.99||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.99|-0.49|
73977533|NCT02434328|147501054|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.3|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.7|-4.3|
73977534|NCT02434328|147501054|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.4|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.8|-4.4|
73948874|NCT01976364|147430825|OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.91|2.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.31|-0.91|
73977535|NCT02434328|147501054|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-6.0|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.6|-6.0|
73948875|NCT01976364|147430825|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-1.57|1.96||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.96|-1.57|
73948876|NCT01976364|147430825|OTHER||LS mean difference|1.73|||||TWO_SIDED|95.0|-0.06|3.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.52|-0.06|
73948877|NCT01976364|147430826|OTHER||LS mean difference|0.71|||||TWO_SIDED|95.0|-1.01|2.42||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.42|-1.01|
73948878|NCT01976364|147430826|OTHER||LS mean difference|0.34|||||TWO_SIDED|95.0|-1.49|2.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.18|-1.49|
73948879|NCT01976364|147430826|OTHER||LS mean difference|-1.81|||||TWO_SIDED|95.0|-3.7|0.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.09|-3.70|
73948880|NCT01976364|147430826|OTHER||LS mean difference|-1.76|||||TWO_SIDED|95.0|-3.99|0.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.48|-3.99|
73948881|NCT01976364|147430826|OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-2.3|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.69|-2.30|
73977536|NCT02434328|147501054|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-5.2|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.5|-5.2|
74032399|NCT03283163|147617993|OTHER|||||||0.69|||||||t-test, 2 sided|||paired samples t-test to compare degree of pain-related interference from baseline to endpoint (week 13).||||.69
73948882|NCT01976364|147430827|OTHER||LS mean difference|-0.68|||||TWO_SIDED|95.0|-2.05|0.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.69|-2.05|
74032400|NCT03283163|147617994|OTHER|||||||0.098|||||||t-test, 2 sided|||paired samples t-test to compare severity of pain catastrophizing from baseline to endpoint (week 13).||||.098
73948883|NCT01976364|147430827|OTHER||LS mean difference|-1.13|||||TWO_SIDED|95.0|-2.57|0.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.31|-2.57|
73948884|NCT01976364|147430827|OTHER||LS mean difference|-0.81|||||TWO_SIDED|95.0|-2.17|0.56||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.56|-2.17|
73948885|NCT01976364|147430827|OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-1.54|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.57|-1.54|
73948886|NCT01976364|147430827|OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-1.46|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-1.46|
73948887|NCT01976364|147430828|OTHER||LS mean difference|-0.36|||||TWO_SIDED|95.0|-2.06|1.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.35|-2.06|
73977537|NCT02434328|147501054|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-5.7|
73977538|NCT02434328|147501054|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-6.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.4|-6.5|
73977539|NCT02434328|147501054|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-5.1|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.8|-5.1|
73977540|NCT02434328|147501055|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.2|1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.6|-9.2|
74032401|NCT03283163|147617995|OTHER|||||||0.194|||||||t-test, 2 sided|||paired samples t-tests were conducted for comparison of resting ALLO+PA levels from baseline to endpoint (week 13).||||.194
73948888|NCT01976364|147430828|OTHER||LS mean difference|-0.86|||||TWO_SIDED|95.0|-2.51|0.79||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.79|-2.51|
73948889|NCT01976364|147430828|OTHER||LS mean difference|-1.71|||||TWO_SIDED|95.0|-3.66|0.23||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.23|-3.66|
73948890|NCT01976364|147430828|OTHER||LS mean difference|-0.47|||||TWO_SIDED|95.0|-2.25|1.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.32|-2.25|
73948891|NCT01976364|147430828|OTHER||LS mean difference|0.95|||||TWO_SIDED|95.0|-0.82|2.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.73|-0.82|
73948892|NCT01976364|147430829|OTHER||LS mean difference|0.78|||||TWO_SIDED|95.0|-1.27|2.82||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.82|-1.27|
74032402|NCT03283163|147617996|OTHER|paired samples t-test||||||0.343|||||||t-test, 2 sided|||paired samples t-tests were conducted for comparison of peak ALLO+PA levels (30 minutes post MAXEX) from baseline to endpoint (week 13).||||.343
74039479|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.34|-0.97|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.97|-2.34|<.0001
73948893|NCT01976364|147430829|OTHER||LS mean difference|-0.38|||||TWO_SIDED|95.0|-2.46|1.71||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.71|-2.46|
73948894|NCT01976364|147430829|OTHER||LS mean difference|-0.57|||||TWO_SIDED|95.0|-2.72|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.57|-2.72|
73948895|NCT01976364|147430829|OTHER||LS mean difference|0.28|||||TWO_SIDED|95.0|-1.81|2.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.36|-1.81|
73948896|NCT01976364|147430829|OTHER||LS mean difference|0.53|||||TWO_SIDED|95.0|-1.58|2.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.63|-1.58|
73977541|NCT02434328|147501055|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.1|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.7|-8.1|
73977542|NCT02434328|147501055|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.5|-8.4|
73977543|NCT02434328|147501055|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.4|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.7|-5.4|
73977544|NCT02434328|147501055|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.2|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.0|-8.2|
73977545|NCT02434328|147501055|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.3|-9.0|
73977546|NCT02434328|147501055|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-9.3|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.5|-9.3|
73977547|NCT02434328|147501055|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.6|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.8|-9.6|
73977548|NCT02434328|147501055|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-9.6|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||2.2|-9.6|
73977549|NCT02434328|147501055|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-7.6|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.2|-7.6|
73977550|NCT02434328|147501055|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.5|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.0|-7.5|
73977551|NCT02434328|147501055|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-5.4|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-5.4|
73948897|NCT01976364|147430830|OTHER||LS mean difference|-1.67|||||TWO_SIDED|95.0|-3.67|0.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.32|-3.67|
73948898|NCT01976364|147430830|OTHER||LS mean difference|-0.61|||||TWO_SIDED|95.0|-2.86|1.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.63|-2.86|
73948899|NCT01976364|147430830|OTHER||LS mean difference|-0.09|||||TWO_SIDED|95.0|-2.27|2.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.09|-2.27|
74032403|NCT04238663|147618004|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|1.06|||||TWO_SIDED|90.0|0.976|1.16|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator.|||1.16|0.976|
73948900|NCT01976364|147430830|OTHER||LS mean difference|0.73|||||TWO_SIDED|95.0|-1.49|2.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.95|-1.49|
74032404|NCT04238663|147618004|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|0.983|||||TWO_SIDED|90.0|0.897|1.08||||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.||1.08|0.897|
73948901|NCT01976364|147430830|OTHER||LS mean difference|-0.79|||||TWO_SIDED|95.0|-3.1|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-3.10|
73948902|NCT01976364|147430831|OTHER||LS mean difference|0.93|||||TWO_SIDED|95.0|-0.95|2.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.81|-0.95|
73948903|NCT01976364|147430831|OTHER||LS mean difference|0.11|||||TWO_SIDED|95.0|-1.72|1.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.95|-1.72|
73948904|NCT01976364|147430831|OTHER||LS mean difference|-0.25|||||TWO_SIDED|95.0|-2.4|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.90|-2.40|
73948905|NCT01976364|147430831|OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-0.93|3.07||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.07|-0.93|
73948906|NCT01976364|147430831|OTHER||LS mean difference|0.38|||||TWO_SIDED|95.0|-1.62|2.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.38|-1.62|
73948907|NCT01976364|147430832|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.9|2.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.5|-0.9|
73948908|NCT01976364|147430832|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-1.1|2.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.2|-1.1|
73948909|NCT01976364|147430832|OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-2.4|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-2.4|
73948910|NCT01976364|147430832|OTHER||LS mean difference|1.1|||||TWO_SIDED|95.0|-0.8|2.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.9|-0.8|
73948911|NCT01976364|147430832|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-1.1|2.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.6|-1.1|
73948912|NCT01976364|147430833|OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.4|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.2|-0.4|
73948913|NCT01976364|147430833|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-1.0|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-1.0|
73948914|NCT01976364|147430833|OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-1.6|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-1.6|
73948915|NCT01976364|147430833|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-0.9|
73948916|NCT01976364|147430833|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-0.9|
73977552|NCT02434328|147501055|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-7.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.5|-7.7|
73948917|NCT01976364|147430834|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-0.6|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.6|-0.6|
73948918|NCT01976364|147430834|OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.3|1.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.7|-0.3|
73948919|NCT01976364|147430834|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-1.0|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.2|-1.0|
73948920|NCT01976364|147430834|OTHER||LS mean difference|1.2|||||TWO_SIDED|95.0|0.0|2.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.3|0.0|
73948921|NCT01976364|147430834|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.3|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.9|-0.3|
73948922|NCT01976364|147430835|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
73948923|NCT01976364|147430835|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
73977553|NCT02434328|147501055|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-7.7|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.0|-7.7|
73977554|NCT02434328|147501055|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-10.8|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||1.4|-10.8|
73977555|NCT02434328|147501055|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-8.9|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||3.2|-8.9|
73948924|NCT01976364|147430835|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
73948925|NCT01976364|147430835|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
73948926|NCT01976364|147430835|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
73948927|NCT01976364|147430836|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|0.0|
73948928|NCT01976364|147430836|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
73948929|NCT01976364|147430836|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
73977556|NCT02434328|147501055|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.5|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||2.9|-9.5|
73977557|NCT02434328|147501055|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-7.9|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.5|-7.9|
73977558|NCT02434328|147501055|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-8.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.1|-8.1|
73977559|NCT02434328|147501055|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.6|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.6|-5.6|
73977560|NCT02434328|147501055|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.3|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||3.8|-8.3|
73977561|NCT02434328|147501055|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-7.4|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.5|-7.4|
73977562|NCT02434328|147501055|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.5|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.8|-6.5|
73977563|NCT02434328|147501055|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-8.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.1|-8.1|
73977564|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-17.7|STANDARD_ERROR_OF_MEAN|7.57|||TWO_SIDED|95.0|-32.6|-2.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||-2.9|-32.6|
74032405|NCT04238663|147618004|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|0.926|||||TWO_SIDED|90.0|0.851|1.01|||||For Ratio of geometric least square mean (GLSM): EU is the numerator and US Avastin acts as the denominator|||1.01|0.851|
74032406|NCT04238663|147618005|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.07|||||TWO_SIDED|90.0|1.0|1.14|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator|||1.14|1.00|
74032407|NCT04238663|147618005|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.998|||||TWO_SIDED|90.0|0.944|1.05|||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.|||1.05|0.944|
74032408|NCT04238663|147618005|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.934|||||TWO_SIDED|90.0|0.884|0.988|||||EU Avastin corresponds to the numerator and US Avastin corresponds to the denominator|||0.988|0.884|
73977565|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-29.5|STANDARD_ERROR_OF_MEAN|8.18|||TWO_SIDED|95.0|-45.6|-13.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||-13.4|-45.6|
73977566|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-30.3|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-46.9|-13.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-13.7|-46.9|
73977567|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|9.51|||TWO_SIDED|95.0|-58.9|-21.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||-21.6|-58.9|
73977568|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|9.12|||TWO_SIDED|95.0|-20.9|15.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||15.0|-20.9|
74032409|NCT01193348|147618012|SUPERIORITY_OR_OTHER||Percent of Complete TMA Response|63.6|||||TWO_SIDED|95.0|40.7|82.8||||||||82.8|40.7|
74032410|NCT01193348|147618013|SUPERIORITY_OR_OTHER||Percent of Complete Hematologic Response|81.8|||||TWO_SIDED|95.0|59.7|94.8||||||||94.8|59.7|
74032411|NCT01193348|147618014|SUPERIORITY_OR_OTHER||Percent of Platelet Count Normalization|95.0|||||TWO_SIDED|95.0|77.2|99.9||||||||99.9|77.2|
74032412|NCT01193348|147618015|SUPERIORITY_OR_OTHER||Percent of eGFR Improvement|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
74032413|NCT01193348|147618016|SUPERIORITY_OR_OTHER||LS mean change from baseline|204.96|||<|0.0001|TWO_SIDED|95.0|164.44|245.49|||ANOVA|||||245.49|164.44|<0.0001
73948930|NCT01976364|147430836|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
73948931|NCT01976364|147430836|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
73948932|NCT01976364|147430837|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
73948933|NCT01976364|147430837|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
73948934|NCT01976364|147430837|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
73948935|NCT01976364|147430837|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
73948936|NCT01976364|147430837|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
73948937|NCT01976364|147430838|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
73977569|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-47.8|STANDARD_ERROR_OF_MEAN|9.42|||TWO_SIDED|95.0|-66.3|-29.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||-29.3|-66.3|
73977570|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|9.34|||TWO_SIDED|95.0|-42.0|-5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||-5.4|-42.0|
73977571|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-33.7|STANDARD_ERROR_OF_MEAN|9.54|||TWO_SIDED|95.0|-52.4|-15.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||-15.0|-52.4|
73977572|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-30.4|STANDARD_ERROR_OF_MEAN|8.94|||TWO_SIDED|95.0|-48.0|-12.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||-12.9|-48.0|
73977573|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-44.7|STANDARD_ERROR_OF_MEAN|9.57|||TWO_SIDED|95.0|-63.5|-25.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||-25.9|-63.5|
73948938|NCT01976364|147430838|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
73948939|NCT01976364|147430838|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
73948940|NCT01976364|147430838|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
73948941|NCT01976364|147430838|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
73948942|NCT01976364|147430839|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
73948943|NCT01976364|147430839|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
74032414|NCT01193348|147618017|SUPERIORITY_OR_OTHER||Percent of Complete TMA Response|68.2|||||TWO_SIDED|95.0|45.1|86.1||||||||86.1|45.1|
73948944|NCT01976364|147430839|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
73948945|NCT01976364|147430839|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0|-0.3|
73948946|NCT01976364|147430839|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.2|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0|-0.2|
73948947|NCT01976364|147430840|OTHER||LS mean difference|-2.9|||||TWO_SIDED|95.0|-6.2|0.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.4|-6.2|
73948948|NCT01976364|147430840|OTHER||LS mean difference|-1.5|||||TWO_SIDED|95.0|-5.8|2.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.7|-5.8|
73948949|NCT01976364|147430840|OTHER||LS mean difference|-6.3|||||TWO_SIDED|95.0|-10.2|-2.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||-2.4|-10.2|
73948950|NCT01976364|147430840|OTHER||LS mean difference|-2.8|||||TWO_SIDED|95.0|-7.3|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.6|-7.3|
73948951|NCT01976364|147430840|OTHER||LS mean difference|-4.9|||||TWO_SIDED|95.0|-9.9|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-9.9|
73948952|NCT02318719|147430852|SUPERIORITY||Difference of least square mean|-0.41||||0.017|TWO_SIDED|95.0|-0.74|-0.07||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 15 mg/day at Week 14||-0.07|-0.74|0.0170
73948953|NCT02318719|147430852|SUPERIORITY||Difference of least square means|-0.47||||0.0058|TWO_SIDED|95.0|-0.81|-0.14||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 20 mg/day at Week 14||-0.14|-0.81|0.0058
73948954|NCT02318719|147430852|SUPERIORITY||Difference of least square means|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.44||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 30 mg/day at Week 14||-0.44|-1.10|<0.0001
73948955|NCT00423293|147430870|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|95.0||||One-sided p-value comparing to a rate of 78% (the historical rate was updated after the study design).|Chi-squared|||The RT+ 5-FU + Mitomycin-C arm on previous Radiation Therapy Oncology Group (RTOG) study 9811 \[NCT00003596\] had a 77% rate of \>= grade 2 GI and GU adverse events. The null hypothesis for this study design was a 15% reduction for that rate. Fifty-four evaluable patients provides 80% power to detect a 15% reduction, using a one-sided chi-squared test with a type I error rate of 0.05. (With 52 patients, the power is reduced to 78%.)||||0.50
73948956|NCT00423293|147430872|SUPERIORITY|||||||0.5|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GI grade 2+ adverse events were compared to the historical rate of 73%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.5
73948957|NCT00423293|147430872|SUPERIORITY|||||||0.18|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GU grade 2+ adverse events were compared to the historical rate of 20%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.18
73948958|NCT00423293|147430872|SUPERIORITY|||||||0.032|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with hematologic grade 2+ adverse events were compared to the historical rate of 85%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.032
73948959|NCT00423293|147430872|SUPERIORITY|||||||0.1|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with skin grade 2+ adverse events were compared to the historical rate of 83%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.10
73948960|NCT00423293|147430872|SUPERIORITY|||||||0.12|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 2+ adverse events were compared to the historical rate of 98%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.12
73948961|NCT00423293|147430872|SUPERIORITY|||||||0.23|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 3+ adverse events were compared to the historical rate of 87%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.23
74032415|NCT01193348|147618018|SUPERIORITY_OR_OTHER||Percent of Complete Hematologic Response|90.9|||||TWO_SIDED|95.0|70.8|98.9||||||||98.9|70.8|
74032416|NCT01193348|147618019|SUPERIORITY_OR_OTHER||Percent of Platelet Count Normalization|95.5|||||TWO_SIDED|95.0|77.2|99.9||||||||99.9|77.2|
73948962|NCT03154359|147430890|OTHER|||||||0.197|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.197
73948963|NCT03154359|147430890|OTHER|||||||0.562|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.562
73948964|NCT03154359|147430891|OTHER|||||||0.558|||||||t-test, 2 sided|||||||0.558
73948965|NCT03154359|147430892|OTHER|||||||0.147|||||||t-test, 2 sided|||||||0.147
73977574|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-19.2|STANDARD_ERROR_OF_MEAN|9.24|||TWO_SIDED|95.0|-37.3|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||-1.1|-37.3|
73977575|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-49.9|STANDARD_ERROR_OF_MEAN|9.68|||TWO_SIDED|95.0|-68.9|-30.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||-30.9|-68.9|
73977576|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-28.1|STANDARD_ERROR_OF_MEAN|9.01|||TWO_SIDED|95.0|-45.8|-10.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||-10.4|-45.8|
73977577|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-43.1|STANDARD_ERROR_OF_MEAN|9.86|||TWO_SIDED|95.0|-62.4|-23.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||-23.7|-62.4|
73977578|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|9.34|||TWO_SIDED|95.0|-49.5|-12.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||-12.8|-49.5|
73977579|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-45.8|STANDARD_ERROR_OF_MEAN|9.7|||TWO_SIDED|95.0|-64.9|-26.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||-26.8|-64.9|
73977580|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|9.31|||TWO_SIDED|95.0|-42.0|-5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||-5.4|-42.0|
73977581|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|9.69|||TWO_SIDED|95.0|-66.4|-28.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||-28.3|-66.4|
73977582|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-28.0|STANDARD_ERROR_OF_MEAN|9.43|||TWO_SIDED|95.0|-46.5|-9.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||-9.5|-46.5|
73977583|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-40.9|STANDARD_ERROR_OF_MEAN|9.94|||TWO_SIDED|95.0|-60.4|-21.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||-21.4|-60.4|
73977584|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|9.48|||TWO_SIDED|95.0|-49.6|-12.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||-12.4|-49.6|
74032417|NCT01193348|147618020|SUPERIORITY_OR_OTHER||Percent of eGFR Improvement|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
74032418|NCT01193348|147618021|SUPERIORITY_OR_OTHER||LS mean change from baseline|165.43|||<|0.0001|TWO_SIDED|95.0|98.43|232.43|||ANOVA|||||232.43|98.43|<0.0001
73948966|NCT03154359|147430893|OTHER|||||||0.495|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.495
73948967|NCT03154359|147430893|OTHER|||||||0.955|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.955
73948968|NCT03154359|147430894|OTHER|||||||0.991|||||||t-test, 2 sided|||||||0.991
73948969|NCT03154359|147430895|OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
73948970|NCT03154359|147430896|OTHER|||||||0.456|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.456
73948971|NCT03154359|147430896|OTHER|||||||0.822|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.822
73948972|NCT03154359|147430897|OTHER|||||||0.343|||||||t-test, 2 sided|||||||0.343
73948973|NCT03154359|147430898|OTHER|||||||0.539|||||||t-test, 2 sided|||||||0.539
73948974|NCT03154359|147430899|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.130
73948975|NCT03154359|147430900|OTHER|||||||0.652|||||||t-test, 2 sided|||||||0.652
73948976|NCT00365378|147430904|SUPERIORITY_OR_OTHER||Vaccine Efficacy|94.3||||||95.0|87.8|97.7|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||97.7|87.8|
73948977|NCT00365378|147430905|SUPERIORITY_OR_OTHER||Vaccine Efficacy|100.0||||||95.0|84.0|100.0|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||100.0|84.0|
73948978|NCT00058019|147430984|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||||||0.022
73948979|NCT00058019|147430985|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
73948980|NCT00058019|147430987|SUPERIORITY_OR_OTHER|||||||0.695|TWO_SIDED|95.0|||||Log Rank|||||||0.695
73948981|NCT00058019|147430988|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED|95.0|||||Log Rank|||||||0.55
73977585|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-61.9|-23.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||-23.3|-61.9|
73977586|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-29.1|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-47.9|-10.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||-10.3|-47.9|
73977587|NCT02434328|147501056|OTHER|Treatment difference|Least Squares Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|9.87|||TWO_SIDED|95.0|-62.0|-23.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-23.3|-62.0|
73977588|NCT02434328|147501057|OTHER|Treatment difference|Least Squares Mean Difference|-36.1|STANDARD_ERROR_OF_MEAN|9.13|||TWO_SIDED|95.0|-54.0|-18.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-18.1|-54.0|
73977589|NCT02434328|147501058|OTHER|Treatment difference|Least Squares Mean Difference|-36.3|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-55.1|-17.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-17.6|-55.1|
73977590|NCT02434328|147501059|OTHER|Treatment difference|Least Squares Mean Difference|-30.8|STANDARD_ERROR_OF_MEAN|8.53|||TWO_SIDED|95.0|-47.6|-14.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||-14.1|-47.6|
73977591|NCT02434328|147501059|OTHER|Treatment difference|Least Squares Mean Difference|-33.5|STANDARD_ERROR_OF_MEAN|8.84|||TWO_SIDED|95.0|-50.8|-16.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||-16.1|-50.8|
73977592|NCT02434328|147501060|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.0|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||0.7|0.0|
73977593|NCT02434328|147501060|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.1|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||0.6|-0.1|
73977594|NCT02434328|147501060|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.0|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||0.6|0.0|
74032419|NCT03259334|147618034|SUPERIORITY|||||||0.617|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.617
74032420|NCT03259334|147618034|SUPERIORITY|||||||0.018|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.018
74032421|NCT03259334|147618035|SUPERIORITY|||||||0.253|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.253
74032422|NCT03259334|147618035|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.002
74032423|NCT03259334|147618036|SUPERIORITY|||||||0.764|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.764
74032424|NCT03259334|147618036|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.080
74032425|NCT03259334|147618037|SUPERIORITY|||||||0.44|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.440
74032426|NCT03259334|147618037|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.002
74032427|NCT03259334|147618038|SUPERIORITY|||||||0.286|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.286
74032428|NCT03259334|147618038|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.005
74032429|NCT01678807|147618058|SUPERIORITY_OR_OTHER||Percent Difference|13.8|||||TWO_SIDED|95.0|-3.4|30.3|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||30.3|-3.4|
74032430|NCT01678807|147618058|SUPERIORITY_OR_OTHER||Percent Difference|10.8|||||TWO_SIDED|95.0|-6.4|27.4|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||27.4|-6.4|
74032431|NCT01678807|147618059|SUPERIORITY_OR_OTHER||Percent Difference|6.2|||||TWO_SIDED|95.0|0.4|14.8|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||14.8|0.4|
74032432|NCT01678807|147618059|SUPERIORITY_OR_OTHER||Percent Difference|6.2|||||TWO_SIDED|95.0|0.4|14.8|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||14.8|0.4|
74032433|NCT00701727|147618063|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||||||0.019
74032434|NCT00701727|147618064|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73948982|NCT00152971|147431006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|5.8||||0.0234||95.0|0.8|10.8||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||10.8|0.8|0.0234
73977595|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.8|||TWO_SIDED|95.0|-11.6|7.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||7.3|-11.6|
73977596|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|95.0|-13.6|6.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||6.0|-13.6|
74032435|NCT00701727|147618065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74032436|NCT00701727|147618066|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
74032437|NCT00701727|147618067|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73948983|NCT00152971|147431006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|8.4||||0.0009||95.0|3.4|13.3||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||13.3|3.4|0.0009
73948984|NCT00152971|147431007|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.2||||0.2139||95.0|-0.7|3.0|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||3.0|-0.7|0.2139
73948985|NCT00152971|147431007|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.8||||0.3628||95.0|-0.9|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.5|-0.9|0.3628
73948986|NCT00152971|147431008|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.9||||0.2309||95.0|-0.6|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.5|-0.6|0.2309
73948987|NCT00152971|147431008|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.5||||0.0602||95.0|-0.1|3.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||3.2|-0.1|0.0602
73948988|NCT00152971|147431009|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|5.9||||0.0194||95.0|1.0|10.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||10.9|1.0|0.0194
73948989|NCT00152971|147431009|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|8.9||||0.0004||95.0|4.0|13.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||13.9|4.0|0.0004
73948990|NCT00152971|147431010|SUPERIORITY_OR_OTHER|||||||0.5774||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.5774
73948991|NCT00152971|147431010|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
73948992|NCT00152971|147431011|SUPERIORITY_OR_OTHER|||||||0.7724||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.7724
73948993|NCT00152971|147431011|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0308
73948994|NCT00152971|147431012|SUPERIORITY_OR_OTHER|||||||0.4968||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4968
73977597|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|95.0|-14.3|5.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||5.3|-14.3|
73977598|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-13.7|6.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||6.4|-13.7|
73948995|NCT00152971|147431012|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
73948996|NCT00152971|147431014|SUPERIORITY_OR_OTHER|||||||0.1416||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1416
73948997|NCT00152971|147431014|SUPERIORITY_OR_OTHER|||||||0.0942||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0942
73948998|NCT03125941|147431028|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.49|2.05|||Chi-squared|||||2.05|0.49|1
73948999|NCT03125941|147431029|SUPERIORITY|||||||0.114|||||||Wilcoxon (Mann-Whitney)|||||||0.114
73949000|NCT03125941|147431030|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||||||0.294
73949001|NCT03125941|147431033|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.350
73949002|NCT03125941|147431034|SUPERIORITY|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
73949003|NCT03125941|147431036|SUPERIORITY||||||>|0.193||||||a priori threshold, bonferroni corrected 0.0125|Wilcoxon (Mann-Whitney)|||||||>0.193
73949004|NCT03125941|147431037|SUPERIORITY||||||>|0.2|||||||Wilcoxon (Mann-Whitney)|||||||>0.2
73949005|NCT03125941|147431038|SUPERIORITY||||||>|0.136|||||||Chi-squared|||||||>0.136
73949006|NCT03125941|147431039|SUPERIORITY||||||>|0.003||||||A priori threshold for statistical significans was 0.00125 due to multiple comparisons|Chi-squared|||||||>0.003
73949007|NCT03125941|147431040|SUPERIORITY||Odds Ratio (OR)|3.53||||0.03|TWO_SIDED|95.0|1.07|11.6|||Chi-squared|||||11.6|1.07|0.030
73949008|NCT00406419|147431068|SUPERIORITY||Weighted difference|18.5|||<|0.0001|TWO_SIDED|95.0|11.0|25.9|||Cochran-Mantel-Haenszel|||||25.9|11|< 0.0001
73949009|NCT00406419|147431068|SUPERIORITY||Weighted difference|21.4|||<|0.0001|TWO_SIDED|95.0|14.1|28.8|||Cochran-Mantel-Haenszel|||||28.8|14.1|< 0.0001
73949010|NCT00406419|147431069|SUPERIORITY||Weighted difference|30.8|||<|0.0001|TWO_SIDED|95.0|23.7|37.9|||Cochran-Mantel-Haenszel|||||37.9|23.7|< 0.0001
73949011|NCT00406419|147431069|SUPERIORITY||Weighted difference|34.5|||<|0.0001|TWO_SIDED|95.0|27.4|41.5|||Cochran-Mantel-Haenszel|||||41.5|27.4|< 0.0001
73949012|NCT02875834|147431109|OTHER||Mean Difference (Final Values)|0.904|||<|0.001|TWO_SIDED|95.0|0.876|0.933|||Mixed Models Analysis|||Results derived from a mixed effects model of log-transformed S-K levels. Fixed effects are: treatment group; visit; treatment-by-visit interaction; baseline S-K values (OLP and RTP); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses. Patient is a random effect. p-values given are for differences of LSMEANS. The back-transformation is to the original scale of the S-K measurement.||0.933|0.876|<0.001
73949013|NCT02875834|147431109|OTHER||Mean Difference (Final Values)|0.823|||<|0.001|TWO_SIDED|95.0|0.797|0.85|||Mixed Models Analysis|||||0.850|0.797|<0.001
73949014|NCT02875834|147431114|OTHER||Odds Ratio (OR)|6.3436|||<|0.001|TWO_SIDED|95.0|2.6866|14.9782|||Regression, Logistic|||Treatment group comparisons were made using a logistic regression model containing the following covariates: treatment group; both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase); baseline eGFR (during 48-hour open-label initial phase); age category (\<55, 55-64, \>=65 years); country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||14.9782|2.6866|<0.001
73949015|NCT02875834|147431114|OTHER||Odds Ratio (OR)|18.1876|||<|0.001|TWO_SIDED|95.0|7.1591|46.2054|||Regression, Logistic|||||46.2054|7.1591|<0.001
73949016|NCT02875834|147431116|OTHER||Mean Difference (Final Values)|7.266|||<|0.001|TWO_SIDED|95.0|4.318|10.214|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||10.214|4.318|<0.001
73949017|NCT02875834|147431116|OTHER||Mean Difference (Final Values)|12.079|||<|0.001|TWO_SIDED|95.0|9.118|15.04|||Regression, Linear|||||15.040|9.118|<0.001
73949018|NCT02875834|147431119|OTHER||Hazard Ratio (HR)|0.443|||<|0.001|TWO_SIDED|95.0|0.2954|0.6631|||Regression, Cox|||Results derived from a Cox Proportional Hazards model with the following covariates: treatment group, both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase), baseline eGFR, age category (\<55, 55-64, \>=65 years), country, baseline RAAS inhibitor, chronic kidney, disease heart failure, and diabetes mellitus statuses.||0.6631|0.2954|<0.001
73949019|NCT02875834|147431119|OTHER||Hazard Ratio (HR)|0.158|||<|0.001|TWO_SIDED|95.0|0.0992|0.2508|||Regression, Cox|||||0.2508|0.0992|<0.001
73949020|NCT01302938|147431135|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-3.9|0.6||||||Change at Week 12: Analysis was performed using an analysis of covariance (ANCOVA) with term for treatment with baseline value as a covariate.||0.6|-3.9|
73949021|NCT01302938|147431136|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|29.4|STANDARD_ERROR_OF_MEAN|35.4|||TWO_SIDED|95.0|-47.8|106.6||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||106.6|-47.8|
73949022|NCT01302938|147431136|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|28.0|STANDARD_ERROR_OF_MEAN|38.9|||TWO_SIDED|95.0|-55.4|111.4||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||111.4|-55.4|
73949023|NCT01302938|147431136|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|43.0|STANDARD_ERROR_OF_MEAN|31.4|||TWO_SIDED|95.0|-24.2|110.3||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||110.3|-24.2|
73949024|NCT01302938|147431137|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.67|1.67||||||Change at Week 1: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95 percent (%) confidence intervals (CI).||1.67|-0.67|
73949025|NCT01302938|147431137|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-1.0|1.83||||||Change at Week 4: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||1.83|-1.00|
73977599|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|5.11|||TWO_SIDED|95.0|-5.5|14.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||14.6|-5.5|
73977600|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|5.35|||TWO_SIDED|95.0|-16.3|4.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||4.7|-16.3|
73977601|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.13|||TWO_SIDED|95.0|-13.1|7.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||7.0|-13.1|
73977602|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|5.37|||TWO_SIDED|95.0|-12.6|8.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||8.5|-12.6|
73949026|NCT01302938|147431137|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-3.0|1.0||||||Change at Week 12: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||1.00|-3.00|
73949027|NCT01302938|147431138|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.3|1.8||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||1.8|-1.3|
73949028|NCT01302938|147431138|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.2|0.9||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.9|-2.2|
73949029|NCT01302938|147431141|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-0.8|1.9||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||1.9|-0.8|
73949030|NCT01302938|147431141|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-3.7|0.8||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.8|-3.7|
73949031|NCT01302938|147431141|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-6.3|0.4||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.4|-6.3|
73949032|NCT01302938|147431144|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.0|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|95.0|-33.2|13.2||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||13.2|-33.2|
73949033|NCT01302938|147431145|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.7|STANDARD_ERROR_OF_MEAN|8.6|||TWO_SIDED|95.0|-6.9|30.3||||||Change at Week 12; Coping Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||30.3|-6.9|
73977603|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|5.15|||TWO_SIDED|95.0|-15.2|5.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||5.1|-15.2|
74032438|NCT00701727|147618068|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74032439|NCT00701727|147618069|SUPERIORITY_OR_OTHER|||||||0.95|||||||t-test, 2 sided|||||||0.95
73870586|NCT01153724|147285101|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|108.78|STANDARD_DEVIATION|15.5||0.0009|TWO_SIDED|90.0|101.59|116.487||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol||116.487|101.590|0.0009
73870587|NCT01153724|147285101|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean|85.98|STANDARD_DEVIATION|19.4||0.0711|TWO_SIDED|90.0|79.277|93.253||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide||93.253|79.277|0.0711
73870588|NCT01153724|147285104|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|114.83|STANDARD_DEVIATION|33.5||0.1539|TWO_SIDED|90.0|99.94|131.932||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol||131.932|99.940|0.1539
73870589|NCT01153724|147285104|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|74.48|STANDARD_DEVIATION|1.068||0.8574|TWO_SIDED|90.0|66.619|83.266||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide||83.266|66.619|0.8574
73870590|NCT01153724|147285105|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|74.08|STANDARD_DEVIATION|14.6||0.9646|TWO_SIDED|90.0|69.105|79.418||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol||79.418|69.105|0.9646
73870591|NCT03334812|147285108|SUPERIORITY||Mean Difference (Net)|0.18||||0.1219|TWO_SIDED|95.0|-0.15|0.51|||Mixed Effect Model Repeat Measurement|||SCD/HNWB||0.51|-0.15|0.1219
73949034|NCT01302938|147431145|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.0|STANDARD_ERROR_OF_MEAN|11.4|||TWO_SIDED|95.0|-16.7|32.7||||||Change at Week 12; Concern Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||32.7|-16.7|
73949035|NCT01302938|147431145|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|10.3|STANDARD_ERROR_OF_MEAN|10.9|||TWO_SIDED|95.0|-13.3|33.8||||||Change at Week 12; Sleep Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||33.8|-13.3|
74032440|NCT05113953|147618070|SUPERIORITY||Treatment Difference|-0.42||||0.1893|TWO_SIDED|95.0|-1.06|0.21||P-value was analysed by MMRM method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, interaction term of treatment by visit week.|MMRM|||||0.21|-1.06|0.1893
73870592|NCT03334812|147285108|SUPERIORITY||Mean Difference (Net)|-0.01||||0.5438|TWO_SIDED|95.0|-0.28|0.25|||Mixed Effect Model Repeat Measurement|||DTBT/HWB||0.25|-0.28|0.5438
73870593|NCT03334812|147285109|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.3067|TWO_SIDED|95.0|-0.19|0.31|||Mixed Effect Model Repeat Measurement|||||0.31|-0.19|0.3067
73870594|NCT03334812|147285111|SUPERIORITY||Mean Difference (Net)|26.23||||0.0404|TWO_SIDED|95.0|-3.86|56.32|||Mixed Effect Model Repeat Measurement|||Week 4||56.32|-3.86|0.0404
73870595|NCT03334812|147285111|SUPERIORITY||Mean Difference (Net)|27.82||||0.1381|TWO_SIDED|95.0|-26.5|82.1|||Mixed Effect Model Repeat Measurement|||Week 12||82.10|-26.5|0.1381
73870596|NCT03334812|147285111|SUPERIORITY||Mean Difference (Net)|23.8||||0.1168|TWO_SIDED|96.0|-19.3|66.89|||Mixed Models Analysis|||Week 28 (EOS)||66.89|-19.3|0.1168
73870597|NCT03334812|147285112|SUPERIORITY||Mean Difference (Net)|-0.01||||0.5175|TWO_SIDED|95.0|-0.26|0.25|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 12||0.25|-0.26|0.5175
73870598|NCT03334812|147285112|SUPERIORITY||Mean Difference (Net)|0.19||||0.1476|TWO_SIDED|95.0|-0.22|0.6|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 28||0.60|-0.22|0.1476
73870599|NCT00524472|147285167|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.0043|TWO_SIDED|95.0|0.39|0.97||"P-values for combined sites: significant if P \< 0.0085 for efficacy. Adjusted for interim analysis.~Confidence intervals adjusted for interim analysis."|Cochran-Mantel-Haenszel||Hyperinsulinemic-normoglycemic clamp|||0.97|0.39|0.0043
73870600|NCT00524472|147285168|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.29|TWO_SIDED|95.0|0.75|1.13|||Cochran-Mantel-Haenszel||HN vs. standard|||1.13|0.75|0.29
73870601|NCT00524472|147285169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.99|TWO_SIDED|95.0|0.91|1.21|||Regression, Cox|||||1.21|0.91|0.99
73870602|NCT00524472|147285170|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.025|TWO_SIDED|95.0|0.98|1.31|||Regression, Cox||HN vs. Standard|||1.31|0.98|0.025
73870603|NCT00524472|147285171|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.52||||0.12|TWO_SIDED|95.0|0.74|3.11|||Cochran-Mantel-Haenszel||HN vs. standard|||3.11|0.74|0.12
73870604|NCT00524472|147285172|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.085|TWO_SIDED|95.0|0.72|1.07|||Cochran-Mantel-Haenszel||HN vs. Standard|||1.07|0.72|0.085
73870605|NCT02508428|147285173|EQUIVALENCE|Differences in survivorship among the Marathon and Enduron liners were evaluated with a Log Rank test.|||||<|0.001||||||A p-value of 0.05 was used as the threshold for statistical significance.|Log Rank|||Survivorship was evaluated using liner revision for wear/osteolysis as an endpoint using a Kaplan-Meier analysis.||||<0.001
73870606|NCT02508428|147285174|EQUIVALENCE|"Since the null hypothesis assumed that the wear rates were not different, Equivalence has been specified for the Type of Statistical Test"|Mean Difference (Net)|0.22|||<|0.001|TWO_SIDED|95.0|0.17|0.27||A p-value of 0.05 was used as the threshold for statistical significance.|t-test, 2 sided|||||0.27|0.17|<0.001
73870607|NCT02508428|147285175|EQUIVALENCE|"Since the null hypothesis assumed that the incidences of clinically important osteolysis were not different, Equivalence has been specified for the Type of Statistical Test"|Risk Ratio (RR)|0.04|||<|0.001|TWO_SIDED|95.0|0.006|0.3||A p-value of 0.05 was used as the threshold for statistical significance.|Fisher Exact|||||0.30|0.006|<0.001
73949036|NCT01302938|147431145|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.0|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-11.0|29.0||||||Change at Week 12; Total HRQL Score: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||29.0|-11.0|
73949037|NCT01302938|147431146|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|4.0|||||TWO_SIDED|95.0|-20.0|20.0||||||Change at Week 12; Social Subscale: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||20.00|-20.00|
73949038|NCT01233609|147431157|SUPERIORITY||Mean Difference (Net)|-150.43|STANDARD_ERROR_OF_MEAN|71.37||0.035|TWO_SIDED||||||Mixed Models Analysis|degrees of freedom = 830|Right eye and Left Eye within each of the 2 treatment groups (Placebo and Valproic Acid) were combined to estimate the difference|||||0.035
73949039|NCT01233609|147431158|SUPERIORITY|||||||0.581|||||||Mixed Models Analysis|||||||0.581
73949040|NCT01233609|147431159|SUPERIORITY|||||||0.409|||||||Wilcoxon (Mann-Whitney)|||||||0.409
73949041|NCT01233609|147431160|SUPERIORITY|||||||0.229|||||||Wilcoxon (Mann-Whitney)|||||||0.229
73949042|NCT02041923|147431185|EQUIVALENCE|A t-test was conducted to evaluate equivalency.|Mean Difference (Net)|46.3|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73949043|NCT00874432|147431212|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||p-value for CBPWV between CKD and Control groups||||0.685
73949044|NCT00874432|147431212|SUPERIORITY|||||||0.739|||||||t-test, 2 sided|||p-value for CRPWV between CKD and Control groups||||0.739
73977604|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-17.0|3.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||3.8|-17.0|
73977605|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-13.4|7.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||7.9|-13.4|
73949045|NCT00874432|147431212|SUPERIORITY|||||||0.471|||||||t-test, 2 sided|||p-value for CFPWV between CKD and Control groups||||0.471
73949046|NCT00874432|147431213|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||This p-value compares the baseline CBPWV measures for the CKD vs Controls group||||0.685
74032441|NCT05113953|147618070|SUPERIORITY||Treatment Difference|-0.06||||0.8502|TWO_SIDED|95.0|-0.69|0.57||P-value was analysed by MMRM method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, interaction term of treatment by visit week.|MMRM|||||0.57|-0.69|0.8502
74032442|NCT05113953|147618071|SUPERIORITY||Treatment Difference|-0.54||||0.0313|TWO_SIDED|95.0|-1.02|-0.05||P-value was analysed by MMRM method with change from baseline value as dependent variable and included treatment, trial center, visit week, treatment-by-week interaction as fixed effects and baseline-by-week interaction as covariates.|MMRM|||Change from baseline at Week 8||-0.05|-1.02|0.0313
73949047|NCT00874432|147431213|SUPERIORITY|||||||0.869|||||||t-test, 2 sided|||This p-value compares the 12 month CBPWV measures for the CKD vs Controls group||||0.869
73949048|NCT00874432|147431213|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||This p-value compares the baseline CRPWV measures for the CKD vs Controls group||||0.709
73949049|NCT00874432|147431213|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||This p-value compares the 12 month CBPWV measures for the CKD vs Controls group||||0.340
73949050|NCT00874432|147431213|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||This p-value compares the baseline CFPWV measures for the CKD vs Controls group||||0.730
73949051|NCT00874432|147431213|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||This p-value compares the 12 month CFPWV measures for the CKD vs Controls group||||0.204
73949052|NCT00874432|147431213|SUPERIORITY|||||||0.963|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure of ACE-I CKD and Control groups||||0.963
73949053|NCT00874432|147431213|SUPERIORITY|||||||0.991|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure of ACE-I CKD and Control groups||||0.991
73949054|NCT00874432|147431213|SUPERIORITY|||||||0.176|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure of ACE-I CKD and Control groups||||0.176
73949055|NCT00874432|147431213|SUPERIORITY|||||||0.402|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the ACE-I CKD||||0.402
73949056|NCT00874432|147431213|SUPERIORITY|||||||0.586|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the ACE-I CKD||||0.586
73949057|NCT00874432|147431213|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the ACE-I CKD||||0.455
73949058|NCT00874432|147431213|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the ACE-I Control Group||||0.418
73949059|NCT00874432|147431213|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the ACE-I Control Group||||0.091
73949060|NCT00874432|147431213|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the ACE-I Control Group||||0.034
73949061|NCT00874432|147431213|SUPERIORITY|||||||0.921|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure of the CKD and Control groups||||0.921
73949062|NCT00874432|147431213|SUPERIORITY|||||||0.887|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure of the CKD and Control groups||||0.887
73949063|NCT00874432|147431213|SUPERIORITY|||||||0.759|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure of the CKD and Control groups||||0.759
73949064|NCT00874432|147431213|SUPERIORITY|||||||0.851|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the Control groups||||0.851
73949065|NCT00874432|147431213|SUPERIORITY|||||||0.733|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the Control groups||||0.733
73977606|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-17.6|3.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||3.7|-17.6|
73977607|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|95.0|-12.9|7.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||7.5|-12.9|
74032443|NCT05113953|147618071|SUPERIORITY||Treatment Difference|0.19||||0.4471|TWO_SIDED|95.0|-0.3|0.67||P-value was analysed by MMRM method with change from baseline value as dependent variable and included treatment, trial center, visit week, treatment-by-week interaction as fixed effects and baseline-by-week interaction as covariates.|MMRM|||Change from baseline at Week 8||0.67|-0.30|0.4471
74032444|NCT00502307|147618094|OTHER||Exact binomial distribution|24.6|||||TWO_SIDED|95.0|19.6|30.2||||||||30.2|19.6|
74032445|NCT00502307|147618094|OTHER||Exact binomial distribution|18.0|||||TWO_SIDED|95.0|13.6|23.1||||||||23.1|13.6|
74032446|NCT00502307|147618095|OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
74032447|NCT00502307|147618095|OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
74032448|NCT00502307|147618096|OTHER|||||||0.005|||||||Log Rank|||||||0.005
74032449|NCT00502307|147618096|OTHER|||||||0.129|||||||Log Rank|||||||0.129
74032450|NCT00502307|147618097|OTHER|||||||0.003|||||||Log Rank|||||||0.003
74032451|NCT00502307|147618097|OTHER|||||||0.089|||||||Log Rank|||||||0.089
74032452|NCT04102098|147618133|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.012|TWO_SIDED|95.0|0.56|0.93|||Log Rank|||Stratification factors include geographic region (Asia Pacific excluding Japan vs. rest of world) and High risk features/curative procedure (Ablation vs. Resection with 1 high risk feature vs. Resection with 2 or more high risk features).||0.93|0.56|0.0120
74032453|NCT04742907|147618145|SUPERIORITY||Cox Proportional Hazard|0.91||||0.767|TWO_SIDED|90.0|0.74|1.12||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: hazard ratio (HR) = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and confidence intervals (CIs) are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|||1.12|0.74|0.767
74032454|NCT04742907|147618145|SUPERIORITY||Cox Proportional Hazard|1.17||||0.107|TWO_SIDED|90.0|0.95|1.44||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|||1.44|0.95|0.107
74032455|NCT04742907|147618146|SUPERIORITY||Cox Proportional Hazard|0.9||||0.78|TWO_SIDED|90.0|0.71|1.13||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to GI-2||1.13|0.71|0.780
73949066|NCT00874432|147431213|SUPERIORITY|||||||0.902|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the Control groups||||0.902
73949067|NCT00874432|147431213|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure between the CKD ACE-I and CKD Control groups.||||0.414
73949068|NCT00874432|147431213|SUPERIORITY|||||||0.942|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure between the CKD ACE-I and CKD Control groups.||||0.942
73949069|NCT00874432|147431213|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure between the CKD ACE-I and CKD Control groups.||||0.990
73949070|NCT00874432|147431213|SUPERIORITY|||||||0.273|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure between the ACE-I Control and CKD Control groups.||||0.273
73949071|NCT00874432|147431213|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure between the ACE-I Control and CKD Control groups.||||0.516
73949072|NCT00874432|147431213|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure between the ACE-I Control and CKD Control groups.||||0.102
73949073|NCT01518946|147431215|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|521.0||||0.0131|TWO_SIDED|95.0|124.2|917.7|||ANOVA|||||917.7|124.2|0.0131
73949074|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.8|3.9||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||3.9|-3.8|
73949075|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.5||||||95.0|-7.1|3.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||3.7|-7.1|
73949076|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.1||||||95.0|-13.4|5.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||5.1|-13.4|
73949077|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.3||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.3|-3.2|
73949078|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.1||||||95.0|-4.5|7.1||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 17 EU/mL threshold was calculated||7.1|-4.5|
73949079|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.2|-3.2|
73949080|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||3.2|-3.2|
73949081|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.5||||||95.0|-7.9|4.8||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated||4.8|-7.9|
73949082|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.2|-3.2|
73949083|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-3.1||||||95.0|-10.0|3.4||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 15 EU/mL threshold was calculated||3.4|-10.0|
73949084|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.7||||||95.0|-0.5|7.6||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 2.2 EU/mL threshold was calculated||7.6|-0.5|
73949085|NCT00384059|147431216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.0||||||95.0|-4.1|6.5||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||6.5|-4.1|
73949086|NCT00384059|147431217|SUPERIORITY_OR_OTHER||Difference|-5.3||||||95.0|-19.7|8.8||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||8.8|-19.7|
73949087|NCT00384059|147431217|SUPERIORITY_OR_OTHER||Difference|-0.1||||||95.0|-8.0|8.1||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||8.1|-8.0|
73949088|NCT00384059|147431218|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.5|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||3.8|-3.5|
73977608|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|5.31|||TWO_SIDED|95.0|-15.4|5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||5.4|-15.4|
73977609|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|5.15|||TWO_SIDED|95.0|-14.3|5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||5.9|-14.3|
73977610|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|5.24|||TWO_SIDED|95.0|-14.2|6.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||6.4|-14.2|
73977611|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.17|||TWO_SIDED|95.0|-10.7|9.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||9.6|-10.7|
73977612|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|5.24|||TWO_SIDED|95.0|-14.8|5.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||5.7|-14.8|
73977613|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|5.23|||TWO_SIDED|95.0|-13.1|7.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||7.4|-13.1|
73949089|NCT00384059|147431218|SUPERIORITY_OR_OTHER||Difference|-1.0||||||95.0|-5.3|2.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||2.8|-5.3|
73949090|NCT00384059|147431219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.68|1.16||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.68|
73949091|NCT00384059|147431220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.54|1.08||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.54|
73949092|NCT00384059|147431221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.82|1.16||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.82|
73949093|NCT00384059|147431221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.83|1.17||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.83|
73949094|NCT00384059|147431221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.8|1.26||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.26|0.80|
73949095|NCT00384059|147431221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.23||||||For Pertussis FIM the GMC ratio (13vPnC/7vPnC) was calculated||1.23|0.81|
73949096|NCT00384059|147431222|SUPERIORITY_OR_OTHER||Ratio|1.13||||||95.0|0.83|1.53||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.53|0.83|
73949097|NCT00384059|147431227|SUPERIORITY_OR_OTHER||Ration|0.85||||||95.0|0.48|1.49||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated||1.49|0.48|
73949098|NCT00405353|147431239|OTHER||||||<|0.05|||||||Mixed Models Analysis|Linear regressions were used to determine slopes of brain volume changes. Statistical software package SAS was used to perform the analysis.||Percent change in brain volume against time scatter plot with a Loess regression curve was produced and a first-degree spline model was developed. This model fitted line pieces for pre-treatment and early treatment periods (month -6 to month 3) and treatment response period (months 3-12), and these pieces were joined together to achieve continuity. Slopes of these lines were estimated and compared. A random intercept was set in the model to allow the difference among subjects.||||<0.05
73949099|NCT00649389|147431260|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
73949100|NCT00649389|147431260|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
73949101|NCT00649389|147431260|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
73949102|NCT00649389|147431261|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
73949103|NCT00649389|147431261|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
73949104|NCT00649389|147431261|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
73949105|NCT00649389|147431262|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
73949106|NCT00649389|147431262|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
73949107|NCT00649389|147431262|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||0.0001
73949108|NCT00649389|147431262|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
73977614|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|5.33|||TWO_SIDED|95.0|-14.1|6.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||6.8|-14.1|
73977615|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-13.5|7.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||7.3|-13.5|
73977616|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|95.0|-14.6|6.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||6.5|-14.6|
73949109|NCT00649389|147431262|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
73949110|NCT00649389|147431262|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
73977617|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|5.25|||TWO_SIDED|95.0|-12.6|8.0|||ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||8.0|-12.6|
73977618|NCT02434328|147501061|OTHER|Treatment difference|Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-13.6|7.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||7.7|-13.6|
73949111|NCT00649389|147431263|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
73949112|NCT00649389|147431263|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
73949113|NCT00649389|147431263|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
73949114|NCT02444988|147431268|SUPERIORITY||Odds Ratio (OR)|0.87|||<|0.05|TWO_SIDED|95.0|0.77|0.99|||Regression, Logistic|||||0.99|0.77|<0.05
73977619|NCT02434328|147501062|OTHER||Difference in proportions|-6.6|||||TWO_SIDED|95.0|-13.2|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-0.3|-13.2|
73949115|NCT02444988|147431269|SUPERIORITY||Odds Ratio (OR)|0.84|||<|0.05|TWO_SIDED|95.0|0.73|0.97|||Regression, Logistic|||||0.97|0.73|<0.05
73949116|NCT01984424|147431270|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED|95.0|-42.31|-33.28|||Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.28|-42.31|<0.0001
73949117|NCT01984424|147431271|SUPERIORITY||LS Mean Treatment Difference|-36.07|STANDARD_ERROR_OF_MEAN|2.53|<|0.0001|TWO_SIDED|95.0|-41.07|-31.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-31.08|-41.07|<0.0001
73949118|NCT01984424|147431272|SUPERIORITY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|95.0|-84.7|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-67.0|-84.7|<0.0001
73949119|NCT01984424|147431273|SUPERIORITY||LS Mean Treatment Difference|-71.7|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001|TWO_SIDED|95.0|-81.3|-62.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-62.2|-81.3|<0.0001
73949120|NCT01984424|147431274|SUPERIORITY||Treatment Difference|28.5|||<|0.0001|TWO_SIDED|95.0|19.1|36.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).||||36.7|19.1|<0.0001
73949121|NCT01984424|147431275|SUPERIORITY||Treatment Difference|27.4|||<|0.0001|TWO_SIDED|95.0|17.7|36.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).||||36.1|17.7|<0.0001
73949122|NCT01984424|147431276|SUPERIORITY||LS Mean Treatment Difference|-26.61|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-29.95|-23.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-23.27|-29.95|<0.0001
73949123|NCT01984424|147431277|SUPERIORITY||LS Mean Treatment Difference|-25.08|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED|95.0|-28.67|-21.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-21.48|-28.67|<0.0001
73949124|NCT01984424|147431278|SUPERIORITY||LS Mean Treatment Difference|-33.06|STANDARD_ERROR_OF_MEAN|2.06|<|0.0001|TWO_SIDED|95.0|-37.12|-28.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-28.99|-37.12|<0.0001
73949125|NCT01984424|147431279|SUPERIORITY||LS Mean Treatment Difference|-31.1|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001|TWO_SIDED|95.0|-35.44|-16.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-16.76|-35.44|<0.0001
73949126|NCT01984424|147431280|SUPERIORITY||LS Mean Treatment Difference|-33.86|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-38.15|-29.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-29.58|-38.15|<0.0001
73949127|NCT01984424|147431281|SUPERIORITY||LS Mean Treatment Difference|-31.75|STANDARD_ERROR_OF_MEAN|2.33|<|0.0001|TWO_SIDED|95.0|-36.35|-27.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-27.16|-36.35|<0.0001
73977620|NCT02434328|147501062|OTHER||Difference in proportions|-8.5|||||TWO_SIDED|95.0|-13.8|-3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-3.0|-13.8|
73949128|NCT01984424|147431282|SUPERIORITY||LS Mean Treatment Difference|-29.91|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-34.06|-25.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-25.77|-34.06|<0.0001
73870608|NCT02508428|147285176|EQUIVALENCE|"Since the null hypothesis assumed that the rate of satisfaction among the groups were not different, Equivalence has been specified for the Type of Statistical Test"||||||0.48||||||A p-value of 0.05 was used as the threshold for statistical significance.|Fisher Exact|||Since there were no patients with Marathon liners who were unsatisfied with the outcome of their hip replacement, a relative risk and the associated confidence interval could not be calculated.||||0.48
73870609|NCT02508428|147285177|EQUIVALENCE|"Since the null hypothesis assumed that the Harris Hip Scores among the groups were not different, Equivalence has been specified for the Type of Statistical Test"||||||0.4||||||A p-value of 0.05 was used as the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||.40
73870610|NCT02748070|147285178|OTHER|||||||0.819|||||||t-test, 2 sided|||Comparison of baseline and 1 week||||0.819
73977621|NCT02434328|147501062|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.2|-1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.7|-12.2|
73977622|NCT02434328|147501062|OTHER||Difference in proportions|-14.2|||||TWO_SIDED|95.0|-20.8|-8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-8.3|-20.8|
73977623|NCT02434328|147501062|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-2.9|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.6|-2.9|
73977624|NCT02434328|147501062|OTHER||Difference in proportions|-19.2|||||TWO_SIDED|95.0|-25.5|-13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-13.0|-25.5|
73977625|NCT02434328|147501062|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.6|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||-0.4|-11.6|
73977626|NCT02434328|147501062|OTHER||Difference in proportions|-9.8|||||TWO_SIDED|95.0|-16.5|-3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-3.5|-16.5|
74089290|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0173|TWO_SIDED|95.0|1.14|3.72|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.14|0.0173
73977627|NCT02434328|147501062|OTHER||Difference in proportions|-8.0|||||TWO_SIDED|95.0|-13.6|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.5|-13.6|
73870611|NCT02748070|147285178|OTHER|||||||0.665|||||||t-test, 2 sided|||Comparison of baseline and 1 month||||0.665
73870612|NCT02748070|147285178|OTHER|||||||0.071|||||||t-test, 2 sided|||Comparison of baseline and 3 months||||0.071
73870613|NCT02748070|147285178|OTHER|||||||0.097|||||||t-test, 2 sided|||Comparison of baseline and 6 months||||0.097
73870614|NCT02748070|147285179|OTHER|||||||0.376|||||||t-test, 2 sided|||Comparison of baseline and 1 week||||0.376
73870615|NCT02748070|147285179|OTHER|||||||0.685|||||||t-test, 2 sided|||Comparison of baseline and 1 month||||0.685
73870616|NCT02748070|147285179|OTHER|||||||0.388|||||||t-test, 2 sided|||Comparison of baseline and 3 months||||0.388
73870617|NCT02748070|147285179|OTHER|||||||0.233|||||||t-test, 2 sided|||Comparison of baseline and 6 months||||0.233
73870618|NCT00928694|147285180|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true geometric mean ratios (GMRs) \[U.S./UK\] for the AUC(0 to infinity) and maximum plasma concentration (Cmax) of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval \[0.80, 1.25\]).|Geometric Mean Ratio|0.96||||||90.0|0.9|1.02||||||||1.02|0.90|
73870619|NCT00928694|147285181|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true GMRs \[U.S./UK\] for the AUC(0 to infinity) and Cmax of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval \[0.80, 1.25\]).|Geometric Mean Ratio|0.98||||||90.0|0.9|1.06||||||||1.06|0.90|
73977628|NCT02434328|147501062|OTHER||Difference in proportions|-15.4|||||TWO_SIDED|95.0|-21.5|-9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-9.4|-21.5|
73977629|NCT02434328|147501062|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-3.2|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||8.4|-3.2|
73977630|NCT02434328|147501062|OTHER||Difference in proportions|-15.9|||||TWO_SIDED|95.0|-22.4|-10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-10.4|-22.4|
73977631|NCT02434328|147501062|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-8.5|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.1|-8.5|
73977632|NCT02434328|147501062|OTHER||Difference in proportions|-9.0|||||TWO_SIDED|95.0|-15.7|-2.9|||Regression, Logistic|Hypothesis testing not pre-specified.|Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-2.9|-15.7|
73977633|NCT02434328|147501062|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-9.8|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||2.2|-9.8|
73977634|NCT02434328|147501062|OTHER||Difference in proportions|-15.1|||||TWO_SIDED|95.0|-21.3|-8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-8.4|-21.3|
73977635|NCT02434328|147501062|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-6.1|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.2|-6.1|
73977636|NCT02434328|147501062|OTHER||Difference in proportions|-16.6|||||TWO_SIDED|95.0|-22.6|-10.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-10.5|-22.6|
73977637|NCT02434328|147501062|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-7.0|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.1|-7.0|
73977638|NCT02434328|147501062|OTHER||Difference in proportions|-11.0|||||TWO_SIDED|95.0|-17.4|-5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-5.0|-17.4|
73977639|NCT02434328|147501062|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-11.3|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.7|-11.3|
73977640|NCT02434328|147501062|OTHER||Difference in proportions|-12.0|||||TWO_SIDED|95.0|-18.9|-5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-5.9|-18.9|
73977641|NCT02434328|147501062|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-11.4|0.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||0.0|-11.4|
73977642|NCT02434328|147501062|OTHER||Difference in proportions|-14.5|||||TWO_SIDED|95.0|-20.3|-8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-8.3|-20.3|
73977643|NCT02434328|147501063|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.5|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.4|-2.5|
73977644|NCT02434328|147501063|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-6.1|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.7|-6.1|
73977645|NCT02434328|147501063|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-5.3|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-5.3|
73977646|NCT02434328|147501063|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-4.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.4|-4.5|
73870620|NCT00534976|147285182|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-4.65||||0.02||95.0|||||ANOVA||Montelukast minus placebo|||||0.020
73870621|NCT00534976|147285183|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-4.33||||0.005||95.0|||||ANOVA||Montelukast minus placebo|||||0.005
73870622|NCT00534976|147285184|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-120.86||||0.022||95.0|||||ANOVA||Montelukast minus placebo|||||0.022
73870623|NCT00534976|147285185|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-122.82||||0.013||95.0|||||ANOVA||Montelukast minus placebo|||||0.013
73870624|NCT00534976|147285186|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-8.27||||0.064||95.0|||||ANOVA||Montelukast minus placebo|||||0.064
73977647|NCT02434328|147501063|OTHER||Difference in proportions|8.2|||||TWO_SIDED|95.0|3.9|12.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||12.8|3.9|
74089291|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0118|TWO_SIDED|95.0|1.11|2.35|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.35|1.11|0.0118
73977648|NCT02434328|147501063|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-7.9|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||1.2|-7.9|
73977649|NCT02434328|147501063|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.0|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.4|-1.0|
73977650|NCT02434328|147501063|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.5|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.0|-5.5|
73977651|NCT02434328|147501063|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-5.6|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.8|-5.6|
73870625|NCT00534976|147285187|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-7.06||||0.054||95.0|||||ANOVA||Montelukast minus Placebo|||||0.054
73870626|NCT00534976|147285188|SUPERIORITY_OR_OTHER_LEGACY||Difference in Proportions|-1.6||||1||95.0||||P-value provided is for comparison between the two proportions: Montelukast versus placebo.|McNemar||Montelukast minus placebo|||||1.000
73870627|NCT00534976|147285189|SUPERIORITY_OR_OTHER_LEGACY||Difference in Proportions|-3.2||||||95.0|||||||Montelukast minus placebo|||||
73870628|NCT00799266|147285217|SUPERIORITY|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|0.414||||0.0392|TWO_SIDED|95.0|0.022|0.806|||ANCOVA|||Lumbar Spine BMD Z-score at Month 12||0.806|0.022|0.0392
73870629|NCT00799266|147285218|SUPERIORITY|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|0.29||||0.1322|TWO_SIDED|95.0|-0.094|0.673|||ANCOVA|||Lumbar Spine BMD Z-score at Month 6||0.673|-0.094|0.1322
73870630|NCT00799266|147285219|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|1.979||||0.0409|TWO_SIDED|95.0|0.089|3.869|||ANCOVA|||Lumbar Spine BMC at Month 6||3.869|0.089|0.0409
73870631|NCT00799266|147285219|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|2.155||||0.234|TWO_SIDED|95.0|-1.488|5.798|||ANCOVA|||Lumbar Spine BMC at Month 12||5.798|-1.488|0.2340
73870632|NCT00799266|147285220|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|34.058||||0.3827|TWO_SIDED|95.0|-45.385|113.502|||ANCOVA|||Total Body BMC at Month 6||113.502|-45.385|0.3827
73870633|NCT00799266|147285220|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|80.741||||0.2634|TWO_SIDED|95.0|-65.602|227.084|||ANCOVA|||Total Body BMC at Month 12||227.084|-65.602|0.2634
73870634|NCT00799266|147285221|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-211.782||||0.0631|TWO_SIDED|95.0|-363.765|-59.8|||ANCOVA|||Serum P1NP at Month 6||-59.800|-363.765|0.0631
73870635|NCT00799266|147285221|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-381.132||||0.0049|TWO_SIDED|95.0|-565.416|-196.848|||ANCOVA|||Serum P1NP at Month 12||-196.848|-565.416|0.0049
73870636|NCT00799266|147285222|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-11.223||||0.2129|TWO_SIDED|95.0|-22.595|0.149|||ANCOVA|||Serum BSAP at Month 6||0.149|-22.595|0.2129
73870637|NCT00799266|147285222|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-20.435||||0.0215|TWO_SIDED|95.0|-33.96|-6.909|||ANCOVA|||Serum BSAP at Month 12||-6.909|-33.960|0.0215
73870638|NCT00799266|147285223|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-20.938||||0.0254|TWO_SIDED|95.0|-33.766|-8.11|||ANCOVA|||Serum NTX at Month 6||-8.110|-33.766|0.0254
73870639|NCT00799266|147285223|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-27.574||||0.0002|TWO_SIDED|95.0|-39.037|-16.111|||ANCOVA|||Serum NTX at Month 12||-16.111|-39.037|0.0002
73949129|NCT01984424|147431283|SUPERIORITY||LS Mean Treatment Difference|-27.2|STANDARD_ERROR_OF_MEAN|2.22|<|0.0001|TWO_SIDED|95.0|-31.58|-22.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-22.82|-31.58|<0.0001
73949130|NCT01984424|147431284|SUPERIORITY||LS Mean Treatment Difference|-34.13|STANDARD_ERROR_OF_MEAN|2.26|<|0.0001|TWO_SIDED|95.0|-38.59|-29.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-29.67|-38.59|<0.0001
73949131|NCT01984424|147431285|SUPERIORITY||LS Mean Treatment Difference|-31.98|STANDARD_ERROR_OF_MEAN|2.36|<|0.0001|TWO_SIDED|95.0|-36.64|-27.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-27.32|-36.64|<0.0001
73949132|NCT01984424|147431286|SUPERIORITY||LS Mean Treatment Difference|-21.08|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|95.0|-27.65|-14.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-14.51|-27.65|<0.0001
73977652|NCT02434328|147501063|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-6.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.1|-6.0|
73977653|NCT02434328|147501063|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-0.5|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||8.0|-0.5|
73977654|NCT02434328|147501063|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-6.2|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.2|-6.2|
73977655|NCT02434328|147501063|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.5|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.1|-2.5|
73977656|NCT02434328|147501063|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.1|-5.9|
73977657|NCT02434328|147501063|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.4|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.4|-4.4|
73977658|NCT02434328|147501063|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-6.2|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||2.1|-6.2|
73977659|NCT02434328|147501063|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.5|-1.2|
73977660|NCT02434328|147501063|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.2|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.3|-4.2|
73977661|NCT02434328|147501063|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-3.5|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.2|-3.5|
73977662|NCT02434328|147501063|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-4.8|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||4.3|-4.8|
73949133|NCT01984424|147431287|SUPERIORITY||LS Mean Treatment Difference|-21.24|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001|TWO_SIDED|95.0|-28.42|-14.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-14.05|-28.42|<0.0001
73949134|NCT01984424|147431288|SUPERIORITY||LS Mean Treatment Difference|-4.44|STANDARD_ERROR_OF_MEAN|4.72||0.37|TWO_SIDED|95.0|-13.74|4.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||4.87|-13.74|0.37
73949135|NCT01984424|147431289|SUPERIORITY||LS Mean Treatment Difference|-1.82|STANDARD_ERROR_OF_MEAN|6.0||0.37|TWO_SIDED|95.0|-13.64|10.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||10.01|-13.64|0.37
73949136|NCT01984424|147431290|SUPERIORITY||LS Mean Treatment Difference|6.18|STANDARD_ERROR_OF_MEAN|2.05||0.0083|TWO_SIDED|95.0|2.15|10.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||10.22|2.15|0.0083
73949137|NCT01984424|147431291|SUPERIORITY||LS Mean Treatment Difference|4.5|STANDARD_ERROR_OF_MEAN|2.27||0.0083|TWO_SIDED|95.0|0.02|8.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||8.98|0.02|0.0083
73949138|NCT01984424|147431292|SUPERIORITY||LS Mean Treatment Difference|-4.65|STANDARD_ERROR_OF_MEAN|3.85||0.37|TWO_SIDED|95.0|-12.25|2.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||2.94|-12.25|0.37
73949139|NCT01984424|147431293|SUPERIORITY||LS Mean Treatment Difference|-1.23|STANDARD_ERROR_OF_MEAN|4.67||0.37|TWO_SIDED|95.0|-10.45|7.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||7.98|-10.45|0.37
73949140|NCT00077636|147431296|NON_INFERIORITY_OR_EQUIVALENCE|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.76|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.||||0.76|0.46|<.0001
73949141|NCT00077636|147431297|NON_INFERIORITY_OR_EQUIVALENCE|In the analysis based on the standard population, end of treatment virological response was equivalent in the two treatment arms (94% in the 16-week arm and 92% in the 24-week arm).|Odds Ratio (OR)|1.32||||0.1941|TWO_SIDED|95.0|0.86|2.03|||Cochran-Mantel-Haenszel|stratified by country.||||2.03|0.86|0.1941
73949142|NCT00077636|147431298|NON_INFERIORITY_OR_EQUIVALENCE|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.65||||0.0003|TWO_SIDED|95.0|0.52|0.82|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.||||0.82|0.52|0.0003
73949143|NCT01993017|147431339|SUPERIORITY|||||||0.98||||||A 2-step gatekeeping test procedure was used. An omnibus F test using ANOVA comparing the 3 groups was first performed. Pairwise comparisons using a 2-sided t test at 5% nominal significance were planned only if the omnibus F test had a P value \<.05.|ANOVA|||We determined that a sample size per group of 500, assuming 5% loss to follow-up, would yield 80% power for a 2-sided t test at the 5% level. These calculations were based on an assumed SD for QALYs of 0.17, expected prevalence of screening-detected depression of 20%, and assumed net improvement in QALYs of 0.155 over 18 months for individuals with depression who received treatment for depression in the Screen, Notify, and Treat group.||||0.98
73949144|NCT00999661|147431369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.8|STANDARD_DEVIATION|25.12|<|0.0001||95.0|36.6|43.1||One-sample t-test for change from baseline|t-test, 2 sided|||||43.1|36.6|<0.0001
73949145|NCT00999661|147431370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.6|STANDARD_DEVIATION|19.79|<|0.0001||95.0|34.0|39.2|||t-test, 2 sided|||||39.2|34.0|<0.0001
73949146|NCT00999661|147431371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|STANDARD_DEVIATION|5.233|<|0.0001||95.0|-8.65|-7.29|||t-test, 2 sided|||||-7.29|-8.65|<0.0001
73949147|NCT00917267|147431372|NON_INFERIORITY_OR_EQUIVALENCE|Superiority of exenatide once weekly to exenatide twice daily concluded if upper limit of the 2-sided 95% confidence interval for treatment difference is \<0; noninferiority concluded if upper limit is \<0.4%.|Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||Mixed Models Analysis|||MMRM analysis of covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects. Power: 306 patients per treatment group provides approximately 98% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||-0.14|-0.49|<.001
73949148|NCT00917267|147431373|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target \<=7% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which country and background OAD served as the stratification factors.||||0.003
73949149|NCT00917267|147431374|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target \<=6.5% at Week 26 were compared between treatments using a CMH test, in which country and background OAD served as the stratification factors.||||<.001
73949150|NCT00917267|147431375|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.67|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-22.5|-10.83|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline FSG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||-10.83|-22.50|<.001
73949151|NCT00917267|147431376|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.39|1.25|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline BW, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.25|0.39|<.001
73949152|NCT00917267|147431377|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|2.56||0.609|TWO_SIDED|95.0|-6.33|3.71|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline TC, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||3.71|-6.33|0.609
73949153|NCT00917267|147431378|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.52||0.476|TWO_SIDED|95.0|-0.65|1.38|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline HDL, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.38|-0.65|0.476
73949154|NCT00917267|147431379|SUPERIORITY_OR_OTHER||Geometic Least Squares Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.807|TWO_SIDED|95.0|0.93|1.06|||Mixed Models Analysis|||TG data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM ANCOVA model with treatment, baseline TG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.06|0.93|0.807
73977663|NCT02434328|147501063|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-3.3|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.2|-3.3|
73949155|NCT02960763|147431388|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.01||||||Equivalence of group|ANOVA|||||||0.010
73949156|NCT02960763|147431388|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.004||||||augment with aripiprazole vs switch to bupropion|ANOVA|||||||0.004
73949157|NCT02960763|147431388|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.017||||||augment with bupropion vs switch to bupropion|ANOVA|||||||0.017
73949158|NCT02960763|147431388|SUPERIORITY|||||||0.65|||||||ANOVA|||Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||0.650
73949159|NCT02960763|147431388|SUPERIORITY|||||||0.003||||||augmentation versus switch|ANOVA|||Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||0.003
73949160|NCT02960763|147431388|SUPERIORITY|For those who proceed to Step 2, analogous repeated measures 2\*2\*2 ANOVA will be used with a significance level of .05 for the time\*treatment group comparison.||||||0.385|||||||ANOVA|||||||0.385
73949161|NCT02960763|147431389|SUPERIORITY|||||||0.038||||||Group effect|generalized linear model with logistic l|||||||0.038
73949162|NCT02960763|147431389|SUPERIORITY|||||||0.021||||||augmentation with aripiprazole vs switch to bupropion|generalized linear model with logistic l|||||||0.021
73949163|NCT02960763|147431389|SUPERIORITY|||||||0.027||||||augmentation with bupropion vs switch to bupropion|generalized linear model with logistic l|||||||0.027
73949164|NCT02960763|147431389|SUPERIORITY|||||||0.934||||||Augmentation with aripiprazole v augmentation with bupropion|generalized linear model with logistic l|||||||0.934
73949165|NCT02960763|147431389|SUPERIORITY|||||||0.011||||||augmentation versus switch|generalized linear model with logistic l|||||||0.011
73949166|NCT02960763|147431389|SUPERIORITY|||||||0.5|||||||generalized linear model with logistic l|||||||0.500
73949167|NCT02960763|147431390|SUPERIORITY|||||||0.164||||||Cox models time to event comparing treatment arms.|Regression, Cox|||||||0.164
73949168|NCT02960763|147431390|SUPERIORITY|||||||0.103|||||||Regression, Cox|||||||0.103
73949169|NCT02960763|147431390|SUPERIORITY|||||||0.127|||||||Regression, Cox|||||||0.127
73949170|NCT02960763|147431390|SUPERIORITY|||||||0.524||||||Cox models to examine time to event comparing treatment arms.|Regression, Cox|||||||0.524
73949171|NCT00312858|147431393|NON_INFERIORITY_OR_EQUIVALENCE|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference of seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \>-10.0).|Risk Difference (RD)|0.7|||<|0.001||95.0|-1.4|3.8||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 - Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2.||3.8|-1.4|<0.001
73949172|NCT00312858|147431394|NON_INFERIORITY_OR_EQUIVALENCE|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \>-10.0).|Risk Difference (RD)|-5.1||||0.013||95.0|-9.3|-1.4||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided multiplicity-adjusted α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 - Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2 for participants with initial serostatus \<1.25 gpELISA units/mL||-1.4|-9.3|0.013
74032456|NCT04742907|147618146|SUPERIORITY||Cox Proportional Hazard|1.06||||0.33|TWO_SIDED|90.0|0.84|1.34||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to GI-2||1.34|0.84|0.330
73870640|NCT00799266|147285224|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-1.874||||0.2178|TWO_SIDED|95.0|-3.931|0.182|||ANCOVA|||Serum TRAP-5b at Month 6||0.182|-3.931|0.2178
73870641|NCT00799266|147285224|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-1.837||||0.184|TWO_SIDED|95.0|-4.103|0.429|||ANCOVA|||Serum TRAP-5b at Month 12||0.429|-4.103|0.1840
73870642|NCT00799266|147285225|OTHER|The number and percentage of patients with new vertebral fractures at Month 12 were presented by treatment group and between-treatment differences were evaluated using Fisher's exact test.||||||0.2258|||||||Fisher Exact|||New vertebral fractures at Month 12||||0.2258
74032457|NCT04742907|147618146|SUPERIORITY||Cox Proportional Hazard|0.9||||0.788|TWO_SIDED|90.0|0.73|1.11||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to first toleration of clear liquids||1.11|0.73|0.788
74032458|NCT04742907|147618146|SUPERIORITY||Cox Proportional Hazard|1.22||||0.055|TWO_SIDED|90.0|0.99|1.51||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to first toleration of clear liquids||1.51|0.99|0.055
74032459|NCT04742907|147618146|SUPERIORITY||Cox Proportional Hazard|1.07||||0.306|TWO_SIDED|90.0|0.86|1.32||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to absence of distension and presence of bowel sounds and flatus||1.32|0.86|0.306
74032460|NCT04742907|147618146|SUPERIORITY||Cox Proportional Hazard|1.09||||0.243|TWO_SIDED|90.0|0.88|1.35||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to absence of distension and presence of bowel sounds and flatus||1.35|0.88|0.243
73949173|NCT00312858|147431395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 4||1.3|0.9|<0.001
74032461|NCT04742907|147618147|SUPERIORITY||Cox Proportional Hazard|1.0||||0.489|TWO_SIDED|90.0|0.81|1.24||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to ready for discharge||1.24|0.81|0.489
74032462|NCT04742907|147618147|SUPERIORITY||Cox Proportional Hazard|1.15||||0.138|TWO_SIDED|90.0|0.93|1.42||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to ready for discharge||1.42|0.93|0.138
74089292|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0132|TWO_SIDED|95.0|1.1|2.32|||Regression, Logistic|||Week 8, \>=30%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.32|1.10|0.0132
73870643|NCT00799266|147285226|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-0.018||||0.318|TWO_SIDED|95.0|-0.055|0.019|||ANCOVA|||Vertebral morphometry at Month 12||0.019|-0.055|0.3180
73870644|NCT00799266|147285227|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.5226|TWO_SIDED|95.0|0.04|5.2|||Regression, Logistic|||Reduction in Pain at Month 3||5.20|0.04|0.5226
73870645|NCT00799266|147285227|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|999.99||||0.522|TWO_SIDED|95.0|0.01|999.99||\>999.99 (\<0.01, \>999.99)|Regression, Logistic|||Reduction in Pain at Month 6||999.99|0.01|0.5220
73870646|NCT00799266|147285227|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.52||||0.6019|TWO_SIDED|95.0|0.04|6.22|||Regression, Logistic|||Reduction in Pain at Month 9||6.22|0.04|0.6019
73870647|NCT00799266|147285227|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.9652|TWO_SIDED|0.9652|0.01|999.99||0.45 (\<0.01, \>999.99)|Regression, Logistic|||Reduction in Pain at Month 12||999.99|0.01|0.9652
73870648|NCT00799266|147285228|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-0.04||||0.5165|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||2nd metacarpal cortical width at Month 12||0.09|-0.17|0.5165
74032463|NCT04742907|147618147|SUPERIORITY||Cox Proportional Hazard|1.01||||0.473|TWO_SIDED|90.0|0.82|1.24||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to discharge order written||1.24|0.82|0.473
73949174|NCT00312858|147431395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|TWO_SIDED|95.0|0.8|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 6B||1.2|0.8|<0.001
74032464|NCT04742907|147618147|SUPERIORITY||Cox Proportional Hazard|1.24||||0.045|TWO_SIDED|90.0|1.01|1.53||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to discharge order written||1.53|1.01|0.045
73949175|NCT00312858|147431395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|0.9|||<|0.001|TWO_SIDED|95.0|0.8|1.0|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 9V||1.0|0.8|<0.001
73949176|NCT00312858|147431395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 14||1.2|0.9|<0.001
73949177|NCT00312858|147431395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 18C||1.3|0.9|<0.001
73949178|NCT00312858|147431395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 19F||1.2|0.9|<0.001
73949179|NCT00312858|147431395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|1.0|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 23F||1.3|1.0|<0.001
73949180|NCT00252590|147431442|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||ANOVA|||||||0.32
73949181|NCT01863043|147431548|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
73949182|NCT01863043|147431549|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
73949183|NCT01863043|147431550|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||||||0.28
73949184|NCT01863043|147431551|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
73949185|NCT01863043|147431552|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
73949186|NCT01863043|147431553|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
73949187|NCT01863043|147431554|SUPERIORITY|||||||0.59|||||||Accelerated failure time regression mode|||||||0.59
73949188|NCT01863043|147431555|SUPERIORITY|||||||0.64|||||||Accelerated failure time regression mode|||||||0.64
73949189|NCT01863043|147431556|SUPERIORITY|||||||0.95|||||||Accelerated failure time regression mode|||||||0.95
73949190|NCT01863043|147431557|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
73949191|NCT01863043|147431558|SUPERIORITY|||||||0.23|||||||Accelerated failure time regression mode|||||||0.23
73949192|NCT01863043|147431559|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
73949193|NCT01863043|147431560|SUPERIORITY|||||||0.01|||||||Accelerated failure time regression mode|||||||0.01
73949194|NCT01863043|147431561|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
73949195|NCT01863043|147431562|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
73949196|NCT01863043|147431564|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
73949197|NCT01863043|147431565|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
73949198|NCT01863043|147431566|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
73949199|NCT01863043|147431567|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
73949200|NCT01863043|147431568|SUPERIORITY|||||||0.694|||||||Wilcoxon (Mann-Whitney)|||||||0.694
73949201|NCT01863043|147431569|SUPERIORITY|||||||0.97|||||||Accelerated failure time regression mode|||||||0.97
73949202|NCT01863043|147431570|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||||||0.60
73949203|NCT01863043|147431571|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
73949204|NCT01863043|147431572|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
73949205|NCT01863043|147431573|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
73949206|NCT01863043|147431574|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
73949207|NCT01863043|147431575|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
73949208|NCT01863043|147431576|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|||||||0.59
73949209|NCT01863043|147431577|SUPERIORITY|||||||0.888|||||||Mixed Models Analysis|||||||0.888
73949210|NCT01863043|147431578|SUPERIORITY|||||||0.694|||||||Regression, Linear|||||||0.694
73949211|NCT01863043|147431579|SUPERIORITY|||||||0.248|||||||general linear mixed model|||||||0.248
74032465|NCT04742907|147618148|SUPERIORITY|||||||0.923||||||P-value is from two-sample t-test comparing TU-100 15 g/day treatment group versus placebo.|t-test, 2 sided|||||||0.923
74032466|NCT04742907|147618148|SUPERIORITY|||||||0.039||||||P-value is from two-sample t-test comparing TU-100 7.5 g/day treatment group versus placebo.|t-test, 2 sided|||||||0.039
73977664|NCT02434328|147501063|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.5|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.9|-4.5|
73977665|NCT02434328|147501063|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-0.1|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.0|-0.1|
74032467|NCT04742907|147618150|SUPERIORITY||Odds Ratio (OR)|0.79||||0.434|TWO_SIDED|95.0|0.44|1.42||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.42|0.44|0.434
73977666|NCT02434328|147501063|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.3|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.6|-4.3|
73977667|NCT02434328|147501064|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-8.9|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.5|-8.9|
73977668|NCT02434328|147501064|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-7.6|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.5|-7.6|
73977669|NCT02434328|147501064|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.9|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.7|-6.9|
73977670|NCT02434328|147501064|OTHER||Difference in proportions|-7.8|||||TWO_SIDED|95.0|-13.0|-2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.7|-13.0|
73977671|NCT02434328|147501064|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-3.6|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.2|-3.6|
73977672|NCT02434328|147501064|OTHER||Difference in proportions|-7.9|||||TWO_SIDED|95.0|-12.6|-3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.1|-12.6|
73977673|NCT02434328|147501064|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-6.8|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.7|-6.8|
73977674|NCT02434328|147501064|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-10.5|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-0.3|-10.5|
73977675|NCT02434328|147501064|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-10.3|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-0.4|-10.3|
73977676|NCT02434328|147501064|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-11.2|-0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.5|-11.2|
73977677|NCT02434328|147501064|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.8|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.6|-4.8|
73977678|NCT02434328|147501064|OTHER||Difference in proportions|-9.1|||||TWO_SIDED|95.0|-13.8|-3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-3.9|-13.8|
73977679|NCT02434328|147501064|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-7.1|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.5|-7.1|
73949212|NCT01863043|147431580|SUPERIORITY|||||||0.694|||||||general linear mixed model|||||||0.694
73949213|NCT01863043|147431581|SUPERIORITY|||||||0.195|||||||Regression, Linear|||||||0.195
73949214|NCT04250337|147431609|SUPERIORITY||Risk Difference (RD)|18.3||||0.011|TWO_SIDED|95.0|5.1|31.5|||Cochran-Mantel-Haenszel|||||31.5|5.1|0.011
73949215|NCT04250337|147431610|SUPERIORITY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|12.1|40.8|||Cochran-Mantel-Haenszel|||||40.8|12.1|<.001
73949216|NCT04250337|147431611|SUPERIORITY||Risk Difference (RD)|18.9||||0.008|TWO_SIDED|95.0|6.1|31.7|||Cochran-Mantel-Haenszel|||||31.7|6.1|0.008
73949217|NCT04250337|147431612|SUPERIORITY||LS Mean Difference (Final Values)|-15.21|STANDARD_ERROR_OF_MEAN|6.373||0.017263|TWO_SIDED|95.0|-27.7|-2.7|||ANCOVA|||||-2.7|-27.7|0.017263
73949218|NCT04250337|147431613|SUPERIORITY||Risk Difference (RD)|19.2||||0.017|TWO_SIDED|95.0|4.3|34.1|||Cochran-Mantel-Haenszel|||||34.1|4.3|0.017
73949219|NCT04250337|147431614|SUPERIORITY||Risk Difference (RD)|21.6||||0.007|TWO_SIDED|95.0|7.1|36.1|||Cochran-Mantel-Haenszel|||||36.1|7.1|0.007
73949220|NCT04250337|147431615|SUPERIORITY||LS Mean Difference (Final Values)|-23.64|STANDARD_ERROR_OF_MEAN|5.074||3e-06|TWO_SIDED|95.0|-33.6|-13.7|||ANCOVA|||||-13.7|-33.6|0.000003
73949221|NCT04250337|147431616|SUPERIORITY||LS Mean Difference (Final Values)|-12.28|STANDARD_ERROR_OF_MEAN|2.428|<|0.001|TWO_SIDED|95.0|-17.07|-7.49|||Mixed Models Analysis|||||-7.49|-17.07|<0.001
73949222|NCT04250337|147431617|SUPERIORITY||Risk Difference (RD)|3.5||||0.454|TWO_SIDED|95.0|-4.9|11.8|||Cochran-Mantel-Haenszel|||||11.8|-4.9|0.454
73949223|NCT04250337|147431618|SUPERIORITY||Markov Chain Monte Carlo (MCMC)|-20.14|STANDARD_ERROR_OF_MEAN|12.81||0.117607|TWO_SIDED|95.0|-45.4|5.1|||ANCOVA|||||5.1|-45.4|0.117607
73949224|NCT04250337|147431619|SUPERIORITY||Markov Chain Monte Carlo (MCMC)|-0.3|STANDARD_ERROR_OF_MEAN|0.134||0.025293|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.025293
73949225|NCT04250337|147431620|SUPERIORITY||Risk Difference (RD)|14.2||||0.022|TWO_SIDED|95.0|3.8|24.7|||Cochran-Mantel-Haenszel|||||24.7|3.8|0.022
73949226|NCT04250337|147431621|SUPERIORITY||Risk Difference (RD)|1.2||||0.764|TWO_SIDED|95.0|-7.3|9.7|||Cochran-Mantel-Haenszel|||||9.7|-7.3|0.764
73949227|NCT04250337|147431622|SUPERIORITY||Risk Difference (RD)|1.9||||0.498|TWO_SIDED|95.0|-2.9|6.7|||Cochran-Mantel-Haenszel|||||6.7|-2.9|0.498
73949228|NCT04250337|147431623|SUPERIORITY||Risk Difference (RD)|15.6||||0.014|TWO_SIDED|95.0|5.3|25.9|||Cochran-Mantel-Haenszel|||||25.9|5.3|0.014
73949229|NCT04250337|147431624|SUPERIORITY||Risk Difference (RD)|1.1||||0.818|TWO_SIDED|95.0|-8.0|10.2|||Cochran-Mantel-Haenszel|||||10.2|-8.0|0.818
73949230|NCT04250337|147431625|SUPERIORITY||Risk Difference (RD)|2.0||||0.499|TWO_SIDED|95.0|-3.1|7.1|||Cochran-Mantel-Haenszel|||||7.1|-3.1|0.499
73949231|NCT04250337|147431626|SUPERIORITY||LS Mean Difference (Final Values)|7.29|STANDARD_ERROR_OF_MEAN|5.104||0.155|TWO_SIDED|95.0|-2.78|17.36|||Mixed Models Analysis|||||17.36|-2.78|0.155
73949232|NCT04250337|147431628|SUPERIORITY||LS Mean Difference (Final Values)|-17.69|STANDARD_ERROR_OF_MEAN|4.403|<|0.001|TWO_SIDED|95.0|-26.37|-9.01|||ANCOVA|||||-9.01|-26.37|<0.001
73949233|NCT04250337|147431629|SUPERIORITY||LS Mean Difference (Final Values)|-3.33|STANDARD_ERROR_OF_MEAN|1.014||0.001031|TWO_SIDED|95.0|-5.3|-1.3|||ANCOVA|||||-1.3|-5.3|0.001031
73949234|NCT04250337|147431630|SUPERIORITY||Risk Difference (RD)|17.2||||0.036|TWO_SIDED|95.0|0.1|34.3|||Cochran-Mantel-Haenszel|||||34.3|0.1|0.036
73949235|NCT04250337|147431631|SUPERIORITY||LS Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.06|0.16|||ANCOVA|||Health State Index UK||0.16|0.06|<0.001
73949236|NCT04250337|147431631|SUPERIORITY||LS Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.018|<|0.001|TWO_SIDED|95.0|0.04|0.11|||ANCOVA|||Health State Index US||0.11|0.04|<0.001
73949237|NCT04250337|147431632|SUPERIORITY||LS Mean Difference (Final Values)|3.62|STANDARD_ERROR_OF_MEAN|2.386||0.131|TWO_SIDED|95.0|-1.08|8.32|||ANCOVA|||||8.32|-1.08|0.131
73949238|NCT04250337|147431633|SUPERIORITY||LS Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|1.145|<|0.001|TWO_SIDED|95.0|-6.26|-1.74|||Mixed Models Analysis|||||-1.74|-6.26|<0.001
73949239|NCT04250337|147431634|SUPERIORITY||LS Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.407||0.571|TWO_SIDED|95.0|-3.58|1.98|||ANCOVA|||||1.98|-3.58|0.571
73949240|NCT04250337|147431635|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.127||0.882|TWO_SIDED|95.0|-2.4|2.06|||ANCOVA|||||2.06|-2.40|0.882
73949241|NCT04250337|147431636|SUPERIORITY||LS Mean Difference (Final Values)|3.46|STANDARD_ERROR_OF_MEAN|2.48||0.171|TWO_SIDED|95.0|-1.56|8.48|||ANCOVA|||||8.48|-1.56|0.171
73949242|NCT04250337|147431637|SUPERIORITY||LS Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|2.697||0.109|TWO_SIDED|95.0|-1.03|9.89|||ANCOVA|||||9.89|-1.03|0.109
73949243|NCT04250337|147431638|SUPERIORITY||LS Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.116||0.922|TWO_SIDED|95.0|-0.22|0.24|||ANCOVA|||||0.24|-0.22|0.922
73949244|NCT04250337|147431639|SUPERIORITY||LS Mean Difference (Final Values)|-4.62|STANDARD_ERROR_OF_MEAN|1.271||0.001|TWO_SIDED|95.0|-7.22|-2.03|||Mixed Models Analysis|||||-2.03|-7.22|0.001
73949245|NCT00872430|147431645|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73949246|NCT00872430|147431646|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||All data were collected and entered before the opening of the codes of blinding of researchers. We used t test for paired samples and test for repeated measures linear regression for variables with more than two measures.With an improvement of 40% in the tea group and of 20% in the placebo group, with a power (1-ß) of 80% and a alpha error 0.05, it was necessary to include 32 points of comparison, which would be achieved with at least 16 patients, since it's a crossover study.||||<0.001
73949247|NCT02951351|147431647|NON_INFERIORITY|By non-inferiority analysis, proparacaine was inferior to povidone iodine with a 5% margin for non-inferiority. To detect non-inferiority with one positive culture in the proparacaine group, 45 patients would be required in the proparacaine group with a 5% margin.||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
73949248|NCT02951351|147431648|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
73949249|NCT02951351|147431649|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
73949250|NCT02951351|147431650|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
73949251|NCT02951351|147431651|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
73977680|NCT02434328|147501064|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-11.1|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||0.1|-11.1|
73949252|NCT02951351|147431652|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
73949253|NCT02951351|147431653|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
73949254|NCT02951351|147431654|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
73949255|NCT01580098|147431680|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.025
73949256|NCT01580098|147431681|SUPERIORITY_OR_OTHER|||||||0.182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Blood pressure: diastolic||||0.182
73949257|NCT01622543|147431706|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.046|TWO_SIDED|95.0|1.0|2.53|||Log Rank|||||2.53|1.00|0.046
73949258|NCT01622543|147431707|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
73949259|NCT01622543|147431708|SUPERIORITY||Odds Ratio (OR)|2.09||||0.06|TWO_SIDED|95.0|0.96|4.55|||Cochran-Mantel-Haenszel|||||4.55|0.96|0.06
73949260|NCT01622543|147431709|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.36|TWO_SIDED|95.0|0.78|1.98|||Log Rank|||||1.98|0.78|0.36
73949261|NCT00249496|147431712|SUPERIORITY||Odds Ratio (OR)|3.73||||0.004|TWO_SIDED|95.0|1.6|8.69|||General Estimating Equation (GEE)|||||8.69|1.60|.004
73949262|NCT00249496|147431714|SUPERIORITY||Odds Ratio (OR)|0.8|||=|0.57|TWO_SIDED|95.0|0.26|2.43|||General Estimating Equation (GEE)|||||2.43|0.26|=0.57
73949263|NCT00249496|147431716|SUPERIORITY||Odds Ratio (OR)|0.0||||0.046|TWO_SIDED|95.0|0.0|0.0|||General Estimating Equation (GEE)||The Odds Ratio and Confidence Intervals could not be calculated because one of the groups was at 0.|||0|0|0.046
73949264|NCT03292146|147431733|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||||||0.009
73949265|NCT03292146|147431734|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
73977681|NCT02434328|147501064|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-10.9|-0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-0.5|-10.9|
73949266|NCT03292146|147431735|SUPERIORITY|||||||0.06|||||||Matched pairs|||||||0.06
73949267|NCT03292146|147431735|SUPERIORITY|||||||0.01|||||||Matched pairs|||||||0.01
73949268|NCT00545363|147431738|SUPERIORITY_OR_OTHER||||||=|0.8989|||||||ANOVA|||Statistical analysis was done to compare the participant satisfaction between the Biofeedback and No-feedback arms.||||=0.8989
73949269|NCT00545363|147431739|SUPERIORITY_OR_OTHER||||||=|0.453|||||||ANOVA|||Statistical analysis was done to compare the participant perception between the Biofeedback and No-feedback arms.||||=0.453
73949270|NCT00545363|147431740|SUPERIORITY_OR_OTHER||||||=|0.4917|||||||ANOVA|||Statistical analysis was done to compare the effect of adherence (Yes/No) on percent change from baseline in CTX between the Biofeedback and No-feedback arms.||||=0.4917
73949271|NCT00366301|147431741|SUPERIORITY_OR_OTHER||Percent Change in Log CRP|20.0|STANDARD_ERROR_OF_MEAN|10.0|<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Adjusted models included terms for baseline HbA1c and weight and change in weight at each time point.||As hsCRP was measured at both 6 and 14 weeks, linear mixed models conditioning on baseline hsCRP and adjusting for treatment stratum were constructed with the dependent variable being change in lnCRP. The means at each time point were estimated from a repeated-measures model incorporating all 3 time points. The interventions were assessed by fitting terms corresponding to study drug and treatment arm assignment.||||<0.05
73949272|NCT02354963|147431747|SUPERIORITY|||||||0.302|||||||Wilcoxon (Mann-Whitney)|||||||0.302
73949273|NCT02354963|147431748|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
73949274|NCT02354963|147431749|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
73949275|NCT02354963|147431750|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|||||||0.427
73949276|NCT02354963|147431751|SUPERIORITY|||||||0.496|||||||Wilcoxon (Mann-Whitney)|||||||0.496
73949277|NCT02354963|147431752|SUPERIORITY||Risk Ratio (RR)|0.71||||0.684|TWO_SIDED|95.0|0.13|3.68|||Chi-squared|||||3.68|0.13|0.684
73949278|NCT02354963|147431753|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.480
73949279|NCT02354963|147431754|SUPERIORITY|||||||0.236|||||||Chi-squared|||||||0.236
73949280|NCT02354963|147431755|SUPERIORITY||Risk Ratio (RR)|0.71||||0.684|TWO_SIDED|95.0|0.13|3.68|||Chi-squared|||||3.68|0.13|0.684
73949281|NCT02354963|147431756|SUPERIORITY||Risk Ratio (RR)|0.36||||0.512|TWO_SIDED|95.0|0.04|3.05|||Chi-squared|||||3.05|0.04|0.512
73949282|NCT00309608|147431799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.95|-0.39||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 10 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.39|-0.95|<0.0001
73949283|NCT00309608|147431799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-1.01|-0.44||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.44|-1.01|<0.0001
73949284|NCT00309608|147431799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0055||95.0|-0.68|-0.12||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.12|-0.68|0.0055
74032468|NCT04742907|147618150|SUPERIORITY||Odds Ratio (OR)|0.9||||0.71|TWO_SIDED|95.0|0.51|1.59||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.59|0.51|0.710
73949285|NCT00309608|147431799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.99|-0.46|||Pairwise comparison based on ANCOVA|||"Placebo vs. Linagliptin 10 mg~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)."||-0.46|-0.99|<0.0001
73949286|NCT00309608|147431799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-1.02|-0.48|||Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using last observation carried forward (LOCF)."||-0.48|-1.02|<0.0001
73949287|NCT00309608|147431799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.0049||95.0|-0.66|-0.12|||Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using last observation carried forward (LOCF)."||-0.12|-0.66|0.0049
73949288|NCT00309608|147431800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|18.575||||0.0054|TWO_SIDED|95.0|2.367|145.781|||Regression, Logistic|||Linagliptin 10 mg vs. Placebo||145.781|2.367|0.0054
73949289|NCT00309608|147431800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.715||||0.0214|TWO_SIDED|95.0|1.439|95.351|||Regression, Logistic|||Linagliptin 5 mg vs. Placebo||95.351|1.439|0.0214
73949290|NCT00309608|147431800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.776||||0.0167|TWO_SIDED|95.0|1.586|102.895|||Regression, Logistic|||Linagliptin 1 mg vs. Placebo||102.895|1.586|0.0167
73949291|NCT00309608|147431800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|31.36||||0.001|TWO_SIDED|95.0|4.063|242.028|||Regression, Logistic|||Glimepiride vs. Placebo||242.028|4.063|0.0010
73949292|NCT00309608|147431801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.5|STANDARD_ERROR_OF_MEAN|6.07|<|0.0001||95.0|-41.4|-17.5|||Pairwise comparison based on ANCOVA|||Linagliptin 10mg vs. Placebo||-17.5|-41.4|<0.0001
73949293|NCT00309608|147431801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.92|STANDARD_ERROR_OF_MEAN|6.16|<|0.0001||95.0|-47.0|-22.8|||Pairwise comparison based on ANCOVA|||Linagliptin 5mg vs. Placebo||-22.8|-47.0|<0.0001
73949294|NCT00309608|147431801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.95|STANDARD_ERROR_OF_MEAN|6.13||0.0022||95.0|-31.0|-6.87|||Pairwise comparison based on ANCOVA|||Linagliptin 1 mg vs. Placebo||-6.87|-31.0|0.0022
73949295|NCT02049710|147431803|OTHER||Mean Difference (Final Values)|5.06|||||TWO_SIDED|95.0|3.0|15.0||||||Summation scores are reported across 3 items measured on a 5-point scale from 1(not at all sure)to5(very sure), which loaded together on a principal components analysis of the baseline data.The summation score thus represents a theoretical range from 3 to 15.The 3 items were as follows:Indicate How Sure You are that You Would be Able to Perform Each of the Following:a)Get the money needed to buy condoms b)Walk into a store\&buy condoms c)Find a place to get condoms for free(Cronbach alpha-0.72)||15|3|
73949296|NCT02906683|147431814|SUPERIORITY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|6.8||0.329|TWO_SIDED|95.0|-20.1|6.7|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||6.7|-20.1|0.329
73949297|NCT02906683|147431814|SUPERIORITY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|6.84||0.285|TWO_SIDED|95.0|-20.9|6.2|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||6.2|-20.9|0.285
73949298|NCT02906683|147431816|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|6.48||0.082|TWO_SIDED|95.0|-24.1|1.5|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||1.5|-24.1|0.082
73949299|NCT02906683|147431816|SUPERIORITY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.34||0.057|TWO_SIDED|95.0|-24.7|0.4|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||0.4|-24.7|0.057
73949300|NCT02906683|147431818|SUPERIORITY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|7.38||0.019|TWO_SIDED|95.0|-32.2|-3.0|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||-3.0|-32.2|0.019
73949301|NCT02906683|147431818|SUPERIORITY||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|7.36||0.023|TWO_SIDED|95.0|-31.5|-2.3|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||-2.3|-31.5|0.023
73949302|NCT02906683|147431820|SUPERIORITY||Mean Difference (Final Values)|-11.4|STANDARD_ERROR_OF_MEAN|7.36||0.125|TWO_SIDED|95.0|-25.9|3.2|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||3.2|-25.9|0.125
73949303|NCT02906683|147431820|SUPERIORITY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|7.8||0.221|TWO_SIDED|95.0|-25.1|5.9|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||5.9|-25.1|0.221
73949304|NCT00437125|147431836|SUPERIORITY_OR_OTHER||Percentage|8.6|||||ONE_SIDED|95.0||13.3||||||||13.3||
73949305|NCT00437125|147431837|SUPERIORITY_OR_OTHER|||||||0.5553||95.0||||p-value is for total UDPRS score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total UDPRS score from baseline to 12-week endpoint.||||0.5553
73949306|NCT00437125|147431838|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for psychic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total psychic subscale score from baseline to 12-week endpoint.||||<0.0001
73949307|NCT00437125|147431838|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for neurological subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total neurological subscale score from baseline to 12-week endpoint.||||<0.0001
73949308|NCT00437125|147431838|SUPERIORITY_OR_OTHER|||||||0.0014||95.0||||p-value is for autonomic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total autonomic subscale score from baseline to 12-week endpoint.||||0.0014
73870649|NCT04273893|147285249|OTHER|||||||0.05||||||Changes from baseline ALC were conducted using repeated measures models with an unstructured covariance matrix and model terms for tumor location, follow-up time. Adjustments for stratification factors were made using least squares means.|t-test, 2 sided|||||||0.05
73870650|NCT04808141|147285262|EQUIVALENCE|For a power of 80% and a two-sided 0.05 significance level, we calculated that 102 individuals would be necessary to detect a 10-point difference between the two groups. To guarantee that the study was adequately powered to detect equivalence, a posteriori analysis was conducted using the Two One-Sided Test (TOST) methodology (simulation-based power analysis).|Median Difference (Net)|-0.55||||0.412|TWO_SIDED|95.0|-2.42|5.81||the threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|robust method on the medians||||5.81|-2.42|0.412
73870651|NCT04808141|147285262|EQUIVALENCE||Odds Ratio (OR)|0.926||||0.849|TWO_SIDED|95.0|0.42|2.05||The threshold for statistical analysis was set at 0.05.|Regression, Logistic|||||2.05|0.42|0.849
73949309|NCT00437125|147431838|SUPERIORITY_OR_OTHER|||||||0.5586||95.0||||p-value is for other subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total other subscale score from baseline to 12-week endpoint.||||0.5586
73949310|NCT00437125|147431838|SUPERIORITY_OR_OTHER|||||||0.0848||95.0||||p-value is for global assessment by paticipant. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by paticipant subscale score from baseline to 12-week endpoint.||||0.0848
73949311|NCT00437125|147431838|SUPERIORITY_OR_OTHER|||||||0.0263||95.0||||p-value is for global assessment by doctor. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by doctor subscale score from baseline to 12-week endpoint.||||0.0263
73949312|NCT00437125|147431839|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 4 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 4-week endpoint.||||<0.0001
74032469|NCT04742907|147618150|SUPERIORITY||Odds Ratio (OR)|1.23||||0.41|TWO_SIDED|95.0|0.75|2.02||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Chi-squared||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||2.02|0.75|0.410
74089293|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0005|TWO_SIDED|95.0|1.35|2.92|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.92|1.35|0.0005
73870652|NCT04808141|147285263|EQUIVALENCE||Median Difference (Net)|0.3||||0.666|TWO_SIDED|95.0|-0.71|1.1||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|robust method on the medians||||1.10|-0.71|0.666
73870653|NCT04808141|147285264|EQUIVALENCE||Median Difference (Net)|-2.62||||0.122|TWO_SIDED|95.0|-14.87|4.8||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust test on the medians||||4.80|-14.87|0.122
73949313|NCT00437125|147431839|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 8 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 8-week endpoint.||||<0.0001
73949314|NCT00437125|147431839|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 12 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 12-week endpoint.||||<0.0001
73949315|NCT00437125|147431840|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for the HAMD-17 total score. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the HAMD-17 total score from baseline to 12-week endpoint.||||<0.0001
73949316|NCT00437125|147431841|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Clinical Global Impression-Severity scale - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Clinical Global Impression-Severity scale score from baseline to end of week 12 of treatment.||||<0.0001
73949317|NCT00437125|147431843|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for BDI score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no difference between baseline and post-baseline in BDI scores||||<0.0001
73949318|NCT00437125|147431844|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||p-value is for VAS overall pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS overall pain scores.||||0.0027
74032470|NCT04742907|147618150|SUPERIORITY||Odds Ratio (OR)|1.7||||0.037|TWO_SIDED|95.0|1.03|2.81||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||2.81|1.03|0.037
74032471|NCT04742907|147618150|SUPERIORITY||Odds Ratio (OR)|0.84||||0.579|TWO_SIDED|95.0|0.46|1.55||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||1.55|0.46|0.579
73870654|NCT04808141|147285265|EQUIVALENCE||Median Difference (Net)|3.32||||0.788|TWO_SIDED|95.0|-3.11|5.9||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||5.90|-3.11|0.788
73870655|NCT04808141|147285266|EQUIVALENCE||Odds Ratio (OR)|0.92||||0.081|TWO_SIDED|95.0|0.0|1.23||The threshold for statistical significance was set at 0.05.|Regression, Logistic|LR to assess the odds between groups for consuming analgesics at 8 weeks using the CG as a reference.||||1.23|0.00|0.081
73870656|NCT04808141|147285266|EQUIVALENCE||Odds Ratio (OR)|0.26||||0.985|TWO_SIDED|95.0|0.0|1.71||The threshold for statistical significance was set at 0.05.|Regression, Logistic|LR to assess the odds between groups for consuming opioids at 8 weeks using the CG as a reference.||||1.71|0.00|0.985
73870657|NCT04808141|147285267|EQUIVALENCE||Median Difference (Net)|-0.42||||0.871|TWO_SIDED|95.0|-2.1|1.78||the threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||1.78|-2.10|0.871
73949319|NCT00437125|147431844|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||p-value is for VAS Headaches score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS headaches scores.||||0.0002
73949320|NCT00437125|147431844|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS back ache score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS back ache scores.||||<0.0001
73949321|NCT00437125|147431844|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS shoulder pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS shoulder pain score.||||<0.0001
73949322|NCT00437125|147431844|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS interference score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS interference score.||||<0.0001
73949323|NCT00437125|147431844|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS pain while awake score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS pain while awake score.||||<0.0001
73949324|NCT00437125|147431845|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for PDQ-39 total score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in PDQ-39 total score.||||<0.0001
73949325|NCT02248961|147431852|OTHER|It was calculated that at least 140 patients (70 patients per group) must be enrolled into the study to achieve 80% power. With regard to 20% of patients withdrawn prematurely or data not suitable for analysis, it was necessary to include at least 176 patients (88 per group) into the study.|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|1.0|=|0.39|ONE_SIDED|95.0||1.47|||Mixed Models Analysis|||"The null hypothesis (H0) is that there is a decrease in SBP on the background treatment with Kanarb (fimasartan), that is at least 5.5 mmHg lower compared to Cozaar® (losartan).~Test of the hypotheses was performed using mixed linear models, where the site effect was considered a random effect, and the treatment group effect was considered a fixed effect. Baseline SBP on the study arm was included into the model as a covariate (a fixed effect) in all cases."||1.47||=0.390
73949326|NCT02248961|147431853|OTHER||||||=|0.018|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.018
73977682|NCT02434328|147501064|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.9|0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||0.6|-10.9|
73977683|NCT02434328|147501064|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-11.0|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||-0.1|-11.0|
74032472|NCT04742907|147618150|SUPERIORITY||Odds Ratio (OR)|0.63||||0.167|TWO_SIDED|95.0|0.33|1.21||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic|||For Day 3||1.21|0.33|0.167
73949327|NCT02248961|147431854|OTHER||||||=|0.579|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.579
73949328|NCT02248961|147431855|OTHER||||||=|0.466|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.466
73949329|NCT02248961|147431856|OTHER||||||=|0.118|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.118
73949330|NCT02248961|147431857|OTHER||||||=|0.662|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.662
73949331|NCT02248961|147431858|OTHER||||||=|0.143|||||||Mantel Haenszel|||||||=0.143
74032473|NCT04742907|147618150|SUPERIORITY||Odds Ratio (OR)|0.63||||0.4|TWO_SIDED|95.0|0.21|1.86||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||1.86|0.21|0.400
73949332|NCT00871351|147431895|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.6|||<|0.0001|TWO_SIDED|95.0|-15.4|-5.8|||Hochberg's method|||||-5.8|-15.4|<0.0001
73949333|NCT00871351|147431895|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-26.5|||<|0.0001|TWO_SIDED|95.0|-31.8|-21.2|||Hochberg's method|||||-21.2|-31.8|<0.0001
73949334|NCT00871351|147431896|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Hochberg's method|||||||0.0003
73949335|NCT00871351|147431896|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Hochberg's method|||||||<0.0001
73949336|NCT02791490|147431904|SUPERIORITY||Difference in Least Squares Means|-0.41|||<|0.001|TWO_SIDED|95.0|-0.59|-0.23|||Longitudinal Data Analysis|||||-0.23|-0.59|<0.001
73949337|NCT02791490|147431905|OTHER|95% CI|Difference in % vs Placebo|-1.7|||||TWO_SIDED|95.0|-10.8|7.4|||Miettinen and Nurminen method|||||7.4|-10.8|
73949338|NCT02791490|147431907|SUPERIORITY||Relative Risk|1.7||||0.002|TWO_SIDED|95.0|1.2|2.5|||Miettinen and Nurminen method|||||2.5|1.2|0.002
73949339|NCT02791490|147431908|SUPERIORITY||Difference in Least Squares Means|-12.4||||0.002|TWO_SIDED|95.0|-20.2|-4.6|||Longitudinal Data Analysis|||||-4.6|-20.2|0.002
73949340|NCT03959592|147431964|OTHER|||||||0.14|||||||Generalized Estimating Equations|||||||0.14
74032474|NCT04742907|147618150|SUPERIORITY||Odds Ratio (OR)|0.28||||0.083|TWO_SIDED|95.0|0.07|1.18|||Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||1.18|0.07|0.083
73949341|NCT03959592|147431965|OTHER|||||||0.423|||||||Generalized Estimating Equations|||||||0.423
73949342|NCT03959592|147431968|OTHER|||||||0.985|||||||Generalized Estimating Equations|||||||0.985
73949343|NCT03959592|147431969|OTHER|||||||0.545|||||||Generalized Estimating Equations|||||||0.545
73949344|NCT02340520|147431971|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73949345|NCT02340520|147431972|OTHER||||||>|0.1|||||||ANOVA|||||||>0.1
73949346|NCT01003639|147431973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.05|TWO_SIDED|95.0|0.0|1.43|||ANCOVA|||||1.43|0|0.05
73949347|NCT01586338|147431978|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance = 0.05.|Paired t-test|||||||<0.0001
73949348|NCT01586338|147431978|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Sign Rank Test|||||||<0.0001
73949349|NCT04362137|147431996|SUPERIORITY||Odds Ratio (OR)|0.91||||0.769|TWO_SIDED|95.0|0.48|1.73|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|||1.73|0.48|0.769
73949350|NCT04362137|147431998|SUPERIORITY||Odds Ratio (OR)|0.89||||0.647|TWO_SIDED|95.0|0.55|1.46|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.46|0.55|0.647
73949351|NCT04362137|147431998|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.52|1.92|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||1.92|0.52|0.997
73949352|NCT04362137|147431999|SUPERIORITY||Odds Ratio (OR)|0.98||||0.946|TWO_SIDED|95.0|0.51|1.87|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.87|0.51|0.946
73949353|NCT04362137|147431999|SUPERIORITY||Odds Ratio (OR)|0.79||||0.573|TWO_SIDED|95.0|0.35|1.79|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||1.79|0.35|0.573
73949354|NCT04362137|147432000|SUPERIORITY||Odds Ratio (OR)|0.75||||0.532|TWO_SIDED|95.0|0.31|1.83|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 15||1.83|0.31|0.532
73949355|NCT04362137|147432000|SUPERIORITY||Odds Ratio (OR)|1.18||||0.764|TWO_SIDED|95.0|0.4|3.49|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 29||3.49|0.40|0.764
73949356|NCT04362137|147432001|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.33|TWO_SIDED|95.0|0.9|1.37|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.37|0.90|0.330
73949357|NCT04362137|147432002|SUPERIORITY||Least squares (LS) mean|-0.03|STANDARD_ERROR_OF_MEAN|0.144||0.831|TWO_SIDED|95.0|-0.31|0.25|||ANCOVA|||Day 15||0.25|-0.31|0.831
73949358|NCT04362137|147432002|SUPERIORITY||LS Mean|0.08|STANDARD_ERROR_OF_MEAN|0.155||0.624|TWO_SIDED|95.0|-0.23|0.38|||ANCOVA|||Day 29||0.38|-0.23|0.624
73949359|NCT04362137|147432003|SUPERIORITY||Odds Ratio (OR)|0.94||||0.944|TWO_SIDED|95.0|0.2|5.57|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 15||5.57|0.20|0.944
73949360|NCT04362137|147432003|SUPERIORITY||Odds Ratio (OR)|1.21||||0.775|TWO_SIDED|95.0|0.35|5.11|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 29||5.11|0.35|0.775
73949361|NCT04362137|147432004|SUPERIORITY||Odds Ratio (OR)|0.99||||0.987|TWO_SIDED|95.0|0.45|2.21|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|||2.21|0.45|0.987
73949362|NCT04362137|147432005|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.738|TWO_SIDED|95.0|0.84|1.28|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.28|0.84|0.738
73949363|NCT04362137|147432006|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.869|TWO_SIDED|95.0|0.84|1.23|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.23|0.84|0.869
73949364|NCT04362137|147432009|SUPERIORITY||Odds Ratio (OR)|0.61||||0.325|TWO_SIDED|95.0|0.23|1.63|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.63|0.23|0.325
73949365|NCT04362137|147432009|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.25|5.4||P-value was not estimable because \>97% patients fall into one category (responders) in both groups, and very few patients fall into the other one (non-responders), which made the logistic regression model fail to converge even with Firth's correction|Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||5.40|0.25|
73949366|NCT01234649|147432053|SUPERIORITY||||||<|0.04|||||||ANOVA|||Factorial repeated measures design||||<0.04
73949367|NCT01234649|147432054|SUPERIORITY||||||<|0.005|||||||ANOVA|||Factorial repeated measures ANOVA||||<.005
73949368|NCT01234649|147432055|SUPERIORITY||||||<|0.011|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.011
73949369|NCT01234649|147432056|SUPERIORITY||||||>|0.05|||||||ANOVA|||Nested repeated measures design||||>0.05
73949370|NCT01234649|147432057|SUPERIORITY||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.03
73949371|NCT01234649|147432058|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
73949372|NCT01234649|147432059|SUPERIORITY||||||<|0.048|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.048
73949373|NCT01234649|147432060|SUPERIORITY||||||<|0.04|||||||ANOVA|||||||<0.04
73949374|NCT01234649|147432061|SUPERIORITY||||||<|0.047|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.047
73949375|NCT01234649|147432062|SUPERIORITY||||||<|0.023|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.023
73949376|NCT01234649|147432063|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
73949377|NCT01234649|147432064|SUPERIORITY|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA||||0.042
73949378|NCT01234649|147432065|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
73949379|NCT01234649|147432066|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
73949380|NCT01234649|147432067|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
73949381|NCT01234649|147432068|SUPERIORITY||||||<|0.046|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.046
73949382|NCT01234649|147432069|SUPERIORITY||||||<|0.049|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.049
73949383|NCT01234649|147432070|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
73949384|NCT01234649|147432071|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
73949385|NCT01234649|147432072|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
74032475|NCT04742907|147618151|SUPERIORITY||Odds Ratio (OR)|1.33||||0.621|TWO_SIDED|95.0|0.43|4.14||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||POI-related Morbidity status is analyzed using logistic regression with POI-related morbidity as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|||4.14|0.43|0.621
74032476|NCT04742907|147618151|SUPERIORITY||Odds Ratio (OR)|1.03||||0.962|TWO_SIDED|95.0|0.31|3.46||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||POI-related Morbidity status is analyzed using logistic regression with POI-related morbidity as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|||3.46|0.31|0.962
74089294|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.66||||0.01|TWO_SIDED|95.0|1.13|2.45|||Regression, Logistic|||Week 8, \>=50%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.13|0.0100
74089295|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0023|TWO_SIDED|95.0|1.28|3.12|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.12|1.28|0.0023
73949386|NCT01234649|147432073|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
73949387|NCT01234649|147432074|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
73977684|NCT02434328|147501064|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.5|-1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.2|-12.5|
73977685|NCT02434328|147501064|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-10.7|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||-0.3|-10.7|
73977686|NCT02434328|147501064|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-12.4|-0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-0.9|-12.4|
73977687|NCT02434328|147501064|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.0|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.4|-7.0|
73977688|NCT02434328|147501064|OTHER||Difference in proportions|-4.8|||||TWO_SIDED|95.0|-10.5|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||1.3|-10.5|
73977689|NCT02434328|147501064|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-11.4|0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||0.5|-11.4|
73977690|NCT02434328|147501064|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.5|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-0.3|-11.5|
73977691|NCT02434328|147501065|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-14.2|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.2|-14.2|
73977692|NCT02434328|147501065|OTHER||Difference in proportions|-9.2|||||TWO_SIDED|95.0|-15.5|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.5|-15.5|
73977693|NCT02434328|147501065|OTHER||Difference in proportions|-8.7|||||TWO_SIDED|95.0|-15.0|-2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.6|-15.0|
73977694|NCT02434328|147501065|OTHER||Difference in proportions|-15.7|||||TWO_SIDED|95.0|-22.9|-9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-9.0|-22.9|
73977695|NCT02434328|147501065|OTHER||Difference in proportions|7.7|||||TWO_SIDED|95.0|0.9|14.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||14.8|0.9|
73977696|NCT02434328|147501065|OTHER||Difference in proportions|-20.0|||||TWO_SIDED|95.0|-27.3|-13.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-13.1|-27.3|
73949388|NCT00318149|147432079|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS25 Group) was smaller than (\<) 2.0.|Geometric mean ratio|0.9|||||TWO_SIDED|98.75|0.7|1.16||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS25 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.16|0.7|
73949389|NCT00318149|147432079|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS50 Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.05|||||TWO_SIDED|98.75|0.71|1.56||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS50 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.56|0.71|
73949390|NCT00318149|147432079|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01B Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.04|||||TWO_SIDED|98.75|0.79|1.38||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01B administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.38|0.79|
73949391|NCT00318149|147432079|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01E Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.07|||||TWO_SIDED|98.75|0.79|1.44||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01E administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.44|0.79|
73949392|NCT01304082|147432092|SUPERIORITY_OR_OTHER|||||||0.7535||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||0.7535
73949393|NCT01304082|147432093|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
73949394|NCT01304082|147432094|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
73949395|NCT01304082|147432095|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
73949396|NCT02306122|147432100|SUPERIORITY||Risk Difference (RD)|-0.015|STANDARD_ERROR_OF_MEAN|0.034|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
73949397|NCT02306122|147432100|SUPERIORITY||Risk Difference (RD)|-0.015|STANDARD_ERROR_OF_MEAN|0.041|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
73949398|NCT02306122|147432100|SUPERIORITY||Risk Difference (RD)|0.012|STANDARD_ERROR_OF_MEAN|0.029|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
73949399|NCT02306122|147432101|SUPERIORITY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|2.523|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
73949400|NCT02306122|147432101|SUPERIORITY||Mean Difference (Final Values)|-1.582|STANDARD_ERROR_OF_MEAN|2.997|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
73949401|NCT02306122|147432101|SUPERIORITY||Mean Difference (Final Values)|0.308|STANDARD_ERROR_OF_MEAN|2.38|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
73949402|NCT02306122|147432102|SUPERIORITY||Risk Difference (RD)|-0.043|STANDARD_ERROR_OF_MEAN|0.068|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the information arm|||||<0.01
73949403|NCT02306122|147432102|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.063|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the information arm|||||<0.01
73949404|NCT02306122|147432103|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.071|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the choice arm|||||<0.01
73949405|NCT02262260|147432108|NON_INFERIORITY|"In order to demonstrate that the wait and extend regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in BCVA at month 12 from the baseline visit were determined for both treatment groups, and a comparison was made between the two groups using the Independent Samples t-test."||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
73949406|NCT02262260|147432109|NON_INFERIORITY|"In order to demonstrate that the wait and extend regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in Central Retinal Thickness determined with Optical Coherence Tomography for both eyes were calculated for both groups and were compared using the Mann Whitney u test."||||||0.082|||||||Wilcoxon (Mann-Whitney)|||||||0.082
73949407|NCT02262260|147432112|NON_INFERIORITY|Comparison was made between the two groups using the Independent Samples t-test.||||||0.095|||||||Chi-squared|||||||0.095
73870658|NCT04808141|147285268|EQUIVALENCE||Median Difference (Final Values)|0.43||||0.36|TWO_SIDED|95.0|-0.59|1.59||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||1.59|-0.59|0.360
73870659|NCT04808141|147285269|EQUIVALENCE||Mean Difference (Final Values)|0.09||||0.837|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|t-test, 2 sided|||||||0.837
73949408|NCT02262260|147432113|NON_INFERIORITY|comparison was made between the two groups using the Independent Samples t-test.||||||0.072|||||||Chi-squared|||||||0.072
73949409|NCT02262260|147432114|NON_INFERIORITY|comparison was made between the two groups using the Independent Samples t-test||||||0.466|||||||Chi-squared|||||||0.466
74032477|NCT04742907|147618153|SUPERIORITY||Odds Ratio (OR)|1.16||||0.604|TWO_SIDED|95.0|0.66|2.05||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||2.05|0.66|0.604
73949410|NCT01794117|147432123|SUPERIORITY|||||||0.033|||||||Wilcoxon Signed Rank Test|||||||0.033
73949411|NCT02322814|147432134|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.247||95.0|0.43|1.24|||Log Rank|||||1.24|0.43|0.2470
73949412|NCT02322814|147432136|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5912||95.0|0.65|2.13|||Log Rank|||||2.13|0.65|0.5912
73949413|NCT02459093|147432157|SUPERIORITY||Risk Ratio (RR)|0.61||||0.04|TWO_SIDED|95.0|0.37|0.99|||Chi-squared|||||0.99|0.37|0.04
73949414|NCT02459093|147432158|SUPERIORITY||Risk Ratio (RR)|0.6||||0.05|TWO_SIDED|95.0|0.36|1.01|||Chi-squared|||||1.01|0.36|0.05
73949415|NCT01152294|147432217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.6|STANDARD_DEVIATION|2.4||0.01|TWO_SIDED|95.0|1.02|7.96|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.||7.96|1.02|0.01
73949416|NCT00610701|147432219|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
73949417|NCT01744860|147432220|SUPERIORITY_OR_OTHER||Kappa coefficient|0.8611|||||TWO_SIDED|95.0|0.8125|0.9097||||||"Kappa coefficient was used to compare the concordance between INCa Molecular Genetics Laboratory in-house methods and Cobas 4800 Mutation Test."||0.9097|0.8125|
73949418|NCT02736968|147432252|SUPERIORITY||Difference in Proportions|0.0|||>|0.999|TWO_SIDED|95.0|-0.12|0.12||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact||Adjusted Wald Intervals|The null hypothesis is that the probability of resolution of diarrhea by Day 5 for participants receiving auranofin is equal to that for those receiving placebo.||0.12|-0.12|>0.999
73949419|NCT02736968|147432253|SUPERIORITY||Difference in Proportions|0.0|||>|0.999|TWO_SIDED|95.0|-0.34|0.34||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact||Adjusted Wald Intervals|The null hypothesis is that the probability of parasitological response by Day 5 for participants receiving auranofin is equal to that for those receiving placebo.||0.34|-0.34|>0.999
73949420|NCT02736968|147432258|SUPERIORITY|||||||0.142||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Log Rank|||The null hypothesis is that there is no difference in time to resolution of diarrhea between treatment arms, with a two-sided alternative.||||0.142
73949421|NCT01861457|147432279|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73949422|NCT01861457|147432280|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73870660|NCT04808141|147285270|EQUIVALENCE||Z-score|-1.28||||0.886|TWO_SIDED|||||The threshold for statistical significance was 0.05.|Ordinal Regression|||||||0.886
73870661|NCT04808141|147285271|EQUIVALENCE||Median Difference (Net)|1.33||||0.095|TWO_SIDED|95.0|-2.2|2.46||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||2.46|-2.20|0.095
73870662|NCT04808141|147285273|EQUIVALENCE||Mean Difference (Final Values)|65.8||||0.662|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.662
73870663|NCT04808141|147285274|EQUIVALENCE||Median Difference (Net)|-1.97||||0.246|TWO_SIDED|95.0|-12.69|3.33|||Quantile mixed-effects model|Robust method on the medians||||3.33|-12.69|0.246
73870664|NCT04808141|147285275|EQUIVALENCE||Median Difference (Net)|-0.73||||0.408|TWO_SIDED|95.0|-6.5|2.69||the threshold for statistical significance was set at 0.05|Quantile mixed-effects model|Robust method on the medians.||||2.69|-6.50|0.408
73870665|NCT04808141|147285276|EQUIVALENCE||Median Difference (Net)|0.35||||0.65|TWO_SIDED|95.0|-6.22|9.87||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||9.87|-6.22|0.650
73870666|NCT04808141|147285277|EQUIVALENCE||Difference in proportions|18.6||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
73949423|NCT00345384|147432377|SUPERIORITY_OR_OTHER||Precentage Difference|41.0||||0.03|TWO_SIDED|95.0|||||t-test, 2 sided||The percentage in opioid use by the dexmedetomidine group in comparison to the placebo for the period of time on study drug is calculated as follows: numerator = 29, denominator = 49.|||||0.03
73949424|NCT00345384|147432377|SUPERIORITY_OR_OTHER||Percentage difference|35.0||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided||A measure of opioid use, weighted for total time on study drug. This is examined by a comparison of the dexmedetomidine group to the placebo group: numerator = 35, denominator = 54.|||||0.04
73949425|NCT00345384|147432378|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||The p-value reported in this table corresponds with the 6 to 16 hour time frame.||||0.02
73949426|NCT01421589|147432379|SUPERIORITY_OR_OTHER|||||||0.02|||||||Regression, Linear|||Univariate regression analyses was performed to assess the relationship between change in skeletal muscle IGF-1 mRNA expression after 12 weeks treatment with rhGH and change in ViPCr.||||0.02
73949427|NCT01421589|147432380|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73949428|NCT01421589|147432381|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73949429|NCT01421589|147432382|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73949430|NCT01421589|147432383|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73949431|NCT01421589|147432384|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73949432|NCT01421589|147432385|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73977697|NCT02434328|147501065|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-10.4|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.4|-10.4|
73977698|NCT02434328|147501065|OTHER||Difference in proportions|-9.7|||||TWO_SIDED|95.0|-16.7|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-2.5|-16.7|
73977699|NCT02434328|147501065|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-15.8|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-3.4|-15.8|
73977700|NCT02434328|147501065|OTHER||Difference in proportions|-16.5|||||TWO_SIDED|95.0|-23.4|-9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-9.6|-23.4|
73977701|NCT02434328|147501065|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-3.3|10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||10.4|-3.3|
73977702|NCT02434328|147501065|OTHER||Difference in proportions|-18.1|||||TWO_SIDED|95.0|-24.9|-11.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-11.8|-24.9|
73977703|NCT02434328|147501065|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.2|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.2|-9.2|
73977704|NCT02434328|147501065|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-16.3|-2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-2.8|-16.3|
73977705|NCT02434328|147501065|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-12.5|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||1.1|-12.5|
73977706|NCT02434328|147501065|OTHER||Difference in proportions|-15.5|||||TWO_SIDED|95.0|-21.9|-8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-8.5|-21.9|
73977707|NCT02434328|147501065|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.9|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||7.5|-5.9|
73977708|NCT02434328|147501065|OTHER||Difference in proportions|-14.9|||||TWO_SIDED|95.0|-21.4|-8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-8.1|-21.4|
73977709|NCT02434328|147501065|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-7.5|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.4|-7.5|
73977710|NCT02434328|147501065|OTHER||Difference in proportions|-10.4|||||TWO_SIDED|95.0|-17.2|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-3.4|-17.2|
73977711|NCT02434328|147501065|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-11.4|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||2.3|-11.4|
73977712|NCT02434328|147501065|OTHER||Difference in proportions|-11.0|||||TWO_SIDED|95.0|-18.2|-4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-4.1|-18.2|
73977713|NCT02434328|147501065|OTHER||Difference in proportions|-2.9|||||TWO_SIDED|95.0|-9.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.5|-9.4|
73977714|NCT02434328|147501065|OTHER||Difference in proportions|-14.1|||||TWO_SIDED|95.0|-21.3|-7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-7.2|-21.3|
73977715|NCT02310581|147501073|OTHER||LS Mean Difference|104.973|STANDARD_ERROR_OF_MEAN|39.2433||0.012|TWO_SIDED|95.0|25.13|184.81|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||184.81|25.13|0.012
73949433|NCT02694640|147432406|SUPERIORITY|The study was powered to detect significant between-group differences in mean min/week MVPA at follow-up.|effect size|0.11|||<|0.05|TWO_SIDED|||||No adjustment for multiple comparisons was made|Regression, Linear||Effect size refers to between-group difference at follow-up.|A series of longitudinal mixed effects models with subject-specific intercepts were used to examine between-group differences in mean min/week of self reported moderate-to-vigorous physical activity (MVPA).||||<.05
73949434|NCT02694640|147432407|SUPERIORITY||effect size|0.09|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<.05
73949435|NCT00759772|147432412|SUPERIORITY||||||<|0.01||||||Calculated p-value.|t-test, 2 sided|||||||< 0.01
73949436|NCT00737061|147432469|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.9||||||95.0|97.9|100.0||||||1-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).||100|97.9|
73949437|NCT00737061|147432469|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.9||||||95.0|97.6|99.5||||||2-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).||99.5|97.6|
73949438|NCT00737061|147432479|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.4||||||95.0|97.2|100.0||||No statistical hypothesis testing was performed.||"1-sided Confidence Interval.~No hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."||100|97.2|
73949439|NCT00737061|147432479|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.4||||||95.0|96.9|99.1||||No statistical hypothesis testing was performed.||"2-sided Confidence Interval~No hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."||99.1|96.9|
73949440|NCT01844115|147432497|SUPERIORITY||Least Squares Mean Difference|-2.2||||0.0048|TWO_SIDED|95.0|-3.72|-0.68|||MMRM|||||-0.68|-3.72|0.0048
73949441|NCT01844115|147432498|SUPERIORITY||Least Squares Mean Difference|-1.89||||0.0236|TWO_SIDED|95.0|-3.52|-0.26|||MMRM|||||-0.26|-3.52|0.0236
73949442|NCT01613027|147432511|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Difference in change at Month 6||||<0.001
73949443|NCT01613027|147432511|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Difference in change at Month 12||||<0.001
73949444|NCT01108510|147432552|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: ATV+COBI+FTC/TDF group was at least 12% worse than the ATV+RTV+FTC/TDF group; alternative hypothesis: ATV+COBI+FTC/TDF group was less than 12% worse than the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95.2% confidence interval (CI) (COBI group - RTV group) was \> -12%.|Difference in percentages|-2.2|||||TWO_SIDED|95.2|-7.4|3.0|||||Difference in percentages of success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|700 planned subjects had 95% power to evaluate noninferiority assuming a response rate of 79.5% for both arms and a noninferiority margin of 12%.||3.0|-7.4|
73949445|NCT01108510|147432553|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-1.4|||||TWO_SIDED|95.0|-7.6|4.7|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||4.7|-7.6|
73949446|NCT01108510|147432554|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-2.1|||||TWO_SIDED|95.0|-8.7|4.5|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||4.5|-8.7|
73949447|NCT01108510|147432555|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.0|||||TWO_SIDED|95.0|-22.2|6.3|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||6.3|-22.2|
73977716|NCT02310581|147501073|OTHER||LS Mean Difference|86.316|STANDARD_ERROR_OF_MEAN|37.5385||0.028|TWO_SIDED|95.0|9.94|162.69|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||162.69|9.94|0.028
73977717|NCT02310581|147501073|OTHER||LS Mean Difference|64.485|STANDARD_ERROR_OF_MEAN|39.2459||0.11|TWO_SIDED|95.0|-15.36|144.33|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||144.33|-15.36|0.110
73949448|NCT01108510|147432556|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|-5.0||||0.67|TWO_SIDED|95.0|-28.0|18.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||18|-28|0.67
73949449|NCT01108510|147432557|SUPERIORITY_OR_OTHER||Difference in LSM|-10.0||||0.51|TWO_SIDED|95.0|-38.0|19.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||19|-38|0.51
73949450|NCT01108510|147432558|SUPERIORITY_OR_OTHER||Difference in LSM|-22.0||||0.18|TWO_SIDED|95.0|-54.0|10.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||10|-54|0.18
73977718|NCT02310581|147501076|OTHER||LS Mean Difference|14.398|STANDARD_ERROR_OF_MEAN|4.739||0.005|TWO_SIDED|95.0|4.76|24.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||24.04|4.76|0.005
73949451|NCT01108510|147432559|SUPERIORITY_OR_OTHER||Difference in LSM|6.0||||0.84|TWO_SIDED|95.0|-55.0|67.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||67|-55|0.84
73949452|NCT01461993|147432679|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82||||||95.0|0.72|0.94||||||HPV-6||0.94|0.72|
73949453|NCT01461993|147432679|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.91||||||HPV-11||0.91|0.74|
73949454|NCT01461993|147432679|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.88||||||HPV-16||0.88|0.68|
73949455|NCT01461993|147432679|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81||||||HPV-18||0.81|0.62|
73949456|NCT01461993|147432680|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.85|1.0||||||PMB80 \[A22\]||1.00|0.85|
73949457|NCT01461993|147432680|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.84|1.01||||||PMB2948 \[B24\]||1.01|0.84|
73949458|NCT00680056|147432691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|56.0|STANDARD_DEVIATION|60.0||0.038||95.0|||||t-test, 2 sided||Mean difference= Formoterol plus Tiotropium minus Formoterol plus Placebo(Tiotropium)|It was calculated a total sample size of a 2x2 cross-over design as 24 for a two-sided t-test achieves 85% power to infer that the mean difference is not zero, the actual mean difference is 20, the standard deviation of the differences is 15, and the significance level is 0.05||||0.038
73949459|NCT00680056|147432692|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88|STANDARD_DEVIATION|2.39||0.054||95.0|||||t-test, 2 sided||Mean difference=Arm 2 minus Arm 1|||||0.054
73949460|NCT00180713|147432814|SUPERIORITY|||||||0.028|||||||ANOVA|||||||0.028
73949461|NCT00180713|147432815|SUPERIORITY|||||||0.86|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.||||0.86
73949462|NCT00180713|147432816|SUPERIORITY|||||||0.4|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.||||0.4
73949463|NCT00180713|147432817|SUPERIORITY|||||||0.041|||||||ANOVA|||||||0.041
73977719|NCT02310581|147501076|OTHER||LS Mean Difference|8.056|STANDARD_ERROR_OF_MEAN|4.5331||0.085|TWO_SIDED|95.0|-1.17|17.28|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||17.28|-1.17|0.085
73949464|NCT00180713|147432818|SUPERIORITY|||||||0.26|||||||ANOVA|||||||0.26
73949465|NCT01567865|147432822|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|1.84|||||TWO_SIDED|95.0|-5.97|9.66||||||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||9.66|-5.97|
73949466|NCT01567865|147432822|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-2.48|||<|0.05|TWO_SIDED|95.0|-9.92|4.98|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||4.98|-9.92|<0.05
73977720|NCT02310581|147501076|OTHER||LS Mean Difference|10.063|STANDARD_ERROR_OF_MEAN|4.7393||0.041|TWO_SIDED|95.0|0.42|19.7|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||19.70|0.42|0.041
73977721|NCT02310581|147501077|OTHER||LS Mean Difference|26.665|STANDARD_ERROR_OF_MEAN|8.1991||3|TWO_SIDED|95.0|9.98|43.35|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||43.35|9.98|0003
73977722|NCT02310581|147501077|OTHER||LS Mean Difference|21.605|STANDARD_ERROR_OF_MEAN|7.8429||0.009|TWO_SIDED|95.0|5.65|37.56|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||37.56|5.65|0.009
73977723|NCT02310581|147501077|OTHER||LS Mean Difference|22.143|STANDARD_ERROR_OF_MEAN|8.1997||0.011|TWO_SIDED|95.0|5.46|38.83|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||38.83|5.46|0.011
73870667|NCT00394706|147285334|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2||||0.59|TWO_SIDED|95.0|-1.1|0.7||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|Mixed Models Analysis||Estimate of the rate of MRS \<= 3 in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of MRS \<=3 in Analyze Early vs. Analyze Later arms using a linear mixed effect model with an identity link and random effects to account for the cluster randomization.||0.7|-1.1|0.59
73870668|NCT00394706|147285334|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1||||0.71|TWO_SIDED|95.0|-1.1|0.8||To adjust for group sequential monitoring, the point estimate was bias-adjusted (Whitehead 1986) and confidence intervals and P values calculated from the maximum likelihood based ordering of the outcome(Emerson and Fleming, 1990)|t-test, 2 sided||Estimate of the rate of MRS \<= 3 in the active ITD arm minus the rate in the Sham ITD arm.|Comparison of the rates of MRS \<=3 in Active ITD and Sham treatment arms, adjusted for sequential monitoring.||0.8|-1.1|0.71
73870669|NCT00394706|147285335|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1||||0.92|TWO_SIDED|95.0|-1.2|1.1||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|GEE||Estimate of the rate of survival to hospital discharge in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of survival to hospital discharge in Analyze Early vs. Analyze Later arms using a generalized estimating equations model with an identity link, grouping on cluster.||1.1|-1.2|0.92
73870670|NCT00394706|147285335|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.99|TWO_SIDED|95.0|-1.2|1.1|||t-test, 2 sided||Estimate of the rate of survival to hospital discharge in the active ITD arm minus rate in the Sham ITD arm.|Comparison of the rates of survival to hospital discharge in Active ITD and Sham treatment arms.||1.1|-1.2|0.99
73870671|NCT00394706|147285336|SUPERIORITY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.2|0.34|||||Mean MRS for Analyze Later minus mean MRS for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.34|-0.20|
73949467|NCT01567865|147432822|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-4.33|||<|0.05|TWO_SIDED|95.0|-11.94|3.31|||t-test, 2 sided|||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||3.31|-11.94|<0.05
73949468|NCT01567865|147432822|NON_INFERIORITY|The new GMP facility lots will be considered non-inferior (i.e., equivalent) to the existing facility lot if the null hypothesis is rejected and the alternate hypothesis is accepted.|Mean Difference (Net)|-4.03|||<|0.05|TWO_SIDED|95.0|-9.74|3.1|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypothesis: reference lot vs. Lot 1, 2, and 3 combined do differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. The power of the study to test non-inferiority of the combined new lots compared to the reference lot dropped from 99% to 87%."||3.1|-9.74|<0.05
73949469|NCT04921969|147432858|SUPERIORITY||Odds Ratio (OR)|4.74||||0.0001|TWO_SIDED|95.0|1.951|13.315||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.315|1.951|0.0001
73977724|NCT02310581|147501078|OTHER||LS Mean Difference|63.881|STANDARD_ERROR_OF_MEAN|18.3971||0.001|TWO_SIDED|95.0|26.45|101.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||101.31|26.45|0.001
73870672|NCT00394706|147285336|SUPERIORITY||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.17|0.44|||||Mean MRS for Active ITD minus mean MRS for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.44|-0.17|
73870673|NCT00394706|147285337|SUPERIORITY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.71|0.83|||||Mean ALFI-MMSE for Analyze Later minus mean ALFI-MMSE for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.83|-0.71|
73870674|NCT00394706|147285337|SUPERIORITY||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-1.61|0.28|||||Mean ALFI-MMSE for Active ITD minus mean ALFI-MMSE for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.28|-1.61|
73870675|NCT00394706|147285338|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.05|||||Mean HUI for Analyze Later minus mean HUI for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.05|-0.06|
73870676|NCT00394706|147285338|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.08|0.05|||||Mean HUI for Active ITD minus mean HUI for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.05|-0.08|
73870677|NCT03369249|147285343|SUPERIORITY||log ratio of rate ratios|0.15|STANDARD_ERROR_OF_MEAN|0.31||0.635|TWO_SIDED|95.0|-0.46|0.75||A priori threshold for statistical significance was \<0.05|generalized estimating equations||Standard error of the Beta regression coefficient.|||0.75|-0.46|0.635
73870678|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.86||||||No adjustment for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Arm A vs Arm B shift test on Angiopoietin -- 2 prior to cycle 2. Wilcoxon rank-sum test p-value.||||0.86
73870679|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.76||||||Angiopoietin -- 2 prior to cycle 3.|Wilcoxon (Mann-Whitney)|||Angiopoietin -- 2 prior to cycle 3||||0.76
73870680|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.14||||||No adjustment for multiple comparison. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Tie--2 Prior to cycle 2||||0.14
73870681|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.069||||||No adjustment for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Tie -- 2 prior to cycle 3||||0.069
73870682|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.19||||||P-value is not adjusted for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||VEGF -- A prior to cycle 2||||0.19
73870683|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.046||||||P-value is not adjusted for multiple comparisons. The a-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||VEGF--A prior to cycle 3||||0.046
73977725|NCT02310581|147501078|OTHER||LS Mean Difference|50.284|STANDARD_ERROR_OF_MEAN|17.5979||0.007|TWO_SIDED|95.0|14.48|86.09|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||86.09|14.48|0.007
73870684|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.029||||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||PIGF Prior to Cycle 2||||0.029
73870685|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.2||||||P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||PIGF prior to cycle 3||||0.20
73870686|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.11||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||VEGFR--3 prior to cycle 2||||0.11
73870687|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.068||||||P-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||VEGFR--3 prior to cycle 3||||0.068
73870688|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.61||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||VEGF--C prior to cycle 2||||0.61
73949470|NCT04921969|147432858|SUPERIORITY||Odds Ratio (OR)|10.72|||<|0.0001|TWO_SIDED|95.0|4.429|30.042||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||30.042|4.429|<0.0001
73949471|NCT04921969|147432859|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4198|TWO_SIDED|95.0|0.61|3.268||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.268|0.610|0.4198
73949472|NCT04921969|147432859|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1685|TWO_SIDED|95.0|0.779|4.174||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||4.174|0.779|0.1685
73949473|NCT01288781|147432903|SUPERIORITY_OR_OTHER|||||||0.98||||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
73949474|NCT01288781|147432904|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.63
73949475|NCT01288781|147432905|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.20
73949476|NCT01288781|147432906|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||<0.01
73977726|NCT02310581|147501078|OTHER||LS Mean Difference|56.879|STANDARD_ERROR_OF_MEAN|18.3984||0.004|TWO_SIDED|95.0|19.45|94.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||94.31|19.45|0.004
73977727|NCT04658784|147501080|SUPERIORITY||Odds Ratio (OR)|0.51||||0.32|TWO_SIDED|95.0|0.13|1.92||OR, 95% CI, and p-values for outcomes adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery). P-value for VAS at 6-weeks was not adjusted for multiple comparisons.|Regression, Logistic|||OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.||1.92|0.13|0.32
73977728|NCT04658784|147501081|SUPERIORITY||Odds Ratio (OR)|0.48||||1|TWO_SIDED|95.0|0.04|5.65||OR, 95% CI, and p-values for outcomes adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery). P-value for VAS at 6-weeks was not adjusted for multiple comparisons.|Regression, Logistic|||OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.||5.65|0.04|1.0
73977729|NCT04658784|147501084|SUPERIORITY||Mean Difference (Net)|2.6||||1|TWO_SIDED|95.0|-3.5|8.7||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6- weeks.||8.7|-3.5|1.0
73977730|NCT04658784|147501084|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-5.6|3.2||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6-months.||3.2|-5.6|
73977731|NCT04658784|147501085|SUPERIORITY||Mean Difference (Net)|0.2||||1|TWO_SIDED|95.0|-6.6|6.9||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change in baseline to 6-weeks.||6.9|-6.6|1.0
73949477|NCT01288781|147432906|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Step down Holm Bonferroni correction was applied|t-test, 2 sided|||Post hoc follow up test. T test between acetazolamide and placebo on data at 24 hr time point.||||<0.01
73949478|NCT01288781|147432907|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
73949479|NCT01288781|147432908|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
73949480|NCT01288781|147432909|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
73949481|NCT03518658|147432910|SUPERIORITY||Mean Difference (Final Values)|34.7|||<|0.001|TWO_SIDED|95.0|32.4|37.0||The threshold for statistical significance was 0.025.|Generalized estimating equation model|||||37.0|32.4|<0.001
73949482|NCT03518658|147432910|SUPERIORITY||Mean Difference (Final Values)|38.3|||<|0.001|TWO_SIDED|95.0|34.8|41.9||The threshold for statistical significance was 0.025.|Generalized estimating equation model|||||41.9|34.8|<0.001
73949483|NCT01017120|147432950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA|||||||<0.001
73949484|NCT01017120|147432950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA|||||||<0.001
73949485|NCT01017120|147432950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA|||||||<0.001
73949486|NCT01017120|147432951|SUPERIORITY_OR_OTHER||Percentage of participants|32.2|||<|0.001|TWO_SIDED|95.0|27.4|36.9|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||36.9|27.4|<0.001
73977732|NCT04658784|147501085|SUPERIORITY|Differences in mean change and 95% CI generated from general linear models. Change in baseline to 6-months.|Mean Difference (Net)|2.8||||1|TWO_SIDED|95.0|-3.1|8.6||Adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||||8.6|-3.1|1
73977733|NCT04658784|147501086|SUPERIORITY||Mean Difference (Net)|-1.6||||1|TWO_SIDED|95.0|-4.4|1.3||Adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6 months.||1.3|-4.4|1.0
73977734|NCT03418545|147501230|SUPERIORITY||Percentage difference|67.5|||<|0.0001|TWO_SIDED|95.0|52.9|82.0||The p-value and 95% CI are computed by pooling 5 imputed datasets using PROC MIANALYZE in SAS with normal approximation. The p-value and 95% CI for each imputed data set is based on the Fisher's exact test and the Wald test, respectively.|Fisher Exact|||||82.0|52.9|<0.0001
73977735|NCT03418545|147501231|SUPERIORITY||Percentage difference|73.5|||||TWO_SIDED|95.0|60.2|86.8|||||The 95% CI is based on the Wald test.|||86.8|60.2|
73870689|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.27||||||Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.|Wilcoxon (Mann-Whitney)|||VEGF--C prior to cycle 3||||0.27
73870690|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.61||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||IL--8 prior to cycle 2||||0.61
73870691|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.49||||||The p-value was not adjusted for multiple comparisons, and the a-priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||IL--8 prior to cycle 3||||0.49
73870692|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.82||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||ICAM--1 prior to cycle 2||||0.82
73870693|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.069||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||ICAM--1 prior to cycle 3||||0.069
73870694|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.34||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||VCAM--1 prior to cycle 2||||0.34
73977736|NCT03418545|147501233|SUPERIORITY||||||<|0.0001||||||A 2-sided paired t-test at the 5% level was performed to demonstrate that the mean overall satisfaction score at Month 3 was statistically greater than that at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
73977737|NCT01989793|147501251|EQUIVALENCE|Equivalence margin=0||||||0.97|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 8||||0.97
73977738|NCT01989793|147501252|EQUIVALENCE|Equivalence margin=0||||||0.48|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 16||||0.48
73977739|NCT01989793|147501253|EQUIVALENCE|Equivalence margin = 0||||||0.59|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 24||||0.59
73870695|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.046||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||VCAM--1 prior to cycle 3||||0.046
73870696|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.11||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||FGF2 prior to cycle 2||||0.11
73870697|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.23||||||The p-value was adjusted for multiple comparisons. The a prior threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||FGF2 prior to cycle 3||||0.23
73870698|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.37||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||PDGF--AA prior to cycle 2||||0.37
73870699|NCT01664182|147285406|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.35||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||PDGF--AA prior to cycle 3||||0.35
73870700|NCT05292131|147285407|EQUIVALENCE|Bioequivalence (BE) was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for AUC.|Geometric Mean Ratio (percentage [%])|97.5|||||TWO_SIDED|90.0|90.2|105.4||||||||105.40|90.20|
73870701|NCT05292131|147285408|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for AUC0-t.|Geometric Mean Ratio (%)|97.05|||||TWO_SIDED|90.0|90.1|104.55||||||||104.55|90.10|
73870702|NCT05292131|147285409|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for Cmax.|Geometric Mean Ratio (%)|96.21|||||TWO_SIDED|90.0|88.6|104.47||||||||104.47|88.60|
73977740|NCT01989793|147501254|EQUIVALENCE|Equivalence margin=0||||||0.212|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 8||||0.212
73977741|NCT01989793|147501255|EQUIVALENCE|Equivalence margin=0||||||0.271|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 16||||0.271
73977742|NCT01989793|147501256|EQUIVALENCE|Equivalence margin=0||||||0.203|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 24||||0.203
73977743|NCT01989793|147501257|EQUIVALENCE|Equivalence margin = 0||||||0.82|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.82
73977744|NCT01989793|147501258|EQUIVALENCE|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.73
73977745|NCT01989793|147501259|EQUIVALENCE|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.73
73870703|NCT05292131|147285412|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for t½.|Geometric Mean Ratio (%)|101.13|||||TWO_SIDED|90.0|94.18|108.59||||||||108.59|94.18|
73870704|NCT05292131|147285413|EQUIVALENCE|The point estimate and the 90% CI for the median treatment differences for tmax was computed according to the Hodges-Lehmann's method.|Hodges-Lehman Estimate|0.4897|||||TWO_SIDED|90.0|-0.0073|0.9567||||||||0.9567|-0.0073|
73870705|NCT02881762|147285429|OTHER|Comparison of mean change analyzed with unpaired t-test for parametric data. The test was performed with a significance level of 0.05 (two-sided).||||||0.13|||||||t-test, 2 sided|||Null hypothesis is that there is no difference in change in HCV viral load between Maraviroc and No Maraviroc||||0.13
73870706|NCT02881762|147285430|OTHER|Comparison of difference in mean analyzed with paired t-test for parametric data. The test was performed with a significance level of 0.05 (two-sided).|||||>|0.5|||||||t-test, 2 sided|||Null hypothesis is that there is no difference in HCV viral load between baseline and 7 days of maraviroc.||||>0.5
73870707|NCT01053988|147285439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.053||||0.04|TWO_SIDED|95.0|0.003|0.104||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.104|0.003|0.040
73977746|NCT02233998|147501281|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.234|STANDARD_ERROR_OF_MEAN|0.0162|<|0.001|TWO_SIDED|95.0|-0.266|-0.202||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.202|-0.266|<0.001
73977747|NCT02233998|147501281|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.197|STANDARD_ERROR_OF_MEAN|0.0161|<|0.001|TWO_SIDED|95.0|-0.228|-0.165||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.165|-0.228|<0.001
73977748|NCT02233998|147501282|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.469|STANDARD_ERROR_OF_MEAN|0.0286|<|0.001|TWO_SIDED|95.0|-0.526|-0.413||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.413|-0.526|<0.001
73977749|NCT02233998|147501282|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.379|STANDARD_ERROR_OF_MEAN|0.0286|<|0.001|TWO_SIDED|95.0|-0.435|-0.322||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.322|-0.435|<0.001
73977750|NCT02233998|147501283|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.006|<|0.001|TWO_SIDED|95.0|-0.042|-0.019||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.019|-0.042|<0.001
73977751|NCT02233998|147501283|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.026|STANDARD_ERROR_OF_MEAN|0.0059|<|0.001|TWO_SIDED|95.0|-0.038|-0.014||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.014|-0.038|<0.001
73977752|NCT02233998|147501284|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|23.24|||<|0.001|TWO_SIDED|95.0|20.75|25.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||25.85|20.75|<0.001
73977753|NCT02233998|147501284|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.444|||<|0.001|TWO_SIDED|95.0|17.09|22.22||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||22.22|17.09|<0.001
73977754|NCT02233998|147501285|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.048|||<|0.001|TWO_SIDED|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||21.73|15.94|<0.001
73977755|NCT02233998|147501285|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|15.939|||<|0.001|TWO_SIDED|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||18.67|12.50|<0.001
73870708|NCT01053988|147285439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.103|||<|0.001|TWO_SIDED|95.0|0.052|0.153|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.153|0.052|<0.001
74089296|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0322|TWO_SIDED|95.0|1.04|2.58|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.04|0.0322
73870709|NCT01053988|147285439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.192|||<|0.001|TWO_SIDED|95.0|0.141|0.243||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.243|0.141|<0.001
73870710|NCT01053988|147285439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.173|||<|0.001|TWO_SIDED|95.0|0.123|0.224|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.224|0.123|<0.001
73977756|NCT02233998|147501286|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|2.05|||<|0.001|TWO_SIDED|95.0|1.3|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.78|1.30|<0.001
73977757|NCT02233998|147501286|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|1.19|||<|0.001|TWO_SIDED|95.0|0.93|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.06|0.93|<0.001
73977758|NCT02233998|147501287|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|1.316||||0.016|TWO_SIDED|95.0|0.0|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.78|0.00|0.016
73977759|NCT02233998|147501287|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|0.926||||0.197|TWO_SIDED|95.0|-0.16|1.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||1.85|-0.16|0.197
73977760|NCT02233998|147501288|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|23.214|||<|0.001|TWO_SIDED|95.0|18.21|28.77||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||28.77|18.21|<0.001
73977761|NCT02233998|147501288|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|18.59|||<|0.001|TWO_SIDED|95.0|13.69|23.81||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||23.81|13.69|<0.001
73977762|NCT02233998|147501289|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.048|||<|0.001|TWO_SIDED|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||21.73|15.94|<0.001
73977763|NCT02233998|147501289|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|15.939|||<|0.001|TWO_SIDED|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||18.67|12.50|<0.001
73870711|NCT01053988|147285439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.12|||<|0.001|TWO_SIDED|95.0|0.07|0.17|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.170|0.070|<0.001
73977764|NCT01957163|147501290|SUPERIORITY_OR_OTHER||Least squared mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.093|0.154|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.154|0.093|< 0.001
73977765|NCT01957163|147501290|SUPERIORITY_OR_OTHER||Least squared mean difference|0.128|||<|0.001|TWO_SIDED|95.0|0.098|0.159|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.159|0.098|<0.001
73977766|NCT01957163|147501291|SUPERIORITY_OR_OTHER||Least squared mean difference|0.153|||<|0.001|TWO_SIDED|95.0|0.118|0.187|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.187|0.118|<0.001
74089297|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2005|TWO_SIDED|95.0|0.81|2.67|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.67|0.81|0.2005
73870712|NCT01053988|147285439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.14||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.140|0.039|<0.001
73870713|NCT01053988|147285439|SUPERIORITY_OR_OTHER||Least squares mean difference|0.071||||0.006|TWO_SIDED|95.0|0.021|0.121||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.121|0.021|0.006
73870714|NCT01053988|147285440|SUPERIORITY_OR_OTHER||Least squares mean difference|0.033||||0.241|TWO_SIDED|95.0|-0.022|0.088|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.088|-0.022|0.241
73949487|NCT01017120|147432951|SUPERIORITY_OR_OTHER||Percentage of participants|18.2|||||TWO_SIDED|95.0|14.2|22.1|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||22.1|14.2|
73977767|NCT01957163|147501291|SUPERIORITY_OR_OTHER||Least squared mean difference|0.14|||<|0.001|TWO_SIDED|95.0|0.106|0.175|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.175|0.106|<0.001
73977768|NCT01321073|147501357|SUPERIORITY||||||<|0.0001|||||||1-sample exact test for Poisson rate|||The rate of catheter-related complications per 1000 patient-days was compared to a pre-specified value of 2.5 / 1000 days. This was calculated based on published complication rates in PAH that included central venous catheter systemic bloodstream infections (0.43-1.13), site infections (0.26-0.87), and complications from catheter thrombosis, mechanical dysfunction, or catheter dislocation in the general central venous catheter population (0.36-0.51). The sum of the upper rates is 2.5.||||<0.0001
73977769|NCT03697603|147501385|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.0312|TWO_SIDED|95.0|-2.7|-0.1|||MMRM|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 6.||-0.1|-2.7|0.0312
73977770|NCT03697603|147501385|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.0089|TWO_SIDED|95.0|-3.0|-0.4|||MMRM|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 6.||-0.4|-3.0|0.0089
73977771|NCT03697603|147501386|OTHER||Diff|5.5||||0.1964|TWO_SIDED|95.0|-2.8|13.8|||Chi-squared|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 6.||13.8|-2.8|0.1964
73977772|NCT03697603|147501386|OTHER||Diff|5.5||||0.1969|TWO_SIDED|95.0|-2.8|13.7|||Chi-squared|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 6.||13.7|-2.8|0.1969
73977773|NCT02686658|147501387|OTHER|Model for repeated measures (MRM) and square root transformation was used to compare the treatment groups.|Least Squares Mean Difference|0.11||||0.0072|TWO_SIDED|95.0|||||Model for repeated measures (MRM)|||Difference in least squares means between groups calculated as (Sham) minus (Zimura).||||0.0072
73977774|NCT02686658|147501387|OTHER|Model for repeated measures (MRM) and square root transformation was used to compare treatment groups.|Least Squares Mean Difference|0.124||||0.0051|TWO_SIDED|95.0|||||Model for repeated measures (MRM)|||Difference in least squares means between groups calculated as (Sham) minus (Zimura).||||0.0051
73949488|NCT01017120|147432952|SUPERIORITY_OR_OTHER||Percentage of participants|27.6|||<|0.001|TWO_SIDED|95.0|23.1|32.2|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.|||32.2|23.1|<0.001
73949489|NCT01017120|147432952|SUPERIORITY_OR_OTHER||Percentage of participants|13.3|||||TWO_SIDED|95.0|9.8|16.7|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.|||16.7|9.8|
74089298|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1923|TWO_SIDED|95.0|0.82|2.68|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.68|0.82|0.1923
74089299|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0013|TWO_SIDED|95.0|1.28|2.79|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|1.28|0.0013
73949490|NCT01087723|147432972|SUPERIORITY_OR_OTHER||Relative risk|0.6||||0.0014|TWO_SIDED|95.0|0.43|0.82|||Chi-squared|||||0.82|0.43|0.0014
73977775|NCT02686658|147501388|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|1.39||||0.3464|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.3464
73977776|NCT02686658|147501388|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|-0.28||||0.883|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.8830
73977777|NCT02686658|147501389|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|0.38||||0.8405|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.8405
73977778|NCT02686658|147501389|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|-1.44||||0.5017|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.5017
73977779|NCT02222493|147501429|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence test|Proportion Difference|-2.39|||||TWO_SIDED|95.0|-9.92|5.11||||||Score statistic method||5.11|-9.92|
73977780|NCT02222493|147501429|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence test|Proportion Difference|-2.39|||||TWO_SIDED|90.0|-8.75|4.02||||||Score statistic method||4.02|-8.75|
73977781|NCT03924869|147501471|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2932|TWO_SIDED|95.0|0.69|1.24||1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.|Log Rank|||"Hazard ratio and 95% confidence intervals (CIs) were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery)."||1.24|0.69|0.29320
73870715|NCT01053988|147285440|SUPERIORITY_OR_OTHER||Least squares mean difference|0.067||||0.017|TWO_SIDED|95.0|0.012|0.121|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.121|0.012|0.017
73870716|NCT01053988|147285440|SUPERIORITY_OR_OTHER||Least squares mean difference|0.129|||<|0.001|TWO_SIDED|95.0|0.074|0.184||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.184|0.074|<0.001
73870717|NCT01053988|147285440|SUPERIORITY_OR_OTHER||Least squares mean difference|0.115|||<|0.001|TWO_SIDED|95.0|0.06|0.169|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.169|0.060|<0.001
73870718|NCT01053988|147285440|SUPERIORITY_OR_OTHER||Least squares mean difference|0.082||||0.003|TWO_SIDED|95.0|0.028|0.136||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.136|0.028|0.003
73870719|NCT01053988|147285440|SUPERIORITY_OR_OTHER||Least squares mean difference|0.062||||0.025|TWO_SIDED|95.0|0.008|0.117||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.117|0.008|0.025
73870720|NCT01053988|147285440|SUPERIORITY_OR_OTHER||Least squares mean difference|0.048||||0.082|TWO_SIDED|95.0|-0.006|0.102|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.102|-0.006|0.082
73870721|NCT05723263|147285661|OTHER||Proportional difference|91.0|||<|0.01|TWO_SIDED|95.0|90.2|91.8||The threshold for statistical significance was p\<0.05.|Generalized Estimating Equations|||It was calculated that 12 clinic sites with 1200 participants randomized in a 1:1:1 ratio between the three arms, would have at least 90% power to detect a 10% difference in the proportion of test uptake between the pay-it-forward and control group participants, using a two-sided, two-sample t-test (α=0.05), assuming a 0.25\~0.31 cluster coefficient of variation, \<5% lost-to-follow-up rate, and an intra-class correlation of 0.016.||91.8|90.2|<0.01
73870722|NCT05723263|147285662|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73870723|NCT05723263|147285663|OTHER|||||||0.0059|||||||Chi-squared|||||||0.0059
73870724|NCT05723263|147285664|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73870725|NCT05723263|147285666|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73870726|NCT05723263|147285667|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
73870727|NCT05723263|147285668|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73870728|NCT05723263|147285669|OTHER|||||||0.727|||||||t-test, 2 sided|||||||0.727
73870729|NCT03375489|147285677|EQUIVALENCE|Equivalence was established for patient-reported quality of life if the 90% confidence interval for the estimated difference in means was within the margin of ±4 points on the Functional Assessment of Cancer Therapy - Lung Questionnaire.|Mean Difference (Final Values)|2.0||||0.04|TWO_SIDED|90.0|0.1|3.9||The a priori threshold for statistical significance was p\<0.05.|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment and controlling for baseline Functional Assessment of Cancer Therapy - Lung Questionnaire scores.||3.9|0.1|0.04
73870730|NCT03375489|147285678|EQUIVALENCE|Equivalence was established for patient-reported communication with their clinicians about their end-of-life care preferences if the 90% confidence interval for the estimated difference in proportions was within the margin of ±8%.|Estimated Difference in Proportions|3.1||||0.26|TWO_SIDED|90.0|-1.8|8.1||Bonferroni-adjusted p-value|binomial generalized estimating equation|||The difference between groups in the proportions of patients reporting that they communicated with their clinicians about their end-of-life care preferences was estimated using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.||8.1|-1.8|0.26
73870731|NCT03375489|147285679|EQUIVALENCE|Equivalence was established for patient length of stay in hospice if the 90% confidence interval for the estimated difference in mean days was within the margin of ±6 days.|Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|90.0|-7.0|7.4||Bonferroni-adjusted p-value|Regression, Linear|||The difference in mean length of stay in hospice between groups was estimated using a linear regression model with a main effect for group assignment.||7.4|-7.0|0.46
73870732|NCT03375489|147285680|SUPERIORITY||Difference in estimated proportions|-13.0|||<|0.001|TWO_SIDED|95.0|-17.6|-8.6||Bonferroni-adjusted p-value|binomial generalized estimating equation|||The proportion of palliative care visits with caregiver participation was compared using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.||-8.6|-17.6|<0.001
73949491|NCT00806624|147432981|SUPERIORITY_OR_OTHER||difference in percentages|-3.5|||||TWO_SIDED|95.0|-16.2|9.4||||||||9.4|-16.2|
73949492|NCT00806624|147432981|SUPERIORITY_OR_OTHER||difference in percentages|-9.1|||||TWO_SIDED|95.0|-22.4|4.5||||||||4.5|-22.4|
73949493|NCT00806624|147432981|SUPERIORITY_OR_OTHER||difference in percentage|-5.6|||||TWO_SIDED|95.0|-19.3|8.2||||||||8.2|-19.3|
73949494|NCT01702428|147433015|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|-0.54|||||TWO_SIDED|95.0|-1.69|0.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||0.58|-1.69|
73949495|NCT01702428|147433015|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|0.79|||||TWO_SIDED|95.0|-0.35|1.98|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||1.98|-0.35|
74009128|NCT03492554|147568951|OTHER||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of visual display= 0.8 H1: agreement proportion of visual display\> 0.8 Under the assumption that the true population agreement proportion of visual display was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.||||<0.0001
73870733|NCT03375489|147285681|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.99|TWO_SIDED|95.0|-1.0|1.7||Bonferroni-adjusted p-value|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.||1.7|-1.0|>0.99
73949496|NCT01702428|147433015|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|0.25|||||TWO_SIDED|95.0|-0.98|1.5|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||1.50|-0.98|
73949497|NCT01702428|147433016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.06|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to measles virus at Day 42.||1.06|0.91|
73870734|NCT03375489|147285682|SUPERIORITY||Mean Difference (Final Values)|0.4|||>|0.99|TWO_SIDED|95.0|-1.5|2.3||Bonferroni-adjusted p-value|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.||2.3|-1.5|>0.99
73870735|NCT00145574|147285702|SUPERIORITY_OR_OTHER|||||||0.1122|||||||ANCOVA|||The primary null hypotheses were tested sequentially in the following order: 1) no difference between the high-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with the last observation carried forward (LOCF) and 2) no difference between the low-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with LOCF. The hypotheses were tested at a 2-sided significance level of 5%.||||0.1122
73870736|NCT00145574|147285702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
73870737|NCT00145574|147285703|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||ANCOVA|||||||0.5260
73870738|NCT00145574|147285703|SUPERIORITY_OR_OTHER|||||||0.0085||95.0|||||ANCOVA|||||||0.0085
73870739|NCT00145574|147285704|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
73870740|NCT00145574|147285704|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||||||0.0008
73870741|NCT00145574|147285705|SUPERIORITY_OR_OTHER|||||||0.0155||95.0|||||ANCOVA|||||||0.0155
73870742|NCT00145574|147285705|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
73870743|NCT00145574|147285706|SUPERIORITY_OR_OTHER|||||||0.3482||95.0|||||ANCOVA|||||||0.3482
73949498|NCT01702428|147433016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.97|||||TWO_SIDED|95.0|0.9|1.05|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to measles virus at Day 42.||1.05|0.90|
73949499|NCT01702428|147433016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.94|1.09|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to measles virus at Day 42.||1.09|0.94|
73949500|NCT01702428|147433016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.06|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to measles virus at Day 42.||1.06|0.91|
73949501|NCT01702428|147433016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.03|||||TWO_SIDED|95.0|0.95|1.11|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to measles virus at Day 42.||1.11|0.95|
73949502|NCT01702428|147433016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.94|1.09|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to measles virus at Day 42.||1.09|0.94|
73870744|NCT00145574|147285706|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
73870745|NCT00145574|147285707|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|||||||0.0002
73870746|NCT00145574|147285707|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
73870747|NCT00145574|147285708|SUPERIORITY_OR_OTHER|||||||0.7433||95.0|||||ANCOVA|||||||0.7433
73870748|NCT00145574|147285708|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANCOVA|||||||0.0003
73870749|NCT01898013|147285725|SUPERIORITY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.25||0.02|TWO_SIDED|||||a priori threshold set at 0.05|Mixed Models Analysis|||||||0.02
73870750|NCT01898013|147285726|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.14||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
73870751|NCT01898013|147285727|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.12||0.79|TWO_SIDED||||||Mixed Models Analysis|||||||0.79
73870752|NCT01898013|147285728|SUPERIORITY||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||0.23
73949503|NCT01702428|147433017|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.02|||||TWO_SIDED|95.0|-1.05|1.09|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.09|-1.05|
73949504|NCT01702428|147433017|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.63|||||TWO_SIDED|95.0|-0.5|1.81|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.81|-0.50|
73949505|NCT01702428|147433017|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.61|||||TWO_SIDED|95.0|-0.53|1.79|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.79|-0.53|
73949506|NCT01702428|147433018|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|1.0|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to mumps virus at Day 42.||1.00|0.87|
73949507|NCT01702428|147433018|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.04|||||TWO_SIDED|95.0|0.97|1.11|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to mumps virus at Day 42.||1.11|0.97|
73949508|NCT01702428|147433018|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.07|||||TWO_SIDED|95.0|1.0|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to mumps virus at Day 42.||1.15|1.00|
73949509|NCT01702428|147433018|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.11|||||TWO_SIDED|95.0|1.04|1.19|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to mumps virus at Day 42.||1.19|1.04|
73949510|NCT01702428|147433018|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.96|||||TWO_SIDED|95.0|0.9|1.03|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to mumps virus at Day 42.||1.03|0.90|
73949511|NCT01702428|147433018|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.9|||||TWO_SIDED|95.0|0.84|0.96|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to mumps virus at Day 42.||0.96|0.84|
73949512|NCT01702428|147433019|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|0.14|||||TWO_SIDED|95.0|-1.3|1.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||1.58|-1.3|
73949513|NCT01702428|147433019|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.49|||||TWO_SIDED|95.0|-1.86|0.86|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||0.86|-1.86|
73949514|NCT01702428|147433019|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.62|||||TWO_SIDED|95.0|-2.02|0.74|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||0.74|-2.02|
74009129|NCT03492554|147568952|OTHER||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of R wave amplitude = 0.8 H1: agreement proportion of R wave amplitude \> 0.8 Under the assumption that the true population agreement proportion of R wave amplitude was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.||||<0.0001
73949515|NCT01702428|147433020|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||TWO_SIDED|95.0|1.01|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||"Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to rubella virus at Day 42.~."||1.15|1.01|
73870753|NCT01898013|147285729|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.13||0.63|TWO_SIDED||||||Mixed Models Analysis|||||||0.63
73870754|NCT01898013|147285730|SUPERIORITY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|0.13||0.62|TWO_SIDED||||||Mixed Models Analysis|||||||0.62
73870755|NCT04677504|147285733|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.51|1.14|||Regression, Cox|||"Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs.~eCCA vs. GBC), Geographic region (Asia vs. Rest of the World)."||1.14|0.51|
73870756|NCT04677504|147285734|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8857|TWO_SIDED|95.0|0.64|1.47|||Log Rank|||"Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs.~eCCA vs. GBC), Geographic region (Asia vs. Rest of the World)."||1.47|0.64|0.8857
73870757|NCT04677504|147285738|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|0.93|2.63|||Regression, Cox|||Quality of Life||2.63|0.93|
73870758|NCT04677504|147285738|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.48|1.36|||Regression, Cox|||Physical Function Scale||1.36|0.48|
73870759|NCT04677504|147285738|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.68|1.85|||Regression, Cox|||Role Function Scale||1.85|0.68|
73870760|NCT03182907|147285743|OTHER|The AUC0-inf of bezlotoxumab in Cohort 1 was compared to the AUC0-inf of bezlotoxumab in adults using an analysis of variance (ANOVA) model. The comparison adult PK dataset used was based on participants from 2 adult trials (NCT01241552 and NCT01513239) as a historical control.|Geometric Mean Ratio (GMR)|1.06|||||TWO_SIDED|90.0|0.95|1.18|||||GMR was calculated as the Cohort 1 geometric mean (GM) AUC0-inf / Adult GM AUC0-inf.|||1.18|0.95|
73870761|NCT03182907|147285743|OTHER|The AUC0-inf of bezlotoxumab in Cohort 2 was compared to the AUC0-inf of bezlotoxumab in adults using an analysis of variance (ANOVA) model. The comparison adult PK dataset used was based on participants from 2 adult trials (NCT01241552 and NCT01513239) as a historical control.|GMR|0.82|||||TWO_SIDED|90.0|0.75|0.89|||||GMR was calculated as the Cohort 2 GM AUC0-inf / Adult GM AUC0-inf.|||0.89|0.75|
73870762|NCT03182907|147285744|OTHER|Miettinen \& Nurminen method was used to generate the estimated difference in percentage and associated 95% confidence intervals (CIs) in bezlotoxumab versus placebo arms.|Difference in percentage|-5.7|||||TWO_SIDED|95.0|-14.5|7.7||||||||7.7|-14.5|
73870763|NCT03182907|147285745|OTHER|Miettinen \& Nurminen method was used to generate the estimated difference in percentage and associated 95% CIs in bezlotoxumab versus placebo arms.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-9.7|3.5||||||||3.5|-9.7|
73949516|NCT01702428|147433020|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.94|1.07|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to rubella virus at Day 42.||1.07|0.94|
73949517|NCT01702428|147433020|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to rubella virus at Day 42.||0.99|0.87|
73977782|NCT03924869|147501472|OTHER||Hazard Ratio (HR)|1.33||||0.93971|TWO_SIDED|95.0|0.93|1.9||1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.|Log Rank|Per protocol, since the EFS null hypothesis was not rejected, the OS hypothesis was not formally tested and the p-value should be considered nominal.||"Hazard ratio and 95% CIs were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery (medically inoperable versus refused surgery)."||1.90|0.93|0.93971
73870764|NCT03182907|147285746|OTHER|Miettinen and Nurminen method stratified by age cohort (12 to \<18 years of age, 1 to \<12 years of age) with a Cochran-Mantel-Haenszel weight was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|-3.7|||=|0.5701|TWO_SIDED|95.0|-20.0|8.0|||Stratified Miettinen and Nurminen method|||||8.0|-20.0|= 0.5701
73870765|NCT03182907|147285747|OTHER|Miettinen and Nurminen method stratified by age cohort (12 to \<18 years of age, 1 to \<12 years of age) with a Cochran-Mantel-Haenszel weight was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|0.8|||=|0.9165|TWO_SIDED|95.0|-11.8|17.6|||Stratified Miettinen and Nurminen method|||||17.6|-11.8|= 0.9165
73870766|NCT03182907|147285748|OTHER|Unstratified Miettinen and Nurminen method was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted Difference|-3.1|||=|0.6542|TWO_SIDED|95.0|-19.9|9.0|||Unstratified Miettinen & Nurminen method|||||9.0|-19.9|= 0.6542
73870767|NCT03182907|147285749|OTHER|Unstratified Miettinen and Nurminen method was used to generate treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|0.1|||=|0.9873|TWO_SIDED|95.0|-13.0|17.4|||Unstratified Miettinen & Nurminen method|||||17.4|-13.0|= 0.9873
73870768|NCT00112125|147285770|NON_INFERIORITY|The primary safety analysis was a test of the non-inferiority of CCM therapy compared to OMT with respect to the proportion of subjects experiencing death or hospitalization within 50 weeks using the Blackwelder non-inferiority test12 with a prespecified non-inferiority margin of 0.125.||||||0.31|||||||Fisher Exact|||||||0.31
74009130|NCT01196533|147568971|SUPERIORITY_OR_OTHER||||||||||||||||||All data in the outcome measure table is presenting the percentage of error.|||
73870769|NCT00112125|147285771|NON_INFERIORITY|The noninferiority margin was selected to be 12.5% and α was set at .05, which resulted in a sample size of 198 subjects per group. A percentage of subjects (∼7%) were expected to be lost to followup, so that a total sample size of 428 subjects (214 per group) was selected.||||||0.125|||||||Blackwelder|||||||0.125
73870770|NCT00870545|147285781|SUPERIORITY_OR_OTHER|||||||0.003||||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)||||.003
73870771|NCT00870545|147285782|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 and 12 months)||||.20
73870772|NCT00870545|147285783|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)||||<.001
73870773|NCT00870545|147285784|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, 12 months)||||.26
73870774|NCT00870545|147285785|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in scores over time (baseline, 6 months, and 12 months)||||.04
73949518|NCT01702428|147433020|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to rubella virus at Day 42.||0.99|0.87|
73949519|NCT01702428|147433020|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.93|1.07|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to rubella virus at Day 42.||1.07|0.93|
73949520|NCT01702428|147433020|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||TWO_SIDED|95.0|1.01|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to rubella virus at Day 42.||1.15|1.01|
73949521|NCT01702428|147433021|NON_INFERIORITY|The Lower Limit (LL) of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to measles virus.|Difference in seroresponse rate|0.18|||||TWO_SIDED|95.0|-0.68|1.25|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-measles antibody concentration at Day 42.||1.25|-0.68|
73977783|NCT03924869|147501473|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.74|1.42||Per protocol, there was no hypothesis pre-specified for TDDM to be formally tested.||||"Hazard ratio and 95% CIs were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery (medically inoperable versus refused surgery)."||1.42|0.74|
73977784|NCT03924869|147501476|OTHER||Mean Difference (Final Values)|-1.21||||0.5187|TWO_SIDED|95.0|-4.9|2.48|||cLDA model|||"Stats:~LS Mean change and 95% CIs were based on a constrained longitudinal data analysis (cLDA) model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery)."||2.48|-4.90|0.5187
74089300|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.68|3.73|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.73|1.68|<.0001
73870775|NCT00870545|147285786|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, and 12 months)||||.10
73870776|NCT04230213|147285787|EQUIVALENCE|Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.|Geometric mean ratio (percentage)|102.56|||||TWO_SIDED|90.0|89.78|117.17|||||Analysis was performed using analysis of variance (ANOVA) model.|||117.17|89.78|
73949522|NCT01702428|147433022|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.93|1.05|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to measles virus at Day 42.||1.05|0.93|
74009131|NCT00529451|147569014|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-2.44|||||TWO_SIDED|95.0|-3.63|-1.25||||||||-1.25|-3.63|
74009132|NCT00529451|147569015|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-0.86|||||TWO_SIDED|95.0|-2.06|0.34||||||||0.34|-2.06|
73870777|NCT04230213|147285788|EQUIVALENCE|Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.|Geometric mean ratio (Percentage)|105.31|||||TWO_SIDED|90.0|89.16|124.39|||||Analysis was performed using ANOVA model.|||124.39|89.16|
73870778|NCT01957202|147285854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.255|||<|0.0001|TWO_SIDED|95.0|-2.895|-1.616|||Mixed Model ANOVA|||||-1.616|-2.895|<0.0001
73870779|NCT01957202|147285854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.566|||<|0.0001|TWO_SIDED|95.0|-3.208|-1.925|||Mixed Model ANOVA|||||-1.925|-3.208|<0.0001
73870780|NCT01957202|147285854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.531||||0.0003|TWO_SIDED|95.0|-2.342|-0.719|||Mixed Model ANOVA|||||-0.719|-2.342|0.0003
73870781|NCT01957202|147285854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.842|||<|0.0001|TWO_SIDED|95.0|-2.654|-1.029|||Mixed Model ANOVA|||||-1.029|-2.654|<0.0001
73870782|NCT01957202|147285854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.097|||<|0.0001|TWO_SIDED|95.0|-4.857|-3.337|||Mixed Model ANOVA|||||-3.337|-4.857|<0.0001
73977785|NCT03924869|147501477|OTHER||Mean Difference (Final Values)|-4.34||||0.0906|TWO_SIDED|95.0|-9.38|0.69|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||0.69|-9.38|0.0906
73977786|NCT03924869|147501478|OTHER||Mean Difference (Final Values)|1.24||||0.5482|TWO_SIDED|95.0|-2.83|5.31|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||5.31|-2.83|0.5482
73870783|NCT01957202|147285854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.311||||0.3699|TWO_SIDED|95.0|-0.994|0.372|||Mixed Model ANOVA|||||0.372|-0.994|0.3699
73870784|NCT01957202|147285855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.364|||<|0.0001|TWO_SIDED|95.0|-1.853|-0.874|||Mixed Model ANOVA|||||-0.874|-1.853|<0.0001
73870785|NCT01957202|147285855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.1975|TWO_SIDED|95.0|-0.169|0.809|||Mixed Model ANOVA|||||0.809|-0.169|0.1975
73870786|NCT01957202|147285855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.252|||<|0.0001|TWO_SIDED|95.0|-1.87|-0.635|||Mixed Model ANOVA|||||-0.635|-1.870|<0.0001
73870787|NCT01957202|147285855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.432||||0.1648|TWO_SIDED|95.0|-0.179|1.042|||Mixed Model ANOVA|||||1.042|-0.179|0.1648
73870788|NCT01957202|147285855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.932||||0.0016|TWO_SIDED|95.0|-1.506|-0.358|||Mixed Model ANOVA|||||-0.358|-1.506|0.0016
73870789|NCT01957202|147285855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.684|||<|0.0001|TWO_SIDED|95.0|1.16|2.208|||Mixed Model ANOVA|||||2.208|1.160|<0.0001
73870790|NCT01957202|147285856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.3052|TWO_SIDED|95.0|-0.508|0.16|||Mixed Model ANOVA|||||0.160|-0.508|0.3052
73870791|NCT01957202|147285856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.2725|TWO_SIDED|95.0|-0.149|0.523|||Mixed Model ANOVA|||||0.523|-0.149|0.2725
73870792|NCT01957202|147285856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.536||||0.0118|TWO_SIDED|95.0|-0.952|-0.12|||Mixed Model ANOVA|||||-0.120|-0.952|0.0118
73870793|NCT01957202|147285856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.175||||0.4049|TWO_SIDED|95.0|-0.588|0.239|||Mixed Model ANOVA|||||0.239|-0.588|0.4049
73870794|NCT01957202|147285856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.349||||0.0793|TWO_SIDED|95.0|-0.739|0.041|||Mixed Model ANOVA|||||0.041|-0.739|0.0793
73870795|NCT01957202|147285856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.361||||0.0478|TWO_SIDED|95.0|0.004|0.719|||Mixed Model ANOVA|||||0.719|0.004|0.0478
73870796|NCT01957202|147285857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215||||0.1502|TWO_SIDED|95.0|-0.509|0.079|||Mixed Model ANOVA|||||0.079|-0.509|0.1502
73870797|NCT01957202|147285857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075||||0.6177|TWO_SIDED|95.0|-0.37|0.221|||Mixed Model ANOVA|||||0.221|-0.370|0.6177
73870798|NCT01957202|147285857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.701||||0.0004|TWO_SIDED|95.0|-1.08|-0.322|||Mixed Model ANOVA|||||-0.322|-1.080|0.0004
73870799|NCT01957202|147285857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0035|TWO_SIDED|95.0|-0.934|-0.187|||Mixed Model ANOVA|||||-0.187|-0.934|0.0035
74089301|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.45|3.1|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.45|<.0001
73977787|NCT03924869|147501479|OTHER||Mean Difference (Final Values)|-0.99||||0.7253|TWO_SIDED|95.0|-6.5|4.53|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||4.53|-6.50|0.7253
73870800|NCT01957202|147285857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.775|||<|0.0001|TWO_SIDED|95.0|-1.123|-0.428|||Mixed Model ANOVA|||||-0.428|-1.123|<0.0001
73870801|NCT01957202|147285857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.3807|TWO_SIDED|95.0|-0.175|0.456|||Mixed Model ANOVA|||||0.456|-0.175|0.3807
73870802|NCT01456169|147285858|SUPERIORITY_OR_OTHER||LS mean difference|-14.7|||<|0.001|TWO_SIDED|95.0|-17.6|-11.8|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate.||The type I error was controlled using a 2-step hierarchical testing procedure. In the first step, the high dose (40/25 mg) of Azilsartan medoxomil + chlorthalidone was compared to Azilsartan medoxomil alone. If the comparison in step 1 was statistically significant at a significance level of 5%, then step 2 was performed by comparing the low dose (40/12.5 mg) and monotherapy at the 5% significance level.||-11.8|-17.6|<0.001
73870803|NCT01456169|147285858|SUPERIORITY_OR_OTHER||LS mean difference|-9.5|||<|0.001|TWO_SIDED|95.0|-12.4|-6.5|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate||||-6.5|-12.4|<0.001
74089302|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0014|TWO_SIDED|95.0|1.26|2.67|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.67|1.26|0.0014
74089303|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0008|TWO_SIDED|95.0|1.33|2.99|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.99|1.33|0.0008
74089304|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0005|TWO_SIDED|95.0|1.37|3.06|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.06|1.37|0.0005
74089305|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0127|TWO_SIDED|95.0|1.16|3.49|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.49|1.16|0.0127
73977788|NCT03924869|147501480|OTHER||Mean Difference (Final Values)|-0.21||||0.9055|TWO_SIDED|95.0|-3.7|3.28|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||3.28|-3.70|0.9055
73977789|NCT02542943|147501481|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.13||||0.435|TWO_SIDED|95.0|-0.4|0.134||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|||0.134|-0.400|0.4350
73977790|NCT02542943|147501481|SUPERIORITY_OR_OTHER||LS mean difference|0.07||||0.7605|TWO_SIDED|95.0|-0.192|0.34||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|||0.340|-0.192|0.7605
73977791|NCT02542943|147501482|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.0873|TWO_SIDED|95.0|-0.445|0.031||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.031|-0.445|0.0873
73977792|NCT02542943|147501483|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.4921|TWO_SIDED|95.0|-0.27|0.13||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.130|-0.270|0.4921
73977793|NCT02542943|147501483|SUPERIORITY_OR_OTHER||LS mean difference|0.02||||0.8728|TWO_SIDED|95.0|-0.183|0.216||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.216|-0.183|0.8728
73977794|NCT02542943|147501483|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.4003|TWO_SIDED|95.0|-0.287|0.115||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.115|-0.287|0.4003
74089306|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|2.11||||0.0075|TWO_SIDED|95.0|1.22|3.64|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.64|1.22|0.0075
74089307|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0061|TWO_SIDED|95.0|1.17|2.52|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.52|1.17|0.0061
74089308|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0007|TWO_SIDED|95.0|1.33|2.88|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.88|1.33|0.0007
73977795|NCT02542943|147501484|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.8106|TWO_SIDED|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|0.000|0.8106
73977796|NCT02542943|147501484|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1656|TWO_SIDED|95.0|-5.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.1656
73977797|NCT02542943|147501484|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1419|TWO_SIDED|95.0|0.0|5.0|||Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.1419
74009133|NCT00529451|147569016|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-1.48|||||TWO_SIDED|95.0|-2.67|-0.28||||||||-0.28|-2.67|
73949523|NCT01702428|147433023|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to mumps virus.|Difference in seroresponse rate|0.81|||||TWO_SIDED|95.0|-0.1|1.96|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-mumps antibody concentration at Day 42.||1.96|-0.1|
73949524|NCT01702428|147433024|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to mumps virus.|Adjusted GMC ratio|1.05|||||TWO_SIDED|95.0|0.99|1.11|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to mumps virus at Day 42.||1.11|0.99|
73949525|NCT01702428|147433025|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to rubella virus.|Difference in seroresponse rate|-1.15|||||TWO_SIDED|95.0|-2.0|-0.15|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-rubella antibody concentration at Day 42.||-0.15|-2.00|
73949526|NCT01702428|147433026|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.87|||||TWO_SIDED|95.0|0.83|0.92|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to rubella virus at Day 42.||0.92|0.83|
73949527|NCT01702428|147433027|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (pooled INV\_MMR Group minus pooled COM\_MMR Group) should be ≥-10% for antibodies to VZV.|Difference in seroresponse rate|1.3|||||TWO_SIDED|95.0|-1.31|4.29|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|In US sub-cohort: Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-VZV antibody concentration at Day 42.||4.29|-1.31|
73949528|NCT01702428|147433028|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to VZV.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.95|1.08|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to VZV virus at Day 42.||1.08|0.95|
73949529|NCT01702428|147433030|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) was ≥0.5 for antibodies to HAV virus.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.86|1.11|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to HAV virus at Day 42.||1.11|0.86|
73949530|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.85|1.05|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 1 antibody at Day 42.||1.05|0.85|
73949531|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.08|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 3 antibody at Day 42.||1.08|0.91|
73949532|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.88||||||95.0|0.79|0.98|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 4 antibody at Day 42.||0.98|0.79|
73949533|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||TWO_SIDED|95.0|0.83|1.01|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 5 antibody at Day 42.||1.01|0.83|
73949534|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.92|1.11|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 6A antibody at Day 42.||1.11|0.92|
73949535|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.89|1.09|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 6B antibody at Day 42.||1.09|0.89|
73977798|NCT02542943|147501485|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5631|TWO_SIDED|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.5631
73977799|NCT02542943|147501485|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.8423|TWO_SIDED|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|0.000|0.8423
74009134|NCT02101515|147569017|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45|||||TWO_SIDED|95.0|0.22|0.93||||||||0.93|0.22|
74009135|NCT02101515|147569019|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.41|||||TWO_SIDED|95.0|0.67|8.4||||||||8.40|0.67|
73870804|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was greater than (\>) -0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.2|2.1||||||Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95 percent (%) confidence interval (CI).||2.1|-2.2|
73949536|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 7F antibody at Day 42.||1.03|0.86|
73949537|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.9|1.08|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 9V antibody at Day 42.||1.08|0.90|
73949538|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.91|||||TWO_SIDED|95.0|0.81|1.02|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 14 antibody at Day 42.||1.02|0.81|
73949539|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||TWO_SIDED|95.0|0.84|1.02|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 18C antibody at Day 42.||1.02|0.84|
73949540|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.97|||||TWO_SIDED|95.0|0.87|1.07|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 19A antibody at Day 42.||1.07|0.87|
73949541|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.96|||||TWO_SIDED|95.0|0.87|1.06|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 19F antibody at Day 42.||1.06|0.87|
73949542|NCT01702428|147433031|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.95|||||TWO_SIDED|95.0|0.85|1.06|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 23F antibody at Day 42.||1.06|0.85|
73949543|NCT00574990|147433078|SUPERIORITY_OR_OTHER||chi square|12.99|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|||||Differences between roles and communication event content were assessed by Chi squared|Chi-squared|||Descriptive counts and chi squared were done on the observation data.||||0.01
73977800|NCT02542943|147501485|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.439|TWO_SIDED|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.4390
73977801|NCT02542943|147501486|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.517|TWO_SIDED|95.0|-0.611|0.308||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.308|-0.611|0.5170
73977802|NCT02542943|147501486|SUPERIORITY_OR_OTHER||LS mean difference|0.17||||0.4538|TWO_SIDED|95.0|-0.284|0.633||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.633|-0.284|0.4538
74009136|NCT02101515|147569020|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.41|1.45||||||||1.45|0.41|
74009137|NCT02101515|147569021|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.71|||||TWO_SIDED|95.0|1.3|5.62||||||||5.62|1.30|
73870805|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-1.7|||||TWO_SIDED|95.0|-5.2|1.1||||||Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||1.1|-5.2|
73949544|NCT01355419|147433080|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||A power analysis conducted prior to the study predicted that a sample of 144 patients would provide an 80% power to detect a mean difference in sleep time of 40 minutes, assuming a standard deviation of 85 minutes and using a two-sided significance level of 5%.||||<0.05
73949545|NCT01355419|147433081|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.|Regression, Linear|||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.||||<0.05
73870806|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
73870807|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
73870808|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
73870809|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.3|||||TWO_SIDED|95.0|-1.1|6.3||||||Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||6.3|-1.1|
73870810|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-0.6|||||TWO_SIDED|95.0|-4.2|2.9||||||Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.9|-4.2|
73870811|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|0.9|7.3||||||Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|0.9|
73870812|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.9|||||TWO_SIDED|95.0|-0.2|6.7||||||Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||6.7|-0.2|
73870813|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.9|||||TWO_SIDED|95.0|-0.2|6.7||||||Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||6.7|-0.2|
73949546|NCT00919893|147433102|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis: Cernilton compared to placebo induces a better or the same outcome of symptomatic improvement in the pain domain of symptomatic Pelvic Pain Syndrome verified by the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI).~Power calculation: A power of 1-beta=0.8 was calculated."||||<0.05
73949547|NCT01275196|147433114|NON_INFERIORITY_OR_EQUIVALENCE|This trial was powered to detect an odds ratio of at least 2.333 which corresponds, for example, to increases of 18% (from 22% to 40%) and increases of 20% (from 30% to 50%).||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
73949548|NCT02572817|147433137|SUPERIORITY||Odds Ratio (OR)|1.22||||0.54|TWO_SIDED|95.0|0.65|2.29|||Regression, Logistic|||||2.29|0.65|0.54
73949549|NCT02572817|147433138|SUPERIORITY||Odds Ratio (OR)|0.86||||0.66|TWO_SIDED|95.0|0.45|1.66|||Regression, Logistic|||||1.66|0.45|0.66
73870814|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|1.7|||||TWO_SIDED|95.0|-1.9|5.8||||||Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||5.8|-1.9|
73870815|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|0.9|7.3||||||Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|0.9|
73949550|NCT02572817|147433139|SUPERIORITY||Odds Ratio (OR)|0.95||||0.87|TWO_SIDED|95.0|0.5|1.8|||Regression, Logistic|||||1.8|0.5|0.87
73949551|NCT02572817|147433140|SUPERIORITY||Odds Ratio (OR)|1.26||||0.49|TWO_SIDED|95.0|0.65|2.41|||Regression, Logistic|||||2.41|0.65|0.49
73949552|NCT02572817|147433141|SUPERIORITY||Odds Ratio (OR)|1.07||||0.83|TWO_SIDED|95.0|0.55|2.08|||Regression, Logistic|||||2.08|0.55|0.83
73949553|NCT02572817|147433142|SUPERIORITY||Odds Ratio (OR)|1.29||||0.47|TWO_SIDED|95.0|0.65|2.56|||Regression, Logistic|||||2.56|0.65|0.47
73949554|NCT02572817|147433143|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
73949555|NCT02572817|147433144|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.64|TWO_SIDED|95.0|0.21|2.64|||Log Rank|||||2.64|0.21|0.64
73949556|NCT02572817|147433145|SUPERIORITY|||||||0.69|||||||Fisher Exact|||||||0.69
73949557|NCT02572817|147433146|SUPERIORITY||Odds Ratio (OR)|1.33||||0.43|TWO_SIDED|95.0|0.65|2.71|||Regression, Logistic|||Composite mortality and hospitalization, Day 7||2.71|0.65|0.43
73949558|NCT02572817|147433146|SUPERIORITY||Odds Ratio (OR)|1.11||||0.79|TWO_SIDED|95.0|0.5|2.48|||Regression, Logistic|||Composite mortality and hospitalization, Day 14||2.48|0.5|0.79
73949559|NCT02572817|147433146|SUPERIORITY||Odds Ratio (OR)|1.65||||0.29|TWO_SIDED|95.0|0.66|4.12|||Regression, Logistic|||Composite mortality and hospitalization, Day 28||4.12|0.66|0.29
73949560|NCT02572817|147433147|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.0||||0.2|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3||0|-2|0.2
73949561|NCT02572817|147433147|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.66|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3||1|-1|0.66
73949562|NCT02572817|147433148|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 3||||0.18
73949563|NCT02572817|147433148|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 7||||0.61
73949564|NCT02572817|147433149|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.68|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-2|0.68
73949565|NCT02572817|147433150|SUPERIORITY||Odds Ratio (OR)|1.42||||0.98|TWO_SIDED|95.0|0.23|11.01|||Regression, Logistic|||||11.01|0.23|0.98
73949566|NCT02572817|147433151|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.5||||0.37|TWO_SIDED|95.0|-6.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-6|0.37
73949567|NCT02572817|147433152|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
73949568|NCT02572817|147433153|SUPERIORITY||Hodges-Lehman estimate of location shift|-3.0||||0.22|TWO_SIDED|95.0|-14.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-14|0.22
73949569|NCT02572817|147433154|SUPERIORITY||Odds Ratio (OR)|0.74||||1|TWO_SIDED|95.0|0.08|9.29|||Regression, Logistic|||||9.29|0.08|1
73949570|NCT02572817|147433156|SUPERIORITY||Odds Ratio (OR)|0.33||||0.24|TWO_SIDED|95.0|0.05|1.79|||Regression, Logistic|||||1.79|0.05|0.24
73949571|NCT02572817|147433158|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73977803|NCT02542943|147501486|SUPERIORITY_OR_OTHER||LS mean difference|-0.33||||0.1663|TWO_SIDED|95.0|-0.788|0.136||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.136|-0.788|0.1663
73977804|NCT02542943|147501487|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.7137|TWO_SIDED|95.0|-0.661|0.453||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.453|-0.661|0.7137
73977805|NCT02542943|147501487|SUPERIORITY_OR_OTHER||LS mean difference|0.1||||0.7353|TWO_SIDED|95.0|-0.46|0.651||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.651|-0.460|0.7353
74089309|NCT02697773|147731612|SUPERIORITY|The two comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|1.89||||0.001|TWO_SIDED|95.0|1.29|2.76|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.76|1.29|0.0010
73977806|NCT02542943|147501487|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.4843|TWO_SIDED|95.0|-0.76|0.361||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.361|-0.760|0.4843
73949572|NCT02572817|147433159|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.06|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 3||0|-1|0.06
73977807|NCT01836445|147501519|SUPERIORITY||Prevalence Ratio|0.9||||0.2|TWO_SIDED|95.0|0.76|1.06|||Regression, Logistic|||||1.06|0.76|0.20
73977808|NCT01836445|147501520|SUPERIORITY||Prevalence Ratio|0.95||||0.6|TWO_SIDED|95.0|0.8|1.14|||Regression, Logistic|||||1.14|0.80|0.60
73977809|NCT01836445|147501521|SUPERIORITY||Prevalence Ratio|0.83||||0.04|TWO_SIDED|95.0|0.7|0.99|||Regression, Logistic|||||0.99|0.70|0.04
73977810|NCT01836445|147501523|SUPERIORITY||Risk Ratio (RR)|0.6||||0.01|TWO_SIDED|95.0|0.38|0.95|||Z-test|||||0.95|0.38|0.01
73949573|NCT02572817|147433159|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.0||||0.13|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 7||0|-1|0.13
73949574|NCT02572817|147433160|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 3||||0.36
73949575|NCT02572817|147433160|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 7||||0.15
73949576|NCT02572817|147433161|SUPERIORITY||Odds Ratio (OR)|1.73||||0.12|TWO_SIDED|95.0|0.87|3.44|||Regression, Logistic|||||3.44|0.87|0.12
73949577|NCT02572817|147433162|SUPERIORITY||Odds Ratio (OR)|0.47||||0.23|TWO_SIDED|95.0|0.13|1.43|||Regression, Logistic|||||1.43|0.13|0.23
73949578|NCT05462652|147433167|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|-3.68|-1.59|||Mixed Models Analysis|||||-1.59|-3.68|<0.001
73949579|NCT05462652|147433168|SUPERIORITY||Difference in proportion z-test|20.1|||<|0.001|TWO_SIDED|95.0|9.1|31.0|||Chi-squared|||"Missing values imputed with multiple imputation.~P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test."||31.0|9.1|<0.001
73949580|NCT05462652|147433169|SUPERIORITY||Difference in proportions z-test|15.4||||0.003|TWO_SIDED|95.0|5.3|25.6|||Chi-squared|||P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test.||25.6|5.3|0.003
73949581|NCT05462652|147433170|SUPERIORITY||Difference in proportion z-test|24.7|||<|0.001|TWO_SIDED|95.0|13.0|36.4|||Chi-squared|||Missing values imputed with multiple imputation. P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test.||36.4|13.0|<0.001
73949582|NCT04548531|147433175|SUPERIORITY||Mean Difference (Final Values)|0.67|||<|0.001|TWO_SIDED|95.0|0.41|0.94|||t-test, 2 sided|||||0.94|0.41|<.001
73949583|NCT04548531|147433176|SUPERIORITY||Risk Difference (RD)|21.0||||0.003|TWO_SIDED|95.0|7.0|35.0|||Chi-squared|||||35|7|0.003
73870816|NCT01200368|147285889|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|1.0|7.3||||||Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|1.0|
73949584|NCT04548531|147433177|SUPERIORITY||Risk Difference (RD)|3.0||||0.75|TWO_SIDED|95.0|-10.0|16.0|||Chi-squared|||We tested for a clear preference for screening, if a patient chose a colonoscopy or a stool-based test vs. the other response options.||16|-10|.75
74089310|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0411|TWO_SIDED|95.0|1.02|2.31|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.02|0.0411
73949585|NCT04548531|147433178|SUPERIORITY||Risk Difference (RD)|11.0||||0.14|TWO_SIDED|95.0|-3.0|26.0|||Chi-squared|||We categorized for likelihood to follow through with screening. We reported on results from patients who indicated 'Very Likely' on their response option vs. the other options (likely, unsure, unlikely, very unlikely)||26|-3|0.14
73949586|NCT04548531|147433179|SUPERIORITY||Risk Difference (RD)|13.0|||<|0.001|TWO_SIDED|95.0|6.0|18.0|||Chi-squared|||Assessed how many patients completed any colorectal cancer screening test within 6-months after randomization.||18|6|<.001
73949587|NCT02761629|147433180|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.7||||0.0536|TWO_SIDED|95.0|-0.01|26.6|||Fisher Exact||Exact 95% confidence interval was from the binomial distribution for response rate.|||26.6|-0.01|0.0536
73949588|NCT02761629|147433183|SUPERIORITY_OR_OTHER|||||||0.0175|||||||Fisher Exact|||||||0.0175
73949589|NCT02001974|147433195|OTHER|||||||0.0341|||||||ANOVA|||DF1681Y Cmax at Day -3||||0.0341
73949590|NCT02001974|147433195|OTHER|||||||0.0636|||||||ANOVA|||DF1681Y Cmax at Day -3||||0.0636
73949591|NCT02001974|147433195|OTHER|||||||0.0487|||||||ANOVA|||DF1681Y Cmax at Day 1||||0.0487
73949592|NCT02001974|147433195|OTHER|||||||0.3498|||||||ANOVA|||DF1681Y Cmax at Day 1||||0.3498
73949593|NCT02001974|147433195|OTHER|||||||0.0096|||||||ANOVA|||DF1681Y Cmax at Day 8||||0.0096
73949594|NCT02001974|147433195|OTHER|||||||0.1374|||||||ANOVA|||DF1681Y Cmax at Day 8||||0.1374
73949595|NCT02001974|147433195|OTHER|||||||0.0065|||||||ANOVA|||DF1681Y Cmax at Day 21||||0.0065
73949596|NCT02001974|147433195|OTHER|||||||0.147|||||||ANOVA|||DF1681Y Cmax at Day 21||||0.1470
73949597|NCT02001974|147433196|OTHER|||||||0.0015|||||||ANOVA|||DF2243 Cmax at Day -3||||0.0015
73949598|NCT02001974|147433196|OTHER|||||||0.0176|||||||ANOVA|||DF2243 Cmax at Day -3||||0.0176
73949599|NCT02001974|147433196|OTHER|||||||0.0048|||||||ANOVA|||DF2243 Cmax at Day 1||||0.0048
73949600|NCT02001974|147433196|OTHER|||||||0.2083|||||||ANOVA|||DF2243 Cmax at Day 1||||0.2083
73949601|NCT02001974|147433196|OTHER|||||||0.0111|||||||ANOVA|||DF2243 Cmax at Day 8||||0.0111
73949602|NCT02001974|147433196|OTHER|||||||0.1441|||||||ANOVA|||DF2243 Cmax at Day 8||||0.1441
73949603|NCT02001974|147433196|OTHER|||||||0.0283|||||||ANOVA|||DF2243 Cmax at Day 21||||0.0283
73949604|NCT02001974|147433196|OTHER|||||||0.1331|||||||ANOVA|||DF2243 Cmax at Day 21||||0.1331
73949605|NCT02001974|147433197|OTHER|||||||0.0097|||||||ANOVA|||DF2188Y, Cmax, Day -3||||0.0097
73949606|NCT02001974|147433197|OTHER|||||||0.0354|||||||ANOVA|||DF2188Y, Cmax, Day -3||||0.0354
73949607|NCT02001974|147433197|OTHER|||||||0.02|||||||ANOVA|||DF2188Y, Cmax, Day 1||||0.0200
73949608|NCT02001974|147433197|OTHER|||||||0.2134|||||||ANOVA|||DF2188Y, Cmax, Day 1||||0.2134
73949609|NCT02001974|147433197|OTHER|||||||0.0235|||||||ANOVA|||DF2188Y, Cmax, Day 8||||0.0235
73949610|NCT02001974|147433197|OTHER|||||||0.0964|||||||ANOVA|||DF2188Y, Cmax, Day 8||||0.0964
73949611|NCT02001974|147433197|OTHER|||||||0.0314|||||||ANOVA|||DF2188Y, Cmax, Day 21||||0.0314
73949612|NCT02001974|147433197|OTHER|||||||0.0773|||||||ANOVA|||DF2188Y, Cmax, Day 21||||0.0773
73949613|NCT02001974|147433198|OTHER|||||||0.1016|||||||ANOVA|||Cmax, ibuprofen, Day -3||||0.1016
73949614|NCT02001974|147433198|OTHER|||||||0.2001|||||||ANOVA|||Cmax, ibuprofen, Day -3||||0.2001
73949615|NCT02001974|147433198|OTHER|||||||0.0802|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.0802
73949616|NCT02001974|147433198|OTHER|||||||0.4728|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.4728
73949617|NCT02001974|147433198|OTHER|||||||0.0355|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.0355
73949618|NCT02001974|147433198|OTHER|||||||0.1709|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.1709
73949619|NCT02001974|147433198|OTHER|||||||0.0685|||||||ANOVA|||Cmax, ibuprofen, Day 21||||0.0685
73949620|NCT02001974|147433198|OTHER|||||||0.3189|||||||ANOVA|||Cmax, ibuprofen, Day 21||||0.3189
73949621|NCT02001974|147433199|OTHER|||||||0.2375|||||||ANOVA|||Paclitaxel, Cmax, Day 1||||0.2375
73949622|NCT02001974|147433199|OTHER|||||||0.3608|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.3608
73949623|NCT02001974|147433199|OTHER|||||||0.0442|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.0442
73949624|NCT02001974|147433199|OTHER|||||||0.1067|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.1067
73949625|NCT02001974|147433205|OTHER|||||||0.0134|||||||ANOVA|||DF1681Y, AUC0-8, Day -3||||0.0134
73949626|NCT02001974|147433205|OTHER|||||||0.0799|||||||ANOVA|||DF1681Y, AUC0-8, Day -3||||0.0799
73949627|NCT02001974|147433205|OTHER|||||||0.0241|||||||ANOVA|||DF1681Y, AUC0-8, Day 1||||0.0241
73949628|NCT02001974|147433205|OTHER|||||||0.01384|||||||ANOVA|||DF1681Y, AUC0-8, Day 1||||0.01384
73949629|NCT02001974|147433205|OTHER|||||||0.0091|||||||ANOVA|||DF1681Y, AUC0-8, Day 8||||0.0091
73949630|NCT02001974|147433205|OTHER|||||||0.5687|||||||ANOVA|||DF1681Y, AUC0-8, Day 8||||0.5687
73949631|NCT02001974|147433205|OTHER|||||||0.0058|||||||ANOVA|||DF1681Y, AUC0-8, Day 21||||0.0058
73949632|NCT02001974|147433205|OTHER|||||||0.3667|||||||ANOVA|||DF1681Y, AUC0-8, Day 21||||0.3667
73949633|NCT02001974|147433206|OTHER|||||||0.0029|||||||ANOVA|||DF2243Y - AUC0-8 - Day -3||||0.0029
73949634|NCT02001974|147433206|OTHER|||||||0.0349|||||||ANOVA|||DF2243Y - AUC0-8 - Day -3||||0.0349
73949635|NCT02001974|147433206|OTHER|||||||0.0119|||||||ANOVA|||DF2243Y - AUC0-8 - Day 1||||0.0119
73949636|NCT02001974|147433206|OTHER|||||||0.21|||||||ANOVA|||DF2243Y - AUC0-8 - Day 1||||0.2100
73870817|NCT01200368|147285890|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for the IgG GMC ratio was \>0.5.|GMC ratio|0.81|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.94|0.71|
73870818|NCT01200368|147285890|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.79|||||TWO_SIDED|95.0|0.64|0.97||||||Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.97|0.64|
73870819|NCT01200368|147285890|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.74|||||TWO_SIDED|95.0|0.64|0.86||||||Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.86|0.64|
73870820|NCT01200368|147285890|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.70|
73870821|NCT01200368|147285890|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.73|||||TWO_SIDED|95.0|0.63|0.85||||||Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.85|0.63|
73870822|NCT01200368|147285890|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08||||||Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.08|0.72|
73870823|NCT01200368|147285890|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.66|0.98||||||Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.66|
73870824|NCT01200368|147285891|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
73870825|NCT01200368|147285891|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||2.2|-2.1|
73949637|NCT02001974|147433206|OTHER|||||||0.0165|||||||ANOVA|||DF2243Y - AUC0-8 - Day 8||||0.0165
73949638|NCT02001974|147433206|OTHER|||||||0.1496|||||||ANOVA|||DF2243Y - AUC0-8 - Day 8||||0.1496
73949639|NCT02001974|147433206|OTHER|||||||0.0321|||||||ANOVA|||DF2243Y - AUC0-8 - Day 21||||0.0321
73949640|NCT02001974|147433206|OTHER|||||||0.1404|||||||ANOVA|||DF2243Y - AUC0-8 - Day 21||||0.1404
73949641|NCT02001974|147433207|OTHER|||||||0.0081|||||||ANOVA|||AUC0-8 for DF2188Y, Day -3||||0.0081
73949642|NCT02001974|147433207|OTHER|||||||0.064|||||||ANOVA|||AUC0-8 for DF2188Y, Day -3||||0.0640
73949643|NCT02001974|147433207|OTHER|||||||0.0397|||||||ANOVA|||AUC0-8 for DF2188Y, Day 1||||0.0397
73949644|NCT02001974|147433207|OTHER|||||||0.1898|||||||ANOVA|||AUC0-8 for DF2188Y, Day 1||||0.1898
73949645|NCT02001974|147433207|OTHER|||||||0.025|||||||ANOVA|||AUC0-8 for DF2188Y, Day 8||||0.0250
73949646|NCT02001974|147433207|OTHER|||||||0.1605|||||||ANOVA|||AUC0-8 for DF2188Y, Day 8||||0.1605
73949647|NCT02001974|147433207|OTHER|||||||0.0786|||||||ANOVA|||AUC0-8 for DF2188Y, Day 21||||0.0786
73949648|NCT02001974|147433207|OTHER|||||||0.2652|||||||ANOVA|||AUC0-8 for DF2188Y, Day 21||||0.2652
73949649|NCT02001974|147433208|OTHER|||||||0.1335|||||||ANOVA|||Ibuprofen, AUC0-8, Day -3||||0.1335
73949650|NCT02001974|147433208|OTHER|||||||0.2658|||||||ANOVA|||Ibuprofen, AUC0-8, Day -3||||0.2658
73949651|NCT02001974|147433208|OTHER|||||||0.1063|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.1063
73949652|NCT02001974|147433208|OTHER|||||||0.4959|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.4959
73949653|NCT02001974|147433208|OTHER|||||||0.0452|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.0452
73949654|NCT02001974|147433208|OTHER|||||||0.2223|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.2223
73949655|NCT02001974|147433208|OTHER|||||||0.0737|||||||ANOVA|||Ibuprofen, AUC0-8, Day 21||||0.0737
73870826|NCT01200368|147285891|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
73870827|NCT01200368|147285891|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
73870828|NCT01200368|147285892|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.8|||||TWO_SIDED|95.0|1.5|2.15||||||Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.15|1.50|
73870829|NCT01200368|147285892|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.28|0.92|
73949656|NCT02001974|147433208|OTHER|||||||0.2804|||||||ANOVA|||Ibuprofen, AUC0-8, Day21||||0.2804
73949657|NCT02001974|147433209|OTHER|||||||0.1449|||||||ANOVA|||Paclitaxel, AUC0-8, Day 1||||0.1449
73949658|NCT02001974|147433209|OTHER|||||||0.1338|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.1338
73949659|NCT02001974|147433209|OTHER|||||||0.0633|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.0633
73949660|NCT02001974|147433209|OTHER|||||||0.6939|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.6939
73949661|NCT00119262|147433241|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|95.0|||||Fisher Exact|||||||0.12
73949662|NCT00119262|147433242|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Fisher Exact|||||||0.32
73949663|NCT01751113|147433272|SUPERIORITY_OR_OTHER||AUC ratio|1.158|||<|0.001|TWO_SIDED|95.0|1.1|1.219|||Mixed Models Analysis|||||1.219|1.100|<0.001
74089311|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.72||||0.009|TWO_SIDED|95.0|1.14|2.57|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|1.14|0.0090
73977811|NCT01836445|147501524|OTHER|Generalized Linear Mixed Model statistical test used||||||0.15|||||||Regression, Linear|||||||0.150
73977812|NCT01836445|147501525|OTHER|Generalized Linear Mixed Model statistical test used||||||0.374|||||||Regression, Linear|||||||0.374
73977813|NCT01836445|147501526|OTHER|Generalized Linear Mixed Model statistical test used||||||0.919|||||||Regression, Linear|||Analysis for Motivation items||||0.919
73977814|NCT01836445|147501526|OTHER|Generalized Linear Mixed Model statistical test used||||||0.493|||||||Regression, Linear|||Analysis for Social Norms items||||0.493
73977815|NCT01836445|147501526|OTHER|Generalized Linear Mixed Model statistical test used||||||0.002|||||||Regression, Linear|||Analysis for Behavioral Skills items||||0.002
73977816|NCT01836445|147501527|OTHER|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.067
73977817|NCT01836445|147501527|OTHER|Generalized Linear Mixed Model statistical test used||||||0.135|||||||Regression, Linear|||Analysis for Condom Use items||||0.135
73977818|NCT01836445|147501527|OTHER|Generalized Linear Mixed Model statistical test used||||||0.025|||||||Regression, Linear|||Analysis for HIV Testing items||||0.025
73977819|NCT01836445|147501528|OTHER|Generalized Linear Mixed Model statistical test used||||||0.138|||||||Regression, Logistic|||||||0.138
73977820|NCT01836445|147501529|OTHER|Generalized Linear Mixed Model statistical test used||||||0.173|||||||Regression, Linear|||||||0.173
74089312|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.6||||0.1149|TWO_SIDED|95.0|0.89|2.86|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.86|0.89|0.1149
73977821|NCT01836445|147501530|OTHER|Generalized Linear Mixed Model statistical test used||||||0.567|||||||Regression, Linear|||||||0.567
73977822|NCT01836445|147501531|OTHER|Generalized Linear Mixed Model statistical test used||||||0.861|||||||Regression, Linear|||Analysis for motivation items||||0.861
73977823|NCT01836445|147501531|OTHER|Generalized Linear Mixed Model statistical test used||||||0.628|||||||Regression, Linear|||Analysis for social norms items||||0.628
73977824|NCT01836445|147501531|OTHER|Generalized Linear Mixed Model statistical test used||||||0.151|||||||Regression, Linear|||Analysis for behavioral skills items||||0.151
73977825|NCT01836445|147501532|OTHER|Generalized Linear Mixed Model statistical test used||||||0.001|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.001
73977826|NCT01836445|147501532|OTHER|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Condom Use items||||0.067
73977827|NCT01836445|147501532|OTHER|Generalized Linear Mixed Model statistical test used||||||0.637|||||||Regression, Linear|||Analysis for HIV Testing items||||0.637
73977828|NCT01836445|147501533|OTHER|Generalized Linear Mixed Model statistical test used||||||0.862|||||||Regression, Linear|||||||0.862
73977829|NCT01836445|147501534|OTHER|Generalized Linear Mixed Model statistical test used||||||0.762|||||||Regression, Linear|||||||0.762
73977830|NCT01836445|147501535|SUPERIORITY|||||||0.043|||||||Regression, Linear|||Analysis for Motivation items||||0.043
73977831|NCT01836445|147501535|SUPERIORITY|||||||0.617|||||||Regression, Linear|||Analysis for Social Norm items||||0.617
73977832|NCT01836445|147501535|SUPERIORITY|||||||0.57|||||||Regression, Linear|||Analysis for Behavioral Skills items||||0.570
73977833|NCT01836445|147501536|SUPERIORITY|||||||0.036|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.036
73977834|NCT01836445|147501536|SUPERIORITY|||||||0.837|||||||Regression, Linear|||Analysis for Condom Use items||||0.837
73977835|NCT01836445|147501536|SUPERIORITY|||||||0.953|||||||Regression, Linear|||Analysis for HIV Testing items||||0.953
73977836|NCT01836445|147501537|SUPERIORITY|||||||0.719|||||||Regression, Linear|||||||0.719
73977837|NCT05200416|147501550|SUPERIORITY||Mean Difference (Final Values)|11.42|||<|0.001|TWO_SIDED|95.0|7.83|15.01|||Mixed Models Analysis|||||15.01|7.83|<0.001
73977838|NCT05200416|147501551|SUPERIORITY||Mean Difference (Final Values)|-4.16||||0.001|TWO_SIDED|95.0|-6.69|-1.63|||Mixed Models Analysis|||||-1.63|-6.69|0.001
73977839|NCT05986617|147501552|SUPERIORITY|||||||0.06429||||||2-tail t-test with non-equivalent variances|t-test, 2 sided|||Power calculation: 2 factor (group, time) ANOVA design with a group\*time interaction term to estimate the proposed sample size. Using a Cohen's effect size estimate for 2 groups with 5 time-points, a sample size of 40 per group will provide \>90% to detect a moderate effect size (0.25) for group, for time and for the group\*time interaction.||||.06429
73977840|NCT01767688|147501632|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.94|||||TWO_SIDED|95.0|0.79|1.11|||Geometric least-squares mean ratio (GMR)|||||1.11|0.79|
73977841|NCT01767688|147501633|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.94|||||TWO_SIDED|95.0|0.81|1.1|||Geometric least-squares mean ratio (GMR)|||||1.10|0.81|
73977842|NCT01767688|147501634|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.81|||||TWO_SIDED|95.0|0.51|1.28|||Geometric least-squares mean ratio (GMR)|||||1.28|0.51|
73977843|NCT01767688|147501635|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|1.03|||||TWO_SIDED|95.0|0.93|1.15|||Geometric least-squares mean ratio (GMR)|||||1.15|0.93|
73977844|NCT03392194|147501704|OTHER|The purpose of this small pilot randomized control trial (RCT) was to assess feasibility and acceptability of conducting community based sleep hygiene and yoga interventions, to be scaled and tested in a future, larger RCT.|Mean Difference (Net)|-2.02||||0.932|TWO_SIDED|95.0|-46.35|50.39|||t-test, 2 sided|Due to main findings, analysis to explore potential mediators of effect were not pursued, despite original plan to explore explanatory variables.||Null hypothesis: There is no difference in change in sleep duration between the two intervention arms.||50.39|-46.35|0.932
73977845|NCT03345979|147501720|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
74089313|NCT02697773|147731612|SUPERIORITY||Odds Ratio (OR)|1.56||||0.1351|TWO_SIDED|95.0|0.87|2.79|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|0.87|0.1351
73870830|NCT01200368|147285892|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.86|1.22||||||Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.22|0.86|
73870831|NCT01200368|147285892|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25||||||Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.25|0.87|
73949664|NCT01751113|147433272|SUPERIORITY_OR_OTHER||AUC ratio|1.288|||<|0.001|TWO_SIDED|95.0|1.224|1.355|||Mixed Models Analysis|||||1.355|1.224|<0.001
73949665|NCT01751113|147433273|SUPERIORITY_OR_OTHER||AUC ratio|0.856|||<|0.001|TWO_SIDED|95.0|0.812|0.902|||Mixed Models Analysis|||||0.902|0.812|<0.001
73949666|NCT01751113|147433273|SUPERIORITY_OR_OTHER||AUC ratio|0.774|||<|0.001|TWO_SIDED|95.0|0.735|0.816|||Mixed Models Analysis|||||0.816|0.735|<0.001
73949667|NCT01751113|147433274|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.181|||<|0.001|TWO_SIDED|95.0|1.104|1.263|||Mixed Models Analysis||Statistical data for 30 minutes|||1.263|1.104|<0.001
73949668|NCT01751113|147433274|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.303|||<|0.001|TWO_SIDED|95.0|1.219|1.393|||Mixed Models Analysis||Statistical data for 30 minutes|||1.393|1.219|<0.001
73949669|NCT01751113|147433274|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.175|||<|0.001|TWO_SIDED|95.0|1.099|1.257|||Mixed Models Analysis||Statistical data for 75 minutes|||1.257|1.099|<0.001
73949670|NCT01751113|147433274|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.34|||<|0.001|TWO_SIDED|95.0|1.253|1.432|||Mixed Models Analysis||Statistical data for 75 minutes|||1.432|1.253|<0.001
73949671|NCT01751113|147433274|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.151|||<|0.001|TWO_SIDED|95.0|1.076|1.231|||Mixed Models Analysis||Statistical data for 120 minutes|||1.231|1.076|<0.001
73949672|NCT01751113|147433274|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.301|||<|0.001|TWO_SIDED|95.0|1.217|1.391|||Mixed Models Analysis||Statistical data for 120 minutes|||1.391|1.217|<0.001
73949673|NCT01751113|147433274|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.141|||<|0.001|TWO_SIDED|95.0|1.067|1.22|||Mixed Models Analysis||Statistical data for 240 minutes|||1.220|1.067|<0.001
73949674|NCT01751113|147433274|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.239|||<|0.001|TWO_SIDED|95.0|1.159|1.325|||Mixed Models Analysis||Statistical data for 240 minutes|||1.325|1.159|<0.001
73949675|NCT01751113|147433275|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.846|||<|0.001|TWO_SIDED|95.0|0.792|0.905|||Mixed Models Analysis||Statistical data for 30 minutes|||0.905|0.792|<0.001
73949676|NCT01751113|147433275|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.767|||<|0.001|TWO_SIDED|95.0|0.717|0.819|||Mixed Models Analysis||Statistical data for 30 minutes|||0.819|0.717|<0.001
73949677|NCT01751113|147433275|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.795|0.909|||Mixed Models Analysis||Statistical data for 75 minutes|||0.909|0.795|<0.001
73949678|NCT01751113|147433275|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.746|||<|0.001|TWO_SIDED|95.0|0.698|0.798|||Mixed Models Analysis||Statistical data for 75 minutes|||0.798|0.698|<0.001
73949679|NCT01751113|147433275|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.868|||<|0.001|TWO_SIDED|95.0|0.812|0.928|||Mixed Models Analysis||Statistical data for 120 minutes|||0.928|0.812|<0.001
73949680|NCT01751113|147433275|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.769|||<|0.001|TWO_SIDED|95.0|0.719|0.822|||Mixed Models Analysis||Statistical data for 120 minutes|||0.822|0.719|<0.001
73949681|NCT01751113|147433275|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.877|||<|0.001|TWO_SIDED|95.0|0.82|0.938|||Mixed Models Analysis||Statistical data for 240 minutes|||0.938|0.820|<0.001
73949682|NCT01751113|147433275|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.809|||<|0.001|TWO_SIDED|95.0|0.757|0.865|||Mixed Models Analysis||Statistical data for 240 minutes|||0.865|0.757|<0.001
73949683|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.157|||<|0.001|TWO_SIDED|95.0|0.116|0.198|||Mixed Models Analysis||Statistical data for FEV1|||0.198|0.116|<0.001
73949684|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.118|||<|0.001|TWO_SIDED|95.0|0.077|0.159|||Mixed Models Analysis||Statistical data for FEV1|||0.159|0.077|<0.001
73949685|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.082||||0.002|TWO_SIDED|95.0|0.031|0.133|||Mixed Models Analysis||Statistical data for FVC|||0.133|0.031|0.002
73949686|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.135|||<|0.001|TWO_SIDED|95.0|0.084|0.186|||Mixed Models Analysis||Statistical data for FVC|||0.186|0.084|<0.001
73949687|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of IC|0.054||||0.035|TWO_SIDED|95.0|0.004|0.104|||Mixed Models Analysis||Statistical data for IC|||0.104|0.004|0.035
73949688|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of IC|0.064||||0.011|TWO_SIDED|95.0|0.015|0.114|||Mixed Models Analysis||Statistical data for IC|||0.114|0.015|0.011
73949689|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.107||||0.009|TWO_SIDED|95.0|-0.187|-0.028|||Mixed Models Analysis||Statistical data for RV|||-0.028|-0.187|0.009
73949690|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.102||||0.012|TWO_SIDED|95.0|-0.18|-0.023|||Mixed Models Analysis||Statistical data for RV|||-0.023|-0.180|0.012
73949691|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.013||||0.632|TWO_SIDED|95.0|-0.066|0.04|||Mixed Models Analysis||Statistical data for TLC|||0.040|-0.066|0.632
73977846|NCT03345979|147501720|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
73977847|NCT00487240|147501727|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority limit of 0.4% using the upper limit of a two-sided test at a significance level of 0.05 with 90% power assuming a 1.1 Standard Deviations (SD)|Mean Difference (Net)|-0.1||||0.332||95.0|-0.29|0.1|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|Hypothesis: basal analog insulin lispro protamine suspension (ILPS), is inferior to basal analog insulin detemir, as measured by change in HbA1c from baseline to endpoint.||0.10|-0.29|0.332
74009138|NCT02101515|147569022|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.06|13.92||||||||13.92|0.06|
73949692|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.014||||0.596|TWO_SIDED|95.0|-0.067|0.038|||Mixed Models Analysis||Statistical data for TLC|||0.038|-0.067|0.596
73949693|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.065||||0.028|TWO_SIDED|95.0|-0.123|-0.007|||Mixed Models Analysis||Statistical data for TGV|||-0.007|-0.123|0.028
73949694|NCT01751113|147433276|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.075||||0.01|TWO_SIDED|95.0|-0.133|-0.018|||Mixed Models Analysis||Statistical data for TGV|||-0.018|-0.133|0.010
73977848|NCT00487240|147501728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.718||95.0|-0.22|0.15||P-value for 8 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference=Insulin Lispro Protamine Suspension minus Detemir.|||0.15|-0.22|0.718
73977849|NCT00487240|147501728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.187||95.0|-0.34|0.07||P-value for 16 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.07|-0.34|0.187
73977850|NCT00487240|147501728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.704||95.0|-0.25|0.17||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.17|-0.25|0.704
73977851|NCT00487240|147501728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.599||95.0|-0.27|0.15||P-value for 32 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.15|-0.27|0.599
73977852|NCT00487240|147501729|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for With HbA1c ≤7.0%.|Fisher Exact|||||||1.000
73977853|NCT00487240|147501729|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for With HbA1c \<7.0%|Fisher Exact|||||||1.000
73977854|NCT00487240|147501729|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value for With HbA1c ≤6.5%|Fisher Exact|||||||0.722
73977855|NCT00487240|147501729|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||P-value for With HbA1c \<6.5%|Fisher Exact|||||||0.699
73977856|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.259||95.0||||P-value for Daily Mean 7-Point SMBG.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.259
73949695|NCT01751113|147433277|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.032|||<|0.001|TWO_SIDED|95.0|0.023|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.041|0.023|<0.001
73949696|NCT01751113|147433277|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.017|||<|0.001|TWO_SIDED|95.0|0.008|0.026|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.026|0.008|<0.001
73949697|NCT01751113|147433278|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.835|||<|0.001|TWO_SIDED|95.0|0.77|0.905|||Mixed Models Analysis|||||0.905|0.770|<0.001
73949698|NCT01751113|147433278|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.803|||<|0.001|TWO_SIDED|95.0|0.741|0.869|||Mixed Models Analysis|||||0.869|0.741|<0.001
73949699|NCT01751113|147433279|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.108|1.301|||Mixed Models Analysis|||||1.301|1.108|<0.001
73977857|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||P-value for Daily Mean Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.468
73977858|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.395||95.0||||P-value for Daily Mean Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.395
73977859|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value for Daily Mean Morning and Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.414
73977860|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Actual Morning Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.275
73977861|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.611||95.0||||P-value for Actual Morning Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.611
73977862|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.763||95.0||||P-value for Actual Midday Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.763
73977863|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.977||95.0||||P-value for Actual Midday Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.977
73977864|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.586||95.0||||P-value for Actual Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.586
73977865|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for Actual Evening Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.093
73977866|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value for Actual 0300 Hours|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.516
73977867|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||P-value for Actual Morning SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.576
73977868|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.876||95.0||||P-value for Midday SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.876
73977869|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value for Evening SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.261
73977870|NCT00487240|147501730|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-value for Daily Mean SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.567
73977871|NCT00487240|147501731|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 0.8 mmol/L was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.36||||||95.0|-0.03|0.75|||||Least Squares Mean difference = Insulin Lispro Protamine Suspension - Detemir|If the primary analysis achieves statistical significance at a 0.05 level (that is, the null hypothesis for the primary analysis \[primary outcome measure\] is rejected), then the first secondary hypothesis (glycemic variability) is tested at an error rate of 0.05.||0.75|-0.03|
73977872|NCT00487240|147501731|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value for M-Value|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.132
73977873|NCT00487240|147501731|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value for MODD|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.179
73977874|NCT00487240|147501732|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for Endpoint Hypoglycemic Episodes|Fisher Exact|||||||0.737
73977875|NCT00487240|147501732|SUPERIORITY_OR_OTHER|||||||0.724||95.0||||P-value for Overall Hypoglycemic Episodes|Fisher Exact|||||||0.724
74089314|NCT02697773|147731612|SUPERIORITY|The two comparisons for 'Participants with ≥50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|2.17|||<|0.0001|TWO_SIDED|95.0|1.48|3.16|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.16|1.48|<.0001
74089315|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0001|TWO_SIDED|95.0|1.45|3.11|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.11|1.45|0.0001
73949700|NCT01751113|147433279|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.249|||<|0.001|TWO_SIDED|95.0|1.153|1.352|||Mixed Models Analysis|||||1.352|1.153|<0.001
73949701|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.161|||<|0.001|TWO_SIDED|95.0|0.086|0.236|||Mixed Models Analysis||Statistical data for FEV1|||0.236|0.086|<0.001
73949702|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.103||||0.008|TWO_SIDED|95.0|0.028|0.178|||Mixed Models Analysis||Statistical data for FEV1|||0.178|0.028|0.008
73949703|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.104||||0.051|TWO_SIDED|95.0|0.0|0.209|||Mixed Models Analysis||Statistical data for FVC|||0.209|0.000|0.051
73949704|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.148||||0.006|TWO_SIDED|95.0|0.043|0.253|||Mixed Models Analysis||Statistical data for FVC|||0.253|0.043|0.006
73949705|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of IC|-0.008||||0.89|TWO_SIDED|95.0|-0.12|0.104|||Mixed Models Analysis||Statistical data for IC|||0.104|-0.120|0.890
73949706|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of IC|-0.008||||0.89|TWO_SIDED|95.0|-0.118|0.103|||Mixed Models Analysis||Statistical data for IC|||0.103|-0.118|0.890
73949707|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.229|||<|0.001|TWO_SIDED|95.0|-0.355|-0.103|||Mixed Models Analysis||Statistical data for RV|||-0.103|-0.355|<0.001
73949708|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.189||||0.003|TWO_SIDED|95.0|-0.314|-0.064|||Mixed Models Analysis||Statistical data for RV|||-0.064|-0.314|0.003
73949709|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.101||||0.055|TWO_SIDED|95.0|-0.204|0.002|||Mixed Models Analysis||Statistical data for TLC|||0.002|-0.204|0.055
73949710|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.105||||0.044|TWO_SIDED|95.0|-0.206|-0.003|||Mixed Models Analysis||Statistical data for TLC|||-0.003|-0.206|0.044
73949711|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.092||||0.085|TWO_SIDED|95.0|-0.197|0.013|||Mixed Models Analysis||Statistical data for TGV|||0.013|-0.197|0.085
73949712|NCT01751113|147433280|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.091||||0.083|TWO_SIDED|95.0|-0.195|0.012|||Mixed Models Analysis||Statistical data for TGV|||0.012|-0.195|0.083
73977876|NCT00487240|147501732|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.157
73977877|NCT00487240|147501732|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||P-value for Overall Nocturnal Episodes|Fisher Exact|||||||0.287
73977878|NCT00487240|147501732|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.664
73949713|NCT01751113|147433281|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.027|||<|0.001|TWO_SIDED|95.0|0.014|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.041|0.014|<0.001
73949714|NCT01751113|147433281|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.008||||0.223|TWO_SIDED|95.0|-0.005|0.021|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.021|-0.005|0.223
73949715|NCT03745794|147433287|OTHER|||||||0.17|||||||Chi-squared|||||||0.17
73949716|NCT00981825|147433300|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73949717|NCT02743793|147433301|OTHER|No test was performed.|Kaplan-Meier survival estimate|64.0|||||TWO_SIDED|95.0|21.3|87.9|||||Percent of participants that remained tolerant during study participation.|||87.9|21.3|
73949718|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.27||||0.087|TWO_SIDED|95.0|-0.58|0.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline A1C.||||0.04|-0.58|0.087
73949719|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.84|||<|0.001|TWO_SIDED|95.0|-1.15|-0.52||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.52|-1.15|<0.001
73949720|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.39||||0.014|TWO_SIDED|95.0|-0.69|-0.08||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.08|-0.69|0.014
73949721|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.68|||<|0.001|TWO_SIDED|95.0|-0.99|-0.37||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.37|-0.99|<0.001
73949722|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.24|||<|0.001|TWO_SIDED|95.0|-1.55|-0.93||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.93|-1.55|<0.001
73949723|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.97|||<|0.001|TWO_SIDED|95.0|-1.28|-0.66||Pairwise comparison, metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.66|-1.28|<0.001
73949724|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.08|||<|0.001|TWO_SIDED|95.0|-1.39|-0.78||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.78|-1.39|<0.001
73949725|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.7|||<|0.001|TWO_SIDED|95.0|-1.01|-0.39||Pairwise comparison, metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.39|-1.01|<0.001
73949726|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.4||||0.011|TWO_SIDED|95.0|-0.71|-0.09||Pairwise comparison, sitagliptin 100 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.09|-0.71|0.011
73949727|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.36||||0.008|TWO_SIDED|95.0|-0.62|-0.09||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.09|-0.62|0.008
73949728|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.87|||<|0.001|TWO_SIDED|95.0|-1.13|-0.6||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.60|-1.13|<0.001
73949729|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.36||||0.007|TWO_SIDED|95.0|-0.63|-0.1||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.10|-0.63|0.007
73949730|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.61|||<|0.001|TWO_SIDED|95.0|-0.88|-0.35||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.35|-0.88|<0.001
73949731|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.25|||<|0.001|TWO_SIDED|95.0|-1.52|-0.99||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.99|-1.52|<0.001
73949732|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.9|||<|0.001|TWO_SIDED|95.0|-1.16|-0.63||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.63|-1.16|<0.001
73949733|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.0|||<|0.001|TWO_SIDED|95.0|-1.26|-0.74||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.74|-1.26|<0.001
73977879|NCT00487240|147501732|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.730
73977880|NCT00487240|147501732|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for Endpoint Severe Hypoglycemic Episodes|Fisher Exact|||||||0.053
73977881|NCT00487240|147501732|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-value for Overall Severe Hypoglycemic Episodes|Fisher Exact|||||||0.081
73977882|NCT00487240|147501733|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value for Endpoint Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.280
73977883|NCT00487240|147501733|SUPERIORITY_OR_OTHER|||||||0.193||95.0||||P-value for Overall Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.193
73977884|NCT00487240|147501733|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.042
73977885|NCT00487240|147501733|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Overall Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.001
74009139|NCT02101515|147569024|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.41|||||TWO_SIDED|95.0|0.68|42.9||||||||42.90|0.68|
73949734|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.64|||<|0.001|TWO_SIDED|95.0|-0.9|-0.37||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.37|-0.90|<0.001
73949735|NCT01076088|147433332|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.39||||0.004|TWO_SIDED|95.0|-0.65|-0.12||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.12|-0.65|0.004
73949736|NCT01076088|147433333|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-18.52||||0.017|TWO_SIDED|95.0|-33.75|-3.29||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-3.29|-33.75|0.017
73949737|NCT01076088|147433333|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-61.34|||<|0.001|TWO_SIDED|95.0|-76.61|-46.07||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-46.07|-76.61|<0.001
73949738|NCT01076088|147433333|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-31.38|||<|0.001|TWO_SIDED|95.0|-46.49|-16.28||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-16.28|-46.49|<0.001
73949739|NCT01076088|147433333|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-48.94|||<|0.001|TWO_SIDED|95.0|-64.21|-33.67||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-33.67|-64.21|<0.001
73949740|NCT01076088|147433333|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-87.57|||<|0.001|TWO_SIDED|95.0|-102.87|-72.27||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-72.27|-102.87|<0.001
73949741|NCT01076088|147433333|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-69.05|||<|0.001|TWO_SIDED|95.0|-84.41|-53.7||Pairwise comparison, metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-53.70|-84.41|<0.001
73949742|NCT01076088|147433333|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-75.17|||<|0.001|TWO_SIDED|95.0|-90.47|-59.87||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-59.87|-90.47|<0.001
73949743|NCT01076088|147433333|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-43.79|||<|0.001|TWO_SIDED|95.0|-58.99|-28.58||Pairwise comparison, metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-28.58|-58.99|<0.001
73949744|NCT01076088|147433333|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-26.23|||<|0.001|TWO_SIDED|95.0|-41.62|-10.84||Pairwise comparison, sitagliptin 100 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-10.84|-41.62|<0.001
73977886|NCT00487240|147501733|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.579
73977887|NCT00487240|147501733|SUPERIORITY_OR_OTHER|||||||0.531||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.531
73977888|NCT00487240|147501733|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Endpoint Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.017
73977889|NCT00487240|147501733|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Overall Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.038
73949745|NCT01076088|147433334|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.11||||0.069|TWO_SIDED|95.0|-16.86|0.64||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||0.64|-16.86|0.069
73977890|NCT00487240|147501735|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 1.5 kg was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.97||||0.003||95.0|0.34|1.6||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|If the first secondary null hypothesis (glycemic variability) is rejected, then the second secondary hypothesis (weight change) is tested at an error rate of 0.05.||1.60|0.34|0.003
73977891|NCT00487240|147501736|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.023
73977892|NCT00487240|147501736|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.004
73977893|NCT00487240|147501736|SUPERIORITY_OR_OTHER|||||||0.282||95.0||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.282
73977894|NCT00487240|147501737|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.82
73977895|NCT00487240|147501737|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.19
73977896|NCT00487240|147501737|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.416
74009140|NCT02101515|147569026|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.46|1.54||||||||1.54|0.46|
73977897|NCT00670488|147501824|OTHER||AUC0-48hr GMR|3.26||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr Geometric Mean Ratio (GMR) was calculated as follows: Last Day (Day 27) AUC 0-48hr Geometric Mean (GM) ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
73977898|NCT00670488|147501824|OTHER||AUC 0-48hr GMR|3.18||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr GMR was calculated as follows: Last Day (Day 27) AUC 0-48hr GM ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
73977899|NCT00670488|147501825|OTHER||Cmax GMR|2.59||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
73977900|NCT00670488|147501825|OTHER||Cmax GMR|2.67||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
73977901|NCT00670488|147501826|OTHER||C48hr GMR|4.33||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
73977902|NCT00670488|147501826|OTHER||C48hr GMR|3.58||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
73977903|NCT00670488|147501829|OTHER||AUC0-168hr GMR|1.91||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.||||
73977904|NCT00670488|147501829|OTHER||AUC 0-168hr GMR|1.54||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.||||
73977905|NCT00670488|147501830|OTHER||Cmax GMR|1.95||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.||||
73977906|NCT00670488|147501830|OTHER||Cmax GMR|1.33||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.||||
73977907|NCT00670488|147501831|OTHER||C48hr GMR|1.61||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
73977908|NCT00670488|147501831|OTHER||C48hr GMR|1.86||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
73977909|NCT00670488|147501831|OTHER||C48hr GMR|1.49||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
73977910|NCT00670488|147501834|OTHER||GMR|0.133|||||TWO_SIDED|95.0|0.051|0.347||||||"pAkt Geometric Mean Ratio (GMR)~= Day 15 Geometric Mean (GM) ÷ Baseline GM"||0.347|0.051|
73977911|NCT04218864|147501866|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Linear Mixed regression models (LMM) have been used to identify any difference between the intervention and the control groups over time with regards to the continuous outcomes. Group (intervention vs. control), a 5-category time (baseline, 6 week, 3 month, 6 month, 12 month) and group-by-time interaction are covariates in the model. A random subject intercept is used to account for clustering within subject.||||>0.05
73977912|NCT04218864|147501867|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for the primary outcome.||||>0.05
73977913|NCT04218864|147501868|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for the primary outcome.||||>0.05
73977914|NCT04218864|147501869|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for primary outcome.||||>0.05
73977915|NCT04218864|147501870|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical Analysis strategy is identical to that for primary outcome measure.||||>0.05
73977916|NCT02831816|147501871|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 cfu/cm2 less than the active control.|Median Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.221|0.18||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.180|-0.221|
73977917|NCT02831816|147501871|SUPERIORITY||Median Difference (Final Values)|2.45|||||TWO_SIDED|95.0|2.15|2.76||||||Groin 10 minutes Average Treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.76|2.15|
73977918|NCT02831816|147501872|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 cfu/cm2 less than the active control.|Mean Difference (Final Values)|-0.0435|||||TWO_SIDED|95.0|-0.2085|0.1215||||||Abdomen 10 minutes average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.1215|-0.2085|
74009141|NCT02101515|147569027|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.39|1.49||||||||1.49|0.39|
74009142|NCT02101515|147569029|SUPERIORITY_OR_OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
74009143|NCT02101515|147569033|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3|||||TWO_SIDED|95.0|0.03|2.77||||||||2.77|0.03|
74009144|NCT01010633|147569046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.3|||<|0.001|TWO_SIDED|95.0|5.7|22.9|||Chi-squared|||||22.9|5.7|<0.001
73977919|NCT02831816|147501872|SUPERIORITY||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.7|2.25||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.25|1.70|
73949746|NCT01076088|147433334|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-25.88|||<|0.001|TWO_SIDED|95.0|-34.72|-17.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-17.04|-34.72|<0.001
73949747|NCT01076088|147433334|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.72||||0.198|TWO_SIDED|95.0|-14.44|3.0||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||3.00|-14.44|0.198
73949748|NCT01076088|147433334|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-17.53|||<|0.001|TWO_SIDED|95.0|-26.33|-8.72||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-8.72|-26.33|<0.001
73949749|NCT01076088|147433334|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-35.81|||<|0.001|TWO_SIDED|95.0|-44.56|-27.06||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-27.06|-44.56|<0.001
73949750|NCT01076088|147433334|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-27.7|||<|0.001|TWO_SIDED|95.0|-36.4|-19.0||Pairwise comparison, metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-19.00|-36.40|<0.001
73949751|NCT01076088|147433334|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-27.45|||<|0.001|TWO_SIDED|95.0|-36.18|-18.73||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-18.73|-36.18|<0.001
73949752|NCT01076088|147433334|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-21.73|||<|0.001|TWO_SIDED|95.0|-30.42|-13.04||Pairwise comparison, metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-13.04|-30.42|<0.001
73949753|NCT01076088|147433334|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.93||||0.027|TWO_SIDED|95.0|-18.72|-1.14||Pairwise comparison, sitagliptin 100 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-1.14|-18.72|0.027
73949754|NCT01544491|147433343|NON_INFERIORITY|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|5.25||0.9712|TWO_SIDED|80.0|-6.6|6.8|||Log Rank|||at 12 months||6.8|-6.6|0.9712
73949755|NCT01544491|147433343|NON_INFERIORITY|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|5.84||0.9634|TWO_SIDED|80.0|-7.3|7.7|||Log Rank|||36 months||7.7|-7.3|0.9634
73949756|NCT01544491|147433344|NON_INFERIORITY|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|5.26||0.3455|TWO_SIDED|80.0|-1.8|11.8|||t-test, 2 sided|||at 12 months||11.8|-1.8|0.3455
73949757|NCT01544491|147433344|NON_INFERIORITY|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|4.95||0.8642|TWO_SIDED|80.0|-5.5|7.2|||t-test, 2 sided|||36 months||7.2|-5.5|0.8642
73949758|NCT02733042|147433378|OTHER|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm B, ibrutinib 420 mg was confirmed as the RP2D for CLL/SLL participants and ibrutinib 560 mg was confirmed as the RP2D for MCL participants.|||
73949759|NCT02733042|147433378|OTHER|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm C the RP2D was confirmed as rituximab 375 mg/m² + bendamustine 70 mg/m².|||
73949760|NCT01088529|147433406|SUPERIORITY_OR_OTHER||Relative risk|1.432||||0.2148|TWO_SIDED|90.0|0.859|2.386|||Chi-squared|||||2.386|0.859|0.2148
73949761|NCT01088529|147433407|SUPERIORITY_OR_OTHER||Relative risk|0.477||||0.1796|TWO_SIDED|90.0|0.205|1.109|||Fisher Exact|||||1.109|0.205|0.1796
73949762|NCT01088529|147433408|SUPERIORITY_OR_OTHER||Relative risk|6.523|||<|0.0001|TWO_SIDED|90.0|2.701|15.753|||Chi-squared|||||15.753|2.701|<0.0001
73949763|NCT02341144|147433416|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
73949764|NCT02341144|147433417|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
73949765|NCT02341144|147433418|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
73949766|NCT02341144|147433419|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
73949767|NCT02341144|147433420|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
73949768|NCT00337662|147433422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Between-group p-values for each baseline to post-baseline visit were the same, p\<0.001.|Mixed Effects Model Repeated Measures|||||||<0.001
73949769|NCT00337662|147433423|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Change from Week 2 to Week 3 p-value|Mixed-Effects Model Repeated-Measures|||||||0.266
73949770|NCT00337662|147433423|SUPERIORITY_OR_OTHER|||||||0.884||95.0||||Change from Week 2 to Week 4 p-value|Mixed-Effects Model Repeated-Measures|||||||0.884
73949771|NCT00337662|147433423|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||Change from Week 2 to Week 6 p-value|Mixed-Effects Model Repeated-Measures|||||||0.151
73949772|NCT00337662|147433423|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Change from Week 2 to Week 8 p-value|Mixed-Effects Model Repeated-Measures|||||||0.216
73977920|NCT00145470|147501888|SUPERIORITY|||||||0.0257||||||P-value based on the difference in the least squares (LS) means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0257
73977921|NCT00145470|147501891|SUPERIORITY|||||||0.021||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 42||||0.0210
73977922|NCT00145470|147501892|SUPERIORITY|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0073
73977923|NCT00145470|147501893|SUPERIORITY|||||||0.3928|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 3||||0.3928
73977924|NCT00145470|147501893|SUPERIORITY|||||||0.7923|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 7||||0.7923
73977925|NCT00145470|147501893|SUPERIORITY|||||||0.0701|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 14||||0.0701
73977926|NCT00145470|147501893|SUPERIORITY|||||||0.1634|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 21||||0.1634
73977927|NCT00145470|147501893|SUPERIORITY|||||||0.037|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 42||||0.0370
73977928|NCT00145470|147501893|SUPERIORITY|||||||0.0488|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 63||||0.0488
74089316|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.59|3.4|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.40|1.59|<.0001
74089317|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0312|TWO_SIDED|95.0|1.04|2.39|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.39|1.04|0.0312
74089318|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0003|TWO_SIDED|95.0|1.4|3.19|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.19|1.40|0.0003
73977929|NCT00145470|147501893|SUPERIORITY|||||||0.0152|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 84||||0.0152
73949773|NCT00337662|147433423|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Change from Week 2 to Week 12 p-value|Mixed-Effects Model Repeated-Measures|||||||0.020
73949774|NCT00337662|147433424|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73949775|NCT00337662|147433425|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||Fisher Exact|||||||0.604
73949776|NCT00337662|147433426|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73949777|NCT00337662|147433427|SUPERIORITY_OR_OTHER|||||||0.745||95.0|||||Fisher Exact|||||||0.745
73949778|NCT00337662|147433428|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Fisher Exact|||||||0.474
73949779|NCT00337662|147433429|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.034
73977930|NCT00145470|147501894|SUPERIORITY|||||||0.3709|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 3||||0.3709
73977931|NCT00145470|147501894|SUPERIORITY|||||||0.8837|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 7||||0.8837
73977932|NCT00145470|147501894|SUPERIORITY|||||||0.1153|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 14||||0.1153
73977933|NCT00145470|147501894|SUPERIORITY|||||||0.0158|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 21||||0.0158
73977934|NCT00145470|147501894|SUPERIORITY|||||||0.0143|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 42||||0.0143
73977935|NCT00145470|147501894|SUPERIORITY|||||||0.0196|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 63||||0.0196
73977936|NCT00145470|147501894|SUPERIORITY|||||||0.0148|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 84||||0.0148
73977937|NCT00145470|147501895|SUPERIORITY|||||||0.0046||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0046
73977938|NCT00145470|147501896|SUPERIORITY|||||||0.0006||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0006
73977939|NCT00145470|147501897|SUPERIORITY|||||||0.3497||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.3497
73977940|NCT00145470|147501898|SUPERIORITY|||||||0.7753||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.7753
73977941|NCT00145470|147501899|SUPERIORITY|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0073
73977942|NCT00145470|147501900|SUPERIORITY|||||||0.0102||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0102
73949780|NCT00337662|147433429|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.125
73949781|NCT00337662|147433430|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||All comparisons between EO-RIS and NEO-RIS and between NEO-RIS and NEO-OLZ had p-values greater than 0.05.|Fisher Exact|||||||>0.05
73977943|NCT00145470|147501901|SUPERIORITY|||||||0.3684||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.3684
73977944|NCT00145470|147501902|SUPERIORITY|||||||0.937||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.9370
73977945|NCT00145470|147501903|SUPERIORITY|||||||0.2492||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.2492
73977946|NCT00145470|147501904|SUPERIORITY|||||||0.4683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.4683
73977947|NCT00145470|147501905|SUPERIORITY|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.5683
73977948|NCT00145470|147501906|SUPERIORITY|||||||0.9693||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.9693
73977949|NCT00145470|147501907|SUPERIORITY|||||||0.6136||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.6136
73977950|NCT00145470|147501908|SUPERIORITY|||||||0.1586||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.1586
73977951|NCT00145470|147501909|SUPERIORITY|||||||0.055||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 21||||0.0550
73977952|NCT00145470|147501909|SUPERIORITY|||||||0.7469||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 21||||0.7469
73949782|NCT00337662|147433431|SUPERIORITY_OR_OTHER|||||||0.355||95.0|||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.||||||0.355
73977953|NCT00145470|147501909|SUPERIORITY|||||||0.3253||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 21||||0.3253
73949783|NCT00337662|147433431|SUPERIORITY_OR_OTHER|||||||0.244||95.0|||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.||||||0.244
73949784|NCT00337662|147433432|SUPERIORITY_OR_OTHER|||||||0.998||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.998
73977954|NCT00145470|147501909|SUPERIORITY|||||||0.3885||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 21||||0.3885
73977955|NCT00145470|147501909|SUPERIORITY|||||||0.5975||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 21||||0.5975
73977956|NCT00145470|147501909|SUPERIORITY|||||||0.069||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 21||||0.0690
73977957|NCT00145470|147501909|SUPERIORITY|||||||0.797||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 21||||0.7970
73977958|NCT00145470|147501909|SUPERIORITY|||||||0.8339||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 21||||0.8339
73977959|NCT00145470|147501909|SUPERIORITY|||||||0.2101||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 21||||0.2101
73977960|NCT00145470|147501910|SUPERIORITY|||||||0.6914||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 84||||0.6914
73977961|NCT00145470|147501910|SUPERIORITY|||||||0.8805||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 84||||0.8805
73977962|NCT00145470|147501910|SUPERIORITY|||||||0.4878||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 84||||0.4878
73977963|NCT00145470|147501910|SUPERIORITY|||||||0.8051||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 84||||0.8051
73949785|NCT00337662|147433432|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.505
73949786|NCT00337662|147433433|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.266
73949787|NCT00337662|147433433|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.015
73949788|NCT00337662|147433434|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.140
73949789|NCT00337662|147433434|SUPERIORITY_OR_OTHER|||||||0.181||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.181
73949790|NCT00337662|147433435|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.254
73977964|NCT00145470|147501910|SUPERIORITY|||||||0.1925||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 84||||0.1925
73977965|NCT00145470|147501910|SUPERIORITY|||||||0.0514||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 84||||0.0514
73977966|NCT00145470|147501910|SUPERIORITY|||||||0.9898||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 84||||0.9898
73977967|NCT00145470|147501910|SUPERIORITY|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 84||||0.5683
73949791|NCT00337662|147433435|SUPERIORITY_OR_OTHER|||||||0.299||95.0|||||ANOVA|P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.||||||0.299
73949792|NCT00337662|147433436|SUPERIORITY_OR_OTHER|||||||0.291||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.291
73949793|NCT00337662|147433436|SUPERIORITY_OR_OTHER|||||||0.259||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.259
73949794|NCT00337662|147433437|SUPERIORITY_OR_OTHER|||||||0.209||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.209
73949795|NCT00337662|147433437|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.411
73949796|NCT00337662|147433438|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.544
73949797|NCT00337662|147433438|SUPERIORITY_OR_OTHER|||||||0.386||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.386
73949798|NCT00337662|147433439|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.026
73949799|NCT00337662|147433439|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.143
73949800|NCT03691948|147433444|SUPERIORITY|||||||0.531|||||||ANOVA|||||||.531
73949801|NCT03691948|147433445|SUPERIORITY|||||||0.076|||||||ANOVA|||||||0.076
73949802|NCT00405704|147433480|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
73949803|NCT00405704|147433481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.55
73949804|NCT00405704|147433482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.37
73949805|NCT00405704|147433483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.94
73949806|NCT00405704|147433484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||Log Rank|||||||0.04
73949807|NCT00405704|147433485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.065|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.065
73977968|NCT00145470|147501910|SUPERIORITY|||||||0.8907||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 84||||0.8907
73977969|NCT00145470|147501911|SUPERIORITY|||||||0.0613|||||||Log Rank|||||||0.0613
73977970|NCT00145470|147501912|SUPERIORITY|||||||0.7493||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.7493
73977971|NCT00145470|147501913|SUPERIORITY|||||||0.4884||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.4884
73977972|NCT00145470|147501914|SUPERIORITY|||||||0.128||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 21||||0.1280
73977973|NCT00145470|147501914|SUPERIORITY|||||||0.0215||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 21||||0.0215
73977974|NCT00145470|147501915|SUPERIORITY|||||||0.1331||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 84||||0.1331
73977975|NCT00145470|147501915|SUPERIORITY|||||||0.2024||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 84||||0.2024
73949808|NCT00405704|147433486|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73949809|NCT00405704|147433487|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73949810|NCT03012061|147433488|SUPERIORITY||Mean Difference (Net)|0.1758|STANDARD_ERROR_OF_MEAN|0.0426|<|0.001|TWO_SIDED|95.0|0.092|0.2595|||Mixed-model repeated measures (MMRM)||UMEC 31.25 mcg versus placebo|||0.2595|0.0920|<0.001
73949811|NCT03012061|147433488|SUPERIORITY||Mean Difference (Net)|0.1841|STANDARD_ERROR_OF_MEAN|0.0424|<|0.001|TWO_SIDED|95.0|0.1008|0.2675|||MMRM||UMEC 62.5 mcg versus placebo|||0.2675|0.1008|<0.001
73949812|NCT03012061|147433489|SUPERIORITY||Mean Difference (Net)|0.1895|STANDARD_ERROR_OF_MEAN|0.0455|<|0.001|TWO_SIDED|95.0|0.1|0.2789||Analysis of covariance (ANCOVA)|ANCOVA||UMEC 31.25 mcg vs Placebo|||0.2789|0.1000|<0.001
73949813|NCT03012061|147433489|SUPERIORITY||Mean Difference (Net)|0.1976|STANDARD_ERROR_OF_MEAN|0.0453|<|0.001|TWO_SIDED|95.0|0.1086|0.2866|||ANCOVA||UMEC 62.5 mcg vs Placebo|||0.2866|0.1086|<0.001
73949814|NCT03012061|147433492|SUPERIORITY||Median Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.0||0.083|TWO_SIDED|95.0|-0.2|3.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 4|||3.7|-0.2|0.083
73949815|NCT03012061|147433492|SUPERIORITY||Median Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.11||0.636|TWO_SIDED|95.0|-2.7|1.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 12|||1.7|-2.7|0.636
73949816|NCT03012061|147433492|SUPERIORITY||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.1||0.115|TWO_SIDED|95.0|-0.4|3.9|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 24|||3.9|-0.4|0.115
73949817|NCT03012061|147433492|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.99||0.336|TWO_SIDED|95.0|-1.0|2.9|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 4|||2.9|-1.0|0.336
73949818|NCT03012061|147433492|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.11||0.787|TWO_SIDED|95.0|-1.9|2.5|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 12|||2.5|-1.9|0.787
74032478|NCT04742907|147618153|SUPERIORITY||Odds Ratio (OR)|1.12||||0.693|TWO_SIDED|95.0|0.63|1.99||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.99|0.63|0.693
73949819|NCT03012061|147433492|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|1.1||0.625|TWO_SIDED|95.0|-1.6|2.7|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 24|||2.7|-1.6|0.625
73949820|NCT03012061|147433492|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.79||0.309|TWO_SIDED|95.0|-0.7|2.3|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 4|||2.3|-0.7|0.309
73949821|NCT03012061|147433492|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.82||0.521|TWO_SIDED|95.0|-2.1|1.1|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 12|||1.1|-2.1|0.521
73949822|NCT03012061|147433492|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.81||0.047|TWO_SIDED|95.0|0.0|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 24|||3.2|0.0|0.047
73949823|NCT03012061|147433492|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.78||0.779|TWO_SIDED|95.0|-1.3|1.8|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 4|||1.8|-1.3|0.779
73949824|NCT03012061|147433492|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.82||0.204|TWO_SIDED|95.0|-0.6|2.6|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 12|||2.6|-0.6|0.204
73949825|NCT03012061|147433492|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|0.81||0.066|TWO_SIDED|95.0|-0.1|3.1|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 24|||3.1|-0.1|0.066
73949826|NCT03012061|147433493|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|0.97||0.195|TWO_SIDED|95.0|-0.7|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, Week 4|||3.2|-0.7|0.195
73949827|NCT03012061|147433493|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.84||0.457|TWO_SIDED|95.0|-1.0|2.3|||MMRM||UMEC 31.25 mcg versus Placebo, Week 12|||2.3|-1.0|0.457
73949828|NCT03012061|147433493|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.07||0.3|TWO_SIDED|95.0|-1.0|3.2|||MMRM||UMEC 31.25 mcg versus Placebo, Week 24|||3.2|-1.0|0.300
73949829|NCT03012061|147433493|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|0.97||0.14|TWO_SIDED|95.0|-0.5|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 4|||3.3|-0.5|0.140
73949830|NCT03012061|147433493|SUPERIORITY||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|0.84||0.045|TWO_SIDED|95.0|0.0|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 12|||3.3|0.0|0.045
73949831|NCT03012061|147433493|SUPERIORITY||Mean Difference (Net)|3.4|STANDARD_ERROR_OF_MEAN|1.07||0.002|TWO_SIDED|95.0|1.3|5.5|||MMRM||UMEC 62.5 mcg versus Placebo, Week 24|||5.5|1.3|0.002
73949832|NCT02696902|147433494|SUPERIORITY||Relative risk reduction|-23.7||||0.491|TWO_SIDED|80.0|-83.8|16.8|||Poisson regression with robust variance|||||16.8|-83.8|0.491
73949833|NCT00383240|147433513|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949834|NCT00383240|147433513|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949835|NCT00383240|147433513|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949836|NCT00383240|147433513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.491||95.0||||P-Value for Endpoint|ANCOVA|||||||0.491
73949837|NCT00383240|147433513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0||||P-Value for Endpoint|ANCOVA|||||||0.055
73949838|NCT00383240|147433513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||P-Value for Endpoint|ANCOVA|||||||0.008
73949839|NCT00383240|147433514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0||||P-Value for Endpoint|ANCOVA|||||||0.174
73949840|NCT00383240|147433514|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949841|NCT00383240|147433514|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949842|NCT00383240|147433514|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949843|NCT00383240|147433514|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949844|NCT00383240|147433514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.521||95.0||||P-Value for Endpoint|ANCOVA|||||||0.521
73949845|NCT00383240|147433516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0||||P-Value for Endpoint|ANCOVA|||||||0.026
73949846|NCT00383240|147433516|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949847|NCT00383240|147433516|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949848|NCT00383240|147433516|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949849|NCT00383240|147433516|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949850|NCT00383240|147433516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738||95.0||||P-Value for Endpoint|ANCOVA|||||||0.738
73949851|NCT00383240|147433517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0||||P-Value for endpoint|ANCOVA|||||||0.063
73949852|NCT00383240|147433517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949853|NCT00383240|147433517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949854|NCT00383240|147433517|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
73949855|NCT00383240|147433517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||P-Value for Endpoint|ANCOVA|||||||0.003
73949856|NCT00383240|147433517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.601||95.0||||P-Value for Endpoint|ANCOVA|||||||0.601
73977976|NCT02609048|147501931|SUPERIORITY||Difference in LSM|-60.99|STANDARD_ERROR_OF_MEAN|5.814|<|0.0001|TWO_SIDED|95.0|-72.85|-49.13||Difference in mean,p-value, and CIs estimated by comparing Seladelpar level with placebo by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-49.13|-72.85|<0.0001
73977977|NCT02609048|147501931|SUPERIORITY||Difference in Least Squares Mean (LSM)|-51.37|STANDARD_ERROR_OF_MEAN|5.849|<|0.0001|TWO_SIDED|95.0|-63.3|-39.44||Difference in mean,p-value, and confidence intervals (CIs) estimated by comparing Seladelpar level with placebo by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-39.44|-63.30|<0.0001
73977978|NCT02609048|147501931|SUPERIORITY||Difference in Least Squares Mean (LSM)|-9.62|STANDARD_ERROR_OF_MEAN|5.963||0.1167|TWO_SIDED|95.0|-21.79|2.54||Difference in mean,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||2.54|-21.79|0.1167
73977979|NCT02609048|147501932|SUPERIORITY||||||<|0.0001||||||The p-values were calculated from Fisher's exact test comparing each Seladelpar group with Placebo separately.|Fisher Exact|||||||<0.0001
73949857|NCT02023879|147433520|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-56.4|||<|0.0001|TWO_SIDED|95.0|-62.9|-49.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q4W/up to 150 mg Q2W was compared to placebo group using an appropriate contrast statement.||-49.9|-62.9|<0.0001
73949858|NCT02023879|147433521|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.7|||<|0.0001|TWO_SIDED|95.0|-65.6|-53.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-53.8|-65.6|<0.0001
73949859|NCT02023879|147433522|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.9|||<|0.0001|TWO_SIDED|95.0|-51.8|-38.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-38.1|-51.8|<0.0001
73949860|NCT02023879|147433523|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-54.8|-41.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.9|-54.8|<0.0001
73949861|NCT02023879|147433524|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.5|||<|0.0001|TWO_SIDED|95.0|-61.1|-49.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.8|-61.1|<0.0001
73949862|NCT02023879|147433525|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.6|||<|0.0001|TWO_SIDED|95.0|-63.8|-53.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.4|-63.8|<0.0001
73949863|NCT02023879|147433526|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.4|||<|0.0001|TWO_SIDED|95.0|-52.4|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-40.4|-52.4|<0.0001
73949864|NCT02023879|147433527|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.6|||<|0.0001|TWO_SIDED|95.0|-54.3|-42.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.8|-54.3|<0.0001
73949865|NCT02023879|147433528|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|95.0|-54.9|-43.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.2|-54.9|<0.0001
73977980|NCT02609048|147501932|SUPERIORITY|||||||0.0036||||||The p-values were calculated from Fisher's exact test comparing each Seladelpar group with Placebo separately.|Fisher Exact|||||||0.0036
73977981|NCT02609048|147501932|SUPERIORITY|||||||0.1045||||||The p-values were calculated from Fisher's exact test comparing Seladelpar 200mg versus 50 mg.|Fisher Exact|||||||0.1045
73977982|NCT02609048|147501933|SUPERIORITY||Difference in LSM|234.71|STANDARD_ERROR_OF_MEAN|104.647||0.0322|TWO_SIDED|95.0|21.28|448.14||Difference between means, p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate,and percent change from baseline in AST as response variable.|ANCOVA|||||448.14|21.28|0.0322
74009145|NCT01010633|147569048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.0|||<|0.001|TWO_SIDED|95.0|21.4|40.7|||Chi-squared|||||40.7|21.4|<0.001
73949866|NCT02023879|147433529|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.7|||<|0.0001|TWO_SIDED|95.0|-57.1|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-46.4|-57.1|<0.0001
73870832|NCT01200368|147285892|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.83|||||TWO_SIDED|95.0|1.54|2.16||||||Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.16|1.54|
73870833|NCT01200368|147285892|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.89|||||TWO_SIDED|95.0|1.59|2.25||||||Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.25|1.59|
73949867|NCT02023879|147433530|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.3|||<|0.0001|TWO_SIDED|95.0|-39.8|-30.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.8|-39.8|<0.0001
73949868|NCT02023879|147433531|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-44.3|-32.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.1|-44.3|<0.0001
73949869|NCT02023879|147433532|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.9|||<|0.0001|TWO_SIDED|95.0|-43.9|-31.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.8|-43.9|<0.0001
73949870|NCT02023879|147433533|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.3|||<|0.0001|TWO_SIDED|95.0|-30.9|-21.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.7|-30.9|<0.0001
73977983|NCT02609048|147501933|SUPERIORITY||Difference in LSM|132.82|STANDARD_ERROR_OF_MEAN|96.015||0.1764|TWO_SIDED|95.0|-63.0|328.65||Difference between means, p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate,and percent change from baseline in AST as response variable.|ANCOVA|||||328.65|-63.00|0.1764
73977984|NCT02609048|147501933|SUPERIORITY||Difference in LSM|101.88|STANDARD_ERROR_OF_MEAN|103.504||0.3326|TWO_SIDED|95.0|-109.21|312.98||Difference between means, p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate, and percent change from baseline in AST as response variable.|ANCOVA|||||312.98|-109.21|0.3326
73977985|NCT02609048|147501934|SUPERIORITY||Difference in LSM|185.78|STANDARD_ERROR_OF_MEAN|104.379||0.0849|TWO_SIDED|95.0|-27.1|398.66||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline ALT assessment as covariate,and percent change from baseline in ALT as response variable.|ANCOVA|||||398.66|-27.10|0.0849
73977986|NCT02609048|147501934|SUPERIORITY||Difference in LSM|116.5|STANDARD_ERROR_OF_MEAN|97.437||0.2409|TWO_SIDED|95.0|-82.22|315.23||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline ALT assessment as covariate, and percent change from baseline in ALT as response variable.|ANCOVA|||||315.23|-82.22|0.2409
73949871|NCT02023879|147433534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|279.8|||<|0.0001|TWO_SIDED|95.0|29.1|2690.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||2690.1|29.1|<0.0001
73949872|NCT02023879|147433535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|354.7|||<|0.0001|TWO_SIDED|95.0|36.2|3479.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||3479.5|36.2|<0.0001
73977987|NCT02609048|147501934|SUPERIORITY||Difference in LSM|69.28|STANDARD_ERROR_OF_MEAN|105.295||0.5154|TWO_SIDED|95.0|-145.47|284.03||Difference between means,p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor,baseline ALT assessment as covariate, and percent change from baseline in ALT as response variable.|ANCOVA|||||284.03|-145.47|0.5154
73977988|NCT02609048|147501935|SUPERIORITY||Difference in LSM|-45.34|STANDARD_ERROR_OF_MEAN|12.112||0.0007|TWO_SIDED|95.0|-70.04|-20.64||Difference between means, p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||-20.64|-70.04|0.0007
73977989|NCT02609048|147501935|SUPERIORITY||Difference in LSM|-40.78|STANDARD_ERROR_OF_MEAN|11.033||0.0008|TWO_SIDED|95.0|-63.28|-18.28||Difference between means, p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||-18.28|-63.28|0.0008
73977990|NCT02609048|147501935|SUPERIORITY||Difference in LSM|-4.56|STANDARD_ERROR_OF_MEAN|12.401||0.7155|TWO_SIDED|95.0|-29.85|20.73||Difference between means, p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||20.73|-29.85|0.7155
73949873|NCT02023879|147433536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|126.0|||<|0.0001|TWO_SIDED|95.0|20.0|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9999|20.0|<0.0001
73870834|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
73870835|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
73949874|NCT02023879|147433537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|141.5|||<|0.0001|TWO_SIDED|95.0|22.2|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9999|22.2|<0.0001
73949875|NCT02023879|147433538|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.6||||0.0002|TWO_SIDED|95.0|-29.8|-9.4||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-9.4|-29.8|0.0002
73977991|NCT02609048|147501936|SUPERIORITY||Difference in LSM|-34.27|STANDARD_ERROR_OF_MEAN|11.342||0.005|TWO_SIDED|95.0|-57.4|-11.14||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||-11.14|-57.40|0.0050
73949876|NCT02023879|147433539|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.9||||0.0892|TWO_SIDED|95.0|-17.1|1.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.2|-17.1|0.0892
73949877|NCT04424290|147433557|OTHER||Adjusted mean difference|-0.0234|STANDARD_ERROR_OF_MEAN|0.0157|||TWO_SIDED|95.0|-0.0558|0.0089|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.0089|-0.0558|
73949878|NCT04424290|147433558|OTHER||Adjusted mean difference|0.0215|STANDARD_ERROR_OF_MEAN|0.0429|||TWO_SIDED|95.0|-0.067|0.11|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.1100|-0.0670|
73949879|NCT04424290|147433559|OTHER||Adjusted mean difference|-0.0109|STANDARD_ERROR_OF_MEAN|0.0145|||TWO_SIDED|95.0|-0.0412|0.0195|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.0195|-0.0412|
73977992|NCT02609048|147501936|SUPERIORITY||Difference in LSM|-24.84|STANDARD_ERROR_OF_MEAN|10.116||0.0199|TWO_SIDED|95.0|-45.47|-4.21||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||-4.21|-45.47|0.0199
73977993|NCT02609048|147501936|SUPERIORITY||Difference in LSM|-9.43|STANDARD_ERROR_OF_MEAN|11.442||0.4161|TWO_SIDED|95.0|-32.77|13.9||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||13.90|-32.77|0.4161
73977994|NCT02609048|147501937|SUPERIORITY||Difference in LSM|6.2|STANDARD_ERROR_OF_MEAN|8.626||0.478|TWO_SIDED|95.0|-11.4|23.79||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||23.79|-11.40|0.4780
73870836|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
73977995|NCT02609048|147501937|SUPERIORITY||Difference in LSM|-12.0|STANDARD_ERROR_OF_MEAN|8.043||0.1459|TWO_SIDED|95.0|-28.4|4.41||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||4.41|-28.40|0.1459
73949880|NCT04424290|147433560|OTHER||Adjusted mean difference|-0.0228|STANDARD_ERROR_OF_MEAN|0.0603|||TWO_SIDED|95.0|-0.1477|0.1021|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.1021|-0.1477|
73977996|NCT02609048|147501937|SUPERIORITY||Difference in LSM|18.19|STANDARD_ERROR_OF_MEAN|8.521||0.0407|TWO_SIDED|95.0|0.82|35.57||Difference between means,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||35.57|0.82|0.0407
73977997|NCT02609048|147501938|SUPERIORITY||Difference in LSM|31.47|STANDARD_ERROR_OF_MEAN|13.831||0.03|TWO_SIDED|95.0|3.26|59.67||Difference between means,p-value,and CIs are estimated by each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||59.67|3.26|0.0300
73977998|NCT02609048|147501938|SUPERIORITY||Difference in LSM|-8.84|STANDARD_ERROR_OF_MEAN|12.883||0.4979|TWO_SIDED|95.0|-35.11|17.44||Difference between means,p-value,and CIs are estimated by each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||17.44|-35.11|0.4979
73977999|NCT02609048|147501938|SUPERIORITY||Difference in LSM|40.3|STANDARD_ERROR_OF_MEAN|13.591||0.0058|TWO_SIDED|95.0|12.58|68.02||Difference between means,p-value,and CIs are estimated for Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||68.02|12.58|0.0058
73978000|NCT02609048|147501939|SUPERIORITY||Difference in LSM|-2.97|STANDARD_ERROR_OF_MEAN|8.362||0.7244|TWO_SIDED|95.0|-20.03|14.08||Difference between means,p-value, and CIs are estimated by comparing Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||14.08|-20.03|0.7244
73978001|NCT02609048|147501939|SUPERIORITY||Difference in LSM|-14.15|STANDARD_ERROR_OF_MEAN|7.819||0.08|TWO_SIDED|95.0|-30.1|1.8||Difference between means,p-value, and CIs are estimated by comparing Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||1.80|-30.10|0.0800
73978002|NCT02609048|147501939|SUPERIORITY||Difference in LSM|11.18|STANDARD_ERROR_OF_MEAN|8.29||0.1874|TWO_SIDED|95.0|-5.73|28.08||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||28.08|-5.73|0.1874
73978003|NCT02609048|147501940|SUPERIORITY||Difference in LSM|-45.96|STANDARD_ERROR_OF_MEAN|6.638|<|0.0001|TWO_SIDED|95.0|-59.5|-32.42||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-32.42|-59.50|<0.0001
73978004|NCT02609048|147501940|SUPERIORITY||Difference in LSM|-34.66|STANDARD_ERROR_OF_MEAN|6.46|<|0.0001|TWO_SIDED|95.0|-47.83|-21.48||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-21.48|-47.83|<0.0001
73978005|NCT02609048|147501940|SUPERIORITY||Difference in LSM|-11.3|STANDARD_ERROR_OF_MEAN|6.508||0.0924|TWO_SIDED|95.0|-24.58|1.97||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||1.97|-24.58|0.0924
73978006|NCT02609048|147501941|SUPERIORITY||Difference in LSM|-14.15|STANDARD_ERROR_OF_MEAN|12.807||0.2777|TWO_SIDED|95.0|-40.27|11.97||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||11.97|-40.27|0.2777
73978007|NCT02609048|147501941|SUPERIORITY||Difference in LSM|-37.31|STANDARD_ERROR_OF_MEAN|11.946||0.0039|TWO_SIDED|95.0|-61.67|-12.95||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||-12.95|-61.67|0.0039
73978008|NCT02609048|147501941|SUPERIORITY||Difference in LSM|23.16|STANDARD_ERROR_OF_MEAN|12.498||0.0734|TWO_SIDED|95.0|-2.33|48.65||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||48.65|-2.33|0.0734
73978009|NCT02609048|147501942|SUPERIORITY||Difference in LSM|-16.12|STANDARD_ERROR_OF_MEAN|4.433||0.001|TWO_SIDED|95.0|-25.16|-7.07||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||-7.07|-25.16|0.0010
73978010|NCT02609048|147501942|SUPERIORITY||Difference in LSM|-8.13|STANDARD_ERROR_OF_MEAN|3.992||0.0504|TWO_SIDED|95.0|-16.27|0.02||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||0.02|-16.27|0.0504
73978011|NCT02609048|147501942|SUPERIORITY||Difference in LSM|-7.99|STANDARD_ERROR_OF_MEAN|4.317||0.0738|TWO_SIDED|95.0|-16.8|0.81||Difference between means,p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||0.81|-16.80|0.0738
73978012|NCT02609048|147501943|SUPERIORITY||Difference in LSM|-17.39|STANDARD_ERROR_OF_MEAN|5.848||0.0057|TWO_SIDED|95.0|-29.32|-5.46||Difference between means,p-value,and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||-5.46|-29.32|0.0057
73978013|NCT02609048|147501943|SUPERIORITY||Difference in LSM|-0.89|STANDARD_ERROR_OF_MEAN|5.378||0.8703|TWO_SIDED|95.0|-11.85|10.08||Difference between means,p-value,and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||10.08|-11.85|0.8703
73978014|NCT02609048|147501943|SUPERIORITY||Difference in LSM|-16.51|STANDARD_ERROR_OF_MEAN|5.781||0.0076|TWO_SIDED|95.0|-28.3|-4.71||Difference between means,p-value,and CIs estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||-4.71|-28.30|0.0076
73978015|NCT02609048|147501944|SUPERIORITY||Difference in LSM|-14.85|STANDARD_ERROR_OF_MEAN|5.981||0.0186|TWO_SIDED|95.0|-27.05|-2.66||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||-2.66|-27.05|0.0186
73978016|NCT02609048|147501944|SUPERIORITY||Difference in LSM|-10.06|STANDARD_ERROR_OF_MEAN|5.448||0.0745|TWO_SIDED|95.0|-21.17|1.06||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||1.06|-21.17|0.0745
73978017|NCT02609048|147501944|SUPERIORITY||Difference in LSM|-4.8|STANDARD_ERROR_OF_MEAN|5.785||0.4131|TWO_SIDED|95.0|-16.6|7.0||Difference between means,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||7.00|-16.60|0.4131
73978018|NCT02609048|147501945|SUPERIORITY|||||||0.4667||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.4667
73978019|NCT02609048|147501945|SUPERIORITY|||||||0.4667||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||0.4667
73978020|NCT02609048|147501946|SUPERIORITY|||||||0.0824||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0824
73978021|NCT02609048|147501946|SUPERIORITY|||||||0.0537||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0537
73978022|NCT02609048|147501946|SUPERIORITY|||||||1||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||1.0000
73978023|NCT02609048|147501947|SUPERIORITY|||||||0.0101||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0101
73978024|NCT02609048|147501947|SUPERIORITY|||||||0.0198||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0198
73978025|NCT02609048|147501947|SUPERIORITY|||||||0.5165||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||0.5165
73978026|NCT02609048|147501948|SUPERIORITY|||||||0.0101||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0101
73978027|NCT02609048|147501948|SUPERIORITY|||||||0.0055||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0055
73978028|NCT02609048|147501948|SUPERIORITY|||||||1||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||1.0000
73978029|NCT02609048|147501950|SUPERIORITY||Difference in LSM|-1.1|STANDARD_ERROR_OF_MEAN|1.82||0.5379|TWO_SIDED|95.0|-4.8|2.6||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||2.6|-4.8|0.5379
73978030|NCT02609048|147501950|SUPERIORITY||Difference in LSM|0.2|STANDARD_ERROR_OF_MEAN|1.7||0.8949|TWO_SIDED|95.0|-3.3|3.7||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||3.7|-3.3|0.8949
73978031|NCT02609048|147501950|SUPERIORITY||Difference in LSM|-1.4|STANDARD_ERROR_OF_MEAN|1.75||0.4431|TWO_SIDED|95.0|-4.9|2.2||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||2.2|-4.9|0.4431
73978032|NCT02609048|147501951|SUPERIORITY||Difference in LSM|-7.4|STANDARD_ERROR_OF_MEAN|10.07||0.4674|TWO_SIDED|95.0|-28.0|13.2||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||13.2|-28.0|0.4674
73978033|NCT02609048|147501951|SUPERIORITY||Difference in LSM|-9.0|STANDARD_ERROR_OF_MEAN|8.99||0.3236|TWO_SIDED|95.0|-27.4|9.4||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||9.4|-27.4|0.3236
73978034|NCT02609048|147501951|SUPERIORITY||Difference in LSM|1.6|STANDARD_ERROR_OF_MEAN|9.92||0.8723|TWO_SIDED|95.0|-18.7|21.9||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||21.9|-18.7|0.8723
73978035|NCT02609048|147501952|SUPERIORITY||Difference in LSM|3.4|STANDARD_ERROR_OF_MEAN|1.25||0.0115|TWO_SIDED|95.0|0.8|6.0||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||6.0|0.8|0.0115
73978036|NCT02609048|147501952|SUPERIORITY||Difference in LSM|1.8|STANDARD_ERROR_OF_MEAN|1.1||0.1256|TWO_SIDED|95.0|-0.5|4.0||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||4.0|-0.5|0.1256
73978037|NCT02609048|147501952|SUPERIORITY||Difference in LSM|1.7|STANDARD_ERROR_OF_MEAN|1.22||0.1842|TWO_SIDED|95.0|-0.9|4.2||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||4.2|-0.9|0.1842
74009146|NCT02463071|147569050|SUPERIORITY||Mean Difference (Final Values)|-26.72|STANDARD_ERROR_OF_MEAN|4.96|<|0.0001|TWO_SIDED|95.0|-36.55|-16.88|||ANCOVA|Baseline TG and statin usage were included as covariates.||||-16.88|-36.55|<0.0001
73870837|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
73870838|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
73870839|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-0.6|||||TWO_SIDED|95.0|-3.9|2.4||||||Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-3.9|
73870840|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
73870841|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.9|3.0||||||Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.0|-2.9|
73949881|NCT04424290|147433561|OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-8.1|5.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||5.5|-8.1|
74032479|NCT04742907|147618153|SUPERIORITY||Odds Ratio (OR)|1.8||||0.122|TWO_SIDED|95.0|0.85|3.78||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||3.78|0.85|0.122
73870842|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.9|3.0||||||Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.0|-2.9|
73870843|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
73870844|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
73870845|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
73949882|NCT04424290|147433562|OTHER||Adjusted mean difference|4.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-7.3|16.2|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||16.2|-7.3|
73949883|NCT04424290|147433563|OTHER||Adjusted mean difference|-3.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.6|3.0|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||3.0|-9.6|
73949884|NCT04424290|147433564|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-7.3|6.1|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||6.1|-7.3|
73949885|NCT04424290|147433565|OTHER||Adjusted mean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-8.7|3.1|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||3.1|-8.7|
73949886|NCT04424290|147433566|OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-4.9|5.4|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||5.4|-4.9|
73978038|NCT02609048|147501952|SUPERIORITY||Difference in LSM|3.7|STANDARD_ERROR_OF_MEAN|1.7||0.042|TWO_SIDED|95.0|0.1|7.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||7.2|0.1|0.0420
73978039|NCT02609048|147501952|SUPERIORITY||Difference in LSM|0.7|STANDARD_ERROR_OF_MEAN|1.54||0.6384|TWO_SIDED|95.0|-2.4|3.9||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||3.9|-2.4|0.6384
73978040|NCT02609048|147501952|SUPERIORITY||Difference in LSM|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.1035|TWO_SIDED|95.0|-0.6|6.5||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||6.5|-0.6|0.1035
73978041|NCT02609048|147501952|SUPERIORITY||Difference in LSM|0.4|STANDARD_ERROR_OF_MEAN|0.96||0.6967|TWO_SIDED|95.0|-1.6|2.4||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Emotional Function Domain Score||2.4|-1.6|0.6967
74009147|NCT02463071|147569050|SUPERIORITY||Mean Difference (Final Values)|-32.92|STANDARD_ERROR_OF_MEAN|5.04|<|0.0001|TWO_SIDED|95.0|-42.93|-22.92|||ANCOVA|Baseline TG and statin usage were included as covariates.||||-22.92|-42.93|<0.0001
73949887|NCT04424290|147433567|OTHER||Adjusted mean difference|2.6|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-2.7|7.9|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||7.9|-2.7|
73949888|NCT04424290|147433568|OTHER||Adjusted mean difference|7.7|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-1.2|16.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||16.5|-1.2|
73949889|NCT04424290|147433569|OTHER||Adjusted mean difference|13.8|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-2.3|29.8|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||29.8|-2.3|
73949890|NCT04424290|147433570|OTHER||Adjusted mean difference|6.8|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-0.9|14.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||14.5|-0.9|
73949891|NCT04249336|147433581|SUPERIORITY||Mean Difference (Net)|36.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
73949892|NCT04249336|147433581|SUPERIORITY||Mean Difference (Net)|33.0|||<|0.05|TWO_SIDED|95.0||||Threshold P\<0.05|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
73949893|NCT04249336|147433581|SUPERIORITY||Mean Difference (Net)|23.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
73949894|NCT04249336|147433582|SUPERIORITY||Mean Difference (Net)|32.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANCOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
73949895|NCT04249336|147433582|SUPERIORITY||Mean Difference (Net)|39.0|||<|0.05|TWO_SIDED|||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
73949896|NCT04249336|147433582|SUPERIORITY||Mean Difference (Net)|30.0|||<|0.05|TWO_SIDED|||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
73949897|NCT04249336|147433583|SUPERIORITY||Median Difference (Net)|36.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANCOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
73949898|NCT04249336|147433583|SUPERIORITY||Mean Difference (Net)|28.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
73949899|NCT04249336|147433583|SUPERIORITY||Mean Difference (Net)|25.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
73949900|NCT01242176|147433584|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.67|STANDARD_DEVIATION|6.7|||TWO_SIDED|90.0|98.1|105.37|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV).|Ratio calculated as empa final formulation divided by empa trial formulation 2||105.37|98.10|
73949901|NCT01242176|147433585|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|99.46|STANDARD_DEVIATION|18.7|||TWO_SIDED|90.0|90.18|109.68|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2||109.68|90.18|
73949902|NCT01242176|147433586|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.8|STANDARD_DEVIATION|6.7|||TWO_SIDED|90.0|98.26|105.48|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2||105.48|98.26|
73949903|NCT03390036|147433587|SUPERIORITY|||||||0.8106|||||||ANOVA|||||||0.8106
73949904|NCT03390036|147433588|SUPERIORITY|||||||0.3007|||||||ANOVA|||||||0.3007
73949905|NCT03390036|147433589|SUPERIORITY|||||||0.6354|||||||ANOVA|||||||0.6354
73949906|NCT03390036|147433590|SUPERIORITY|||||||0.5754|||||||ANOVA|||||||0.5754
73949907|NCT03390036|147433591|SUPERIORITY|||||||0.4759|||||||ANOVA|||||||0.4759
73949908|NCT03390036|147433592|SUPERIORITY|||||||0.5596|||||||ANOVA|||||||0.5596
73949909|NCT03390036|147433593|SUPERIORITY|||||||0.4551|||||||ANOVA|||||||0.4551
73949910|NCT03390036|147433594|SUPERIORITY|||||||0.7931|||||||ANOVA|||||||0.7931
73949911|NCT00358215|147433595|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.871|TWO_SIDED|95.0|0.9|1.13||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none)|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.13|0.90|0.871
73949912|NCT00358215|147433596|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.512|TWO_SIDED|95.0|0.92|1.19||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.19|0.92|0.512
73949913|NCT00358215|147433597|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.922|TWO_SIDED|95.0|0.89|1.14||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.14|0.89|0.922
73949914|NCT00358215|147433598|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.79||0.005|TWO_SIDED|95.0|0.65|3.75|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.||||3.75|0.65|0.005
73949915|NCT00358215|147433599|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|0.9||0.011|TWO_SIDED|95.0|0.53|4.05|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.||||4.05|0.53|0.011
73949916|NCT01987596|147433640|SUPERIORITY|||||||1|||||||McNemar|||||||1.00
73949917|NCT01987596|147433641|SUPERIORITY||||||<|0.0001|||||||ANOVA|||two-period crossover design analysis||||<0.0001
73949918|NCT01987596|147433642|SUPERIORITY||||||<|0.0001|||||||ANOVA|||2 treatment, 2 periiod cross-over analysis||||<0.0001
73949919|NCT00179010|147433673|SUPERIORITY_OR_OTHER|||||||0.854|||||||ANOVA|||||||0.854
73949920|NCT00453479|147433688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|5.596|||TWO_SIDED|95.0|-12.68|10.75|||||Comparison of SBP Day 1.|||10.75|-12.68|
73949921|NCT00453479|147433688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|4.215|||TWO_SIDED|95.0|-12.92|4.72|||||Comparison of SBP Day 7.|||4.72|-12.92|
73949922|NCT00453479|147433688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.21|STANDARD_ERROR_OF_MEAN|5.727|||TWO_SIDED|95.0|-5.78|18.19|||||Comparison of SBP Day 1.|||18.19|-5.78|
73949923|NCT00453479|147433688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.76|STANDARD_ERROR_OF_MEAN|4.314|||TWO_SIDED|95.0|-13.79|4.27|||||Comparison of SBP Day 7.|||4.27|-13.79|
73949924|NCT00453479|147433688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|2.138|||TWO_SIDED|95.0|-3.89|5.06|||||Comparison of DBP Day 1.|||5.06|-3.89|
73949925|NCT00453479|147433688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.64|STANDARD_ERROR_OF_MEAN|2.382|||TWO_SIDED|95.0|-11.62|-1.65|||||Comparison of DBP Day 7.|||-1.65|-11.62|
73949926|NCT00453479|147433688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|2.248|||TWO_SIDED|95.0|-3.73|5.68|||||Comparison of DBP Day 1.|||5.68|-3.73|
73949927|NCT00453479|147433688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.81|STANDARD_ERROR_OF_MEAN|2.504|||TWO_SIDED|95.0|-16.05|-5.57|||||Comparison of DBP Day 7.|||-5.57|-16.05|
73949928|NCT00453479|147433689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|3.745|||TWO_SIDED|95.0|-5.58|10.1|||||Comparison at Day 1.|||10.10|-5.58|
73949929|NCT00453479|147433689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.62|STANDARD_ERROR_OF_MEAN|3.785|||TWO_SIDED|95.0|-5.3|10.54|||||Comparison at Day 7.|||10.54|-5.30|
73949930|NCT00453479|147433689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|3.979|||TWO_SIDED|95.0|-8.17|8.48|||||Comparison at Day 1.|||8.48|-8.17|
73949931|NCT00453479|147433689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.44|STANDARD_ERROR_OF_MEAN|4.021|||TWO_SIDED|95.0|-13.86|2.97|||||Comparison at Day 7.|||2.97|-13.86|
73949932|NCT00453479|147433690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.78|STANDARD_ERROR_OF_MEAN|4.611|||TWO_SIDED|95.0|-12.43|6.87|||||Comparison of SBP Day 1.|||6.87|-12.43|
73949933|NCT00453479|147433690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|3.913|||TWO_SIDED|95.0|-10.07|6.31|||||Comparison of SBP Day 7.|||6.31|-10.07|
73949934|NCT00453479|147433690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.01|STANDARD_ERROR_OF_MEAN|4.718|||TWO_SIDED|95.0|-6.87|12.88|||||Comparison of SBP Day 1.|||12.88|-6.87|
73949935|NCT00453479|147433690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|4.005|||TWO_SIDED|95.0|-11.88|4.89|||||Comparison of SBP Day 7.|||4.89|-11.88|
73949936|NCT00453479|147433690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.822|||TWO_SIDED|95.0|-4.09|3.54|||||Comparison of DBP Day 1.|||3.54|-4.09|
73949937|NCT00453479|147433690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.89|STANDARD_ERROR_OF_MEAN|2.116|||TWO_SIDED|95.0|-8.32|0.54|||||Comparison of DBP Day 7.|||0.54|-8.32|
73949938|NCT00453479|147433690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|1.916|||TWO_SIDED|95.0|-5.76|2.26|||||Comparison of DBP Day 1.|||2.26|-5.76|
73949939|NCT00453479|147433690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.39|STANDARD_ERROR_OF_MEAN|2.224|||TWO_SIDED|95.0|-14.04|-4.73|||||Comparison of DBP Day 7.|||-4.73|-14.04|
73949940|NCT00453479|147433691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.52|5.79|||||Comparison at Day 1.|||5.79|-5.52|
73949941|NCT00453479|147433691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|2.813|||TWO_SIDED|95.0|-3.5|8.28|||||Comparison at Day 7.|||8.28|-3.50|
73978042|NCT02609048|147501952|SUPERIORITY||Difference in LSM|0.4|STANDARD_ERROR_OF_MEAN|0.85||0.6164|TWO_SIDED|95.0|-1.3|2.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Emotional Function Domain Score||2.2|-1.3|0.6164
73949942|NCT00453479|147433691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.67|STANDARD_ERROR_OF_MEAN|2.869|||TWO_SIDED|95.0|-8.67|3.34|||||Comparison at Day 1.|||3.34|-8.67|
73949943|NCT00453479|147433691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.84|STANDARD_ERROR_OF_MEAN|2.989|||TWO_SIDED|95.0|-10.1|2.41|||||Comparison at Day 7.|||2.41|-10.10|
73949944|NCT00453479|147433693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.42|STANDARD_ERROR_OF_MEAN|8.157|||TWO_SIDED|95.0|-12.66|21.49|||||Comparison of QTcB Day 1.|||21.49|-12.66|
73949945|NCT00453479|147433693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.02|STANDARD_ERROR_OF_MEAN|6.76|||TWO_SIDED|95.0|-5.13|23.17|||||Comparison of QTcB Day 7.|||23.17|-5.13|
73949946|NCT00453479|147433693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.57|STANDARD_ERROR_OF_MEAN|8.51|||TWO_SIDED|95.0|-7.24|28.38|||||Comparison of QTcB Day 1.|||28.38|-7.24|
73949947|NCT00453479|147433693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.5|STANDARD_ERROR_OF_MEAN|7.052|||TWO_SIDED|95.0|1.74|31.26|||||Comparison of QTcB Day 7.|||31.26|1.74|
73949948|NCT00453479|147433693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.13|STANDARD_ERROR_OF_MEAN|8.908|||TWO_SIDED|95.0|-16.51|20.78|||||Comparison of QTcF Day 1.|||20.78|-16.51|
73949949|NCT00453479|147433693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.29|STANDARD_ERROR_OF_MEAN|5.298|||TWO_SIDED|95.0|1.2|23.38|||||Comparison of QTcF Day 7.|||23.38|1.20|
73949950|NCT00453479|147433693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.66|STANDARD_ERROR_OF_MEAN|9.171|||TWO_SIDED|95.0|-1.53|36.85|||||Comparison of QTcF Day 1.|||36.85|-1.53|
73949951|NCT00453479|147433693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.32|STANDARD_ERROR_OF_MEAN|5.454|||TWO_SIDED|95.0|10.9|33.73|||||Comparison of QTcF Day 7.|||33.73|10.90|
73949952|NCT00453479|147433694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.55|STANDARD_ERROR_OF_MEAN|5.262|||TWO_SIDED|95.0|-1.46|20.57|||||Comparison of QTcB Day 1.|||20.57|-1.46|
73949953|NCT00453479|147433694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.39|STANDARD_ERROR_OF_MEAN|5.902|||TWO_SIDED|95.0|-3.97|20.74|||||Comparison of QTcB Day 7.|||20.74|-3.97|
73949954|NCT00453479|147433694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.47|STANDARD_ERROR_OF_MEAN|5.49|||TWO_SIDED|95.0|-0.02|22.96|||||Comparison of QTcB Day 1.|||22.96|-0.02|
73949955|NCT00453479|147433694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.28|STANDARD_ERROR_OF_MEAN|6.157|||TWO_SIDED|95.0|2.39|28.17|||||Comparison of QTcB Day 7.|||28.17|2.39|
73949956|NCT00453479|147433694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.32|STANDARD_ERROR_OF_MEAN|4.622|||TWO_SIDED|95.0|-1.35|18.0|||||Comparison of QTcF Day 1.|||18.00|-1.35|
73949957|NCT00453479|147433694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.75|STANDARD_ERROR_OF_MEAN|5.239|||TWO_SIDED|95.0|-2.21|19.72|||||Comparison of QTcF Day 7.|||19.72|-2.21|
73949958|NCT00453479|147433694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.83|STANDARD_ERROR_OF_MEAN|4.759|||TWO_SIDED|95.0|6.87|26.79|||||Comparison of QTcF Day 1.|||26.79|6.87|
73949959|NCT00453479|147433694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.46|STANDARD_ERROR_OF_MEAN|5.394|||TWO_SIDED|95.0|9.17|31.75|||||Comparison of QTcF Day 7.|||31.75|9.17|
73949960|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|95.0|-0.035|0.328|||||Comparison of FEV1, Day 1, 1 hour|||0.328|-0.035|
73949961|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.171|STANDARD_ERROR_OF_MEAN|0.0944|||TWO_SIDED|95.0|-0.015|0.357|||||Comparison of FEV1, Day 1, 2 hour|||0.357|-0.015|
73949962|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|95.0|-0.107|0.228|||||Comparison of FEV1, Day 1, 4 hour|||0.228|-0.107|
73949963|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.1195|||TWO_SIDED|95.0|-0.085|0.386|||||Comparison of FEV1, Day 1, 9 hour|||0.386|-0.085|
73949964|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.124|STANDARD_ERROR_OF_MEAN|0.1107|||TWO_SIDED|95.0|-0.094|0.343|||||Comparison of FEV1, Day 1, 12 hour|||0.343|-0.094|
73949965|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.163|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.077|0.404|||||Comparison of FEV1, Day 1, 24 hour|||0.404|-0.077|
73949966|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.236|STANDARD_ERROR_OF_MEAN|0.1057|||TWO_SIDED|95.0|0.027|0.444|||||Comparison of FEV1, Day 7, Baseline|||0.444|0.027|
73949967|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.229|STANDARD_ERROR_OF_MEAN|0.1292|||TWO_SIDED|95.0|-0.026|0.483|||||Comparison of FEV1, Day 7, 1 hour|||0.483|-0.026|
73949968|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.095|STANDARD_ERROR_OF_MEAN|0.1309|||TWO_SIDED|95.0|-0.163|0.353|||||Comparison of FEV1, Day 7, 2 hour|||0.353|-0.163|
74089319|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0005|TWO_SIDED|95.0|1.48|4.01|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.01|1.48|0.0005
74089320|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0006|TWO_SIDED|95.0|1.45|3.94|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.94|1.45|0.0006
73949969|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.173|STANDARD_ERROR_OF_MEAN|0.1243|||TWO_SIDED|95.0|-0.072|0.418|||||Comparison of FEV1, Day 7, 4 hour|||0.418|-0.072|
73949970|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.205|STANDARD_ERROR_OF_MEAN|0.1499|||TWO_SIDED|95.0|-0.09|0.501|||||Comparison of FEV1, Day 7, 9 hour|||0.501|-0.090|
73949971|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|-0.062|0.502|||||Comparison of FEV1, Day 7, 12 hour|||0.502|-0.062|
73949972|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.206|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|95.0|-0.093|0.506|||||Comparison of FEV1, Day 7, 24 hour|||0.506|-0.093|
73978043|NCT02609048|147501952|SUPERIORITY||Difference in LSM|-0.1|STANDARD_ERROR_OF_MEAN|0.93||0.9548|TWO_SIDED|95.0|-2.0|1.9|||ANCOVA|||Emotional Function Domain Score||1.9|-2.0|0.9548
73978044|NCT02609048|147501952|SUPERIORITY||Difference in LSM|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.8286|TWO_SIDED|95.0|-2.4|1.9||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||1.9|-2.4|0.8286
73978045|NCT02609048|147501952|SUPERIORITY||Difference in LSM|4.2|STANDARD_ERROR_OF_MEAN|1.74||0.0226|TWO_SIDED|95.0|0.6|7.8||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||7.8|0.6|0.0226
73978046|NCT02609048|147501952|SUPERIORITY||Difference in LSM|-2.6|STANDARD_ERROR_OF_MEAN|1.92||0.1861|TWO_SIDED|95.0|-6.6|1.4||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||1.4|-6.6|0.1861
73978047|NCT02609048|147501952|SUPERIORITY||Difference in LSM|1.6|STANDARD_ERROR_OF_MEAN|1.96||0.4159|TWO_SIDED|95.0|-2.4|5.7||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||5.7|-2.4|0.4159
73978048|NCT02609048|147501952|SUPERIORITY||Difference in LSM|0.7|STANDARD_ERROR_OF_MEAN|0.93||0.4848|TWO_SIDED|95.0|-1.3|2.6||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||2.6|-1.3|0.4848
73978049|NCT02609048|147501952|SUPERIORITY||Difference in LSM|-0.9|STANDARD_ERROR_OF_MEAN|1.05||0.4048|TWO_SIDED|95.0|-3.1|1.3||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||1.3|-3.1|0.4048
73978050|NCT02609048|147501952|SUPERIORITY||Difference in LSM|2.6|STANDARD_ERROR_OF_MEAN|1.0||0.0141|TWO_SIDED|95.0|0.6|4.7||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||4.7|0.6|0.0141
73978051|NCT02609048|147501952|SUPERIORITY||Difference in LSM|2.4|STANDARD_ERROR_OF_MEAN|0.9||0.0138|TWO_SIDED|95.0|0.5|4.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||4.2|0.5|0.0138
74089321|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0436|TWO_SIDED|95.0|1.02|4.32|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.32|1.02|0.0436
73949973|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.206|STANDARD_ERROR_OF_MEAN|0.097|||TWO_SIDED|95.0|0.015|0.397|||||Comparison of FEV1, Day 1, 1 hour|||0.397|0.015|
73949974|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.329|STANDARD_ERROR_OF_MEAN|0.0994|||TWO_SIDED|95.0|0.133|0.525|||||Comparison of FEV1, Day 1, 2 hour|||0.525|0.133|
73949975|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.266|STANDARD_ERROR_OF_MEAN|0.0895|||TWO_SIDED|95.0|0.09|0.443|||||Comparison of FEV1, Day 1, 4 hour|||0.443|0.090|
73949976|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.1258|||TWO_SIDED|95.0|0.072|0.568|||||Comparison of FEV1, Day 1, 9 hour|||0.568|0.072|
73949977|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.172|STANDARD_ERROR_OF_MEAN|0.1165|||TWO_SIDED|95.0|-0.058|0.402|||||Comparison of FEV1, Day 1, 12 hour|||0.402|-0.058|
73949978|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.1285|||TWO_SIDED|95.0|-0.099|0.407|||||Comparison of FEV1, Day 1, 24 hour|||0.407|-0.099|
73949979|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.256|STANDARD_ERROR_OF_MEAN|0.1113|||TWO_SIDED|95.0|0.036|0.475|||||Comparison of FEV1, Day 7, Baseline|||0.475|0.036|
73949980|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.296|STANDARD_ERROR_OF_MEAN|0.1361|||TWO_SIDED|95.0|0.027|0.564|||||Comparison of FEV1, Day 7, 1 hour|||0.564|0.027|
73949981|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.202|STANDARD_ERROR_OF_MEAN|0.1378|||TWO_SIDED|95.0|-0.069|0.474|||||Comparison of FEV1, Day 7, 2 hour|||0.474|-0.069|
73949982|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.207|STANDARD_ERROR_OF_MEAN|0.1309|||TWO_SIDED|95.0|-0.051|0.465|||||Comparison of FEV1, Day 7, 4 hour|||0.465|-0.051|
73949983|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.1579|||TWO_SIDED|95.0|-0.032|0.591|||||Comparison of FEV1, Day 7, 9 hour|||0.591|-0.032|
73949984|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.193|STANDARD_ERROR_OF_MEAN|0.1506|||TWO_SIDED|95.0|-0.104|0.49|||||Comparison of FEV1, Day 7, 12 hour|||0.490|-0.104|
73949985|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.1601|||TWO_SIDED|95.0|-0.136|0.495|||||Comparison of FEV1, Day 7, 24 hour|||0.495|-0.136|
73978052|NCT02609048|147501952|SUPERIORITY||Difference in LSM|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7911|TWO_SIDED|95.0|-1.8|2.3||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||2.3|-1.8|0.7911
73978053|NCT02485925|147501953|OTHER||Proportion of participants|80.7|||||TWO_SIDED|95.0|73.9|86.4|||||||95% confidence interval is based on Clopper-Pearson confidence interval|86.4|73.9|
73949986|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.137|STANDARD_ERROR_OF_MEAN|0.2029|||TWO_SIDED|95.0|-0.263|0.537|||||Comparison of FVC, Day 1, 1 hour|||0.537|-0.263|
73978054|NCT02485925|147501954|OTHER||Proportion of participants|99.5|||||TWO_SIDED|95.0|97.2|100.0|||||||95% confidence interval is based on Clopper-Pearson confidence interval|100.0|97.2|
73949987|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.1965|||TWO_SIDED|95.0|-0.257|0.518|||||Comparison of FVC, Day 1, 2 hour|||0.518|-0.257|
73978055|NCT04181788|147501963|OTHER|Ratio of experimental vs control|Ratio of experimental vs control|231.2|||||TWO_SIDED|90.0|190.09|281.21||||||Phase 2 600 mg SC Q6W (experimental) vs. Phase 2 300 mg SC Q4W (control)||281.21|190.09|
73978056|NCT04181788|147501964|OTHER|Ratio of experimental vs control|Ratio of experimental vs control|111.48|||||TWO_SIDED|90.0|86.31|143.99||||||Phase 2 600 mg SC Q6W (experimental) vs. Phase 2 300 mg SC Q4W (control)||143.99|86.31|
73978057|NCT06922643|147501997|OTHER||Odds Ratio (OR)|6.73||||0.008|TWO_SIDED|95.0|1.63|27.8|||Regression, Logistic|||||27.8|1.63|0.008
73978058|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Erythema||0.141|-0.216|
73978059|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Swelling||0.141|-0.216|
74089322|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1348|TWO_SIDED|95.0|0.84|3.69|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.69|0.84|0.1348
74089323|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.58|3.36|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.36|1.58|<.0001
74089324|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.46|3.09|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.09|1.46|<.0001
73949988|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.038|STANDARD_ERROR_OF_MEAN|0.1908|||TWO_SIDED|95.0|-0.414|0.338|||||Comparison of FVC, Day 1, 4 hour|||0.338|-0.414|
73949989|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.2013|||TWO_SIDED|95.0|-0.337|0.457|||||Comparison of FVC, Day 1, 9 hour|||0.457|-0.337|
73949990|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.2322|||TWO_SIDED|95.0|-0.343|0.572|||||Comparison of FVC, Day 1, 12 hour|||0.572|-0.343|
73949991|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.1988|||TWO_SIDED|95.0|-0.277|0.507|||||Comparison of FVC, Day 1, 24 hour|||0.507|-0.277|
73949992|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.362|STANDARD_ERROR_OF_MEAN|0.2801|||TWO_SIDED|95.0|-0.19|0.914|||||Comparison of FVC, Day 7, Baseline|||0.914|-0.190|
73949993|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.269|STANDARD_ERROR_OF_MEAN|0.2696|||TWO_SIDED|95.0|-0.263|0.8|||||Comparison of FVC, Day 7, 1 hour|||0.800|-0.263|
73978060|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.135|0.119|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|ALT Increased||0.119|-0.135|
73978061|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.135|0.119|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Hemoglobin Decreased||0.119|-0.135|
73978062|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.205|0.121|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Leukocytosis||0.121|-0.205|
73978063|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.024|||||TWO_SIDED|95.0|-0.127|0.111|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|PTT Prolonged||0.111|-0.127|
73978064|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.056|||||TWO_SIDED|95.0|0.022|0.134|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Thrombocytopenia||0.134|0.022|
73978065|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.051|||||TWO_SIDED|95.0|0.018|0.118|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Fever||0.118|0.018|
73978066|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|-0.036|||||TWO_SIDED|95.0|-0.203|0.089|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Headache||0.089|-0.203|
73870846|NCT01200368|147285893|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
73870847|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.77|1.15||||||Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.15|0.77|
73870848|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.23|||||TWO_SIDED|95.0|0.98|1.53||||||Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.53|0.98|
73870849|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.81|||||TWO_SIDED|95.0|0.67|0.98||||||Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.67|
73870850|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.81|1.12||||||Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.12|0.81|
73870851|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.82|||||TWO_SIDED|95.0|0.67|1.01||||||Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.01|0.67|
73978067|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.166|||||TWO_SIDED|95.0|0.016|0.275|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Rash||0.275|0.016|
73870852|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.75|||||TWO_SIDED|95.0|1.39|2.21||||||Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||2.21|1.39|
73978068|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.063|||||TWO_SIDED|95.0|0.03|0.126|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Arthralgia||0.126|0.030|
73978069|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.023|||||TWO_SIDED|95.0|-0.155|0.118|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Fatigue||0.118|-0.155|
73870853|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.86|||||TWO_SIDED|95.0|0.7|1.07||||||Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.07|0.70|
73870854|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.62|||||TWO_SIDED|95.0|1.31|1.99||||||Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.99|1.31|
73870855|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.29|||||TWO_SIDED|95.0|0.24|0.35||||||Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||0.35|0.24|
73870856|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.28|||||TWO_SIDED|95.0|1.07|1.54||||||Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.54|1.07|
73870857|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.76|||||TWO_SIDED|95.0|1.46|2.12||||||Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.12|1.46|
73870858|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.26|||||TWO_SIDED|95.0|1.04|1.52||||||Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.52|1.04|
73870859|NCT01200368|147285894|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.85|||||TWO_SIDED|95.0|1.54|2.24||||||Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.24|1.54|
73870860|NCT01200368|147285895|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
73870861|NCT01200368|147285895|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
73978070|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.041|||||TWO_SIDED|95.0|-0.105|0.105|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Myalgia||0.105|-0.105|
73978071|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.019|||||TWO_SIDED|95.0|-0.16|0.114|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Nausea||0.114|-0.160|
73949994|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.2648|||TWO_SIDED|95.0|-0.501|0.543|||||Comparison of FVC, Day 7, 2 hour|||0.543|-0.501|
73949995|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.177|STANDARD_ERROR_OF_MEAN|0.2606|||TWO_SIDED|95.0|-0.337|0.691|||||Comparison of FVC, Day 7, 4 hour|||0.691|-0.337|
73949996|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.266|STANDARD_ERROR_OF_MEAN|0.2684|||TWO_SIDED|95.0|-0.263|0.795|||||Comparison of FVC, Day 7, 9 hour|||0.795|-0.263|
73949997|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.2923|||TWO_SIDED|95.0|-0.209|0.943|||||Comparison of FVC, Day 7, 12 hour|||0.943|-0.209|
73949998|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.242|STANDARD_ERROR_OF_MEAN|0.2665|||TWO_SIDED|95.0|-0.283|0.768|||||Comparison of FVC, Day 7, 24 hour|||0.768|-0.283|
73949999|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.152|STANDARD_ERROR_OF_MEAN|0.2106|||TWO_SIDED|95.0|-0.263|0.567|||||Comparison of FVC, Day 1, 1 hour|||0.567|-0.263|
73950000|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.321|STANDARD_ERROR_OF_MEAN|0.2039|||TWO_SIDED|95.0|-0.081|0.723|||||Comparison of FVC, Day 1, 2 hour|||0.723|-0.081|
73950001|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.311|STANDARD_ERROR_OF_MEAN|0.1981|||TWO_SIDED|95.0|-0.079|0.701|||||Comparison of FVC, Day 1, 4 hour|||0.701|-0.079|
73950002|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.348|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|95.0|-0.064|0.76|||||Comparison of FVC, Day 1, 9 hour|||0.760|-0.064|
73950003|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.245|STANDARD_ERROR_OF_MEAN|0.241|||TWO_SIDED|95.0|-0.23|0.72|||||Comparison of FVC, Day 1, 12 hour|||0.720|-0.230|
73950004|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.162|STANDARD_ERROR_OF_MEAN|0.2063|||TWO_SIDED|95.0|-0.245|0.569|||||Comparison of FVC, Day 1, 24 hour|||0.569|-0.245|
73950005|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.535|STANDARD_ERROR_OF_MEAN|0.2907|||TWO_SIDED|95.0|-0.038|1.108|||||Comparison of FVC, Day 7, Baseline|||1.108|-0.038|
73950006|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.623|STANDARD_ERROR_OF_MEAN|0.2798|||TWO_SIDED|95.0|0.072|1.175|||||Comparison of FVC, Day 7, 1 hour|||1.175|0.072|
73950007|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.459|STANDARD_ERROR_OF_MEAN|0.2748|||TWO_SIDED|95.0|-0.083|1.0|||||Comparison of FVC, Day 7, 2 hour|||1.000|-0.083|
73950008|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.464|STANDARD_ERROR_OF_MEAN|0.2705|||TWO_SIDED|95.0|-0.069|0.997|||||Comparison of FVC, Day 7, 4 hour|||0.997|-0.069|
73950009|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.445|STANDARD_ERROR_OF_MEAN|0.2786|||TWO_SIDED|95.0|-0.104|0.994|||||Comparison of FVC, Day 7, 9 hour|||0.994|-0.104|
73978072|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Photophobia||0.141|-0.216|
73950010|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.284|STANDARD_ERROR_OF_MEAN|0.3034|||TWO_SIDED|95.0|-0.314|0.882|||||Comparison of FVC, Day 7, 12 hour|||0.882|-0.314|
73950011|NCT00453479|147433695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.384|STANDARD_ERROR_OF_MEAN|0.2766|||TWO_SIDED|95.0|-0.162|0.929|||||Comparison of FVC, Day 7, 24 hour|||0.929|-0.162|
73950012|NCT00453479|147433700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.233|STANDARD_ERROR_OF_MEAN|3.3333|||TWO_SIDED|95.0|-4.743|9.21|||||Comparison of maximum heart rate Day 1.|||9.210|-4.743|
73950013|NCT00453479|147433700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|8.0907|||TWO_SIDED|95.0|-11.2|22.664|||||Comparison of maximum heart rate Day 7.|||22.664|-11.200|
73950014|NCT00453479|147433700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.272|STANDARD_ERROR_OF_MEAN|3.239|||TWO_SIDED|95.0|-8.051|5.507|||||Comparison of maximum heart rate Day 1.|||5.507|-8.051|
73950015|NCT00453479|147433700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.988|STANDARD_ERROR_OF_MEAN|7.8616|||TWO_SIDED|95.0|-15.47|17.443|||||Comparison of maximum heart rate Day 7.|||17.443|-15.470|
73950016|NCT00453479|147433700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.734|STANDARD_ERROR_OF_MEAN|3.441|||TWO_SIDED|95.0|-4.468|9.936|||||Comparison of mean heart rate Day 1.|||9.936|-4.468|
73950017|NCT00453479|147433700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.783|STANDARD_ERROR_OF_MEAN|2.9409|||TWO_SIDED|95.0|-1.372|10.938|||||Comparison of mean heart rate Day 7.|||10.938|-1.372|
73950018|NCT00453479|147433700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.074|STANDARD_ERROR_OF_MEAN|3.3103|||TWO_SIDED|95.0|-8.003|5.854|||||Comparison of mean heart rate Day 1.|||5.854|-8.003|
73950019|NCT00453479|147433700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.569|STANDARD_ERROR_OF_MEAN|2.8291|||TWO_SIDED|95.0|-4.353|7.49|||||Comparison of mean heart rate Day 7.|||7.490|-4.353|
73950020|NCT00453479|147433704|SUPERIORITY_OR_OTHER||Ratio|1.139|STANDARD_ERROR_OF_MEAN|0.1939|||TWO_SIDED|90.0|0.811|1.601|||||SE logs is presented as standard error of mean. Comparison of GSK233705 50 µg twice daily Day 7 versus Day 1.|||1.601|0.811|
73950021|NCT00453479|147433704|SUPERIORITY_OR_OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.2057|||TWO_SIDED|90.0|0.739|1.52|||||SE logs is presented as standard error of mean. Comparison of GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.520|0.739|
73950022|NCT00453479|147433705|SUPERIORITY_OR_OTHER||Ratio|1.408|STANDARD_ERROR_OF_MEAN|0.234|||TWO_SIDED|90.0|0.934|2.122|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||2.122|0.934|
73950023|NCT00453479|147433705|SUPERIORITY_OR_OTHER||Ratio|1.19|STANDARD_ERROR_OF_MEAN|0.2482|||TWO_SIDED|90.0|0.77|1.838|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.838|0.770|
73950024|NCT00453479|147433705|SUPERIORITY_OR_OTHER||Ratio|0.979|STANDARD_ERROR_OF_MEAN|0.2269|||TWO_SIDED|90.0|0.658|1.457|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||1.457|0.658|
73950025|NCT00453479|147433705|SUPERIORITY_OR_OTHER||Ratio|1.028|STANDARD_ERROR_OF_MEAN|0.2407|||TWO_SIDED|90.0|0.674|1.568|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.568|0.674|
73950026|NCT00453479|147433707|SUPERIORITY_OR_OTHER||Ratio|2.556|STANDARD_ERROR_OF_MEAN|0.131|||TWO_SIDED|90.0|2.033|3.213|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||3.213|2.033|
73950027|NCT00453479|147433707|SUPERIORITY_OR_OTHER||Ratio|1.644|STANDARD_ERROR_OF_MEAN|0.138|||TWO_SIDED|90.0|1.29|2.095|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||2.095|1.290|
73950028|NCT01763788|147433718|SUPERIORITY||Stratified Hazard Ratio|0.656||||0.0161|TWO_SIDED|95.0|0.465|0.926|||Stratified Log Rank|||||0.926|0.465|0.0161
73950029|NCT02354859|147433732|SUPERIORITY||Difference in Proportions|5.9||||0.811|TWO_SIDED|95.0|-11.2|22.4|||Cochran-Mantel-Haenszel||The estimate is adjusted for baseline FEV1 % predicted strata (\<50% of predicted, between 50% and 70% of predicted, and \>70% of predicted).|||22.4|-11.2|0.811
73950030|NCT02354859|147433733|SUPERIORITY||Difference in Proportions-SAE inicidence|3.1||||0.807|TWO_SIDED|95.0|-10.6|16.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.|||16.6|-10.6|0.807
73978073|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.024|||||TWO_SIDED|95.0|-0.142|0.088|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Retro-orbital Pain||0.088|-0.142|
73978074|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Decrease in Activity||0.141|-0.216|
73978075|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Loss of Appetite||0.141|-0.216|
73978076|NCT02678455|147502002|SUPERIORITY||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.165|0.218|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Vomiting||0.218|-0.165|
73978077|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|76.0|88.0||||||All study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|76|
73978078|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|99.0|||||TWO_SIDED|95.0|96.0|100.0||||||All study participants seropositive to DENV-2 post TV005 Vaccination. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|96|
73870862|NCT01200368|147285895|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
73950031|NCT02354859|147433734|SUPERIORITY||Rate Ratio|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks of all participants (not per participant) in the trial was as follows: in the IV Gallium group was 486.86 and in the Placebo group was 473.57.||0.93|0.71|0.002
73978079|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm|percentage seropositive|96.0|||||TWO_SIDED|95.0|92.0|98.0||||||All study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|92|
74089325|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.62|3.57|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.57|1.62|<.0001
73870863|NCT01200368|147285895|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
73950032|NCT02354859|147433734|SUPERIORITY||Rate Ratio|0.89||||0.783|TWO_SIDED|95.0|0.39|2.03|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the IV Gallium group was 486.86 and in the Placebo group was 473.57.||2.03|0.39|0.783
73950033|NCT02354859|147433735|SUPERIORITY||Mean Difference (Final Values)|2.05||||0.479|TWO_SIDED|95.0|-3.66|7.77|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline FEV1 (liters), treatment, visit and a visit-by-visit interaction.|||7.77|-3.66|0.479
73870864|NCT01200368|147285896|SUPERIORITY_OR_OTHER||GMC ratio|1.1|||||TWO_SIDED|95.0|0.97|1.24||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.24|0.97|
73950034|NCT02354859|147433736|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.054|TWO_SIDED|95.0|-1.49|0.01|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 28 and Day 56. Mixed-effects repeated measures model includes terms for the baseline Pa density (log10 (CFU)), treatment, visit and a visit-by-visit interaction.|||0.01|-1.49|0.054
73950035|NCT02354859|147433737|SUPERIORITY||Mean Difference (Final Values)|4.23||||0.053|TWO_SIDED|95.0|-0.06|8.53|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline CFRSD-CRISS score, treatment, visit and a visit-by-visit interaction.|||8.53|-0.06|0.053
73978080|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|87.0|||||TWO_SIDED|95.0|81.0|92.0||||||All study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|81|
73978081|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
73978082|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
73870865|NCT01200368|147285896|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.77|1.06||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||1.06|0.77|
73978083|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
73870866|NCT01200368|147285897|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.87|1.1||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.10|0.87|
73870867|NCT01200368|147285897|SUPERIORITY_OR_OTHER||GMC ratio|0.92|||||TWO_SIDED|95.0|0.81|1.05||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||1.05|0.81|
73870868|NCT01200368|147285898|SUPERIORITY_OR_OTHER||GMC ratio|1.01|||||TWO_SIDED|95.0|0.88|1.15||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.15|0.88|
73870869|NCT01200368|147285898|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.85|1.19||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||1.19|0.85|
73870870|NCT01200368|147285899|SUPERIORITY_OR_OTHER||GMC ratio|0.96|||||TWO_SIDED|95.0|0.84|1.11||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.11|0.84|
73870871|NCT01200368|147285899|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.7|0.91||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||0.91|0.70|
73870872|NCT02123823|147286037|OTHER||Hazard Ratio, log|0.97||||0.9057|TWO_SIDED|95.0|0.57|1.65|||Log Rank|Two-sided log-rank test stratified for visceral involvement.|Cox proportional hazards model stratified for visceral involvement.|||1.65|0.57|0.9057
73870873|NCT02123823|147286040|OTHER||Odds Ratio, log|0.7||||0.5598|TWO_SIDED|95.0|0.2|2.32|||Regression, Logistic|Odds ratio and p-value are obtained from logistic regression model adjusted for visceral involvement at screening.|An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||2.32|0.20|0.5598
73870874|NCT02123823|147286041|OTHER||Hazard Ratio, log|1.03||||0.9146|TWO_SIDED|95.0|0.59|1.8|||Log Rank|Two-sided log-rank test stratified for visceral involvement.|Cox proportional hazards model stratified for visceral involvement.|||1.80|0.59|0.9146
73870875|NCT02123823|147286042|OTHER||Odds Ratio, log|0.7||||0.4008|TWO_SIDED|95.0|0.31|1.59|||Regression, Logistic|Odds ratio and p-value are obtained from logistic regression model adjusted for visceral involvement.|An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||1.59|0.31|0.4008
73870876|NCT03453489|147286047|OTHER|||||||0.837|||||||t-test, 2 sided|||||||0.837
73870877|NCT01635855|147286050|SUPERIORITY_OR_OTHER||One-sided binomial|8.5|||<|0.025|TWO_SIDED|95.0|3.5|13.6||Ho (null): Ps \>= 22% versus Ha (alternate): Ps \< 22% where Ps is the proportion of subjects with common severe adverse events in the post-approval study. Ho is rejected if upper limit of the 95% CI of Ps \< 22% and the one-sided p-value \<= 0.025.|One sided binomial distribution|The upper limit of the 95% two-sided CI for a proportion is equivalent to the 97.5% one-sided CI for that proportion for normal approximations.||The analysis was performed by comparing the proportion of subjects with severe common adverse events in the post-market study to that occurred in the pre-market studies. It was pre-specified in the protocol that the proportion of subjects with severe common adverse events in the pre-market studies was 22%.||13.6|3.5|< 0.025
73870878|NCT05870865|147286056|SUPERIORITY||Mean Difference (Final Values)|4.28||||0.5483|TWO_SIDED||||||Mixed Models Analysis|||||||0.5483
73870879|NCT05870865|147286056|SUPERIORITY||Mean Difference (Final Values)|-5.89||||0.4123|TWO_SIDED||||||Mixed Models Analysis|||||||0.4123
73870880|NCT05870865|147286056|SUPERIORITY||Mean Difference (Final Values)|1.66||||0.8177|TWO_SIDED||||||Mixed Models Analysis|||||||0.8177
73870881|NCT05870865|147286057|SUPERIORITY||Odds Ratio (OR)|0.66||||0.4601|TWO_SIDED||||||Fisher Exact|||||||0.4601
73978084|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
73870882|NCT05870865|147286057|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0804|TWO_SIDED||||||Fisher Exact|||||||0.0804
73870883|NCT05870865|147286057|SUPERIORITY||Odds Ratio (OR)|1.06|||>|0.9999|TWO_SIDED||||||Fisher Exact|||||||>0.9999
73870884|NCT05870865|147286058|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.2146|TWO_SIDED||||||Mixed Models Analysis|||||||0.2146
73870885|NCT05870865|147286058|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8851|TWO_SIDED||||||Mixed Models Analysis|||||||0.8851
73870886|NCT05870865|147286058|SUPERIORITY||Mean Difference (Final Values)|0.81||||0.1835|TWO_SIDED||||||Mixed Models Analysis|||||||0.1835
73870887|NCT05870865|147286059|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.7982|TWO_SIDED||||||Mixed Models Analysis|||||||0.7982
73870888|NCT05870865|147286059|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.564|TWO_SIDED||||||Mixed Models Analysis|||||||0.5640
73870889|NCT05870865|147286059|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.2939|TWO_SIDED||||||Mixed Models Analysis|||||||0.2939
73870890|NCT05870865|147286060|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.3579|TWO_SIDED||||||Mixed Models Analysis|||||||0.3579
73870891|NCT05870865|147286060|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.3466|TWO_SIDED||||||Mixed Models Analysis|||||||0.3466
73870892|NCT05870865|147286060|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.9527|TWO_SIDED||||||Mixed Models Analysis|||||||0.9527
73870893|NCT03828019|147286078|SUPERIORITY||Odds Ratio (OR)|1.86||||0.029|TWO_SIDED|95.0|1.06|3.25|||Regression, Logistic|Adjusted for the 2 stratification variables (initial prednisone dose and immunosuppression use at baseline).|Estimated parameter is the Odds Ratios (ADA/CID). Result greater than 1 indicates ADA is superior in achieving successful corticosteroid sparing|The sample size estimation: Adalimumab was estimated to be successful in 75% of patients. The overall success rate with conventional immunosuppression was estimated to be 51%. A sample size of 222 (111 per treatment group) provided 90% power to detect a difference in cumulative percent of 75% versus 51%||3.25|1.06|0.029
73978085|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adolescent study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
73950036|NCT00708305|147433738|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9762||95.0|-0.21|0.2||No adjustment was made for multiple comparisons as the primary comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments in comparison. Tests were 2-sided at 5% significance levels.||0.20|-0.21|0.9762
73950037|NCT00708305|147433739|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|0.49|||<|0.0001|TWO_SIDED|95.0|0.28|0.7||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments being compared. Tests were 2 sided at 5% significance levels.||0.70|0.28|<0.0001
73950038|NCT00708305|147433739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.44|||<|0.0001||95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.65|1.23|<0.0001
73950039|NCT00708305|147433739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49|||<|0.0001||95.0|0.28|0.7||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||0.70|0.28|<0.0001
73950040|NCT00708305|147433739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.44|||<|0.0001|TWO_SIDED|95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.65|1.23|<0.0001
73950041|NCT00708305|147433739|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.95|||<|0.0001|TWO_SIDED|95.0|0.74|1.16||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.16|0.74|<0.0001
73978086|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Adolescent study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
73978087|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
73978088|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adolescent study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
73978089|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|81.0|||||TWO_SIDED|95.0|65.0|90.0||||||Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|65|
73978090|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
73950042|NCT00708305|147433740|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.83||||0.0151|TWO_SIDED|95.0|0.12|1.72||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.72|0.12|0.0151
73978091|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
73950043|NCT00708305|147433740|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.36|||<|0.0001|TWO_SIDED|95.0|0.69|2.36||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||2.36|0.69|<0.0001
73978092|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
73870894|NCT03828019|147286079|SUPERIORITY||Odds Ratio (OR)|1.91||||0.072|TWO_SIDED|95.0|0.94|3.86|||Regression, Logistic||Odds ADA/ Odds CID|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.86|0.94|0.072
73870895|NCT03828019|147286080|SUPERIORITY||Odds Ratio (OR)|1.53||||0.3|TWO_SIDED|95.0|0.67|3.46|||Regression, Logistic||Odds ratio is ADA/CID where value greater than 1 indicates ADA is superior for corticosteroid (prednisone) discontinuation|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.46|0.67|0.30
73870896|NCT03828019|147286081|SUPERIORITY||Odds Ratio (OR)|1.85||||0.028|TWO_SIDED|95.0|1.06|3.19|||Regression, Logistic||Odds ADA/ Odds CID where value greater than 1 indicate greater corticosteroid sparing success in the ADA group|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid discontinuation between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.19|1.06|0.028
73870897|NCT03828019|147286082|SUPERIORITY||Ratio of rate of steroid (mg/day ADA/CID|0.86||||0.061|TWO_SIDED|95.0|0.73|1.01|||negative binomial model||Number greater than 1 would indicate rate of steroid use is higher in participants assigned to ADA|||1.01|0.73|0.061
73870898|NCT03828019|147286083|SUPERIORITY||Difference in mean change from BL|0.4||||0.77|TWO_SIDED|95.0|-2.3|3.1|||Mixed Models Analysis|||Mixed effects models were used with a linear link. The fixed effects included initial steroid dose and immunosuppression use at baseline. Additional visit indicators (months 1-12) and corresponding treatment by visit interaction terms. An unstructured correlation was used to model repeated measurements by eye . A person-level random intercept was added to account for between-eye correlations.||3.1|-2.3|0.77
73950044|NCT00708305|147433740|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.01|||<|0.0001|TWO_SIDED|95.0|2.06|4.05||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments. Tests were 2-sided.||4.05|2.06|<0.0001
73870899|NCT03828019|147286084|SUPERIORITY||Ratio of odds ratios|0.55||||0.028|TWO_SIDED|95.0|0.31|0.94|||Regression, Logistic||estimate is the ratio of odds ratios - OR ADA / OR CID. Value less than 1 indicates ADA is better at reducing macular edema.|Mixed effects models with a log link were used to assess treatment differences . The outcome measure was the odds ratio of having macular edema (OCT central subfield thickness \> 300 um) at 12 months compared to baseline (BL). The treatment effect was the ratio of Odds ratios (ADA/CID) at 12 months. Values less than one indicate improvement in macular edema for the ADA treatment group relative to the CID group. Decrease in subfield thickness is good||0.94|0.31|0.028
73950045|NCT00708305|147433740|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.75|||<|0.0001|TWO_SIDED|95.0|0.41|1.27||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.27|0.41|<0.0001
73978093|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|68.0|92.0||||||Young Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|68|
73978094|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Young Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
74032480|NCT04742907|147618153|SUPERIORITY||Odds Ratio (OR)|0.78||||0.518|TWO_SIDED|95.0|0.36|1.67||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.67|0.36|0.518
73950046|NCT00708305|147433740|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.1|||<|0.0001|TWO_SIDED|95.0|1.5|2.74||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||2.74|1.50|<0.0001
73978095|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Young Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
73870900|NCT03828019|147286085|SUPERIORITY||Risk Ratio (RR)|1.1||||0.76|TWO_SIDED|95.0|0.61|1.98|||negative binomial model|||||1.98|0.61|0.76
73978096|NCT02678455|147502003|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|82.0|98.0||||||Young Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|82|
74032481|NCT04742907|147618153|SUPERIORITY||Odds Ratio (OR)|1.45||||0.528|TWO_SIDED|95.0|0.46|4.53||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||4.53|0.46|0.528
73950047|NCT00708305|147433740|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.01|||<|0.0001|TWO_SIDED|95.0|0.73|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.35|0.73|<0.0001
73950048|NCT00708305|147433741|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.5545|TWO_SIDED|95.0|-0.22|0.47||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.47|-0.22|0.5545
73950049|NCT00708305|147433741|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.4||||0.0003|TWO_SIDED|95.0|0.15|0.71||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.71|0.15|0.0003
73950050|NCT00708305|147433741|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.56|0.58|<0.0001
73950051|NCT00708305|147433741|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.36|||<|0.0001|TWO_SIDED|95.0|0.15|0.68||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signal Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.68|0.15|<0.0001
73950052|NCT00708305|147433741|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.35|0.58|<0.0001
73950053|NCT00708305|147433741|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.37|||<|0.0001|TWO_SIDED|95.0|0.26|0.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.56|0.26|<0.0001
73950054|NCT00708305|147433742|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.6865|TWO_SIDED|95.0|-0.13|0.08||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.08|-0.13|0.6865
73950055|NCT00708305|147433742|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.1756|TWO_SIDED|95.0|-0.02|0.12||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.12|-0.02|0.1756
73950056|NCT00708305|147433742|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.38||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.38|0.16|<0.0001
73950057|NCT00708305|147433742|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.11||||0.0023|TWO_SIDED|95.0|0.04|0.22||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.22|0.04|0.0023
73950058|NCT00708305|147433742|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.34|||<|0.0001|TWO_SIDED|95.0|0.22|0.51||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.51|0.22|<0.0001
73950059|NCT00708305|147433742|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.18|||<|0.0001|TWO_SIDED|95.0|0.12|0.25||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.25|0.12|<0.0001
73978097|NCT02678455|147502005|SUPERIORITY||||||<|0.001||||||Comparison between experienced vs dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-1 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||<0.001
73978098|NCT02678455|147502005|SUPERIORITY|||||||1||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-2 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||1.00
74089326|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.74|3.82|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.82|1.74|<.0001
74089327|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0003|TWO_SIDED|95.0|1.47|3.7|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.70|1.47|0.0003
73950060|NCT00708305|147433743|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.0783|TWO_SIDED|95.0|-0.08|0.0||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.00|-0.08|0.0783
74089328|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0001|TWO_SIDED|95.0|1.55|3.89|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.89|1.55|0.0001
74089329|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.02||||0.031|TWO_SIDED|95.0|1.07|3.82|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.82|1.07|0.0310
74089330|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0088|TWO_SIDED|95.0|1.24|4.34|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.34|1.24|0.0088
74089331|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.49||||0.036|TWO_SIDED|95.0|1.03|2.16|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|1.03|0.0360
74089332|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0039|TWO_SIDED|95.0|1.19|2.51|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.51|1.19|0.0039
74089333|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0002|TWO_SIDED|95.0|1.43|3.13|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.13|1.43|0.0002
74089334|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.77||||0.004|TWO_SIDED|95.0|1.2|2.62|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.62|1.20|0.0040
74089335|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0175|TWO_SIDED|95.0|1.1|2.74|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.74|1.10|0.0175
74089336|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0065|TWO_SIDED|95.0|1.19|2.94|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.94|1.19|0.0065
74089337|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0796|TWO_SIDED|95.0|0.94|3.23|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|0.94|0.0796
74089338|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0718|TWO_SIDED|95.0|0.95|3.27|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.27|0.95|0.0718
73950061|NCT00708305|147433743|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0531|TWO_SIDED|95.0|0.0|0.07||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.07|0.00|0.0531
74089339|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0004|TWO_SIDED|95.0|1.36|2.96|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.36|0.0004
74089340|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.78|3.93|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.93|1.78|<.0001
73870901|NCT03828019|147286086|SUPERIORITY||Cox Proportional Hazard|0.16||||0.014|TWO_SIDED|95.0|0.04|0.7|||Regression, Cox|||. Kaplan Meier techniques and Cox proportional hazards models were used to evaluate time to event outcomes||0.70|0.04|0.014
73870902|NCT03828019|147286087|SUPERIORITY||Cox Proportional Hazard|0.89||||0.74|TWO_SIDED|95.0|0.43|1.82|||Regression, Cox|||||1.82|0.43|0.74
73870903|NCT03828019|147286088|SUPERIORITY||Odds Ratio (OR)|0.76||||0.35|TWO_SIDED|95.0|0.43|1.34|||Ratio of odds ratios||Treatment comparison is the ratio of the odds ratios for each treatment group (ADA/CID) at 12 months. Values greater than one indicate greater improvement in health for the ADA treatment group relative to the CID group.|||1.34|0.43|0.35
73870904|NCT03828019|147286089|SUPERIORITY||Mean Difference (Net)|1.39||||0.24|TWO_SIDED|95.0|-0.95|3.73|||Mixed Models Analysis|||||3.73|-0.95|0.24
73870905|NCT03828019|147286090|SUPERIORITY||Mean Difference (Net)|0.59||||0.7|TWO_SIDED|95.0|-2.43|3.61|||Mixed Models Analysis|||||3.61|-2.43|0.70
73870906|NCT03828019|147286091|SUPERIORITY||Mean Difference (Net)|1.6||||0.28|TWO_SIDED|95.0|-1.4|4.6|||Mixed Models Analysis|||||4.6|-1.4|0.28
73950062|NCT00708305|147433743|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1|||<|0.0001|TWO_SIDED|95.0|0.07|0.14||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.14|0.07|<0.0001
73950063|NCT00708305|147433743|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.0005|TWO_SIDED|95.0|0.03|0.15||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.15|0.03|0.0005
73950064|NCT00708305|147433743|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12|||<|0.0001|TWO_SIDED|95.0|0.08|0.2||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.20|0.08|<0.0001
74089341|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.11||||0.0001|TWO_SIDED|95.0|1.44|3.09|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.09|1.44|0.0001
73870907|NCT03828019|147286092|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.009|TWO_SIDED|95.0|0.07|0.67|||Regression, Cox|||||0.67|0.07|0.009
73870908|NCT00766051|147286122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|1.76|<|0.005|TWO_SIDED|95.0|5.0|11.0||The P value is not adjusted for multiple comparisons or for statistical significance|t-test, 2 sided|||The expected outcome was that infants in the intervention group would exhibit significantly less number of days to attain oral feeding.||11|5|<0.005
73870909|NCT00766051|147286123|SUPERIORITY_OR_OTHER||Slope|0.275|||<|0.01|||||||Mixed Models Analysis|This correlation is between the intervention groups' initial level of relaxation and final level of relaxation during the oral feeding period.||Pearson Correlation, 2-tailed||||< 0.01
73950065|NCT00708305|147433743|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.07|||<|0.0001|TWO_SIDED|95.0|0.04|0.1||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.10|0.04|<0.0001
73950066|NCT00708305|147433744|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.01||||0.4309|TWO_SIDED|95.0|-0.03|0.01||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.01|-0.03|0.4309
73950067|NCT00708305|147433744|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.0726|TWO_SIDED|95.0|0.0|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.04|0.00|0.0726
73950068|NCT00708305|147433744|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04|||<|0.0001|TWO_SIDED|95.0|0.03|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.06|0.03|<0.0001
73870910|NCT00766051|147286124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6|STANDARD_DEVIATION|5.2|<|0.02|ONE_SIDED|95.0||6.7|||t-test, 1 sided||An increase in this test scale score means more parent confidence.|"Parent pre-post one sided t test of parents' global confidence, measured parental confidence in feeding, handling, and interacting with their infant."||6.7||< .02
73870911|NCT00766051|147286125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8|STANDARD_DEVIATION|4.3|<|0.03|ONE_SIDED|95.0||4.54|||t-test, 1 sided||An increase in this test scale score means an increase in the parents' perception of their infants' easiness during caregiving.|Parent pre-post one sided t test on the Easiness Scale of the Mother and Baby Scales in how parents percieve their interactions (alert-responsiveness, mood) with their infant and infant sleep patterns .||4.54||< .03
73870912|NCT03401671|147286126|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.0229|||||TWO_SIDED|90.0|0.8473|1.2349||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.2349|0.8473|
73950069|NCT00708305|147433744|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0107|TWO_SIDED|95.0|0.01|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.06|0.01|0.0107
73950070|NCT00708305|147433744|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|||<|0.0001|TWO_SIDED|95.0|0.03|0.07|||Wilcoxon Signed Rank Test|No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.07|0.03|<0.0001
73950071|NCT00708305|147433744|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0012|TWO_SIDED|95.0|0.01|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.04|0.01|0.0012
73950072|NCT02771210|147433745|SUPERIORITY||Odds Ratio (OR)|1.63||||0.136|TWO_SIDED|95.0|0.87|3.08|||Regression, Logistic|||||3.08|0.87|0.136
73950073|NCT02441946|147433774|SUPERIORITY||Ratio of Geometric Means|0.19|||<|0.001|TWO_SIDED|90.0|0.13|0.28|||t-test, 1 sided|||||0.28|0.13|<0.001
73978099|NCT02678455|147502005|SUPERIORITY|||||||0.07||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-3 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||0.070
74032482|NCT04742907|147618153|SUPERIORITY||Odds Ratio (OR)|1.27||||0.689|TWO_SIDED|95.0|0.4|4.07||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||4.07|0.40|0.689
74032483|NCT04742907|147618153|SUPERIORITY||Odds Ratio (OR)|0.68||||0.653|TWO_SIDED|95.0|0.12|3.7||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||3.70|0.12|0.653
73870913|NCT03401671|147286128|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9324|||||TWO_SIDED|90.0|0.8016|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.0846|0.8016|
73950074|NCT02441946|147433774|SUPERIORITY||Ratio of Geometric Means|0.25|||<|0.001|TWO_SIDED|90.0|0.17|0.38|||t-test, 1 sided|||||0.38|0.17|<0.001
73950075|NCT00988351|147433800|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin -0.55 (mean hours of APAP arm no lower than 0.55 hours below CPAP arm)|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.4|=|0.27|TWO_SIDED|95.0|-0.35|1.26||level of significance \<0.05, Power = 0.80|t-test, 2 sided|||||1.26|-.35|= 0.27
73950076|NCT00988351|147433801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||=|0.65|TWO_SIDED|95.0|-1.3|2.1|||t-test, 2 sided|||Patients using PAP (average of \>=1/2 hour per night) at 6 weeks clinic visit||2.1|-1.3|= 0.65
73950077|NCT00988351|147433802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.71|=|0.33|TWO_SIDED|95.0|-0.73|2.1||\< 0.05 criteria for statistical significance|t-test, 2 sided|||Patients using PAP (average \>=1/2 hour per nightly use) at 6 weeks clinic visit||2.1|-0.73|=0.33
73978100|NCT02678455|147502005|SUPERIORITY|||||||1||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-4 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||1.00
73978101|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
73978102|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adult cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
74032484|NCT04742907|147618153|SUPERIORITY||Odds Ratio (OR)|1.85||||0.452|TWO_SIDED|95.0|0.37|9.25||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||9.25|0.37|0.452
74089342|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0002|TWO_SIDED|95.0|1.42|3.04|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.42|0.0002
74089343|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0003|TWO_SIDED|95.0|1.41|3.23|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|1.41|0.0003
74089344|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.52|3.46|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.46|1.52|<.0001
73950078|NCT00988351|147433803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|||=|0.49|TWO_SIDED|95.0|-1.12|2.29|||t-test, 2 sided|||Patients using PAP (average \>= 1/2 hour of nightly use) at 6 weeks clinic visit||2.29|-1.12|=0.49
73950079|NCT00988351|147433804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.51|=|0.07|TWO_SIDED|95.0|-1.92|0.09||P \< 0.05 considered statistically significant|t-test, 2 sided|||participants using PAP (average \>=1/2 hour of use) at 6 weeks clinic visit||0.09|-1.92|=0.07
73950080|NCT04844918|147433807|SUPERIORITY||LS Mean Difference|-16.1|||<|0.001|TWO_SIDED|95.0|-18.7|-13.5|||Mixed Models Analysis|||||-13.5|-18.7|<0.001
73950081|NCT04844918|147433807|SUPERIORITY||LS Mean Difference|-21.1|||<|0.001|TWO_SIDED|95.0|-23.6|-18.5|||Mixed Models Analysis|||||-18.5|-23.6|<0.001
73950082|NCT04844918|147433808|SUPERIORITY||Odds Ratio (OR)|119.65|||<|0.001|TWO_SIDED|95.0|29.06|492.67|||Mixed Models Analysis|||||492.67|29.06|<0.001
73950083|NCT04844918|147433808|SUPERIORITY||Odds Ratio (OR)|153.57|||<|0.001|TWO_SIDED|95.0|36.03|654.53|||Mixed Models Analysis|||||654.53|36.03|<0.001
73950084|NCT04844918|147433809|SUPERIORITY||Odds Ratio (OR)|24.26|||<|0.001|TWO_SIDED|95.0|8.62|68.28|||Regression, Logistic|||||68.28|8.62|<0.001
73950085|NCT04844918|147433809|SUPERIORITY||Odds Ratio (OR)|38.27|||<|0.001|TWO_SIDED|95.0|13.21|110.89|||Regression, Logistic|||||110.89|13.21|<0.001
73950086|NCT04844918|147433810|SUPERIORITY||LS Mean Difference|-15.0|||<|0.001|TWO_SIDED|95.0|-18.91|-11.09|||Mixed Models Analysis|||||-11.09|-18.91|<0.001
73950087|NCT04844918|147433810|SUPERIORITY||LS Mean Difference|-12.8|||<|0.001|TWO_SIDED|95.0|-16.56|-9.05|||Mixed Models Analysis|||||-9.05|-16.56|<0.001
73950088|NCT04844918|147433811|SUPERIORITY||LS Mean Difference|-55.76|||<|0.001|TWO_SIDED|95.0|-69.74|-41.77|||Mixed Models Analysis|||||-41.77|-69.74|<0.001
73950089|NCT04844918|147433811|SUPERIORITY||LS Mean Difference|-64.82|||<|0.001|TWO_SIDED|95.0|-78.2|-51.43|||Mixed Models Analysis|||||-51.43|-78.20|<0.001
73950090|NCT04844918|147433812|SUPERIORITY||LS Mean Difference|-40.7|||<|0.001|TWO_SIDED|95.0|-50.0|-29.7|||Mixed Models Analysis|||||-29.7|-50.0|<0.001
73950091|NCT04844918|147433812|SUPERIORITY||LS Mean Difference|-44.5|||<|0.001|TWO_SIDED|95.0|-52.7|-34.9|||Mixed Models Analysis|||||-34.9|-52.7|<0.001
73950092|NCT04844918|147433813|SUPERIORITY||LS Mean Difference|-44.4|||<|0.001|TWO_SIDED|95.0|-53.0|-35.7|||ANCOVA|||||-35.7|-53.0|<0.001
73950093|NCT04844918|147433813|SUPERIORITY||LS Mean Difference|-50.4|||<|0.001|TWO_SIDED|95.0|-58.8|-41.9|||ANCOVA|||||-41.9|-58.8|<0.001
73950094|NCT04844918|147433814|SUPERIORITY||Odds Ratio (OR)|25.42|||<|0.001|TWO_SIDED|95.0|7.25|89.14|||Regression, Logistic|||||89.14|7.25|<0.001
73950095|NCT04844918|147433814|SUPERIORITY||Odds Ratio (OR)|70.66|||<|0.001|TWO_SIDED|95.0|12.73|392.24|||Regression, Logistic|||||392.24|12.73|<0.001
73950096|NCT04844918|147433815|SUPERIORITY||Odds Ratio (OR)|9.29|||<|0.001|TWO_SIDED|95.0|2.86|30.2|||Regression, Logistic|||||30.20|2.86|<0.001
73950097|NCT04844918|147433815|SUPERIORITY||Odds Ratio (OR)|15.67|||<|0.001|TWO_SIDED|95.0|4.78|51.37|||Regression, Logistic|||||51.37|4.78|<0.001
73950098|NCT04844918|147433816|SUPERIORITY||Odds Ratio (OR)|27.5|||<|0.001|TWO_SIDED|95.0|9.35|80.88|||Regression, Logistic|||||80.88|9.35|<0.001
73950099|NCT04844918|147433816|SUPERIORITY||Odds Ratio (OR)|40.01|||<|0.001|TWO_SIDED|95.0|13.27|120.57|||Regression, Logistic|||||120.57|13.27|<0.001
73950100|NCT04844918|147433817|SUPERIORITY||Odds Ratio (OR)|185.92|||<|0.001|TWO_SIDED|95.0|46.39|745.16|||Regression, Logistic|||||745.16|46.39|<0.001
73950101|NCT04844918|147433817|SUPERIORITY||Odds Ratio (OR)|318.02|||<|0.001|TWO_SIDED|95.0|74.49|1357.79|||Regression, Logistic|||||1357.79|74.49|<0.001
73950102|NCT04844918|147433818|SUPERIORITY||Odds Ratio (OR)|100.21|||<|0.001|TWO_SIDED|95.0|18.64|538.74|||Regression, Logistic|||||538.74|18.64|<0.001
73950103|NCT04844918|147433818|SUPERIORITY||Odds Ratio (OR)|286.73|||<|0.001|TWO_SIDED|95.0|50.68|1622.06|||Regression, Logistic|||||1622.06|50.68|<0.001
73950104|NCT04844918|147433819|SUPERIORITY||LS Mean Difference|-14.5|||<|0.001|TWO_SIDED|95.0|-16.8|-12.2|||Mixed Models Analysis|||||-12.2|-16.8|<0.001
73950105|NCT04844918|147433819|SUPERIORITY||LS Mean Difference|-19.3|||<|0.001|TWO_SIDED|95.0|-21.6|-17.0|||Mixed Models Analysis|||||-17.0|-21.6|<0.001
73950106|NCT04844918|147433820|SUPERIORITY||LS Mean Difference|-5.2|||<|0.001|TWO_SIDED|95.0|-6.1|-4.4|||Mixed Models Analysis|||||-4.4|-6.1|<0.001
73950107|NCT04844918|147433820|SUPERIORITY||LS Mean Difference|-7.1|||<|0.001|TWO_SIDED|95.0|-8.0|-6.3|||Mixed Models Analysis|||||-6.3|-8.0|<0.001
73950108|NCT04844918|147433821|SUPERIORITY||LS Mean Difference|-36.1|||<|0.001|TWO_SIDED|95.0|-42.9|-29.3|||Mixed Models Analysis|||||-29.3|-42.9|<0.001
73950109|NCT04844918|147433821|SUPERIORITY||LS Mean Difference|-41.1|||<|0.001|TWO_SIDED|95.0|-47.8|-34.4|||Mixed Models Analysis|||||-34.4|-47.8|<0.001
73950110|NCT04844918|147433822|SUPERIORITY||LS Mean Difference|-27.2|||<|0.001|TWO_SIDED|95.0|-32.6|-21.9|||Mixed Models Analysis|||||-21.9|-32.6|<0.001
73950111|NCT04844918|147433822|SUPERIORITY||LS Mean Difference|-31.5|||<|0.001|TWO_SIDED|95.0|-36.7|-26.2|||Mixed Models Analysis|||||-26.2|-36.7|<0.001
73950112|NCT04844918|147433823|SUPERIORITY||LS Mean Difference|-0.1||||0.004|TWO_SIDED|95.0|-0.16|-0.03|||Mixed Models Analysis|||||-0.03|-0.16|0.004
73950113|NCT04844918|147433823|SUPERIORITY||LS Mean Difference|-0.09||||0.006|TWO_SIDED|95.0|-0.15|-0.03|||Mixed Models Analysis|||||-0.03|-0.15|0.006
73950114|NCT04844918|147433824|SUPERIORITY||Odds Ratio (OR)|28.52|||<|0.001|TWO_SIDED|95.0|4.31|188.55|||Regression, Logistic|||||188.55|4.31|<0.001
74032485|NCT04742907|147618154|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.359|TWO_SIDED|95.0|-1.8|0.6|||Mixed Models Analysis|||For Day 1, least square (LS) mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.6|-1.8|0.359
73870914|NCT03401671|147286129|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9318|||||TWO_SIDED|90.0|0.8005|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.0846|0.8005|
73950115|NCT04844918|147433824|SUPERIORITY||Odds Ratio (OR)|57.73|||<|0.001|TWO_SIDED|95.0|8.68|383.88|||Regression, Logistic|||||383.88|8.68|<0.001
73950116|NCT04844918|147433825|SUPERIORITY||LS Mean Difference|-11.4|||<|0.001|TWO_SIDED|95.0|-13.8|-9.0|||Mixed Models Analysis|||||-9.0|-13.8|<0.001
73950117|NCT04844918|147433825|SUPERIORITY||LS Mean Difference|-15.3|||<|0.001|TWO_SIDED|95.0|-17.7|-13.0|||Mixed Models Analysis|||||-13.0|-17.7|<0.001
73950118|NCT04844918|147433826|SUPERIORITY||LS Mean Difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.77|-0.53|||Mixed Models Analysis|||||-0.53|-0.77|<0.001
73950119|NCT04844918|147433826|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.77|-0.55|||Mixed Models Analysis|||||-0.55|-0.77|<0.001
73950120|NCT04844918|147433827|SUPERIORITY||LS Mean Difference|-3.91|||||TWO_SIDED|95.0|-5.74|-2.08||||||||-2.08|-5.74|
73950121|NCT04844918|147433827|SUPERIORITY||LS Mean Difference|-4.55|||||TWO_SIDED|95.0|-6.29|-2.81||||||||-2.81|-6.29|
73950122|NCT04844918|147433828|SUPERIORITY||LS Mean Difference|-13.2|||<|0.001|TWO_SIDED|95.0|-17.0|-9.3|||Mixed Models Analysis|||||-9.3|-17.0|<0.001
73950123|NCT04844918|147433828|SUPERIORITY||LS Mean Difference|-13.9|||<|0.001|TWO_SIDED|95.0|-17.7|-10.1|||Mixed Models Analysis|||||-10.1|-17.7|<0.001
73950124|NCT04844918|147433829|SUPERIORITY||LS Mean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-9.3|-3.4|||Mixed Models Analysis|||||-3.4|-9.3|<0.001
73950125|NCT04844918|147433829|SUPERIORITY||LS Mean Difference|-6.8|||<|0.001|TWO_SIDED|95.0|-9.7|-3.9|||Mixed Models Analysis|||||-3.9|-9.7|<0.001
73950126|NCT04844918|147433830|SUPERIORITY||LS Mean Difference|1.3||||0.022|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||||2.3|0.2|0.022
73950127|NCT04844918|147433830|SUPERIORITY||LS Mean Difference|2.1|||<|0.001|TWO_SIDED|95.0|1.1|3.2|||ANCOVA|||||3.2|1.1|<0.001
73950128|NCT04844918|147433831|SUPERIORITY||LS Mean Difference|13.0|||<|0.001|TWO_SIDED|95.0|7.4|18.7|||ANCOVA|||||18.7|7.4|<0.001
73950129|NCT04844918|147433831|SUPERIORITY||LS Mean Difference|10.8|||<|0.001|TWO_SIDED|95.0|5.4|16.3|||ANCOVA|||||16.3|5.4|<0.001
73950130|NCT04844918|147433832|SUPERIORITY||LS Mean Difference|0.03||||0.099|TWO_SIDED|95.0|0.0|0.06|||ANCOVA|||||0.06|0.00|0.099
73950131|NCT04844918|147433832|SUPERIORITY||LS Mean Difference|0.02||||0.236|TWO_SIDED|95.0|-0.01|0.05|||ANCOVA|||||0.05|-0.01|0.236
73950132|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.23|2.69||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 5 min||2.69|-1.23|
73950133|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-1.32|2.29||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 10 min||2.29|-1.32|
73950134|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.76|2.08||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 20 min||2.08|-1.76|
73950135|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.09|2.35||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 30 min||2.35|-1.09|
73950136|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-1.88|2.25||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1 hour||2.25|-1.88|
73950137|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.47|2.37||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1.5 hours||2.37|-1.47|
73950138|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.99|1.92||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 2 hours||1.92|-1.99|
73950139|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|2.39|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|0.35|4.43||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 3 hours||4.43|0.35|
73950140|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-1.57|2.12||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 4 hours||2.12|-1.57|
73870915|NCT04090242|147286146|OTHER||Mean Difference (Final Values)|-0.16||||0.392|TWO_SIDED|95.0|-0.53|0.21||The p value is for the comparison between interventional and control group on change of DES score between baseline and end of study.|Mixed Models Analysis|||With assumptions made in statistical analysis plan, a sample size of 43 subjects per arm had \>80% power to detect a significant difference between the two arms (based on a 2-sided t-test, 95% CI for DES difference between groups). Adding a 10% buffer, planned enrollment was 96 subjects. However, enrollment ended early with about 25 subjects in each arm (56 subjects total). Thus, power decreased to 56%. The study was not sufficiently powered under these conditions.||0.21|-0.53|0.392
73950141|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-1.15|3.37||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 8 hours||3.37|-1.15|
74032486|NCT04742907|147618154|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.907|TWO_SIDED|95.0|-1.3|1.2|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.2|-1.3|0.907
73950142|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|-1.52|2.14||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 24 hours||2.14|-1.52|
73950143|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|4.81|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|2.84|6.78||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 5 min||6.78|2.84|
73950144|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.93|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|0.12|3.73||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 10 min||3.73|0.12|
73950145|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.71|2.12||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 20 min||2.12|-1.71|
73950146|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.29|2.15||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 30 min||2.15|-1.29|
73950147|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-1.6|2.53||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1 hour||2.53|-1.60|
73950148|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-3.03|0.81||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1.5 hours||0.81|-3.03|
73950149|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-3.13|0.78||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 2 hours||0.78|-3.13|
73950150|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|-3.36|0.71||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 3 hours||0.71|-3.36|
73950151|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-2.69|1.0||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 4 hours||1.00|-2.69|
73950152|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-4.19|0.32||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 8 hours||0.32|-4.19|
73950153|NCT03657264|147433858|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-1.62|2.04||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 24 hours||2.04|-1.62|
73950154|NCT03657264|147433859|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|4.62|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|2.58|6.66||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 1 hour||6.66|2.58|
73950155|NCT03657264|147433859|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|9.4|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|7.14|11.66||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 1.5 hours||11.66|7.14|
73870916|NCT00195663|147286160|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment, the second primary analysis of the modified Total Sharp Score was to be performed.|Chi-squared, Corrected|||The study was powered to demonstrate the superiority of adalimumab + MTX combination therapy vs. MTX monotherapy in the proportion of subjects who achieved an ACR50 response at 52 weeks. Power calculations were based on 250 subjects in each group using a chi-squared test with a continuity correction and an alpha = 0.05 significance level. With 250 subjects in each group, a difference of 0.13 in response rates could be detected with 80% power.||||<0.001
73870917|NCT00195663|147286161|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment on the ACR50 response, the second primary analysis of modified TSS would be performed.||||<0.001
73870918|NCT00195663|147286162|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73870919|NCT00195663|147286163|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
73870920|NCT00195663|147286164|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
73870921|NCT00195663|147286165|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
73950156|NCT03657264|147433859|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.55|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|7.92|13.17||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 2 hours||13.17|7.92|
73950157|NCT03657264|147433859|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.33|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|90.0|7.7|12.95||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 3 hours||12.95|7.70|
73950158|NCT03657264|147433859|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.65|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|8.05|13.25||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 4 hours||13.25|8.05|
73978103|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
73950159|NCT00924469|147433861|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.61||||0.0216||90.0|0.429|0.865||Test for no difference of natural log transformed values between treatments was calculated using two-way analysis of variance (ANOVA) adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 12||0.865|0.429|0.0216
73950160|NCT00924469|147433862|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.43||||0.1423||90.0|0.956|2.145||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 24||2.145|0.956|0.1423
73950161|NCT00924469|147433862|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.82||||0.6639||90.0|0.386|1.746||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 24||1.746|0.386|0.6639
73950162|NCT00924469|147433863|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.32|||<|0.0001||90.0|0.239|0.418||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for androstenedione concentration at Week 12||0.418|0.239|<0.0001
73950163|NCT00924469|147433863|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.13||||0.5061||90.0|0.828|1.554||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for androstenedione concentration at Week 24||1.554|0.828|0.5061
73978104|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
73978105|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
74089345|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.09||||0.0113|TWO_SIDED|95.0|1.18|3.68|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.68|1.18|0.0113
74089346|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.19||||0.0064|TWO_SIDED|95.0|1.25|3.85|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.85|1.25|0.0064
73870922|NCT00195663|147286166|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
73870923|NCT00195663|147286167|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
73870924|NCT00195663|147286168|SUPERIORITY_OR_OTHER|||||||0.5402||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5402
73870925|NCT01100775|147286228|SUPERIORITY|||||||0.898|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Hits between Galantamine and Placebo Arms||||0.898
73870926|NCT01100775|147286228|SUPERIORITY|||||||0.701|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms between Galantamine and Placebo Arms||||0.701
74032487|NCT04742907|147618154|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.856|TWO_SIDED|95.0|-1.3|1.6|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.6|-1.3|0.856
73870927|NCT01100775|147286228|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Galantamine and Placebo Arms||||0.16
73870928|NCT01100775|147286228|SUPERIORITY|||||||0.701|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms between Galantamine and Placebo Arms||||0.701
73870929|NCT01100775|147286229|SUPERIORITY|||||||0.161|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Reaction Time between Galantamine and Placebo Arms||||0.161
73870930|NCT01100775|147286229|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarm Reaction Time between Galantamine and Placebo Arms||||0.028
73870931|NCT01100775|147286229|SUPERIORITY|||||||0.899|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Reaction Time between Galantamine and Placebo Arms||||0.899
73870932|NCT01100775|147286229|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms Reaction Time between Galantamine and Placebo Arms||||0.521
73870933|NCT01100775|147286230|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean total amount offered during the trust game between the galantamine and placebo groups||||0.67
73870934|NCT01100775|147286231|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean correct responses between galantamine and placebo||||0.32
73870935|NCT01100775|147286232|SUPERIORITY|||||||0.659|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 1 between galantamine and placebo||||0.659
73950164|NCT00924469|147433863|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.03|||<|0.0001||90.0|0.017|0.05||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 3 for DHEA concentration at Week 12||0.050|0.017|<0.0001
73950165|NCT00924469|147433863|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.79||||0.5767||90.0|0.398|1.581||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 4 for DHEA concentration at Week 24||1.581|0.398|0.5767
73870936|NCT01100775|147286232|SUPERIORITY|||||||0.541|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 2 between galantamine and placebo||||0.541
73870937|NCT01100775|147286232|SUPERIORITY|||||||0.838|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 3 between galantamine and placebo||||0.838
73950166|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.14|||<|0.0001||90.0|0.097|0.207||Test for no difference of natural log transformed values between treatments was calculated using analysis of covariance (ANCOVA) adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 1 for serum testosterone concentration at Week 12||0.207|0.097|<0.0001
73978106|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
73978107|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
73978108|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adult cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
74032488|NCT04742907|147618154|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.18|TWO_SIDED|95.0|-2.7|0.5|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.5|-2.7|0.180
73870938|NCT01100775|147286233|SUPERIORITY|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||A comparison the mean correct responses between galantamine and placebo||||0.548
73870939|NCT01100775|147286234|SUPERIORITY|||||||0.871|||||||Wilcoxon (Mann-Whitney)|||||||0.871
73870940|NCT01100775|147286235|SUPERIORITY|||||||0.626|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Affect between galantamine and placebo||||0.626
73870941|NCT01100775|147286235|SUPERIORITY|||||||0.234|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Social Skill between galantamine and placebo||||0.234
73870942|NCT01100775|147286236|SUPERIORITY|||||||0.797|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total Responses between galantamine and placebo||||0.797
73870943|NCT01100775|147286236|SUPERIORITY|||||||0.669|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total Hits between galantamine and placebo||||0.669
73870944|NCT01100775|147286236|SUPERIORITY|||||||0.668|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total False Alarms between galantamine and placebo||||0.668
73870945|NCT02815644|147286237|SUPERIORITY_OR_OTHER||T/R ratio|55.69|STANDARD_ERROR_OF_MEAN|1.087|||TWO_SIDED|90.0|48.22|64.33|||||Standard Error of the mean is actually geometric Standard Error of the mean.|"Relative bioavailability of linagliptin after food intake compared to while in the fasting state was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||64.33|48.22|
73950167|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.84||||0.4364||90.0|0.571|1.225||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 2 for serum testosterone concentration at Week 24||1.225|0.571|0.4364
73950168|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.75||||0.1515||90.0|0.54|1.044||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 3 for serum DHT concentration at Week 12||1.044|0.540|0.1515
73950169|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.84||||0.3965||90.0|0.589|1.188||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 4 for serum DHT concentration at Week 24||1.188|0.589|0.3965
73950170|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.42||||0.0003||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 5 for serum Androsterone concentration at Week 12||0.615|0.290|0.0003
73950171|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.22||||0.2494||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 6 for serum androsterone concentration at Week 24||1.625|0.916|0.2494
73950172|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.04|||<|0.0001||90.0|0.023|0.073||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 7 for serum DHEA concentration at Week 12||0.073|0.023|<0.0001
73950173|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.24||||0.5144||90.0|0.717|2.137||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 8 for serum DHEA concentration at Week 24||2.137|0.717|0.5144
73950174|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.1|||<|0.0001||90.0|0.055|0.189||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 9 for serum DHEA-glucuronide concentration at Week 12||0.189|0.055|<0.0001
73950175|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.55||||0.1329||90.0|0.286|1.06||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 10 for serum DHEA-glucuronide concentration at Week 24||1.060|0.286|0.1329
73950176|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.01|||<|0.0001||90.0|0.008|0.028||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 11 for serum DHEA-sulfate concentration at Week 12||0.028|0.008|<0.0001
73950177|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.2||||0.7061||90.0|0.53|2.73|||ANCOVA|||Statistical Analysis 12 for serum DHEA-sulfate concentration at Week 24||2.730|0.530|0.7061
73950178|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.42|||<|0.0001||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 13 for serum delta-4-androstenedione concentration at Week 12||0.615|0.290|<0.0001
73950179|NCT00924469|147433864|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.22||||0.2673||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 14 for serum delta-4-androstenedione concentration at Week 24||1.625|0.916|0.2673
73950180|NCT00924469|147433865|SUPERIORITY_OR_OTHER||Relative risk|25.533|||<|0.0001||90.0|4.989|130.68|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for PSA response at Week 12||130.680|4.989|<0.0001
73950181|NCT00924469|147433865|SUPERIORITY_OR_OTHER||Relative risk|1.131||||0.2319||90.0|0.956|1.337|||Cochran-Mantel-Haenszel|||Statistical Analysis 2 for PSA response at Week 24||1.337|0.956|0.2319
73950182|NCT00924469|147433866|SUPERIORITY_OR_OTHER||Relative risk|2.744||||0.3427||90.0|1.018|5.015|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for CR at Week 24||5.015|1.018|0.3427
73950183|NCT00924469|147433869|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.17|||<|0.0001||90.0|0.098|0.289||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 12||0.289|0.098|<0.0001
73950184|NCT01651936|147433876|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-0.52||||0.308|TWO_SIDED|95.0|-1.54|0.5|||Constrained Longitudinal Data Analysis|||||0.50|-1.54|0.308
73950185|NCT01651936|147433877|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|-0.26||||0.91|TWO_SIDED|95.0|-23.52|23.01|||Cochran-Mantel-Haenszel|||||23.01|-23.52|0.91
73950186|NCT01651936|147433879|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|8.46||||0.468|TWO_SIDED|95.0|-10.4|27.32|||Cochran-Mantel-Haenszel|||||27.32|-10.40|0.468
73950187|NCT01651936|147433881|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-0.41||||0.038|TWO_SIDED|95.0|-0.79|-0.02|||Constrained Longitudinal Data Analysis|||||-0.02|-0.79|0.038
73950188|NCT00305864|147433976|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Log Rank|One-sided||A one-sided one-sample log-rank test at significance level of 0.10 was predicted to have 85% power to detect a survival difference against the historical control (13.7 vs. 18.5 months) with 60 deaths.||||0.27
73950189|NCT03881059|147433988|SUPERIORITY||Slope Coefficient of Dose|0.11|||<|0.001|TWO_SIDED|95.0|0.05|0.17|||Regression, Logistic|||||0.17|0.05|<0.001
73950190|NCT02065570|147434032|SUPERIORITY||Adjusted risk difference|0.3||||0.939|TWO_SIDED|95.0|-8.1|8.8||Adjusted for previous infliximab use (or prior anti-tumor necrosis factor (TNF) use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.8|-8.1|0.939
73978109|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adult cohort: percent seropositive to DENV-2 at stud day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
74032489|NCT04742907|147618154|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.814|TWO_SIDED|95.0|-1.9|2.4|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.4|-1.9|0.814
73870946|NCT02815644|147286238|SUPERIORITY_OR_OTHER||T/R ratio|74.89|STANDARD_ERROR_OF_MEAN|1.073|||TWO_SIDED|90.0|66.27|84.64|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||84.64|66.27|
73870947|NCT02815644|147286239|SUPERIORITY_OR_OTHER||T/R ratio|82.19|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||86.18|78.38|
73870948|NCT02815644|147286240|SUPERIORITY_OR_OTHER||T/R ratio|85.99|STANDARD_ERROR_OF_MEAN|1.018|||TWO_SIDED|90.0|83.38|88.68|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||88.68|83.38|
73870949|NCT02815644|147286241|SUPERIORITY_OR_OTHER||T/R ratio|88.13|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|90.0|80.89|96.03|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||96.03|80.89|
74032490|NCT04742907|147618154|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.409|TWO_SIDED|95.0|-3.2|1.3|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.3|-3.2|0.409
73870950|NCT02815644|147286242|SUPERIORITY_OR_OTHER||T/R ratio|86.33|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|90.0|83.61|89.13|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||89.13|83.61|
73950191|NCT02065570|147434033|SUPERIORITY||Adjusted risk difference|3.2||||0.462|TWO_SIDED|95.0|-5.3|11.7||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.7|-5.3|0.462
73950192|NCT02065570|147434035|SUPERIORITY||Adjusted risk difference|4.6||||0.269|TWO_SIDED|95.0|-3.6|12.8||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||12.8|-3.6|0.269
73978110|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
74032491|NCT04742907|147618155|SUPERIORITY||Odds Ratio (OR)|0.8||||0.43|TWO_SIDED|95.0|0.46|1.4||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.40|0.46|0.430
73950193|NCT02065570|147434036|SUPERIORITY||Adjusted risk difference|1.8||||0.61|TWO_SIDED|95.0|-5.1|8.7||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.7|-5.1|0.610
73950194|NCT02065570|147434037|SUPERIORITY||Adjusted risk difference|11.2||||0.008|TWO_SIDED|95.0|2.9|19.6||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||19.6|2.9|0.008
73950195|NCT02065570|147434038|SUPERIORITY||Adjusted risk difference|6.0||||0.336|TWO_SIDED|95.0|-6.2|18.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||18.2|-6.2|0.336
73950196|NCT02065570|147434039|SUPERIORITY||Adjusted risk difference|1.5||||0.694|TWO_SIDED|95.0|-6.1|9.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||9.1|-6.1|0.694
73950197|NCT02065570|147434040|SUPERIORITY||LS Mean of Difference|6.8||||0.946|TWO_SIDED|95.0|-192.3|205.9|||Cochran-Mantel-Haenszel|||||205.9|-192.3|0.946
73950198|NCT02065570|147434041|SUPERIORITY||Adjusted risk difference|4.0||||0.293|TWO_SIDED|95.0|-3.5|11.5||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.5|-3.5|0.293
73950199|NCT02065570|147434042|SUPERIORITY||Adjusted risk difference|3.0||||0.304|TWO_SIDED|95.0|-2.7|8.6||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.6|-2.7|0.304
73950200|NCT02065570|147434043|SUPERIORITY||Adjusted risk difference|4.2||||0.092|TWO_SIDED|95.0|-0.7|9.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||9.1|-0.7|0.092
73950201|NCT02065570|147434044|SUPERIORITY||Adjusted risk difference|3.6||||0.278|TWO_SIDED|95.0|-2.9|10.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||10.2|-2.9|0.278
73978111|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-2 at study day 180. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
73978112|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
73978113|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
73950202|NCT02065570|147434045|SUPERIORITY||Adjusted risk difference|3.7||||0.353|TWO_SIDED|95.0|-4.1|11.5||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.5|-4.1|0.353
73978114|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
73978115|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adult cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
73978116|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adult cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
73978117|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
74089347|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.58||||0.02|TWO_SIDED|95.0|1.07|2.31|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.07|0.0200
73870951|NCT02815644|147286243|SUPERIORITY_OR_OTHER||T/R Ratio|82.19|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||86.18|78.38|
73870952|NCT03364309|147286248|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.0001|TWO_SIDED|95.0|33.57|99.99|||Regression, Logistic|||||99.99|33.57|<0.0001
73870953|NCT03364309|147286248|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|52.49|99.99|||Regression, Logistic|||||99.99|52.49|<0.001
73870954|NCT03364309|147286249|SUPERIORITY||Odds Ratio (OR)|79.95|||<|0.001|TWO_SIDED|95.0|32.76|99.99|||Regression, Logistic|||||99.99|32.76|<0.001
73870955|NCT03364309|147286249|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|64.87|99.99|||Regression, Logistic|||||99.99|64.87|<0.001
73870956|NCT03364309|147286251|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|31.88|99.99|||Regression, Logistic|||||99.99|31.88|<0.001
73870957|NCT03364309|147286251|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|46.96|99.99|||Regression, Logistic|||||99.99|46.96|<0.001
73950203|NCT02065570|147434046|SUPERIORITY||Adjusted risk difference|8.9||||0.015|TWO_SIDED|95.0|1.8|16.0||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||16.0|1.8|0.015
73950204|NCT02065570|147434047|SUPERIORITY||Adjusted risk difference|3.4||||0.394|TWO_SIDED|95.0|-4.4|11.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.1|-4.4|0.394
73870958|NCT03364309|147286253|SUPERIORITY||Odds Ratio (OR)|37.24|||<|0.001|TWO_SIDED|95.0|13.68|99.99|||Regression, Logistic|||||99.99|13.68|<0.001
73870959|NCT03364309|147286253|SUPERIORITY||Odds Ratio (OR)|41.38|||<|0.001|TWO_SIDED|95.0|15.09|99.99|||Regression, Logistic|||||99.99|15.09|<0.001
73870960|NCT03364309|147286254|SUPERIORITY||LSMean Difference|-9.52|STANDARD_ERROR_OF_MEAN|0.604|<|0.001|TWO_SIDED|95.0|-10.71|-8.33|||Mixed Models Analysis|||||-8.33|-10.71|<0.001
73950205|NCT02065570|147434048|SUPERIORITY||Adjusted risk difference|3.6||||0.349|TWO_SIDED|95.0|-4.0|11.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)|||11.2|-4.0|0.349
73978118|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
73978119|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
73978120|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
73870961|NCT03364309|147286254|SUPERIORITY||LSMean Difference|-9.78|STANDARD_ERROR_OF_MEAN|0.603|<|0.001|TWO_SIDED|95.0|-10.96|-8.59|||Mixed Models Analysis|||||-8.59|-10.96|<0.001
73870962|NCT03364309|147286255|SUPERIORITY||LSMean Difference|-10.09|STANDARD_ERROR_OF_MEAN|1.673|<|0.001|TWO_SIDED|95.0|-13.38|-6.79|||Mixed Models Analysis|||||-6.79|-13.38|<0.001
73870963|NCT03364309|147286255|SUPERIORITY||LSMean Difference|-8.81|STANDARD_ERROR_OF_MEAN|1.677|<|0.001|TWO_SIDED|95.0|-12.11|-5.51|||Mixed Models Analysis|||||-5.51|-12.11|<0.001
73870964|NCT03364309|147286256|SUPERIORITY||LSMean Difference|-34.96|STANDARD_ERROR_OF_MEAN|2.023|<|0.001|TWO_SIDED|95.0|-38.94|-30.98|||Mixed Models Analysis|||||-30.98|-38.94|<0.001
73870965|NCT03364309|147286256|SUPERIORITY||LSMean Difference|-36.34|STANDARD_ERROR_OF_MEAN|2.018|<|0.001|TWO_SIDED|95.0|-40.3|-32.37|||Mixed Models Analysis|||||-32.37|-40.30|<0.001
73870966|NCT03364309|147286257|SUPERIORITY||LSMean Difference|-16.74|STANDARD_ERROR_OF_MEAN|0.957|<|0.001|TWO_SIDED|95.0|-18.62|-14.86|||Mixed Models Analysis|||||-14.86|-18.62|<0.001
73870967|NCT03364309|147286257|SUPERIORITY||LSMean Difference|-17.93|STANDARD_ERROR_OF_MEAN|0.954|<|0.001|TWO_SIDED|95.0|-19.8|-16.05|||Mixed Models Analysis|||||-16.05|-19.80|<0.001
73870968|NCT03364309|147286258|SUPERIORITY||LSMean Difference|6.228|STANDARD_ERROR_OF_MEAN|0.6681|<|0.001|TWO_SIDED|95.0|4.915|7.541|||Mixed Models Analysis|||||7.541|4.915|<0.001
73870969|NCT03364309|147286258|SUPERIORITY||LSMean Difference|6.536|STANDARD_ERROR_OF_MEAN|0.6668|<|0.001|TWO_SIDED|95.0|5.225|7.847|||Mixed Models Analysis|||||7.847|5.225|<0.001
73870970|NCT03364309|147286259|SUPERIORITY||LSMean Difference|5.193|STANDARD_ERROR_OF_MEAN|0.9489|<|0.001|TWO_SIDED|95.0|3.328|7.058|||Mixed Models Analysis|||||7.058|3.328|<0.001
73870971|NCT03364309|147286259|SUPERIORITY||LSMean Difference|5.362|STANDARD_ERROR_OF_MEAN|0.946|<|0.001|TWO_SIDED|95.0|3.503|7.222|||Mixed Models Analysis|||||7.222|3.503|<0.001
73870972|NCT03364309|147286260|SUPERIORITY||LSMean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-2.9|-2.4|||Mixed Models Analysis|||||-2.4|-2.9|<0.001
73870973|NCT03364309|147286260|SUPERIORITY||LSMean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-2.9|-2.3|||Mixed Models Analysis|||||-2.3|-2.9|<0.001
73870974|NCT03364309|147286261|SUPERIORITY||LSMean Difference|-3.35|STANDARD_ERROR_OF_MEAN|1.11||0.003|TWO_SIDED|95.0|-5.56|-1.15|||Mixed Models Analysis|||||-1.15|-5.56|0.003
73870975|NCT03364309|147286261|SUPERIORITY||LSMean Difference|-4.79|STANDARD_ERROR_OF_MEAN|1.064|<|0.001|TWO_SIDED|95.0|-6.9|-2.67|||Mixed Models Analysis|||||-2.67|-6.90|<0.001
73950206|NCT02065570|147434049|SUPERIORITY||Adjusted risk difference|7.6||||0.054|TWO_SIDED|95.0|-0.1|15.3||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)|||15.3|-0.1|0.054
73950207|NCT02293837|147434084|SUPERIORITY|||||||0.277||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52; Primary imputation method used for missing Week 52 mAUC.||||0.277
73950208|NCT02293837|147434085|SUPERIORITY|||||||0.499||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.499
73950209|NCT02293837|147434085|SUPERIORITY|||||||0.267||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.267
73950210|NCT02293837|147434085|SUPERIORITY|||||||0.226||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.226
73950211|NCT02293837|147434085|SUPERIORITY|||||||0.758||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.758
73978121|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
73978122|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|20.0|||||TWO_SIDED|95.0|10.0|36.0||||||Adult cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||36|10|
73950212|NCT02293837|147434085|SUPERIORITY|||||||0.341||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.341
73978123|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|77.0|||||TWO_SIDED|95.0|61.0|88.0||||||Adult cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|61|
73978124|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
73978125|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adult cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
73950213|NCT02293837|147434085|SUPERIORITY|||||||0.969||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.969
73978126|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
73978127|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|60.0|||||TWO_SIDED|95.0|44.0|74.0||||||Adult cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||74|44|
73950214|NCT02293837|147434085|SUPERIORITY|||||||0.689||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.689
73950215|NCT02293837|147434085|SUPERIORITY|||||||0.4||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.400
73978128|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|63.0|||||TWO_SIDED|95.0|46.0|77.0||||||Adult cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||77|46|
73978129|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|26.0|||||TWO_SIDED|95.0|14.0|42.0||||||Adolescent cohort: percent seropositive to DENV-1 a study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||42|14|
74032492|NCT04742907|147618155|SUPERIORITY||Odds Ratio (OR)|1.1||||0.739|TWO_SIDED|95.0|0.62|1.96||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.96|0.62|0.739
73950216|NCT02293837|147434085|SUPERIORITY|||||||0.969||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.969
73950217|NCT02293837|147434086|SUPERIORITY|||||||0.679||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.679
73950218|NCT02293837|147434086|SUPERIORITY|||||||0.373||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.373
73950219|NCT02293837|147434086|SUPERIORITY|||||||0.395||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.395
73870976|NCT03364309|147286262|SUPERIORITY||LSMean Difference|-27.4|STANDARD_ERROR_OF_MEAN|11.07||0.022|TWO_SIDED|95.0|-50.5|-4.3|||Mixed Models Analysis|||||-4.3|-50.5|0.022
73950220|NCT02293837|147434087|SUPERIORITY|||||||0.176||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.176
73978130|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
73978131|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
73978132|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
73978133|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
73978134|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|43.0|||||TWO_SIDED|95.0|28.0|59.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||59|28|
73978135|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|46.0|||||TWO_SIDED|95.0|30.0|62.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||62|30|
73978136|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|34.0|||||TWO_SIDED|95.0|21.0|51.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||51|21|
73978137|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
73870977|NCT03364309|147286262|SUPERIORITY||LSMean Difference|-25.2|STANDARD_ERROR_OF_MEAN|10.87||0.031|TWO_SIDED|95.0|-47.8|-2.5|||Mixed Models Analysis|||||-2.5|-47.8|0.031
73950221|NCT02293837|147434087|SUPERIORITY|||||||0.285||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.285
73978138|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
73978139|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
73978140|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|85.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
73978141|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
73978142|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
73978143|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|37.0|||||TWO_SIDED|95.0|23.0|54.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||54|23|
73870978|NCT03543137|147286272|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 - 1.25 range.|Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.88|1.02|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)|||1.02|0.88|
73870979|NCT03543137|147286273|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-inf fell completely within the range.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.88|1.01|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.01|0.88|
73870980|NCT03543137|147286278|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the range.|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.9|1.04|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.04|0.90|
73950222|NCT02293837|147434087|SUPERIORITY|||||||0.435||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.435
73870981|NCT01052077|147286279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18||||0.1416|TWO_SIDED|95.0|-2.75|0.39||ANCOVA model, with treatment and study center as main effects and Week 8 value as convariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.39|-2.75|0.1416
73950223|NCT02293837|147434087|SUPERIORITY|||||||0.931||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.931
73950224|NCT02293837|147434087|SUPERIORITY|||||||0.28||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.280
73950225|NCT02293837|147434087|SUPERIORITY|||||||0.985||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.985
73950226|NCT02293837|147434088|SUPERIORITY|||||||0.762||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.762
73950227|NCT02293837|147434088|SUPERIORITY|||||||0.64||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 52||||0.640
73950228|NCT02293837|147434088|SUPERIORITY|||||||0.145||||||P-value comes from an analysis of covariance with outcome variable of change in avg insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.145
73950229|NCT02293837|147434088|SUPERIORITY|||||||0.033||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.033
73950230|NCT02293837|147434088|SUPERIORITY|||||||0.591||||||P-value comes from an analysis of covariance with outcome variable of change in avg insulin use per kg from baseline and covariates of treatment, baseline avg insulin use per kg, and age.|ANCOVA|||Week 52||||0.591
73950231|NCT02293837|147434088|SUPERIORITY|||||||0.81||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.810
73950232|NCT02293837|147434088|SUPERIORITY|||||||0.178||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.178
73950233|NCT02293837|147434088|SUPERIORITY|||||||0.43||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 52||||0.430
73950234|NCT02293837|147434088|SUPERIORITY|||||||0.149||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.149
73950235|NCT02293837|147434089|SUPERIORITY|||||||0.103||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.103
73950236|NCT02293837|147434089|SUPERIORITY|||||||0.452||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.452
73950237|NCT02293837|147434089|SUPERIORITY|||||||0.091||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.091
73950238|NCT02293837|147434090|SUPERIORITY|||||||0.154||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.154
73950239|NCT02293837|147434090|SUPERIORITY|||||||0.193||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.193
73950240|NCT02293837|147434090|SUPERIORITY|||||||0.397||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.397
73950241|NCT02293837|147434090|SUPERIORITY|||||||0.125||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.125
73950242|NCT02293837|147434090|SUPERIORITY|||||||0.705||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.705
73870982|NCT01052077|147286280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.3778|TWO_SIDED|95.0|-0.69|0.26||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.26|-0.69|0.3778
74032493|NCT04742907|147618155|SUPERIORITY||Odds Ratio (OR)|0.54||||0.13|TWO_SIDED|95.0|0.25|1.2||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.20|0.25|0.130
73870983|NCT01052077|147286281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0162|TWO_SIDED|95.0|-2.38|-0.24||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||-0.24|-2.38|0.0162
73870984|NCT01052077|147286281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0031|TWO_SIDED|95.0|-3.15|-0.65||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||-0.65|-3.15|0.0031
73950243|NCT02293837|147434090|SUPERIORITY|||||||0.378||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.378
73950244|NCT02293837|147434090|SUPERIORITY|||||||0.035||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.035
73950245|NCT02293837|147434090|SUPERIORITY|||||||0.262||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.262
73950246|NCT02293837|147434090|SUPERIORITY|||||||0.338||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.338
73950247|NCT02293837|147434091|SUPERIORITY|||||||0.493||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.493
73950248|NCT02293837|147434091|SUPERIORITY|||||||0.659||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.659
73950249|NCT02293837|147434091|SUPERIORITY|||||||0.407||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.407
73950250|NCT02293837|147434092|SUPERIORITY|||||||0.634||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.634
73950251|NCT02293837|147434092|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||1.000
73950252|NCT02293837|147434092|SUPERIORITY|||||||0.329||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.329
73950253|NCT02293837|147434092|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||1.000
73950254|NCT02293837|147434092|SUPERIORITY|||||||0.847||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.847
73950255|NCT02293837|147434092|SUPERIORITY|||||||0.858||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||0.858
73950256|NCT02293837|147434093|SUPERIORITY|||||||0.296||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.296
73950257|NCT02293837|147434093|SUPERIORITY|||||||0.145||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.145
73950258|NCT02293837|147434093|SUPERIORITY|||||||0.027||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.027
73950259|NCT02293837|147434094|SUPERIORITY|||||||0.547||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.547
73950260|NCT02293837|147434094|SUPERIORITY|||||||0.551||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.551
73950261|NCT04779242|147434095|OTHER|Difference was observed difference in early clinical success rate between the omadacycline and moxifloxacin groups|Percentage difference|1.9|||||TWO_SIDED|95.0|-3.0|6.8|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification.|||6.8|-3.0|
73950262|NCT04779242|147434096|OTHER|Difference was observed difference in overall clinical success rate at PTE between the omadacycline and moxifloxacin groups.|Percentage difference|-1.7|||||TWO_SIDED|95.0|-6.9|3.4|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification|||3.4|-6.9|
73950263|NCT04779242|147434097|OTHER|Difference was observed difference in overall clinical success rate at PTE between the omadacycline and moxifloxacin groups|Percentage difference|-1.8|||||TWO_SIDED|95.0|-5.7|2.0|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification|||2.0|-5.7|
73950264|NCT01850082|147434108|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.47|TWO_SIDED|95.0|0.83|1.51|||Regression, Cox|||||1.51|0.83|0.47
73870985|NCT01052077|147286281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01||||0.0061|TWO_SIDED|95.0|-3.44|-0.58||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||-0.58|-3.44|0.0061
73870986|NCT01052077|147286281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.0038|TWO_SIDED|95.0|-3.69|-0.72||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||-0.72|-3.69|0.0038
73950265|NCT01850082|147434109|SUPERIORITY|||||||0.821|||||||Chi-squared|||||||0.821
73950266|NCT01850082|147434110|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
73950267|NCT01850082|147434111|SUPERIORITY||Hazard Ratio (HR)|0.923||||0.517|TWO_SIDED|95.0|0.724|1.176|||Regression, Cox|||||1.176|0.724|0.517
73950268|NCT00802737|147434126|SUPERIORITY_OR_OTHER||proportion of responders|0.24|||||TWO_SIDED|95.0|0.07|0.5|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||0.50|0.07|
73950269|NCT00802737|147434126|SUPERIORITY_OR_OTHER||proportion of responders|0.18|||||TWO_SIDED|95.0|0.02|0.52|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||0.52|0.02|
73950270|NCT00802737|147434126|SUPERIORITY_OR_OTHER||proportion of responders|1.0|||||TWO_SIDED|95.0|0.03|1.0|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||1.00|0.03|
73950271|NCT03677128|147434139|OTHER||Mean Difference (Final Values)|23.8|||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
73950272|NCT03677128|147434139|OTHER||Mean Difference (Final Values)|21.1|||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
73950273|NCT00445601|147434163|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.9|||Log Rank|||||0.90|0.48|0.01
73950274|NCT00445601|147434164|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.23|TWO_SIDED|95.0|0.18|1.49|||Log Rank|||||1.49|0.18|0.23
74032494|NCT04742907|147618155|SUPERIORITY||Odds Ratio (OR)|0.52||||0.099|TWO_SIDED|95.0|0.24|1.13||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.13|0.24|0.099
74032495|NCT04742907|147618155|SUPERIORITY||Odds Ratio (OR)|0.78||||0.686|TWO_SIDED|95.0|0.23|2.63||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||2.63|0.23|0.686
74089348|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0002|TWO_SIDED|95.0|1.43|3.14|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.43|0.0002
74089349|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0005|TWO_SIDED|95.0|1.34|2.87|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.34|0.0005
73950275|NCT00214903|147434167|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE, region, and HRT user status.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.||1.3|0.5|
73950276|NCT00214903|147434168|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.3|0.8|||||Hazard ratio was adjusted for age, BMI, hypertension, diabetes, family history of fatal ATE, region, and smoking.|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.||0.8|0.3|
73978144|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
73978145|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
74032496|NCT04742907|147618155|SUPERIORITY||Odds Ratio (OR)|0.75||||0.644|TWO_SIDED|95.0|0.22|2.56||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||2.56|0.22|0.644
74032497|NCT04742907|147618155|SUPERIORITY||Odds Ratio (OR)|0.54||||0.498|TWO_SIDED|95.0|0.09|3.18||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||3.18|0.09|0.498
73978146|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
74032498|NCT04742907|147618155|SUPERIORITY||Odds Ratio (OR)|0.71||||0.7|TWO_SIDED|95.0|0.12|4.05||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||4.05|0.12|0.700
74032499|NCT04742907|147618156|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.9|0.8|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-0.9|0.919
74032500|NCT04742907|147618156|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.016|TWO_SIDED|95.0|-1.8|-0.2|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||-0.2|-1.8|0.016
74032501|NCT04742907|147618156|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.064|TWO_SIDED|95.0|-0.1|2.0|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.0|-0.1|0.064
74032502|NCT04742907|147618156|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.683|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-1.3|0.683
74032503|NCT04742907|147618156|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.462|TWO_SIDED|95.0|-1.0|2.1|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.1|-1.0|0.462
74032504|NCT04742907|147618156|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.343|TWO_SIDED|95.0|-2.3|0.8|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-2.3|0.343
74032505|NCT00210158|147618162|SUPERIORITY||Mean Difference (Final Values)|9.7||||0.5|TWO_SIDED|95.0|-23.4|42.8|||t-test, 2 sided|||T-test for a difference of means, assuming independant samples and unequal variances||42.8|-23.4|0.5
73978147|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
74032506|NCT04716933|147618164|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.48|0.97||||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||0.97|0.48|
74032507|NCT04716933|147618165|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.54|1.12||||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||1.12|0.54|
74032508|NCT04716933|147618166|OTHER||Percent Difference|11.3|||||TWO_SIDED|95.0|-2.0|24.2||||||Comparision based on unstratified Miettinen \& Nurminen method||24.2|-2.0|
74032509|NCT01005719|147618173|SUPERIORITY_OR_OTHER|||||||0.0242||95.0||||p-value for 10-15 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0242
74032510|NCT01005719|147618173|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||p-value for 15-20 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0270
74032511|NCT01005719|147618173|SUPERIORITY_OR_OTHER|||||||0.0067||95.0||||p-value for 20-25 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0067
74032512|NCT01005719|147618174|SUPERIORITY_OR_OTHER|||||||0.0465||95.0||||p-value for 10-15 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||0.0465
74032513|NCT01005719|147618174|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||p-value for 15-20 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||0.0012
74032514|NCT01005719|147618174|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value for 20-25 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||<0.0001
74032515|NCT01005719|147618175|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
74032516|NCT01005719|147618175|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
74032517|NCT01005719|147618175|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
73950277|NCT03918239|147434266|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.079|||||TWO_SIDED|90.0|0.986|1.181|||ANOVA|||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.181|0.986|
73950278|NCT03918239|147434267|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.079|||||TWO_SIDED|90.0|0.987|1.179||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.179|0.987|
73950279|NCT03918239|147434268|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.157|||||TWO_SIDED|90.0|1.044|1.281||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.281|1.044|
73870987|NCT01052077|147286281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.0174|TWO_SIDED|95.0|-3.32|-0.32||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||-0.32|-3.32|0.0174
73950280|NCT01189890|147434282|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.4%.|Difference in LS Means|0.19|||||TWO_SIDED|95.0|0.03|0.34|||ANCOVA|Controlled for treatment, estimated glomerular filtration rate (eGFR) stratum, age stratum, and baseline HbA1C.||||0.34|0.03|
73950281|NCT01189890|147434283|SUPERIORITY_OR_OTHER||Difference in Percent Incidence|-3.9||||0.009|TWO_SIDED|95.0|-7.5|-1.2|||Miettinen & Nurminen|Stratified by estimated glomerular filtration rate (eGFR) stratum and age stratum.||||-1.2|-7.5|0.009
73950282|NCT01189890|147434286|SUPERIORITY_OR_OTHER||Difference in LS Means|6.7|||||TWO_SIDED|95.0|0.7|12.7|||ANCOVA|Controlled for treatment, eGFR stratum, age stratum, and baseline FPG.||||12.7|0.7|
73950283|NCT01189890|147434287|SUPERIORITY_OR_OTHER||Relative Risk|0.7|||||TWO_SIDED|95.0|0.6|0.9|||Miettinen & Nurminen|Stratified by eGFR stratum and age stratum.||||0.9|0.6|
74089350|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0141|TWO_SIDED|95.0|1.11|2.56|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.56|1.11|0.0141
74089351|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0022|TWO_SIDED|95.0|1.26|2.87|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.26|0.0022
74089352|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2286|TWO_SIDED|95.0|0.8|2.5|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|0.80|0.2286
74089353|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|1.47||||0.1808|TWO_SIDED|95.0|0.84|2.57|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|0.84|0.1808
73870988|NCT01052077|147286281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18||||0.1416|TWO_SIDED|95.0|-2.75|0.39||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.39|-2.75|0.1416
73950284|NCT01189890|147434288|SUPERIORITY_OR_OTHER||Relative Risk|0.4|||||TWO_SIDED|95.0|0.3|0.7|||Miettinen & Nurminen|Stratified by eGFR stratum and age stratum.||||0.7|0.3|
73950285|NCT01189890|147434289|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.011|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|Controlled for treatment, eGFR stratum, age stratum, and baseline body weight.||||-0.2|-1.3|0.011
73950286|NCT01807221|147434290|OTHER||Mean Difference (Final Values)|-6.3||||0.8771|TWO_SIDED|90.0|-14.9|2.3|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||2.3|-14.9|0.8771
73950287|NCT01807221|147434290|OTHER||Mean Difference (Final Values)|-4.7||||0.7945|TWO_SIDED|90.0|-13.4|4.0|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||4|-13.4|0.7945
73950288|NCT01807221|147434290|OTHER||Mean Difference (Final Values)|0.1||||0.5|TWO_SIDED|90.0|-8.5|8.8|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||8.8|-8.5|0.5
73950289|NCT01807221|147434290|OTHER||Mean Difference (Final Values)|1.6||||0.4225|TWO_SIDED|90.0|-7.1|10.2|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||10.2|-7.1|0.4225
73978148|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|57.0|||||TWO_SIDED|95.0|41.0|72.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||72|41|
73978149|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|57.0|||||TWO_SIDED|95.0|41.0|72.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||72|41|
73978150|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|0.0|||||TWO_SIDED|95.0|0.0|10.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||10|0|
73978151|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
73978152|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|77.0|||||TWO_SIDED|95.0|61.0|88.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|61|
73978153|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
73978154|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
73978155|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|60.0|||||TWO_SIDED|95.0|44.0|74.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||74|44|
73978156|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|43.0|||||TWO_SIDED|95.0|28.0|59.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||59|28|
73978157|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|31.0|||||TWO_SIDED|95.0|18.0|47.0||||||Children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||47|18|
74032518|NCT01005719|147618175|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
73870989|NCT01052077|147286282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.1481|TWO_SIDED|95.0|-0.21|0.03||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||0.03|-0.21|0.1481
73870990|NCT01052077|147286282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0691|TWO_SIDED|95.0|-0.28|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||0.01|-0.28|0.0691
73978158|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|53.0|82.0||||||Children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||82|53|
74032519|NCT05187013|147618191|SUPERIORITY||Mean Difference (Net)|-7.16|STANDARD_ERROR_OF_MEAN|2.72||0.006|TWO_SIDED|95.0|-12.59|-1.73|||t-test, 1 sided|||Null Hypothesis: No improvement between baseline and final SBP, i.e., Final SBP - Baseline SBP \>= 0 Alternative Hypothesis: Final SBP - Baseline SBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -7.16 and 21.40, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 83.16%||-1.73|-12.59|0.006
73978159|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|61.0|||||TWO_SIDED|95.0|45.0|75.0||||||Children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||75|45|
73978160|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|56.0|||||TWO_SIDED|95.0|40.0|70.0||||||Children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||70|40|
73978161|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||Children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
74032520|NCT05187013|147618191|SUPERIORITY||Mean Difference (Net)|-2.15|STANDARD_ERROR_OF_MEAN|1.32||0.056|TWO_SIDED|95.0|-4.79|0.49|||t-test, 1 sided|||Null Hypothesis: No improvement between baseline and final DBP, i.e., Final DBP - Baseline DBP \>= 0 Alternative Hypothesis: Final DBP - Baseline DBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -2.15 and 10.49, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 51.48%||0.49|-4.79|0.056
74032521|NCT05187013|147618191|EQUIVALENCE|The margin was considered to be 0.|Mean Difference (Net)|-0.67|STANDARD_ERROR_OF_MEAN|4.13||0.87|TWO_SIDED|95.0|-8.76|7.42|||ANCOVA|Adjusted for baseline SBP and follow-up time|The parameter was defined as the change in SBP for the general health education arm - the change in SBP for the HTN specific education arm adjusted for follow-up time and baseline SBP|"Null hypothesis: No difference between the change in SBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level."||7.42|-8.76|0.87
73870991|NCT01052077|147286282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.0457|TWO_SIDED|95.0|-0.35|0.0||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||-0.00|-0.35|0.0457
73870992|NCT01052077|147286282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0061|TWO_SIDED|95.0|-0.45|-0.08||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||-0.08|-0.45|0.0061
73870993|NCT01052077|147286282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0572|TWO_SIDED|95.0|-0.38|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||0.01|-0.38|0.0572
73870994|NCT01052077|147286282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3318|TWO_SIDED|95.0|-0.29|0.1||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.10|-0.29|0.3318
73870995|NCT01052077|147286283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.6272|TWO_SIDED|95.0|-1.02|1.69||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||1.69|-1.02|0.6272
73870996|NCT01052077|147286283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9697|TWO_SIDED|95.0|-1.48|1.54||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo||Week 10||1.54|-1.48|0.9697
73870997|NCT01052077|147286283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.749|TWO_SIDED|95.0|-2.0|1.44||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||1.44|-2.00|0.7490
73870998|NCT01052077|147286283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.9459|TWO_SIDED|95.0|-1.94|1.81||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||1.81|-1.94|0.9459
73950290|NCT01807221|147434290|OTHER||Mean Difference (Final Values)|-3.0||||0.6865|TWO_SIDED|90.0|-11.7|5.7|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||5.7|-11.7|0.6865
73870999|NCT01052077|147286283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9893|TWO_SIDED|95.0|-1.91|1.88||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||1.88|-1.91|0.9893
73871000|NCT01052077|147286283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.8918|TWO_SIDED|95.0|-1.89|2.17||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||2.17|-1.89|0.8918
73950291|NCT02609659|147434302|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the 3-DAA + RBV 600 mg treatment group as compared with the historical rate for 3-DAA + weight-based RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 92% to achieve noninferiority.|percentage of participants|89.5|||||TWO_SIDED|95.0|83.7|95.4||||||||95.4|83.7|
73950292|NCT04711460|147434328|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.003|STANDARD_DEVIATION|5.59||0.003|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||||0.003
73871001|NCT01052077|147286284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.3247|TWO_SIDED|95.0|-1.71|0.57||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.57|-1.71|0.3247
73950293|NCT04711460|147434328|SUPERIORITY|The threshold for statistical significance was set at p=0.05. No power analysis was conducted.|Mean Difference (Final Values)|0.009|STANDARD_DEVIATION|5.59||0.009|ONE_SIDED|95.0||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||0.009
73978162|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||Children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
73871002|NCT01052077|147286285|SUPERIORITY_OR_OTHER|||||||0.5616||||||Cohran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean: brexpiprazole - placebo.||Week 9||||0.5616
73871003|NCT01052077|147286285|SUPERIORITY_OR_OTHER|||||||0.19||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||||0.1900
73871004|NCT01052077|147286285|SUPERIORITY_OR_OTHER|||||||0.0501||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||||0.0501
73950294|NCT04711460|147434328|SUPERIORITY|The Tukey Kramer Post Hoc Test q value = 0.05 threshold|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.609|<|0.05|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Tukey Kramer Post-Hoc|Threshold of statistically significance was set at p=0.05.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||<0.05
73950295|NCT04711460|147434328|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.13||0.003|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.003
73950296|NCT04711460|147434328|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.07||0.454|ONE_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.454
73950297|NCT04711460|147434329|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|7.194||0.002|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||0.002
73950298|NCT04711460|147434329|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.09||0.054|ONE_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.054
73950299|NCT04711460|147434329|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.93||0.019|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.019
73950300|NCT04711460|147434329|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.04||0.101|ONE_SIDED|95.0||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.101
73950301|NCT02080520|147434337|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|||||||0.31
73950302|NCT02080520|147434338|SUPERIORITY|||||||0.52|||||||Mixed Models Analysis|||||||0.52
73950303|NCT02080520|147434339|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
73950304|NCT04397523|147434342|OTHER|||||||0.05||||||p=0.00000|ANOVA|df 2||||||0.05
73950305|NCT04397523|147434347|OTHER|||||||0.05||||||Chi- square = 24.98174, p = 0.00000|Chi-squared|df = 2||Overall survival between the three WHO score groups 3, 4 and 5||||0.05
73950306|NCT04397523|147434347|OTHER|||||||0.05||||||p=0.000|Chi-squared|df = 2||Correlation of mortality versus WHO disease progression score of patients||||0.05
73950307|NCT04397523|147434347|OTHER|||||||0.05||||||p = 0.000|Chi-squared|df = 1||Correlation of mortality versus stay in the intensive care unit (ICU)||||0.05
73950308|NCT02524054|147434359|SUPERIORITY|||||||0.35||||||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||This is a paired t-test comparing the treatment effect of furosemide to the treatment effect of saline in each individual.||||0.35
73950309|NCT02524054|147434360|SUPERIORITY||||||<|0.001||||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for significance was 0.05.|t-test, 2 sided|||||||<0.001
73950310|NCT03537261|147434367|SUPERIORITY||Mean Difference (Net)|5.8||||0.11|TWO_SIDED|95.0|-1.4|13.1|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||13.1|-1.4|0.11
73950311|NCT03537261|147434368|SUPERIORITY||Mean Difference (Net)|-2.2||||0.4|TWO_SIDED|95.0|-7.4|3.0|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||3.0|-7.4|0.40
73950312|NCT03537261|147434369|SUPERIORITY||Mean Difference (Net)|0.6||||0.72|TWO_SIDED|95.0|-2.9|4.2|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||4.2|-2.9|0.72
73950313|NCT04267614|147434450|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73950314|NCT04267614|147434451|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73950315|NCT04267614|147434452|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73950316|NCT04267614|147434453|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73950317|NCT00183456|147434454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|||<|0.01|TWO_SIDED|95.0|0.13|0.63|||Generalized Estimating Equations|||||0.63|0.13|<0.01
73950318|NCT00183456|147434455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.05|TWO_SIDED|95.0|1.22|5.89|||Generalized Estimating Equations|||||5.89|1.22|0.05
73950319|NCT00183456|147434456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.05|TWO_SIDED|95.0|0.16|0.84|||Generalized Estimating Equations|||||0.84|0.16|0.05
73950320|NCT00183456|147434457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82||||0.01|TWO_SIDED|95.0|1.41|5.64|||Generalized Estimating Equations|||||5.64|1.41|0.01
73950321|NCT00183456|147434458|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.01|TWO_SIDED|95.0|0.09|0.68|||Generalized Estimating Equations|||||0.68|0.09|0.01
73950322|NCT00183456|147434459|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.05|TWO_SIDED|95.0|0.25|0.87|||Generalized Estimating Equations|||||0.87|0.25|0.05
73950323|NCT00183456|147434460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.01|TWO_SIDED|95.0|0.21|0.77|||Generalized Estimating Equations|||||0.77|0.21|0.01
73950324|NCT00183456|147434461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.05|TWO_SIDED|95.0|0.14|0.79|||Generalized Estimating Equations|||||0.79|0.14|0.05
73950325|NCT00183456|147434462|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.01|TWO_SIDED|95.0|0.14|0.64|||Generalized Estimating Equations|||||0.64|0.14|0.01
73950326|NCT00183456|147434463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.41||||0.01|TWO_SIDED|95.0|1.25|4.65|||Generalized Estimating Equations|||||4.65|1.25|0.01
73950327|NCT01757067|147434467|OTHER|The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.|||||||||||||||||The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.|||
73950328|NCT03688711|147434494|SUPERIORITY||||||<|0.0001|||||||Log Rank|||The recovery rates of dasiglucagon and placebo were evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests stratified by injection site.||||<0.0001
73950329|NCT03688711|147434495|SUPERIORITY|||||||0.0012|||||||Fisher Exact|||Assessed at 30 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0012
73950330|NCT03688711|147434495|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Assessed at 20 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
73950331|NCT03688711|147434495|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Assessed at 15 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
73950332|NCT03688711|147434495|SUPERIORITY|||||||0.0006|||||||Fisher Exact|||Assessed at 10 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0006
73950333|NCT03688711|147434496|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 30 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
73950334|NCT03688711|147434496|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 20 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
73950335|NCT03688711|147434496|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 15 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
73950336|NCT03688711|147434496|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
73950337|NCT03688711|147434497|SUPERIORITY||||||<|0.0001|||||||Log Rank|||Evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor, analogous to that used for the primary endpoint analysis. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests. Subjects whose time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) was not met within 45 minutes post-dosing were censored, at the time of the last valid plasma glucose measurement up to 45 minutes.||||<0.0001
73950338|NCT03688711|147434498|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.0001|TWO_SIDED|95.0|2.71|6.05|||ANCOVA|||The analysis was an analysis of covariance (ANCOVA) model with treatment group as factor and the baseline of the dependent variable plasma glucose as a covariate.||6.05|2.71|<0.0001
73950339|NCT04675242|147434511|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.4434|TWO_SIDED|95.0|-11.5|15.3|||Fisher Exact|||Difference in the proportion of study eyes with complete cure||15.3|-11.5|0.4434
73950340|NCT04675242|147434512|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.2105|TWO_SIDED|95.0|-9.5|2.1|||ANCOVA|adjusted for baseline eye dryness VAS score||Difference in the change from baseline between treatment groups||2.1|-9.5|0.2105
73950341|NCT04675242|147434513|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.5936|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|adjusted for baseline eye dryness VAS score||Difference in the mean change from baseline||0.1|-0.2|0.5936
73950342|NCT05033080|147434544|NON_INFERIORITY|The non-inferiority margin represents a clinically acceptable loss of effectiveness that margin preserve at least 50% of the treatment effect of the active control (ELX/TEZ/IVA) compared to placebo, where the treatment effect is estimated by the lower bound of the 95% confidence interval (CI).|LS Mean difference|0.2|||<|0.0001|TWO_SIDED|95.0|-0.7|1.1|||Mixed Models Repeated Measures|||||1.1|-0.7|< 0.0001
73950343|NCT05033080|147434545|SUPERIORITY||LS Mean difference|-8.4|||<|0.0001|TWO_SIDED|95.0|-10.5|-6.3|||Mixed Models Repeated Measures|||||-6.3|-10.5|< 0.0001
73950344|NCT05033080|147434546|OTHER||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.55|3.15|||Generalized Estimated Equation Model|||||3.15|1.55|< 0.0001
73871005|NCT01052077|147286285|SUPERIORITY_OR_OTHER|||||||0.0137||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||||0.0137
73871006|NCT01052077|147286285|SUPERIORITY_OR_OTHER|||||||0.0711||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||||0.0711
73871007|NCT01052077|147286285|SUPERIORITY_OR_OTHER|||||||0.3438||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||||0.3438
73950345|NCT05033080|147434547|OTHER||Odds Ratio (OR)|2.87|||<|0.0001|TWO_SIDED|95.0|2.0|4.12|||Generalized Estimated Equation Model|||||4.12|2.00|< 0.0001
73950346|NCT03560245|147434549|EQUIVALENCE|"The change from baseline to Week 13 in the SIB total score was summarized descriptively and compared using Analysis of Covariance (ANCOVA) adjusted for baseline SIB total score.~If the normality assumption was not met, a non-parametric method or a rank-ANCOVA analysis (i.e., an ANCOVA analysis on rank-transformed data) was to be used."||||||0.373|||||||t-test, 2 sided|||||||0.3730
73950347|NCT01263106|147434554|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.12|||||TWO_SIDED|90.0|1.05|1.2|||Mixed Models Analysis|||||1.20|1.05|
73950348|NCT01263106|147434555|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|0.96|||||TWO_SIDED|90.0|0.92|1.01|||Mixed Models Analysis|||||1.01|0.92|
73950349|NCT01263106|147434556|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8008|TWO_SIDED|90.0|-3.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.00|-3.00|0.8008
73950350|NCT03662360|147434559|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations in scores (T3 - T1) regarding the two interest groups of patients (control and treated).||||<0.001
73950351|NCT03662360|147434560|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations scores in T3 and T1, concerning the distress of the professional caregivers in the two intereste groups of patients||||<0.01
73950352|NCT02611830|147434568|SUPERIORITY||Risk Difference (RD)|32.3|||<|0.001|TWO_SIDED|95.0|19.7|45.0||P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||45.0|19.7|<0.001
73950353|NCT02611830|147434569|SUPERIORITY||Risk Difference (RD)|35.7|||<|0.001|TWO_SIDED|95.0|22.1|49.3||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||49.3|22.1|<0.001
73950354|NCT02611830|147434570|SUPERIORITY||Risk Difference (RD)|36.1|||<|0.001|TWO_SIDED|95.0|21.2|50.9||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||50.9|21.2|<0.001
73950355|NCT02611830|147434571|SUPERIORITY||Risk Difference (RD)|9.7||||0.076|TWO_SIDED|95.0|-6.6|25.7||P-value was calculated by Fisher's Exact Test.|Fisher Exact|||||25.7|-6.6|0.076
73950356|NCT02611830|147434572|SUPERIORITY||Risk Difference (RD)|20.6||||0.067|TWO_SIDED|95.0|-4.5|43.7||P-value was calculated by Fisher's Exact Test.|Fisher Exact|||||43.7|-4.5|0.067
73950357|NCT02058290|147434573|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
73950358|NCT02058290|147434574|SUPERIORITY_OR_OTHER|||||||0.2612|||||||ANOVA|||||||0.2612
73950359|NCT02058290|147434575|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Log Rank|||||||0.0019
73950360|NCT05822921|147434586|OTHER|Independent t-test was used.||||||0.871|||||||t-test, 2 sided|||||||.871
73950361|NCT05822921|147434587|OTHER|Independent t-test was used.||||||0.896|||||||t-test, 2 sided|||||||0.896
73950362|NCT05822921|147434588|OTHER|Independent t-test was used.||||||0.351|||||||t-test, 2 sided|||||||0.351
73950363|NCT00544544|147434590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<.001
73950364|NCT00544544|147434591|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73950365|NCT00544544|147434592|SUPERIORITY_OR_OTHER|||||||0.38|||||||Mixed Models Analysis|||||||0.38
73950366|NCT00544544|147434593|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73950367|NCT01857622|147434684|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.8|||||TWO_SIDED|95.0|-14.7|26.8|||Wilcoxon (Mann-Whitney)|no statistical test||||26.8|-14.7|
73950368|NCT01857622|147434684|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.7|||||TWO_SIDED|95.0|-15.4|25.2|||Wilcoxon (Mann-Whitney)|||||25.2|-15.4|
73950369|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|LS mean change|-15.9|STANDARD_ERROR_OF_MEAN|7.76||0.362|TWO_SIDED|95.0|-31.2|-0.6|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Part A)||-0.6|-31.2|0.362
73950370|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|LS mean change|-10.7|STANDARD_ERROR_OF_MEAN|7.12||0.729|TWO_SIDED|95.0|-24.8|3.3|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Part A)||3.3|-24.8|0.729
73950371|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|Least Square Mean Change|-16.5|STANDARD_ERROR_OF_MEAN|4.73||0.173|TWO_SIDED|95.0|-25.8|-7.1|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A + B)||-7.1|-25.8|0.173
73950372|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|Least Square Mean Change|-14.9|STANDARD_ERROR_OF_MEAN|3.25||0.185|TWO_SIDED|95.0|-21.3|-8.5|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A + B)||-8.5|-21.3|0.185
73950373|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean Change|-31.6|STANDARD_ERROR_OF_MEAN|7.71||0.02|TWO_SIDED|95.0|-46.9|-16.3|||ANCOVA|||140 micrograms of Tropifexor (Part C) vs placebo||-16.3|-46.9|0.020
73950374|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean Change|-32.5|STANDARD_ERROR_OF_MEAN|9.1||0.03|TWO_SIDED|95.0|-50.6|-14.5|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Part C)||-14.5|-50.6|0.030
73871008|NCT01052077|147286286|SUPERIORITY_OR_OTHER||Ratio of Response rate|2.79||||0.0679|TWO_SIDED|95.0|0.88|8.81|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9||8.81|0.88|0.0679
73950375|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-13.4|STANDARD_ERROR_OF_MEAN|7.86||0.456|TWO_SIDED|95.0|-26.3|-0.4|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Parts A + B + C)||-0.4|-26.3|0.456
73950376|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-7.5|STANDARD_ERROR_OF_MEAN|7.27||0.966|TWO_SIDED|95.0|-19.5|4.4|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Parts A + B + C)||4.4|-19.5|0.966
73950377|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-13.3|STANDARD_ERROR_OF_MEAN|4.93||0.275|TWO_SIDED|95.0|-21.4|-5.2|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A + B + C)||-5.2|-21.4|0.275
73950378|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-11.8|STANDARD_ERROR_OF_MEAN|3.56||0.304|TWO_SIDED|95.0|-17.6|-5.9|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A + B + C)||-5.9|-17.6|0.304
73950379|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) FAS|LS Mean change|-17.1|STANDARD_ERROR_OF_MEAN|4.45||0.057|TWO_SIDED|95.0|-24.5|-9.8|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Parts A + B + C)||-9.8|-24.5|0.057
73950380|NCT02855164|147434705|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B + C) FAS|LS Mean change|-23.0|STANDARD_ERROR_OF_MEAN|4.49||0.003|TWO_SIDED|95.0|-30.5|-15.6|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Parts A + B + C)||-15.6|-30.5|0.003
73950381|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Full analysis set)|LS Mean change|-9.9|STANDARD_ERROR_OF_MEAN|6.56||0.722|TWO_SIDED|95.0|-22.9|3.0|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Part A)||3.0|-22.9|0.722
73950382|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Full analysis set)|LS Mean change|-2.2|STANDARD_ERROR_OF_MEAN|5.96||0.468|TWO_SIDED|95.0|-14.0|9.5|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Part A)||9.5|-14.0|0.468
73950383|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B) (Full analysis set)|LS Mean change|-8.8|STANDARD_ERROR_OF_MEAN|3.97||0.774|TWO_SIDED|95.0|-16.7|-1.0|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A+B)||-1.0|-16.7|0.774
73950384|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.6|STANDARD_ERROR_OF_MEAN|2.76||0.136|TWO_SIDED|95.0|-6.0|4.9|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A+B)||4.9|-6.0|0.136
73978163|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|36.0|||||TWO_SIDED|95.0|22.0|54.0||||||Children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||54|22|
73950385|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean change|-16.0|STANDARD_ERROR_OF_MEAN|3.97||0.145|TWO_SIDED|95.0|-23.9|-8.2|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Part C)||-8.2|-23.9|0.145
73950386|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean change|-15.3|STANDARD_ERROR_OF_MEAN|4.49||0.236|TWO_SIDED|95.0|-24.2|-6.4|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Part C)||-6.4|-24.2|0.236
73950387|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-7.1|STANDARD_ERROR_OF_MEAN|7.0||0.788|TWO_SIDED|95.0|-18.7|4.4|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Parts A+B+ C)||4.4|-18.7|0.788
73950388|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|0.4|STANDARD_ERROR_OF_MEAN|6.43||0.413|TWO_SIDED|95.0|-10.2|11.0|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Parts A+B+ C)||11.0|-10.2|0.413
73950389|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-6.2|STANDARD_ERROR_OF_MEAN|4.38||0.833|TWO_SIDED|95.0|-13.4|1.0|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A+B+ C)||1.0|-13.4|0.833
73950390|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|2.0|STANDARD_ERROR_OF_MEAN|3.19||0.068|TWO_SIDED|95.0|-3.2|7.3|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A+B+ C)||7.3|-3.2|0.068
73950391|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-0.1|STANDARD_ERROR_OF_MEAN|3.98||0.269|TWO_SIDED|95.0|-6.6|6.5|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Parts A+B+ C)||6.5|-6.6|0.269
73950392|NCT02855164|147434706|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-3.8|STANDARD_ERROR_OF_MEAN|4.05||0.777|TWO_SIDED|95.0|-10.5|2.9|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Parts A+B+ C)||2.9|-10.5|0.777
73950393|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-7.48|STANDARD_ERROR_OF_MEAN|6.174||0.853|TWO_SIDED|95.0|-19.66|4.7|||ANCOVA|||10 microgramsof Tropifexor - Change in percentage of fat in the liver Part A||4.70|-19.66|0.853
73950394|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-14.07|STANDARD_ERROR_OF_MEAN|5.661||0.232|TWO_SIDED|95.0|-25.24|-2.91|||ANCOVA|||30 micrograms of Tropifexor - Change in percentage of fat in the liver Part A||-2.91|-25.24|0.232
73871009|NCT01052077|147286286|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.78||||0.036|TWO_SIDED|95.0|1.01|3.14|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10||3.14|1.01|0.0360
73871010|NCT01052077|147286286|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.53||||0.0521|TWO_SIDED|95.0|0.99|2.35|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11||2.35|0.99|0.0521
73871011|NCT01052077|147286286|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.93||||0.0008|TWO_SIDED|95.0|1.31|2.86|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12||2.86|1.31|0.0008
73950395|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-15.04|STANDARD_ERROR_OF_MEAN|3.754||0.077|TWO_SIDED|95.0|-22.45|-7.64|||ANCOVA|||60 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B||-7.64|-22.45|0.077
73950396|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline|LS Mean change|-12.34|STANDARD_ERROR_OF_MEAN|2.482||0.141|TWO_SIDED|95.0|-17.23|-7.44|||ANCOVA|||90 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B||-7.44|-17.23|0.141
73950397|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-31.25|STANDARD_ERROR_OF_MEAN|5.228|<|0.001|TWO_SIDED|95.0|-41.58|-20.92|||ANCOVA|||140 micrograms of Tropifexor - Change in percentage of fat in the liver Part C||-20.92|-41.58|<0.001
73950398|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-39.54|STANDARD_ERROR_OF_MEAN|4.968|<|0.001|TWO_SIDED|95.0|-49.37|-29.71|||ANCOVA|||200 micrograms of Tropifexor - Change in percentage of fat in the liver Part C||-29.71|-49.37|<0.001
73950399|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-8.09|STANDARD_ERROR_OF_MEAN|6.65||0.872|TWO_SIDED|95.0|-19.06|2.88|||ANCOVA|||10 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||2.88|-19.06|0.872
73950400|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-14.14|STANDARD_ERROR_OF_MEAN|6.198||0.465|TWO_SIDED|95.0|-24.36|-3.91|||ANCOVA|||30 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-3.91|-24.36|0.465
73950401|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-15.02|STANDARD_ERROR_OF_MEAN|4.078||0.228|TWO_SIDED|95.0|-21.75|-8.29|||ANCOVA|||60 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-8.29|-21.75|0.228
73950402|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-12.56|STANDARD_ERROR_OF_MEAN|2.717||0.37|TWO_SIDED|95.0|-17.04|-8.08|||ANCOVA|||90 micrograms - Change in percentage of fat in the liver Parts A+B+C||-8.08|-17.04|0.370
73950403|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-18.71|STANDARD_ERROR_OF_MEAN|3.517||0.029|TWO_SIDED|95.0|-24.51|-12.91|||ANCOVA|||140 micrograms - Change in percentage of fat in the liver Parts A+B+C||-12.91|-24.51|0.029
73950404|NCT02855164|147434707|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-34.38|STANDARD_ERROR_OF_MEAN|3.482|<|0.001|TWO_SIDED|95.0|-40.13|-28.64|||ANCOVA|||200 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-28.64|-40.13|<0.001
73950405|NCT02855164|147434708|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.79|STANDARD_ERROR_OF_MEAN|0.608||0.01|TWO_SIDED|95.0|-2.99|0.59|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.59|-2.99|0.010
73950406|NCT02855164|147434708|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-0.78|STANDARD_ERROR_OF_MEAN|0.567||0.237|TWO_SIDED|95.0|-1.9|0.34|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.34|-1.90|0.237
73950407|NCT02855164|147434708|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.05|STANDARD_ERROR_OF_MEAN|0.377||0.037|TWO_SIDED|95.0|-1.8|0.31|||Mixed Models Analysis|||60 micrograms of Tropifexor (Parts A + B) vs Placebo||0.31|-1.80|0.037
73950408|NCT02855164|147434708|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.15|STANDARD_ERROR_OF_MEAN|0.253||0.007|TWO_SIDED|95.0|-1.65|0.65|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.65|-1.65|0.007
73950409|NCT02855164|147434708|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-5.1|STANDARD_ERROR_OF_MEAN|0.988||0.053|TWO_SIDED|95.0|-7.05|-3.14|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||-3.14|-7.05|0.053
73950410|NCT02855164|147434708|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-5.89|STANDARD_ERROR_OF_MEAN|1.002||0.013|TWO_SIDED|95.0|-7.87|-3.91|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||-3.91|-7.87|0.013
73950411|NCT02855164|147434709|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.64|STANDARD_ERROR_OF_MEAN|0.208||0.006|TWO_SIDED|95.0|-1.05|0.23|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.23|-1.05|0.006
73950412|NCT02855164|147434709|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.29|STANDARD_ERROR_OF_MEAN|0.194||0.177|TWO_SIDED|95.0|-0.67|0.09|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.09|-0.67|0.177
74089354|NCT02697773|147731614|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.57|3.36|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.36|1.57|<.0001
73871012|NCT01052077|147286286|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.64||||0.0074|TWO_SIDED|95.0|1.14|2.38|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13||2.38|1.14|0.0074
73871013|NCT01052077|147286286|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.47||||0.0339|TWO_SIDED|95.0|1.03|2.08|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 14||2.08|1.03|0.0339
73871014|NCT01052077|147286287|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.27||||0.2404|TWO_SIDED|95.0|0.55|9.3|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9||9.30|0.55|0.2404
74032522|NCT05187013|147618191|EQUIVALENCE|The margin was taken to be 0|Mean Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|2.04||0.63|TWO_SIDED|95.0|-3.02|4.98|||ANCOVA|Adjusted for baseline DBP and follow-up time|The parameter was defined as the change in DBP for the general health education arm - the change in DBP for the HTN specific education arm adjusted for follow-up time and baseline SBP|"Null hypothesis: No difference between the change in DBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level."||4.98|-3.02|0.63
74032523|NCT05187013|147618192|EQUIVALENCE|The margin is taken to be 0|Odds Ratio, log|0.89|STANDARD_ERROR_OF_MEAN|0.61||0.14|TWO_SIDED|95.0|-0.26|2.29|||Regression, Logistic|A mixed effect model with study arm as a fixed effect and subject-specific random effect.|For OR: the general education arm was taken as the baseline (denominator)|Null hypothesis: There is no difference in medicine adherence between the two groups||2.29|-0.26|0.14
74032524|NCT05187013|147618193|EQUIVALENCE|The margin was taken to be 0.|Odds Ratio, log|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.32|TWO_SIDED|95.0|-0.58|0.19|||Regression, Logistic|Binomial regression for appointment attended/appointment scheduled.|The baseline (denominator) was taken to be the general education arm.|Null hypothesis: No difference in appointment adherence between the study arms||0.19|-0.58|0.32
74032525|NCT03015610|147618225|SUPERIORITY|||||||0.8716|||||||Wilcoxon (Mann-Whitney)|||||||0.8716
74032526|NCT03015610|147618226|SUPERIORITY|||||||0.2471|||||||Wilcoxon (Mann-Whitney)|||||||0.2471
74032527|NCT03015610|147618227|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
74032528|NCT03015610|147618228|SUPERIORITY|||||||0.2765|||||||Wilcoxon (Mann-Whitney)|||||||0.2765
74032529|NCT03015610|147618229|SUPERIORITY||Risk Ratio (RR)|2.32||||0.191|TWO_SIDED|95.0|0.66|8.2|||Negative binomial regression|||||8.20|0.66|0.191
74032530|NCT03015610|147618230|SUPERIORITY||Risk Ratio (RR)|0.53||||0.0435|TWO_SIDED|95.0|0.29|0.98|||Negative binomial regression|||||0.98|0.29|0.0435
73871015|NCT01052077|147286287|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.04||||0.0983|TWO_SIDED|95.0|0.83|4.98|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10||4.98|0.83|0.0983
74032531|NCT03015610|147618231|SUPERIORITY|||||||0.3808|||||||Wilcoxon (Mann-Whitney)|||||||0.3808
74032532|NCT00752609|147618247|SUPERIORITY_OR_OTHER||Mean change from baseline|-0.42|||||TWO_SIDED|95.0|-0.65|-0.19|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||-0.19|-0.65|
74032533|NCT00752609|147618247|SUPERIORITY_OR_OTHER||Mean change from baseline|0.49|||||TWO_SIDED|95.0|0.26|0.71|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||0.71|0.26|
74032534|NCT05692154|147618254|SUPERIORITY||Least Square Mean Difference|-4.24|STANDARD_ERROR_OF_MEAN|2.015||0.038|TWO_SIDED|95.0|-8.24|-0.23|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance model, with treatment group as fixed effect and baseline TNSS (H0 at Visit 4) as covariate.|||-0.23|-8.24|0.038
74032535|NCT05692154|147618255|SUPERIORITY||Least Square Mean Difference|-4.75|STANDARD_ERROR_OF_MEAN|2.088||0.025|TWO_SIDED|95.0|-8.9|-0.6|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Visit 4) as covariate.|||-0.60|-8.90|0.025
74032536|NCT05692154|147618256|SUPERIORITY||Least Square Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|3.247||0.048|TWO_SIDED|95.0|-12.95|-0.05|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance model, with treatment group as fixed effect and baseline TNSS (H0 at Visit 4) as covariate.|||-0.05|-12.95|0.048
74032537|NCT05692154|147618257|SUPERIORITY||Least Square Mean Difference|-7.47|STANDARD_ERROR_OF_MEAN|2.89||0.011|TWO_SIDED|95.0|-13.21|-1.73|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Visit 4) as covariate.|||-1.73|-13.21|0.011
74032538|NCT05692154|147618258|SUPERIORITY||Least Square Mean Difference|-18.45|STANDARD_ERROR_OF_MEAN|10.211||0.074|TWO_SIDED|95.0|-38.74|1.83|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TNSS (Day 1) as covariate.|||1.83|-38.74|0.074
74032539|NCT05692154|147618259|SUPERIORITY||Least Square Mean Difference|-4.06|STANDARD_ERROR_OF_MEAN|11.672||0.729|TWO_SIDED|95.0|-27.24|19.12|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Day 1) as covariate.|||19.12|-27.24|0.729
74032540|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% confidential interval (CI) on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|Geometric Mean Ratio (GMR)|13.16|||||TWO_SIDED|95.0|8.99|19.28|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|Geometric mean ratio (GMR) of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1||19.28|8.99|
74089355|NCT02697773|147731616|SUPERIORITY||Odds Ratio (OR)|1.44||||0.1463|TWO_SIDED|95.0|0.88|2.34|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.34|0.88|0.1463
73871016|NCT01052077|147286287|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.67||||0.0496|TWO_SIDED|95.0|0.99|2.82|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11||2.82|0.99|0.0496
74032541|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.88|||||TWO_SIDED|95.0|4.32|8.01|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 3||8.01|4.32|
74032542|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.98|||||TWO_SIDED|95.0|12.07|26.78|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 4||26.78|12.07|
73871017|NCT01052077|147286287|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.12||||0.0019|TWO_SIDED|95.0|1.31|3.46|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12||3.46|1.31|0.0019
73871018|NCT01052077|147286287|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.77||||0.0068|TWO_SIDED|95.0|1.17|2.67|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13||2.67|1.17|0.0068
73871019|NCT01052077|147286287|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.71||||0.0089|TWO_SIDED|95.0|1.14|2.57||The CMH general association test controlling for trial center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||2.57|1.14|0.0089
73950413|NCT02855164|147434709|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-0.35|STANDARD_ERROR_OF_MEAN|0.129||0.032|TWO_SIDED|95.0|-0.61|0.1|||Mixed Models Analysis|||60 micrograms of Tropifexor (Parts A + B) vs Placebo||0.10|-0.61|0.032
73950414|NCT02855164|147434709|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.42|STANDARD_ERROR_OF_MEAN|0.087||0.003|TWO_SIDED|95.0|-0.59|0.25|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.25|-0.59|0.003
73978164|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|33.0|||||TWO_SIDED|95.0|20.0|50.0||||||Children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||50|20|
73978165|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
74032543|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.42|||||TWO_SIDED|95.0|1.9|3.08|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 5||3.08|1.90|
74089356|NCT02697773|147731616|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9644|TWO_SIDED|95.0|0.6|1.62|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.62|0.60|0.9644
73950415|NCT02855164|147434709|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-1.88|STANDARD_ERROR_OF_MEAN|0.322||0.015|TWO_SIDED|95.0|-2.51|-1.24|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||-1.24|-2.51|0.015
73950416|NCT02855164|147434709|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-2.11|STANDARD_ERROR_OF_MEAN|0.327||0.004|TWO_SIDED|95.0|-2.75|-1.46|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||-1.46|-2.75|0.004
73950417|NCT02855164|147434710|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.009||0.53|TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.01|-0.03|0.530
73950418|NCT02855164|147434710|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|0.0|STANDARD_ERROR_OF_MEAN|0.008||0.857|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.01|-0.02|0.857
73950419|NCT02855164|147434710|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.005||0.262|TWO_SIDED|95.0|-0.02|0.0|||Mixed Models Analysis|||60 micrograms of Tropifexor (Part A) vs Placebo||0.00|-0.02|0.262
73950420|NCT02855164|147434710|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|0.0|STANDARD_ERROR_OF_MEAN|0.004||0.323|TWO_SIDED|95.0|0.0|0.01|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.01|0.00|0.323
73950421|NCT02855164|147434710|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Part C) (Full analysis set)|LS Mean change|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.1|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||0.01|-0.02|0.100
73978166|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|75.0|96.0||||||Children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|75|
73978167|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
73978168|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
74032544|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.35|||||TWO_SIDED|95.0|4.68|8.61|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A||8.61|4.68|
74032545|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.64|||||TWO_SIDED|95.0|4.92|8.97|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B||8.97|4.92|
73950422|NCT02855164|147434710|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Part C) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.007||0.693|TWO_SIDED|95.0|-0.03|0.0|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||0.00|-0.03|0.693
73950423|NCT02855164|147434722|SUPERIORITY||Risk Difference (RD)|0.004||||1|TWO_SIDED|95.0|-0.214|0.223|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)||0.223|-0.214|1.0000
73978169|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||Children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
73950424|NCT02855164|147434722|SUPERIORITY||Risk Difference (RD)|0.029||||0.8074|TWO_SIDED|95.0|-0.196|0.251|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)||0.251|-0.196|0.8074
73950425|NCT02855164|147434723|SUPERIORITY||Risk Difference (RD)|0.028||||0.807|TWO_SIDED|95.0|-0.191|0.246|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)||0.246|-0.191|0.8070
73950426|NCT02855164|147434723|SUPERIORITY||Risk Difference (RD)|0.052||||0.6233|TWO_SIDED|95.0|-0.173|0.273|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)||0.273|-0.173|0.6233
73950427|NCT02855164|147434724|SUPERIORITY||Risk Difference (RD)|0.004||||1|TWO_SIDED|95.0|-0.214|0.233|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)||0.233|-0.214|1.0000
73950428|NCT02855164|147434724|SUPERIORITY||Risk Difference (RD)|0.029||||0.8074|TWO_SIDED|95.0|-0.196|0.251|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)||0.251|-0.196|0.8074
73950429|NCT02855164|147434725|SUPERIORITY||Risk Difference (RD)|0.034||||0.7028|TWO_SIDED|95.0|-0.184|0.252|||Mixed Models Analysis|||Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)||0.252|-0.184|0.7028
73950430|NCT02855164|147434725|SUPERIORITY||Risk Difference (RD)|0.129||||0.1713|TWO_SIDED|95.0|-0.098|0.345|||Mixed Models Analysis|||Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)||0.345|-0.098|0.1713
73950431|NCT02855164|147434726|SUPERIORITY||Risk Difference (RD)|0.057||||0.2033|TWO_SIDED|95.0|-0.168|0.278|||Mixed Models Analysis|||Resolution of steatohepatitis (FDA, EMA) without worsening of fibrosis (NASH CRN staging)||0.278|-0.168|0.2033
73950432|NCT01644474|147434750|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.6|||<|0.0001|TWO_SIDED|95.0|-40.2|-23.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-23.0|-40.2|<0.0001
73950433|NCT01644474|147434751|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.5|||<|0.0001|TWO_SIDED|95.0|-35.7|-21.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-21.2|-35.7|<0.0001
73950434|NCT01644474|147434752|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|95.0|-32.3|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-32.3|<0.0001
73950435|NCT01644474|147434753|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.5|||<|0.0001|TWO_SIDED|95.0|-33.5|-17.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17.4|-33.5|<0.0001
73950436|NCT01644474|147434754|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.7|||<|0.0001|TWO_SIDED|95.0|-24.7|-12.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-12.7|-24.7|<0.0001
73950437|NCT01644474|147434755|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.7|||<|0.0001|TWO_SIDED|95.0|-31.5|-19.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.8|-31.5|<0.0001
73950438|NCT01644474|147434756|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|95.0|-32.4|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-32.4|<0.0001
73950439|NCT01644474|147434757|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.3|||<|0.0001|TWO_SIDED|95.0|-23.1|-13.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.5|-23.1|<0.0001
73950440|NCT01644474|147434758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|34.8|||<|0.0001|TWO_SIDED|95.0|8.7|139.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||139.0|8.7|<0.0001
73950441|NCT01644474|147434759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|69.8||||0.0001|TWO_SIDED|95.0|8.8|556.0||Threshold for significance was ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||556.0|8.8|0.0001
73950442|NCT01644474|147434760|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4||||0.4013|TWO_SIDED|95.0|-14.8|5.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.9|-14.8|0.4013
73950443|NCT02044458|147434769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||t-test, 2 sided|||||||.70
73871020|NCT01052077|147286288|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.23||||0.4605|TWO_SIDED|95.0|0.7|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 9||2.18|0.70|0.4605
73871021|NCT01052077|147286288|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.2||||0.3267|TWO_SIDED|95.0|0.83|1.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 10||1.72|0.83|0.3267
73871022|NCT01052077|147286288|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.37||||0.023|TWO_SIDED|95.0|1.05|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 11||1.80|1.05|0.0230
73871023|NCT01052077|147286288|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.36||||0.0105|TWO_SIDED|95.0|1.08|1.71|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 12||1.71|1.08|0.0105
73871024|NCT01052077|147286288|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.26||||0.0417|TWO_SIDED|95.0|1.01|1.58|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 13||1.58|1.01|0.0417
73871025|NCT01052077|147286288|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.15||||0.2345|TWO_SIDED|95.0|0.91|1.44||CMH general association test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||1.44|0.91|0.2345
73871026|NCT00042991|147286305|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73871027|NCT00042991|147286306|SUPERIORITY_OR_OTHER|||||||0.0546||95.0|||||Wilcoxon (Mann-Whitney)|||19 patients had Enhancing tumor at both Baseline and Post-RT time points. Thus, the following test was based on these 19 patients.||||0.0546
73950444|NCT02044458|147434770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|||||||t-test, 2 sided|||||||.38
73950445|NCT02044458|147434771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Chi-squared|||||||.57
73978170|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|58.0|||||TWO_SIDED|95.0|42.0|73.0||||||Children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||73|42|
73978171|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|36.0|||||TWO_SIDED|95.0|22.0|52.0||||||Children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||52|22|
73978172|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
73978173|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
73871028|NCT00042991|147286307|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73871029|NCT00042991|147286308|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.18
73871030|NCT04072887|147286317|SUPERIORITY||Least Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0235||0.628|TWO_SIDED|90.0|-0.027|0.05|||ANCOVA|||||0.050|-0.027|0.628
73871031|NCT04072887|147286317|SUPERIORITY||Least Squares Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.0144||0.425|TWO_SIDED|90.0|-0.012|0.035|||ANCOVA|||||0.035|-0.012|0.425
73871032|NCT04072887|147286317|SUPERIORITY||Least Squares Mean Difference|0.013|STANDARD_ERROR_OF_MEAN|0.0174||0.463|TWO_SIDED|90.0|-0.016|0.041|||ANCOVA|||||0.041|-0.016|0.463
73871033|NCT04072887|147286317|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.0173||0.244|TWO_SIDED|90.0|-0.008|0.049|||ANCOVA|||||0.049|-0.008|0.244
73871034|NCT04072887|147286317|SUPERIORITY||Least Squares Mean Difference|0.005|STANDARD_ERROR_OF_MEAN|0.0176||0.793|TWO_SIDED|90.0|-0.024|0.034|||ANCOVA|||||0.034|-0.024|0.793
73871035|NCT02697435|147286333|SUPERIORITY||||||<|0.05||||||P-value is calculated.|Mixed Models Analysis|||||||<0.05
73871036|NCT02178696|147286335|OTHER||Mean Difference (Net)|0.12|STANDARD_DEVIATION|0.31|<|0.001|TWO_SIDED|95.0|0.016|0.23||A p\<0.001 was established for regions a priori hypothesized (e.g. nucleus accumbens).|t-test, 2 sided|||||0.23|0.016|<0.001
73871037|NCT04371666|147286345|OTHER||Least square (LS) Mean Difference|0.083|STANDARD_ERROR_OF_MEAN|0.5494||0.8802|TWO_SIDED|95.0|-1.01|1.176||Threshold for significance at 0.05 level.|Random coefficient model|||||1.176|-1.010|0.8802
73950446|NCT01811563|147434785|EQUIVALENCE|Main effect for implant independent of time||||||0.661|||||||ANOVA|||||||0.661
73950447|NCT01811563|147434785|EQUIVALENCE|Main effect for time independent of implant|||||<|0.001|||||||ANOVA|||||||<0.001
73950448|NCT01811563|147434785|EQUIVALENCE|Interaction between implant and time||||||0.27|||||||ANOVA|||||||0.270
73950449|NCT01811563|147434786|EQUIVALENCE|Main effect for implant independent of time||||||0.856|||||||ANOVA|Main effect for implant, LQ-YBT Baseline to 52 weeks||||||0.856
73950450|NCT01811563|147434786|EQUIVALENCE|Time independent of implant, Baseline to 52 Weeks|||||<|0.001|||||||ANOVA|||||||<0.001
73950451|NCT01811563|147434786|EQUIVALENCE|Implant by Time interaction, Baseline to 52 Weeks between Zimmer and Stryker||||||0.822|||||||ANOVA|||||||0.822
73950452|NCT01811563|147434787|EQUIVALENCE|Main effect for implant, Baseline to 52 weeks||||||0.158|||||||ANOVA|||||||.158
73950453|NCT01811563|147434787|EQUIVALENCE|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
73950454|NCT01811563|147434787|EQUIVALENCE|Interaction of time by implant, Baseline to 52 weeks||||||0.365|||||||ANOVA|||||||0.365
73950455|NCT01811563|147434789|EQUIVALENCE|Main effect for implant, baseline to 52 weeks||||||0.416|||||||ANOVA|||||||.416
73950456|NCT01811563|147434789|EQUIVALENCE|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
73950457|NCT01811563|147434789|EQUIVALENCE|Implant by time interaction, baseline to 52 weeks||||||0.917|||||||ANOVA|||||||0.917
73950458|NCT01811563|147434791|EQUIVALENCE|Main effect by implant, Baseline to 52 weeks||||||0.83|||||||ANOVA|||||||0.830
73950459|NCT01811563|147434791|EQUIVALENCE|Main effect by time, baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
74032546|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.42|||||TWO_SIDED|95.0|6.91|12.83|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F||12.83|6.91|
74032547|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|3.89|||||TWO_SIDED|95.0|2.96|5.1|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V||5.10|2.96|
74032548|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|62.13|||||TWO_SIDED|95.0|40.16|96.12|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 14||96.12|40.16|
74032549|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|16.37|||||TWO_SIDED|95.0|11.22|23.89|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C||23.89|11.22|
74032550|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.25|||||TWO_SIDED|95.0|3.22|5.62|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A||5.62|3.22|
74032551|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.73|||||TWO_SIDED|95.0|6.24|12.21|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F||12.21|6.24|
73871038|NCT00445770|147286381|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Based on rank transformed data: rank of change = rank baseline+treatment +pooled study center+prior methotrexate use. If overall treatment effect statistically significant, 3 pairwise comparisons conducted, otherwise no further testing was made.|ANCOVA|||It was estimated that with 180 participants per group, there would be 81% power for the overall test. With this sample size and 0.05 (2-sided) type I error, there was 88% power to detect a 1.33 difference for the change of mTSS from baseline to 52 weeks between the etanercept 25 mg twice weekly group and Methotrexate group, assuming that the common standard deviation of the change of mTSS from baseline was 4.||||<0.0001
73871039|NCT00445770|147286381|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
74032552|NCT05372575|147618268|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.33|||||TWO_SIDED|95.0|6.15|11.29|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F||11.29|6.15|
74032553|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMR (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|Geometric Mean Ratio (GMR)|4.78|||||TWO_SIDED|95.0|2.32|9.86|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1||9.86|2.32|
74032554|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|9.06|||||TWO_SIDED|95.0|4.72|17.39|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 3||17.39|4.72|
74032555|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|14.37|||||TWO_SIDED|95.0|6.25|33.05|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 4||33.05|6.25|
74032556|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|18.03|||||TWO_SIDED|95.0|8.84|36.8|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 5||36.80|8.84|
74032557|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|33.88|||||TWO_SIDED|95.0|14.33|80.13|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A||80.13|14.33|
74039480|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.4||0.0006|TWO_SIDED|95.0|-2.15|-0.58|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.58|-2.15|0.0006
73950460|NCT01811563|147434791|EQUIVALENCE|Interaction between implant and time, baseline to 52 weeks||||||0.728|||||||ANOVA|||||||0.728
73950461|NCT01811563|147434792|EQUIVALENCE|Between implants at 6 weeks||||||0.319|||||||t-test, 2 sided|||||||0.319
73950462|NCT01946243|147434800|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.||||0.0029
73950463|NCT01946243|147434801|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|4.2|||||ONE_SIDED|97.5|2.7||||||Units: Percent Accuracy||||2.7|
73950464|NCT01946243|147434802|SUPERIORITY_OR_OTHER||lower bound of two-sided 95% CI|0.06|||||TWO_SIDED|95.0|0.018|0.112||||||Superiority demonstrated if lower bound of two-sided 95% confidence interval (CI) greater than 0, for the change in kappa statistic.||0.112|0.018|
73950465|NCT01946243|147434803|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|2.3|||||ONE_SIDED|97.5|0.8||||||Units: Percent Accuracy||||0.8|
73950466|NCT01946243|147434804|SUPERIORITY_OR_OTHER||lower bound of two-sided 95% CI|0.07||||0.028|TWO_SIDED|95.0|0.007|0.125|||Monte Carlo test|||Superiority demonstrated if lower bound of two-sided 95% CI greater than 0, for the change in kappa statistic.||0.125|0.007|0.0280
73950467|NCT01946243|147434805|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.||||0.0025
73950468|NCT00900627|147434849|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|40.0|||||||||||||Dosing started at 160mg. Based on the data seen, 240mg with 33% patients with DLTs, 120mg with 50% patients with DLTs, 80mg with 33% of patients with DLTs and 40mg with 0% patients with DLTs, 40mg was deemed the maximum tolerated dose.|A tolerated dose was defined as one where ≤25% of the patients experienced a DLT. If a dose was tolerated, an increased dose was to be investigated in another group of 3-6 evaluable patients. A non-tolerated dose was defined as one where \>25% of the patients experience a DLT. If a dose was non tolerated, a decreased/intermediate dose could be investigated in another group of 3-6 evaluable patients. The maximum tolerated dose was determined as the maximum dose level that was defined as tolerated.||||
73950469|NCT00900627|147434850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.679|TWO_SIDED|95.0|0.76|1.52||Statistical significance threshold at this analysis was 5%|Cox Proportional Hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||1.52|0.76|0.679
73950470|NCT00900627|147434851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.026|TWO_SIDED|95.0|1.09|3.75||Statistical significance threshold at this analysis was 5%|Logistic Regression|Logistic reg. model with terms for treatment, prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The odds Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a odds ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||3.75|1.09|0.026
73950471|NCT00900627|147434852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.607|TWO_SIDED|95.0|0.67|2.01||Statistical significance threshold at this analysis was 5%|Cox proportional hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||2.01|0.67|0.607
73950472|NCT02291289|147434856|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.872|TWO_SIDED|95.0|0.5|1.82|||Log Rank|||||1.82|0.50|= 0.872
73950473|NCT02291289|147434856|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.666|TWO_SIDED|95.0|0.77|1.18|||Log Rank|||||1.18|0.77|= 0.666
73950474|NCT02291289|147434856|SUPERIORITY||Hazard Ratio (HR)|1.44|||=|0.128|TWO_SIDED|95.0|0.9|2.29|||Log Rank|||||2.29|0.90|= 0.128
73950475|NCT02291289|147434857|SUPERIORITY||Hazard Ratio (HR)|0.71|||=|0.276|TWO_SIDED|95.0|0.39|1.32|||Log Rank|||||1.32|0.39|= 0.276
73950476|NCT02291289|147434857|SUPERIORITY||Hazard Ratio (HR)|0.81|||=|0.076|TWO_SIDED|95.0|0.64|1.02|||Log Rank|||||1.02|0.64|= 0.076
73950477|NCT02291289|147434857|SUPERIORITY||||||=|0.157|||||||Log Rank|||||||= 0.157
73950478|NCT02291289|147434857|SUPERIORITY||Hazard Ratio (HR)|1.25|||=|0.415|TWO_SIDED|95.0|0.73|2.14|||Log Rank|||||2.14|0.73|= 0.415
73950479|NCT02291289|147434859|SUPERIORITY||||||=|0.064|||||||Chi-squared|||||||= 0.064
73950480|NCT02291289|147434859|SUPERIORITY||||||=|0.658|||||||Chi-squared|||||||= 0.658
73950481|NCT02291289|147434859|SUPERIORITY|||||||0.093|||||||Chi-squared|||||||0.093
73950482|NCT02291289|147434860|SUPERIORITY||||||=|0.125|||||||Chi-squared|||||||= 0.125
73950483|NCT02291289|147434860|SUPERIORITY||||||=|0.739|||||||Chi-squared|||||||= 0.739
73950484|NCT02291289|147434860|SUPERIORITY|||||||0.362|||||||Chi-squared|||||||0.362
73950485|NCT02291289|147434862|SUPERIORITY||||||=|0.421|||||||Log Rank|||||||= 0.421
73950486|NCT02291289|147434862|SUPERIORITY||||||=|0.495|||||||Log Rank|||||||= 0.495
73950487|NCT02291289|147434862|SUPERIORITY|||||||0.357|||||||Log Rank|||||||0.357
73950488|NCT01649596|147434867|SUPERIORITY_OR_OTHER||percent|10.0||||0.12|TWO_SIDED||||||Chi-squared|||||||0.12
73950489|NCT01649596|147434868|SUPERIORITY_OR_OTHER||percent|48.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|A t-test for percents was used to compare the number of participants (%) from each group reporting satisfaction (somewhat and highly satisfied).||||||<0.05
73871040|NCT00445770|147286381|NON_INFERIORITY_OR_EQUIVALENCE|An outcome showing that etanercept 10 mg was superior to methotrexate and the presence of numerical difference ≤0.5 mTSS units between etanercept 25 mg and etanercept 10 mg would support non-inferiority for the 2 etanercept treatments.||||||0.2634|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||0.2634
74032558|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|14.05|||||TWO_SIDED|95.0|6.07|32.52|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B||32.52|6.07|
73871041|NCT00445770|147286382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
73950490|NCT00962585|147434869|SUPERIORITY_OR_OTHER|||||||0.573||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|ANCOVA|"Model (Analysis of covariance): Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.~The ANCOVA procedure was used to test the following hypotheses:~H0: μ1 = μp versus HA: μ1 ≠ μp where μ1 and μp denote the mean frequency of MSVS (at Week 4 in case of primary efficacy endpoint), adjusted for Baseline MSVS values, in the treatment and placebo groups, respectively."||||0.5730
73950491|NCT00962585|147434869|SUPERIORITY_OR_OTHER||LS means difference|1.13|||>|0.05|TWO_SIDED|95.0|-10.06|12.32|||Pair-wise comparisons|||||12.32|-10.06|>0.05
73950492|NCT00962585|147434869|SUPERIORITY_OR_OTHER||LS means difference|6.98|||>|0.05|TWO_SIDED|95.0|-3.87|17.84|||Pair-wise comparisons|||||17.84|-3.87|>0.05
73950493|NCT00962585|147434869|SUPERIORITY_OR_OTHER||LS means difference|0.94|||>|0.05|TWO_SIDED|95.0|-10.16|12.04|||Pair-wise comparisons|||||12.04|-10.16|>0.05
73950494|NCT00962585|147434870|SUPERIORITY_OR_OTHER|||||||0.7364||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|ANCOVA|"Model: Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7~1-week period = remaining days of the period since the last visit (i.e. period following first 7 days, as per CRF)"||||0.7364
73950495|NCT00962585|147434870|SUPERIORITY_OR_OTHER||LS means difference|-0.19|||>|0.05|TWO_SIDED|95.0|-12.38|12.01|||Pair-wise comparisons|||||12.01|-12.38|>0.05
73950496|NCT00962585|147434870|SUPERIORITY_OR_OTHER||LS means difference|4.77|||>|0.05|TWO_SIDED|95.0|-6.94|16.48|||Pair-wise comparisons|||||16.48|-6.94|>0.05
73978174|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|86.0|100.0||||||Children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|86|
73950497|NCT00962585|147434870|SUPERIORITY_OR_OTHER||LS means difference|-1.63|||>|0.05|TWO_SIDED|95.0|-13.41|10.15|||Pair-wise comparisons|||||10.15|-13.41|>0.05
73978175|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
73950498|NCT00962585|147434871|SUPERIORITY_OR_OTHER|||||||0.1217||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 1 and 2.|Repeated measures ANCOVA|"Mixed Model: MSVS = Baseline (MSVS) + Treatment + Site + Weeks + Treatment x Weeks~Difference Between Means: S-equol treatment group - Placebo"||\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.||||0.1217
73950499|NCT00962585|147434871|SUPERIORITY_OR_OTHER||LS means difference|-3.77|||>|0.05||95.0|-12.69|5.16|||Pair-wise comparisons|||Week 1, Treatment Effect||5.16|-12.69|>0.05
73978176|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
73978177|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||Children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
73978178|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
73978179|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
73950500|NCT00962585|147434871|SUPERIORITY_OR_OTHER||LS means difference|9.69|||<|0.05|TWO_SIDED|95.0|0.79|18.6|||Pair-wise comparisons|||Week 1, Treatment Effect||18.60|0.79|<0.05
73950501|NCT00962585|147434871|SUPERIORITY_OR_OTHER||LS means difference|1.31|||>|0.05|TWO_SIDED|95.0|-7.73|10.36|||Pair-wise comparisons|||Week 1, Treatment Effect||10.36|-7.73|>0.05
73978180|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|56.0|||||TWO_SIDED|95.0|40.0|70.0||||||Children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||70|40|
73871042|NCT00445770|147286382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
73871043|NCT00445770|147286382|SUPERIORITY_OR_OTHER|||||||0.2248|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||0.2248
73871044|NCT00445770|147286383|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
73871045|NCT00445770|147286383|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
73871046|NCT00445770|147286383|SUPERIORITY_OR_OTHER|||||||0.726|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.7260
73871047|NCT00445770|147286383|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
73950502|NCT00962585|147434871|SUPERIORITY_OR_OTHER||LS means difference|-6.7|||>|0.05|TWO_SIDED|95.0|-18.36|4.96|||Pair-wise comparisons|||Week 2, Treatment Effect||4.96|-18.36|>0.05
73950503|NCT00962585|147434871|SUPERIORITY_OR_OTHER||LS means difference|3.56|||>|0.05|TWO_SIDED|95.0|-8.01|15.14|||Pair-wise comparisons|||Week 2, Treatment Effect||15.14|-8.01|>0.05
73950504|NCT00962585|147434871|SUPERIORITY_OR_OTHER||LS means difference|0.91|||>|0.05|TWO_SIDED|95.0|-10.77|12.58|||Pair-wise comparisons|||Week 2, Treatment Effect||12.58|-10.77|>0.05
73950505|NCT00962585|147434872|SUPERIORITY_OR_OTHER|||||||0.1609||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 1, 2 and 4.|Repeated measures ANCOVA|Mixed Model: Severity of VMS = Baseline (severity of VMS) + Treatment + Site + Weeks + Treatment x Weeks||Severity of VMS per week at each protocol visits = (Sum of scores of Mild, Moderate, Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7, where severity of vasomotor symptoms are scored as: 1 = mild, 2 = moderate and 3 = severe.||||0.1609
73950506|NCT00962585|147434872|SUPERIORITY_OR_OTHER||LS means difference|-6.34|||>|0.05|TWO_SIDED|95.0|-26.41|13.73|||Pair-wise comparisons|||Week 1, Treatment Effect||13.73|-26.41|>0.05
73950507|NCT00962585|147434872|SUPERIORITY_OR_OTHER||LS means difference|25.67|||<|0.05|TWO_SIDED|95.0|5.64|45.69|||Pair-wise comparisons|||Week 1, Treatment Effect||45.69|5.64|<0.05
73950508|NCT00962585|147434872|SUPERIORITY_OR_OTHER||LS means difference|2.09|||>|0.05|TWO_SIDED|95.0|-18.21|22.39|||Pair-wise comparisons|||Week 1, Treatment Effect||22.39|-18.21|>0.05
73871048|NCT00445770|147286383|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
73871049|NCT00445770|147286383|SUPERIORITY_OR_OTHER|||||||0.5717|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.5717
73950509|NCT00962585|147434872|SUPERIORITY_OR_OTHER||LS means difference|-16.14|||>|0.05|TWO_SIDED|95.0|-43.29|11.01|||Pair-wise comparisons|||Week 2, Treatment Effect||11.01|-43.29|>0.05
73978181|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|44.0|||||TWO_SIDED|95.0|30.0|60.0||||||children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||60|30|
73871050|NCT00445770|147286384|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
73871051|NCT00445770|147286384|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.0013
73950510|NCT00962585|147434872|SUPERIORITY_OR_OTHER||LS means difference|8.73|||>|0.05|TWO_SIDED|95.0|-18.19|35.65|||Pair-wise comparisons|||Week 2, Treatment Effect||35.65|-18.19|>0.05
73950511|NCT00962585|147434872|SUPERIORITY_OR_OTHER||LS means difference|-0.65|||>|0.05|TWO_SIDED|95.0|-27.8|26.5|||Pair-wise comparisons|||Week 2, Treatment Effect||26.50|-27.80|>0.05
73950512|NCT00962585|147434872|SUPERIORITY_OR_OTHER||LS means difference|-1.69|||>|0.05|TWO_SIDED|95.0|-28.68|25.3|||Pair-wise comparisons|||Week 4, Treatment Effect||25.30|-28.68|>0.05
73950513|NCT00962585|147434872|SUPERIORITY_OR_OTHER||LS means difference|16.15|||>|0.05|TWO_SIDED|95.0|-10.4|42.71|||Pair-wise comparisons|||Week 4, Treatment Effect||42.71|-10.40|>0.05
73950514|NCT00962585|147434872|SUPERIORITY_OR_OTHER||LS means difference|-1.29|||>|0.05|TWO_SIDED|95.0|-28.18|25.6|||Pair-wise comparisons|||Week 4, Treatment Effect||25.60|-28.18|>0.05
73950515|NCT00962585|147434873|SUPERIORITY_OR_OTHER|||||||0.2211||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal pH) = Baseline (Vaginal pH) + Treatment + Site + Weeks + Treatment x Weeks||||||0.2211
73950516|NCT00962585|147434873|SUPERIORITY_OR_OTHER||LS means difference|-0.21|||>|0.05|TWO_SIDED|95.0|-0.53|0.12|||Pair-wise comparisons|||Week 2, Treatment Effect||0.12|-0.53|>0.05
73950517|NCT00962585|147434873|SUPERIORITY_OR_OTHER||LS means difference|-0.23|||>|0.05|TWO_SIDED|95.0|-0.55|0.09|||Pair-wise comparisons|||Week 2, Treatment Effect||0.09|-0.55|>0.05
73950518|NCT00962585|147434873|SUPERIORITY_OR_OTHER||LS means difference|0.03|||>|0.05|TWO_SIDED|95.0|-0.28|0.35|||Pair-wise comparisons|||Week 2, Treatment Effect||0.35|-0.28|>0.05
73950519|NCT00962585|147434873|SUPERIORITY_OR_OTHER||LS means difference|-0.26|||>|0.05|TWO_SIDED|95.0|-0.54|0.02|||Pair-wise comparisons|||Week 4, Treatment Effect||0.02|-0.54|>0.05
73950520|NCT00962585|147434873|SUPERIORITY_OR_OTHER||LS means difference|-0.13|||>|0.05|TWO_SIDED|95.0|-0.4|0.14|||Pair-wise comparisons|||Week 4, Treatment Effect||0.14|-0.40|>0.05
73950521|NCT00962585|147434873|SUPERIORITY_OR_OTHER||LS means difference|-0.24|||>|0.05|TWO_SIDED|95.0|-0.51|0.03|||Pair-wise comparisons|||Week 4, Treatment Effect||0.03|-0.51|>0.05
74032559|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|16.99|||||TWO_SIDED|95.0|7.85|36.76|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F||36.76|7.85|
74032560|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|19.31|||||TWO_SIDED|95.0|9.13|40.84|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V||40.84|9.13|
74032561|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.46|||||TWO_SIDED|95.0|4.74|23.1|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 14||23.10|4.74|
74032562|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.13|||||TWO_SIDED|95.0|6.0|24.51|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C||24.51|6.00|
74032563|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|23.65|||||TWO_SIDED|95.0|10.94|51.1|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A||51.10|10.94|
74032564|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|17.62|||||TWO_SIDED|95.0|8.65|35.93|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F||35.93|8.65|
74032565|NCT05372575|147618269|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|44.46|||||TWO_SIDED|95.0|19.11|103.43|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F||103.43|19.11|
73871052|NCT00445770|147286384|SUPERIORITY_OR_OTHER|||||||0.0186|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.0186
74032566|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|Geometric Mean Ratio (GMR)|0.48|||||TWO_SIDED|95.0|0.16|1.42|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1||1.42|0.16|
74032567|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.27|1.98|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 3||1.98|0.27|
74032568|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.21|2.19|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 4||2.19|0.21|
73871053|NCT00445770|147286384|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
74032569|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.82|||||TWO_SIDED|95.0|0.36|1.86|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 5||1.86|0.36|
74089357|NCT02697773|147731616|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0422|TWO_SIDED|95.0|1.02|2.59|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.59|1.02|0.0422
73871054|NCT00445770|147286384|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.0006
73871055|NCT00445770|147286384|SUPERIORITY_OR_OTHER|||||||0.1123|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.1123
73871056|NCT00445770|147286385|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||<0.0001
74032570|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.25|1.89|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A||1.89|0.25|
74032571|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.27|2.07|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B||2.07|0.27|
74032572|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.42|||||TWO_SIDED|95.0|0.16|1.09|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F||1.09|0.16|
74032573|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.8|||||TWO_SIDED|95.0|0.35|1.81|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V||1.81|0.35|
74032574|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.66|||||TWO_SIDED|95.0|0.2|2.24|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 14||2.24|0.20|
74032575|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.6|||||TWO_SIDED|95.0|0.22|1.65|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C||1.65|0.22|
74032576|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.55|||||TWO_SIDED|95.0|0.61|3.93|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A||3.93|0.61|
74032577|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.8|||||TWO_SIDED|95.0|0.65|4.99|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F||4.99|0.65|
74032578|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.47|||||TWO_SIDED|95.0|0.17|1.31|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F||1.31|0.17|
73871057|NCT00445770|147286385|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||0.0002
74032579|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.65|||||TWO_SIDED|95.0|0.31|1.38|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1||1.38|0.31|
74032580|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.7|||||TWO_SIDED|95.0|0.4|1.24|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 3||1.24|0.40|
74032581|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.73|||||TWO_SIDED|95.0|0.33|1.59|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 4||1.59|0.33|
74032582|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.8|||||TWO_SIDED|95.0|0.52|1.25|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 5||1.25|0.52|
73871058|NCT00445770|147286385|SUPERIORITY_OR_OTHER|||||||0.3022|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||0.3022
73871059|NCT00445770|147286385|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.0001
73950522|NCT00962585|147434874|SUPERIORITY_OR_OTHER|||||||0.6375||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal Maturation Index) = Baseline (Vaginal Maturation Index) + Treatment + Site + Weeks + Treatment x Weeks||Vaginal maturation index = 0.2 x (% parabasal cells) + 0.6 x(% intermediate cells) + 1.0 x (% superficial cells)||||0.6375
73950523|NCT00962585|147434874|SUPERIORITY_OR_OTHER||LS means difference|-1.58|||>|0.05|TWO_SIDED|95.0|-9.57|6.42|||Pair-wise comparisons|||Week 2, Treatment Effect||6.42|-9.57|>0.05
73950524|NCT00962585|147434874|SUPERIORITY_OR_OTHER||LS means difference|-1.58|||>|0.05|TWO_SIDED|95.0|-9.63|6.46|||Pair-wise comparisons|||Week 2, Treatment Effect||6.46|-9.63|>0.05
73950525|NCT00962585|147434874|SUPERIORITY_OR_OTHER||LS means difference|-1.59|||>|0.05|TWO_SIDED|95.0|-9.66|6.47|||Pair-wise comparisons|||Week 2, Treatment Effect||6.47|-9.66|>0.05
73950526|NCT00962585|147434874|SUPERIORITY_OR_OTHER||LS means difference|-0.31|||>|0.05|TWO_SIDED|95.0|-6.73|6.11|||Pair-wise comparisons|||Week 4, Treatment Effect||6.11|-6.73|>0.05
73950527|NCT00962585|147434874|SUPERIORITY_OR_OTHER||LS means difference|-6.14|||>|0.05|TWO_SIDED|95.0|-12.36|0.07|||Pair-wise comparisons|||Week 4, Treatment Effect||0.07|-12.36|>0.05
73950528|NCT00962585|147434874|SUPERIORITY_OR_OTHER||LS means difference|-2.88|||>|0.05|TWO_SIDED|95.0|-9.05|3.28|||Pair-wise comparisons|||Week 4, Treatment Effect||3.28|-9.05|>0.05
73950529|NCT00962585|147434875|SUPERIORITY_OR_OTHER|||||||0.0681||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Estradiol) = Baseline (Estradiol) + Treatment + Site + Weeks + Treatment x Weeks||||||0.0681
73950530|NCT00962585|147434875|SUPERIORITY_OR_OTHER||LS means difference|35.32|||>|0.05|TWO_SIDED|95.0|1.75|68.9|||Pair-wise comparisons|||Week 2, Treatment Effect||68.90|1.75|>0.05
73950531|NCT00962585|147434875|SUPERIORITY_OR_OTHER||LS means difference|3.61|||>|0.05|TWO_SIDED|95.0|-29.12|36.34|||Pair-wise comparisons|||Week 2, Treatment Effect||36.34|-29.12|>0.05
73950532|NCT00962585|147434875|SUPERIORITY_OR_OTHER||LS means difference|-4.58|||>|0.05|TWO_SIDED|95.0|-37.39|28.23|||Pair-wise comparisons|||Week 2, Treatment Effect||28.23|-37.39|>0.05
73950533|NCT00962585|147434875|SUPERIORITY_OR_OTHER||LS means difference|22.12|||>|0.05|TWO_SIDED|95.0|-23.56|67.8|||Pair-wise comparisons|||Week 4, Treatment Effect||67.80|-23.56|>0.05
73950534|NCT00962585|147434875|SUPERIORITY_OR_OTHER||LS means difference|7.8|||>|0.05|TWO_SIDED|95.0|-36.7|52.29|||Pair-wise comparisons|||Week 4, Treatment Effect||52.29|-36.70|>0.05
73978182|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
73978183|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||Children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
73950535|NCT00962585|147434875|SUPERIORITY_OR_OTHER||LS means difference|-22.74|||>|0.05|TWO_SIDED|95.0|-67.44|21.96|||Pair-wise comparisons|||Week 4, Treatment Effect||21.96|-67.44|>0.05
73950536|NCT00962585|147434879|SUPERIORITY_OR_OTHER|||||||0.0475||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0475
73950537|NCT00962585|147434879|SUPERIORITY_OR_OTHER|||||||0.0258||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0258
73950538|NCT00962585|147434879|SUPERIORITY_OR_OTHER|||||||0.0281||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0281
73950539|NCT00962585|147434879|SUPERIORITY_OR_OTHER|||||||0.0645||95.0|||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.||||0.0645
73950540|NCT00962585|147434880|SUPERIORITY_OR_OTHER|||||||0.0097||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4||||||0.0097
73950541|NCT00962585|147434881|SUPERIORITY_OR_OTHER|||||||0.4352||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.4352
73950542|NCT00962585|147434881|SUPERIORITY_OR_OTHER|||||||0.26||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.2600
73950543|NCT00962585|147434881|SUPERIORITY_OR_OTHER|||||||0.7037||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.7037
73950544|NCT00962585|147434881|SUPERIORITY_OR_OTHER|||||||0.7155|||||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.||||0.7155
73950545|NCT00962585|147434882|SUPERIORITY_OR_OTHER|||||||0.0381||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4||||||0.0381
73950546|NCT00883103|147434883|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73978184|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|19.0|||||TWO_SIDED|95.0|10.0|35.0||||||children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||35|10|
73871060|NCT00445770|147286385|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.0002
73871061|NCT00445770|147286385|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.3120
73950547|NCT01254565|147434944|SUPERIORITY|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-76.9|||<|0.0001|TWO_SIDED|95.0|-86.9|-50.0|||ANOVA|A rank analysis of variance (ANOVA) model with treatment and screening PTH (\< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.||-50.0|-86.9|<0.0001
73950548|NCT01254565|147434944|SUPERIORITY|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-36.7||||0.0032|TWO_SIDED|95.0|-59.8|-13.6|||ANOVA|ANOVA model with treatment and screening PTH (\< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.||-13.6|-59.8|0.0032
73950549|NCT01254565|147434945|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73950550|NCT01254565|147434945|SUPERIORITY|||||||0.0968|||||||Fisher Exact|||||||0.0968
73950551|NCT01254565|147434946|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73950552|NCT01254565|147434946|SUPERIORITY|||||||0.073|||||||Fisher Exact|||||||0.0730
73950553|NCT01254565|147434947|SUPERIORITY||LS Mean Difference|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.4|-8.4|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-8.4|-16.4|< 0.0001
73950554|NCT01254565|147434947|SUPERIORITY||LS Mean Difference|-6.9||||0.0235|TWO_SIDED|95.0|-12.8|-1.0|||ANOVA|ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-1.0|-12.8|0.0235
73950555|NCT01254565|147434948|SUPERIORITY||LS Mean Difference|-4.2||||0.2255|TWO_SIDED|95.0|-18.6|5.7|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||5.7|-18.6|0.2255
73978185|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Young children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
73978186|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||Young children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
73871062|NCT00445770|147286385|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use.|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0010
73950556|NCT01254565|147434948|SUPERIORITY||LS mean Difference|-21.8||||0.1751|TWO_SIDED|95.0|-29.8|5.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||5.9|-29.8|0.1751
73950557|NCT01254565|147434949|SUPERIORITY||LS Mean Difference|-11.2||||0.0112|TWO_SIDED|95.0|-26.8|-4.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-4.9|-26.8|0.0112
73950558|NCT01254565|147434949|SUPERIORITY||LS Mean Difference|-27.7||||0.0554|TWO_SIDED|95.0|-39.3|-1.6|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-1.6|-39.3|0.0554
73950559|NCT03748979|147434956|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|Mixed Model for Repeated Measures (MMRM)|||||||<0.0001
73950560|NCT03748979|147434956|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
73950561|NCT03748979|147434956|SUPERIORITY|||||||0.0002||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||0.0002
73950562|NCT03748979|147434956|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
73950563|NCT03748979|147434956|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
73978187|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||young children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
73978188|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|53.0|||||TWO_SIDED|95.0|37.0|68.0||||||young children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||68|37|
73978189|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Young children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
73978190|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
73871063|NCT00445770|147286385|SUPERIORITY_OR_OTHER|||||||0.0285|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0285
73871064|NCT00445770|147286385|SUPERIORITY_OR_OTHER|||||||0.0433|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0433
73950564|NCT03748979|147434956|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
73950565|NCT03748979|147434956|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
73950566|NCT03748979|147434956|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
73978191|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Young children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
73978192|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Young children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
73978193|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|86.0|100.0||||||Young children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|86|
73978194|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||young children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
73871065|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.0032|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0032
73950567|NCT02564055|147434961|OTHER||Difference in percentages|22.6|||||TWO_SIDED|95.0|-2.4|45.5|||||Difference between GSK2894512 1 percent BID and Vehicle BID has been presented.|||45.5|-2.4|
73978195|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|81.0|||||TWO_SIDED|95.0|65.0|90.0||||||Young children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|65|
73978196|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|68.0|92.0||||||young children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|68|
73978197|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|Slope|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||young children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
73978198|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|53.0|82.0||||||Young children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||82|53|
73871066|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73950568|NCT02564055|147434961|OTHER||Difference in percentages|7.4|||||TWO_SIDED|95.0|-18.3|32.0|||||Difference between GSK2894512 1 percent QD and Vehicle QD has been presented.|||32.0|-18.3|
73950569|NCT02564055|147434961|OTHER||Difference in percentages|14.3|||||TWO_SIDED|95.0|-11.2|38.7|||||Difference between GSK2894512 0.5 percent BID and Vehicle BID has been presented.|||38.7|-11.2|
73950570|NCT02564055|147434961|OTHER||Difference in percentages|-4.0|||||TWO_SIDED|95.0|-29.3|21.6|||||Difference between GSK2894512 0.5 percent QD and Vehicle QD has been presented.|||21.6|-29.3|
73978199|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|8.0|||||TWO_SIDED|95.0|3.0|22.0||||||Young children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||22|3|
73978200|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Young children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
73978201|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||young children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
73978202|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|50.0|||||TWO_SIDED|95.0|34.0|66.0||||||young children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||66|34|
73871067|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.1224|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.1224
73871068|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73978203|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||young children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
73978204|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|31.0|||||TWO_SIDED|95.0|18.0|47.0||||||young children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||47|18|
73978205|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||young children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
73978206|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|3.0|||||TWO_SIDED|95.0|0.0|14.0||||||young children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||14|0|
73978207|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|75.0|96.0||||||young children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|75|
73978208|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|96.0||||||young children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|56|
73978209|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|47.0|||||TWO_SIDED|95.0|32.0|63.0||||||young children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||63|32|
73978210|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
73978211|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
73978212|NCT02678455|147502006|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|22.0|||||TWO_SIDED|95.0|12.0|38.0||||||young children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||38|12|
73978213|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|0.1491|STANDARD_ERROR_OF_MEAN|0.51||0.7695||95.0|-0.856|1.15||Alpha for significance=0.05 for all tests.|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician treatment arm."||1.15|-.856|.7695
73978214|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.5077||0.0878||95.0|-1.88|0.13||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm."||.13|-1.88|.0878
73978215|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|0.2414|STANDARD_ERROR_OF_MEAN|0.5077||0.635||95.0|-0.76|1.25||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/physician treatment arm."||1.25|-.76|.635
73978216|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|-0.06574|STANDARD_ERROR_OF_MEAN|0.5077||0.897||95.0|-1.0709|0.9394||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the older adult treatment arm."||.9394|-1.0709|.897
74032583|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.93|||||TWO_SIDED|95.0|0.57|1.52|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A||1.52|0.57|
73871069|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73871070|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.8037|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.8037
73950571|NCT02564055|147434969|OTHER||Difference in percentages|21.1|||||TWO_SIDED|95.0|-2.7|43.1|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||43.1|-2.7|
73978217|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|-0.01126|STANDARD_ERROR_OF_MEAN|0.5077||0.9823||95.0|-1.0164|0.9939||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician/older adult treatment arm."||.9939|-1.0164|.9823
73978218|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|-0.4928|STANDARD_ERROR_OF_MEAN|0.5077||0.3337||95.0|-1.4979|0.5124||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm."||.5124|-1.4979|.3337
73871071|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73950572|NCT02564055|147434969|OTHER||Difference in percentages|26.5|||||TWO_SIDED|95.0|3.3|47.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.|||47.5|3.3|
73950573|NCT02564055|147434969|OTHER||Difference in percentages|2.3|||||TWO_SIDED|95.0|-19.5|24.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 1 has been presented.|||24.5|-19.5|
73950574|NCT02564055|147434969|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-14.5|32.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.|||32.0|-14.5|
73950575|NCT02564055|147434969|OTHER||Difference in percentages|23.1|||||TWO_SIDED|95.0|-0.3|44.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.|||44.6|-0.3|
73950576|NCT02564055|147434969|OTHER||Difference in percentages|37.7|||||TWO_SIDED|95.0|14.7|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.|||57.6|14.7|
73950577|NCT02564055|147434969|OTHER||Difference in percentages|5.1|||||TWO_SIDED|95.0|-18.0|27.8|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.|||27.8|-18.0|
73950578|NCT02564055|147434969|OTHER||Difference in percentages|17.1|||||TWO_SIDED|95.0|-6.4|39.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.|||39.0|-6.4|
73950579|NCT02564055|147434969|OTHER||Difference in percentages|39.6|||||TWO_SIDED|95.0|16.0|60.0|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.|||60.0|16.0|
73950580|NCT02564055|147434969|OTHER||Difference in percentages|31.2|||||TWO_SIDED|95.0|7.8|52.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.|||52.1|7.8|
73950581|NCT02564055|147434969|OTHER||Difference in percentages|26.5|||||TWO_SIDED|95.0|2.3|48.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.|||48.4|2.3|
73950582|NCT02564055|147434969|OTHER||Difference in percentages|18.3|||||TWO_SIDED|95.0|-5.3|40.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.|||40.5|-5.3|
73950583|NCT02564055|147434969|OTHER||Difference in percentages|21.9|||||TWO_SIDED|95.0|-2.3|44.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.|||44.7|-2.3|
73950584|NCT02564055|147434969|OTHER||Difference in percentages|36.3|||||TWO_SIDED|95.0|12.1|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.|||57.6|12.1|
73950585|NCT02564055|147434969|OTHER||Difference in percentages|26.7|||||TWO_SIDED|95.0|1.7|49.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.|||49.0|1.7|
73950586|NCT02564055|147434969|OTHER||Difference in percentages|23.4|||||TWO_SIDED|95.0|-1.5|46.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.|||46.1|-1.5|
73950587|NCT02564055|147434969|OTHER||Difference in percentages|19.0|||||TWO_SIDED|95.0|-6.0|42.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||42.3|-6.0|
73950588|NCT02564055|147434969|OTHER||Difference in percentages|-0.2|||||TWO_SIDED|95.0|-25.0|25.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||25.0|-25.0|
73950589|NCT02564055|147434969|OTHER||Difference in percentages|32.6|||||TWO_SIDED|95.0|6.9|55.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||55.0|6.9|
73950590|NCT02564055|147434969|OTHER||Difference in percentages|-9.7|||||TWO_SIDED|95.0|-34.6|16.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||16.1|-34.6|
73950591|NCT02564055|147434969|OTHER||Difference in percentages|22.3|||||TWO_SIDED|95.0|-3.1|45.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||45.3|-3.1|
73950592|NCT02564055|147434969|OTHER||Difference in percentages|6.3|||||TWO_SIDED|95.0|-19.5|31.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||31.5|-19.5|
73978219|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|0.2002|STANDARD_ERROR_OF_MEAN|0.5077||0.694||95.0|-0.8049|1.2054||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult/physician treatment arm."||1.2054|-.8049|.694
73950593|NCT02564055|147434969|OTHER||Difference in percentages|17.7|||||TWO_SIDED|95.0|-8.4|41.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||41.9|-8.4|
73950594|NCT02564055|147434969|OTHER||Difference in percentages|7.8|||||TWO_SIDED|95.0|-17.8|33.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||33.1|-17.8|
73950595|NCT02564055|147434969|OTHER||Difference in percentages|9.8|||||TWO_SIDED|95.0|-15.5|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||33.9|-15.5|
73950596|NCT02564055|147434969|OTHER||Difference in percentages|5.8|||||TWO_SIDED|95.0|-19.7|30.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||30.5|-19.7|
73950597|NCT02564055|147434969|OTHER||Difference in percentages|17.2|||||TWO_SIDED|95.0|-9.0|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||41.4|-9.0|
73950598|NCT02564055|147434969|OTHER||Difference in percentages|-0.6|||||TWO_SIDED|95.0|-26.0|25.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.|||25.0|-26.0|
73950599|NCT02564055|147434969|OTHER||Difference in percentages|33.3|||||TWO_SIDED|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.|||90.6|-31.9|
73950600|NCT02564055|147434969|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.|||47.8|-62.4|
73950601|NCT02564055|147434969|OTHER||Difference in percentages|28.6|||||TWO_SIDED|95.0|-19.2|71.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.|||71.0|-19.2|
73950602|NCT02564055|147434969|OTHER||Difference in percentages|24.2|||||TWO_SIDED|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.|||80.9|-40.3|
73978220|NCT04837937|147502034|SUPERIORITY||Actual Intercept value|54.9056|STANDARD_ERROR_OF_MEAN|0.5077|<|0.0001||95.0|53.9003|55.9109||this is the Intercept value for the GLMM evaluating all combinations of treatment and time- in other words, this is the mean well-being t-score across all combinations of tx and time. Estimates in these analyses are deviations from this intercept.|Mixed Models Analysis|||Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the intercept (all tx=0).||55.9109|53.9003|<.0001
73978221|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|-0.05579|STANDARD_ERROR_OF_MEAN|0.03516||0.1152||95.0|-0.1254|0.01383||alpha=0.05|Mixed Models Analysis|||Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This test evaluates the effect of time (measured as weeks since baseline).||.01383|-.1254|.1152
73978222|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|-0.03261|STANDARD_ERROR_OF_MEAN|0.03516||0.3555||95.0|-0.1022|0.03699|||Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician treatment arm\*time."||.03699|-.1022|.3555
73978223|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|0.06825|STANDARD_ERROR_OF_MEAN|0.03516||0.0546||95.0|-0.00136|0.1379||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm\*time."||.1379|-.00136|.0546
73950603|NCT02564055|147434970|OTHER||Difference in percentages|5.3|||||TWO_SIDED|95.0|-18.3|28.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||28.4|-18.3|
73950604|NCT02564055|147434970|OTHER||Difference in percentages|5.9|||||TWO_SIDED|95.0|-17.1|28.4|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.|||28.4|-17.1|
73978224|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|0.02597|STANDARD_ERROR_OF_MEAN|0.03516||0.4616||95.0|-0.04364|0.09557||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Physician treatment arm\*time."||.09557|-.04364|.4616
73978225|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|0.0498|STANDARD_ERROR_OF_MEAN|0.03516||0.1592||95.0|-0.0198|0.1194||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Older Adult treatment arm\*time."||.1194|-.0198|.1592
73978226|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|-0.02435|STANDARD_ERROR_OF_MEAN|0.03516||0.4899||95.0|-0.09396|0.04526|||Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician/Older Adult treatment arm\*time."||.04526|-.09396|.4899
73978227|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|0.000697|STANDARD_ERROR_OF_MEAN|0.03516||0.9842||95.0|-0.06891|0.0703||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm\*time."||.0703|-.06891|.9842
73978228|NCT04837937|147502034|SUPERIORITY||Mean Difference (Final Values)|-0.01255|STANDARD_ERROR_OF_MEAN|0.03516||0.7217||95.0|-0.08216|0.05705||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Older Adult/Physician treatment arm\*time."||.05705|-.08216|.7217
73978229|NCT04837937|147502035|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_DEVIATION|6.55||0.21||95.0|-1.9|0.42||Threshold for statistical significance was alpha=0.05.|2-sided paired t-Test|||Univariate ANOVA- analytic variable is change in PROMIS Anxiety score from baseline to T3. Test is a paired T-Test.||.42|-1.90|.21
73950605|NCT02564055|147434970|OTHER||Difference in percentages|-0.8|||||TWO_SIDED|95.0|-24.0|22.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.|||22.7|-24.0|
73871072|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73871073|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.5495|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.5495
73871074|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
73871075|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
73871076|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.4948|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.4948
73871077|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
73871078|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
73871079|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.4663|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.4663
73978230|NCT04837937|147502036|SUPERIORITY||Mean Difference (Final Values)|-3.24|STANDARD_DEVIATION|11.54||0.0021||95.0|-5.28|-1.2||Threshold for significance was 0.05.|2-sided dependent sample t-test|||Univariate ANOVA on change in Zarit Caregiver Burden Score, Baseline to 1-month post-intervention. Test was a 2-sided dependent samples t-test.||-1.20|-5.28|.0021
74032584|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.53|||||TWO_SIDED|95.0|0.95|2.47|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B||2.47|0.95|
73871080|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
73871081|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
73871082|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.9357|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.9357
73871083|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
73871084|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
73871085|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.7439|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.7439
73871086|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73871087|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73871088|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.8611|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.8611
73978231|NCT04837937|147502037|SUPERIORITY||Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|8.1||0.1||95.0|-2.62|0.25||Alpha for statistical significance was 0.05|2-Sided Paired T Test|||Univariate ANOVA- analytic variable is change in PROMIS Fatigue score from baseline to T3. Test is a paired T-Test.||.25|-2.62|.10
73978232|NCT04837937|147502038|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|7.83||0.9754||95.0|-1.36|1.41|||2-sided paired (dependent sample) t-test|||Univariate ANOVA on change in PROMIS short form General Self Efficacy T-Score, baseline to one month post-intervention. Test is a 2-sided paired (dependent sample) t-test.||1.41|-1.36|.9754
73871089|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
73871090|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
73871091|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.6731|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.6731
73871092|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
73871093|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
73871094|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.2616|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.2616
73871095|NCT00445770|147286386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
73871096|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0001
73871097|NCT00445770|147286386|SUPERIORITY_OR_OTHER|||||||0.1158|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1158
73871098|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73978233|NCT04837937|147502040|SUPERIORITY||Mean Difference (Final Values)|0.1296|STANDARD_DEVIATION|4.91||0.77||95.0|-0.74|1.0||Threshold for significance is 0.05|2-sided Paired T-Test|||Univariate ANOVA on change in T-Score between baseline and 1 month post-intervention. Test is a 2-sided paired t-test.||1.00|-.74|.77
73978234|NCT04837937|147502041|SUPERIORITY||Mean Difference (Final Values)|0.7618|STANDARD_DEVIATION|6.16||0.1694||95.0|-0.33|1.85||alpha threshold for significance was 0.05.|two-sided paired T-Test|||Univariate ANOVA on change in T-score between baseline and one month post-intervention. Test is a two-sided paired t-test.||1.85|-.33|.1694
73978235|NCT04837937|147502046|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_DEVIATION|16.44||0.76||||||Alpha for Significance=0.05|ANOVA|||Univariate ANOVA on change in Avoiding Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.76
73978236|NCT04837937|147502046|SUPERIORITY||Mean Difference (Final Values)|2.25|STANDARD_DEVIATION|16.33||0.13||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Compromising Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.13
73978237|NCT04837937|147502046|SUPERIORITY||Mean Difference (Final Values)|-6.85|STANDARD_DEVIATION|18.76|<|0.0001||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Forcing Score (out of 100) between Baseline and 1 Month Post-Intervention.||||<.0001
73978238|NCT04837937|147502046|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|15.62||0.86||||||Alpha for Significance=0.05|ANOVA|||Univariate ANOVA on change in Problem Solving Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.86
73978239|NCT04837937|147502046|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|12.3||0.32||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Yielding Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.32
73978240|NCT04837937|147502047|SUPERIORITY||Mean Difference (Final Values)|3.09|STANDARD_DEVIATION|13.18||0.0012||95.0|||||ANOVA|||Univariate ANOVA on change in total Negotiation Knowledge score, Baseline 1-month. Threshold for significance was alpha=0.05.||||.0012
73978241|NCT04837937|147502047|SUPERIORITY||Mean Difference (Final Values)|4.933|STANDARD_DEVIATION|17.33||0.0018||||||alpha=0.05|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Interests score, Baseline 1-month. Threshold for significance was alpha=0.05.||||.0018
73978242|NCT04837937|147502047|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|19.69||0.91||||||Threshold for significance was alpha=0.05.|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Power score, Baseline 1-month.||||.91
73978243|NCT04837937|147502047|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_DEVIATION|22.35||0.11||||||Threshold for significance was alpha=0.05.|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Rights score, Baseline 1-month.||||.11
73978244|NCT04837937|147502049|SUPERIORITY||Mean Difference (Final Values)|-2.08|STANDARD_DEVIATION|5.73|<|0.0001||95.0|-3.09|-1.07||Threshold for significance is alpha=0.05.|2-sided dependent sample t-test|||Univariate ANOVA on change in negative affect score, baseline-1 month post-intervention. Test is a 2 sided dependent sample t-test.||-1.07|-3.09|<.0001
73978245|NCT04837937|147502049|SUPERIORITY||Mean Difference (Final Values)|0.344|STANDARD_DEVIATION|4.86||0.4305||95.0|-0.52|1.21|||2-sided dependent sample t-test|||Univariate ANOVA of change in positive affect score between baseline-1 month post-intervention. Test is a 2-sided dependent sample t-test.||1.21|-.52|.4305
73978246|NCT04323800|147502066|SUPERIORITY||Risk Difference (RD)|0.01||||0.42|ONE_SIDED|95.0||||One-sided p-value|Restricted Mean Survival Test statistic|||||||0.42
73978247|NCT04323800|147502067|SUPERIORITY||Risk Difference (RD)|-5.0||||0.67|TWO_SIDED|95.0|-31.0|19.0|||Chi-squared|||||19|-31|0.67
73978248|NCT04323800|147502068|SUPERIORITY||Risk Difference (RD)|-47.0||||0.06|TWO_SIDED|95.0|-100.0|2.0|||Chi-squared|||||2|-100|0.06
73978249|NCT01303796|147502158|SUPERIORITY||Hazard Ratio (HR)|1.013|||<|0.0249|TWO_SIDED|95.0|0.837|1.226||one-sided|Kaplan-Meier|||The phase III part planned to randomize 485 patients, about 243 per arm (actual 241 patients per arm), over an estimated period of 24 months. Final analysis would occur at approximately 424 deaths, which was expected to be observed about 43 months after the accrual of the first patient. A stratified log rank analysis would have 90% power to detect a 27.5% reduction in the risk of death, i.e., a hazard ratio of 0.725, between Arm A and Arm C.||1.226|0.837|<0.0249
73978250|NCT01303796|147502158|SUPERIORITY||Cox Proportional Hazard|1.08|||<|0.0249|TWO_SIDED|95.0|0.86|1.35||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Presence of antecedent MDS or MPD (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: No (i.e., de novo) vs Presence of antecedent MDS or MPD"||1.35|0.86|<0.0249
73978251|NCT01303796|147502158|SUPERIORITY|Effects of treatments compared in AML patients with baseline WBC count ≥ 10 x 109/L vs WBC count ≤ 10 x 109/L|Cox Proportional Hazard|1.57|||<|0.0249|TWO_SIDED|95.0|1.12|2.19||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Baseline peripheral WBC count ≥ 10 x 109/L (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline WBC count ≥ 10 x 109/L vs WBC count ≤ 10 x 109/L"||2.19|1.12|<0.0249
73978252|NCT01303796|147502158|SUPERIORITY||Cox Proportional Hazard|1.01|||<|0.0249|TWO_SIDED|95.0|0.77|1.32||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Baseline bone marrow blast percentage ≥ 50% (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline bone marrow blast percentage ≥ 50% vs Blast percentage ≤ 50%"||1.32|0.77|<0.0249
73978253|NCT01303796|147502158|SUPERIORITY||Cox Proportional Hazard|1.27|||<|0.0249|TWO_SIDED|95.0|0.94|1.73|||Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Unfavorable cytogenetics risk by SWOG (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Unfavorable cytogenetics vs other"||1.73|0.94|<0.0249
73871099|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73871100|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.4237|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.4237
73871101|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73871102|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0002
73871103|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.5738|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.5738
73871104|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73978254|NCT01303796|147502158|SUPERIORITY||Cox Proportional Hazard|1.222|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Region (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: EU vs US"||||<0.0249
73978255|NCT01303796|147502158|SUPERIORITY||Cox Proportional Hazard|1.071|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Age (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: ≥ 75 years old vs ≤ 75 years old"||||<0.0249
73871105|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73871106|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.1606|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.1606
73871107|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
73871108|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0016
73871109|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.2412|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.2412
73871110|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
73950606|NCT02564055|147434970|OTHER||Difference in percentages|11.4|||||TWO_SIDED|95.0|-12.0|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.|||33.9|-12.0|
73978256|NCT01303796|147502158|SUPERIORITY||Cox Proportional Hazard|0.956|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Gender (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Male vs Female"||||<0.0249
74039481|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.73|-1.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-1.16|-2.73|<.0001
73871111|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
73871112|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.5882|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.5882
73871113|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
73950607|NCT02564055|147434970|OTHER||Difference in percentages|30.2|||||TWO_SIDED|95.0|6.8|51.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.|||51.0|6.8|
73871114|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0001
73871115|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.2257|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.2257
73871116|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
73871117|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0003
73871118|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.2075|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2075
73871119|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73950608|NCT02564055|147434970|OTHER||Difference in percentages|3.7|||||TWO_SIDED|95.0|-19.4|26.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.|||26.6|-19.4|
73950609|NCT02564055|147434970|OTHER||Difference in percentages|17.4|||||TWO_SIDED|95.0|-6.0|39.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.|||39.5|-6.0|
73950610|NCT02564055|147434970|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-7.1|39.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.|||39.4|-7.1|
73950611|NCT02564055|147434970|OTHER||Difference in percentages|41.9|||||TWO_SIDED|95.0|19.2|61.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.|||61.2|19.2|
73978257|NCT01303796|147502158|SUPERIORITY||||||<|0.0249||||||one-sided|Log Rank|Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.||"Subgroup analyses (post-hoc): ECOG status (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Status 2 vs \< 2"||||<0.0249
73950612|NCT02564055|147434970|OTHER||Difference in percentages|8.9|||||TWO_SIDED|95.0|-14.9|32.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.|||32.0|-14.9|
73950613|NCT02564055|147434970|OTHER||Difference in percentages|16.3|||||TWO_SIDED|95.0|-7.3|38.3|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.|||38.3|-7.3|
73950614|NCT02564055|147434970|OTHER||Difference in percentages|13.4|||||TWO_SIDED|95.0|-11.3|36.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.|||36.5|-11.3|
73950615|NCT02564055|147434970|OTHER||Difference in percentages|30.8|||||TWO_SIDED|95.0|6.1|52.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.|||52.8|6.1|
73950616|NCT02564055|147434970|OTHER||Difference in percentages|21.9|||||TWO_SIDED|95.0|-3.0|44.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.|||44.9|-3.0|
73950617|NCT02564055|147434970|OTHER||Difference in percentages|10.9|||||TWO_SIDED|95.0|-13.5|34.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.|||34.7|-13.5|
73950618|NCT02564055|147434970|OTHER||Difference in percentages|27.4|||||TWO_SIDED|95.0|2.5|49.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||49.9|2.5|
73950619|NCT02564055|147434970|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-9.0|40.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||40.7|-9.0|
73950620|NCT02564055|147434970|OTHER||Difference in percentages|29.5|||||TWO_SIDED|95.0|3.7|52.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||52.3|3.7|
73950621|NCT02564055|147434970|OTHER||Difference in percentages|5.7|||||TWO_SIDED|95.0|-20.1|30.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||30.9|-20.1|
73950622|NCT02564055|147434970|OTHER||Difference in percentages|9.3|||||TWO_SIDED|95.0|-16.2|33.8|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||33.8|-16.2|
73950623|NCT02564055|147434970|OTHER||Difference in percentages|12.6|||||TWO_SIDED|95.0|-13.4|37.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||37.3|-13.4|
73950624|NCT02564055|147434970|OTHER||Difference in percentages|27.0|||||TWO_SIDED|95.0|0.7|50.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||50.5|0.7|
73950625|NCT02564055|147434970|OTHER||Difference in percentages|0.4|||||TWO_SIDED|95.0|-25.6|25.6|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||25.6|-25.6|
73950626|NCT02564055|147434970|OTHER||Difference in percentages|2.6|||||TWO_SIDED|95.0|-22.6|27.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||27.6|-22.6|
73950627|NCT02564055|147434970|OTHER||Difference in percentages|6.9|||||TWO_SIDED|95.0|-18.7|31.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||31.7|-18.7|
73950628|NCT02564055|147434970|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-9.5|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||41.4|-9.5|
73950629|NCT02564055|147434970|OTHER||Difference in percentages|10.9|||||TWO_SIDED|95.0|-14.9|35.8|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.|||35.8|-14.9|
73950630|NCT02564055|147434970|OTHER||Difference in percentages|33.3|||||TWO_SIDED|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.|||90.6|-31.9|
73950631|NCT02564055|147434970|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.|||47.8|-62.4|
73950632|NCT02564055|147434970|OTHER||Difference in percentages|14.3|||||TWO_SIDED|95.0|-32.2|57.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.|||57.9|-32.2|
73950633|NCT02564055|147434970|OTHER||Difference in percentages|24.2|||||TWO_SIDED|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.|||80.9|-40.3|
73950634|NCT02564055|147434977|OTHER||Difference in percentages|-7.7|||||TWO_SIDED|95.0|-45.8|32.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||32.5|-45.8|
73950635|NCT02564055|147434977|OTHER||Difference in percentages|15.4|||||TWO_SIDED|95.0|-25.7|52.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 1 has been presented.|||52.6|-25.7|
73950636|NCT02564055|147434977|OTHER||Difference in percentages|-7.7|||||TWO_SIDED|95.0|-46.0|32.6|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 1 has been presented.|||32.6|-46.0|
73950637|NCT02564055|147434977|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-32.2|48.8|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 1 has been presented.|||48.8|-32.2|
73950638|NCT02564055|147434977|OTHER||Difference in percentages|-24.2|||||TWO_SIDED|95.0|-60.8|14.8|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 2 has been presented.|||14.8|-60.8|
73950639|NCT02564055|147434977|OTHER||Difference in percentages|28.5|||||TWO_SIDED|95.0|-13.7|63.0|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 2 has been presented.|||63.0|-13.7|
73950640|NCT02564055|147434977|OTHER||Difference in percentages|-33.3|||||TWO_SIDED|95.0|-67.4|6.1|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 2 has been presented.|||6.1|-67.4|
73950641|NCT02564055|147434977|OTHER||Difference in percentages|-0.9|||||TWO_SIDED|95.0|-40.7|40.7|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 2 has been presented.|||40.7|-40.7|
73950642|NCT02564055|147434977|OTHER||Difference in percentages|-15.2|||||TWO_SIDED|95.0|-53.8|23.5|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 4 has been presented.|||23.5|-53.8|
73950643|NCT02564055|147434977|OTHER||Difference in percentages|43.4|||||TWO_SIDED|95.0|2.7|74.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 4 has been presented.|||74.6|2.7|
73950644|NCT02564055|147434977|OTHER||Difference in percentages|-15.2|||||TWO_SIDED|95.0|-53.8|23.5|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 4 has been presented.|||23.5|-53.8|
73950645|NCT02564055|147434977|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 4 has been presented.|||51.2|-35.6|
73950646|NCT02564055|147434977|OTHER||Difference in percentages|18.3|||||TWO_SIDED|95.0|-25.1|57.1|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 8 has been presented.|||57.1|-25.1|
73871120|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0050
73871121|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.0461|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0461
73950647|NCT02564055|147434977|OTHER||Difference in percentages|47.7|||||TWO_SIDED|95.0|4.8|78.7|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 8 has been presented.|||78.7|4.8|
73950648|NCT02564055|147434977|OTHER||Difference in percentages|-11.7|||||TWO_SIDED|95.0|-51.3|30.2|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 8 has been presented.|||30.2|-51.3|
73950649|NCT02564055|147434977|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 8 has been presented.|||51.2|-35.6|
73950650|NCT02564055|147434977|OTHER||Difference in percentages|6.4|||||TWO_SIDED|95.0|-35.4|48.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||48.5|-35.4|
73950651|NCT02564055|147434977|OTHER||Difference in percentages|6.0|||||TWO_SIDED|95.0|-35.8|47.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||47.1|-35.8|
73950652|NCT02564055|147434977|OTHER||Difference in percentages|-13.6|||||TWO_SIDED|95.0|-54.0|31.2|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||31.2|-54.0|
73950653|NCT02564055|147434977|OTHER||Difference in percentages|-25.6|||||TWO_SIDED|95.0|-65.3|22.4|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||22.4|-65.3|
73950654|NCT02564055|147434977|OTHER||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||42.7|-44.5|
73978258|NCT01303796|147502158|SUPERIORITY||||||<|0.0249||||||one-sided|Log Rank|Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.||"Subgroup analyses (post-hoc): HCT-CI score (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: HCT-CI score 0-2 vs HCT-CI score \>2"||||<0.0249
73978259|NCT01303796|147502159|SUPERIORITY||Cox Proportional Hazard|1.34||||0.1468|TWO_SIDED|95.0|0.645|2.782|||Fisher Exact|||||2.782|0.645|0.1468
73871122|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0002
73950655|NCT02564055|147434977|OTHER||Difference in percentages|5.6|||||TWO_SIDED|95.0|-37.8|47.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||47.3|-37.8|
73950656|NCT02564055|147434977|OTHER||Difference in percentages|-5.5|||||TWO_SIDED|95.0|-47.9|37.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||37.6|-47.9|
73950657|NCT02564055|147434977|OTHER||Difference in percentages|-4.4|||||TWO_SIDED|95.0|-48.3|41.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||41.5|-48.3|
73950658|NCT02564055|147434977|OTHER||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||42.7|-44.5|
73950659|NCT02564055|147434977|OTHER||Difference in percentages|8.3|||||TWO_SIDED|95.0|-35.0|49.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||49.2|-35.0|
73950660|NCT02564055|147434977|OTHER||Difference in percentages|-3.3|||||TWO_SIDED|95.0|-46.0|42.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||42.3|-46.0|
73950661|NCT03268590|147435030|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
73978260|NCT01303796|147502164|SUPERIORITY|||||||0.0416|||||||Wilcoxon (Mann-Whitney)|||||||0.0416
73978261|NCT01303796|147502165|SUPERIORITY|||||||0.1568|||||||Wilcoxon (Mann-Whitney)|||||||0.1568
73871123|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.0101|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0101
73871124|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.2351|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.2351
73950662|NCT03268590|147435031|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
73950663|NCT03268590|147435032|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
73950664|NCT02971891|147435042|SUPERIORITY|||||||0.1789|||||||Cochran-Mantel-Haenszel|||||||0.1789
73950665|NCT03954158|147435090|SUPERIORITY||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.53||0.0071|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures (MMRM) included the fixed effect of visit, and the covariance structure UN was used.||-0.5|-2.7|0.0071
73950666|NCT03954158|147435090|SUPERIORITY||Least squares mean of difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.0029|TWO_SIDED|95.0|-3.3|-0.8|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.8|-3.3|0.0029
73950667|NCT03954158|147435090|SUPERIORITY||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.025|TWO_SIDED|95.0|-2.7|-0.2|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.7|0.0250
73950668|NCT03954158|147435090|SUPERIORITY||Least squares mean of difference|-2.1|STANDARD_ERROR_OF_MEAN|0.56||0.0014|TWO_SIDED|95.0|-3.3|-0.9|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.9|-3.3|0.0014
73950669|NCT03954158|147435091|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.4295|||TWO_SIDED|95.0|-2.0|0.9||||||Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.9|-2.0|
73950670|NCT03954158|147435091|OTHER||Difference of least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.1|0.4||||||Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.4|-2.1|
73978262|NCT01303796|147502166|SUPERIORITY||Cox Proportional Hazard|1.013|||<|0.0249|TWO_SIDED|95.0|0.837|1.226||one-sided|Log Rank|||||1.226|0.837|<0.0249
73871125|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0002
73978263|NCT02148705|147502173|SUPERIORITY||Odds Ratio (OR)|288.281|||<|0.0001|TWO_SIDED|95.0|35.549|13984.356|||Fisher Exact|||||13984.356|35.549|<0.0001
73978264|NCT02148705|147502174|SUPERIORITY||Odds Ratio (OR)|0.011|||<|0.0001|TWO_SIDED|95.0|0.003|0.044|||Chi-squared|||||0.044|0.003|<0.0001
73978265|NCT02148705|147502175|SUPERIORITY||Test Statistics|23.1429|||<|0.0001|TWO_SIDED||||||Generalized Wilcoxon-Gehan Test|Analysis is adjusted for Overall TW Depths, TBSA Group, Center Group, and Number of TWs||||||<0.0001
73978266|NCT02148705|147502176|SUPERIORITY||estimate|6505.8|STANDARD_ERROR_OF_MEAN|269.88|<|0.0001|TWO_SIDED|95.0|5974.41|7037.19|||Wilcoxon (Mann-Whitney)|Wilcoxon tests pooled using Rubin´s rule||||7037.19|5974.41|<0.0001
73978267|NCT01009645|147502221|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The first contrast assessed whether or not the three newly created messages (Fact Only (FO), Fact/Myth (FM), and Fact/Myth/Refutation (FMR)) were as a group significantly different than the control message.||||<0.05
73978268|NCT01009645|147502221|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The second contrast assessed whether the FO and FMR conditions were significantly different from the FM message.||||<0.05
73978269|NCT01009645|147502221|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The third contrast assessed whether the FO and the FMR message conditions were significantly different.||||<0.05
73978270|NCT01009645|147502222|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||ANOVA|used Scheffe's post-hoc analysis||||||<0.05
73978271|NCT00768755|147502264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.831||||0.3037|TWO_SIDED|95.0|0.508|1.36|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1) and gender (male or female). Hazard ratio (HR): the stratified Cox model was fitted, using the same stratification variables as above.||1.360|0.508|0.3037
73978272|NCT00768755|147502264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947||||0.3565|TWO_SIDED|95.0|0.58|1.546|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||1.546|0.580|0.3565
73978273|NCT00768755|147502265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046||||0.5785|TWO_SIDED|95.0|0.648|1.69|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||1.690|0.648|0.5785
73978274|NCT00768755|147502265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.449||||0.9392|TWO_SIDED|95.0|0.919|2.285|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||2.285|0.919|0.9392
73978275|NCT00768755|147502266|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.753||||0.0143|TWO_SIDED|95.0|1.047|2.935|||Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test stratified by ECOG performance status (0 or 1) and gender (male or female).||2.935|1.047|0.0143
73978276|NCT00768755|147502266|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.512||||0.0665|TWO_SIDED|95.0|0.87|2.626|||Cochran-Mantel-Haenszel|||P-value was calculated using CMH test stratified by ECOG performance status (0 or 1) and gender (male or female).||2.626|0.870|0.0665
73978277|NCT03052517|147502274|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.74|1.0|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.00|0.74|
73978278|NCT03052517|147502274|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.72|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.72|
73978279|NCT03052517|147502274|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.87|1.09|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.09|0.87|
73978280|NCT03052517|147502275|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.02|0.76|
73871126|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.1179|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.1179
73871127|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.0214|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0214
73871128|NCT00445770|147286387|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
73871129|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0790
73950671|NCT03954158|147435092|OTHER||Least squares mean of difference|-1.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-3.1|-0.7||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.7|-3.1|
73950672|NCT03954158|147435092|OTHER||Least squares mean of difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-2.7|-0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.7|
73950673|NCT03954158|147435092|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.2|-0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.2|
73950674|NCT03954158|147435092|OTHER||Least squares mean of difference|-1.7|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-2.8|-0.5||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.5|-2.8|
73978281|NCT03052517|147502275|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.73|0.99|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.99|0.73|
73978282|NCT03052517|147502275|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.86|1.08|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.08|0.86|
73978283|NCT03052517|147502276|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.51|1.22|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.22|0.51|
73978284|NCT03052517|147502276|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.39|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.39|
73978285|NCT03052517|147502276|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.54|1.14|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.14|0.54|
73978286|NCT03052517|147502277|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.22|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.22|0.54|
73978287|NCT03052517|147502277|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.41|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.41|
73978288|NCT03052517|147502277|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.55|1.11|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.11|0.55|
73950675|NCT03954158|147435092|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.5|1.3||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||1.3|-1.5|
73950676|NCT03954158|147435092|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.2|1.0||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||1.0|-1.2|
73950677|NCT03954158|147435093|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.9|-0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.1|-0.9|
73978289|NCT03052517|147502278|OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.47|2.23|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||2.23|0.47|
74089358|NCT02697773|147731616|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1995|TWO_SIDED|95.0|0.85|2.16|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|0.85|0.1995
73871130|NCT00445770|147286387|SUPERIORITY_OR_OTHER|||||||0.0168|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0168
73871131|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73950678|NCT03954158|147435093|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.9|0.0||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-0.9|
73950679|NCT03954158|147435093|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-0.8|0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.1|-0.8|
73950680|NCT03954158|147435093|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.8|0.0||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-0.8|
73871132|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73871133|NCT00445770|147286388|SUPERIORITY_OR_OTHER|||||||0.6337|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.6337
73871134|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73871135|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73871136|NCT00445770|147286388|SUPERIORITY_OR_OTHER|||||||0.7407|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.7407
73871137|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73871138|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73871139|NCT00445770|147286388|SUPERIORITY_OR_OTHER|||||||0.3473|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.3473
73871140|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
73978290|NCT03052517|147502278|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.59|2.64|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||2.64|0.59|
73871141|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
73871142|NCT00445770|147286388|SUPERIORITY_OR_OTHER|||||||0.7529|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.7529
73871143|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
73871144|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
73871145|NCT00445770|147286388|SUPERIORITY_OR_OTHER|||||||0.5216|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.5216
73871146|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
73871147|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
73871148|NCT00445770|147286388|SUPERIORITY_OR_OTHER|||||||0.1078|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.1078
73871149|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
73871150|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
73871151|NCT00445770|147286388|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.1280
73871152|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73871153|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73871154|NCT00445770|147286388|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0291
73871155|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
73871156|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
73871157|NCT00445770|147286388|SUPERIORITY_OR_OTHER|||||||0.0729|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0729
73871158|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
73871159|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
73871160|NCT00445770|147286388|SUPERIORITY_OR_OTHER|||||||0.0271|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0271
73871161|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
73871162|NCT00445770|147286388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
73978291|NCT03052517|147502278|OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|2.1|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||2.10|0.70|
73871163|NCT00445770|147286388|SUPERIORITY_OR_OTHER|||||||0.0453|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0453
73871164|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73950681|NCT03954158|147435093|OTHER||Difference of least square mean|0.1|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.4|0.6||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.6|-0.4|
73950682|NCT03954158|147435093|OTHER||Difference of least square mean|0.2|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.3|0.7||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.7|-0.3|
73950683|NCT03954158|147435093|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-1.4|-0.4||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.4|-1.4|
73950684|NCT03954158|147435093|OTHER||Least squares mean of difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|-1.2|-0.2||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-1.2|
73978292|NCT03052517|147502279|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.56|2.56|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||2.56|0.56|
73978293|NCT03052517|147502279|OTHER||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.67|2.95|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||2.95|0.67|
73978294|NCT03052517|147502279|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.7|1.96|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.96|0.70|
73978295|NCT03052517|147502280|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.626|1.047|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo||1.047|0.626|
73978296|NCT03052517|147502280|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.622|1.038|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo||1.038|0.622|
73978297|NCT03052517|147502280|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.821|1.2|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg||1.200|0.821|
73978298|NCT03052517|147502281|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.667|1.125|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo||1.125|0.667|
73871165|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73871166|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.7488|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.7488
73871167|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73871168|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73950685|NCT03954158|147435093|OTHER||Least squares mean of difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-1.2|-0.2||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-1.2|
73871169|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.568|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.5680
73871170|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73871171|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73950686|NCT03954158|147435093|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-1.4|-0.6||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.6|-1.4|
73950687|NCT03954158|147435093|OTHER||Difference of least square mean|0.0|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.5|0.6||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.6|-0.5|
73950688|NCT03954158|147435093|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.7|0.5||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.5|-0.7|
73978299|NCT03052517|147502281|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.643|1.082|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo||1.082|0.643|
73871172|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.9241|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.9241
74032585|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.41|1.34|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F||1.34|0.41|
73950689|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.0|-0.2||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.2|-1.0|
73950690|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.7|0.5||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.5|-0.7|
73950691|NCT03954158|147435094|OTHER||Difference of least squares mean|0.6|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.5|1.7||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.7|-0.5|
73950692|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-1.3|0.1||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.1|-1.3|
73950693|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.9|0.4||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.4|-0.9|
73950694|NCT03954158|147435094|OTHER||Difference of least square mean|0.2|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-0.9|1.3||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.3|-0.9|
73950695|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.1|-0.5||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-2.1|
73950696|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.5|-0.1||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.5|
73950697|NCT03954158|147435094|OTHER||Difference of least square mean|0.4|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.6|1.4||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.4|-0.6|
73950698|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.9|-0.3||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-1.9|
73950699|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.5|-0.1||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.5|
73950700|NCT03954158|147435094|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.1|1.0||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.0|-1.1|
73950701|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.1|-0.4||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.4|-2.1|
73950702|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-1.1|0.4||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.4|-1.1|
73871173|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
73950703|NCT03954158|147435094|OTHER||Difference of least square mean|0.5|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.6|1.5||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.5|-0.6|
73950704|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.3|-0.1||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.3|
73950705|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-1.0|0.2||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.2|-1.0|
73950706|NCT03954158|147435094|OTHER||Difference of least square mean|0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-0.6|1.3||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.3|-0.6|
74032586|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.73|||||TWO_SIDED|95.0|0.34|1.57|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V||1.57|0.34|
74032587|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.44|||||TWO_SIDED|95.0|0.16|1.18|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 14||1.18|0.16|
74032588|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.59|||||TWO_SIDED|95.0|0.25|1.4|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C||1.40|0.25|
74032589|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.79|||||TWO_SIDED|95.0|0.5|1.23|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A||1.23|0.50|
74032590|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.14|||||TWO_SIDED|95.0|0.6|2.18|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F||2.18|0.60|
74032591|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.08|||||TWO_SIDED|95.0|0.68|1.72|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F||1.72|0.68|
74032592|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|10.3|||||TWO_SIDED|95.0|2.44|43.49|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1||43.49|2.44|
73871174|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
73871175|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.7146|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.7146
73978300|NCT03052517|147502281|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.794|1.167|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg||1.167|0.794|
73978301|NCT00659373|147502372|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.71
73978302|NCT02356198|147502381|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
74032593|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.17|||||TWO_SIDED|95.0|2.07|18.42|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 3||18.42|2.07|
74032594|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|18.7|||||TWO_SIDED|95.0|4.35|80.37|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 4||80.37|4.35|
74039482|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.37||0.0385|TWO_SIDED|95.0|-1.47|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-1.47|0.0385
73871176|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
73871177|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0001
73871178|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.6574|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.6574
73978303|NCT02356198|147502382|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||||||0.102
73978304|NCT02356198|147502383|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
73978305|NCT02356198|147502384|SUPERIORITY|||||||0.454|||||||Chi-squared|||||||0.454
73978306|NCT02356198|147502385|SUPERIORITY|||||||0.212|||||||Fisher Exact|||||||0.212
73978307|NCT03162614|147502390|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|TWO_SIDED|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (AduFx Group versus Control Group).||72|27|<.001
73978308|NCT03162614|147502390|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|76.0|||<|0.001|TWO_SIDED|95.0|49.0|89.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as double full doses at Month 0 and Month 1 and 1/5th double dose at Month 7 (2Ped Fx Group versus Control Group).||89|49|<.001
73978309|NCT03162614|147502390|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|64.0|||<|0.001|TWO_SIDED|95.0|37.0|79.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (PedFx Group versus Control Group).||79|37|<.001
73978310|NCT03162614|147502390|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|TWO_SIDED|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 1 and Month 7 (Adu2Fx Group versus Control Group).||72|27|<.001
73978311|NCT03162614|147502390|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|29.0||||0.009|TWO_SIDED|95.0|6.0|46.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 7 (Adu1Fx Group versus Control Group).||46|6|0.009
73978312|NCT00556478|147502437|SUPERIORITY_OR_OTHER||Ratio (over 3 months/Baseline)|3.05|||<|0.0001|TWO_SIDED|95.0|2.29|4.06|||ANCOVA|||||4.06|2.29|<0.0001
73978313|NCT00556478|147502438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||<|0.0001|TWO_SIDED|95.0|3.61|6.34|||ANCOVA|||Analysis of IPE domain ejaculatory control||6.34|3.61|<0.0001
73978314|NCT00556478|147502438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|||<|0.0001|TWO_SIDED|95.0|3.3|5.84|||ANCOVA|||IPE domain sexual satisfaction||5.84|3.30|<0.0001
73978315|NCT00556478|147502438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.86|3.2|||ANCOVA|||IPE domain distress||3.20|1.86|<0.0001
73978316|NCT05270460|147502447|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0||||Adjustment for multiple comparisons were made using Dunnett's test at the overall alpha = 0.05 significance level|ANCOVA|Fixed effects for treatment group (PCS12852 0.1 mg, PCS12852 0.5 mg, and Placebo) and type (IG or DG) and the baseline value as a continuous covariate||||||<0.05
73978317|NCT05270460|147502448|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|Fixed effects for treatment group (PCS12852 0.1 mg, PCS12852 0.5 mg, and Placebo) and type (IG or DG) and the baseline value as a continuous covariate||||||<0.05
73978318|NCT05270460|147502449|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
73978319|NCT05270460|147502450|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
73978320|NCT05270460|147502451|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
73978321|NCT05270460|147502452|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
73978322|NCT05270460|147502453|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
73978323|NCT05270460|147502454|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
73978324|NCT05270460|147502455|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
73978325|NCT05270460|147502456|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
73978326|NCT00380250|147502457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117|||||||van Elteren nonparametric test|Adjusted for center||||||0.117
73978327|NCT00380250|147502458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||van Elteren nonparametric test|Adjusted for center||||||0.006
73978328|NCT00380250|147502459|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||van Elteren nonparametric test|Adjusted for center||||||0.050
73978329|NCT00380250|147502460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.159|||||||van Elteren nonparametric test|Adjusted for center||||||0.159
73978330|NCT00380250|147502461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.378|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.378
73978331|NCT00380250|147502462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.588|||||||ANCOVA|Adjusted for clinical site||||||0.588
73978332|NCT00380250|147502463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||90% statistical power to detect 70.6% improvement in response with lubiprostone||||0.029
73978333|NCT00380250|147502464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.028
73978334|NCT00380250|147502465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.069
73978335|NCT00380250|147502466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.098
73978336|NCT00380250|147502467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.286|||||||van Elteren nonparametric test|Adjusted for center||||||0.286
73978337|NCT00380250|147502468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.337|||||||van Elteren nonparametric test|Adjusted for center||||||0.337
73871179|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
73871180|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0004
73871181|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.2936|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.2936
73871182|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
73950707|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-2.0|-0.3||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-2.0|
73950708|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.3|0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.1|-1.3|
73950709|NCT03954158|147435094|OTHER||Difference of least square mean|0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.6|1.2||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.2|-0.6|
73950710|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.7|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.4|-0.9||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.9|-2.4|
73950711|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.5|0.7||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.7|-1.5|
73950712|NCT03954158|147435094|OTHER||Difference of least square mean|0.5|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-0.7|1.6||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.6|-0.7|
73950713|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-2.3|-0.9||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.9|-2.3|
73950714|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.1|-0.1||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.1|
73978338|NCT00380250|147502469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.334|||||||van Elteren nonparametric test|Adjusted for center||||||0.334
73978339|NCT00380250|147502470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||van Elteren nonparametric test|Adjusted for center||||||0.242
73871183|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0005
73871184|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2179
73871185|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73871186|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73871187|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.3704|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.3704
73871188|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
73950715|NCT03954158|147435094|OTHER||Difference of Least Squares Mean|0.2|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-0.8|1.2||||||Change at Day 10, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.2|-0.8|
73950716|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.7|0.0||||||Change at Day 11, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.0|-1.7|
73950717|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.3|-0.7||||||Change at Day 11, Intra-participant: MMRM included the fixed effect of day, and the covariance structure UN was used.||-0.7|-2.3|
73950718|NCT03954158|147435094|OTHER||Difference of Least Squares Mean|0.2|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.7|1.1||||||Change at Day 11, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.1|-0.7|
73950719|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-2.0|-0.5||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-2.0|
73978340|NCT00380250|147502471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||van Elteren nonparametric test|Adjusted for center||||||0.030
73978341|NCT00380250|147502472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||van Elteren nonparametric test|Adjusted for center||||||0.130
73978342|NCT00380250|147502473|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||van Elteren nonparametric test|Adjusted for center||||||0.049
73978343|NCT00380250|147502474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.348|||||||van Elteren nonparametric test|Adjusted for center||||||0.348
73950720|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.0|-2.0|
73950721|NCT03954158|147435094|OTHER||Difference of Least Squares Mean|0.1|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-0.9|1.2||||||Change at Day 12, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.2|-0.9|
73950722|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.8|-0.3||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-1.8|
73950723|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.0|-0.1||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.0|
73950724|NCT03954158|147435094|OTHER||Difference of Least Squares Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.3|0.9||||||Change at Day 13, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||0.9|-1.3|
73950725|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.9|-0.5||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-1.9|
73950726|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.8|-0.1||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.8|
73950727|NCT03954158|147435094|OTHER||Difference of Least Squares Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.5|0.7||||||Change at Day 14, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||0.7|-1.5|
73978344|NCT00380250|147502475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064|||||||van Elteren nonparametric test|Adjusted for center||||||0.064
73978345|NCT00380250|147502476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111|||||||van Elteren nonparametric test|||||||0.111
73978346|NCT00380250|147502477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.144|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.144
73978347|NCT00380250|147502478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.168|||||||Cochran-Mantel-Haenszel|Adjusted by pooled center||||||0.168
73978348|NCT00380250|147502479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615|||||||van Elteren nonparametic test|Adjusted for center||||||0.615
73950728|NCT03954158|147435094|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-2.2|-0.8||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.8|-2.2|
73950729|NCT03954158|147435094|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.5|0.0||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-1.5|
73950730|NCT03954158|147435094|OTHER||Difference of least square mean|-0.3|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.4|0.8||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||0.8|-1.4|
73950731|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.0|0.2||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.2|-1.0|
73950732|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.1|0.5||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.1|
73950733|NCT03954158|147435095|OTHER||Difference of least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.5|1.1||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.1|-0.5|
73950734|NCT03954158|147435095|OTHER||Least squares mean of difference|0.1|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.6|0.7||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-0.6|
73978349|NCT00380250|147502480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.108|||||||van Elteren nonparametric test|||||||0.108
73978350|NCT00380250|147502481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|||||||van Elteren nonparametric test|||||||0.483
73978351|NCT00380250|147502482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.491|||||||van Elteren nonparametric test|||||||0.491
73978352|NCT00380250|147502483|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
73978353|NCT00380250|147502484|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
73978354|NCT00380250|147502485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
73978355|NCT02157948|147502495|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Testing: The lower bound of the 2-sided 95% CI of the between-group difference (denosumab CP4 - denosumab CP2) in percent change from baseline in lumbar spine BMD at 12 months was compared with the non-inferiority margin of -1.44% for assessing non-inferiority.|Difference from CP2|-0.07|||<|0.001|TWO_SIDED|95.0|-0.72|0.57||One-sided p-value based on the prespecified non-inferiority margin of -1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 - denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).||0.57|-0.72|< 0.001
73950735|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
73950736|NCT03954158|147435095|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.0|0.5||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.0|
73871189|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
73978356|NCT02157948|147502495|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Testing: The lower and upper bounds of the same 2-sided 95% CI of the between-group difference were compared with the equivalence margin of ±1.44% for assessing equivalence.|Difference from CP2|-0.07|||<|0.001|TWO_SIDED|95.0|-0.72|0.57||Two-sided p-value based on the prespecified equivalence margin of ±1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 - denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).||0.57|-0.72|< 0.001
73950737|NCT03954158|147435095|OTHER||Least squares mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|96.0|-1.1|1.1||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.1|-1.1|
73978357|NCT01604824|147502498|SUPERIORITY||LS Mean Difference|-53.72|STANDARD_ERROR_OF_MEAN|11.486|=|0.0009|TWO_SIDED|95.0|-79.31|-28.12||Threshold for significance ≤ 0.05|ANCOVA|||||-28.12|-79.31|= 0.0009
73978358|NCT01604824|147502498|SUPERIORITY||LS Mean Difference|-43.28|STANDARD_ERROR_OF_MEAN|10.965|=|0.0056|TWO_SIDED|95.0|-69.21|17.35||Threshold for significance ≤ 0.05|ANCOVA|||||17.35|-69.21|= 0.0056
73950738|NCT03954158|147435095|OTHER||Least squares mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.8|-0.8|
73950739|NCT03954158|147435095|OTHER||Difference of least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-0.9|0.8||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.9|
73950740|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.2|0.3||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-1.2|
73950741|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.4||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.4|-1.2|
73950742|NCT03954158|147435095|OTHER||Difference of least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.8|1.0||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.0|-0.8|
73950743|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.2|0.6||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.6|-1.2|
73978359|NCT01604824|147502499|SUPERIORITY||LS Mean Difference|-49.55|STANDARD_ERROR_OF_MEAN|12.05|=|0.0021|TWO_SIDED|95.0|-76.39|-22.7||Threshold for significance ≤ 0.05|ANCOVA|||LS means (SE), mean difference, 95% CI, and p-values were derived from ANCOVA with treatment group as factor and baseline as covariate.||-22.7|-76.39|= 0.0021
73871190|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.8047|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.8047
73950744|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.9|0.7||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.7|-0.9|
73950745|NCT03954158|147435095|OTHER||Difference of least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.5|0.8||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.5|
73950746|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-1.0|0.9||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.9|-1.0|
73950747|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.7||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.7|-1.0|
73950748|NCT03954158|147435095|OTHER||Difference of least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.2|
73871191|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
73950749|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.3|0.5||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-1.3|
73950750|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.4|0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.4|
73871192|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
73950751|NCT03954158|147435095|OTHER||Difference of least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.5|0.8||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.5|
73950752|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.2|0.6||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.6|-1.2|
73950753|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.4||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.4|-1.2|
73950754|NCT03954158|147435095|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-1.2|0.1||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.1|-1.2|
73950755|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.3|0.7||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-1.3|
73978360|NCT01604824|147502499|SUPERIORITY||LS Mean Difference|-44.64|STANDARD_ERROR_OF_MEAN|10.876|=|0.0045|TWO_SIDED|95.0|-70.36|18.92||Threshold for significance ≤ 0.05|ANCOVA|||LS means (SE), mean difference, 95% CI, and p-values were derived from ANCOVA with treatment group as factor and baseline as covariate.||18.92|-70.36|= 0.0045
73950756|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.6|-1.0|
73950757|NCT03954158|147435095|OTHER||Difference of least squares mean|-0.1|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.8|0.5||||||Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-0.8|
73950758|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.6|0.3||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-1.6|
73950759|NCT03954158|147435095|OTHER||Difference of least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-0.4|1.0||||||Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.0|-0.4|
73950760|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 11, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.2|
73950761|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-1.9|0.0||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-1.9|
73978361|NCT01604824|147502500|SUPERIORITY||LS Mean Difference|-49.37|STANDARD_ERROR_OF_MEAN|11.487|=|0.0016|TWO_SIDED|95.0|-74.96|-23.77||Threshold for significance ≤ 0.05|ANCOVA|||||-23.77|-74.96|= 0.0016
73871193|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.5277|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5277
73950762|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
73950763|NCT03954158|147435095|OTHER||Difference of least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-1.0|0.5||||||Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.0|
73950764|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.5|0.4||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.4|-1.5|
73950765|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
73950766|NCT03954158|147435095|OTHER||Least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.1|0.3||||||Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.3|-1.1|
73950767|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.4|0.4||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.4|-1.4|
73978362|NCT01604824|147502500|SUPERIORITY||LS Mean Difference|-40.36|STANDARD_ERROR_OF_MEAN|10.471|=|0.0063|TWO_SIDED|95.0|-65.12|15.6||Threshold for significance ≤ 0.05|ANCOVA|||||15.60|-65.12|= 0.0063
73978363|NCT01604824|147502501|SUPERIORITY||LS Mean Difference|-30.75|STANDARD_ERROR_OF_MEAN|7.224|=|0.0017|TWO_SIDED|95.0|-46.85|-14.66||Threshold for significance ≤ 0.05|ANCOVA|||||-14.66|-46.85|= 0.0017
73950768|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.1|0.5||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.1|
73950769|NCT03954158|147435095|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.0|
73950770|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.9|0.5||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-0.9|
73950771|NCT03954158|147435095|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.2|
73950772|NCT03954158|147435095|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.0|
73950773|NCT03954158|147435096|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-0.9|0.7||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-0.9|
73950774|NCT03954158|147435096|OTHER||Least squares mean of difference|0.2|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-0.6|1.0||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.0|-0.6|
73950775|NCT03954158|147435096|OTHER||Difference of least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.8|1.2||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.2|-0.8|
73950776|NCT03954158|147435096|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.9|0.5||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-0.9|
73950777|NCT03954158|147435096|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-1.5|1.0||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.0|-1.5|
73950778|NCT03954158|147435096|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.6|0.5||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.6|
73950779|NCT03954158|147435096|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.1|0.8||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.8|-1.1|
73978364|NCT01604824|147502501|SUPERIORITY||LS Mean Difference|-22.23|STANDARD_ERROR_OF_MEAN|6.294|=|0.0096|TWO_SIDED|95.0|-37.11|-7.34||Threshold for significance ≤ 0.05|ANCOVA|||||-7.34|-37.11|= 0.0096
73950780|NCT03954158|147435096|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.5|1.1||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.1|-1.5|
73950781|NCT03954158|147435096|OTHER||Difference of least squares mean|-0.9|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.4|0.6||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-2.4|
73950782|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.4|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-2.2|-0.5||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.5|-2.2|
73950783|NCT03954158|147435096|OTHER||Least squares mean of difference|0.1|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.3|1.5||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.5|-1.3|
73950784|NCT03954158|147435096|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.7|1.2||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.2|-1.7|
73950785|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.0|
73950786|NCT03954158|147435096|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-1.4|0.5||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-1.4|
73950787|NCT03954158|147435096|OTHER||Difference of least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-1.7|0.8||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-1.7|
73978365|NCT01604824|147502502|SUPERIORITY||LS Mean Difference|-49.72|STANDARD_ERROR_OF_MEAN|9.867|=|0.0005|TWO_SIDED|95.0|-71.71|-27.74||Threshold for significance ≤ 0.05|ANCOVA|||||-27.74|-71.71|= 0.0005
74032595|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.5|||||TWO_SIDED|95.0|1.14|5.52|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 5||5.52|1.14|
74032596|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.24|||||TWO_SIDED|95.0|2.33|11.8|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A||11.80|2.33|
74032597|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|3.77|||||TWO_SIDED|95.0|1.47|9.65|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B||9.65|1.47|
74032598|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.94|||||TWO_SIDED|95.0|1.65|21.36|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F||21.36|1.65|
74089359|NCT02697773|147731616|SUPERIORITY||Odds Ratio (OR)|1.17||||0.4878|TWO_SIDED|95.0|0.75|1.84|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.84|0.75|0.4878
74089360|NCT02697773|147731616|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7856|TWO_SIDED|95.0|0.68|1.67|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.67|0.68|0.7856
74089361|NCT02697773|147731616|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0476|TWO_SIDED|95.0|1.0|2.39|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.39|1.00|0.0476
73950788|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.0|-0.2||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.2|-2.0|
73950789|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-2.1|-0.1||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.1|
73950790|NCT03954158|147435096|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.9|0.6||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.9|
73950791|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.0|
73950792|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.4|-0.2||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.2|-2.4|
73950793|NCT03954158|147435096|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.9|0.7||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.7|-1.9|
73950794|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.3|-0.1||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.3|
73950795|NCT03954158|147435096|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.9|0.1||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.1|-1.9|
73950796|NCT03954158|147435096|OTHER||Difference of least squares mean|-1.1|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.4|0.2||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.2|-2.4|
73950797|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
73950798|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-2.5|-0.7||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.7|-2.5|
73950799|NCT03954158|147435096|OTHER||Difference of least squares mean|-1.4|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.6|-0.2||||||Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.2|-2.6|
73871194|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
73871195|NCT00445770|147286389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
73871196|NCT00445770|147286389|SUPERIORITY_OR_OTHER|||||||0.9371|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.9371
73871197|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0027
73871198|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0015
73871199|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.8875|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8875
73871200|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0015
73871201|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0011
73871202|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.9694|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.9694
73978366|NCT01604824|147502502|SUPERIORITY||LS Mean Difference|-49.33|STANDARD_ERROR_OF_MEAN|11.545|=|0.0037|TWO_SIDED|95.0|-76.63|-22.03||Threshold for significance ≤ 0.05|ANCOVA|||||-22.03|-76.63|= 0.0037
73978367|NCT01638000|147502513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was concluded if the lower limit of the 95% CI for difference of adjusted change from baseline between solifenacin 5 mg and mirabegron 50 mg was \> -0.20. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg. Overall power calculation was 80% for a 1-sided test and significance level of 0.025.|least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.124||0.15|TWO_SIDED|95.0|-0.42|0.06||If p\<0.05, this indicated superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||The non-inferiority of mirabegron vs. solifencacin on the change from baseline to final visit in the mean number of micturitions per 24 hours.||0.06|-0.42|0.15
74032599|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.44|||||TWO_SIDED|95.0|1.17|16.87|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V||16.87|1.17|
73871203|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.0020
73871204|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.0005
73871205|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.7271|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.7271
73871206|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0235|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0235
73871207|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0061
73871208|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.6427|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.6427
73871209|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0036
73871210|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0029
73871211|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.9713|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.9713
73871212|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0060
73871213|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0060
73871214|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.9762|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.9762
73871215|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0554|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0554
73871216|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0181|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0181
73871217|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.6642|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.6642
73871218|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0073
73871219|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0290
73871220|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.5919|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.5919
73978368|NCT01638000|147502514|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||0.03|TWO_SIDED|95.0|1.04|2.25||If P \<0.05, this indicates superiority in favor of the treatment group with the smallest percentage of participants with at least 1 TEAE of dry mouth, constipation or blurred vision during the double-blind period at the final visit.|Regression, Logistic|Included treatment group, sex, age group (\< 65, ≥ 65), number of prior antimuscarinics (1, ≥ 2) and geographic region as factors.||Difference vs Mirabegron. Differences of the percentages were calculated by subtracting the percentage of mirabegron 50 mg group from the percentage of solifenacin 5 mg group.||2.25|1.04|0.030
73978369|NCT01638000|147502515|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.117||0.71|TWO_SIDED|95.0|-0.19|0.27||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.27|-0.19|0.71
73978370|NCT01638000|147502515|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.119||0.053|TWO_SIDED|95.0|-0.47|0.0||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.00|-0.47|0.053
73978371|NCT01638000|147502515|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.125||0.12|TWO_SIDED|95.0|-0.44|0.05||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.05|-0.44|0.12
73978372|NCT01638000|147502516|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.9||||0.33|TWO_SIDED|95.0|0.73|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron.||1.11|0.73|0.33
73978373|NCT01638000|147502516|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.84||||0.21|TWO_SIDED|95.0|0.64|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron.||1.10|0.64|0.21
73978374|NCT01638000|147502516|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.97||||0.83|TWO_SIDED|95.0|0.71|1.32||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron.||1.32|0.71|0.83
73978375|NCT01638000|147502516|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.92||||0.57|TWO_SIDED|95.0|0.68|1.24||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.24|0.68|0.57
73978376|NCT01638000|147502517|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.089||0.36|TWO_SIDED|95.0|-0.25|0.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.10|-0.25|0.36
74032600|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|90.8|||||TWO_SIDED|95.0|16.67|494.56|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 14||494.56|16.67|
74032601|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.83|||||TWO_SIDED|95.0|3.79|83.78|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C||83.78|3.79|
74032602|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.11|||||TWO_SIDED|95.0|3.6|18.3|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A||18.30|3.60|
74089362|NCT02697773|147731616|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0124|TWO_SIDED|95.0|1.12|2.63|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.63|1.12|0.0124
73871221|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0371|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0371
73871222|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0346|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0346
73950800|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
73950801|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-2.2|-0.1||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.2|
73950802|NCT03954158|147435096|OTHER||Difference of least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.2|0.5||||||Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-2.2|
73950803|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.9|0.0||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.9|
73950804|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-2.4|-0.7||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.7|-2.4|
73950805|NCT03954158|147435096|OTHER||Difference of least squares mean|-1.6|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.9|-0.3||||||Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.3|-2.9|
73950806|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-2.5|0.3||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-2.5|
73950807|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-2.4|-0.6||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.6|-2.4|
73978377|NCT01638000|147502517|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.12|TWO_SIDED|95.0|-0.48|0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.03|-0.48|0.12
73950808|NCT03954158|147435096|OTHER||Difference of least squares mean|-1.7|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-3.0|-0.5||||||Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.5|-3.0|
73950809|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-2.5|-0.6||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.6|-2.5|
73950810|NCT03954158|147435096|OTHER||Difference of least squares mean|-1.6|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-2.8|-0.4||||||Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.4|-2.8|
73950811|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-2.5|0.1||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.1|-2.5|
73978378|NCT01638000|147502517|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.163||0.47|TWO_SIDED|95.0|-0.57|0.07||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.07|-0.57|0.47
73950812|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
73950813|NCT03954158|147435096|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.2|-0.3||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.3|-2.2|
73950814|NCT03954158|147435096|OTHER||Difference of least squares mean|-1.4|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.8|-0.1||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.1|-2.8|
73950815|NCT00390455|147435114|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis then is that the hazard ratio of the two treatment arms is 1.0; the alternative hypothesis is that the hazard ratio of the control to the experimental regimen is 1.5 (0.67). The test of these hypotheses is one-sided (alpha = 0.025), and interim analyses will be used to stop for futility and superiority. Under these assumptions, there is at least 90% power to detect the stated difference in median PFS between the two treatment arms.|Hazard Ratio (HR)|1.04||||0.37|TWO_SIDED|95.0|0.82|1.33||Tests were stratified by prior tamoxifen therapy (yes/no) and bone disease only (yes/no).|Log Rank|||||1.33|0.82|0.37
73950816|NCT04076020|147435129|SUPERIORITY|||||||0.99||||||Results presented from Wilcoxon-Mann-Whitney test with PDC as the dependent variable.|Wilcoxon (Mann-Whitney)|||Proportion of days covered (PDC) at 12 months. A sample size of 119 in each study arm enabled us to detect a minimum difference in PDC of 11.7% with 85% power (assuming a standard deviation=30%). Our power calculations assume use of 2-sided tests with 0.05 significance level.||||0.99
73950817|NCT04076020|147435129|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Proportion of days covered (PDC) analyzed as a binary variable with optimal adherence determined as ≥0.80) variables using logistic regression and adjustment for trial stratification factors. Our power calculations assume use of 2-sided tests with 0.05 significance level.||||<0.05
74032603|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|15.29|||||TWO_SIDED|95.0|4.64|50.35|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F||50.35|4.64|
74032604|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.19|||||TWO_SIDED|95.0|1.72|10.25|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F||10.25|1.72|
74032605|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|13.93|||||TWO_SIDED|95.0|9.14|21.23|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1||21.23|9.14|
74032606|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.86|||||TWO_SIDED|95.0|4.17|8.24|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 3||8.24|4.17|
73978379|NCT01638000|147502518|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.92||||0.44|TWO_SIDED|95.0|0.74|1.14||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.14|0.74|0.44
73978380|NCT01638000|147502518|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.79||||0.11|TWO_SIDED|95.0|0.6|1.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 8 Rate Ratio vs. Mirabegron||1.06|0.60|0.11
73978381|NCT01638000|147502518|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.05||||0.78|TWO_SIDED|95.0|0.76|1.45||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron||1.45|0.76|0.78
73978382|NCT01638000|147502518|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.97||||0.85|TWO_SIDED|95.0|0.71|1.33||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Final Visit Rate Ratio vs. Mirabegron||1.33|0.71|0.85
74032607|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|19.97|||||TWO_SIDED|95.0|12.8|31.15|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 4||31.15|12.80|
74032608|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.46|||||TWO_SIDED|95.0|1.87|3.24|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 5||3.24|1.87|
74032609|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|7.12|||||TWO_SIDED|95.0|5.05|10.03|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A||10.03|5.05|
73871223|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.9955|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.9955
73871224|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0187|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0187
74032610|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|7.78|||||TWO_SIDED|95.0|5.54|10.92|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B||10.92|5.54|
74032611|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|10.4|||||TWO_SIDED|95.0|7.4|14.61|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F||14.61|7.40|
74089363|NCT02697773|147731616|SUPERIORITY||Odds Ratio (OR)|1.66||||0.0307|TWO_SIDED|95.0|1.05|2.62|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.62|1.05|0.0307
73950818|NCT04076020|147435130|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Difference in self-reported adherence reported across baseline, 4-, 8-, and 12-month visits using generalized estimating equations and adjusted for trial stratification factors.||||<0.05
73978383|NCT01638000|147502519|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.081||0.66|TWO_SIDED|95.0|-0.18|0.14||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.14|-0.18|0.66
73978384|NCT01638000|147502519|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.17|TWO_SIDED|95.0|-0.31|-0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||-0.03|-0.31|0.17
74089364|NCT02697773|147731616|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0846|TWO_SIDED|95.0|0.95|2.35|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.35|0.95|0.0846
73950819|NCT02500979|147435137|SUPERIORITY_OR_OTHER||Least squares mean difference|-21.5|STANDARD_ERROR_OF_MEAN|7.88||0.0118|TWO_SIDED|95.0|-37.8|-5.2|||Linear mixed-effects model|||||-5.2|-37.8|0.0118
73950820|NCT02500979|147435138|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-7.897||||0.0013|TWO_SIDED|95.0|-12.356|-3.438|||Linear mixed effects model|||||-3.438|-12.356|0.0013
73950821|NCT02500979|147435139|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-5.277||||0.0091|TWO_SIDED|95.0|-9.175|-1.378|||Linear mixed effects model|||||-1.378|-9.175|0.0091
73950822|NCT02500979|147435140|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-4.435||||0.0057|TWO_SIDED|95.0|-7.445|-1.424|||Linear mixed effects model|||||-1.424|-7.445|0.0057
73950823|NCT02500979|147435141|SUPERIORITY_OR_OTHER||Least squares mean difference|-28733.0|STANDARD_ERROR_OF_MEAN|4163.6|<|0.0001|TWO_SIDED|95.0|-37326.0|-20139.0|||Linear mixed-effects model|||||-20139|-37326|<0.0001
73950824|NCT02500979|147435142|SUPERIORITY_OR_OTHER||LS mean difference|-28.418||||0.0258|TWO_SIDED|95.0|-53.099|-3.737|||Linear mixed-effects model|||||-3.737|-53.099|0.0258
73871225|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0645|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0645
73950825|NCT02500979|147435144|SUPERIORITY_OR_OTHER||LS Mean Ratio (Pramlintide/Placebo)|1.31||||0.0456|TWO_SIDED|95.0|1.01|1.7|||Linear mixed-effects model|||||1.70|1.01|0.0456
73950826|NCT02500979|147435145|SUPERIORITY_OR_OTHER||LS mean ratio (pramlintide/placebo)|0.951||||0.1015|TWO_SIDED|95.0|0.896|1.011|||Linear mixed-effects model|||||1.011|0.896|0.1015
73950827|NCT02500979|147435147|SUPERIORITY_OR_OTHER||LS mean ratio (pramlintide/placebo)|1.085||||0.373|TWO_SIDED|95.0|0.901|1.307|||Linear mixed effects model|||||1.307|0.901|0.3730
73950828|NCT00672958|147435156|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74||||0.407|TWO_SIDED|95.0|-2.48|1.01||Pre-specified sequential statistical testing procedure indicates that when p-value for change from baseline in HAMD-24 at Week 6 \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-D24 as a covariate.||Change from Baseline in HAM-D24 total score at Week 6 was tested at significance level 0.05. To control for multiplicity, subsequent endpoints were to be tested in a sequential testing procedure at significance level 0.025; as soon as an endpoint in a sequence was non-significant at 0.025, the testing procedure was stopped for all subsequent endpoints in that sequence.||1.01|-2.48|0.407
73950829|NCT00672958|147435157|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.901|TWO_SIDED|95.0|-0.97|1.1|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Comparison of change from Baseline at Week 1.||1.10|-0.97|0.901
73950830|NCT00672958|147435157|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.701|TWO_SIDED|95.0|-1.07|1.59|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 2||1.59|-1.07|0.701
73871226|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.592|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5920
73950831|NCT00672958|147435157|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.68||||0.356|TWO_SIDED|95.0|-2.11|0.76|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 3||0.76|-2.11|0.356
73950832|NCT00672958|147435157|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33||||0.67|TWO_SIDED|95.0|-1.85|1.19|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 4||1.19|-1.85|0.670
73950833|NCT00672958|147435157|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.87||||0.304|TWO_SIDED|95.0|-2.52|0.79|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 5||0.79|-2.52|0.304
73950834|NCT01380990|147435169|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
73950835|NCT01380990|147435169|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
73950836|NCT01380990|147435169|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
73950837|NCT01380990|147435169|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
73978385|NCT01638000|147502519|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.066||0.66|TWO_SIDED|95.0|-0.24|0.02||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.02|-0.24|0.66
73978386|NCT01638000|147502520|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.43|TWO_SIDED|95.0|-0.44|0.19||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.19|-0.44|0.43
73978387|NCT01638000|147502520|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.157||0.027|TWO_SIDED|95.0|-0.66|-0.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||-0.04|-0.66|0.027
73978388|NCT01638000|147502520|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.164||0.053|TWO_SIDED|95.0|-0.64|0.0|||ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.00|-0.64|0.053
73978389|NCT01638000|147502520|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.163||0.16|TWO_SIDED|95.0|-0.55|0.09||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final Visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.09|-0.55|0.16
74032612|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.07|||||TWO_SIDED|95.0|3.04|5.47|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V||5.47|3.04|
74032613|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|60.32|||||TWO_SIDED|95.0|37.25|97.67|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 14||97.67|37.25|
74032614|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.35|||||TWO_SIDED|95.0|11.37|26.47|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C||26.47|11.37|
74032615|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.11|||||TWO_SIDED|95.0|3.0|5.62|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A||5.62|3.00|
73871227|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.0095|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0095
73950838|NCT01380990|147435169|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
74032616|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.68|||||TWO_SIDED|95.0|6.65|14.08|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F||14.08|6.65|
74032617|NCT05372575|147618270|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.7|||||TWO_SIDED|95.0|6.9|13.64|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F||13.64|6.90|
73871228|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.2112|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.2112
73978390|NCT01638000|147502521|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.023||0.99|TWO_SIDED|95.0|-0.05|0.05||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.05|-0.05|0.99
73978391|NCT01638000|147502521|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.027||0.47|TWO_SIDED|95.0|-0.07|0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.03|-0.07|0.47
73978392|NCT01638000|147502521|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.99|TWO_SIDED|95.0|-0.06|0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.06|-0.06|0.99
73978393|NCT01638000|147502521|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.031||0.74|TWO_SIDED|95.0|-0.05|0.07||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.07|-0.05|0.74
73978394|NCT01638000|147502522|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.03||||0.67|TWO_SIDED|95.0|0.89|1.2||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.20|0.89|0.67
74032618|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.49|||||TWO_SIDED|95.0|0.06|3.91|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1||3.91|0.06|
74032619|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.54|||||TWO_SIDED|95.0|0.1|2.92|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 3||2.92|0.10|
74032620|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.45|||||TWO_SIDED|95.0|0.1|2.07|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 4||2.07|0.10|
74032621|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.78|||||TWO_SIDED|95.0|0.27|11.75|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 5||11.75|0.27|
73871229|NCT00445770|147286390|SUPERIORITY_OR_OTHER|||||||0.1649|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1649
74032622|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.23|||||TWO_SIDED|95.0|0.03|1.65|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A||1.65|0.03|
74032623|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.06|||||TWO_SIDED|95.0|0.01|0.44|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B||0.44|0.01|
74032624|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.21|||||TWO_SIDED|95.0|0.56|2.65|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F||2.65|0.56|
74089365|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.0319|TWO_SIDED|95.0|-0.63|-0.03|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.03|-0.63|0.0319
73871230|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73978395|NCT01638000|147502522|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.17||||0.073|TWO_SIDED|95.0|0.99|1.39||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron||1.39|0.99|0.073
73978396|NCT01638000|147502522|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.12||||0.25|TWO_SIDED|95.0|0.92|1.37||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron||1.37|0.92|0.25
73978397|NCT01638000|147502522|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.08||||0.4|TWO_SIDED|95.0|0.9|1.31||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.31|0.90|0.40
73978398|NCT01638000|147502523|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.115||0.84|TWO_SIDED|95.0|-0.25|0.2||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.20|-0.25|0.84
73978399|NCT01638000|147502523|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.099||0.63|TWO_SIDED|95.0|-0.24|0.15||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.15|-0.24|0.63
73978400|NCT01638000|147502523|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.59|TWO_SIDED|95.0|-0.28|0.16||if p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.16|-0.28|0.59
73978401|NCT01638000|147502524|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.05||||0.068|TWO_SIDED|95.0|1.0|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.11|1.00|0.068
73978402|NCT01638000|147502524|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.04||||0.21|TWO_SIDED|95.0|0.98|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron||1.11|0.98|0.21
73978403|NCT01638000|147502524|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.02||||0.52|TWO_SIDED|95.0|0.95|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron||1.10|0.95|0.52
73978404|NCT01638000|147502524|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.03||||0.44|TWO_SIDED|95.0|0.96|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.10|0.96|0.44
73978405|NCT01638000|147502525|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.047||0.058|TWO_SIDED|95.0|0.0|0.18||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.18|-0.00|0.058
74032625|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.2|||||TWO_SIDED|95.0|0.03|1.26|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V||1.26|0.03|
74032626|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.36|||||TWO_SIDED|95.0|0.08|1.55|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 14||1.55|0.08|
74039483|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.37||0.0003|TWO_SIDED|95.0|-2.06|-0.61|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.61|-2.06|0.0003
73871231|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73950839|NCT01380990|147435169|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
73950840|NCT01380990|147435170|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
73978406|NCT01638000|147502525|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.044||0.5|TWO_SIDED|95.0|-0.06|0.12||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.12|-0.06|0.50
73978407|NCT01638000|147502525|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.046||0.81|TWO_SIDED|95.0|-0.08|0.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.10|-0.08|0.81
73978408|NCT01638000|147502526|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.67|TWO_SIDED|95.0|0.85|1.28||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds ratio vs. Mirabegron||1.28|0.85|0.67
73871232|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.8972|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8972
73871233|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73950841|NCT01380990|147435170|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
73978409|NCT01638000|147502526|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.026|TWO_SIDED|95.0|1.03|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds ratio vs. Mirabegron||1.53|1.03|0.026
73871234|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73871235|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.3736|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.3736
74032627|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.82|||||TWO_SIDED|95.0|0.15|4.47|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C||4.47|0.15|
74032628|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.35|||||TWO_SIDED|95.0|0.19|9.44|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A||9.44|0.19|
74032629|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.87|||||TWO_SIDED|95.0|0.67|22.42|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F||22.42|0.67|
74032630|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.27|||||TWO_SIDED|95.0|0.05|1.52|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F||1.52|0.05|
74032631|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.76|||||TWO_SIDED|95.0|0.19|3.07|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1||3.07|0.19|
74032632|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.02|||||TWO_SIDED|95.0|0.42|2.46|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 3||2.46|0.42|
74032633|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.44|||||TWO_SIDED|95.0|0.05|3.73|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 4||3.73|0.05|
74032634|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.63|||||TWO_SIDED|95.0|0.15|2.73|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 5||2.73|0.15|
74032635|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.88|||||TWO_SIDED|95.0|0.11|6.99|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A||6.99|0.11|
73871236|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73871237|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
74032636|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.9|||||TWO_SIDED|95.0|0.29|12.51|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B||12.51|0.29|
74032637|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.45|||||TWO_SIDED|95.0|0.34|17.43|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F||17.43|0.34|
73871238|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.9324|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.9324
73871239|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
73871240|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
73871241|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.8982|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.8982
73871242|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
73871243|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0007
73871244|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.318|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.3180
73871245|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
73871246|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0011
73871247|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.3302|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.3302
73871248|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
73871249|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0002
73871250|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.6563|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.6563
73871251|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73871252|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73978410|NCT01638000|147502526|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.11|TWO_SIDED|95.0|0.97|1.44||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds ratio vs. Mirabegron||1.44|0.97|0.11
73871253|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.8894|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.8894
73978411|NCT01638000|147502526|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.093|TWO_SIDED|95.0|0.97|1.43||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final Visit Odds ratio vs. Mirabegron||1.43|0.97|0.093
74032638|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.43|||||TWO_SIDED|95.0|0.27|7.7|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V||7.70|0.27|
73871254|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
73871255|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
73871256|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.7826|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.7826
73871257|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
73871258|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0003
73871259|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.5343|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5343
73871260|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
73871261|NCT00445770|147286391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
73871262|NCT00445770|147286391|SUPERIORITY_OR_OTHER|||||||0.9313|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.9313
73871263|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73871264|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73871265|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.8044|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8044
73871266|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73871267|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0003
73871268|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.4652|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.4652
73871269|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73871270|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73950842|NCT01380990|147435170|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
73950843|NCT01380990|147435170|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
73950844|NCT01380990|147435170|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
73871271|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.5612|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.5612
73871272|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0002
73950845|NCT01380990|147435170|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
73950846|NCT01380990|147435175|OTHER|Model includes fixed effects for visit and Baseline, subject as random effect, with compound symmetry covariance structure. Observations with a value of 0 were imputed as 0.01. Model analyses log transformed data, so the adjusted mean refers to the geometric mean ratio between Month 12 and Baseline.|||||=|0.002|||||||Mixed Models Analysis|||"Mixed-Effect Model Repeated Measure (MMRM) Analysis of Change from Baseline to Month 12 in Log-Transformed CD3+ T Cell count (OTL-101\*) for OTL-101\* on-study subjects group."||||= 0.002
73950847|NCT01380990|147435175|OTHER|Model includes fixed effects for visit and Baseline, subject as random effect, with compound symmetry covariance structure. Observations with a value of 0 were imputed as 0.01. Model analyses log transformed data, so the adjusted mean refers to the geometric mean ratio between Month 12 and Baseline.|||||<|0.001|||||||Mixed Models Analysis|||"MMRM Analysis of Change from Baseline to Month 12 in Log-Transformed CD3+ T Cell count (OTL-101\*) for OTL-101\* on-study and CUP subjects group."||||< 0.001
73950848|NCT01380990|147435180|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
73950849|NCT01380990|147435180|SUPERIORITY||Difference in percentages|11.11|||||TWO_SIDED|95.0|-22.41|48.25||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||48.25|-22.41|
73950850|NCT01380990|147435180|SUPERIORITY||Difference in percentages|7.14|||||TWO_SIDED|95.0|-28.1|34.23||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||34.23|-28.10|
73871273|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0002
73871274|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.9749|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.9749
73978412|NCT01638000|147502527|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||0.74|TWO_SIDED|95.0|0.76|1.48||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron||1.48|0.76|0.74
73978413|NCT01638000|147502527|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.74|TWO_SIDED|95.0|0.71|1.63||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron||1.63|0.71|0.74
73978414|NCT01638000|147502527|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.29|TWO_SIDED|95.0|0.81|2.0||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||2.00|0.81|0.29
73871275|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0001
73871276|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0004
73871277|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.729|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.7290
73978415|NCT01638000|147502527|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.29|TWO_SIDED|95.0|0.82|1.9||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.90|0.82|0.29
73978416|NCT01638000|147502528|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.2|TWO_SIDED|95.0|0.9|1.67||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron||1.67|0.90|0.20
73978417|NCT01638000|147502528|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.57|TWO_SIDED|95.0|0.65|1.26||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron||1.26|0.65|0.57
73978418|NCT01638000|147502528|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.92|TWO_SIDED|95.0|0.69|1.39||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.39|0.69|0.92
73871278|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
73978419|NCT01638000|147502528|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.9|TWO_SIDED|95.0|0.73|1.42||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.42|0.73|0.90
73978420|NCT01638000|147502549|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.69|STANDARD_ERROR_OF_MEAN|0.817||0.039|TWO_SIDED|95.0|-3.29|-0.08||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.08|-3.29|0.039
73871279|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0003
73871280|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.5004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.5004
73950851|NCT01380990|147435180|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
74032639|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.3|||||TWO_SIDED|95.0|0.3|17.41|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 14||17.41|0.30|
74032640|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.65|||||TWO_SIDED|95.0|0.14|2.97|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C||2.97|0.14|
74032641|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.51|||||TWO_SIDED|95.0|0.28|8.21|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A||8.21|0.28|
74032642|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.63|||||TWO_SIDED|95.0|0.13|2.97|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F||2.97|0.13|
74032643|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.23|||||TWO_SIDED|95.0|0.15|10.24|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F||10.24|0.15|
74032644|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.15|||||TWO_SIDED|95.0|0.41|23.91|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1||23.91|0.41|
74032645|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|5.02|||||TWO_SIDED|95.0|1.45|17.39|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 3||17.39|1.45|
74032646|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|13.7|||||TWO_SIDED|95.0|1.32|141.81|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 4||141.81|1.32|
74032647|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|48.41|||||TWO_SIDED|95.0|6.16|380.54|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 5||380.54|6.16|
74032648|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.47|||||TWO_SIDED|95.0|0.48|229.1|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A||229.10|0.48|
74032649|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.02|19.83|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B||19.83|0.02|
73871281|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
73871282|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
73871283|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.5727|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.5727
73871284|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73871285|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73871286|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.6713|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.6713
73871287|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
73871288|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0001
73871289|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.7663|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.7663
73950852|NCT01380990|147435180|SUPERIORITY||Difference in percentages|11.11|||||TWO_SIDED|95.0|-10.01|48.25||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||48.25|-10.01|
73950853|NCT01380990|147435180|SUPERIORITY||Difference in percentages|7.14|||||TWO_SIDED|95.0|-12.91|33.87||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||33.87|-12.91|
73950854|NCT01380990|147435181|SUPERIORITY||||||=|0.645|||||||Log Rank|||||||=0.645
73950855|NCT01380990|147435181|SUPERIORITY||||||=|0.299|||||||Log Rank|||||||=0.299
73950856|NCT01380990|147435181|SUPERIORITY||||||=|0.2|||||||Log Rank|||||||= 0.2
73950857|NCT01380990|147435181|SUPERIORITY||||||=|0.028|||||||Log Rank|||||||= 0.028
73950858|NCT01380990|147435181|SUPERIORITY||||||=|0.259|||||||Log Rank|||||||= 0.259
73950859|NCT01380990|147435181|SUPERIORITY||||||=|0.044|||||||Log Rank|||||||= 0.044
73950860|NCT01380990|147435181|SUPERIORITY||Difference in percentages|10.0|||||TWO_SIDED|95.0|-32.05|61.97||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||61.97|-32.05|
73950861|NCT01380990|147435181|SUPERIORITY||Difference in percentages|30.0|||||TWO_SIDED|95.0|-10.72|65.87||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 3-years post treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||65.87|-10.72|
73950862|NCT01380990|147435181|SUPERIORITY||Difference in percentages|23.33|||||TWO_SIDED|95.0|-15.24|54.59||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||54.59|-15.24|
73950863|NCT01380990|147435181|SUPERIORITY||Difference in percentages|15.0|||||TWO_SIDED|95.0|-13.7|63.54||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||63.54|-13.70|
73950864|NCT01380990|147435181|SUPERIORITY||Difference in percentages|35.0|||||TWO_SIDED|95.0|2.29|68.45||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||68.45|2.29|
73950865|NCT01380990|147435181|SUPERIORITY||Difference in percentages|28.33|||||TWO_SIDED|95.0|2.04|56.36||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||56.36|2.04|
73950866|NCT02731313|147435184|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis (H0): kappa coefficient = 0.90||||||0.7436|||||||Kappa-test p-value, 2 sided|||Rationale for the determination of the number of samples:The following hypotheses were considered: two-sided risk alpha = 5%, power (1 - beta) = 90%, a success rate (rate of positive HER-2 status) = 17%, null hypothesis (H0): kappa coefficient = 0.90. 359 samples would allow determining a first estimate of the 0.90 coefficient of correlation kappa. The total number of samples, which had to be included in this study was 395, considering a 10% rate of non-evaluable samples.||||0.7436
73950867|NCT02471404|147435196|NON_INFERIORITY|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% CI of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|0.0294|0.2986|||Mixed Models Analysis|||||0.2986|0.0294|
73950868|NCT02471404|147435196|NON_INFERIORITY|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% Confidence Interval of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|-0.21||||0.001|TWO_SIDED|95.0|-0.3443|-0.0825||(superiority)|Mixed Models Analysis|||||-0.0825|-0.3443|0.001
73950869|NCT02471404|147435197|SUPERIORITY||Risk Difference (RD)|-4.21|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|-6.45|-1.97|||Fisher Exact|||||-1.97|-6.45|<0.001
73950870|NCT02471404|147435197|SUPERIORITY||Risk Difference (RD)|-3.89|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|-6.21|-1.56|||Fisher Exact|||||-1.56|-6.21|<0.001
73950871|NCT02471404|147435198|SUPERIORITY||Mean Difference (Final Values)|-5.3|||<|0.001|TWO_SIDED|95.0|-5.93|-4.67|||Mixed Models Analysis|||||-4.67|-5.93|<0.001
74089366|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.0139|TWO_SIDED|95.0|-0.68|-0.08|||ANCOVA|||Week 1:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.08|-0.68|0.0139
74089367|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.0011|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.25|-1.03|0.0011
73950872|NCT02471404|147435198|SUPERIORITY||Mean Difference (Final Values)|-4.91|||<|0.001|TWO_SIDED|95.0|-5.52|-4.29|||Mixed Models Analysis|||||-4.29|-5.52|<0.001
74032650|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.53|||||TWO_SIDED|95.0|1.98|55.96|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F||55.96|1.98|
74032651|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.32|||||TWO_SIDED|95.0|0.19|56.82|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V||56.82|0.19|
73950873|NCT02471404|147435199|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.374|TWO_SIDED|95.0|-0.43|0.16|||Mixed Models Analysis|||||0.16|-0.43|0.374
73950874|NCT02471404|147435199|SUPERIORITY||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.88|-0.31|||Mixed Models Analysis|||||-0.31|-0.88|<0.001
73950875|NCT02471404|147435200|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.777|TWO_SIDED|95.0|0.67|1.35|||Regression, Cox|||||1.35|0.67|0.777
73950876|NCT02471404|147435200|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.23|0.57|||Regression, Cox|||||0.57|0.23|<0.001
73950877|NCT00614198|147435202|SUPERIORITY_OR_OTHER||||||<|0.01||||||A priori p threshold set for stage 1 (baseline - 8m; p\<0.01) or (baseline - 12 months, p\<0.05) in order to progress to stage 2 (8 or 12 months - 20 or 24 months).|Mixed Models Analysis|||1st stage analysis (baseline-8m or 12m) used a repeated measures model for all assessment measures. Model included baseline, age, time and time\*treatment interaction. Results informed 2nd stage (8 or 12 months - 20 or 24 months). 2nd stage analysis based on various statistical scenarios (baseline vs 12 months on intervention, 12 months of no intervention vs 12 on intervention, baseline vs 24 months on intervention). No ADOS assessments were used at 12 months because of risk of practice effects.||||<0.01
73950878|NCT00065468|147435204|NON_INFERIORITY_OR_EQUIVALENCE|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and Interferon Alfa (IFN)-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.78||||0.0252|TWO_SIDED|95.0|0.63|0.97|||Log Rank|Stratified by prior nephrectomy and region||||0.97|0.63|0.0252
73950879|NCT00065468|147435204|NON_INFERIORITY_OR_EQUIVALENCE|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and IFN-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.93||||0.4902|TWO_SIDED|95.0|0.75|1.15|||Log Rank|Stratified by prior nephrectomy and region||||1.15|0.75|0.4902
73950880|NCT00065468|147435205|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.74||||0.0042|TWO_SIDED|95.0|0.6|0.91|||Log Rank|Stratified by prior nephrectomy and region||||0.91|0.60|0.0042
73950881|NCT00065468|147435205|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76||||0.0107|TWO_SIDED|95.0|0.62|0.94|||Log Rank|Stratified by prior nephrectomy and region||||0.94|0.62|0.0107
73950882|NCT00065468|147435206|SUPERIORITY_OR_OTHER|||||||0.1361|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.1361
73950883|NCT00065468|147435206|SUPERIORITY_OR_OTHER|||||||0.1062|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.1062
73950884|NCT00065468|147435207|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||<0.0001
73950885|NCT00065468|147435207|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.0011
73871290|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
73871291|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0002
73950886|NCT00065468|147435209|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.76|||Log Rank|Stratified by prior nephrectomy and region||||0.76|0.51|<0.0001
73950887|NCT00065468|147435209|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.73||||0.002|TWO_SIDED|95.0|0.6|0.89|||Log Rank|Stratified by prior nephrectomy and region||||0.89|0.60|0.0020
73950888|NCT01225835|147435212|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The significance level is 0.05.|t-test, 2 sided|||||||0.003
73950889|NCT01225835|147435212|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||The significance level is 0.05.|t-test, 2 sided|||Age \< 39 years||||0.015
73950890|NCT01225835|147435212|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||The significance level is 0.05.|t-test, 2 sided|||Age \>= 39 years||||0.027
73950891|NCT01225835|147435214|SUPERIORITY_OR_OTHER|||||||1||95.0||||The significance level is 0.05.|Fisher Exact|||||||1.00
73950892|NCT01225835|147435215|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.004
73950893|NCT01225835|147435216|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||The significance level is 0.05.|t-test, 2 sided|||||||0.121
73950894|NCT01225835|147435217|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Level of significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
73950895|NCT01225835|147435218|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||<0.001
73950896|NCT01225835|147435220|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.482
73950897|NCT01225835|147435221|SUPERIORITY_OR_OTHER|||||||0.871||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Chi-squared|||||||0.871
73950898|NCT01225835|147435222|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||<0.001
73950899|NCT01225835|147435223|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided|||||||0.620
73950900|NCT01225835|147435224|SUPERIORITY_OR_OTHER|||||||0.478||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided|||||||0.478
73950901|NCT01225835|147435225|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact|||||||0.69
73950902|NCT01225835|147435226|SUPERIORITY_OR_OTHER|||||||0.295||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.295
73978421|NCT01638000|147502549|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.849||0.034|TWO_SIDED|95.0|-3.46|-0.13||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.13|-3.46|0.034
73950903|NCT01225835|147435227|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.405
73950904|NCT01225835|147435228|SUPERIORITY_OR_OTHER|||||||1||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact|||||||1.000
73950905|NCT01448044|147435254|SUPERIORITY_OR_OTHER||difference in percentages|38.85|||<|0.0001|TWO_SIDED|95.0|21.703|55.997||The pvalue was based on the CochranMantelHaenszel (CMH) test, stratified by IL28B host genotype, geography, and baseline cirrhosis status.|Cochran-Mantel-Haenszel|||||55.997|21.703|<0.0001
73950906|NCT03912220|147435259|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
73950907|NCT03912220|147435260|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
73950908|NCT03216902|147435265|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
73871292|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.7073|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.7073
73871293|NCT00445770|147286392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
73871294|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0001
73871295|NCT00445770|147286392|SUPERIORITY_OR_OTHER|||||||0.7973|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.7973
73871296|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
73871297|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
74032652|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.0|||||TWO_SIDED|95.0|0.06|63.12|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 14||63.12|0.06|
74032653|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|16.31|||||TWO_SIDED|95.0|2.15|123.48|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C||123.48|2.15|
74032654|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|24.16|||||TWO_SIDED|95.0|1.59|367.81|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A||367.81|1.59|
73950909|NCT03216902|147435265|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
74032655|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|95.06|||||TWO_SIDED|95.0|13.08|691.01|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F||691.01|13.08|
74032656|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.49|||||TWO_SIDED|95.0|0.64|171.84|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F||171.84|0.64|
73950910|NCT03216902|147435265|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
73950911|NCT03216902|147435265|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
73950912|NCT00619476|147435281|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-0.81||||0.013|TWO_SIDED|95.0|-1.4|-0.23||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.23|-1.40|0.013
73950913|NCT00619476|147435281|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-0.7||||0.029|TWO_SIDED|95.0|-1.33|-0.07||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.07|-1.33|0.029
73950914|NCT00619476|147435281|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-1.07||||0.002|TWO_SIDED|95.0|-1.68|-0.45||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.45|-1.68|0.002
73950915|NCT01625910|147435300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.1|0.21||||||Baseline data by group assignment status (intervention or control) using means of the calculated BMI z-scores (U.S. CDC-2000 growth charts) implemented by applying the published LMS (shape, median, and scale) age- and sex/gender-specific parameters. Because of random assignment of a reasonably large number of children, an unadjusted analysis of change in outcomes between intervention and control groups is presented as well as the covariate-adjusted analysis of differences in changes.||0.21|-0.10|
73950916|NCT01625910|147435301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.74|0.4||||||unadjusted net difference between groups||0.40|-0.74|
73950917|NCT02959138|147435302|OTHER|The test-to-reference ratio (geometric least squares mean (GLSM) ratio) and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.68|||||TWO_SIDED|90.0|86.94|143.47||||||The Estimate statement was used to produce the point estimate and the corresponding 90% confidence interval of the difference in PK parameters of interest on a logarithmic scale.||143.47|86.94|
73978422|NCT01638000|147502549|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.917||0.022|TWO_SIDED|95.0|-3.9|-0.3||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.30|-3.90|0.022
73950918|NCT02959138|147435302|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.04|||||TWO_SIDED|90.0|78.47|146.02||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||146.02|78.47|
73978423|NCT01638000|147502549|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.924||0.043|TWO_SIDED|95.0|-3.68|-0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.06|-3.68|0.043
73978424|NCT01638000|147502550|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.14|STANDARD_ERROR_OF_MEAN|0.77||0.14|TWO_SIDED|95.0|-0.37|2.65||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||2.65|-0.37|0.14
73950919|NCT02959138|147435303|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.92|||||TWO_SIDED|90.0|86.92|144.12||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||144.12|86.92|
73950920|NCT02959138|147435303|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.69|||||TWO_SIDED|90.0|79.63|145.65||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||145.65|79.63|
73950921|NCT02959138|147435304|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|102.0|||||TWO_SIDED|90.0|81.42|127.79||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||127.79|81.42|
73950922|NCT02959138|147435304|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|87.8|||||TWO_SIDED|90.0|68.14|113.13||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||113.13|68.14|
73950923|NCT01327547|147435307|SUPERIORITY_OR_OTHER||Difference in proportion|-0.002||||0.4598|TWO_SIDED|95.0|-0.0417|0.0376|||Cochran-Mantel-Haenszel||Difference in proportion: CMH approach weighted by hepatitis B virus (HBV) status and usage of protease inhibitor (PI) regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The Cochran-Mantel-Haenszel (CMH) approach was used. No formal hypothesis test was performed.||0.0376|-0.0417|0.4598
73950924|NCT01327547|147435308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0167|||||TWO_SIDED|95.0|-0.0653|0.0319|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between MVC and placebo for the participants meeting secondary endpoint.|||0.0319|-0.0653|
73950925|NCT01327547|147435308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0177|||||TWO_SIDED|95.0|-0.0805|0.0452|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between maraviroc and placebo for the participants meeting secondary endpoint.|||0.0452|-0.0805|
73950926|NCT01327547|147435313|SUPERIORITY_OR_OTHER||Difference in proportion|-0.015|||||TWO_SIDED|95.0|-0.1484|0.1185|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 48 data presented here.||0.1185|-0.1484|
73950927|NCT01327547|147435313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0255|||||TWO_SIDED|95.0|-0.1784|0.1274|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 96 data presented here.||0.1274|-0.1784|
73950928|NCT01327547|147435313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|||||TWO_SIDED|95.0|-0.2421|0.0761|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 144 data presented here.||0.0761|-0.2421|
73950929|NCT01327547|147435314|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Mean|-41.12||||0.1174|TWO_SIDED|95.0|-92.72|10.49|||ANCOVA||Difference in Least Square (LS) Mean|The above analysis is for CD4+ cells at week 48. Results are from an analysis of covariance (ANCOVA) model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||10.49|-92.72|0.1174
73978425|NCT01638000|147502550|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.55|STANDARD_ERROR_OF_MEAN|0.805||0.055|TWO_SIDED|95.0|-0.03|3.13||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.13|-0.03|0.055
73978426|NCT01638000|147502550|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.55|STANDARD_ERROR_OF_MEAN|0.866||0.074|TWO_SIDED|95.0|-0.15|3.25||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.25|-0.15|0.074
73978427|NCT01638000|147502550|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.41|STANDARD_ERROR_OF_MEAN|0.873||0.11|TWO_SIDED|95.0|-0.3|3.12||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.12|-0.30|0.11
73950930|NCT01327547|147435314|SUPERIORITY_OR_OTHER||Difference in LS Mean|-21.96||||0.593|TWO_SIDED|95.0|-103.05|59.12|||ANCOVA||Difference in LS Mean|The above analysis is for CD8+ cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||59.12|-103.05|0.5930
73950931|NCT01327547|147435314|SUPERIORITY_OR_OTHER||Difference in LS Mean|-48.26||||0.0669|TWO_SIDED|95.0|-99.93|3.41|||ANCOVA|||The above analysis is for CD4+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||3.41|-99.93|0.0669
73950932|NCT01327547|147435314|SUPERIORITY_OR_OTHER||Difference in LS Mean|-65.28||||0.1799|TWO_SIDED|95.0|-161.07|30.5|||ANCOVA|||The above analysis is for CD8+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||30.50|-161.07|0.1799
73950933|NCT01327547|147435314|SUPERIORITY_OR_OTHER||Difference in LS Mean|-27.71||||0.3859|TWO_SIDED|95.0|-90.71|35.29|||ANCOVA|||The above analysis is for CD4+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||35.29|-90.71|0.3859
73950934|NCT01327547|147435314|SUPERIORITY_OR_OTHER||Difference in LS Mean|-31.86||||0.5571|TWO_SIDED|95.0|-138.93|75.21|||ANCOVA|||The above analysis is for CD8+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||75.21|-138.93|0.5571
73950935|NCT01327547|147435315|SUPERIORITY_OR_OTHER||Difference in LS Mean|-56.06||||0.0153|TWO_SIDED|95.0|-101.2|-10.92|||ANCOVA||Difference in LS Mean|The above analysis is for CD38 expression on CD4 and CD8 cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||-10.92|-101.20|0.0153
73950936|NCT01327547|147435315|SUPERIORITY_OR_OTHER||Difference in LS Mean|-44.93||||0.0947|TWO_SIDED|95.0|-97.72|7.87|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||7.87|-97.72|0.0947
73978428|NCT01638000|147502551|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.07|TWO_SIDED|95.0|-0.19|0.01||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.01|-0.19|0.070
73978429|NCT01638000|147502551|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.054||0.003|TWO_SIDED|95.0|-0.27|-0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.06|-0.27|0.003
73950937|NCT01327547|147435315|SUPERIORITY_OR_OTHER||Difference in LS Mean|-29.75||||0.3595|TWO_SIDED|95.0|-93.74|34.24|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||34.24|-93.74|0.3595
73871298|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.1053|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||0.1053
73871299|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
73950938|NCT01327547|147435316|SUPERIORITY_OR_OTHER||Difference in LS Mean|-2.53||||0.4476|TWO_SIDED|95.0|-9.11|4.05|||ANCOVA||Difference in LS Mean|The above analysis is for C-reactive protein cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||4.05|-9.11|0.4476
73950939|NCT01327547|147435316|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.67||||0.3012|TWO_SIDED|95.0|-0.61|1.96|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.96|-0.61|0.3012
73978430|NCT01638000|147502551|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.015|TWO_SIDED|95.0|-0.26|-0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron.Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.03|-0.26|0.015
73978431|NCT01638000|147502551|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.059||0.021|TWO_SIDED|95.0|-0.25|-0.02||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.02|-0.25|0.021
73978432|NCT01638000|147502552|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.141||0.002|TWO_SIDED|95.0|0.15|0.7||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.70|0.15|0.002
73978433|NCT01638000|147502552|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.141||0.003|TWO_SIDED|95.0|0.14|0.7||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.70|0.14|0.003
73978434|NCT01638000|147502553|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean diffrence|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.027|TWO_SIDED|95.0|0.02|0.29||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.29|0.02|0.027
73978435|NCT01638000|147502553|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.071||0.034|TWO_SIDED|95.0|0.01|0.29||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.29|0.01|0.034
73978436|NCT01638000|147502554|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.01|TWO_SIDED|95.0|1.08|1.81||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.81|1.08|0.010
73978437|NCT01638000|147502554|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.011|TWO_SIDED|95.0|1.07|1.75||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.75|1.07|0.011
73871300|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
73871301|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.0144|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.0144
73871302|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
73871303|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
73871304|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.1851|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.1851
73871305|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
73871306|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.0001
73871307|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.2883|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.2883
73871308|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
73871309|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.0007
73871310|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.2221|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.2221
73871311|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
73950940|NCT01327547|147435316|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.92||||0.4196|TWO_SIDED|95.0|-1.33|3.17|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||3.17|-1.33|0.4196
73950941|NCT01327547|147435317|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.3||||0.9904|TWO_SIDED|95.0|-48.66|49.26||Not specifed.|ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||49.26|-48.66|0.9904
73950942|NCT01327547|147435317|SUPERIORITY_OR_OTHER||Difference in LS Mean|10.87||||0.7697|TWO_SIDED|95.0|-62.44|84.18|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||84.18|-62.44|0.7697
73950943|NCT01327547|147435317|SUPERIORITY_OR_OTHER||Difference in LS Mean|-24.49||||0.5816|TWO_SIDED|95.0|-112.21|63.23|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||63.23|-112.21|0.5816
73950944|NCT01327547|147435318|SUPERIORITY_OR_OTHER||Difference in LS Mean|498.04||||0.3786|TWO_SIDED|95.0|-617.33|1613.41|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1613.41|-617.33|0.3786
73950945|NCT01327547|147435318|SUPERIORITY_OR_OTHER||Difference in LS Mean|348.7||||0.4388|TWO_SIDED|95.0|-539.61|1237.01|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1237.01|-539.61|0.4388
73871312|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.0147|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0147
73871313|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.0201|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0201
73871314|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
73871315|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0036
73871316|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.0789|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0789
73871317|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
73871318|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0008
73871319|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.1903|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.1903
73871320|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
73871321|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.0048
73871322|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.1059|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.1059
73871323|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
73871324|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0018
73871325|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.2589|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.2589
73871326|NCT00445770|147286393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
73871327|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.0040
73978438|NCT01638000|147502555|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.037|TWO_SIDED|95.0|1.02|1.62||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.62|1.02|0.037
73978439|NCT01638000|147502555|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.045|TWO_SIDED|95.0|1.01|1.57||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.57|1.01|0.045
73978440|NCT01638000|147502556|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.009|TWO_SIDED|95.0|1.11|2.06||Iif p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥1 point improvement) Odds Rato vs. Mirabegron||2.06|1.11|0.009
73978441|NCT01638000|147502556|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.065|TWO_SIDED|95.0|0.99|1.65||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥2 point improvement) Odds Rato vs. Mirabegron||1.65|0.99|0.065
73978442|NCT01638000|147502556|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.051|TWO_SIDED|95.0|1.0|1.55||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥3 point improvement) Odds Rato vs. Mirabegron||1.55|1.00|0.051
73978443|NCT01638000|147502556|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.14|TWO_SIDED|95.0|0.95|1.47||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥4 point improvement) Odds Rato vs. Mirabegron||1.47|0.95|0.14
73978444|NCT01638000|147502556|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.89|TWO_SIDED|95.0|0.75|1.4||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥5 point improvement) Odds Rato vs. Mirabegron||1.40|0.75|0.89
73978445|NCT01638000|147502556|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.66|TWO_SIDED|95.0|0.64|2.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Week 12 (6 point improvement) Odds Rato vs. Mirabegron||2.04|0.64|0.66
73978446|NCT01638000|147502557|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.016|TWO_SIDED|95.0|1.07|1.93||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥1 point improvement) Odds Rato vs. Mirabegron||1.93|1.07|0.016
73978447|NCT01638000|147502557|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.063|TWO_SIDED|95.0|0.99|1.62||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥2 point improvement) Odds Rato vs. Mirabegron||1.62|0.99|0.063
73978448|NCT01638000|147502557|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.054|TWO_SIDED|95.0|1.0|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥3 point improvement) Odds Rato vs. Mirabegron||1.53|1.00|0.054
73978449|NCT01638000|147502557|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.46||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥4 point improvement) Odds Rato vs. Mirabegron||1.46|0.95|0.15
73978450|NCT01638000|147502557|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.75|TWO_SIDED|95.0|0.77|1.44||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥5 point improvement) Odds Rato vs. Mirabegron||1.44|0.77|0.75
73978451|NCT01638000|147502557|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.66|TWO_SIDED|95.0|0.64|2.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Final visit (6 point improvement) Odds Rato vs. Mirabegron||2.04|0.64|0.66
73871328|NCT00445770|147286393|SUPERIORITY_OR_OTHER|||||||0.2326|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.2326
73950946|NCT01327547|147435318|SUPERIORITY_OR_OTHER||Difference in LS Mean|-173.57||||0.8559|TWO_SIDED|95.0|-2060.81|1713.68|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1713.68|-2060.81|0.8559
73978452|NCT01638000|147502558|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.082|TWO_SIDED|95.0|0.97|1.57||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.57|0.97|0.082
73978453|NCT01638000|147502558|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.15|TWO_SIDED|95.0|0.94|1.49||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.49|0.94|0.15
73871329|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
73950947|NCT01327547|147435319|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.03||||0.8024|TWO_SIDED|95.0|-0.22|0.28|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 48 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.28|-0.22|0.8024
73950948|NCT01327547|147435319|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.15||||0.266|TWO_SIDED|95.0|-0.12|0.43|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 96 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.43|-0.12|0.2660
73950949|NCT01327547|147435319|SUPERIORITY_OR_OTHER||Difference in LS mean|0.15||||0.2855|TWO_SIDED|95.0|-0.12|0.41|||ANCOVA||Difference in LS mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 144 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.41|-0.12|0.2855
73950950|NCT01327547|147435320|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.15||||0.7778|TWO_SIDED|95.0|-0.93|1.23|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.23|-0.93|0.7778
73950951|NCT01327547|147435320|SUPERIORITY_OR_OTHER||Difference in LS mean|0.0||||0.9991|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.10|-0.10|0.9991
73950952|NCT01327547|147435320|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.02||||0.7275|TWO_SIDED|95.0|-0.16|0.11|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.11|-0.16|0.7275
73950953|NCT01327547|147435321|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.07||||0.5201|TWO_SIDED|95.0|-0.15|0.3|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.30|-0.15|0.5201
73950954|NCT01327547|147435321|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.08||||0.4657|TWO_SIDED|95.0|-0.28|0.13|||ANCOVA|||Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.13|-0.28|0.4657
73950955|NCT01327547|147435321|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.03||||0.8087|TWO_SIDED|95.0|-0.25|0.2|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.20|-0.25|0.8087
73950956|NCT01327547|147435322|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.84||||0.1417|TWO_SIDED|95.0|-4.31|0.63|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.63|-4.31|0.1417
73950957|NCT01327547|147435322|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.44||||0.2679|TWO_SIDED|95.0|-4.01|1.14|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.14|-4.01|0.2679
73871330|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
73871331|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.4751|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.4751
73871332|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
73871333|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
73871334|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.4653|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.4653
73871335|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
73871336|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
73978454|NCT01638000|147502559|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.058|TWO_SIDED|95.0|0.99|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.53|0.99|0.058
73978455|NCT01638000|147502559|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.069|TWO_SIDED|95.0|0.99|1.5||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visitI|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.50|0.99|0.069
73978456|NCT02502461|147502560|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.04|TWO_SIDED|95.0|0.1|1.7||Bonferroni correction|t-test, 2 sided|||||1.7|0.1|0.04
73978457|NCT03365622|147502612|SUPERIORITY||Mean Difference (Final Values)|6.306|STANDARD_ERROR_OF_MEAN|7.379||0.3938|TWO_SIDED|95.0|-8.242|20.854|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the total opioid dose administered intraoperatively and postoperatively, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||20.854|-8.242|0.3938
73978458|NCT03365622|147502613|SUPERIORITY||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.283||0.7051|TWO_SIDED|95.0|-0.451|0.666|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.666|-0.451|0.7051
73978459|NCT03365622|147502614|SUPERIORITY||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.317||0.3852|TWO_SIDED|95.0|-0.349|0.901|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.901|-0.349|0.3852
73978460|NCT03365622|147502615|SUPERIORITY||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|2.816||0.8498|TWO_SIDED|95.0|-5.02|6.088|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||6.088|-5.02|0.8498
74089368|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.0053|TWO_SIDED|95.0|-0.93|-0.16|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.16|-0.93|0.0053
74089369|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.21||0.0014|TWO_SIDED|95.0|-1.08|-0.26|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.08|0.0014
73871337|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.7953|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.7953
73871338|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
73871339|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
73871340|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.0848|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0848
73871341|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
73871342|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
73871343|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.6112|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.6112
73871344|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||<0.0001
73978461|NCT03365622|147502616|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|3.007||0.5839|TWO_SIDED|95.0|-7.579|4.28|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||4.28|-7.579|0.5839
73978462|NCT03365622|147502617|SUPERIORITY||Mean Difference (Final Values)|0.399|STANDARD_ERROR_OF_MEAN|0.344||0.2479|TWO_SIDED|95.0|-0.28|1.078|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.078|-0.280|0.2479
73978463|NCT03365622|147502618|SUPERIORITY||Mean Difference (Final Values)|0.484|STANDARD_ERROR_OF_MEAN|0.335||0.1502|TWO_SIDED|95.0|-0.177|1.145|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.145|-0.177|0.1502
73978464|NCT03365622|147502619|SUPERIORITY||Mean Difference (Final Values)|0.339|STANDARD_ERROR_OF_MEAN|0.313||0.2797|TWO_SIDED|95.0|-0.278|0.955|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op surgical pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.955|-0.278|0.2797
73978465|NCT03365622|147502620|SUPERIORITY||Mean Difference (Final Values)|-0.333|STANDARD_ERROR_OF_MEAN|0.739||0.6527|TWO_SIDED|95.0|-1.792|1.125|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to first narcotic use, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.125|-1.792|0.6527
73978466|NCT03365622|147502621|SUPERIORITY||Odds Ratio (OR)|0.465||||0.0499|TWO_SIDED|95.0|0.217|1.0|||Regression, Logistic|Adjusted for age, sex, BMI, type of surgery and TAP block.||A logistic regression model was used to examine the association between treatment assignment and incidence of nausea, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.000|0.217|0.0499
73978467|NCT03365622|147502622|SUPERIORITY||Mean Difference (Final Values)|24.492|STANDARD_ERROR_OF_MEAN|18.165||0.179|TWO_SIDED|95.0|-11.321|60.304|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to discharge from PACU, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||60.304|-11.321|0.179
73978468|NCT03365622|147502623|SUPERIORITY||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.253||0.2811|TWO_SIDED|95.0|-0.226|0.773|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to hospital discharge, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.773|-0.226|0.2811
73978469|NCT02713594|147502648|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.86|||<|0.0001|TWO_SIDED|95.0|-11.28|-4.5|||Abstinence Risk Difference|||||-4.5|-11.28|<.0001
73871345|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0002
73871346|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.3671|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.3671
73871347|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
73950958|NCT01327547|147435322|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.48||||0.1366|TWO_SIDED|95.0|-3.45|0.49|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.49|-3.45|0.1366
73950959|NCT02802020|147435336|SUPERIORITY|||||||0.999|||||||Fisher Exact|||"We hypothesized that pain reduction (as defined in Study endpoints above) would be achieved in a performance goal of at least 53% of patients receiving the study SEMS. Assuming an observed pain reduction rate of 75% and using an exact test with a one-sided alpha of 0.025, 43 patients were required to obtain power of at least 80%."||||0.999
73950960|NCT02802020|147435337|SUPERIORITY|we hypothesized that the proportion of patients reporting one or more related SAE(s) would be below a performance goal of 32%. Assuming an observed SAE rate of 15% and using an exact test with one-sided alpha of 0.025, 57 patients were required to obtain power of at least 80%.||||||0.513|||||||Fisher Exact|||||||0.513
73950961|NCT00506285|147435343|NON_INFERIORITY_OR_EQUIVALENCE|F(1,47)=26.7, p=.001||||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|F(1,47)=26.7, p=.001||||||.001
73950962|NCT00506285|147435344|NON_INFERIORITY_OR_EQUIVALENCE|mixed models analysis||||||0.001|TWO_SIDED|95.0||||F(1,47)=24.8, p=.001|Mixed Models Analysis|||||||.001
73950963|NCT01089556|147435345|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.192||||0.37||95.0|||||Mixed Models Analysis|||||||0.370
73950964|NCT01089556|147435346|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.614|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
73950965|NCT01089556|147435347|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.003||||0.991||95.0|||||Mixed Models Analysis|||||||0.991
73950966|NCT01089556|147435348|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.431|||<|0.001|TWO_SIDED|95.0|1.233|1.662|||Cochran-Mantel-Haenszel|||||1.662|1.233|<0.001
73950967|NCT01089556|147435349|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.052||||0.565|TWO_SIDED|95.0|0.884|1.253|||Cochran-Mantel-Haenszel|||||1.253|0.884|0.565
73950968|NCT01089556|147435350|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.467|||<|0.001|TWO_SIDED|95.0|1.214|1.771|||Cochran-Mantel-Haenszel|||||1.771|1.214|<0.001
73950969|NCT01089556|147435351|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.233||||0.068|TWO_SIDED|95.0|0.98|1.55|||Cochran-Mantel-Haenszel|||||1.550|0.980|0.068
73950970|NCT01089556|147435352|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.279|||<|0.001|TWO_SIDED|95.0|1.125|1.456|||Cochran-Mantel-Haenszel|||||1.456|1.125|<0.001
73950971|NCT01089556|147435353|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.985||||0.843|TWO_SIDED|95.0|0.842|1.151|||Cochran-Mantel-Haenszel|||||1.151|0.842|0.843
73950972|NCT01089556|147435354|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.341|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
73950973|NCT01089556|147435355|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.073||||0.475||95.0|||||Mixed Models Analysis|||||||0.475
73950974|NCT01089556|147435356|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-4.758|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
73950975|NCT01089556|147435357|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.933||||0.289||95.0|||||Mixed Models Analysis|||||||0.289
73950976|NCT01089556|147435358|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.02||||0.071||95.0|||||ANCOVA|||||||0.071
73950977|NCT01089556|147435359|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.193||||0.78||95.0|||||ANCOVA|||||||0.780
73950978|NCT01089556|147435360|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.558||||0.008||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis|||||||0.008
73950979|NCT01089556|147435360|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.423||||0.031||95.0||||p-value is for depression subscale score.|Mixed Models Analysis|||||||0.031
73950980|NCT01089556|147435361|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.615||||0.049||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis|||||||0.049
73950981|NCT01089556|147435361|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.378||||0.198||95.0||||P-value is for depression subscale score.|Mixed Models Analysis|||||||0.198
73950982|NCT01089556|147435366|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.343|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
73950983|NCT01089556|147435367|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.095||||0.385||95.0|||||Mixed Models Analysis|||||||0.385
73950984|NCT01089556|147435368|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-2.02||||0.064||95.0||||P-value is for systolic BP.|ANCOVA|||||||0.064
73950985|NCT01089556|147435368|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|0.135||||0.843||95.0||||P-value is for diastolic BP.|ANCOVA|||||||0.843
73950986|NCT01089556|147435369|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.329||||0.354||95.0||||P-value is for systolic BP.|ANCOVA|||||||0.354
73950987|NCT01089556|147435369|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.003||||0.997||95.0||||P-value is for diastolic BP.|ANCOVA|||||||0.997
73950988|NCT01089556|147435370|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|3.317|||<|0.001||95.0|||||ANCOVA|||||||<0.001
73950989|NCT01089556|147435371|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.942||||0.332||95.0|||||ANCOVA|||||||0.332
73950990|NCT01089556|147435372|SUPERIORITY_OR_OTHER|||||||0.618||95.0|||||Fisher Exact|||||||0.618
73950991|NCT01089556|147435373|SUPERIORITY_OR_OTHER|||||||0.571||95.0|||||Fisher Exact|||||||0.571
73950992|NCT01089556|147435374|SUPERIORITY_OR_OTHER|||||||0.744||95.0|||||Fisher Exact|||||||0.744
73950993|NCT01089556|147435375|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
73950994|NCT02254421|147435403|SUPERIORITY||Treatment difference|-0.02||||0.94|TWO_SIDED|95.0|-0.62|0.57||P-value was calculated from the ANCOVA model including baseline values and stratification factors.|ANCOVA|||||0.57|-0.62|0.94
73950995|NCT02254421|147435404|SUPERIORITY|||||||0.84||||||P-value was calculated from the negative binomial model with stratification factors as covariates.|Negative binomial|||||||0.84
73950996|NCT02254421|147435405|SUPERIORITY|||||||0.98||||||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test stratified by stratification factors.|Cochran-Mantel-Haenszel|||||||0.98
73950997|NCT02254421|147435406|SUPERIORITY|||||||0.19||||||P-value was calculated from the CMH test stratified by stratification factors.|Cochran-Mantel-Haenszel|||||||0.19
73950998|NCT01950273|147435423|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) mean ratio|89.53|||||TWO_SIDED|90.0|75.42|106.29|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||106.29|75.42|
74032657|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|4.86|||||TWO_SIDED|95.0|2.15|10.96|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1||10.96|2.15|
74032658|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|9.57|||||TWO_SIDED|95.0|4.5|20.36|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 3||20.36|4.50|
73871348|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
73871349|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.7618|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.7618
73871350|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
73871351|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
73871352|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.4358|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.4358
73871353|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.0008
73871354|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
73871355|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.6267|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.6267
73871356|NCT00445770|147286394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
73871357|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0004
73871358|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.3564|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.3564
73978470|NCT02713594|147502649|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|Chi-square test value = 196.1, with 5 degrees of freedom.||||||<.0001
73978471|NCT01214200|147502656|OTHER|For the analysis of differences between pre and post treatment a student's t-test was used and was checked with the Wilcoxon signed rank test. A p\<0.05 was considered statistically significant.||||||0.01|||||||Wilcoxon Signed Ranks Test|||||||0.01
73978472|NCT01823224|147502664|SUPERIORITY_OR_OTHER|||||||0.875|TWO_SIDED||||||Repeated analysis of variance|||||||0.875
73978473|NCT01823224|147502665|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Manova|||||||> 0.05
73978474|NCT03737110|147502674|SUPERIORITY||Hazard Ratio (HR)|0.04|||<|0.0001|TWO_SIDED|95.0|0.01|0.18||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at Run-In Baseline.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.18|0.01|<0.0001
73978475|NCT03737110|147502675|SUPERIORITY||Odds Ratio (OR)|12.727||||0.0002|TWO_SIDED|95.0|2.438|66.428||95% confidence interval (CI) and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||66.428|2.438|0.0002
73871359|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.0007
73950999|NCT01950273|147435424|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|94.6||||||90.0|85.04|105.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||105.23|85.04|
73978476|NCT03737110|147502675|SUPERIORITY||Difference in percentages|61.0|||||TWO_SIDED|95.0|36.7|85.2|||||Differences between percentages are reported in percentage points. The 95% confidence intervals for the differences in percentages were based on a normal approximation.|||85.2|36.7|
73951000|NCT01950273|147435425|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|89.94|||||TWO_SIDED|90.0|77.62|104.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||104.23|77.62|
73951001|NCT01950273|147435426|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|97.65|||||TWO_SIDED|90.0|90.45|105.42|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||105.42|90.45|
73951002|NCT01950273|147435427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|249.2|||||TWO_SIDED|90.0|-210.6|709.0|||||Mean difference calculated as BI 695500-Rituximab (MabThera®).|||709|-210.6|
73951003|NCT01950273|147435429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|||||TWO_SIDED|95.0|-29.4|11.1|||||Difference in ORR calculated as ORR (BI695500) - ORR (MabThera®). The confidence interval represented is 95% difference in proportions.|||11.1|-29.4|
73951004|NCT01950273|147435430|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-18.0|22.1|||||Difference in TEAE incidence calculated as BI695500 - TEAE incidence (MabThera®). The confidence interval represented is 95% difference in proportions.|||22.1|-18.0|
73951005|NCT03354637|147435459|SUPERIORITY||Mean Difference (Final Values)|13.88|STANDARD_ERROR_OF_MEAN|4.707||0.038|TWO_SIDED|95.0|0.77|27.0||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.||27.00|0.77|0.038
73951006|NCT03354637|147435459|SUPERIORITY||Mean Difference (Final Values)|9.32|STANDARD_ERROR_OF_MEAN|4.784||0.166|TWO_SIDED|95.0|-3.9|22.55||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.||22.55|-3.90|0.166
73951007|NCT03354637|147435460|SUPERIORITY||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|4.511||0.302|TWO_SIDED|95.0|-5.97|19.17|||Mixed Models Analysis|||||19.17|-5.97|0.302
73951008|NCT03354637|147435460|SUPERIORITY||Mean Difference (Final Values)|3.23|STANDARD_ERROR_OF_MEAN|4.584||0.616|TWO_SIDED|95.0|-9.44|15.9|||Mixed Models Analysis|||||15.90|-9.44|0.616
73951009|NCT03354637|147435461|SUPERIORITY||Mean Difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|2.074||0.125|TWO_SIDED|95.0|-1.26|10.3|||Mixed Models Analysis|||||10.30|-1.26|0.125
73951010|NCT03354637|147435461|SUPERIORITY||Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|2.107||0.234|TWO_SIDED|95.0|-2.3|9.36|||Mixed Models Analysis|||||9.36|-2.30|0.234
73978477|NCT03737110|147502676|SUPERIORITY||Least squares (LS) mean difference|51.2|||<|0.0001|TWO_SIDED|95.0|34.5|68.0||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||68.0|34.5|< 0.0001
73978478|NCT03737110|147502677|SUPERIORITY||Odds Ratio (OR)|10.0||||0.0006|TWO_SIDED|95.0|2.136|46.826||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at RI baseline.|Cochran-Mantel-Haenszel|||||46.826|2.136|0.0006
73978479|NCT03737110|147502677|SUPERIORITY||Difference in percentages|56.0|||||TWO_SIDED|95.0|30.6|81.3|||||Differences between percentages are reported in percentage points. The 95% confidence intervals for the differences in percentages were based on a normal approximation.|||81.3|30.6|
73951011|NCT03354637|147435462|SUPERIORITY||Mean Difference (Final Values)|1.55|STANDARD_ERROR_OF_MEAN|2.131||0.607|TWO_SIDED|95.0|-4.39|7.49|||Mixed Models Analysis|||||7.49|-4.39|0.607
73951012|NCT03354637|147435462|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.165||0.981|TWO_SIDED|95.0|-6.06|5.92|||Mixed Models Analysis|||||5.92|-6.06|0.981
73951013|NCT03354637|147435463|SUPERIORITY||Odds Ratio (OR)|1.4||||0.62|TWO_SIDED|95.0|0.4|4.6|||Mixed Models Analysis|||||4.6|0.4|0.620
73951014|NCT03354637|147435463|SUPERIORITY||Odds Ratio (OR)|1.7||||0.366|TWO_SIDED|95.0|0.5|5.8|||Mixed Models Analysis|||||5.8|0.5|0.366
73951015|NCT03354637|147435464|SUPERIORITY||Odds Ratio (OR)|0.1||||0.157|TWO_SIDED|95.0|0.0|2.3|||Mixed Models Analysis|||||2.3|0.0|0.157
73871360|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.0035
73871361|NCT00445770|147286394|SUPERIORITY_OR_OTHER|||||||0.4749|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.4749
73871362|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
73951016|NCT03354637|147435464|SUPERIORITY||Odds Ratio (OR)|0.4||||0.353|TWO_SIDED|95.0|0.1|2.8|||Mixed Models Analysis|||||2.8|0.1|0.353
73951017|NCT03354637|147435465|SUPERIORITY||Odds Ratio (OR)|1.7||||0.333|TWO_SIDED|95.0|0.6|5.4|||Mixed Models Analysis|||||5.4|0.6|0.333
73951018|NCT03354637|147435465|SUPERIORITY||Odds Ratio (OR)|1.7||||0.388|TWO_SIDED|95.0|0.5|5.2|||Mixed Models Analysis|||||5.2|0.5|0.388
73951019|NCT03354637|147435466|SUPERIORITY||Odds Ratio (OR)|0.7||||0.435|TWO_SIDED|95.0|0.3|1.8|||Mixed Models Analysis|||||1.8|0.3|0.435
73871363|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0001
73871364|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.4376|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.4376
73871365|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
73871366|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
73951020|NCT03354637|147435466|SUPERIORITY||Odds Ratio (OR)|0.6||||0.37|TWO_SIDED|95.0|0.2|1.7|||Mixed Models Analysis|||||1.7|0.2|0.370
73978480|NCT03737110|147502678|SUPERIORITY||Odds Ratio (OR)|8.37||||0.0022|TWO_SIDED|95.0|1.317|53.188||95% CI and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||53.188|1.317|0.0022
73978481|NCT03737110|147502679|SUPERIORITY||Odds Ratio (OR)|10.906|||<|0.0001|TWO_SIDED|95.0|3.051|38.981||95% CI and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||38.981|3.051|< 0.0001
73951021|NCT03354637|147435467|SUPERIORITY||Odds Ratio (OR)|1.7||||0.333|TWO_SIDED|95.0|0.6|5.4|||Mixed Models Analysis|||||5.4|0.6|0.333
73978482|NCT03737110|147502680|SUPERIORITY||LS mean difference|51.9|||<|0.0001|TWO_SIDED|95.0|33.8|70.1||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||70.1|33.8|< 0.0001
73978483|NCT03737110|147502681|SUPERIORITY||LS mean difference|40.5|||<|0.0001|TWO_SIDED|95.0|25.3|55.8||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||55.8|25.3|< 0.0001
73978484|NCT03737110|147502682|SUPERIORITY||Odds Ratio (OR)|30.522||||0.0002|TWO_SIDED|95.0|4.262|218.552||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test adjusted by oral corticosteroid use at RI baseline.|Cochran-Mantel-Haenszel|||||218.552|4.262|0.0002
73978485|NCT03737110|147502683|SUPERIORITY||Odds Ratio (OR)|14.432|||<|0.0001|TWO_SIDED|95.0|3.439|60.574||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at RI baseline.|Cochran-Mantel-Haenszel|||||60.574|3.439|< 0.0001
73978486|NCT03737110|147502684|SUPERIORITY||Difference|75.7|||<|0.0001|TWO_SIDED|95.0|56.8|94.6|||normal approximation|||||94.6|56.8|< 0.0001
73951022|NCT03354637|147435467|SUPERIORITY||Odds Ratio (OR)|1.7||||0.388|TWO_SIDED|95.0|0.5|5.2|||Mixed Models Analysis|||||5.2|0.5|0.388
73951023|NCT03354637|147435468|SUPERIORITY|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||||||0.505
73951024|NCT03354637|147435468|SUPERIORITY|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||||||0.359
73951025|NCT03354637|147435469|SUPERIORITY|||||||0.602|||||||Wilcoxon (Mann-Whitney)|||||||0.602
73978487|NCT03737110|147502685|SUPERIORITY||Hazard Ratio (HR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.05|0.32||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at run-in baseline.|Log Rank||Calculated based on a Cox proportional hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.32|0.05|< 0.0001
73978488|NCT03737110|147502686|SUPERIORITY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.02|0.22||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at run-in baseline.|Log Rank||Calculated based on a Cox proportional hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.22|0.02|< 0.0001
73951026|NCT03354637|147435469|SUPERIORITY|||||||0.643|||||||Wilcoxon (Mann-Whitney)|||||||0.643
73951027|NCT03354637|147435470|SUPERIORITY|||||||0.992|||||||Wilcoxon (Mann-Whitney)|||||||0.992
73951028|NCT03354637|147435470|SUPERIORITY|||||||0.257|||||||Wilcoxon (Mann-Whitney)|||||||0.257
73951029|NCT03354637|147435472|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
73951030|NCT03354637|147435472|SUPERIORITY|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
73951031|NCT03354637|147435474|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||||||0.102
73951032|NCT03354637|147435474|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
73951033|NCT03354637|147435475|SUPERIORITY|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
73951034|NCT03354637|147435475|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
73951035|NCT03230864|147435505|SUPERIORITY||Mean Difference (Final Values)|5.47||||0.0809|TWO_SIDED|95.0|-0.7|11.65|||Mixed Model Repeated Measures|||The mean changes from randomization in PANNS total score was analysed using a mixed model for repeated measures (MMRM) approach. The model will include the fixed, categorical effects of treatment, strata, visit, treatment-by-visit interaction, fixed covariates of baseline scores and baseline scores-by-visit interaction. An unstructured (co)variance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||11.65|-0.70|0.0809
73951036|NCT00432679|147435515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.01|-0.61||Change from Baseline in HbA1c = Treatment+ Baseline HbA1c+ Gender+ body mass index (BMI)|ANCOVA|||||-0.61|-1.01|<0.001
73951037|NCT00432679|147435516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.1|STANDARD_ERROR_OF_MEAN|5.06|<|0.001|TWO_SIDED|95.0|-32.1|-12.1|||Unpaired t-test|||||-12.1|-32.1|<0.001
73951038|NCT00432679|147435517|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.718|STANDARD_ERROR_OF_MEAN|0.8102||0.377|TWO_SIDED|95.0|-0.883|2.319|||Unpaired t-test|||||2.319|-0.883|0.377
73951039|NCT00432679|147435518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|2.094||0.33|TWO_SIDED|95.0|-6.18|2.09|||Unpaired t-test|||||2.09|-6.18|0.330
73951040|NCT00432679|147435519|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.473||0.983|TWO_SIDED|95.0|-0.945|0.925|||Unpaired t-test|||||0.925|-0.945|0.983
73871367|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.3947|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.3947
73978489|NCT03737110|147502687|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.7447|TWO_SIDED|95.0|0.12|4.46||Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and without stratification by randomization strata.|||4.46|0.12|0.7447
73978490|NCT03737110|147502688|SUPERIORITY||Hazard Ratio (HR)|0.36||||0.2066|TWO_SIDED|95.0|0.07|1.87||Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and without stratification by randomization strata.|||1.87|0.07|0.2066
73978491|NCT03737110|147502689|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.0059|TWO_SIDED|95.0|0.0||Not estimable due to low number of participants with an event.|Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||||||0.00|0.0059
73978492|NCT03737110|147502701|SUPERIORITY||Odds Ratio (OR)|0.015|||<|0.0001|TWO_SIDED|95.0|0.002|0.108||Two-sided p value calculated using a Cochran-Mantel-Haenszel test adjudicated by randomization strata.|Cochran-Mantel-Haenszel|||Participants who used ORT, corticosteroids or bailout rilonacept during the RW Period||0.108|0.002|< 0.0001
73871368|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
73871369|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
73871370|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.7378|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.7378
73978493|NCT00047385|147502752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.004|TWO_SIDED|95.0|0.733|0.932||P-value is adjusted for multiple comparisons.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||"Alternative hypothesis: LDCT screening reduces lung cancer mortality relative to chest x-ray.~Power: 90% for a 20% reduction in lung cancer mortality."||0.932|0.733|0.004
73871371|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0001
73871372|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
73871373|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.568|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.5680
73871374|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0003
73871375|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
73871376|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.3978|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.3978
73871377|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||<0.0001
73871378|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0001
73871379|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.7229|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.7229
73871380|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
73871381|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
74032659|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|13.4|||||TWO_SIDED|95.0|5.2|34.51|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 4||34.51|5.20|
73871382|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.7236|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.7236
73871383|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
73871384|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
73978494|NCT00047385|147502753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.02|TWO_SIDED|95.0|0.864|0.988||No adjustment for multiple comparisons. Only one analysis performed.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||Alternative hypothesis: LDCT screening reduced all-cause mortality relative to chest x-ray.||0.988|0.864|0.02
73978495|NCT00047385|147502754|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|1.03|1.23|||||Denominator: LDCT Group Numerator: CXR Group|||1.23|1.03|
73978496|NCT03068312|147502759|OTHER||Least squares mean difference|-0.66|||||TWO_SIDED|95.0|-1.1|-0.21||||||||-0.21|-1.10|
73978497|NCT02551224|147502760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75|||<|0.0001|TWO_SIDED|95.0|0.51|0.99|||Wilcoxon (Mann-Whitney)|||||0.99|0.51|<0.0001
73978498|NCT02551224|147502761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||<|0.0001|TWO_SIDED|95.0|0.21|0.61|||Wilcoxon (Mann-Whitney)|||||0.61|0.21|<0.0001
73978499|NCT00273052|147502762|SUPERIORITY_OR_OTHER||Median Difference (Net)|-8.026||||0.0141||95.0|-15.35|-0.67|||ANCOVA||Median difference = Coreg CR - Toprol XL|||-0.67|-15.35|0.0141
73978500|NCT00273052|147502763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.6068||95.0|-2.4|3.9|||ANCOVA||Mean difference = Coreg CR - Toprol XL|||3.9|-2.4|0.6068
73978501|NCT04803734|147502789|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed Cmax.|Ratio of geometric least square mean|0.862||||0.0328|TWO_SIDED|90.0|0.807|0.922|||ANOVA|||||0.922|0.807|0.0328
73978502|NCT04803734|147502790|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed AUC(0-t).|Ratio of geometric least square mean|0.941|||<|0.0001|TWO_SIDED|90.0|0.909|0.976|||ANOVA|||||0.976|0.909|<0.0001
73978503|NCT04803734|147502791|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed AUC(0-inf).|Ratio of geometric least square mean|0.942|||<|0.0001|TWO_SIDED|90.0|0.91|0.975|||ANOVA|||||0.975|0.910|<0.0001
73978504|NCT01640288|147502796|OTHER|t-test|Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.0349|<|0.0001|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||<0.0001
73871385|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.9719|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.9719
73871386|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
73871387|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
73871388|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.9349|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.9349
73978505|NCT01640288|147502797|OTHER|t-test|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73978506|NCT03883724|147502799|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||||0.3|||||||ANCOVA|between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||Change in NPi pre- vs post-intervention comparing between group analysis||||0.3
73978507|NCT03883724|147502800|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome|||||<|0.01||||||Change in nocturia frequency pre- vs post-intervention comparing between groups BBTI vs IC|ANCOVA|between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||Change in nocturia frequency pre- vs post-intervention comparing between group analysis||||<.01
73978508|NCT03883724|147502801|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||||0.3|||||||ANCOVA|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||0.3
73978509|NCT00195819|147502802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.1||||0.06||95.0|-0.5|40.7|||Chi-squared|||||40.7|-0.5|0.060
73978510|NCT00195819|147502845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.42||0.387||95.0|||||ANCOVA|||||||0.387
73978511|NCT00822900|147502857|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95||||0.35|TWO_SIDED|95.0|0.85|1.06|||Regression, Generalized linear|Adjusting for injury severity, sex, and age. the binomial distribution with the log link is used to estimate treatment effect as relative risk.|A risk ratio (equivalent to the relative risk) of less than 1.00 indicating fewer favorable outcomes in the progesterone group than in the placebo group.|Test of null hypothesis (equal proportions of subjects with favorable outcome in progesterone and placebo arms) versus alternative hypothesis (unequal proportions of subjects with favorable outcome in progesterone and placebo arms). Standard multiple imputation methods are used to account for missing data. The primary outcome measure is based on the stratified dichotomy approach.||1.06|0.85|0.35
73871389|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
73871390|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0002
73871391|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.7226|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.7226
73871392|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
73871393|NCT00445770|147286395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
73871394|NCT00445770|147286395|SUPERIORITY_OR_OTHER|||||||0.5512|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.5512
73871395|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0162|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0162
73871396|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0035
73871397|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.8928|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.8928
73871398|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.0009
73871399|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.0007
73871400|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.6348|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.6348
73978512|NCT00822900|147502858|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.86|1.63|||||A hazard ratio of more than 1.00 indicating higher hazard of death from the progesterone group than in the placebo group.|The Cox proportional hazards model is used to compare these curves after adjustment for age, sex and injury severity.||1.63|0.86|
73978513|NCT00822900|147502860|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.03|||||TWO_SIDED|95.0|1.96|4.66|||||A risk ratio (equivalent to the relative risk) of more than 1.00 indicating more events in the progesterone group than in the placebo group.|||4.66|1.96|
73978514|NCT04660799|147502873|NON_INFERIORITY|The lower limit of the two-sided 90% confidence interval (CI) should be above 0.80 in order to show non-inferiority of Ctrough SC versus Ctrough IV.|Ratio Ctrough SC/Ctrough IV|1.52|||||TWO_SIDED|90.0|1.28|1.79||||||Geometric mean ratio of Ctrough SC/Ctrough IV and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline.||1.79|1.28|
73978515|NCT04660799|147502874|NON_INFERIORITY|The lower limit of the two-sided 90% confidence interval (CI) should be above 0.80 in order to show non-inferiority of AUCsc versus AUCiv.|Geometric mean ratio of AUCsc/AUCiv|1.25|||||TWO_SIDED|90.0|1.1|1.42||||||Geometric mean ratio of AUCsc/AUCiv and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline.||1.42|1.10|
73978516|NCT04660799|147502879|SUPERIORITY||Difference in CRR|18.27|||||TWO_SIDED|95.0|-8.92|45.45||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||45.45|-8.92|
73978517|NCT04660799|147502880|SUPERIORITY||Difference in ORR Investigator|17.63|||||TWO_SIDED|95.0|-6.86|42.11||||||Investigator; Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||42.11|-6.86|
73978518|NCT04660799|147502880|SUPERIORITY||Difference in ORR IRC|14.1|||||TWO_SIDED|95.0|-12.68|40.88||||||IRC; Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||40.88|-12.68|
73978519|NCT04660799|147502881|SUPERIORITY||Difference in CRR|7.05|||||TWO_SIDED|95.0|-22.49|36.59||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||36.59|-22.49|
73978520|NCT04660799|147502882|SUPERIORITY||Difference in CRR|18.59|||||TWO_SIDED|95.0|-9.55|46.73||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||46.73|-9.55|
73978521|NCT01934452|147502888|SUPERIORITY||Hodges Lehmann estimator|2.8|||<|0.001|TWO_SIDED|95.0|2.2|3.8|||Wilcoxon (Mann-Whitney)|||||3.8|2.2|<0.001
73978522|NCT01934452|147502889|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
73978523|NCT01934452|147502890|SUPERIORITY|||||||1|||||||Fisher Exact|||Extended or partial nephrectomy||||1.000
73978524|NCT01934452|147502890|SUPERIORITY|||||||0.809|||||||Chi-squared|||Nephrectomy with or without adrenalectomy||||0.809
73978525|NCT01934452|147502890|SUPERIORITY|||||||0.019|||||||Chi-squared|||Nephrectomy with or without curettage||||0.019
73978526|NCT01934452|147502890|SUPERIORITY|||||||0.734|||||||Fisher Exact|||Open or laparoscopic nephrectomy||||0.734
73978527|NCT01934452|147502891|SUPERIORITY||Hodges Lehmann estimator|-3.7||||0.23|TWO_SIDED|95.0|-13.2|1.6|||Wilcoxon (Mann-Whitney)|||||1.6|-13.2|0.230
73978528|NCT01934452|147502892|SUPERIORITY|||||||0.695|||||||Fisher Exact|||Sarcomatoid contingent||||0.695
73978529|NCT01934452|147502893|SUPERIORITY|||||||0.316|||||||Chi-squared|||M class||||0.316
73978530|NCT01934452|147502894|SUPERIORITY||Hodges Lehmann estimator|-2.0||||0.778|TWO_SIDED|95.0|-22.0|18.0|||Wilcoxon (Mann-Whitney)|||||18.0|-22.0|0.778
73978531|NCT01934452|147502895|SUPERIORITY|||||||0.812|||||||Fisher Exact|||||||0.812
73978532|NCT01934452|147502896|SUPERIORITY||Odds Ratio (OR)|2.47||||0.077|TWO_SIDED|95.0|0.9|6.77|||Chi-squared|||Presence of necrosis||6.77|0.90|0.077
73978533|NCT01934452|147502896|SUPERIORITY||Odds Ratio (OR)|1.25||||0.673|TWO_SIDED|95.0|0.44|3.52|||Chi-squared|||Vascular embolism||3.52|0.44|0.673
73978534|NCT01934452|147502896|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.27|3.97|||Fisher Exact|||Sarcomatoid component||3.97|0.27|1.000
73978535|NCT01934452|147502897|SUPERIORITY||Hodges Lehmann estimator|-0.2||||0.865|TWO_SIDED|95.0|-1.5|1.6|||Wilcoxon (Mann-Whitney)|||||1.6|-1.5|0.865
73978536|NCT01934452|147502898|SUPERIORITY|||||||0.011|||||||Chi-squared|||Lung||||0.011
73978537|NCT01934452|147502898|SUPERIORITY|||||||0.132|||||||Chi-squared|||Bones||||0.132
73978538|NCT01934452|147502898|SUPERIORITY|||||||0.473|||||||Chi-squared|||Liver||||0.473
73978539|NCT01934452|147502898|SUPERIORITY|||||||0.101|||||||Fisher Exact|||Adrenal glands||||0.101
73871401|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0026|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.0026
73871402|NCT00445770|147286396|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
73978540|NCT01934452|147502898|SUPERIORITY|||||||0.445|||||||Fisher Exact|||Pancreas||||0.445
73978541|NCT01934452|147502898|SUPERIORITY|||||||0.04|||||||Chi-squared|||Lymph nodes||||0.040
73978542|NCT01934452|147502899|SUPERIORITY|||||||1|||||||Fisher Exact|||Supradiaphragmatic||||1.000
73978543|NCT01934452|147502899|SUPERIORITY|||||||0.295|||||||Fisher Exact|||Infradiaphragmatic||||0.295
74032660|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|17.15|||||TWO_SIDED|95.0|7.76|37.91|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 5||37.91|7.76|
74032661|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|40.2|||||TWO_SIDED|95.0|15.16|106.65|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A||106.65|15.16|
74032662|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|20.38|||||TWO_SIDED|95.0|8.39|49.51|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B||49.51|8.39|
74032663|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|21.22|||||TWO_SIDED|95.0|8.65|52.07|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F||52.07|8.65|
74032664|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|23.73|||||TWO_SIDED|95.0|10.39|54.19|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V||54.19|10.39|
74032665|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.84|||||TWO_SIDED|95.0|5.46|30.22|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 14||30.22|5.46|
73871403|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.4629|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.4629
73871404|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0841|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0841
73871405|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0007
73871406|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.1957|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.1957
73871407|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0093|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0093
73978544|NCT01934452|147502900|SUPERIORITY|||||||0.042|||||||Fisher Exact|||||||0.042
73978545|NCT01934452|147502901|SUPERIORITY|||||||0.027|||||||Chi-squared|||||||0.027
73978546|NCT01934452|147502902|SUPERIORITY||Hodges Lehmann estimator|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|-1.0|||Wilcoxon (Mann-Whitney)|||||-1.0|-1.0|<0.001
73978547|NCT01934452|147502903|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
73978548|NCT00849485|147502949|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|98.0||||||90.0|94.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.5|
73978549|NCT00849485|147502950|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|99.9||||||90.0|97.6|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|97.6|
73978550|NCT00849485|147502951|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|98.1|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|98.1|
73978551|NCT00186446|147502952|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|t(19)= -8.93||||||<.001
74032666|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.88|||||TWO_SIDED|95.0|5.95|27.88|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C||27.88|5.95|
73871408|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0326|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0326
73978552|NCT02833948|147502992|SUPERIORITY|||||||0.01|||||||Fisher Exact|The Fisher's exact probability test was used to compare the percentages of patients with the primary end point between the treatment groups.||||||0.01
73978553|NCT02833948|147502996|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
73978554|NCT02397707|147503002|OTHER||Geometric Least-Square Mean (GLSM)Ratio%|411.62|||||TWO_SIDED|90.0|214.72|789.08||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.||789.08|214.72|
73978555|NCT02397707|147503002|OTHER||GLSM Ratio (%)|644.15|||||TWO_SIDED|90.0|364.67|1137.82||||||An ANOVA appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||1137.82|364.67|
73978556|NCT02397707|147503003|OTHER||GLSM Ratio (%)|399.24|||||TWO_SIDED|90.0|210.89|755.81||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||755.81|210.89|
73978557|NCT02397707|147503003|OTHER||GLSM Ratio (%)|599.63|||||TWO_SIDED|90.0|342.36|1050.22||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.||1050.22|342.36|
73978558|NCT02397707|147503004|OTHER||GLSM Ratio (%)|338.41|||||TWO_SIDED|90.0|168.96|677.79||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||677.79|168.96|
73978559|NCT02397707|147503004|OTHER||GLSM Ratio (%)|713.92|||||TWO_SIDED|90.0|384.07|1327.06||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||1327.06|384.07|
73978560|NCT04821271|147503005|OTHER|Treatment comparison||||||0.91|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.91
73978561|NCT04821271|147503006|OTHER|Treatment comparison||||||0.47|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.47
73978562|NCT04821271|147503007|OTHER|Treatment comparison||||||0.14|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.14
73978563|NCT04821271|147503008|OTHER|Treatment comparison||||||0.12|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.12
73871409|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.7426|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.7426
73871410|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0013
73978564|NCT04821271|147503009|OTHER|Treatment comparison||||||0.69|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.69
73978565|NCT04821271|147503010|OTHER|Treatment comparison||||||0.73|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.73
73978566|NCT04821271|147503011|OTHER|Treatment comparison||||||0.28|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.28
73978567|NCT04076059|147503025|SUPERIORITY||Cox Proportional Hazard|0.13|||<|0.0001|TWO_SIDED|95.0|0.076|0.222|||Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|||0.222|0.076|<0.0001
73978568|NCT04076059|147503026|SUPERIORITY||Cox Proportional Hazard|0.33|||<|0.0001|TWO_SIDED|95.0|0.196|0.556|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||0.556|0.196|<0.0001
73978569|NCT04076059|147503027|SUPERIORITY||Cox Proportional Hazard|0.789||||0.7279|TWO_SIDED|95.0|0.208|2.998|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||2.998|0.208|0.7279
73978570|NCT04076059|147503028|SUPERIORITY||Cox Proportional Hazard|0.172|||<|0.0001|TWO_SIDED|95.0|0.107|0.276|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||0.276|0.107|<0.0001
74089370|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.17|-0.36|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.36|-1.17|0.0002
74089371|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.33|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.49|-1.33|<.0001
74089372|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.36|-0.52|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.52|-1.36|<.0001
74089373|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.23||0.0015|TWO_SIDED|95.0|-1.16|-0.28|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.28|-1.16|0.0015
74089374|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.22||0.0023|TWO_SIDED|95.0|-1.12|-0.24|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.24|-1.12|0.0023
74089375|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.23||0.0512|TWO_SIDED|95.0|-0.89|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||0.00|-0.89|0.0512
74089376|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.22||0.0693|TWO_SIDED|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||0.03|-0.85|0.0693
74089377|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.24||0.0043|TWO_SIDED|95.0|-1.14|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.21|-1.14|0.0043
73871411|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0015
73978571|NCT04076059|147503029|SUPERIORITY|||||||0.0036|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||||0.0036
73978572|NCT04076059|147503030|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||||<0.0001
73978573|NCT04076059|147503031|SUPERIORITY||Cox Proportional Hazard|0.797||||0.5899|TWO_SIDED|95.0|0.35|1.819|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||1.819|0.350|0.5899
73978574|NCT04076059|147503032|SUPERIORITY||Difference in Percentage|53.5|||<|0.0001|TWO_SIDED|95.0|40.1|66.9|||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||66.9|40.1|<0.0001
73978575|NCT04076059|147503033|SUPERIORITY||Difference in Percentage|-5.2||||0.8312|TWO_SIDED|95.0|-25.4|14.9|||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||14.9|-25.4|0.8312
73978576|NCT05640167|147503037|OTHER|||||||0.015|||||||t-test, 2 sided|Degrees of freedom 17||||||0.015
73871412|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.6552|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.6552
73871413|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.0005
73871414|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.0004
73871415|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.6294|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.6294
73871416|NCT00445770|147286396|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
73871417|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.0001
73871418|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.4652|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.4652
73978577|NCT05640167|147503038|OTHER|||||||0.114||||||Positive p = 0.114 Health-directed p = 0.028 Skill and Technique p = 0.013 Constructive attitudes p = 0.003 Self-monitoring \& insight p = 0.001 Health service navigation p = 0.077 Social Integration p = 0.126 Emotional well-being p = 0.093|t-test, 2 sided|||||||0.114
73978578|NCT05640167|147503039|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
73871419|NCT00445770|147286396|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
73871420|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.0002
73978579|NCT05640167|147503040|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
73978580|NCT05640167|147503041|OTHER|||||||0.309|||||||t-test, 2 sided|||||||0.309
73978581|NCT05640167|147503042|OTHER|||||||0.827|||||||t-test, 2 sided|||||||0.827
73871421|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.2233|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.2233
73871422|NCT00445770|147286396|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
73871423|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0003
73871424|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.6772|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.6772
73871425|NCT00445770|147286396|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
73871426|NCT00445770|147286396|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
73871427|NCT00445770|147286396|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.6160
73871428|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
73871429|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
73871430|NCT00445770|147286397|SUPERIORITY_OR_OTHER|||||||0.4929|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||0.4929
73871431|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
73871432|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
73871433|NCT00445770|147286397|SUPERIORITY_OR_OTHER|||||||0.9693|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.9693
73871434|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
73871435|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
73871436|NCT00445770|147286397|SUPERIORITY_OR_OTHER|||||||0.4139|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.4139
73871437|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
73871438|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
73871439|NCT00445770|147286397|SUPERIORITY_OR_OTHER|||||||0.8905|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.8905
73871440|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
73871441|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
73978582|NCT00768716|147503067|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
73978583|NCT00768716|147503068|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
73978584|NCT00768716|147503069|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
73978585|NCT00768716|147503071|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
73978586|NCT00768716|147503072|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
73978587|NCT00768716|147503073|OTHER|||||||0.003|||||||ANOVA|||||||0.003
73871442|NCT00445770|147286397|SUPERIORITY_OR_OTHER|||||||0.6877|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.6877
73871443|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
73871444|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
74089378|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.0041|TWO_SIDED|95.0|-1.13|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.21|-1.13|0.0041
73871445|NCT00445770|147286397|SUPERIORITY_OR_OTHER|||||||0.4511|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.4511
74089379|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0024|TWO_SIDED|95.0|-1.19|-0.26|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.19|0.0024
74089380|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.24||0.0015|TWO_SIDED|95.0|-1.22|-0.29|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.29|-1.22|0.0015
74089381|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.25||0.0063|TWO_SIDED|95.0|-1.16|-0.19|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.19|-1.16|0.0063
74089382|NCT02697773|147731617|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.24||0.0008|TWO_SIDED|95.0|-1.3|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.34|-1.30|0.0008
73871446|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
73871447|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
73871448|NCT00445770|147286397|SUPERIORITY_OR_OTHER|||||||0.2786|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.2786
73871449|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
73871450|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
73871451|NCT00445770|147286397|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.1230
73978588|NCT00799409|147503079|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-35.0|-22.3||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA|||-22.3|-35.0|<0.0001
73871452|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
73871453|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
73871454|NCT00445770|147286397|SUPERIORITY_OR_OTHER|||||||0.5061|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.5061
73871455|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
73871456|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
73871457|NCT00445770|147286397|SUPERIORITY_OR_OTHER|||||||0.1354|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.1354
73871458|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
73871459|NCT00445770|147286397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
73871460|NCT00445770|147286397|SUPERIORITY_OR_OTHER|||||||0.1734|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.1734
74089383|NCT02697773|147731619|SUPERIORITY||Least Square Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.61|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.61|-1.47|<.0001
73978589|NCT00799409|147503080|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.3|||<|0.0001|TWO_SIDED|95.0|-34.4|-22.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA|||-22.2|-34.4|<0.0001
73978590|NCT00799409|147503081|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|||<|0.0001|TWO_SIDED|95.0|4.3|7.4||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||7.4|4.3|<0.0001
73978591|NCT00799409|147503082|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1|||<|0.0001|TWO_SIDED|95.0|3.8|6.5||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||6.5|3.8|<0.0001
73978592|NCT00799409|147503083|SUPERIORITY_OR_OTHER||LS Mean Difference|11.0|||<|0.0001|TWO_SIDED|95.0|8.7|13.3||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||13.3|8.7|<0.0001
73978593|NCT00799409|147503084|SUPERIORITY_OR_OTHER||LS Means Difference|-3.16|||<|0.0001|TWO_SIDED|95.0|-3.72|-2.59||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.59|-3.72|<0.0001
73978594|NCT00799409|147503085|SUPERIORITY_OR_OTHER||LS Means Difference|-16.03|||<|0.0001|TWO_SIDED|95.0|-19.99|-12.06||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-12.06|-19.99|<0.0001
73978595|NCT00799409|147503086|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.45|||<|0.0001|TWO_SIDED|95.0|-27.43|-17.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-17.47|-27.43|<0.0001
73978596|NCT00799409|147503087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.93||||0.18|TWO_SIDED|95.0|-1.69|-0.16||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.16|-1.69|0.1800
73978597|NCT00799409|147503088|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.32||||0.0057|TWO_SIDED|95.0|-2.25|-0.4||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.40|-2.25|0.0057
73978598|NCT00799409|147503089|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.1091|TWO_SIDED|95.0|-14.05|1.44||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||1.44|-14.05|0.1091
73978599|NCT00799409|147503090|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.2653|TWO_SIDED|95.0|-0.7|0.2||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.20|-0.70|0.2653
73978600|NCT00799409|147503091|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.49||||0.0038|TWO_SIDED|95.0|-10.81|-2.17||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.17|-10.81|0.0038
73978601|NCT00799409|147503092|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.75||||0.0001|TWO_SIDED|95.0|-6.96|-2.53||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.53|-6.96|0.0001
73978602|NCT00799409|147503093|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.76||||0.0092|TWO_SIDED|95.0|-10.04|-1.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-1.47|-10.04|0.0092
73978603|NCT00799409|147503094|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.9195|TWO_SIDED|95.0|-0.37|0.33||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.33|-0.37|0.9195
73978604|NCT00799409|147503095|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.55||||0.0002|TWO_SIDED|95.0|-59.7|-19.39||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-19.39|-59.70|0.0002
73978605|NCT00799409|147503096|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.0002|TWO_SIDED|95.0|-0.13|-0.04||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.04|-0.13|0.0002
73978606|NCT00799409|147503097|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.4625|TWO_SIDED|95.0|-0.07|0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.03|-0.07|0.4625
73978607|NCT00799409|147503098|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.6262|TWO_SIDED|95.0|-0.09|0.05||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.05|-0.09|0.6262
73978608|NCT00799409|147503099|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.998|TWO_SIDED|95.0|-0.08|0.08||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.08|-0.08|0.9980
73978609|NCT00799409|147503100|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.0151|TWO_SIDED|95.0|-0.19|-0.02||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.02|-0.19|0.0151
73978610|NCT00799409|147503101|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.0043|TWO_SIDED|95.0|-0.15|-0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.03|-0.15|0.0043
73978611|NCT00799409|147503102|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.0371|TWO_SIDED|95.0|-0.08|0.0||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.00|-0.08|0.0371
73978612|NCT00799409|147503103|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.0965|TWO_SIDED|95.0|-0.06|0.01||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.01|-0.06|0.0965
73871461|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73871462|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
73871463|NCT00445770|147286398|SUPERIORITY_OR_OTHER|||||||0.6417|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.6417
73871464|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73871465|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
73871466|NCT00445770|147286398|SUPERIORITY_OR_OTHER|||||||0.4698|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.4698
73951041|NCT00432679|147435520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.22|STANDARD_ERROR_OF_MEAN|3.556||0.022|TWO_SIDED|95.0|1.191|15.248|||Unpaired t-test|||||15.248|1.191|0.022
73951042|NCT00432679|147435521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.21|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|6.52|9.91|||Unpaired t-test|||||9.91|6.52|<0.001
74009148|NCT04666350|147569057|OTHER||Combined Difference in Prevalence|-0.025||||0.711|TWO_SIDED|95.0|-0.16|0.109|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.109|-0.160|0.711
74032667|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|26.99|||||TWO_SIDED|95.0|11.46|63.58|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A||63.58|11.46|
73871467|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73871468|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
73871469|NCT00445770|147286398|SUPERIORITY_OR_OTHER|||||||0.1214|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.1214
73871470|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
73871471|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
73871472|NCT00445770|147286398|SUPERIORITY_OR_OTHER|||||||0.4654|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.4654
73871473|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
73871474|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
73871475|NCT00445770|147286398|SUPERIORITY_OR_OTHER|||||||0.4006|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.4006
73871476|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
73871477|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
73871478|NCT00445770|147286398|SUPERIORITY_OR_OTHER|||||||0.1636|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.1636
73871479|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
73871480|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
73871481|NCT00445770|147286398|SUPERIORITY_OR_OTHER|||||||0.2635|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2635
73871482|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73951043|NCT00432679|147435522|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.355||0.069|TWO_SIDED|95.0|-0.05|1.35|||Unpaired t-test||Comparison of leptin.|||1.35|-0.05|0.069
73951044|NCT00432679|147435522|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-888.8|STANDARD_ERROR_OF_MEAN|803.96||0.271|TWO_SIDED|95.0|-2477.7|700.1|||Unpaired t-test||Comparison of hs-CRP|||700.1|-2477.7|0.271
73951045|NCT00432679|147435523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.6|||||TWO_SIDED|95.0|27.1|54.1|||||Comparison of HbA1c, decrease by 0.7%|||54.1|27.1|
73951046|NCT00432679|147435523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8|||||TWO_SIDED|95.0|-0.3|13.8|||||Comparison of HbA1c, fell below 6.5%|||13.8|-0.3|
73951047|NCT00432679|147435523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.6|||||TWO_SIDED|95.0|27.1|54.1|||||Comparison of HbA1c, satisfied either 1 or 2|||54.1|27.1|
73871483|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
73871484|NCT00445770|147286398|SUPERIORITY_OR_OTHER|||||||0.0965|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0965
73871485|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
73978613|NCT03964974|147503104|SUPERIORITY|2-sided hypothesis tests were utilized to compare ISI score over time in the two treatment conditions.|Median Difference (Final Values)|-4.307|STANDARD_ERROR_OF_MEAN|1.612||0.0041|TWO_SIDED|95.0|-7.51|-1.104||This is the calculated p-value. The threshold for statistical significance was 0.05.|Mixed Models Analysis|||Persons in the CBTI-CB condition were hypothesized as realizing greater reduction in insomnia severity as measured by the Insomnia Severity Index (ISI) over time compared to the Sleep Hygiene Education (SHE) condition. 80% power was estimated to detect a medium or larger effect size (d\>0.52) on sleep- and functioning-related outcomes, even with a more conservative alpha set at 0.017 (i.e., 0.05/3 for the 3 outcomes).|Parameter is estimated difference in final means, CBTi-CB - Control. Minus sign denotes greater decrease for CBTi-CB. Effect size for Time X Condition = 0.81|-1.104|-7.510|0.0041
73978614|NCT02660086|147503117|SUPERIORITY||Mean Difference (Net)|0.2||||0.7|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||||1.0|-0.6|0.70
73978615|NCT02660086|147503118|SUPERIORITY||Mean Difference (Net)|0.6||||0.2|TWO_SIDED|95.0|-0.3|1.4|||Mixed Models Analysis|||||1.4|-0.3|0.20
73978616|NCT02660086|147503119|SUPERIORITY||Mean Difference (Net)|-1.3||||0.24|TWO_SIDED|95.0|-3.6|0.9|||Mixed Models Analysis|||Change in systolic BP at 12 months||0.9|-3.6|0.24
73978617|NCT02660086|147503119|SUPERIORITY||Mean Difference (Net)|1.5||||0.19|TWO_SIDED|95.0|-0.7|3.7|||Mixed Models Analysis|||Change in systolic BP at 24 months||3.7|-0.7|0.19
73871486|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
73871487|NCT00445770|147286398|SUPERIORITY_OR_OTHER|||||||0.4437|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.4437
73871488|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
73871489|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
73871490|NCT00445770|147286398|SUPERIORITY_OR_OTHER|||||||0.1663|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.1663
73871491|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
73871492|NCT00445770|147286398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
73871493|NCT00445770|147286398|SUPERIORITY_OR_OTHER|||||||0.1049|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1049
73978618|NCT02660086|147503119|SUPERIORITY||Mean Difference (Net)|-1.6||||0.07|TWO_SIDED|95.0|-3.2|0.1|||Mixed Models Analysis|||Change in diastolic BP at 12 months||0.1|-3.2|0.07
74089384|NCT02697773|147731619|SUPERIORITY||Least Mean Square Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.62|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.62|-1.47|<.0001
74089385|NCT02697773|147731619|SUPERIORITY||Least Square Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.67|-0.81|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.81|-1.67|<.0001
74089386|NCT02697773|147731619|SUPERIORITY||Least Square Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.66|-0.8|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.80|-1.66|<.0001
74089387|NCT02697773|147731619|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.23||0.0007|TWO_SIDED|95.0|-1.25|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-1.25|0.0007
74089388|NCT02697773|147731619|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.23||0.0013|TWO_SIDED|95.0|-1.2|-0.29|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-1.20|0.0013
74089389|NCT02697773|147731619|SUPERIORITY||Least Square Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.51|-0.55|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.55|-1.51|<.0001
74089390|NCT02697773|147731619|SUPERIORITY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.67|-0.73|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.73|-1.67|<.0001
74089391|NCT02697773|147731619|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.25||0.0007|TWO_SIDED|95.0|-1.32|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.32|0.0007
74089392|NCT02697773|147731619|SUPERIORITY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.48|-0.51|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.48|<.0001
74089393|NCT02697773|147731621|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.22|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.22|<.0001
73978619|NCT02660086|147503119|SUPERIORITY||Mean Difference (Net)|0.1||||0.94|TWO_SIDED|95.0|-1.5|1.6|||Mixed Models Analysis|||Change in diastolic BP at 24 months||1.6|-1.5|0.94
73871494|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||<0.0001
73871495|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||<0.0001
73871496|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.0442|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||0.0442
73978620|NCT02660086|147503120|SUPERIORITY||Mean Difference (Net)|-1.3||||0.54|TWO_SIDED|95.0|-5.6|2.9|||Mixed Models Analysis|||Change in total cholesterol at 12 months||2.9|-5.6|0.54
73978621|NCT02660086|147503120|SUPERIORITY||Mean Difference (Net)|1.6||||0.53|TWO_SIDED|95.0|-3.5|6.7|||Mixed Models Analysis|||Change in total cholesterol at 24 months||6.7|-3.5|0.53
73871497|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
73871498|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
73978622|NCT02660086|147503121|SUPERIORITY||Mean Difference (Net)|-1.2||||0.51|TWO_SIDED|95.0|-4.8|2.4|||Mixed Models Analysis|||Change in LDL at 12 months||2.4|-4.8|0.51
73978623|NCT02660086|147503121|SUPERIORITY||Mean Difference (Net)|1.2||||0.6|TWO_SIDED|95.0|-3.4|5.7|||Mixed Models Analysis|||Change in LDL at 24 months||5.7|-3.4|0.60
73978624|NCT02660086|147503122|SUPERIORITY||Mean Difference (Net)|-2.9||||0.48|TWO_SIDED|95.0|-10.8|5.1|||Mixed Models Analysis|||Change in triglycerides at 12 months||5.1|-10.8|0.48
73978625|NCT02660086|147503122|SUPERIORITY||Mean Difference (Net)|4.0||||0.29|TWO_SIDED|95.0|-3.4|11.5|||Mixed Models Analysis|||Change in triglycerides at 24 months||11.5|-3.4|0.29
73978626|NCT02660086|147503123|SUPERIORITY||Mean Difference (Net)|-0.2||||0.8|TWO_SIDED|95.0|-1.9|1.5|||Mixed Models Analysis|||Change in HDL at 12 months||1.5|-1.9|0.80
73978627|NCT02660086|147503123|SUPERIORITY||Mean Difference (Net)|-0.3||||0.72|TWO_SIDED|95.0|-1.9|1.3|||Mixed Models Analysis|||Change in HDL at 24 months||1.3|-1.9|0.72
73978628|NCT02660086|147503124|SUPERIORITY||Mean Difference (Net)|0.0||||0.62|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||Change in hemoglobin A1C at 12 months||0.1|-0.1|0.62
73978629|NCT02660086|147503124|SUPERIORITY||Mean Difference (Net)|0.0||||0.4|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||Change in hemoglobin A1C at 24 months||0.1|0.0|0.40
73978630|NCT02660086|147503125|SUPERIORITY||Mean Difference (Net)|7.3|||<|0.001|TWO_SIDED|95.0|5.4|9.3|||Mixed Models Analysis|||Change in green labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 months||9.3|5.4|<0.001
73978631|NCT02660086|147503125|SUPERIORITY||Mean Difference (Net)|4.8|||<|0.001|TWO_SIDED|95.0|2.9|6.8|||Mixed Models Analysis|||Change in green-labeled purhases during 12 month follow-up (months 13-24) compared to 12 month baseline||6.8|2.9|<0.001
73978632|NCT02660086|147503126|SUPERIORITY||Mean Difference (Net)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.0|-2.7|||Mixed Models Analysis|||Change in red labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 months||-2.7|-5.0|<0.001
73978633|NCT02660086|147503126|SUPERIORITY||Mean Difference (Net)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.3|-2.0|||Mixed Models Analysis|||Change in red labeled purchases during 12-month follow up (months 13-24) compared to baseline 12 months||-2.0|-4.3|<0.001
73978634|NCT02660086|147503127|SUPERIORITY||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|4.2|7.0|||Mixed Models Analysis|||Change in healthy purchasing score during 12 month intervention (months 1-12) compared to baseline 12 months||7.0|4.2|<0.001
73978635|NCT02660086|147503127|SUPERIORITY||Mean Difference (Net)|4.0|||<|0.001|TWO_SIDED|95.0|2.6|5.3|||Mixed Models Analysis|||Change in Healthy Purchasing Score during 12 month follow up (months 13-24) compared to baseline 12 months||5.3|2.6|<0.001
74032668|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|15.53|||||TWO_SIDED|95.0|7.02|34.38|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F||34.38|7.02|
73871499|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.0681|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.0681
73871500|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
73871501|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
73978636|NCT02660086|147503128|SUPERIORITY||Mean Difference (Net)|1.8|||||TWO_SIDED|95.0|-0.6|4.1||||||Change in HEI scores at 12 months.||4.1|-0.6|
73978637|NCT02660086|147503128|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-0.7|3.8||||||Change in HEI scores at 24 months||3.8|-0.7|
73978638|NCT01653509|147503129|SUPERIORITY_OR_OTHER||Least square mean difference|-911.48||||0.3061|TWO_SIDED|95.0|-2712.65|889.69|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.||889.69|-2712.65|0.3061
73978639|NCT01653509|147503129|SUPERIORITY_OR_OTHER||LS Mean Difference|-150.99||||0.4035|TWO_SIDED|95.0|-517.97|215.99|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between treatments for MEV.||215.99|-517.97|0.4035
74032669|NCT05372575|147618271|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|48.73|||||TWO_SIDED|95.0|18.67|127.16|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F||127.16|18.67|
73871502|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.0966|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.0966
73871503|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
73951048|NCT00432679|147435523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|9.5|36.6|||||Comparison of FPG, decrease of 30 milligrams per decilliter|||36.6|9.5|
73951049|NCT00432679|147435523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.9|||||TWO_SIDED|95.0|-5.1|18.9|||||Comparison of FPG, fell below 126 milligrams per deciliter|||18.9|-5.1|
73951050|NCT00432679|147435523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.5|||||TWO_SIDED|95.0|5.6|35.3|||||Comparison of FPG, satisfied either 1 or 2|||35.3|5.6|
73951051|NCT01744496|147435530|SUPERIORITY_OR_OTHER||Least Square Mean|-0.76|STANDARD_ERROR_OF_MEAN|0.55||0.172|TWO_SIDED|95.0|-1.87|0.34|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.34|-1.87|0.172
73951052|NCT01744496|147435532|SUPERIORITY_OR_OTHER||Least Square Mean|-8.01|STANDARD_ERROR_OF_MEAN|3.77||0.038|TWO_SIDED|95.0|-15.56|-0.46|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||-0.46|-15.56|0.038
73978640|NCT01653509|147503130|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48||||0.0486|TWO_SIDED|95.0|0.02|4.93|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV (Day 1 to day 10).||4.93|0.02|0.0486
73951053|NCT01744496|147435533|SUPERIORITY_OR_OTHER||Least Square Mean|-1.02|STANDARD_ERROR_OF_MEAN|0.87||0.247|TWO_SIDED|95.0|-2.76|0.73|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.73|-2.76|0.247
73951054|NCT01744496|147435534|SUPERIORITY_OR_OTHER||Least Square Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.64||0.371|TWO_SIDED|95.0|-1.85|0.7|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.70|-1.85|0.371
73951055|NCT01744496|147435535|SUPERIORITY_OR_OTHER||Least Square Mean|-2.82|STANDARD_ERROR_OF_MEAN|2.97||0.346|TWO_SIDED|95.0|-8.76|3.13|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||3.13|-8.76|0.346
73951056|NCT00600743|147435537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|128.2|STANDARD_ERROR_OF_MEAN|41.4||0.007|TWO_SIDED|95.0||||t test following ANOVA for difference between drug and placebo - There were 3 doses, and the value reported is for the highest and only effective dose|t-test, 2 sided|The overall error term was used to compare differences between placebo and drug||Repeated measures ANOVA||||0.007
73951057|NCT00600743|147435538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.4|STANDARD_ERROR_OF_MEAN|22.8||0.033|TWO_SIDED|95.0||||t-test after ANOVA with repeated measures on placebo minus drug (within groups) between binge and normal instructions (between groups)|t-test, 2 sided|This was part of an overall ANOVA (SAS proc mixed) with all four groups (3 doses eat normally. 4 ng dose, binge eat) and the error term had 76 df.||Each group was compared separately in an overall ANOVA with all dose groups included. The results are presented for the groups which received 4 mg dose and instructions to eat normally (normal group) or to binge eat (binge group). The test is the interaction between drug and group i.e. drug effect difference (placebo minus drug) in fullness between the group instructed to binge and the group instructed to eat normally.||||.033
73871504|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.0006
73871505|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.1242|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.1242
73871506|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
73871507|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.001
73951058|NCT00600743|147435539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.4286|STANDARD_ERROR_OF_MEAN|13.134|<|0.014|TWO_SIDED|||||p-value is based on ANOVA with all groups and conditions and is a planned comparison|ANOVA||df = 53. 26 Used proc GLMMIX in SAS 9.4.|Tests the difference between drug and placebo for group = binge instructions||||<.014
73951059|NCT00579982|147435546|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Paired t-test|t-test, 2 sided|||||||<0.001
73951060|NCT04827134|147435562|OTHER||Ratio of Geometric Least Square Means|0.88|||||TWO_SIDED|90.0|0.8344|0.9282|||||An analysis of variance (ANOVA) was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9282|0.8344|
73951061|NCT04827134|147435562|OTHER||Ratio of Geometric Least Square Means|0.8578|||||TWO_SIDED|90.0|0.8168|0.9007|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9007|0.8168|
73871508|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.1521|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.1521
73951062|NCT04827134|147435562|OTHER||Ratio of Geometric Least Square Means|0.8919|||||TWO_SIDED|90.0|0.8316|0.9566|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9566|0.8316|
73871509|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
73871510|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0070
73871511|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0140
73871512|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
73871513|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
73871514|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.0815|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0815
73871515|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
73871516|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0002
73871517|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.0886|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0886
73871518|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
73871519|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.0003
73951063|NCT04827134|147435563|OTHER||Ratio of Geometric Least Square Means|0.8744|||||TWO_SIDED|90.0|0.8293|0.9219|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9219|0.8293|
73951064|NCT04827134|147435563|OTHER||Ratio of Geometric Least Square Means|0.8567|||||TWO_SIDED|90.0|0.8159|0.8995|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.8995|0.8159|
73951065|NCT04827134|147435563|OTHER||Ratio of Geometric Least Square Means|0.8798|||||TWO_SIDED|90.0|0.8202|0.9438|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9438|0.8202|
73951066|NCT04827134|147435564|OTHER||Ratio of Geometric Least Square Means|0.7102|||||TWO_SIDED|90.0|0.6598|0.7643|||||An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.7643|0.6598|
73951067|NCT04827134|147435564|OTHER||Ratio of Geometric Least Square Means|0.4503|||||TWO_SIDED|90.0|0.3976|0.51|||||An analysis of variance was performed on parameter Cmax for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.5100|0.3976|
73951068|NCT04827134|147435564|OTHER||Ratio of Geometric Least Square Means|0.6373|||||TWO_SIDED|90.0|0.5594|0.726|||||An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.7260|0.5594|
73951069|NCT04827134|147435565|OTHER||Ratio of Geometric Least Square Means|0.9148|||||TWO_SIDED|90.0|0.8834|0.9472|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9472|0.8834|
73978641|NCT01653509|147503130|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.0799|TWO_SIDED|95.0|-0.05|0.82|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.||0.82|-0.05|0.0799
73978642|NCT01653509|147503131|SUPERIORITY_OR_OTHER||LS mean difference|2.14||||0.179|TWO_SIDED|95.0|-1.06|5.35|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.||5.35|-1.06|0.1790
73978643|NCT01653509|147503131|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.2446|TWO_SIDED|95.0|-0.27|1.0|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.||1.00|-0.27|0.2446
73978644|NCT01711294|147503139|SUPERIORITY|Sample sizes were calculated using two-sample t-test for the primary endpoint and z-test for the secondary endpoint with power of 80% and two-sided alpha of 0.05. Hochberg step up procedure was used to adjust for multiple comparison. A p-value \< 0.05 was considered statistically significant.||||||0.84||||||Hochberg step up procedure was used to adjust for multiple comparison.|Wilcoxon (Mann-Whitney)|Wilcoxon was used instead of t-test because the data was not normally distributed.||Study hypothesizes that aspiration % in the 19G Flex and 19G arms would be superior by at least 10% to 22G arm, and aspiration success rate of 19G Flex would be at least 16% greater than 22G and 19G arms. Sample size calculation was performed based on the above hypotheses reached by a consensus of all collaborators and adjusted a priori.||||0.84
73978645|NCT02605174|147503155|SUPERIORITY||Odds Ratio (OR)|1.5||||0.003|TWO_SIDED|95.0|1.1|1.9|||Regression, Logistic|||||1.9|1.1|0.003
73978646|NCT02605174|147503155|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
73978647|NCT02605174|147503155|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
73978648|NCT02605174|147503156|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.1|1.8|||Regression, Logistic|||||1.8|1.1|0.009
73978649|NCT02605174|147503156|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0|||Regression, Logistic|||||2.0|1.2|<0.001
73978650|NCT02605174|147503156|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.4|2.4|||Regression, Logistic|||||2.4|1.4|<0.001
73978651|NCT02605174|147503157|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
73978652|NCT02605174|147503157|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.7|2.9|||Regression, Logistic|||||2.9|1.7|<0.001
73978653|NCT02605174|147503157|SUPERIORITY||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
73978654|NCT02605174|147503159|SUPERIORITY||Odds Ratio (OR)|0.7||||0.002|TWO_SIDED|95.0|0.5|0.9|||Regression, Logistic|||||0.9|0.5|0.002
73978655|NCT02605174|147503159|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.7|||Regression, Logistic|||||0.7|0.4|<0.001
73978656|NCT02605174|147503159|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Regression, Logistic|||||0.4|0.3|<0.001
73978657|NCT02605174|147503160|SUPERIORITY||Odds Ratio (OR)|1.0||||0.917|TWO_SIDED|95.0|0.7|1.5|||Regression, Logistic|||||1.5|0.7|0.917
73978658|NCT02605174|147503160|SUPERIORITY||Odds Ratio (OR)|0.7||||0.129|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||||1.1|0.5|0.129
73978659|NCT02605174|147503160|SUPERIORITY||Odds Ratio (OR)|0.8||||0.456|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|||||1.3|0.6|0.456
73978660|NCT02605174|147503162|SUPERIORITY||Odds Ratio (OR)|0.9||||0.522|TWO_SIDED|95.0|0.7|1.2|||Regression, Logistic|||||1.2|0.7|0.522
73978661|NCT02605174|147503162|SUPERIORITY||Odds Ratio (OR)|1.1||||0.622|TWO_SIDED|95.0|0.8|1.4|||Regression, Logistic|||||1.4|0.8|0.622
73978662|NCT02605174|147503162|SUPERIORITY||Odds Ratio (OR)|1.0||||0.992|TWO_SIDED|95.0|0.8|1.3|||Regression, Logistic|||||1.3|0.8|0.992
73978663|NCT02605174|147503163|SUPERIORITY||Odds Ratio (OR)|1.4||||0.008|TWO_SIDED|95.0|1.1|1.7|||Regression, Logistic|||||1.7|1.1|0.008
73978664|NCT02605174|147503163|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.0|||Regression, Logistic|||||2.0|1.3|<0.001
73978665|NCT02605174|147503163|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
73978666|NCT02605174|147503164|SUPERIORITY||Odds Ratio (OR)|1.4||||0.007|TWO_SIDED|95.0|1.1|1.7|||Regression, Logistic|||||1.7|1.1|0.007
73978667|NCT02605174|147503164|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
73978668|NCT02605174|147503164|SUPERIORITY||Odds Ratio (OR)|1.8|||<|0.001|TWO_SIDED|95.0|1.4|2.3|||Regression, Logistic|||||2.3|1.4|<0.001
73978669|NCT03960645|147503190|OTHER||GLSM ratio (%)|41.24|||||TWO_SIDED|90.0|36.71|46.32||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio (%).||46.32|36.71|
73978670|NCT03960645|147503190|OTHER||GLSM ratio (%)|44.65|||||TWO_SIDED|90.0|40.04|49.79||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||49.79|40.04|
73978671|NCT03960645|147503190|OTHER||GLSM ratio (%)|40.57|||||TWO_SIDED|90.0|36.77|44.76||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||44.76|36.77|
73978672|NCT03960645|147503190|OTHER||GLSM ratio (%)|44.4|||||TWO_SIDED|90.0|39.95|49.34||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||49.34|39.95|
73978673|NCT03960645|147503191|OTHER||GLSM ratio (%)|67.38|||||TWO_SIDED|90.0|63.45|71.56||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||71.56|63.45|
73978674|NCT03960645|147503191|OTHER||GLSM ratio (%)|64.26|||||TWO_SIDED|90.0|60.95|67.75||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||67.75|60.95|
73978675|NCT03960645|147503191|OTHER||GLSM ratio (%)|69.19|||||TWO_SIDED|90.0|65.88|72.66||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||72.66|65.88|
74032670|NCT01954121|147618316|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for the adjusted difference in seizure free proportion in the LEV minus the seizure free proportion in the CBZ-IR group was set to absolute -20% points.|adjusted difference in proportions|-22.9|||||TWO_SIDED|95.0|-33.1|-12.6||||||The adjusted absolute difference in treatment group seizure-free proportions (referenced as 'Adjusted difference in proportions' in 'Method of Estimation' below) was derived from the adjusted treatment group proportions of seizure-free subjects. The adjusted proportions were derived from a logistic regression model of seizure freedom using treatment and the categories for the number of seizures in the 3-month period prior to Visit 1 (≤2 seizures and \>2 seizures) as covariates.||-12.6|-33.1|
74032671|NCT01355068|147618349|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|101.33|||||TWO_SIDED|90.0|97.85|104.94||||||Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||104.94|97.85|
74032672|NCT01355068|147618350|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|102.2|||||TWO_SIDED|90.0|97.18|107.47||||||Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.47|97.18|
74032673|NCT01355068|147618351|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|101.43|||||TWO_SIDED|90.0|97.56|105.47||||||Natural log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||105.47|97.56|
74032674|NCT00576693|147618368|SUPERIORITY_OR_OTHER|||||||0.0252|||||||Log Rank|||The statistical analysis was based on a comparison of the of the two treatment groups with respect to the time to a primary outcome using the logrank test.||||0.0252
74032675|NCT00804193|147618369|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% CI was contained within the interval -0.20 to +0.20 (-20% to +20%).|Difference in Percentage of Participants|9.0|||||TWO_SIDED|90.0|-0.69|18.85|||Wald's method, Yates|CI calculated using Wald's method with Yates' continuity correction.|The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||18.85|-0.69|
74032676|NCT00804193|147618370|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|1.0||||0.001|TWO_SIDED|90.0|-7.08|9.24|||Wald's method with Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||9.24|-7.08|0.001
74032677|NCT00804193|147618371|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|4.0||||0.001|TWO_SIDED|90.0|-4.6|14.24|||Wald's method Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||14.24|-4.60|0.001
74032678|NCT01721408|147618393|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the 2 treatments were equally effective, with cure rates of 75 % at the TOC assessment, the study was powered to ensure with 90% probability that the lower limit of a 2-sided 95% confidence interval (CI) for the true difference (tigecycline minus imipenem/cilastatin) in cure rates was greater than -15%.|Difference in percentage|-6.7||||0.0008|TWO_SIDED|95.0|-12.0|-1.4|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.|||-1.4|-12.0|0.0008
74032679|NCT01721408|147618394|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|TWO_SIDED|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in cure rate were calculated by the asymptotic method corrected for continuity with normal distribution approximation.|||0.5|-15.2|0.0277
74032680|NCT01721408|147618395|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in eradication rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|TWO_SIDED|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in eradication rates were calculated by the asymptotic method corrected for continuity with normal distribution approximation.|||0.5|-15.2|0.0277
74032681|NCT01721408|147618397|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-6.0||||0.004|TWO_SIDED|95.0|-12.8|0.8|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.|||0.8|-12.8|0.0040
73951070|NCT04827134|147435565|OTHER||Ratio of Geometric Least Square Means|0.8847|||||TWO_SIDED|90.0|0.8303|0.9426|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9426|0.8303|
73951071|NCT04827134|147435566|OTHER||Ratio of Geometric Least Square Means|0.9163|||||TWO_SIDED|90.0|0.8862|0.9475|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9475|0.8862|
73951072|NCT04827134|147435566|OTHER||Ratio of Geometric Least Square Means|0.8806|||||TWO_SIDED|90.0|0.8251|0.9398|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9398|0.8251|
73978676|NCT03960645|147503191|OTHER||GLSM ratio (%)|65.09|||||TWO_SIDED|90.0|61.79|68.57||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.57|61.79|
73978677|NCT03960645|147503191|OTHER||GLSM ratio (%)|77.62|||||TWO_SIDED|90.0|65.4|92.14||||||TAF: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||92.14|65.40|
73871520|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.1488|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.1488
73951073|NCT04827134|147435567|OTHER||Ratio of Geometric Least Square Means|0.7284|||||TWO_SIDED|90.0|0.6576|0.8068|||||An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.8068|0.6576|
73978678|NCT03960645|147503191|OTHER||GLSM ratio (%)|62.5|||||TWO_SIDED|90.0|50.76|76.96||||||TAF: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||76.96|50.76|
73978679|NCT03960645|147503191|OTHER||GLSM ratio (%)|69.67|||||TWO_SIDED|90.0|58.57|82.88||||||TAF: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||82.88|58.57|
73978680|NCT03960645|147503191|OTHER||GLSM ratio (%)|56.52|||||TWO_SIDED|90.0|46.32|68.96||||||TAF: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.96|46.32|
73978681|NCT03960645|147503193|OTHER||GLSM ratio (%)|51.91|||||TWO_SIDED|90.0|46.48|57.97||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||57.97|46.48|
73978682|NCT03960645|147503193|OTHER||GLSM ratio (%)|57.67|||||TWO_SIDED|90.0|52.48|63.36||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||63.36|52.48|
73978683|NCT03960645|147503193|OTHER||GLSM ratio (%)|48.18|||||TWO_SIDED|90.0|43.03|53.94||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||53.94|43.03|
73978684|NCT03960645|147503193|OTHER||GLSM ratio (%)|54.42|||||TWO_SIDED|90.0|48.39|61.21||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||61.21|48.39|
73978685|NCT03960645|147503193|OTHER||GLSM ratio (%)|75.61|||||TWO_SIDED|90.0|66.7|85.7||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.70|66.70|
73978686|NCT03960645|147503193|OTHER||GLSM ratio (%)|77.81|||||TWO_SIDED|90.0|68.76|88.05||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||88.05|68.76|
73978687|NCT03960645|147503193|OTHER||GLSM ratio (%)|77.45|||||TWO_SIDED|90.0|70.33|85.29||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.29|70.33|
73978688|NCT03960645|147503193|OTHER||GLSM ratio (%)|77.08|||||TWO_SIDED|90.0|69.78|85.15||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.15|69.78|
73978689|NCT03960645|147503193|OTHER||GLSM ratio (%)|69.9|||||TWO_SIDED|90.0|56.16|87.0||||||TAF: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||87.00|56.16|
73978690|NCT03960645|147503193|OTHER||GLSM ratio (%)|66.55|||||TWO_SIDED|90.0|53.79|82.34||||||TAF: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||82.34|53.79|
73871521|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
73978691|NCT03960645|147503193|OTHER||GLSM ratio (%)|57.14|||||TWO_SIDED|90.0|46.04|70.91||||||TAF: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||70.91|46.04|
73978692|NCT03960645|147503193|OTHER||GLSM ratio (%)|55.27|||||TWO_SIDED|90.0|44.65|68.42||||||TAF: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.42|44.65|
73871522|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0006
73871523|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.0979|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0979
73951074|NCT04827134|147435567|OTHER||Ratio of Geometric Least Square Means|0.5191|||||TWO_SIDED|90.0|0.4535|0.5943|||||An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.5943|0.4535|
73951075|NCT00507026|147435633|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73951076|NCT00507026|147435633|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73951077|NCT00507026|147435634|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73951078|NCT00507026|147435634|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73951079|NCT00507026|147435635|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73951080|NCT00507026|147435635|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73951081|NCT00507026|147435636|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73951082|NCT00507026|147435636|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73951083|NCT00507026|147435637|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73951084|NCT00507026|147435637|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73951085|NCT01952301|147435653|NON_INFERIORITY_OR_EQUIVALENCE|The primary hypothesis of the study evaluated whether CM was not inferior to Control in the generation of KT width from baseline to 6 months. A paired t-test was used to test for non-inferiority, using a one-sided significance level of 0.05 and a non-inferiority margin of 1.0 mm.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73951086|NCT01994720|147435661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.067|TWO_SIDED|95.0|0.78|1.01||In order to address the issue of multiple testing, a hierarchical test sequence will be used. Tested at 4.98% level.|Regression, Cox|||Composite of stroke/MI/death||1.01|0.78|0.0670
73951087|NCT01994720|147435662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0462|TWO_SIDED|95.0|0.76|1.0||If the treatment effect on the primary efficacy variable is significant at the 4.98% level, the secondary efficacy variable will be tested in a confirmatory sense. Otherwise it will be tested in an exploratory manner.|Regression, Cox|||Ischemic stroke||1.00|0.76|0.0462
73978693|NCT03960645|147503194|OTHER||GLSM ratio (%)|26.17|||||TWO_SIDED|90.0|21.45|31.93||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||31.93|21.45|
73978694|NCT03960645|147503194|OTHER||GLSM ratio (%)|26.99|||||TWO_SIDED|90.0|22.23|32.78||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||32.78|22.23|
73978695|NCT03960645|147503194|OTHER||GLSM ratio (%)|29.03|||||TWO_SIDED|90.0|25.74|32.74||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||32.74|25.74|
73978696|NCT03960645|147503194|OTHER||GLSM ratio (%)|29.97|||||TWO_SIDED|90.0|26.47|33.93||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||33.93|26.47|
74032682|NCT05319535|147618405|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.26|TWO_SIDED|95.0|-1.8|6.1|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||6.1|-1.8|0.26
74032683|NCT05319535|147618406|SUPERIORITY||rate ratio|1.7||||0.11|TWO_SIDED|95.0|0.9|3.4|||negative binomial regression|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||3.4|0.9|0.11
74032684|NCT05319535|147618407|SUPERIORITY||Mean Difference (Final Values)|37.6||||0.17|TWO_SIDED|95.0|-18.1|93.3|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||93.3|-18.1|0.17
74032685|NCT05319535|147618408|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1|TWO_SIDED|95.0|-0.1|1.4|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||1.4|-0.1|0.10
74032686|NCT05319535|147618409|SUPERIORITY||rate ratio|1.3||||0.36|TWO_SIDED|95.0|0.7|2.3|||negative binomial regression|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||2.3|0.7|0.36
74032687|NCT05319535|147618410|SUPERIORITY||Odds Ratio (OR)|3.3||||0.17|TWO_SIDED|95.0|0.6|18.5|||Regression, Logistic|||Model included the arm indicator variable.||18.5|0.6|0.17
74032688|NCT04710862|147618439|SUPERIORITY||||||<|0.0005|||||||Mixed Models Analysis|||||||<0.0005
74032689|NCT04710862|147618440|SUPERIORITY||||||<|0.0005|||||||Mixed Models Analysis|||||||<0.0005
73978697|NCT03960645|147503194|OTHER||GLSM ratio (%)|64.22|||||TWO_SIDED|90.0|54.63|75.49||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||75.49|54.63|
73978698|NCT03960645|147503194|OTHER||GLSM ratio (%)|42.89|||||TWO_SIDED|90.0|36.55|50.34||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||50.34|36.55|
74032690|NCT04710862|147618441|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
74032691|NCT04710862|147618442|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74032692|NCT04710862|147618443|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
74032693|NCT04710862|147618444|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74032694|NCT04710862|147618445|SUPERIORITY|||||||0.328|||||||Mixed Models Analysis|||||||0.328
74032695|NCT02626819|147618446|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data||||||<0.05
74032696|NCT02626819|147618447|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data.||||||<0.05
74032697|NCT02626819|147618448|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data||||||<0.05
74032698|NCT02626819|147618449|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
73951088|NCT01994720|147435663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0928|TWO_SIDED|95.0|0.79|1.02|||Regression, Cox|||||1.02|0.79|0.0928
73951089|NCT01994720|147435664|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0771|TWO_SIDED|95.0|0.78|1.01|||Regression, Cox|||||1.01|0.78|0.0771
73951090|NCT01994720|147435665|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.3641|TWO_SIDED|95.0|0.83|1.67|||Regression, Cox|||||1.67|0.83|0.3641
73951091|NCT01994720|147435666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.4828|TWO_SIDED|95.0|0.75|1.85|||Regression, Cox|||||1.85|0.75|0.4828
73978699|NCT03960645|147503194|OTHER||GLSM ratio (%)|64.71|||||TWO_SIDED|90.0|59.3|70.61||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||70.61|59.30|
73978700|NCT03960645|147503194|OTHER||GLSM ratio (%)|46.92|||||TWO_SIDED|90.0|39.57|55.64||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||55.64|39.57|
74032699|NCT02626819|147618450|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74032700|NCT02626819|147618451|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74032701|NCT02626819|147618452|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74032702|NCT02626819|147618453|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
73871524|NCT00445770|147286399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
73871525|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.0001
73871526|NCT00445770|147286399|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.1740
73871527|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior Methotrexate use + treatment.||Week 2||||<0.0001
73871528|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 2||||<0.0001
73871529|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0274|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.|ANCOVA|||Week 2||||0.0274
73951092|NCT01994720|147435667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.5457|TWO_SIDED|95.0|0.67|2.14|||Regression, Cox|||||2.14|0.67|0.5457
73951093|NCT01994720|147435668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.1393|TWO_SIDED|95.0|0.85|1.02|||Regression, Logistic|||||1.02|0.85|0.1393
73951094|NCT01994720|147435669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0342|TWO_SIDED|95.0|0.75|0.99|||Regression, Cox|||||0.99|0.75|0.0342
73978701|NCT02746107|147503203|NON_INFERIORITY_OR_EQUIVALENCE|details provided in the protocol. Noninferiority margin=+/-5%|Risk Difference (RD)|0.5||||0.83|TWO_SIDED|95.0|-4.0|5.4|||Chi-squared|||||5.4|-4|0.83
73978702|NCT02746107|147503204|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.4||||0.187|TWO_SIDED|95.0|-1.3|8.1|||Chi-squared||(risk on 5y) - (risk on 1y)|details provided in protocol;||8.1|-1.3|0.187
73871530|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||<0.0001
73871531|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||<0.0001
73871532|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0344|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||0.0344
73871533|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||<0.0001
73978703|NCT02746107|147503205|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.4|||<|0.001|TWO_SIDED|95.0|10.8|20.0|||Chi-squared||patient - (physicians themselves)|||20|10.8|<0.001
73978704|NCT02746107|147503205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28|||<|0.001|TWO_SIDED|95.0|2.25|4.78|||Regression, Logistic|adjustment for age, gender, CHA2D2s-VASC score, nr of diagrams, nr of years, presence of someone close with stroke, graduation year, speciality||||4.78|2.25|<0.001
73871534|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||<0.0001
73871535|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0293|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||0.0293
73871536|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||<0.0001
73871537|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||<0.0001
73871538|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0452|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||0.0452
73871539|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||<0.0001
73871540|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||<0.0001
73871541|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0313|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||0.0313
73871542|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||<0.0001
73871543|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||0.0019
73951095|NCT01994720|147435670|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.8557|TWO_SIDED|95.0|0.55|2.06|||Regression, Cox|||||2.06|0.55|0.8557
73951096|NCT01994720|147435671|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.2126|TWO_SIDED|95.0|0.77|1.06|||Regression, Cox|||||1.06|0.77|0.2126
73951097|NCT01994720|147435677|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4511|TWO_SIDED|95.0|0.52|1.34|||Regression, Cox|||PLATO Major bleeding||1.34|0.52|0.4511
73951098|NCT01994720|147435678|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.26|||<|0.0001|TWO_SIDED|95.0|1.53|3.34|||Regression, Cox|||||3.34|1.53|<0.0001
73951099|NCT02216422|147435679|SUPERIORITY_OR_OTHER||Percentage of Participants|100.0|||||TWO_SIDED|95.0|90.4|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|||100.0|90.4|
73951100|NCT04285229|147435682|SUPERIORITY||Odds Ratio (OR)|7.64|||<|0.001|TWO_SIDED|95.0|2.68|21.76|||Regression, Logistic|||||21.76|2.68|<0.001
73951101|NCT04285229|147435683|SUPERIORITY||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.42|16.9|||Regression, Logistic|||||16.90|2.42|<0.001
73951102|NCT04285229|147435684|SUPERIORITY||Odds Ratio (OR)|2.58||||0.006|TWO_SIDED|95.0|1.31|5.09|||Regression, Logistic|||||5.09|1.31|0.006
73951103|NCT04285229|147435685|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-1.38|-0.9|||Mixed Models Analysis|||||-0.90|-1.38|<0.001
73871544|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0781|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||0.0781
73951104|NCT04285229|147435686|SUPERIORITY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.04|-0.94|||Mixed Models Analysis|||||-0.94|-2.04|<0.001
73951105|NCT04285229|147435687|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.28||0.002|TWO_SIDED|95.0|-1.43|-0.32|||Mixed Models Analysis|||||-0.32|-1.43|0.002
73951106|NCT04285229|147435688|SUPERIORITY||LS Mean Difference|-7.72|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-10.85|-4.6|||ANCOVA|||||-4.60|-10.85|<0.001
73951107|NCT04285229|147435689|SUPERIORITY||LS Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.785||0.001|TWO_SIDED|95.0|1.07|4.17|||Mixed Models Analysis|||||4.17|1.07|0.001
73978705|NCT02746107|147503206|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.3||||0.034|TWO_SIDED|95.0|1.2|17.0|||Chi-squared|CHA2D2S-VASC risk score 1 was reference|positive value means higher proportion of prescription, CHA2D2S-VASC risk score 1 was reference|CHA2D2S-VASC risk score 1 was the reference||17|1.2|0.034
73978706|NCT02746107|147503206|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.2||||0.033|TWO_SIDED|95.0|1.2|17.0|||Chi-squared|||||17|1.2|0.033
73978707|NCT02746107|147503206|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.4||||0.003|TWO_SIDED|95.0|4.7|20.1|||Chi-squared|||||20.1|4.7|0.003
73978708|NCT02746107|147503206|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.1||||0.009|TWO_SIDED|95.0|3.2|18.8|||Chi-squared|||||18.8|3.2|0.009
73978709|NCT02746107|147503206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.024|TWO_SIDED|95.0|1.08|3.07|||Regression, Logistic|CHA2D2S-VASC risk score 1 was the reference, adjusted for nr diagrams, nr years, age, gender, smb close with stroke, speciality, professional degree||CHA2D2S-VASC risk score 1 was the reference||3.07|1.08|0.024
73978710|NCT02746107|147503206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.03|TWO_SIDED|95.0|1.06|2.98|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator: CHADS-VASC 1|||2.98|1.06|0.03
73978711|NCT02746107|147503206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.002|TWO_SIDED|95.0|1.37|4.09|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator = CHADS-VASC 1|||4.09|1.37|0.002
73978712|NCT02746107|147503206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.004|TWO_SIDED|95.0|1.14|2.56|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator=CHADS-VASC 1|||2.56|1.14|0.004
73978713|NCT00403494|147503221|SUPERIORITY|PWT was transformed to the log ratio at Week 24:Baseline for statistical analysis.|Mean Difference (Final Values)|-0.021|STANDARD_DEVIATION|0.379||0.727|TWO_SIDED|95.0|-0.138|0.097|||t-test, 2 sided||Mean difference represents the difference of the means of the natural log-transformed ratios between the 2 treatment groups.|||0.097|-0.138|0.727
74032703|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8||||||95.0|-5.4|3.7||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.7|-5.4|
73978714|NCT02224755|147503242|NON_INFERIORITY|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|9.4|||<|0.001|ONE_SIDED|95.0|-2.1||||Farrington-Manning risk difference||||||-2.1|<0.001
73978715|NCT02224755|147503243|NON_INFERIORITY|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|19.2|||<|0.001|ONE_SIDED|95.0|9.8||||Farrington-Manning risk difference||||||9.8|<0.001
74032704|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-5.5||||||95.0|-14.2|3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.3|-14.2|
73871545|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||<0.0001
73871546|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||0.0001
73951108|NCT04285229|147435690|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.152||0.66|TWO_SIDED|95.0|-1.77|2.79|||Mixed Models Analysis|||||2.79|-1.77|0.660
73951109|NCT04285229|147435691|SUPERIORITY||LS Mean Difference|-12.75|STANDARD_ERROR_OF_MEAN|1.594|<|0.001|TWO_SIDED|95.0|-15.91|-9.59|||Mixed Models Analysis|||||-9.59|-15.91|<0.001
73951110|NCT04285229|147435692|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.57|-0.15|||Mixed Models Analysis|||||-0.15|-0.57|<0.001
73951111|NCT04285229|147435693|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.413||0.086|TWO_SIDED|95.0|-1.54|0.1|||Mixed Models Analysis|||||0.10|-1.54|0.086
73951112|NCT04285229|147435694|SUPERIORITY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|1.034|<|0.001|TWO_SIDED|95.0|-7.71|-3.62|||ANCOVA|||||-3.62|-7.71|<0.001
73951113|NCT03257995|147435733|OTHER||Mean Difference (Final Values)|0.1861|||<|0.001|TWO_SIDED|95.0|0.1293|0.2429|||ANOVA|||||0.2429|0.1293|<0.001
73951114|NCT03257995|147435733|OTHER||Mean Difference (Final Values)|0.1463|||<|0.001|TWO_SIDED|95.0|0.0898|0.2029|||ANOVA|||||0.2029|0.0898|<0.001
73951115|NCT03257995|147435733|OTHER||Mean Difference (Final Values)|-0.0398|||||TWO_SIDED|95.0|-0.0942|0.0147|||ANOVA|||||0.0147|-0.0942|
73951116|NCT03257995|147435739|OTHER||Median Difference (Final Values)|-0.02||||0.823|TWO_SIDED|95.0|-0.83|0.33|||Wilcoxon (Mann-Whitney)|||||0.33|-0.83|0.823
73951117|NCT03257995|147435739|OTHER||Median Difference (Final Values)|-0.02||||0.801|TWO_SIDED|95.0|-0.82|0.51|||Wilcoxon (Mann-Whitney)|||||0.51|-0.82|0.801
73871547|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.1279|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||0.1279
73871548|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||<0.0001
73978716|NCT02224755|147503244|SUPERIORITY||Risk Ratio (RR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.38|||Fisher Exact|||Based on data in the Sponsor's device tracking database, 7% of patients with the HeartMate II LVAS receive a pump replacement by 24 months. The expected proportion of patients with the HeartMate 3 LVAS to receive a pump replacement by 24 months was assumed to be 3%. We estimated that to demonstrate superiority of HeartMate 3 to HeartMate II with a power of 80% and α = 0.05 (2-sided), a total of 1028 patients (514 per arm) were required using the Fisher's exact test.||.38|.11|<0.001
73978717|NCT01852045|147503252|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.276||0.9949|TWO_SIDED|95.0|-0.549|0.545|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||0.545|-0.549|0.9949
73978718|NCT01852045|147503252|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.321||0.9123|TWO_SIDED|95.0|-0.673|0.602|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||0.602|-0.673|0.9123
73978719|NCT01852045|147503254|SUPERIORITY||Least Squares Mean Difference|12.97|STANDARD_ERROR_OF_MEAN|19.694||0.5117|TWO_SIDED|95.0|-26.12|52.064|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||52.064|-26.120|0.5117
73978720|NCT01852045|147503254|SUPERIORITY||Least Squares Mean Difference|65.57|STANDARD_ERROR_OF_MEAN|23.101||0.0055|TWO_SIDED|95.0|19.711|111.421|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||111.421|19.711|0.0055
73978721|NCT01852045|147503256|SUPERIORITY||Least Squares Mean Difference|-13.49|STANDARD_ERROR_OF_MEAN|19.673||0.4948|TWO_SIDED|95.0|-52.605|25.626|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||25.626|-52.605|0.4948
74032705|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-3.7|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.8|-3.7|
73978722|NCT01852045|147503256|SUPERIORITY||Least Squares Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|22.382||0.9471|TWO_SIDED|95.0|-43.012|45.991|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||45.991|-43.012|0.9471
73978723|NCT01852045|147503257|SUPERIORITY||Relative Risk|0.7||||0.2027|TWO_SIDED|95.0|0.45|1.14||P-values for pairwise comparisons are obtained from 2-sided CMH test, stratified by age (\<12 years or \>=12 years), baseline daytime urinary incontinence episodes (\<=6 or \>6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6||1.14|0.45|0.2027
73978724|NCT01852045|147503257|SUPERIORITY||Relative Risk|0.8||||0.1564|TWO_SIDED|95.0|0.4|1.21||P-values for pairwise comparisons are obtained from a 2-sided CMH test, stratified by age (\< 12 years or \>= 12 years), baseline daytime urinary incontinence episodes (\<= 6 or \> 6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6||1.21|0.40|0.1564
73978725|NCT01852045|147503258|SUPERIORITY||Least Squares Mean Difference|-4.49|STANDARD_ERROR_OF_MEAN|7.488||0.5524|TWO_SIDED|95.0|-19.648|10.669|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||10.669|-19.648|0.5524
73978726|NCT01852045|147503258|SUPERIORITY||Least Squares Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|10.181||0.8313|TWO_SIDED|95.0|-18.427|22.795|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||22.795|-18.427|0.8313
73978727|NCT01852045|147503259|SUPERIORITY||Least Squares Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|5.253||0.1737|TWO_SIDED|95.0|-17.653|3.238|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||3.238|-17.653|0.1737
74032706|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-2.9||||||95.0|-6.9|0.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.7|-6.9|
74032707|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-3.0|3.0||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.0|-3.0|
73871549|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||0.0004
73871550|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0807|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||0.0807
73871551|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||<0.0001
73871552|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||0.0002
74089394|NCT02697773|147731621|SUPERIORITY||Least Square Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.29|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.48|-1.29|<.0001
74089395|NCT02697773|147731621|SUPERIORITY||Least Square Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.46|-0.63|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.63|-1.46|<.0001
73951118|NCT03257995|147435739|OTHER||Median Difference (Final Values)|0.0||||0.984|TWO_SIDED|95.0|-0.5|0.73|||Wilcoxon (Mann-Whitney)|||||0.73|-0.50|0.984
73951119|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2177|||<|0.001|TWO_SIDED|95.0|0.1482|0.2872|||ANOVA|||at 5 min||0.2872|0.1482|<0.001
73951120|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2724|||<|0.001|TWO_SIDED|95.0|0.203|0.3417|||ANOVA|||15min||0.3417|0.2030|<0.001
73951121|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.273|||<|0.001|TWO_SIDED|95.0|0.2036|0.3423|||ANOVA|||30 min||0.3423|0.2036|<0.001
73951122|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2609|||<|0.001|TWO_SIDED|95.0|0.1915|0.3302|||ANOVA|||1 hour||0.3302|0.1915|<0.001
73951123|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2494|||<|0.001|TWO_SIDED|95.0|0.18|0.3188|||ANOVA|||2 hour||0.3188|0.1800|<0.001
73951124|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2273|||<|0.001|TWO_SIDED|95.0|0.1578|0.2968|||ANOVA|||4 hour||0.2968|0.1578|<0.001
73951125|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2396|||<|0.001|TWO_SIDED|95.0|0.1697|0.3096|||ANOVA|||8 hour||0.3096|0.1697|<0.001
73871553|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.418|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||0.4180
73951126|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2443|||<|0.001|TWO_SIDED|95.0|0.1742|0.3144|||ANOVA|||12 hour||0.3144|0.1742|<0.001
73951127|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.228|||<|0.001|TWO_SIDED|95.0|0.1563|0.2997|||ANOVA|||23 hour 15 min||0.2997|0.1563|<0.001
73951128|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.1954|||<|0.001|TWO_SIDED|95.0|0.1237|0.2671|||ANOVA|||23 hour 45 min||0.2671|0.1237|<0.001
73951129|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2195|||<|0.001|TWO_SIDED|95.0|0.1502|0.2889|||ANOVA|||5 min||0.2889|0.1502|<0.001
73951130|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2684|||<|0.001|TWO_SIDED|95.0|0.1988|0.338|||ANOVA|||15 min||0.3380|0.1988|<0.001
73951131|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2572|||<|0.001|TWO_SIDED|95.0|0.1879|0.3266|||ANOVA|||30 min||0.3266|0.1879|<0.001
73951132|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2348|||<|0.001|TWO_SIDED|95.0|0.1656|0.304|||ANOVA|||1 hour||0.3040|0.1656|<0.001
73951133|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2546|||<|0.001|TWO_SIDED|95.0|0.1852|0.3239|||ANOVA|||2 hour||0.3239|0.1852|<0.001
73951134|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2322|||<|0.001|TWO_SIDED|95.0|0.1627|0.3017|||ANOVA|||4 hour||0.3017|0.1627|<0.001
73951135|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2324|||<|0.001|TWO_SIDED|95.0|0.1627|0.302|||ANOVA|||8 hour||0.3020|0.1627|<0.001
73951136|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.2057|||<|0.001|TWO_SIDED|95.0|0.1359|0.2755|||ANOVA|||12 hour||0.2755|0.1359|<0.001
73951137|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.1625|||<|0.001|TWO_SIDED|95.0|0.0912|0.2337|||ANOVA|||23 hour 15 min||0.2337|0.0912|<0.001
73951138|NCT03257995|147435740|OTHER||Mean Difference (Final Values)|0.1793|||<|0.001|TWO_SIDED|95.0|0.108|0.2505|||ANOVA|||23 hour 45 min||0.2505|0.1080|<0.001
73951139|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.2|||ANOVA|||at 5 min||9.2|5.0|<.001
73951140|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|8.5|||<|0.001|TWO_SIDED|95.0|6.4|10.6|||ANOVA|||at 15 min||10.6|6.4|<.001
73951141|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|8.6|||<|0.001|TWO_SIDED|95.0|6.5|10.7|||ANOVA|||at 30||10.7|6.5|<0.001
73951142|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|8.0|||<|0.001|TWO_SIDED|95.0|6.0|10.1|||ANOVA|||at 1 hour||10.1|6.0|<0.001
73951143|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|5.5|9.7|||ANOVA|||at 2 hours||9.7|5.5|<0.001
73951144|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.1|||ANOVA|||at 4 hours||9.1|5.0|<0.001
73951145|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|7.3|||<|0.001|TWO_SIDED|95.0|5.2|9.4|||ANOVA|||at 8 hours||9.4|5.2|<0.001
73951146|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|5.5|9.7|||ANOVA|||at 12 hours||9.7|5.5|<0.001
73951147|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|7.0|||<|0.001|TWO_SIDED|95.0|4.8|9.1|||ANOVA|||at 23 hours 15 min||9.1|4.8|<0.001
73951148|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|6.4|||<|0.001|TWO_SIDED|95.0|4.2|8.6|||ANOVA|||at 23 hours 45 min||8.6|4.2|<0.001
73951149|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.2|||ANOVA|||at 5 min||9.2|5.0|<0.001
73951150|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|8.3|||<|0.001|TWO_SIDED|95.0|6.2|10.4|||ANOVA|||at 15 min||10.4|6.2|<0.001
73951151|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|8.1|||<|0.001|TWO_SIDED|95.0|6.0|10.2|||ANOVA|||at 30 min||10.2|6.0|<0.001
73951152|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|95.0|5.3|9.4|||ANOVA|||at 1 hour||9.4|5.3|<0.001
73951153|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|7.8|||<|0.001|TWO_SIDED|95.0|5.7|9.9|||ANOVA|||at 2 hours||9.9|5.7|<0.001
73951154|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|7.3|||<|0.001|TWO_SIDED|95.0|5.2|9.4|||ANOVA|||at 4 hours||9.4|5.2|<0.001
73951155|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|95.0|5.3|9.5|||ANOVA|||at 8 hours||9.5|5.3|<0.001
73951156|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|6.3|||<|0.001|TWO_SIDED|95.0|4.2|8.4|||ANOVA|||at 12 hours||8.4|4.2|<0.001
73951157|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|5.1|||<|0.001|TWO_SIDED|95.0|2.9|7.2|||ANOVA|||at 23 hours 15 min||7.2|2.9|<0.001
73951158|NCT03257995|147435741|OTHER||Mean Difference (Final Values)|5.9|||<|0.001|TWO_SIDED|95.0|3.7|8.0|||ANOVA|||at 23 hours 45 min||8.0|3.7|<0.001
73978728|NCT01852045|147503259|SUPERIORITY||Least Squares Mean Difference|-14.43|STANDARD_ERROR_OF_MEAN|5.85||0.0157|TWO_SIDED|95.0|-26.061|-2.793|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||-2.793|-26.061|0.0157
73951159|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.1866|||<|0.001|TWO_SIDED|95.0|0.1121|0.2611|||ANOVA|||5 min||0.2611|0.1121|<0.001
73978729|NCT02736188|147503264|SUPERIORITY||LS Mean Difference|0.8||||0.4287|TWO_SIDED|95.0|-1.17|2.77||Baseline is fit into the model as a covariate.|generalized estimating equation (GEE)|||Week 8||2.77|-1.17|0.4287
73978730|NCT02736188|147503264|SUPERIORITY||LS Mean Difference|0.36||||0.7031|TWO_SIDED|95.0|-1.49|2.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.21|-1.49|0.7031
73978731|NCT02736188|147503264|SUPERIORITY||LS Mean Difference|-0.91||||0.4253|TWO_SIDED|95.0|-3.14|1.32||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.32|-3.14|0.4253
73978732|NCT02736188|147503264|SUPERIORITY||LS Mean Difference|-0.06||||0.9747|TWO_SIDED|95.0|-3.49|3.38||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.38|-3.49|0.9747
73978733|NCT02736188|147503265|SUPERIORITY||LS Mean Difference|-0.27||||0.4721|TWO_SIDED|95.0|-1.01|0.47||Baseline is fit into the model as a covariate.|GEE model|||Week 8||0.47|-1.01|0.4721
73951160|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.2249|||<|0.001|TWO_SIDED|95.0|0.1506|0.2992|||ANOVA|||15 min||0.2992|0.1506|<0.001
73951161|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.2404|||<|0.001|TWO_SIDED|95.0|0.1661|0.3148|||ANOVA|||30 min||0.3148|0.1661|<0.001
73951162|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.2074|||<|0.001|TWO_SIDED|95.0|0.133|0.2817|||ANOVA|||1 hour||0.2817|0.1330|<0.001
73951163|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.1802|||<|0.001|TWO_SIDED|95.0|0.1059|0.2545|||ANOVA|||2 hours||0.2545|0.1059|<0.001
73951164|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.1621|||<|0.001|TWO_SIDED|95.0|0.0876|0.2366|||ANOVA|||4 hours||0.2366|0.0876|<0.001
73951165|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.199|||<|0.001|TWO_SIDED|95.0|0.1239|0.2742|||ANOVA|||8 hours||0.2742|0.1239|<0.001
73951166|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.1747|||<|0.001|TWO_SIDED|95.0|0.0994|0.2501|||ANOVA|||12 hours||0.2501|0.0994|<0.001
73951167|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.1856|||<|0.001|TWO_SIDED|95.0|0.1081|0.2631|||ANOVA|||23 hours 15 min||0.2631|0.1081|<0.001
73951168|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.1484|||<|0.001|TWO_SIDED|95.0|0.0709|0.2259|||ANOVA|||23 hours 45 min||0.2259|0.0709|<0.001
73951169|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.1386|0.2873|||ANOVA|||5 min||0.2873|0.1386|<0.001
73951170|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.2173|||<|0.001|TWO_SIDED|95.0|0.1426|0.292|||ANOVA|||15 min||0.2920|0.1426|<0.001
73951171|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.2375|||<|0.001|TWO_SIDED|95.0|0.1632|0.3118|||ANOVA|||30 min||0.3118|0.1632|<0.001
73951172|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.2013|||<|0.001|TWO_SIDED|95.0|0.1272|0.2754|||ANOVA|||1 hour||0.2754|0.1272|<0.001
73951173|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.2005|||<|0.001|TWO_SIDED|95.0|0.1262|0.2749|||ANOVA|||2 hours||0.2749|0.1262|<0.001
73951174|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.1946|||<|0.001|TWO_SIDED|95.0|0.1201|0.2691|||ANOVA|||4 hours||0.2691|0.1201|<0.001
73951175|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.1937|||<|0.001|TWO_SIDED|95.0|0.119|0.2684|||ANOVA|||8 hours||0.2684|0.1190|<0.001
73951176|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.1619|||<|0.001|TWO_SIDED|95.0|0.087|0.2369|||ANOVA|||12 hour||0.2369|0.0870|<0.001
73951177|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.1249|||<|0.001|TWO_SIDED|95.0|0.048|0.2018|||ANOVA|||23 hour 15 min||0.2018|0.0480|<0.001
73951178|NCT03257995|147435742|OTHER||Mean Difference (Final Values)|0.1546|||<|0.001|TWO_SIDED|95.0|0.0777|0.2315|||ANOVA|||23 hour 45 min||0.2315|0.0777|<0.001
73951179|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.1|7.0|||ANOVA|||5 min||7.0|3.1|<0.001
73951180|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|6.0|||<|0.001|TWO_SIDED|95.0|4.0|7.9|||ANOVA|||15 min||7.9|4|<0.001
73951181|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|6.6|||<|0.001|TWO_SIDED|95.0|4.6|8.5|||ANOVA|||30 min||8.5|4.6|<0.001
73951182|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.4|||ANOVA|||1 hour||7.4|3.5|<0.001
73951183|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|4.7|||<|0.001|TWO_SIDED|95.0|2.8|6.7|||ANOVA|||2 hour||6.7|2.8|<0.001
73951184|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|4.3|||<|0.001|TWO_SIDED|95.0|2.3|6.3|||ANOVA|||4 hour||6.3|2.3|<0.001
73951185|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.0|7.0|||ANOVA|||8 hour||7|3|<0.001
73951186|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|4.5|||<|0.001|TWO_SIDED|95.0|2.5|6.5|||ANOVA|||12 hour||6.5|2.5|<0.001
73951187|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|4.6|||<|0.001|TWO_SIDED|95.0|2.6|6.7|||ANOVA|||23 hour 15 min||6.7|2.6|<0.001
73951188|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|4.1|||<|0.001|TWO_SIDED|95.0|2.0|6.2|||ANOVA|||23 hour 45 min||6.2|2.0|<0.001
73951189|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.9|7.8|||ANOVA|||5 min||7.8|3.9|<0.001
73951190|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.9|7.8|||ANOVA|||15 min||7.8|3.9|<0.001
73951191|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|6.3|||<|0.001|TWO_SIDED|95.0|4.4|8.3|||ANOVA|||30 min||8.3|4.4|<0.001
73951192|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.5|||ANOVA|||1 hour||7.5|3.5|<0.001
73951193|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.4|||ANOVA|||2 hour||7.4|3.5|<0.001
73951194|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.1|7.0|||ANOVA|||4 hour||7.0|3.1|<0.001
73951195|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.0|7.0|||ANOVA|||8 hour||7.0|3.0|<0.001
73951196|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|4.2|||<|0.001|TWO_SIDED|95.0|2.2|6.2|||ANOVA|||12 hour||6.2|2.2|<0.001
73951197|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|3.0||||0.004|TWO_SIDED|95.0|1.0|5.0|||ANOVA|||23 hour 15 min||5.0|1.0|0.004
73951198|NCT03257995|147435743|OTHER||Mean Difference (Final Values)|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||ANOVA|||23 hour 45 min||6.1|2.1|<0.001
73951199|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0249|||<|0.001|TWO_SIDED|95.0|0.0139|0.0359|||ANOVA|||5 min||0.0359|0.0139|<.001
73978734|NCT02736188|147503265|SUPERIORITY||LS Mean Difference|-0.19||||0.6611|TWO_SIDED|95.0|-1.02|0.64||Baseline is fit into the model as a covariate.|GEE model|||Week 16||0.64|-1.02|0.6611
73978735|NCT02736188|147503265|SUPERIORITY||LS Mean Difference|-0.44||||0.276|TWO_SIDED|95.0|-1.22|0.35|||GEE model|Baseline is fit into the model as a covariate.||Week 24||0.35|-1.22|0.2760
73951200|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.033|||<|0.001|TWO_SIDED|95.0|0.022|0.044|||ANOVA|||15 min||0.0440|0.0220|<.001
73951201|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0306|||<|0.001|TWO_SIDED|95.0|0.0197|0.0416|||ANOVA|||30 min||0.0416|0.0197|<0.001
73951202|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0324|||<|0.001|TWO_SIDED|95.0|0.0214|0.0434|||ANOVA|||1 hour||0.0434|0.0214|<0.001
73951203|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0338|||<|0.001|TWO_SIDED|95.0|0.0228|0.0447|||ANOVA|||2 hour||0.0447|0.0228|<0.001
73951204|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0325|||<|0.001|TWO_SIDED|95.0|0.0215|0.0435|||ANOVA|||4 hour||0.0435|0.0215|<0.001
73951205|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0311|||<|0.001|TWO_SIDED|95.0|0.02|0.0422|||ANOVA|||8 hour||0.0422|0.0200|<0.001
73951206|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0359|||<|0.001|TWO_SIDED|95.0|0.0248|0.047|||ANOVA|||12 hour||0.0470|0.0248|<0.001
73951207|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0326|||<|0.001|TWO_SIDED|95.0|0.0211|0.044|||ANOVA|||23 hour 15 min||0.0440|0.0211|<0.001
73951208|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0301|||<|0.001|TWO_SIDED|95.0|0.0187|0.0415|||ANOVA|||23 hour 45 min||0.0415|0.0187|<0.001
73951209|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0222|||<|0.001|TWO_SIDED|95.0|0.0113|0.0332|||ANOVA|||5 min||0.0332|0.0113|<0.001
73951210|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0344|||<|0.001|TWO_SIDED|95.0|0.0234|0.0454|||ANOVA|||15 min||0.0454|0.0234|<0.001
73951211|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.029|||<|0.001|TWO_SIDED|95.0|0.018|0.0399|||ANOVA|||30 min||0.0399|0.0180|<0.001
73951212|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0278|||<|0.001|TWO_SIDED|95.0|0.0169|0.0387|||ANOVA|||1 hour||0.0387|0.0169|<0.001
73951213|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0338|||<|0.001|TWO_SIDED|95.0|0.0228|0.0447|||ANOVA|||2 hour||0.0447|0.0228|<0.001
73951214|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0278|||<|0.001|TWO_SIDED|95.0|0.0168|0.0387|||ANOVA|||4 hour||0.0387|0.0168|<0.001
73951215|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0316|||<|0.001|TWO_SIDED|95.0|0.0206|0.0426|||ANOVA|||8 hour||0.0426|0.0206|<0.001
73951216|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0285|||<|0.001|TWO_SIDED|95.0|0.0175|0.0396|||ANOVA|||12 hour||0.0396|0.0175|<0.001
73951217|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0281|||<|0.001|TWO_SIDED|95.0|0.0167|0.0394|||ANOVA|||23 hour 15 min||0.0394|0.0167|<0.001
73951218|NCT03257995|147435744|OTHER||Mean Difference (Final Values)|0.0266|||<|0.001|TWO_SIDED|95.0|0.0152|0.0379|||ANOVA|||23 hour 45 min||0.0379|0.0152|<0.001
73951219|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2025|||<|0.001|TWO_SIDED|95.0|0.1059|0.2952|||ANOVA|||5 min||0.2952|0.1059|<0.001
73951220|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2923|||<|0.001|TWO_SIDED|95.0|0.1979|0.3867|||ANOVA|||15 min||0.3867|0.1979|<0.001
73951221|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2657|||<|0.001|TWO_SIDED|95.0|0.1713|0.3601|||ANOVA|||30 min||0.3601|0.1713|<0.001
73951222|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2752|||<|0.001|TWO_SIDED|95.0|0.1808|0.3696|||ANOVA|||1 hour||0.3696|0.1808|<0.001
73951223|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2819|||<|0.001|TWO_SIDED|95.0|0.1875|0.3763|||ANOVA|||2 hours||0.3763|0.1875|<0.001
73951224|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.282|||<|0.001|TWO_SIDED|95.0|0.1874|0.3766|||ANOVA|||4 hours||0.3766|0.1874|<0.001
73951225|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2538|||<|0.001|TWO_SIDED|95.0|0.1585|0.3492|||ANOVA|||8 hours||0.3492|0.1585|<0.001
73951226|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2687|||<|0.001|TWO_SIDED|95.0|0.1732|0.3643|||ANOVA|||12 hours||0.3643|0.1732|<0.001
73951227|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2453|||<|0.001|TWO_SIDED|95.0|0.1473|0.3434|||ANOVA|||23 hours 15 min||0.3434|0.1473|<0.001
73951228|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.1862|||<|0.001|TWO_SIDED|95.0|0.0882|0.2842|||ANOVA|||23 hours 45 min||0.2842|0.0882|<0.001
73951229|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.1956|||<|0.001|TWO_SIDED|95.0|0.1012|0.2899|||ANOVA|||5 min||0.2899|0.1012|<0.001
73951230|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2927|||<|0.001|TWO_SIDED|95.0|0.1979|0.3875|||ANOVA|||15 min||0.3875|0.1979|<0.001
73951231|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2723|||<|0.001|TWO_SIDED|95.0|0.178|0.3667|||ANOVA|||30 min||0.3667|0.1780|<0.001
73871554|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||<0.0001
73871555|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||0.0061
73871556|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.1615|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||0.1615
73871557|NCT00445770|147286400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||<0.0001
73951232|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2386|||<|0.001|TWO_SIDED|95.0|0.1445|0.3328|||ANOVA|||1 hour||0.3328|0.1445|<0.001
73951233|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2986|||<|0.001|TWO_SIDED|95.0|0.2042|0.393|||ANOVA|||2 hours||0.3930|0.2042|<0.001
73871558|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||0.0130
73951234|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2661|||<|0.001|TWO_SIDED|95.0|0.1715|0.3607|||ANOVA|||4 hours||0.3607|0.1715|<0.001
73951235|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2558|||<|0.001|TWO_SIDED|95.0|0.1609|0.3506|||ANOVA|||8 hours||0.3506|0.1609|<0.001
73951236|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.1987|||<|0.001|TWO_SIDED|95.0|0.1036|0.2938|||ANOVA|||12 hours||0.2938|0.1036|<0.001
73978736|NCT02736188|147503265|SUPERIORITY||LS Mean Difference|-0.28||||0.6977|TWO_SIDED|95.0|-1.69|1.13||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.13|-1.69|0.6977
73978737|NCT02736188|147503266|SUPERIORITY||Difference in LS Means|0.7||||0.0648|TWO_SIDED|95.0|-0.04|1.45||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.45|-0.04|0.0648
73978738|NCT02736188|147503266|SUPERIORITY||difference in LS means|0.74||||0.0692|TWO_SIDED|95.0|-0.06|1.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.55|-0.06|0.0692
73978739|NCT02736188|147503266|SUPERIORITY||difference in LS means|0.44||||0.4317|TWO_SIDED|95.0|-0.65|1.52||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.52|-0.65|0.4317
73978740|NCT02736188|147503266|SUPERIORITY||difference in LS means|-0.34||||0.6416|TWO_SIDED|95.0|-1.78|1.1||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.10|-1.78|0.6416
73871559|NCT00445770|147286400|SUPERIORITY_OR_OTHER|||||||0.0948|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||0.0948
73871560|NCT03857542|147286402|SUPERIORITY||Percentage Difference|15.2|||<|0.0001|TWO_SIDED|95.0|7.7|22.7||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion differences were calculated based on the normal approximation based on pooled variance without continuity correction.|||22.7|7.7|<.0001
73871561|NCT03857542|147286403|SUPERIORITY||Percentage Difference|6.5||||0.0548|TWO_SIDED|95.0|-0.1|13.1||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion difference was calculated based on the normal approximation based on pooled variance without continuity correction.|||13.1|-0.1|0.0548
73871562|NCT03857542|147286404|SUPERIORITY||Percentage Difference|5.9||||0.0693|TWO_SIDED|95.0|-0.5|12.2||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion difference was calculated based on the normal approximation based on pooled variance without continuity correction.|||12.2|-0.5|0.0693
73871563|NCT03857542|147286405|SUPERIORITY||Least Squares (LS) Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|2.9|5.2||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value; Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||5.2|2.9|<.0001
73951237|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.2044|||<|0.001|TWO_SIDED|95.0|0.1071|0.3017|||ANOVA|||23 hours 15 min||0.3017|0.1071|<0.001
73951238|NCT03257995|147435745|OTHER||Mean Difference (Final Values)|0.1997|||<|0.001|TWO_SIDED|95.0|0.1023|0.297|||ANOVA|||23 hours 45 min||0.2970|0.1023|<0.001
73951239|NCT03257995|147435746|OTHER||Mean Difference (Final Values)|0.2476|||<|0.001|TWO_SIDED|95.0|0.1857|0.3095|||ANOVA|||||0.3095|0.1857|<.001
73951240|NCT03257995|147435746|OTHER||Mean Difference (Final Values)|0.2448|||<|0.001|TWO_SIDED|95.0|0.183|0.3066|||ANOVA|||||0.3066|0.1830|<.001
73951241|NCT03257995|147435746|OTHER||Mean Difference (Net)|-0.0028|||||TWO_SIDED|95.0|-0.0647|0.059|||ANOVA|||||0.0590|-0.0647|
73951242|NCT03257995|147435747|OTHER||Mean Difference (Final Values)|-0.42||||0.009|TWO_SIDED|95.0|-0.73|0.11|||ANOVA|||||0.11|-0.73|0.009
73951243|NCT03257995|147435747|OTHER||Mean Difference (Final Values)|-0.42||||0.008|TWO_SIDED|95.0|-0.73|0.11|||ANOVA|||||0.11|-0.73|0.008
73951244|NCT03257995|147435748|OTHER||Mean Difference (Final Values)|33.0|||<|0.001|TWO_SIDED|95.0|25.6|40.3|||ANOVA|||||40.3|25.6|<0.001
73951245|NCT03257995|147435748|OTHER||Mean Difference (Final Values)|30.8|||<|0.001|TWO_SIDED|95.0|23.5|38.2|||ANOVA|||||38.2|23.5|<0.001
73951246|NCT02258464|147435754|OTHER||Hazard Ratio (Radium 223/Placebo)|0.745||||0.3339|TWO_SIDED|80.0|0.504|1.102||The SSE-FS was compared using a stratified log-rank test with a 2-sided alpha of 0.2|Log Rank|||The null hypothesis that both treatment groups have the same SSE-FS distribution will be tested against the alternative hypothesis that the distribution of SSE-FS time in radium-223 dichloride is different from the placebo group||1.102|0.504|0.3339
73951247|NCT02258464|147435755|OTHER||Hazard ratio (Radium 223/Placebo)|0.888||||0.7259|TWO_SIDED|80.0|0.576|1.37|||Log Rank|||||1.370|0.576|0.7259
73951248|NCT02258464|147435756|OTHER||Hazard ratio (Radium 223/Placebo)|0.932||||0.8785|TWO_SIDED|80.0|0.513|1.693|||Log Rank|||||1.693|0.513|0.8785
73951249|NCT02258464|147435757|OTHER||Hazard ratio (Radium 223/Placebo)|0.824||||0.524|TWO_SIDED|80.0|0.556|1.22|||Log Rank|||||1.220|0.556|0.5240
73951250|NCT02258464|147435758|OTHER||Difference (Radium 223 - Placebo) %|11.8||||0.345|TWO_SIDED|80.0|-2.7|26.3|||Cochran-Mantel-Haenszel|||||26.3|-2.7|0.345
73951251|NCT02258464|147435759|OTHER||Hazard ratio (Radium 223/Placebo)|0.968||||0.9128|TWO_SIDED|80.0|0.657|1.425|||Log Rank|||||1.425|0.657|0.9128
73951252|NCT02258464|147435760|OTHER||Hazard ratio (Radium 223/Placebo)|1.023||||0.9227|TWO_SIDED|80.0|0.753|1.391|||Log Rank|||||1.391|0.753|0.9227
73951253|NCT02138747|147435763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|0.997||0.004|TWO_SIDED|95.0|-4.86|-0.93||p-value based on the ANOVA model|ANOVA|||Tolerability score was analyzed using the ANOVA model (Model #1), with sequence group, study period, period-by-sequence interaction, gender and treatment group as factors, and subject-within-sequence as a random term. p-value based on the ANOVA model. Difference used mirabegron as the reference (difference =tolterodine ER -mirabegron). A negative difference indicates better reported tolerability with mirabegron than with tolterodine ER.||-0.93|-4.86|0.004
73951254|NCT02138747|147435764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||P value was obtained using Mainland-Gart test to compare the proportion of preference for each treatment group. The denominator excluded patients with No Preference.|Mainland-Gart|||Participants who selected Mirabegron or Tolterodine ER were included in the denominator and participants with No Preference were excluded. Comparison was between Mirabegron vs Tolterodine ER.||||0.77
73951255|NCT02138747|147435773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.224||0.971|TWO_SIDED|95.0|-0.39|0.49||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER - mirabegron).||0.49|-0.39|0.971
73951256|NCT02138747|147435774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.199||0.211|TWO_SIDED|95.0|-0.28|0.5||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER - mirabegron).||0.50|-0.28|0.211
73951257|NCT00932646|147435787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.139|0.205|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.205|0.139|<0.0001
73951258|NCT00932646|147435787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.14|0.208|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.208|0.140|<0.0001
73951259|NCT00932646|147435787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.124|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.124|<0.0001
73978741|NCT02736188|147503267|SUPERIORITY||difference in LS means|0.78||||0.6546|TWO_SIDED|95.0|-2.65|4.22||Baseline is fit into the model as a covariate.|GEE model|||Week 8||4.22|-2.65|0.6546
73978742|NCT02736188|147503267|SUPERIORITY||difference in LS means|-0.64||||0.7054|TWO_SIDED|95.0|-3.97|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.69|-3.97|0.7054
73978743|NCT02736188|147503267|SUPERIORITY||difference in LS means|-0.5||||0.8441|TWO_SIDED|95.0|-5.45|4.45||Baseline is fit into the model as a covariate.|GEE model|||Week 24||4.45|-5.45|0.8441
73978744|NCT02736188|147503267|SUPERIORITY||difference in LS means|4.15||||0.0864|TWO_SIDED|95.0|-0.59|8.9||Baseline is fit into the model as a covariate.|GEE model|||Week 48||8.90|-0.59|0.0864
73978745|NCT02736188|147503268|SUPERIORITY||difference in LS means|0.06||||0.8603|TWO_SIDED|95.0|-0.65|0.78||Baseline is fit into the model as a covariate.|GEE model|||Week 8||0.78|-0.65|0.8603
73978746|NCT02736188|147503268|SUPERIORITY||difference in LS means|-0.18||||0.6154|TWO_SIDED|95.0|-0.86|0.51||Baseline is fit into the model as a covariate.|GEE model|||Week 16||0.51|-0.86|0.6154
73978747|NCT02736188|147503268|SUPERIORITY||difference in LS means|0.47||||0.1999|TWO_SIDED|95.0|-0.25|1.2||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.20|-0.25|0.1999
73978748|NCT02736188|147503268|SUPERIORITY||difference in LS means|-0.03||||0.9568|TWO_SIDED|95.0|-1.25|1.18||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.18|-1.25|0.9568
73978749|NCT02736188|147503269|SUPERIORITY||difference in LS means|0.45||||0.5447|TWO_SIDED|95.0|-1.0|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.90|-1.00|0.5447
73978750|NCT02736188|147503269|SUPERIORITY||difference in LS means|-0.56||||0.5051|TWO_SIDED|95.0|-2.22|1.09||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.09|-2.22|0.5051
73951260|NCT00932646|147435788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.114|0.176|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.114|<0.0001
73978751|NCT02736188|147503269|SUPERIORITY||difference in LS means|0.27||||0.7478|TWO_SIDED|95.0|-1.36|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.90|-1.36|0.7478
73978752|NCT02736188|147503269|SUPERIORITY||difference in LS means|-0.41||||0.7429|TWO_SIDED|95.0|-2.86|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 48||2.04|-2.86|0.7429
73951261|NCT00932646|147435788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.116|0.179|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.179|0.116|<0.0001
73951262|NCT00932646|147435788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.125|0.187|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.187|0.125|<0.0001
73951263|NCT00932646|147435789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.149|0.223|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.223|0.149|<0.0001
73951264|NCT00932646|147435789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.162|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.235|0.162|<0.0001
73951265|NCT00932646|147435789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.176|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.250|0.176|<0.0001
73951266|NCT00932646|147435790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.154|0.23|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.230|0.154|<0.0001
73951267|NCT00932646|147435790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.197|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.158|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.235|0.158|<0.0001
73951268|NCT00932646|147435790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.178|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.255|0.178|<0.0001
73871564|NCT03857542|147286406|SUPERIORITY||Percentage Difference|9.9||||0.0141|TWO_SIDED|95.0|3.5|16.3||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals was calculated based on normal approximation based on pooled variance without continuity correction.|||16.3|3.5|0.0141
73871565|NCT03857542|147286407|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.5|1.0||Analysis of covariance (ANCOVA) with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control||||1.0|0.5|<.0001
73951269|NCT00932646|147435791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.026||0.0003||95.0|0.045|0.148|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.148|0.045|0.0003
73951270|NCT00932646|147435791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.026||0.0001||95.0|0.051|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.155|0.051|0.0001
73951271|NCT00932646|147435791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.026||0.0026||95.0|0.028|0.132|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.132|0.028|0.0026
73951272|NCT00932646|147435792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.195|0.306|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.306|0.195|<0.0001
73978753|NCT02736188|147503270|SUPERIORITY||difference in LS means|2.0||||0.6434|TWO_SIDED|95.0|-6.48|10.49||Baseline is fit into the model as a covariate.|GEE model|||Week 8||10.49|-6.48|0.6434
73978754|NCT02736188|147503270|SUPERIORITY||difference in LS means|-1.99||||0.7118|TWO_SIDED|95.0|-12.53|8.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16||8.55|-12.53|0.7118
73978755|NCT02736188|147503270|SUPERIORITY||difference in LS means|4.15||||0.4399|TWO_SIDED|95.0|-6.39|14.69||Baseline is fit into the model as a covariate.|GEE model|||Week 24||14.69|-6.39|0.4399
73978756|NCT02736188|147503270|SUPERIORITY||difference in LS means|7.98||||0.443|TWO_SIDED|95.0|-12.41|28.37||Baseline is fit into the model as a covariate.|GEE model|||Week 48||28.37|-12.41|0.4430
73978757|NCT02736188|147503271|SUPERIORITY||difference in LS means|0.28||||0.6428|TWO_SIDED|95.0|-0.9|1.46||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.46|-0.90|0.6428
73871566|NCT03857542|147286408|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|2.4|4.4||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||4.4|2.4|<.0001
73951273|NCT00932646|147435792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.246|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.19|0.302|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.302|0.190|<0.0001
73951274|NCT00932646|147435792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.179|0.291|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.291|0.179|<0.0001
73951275|NCT00932646|147435793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.101|0.222|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.222|0.101|<0.0001
73951276|NCT00932646|147435793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.096|0.218|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.218|0.096|<0.0001
73951277|NCT00932646|147435793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.162|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.284|0.162|<0.0001
73951278|NCT00932646|147435794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.155|0.258|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.258|0.155|<0.0001
73951279|NCT00932646|147435794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.15|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.255|0.150|<0.0001
73951280|NCT00932646|147435794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.176|0.281|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.281|0.176|<0.0001
73871567|NCT03857542|147286409|SUPERIORITY||Percentage Difference|3.8||||0.22|TWO_SIDED|95.0|-2.3|10.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals for the proportion differences were calculated based on the normal approximation based on pooled variance without continuity correction.|||10.0|-2.3|0.2200
73951281|NCT00932646|147435795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.233|0.365|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.365|0.233|<0.0001
73951282|NCT00932646|147435795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.236|0.369|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.369|0.236|<0.0001
73951283|NCT00932646|147435795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.338|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.271|0.405|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.405|0.271|<0.0001
73951284|NCT00932646|147435796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.055||0.0163||95.0|0.024|0.239|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.239|0.024|0.0163
73951285|NCT00932646|147435796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.055||0.0118||95.0|0.031|0.247|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.247|0.031|0.0118
73951286|NCT00932646|147435796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.055||0.0076||95.0|0.04|0.256|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.256|0.040|0.0076
73978758|NCT02736188|147503271|SUPERIORITY||difference in LS means|-0.25||||0.7334|TWO_SIDED|95.0|-1.72|1.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.21|-1.72|0.7334
73978759|NCT02736188|147503271|SUPERIORITY||difference in LS means|0.58||||0.4409|TWO_SIDED|95.0|-0.89|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 24||2.04|-0.89|0.4409
73978760|NCT02736188|147503271|SUPERIORITY||difference in LS means|0.99||||0.4687|TWO_SIDED|95.0|-1.69|3.68||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.68|-1.69|0.4687
73978761|NCT02736188|147503272|SUPERIORITY||difference in LS means|1.14||||0.1502|TWO_SIDED|95.0|-0.41|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 8||2.69|-0.41|0.1502
73978762|NCT02736188|147503272|SUPERIORITY||difference in LS means|-0.2||||0.8188|TWO_SIDED|-1.89|-1.89|1.49||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.49|-1.89|0.8188
74032708|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-2.5||||||95.0|-6.1|0.6||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.6|-6.1|
73951287|NCT00932646|147435797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.082|0.154|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.154|0.082|<0.0001
73951288|NCT00932646|147435797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.084|0.157|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.157|0.084|<0.0001
73951289|NCT00932646|147435797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.119|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.119|<0.0001
73951290|NCT00653263|147435799|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for the continuous baseline characteristics.For data with 5 time points (baseline and weeks 1 through 4), hypothesis tests were performed to test for a differences between baseline and each subsequent time point as well as differences between each time point For data with 3 time points hypothesis tests were performed to test for a differences between baseline and wk 2, wk 2 and wk 4, as well as between baseline and wk 4.||||<0.05
73951291|NCT00653263|147435800|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.||||<0.05
73978763|NCT02736188|147503272|SUPERIORITY||difference in LS means|0.8||||0.5122|TWO_SIDED|95.0|-1.58|3.17||Baseline is fit into the model as a covariate.|GEE model|||Week 24||3.17|-1.58|0.5122
73978764|NCT02736188|147503272|SUPERIORITY||difference in LS means|0.72||||0.7022|TWO_SIDED|95.0|-2.96|4.4||Baseline is fit into the model as a covariate.|GEE model|||Week 48||4.40|-2.96|0.7022
73978765|NCT02736188|147503273|SUPERIORITY||difference in LS means|0.19||||0.7906|TWO_SIDED|95.0|-1.22|1.6||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.60|-1.22|0.7906
73978766|NCT02736188|147503273|SUPERIORITY||difference in LS means|0.66||||0.3531|TWO_SIDED|95.0|-0.74|2.07||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.07|-0.74|0.3531
73978767|NCT02736188|147503273|SUPERIORITY||difference in LS means|0.15||||0.8846|TWO_SIDED|95.0|-1.92|2.23||Baseline is fit into the model as a covariate.|GEE model|||Week 24||2.23|-1.92|0.8846
73978768|NCT02736188|147503273|SUPERIORITY||difference in LS means|2.08||||0.0168|TWO_SIDED|95.0|0.38|3.79||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.79|0.38|0.0168
73978769|NCT00910962|147503305|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.411|TWO_SIDED|95.0|0.46|1.38|||Cox' proportional hazards model|||||1.38|0.46|0.4110
73978770|NCT00910962|147503305|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9318|TWO_SIDED|95.0|0.6|1.74|||Cox' proportional hazards model|||||1.74|0.60|0.9318
73978771|NCT00910962|147503305|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6805|TWO_SIDED|95.0|0.56|1.46|||Cox' proportional hazards model|||||1.46|0.56|0.6805
73978772|NCT00910962|147503306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.299|TWO_SIDED|95.0|0.39|1.34|||Cox' proportional hazards model|||||1.34|0.39|0.2990
73978773|NCT00910962|147503306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.8235|TWO_SIDED|95.0|0.6|1.9|||Cox' proportional hazards model|||||1.90|0.60|0.8235
73978774|NCT00910962|147503306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.659|TWO_SIDED|95.0|0.52|1.51|||Cox' proportional hazards model|||||1.51|0.52|0.6590
73978775|NCT00910962|147503312|SUPERIORITY||test to reference ratio|0.8||||0.151|TWO_SIDED|95.0|0.59|1.09|||Repeated measures ANCOVA|||||1.09|0.59|0.151
73978776|NCT00910962|147503312|SUPERIORITY||test to reference ratio|0.95||||0.744|TWO_SIDED|95.0|0.7|1.29|||Repeated measures ANCOVA|||||1.29|0.70|0.744
73978777|NCT00910962|147503312|SUPERIORITY||test to treatment ratio|0.87||||0.317|TWO_SIDED|95.0|0.66|1.14|||Repeated measures ANCOVA|||||1.14|0.66|0.317
73978778|NCT00910962|147503313|SUPERIORITY||test to reference ratio|1.03||||0.83|TWO_SIDED|95.0|0.8|1.32|||ANCOVA|||||1.32|0.80|0.83
73978779|NCT00910962|147503313|SUPERIORITY||test to reference ratio|1.08||||0.56|TWO_SIDED|95.0|0.84|1.39|||ANCOVA|||||1.39|0.84|0.56
73978780|NCT00910962|147503313|SUPERIORITY||test to reference ratio|1.05||||0.65|TWO_SIDED|95.0|0.84|1.32|||ANCOVA|||||1.32|0.84|0.65
73978781|NCT00910962|147503314|SUPERIORITY||Test to reference ratio|0.77||||0.04|TWO_SIDED|95.0|0.6|0.99|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours||0.99|0.60|0.040
73978782|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.66||||0.001|TWO_SIDED|95.0|0.52|0.85|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours||0.85|0.52|0.001
73978783|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.71||||0.003|TWO_SIDED|95.0|0.57|0.89|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours||0.89|0.57|0.003
73978784|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.4|0.78|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 48 hours||0.78|0.40|<0.001
73978785|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.33|0.65|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 48 hours||0.65|0.33|<0.001
73978786|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.51|||<|0.001|TWO_SIDED|95.0|0.38|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 48 hours||0.69|0.38|<0.001
73978787|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.68||||0.059|TWO_SIDED|95.0|0.45|1.01|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours||1.01|0.45|0.059
73978788|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.6||||0.013|TWO_SIDED|95.0|0.4|0.9|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours||0.90|0.40|0.013
73978789|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.64||||0.015|TWO_SIDED|95.0|0.45|0.92|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours||0.92|0.45|0.015
73978790|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.7||||0.073|TWO_SIDED|95.0|0.48|1.03|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2||1.03|0.48|0.073
73978791|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.7||||0.075|TWO_SIDED|95.0|0.48|1.04|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2||1.04|0.48|0.075
73978792|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.7||||0.044|TWO_SIDED|95.0|0.5|0.99|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2||0.99|0.50|0.044
73978793|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.78||||0.157|TWO_SIDED|95.0|0.55|1.1|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 4||1.10|0.55|0.157
73978794|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.9||||0.548|TWO_SIDED|95.0|0.63|1.28|||ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 4||1.28|0.63|0.548
73978795|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.83||||0.253|TWO_SIDED|95.0|0.61|1.14|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 4||1.14|0.61|0.253
73978796|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.8||||0.204|TWO_SIDED|95.0|0.58|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 8||1.13|0.58|0.204
73978797|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.99||||0.965|TWO_SIDED|95.0|0.71|1.39|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 8||1.39|0.71|0.965
73978798|NCT00910962|147503314|SUPERIORITY||test to reference ratio|0.89||||0.457|TWO_SIDED|95.0|0.66|1.2|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 8||1.20|0.66|0.457
73978799|NCT00910962|147503314|SUPERIORITY||test to reference ratio|1.58||||0.008|TWO_SIDED|95.0|1.13|2.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 14||2.22|1.13|0.008
73978800|NCT00910962|147503314|SUPERIORITY||test to reference ratio|1.69||||0.002|TWO_SIDED|95.0|1.21|2.38|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 14||2.38|1.21|0.002
73978801|NCT00910962|147503314|SUPERIORITY||test to reference ratio|1.64||||0.001|TWO_SIDED|95.0|1.21|2.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 14||2.21|1.21|0.001
73978802|NCT00910962|147503315|SUPERIORITY||test to reference ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.43|0.69|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours||0.69|0.43|<0.001
73978803|NCT00910962|147503315|SUPERIORITY||test to reference ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.5|0.82|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours||0.82|0.50|<0.001
73978804|NCT00910962|147503315|SUPERIORITY||test to reference ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.48|0.73|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours||0.73|0.48|<0.001
73978805|NCT00910962|147503315|SUPERIORITY||test to reference ratio|0.76||||0.031|TWO_SIDED|95.0|0.59|0.98|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2||0.98|0.59|0.031
73871568|NCT03857542|147286410|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|1.5|3.7||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||3.7|1.5|<.0001
73871569|NCT03857542|147286411|SUPERIORITY||Percentage Difference|12.4||||0.0141|TWO_SIDED|95.0|5.2|19.5||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals was calculated based on normal approximation based on pooled variance without continuity correction.|||19.5|5.2|0.0141
74032709|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-6.3||||||95.0|-12.1|-0.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.7|-12.1|
73978806|NCT00910962|147503315|SUPERIORITY||test to reference ratio|0.88||||0.315|TWO_SIDED|95.0|0.68|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2||1.13|0.68|0.315
73978807|NCT00910962|147503315|SUPERIORITY||test to reference ratio|0.82||||0.075|TWO_SIDED|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2||1.02|0.65|0.075
74032710|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|3.4||||||95.0|-0.9|7.9||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||7.9|-0.9|
73978808|NCT00910962|147503315|SUPERIORITY||test to reference ratio|0.81||||0.068|TWO_SIDED|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||1.02|0.65|0.068
73978809|NCT00910962|147503315|SUPERIORITY||test to reference ratio|0.97||||0.824|TWO_SIDED|95.0|0.78|1.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||1.22|0.78|0.824
73978810|NCT00910962|147503315|SUPERIORITY||test to reference ratio|0.89||||0.246|TWO_SIDED|95.0|0.73|1.09|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||1.09|0.73|0.246
73978811|NCT00910962|147503316|SUPERIORITY||test to reference ratio|1.04||||0.66|TWO_SIDED|95.0|0.89|1.21|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours||1.21|0.89|0.66
73978812|NCT00910962|147503316|SUPERIORITY||test to reference ratio|1.07||||0.39|TWO_SIDED|95.0|0.92|1.25|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours||1.25|0.92|0.39
73871570|NCT03857542|147286412|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|0.5|1.0||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.0|0.5|<.0001
73978813|NCT00910962|147503316|SUPERIORITY||test to reference ratio|1.05||||0.47|TWO_SIDED|95.0|0.92|1.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours||1.21|0.92|0.47
73978814|NCT00910962|147503317|SUPERIORITY||test to reference ratio|0.99||||0.92|TWO_SIDED|95.0|0.78|1.25|||Repeated measures ANCOVA|||||1.25|0.78|0.92
73978815|NCT00910962|147503317|SUPERIORITY||test to reference ratio|1.08||||0.52|TWO_SIDED|95.0|0.85|1.36|||Repeated measures ANCOVA|||||1.36|0.85|0.52
73978816|NCT00910962|147503317|SUPERIORITY||test to reference ratio|1.03||||0.76|TWO_SIDED|95.0|0.84|1.27|||Repeated measures ANCOVA|||||1.27|0.84|0.76
73978817|NCT00910962|147503318|SUPERIORITY||test to reference ratio|0.93||||0.57|TWO_SIDED|95.0|0.72|1.2|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For discharge/early withdrawal||1.20|0.72|0.57
73978818|NCT00910962|147503318|SUPERIORITY||test to reference ratio|0.92||||0.52|TWO_SIDED|95.0|0.72|1.18|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For discharge/early withdrawal||1.18|0.72|0.52
73978819|NCT00910962|147503318|SUPERIORITY||test to reference ratio|0.92||||0.5|TWO_SIDED|95.0|0.74|1.16|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For discharge/early withdrawal||1.16|0.74|0.50
73978820|NCT00910962|147503318|SUPERIORITY||test to reference ratio|0.73||||0.03|TWO_SIDED|95.0|0.55|0.96|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||0.96|0.55|0.03
73871571|NCT03857542|147286413|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08||0.0002|TWO_SIDED|95.0|-0.5|-0.2||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.2|-0.5|0.0002
73871572|NCT03857542|147286414|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07||0.0002|TWO_SIDED|95.0|-0.4|-0.2||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.2|-0.4|0.0002
73978821|NCT00910962|147503318|SUPERIORITY||test to reference ratio|0.81||||0.14|TWO_SIDED|95.0|0.61|1.07|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||1.07|0.61|0.14
73978822|NCT00910962|147503318|SUPERIORITY||test to reference ratio|0.76||||0.04|TWO_SIDED|95.0|0.6|0.98|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||0.98|0.60|0.04
73978823|NCT00910962|147503319|SUPERIORITY||Mean Difference (Final Values)|-1.92||||0.254|TWO_SIDED|95.0|-5.25|1.41|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Day 3-5 (visit 1)||1.41|-5.25|0.254
73951292|NCT00653263|147435801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.||||<0.05
73978824|NCT00910962|147503319|SUPERIORITY||Mean Difference (Final Values)|-2.84||||0.106|TWO_SIDED|95.0|-6.29|0.62|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Day 3-5 (visit 1)||0.62|-6.29|0.106
73871573|NCT03058692|147286420|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
73871574|NCT03058692|147286420|OTHER|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.56
73871575|NCT03058692|147286421|OTHER|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.74
73951293|NCT00654940|147435877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.305||||80.0|-1.21|-0.41|||ANCOVA|||Treatment comparison of pregabalin - placebo: mixed effects analysis of covariance model fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect, and baseline was fitted as two covariates.||-0.41|-1.21|
73978825|NCT00910962|147503319|SUPERIORITY||Mean Difference (Final Values)|-2.38||||0.126|TWO_SIDED|95.0|-5.44|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Day 3-5 (visit 1)||0.69|-5.44|0.126
73951294|NCT00654940|147435878|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|2.493||||80.0|-3.82|2.78|||ANCOVA|||Neuropathic Pain Symptom Inventory treatment comparison: Pregabalin - Placebo. Total score was analyzed using a mixed effect analysis of covariance model based on the full analysis set (FAS), accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.||2.78|-3.82|
73978826|NCT00910962|147503319|SUPERIORITY||Mean Difference (Final Values)|-1.91||||0.184|TWO_SIDED|95.0|-4.74|0.92|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||0.92|-4.74|0.184
73978827|NCT00910962|147503319|SUPERIORITY||Mean Difference (Final Values)|-2.47||||0.093|TWO_SIDED|95.0|-5.37|0.43|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||0.43|-5.37|0.093
73978828|NCT00910962|147503319|SUPERIORITY||Mean Difference (Final Values)|-2.19||||0.096|TWO_SIDED|95.0|-4.78|0.4|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||0.40|-4.78|0.096
73978829|NCT00910962|147503320|SUPERIORITY||Mean Difference (Final Values)|4.22||||0.124|TWO_SIDED|95.0|-1.18|9.62|||Repeated measures ANCOVA|||||9.62|-1.18|0.124
73871576|NCT03058692|147286421|OTHER|||||||0.73||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.73
73978830|NCT00910962|147503320|SUPERIORITY||Mean Difference (Final Values)|6.05||||0.029|TWO_SIDED|95.0|0.63|11.47|||Repeated measures ANCOVA|||||11.47|0.63|0.029
73978831|NCT00910962|147503320|SUPERIORITY||Mean Difference (Final Values)|5.14||||0.039|TWO_SIDED|95.0|0.28|10.0|||Repeated measures ANCOVA|||||10.00|0.28|0.039
73978832|NCT00910962|147503321|SUPERIORITY||Mean Difference (Final Values)|-21.53||||0.025|TWO_SIDED|95.0|-40.27|-2.79|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVEDV||-2.79|-40.27|0.025
73951295|NCT00654940|147435879|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29000.0|STANDARD_ERROR_OF_MEAN|17000.0||||80.0|6100.0|51000.0|||ANCOVA|||Difference in least squares means Pregabalin-Placebo. Model of day (8 am to 8 pm) total activity score at end of treatment. Mixed effects analysis of covariance model was fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.||51000|6100|
73978833|NCT00910962|147503321|SUPERIORITY||Mean Difference (Final Values)|-18.65||||0.053|TWO_SIDED|95.0|-37.58|0.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVEDV||0.29|-37.58|0.053
73978834|NCT00910962|147503321|SUPERIORITY||Mean Difference (Final Values)|-20.09||||0.021|TWO_SIDED|95.0|-37.01|-3.18|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVEDV||-3.18|-37.01|0.021
73978835|NCT00910962|147503321|SUPERIORITY||Mean Difference (Final Values)|-15.82||||0.024|TWO_SIDED|95.0|-29.51|-2.14|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVESV||-2.14|-29.51|0.024
73978836|NCT00910962|147503321|SUPERIORITY||Mean Difference (Final Values)|-17.22||||0.016|TWO_SIDED|95.0|-31.14|-3.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVESV||-3.29|-31.14|0.016
73871577|NCT03058692|147286422|OTHER|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.66
73871578|NCT03058692|147286422|OTHER|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.48
73871579|NCT03058692|147286423|OTHER|||||||0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.32
73871580|NCT03058692|147286423|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
73871581|NCT03058692|147286424|OTHER|||||||0.0078||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0078
73871582|NCT03058692|147286424|OTHER|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.94
73871583|NCT03058692|147286425|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
73871584|NCT03058692|147286425|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.5
73871585|NCT03058692|147286426|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
73978837|NCT00910962|147503321|SUPERIORITY||Mean Difference (Final Values)|-16.52||||0.01|TWO_SIDED|95.0|-28.91|-4.13|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVESV||-4.13|-28.91|0.010
73978838|NCT00910962|147503322|SUPERIORITY||Mean Difference (Final Values)|-22.21||||0.109|TWO_SIDED|95.0|-49.51|5.09|||Repeated measures ANCOVA|||||5.09|-49.51|0.109
73978839|NCT00910962|147503322|SUPERIORITY||Mean Difference (Final Values)|-7.13||||0.614|TWO_SIDED|95.0|-35.22|20.96|||Repeated measures ANCOVA|||||20.96|-35.22|0.614
73978840|NCT00910962|147503322|SUPERIORITY||Mean Difference (Final Values)|-14.67||||0.243|TWO_SIDED|95.0|-39.52|10.18|||Repeated measures ANCOVA|||||10.18|-39.52|0.243
73871586|NCT03058692|147286426|OTHER|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
73978841|NCT00910962|147503323|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.023|TWO_SIDED|95.0|-0.44|-0.03|||Repeated measures ANCOVA|||||-0.03|-0.44|0.023
73978842|NCT00910962|147503323|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.021|TWO_SIDED|95.0|-0.45|-0.04|||Repeated measures ANCOVA|||||-0.04|-0.45|0.021
73978843|NCT00910962|147503323|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.011|TWO_SIDED|95.0|-0.42|-0.06|||Repeated measures ANCOVA|||||-0.06|-0.42|0.011
73871587|NCT03058692|147286427|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
73871588|NCT03058692|147286428|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
73871589|NCT03058692|147286428|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.5
73871590|NCT03058692|147286429|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
73871591|NCT03058692|147286429|OTHER|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.74
73871592|NCT03058692|147286430|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
73871593|NCT03058692|147286430|OTHER|||||||0.9||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.90
73871594|NCT03058692|147286431|OTHER|||||||0.87||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.87
73871595|NCT03058692|147286431|OTHER|||||||0.57||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.57
74032711|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.3||||||95.0|-4.1|1.1||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-4.1|
73951296|NCT01755689|147435955|NON_INFERIORITY|The non-inferiority criteria: the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||TWO_SIDED|95.0|0.99|1.43|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenA titers.||1.43|0.99|
73951297|NCT01755689|147435955|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.01|||||TWO_SIDED|95.0|0.84|1.21|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenA titers.||1.21|0.84|
73951298|NCT01755689|147435955|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||TWO_SIDED|95.0|0.93|1.51|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenC titers.||1.51|0.93|
74089396|NCT02697773|147731621|SUPERIORITY||Least Square Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.49|-0.66|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.66|-1.49|<.0001
74089397|NCT02697773|147731621|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.22||0.0024|TWO_SIDED|95.0|-1.12|-0.24|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-1.12|0.0024
73871596|NCT03058692|147286432|OTHER|||||||0.82||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.82
73871597|NCT03058692|147286432|OTHER|||||||0.076||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.076
73871598|NCT03058692|147286433|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
73951299|NCT01755689|147435955|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.83|||||TWO_SIDED|95.0|0.66|1.06|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenC titers.||1.06|0.66|
73951300|NCT01755689|147435955|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.26|||||TWO_SIDED|95.0|0.97|1.64|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenW-135 titers.||1.64|0.97|
74032712|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|1.7||||||95.0|-3.0|6.4||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.4|-3.0|
74032713|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-5.8|6.7||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.7|-5.8|
74032714|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8||||||95.0|-3.2|1.2||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-3.2|
74032715|NCT00366548|147618465|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.3||||||95.0|-3.6|0.3||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.3|-3.6|
74032716|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.||1.9|-2.1|
73951301|NCT01755689|147435955|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.82|||||TWO_SIDED|95.0|0.63|1.07|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenW-135 titers.||1.07|0.63|
73951302|NCT01755689|147435955|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.05|||||TWO_SIDED|95.0|0.89|1.24|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenY titers.||1.24|0.89|
73951303|NCT01755689|147435955|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.12|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenY titers.||1.12|0.80|
73951304|NCT01755689|147435956|NON_INFERIORITY|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.81|1.15|||ANCOVA|||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-16 titers.||1.15|0.81|
73951305|NCT01755689|147435956|NON_INFERIORITY|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.09|||||TWO_SIDED|95.0|0.92|1.29|||ANCOVA|||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-18 titers.||1.29|0.92|
73951306|NCT01755689|147435956|NON_INFERIORITY|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.2|||||TWO_SIDED|95.0|1.01|1.43|||ANCOVA|||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-16 titers.||1.43|1.01|
73951307|NCT01755689|147435956|NON_INFERIORITY|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.19|||||TWO_SIDED|95.0|1.0|1.41|||ANCOVA|||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-18 titers.||1.41|1.00|
73951308|NCT01755689|147435957|NON_INFERIORITY|For anti-D the lower limit (LL) of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-2.88|||||TWO_SIDED|95.0|-6.9|0.81||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-D titers.||0.81|-6.90|
73951309|NCT01755689|147435957|NON_INFERIORITY|For anti-T the LL of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-0.4|||||TWO_SIDED|95.0|-2.23|1.08||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-T titers.||1.08|-2.23|
73978844|NCT00910962|147503324|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.137|TWO_SIDED|95.0|-0.26|0.04|||Repeated measures ANCOVA|||||0.04|-0.26|0.137
73978845|NCT00910962|147503324|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.036|TWO_SIDED|95.0|-0.32|-0.01|||Repeated measures ANCOVA|||||-0.01|-0.32|0.036
73978846|NCT00910962|147503324|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.047|TWO_SIDED|95.0|-0.28|0.0|||Repeated measures ANCOVA|||||-0.00|-0.28|0.047
73978847|NCT02095678|147503333|OTHER|Significance (alpha) set to 0.05||||||0.211|||||||t-test, 2 sided|||||||0.211
73978848|NCT02095678|147503336|OTHER|Significance (alpha) set to 0.05|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73978849|NCT02095678|147503337|OTHER|Significance (alpha) set to 0.05|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73978850|NCT02334215|147503378|SUPERIORITY|||||||0.32|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usual||||.32
73978851|NCT02334215|147503378|SUPERIORITY|||||||0.32|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.32
73978852|NCT02334215|147503379|SUPERIORITY|||||||0.001|||||||Generalized Linear Mixed Model Analysis|||Contrast of Interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usual Conditions||||.001
73951310|NCT01755689|147435958|NON_INFERIORITY|For anti-PRN the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.53|||||TWO_SIDED|95.0|1.25|1.87|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix+Boostrix Group versus Boostrix+ Cervarix Group in terms of anti-PRN titers.||1.87|1.25|
73951311|NCT01755689|147435958|NON_INFERIORITY|For anti-FHA the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.65|||||TWO_SIDED|95.0|1.42|1.93|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-FHA titers.||1.93|1.42|
73951312|NCT01755689|147435958|NON_INFERIORITY|For anti-PT the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-PT titers.||1.61|1.20|
73951313|NCT01567163|147435978|SUPERIORITY_OR_OTHER||Ratio geometric least squares (LS) means|0.97|||||TWO_SIDED|90.0|0.84|1.1|||Mixed Models Analysis||The ratio of geometric LS means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of geometric LS means is AUC(0-∞) of Cycle 2/Cycle 1.|||1.10|0.84|
73951314|NCT01567163|147435980|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.14|||||TWO_SIDED|90.0|0.84|1.55|||Mixed Models Analysis||The ratio of geometric least squares means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.|||1.55|0.84|
73951315|NCT03405662|147435984|SUPERIORITY|||||||0.07|||||||non-parametric Kolmogorov-Smirnov test|||||||0.07
73978853|NCT02334215|147503379|SUPERIORITY|||||||0.84|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usual||||.84
73978854|NCT02334215|147503380|SUPERIORITY|||||||0.11|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usual||||0.11
73978855|NCT02334215|147503380|SUPERIORITY|||||||0.55|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.55
73978856|NCT02334215|147503381|SUPERIORITY|||||||0.55|||||||Regression, Logistic|||||||0.55
73978857|NCT02334215|147503381|SUPERIORITY|||||||0.57|||||||Regression, Logistic|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.57
73871599|NCT03058692|147286433|OTHER|||||||0.75||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.75
73871600|NCT03058692|147286434|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
73871601|NCT03058692|147286434|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
73871602|NCT03058692|147286435|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>.99
73871603|NCT03058692|147286435|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>.99
73871604|NCT03058692|147286436|OTHER|||||||0.81||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.81
73871605|NCT03058692|147286436|OTHER|||||||0.47||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.47
73871606|NCT03058692|147286437|OTHER|||||||0.0061||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0061
73951316|NCT03405662|147435985|SUPERIORITY|||||||0.29|||||||non-parametric Kolmogorov-Smirnov test|||||||0.29
73951317|NCT03405662|147435986|SUPERIORITY|||||||0.07|||||||non-parametric Kolmogorov-Smirnov test|||||||0.07
73951318|NCT03405662|147435987|SUPERIORITY|||||||0.23|||||||non-parametric Kolmogorov-Smirnov test|||||||0.23
73951319|NCT03405662|147435988|SUPERIORITY|||||||0.68|||||||non-parametric Kolmogorov-Smirnov test|||||||0.68
73951320|NCT03405662|147435989|SUPERIORITY|||||||0.13|||||||non-parametric Kolmogorov-Smirnov test|||||||0.13
73951321|NCT03405662|147435990|SUPERIORITY|||||||0.32|||||||non-parametric Kolmogorov-Smirnov test|||||||0.32
73951322|NCT03405662|147435991|SUPERIORITY|||||||0.68|||||||non-parametric Kolmogorov-Smirnov test|||||||0.68
73951323|NCT03405662|147435992|SUPERIORITY|||||||0.86|||||||non-parametric Kolmogorov-Smirnov test|||||||0.86
73951324|NCT03405662|147435993|SUPERIORITY|||||||0.32|||||||non-parametric Kolmogorov-Smirnov test|||||||0.32
73951325|NCT01177813|147435994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.9|-0.57||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate||-0.57|-0.90|<0.0001
73951326|NCT01177813|147435994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-1.01|-0.69||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate||-0.69|-1.01|<0.0001
73871607|NCT03058692|147286437|OTHER|||||||0.28||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.28
73871608|NCT03058692|147286438|OTHER|||||||0.36||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.36
73951327|NCT01177813|147435995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.48|-1.38||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate||-1.38|-2.48|<0.0001
73978858|NCT02334215|147503382|SUPERIORITY|||||||0.997|||||||Generalized Linear Mixed Model|||Contrast of interest: Methadone plus Patient Navigation and Methadone compared to Enhanced Treatment as Usual||||.997
73978859|NCT02334215|147503382|SUPERIORITY|||||||0.26|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.26
74032717|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-1.7|2.6||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.||2.6|-1.7|
73951328|NCT01177813|147435995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.7|-1.6||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate||-1.60|-2.70|<0.0001
73951329|NCT01177813|147435996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.1||0.0231|TWO_SIDED|97.5|-5.2|0.0||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for Systolic Blood Pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"||0.0|-5.2|0.0231
73951330|NCT01177813|147435996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0028|TWO_SIDED|97.5|-6.0|-0.9||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for Systolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"||-0.9|-6.0|0.0028
73951331|NCT01177813|147435996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.3987|TWO_SIDED|97.5|-2.1|0.9||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"||0.9|-2.1|0.3987
73978860|NCT02334215|147503383|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone compared to Enhanced Treatment as Usual||||||0.663|||||||Generalized Linear Mixed Model|||||||.663
74032718|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-2.4|
74032719|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.9|-2.1|
73951332|NCT01177813|147435996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.0296|TWO_SIDED|97.5|-3.0|0.0||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"||0.0|-3.0|0.0296
73951333|NCT00581256|147435998|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||A Perfusion Defect (PD) increase of greater than 5% for a 2.5 SD threshold was considered significant.||||0.6
73951334|NCT00581256|147435998|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||A PD increase of greater than 10% for a 1.5 SD threshold was considered significant.||||0.46
73951335|NCT01196104|147436006|NON_INFERIORITY_OR_EQUIVALENCE|Study terminated early due to business reasons, results are not properly powered.|Mean Difference (Final Values)|-0.0473|STANDARD_ERROR_OF_MEAN|0.2158||0.8283|TWO_SIDED|95.0|-0.4901|0.3956|||ANCOVA|||ANCOVA model with terms of treatment as a fixed effect and baseline HbA1c as covariate||0.3956|-0.4901|0.8283
73978861|NCT02334215|147503383|SUPERIORITY|||||||0.33|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.33
73978862|NCT02334215|147503384|SUPERIORITY|||||||0.007|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usual||||0.007
73978863|NCT02334215|147503384|SUPERIORITY|||||||0.76|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.76
73978864|NCT02334215|147503385|SUPERIORITY|||||||0.6|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usual||||0.60
74032720|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-1.2|2.3||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.3|-1.2|
74032721|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.0|2.9||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.9|-2.0|
74032722|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.9||||||95.0|-3.4|1.1||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-3.4|
74032723|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.8||||||95.0|-0.8|3.0||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.0|-0.8|
74032724|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.6||||||95.0|-3.7|4.9||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.9|-3.7|
74032725|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-2.4|
74032726|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-2.4|
74032727|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.6|-1.7|
73871609|NCT03058692|147286438|OTHER|||||||0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.32
74032728|NCT00366548|147618466|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.6|-1.7|
74032729|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.81|
74032730|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.9||||||95.0|0.72|1.14||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.72|
74032731|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.85|1.1||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.85|
74032732|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.79|1.15||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.79|
74032733|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.98||||||95.0|0.86|1.13||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.86|
74032734|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.72|0.97||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||0.97|0.72|
74032735|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.71|0.98||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||0.98|0.71|
74032736|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.94||||||95.0|0.81|1.1||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.81|
74032737|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.93||||||95.0|0.83|1.04||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated||1.04|0.83|
74032738|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.83|1.13||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.83|
74032739|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.81|
73871610|NCT03058692|147286439|OTHER|||||||0.42||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.42
73871611|NCT03058692|147286439|OTHER|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.26
73978865|NCT02334215|147503385|SUPERIORITY|||||||1|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||1.0
73978866|NCT02334215|147503386|SUPERIORITY|||||||0.09|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||.09
73978867|NCT02334215|147503386|SUPERIORITY|||||||0.74|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.74
74032740|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|1.05||||||95.0|0.93|1.18||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated||1.18|0.93|
74032741|NCT00366548|147618469|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.91||||||95.0|0.8|1.04||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated||1.04|0.80|
74032742|NCT03463941|147618480|OTHER||||||||||||||||||descriptive|||
74032743|NCT03463941|147618481|OTHER||||||||||||||||||descriptive|||
73871612|NCT03058692|147286440|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
73978868|NCT02334215|147503387|SUPERIORITY|||||||0.013|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||.013
73978869|NCT02334215|147503387|SUPERIORITY|||||||0.71|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.71
73978870|NCT02334215|147503388|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.32|||||||Generalized Linear Mixed Model Analysis|||||||.32
73978871|NCT02334215|147503388|SUPERIORITY|||||||0.85|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.85
73978872|NCT02334215|147503389|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.1|||||||Generalized Linear Mixed Model Analysis|||||||.10
73978873|NCT02334215|147503389|SUPERIORITY|||||||0.74|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.74
73978874|NCT02334215|147503390|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.42|||||||Generalized Linear Mixed Model Analysis|||||||.42
73978875|NCT02334215|147503390|SUPERIORITY|||||||0.42|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.42
74032744|NCT03463941|147618483|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74032745|NCT03463941|147618484|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74032746|NCT03463941|147618485|OTHER||||||||||||||||||descriptive|||
74032747|NCT03463941|147618486|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74032748|NCT03628417|147618506|NON_INFERIORITY|Examined the objective response rate (ORR) that there was 20% difference between the 2 treatment arms at day 180. With a significance level of 0,05 and a power of 80% the study required 28 evaluable metastases.|Odds Ratio (OR)|0.4489629||||0.3|TWO_SIDED|95.0|-13.3|53.3|||Fisher Exact|||After reviewing existing data from electrochemotherapy with intratumoral bleomycin on small cutaneous metastases ≤3cm , we estimated the expected response rate for electrochemotherapy to 85%. We have no clinical results for the treatment of calcium electroporation, but on the basis of preclinical studies, we decided to accept a difference in response of 20%. All statistical analysis were done using IBM SPSS v24.||53.30|-13.30|0.30
74032749|NCT02297438|147618509|SUPERIORITY||Hazard Ratio (HR)|0.677||||0.0012|TWO_SIDED|95.0|0.529|0.867||1-sided p-value from the adjusted log-rank test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral vs. non-visceral) per Randomization.||0.867|0.529|0.0012
74032750|NCT02297438|147618510|SUPERIORITY||Hazard Ratio (HR)|0.861||||0.14778|TWO_SIDED|95.0|0.651|1.139||1-sided p-value from the log-rank test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.139|0.651|0.14778
74032751|NCT02297438|147618511|SUPERIORITY||Odds Ratio (OR)|1.301||||0.154|TWO_SIDED|95.0|0.805|2.1||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.100|0.805|0.154
73951336|NCT00267111|147436040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of \< 0.05 was considered significant.|t-test, 2 sided|||We hypothesized that topical amethocaine gel 4% would reduce the pain from IM injection. The sample size was based on the pain scores obtained from a previous study that compared pain response during IM injection. To achieve a clinically significant reduction in pain scores by 20% between groups with 80% power and an alpha value of \< 0.05, we estimated sample size of 49 neonates in each group. A total of 110 neonates were enrolled to account for possible dropouts and missing data.||||< 0.05
73951337|NCT00267111|147436041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of \< 0.05 was considered significant|t-test, 2 sided|||We hypothesized that parents and nurses will report lower pain scores as assessed by visual analogue scale in topical amethocaine gel 4% compared to placebo group. This was a secondary outcome and no power calculation was performed.||||<0.05
73951338|NCT02368002|147436089|SUPERIORITY|||||||0.25||||||2 df re-random\*time interaction tested if baseline to 6M or 18M PCM and ABT weight changes differed; primary hypothesis tests were 2 planned contrasts estimating baseline to 6M (H1a, expected neg) and 18M (H1b, expected pos) PCM vs. ABT weight change|Mixed Models Analysis|The mixed model included a random participant intercept. Fixed covariates were baseline weight, TRA timing, sex, weight loss rate.||H1 predicted that suboptimal responders re-randomized to PCM would lose more weight at 6m (H1a) while those re-randomized to ABT would lose more weight at 18m (H1b). A mixed linear model predicted weight change from fixed re-randomization, measurement time, the re-randomization by measurement time interaction and covariate parameters.|The primary hypothesis tests were two planned contrasts that estimated weight change from baseline to 6M and 18M relative to baseline in PCM relative to ABT. A mixed linear model predicted weight changes between baseline and post-baseline for suboptimal responders, and this model included two a priori simple effects tests resulting in two mean differences, confidence intervals, and p-values. H1a: -2.7 lbs; 95% CI: -5.8, 0.5; p=0.09. H1b: -1.0 lbs; 95% CI: -4.2, 2.2; p=0.53|||0.25
74032752|NCT02297438|147618512|SUPERIORITY||Odds Ratio (OR)|1.255||||0.206|TWO_SIDED|95.0|0.762|2.066||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.066|0.762|0.206
73951339|NCT02368002|147436090|SUPERIORITY||Mean Difference (Net)|-0.1||||0.96|TWO_SIDED|95.0|-2.4|2.3|||Mixed Models Analysis|The mixed model included a random participant intercept. Fixed covariates were baseline weight, sex, TRA result (PCM, ABT, responder, pre-TRA quit).||Hypothesis 2 predicted that among all participants, those randomized to Early TRA would lose more weight at 6 and 18 months than those randomized to Late TRA. A mixed linear model predicted weight change from fixed treatment response assessment timing and covariate parameters.||2.3|-2.4|0.96
73951340|NCT01183650|147436122|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.05|||||TWO_SIDED|90.0|0.84|1.32|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.32|0.84|
73951341|NCT01183650|147436122|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.8|||||TWO_SIDED|90.0|0.64|1.0|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.00|0.64|
73951342|NCT01183650|147436122|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.31|||||TWO_SIDED|90.0|1.05|1.64|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.64|1.05|
73951343|NCT01183650|147436122|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.99|||||TWO_SIDED|90.0|0.79|1.24|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.24|0.79|
73951344|NCT01183650|147436123|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.98|||||TWO_SIDED|90.0|0.81|1.18|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means(Japanese/Caucasian)|||1.18|0.81|
73978876|NCT02334215|147503391|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.28|||||||Generalized Linear Mixed Model Analysis|||||||.28
73951345|NCT01183650|147436123|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.81|||||TWO_SIDED|90.0|0.67|0.97|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||0.97|0.67|
73978877|NCT02334215|147503391|SUPERIORITY|||||||0.44|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.44
73951346|NCT01183650|147436123|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|1.33|||||TWO_SIDED|90.0|1.07|1.67|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.67|1.07|
73951347|NCT01183650|147436123|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.03|||||TWO_SIDED|90.0|0.83|1.29|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.29|0.83|
73951348|NCT01183650|147436124|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||||95.0|||||Wilcoxon (Mann-Whitney)|Tadalafil Median Difference (Day 1 - Day 10) in Japanese Participants||||||
73951349|NCT01183650|147436124|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||||95.0|||||Wilcoxon (Mann-Whitney)|Tadalafil Median Difference (Day 1 - Day 10) in Caucasian Participants||||||
73951350|NCT01183650|147436124|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|19.83||||||95.0|||||Wilcoxon (Mann-Whitney)|Metabolite IC710 Median Difference (Day 1 - Day 10) in Japanese participants||||||
73951351|NCT01183650|147436124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.02||||||95.0|||||Wilcoxon (Mann-Whitney)|Metabolite IC710 Median Difference (Day 1 - Day 10) in Caucasian participants||||||
73978878|NCT02334215|147503392|SUPERIORITY|||||||0.61|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone combined vs. Enhanced Treatment as Usual||||.61
73978879|NCT02334215|147503392|SUPERIORITY|||||||0.72|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.72
74032753|NCT02297438|147618513|SUPERIORITY||Odds Ratio (OR)|1.315||||0.135|TWO_SIDED|95.0|0.825|2.095||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.095|0.825|0.135
74032754|NCT02297438|147618514|SUPERIORITY||Odds Ratio (OR)|1.392||||0.117|TWO_SIDED|95.0|0.825|2.346||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.346|0.825|0.117
73978880|NCT02334215|147503393|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.71|||||||Generalized Linear Mixed Model Analysis|||||||.71
73978881|NCT02334215|147503393|SUPERIORITY|||||||0.86|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.86
73978882|NCT06943638|147503404|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73978883|NCT03769090|147503425|SUPERIORITY||Hazard Ratio (HR)|0.733|||<|0.001|TWO_SIDED|95.0|0.611|0.879|||Regression, Cox|||H0 = null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDA MDI treatment.||0.879|0.611|<0.001
73978884|NCT03769090|147503425|SUPERIORITY||Hazard Ratio (HR)|0.835||||0.041|TWO_SIDED|95.0|0.702|0.992|||Regression, Cox|||H0 = Null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDI MDI treatment.||0.992|0.702|0.041
73978885|NCT03769090|147503426|SUPERIORITY||Rate Ratio|0.76||||0.008|TWO_SIDED|95.0|0.62|0.93|||Negative binomial model|||Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||0.93|0.62|0.008
73978886|NCT03769090|147503426|SUPERIORITY||Rate Ratio|0.8||||0.028|TWO_SIDED|95.0|0.66|0.98|||Negative binomial model|||Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||0.98|0.66|0.028
73978887|NCT03769090|147503427|SUPERIORITY|||||||0.002|||||||Wilcoxon rank sum|||P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||||0.002
73978888|NCT03769090|147503427|SUPERIORITY|||||||0.06|||||||Wilcoxon rank sum|||P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||||0.06
73978889|NCT03769090|147503428|SUPERIORITY||Odds Ratio (OR)|1.221||||0.033|TWO_SIDED|95.0|1.016|1.467|||Regression, Logistic|||Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.467|1.016|0.033
73978890|NCT03769090|147503428|SUPERIORITY||Odds Ratio (OR)|1.132||||0.175|TWO_SIDED|95.0|0.946|1.353|||Regression, Logistic|||Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.353|0.946|0.175
74032755|NCT02297438|147618517|SUPERIORITY||Odds Ratio (OR)|0.945||||0.471|TWO_SIDED|95.0|0.533|1.673||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.673|0.533|0.471
73978891|NCT03769090|147503429|SUPERIORITY||Odds Ratio (OR)|1.228||||0.028|TWO_SIDED|95.0|1.022|1.475|||Regression, Logistic|||Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.475|1.022|0.028
73978892|NCT03769090|147503429|SUPERIORITY||Odds Ratio (OR)|1.111||||0.26|TWO_SIDED|95.0|0.925|1.335|||Regression, Logistic|||Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.335|0.925|0.26
73978893|NCT01523392|147503462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.6|STANDARD_ERROR_OF_MEAN|14.68|<|0.001|TWO_SIDED|95.0|-213.9|-153.3||Model contained treatment group, period, and sequence as fixed effects and a random effect for patient within sequence|Mixed Models Analysis||Ticagrelor minus clopidogrel|||-153.3|-213.9|<0.001
73978894|NCT01523392|147503463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-103.8|STANDARD_ERROR_OF_MEAN|18.79|<|0.001|TWO_SIDED|95.0|-142.5|-65.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 0.5 hours after loading dose||-65.0|-142.5|<0.001
74032756|NCT02297438|147618518|SUPERIORITY||Odds Ratio (OR)|0.878||||0.383|TWO_SIDED|95.0|0.474|1.621||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.621|0.474|0.383
74032757|NCT02297438|147618519|SUPERIORITY||Odds Ratio (OR)|1.227||||0.248|TWO_SIDED|95.0|0.725|2.082||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.082|0.725|0.248
74032758|NCT02297438|147618520|SUPERIORITY||Odds Ratio (OR)|1.349||||0.189|TWO_SIDED|95.0|0.731|2.509||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.509|0.731|0.189
74032759|NCT02297438|147618521|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.36502|TWO_SIDED|95.0|0.698|1.286||1-sided p-value was from exact test.|Log Rank||Assuming Cox proportional hazards, hazard ratio less than 1 indicates reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.286|0.698|0.36502
74032760|NCT02297438|147618528|SUPERIORITY||Mean|0.031||||0.1914|TWO_SIDED|95.0|-0.02|0.08|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.08|-0.02|0.1914
74032761|NCT02297438|147618529|SUPERIORITY||Mean|3.358||||0.0078|TWO_SIDED|95.0|0.88|5.83|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||5.83|0.88|0.0078
74032762|NCT02297438|147618530|SUPERIORITY||Mean|0.476||||0.7862|TWO_SIDED|95.0|-2.97|3.92|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||3.92|-2.97|0.7862
74032763|NCT02713230|147618533|SUPERIORITY||LSMD|-117.688|||<|0.0001|TWO_SIDED|95.0|-150.896|-84.48|||ANOVA|||||-84.480|-150.896|<0.0001
74032764|NCT02713230|147618534|SUPERIORITY||LSM treatment ratio|0.22|||<|0.0001|TWO_SIDED|95.0|0.131|0.371|||ANOVA|||||0.371|0.131|<0.0001
74032765|NCT02713230|147618535|SUPERIORITY||Treatment difference|0.116||||0.008|TWO_SIDED|95.0|0.032|0.2|||Cochran-Mantel-Haenszel|||||0.200|0.032|0.008
74032766|NCT02713230|147618536|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
74032767|NCT02042404|147618541|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
74032768|NCT02042404|147618542|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
74032769|NCT02042404|147618543|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
74032770|NCT02042404|147618544|SUPERIORITY_OR_OTHER|||||||0.0281|TWO_SIDED||||||repeated measures ANOVA|||||||0.0281
74032771|NCT01623531|147618546|SUPERIORITY||Mann-Whitney U test|386.0|STANDARD_ERROR_OF_MEAN|47.5||0.908|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The distributions of cumulative transfusion units did not differ significantly between patients receiving either RiaSTAP (median = 0, IQR = 0-1) or Placebo (median = 0, IQR = 0.1), U = 386, SE = 47.60, p = .908.|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the data were not normally distributed, and primary outcomes were zero inflated. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug.||||.908
74032772|NCT01623531|147618547|SUPERIORITY||Mean Difference (Net)|-0.498|STANDARD_ERROR_OF_MEAN|0.239||0.047|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.047
74032773|NCT01623531|147618548|SUPERIORITY||Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.0116||0.729|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.729
74032774|NCT01623531|147618549|SUPERIORITY||Mean Difference (Net)|-0.321|STANDARD_ERROR_OF_MEAN|3.699||0.93|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.93
74032775|NCT01623531|147618550|SUPERIORITY||Mean Difference (Net)|-11.821|STANDARD_ERROR_OF_MEAN|8.471||0.169|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|||||.169
74032776|NCT01623531|147618551|SUPERIORITY||Mann-Whitney U test|450.5|STANDARD_ERROR_OF_MEAN|54.163||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.035
74032777|NCT01623531|147618552|SUPERIORITY||Mann-Whitney U test|337.5|STANDARD_ERROR_OF_MEAN|51.591||0.794|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.794
74032778|NCT01623531|147618553|SUPERIORITY||Mann-Whitney U test|335.5|STANDARD_ERROR_OF_MEAN|52.957||0.828|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.828
73871613|NCT03058692|147286440|OTHER|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.56
73951352|NCT01284140|147436125|OTHER|||||||0.37|||||||Extra sum-of-squares F test|The null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was not rejected for the Usual Care group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Usual Care group.||||0.37
73951353|NCT01284140|147436125|OTHER|||||||0.0074|||||||Extra sum-of-squares F test|This result suggests that the best-fit values for amplitude and phase are different between Day 1 and Day 3 in the Sleep Promotion group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Sleep promotion group.||||0.0074
73951354|NCT01284140|147436126|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
73951355|NCT01284140|147436127|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.03|TWO_SIDED||||||t-test, 2 sided|||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. This resulted in 4 separate best-fit curves. The model parameter of amplitude was derived from the best-fit curves.||||0.03
73951356|NCT03192215|147436142|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.64|1.55|||Log Rank|||||1.55|0.64|0.99
73951357|NCT03192215|147436143|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.72|TWO_SIDED|95.0|0.59|1.44|||Log Rank|||||1.44|0.59|0.72
73951358|NCT03192215|147436144|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.67|TWO_SIDED|95.0|0.76|1.52|||Log Rank|||||1.52|0.76|0.67
73951359|NCT03192215|147436145|SUPERIORITY||Difference of annual rate.|-0.011||||0.02|TWO_SIDED|95.0|-0.018|-0.003|||Exact Binomial Test|||||-0.003|-0.018|.02
73951360|NCT03192215|147436146|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.98|TWO_SIDED|95.0|0.29|3.52|||Log Rank|||||3.52|0.29|0.98
73871614|NCT03058692|147286441|OTHER|||||||0.97||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.97
73951361|NCT03192215|147436147|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.35|TWO_SIDED|95.0|0.63|3.75|||Log Rank|||||3.75|0.63|0.35
73951362|NCT02593032|147436148|SUPERIORITY||Mean Difference (Net)|12.0|||<|0.05|TWO_SIDED|||||This is the calculated p-value, not a threshold.|t-test, 2 sided|||||||<0.05
73951363|NCT05199233|147436149|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|The mean change from baseline was compared to zero using a one-sample t-test.||||||<0.001
73951364|NCT05199233|147436150|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|The mean change from baseline was compared to zero using a one-sample t-test.||||||<0.001
73951365|NCT02144519|147436202|SUPERIORITY||Odds Ratio (OR)|1.88||||0.008|TWO_SIDED|95.0|1.18|3.0|||Mixed Models Analysis|||||3.00|1.18|0.008
73951366|NCT02144519|147436203|SUPERIORITY||Odds Ratio (OR)|3.8||||0.003|TWO_SIDED|95.0|1.45|9.95|||Regression, Logistic|||||9.95|1.45|0.003
73951367|NCT05515679|147436261|SUPERIORITY||Median Difference (Final Values)|0.72|STANDARD_DEVIATION|0.48|<|0.01|TWO_SIDED|95.0|0.51|0.94|||t-test, 2 sided|||Using a paired sample t-test (two tailed), we wished to examine whether there was an increase in Constructive Engagement and Pleasure and a reduction in Passive Engagement, Distracted Engagement, and Non-Engagement, from baseline to treatment. With an anticipated PWD sample of 24, and using means and standard deviations from the PI's previous studies, we calculated a power of 90% to detect effects (alpha = .05; one-tailed test). (3) PWD and staff report high satisfaction wi||.94|.51|<0.01
73951368|NCT05515679|147436262|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|0.6||0.017|TWO_SIDED|95.0|-0.59|-0.07|||t-test, 2 sided|||||-0.07|-0.59|.017
73951369|NCT05515679|147436263|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|0.41||0.008|TWO_SIDED|95.0|-0.43|-0.07|||t-test, 2 sided|||||-0.07|-0.43|.008
73951370|NCT05515679|147436264|SUPERIORITY||Median Difference (Final Values)|-0.15|STANDARD_DEVIATION|0.34||0.053|TWO_SIDED|95.0|-0.3|0.0|||t-test, 2 sided|||||-.00|-.30|0.053
73951371|NCT05515679|147436265|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|0.28|<|0.01|TWO_SIDED|95.0|0.54|0.79|||t-test, 2 sided|||||.79|.54|<.01
73951372|NCT05515679|147436266|SUPERIORITY||Mean Difference (Final Values)|4.11|STANDARD_DEVIATION|3.35|<|0.001|TWO_SIDED|95.0|2.62|5.6|||t-test, 2 sided|||||5.60|2.62|<.001
73951373|NCT05515679|147436267|SUPERIORITY||Mean Difference (Final Values)|-1.07|STANDARD_DEVIATION|1.1|<|0.001|TWO_SIDED|95.0|-1.55|-0.58|||t-test, 2 sided|||||-0.58|-1.55|<.001
73951374|NCT05515679|147436268|SUPERIORITY||Median Difference (Final Values)|6.02|STANDARD_DEVIATION|11.4||0.022|TWO_SIDED|95.0|0.97|11.1|||t-test, 2 sided|||||11.1|0.97|.022
73951375|NCT05515679|147436269|SUPERIORITY||Mean Difference (Final Values)|1.23|STANDARD_DEVIATION|9.5||0.551|TWO_SIDED|95.0|-2.9|5.44|||t-test, 2 sided|||||5.44|-2.90|.551
74032779|NCT01623531|147618554|SUPERIORITY||Mann-Whitney U test|396.0|STANDARD_ERROR_OF_MEAN|60.944||0.941|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.941
74032780|NCT01623531|147618555|SUPERIORITY||Mann-Whitney U test|494.5|STANDARD_ERROR_OF_MEAN|60.783||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.09
74032781|NCT01623531|147618556|SUPERIORITY||Mann-Whitney U test|418.5|STANDARD_ERROR_OF_MEAN|60.93||0.658|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.658
74032782|NCT01623531|147618557|SUPERIORITY||Mann-Whitney U test|472.5|STANDARD_ERROR_OF_MEAN|60.727||0.182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.182
74032783|NCT01623531|147618558|SUPERIORITY||Mann-Whitney U test|428.0|STANDARD_ERROR_OF_MEAN|60.919||0.549|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.549
74032784|NCT01623531|147618559|SUPERIORITY||Mann-Whitney U test|530.5|STANDARD_ERROR_OF_MEAN|60.816||0.022|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The distribution of FIBTEM MCF (maximum clot firmness) was significantly different between RiaSTAP (median = 27 mm, IQR = 24, 30), and placebo (median = 23 mm, IQR = 22, 27) groups, U-test = 530.5, SE = 60.816, p = .022).|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the FIBTEM MCF data was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.022
74032785|NCT01623531|147618560|SUPERIORITY||Mann-Whitney U test|437.0|STANDARD_ERROR_OF_MEAN|60.93||0.455|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.455
73951376|NCT05515679|147436270|SUPERIORITY||Mean Difference (Final Values)|27.43|STANDARD_DEVIATION|0.11|<|0.001|TWO_SIDED|95.0|17.7|37.2|||t-test, 2 sided|||||37.2|17.7|<.001
73951377|NCT04230980|147436294|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.01|TWO_SIDED|95.0|-2.02|-0.24|||t-test, 2 sided||Direction of mean difference is Gabapentin arm minus placebo arm.|Mean NRS-11 score at post-operative day 7 (compared between the two arms).||-0.24|-2.02|0.01
74032786|NCT01623531|147618561|SUPERIORITY||Mann-Whitney U test|432.5|STANDARD_ERROR_OF_MEAN|60.819||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.5
74032787|NCT01623531|147618562|SUPERIORITY|||||||1|||||||Fisher Exact|Significance (2-sided) using Fisher's Exact Test.||||||1.0
74032788|NCT01617681|147618574|OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|2.96||0.0096|TWO_SIDED|95.0|-13.86|-2.01|||ANCOVA|||||-2.01|-13.86|0.0096
74032789|NCT01617681|147618574|OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|2.07||0.6531|TWO_SIDED|95.0|-5.07|3.2|||ANCOVA|||||3.20|-5.07|0.6531
74032790|NCT01617681|147618575|OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|2.54||0.003|TWO_SIDED|95.0|-12.94|-2.78|||ANCOVA|||||-2.78|-12.94|0.0030
74032791|NCT01617681|147618575|OTHER||Mean Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|1.8||0.0042|TWO_SIDED|95.0|-8.98|-1.77|||ANCOVA|||||-1.77|-8.98|0.0042
74032792|NCT01617681|147618576|OTHER||Odds Ratio (OR)|1.68||||0.411|TWO_SIDED|95.0|0.49|5.8|||ANCOVA|||||5.8|0.49|0.411
74032793|NCT01617681|147618576|OTHER||Odds Ratio (OR)|1.45||||0.5443|TWO_SIDED|95.0|0.44|4.79|||ANCOVA|||||4.79|0.44|0.5443
74032794|NCT01617681|147618577|OTHER||Odds Ratio (OR)|0.517||||0.2624|TWO_SIDED|95.0|0.16|1.64|||ANCOVA|||||1.64|0.16|0.2624
74032795|NCT01883440|147618592|SUPERIORITY_OR_OTHER||||||<|0.037|TWO_SIDED||||||Mixed Models Analysis|Linear mixed model||||||<0.037
74032796|NCT01883440|147618593|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Mixed Models Analysis|||In the material when all were included, there were a lot of persons with few symptoms in both Groups, which means that a larger study would be needed in order to detect significant differences.||||0.381
74032797|NCT03696758|147618594|OTHER|Descriptive statistics||||||0.004||||||p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.004
74032798|NCT03696758|147618595|OTHER|Descriptive statistics||||||0.13||||||P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.13
74032799|NCT03696758|147618596|OTHER|descriptive statistics||||||0.004||||||p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.004
74032800|NCT03696758|147618597|OTHER|Descriptive statistics||||||0.1||||||p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.1
74032801|NCT03696758|147618598|OTHER|Descriptive statistics||||||0.09||||||p value is 0.09 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.09
74032802|NCT03696758|147618599|OTHER|Descriptive statistics||||||0.1||||||p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.10
74032803|NCT03696758|147618600|OTHER|Descriptive statistics||||||0.82||||||p value is 0.82 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.82
73951378|NCT04230980|147436295|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.19|TWO_SIDED|95.0|-0.13|0.03|||t-test, 2 sided||Direction of mean difference is Gabapentin arm minus placebo arm.|Mean number of opioid tablets taken at post-operative day 7 (compared between the two arms).||0.03|-0.13|0.19
73978895|NCT01523392|147503463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-165.3|STANDARD_ERROR_OF_MEAN|15.45|<|0.001|TWO_SIDED|95.0|-197.4|-133.3|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours after loading dose||-133.3|-197.4|<0.001
73978896|NCT01523392|147503464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-135.0|STANDARD_ERROR_OF_MEAN|12.35|<|0.001|TWO_SIDED|95.0|-160.4|-109.5|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 2 hours on Day 7 after multiple doses||-109.5|-160.4|<0.001
73951379|NCT01556763|147436311|SUPERIORITY_OR_OTHER||||||=|0.1||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.10
73951380|NCT01556763|147436312|SUPERIORITY_OR_OTHER||||||=|0.07||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.07
73951381|NCT01556763|147436313|SUPERIORITY_OR_OTHER||||||=|0.02||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.02
73951382|NCT01556763|147436314|SUPERIORITY_OR_OTHER||||||=|0.008||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.008
73951383|NCT04793464|147436337|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.26|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.26
73951384|NCT04793464|147436338|SUPERIORITY||Mean Difference (Final Values)|0.87||||0.02|TWO_SIDED||||||ANCOVA|Ratio of Means||Number analyzed is the number of participants with valid baseline and follow-up data.||||.02
74032804|NCT03696758|147618601|OTHER|Descriptive statistics||||||0.3||||||p value is 0.30 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.30
74032805|NCT03696758|147618602|OTHER|Descriptive statistics||||||0.36||||||p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.36
74032806|NCT03696758|147618603|OTHER|Descriptive statistics||||||0.36||||||p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.36
74032807|NCT03696758|147618604|OTHER|Descriptive statistics||||||0.65||||||P-Value is 0.65 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.65
74032808|NCT03696758|147618605|OTHER|Descriptive statistics||||||0.25||||||P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.25
74032809|NCT03696758|147618606|OTHER|Descriptive statistics||||||0.43||||||P-Value is 0.43 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.43
74032810|NCT03696758|147618607|OTHER|Descriptive statistics||||||0.66||||||P-Value is 0.66 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.66
74032811|NCT03696758|147618608|OTHER|Descriptive statistics||||||0.13||||||P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.13
74032812|NCT03696758|147618609|OTHER|Descriptive statistics||||||0.57||||||P-Value is 0.57 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.57
74032813|NCT03696758|147618610|OTHER|Descriptive statistics||||||0.25||||||P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.25
74032814|NCT03696758|147618611|OTHER|Descriptive statistics||||||0.07||||||P-Value is 0.07 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.07
74032815|NCT03696758|147618612|OTHER|Descriptive statistics||||||0.36||||||P-Value is 0.36 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.36
74032816|NCT03696758|147618613|OTHER|Descriptive statistics||||||0.91||||||P-Value is 0.91 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.91
74032817|NCT01856595|147618650|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-2.77|STANDARD_ERROR_OF_MEAN|8.532||0.7457|TWO_SIDED|90.0|-16.93|11.38||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||11.38|-16.93|0.7457
73978897|NCT01523392|147503464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-118.1|STANDARD_ERROR_OF_MEAN|12.55|<|0.001|TWO_SIDED|95.0|-143.9|-92.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours on Day 7 after multiple doses||-92.2|-143.9|<0.001
74032818|NCT01856595|147618650|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-21.64|STANDARD_ERROR_OF_MEAN|8.334||0.0108|TWO_SIDED|90.0|-35.47|-7.81||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-7.81|-35.47|0.0108
73871615|NCT03058692|147286441|OTHER|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.62
73951385|NCT04793464|147436339|SUPERIORITY||Odds Ratio (OR)|1.1||||0.68|TWO_SIDED||||||ANCOVA|Logistic regression||Number analyzed is the number of participants with valid baseline and follow-up data.||||.68
73951386|NCT04793464|147436340|SUPERIORITY||Odds Ratio (OR)|1.19||||0.44|TWO_SIDED||||||ANCOVA|Logistic regression||Number analyzed is the number of participants with valid baseline and follow-up data.||||.44
73951387|NCT04793464|147436341|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.77|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.77
73951388|NCT04793464|147436342|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.66|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.66
73951389|NCT04793464|147436343|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.44|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.44
73951390|NCT04793464|147436344|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.017|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||0.017
73951391|NCT03844321|147436372|SUPERIORITY||Difference in Slopes|-0.02||||0.82|TWO_SIDED|95.0|-0.24|0.19||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|df = 1607|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.||0.19|-0.24|.820
73951392|NCT03844321|147436372|SUPERIORITY||Difference in Slopes|-0.08||||0.11|TWO_SIDED|95.0|-0.18|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1147|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.||0.02|-0.18|.110
73951393|NCT03844321|147436373|SUPERIORITY||Difference in Slopes|-0.03||||0.284|TWO_SIDED|95.0|-0.07|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df= 1726|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.02|-0.07|.284
73951394|NCT03844321|147436373|SUPERIORITY||Difference in Slopes|0.01||||0.394|TWO_SIDED|95.0|-0.01|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1018|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|-0.01|.394
73951395|NCT03844321|147436374|SUPERIORITY||Difference in Slopes|0.03||||0.431|TWO_SIDED|95.0|-0.04|0.09||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1591|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.09|-0.04|.431
73951396|NCT03844321|147436374|SUPERIORITY||Difference in Slopes|0.05|||<|0.001|TWO_SIDED|95.0|0.02|0.08||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1159|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.08|0.02|<.001
73978898|NCT01523392|147503464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-133.4|STANDARD_ERROR_OF_MEAN|12.77|<|0.001|TWO_SIDED|95.0|-159.7|-107.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at end of dosing interval on Day 8||-107.1|-159.7|<0.001
73871616|NCT03058692|147286442|OTHER|||||||0.15||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.15
73871617|NCT03058692|147286442|OTHER|||||||0.18||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.18
73871618|NCT03058692|147286443|OTHER|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.94
73871619|NCT03058692|147286443|OTHER|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
73871620|NCT03058692|147286444|OTHER|||||||0.14||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.14
73978899|NCT01719172|147503476|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was \> 50%.|t-test, 1 sided|||The primary effectiveness endpoint was the percent (%) success in obtaining hemostasis at the Target Bleeding Site (TBS) within 5 minutes following Veriset™ application. An exact (Clopper-Pearson) 95% confidence interval for the true success percentage was calculated. Subjects who received rescue therapy on the target bleeding site prior to obtaining hemostasis were considered failures.||||<0.0001
73978900|NCT01719172|147503477|SUPERIORITY_OR_OTHER|||||||0.0214||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was \> 50%.|t-test, 1 sided|||The number and percentage of subjects who achieved hemostasis within 1 minute were presented. An exact (Clopper-Pearson) 95% confidence interval for the true percentage was calculated.||||0.0214
73978901|NCT01719172|147503478|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||||ONE_SIDED|95.0||1.0||||||Time to achieve hemostasis was analyzed using the Kaplan-Meier method to estimate the survival distribution and to obtain the estimated median time to hemostasis. Additionally, A 95% Brookmeyer-Crowley confidence interval for the median was computed based on the sign test.||1.0||
73978902|NCT00770874|147503506|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.125|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.125
73978903|NCT00770874|147503507|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.48|0.8|||Log Rank|||||0.80|0.48|<0.001
73978904|NCT01332266|147503534|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.46||||||||1.46|0.54|
73978905|NCT01332266|147503536|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.61|1.73||||||||1.73|0.61|
73978906|NCT01332266|147503537|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.37||||||||1.37|0.53|
73978907|NCT03302091|147503539|OTHER||Adjusted gMean ratio (T/R)%|198.5|STANDARD_DEVIATION|96.5|||TWO_SIDED|90.0|101.83|386.94|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||386.94|101.83|
74032819|NCT01856595|147618650|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-26.59|STANDARD_ERROR_OF_MEAN|8.309||0.0018|TWO_SIDED|90.0|-40.38|-12.8||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-12.80|-40.38|0.0018
74032820|NCT01856595|147618650|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-32.33|STANDARD_ERROR_OF_MEAN|8.038||0.0001|TWO_SIDED|90.0|-45.66|-18.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-18.99|-45.66|0.0001
74032821|NCT01856595|147618650|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-42.39|STANDARD_ERROR_OF_MEAN|8.34|<|0.0001|TWO_SIDED|90.0|-56.23|-28.55||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-28.55|-56.23|<0.0001
73871621|NCT03058692|147286444|OTHER|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.26
73871622|NCT03058692|147286445|OTHER|||||||0.72||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.72
73871623|NCT03058692|147286445|OTHER|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.31
73871624|NCT03058692|147286446|OTHER|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.31
73978908|NCT03302091|147503540|OTHER||Adjusted gMean ratio (T/R)%|198.42|STANDARD_DEVIATION|77.5|||TWO_SIDED|90.0|116.56|337.78|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||337.78|116.56|
73978909|NCT03302091|147503541|OTHER||Adjusted gMean ratio (T/R)%|226.29|STANDARD_DEVIATION|47.5|||TWO_SIDED|90.0|156.35|327.53|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||327.53|156.35|
73978910|NCT03302091|147503542|OTHER||Adjusted gMean ratio (T/R)%|140.4|STANDARD_DEVIATION|32.8|||TWO_SIDED|90.0|108.06|182.43|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||182.43|108.06|
74032822|NCT01856595|147618651|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|10.47|STANDARD_ERROR_OF_MEAN|9.621||0.279|TWO_SIDED|90.0|-5.5|26.43||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||26.43|-5.50|0.2790
74032823|NCT01856595|147618651|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-19.33|STANDARD_ERROR_OF_MEAN|8.777||0.0299||90.0|-33.89|-4.76||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-4.76|-33.89|0.0299
73871625|NCT03058692|147286446|OTHER|||||||0.22||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.22
73871626|NCT03058692|147286447|OTHER|||||||0.16||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.16
73978911|NCT03302091|147503543|OTHER||Adjusted gMean ratio (T/R)%|165.63|STANDARD_DEVIATION|56.6|||TWO_SIDED|90.0|107.51|255.17|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||255.17|107.51|
73978912|NCT03302091|147503544|OTHER||Adjusted gMean ratio (T/R)%|128.44|STANDARD_DEVIATION|31.7|||TWO_SIDED|90.0|99.64|165.57|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||165.57|99.64|
73871627|NCT03058692|147286447|OTHER|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.44
73871628|NCT03058692|147286448|OTHER|||||||0.67||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.67
73978913|NCT01482091|147503693|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
73978914|NCT01482091|147503695|SUPERIORITY_OR_OTHER||||||=|0.05|||||||Fisher Exact|||||||=0.05
73978915|NCT01482091|147503696|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73978916|NCT01482091|147503699|SUPERIORITY_OR_OTHER||||||=|0.68|||||||t-test, 2 sided|||||||=0.68
73978917|NCT01482091|147503700|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73978918|NCT01482091|147503701|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73978919|NCT01482091|147503705|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
73978920|NCT01480258|147503706|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRP ≥ 1.0 μg/mL||||<0.001
73978921|NCT01480258|147503706|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-HBsAg ≥10 mIU/mL||||<0.001
73978922|NCT01480258|147503706|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Diphtheria ≥0.1 IU/mL||||<0.001
73978923|NCT01480258|147503706|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Tetanus ≥0.1 IU/mL||||<0.001
73978924|NCT01480258|147503706|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PT seroresponse||||<0.001
73978925|NCT01480258|147503706|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FHA seroresponse||||<0.001
74032824|NCT01856595|147618652|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-29.43|STANDARD_ERROR_OF_MEAN|7.609||0.0005|TWO_SIDED|90.0|-42.28|-16.57||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-16.57|-42.28|0.0005
73978926|NCT01480258|147503706|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FIM seroresponse||||<0.001
73978927|NCT01480258|147503706|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRN seroresponse||||<0.001
73978928|NCT01480258|147503706|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV1 ≥1:8 dilution||||<0.001
73978929|NCT01480258|147503706|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV2 ≥1:8 dilution||||<0.001
73978930|NCT01480258|147503706|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV3 ≥1:8 dilution||||<0.001
73978931|NCT01480258|147503707|NON_INFERIORITY|If the lower bound of the 95% confidence interval (CI) was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|41.05|51.06||Stratification by country.|Miettinen & Nurminen|||||51.06|41.05|<0.001
73978932|NCT01480258|147503708|SUPERIORITY|If the lower bound of the 95% CI was greater than 0, it was concluded that PR5I group response rate was superior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|41.05|51.06|||Miettinen & Nurminen|Stratification by country.||||51.06|41.05|<0.001
73978933|NCT01480258|147503709|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in PRP response rate (based on Ab titre ≥1.0 μg/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.27|||<|0.001|TWO_SIDED|95.0|-5.13|2.52|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-inferiority for PRP||2.52|-5.13|<0.001
74032825|NCT01856595|147618652|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-11.89|STANDARD_ERROR_OF_MEAN|7.321||0.1133|TWO_SIDED|90.0|-24.26|0.48||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.48|-24.26|0.1133
73871629|NCT03058692|147286448|OTHER|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.48
73871630|NCT03058692|147286449|OTHER||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||<0.001
73871631|NCT03058692|147286449|OTHER|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.62
73871632|NCT03058692|147286450|OTHER|||||||0.0093||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0093
73871633|NCT03058692|147286450|OTHER|||||||0.51||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.51
73871634|NCT03058692|147286451|OTHER|||||||0.54||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.54
73978934|NCT01480258|147503709|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in HBsAg response rate (based on Ab titre ≥10 mIU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|ifference in percentages|-0.59|||<|0.001|TWO_SIDED|95.0|-2.66|1.35|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for HBsAg||1.35|-2.66|<0.001
74032826|NCT01856595|147618653|SUPERIORITY_OR_OTHER||Ratio|0.99|STANDARD_ERROR_OF_MEAN|1.066||0.853|TWO_SIDED|90.0|0.89|1.1||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.10|0.89|0.8530
74032827|NCT01856595|147618653|SUPERIORITY_OR_OTHER||Ratio|0.86|STANDARD_ERROR_OF_MEAN|1.065||0.0172|TWO_SIDED|90.0|0.77|0.95||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.95|0.77|0.0172
74032828|NCT01856595|147618653|SUPERIORITY_OR_OTHER||Ratio|0.85|STANDARD_ERROR_OF_MEAN|1.064||0.0106|TWO_SIDED|90.0|0.77|0.94||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.94|0.77|0.0106
73871635|NCT03058692|147286451|OTHER|||||||0.43||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.43
74032829|NCT01856595|147618653|SUPERIORITY_OR_OTHER||Ratio|0.82|STANDARD_ERROR_OF_MEAN|1.062||0.0012|TWO_SIDED|90.0|0.74|0.9||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.90|0.74|0.0012
73871636|NCT03058692|147286452|OTHER|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.44
73951397|NCT03844321|147436375|SUPERIORITY||Difference in Slopes|-0.01||||0.399|TWO_SIDED|95.0|-0.05|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1601|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.02|-0.05|.399
73951398|NCT03844321|147436375|SUPERIORITY||Difference in Slopes|0.02||||0.048|TWO_SIDED|95.0|0.0|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1171|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|0.00|.048
73951399|NCT03844321|147436376|SUPERIORITY||Difference in Slopes|-0.02||||0.488|TWO_SIDED|95.0|-0.06|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1560|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.03|-0.06|.488
73951400|NCT03844321|147436376|SUPERIORITY||Difference in Slopes|0.01||||0.446|TWO_SIDED|95.0|-0.01|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1179|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|-0.01|.446
73951401|NCT03844321|147436377|SUPERIORITY||Difference in Slopes|-0.04||||0.469|TWO_SIDED|95.0|-0.16|0.07||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1618|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly FFMQ scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.07|-0.16|.469
73951402|NCT03844321|147436377|SUPERIORITY||Difference in Slopes|-0.06||||0.033|TWO_SIDED|95.0|-0.11|-0.01||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1067|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used linear mixed effects models to examine the effect of time on weekly FFMQ scores across both intervention conditions from baseline to 20 weeks.||-0.01|-0.11|.033
73978935|NCT01480258|147503709|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in Diphtheria response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.21|||<|0.001|TWO_SIDED|95.0|-2.54|-0.22|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for Diptheria||-0.22|-2.54|<0.001
74032830|NCT01856595|147618653|SUPERIORITY_OR_OTHER||Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.065|<|0.0001|TWO_SIDED|90.0|0.69|0.85||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.85|0.69|<0.0001
73871637|NCT03058692|147286452|OTHER|||||||0.014||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.014
73871638|NCT03058692|147286453|OTHER||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||<0.001
73871639|NCT03058692|147286453|OTHER|||||||0.96||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.96
73951403|NCT03844321|147436378|SUPERIORITY|||||||0.046||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.046
73951404|NCT03844321|147436378|SUPERIORITY|||||||0.275||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.275
73951405|NCT03844321|147436379|SUPERIORITY|||||||0.977||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.977
73951406|NCT03844321|147436379|SUPERIORITY|||||||0.341||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.341
73951407|NCT03844321|147436380|SUPERIORITY|||||||0.885||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.885
73951408|NCT03844321|147436380|SUPERIORITY|||||||0.319||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.319
73978936|NCT01480258|147503709|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in Tetanus response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|TWO_SIDED|95.0|-0.95|0.5|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for Tetanus||0.50|-0.95|<0.001
74032831|NCT01856595|147618654|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.075||0.7804|TWO_SIDED|90.0|0.87|1.1||Two-sided p-values are from analysis of ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.10|0.87|0.7804
74032832|NCT01856595|147618654|SUPERIORITY_OR_OTHER||Ratio|0.88|STANDARD_ERROR_OF_MEAN|1.068||0.0908|TWO_SIDED|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.00|0.77|0.0908
73951409|NCT03844321|147436381|SUPERIORITY|||||||0.838||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.838
73951410|NCT03844321|147436381|SUPERIORITY|||||||0.89||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.890
74032833|NCT01856595|147618655|SUPERIORITY_OR_OTHER||Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.083||0.0027|TWO_SIDED|90.0|0.68|0.88||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.88|0.68|0.0027
74032834|NCT01856595|147618655|SUPERIORITY_OR_OTHER||Ratio|0.88|STANDARD_ERROR_OF_MEAN|1.079||0.0908|TWO_SIDED|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.00|0.77|0.0908
74032835|NCT01856595|147618659|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.123||0.8723|TWO_SIDED|90.0|0.81|1.19||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.19|0.81|0.8723
73978937|NCT01480258|147503709|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for PT was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.54|||<|0.001|TWO_SIDED|95.0|-1.75|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for PT||0.49|-1.75|<0.001
73978938|NCT01480258|147503709|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for FHA was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.73|||<|0.001|TWO_SIDED|95.0|-3.47|-0.26|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for FHA||-0.26|-3.47|<0.001
73978939|NCT01480258|147503709|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for PRN was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.42|||<|0.001|TWO_SIDED|95.0|-3.42|0.39|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for PRN||0.39|-3.42|<0.001
73978940|NCT01480258|147503709|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV1 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.51|||<|0.001|TWO_SIDED|95.0|-1.59|0.34|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV1||0.34|-1.59|<0.001
73978941|NCT01480258|147503709|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV2 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|TWO_SIDED|95.0|-0.96|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV2||0.49|-0.96|<0.001
73978942|NCT01480258|147503709|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV3 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.16|||<|0.001|TWO_SIDED|95.0|-1.2|0.82|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV3||0.82|-1.20|<0.001
73978943|NCT01480258|147503710|NON_INFERIORITY|The estimate for anti-rotavirus IgA GMT ratio (PR5I group/INFANRIX hexa group) was calculated with its 1-sided P-value and 2-sided 95% CI. If the lower bound of the 95% CI for GMT ratio was greater than 0.50 (non-inferiority margin), it was concluded that the Rotarix antigen response in the PR5I group was not inferior to the Rotarix antigen response in the INFANRIX hexa group.|Geometric Mean Titre (GMT) ratio|0.8||||0.011|TWO_SIDED|95.0|0.54|1.2|||ANCOVA|||||1.20|0.54|0.011
74032836|NCT01856595|147618659|SUPERIORITY_OR_OTHER||Ratio|0.93|STANDARD_ERROR_OF_MEAN|1.124||0.5158|TWO_SIDED|90.0|0.76|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.13|0.76|0.5158
73978944|NCT01480258|147503711|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.7|1.4||||||ISR or systemic AE||1.4|-0.7|
73978945|NCT01480258|147503711|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8||||||95.0|-0.3|2.0||||||ISR or V-related systemic AE||2.0|-0.3|
74032837|NCT01856595|147618659|SUPERIORITY_OR_OTHER||Ratio|0.83|STANDARD_ERROR_OF_MEAN|1.126||0.1258|TWO_SIDED|90.0|0.68|1.01||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.01|0.68|0.1258
74032838|NCT01856595|147618659|SUPERIORITY_OR_OTHER||Ratio|0.89|STANDARD_ERROR_OF_MEAN|1.115||0.2883|TWO_SIDED|90.0|0.74|1.07||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.07|0.74|0.2883
73871640|NCT03058692|147286454|OTHER|||||||0.65||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.65
73871641|NCT03058692|147286454|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
73951411|NCT03844321|147436382|SUPERIORITY|||||||0.425||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.425
73951412|NCT03844321|147436382|SUPERIORITY|||||||0.733||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.733
73951413|NCT03844321|147436383|SUPERIORITY|||||||0.582||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.582
73951414|NCT03844321|147436383|SUPERIORITY|||||||0.666||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.666
73951415|NCT03844321|147436384|SUPERIORITY|||||||0.355||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.355
73951416|NCT03844321|147436384|SUPERIORITY|||||||0.361||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.361
73951417|NCT03844321|147436385|SUPERIORITY|||||||0.64||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.640
73951418|NCT03844321|147436385|SUPERIORITY|||||||0.396||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.396
73978946|NCT01480258|147503711|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-0.7|6.0||||||At least 1 ISR||6.0|-0.7|
73978947|NCT01480258|147503711|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.5|||||TWO_SIDED|95.0|-0.9|5.9||||||At least 1 solicited ISR||5.9|-0.9|
73871642|NCT03058692|147286455|OTHER|||||||0.35||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.35
73978948|NCT01480258|147503711|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-1.1|1.4||||||At least 1 systemic AE||1.4|-1.1|
73978949|NCT01480258|147503711|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-0.5|2.2||||||At least 1 vaccine-related systemic AE||2.2|-0.5|
73978950|NCT01480258|147503711|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-0.5|2.2||||||At least 1 solicited systemic AE||2.2|-0.5|
73978951|NCT01480258|147503711|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.9||||||95.0|-0.4|2.3||||||At least 1 vaccine-related solicited systemic AE||2.3|-0.4|
73978952|NCT01480258|147503712|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|8.2|||||TWO_SIDED|95.0|3.0|13.3||||||Injection-site erythema||13.3|3.0|
73978953|NCT01480258|147503712|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|-1.5|8.3||||||Injection-site pain||8.3|-1.5|
73978954|NCT01480258|147503712|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|7.5||||||95.0|2.1|12.9||||||Injection-site swelling||12.9|2.1|
73978955|NCT01480258|147503713|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-2.5|0.3||||||Injection-site bruising||0.3|-2.5|
73978956|NCT01480258|147503713|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.5|1.6||||||Injection-site haemorrhage||1.6|-1.5|
73978957|NCT01480258|147503713|OTHER||Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-1.2|6.4||||||Injection-site induration||6.4|-1.2|
73978958|NCT01480258|147503713|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.8|1.5||||||Injection-site nodule||1.5|-0.8|
73978959|NCT01480258|147503713|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|1.1||||||95.0|-0.4|2.7||||||Injection-site warmth||2.7|-0.4|
74032839|NCT01856595|147618659|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.12||0.8437|TWO_SIDED|90.0|0.81|1.18||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.18|0.81|0.8437
74032840|NCT01856595|147618660|SUPERIORITY_OR_OTHER||Ratio|1.12|STANDARD_ERROR_OF_MEAN|1.154||0.4405|TWO_SIDED|90.0|0.88|1.42||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.42|0.88|0.4405
73978960|NCT01480258|147503714|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-1.3|5.7||||||Crying||5.7|-1.3|
73978961|NCT01480258|147503714|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.6|||||TWO_SIDED|95.0|-1.6|8.8||||||Decreased appetite||8.8|-1.6|
73978962|NCT01480258|147503714|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-1.0|5.4||||||Irritability||5.4|-1.0|
73978963|NCT01480258|147503714|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|6.4|||||TWO_SIDED|95.0|1.5|11.3||||||Pyrexia||11.3|1.5|
73978964|NCT01480258|147503714|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|5.8|||||TWO_SIDED|95.0|1.7|9.8||||||Somnolence||9.8|1.7|
73978965|NCT01480258|147503714|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-3.2|6.9||||||Vomiting||6.9|-3.2|
73978966|NCT03316170|147503717|SUPERIORITY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.44||0.06|TWO_SIDED|95.0|-1.75|0.3|||t-test, 2 sided|||||0.30|-1.75|.06
73978967|NCT02234141|147503768|OTHER|Nonparametric pairwise comparison|||||=|0.214||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving {1, 2, or greater than or equal to \[≥\] 3}).||||= 0.214
73978968|NCT02234141|147503768|OTHER|Nonparametric pairwise comparison|||||=|0.27||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving \[1, 2, or ≥ 3\]).||||= 0.270
74032841|NCT01856595|147618660|SUPERIORITY_OR_OTHER||Ratio|1.09|STANDARD_ERROR_OF_MEAN|1.146||0.5178|TWO_SIDED|90.0|0.87|1.37||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.37|0.87|0.5178
73978969|NCT02234141|147503768|OTHER|Nonparametric pairwise comparison|||||=|0.604||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test)|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving \[1, 2, or ≥ 3\]).||||= 0.604
73978970|NCT00089791|147503850|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.32|||<|0.0001||95.0|0.26|0.41||Logistic regression was used to generate the p-value|Mantel Haenszel|||||0.41|0.26|<0.0001
73978971|NCT00089791|147503851|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.0106||95.0|0.67|0.95|||Regression, Cox|||||0.95|0.67|0.0106
74032842|NCT01856595|147618661|SUPERIORITY_OR_OTHER||Ratio|0.69|STANDARD_ERROR_OF_MEAN|1.181||0.034|TWO_SIDED|90.0|0.52|0.92||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.92|0.52|0.0340
73978972|NCT00089791|147503852|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6||||0.0362||95.0|0.37|0.97|||Regression, Cox|||||0.97|0.37|0.0362
73978973|NCT01543204|147503873|SUPERIORITY_OR_OTHER||Difference|10.0||||0.4505|TWO_SIDED|95.0|-15.97|35.97|||Wald asymptotic test|||||35.97|-15.97|0.4505
73978974|NCT02449902|147503919|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73978975|NCT02449902|147503920|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANOVA|||||||0.0002
73978976|NCT02449902|147503921|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED||||||ANCOVA|||||||0.0017
73978977|NCT02449902|147503922|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
73978978|NCT02449902|147503923|SUPERIORITY_OR_OTHER|||||||0.9951|TWO_SIDED||||||ANOVA|||||||0.9951
73978979|NCT02449902|147503924|SUPERIORITY_OR_OTHER|||||||0.1429|TWO_SIDED||||||Fisher Exact|||||||0.1429
73978980|NCT02449902|147503925|SUPERIORITY_OR_OTHER|||||||0.1945|TWO_SIDED||||||ANCOVA|||||||0.1945
73978981|NCT02449902|147503926|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
73871643|NCT03058692|147286455|OTHER|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.66
73871644|NCT03058692|147286456|OTHER|||||||0.86||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.86
73871645|NCT03058692|147286456|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
73871646|NCT00571974|147286475|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||One-sided exact binomial test to compare the observed response rate to the 20% rate envisioned under the original null hypothesis.|One-sided exact binomial test|Because all but one subject responded to treatment, the Fisher's exact test was addedd.||The Simon two-stage minimax design with 9 subjects in the first stage and 8 subjects in the second stage, yielding 17 subjects overall. This design's early termination rule was ≤3/9 responses in the first stage, and its success criterion was ≥7/17 responses overall. This design had 80% power at 5% alpha to distinguish an efficacious 50% response rate from a null-hypothesis 20% response rate.||||0.0001
73871647|NCT01724866|147286498|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.72||||0.296|TWO_SIDED|95.0|0.19|1.27|||Bootstrap method|||A 2-sided 95% confidence interval (CI) for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||1.27|0.19|0.296
73871648|NCT01724866|147286498|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.14||||0.002|TWO_SIDED|95.0|-0.28|0.64|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.64|-0.28|0.002
74032843|NCT01856595|147618661|SUPERIORITY_OR_OTHER||Ratio|1.2|STANDARD_ERROR_OF_MEAN|1.173||0.2519|TWO_SIDED|90.0|0.92|1.58||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.58|0.92|0.2519
74032844|NCT01856595|147618662|SUPERIORITY_OR_OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|1.079||0.4579|TWO_SIDED|90.0|0.93|1.2||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.20|0.93|0.4579
73978982|NCT02449902|147503927|SUPERIORITY_OR_OTHER|||||||0.182|TWO_SIDED||||||ANCOVA|||||||0.1820
73978983|NCT02449902|147503928|SUPERIORITY_OR_OTHER|||||||0.0401|TWO_SIDED||||||ANCOVA|||||||0.0401
73978984|NCT02362789|147503929|SUPERIORITY||Mean Difference (Net)|-18.3||||0.0055|TWO_SIDED|95.0|-31.01|-5.59|||ANCOVA|||||-5.59|-31.01|0.0055
73978985|NCT02852824|147503943|OTHER||Slope|0.9058|STANDARD_ERROR_OF_MEAN|0.0523|||TWO_SIDED|95.0|0.7973|1.0142||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used a statistical method.||1.0142|0.7973|
73978986|NCT02852824|147503944|OTHER||Slope|0.9528|STANDARD_ERROR_OF_MEAN|0.0454|||TWO_SIDED|95.0|0.8581|1.0475||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0475|0.8581|
73978987|NCT02852824|147503945|OTHER||Slope|0.9439|STANDARD_ERROR_OF_MEAN|0.0358|||TWO_SIDED|95.0|0.8697|1.0182||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0182|0.8697|
73978988|NCT02852824|147503946|OTHER||Slope|0.9708|STANDARD_ERROR_OF_MEAN|0.0351|||TWO_SIDED|95.0|0.8975|1.044||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0440|0.8975|
73978989|NCT03775213|147503947|SUPERIORITY||Risk Ratio (RR)|1.53|||||TWO_SIDED|95.0|0.91|2.58||||||||2.58|.91|
73978990|NCT03775213|147503948|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.49|1.88||||||Active Monitoring||1.88|.49|
73978991|NCT03775213|147503948|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.79|1.41||||||Lumpectomy||1.41|.79|
73978992|NCT03775213|147503948|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.62|1.3||||||Lumpectomy with Radiation||1.30|.62|
73978993|NCT03775213|147503948|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.48|1.47||||||Mastectomy||1.47|.48|
73978994|NCT03775213|147503949|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.59|1.98||||||||1.98|.59|
73978995|NCT03775213|147503950|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.65|1.45||||||||1.45|.65|
73978996|NCT03775213|147503951|SUPERIORITY||Slope|0.09|||||TWO_SIDED|95.0|-0.2|0.38||||||||.38|-.20|
73978997|NCT00786188|147503968|SUPERIORITY_OR_OTHER|||||||0.0177||||||Week 4 frequency|Repeated measures analysis|||||||0.0177
73978998|NCT00786188|147503968|SUPERIORITY_OR_OTHER|||||||0.0541||||||Week 8 frequency|Reapeated measures analysis|||||||0.0541
74032845|NCT01856595|147618662|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.079||0.8144|TWO_SIDED|90.0|0.87|1.11||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.11|0.87|0.8144
74032846|NCT01856595|147618662|SUPERIORITY_OR_OTHER||Ratio|0.93|STANDARD_ERROR_OF_MEAN|1.082||0.3425|TWO_SIDED|90.0|0.81|1.06||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.06|0.81|0.3425
74032847|NCT01856595|147618662|SUPERIORITY_OR_OTHER||Ratio|1.0|STANDARD_ERROR_OF_MEAN|1.076||0.967|TWO_SIDED|90.0|0.88|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.13|0.88|0.9670
74032848|NCT01856595|147618662|SUPERIORITY_OR_OTHER||Ratio|1.08|STANDARD_ERROR_OF_MEAN|1.079||0.319|TWO_SIDED|90.0|0.95|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.23|0.95|0.3190
73871649|NCT01724866|147286498|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.56|-0.06|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-values was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||-0.06|-0.56|<0.001
73871650|NCT01724866|147286499|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.38||||0.001|TWO_SIDED|95.0|0.06|0.74|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.74|0.06|0.001
73871651|NCT01724866|147286499|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.04|||<|0.001|TWO_SIDED|95.0|-0.16|0.24|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.24|-0.16|<0.001
73871652|NCT01724866|147286499|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.19|0.06|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.06|-0.19|<0.001
73871653|NCT01724866|147286500|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.31||||0.002|TWO_SIDED|95.0|-0.07|0.72|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.72|-0.07|0.002
73871654|NCT01724866|147286500|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.02|||<|0.001|TWO_SIDED|95.0|-0.27|0.3|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.30|-0.27|<0.001
74032849|NCT01856595|147618663|SUPERIORITY_OR_OTHER||Ratio|1.14|STANDARD_ERROR_OF_MEAN|1.095||0.1617|TWO_SIDED|90.0|0.98|1.32||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.32|0.98|0.1617
74032850|NCT01856595|147618663|SUPERIORITY_OR_OTHER||Ratio|1.08|STANDARD_ERROR_OF_MEAN|1.084||0.3703|TWO_SIDED|90.0|0.94|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.23|0.94|0.3703
74032851|NCT01856595|147618664|SUPERIORITY_OR_OTHER||Ratio|0.95|STANDARD_ERROR_OF_MEAN|1.119||0.6833|TWO_SIDED|90.0|0.79|1.15||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.15|0.79|0.6833
74032852|NCT01856595|147618664|SUPERIORITY_OR_OTHER||Ratio|1.18|STANDARD_ERROR_OF_MEAN|1.112||0.1318|TWO_SIDED|90.0|0.98|1.41||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.41|0.98|0.1318
74032853|NCT00458406|147618694|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||95.0|||||t-test, 2 sided|||"We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~Description of power calculation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% confidence interval (CI) for the difference between the 2 means had a range of 1.282 standard deviation (SD)."||||0.512
74032854|NCT00458406|147618695|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
73871655|NCT01724866|147286500|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.01|||<|0.001|TWO_SIDED|95.0|-0.27|0.28|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.28|-0.27|<0.001
73871656|NCT01724866|147286501|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.94||||0.781|TWO_SIDED|95.0|-0.01|2.47|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||2.47|-0.01|0.781
73871657|NCT01724866|147286501|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.07|||<|0.001|TWO_SIDED|95.0|-0.17|0.38|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.38|-0.17|<0.001
73871658|NCT01724866|147286501|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.02|||<|0.001|TWO_SIDED|95.0|-0.23|0.22|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.22|-0.23|<0.001
73871659|NCT01724866|147286502|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.002|TWO_SIDED|95.0|1.1|1.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.8|1.1|0.002
73871660|NCT01724866|147286502|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.711|TWO_SIDED|95.0|0.6|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.6|0.711
73871661|NCT01724866|147286502|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.028|TWO_SIDED|95.0|0.1|0.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||0.9|0.1|0.028
73871662|NCT01724866|147286503|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.672|TWO_SIDED|95.0|0.8|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.8|0.672
73871663|NCT01724866|147286503|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.348|TWO_SIDED|95.0|0.5|1.3|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.3|0.5|0.348
73871664|NCT01724866|147286503|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.973|TWO_SIDED|95.0|0.4|2.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||2.9|0.4|0.973
73871665|NCT01724866|147286504|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.618|TWO_SIDED|95.0|0.8|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.8|0.618
73871666|NCT01724866|147286504|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.661|TWO_SIDED|95.0|0.5|1.6|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.6|0.5|0.661
73871667|NCT01724866|147286504|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.754|TWO_SIDED|95.0|0.3|2.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||2.8|0.3|0.754
73871668|NCT01724866|147286505|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.009|TWO_SIDED|95.0|1.1|1.7|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.7|1.1|0.009
73871669|NCT01724866|147286505|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.527|TWO_SIDED|95.0|0.7|1.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.8|0.7|0.527
73871670|NCT01724866|147286505|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.815|TWO_SIDED|95.0|0.4|3.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||3.9|0.4|0.815
73871671|NCT01724866|147286506|SUPERIORITY|||||||0.008|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.008
73871672|NCT01724866|147286506|SUPERIORITY|||||||0.911|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.911
73871673|NCT01724866|147286506|SUPERIORITY|||||||0.002|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.002
73871674|NCT01724866|147286507|SUPERIORITY|||||||0.005|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.005
73871675|NCT01724866|147286507|SUPERIORITY|||||||0.633|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.633
73871676|NCT01724866|147286507|SUPERIORITY|||||||0.027|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.027
73871677|NCT01724866|147286508|SUPERIORITY|||||||0.015|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.015
73871678|NCT01724866|147286508|SUPERIORITY|||||||0.571|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.571
73978999|NCT00786188|147503969|SUPERIORITY_OR_OTHER|||||||0.0644||||||Week 4 severity|Reapeated measures analysis|||||||0.0644
73979000|NCT00786188|147503969|SUPERIORITY_OR_OTHER|||||||0.0364||||||Week 8 severity|Reapeated measures analysis|||||||0.0364
73979001|NCT03787628|147503983|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.703||||0.41|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of cue-induced craving.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on the measure of cue-induced craving (degrees of freedom = 1, 67).|||||0.41
73979002|NCT03787628|147503984|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.0||||0.99|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of spontaneous craving.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on spontaneous craving (degrees of freedom = 1, 550).|||||0.99
73951419|NCT03844321|147436386|SUPERIORITY|||||||0.004||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.004
73951420|NCT03844321|147436386|SUPERIORITY|||||||0.291||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.291
73951421|NCT03844321|147436387|SUPERIORITY|||||||0.603||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.603
73951422|NCT03844321|147436387|SUPERIORITY|||||||0.333||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.333
73951423|NCT03844321|147436388|SUPERIORITY|||||||0.224||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.224
73951424|NCT03844321|147436388|SUPERIORITY|||||||0.885||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.885
73951425|NCT03844321|147436389|SUPERIORITY|||||||0.49||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.490
73979003|NCT03787628|147503985|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.04||||0.84|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of state anxiety.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on state anxiety (degrees of freedom = 1, 550)|||||0.84
73979004|NCT03787628|147503986|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.27||||0.6|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of negative affect.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on negative affect (degrees of freedom = 1, 550).|||||0.60
73979005|NCT03928743|147503987|SUPERIORITY||Odds Ratio (OR)|2.88|||<|0.001|TWO_SIDED|95.0|1.71|4.87|||Regression, Logistic|||||4.87|1.71|<0.001
73979006|NCT03928743|147503988|SUPERIORITY||Odds Ratio (OR)|2.8|||<|0.001|TWO_SIDED|95.0|1.59|4.93|||Regression, Logistic|||||4.93|1.59|<0.001
73979007|NCT03928743|147503989|SUPERIORITY||Odds Ratio (OR)|2.66|||<|0.001|TWO_SIDED|95.0|1.65|4.28|||Regression, Logistic|||||4.28|1.65|<0.001
73979008|NCT03928743|147503990|SUPERIORITY||LS Mean difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.48|-0.59|||Regression, Logistic|||||-0.59|-1.48|<0.001
73979009|NCT03928743|147503991|SUPERIORITY||Odds Ratio (OR)|4.26|||<|0.001|TWO_SIDED|95.0|1.93|9.39|||Regression, Logistic|||||9.39|1.93|<0.001
73979010|NCT03928743|147503992|SUPERIORITY||Odds Ratio (OR)|6.47|||<|0.001|TWO_SIDED|95.0|2.67|15.65|||Regression, Logistic|||||15.65|2.67|<0.001
73979011|NCT03928743|147503993|SUPERIORITY||Odds Ratio (OR)|4.65|||<|0.001|TWO_SIDED|4.65|2.51|7.57|||Regression, Logistic|||||7.57|2.51|<0.001
73979012|NCT03928743|147503994|SUPERIORITY||LS Mean difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.48|-0.63|||Regression, Logistic|||||-0.63|-1.48|<0.001
73871679|NCT01724866|147286508|SUPERIORITY|||||||0.066|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.066
73951426|NCT03844321|147436389|SUPERIORITY|||||||0.266||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.266
73951427|NCT03844321|147436390|SUPERIORITY|||||||0.928||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.928
73951428|NCT03844321|147436390|SUPERIORITY|||||||0.307||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.307
73951429|NCT01374802|147436474|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.29|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|101.36|131.13|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||131.13|101.36|
73951430|NCT01374802|147436475|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|87.91|STANDARD_DEVIATION|38.3|||TWO_SIDED|90.0|68.609|112.63|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||112.630|68.609|
73951431|NCT01374802|147436476|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|128.41|STANDARD_DEVIATION|15.6|||TWO_SIDED|90.0|115.724|142.489|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||142.489|115.724|
73951432|NCT02559609|147436487|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1||||.028
73951433|NCT02559609|147436488|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1)||||.027
73951434|NCT02559609|147436489|SUPERIORITY|||||||0.66|||||||ANOVA|df = 1||Group A/B (contrast -1) was compared to Group C/D (contrast 1) to test Aim 2.||||.66
73951435|NCT02559609|147436490|SUPERIORITY|||||||0.89|||||||Regression, Cox|||Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.||||.89
73951436|NCT02559609|147436491|SUPERIORITY|||||||0.58|||||||ANOVA|df = 1||Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.||||.58
73951437|NCT02559609|147436492|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1.||||.024
73951438|NCT00064025|147436493|SUPERIORITY_OR_OTHER|||||||0.701|||||||Fisher Exact|||||||0.701
73951439|NCT00064025|147436494|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||||||<.001
73951440|NCT00064025|147436495|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||||||<.001
73951441|NCT03277378|147436512|NON_INFERIORITY|The hypothesis was tested at the 5% significance level.||||||0.0003|||||||Farrington- Manning non-inferioirty test|||"The hypothesis was formally addressed as:~H0: AB - TB ≤ -15% H1: AB - TB \> -15% where AB = permanent system qualification rate of Group 1 (AB) TB = permanent system qualification rate of Group 2 (TB)"||||0.0003
73951442|NCT03277378|147436513|OTHER|||||||0.25|||||||Chi-squared|||"The hypothesis was formally addressed as:~H0: P ≤ 60% H1: P \> 60% where P= percentage of physician prefer anatomic placement over targeted placement.~The analysis population included physicians who have performed both placement procedures. The hypothesis was tested at the 5% significance level."||||0.2500
73979013|NCT03928743|147503995|SUPERIORITY||LS Mean difference|-1.48|||<|0.001|TWO_SIDED|95.0|-2.0|-0.96|||Regression, Logistic|||||-0.96|-2.00|<0.001
73979014|NCT03928743|147503996|SUPERIORITY||LS Mean difference|-1.52|||<|0.001|TWO_SIDED|95.0|-2.36|-0.68|||Regression, Logistic|||||-0.68|-2.36|<0.001
73979015|NCT03928743|147503997|SUPERIORITY||LS Mean difference|3.38|||<|0.001|TWO_SIDED|95.0|1.67|5.09|||Regression, Logistic|||||5.09|1.67|<0.001
73979016|NCT03928743|147503998|SUPERIORITY||LS Mean difference|-0.28||||0.006|TWO_SIDED|95.0|-0.47|-0.08|||Regression, Logistic|||||-0.08|-0.47|0.006
73979017|NCT03928743|147503999|SUPERIORITY||LS Mean difference|-1.08||||0.003|TWO_SIDED|95.0|-1.79|-0.38|||Regression, Logistic|||||-0.38|-1.79|0.003
73979018|NCT03928743|147504000|SUPERIORITY||Odds Ratio (OR)|2.47||||0.006|TWO_SIDED|95.0|1.3|4.68|||Regression, Logistic|||||4.68|1.30|0.006
73979019|NCT02236611|147504009|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis: the difference between the trt means (umeclidinium minus glycopyrronium) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to glycopyrronium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to glycopyrronium.|Mean Difference (Final Values)|0.024||||0.1|TWO_SIDED|95.0|-0.005|0.054|||Mixed Models Analysis|||||0.054|-0.005|0.100
73871680|NCT01724866|147286509|SUPERIORITY|||||||0.106|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.106
73871681|NCT01724866|147286509|SUPERIORITY|||||||0.156|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.156
73871682|NCT01724866|147286509|SUPERIORITY|||||||0.005|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.005
73871683|NCT01724866|147286510|SUPERIORITY||Ratio|0.4|||||TWO_SIDED|95.0|0.25|0.8||||||||0.80|0.25|
73951443|NCT01370603|147436534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence was declared if the 97.5% expanded confidence interval for the mean difference between the fixed-dose combination and co-administration in percent change from baseline was contained within ±4%.|Difference in Least-squares means|-0.2|||||TWO_SIDED|97.5|-1.9|1.4|||ANCOVA|||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.08% and that the standard deviation of the difference is 12.8%.||1.4|-1.9|
73951444|NCT01370603|147436535|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.1|||||TWO_SIDED|97.5|-1.4|1.2|||ANCOVA|||||1.2|-1.4|
73979020|NCT01450007|147504010|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
73979021|NCT01450007|147504011|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
74032855|NCT00458406|147618696|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
73979022|NCT01450007|147504012|SUPERIORITY_OR_OTHER|||||||0.76|||||||ANOVA|||||||0.76
73979023|NCT01450007|147504013|SUPERIORITY_OR_OTHER|||||||0.61|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 24 hours.||||0.61
73871684|NCT01724866|147286510|SUPERIORITY||Ratio|1.0|||||TWO_SIDED|95.0|0.53|2.04||||||||2.04|0.53|
73871685|NCT01724866|147286510|SUPERIORITY||Ratio|2.5|||||TWO_SIDED|95.0|1.4|4.54||||||||4.54|1.40|
73871686|NCT01724866|147286511|SUPERIORITY||Ratio|0.5|||||TWO_SIDED|95.0|0.3|0.8||||||||0.80|0.30|
73871687|NCT01724866|147286511|SUPERIORITY||Ratio|1.1|||||TWO_SIDED|95.0|0.7|1.79||||||||1.79|0.70|
73871688|NCT01724866|147286511|SUPERIORITY||Ratio|1.7|||||TWO_SIDED|95.0|1.07|2.79||||||||2.79|1.07|
73871689|NCT01724866|147286512|SUPERIORITY||Ratio|0.5|||||TWO_SIDED|95.0|0.34|0.89||||||||0.89|0.34|
73951445|NCT01370603|147436536|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.3|||||TWO_SIDED|97.5|-1.8|1.2|||ANCOVA|||||1.2|-1.8|
73951446|NCT01370603|147436537|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-0.2|||||TWO_SIDED|97.5|-1.7|1.4|||ANCOVA|||||1.4|-1.7|
73951447|NCT01370603|147436538|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.5|||||TWO_SIDED|97.5|-1.9|1.0|||ANCOVA|||||1.0|-1.9|
73979024|NCT01450007|147504013|SUPERIORITY_OR_OTHER|||||||0.13|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 48 hours.||||0.13
73979025|NCT01450007|147504013|SUPERIORITY_OR_OTHER|||||||0.25|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 1 week.||||0.25
73979026|NCT01335061|147504014|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||||||<0.0001
73979027|NCT01536704|147504025|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.91|||||TWO_SIDED|90.0|0.88|0.94|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.94|0.88|
74032856|NCT00458406|147618697|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||"Chi-Square test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
73871690|NCT01724866|147286512|SUPERIORITY||Ratio|1.1|||||TWO_SIDED|95.0|0.71|1.85||||||||1.85|0.71|
73871691|NCT01724866|147286512|SUPERIORITY||Ratio|1.6|||||TWO_SIDED|95.0|0.97|2.49||||||||2.49|0.97|
73871692|NCT01724866|147286513|SUPERIORITY||Ratio|0.7|||||TWO_SIDED|95.0|0.4|1.1||||||||1.10|0.40|
73871693|NCT01724866|147286513|SUPERIORITY||Ratio|1.4|||||TWO_SIDED|95.0|0.87|2.38||||||||2.38|0.87|
73871694|NCT01724866|147286513|SUPERIORITY||Ratio|1.9|||||TWO_SIDED|95.0|1.23|2.96||||||||2.96|1.23|
73871695|NCT01724866|147286518|SUPERIORITY||Percent Difference|2.1||||1|TWO_SIDED|95.0|-20.2|24.9|||Fisher Exact|||||24.9|-20.2|1.000
73871696|NCT01724866|147286518|SUPERIORITY||Percent Difference|-2.8||||1|TWO_SIDED|95.0|-26.7|21.4|||Fisher Exact|||||21.4|-26.7|1.000
73871697|NCT01724866|147286518|SUPERIORITY||Percent Difference|-2.8||||1|TWO_SIDED|95.0|-26.7|21.4|||Fisher Exact|||||21.4|-26.7|1.000
73871698|NCT01724866|147286520|SUPERIORITY||Percent Difference|-6.2||||0.469|TWO_SIDED|95.0|-28.5|16.9|||Fisher Exact|||||16.9|-28.5|0.469
73871699|NCT01724866|147286520|SUPERIORITY||Percent Difference|-5.6||||0.71|TWO_SIDED|95.0|-29.3|18.7|||Fisher Exact|||||18.7|-29.3|0.710
73871700|NCT01724866|147286520|SUPERIORITY||Percent Difference|-11.1||||0.199|TWO_SIDED|95.0|-34.6|13.3|||Fisher Exact|||||13.3|-34.6|0.199
73871701|NCT01980095|147286552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||One-sample Z-test, RHB-105 subjects only|||||||0.001
73951448|NCT01370603|147436539|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|0.0|||||TWO_SIDED|97.5|-4.9|4.9|||constrained Longitudinal Data Analysis|||||4.9|-4.9|
74032857|NCT00458406|147618698|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP. The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||||>0.05
73951449|NCT00518713|147436540|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Analysis of covariance (ANCOVA) with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0120
73951450|NCT00518713|147436540|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0015
73951451|NCT00518713|147436540|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
73951452|NCT00518713|147436541|SUPERIORITY_OR_OTHER|||||||0.0027||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0027
73951453|NCT00518713|147436541|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
73951454|NCT00518713|147436541|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
73951455|NCT00518713|147436542|SUPERIORITY_OR_OTHER|||||||0.1041||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1041
73951456|NCT00518713|147436542|SUPERIORITY_OR_OTHER|||||||0.2207||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.2207
73951457|NCT00518713|147436542|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0025
73951458|NCT00518713|147436543|SUPERIORITY_OR_OTHER|||||||0.1469||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1469
73951459|NCT00518713|147436543|SUPERIORITY_OR_OTHER|||||||0.0161||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0161
73951460|NCT00518713|147436543|SUPERIORITY_OR_OTHER|||||||0.0024||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0024
73951461|NCT00518713|147436544|SUPERIORITY_OR_OTHER|||||||0.1324||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1324
73951462|NCT00518713|147436544|SUPERIORITY_OR_OTHER|||||||0.0026||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0026
73951463|NCT00518713|147436544|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0004
73951464|NCT00518713|147436544|SUPERIORITY_OR_OTHER|||||||0.3383||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.3383
73951465|NCT00518713|147436544|SUPERIORITY_OR_OTHER|||||||0.0159||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0159
73979028|NCT01536704|147504025|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.98|1.05|||Wilcoxon Signed Rank test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.05|0.98|
73979029|NCT01536704|147504026|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.85|0.94|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.94|0.85|
73979030|NCT01536704|147504026|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.02|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.02|0.93|
73979031|NCT01536704|147504027|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.92||||||90.0|0.88|0.95|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.95|0.88|
73979032|NCT01536704|147504027|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.98|1.06|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.06|0.98|
73979033|NCT01536704|147504028|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0006||||0.1491||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.1491
73979034|NCT01536704|147504028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0005||||0.679||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.6790
73979035|NCT01536704|147504029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0641||||0.5619||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5619
73871702|NCT03223337|147286554|OTHER||Ratio of Geometric Least Square(LS) Mean|1.9973|||||TWO_SIDED|90.0|1.1063|3.6057|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.6057|1.1063|
73979036|NCT01536704|147504029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0538||||0.4523||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.4523
73979037|NCT01536704|147504030|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0025||||0.5113||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5113
73979038|NCT01536704|147504030|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.0042||||0.537||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5370
73979039|NCT00240994|147504038|SUPERIORITY_OR_OTHER||Proportion with graft loss or death|0.057|||||TWO_SIDED|95.0|0.007|0.192|||95% Confidence Interval|95% CI using an exact binomial method||The proportion of participants with graft loss or death within 12 months post kidney transplantation is descriptively summarized with a 95% confidence interval using an exact binomial method.||0.192|0.007|
73979040|NCT00854594|147504040|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: pre-intervention efficacies will be equal in the two study arms.||||0.26
73979041|NCT00854594|147504041|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: post-intervention efficacies will be equal in the two study arms.||||0.74
73979042|NCT00749944|147504043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.72|||||TWO_SIDED|95.0|-0.33|1.77||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.77|-0.33|
73871703|NCT03223337|147286554|OTHER||Ratio of Geometric LS Mean|1.6471|||||TWO_SIDED|90.0|1.1267|2.4079|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.4079|1.1267|
73871704|NCT03223337|147286554|OTHER||Ratio of Geometric LS Mean|1.6404|||||TWO_SIDED|90.0|1.0744|2.5048|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.5048|1.0744|
73979043|NCT00749944|147504043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.46|||||TWO_SIDED|95.0|-0.5|1.43||||||Period AC: Difference varenicline versus placebo.||1.43|-0.50|
73979044|NCT00749944|147504043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.92|||||TWO_SIDED|95.0|-0.27|2.11||||||Period AD: Difference varenicline versus placebo.||2.11|-0.27|
73979045|NCT00749944|147504043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-0.52|1.53||||||Period AE: Difference varenicline versus placebo.||1.53|-0.52|
73979046|NCT00749944|147504043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.35|0.5|||||Mixed Models Analysis|Period BC: Difference varenicline versus placebo.||0.50|-1.35|
74032858|NCT00458406|147618698|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||<0.05
74032859|NCT00458406|147618700|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
74032860|NCT00458406|147618701|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
74032861|NCT03521154|147618703|SUPERIORITY||Hazard Ratio (HR)|0.16|||<|0.001|TWO_SIDED|95.0|0.1|0.24|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.24|0.10|<0.001
73979047|NCT00749944|147504043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-1.18|1.24||||||Period BD: Difference varenicline versus placebo.||1.24|-1.18|
73871705|NCT03223337|147286554|OTHER||Ratio of Geometric LS Mean|1.4931|||||TWO_SIDED|90.0|1.0876|2.0498|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.0498|1.0876|
73871706|NCT03223337|147286554|OTHER||Ratio of Geometric LS Mean|1.6222|||||TWO_SIDED|90.0|1.1594|2.2696|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.2696|1.1594|
73979048|NCT00749944|147504043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.37|||||TWO_SIDED|95.0|-1.37|0.63|||||Mixed Models Analysis|Period BE: Difference varenicline versus placebo.||0.63|-1.37|
73979049|NCT00749944|147504044|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.62|||||TWO_SIDED|95.0|-0.15|1.39||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.39|-0.15|
73979050|NCT00749944|147504044|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.41|||||TWO_SIDED|95.0|-0.24|1.07||||||Period AC: Difference varenicline versus placebo.||1.07|-0.24|
73979051|NCT00749944|147504044|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.48|||||TWO_SIDED|95.0|-0.26|1.22||||||Period AD: Difference varenicline versus placebo.||1.22|-0.26|
73979052|NCT00749944|147504044|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.44|||||TWO_SIDED|95.0|-0.18|1.06||||||Period AE: Difference varenicline versus placebo.||1.06|-0.18|
73979053|NCT00749944|147504044|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.58|0.78||||||Period BC: Difference varenicline versus placebo.||0.78|-0.58|
73979054|NCT00749944|147504044|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.22|||||TWO_SIDED|95.0|-0.48|0.92||||||Period BD: Difference varenicline versus placebo.||0.92|-0.48|
73979055|NCT00749944|147504044|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.23|||||TWO_SIDED|95.0|-0.26|0.72||||||Period BE: Difference varenicline versus placebo.||0.72|-0.26|
73979056|NCT00749944|147504045|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.62|||||TWO_SIDED|95.0|0.0|1.24||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.24|-0.00|
74032862|NCT03521154|147618704|SUPERIORITY||Hazard Ratio (HR)|0.17|||||TWO_SIDED|95.0|0.1|0.29|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|PFS in Ex19Del positive patients||0.29|0.10|
74032863|NCT03521154|147618704|SUPERIORITY||Hazard Ratio (HR)|0.32||||||95.0|0.19|0.56|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|PFS in L858R positive patients||0.56|0.19|
74032864|NCT03521154|147618705|SUPERIORITY||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.15|0.34|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|Negative at screening||0.34|0.15|
74032865|NCT03521154|147618706|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.09|0.32|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.32|0.09|<0.001
74032866|NCT03521154|147618708|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.53|TWO_SIDED|95.0|0.42|1.56|||Log Rank||A hazard ratio \< 1 favours osimertinib|||1.56|0.42|0.530
74032867|NCT03521154|147618709|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.54|5.08|||Regression, Logistic||An odds ratio \> 1 favours osimertinib|||5.08|1.54|<0.001
74032868|NCT03521154|147618711|SUPERIORITY||Odds Ratio (OR)|2.06||||0.069|TWO_SIDED|95.0|0.94|4.47|||Regression, Logistic||An odds ratio \> 1 favours osimertinib.|||4.47|0.94|0.069
74032869|NCT03521154|147618714|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.38|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.38|0.11|<0.001
74032870|NCT03521154|147618715|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.14|0.32|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.32|0.14|<0.001
73951466|NCT00518713|147436544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
74032871|NCT03521154|147618716|SUPERIORITY||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.21|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.21|0.08|<0.001
73951467|NCT00518713|147436544|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0279
73951468|NCT00518713|147436544|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0010
73951469|NCT00518713|147436544|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
73951470|NCT00518713|147436551|SUPERIORITY_OR_OTHER|||||||0.721||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.7210
73951471|NCT00518713|147436551|SUPERIORITY_OR_OTHER|||||||0.2505||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.2505
73951472|NCT00518713|147436551|SUPERIORITY_OR_OTHER|||||||0.0924||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0924
73951473|NCT00518713|147436552|SUPERIORITY_OR_OTHER|||||||0.0414||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0414
74032872|NCT03521154|147618717|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.022|TWO_SIDED|95.0|0.28|0.91|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.91|0.28|0.022
73951474|NCT00518713|147436552|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0044
73951475|NCT00518713|147436552|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
73951476|NCT02404493|147436577|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73951477|NCT02404493|147436577|SUPERIORITY_OR_OTHER|||||||0.023||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.023
73951478|NCT02404493|147436577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|422.81|STANDARD_ERROR_OF_MEAN|122.905||0.003|TWO_SIDED|95.0|166.435|679.186||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||679.186|166.435|0.003
73951479|NCT02404493|147436578|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73951480|NCT02404493|147436578|SUPERIORITY_OR_OTHER|||||||0.754||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.754
73951481|NCT02404493|147436578|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|52.3|STANDARD_ERROR_OF_MEAN|19.21||0.013|TWO_SIDED|95.0|12.23|92.373||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||92.373|12.230|0.013
73951482|NCT02404493|147436579|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73951483|NCT02404493|147436579|SUPERIORITY_OR_OTHER|||||||0.271||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.271
73979057|NCT00749944|147504045|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.73|||||TWO_SIDED|95.0|0.18|1.29||||||Period AC: Difference varenicline versus placebo.||1.29|0.18|
73979058|NCT00749944|147504045|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.66|||||TWO_SIDED|95.0|0.02|1.3||||||Period AD: Difference varenicline versus placebo.||1.30|0.02|
73979059|NCT00749944|147504045|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.43|||||TWO_SIDED|95.0|-0.19|1.05||||||Period AE: Difference varenicline versus placebo.||1.05|-0.19|
73951484|NCT02404493|147436579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|167.95|STANDARD_ERROR_OF_MEAN|48.21||0.002|TWO_SIDED|95.0|67.046|268.854||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||268.854|67.046|0.002
73951485|NCT02404493|147436580|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
73951486|NCT02404493|147436580|SUPERIORITY_OR_OTHER|||||||0.26||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.260
73951487|NCT02404493|147436580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|221.97|STANDARD_ERROR_OF_MEAN|100.674||0.04|TWO_SIDED|95.0|11.254|432.68||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||432.680|11.254|0.040
73951488|NCT02404493|147436581|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73979060|NCT00749944|147504045|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.48|||||TWO_SIDED|95.0|-0.09|1.05||||||Period BC: Difference varenicline versus placebo.||1.05|-0.09|
73979061|NCT00749944|147504045|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.39|||||TWO_SIDED|95.0|-0.28|1.06||||||Period BD: Difference varenicline versus placebo.||1.06|-0.28|
73979062|NCT00749944|147504045|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-0.47|0.65||||||Period BE: Difference varenicline versus placebo.||0.65|-0.47|
73979063|NCT00749944|147504046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.85|||||TWO_SIDED|95.0|-0.02|1.72|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.72|-0.02|
73871707|NCT03223337|147286554|OTHER||Ratio of Geometric LS Mean|1.3145|||||TWO_SIDED|90.0|0.9896|1.7462|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7462|0.9896|
73871708|NCT03223337|147286555|OTHER||Ratio of Geometric LS Mean|1.4574|||||TWO_SIDED|90.0|1.035|2.0523|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.0523|1.0350|
73871709|NCT03223337|147286555|OTHER||Ratio of Geometric LS Mean|1.9375|||||TWO_SIDED|90.0|1.3919|2.6968|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.6968|1.3919|
73951489|NCT02404493|147436581|SUPERIORITY_OR_OTHER|||||||0.22||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.220
73951490|NCT02404493|147436581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|194.0|STANDARD_ERROR_OF_MEAN|68.461||0.011|TWO_SIDED|95.0|50.712|337.291||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||337.291|50.712|0.011
73951491|NCT02404493|147436582|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
73951492|NCT02404493|147436582|SUPERIORITY_OR_OTHER|||||||0.06||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.060
73951493|NCT02404493|147436582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|134.9|STANDARD_ERROR_OF_MEAN|79.567||0.107|TWO_SIDED|95.0|-32.266|302.063||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||302.063|-32.266|0.107
73951494|NCT02404493|147436583|SUPERIORITY_OR_OTHER|||||||0.692||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.692
73951495|NCT02404493|147436583|SUPERIORITY_OR_OTHER|||||||0.541||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.541
73979064|NCT00749944|147504046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.85|||||TWO_SIDED|95.0|0.16|1.54|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||1.54|0.16|
73979065|NCT00749944|147504046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.24|||||TWO_SIDED|95.0|0.39|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||2.08|0.39|
73979066|NCT00749944|147504046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.83|||||TWO_SIDED|95.0|0.14|1.52|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||1.52|0.14|
73979067|NCT00749944|147504046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.52|||||TWO_SIDED|95.0|-0.06|1.09|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||1.09|-0.06|
73951496|NCT02404493|147436583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.492|TWO_SIDED|95.0|-0.25|0.502||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.502|-0.250|0.492
73951497|NCT02404493|147436584|SUPERIORITY_OR_OTHER|||||||0.017||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.017
73871710|NCT03223337|147286555|OTHER||Ratio of Geometric LS Mean|1.8312|||||TWO_SIDED|90.0|1.3342|2.5133|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5133|1.3342|
73979068|NCT00749944|147504046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.88|||||TWO_SIDED|95.0|0.05|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||1.70|0.05|
73979069|NCT00749944|147504046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.38|||||TWO_SIDED|95.0|-0.12|0.88|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.88|-0.12|
73871711|NCT03223337|147286555|OTHER||Ratio of Geometric LS Mean|2.003|||||TWO_SIDED|90.0|1.4654|2.7378|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7378|1.4654|
73871712|NCT03223337|147286555|OTHER||Ratio of Geometric LS Mean|1.7113|||||TWO_SIDED|90.0|1.2818|2.2847|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.2847|1.2818|
73951498|NCT02404493|147436584|SUPERIORITY_OR_OTHER|||||||0.223||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.223
73979070|NCT00749944|147504047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.82|||||TWO_SIDED|95.0|-3.07|1.43|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.43|-3.07|
73979071|NCT00749944|147504047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.19|||||TWO_SIDED|95.0|-2.47|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||2.08|-2.47|
73979072|NCT00749944|147504047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-2.15|||||TWO_SIDED|95.0|-5.19|0.89|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.89|-5.19|
73979073|NCT00749944|147504047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.98|||||TWO_SIDED|95.0|-3.67|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||1.70|-3.67|
73979074|NCT00749944|147504047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.95|||||TWO_SIDED|95.0|-0.36|4.26|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||4.26|-0.36|
73979075|NCT00749944|147504047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-3.32|3.3|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||3.30|-3.32|
73979076|NCT00749944|147504047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.09|||||TWO_SIDED|95.0|-1.8|3.97|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||3.97|-1.80|
73979077|NCT00749944|147504048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.52|||||TWO_SIDED|95.0|-0.29|1.32|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.32|-0.29|
73979078|NCT00749944|147504048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.54|||||TWO_SIDED|95.0|-0.17|1.25|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||1.25|-0.17|
73979079|NCT00749944|147504048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.18|||||TWO_SIDED|95.0|-0.55|0.92|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.92|-0.55|
73979080|NCT00749944|147504048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.26|||||TWO_SIDED|95.0|-0.46|0.99|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||0.99|-0.46|
73979081|NCT00749944|147504048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.59|||||TWO_SIDED|95.0|-0.19|1.37|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||1.37|-0.19|
73979082|NCT00749944|147504048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.91|0.76|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||0.76|-0.91|
73979083|NCT00749944|147504048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.65|0.85|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.85|-0.65|
73979084|NCT00749944|147504049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.23|||||TWO_SIDED|95.0|-0.2|0.65|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.65|-0.20|
73979085|NCT00749944|147504049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.21|||||TWO_SIDED|95.0|-0.17|0.58|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||0.58|-0.17|
73979086|NCT00749944|147504049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.21|||||TWO_SIDED|95.0|-0.23|0.65|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.65|-0.23|
73979087|NCT00749944|147504049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.37|0.41|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||0.41|-0.37|
73979088|NCT00749944|147504049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-0.41|0.59|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||0.59|-0.41|
73979089|NCT00749944|147504049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.44|0.63|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||0.63|-0.44|
73979090|NCT00749944|147504049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.12|||||TWO_SIDED|95.0|-0.58|0.34|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.34|-0.58|
73979091|NCT00749944|147504050|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.22|||||TWO_SIDED|95.0|-0.66|1.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.10|-0.66|
73979092|NCT00749944|147504050|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.44|||||TWO_SIDED|95.0|-0.46|1.35|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.35|-0.46|
73979093|NCT00749944|147504050|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.22|||||TWO_SIDED|95.0|-1.16|0.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.71|-1.16|
74032873|NCT03521154|147618718|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.088|TWO_SIDED|95.0|0.35|1.08|||Log Rank||A hazard ratio \< 1 favours osimertinib|||1.08|0.35|0.088
73871713|NCT03223337|147286555|OTHER||Ratio of Geometric LS Mean|1.974|||||TWO_SIDED|90.0|1.5365|2.536|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5360|1.5365|
73871714|NCT03223337|147286555|OTHER||Ratio of Geometric LS Mean|1.4603|||||TWO_SIDED|90.0|0.9081|2.3484|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3484|0.9081|
73871715|NCT03223337|147286558|OTHER||Ratio of Geometric LS Mean|1.9973|||||TWO_SIDED|90.0|1.1061|3.6066|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.6066|1.1061|
73871716|NCT03223337|147286558|OTHER||Ratio of Geometric LS Mean|1.6509|||||TWO_SIDED|90.0|1.1285|2.415|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.4150|1.1285|
73871717|NCT03223337|147286558|OTHER||Ratio of Geometric LS Mean|1.6421|||||TWO_SIDED|90.0|1.0732|2.5125|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.5125|1.0732|
73871718|NCT03223337|147286558|OTHER||Ratio of Geometric LS Mean|1.5169|||||TWO_SIDED|90.0|1.0994|2.093|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.0930|1.0994|
73951499|NCT02404493|147436584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.231||0.518|TWO_SIDED|95.0|-0.635|0.331||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.331|-0.635|0.518
73951500|NCT02404493|147436585|SUPERIORITY_OR_OTHER|||||||0.005||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.005
73951501|NCT02404493|147436585|SUPERIORITY_OR_OTHER|||||||0.821||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.821
73871719|NCT03223337|147286558|OTHER||Ratio of Geometric LS Mean|1.624|||||TWO_SIDED|90.0|1.1599|2.2736|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.2736|1.1599|
73871720|NCT03223337|147286558|OTHER||Ratio of Geometric LS Mean|1.3143|||||TWO_SIDED|90.0|0.9887|1.747|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7470|0.9887|
73871721|NCT03223337|147286559|OTHER||Ratio of Geometric LS Mean|1.4566|||||TWO_SIDED|90.0|1.0344|2.0513|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.0513|1.0344|
73871722|NCT03223337|147286559|OTHER||Ratio of Geometric LS Mean|1.9478|||||TWO_SIDED|90.0|1.3935|2.7224|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7224|1.3935|
73871723|NCT03223337|147286559|OTHER||Ratio of Geometric LS Mean|1.8392|||||TWO_SIDED|90.0|1.335|2.534|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5340|1.3350|
73871724|NCT03223337|147286559|OTHER||Ratio of Geometric LS Mean|2.0161|||||TWO_SIDED|90.0|1.4711|2.763|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7630|1.4711|
73871725|NCT03223337|147286559|OTHER||Ratio of Geometric LS Mean|1.7303|||||TWO_SIDED|90.0|1.2932|2.3151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3151|1.2932|
73871726|NCT03223337|147286559|OTHER||Ratio of Geometric LS Mean|1.987|||||TWO_SIDED|90.0|1.5426|2.5594|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5594|1.5426|
73871727|NCT03223337|147286559|OTHER||Ratio of Geometric LS Mean|1.4646|||||TWO_SIDED|90.0|0.9086|2.3609|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3609|0.9086|
73871728|NCT03223337|147286560|OTHER||Ratio of Geometric LS Mean|1.9786|||||TWO_SIDED|90.0|1.0557|3.7084|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.7084|1.0557|
73871729|NCT03223337|147286560|OTHER||Ratio of Geometric LS Mean|1.2791|||||TWO_SIDED|90.0|0.9241|1.7705|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7705|0.9241|
73871730|NCT03223337|147286560|OTHER||Ratio of Geometric LS Mean|1.2487|||||TWO_SIDED|90.0|0.8675|1.7974|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7974|0.8675|
73871731|NCT03223337|147286560|OTHER||Ratio of Geometric LS Mean|1.1802|||||TWO_SIDED|90.0|0.9165|1.5197|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.5197|0.9165|
73871732|NCT03223337|147286560|OTHER||Ratio of Geometric LS Mean|1.2726|||||TWO_SIDED|90.0|0.952|1.7012|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7012|0.9520|
73951502|NCT02404493|147436585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.351||0.06|TWO_SIDED|95.0|-1.435|0.032||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.032|-1.435|0.060
73951503|NCT02404493|147436586|SUPERIORITY_OR_OTHER|||||||0.007||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.007
74032874|NCT06150573|147618766|SUPERIORITY||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.498||0.9141|TWO_SIDED|95.0|-1.04|0.93|||ANOVA|||||0.93|-1.04|0.9141
73871733|NCT03223337|147286560|OTHER||Ratio of Geometric LS Mean|1.0409|||||TWO_SIDED|90.0|0.7927|1.3668|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.3668|0.7927|
73979094|NCT00749944|147504050|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-0.68|0.73|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.73|-0.68|
73979095|NCT00749944|147504050|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.58|||||TWO_SIDED|95.0|-0.79|1.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||1.96|-0.79|
73979096|NCT00749944|147504050|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.69|0.82|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.82|-1.69|
73979097|NCT00749944|147504050|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.09|||||TWO_SIDED|95.0|-0.86|0.68|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.68|-0.86|
73979098|NCT00749944|147504051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.27|||||TWO_SIDED|95.0|-0.55|1.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.08|-0.55|
73979099|NCT00749944|147504051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.53|||||TWO_SIDED|95.0|-0.39|1.46|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.46|-0.39|
73979100|NCT00749944|147504051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-1.08|1.25|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||1.25|-1.08|
73979101|NCT00749944|147504051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.14|||||TWO_SIDED|95.0|-0.62|0.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.90|-0.62|
73979102|NCT00749944|147504051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-0.94|1.95|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||1.95|-0.94|
73979103|NCT00749944|147504051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.03|||||TWO_SIDED|95.0|-1.57|1.51|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||1.51|-1.57|
73979104|NCT00749944|147504051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.91|0.75|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.75|-0.91|
73979105|NCT00749944|147504052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.35|||||TWO_SIDED|95.0|-1.76|1.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.06|-1.76|
74032875|NCT06150573|147618767|SUPERIORITY||Adjusted Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.494||0.4583|TWO_SIDED|95.0|-0.61|1.34|||ANOVA|||||1.34|-0.61|0.4583
73979106|NCT00749944|147504052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.11|||||TWO_SIDED|95.0|-0.96|1.17|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.17|-0.96|
73979107|NCT00749944|147504052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.49|||||TWO_SIDED|95.0|-1.94|4.91|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||4.91|-1.94|
73979108|NCT00749944|147504052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-1.18|2.18|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||2.18|-1.18|
73979109|NCT00749944|147504052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.61|||||TWO_SIDED|95.0|-0.85|2.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||2.07|-0.85|
73979110|NCT00749944|147504052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|2.1|||||TWO_SIDED|95.0|-2.6|6.79|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||6.79|-2.60|
73979111|NCT00749944|147504052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.13|||||TWO_SIDED|95.0|-0.7|2.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||2.96|-0.70|
73979112|NCT00749944|147504053|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.0|||||TWO_SIDED|95.0|-0.26|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.27|-0.26|
74032876|NCT06150573|147618768|SUPERIORITY||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.061||0.0042|TWO_SIDED|95.0|-0.3|-0.06|||ANOVA|||Week 12||-0.06|-0.30|0.0042
74032877|NCT06150573|147618768|SUPERIORITY||Adjusted Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED|95.0|-0.46|-0.17|||ANOVA|||Week 24||-0.17|-0.46|<0.0001
73951504|NCT02404493|147436586|SUPERIORITY_OR_OTHER|||||||0.051||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.051
73951505|NCT02404493|147436586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.188||0.926|TWO_SIDED|95.0|-0.41|0.375||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.375|-0.410|0.926
73951506|NCT02404493|147436587|SUPERIORITY_OR_OTHER|||||||0.58||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.580
73951507|NCT02404493|147436587|SUPERIORITY_OR_OTHER|||||||0.363||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.363
73951508|NCT02404493|147436587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.539|TWO_SIDED|95.0|-0.531|0.286||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.286|-0.531|0.539
73951509|NCT02404493|147436588|SUPERIORITY_OR_OTHER|||||||0.055||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.055
73951510|NCT02404493|147436588|SUPERIORITY_OR_OTHER|||||||0.076||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.076
73951511|NCT02404493|147436588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.682|TWO_SIDED|95.0|-0.672|0.449||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.449|-0.672|0.682
73951512|NCT02404493|147436589|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
73951513|NCT02404493|147436589|SUPERIORITY_OR_OTHER|||||||0.025||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.025
73951514|NCT02404493|147436589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.991|TWO_SIDED|95.0|-0.509|0.514||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.514|-0.509|0.991
73951515|NCT02404493|147436590|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73951516|NCT02404493|147436590|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73951517|NCT02404493|147436590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.334|TWO_SIDED|95.0|-0.214|0.6||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.600|-0.214|0.334
73951518|NCT02404493|147436591|SUPERIORITY_OR_OTHER|||||||0.169||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.169
73951519|NCT02404493|147436591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.317|TWO_SIDED|95.0|-0.778|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.278|-0.778|0.317
73951520|NCT02404493|147436592|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
74032878|NCT06150573|147618769|SUPERIORITY||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.016||0.2478|TWO_SIDED|95.0|-0.05|0.01|||ANOVA|||Mean Gingival MLSI, Week 12||0.01|-0.05|0.2478
74032879|NCT06150573|147618769|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.0957|TWO_SIDED|95.0|-0.07|0.01|||ANOVA|||Mean Gingival MLSI, Week 24||0.01|-0.07|0.0957
74032880|NCT06150573|147618769|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.122||0.0063|TWO_SIDED|95.0|-0.58|-0.1|||ANOVA|||Mean Interproximal MLSI, Week 12||-0.10|-0.58|0.0063
74032881|NCT06150573|147618769|SUPERIORITY||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.147|<|0.0001|TWO_SIDED|95.0|-0.89|-0.31|||ANOVA|||Mean Interproximal MLSI, Week 24||-0.31|-0.89|<0.0001
74032882|NCT06150573|147618769|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.1536|TWO_SIDED|95.0|-0.03|0.01|||ANOVA|||Mean Body MLSI, Week 12||0.01|-0.03|0.1536
73871734|NCT03223337|147286561|OTHER||Ratio of Geometric LS Mean|1.0097|||||TWO_SIDED|90.0|0.7122|1.4316|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4316|0.7122|
73871735|NCT03223337|147286561|OTHER||Ratio of Geometric LS Mean|1.7852|||||TWO_SIDED|90.0|1.2498|2.5498|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5498|1.2498|
73871736|NCT03223337|147286561|OTHER||Ratio of Geometric LS Mean|1.7337|||||TWO_SIDED|90.0|1.2343|2.4353|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.4353|1.2343|
73871737|NCT03223337|147286561|OTHER||Ratio of Geometric LS Mean|1.7628|||||TWO_SIDED|90.0|1.2898|2.4092|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.4092|1.2898|
73871738|NCT03223337|147286561|OTHER||Ratio of Geometric LS Mean|1.6413|||||TWO_SIDED|90.0|1.2055|2.2347|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.2347|1.2055|
73871739|NCT03223337|147286561|OTHER||Ratio of Geometric LS Mean|1.8289|||||TWO_SIDED|90.0|1.3992|2.3904|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3904|1.3992|
73871740|NCT03223337|147286561|OTHER||Ratio of Geometric LS Mean|1.3367|||||TWO_SIDED|90.0|0.8288|2.1557|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.1557|0.8288|
73871741|NCT03223337|147286562|OTHER||Ratio of Geometric LS Mean|0.905|||||TWO_SIDED|90.0|0.69|1.1869|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.1869|0.6900|
73979113|NCT00749944|147504053|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.25|0.29|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.29|-0.25|
73871742|NCT03223337|147286562|OTHER||Ratio of Geometric LS Mean|0.7415|||||TWO_SIDED|90.0|0.5617|0.9787|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||0.9787|0.5617|
73871743|NCT03223337|147286562|OTHER||Ratio of Geometric LS Mean|0.7299|||||TWO_SIDED|90.0|0.4387|1.2145|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.2145|0.4387|
73871744|NCT03223337|147286562|OTHER||Ratio of Geometric LS Mean|1.1703|||||TWO_SIDED|90.0|0.9|1.5219|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.5219|0.9000|
73871745|NCT03223337|147286562|OTHER||Ratio of Geometric LS Mean|0.9585|||||TWO_SIDED|90.0|0.6664|1.3786|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.3786|0.6664|
73871746|NCT03223337|147286562|OTHER||Ratio of Geometric LS Mean|1.0004|||||TWO_SIDED|90.0|0.7833|1.2778|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.2778|0.7833|
73871747|NCT03223337|147286563|OTHER||Ratio of Geometric LS Mean|1.0574|||||TWO_SIDED|90.0|0.7876|1.4197|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4197|0.7876|
73871748|NCT03223337|147286563|OTHER||Ratio of Geometric LS Mean|1.0143|||||TWO_SIDED|90.0|0.7332|1.4032|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4032|0.7332|
73871749|NCT03223337|147286563|OTHER||Ratio of Geometric LS Mean|1.038|||||TWO_SIDED|90.0|0.7695|1.4002|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4002|0.7695|
73871750|NCT03223337|147286563|OTHER||Ratio of Geometric LS Mean|1.3427|||||TWO_SIDED|90.0|0.7635|2.3615|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3615|0.7635|
73871751|NCT03223337|147286563|OTHER||Ratio of Geometric LS Mean|1.0296|||||TWO_SIDED|90.0|0.6996|1.5151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.5151|0.6996|
73871752|NCT03223337|147286563|OTHER||Ratio of Geometric LS Mean|1.2721|||||TWO_SIDED|90.0|0.8409|1.9245|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.9245|0.8409|
73871753|NCT03223337|147286563|OTHER||Ratio of Geometric LS Mean|1.2072|||||TWO_SIDED|90.0|0.9398|1.5508|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.5508|0.9398|
73871754|NCT03223337|147286564|OTHER||Median Difference (Final Values)|0.0||||0.6822|TWO_SIDED|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||0.50|-1.00|0.6822
73871755|NCT03223337|147286564|OTHER||Median Difference (Final Values)|0.0||||0.5767|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.5767
73871756|NCT03223337|147286564|OTHER||Median Difference (Final Values)|0.0||||0.588|TWO_SIDED|90.0|-1.0|1.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.50|-1.00|0.5880
73979114|NCT00749944|147504053|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.37|0.58|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.58|-0.37|
73951521|NCT02404493|147436592|SUPERIORITY_OR_OTHER|||||||0.182||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.182
73951522|NCT02404493|147436592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.027|TWO_SIDED|95.0|-0.931|-0.069||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.069|-0.931|0.027
73951523|NCT02404493|147436593|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73951524|NCT02404493|147436593|SUPERIORITY_OR_OTHER|||||||0.08||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.080
73951525|NCT02404493|147436593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.699|TWO_SIDED|95.0|-0.824|0.574||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.574|-0.824|0.699
73951526|NCT02404493|147436594|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73951527|NCT02404493|147436594|SUPERIORITY_OR_OTHER|||||||0.058||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.058
73951528|NCT02404493|147436594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.33||0.711|TWO_SIDED|95.0|-0.607|0.857||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.857|-0.607|0.711
73951529|NCT02404493|147436595|SUPERIORITY_OR_OTHER|||||||0.006||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.006
73979115|NCT00749944|147504053|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-0.17|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.34|-0.17|
73979116|NCT00749944|147504053|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.04|||||TWO_SIDED|95.0|-0.4|0.48|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.48|-0.40|
73979117|NCT00749944|147504053|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.17|||||TWO_SIDED|95.0|-0.44|0.78|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.78|-0.44|
73871757|NCT03223337|147286564|OTHER||Median Difference (Final Values)|0.0||||0.7716|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.7716
74032883|NCT06150573|147618769|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.006||0.1166|TWO_SIDED|95.0|-0.02|0.0|||ANOVA|||Mean Body MLSI, Week 24||0.00|-0.02|0.1166
73951530|NCT02404493|147436595|SUPERIORITY_OR_OTHER|||||||0.012||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.012
73951531|NCT02404493|147436595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.194||0.932|TWO_SIDED|95.0|-0.391|0.424||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.424|-0.391|0.932
73951532|NCT02404493|147436596|SUPERIORITY_OR_OTHER|||||||0.003||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.003
73951533|NCT02404493|147436596|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73951534|NCT02404493|147436596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.228||0.767|TWO_SIDED|95.0|-0.41|0.547||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.547|-0.410|0.767
73979118|NCT00749944|147504053|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.13|||||TWO_SIDED|95.0|-0.14|0.4|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.40|-0.14|
74032884|NCT06150573|147618770|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.21|-0.07|||ANOVA|||Week 12||-0.07|-0.21|<0.0001
74032885|NCT06150573|147618770|SUPERIORITY||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|-0.25|-0.1|||ANOVA|||Week 24||-0.10|-0.25|<0.0001
73951535|NCT02404493|147436597|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73951536|NCT02404493|147436597|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
73951537|NCT02404493|147436597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.242||0.571|TWO_SIDED|95.0|-0.65|0.37||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.370|-0.650|0.571
73951538|NCT00050089|147436697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.165||||0.69|TWO_SIDED|95.0|0.856|1.585|||Log Rank||The comparison was Mega-ART (intensification) vs Standard-ART (standard).|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.||1.585|0.856|0.69
73979119|NCT00749944|147504056|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.41|||||TWO_SIDED|95.0|-1.09|1.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.90|-1.09|
73979120|NCT00749944|147504056|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-1.54|1.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.71|-1.54|
73979121|NCT00749944|147504056|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.06|||||TWO_SIDED|95.0|-2.47|2.6|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||2.60|-2.47|
73979122|NCT00749944|147504056|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.29|||||TWO_SIDED|95.0|-1.57|2.15|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||2.15|-1.57|
73979123|NCT00749944|147504056|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.94|||||TWO_SIDED|95.0|-2.23|0.36|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.36|-2.23|
73979124|NCT00749944|147504056|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.74|||||TWO_SIDED|95.0|-2.81|1.33|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||1.33|-2.81|
73979125|NCT00749944|147504056|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.78|0.92|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.92|-1.78|
74032886|NCT06150573|147618771|SUPERIORITY||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.04|TWO_SIDED|95.0|-0.13|0.0|||ANOVA|||Week 12||-0.00|-0.13|0.0400
73951539|NCT00050089|147436698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.49|TWO_SIDED|95.0|0.674|1.275|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation)|Time-to-event (Kaplan-Meier) and stratified log-rank analysis was performed.||1.275|0.674|0.49
73951540|NCT00050089|147436699|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Log Rank|||Stratified Log-rank test was used to compare the four treatment||||0.87
73979126|NCT00749944|147504057|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-0.04|0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.19|-0.04|
73979127|NCT00749944|147504057|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.08|-0.11|
73979128|NCT00749944|147504057|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.06|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.09|-0.06|
74032887|NCT06150573|147618771|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.037||0.001|TWO_SIDED|95.0|-0.2|-0.05|||ANOVA|||Week 24||-0.05|-0.20|0.0010
73951541|NCT00050089|147436700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008||||0.92|TWO_SIDED|95.0|0.75|1.35|||Log Rank||The comparison was Standard-ART (standard) vs Mega-ART (intensification)|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison||1.35|0.75|0.92
73951542|NCT00050089|147436701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.68|TWO_SIDED|95.0|0.8|1.46|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation) of ART|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.||1.46|0.8|0.68
73951543|NCT04039503|147436704|SUPERIORITY||LS Mean Difference|-1.66|||<|0.001|TWO_SIDED|95.0|-1.88|-1.43|||Mixed Models Analysis|||||-1.43|-1.88|<0.001
73951544|NCT04039503|147436704|SUPERIORITY||LS Mean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-1.88|-1.43|||Mixed Models Analysis|||||-1.43|-1.88|<0.001
73951545|NCT04039503|147436705|SUPERIORITY||LS Mean Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.52|-1.07|||Mixed Models Analysis|||||-1.07|-1.52|<0.001
73951546|NCT04039503|147436706|SUPERIORITY||LS Mean Difference|-7.8|||<|0.001|TWO_SIDED|95.0|-9.4|-6.3|||Mixed Models Analysis|||||-6.3|-9.4|<0.001
73951547|NCT04039503|147436706|SUPERIORITY||LS Mean Difference|-9.9|||<|0.001|TWO_SIDED|95.0|-11.5|-8.3|||Mixed Models Analysis|||||-8.3|-11.5|<0.001
73951548|NCT04039503|147436706|SUPERIORITY||LS Mean Difference|-12.6|||<|0.001|TWO_SIDED|95.0|-14.2|-11.0|||Mixed Models Analysis|||||-11.0|-14.2|<0.001
73951549|NCT04039503|147436707|SUPERIORITY||Odds Ratio (OR)|37.77|||<|0.001|TWO_SIDED|95.0|15.23|93.7|||Regression, Logistic|||||93.70|15.23|<0.001
73951550|NCT04039503|147436707|SUPERIORITY||Odds Ratio (OR)|100.07|||<|0.001|TWO_SIDED|95.0|30.02|333.62|||Regression, Logistic|||||333.62|30.02|<0.001
73979129|NCT00749944|147504057|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.02|-0.11|
73979130|NCT00749944|147504057|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.14|||||TWO_SIDED|95.0|-0.27|-0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||-0.01|-0.27|
73979131|NCT00749944|147504057|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.1|||||TWO_SIDED|95.0|-0.21|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.01|-0.21|
73871758|NCT03223337|147286564|OTHER||Median Difference (Final Values)|0.5||||0.4093|TWO_SIDED|90.0|-1.0|2.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.00|-1.00|0.4093
73951551|NCT04039503|147436707|SUPERIORITY||Odds Ratio (OR)|43.31|||<|0.001|TWO_SIDED|95.0|16.92|110.83|||Regression, Logistic|||||110.83|16.92|<0.001
73871759|NCT03223337|147286564|OTHER||Median Difference (Final Values)|0.0||||0.9837|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.9837
73951552|NCT04039503|147436708|SUPERIORITY||LS Mean Difference|-22.5|||<|0.001|TWO_SIDED|95.0|-29.5|-15.4|||Mixed Models Analysis|||||-15.4|-29.5|<0.001
73951553|NCT04039503|147436708|SUPERIORITY||LS Mean Difference|-29.0|||<|0.001|TWO_SIDED|95.0|-36.0|-22.0|||Mixed Models Analysis|||||-22.0|-36.0|<0.001
73951554|NCT04039503|147436708|SUPERIORITY||LS Mean Difference|-28.8|||<|0.001|TWO_SIDED|95.0|-35.9|-21.6|||Mixed Models Analysis|||||-21.6|-35.9|<0.001
73951555|NCT04039503|147436710|SUPERIORITY||Odds Ratio (OR)|17.15|||<|0.001|TWO_SIDED|95.0|7.55|38.93|||Regression, Logistic|||||38.93|7.55|<0.001
73951556|NCT04039503|147436710|SUPERIORITY||Odds Ratio (OR)|27.24|||<|0.001|TWO_SIDED|95.0|11.87|62.55|||Regression, Logistic|||||62.55|11.87|<0.001
73951557|NCT04039503|147436710|SUPERIORITY||Odds Ratio (OR)|79.61|||<|0.001|TWO_SIDED|95.0|32.76|193.44|||Regression, Logistic|||||193.44|32.76|<0.001
73951558|NCT04039503|147436711|SUPERIORITY||Estimate Difference|-35.4|||||TWO_SIDED|95.0|-46.0|-22.8||||||||-22.8|-46.0|
73951559|NCT04039503|147436711|SUPERIORITY||Estimate Difference|-38.2|||||TWO_SIDED|95.0|-48.3|-26.1||||||||-26.1|-48.3|
73951560|NCT04039503|147436711|SUPERIORITY||Estimate Difference|-49.3|||||TWO_SIDED|95.0|-57.7|-39.4||||||||-39.4|-57.7|
73951561|NCT04039503|147436714|SUPERIORITY||Odds Ratio (OR)|12.22|||<|0.001|TWO_SIDED|95.0|3.93|38.0|||Regression, Logistic|||||38.00|3.93|<0.001
73951562|NCT04039503|147436714|SUPERIORITY||Odds Ratio (OR)|32.36|||<|0.001|TWO_SIDED|95.0|10.52|99.49|||Regression, Logistic|||||99.49|10.52|<0.001
73951563|NCT04039503|147436714|SUPERIORITY||Odds Ratio (OR)|56.26|||<|0.001|TWO_SIDED|95.0|18.27|173.26|||Regression, Logistic|||||173.26|18.27|<0.001
73951564|NCT01216293|147436715|SUPERIORITY_OR_OTHER_LEGACY||Difference|19.2|||||TWO_SIDED|95.0|7.0|30.2|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||30.2|7.0|
73951565|NCT01216293|147436715|SUPERIORITY_OR_OTHER_LEGACY||Difference|18.2|||||TWO_SIDED|95.0|6.7|30.4|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||30.4|6.7|
73979132|NCT00749944|147504057|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.1|||||TWO_SIDED|95.0|-0.17|-0.03|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||-0.03|-0.17|
73951566|NCT01216293|147436716|SUPERIORITY_OR_OTHER_LEGACY||Difference|27.366|||||TWO_SIDED|95.0|12.749|42.957|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||42.957|12.749|
73951567|NCT01216293|147436716|SUPERIORITY_OR_OTHER_LEGACY||Difference|22.025|||||TWO_SIDED|95.0|8.357|35.714|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||35.714|8.357|
73951568|NCT01216293|147436717|SUPERIORITY_OR_OTHER_LEGACY||Difference|20.1|||||TWO_SIDED|95.0|4.0|34.4|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||34.4|4.0|
73951569|NCT01216293|147436717|SUPERIORITY_OR_OTHER_LEGACY||Difference|11.6|||||TWO_SIDED|95.0|-2.7|28.3|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||28.3|-2.7|
73951570|NCT01216293|147436718|SUPERIORITY_OR_OTHER_LEGACY||Difference|6.83|||||TWO_SIDED|95.0|0.4|12.78|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||12.78|0.40|
73951571|NCT01216293|147436718|SUPERIORITY_OR_OTHER_LEGACY||Difference|7.23|||||TWO_SIDED|95.0|0.59|12.86|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||12.86|0.59|
73951572|NCT01671748|147436736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.565|TWO_SIDED|95.0|-33.4|18.6||ANCOVA was used to analyse differences between the NLFU+SOC and SOC arms of the primary endpoint, percentage change in wound area from baseline (week 5) to final visit (week 13). Patients' baseline (week 5) wound area was used as the covariate.|ANCOVA|||The study was powered to detect a difference in the change in wound area of 20% between the two arms with a two sided significance level and power of 90%. A standard deviation of 17.5% came from published literature. A minimum of 17 patients in each arm was required.||18.6|-33.4|0.565
73951573|NCT01671748|147436737|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||ANCOVA|||ANCOVA was used for change in HRQoL from week 1 to week 13 (with week 1 HRQoL score as the covariate).||||0.490
73951574|NCT01671748|147436738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.08||||0.078|TWO_SIDED|95.0|-19.23|1.06|||ANCOVA|||ANCOVA was used for change in pain score (VAS) from week 5 to week 13 (covariate was baseline pain score).||1.06|-19.23|0.078
73951575|NCT01671748|147436739|SUPERIORITY_OR_OTHER|||||||0.346|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change in number of infections were not normally distributed and differences between the arms were tested using the non-parametric Mann-Whitney U test.||||0.346
73951576|NCT01671748|147436741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.618|TWO_SIDED|95.0|-4.7|2.9|||ANCOVA|Patients' baseline (week 5) wound area was used as the covariate.||||2.9|-4.7|0.618
73979133|NCT00749944|147504058|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.03|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.12|-0.03|
73979134|NCT00749944|147504058|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.0|||||TWO_SIDED|95.0|-0.08|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.09|-0.08|
73871760|NCT03223337|147286565|OTHER||Median Difference (Final Values)|0.0||||0.6224|TWO_SIDED|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||0.50|-1.00|0.6224
73951577|NCT04834362|147436749|OTHER|||||||0.677|||||||t-test, 2 sided|||||||0.677
73951578|NCT04834362|147436750|OTHER|||||||0.053|||||||t-test, 2 sided|||||||0.053
73951579|NCT04834362|147436751|OTHER|||||||0.918|||||||t-test, 2 sided|||||||0.918
73951580|NCT04834362|147436752|OTHER|||||||0.729|||||||Chi-squared|||||||0.729
73951581|NCT02555371|147436761|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.004|TWO_SIDED|95.0|0.45|0.86|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||0.86|0.45|0.004
73951582|NCT02555371|147436762|SUPERIORITY||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 12 has been presented.|||0.24|0.15|<0.001
73951583|NCT02555371|147436762|SUPERIORITY||Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.12|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 24 has been presented.|||0.20|0.12|<0.001
73951584|NCT02555371|147436762|SUPERIORITY||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 36 has been presented.|||0.24|0.15|<0.001
73951585|NCT02555371|147436762|SUPERIORITY||Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.13|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 52 has been presented.|||0.20|0.13|<0.001
73951586|NCT02555371|147436763|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.005|TWO_SIDED|95.0|0.49|0.88|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||0.88|0.49|0.005
73951587|NCT02555371|147436764|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.57|TWO_SIDED|95.0|0.5|3.51|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||3.51|0.50|0.570
73979135|NCT00749944|147504058|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-0.04|0.11|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.11|-0.04|
73979136|NCT00749944|147504058|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.08|0.05|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.05|-0.08|
73871761|NCT03223337|147286565|OTHER||Median Difference (Final Values)|0.0||||0.8042|TWO_SIDED|90.0|-1.0|0.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||0.00|-1.00|0.8042
73871762|NCT03223337|147286565|OTHER||Median Difference (Final Values)|0.0||||0.8423|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.8423
73951588|NCT03615482|147436784|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-0.9||||0.617|TWO_SIDED|95.0|-4.5|2.7|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Erythema||2.7|-4.5|0.617
73951589|NCT03615482|147436784|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.6||||0.32|TWO_SIDED|95.0|-7.8|2.6|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Pain||2.6|-7.8|0.320
73979137|NCT00749944|147504058|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.22|0.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.06|-0.22|
73979138|NCT00749944|147504058|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.03|||||TWO_SIDED|95.0|-0.14|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.09|-0.14|
73979139|NCT00749944|147504058|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.02|-0.11|
73979140|NCT00749944|147504059|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.06|||||TWO_SIDED|95.0|-0.2|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.09|-0.20|
73979141|NCT00749944|147504059|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.15|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.12|-0.15|
73979142|NCT00749944|147504059|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.15|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.04|-0.15|
73979143|NCT00749944|147504059|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.2|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.04|-0.20|
73979144|NCT00749944|147504059|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.17|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.27|-0.17|
74032888|NCT00069095|147618772|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|97.5|0.94|1.18||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.18|0.94|
73951590|NCT03615482|147436784|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.1||||0.31|TWO_SIDED|95.0|-6.2|2.0|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Swelling||2.0|-6.2|0.310
73951591|NCT03615482|147436785|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.2||||0.205|TWO_SIDED|95.0|-5.8|1.2|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Arthralgia||1.2|-5.8|0.205
73979145|NCT00749944|147504059|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.21|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|-0.21|
73979146|NCT00749944|147504059|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.17|0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.07|-0.17|
73979147|NCT00749944|147504060|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.3|||||TWO_SIDED|95.0|-0.58|-0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||-0.02|-0.58|
73979148|NCT00749944|147504060|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.44|||||TWO_SIDED|95.0|-0.69|-0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||-0.19|-0.69|
73951592|NCT03615482|147436785|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.9||||0.273|TWO_SIDED|95.0|-8.0|2.3|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Fatigue||2.3|-8.0|0.273
73951593|NCT03615482|147436785|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.2||||0.372|TWO_SIDED|95.0|-6.9|2.6|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Headache||2.6|-6.9|0.372
73951594|NCT03615482|147436785|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|2.4||||0.329|TWO_SIDED|95.0|-2.4|7.1|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Myalgia||7.1|-2.4|0.329
73951595|NCT03615482|147436786|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.6|0.6||||||||0.6|-0.6|
73951596|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.66||||0.004|TWO_SIDED|95.0|0.54|0.82|||cLDA|GMT ratio, 95% CI and p-value were estimated from a constrained longitudinal data analysis (cLDA) model including all vaccinated participants.||Serotype 1||0.82|0.54|0.004
73871763|NCT03223337|147286565|OTHER||Median Difference (Final Values)|0.0||||0.5207|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.5207
74032889|NCT00069095|147618773|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.22|||||TWO_SIDED|97.5|1.05|1.42||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.42|1.05|
74032890|NCT00069095|147618774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|97.5|0.58|0.83|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.83|0.58|<0.0001
73951597|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.81|1.09|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 3||1.09|0.81|<0.001
74032891|NCT00069095|147618775|NON_INFERIORITY_OR_EQUIVALENCE|Fewer events were expected in the 'on-treatment analysis', thus leading to reduced power. No formal statistical testing was therefore applied.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|97.5|1.07|1.44||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.44|1.07|
74032892|NCT00069095|147618776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|97.5|0.52|0.75|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.75|0.52|<0.0001
73871764|NCT03223337|147286565|OTHER||Median Difference (Final Values)|0.0||||0.8423|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.8423
73871765|NCT03223337|147286565|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|1.0000
73951598|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.69|1.01|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 4||1.01|0.69|<0.001
73951599|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.64|0.98|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 5||0.98|0.64|<0.001
73951600|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.71|1.0|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 6A||1.00|0.71|<0.001
73951601|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.74|1.04|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 6B||1.04|0.74|<0.001
74039484|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|-2.21|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.43|-2.21|0.0035
73871766|NCT03223337|147286565|OTHER||Median Difference (Final Values)|0.0||||0.8042|TWO_SIDED|90.0|0.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|0.00|0.8042
73871767|NCT01362608|147286584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.69|||<|0.0001|TWO_SIDED|95.0|-28.2|-11.2|||ANCOVA|||||-11.2|-28.2|<0.0001
73871768|NCT01362608|147286585|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.0043|TWO_SIDED|95.0|0.1|0.71|||Regression, Cox|||||0.71|0.10|0.0043
73871769|NCT01336140|147286603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Chi-squared|||"We calculated that a minimum of 248 subjects are needed to attain 80% power to detect 70% reduction in the incidence of the primary endpoint (diarrhea), assuming an event rate of 15% in the control group (2-tailed α = 0.05). We targeted enrolling 300 patients to allow some room for error in our assumptions.~null hypothesis: incidence of diarrhea is no different between the aminophylline arm and the placebo arm."||||0.002
73871770|NCT01336140|147286604|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
73871771|NCT01336140|147286605|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
73871772|NCT01336140|147286606|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Chi-squared|||||||1
73871773|NCT03526146|147286619|SUPERIORITY|||||||0.002|||||||paired t-test|||||||0.002
73871774|NCT03526146|147286620|SUPERIORITY|||||||0.047|||||||paired t-test|||||||0.047
73871775|NCT03526146|147286621|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
73871776|NCT03526146|147286622|SUPERIORITY|||||||0.05|||||||paired t-test|||||||0.05
73871777|NCT03526146|147286623|SUPERIORITY|||||||0.009|||||||paired t-test|||||||0.009
73871778|NCT01013194|147286669|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||Fisher Exact|||||||0.4340
73871779|NCT01013194|147286670|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||t-test, 2 sided|||Comparison at 1 year Follow-up||||0.0076
73871780|NCT01013194|147286671|SUPERIORITY_OR_OTHER|||||||0.0437|TWO_SIDED||||||t-test, 2 sided|||Comparison at 1 year Follow-up||||0.0437
73871781|NCT03329092|147286693|OTHER||Difference in clinical cure rate|2.7|||||TWO_SIDED|95.0|-6.6|12.4|||||The confidence interval (CI) for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.4|-6.6|
73871782|NCT03329092|147286694|OTHER||Difference in clinical cure rate|2.7|||||TWO_SIDED|95.0|-7.0|13.2|||||The CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||13.2|-7.0|
73951602|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.75|0.99|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 7F||0.99|0.75|<0.001
73951603|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.86|1.15|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 9V||1.15|0.86|<0.001
73951604|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.91|||<|0.001|TWO_SIDED|95.0|0.77|1.08|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 14||1.08|0.77|<0.001
73951605|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.68|0.92|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 18C||0.92|0.68|<0.001
73951606|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.73|0.95|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 19A||0.95|0.73|<0.001
73871783|NCT03329092|147286695|OTHER||Difference in clinical cure rate|0.5|||||TWO_SIDED|95.0|-10.2|12.1|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.1|-10.2|
73871784|NCT03329092|147286696|OTHER||Difference in clinical cure rate|2.6|||||TWO_SIDED|95.0|-8.4|14.7|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||14.7|-8.4|
73871785|NCT03329092|147286697|OTHER||Difference in clinical cure rate|2.4|||||TWO_SIDED|95.0|-7.4|13.0|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||13.0|-7.4|
73871786|NCT03329092|147286697|OTHER||Difference in clinical cure rate|4.3|||||TWO_SIDED|95.0|-15.5|23.1|||Difference||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||23.1|-15.5|
73871787|NCT03329092|147286698|OTHER||Difference in clinical cure rate|5.6|||||TWO_SIDED|95.0|-4.0|16.6|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||16.6|-4.0|
73871788|NCT03329092|147286698|OTHER||Difference in clinical cure rate|-7.9|||||TWO_SIDED|95.0|-31.9|17.3|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||17.3|-31.9|
73871789|NCT03329092|147286725|OTHER||Difference in clinical cure rate|2.3|||||TWO_SIDED|95.0|-6.2|11.5|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||11.5|-6.2|
73871790|NCT03329092|147286726|OTHER||Difference in clinical cure|-1.2|||||TWO_SIDED|95.0|-10.7|9.4|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||9.4|-10.7|
73871791|NCT03329092|147286727|OTHER||Difference in clinical cure|0.3|||||TWO_SIDED|95.0|-8.3|9.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||9.9|-8.3|
73871792|NCT03329092|147286728|OTHER||Difference in clinical cure rate|1.0|||||TWO_SIDED|95.0|-8.5|12.0|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.0|-8.5|
73871793|NCT03329092|147286729|OTHER||Difference in clinical cure rate|1.9|||||TWO_SIDED|95.0|-6.9|11.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||11.9|-6.9|
73871794|NCT03329092|147286729|OTHER||Difference in clinical cure rate|3.9|||||TWO_SIDED|95.0|-15.2|23.4|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||23.4|-15.2|
73871795|NCT03329092|147286730|OTHER||Difference in clinical cure rate|3.1|||||TWO_SIDED|95.0|-5.2|13.2|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||13.2|-5.2|
73871796|NCT03329092|147286730|OTHER||Difference in clinical cure rate|-10.4|||||TWO_SIDED|95.0|-32.6|14.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||14.9|-32.6|
73871797|NCT02588261|147286790|SUPERIORITY||Hazard Ratio (HR)|1.611||||0.992|TWO_SIDED|95.0|1.086|2.391|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.391|1.086|0.992
73871798|NCT02588261|147286792|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.||||1.000
73951607|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 19F||1.17|0.89|<0.001
73951608|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.64|0.91|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 22F||0.91|0.64|<0.001
73951609|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.7|1.03|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 23F||1.03|0.70|<0.001
73979149|NCT00749944|147504060|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.14|||||TWO_SIDED|95.0|-0.47|0.2|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.20|-0.47|
73979150|NCT00749944|147504060|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.35|||||TWO_SIDED|95.0|-0.61|-0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||-0.09|-0.61|
73979151|NCT00749944|147504060|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.45|||||TWO_SIDED|95.0|-0.83|-0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||-0.07|-0.83|
74032893|NCT00069095|147618777|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|97.5|0.92|1.15||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.15|0.92|
73871799|NCT02588261|147286793|SUPERIORITY||Hazard Ratio (HR)|1.674||||0.998|TWO_SIDED|95.0|1.165|2.406|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.406|1.165|0.998
73871800|NCT02588261|147286794|SUPERIORITY|||||||0.839|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.||||0.839
73871801|NCT02588261|147286795|SUPERIORITY||Hazard Ratio (HR)|1.298||||0.78|TWO_SIDED|95.0|0.661|2.548|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.548|0.661|0.780
73951610|NCT03615482|147436787|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.72|0.96|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 33F||0.96|0.72|<0.001
73979152|NCT00749944|147504060|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.08|||||TWO_SIDED|95.0|-0.5|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.34|-0.50|
73979153|NCT00749944|147504060|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.27|||||TWO_SIDED|95.0|-0.57|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.02|-0.57|
73951611|NCT03615482|147436788|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.25|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||H1N1||1.25|0.94|<0.001
73951612|NCT03615482|147436788|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||H3N2||1.17|0.90|<0.001
73951613|NCT03615482|147436788|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.86|1.08|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||B-Victoria||1.08|0.86|<0.001
73951614|NCT03615482|147436788|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.9|1.13|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||B-Yamagata||1.13|0.90|<0.001
73951615|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.89||||||Serotype 1||0.89|0.67|
73871802|NCT02287467|147286813|SUPERIORITY||Odds Ratio (OR)|1.25||||0.33|TWO_SIDED|95.0|0.79|1.97|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is hIVIG vs. placebo. A value greater than 1 favors the hIVIG group.|Odds ratio of being in a better category, as assessed using a proportional odds model. Multiple imputation techniques were used to impute an outcome for 4 patients for whom the outcome was unknown.||1.97|0.79|.33
73871803|NCT02287467|147286814|SUPERIORITY||Odds Ratio (OR)|0.95||||0.84|TWO_SIDED|95.0|0.61|1.48|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs placebo. An odds ratio greater than 1 favors the hIVIG group.|Odds ratio for being in a better category, from a proportional odds model||1.48|0.61|.84
73951616|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|0.99||||||Serotype 3||0.99|0.76|
73951617|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.68|0.91||||||Serotype 4||0.91|0.68|
73951618|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||Serotype 5||1.02|0.77|
73979154|NCT00749944|147504061|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.08|-0.12|
73979155|NCT00749944|147504061|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.08|-0.12|
73979156|NCT00749944|147504061|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.04|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.14|-0.04|
73951619|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.87||||||Serotype 6A||0.87|0.61|
73951620|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.64|0.91||||||Serotype 6B||0.91|0.64|
73951621|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.01||||||Serotype 7F||1.01|0.76|
73951622|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03||||||Serotype 9V||1.03|0.79|
73951623|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||Serotype 14||0.99|0.73|
73871804|NCT02287467|147286815|SUPERIORITY||Odds Ratio (OR)|0.87||||0.52|TWO_SIDED|95.0|0.57|1.33|||Regression, Cox|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs. placebo. An odds ratio \> 1 favors the hIVIG group.|Odds ratio for being in a better group, from a proportional odds model.||1.33|0.57|.52
73871805|NCT02287467|147286816|SUPERIORITY||Odds Ratio (OR)|1.49||||0.2|TWO_SIDED|95.0|0.81|2.74|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio for hIVIG vs placebo. An odds ratio \> 1.0 favors the hIVIG group.|||2.74|0.81|.20
73951624|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.91||||||Serotype 18C||0.91|0.68|
73951625|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.02||||||Serotype 19A||1.02|0.78|
73951626|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.03||||||Serotype 19F||1.03|0.77|
73951627|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 22F||0.89|0.65|
73951628|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 23F||0.98|0.70|
73951629|NCT03615482|147436789|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|0.99||||||Serotype 33F||0.99|0.75|
73951630|NCT01500226|147436807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|1.2|<0.001
73979157|NCT00749944|147504061|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.07|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.04|-0.07|
73951631|NCT01500226|147436808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.143|TWO_SIDED|95.0|0.9|1.6||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||1.6|0.9|0.143
73951632|NCT01500226|147436809|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.0||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|1.3|<0.001
73951633|NCT03699124|147436847|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|0.936|||||TWO_SIDED|95.0|0.816|1.073||||||||1.073|0.816|
73979158|NCT00749944|147504061|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.15|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.13|-0.15|
73979159|NCT00749944|147504061|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.06|||||TWO_SIDED|95.0|0.01|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|0.01|
73979160|NCT00749944|147504061|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.08|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.04|-0.08|
73979161|NCT00749944|147504062|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.12|||||TWO_SIDED|95.0|-0.05|0.28|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.28|-0.05|
73979162|NCT00749944|147504062|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.19|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.14|-0.19|
73979163|NCT00749944|147504062|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.04|||||TWO_SIDED|95.0|-0.29|0.22|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.22|-0.29|
73979164|NCT00749944|147504062|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.04|||||TWO_SIDED|95.0|-0.2|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.13|-0.20|
73979165|NCT00749944|147504062|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.19|||||TWO_SIDED|95.0|-0.4|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.01|-0.40|
73979166|NCT00749944|147504062|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.16|||||TWO_SIDED|95.0|-0.42|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|-0.42|
73951634|NCT03699124|147436847|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|1.115|||||TWO_SIDED|95.0|0.967|1.287||||||||1.287|0.967|
73951635|NCT03699124|147436847|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|1.044|||||TWO_SIDED|95.0|0.915|1.191||||||||1.191|0.915|
73979167|NCT00749944|147504062|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.07|||||TWO_SIDED|95.0|-0.22|8.0|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||008|-0.22|
73979168|NCT00749944|147504063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.6|3.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.3|0.6|
73979169|NCT00749944|147504063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.7|0.4|
73979170|NCT00749944|147504063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.1|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.1|0.4|
73979171|NCT00749944|147504063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.2|0.4|
73951636|NCT01474512|147436860|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951637|NCT01474512|147436860|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951638|NCT01474512|147436861|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951639|NCT01474512|147436861|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951640|NCT01474512|147436862|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.||||||<0.001
73951641|NCT01474512|147436862|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.||||||<0.001
73951642|NCT01474512|147436863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951643|NCT01474512|147436863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951644|NCT01474512|147436863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.||||||<0.001
73951645|NCT01474512|147436863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.||||||<0.001
73951646|NCT01474512|147436864|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.||||||<0.001
73951647|NCT01474512|147436864|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.||||||<0.001
73951648|NCT01474512|147436865|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951649|NCT01474512|147436865|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951650|NCT01474512|147436866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73951651|NCT01474512|147436866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73951652|NCT01474512|147436867|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73951653|NCT01474512|147436867|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73951654|NCT01474512|147436868|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73951655|NCT01474512|147436868|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73951656|NCT01474512|147436869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73951657|NCT01474512|147436869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73979172|NCT00749944|147504063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
73979173|NCT00749944|147504063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
73951658|NCT01474512|147436870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for Absenteeism.||||||<0.001
73951659|NCT01474512|147436870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for absenteeism.||||||0.003
73951660|NCT01474512|147436870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.||||||<0.001
73951661|NCT01474512|147436870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.||||||<0.001
73951662|NCT01474512|147436870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.||||||<0.001
73951663|NCT01474512|147436870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.||||||<0.001
73951664|NCT01474512|147436870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.||||||<0.001
73951665|NCT01474512|147436870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.||||||<0.001
73951666|NCT01474512|147436871|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA|||||||<0.001
73951667|NCT01474512|147436871|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA|||||||<0.001
73951668|NCT01474512|147436872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.||||||<0.001
73951669|NCT01474512|147436872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.||||||<0.001
73951670|NCT01474512|147436872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.||||||<0.001
73951671|NCT01474512|147436872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.||||||<0.001
73951672|NCT01474512|147436873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73951673|NCT01474512|147436873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73951674|NCT01474512|147436874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951675|NCT01474512|147436874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951676|NCT01474512|147436874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951677|NCT01474512|147436874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951678|NCT01474512|147436874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI100|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951679|NCT01474512|147436874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value if for PPASI100.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
73951680|NCT05454449|147436925|OTHER|||||||0.047|||||||t-test, 2 sided|||||||0.047
73951681|NCT05454449|147436926|OTHER|||||||0.009|||||||t-test, 2 sided|||||||0.009
73951682|NCT05454449|147436927|OTHER|||||||0.082|||||||t-test, 2 sided|||||||0.082
73951683|NCT05454449|147436928|OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
73871806|NCT02287467|147286817|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.44|TWO_SIDED|95.0|0.85|1.45|||Regression, Cox|Stratified by baseline clinical status, region, and participation in the pilot study.|hazard ratio is hIVIG vs placebo; a hazard ratio \>1 favors the hIVIG group.|Deaths during hospitalization are censored after day 7.||1.45|.85|.44
73871807|NCT02287467|147286818|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.4|TWO_SIDED|95.0|0.48|6.15|||Regression, Cox|stratified by baseline clinical status, region, and participation in pilot study|hazard ratio is for hIVIG vs placebo; a hazard ratio \< 1.0 favors the hIVIG group.|||6.15|.48|.40
73871808|NCT02287467|147286819|SUPERIORITY||Odds Ratio (OR)|0.87||||0.74|TWO_SIDED|95.0|0.38|1.98|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo; an odds ratio \> 1.0 favors hIVIG|||1.98|.38|.74
73871809|NCT02287467|147286820|SUPERIORITY||Mean Difference (Net)|0.14||||0.49|TWO_SIDED|95.0|-0.26|0.54|||Regression, Linear|Adjusted for baseline RNA, geographic region, and influenza subtype|Change is calculated as day 3 - baseline. Difference in changes is hIVIG - placebo.|||.54|-.26|.49
73871810|NCT02287467|147286821|SUPERIORITY||Odds Ratio (OR)|0.97||||0.93|TWO_SIDED|95.0|0.5|1.97|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study.|Odds ratio is for hIVIG vs placebo.|||1.97|0.5|.93
73871811|NCT02287467|147286822|SUPERIORITY||Odds Ratio (OR)|0.92||||0.81|TWO_SIDED|95.0|0.5|1.82|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG group vs placebo|||1.82|0.5|.81
73871812|NCT02287467|147286823|SUPERIORITY||Odds Ratio (OR)|1.17||||0.55|TWO_SIDED|95.0|0.7|1.95|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study|Odds ratio (hIVIG vs placebo) of being in a better category. An odds ratio \> 1 favors the hIVIG group.|Proportional odds for being in a better category||1.95|0.70|.55
73871813|NCT02287467|147286824|SUPERIORITY||Odds Ratio (OR)|1.12||||0.77|TWO_SIDED|95.0|0.5|2.31|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo|||2.31|.5|.77
73951684|NCT05454449|147436929|OTHER|||||||0.016|||||||t-test, 2 sided|||||||0.016
73951685|NCT05454449|147436930|OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
73951686|NCT05454449|147436931|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
73979174|NCT00749944|147504063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
73871814|NCT02287467|147286825|SUPERIORITY||Odds Ratio (OR)|1.32||||0.34|TWO_SIDED|95.0|0.7|2.34|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is expressed as hIVIG vs placebo|||2.34|0.7|.34
73871815|NCT02287467|147286826|SUPERIORITY||Odds Ratio (OR)|0.9||||0.73|TWO_SIDED|95.0|0.5|1.62||adjusted for baseline clinical status, region, and participation in pilot study|Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio (hIVIG vs placebo) is for being in a better category. An odds ratio \>1 favors the hIVIG group.|||1.62|.50|.73
73871816|NCT02287467|147286827|SUPERIORITY||Odds Ratio (OR)|0.94||||0.82|TWO_SIDED|95.0|0.55|1.59|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio (hIVIG vs placebo) is for being in a better category.|Multiple imputation was used to estimate the outcome for 3 participants for whom the outcome was partially unknown.||1.59|0.55|.82
73871817|NCT02287467|147286828|SUPERIORITY||Odds Ratio (OR)|3.19||||0.02|TWO_SIDED|95.0|1.21|8.42|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|Odds ratio (hIVIG vs placebo) for a better outcome. An odds ratio \> 1 favors the hIVIG group.|Multiple imputation was used to estimate the outcome for one participant.||8.42|1.21|.02
73871818|NCT02287467|147286829|SUPERIORITY||ratio of geometric means|1.5||||0.18|TWO_SIDED|95.0|0.84|2.7|||Mixed Models Analysis|longitudinal regression with adjustment for baseline titer|Ratio of hIVIG group to placebo group. A ratio \> 1.0 indicates higher titers for the hIVIG group.|HAI measurements were log-transformed to compute treatment differences and the model was adjusted for baseline titer.||2.7|0.84|.18
73871819|NCT02287467|147286830|SUPERIORITY||ratio of geometric means|1.31||||0.13|TWO_SIDED|95.0|0.93|1.8|||Mixed Models Analysis|longitudinal analysis of log-transformed titers adjust for baseline titer.|Ratio of geometric means of hIVIG vs placebo. A ratio \>1.0 indicates higher titers in the hIVIG group on day 7.|||1.8|0.93|.13
73951687|NCT03249376|147436951|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-6.34|-2.83|||Mixed Effects Model for Repeated Measure|||||-2.83|-6.34|<0.0001
73951688|NCT03249376|147436952|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.37|-0.51|||Mixed Effects Model for Repeated Measure|||||-0.51|-1.37|<0.0001
73951689|NCT03249376|147436953|SUPERIORITY||Least Squares Mean Difference|4.6||||0.005|TWO_SIDED|95.0|1.42|7.69|||ANCOVA|||||7.69|1.42|0.005
73951690|NCT01154036|147436954|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-12.7|||<|0.001|TWO_SIDED|95.0|-16.6|-8.7||The primary hypotheses were tested at 0.045, applying Hochberg's procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-8.7|-16.6|<0.001
73951691|NCT01154036|147436954|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimate|-9.1|||<|0.001|TWO_SIDED|95.0|-12.9|-5.4||The primary hypotheses were tested at 0.045, applying Hochberg's procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.4|-12.9|<0.001
73979175|NCT00749944|147504064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|0.6|10.4|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||10.4|0.6|
73951692|NCT01154036|147436955|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.5|||<|0.001|TWO_SIDED|95.0|-15.9|-5.1||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.1|-15.9|<0.001
73951693|NCT01154036|147436955|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.5|||<|0.001|TWO_SIDED|95.0|-13.6|-5.5||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.5|-13.6|<0.001
73951694|NCT01154036|147436956|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.62|3.89|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||3.89|1.62|<0.001
73951695|NCT01154036|147436956|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||0.007|TWO_SIDED|95.0|1.17|2.67|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||2.67|1.17|0.007
73951696|NCT01154036|147436957|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|1.55|4.73|||Logistic regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||4.73|1.55|<0.001
73951697|NCT01154036|147436957|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.38|||<|0.001|TWO_SIDED|95.0|1.56|3.63|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||3.63|1.56|<0.001
73951698|NCT01154036|147436958|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.46|||<|0.001|TWO_SIDED|95.0|4.56|19.62|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||19.62|4.56|<0.001
73951699|NCT01154036|147436958|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.23|6.82|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||6.82|2.23|<0.001
73951700|NCT01154036|147436959|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|27.77||||0.001|TWO_SIDED|95.0|3.64|211.83|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||211.83|3.64|0.001
73951701|NCT01154036|147436959|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|7.08|||<|0.001|TWO_SIDED|95.0|2.85|17.56|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||17.56|2.85|<0.001
73951702|NCT01154036|147436960|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.1|||<|0.001|TWO_SIDED|95.0|-9.7|-4.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.4|-9.7|<0.001
73979176|NCT00749944|147504064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.7|11.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||11.8|0.7|
73951703|NCT01154036|147436960|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.8|||<|0.001|TWO_SIDED|95.0|-8.3|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.3|-8.3|<0.001
73951704|NCT01154036|147436961|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.8|||<|0.001|TWO_SIDED|95.0|-10.7|-3.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.0|-10.7|<0.001
73951705|NCT01154036|147436961|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.4|||<|0.001|TWO_SIDED|95.0|-10.2|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.5|-10.2|<0.001
73951706|NCT01154036|147436962|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-2.1||||0.466|TWO_SIDED|95.0|-7.8|3.5|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||3.5|-7.8|0.466
73951707|NCT01154036|147436962|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-4.9||||0.081|TWO_SIDED|95.0|-10.3|0.5|||Constrained Longitudinal Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||0.5|-10.3|0.081
73951708|NCT01154036|147436963|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-2.8||||0.466|TWO_SIDED|95.0|-10.2|4.7|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||4.7|-10.2|0.466
73951709|NCT01154036|147436963|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squarres Means|-7.1||||0.011|TWO_SIDED|95.0|-12.6|-1.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||-1.6|-12.6|0.011
73951710|NCT01154036|147436964|SUPERIORITY_OR_OTHER_LEGACY||Difference in M--estimates|1.7||||0.133|TWO_SIDED|95.0|-0.5|4.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||4.0|-0.5|0.133
73979177|NCT00749944|147504064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.9|0.5|
73979178|NCT00749944|147504064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.4|7.8|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||7.8|0.4|
73871820|NCT02287467|147286831|SUPERIORITY||ratio of geometric means|0.94||||0.78|TWO_SIDED|95.0|0.58|1.5|||Mixed Models Analysis|log-transformed titers adjusted for baseline titer|ratio of geometric mean for hIVIG vs placebo. A ratio \> 1.0 indicates higher titers at day 7 for the hIVIG group.|||1.5|0.58|.78
73951711|NCT01154036|147436964|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.6||||0.61|TWO_SIDED|95.0|-2.7|1.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.6|-2.7|0.610
73951712|NCT01154036|147436965|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-1.0||||0.52|TWO_SIDED|95.0|-4.2|2.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||2.1|-4.2|0.520
73951713|NCT01154036|147436965|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.7||||0.567|TWO_SIDED|95.0|-3.1|1.7|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.7|-3.1|0.567
73979179|NCT00749944|147504064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2|||||TWO_SIDED|95.0|0.5|9.2|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||9.2|0.5|
73979180|NCT00749944|147504064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.4|3.2|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.2|0.4|
73979181|NCT00749944|147504065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.9|0.5|
73979182|NCT00749944|147504065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|0.7|5.3|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.3|0.7|
73979183|NCT00749944|147504065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.7|4.4|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||4.4|0.7|
73979184|NCT00749944|147504065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.5|5.0|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.0|0.5|
73979185|NCT00749944|147504065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||||TWO_SIDED|95.0|0.8|6.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||6.8|0.8|
73979186|NCT00749944|147504065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.8|5.3|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.3|0.8|
73979187|NCT00749944|147504066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.5|4.9|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||4.9|0.5|
73979188|NCT00749944|147504066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.0|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.0|0.4|
73979189|NCT00749944|147504066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.8|0.4|
73979190|NCT00749944|147504066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.6|0.4|
73979191|NCT00749944|147504066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.6|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.6|0.3|
73979192|NCT00749944|147504066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.8|0.4|
73979193|NCT00749944|147504066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.7|0.4|
73979194|NCT00749944|147504067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.3|2.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.3|0.3|
73979195|NCT00749944|147504067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|1.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.9|0.4|
73979196|NCT00749944|147504067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.2|0.4|
73951714|NCT01154036|147436966|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.3||||0.003|TWO_SIDED|95.0|-8.8|-1.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.8|-8.8|0.003
73951715|NCT01154036|147436966|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.3||||0.011|TWO_SIDED|95.0|-7.7|-1.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.0|-7.7|0.011
73951716|NCT01154036|147436967|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.3||||0.079|TWO_SIDED|95.0|-9.2|0.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||0.5|-9.2|0.079
73951717|NCT01154036|147436967|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.7|||<|0.001|TWO_SIDED|95.0|-11.4|-4.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.1|-11.4|<0.001
73951718|NCT01154036|147436968|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|1.6||||0.156|TWO_SIDED|95.0|-0.6|3.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||3.8|-0.6|0.156
73951719|NCT01154036|147436968|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.9||||0.425|TWO_SIDED|95.0|-2.9|1.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.2|-2.9|0.425
73951720|NCT01154036|147436969|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|0.5||||0.739|TWO_SIDED|95.0|-2.5|3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||3.6|-2.5|0.739
73951721|NCT01154036|147436969|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-1.0||||0.41|TWO_SIDED|95.0|-3.3|1.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.3|-3.3|0.410
73951722|NCT01154036|147436970|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.1|||<|0.001|TWO_SIDED|95.0|-13.6|-6.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.6|-13.6|<0.001
73951723|NCT01154036|147436970|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.6|||<|0.001|TWO_SIDED|95.0|-10.9|-4.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.3|-10.9|<0.001
73951724|NCT01154036|147436971|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.3|||<|0.001|TWO_SIDED|95.0|-14.0|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.5|-14.0|<0.001
73951725|NCT01154036|147436971|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.8||||0.001|TWO_SIDED|95.0|-13.5|-6.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.2|-13.5|0.001
73951726|NCT01154036|147436972|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.1|||<|0.001|TWO_SIDED|95.0|-11.2|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.9|-11.2|<0.001
73951727|NCT01154036|147436972|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.8||||0.001|TWO_SIDED|95.0|-7.8|-1.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.9|-7.8|0.001
73951728|NCT01154036|147436973|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.9|||<|0.001|TWO_SIDED|95.0|-11.0|-2.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.8|-11.0|<0.001
73951729|NCT01154036|147436973|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.4|||<|0.001|TWO_SIDED|95.0|-9.4|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.3|-9.4|<0.001
73951730|NCT01154036|147436974|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-13.7|||<|0.001|TWO_SIDED|95.0|-18.1|-9.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-9.3|-18.1|<0.001
73951731|NCT01154036|147436974|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.8|||<|0.001|TWO_SIDED|95.0|-11.9|-3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.6|-11.9|<0.001
73951732|NCT01154036|147436975|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.4|||<|0.001|TWO_SIDED|95.0|-15.8|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.9|-15.8|<0.001
73951733|NCT01154036|147436975|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.3|||<|0.001|TWO_SIDED|95.0|-12.5|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.2|-12.5|<0.001
73951734|NCT01154036|147436976|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.3|||<|0.001|TWO_SIDED|95.0|-10.0|-2.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.5|-10.0|<0.001
73951735|NCT01154036|147436976|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-3.5||||0.052|TWO_SIDED|95.0|-7.1|0.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||0.0|-7.1|0.052
73979197|NCT00749944|147504067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.5|2.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.6|0.5|
73979198|NCT00749944|147504067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.5|2.3|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.3|0.5|
73979199|NCT00749944|147504067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.6|2.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.7|0.6|
73979200|NCT00749944|147504067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.5|2.8|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.8|0.5|
73979201|NCT00749944|147504069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.6|0.0|
73979202|NCT00749944|147504069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.6|0.0|
73979203|NCT00749944|147504069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.6|0.3|
73979204|NCT00749944|147504069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.7|0.0|
74032894|NCT00069095|147618778|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0015|TWO_SIDED|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.95|0.72|0.0015
73871821|NCT00108862|147286839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|3.0||0.45|TWO_SIDED|95.08|-2.0|8.0||The analysis was stratified by screening CD4 (\<50 cells/mm3 vs =\>50). Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided|A 2-sided Z-test was used to compare the two percents. The test was weighted by the inverse of the Greenwood's variance in each CD4 stratum.|The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|Assuming that immediate ART was better than deferred ART and that the combined rate in the deferred ART arm was 25% compared to 15% in the immediate ART arm (a 40% reduction), and assuming 10% loss to follow-up in a two-sided, two-sample 0.05-level asymptotically-normal test with 400 participants in each arm, there was 90% power. The percents tested were Kaplan-Meier estimators at week 48 with the associated Greenwood's variance.||8|-2|0.45
73979205|NCT00749944|147504069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.7|0.0|
73979206|NCT00749944|147504069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.7|0.3|
73979207|NCT00749944|147504070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.2|23.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||23.6|0.2|
73979208|NCT03775915|147504074|OTHER||||||>|0.05||||||p-value calculated for interaction between group and day|Linear Mixed Model|Linear mixed effects model adjusted for baseline, F(2,46) = 1.061, p \>0.05||||||>0.05
73979209|NCT03775915|147504075|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73979210|NCT00923078|147504108|OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.02|<|0.05|TWO_SIDED|95.0|0.17|4.23|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||4.23|0.17|<0.05
73979211|NCT00923078|147504108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|1.02||0.48|TWO_SIDED|95.0|-2.75|1.31|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.31|-2.75|0.48
74032895|NCT00069095|147618779|NON_INFERIORITY_OR_EQUIVALENCE|This study was not powered for testing non-inferiority of XELOX vs FOLFOX-4 with respect to overall survival and no margin could be derived following the effect retention concept. The same margins used for the PFS analysis \[Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin)\] were therefore applied to OS as well.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|97.5|0.84|1.14||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.14|0.84|
73951736|NCT01154036|147436977|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.8||||0.024|TWO_SIDED|95.0|-10.8|-0.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-0.8|-10.8|0.024
73951737|NCT01154036|147436977|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.1||||0.002|TWO_SIDED|95.0|-9.9|-2.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.3|-9.9|0.002
73951738|NCT01154036|147436978|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.6|||<|0.001|TWO_SIDED|95.0|-14.9|-6.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.4|-14.9|<0.001
73951739|NCT01154036|147436978|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.2||||0.002|TWO_SIDED|95.0|-10.2|-2.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.2|-10.2|0.002
73951740|NCT01154036|147436979|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.3|||<|0.001|TWO_SIDED|95.0|-14.8|-3.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.9|-14.8|<0.001
73951741|NCT01154036|147436979|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.4|||<|0.001|TWO_SIDED|95.0|-12.6|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.2|-12.6|<0.001
73951742|NCT01154036|147436980|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-3.9||||0.613|TWO_SIDED|95.0|-18.9|11.1|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||11.1|-18.9|0.613
73951743|NCT01154036|147436980|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-1.5||||0.831|TWO_SIDED|95.0|-15.7|12.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||12.6|-15.7|0.831
73951744|NCT01154036|147436981|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-13.1||||0.187|TWO_SIDED|95.0|-32.6|6.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||6.4|-32.6|0.187
73951745|NCT01154036|147436981|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-11.6||||0.153|TWO_SIDED|95.0|-27.7|4.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||4.4|-27.7|0.153
73979212|NCT00923078|147504108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|1.02|<|0.01|TWO_SIDED|95.0|-4.95|-0.9|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.90|-4.95|<0.01
74032896|NCT00069095|147618780|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1921|TWO_SIDED|97.5|0.72|1.09|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented together with the 97.5% confidence interval.||1.09|0.72|0.1921
73951746|NCT00906503|147436982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|STANDARD_DEVIATION|1.6|||TWO_SIDED|95.0|0.06|31.1||||||||31.1|0.06|
73951747|NCT01558674|147437070|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-98.5|||||TWO_SIDED|95.0|-138.0|-59.1|||Linear mixed effect model||8-mg MK-7145 LS Mean minus Furosemide LS Mean|||-59.1|-138.0|
73951748|NCT01558674|147437072|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|1.1|||||TWO_SIDED|90.0|0.99|1.22|||Mixed Linear Effects Model||GMR = Geometric mean (GM) MK-7145 8 mg divided by GM Furosemide|||1.22|0.99|
73951749|NCT04147260|147437084|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|90.0|-0.03|0.2|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.20|-0.03|
73979213|NCT00923078|147504109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|0.295|<|0.05|TWO_SIDED|95.0|0.08|1.25|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.25|0.08|<0.05
73951750|NCT04147260|147437084|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|90.0|-0.07|0.16|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.16|-0.07|
73951751|NCT04147260|147437084|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.055||0.572|TWO_SIDED|90.0|-0.14|0.08||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.08|-0.14|0.572
73871822|NCT00108862|147286840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.0||0.02|TWO_SIDED|95.08|2.0|21.0||Interim reviews employed group sequential monitoring using an\> O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.||21|2|0.02
73871823|NCT00108862|147286841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|3.0||0.67|TWO_SIDED|95.08|-7.0|4.0||Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.||4|-7|0.67
73871824|NCT00684775|147286878|SUPERIORITY||Odds Ratio (OR)|6.0|||=|0.002|TWO_SIDED|95.0|1.44|25.0|||General Estimating Equation (GEE)|||||25.0|1.44|=0.002
73951752|NCT04147260|147437084|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.075||0.315|TWO_SIDED|90.0|-0.07|0.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.23|-0.07|0.315
73951753|NCT04147260|147437084|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.059||0.286|TWO_SIDED|90.0|-0.18|0.05||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.05|-0.18|0.286
73979214|NCT00923078|147504109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.295||0.09|TWO_SIDED|95.0|-0.08|1.09|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.09|-0.08|0.09
73979215|NCT00923078|147504109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.295||0.59|TWO_SIDED|95.0|-0.75|0.43|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.43|-0.75|0.59
73979216|NCT00923078|147504110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.03|STANDARD_ERROR_OF_MEAN|0.75|<|0.01|TWO_SIDED|95.0|-3.53|-0.52||Post-test scores following Auditory Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.52|-3.53|<0.01
73979217|NCT00923078|147504110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.45|STANDARD_ERROR_OF_MEAN|0.75||0.01|TWO_SIDED|95.0|-3.95|-0.94||Post-test scores following Visual Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.94|-3.95|0.01
74032897|NCT00069095|147618781|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0023|TWO_SIDED|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.95|0.72|0.0023
74032898|NCT00069095|147618782|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.89|||||TWO_SIDED|97.5|0.72|1.09||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \> 0.66, where OR denotes Odds ratio.||1.09|0.72|
73871825|NCT00684775|147286879|SUPERIORITY|||||||0.0081|||||||t-test, 2 sided|||||||0.0081
73871826|NCT00684775|147286880|SUPERIORITY||Odds Ratio (OR)|1.34||||0.56|TWO_SIDED|95.0|0.5|3.6|||General Estimating Equation (GEE)|||||3.6|.5|0.56
73871827|NCT00684775|147286881|SUPERIORITY||Odds Ratio (OR)|1.45|||=|0.41|TWO_SIDED|95.0|0.6|3.53|||General Estimating Equation (GEE)|||||3.53|.6|=0.41
73871828|NCT00684775|147286882|SUPERIORITY||Odds Ratio (OR)|1.19||||0.75|TWO_SIDED|95.0|0.42|3.36|||General Estimating Equation (GEE)|||||3.36|.42|0.75
73871829|NCT00684775|147286883|SUPERIORITY|||||||0.1543|||||||t-test, 2 sided|||||||0.1543
73871830|NCT00684775|147286884|SUPERIORITY||Odds Ratio (OR)|1.82||||0.15|TWO_SIDED|95.0|0.81|4.1|||General Estimating Equation (GEE)|||||4.1|.81|0.15
73871831|NCT00632619|147286891|SUPERIORITY_OR_OTHER|||||||0.106|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.106
73871832|NCT00632619|147286892|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline which was week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.015
73871833|NCT00632619|147286893|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was conducted to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.38
73951754|NCT04147260|147437084|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.077||0.057|TWO_SIDED|90.0|0.0|0.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.31|0.00|0.057
73951755|NCT04147260|147437085|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|90.0|-0.02|0.49|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.49|-0.02|
73951756|NCT04147260|147437085|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|90.0|-0.2|0.22|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.22|-0.20|
73951757|NCT04147260|147437085|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|90.0|-0.72|-0.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-0.31|-0.72|<0.001
73979218|NCT00923078|147504110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.75||0.58|TWO_SIDED|95.0|-1.93|1.08||Post-test scores following Auditory Cognitive Training as compared to Visual Cognitive Training, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.08|-1.93|0.58
73979219|NCT00923078|147504111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|1.55||0.06|TWO_SIDED|95.0|-6.02|0.18|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.18|-6.02|0.06
73979220|NCT00923078|147504111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.24|STANDARD_ERROR_OF_MEAN|1.55|<|0.05|TWO_SIDED|95.0|-6.34|-0.14|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.14|-6.34|< 0.05
73871834|NCT00632619|147286894|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.016
73871835|NCT00632619|147286895|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.095
73951758|NCT04147260|147437085|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|90.0|0.24|0.8||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.80|0.24|<0.001
73951759|NCT04147260|147437085|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.132||0.01|TWO_SIDED|90.0|-0.62|-0.09||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-0.09|-0.62|0.010
73951760|NCT04147260|147437085|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.173||0.001|TWO_SIDED|90.0|0.24|0.93||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.93|0.24|0.001
73951761|NCT04147260|147437086|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.044|||TWO_SIDED|90.0|-0.05|0.1|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.10|-0.05|
73951762|NCT04147260|147437086|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.038||0.998|TWO_SIDED|90.0|-0.08|0.08||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.08|-0.08|0.998
73951763|NCT04147260|147437086|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.618|TWO_SIDED|90.0|-0.08|0.13||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.13|-0.08|0.618
73951764|NCT04147260|147437086|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.099|||TWO_SIDED|90.0|-0.1|0.23|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.23|-0.10|
73951765|NCT04147260|147437086|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.081||0.451|TWO_SIDED|90.0|-0.1|0.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.23|-0.10|0.451
73979221|NCT00923078|147504111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.55||0.84|TWO_SIDED|95.0|-3.42|2.78|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.78|-3.42|0.84
73979222|NCT00923078|147504112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|1.04||0.55|TWO_SIDED|95.0|-1.45|2.69|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.69|-1.45|0.55
73979223|NCT00923078|147504112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|1.03||0.98|TWO_SIDED|95.0|-2.02|2.07|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.07|-2.02|0.98
73979224|NCT00923078|147504112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.04||0.57|TWO_SIDED|95.0|-2.66|1.47|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.47|-2.66|0.57
74032899|NCT00069095|147618783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.3091|TWO_SIDED|97.5|0.71|1.14|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%.||1.14|0.71|0.3091
73951766|NCT04147260|147437086|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.11||1|TWO_SIDED|90.0|-0.22|0.22||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.22|-0.22|1.000
73951767|NCT04147260|147437087|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|90.0|-0.15|0.36|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.36|-0.15|
73951768|NCT04147260|147437087|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.131||0.446|TWO_SIDED|90.0|-0.16|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.16|0.446
73871836|NCT00566852|147286896|SUPERIORITY_OR_OTHER|||||||0.059||||||Significance level was 0.025.|Wilcoxon (Mann-Whitney)|||Null hypothesis: patients on memantine will experience less decline than patients receiving placebo. Based on a one-sided Wilcoxon rank sum test with alpha=0.025, 221 patients per arm would be required to have 80% statistical power to detect a mean difference of 0.87 in the HVLT-R change scores between the two treatment arms. Assuming that 20% of patients may be ineligible, or die prior to the 24 week assessment, the target sample size for randomization was set to 536.||||0.059
73871837|NCT00566852|147286897|SUPERIORITY|||||||0.0692||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||8 weeks||||0.0692
73871838|NCT00566852|147286897|SUPERIORITY|||||||0.4541||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||16 weeks||||0.4541
73951769|NCT04147260|147437087|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.172||0.972|TWO_SIDED|90.0|-0.34|0.35||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.35|-0.34|0.972
73951770|NCT04147260|147437087|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|90.0|-0.02|0.6|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.60|-0.02|
73951771|NCT04147260|147437087|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.15||0.091|TWO_SIDED|90.0|-0.04|0.56||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.56|-0.04|0.091
73951772|NCT04147260|147437087|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.203||0.88|TWO_SIDED|90.0|-0.38|0.44||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.44|-0.38|0.880
73951773|NCT04147260|147437088|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.043|||TWO_SIDED|90.0|-0.15|-0.01|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||-0.01|-0.15|
73979225|NCT00923078|147504113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|1.27||0.63|TWO_SIDED|95.0|-3.14|1.93|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.93|-3.14|0.63
73979226|NCT00923078|147504113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|1.27||0.47|TWO_SIDED|95.0|-3.45|1.61|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.61|-3.45|0.47
74032900|NCT00069095|147618784|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab shall be concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.94|||||TWO_SIDED|97.5|0.76|1.16||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \> 0.66||1.16|0.76|
74032901|NCT00069095|147618785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9887|TWO_SIDED|97.5|0.78|1.28|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX 4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%||1.28|0.78|0.9887
73871839|NCT00566852|147286897|SUPERIORITY|||||||0.397||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||52 weeks||||0.3970
73951774|NCT04147260|147437088|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.757|TWO_SIDED|90.0|-0.09|0.06||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.06|-0.09|0.757
73951775|NCT04147260|147437088|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.049||0.158|TWO_SIDED|90.0|-0.17|0.03||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.03|-0.17|0.158
73951776|NCT04147260|147437088|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.101|||TWO_SIDED|90.0|-0.12|0.22|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.22|-0.12|
73871840|NCT00566852|147286898|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.01|TWO_SIDED|95.0|0.62|0.99|||Gray's test|||A one-sided log-rank test with alpha 0.025 accruing 221 patients/arm with 12 months of follow-up would ensure 98% statistical power to detect a 33% relative reduction in the monthly hazard rate with the use of memantine. Gray's test was used to test for a statistically significant difference in the distribution of neurocognitive failure times and Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||0.99|0.62|0.01
73979227|NCT00923078|147504113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.27||0.8|TWO_SIDED|95.0|-2.85|2.22|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.22|-2.85|0.80
73979228|NCT00923078|147504114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.98||0.26|TWO_SIDED|95.0|-3.06|0.85|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.85|-3.06|0.26
73979229|NCT00923078|147504114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.47|STANDARD_ERROR_OF_MEAN|0.97||0.13|TWO_SIDED|95.0|-3.41|0.46|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.46|-3.41|0.13
74032902|NCT00069095|147618786|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was done.|Hazard Ratio (HR)|1.08|||||TWO_SIDED|97.5|0.97|1.2||||||General approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)||1.20|0.97|
74032903|NCT00069095|147618786|NON_INFERIORITY_OR_EQUIVALENCE|Fewer events were expected in analyses using the on-treatment approach than in the analyses using the general approach, thus leading to reduced power.Therefore, no formal statistical testing was performed.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|97.5|0.98|1.23||||||On-treatment Approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.23|0.98|
74032904|NCT00069095|147618787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.003|TWO_SIDED|97.5|0.74|0.96|||Log Rank|||General approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.96|0.74|0.0030
74032905|NCT00069095|147618787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0004|TWO_SIDED|97.5|0.7|0.92|||Log Rank|||On treatment approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.92|0.70|0.0004
74032906|NCT00069095|147618790|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was performed for duration of overall response.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|97.5|0.86|1.22||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)||1.22|0.86|
74032907|NCT00069095|147618791|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0307|TWO_SIDED|97.5|0.66|1.01|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||1.01|0.66|0.0307
74032908|NCT00069095|147618792|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was done.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|97.5|0.09|1.39||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.39|0.09|
74032909|NCT00069095|147618793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.8207|TWO_SIDED|97.5|0.2|7.05|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||7.05|0.20|0.8207
74032910|NCT02439281|147618819|OTHER|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||||||0.4510
74032911|NCT02439281|147618820|OTHER|||||||0.8914|||||||Wilcoxon (Mann-Whitney)|||||||0.8914
74032912|NCT02439281|147618823|OTHER|||||||0.9531|||||||Wilcoxon (Mann-Whitney)|||||||0.9531
74032913|NCT02439281|147618824|OTHER|||||||0.778|||||||Wilcoxon (Mann-Whitney)|||||||0.7780
74032914|NCT02439281|147618825|OTHER|||||||0.5692|||||||Wilcoxon (Mann-Whitney)|||||||0.5692
74032915|NCT00358917|147618826|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (once daily \[QD\] minus twice daily \[BID\], based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|Diff. in Percentage of Subj. Responding|3.5||||0.413||95.0|-4.5|11.5|||normal approx. to binomial distribution|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 participants (300 participants in each of the QD and BID treatment regimens) provided 83% power (with a type I error rate of 0.05) to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||11.5|-4.5|0.413
73979230|NCT00923078|147504114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.98||0.71|TWO_SIDED|95.0|-2.32|1.58|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.58|-2.32|0.71
73979231|NCT02336958|147504128|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
73979232|NCT02336958|147504129|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED||||||t-test, 2 sided|||||||0.459
73979233|NCT02037568|147504180|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||.96
73979234|NCT02037568|147504181|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
73979235|NCT02037568|147504182|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
73979236|NCT02037568|147504183|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
73979237|NCT02037568|147504184|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.070
73979238|NCT02037568|147504185|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
73979239|NCT02037568|147504186|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
74032916|NCT00358917|147618827|SUPERIORITY_OR_OTHER||Diff. in Percentage of Subj. Responding|3.8||||0.389||95.0|-4.3|11.9|||normal approx. to binomial distribution|||||11.9|-4.3|0.389
74032917|NCT00358917|147618828|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||ANOVA|||||||0.281
74032918|NCT00358917|147618830|SUPERIORITY_OR_OTHER|||||||0.222||95.0|||||Fisher Exact|||||||0.222
73979240|NCT02037568|147504187|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
73979241|NCT02037568|147504188|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
73979242|NCT02684136|147504189|SUPERIORITY||||||<|0.05|||||||ANCOVA|baseline used as covariate||||||<0.05
73979243|NCT02684136|147504190|SUPERIORITY||||||<|0.05||||||baseline used as covariate|ANCOVA|||||||<0.05
73979244|NCT00721734|147504193|SUPERIORITY_OR_OTHER||Slope|-0.607||||0.4114|TWO_SIDED|95.0|-2.129|0.914|||Regression, Linear|||"In order to estimate a possible effect of renal function, the relationship between the clearance of carfilzomib and creatinine clearance (CrCl) was explored using a mixed-effects model that included CrCl.~The slope of the regression of CL as a function of CrCL at Cycle 1, Day 1 was evaluated using a linear regression model that included CrCL as continuous variables (excluding the hemodialysis group)."||0.914|-2.129|0.4114
73979245|NCT00621842|147504214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.01|TWO_SIDED|95.0|-18.0|-12.9|||t-test, 2 sided|df=53||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||-12.9|-18.0|<.01
73979246|NCT00621842|147504216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2|||<|0.01|TWO_SIDED|95.0|-17.5|-12.9|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||-12.9|-17.5|<.01
73979247|NCT00621842|147504217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.49|TWO_SIDED|95.0|-1.82|0.88|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||.88|-1.82|.49
73979248|NCT00621842|147504218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.01|TWO_SIDED|95.0|-2.43|-1.68|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||-1.68|-2.43|<.01
73979249|NCT00621842|147504219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8|TWO_SIDED|95.0|-0.36|0.28|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||.28|-.36|.80
73979250|NCT00621842|147504220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.36||95.0|-0.97|2.62|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||2.62|-.97|.36
73979251|NCT00621842|147504222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.08|TWO_SIDED|95.0|-1.67|0.09|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||.09|-1.67|.08
73979252|NCT00621842|147504223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.04||95.0|-1.03|-0.04|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||-.04|-1.03|.04
73979253|NCT04604652|147504236|OTHER||||||=|0.077|||||||t-test, 1 sided|||A t-test was performed to test for the percent change from baseline to Week 12. This analysis was based on observed data without imputation. Testing was one sided using a 5% alpha level. No multiplicity adjustment was used, and the p-values reported for the endpoints were descriptive in nature.||||=0.077
73979254|NCT03692871|147504253|OTHER||Difference in Percentage|7.9|||=|0.003|TWO_SIDED|95.0|2.8|12.8|||Miettinen & Nurminen method|||Injection-site erythema||12.8|2.8|= 0.003
74032919|NCT01254396|147618852|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|41.35|||||TWO_SIDED|90.0|32.4|52.76||||||Natural log transformed Cmax of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||52.76|32.40|
74032920|NCT01254396|147618854|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|93.42|||||TWO_SIDED|90.0|80.23|108.78||||||Natural log transformed AUC (0-∞) of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||108.78|80.23|
74032921|NCT01254396|147618855|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|87.66|||||TWO_SIDED|90.0|77.62|98.99||||||Natural log transformed AUClast of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||98.99|77.62|
73871841|NCT00566852|147286899|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Assuming normally distributions, the two sample t-test assuming equal variances would be used to compare the arms at the 0.025 significance level. If normality assumptions were not met, the Wilcoxon rank sum would be used.||||0.77
73951777|NCT04147260|147437088|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.083||0.33|TWO_SIDED|90.0|-0.09|0.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.25|-0.09|0.330
73951778|NCT04147260|147437088|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.113||0.754|TWO_SIDED|90.0|-0.26|0.19||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.19|-0.26|0.754
73951779|NCT04147260|147437089|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|90.0|0.09|0.52|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.52|0.09|
73951780|NCT04147260|147437089|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.151|TWO_SIDED|90.0|-0.06|0.38||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.38|-0.06|0.151
73951781|NCT04147260|147437089|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.145||0.319|TWO_SIDED|90.0|-0.15|0.44||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.44|-0.15|0.319
73951782|NCT04147260|147437089|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|90.0|-0.04|0.42|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.42|-0.04|
73951783|NCT04147260|147437089|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.112||0.246|TWO_SIDED|90.0|-0.09|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.09|0.246
73951784|NCT04147260|147437089|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.151||0.704|TWO_SIDED|90.0|-0.25|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.25|0.704
73951785|NCT04147260|147437090|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|4.929||0.692|TWO_SIDED|90.0|-11.92|7.99||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.99|-11.92|0.692
73951786|NCT04147260|147437090|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|4.048||0.63|TWO_SIDED|90.0|-10.14|6.21||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||6.21|-10.14|0.630
73951787|NCT04147260|147437090|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|5.482||1|TWO_SIDED|90.0|-11.07|11.07||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||11.07|-11.07|1.000
73951788|NCT04147260|147437090|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|4.518||0.751|TWO_SIDED|90.0|-10.55|7.66||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.66|-10.55|0.751
73979255|NCT03692871|147504253|OTHER||Difference in Percentage|-0.3|||=|0.882|TWO_SIDED|95.0|-5.0|4.0|||Miettinen & Nurminen method|||Injection-site induration||4.0|-5.0|= 0.882
73979256|NCT03692871|147504253|OTHER||Difference in Percentage|6.4|||=|0.014|TWO_SIDED|95.0|1.3|11.3|||Miettinen & Nurminen method|||Injection-site pain||11.3|1.3|= 0.014
73979257|NCT03692871|147504253|OTHER||Difference in Percentage|4.6|||=|0.051|TWO_SIDED|95.0|0.0|8.9|||Miettinen & Nurminen method|||Injection-site swelling||8.9|0.0|= 0.051
73979258|NCT03692871|147504254|OTHER||Difference in Percentage|5.5|||=|0.033|TWO_SIDED|95.0|0.4|10.5|||Miettinen & Nurminen method|||Decreased appetite||10.5|0.4|= 0.033
73979259|NCT03692871|147504254|OTHER||Difference in Percentage|5.6|||=|0.016|TWO_SIDED|95.0|1.0|10.5|||Miettinen & Nurminen method|||Irritability||10.5|1.0|= 0.016
73979260|NCT03692871|147504254|OTHER||Difference in Percentage|0.4|||=|0.878|TWO_SIDED|95.0|-4.7|5.6|||Miettinen & Nurminen method|||Somnolence||5.6|-4.7|= 0.878
73871842|NCT00566852|147286900|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.27|TWO_SIDED|95.0|0.87|1.3|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||1.3|0.87|0.27
73951789|NCT04147260|147437090|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|3.894||0.669|TWO_SIDED|90.0|-6.17|9.52||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.52|-6.17|0.669
73951790|NCT04147260|147437090|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|5.123||0.546|TWO_SIDED|90.0|-13.44|7.21||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.21|-13.44|0.546
73951791|NCT04147260|147437091|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-12.45|STANDARD_ERROR_OF_MEAN|11.385||0.281|TWO_SIDED|90.0|-35.44|10.54||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||10.54|-35.44|0.281
73951792|NCT04147260|147437091|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-16.14|STANDARD_ERROR_OF_MEAN|9.35||0.092|TWO_SIDED|90.0|-35.02|2.74||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||2.74|-35.02|0.092
73951793|NCT04147260|147437091|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|3.69|STANDARD_ERROR_OF_MEAN|12.662||0.772|TWO_SIDED|90.0|-21.88|29.27||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||29.27|-21.88|0.772
73979261|NCT03692871|147504254|OTHER||Difference in Percentage|-0.8|||=|0.503|TWO_SIDED|95.0|-3.8|1.5|||Miettinen & Nurminen method|||Urticaria||1.5|-3.8|= 0.503
73979262|NCT03692871|147504255|OTHER||Difference in Percentage|0.1|||||TWO_SIDED|95.0|-0.8|0.4||||||Percentage of participants with a vaccine-related SAE||0.4|-0.8|
73979263|NCT03989232|147504263|SUPERIORITY||Treatment difference|-0.23||||0.0003|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||On-treatment without rescue medication observation period: Imputation of missing data was handled by multiple imputation (MI) assuming that missing data were missed at random (MAR). The imputation was performed separately within each treatment group defined by randomised treatment.||-0.11|-0.36|0.0003
73979264|NCT03989232|147504263|SUPERIORITY||Treatment difference|-0.18||||0.0098|TWO_SIDED|95.0|-0.31|-0.04|||ANCOVA|||In-trial observation period: Imputation of missing data was handled by MI assuming that missing data were missed at random. The imputation was performed by imputing missing week 40 data separately within groups defined by randomised treatment and treatment status at week 40.||-0.04|-0.31|0.0098
73979265|NCT03182244|147504286|SUPERIORITY||Hazard Ratio (HR)|0.612||||0.00152|TWO_SIDED|95.0|0.451|0.832|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per interactive response technology (IRT).|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||0.832|0.451|0.00152
73979266|NCT03182244|147504287|SUPERIORITY||Hazard Ratio (HR)|0.589||||5e-05|TWO_SIDED|95.0|0.438|0.792|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||0.792|0.438|0.00005
73951794|NCT04147260|147437091|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-8.21|STANDARD_ERROR_OF_MEAN|13.255||0.539|TWO_SIDED|90.0|-34.93|18.5||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||18.50|-34.93|0.539
73979267|NCT03182244|147504288|SUPERIORITY||Treatment difference|8.9||||0.04256|TWO_SIDED|95.0|0.3|17.5|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||17.5|0.3|0.04256
73979268|NCT03182244|147504289|SUPERIORITY||Hazard Ratio (HR)|1.163||||0.8871|TWO_SIDED|95.0|0.131|10.338|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||10.338|0.131|0.88710
73951795|NCT04147260|147437091|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-4.71|STANDARD_ERROR_OF_MEAN|11.424||0.682|TWO_SIDED|90.0|-27.74|18.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||18.31|-27.74|0.682
73979269|NCT03182244|147504290|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.55969|TWO_SIDED|95.0|0.209|2.414|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||2.414|0.209|0.55969
73979270|NCT03182244|147504291|SUPERIORITY||Hazard Ratio (HR)|1.583||||0.66261|TWO_SIDED|95.0|0.192|13.048|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||13.048|0.192|0.66261
73871843|NCT00566852|147286901|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.025|TWO_SIDED|95.0|0.86|1.31|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||1.31|0.86|0.025
73871844|NCT01702246|147286935|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||Wilcoxon matched pairs signed rank test|Wilcoxon (Mann-Whitney)|||||||0.005
74089398|NCT02697773|147731621|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.0078|TWO_SIDED|95.0|-1.03|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-1.03|0.0078
73871845|NCT01702246|147286936|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
73871846|NCT01702246|147286937|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
73871847|NCT04607837|147286951|SUPERIORITY||Risk Difference (RD)|7.35||||0.2524|TWO_SIDED|95.0|-5.24|19.94|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common risk difference using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the risk difference being 0.||19.94|-5.24|0.2524
73871848|NCT04607837|147286952|SUPERIORITY||Risk Difference (RD)|15.61||||0.0068|TWO_SIDED|95.0|4.31|26.91|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||26.91|4.31|0.0068
73951796|NCT04147260|147437091|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|15.03||0.817|TWO_SIDED|90.0|-33.79|26.79||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||26.79|-33.79|0.817
73951797|NCT04147260|147437092|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|5.327||0.891|TWO_SIDED|90.0|-11.49|10.02||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||10.02|-11.49|0.891
73951798|NCT04147260|147437092|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.59|STANDARD_ERROR_OF_MEAN|4.375||0.417|TWO_SIDED|90.0|-12.42|5.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.25|-12.42|0.417
73951799|NCT04147260|147437092|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|5.925||0.633|TWO_SIDED|90.0|-9.11|14.82||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.82|-9.11|0.633
73951800|NCT04147260|147437092|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|6.79|STANDARD_ERROR_OF_MEAN|4.384||0.129|TWO_SIDED|90.0|-2.05|15.62||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||15.62|-2.05|0.129
73951801|NCT04147260|147437092|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|3.778||0.548|TWO_SIDED|90.0|-5.33|9.9||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.90|-5.33|0.548
73951802|NCT04147260|147437092|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|4.97||0.37|TWO_SIDED|90.0|-5.51|14.52||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.52|-5.51|0.370
73951803|NCT04147260|147437093|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|10.379||0.375|TWO_SIDED|90.0|-30.26|11.66||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||11.66|-30.26|0.375
73951804|NCT04147260|147437093|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-11.49|STANDARD_ERROR_OF_MEAN|8.524||0.185|TWO_SIDED|90.0|-28.7|5.73||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.73|-28.70|0.185
73951805|NCT04147260|147437093|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|11.544||0.851|TWO_SIDED|90.0|-21.12|25.5||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||25.50|-21.12|0.851
73951806|NCT04147260|147437093|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-26.64|STANDARD_ERROR_OF_MEAN|9.405||0.007|TWO_SIDED|90.0|-45.59|-7.69||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-7.69|-45.59|0.007
73871849|NCT04607837|147286953|SUPERIORITY||Risk Difference (RD)|8.24||||0.2302|TWO_SIDED|95.0|-5.22|21.71|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.71|-5.22|0.2302
73871850|NCT04607837|147286954|SUPERIORITY||Risk Difference (RD)|7.12||||0.3339|TWO_SIDED|95.0|-7.32|21.55|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||21.55|-7.32|0.3339
73951807|NCT04147260|147437093|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-15.01|STANDARD_ERROR_OF_MEAN|8.106||0.071|TWO_SIDED|90.0|-31.34|1.33||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||1.33|-31.34|0.071
73951808|NCT04147260|147437093|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-11.63|STANDARD_ERROR_OF_MEAN|10.664||0.281|TWO_SIDED|90.0|-33.13|9.86||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.86|-33.13|0.281
73951809|NCT04147260|147437094|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|5.37||0.599|TWO_SIDED|90.0|-13.69|8.0||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||8.00|-13.69|0.599
73951810|NCT04147260|147437094|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|4.41||0.824|TWO_SIDED|90.0|-7.92|9.9||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.90|-7.92|0.824
73951811|NCT04147260|147437094|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.83|STANDARD_ERROR_OF_MEAN|5.973||0.525|TWO_SIDED|90.0|-15.9|8.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||8.23|-15.90|0.525
73951812|NCT04147260|147437094|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|6.867||0.25|TWO_SIDED|90.0|-21.84|5.84||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.84|-21.84|0.250
73951813|NCT04147260|147437094|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|5.19|STANDARD_ERROR_OF_MEAN|5.919||0.386|TWO_SIDED|90.0|-6.74|17.12||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||17.12|-6.74|0.386
73979271|NCT03182244|147504292|SUPERIORITY||Hazard Ratio (HR)|0.756||||0.55731|TWO_SIDED|95.0|0.286|1.999|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||1.999|0.286|0.55731
73979272|NCT03182244|147504293|SUPERIORITY||Treatment difference|17.7||||0.00049|TWO_SIDED|95.0|7.9|27.5|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||27.5|7.9|0.00049
73979273|NCT03182244|147504295|SUPERIORITY||Hazard Ratio (HR)|0.857||||0.56944|TWO_SIDED|95.0|0.494|1.487|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||1.487|0.494|0.56944
73871851|NCT04607837|147286955|SUPERIORITY||Risk Difference (RD)|0.68||||0.9141|TWO_SIDED|95.0|-11.76|13.13|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||13.13|-11.76|0.9141
73871852|NCT04607837|147286956|SUPERIORITY||Risk Difference (RD)|9.56||||0.1089|TWO_SIDED|95.0|-2.13|21.25|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.25|-2.13|0.1089
73951814|NCT04147260|147437094|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-13.19|STANDARD_ERROR_OF_MEAN|7.787||0.097|TWO_SIDED|90.0|-28.88|2.51||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||2.51|-28.88|0.097
73951815|NCT04147260|147437095|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|6.842||0.885|TWO_SIDED|90.0|-12.83|14.81||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.81|-12.83|0.885
73979274|NCT03182244|147504296|SUPERIORITY||Treatment difference|31.2|||<|1e-05|TWO_SIDED|95.0|20.2|42.3|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||42.3|20.2|<0.00001
73979275|NCT03182244|147504302|SUPERIORITY||Treatment difference|14.7||||0.00055|TWO_SIDED|95.0|6.5|22.8|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||22.8|6.5|0.00055
73871853|NCT04607837|147286957|SUPERIORITY||Risk Difference (RD)|11.19||||0.0104|TWO_SIDED|95.0|2.63|19.75|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||19.75|2.63|0.0104
73871854|NCT04607837|147286958|SUPERIORITY||Risk Difference (RD)|-1.07||||0.9203|TWO_SIDED|95.0|-22.06|19.92|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||19.92|-22.06|0.9203
73871855|NCT04607837|147286959|SUPERIORITY||Risk Difference (RD)|8.49||||0.1726|TWO_SIDED|95.0|-3.71|20.68|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||20.68|-3.71|0.1726
73871856|NCT04607837|147286960|SUPERIORITY||Risk Difference (RD)|-1.71||||0.9272|TWO_SIDED|95.0|-38.31|34.9|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||34.90|-38.31|0.9272
73871857|NCT04607837|147286961|SUPERIORITY||Risk Difference (RD)|8.49||||0.1726|TWO_SIDED|95.0|-3.71|20.68|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||20.68|-3.71|0.1726
73871858|NCT04607837|147286962|SUPERIORITY||Risk Difference (RD)|18.64||||0.0151|TWO_SIDED|95.0|3.61|33.67|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||33.67|3.61|0.0151
73871859|NCT04607837|147286963|SUPERIORITY||Risk Difference (RD)|5.96||||0.4419|TWO_SIDED|95.0|-9.22|21.13|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.13|-9.22|0.4419
73979276|NCT03182244|147504303|SUPERIORITY||Least square mean difference|0.6||||0.14841||||||Analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. LS Mean difference was estimated using chemotherapy as control.|ANCOVA|||||||0.14841
73979277|NCT00257894|147504322|SUPERIORITY_OR_OTHER|||||||0.57||||||Effect size close to zero (eta squared of .01)|ANOVA|Interaction effect term from group by time ANOVA||||||.57
73979278|NCT00257894|147504323|SUPERIORITY_OR_OTHER|||||||0.6||||||Effect size about zero (eta squared = .01)|ANOVA|Interaction term from a group by time ANOVA||||||.60
74032922|NCT02538666|147618865|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3693|TWO_SIDED|95.0|0.75|1.12|||Stratified Log Rank|Stratified by response to ECOG PS (0vs1), gender (MvF), irradiation following chemotherapy (YorN) as entered in IVRS|based on stratified 3-arms Cox proportional hazard model|nivolumab + ipilimumab over placebo||1.12|0.75|0.3693
73871860|NCT04607837|147286964|SUPERIORITY||Risk Difference (RD)|23.33||||0.0007|TWO_SIDED|95.0|9.78|36.89|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||36.89|9.78|0.0007
73871861|NCT04607837|147286965|SUPERIORITY||Risk Difference (RD)|14.99||||0.0128|TWO_SIDED|95.0|3.19|26.79|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||26.79|3.19|0.0128
73871862|NCT04607837|147286966|SUPERIORITY||Risk Difference (RD)|10.24||||0.1492|TWO_SIDED|95.0|-3.67|24.14|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||24.14|-3.67|0.1492
73871863|NCT04607837|147286967|SUPERIORITY||Risk Difference (RD)|0.18||||0.9774|TWO_SIDED|95.0|-12.18|12.53|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||12.53|-12.18|0.9774
73979279|NCT00257894|147504324|SUPERIORITY_OR_OTHER|||||||0.79||||||Effect size (eta squared) = 0|ANOVA|Interaction term of a group by time ANOVA||||||.79
73979280|NCT00257894|147504325|SUPERIORITY_OR_OTHER|||||||0.21||||||For test of drug by time interaction effect|ANOVA|Medium effect size, eta squared = .061||Analysis of variance, group by time (Day 0 vs. Day 10).||||.21
73979281|NCT01316913|147504327|SUPERIORITY_OR_OTHER||Least squares mean difference|0.022||||0.377|TWO_SIDED|95.0|-0.027|0.072|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus UMEC 125 µg.|||0.072|-0.027|0.377
73979282|NCT01316913|147504327|SUPERIORITY_OR_OTHER||Least squares mean difference|0.06||||0.018|TWO_SIDED|95.0|0.01|0.109||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.|||0.109|0.010|0.018
73979283|NCT01316913|147504327|SUPERIORITY_OR_OTHER||Least squares mean difference|0.037||||0.142|TWO_SIDED|95.0|-0.012|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.087|-0.012|0.142
73979284|NCT01316913|147504327|SUPERIORITY_OR_OTHER||Least squares mean difference|0.074||||0.003|TWO_SIDED|95.0|0.025|0.123|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.|||0.123|0.025|0.003
73871864|NCT04607837|147286968|SUPERIORITY||Risk Difference (RD)|22.83||||0.0011|TWO_SIDED|95.0|9.17|36.49|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||36.49|9.17|0.0011
74032923|NCT02538666|147618866|SUPERIORITY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.68|0.97|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab over global placebo||0.97|0.68|
73979285|NCT02691702|147504357|OTHER|MMRM|Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|90.0|-63.09|60.57|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)|||60.57|-63.09|
73979286|NCT02691702|147504357|OTHER|MMRM|Mean Difference (Final Values)|-27.13|STANDARD_ERROR_OF_MEAN|38.61|||TWO_SIDED|90.0|-91.24|36.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)|||36.97|-91.24|
73979287|NCT02691702|147504357|OTHER|MMRM|Mean Difference (Final Values)|43.72|STANDARD_ERROR_OF_MEAN|45.72|||TWO_SIDED|90.0|-32.19|119.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)|||119.62|-32.19|
73979288|NCT02691702|147504357|OTHER|MMRM|Mean Difference (Final Values)|61.48|STANDARD_ERROR_OF_MEAN|40.88|||TWO_SIDED|90.0|-6.38|129.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||129.35|-6.38|
73979289|NCT02691702|147504357|OTHER|MMRM|Mean Difference (Final Values)|125.87|STANDARD_ERROR_OF_MEAN|39.37|||TWO_SIDED|90.0|60.51|191.23|||||Test (PF-05251749 400 mg AM) Reference (Placebo)|||191.23|60.51|
73979290|NCT02691702|147504357|OTHER|MMRM|Mean Difference (Final Values)|156.22|STANDARD_ERROR_OF_MEAN|42.91|||TWO_SIDED|90.0|84.99|227.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)|||227.45|84.99|
73979291|NCT02691702|147504357|OTHER|MMRM|Mean Difference (Final Values)|51.42|STANDARD_ERROR_OF_MEAN|33.12|||TWO_SIDED|90.0|-3.57|106.41|||||Test (PF-05251749 50 mg PM) Reference (Placebo)|||106.41|-3.57|
73979292|NCT02691702|147504357|OTHER|MMRM|Mean Difference (Final Values)|142.74|STANDARD_ERROR_OF_MEAN|36.13|||TWO_SIDED|90.0|82.76|202.72|||||Test (PF-05251749 200 mg PM) Reference (Placebo)|||202.72|82.76|
73979293|NCT02691702|147504357|OTHER|MMRM|Mean Difference (Final Values)|174.9|STANDARD_ERROR_OF_MEAN|36.01|||TWO_SIDED|90.0|115.11|234.69|||||Test (PF-05251749 500 mg PM) Reference (Placebo)|||234.69|115.11|
73979294|NCT02691702|147504358|OTHER|MMRM|Mean Difference (Final Values)|-71.26|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|90.0|-133.09|-9.43|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)|||-9.43|-133.09|
73979295|NCT02691702|147504358|OTHER|MMRM|Mean Difference (Final Values)|-12.13|STANDARD_ERROR_OF_MEAN|38.61|||TWO_SIDED|90.0|-76.24|51.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)|||51.97|-76.24|
74089399|NCT02697773|147731621|SUPERIORITY||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.35|-0.43|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-1.35|0.0002
73979296|NCT02691702|147504358|OTHER|MMRM|Mean Difference (Final Values)|88.72|STANDARD_ERROR_OF_MEAN|45.72|||TWO_SIDED|90.0|12.81|164.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)|||164.62|12.81|
73979297|NCT02691702|147504358|OTHER|MMRM|Mean Difference (Final Values)|46.48|STANDARD_ERROR_OF_MEAN|40.88|||TWO_SIDED|90.0|-21.38|114.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||114.35|-21.38|
73979298|NCT02691702|147504358|OTHER|MMRM|Mean Difference (Final Values)|87.3|STANDARD_ERROR_OF_MEAN|39.37|||TWO_SIDED|90.0|21.94|152.66|||||Test (PF-05251749 400 mg AM) Reference (Placebo)|||152.66|21.94|
73979299|NCT02691702|147504358|OTHER|MMRM|Mean Difference (Final Values)|126.22|STANDARD_ERROR_OF_MEAN|42.91|||TWO_SIDED|90.0|54.99|197.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)|||197.45|54.99|
73979300|NCT02691702|147504358|OTHER|MMRM|Mean Difference (Final Values)|92.36|STANDARD_ERROR_OF_MEAN|35.48|||TWO_SIDED|90.0|33.51|151.21|||||Test (PF-05251749 50 mg PM) Reference (Placebo)|||151.21|33.51|
73979301|NCT02691702|147504358|OTHER|MMRM|Mean Difference (Final Values)|107.29|STANDARD_ERROR_OF_MEAN|36.13|||TWO_SIDED|90.0|47.31|167.27|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||167.27|47.31|
73979302|NCT02691702|147504358|OTHER|MMRM|Mean Difference (Final Values)|140.61|STANDARD_ERROR_OF_MEAN|37.79|||TWO_SIDED|90.0|77.91|203.3|||||Test (PF-05251749 500 mg AM) Reference (Placebo)|||203.30|77.91|
73979303|NCT02060487|147504374|NON_INFERIORITY|Non-inferiority of sildenafil 20 mg TID versus sildenafil 5 mg TID was to be concluded if the upper limit of the 99.7% confidence interval (CI) for hazard ratio (HR) was less than 2.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|99.7|0.31|1.49|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.49|0.31|
73979304|NCT02060487|147504374|NON_INFERIORITY|Non-inferiority of sildenafil 80 mg TID vs. sildenafil 5 mg TID was to be concluded if the upper limit of the 99.7% CI for HR was less than 2.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|99.7|0.22|1.21|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.21|0.22|
73979305|NCT02060487|147504374|NON_INFERIORITY|Non-inferiority of sildenafil 80 mg TID vs. sildenafil 20 mg TID was to be concluded if the upper limit of the 99.7% CI for HR is less than 2.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|99.7|0.3|1.84|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.84|0.30|
73979306|NCT02060487|147504375|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.035|TWO_SIDED|99.7|0.33|1.21|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.21|0.33|0.035
73979307|NCT02060487|147504375|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|99.7|0.22|0.89|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||0.89|0.22|<0.001
73979308|NCT02060487|147504375|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.195|TWO_SIDED|99.7|0.34|1.52|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.52|0.34|0.195
73979309|NCT02060487|147504376|SUPERIORITY||Least-squares means difference|15.0||||0.0627|TWO_SIDED|95.0|-0.8|30.81|||MMRM|||||30.81|-0.80|0.0627
73979310|NCT02060487|147504376|SUPERIORITY||Least-squares means difference|18.9||||0.0201|TWO_SIDED|95.0|2.99|34.86|||MMRM|||||34.86|2.99|0.0201
73979311|NCT02060487|147504376|SUPERIORITY||Least-squares means difference|3.9||||0.6254|TWO_SIDED|95.0|-11.85|19.68|||MMRM|||||19.68|-11.85|0.6254
73979312|NCT02060487|147504377|SUPERIORITY||Least-squares means difference|21.3||||0.0286|TWO_SIDED|95.0|2.25|40.45|||MMRM|||||40.45|2.25|0.0286
74089400|NCT02697773|147731621|SUPERIORITY||Least Square Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.5|-0.57|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.57|-1.50|<.0001
73979313|NCT02060487|147504377|SUPERIORITY||Least-squares means difference|20.5||||0.0364|TWO_SIDED|95.0|1.3|39.65|||MMRM|||||39.65|1.30|0.0364
73979314|NCT02060487|147504377|SUPERIORITY||Least-squares means difference|-0.9||||0.9283|TWO_SIDED|95.0|-19.94|18.19|||MMRM|||||18.19|-19.94|0.9283
73979315|NCT03212638|147504379|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|1.04|||||TWO_SIDED|95.0|0.946|1.15||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.15|0.946|
73979316|NCT03212638|147504379|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|1.04|||||TWO_SIDED|95.0|0.944|1.14||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).||1.14|0.944|
73979317|NCT03212638|147504379|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.675|||||TWO_SIDED|95.0|0.617|0.74||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||0.740|0.617|
73979318|NCT03212638|147504380|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.996|||||TWO_SIDED|95.0|0.963|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.963|
73979319|NCT03212638|147504380|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.998|||||TWO_SIDED|95.0|0.995|1.03||||||Bioequivalence of s single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).||1.03|0.995|
73979320|NCT03212638|147504380|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|0.973|||||TWO_SIDED|95.0|0.936|1.01||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||1.01|0.936|
73951816|NCT04147260|147437095|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|28.9|STANDARD_ERROR_OF_MEAN|5.619|<|0.001|TWO_SIDED|90.0|17.55|40.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||40.25|17.55|<0.001
73951817|NCT04147260|147437095|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-27.91|STANDARD_ERROR_OF_MEAN|7.61|<|0.001|TWO_SIDED|90.0|-43.28|-12.54||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-12.54|-43.28|<0.001
73979321|NCT03212638|147504381|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||TWO_SIDED|95.0|0.996|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.996|
73979322|NCT03212638|147504381|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||TWO_SIDED|95.0|0.966|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.966|
73951818|NCT04147260|147437095|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-20.13|STANDARD_ERROR_OF_MEAN|8.041||0.016|TWO_SIDED|90.0|-36.33|-3.92||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-3.92|-36.33|0.016
73871865|NCT04607837|147286969|SUPERIORITY||Risk Difference (RD)|10.8||||0.1513|TWO_SIDED|95.0|-3.95|25.56|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||25.56|-3.95|0.1513
73979323|NCT03212638|147504381|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|0.978|||||TWO_SIDED|95.0|0.941|1.02||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||1.02|0.941|
73979324|NCT02970318|147504386|OTHER||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.2|0.49||Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.49|0.20|<0.0001
73979325|NCT02970318|147504387|OTHER||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.2|0.38||Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.38|0.20|<0.0001
73979326|NCT02970318|147504388|OTHER||Risk Difference (RD)|5.8||||0.2248|TWO_SIDED|95.0|-3.3|14.9|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|||14.9|-3.3|0.2248
73979327|NCT02970318|147504389|OTHER||Risk Difference (RD)|-1.3||||0.734|TWO_SIDED|95.0|-9.6|7.0|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|||7.0|-9.6|0.7340
73979328|NCT02970318|147504390|OTHER||Hazard Ratio (HR)|0.69||||0.0783|TWO_SIDED|95.0|0.46|1.04|||Log Rank|Log-Rank Analysis stratified by factors recorded in IXRS data: presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).|Cox proportional hazard analysis stratified (Arm A vs. Arm B) by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).|Analysis stratified by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).||1.04|0.46|0.0783
73979329|NCT02970318|147504391|OTHER||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.19|0.59||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.59|0.19|<0.0001
73871866|NCT04607837|147286970|SUPERIORITY||Risk Difference (RD)|10.07||||0.1823|TWO_SIDED|95.0|-4.73|24.87|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||24.87|-4.73|0.1823
73871867|NCT04346654|147286973|SUPERIORITY|||||||0.5133|||||||Regression, Logistic|||||||0.5133
73871868|NCT04346654|147286974|SUPERIORITY|||||||0.5133|||||||Regression, Logistic|||||||0.5133
73951819|NCT04147260|147437095|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|18.5|STANDARD_ERROR_OF_MEAN|6.931||0.011|TWO_SIDED|90.0|4.53|32.46||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||32.46|4.53|0.011
73951820|NCT04147260|147437095|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-38.62|STANDARD_ERROR_OF_MEAN|9.118|<|0.001|TWO_SIDED|90.0|-57.0|-20.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-20.25|-57.00|<0.001
73951821|NCT02204293|147437123|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.||||||0.1811|||||||Fisher Exact|||||||0.1811
73951822|NCT02204293|147437138|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|19.9||||0.3175|TWO_SIDED|95.0|-15.0|51.3|||Fisher Exact|||||51.3|-15.0|0.3175
73871869|NCT02915978|147286998|OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.89||0.0505|TWO_SIDED|95.0|-3.61|0.0|||ANCOVA|||NRS PID at 1 hour||0.00|-3.61|0.0505
73871870|NCT02915978|147286998|OTHER||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.9||0.2493|TWO_SIDED|95.0|-2.89|0.77|||ANCOVA|||NRS PID at 1 hour||0.77|-2.89|0.2493
73871871|NCT02915978|147286998|OTHER||LS Mean Difference|-2.94|STANDARD_ERROR_OF_MEAN|0.99||0.0052|TWO_SIDED|95.0|-4.95|-0.94|||ANCOVA|||NRS PID at 16 hours||-0.94|-4.95|0.0052
73951823|NCT02204293|147437139|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|31.7||||0.0922|TWO_SIDED|95.0|-2.9|61.8|||Fisher Exact|||||61.8|-2.9|0.0922
73951824|NCT02204293|147437140|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|32.0||||0.0858|TWO_SIDED|95.0|-1.5|61.1|||Fisher Exact|||||61.1|-1.5|0.0858
73979330|NCT02970318|147504392|OTHER||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.16|0.33||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.33|0.16|<0.0001
73979331|NCT02970318|147504393|OTHER||Hazard Ratio (HR)|0.29|||<|0.0001|TWO_SIDED|95.0|0.21|0.4||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.40|0.21|<0.0001
73951825|NCT02204293|147437141|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|32.4||||0.075|TWO_SIDED|95.0|-0.7|60.5|||Fisher Exact|||||60.5|-0.7|0.075
73951826|NCT02204293|147437142|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|16.0||||0.4018|TWO_SIDED|95.0|-12.6|43.4|||Fisher Exact|||||43.4|-12.6|0.4018
73951827|NCT02204293|147437143|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|5.2||||1|TWO_SIDED|95.0|-18.8|29.2|||Fisher Exact|||||29.2|-18.8|1
73871872|NCT02915978|147286998|OTHER||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.97||0.0926|TWO_SIDED|95.0|-3.62|0.29|||ANCOVA|||NRS PID at 16 hours||0.29|-3.62|0.0926
73951828|NCT02204293|147437144|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|24.8||||0.1642|TWO_SIDED|95.0|-8.0|54.2|||Fisher Exact|||EULAR DAS28-ESR Response||54.2|-8.0|0.1642
73951829|NCT02204293|147437144|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|25.2||||0.1756|TWO_SIDED|95.0|-9.1|55.1|||Fisher Exact|||EULAR DAS28-CRP Response||55.1|-9.1|0.1756
74032924|NCT02538666|147618866|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.53|1.66|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab over China Placebo||1.66|0.53|
73871873|NCT02915978|147286998|OTHER||LS Means Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.82||0.0951|TWO_SIDED|95.0|-3.06|0.26|||ANCOVA|||NRS PID at 24 hours||0.26|-3.06|0.0951
73871874|NCT02915978|147286998|OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.8||0.9866|TWO_SIDED|95.0|-1.6|1.63|||ANCOVA|||NRS PID at 24 hours||1.63|-1.60|0.9866
73871875|NCT02343406|147287026|OTHER||Cox Proportional Hazard|0.71|||=|0.062|TWO_SIDED|95.0|0.5|1.02||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||1.02|0.5|= 0.062
73951830|NCT02204293|147437145|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|3.9||||1|TWO_SIDED|95.0|-27.7|35.0|||Fisher Exact|||DAS28 (ESR) LDA||35.0|-27.7|1
73951831|NCT02204293|147437145|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|26.5||||0.1642|TWO_SIDED|95.0|-6.6|56.0|||Fisher Exact|||DAS28 (CRP) LDA||56.0|-6.6|0.1642
73951832|NCT02204293|147437146|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|21.6||||0.2285|TWO_SIDED|95.0|-8.1|49.9|||Fisher Exact|||DAS28 (ESR) remission||49.9|-8.1|0.2285
73871876|NCT02343406|147287026|OTHER||Cox Proportional Hazard|1.04|||=|0.835|TWO_SIDED|95.0|0.73|1.48||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||1.48|0.73|= 0.835
73871877|NCT02343406|147287027|OTHER||Cox Proportional Hazard|0.77|||=|0.123|TWO_SIDED|95.0|0.55|1.07||2-sided|Log Rank|||||1.07|0.55|= 0.123
73871878|NCT02343406|147287027|OTHER||Cox Proportional Hazard|1.31|||=|0.117|TWO_SIDED|95.0|0.93|1.84||2-sided|Log Rank|||||1.84|0.93|= 0.117
73951833|NCT02204293|147437146|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|27.1||||0.1212|TWO_SIDED|95.0|-4.6|54.6|||Fisher Exact|||DAS28 (CRP) Remission||54.6|-4.6|0.1212
73951834|NCT02204293|147437146|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|16.0||||0.4018|TWO_SIDED|95.0|-12.6|43.4|||Fisher Exact|||Extended Remission||43.4|-12.6|0.4018
73951835|NCT01058863|147437156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.88|1.42||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.42|0.88|<0.0001
73951836|NCT01058863|147437156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.7|1.24||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.24|0.70|<0.0001
73951837|NCT01058863|147437156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.81|1.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level..||1.35|0.81|<0.0001
73951838|NCT01058863|147437156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.61|1.15||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.15|0.61|<0.0001
73951839|NCT01058863|147437157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.47|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|26.21|40.74||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||40.74|26.21|<0.0001
73951840|NCT01058863|147437157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.73|STANDARD_ERROR_OF_MEAN|3.686|<|0.001|TWO_SIDED|95.0|20.47|34.99||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||34.99|20.47|<0.001
74032925|NCT02538666|147618867|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.36|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over global nivolumab||1.36|0.94|
73871879|NCT02343406|147287035|OTHER||Odds Ratio (OR)|3.1|||=|0.06|TWO_SIDED|95.0|0.6|16.16||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||16.16|0.6|= 0.06
73871880|NCT02343406|147287035|OTHER||Odds Ratio (OR)|1.21|||=|0.767|TWO_SIDED|95.0|0.12|12.49||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||12.49|0.12|= 0.767
73871881|NCT02343406|147287036|OTHER||Cox Proportional Hazard|0.67|||=|0.127|TWO_SIDED|95.0|0.4|1.13||2-sided|Log Rank|||||1.13|0.4|= 0.127
73951841|NCT01058863|147437157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.1|STANDARD_ERROR_OF_MEAN|3.686|<|0.0001|TWO_SIDED|95.0|25.84|40.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||40.35|25.84|<0.0001
73871882|NCT02343406|147287036|OTHER||Cox Proportional Hazard|0.88|||=|0.64|TWO_SIDED|95.0|0.52|1.49||2-sided|Log Rank|||||1.49|0.52|= 0.64
73951842|NCT01058863|147437157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.61|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|18.36|32.85||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||32.85|18.36|<0.0001
73871883|NCT00806988|147287112|OTHER|An intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level was used. This analysis accommodated missing LVESVI outcomes owing to death by assigning deceased patients the worst ranks in order according to the time of death. In the case of data that were missing for reasons other than death, we used multiple imputation to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.61|||||||Wilcoxon (Mann-Whitney)|||The primary null hypothesis was that there would be no significant between-group difference in the LVESVI at 12 months.||||0.61
73951843|NCT00598481|147437167|SUPERIORITY|||||||0.005|||||||One-sided Poisson-regression|||||||0.005
73951844|NCT00598481|147437168|SUPERIORITY||Geometric mean ratio|3.0||||0.003|TWO_SIDED|95.0|1.45|6.19||P value related to geometric mean ratio at 1 year post gene therapy compared to baseline|Mixed Model Repeated Measures|||||6.19|1.45|0.003
73951845|NCT00598481|147437168|SUPERIORITY||Geometric mean ratio|5.4|||<|0.001|TWO_SIDED|95.0|2.63|11.25||P value related to geometric mean ratio at 2 years post gene therapy compared to baseline|Mixed Model Repeated Measures|||||11.25|2.63|<0.001
73871884|NCT00806988|147287113|OTHER|||||||0.83|||||||Chi-squared|||||||0.83
73951846|NCT00598481|147437168|SUPERIORITY||Geometric mean ratio|6.5|||<|0.001|TWO_SIDED|95.0|3.08|13.64||P value related to geometric mean ratio at 3 years post gene therapy compared to baseline|Mixed Model Repeated Measures|||||13.64|3.08|<0.001
73957994|NCT03368001|147451528|OTHER|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses. We accounted for any non-independence of observations due to cohort membership by obtaining cluster-robust standard errors using robust maximum likelihood estimation (MLR in Mplus) in tandem with the Type = Complex option available in Mplus, treating cohorts as clusters. All models were structurally saturated, so model fit was necessarily perfect.||||||0.039||||||IFM Posttest.|Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||Population models were specified using parameter values derived from past research in tandem with minimal expected effect sizes for the effects of most interest. These models were used to generate 5000 samples for a given N, the models were fit to each sample, and the significance (or not) of key effects was noted. This process was repeated until the target power of at least .80 was reached indicating with 216 participants we would have .82 power.||||.039
73957995|NCT03368001|147451528|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator.|Structural Equation Model (SEM)|0.064|||<|0.05|TWO_SIDED|90.0|0.014|0.118||One-tailed significance test|Structural Equation Model (SEM)|Controlling for Verbal Expressiveness at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The indirect effect of SENSE Theatre® vs. TTT through post-test IFM on follow-up Vocal Expressiveness. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.118|0.014|<0.05
73957996|NCT03368001|147451528|OTHER|The residual associated with the mediator was allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|0.032|||<|0.05|TWO_SIDED|90.0|0.002|0.087||One-sided hypothesis test.|Structural Equation Model (SEM)|Controlling for Rapport at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up Quality of Rapport through posttest Incidental Face Memory. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag (pretest to posttest) and baseline mediator, and controlled the outcome for individual differences in lag (pretest to follow-up) and baseline outcome.||0.087|0.002|<0.05
73979332|NCT00824408|147504394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.045||||0.003|TWO_SIDED|95.0|1.271|3.292|||Log Rank|||Hazard ratio and 95% confidence interval (CI) from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).||3.292|1.271|0.0030
73979333|NCT00824408|147504394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.141||||0.2804|TWO_SIDED|95.0|0.735|1.771|||Log Rank|||Hazard ratio and 95% CI from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg/m2; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).||1.771|0.735|0.2804
73979334|NCT00824408|147504395|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
73951847|NCT04212169|147437188|SUPERIORITY||Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|8.981||0.888|TWO_SIDED|90.0|-13.67|16.22|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||16.22|-13.67|0.888
73951848|NCT04212169|147437188|SUPERIORITY||Mean Difference (Final Values)|5.87|STANDARD_ERROR_OF_MEAN|9.756||0.549|TWO_SIDED|90.0|-10.36|22.1|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||22.10|-10.36|0.549
73979335|NCT00824408|147504395|SUPERIORITY_OR_OTHER|||||||0.2596|||||||Fisher Exact|||||||0.2596
73979336|NCT00824408|147504396|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.8406|TWO_SIDED|95.0|0.538|2.14|||Log Rank|||||2.140|0.538|0.8406
73979337|NCT00824408|147504396|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.081||||0.396|TWO_SIDED|95.0|0.599|1.949|||Log Rank|||||1.949|0.599|0.3960
73979338|NCT03292692|147504414|SUPERIORITY||Slope|0.372|||<|0.001|TWO_SIDED|95.0|0.279|0.465|||Regression, Linear|Multi-level regression|Slope of intervention group compared to slope of the control group|||0.465|0.279|<0.001
73979339|NCT03292692|147504415|SUPERIORITY||Slope|0.17|||<|0.001|TWO_SIDED|95.0|0.105|0.235|||Regression, Linear|Multilevel linear modeling|Slope of the intervention group compared to slope of the control group|||0.235|0.105|<0.001
73979340|NCT03292692|147504416|SUPERIORITY||Mean Difference (Final Values)|-2.149|||<|0.001|TWO_SIDED|95.0|-2.974|-1.324|||Regression, Linear|Multilevel linear regression|Multilevel linear modeling, with time modeled as change from pre-post.|||-1.324|-2.974|<0.001
73979341|NCT03292692|147504417|SUPERIORITY||Mean Difference (Final Values)|-1.144||||0.002|TWO_SIDED|95.0|-1.871|-0.417|||Regression, Linear||Multilevel linear modeling, with time modeled as change from pre to post.|||-0.417|-1.871|0.002
74032926|NCT02538666|147618867|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.56|1.79|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab + ipilimumab over China nivolumab||1.79|0.56|
73951849|NCT04212169|147437188|SUPERIORITY||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|7.014||0.807|TWO_SIDED|90.0|-13.38|9.95|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||9.95|-13.38|0.807
74089401|NCT02697773|147731621|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0034|TWO_SIDED|95.0|-1.16|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-1.16|0.0034
73951850|NCT04212169|147437190|SUPERIORITY||Odds Ratio (OR)|1.53||||0.6396|TWO_SIDED|90.0|0.19|9.94|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||9.94|0.19|0.6396
73951851|NCT04212169|147437190|SUPERIORITY||Odds Ratio (OR)|0.76||||0.9999|TWO_SIDED|90.0|0.03|6.38|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||6.38|0.03|0.9999
73979342|NCT01263496|147504429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.401|||||TWO_SIDED|95.0|-0.618|-0.184||||||||-0.184|-0.618|
73979343|NCT01263496|147504429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.548|||||TWO_SIDED|95.0|-0.739|-0.358||||||||-0.358|-0.739|
73979344|NCT01263496|147504429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-0.779|-0.401||||||||-0.401|-0.779|
73979345|NCT01263496|147504429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.708|||||TWO_SIDED|95.0|-0.894|-0.522||||||||-0.522|-0.894|
74032927|NCT02538666|147618868|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.62|0.88|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over global placebo||0.88|0.62|
73951852|NCT04212169|147437190|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0935|TWO_SIDED|90.0|0.91|10.49|||Regression, Logistic||Odds ratio greater than 1 favours MEDI3506|||10.49|0.91|0.0935
73979346|NCT01263496|147504430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||||TWO_SIDED|95.0|-0.538|-0.093||||||||-0.093|-0.538|
73979347|NCT01263496|147504430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.493|||||TWO_SIDED|95.0|-0.684|-0.302||||||||-0.302|-0.684|
73979348|NCT01263496|147504430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|95.0|-0.706|-0.314||||||||-0.314|-0.706|
73979349|NCT01263496|147504430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.647|||||TWO_SIDED|95.0|-0.834|-0.461||||||||-0.461|-0.834|
73979350|NCT01263496|147504431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|||||TWO_SIDED|95.0|-0.479|-0.047||||||||-0.047|-0.479|
73979351|NCT01263496|147504431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.395|||||TWO_SIDED|95.0|-0.598|-0.192||||||||-0.192|-0.598|
73979352|NCT01263496|147504431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.405|||||TWO_SIDED|95.0|-0.616|-0.195||||||||-0.195|-0.616|
73979353|NCT01263496|147504431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.583|||||TWO_SIDED|95.0|-0.78|-0.386||||||||-0.386|-0.780|
73979354|NCT01263496|147504432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|||||TWO_SIDED|95.0|-0.41|0.065||||||||0.065|-0.410|
73979355|NCT01263496|147504432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.319|||||TWO_SIDED|95.0|-0.55|-0.088||||||||-0.088|-0.550|
73979356|NCT01263496|147504432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-0.601|-0.139||||||||-0.139|-0.601|
73979357|NCT01263496|147504432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.533|||||TWO_SIDED|95.0|-0.752|-0.314||||||||-0.314|-0.752|
74032928|NCT02538666|147618868|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.55|0.79|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab over global placebo||0.79|0.55|
73951853|NCT04212169|147437192|SUPERIORITY||Odds Ratio (OR)|3.06||||0.445|TWO_SIDED|90.0|0.08|119.65|||Fisher Exact||Odds ratio greater than one favour MEDI3506|||119.65|0.08|0.4450
73951854|NCT04212169|147437192|SUPERIORITY||Odds Ratio (OR)|0.0||||0.9999|TWO_SIDED|90.0|0.0|28.0|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||28.0|0.0|0.9999
73951855|NCT04212169|147437192|SUPERIORITY||Odds Ratio (OR)|5.5||||0.1132|TWO_SIDED|90.0|0.75|130.35|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||130.35|0.75|0.1132
73951856|NCT01603940|147437216|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.616
73951857|NCT01603940|147437217|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.28
73951858|NCT01603940|147437218|SUPERIORITY_OR_OTHER|||||||0.618|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.618
73871885|NCT04775953|147287114|SUPERIORITY|For participants with the same DOOR, quality-of-life (QoL) was used as a tiebreaker and was calculated as change from baseline QoL to Day 70 QoL score, as assessed by questions from the PROMIS physical function item bank (PROMIS Item Bank v2.0, short form 6b) on the Antibacterial Resistance Leadership Group (ARLG) Bloodstream Infection QoL Measure. Superiority of dalbavancin is concluded if the lower bound of the 95% confidence interval for the DOOR probability is greater than 50%.|Pr(Better DOOR in dalbavancin arm)|47.7|||||TWO_SIDED|95.0|39.84|55.68|||||The DOOR probability is calculated using the Wilcoxon-Mann-Whitney statistic corrected for ties.|Null Hypothesis: Probability that a participant in the dalbavancin arm has a better DOOR than a participant in the standard of care arm plus one-half the probability of equal DOOR is 50% (i.e., no difference in DOOR).||55.68|39.84|
73951859|NCT02718417|147437252|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.989|TWO_SIDED|95.0|1.051|1.946||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||1.946|1.051|0.9890
73951860|NCT02718417|147437252|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.7935|TWO_SIDED|95.0|0.832|1.565||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||1.565|0.832|0.7935
73951861|NCT02718417|147437253|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.8848|TWO_SIDED|95.0|0.76|3.08||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||3.080|0.760|0.8848
73979358|NCT01263496|147504433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|||||TWO_SIDED|95.0|-0.323|0.166||||||||0.166|-0.323|
73979359|NCT01263496|147504433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.241|||||TWO_SIDED|95.0|-0.471|-0.011||||||||-0.011|-0.471|
74032929|NCT02538666|147618868|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.35|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab+ ipilimumab over nivolumab||1.35|0.94|
73951862|NCT02718417|147437253|SUPERIORITY||Hazard Ratio (HR)|1.55||||0.8953|TWO_SIDED|95.0|0.776|3.111||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||3.111|0.776|0.8953
73951863|NCT02718417|147437254|OTHER||Hazard Ratio (HR)|1.21||||0.9278|TWO_SIDED|95.0|0.935|1.578||One-sided log-rank test was used.|Log Rank|||||1.578|0.935|0.9278
73951864|NCT02718417|147437254|OTHER||Hazard Ratio (HR)|0.9||||0.2367|TWO_SIDED|95.0|0.688|1.189||One-sided log-rank test was used.|Log Rank|||||1.189|0.688|0.2367
73951865|NCT02451930|147437328|OTHER|||||||0.4491|||||||Fisher Exact|||||||0.4491
73951866|NCT03123263|147437354|OTHER|Repeated measures one sided ANOVA was used to analyze changes in ejection fraction over time.|||||<|0.0005|||||||ANOVA|F (2,98) =13.974||||||<0.0005
73951867|NCT03226457|147437428|OTHER|Details of the power calculation are published in the Circulation, DOI: 10.1161/CIRCULATIONAHA.120.048739|||||=|0.005||||||(calculated)|ANCOVA|||"Details on the statistical analysis are published in the Circulation, DOI: 10.1161/CIRCULATIONAHA.120.048739~Analyses were performed on the primary and secondary measures comparing empagliflozin versus placebo and assessed by 2-way analysis of covariance correcting for treatment order, baseline value, and any percentage change in furosemide dose at the visit. Data for continuous outcome measures were assessed for normality before analysis."||||= 0.005
73951868|NCT04102540|147437443|OTHER|In this analysis, our null hypothesis was that the median CD4 count at baseline/exposure 1 was exactly equivalent to the median CD4 count following exposure 2 to the intervention.|Median Difference (Net)|57.39||||0.283|TWO_SIDED|95.0|-48.9|163.7||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median CD4 count between baseline/exposure 1 and exposure 2.|Statistical analysis of CD4 count between baseline/exposure 1 and exposure 2 to the intervention.||163.7|-48.9|0.283
73951869|NCT04102540|147437443|OTHER|In this analysis, our null hypothesis was that the median CD4 count at baseline/exposure 1 was exactly equivalent to the median CD4 count following the exposure 3 to the intervention.|Median Difference (Net)|60.83||||0.1823|TWO_SIDED|95.0|-29.5|151.2||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile regression|Random intercepts for subjects were included in the model.|This is the difference in median CD4 count between baseline/exposure 1 and exposure 3.|Statistical analysis of CD4 count between baseline/exposure 1 and exposure 3 to the intervention.||151.2|-29.5|0.1823
74032930|NCT02538666|147618868|SUPERIORITY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.33|1.12|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab + Ipilimumab over China placebo||1.12|0.33|
73979360|NCT01263496|147504433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|||||TWO_SIDED|95.0|-0.59|-0.124||||||||-0.124|-0.590|
73979361|NCT01263496|147504433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.467|||||TWO_SIDED|95.0|-0.692|-0.242||||||||-0.242|-0.692|
73979362|NCT01263496|147504434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.321|0.162||||||||0.162|-0.321|
73979363|NCT01263496|147504434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.294|||||TWO_SIDED|95.0|-0.542|-0.046||||||||-0.046|-0.542|
73979364|NCT01263496|147504434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.341|||||TWO_SIDED|95.0|-0.579|-0.103||||||||-0.103|-0.579|
74032931|NCT02538666|147618868|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.24|0.85|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab over China placebo||0.85|0.24|
73951870|NCT04102540|147437444|OTHER|In this analysis, our null hypothesis was that the median viral load at baseline/exposure 1 was exactly equivalent to the median viral load following exposure 2 to the intervention.|Median Difference (Net)|-42.0||||0.7795|TWO_SIDED|95.0|-339.8|255.8||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression||This is the difference in median viral load between baseline/exposure 1 and exposure 2.|Statistical analysis of viral load between baseline/exposure 1 and exposure 2 to the intervention.||255.8|-339.8|0.7795
73951871|NCT04102540|147437444|OTHER|In this analysis, our null hypothesis was that the median viral load at baseline/exposure 1 was exactly equivalent to the median viral load following exposure 3 to the intervention.|Median Difference (Net)|-63.0||||0.5971|TWO_SIDED|95.0|-296.1|170.1||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|||Statistical analysis of viral load between baseline/exposure 1 and exposure 3 to the intervention.|This is the difference in median viral load between baseline/exposure 1 and exposure 3.|170.1|-296.1|0.5971
73951872|NCT04102540|147437445|OTHER|In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 2 to the intervention.|Median Difference (Net)|2.12|||<|0.0001|TWO_SIDED|95.0|1.2|3.0||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median HIV-Related knowledge scores between baseline/exposure 1 and exposure 2.|Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 2 to the intervention.||3.0|1.2|<.0001
73951873|NCT04102540|147437445|OTHER|In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 3 to the intervention.|Median Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.2|2.8||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median HIV-related knowledge score between baseline/exposure 1 and exposure 3.|Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 3 to the intervention.||2.8|1.2|<.0001
73951874|NCT04102540|147437447|OTHER|In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 2 to the intervention.|Median Difference (Net)|0.01||||0.9879|TWO_SIDED|95.0|-0.7|0.7||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median self-efficacy to manage HIV scale scores between baseline/exposure 1 and exposure 2.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 2 to the intervention.||0.7|-0.7|0.9879
73951875|NCT04102540|147437447|OTHER|In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 3 to the intervention.|Median Difference (Net)|0.57||||0.155|TWO_SIDED|95.0|-0.2|1.4||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median self-efficacy to manage HIV scale scores between baseline/exposure 1 and exposure 3.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.||1.4|-0.2|0.1550
73951876|NCT04102540|147437448|OTHER|In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 2 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.17||||0.819|TWO_SIDED|95.0|0.3|4.52||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|In this model, the odds ratio estimate is for the odds of being non-adherent at exposure 2 relative to the odds of being non-adherent at baseline/exposure 1.|"For analysis, we dichotomized participants adherence as adherent or non-adherent."||4.52|0.30|0.8190
73951877|NCT04102540|147437448|OTHER|In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 3 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|0.3||||0.1332|TWO_SIDED|95.0|0.07|1.43||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|In this model, the odds ratio estimate is for the odds of being non-adherent at exposure 3 relative to the odds of being non-adherent at baseline/exposure 1.|"For analysis, we dichotomized participants adherence as adherent or non-adherent."||1.43|0.07|0.1332
73951878|NCT04102540|147437449|OTHER|In this model, the null hypothesis was that the odds of good health at baseline/exposure 1 were exactly equal to the odds of good health at exposure 2 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.77||||0.316|TWO_SIDED|95.0|0.57|5.46||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|This is the estimated odds ratio of having good health at exposure 2 relative to baseline/exposure 1.|"For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad."||5.46|0.57|0.3160
73979365|NCT01263496|147504434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.487|||||TWO_SIDED|95.0|-0.722|-0.252||||||||-0.252|-0.722|
73979366|NCT01263496|147504435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049|||||TWO_SIDED|95.0|-0.279|0.182||||||||0.182|-0.279|
73979367|NCT01263496|147504435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.234|||||TWO_SIDED|95.0|-0.491|0.023||||||||0.023|-0.491|
73979368|NCT01263496|147504435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.375|||||TWO_SIDED|95.0|-0.605|-0.145||||||||-0.145|-0.605|
73871886|NCT04775953|147287115|NON_INFERIORITY|The non-inferiority margin is -20%. Non-inferiority of dalbavancin is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical efficacy is greater than -20%.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-12.0|14.0|||||Difference in proportions of clinical efficacy for dalbavancin compared to standard of care and 95% confidence interval obtained from a linear regression model.|Null Hypothesis: The proportion of clinical efficacy in the dalbavancin arm minus the proportion of clinical efficacy in the standard of care arm is -20%.||14|-12|
73951879|NCT04102540|147437449|OTHER|In this model, the null hypothesis was that the odds of having good health at baseline/exposure 1 were exactly equal to the odds of having good health at exposure 3 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.12||||0.8609|TWO_SIDED|95.0|0.32|3.93||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|This is the estimated odds ratio of having good health at exposure 3 relative to baseline/exposure 1.|"For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad."||3.93|0.32|0.8609
73951880|NCT04102540|147437450|OTHER|In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 2 to the intervention.|Median Difference (Net)|9.13||||0.0572|TWO_SIDED|95.0|-0.3|18.6||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median current health status between baseline/exposure 1 and exposure 2.|Statistical analysis of current health status between baseline/exposure 1 and exposure 2 to the intervention.||18.6|-0.3|0.0572
73951881|NCT04102540|147437450|OTHER|In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 3 to the intervention.|Median Difference (Net)|13.1||||0.0332|TWO_SIDED|95.0|1.1|25.1||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median current health status between baseline/exposure 1 and exposure 3.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.||25.1|1.1|0.0332
73951882|NCT00479037|147437455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|360.3|||<|0.0001|TWO_SIDED|95.0|256.5|494.3||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||494.3|256.5|<0.0001
73951883|NCT00479037|147437456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|92.9|||<|0.0001|TWO_SIDED|95.0|63.8|127.1||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||127.1|63.8|<0.0001
73951884|NCT00479037|147437457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|138.5|||<|0.0001|TWO_SIDED|95.0|94.8|191.8||P-value corresponding to the tests of treatment effect was adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||191.8|94.8|<0.0001
73951885|NCT00684983|147437472|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.89|TWO_SIDED|95.0|0.58|1.89|||Regression, Cox|||Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.||1.89|0.58|.89
73951886|NCT00684983|147437473|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.93|TWO_SIDED|95.0|0.5|3.0|||Log Rank|||||3|0.5|0.93
73979369|NCT01263496|147504435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.488|||||TWO_SIDED|95.0|-0.724|-0.252||||||||-0.252|-0.724|
73951887|NCT00684983|147437474|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.66|TWO_SIDED|95.0|0.53|1.92|||Log Rank|||||1.92|.53|.66
73951888|NCT00684983|147437476|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.26|TWO_SIDED|95.0|0.09|1.53|||Log Rank|||||1.53|.09|.26
73979370|NCT01263496|147504436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.27|0.169||||||||0.169|-0.270|
73979371|NCT01263496|147504436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193|||||TWO_SIDED|95.0|-0.453|0.067||||||||0.067|-0.453|
73979372|NCT01263496|147504436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.374|||||TWO_SIDED|95.0|-0.596|-0.152||||||||-0.152|-0.596|
73979373|NCT01263496|147504436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.723|-0.256||||||||-0.256|-0.723|
73979374|NCT01263496|147504437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||||TWO_SIDED|95.0|-0.16|0.289||||||||0.289|-0.160|
73979375|NCT01263496|147504437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.236|||||TWO_SIDED|95.0|-0.477|0.005||||||||0.005|-0.477|
73979376|NCT01263496|147504437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.608|-0.113||||||||-0.113|-0.608|
73979377|NCT01263496|147504437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.435|||||TWO_SIDED|95.0|-0.679|-0.191||||||||-0.191|-0.679|
73979378|NCT01263496|147504438|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.033|||||TWO_SIDED|95.0|-0.262|0.196||||||||0.196|-0.262|
73979379|NCT01263496|147504438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.262|||||TWO_SIDED|95.0|-0.516|-0.008||||||||-0.008|-0.516|
73871887|NCT02813889|147287135|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0146||||0.0054|TWO_SIDED|95.0|-0.0261|-0.0031||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0031|-0.0261|0.0054
73871888|NCT02813889|147287136|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.02||||0.0005|TWO_SIDED|95.0|-0.0331|-0.007||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0070|-0.0331|0.0005
73871889|NCT02813889|147287137|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0146||||0.0088|TWO_SIDED|95.0|-0.0267|-0.0026||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0026|-0.0267|0.0088
73871890|NCT02813889|147287138|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0059||||0.7624|TWO_SIDED|95.0|-0.018|0.0062||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||0.0062|-0.0180|0.7624
73951889|NCT00594932|147437479|SUPERIORITY_OR_OTHER_LEGACY||superiority|4.0|||=|0.041||||||This was the primary endpoint therefore no adjustment for multiple comparisons was necessary|Fisher Exact|||this is a categorical assessment. Prespecified. Fishers exact test. Significant is calculated as \< 0.05||||=0.041
73951890|NCT01009047|147437486|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.83||0.935|TWO_SIDED|95.0|-3.46|3.76||Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||3.76|-3.46|0.935
73979380|NCT01263496|147504438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.358|||||TWO_SIDED|95.0|-0.614|-0.103||||||||-0.103|-0.614|
73979381|NCT01263496|147504438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.432|||||TWO_SIDED|95.0|-0.69|-0.174||||||||-0.174|-0.690|
73979382|NCT01263496|147504439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.118|||||TWO_SIDED|95.0|-0.346|0.11||||||||0.110|-0.346|
73979383|NCT01263496|147504439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||||TWO_SIDED|95.0|-0.539|-0.015||||||||-0.015|-0.539|
74032932|NCT02538666|147618868|SUPERIORITY||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.72|2.49|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab + Ipilimumab over China Nivolumab||2.49|0.72|
73871891|NCT02813889|147287139|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0129||||0.0326|TWO_SIDED|95.0|0.0007|0.0251||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0251|0.0007|0.0326
73951891|NCT01009047|147437487|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.2||0.877|TWO_SIDED|95.0|-4.68|4.0||Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||4.00|-4.68|0.877
73951892|NCT01009047|147437488|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.54||0.341|TWO_SIDED|95.0|-0.55|1.59||Day 56: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||1.59|-0.55|0.341
73951893|NCT01009047|147437488|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.723|TWO_SIDED|95.0|-1.06|1.53||Day 182: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||1.53|-1.06|0.723
73951894|NCT01009047|147437489|SUPERIORITY_OR_OTHER|||||||0.351||||||Change at Day 56: Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.351
73951895|NCT01009047|147437489|SUPERIORITY_OR_OTHER|||||||0.691||||||Change at Day 182:Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.691
73979384|NCT01263496|147504439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373|||||TWO_SIDED|95.0|-0.637|-0.109||||||||-0.109|-0.637|
73979385|NCT01263496|147504439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.477|||||TWO_SIDED|95.0|-0.741|-0.213||||||||-0.213|-0.741|
73979386|NCT01263496|147504440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.181|||||TWO_SIDED|95.0|-0.416|0.055||||||||0.055|-0.416|
73979387|NCT01263496|147504440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.245|||||TWO_SIDED|95.0|-0.492|0.003||||||||0.003|-0.492|
73979388|NCT01263496|147504440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.408|||||TWO_SIDED|95.0|-0.654|-0.161||||||||-0.161|-0.654|
73979389|NCT01263496|147504440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.638|||||TWO_SIDED|95.0|-0.874|-0.402||||||||-0.402|-0.874|
73979390|NCT01263496|147504441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.51|||||TWO_SIDED|95.0|-17.56|0.54||||||||0.54|-17.56|
73979391|NCT01263496|147504441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7|||||TWO_SIDED|95.0|-19.23|-4.18||||||||-4.18|-19.23|
73979392|NCT01263496|147504441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.41|||||TWO_SIDED|95.0|-20.68|-6.15||||||||-6.15|-20.68|
73979393|NCT01263496|147504441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.38|||||TWO_SIDED|95.0|-26.93|-11.83||||||||-11.83|-26.93|
73979394|NCT01263496|147504442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||||TWO_SIDED|95.0|-12.67|3.8||||||||3.80|-12.67|
73979395|NCT01263496|147504442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.39|||||TWO_SIDED|95.0|-17.48|-1.3||||||||-1.30|-17.48|
74032933|NCT02538666|147618869|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.61|1.15|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo||1.15|0.61|
74032934|NCT02538666|147618869|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.55|1.04|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo||1.04|0.55|
74032935|NCT02538666|147618869|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.42|0.92|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo||0.92|0.42|
73979396|NCT01263496|147504442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.56|||||TWO_SIDED|95.0|-18.58|-2.54||||||||-2.54|-18.58|
73979397|NCT01263496|147504442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.37|||||TWO_SIDED|95.0|-21.44|-3.31||||||||-3.31|-21.44|
73979398|NCT01263496|147504443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||||TWO_SIDED|95.0|-15.66|1.86||||||||1.86|-15.66|
73979399|NCT01263496|147504443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|||||TWO_SIDED|95.0|-18.97|-2.49||||||||-2.49|-18.97|
73979400|NCT01263496|147504443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.21|||||TWO_SIDED|95.0|-17.2|-1.23||||||||-1.23|-17.20|
73979401|NCT01263496|147504443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.49|||||TWO_SIDED|95.0|-24.27|-6.72||||||||-6.72|-24.27|
73979402|NCT01263496|147504444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.27|||||TWO_SIDED|95.0|-11.22|6.67||||||||6.67|-11.22|
73979403|NCT01263496|147504444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36|||||TWO_SIDED|95.0|-12.16|5.44||||||||5.44|-12.16|
73979404|NCT01263496|147504444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.43|||||TWO_SIDED|95.0|-13.3|2.44||||||||2.44|-13.30|
73979405|NCT01263496|147504444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.9|||||TWO_SIDED|95.0|-20.74|-3.06||||||||-3.06|-20.74|
73979406|NCT01263496|147504445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44|||||TWO_SIDED|95.0|-11.97|7.08||||||||7.08|-11.97|
73979407|NCT01263496|147504445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.25|||||TWO_SIDED|95.0|-15.84|3.35||||||||3.35|-15.84|
73979408|NCT01263496|147504445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.93|||||TWO_SIDED|95.0|-15.28|1.41||||||||1.41|-15.28|
73979409|NCT01263496|147504445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.73|||||TWO_SIDED|95.0|-22.67|-2.78||||||||-2.78|-22.67|
74089402|NCT02697773|147731621|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24||0.0003|TWO_SIDED|95.0|-1.33|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.33|0.0003
73979410|NCT01263496|147504446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-13.19|2.31||||||||2.31|-13.19|
73979411|NCT01263496|147504446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77|||||TWO_SIDED|95.0|-13.53|5.99||||||||5.99|-13.53|
73979412|NCT01263496|147504446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|||||TWO_SIDED|95.0|-14.36|2.67||||||||2.67|-14.36|
73979413|NCT01263496|147504446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.22|||||TWO_SIDED|95.0|-20.72|-1.73||||||||-1.73|-20.72|
73979414|NCT01263496|147504447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26|||||TWO_SIDED|95.0|-10.42|5.9||||||||5.90|-10.42|
73979415|NCT01263496|147504447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-15.64|3.84||||||||3.84|-15.64|
73979416|NCT01263496|147504447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.47|||||TWO_SIDED|95.0|-16.52|-0.42||||||||-0.42|-16.52|
73979417|NCT01263496|147504447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.47|||||TWO_SIDED|95.0|-22.18|-2.76||||||||-2.76|-22.18|
73979418|NCT01263496|147504448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-7.1|7.77||||||||7.77|-7.10|
73979419|NCT01263496|147504448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||||TWO_SIDED|95.0|-10.16|8.21||||||||8.21|-10.16|
73979420|NCT01263496|147504448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-9.71|5.95||||||||5.95|-9.71|
73979421|NCT01263496|147504448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.38|||||TWO_SIDED|95.0|-18.59|-0.18||||||||-0.18|-18.59|
73979422|NCT01263496|147504449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|||||TWO_SIDED|95.0|-10.2|6.75||||||||6.75|-10.20|
73979423|NCT01263496|147504449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-13.1|5.7||||||||5.70|-13.10|
73979424|NCT01263496|147504449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.97|||||TWO_SIDED|95.0|-12.94|5.0||||||||5.00|-12.94|
73979425|NCT01263496|147504449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.74|||||TWO_SIDED|95.0|-19.4|-0.08||||||||-0.08|-19.40|
73979426|NCT01263496|147504450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.43|||||TWO_SIDED|95.0|-11.0|6.15||||||||6.15|-11.00|
73979427|NCT01263496|147504450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.29|||||TWO_SIDED|95.0|-16.53|1.94||||||||1.94|-16.53|
73979428|NCT01263496|147504450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||||TWO_SIDED|95.0|-17.93|-0.67||||||||-0.67|-17.93|
73979429|NCT01263496|147504450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.88|||||TWO_SIDED|95.0|-21.83|-1.93||||||||-1.93|-21.83|
73979430|NCT01263496|147504451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-9.68|7.27||||||||7.27|-9.68|
73979431|NCT01263496|147504451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||||TWO_SIDED|95.0|-16.34|2.24||||||||2.24|-16.34|
73979432|NCT01263496|147504451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.86|||||TWO_SIDED|95.0|-17.47|-0.26||||||||-0.26|-17.47|
73979433|NCT01263496|147504451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.51|||||TWO_SIDED|95.0|-23.12|-3.89||||||||-3.89|-23.12|
73979434|NCT01263496|147504452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|||||TWO_SIDED|95.0|-10.09|6.8||||||||6.80|-10.09|
73979435|NCT01263496|147504452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.66|2.25||||||||2.25|-15.66|
73979436|NCT01263496|147504452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.28|||||TWO_SIDED|95.0|-16.64|0.07||||||||0.07|-16.64|
73979437|NCT01263496|147504452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.82|||||TWO_SIDED|95.0|-27.39|-10.24||||||||-10.24|-27.39|
73979438|NCT01263496|147504453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.219|0.254||||||||0.254|-0.219|
73979439|NCT01263496|147504453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|||||TWO_SIDED|95.0|0.002|0.451||||||||0.451|0.002|
73979440|NCT01263496|147504453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|0.008|0.453||||||||0.453|0.008|
73979441|NCT01263496|147504453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282|||||TWO_SIDED|95.0|0.041|0.524||||||||0.524|0.041|
73951896|NCT01009047|147437489|SUPERIORITY_OR_OTHER|||||||0.965||||||Change at Day 56: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.965
73951897|NCT01009047|147437489|SUPERIORITY_OR_OTHER|||||||0.766||||||Change at Day 182: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.766
73951898|NCT01009047|147437489|SUPERIORITY_OR_OTHER|||||||0.984||||||Change at Day 56: Uncontrolled hostility/ excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.984
73951899|NCT01009047|147437489|SUPERIORITY_OR_OTHER|||||||0.985||||||Change at Day 182: Uncontrolled Hositility/ Excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.985
73951900|NCT01009047|147437489|SUPERIORITY_OR_OTHER|||||||0.803||||||Change at Day 56: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.803
73951901|NCT01009047|147437489|SUPERIORITY_OR_OTHER|||||||0.745||||||Change at Day 182: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.745
73951902|NCT01009047|147437491|SUPERIORITY_OR_OTHER|||||||0.296||||||Generalized Cochran- Mantel- Haenszel test for row mean score differences controlling for country was used.|Cochran-Mantel-Haenszel|||||||0.296
73951903|NCT01009047|147437492|SUPERIORITY_OR_OTHER|||||||0.843||||||Change at Day 56: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA|||||||0.843
73951904|NCT01009047|147437492|SUPERIORITY_OR_OTHER|||||||0.914||||||Change at Day 182: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA|||||||0.914
73951905|NCT01009047|147437493|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.27||0.895|TWO_SIDED|95.0|-2.34|2.67||Change at Day 56: Analysis of covariance (ANCOVA) model with treatment groups(paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||2.67|-2.34|0.895
73951906|NCT01009047|147437493|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.66||0.705|TWO_SIDED|95.0|-2.64|3.89||Change at Day 182: Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||3.89|-2.64|0.705
74032936|NCT02538666|147618869|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.44|0.93|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo||0.93|0.44|
73951907|NCT01009047|147437494|SUPERIORITY_OR_OTHER|||||||0.119||||||Day 56: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel|||||||0.119
73951908|NCT01009047|147437494|SUPERIORITY_OR_OTHER|||||||0.444||||||Day 182: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel|||||||0.444
73951909|NCT01676220|147437495|NON_INFERIORITY_OR_EQUIVALENCE|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|95.0|-0.09|0.174||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.||0.174|-0.090|
73951910|NCT01676220|147437496|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89||||0.4536|TWO_SIDED|95.0|0.66|1.2|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method stratified by randomization strata of screening HbA1c (\<8.0, \>=8.0%), randomization strata of geographical region (Non-Japan; Japan).||1.20|0.66|0.4536
73951911|NCT01676220|147437497|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|95.0|-0.275|0.605||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline preinjection SMPG value and baseline preinjection SMPG value-by-visit interaction as continuous fixed covariates.||0.605|-0.275|
73951912|NCT03875911|147437510|EQUIVALENCE|ANOVA was used to analyze equivalence between arms||||||0.52|||||||ANOVA|||||||0.52
73951913|NCT03875911|147437511|EQUIVALENCE|Equivalence calculated using ANOVA||||||0.01|||||||ANOVA|||||||0.01
73951914|NCT03875911|147437512|EQUIVALENCE|Equivalence was assessed using ANOVA||||||0.25|||||||ANOVA|||||||0.25
73951915|NCT03875911|147437513|EQUIVALENCE|Equivalence determined by ANOVA||||||0.93|||||||ANOVA|||||||0.93
73951916|NCT03875911|147437514|EQUIVALENCE|Equivalence determined by ANOVA||||||0.83|||||||ANOVA|||||||0.83
73951917|NCT03875911|147437515|EQUIVALENCE|Equivalence was determined using ANOVA||||||0.54|||||||ANOVA|||||||0.54
73951918|NCT05126459|147437518|SUPERIORITY|||||||0.016||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events during sedation.||||0.016
73951919|NCT05126459|147437519|SUPERIORITY|||||||0.211||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events at 8 hours after sedation.||||0.211
73951920|NCT05126459|147437520|SUPERIORITY|||||||0.374||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.374
73951921|NCT05126459|147437521|SUPERIORITY|||||||0.55|||||||ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens.||||0.55
73951922|NCT05126459|147437522|SUPERIORITY|||||||0.16||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens 8 hours after sedation.||||0.16
73951923|NCT05126459|147437523|SUPERIORITY|||||||0.012||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens at 24 hours after sedation.||||0.012
73951924|NCT02571439|147437527|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73951925|NCT02571439|147437528|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73951926|NCT02571439|147437529|OTHER|||||||0.61|||||||Kruskal-Wallis|||||||0.61
73951927|NCT02571439|147437530|OTHER|||||||0.46|||||||Kruskal-Wallis|||||||0.46
73951928|NCT02571439|147437531|OTHER|||||||0.33|||||||Kruskal-Wallis|||||||0.33
73951929|NCT02571439|147437532|OTHER|||||||0.13|||||||Kruskal-Wallis|||||||0.13
73951930|NCT02571439|147437533|OTHER|||||||0.17|||||||Kruskal-Wallis|||||||0.17
73951931|NCT02571439|147437534|OTHER|||||||0.87|||||||Kruskal-Wallis|||||||0.87
73979442|NCT01263496|147504454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|-0.173|0.353||||||||0.353|-0.173|
73979443|NCT01263496|147504454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228|||||TWO_SIDED|95.0|-0.01|0.467||||||||0.467|-0.010|
74032937|NCT02538666|147618869|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.68|1.21|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo+Ipi over placebo||1.21|0.68|
73979444|NCT01263496|147504454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.339|||||TWO_SIDED|95.0|0.095|0.584||||||||0.584|0.095|
73979445|NCT01263496|147504454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.468|||||TWO_SIDED|95.0|0.184|0.752||||||||0.752|0.184|
73951932|NCT02571439|147437535|OTHER|||||||0.27|||||||Chi-squared|||||||0.27
73951933|NCT02571439|147437536|OTHER|||||||0.91|||||||Kruskal-Wallis|||||||0.91
73951934|NCT04496167|147437537|OTHER||Least Square Mean Treatment Difference|1.386||||0.659|TWO_SIDED|95.0|-4.804|7.577||Considered significant if p-value is less than 0.05.|MMRM||"The model included treatment, visit and interaction of treatment, visit as fixed effects, Baseline as a covariate, and repeated measures with visit/participant.~Treatment difference: EN3835 - Placebo"|Mixed Model Repeated Measures (MMRM) was performed to estimate the change from Baseline treatment effect of the adapted ASES composite score in the affected shoulder comparing EN3835 to placebo treatment.||7.577|-4.804|0.659
73951935|NCT03055832|147437604|NON_INFERIORITY|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~* Power that both endpoitns are significant, assuming independence was 0.939\^2 = 0.882 or 88.2% power."|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-3.82|3.56||||||||3.56|-3.82|
73979446|NCT01263496|147504455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|||||TWO_SIDED|95.0|0.064|0.57||||||||0.570|0.064|
73979447|NCT01263496|147504455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.511|||||TWO_SIDED|95.0|0.236|0.786||||||||0.786|0.236|
74032938|NCT02538666|147618869|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.66|1.18|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo over placebo||1.18|0.66|
73951936|NCT03055832|147437605|NON_INFERIORITY|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~* Power that both endpoitns are significant, assuming independence was 0.939\^2 = 0.882 or 88.2% power."|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.97|1.16||||||||1.16|-0.97|
73951937|NCT03055832|147437606|OTHER|A formal hypothesis was not proposed for this endpoint and therefore a power calculation was not performed. A Fisher's Exact test was performed post hoc to determine if a significant difference existed between the two arms.||||||0.12|||||||Fisher Exact|||||||0.12
73951938|NCT03055832|147437607|NON_INFERIORITY|A standard deviation of 14 was assumed based on pilot data and the non-inferiority delta was set to 7. The chosen sample size and alpha = 0.025 provides 80% power for this endpoint|Mean Difference (Net)|-3.08|STANDARD_ERROR_OF_MEAN|2.89|||TWO_SIDED|95.0|-8.75|2.59||||||All questions||2.59|-8.75|
73951939|NCT01991197|147437620|SUPERIORITY||U value|43.5||||0.648|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.648
73951940|NCT01991197|147437623|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73951941|NCT01991197|147437626|SUPERIORITY||U|29.5||||0.128|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.128
73951942|NCT01439711|147437642|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73951943|NCT01439711|147437643|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73979448|NCT01263496|147504455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.437|||||TWO_SIDED|95.0|0.19|0.685||||||||0.685|0.190|
73979449|NCT01263496|147504455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.718|||||TWO_SIDED|95.0|0.413|1.022||||||||1.022|0.413|
73979450|NCT01263496|147504456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|||||TWO_SIDED|95.0|-0.029|0.481||||||||0.481|-0.029|
73979451|NCT01263496|147504456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.358|||||TWO_SIDED|95.0|0.104|0.612||||||||0.612|0.104|
73979452|NCT01263496|147504456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.308|||||TWO_SIDED|95.0|0.076|0.54||||||||0.540|0.076|
73979453|NCT01263496|147504456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|||||TWO_SIDED|95.0|0.098|0.565||||||||0.565|0.098|
73979454|NCT01263496|147504457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.13|0.41||||||||0.410|-0.130|
73979455|NCT01263496|147504457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|||||TWO_SIDED|95.0|-0.026|0.516||||||||0.516|-0.026|
74032939|NCT02538666|147618869|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.81|1.35|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo+Ipi over placebo||1.35|0.81|
73951944|NCT02397460|147437656|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment effects on Emax following capsaicin challenge were modeled for dose dependence and were estimated on the basis of disease status for participants who were healthy or had chronic cough and received gefapixant 50 mg, gefapixant 300 mg, or placebo.||||< 0.0001
73979456|NCT01263496|147504457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.294|||||TWO_SIDED|95.0|0.035|0.552||||||||0.552|0.035|
73979457|NCT01263496|147504457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|||||TWO_SIDED|95.0|0.032|0.626||||||||0.626|0.032|
73979458|NCT01263496|147504458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|||||TWO_SIDED|95.0|-0.252|0.349||||||||0.349|-0.252|
73979459|NCT01263496|147504458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|0.138|0.703||||||||0.703|0.138|
73979460|NCT01263496|147504458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46|||||TWO_SIDED|95.0|0.178|0.742||||||||0.742|0.178|
73979461|NCT01263496|147504458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.384|||||TWO_SIDED|95.0|0.085|0.683||||||||0.683|0.085|
73979462|NCT01263496|147504459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|||||TWO_SIDED|95.0|-0.257|0.326||||||||0.326|-0.257|
73979463|NCT01263496|147504459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|||||TWO_SIDED|95.0|-0.043|0.542||||||||0.542|-0.043|
73979464|NCT01263496|147504459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|||||TWO_SIDED|95.0|-0.196|0.417||||||||0.417|-0.196|
73951945|NCT02397460|147437657|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment effects following capsaicin challenge were modeled for dose. dependence and were estimated on the basis of disease status for participants who had chronic cough and received gefapixant 50 mg, gefapixant 300 mg, or placebo.||||< 0.0001
73979465|NCT01263496|147504459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|||||TWO_SIDED|95.0|0.01|0.656||||||||0.656|0.010|
73979466|NCT01263496|147504460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.268|||||TWO_SIDED|95.0|-0.769|0.233||||||||0.233|-0.769|
73979467|NCT01263496|147504460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.349|||||TWO_SIDED|95.0|-0.156|0.855||||||||0.855|-0.156|
73951946|NCT01406717|147437672|OTHER||ANCOVA|0.0002|||||TWO_SIDED|95.0|-0.31377|0.31418||||||||0.31418|-0.31377|
73979468|NCT01263496|147504460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.297|0.577||||||||0.577|-0.297|
73979469|NCT01263496|147504460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.308|||||TWO_SIDED|95.0|-0.075|0.69||||||||0.690|-0.075|
73979470|NCT01263496|147504461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|||||TWO_SIDED|95.0|-0.367|0.928||||||||0.928|-0.367|
73979471|NCT01263496|147504461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.579|||||TWO_SIDED|95.0|-0.035|1.194||||||||1.194|-0.035|
73979472|NCT01263496|147504461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.647|||||TWO_SIDED|95.0|0.054|1.241||||||||1.241|0.054|
73979473|NCT01263496|147504461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|||||TWO_SIDED|95.0|-0.28|0.785||||||||0.785|-0.280|
73979474|NCT01263496|147504462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.246|0.646||||||||0.646|-1.246|
73979475|NCT01263496|147504462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.643|||||TWO_SIDED|95.0|-0.305|1.591||||||||1.591|-0.305|
73979476|NCT01263496|147504462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|||||TWO_SIDED|95.0|-0.599|0.888||||||||0.888|-0.599|
73979477|NCT01263496|147504462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.673|1.173||||||||1.173|-0.673|
73979478|NCT01263496|147504463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-4.462|2.562||||||||2.562|-4.462|
73979479|NCT01263496|147504463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|||||TWO_SIDED|95.0|-2.712|2.779||||||||2.779|-2.712|
73979480|NCT01263496|147504463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.273|2.073||||||||2.073|-3.273|
73979481|NCT01263496|147504463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.874|2.074||||||||2.074|-2.874|
73979482|NCT01263496|147504464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|||||TWO_SIDED|95.0|-0.14|0.458||||||||0.458|-0.140|
73979483|NCT01263496|147504464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.001|0.52||||||||0.520|-0.001|
73979484|NCT01263496|147504464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|||||TWO_SIDED|95.0|-0.126|0.398||||||||0.398|-0.126|
73979485|NCT01263496|147504464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.298|||||TWO_SIDED|95.0|0.042|0.553||||||||0.553|0.042|
73979486|NCT01263496|147504465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.92|||||TWO_SIDED|95.0|-11.82|7.99||||||||7.99|-11.82|
73951947|NCT01406717|147437673|OTHER||ANCOVA|5.898|||||TWO_SIDED|95.0|-6.7565|18.5535||||||||18.5535|-6.7565|
73979487|NCT01263496|147504465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|||||TWO_SIDED|95.0|-12.45|6.4||||||||6.40|-12.45|
73979488|NCT01263496|147504465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||||TWO_SIDED|95.0|-18.77|1.96||||||||1.96|-18.77|
73979489|NCT01263496|147504465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.96|||||TWO_SIDED|95.0|-18.35|0.44||||||||0.44|-18.35|
73979490|NCT01263496|147504466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.66|||||TWO_SIDED|95.0|-3.88|19.19||||||||19.19|-3.88|
73979491|NCT01263496|147504466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-11.41|9.24||||||||9.24|-11.41|
73979492|NCT01263496|147504466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-12.91|10.75||||||||10.75|-12.91|
73979493|NCT01263496|147504466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-11.32|9.99||||||||9.99|-11.32|
73979494|NCT01263496|147504467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||||TWO_SIDED|95.0|-7.09|16.49||||||||16.49|-7.09|
73979495|NCT01263496|147504467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||||TWO_SIDED|95.0|-8.63|11.89||||||||11.89|-8.63|
73979496|NCT01263496|147504467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||||TWO_SIDED|95.0|-13.36|7.98||||||||7.98|-13.36|
73979497|NCT01263496|147504467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0|-20.58|2.17||||||||2.17|-20.58|
73979498|NCT01263496|147504468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-11.44|9.84||||||||9.84|-11.44|
73979499|NCT01263496|147504468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|||||TWO_SIDED|95.0|-11.74|7.66||||||||7.66|-11.74|
73951948|NCT01406717|147437674|OTHER||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
73951949|NCT01406717|147437676|OTHER|||||||0.6318|||||||ANCOVA|||||||0.6318
73951950|NCT01406717|147437677|OTHER|||||||0.4887|||||||ANOVA|||||||0.4887
73951951|NCT01406717|147437678|OTHER|||||||0.3813|||||||ANOVA|||||||0.3813
73951952|NCT01406717|147437679|OTHER|||||||0.99|||||||ANOVA|||||||0.9900
73951953|NCT01406717|147437680|OTHER|||||||0.0017|||||||ANOVA|||||||0.0017
73951954|NCT01406717|147437681|OTHER|||||||0.6098|||||||Mantel Haenszel|||||||0.6098
73951955|NCT01406717|147437682|OTHER|||||||0.7324|||||||ANOVA|||||||0.7324
73951956|NCT01406717|147437683|OTHER|||||||0.2984|||||||ANOVA|||||||0.2984
73951957|NCT01168674|147437684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.57|STANDARD_DEVIATION|1.67||0.48|TWO_SIDED||||||Mixed Models Analysis||The report is of the mean MADRS difference between ziprasidone versus placebo after linear mixed regression, correcting for confounding effects of order of treatment as well as other identified potential confounders.|Linear mixed effects regression model||||0.48
73951958|NCT02584855|147437688|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and conventional disease-modifying antirheumatic drug (cDMARD) use at the time of double blind randomization.||||<0.001
73951959|NCT02584855|147437689|SUPERIORITY||Odds Ratio (OR)|-45.6|||||TWO_SIDED|95.0|-58.8|-32.3||||||Logistic regression adjusting for treatment, geographic region, and cDMARD use at the time of double-blind randomization .||-32.3|-58.8|
73951960|NCT02584855|147437692|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
73951961|NCT02584855|147437693|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
73951962|NCT02584855|147437694|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
73951963|NCT02584855|147437695|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
73951964|NCT02584855|147437696|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
73951965|NCT01012973|147437704|SUPERIORITY_OR_OTHER||CMH adjusted difference|38.3|||<|0.0001|TWO_SIDED|95.0|24.4|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as Eylea minus Sham. A positive value shows Eylea showed a higher BCVA total score compared to Sham.|Null hypothesis of difference of Eylea minus Sham of 0 was tested. In the database close after Week 24, basis for primary efficacy evaluation, 56 Sham / 96 Eylea subjects were considered as week 24 completers.||52.1|24.4|<.0001
73951966|NCT01012973|147437705|SUPERIORITY_OR_OTHER||Difference in Least square means|14.7|||<|0.0001|TWO_SIDED|95.0|10.8|18.7||As primary efficacy evaluation was significant, and this p-value was below significance level of two-sided \<.05, the fixed sequence testing did continue with next secondary endpoint.|ANOVA|ANOVA, adjusting for region and baseline BCVA category as fixed factors.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham. If primary efficacy was successful, secondary efficacy endpoints were tested in a pre-specified fixed sequence testing procedure. Change in BCVA letter score was to be tested first in this sequence.||18.7|10.8|<.0001
73951967|NCT01012973|147437706|SUPERIORITY_OR_OTHER||Difference in Least square (LS) means|-239.42|||<|0.0001|TWO_SIDED|95.0|-286.31|-192.53||As fixed sequence testing did reject nullhypothesis of change from baseline in BCVA until week 24, and this p-value was below significance level of two-sided \<.05, the fixed sequence testing did continue with next secondary endpoint.|ANCOVA|ANCOVA, stratified by region and baseline BCVA category, baseline central retinal thickness added as covariate.|The difference is calculated as Eylea minus Sham. A negative value indicates Eylea showed a higher reduction in change in central retinal thickness until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in central retinal thickness between Eylea and Sham. If primary efficacy was successful, secondary efficacy end points were to be tested in a pre-specified fixed sequence testing procedure. Change in central retinal thickness was to be tested at second place in this sequence.||-192.53|-286.31|<.0001
73951968|NCT01012973|147437707|SUPERIORITY_OR_OTHER||CMH adjusted Difference|-1.5||||0.5947|TWO_SIDED|95.0|-7.4|4.4||As fixed sequence testing did reject nullhypothesis of change from baseline in CRT until week 24, and this p-value was not below significance level of two-sided \<.05, the fixed sequence testing did end with this evaluation.|Cochran-Mantel-Haenszel|Cochrane-Mantel-Haenszel test, stratified by region and baseline BCVA category.||Nullhypothesis of no difference in development of neovascularizations between Eylea and Sham group was tested. (Any neovascularization)||4.4|-7.4|0.5947
73951969|NCT01012973|147437708|SUPERIORITY_OR_OTHER||Difference in LS means|4.2|||||TWO_SIDED|95.0|1.7|6.8|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.|||6.8|1.7|
73951970|NCT01012973|147437709|SUPERIORITY_OR_OTHER||Difference in LS Means|0.044|||||TWO_SIDED|95.0|-0.002|0.09|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.|||0.09|-0.002|
73951971|NCT01782326|147437747|NON_INFERIORITY_OR_EQUIVALENCE|Study was designed to have \>95% power to rule out a 1.15-fold increase in the rate exacerbations for QVA149 vs. salmeterol/fluticasone.|Rate Ratio|0.89|||||TWO_SIDED|95.0|0.83|0.96|||Generalized linear model||If the upper limit of the confidence interval was \<1.15 then non-inferiority of QVA149 compared to SFC could be claimed|||0.96|0.83|
73951972|NCT01782326|147437747|SUPERIORITY_OR_OTHER||Rate Ratio|0.89||||0.003|TWO_SIDED|95.0|0.83|0.96|||Generalized linear method||If non-inferiority was demonstrated, superiority of QVA149A compared to SFC in reducing exacerbation rate could be claimed if the upper limit of the same CI was less than 1.|||0.96|0.83|0.003
73951973|NCT01782326|147437748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.001|TWO_SIDED|95.0|0.78|0.91|||Regression, Cox|||||0.91|0.78|<0.001
73951974|NCT01782326|147437749|SUPERIORITY_OR_OTHER||Rate Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.91|||Generalized linear model|||||0.91|0.75|<0.001
73951975|NCT01782326|147437750|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.7|0.86|||Regression, Cox|||||0.86|0.70|<0.001
73951976|NCT01782326|147437755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.256|TWO_SIDED|95.0|0.74|1.08|||Regression, Cox|||||1.08|0.74|0.256
73951977|NCT01782326|147437756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.008|TWO_SIDED|95.0|0.69|0.95|||Regression, Cox|||||0.95|0.69|0.008
73951978|NCT01782326|147437757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.046|TWO_SIDED|95.0|0.66|1.0|||Regression, Cox|||||1.00|0.66|0.046
73951979|NCT01782326|147437758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.79|TWO_SIDED|95.0|0.38|2.1|||Regression, Cox|||||2.10|0.38|0.790
73951980|NCT01767129|147437775|SUPERIORITY||Mean Difference (Final Values)|-83.4||||0.1907|TWO_SIDED|95.0|-215.02|48.23|||ANOVA|The standard analysis of variance (ANOVA) model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The least squares (LS) mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||48.23|-215.02|0.1907
73979500|NCT01263496|147504468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-15.62|4.75||||||||4.75|-15.62|
73979501|NCT01263496|147504468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.28|||||TWO_SIDED|95.0|-23.83|-2.74||||||||-2.74|-23.83|
73979502|NCT01263496|147504469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.02|||||TWO_SIDED|95.0|-28.15|14.1||||||||14.10|-28.15|
74032940|NCT02538666|147618869|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.72|1.2|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo over placebo||1.20|0.72|
74032941|NCT02538666|147618870|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.58|1.09|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo||1.09|0.58|
73951981|NCT01767129|147437776|SUPERIORITY||Median Difference (Final Values)|-18.9||||0.388|TWO_SIDED|95.0|-65.28|27.42|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||27.42|-65.28|0.3880
73951982|NCT01767129|147437777|SUPERIORITY||Mean Difference (Final Values)|171.9||||0.7574|TWO_SIDED|95.0|-1022.79|1366.64|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||1366.64|-1022.79|0.7574
73951983|NCT01767129|147437778|SUPERIORITY||Mean Difference (Final Values)|48.8||||0.4203|TWO_SIDED|95.0|-80.63|178.3|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||178.30|-80.63|0.4203
73951984|NCT01767129|147437779|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.1067|TWO_SIDED|95.0|-2.41|0.27|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part I||0.27|-2.41|0.1067
73979503|NCT01263496|147504469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.45|||||TWO_SIDED|95.0|-23.93|13.02||||||||13.02|-23.93|
73979504|NCT01263496|147504469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||||TWO_SIDED|95.0|-35.46|-0.13||||||||-0.13|-35.46|
73979505|NCT01263496|147504469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.58|||||TWO_SIDED|95.0|-47.75|-13.41||||||||-13.41|-47.75|
73979506|NCT01263496|147504470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.45|||||TWO_SIDED|95.0|-5.18|42.09||||||||42.09|-5.18|
73979507|NCT01263496|147504470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.86|||||TWO_SIDED|95.0|-13.56|33.28||||||||33.28|-13.56|
73979508|NCT01263496|147504470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.44|||||TWO_SIDED|95.0|-30.25|15.37||||||||15.37|-30.25|
73979509|NCT01263496|147504470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-34.75|9.15||||||||9.15|-34.75|
73979510|NCT01263496|147504471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.84|||||TWO_SIDED|95.0|-13.9|25.58||||||||25.58|-13.90|
73979511|NCT01263496|147504471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.35|||||TWO_SIDED|95.0|-18.2|24.9||||||||24.90|-18.20|
73979512|NCT01263496|147504471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-26.03|18.74||||||||18.74|-26.03|
73979513|NCT01263496|147504471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.37|||||TWO_SIDED|95.0|-47.08|0.34||||||||0.34|-47.08|
73979514|NCT01263496|147504472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.97|||||TWO_SIDED|95.0|-18.77|24.71||||||||24.71|-18.77|
73979515|NCT01263496|147504472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.37|||||TWO_SIDED|95.0|-21.21|23.94||||||||23.94|-21.21|
73979516|NCT01263496|147504472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||||TWO_SIDED|95.0|-32.69|10.3||||||||10.30|-32.69|
73979517|NCT01263496|147504472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.9|||||TWO_SIDED|95.0|-56.85|-12.96||||||||-12.96|-56.85|
74032942|NCT02538666|147618870|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.5|0.92|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo||0.92|0.50|
74032943|NCT02538666|147618870|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.5|1.07|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo||1.07|0.50|
74032944|NCT02538666|147618870|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.46|0.95|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo||0.95|0.46|
74032945|NCT02538666|147618870|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.54|0.96|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo+Ipi over placebo||0.96|0.54|
73951985|NCT01767129|147437779|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.865|TWO_SIDED|95.0|-2.64|3.09|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part II||3.09|-2.64|0.8650
73951986|NCT01767129|147437779|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.0745|TWO_SIDED|95.0|-4.94|0.27|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part IV||0.27|-4.94|0.0745
73951987|NCT01767129|147437780|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.0625|TWO_SIDED|95.0|-8.1|0.24|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part 1||0.24|-8.10|0.0625
73951988|NCT01767129|147437780|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.2474|TWO_SIDED|95.0|-3.74|1.07|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part 2||1.07|-3.74|0.2474
73951989|NCT01767129|147437781|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9764|TWO_SIDED|95.0|-3.1|3.01|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||3.01|-3.10|0.9764
73979518|NCT01263496|147504473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.955|||||TWO_SIDED|95.0|0.375|1.535||||||||1.535|0.375|
73979519|NCT01263496|147504473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.358|||||TWO_SIDED|95.0|0.752|1.965||||||||1.965|0.752|
73979520|NCT01263496|147504473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||||TWO_SIDED|95.0|0.724|1.975||||||||1.975|0.724|
73979521|NCT01263496|147504473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||||TWO_SIDED|95.0|0.804|1.955||||||||1.955|0.804|
73979522|NCT01263496|147504474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.034|||||TWO_SIDED|95.0|0.344|1.723||||||||1.723|0.344|
73951990|NCT01767129|147437782|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.6359|TWO_SIDED|95.0|-9.94|6.36|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Mobility||6.36|-9.94|0.6359
73951991|NCT01767129|147437782|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.0167|TWO_SIDED|95.0|-15.2|-1.87|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Activities of Daily Living||-1.87|-15.20|0.0167
73951992|NCT01767129|147437782|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.0959|TWO_SIDED|95.0|-16.54|1.56|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Emotional Well Being||1.56|-16.54|0.0959
73951993|NCT01767129|147437782|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.5108|TWO_SIDED|95.0|-16.72|8.83|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Stigma||8.83|-16.72|0.5108
73951994|NCT01767129|147437782|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.0806|TWO_SIDED|95.0|-21.06|1.42|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Social support||1.42|-21.06|0.0806
73979523|NCT01263496|147504474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.448|||||TWO_SIDED|95.0|0.78|2.115||||||||2.115|0.780|
73979524|NCT01263496|147504474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.243|||||TWO_SIDED|95.0|0.616|1.87||||||||1.870|0.616|
73979525|NCT01263496|147504474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.481|||||TWO_SIDED|95.0|0.827|2.136||||||||2.136|0.827|
73979526|NCT01263496|147504475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-4.088|4.188||||||||4.188|-4.088|
73979527|NCT01263496|147504475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.585|||||TWO_SIDED|95.0|-3.476|6.647||||||||6.647|-3.476|
73979528|NCT01263496|147504475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.517|||||TWO_SIDED|95.0|-8.151|9.184||||||||9.184|-8.151|
73979529|NCT01263496|147504475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.277|||||TWO_SIDED|95.0|-2.191|4.744||||||||4.744|-2.191|
73979530|NCT01263496|147504476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.841|||||TWO_SIDED|95.0|0.239|1.443||||||||1.443|0.239|
73979531|NCT01263496|147504476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.304|||||TWO_SIDED|95.0|0.679|1.93||||||||1.930|0.679|
73979532|NCT01263496|147504476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.992|||||TWO_SIDED|95.0|0.4|1.585||||||||1.585|0.400|
73979533|NCT01263496|147504476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263|||||TWO_SIDED|95.0|0.674|1.853||||||||1.853|0.674|
73979534|NCT01263496|147504477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.891|||||TWO_SIDED|95.0|9.597|22.184||||||||22.184|9.597|
73979535|NCT01263496|147504477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.026|||||TWO_SIDED|95.0|12.466|23.585||||||||23.585|12.466|
73979536|NCT01263496|147504477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.838|||||TWO_SIDED|95.0|14.379|25.297||||||||25.297|14.379|
73979537|NCT01263496|147504477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.368|||||TWO_SIDED|95.0|8.677|22.06||||||||22.060|8.677|
73979538|NCT01263496|147504478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.323|||||TWO_SIDED|95.0|6.567|22.079||||||||22.079|6.567|
73979539|NCT01263496|147504478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.714|||||TWO_SIDED|95.0|14.563|26.864||||||||26.864|14.563|
73951995|NCT01767129|147437782|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.4205|TWO_SIDED|95.0|-15.66|7.03|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Cognitive impairment (Cognitions)||7.03|-15.66|0.4205
73951996|NCT01767129|147437782|SUPERIORITY||Mean Difference (Final Values)|-6.1||||0.1065|TWO_SIDED|95.0|-13.63|1.53|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Communication||1.53|-13.63|0.1065
73979540|NCT01263496|147504478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.063|||||TWO_SIDED|95.0|13.125|25.002||||||||25.002|13.125|
73871892|NCT02813889|147287140|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0309|||<|0.0001|TWO_SIDED|95.0|0.0138|0.048||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0480|0.0138|<0.0001
73871893|NCT02813889|147287141|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.017||||0.0025|TWO_SIDED|95.0|0.0045|0.0295||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0295|0.0045|0.0025
73871894|NCT02813889|147287142|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0066||||0.6782|TWO_SIDED|95.0|-0.0059|0.0191||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0191|-0.0059|0.6782
73871895|NCT02813889|147287143|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|1.064||||0.0479|TWO_SIDED|95.0|0.006|2.122||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||2.122|0.006|0.0479
73871896|NCT02813889|147287144|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.278||||0.9947|TWO_SIDED|95.0|-0.921|1.477||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||1.477|-0.921|0.9947
73871897|NCT02813889|147287145|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.835||||0.2614|TWO_SIDED|95.0|-0.274|1.945||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||1.945|-0.274|0.2614
73979541|NCT01263496|147504478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.233|||||TWO_SIDED|95.0|6.618|23.847||||||||23.847|6.618|
73979542|NCT01263496|147504479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.047|||||TWO_SIDED|95.0|1.169|14.924||||||||14.924|1.169|
73979543|NCT01263496|147504479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.95|||||TWO_SIDED|95.0|7.767|20.133||||||||20.133|7.767|
74032946|NCT02538666|147618870|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.49|0.89|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo over placebo||0.89|0.49|
73871898|NCT02813889|147287146|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|1.176||||0.0314|TWO_SIDED|95.0|0.066|2.286||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||2.286|0.066|0.0314
73951997|NCT01767129|147437782|SUPERIORITY||Mean Difference (Final Values)|-5.2||||0.4456|TWO_SIDED|95.0|-19.51|9.19|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Bodily discomfort||9.19|-19.51|0.4456
73979544|NCT01263496|147504479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.221|||||TWO_SIDED|95.0|9.191|21.251||||||||21.251|9.191|
73979545|NCT01263496|147504479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.366|||||TWO_SIDED|95.0|5.847|20.885||||||||20.885|5.847|
73979546|NCT01263496|147504480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.719|||||TWO_SIDED|95.0|1.657|13.782||||||||13.782|1.657|
73979547|NCT01263496|147504480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.978|||||TWO_SIDED|95.0|7.556|18.399||||||||18.399|7.556|
73979548|NCT01263496|147504480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.076|||||TWO_SIDED|95.0|9.808|20.345||||||||20.345|9.808|
73979549|NCT01263496|147504480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.087|||||TWO_SIDED|95.0|6.561|19.614||||||||19.614|6.561|
73979550|NCT01263496|147504481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.76|||||TWO_SIDED|95.0|-7.03|20.55||||||||20.55|-7.03|
73979551|NCT01263496|147504481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.85|||||TWO_SIDED|95.0|-1.49|25.19||||||||25.19|-1.49|
73871899|NCT02813889|147287147|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-1.074||||0.0958|TWO_SIDED|95.0|-2.255|0.1059||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.1059|-2.255|0.0958
73871900|NCT02813889|147287148|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.5248||||0.966|TWO_SIDED|95.0|-1.1243|2.1739||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||2.1739|-1.1243|0.9660
73979552|NCT01263496|147504481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.72|||||TWO_SIDED|95.0|-5.12|24.56||||||||24.56|-5.12|
73979553|NCT01263496|147504481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|95.0|-13.26|14.9||||||||14.90|-13.26|
73979554|NCT01263496|147504482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-11.11|22.91||||||||22.91|-11.11|
73871901|NCT02813889|147287149|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.4198||||0.9462|TWO_SIDED|95.0|-1.6278|0.7882||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.7882|-1.6278|0.9462
73871902|NCT02813889|147287150|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-1.0705||||0.1129|TWO_SIDED|95.0|-2.2785|0.1375||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.1375|-2.2785|0.1129
73951998|NCT01767129|147437783|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.0233|TWO_SIDED|95.0|-11.72|-1.07|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||-1.07|-11.72|0.0233
73951999|NCT01767129|147437784|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.193|TWO_SIDED|95.0|-1.39|0.31|||ANOVA|Change from Screening values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||0.31|-1.39|0.1930
73952000|NCT01767129|147437785|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0511|TWO_SIDED|95.0|-2.17|0.01|||ANOVA|Change were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Dyskinesia||0.01|-2.17|0.0511
73952001|NCT01767129|147437785|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7745|TWO_SIDED|95.0|-0.7|0.91|||ANOVA|Change were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Other symptoms||0.91|-0.70|0.7745
73952002|NCT03389893|147437786|SUPERIORITY||Geometric Mean Ratio|0.033|||<|0.001|TWO_SIDED|95.0|0.008|0.131|||ANCOVA||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator.|||0.131|0.008|<0.001
73952003|NCT03389893|147437787|SUPERIORITY||Geometric Mean Ratio|0.28||||0.019|TWO_SIDED|95.0|0.09|0.8|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 3||0.80|0.09|0.019
73952004|NCT03389893|147437787|SUPERIORITY||Geometric Mean Ratio|0.37||||0.165|TWO_SIDED|95.0|0.09|1.51|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 7||1.51|0.09|0.165
73979555|NCT01263496|147504482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57|||||TWO_SIDED|95.0|-7.21|28.35||||||||28.35|-7.21|
73979556|NCT01263496|147504482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.45|||||TWO_SIDED|95.0|-10.08|26.98||||||||26.98|-10.08|
73871903|NCT00555880|147287165|SUPERIORITY_OR_OTHER_LEGACY||Sign Statistic|3.0||||0.146|TWO_SIDED||||||Sign test||Sign test was performed per analysis plan.|||||0.1460
73871904|NCT00555880|147287166|SUPERIORITY_OR_OTHER_LEGACY||Sign statistic|2.5||||0.2266|TWO_SIDED||||||Sign test||Sign test was performed per analysis plan.|||||0.2266
73952005|NCT03389893|147437787|SUPERIORITY||Geometric Mean Ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.02|0.27|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 14||0.27|0.02|<0.001
73952006|NCT03389893|147437787|SUPERIORITY||Geometric Mean Ratio|0.07|||<|0.001|TWO_SIDED|95.0|0.02|0.25|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 21||0.25|0.02|<0.001
73952007|NCT03389893|147437787|SUPERIORITY||Geometric Mean Ratio|0.16||||0.004|TWO_SIDED|95.0|0.05|0.55|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 42||0.55|0.05|0.004
73952008|NCT03389893|147437787|SUPERIORITY||Geometric Mean Ratio|0.38||||0.216|TWO_SIDED|95.0|0.08|1.8|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 77||1.80|0.08|0.216
73952009|NCT03389893|147437787|SUPERIORITY||Geometric Mean Ratio|0.24||||0.071|TWO_SIDED|95.0|0.05|1.13|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 112||1.13|0.05|0.071
73952010|NCT03389893|147437787|SUPERIORITY||Geometric Mean Ratio|0.34||||0.022|TWO_SIDED|95.0|0.13|0.85|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||0.85|0.13|0.022
73871905|NCT00555880|147287167|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|97.9||||0.0418|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period and treatment as fixed effects, and subject within sequence as a random effect|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)|Analysis of treatment difference||||0.0418
73952011|NCT03389893|147437787|SUPERIORITY||Geometric Mean Ratio|0.25||||0.015|TWO_SIDED|95.0|0.08|0.76|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||0.76|0.08|0.015
73952012|NCT03389893|147437787|SUPERIORITY||Geometric Mean Ratio|0.14|||<|0.001|TWO_SIDED|95.0|0.04|0.41|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||0.41|0.04|<0.001
73952013|NCT03389893|147437787|SUPERIORITY||Geometric Mean Ratio|0.16||||0.006|TWO_SIDED|95.0|0.04|0.58|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||0.58|0.04|0.006
73979557|NCT01263496|147504482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.82|||||TWO_SIDED|95.0|-10.67|24.3||||||||24.30|-10.67|
73979558|NCT01263496|147504483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||||TWO_SIDED|95.0|-14.95|21.13||||||||21.13|-14.95|
73979559|NCT01263496|147504483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||||TWO_SIDED|95.0|-15.61|20.57||||||||20.57|-15.61|
73952014|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.8||||0.724|TWO_SIDED|95.0|0.23|2.82|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 3||2.82|0.23|0.724
73979560|NCT01263496|147504483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-21.0|19.68||||||||19.68|-21.00|
73979561|NCT01263496|147504483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|||||TWO_SIDED|95.0|-17.47|20.05||||||||20.05|-17.47|
73979562|NCT01263496|147504484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||||TWO_SIDED|95.0|-11.7|19.86||||||||19.86|-11.70|
73979563|NCT01263496|147504484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.94|||||TWO_SIDED|95.0|-11.14|21.03||||||||21.03|-11.14|
73979564|NCT01263496|147504484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||||TWO_SIDED|95.0|-14.42|21.73||||||||21.73|-14.42|
73979565|NCT01263496|147504484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||||TWO_SIDED|95.0|-17.24|15.89||||||||15.89|-17.24|
73979566|NCT03055988|147504517|SUPERIORITY||Adjusted mean difference|-0.537|STANDARD_ERROR_OF_MEAN|1.12||0.6331|TWO_SIDED|95.0|-2.779|1.705|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|Mixed model repeated measures (MMRM) model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation. H0: Mean change from baseline in LVEDVI for (Tiotropium + Olodaterol) = Mean change from baseline in LVEDVI for (Fluticasone propionate + Salmeterol)||1.705|-2.779|0.6331
73979567|NCT03055988|147504518|SUPERIORITY||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.036||0.9817|TWO_SIDED|95.0|-0.072|0.074|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.074|-0.072|0.9817
73979568|NCT03055988|147504519|SUPERIORITY||Adjusted mean difference|1.28|STANDARD_ERROR_OF_MEAN|1.995||0.5238|TWO_SIDED|95.0|-2.719|5.279|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||5.279|-2.719|0.5238
73979569|NCT03055988|147504520|SUPERIORITY||Adjusted mean difference|2.069|STANDARD_ERROR_OF_MEAN|1.853||0.2687|TWO_SIDED|95.0|-1.64|5.779|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||5.779|-1.640|0.2687
73979570|NCT03055988|147504521|SUPERIORITY||Adjusted mean difference|0.409|STANDARD_ERROR_OF_MEAN|1.335||0.7604|TWO_SIDED|95.0|-2.264|3.082|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||3.082|-2.264|0.7604
73979571|NCT03055988|147504522|SUPERIORITY||Adjusted mean difference|-0.32|STANDARD_ERROR_OF_MEAN|1.509||0.833|TWO_SIDED|95.0|-3.341|2.702|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||2.702|-3.341|0.8330
73979572|NCT03055988|147504523|SUPERIORITY||Adjusted mean difference|-7.957|STANDARD_ERROR_OF_MEAN|2.452||0.0019|TWO_SIDED|95.0|-12.865|-3.05|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||-3.050|-12.865|0.0019
73979573|NCT03055988|147504524|SUPERIORITY||Adjusted mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.121|0.24|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.240|0.121|<0.0001
73979574|NCT03055988|147504525|SUPERIORITY||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|0.171|0.4|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.400|0.171|<0.0001
73979575|NCT01736475|147504529|SUPERIORITY_OR_OTHER_LEGACY||Ratio of means|0.1|||<|0.0001|TWO_SIDED|95.0|0.06|0.19|||Regression, Negative binomial|||Ratio Annualized Bleeding Rate (ABR) Prophylaxis/On-demand: Prophylaxis treatment w ill be considered to be successful if the upper limit of the 95% CI for the ratio between treatment regimen does not exceed 0.5 (corresponding to a 50% reduction of the mean ABR compared to the on-demand treatment). H01: μ1 ≥0.5\*μ2 Ha1: μ1\<0.5\*μ2 w here μ1 and μ2 are the mean ABRs in on prophylaxis and on-demand, respectively||0.19|0.06|<0.0001
74032947|NCT02538666|147618870|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo+Ipi over placebo||1.01|0.60|
74032948|NCT02538666|147618870|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.53|0.89|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo over placebo||0.89|0.53|
74032949|NCT02538666|147618871|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.76|1.09|||Stratified Log Rank||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over Global placebo||1.09|0.76|
74032950|NCT02538666|147618871|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.52|1.67|||Stratified Log Rank||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab + ipilimumab over China placebo||1.67|0.52|
73952015|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.27||||0.033|TWO_SIDED|95.0|0.08|0.89|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 7||0.89|0.08|0.033
73952016|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.36||||0.073|TWO_SIDED|95.0|0.12|1.1|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 14||1.10|0.12|0.073
73952017|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.73||||0.579|TWO_SIDED|95.0|0.23|2.29|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 21||2.29|0.23|0.579
73952018|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.17||||0.003|TWO_SIDED|95.0|0.05|0.53|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 28||0.53|0.05|0.003
73952019|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.52||||0.297|TWO_SIDED|95.0|0.15|1.81|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 42||1.81|0.15|0.297
73952020|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.48||||0.326|TWO_SIDED|95.0|0.11|2.12|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 77||2.12|0.11|0.326
73952021|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.52||||0.401|TWO_SIDED|95.0|0.11|2.42|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 112||2.42|0.11|0.401
73952022|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.81||||0.705|TWO_SIDED|95.0|0.28|2.4|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||2.40|0.28|0.705
73952023|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.72||||0.538|TWO_SIDED|95.0|0.25|2.08|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||2.08|0.25|0.538
73952024|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.92||||0.892|TWO_SIDED|95.0|0.25|3.34|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||3.34|0.25|0.892
73952025|NCT03389893|147437788|SUPERIORITY||Geometric Mean Ratio|0.74||||0.624|TWO_SIDED|95.0|0.21|2.56|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||2.56|0.21|0.624
74089403|NCT02697773|147731623|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.0026|TWO_SIDED|95.0|-1.1|-0.23|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-1.10|0.0026
73952026|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-9.53||||0.019|TWO_SIDED|95.0|-17.44|-1.63|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference.)|Day 3, Lesional||-1.63|-17.44|0.019
73952027|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-1.08||||0.837|TWO_SIDED|95.0|-11.47|9.32|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7, Lesional||9.32|-11.47|0.837
73952028|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.9|TWO_SIDED|95.0|-6.98|7.92|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14, Lesional||7.92|-6.98|0.900
73952029|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-5.97||||0.13|TWO_SIDED|95.0|-13.76|1.82|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21, Lesional||1.82|-13.76|0.130
73952030|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.069|TWO_SIDED|95.0|-14.76|0.56|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28, Lesional||0.56|-14.76|0.069
73952031|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-7.99||||0.032|TWO_SIDED|95.0|-15.25|-0.73|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42, Lesional||-0.73|-15.25|0.032
73952032|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.803|TWO_SIDED|95.0|-9.37|7.28|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||7.28|-9.37|0.803
73952033|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.972|TWO_SIDED|95.0|-9.02|9.34|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112, Lesional||9.34|-9.02|0.972
73952034|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.933|TWO_SIDED|95.0|-6.66|6.12|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Lesional||6.12|-6.66|0.933
73952035|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-1.82||||0.563|TWO_SIDED|95.0|-8.1|4.45|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Lesional||4.45|-8.10|0.563
73952036|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-7.08||||0.075|TWO_SIDED|95.0|-14.88|0.73|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Lesional||0.73|-14.88|0.075
73952037|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-9.84||||0.01|TWO_SIDED|95.0|-17.19|-2.48|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Lesional||-2.48|-17.19|0.010
73871906|NCT00555880|147287168|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|91.1||||0.1928|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a one-way ANOVA model|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)|||||0.1928
73871907|NCT00555880|147287169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9479|TWO_SIDED|||||The P-value is from a 2-sample t-test for difference in mean|t-test, 2 sided|||||||0.9479
73871908|NCT00555880|147287170|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-5.7||||0.059|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl - Placebo)|Analysis of treatment||||0.0590
73871909|NCT00555880|147287171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0633|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Dizziness, Lightheadedness, and Feeling Faint-Analysis of treatment||||0.0633
73871910|NCT00555880|147287171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0191|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Problems with Vision-Analysis of treatment||||0.0191
73871911|NCT00555880|147287171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0727|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Weakness-Analysis of treatment||||0.0727
73871912|NCT00555880|147287171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.282|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Fatigue-Analysis of treatment||||0.2820
73952038|NCT03389893|147437789|SUPERIORITY||Median Difference (Final Values)|0.69||||0.805|TWO_SIDED|95.0|-4.86|6.23|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 3, Non-lesional||6.23|-4.86|0.805
73952039|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|2.36||||0.329|TWO_SIDED|95.0|-2.44|7.15|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7, Non-lesional||7.15|-2.44|0.329
73952040|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.97|TWO_SIDED|95.0|-5.39|5.6|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14, Non-lesional||5.60|-5.39|0.970
73952041|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-3.31||||0.18|TWO_SIDED|95.0|-8.18|1.56|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21, Non-lesional||1.56|-8.18|0.180
73979576|NCT01075152|147504614|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.73||||0.03|TWO_SIDED|95.0|1.06|2.82||A Lan-DeMets spending function analog of the O'Brien-Fleming boundaries was proposed to control the type-I error resulting from multiple interim analyses.|Regression, Cox||Hazard Ratio describes the risk of earlier HIV therapy in comparison to deferred HIV therapy initiation as the reference group.|"We compared the randomization arms for the primary endpoint of survival using time-to-event methods of Cox proportional hazards models by the intention-to-treat principle, based on two-sided type-I error with alpha=0.05.~The trial was statistically powered to detect a 25% relative survival benefit (15% absolute benefit) with 90% power and overall two-sided alpha=0.05 with an intended sample size of 500 participants. The trial was halted early by the Data and Safety Monitoring Board."||2.82|1.06|0.03
73979577|NCT01075152|147504615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).||||0.32
73871913|NCT00555880|147287171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Trouble Concentrating-Analysis of treatment||||0.0880
73871914|NCT00555880|147287171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6439|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Head/Neck Discomfort-Analysis of treatment||||0.6439
73871915|NCT00555880|147287174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0378|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Final systolic pressure-Analysis of treatment||||0.0378
73871916|NCT00555880|147287174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0108|TWO_SIDED||||||ANOVA|||Final diastolic pressure-Analysis of treatment||||0.0108
73871917|NCT00555880|147287176|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|92.4||||0.0296|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl - Placebo)|Analysis of treatment difference||||0.0296
73871918|NCT00555880|147287181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0342|TWO_SIDED||||||Signed Rank Test|||Analysis of treatment||||0.0342
73871919|NCT01340586|147287183|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.787|||||TWO_SIDED|90.0|0.616|1.006||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.006|0.616|
73871920|NCT01340586|147287183|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.904|||||TWO_SIDED|90.0|0.697|1.173||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.173|0.697|
73871921|NCT01340586|147287183|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.871|||||TWO_SIDED|90.0|0.723|1.049||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.049|0.723|
73871922|NCT01340586|147287185|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.187|||||TWO_SIDED|90.0|0.907|1.553||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.553|0.907|
73871923|NCT01340586|147287185|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.389|||||TWO_SIDED|90.0|1.097|1.758||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.758|1.097|
73871924|NCT01340586|147287185|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.855|||||TWO_SIDED|90.0|0.707|1.033||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.033|0.707|
73871925|NCT01340586|147287187|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.165|||||TWO_SIDED|90.0|0.88|1.543||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.543|0.880|
73871926|NCT01340586|147287187|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.357|||||TWO_SIDED|90.0|1.066|1.728||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.728|1.066|
73871927|NCT01340586|147287187|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.858|||||TWO_SIDED|90.0|0.707|1.042||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.042|0.707|
73871928|NCT03671213|147287209|SUPERIORITY|Non-inferiority is demonstrated if the 90% LB \> -10.0%. If non-inferiority was met, superiority could be tested. Superiority is demonstrated if 97.5% LB \> 0.0%.||||||||||||||||For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis|Device group differences and two-sided 90% and 97.5% confidence interval lower bounds (LB) adjusting for propensity score (PS) subclass based on PS subclass weights (ATT). Non-inferiority is demonstrated if the 90% LB \> -10.0%. Superiority is demonstrated if 97.5% LB \> 0.0%. Two-sided 97.5% LB is evaluated rather than two-sided 95.0% LB since the superiority type 1 error is split between testing superiority in terms of Month 24 CCS and then separately for a set of superiority secondary endpoints with type 1 error control maintained through the use of Hochberg approach (following demonstration of non-inferiority).|||
73952042|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.342|TWO_SIDED|95.0|-5.45|1.94|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28, Non-lesional||1.94|-5.45|0.342
73952043|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-2.17||||0.234|TWO_SIDED|95.0|-5.81|1.47|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42, Non-lesional||1.47|-5.81|0.234
73952044|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.316|TWO_SIDED|95.0|-6.27|2.07|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Non-lesional||2.07|-6.27|0.316
73952045|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-1.89||||0.276|TWO_SIDED|95.0|-5.37|1.59|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112, Non-lesional||1.59|-5.37|0.276
73952046|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.237|TWO_SIDED|95.0|-4.19|1.06|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Non-lesional||1.06|-4.19|0.237
73952047|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-3.03||||0.01|TWO_SIDED|95.0|-5.3|-0.77|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Non-lesional||-0.77|-5.30|0.010
73952048|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.77|TWO_SIDED|95.0|-3.57|2.65|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Non-lesional||2.65|-3.57|0.770
73952049|NCT03389893|147437789|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.117|TWO_SIDED|95.0|-4.84|0.56|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Non-lesional||0.56|-4.84|0.117
73979578|NCT01075152|147504616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).||||0.06
73871929|NCT00699608|147287216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.267||95.0|-2.74|0.76|||ANCOVA|ANCOVA used (fixed effects: adjusted period baseline, participant baseline, age, gender, period and treatment group; random effect: participant).||||0.76|-2.74|0.267
73871930|NCT03078556|147287233|OTHER||Ratio|1.271|||||TWO_SIDED|90.0|1.1894|1.3582|||||Ratio (B/A) of plasma DTG has been presented.|||1.3582|1.1894|
73871931|NCT03078556|147287233|OTHER||Ratio|1.0341|||||TWO_SIDED|90.0|1.0097|1.0591|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0591|1.0097|
73871932|NCT03078556|147287234|OTHER||Ratio|1.155|||||TWO_SIDED|90.0|1.0699|1.2468|||||Ratio (C/A) of plasma DTG has been presented.|||1.2468|1.0699|
73952050|NCT03389893|147437790|SUPERIORITY||Mean Difference (Final Values)|85.05||||0.085|TWO_SIDED|95.0|-12.02|182.12|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7||182.12|-12.02|0.085
73979579|NCT01075152|147504617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.98
73871933|NCT03078556|147287234|OTHER||Ratio|1.0635|||||TWO_SIDED|90.0|1.0413|1.0861|||||Ratio (C/A) of plasma 3TC has been presented.|||1.0861|1.0413|
73871934|NCT03078556|147287235|OTHER||Ratio|1.2756|||||TWO_SIDED|90.0|1.1919|1.3651|||||Ratio (B/A) of plasma DTG has been presented.|||1.3651|1.1919|
73871935|NCT03078556|147287235|OTHER||Ratio|1.0372|||||TWO_SIDED|90.0|1.0116|1.0634|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0634|1.0116|
73871936|NCT03078556|147287236|OTHER||Ratio|1.1578|||||TWO_SIDED|90.0|1.0718|1.2507|||||Ratio (C/A) of plasma DTG has been presented.|||1.2507|1.0718|
73871937|NCT03078556|147287236|OTHER||Ratio|1.0702|||||TWO_SIDED|90.0|1.0464|1.0946|||||Ratio (C/A) of plasma 3TC has been presented.|||1.0946|1.0464|
73871938|NCT03078556|147287237|OTHER||Ratio|1.2805|||||TWO_SIDED|90.0|1.189|1.379|||||Ratio (B/A) of plasma DTG has been presented.|||1.3790|1.1890|
73871939|NCT03078556|147287237|OTHER||Ratio|1.1956|||||TWO_SIDED|90.0|1.1437|1.2498|||||Ratio (B/A) of plasma 3TC has been presented.|||1.2498|1.1437|
73871940|NCT03078556|147287238|OTHER||Ratio|1.141|||||TWO_SIDED|90.0|1.0533|1.2361|||||Ratio (C/A) of plasma DTG has been presented.|||1.2361|1.0533|
73871941|NCT03078556|147287238|OTHER||Ratio|1.3176|||||TWO_SIDED|90.0|1.2616|1.376|||||Ratio (C/A) of plasma 3TC has been presented.|||1.3760|1.2616|
73871942|NCT03078556|147287239|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma DTG has been presented.|||0.000|0.000|
73952051|NCT03389893|147437790|SUPERIORITY||Mean Difference (Final Values)|-21.91||||0.733|TWO_SIDED|95.0|-149.13|105.32|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14||105.32|-149.13|0.733
73952052|NCT03389893|147437790|SUPERIORITY||Mean Difference (Final Values)|-82.5||||0.129|TWO_SIDED|95.0|-189.6|24.61|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21||24.61|-189.60|0.129
73952053|NCT03389893|147437790|SUPERIORITY||Mean Difference (Final Values)|-92.11||||0.057|TWO_SIDED|95.0|-187.11|2.89|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28||2.89|-187.11|0.057
73952054|NCT03389893|147437790|SUPERIORITY||Mean Difference (Final Values)|-48.76||||0.242|TWO_SIDED|95.0|-131.52|34.0|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42||34.00|-131.52|0.242
73952055|NCT03389893|147437790|SUPERIORITY||Mean Difference (Final Values)|-54.37||||0.262|TWO_SIDED|95.0|-150.24|41.49|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||41.49|-150.24|0.262
73952056|NCT03389893|147437790|SUPERIORITY||Mean Difference (Final Values)|-22.97||||0.546|TWO_SIDED|95.0|-99.79|53.86|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112||53.86|-99.79|0.546
73952057|NCT03389893|147437790|SUPERIORITY||Mean Difference (Final Values)|-21.8||||0.503|TWO_SIDED|95.0|-86.34|42.75|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42||42.75|-86.34|0.503
73952058|NCT03389893|147437790|SUPERIORITY||Mean Difference (Final Values)|-64.0||||0.034|TWO_SIDED|95.0|-123.01|-4.98|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42||-4.98|-123.01|0.034
73952059|NCT03389893|147437790|SUPERIORITY||Mean Difference (Final Values)|-10.29||||0.789|TWO_SIDED|95.0|-86.63|66.04|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42||66.04|-86.63|0.789
73952060|NCT03389893|147437790|SUPERIORITY||Mean Difference (Final Values)|-83.9||||0.014|TWO_SIDED|95.0|-149.82|-17.98|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42||-17.98|-149.82|0.014
73952061|NCT03389893|147437791|SUPERIORITY||Slope|-0.07||||0.86|TWO_SIDED|95.0|-0.92|0.77|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7||0.77|-0.92|0.860
73952062|NCT03389893|147437791|SUPERIORITY||Slope|-0.22||||0.488|TWO_SIDED|95.0|-0.85|0.41|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14||0.41|-0.85|0.488
73952063|NCT03389893|147437791|SUPERIORITY||Slope|-0.55||||0.144|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21||0.20|-1.30|0.144
73952064|NCT03389893|147437791|SUPERIORITY||Slope|-0.35||||0.279|TWO_SIDED|95.0|-1.0|0.3|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28||0.30|-1.00|0.279
73979580|NCT01075152|147504618|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.66||||0.04|TWO_SIDED|95.0|1.03|2.68|||Regression, Cox|||We compared the randomization arms for survival using time-to-event methods of Cox proportional hazards models.||2.68|1.03|0.04
74089404|NCT02697773|147731623|SUPERIORITY||Least Mean Square Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.22||0.0023|TWO_SIDED|95.0|-1.1|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-1.10|0.0023
73871943|NCT03078556|147287239|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.|||0.000|0.000|
73952065|NCT03389893|147437791|SUPERIORITY||Slope|-0.29||||0.461|TWO_SIDED|95.0|-1.09|0.5|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42||0.50|-1.09|0.461
73952066|NCT03389893|147437791|SUPERIORITY||Slope|-0.27||||0.345|TWO_SIDED|95.0|-0.84|0.3|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||0.30|-0.84|0.345
73952067|NCT03389893|147437791|SUPERIORITY||Slope|-0.27||||0.275|TWO_SIDED|95.0|-0.77|0.23|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112||0.23|-0.77|0.275
73979581|NCT01075152|147504619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.26|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.26
73979582|NCT01075152|147504620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.23
73871944|NCT03078556|147287240|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.004|0.0|||||Median Difference of plasma DTG has been presented.|||0.000|-0.004|
73871945|NCT03078556|147287240|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.|||0.000|0.000|
73979583|NCT01075152|147504621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||repeated measure analysis|||The overall change from baseline in Karnofsky performance status scores was compared between groups via a repeated measure analysis, unstructured covariance matrix, adjusted for baseline value.||||0.34
73871946|NCT03078556|147287241|OTHER||Median Difference (Final Values)|-0.127|||||TWO_SIDED|90.0|-0.5|0.248|||||Median Difference of plasma DTG has been presented.|||0.248|-0.500|
73871947|NCT03078556|147287241|OTHER||Median Difference (Final Values)|-0.126|||||TWO_SIDED|90.0|-0.253|-0.001|||||Median Difference of plasma 3TC has been presented.|||-0.001|-0.253|
73871948|NCT03078556|147287242|OTHER||Median Difference (Final Values)|-0.127|||||TWO_SIDED|90.0|-0.497|0.132|||||Median Difference of plasma DTG has been presented.|||0.132|-0.497|
73871949|NCT03078556|147287242|OTHER||Median Difference (Final Values)|-0.248|||||TWO_SIDED|90.0|-0.376|-0.001|||||Median Difference of plasma 3TC has been presented.|||-0.001|-0.376|
73871950|NCT03078556|147287251|OTHER||Ratio|1.2774|||||TWO_SIDED|90.0|1.1931|1.3676|||||Ratio (B/A) of plasma DTG has been presented.|||1.3676|1.1931|
73871951|NCT03078556|147287251|OTHER||Ratio|1.0475|||||TWO_SIDED|90.0|1.0185|1.0773|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0773|1.0185|
73871952|NCT03078556|147287252|OTHER||Ratio|1.1599|||||TWO_SIDED|90.0|1.0711|1.256|||||Ratio (C/A) of plasma DTG has been presented.|||1.2560|1.0711|
73871953|NCT03078556|147287252|OTHER||Ratio|1.0807|||||TWO_SIDED|90.0|1.0539|1.1081|||||Ratio (C/A) of plasma 3TC has been presented.|||1.1081|1.0539|
73952068|NCT01232556|147437829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.083||||0.708|TWO_SIDED|95.0|0.82|1.44||A one sided 0.025 level testing plan was specified with two interim analyses and final testing level at one-sided 0.023.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline Secondary International Prognostic Index (sIPI), and best response to most recent chemo therapy.|Primary null hypothesis: Equality of survival distributions. Sample size sufficient to have power 0.96 for an experimental/control hazard ratio of 0.6.||1.44|0.82|0.708
73952069|NCT01232556|147437830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.924||||0.271|TWO_SIDED|95.0|0.72|1.19||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|Second comparison in hierarchical testing strategy was used for power calculation.||1.19|0.72|0.271
73952070|NCT01232556|147437831|SUPERIORITY_OR_OTHER|||||||0.843||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.||||0.843
73979584|NCT01075152|147504622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Regression, Linear|a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance||To describe early fungicidal activity, a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance of log10 colony forming units (CFU) of Cryptococcus, per mL of CSF per day, for all participants with \>2 cultures obtained.||||0.44
74089405|NCT02697773|147731623|SUPERIORITY||Least Square Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.23||0.0002|TWO_SIDED|95.0|-1.29|-0.4|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.29|0.0002
73871954|NCT03078556|147287253|OTHER||Ratio|0.7868|||||TWO_SIDED|90.0|0.7363|0.8408|||||Ratio (B/A) of plasma DTG has been presented.|||0.8408|0.7363|
73871955|NCT03078556|147287253|OTHER||Ratio|0.967|||||TWO_SIDED|90.0|0.9442|0.9904|||||Ratio (B/A) of plasma 3TC has been presented.|||0.9904|0.9442|
73871956|NCT03078556|147287254|OTHER||Ratio|0.8658|||||TWO_SIDED|90.0|0.8021|0.9347|||||Ratio (C/A) of plasma DTG has been presented.|||0.9347|0.8021|
73871957|NCT03078556|147287254|OTHER||Ratio|0.9403|||||TWO_SIDED|90.0|0.9207|0.9604|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9604|0.9207|
73871958|NCT03078556|147287255|OTHER||Ratio|0.7859|||||TWO_SIDED|90.0|0.7318|0.844|||||Ratio (B/A) of plasma DTG has been presented.|||0.8440|0.7318|
73871959|NCT03078556|147287255|OTHER||Ratio|0.9704|||||TWO_SIDED|90.0|0.9157|1.0284|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0284|0.9157|
73871960|NCT03078556|147287256|OTHER||Ratio|0.8571|||||TWO_SIDED|90.0|0.7914|0.9282|||||Ratio (C/A) of plasma DTG has been presented.|||0.9282|0.7914|
73871961|NCT03078556|147287256|OTHER||Ratio|0.9153|||||TWO_SIDED|90.0|0.8613|0.9728|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9728|0.8613|
73871962|NCT03078556|147287257|OTHER||Ratio|1.2632|||||TWO_SIDED|90.0|1.1811|1.3511|||||Ratio (B/A) of plasma DTG has been presented.|||1.3511|1.1811|
73871963|NCT03078556|147287257|OTHER||Ratio|0.9598|||||TWO_SIDED|90.0|0.9268|0.9941|||||Ratio (B/A) of plasma 3TC has been presented.|||0.9941|0.9268|
73871964|NCT03078556|147287258|OTHER||Ratio|1.1425|||||TWO_SIDED|90.0|1.0597|1.2317|||||Ratio (C/A) of plasma DTG has been presented.|||1.2317|1.0597|
73871965|NCT03078556|147287258|OTHER||Ratio|0.9548|||||TWO_SIDED|90.0|0.9299|0.9804|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9804|0.9299|
73871966|NCT03078556|147287259|OTHER||Ratio|1.1839|||||TWO_SIDED|90.0|1.0921|1.2834|||||Ratio (B/A) of plasma DTG has been presented|||1.2834|1.0921|
73871967|NCT03078556|147287259|OTHER||Ratio|0.8874|||||TWO_SIDED|90.0|0.834|0.9443|||||Ratio (B/A) of plasma 3TC has been presented|||0.9443|0.8340|
73871968|NCT03078556|147287260|OTHER||Ratio|1.078|||||TWO_SIDED|90.0|0.9958|1.167|||||Ratio (B/A) of plasma DTG has been presented|||1.1670|0.9958|
73871969|NCT03078556|147287260|OTHER||Ratio|0.9049|||||TWO_SIDED|90.0|0.8474|0.9663|||||Ratio (B/A) of plasma 3TC has been presented|||0.9663|0.8474|
73871970|NCT03078556|147287261|OTHER||Ratio|1.1545|||||TWO_SIDED|90.0|1.0208|1.3058|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.3058|1.0208|
73871971|NCT03078556|147287261|OTHER||Ratio|0.9577|||||TWO_SIDED|90.0|0.9126|1.0049|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.0049|0.9126|
73871972|NCT03078556|147287262|OTHER||Ratio|1.3256|||||TWO_SIDED|90.0|1.1837|1.4845|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.4845|1.1837|
73871973|NCT03078556|147287262|OTHER||Ratio|0.9114|||||TWO_SIDED|90.0|0.8658|0.9593|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.9593|0.8658|
73871974|NCT03078556|147287263|OTHER||Ratio|1.1481|||||TWO_SIDED|90.0|1.0154|1.2982|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2982|1.0154|
73952071|NCT01232556|147437832|SUPERIORITY_OR_OTHER|||||||0.714||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.||||0.714
73952072|NCT01232556|147437833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.142|TWO_SIDED|95.0|0.47|1.25|||Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|DOR was not part of the formal hypothesis testing strategy.||1.25|0.47|0.142
73979585|NCT01075152|147504623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||This is the interaction p-value for CSF white cell count at randomization (implying there is a statistical difference in the outcome by arm based on this parameter).|Regression, Cox|||Pre-specified subgroups formed by baseline characteristics were compared for 26 week survival with models including an interaction term between treatment arm and subgroup.||||0.02
73979586|NCT00535626|147504643|OTHER|"To test if revision rate at 5 years is less than 10% (Ha - Alternative Hypothesis).~Note: All cases enrolled in the study had to undergo revision whether from their primary procedure or a previous revision. Based on literature, 10% is the expected rate of another revision occurring in this cohort of enrolled patients."|Revision or Pending Revision Rate|2.43|||||TWO_SIDED|90.0|1.07|5.46|||||The estimated 2.43% revision rate was obtained by the Kaplan-Meier method.|||5.46|1.07|
73979587|NCT00535626|147504644|OTHER|To test if the change from the pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
73952073|NCT01232556|147437834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.2892|TWO_SIDED|95.0|-0.02|0.06|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.||||0.06|-0.02|0.2892
73952074|NCT01232556|147437835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.11||||0.1879|TWO_SIDED|95.0|-1.52|7.74|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.||||7.74|-1.52|0.1879
73979588|NCT00535626|147504645|OTHER|To test whether the change from the pre-operative SF-36 Physical Score compared to each post-operative SF-36 Physical score is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
73979589|NCT00535626|147504645|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 month SF-36 Mental Score is statistically significant.||||||0.0139|||||||t-test, 2 sided|Paired t-test||||||0.0139
73979590|NCT00535626|147504645|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 1 year SF-36 Mental Score is statistically significant.||||||0.0254|||||||t-test, 2 sided|Paired t-test||||||0.0254
73979591|NCT00535626|147504645|OTHER|To test whether the change from the SF-36 Mental Score compared to the 2 year SF-36 Mental Score is statistically significant.||||||0.1506|||||||t-test, 2 sided|Paired t-test||||||0.1506
73979592|NCT00535626|147504645|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 year SF-36 Mental Score is statistically significant.||||||0.0936|||||||t-test, 2 sided|Paired t-test||||||0.0936
73979593|NCT00535626|147504645|OTHER|To test if the change from the pre-operative SF-36 Mental Score compared to the 4 year SF-36 Mental Score is statistically significant.||||||0.0909|||||||t-test, 2 sided|Paired t-test||||||0.0909
73871975|NCT03078556|147287263|OTHER||Ratio|0.9524|||||TWO_SIDED|90.0|0.9086|0.9983|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.9983|0.9086|
73952075|NCT01473420|147437840|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|95.0|-0.17|0.24||||||Least square (LS) mean and 95 percent confidence interval (CI) derived from an analysis of covariance (ANCOVA) model with fixed effect of treatment.||0.24|-0.17|
73952076|NCT01473420|147437841|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-2.34|STANDARD_ERROR_OF_MEAN|6.175|||TWO_SIDED|95.0|-14.51|9.82||||||LS mean and 95 percent CI derived from an ANCOVA model with fixed effect of treatment.||9.82|-14.51|
73952077|NCT01473420|147437842|SUPERIORITY_OR_OTHER|||||||0.8338|||||||Two-sample t-test|||||||0.8338
73952078|NCT01473420|147437843|SUPERIORITY_OR_OTHER|||||||0.6895|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.||||||0.6895
73952079|NCT01473420|147437844|SUPERIORITY_OR_OTHER|||||||0.9177|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.||||||0.9177
73952080|NCT04033991|147437877|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
73952081|NCT04033991|147437877|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
73952082|NCT04033991|147437878|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
73952083|NCT04033991|147437878|OTHER|||||||0.0068|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0068
73952084|NCT04033991|147437880|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
73979594|NCT00535626|147504645|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 5 year SF-36 Mental Score is statistically significant.||||||0.048|||||||t-test, 2 sided|Paired t-test||||||0.048
73979595|NCT00535626|147504648|OTHER|To test whether the change from the pre-operative LEAS Score compared to the 3 month LEAS Score is statistically significant.||||||0.0011|||||||t-test, 2 sided|Paired t-test||||||0.0011
73979596|NCT00535626|147504648|OTHER|To test whether the change from the pre-operative LEAS compared to the 1, 2 and 3 year LEAS are statistically significant.|||||<|0.0001||||||This p-value applies to pre-op to 1, 2 and 3 year intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
73952085|NCT04033991|147437880|OTHER|||||||0.0004|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0004
73952086|NCT04033991|147437881|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
73952087|NCT04033991|147437881|OTHER|||||||0.0014|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0014
73952088|NCT04033991|147437886|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
73952089|NCT04033991|147437886|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
73979597|NCT00535626|147504648|OTHER|To test whether the change from the pre-operative LEAS compared to the 4 year LEAS is statistically significant.||||||0.0002|||||||t-test, 2 sided|Paired t-test||||||0.0002
73952090|NCT04033991|147437887|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
73952091|NCT04033991|147437887|OTHER|||||||0.0094|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0094
73952092|NCT03862482|147437901|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-1.22|-0.49||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 35 Brånemark® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-0.49|-1.22|<0.05
73952093|NCT03862482|147437901|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-1.35|-0.64||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 36 Swede-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-0.64|-1.35|<0.05
73979598|NCT00535626|147504648|OTHER|To test whether the change from the pre-operative LEAS compared to the 5 year LEAS is statistically significant.||||||0.0009|||||||t-test, 2 sided|Paired t-test||||||0.0009
74032951|NCT04590937|147618872|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|98.22|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|94.89|101.67|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||101.67|94.89|
74032952|NCT04590937|147618873|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|123.08|STANDARD_ERROR_OF_MEAN|12.7|||TWO_SIDED|90.0|112.22|134.98|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||134.98|112.22|
73952094|NCT03862482|147437901|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Median Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-2.13|-1.41||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 36 Screw-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-1.41|-2.13|<0.05
73952095|NCT00738530|147437909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.336|TWO_SIDED|95.0|0.76|1.1|||Log Rank|||||1.10|0.76|0.3360
73952096|NCT00738530|147437911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0004|TWO_SIDED|95.0|0.64|0.88|||Log Rank|||||0.88|0.64|0.0004
73952097|NCT00738530|147437912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.62|0.86|||Log Rank|||||0.86|0.62|0.0002
73952098|NCT00738530|147437914|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0023|TWO_SIDED|95.0|0.66|0.92|||Log Rank|||||0.92|0.66|0.0023
73952099|NCT00738530|147437915|SUPERIORITY_OR_OTHER||Difference in response rates|19.9|||<|0.0001|TWO_SIDED|95.0|13.2|26.6|||Chi-squared|||||26.6|13.2|<.0001
73952100|NCT04179461|147437920|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the CASI was captured at clinical visits. 3. A level of statistical significance was established at \< 0.05.||||||0.52||||||Change in CASI score from V1 to V3|Wilcoxon (Mann-Whitney)|||The modified CASI score incorporates key asthma outcomes such as symptoms, healthcare utilization, and medication dose.||||0.52
74032953|NCT04590937|147618874|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|117.72|STANDARD_ERROR_OF_MEAN|9.0|||TWO_SIDED|90.0|110.57|125.34|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||125.34|110.57|
73952101|NCT04179461|147437921|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.45||||||The change in ACT score from V1 to V2 (the period between V1 and V2).|Wilcoxon (Mann-Whitney)|||||||0.45
73952102|NCT04179461|147437921|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.01||||||The change in ACT score from V1-V2 to V2-V3.|Wilcoxon (Mann-Whitney)|||||||0.01
73952103|NCT04179461|147437922|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data and the Bowker's test was used to compare categorical FEV1-FVC data. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.27||||||The Change in FEV1/FVC from Visit 1 to Visit 3|Wilcoxon (Mann-Whitney)|||||||0.27
73952104|NCT04179461|147437923|EQUIVALENCE|Intervention adherence and end of study adherence were each calculated based on the 30 days prior to end of intervention and V3, respectively, in order to assess a consistent timeframe. The paired Wilcoxon signed rank test was conducted to compare controller inhaler adherence during baseline, adherence intervention, and end of study.||||||0.17||||||Change between baseline (V1) to end of study (V3)|Wilcoxon (Mann-Whitney)|||||||0.17
73952105|NCT04707391|147437929|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup A.|Difference in percentage of participants|0.2|||||TWO_SIDED|0.95|-4.38|3.5||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.50|-4.38|
73952106|NCT04707391|147437929|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup C.|Difference in percentage of participants|0.5|||||TWO_SIDED|0.95|-4.14|3.98||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.98|-4.14|
73979599|NCT01277302|147504649|SUPERIORITY_OR_OTHER||Estimated interaction effect|0.071|STANDARD_ERROR_OF_MEAN|0.107||0.5091||||||This is the p-value of the treatment by time interaction in the longitudinal model. Analysis was not adjusted for multiple comparisons as there was only 1 comparison. p \< 0.05 (2-sided) was required for significance.|Longitudinal mixed model|The analysis was stratified by disease (BRVO or CRVO), randomization month, and randomization BCVA score category (≤35, \>35 to ≤50, or \>50 letters).||The null hypothesis was that there was no difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 treatment groups as assessed by the interaction term of treatment by time in a longitudinal model.||||0.5091
73871976|NCT03078556|147287264|OTHER||Ratio|1.3176|||||TWO_SIDED|90.0|1.175|1.4775|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.4775|1.1750|
73871977|NCT03078556|147287264|OTHER||Ratio|0.9048|||||TWO_SIDED|90.0|0.8592|0.9528|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.9528|0.8592|
73871978|NCT03078556|147287265|OTHER||Ratio|1.0808|||||TWO_SIDED|90.0|0.9527|1.2261|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2261|0.9527|
73979600|NCT01190124|147504679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning HIV-RNA levels at baseline||||<0.001
73979601|NCT01190124|147504682|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at baseline||||<0.001
73979602|NCT01190124|147504695|SUPERIORITY_OR_OTHER|||||||0.007|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 24||||0.007
73979603|NCT01190124|147504696|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 48||||0.001
73871979|NCT03078556|147287265|OTHER||Ratio|0.7097|||||TWO_SIDED|90.0|0.6474|0.7779|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.7779|0.6474|
73871980|NCT03078556|147287266|OTHER||Ratio|1.2096|||||TWO_SIDED|90.0|1.0521|1.3908|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.3908|1.0521|
73871981|NCT03078556|147287266|OTHER||Ratio|0.6826|||||TWO_SIDED|90.0|0.5861|0.795|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.7950|0.5861|
73871982|NCT03078556|147287267|OTHER||Median Difference (Final Values)|0.254|||||TWO_SIDED|90.0|0.25|0.378|||||Median Difference of plasma DTG has been presented|||0.378|0.250|
73871983|NCT03078556|147287267|OTHER||Median Difference (Final Values)|0.125|||||TWO_SIDED|90.0|0.0|0.127|||||Median Difference of plasma 3TC has been presented|||0.127|0.000|
73871984|NCT03078556|147287268|OTHER||Median Difference (Final Values)|0.126|||||TWO_SIDED|90.0|0.0|0.25|||||Median Difference of plasma DTG has been presented|||0.250|0.000|
73871985|NCT03078556|147287268|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.125|||||Median Difference of plasma 3TC has been presented|||0.125|0.000|
73871986|NCT03078556|147287269|OTHER||Median Difference (Final Values)|3.017|||||TWO_SIDED|90.0|1.872|4.496|||||Median Difference of plasma DTG has been presented|||4.496|1.872|
73871987|NCT03078556|147287269|OTHER||Median Difference (Final Values)|2.113|||||TWO_SIDED|90.0|1.5|2.751|||||Median Difference of plasma 3TC has been presented|||2.751|1.500|
73871988|NCT03078556|147287270|OTHER||Median Difference (Final Values)|2.5|||||TWO_SIDED|90.0|1.748|3.751|||||Median Difference of plasma DTG has been presented|||3.751|1.748|
73979604|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.101|||||||ANOVA|||Baseline (AM)||||0.101
73979605|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.168|||||||ANOVA|||Change at Week 1 (AM)||||0.168
73979606|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||ANOVA|||Change at Week 2 (AM)||||0.930
73979607|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.487|||||||ANOVA|||Change at Week 3 (AM)||||0.487
73979608|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.914|||||||ANOVA|||Change at Week 4 (AM)||||0.914
73979609|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.977|||||||ANOVA|||Change at Final Week (AM)||||0.977
73979610|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.109|||||||ANOVA|||Baseline (PM)||||0.109
73952107|NCT04707391|147437929|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup W.|Difference in percentage of participants|1.6|||||TWO_SIDED|0.95|-2.73|4.89||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups W at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||4.89|-2.73|
73952108|NCT04707391|147437929|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup Y.|Difference in percentage of participants|0.6|||||TWO_SIDED|0.95|-3.93|3.91||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.91|-3.93|
73952109|NCT04707391|147437930|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in the 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup A.|Difference in percentage of participants|-2.5|||||TWO_SIDED|0.95|-5.59|0.47||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||0.47|-5.59|
73952110|NCT04707391|147437930|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup C.|Difference in percentage of participants|0.1|||||TWO_SIDED|0.95|-2.76|2.94||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||2.94|-2.76|
73952111|NCT04707391|147437930|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup W.|Difference in percentage of participants|0.4|||||TWO_SIDED|0.95|-2.41|3.25||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroupsW at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.25|-2.41|
73952112|NCT04707391|147437930|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup Y.|Difference in percentage of participants|-0.8|||||TWO_SIDED|0.95|-3.62|2.09||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||2.09|-3.62|
73952113|NCT01438229|147437962|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73952114|NCT01163149|147437992|SUPERIORITY|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-302.05||||0.0285|TWO_SIDED|95.0|-626.4|-59.2||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||PLP Change from Baseline to Week 24||-59.20|-626.40|0.0285
73979611|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.291|||||||ANOVA|||Change at Week 1 (PM)||||0.291
73979612|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.984|||||||ANOVA|||Change at Week 2 (PM)||||0.984
73979613|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||ANOVA|||Change at Week 3 (PM)||||0.373
73979614|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.623|||||||ANOVA|||Change at Week 4 (PM)||||0.623
73979615|NCT00070707|147504698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.978|||||||ANOVA|||Change at Final Week (PM)||||0.978
73979616|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||Baseline (AM)||||0.023
73979617|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Change at Week 1 (AM)||||0.693
73952115|NCT01163149|147437993|SUPERIORITY|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-1.825||||0.0715|TWO_SIDED|95.0|-3.21|0.23||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group.|PPi Change from Baseline to Week 24||0.230|-3.210|0.0715
73952116|NCT01163149|147437995|SUPERIORITY||Hodges-Lehmann-Sen|-0.91||||0.3301|TWO_SIDED|95.0|-3.32|1.78||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total BMC Change from Baseline to Week 24||1.780|-3.320|0.3301
73952117|NCT01163149|147437995|SUPERIORITY||Hodges-Lehmann-Sen|1.33||||0.3827|TWO_SIDED|95.0|-1.36|3.12||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMC Change from Baseline to Week 24||3.120|-1.360|0.3827
73952118|NCT01163149|147437995|SUPERIORITY||Hodges-Lehmann-Sen|-77.1||||0.0485|TWO_SIDED|95.0|-917.44|-1.74||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMC Change from Baseline to Week 24||-1.740|-917.440|0.0485
73952119|NCT01163149|147437996|SUPERIORITY||Hodges-Lehmann-Sen|-0.0125||||0.7357|TWO_SIDED|95.0|-0.04|0.039||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total Change from Baseline to Week 24||0.0390|-0.0400|0.7357
73952120|NCT01163149|147437996|SUPERIORITY||Hodges-Lehmann-Sen|0.0255||||0.2439|TWO_SIDED|95.0|-0.009|0.041||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMD Change from Baseline to Week 24||0.0410|-0.0090|0.2439
73952121|NCT01163149|147437996|SUPERIORITY||Hodges-Lehmann-Sen|-0.0315||||0.1222|TWO_SIDED|95.0|-0.059|0.012||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMD Change from Baseline to Week 24||0.0120|-0.0590|0.1222
73952122|NCT01163149|147437997|SUPERIORITY||Hodges-Lehmann-Sen|44.0||||0.1303|TWO_SIDED|95.0|-73.0|114.0||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group|Week 24 Change from Baseline||114.0|-73.0|0.1303
73952123|NCT02040090|147438007|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We will reject the null hypothesis at the one-sided 5% significance level, and conclude that Cp \> -0.1, if the lower bound of an exact 90% binomial confidence interval (CI) exceeds0.1. A sample size of 53 in each group provides 80% power to reject the null hypothesis.|Mean Difference (Net)|-0.018|||||TWO_SIDED|90.0|-0.082|0.031||||||The null hypothesis was that Cp ≤ -0.1.||0.031|-0.082|
73952124|NCT04894903|147438024|OTHER||Odds Ratio (OR)|0.45|||<|0.001|TWO_SIDED|95.0|0.3|0.68||This is the calculated p-value. We used an alpha level of 0.05|Mixed Models Analysis|Adjusted for baseline number of gaps||||0.68|0.30|<0.001
73979618|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|||||||ANOVA|||Change at Week 2 (AM)||||0.483
73979619|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|||||||ANOVA|||Change at Week 3 (AM)||||0.088
73979620|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||ANOVA|||Change at Week 4 (AM)||||0.210
73952125|NCT04894903|147438026|OTHER||Odds Ratio (OR)|0.57||||0.29|TWO_SIDED|95.0|0.2|1.62|||Mixed Models Analysis|||||1.62|0.20|0.29
73952126|NCT04894903|147438027|OTHER||beta coefficient|-0.04||||0.74|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|||||0.17|-0.24|0.74
73952127|NCT04894903|147438028|OTHER||beta coefficient|-0.04||||0.88|TWO_SIDED|95.0|-0.6|0.51|||Mixed Models Analysis|||||0.51|-0.60|0.88
73952128|NCT04894903|147438029|OTHER||beta coefficient|-1.24||||0.21|TWO_SIDED|95.0|-3.19|0.71|||Mixed Models Analysis|||||0.71|-3.19|0.21
73952129|NCT04894903|147438032|OTHER||beta coefficient|0.47||||0.21|TWO_SIDED|95.0|-0.27|1.22|||Mixed Models Analysis|||||1.22|-0.27|0.21
73952130|NCT01923428|147438045|SUPERIORITY||Risk Difference (RD)|27.0|||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73979621|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178|||||||ANOVA|||Change at Final Week (AM)||||0.178
73979622|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055|||||||ANOVA|||Baseline (PM)||||0.055
73979623|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.915|||||||ANOVA|||Change at Week 1 (PM)||||0.915
73979624|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.471|||||||ANOVA|||Change at Week 2 (PM)||||0.471
73979625|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||ANOVA|||Change at Week 3 (PM)||||0.110
73979626|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305|||||||ANOVA|||Change at Week 4 (PM)||||0.305
73979627|NCT00070707|147504699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.461|||||||ANOVA|||Change at Final Week (PM)||||0.461
73871989|NCT03078556|147287270|OTHER||Median Difference (Final Values)|1.503|||||TWO_SIDED|90.0|0.998|2.252|||||Median Difference of plasma 3TC has been presented|||2.252|0.998|
73979628|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|||||||ANOVA|||Baseline (AM)||||0.068
73979629|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||ANOVA|||Change at Week 1 (AM)||||0.116
73979630|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.749|||||||ANOVA|||Change at Week 2 (AM)||||0.749
73979631|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.289|||||||ANOVA|||Change at Week 3 (AM)||||0.289
73979632|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.982|||||||ANOVA|||Change at Week 4 (AM)||||0.982
73979633|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.941|||||||ANOVA|||Change at Final Week (AM)||||0.941
73979634|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128|||||||ANOVA|||Baseline (PM)||||0.128
73979635|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484|||||||ANOVA|||Change at Week 1 (PM)||||0.484
73979636|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|||||||ANOVA|||Change at Week 2 (PM)||||0.673
73979637|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||ANOVA|||Change at Week 3 (PM)||||0.250
73979638|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||ANOVA|||Change at Week 4 (PM)||||0.450
73979639|NCT00070707|147504700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.774|||||||ANOVA|||Change at Final Week (PM)||||0.774
73979640|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078|||||||ANOVA|||Baseline (AM)||||0.078
73871990|NCT03078556|147287279|OTHER||Ratio|1.0849|||||TWO_SIDED|90.0|0.9613|1.2245|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2245|0.9613|
73952131|NCT02550873|147438046|SUPERIORITY||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|0.72||0.0014|TWO_SIDED|90.0|1.1|3.5||a priori threshold for statistical significance = 0.10|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||"The sample size calculation was based on the following assumptions:~Normal distribution Homogeneity of variance the same in both arms, and for both types of patients Randomization ratio PRM-151:placebo = 2:1 Expected value for patients on pirfenidone or nintedanib = -1.5 Expected value for patients on no other treatment = -3 Expected value for patients on PRM-151 ≥ 0.75 Standard deviation = 5 75% of patients on a stable dose of pirfenidone or nintedanib α=0.10 two-sided Power = 80%"||3.5|1.1|0.0014
73952132|NCT02550873|147438047|SUPERIORITY||Mean Difference (Net)|31.3|STANDARD_ERROR_OF_MEAN|8.42||0.0002|TWO_SIDED|90.0|17.4|45.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.||||45.1|17.4|0.0002
73952133|NCT02550873|147438048|SUPERIORITY||Mean Difference (Net)|93.5|STANDARD_ERROR_OF_MEAN|72.98||0.2032|TWO_SIDED|90.0|-27.7|214.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.||||214.7|-27.7|0.2032
73952134|NCT02550873|147438049|SUPERIORITY||Mean Difference (Net)|31.9|STANDARD_ERROR_OF_MEAN|46.33||0.4927|TWO_SIDED|90.0|-45.0|108.8||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||108.8|-45.0|0.4927
73952135|NCT02550873|147438050|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.96||0.5835|TWO_SIDED|90.0|-2.2|4.3||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||4.3|-2.2|0.5835
73952136|NCT02550873|147438051|SUPERIORITY||Mean Difference (Net)|43.6|STANDARD_ERROR_OF_MEAN|102.28||0.6707|TWO_SIDED|90.0|-126.3|213.5||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||213.5|-126.3|0.6707
73952137|NCT02550873|147438052|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.91||0.52|TWO_SIDED|90.0|-4.4|1.9||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||1.9|-4.4|0.52
73952138|NCT02550873|147438053|OTHER|Correlation analysis||||||0.0001||||||This study was not powered to test hypotheses beyond the primary endpoint.|Pearson's correlation|||||||0.0001
73952139|NCT02550873|147438053|OTHER|Correlation analysis||||||0.0069|||||||Pearson's correlation|||This study was not powered to test hypotheses beyond the primary endpoint.||||0.0069
73952140|NCT02550873|147438054|SUPERIORITY|||||||0.4179||||||P-Value for decline in % Predicted FVC ≥ 5%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.4179
73952141|NCT02550873|147438054|SUPERIORITY|||||||0.2184||||||P-Value for decline in % predicted FVC ≥ 10%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.2184
73979641|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492|||||||ANOVA|||Change at Week 1 (AM)||||0.492
74089406|NCT02697773|147731623|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.35|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.35|<.0001
73871991|NCT03078556|147287279|OTHER||Ratio|0.9363|||||TWO_SIDED|90.0|0.8913|0.9836|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.9836|0.8913|
73952142|NCT02550873|147438055|SUPERIORITY|||||||0.7773||||||P-Value for decline in FVC ≥ 100 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.7773
73952143|NCT02550873|147438055|SUPERIORITY|||||||0.5976||||||P-Value for decline in FVC ≥ 200 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.5976
73979642|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.945|||||||ANOVA|||Change at Week 2 (AM)||||0.945
73979643|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|||||||ANOVA|||Change at Week 3 (AM)||||0.359
73979644|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.802|||||||ANOVA|||Change at Week 4 (AM)||||0.802
73979645|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.716|||||||ANOVA|||Change at Final Week (AM)||||0.716
73979646|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||ANOVA|||Baseline (PM)||||0.158
73871992|NCT03078556|147287280|OTHER||Median Difference (Final Values)|1.2477|||||TWO_SIDED|90.0|1.1013|1.4136|||||Median Difference of plasma DTG has been presented|||1.4136|1.1013|
73871993|NCT03078556|147287280|OTHER||Median Difference (Final Values)|0.8836|||||TWO_SIDED|90.0|0.8351|0.935|||||Median Difference of plasma 3TC has been presented|||0.9350|0.8351|
73871994|NCT03078556|147287281|OTHER||Ratio|0.8661|||||TWO_SIDED|90.0|0.7658|0.9796|||||Ratio (Bfed/B) of plasma DTG has been presented|||0.9796|0.7658|
73871995|NCT03078556|147287281|OTHER||Ratio|1.0442|||||TWO_SIDED|90.0|0.9951|1.0957|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.0957|0.9951|
73952144|NCT02550873|147438056|SUPERIORITY|||||||0.29||||||P-Value for increase in % predicted FVC ≥ 5%. P-Value for an increase in % predicted FVC ≥ 10% not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.29
73952145|NCT02550873|147438057|SUPERIORITY|||||||0.0508||||||P-Value for increase in FVC ≥ 100 mL. P-Value for increase in FVC ≥ 200 mL not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.0508
73952146|NCT02550873|147438058|SUPERIORITY|||||||0.6308||||||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.6308
73952147|NCT02550873|147438059|SUPERIORITY|||||||0.1846||||||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.1846
73952148|NCT02550873|147438060|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.31||0.7424|TWO_SIDED|90.0|-2.6|1.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.||||1.7|-2.6|0.7424
73952149|NCT02550873|147438070|SUPERIORITY||Mean Difference (Net)|114.6|STANDARD_DEVIATION|56.1||0.0416|TWO_SIDED|90.0|22.2|207.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.||||207.1|22.2|0.0416
73979647|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.281|||||||ANOVA|||Change at Week 1 (PM)||||0.281
73979648|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.901|||||||ANOVA|||Change at Week 2 (PM)||||0.901
73979649|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.433|||||||ANOVA|||Change at Week 3 (PM)||||0.433
74032954|NCT04590937|147618875|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|170.29|STANDARD_ERROR_OF_MEAN|25.6|||TWO_SIDED|90.0|143.73|201.76|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||201.76|143.73|
73952150|NCT01607411|147438103|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.59|||<|0.0001|TWO_SIDED|95.0|3.6|7.58||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||7.58|3.60|<0.0001
73952151|NCT01607411|147438103|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.36|||<|0.0001|TWO_SIDED|95.0|2.37|6.35||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||6.35|2.37|<0.0001
73979650|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||ANOVA|||Change at Week 4 (PM)||||0.730
74089407|NCT02697773|147731623|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.0066|TWO_SIDED|95.0|-1.11|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.11|0.0066
73979651|NCT00070707|147504701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.819|||||||ANOVA|||Change at Final Week (PM)||||0.819
73979652|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629|||||||ANOVA|||Baseline (AM)||||0.629
73979653|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||ANOVA|||Change at Week 1 (AM)||||0.038
73979654|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.182|||||||ANOVA|||Change at Week 2 (AM)||||0.182
73979655|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.149|||||||ANOVA|||Change at Week 3 (AM)||||0.149
73979656|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||ANOVA|||Change at Week 4 (AM)||||0.035
73979657|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|||||||ANOVA|||Change at Final Week (AM)||||0.056
73979658|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.711|||||||ANOVA|||Baseline (PM)||||0.711
73979659|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098|||||||ANOVA|||Change at Week 1 (PM)||||0.098
73979660|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.356|||||||ANOVA|||Change at Week 2 (PM)||||0.356
73979661|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529|||||||ANOVA|||Change at Week 3 (PM)||||0.529
73979662|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617|||||||ANOVA|||Change at Week 4 (PM)||||0.617
74032955|NCT04590937|147618876|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|91.42|STANDARD_ERROR_OF_MEAN|5.6|||TWO_SIDED|90.0|88.04|94.93|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||94.93|88.04|
74032956|NCT04590937|147618877|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|139.03|STANDARD_ERROR_OF_MEAN|16.9|||TWO_SIDED|90.0|124.29|155.51|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||155.51|124.29|
73871996|NCT03078556|147287282|OTHER||Ratio|0.7544|||||TWO_SIDED|90.0|0.6736|0.8448|||||Ratio (Cfed/C) of plasma DTG has been presented|||0.8448|0.6736|
73952152|NCT01607411|147438103|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.16||||0.0021|TWO_SIDED|95.0|1.17|5.15||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||5.15|1.17|0.0021
73952153|NCT01607411|147438104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.23||||0.2225|TWO_SIDED|95.0|-0.76|3.22||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||3.22|-0.76|0.2225
73952154|NCT01607411|147438104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.44||||0.0168|TWO_SIDED|95.0|0.44|4.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||4.43|0.44|0.0168
73952155|NCT01607411|147438104|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.2||||0.2352|TWO_SIDED|95.0|-0.79|3.19||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||3.19|-0.79|0.2352
73952156|NCT01607411|147438105|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|34.65|||<|0.0001|TWO_SIDED|95.0|30.07|39.24||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||39.24|30.07|<0.0001
73952157|NCT01607411|147438105|SUPERIORITY_OR_OTHER||Adjusted Mean difference|34.86|||<|0.0001|TWO_SIDED|95.0|30.28|39.44||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||39.44|30.28|<0.0001
73952158|NCT01607411|147438105|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|28.55|||<|0.0001|TWO_SIDED|95.0|23.97|33.13||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||33.13|23.97|< 0.0001
73952159|NCT01607411|147438105|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21||||0.9292|TWO_SIDED|95.0|-4.79|4.38||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||4.38|-4.79|0.9292
73979663|NCT00070707|147504702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|||||||ANOVA|||Change at Final Week (PM)||||0.422
73979664|NCT00070707|147504703|SUPERIORITY_OR_OTHER_LEGACY|Baseline||||||0.532|||||||Cochran-Mantel-Haenszel|||||||0.532
73979665|NCT00070707|147504703|SUPERIORITY_OR_OTHER_LEGACY|Day 15||||||0.739|||||||Cochran-Mantel-Haenszel|||||||0.739
73979666|NCT00070707|147504703|SUPERIORITY_OR_OTHER_LEGACY|Day 29||||||0.227|||||||Cochran-Mantel-Haenszel|||||||0.227
73979667|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|||||||ANOVA|||Baseline (AM)||||0.104
73979668|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||ANOVA|||Change at Week 1 (AM)||||0.022
74089408|NCT02697773|147731623|SUPERIORITY||Least Square Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.23||0.1506|TWO_SIDED|95.0|-0.79|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.79|0.1506
73871997|NCT03078556|147287282|OTHER||Ratio|1.0972|||||TWO_SIDED|90.0|1.0424|1.155|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.1550|1.0424|
73871998|NCT03078556|147287285|OTHER||Ratio|0.8654|||||TWO_SIDED|90.0|0.7629|0.9816|||||Ratio (Bfed/B) of plasma DTG has been presented|||0.9816|0.7629|
73979669|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANOVA|||Change at Week 2 (AM)||||0.012
73979670|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)||||0.001
73979671|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033|||||||ANOVA|||Change at Week 4 (AM)||||0.033
73979672|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||ANOVA|||Change at Final Week (AM)||||0.047
73979673|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.269|||||||ANOVA|||Baseline (PM)||||0.269
73979674|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.308|||||||ANOVA|||Change at Week 1 (PM)||||0.308
73979675|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||ANOVA|||Change at Week 2 (PM)||||0.050
73979676|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 3 (PM)||||0.014
73979677|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||ANOVA|||Change at Week 4 (PM)||||0.100
73952160|NCT01607411|147438105|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.1||||0.0094|TWO_SIDED|95.0|1.52|10.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||10.69|1.52|0.0094
73952161|NCT01607411|147438105|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.31||||0.0073|TWO_SIDED|95.0|1.72|10.89||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||10.89|1.72|0.0073
73952162|NCT01607411|147438106|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.78|||<|0.0001|TWO_SIDED|95.0|0.58|0.98||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random factor|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.98|0.58|<0.0001
73952163|NCT01607411|147438106|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.79|||<|0.0001|TWO_SIDED|95.0|0.58|0.99||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.99|0.58|<0.0001
73952164|NCT01607411|147438106|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.29|0.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.69|0.29|< 0.0001
73952165|NCT01607411|147438106|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.005||||0.9631|TWO_SIDED|95.0|-0.21|0.2||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.20|-0.21|0.9631
73871999|NCT03078556|147287285|OTHER||Ratio|1.0841|||||TWO_SIDED|90.0|0.9139|1.286|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.2860|0.9139|
73952166|NCT01607411|147438106|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.29||||0.0047|TWO_SIDED|95.0|0.09|0.49||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.49|0.09|0.0047
73979678|NCT00070707|147504704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.139|||||||ANOVA|||Change at Final Week (PM)||||0.139
73979679|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136|||||||ANOVA|||Baseline (AM)||||0.136
73952167|NCT01607411|147438106|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.50|0.10|0.0040
73952168|NCT00519636|147438125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.24|<|0.001||95.0|-1.3|-0.3|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo.|FFNS combined across treatment arms 1 (FFNS/FPNS) \& 2 (Placebo FF/FP) compared with Placebo FFNS combined across treatment arms 1 (FFNS/FPNS) \& 2 (Placebo FF/FP).||-0.3|-1.3|<0.001
73952169|NCT00519636|147438125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.014||95.0|-1.1|-0.1|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo.|FPNS combined across treatment arms 1 (FPNS/FFNS) \& 2 (Placebo FP/FF) compared with Placebo FPNS combined across treatment arms 1 (FPNS/FFNS)\& 2 (Placebo FP/FF).||-0.1|-1.1|0.014
73952170|NCT00519636|147438126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximate to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.||||||<0.001
73952171|NCT00462644|147438173|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
73979680|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.126|||||||ANOVA|||Change at Week 1 (AM)||||0.126
73979681|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.107|||||||ANOVA|||Change at Week 2 (AM)||||0.107
73979682|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||ANOVA|||Change at Week 3 (AM)||||0.006
73979683|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||ANOVA|||Change at Week 4 (AM)||||0.030
73872000|NCT03078556|147287286|OTHER||Ratio|0.7657|||||TWO_SIDED|90.0|0.6702|0.8749|||||Ratio (Cfed/C) of plasma DTG has been presented|||0.8749|0.6702|
73979684|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|||Change at Final Week (AM)||||0.037
73979685|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146|||||||ANOVA|||Baseline (PM)||||0.146
73979686|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.426|||||||ANOVA|||Change at Week 1 (PM)||||0.426
73872001|NCT03078556|147287286|OTHER||Ratio|1.197|||||TWO_SIDED|90.0|1.0869|1.3182|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.3182|1.0869|
73872002|NCT03078556|147287287|OTHER||Ratio|1.2929|||||TWO_SIDED|90.0|1.1281|1.4819|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.4819|1.1281|
73872003|NCT03078556|147287287|OTHER||Ratio|1.2015|||||TWO_SIDED|90.0|1.1074|1.3036|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.3036|1.1074|
73872004|NCT03078556|147287288|OTHER||Ratio|1.469|||||TWO_SIDED|90.0|1.3009|1.6588|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.6588|1.3009|
73952172|NCT00462644|147438174|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||||||0.011
73952173|NCT00462644|147438175|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
73952174|NCT00462644|147438176|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||Normality was tested using the Kolmogorow-Smirnov test.||||0.022
73952175|NCT00462644|147438177|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
73952176|NCT00462644|147438178|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73952177|NCT00904150|147438195|SUPERIORITY_OR_OTHER|||||||0.513|||||||Chi-squared|||Statistical analysis is of the distribution of PR PROGINS polymorphism frequencies between groups||||0.513
73979687|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259|||||||ANOVA|||Change at Week 2 (PM)||||0.259
73979688|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|||||||ANOVA|||Change at Week 3 (PM)||||0.026
73979689|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||ANOVA|||Change at Week 4 (PM)||||0.022
73979690|NCT00070707|147504705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||ANOVA|||Change at Final Week (PM)||||0.043
73952178|NCT00904150|147438196|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 G594a polymorphism frequencies between groups||||0.75
73952179|NCT00904150|147438197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.434||||0.002743||95.0|0.24|0.75|||Chi-squared|||Analysis of distribution of TNF genotype frequencies between groups||0.75|0.24|0.002743
73952180|NCT00904150|147438198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.02462||95.0|0.49|0.95|||Chi-squared|||Analysis of distribution of SYNE1 genotype frequencies between groups||0.95|0.49|0.02462
73952181|NCT00904150|147438199|SUPERIORITY_OR_OTHER|||||||0.18|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 C325G polymorphism frequencies between groups||||0.18
73952182|NCT00904150|147438200|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
73952183|NCT00904150|147438201|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
73952184|NCT01682538|147438213|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.858|||||TWO_SIDED|90.0|0.81|0.91|||ANOVA|||||0.91|0.81|
73979691|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||ANOVA|||Baseline (AM)||||0.181
73979692|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)||||0.014
73979693|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)||||0.004
73872005|NCT03078556|147287288|OTHER||Ratio|1.1935|||||TWO_SIDED|90.0|1.1142|1.2785|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.2785|1.1142|
73872006|NCT00570310|147287326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.003||90.0|-2.25|-0.6||1-sided, alpha = 0.05|ANOVA||Primary Hypothesis: In 'primary responder population', pregabalin is superior to placebo in maintaining pain control measured by change (3-day average: end of the randomization period versus end of maintenance period) in evening pain intensity.|||-0.60|-2.25|0.003
73872007|NCT00570310|147287327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.67|||<|0.001||95.0|5.26|10.08||1-sided, alpha = 0.05|ANOVA|||||10.08|5.26|<0.001
73952185|NCT01682538|147438214|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.954|||||TWO_SIDED|90.0|0.85|1.07|||ANOVA|||||1.07|0.85|
73952186|NCT01682538|147438215|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25).|Ratio of geometric means|1.013|||||TWO_SIDED|90.0|0.96|1.07|||ANOVA|||||1.07|0.96|
73952187|NCT01682538|147438216|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25)|Ratio of geometric means|0.802|||||TWO_SIDED|90.0|0.71|0.9|||ANOVA|||||0.90|0.71|
73952188|NCT00322868|147438246|SUPERIORITY_OR_OTHER|||||||0.2772|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum white cell count||||||0.2772
73952189|NCT00322868|147438247|SUPERIORITY_OR_OTHER|||||||0.2467|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum neutrophil count||||||0.2467
73952190|NCT00322868|147438248|SUPERIORITY_OR_OTHER|||||||0.0288|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in sputum percent neutrophils||||||0.0288
73952191|NCT00322868|147438249|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum active elastase||||||0.50
73952192|NCT00322868|147438250|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum TNFα||||||0.62
73952193|NCT00322868|147438251|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-1ß||||||0.50
73979694|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANOVA|||Change at Week 3 (AM)||||0.002
73979695|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|||||||ANOVA|||Change at Week 4 (AM)||||0.027
73979696|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|||||||ANOVA|||Change at Final Week (AM)||||0.069
73979697|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||ANOVA|||Baseline (PM)||||0.373
73979698|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148|||||||ANOVA|||Change at Week 1 (PM)||||0.148
73979699|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||ANOVA|||Change at Week 2 (PM)||||0.009
73979700|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|||||||ANOVA|||Change at Week 3 (PM)||||0.016
73979701|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||ANOVA|||Change at Week 4 (PM)||||0.113
73979702|NCT00070707|147504706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.173|||||||ANOVA|||Change at Final Week (PM)||||0.173
73952194|NCT00322868|147438252|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-6||||||0.55
73952195|NCT00322868|147438253|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-8||||||0.75
73952196|NCT03220737|147438267|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to co-primary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
73952197|NCT03220737|147438268|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to coprimary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval.|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
73952198|NCT03220737|147438269|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to coprimary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval.|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
73952199|NCT03220737|147438270|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|5.8|||||TWO_SIDED|96.7|2.4|7.1|||||Newcombe method of determining the difference between two independent binomial distributions|||7.1|2.4|
73952200|NCT03220737|147438271|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|4.3|||||TWO_SIDED|96.7|-0.3|6.2||||||||6.2|-0.3|
73952201|NCT03220737|147438272|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|4.5|||||TWO_SIDED|96.7|-1.1|6.4||||||||6.4|-1.1|
73952202|NCT03220737|147438273|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73952203|NCT03220737|147438274|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73952204|NCT03220737|147438275|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73952205|NCT03220737|147438279|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73952206|NCT03220737|147438280|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73952207|NCT03486899|147438301|SUPERIORITY||Odds Ratio (OR)|2.65||||0.055|TWO_SIDED|95.0|0.88|8.52|||Cochran-Mantel-Haenszel|||||8.52|0.88|0.055
73952208|NCT03486899|147438301|SUPERIORITY||Odds Ratio (OR)|1.89||||0.245|TWO_SIDED|95.0|0.61|6.27|||Cochran-Mantel-Haenszel|||||6.27|0.61|0.245
73952209|NCT03486899|147438301|SUPERIORITY||Odds Ratio (OR)|2.17||||0.129|TWO_SIDED|95.0|0.71|7.1|||Cochran-Mantel-Haenszel|||||7.10|0.71|0.129
73952210|NCT03486899|147438302|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
73952211|NCT03486899|147438302|SUPERIORITY||Odds Ratio (OR)|1.83||||0.381|TWO_SIDED|95.0|0.43|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.43|0.381
73952212|NCT03486899|147438302|SUPERIORITY||Odds Ratio (OR)|2.88||||0.079|TWO_SIDED|95.0|0.75|13.48|||Cochran-Mantel-Haenszel|||||13.48|0.75|0.079
74089409|NCT02697773|147731623|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.0021|TWO_SIDED|95.0|-1.25|-0.28|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.28|-1.25|0.0021
73952213|NCT03486899|147438303|SUPERIORITY||Odds Ratio (OR)|2.07||||0.18|TWO_SIDED|95.0|0.63|7.47|||Cochran-Mantel-Haenszel|||||7.47|0.63|0.180
73952214|NCT03486899|147438303|SUPERIORITY||Odds Ratio (OR)|1.37||||0.612|TWO_SIDED|95.0|0.38|5.2|||Cochran-Mantel-Haenszel|||||5.20|0.38|0.612
73952215|NCT03486899|147438303|SUPERIORITY||Odds Ratio (OR)|2.59||||0.079|TWO_SIDED|95.0|0.81|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.81|0.079
73952216|NCT03486899|147438304|SUPERIORITY||Odds Ratio (OR)|0.39||||0.038|TWO_SIDED|95.0|0.15|1.03|||Cochran-Mantel-Haenszel|||||1.03|0.15|0.038
73979703|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089|||||||ANOVA|||Baseline (AM)||||0.089
73952217|NCT03486899|147438304|SUPERIORITY||Odds Ratio (OR)|0.6||||0.256|TWO_SIDED|95.0|0.22|1.57|||Cochran-Mantel-Haenszel|||||1.57|0.22|0.256
73952218|NCT03486899|147438304|SUPERIORITY||Odds Ratio (OR)|0.65||||0.296|TWO_SIDED|95.0|0.25|1.73|||Cochran-Mantel-Haenszel|||||1.73|0.25|0.296
73952219|NCT03486899|147438305|SUPERIORITY||Odds Ratio (OR)|1.36||||0.718|TWO_SIDED|95.0|0.22|9.8|||Cochran-Mantel-Haenszel|||||9.80|0.22|0.718
73979704|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)||||0.014
73979705|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)||||0.004
74089410|NCT02697773|147731623|SUPERIORITY||Least Square Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.25||0.0008|TWO_SIDED|95.0|-1.32|-0.35|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.32|0.0008
74089411|NCT02697773|147731623|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.0167|TWO_SIDED|95.0|-1.09|-0.11|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.11|-1.09|0.0167
74089412|NCT02697773|147731623|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.25||0.0073|TWO_SIDED|95.0|-1.17|-0.18|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.17|0.0073
74089413|NCT02697773|147731625|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.23||0.0058|TWO_SIDED|95.0|-1.09|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.09|0.0058
73872008|NCT00887549|147287328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015|||<|0.0001|TWO_SIDED|95.0|1.008|1.021|||Regression, Cox|The Cox model, based upon participant level data, included PFS as dependent variable and TS score in the nucleus as independent variable.||||1.021|1.008|<0.0001
73952220|NCT03486899|147438305|SUPERIORITY||Odds Ratio (OR)|0.64||||0.632|TWO_SIDED|95.0|0.05|5.87|||Cochran-Mantel-Haenszel|||||5.87|0.05|0.632
73952221|NCT03486899|147438305|SUPERIORITY||Odds Ratio (OR)|0.32||||0.293|TWO_SIDED|95.0|0.01|4.19|||Cochran-Mantel-Haenszel|||||4.19|0.01|0.293
73952222|NCT03486899|147438306|SUPERIORITY||Odds Ratio (OR)|1.36||||0.718|TWO_SIDED|95.0|0.22|9.8|||Cochran-Mantel-Haenszel|||||9.80|0.22|0.718
73952223|NCT03486899|147438306|SUPERIORITY||Odds Ratio (OR)|0.64||||0.632|TWO_SIDED|95.0|0.05|5.87|||Cochran-Mantel-Haenszel|||||5.87|0.05|0.632
73952224|NCT03486899|147438306|SUPERIORITY||Odds Ratio (OR)|0.32||||0.293|TWO_SIDED|95.0|0.01|4.19|||Cochran-Mantel-Haenszel|||||4.19|0.01|0.293
74089414|NCT02697773|147731625|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.23||0.0002|TWO_SIDED|95.0|-1.31|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.31|0.0002
74089415|NCT02697773|147731625|SUPERIORITY||Least Square Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.44|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.44|<.0001
73952225|NCT03486899|147438307|SUPERIORITY||Odds Ratio (OR)|2.55||||0.101|TWO_SIDED|95.0|0.73|10.12|||Cochran-Mantel-Haenszel|||||10.12|0.73|0.101
73952226|NCT03486899|147438307|SUPERIORITY||Odds Ratio (OR)|1.43||||0.587|TWO_SIDED|95.0|0.36|6.17|||Cochran-Mantel-Haenszel|||||6.17|0.36|0.587
73952227|NCT03486899|147438307|SUPERIORITY||Odds Ratio (OR)|1.72||||0.371|TWO_SIDED|95.0|0.45|7.2|||Cochran-Mantel-Haenszel|||||7.20|0.45|0.371
73952228|NCT03486899|147438308|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
73952229|NCT03486899|147438308|SUPERIORITY||Odds Ratio (OR)|1.83||||0.381|TWO_SIDED|95.0|0.43|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.43|0.381
73952230|NCT03486899|147438308|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
73952231|NCT03486899|147438309|SUPERIORITY||Odds Ratio (OR)|2.85||||0.06|TWO_SIDED|95.0|0.83|11.21|||Cochran-Mantel-Haenszel|||||11.21|0.83|0.060
73952232|NCT03486899|147438309|SUPERIORITY||Odds Ratio (OR)|1.93||||0.276|TWO_SIDED|95.0|0.53|7.92|||Cochran-Mantel-Haenszel|||||7.92|0.53|0.276
73952233|NCT03486899|147438309|SUPERIORITY||Odds Ratio (OR)|1.72||||0.371|TWO_SIDED|95.0|0.45|7.2|||Cochran-Mantel-Haenszel|||||7.20|0.45|0.371
73952234|NCT03486899|147438310|SUPERIORITY||Odds Ratio (OR)|1.72||||0.242|TWO_SIDED|95.0|0.62|4.87|||Cochran-Mantel-Haenszel|||||4.87|0.62|0.242
73952235|NCT03486899|147438310|SUPERIORITY||Odds Ratio (OR)|1.1||||0.803|TWO_SIDED|95.0|0.37|3.26|||Cochran-Mantel-Haenszel|||||3.26|0.37|0.803
73952236|NCT03486899|147438310|SUPERIORITY||Odds Ratio (OR)|1.56||||0.35|TWO_SIDED|95.0|0.56|4.46|||Cochran-Mantel-Haenszel|||||4.46|0.56|0.350
73952237|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.031||0.79|TWO_SIDED|95.0|0.95|1.07|||fixed-effect meta-analysis|||The null hypothesis was the that proportions of patients with at least one OAC filled at one year were the same between the two groups.||1.07|0.95|0.79
73952238|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.039||0.307|TWO_SIDED|95.0|0.96|1.12|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 183 days were the same between the two groups.||1.12|0.96|0.307
73952239|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.052||0.375|TWO_SIDED|95.0|0.95|1.16|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 90 days were the same between the two groups.||1.16|0.95|0.375
73872009|NCT00900666|147287340|NON_INFERIORITY_OR_EQUIVALENCE|a priori power calculation suggested N=26 for each group.||||||0.761|TWO_SIDED|95.0||||p\<0.05 threshold|ANOVA|Correlations with walking speed and time since injury were initially performed to determine whether ANCOVA would be be more appropriate.||ANOVA||||0.761
73872010|NCT00900666|147287341|SUPERIORITY_OR_OTHER|||||||0.896||95.0|||||ANOVA|||||||.896
73872011|NCT01318408|147287348|NON_INFERIORITY_OR_EQUIVALENCE|Assessing effects on cognition over time.||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The intent-to-treat group included all individuals who initiated levetiracetam. The Mann-Whitney U test was used to determine changes in participants' scores for cognition, function, and behavior between baseline and 12 weeks.Change in MMSE test scores was the primary outcome measure.||||.01
73872012|NCT01318408|147287349|NON_INFERIORITY_OR_EQUIVALENCE|Assessing cognitive effects over time.||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Lower scores (negative change) indicate improvements on the ADAS-cog.||||||.02
73872013|NCT00377858|147287351|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.3% based on prior studies indicating an HbA1c difference of 0.6% in patients treated with lispro and sulfonylurea compared with those treated with sulfonylurea and metformin.|Mean Difference (Net)|0.17||||0.097||95.0|-0.03|0.37|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c Stratum + Sulfonylurea stratum + Country + Baseline HbA1c Stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for (Insulin Lispro Mid Mixture minus Insulin Glargine).|Assuming 15% drop-out rate after randomization, remaining 213 patients in each treatment group would allow confirmation of noninferiority with no treatment difference and a noninferiority limit of 0.3% using upper limit of 2-sided confidence interval at significance level of 0.05 with 80% power.||0.37|-0.03|0.097
73872014|NCT00377858|147287352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.047||95.0|0.0|0.33||P-value for 12 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.33|0.00|0.047
73952240|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|1.09|STANDARD_ERROR_OF_MEAN|0.076||0.265|TWO_SIDED|95.0|0.94|1.26|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 42 days were the same between the two groups.||1.26|0.94|0.265
73952241|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.044||0.237|TWO_SIDED|95.0|0.97|1.15|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among females were the same between the two groups.||1.15|0.97|0.237
74091667|NCT04168190|147737022|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|2.27|||<|0.001|TWO_SIDED|95.0|1.81|2.83|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 20A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.83|1.81|<0.001
73872015|NCT00377858|147287352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.043||95.0|0.01|0.35||P-value for 24 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.35|0.01|0.043
73872016|NCT00377858|147287352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.343||95.0|-0.1|0.29||P-value for 36 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.10|0.343
73872017|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.432||95.0||||P-value for Week 12: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.432
73872018|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||P-value for 12 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.602
73872019|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||P-value for 12 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.370
73952242|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.042||0.487|TWO_SIDED|95.0|0.89|1.05|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among males were the same between the two groups.||1.05|0.89|0.487
73952243|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.125||0.952|TWO_SIDED|95.0|0.78|1.27|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age \<= 64 yrs were the same between the two groups.||1.27|0.78|0.952
73979706|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)||||0.001
73872020|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value for 24 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.198
73872021|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-value for 24 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.636
73872022|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value for 24 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.185
73872023|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value for 36 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.393
73872024|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.739||95.0||||P-value for 36 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.739
73979707|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|||||||ANOVA|||Change at Week 4 (AM)||||0.041
73952244|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.057||0.696|TWO_SIDED|95.0|0.91|1.14|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of the patients with at least one OAC filled among age 65 - 74 yrs were the same between the two groups.||1.14|0.91|0.696
73952245|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.047||0.584|TWO_SIDED|95.0|0.94|1.13|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age 75 - 84 yrs were the same between groups.||1.13|0.94|0.584
73952246|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.069||0.911|TWO_SIDED|95.0|0.87|1.14|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age \>= 85 yrs were the same between the two groups.||1.14|0.87|0.911
73952247|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.057||0.746|TWO_SIDED|95.0|0.88|1.1|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of the patients with at least one OAC filled among those with a CHADS-VASC of 2-3 were the same between the two groups.||1.10|0.88|0.746
73952248|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.048||0.109|TWO_SIDED|95.0|0.98|1.19|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among those with a CHADS-VASC score of 4-5 were the same between the two groups.||1.19|0.98|0.109
73979708|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||ANOVA|||Change at Final Week (AM)||||0.036
73979709|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|||||||ANOVA|||Baseline (PM)||||0.170
73979710|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237|||||||ANOVA|||Change at Week 1 (PM)||||0.237
73979711|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||ANOVA|||Change at Week 2 (PM)||||0.019
74091668|NCT04168190|147737023|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|3.77|||<|0.001|TWO_SIDED|95.0|2.95|4.84|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 6A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||4.84|2.95|<0.001
73979712|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANOVA|||Change at Week 3 (PM)||||0.018
73979713|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.149|||||||ANOVA|||Change at Week 4 (PM)||||0.149
73979714|NCT00070707|147504707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|||||||ANOVA|||Change at Final Week (PM)||||0.231
73952249|NCT03259373|147438382|SUPERIORITY||Odds Ratio (OR)|0.94|STANDARD_ERROR_OF_MEAN|0.057||0.244|TWO_SIDED|95.0|0.84|1.05|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among those with a CHADS-VASC score \>=6 were the same between the two groups.||1.05|0.84|0.244
73952250|NCT03259373|147438383|SUPERIORITY||Hazard Ratio (HR)|0.92|STANDARD_ERROR_OF_MEAN|0.079||0.3|TWO_SIDED|95.0|0.79|1.08|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.08|0.79|0.300
73979715|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.745|||||||ANOVA|||Baseline (AM)||||0.745
73979716|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||ANOVA|||Change at Week 1 (AM)||||0.250
73979717|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 2 (AM)||||||0.202|||||||ANOVA|||||||0.202
73979718|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 3 (AM)||||||0.104|||||||ANOVA|||||||0.104
73979719|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 4 (AM)||||||0.348|||||||ANOVA|||||||0.348
73979720|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|Change at Final Week (AM)||||||0.355|||||||ANOVA|||||||0.355
73979721|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|Baseline (PM)||||||0.851|||||||ANOVA|||||||0.851
73979722|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 1 (PM)||||||0.993|||||||ANOVA|||||||0.993
73979723|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 2 (PM)||||||0.476|||||||ANOVA|||||||0.476
73979724|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 3 (PM)||||||0.149|||||||ANOVA|||||||0.149
73979725|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 4 (PM)||||||0.616|||||||ANOVA|||||||0.616
73979726|NCT00070707|147504708|SUPERIORITY_OR_OTHER_LEGACY|Change at Final Week (PM)||||||0.527|||||||ANOVA|||||||0.527
73979727|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||ANOVA|||Baseline (AM)||||0.116
73979728|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994|||||||ANOVA|||Change at Week 1 (AM)||||0.994
73979729|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961|||||||ANOVA|||Change at Week 2 (AM)||||0.961
73979730|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183|||||||ANOVA|||Change at Week 3 (AM)||||0.183
73979731|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||ANOVA|||Change at Week 4 (AM)||||0.440
73979732|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.838|||||||ANOVA|||Change at Final Week (AM)||||0.838
73979733|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096|||||||ANOVA|||Baseline (PM)||||0.096
73979734|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362|||||||ANOVA|||Change at Week 1 (PM)||||0.362
73979735|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Change at Week 2 (PM)||||0.693
73979736|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.603|||||||ANOVA|||Change at Week 3 (PM)||||0.603
73979737|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.579|||||||ANOVA|||Change at Week 4 (PM)||||0.579
73979738|NCT00070707|147504709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|||||||ANOVA|||Change at Final Week (PM)||||0.413
73979739|NCT00070707|147504710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.823|||||||ANOVA|||Baseline||||0.823
73979740|NCT00070707|147504710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.744|||||||ANOVA|||Change at Day 15||||0.744
73979741|NCT00070707|147504710|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675|||||||ANOVA|||Change at Day 29||||0.675
73979742|NCT00070707|147504711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Baseline||||0.693
73952251|NCT03259373|147438384|SUPERIORITY||Hazard Ratio (HR)|1.31|STANDARD_ERROR_OF_MEAN|0.172||0.122|TWO_SIDED|95.0|0.93|1.83|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.83|0.93|0.122
73952252|NCT03259373|147438385|SUPERIORITY||Hazard Ratio (HR)|0.98|STANDARD_ERROR_OF_MEAN|0.073||0.76|TWO_SIDED|95.0|0.85|1.13|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.13|0.85|0.760
73952253|NCT03259373|147438386|SUPERIORITY||Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.072||0.76|TWO_SIDED|95.0|0.86|1.14|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.14|0.86|0.760
73952254|NCT03259373|147438387|SUPERIORITY||Hazard Ratio (HR)|0.97|STANDARD_ERROR_OF_MEAN|0.052||0.616|TWO_SIDED|95.0|0.88|1.08|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.08|0.88|0.616
73952255|NCT03259373|147438388|SUPERIORITY||Hazard Ratio (HR)|1.0|STANDARD_ERROR_OF_MEAN|0.072||0.992|TWO_SIDED|95.0|0.87|1.15|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.15|0.87|0.992
73952256|NCT03259373|147438389|SUPERIORITY||Hazard Ratio (HR)|1.01|STANDARD_ERROR_OF_MEAN|0.029||0.808|TWO_SIDED|95.0|0.95|1.07|||fixed-effect meta-analysis|||||1.07|0.95|0.808
73952257|NCT03259373|147438390|SUPERIORITY||Standardized Mean Difference (%)|-0.51|STANDARD_ERROR_OF_MEAN|0.027||0.853|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.853
73952258|NCT03259373|147438391|SUPERIORITY||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.066||0.303|TWO_SIDED|95.0|0.82|1.06|||fixed-effect meta-analysis|||||1.06|0.82|0.303
73952259|NCT03259373|147438392|SUPERIORITY||Hazard Ratio (HR)|1.03|STANDARD_ERROR_OF_MEAN|0.063||0.649|TWO_SIDED|95.0|0.91|1.16|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.16|0.91|0.649
73952260|NCT03259373|147438393|SUPERIORITY||Standardized Mean Difference (%)|-0.4998|STANDARD_ERROR_OF_MEAN|0.009||0.587|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.587
73952261|NCT03259373|147438393|SUPERIORITY||Standardized Mean Difference (%)|-0.4655|STANDARD_ERROR_OF_MEAN|0.009||0.613|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.613
73952262|NCT03259373|147438393|SUPERIORITY||Standardized Mean Difference (%)|0.598|STANDARD_ERROR_OF_MEAN|0.009||0.515|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.515
73952263|NCT03259373|147438393|SUPERIORITY||Standardized Mean Difference (%)|-2.17|STANDARD_ERROR_OF_MEAN|0.009||0.018|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.018
73979743|NCT00070707|147504711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.818|||||||ANOVA|||Change at Day 15||||0.818
73979744|NCT00070707|147504711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.915|||||||ANOVA|||Change at Day 29||||0.915
73979745|NCT00070707|147504712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.823|||||||ANOVA|||Baseline||||0.823
73952264|NCT03259373|147438393|SUPERIORITY||Standardized Mean Difference (%)|0.05|STANDARD_ERROR_OF_MEAN|0.009||0.956|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.956
73952265|NCT03259373|147438394|SUPERIORITY||Standardized Mean Difference (%)|-1.018|STANDARD_ERROR_OF_MEAN|0.009||0.279|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.279
73952266|NCT03259373|147438394|SUPERIORITY||Standardized Mean Difference (%)|-1.347|STANDARD_ERROR_OF_MEAN|0.009||0.143|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.143
73952267|NCT03786094|147438446|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.445|TWO_SIDED|96.0|0.85|1.41|||t-test, 2 sided||HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.|||1.41|0.85|0.4450
73952268|NCT03786094|147438447|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6158|TWO_SIDED|96.0|0.81|1.41|||t-test, 2 sided||HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.|||1.41|0.81|0.6158
73952269|NCT03786094|147438448|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6126|TWO_SIDED|99.9|0.66|1.77|||t-test, 2 sided|||||1.77|0.66|0.6126
73952270|NCT02711826|147438459|SUPERIORITY|||||||0.425|||||||Fisher Exact|||||||0.425
73952271|NCT02711826|147438460|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||||||0.700
73952272|NCT02711826|147438461|SUPERIORITY|||||||0.201|||||||Kruskal-Wallis|||||||0.201
73952273|NCT03990363|147438516|SUPERIORITY|||||||0.0648|||||||Repeated Measures Mixed Model|||||||0.0648
73952274|NCT03990363|147438516|SUPERIORITY|||||||0.6296|||||||Repeated Measures Mixed Model|||||||0.6296
73979746|NCT00070707|147504712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|||||||ANOVA|||Change at Day 15||||0.202
73979747|NCT00070707|147504712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.199|||||||ANOVA|||Change at Day 29||||0.199
73979748|NCT00070707|147504713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.375|||||||ANOVA|||Baseline||||0.375
73979749|NCT00070707|147504713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||ANOVA|||Change at Week 1||||0.710
73979750|NCT00070707|147504713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.597|||||||ANOVA|||Change at Week 2||||0.597
73872025|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||P-value for 36 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.396
73952275|NCT03990363|147438516|SUPERIORITY|||||||0.0263|||||||Repeated Measures Mixed Model|||||||0.0263
73952276|NCT01706965|147438539|SUPERIORITY|||||||0.38|||||||ANOVA|||Univariate ANOVA, controlling for baseline PANSS total||||.38
73952277|NCT01706965|147438540|SUPERIORITY|ANOVA, controlled for baseline MATRICS||||||0.99|||||||ANOVA|||||||.99
73952278|NCT00556374|147438545|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.504|||<|0.0001|TWO_SIDED|95.0|0.39|0.65|||Cox Proportional Hazards Model|Stratification factors are hospital type, prior use of aromatase inhibitor, and baseline lumbar spine BMD.|From the Cox proportional hazard model with treatment as the independent variable and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer fracture-free time for denosumab relative to placebo.|The efficacy clinical hypothesis is that denosumab, when administered subcutaneously at a dose of 60 mg every 6 months, will be considered efficacious in patients with non-metastatic breast cancer receiving AIT if the rate of first clinical fracture in denosumab-treated patients is lower than that in placebo-treated patients. It is anticipated that denosumab will reduce the rate by 30% compared with placebo (ie, the true hazard ratio of denosumab compared with placebo is 0.70).||0.65|0.39|<0.0001
73872026|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.227||95.0||||P-value for Endpoint (LOCF): HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.227
73952279|NCT00556374|147438546|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|10.02|||<|0.0001|TWO_SIDED|95.0|9.04|11.01||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||11.01|9.04|<0.0001
73952280|NCT00556374|147438547|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|7.92|||<|0.0001|TWO_SIDED|95.0|6.87|8.97||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||8.97|6.87|<0.0001
73952281|NCT00556374|147438548|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|6.51|||<|0.0001|TWO_SIDED|95.0|5.62|7.39||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||7.39|5.62|<0.0001
73979751|NCT00070707|147504713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||ANOVA|||Change at Week 3||||0.242
73979752|NCT00070707|147504713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.696|||||||ANOVA|||Change at Week 4||||0.696
73979753|NCT00070707|147504713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|||||||ANOVA|||Change at Final Week||||0.670
73979754|NCT00070707|147504714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.865|||||||ANOVA|||Baseline||||0.865
73979755|NCT00070707|147504714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|||||||ANOVA|||Change at Week 1||||0.025
73979756|NCT00070707|147504714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.288|||||||ANOVA|||Change at Week 2||||0.288
73872027|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||P-value for Endpoint (LOCF): HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.482
73872028|NCT00377858|147287353|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value for Endpoint (LOCF): HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.108
73952282|NCT00556374|147438549|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.53||||0.0088|TWO_SIDED|95.0|0.33|0.85|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values \< 1 for odds ratio favor denosumab.|||0.85|0.33|0.0088
73952283|NCT00556374|147438550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.54||||0.007|TWO_SIDED|95.0|0.34|0.84|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values \< 1 for odds ratio favor denosumab.|||0.84|0.34|0.0070
73952284|NCT00556374|147438551|SUPERIORITY||Hazard Ratio (HR)|0.816||||0.0515|TWO_SIDED|95.0|0.66|1.0|||Cox Proportional Hazards Model|Stratified by randomization strata (hospital type, use of aromatase inhibitor, baseline lumbar spine BMD).|From the Cox Proportional hazards model with treatment fitted as a covariate and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for denosumab relative to placebo.|||1.00|0.66|0.0515
73952285|NCT00556374|147438552|SUPERIORITY|Analysis of BMFS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.|Hazard Ratio (HR)|0.808|||||TWO_SIDED|95.0|0.654|0.997|||||A hazard ratio \< 1.0 indicates a lower average event rate and a longer bone metastases-free time for denosumab relative to placebo.|||0.997|0.654|
73979757|NCT00070707|147504714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||ANOVA|||Change at Week 3||||0.790
73979758|NCT00070707|147504714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.211|||||||ANOVA|||Change at Week 4||||0.211
73979759|NCT00070707|147504714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136|||||||ANOVA|||Change at Final Week||||0.136
73979760|NCT00070707|147504715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.667|||||||ANOVA|||Baseline||||0.667
73979761|NCT00070707|147504715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.656|||||||ANOVA|||Change at Week 1||||0.656
73979762|NCT00070707|147504715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458|||||||ANOVA|||Change at Week 2||||0.458
73979763|NCT00070707|147504715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||ANOVA|||Change at Week 3||||0.220
73979764|NCT00070707|147504715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775|||||||ANOVA|||Change at Week 4||||0.775
73979765|NCT00070707|147504715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994|||||||ANOVA|||Change at Final Week||||0.994
73979766|NCT00070707|147504716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.363|||||||ANOVA|||Baseline||||0.363
73979767|NCT00070707|147504716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|||||||ANOVA|||Change at Week 1||||0.262
73979768|NCT00070707|147504716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386|||||||ANOVA|||Change at Week 2||||0.386
73979769|NCT00070707|147504716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.167|||||||ANOVA|||Change at Week 3||||0.167
73979770|NCT00070707|147504716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505|||||||ANOVA|||Change at Week 4||||0.505
73979771|NCT00070707|147504716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.725|||||||ANOVA|||Change at Final Week||||0.725
73872029|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.014||95.0|0.12|1.04||P-value for Baseline: Morning Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.04|0.12|0.014
73952286|NCT00556374|147438553|SUPERIORITY|Analysis of OS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.|Hazard Ratio (HR)|0.802|||||TWO_SIDED|95.0|0.635|1.013|||||A hazard ratio \< 1.0 indicates a lower average event rate and a longer overall survival time for denosumab relative to placebo.|||1.013|0.635|
73952287|NCT02102464|147438599|SUPERIORITY||Mean Difference (Final Values)|11.0|||<|0.0001|TWO_SIDED|95.0|8.0|14.0|||t-test, 2 sided|||||14.0|8.0|<0.0001
73952288|NCT02102464|147438600|SUPERIORITY||Mean Difference (Final Values)|-7.7|||<|0.0001|TWO_SIDED|95.0|-10.2|-5.2|||t-test, 2 sided|||||-5.2|-10.2|<0.0001
73979772|NCT00070707|147504717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.954|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 15||||0.954
73979773|NCT00070707|147504717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 29||||0.295
74032957|NCT04590937|147618878|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|112.1|STANDARD_ERROR_OF_MEAN|15.4|||TWO_SIDED|90.0|101.26|124.11|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||124.11|101.26|
73952289|NCT02102464|147438601|SUPERIORITY||Mean Difference (Final Values)|3.9|||<|0.0001|TWO_SIDED|95.0|2.5|5.4|||t-test, 2 sided|||||5.4|2.5|<0.0001
73952290|NCT01053637|147438623|SUPERIORITY|||||||0.05||||||Pain at 5 minutes using Children's Hospital of Eastern Ontario Pain Scale validated in the younger population. Using a 2-point difference in CHEOPS pain scale as a clinically significant change, 34 patients were required in the younger 2- to 7 group.|Fisher Exact|||Children's Hospital of Eastern Ontario Pain Scale, for children 2-7 years. This score ranks 6 categories: Cry, Facial expression, Verbal Response, Torso movement, Touch, and Leg movement. The scale varies by each category from 0-2 or 1-2 or 1-3; such that a minimum score is 4 (no pain) and a maximum score is 13 signifying greatest or worst pain.||||0.05
73952291|NCT01053637|147438624|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||State-Trait Anxiety Inventory for Children pre vs. post procedure for matched pairs. Higher numbers indicated higher state anxiety. State Trait Anxiety Inventory for Children (STAIC) scores pre vs. post procedure for matched pairs. A lower STAIC score indicates less anxiety and a greater score indicates more anxiety based on Likert-type scales and analyzed using nonparametric testing.||||0.05
73952292|NCT00950937|147438630|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
73952293|NCT00950937|147438630|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73952294|NCT00950937|147438630|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73952295|NCT00950937|147438631|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
73952296|NCT00950937|147438631|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73952297|NCT00950937|147438631|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73952298|NCT00950937|147438632|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
73979774|NCT00070707|147504718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.268|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 15||||0.268
73979775|NCT00070707|147504718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 29||||0.154
73979776|NCT00087516|147504729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.09|<|0.001||95.0|-0.96|-0.62|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C||||-0.62|-0.96|<0.001
74032958|NCT04590937|147618879|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|161.29|STANDARD_ERROR_OF_MEAN|34.1|||TWO_SIDED|90.0|129.17|201.39|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||201.39|129.17|
73952299|NCT00950937|147438632|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73979777|NCT00087516|147504729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94|STANDARD_ERROR_OF_MEAN|0.09|<|0.001||95.0|-1.11|-0.77|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C||||-0.77|-1.11|<0.001
73979778|NCT00087516|147504730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.1|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0|-24.1|-10.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG||||-10.1|-24.1|<0.001
73979779|NCT00087516|147504730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|3.5|<|0.001||95.0|-28.2|-14.4|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG||||-14.4|-28.2|<0.001
73952300|NCT00950937|147438632|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73952301|NCT00950937|147438633|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
73952302|NCT00950937|147438633|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73952303|NCT00950937|147438633|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73952304|NCT00950937|147438634|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
73952305|NCT00950937|147438634|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73952306|NCT00950937|147438634|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73952307|NCT00950937|147438635|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
73952308|NCT00950937|147438635|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73952309|NCT00950937|147438635|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
73952310|NCT00950937|147438636|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|Paired t-test was utilized to compare the two groups (HIV group and Control group)||||||<0.05
73952311|NCT01824472|147438642|SUPERIORITY||Mean difference compared across 3 groups|0.43||||0.8|TWO_SIDED||||||Kruskal-Wallis||"Kruskal-Wallis test implemented as PROC NPAR1WAY in Statistical Analysis System (SAS v9.4) for a single groupwise comparison. The mean difference (baseline to follow-up) was determined for each group, and this was compared across all 3 groups."|||||0.8
73952312|NCT01815736|147438643|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|2.7||||0.051|TWO_SIDED|95.01|-0.3|5.6||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95.01% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|NDA Data Cut||5.6|-0.3|0.051
73952313|NCT01815736|147438643|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|4.1|||<|0.001|TWO_SIDED|95.0|1.6|6.7||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|All Participants||6.7|1.6|<0.001
74032959|NCT04590937|147618880|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|98.23|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|94.86|101.73|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||101.73|94.86|
73952314|NCT01815736|147438644|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|2.078|||<|0.001|TWO_SIDED|95.0|1.697|2.459||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut||2.459|1.697|<0.001
73952315|NCT01815736|147438644|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.807|||<|0.001|TWO_SIDED|95.0|1.488|2.126||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants||2.126|1.488|<0.001
73952316|NCT01815736|147438645|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.97|||<|0.001|TWO_SIDED|95.0|1.551|2.39||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut||2.390|1.551|<0.001
73952317|NCT01815736|147438645|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|2.0|||<|0.001|TWO_SIDED|95.0|1.549|2.452||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants||2.452|1.549|<0.001
74032960|NCT04590937|147618881|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|118.67|STANDARD_ERROR_OF_MEAN|13.0|||TWO_SIDED|90.0|108.83|129.4|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||129.40|108.83|
74032961|NCT04590937|147618882|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|114.07|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|90.0|107.93|120.56|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||120.56|107.93|
73952318|NCT01815736|147438646|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.03||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|NDA Data Cut||-0.03|-0.07|<0.001
73952319|NCT01815736|147438646|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.04|||<|0.001|TWO_SIDED|95.0|-0.05|-0.02||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|All Participants||-0.02|-0.05|<0.001
73952320|NCT01815736|147438647|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||NDA Data Cut||||<0.001
73952321|NCT01815736|147438647|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||All Participants||||<0.001
73952322|NCT01815736|147438648|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|3.7||||0.017|TWO_SIDED|95.0|0.4|7.0||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|||7.0|0.4|0.017
73872030|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.735||95.0|-0.51|0.72||P-value for Baseline: Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.72|-0.51|0.735
73872031|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.051||95.0|0.0|1.08||P-value for Baseline: Midday Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.08|-0.00|0.051
73872032|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.536||95.0|-0.39|0.75||P-value for Baseline: Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.75|-0.39|0.536
73872033|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.793||95.0|-0.48|0.62||P-value for Baseline: Evening Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.62|-0.48|0.793
73872034|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.693||95.0|-0.43|0.64||P-value for Baseline: Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.64|-0.43|0.693
73872035|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.499||95.0|-0.38|0.77||P-value for Baseline: 0300 Hours.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.77|-0.38|0.499
73872036|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|||<|0.001||95.0|0.26|0.92||P-value for 12 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.92|0.26|<0.001
73952323|NCT01815736|147438649|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|1.8||||0.29|TWO_SIDED|95.0|-1.7|5.3||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|NDA Data Cut||5.3|-1.7|0.29
74032962|NCT04590937|147618883|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|173.77|STANDARD_ERROR_OF_MEAN|30.8|||TWO_SIDED|90.0|141.9|212.8|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||212.80|141.90|
74039485|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46||0.0002|TWO_SIDED|95.0|-2.64|-0.83|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.83|-2.64|0.0002
73872037|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28||||0.278||95.0|-0.22|0.78||P-value for 12 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.78|-0.22|0.278
73872038|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.53||||0.009||95.0|0.14|0.93||P-value for 12 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.93|0.14|0.009
73872039|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.049||95.0|0.0|0.97||P-value for 12 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.97|0.00|0.049
73872040|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|||<|0.001||95.0|0.35|1.18||P-value for 12 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.18|0.35|<0.001
73872041|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.17|||<|0.001||95.0|-1.63|-0.7||P-value for 12 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.70|-1.63|<0.001
73872042|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.506||95.0|-0.59|0.29||P-value for 12 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.59|0.506
73872043|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65|||<|0.001||95.0|0.31|0.99||P-value for 24 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.99|0.31|<0.001
73872044|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.094||95.0|-0.07|0.91||P-value for 24 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.91|-0.07|0.094
73872045|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.408||95.0|-0.24|0.59||P-value for 24 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.59|-0.24|0.408
73872046|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.351||95.0|-0.25|0.71||P-value for 24 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.71|-0.25|0.351
73872047|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.01||95.0|0.13|0.98||P-value for 24 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.98|0.13|0.010
73872048|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.029||95.0|-0.92|-0.05||P-value for 24 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.05|-0.92|0.029
73872049|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.816||95.0|-0.45|0.35||P-value for 24 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.35|-0.45|0.816
73872050|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.008||95.0|0.13|0.85||P-value for 36 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.85|0.13|0.008
73872051|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.438||95.0|-0.71|0.31||P-value for 36 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.31|-0.71|0.438
73872052|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.548||95.0|-0.54|0.29||P-value for 36 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.54|0.548
73952324|NCT01815736|147438649|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|3.2||||0.031|TWO_SIDED|95.0|0.1|6.3||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|All Participants||6.3|0.1|0.031
73872053|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.964||95.0|-0.5|0.52||P-value for 36 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.52|-0.50|0.964
73872054|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.453||95.0|-0.27|0.6||P-value for 36 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.60|-0.27|0.453
73952325|NCT01815736|147438650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|5.3||||0.003|TWO_SIDED|95.0|1.6|9.0||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|||9.0|1.6|0.003
73952326|NCT01815736|147438651|SUPERIORITY||Difference in least squares means|6.0||||0.56|TWO_SIDED|95.0|-14.0|26.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. FTC/TDF+3rd Agent) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|NDA Data Cut: Change at Week 48||26|-14|0.56
73952327|NCT01815736|147438651|SUPERIORITY||Difference in least squares means|11.0||||0.26|TWO_SIDED|95.0|-8.0|29.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs.SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|All Participants: Change at Week 48||29|-8|0.26
73952328|NCT01815736|147438652|SUPERIORITY||Difference in least squares means|18.0||||0.074|TWO_SIDED|95.0|-2.0|38.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|||38|-2|0.074
73952329|NCT03317379|147438662|SUPERIORITY||estimate of fixed effects|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.8|TWO_SIDED|95.0|-0.17|0.22||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.22|-0.17|.80
73952330|NCT03317379|147438662|SUPERIORITY||estimate of fixed effects|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.32|TWO_SIDED|95.0|-0.1|0.3||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.30|-0.10|.32
73952331|NCT03317379|147438663|SUPERIORITY||estimate of fixed effects|0.14|STANDARD_ERROR_OF_MEAN|0.05||0.01|TWO_SIDED|95.0|0.03|0.24||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.24|0.03|0.01
73952332|NCT03317379|147438663|SUPERIORITY||estimate of fixed effects|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.28|TWO_SIDED|95.0|-0.07|0.23||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.23|-.07|0.28
73952333|NCT03317379|147438664|SUPERIORITY||estimate of fixed effects|0.61|STANDARD_ERROR_OF_MEAN|0.28||0.03|TWO_SIDED|95.0|0.06|1.16||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||1.16|0.06|0.03
73952334|NCT03317379|147438664|SUPERIORITY||estimate of fixed effects|0.68|STANDARD_ERROR_OF_MEAN|0.29||0.02|TWO_SIDED|95.0|0.09|1.27|||Mixed Models Analysis|||||1.27|0.09|0.02
73952335|NCT03317379|147438665|SUPERIORITY||estimate of fixed effects|0.2|STANDARD_ERROR_OF_MEAN|0.11||0.08|TWO_SIDED|95.0|-0.02|0.42||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.42|-0.02|0.08
73952336|NCT03317379|147438665|SUPERIORITY||estimate of fixed effects|0.18|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|95.0|-0.04|0.41||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.41|-0.04|0.12
73952337|NCT03317379|147438666|SUPERIORITY||estimate of fixed effects|0.03|STANDARD_ERROR_OF_MEAN|0.22||0.18|TWO_SIDED|95.0|-0.14|0.74||the a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||0.74|-0.14|0.18
73952338|NCT03317379|147438666|SUPERIORITY||estimate of fixed effects|0.16|STANDARD_ERROR_OF_MEAN|0.23||0.5|TWO_SIDED|95.0|-0.3|0.62||the a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||0.62|-0.30|0.50
73952339|NCT00550173|147438667|SUPERIORITY_OR_OTHER|||||||0.003||||||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Overall; Global null hypothesis was rejected at 2-sided 0.2 significance level.||||0.003
73979780|NCT00087516|147504731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.7|STANDARD_ERROR_OF_MEAN|6.5|<|0.001||95.0|-59.4|-34.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG||||-34.1|-59.4|<0.001
73979781|NCT00087516|147504731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.1|STANDARD_ERROR_OF_MEAN|6.4|<|0.001||95.0|-66.7|-41.6|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG||||-41.6|-66.7|<0.001
73872055|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.096||95.0|-0.84|0.07||P-value for 36 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.07|-0.84|0.096
73952340|NCT00550173|147438667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.002|TWO_SIDED|95.0|0.4|0.81||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||0.81|0.40|0.002
73979782|NCT01093690|147504735|SUPERIORITY_OR_OTHER|||||||0.41||||||No adjustment.|Chi-squared|1-sided test||the study had 80 percent power to detect an absolute difference of 20 percent in complete response (70% for metoclopramide group vs 50% for control group)||||0.41
73979783|NCT00569166|147504757|SUPERIORITY_OR_OTHER|||||||0.3679||95.0|||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.||||0.3679
73872056|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.77||95.0|-0.51|0.37||P-value for 36 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.37|-0.51|0.770
73872057|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45||||0.01||95.0|0.11|0.8||P-value for Endpoint: Morning Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.80|0.11|0.010
73872058|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.201||95.0|-0.8|0.17||P-value for Endpoint: Morning Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.17|-0.80|0.201
73872059|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.43||95.0|-0.57|0.24||P-value for Endpoint: Midday Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.24|-0.57|0.430
73872060|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.814||95.0|-0.52|0.41||P-value for Endpoint: Midday Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.41|-0.52|0.814
73979784|NCT00569166|147504757|SUPERIORITY_OR_OTHER|||||||0.4715||95.0|||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.||||0.4715
73979785|NCT00508183|147504813|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
73979786|NCT00508183|147504814|OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
73979787|NCT00508183|147504815|OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
73872061|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.427||95.0|-0.24|0.57||P-value for Endpoint: Evening Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.57|-0.24|0.427
73872062|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.009||95.0|-1.0|-0.14||P-value for Endpoint: Evening Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.14|-1.00|0.009
73979788|NCT00508183|147504817|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
73979789|NCT03547154|147504819|SUPERIORITY_OR_OTHER|||||||0.322||||||Analysis of Major Response|Fisher Exact|Missing data considered failures||||||0.322
73979790|NCT03547154|147504820|SUPERIORITY_OR_OTHER||||||>|0.999||||||Analysis of Major Response|Fisher Exact|Missing data considered failures||||||>0.999
73979791|NCT03547154|147504821|SUPERIORITY_OR_OTHER|||||||0.588||||||Analysis of Complete Response|Fisher Exact|Missing data considered failures||||||0.588
73979792|NCT03547154|147504822|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.859|||||TWO_SIDED|95.0|0.429|1.721|||||Overall survival was analyzed using the log-rank statistic. The HR and 95% CI for the HR were obtained using Cox's proportional hazards model.|||1.721|0.429|
73979793|NCT01918033|147504824|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.09||||0.661|TWO_SIDED|95.0|-0.49|0.31|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2|||0.31|-0.49|0.661
73979794|NCT01918033|147504824|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.707|TWO_SIDED|95.0|-0.48|0.32|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2|||0.32|-0.48|0.707
73979795|NCT01918033|147504827|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.48||||0.01|TWO_SIDED|95.0|-0.84|-0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3|||-0.11|-0.84|0.010
73979796|NCT01918033|147504827|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.46||||0.013|TWO_SIDED|95.0|-0.82|-0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3|||-0.10|-0.82|0.013
73952341|NCT00550173|147438667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.005|TWO_SIDED|95.0|0.39|0.85||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||0.85|0.39|0.005
73952342|NCT00550173|147438667|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.99||||0.959|TWO_SIDED|95.0|0.7|1.4||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Secondary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||1.40|0.70|0.959
73952343|NCT00550173|147438668|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||<0.001
73952344|NCT00550173|147438668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.031|TWO_SIDED|95.0|1.07|4.09|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||4.09|1.07|0.031
73952345|NCT00550173|147438668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.68|||<|0.001|TWO_SIDED|95.0|3.19|18.48|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||18.48|3.19|<0.001
73952346|NCT00550173|147438668|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.27||||0.004|TWO_SIDED|95.0|0.11|0.66|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.66|0.11|0.004
73952347|NCT00550173|147438669|SUPERIORITY_OR_OTHER|||||||0.194|||||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.194
73872063|NCT00377858|147287354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.569||95.0|-0.51|0.28||P-value for Endpoint: 0300 Hours. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.28|-0.51|0.569
73952348|NCT00550173|147438669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.747|TWO_SIDED|95.0|0.69|1.67|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.67|0.69|0.747
73952349|NCT00550173|147438669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.168|TWO_SIDED|95.0|0.49|1.13|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.13|0.49|0.168
73952350|NCT00550173|147438669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.094|TWO_SIDED|95.0|0.94|2.21|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.21|0.94|0.094
73952351|NCT00550173|147438671|SUPERIORITY_OR_OTHER|||||||0.306|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.306
73952352|NCT00550173|147438671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.127|TWO_SIDED|95.0|0.87|3.18|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||3.18|0.87|0.127
74039486|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.42||0.5412|TWO_SIDED|95.0|-1.09|0.57|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.57|-1.09|0.5412
73952353|NCT00550173|147438671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.318|TWO_SIDED|95.0|0.72|2.71|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.71|0.72|0.318
73952354|NCT00550173|147438671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.599|TWO_SIDED|95.0|0.63|2.22|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.22|0.63|0.599
73952355|NCT00550173|147438672|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.013
73952356|NCT00550173|147438672|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.007|TWO_SIDED|95.0|0.41|0.87||Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.87|0.41|0.007
73952357|NCT00550173|147438672|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.62|1.38|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.38|0.62|0.700
73952358|NCT00550173|147438672|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.023|TWO_SIDED|95.0|0.44|0.94|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.94|0.44|0.023
73952359|NCT00550173|147438673|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Cox|||||||0.040
73952360|NCT00550173|147438673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.241|TWO_SIDED|95.0|0.27|1.38|||Regression, Cox|||||1.38|0.27|0.241
73872064|NCT00377858|147287355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.776||95.0|-0.14|0.19||P-value for Baseline MODD.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.19|-0.14|0.776
73872065|NCT00377858|147287355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.27||||0.737||95.0|-6.14|8.68||P-value for Baseline M-Value.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||8.68|-6.14|0.737
73872066|NCT00377858|147287355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.701||95.0|-0.19|0.13||P-value for 12 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.13|-0.19|0.701
73952361|NCT00550173|147438673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32||||0.011|TWO_SIDED|95.0|0.14|0.78|||Regression, Cox|||||0.78|0.14|0.011
73952362|NCT00550173|147438673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.128|TWO_SIDED|95.0|0.83|4.36|||Regression, Cox|||||4.36|0.83|0.128
73952363|NCT02325713|147438686|SUPERIORITY_OR_OTHER||Geometric Least square (LS) mean ratio|96.2|||||TWO_SIDED|90.0|83.7|110.6||||||||110.6|83.7|
73952364|NCT02325713|147438686|SUPERIORITY_OR_OTHER||Geometric LS mean ration|18.4|||||TWO_SIDED|90.0|15.3|22.0||||||||22.0|15.3|
73952365|NCT02325713|147438686|SUPERIORITY_OR_OTHER||Geometric LS mean ration|222.7|||||TWO_SIDED|90.0|186.8|265.6||||||||265.6|186.8|
73952366|NCT02325713|147438686|SUPERIORITY_OR_OTHER||Geometric LS mean ration|238.1|||||TWO_SIDED|90.0|198.7|285.3||||||||285.3|198.7|
73952367|NCT02325713|147438686|SUPERIORITY_OR_OTHER||Geometric LS mean ration|82.1|||||TWO_SIDED|90.0|68.5|98.3||||||||98.3|68.5|
73979797|NCT01918033|147504827|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.12||||0.569|TWO_SIDED|95.0|-0.29|0.53|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1|||0.53|-0.29|0.569
73979798|NCT01918033|147504827|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.09||||0.685|TWO_SIDED|95.0|-0.33|0.5|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1|||0.50|-0.33|0.685
74089416|NCT02697773|147731625|SUPERIORITY||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.56|-0.64|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.64|-1.56|<.0001
73952368|NCT03824535|147438714|SUPERIORITY|||||||0.02||||||The threshold for statistical significance was set at p \< 0.05|Wilcoxon (Mann-Whitney)|||Analysis applies to the row 'Specificity' in the Outcome Measure data table.||||0.02
73979799|NCT01918033|147504828|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.547|TWO_SIDED|95.0|-0.15|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2|||0.08|-0.15|0.547
73979800|NCT01918033|147504828|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.1||||0.067|TWO_SIDED|95.0|-0.22|0.01|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2|||0.01|-0.22|0.067
73872067|NCT00377858|147287355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.58||||0.4||95.0|-2.11|5.27||P-value for 12 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||5.27|-2.11|0.400
73952369|NCT03824535|147438715|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was predefined as p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.004
73952370|NCT03824535|147438715|SUPERIORITY|||||||0.05||||||The threshold for statistical significance was predefined as p ≤ 0.05.|Wilcoxon (Mann-Whitney)|||||||0.05
73952371|NCT03824535|147438715|SUPERIORITY|||||||0.06||||||The threshold for statistical significance was predefined as p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.06
73952372|NCT02096081|147438769|NON_INFERIORITY_OR_EQUIVALENCE|"The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group. The hypothesis testing procedure to test the equivalence of the two products is as follows:~Ho (null): D ≤ -∆ OR D ≥ ∆ versus Ha (alternate): -∆ \< D \< ∆, where ∆ is the margin of equivalence = 0.15."|Difference in proportions of response|-3.5|||||TWO_SIDED|95.0|-7.5|0.6|||||If the confidence interval lies within the limits of ±0.15, then Ho is rejected in favor of Ha (i.e., equivalence of incobotulinumtoxinA and onabotulinumtoxinA can be concluded); otherwise, treatment equivalence cannot be concluded.|With assumptions of an alpha of 5%, an equivalence margin of 15% for each side, the real response rate expected as 90% for incobotulinumtoxinA and onabotulinumtoxinA at day 30 and a 1:1 allocation ratio, a total of 225 subjects were needed to achieve a statistical power of 90% in order to make an equivalence conclusion at day 30. Results are based on the Newcombe-Wilson confidence interval. To account for exclusions from the PPS of about 10%, approximately 250 subjects were enrolled.||0.6|-7.5|
73952373|NCT02096081|147438770|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.3|||||TWO_SIDED|95.0|-12.1|1.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||1.5|-12.1|
73952374|NCT02096081|147438771|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-0.5|||||TWO_SIDED|95.0|-10.6|9.6|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||9.6|-10.6|
73952375|NCT02096081|147438772|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.2|||||TWO_SIDED|95.0|-17.4|7.1|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||7.1|-17.4|
73952376|NCT02096081|147438773|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.7|||||TWO_SIDED|95.0|-8.5|3.2|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||3.2|-8.5|
73952377|NCT02096081|147438774|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.8|||||TWO_SIDED|95.0|-11.0|5.3|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||5.3|-11.0|
73952378|NCT02096081|147438775|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.5|||||TWO_SIDED|95.0|-12.4|9.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||9.5|-12.4|
73979801|NCT01918033|147504828|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.895|TWO_SIDED|95.0|-0.15|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2|||0.13|-0.15|0.895
73979802|NCT01918033|147504828|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.03||||0.627|TWO_SIDED|95.0|-0.1|0.17|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2|||0.17|-0.10|0.627
73979803|NCT01918033|147504828|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.04||||0.535|TWO_SIDED|95.0|-0.09|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2|||0.18|-0.09|0.535
73979804|NCT01918033|147504828|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.04||||0.557|TWO_SIDED|95.0|-0.1|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2|||0.18|-0.10|0.557
73979805|NCT01918033|147504828|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.11||||0.119|TWO_SIDED|95.0|-0.25|0.03|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2|||0.03|-0.25|0.119
73979806|NCT01918033|147504828|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.403|TWO_SIDED|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2|||0.08|-0.20|0.403
73979807|NCT01918033|147504829|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.376|TWO_SIDED|95.0|-0.2|0.07|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2|||0.07|-0.20|0.376
73979808|NCT01918033|147504829|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.714|TWO_SIDED|95.0|-0.16|0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2|||0.11|-0.16|0.714
73979809|NCT01918033|147504829|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.725|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2|||0.13|-0.19|0.725
73979810|NCT01918033|147504829|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.708|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2|||0.13|-0.19|0.708
73952379|NCT02096081|147438776|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.9|||||TWO_SIDED|95.0|-14.4|10.7|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||10.7|-14.4|
73979811|NCT01918033|147504829|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.03||||0.68|TWO_SIDED|95.0|-0.1|0.16|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2|||0.16|-0.10|0.680
73979812|NCT01918033|147504829|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.06||||0.373|TWO_SIDED|95.0|-0.07|0.19|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2|||0.19|-0.07|0.373
73979813|NCT01918033|147504830|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.849|TWO_SIDED|95.0|-0.14|0.12|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2|||0.12|-0.14|0.849
73979814|NCT01918033|147504830|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.07||||0.26|TWO_SIDED|95.0|-0.2|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2|||0.06|-0.20|0.260
73979815|NCT01918033|147504831|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.826||||0.34|TWO_SIDED|95.0|0.558|1.223|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \>1 is in favor of the first group of the pairwise comparison.|||1.223|0.558|0.340
73979816|NCT01918033|147504831|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.755||||0.159|TWO_SIDED|95.0|0.51|1.116|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \>1 is in favor of the first group of the pairwise comparison.|||1.116|0.510|0.159
73952380|NCT00688259|147438833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||||||.30
73952381|NCT00688259|147438834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|||||||Mixed Models Analysis|||||||.09
73952382|NCT00688259|147438835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46|||||||Mixed Models Analysis|||||||.46
73952383|NCT00688259|147438836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|||||||Mixed Models Analysis|||||||.55
73952384|NCT00688259|147438837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||||||.50
73952385|NCT00688259|147438838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||Mixed Models Analysis|||||||.25
73952386|NCT04227340|147438875|OTHER|The count, percentage and confidence interval will be calculated for allogeneic HCT patients who receive PBM and develop Grade 3 mucositis|Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.091|0.356|||||Odds of grade 3 in Allogeneic group compared to historical rates. The study efficacy of mucositis reduction by 20% with an estimation of 51% developing grade 3 mucositis.|The count, percentage and confidence interval were calculated for allogeneic HCT participants who receive PBM and developed Grade 3 mucositis. Whether the percentage of the prospective sample is significantly different from the estimated rate of 71% was accessed.||0.356|0.091|
73979817|NCT01918033|147504832|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.705|TWO_SIDED|95.0|-0.09|0.14|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2|||0.14|-0.09|0.705
73979818|NCT01918033|147504832|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.02||||0.782|TWO_SIDED|95.0|-0.13|0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2|||0.10|-0.13|0.782
73952387|NCT04227340|147438876|SUPERIORITY|||||||0.03|||||||Wilcox Rank Sum|||||||0.03
73952388|NCT04227340|147438878|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
73952389|NCT04227340|147438880|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73952390|NCT04227340|147438882|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.1
73952391|NCT04227340|147438884|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
73952392|NCT03088137|147438935|EQUIVALENCE|Study power of at least 80% at a significance level (alpha error) 5% and a pre-determined clinical equivalence margin of +/- 3.4 oocytes for the relevant population.|Mean Difference (Final Values)|0.546|STANDARD_DEVIATION|1.297||0.002|TWO_SIDED|95.0|-2.026|3.116|||Wilcoxon (Mann-Whitney)|||||3.116|-2.026|0.002
73952393|NCT03088137|147438936|SUPERIORITY||Mean Difference (Final Values)|0.709|STANDARD_DEVIATION|1.067||0.806|TWO_SIDED|95.0|-1.405|2.824|||Wilcoxon (Mann-Whitney)|||||2.824|-1.405|0.806
73952394|NCT03088137|147438937|SUPERIORITY||Mean Difference (Final Values)|0.218|STANDARD_DEVIATION|1.129||0.617|TWO_SIDED|95.0|-2.455|2.019|||Wilcoxon (Mann-Whitney)|||||2.019|-2.455|0.617
73952395|NCT03088137|147438938|SUPERIORITY||Mean Difference (Final Values)|0.636|STANDARD_DEVIATION|1.19||0.445|TWO_SIDED|95.0|-2.995|1.723|||Wilcoxon (Mann-Whitney)|||||1.723|-2.995|0.445
73952396|NCT03088137|147438939|SUPERIORITY|||||||0.623|||||||ANOVA|||||||0.623
73952397|NCT03088137|147438940|SUPERIORITY||Mean Difference (Final Values)|14.9|STANDARD_DEVIATION|49.8||0.488|TWO_SIDED|95.0|-83.9|113.6|||Wilcoxon (Mann-Whitney)|||||113.6|-83.9|0.488
73872068|NCT00377858|147287355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.321||95.0|-0.26|0.09||P-value for 24 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.09|-0.26|0.321
73872069|NCT00377858|147287355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.52||||0.179||95.0|-1.16|6.21||P-value for 24 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||6.21|-1.16|0.179
73872070|NCT00377858|147287355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.573||95.0|-0.22|0.12||P-value for 36 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.12|-0.22|0.573
73979819|NCT01918033|147504833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.1||||0.175|TWO_SIDED|95.0|-0.24|0.04|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2|||0.04|-0.24|0.175
73979820|NCT01918033|147504833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.12||||0.098|TWO_SIDED|95.0|-0.26|0.02|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2|||0.02|-0.26|0.098
73872071|NCT00377858|147287355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95||||0.629||95.0|-4.79|2.9||P-value for 36 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||2.90|-4.79|0.629
73979821|NCT01918033|147504833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.12||||0.13|TWO_SIDED|95.0|-0.04|0.27|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2|||0.27|-0.04|0.130
73979822|NCT01918033|147504833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.07||||0.375|TWO_SIDED|95.0|-0.08|0.22|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2|||0.22|-0.08|0.375
73872072|NCT00377858|147287355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.25||95.0|-0.26|0.07||P-value for Endpoint MODD. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.07|-0.26|0.250
73872073|NCT00377858|147287355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.72||||0.362||95.0|-5.44|1.99||P-value for Endpoint M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.99|-5.44|0.362
73952398|NCT03088137|147438941|SUPERIORITY||Mean Difference (Final Values)|0.018|STANDARD_DEVIATION|0.201||0.629|TWO_SIDED|95.0|-0.379|0.416|||Wilcoxon (Mann-Whitney)|||||0.416|-0.379|0.629
73952399|NCT03088137|147438942|SUPERIORITY|||||||0.644|||||||Wilcoxon (Mann-Whitney)|||||||0.644
73979823|NCT01918033|147504833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.08||||0.285|TWO_SIDED|95.0|-0.07|0.24|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2|||0.24|-0.07|0.285
73979824|NCT01918033|147504833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.05||||0.49|TWO_SIDED|95.0|-0.1|0.21|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2|||0.21|-0.10|0.490
73979825|NCT01918033|147504833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.345|TWO_SIDED|95.0|-0.23|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2|||0.08|-0.23|0.345
73979826|NCT01918033|147504833|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.699|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2|||0.13|-0.19|0.699
73979827|NCT01918033|147504834|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.414|TWO_SIDED|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2|||0.08|-0.20|0.414
73872074|NCT00377858|147287356|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||P-value for Endpoint Hypoglycemic Episodes.|Fisher Exact|||||||0.094
73952400|NCT03088137|147438945|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.833|TWO_SIDED|95.0|-21.0|17.0|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.||17.0|-21.0|0.833
73952401|NCT03088137|147438946|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.507|TWO_SIDED|95.0|-24.3|11.9|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.||11.9|-24.3|0.507
73952402|NCT00918749|147438954|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.598|STANDARD_ERROR_OF_MEAN|4.215||0.3946|TWO_SIDED|90.0|-10.568|3.372|||ANOVA|Fixed effects for treatment and center.||A two group t-test with a 0.100 one-sided significance level would have 96% power to detect the difference between a risedronate 150 mg IRBB mean, µ1, of -46.000 and a risedronate 75 mg DRFB mean, µ2, of -29.900 (a difference in means of -16.100), assuming that the common SD was 28.000, with sample sizes of 60 per group, respectively. Estimates were based on Study 2005107 (35 mg DR once a week Phase 2 study). The sample size calculation was not adjusted for multiplicity.||3.372|-10.568|0.3946
73952403|NCT00918749|147438954|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.197|STANDARD_ERROR_OF_MEAN|4.241||0.0045|TWO_SIDED|90.0|-19.208|-5.185|||ANOVA|Fixed effects for treatment and center.||||-5.185|-19.208|0.0045
73952404|NCT00918749|147438955|SUPERIORITY_OR_OTHER||LS Mean Difference|4.765|STANDARD_ERROR_OF_MEAN|4.952||0.3372|TWO_SIDED|90.0|-3.421|12.952|||ANOVA|Fixed effects for treatment and center.||||12.952|-3.421|0.3372
73952405|NCT00918749|147438955|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.218|STANDARD_ERROR_OF_MEAN|4.966||0.965|TWO_SIDED|90.0|-8.427|7.991|||ANOVA|Fixed effects for treatment and center.||||7.991|-8.427|0.9650
73952406|NCT00918749|147438956|SUPERIORITY_OR_OTHER||LS Mean Difference|0.388|STANDARD_ERROR_OF_MEAN|4.269||0.9276|TWO_SIDED|90.0|-6.67|7.447|||ANOVA|Fixed effects for treatment and center.||||7.447|-6.670|0.9276
73952407|NCT00918749|147438956|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.787|STANDARD_ERROR_OF_MEAN|4.313||0.0133|TWO_SIDED|90.0|-17.917|-3.657|||ANOVA|Fixed effects for treatment and center.||||-3.657|-17.917|0.0133
73952408|NCT00918749|147438957|SUPERIORITY_OR_OTHER||LS Mean Difference|14.528|STANDARD_ERROR_OF_MEAN|9.28||0.1192|TWO_SIDED|90.0|-0.813|29.868|||ANOVA|Fixed effects for treatment and center.||||29.868|-0.813|0.1192
73952409|NCT00918749|147438957|SUPERIORITY_OR_OTHER||LS Mean Difference|14.215|STANDARD_ERROR_OF_MEAN|9.343||0.1298|TWO_SIDED|90.0|-1.23|29.659|||ANOVA|Fixed effects for treatment and center.||||29.659|-1.230|0.1298
73872075|NCT00377858|147287356|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Overall Hypoglycemic Episodes.|Fisher Exact|||||||1.00
73952410|NCT00918749|147438958|SUPERIORITY_OR_OTHER||LS Mean Difference|1.119|STANDARD_ERROR_OF_MEAN|6.093||0.8546|TWO_SIDED|90.0|-8.956|11.193|||ANOVA|Fixed effects for treatment and center.||||11.193|-8.956|0.8546
73952411|NCT00918749|147438958|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.393|STANDARD_ERROR_OF_MEAN|6.126||0.2291|TWO_SIDED|90.0|-17.522|2.737|||ANOVA|Fixed effects for treatment and center.||||2.737|-17.522|0.2291
73979828|NCT01918033|147504834|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.281|TWO_SIDED|95.0|-0.22|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2|||0.06|-0.22|0.281
73979829|NCT04679675|147504835|SUPERIORITY||Risk Ratio (RR)|1.3||||0.05|TWO_SIDED|95.0|1.23|1.36|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Direct-Mail versus Education analysis.||1.36|1.23|0.05
73952412|NCT00918749|147438959|SUPERIORITY_OR_OTHER||LS Mean Difference|5.505|STANDARD_ERROR_OF_MEAN|9.046||0.5436|TWO_SIDED|90.0|-9.452|20.462|||ANOVA|Fixed effects for treatment and center.||||20.462|-9.452|0.5436
73952413|NCT00918749|147438959|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.914|STANDARD_ERROR_OF_MEAN|9.1||0.9201|TWO_SIDED|90.0|-15.959|14.132|||ANOVA|Fixed effects for treatment and center.||||14.132|-15.959|0.9201
73952414|NCT00918749|147438960|SUPERIORITY_OR_OTHER||LS Mean Difference|3.108|STANDARD_ERROR_OF_MEAN|4.052||0.444|TWO_SIDED|90.0|-3.59|9.807|||ANOVA|Fixed effects for treatment and center.||||9.807|-3.590|0.4440
73952415|NCT00918749|147438960|SUPERIORITY_OR_OTHER||LS Mean Difference|4.842|STANDARD_ERROR_OF_MEAN|4.063||0.2349|TWO_SIDED|90.0|-1.874|11.559|||ANOVA|Fixed effects for treatment and center.||||11.559|-1.874|0.2349
73952416|NCT00918749|147438961|SUPERIORITY_OR_OTHER||LS Mean Difference|4.966|STANDARD_ERROR_OF_MEAN|4.327||0.2527|TWO_SIDED|90.0|-2.189|12.12|||ANOVA|Fixed effects for treatment and center.||||12.120|-2.189|0.2527
73952417|NCT00918749|147438961|SUPERIORITY_OR_OTHER||LS Mean Difference|4.926|STANDARD_ERROR_OF_MEAN|4.371||0.2613|TWO_SIDED|90.0|-2.301|12.153|||ANOVA|Fixed effects for treatment and center.||||12.153|-2.301|0.2613
73979830|NCT04679675|147504835|SUPERIORITY||Risk Ratio (RR)|1.07||||0.05|TWO_SIDED|95.0|1.02|1.12|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Opt-In versus Education analysis.||1.12|1.02|.05
73872076|NCT00377858|147287356|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.430
73952418|NCT00918749|147438962|SUPERIORITY_OR_OTHER||LS Mean Difference|1.269|STANDARD_ERROR_OF_MEAN|4.16||0.7606|TWO_SIDED|90.0|-5.609|8.148|||ANOVA|Fixed effects for treatment and center.||||8.148|-5.609|0.7606
73952419|NCT00918749|147438962|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.825|STANDARD_ERROR_OF_MEAN|4.185||0.5006|TWO_SIDED|90.0|-9.744|4.095|||ANOVA|Fixed effects for treatment and center.||||4.095|-9.744|0.5006
73952420|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.011||||90.0|-0.064|-0.026|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M3||-0.026|-0.064|
73952421|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.025|0.02|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6||0.020|-0.025|
73952422|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.033|0.013|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M9||0.013|-0.033|
73952423|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.044|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12||0.004|-0.044|
73952424|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.048|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M15||0.003|-0.048|
73979831|NCT04679675|147504835|SUPERIORITY||Risk Ratio (RR)|1.9||||0.05|TWO_SIDED|95.0|1.68|2.16|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Overdue (population):Direct-Mail versus Education analysis.||2.16|1.68|.05
73872077|NCT00377858|147287356|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Overall Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||1.00
73952425|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.016||||90.0|-0.05|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M18||0.004|-0.050|
73952426|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.047|0.007|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M21||0.007|-0.047|
73952427|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.054|0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24||0.002|-0.054|
73952428|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.021|0.034|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1||0.034|-0.021|
73952429|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.018||||90.0|-0.016|0.044|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3||0.044|-0.016|
73952430|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.002|0.055|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6||0.055|-0.002|
73952431|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.04|0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1||0.032|-0.040|
73952432|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.07|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3||0.004|-0.070|
73952433|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.077|-0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6||-0.002|-0.077|
73952434|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.075|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M9||0.003|-0.075|
73952435|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.058|0.022|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12||0.022|-0.058|
73952436|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.034|0.048|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M15||0.048|-0.034|
73979832|NCT04679675|147504835|SUPERIORITY||Risk Ratio (RR)|1.14||||0.05|TWO_SIDED|95.0|1.03|1.25|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Unknown (population):Opt-In versus Education analysis.||1.25|1.03|.05
73979833|NCT01762982|147504859|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0654||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0654
73872078|NCT00377858|147287356|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.013
73952437|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.055|0.033|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18||0.033|-0.055|
73952438|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.058|0.029|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M21||0.029|-0.058|
73952439|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.061|0.03|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24||0.030|-0.061|
73952440|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.044|0.043|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M27||0.043|-0.044|
73952441|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.051|0.04|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30||0.040|-0.051|
73952442|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.03||||90.0|-0.042|0.058|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M33||0.058|-0.042|
73952443|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.032||||90.0|-0.03|0.077|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36||0.077|-0.030|
73952444|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.042|0.035|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF||0.035|-0.042|
73952445|NCT00136916|147438986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.023|0.062|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3||0.062|-0.023|
73952446|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.058||||90.0|-0.215|-0.023|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M3||-0.023|-0.215|
73952447|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.067||||90.0|-0.133|0.087|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M6||0.087|-0.133|
73952448|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.069||||90.0|-0.104|0.124|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M9||0.124|-0.104|
73952449|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.075||||90.0|-0.033|0.214|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M12||0.214|-0.033|
73872079|NCT00377858|147287356|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.756
73952450|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.081||||90.0|-0.081|0.185|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M15||0.185|-0.081|
73872080|NCT00377858|147287357|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Endpoint Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.022
73872081|NCT00377858|147287357|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for Overall Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.218
73872082|NCT00377858|147287357|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.311
73952451|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.087||||90.0|-0.054|0.234|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M18||0.234|-0.054|
73952452|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.085||||90.0|-0.073|0.208|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M21||0.208|-0.073|
73952453|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.096||||90.0|-0.058|0.257|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M24||0.257|-0.058|
73952454|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.09||||90.0|-0.143|0.154|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M3||0.154|-0.143|
73952455|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.094||||90.0|-0.119|0.19|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M6||0.190|-0.119|
73952456|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.2|0.161|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M1||0.161|-0.200|
73952457|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.101|0.263|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M3||0.263|-0.101|
73979834|NCT01762982|147504862|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0078||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0078
73979835|NCT01762982|147504863|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0547||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0547
73872083|NCT00377858|147287357|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||P-value for Overall Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.615
73872084|NCT00377858|147287357|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.018
73872085|NCT00377858|147287357|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.255
73872086|NCT00377858|147287358|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for Overall Severe Hypoglycemic Episodes.|Fisher Exact|||||||0.416
73952458|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.108||||90.0|-0.038|0.32|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M6||0.320|-0.038|
73952459|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.116||||90.0|-0.041|0.342|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M9||0.342|-0.041|
73952460|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.118||||90.0|-0.09|0.298|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M12||0.298|-0.090|
73952461|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|STANDARD_ERROR_OF_MEAN|0.125||||90.0|-0.132|0.279|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M15||0.279|-0.132|
73952462|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.12||||90.0|-0.111|0.284|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M18||0.284|-0.111|
73952463|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.141|0.27|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M21||0.270|-0.141|
73952464|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.123||||90.0|-0.156|0.249|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M24||0.249|-0.156|
73952465|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.138|0.272|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M27||0.272|-0.138|
73952466|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.132||||90.0|-0.171|0.264|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M30||0.264|-0.171|
73952467|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.824|STANDARD_ERROR_OF_MEAN|8.319||||90.0|-3.92|23.569|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M33||23.569|-3.920|
73952468|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.197||||90.0|-0.316|0.337|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M36||0.337|-0.316|
73952469|NCT00136916|147438992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.163||||90.0|-0.245|0.292|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext FU M3||0.292|-0.245|
73952470|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.39|STANDARD_ERROR_OF_MEAN|4.054||||90.0|-19.07|-5.71|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M3||-5.710|-19.07|
73952471|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.21|STANDARD_ERROR_OF_MEAN|4.795||||90.0|-22.11|-6.312|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M6||-6.312|-22.11|
73952472|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.96|STANDARD_ERROR_OF_MEAN|4.92||||90.0|-19.07|-2.852|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M12||-2.852|-19.07|
73952473|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.56|STANDARD_ERROR_OF_MEAN|5.052||||90.0|-20.89|-4.232|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M24||-4.232|-20.89|
73952474|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.83|STANDARD_ERROR_OF_MEAN|21.867||||90.0|-80.69|47.019|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M3||47.019|-80.69|
73952475|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.578|STANDARD_ERROR_OF_MEAN|7.173||||90.0|-9.257|14.412|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M6||14.412|-9.257|
73952476|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.46|STANDARD_ERROR_OF_MEAN|6.007||||90.0|-19.37|0.45|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M1||0.450|-19.37|
73952477|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.481|STANDARD_ERROR_OF_MEAN|6.446||||90.0|-20.11|1.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M3||1.153|-20.11|
73952478|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.76|STANDARD_ERROR_OF_MEAN|6.785||||90.0|-21.95|0.438|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M6||0.438|-21.95|
73952479|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.827|STANDARD_ERROR_OF_MEAN|6.154||||90.0|-16.98|3.328|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M9||3.328|-16.98|
73872087|NCT00377858|147287359|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|||<|0.001||95.0|-0.12|-0.05||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.05|-0.12|<0.001
73952480|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.287|STANDARD_ERROR_OF_MEAN|7.192||||90.0|-19.15|4.579|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M12||4.579|-19.15|
73979836|NCT01029704|147504871|SUPERIORITY||Difference of LS Means|-16.923||||0.0989|TWO_SIDED|95.0|-37.076|3.23||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||3.230|-37.076|0.0989
73952481|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.848|STANDARD_ERROR_OF_MEAN|7.219||||90.0|-13.76|10.066|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M15||10.066|-13.76|
73952482|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.022|STANDARD_ERROR_OF_MEAN|7.156||||90.0|-20.83|2.79|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M18||2.790|-20.83|
73952483|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.078|STANDARD_ERROR_OF_MEAN|7.217||||90.0|-18.99|4.834|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M21||4.834|-18.99|
73952484|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.53|STANDARD_ERROR_OF_MEAN|7.329||||90.0|-24.63|-0.429|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M24||-0.429|-24.63|
73952485|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.07|STANDARD_ERROR_OF_MEAN|6.895||||90.0|-30.45|-7.685|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M27||-7.685|-30.45|
73952486|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.22|STANDARD_ERROR_OF_MEAN|7.223||||90.0|-15.15|8.705|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M30||8.705|-15.15|
73952487|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49|STANDARD_ERROR_OF_MEAN|7.625||||90.0|-21.09|4.107|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M33||4.107|-21.09|
73952488|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.88|STANDARD_ERROR_OF_MEAN|8.906||||90.0|-36.66|-7.105|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M36||-7.105|-36.66|
73952489|NCT00136916|147438993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.673|STANDARD_ERROR_OF_MEAN|8.77||||90.0|-19.16|9.812|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext FU M3||9.812|-19.16|
73952490|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059|STANDARD_ERROR_OF_MEAN|0.217||||90.0|-0.416|0.299|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M3||0.299|-0.416|
73952491|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.735|STANDARD_ERROR_OF_MEAN|0.297||||90.0|-1.224|-0.246|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M6||-0.246|-1.224|
73952492|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.642|STANDARD_ERROR_OF_MEAN|0.37||||90.0|-1.251|-0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M12||-0.032|-1.251|
73952493|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.355|STANDARD_ERROR_OF_MEAN|0.464||||90.0|-2.12|-0.589|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M24||-0.589|-2.120|
73952494|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.303|STANDARD_ERROR_OF_MEAN|0.475||||90.0|-2.086|-0.52|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M3||-0.520|-2.086|
73872088|NCT00377858|147287359|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||<|0.001||95.0|0.04|0.11||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.11|0.04|<0.001
73979837|NCT01029704|147504871|SUPERIORITY||Difference of LS Means|-17.834||||0.0964|TWO_SIDED|95.0|-38.909|3.242||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||3.242|-38.909|0.0964
73979838|NCT01029704|147504871|SUPERIORITY||Difference of LS Means|-19.991||||0.0465|TWO_SIDED|95.0|-39.67|-0.312||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.312|-39.670|0.0465
73952495|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.557|STANDARD_ERROR_OF_MEAN|0.596||||90.0|-2.539|-0.575|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M6||-0.575|-2.539|
73979839|NCT01029704|147504871|SUPERIORITY||Difference of LS Means|-32.01||||0.0015|TWO_SIDED|95.0|-51.487|-12.533||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-12.533|-51.487|0.0015
73979840|NCT01029704|147504873|SUPERIORITY||Difference of LS Means|-1.434||||0.0025|TWO_SIDED|95.0|-2.349|-0.52||P-values are from a two-sided test.|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.520|-2.349|0.0025
73979841|NCT01029704|147504873|SUPERIORITY||Difference of LS Means|-1.037||||0.0269|TWO_SIDED|95.0|-1.952|-0.122||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.122|-1.952|0.0269
73952496|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.904|STANDARD_ERROR_OF_MEAN|0.603||||90.0|-1.898|0.09|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M1||0.090|-1.898|
73952497|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.573||||90.0|-2.225|-0.334|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M3||-0.334|-2.225|
73979842|NCT01029704|147504873|SUPERIORITY||Difference of LS Means|-2.054|||<|0.0001|TWO_SIDED|95.0|-2.938|-1.17||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-1.170|-2.938|< 0.0001
73979843|NCT01029704|147504873|SUPERIORITY||Difference of LS Means|-1.172||||0.009|TWO_SIDED|95.0|-2.044|-0.301||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.301|-2.044|0.0090
73979844|NCT01029704|147504874|SUPERIORITY||Difference of LS Means|-0.353||||0.0281|TWO_SIDED|95.0|-0.668|-0.039||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.039|-0.668|0.0281
73979845|NCT01029704|147504874|SUPERIORITY||Difference of LS Means|-0.155||||0.3215|TWO_SIDED|95.0|-0.464|0.154||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||0.154|-0.464|0.3215
74089417|NCT02697773|147731625|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.24||0.0091|TWO_SIDED|95.0|-1.11|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-1.11|0.0091
73979846|NCT01029704|147504874|SUPERIORITY||Difference of LS Means|-0.004||||0.9776|TWO_SIDED|95.0|-0.304|0.295||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||0.295|-0.304|0.9776
73979847|NCT01029704|147504874|SUPERIORITY||Difference of LS Means|-0.344||||0.0242|TWO_SIDED|95.0|-0.642|-0.046||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.046|-0.642|0.0242
73979848|NCT01029704|147504876|SUPERIORITY||Difference of LS Means|17.688||||0.1613|TWO_SIDED|95.0|-7.21|42.587||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||42.587|-7.210|0.1613
73979849|NCT01029704|147504876|SUPERIORITY||Difference of LS Means|17.091||||0.2079|TWO_SIDED|95.0|-9.696|43.877||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||43.877|-9.696|0.2079
73979850|NCT01029704|147504876|SUPERIORITY||Difference of LS Means|24.379||||0.041|TWO_SIDED|95.0|1.028|47.731||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||47.731|1.028|0.0410
73952498|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.834|STANDARD_ERROR_OF_MEAN|0.652||||90.0|-1.909|0.241|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M6||0.241|-1.909|
73952499|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.001|STANDARD_ERROR_OF_MEAN|0.654||||90.0|-2.08|0.078|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M9||0.078|-2.080|
73952500|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.316|STANDARD_ERROR_OF_MEAN|0.676||||90.0|-2.431|-0.2|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M12||-0.200|-2.431|
73952501|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.512|STANDARD_ERROR_OF_MEAN|0.696||||90.0|-2.661|-0.363|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M15||-0.363|-2.661|
73872089|NCT00377858|147287359|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.017||95.0|0.01|0.12||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.12|0.01|0.017
73872090|NCT00377858|147287360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.96|||<|0.001||95.0|-9.65|-4.26||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-4.26|-9.65|<0.001
73872091|NCT00377858|147287360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.05|||<|0.001||95.0|3.39|8.71||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||8.71|3.39|<0.001
73872092|NCT00377858|147287360|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.2||||0.017||95.0|0.93|9.46||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||9.46|0.93|0.017
73872093|NCT00377858|147287361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|||<|0.001||95.0|0.24|0.42||P-value for Week 12.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.42|0.24|<0.001
73872094|NCT00377858|147287361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.003||95.0|0.07|0.36||P-value for Week 24.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.36|0.07|0.003
73872095|NCT00377858|147287361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.002||95.0|0.09|0.4||P-value for Week 30.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.40|0.09|0.002
73872096|NCT00377858|147287361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.005||95.0|0.07|0.38||P-value for Week 36.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.38|0.07|0.005
73872097|NCT00377858|147287361|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.011||95.0|0.04|0.34||P-value for Endpoint. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.34|0.04|0.011
73872098|NCT00377858|147287362|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.803||95.0|-0.8|0.62||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Sulfonylurea stratum + Country + Baseline HbA1c stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.62|-0.80|0.803
73952502|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.313|STANDARD_ERROR_OF_MEAN|0.916||||90.0|-2.824|0.198|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M18||0.198|-2.824|
73952503|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.399|STANDARD_ERROR_OF_MEAN|0.904||||90.0|-3.891|-0.907|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M21||-0.907|-3.891|
73952504|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.566|STANDARD_ERROR_OF_MEAN|0.788||||90.0|-2.867|-0.265|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M24||-0.265|-2.867|
73952505|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|1.041||||90.0|-4.439|-1.001|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M27||-1.001|-4.439|
73952506|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.401|STANDARD_ERROR_OF_MEAN|0.82||||90.0|-2.755|-0.047|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M30||-0.047|-2.755|
73952507|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.281|STANDARD_ERROR_OF_MEAN|0.908||||90.0|-3.781|-0.782|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M33||-0.782|-3.781|
73952508|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.766|STANDARD_ERROR_OF_MEAN|1.305||||90.0|-4.932|-0.599|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M36||-0.599|-4.932|
73952509|NCT00136916|147438994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.637|STANDARD_ERROR_OF_MEAN|0.898||||90.0|-3.12|-0.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext FU M3||-0.153|-3.120|
73979851|NCT01029704|147504876|SUPERIORITY||Difference of LS Means|20.749||||0.0862|TWO_SIDED|95.0|-3.019|44.518||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||44.518|-3.019|0.0862
73979852|NCT01235936|147504904|OTHER|The primary endpoint was compared using the Wilcoxon signed-rank test, with an alpha level of 0.05.||||||0.002|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||0.0020
73979853|NCT01235936|147504905|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0156|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0156
73979854|NCT01235936|147504906|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.||||||0.0098|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||0.0098
73979855|NCT01235936|147504907|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0195|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0195
73979856|NCT01235936|147504908|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.8262|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.8262
73979857|NCT01235936|147504914|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.002|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0020
73979858|NCT01235936|147504915|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.2383|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.2383
73979859|NCT01235936|147504916|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0039|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0039
73979860|NCT01235936|147504917|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0039|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0039
73979861|NCT00068107|147504968|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||eGFR measured pre-study was compared to eGFR during the study||||0.01
73979862|NCT00068107|147504968|SUPERIORITY_OR_OTHER||Average Delay in time to ESRD|166.0|||||TWO_SIDED|95.0|8.4|323.8|||||The average delay in end stage renal disease (ESRD) calculated from the eGFR values and represents the estimated difference in time to ESRD between Relagal administered every 2 weeks and Relagal administered weekly. Units = months|||323.8|8.4|
73979863|NCT03205488|147504974|SUPERIORITY|||||||0.3626|||||||Fisher Exact|One-sided Fisher's Exact tested the proportion of participants who met tolerability between the Nilotinib 150 group to the Placebo group.||||||0.3626
73979864|NCT03205488|147504974|SUPERIORITY|||||||0.3895|||||||Fisher Exact|One-sided Fisher's Exact tested the proportion of participants who met tolerability between the Nilotinib 300 group to the Placebo group.||||||0.3895
73979865|NCT03205488|147504975|EQUIVALENCE|H0 : p1 = p2, where p represents the proportion of SAEs for each group. HA : p1 ≠ p2||||||1|||||||Fisher Exact|Fisher's Exact test compared a proportion of participants who experienced any serious adverse event in the Nilotinib 150 group and the Placebo group.||||||1.00
73979866|NCT03205488|147504975|EQUIVALENCE|H0 : λ1 = λ2, where λ represents the rate of SAEs for each group. HA : λ1 ≠ λ2|Risk Ratio (RR)|0.4977||||0.5689|TWO_SIDED|95.0|0.0451|5.489|||Regression, Poisson|Rates of serious adverse event between the Nilotinib 150 group and the placebo were also compared using a Poisson regression model||||5.489|0.0451|0.5689
73979867|NCT03205488|147504975|EQUIVALENCE|H0 : p1 = p3, where p represents the proportion of SAEs for each group. HA : p1 ≠ p3||||||0.61|||||||Fisher Exact|Fisher's Exact test compared a proportion of participants who experienced any serious adverse event in the Nilotinib 300 group and the Placebo group.||||||0.61
73979868|NCT03205488|147504975|EQUIVALENCE|H0 : λ1 = λ3, where λ represents the rate of SAEs for each group. HA : λ1 ≠ λ3|Risk Ratio (RR)|0.5206||||0.594|TWO_SIDED|95.0|0.0472|5.7409|||Regression, Poisson|Rates of serious adverse event between the Nilotinib 300 group and the placebo were also compared using a Poisson regression model||||5.7409|0.0472|0.5940
73979869|NCT03205488|147504976|NON_INFERIORITY|The hypotheses of interest (H0: δ ≤ -9.8 (7 x 1.4) vs. HA: δ \> -9.8) where δ represents the change from baseline to 6 months using the MDS-UPDRS Part III ON in the Nilotinib 150 mg treatment group. The hypotheses of interest were evaluated based on an assessment of parameter estimates from a non-linear mixed effects model, adjusted for a participant's Levodopa Equivalent Daily Dose (LEDD) at each time point.|Slope|1.05||||0.0001|ONE_SIDED|90.0|-0.78||||Mixed Models Analysis|||The key secondary objective is to conduct a futility analysis within each treatment group which examines the observed change in the MDS-UPDRS Part III ON within the two dose groups compared to previously reported changes from the Pagan et al (2016) study (NCT02281474).|||-0.78|0.0001
74032963|NCT01544595|147618884|SUPERIORITY|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.42|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,"||0.42|0.22|<0.0001
73979870|NCT03205488|147504976|NON_INFERIORITY|The hypotheses of interest (H0: δ ≤ -9.8 (7 x 1.4) vs. HA: δ \> -9.8) where δ represents the change from baseline to 6 months using the MDS-UPDRS Part III ON in the Nilotinib 300 mg treatment group. The hypotheses of interest were evaluated based on an assessment of parameter estimates from a non-linear mixed effects model, adjusted for a participant's Levodopa Equivalent Daily Dose (LEDD) at each time point.|Slope|0.93||||0.0001|ONE_SIDED|90.0|-0.89||||Mixed Models Analysis|||The key secondary objective is to conduct a futility analysis within each treatment group which examines the observed change in the MDS-UPDRS Part III ON within the two dose groups compared to previously reported changes from the Pagan et al (2016) study (NCT02281474).|||-0.89|0.0001
73979871|NCT03205488|147504976|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using the same LMM as in the key secondary analysis, a two degree of freedom test was used to test for any differences in the slopes from baseline to 1 month for the three treatment groups.||||||0.031|||||||Mixed Models Analysis|||Additional secondary objective #1 is to establish the degree of symptomatic effect of Nilotinib as measured by the change in the MDS\_UPDRS Part III ON score between baseline and 1 month.|In order to assess which group may be driving these findings, pairwise comparisons were also utilized (Nilotinib 150 vs PBO at 1 Month, Nilotinib 300 vs PBO at 1 month, Nilotinib 300 vs Nilotinib 150 at 1 month).|||0.031
73979872|NCT03205488|147504976|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. For this analysis, a separate LMM was constructed, modeling the change from final visit on study drug to the 30 and 60 day follow up visits, while adjusting for the MDS-UPDRS Part III ON scores at the final visit on study drug as well as the Levodopa Equivalent Daily Dose (LEDD) at each visit.||||||0.47|||||||Mixed Models Analysis|||Additional secondary objective #2 is to establish the degree of symptomatic effect of Nilotinib as measured by the change in the MDS\_UPDRS Part III ON score between the final visit on study drug and 30 days off study drug.||||0.47
73872099|NCT04034004|147287366|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Pain ratings were collected while lying in the supine and after each straight leg rasise test (SLR 1; SLR 2). A 2 (group) X 2 (SLR 1-rest vs. SLR 2-meditation) X 2 (supine vs. SLR) X 3 (session) repeated measure mixed model ANOVA was conducted to determine if mindfulness and non-mindfulness meditation attenuate SLR induced pain through endogenous opioids. Simple effects tests tested significant main effects and interactions to test primary study hypotheses and between-group differences.||||.05
73872100|NCT00666406|147287373|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.173|||||TWO_SIDED|90.0|1.089|1.262||||||||1.262|1.089|
73872101|NCT00666406|147287374|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.139|||||TWO_SIDED|90.0|1.043|1.243||||||||1.243|1.043|
73872102|NCT00666406|147287375|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.06|||||TWO_SIDED|90.0|0.866|1.297||||||||1.297|0.866|
73872103|NCT00666406|147287376|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.071|||||TWO_SIDED|90.0|0.972|1.179||||||||1.179|0.972|
73872104|NCT00666406|147287377|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.171|||||TWO_SIDED|90.0|1.099|1.247||||||||1.247|1.099|
73872105|NCT00666406|147287378|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.135|||||TWO_SIDED|90.0|1.092|1.18||||||||1.180|1.092|
73872106|NCT00666406|147287379|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.036|||||TWO_SIDED|90.0|0.857|1.253||||||||1.253|0.857|
73872107|NCT00666406|147287380|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.093|||||TWO_SIDED|90.0|1.007|1.186||||||||1.186|1.007|
73872108|NCT00666406|147287381|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.854|||||TWO_SIDED|90.0|0.798|0.913||||||||0.913|0.798|
73872109|NCT00666406|147287382|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.881|||||TWO_SIDED|90.0|0.847|0.916||||||||0.916|0.847|
73872110|NCT00666406|147287383|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.964|||||TWO_SIDED|90.0|0.799|1.164||||||||1.164|0.799|
73872111|NCT00666406|147287384|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.915|||||TWO_SIDED|90.0|0.841|0.995||||||||0.995|0.841|
73872112|NCT00666406|147287385|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.177|||||TWO_SIDED|90.0|1.104|1.256||||||||1.256|1.104|
73872113|NCT00666406|147287386|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.152|||||TWO_SIDED|90.0|1.039|1.277||||||||1.277|1.039|
73872114|NCT00666406|147287387|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.182|||||TWO_SIDED|90.0|1.029|1.359||||||||1.359|1.029|
73952510|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.13||||90.0|-0.466|-0.037|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M3||-0.037|-0.466|
73872115|NCT00666406|147287388|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.133|||||TWO_SIDED|90.0|1.01|1.27||||||||1.270|1.010|
73872116|NCT00666406|147287389|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.008|||||TWO_SIDED|90.0|0.969|1.05||||||||1.050|0.969|
73872117|NCT00666406|147287390|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.964|||||TWO_SIDED|90.0|0.843|1.102||||||||1.102|0.843|
73872118|NCT00666406|147287391|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.038|||||TWO_SIDED|90.0|0.926|1.163||||||||1.163|0.926|
73872119|NCT00666406|147287392|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.015|||||TWO_SIDED|90.0|0.901|1.144||||||||1.144|0.901|
73872120|NCT00666406|147287393|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.178|||||TWO_SIDED|90.0|1.106|1.254||||||||1.254|1.106|
73872121|NCT00666406|147287394|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.152|||||TWO_SIDED|90.0|1.038|1.279||||||||1.279|1.038|
73872122|NCT00666406|147287395|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.183|||||TWO_SIDED|90.0|1.027|1.362||||||||1.362|1.027|
73872123|NCT00666406|147287396|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.133|||||TWO_SIDED|90.0|1.012|1.27||||||||1.270|1.012|
73872124|NCT00666406|147287397|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.009|||||TWO_SIDED|90.0|0.964|1.056||||||||1.056|0.964|
73872125|NCT00666406|147287398|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.971|||||TWO_SIDED|90.0|0.849|1.112||||||||1.112|0.849|
73872126|NCT00666406|147287399|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.02|||||TWO_SIDED|90.0|0.938|1.109||||||||1.109|0.938|
73872127|NCT00666406|147287400|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.996|||||TWO_SIDED|90.0|0.894|1.111||||||||1.111|0.894|
73872128|NCT00666406|147287401|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.0|||||TWO_SIDED|90.0|1.0|1.0||||||||1.000|1.000|
73872129|NCT00666406|147287402|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.303|||||TWO_SIDED|90.0|0.841|2.02||||||||2.020|0.841|
73872130|NCT00666406|147287403|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.724|||||TWO_SIDED|90.0|0.304|1.728||||||||1.728|0.304|
73872131|NCT00666406|147287404|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.059|||||TWO_SIDED|90.0|0.442|2.539||||||||2.539|0.442|
73872132|NCT00666406|147287405|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.862|||||TWO_SIDED|90.0|0.807|0.92||||||||0.920|0.807|
73872133|NCT00666406|147287406|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.855|||||TWO_SIDED|90.0|0.73|1.002||||||||1.002|0.730|
73872134|NCT00666406|147287407|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.984|||||TWO_SIDED|90.0|0.788|1.228||||||||1.228|0.788|
73872135|NCT00666406|147287408|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.911|||||TWO_SIDED|90.0|0.8|1.039||||||||1.039|0.800|
73872136|NCT06964165|147287420|OTHER||Difference in pre-IDS ORR|-39.0|||||TWO_SIDED|80.0|-56.8|-17.7|||||||Confidence interval was calculated using the unstratified Miettinen-Nurminen method.|-17.7|-56.8|
73952511|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.095|STANDARD_ERROR_OF_MEAN|0.139||||90.0|-0.323|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6||0.134|-0.323|
73952512|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.146||||90.0|-0.158|0.325|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M9||0.325|-0.158|
73952513|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.156||||90.0|-0.524|-0.009|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12||-0.009|-0.524|
73952514|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.181|STANDARD_ERROR_OF_MEAN|0.165||||90.0|-0.453|0.091|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M15||0.091|-0.453|
73952515|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.173||||90.0|-0.427|0.145|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M18||0.145|-0.427|
73952516|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.155|STANDARD_ERROR_OF_MEAN|0.176||||90.0|-0.445|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M21||0.134|-0.445|
73952517|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.189||||90.0|-0.193|0.431|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24||0.431|-0.193|
73952518|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.617|STANDARD_ERROR_OF_MEAN|0.179||||90.0|0.322|0.911|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1||0.911|0.322|
73952519|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354|STANDARD_ERROR_OF_MEAN|0.184||||90.0|0.051|0.657|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3||0.657|0.051|
73952520|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.186||||90.0|0.011|0.626|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6||0.626|0.011|
73952521|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.22||||90.0|-0.227|0.5|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1||0.500|-0.227|
73952522|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.235||||90.0|-0.289|0.485|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3||0.485|-0.289|
73979873|NCT03205488|147504976|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using the same LMM as in the key secondary analysis, a two degree of freedom test was used to test for any differences in the slopes from baseline to 6 months for the three treatment groups.||||||0.077|||||||Mixed Models Analysis|||Additional secondary objective #3 is to assess the impact of Nilotinib on the progression of PD disability as measured by the change in the MDS\_UPDRS Part III ON score between baseline and 6 months.|Pairwise comparisons were also examined for trends (Active 150 vs PBO at 6 Months, Active 300 vs PBO at 6 months).|||0.077
73979874|NCT03205488|147504976|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using a similar LMM as in the key secondary analysis, except simplified to only include baseline, month 3 and month 6, a two degree of freedom test was used to test for any differences in the slopes from baseline to 6 months for the three treatment groups.||||||0.17|||||||Mixed Models Analysis|||Additional secondary objective #3 is to assess the impact of Nilotinib on the progression of PD disability as measured by the change in the MDS\_UPDRS Part III OFF score between baseline and 6 months.||||0.17
73979875|NCT03652610|147504983|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratio for serogroup A is \> 0.5|GMT ratio|0.88|||||TWO_SIDED|95.0|0.64|1.2|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) to that of currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted human serum bactericidal assay (hSBA) Geometric Mean Titers (GMTs) directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination||1.20|0.64|
74039487|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.42||0.0107|TWO_SIDED|95.0|-1.87|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-1.87|0.0107
73952523|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.226||||90.0|-0.576|0.172|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6||0.172|-0.576|
73952524|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.257||||90.0|-0.18|0.669|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M9||0.669|-0.180|
73952525|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.248||||90.0|-0.284|0.535|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12||0.535|-0.284|
73952526|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.253||||90.0|-0.395|0.441|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M15||0.441|-0.395|
73952527|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.247||||90.0|-0.262|0.554|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18||0.554|-0.262|
73952528|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.321|STANDARD_ERROR_OF_MEAN|0.278||||90.0|-0.138|0.78|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M21||0.780|-0.138|
73952529|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-0.419|0.506|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24||0.506|-0.419|
73952530|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.284||||90.0|-0.279|0.659|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M27||0.659|-0.279|
73952531|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-0.579|0.346|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30||0.346|-0.579|
73952532|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.273||||90.0|-0.189|0.714|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M33||0.714|-0.189|
73952533|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.267|STANDARD_ERROR_OF_MEAN|0.383||||90.0|-0.37|0.904|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36||0.904|-0.370|
73952534|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.399|STANDARD_ERROR_OF_MEAN|0.244||||90.0|-0.003|0.802|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF||0.802|-0.003|
73952535|NCT00136916|147439000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.619|STANDARD_ERROR_OF_MEAN|0.292||||90.0|0.137|1.102|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3||1.102|0.137|
73952536|NCT01152554|147439013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.24||0.697|TWO_SIDED|95.0|0.54|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.50|0.54|0.697
73952537|NCT01152554|147439014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|STANDARD_ERROR_OF_MEAN|0.27||0.582|TWO_SIDED|95.0|0.45|1.57|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.57|0.45|0.582
73952538|NCT00577720|147439041|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.437|||||TWO_SIDED|90.0|1.091|1.964||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.964|1.091|
73952539|NCT00577720|147439041|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.507|||||TWO_SIDED|90.0|1.139|2.066||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||2.066|1.139|
73979876|NCT03652610|147504984|OTHER||GMT ratio|1.19|||||TWO_SIDED|95.0|0.84|1.68|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup C at Day 29||1.68|0.84|
73979877|NCT03652610|147504984|OTHER||GMT ratio|1.23|||||TWO_SIDED|95.0|0.96|1.58|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup W at Day 29||1.58|0.96|
73952540|NCT00577720|147439041|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.535|||||TWO_SIDED|90.0|1.177|2.086||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||2.086|1.177|
73952541|NCT00577720|147439041|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.068|||||TWO_SIDED|90.0|0.867|1.321||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.321|0.867|
73952542|NCT00577720|147439041|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.018|||||TWO_SIDED|90.0|0.824|1.267||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.267|0.824|
73952543|NCT00577720|147439042|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.208|||||TWO_SIDED|90.0|0.749|2.099||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.099|0.749|
73952544|NCT00577720|147439042|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.132|||||TWO_SIDED|90.0|0.665|2.003||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.003|0.665|
73952545|NCT00577720|147439042|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.407|||||TWO_SIDED|90.0|0.913|2.404||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.404|0.913|
73952546|NCT00577720|147439042|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.165|||||TWO_SIDED|90.0|0.797|1.752||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.752|0.797|
73952547|NCT00577720|147439042|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.243|||||TWO_SIDED|90.0|0.828|1.99||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.990|0.828|
73952548|NCT00577720|147439043|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|0.947|||||TWO_SIDED|90.0|0.316|2.993||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.993|0.316|
73952549|NCT00577720|147439043|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.82|||||TWO_SIDED|90.0|0.929|5.429||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||5.429|0.929|
73952550|NCT00577720|147439043|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.58|||||TWO_SIDED|90.0|0.801|4.718||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||4.718|0.801|
73952551|NCT00577720|147439043|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.668|||||TWO_SIDED|90.0|0.856|4.668||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||4.668|0.856|
73952552|NCT00577720|147439043|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mgDRBB)|0.868|||||TWO_SIDED|90.0|0.504|1.488||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.488|0.504|
73979878|NCT03652610|147504984|OTHER||GMT ratio|1.19|||||TWO_SIDED|95.0|0.9|1.58|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup Y at Day 29||1.58|0.90|
73952553|NCT02806336|147439060|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||change in combined groups||||0.03
73952554|NCT02806336|147439061|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
73952555|NCT02806336|147439062|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
73979879|NCT03652610|147504986|OTHER||Difference in percentage of subjects|-3.87|||||TWO_SIDED|95.0|-9.3|1.52|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||1.52|-9.30|
73979880|NCT03652610|147504986|OTHER||Difference in percentage of subjects|1.87|||||TWO_SIDED|95.0|-4.7|8.43|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||8.43|-4.70|
73979881|NCT03652610|147504986|OTHER||Difference in percentage of subjects|4.54|||||TWO_SIDED|95.0|-1.97|11.01|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||11.01|-1.97|
73952556|NCT02806336|147439063|SUPERIORITY|||||||0.03||||||change in functional gait analysis (FGA) in combined groups compared to baseline|t-test, 2 sided|||||||0.03
73952557|NCT02806336|147439064|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
73952558|NCT02806336|147439065|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||.17
73952559|NCT02806336|147439065|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
73952560|NCT02806336|147439066|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
73952561|NCT01563978|147439081|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|2.93||||0.023|TWO_SIDED|95.0|0.4|5.45|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||||5.45|0.40|0.023
73952562|NCT01563978|147439082|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|3.53|||<|0.001|TWO_SIDED|95.0|2.04|5.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||||5.03|2.04|<0.001
73952563|NCT01563978|147439083|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.3||||0.02|TWO_SIDED|95.0|0.53|6.08|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean daytime SBP (Day 28)||6.08|0.53|0.020
73952564|NCT01563978|147439083|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.75|||<|0.001|TWO_SIDED|95.0|2.08|5.42|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean daytime DBP (Day 28)||5.42|2.08|<0.001
73952565|NCT01563978|147439083|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.07||||0.179|TWO_SIDED|95.0|-0.96|5.11|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean night-time SBP (Day 28)||5.11|-0.96|0.179
73952566|NCT01563978|147439083|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.14||||0.002|TWO_SIDED|95.0|1.13|5.14|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean night-time DBP (Day 28)||5.14|1.13|0.002
73979882|NCT03652610|147504986|OTHER||Difference in percentage of subjects|5.25|||||TWO_SIDED|95.0|-1.11|11.57|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||11.57|-1.11|
73979883|NCT03652610|147504987|OTHER||Difference in percentage of subjects|-2.47|||||TWO_SIDED|95.0|-6.47|1.49|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 1||1.49|-6.47|
73979884|NCT03652610|147504987|OTHER||Difference in percentage of subjects|-0.58|||||TWO_SIDED|95.0|-6.99|5.83|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 1||5.83|-6.99|
73979885|NCT03652610|147504987|OTHER||Difference in percentage of subjects|-5.95|||||TWO_SIDED|95.0|-12.33|0.47|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 1||0.47|-12.33|
73979886|NCT03652610|147504987|OTHER||Difference in percentage of subjects|-2.78|||||TWO_SIDED|95.0|-8.3|2.76|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 1||2.76|-8.30|
73979887|NCT03652610|147504987|OTHER||Difference in percentage of subjects|-3.69|||||TWO_SIDED|95.0|-8.65|1.21|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 29||1.21|-8.65|
73952567|NCT01563978|147439084|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.11||||0.024|TWO_SIDED|95.0|0.41|5.81|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean awake SBP (Day 28)||5.81|0.41|0.024
73952568|NCT01563978|147439084|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.66|||<|0.001|TWO_SIDED|95.0|2.1|5.22|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean awake DBP (Day 28)||5.22|2.10|<0.001
73979888|NCT03652610|147504987|OTHER||Difference in percentage of subjects|-0.4|||||TWO_SIDED|95.0|-6.12|5.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 29||5.33|-6.12|
73979889|NCT03652610|147504987|OTHER||Difference in percentage of subjects|0.26|||||TWO_SIDED|95.0|-5.49|6.02|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 29||6.02|-5.49|
73979890|NCT03652610|147504987|OTHER||Difference in percentage of subjects|1.15|||||TWO_SIDED|95.0|-4.33|6.62|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 29||6.62|-4.33|
73979891|NCT03652610|147504988|OTHER||Difference in percentage of subjects|-2.91|||||TWO_SIDED|95.0|-7.24|1.37|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||1.37|-7.24|
73979892|NCT03652610|147504988|OTHER||Difference in percentage of subjects|-1.09|||||TWO_SIDED|95.0|-7.34|5.16|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||5.16|-7.34|
73952569|NCT01563978|147439085|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|1.99||||0.223|TWO_SIDED|95.0|-1.22|5.2|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean sleeping SBP||5.20|-1.22|0.223
73979893|NCT03652610|147504988|OTHER||Difference in percentage of subjects|-5.95|||||TWO_SIDED|95.0|-12.35|0.5|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||0.50|-12.35|
74032964|NCT01544595|147618884|SUPERIORITY|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.14|0.29|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,"||0.29|0.14|<0.0001
73979894|NCT03652610|147504988|OTHER||Difference in percentage of subjects|-2.55|||||TWO_SIDED|95.0|-8.15|3.06|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||3.06|-8.15|
73979895|NCT03652610|147504988|OTHER||Difference in percentage of subjects|-3.92|||||TWO_SIDED|95.0|-8.87|0.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||0.96|-8.87|
73979896|NCT03652610|147504988|OTHER||Difference in percentage of subjects|0.07|||||TWO_SIDED|95.0|-5.52|5.65|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||5.65|-5.52|
73979897|NCT03652610|147504988|OTHER||Difference in percentage of subjects|-0.17|||||TWO_SIDED|95.0|-5.92|5.57|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||5.57|-5.92|
73979898|NCT03652610|147504988|OTHER||Difference in percentage of subjects|0.5|||||TWO_SIDED|95.0|-4.89|5.9|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||5.90|-4.89|
73979899|NCT02203032|147505049|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
73952570|NCT01563978|147439085|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.87||||0.007|TWO_SIDED|95.0|0.81|4.93|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean sleeping DBP||4.93|0.81|0.007
73979900|NCT02203032|147505050|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
73979901|NCT02203032|147505051|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
73979902|NCT02203032|147505052|SUPERIORITY_OR_OTHER||||||=|0.001|||||||Cochran-Mantel-Haenszel|||||||= 0.001
73952571|NCT01563978|147439086|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.24||||0.2|TWO_SIDED|95.0|-1.2|5.69|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in clinic SBP (Day 29)||5.69|-1.20|0.200
73952572|NCT01563978|147439086|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.36||||0.046|TWO_SIDED|95.0|0.05|4.68|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in clinic DBP (Day 29)||4.68|0.05|0.046
73952573|NCT01563978|147439087|SUPERIORITY_OR_OTHER||Least square means treatment difference|6.31|||<|0.001|TWO_SIDED|95.0|3.6|9.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home SBP (Week 4)||9.03|3.60|<0.001
73952574|NCT01563978|147439087|SUPERIORITY_OR_OTHER||Least square means treatment difference|4.58|||<|0.001|TWO_SIDED|95.0|2.91|6.25|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home DBP (Week 4)||6.25|2.91|<0.001
73952575|NCT01563978|147439088|SUPERIORITY_OR_OTHER||Least square means treatment difference|7.22|||<|0.001|TWO_SIDED|95.0|4.29|10.16|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home SBP (Week 4)||10.16|4.29|<0.001
73952576|NCT01563978|147439088|SUPERIORITY_OR_OTHER||Least square means treatment difference|4.74|||<|0.001|TWO_SIDED|95.0|2.9|6.59|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home DBP (Week 4)||6.59|2.90|<0.001
73979903|NCT01915914|147505053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|13.4993|||<|0.0001|TWO_SIDED|95.0|4.1113|44.325|||Log Rank|||||44.3250|4.1113|<0.0001
73979904|NCT01915914|147505054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.9524|||<|0.0001|TWO_SIDED|95.0|2.4258|10.1105|||Log Rank|||||10.1105|2.4258|<0.0001
73979905|NCT01915914|147505055|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73979906|NCT01915914|147505056|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
73979907|NCT01915914|147505058|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74089418|NCT02697773|147731625|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.24||0.0668|TWO_SIDED|95.0|-0.92|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.92|0.0668
74089419|NCT02697773|147731625|SUPERIORITY||Least Square Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.26||0.0011|TWO_SIDED|95.0|-1.36|-0.34|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.34|-1.36|0.0011
74089420|NCT02697773|147731625|SUPERIORITY||Least Square Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.26||0.0002|TWO_SIDED|95.0|-1.48|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.48|0.0002
74089421|NCT02697773|147731625|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25||0.0059|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-1.20|0.0059
73952577|NCT01563978|147439090|SUPERIORITY_OR_OTHER||Least square means treatment difference|0.74|||<|0.001|TWO_SIDED|95.0|0.4|1.08||Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)|ANCOVA|||Improvement from baseline at Day 29. Non-responder imputation has been applied following premature withdrawal, or any dose of background disease modifying antirheumatic drug increased or any other RA treatment initiated including DMARDs, anti-TNFs or other biologics, or receiving any parenteral steroids, or for patients with no post baseline data.||1.08|0.40|<0.001
73952578|NCT03077620|147439153|SUPERIORITY||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.064||0.05|TWO_SIDED|95.0|-0.017|0.256||Poor sleepers compared to good sleepers with Compound Symmetry covariance structure. Mean difference is poor sleepers minus good sleepers.|Mixed Models Analysis|||||0.256|-0.017|0.05
73952579|NCT03077620|147439154|SUPERIORITY||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.033||0.05|TWO_SIDED|95.0|-0.078|0.087||After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.|Mixed Models Analysis|||||0.087|-0.078|0.05
73979908|NCT01915914|147505059|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
73979909|NCT01915914|147505064|SUPERIORITY_OR_OTHER|||||||0.701||95.0||||Week 20, CA|Wilcoxon (Mann-Whitney)|||||||0.7010
73979910|NCT01915914|147505064|SUPERIORITY_OR_OTHER|||||||0.0042||95.0||||Week 20, ET/L|Wilcoxon (Mann-Whitney)|||||||0.0042
73979911|NCT01915914|147505064|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||Week 20, AP|Wilcoxon (Mann-Whitney)|||||||0.0810
73979912|NCT01915914|147505064|SUPERIORITY_OR_OTHER|||||||0.2799||95.0||||Week 32, CA|Wilcoxon (Mann-Whitney)|||||||0.2799
73952580|NCT03077620|147439154|SUPERIORITY||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.033||0.05|TWO_SIDED|95.0|-0.051|0.117||After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.|Mixed Models Analysis|||||0.117|-0.051|0.05
73952581|NCT02036515|147439208|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.69|||<|0.001|TWO_SIDED|95.0|-0.87|-0.5|||Constrained longitudinal data analysis|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.50|-0.87|<0.001
73952582|NCT02036515|147439208|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.76|||<|0.001|TWO_SIDED|95.0|-0.95|-0.58|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.58|-0.95|<0.001
73952583|NCT02036515|147439209|SUPERIORITY_OR_OTHER||Difference in percentage|-5.7|||||TWO_SIDED|95.0|-16.5|5.2||||||||5.2|-16.5|
73952584|NCT02036515|147439209|SUPERIORITY_OR_OTHER||Difference in percentage|-3.3|||||TWO_SIDED|95.0|-14.1|7.6||||||||7.6|-14.1|
73952585|NCT02036515|147439210|SUPERIORITY_OR_OTHER||Difference in percentage|0.6|||||TWO_SIDED|95.0|-4.4|5.6||||||||5.6|-4.4|
73979913|NCT01915914|147505064|SUPERIORITY_OR_OTHER|||||||0.1375||95.0||||Week 32, ET/L|Wilcoxon (Mann-Whitney)|||||||0.1375
73979914|NCT01915914|147505064|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||Week 32, AP|Wilcoxon (Mann-Whitney)|||||||0.1100
73979915|NCT01915914|147505064|SUPERIORITY_OR_OTHER|||||||0.0394||95.0||||Week 20, Total VAS Score|Wilcoxon (Mann-Whitney)|||||||0.0394
73979916|NCT01915914|147505064|SUPERIORITY_OR_OTHER|||||||0.2237||95.0||||Week 32, Total VAS Score|Wilcoxon (Mann-Whitney)|||||||0.2237
73979917|NCT01528605|147505065|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference||||<0.05
73979918|NCT01528605|147505066|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference||||<0.05
73979919|NCT01528605|147505067|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||"The null hypothesis is no group difference"||||>0.05
74032965|NCT04525222|147618906|OTHER||Slope|0.42||||0.0088|TWO_SIDED|95.0|0.1|0.74|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||"Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from not at all to very much. We used a linear regression adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), and Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5) to test for differences between arms."||0.74|0.10|0.0088
73979920|NCT02432274|147505091|OTHER||||||=|0.20359|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)||||=0.20359
73979921|NCT02432274|147505091|OTHER||||||=|0.50068|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)||||=0.50068
73952586|NCT02036515|147439210|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.9|4.9||||||||4.9|-4.9|
73979922|NCT02432274|147505091|OTHER||||||=|0.05512|||||||Wilcoxon Rank-Sum Test|||C3D1: FGF 19 (PFS-4, Yes) vs. C3D1: FGF 19 (PFS-4, No)||||=0.05512
73979923|NCT02432274|147505091|OTHER||||||=|0.50382|||||||Wilcoxon Rank-Sum Test|||C4D1: FGF 19 (PFS-4, Yes) vs. C4D1: FGF 19 (PFS-4, No)||||=0.50382
73952587|NCT02036515|147439211|SUPERIORITY_OR_OTHER||Differenc in least squares means|-25.15|||<|0.001|TWO_SIDED|95.0|-32.76|-17.54|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-17.54|-32.76|<0.001
73952588|NCT02036515|147439211|SUPERIORITY_OR_OTHER||Difference in least squares means|-31.28|||<|0.001|TWO_SIDED|95.0|-38.9|-23.66|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-23.66|-38.90|<0.001
73952589|NCT02036515|147439212|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.03|||<|0.001|TWO_SIDED|95.0|-2.65|-1.4|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.40|-2.65|<0.001
73952590|NCT02036515|147439212|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.72|||<|0.001|TWO_SIDED|95.0|-2.35|-1.09|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.09|-2.35|<0.001
73952591|NCT02036515|147439213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.74|5.72|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.||||5.72|1.74|<0.001
73952592|NCT02036515|147439213|SUPERIORITY_OR_OTHER||Difference in least squares means|4.43|||<|0.001|TWO_SIDED|95.0|2.44|8.02|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.||||8.02|2.44|<0.001
73952593|NCT02036515|147439214|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.93||||0.019|TWO_SIDED|95.0|-5.36|-0.49|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.49|-5.36|0.019
73979924|NCT02432274|147505091|OTHER||||||=|0.0476|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 21 (PFS-4, Yes) vs. C2D1: FGF 21 (PFS-4, No)||||=0.04760
73979925|NCT02432274|147505091|OTHER||||||=|0.2142|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 21 (PFS-4, Yes) vs. C2D1: FGF 21 (PFS-4, No)||||=0.21420
73979926|NCT02432274|147505091|OTHER||||||=|0.42542|||||||Wilcoxon Rank-Sum Test|||C3D1: FGF 21 (PFS-4, Yes) vs. C3D1: FGF 21 (PFS-4, No)||||=0.42542
73979927|NCT02432274|147505091|OTHER||||||=|0.73573|||||||Wilcoxon Rank-Sum Test|||C4D1: FGF 21 (PFS-4, Yes) vs. C4D1: FGF 21 (PFS-4, No)||||=0.73573
73979928|NCT02432274|147505091|OTHER||||||=|0.35754|||||||Wilcoxon Rank-Sum Test|||C2D1: VEGF (PFS-4, Yes) vs. C2D1: VEGF (PFS-4, No)||||=0.35754
73979929|NCT02432274|147505091|OTHER||||||=|0.59903|||||||Wilcoxon Rank-Sum Test|||C2D1: VEGF (PFS-4, Yes) vs. C2D1: VEGF (PFS-4, No)||||=0.59903
73979930|NCT02432274|147505091|OTHER||||||=|1|||||||Wilcoxon Rank-Sum Test|||C3D1: VEGF (PFS-4, Yes) vs. C3D1: VEGF (PFS-4, No)||||=1.00000
73979931|NCT02725372|147505115|SUPERIORITY||Mean Difference (Final Values)|1.99||||0.87|TWO_SIDED|95.0|-22.47|26.45|||Mixed Models Analysis|||||26.45|-22.47|0.87
73979932|NCT02725372|147505116|SUPERIORITY|||||||0.55|||||||Log Rank|||||||0.55
73952594|NCT02036515|147439214|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.94||||0.002|TWO_SIDED|95.0|-6.39|-1.5|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.50|-6.39|0.002
73952595|NCT02036515|147439215|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76|||||TWO_SIDED|95.0|-0.98|-0.54||||||||-0.54|-0.98|
73952596|NCT02036515|147439215|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.83|||||TWO_SIDED|95.0|-1.05|-0.61||||||||-0.61|-1.05|
73952597|NCT02036515|147439216|SUPERIORITY_OR_OTHER||Difference in least squares means|-28.76|||||TWO_SIDED|95.0|-36.44|-21.09||||||||-21.09|-36.44|
73952598|NCT02036515|147439216|SUPERIORITY_OR_OTHER||Difference in least squares means|-29.58|||||TWO_SIDED|95.0|-37.3|-21.85||||||||-21.85|-37.30|
73952599|NCT02036515|147439217|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.51|||||TWO_SIDED|95.0|-3.43|-1.59||||||||-1.59|-3.43|
73952600|NCT02036515|147439217|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.88|||||TWO_SIDED|95.0|-2.81|-0.95||||||||-0.95|-2.81|
73952601|NCT02036515|147439218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||||TWO_SIDED|95.0|1.98|6.64||||||||6.64|1.98|
73952602|NCT02036515|147439218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.02|||||TWO_SIDED|95.0|2.22|7.28||||||||7.28|2.22|
73952603|NCT02036515|147439219|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.99|||||TWO_SIDED|95.0|-7.82|-2.15||||||||-2.15|-7.82|
73952604|NCT02036515|147439219|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.92|||||TWO_SIDED|95.0|-7.76|-2.07||||||||-2.07|-7.76|
73952605|NCT02036515|147439220|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.24|||||TWO_SIDED|95.0|-2.97|0.48||||||||0.48|-2.97|
73952606|NCT02036515|147439220|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.38|||||TWO_SIDED|95.0|-3.11|0.36||||||||0.36|-3.11|
73952607|NCT02036515|147439221|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.99|||||TWO_SIDED|95.0|-2.82|0.84||||||||0.84|-2.82|
73952608|NCT02036515|147439221|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.85|||||TWO_SIDED|95.0|-2.69|0.99||||||||0.99|-2.69|
73952609|NCT02036515|147439222|SUPERIORITY_OR_OTHER||Difference in percent|-15.1|||||TWO_SIDED|95.0|-21.9|-9.4||||||||-9.4|-21.9|
73952610|NCT02036515|147439222|SUPERIORITY_OR_OTHER||Difference in percent|-14.4|||||TWO_SIDED|95.0|-21.3|-8.5||||||||-8.5|-21.3|
73952611|NCT02036515|147439223|SUPERIORITY_OR_OTHER||Difference in percentage|-29.0|||||TWO_SIDED|95.0|-38.3|-19.4||||||||-19.4|-38.3|
73952612|NCT02036515|147439223|SUPERIORITY_OR_OTHER||Difference in percentage|-28.1|||||TWO_SIDED|95.0|-37.5|-18.4||||||||-18.4|-37.5|
73952613|NCT02036515|147439227|SUPERIORITY_OR_OTHER||Difference in least squares means|12.75|||||TWO_SIDED|95.0|6.83|18.68||||||||18.68|6.83|
73952614|NCT02036515|147439227|SUPERIORITY_OR_OTHER||Difference in least squares means|11.91|||||TWO_SIDED|95.0|5.94|17.88||||||||17.88|5.94|
73952615|NCT02036515|147439228|SUPERIORITY_OR_OTHER||Difference in least squares means|12.78|||||TWO_SIDED|95.0|6.54|19.03||||||||19.03|6.54|
73952616|NCT02036515|147439228|SUPERIORITY_OR_OTHER||Difference in least squares means|12.86|||||TWO_SIDED|95.0|6.54|19.18||||||||19.18|6.54|
73952617|NCT02036515|147439230|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||||||||0.02|-0.04|
73952618|NCT02036515|147439230|SUPERIORITY_OR_OTHER||Difference in least squares means|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||||0.04|-0.02|
73952619|NCT02036515|147439231|SUPERIORITY_OR_OTHER||Difference in least squares means|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||||0.04|-0.04|
73952620|NCT02036515|147439231|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.02|||||TWO_SIDED|95.0|-0.07|0.02||||||||0.02|-0.07|
73952621|NCT01155726|147439283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.2|1.4||||||Unmasked minus masked||1.4|-2.2|
73952622|NCT01155726|147439283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.5||||||Unmasked minus masked||2.5|-1.5|
73952623|NCT01155726|147439283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.1|2.2||||||Unmasked minus masked||2.2|-0.1|
73952624|NCT01155726|147439283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|0.2|3.5||||||Unmasked minus masked||3.5|0.2|
73952625|NCT01155726|147439283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.3|1.2||||||Partial masked minus masked||1.2|-3.3|
73952626|NCT01155726|147439283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.9|1.1||||||Partial masked minus masked||1.1|-1.9|
73952627|NCT01155726|147439283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.9|2.7||||||Partial masked minus masked||2.7|-2.9|
73952628|NCT01155726|147439283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-1.1|1.9||||||Partial masked minus masked||1.9|-1.1|
73952629|NCT03639675|147439284|OTHER||Mean change|-8.3||||0.0004|TWO_SIDED|95.0|-12.2|-4.4|||one-sample t-statistics|||||-4.4|-12.2|0.0004
73952630|NCT02459587|147439286|SUPERIORITY|Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person. VCL contacts with and without suicide ideation were combined, due to low counts.|Hazard Ratio (HR)|1.24|STANDARD_ERROR_OF_MEAN|0.222||0.33|TWO_SIDED|95.0|0.8|1.92||2-tailed P-value above was calculated from type III test.|Regression, Cox|Model was structured to allow multiple events per person. No covariates.|Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.218 (SEM=0.222)|||1.92|0.80|0.33
73952631|NCT02459587|147439287|SUPERIORITY|Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person.|Hazard Ratio (HR)|0.52|STANDARD_ERROR_OF_MEAN|0.153|<|0.0001|TWO_SIDED|95.0|0.38|0.7||All tests of significance were 2-tailed. P-value above is type III. No covariates.|Regression, Cox||Cox Proportional Hazards Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.660 (SEM=0.153)|||0.70|0.38|<0.0001
73952632|NCT02459587|147439288|SUPERIORITY|Two binary variables were derived from Treatment Services Review responses to identify any general mental health service utilization, one binary variable for Baseline and another for any outpatient mental health service utilization at any time point in the 1 year follow-up period. The Baseline variable was included as a main-effects covariate.|Odds Ratio, log|1.146||||0.66|TWO_SIDED|95.0|0.604|2.176|||Regression, Logistic|Bivariate logistic, adjusted for (1) if any general outpatient mental heath visits at baseline (0) otherwise||||2.176|0.604|0.66
73952633|NCT04731714|147439322|SUPERIORITY|||||||0.0104|||||||Mixed Models Analysis|See publication for details||||||0.0104
73979933|NCT02725372|147505118|SUPERIORITY||Mean Difference (Final Values)|-89.1||||0.01|TWO_SIDED|95.0|-156.0|-22.1|||ANCOVA|||||-22.1|-156.0|0.01
73979934|NCT02725372|147505119|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.47|TWO_SIDED|95.0|-0.89|0.41|||ANCOVA|||||0.41|-0.89|0.47
73979935|NCT02725372|147505120|SUPERIORITY||Odds Ratio (OR)|1.05||||0.26|TWO_SIDED|95.0|0.48|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.48|0.26
73979936|NCT01213940|147505127|EQUIVALENCE|95% confidence limit from standard deviation of mean|||||<|0.05|||||||ANOVA|||one -way ANOVA was used for the analysis||||<0.05
73979937|NCT00731692|147505142|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.544|TWO_SIDED|95.0|0.8|1.12|||Regression, Cox|||||1.12|0.80|0.544
73979938|NCT00108355|147505179|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Log Rank|||Initial estimation: median time to recurrence of ascites of 38 days in the study group and 20 days in the control group in a fixed duration of 6 months (5% type-I error (2 sided) and an 80% power). However, due to low accrual and based on randomized trials using vasoconstrictors in the prevention of PCD and a study that showed that midodrine leads to a significant improvement in effective arterial blood volume, each of which had sample sizes of 24-25 patients,we decided on a sample size of 30.||||<0.05
73979939|NCT00308308|147505201|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52-week data, resulting in \> 90% power for a non-inferiority test of the difference in 12-month change of HbA1c scores between treatment groups with non-inferiority margin of 0.4%, standard deviation of 1.2 and 1-sided alpha of 0.025. Allowing for a 15% dropout rate, 589 subjects were randomized.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.082|||TWO_SIDED|95.0|0.08|0.4|||ANCOVA|||||0.40|0.08|
74089422|NCT02697773|147731625|SUPERIORITY||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.25||0.0005|TWO_SIDED|95.0|-1.39|-0.39|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.39|0.0005
74089423|NCT02697773|147731628|SUPERIORITY||Least Square Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|1.56||0.6984|TWO_SIDED|95.0|-2.48|3.7|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.70|-2.48|0.6984
73952634|NCT04731714|147439323|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|See publication for details||||||0.079
73952635|NCT04731714|147439324|SUPERIORITY|||||||0.9222|||||||Mixed Models Analysis|See publication for details||||||0.9222
73952636|NCT04731714|147439325|SUPERIORITY|||||||0.7995|||||||Mixed Models Analysis|See publication for details||||||0.7995
73979940|NCT00308308|147505202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-2.7|-1.0|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate||-1.0|-2.7|<0.0001
73979941|NCT00308308|147505203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.9|STANDARD_ERROR_OF_MEAN|7.41||0.0052|TWO_SIDED|95.0|-35.4|-6.3|||ANCOVA|||||-6.3|-35.4|0.0052
73979942|NCT00308308|147505204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.941||||0.8311|TWO_SIDED|95.0|0.536|1.652|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model||1.652|0.536|0.8311
73979943|NCT00308308|147505205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.488||||0.0124|TWO_SIDED|95.0|0.278|0.856|||Regression, Logistic||Model: Treatment + Site|||0.856|0.278|0.0124
73979944|NCT00308308|147505206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.825||||0.2786|TWO_SIDED|95.0|0.582|1.169|||Regression, Logistic||Model: Treatment + Site|||1.169|0.582|0.2786
73979945|NCT00308308|147505207|SUPERIORITY_OR_OTHER|||||||0.1193|||||||Generalized Estimation Equation|"* Based on Poisson distribution~* Model: Treatment + Time Period"||||||0.1193
73952637|NCT04731714|147439326|OTHER|||||||0.314||||||rhythmic days|Friedman Test|See publication for further details||||||0.3140
73979946|NCT00308308|147505208|SUPERIORITY_OR_OTHER|||||||0.2131|||||||Generalized Estimating Equation|"* Based on Poisson distribution~* Model: Treatment + Time Period"||||||0.2131
73979947|NCT01686152|147505209|EQUIVALENCE|The test product was determined to be bioequivalent to the reference product if the 90% confidence interval was within -0.20 to 0.20.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|90.0|-0.0663|0.0913||||||||0.0913|-0.0663|
73979948|NCT01853384|147505210|SUPERIORITY_OR_OTHER|||||||0.5348||||||Analysis adjusted for sites, with significance being at P \< 0.05|Cochran-Mantel-Haenszel|||||||.5348
73952638|NCT04731714|147439326|OTHER|||||||0.239||||||arrhythmic days|Friedman Test|See publication for further details||||||0.239
73952639|NCT04731714|147439330|SUPERIORITY|||||||0.8844|||||||Mixed Models Analysis|See publication for details||||||0.8844
73952640|NCT04731714|147439332|OTHER|||||||0.73|||||||binomial|One-sided||||||0.73
73952641|NCT02033993|147439374|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.31|TWO_SIDED|90.0|0.68|1.23||1-sided p-value|Log Rank|||||1.23|0.68|0.31
73952642|NCT02033993|147439375|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.4|TWO_SIDED|90.0|0.7|1.3||1-sided p-value|Log Rank|||||1.30|0.70|0.40
73952643|NCT02033993|147439376|SUPERIORITY||Odds Ratio (OR)|1.41||||0.28|TWO_SIDED|95.0|0.76|2.59|||Cochran-Mantel-Haenszel|||||2.59|0.76|0.28
73952644|NCT02033993|147439377|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.54|TWO_SIDED|95.0|0.46|1.51|||Log Rank|||||1.51|0.46|0.54
73979949|NCT01853384|147505211|SUPERIORITY_OR_OTHER|||||||0.9456|||||||Regression, Cox|||||||.9456
73979950|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.6194||||||Treatment Week 01|Cochran-Mantel-Haenszel|||||||.6194
73979951|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.793||||||Treatment Week 02|Cochran-Mantel-Haenszel|||||||.7930
73979952|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.3362||||||Treatment Week 03|Cochran-Mantel-Haenszel|||||||0.3362
73979953|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.5263||||||Treatment Week 04|Cochran-Mantel-Haenszel|||||||0.5263
73979954|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.1997||||||Treatment Week 05|Cochran-Mantel-Haenszel|||||||0.1997
73979955|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.1617||||||Treatment Week 06|Cochran-Mantel-Haenszel|||||||0.1617
73872137|NCT01514201|147287453|OTHER|This was descriptive in nature. Two of the first 5 patients who were escalated to 175 mg/m2 of temozolomide during the maintenance intra-patient dose escalation had dose-modifying toxicities (DMTs). Since the ad hoc stopping rule was met, intra-patient dose escalation was halted and all subsequent patients were to receive 135 mg/m2 of temozolomide during maintenance.|Percentage of patients with DMTs|40.0|||||TWO_SIDED|||||||||Intra-patient dose escalation of temozolomide during maintenance was assessed based on similar rules employed in traditional 3+3 designs. For example intra-patient dose escalation would be halted if at any time 2 out of first 2-6 patients experienced dose-modifying toxicities at a given dose level or if 4 out of first 12 patients experienced dose-modifying toxicities at a given dose level.||||
73872138|NCT02534909|147287499|OTHER|Bayesian analysis of response rate in serum LDH (period 1 completers only)|Median response rate|99.0|||||TWO_SIDED|95.0|81.9|100.0|||||95% Credibility Interval for Response Rate|Up to Week 4||100.0|81.9|
73952645|NCT02264574|147439379|SUPERIORITY||Hazard Ratio (HR)|0.231|||<|0.0001|TWO_SIDED|95.0|0.145|0.367|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||0.367|0.145|<0.0001
73952646|NCT02264574|147439380|SUPERIORITY||Hazard Ratio (HR)|0.119|||<|0.0001|TWO_SIDED|95.0|0.046|0.307|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||0.307|0.046|< 0.0001
73952647|NCT02264574|147439381|SUPERIORITY|||||||0.5253|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.5253
73952648|NCT02264574|147439382|SUPERIORITY|||||||0.5465|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.5465
73952649|NCT02264574|147439383|SUPERIORITY||Rate Ratio|1.208||||0.0035|TWO_SIDED|95.0|1.062|1.373|||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||1.373|1.062|0.0035
73952650|NCT02264574|147439384|SUPERIORITY||Hazard Ratio (HR)|0.921||||0.8057|TWO_SIDED|95.0|0.479|1.772|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||1.772|0.479|0.8057
73952651|NCT02264574|147439385|SUPERIORITY|||||||0.0835|||||||Fisher Exact|||"IRR Preferred Term~To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record."||||0.0835
73952652|NCT02264574|147439385|SUPERIORITY|||||||0.1944|||||||Fisher Exact|||"IRR By Customized SMQ~To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record."||||0.1944
73979956|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.2611||||||Treatment Week 07|Cochran-Mantel-Haenszel|||||||0.2611
73979957|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.7232||||||Treatment Week 08|Cochran-Mantel-Haenszel|||||||0.7232
73979958|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.4405||||||Treatment Week 09|Cochran-Mantel-Haenszel|||||||0.4405
73952653|NCT02264574|147439386|SUPERIORITY|||||||0.0045|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.0045
73979959|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.3516||||||Treatment Week 10|Cochran-Mantel-Haenszel|||||||0.3516
73979960|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.2821||||||Treatment Week 11|Cochran-Mantel-Haenszel|||||||0.2821
73872139|NCT02534909|147287500|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.23|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 1 Day 29 serum LDH levels||0.23|0.15|<0.001
73872140|NCT02534909|147287500|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.23|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 2 Day 365 serum LDH levels||0.23|0.15|<0.001
73979961|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.3722||||||Treatment Week 12|Cochran-Mantel-Haenszel|||||||0.3722
73979962|NCT01853384|147505213|SUPERIORITY_OR_OTHER|||||||0.5348||||||Week 12 - Primary Endpoint|Cochran-Mantel-Haenszel|||||||0.5348
73979963|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.5909||||||Week 01|ANCOVA|||||||0.5909
73979964|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.8234||||||Week 02|ANCOVA|||||||0.8234
73979965|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.1556||||||Week 03|ANCOVA|||||||0.1556
73979966|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.3487||||||Week 04|ANCOVA|||||||0.3487
73979967|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.1064||||||Week 05|ANCOVA|||||||0.1064
73872141|NCT02534909|147287500|OTHER||Geometric LS mean Ratio to Baseline|0.17|||<|0.001|TWO_SIDED|95.0|0.14|0.2|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 3 Day 1429 serum LDH levels||0.20|0.14|<0.001
73872142|NCT02534909|147287500|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 4 Day 141 serum LDH levels||0.24|0.15|<0.001
73872143|NCT00577824|147287512|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni's method was used to adjustment for multiplicity, and significant level was set to 2.5%(two-sided).|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as the covariate.||||||<0.001
73952654|NCT02264574|147439387|SUPERIORITY|||||||0.859|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.8590
73952655|NCT02264574|147439388|SUPERIORITY||Hazard Ratio (HR)|0.169|||<|0.0001|TWO_SIDED|95.0|0.102|0.282|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||0.282|0.102|< 0.0001
73952656|NCT02264574|147439389|SUPERIORITY|||||||0.9657|||||||Chi-squared|||||||0.9657
73952657|NCT02264574|147439390|SUPERIORITY|||||||0.1612|||||||Chi-squared|||||||0.1612
73952658|NCT02264574|147439391|SUPERIORITY||Rate Ratio|1.125||||0.0273|TWO_SIDED|95.0|1.013|1.25|||Chi-squared|||||1.250|1.013|0.0273
73952659|NCT02264574|147439392|SUPERIORITY||Hazard Ratio (HR)|1.083||||0.7934|TWO_SIDED|95.0|0.595|1.973|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||1.973|0.595|0.7934
73952660|NCT02264574|147439393|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.0050
73979968|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.2888||||||Week 06|ANCOVA|||||||0.2888
73979969|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.6095||||||Week 07|ANCOVA|||||||0.6095
74089424|NCT02697773|147731628|SUPERIORITY||Least Square Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|1.6||0.2953|TWO_SIDED|95.0|-4.84|1.48|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||1.48|-4.84|0.2953
73872144|NCT00577824|147287513|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage|||||||<0.001
73952661|NCT02264574|147439394|SUPERIORITY||Hazard Ratio (HR)|0.251|||<|0.0001|TWO_SIDED|95.0|0.162|0.389|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||0.389|0.162|< 0.0001
73872145|NCT00577824|147287514|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage|||||||<0.001
73872146|NCT00577824|147287515|SUPERIORITY_OR_OTHER||||||<|0.002||95.0||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA|||||||<0.002
73872147|NCT00577824|147287516|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA|||||||0.026
73952662|NCT02886728|147439402|SUPERIORITY||Difference in Response Rates|9.6|||<|0.001|TWO_SIDED|95.0|3.6|15.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||15.6|3.6|<0.001
73952663|NCT02886728|147439402|SUPERIORITY||Difference in Response Rates|8.8||||0.017|TWO_SIDED|95.0|1.5|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||16.1|1.5|0.017
73952664|NCT02886728|147439402|SUPERIORITY||Difference in Response Rates|6.7||||0.058|TWO_SIDED|95.0|-0.7|14.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||14.1|-0.7|0.058
73952665|NCT02886728|147439403|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.041|<|0.001|TWO_SIDED|95.0|-0.27|-0.11||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.27|<0.001
73979970|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.1566||||||Week 08|ANCOVA|||||||0.1566
73872148|NCT00577824|147287517|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||t-test, 2 sided|||||||0.672
73872149|NCT00577824|147287518|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||t-test, 2 sided|||||||0.580
73979971|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.4216||||||Week 09|ANCOVA|||||||0.4216
73979972|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.8166||||||Week10|ANCOVA|||||||0.8166
73979973|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.9114||||||Week 11|ANCOVA|||||||0.9114
73872150|NCT00577824|147287519|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
73872151|NCT00577824|147287520|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.490
73872152|NCT00577824|147287521|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
73872153|NCT00577824|147287522|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||t-test, 2 sided|||||||0.208
73979974|NCT01853384|147505215|SUPERIORITY_OR_OTHER|||||||0.9733||||||Week 12|ANCOVA|||||||0.9733
73979975|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.7439||||||Week 01|ANCOVA|||||||0.7439
73979976|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.6992||||||Week 02|ANCOVA|||||||0.6992
73979977|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.0867||||||Week 03|ANCOVA|||||||0.0867
73952666|NCT02886728|147439403|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.049||0.009|TWO_SIDED|95.0|-0.23|-0.03||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.03|-0.23|0.009
73979978|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.5739||||||Week 04|ANCOVA|||||||0.5739
73872154|NCT00577824|147287524|SUPERIORITY_OR_OTHER|||||||0.708||95.0|||||t-test, 2 sided|||||||0.708
73872155|NCT00577824|147287525|SUPERIORITY_OR_OTHER|||||||0.974||95.0|||||t-test, 2 sided|||||||0.974
73979979|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.6497||||||Week 05|ANCOVA|||||||0.6497
73979980|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.1427||||||Week 06|ANCOVA|||||||0.1427
73979981|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.0682||||||Week 07|ANCOVA|||||||0.0682
73979982|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.0161||||||Week 08|ANCOVA|||||||0.0161
73979983|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.0973||||||Week 09|ANCOVA|||||||0.0973
73979984|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.4661||||||Week 10|ANCOVA|||||||0.4661
73979985|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.601||||||Week 11|ANCOVA|||||||0.6010
73979986|NCT01853384|147505216|SUPERIORITY_OR_OTHER|||||||0.3369||||||Week 12|ANCOVA|||||||0.3369
73979987|NCT01802333|147505217|OTHER|||||||0.84|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.||||0.84
73979988|NCT01802333|147505217|OTHER|||||||0.42|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm II was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.||||0.42
73979989|NCT01802333|147505218|OTHER||||||<|0.0001|||||||Exact binomial test, 1-sided|||||||<0.0001
73979990|NCT01802333|147505220|OTHER|||||||0.52|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm II using a two-sided test of the null hypothesis (HR=1).||||0.52
73872156|NCT00577824|147287527|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 2 sided|||||||0.200
73872157|NCT00577824|147287528|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73872158|NCT00362648|147287529|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|39.3|||<|0.001||95.0|19.1|54.7||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.||54.7|19.1|<0.001
73979991|NCT01947491|147505228|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73979992|NCT03137784|147505245|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.089|||<|0.001|TWO_SIDED|95.0|0.047|0.132|||Linear Mixed Model|||||0.132|0.047|<0.001
73979993|NCT03137784|147505245|OTHER||Linear Mixed Model (LMM)|0.09|||<|0.001|TWO_SIDED|95.0|0.047|0.132|||Linear Mixed Model|||||0.132|0.047|<0.001
73979994|NCT03137784|147505246|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.165|||<|0.001|TWO_SIDED|95.0|0.127|0.203|||Linear Mixed Model|||||0.203|0.127|<0.001
73979995|NCT03137784|147505246|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.168|||<|0.001|TWO_SIDED|95.0|0.129|0.206|||Linear Mixed Model|||||0.206|0.129|<0.001
73979996|NCT03137784|147505247|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.176|||<|0.001|TWO_SIDED|95.0|0.141|0.212|||Linear Mixed Model|||||0.212|0.141|<0.001
73979997|NCT03137784|147505247|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.179|||<|0.001|TWO_SIDED|95.0|0.144|0.215|||Linear Mixed Model|||||0.215|0.144|<0.001
73979998|NCT03137784|147505248|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.139|||<|0.001|TWO_SIDED|95.0|0.106|0.173|||Linear Mixed Model|||||0.173|0.106|<0.001
73979999|NCT03137784|147505248|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.146|||<|0.001|TWO_SIDED|95.0|0.112|0.179|||Linear Mixed Model|||||0.179|0.112|<0.001
73980000|NCT03137784|147505249|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.164|||<|0.001|TWO_SIDED|95.0|0.127|0.201|||Linear Mixed Model|||||0.201|0.127|<0.001
73980001|NCT03137784|147505249|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.174|||<|0.001|TWO_SIDED|95.0|0.137|0.211|||Linear Mixed Model|||||0.211|0.137|<0.001
73980002|NCT03137784|147505250|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.036||||0.079|TWO_SIDED|95.0|-0.004|0.077|||Linear Mixed Model|||||0.077|-0.004|0.079
73980003|NCT03137784|147505250|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.058||||0.006|TWO_SIDED|95.0|0.017|0.099|||Linear Mixed Model|||||0.099|0.017|0.006
73980004|NCT03137784|147505252|OTHER|Treatment difference|Linear Mixed Model (LMM)|25.51|||<|0.001|TWO_SIDED|95.0|19.22|31.79|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||31.79|19.22|<0.001
73980005|NCT03137784|147505252|OTHER|Treatment difference|Linear Mixed Model (LMM)|24.29|||<|0.001|TWO_SIDED|95.0|17.99|30.59|||Linear Mixed Model|||||30.59|17.99|<0.001
73980006|NCT03137784|147505253|OTHER|Treatment difference|Linear Mixed Model (LMM)|30.95|||<|0.001|TWO_SIDED|95.0|25.07|36.82|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||36.82|25.07|<0.001
74032966|NCT04525222|147618907|OTHER||Slope|2.92||||0.75|TWO_SIDED|95.0|-15.22|21.07|||Negative Binomial Regression|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||21.07|-15.22|0.75
73952667|NCT02886728|147439403|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.032|TWO_SIDED|95.0|-0.2|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.20|0.032
73952668|NCT02886728|147439404|SUPERIORITY||Difference in Response Rates|25.0|||<|0.001|TWO_SIDED|95.0|18.3|31.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||31.7|18.3|<0.001
73952669|NCT02886728|147439404|SUPERIORITY||Difference in Response Rates|13.4|||<|0.001|TWO_SIDED|95.0|5.0|21.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||21.8|5.0|<0.001
73952670|NCT02886728|147439404|SUPERIORITY||Difference in Response Rates|13.3|||<|0.001|TWO_SIDED|95.0|5.0|21.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||21.6|5.0|<0.001
73952671|NCT02886728|147439405|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.161||0.068|TWO_SIDED|95.0|-0.61|0.02||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.02|-0.61|0.068
73952672|NCT02886728|147439405|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.195||0.14|TWO_SIDED|95.0|-0.67|0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.10|-0.67|0.14
73952673|NCT02886728|147439405|SUPERIORITY||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.199||0.006|TWO_SIDED|95.0|-0.94|-0.16||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.16|-0.94|0.006
73952674|NCT02886728|147439406|SUPERIORITY||Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|1.8|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|1.8|<0.001
73952675|NCT02886728|147439406|SUPERIORITY||Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.69||0.021|TWO_SIDED|95.0|0.2|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.2|0.021
73952676|NCT02886728|147439406|SUPERIORITY||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.69||0.24|TWO_SIDED|95.0|-0.5|2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.2|-0.5|0.24
73952677|NCT02886728|147439407|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.68||0.056|TWO_SIDED|95.0|0.0|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|-0.0|0.056
73980007|NCT03137784|147505253|OTHER|Treatment difference|Linear Mixed Model (LMM)|29.37|||<|0.001|TWO_SIDED|95.0|23.47|35.26|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||35.26|23.47|<0.001
73952678|NCT02886728|147439407|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.82||0.1|TWO_SIDED|95.0|-0.3|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-0.3|0.10
73952679|NCT02886728|147439407|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.83||0.67|TWO_SIDED|95.0|-1.3|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-1.3|0.67
73980008|NCT03137784|147505254|OTHER|Treatment difference|Linear Mixed Model (LMM)|-0.15||||0.053|TWO_SIDED|95.0|-0.31|0.0|||Linear Mixed Model|||||0.00|-0.31|0.053
73980009|NCT03137784|147505254|OTHER|Treatment difference|Linear Mixed Model (LMM)|-0.11||||0.163|TWO_SIDED|95.0|-0.27|0.05|||Linear Mixed Model|||||0.05|-0.27|0.163
73952680|NCT02886728|147439408|SUPERIORITY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.195|<|0.001|TWO_SIDED|95.0|-1.03|-0.27||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.27|-1.03|<0.001
73952681|NCT02886728|147439408|SUPERIORITY||Least Squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.236||0.008|TWO_SIDED|95.0|-1.09|-0.16||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.16|-1.09|0.008
73952682|NCT02886728|147439408|SUPERIORITY||Least Squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.242||0.006|TWO_SIDED|95.0|-1.14|-0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-1.14|0.006
73952683|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|25.5|||<|0.001|TWO_SIDED|95.0|19.3|31.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||31.7|19.3|<0.001
73952684|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|20.6|||<|0.001|TWO_SIDED|95.0|12.8|28.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||28.5|12.8|<0.001
73952685|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|22.9|||<|0.001|TWO_SIDED|95.0|15.1|30.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||30.8|15.1|<0.001
73952686|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|28.8|||<|0.001|TWO_SIDED|95.0|22.1|35.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||35.6|22.1|<0.001
73952687|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|22.1|||<|0.001|TWO_SIDED|95.0|13.6|30.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||30.7|13.6|<0.001
73952688|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|19.0|||<|0.001|TWO_SIDED|95.0|10.5|27.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||27.5|10.5|<0.001
73952689|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|17.3|||<|0.001|TWO_SIDED|95.0|10.8|23.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||23.8|10.8|<0.001
73952690|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|12.6||||0.002|TWO_SIDED|95.0|4.5|20.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||20.7|4.5|0.002
73952691|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|12.1||||0.002|TWO_SIDED|95.0|4.0|20.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||20.1|4.0|0.002
73952692|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|7.2||||0.016|TWO_SIDED|95.0|0.9|13.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||13.5|0.9|0.016
73952693|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|5.2||||0.18|TWO_SIDED|95.0|-2.7|13.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||13.0|-2.7|0.18
73952694|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|7.9||||0.03|TWO_SIDED|95.0|0.3|15.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||15.6|0.3|0.030
73952695|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|13.2|||<|0.001|TWO_SIDED|95.0|6.7|19.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||19.7|6.7|<0.001
73952696|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|11.7||||0.003|TWO_SIDED|95.0|3.7|19.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||19.6|3.7|0.003
73952697|NCT02886728|147439409|SUPERIORITY||Difference in Response Rates|13.0|||<|0.001|TWO_SIDED|95.0|5.1|20.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||20.8|5.1|<0.001
73980010|NCT01205126|147505268|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.855|TWO_SIDED|95.0|-1.3|1.1||P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.|ANCOVA|||||1.1|-1.3|0.855
73952698|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|10.1|||<|0.001|TWO_SIDED|95.0|6.2|13.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||13.9|6.2|<0.001
73952699|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|6.3||||0.001|TWO_SIDED|95.0|1.7|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||10.9|1.7|0.001
73952700|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|13.3|||<|0.001|TWO_SIDED|95.0|7.7|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||18.9|7.7|<0.001
73952701|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|20.0|||<|0.001|TWO_SIDED|95.0|14.5|25.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||25.4|14.5|<0.001
73952702|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|11.4|||<|0.001|TWO_SIDED|95.0|4.8|18.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||18.0|4.8|<0.001
73952703|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|9.4|23.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||23.2|9.4|<0.001
73952704|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|24.8|||<|0.001|TWO_SIDED|95.0|18.1|31.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||31.5|18.1|<0.001
73952705|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|16.1|||<|0.001|TWO_SIDED|95.0|7.7|24.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||24.5|7.7|<0.001
73952706|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|17.3|||<|0.001|TWO_SIDED|95.0|9.0|25.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||25.7|9.0|<0.001
73952707|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|15.9|||<|0.001|TWO_SIDED|95.0|8.9|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||22.8|8.9|<0.001
73952708|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|11.3||||0.006|TWO_SIDED|95.0|2.7|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||20.0|2.7|0.006
73952709|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|12.4||||0.002|TWO_SIDED|95.0|3.9|21.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||21.0|3.9|0.002
73952710|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|12.0|||<|0.001|TWO_SIDED|95.0|5.1|19.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||19.0|5.1|<0.001
73952711|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|7.0||||0.09|TWO_SIDED|95.0|-1.7|15.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||15.7|-1.7|0.090
73952712|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|10.0||||0.014|TWO_SIDED|95.0|1.4|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||18.6|1.4|0.014
74032967|NCT04525222|147618908|OTHER||Odds Ratio (OR)|1.33||||0.55|TWO_SIDED|95.0|0.5|3.48|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.48|0.5|0.55
73952713|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|13.9|||<|0.001|TWO_SIDED|95.0|7.0|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||20.9|7.0|<0.001
73952714|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|11.1||||0.008|TWO_SIDED|95.0|2.5|19.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||19.7|2.5|0.008
73952715|NCT02886728|147439410|SUPERIORITY||Difference in Response Rates|13.1||||0.001|TWO_SIDED|95.0|4.6|21.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||21.6|4.6|0.001
73952716|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|2.4||||0.018|TWO_SIDED|95.0|0.3|4.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||4.5|0.3|0.018
73952717|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|1.2||||0.17|TWO_SIDED|95.0|-1.2|3.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||3.6|-1.2|0.17
73952718|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|3.6||||0.004|TWO_SIDED|95.0|0.3|6.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||6.8|0.3|0.004
73952719|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|9.1|||<|0.001|TWO_SIDED|95.0|5.2|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||13.1|5.2|<0.001
74032968|NCT04525222|147618909|OTHER||Odds Ratio (OR)|1.63||||0.17|TWO_SIDED|95.0|0.8|3.32|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking \<20 Cigs/ \>=20 Cigs, Baseline Depression Severity PHQ-8\<5 / PHQ-8\>=5||||3.32|0.80|0.17
74032969|NCT04525222|147618910|OTHER||Odds Ratio (OR)|1.63||||0.25|TWO_SIDED|95.0|0.7|3.81|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.81|0.70|0.25
73952720|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|2.4||||0.18|TWO_SIDED|95.0|-1.7|6.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||6.6|-1.7|0.18
73952721|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|7.6|||<|0.001|TWO_SIDED|95.0|2.5|12.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||12.6|2.5|<0.001
73952722|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|19.7|||<|0.001|TWO_SIDED|95.0|13.9|25.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||25.5|13.9|<0.001
73952723|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|6.6|21.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||21.1|6.6|<0.001
73952724|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|15.8|||<|0.001|TWO_SIDED|95.0|8.5|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||23.1|8.5|<0.001
73980011|NCT01205126|147505269|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.615|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||0.6|-1.0|0.615
73980012|NCT01205126|147505270|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.621|TWO_SIDED|95.0|-1.1|0.7|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||0.7|-1.1|0.621
73980013|NCT01205126|147505271|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.832|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||||0.832
73980014|NCT01205126|147505272|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.304|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29||||||0.304
73980015|NCT01205126|147505273|SUPERIORITY_OR_OTHER|||||||0.276|||||||rank sum test, 2 sided|||||||0.276
73980016|NCT00486954|147505275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2088|TWO_SIDED|95.0|0.64|1.11|||Log Rank|||||1.11|0.64|0.2088
73980017|NCT01836523|147505319|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.2|||||TWO_SIDED|95.0|-0.32|-0.07||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-0.07|-0.32|
74032970|NCT04525222|147618911|OTHER||Odds Ratio (OR)|1.88||||0.07|TWO_SIDED|95.0|0.94|3.72||Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)|Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.72|0.94|0.07
74032971|NCT04525222|147618912|OTHER||Odds Ratio (OR)|2.42||||0.04|TWO_SIDED|95.0|1.0|5.85|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||5.85|1.00|0.04
74032972|NCT04525222|147618913|OTHER||Odds Ratio (OR)|1.47||||0.25|TWO_SIDED|95.0|0.75|2.89|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||2.89|0.75|0.25
74032973|NCT04525222|147618914|OTHER||Odds Ratio (OR)|1.78||||0.17|TWO_SIDED|95.0|0.77|4.12|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.12|0.77|0.17
74032974|NCT04525222|147618915|OTHER||Odds Ratio (OR)|1.91||||0.15|TWO_SIDED|95.0|0.77|4.73|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.73|0.77|0.15
74032975|NCT04525222|147618916|OTHER||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.41|3.86|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.86|0.41|0.68
74032976|NCT04525222|147618917|OTHER||Odds Ratio (OR)|1.63||||0.21|TWO_SIDED|95.0|0.75|3.46|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.46|0.75|0.21
74032977|NCT04525222|147618918|OTHER||Odds Ratio (OR)|1.63||||0.3|TWO_SIDED|95.0|0.63|4.19|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.19|0.63|0.30
73952725|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|17.8|||<|0.001|TWO_SIDED|95.0|11.2|24.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||24.4|11.2|<0.001
73952726|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|5.9|22.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||22.4|5.9|<0.001
73952727|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|14.0|||<|0.001|TWO_SIDED|95.0|5.8|22.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||22.2|5.8|<0.001
73952728|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|13.7|||<|0.001|TWO_SIDED|95.0|6.9|20.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||20.5|6.9|<0.001
73952729|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|5.0||||0.2|TWO_SIDED|95.0|-3.3|13.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||13.3|-3.3|0.20
73952730|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|7.3||||0.056|TWO_SIDED|95.0|-1.0|15.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||15.7|-1.0|0.056
73952731|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|18.0|||<|0.001|TWO_SIDED|95.0|11.3|24.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||24.8|11.3|<0.001
73952732|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|10.3||||0.01|TWO_SIDED|95.0|1.9|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||18.6|1.9|0.010
73952733|NCT02886728|147439411|SUPERIORITY||Difference in Response Rates|15.4|||<|0.001|TWO_SIDED|95.0|7.0|23.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||23.8|7.0|<0.001
73952734|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.031|<|0.001|TWO_SIDED|95.0|-0.29|-0.17||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.17|-0.29|<0.001
73952735|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.038|<|0.001|TWO_SIDED|95.0|-0.28|-0.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.13|-0.28|<0.001
73952736|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.038|<|0.001|TWO_SIDED|95.0|-0.24|-0.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.09|-0.24|<0.001
73952737|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.035|<|0.001|TWO_SIDED|95.0|-0.35|-0.22||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.22|-0.35|<0.001
73952738|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.043|<|0.001|TWO_SIDED|95.0|-0.23|-0.06||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.06|-0.23|<0.001
73952739|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.042|<|0.001|TWO_SIDED|95.0|-0.29|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.29|<0.001
73980018|NCT01836523|147505319|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.15|||||TWO_SIDED|95.0|-0.27|-0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-0.03|-0.27|
74032978|NCT04525222|147618919|OTHER||Slope|-1.68||||0.0072|TWO_SIDED|95.0|-2.9|-0.46|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||-0.46|-2.90|.0072
73952740|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.039|<|0.001|TWO_SIDED|95.0|-0.35|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.20|-0.35|<0.001
73952741|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.28|-0.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.09|-0.28|<0.001
73952742|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.26|-0.07||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.07|-0.26|<0.001
73952743|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.043||0.002|TWO_SIDED|95.0|-0.22|-0.05||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.05|-0.22|0.002
73952744|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.052||0.23|TWO_SIDED|95.0|-0.17|0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.04|-0.17|0.23
73952745|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.052||0.24|TWO_SIDED|95.0|-0.16|0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.04|-0.16|0.24
73952746|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|95.0|-0.25|-0.08||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.08|-0.25|<0.001
73952747|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.054||0.077|TWO_SIDED|95.0|-0.2|0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.01|-0.20|0.077
73952748|NCT02886728|147439412|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.054||0.039|TWO_SIDED|95.0|-0.22|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.22|0.039
73952749|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-6.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.0|<0.001
73952750|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-6.0|<0.001
73980019|NCT01836523|147505319|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.09|||||TWO_SIDED|95.0|-0.21|0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||0.03|-0.21|
74032979|NCT04525222|147618920|OTHER||Odds Ratio (OR)|1.829||||0.177|TWO_SIDED|95.0|0.77|4.344|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.344|0.770|0.1770
73872159|NCT00362648|147287529|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|48.3|||<|0.001||95.0|22.3|66.1||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.||66.1|22.3|<0.001
73872160|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|78.3||||||95.0|71.7|84.0||||||Anti-rotavirus IgA||84.0|71.7|
73872161|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|18.5||||||95.0|13.3|24.8||||||Serotype G1||24.8|13.3|
73952751|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
73952752|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-7.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-7.0|<0.001
73952753|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.0|<0.001
73952754|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
73952755|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
73952756|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
73980020|NCT01836523|147505320|SUPERIORITY_OR_OTHER||Treatment difference|-4.9|||<|0.0001|TWO_SIDED|95.0|-5.65|-4.16|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-4.16|-5.65|<0.0001
73980021|NCT01836523|147505320|SUPERIORITY_OR_OTHER||Treatment difference|-3.55|||<|0.0001|TWO_SIDED|95.0|-4.29|-2.81|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-2.81|-4.29|<0.0001
73980022|NCT01836523|147505320|SUPERIORITY_OR_OTHER||Treatment difference|-2.19|||<|0.0001|TWO_SIDED|95.0|-2.91|-1.47|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-1.47|-2.91|<0.0001
74032980|NCT04525222|147618921|OTHER||Slope|3.62||||0.0025|TWO_SIDED|95.0|1.28|5.95|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression, Baseline Activation Score||||5.95|1.28|0.0025
74032981|NCT00320385|147618940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.008|TWO_SIDED|95.0|0.57|0.93|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.|||0.93|0.57|0.008
73872162|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|9.0||||||95.0|5.3|14.0||||||Serotype G2||14.0|5.3|
73872163|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|6.3||||||95.0|3.3|10.8||||||Serotype G3||10.8|3.3|
73952757|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-6.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-6.0|<0.001
73952758|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
73952759|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.005|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|0.005
73952760|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
73952761|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.063|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-2.0|0.063
73872164|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|26.5||||||95.0|20.3|33.3||||||Serotype G4||33.3|20.3|
73952762|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.6||0.64|TWO_SIDED|95.0|-1.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-1.0|0.64
73952763|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
73952764|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
73952765|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.095|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-2.0|0.095
73952766|NCT02886728|147439413|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
73980023|NCT01836523|147505321|SUPERIORITY_OR_OTHER||Treatment ratio|0.92|||<|0.0001|TWO_SIDED|95.0|0.88|0.96|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||0.96|0.88|<0.0001
74032982|NCT00320385|147618941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.106|TWO_SIDED|95.0|0.53|1.07|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.|||1.07|0.53|0.106
73872165|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|14.4||||||95.0|9.7|20.2||||||Serotype P1A\[8\]||20.2|9.7|
73872166|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|20.1||||||95.0|14.4|27.0||||||Anti-rotavirus IgA||27.0|14.4|
73872167|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|0.0||||||95.0|0.0|2.2||||||Serotype G1||2.2|0.0|
73872168|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|3.0||||||95.0|1.0|6.8||||||Serotype G2||6.8|1.0|
73872169|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G3||5.9|0.6|
73952767|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
73952768|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.002|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|0.002
73952769|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
73952770|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
73952771|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
73952772|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
73952773|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-3.0|<0.001
73952774|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
73952775|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
73952776|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
73952777|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
73980024|NCT01836523|147505321|SUPERIORITY_OR_OTHER||Treatment ratio|0.95||||0.0148|TWO_SIDED|95.0|0.91|0.99|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||0.99|0.91|0.0148
74032983|NCT00320385|147618942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.46|TWO_SIDED|95.0|0.6|3.9|||Fisher Exact||Responses were compared between treatment arms using stratified Fisher's exact tests.|||3.9|0.6|0.460
74032984|NCT00320385|147618943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.01|TWO_SIDED|95.0|1.2|4.5|||Fisher Exact||Clinical Benefit was compared between treatment arms using stratified Fisher's exact tests.|||4.5|1.2|0.010
73952778|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
73952779|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|<0.001
73952780|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.12|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-1.0|0.12
73952781|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.019|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|0.019
73952782|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
73952783|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.032|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|0.032
73952784|NCT02886728|147439414|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|<0.001
73952785|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-13.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-13.0|<0.001
73952786|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-10.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-10.0|<0.001
74032985|NCT02492750|147618948|OTHER||Maximum Tolerated Dose (MTD) Level|3.0|||||TWO_SIDED||||||||MTD is defined as the dose level below the lowest dose that induces DLT in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.|||||
73872170|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G4||5.9|0.6|
73872171|NCT00362648|147287530|SUPERIORITY_OR_OTHER||Percentage|4.7||||||95.0|2.1|9.1||||||Serotype P1A\[8\]||9.1|2.1|
73872172|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|87.8||||||95.0|80.9|92.9||||||Anti-rotavirus IgA||92.9|80.9|
73872173|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|32.1||||||95.0|24.2|40.8||||||Serotype G1||40.8|24.2|
73872174|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|9.9||||||95.0|5.4|16.4||||||Serotype G2||16.4|5.4|
73872175|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|28.2||||||95.0|20.7|36.8||||||Serotype G3||36.8|20.7|
73872176|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|18.3||||||95.0|12.1|26.0||||||Serotype G4||26.0|12.1|
73872177|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|27.5||||||95.0|20.0|36.0||||||Serotype P1A\[8\]||36.0|20.0|
73872178|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|18.2||||||95.0|12.0|25.8||||||Anti-rotavirus IgA||25.8|12.0|
73872179|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|2.3||||||95.0|0.5|6.5||||||Serotype G1||6.5|0.5|
73872180|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|0.8||||||95.0|0.0|4.1||||||Serotype G2||4.1|0.0|
73872181|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|3.0||||||95.0|0.8|7.6||||||Serotype G3||7.6|0.8|
73872182|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|0.0||||||95.0|0.0|2.8||||||Serotype G4||2.8|0.0|
73872183|NCT00362648|147287531|SUPERIORITY_OR_OTHER||Percentage|5.3||||||95.0|2.2|10.6||||||Serotype P1A\[8\]||10.6|2.2|
73872184|NCT02058563|147287576|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.91|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 1790.2 (LL=1669.6;UL=1919.5) and 1781.5 (LL=1661.8;UL=1909.7) respectively|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed||1.11|0.91|
73872185|NCT02058563|147287577|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.05|||||TWO_SIDED|95.0|0.96|1.16|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 113.5 (LL=106.0;UL=121.6) and 107.8 (LL=100.7;UL=115.4) respectively.|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed.||1.16|0.96|
73872186|NCT02058563|147287578|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 76.1 (LL=71.5;UL=81.0) and 74.6 (LL=70.2;UL=79.4) respectively.|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed||1.11|0.93|
73872187|NCT04522141|147287595|OTHER|||||||0.038||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.038
73872188|NCT04522141|147287595|SUPERIORITY|||||||0.941||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.941
73872189|NCT04522141|147287596|OTHER|||||||0.003||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.003
73872190|NCT04522141|147287596|SUPERIORITY|||||||0.027||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.027
73872191|NCT04522141|147287597|OTHER||||||<|0.001||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||< .001
73872192|NCT04522141|147287597|SUPERIORITY|||||||0.411||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.411
73872193|NCT04522141|147287598|OTHER||||||<|0.001||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status|Mixed Models Analysis|||Main effect weekly self-control||||< .001
73872194|NCT04522141|147287598|SUPERIORITY|||||||0.176||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status|Mixed Models Analysis|||Time by condition interaction weekly self-control||||0.176
73872195|NCT04522141|147287599|OTHER||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||> .05
73872196|NCT04522141|147287599|SUPERIORITY||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||> .05
73872197|NCT04522141|147287600|OTHER|||||||0.031||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.031
73872198|NCT04522141|147287600|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.||Time by condition interaction||||0.260
73872199|NCT04522141|147287601|OTHER|||||||0.016||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.016
73952787|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-10.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-10.0|<0.001
73952788|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-15.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-15.0|<0.001
73872200|NCT04522141|147287601|SUPERIORITY|||||||0.363||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.363
73872201|NCT04522141|147287602|OTHER||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||> .05
73872202|NCT04522141|147287602|SUPERIORITY||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||> .05
73872203|NCT04522141|147287603|OTHER|||||||0.389||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.389
73872204|NCT04522141|147287603|SUPERIORITY|||||||0.516||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.516
73872205|NCT04522141|147287604|OTHER|||||||0.005||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.005
73872206|NCT04522141|147287604|SUPERIORITY|||||||0.555||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.555
73872207|NCT04522141|147287605|OTHER|||||||0.206||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.206
74089425|NCT02697773|147731628|SUPERIORITY||Least Square Mean Difference|-5.43|STANDARD_ERROR_OF_MEAN|4.14||0.1911|TWO_SIDED|95.0|-13.59|2.74|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.74|-13.59|0.1911
73872208|NCT04522141|147287605|SUPERIORITY|||||||0.026||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.026
73872209|NCT00555217|147287613|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.3|TWO_SIDED|95.0|0.7|1.12|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB|||1.12|0.70|0.30
73872210|NCT00555217|147287614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.1|TWO_SIDED|95.0|0.58|1.05|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB|||1.05|0.58|0.10
73872211|NCT01868477|147287615|OTHER|difference|Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|-24.0|48.16||||||||48.16|-24.0|
73872212|NCT00367835|147287630|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73872213|NCT00367835|147287631|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73872214|NCT00367835|147287632|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73872215|NCT00367835|147287633|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73872216|NCT00367835|147287634|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73872217|NCT00367835|147287635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||ANCOVA|||||||0.002
73872218|NCT00367835|147287636|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
73952789|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.8||0.001|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.001
73952790|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
73872219|NCT03228212|147287693|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|1.16|9.09|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|It was calculated that 60 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||9.09|1.16|
73952791|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
74089426|NCT02697773|147731628|SUPERIORITY||Least Square Mean Difference|-5.59|STANDARD_ERROR_OF_MEAN|4.2||0.1857|TWO_SIDED|95.0|-13.89|2.71|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.71|-13.89|0.1857
73872220|NCT03228212|147287694|NON_INFERIORITY|A non-inferiority margin of 0.05 logmar was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.00621|||TWO_SIDED|95.0|0.01|0.03|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|It was calculated that 40 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.||0.03|0.01|
73872221|NCT03228212|147287695|NON_INFERIORITY|A non-inferiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|proportion|0.992|||||TWO_SIDED|95.0|0.96|1.0|||Bayesian Methods|Bayesian Methods-Jefferys prior for binomial proportion was used to calculate 95% credible interval.||It was calculated that 70 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a the 2-week follow-up. Sample size was determined using simulations methods for repeated measures. Analysis was only performed on eyes wearing the Tesl lens.||1|0.96|
73872222|NCT03228212|147287696|NON_INFERIORITY|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|-0.0043|STANDARD_DEVIATION|0.0089|||TWO_SIDED|95.0|-0.0237|0.0129|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data|Mean difference calculated as Test - Control|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.||0.0129|-0.0237|
74089427|NCT02697773|147731628|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|4.21||0.1707|TWO_SIDED|95.0|-14.12|2.52|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.52|-14.12|0.1707
73872223|NCT03228212|147287697|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|1.8|||TWO_SIDED|95.0|3.69|10.74|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.||10.74|3.69|
73872224|NCT03228212|147287698|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|0.36|6.29|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.||6.29|0.36|
73872225|NCT01807299|147287699|OTHER||Mean Difference (Final Values)|5.0||||0.05|ONE_SIDED|5.0|||||Chi-squared, Corrected|||||||0.05
73872226|NCT01938040|147287715|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
73872227|NCT02451943|147287733|SUPERIORITY||Hazard Ratio (HR)|1.047||||0.6945|TWO_SIDED|95.0|0.841|1.303|||Log Rank|Stratified||||1.303|0.841|0.6945
73872228|NCT02451943|147287734|SUPERIORITY||Hazard Ratio (HR)|0.951||||0.7618|TWO_SIDED|95.0|0.69|1.312|||Log Rank|Stratified||||1.312|0.690|0.7618
73872229|NCT02451943|147287735|SUPERIORITY||Hazard Ratio (HR)|1.231||||0.0422|TWO_SIDED|95.0|1.009|1.502|||Log Rank|Stratified||||1.502|1.009|0.0422
73952792|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.0||0.009|TWO_SIDED|95.0|-9.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-9.0|0.009
73952793|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.0||0.003|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.003
73952794|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
73952795|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.0||0.11|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.11
73952796|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.0||0.066|TWO_SIDED|95.0|-8.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-8.0|0.066
74089428|NCT02697773|147731628|SUPERIORITY||Least Square Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|4.29||0.138|TWO_SIDED|95.0|-14.85|2.07|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.07|-14.85|0.1380
73872230|NCT02451943|147287741|SUPERIORITY||Hazard Ratio (HR)|0.616||||0.0934|TWO_SIDED|95.0|0.347|1.093|||Log Rank|Stratified||||1.093|0.347|0.0934
73872231|NCT02451943|147287742|SUPERIORITY||Hazard Ratio (HR)|1.123||||0.3347|TWO_SIDED|95.0|0.892|1.413|||Log Rank|Stratified||||1.413|0.892|0.3347
73872232|NCT01101035|147287748|NON_INFERIORITY|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.359 (75% interim) based on the Lan-DeMets-O'Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|0.99|||||ONE_SIDED|97.0||1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.||1.23||
73872233|NCT01101035|147287749|OTHER||Cox Proportional Hazard|1.09|||||TWO_SIDED|95.0|0.92|1.28|||||Time from randomization to the first occurrence of any APTC event was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function status as a stratification factor.|||1.28|0.92|
73872234|NCT01101035|147287750|OTHER||Cox Proportional Hazard|1.34|||||TWO_SIDED|95.0|1.03|1.73|||||Time from randomization to the first occurrence of cardiovascular death was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.73|1.03|
73872235|NCT01101035|147287751|OTHER||Cox Proportional Hazard|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Time from randomization to the first occurrence of non-fatal MI was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.21|0.72|
73872236|NCT01101035|147287752|OTHER||Cox Proportional Hazard|1.01|||||TWO_SIDED|95.0|0.73|1.41|||||Time from randomization to the first occurrence of non-fatal stroke was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.41|0.73|
73872237|NCT01101035|147287753|OTHER||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.59|1.26|||||Time from randomization to the first occurrence of unstable angina with urgent coronary revascularization was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.26|0.59|
73872238|NCT01101035|147287754|NON_INFERIORITY|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.014 (final analysis) based on the Lan-DeMets-O'Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|1.03|||||TWO_SIDED|97.0|0.87|1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.||1.23|0.87|
73872239|NCT01717872|147287780|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||MAC blade lifting the tongue versus Miller blade lifting the epiglottis||||>0.05
73872240|NCT01717872|147287781|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73872241|NCT01717872|147287782|SUPERIORITY_OR_OTHER||||||<|0.0004|||||||Wilcoxon (Mann-Whitney)|||||||<0.0004
73872242|NCT02214290|147287783|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
73872243|NCT02214290|147287784|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
73872244|NCT02214290|147287785|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
73952797|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
73872245|NCT01510158|147287786|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.17|0.36|||Cochran-Mantel-Haenszel|||||0.36|0.17|<0.0001
73872246|NCT01510158|147287786|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.22|0.41|||Cochran-Mantel-Haenszel|||||0.41|0.22|<0.0001
73872247|NCT01510158|147287787|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99||||0.9796|TWO_SIDED|95.0|0.61|1.61|||Negative Binomial Regression|||||1.61|0.61|0.9796
73872248|NCT01510158|147287787|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.6125|TWO_SIDED|95.0|0.54|1.43|||Negative Binomial Regression|||||1.43|0.54|0.6125
73872249|NCT01510158|147287788|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.29||||0.0183|TWO_SIDED|95.0|-0.51|-0.08|||Cochran-Mantel-Haenszel|||||-0.08|-0.51|0.0183
73872250|NCT01510158|147287788|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.5974|TWO_SIDED|95.0|-0.37|0.2|||Cochran-Mantel-Haenszel|||||0.2|-0.37|0.5974
73872251|NCT01915173|147287831|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Regression, Logistic|||All 4 arms were combined to compare the Standard Interview groups to the Expanded Interview groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.||||0.01
73872252|NCT01915173|147287831|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Regression, Logistic|||All 4 arms were combined to compare the Placebo groups to the Supplement groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.||||0.33
73872253|NCT02152761|147287833|SUPERIORITY||Treatment Group Ratio (BYM - Placebo)|1.057|||<|0.0001|TWO_SIDED|95.0|1.037|1.076|||Mixed Models Analysis||Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.|week 12||1.076|1.037|<.0001
73872254|NCT02152761|147287833|SUPERIORITY||Treatment group rratio (BYM - Placebo)|1.043|||<|0.0001|TWO_SIDED|95.0|1.024|1.064|||Mixed Models Analysis||Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.|week 12||1.064|1.024|<.0001
73872255|NCT02152761|147287834|SUPERIORITY||LS Mean of Treatment Difference|-0.071||||0.1829|TWO_SIDED|95.0|-0.175|0.034||Treatment Difference (BYM-Placebo)|Mixed Models Analysis|||week 24||0.034|-0.175|0.1829
73872256|NCT02152761|147287834|SUPERIORITY||LS Mean of Treatment Difference|0.011||||0.8365|TWO_SIDED|95.0|-0.096|0.119|||Mixed Models Analysis|||week 24||0.119|-0.096|0.8365
73872257|NCT02152761|147287835|SUPERIORITY||LS Mean of Treatment Difference|-0.371||||0.5802|TWO_SIDED|95.0|-1.311|1.053|||Mixed Models Analysis|||week 24||1.053|-1.311|0.5802
73872258|NCT02152761|147287835|SUPERIORITY||LS Mean of the Treatment Difference|0.833||||0.0913|TWO_SIDED|95.0|-0.135|1.801|||Mixed Models Analysis|||week 24||1.801|-0.135|0.0913
73872259|NCT02152761|147287836|SUPERIORITY||Falls Rate Ratio|1.08||||0.8353|TWO_SIDED|95.0|0.53|2.21|||Negative binomial regression|||||2.21|0.53|0.8353
73872260|NCT02152761|147287836|SUPERIORITY||Falls Rate Ratio|1.58||||0.2015|TWO_SIDED|95.0|0.78|3.18|||Negative binomial regression|||||3.18|0.78|0.2015
73872261|NCT02152761|147287836|SUPERIORITY||Falls Rate Ratio|1.25||||0.3999|TWO_SIDED|95.0|0.52|3.0|||Negative binomial regression|||week 24||3.00|0.52|0.3999
73872262|NCT01290757|147287861|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.082|||||ONE_SIDED|95.0|||||Mixed Models Analysis||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps||||
73872263|NCT01290757|147287861|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.33||||||90.0|119.45|133.6|||Mixed Models Analysis|||Capsugel vs Qualicaps||133.60|119.45|
73872264|NCT01290757|147287862|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.085|||||ONE_SIDED|95.0|||||Mixed Models Analysis||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps||||
73952798|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.4|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.40
73872265|NCT01290757|147287862|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.49||||||90.0|118.69|132.67|||Mixed Models Analysis|||Capsugel vs Qualicaps||132.67|118.69|
74032986|NCT00872170|147618962|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||This study had 80% power at level alpha=0.05 to detect a 60 m change in 6MWT among N=10 participants, assuming a 60 m standard deviation for 12-week change.||||0.97
74032987|NCT00872170|147618963|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.04
73872266|NCT01290757|147287863|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.74||||||90.0|118.32|131.51|||Mixed Models Analysis|||Capsugel vs Qualicaps||131.51|118.32|
73872267|NCT01290757|147287864|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.22||||||90.0|119.36|133.47|||Mixed Models Analysis|||Capsugel vs Qualicaps||133.47|119.36|
74032988|NCT00872170|147618964|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.005
74032989|NCT00872170|147618965|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.02
74032990|NCT00872170|147618966|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.05
74032991|NCT00872170|147618967|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.02
74032992|NCT00872170|147618968|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.04
74032993|NCT00872170|147618969|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.33
74032994|NCT00872170|147618970|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.18
74032995|NCT00872170|147618971|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.97
74032996|NCT00872170|147618972|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.96
74089429|NCT02697773|147731628|SUPERIORITY||Least Square Mean Difference|-3.82|STANDARD_ERROR_OF_MEAN|2.42||0.1151|TWO_SIDED|95.0|-8.58|0.94|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.94|-8.58|0.1151
73872268|NCT01290757|147287865|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.3||||||90.0|118.42|132.59|||Mixed Models Analysis|||Capsugel vs Qualicaps||132.59|118.42|
73872269|NCT01290757|147287866|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.49||||||90.0|118.11|131.21|||Mixed Models Analysis|||Capsugel vs Qualicaps||131.21|118.11|
73872270|NCT00759161|147287867|SUPERIORITY_OR_OTHER||||||<|0.001|||||||2-sided sign test|||||||< 0.001
73872271|NCT00479336|147287874|SUPERIORITY_OR_OTHER||Slope|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.3167|TWO_SIDED|95.0|-0.061|0.02|||Regression, Linear|||A linear regression model using change in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset. The null hypothesis of whether the regression coefficient is zero (analysis using t-statistics) was tested at a two-tailed significance level of 0.05, and estimated values for the slope and 95% confidence interval were calculated.||0.020|-0.061|0.3167
73872272|NCT02631551|147287886|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.||||<0.0001
73872273|NCT02631551|147287886|SUPERIORITY|||||||0.0029|||||||Mixed Models Analysis|||GSP 301 NS vs Olopatadine HCl NS comparison for rTNSS was tested at 0.05 significance level.||||0.0029
73872274|NCT02631551|147287886|SUPERIORITY|||||||0.0587|||||||Mixed Models Analysis|||GSP 301 NS vs Mometasone furoate NS comparison for rTNSS was tested at 0.05 significance level.||||0.0587
73872275|NCT02631551|147287886|SUPERIORITY|||||||0.0755|||||||Mixed Models Analysis|||Olopatadine HCl NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.||||0.0755
73872276|NCT02631551|147287886|SUPERIORITY|||||||0.0043|||||||Mixed Models Analysis|||Mometasone furoate NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.||||0.0043
73872277|NCT04112303|147287887|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate was compared to the pre-specified efficacy threshold of 78% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.||||<0.001
73980025|NCT01836523|147505321|SUPERIORITY_OR_OTHER||Treatment ratio|1.0||||0.9615|TWO_SIDED|95.0|0.96|1.04|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||1.04|0.96|0.9615
73872278|NCT05919888|147287935|SUPERIORITY|||||||0.275|||||||Chi-squared|||||||0.275
73872279|NCT05919888|147287936|SUPERIORITY|||||||0.0056|||||||Chi-squared|||||||0.0056
73872280|NCT05919888|147287937|SUPERIORITY|||||||0.286|||||||Chi-squared|||||||0.286
73872281|NCT02204072|147287941|OTHER||Hazard Ratio (HR)|0.98||||0.9549|TWO_SIDED|95.0|0.57|1.7|||Two-sided log-rank test.||Cox proportional hazard model. Hazard ratio: Comparison vs Enzalutamide|||1.70|0.57|0.9549
73872282|NCT02204072|147287944|OTHER||Hazard Ratio (HR)|1.19||||0.5425|TWO_SIDED|95.0|0.68|2.06|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzaludamide.|||2.06|0.68|0.5425
73872283|NCT02204072|147287945|OTHER||Hazard Ratio (HR)|1.16||||0.5534|TWO_SIDED|95.0|0.71|1.9|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzalutamide.|||1.90|0.71|0.5534
73872284|NCT02204072|147287946|OTHER||Hazard Ratio (HR)|0.64||||0.1514|TWO_SIDED|95.0|0.35|1.18|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzalutamide.|||1.18|0.35|0.1514
73872285|NCT02204072|147287950|OTHER||Odds Ratio (OR)|1.579||||0.6186|TWO_SIDED|95.0|0.269|12.515|||Regression, Logistic|Odds ratio, p-value and confidence interval were obtained from logistic regression model.||||12.515|0.269|0.6186
73872286|NCT02204072|147287952|OTHER||Odds Ratio (OR)|1.891||||0.192|TWO_SIDED|95.0|0.727|5.059|||Regression, Logistic||Odds ratio, p-value and confidence interval were obtained from logistic regression model.|||5.059|0.727|0.1920
73872287|NCT04209205|147287954|SUPERIORITY||Marginal difference|25.02|||<|0.0001|TWO_SIDED|95.0|17.61|32.43|||Regression, Logistic|||||32.43|17.61|<.0001
73872288|NCT04209205|147287955|SUPERIORITY||Marginal difference|30.59|||<|0.0001|TWO_SIDED|95.0|21.14|40.05|||Regression, Logistic|||||40.05|21.14|<.0001
73872289|NCT04209205|147287956|SUPERIORITY||Marginal difference|17.17|||<|0.0001|TWO_SIDED|95.0|10.48|23.85|||Regression, Logistic|||||23.85|10.48|<.0001
73872290|NCT04209205|147287957|SUPERIORITY||Marginal difference|41.39|||<|0.0001|TWO_SIDED|95.0|30.64|52.13|||Regression, Logistic|||||52.13|30.64|<.0001
73872291|NCT04209205|147287958|SUPERIORITY||Least squares mean|-1.13|STANDARD_ERROR_OF_MEAN|0.129|<|0.0001|TWO_SIDED|95.0|-1.38|0.87|||Mixed Models Analysis|||||0.87|-1.38|<.0001
74089430|NCT02697773|147731628|SUPERIORITY||Least Square Mean Difference|-3.77|STANDARD_ERROR_OF_MEAN|2.41||0.1195|TWO_SIDED|95.0|-8.51|0.98|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.98|-8.51|0.1195
73872292|NCT04209205|147287959|SUPERIORITY||Least squares mean|-0.24|STANDARD_ERROR_OF_MEAN|-0.043|<|0.0001|TWO_SIDED|95.0|-0.32|0.15|||Mixed Models Analysis|||||0.15|-0.32|<.0001
73872293|NCT04209205|147287960|SUPERIORITY||Least squares mean|4.13|STANDARD_ERROR_OF_MEAN|0.676|<|0.0001|TWO_SIDED|95.0|2.8|5.46|||Mixed Models Analysis|||||5.46|2.80|<.0001
73872294|NCT04209205|147287961|SUPERIORITY||Least squares mean|2.85|STANDARD_ERROR_OF_MEAN|0.933||0.0024|TWO_SIDED|95.0|1.01|4.68|||Mixed Models Analysis|||||4.68|1.01|0.0024
73872295|NCT04209205|147287962|SUPERIORITY||Least squares mean|-6.11|STANDARD_ERROR_OF_MEAN|1.447|<|0.0001|TWO_SIDED|95.0|-8.96|-3.26|||Mixed Models Analysis|||||-3.26|-8.96|<.0001
73872296|NCT04209205|147287963|SUPERIORITY||Marginal difference|27.49||||0.0003|TWO_SIDED|95.0|12.43|42.55|||Regression, Logistic|||||42.55|12.43|0.0003
73872297|NCT04209205|147287964|SUPERIORITY||Marginal difference|16.35||||0.0102|TWO_SIDED|95.0|3.88|28.82|||Regression, Logistic|||||28.82|3.88|0.0102
73872298|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for each serotype 1, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.96|||||TWO_SIDED|95.0|0.88|1.05||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.05|0.88|
73872299|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.75|||||TWO_SIDED|95.0|0.69|0.81||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.81|0.69|
73872300|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.26|0.96|
73980026|NCT01836523|147505322|SUPERIORITY_OR_OTHER||Rate ratio|1.31||||0.0081|TWO_SIDED|95.0|1.07|1.59|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.59|1.07|0.0081
73980027|NCT01836523|147505322|SUPERIORITY_OR_OTHER||Rate ratio|1.27||||0.0219|TWO_SIDED|95.0|1.03|1.55|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.55|1.03|0.0219
73980028|NCT01836523|147505322|SUPERIORITY_OR_OTHER||Rate ratio|1.17||||0.1079|TWO_SIDED|95.0|0.97|1.43|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.43|0.97|0.1079
74089431|NCT02697773|147731639|SUPERIORITY||Odds Ratio (OR)|0.48||||0.1444|TWO_SIDED|95.0|0.18|1.29|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.29|0.18|0.1444
73980029|NCT00321971|147505323|SUPERIORITY||Mean Difference (Final Values)|0.421|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|0.208|0.657|||Mixed Models Analysis|Intention-to-treat model|The CES-D data were log-transformed for analysis|Hypothesis: The experimental intervention group will endorse lower mean levels of depressive symptoms during follow-up than the study group receiving the comparison intervention.||0.657|0.208|<.05
73980030|NCT01393600|147505334|OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.3||0.588|TWO_SIDED|95.0|-3.3|1.9|||ANOVA|||||1.9|-3.3|0.5880
73872301|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|1.41|||||TWO_SIDED|95.0|1.18|1.69||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.69|1.18|
73872302|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|1.09|||||TWO_SIDED|95.0|0.99|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.20|0.99|
73980031|NCT01393600|147505334|OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.4184|TWO_SIDED|95.0|-3.8|1.6|||ANOVA|||||1.6|-3.8|0.4184
73980032|NCT01393600|147505336|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.6761|TWO_SIDED|95.0|-2.4|1.6|||ANOVA|||||1.6|-2.4|0.6761
73980033|NCT01393600|147505336|OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.1||0.0015|TWO_SIDED|95.0|-6.6|-1.8|||ANOVA|||||-1.8|-6.6|0.0015
73980034|NCT01102426|147505345|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.0054|TWO_SIDED|95.0|0.447|0.885||Cox regression: HR p=0.0062|Log Rank|||||0.885|0.447|=0.0054
73980035|NCT01102426|147505346|SUPERIORITY|||||||0.0618|||||||Normal approximation|||||||0.0618
73980036|NCT01102426|147505347|SUPERIORITY||Hazard Ratio (HR)|0.512|||<|0.0001|TWO_SIDED|95.0|0.382|0.686||Cox regression HR: p\<0.0001|Log Rank|||||0.686|0.382|< 0.0001
73980037|NCT01102426|147505348|SUPERIORITY|||||||0.0002|||||||Normal approximation|||||||0.0002
73980038|NCT01102426|147505349|SUPERIORITY||Hazard Ratio (HR)|0.797|||=|0.1261|TWO_SIDED|95.0|0.596|1.067||Cox regression HR: p=0.1273|Log Rank|||Pre-specified||1.067|0.596|=0.1261
73980039|NCT01102426|147505350|SUPERIORITY|||||||0.3625|||||||Normal approximation|||||||0.3625
73980040|NCT01102426|147505351|SUPERIORITY|||||||0.1037|||||||Normal approximation|||||||0.1037
73872303|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.18||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.18|0.98|
73872304|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.07|0.81|
73872305|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.04|0.83|
73872306|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|0.84|||||TWO_SIDED|95.0|0.76|0.92||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.92|0.76|
73952799|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.24|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.24
73952800|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
73952801|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.1||0.17|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.17
73952802|NCT02886728|147439415|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.1||0.008|TWO_SIDED|95.0|-10.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-10.0|0.008
73952803|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-12.0|<0.001
73952804|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-9.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-9.0|<0.001
73952805|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
73952806|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|-13.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-13.0|<0.001
73980041|NCT01102426|147505352|SUPERIORITY||Hazard Ratio (HR)|0.384|||=|0.1015|TWO_SIDED|95.0|0.113|1.303||Cox regression HR: 0.1247|Log Rank|||||1.303|0.113|=0.1015
73980042|NCT01102426|147505354|SUPERIORITY||Hazard Ratio (HR)|0.043|||=|0.0001|TWO_SIDED|95.0|0.004|0.479||Cox regression HR: 0.0105|Log Rank|||Pre-specified||0.479|0.004|=0.0001
73872307|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.15|0.91|
73872308|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.89|||||TWO_SIDED|95.0|0.82|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.97|0.82|
73980043|NCT01102426|147505357|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73980044|NCT01102426|147505358|SUPERIORITY|||||||0.0085|||||||Fisher Exact|||||||0.0085
74032997|NCT01064648|147618988|OTHER||Hazard Ratio (HR)|0.71||||0.06|TWO_SIDED|80.0|0.54|0.95||1-sided p-value|Log Rank|Stratified log rank test by performance status and histology type.||||0.95|0.54|0.06
74032998|NCT01064648|147618989|OTHER||Hazard Ratio (HR)|0.88||||0.28|TWO_SIDED|80.0|0.65|1.17||1-sided p-value|Log Rank|Stratified log-rank test by performance status and histology.||||1.17|0.65|0.28
74032999|NCT01064648|147618990|OTHER||Odds Ratio (OR)|1.85||||0.15|TWO_SIDED|95.0|0.59|5.83||1-sided p-value|Chi-squared|Stratified Chi-square by performance status and histology.||||5.83|0.59|0.15
73872309|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.73|||||TWO_SIDED|95.0|0.67|0.8||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2||0.80|0.67|
73980045|NCT01102426|147505360|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73980046|NCT01102426|147505361|SUPERIORITY|||||||0.0029|||||||Fisher Exact|||||||0.0029
74033000|NCT01064648|147618991|OTHER||Odds Ratio (OR)|0.45||||0.09|TWO_SIDED|95.0|0.14|1.49||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology||||1.49|0.14|0.09
74033001|NCT01064648|147618992|OTHER||Odds Ratio (OR)|4.3||||0.006|TWO_SIDED|95.0|1.4|13.3||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology.||||13.3|1.4|0.006
73980047|NCT01702259|147505362|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
73980048|NCT01702259|147505363|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73980049|NCT01702259|147505364|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
73980050|NCT01702259|147505365|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
73980051|NCT03136861|147505368|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0264|TWO_SIDED|95.0|1.08|3.33|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||Average Spinal Pain Score \<4 at Week 8||3.33|1.08|0.0264
73980052|NCT03136861|147505368|SUPERIORITY||Odds Ratio (OR)|1.72||||0.072|TWO_SIDED|95.0|0.95|3.1|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Total Spinal Pain Score \<4 at Week 8||3.10|0.95|0.0720
73980053|NCT03136861|147505368|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0043|TWO_SIDED|95.0|1.31|4.31|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Nocturnal Spinal Pain Score||4.31|1.31|0.0043
73980054|NCT03136861|147505369|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0466|TWO_SIDED|95.0|1.01|3.04|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||BASDAI Score \<4 at Week 8||3.04|1.01|0.0466
74033002|NCT01064648|147618993|OTHER||Odds Ratio (OR)|0.59||||0.19|TWO_SIDED|95.0|0.18|1.94||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology||||1.94|0.18|0.19
74033003|NCT05281523|147619000|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group.|Difference in Least Square Means|-0.6||||0.004|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.2|-1.0|0.004
74033004|NCT05281523|147619001|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group.|Difference in Least Square Means|-0.25||||0.025|TWO_SIDED|95.0|-0.46|-0.03|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.03|-0.46|0.025
74033005|NCT05281523|147619002|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group, subgroup by treatment group and subgroup by visit by treatment group.|Difference in Least Square Means|-0.18||||0.125|TWO_SIDED|95.0|-0.4|0.05|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||0.05|-0.40|0.125
74033006|NCT05281523|147619003|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group, subgroup by treatment group and subgroup by visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.26||||0.007|TWO_SIDED|95.0|-0.45|-0.07|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||-0.07|-0.45|0.007
73872310|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.04|||||TWO_SIDED|95.0|0.91|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2||1.20|0.91|
73872311|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.87|||||TWO_SIDED|95.0|0.74|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.04|0.74|
73872312|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.75|||||TWO_SIDED|95.0|0.68|0.83||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.83|0.68|
73872313|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.97|0.80|
73872314|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.09|0.83|
73872315|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.98|0.79|
73872316|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.08|||||TWO_SIDED|95.0|0.97|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.20|0.97|
73872317|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 24F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.03|||||TWO_SIDED|95.0|0.92|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.15|0.92|
73872318|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.93|||||TWO_SIDED|95.0|0.85|1.01||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.01|0.85|
73952807|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
73980055|NCT01328756|147505391|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to LOTA value was assessed for differences from zero using a 2-sided, 1 sample t-test at a 0.05 significance level.||||< 0.001
73980056|NCT04492475|147505397|SUPERIORITY||Cox Proportional Hazard|0.99||||0.88|TWO_SIDED|95.0|0.87|1.13|||Log Rank|||||1.13|0.87|0.880
73952808|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
73952809|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
73980057|NCT04492475|147505414|SUPERIORITY||Risk Difference (RD)|7.2|||||TWO_SIDED|95.0|0.9|13.4||||||||13.4|0.9|
73980058|NCT04492475|147505414|SUPERIORITY||Risk Difference (RD)|23.6|||||TWO_SIDED|95.0|0.0|43.9||||||||43.9|0.0|
73872319|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.98|||||TWO_SIDED|95.0|0.9|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.07|0.90|
73872320|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.09|0.82|
73872321|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.74|0.52|
73872322|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.69|||||TWO_SIDED|95.0|0.62|0.76||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.76|0.62|
73872323|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.9||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.90|0.74|
73872324|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.17||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.17|0.89|
73872325|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.06||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.06|0.85|
73872326|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.29|||||TWO_SIDED|95.0|1.16|1.44||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.44|1.16|
73872327|NCT03197376|147287965|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.13|0.89|
73872328|NCT03197376|147287966|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10%, for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 1|0.7|||||TWO_SIDED|97.5|0.0|1.9||||||||1.9|-0.0|
73872329|NCT03197376|147287966|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 5|2.8|||||TWO_SIDED|97.5|1.2|5.0||||||||5.0|1.2|
73980059|NCT04492475|147505415|SUPERIORITY||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-3.2|6.0||||||||6.0|-3.2|
73872330|NCT03197376|147287966|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6A|5.2|||||TWO_SIDED|97.5|1.1|9.5||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||9.5|1.1|
73872331|NCT03197376|147287966|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6B|2.0|||||TWO_SIDED|97.5|-2.2|6.4||||||||6.4|-2.2|
73872332|NCT03197376|147287966|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 7F|1.0|||||TWO_SIDED|97.5|-0.1|2.7||||||||2.7|-0.1|
73980060|NCT04492475|147505415|SUPERIORITY||Risk Difference (RD)|35.8|||||TWO_SIDED|95.0|12.3|54.2||||||||54.2|12.3|
73980061|NCT04492475|147505439|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.9|1.19||||||||1.19|0.90|
73980062|NCT04492475|147505439|SUPERIORITY||Cox Proportional Hazard|0.37|||||TWO_SIDED|95.0|0.21|0.66||||||||0.66|0.21|
73872333|NCT03197376|147287966|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 9V|0.1|||||TWO_SIDED|97.5|-1.9|2.5||||||||2.5|-1.9|
73872334|NCT03197376|147287966|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 14|-0.3|||||TWO_SIDED|97.5|-1.4|1.0||||||||1.0|-1.4|
73872335|NCT03197376|147287966|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19A|18.7|||||TWO_SIDED|97.5|15.1|22.5||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||22.5|15.1|
73872336|NCT03197376|147287966|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19F|-0.8|||||TWO_SIDED|97.5|-1.9|0.5||||||||0.5|-1.9|
73872337|NCT03197376|147287966|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 23F|17.2|||||TWO_SIDED|97.5|13.6|21.1||||||||21.1|13.6|
73872338|NCT03197376|147287967|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 1 GMC Ratio|2.15|||||TWO_SIDED|97.5|2.0|2.32||||||||2.32|2.00|
73872339|NCT03197376|147287967|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 5 GMC Ratio|1.37|||||TWO_SIDED|97.5|1.28|1.47||||||||1.47|1.28|
73980063|NCT04492475|147505440|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
73980064|NCT04492475|147505440|SUPERIORITY||Cox Proportional Hazard|0.44|||||TWO_SIDED|95.0|0.24|0.82||||||||0.82|0.24|
73980065|NCT04492475|147505441|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.93|1.26||||||||1.26|0.93|
73980066|NCT04492475|147505441|SUPERIORITY||Cox Proportional Hazard|0.39|||||TWO_SIDED|95.0|0.21|0.72||||||||0.72|0.21|
73980067|NCT04492475|147505442|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.9|1.19||||||||1.19|0.90|
73980068|NCT04492475|147505443|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.59|1.45||||||This analysis is for Asian participants.||1.45|0.59|
73980069|NCT04492475|147505443|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.66|1.27||||||This analysis is for Black and African American participants.||1.27|0.66|
73980070|NCT04492475|147505443|SUPERIORITY||Cox Proportional Hazard|1.02|||||TWO_SIDED|95.0|0.86|1.21||||||This analysis is for White participants.||1.21|0.86|
73980071|NCT04492475|147505443|SUPERIORITY||Cox Proportional Hazard|0.84|||||TWO_SIDED|95.0|0.59|1.19||||||This analysis is for Race of Other participants||1.19|0.59|
73980072|NCT04492475|147505444|SUPERIORITY||Cox Proportional Hazard|1.02|||||TWO_SIDED|95.0|0.86|1.19||||||This analysis is for Not Hispanic or Latino participants.||1.19|0.86|
73980073|NCT04492475|147505444|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.65|1.05||||||This analysis is for Hispanic or Latino participants.||1.05|0.65|
73980074|NCT04492475|147505445|SUPERIORITY||Cox Proportional Hazard|0.93|||||TWO_SIDED|95.0|0.78|1.1||||||This analysis is for Male participants.||1.10|0.78|
73872340|NCT03197376|147287967|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6A GMC Ratio|0.89|||||TWO_SIDED|97.5|0.78|1.01||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||1.01|0.78|
73872341|NCT03197376|147287967|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6B GMC Ratio|1.07|||||TWO_SIDED|97.5|0.93|1.24||||||||1.24|0.93|
73872342|NCT03197376|147287967|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 7F GMC Ratio|1.3|||||TWO_SIDED|97.5|1.19|1.41||||||||1.41|1.19|
73872343|NCT03197376|147287967|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 9V GMC Ratio|0.92|||||TWO_SIDED|97.5|0.85|1.0||||||||1.00|0.85|
73980075|NCT04492475|147505445|SUPERIORITY||Cox Proportional Hazard|1.05|||||TWO_SIDED|95.0|0.86|1.29||||||This analysis is for Female participants.||1.29|0.86|
73980076|NCT01860079|147505456|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared, Corrected|||Categorical data were analyzed with χ2.Comparisons were also analyzed by χ2 between the early discharge and standard treatment arm for the primary outcomes.||||<0.05
73980077|NCT01323790|147505463|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.188||||0.202|TWO_SIDED|95.0|0.911|1.548|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.548|0.911|0.202
73980078|NCT01323790|147505463|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.348||||0.021|TWO_SIDED|95.0|1.045|1.739|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.739|1.045|0.021
73980079|NCT01323790|147505464|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.35||||0.074|TWO_SIDED|95.0|0.967|1.884||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||1.884|0.967|0.074
73980080|NCT01323790|147505464|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.489||||0.014|TWO_SIDED|95.0|1.078|2.058||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.058|1.078|0.014
73872344|NCT03197376|147287967|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 14 GMC Ratio|1.23|||||TWO_SIDED|97.5|1.1|1.37||||||||1.37|1.10|
73872345|NCT03197376|147287967|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19A GMC Ratio|1.45|||||TWO_SIDED|97.5|1.3|1.63||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||1.63|1.30|
73872346|NCT03197376|147287967|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19F GMC Ratio|0.73|||||TWO_SIDED|97.5|0.67|0.8||||||||0.80|0.67|
73872347|NCT03197376|147287967|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 23F GMC Ratio|1.81|||||TWO_SIDED|97.5|1.63|2.01||||||||2.01|1.63|
73872348|NCT03197376|147287968|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for diphtheria|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
73872349|NCT03197376|147287968|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Tetanus|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
73872350|NCT03197376|147287968|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hepatitis B|0.4|||||TWO_SIDED|95.0|-0.4|2.5||||||||2.5|-0.4|
73872351|NCT03197376|147287968|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hib|-0.9|||||TWO_SIDED|95.0|-2.5|1.2||||||||1.2|-2.5|
73872352|NCT03197376|147287968|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 1|-0.2|||||TWO_SIDED|95.0|-1.3|1.5||||||||1.5|-1.3|
73872353|NCT03197376|147287968|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 2|2.8|||||TWO_SIDED|95.0|-3.2|9.3||||||||9.3|-3.2|
73872354|NCT03197376|147287968|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 3|-0.9|||||TWO_SIDED|95.0|-3.0|1.8||||||||1.8|-3.0|
73872355|NCT03197376|147287968|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Rotavirus|0.2|||||TWO_SIDED|95.0|-7.1|7.1||||||||7.1|-7.1|
73872356|NCT03197376|147287969|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-pertussis toxoid|0.82|||||TWO_SIDED|95.0|0.62|1.09||||||||1.09|0.62|
73872357|NCT03197376|147287970|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-fimbriae 2/3|0.98|||||TWO_SIDED|95.0|0.77|1.25||||||||1.25|0.77|
73872358|NCT03197376|147287977|SUPERIORITY|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 6A|73.3|||||TWO_SIDED|97.5|69.8|76.3||||||||76.3|69.8|
73872359|NCT03197376|147287977|SUPERIORITY|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 19A|54.7|||||TWO_SIDED|97.5|50.3|58.9||||||||58.9|50.3|
73952810|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-9.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-9.0|<0.001
73952811|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.6||0.001|TWO_SIDED|95.0|-8.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-8.0|0.001
73952812|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
73872360|NCT03197376|147287978|SUPERIORITY|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 6A GMC Ratio|8.51|||||TWO_SIDED|97.5|7.68|9.43||||||||9.43|7.68|
73872361|NCT03197376|147287978|SUPERIORITY|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 19A GMC Ratio|5.64|||||TWO_SIDED|97.5|5.14|6.18||||||||6.18|5.14|
73872362|NCT03197376|147287979|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 1|17.2|||||TWO_SIDED|95.0|11.0|23.6||||||||23.6|11.0|
73872363|NCT03197376|147287979|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 5|2.8|||||TWO_SIDED|95.0|0.0|6.2||||||||6.2|-0.0|
74039488|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.42||0.0004|TWO_SIDED|95.0|-2.29|-0.66|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.66|-2.29|0.0004
73872364|NCT03197376|147287979|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6A|82.2|||||TWO_SIDED|95.0|76.7|86.6||||||||86.6|76.7|
73872365|NCT03197376|147287979|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6B|9.4|||||TWO_SIDED|95.0|4.5|14.6||||||||14.6|4.5|
73872366|NCT03197376|147287979|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 7F|0.4|||||TWO_SIDED|95.0|-1.1|2.2||||||||2.2|-1.1|
73872367|NCT03197376|147287979|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 9V|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
73872368|NCT03197376|147287979|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type14|-0.8|||||TWO_SIDED|95.0|-4.0|2.2||||||||2.2|-4.0|
73952813|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.5||0.007|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.007
73952814|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.5||0.046|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.046
73952815|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|-6.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-6.0|0.002
73952816|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.4||0.44|TWO_SIDED|95.0|-4.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-4.0|0.44
73952817|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.4||0.21|TWO_SIDED|95.0|-5.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-5.0|0.21
73952818|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
73952819|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.029|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.029
73952820|NCT02886728|147439416|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|95.0|-6.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-6.0|0.010
73872369|NCT03197376|147287979|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19A|53.3|||||TWO_SIDED|95.0|46.0|60.1||||||||60.1|46.0|
73872370|NCT03197376|147287979|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19F|-1.6|||||TWO_SIDED|95.0|-4.9|1.2||||||||1.2|-4.9|
73872371|NCT03197376|147287979|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 23F|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
73872372|NCT03197376|147287980|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 1|3.09|||||TWO_SIDED|95.0|2.4|3.98||||||||3.98|2.40|
73872373|NCT03197376|147287980|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 5|1.39|||||TWO_SIDED|95.0|1.12|1.72||||||||1.72|1.12|
73872374|NCT03197376|147287980|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6A|186.0|||||TWO_SIDED|95.0|144.0|241.0||||||||241|144|
73872375|NCT03197376|147287980|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6B|1.95|||||TWO_SIDED|95.0|1.42|2.69||||||||2.69|1.42|
73980081|NCT01323790|147505466|SUPERIORITY_OR_OTHER||LS mean difference|0.39||||0.01|TWO_SIDED|95.0|0.09|0.69|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.69|0.09|0.010
73872376|NCT03197376|147287980|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 7F|1.16|||||TWO_SIDED|95.0|0.96|1.39||||||||1.39|0.96|
73872377|NCT03197376|147287980|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 9V|0.38|||||TWO_SIDED|95.0|0.29|0.49||||||||0.49|0.29|
73872378|NCT03197376|147287980|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 14|0.92|||||TWO_SIDED|95.0|0.67|1.27||||||||1.27|0.67|
73872379|NCT03197376|147287980|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19A|13.4|||||TWO_SIDED|95.0|10.2|17.7||||||||17.7|10.2|
73872380|NCT03197376|147287980|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19F|0.66|||||TWO_SIDED|95.0|0.54|0.81||||||||0.81|0.54|
73872381|NCT03197376|147287980|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 23F|3.03|||||TWO_SIDED|95.0|2.25|4.09||||||||4.09|2.25|
73952821|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
73872382|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.41|||||TWO_SIDED|95.0|1.31|1.52||||||||1.52|1.31|
73872383|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.88|||||TWO_SIDED|95.0|0.81|0.95||||||||0.95|0.81|
73872384|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|4.46|||||TWO_SIDED|95.0|4.01|4.96||||||||4.96|4.01|
73872385|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|6.43|||||TWO_SIDED|95.0|5.7|7.26||||||||7.26|5.70|
73872386|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|2.04|||||TWO_SIDED|95.0|1.89|2.19||||||||2.19|1.89|
73872387|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.39|||||TWO_SIDED|95.0|1.29|1.5||||||||1.50|1.29|
73872388|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.35|||||TWO_SIDED|95.0|1.21|1.51||||||||1.51|1.21|
73872389|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|2.64|||||TWO_SIDED|95.0|2.4|2.91||||||||2.91|2.40|
73872390|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.49|||||TWO_SIDED|95.0|1.36|1.63||||||||1.63|1.36|
73872391|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.5|||||TWO_SIDED|95.0|2.29|2.72||||||||2.72|2.29|
73872392|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.17|||||TWO_SIDED|95.0|1.06|1.28||||||||1.28|1.06|
73872393|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.67|||||TWO_SIDED|95.0|0.61|0.74||||||||0.74|0.61|
73872394|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|3.49|||||TWO_SIDED|95.0|2.97|4.11||||||||4.11|2.97|
73872395|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|3.85|||||TWO_SIDED|95.0|3.23|4.59||||||||4.59|3.23|
73872396|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|1.63|||||TWO_SIDED|95.0|1.47|1.82||||||||1.82|1.47|
73872397|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.46|||||TWO_SIDED|95.0|1.31|1.62||||||||1.62|1.31|
74089432|NCT02697773|147731639|SUPERIORITY||Odds Ratio (OR)|0.29||||0.0335|TWO_SIDED|95.0|0.09|0.91|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.09|0.0335
73872398|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.21|||||TWO_SIDED|95.0|1.03|1.42||||||||1.42|1.03|
73872399|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|3.6|||||TWO_SIDED|95.0|2.99|4.33||||||||4.33|2.99|
73872400|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.55|||||TWO_SIDED|95.0|1.38|1.75||||||||1.75|1.38|
73872401|NCT03197376|147287981|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.29|||||TWO_SIDED|95.0|1.98|2.65||||||||2.65|1.98|
73952822|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
73872402|NCT03197376|147287982|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 1 GMC Ratio|2.34|||||TWO_SIDED|95.0|2.02|2.71||||||||2.71|2.02|
73872403|NCT03197376|147287982|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 5 GMC Ratio|1.57|||||TWO_SIDED|95.0|1.38|1.79||||||||1.79|1.38|
73872404|NCT03197376|147287982|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6A GMC Ratio|11.6|||||TWO_SIDED|95.0|9.67|14.0||||||||14.0|9.67|
73872405|NCT03197376|147287982|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6B GMC Ratio|1.89|||||TWO_SIDED|95.0|1.65|2.15||||||||2.15|1.65|
73872406|NCT03197376|147287982|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 7F GMC Ratio|1.57|||||TWO_SIDED|95.0|1.37|1.8||||||||1.80|1.37|
73872407|NCT03197376|147287982|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 9V GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|0.99||||||||0.99|0.76|
74089433|NCT02697773|147731640|SUPERIORITY|||||||0.0809||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0809
74089434|NCT02697773|147731640|SUPERIORITY|||||||0.0239||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0239
73872408|NCT03197376|147287982|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 14 GMC Ratio|1.48|||||TWO_SIDED|95.0|1.21|1.82||||||||1.82|1.21|
73872409|NCT03197376|147287982|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19A GMC Ratio|4.22|||||TWO_SIDED|95.0|3.52|5.06||||||||5.06|3.52|
73872410|NCT03197376|147287982|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19F GMC Ratio|0.63|||||TWO_SIDED|95.0|0.55|0.73||||||||0.73|0.55|
73872411|NCT03197376|147287982|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 23F GMC Ratio|1.91|||||TWO_SIDED|95.0|1.63|2.24||||||||2.24|1.63|
73872412|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|3.47|||||TWO_SIDED|95.0|2.72|4.44||||||||4.44|2.72|
73980082|NCT01323790|147505466|SUPERIORITY_OR_OTHER||Ls mean difference|0.68|||<|0.001|TWO_SIDED|95.0|0.37|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.98|0.37|<0.001
73980083|NCT01323790|147505467|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.005|TWO_SIDED|95.0|-0.32|-0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.06|-0.32|0.005
73872413|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|2.54|||||TWO_SIDED|95.0|2.06|3.13||||||||3.13|2.06|
73980084|NCT01323790|147505467|SUPERIORITY_OR_OTHER||LS mean difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.45|-0.18|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.18|-0.45|<0.001
73980085|NCT01323790|147505468|SUPERIORITY_OR_OTHER||LS mean difference|0.28||||0.001|TWO_SIDED|95.0|0.12|0.45|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.45|0.12|0.001
73980086|NCT01323790|147505468|SUPERIORITY_OR_OTHER||LS mean difference|0.45|||<|0.001|TWO_SIDED|95.0|0.29|0.62|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.62|0.29|<0.001
73980087|NCT01323790|147505469|SUPERIORITY_OR_OTHER||LS mean difference|6.72||||0.002|TWO_SIDED|95.0|2.37|11.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||11.06|2.37|0.002
73980088|NCT01323790|147505469|SUPERIORITY_OR_OTHER||LS mean difference|10.43|||<|0.001|TWO_SIDED|95.0|6.03|14.84|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||14.84|6.03|<0.001
73980089|NCT01323790|147505470|SUPERIORITY_OR_OTHER||LS mean difference|0.52||||0.028|TWO_SIDED|95.0|0.06|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.98|0.06|0.028
73872414|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|2.5|||||TWO_SIDED|95.0|1.83|3.42||||||||3.42|1.83|
73872415|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.76|||||TWO_SIDED|95.0|2.48|5.69||||||||5.69|2.48|
73872416|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|3.89|||||TWO_SIDED|95.0|2.92|5.18||||||||5.18|2.92|
73872417|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|6.85|||||TWO_SIDED|95.0|4.45|10.52||||||||10.52|4.45|
73980090|NCT01323790|147505470|SUPERIORITY_OR_OTHER||LS mean difference|1.04|||<|0.001|TWO_SIDED|95.0|0.58|1.51|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||1.51|0.58|<0.001
73980091|NCT01323790|147505472|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.08|TWO_SIDED|95.0|-0.26|0.01||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.26|0.080
73872418|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|2.45|||||TWO_SIDED|95.0|1.64|3.65||||||||3.65|1.64|
74033007|NCT05281523|147619004|OTHER|Analysis performed using an analysis of covariance model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region and previous surgery for nasal polyps. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level|Difference in Least Square Means|-3.2|||<|0.001|TWO_SIDED|95.0|-4.4|-2.0|||ANCOVA|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-2.0|-4.4|<0.001
74033008|NCT05281523|147619005|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-9.9||||0.015|TWO_SIDED|95.0|-17.9|-2.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-2.0|-17.9|0.015
74033009|NCT05281523|147619006|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.24||||0.016|TWO_SIDED|95.0|-0.43|-0.04|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 21 to Week 24 in participants with a diagnosis of CRSwNP||-0.04|-0.43|0.016
73872419|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|3.64|||||TWO_SIDED|95.0|2.47|5.36||||||||5.36|2.47|
73872420|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|2.38|||||TWO_SIDED|95.0|1.8|3.14||||||||3.14|1.80|
73980092|NCT01323790|147505472|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.011|TWO_SIDED|95.0|-0.32|-0.04||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.04|-0.32|0.011
73980093|NCT01323790|147505472|SUPERIORITY_OR_OTHER||Slope|0.05||||0.552|TWO_SIDED|95.0|-0.11|0.2||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.20|-0.11|0.552
73980094|NCT01323790|147505472|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.236|TWO_SIDED|95.0|-0.06|0.25||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.25|-0.06|0.236
74089435|NCT02697773|147731641|SUPERIORITY||Odds Ratio (OR)|0.7||||0.0761|TWO_SIDED|95.0|0.48|1.04|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.04|0.48|0.0761
74089436|NCT02697773|147731641|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0312|TWO_SIDED|95.0|0.44|0.96|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.96|0.44|0.0312
74089437|NCT02697773|147731641|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0262|TWO_SIDED|95.0|0.45|0.95|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.95|0.45|0.0262
73872421|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|4.97|||||TWO_SIDED|95.0|3.49|7.06||||||||7.06|3.49|
73980095|NCT01323790|147505472|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.095|TWO_SIDED|95.0|-0.24|0.02||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.02|-0.24|0.095
74089438|NCT02697773|147731641|SUPERIORITY||Odds Ratio (OR)|0.54||||0.0013|TWO_SIDED|95.0|0.37|0.79|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.79|0.37|0.0013
73872422|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|6.29|||||TWO_SIDED|95.0|4.97|7.96||||||||7.96|4.97|
73872423|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|3.19|||||TWO_SIDED|95.0|2.56|3.98||||||||3.98|2.56|
74089439|NCT02697773|147731641|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6706|TWO_SIDED|95.0|0.64|1.33|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.33|0.64|0.6706
73872424|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|6.21|||||TWO_SIDED|95.0|3.55|10.84||||||||10.84|3.55|
73872425|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.25|||||TWO_SIDED|95.0|2.25|4.7||||||||4.70|2.25|
73872426|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|2.81|||||TWO_SIDED|95.0|2.13|3.69||||||||3.69|2.13|
73872427|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|2.95|||||TWO_SIDED|95.0|2.15|4.04||||||||4.04|2.15|
73980096|NCT01323790|147505472|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.37|-0.1||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.10|-0.37|<0.001
73980097|NCT01323790|147505472|SUPERIORITY_OR_OTHER||LS mean difference|-0.27||||0.002|TWO_SIDED|95.0|-0.44|-0.1||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.10|-0.44|0.002
73980098|NCT01323790|147505472|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|||<|0.001|TWO_SIDED|95.0|-0.56|-0.21||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.21|-0.56|<0.001
73980099|NCT01323790|147505473|SUPERIORITY_OR_OTHER||LS mean difference|-0.31||||0.011|TWO_SIDED|95.0|-0.54|-0.07|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.07|-0.54|0.011
74089440|NCT02697773|147731641|SUPERIORITY||Odds Ratio (OR)|0.99||||0.972|TWO_SIDED|95.0|0.69|1.43|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.43|0.69|0.9720
73872428|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|1.62|||||TWO_SIDED|95.0|1.06|2.46||||||||2.46|1.06|
73872429|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|5.98|||||TWO_SIDED|95.0|3.88|9.21||||||||9.21|3.88|
73872430|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|1.97|||||TWO_SIDED|95.0|1.45|2.68||||||||2.68|1.45|
73872431|NCT03197376|147287983|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|5.73|||||TWO_SIDED|95.0|3.8|8.63||||||||8.63|3.80|
73872432|NCT03197376|147287984|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 1|1.84|||||TWO_SIDED|95.0|1.25|2.72||||||||2.72|1.25|
73872433|NCT03197376|147287984|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 5|1.14|||||TWO_SIDED|95.0|0.79|1.64||||||||1.64|0.79|
73872434|NCT03197376|147287984|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6A|68.1|||||TWO_SIDED|95.0|37.07|125.09||||||||125.09|37.07|
73872435|NCT03197376|147287984|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6B|1.75|||||TWO_SIDED|95.0|1.25|2.46||||||||2.46|1.25|
73980100|NCT01323790|147505473|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.73|-0.25|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.25|-0.73|<0.001
73980101|NCT00046475|147505492|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||<0.001
73980102|NCT00046475|147505493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||0.011
74089441|NCT02697773|147731641|SUPERIORITY||Odds Ratio (OR)|0.89||||0.5311|TWO_SIDED|95.0|0.61|1.29|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.29|0.61|0.5311
73872436|NCT03197376|147287984|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 7F|1.73|||||TWO_SIDED|95.0|1.28|2.34||||||||2.34|1.28|
73872437|NCT03197376|147287984|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 9V|0.93|||||TWO_SIDED|95.0|0.65|1.32||||||||1.32|0.65|
73872438|NCT03197376|147287984|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 14|2.21|||||TWO_SIDED|95.0|1.38|3.51||||||||3.51|1.38|
73872439|NCT03197376|147287984|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19A|12.54|||||TWO_SIDED|95.0|7.36|21.37||||||||21.37|7.36|
73872440|NCT03197376|147287984|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19F|1.01|||||TWO_SIDED|95.0|0.7|1.46||||||||1.46|0.70|
73872441|NCT03197376|147287984|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 23F|3.14|||||TWO_SIDED|95.0|2.21|4.45||||||||4.45|2.21|
73980103|NCT00046475|147505494|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2||||<0.001
73872442|NCT03197376|147287985|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for measles|1.7|||||TWO_SIDED|95.0|-3.3|7.4||||||||7.4|-3.3|
73872443|NCT03197376|147287985|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for rubella|1.0|||||TWO_SIDED|95.0|-0.9|4.0||||||||4.0|-0.9|
73980104|NCT00046475|147505494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3||||0.002
73872444|NCT03197376|147287985|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for yellow fever|2.4|||||TWO_SIDED|95.0|0.2|5.9||||||||5.9|0.2|
73872445|NCT03197376|147287986|OTHER|Treatment group difference in proportions|Absolute Difference for Type 1|16.2|||||TWO_SIDED|95.0|8.0|23.7||||||||23.7|8.0|
73872446|NCT03197376|147287986|OTHER|Treatment group difference in proportions|Absolute Difference for Type 5|7.2|||||TWO_SIDED|95.0|-1.4|15.8||||||||15.8|-1.4|
73872447|NCT03197376|147287986|OTHER|Treatment group difference in proportions|Absolute Difference for Type 6A|30.0|||||TWO_SIDED|95.0|21.8|38.1||||||||38.1|21.8|
73872448|NCT03197376|147287986|OTHER|Treatment group difference in proportions|Absolute Difference for Type 6B|16.5|||||TWO_SIDED|95.0|10.1|23.6||||||||23.6|10.1|
73872449|NCT03197376|147287986|OTHER|Treatment group difference in proportions|Absolute Difference for Type 7F|16.4|||||TWO_SIDED|95.0|8.4|24.5||||||||24.5|8.4|
73872450|NCT03197376|147287986|OTHER|Treatment group difference in proportions|Absolute Difference for Type 9V|-0.2|||||TWO_SIDED|95.0|-8.8|8.5||||||||8.5|-8.8|
73872451|NCT03197376|147287986|OTHER|Treatment group difference in proportions|Absolute Difference for Type 14|14.7|||||TWO_SIDED|95.0|7.5|22.3||||||||22.3|7.5|
73872452|NCT03197376|147287986|OTHER|Treatment group difference in proportions|Absolute Difference for Type 19A|14.7|||||TWO_SIDED|95.0|7.3|22.5||||||||22.5|7.3|
73872453|NCT03197376|147287986|OTHER|Treatment group difference in proportions|Absolute Difference for Type 19F|-13.7|||||TWO_SIDED|95.0|-19.0|-8.0||||||||-8.0|-19.0|
73872454|NCT03197376|147287986|OTHER|Treatment group difference in proportions|Absolute Difference for Type 23F|16.9|||||TWO_SIDED|95.0|8.2|25.4||||||||25.4|8.2|
73872455|NCT03197376|147287987|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 1 GMC Ratio|1.64|||||TWO_SIDED|95.0|1.42|1.89||||||||1.89|1.42|
73872456|NCT03197376|147287987|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 5 GMC Ratio|1.2|||||TWO_SIDED|95.0|1.03|1.4||||||||1.40|1.03|
73872457|NCT03197376|147287987|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 6A GMC Ratio|2.36|||||TWO_SIDED|95.0|2.01|2.78||||||||2.78|2.01|
73980105|NCT00046475|147505494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4||||0.004
73980106|NCT00046475|147505494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 5 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 5||||0.026
73872458|NCT03197376|147287987|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 6B GMC Ratio|1.45|||||TWO_SIDED|95.0|1.27|1.66||||||||1.66|1.27|
73872459|NCT03197376|147287987|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 7F GMC Ratio|1.29|||||TWO_SIDED|95.0|1.12|1.49||||||||1.49|1.12|
73872460|NCT03197376|147287987|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 9V GMC Ratio|0.94|||||TWO_SIDED|95.0|0.81|1.09||||||||1.09|0.81|
73980107|NCT00046475|147505494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 6 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 6||||0.226
73980108|NCT00046475|147505495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment composite symptom score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||0.002
73980109|NCT00046475|147505496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 1||||<0.001
73980110|NCT00046475|147505496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2||||<0.001
73980111|NCT00046475|147505496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3||||<0.001
74033010|NCT05281523|147619007|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.3||||0.066|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 26 in participants with a diagnosis of CRSwNP||0.0|-0.7|0.066
73872461|NCT03197376|147287987|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 14 GMC Ratio|1.41|||||TWO_SIDED|95.0|1.15|1.72||||||||1.72|1.15|
73872462|NCT03197376|147287987|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 19A GMC Ratio|1.38|||||TWO_SIDED|95.0|1.14|1.68||||||||1.68|1.14|
73872463|NCT03197376|147287987|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 19F GMC Ratio|0.61|||||TWO_SIDED|95.0|0.5|0.74||||||||0.74|0.50|
73872464|NCT03197376|147287987|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 23F GMC Ratio|1.5|||||TWO_SIDED|95.0|1.24|1.81||||||||1.81|1.24|
73980112|NCT00046475|147505496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4||||0.001
73980113|NCT00046475|147505497|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment global daily activity score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||<0.001
73980114|NCT00046475|147505500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline standing systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing systolic blood pressure||||0.002
73980115|NCT00046475|147505500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline standing diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing diastolic blood pressure||||0.010
73980116|NCT00046475|147505501|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline supine systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine systolic blood pressure||||<0.001
73980117|NCT00046475|147505501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline supine diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine diastolic blood pressure||||0.002
73980118|NCT00046475|147505502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.569|TWO_SIDED|||||The P-value is based on an ANOVA model with SF-36 general health score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of general health||||0.569
73872465|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 1 GMC Ratio|0.05|||||TWO_SIDED|95.0|0.05|0.06||||||||0.06|0.05|
73872466|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 5 GMC Ratio|0.3|||||TWO_SIDED|95.0|0.27|0.33||||||||0.33|0.27|
73872467|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6A GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.16||||||||0.16|0.13|
73872468|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6B GMC Ratio|0.11|||||TWO_SIDED|95.0|0.1|0.11||||||||0.11|0.10|
73872469|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 7F GMC Ratio|0.1|||||TWO_SIDED|95.0|0.09|0.11||||||||0.11|0.09|
73872470|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 9V GMC Ratio|0.21|||||TWO_SIDED|95.0|0.19|0.23||||||||0.23|0.19|
73872471|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 14 GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.17||||||||0.17|0.13|
73872472|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19A GMC Ratio|0.23|||||TWO_SIDED|95.0|0.2|0.26||||||||0.26|0.20|
73872473|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.15||||||||0.15|0.12|
73872474|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 23F GMC Ratio|0.11|||||TWO_SIDED|95.0|0.1|0.12||||||||0.12|0.10|
74033011|NCT05281523|147619008|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses.|Hazard Ratio (HR)|0.735||||0.128|TWO_SIDED|95.0|0.495|1.092|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.092|0.495|0.128
73872475|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 1 GMC Ratio|0.07|||||TWO_SIDED|95.0|0.06|0.08||||||||0.08|0.06|
73872476|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 5 GMC Ratio|0.4|||||TWO_SIDED|95.0|0.35|0.45||||||||0.45|0.35|
73872477|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6A GMC Ratio|0.73|||||TWO_SIDED|95.0|0.62|0.86||||||||0.86|0.62|
73872478|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6B GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
73872479|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 7F GMC Ratio|0.12|||||TWO_SIDED|95.0|0.11|0.13||||||||0.13|0.11|
73872480|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 9V GMC Ratio|0.2|||||TWO_SIDED|95.0|0.18|0.22||||||||0.22|0.18|
73872481|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 14 GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.19||||||||0.19|0.13|
73872482|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19A GMC Ratio|0.64|||||TWO_SIDED|95.0|0.52|0.78||||||||0.78|0.52|
73872483|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
73872484|NCT03197376|147287988|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 23F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
73872485|NCT03197376|147287989|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 1|24.2|||||TWO_SIDED|95.0|4.5|42.1||||||||42.1|4.5|
73872486|NCT03197376|147287989|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 5|9.9|||||TWO_SIDED|95.0|-5.8|25.5||||||||25.5|-5.8|
73872487|NCT03197376|147287989|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 6A|65.6|||||TWO_SIDED|95.0|48.3|78.0||||||||78.0|48.3|
74039489|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.49||0.0464|TWO_SIDED|95.0|-1.94|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-1.94|0.0464
73872488|NCT03197376|147287989|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 6B|23.2|||||TWO_SIDED|95.0|6.4|39.4||||||||39.4|6.4|
73872489|NCT03197376|147287989|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 7F|2.0|||||TWO_SIDED|95.0|-5.2|10.8||||||||10.8|-5.2|
73872490|NCT03197376|147287989|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 9V|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
73872491|NCT03197376|147287989|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type14|4.6|||||TWO_SIDED|95.0|-8.5|18.3||||||||18.3|-8.5|
73872492|NCT03197376|147287989|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 19A|34.4|||||TWO_SIDED|95.0|16.5|50.8||||||||50.8|16.5|
73872493|NCT03197376|147287989|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 19F|5.0|||||TWO_SIDED|95.0|-8.4|19.2||||||||19.2|-8.4|
73872494|NCT03197376|147287989|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 23F|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
73872495|NCT03197376|147287990|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 1|1.3|||||TWO_SIDED|95.0|0.8|2.1||||||||2.1|0.8|
73872496|NCT03197376|147287990|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 5|1.3|||||TWO_SIDED|95.0|0.7|2.4||||||||2.4|0.7|
73872497|NCT03197376|147287990|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 6A|14.3|||||TWO_SIDED|95.0|6.3|32.1||||||||32.1|6.3|
74033012|NCT05281523|147619009|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Hazard Ratio (HR)|0.713||||0.146|TWO_SIDED|95.0|0.453|1.124|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.124|0.453|0.146
73872498|NCT03197376|147287990|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 6B|3.7|||||TWO_SIDED|95.0|2.1|6.8||||||||6.8|2.1|
73872499|NCT03197376|147287990|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 7F|1.0|||||TWO_SIDED|95.0|0.6|1.6||||||||1.6|0.6|
73872500|NCT03197376|147287990|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 9V|0.7|||||TWO_SIDED|95.0|0.3|1.7||||||||1.7|0.3|
73872501|NCT03197376|147287990|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 14|1.1|||||TWO_SIDED|95.0|0.5|2.4||||||||2.4|0.5|
73872502|NCT03197376|147287990|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 19A|5.1|||||TWO_SIDED|95.0|2.4|10.8||||||||10.8|2.4|
73872503|NCT03197376|147287990|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 19F|1.0|||||TWO_SIDED|95.0|0.4|2.3||||||||2.3|0.4|
73872504|NCT03197376|147287990|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 23F|4.3|||||TWO_SIDED|95.0|2.0|9.4||||||||9.4|2.0|
73872505|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 1|0.04|||||TWO_SIDED|95.0|0.03|0.06||||||||0.06|0.03|
73872506|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 5|0.11|||||TWO_SIDED|95.0|0.09|0.14||||||||0.14|0.09|
73872507|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6A|0.05|||||TWO_SIDED|95.0|0.03|0.08||||||||0.08|0.03|
73872508|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6B|0.05|||||TWO_SIDED|95.0|0.03|0.07||||||||0.07|0.03|
73872509|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 7F|0.26|||||TWO_SIDED|95.0|0.18|0.38||||||||0.38|0.18|
73872510|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 9V|0.12|||||TWO_SIDED|95.0|0.06|0.23||||||||0.23|0.06|
73872511|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 14|0.07|||||TWO_SIDED|95.0|0.05|0.11||||||||0.11|0.05|
73872512|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19A|0.16|||||TWO_SIDED|95.0|0.09|0.3||||||||0.30|0.09|
73872513|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19F|0.09|||||TWO_SIDED|95.0|0.05|0.18||||||||0.18|0.05|
73872514|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 23F|0.12|||||TWO_SIDED|95.0|0.08|0.18||||||||0.18|0.08|
73872515|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 1|0.04|||||TWO_SIDED|95.0|0.03|0.06||||||||0.06|0.03|
73872516|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 5|0.07|||||TWO_SIDED|95.0|0.05|0.1||||||||0.10|0.05|
73872517|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6A|0.21|||||TWO_SIDED|95.0|0.09|0.48||||||||0.48|0.09|
73872518|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6B|0.02|||||TWO_SIDED|95.0|0.01|0.03||||||||0.03|0.01|
73872519|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 7F|0.44|||||TWO_SIDED|95.0|0.3|0.65||||||||0.65|0.30|
73872520|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 9V|0.11|||||TWO_SIDED|95.0|0.06|0.2||||||||0.20|0.06|
73872521|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 14|0.11|||||TWO_SIDED|95.0|0.06|0.22||||||||0.22|0.06|
73980119|NCT00046475|147505502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.578|TWO_SIDED|||||The P-value is based on an ANOVA model with SF-36 physical functioning score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of physical functioning||||0.578
73980120|NCT00046475|147505506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED|||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with mild or moderate disease severity||||0.370
73980121|NCT00046475|147505507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED|||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with marked or severe disease severity||||0.007
73980122|NCT02326220|147505541|SUPERIORITY||H-L estimate of median difference|0.75|||<|0.0001|TWO_SIDED|95.0|0.667|0.833||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|"Analysis was performed using the ranked analysis of covariance (ANCOVA) model with baseline frequency of the apheresis procedure (QW or Q2W) and Lp(a) levels (normal or elevated) as fixed effect and the baseline LDL-C level as a covariate. Hodges-Lehmann estimator of median difference (median of all pairwise differences; CI is Moses distribution free CI.~p-value is derived from the rank-based ANCOVA model. The model includes the baseline LDL-C value and stratification factors per IVRS."||0.833|0.667|< 0.0001
73980123|NCT02326220|147505542|SUPERIORITY||Least Square (LS) Mean Difference|-55.3|STANDARD_ERROR_OF_MEAN|3.9|<|0.0001|TWO_SIDED|95.0|-63.0|-47.5||Threshold for significance at 0.05 level.|MMRM|MMRM: Mixed-effect model with repeated measures|Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-47.5|-63.0|< 0.0001
73872522|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19A|0.26|||||TWO_SIDED|95.0|0.14|0.49||||||||0.49|0.14|
73872523|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19F|0.09|||||TWO_SIDED|95.0|0.06|0.14||||||||0.14|0.06|
73872524|NCT03197376|147287991|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 23F|0.07|||||TWO_SIDED|95.0|0.05|0.12||||||||0.12|0.05|
73872525|NCT03691571|147287995|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||Esophageal thermal injury was detected in 13/44 (30%) patients.||||>.05
73872526|NCT03691571|147287997|OTHER|feasibility/pilot study||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
73872527|NCT03691571|147287998|OTHER|feasibility/pilot study||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
73872528|NCT03691571|147287999|OTHER|feasibility/pilot study||||||0.1|||||||Fisher Exact|||||||0.10
73872529|NCT00186901|147288004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.86||95.0|||||Wilcoxon Test|||Baseline where N=134||||0.86
73872530|NCT00186901|147288004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.17||||0.99||95.0|||||Wilcoxon Test|||12 Month BMD Z-Score Calculation where N=109||||0.99
73872531|NCT00186901|147288004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.54||95.0|||||Wilcoxon Test|||24 Month BMD Z-Score calculation where N=91||||0.54
73872532|NCT00186901|147288004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.31||95.0|||||Wilcoxon Test|||36 Month (End of Study) BMD Z-Score calculation where N=84||||0.31
73872533|NCT00186901|147288005|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.32||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
73872534|NCT00186901|147288006|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.69||||0.0023||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0023
73872535|NCT00186901|147288007|SUPERIORITY_OR_OTHER|||||||0.0092||95.0|||||Kruskal-Wallis|||||||0.0092
73872536|NCT00186901|147288008|SUPERIORITY_OR_OTHER||Correlation coefficient|0.41|||<|0.0001|TWO_SIDED|95.0|0.25|0.55|||Z-test|||275 received a QCT and 121 received a DXA scan. 121 paired scans were evaluated.||0.55|0.25|<0.0001
73872537|NCT00186901|147288009|SUPERIORITY_OR_OTHER||Correlation coefficient|0.54|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Z-test|||218 patients were assessed at 12 months and received a QCT Scan. 94 patients were also assessed using the DEXA Scan. Comparison of the two methods used 94 paired studies to arrive at a correlation coefficient.||0.67|0.38|<0.0001
73872538|NCT00186901|147288010|SUPERIORITY_OR_OTHER||Correlation coefficient|0.53|||<|0.0001|TWO_SIDED|95.0|0.36|0.66|||Z-test|||188 patients were assessed at baseline and received a QCT Scan. 90 patients were also assessed using the DEXA Scan. Comparison of the two methods used 90 paired studies to arrive at a correlation coefficient.||0.66|0.36|<0.0001
73872539|NCT00186901|147288011|SUPERIORITY_OR_OTHER||Correlation coefficient|0.48|||<|0.0001|TWO_SIDED|95.0|0.3|0.63|||Z-test|||180 patients were assessed at 36 months and received a QCT Scan. 89 patients were also assessed using the DXA Scan. Comparison of the two methods used 89 paired studies to arrive at a correlation coefficient.||0.63|0.30|<0.0001
73872540|NCT00186901|147288012|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Kruskal Wallis|||||||0.40
73872541|NCT00186901|147288013|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Kruskal Wallis|||||||0.21
73872542|NCT00291486|147288048|SUPERIORITY|||||||0.144|||||||t-test, 1 sided|||Comparison of CL between initial infusion and therapy infusion||||0.144
73872543|NCT00291486|147288049|SUPERIORITY|||||||0.361|||||||ANOVA|||||||0.361
73872544|NCT01099397|147288054|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value at baseline|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at baseline; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.41
73872545|NCT01099397|147288054|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value at 9 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at 9 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.59
73872546|NCT01099397|147288054|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||P-value at 18 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at 18 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.41
73872547|NCT03421106|147288055|SUPERIORITY||Mean Difference (Net)|2.53||||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||0.23
73872548|NCT01025830|147288064|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.87|1.38||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||1.38|0.87|
73872549|NCT01025830|147288064|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.31||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||1.31|0.95|
73872550|NCT01025830|147288064|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|0.8||||||90.0|0.65|0.99||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||0.99|0.65|
73872551|NCT01025830|147288065|NON_INFERIORITY_OR_EQUIVALENCE|same as for AUC|Geometric Mean Ratio|1.3||||||90.0|0.99|1.71||same as for AUC|Non-compartmental model|same as for AUC|same as AUC|Same as for AUC||1.71|0.99|
73872552|NCT01025830|147288065|NON_INFERIORITY_OR_EQUIVALENCE|same for all three drugs.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.23||Same for all three drugs.|Non-compartmental model|Same for all three drugs.|Same for all three drugs.|Same for all three drugs.||1.23|0.95|
73980124|NCT02326220|147505543|SUPERIORITY||H-L estimate of median difference|0.5|||<|0.0001|TWO_SIDED|95.0|0.5|1.0||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.000|0.500|<.0001
73980125|NCT02326220|147505544|SUPERIORITY||LS Mean Difference|-44.0|||<|0.0001|TWO_SIDED|95.0|-51.3|-36.6||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.6|-51.3|< 0.0001
73872553|NCT01025830|147288065|NON_INFERIORITY_OR_EQUIVALENCE|Same for all three drugs.|Geometric Mean Ratio|0.8||||||90.0|0.63|0.98||Same for all three drugs.|Non-compartmental model|Same for all three drugs.|Same for all three drugs.|Same for all three drugs.||0.98|0.63|
73872554|NCT00264537|147288070|SUPERIORITY_OR_OTHER|||||||0.053||||||A positive test is concluded if there is a significant difference between golimumab+MTX and placebo+MTX and at least one of the pair-wise comparisons at a 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Group 1 vs combined Groups 3 and 4. The sample size of 150 patients per treatment group will provide \>98% power to detect a difference in ACR 50 response between treatment groups at alpha=0.05, assuming 50% of patients with screening C-reactive protein (CRP)\<1.5mg/dL, and the difference in ACR 50 response of 15-20% in patients with screening CRP\<1.5mg/dL and 20-25% in subjects with screening CRP\>=1.5mg/dL, between Groups 1 vs 3 or 4||||0.053
73872555|NCT00264537|147288070|SUPERIORITY_OR_OTHER|||||||0.042|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 3.||||0.042
73872556|NCT00264537|147288070|SUPERIORITY_OR_OTHER|||||||0.177|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 4.||||0.177
73872557|NCT00264537|147288070|NON_INFERIORITY_OR_EQUIVALENCE|This sample size (150 patients per treatment group) will provide approximately 85% power to claim non-inferiority of golimumab alone (Group 2) compared with MTX alone (Group 1) at alpha= 0.05 using a one-sided equivalence test assuming the proportion of golimumab alone (Group 2) treated patients with ACR 50 response is not less than 10% compared with proportion of patients with ACR 50 response in MTX alone (Group 1) treated group.|Difference in ACR 50 Response Rate(%)|3.3||||0.521||95.0|-6.8||The upper bound of 95% CI was not produced because it was not relevant to the pre-specified analysis||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)|The positive difference indicates in favor of golimumab+placebo compared to placebo+MTX; The upper bound of CI is not applicable.|"Null hypothesis: Group 2 is inferior to Group 1. Noninferiority of golimumab will be demonstrated if the lower bound of the 2-sided 95% CI is above -10%. The 10% non-inferiority margin was chosen because this difference is not clinically admissible. Under the above noted assumed response rates, this corresponds to preservation of at least 70% \[(33% - 10%)/33%\*100\] of the expected MTX benefit."|||-6.8|0.521
73872558|NCT00264537|147288071|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.011
73872559|NCT00264537|147288071|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.028
73872560|NCT00264537|147288071|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.028
73980126|NCT02326220|147505545|SUPERIORITY||LS Mean Difference|-50.0|||<|0.0001|TWO_SIDED|95.0|-57.3|-42.7||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.7|-57.3|< 0.0001
73980127|NCT02326220|147505546|SUPERIORITY||LS Mean Difference|-39.4|||<|0.0001|TWO_SIDED|95.0|-45.6|-33.2||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.2|-45.6|< 0.0001
73980128|NCT02326220|147505547|SUPERIORITY||LS Mean Difference|4.2||||0.3012|TWO_SIDED|95.0|-3.9|12.3||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.3|-3.9|0.3012
73980129|NCT00286325|147505587|SUPERIORITY_OR_OTHER||||||=|0.0156||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon comparing week zero antibody value in units to week 24 antibody value in units||||=0.0156
73980130|NCT00286325|147505588|SUPERIORITY_OR_OTHER||||||=|0.0078|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Comparison of B cell number at week 0 to b cell number in participants at week 24||||=0.0078
73980131|NCT02699099|147505589|NON_INFERIORITY|Non-inferiority (1 month post-Dose 3 of SB257049) was defined as the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (RTS,S group/Coad group) for anti-CS, being below a limit of 2.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07|||ANOVA|||Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.||1.07|0.81|
73872561|NCT00264537|147288071|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.677
73872562|NCT00264537|147288072|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.178
73872563|NCT00264537|147288072|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.250
73872564|NCT00264537|147288072|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.240
73872565|NCT00264537|147288072|SUPERIORITY_OR_OTHER|||||||0.339||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.339
74039490|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.49||0.0068|TWO_SIDED|95.0|-2.3|-0.37|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.37|-2.30|0.0068
73872566|NCT00264537|147288073|SUPERIORITY_OR_OTHER|||||||0.006||||||If this test is significant, a pairwise comparison between Group 3 and Group 1, and between Group 4 and Group 1 will be performed|ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; ≥ 1.5 mg/dL)||Null Hypothesis: No difference in vdH-S score comparing Groups 1 vs Groups 3 and 4 combined. The sample size of 150 subjects in each treatment group (Group 1, Group 3, Group 4) will provide \> 95% power to detect a difference in the vdH-S score between treatment groups using a 2-sided t-test on van der Waerden normal scores of change from baseline in vdH-S score at α = 0.05, assuming a mean change from baseline in vdH-S score of 3.5 for the placebo group and 1 for Groups 3 and 4.||||0.006
73872567|NCT00264537|147288073|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 3.||||0.015
73872568|NCT00264537|147288073|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 4.||||0.025
73872569|NCT00264537|147288074|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.003
73872570|NCT00264537|147288074|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.010
73872571|NCT00264537|147288074|SUPERIORITY_OR_OTHER|||||||0.014|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.014
73872572|NCT00264537|147288074|SUPERIORITY_OR_OTHER|||||||0.545|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.545
73872573|NCT00999544|147288079|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Area-under-the-curve (AUC) scores were derived from time course data and analyzed using two-factor ANOVA \[aprepitant dose (3 levels)x oxycodone dose (3 levels)\].~All analyses were conducted using SAS 9.1 for Windows (SAS Institute Inc., Cary, NC, USA) and were considered significant when P 0.05."||||<.05
73872574|NCT02936635|147288089|SUPERIORITY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|3.619||0.2821|TWO_SIDED|95.0|-11.035|3.23|||Mixed Models Analysis|||||3.23|-11.035|0.2821
73872575|NCT02936635|147288090|SUPERIORITY||Median Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|4.242||0.2118|TWO_SIDED|95.0|-13.711|3.067|||Mixed Models Analysis|||||3.067|-13.711|0.2118
73872576|NCT02936635|147288091|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|1.205||0.6354|TWO_SIDED|95.0|-2.946|1.801|||Mixed Models Analysis|||||1.801|-2.946|0.6354
73872577|NCT02936635|147288092|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.509||0.8887|TWO_SIDED|95.0|-3.186|2.763|||Mixed Models Analysis|||||2.763|-3.186|0.8887
73872578|NCT02309944|147288107|SUPERIORITY|||||||0.27|TWO_SIDED|95.0|||||Chi-squared|||Negative Pressure Wound Therapy vs. Standard Wound Closure||||0.27
73872579|NCT02309944|147288107|SUPERIORITY|||||||0.24|||||||Regression, Logistic|Multivariate Model (adjusted for ascites and previous laparotomy)||Negative Pressure Wound Therapy vs. Standard Wound Closure||||0.24
73872580|NCT01525615|147288130|SUPERIORITY_OR_OTHER||Treatment ratio|1.138|STANDARD_ERROR_OF_MEAN|0.063||0.0209|TWO_SIDED|95.0|1.02|1.269||Mixed effects Model for Repeated Measures (MMRM) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time), log10 (baseline endurance time) by test day interaction, and patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. This treatment comparison is the first one in the alpha-protected hierarchical testing chain.||1.269|1.020|0.0209
73872581|NCT01525615|147288130|SUPERIORITY_OR_OTHER||Treatment ratio|1.086|STANDARD_ERROR_OF_MEAN|0.061||0.1419|TWO_SIDED|95.0|0.973|1.213||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. This treatment comparison is the second one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is \>0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.||1.213|0.973|0.1419
73952823|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
73952824|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-16.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-16.0|<0.001
73952825|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
73952826|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
73872582|NCT01525615|147288130|SUPERIORITY_OR_OTHER||Treatment ratio|1.047|STANDARD_ERROR_OF_MEAN|0.057||0.397|TWO_SIDED|95.0|0.941|1.166||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.||1.166|0.941|0.3970
73872583|NCT01525615|147288131|SUPERIORITY_OR_OTHER||Tretament ratio|1.209|STANDARD_ERROR_OF_MEAN|0.119||0.0552|TWO_SIDED|95.0|0.996|1.467||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Since the hierarchical testing chain has been broken, even though this treatment comparison is included as the 3rd one in the alpha-protected hierarchical testing chain, this hypothesis test is descriptive only.||1.467|0.996|0.0552
73872584|NCT01525615|147288131|SUPERIORITY_OR_OTHER||Treatment ratio|1.211|STANDARD_ERROR_OF_MEAN|0.121||0.0562|TWO_SIDED|95.0|0.995|1.475||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean, 95% confidence limits transformed from log10 to original scale. SE was calculated using the delta method. This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo||1.475|0.995|0.0562
73872585|NCT01525615|147288131|SUPERIORITY_OR_OTHER||Treatment ratio|0.998|STANDARD_ERROR_OF_MEAN|0.095||0.9822|TWO_SIDED|95.0|0.826|1.205||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.||1.205|0.826|0.9822
73872586|NCT01525615|147288132|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.234|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.133|0.336||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.|LSMean=Least square mean.|||0.336|0.133|<0.0001
73872587|NCT01525615|147288132|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.207|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.105|0.309||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.||||0.309|0.105|<0.0001
73872588|NCT01525615|147288132|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.027|STANDARD_ERROR_OF_MEAN|0.05||0.5892|TWO_SIDED|95.0|-0.072|0.126||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.||||0.126|-0.072|0.5892
73872589|NCT01525615|147288133|SUPERIORITY_OR_OTHER||Treatment ratio|1.126|STANDARD_ERROR_OF_MEAN|0.059||0.0245|TWO_SIDED|95.0|1.015|1.248||ANCOVA model for log10 (endurance time \[s\]) with categorical effects of treatment and (log10-transformed) baseline as continuous covariate.|ANCOVA|This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo||1.248|1.015|0.0245
73872590|NCT01525615|147288133|SUPERIORITY_OR_OTHER||Treatment ratio|1.103|STANDARD_ERROR_OF_MEAN|0.058||0.0655|TWO_SIDED|95.0|0.994|1.223|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 2.5/5.0 and placebo||1.223|0.994|0.0655
73872591|NCT01525615|147288133|SUPERIORITY_OR_OTHER||Treatment ratio|1.021|STANDARD_ERROR_OF_MEAN|0.053||0.6912|TWO_SIDED|95.0|0.921|1.132|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0||1.132|0.921|0.6912
73872592|NCT01525615|147288134|SUPERIORITY_OR_OTHER||Treatment ratio|1.229|STANDARD_ERROR_OF_MEAN|0.068||0.0002|TWO_SIDED|95.0|1.103|1.37||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Hypothesis test is descriptive||1.370|1.103|0.0002
73952827|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-15.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-15.0|<0.001
73952828|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.1||0.019|TWO_SIDED|95.0|-9.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-9.0|0.019
73952829|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.1||0.007|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.007
73872593|NCT01525615|147288134|SUPERIORITY_OR_OTHER||Treatment ratio|1.221|STANDARD_ERROR_OF_MEAN|0.068||0.0004|TWO_SIDED|95.0|1.095|1.362||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. Hypothesis test is descriptive.||1.362|1.095|0.0004
73872594|NCT01525615|147288134|SUPERIORITY_OR_OTHER||Treatment ratio|1.006|STANDARD_ERROR_OF_MEAN|0.055||0.9062|TWO_SIDED|95.0|0.905|1.12||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. Hypothesis test is descriptive.||1.12|0.905|0.9062
73872595|NCT01525615|147288135|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.165|STANDARD_ERROR_OF_MEAN|0.058||0.0049|TWO_SIDED|95.0|0.051|0.279||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.279|0.051|0.0049
73872596|NCT01525615|147288135|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.202|STANDARD_ERROR_OF_MEAN|0.058||0.0006|TWO_SIDED|95.0|0.088|0.316||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.316|0.088|0.0006
73872597|NCT01525615|147288135|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.037|STANDARD_ERROR_OF_MEAN|0.058||0.5162|TWO_SIDED|95.0|-0.151|0.076||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.076|-0.151|0.5162
73872598|NCT01525615|147288136|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.225|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.124|0.326||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.326|0.124|<0.0001
73872599|NCT01525615|147288136|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.187|STANDARD_ERROR_OF_MEAN|0.052||0.0003|TWO_SIDED|95.0|0.086|0.288||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.288|0.086|0.0003
73872600|NCT01525615|147288136|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.038|STANDARD_ERROR_OF_MEAN|0.05||0.4541|TWO_SIDED|95.0|-0.061|0.137||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.137|-0.061|0.4541
73980132|NCT02699099|147505594|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rate of the anti-measles antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|2.05|||||TWO_SIDED|95.0|-1.29|5.89|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||Difference in seroconversion rates against measles antibodies: To demonstrate the non-inferiority of the antibody response to the measles vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.||5.89|-1.29|
73980133|NCT02699099|147505597|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rates of the anti-rubella antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.5|||||TWO_SIDED|95.0|-1.29|2.78|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||"Difference in seroconversion rates against Rubella antibodies: To demonstrate the non-inferiority of the antibody response to the rubella vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered.~with SB257049 versus administration without SB257049."||2.78|-1.29|
74039491|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.5||0.1485|TWO_SIDED|95.0|-1.7|0.26|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.26|-1.70|0.1485
73872601|NCT01525615|147288137|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0468|TWO_SIDED|95.0|-0.004|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||-0.000|-0.004|0.0468
73872602|NCT01525615|147288137|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.018|TWO_SIDED|95.0|-0.005|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||-0.000|-0.005|0.0180
73872603|NCT01525615|147288137|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.6856|TWO_SIDED|95.0|-0.002|0.002||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.002|-0.002|0.6856
73872604|NCT01525615|147288138|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0081|TWO_SIDED|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.001|-0.005|0.0081
73872605|NCT01525615|147288138|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0099|TWO_SIDED|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.001|-0.005|0.0099
73872606|NCT01525615|147288138|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.9626|TWO_SIDED|95.0|-0.002|0.002||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.002|-0.002|0.9626
73872607|NCT01525615|147288139|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0598|TWO_SIDED|95.0|-0.004|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.000|-0.004|0.0598
73872608|NCT01525615|147288139|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0218|TWO_SIDED|95.0|-0.005|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.000|-0.005|0.0218
73872609|NCT01525615|147288139|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.6549|TWO_SIDED|95.0|-0.002|0.003||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.003|-0.002|0.6549
73872610|NCT01525615|147288140|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.17|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.116|0.224||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.224|0.116|<0.0001
73872611|NCT01525615|147288140|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.184|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.129|0.239||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.239|0.129|<0.0001
73872612|NCT01525615|147288140|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.014|STANDARD_ERROR_OF_MEAN|0.027||0.6105|TWO_SIDED|95.0|-0.067|0.04||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.040|-0.067|0.6105
73872613|NCT01525615|147288141|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.246|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.192|0.3||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.300|0.192|<0.0001
73872614|NCT01525615|147288141|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.273|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.218|0.328||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.328|0.218|<0.0001
73872615|NCT01525615|147288141|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.027|STANDARD_ERROR_OF_MEAN|0.027||0.3236|TWO_SIDED|95.0|-0.08|0.027||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.027|-0.080|0.3236
73872616|NCT01525615|147288142|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.251|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.196|0.305||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.305|0.196|<0.0001
73872617|NCT01525615|147288142|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.257|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.202|0.312||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.312|0.202|<0.0001
73872618|NCT01525615|147288142|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.006|STANDARD_ERROR_OF_MEAN|0.027||0.8156|TWO_SIDED|95.0|-0.06|0.047||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.047|-0.060|0.8156
73872619|NCT03777059|147288198|SUPERIORITY||Least Squares Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.291|<|0.0001|TWO_SIDED|95.0|-1.78|-0.64||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.64|-1.78|<.0001
73872620|NCT03777059|147288198|SUPERIORITY||Least Squares Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.287|<|0.0001|TWO_SIDED|95.0|-1.94|-0.82||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.82|-1.94|<.0001
73872621|NCT03777059|147288198|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.288|<|0.0001|TWO_SIDED|95.0|-2.28|-1.15||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.15|-2.28|<.0001
73872622|NCT03777059|147288199|SUPERIORITY||Least Squares Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.311|<|0.0001|TWO_SIDED|95.0|-2.03|-0.81||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.81|-2.03|<.0001
73872623|NCT03777059|147288199|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.307|<|0.0001|TWO_SIDED|95.0|-2.13|-0.92||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.92|-2.13|<.0001
73872624|NCT03777059|147288199|SUPERIORITY||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.309|<|0.0001|TWO_SIDED|95.0|-2.32|-1.1||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.10|-2.32|<.0001
73872625|NCT03777059|147288200|SUPERIORITY||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|-1.81|-0.82||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.82|-1.81|<.0001
73872626|NCT03777059|147288200|SUPERIORITY||Least Squares Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|-1.82|-0.83||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.83|-1.82|<.0001
73872627|NCT03777059|147288200|SUPERIORITY||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|-2.0|-1.01||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.01|-2.00|<.0001
73872628|NCT03777059|147288201|SUPERIORITY||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|2.05|4.56||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||4.56|2.05|<.0001
73872629|NCT03777059|147288201|SUPERIORITY||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.37|5.26||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||5.26|2.37|<.0001
73872630|NCT03777059|147288201|SUPERIORITY||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.56|5.71||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||5.71|2.56|<.0001
73872631|NCT03777059|147288202|SUPERIORITY||Least Squares Mean Difference|9.9|STANDARD_ERROR_OF_MEAN|2.27|<|0.0001|TWO_SIDED|95.0|5.45|14.36||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||14.36|5.45|<.0001
73980134|NCT02699099|147505600|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seropositivity rates of the anti-yellow fever antibody , being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.55|||||TWO_SIDED|95.0|-2.3|3.65|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||Difference in seropositivity rates against Yellow Fever antibodies: To demonstrate the non-inferiority of the antibody response to the YF vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.||3.65|-2.30|
74033013|NCT05281523|147619010|OTHER|Logistic regression with covariates of treatment, number of courses of systemic CS in 12 months prior to screening for NP (0, 1,\>1), log(e) baseline blood eosinophil count, baseline total endoscopic NP score, baseline nasal obstruction score (VRS), region, study and previous surgery for NPs. The study covariate is removed for individual study analyses. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Odds Ratio (OR)|0.58||||0.006|TWO_SIDED|95.0|0.4|0.86|||Regression, Logistic|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||0.86|0.40|0.006
73872632|NCT03777059|147288202|SUPERIORITY||Least Squares Mean Difference|10.08|STANDARD_ERROR_OF_MEAN|2.229|<|0.0001|TWO_SIDED|95.0|5.71|14.46||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||14.46|5.71|<.0001
73872633|NCT03777059|147288202|SUPERIORITY||Least Squares Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|2.231|<|0.0001|TWO_SIDED|95.0|6.42|15.18||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||15.18|6.42|<.0001
73872634|NCT03777059|147288203|SUPERIORITY||Least Squares Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.693||0.0856|TWO_SIDED|95.0|-2.56|0.17||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||0.17|-2.56|0.0856
73872635|NCT03777059|147288203|SUPERIORITY||Least Squares Mean Difference|-2.54|STANDARD_ERROR_OF_MEAN|0.694||0.0003|TWO_SIDED|95.0|-3.91|-1.18||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.18|-3.91|0.0003
73872636|NCT03777059|147288203|SUPERIORITY||Least Squares Mean Difference|-3.32|STANDARD_ERROR_OF_MEAN|0.694|<|0.0001|TWO_SIDED|95.0|-4.68|-1.96||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.96|-4.68|<.0001
73872637|NCT03777059|147288204|SUPERIORITY||Least Squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.605||0.0743|TWO_SIDED|95.0|-2.27|0.11||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||0.11|-2.27|0.0743
73872638|NCT03777059|147288204|SUPERIORITY||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.606||0.0011|TWO_SIDED|95.0|-3.18|-0.8||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.80|-3.18|0.0011
73872639|NCT03777059|147288204|SUPERIORITY||Least Squares Mean Difference|-2.46|STANDARD_ERROR_OF_MEAN|0.605|<|0.0001|TWO_SIDED|95.0|-3.65|-1.28||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.28|-3.65|<.0001
73872640|NCT01173601|147288213|SUPERIORITY_OR_OTHER|||||||0.338||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis|||||||0.338
73872641|NCT01173601|147288213|SUPERIORITY_OR_OTHER|||||||0.201||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis|||||||0.201
73872642|NCT03951077|147288234|SUPERIORITY||Adjusted Response Rate Difference|-5.9||||0.3|TWO_SIDED|90.0|-15.38|3.49|||Cochran-Mantel-Haenszel|||Across the strata, 90% confidence interval (CI) for adjusted difference and p-value were calculated according to the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.49|-15.38|0.300
73872643|NCT03951077|147288234|SUPERIORITY||Adjusted Response Rate Difference|-5.9||||0.32|TWO_SIDED|90.0|-15.65|3.86|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.86|-15.65|0.320
73872644|NCT03951077|147288234|SUPERIORITY||Adjusted Response Rate Difference|-5.6||||0.315|TWO_SIDED|90.0|-14.87|3.59|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.59|-14.87|0.315
73872645|NCT03951077|147288234|SUPERIORITY||Adjusted Response Rate Difference|-6.7||||0.265|TWO_SIDED|90.0|-16.63|3.19|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.19|-16.63|0.265
73980135|NCT02699099|147505626|NON_INFERIORITY|Non-inferiority (1 month post-Dose 3 of SB257049) was defined as the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (RTS,S group/Coad group) for anti-CS, being below a limit of 2.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07|||ANOVA|||Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.||1.07|0.81|
73980136|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980137|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980138|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73872646|NCT03951077|147288234|SUPERIORITY||Adjusted Response Rate Difference|-0.8||||0.914|TWO_SIDED|90.0|-13.1|11.48|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||11.48|-13.10|0.914
73872647|NCT03951077|147288235|SUPERIORITY||Least Squares (LS) Mean of Difference|-5.93|STANDARD_ERROR_OF_MEAN|3.429||0.087|TWO_SIDED|90.0|-11.628|-0.231|||MMRM|||P-value is from mixed-effect model repeated measure (MMRM) with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-0.231|-11.628|0.087
73980139|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
73872648|NCT03951077|147288235|SUPERIORITY||LS Mean of Difference|-8.83|STANDARD_ERROR_OF_MEAN|3.435||0.012|TWO_SIDED|90.0|-14.533|-3.118|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-3.118|-14.533|0.012
73872649|NCT03951077|147288235|SUPERIORITY||LS Mean of Difference|-16.1|STANDARD_ERROR_OF_MEAN|3.356|<|0.001|TWO_SIDED|90.0|-21.673|-10.519|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-10.519|-21.673|<0.001
73872650|NCT03951077|147288235|SUPERIORITY||LS Mean of Difference|-6.15|STANDARD_ERROR_OF_MEAN|3.593||0.091|TWO_SIDED|90.0|-12.116|-0.176|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-0.176|-12.116|0.091
73872651|NCT03951077|147288235|SUPERIORITY||LS Mean of Difference|-11.72|STANDARD_ERROR_OF_MEAN|3.431|<|0.001|TWO_SIDED|90.0|-17.418|-6.016|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-6.016|-17.418|< 0.001
73872652|NCT01395901|147288237|NON_INFERIORITY_OR_EQUIVALENCE|For the primary efficacy analysis, the confidence interval (CI) was built on the FAS using the stratum adjusted Mantel-Haenszel (MH) method with correction of continuity. The non-inferiority margin was -10%.|Risk Difference (RD)|-4.4|||||TWO_SIDED|95.0|-10.5|1.7||||||"The null hypothesis (H0) was stated as:~• H0 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron \<-10%~The alternative hypothesis (H1) was stated as:~• H1 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron \>-10%~A power of 80% was used for sample size computation."||1.7|-10.5|
73872653|NCT02123849|147288276|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.04|||||||t-test, 1 sided|||||||0.04
73872654|NCT02123849|147288277|OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
73872655|NCT02123849|147288278|OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
73872656|NCT02123849|147288279|OTHER|||||||1|||||||Fisher Exact|||||||1.00
73980140|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980141|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73980142|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980143|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980144|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|-2.2|||||TWO_SIDED|95.0|-15.7|10.9||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-15.7|
73872657|NCT02123849|147288280|OTHER|||||||0.42|||||||t-test, 2 sided|||||||0.42
73872658|NCT02123849|147288281|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided|||||||0.97
73872659|NCT02123849|147288282|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided|||||||0.97
73872660|NCT02123849|147288283|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.06|||||||t-test, 1 sided|||||||0.06
73872661|NCT02178995|147288299|SUPERIORITY_OR_OTHER|||||||0.037||||||HRTSD p-value = 0.037; p \< 0.05 considered significant|ANOVA|Within-subjects contrasts, n=31, df=1||||||0.037
73872662|NCT02178995|147288299|SUPERIORITY_OR_OTHER|||||||0.055||||||D' p = 0.055. p \< 0.05 considered significant.|ANOVA|Within-subjects contrasts, placebo v 10mg v 20mg.||||||0.055
73872663|NCT02178995|147288299|SUPERIORITY_OR_OTHER|||||||0.758|||||||t-test, 2 sided|||HRTSD 10mg vs 20mg||||0.758
73872664|NCT02178995|147288299|SUPERIORITY_OR_OTHER|||||||0.499|||||||t-test, 2 sided|||d' 10mg vs 20mg||||0.499
73872665|NCT02178995|147288300|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANOVA|||||||0.008
73980145|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980146|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73872666|NCT02178995|147288300|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||SDMT 10mg vs 20mg||||0.071
73872667|NCT02178995|147288301|SUPERIORITY_OR_OTHER|||||||0.154|||||||ANOVA|||||||0.154
73872668|NCT02178995|147288301|SUPERIORITY_OR_OTHER|||||||0.779|||||||t-test, 2 sided|||MCG 10mg vs 20mg||||0.779
73872669|NCT02178995|147288302|SUPERIORITY_OR_OTHER||||||<|0.0001||||||HRTSD P\<0.0001|t-test, 2 sided|||Intra-group comparison, HRTSD||||<0.0001
73872670|NCT02178995|147288302|SUPERIORITY_OR_OTHER|||||||0.001||||||HRTSD p \<0.001 for healthy controls|t-test, 2 sided|||Intra-group comparison, HRTSD, healthy controls||||0.001
73872671|NCT02178995|147288302|SUPERIORITY_OR_OTHER|||||||0.322|||||||ANOVA|||Between-group comparisons by 2-way ANOVA, HRTSD||||0.322
73872672|NCT02178995|147288302|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Intra-group comparison, epilepsy, D'||||<0.0001
73872673|NCT02178995|147288302|SUPERIORITY_OR_OTHER|||||||0.037|||||||t-test, 2 sided|||Intra-group analysis, healthy controls, d'||||0.037
73980147|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980148|NCT00824850|147505630|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980149|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|9.0|||||TWO_SIDED|95.0|-5.6|25.5||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||25.5|-5.6|
73980150|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980151|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
73980152|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|5.7|||||TWO_SIDED|95.0|-4.2|19.2||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||19.2|-4.2|
73980153|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|3.1|||||TWO_SIDED|95.0|-9.3|17.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.0|-9.3|
73872674|NCT02178995|147288302|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||Intra-group analysis by 2-way ANOVA, d'||||0.08
73872675|NCT02178995|147288303|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
73872676|NCT02178995|147288303|SUPERIORITY_OR_OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
73872677|NCT02178995|147288303|SUPERIORITY_OR_OTHER|||||||0.443|||||||ANOVA|||Group x time interaction by 2-way ANOVA||||0.443
73872678|NCT02178995|147288304|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73980154|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73980155|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980156|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
73980157|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|6.9|||||TWO_SIDED|95.0|-7.4|23.4||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||23.4|-7.4|
73980158|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73872679|NCT02178995|147288304|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
73872680|NCT02178995|147288304|SUPERIORITY_OR_OTHER|||||||0.906|||||||ANOVA|||Between-groups analysis by 2-way ANOVA||||0.906
73872681|NCT02178995|147288305|SUPERIORITY_OR_OTHER|||||||0.274|||||||t-test, 2 sided|||||||0.274
73872682|NCT02178995|147288306|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73872683|NCT02178995|147288307|SUPERIORITY_OR_OTHER|||||||0.04||||||Hits p = 0.04|ANOVA|||||||0.04
73872684|NCT02178995|147288307|SUPERIORITY_OR_OTHER|||||||0.038||||||Omissions p = 0.038|ANOVA|||||||0.038
73872685|NCT02178995|147288307|SUPERIORITY_OR_OTHER|||||||0.329||||||Commissions p = 0.329|ANOVA|||||||0.329
73872686|NCT02178995|147288307|SUPERIORITY_OR_OTHER|||||||0.876|||||||t-test, 2 sided|||Hits 10mg vs 20mg||||0.876
73872687|NCT02178995|147288307|SUPERIORITY_OR_OTHER|||||||0.932|||||||t-test, 2 sided|||Omissions 10mg vs 20mg||||0.932
73872688|NCT02178995|147288307|SUPERIORITY_OR_OTHER|||||||0.898|||||||t-test, 2 sided|||Commissions 10mg vs 20mg||||0.898
73872689|NCT02178995|147288308|SUPERIORITY_OR_OTHER|||||||0.7116|||||||t-test, 2 sided|||Comparison of baseline rate of seizures (expressed as seizures per 28 days) pre-trial against the rate experienced during the double-blind portion of our trial.||||0.7116
73872690|NCT02178995|147288309|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Attention/Concentration subscale||||<0.0001
73872691|NCT02178995|147288309|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Memory subscale||||<0.0001
73872692|NCT02178995|147288309|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Language subscale||||0.002
73872693|NCT02178995|147288309|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Energy/fatigue subscale||||0.001
73872694|NCT02178995|147288310|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||Hits v1 vs v5 epilepsy||||0.003
73872695|NCT02178995|147288310|SUPERIORITY_OR_OTHER|||||||0.033|||||||t-test, 2 sided|||Hits v1 vs v5 healthy||||0.033
73872696|NCT02178995|147288310|SUPERIORITY_OR_OTHER|||||||0.079|||||||ANOVA|||2-way ANOVA epilepsy vs healthy hits||||0.079
73872697|NCT02178995|147288310|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Omissions epilepsy v1 vs v5||||0.001
73872698|NCT02178995|147288310|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||Omissions v1 vs v5 healthy||||0.029
73872699|NCT02178995|147288310|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||Epilepsy v healthy ANOVA Omissions||||0.048
73872700|NCT02178995|147288310|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Commissions v1 vs v5 epilepsy||||<0.0001
73872701|NCT02178995|147288310|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||Commissions v1 vs v5 healthy||||0.42
73872702|NCT02178995|147288310|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANOVA|||Healthy vs epilepsy ANOVA (2-way) commissions||||0.019
73872703|NCT02178995|147288311|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73872704|NCT02178995|147288312|SUPERIORITY_OR_OTHER|||||||0.003||||||Note: Stimulant side-effect score \*decreased\* with addition of open-label stimulant.|t-test, 2 sided|||||||0.003
73872705|NCT02178995|147288313|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||BDI epilepsy v1 vs v5||||0.014
73980159|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980160|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
74089442|NCT02697773|147731641|SUPERIORITY||Odds Ratio (OR)|0.77||||0.1712|TWO_SIDED|95.0|0.53|1.12|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.12|0.53|0.1712
73872706|NCT02178995|147288313|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Healthy controls BDI v1 vs v5||||0.04
73872707|NCT02178995|147288313|SUPERIORITY_OR_OTHER|||||||0.191|||||||t-test, 2 sided|||Between-group comparison 2-way ANOVA BDI||||0.191
73872708|NCT02178995|147288313|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 epilepsy||||0.42
73872709|NCT02178995|147288313|SUPERIORITY_OR_OTHER|||||||0.477|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 healthy controls||||0.477
73872710|NCT02178995|147288313|SUPERIORITY_OR_OTHER|||||||0.792|||||||ANOVA|||Between-groups comparison 2-way ANOVA BAI||||0.792
73872711|NCT02178995|147288313|SUPERIORITY_OR_OTHER|||||||0.045|||||||t-test, 2 sided|||AES visit 1 vs visit 5 epilepsy||||0.045
73872712|NCT02178995|147288313|SUPERIORITY_OR_OTHER|||||||0.646|||||||t-test, 2 sided|||AES visit 1 vs visit 5 healthy controls||||0.646
73872713|NCT02178995|147288313|SUPERIORITY_OR_OTHER|||||||0.222|||||||ANOVA|||Between-groups comparison 2-way ANOVA AES||||0.222
73872714|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.011|||||||t-test, 2 sided|||Health Perceptions||||0.011
73872715|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||Overall QOL (subjectively rated by participants on the scale)||||0.01
73872716|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.164|||||||t-test, 2 sided|||Physical Function||||0.164
73872717|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.065|||||||t-test, 2 sided|||Role Limitations (Emotional)||||0.065
73872718|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||Role Limitations (Physical)||||0.014
73980161|NCT00824850|147505631|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73872719|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.128|||||||t-test, 2 sided|||Pain||||0.128
73872720|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Work/Driving/Social||||0.026
73872721|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.077|||||||t-test, 2 sided|||Emotional Wellbeing||||0.077
73872722|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Health Discouragement||||0.007
73872723|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.063|||||||t-test, 2 sided|||Seizure Worry||||0.063
73872724|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.609|||||||t-test, 2 sided|||Medication Effects||||0.609
73872725|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.626|||||||t-test, 2 sided|||Social Support||||0.626
73872726|NCT02178995|147288314|SUPERIORITY_OR_OTHER|||||||0.103|||||||t-test, 2 sided|||Social Isolation||||0.103
73872727|NCT02178995|147288315|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Variability v1 vs v5 epilepsy||||<0.0001
73872728|NCT02178995|147288315|SUPERIORITY_OR_OTHER|||||||0.096|||||||t-test, 2 sided|||Variability v1 vs v5 healthy||||0.096
73872729|NCT02178995|147288315|SUPERIORITY_OR_OTHER|||||||0.136|||||||ANOVA|||Variability 2-way ANOVA healthy vs epilepsy||||0.136
73872730|NCT02178995|147288315|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||Perseverations v1 vs v5 epilepsy||||0.17
73872731|NCT02178995|147288315|SUPERIORITY_OR_OTHER|||||||0.104|||||||t-test, 2 sided|||Perseverations v1 vs v5 healthy||||0.104
73872732|NCT02178995|147288315|SUPERIORITY_OR_OTHER|||||||0.661|||||||ANOVA|||Perseverations 2-way ANOVA healthy vs epilepsy||||0.661
73872733|NCT02178995|147288316|SUPERIORITY_OR_OTHER|||||||0.397|||||||ANOVA|||Variability ANOVA||||0.397
73872734|NCT02178995|147288316|SUPERIORITY_OR_OTHER|||||||0.745|||||||ANOVA|||Perseverations ANOVA||||0.745
73872735|NCT02178995|147288316|SUPERIORITY_OR_OTHER|||||||0.362|||||||t-test, 2 sided|||10mg vs 20mg variability||||0.362
73872736|NCT02178995|147288316|SUPERIORITY_OR_OTHER|||||||0.745|||||||t-test, 2 sided|||10mg vs 20mg perseverations||||0.745
73872737|NCT02178995|147288317|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||HRT ANOVA||||0.48
73872738|NCT02178995|147288317|SUPERIORITY_OR_OTHER|||||||0.793|||||||t-test, 2 sided|||HRT 10mg vs 20mg||||0.793
73872739|NCT02178995|147288318|SUPERIORITY_OR_OTHER|||||||0.5|||||||t-test, 2 sided|||HRT v1 vs v5 epilepsy||||0.5
73872740|NCT02178995|147288318|SUPERIORITY_OR_OTHER|||||||0.075|||||||t-test, 2 sided|||HRT v1 vs v5 healthy||||0.075
73872741|NCT02178995|147288318|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|||HRT epilepsy vs healthy ANOVA||||0.2
73872742|NCT05258149|147288328|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.65|||||TWO_SIDED|95.0|1.1|2.46|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A|||2.46|1.10|
73872743|NCT05258149|147288329|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.27|2.79|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A|||2.79|1.27|
73872744|NCT05258149|147288330|NON_INFERIORITY|A Non-Inferiority margin of 10% was used.|Odds Ratio (OR)|0.74|||||TWO_SIDED|98.33|0.42|1.3|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|1.30|0.42|
73872745|NCT05258149|147288331|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.58|||||TWO_SIDED|98.33|0.91|2.75|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|2.75|0.91|
73872746|NCT05258149|147288332|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|2.08|||||TWO_SIDED|98.33|1.24|3.5|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|3.50|1.24|
73872747|NCT02859246|147288378|SUPERIORITY||||||<|0.04||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||||||<0.04
73872748|NCT02859246|147288379|SUPERIORITY||||||<|0.2||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||||||< 0.2
73872749|NCT05280717|147288386|OTHER||Ratio of geometric least square mean|0.9821|||||TWO_SIDED|90.0|0.8825|1.093|||||The ratio estimate and 90% confidence interval were obtained from an Analysis of covariance (ANCOVA) model, with AUC(D1- 29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.0930|0.8825|
73872750|NCT05280717|147288387|OTHER||Ratio of geometric least square mean|1.1258|||||TWO_SIDED|90.0|1.0108|1.2539|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.2539|1.0108|
73872751|NCT05280717|147288390|OTHER||Ratio of geometric least square mean|1.876|||||TWO_SIDED|90.0|1.6391|2.1472|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||2.1472|1.6391|
73872752|NCT05280717|147288390|OTHER||Ratio of geometric least square mean|1.5991|||||TWO_SIDED|90.0|1.4086|1.8153|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.8153|1.4086|
73872753|NCT05280717|147288391|OTHER||Ratio of geometric least square mean|2.0798|||||TWO_SIDED|90.0|1.8223|2.3737|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||2.3737|1.8223|
73872754|NCT05280717|147288391|OTHER||Ratio of geometric least square mean|1.6955|||||TWO_SIDED|90.0|1.4913|1.9276|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.9276|1.4913|
73872755|NCT05280717|147288396|OTHER||Ratio of geometric least square mean|0.9476|||||TWO_SIDED|90.0|0.8578|1.0469|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.0469|0.8578|
73872756|NCT05280717|147288396|OTHER||Ratio of geometric least square mean|1.5482|||||TWO_SIDED|90.0|1.377|1.7407|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.7407|1.3770|
73980162|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-10.2|
73872757|NCT05280717|147288396|OTHER||Ratio of geometric least square mean|1.4167|||||TWO_SIDED|90.0|1.2627|1.5894|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.5894|1.2627|
73872758|NCT00080301|147288404|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.0003||95.17|0.64|0.88||Test was stratified by 1) presence of visceral metastases in liver or lung, 2) minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse \> 6 months in adjuvant setting, and 3) prior chemotherapy for metastatic disease. (yes/no)|Log Rank|95.17% confidence interval is adjusted for the interim analysis.||Study required 615 events to achieve 90% power to detect a hazard ratio of 0.77 using a 2-sided α = 0.05 log-rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.0483 log-rank test (adjusted for an interim analysis using the O'Brien Fleming spending function) to reject the null hypothesis of equality of progression free survival. The analysis was conducted when 639 events (310 in combination:329 in capecitabine) were observed from the 752 randomized patients.||0.88|0.64|.0003
73872759|NCT00080301|147288405|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.15|||<|0.0001||95.0|2.2|4.5|||Cochran-Mantel-Haenszel|||The study had 95 percent power to detect a significant difference in ORR if the true response rate was 32 percent in the combination arm and 20 percent in the capecitabine arm.||4.50|2.20|<.0001
73980163|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
73872760|NCT00080301|147288408|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.1936||95.17|0.77|1.05||Test was stratified by presence of visceral metastases in liver or lung (y/n), minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse \> 6 months in adjuvant setting (y/n), and prior chemotherapy for metastatic disease (y/n).|Log Rank|Test was conducted at the α=0.05 level and no adjustments were performed.|Confidence Interval adjusted for interim analysis.|Study required 631 deaths to achieve 80% power to detect a Hazard ratio of 0.8 using a 2-sided α = 0.05 log rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.05 log-rank test to reject the null hypothesis of equality of survival. The analysis was conducted when 639 deaths (318 in combination:321 in capecitabine) were observed from the 752 randomized patients.||1.05|0.77|0.1936
73872761|NCT00080301|147288410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.||||.0002
73872762|NCT02518971|147288411|OTHER|||||||0.345|||||||Chi-squared|||||||0.345
73872763|NCT02518971|147288412|OTHER|||||||0.378|||||||Student T-Test|||||||.378
73872764|NCT02518971|147288413|OTHER|||||||1|||||||Fisher Exact|||||||1.0
73872765|NCT02518971|147288414|OTHER|||||||0.497|||||||Fisher Exact|||||||.497
73872766|NCT02518971|147288415|OTHER|||||||0.207|||||||Student T-test|||||||.207
73872767|NCT02336230|147288417|OTHER|||||||0.0003||||||P-value was calculated from the binomial distribution under the assumption of a 0.45 success rate for the null hypothesis.|Binomial Distribution|||||||0.0003
73872768|NCT02336230|147288419|OTHER|||||||0.0032||||||P-value was from a Cochran-Mantel-Haenszel (CMH) test stratified by baseline aGVHD grade.|CHM test|||||||0.0032
73872769|NCT02524171|147288423|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.1|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73872770|NCT02524171|147288423|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.88|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
73872771|NCT02524171|147288424|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73872772|NCT02524171|147288424|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
73872773|NCT02524171|147288425|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|10.98|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73872774|NCT02524171|147288425|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|14.64|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
73872775|NCT02524171|147288426|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|1.45|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews||||||>0.05
73872776|NCT02524171|147288426|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|1.22|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
73872777|NCT02524171|147288427|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.04|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73872778|NCT02524171|147288427|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
73872779|NCT02524171|147288428|SUPERIORITY||Time x Condition at 6mo.(Beta value)|0.04|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73980164|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73872780|NCT02524171|147288428|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
73872781|NCT02524171|147288429|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73872782|NCT02524171|147288429|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.08|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||<0.05
73872783|NCT02524171|147288430|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||<0.05
73872784|NCT02524171|147288430|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
73872785|NCT02524171|147288431|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta|0.69|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73872786|NCT02524171|147288431|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|-0.89|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
73872787|NCT02524171|147288432|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.07|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73872788|NCT02524171|147288432|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.01|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
73952830|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
73872789|NCT02524171|147288433|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|6.53|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73872790|NCT02524171|147288433|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|5.68|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63||||>0.05
73872791|NCT02524171|147288434|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.83|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73872792|NCT02524171|147288434|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.46|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.01
73872793|NCT02524171|147288435|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73980165|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73872794|NCT02524171|147288435|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)|-0.08|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
73872795|NCT02524171|147288436|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.03|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73872796|NCT02524171|147288436|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.07|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.05
73872797|NCT02524171|147288437|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.01|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
73872798|NCT02524171|147288437|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.08|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.05
73872799|NCT02524171|147288438|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.07|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||<0.05
73872800|NCT02524171|147288438|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.08|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
73872801|NCT00940901|147288439|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Null hypothesis: there would be no difference in the number of participants who experienced at least a 50% reduction in the frequency of priapic episodes between baseline and 8 weeks post intervention, between the sildenafil and placebo groups||||1
73872802|NCT00940901|147288440|SUPERIORITY_OR_OTHER|||||||0.55|||||||Fisher Exact|||||||0.55
73872803|NCT00757237|147288441|NON_INFERIORITY_OR_EQUIVALENCE|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-7.8||||0.0001|TWO_SIDED|95.0|-11.73|-3.86||Based on the Benjamini \& Hochberg method, non-inferiority at Day 28 for relative change in FEV1 percent predicted was assessed at the 0.05 level, given the significance of the coprimary endpoint (p\<0.05).|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use for all participants.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in the mean relative change of FEV1 percent predicted at Day 28. With 120 subjects per treatment group there was at least 85% power to declare noninferiority based on relative change from baseline at Day 28 in FEV1 percent predicted using the upper bound of a 2-tailed 95% CI for the difference in means with a noninferiority margin of 4, assuming a common standard deviation of 18% and true difference in means \[TIS-AZLI\] of -3.2%.||-3.86|-11.73|0.0001
73872804|NCT00757237|147288442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.0023||||||Based on the Benjamini \& Hochberg method, superiority at Weeks 4, 12, and 20 of actual change in FEV1 percent predicted was tested at the 0.05 level, given the significance of the coprimary endpoint (p\<0.05).|MMRM analysis|MMRM analysis included Day 0 FEV1 percent predicted, previous inhaled tobramycin use, treatment, visit, and treatment/visit interaction.|Treatment difference refers to TIS-AZLI.|"Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses among all participants.~With 120 subjects per treatment group, there was at least 90% power at a 5% significance level to detect differences based upon actual change from baseline in FEV1 percent predicted (3.61%, 2.98%, 2.32%) between AZLI and TIS at Weeks 4, 12, and 20 with a common standard deviation of 9%."||||0.0023
73952831|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.0||0.13|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.13
73980166|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980167|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
73872805|NCT00757237|147288443|NON_INFERIORITY_OR_EQUIVALENCE|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-9.5|||<|0.0001|TWO_SIDED|95.0|-13.86|-5.14||Secondary endpoints were tested sequentially by the closed testing procedure initiated by the significance of the primary endpoints. Given the coprimary endpoints were met at the 0.05 level, this non-inferiority endpoint was tested at the 0.05 level.|ANCOVA|ANCOVA model included treatment and Day 0 FEV1 percent predicted.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in terms of the participant means in relative change of FEV1 percent predicted at Day 28 among all participants having \>= 84 days of inhaled tobramycin use in the previous 12 months.||-5.14|-13.86|<0.0001
73872806|NCT00757237|147288444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.0002||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|MMRM analysis|MMRM analysis included treatment, Day 0 FEV1 percent predicted, visit, treatment, and treatment/visit interaction for all participants.|Treatment difference refers to TIS-AZLI|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses in the stratum of subjects having \>=84 days of inhaled tobramycin use in the previous 12 months.||||0.0002
73980168|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
73980169|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.7|15.3||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.3|-6.7|
73980170|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980171|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|0.9|||||TWO_SIDED|95.0|-15.0|17.6||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.6|-15.0|
73980172|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73980173|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
73980174|NCT00824850|147505632|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||7.6|-13.9|
73980175|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
73980176|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-10.2|
73980177|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73980178|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.5|
73980179|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
73980180|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|-2.8|||||TWO_SIDED|95.0|-16.8|10.1||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-16.8|
73980181|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||16.6|-9.1|
73980182|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-7.1|15.0||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.0|-7.1|
73980183|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
73980184|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|1.2|||||TWO_SIDED|95.0|-14.8|18.2||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||18.2|-14.8|
73980185|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980186|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-6.8|15.8||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.8|-6.8|
73872807|NCT00757237|147288445|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED|||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for IV antipseudomonal antibiotics for respiratory events.||||0.0025
73872808|NCT00757237|147288446|SUPERIORITY_OR_OTHER|||||||0.1114||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to first respiratory hospitalization.||||0.1114
73872809|NCT00757237|147288447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.61||||0.0048||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in change from baseline in CFQ-R RSS scores at Day 28.||||0.0048
73872810|NCT00757237|147288448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13||||0.0189||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the average actual change in respiratory symptoms at the end of each treatment course (Weeks 4, 12, and 20).||||0.0189
73872811|NCT00757237|147288449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.12||||0.0097||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the global satisfaction results of the TSQM at Week 20 (Day 140).||||0.0097
73872812|NCT00757237|147288450|SUPERIORITY_OR_OTHER|||||||0.044||||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory hospitalizations from Day 0 to Day 168 (end of study).||||0.044
73980187|NCT00824850|147505633|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||7.6|-13.9|
73980188|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|29.47|||||TWO_SIDED|95.0|17.61|49.33|||||Confidence intervals (CI) for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: Geometric mean fold rises (GMFRs) were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||49.33|17.61|
73980189|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.34|||||TWO_SIDED|95.0|8.49|15.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.13|8.49|
73872813|NCT00757237|147288451|SUPERIORITY_OR_OTHER|||||||0.004||0.0||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory events requiring IV and/or inhaled antipseudomonal antibiotics (other than randomized treatment) from Day 0 to Day 168 (end of study).||||0.004
73872814|NCT00757237|147288452|SUPERIORITY_OR_OTHER|||||||0.0004||||||No adjustments were made for multiple comparisons.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for inhaled and/or IV antipseudomonal antibiotics for respiratory events.||||0.0004
73872815|NCT01345188|147288453|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|||||||Paired t test|||||||0.058
73872816|NCT01345188|147288454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|||||||Paired t test|||||||0.048
73872817|NCT01345188|147288455|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Wilcoxon Signed rank|||||||>0.05
73872818|NCT01397461|147288502|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||"The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) and corresponding 95% asymptotic (Wald) CI for the difference in success rates for the ozenoxacin versus placebo were provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.~Text extracted from the statistical analysis plan. No additional data was pre-specified for the statistical comparison"||||0.003
73872819|NCT05729568|147288508|SUPERIORITY||Difference in least-squares means|-56.0||||0.1436|TWO_SIDED|95.0|-132.0|20.0|||ANCOVA||Difference in least-squares means (Diff in LSM), and its 95% CI were from ANCOVA model of change from baseline CD4 cell count with treatment as fixed effect and baseline CD4 cell count as a covariate.|||20|-132|0.1436
73872820|NCT04181762|147288521|SUPERIORITY||Mean Difference (Final Values)|-12.7||||0.0662|TWO_SIDED|95.0|-26.3|0.9|||Regression, Logistic||Difference from placebo and 95% CI are from a logistic regression model with treatment group, stratification factor (SoC) and race as factors and baseline UPCR as a covariate using marginal standardization method.|Complete Renal Response (CRR) at Week 52||0.9|-26.3|0.0662
73872821|NCT04181762|147288523|OTHER||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-23.7|8.4|||||95% Confidence Intervals (CIs) are constructed using the exact binomial test.|Partial Renal Response (PRR) at Week 52||8.4|-23.7|
73872822|NCT01147055|147288540|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|18.21|||||TWO_SIDED|90.0|16.14|20.54||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||20.54|16.14|
73872823|NCT01147055|147288541|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|31.49|||||TWO_SIDED|90.0|26.43|37.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||37.51|26.43|
73952832|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.0||0.047|TWO_SIDED|95.0|-8.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-8.0|0.047
73952833|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
73872824|NCT01147055|147288542|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|17.6|||||TWO_SIDED|90.0|15.48|20.02||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||20.02|15.48|
73872825|NCT01147055|147288547|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|5.49|||||TWO_SIDED|90.0|4.64|6.49||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||6.49|4.64|
73872826|NCT01147055|147288548|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|5.75|||||TWO_SIDED|90.0|4.86|6.81||||||Natural log transformed AUC (0 - ∞) of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||6.81|4.86|
73952834|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.34|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.34
73952835|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.46|TWO_SIDED|95.0|-6.0|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-6.0|0.46
73952836|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
73952837|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.2||0.03|TWO_SIDED|95.0|-9.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-9.0|0.030
73952838|NCT02886728|147439417|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-12.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-12.0|<0.001
73952839|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-10.78|STANDARD_ERROR_OF_MEAN|0.983|<|0.001|TWO_SIDED|95.0|-12.71|-8.85||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.85|-12.71|<0.001
73952840|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-8.76|STANDARD_ERROR_OF_MEAN|1.207|<|0.001|TWO_SIDED|95.0|-11.13|-6.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.39|-11.13|<0.001
73872827|NCT01147055|147288550|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|11.01|||||TWO_SIDED|90.0|9.02|13.45||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||13.45|9.02|
73872828|NCT05236257|147288557|OTHER||Hazard Ratio (HR)|0.21||||0.0058|TWO_SIDED|95.0|0.07|0.63|||Cox Proportional Hazards model|Unweighted||||0.63|0.07|0.0058
73872829|NCT05236257|147288557|OTHER|||||||0.0023|||||||Log Rank|Unweighted||||||0.0023
73872830|NCT05236257|147288558|OTHER||Hazard Ratio (HR)|0.23||||0.0703|TWO_SIDED|95.0|0.05|1.13|||Cox Proportional Hazards model|Unweighted||||1.13|0.05|0.0703
73952841|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-9.64|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-12.0|-7.29||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.29|-12.00|<0.001
73952842|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-9.92|STANDARD_ERROR_OF_MEAN|0.884|<|0.001|TWO_SIDED|95.0|-11.65|-8.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.19|-11.65|<0.001
73952843|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-8.34|STANDARD_ERROR_OF_MEAN|1.086|<|0.001|TWO_SIDED|95.0|-10.47|-6.21||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.21|-10.47|<0.001
73952844|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|-9.45|-5.21||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.21|-9.45|<0.001
73952845|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-5.98|STANDARD_ERROR_OF_MEAN|0.808|<|0.001|TWO_SIDED|95.0|-7.56|-4.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.39|-7.56|<0.001
73952846|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|0.987|<|0.001|TWO_SIDED|95.0|-6.14|-2.27||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.27|-6.14|<0.001
73952847|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-4.34|STANDARD_ERROR_OF_MEAN|0.993|<|0.001|TWO_SIDED|95.0|-6.29|-2.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.39|-6.29|<0.001
73952848|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-5.27|STANDARD_ERROR_OF_MEAN|1.003|<|0.001|TWO_SIDED|95.0|-7.24|-3.31||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.31|-7.24|<0.001
73872831|NCT05236257|147288558|OTHER|||||||0.0486|||||||Log Rank|Unweighted||||||0.0486
73872832|NCT05236257|147288559|OTHER||Hazard Ratio (HR)|0.23||||0.696|TWO_SIDED|95.0|0.05|1.12|||Cox Proportional Hazards model|Unweighted||||1.12|0.05|0.696
73872833|NCT05236257|147288559|OTHER|||||||0.0476|||||||Log Rank|Unweighted||||||0.0476
73872834|NCT05236257|147288561|OTHER||Hazard Ratio (HR)|0.79||||0.5713|TWO_SIDED|95.0|0.36|1.77|||Cox Proportional Hazards model|Unweighted||||1.77|0.36|0.5713
73872835|NCT05236257|147288561|OTHER|||||||0.5695|||||||Log Rank|Unweighted||||||0.5695
73872836|NCT05236257|147288562|OTHER||Hazard Ratio (HR)|0.32||||0.32|TWO_SIDED|95.0|0.03|3.06|||Cox Proportional Hazards model|Unweighted||||3.06|0.03|0.3200
73872837|NCT05236257|147288562|OTHER|||||||0.294|||||||Log Rank|Unweighted||||||0.2940
73872838|NCT00874848|147288568|SUPERIORITY_OR_OTHER|||||||0.2895|||||||Fisher Exact|||||||0.2895
73872839|NCT03559933|147288574|SUPERIORITY||Logistic regression model|95.0|STANDARD_ERROR_OF_MEAN|0.0152||0.0125|TWO_SIDED|95.0|93.15|96.66|||Mixed Models Analysis|Subject and stimulation within subject as random effects with multiple observations per subject was accounted for.||The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects with multiple observations per subject. The null hypothesis was tested comparing the lower bound of the 98.75% two-sided confidence interval for the estimated percent diaphragm capture rate to the performance goal of 80%. If the lower bound was greater than 80%, the null hypothesis was rejected, and the endpoint was considered met.||96.66|93.15|0.0125
73872840|NCT00412893|147288609|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper bound of the 95% CI for the treatment difference was compared to the protocol prespecified non-inferiority margin of 10%. If the upper bound was smaller than 10%, isavuconazole was declared as non-inferior to voriconazole with respect to the primary outcome measure.|Adjusted Treatment Difference|-1.0|||||TWO_SIDED|95.0|-7.759|5.683|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Approximately 255 patients per group were to be enrolled to ensure at least 80% power to demonstrate that the upper bound of the 95% confidence interval (CI) for a treatment difference in favor of the comparator was no larger than 10%.||5.683|-7.759|
73952849|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-3.29|STANDARD_ERROR_OF_MEAN|1.222||0.007|TWO_SIDED|95.0|-5.68|-0.89||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.89|-5.68|0.007
73952850|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-4.61|STANDARD_ERROR_OF_MEAN|1.229|<|0.001|TWO_SIDED|95.0|-7.02|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.20|-7.02|<0.001
74033014|NCT05281523|147619011|OTHER|The pooled statistical analyses was performed using a Mixed Models Repeated Measures (MMRM) model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, study, visit and interaction terms for visit by baseline score and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.75||||0.004|TWO_SIDED|95.0|-1.26|-0.25|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis).||-0.25|-1.26|0.004
73872841|NCT00412893|147288610|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|1.6|||||TWO_SIDED|95.0|-9.336|12.572|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||12.572|-9.336|
73952851|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-3.44|STANDARD_ERROR_OF_MEAN|0.974|<|0.001|TWO_SIDED|95.0|-5.35|-1.53||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.53|-5.35|<0.001
73952852|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.72|-1.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.09|-5.72|0.004
73952853|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-2.12|STANDARD_ERROR_OF_MEAN|1.18||0.072|TWO_SIDED|95.0|-4.44|0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.19|-4.44|0.072
73952854|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-4.79|STANDARD_ERROR_OF_MEAN|0.789|<|0.001|TWO_SIDED|95.0|-6.34|-3.24||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.24|-6.34|<0.001
73952855|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-3.01|STANDARD_ERROR_OF_MEAN|0.957||0.002|TWO_SIDED|95.0|-4.88|-1.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.13|-4.88|0.002
74033015|NCT05299983|147619030|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<.001
74033016|NCT05299983|147619031|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
74033017|NCT05299983|147619032|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
74033018|NCT05299983|147619033|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
73872842|NCT00412893|147288610|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-0.5|||||TWO_SIDED|95.0|-11.277|10.329|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||10.329|-11.277|
73872843|NCT00412893|147288610|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|8.2|||||TWO_SIDED|95.0|-1.993|18.379|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||18.379|-1.993|
73872844|NCT00412893|147288611|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-1.4|||||TWO_SIDED|95.0|-9.15|6.34|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.|||6.340|-9.150|
73872845|NCT00412893|147288613|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|0.4|||||TWO_SIDED|95.0|-10.64|11.531|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment Comparison||11.531|-10.640|
73872846|NCT00412893|147288613|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-5.8|||||TWO_SIDED|95.0|-17.368|5.802|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||5.802|-17.368|
73872847|NCT00412893|147288613|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|0.3|||||TWO_SIDED|95.0|-11.116|11.758|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||11.758|-11.116|
73872848|NCT00412893|147288614|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|3.8|||||TWO_SIDED|95.0|-7.429|15.087|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||15.087|-7.429|
73872849|NCT00412893|147288614|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-0.7|||||TWO_SIDED|95.0|-11.917|10.586|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 Comparison||10.586|-11.917|
73872850|NCT00412893|147288614|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|9.1|||||TWO_SIDED|95.0|-1.624|19.83|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 Comparison||19.830|-1.624|
73872851|NCT00412893|147288615|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.7|||||TWO_SIDED|95.0|-4.936|16.268|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||16.268|-4.936|
73872852|NCT00412893|147288615|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.3|||||TWO_SIDED|95.0|-5.338|16.032|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||16.032|-5.338|
73872853|NCT00412893|147288615|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|9.0|||||TWO_SIDED|95.0|-1.231|19.186|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||19.186|-1.231|
73872854|NCT00412893|147288616|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.0|||||TWO_SIDED|95.0|-6.043|16.026|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||16.026|-6.043|
73872855|NCT00412893|147288616|SUPERIORITY_OR_OTHER_LEGACY||Adjusted treatment Difference|0.2|||||TWO_SIDED|95.0|-10.873|11.22|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||11.220|-10.873|
73872856|NCT00412893|147288616|SUPERIORITY_OR_OTHER_LEGACY||Adjusted treatment Difference|4.7|||||TWO_SIDED|95.0|-6.533|15.939|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||15.939|-6.533|
73872857|NCT00412893|147288617|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|4.4|||||TWO_SIDED|95.0|-8.429|17.218|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||17.218|-8.429|
73872858|NCT00412893|147288617|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-2.5|||||TWO_SIDED|95.0|-15.071|10.073|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||10.073|-15.071|
73872859|NCT00412893|147288617|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|2.9|||||TWO_SIDED|95.0|-8.633|14.499|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||14.499|-8.633|
73872860|NCT00412893|147288618|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|6.3|||||TWO_SIDED|95.0|-5.145|17.696|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||17.696|-5.145|
74033019|NCT00074412|147619059|SUPERIORITY_OR_OTHER_LEGACY||6 month Rate of Cum. HIV Infection (%)|1.1|||||TWO_SIDED|95.0|0.3|1.8|||Kaplan-Meier Method|||||1.8|0.3|
73872861|NCT00412893|147288618|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|8.0|||||TWO_SIDED|95.0|-3.335|19.356|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||19.356|-3.335|
73872862|NCT00412893|147288618|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.1|||||TWO_SIDED|95.0|-6.187|16.332|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||16.332|-6.187|
73872863|NCT04473963|147288624|NON_INFERIORITY|Non-inferiority between subjects Randomized to Treatment vs subjects Randomized to Control||||||0.277|||||||Chi-squared|||||||0.277
73872864|NCT04473963|147288626|EQUIVALENCE|"Equivalence between subjects Randomized to Control and subjects Randomized to Treatment"||||||0.042|||||||Kaplan-Meyer Log Rank|||||||0.042
73872865|NCT04473963|147288631|EQUIVALENCE|"Equivalence between procedure time of subjects Randomized to Treatment and subjects Randomized to Control. The Not-Randomized group was not included in the analysis."|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73952856|NCT02886728|147439418|SUPERIORITY||Least Squares Mean Difference|-3.77|STANDARD_ERROR_OF_MEAN|0.957|<|0.001|TWO_SIDED|95.0|-5.65|-1.89||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.89|-5.65|<0.001
73872866|NCT00587158|147288639|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Fisher Exact|||||||0.0005
73872867|NCT00587158|147288640|SUPERIORITY_OR_OTHER|||||||0.4571||95.0|||||Fisher Exact|||||||0.4571
73872868|NCT00587158|147288641|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Fisher Exact|||||||0.2290
73872869|NCT00587158|147288642|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at baseline was compared between the two treatment groups.||||0.17
73872870|NCT00587158|147288642|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at 21 days was compared between the two treatment groups.||||0.005
73872871|NCT00587158|147288642|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at 90 days was compared between the two treatment groups.||||<0.0001
73872872|NCT00587158|147288642|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at one year was compared between the two treatment groups.||||0.0004
73872873|NCT00587158|147288643|SUPERIORITY_OR_OTHER|||||||0.833||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at baseline was compared between the two treatment groups.||||0.833
73872874|NCT00587158|147288643|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at 21 days was compared between the two treatment groups.||||0.553
73872875|NCT00587158|147288643|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at 90 days was compared between the two treatment groups.||||0.035
73872876|NCT00587158|147288643|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at one year was compared between the two treatment groups.||||0.171
73872877|NCT00587158|147288644|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||t-test, 2 sided|||||||0.98
73952857|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|19.7|||<|0.001|TWO_SIDED|95.0|12.8|26.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||26.7|12.8|<0.001
73872878|NCT00587158|147288645|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||||||0.41
73872879|NCT00587158|147288648|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
73872880|NCT00587158|147288649|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
73872881|NCT00587158|147288650|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
73872882|NCT00587158|147288651|SUPERIORITY_OR_OTHER|||||||1||95.0|||||t-test, 2 sided|||The number of subjects with mild interstitial fibrosis (Banff ci score \> 0 and \< 2) at one year was compared between treatment groups.||||1.0
73872883|NCT00587158|147288651|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||The number of subjects with moderate to mild interstitial fibrosis (Banff ci score greater than or equal to 2) at one year was compared between treatment groups.||||0.04
73872884|NCT02114606|147288653|OTHER|Overall agreement was calculated using Cohen's Kappa, with endoscopic biopsy as the gold standard.||||||0.0001||||||A p-value of \<0.05 was considered statistically significant.|Cohen's Kappa|||All participants enrolled (EoE Patients) provided both a Cytosponge specimen and endoscopic biopsy. The results of these specimens were compared to examine overall agreement.||||0.0001
73952858|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|7.6|25.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||25.0|7.6|<0.001
74033020|NCT00074412|147619059|SUPERIORITY_OR_OTHER_LEGACY||6 month Rate of Cum. HIV Infection (%)|2.4|||||TWO_SIDED|95.0|1.3|3.6|||Kaplan-Meier Method|||||3.6|1.3|
73872885|NCT03187119|147288658|SUPERIORITY||Slope|1.41||||0.42|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|linear mixed model|||The reference group for this model is the Pictorial Asthma Action Plan Group.||||0.42
73872886|NCT03187119|147288658|SUPERIORITY||Slope|-14.31||||0.03|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
73872887|NCT03187119|147288658|SUPERIORITY||Slope|-0.33||||0.89|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.89
73872888|NCT03187119|147288659|SUPERIORITY||Slope|-1.59||||0.31|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.31
73872889|NCT03187119|147288659|SUPERIORITY||Slope|1.9||||0.73|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.73
73980190|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.58|||||TWO_SIDED|95.0|4.06|7.67|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.67|4.06|
73980191|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|71.09|||||TWO_SIDED|95.0|40.74|124.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||124.08|40.74|
73872890|NCT03187119|147288659|SUPERIORITY||Slope|-0.21||||0.92|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.92
73872891|NCT03187119|147288660|SUPERIORITY||Slope|0.52||||0.06|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.06
73980192|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.91|||||TWO_SIDED|95.0|4.92|12.73|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.73|4.92|
74033021|NCT00074412|147619059|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.973||||0.049||95.0||||P-value has not been adjusted for interim analysis or multiple testing. A priori threshold for statistical significance was 0.05.|Z-test|||Assuming the cumulative HIV infection rate in placebo group would be 4.2% (2.6 at 6 wk. \& 6.7 at 6 mon.), we estimated 1500 mother/infant pairs would provide 90% power to detect a reduction in HIV infection from 4.2% to 1.4% at 6 mon. with a Pearson χ² test statistic and a one-sided false positive error rate of 0.025. Rate of cumulative infection was calculated using Kaplan-Meier method and rates between extended NVP group and placebo were done with the Z statistic.||||0.049
74033022|NCT00074412|147619061|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 6mon (%)|97.7|||||TWO_SIDED|95.0|96.6|98.8|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 6 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.||98.8|96.6|
73872892|NCT03187119|147288660|SUPERIORITY||Slope|-1.57||||0.07|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 2 for the main effect of group and the time x group interaction.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.07
73872893|NCT03187119|147288660|SUPERIORITY||Slope|0.37||||0.33|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 2 and 3 for the main effects of group and time.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.33
73872894|NCT03187119|147288661|SUPERIORITY||Slope|-0.01||||0.002|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2-3 for the main effects of time and prescription and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||.002
73872895|NCT03187119|147288661|SUPERIORITY||Slope|-0.16||||0.07|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effects of time and prescription and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.07
73872896|NCT03187119|147288661|SUPERIORITY||Slope|0.43||||0.69|TWO_SIDED|||||The results listed here are for the main effect of prescription. Please see Analyses 1-2 for the main effects of time and group and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||.69
73872897|NCT03187119|147288661|SUPERIORITY||Slope|0.02||||0.37|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 5-7 for other interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.37
74033023|NCT00074412|147619061|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 6mon (%)|96.8|||||TWO_SIDED|95.0|95.5|98.0|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 6 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.||98.0|95.5|
73872898|NCT03187119|147288661|SUPERIORITY||Slope|-1.14||||0.12|TWO_SIDED|||||The results listed here are for the prescription x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4 and 6 for other interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.12
73872899|NCT03187119|147288661|SUPERIORITY||Slope|0.01||||0.006|TWO_SIDED|||||The results listed here are for the time x PAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference groups for this analysis is the 2x per day group.||||0.006
73872900|NCT03187119|147288661|SUPERIORITY||Slope|0.04||||0.006|TWO_SIDED|||||The results listed here are for the time x WAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions.|generalized linear mixed model||These analyses are modeling lower adherence.|The reference group for this analysis is 2x per day group.||||0.006
73872901|NCT03187119|147288662|SUPERIORITY||Slope|0.08||||0.18|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.18
73872902|NCT03187119|147288662|SUPERIORITY||Slope|-0.09||||0.71|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.71
73980193|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.56|||||TWO_SIDED|95.0|2.87|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.26|2.87|
74033024|NCT00074412|147619061|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.095||||0.274||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 6 months were compared between the two groups using a Z-statistic.||||0.274
73872903|NCT03187119|147288662|SUPERIORITY||Slope|0.007||||0.96|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.96
73872904|NCT03187119|147288664|SUPERIORITY||Slope|-0.02||||0.74|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.74
73872905|NCT03187119|147288664|SUPERIORITY||Slope|0.02||||0.83|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.83
73872906|NCT03187119|147288664|SUPERIORITY||Slope|-0.21||||0.03|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
73872907|NCT03187119|147288665|SUPERIORITY||Slope|0.12||||0.08|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.08
73872908|NCT03187119|147288665|SUPERIORITY||Slope|-0.12||||0.25|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.25
73872909|NCT03187119|147288665|SUPERIORITY||Slope|-0.21||||0.03|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
73872910|NCT01910402|147288678|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hypothesis was to show that the antiviral effect of the DTG/ABC/3TC FDC administered QD was non-inferior to QD ATV+RTV+TDF/FTC FDC. Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -12%|Adjusted difference in proportion|10.5||||0.005|TWO_SIDED|95.0|3.1|17.8||If the primary and PP analyses both demonstrated non-inferiority, then as per pre-specified analysis, superiority of DTG/ABC/3TC FDC versus ATV+RTV+TDF/FTC FDC was tested in the ITT-E population at the 2-sided 5% level of significance.|Cochran-Mantel-Haenszel|||||17.8|3.1|0.005
73872911|NCT01910402|147288700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026||||0.7053|TWO_SIDED|95.0|-0.159|0.107|||Multiple Imputed Dataset - MAR|||||0.107|-0.159|0.7053
73872912|NCT01910402|147288701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.106||||0.3165|TWO_SIDED|95.0|-0.313|0.101|||Multiple Imputed Dataset - MAR|||||0.101|-0.313|0.3165
73872913|NCT01910402|147288716|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.729|||<|0.001|TWO_SIDED|95.0|0.683|0.779|||ANCOVA||BSAP ratio of Week 48 result over Baseline|||0.779|0.683|<0.001
73872914|NCT01910402|147288716|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.693|||<|0.001|TWO_SIDED|95.0|0.647|0.741|||ANCOVA||PTP ratio of Week 48 result over Baseline|||0.741|0.647|<0.001
74033025|NCT00074412|147619061|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 18mon (%)|94.5|||||TWO_SIDED|95.0|92.9|96.2|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while 95% confidence intervals were calculated using Greenwood's formula.||96.2|92.9|
74033026|NCT00074412|147619061|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 18mon (%)|93.3|||||TWO_SIDED|95.0|91.5|95.1|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||95.1|91.5|
73872915|NCT01910402|147288716|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.629|||<|0.001|TWO_SIDED|95.0|0.581|0.68|||ANCOVA||Osteocalcin ratio of Week 48 result over Baseline|||0.680|0.581|<0.001
73980194|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.85|||||TWO_SIDED|95.0|4.51|10.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.42|4.51|
73872916|NCT01910402|147288716|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.655|||<|0.0001|TWO_SIDED|95.0|0.609|0.706|||ANCOVA||Type 1 Collagen C-Telopeptide ratio of Week 48 result over Baseline|||0.706|0.609|<0.0001
73872917|NCT01910402|147288716|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.852|||<|0.0001|TWO_SIDED|95.0|0.794|0.914|||ANCOVA||Vitamin D ratio of Week 48 result over Baseline|||0.914|0.794|<0.0001
73872918|NCT01910402|147288718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0||||Week 4|Wilcoxon (Mann-Whitney)|||||||0.016
73872919|NCT01910402|147288718|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Week 12|Wilcoxon (Mann-Whitney)|||||||<0.001
73872920|NCT01910402|147288718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Week 24|Wilcoxon (Mann-Whitney)|||||||0.002
73872921|NCT01910402|147288718|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||Week 48|Wilcoxon (Mann-Whitney)|||||||0.007
73872922|NCT01466127|147288724|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
73872923|NCT00571038|147288729|SUPERIORITY_OR_OTHER|||||||0.2417|TWO_SIDED||||||Mixed Models Analysis|||||||0.2417
73872924|NCT00571038|147288730|SUPERIORITY_OR_OTHER|||||||0.8586|TWO_SIDED||||||Mixed Models Analysis|||||||0.8586
73872925|NCT00571038|147288731|SUPERIORITY_OR_OTHER|||||||0.0432|TWO_SIDED||||||Mixed Models Analysis|||||||0.0432
73872926|NCT00571038|147288732|SUPERIORITY_OR_OTHER|||||||0.0604|TWO_SIDED||||||Mixed Models Analysis|||||||0.0604
73872927|NCT00571038|147288733|SUPERIORITY_OR_OTHER|||||||0.0438|TWO_SIDED||||||Kruskal-Wallis|||||||0.0438
73872928|NCT00571038|147288734|SUPERIORITY_OR_OTHER|||||||0.1418|TWO_SIDED||||||Kruskal-Wallis|||||||0.1418
73872929|NCT00571038|147288735|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|Two-sided Pr \<= P||||||0.0070
73872930|NCT00571038|147288736|SUPERIORITY_OR_OTHER|||||||0.8395|TWO_SIDED||||||Kruskal-Wallis|||||||0.8395
73872931|NCT00571038|147288737|SUPERIORITY_OR_OTHER|||||||0.2194|TWO_SIDED||||||Kruskal-Wallis|||||||0.2194
73872932|NCT00571038|147288738|SUPERIORITY_OR_OTHER|||||||0.9191|TWO_SIDED||||||Kruskal-Wallis|||||||0.9191
73872933|NCT00571038|147288739|SUPERIORITY_OR_OTHER|||||||0.9633|TWO_SIDED||||||Kruskal-Wallis|||||||0.9633
73872934|NCT00571038|147288740|SUPERIORITY_OR_OTHER|||||||0.5901|TWO_SIDED||||||Kruskal-Wallis|||||||0.5901
73872935|NCT00571038|147288741|SUPERIORITY_OR_OTHER|||||||0.982|TWO_SIDED||||||Kruskal-Wallis|||||||0.9820
73872936|NCT00571038|147288742|SUPERIORITY_OR_OTHER|||||||0.3979|TWO_SIDED||||||Kruskal-Wallis|||||||0.3979
73872937|NCT00571038|147288743|SUPERIORITY_OR_OTHER|||||||0.1471|TWO_SIDED||||||Kruskal-Wallis|||||||0.1471
73872938|NCT00571038|147288744|SUPERIORITY_OR_OTHER|||||||0.6123|TWO_SIDED||||||Kruskal-Wallis|||||||0.6123
73872939|NCT00571038|147288745|SUPERIORITY_OR_OTHER|||||||0.5861|TWO_SIDED||||||Kruskal-Wallis|||||||0.5861
73872940|NCT00571038|147288746|SUPERIORITY_OR_OTHER|||||||0.4489|TWO_SIDED||||||Kruskal-Wallis|||||||0.4489
73872941|NCT00571038|147288747|SUPERIORITY_OR_OTHER|||||||0.2527|TWO_SIDED||||||Kruskal-Wallis|||||||0.2527
73872942|NCT00571038|147288748|SUPERIORITY_OR_OTHER|||||||0.7314|TWO_SIDED||||||Kruskal-Wallis|||||||0.7314
73872943|NCT00571038|147288749|SUPERIORITY_OR_OTHER|||||||0.9839|TWO_SIDED||||||Kruskal-Wallis|||||||0.9839
73872944|NCT00413218|147288758|NON_INFERIORITY|The lower bound of the 95% CI for the adjusted treatment difference was compared to the protocol prespecified noninferiority margin (NIM) value of -15%. If the lower bound were greater than -15%, isavuconazole would be declared as noninferior to caspofungin.|Adjusted Treatment Difference (%)|-10.8|||||TWO_SIDED|95.0|-19.9|-1.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified Cochran-Mantel-Haenszel (CMH) method with the strata of geographical region and baseline neutropenic status.||-1.8|-19.9|
74033027|NCT00074412|147619061|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|0.988||||0.323||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 18 months were compared between the two groups using a Z statistic.||||0.323
73872945|NCT00413218|147288759|OTHER||Adjusted Treatment Difference (%)|-2.7|||||TWO_SIDED|95.0|-12.2|6.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||6.8|-12.2|
73872946|NCT00413218|147288760|OTHER||Adjusted Treatment Difference %|-10.9|||||TWO_SIDED|95.0|-19.9|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.9|-19.9|
73872947|NCT00413218|147288760|OTHER||Adjusted Treatment Difference %|-5.4|||||TWO_SIDED|95.0|-15.0|4.2|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||4.2|-15.00|
73872948|NCT00413218|147288761|OTHER||Adjusted Treatment Difference (%)|-8.2|||||TWO_SIDED|95.0|-15.4|-0.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-0.9|-15.4|
73872949|NCT00413218|147288761|OTHER||Adjusted Treatment Difference (%)|-8.6|||||TWO_SIDED|95.0|-15.8|-1.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.5|-15.8|
73872950|NCT00413218|147288761|OTHER||Adjusted Treatment Difference (%)|-0.4|||||TWO_SIDED|95.0|-9.1|8.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||8.3|-9.1|
73980195|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|6.98|17.64|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||17.64|6.98|
73980196|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.68|||||TWO_SIDED|95.0|1.37|2.07|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.07|1.37|
73980197|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.52|2.9|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.90|1.52|
73980198|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.7|||||TWO_SIDED|95.0|4.77|12.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.42|4.77|
73980199|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.2|||||TWO_SIDED|95.0|4.95|10.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.48|4.95|
73980200|NCT00824850|147505634|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.02|||||TWO_SIDED|95.0|2.23|4.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.10|2.23|
73980201|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|19.68|||||TWO_SIDED|95.0|9.99|38.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||38.77|9.99|
73980202|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.7|||||TWO_SIDED|95.0|3.9|8.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||8.33|3.90|
73980203|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.78|||||TWO_SIDED|95.0|2.16|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.57|2.16|
73980204|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|23.46|||||TWO_SIDED|95.0|13.17|41.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||41.79|13.17|
73980205|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|13.68|||||TWO_SIDED|95.0|8.94|20.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||20.92|8.94|
73980206|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.98|||||TWO_SIDED|95.0|6.21|12.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.97|6.21|
74033028|NCT00074412|147619062|SUPERIORITY_OR_OTHER_LEGACY||18 mon. Rate of Cum HIV Infection (%)|2.2|||||TWO_SIDED|95.0|1.1|3.3|||Kaplan-Meier Method|||The cumulative rate of HIV infection at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||3.3|1.1|
73872951|NCT00413218|147288761|OTHER||Adjusted Treatment Difference (%)|-5.8|||||TWO_SIDED|95.0|-15.3|3.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||3.6|-15.3|
73872952|NCT00413218|147288762|OTHER||Adjusted Treatment Difference (%)|-14.9|||||TWO_SIDED|95.0|-22.7|-7.0|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-7.0|-22.7|
73872953|NCT00413218|147288762|OTHER||Adjusted Treatment Difference (%)|-15.9|||||TWO_SIDED|95.0|-23.5|-8.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-8.4|-23.5|
73872954|NCT00413218|147288762|OTHER||Adjusted Treatment Difference (%)|-0.7|||||TWO_SIDED|95.0|-8.1|9.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||9.6|-8.1|
73872955|NCT00413218|147288762|OTHER||Adjusted Treatment Difference (%)|-5.2|||||TWO_SIDED|95.0|-14.7|4.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||4.3|-14.7|
73872956|NCT00413218|147288763|OTHER||Adjusted Treatment Difference (%)|-11.4|||||TWO_SIDED|95.0|-20.4|-2.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-2.5|-20.4|
73872957|NCT00413218|147288763|OTHER||Adjusted Treatment Difference (%)|-8.5|||||TWO_SIDED|95.0|-16.5|-0.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-0.4|-16.5|
73872958|NCT00413218|147288764|OTHER||Adjusted Treatment Difference (%)|-11.1|||||TWO_SIDED|95.0|-20.3|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.9|-20.3|
73872959|NCT00413218|147288764|OTHER||Adjusted Treatment Difference (%)|-8.1|||||TWO_SIDED|95.0|-16.3|0.1|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||0.1|-16.3|
73872960|NCT00413218|147288765|OTHER||Adjusted Treatment Difference (%)|2.5|||||TWO_SIDED|95.0|-3.8|8.9||||||Statistical analysis of all-cause mortality on Day 14. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.||8.9|-3.8|
73872961|NCT00413218|147288765|OTHER||Adjusted Treatment Difference (%)|1.4|||||TWO_SIDED|95.0|-7.1|10.0||||||Statistical analysis of all-cause mortality on Day 56. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.||10.0|-7.1|
73872962|NCT01687296|147288799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.46||||0.931|TWO_SIDED|95.0|-9.85|10.76|||ANCOVA|||250 par were to be enrolled to achieve 200 total evaluable par or 100 evaluable par per group. Sample size was based on the primary efficacy endpoint (AM PEF) and had 80% power to reject the null hypothesis: nebulized FP (1 mg BID) was inferior to oral prednisone with regard to AM PEF using one-side t test at significance level 2.5%, and assuming true treatment difference (FP minus predisone) was 3.6 L/min, noninferiority margin was -12L/min, and common standard deviation was 39 L/min.||10.76|-9.85|0.931
73872963|NCT01687296|147288800|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.5||||0.922|TWO_SIDED|95.0|-9.64|10.65|||ANCOVA|||||10.65|-9.64|0.922
73872964|NCT01687296|147288801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.822|TWO_SIDED|95.0|-9.02|11.34|||ANCOVA|||||11.34|-9.02|0.822
73872965|NCT01687296|147288802|SUPERIORITY_OR_OTHER|||||||0.717||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for day-time symptom score||||0.717
73872966|NCT01687296|147288802|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for night-time symptom score||||0.683
73872967|NCT01687296|147288803|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Wilcoxon rank sum test|||||||0.996
73952859|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|11.7||||0.004|TWO_SIDED|95.0|3.0|20.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||20.4|3.0|0.004
73952860|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|18.5|||<|0.001|TWO_SIDED|95.0|11.7|25.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||25.2|11.7|<0.001
74089443|NCT02697773|147731641|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7475|TWO_SIDED|95.0|0.73|1.54|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.54|0.73|0.7475
73872968|NCT01687296|147288804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.348|TWO_SIDED|95.0|-0.135|0.048|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 5||0.048|-0.135|0.348
73980207|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.0|||||TWO_SIDED|95.0|5.91|13.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||13.72|5.91|
73980208|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.58|||||TWO_SIDED|95.0|5.36|10.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.72|5.36|
73980209|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.56|||||TWO_SIDED|95.0|1.3|1.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.86|1.30|
73980210|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.93|||||TWO_SIDED|95.0|1.43|2.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.60|1.43|
73980211|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.46|||||TWO_SIDED|95.0|3.09|6.45|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.45|3.09|
73980212|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.32|||||TWO_SIDED|95.0|3.65|7.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.75|3.65|
73980213|NCT00824850|147505635|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.27|||||TWO_SIDED|95.0|2.49|4.28|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.28|2.49|
73980214|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|15.86|||||TWO_SIDED|95.0|9.16|27.46|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||27.46|9.16|
73980215|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.01|||||TWO_SIDED|95.0|3.5|7.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.16|3.50|
73980216|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.86|||||TWO_SIDED|95.0|2.93|5.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.09|2.93|
74089444|NCT02697773|147731641|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6564|TWO_SIDED|95.0|0.63|1.33|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.33|0.63|0.6564
73872969|NCT01687296|147288804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004||||0.914|TWO_SIDED|95.0|-0.074|0.083|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 8||0.083|-0.074|0.914
73872970|NCT01687296|147288804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.067||||0.276|TWO_SIDED|95.0|-0.187|0.054|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 5||0.054|-0.187|0.276
73872971|NCT01687296|147288804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.384|TWO_SIDED|95.0|-0.126|0.049|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 8||0.049|-0.126|0.384
74089445|NCT02697773|147731643|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.11||0.4833|TWO_SIDED|95.0|0.73|1.16|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.16|0.73|0.4833
73872972|NCT01687296|147288805|SUPERIORITY_OR_OTHER|||||||0.507||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 5||||0.507
73872973|NCT01687296|147288805|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 8||||0.700
73872974|NCT01687296|147288806|SUPERIORITY_OR_OTHER|||||||0.633||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for participant/parent global evaluation||||0.633
73872975|NCT01687296|147288806|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for investigator global evaluation||||0.323
73872976|NCT01219985|147288853|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||We performed a McNemar test to compare the sensitivities obtained for each PET image method||||<0.001
73952861|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|7.1||||0.083|TWO_SIDED|95.0|-1.6|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||15.8|-1.6|0.083
73952862|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|6.4|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||23.1|6.4|<0.001
73872977|NCT01219985|147288854|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis was : lesions' SUVmax are equivalent with our without application of the CT-Based respiratory-gated PET method.||||<0.001
73872978|NCT04797780|147288855|SUPERIORITY||Difference in CR Rate|5.06||||0.2084|TWO_SIDED|95.0|-7.1|17.2|||Cochran-Mantel-Haenszel|||||17.2|-7.1|0.2084
73872979|NCT03071393|147288889|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73872980|NCT03071393|147288890|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73872981|NCT03071393|147288891|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73872982|NCT03071393|147288892|SUPERIORITY||||||<|0.05||||||Uncorrected p values are reported.|Wilcoxon (Mann-Whitney)|||||||<0.05
73872983|NCT02324816|147288899|OTHER||success proportion|73.7|||||TWO_SIDED|95.0|48.8|90.9||||||||90.9|48.8|
73872984|NCT05169424|147288900|OTHER|Comparison of Stiolto (reference group) versus Trelegy for incidence rate of exacerbation.|Hazard Ratio (HR)|1.133||||0.064|TWO_SIDED|95.0|0.993|1.293|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.293|0.993|0.064
73872985|NCT05169424|147288900|OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
73872986|NCT05169424|147288900|OTHER|||||||0.063|||||||Log Rank|||||||0.063
73872987|NCT05169424|147288901|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.169||||0.057|TWO_SIDED|95.0|0.996|1.372|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.372|0.996|0.057
73872988|NCT05169424|147288902|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.116||||0.114|TWO_SIDED|95.0|0.974|1.279|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.279|0.974|0.114
73872989|NCT05169424|147288903|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.374||||0.273|TWO_SIDED|95.0|0.779|2.424|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||2.424|0.779|0.273
73872990|NCT05169424|147288904|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.183||||0.429|TWO_SIDED|95.0|0.78|1.792|||Regression, Cox|||||1.792|0.780|0.429
73872991|NCT05169424|147288904|OTHER|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
73872992|NCT05169424|147288904|OTHER|||||||0.932|||||||Log Rank|||||||0.932
73872993|NCT05169424|147288905|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|0.979||||0.935|TWO_SIDED|95.0|0.582|1.645|||Regression, Cox|||||1.645|0.582|0.935
73872994|NCT05169424|147288906|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.159||||0.507|TWO_SIDED|95.0|0.75|1.79|||Regression, Cox|||||1.790|0.750|0.507
73872995|NCT05169424|147288907|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.291||||0.726|TWO_SIDED|95.0|0.309|5.405|||Regression, Cox|||||5.405|0.309|0.726
73872996|NCT05169424|147288908|OTHER|||||||0.874|||||||t-test, 2 sided|||||||0.874
73872997|NCT05169424|147288908|OTHER||Exponential estimate|0.895||||0.01|TWO_SIDED|95.0|0.823|0.974|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||0.974|0.823|0.01
73872998|NCT05169424|147288909|OTHER|||||||0.899|||||||t-test, 2 sided|||||||0.899
73872999|NCT05169424|147288909|OTHER||Exponential estimate|0.897||||0.012|TWO_SIDED|95.0|0.824|0.976|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||0.976|0.824|0.012
73873000|NCT05169424|147288910|OTHER|||||||0.974|||||||t-test, 2 sided|||||||0.974
73952863|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|10.6|||<|0.001|TWO_SIDED|95.0|4.4|16.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||16.7|4.4|<0.001
73952864|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|4.7||||0.22|TWO_SIDED|95.0|-3.1|12.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||12.6|-3.1|0.22
73980217|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.57|||||TWO_SIDED|95.0|11.11|27.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||27.79|11.11|
74033029|NCT00074412|147619062|SUPERIORITY_OR_OTHER_LEGACY||18 mon. Rate of Cum. HIV Infection (%)|3.1|||||TWO_SIDED|95.0|1.9|4.4|||Kaplan-Meier Method|||The cumulative rate of HIV infection at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||4.4|1.9|
74033030|NCT00074412|147619062|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.081||||0.28||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV infection at 18 months were calculated using the Kaplan-Meier method and were compared between arms using a Z statistic.||||0.280
74033031|NCT00074412|147619063|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 18mon (%)|4.7|||||TWO_SIDED|95.0|2.0|7.4|||Kaplan-Meier Method|||||7.4|2.0|
74033032|NCT00074412|147619063|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 18mon (%)|4.1|||||TWO_SIDED|95.0|2.7|5.6|||Kaplan-Meier Method|||||5.6|2.7|
74089446|NCT02697773|147731643|SUPERIORITY|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.1||0.0942|TWO_SIDED|95.0|0.65|1.03|||Negative binomial model|||||1.03|0.65|0.0942
73873001|NCT05169424|147288910|OTHER||Exponential estimate|1.135||||0.595|TWO_SIDED|95.0|0.711|1.812|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||1.812|0.711|0.595
73873002|NCT05169424|147288911|OTHER|||||||0.622|||||||t-test, 2 sided|||||||0.622
73873003|NCT05169424|147288911|OTHER||Exponential estimate|1.008||||0.855|TWO_SIDED|95.0|0.928|1.094|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||1.094|0.928|0.855
73873004|NCT05169424|147288912|OTHER|||||||0.328|||||||t-test, 2 sided|||||||0.328
73873005|NCT00595478|147288914|SUPERIORITY||Odds Ratio (OR)|0.8||||0.66|TWO_SIDED|95.0|0.29|2.18|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0 ETG-positive samples for MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||2.18|0.29|0.66
73873006|NCT00595478|147288914|SUPERIORITY||mean ratio|0.93||||0.61|TWO_SIDED|95.0|0.71|1.22|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for number of ETG-positive samples, if \>0 ETG-positive samples: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||1.22|0.71|0.61
73952865|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|4.3||||0.25|TWO_SIDED|95.0|-3.6|12.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||12.1|-3.6|0.25
73873007|NCT00595478|147288915|SUPERIORITY||Odds Ratio (OR)|0.82||||0.74|TWO_SIDED|95.0|0.26|2.62|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0% days using alcohol during the 36 week follow-up period: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||2.62|0.26|0.74
73873008|NCT00595478|147288915|SUPERIORITY||mean ratio|0.74||||0.007|TWO_SIDED|95.0|0.59|0.92|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for percentage of days with alcohol use during the 36 week follow-up period, if alcohol was used: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||.92|.59|0.007
74033033|NCT00074412|147619063|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|-0.247||||0.805||95.0||||P-value was not adjusted for interim analysis or multiple testing|Z-test|||The cumulative rates of mortality at 6 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z-statistic.||||0.805
74033034|NCT00074412|147619063|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 6mon (%)|1.2|||||TWO_SIDED|95.0|0.4|2.0|||Kaplan-Meier Method|||||2.0|0.4|
74033035|NCT00074412|147619063|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 6mon (%)|1.1|||||TWO_SIDED|95.0|0.3|1.8|||Kaplan-Meier Method|||||1.8|0.3|
74033036|NCT00074412|147619063|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|-0.36||||0.719||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative mortality rates at 18 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z statistic.||||0.719
74033037|NCT00074412|147619063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.611||95.0|||||Log Rank|||We compared the cumulative mortality rates, as calculated using Kaplan-Meier, between the two study groups over all 18 months of the study follow-up using a log-rank test.||||0.611
74033038|NCT02891798|147619064|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Total Score Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.003
74033039|NCT02891798|147619065|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Continuous Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.001
74033040|NCT02891798|147619066|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Intermittent Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.038
74033041|NCT02891798|147619067|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||Comparison of QoR-15 Total Score at post-operative day 1 between the 4-drug nerve block group and the bupivacaine only group||||0.009
74033042|NCT02891798|147619068|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the QoR-15 Total Score.||||||0.861|||||||t-test, 2 sided|||Comparison of QoR-15 Total Score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group||||0.861
74033043|NCT02891798|147619069|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the Standing Balance test.||||||0.512|||||||t-test, 2 sided|||Comparison of Standing Balance Test score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group||||0.512
74033044|NCT02891798|147619070|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower rate for the Self-Selected Gait Speed test.||||||0.339|||||||t-test, 2 sided|||Comparison of Self-Selected Gait Speed rate at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.||||0.339
73873009|NCT02363959|147288976|OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1
73873010|NCT02363959|147288977|OTHER|||||||0.39|||||||Fisher Exact|||||||0.39
73873011|NCT02363959|147288978|OTHER|||||||1|||||||Fisher Exact|||||||1
73873012|NCT02363959|147288979|OTHER|||||||1|||||||Fisher Exact|||||||1
73873013|NCT02363959|147288980|OTHER|||||||1|||||||Fisher Exact|||||||1
73873014|NCT02363959|147288981|OTHER|||||||1|||||||Fisher Exact|||||||1
73980218|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.22|||||TWO_SIDED|95.0|2.86|6.23|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.23|2.86|
73980219|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.54|||||TWO_SIDED|95.0|1.78|3.62|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.62|1.78|
73980220|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.21|||||TWO_SIDED|95.0|2.86|6.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.19|2.86|
73980221|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.23|||||TWO_SIDED|95.0|2.79|6.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.42|2.79|
73873015|NCT02267538|147289002|OTHER||Odds Ratio (OR)|0.62||||0.341|TWO_SIDED|95.0|0.23|1.65|||Regression, Logistic|||||1.65|0.23|0.341
73873016|NCT02267538|147289003|OTHER||Median Difference (Final Values)|0.0||||0.83|TWO_SIDED|||||MMSE|Wilcoxon (Mann-Whitney)|||||||0.830
73873017|NCT02267538|147289003|OTHER||Median Difference (Final Values)|0.0||||0.405|TWO_SIDED|||||m-TICS|Wilcoxon (Mann-Whitney)|||||||0.405
73873018|NCT02267538|147289004|OTHER||Odds Ratio (OR)|0.74||||0.214|TWO_SIDED|95.0|0.47|1.19|||Regression, Logistic|||Incidence of total non-delirium complications within 30 days after surgery||1.19|0.47|0.214
73873019|NCT02267538|147289004|OTHER|stroke|Odds Ratio (OR)|1.01||||0.993|TWO_SIDED|95.0|0.2|5.08|||Regression, Logistic|||Incidence of stroke within 30 days after surgery||5.08|0.20|0.993
73873020|NCT02267538|147289004|OTHER|New onset arrythmia|Odds Ratio (OR)|0.76||||0.274|TWO_SIDED|95.0|0.46|1.25|||Regression, Logistic|||||1.25|0.46|0.274
73873021|NCT02267538|147289004|OTHER|Pulmonary complications|Odds Ratio (OR)|0.51||||0.05|TWO_SIDED|95.0|0.26|1.0|||Regression, Logistic|||||1.00|0.26|0.050
73873022|NCT02267538|147289004|OTHER||Odds Ratio (OR)|0.5||||0.423|TWO_SIDED|95.0|0.09|2.75||Upper gastrointestinal bleeding|Regression, Logistic|||||2.75|0.09|0.423
73873023|NCT02267538|147289004|OTHER||Odds Ratio (OR)|1.01||||0.993|TWO_SIDED|95.0|0.2|5.08||Surgical bleeding|Regression, Logistic|||||5.08|0.20|0.993
73873024|NCT02267538|147289004|OTHER||Odds Ratio (OR)|1.63||||0.326|TWO_SIDED|95.0|0.61|4.34||Wound dehiscence or infection|Regression, Logistic|||||4.34|0.61|0.326
73873025|NCT02267538|147289004|OTHER||Odds Ratio (OR)|0.79||||0.378|TWO_SIDED|95.0|0.47|1.33||Acute kidney injur|Regression, Logistic|||||1.33|0.47|0.378
73873026|NCT02267538|147289004|OTHER||Odds Ratio (OR)|0.48||||0.156|TWO_SIDED|95.0|0.18|1.32||IABP assistance|Regression, Logistic|||||1.32|0.18|0.156
73873027|NCT02267538|147289005|OTHER||Median Difference (Final Values)|0.0||||0.596|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 4, i.e., Pain score in Day 1 after surgery, at rest between DEX Group and CTRL group||0|-1|0.596
73873028|NCT02267538|147289005|OTHER||Median Difference (Final Values)|0.0||||0.743|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 4, i.e., Pain score in Day 2 after surgery, at rest between DEX Group and CTRL group||0|-1|0.743
73873029|NCT02267538|147289005|OTHER||Median Difference (Final Values)|0.0||||0.282|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 4, i.e., Pain score in Day 3 after surgery, at rest between DEX Group and CTRL group||0|-1|0.282
73873030|NCT02267538|147289005|OTHER||Median Difference (Final Values)|0.0||||0.368|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 4, i.e., Pain score in Day 4 after surgery, at rest between DEX Group and CTRL group||0|0|0.368
73873031|NCT02267538|147289005|OTHER||Median Difference (Final Values)|0.0||||0.397|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 4, i.e., Pain score in Day 5 after surgery, at rest between DEX Group and CTRL group||0|0|0.397
73873032|NCT02267538|147289005|OTHER||Median Difference (Final Values)|0.0||||0.486|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the sixth row in Outcome 4, i.e., Pain score in Day 1 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.486
73873033|NCT02267538|147289005|OTHER||Median Difference (Final Values)|0.0||||0.414|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the seventh row in Outcome 4, i.e., Pain score in Day 2 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.414
73873034|NCT02267538|147289005|OTHER||Median Difference (Final Values)|0.0||||0.187|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the eighth row in Outcome 4, i.e., Pain score in Day 3 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.187
73873035|NCT02267538|147289005|OTHER||Median Difference (Final Values)|0.0||||0.127|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the ninth row in Outcome 4, i.e., Pain score in Day 4 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.127
73873036|NCT02267538|147289005|OTHER||Median Difference (Final Values)|0.0||||0.378|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the tenth row in Outcome 4, i.e., Pain score in Day 5 after surgery, with coughing between DEX Group and CTRL group||0|0|0.378
73873037|NCT02267538|147289006|OTHER||Median Difference (Final Values)|0.0||||0.777|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 5, i.e., subjective sleep quality in Day 1 after surgery, between DEX Group and CTRL group||0|0|0.777
73873038|NCT02267538|147289006|OTHER||Median Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 5, i.e., subjective sleep quality in Day 2 after surgery, between DEX Group and CTRL group||1|-1|0.919
73873039|NCT02267538|147289006|OTHER||Median Difference (Final Values)|0.0||||0.835|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 5, i.e., subjective sleep quality in Day 3 after surgery, between DEX Group and CTRL group||0|0|0.835
73873040|NCT02267538|147289006|OTHER||Median Difference (Final Values)|0.0||||0.321|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 5, i.e., subjective sleep quality in Day 4 after surgery, between DEX Group and CTRL group||0|0|0.321
73873041|NCT02267538|147289006|OTHER||Median Difference (Final Values)|0.0||||0.174|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 5, i.e., subjective sleep quality in Day 5 after surgery, between DEX Group and CTRL group||0|0|0.174
73873042|NCT02267538|147289007|OTHER||Hazard Ratio (HR)|1.03||||0.788|TWO_SIDED|95.0|0.82|1.31|||Log Rank|||||1.31|0.82|0.788
73980222|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.63|||||TWO_SIDED|95.0|1.3|2.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.05|1.30|
73873043|NCT02267538|147289008|OTHER||Hazard Ratio (HR)|0.97||||0.826|TWO_SIDED|95.0|0.77|1.23|||Log Rank|||||1.23|0.77|0.826
73873044|NCT01223183|147289034|EQUIVALENCE|alpha=0.05|||||<|0.001|||||||t-test, 2 sided|||Comparing DTPA absorption after hypertonic saline inhalation to DTPA absorption after isotonic saline inhalation||||<0.001
73980223|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.67|||||TWO_SIDED|95.0|1.3|2.14|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.14|1.30|
73980224|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.6|||||TWO_SIDED|95.0|2.39|5.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.42|2.39|
73980225|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.41|||||TWO_SIDED|95.0|2.42|4.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.82|2.42|
74033045|NCT02891798|147619071|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower time for the Repeated Chair Stand test.||||||0.711|||||||t-test, 2 sided|||Comparison of Repeated Chair Stand time at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.||||0.711
73873045|NCT01223183|147289036|EQUIVALENCE|alpha=0.05||||||0.003|||||||t-test, 2 sided|||Comparing mucociliary clearance after isotonic saline inhalation to mucociliary clearance after hypertonic saline inhalation||||0.003
73873046|NCT03152591|147289044|OTHER||Ratio LIK066/Placebo|0.88||||0.353|TWO_SIDED|90.0|0.7|1.11|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline in average fasting free testosterone was analyzed using an analysis of covariance model which included treatment as a categorical factor, baseline body weight and log transformed baseline average fasting free testosterone as a covariate.|1.11|0.70|0.353
73873047|NCT03152591|147289045|OTHER||Ratio LIK066/Placebo|1.25||||0.218|TWO_SIDED|90.0|0.92|1.68|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.68|0.92|0.218
73952866|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|2.7||||0.35|TWO_SIDED|95.0|-3.5|8.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||8.9|-3.5|0.35
73952867|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|4.6||||0.2|TWO_SIDED|95.0|-2.9|12.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||12.1|-2.9|0.20
73952868|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|3.1||||0.36|TWO_SIDED|95.0|-4.5|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||10.6|-4.5|0.36
73952869|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|6.3||||0.043|TWO_SIDED|95.0|-0.2|12.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||12.8|-0.2|0.043
73952870|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|9.4||||0.015|TWO_SIDED|95.0|1.6|17.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||17.2|1.6|0.015
73952871|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|6.5||||0.085|TWO_SIDED|95.0|-1.5|14.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||14.4|-1.5|0.085
73980226|NCT00824850|147505636|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.6|2.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.26|1.60|
73980227|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.36|||||TWO_SIDED|95.0|4.5|15.56|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.56|4.50|
73980228|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.37|||||TWO_SIDED|95.0|1.78|3.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.16|1.78|
73980229|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.02|||||TWO_SIDED|95.0|1.63|2.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.49|1.63|
73980230|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.61|||||TWO_SIDED|95.0|4.31|10.15|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.15|4.31|
73980231|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.92|||||TWO_SIDED|95.0|3.34|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.26|3.34|
73980232|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.73|||||TWO_SIDED|95.0|2.08|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.57|2.08|
73980233|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.82|||||TWO_SIDED|95.0|2.08|3.83|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.83|2.08|
73980234|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.79|||||TWO_SIDED|95.0|2.8|5.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.13|2.80|
73980235|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.32|||||TWO_SIDED|95.0|1.11|1.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.57|1.11|
73980236|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.61|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.61|1.05|
73980237|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.04|||||TWO_SIDED|95.0|1.51|2.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.75|1.51|
73980238|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.87|||||TWO_SIDED|95.0|2.19|3.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.77|2.19|
73980239|NCT00824850|147505637|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.95|||||TWO_SIDED|95.0|1.59|2.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.39|1.59|
73873048|NCT03152591|147289046|OTHER||Ratio LIK066/Placebo|1.27||||0.249|TWO_SIDED|90.0|0.9|1.78|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.78|0.90|0.249
73980240|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|201.8|||||TWO_SIDED|95.0|55.11|739.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||739.05|55.11|
73873049|NCT03152591|147289047|OTHER||Ratio LIK066/Placebo|1.15||||0.173|TWO_SIDED|90.0|0.97|1.36|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.36|0.97|0.173
73952872|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|9.9||||0.002|TWO_SIDED|95.0|3.2|16.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||16.6|3.2|0.002
73952873|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|10.5||||0.01|TWO_SIDED|95.0|2.3|18.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||18.7|2.3|0.010
73952874|NCT02886728|147439419|SUPERIORITY||Difference in Response Rates|9.6||||0.014|TWO_SIDED|95.0|1.4|17.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||17.8|1.4|0.014
73952875|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
73952876|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.7|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.7|<0.001
73980241|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.7|||||TWO_SIDED|95.0|5.2|26.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||26.10|5.20|
73980242|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|156.4|||||TWO_SIDED|95.0|48.72|501.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||501.86|48.72|
73980243|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|37.4|||||TWO_SIDED|95.0|13.71|102.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||102.31|13.71|
73980244|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|93.9|||||TWO_SIDED|95.0|30.99|284.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||284.31|30.99|
73980245|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|48.7|||||TWO_SIDED|95.0|23.27|101.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||101.97|23.27|
73980246|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|32.1|||||TWO_SIDED|95.0|11.99|85.81|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||85.81|11.99|
74033046|NCT00418834|147619080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-16.0|-11.7|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-11.7|-16.0|<0.001
74033047|NCT00418834|147619081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-7.4|-1.8|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-1.8|-7.4|<0.001
74033048|NCT00418834|147619082|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.32|||<|0.001||95.0|4.52|8.84|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg|||8.84|4.52|<0.001
74033049|NCT00418834|147619083|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87|||<|0.001||95.0|1.4|2.5|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg|||2.50|1.40|<0.001
74033050|NCT00418834|147619084|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.48|||<|0.001||95.0|3.98|7.55|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg|||7.55|3.98|<0.001
74033051|NCT00418834|147619085|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||<|0.001||95.0|1.32|2.31|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg|||2.31|1.32|<0.001
73952877|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
73980247|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|78.1|||||TWO_SIDED|95.0|50.42|120.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||120.94|50.42|
73980248|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|10.3|||||TWO_SIDED|95.0|6.8|15.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.72|6.80|
74033052|NCT00418834|147619086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|0.3|3.5|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||3.5|0.3|<0.001
73873050|NCT03152591|147289048|OTHER||Ratio LIK066/Placebo|0.82||||0.089|TWO_SIDED|90.0|0.68|0.99|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|0.99|0.68|0.089
73952878|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
73952879|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.9|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.9|<0.001
73952880|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.0|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.0|<0.001
73952881|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.0|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.0|<0.001
73952882|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.8|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.8|<0.001
73952883|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.9|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.9|<0.001
73952884|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
73952885|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
73952886|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
73952887|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.6|<0.001
73952888|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.4|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-0.4|0.033
73980249|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.7|||||TWO_SIDED|95.0|32.75|116.34|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||116.34|32.75|
73980250|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|536.5|||||TWO_SIDED|95.0|212.04|1357.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1357.19|212.04|
73980251|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|116.9|||||TWO_SIDED|95.0|33.28|410.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||410.33|33.28|
73980252|NCT00824850|147505638|SUPERIORITY_OR_OTHER||geometric mean fold rise|24.6|||||TWO_SIDED|95.0|11.3|53.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||53.42|11.30|
73980253|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|168.8|||||TWO_SIDED|95.0|20.22|1409.76|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1409.76|20.22|
73980254|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|40.3|||||TWO_SIDED|95.0|10.97|148.44|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||148.44|10.97|
73980255|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.9|||||TWO_SIDED|95.0|18.83|203.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||203.72|18.83|
73980256|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|26.7|||||TWO_SIDED|95.0|9.67|73.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||73.84|9.67|
73980257|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|226.9|||||TWO_SIDED|95.0|79.81|645.29|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||645.29|79.81|
73980258|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|116.8|||||TWO_SIDED|95.0|54.54|250.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||250.13|54.54|
73980259|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|481.0|||||TWO_SIDED|95.0|207.01|1117.69|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1117.69|207.01|
73980260|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|66.5|||||TWO_SIDED|95.0|41.8|105.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||105.75|41.80|
73873051|NCT03152591|147289049|OTHER||Ration LIK066/Placebo|0.69||||0.109|TWO_SIDED|90.0|0.48|1.01|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.01|0.48|0.109
73873052|NCT03152591|147289050|OTHER||Ration LIK066/Placebo|0.76||||0.008|TWO_SIDED|90.0|0.65|0.89|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|0.89|0.65|0.008
73873053|NCT03152591|147289051|OTHER||Ratio LIK066/Placebo|0.91||||0.34|TWO_SIDED|90.0|0.77|1.07|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.07|0.77|0.340
73980261|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.6|||||TWO_SIDED|95.0|5.36|13.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||13.94|5.36|
73980262|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|78.2|||||TWO_SIDED|95.0|41.38|147.8|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||147.80|41.38|
73980263|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|438.1|||||TWO_SIDED|95.0|169.52|1132.43|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1132.43|169.52|
73980264|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|80.0|||||TWO_SIDED|95.0|23.28|274.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||274.82|23.28|
73980265|NCT00824850|147505639|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.5|||||TWO_SIDED|95.0|28.73|131.76|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||131.76|28.73|
73980266|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|281.7|||||TWO_SIDED|95.0|76.65|1035.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1035.49|76.65|
73980267|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.6|||||TWO_SIDED|95.0|3.47|16.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||16.75|3.47|
74033053|NCT00418834|147619087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|1.5|4.8|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||4.8|1.5|<0.001
73952889|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.2|-0.6|<0.001
73952890|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
73952891|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.2|-0.6|<0.001
73980268|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|151.4|||||TWO_SIDED|95.0|42.01|545.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||545.84|42.01|
74033054|NCT00418834|147619088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-14.2|-10.3|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-10.3|-14.2|<0.001
74033055|NCT00418834|147619089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|-6.8|-1.7|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-1.7|-6.8|<0.001
74033056|NCT00418834|147619090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.001||95.0|-9.4|-6.5|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-6.5|-9.4|<0.001
73952892|NCT02886728|147439420|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
73952893|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|18.8|||<|0.001|TWO_SIDED|95.0|13.1|24.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||24.4|13.1|<0.001
73952894|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|11.7|||<|0.001|TWO_SIDED|95.0|4.7|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||18.6|4.7|<0.001
73952895|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|19.9|||<|0.001|TWO_SIDED|95.0|12.5|27.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||27.3|12.5|<0.001
73952896|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|27.2|||<|0.001|TWO_SIDED|95.0|20.5|33.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||33.9|20.5|<0.001
73952897|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|21.6|||<|0.001|TWO_SIDED|95.0|13.2|30.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||30.1|13.2|<0.001
73952898|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|19.5|||<|0.001|TWO_SIDED|95.0|11.1|27.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||27.9|11.1|<0.001
73952899|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|22.6|||<|0.001|TWO_SIDED|95.0|15.8|29.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||29.4|15.8|<0.001
73952900|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|16.6|||<|0.001|TWO_SIDED|95.0|8.1|25.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||25.2|8.1|<0.001
73952901|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|5.3|22.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||22.4|5.3|<0.001
74033057|NCT00418834|147619091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-3.8|-0.2|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-0.2|-3.8|<0.001
73952902|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|21.4|||<|0.001|TWO_SIDED|95.0|14.6|28.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||28.2|14.6|<0.001
73952903|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|12.3||||0.003|TWO_SIDED|95.0|3.7|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||20.9|3.7|0.003
73952904|NCT02886728|147439421|SUPERIORITY||Difference in Response Rates|18.1|||<|0.001|TWO_SIDED|95.0|9.7|26.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||26.5|9.7|<0.001
73952905|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|6.3|||<|0.001|TWO_SIDED|95.0|3.4|9.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||9.1|3.4|<0.001
73952906|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|3.4||||0.01|TWO_SIDED|95.0|0.1|6.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||6.7|0.1|0.010
73952907|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|9.0|||<|0.001|TWO_SIDED|95.0|4.5|13.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||13.6|4.5|<0.001
73952908|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|11.8|||<|0.001|TWO_SIDED|95.0|7.4|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||16.1|7.4|<0.001
73952909|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|10.2|||<|0.001|TWO_SIDED|95.0|4.5|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||15.8|4.5|<0.001
73952910|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|8.6|20.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||20.8|8.6|<0.001
73952911|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|22.6|||<|0.001|TWO_SIDED|95.0|16.4|28.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||28.8|16.4|<0.001
74089447|NCT02697773|147731643|SUPERIORITY||LS Mean Ratio|0.88|STANDARD_ERROR_OF_MEAN|0.12||0.3371|TWO_SIDED|95.0|0.67|1.15|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.15|0.67|0.3371
73952912|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|14.8|||<|0.001|TWO_SIDED|95.0|7.1|22.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||22.5|7.1|<0.001
73952913|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|12.5|||<|0.001|TWO_SIDED|95.0|4.9|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||20.0|4.9|<0.001
73952914|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|18.3|||<|0.001|TWO_SIDED|95.0|11.4|25.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||25.1|11.4|<0.001
73952915|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|7.7||||0.056|TWO_SIDED|95.0|-0.8|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||16.1|-0.8|0.056
73952916|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|9.0||||0.023|TWO_SIDED|95.0|0.5|17.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||17.4|0.5|0.023
73980269|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|23.7|||||TWO_SIDED|95.0|8.67|64.54|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||64.54|8.67|
73980270|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|102.1|||||TWO_SIDED|95.0|32.0|325.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||325.40|32.00|
73873054|NCT03152591|147289052|OTHER||Ratio LIK066/Placebo|0.79||||0.204|TWO_SIDED|90.0|0.58|1.08|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.08|0.58|0.204
73873055|NCT03868254|147289083|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
73873056|NCT03868254|147289083|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
73873057|NCT03868254|147289084|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
73873058|NCT03868254|147289084|OTHER|||||||0.0001|||||||Paired t-test|||||||0.0001
73873059|NCT03868254|147289085|OTHER|||||||0.003|||||||Paired t-test|||||||0.0030
73873060|NCT03868254|147289085|OTHER|||||||0.0018|||||||Paired t-test|||||||0.0018
73873061|NCT03868254|147289086|OTHER|||||||0.0053|||||||Paired t-test|||||||0.0053
73952917|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|21.9|||<|0.001|TWO_SIDED|95.0|15.1|28.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||28.7|15.1|<0.001
73952918|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|11.5||||0.004|TWO_SIDED|95.0|3.1|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||20.0|3.1|0.004
73952919|NCT02886728|147439422|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|6.3|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||23.1|6.3|<0.001
73952920|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-7.3|-4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.1|-7.3|<0.001
73952921|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-6.4|-2.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.4|-6.4|<0.001
73952922|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-7.7|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-7.7|<0.001
73952923|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-8.9|-5.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.6|-8.9|<0.001
73873062|NCT03868254|147289086|OTHER|||||||0.0472|||||||Paired t-test|||||||0.0472
73952924|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-7.3|-3.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.3|-7.3|<0.001
73952925|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-7.8|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-7.8|<0.001
73952926|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|0.72|<|0.001|TWO_SIDED|95.0|-7.3|-4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.4|-7.3|<0.001
73952927|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.1|-2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.7|-6.1|<0.001
73952928|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.8|-3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.4|-6.8|<0.001
73952929|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-5.3|-2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-5.3|<0.001
73952930|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-4.3|-1.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.3|-4.3|<0.001
73952931|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-4.4|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-4.4|<0.001
73952932|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.4|-1.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.1|-3.4|<0.001
73952933|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.71||0.36|TWO_SIDED|95.0|-2.0|0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.8|-2.0|0.36
73952934|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.72||0.009|TWO_SIDED|95.0|-3.3|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-3.3|0.009
73980271|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|31.1|||||TWO_SIDED|95.0|12.71|76.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||76.13|12.71|
73873063|NCT02871635|147289096|OTHER||Risk Ratio (RR)|0.945|||||TWO_SIDED|90.0|0.87|1.028|||||BI 695501 as numerator Humira EU as denominator|Was analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.028|0.870|
73873064|NCT02871635|147289096|OTHER||Risk Ratio (RR)|0.945|||||TWO_SIDED|95.0|0.856|1.044|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.044|0.856|
73873065|NCT02871635|147289097|OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|90.0|0.871|1.148|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.148|0.871|
73873066|NCT02871635|147289097|OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.848|1.178|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.178|0.848|
73873067|NCT02871635|147289098|OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|90.0|0.751|1.078|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.078|0.751|
73873068|NCT02871635|147289098|OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.725|1.116|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.116|0.725|
73980272|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|18.7|||||TWO_SIDED|95.0|6.82|51.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||51.39|6.82|
73873069|NCT01426958|147289164|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|119.3|STANDARD_DEVIATION|11.5||0.1009|TWO_SIDED|90.0|112.239|126.811||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||126.811|112.239|0.1009
73873070|NCT01426958|147289164|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|110.23|STANDARD_DEVIATION|10.9||0.0009|TWO_SIDED|90.0|103.837|117.006||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||117.006|103.837|0.0009
73873071|NCT01426958|147289164|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|91.9|STANDARD_DEVIATION|11.6||0.0004|TWO_SIDED|90.0|86.519|97.614||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||97.614|86.519|0.0004
73873072|NCT01426958|147289165|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|104.06|STANDARD_DEVIATION|14.2||0.0002|TWO_SIDED|90.0|96.681|112.002||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||112.002|96.681|0.0002
73873073|NCT01426958|147289165|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|105.09|STANDARD_DEVIATION|16.1||0.0012|TWO_SIDED|90.0|96.425|114.53||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||114.530|96.425|0.0012
73873074|NCT01426958|147289165|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|99.75|STANDARD_DEVIATION|12.8||0|TWO_SIDED|90.0|93.328|106.61||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||106.610|93.328|0.0000
73873075|NCT01426958|147289166|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|118.56|STANDARD_DEVIATION|11.5||0.0702|TWO_SIDED|90.0|111.712|125.822||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||125.822|111.712|0.0702
73873076|NCT01426958|147289166|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|110.76|STANDARD_DEVIATION|10.0||0.0005|TWO_SIDED|90.0|104.936|116.913||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||116.913|104.936|0.0005
73952935|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-4.5|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-4.5|<0.001
73952936|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.69||0.042|TWO_SIDED|95.0|-2.7|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.1|-2.7|0.042
73873077|NCT01426958|147289166|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|92.46|STANDARD_DEVIATION|11.9||0.0003|TWO_SIDED|90.0|86.928|98.341||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||98.341|86.928|0.0003
73980273|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|64.4|||||TWO_SIDED|95.0|37.33|111.18|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||111.18|37.33|
74089448|NCT02697773|147731643|SUPERIORITY||LS Mean Ratio|0.76|STANDARD_ERROR_OF_MEAN|0.11||0.0508|TWO_SIDED|95.0|0.58|1.0|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.00|0.58|0.0508
74089449|NCT02697773|147731643|SUPERIORITY||LS Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.14||0.728|TWO_SIDED|95.0|0.71|1.27|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.27|0.71|0.7280
73873078|NCT02968368|147289167|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0149|TWO_SIDED|95.0|0.102|0.93|||ANCOVA|||||0.930|0.102|0.0149
73873079|NCT02968368|147289172|SUPERIORITY||Mean Difference (Final Values)|39.03|STANDARD_ERROR_OF_MEAN|11.097||0.0006|TWO_SIDED|95.0|17.07|60.992|||ANCOVA|||||60.992|17.070|0.0006
73873080|NCT02968368|147289175|SUPERIORITY||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|1.282||0.0007|TWO_SIDED|95.0|1.928|7.001|||ANCOVA|||||7.001|1.928|0.0007
73873081|NCT02968368|147289176|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|0.708||0.0098|TWO_SIDED|95.0|0.457|3.261|||ANCOVA|||||3.261|0.457|0.0098
73873082|NCT00991939|147289179|SUPERIORITY_OR_OTHER||Difference of proportions|0.0|STANDARD_ERROR_OF_MEAN|0.58||1|TWO_SIDED|95.0|-0.975|0.708|||Fisher Exact||The estimated value is the proportion of success in the high dose pulse dexamethasone group minus the proportion of success in the standard prednisone group.|Four subjects were not included in this analysis because not enough data was available to assess the primary outcome at the time the study was terminated.||0.708|-0.975|1.00
73952937|NCT02886728|147439425|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-3.7|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.7|<0.001
74089450|NCT02697773|147731643|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.3244|TWO_SIDED|95.0|0.65|1.15|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.15|0.65|0.3244
74089451|NCT02697773|147731643|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.16||0.5681|TWO_SIDED|95.0|0.65|1.27|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.27|0.65|0.5681
74089452|NCT02697773|147731643|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.13||0.1387|TWO_SIDED|95.0|0.55|1.09|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.09|0.55|0.1387
73873083|NCT02073682|147289199|NON_INFERIORITY|Edoxaban Group was considered non-inferior to the Dalteparin Group if the upper limit of the 2-sided 95% confidence interval (CI) for the Hazard Ratio (\[LMW\] Edoxaban Group to Dalteparin Group) was less than 1.5.|Cox Proportional Hazard|0.97||||0.0056|TWO_SIDED|95.0|0.696|1.359|||Cox proportional hazard|||||1.359|0.696|0.0056
73952938|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-8.5|-5.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.2|-8.5|<0.001
73952939|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-7.3|-3.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.3|-7.3|<0.001
74089453|NCT02697773|147731643|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.18||0.7275|TWO_SIDED|95.0|0.76|1.48|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.48|0.76|0.7275
73952940|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|1.03|<|0.001|TWO_SIDED|95.0|-8.8|-4.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.7|-8.8|<0.001
73980274|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|6.64|18.52|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||18.52|6.64|
73980275|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|41.2|||||TWO_SIDED|95.0|23.09|73.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||73.48|23.09|
73980276|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|479.6|||||TWO_SIDED|95.0|171.63|1339.96|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1339.96|171.63|
73980277|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|76.4|||||TWO_SIDED|95.0|21.63|270.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||270.02|21.63|
73980278|NCT00824850|147505640|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.7|||||TWO_SIDED|95.0|7.61|41.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||41.08|7.61|
73980279|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|170.2|||||TWO_SIDED|95.0|22.24|1301.79|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1301.79|22.24|
73980280|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.8|||||TWO_SIDED|95.0|5.27|59.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||59.91|5.27|
73980281|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|67.8|||||TWO_SIDED|95.0|18.45|249.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||249.02|18.45|
74033058|NCT00418834|147619092|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.2|||<|0.001||95.0|-9.0|-3.4|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"|||-3.4|-9.0|<0.001
74089454|NCT02697773|147731643|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|0.67|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.31|0.67|0.7090
73980282|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|22.2|||||TWO_SIDED|95.0|7.94|61.88|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||61.88|7.94|
74033059|NCT00418834|147619093|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.1|||<|0.001||95.0|-5.2|1.0|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates~of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"|||1.0|-5.2|<0.001
74089455|NCT02697773|147731645|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.25||0.9164|TWO_SIDED|95.0|0.58|1.62|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.62|0.58|0.9164
74089456|NCT02697773|147731645|SUPERIORITY|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.2||0.3542|TWO_SIDED|95.0|0.47|1.31|||Negative binomial model|||||1.31|0.47|0.3542
74089457|NCT02697773|147731645|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.28||0.8065|TWO_SIDED|95.0|0.51|1.68|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.68|0.51|0.8065
73873084|NCT02073682|147289199|SUPERIORITY|The hazard ratio (HR), two-sided confidence interval (CI) and p-value are based on the Cox proportional hazard model including treatment and the two stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||||||0.8712|||||||Cox proportional hazard|||||||0.8712
73873085|NCT02073682|147289200|SUPERIORITY||Hazard Ratio (HR)|2.0||||0.0254|TWO_SIDED|95.0|1.089|3.657|||Regression, Cox|||The HR, 2-sided CI and p-value are based on the Cox regression model with counting process approach for on-treatment including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||3.657|1.089|0.0254
73873086|NCT02073682|147289201|SUPERIORITY||Cox Proportional Hazard|0.71||||0.0931|TWO_SIDED|95.0|0.476|1.059|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.059|0.476|0.0931
73873087|NCT02073682|147289202|SUPERIORITY||Cox Proportional Hazard|0.56||||0.0394|TWO_SIDED|95.0|0.318|0.972|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||0.972|0.318|0.0394
73952941|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-9.9|-6.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.6|-9.9|<0.001
73873088|NCT02073682|147289203|SUPERIORITY||Cox Proportional Hazard|0.9||||0.7324|TWO_SIDED|95.0|0.502|1.624|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.624|0.502|0.7324
73873089|NCT02073682|147289204|SUPERIORITY||Cox Proportional Hazard|1.56||||0.4873|TWO_SIDED|95.0|0.444|5.505|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||5.505|0.444|0.4873
73873090|NCT02073682|147289205|SUPERIORITY||Cox Proportional Hazard|1.08||||0.4199|TWO_SIDED|95.0|0.898|1.293|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.293|0.898|0.4199
73873091|NCT00855816|147289208|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|||||A priori threshold for significance: p\<.05.|Mixed Models Analysis|Mixed model based on intent to treat sample.||Null hypothesis: there will be no differences in PTSD hyperarousal symptom changes in individuals who did receive the experimental intervention vs. those who did not .||||.27
73952942|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-8.2|-4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.1|-8.2|<0.001
73952943|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-8.5|-4.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-8.5|<0.001
73873092|NCT03393494|147289209|EQUIVALENCE|provides 85% power of success|Equivalence ratio|107.0|||||TWO_SIDED|90.0|97.8|112.2|||Fieller's method|||||112.2|97.8|
73873093|NCT03393494|147289210|EQUIVALENCE|provides 85% power of success|Equivalence ratio|104.0||||0.05|TWO_SIDED|90.0|94.1|108.5|||Fieller's method|||||108.5|94.1|0.05
73873094|NCT01965704|147289211|OTHER|||||||0.2|||||||Fisher Exact|||||||0.2
73952944|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|-8.0|-5.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.1|-8.0|<0.001
73952945|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.5|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.5|<0.001
73952946|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.4|-3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.8|-7.4|<0.001
74033060|NCT00418834|147619094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.1|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-11.0|-7.3|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.3|-11.0|<0.001
74033061|NCT00418834|147619095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-5.5|-0.9|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-0.9|-5.5|<0.001
73952947|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-5.9|-3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.4|-5.9|<0.001
73952948|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.6|-1.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-4.6|<0.001
73952949|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-4.9|-1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.9|-4.9|<0.001
73952950|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.8|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-3.8|<0.001
73952951|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.74||0.23|TWO_SIDED|95.0|-2.4|0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.6|-2.4|0.23
73952952|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.005|TWO_SIDED|95.0|-3.6|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-3.6|0.005
73952953|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.6|-5.0|<0.001
73952954|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.73||0.021|TWO_SIDED|95.0|-3.1|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-3.1|0.021
73952955|NCT02886728|147439426|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-4.3|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-4.3|<0.001
73952956|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|7.6||||0.006|TWO_SIDED|95.0|2.2|12.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||12.9|2.2|0.006
73952957|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|4.9||||0.16|TWO_SIDED|95.0|-1.8|11.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||11.6|-1.8|0.16
73952958|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|7.6||||0.029|TWO_SIDED|95.0|1.1|14.1||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||14.1|1.1|0.029
73952959|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|8.1||||0.015|TWO_SIDED|95.0|1.6|14.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||14.6|1.6|0.015
73952960|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|4.2||||0.33|TWO_SIDED|95.0|-3.9|12.2||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||12.2|-3.9|0.33
74089458|NCT02697773|147731645|SUPERIORITY||LS Mean Ratio|0.66|STANDARD_ERROR_OF_MEAN|0.2||0.1752|TWO_SIDED|95.0|0.36|1.2|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.20|0.36|0.1752
73873095|NCT01965704|147289212|OTHER||Mean Difference (Final Values)|-1.9||||0.56|TWO_SIDED|95.0|-8.0|4.3|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|Difference in overall length of stay.||4.3|-8.0|0.56
73952961|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|10.2||||0.013|TWO_SIDED|95.0|2.5|17.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||17.9|2.5|0.013
73952962|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|3.6||||0.074|TWO_SIDED|95.0|-0.3|7.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||7.6|-0.3|0.074
74089459|NCT02697773|147731645|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.3||0.7837|TWO_SIDED|95.0|0.48|1.73|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.73|0.48|0.7837
74089460|NCT02697773|147731645|SUPERIORITY||LS Mean Ratio|0.81|STANDARD_ERROR_OF_MEAN|0.26||0.5062|TWO_SIDED|95.0|0.43|1.52|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.52|0.43|0.5062
74089461|NCT02697773|147731645|SUPERIORITY||LS Mean Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.33||0.6821|TWO_SIDED|95.0|0.4|1.82|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.82|0.40|0.6821
74089462|NCT02697773|147731645|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.3||0.5032|TWO_SIDED|95.0|0.36|1.65|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.65|0.36|0.5032
74089463|NCT02697773|147731645|SUPERIORITY||LS Mean Ratio|1.24|STANDARD_ERROR_OF_MEAN|0.47||0.5796|TWO_SIDED|95.0|0.58|2.61|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||2.61|0.58|0.5796
74089464|NCT02697773|147731645|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.36||0.8725|TWO_SIDED|95.0|0.44|2.0|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||2.00|0.44|0.8725
74089465|NCT02409329|147731671|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.313||||0.0493|TWO_SIDED|95.0|-0.61|-0.017||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||-0.017|-0.610|.0493
74089466|NCT02409329|147731671|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.07||||0.26|TWO_SIDED|95.0|-0.38|0.24||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||0.240|-0.380|0.260
74089467|NCT02409329|147731672|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.406|||<|0.001|TWO_SIDED|95.0|0.196|0.615||A priori threshold p\<.05.|Wald statistic|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.615|0.196|<.001
73952963|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|1.9||||0.49|TWO_SIDED|95.0|-3.1|6.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||6.9|-3.1|0.49
73873096|NCT01965704|147289212|OTHER||Median Difference (Final Values)|-1.9||||0.07|TWO_SIDED|95.0|-4.0|0.2|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|Difference in length of stay as calculated with maximum length capped at 15 days.||0.2|-4.0|0.07
73873097|NCT01965704|147289213|OTHER||Mean Difference (Final Values)|-1.8||||0.31|TWO_SIDED|95.0|-8.8|2.7|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|||2.7|-8.8|0.31
73873098|NCT01526213|147289215|SUPERIORITY_OR_OTHER||Geometric Mean AUC Ratio (GFJ/mGFJ)|0.96||||0.78|TWO_SIDED|90.0|0.4|1.5|||t-test, 2 sided|||For juice comparisons, fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + grapefruit juice will be the reference standard (denominator).||1.5|0.4|0.78
73873099|NCT00799903|147289238|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.199|TWO_SIDED|95.1|0.85|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.03|0.85|0.199
73873100|NCT00799903|147289239|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.045|TWO_SIDED|95.0|0.82|1.0||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.00|0.82|0.045
73873101|NCT00799903|147289240|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.019|TWO_SIDED|95.0|0.84|0.98||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||0.98|0.84|0.019
74091669|NCT04168190|147737023|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|7.68|||<|0.001|TWO_SIDED|95.0|6.12|9.64|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||9.64|6.12|<0.001
73873102|NCT00799903|147289241|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.594|TWO_SIDED|95.0|0.83|1.11||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.11|0.83|0.594
73873103|NCT00799903|147289242|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.108|TWO_SIDED|95.0|0.77|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.03|0.77|0.108
73873104|NCT00799903|147289243|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.92|TWO_SIDED|95.0|0.81|1.27||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.27|0.81|0.920
73873105|NCT00799903|147289244|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.397|TWO_SIDED|95.0|0.88|1.05||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.05|0.88|0.397
73873106|NCT00799903|147289245|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.87|TWO_SIDED|95.0|0.9|1.13||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.13|0.90|0.870
73873107|NCT00740207|147289246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.7142|TWO_SIDED|95.0|-1.3|0.9|||t-test, 2 sided|||Paired t-test to compare difference between the investigational product's mean change from predose to postdose||0.9|-1.3|0.7142
73873108|NCT00740207|147289247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.1698|TWO_SIDED|95.0|-79.2|-0.8|||Fisher Exact|||Paired t-test to compare the difference in percentage between the portions of patients who had motion artifacts.||-0.8|-79.2|0.1698
73873109|NCT00740207|147289248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0||||1|TWO_SIDED|95.0|-28.6|8.6|||Fisher Exact|||Paired t-test to compare difference in percentage between the number of participants requiring repeat injections||8.6|-28.6|1.000
73873110|NCT00216671|147289298|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of early initiation was inferred if the upper 95% confidence boundary for the difference of change in PANSS total score from baseline in favor of the routine approach is less than 6.|Mean Difference (Net)|-1.13|STANDARD_ERROR_OF_MEAN|4.1||0.784|TWO_SIDED|95.0|-9.24|6.99||An ANCOVA model with treatment as factor was used. The comparison between the 2 treatment groups was performed based on the least-squares means obtained from the ANCOVA model.|ANCOVA|||Assuming a difference of 3 points in favor of early initiation of treatment with Risperdal Consta, a sample size of 87 subjects per treatment arm has a power of 80% to demonstrate non-inferiority at the 0.025-level (1-sided). It was expected that about 20% of randomized subjects had to be excluded from the per-protocol (PP) analysis. Therefore, 220 subjects were to be included.||6.99|-9.24|0.784
73873111|NCT00216671|147289301|SUPERIORITY_OR_OTHER|||||||0.8||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.800
73952964|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|4.4||||0.075|TWO_SIDED|95.0|-0.2|8.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||8.9|-0.2|0.075
73952965|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|10.2|||<|0.001|TWO_SIDED|95.0|4.3|16.2||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||16.2|4.3|<0.001
73952966|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|7.9||||0.045|TWO_SIDED|95.0|0.7|15.2||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||15.2|0.7|0.045
73952967|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|6.5||||0.1|TWO_SIDED|95.0|-1.1|14.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||14.0|-1.1|0.100
73952968|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|10.0||||0.004|TWO_SIDED|95.0|3.2|16.7||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||16.7|3.2|0.004
73952969|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|5.5||||0.25|TWO_SIDED|95.0|-2.9|14.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||14.0|-2.9|0.25
73952970|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|6.5||||0.14|TWO_SIDED|95.0|-2.0|15.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||15.0|-2.0|0.14
73952971|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|7.5||||0.002|TWO_SIDED|95.0|2.8|12.3||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||12.3|2.8|0.002
73952972|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|8.2||||0.008|TWO_SIDED|95.0|2.9|13.6||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||13.6|2.9|0.008
73952973|NCT02886728|147439427|SUPERIORITY||Difference in Response Rates|2.5||||0.47|TWO_SIDED|95.0|-3.9|8.9||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||8.9|-3.9|0.47
73952974|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|2.4|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.4|<0.001
73952975|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.55||0.001|TWO_SIDED|95.0|0.7|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.7|0.001
73952976|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.3|3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|1.3|<0.001
73952977|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|2.7|4.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.8|2.7|<0.001
73952978|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.66||0.008|TWO_SIDED|95.0|0.5|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|0.5|0.008
73952979|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.66||0.023|TWO_SIDED|95.0|0.2|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.2|0.023
73952980|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.59||0.003|TWO_SIDED|95.0|0.6|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.6|0.003
73952981|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.71||0.38|TWO_SIDED|95.0|-0.8|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.8|0.38
74033062|NCT00418834|147619096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.8||0.401||95.0|-0.9|2.1|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||2.1|-0.9|0.401
73873112|NCT00216671|147289301|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.||||<0.001
73952982|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.72||0.59|TWO_SIDED|95.0|-1.0|1.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.8|-1.0|0.59
73952983|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|1.6|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|1.6|<0.001
73952984|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.76||0.11|TWO_SIDED|95.0|-0.3|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.3|0.11
73952985|NCT02886728|147439429|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.76||0.071|TWO_SIDED|95.0|-0.17|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.17|0.071
73952986|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|1.6|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.6|<0.001
73952987|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.7||0.032|TWO_SIDED|95.0|0.1|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.1|0.032
73952988|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.0|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.0|<0.001
73952989|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.6||0.023|TWO_SIDED|95.0|0.2|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|0.2|0.023
73952990|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.74||0.065|TWO_SIDED|95.0|-0.1|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|-0.1|0.065
73980283|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|205.5|||||TWO_SIDED|95.0|70.04|602.78|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||602.78|70.04|
73980284|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|90.5|||||TWO_SIDED|95.0|40.28|203.27|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||203.27|40.28|
73980285|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|91.7|||||TWO_SIDED|95.0|36.25|232.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||232.13|36.25|
73980286|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|75.6|||||TWO_SIDED|95.0|47.32|120.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||120.91|47.32|
73980287|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.7|||||TWO_SIDED|95.0|5.21|14.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||14.40|5.21|
73980288|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|60.0|||||TWO_SIDED|95.0|31.06|115.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||115.92|31.06|
73980289|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|269.8|||||TWO_SIDED|95.0|105.09|692.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||692.60|105.09|
73980290|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|37.7|||||TWO_SIDED|95.0|10.85|131.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||131.09|10.85|
73980291|NCT00824850|147505641|SUPERIORITY_OR_OTHER||geometric mean fold rise|44.8|||||TWO_SIDED|95.0|21.31|94.01|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||94.01|21.31|
73980292|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.97|||||TWO_SIDED|95.0|1.31|2.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.95|1.31|
73980293|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.95|||||TWO_SIDED|95.0|1.78|4.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.90|1.78|
73980294|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.85|||||TWO_SIDED|95.0|1.25|2.75|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.75|1.25|
73980295|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.24|||||TWO_SIDED|95.0|1.11|4.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.53|1.11|
74089468|NCT02409329|147731672|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.21||||0.003|TWO_SIDED|95.0|-0.031|0.45||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||0.450|-0.031|0.003
74089469|NCT02409329|147731673|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.54||||0.376|TWO_SIDED|95.0|-0.012|1.09||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||1.090|-0.012|0.376
74091670|NCT04168190|147737023|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|3.29|||<|0.001|TWO_SIDED|95.0|2.6|4.17|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15C. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||4.17|2.60|<0.001
73873113|NCT00216671|147289301|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.||||<0.001
73873114|NCT00216671|147289302|SUPERIORITY_OR_OTHER|||||||0.798||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.798
73873115|NCT00216671|147289302|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
73952991|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.74||0.15|TWO_SIDED|95.0|-0.4|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|-0.4|0.15
73952992|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.64||0.73|TWO_SIDED|95.0|-1.0|1.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.5|-1.0|0.73
73952993|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.78||0.37|TWO_SIDED|95.0|-0.8|2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.2|-0.8|0.37
73952994|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.78||0.83|TWO_SIDED|95.0|-1.7|1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.4|-1.7|0.83
73952995|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.66||0.073|TWO_SIDED|95.0|-0.1|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|-0.1|0.073
73952996|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.8||0.09|TWO_SIDED|95.0|-0.2|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.2|0.090
73952997|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.81||0.68|TWO_SIDED|95.0|-1.9|1.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.2|-1.9|0.68
73952998|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.67||0.3|TWO_SIDED|95.0|-0.6|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.6|0.30
74033063|NCT00418834|147619097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|1.1|4.2|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||4.2|1.1|<0.001
73873116|NCT00216671|147289302|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
73873117|NCT00216671|147289303|SUPERIORITY_OR_OTHER|||||||0.519||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.519
73952999|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.82||0.69|TWO_SIDED|95.0|-1.3|1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.9|-1.3|0.69
73873118|NCT00216671|147289303|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
73953000|NCT02886728|147439431|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.82||0.95|TWO_SIDED|95.0|-1.7|1.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.5|-1.7|0.95
73953001|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|TWO_SIDED|95.0|2.1|4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.4|2.1|<0.001
73953002|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.1|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.1|<0.001
73953003|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|1.3|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|1.3|<0.001
73980296|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.63|||||TWO_SIDED|95.0|0.38|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.05|0.38|
73980297|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.5|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.62|0.50|
73980298|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.83|||||TWO_SIDED|95.0|0.48|1.43|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.43|0.48|
73980299|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.7|||||TWO_SIDED|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.00|0.96|
73980300|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.25|||||TWO_SIDED|95.0|0.79|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.96|0.79|
73980301|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.54|1.52|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.52|0.54|
74091671|NCT04168190|147737023|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|8.65|||<|0.001|TWO_SIDED|95.0|7.19|10.41|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 16F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||10.41|7.19|<0.001
73980302|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.81|||||TWO_SIDED|95.0|0.98|3.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.34|0.98|
73980303|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.72|||||TWO_SIDED|95.0|1.05|2.83|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.83|1.05|
73980304|NCT00824850|147505642|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.06|||||TWO_SIDED|95.0|0.67|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.66|0.67|
74089470|NCT02409329|147731673|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.278||||0.434|TWO_SIDED|95.0|-0.319|0.875||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.875|-0.319|0.434
73873119|NCT00216671|147289303|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
73953004|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.0|3.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.5|1.0|<0.001
73953005|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.78||0.13|TWO_SIDED|95.0|-0.4|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.4|0.13
73953006|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.79||0.032|TWO_SIDED|95.0|0.1|3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.2|0.1|0.032
73953007|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.67||0.028|TWO_SIDED|95.0|0.2|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.2|0.028
73953008|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.81||0.15|TWO_SIDED|95.0|-0.4|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.4|0.15
73980305|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.18|||||TWO_SIDED|95.0|1.26|3.79|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.79|1.26|
73953009|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.81||0.41|TWO_SIDED|95.0|-0.9|2.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.3|-0.9|0.41
73980306|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|3.13|||||TWO_SIDED|95.0|1.84|5.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||5.32|1.84|
73873120|NCT00216671|147289303|SUPERIORITY_OR_OTHER|||||||0.721||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.721
73873121|NCT00216671|147289303|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
73953010|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.71||0.017|TWO_SIDED|95.0|0.3|3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.1|0.3|0.017
73953011|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.86||0.27|TWO_SIDED|95.0|-0.7|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|-0.7|0.27
74033064|NCT00418834|147619098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-10.7|-7.3|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.3|-10.7|<0.001
73953012|NCT02886728|147439433|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.87||0.15|TWO_SIDED|95.0|-0.5|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.5|0.15
73953013|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|6.0|12.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|6.0|<0.001
73980307|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.68|||||TWO_SIDED|95.0|1.13|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.51|1.13|
73980308|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.96|||||TWO_SIDED|95.0|0.95|4.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.07|0.95|
73980309|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.51|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.56|0.51|
73980310|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.58|||||TWO_SIDED|95.0|0.93|2.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.66|0.93|
73980311|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.62|||||TWO_SIDED|95.0|0.97|2.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.73|0.97|
73980312|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.41|||||TWO_SIDED|95.0|0.83|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.39|0.83|
74033065|NCT00418834|147619099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-6.8|-2.4|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-2.4|-6.8|<0.001
74033066|NCT00418834|147619100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-17.0|-12.2|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-12.2|-17.0|<0.001
74089471|NCT02409329|147731674|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.399||||0.0012|TWO_SIDED|95.0|0.16|0.637||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations||0.637|0.160|0.0012
73873122|NCT00216671|147289303|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
73953014|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.6||0.006|TWO_SIDED|95.0|1.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|1.0|0.006
73953015|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|3.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|3.0|<0.001
73953016|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|<0.001
73953017|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.8||0.089|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|-0.0|0.089
73980313|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.44|||||TWO_SIDED|95.0|0.89|2.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.34|0.89|
73980314|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.06|||||TWO_SIDED|95.0|0.68|1.64|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.64|0.68|
73980315|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.88|||||TWO_SIDED|95.0|1.05|3.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.35|1.05|
73980316|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.48|||||TWO_SIDED|95.0|0.9|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.44|0.90|
73980317|NCT00824850|147505643|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.11|||||TWO_SIDED|95.0|0.75|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.66|0.75|
73980318|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.5|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.17|0.50|
73980319|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.7|1.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.73|0.70|
73980320|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.61|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.15|0.61|
73980321|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.56|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.25|0.56|
73980322|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.51|1.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.40|0.51|
74033067|NCT00418834|147619101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-10.1|-3.7|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-3.7|-10.1|<0.001
74033068|NCT00418834|147619102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-11.6|-7.5|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.5|-11.6|<0.001
73873123|NCT00226811|147289425|SUPERIORITY_OR_OTHER||CBR rate (percentage)|7.7||||||95.0|2.9|16.0|||||Clinical benefit response rate: percent of patients with confirmed complete response, confirmed partial response or stable disease for at least 24 wks according to Response Evaluation Criteria in Solid Tumors, relative to total treated patients|||16.0|2.9|
73873124|NCT00226811|147289430|SUPERIORITY_OR_OTHER||OR rate (percentage)|2.6||||||95.0|0.3|9.0|||||Percentage of patients with confirmed complete response or confirmed partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST), relative to the total number of treated patients.|||9.0|0.3|
73953018|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.9||0.18|TWO_SIDED|95.0|-1.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-1.0|0.18
73873125|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
73953019|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.5||0.003|TWO_SIDED|95.0|1.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|1.0|0.003
73953020|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.8||0.049|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|0.0|0.049
73953021|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.8||0.84|TWO_SIDED|95.0|-4.0|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-4.0|0.84
73953022|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|2.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|2.0|<0.001
73953023|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.0||0.078|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|-0.0|0.078
73953024|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.39|TWO_SIDED|95.0|-2.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-2.0|0.39
73980323|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.32|1.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.12|0.32|
74091672|NCT04168190|147737023|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|7.83|||<|0.001|TWO_SIDED|95.0|6.2|9.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model||9.90|6.20|<0.001
73873126|NCT01128426|147289439|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873127|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .99
73873128|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73873129|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .20
73873130|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
74033069|NCT00418834|147619103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.7|-2.9|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-2.9|-7.7|<0.001
74033070|NCT00418834|147619104|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-15.3|-10.5|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-10.5|-15.3|<0.001
74033071|NCT00418834|147619105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-9.8|-3.6|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-3.6|-9.8|<0.001
74033072|NCT00418834|147619106|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8||||0.534||95.0|-11.9|6.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."|||6.4|-11.9|0.534
74033073|NCT00418834|147619107|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0||||0.09||95.0|-15.6|1.6|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."|||1.6|-15.6|0.090
74033074|NCT01953328|147619108|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-73.97|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-78.54|-69.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.41|-78.54|<0.001
74089472|NCT02409329|147731674|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.152||||0.003|TWO_SIDED|95.0|-0.121|0.426||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.426|-0.121|0.003
74091673|NCT04168190|147737023|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|5.61|||<|0.001|TWO_SIDED|95.0|4.53|6.94|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||6.94|4.53|<0.001
74091674|NCT04168190|147737023|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|23.99|||<|0.001|TWO_SIDED|95.0|19.35|29.74|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 24F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||29.74|19.35|<0.001
74033075|NCT01953328|147619108|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-72.89|STANDARD_ERROR_OF_MEAN|2.18|<|0.001|TWO_SIDED|95.0|-77.22|-68.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-68.57|-77.22|<0.001
74033076|NCT01953328|147619108|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.41|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|-81.21|-67.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-67.61|-81.21|<0.001
74033077|NCT01953328|147619108|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.27|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-78.93|-69.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.60|-78.93|<0.001
74033078|NCT01953328|147619109|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.85|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-80.22|-69.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.47|-80.22|<0.001
73953025|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.7||0.004|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|0.004
73953026|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.1||0.45|TWO_SIDED|95.0|-3.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-3.0|0.45
73953027|NCT02886728|147439436|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.1||0.85|TWO_SIDED|95.0|-4.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|-4.0|0.85
73953028|NCT02724020|147439469|SUPERIORITY||Hazard Ratio (HR)|1.33|||=|0.388|TWO_SIDED|95.0|0.75|2.36|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.36|0.75|=0.388
73953029|NCT02724020|147439469|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.667|TWO_SIDED|95.0|0.75|2.52|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.52|0.75|0.667
73953030|NCT02724020|147439471|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.212|TWO_SIDED|95.0|0.89|3.49|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||3.49|0.89|0.212
73980324|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.38|0.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||0.85|0.38|
73980325|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.75|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.22|0.75|
73980326|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.82|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.61|0.82|
73980327|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.36|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.13|0.36|
73980328|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.55|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.39|0.55|
74089473|NCT02409329|147731675|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.061||||0.632|TWO_SIDED|95.0|-0.218|0.095||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.095|-0.218|0.632
74091675|NCT04168190|147737023|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|10.13|||<|0.001|TWO_SIDED|95.0|8.32|12.33|||P-value was estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 31. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||12.33|8.32|<0.001
73953031|NCT02724020|147439471|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.546|TWO_SIDED|95.0|0.77|2.98|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.98|0.77|0.546
73953032|NCT02724020|147439472|SUPERIORITY||Hazard Ratio (HR)|1.57|||=|0.156|TWO_SIDED|95.0|0.81|3.05|||Log Rank||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the International Metastatic Renal Cell Carcinoma Database Consortium risk category. A hazard ratio \< 1 indicates an advantage compared to Everolimus.|||3.05|0.81|=0.156
73953033|NCT02724020|147439472|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.667|TWO_SIDED|95.0|0.72|2.79|||Log Rank||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the International Metastatic Renal Cell Carcinoma Database Consortium risk category. A hazard ratio \< 1 indicates an advantage compared to Everolimus.|||2.79|0.72|0.667
73953034|NCT02724020|147439473|SUPERIORITY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.08|2.22|||||Odds ratio and 95% CI were obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|As prespecified in the protocol, the statistical analysis was performed between arms - Arm A: Single-agent Everolimus 10 mg QD and Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD only.|As prespecified in protocol, the statistical analysis was performed between arms - Arm A: Single-agent Everolimus 10 mg QD and Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD only for this outcome measure.|2.22|0.08|
73953035|NCT02724020|147439474|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.24|1.69|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.69|0.24|
73953036|NCT02724020|147439474|SUPERIORITY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.28|2.21|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||2.21|0.28|
73953037|NCT02724020|147439475|SUPERIORITY||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.16|1.38|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.38|0.16|
73953038|NCT02724020|147439475|SUPERIORITY||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.2|1.8|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.80|0.20|
73953039|NCT03890120|147439481|SUPERIORITY||Difference in Percentages|-1.4||||0.4186|TWO_SIDED|95.0|-15.2|12.3|||Mantel Haenszel||The difference of cilofexor and placebo,95% confidence interval(CI),and P value(1-sided)were obtained by the stratum-adjusted Mantel-Haenszel (MH) method,with baseline ursodeoxycholic acid(UDCA)use and Ludwig fibrosis stage as stratification factors.|||12.3|-15.2|0.4186
73980329|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.73|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.70|0.73|
73980330|NCT00824850|147505644|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.5|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.63|0.50|
73980331|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.35|1.27|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.27|0.35|
74033079|NCT01953328|147619109|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-69.91|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|-74.6|-65.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.23|-74.60|<0.001
74033080|NCT01953328|147619109|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-78.85|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-83.55|-68.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-68.15|-83.55|<0.001
74089474|NCT02409329|147731675|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.005||||0.572|TWO_SIDED|95.0|-0.202|1.1||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||1.100|-0.202|0.572
73953040|NCT03890120|147439486|SUPERIORITY||Difference in Least Squares Mean (LSM)|-4.0||||0.3884|TWO_SIDED|95.0|-28.0|21.0|||ANCOVA||The LSM,95% CI and P-value(1-sided) were obtained by an analysis of covariance(ANCOVA)model with change at Week 96 as dependent variable,baseline value of outcome measure,baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||21|-28|0.3884
73953041|NCT03890120|147439487|SUPERIORITY||Difference in LSM|-9.0||||0.039|TWO_SIDED|95.0|-20.0|1.0|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||1|-20|0.0390
73953042|NCT03890120|147439488|SUPERIORITY||Difference in LSM|-2.6||||0.2845|TWO_SIDED|95.0|-11.6|6.4|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||6.4|-11.6|0.2845
73953043|NCT03890120|147439489|SUPERIORITY||Difference in Percentages|4.1||||0.1978|TWO_SIDED|95.0|-5.3|13.5|||Mantel Haenszel||The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.|||13.5|-5.3|0.1978
73953044|NCT03890120|147439490|SUPERIORITY||Difference in Percentages|8.9||||0.0797|TWO_SIDED|95.0|-3.5|21.2|||Mantel Haenszel||The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.|||21.2|-3.5|0.0797
73873131|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
73873132|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873133|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .03
73953045|NCT03890120|147439491|SUPERIORITY||Difference in LSM|1.0||||0.7275|TWO_SIDED|95.0|-1.0|3.0|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||3|-1|0.7275
73980332|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.77|2.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.05|0.77|
73980333|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.54|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.44|0.54|
73980334|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.38|0.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||0.95|0.38|
74033081|NCT01953328|147619109|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-66.87|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-72.88|-60.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.87|-72.88|<0.001
74089475|NCT02409329|147731676|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|369.0||||0.703|TWO_SIDED|95.0|-142.0|881.0||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||881|-142|0.703
73953046|NCT03890120|147439492|SUPERIORITY||Difference in LSM|-0.03||||0.3636|TWO_SIDED|95.0|-0.2|0.14|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||0.14|-0.20|0.3636
74091676|NCT04168190|147737023|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|18.29|||<|0.001|TWO_SIDED|95.0|15.59|21.45|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 35B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||21.45|15.59|<0.001
73980335|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.64|1.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.91|0.64|
73980336|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.28|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.62|0.28|
73873134|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73873135|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873136|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873137|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
73873138|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
73953047|NCT03890120|147439493|SUPERIORITY||Difference in LSM|-0.3||||0.3595|TWO_SIDED|95.0|-2.2|1.5|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||1.5|-2.2|0.3595
73980337|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.4|||||TWO_SIDED|95.0|0.68|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.81|0.68|
73873139|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
73980338|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.53|1.77|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.77|0.53|
73980339|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.69|1.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.81|0.69|
73980340|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.32|1.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.85|0.32|
73980341|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.4|||||TWO_SIDED|95.0|0.8|2.36|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.36|0.80|
73980342|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.65|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.44|0.65|
73980343|NCT00824850|147505645|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.46|1.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.57|0.46|
73980344|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-10.2|
73980345|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
73980346|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73980347|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73980348|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980349|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
74033082|NCT01953328|147619110|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-89.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-98.4|-80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-80.2|-98.4|<0.001
74033083|NCT01953328|147619110|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-86.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-95.1|-77.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-77.5|-95.1|<0.001
73873140|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873141|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
73980350|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
73980351|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73980352|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980353|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|3.1|||||TWO_SIDED|95.0|-9.3|17.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.0|-9.3|
73980354|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73980355|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
73980356|NCT00824850|147505648|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980357|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
73980358|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-10.2|
73980359|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73980360|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.5|
73980361|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
73980362|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.1|10.5||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.5|-10.1|
73980363|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||16.6|-9.1|
73980364|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
73980365|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
73980366|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|3.3|||||TWO_SIDED|95.0|-8.6|17.2||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.2|-8.6|
74089476|NCT02409329|147731676|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|26.0||||0.465|TWO_SIDED|95.0|-459.0|511.0||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||511|-459|0.465
74089477|NCT02409329|147731677|SUPERIORITY|Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.75|||||TWO_SIDED|95.0|-1.38|-0.12|||||6-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||-0.12|-1.38|
73980367|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980368|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.7|10.6||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-9.7|
73980369|NCT00824850|147505649|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
73980370|NCT02144285|147505662|SUPERIORITY_OR_OTHER||Absolute Bioavailability|0.45|||||TWO_SIDED|90.0|0.34|0.6||||||||0.60|0.34|
73980371|NCT03659136|147505669|OTHER||Hazard Ratio (HR)|1.19||||0.6534|TWO_SIDED|95.0|0.55|2.59|||Log-rank test|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior (CDK) 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+Everolimus+Exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||2.59|0.55|0.6534
73980372|NCT03659136|147505670|OTHER||Hazard Ratio (HR)|0.5||||0.1797|TWO_SIDED|95.0|0.18|1.4|||Log rank test|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+Everolimus+Exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||1.40|0.18|0.1797
73980373|NCT03659136|147505671|OTHER||Odds Ratio (OR)|1.31||||0.4932|TWO_SIDED|95.0|0.6|2.86|||Regression, Logistic|Logistic regression model adjusted for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+everolimus+exemestane. An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||2.86|0.60|0.4932
73980374|NCT03659136|147505673|OTHER||Odds Ratio (OR)|1.2||||0.7759|TWO_SIDED|95.0|0.34|4.43|||Regression, Logistic|Logistic regression model adjusted for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+everolimus+exemestane. An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||4.43|0.34|0.7759
73980375|NCT03659136|147505674|OTHER||Cox Proportional Hazard|0.97||||0.9279|TWO_SIDED|95.0|0.54|1.76|||Log Rank|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior CDK4/6 inhibitor treatment and menopause status.|Comparison versus Placebo+everolimus+exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||1.76|0.54|0.9279
74089478|NCT02409329|147731677|SUPERIORITY|Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.31|||||TWO_SIDED|95.0|-1.0|0.39|||||12-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.39|-1.00|
73873142|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
73980376|NCT03786471|147505681|SUPERIORITY||marginal difference of LS means|0.3||||0.33|TWO_SIDED|97.5|-0.18|0.78||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.78|-0.18|0.33
73980377|NCT03786471|147505681|SUPERIORITY||marginal difference of LS means|-0.62||||0.33|TWO_SIDED|97.5|-1.61|0.37||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.37|-1.61|0.33
73980378|NCT03786471|147505681|SUPERIORITY||marginal difference of LS means|-0.33||||0.46|TWO_SIDED|97.5|-1.32|0.67||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.67|-1.32|0.46
73980379|NCT03786471|147505688|SUPERIORITY||marginal difference of LS means|0.25||||0.54|TWO_SIDED|97.5|-0.16|0.66||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.66|-0.16|0.54
73980380|NCT03786471|147505688|SUPERIORITY||marginal difference of LS means|-0.1||||0.79|TWO_SIDED|97.5|-0.94|0.74||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.74|-0.94|0.79
73980381|NCT03786471|147505688|SUPERIORITY||marginal difference of LS means|0.14||||0.79|TWO_SIDED|97.5|-0.7|0.99||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.99|-0.70|0.79
73980382|NCT03786471|147505695|SUPERIORITY||marginal difference of LS means|0.52||||0.48|TWO_SIDED|95.0|-0.09|1.13||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.13|-.09|0.48
73980383|NCT03786471|147505695|SUPERIORITY||marginal difference of LS means|-0.81||||0.62|TWO_SIDED|95.0|-2.07|0.45||Alpha = 0.05; Hochberg correction for three pairwise comparisons \*three secondary outcomes|Mixed Models Analysis|||||0.45|-2.07|0.62
73980384|NCT03786471|147505695|SUPERIORITY||marginal difference of LS means|-1.33||||0.23|TWO_SIDED|95.0|-2.58|-0.07||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||-0.07|-2.58|0.23
73980385|NCT03786471|147505702|SUPERIORITY||marginal difference of LS means|0.28||||0.23|TWO_SIDED|95.0|0.01|0.54||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||.54|.01|0.23
73873143|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
73980386|NCT03786471|147505702|SUPERIORITY||marginal difference of LS means|0.01||||0.98|TWO_SIDED|95.0|-0.53|0.55||Alpha = 0.05; Hochberg correction for three pairwise comparisons \*three secondary outcomes|Mixed Models Analysis|||||.55|-.53|.98
73980387|NCT03786471|147505702|SUPERIORITY||marginal difference of LS means|-0.27||||0.65|TWO_SIDED|95.0|-0.81|0.27||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||0.27|-0.81|0.65
73980388|NCT03786471|147505707|SUPERIORITY||marginal difference of LS means|-0.16||||0.62|TWO_SIDED|95.0|-0.37|0.06||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||0.06|-0.37|0.62
73980389|NCT03786471|147505707|SUPERIORITY||marginal difference of LS means|0.7||||0.01|TWO_SIDED|95.0|0.26|1.14||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.14|0.26|0.01
73980390|NCT03786471|147505707|SUPERIORITY||marginal difference of LS means|0.85||||0.001|TWO_SIDED|95.0|0.42|1.29||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.29|0.42|0.001
73980391|NCT03346200|147505730|NON_INFERIORITY|The non-inferiority margin was based on the proportion of responders and was set to 17%. That is, we defined non-inferiority to mean that the proportion of responders in the non-referent study arms is not less than one third of the responders in the 20 mg group (50% minus 33% = 17%)|Median Difference (Final Values)|52.5|||<|0.01|TWO_SIDED|97.5|41.9|100.0|||one-sided Wald tests|P-values were corrected for multiple comparisons using the Holm-Bonferroni method. Non-inferiority p-values were declared if less than a=0.025||||100|41.9|<0.01
73980392|NCT01513447|147505733|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
73980393|NCT01513447|147505734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|102.0||||0.29|TWO_SIDED|95.0|-230.0|171.0|||Wilcoxon (Mann-Whitney)|||||171|-230|0.29
73980394|NCT01276509|147505735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.05|STANDARD_ERROR_OF_MEAN|0.121||0.3393|TWO_SIDED|90.0|-0.149|0.249|||Mixed Models Analysis|||Difference from placebo at Week 8||0.249|-0.149|0.3393
73873144|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
74089479|NCT02409329|147731677|SUPERIORITY|Testing superiority of REACH\_FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.65|||||TWO_SIDED|95.0|-1.26|-0.05|||||6-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||-0.05|-1.26|
73980395|NCT01276509|147505735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.124|STANDARD_ERROR_OF_MEAN|0.117||0.1433|TWO_SIDED|90.0|-0.068|0.316|||Mixed Models Analysis|||Difference from placebo at Week 8||0.316|-0.068|0.1433
73980396|NCT01276509|147505735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.15|STANDARD_ERROR_OF_MEAN|0.113||0.0922|TWO_SIDED|90.0|-0.036|0.335|||Mixed Models Analysis|||Difference from placebo at Week 8||0.335|-0.036|0.0922
73980397|NCT01276509|147505735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.034|STANDARD_ERROR_OF_MEAN|0.117||0.3864|TWO_SIDED|90.0|-0.158|0.225|||Mixed Models Analysis|||Difference from placebo at Week 12||0.225|-0.158|0.3864
73980398|NCT01276509|147505735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.061|STANDARD_ERROR_OF_MEAN|0.117||0.3005|TWO_SIDED|90.0|-0.131|0.253|||Mixed Models Analysis|||Difference from placebo at Week 12||0.253|-0.131|0.3005
73980399|NCT01276509|147505735|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-0.011|STANDARD_ERROR_OF_MEAN|0.114||0.5385|TWO_SIDED|90.0|-0.198|0.176|||Mixed Models Analysis|||Difference from placebo at Week 12||0.176|-0.198|0.5385
73980400|NCT01276509|147505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.124|STANDARD_ERROR_OF_MEAN|0.107||0.1234|TWO_SIDED|90.0|-0.052|0.299|||Mixed Models Analysis|||Difference from placebo at week 8||0.299|-0.052|0.1234
73980401|NCT01276509|147505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.071|STANDARD_ERROR_OF_MEAN|0.099||0.2378|TWO_SIDED|90.0|-0.092|0.234|||Mixed Models Analysis|||Difference from placebo at week 8||0.234|-0.092|0.2378
73980402|NCT01276509|147505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.102|STANDARD_ERROR_OF_MEAN|0.1||0.1529|TWO_SIDED|90.0|-0.062|0.266|||Mixed Models Analysis|||Difference from placebo at week 8||0.266|-0.062|0.1529
73980403|NCT01276509|147505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.038|STANDARD_ERROR_OF_MEAN|0.112||0.3661|TWO_SIDED|90.0|-0.146|0.222|||Mixed Models Analysis|||Difference from placebo at week 12||0.222|-0.146|0.3661
73980404|NCT01276509|147505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.055|STANDARD_ERROR_OF_MEAN|0.116||0.3169|TWO_SIDED|90.0|-0.136|0.246|||Mixed Models Analysis|||Difference from placebo at week 12||0.246|-0.136|0.3169
73980405|NCT01276509|147505738|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.066|STANDARD_ERROR_OF_MEAN|0.111||0.2755|TWO_SIDED|90.0|-0.116|0.248|||Mixed Models Analysis|||Difference from placebo at week 12||0.248|-0.116|0.2755
73980406|NCT00413283|147505751|SUPERIORITY_OR_OTHER|||||||0.972|||||||Satterthwaite t-test|||||||0.972
73980407|NCT00413283|147505751|SUPERIORITY_OR_OTHER|||||||0.725|||||||Satterthwaite t-test|||||||0.725
73873145|NCT01128426|147289439|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873146|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
73980408|NCT00413283|147505751|SUPERIORITY_OR_OTHER|||||||0.312|||||||Satterthwaite t-test|||||||0.312
73980409|NCT00413283|147505752|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
73980410|NCT00413283|147505752|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
73980411|NCT00413283|147505752|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
73980412|NCT00413283|147505753|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
73980413|NCT00413283|147505753|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
73980414|NCT00413283|147505753|SUPERIORITY_OR_OTHER|||||||0.342|||||||Fisher Exact|||||||0.342
73873147|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873148|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
73980415|NCT00413283|147505754|SUPERIORITY_OR_OTHER|||||||0.454|||||||Satterthwaite t-test|||||||0.454
73980416|NCT00413283|147505754|SUPERIORITY_OR_OTHER|||||||0.101|||||||Satterthwaite t-test|||||||0.101
73980417|NCT00413283|147505754|SUPERIORITY_OR_OTHER|||||||0.199|||||||Satterthwaite t-test|||||||0.199
73980418|NCT00413283|147505755|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
73980419|NCT00413283|147505755|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
73980420|NCT00413283|147505755|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
73980421|NCT01377844|147505757|SUPERIORITY||Difference of LS Means|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.53||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||||-0.53|-1.06|< 0.0001
73873149|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873150|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873151|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873152|NCT01128426|147289439|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873153|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873154|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
74089480|NCT02409329|147731677|SUPERIORITY|Testing superiority of REACH+FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.31|||||TWO_SIDED|95.0|-0.96|0.51|||||12-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.51|-0.96|
73873155|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
73873156|NCT01128426|147289439|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873157|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
73873158|NCT01128426|147289439|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873159|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873160|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
73873161|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
73873162|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
73873163|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
73873164|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73873165|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
73873166|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
73873167|NCT01128426|147289439|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873168|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873169|NCT01128426|147289439|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873170|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
73873171|NCT01128426|147289440|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873172|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873173|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873174|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73873175|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873176|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
73873177|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
73873178|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873179|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
73953048|NCT03785340|147439513|SUPERIORITY|"The endpoints were tested in a fixed sequence, proceeding to the next endpoint until a p-value \>0.05 was found:~1. Change from baseline to 4 weeks (Day 28) in SANDE score~2. Change from baseline to 4 weeks (Day 28) in Lissamine Green conjunctival staining scores~3. Change from baseline to 2 weeks (Day 14) in SANDE score~4. Change from baseline to 2 weeks (Day 14) in Lissamine Green conjunctival staining scores"|Least squares mean difference|-0.844||||0.739|TWO_SIDED|95.0|-5.823|4.134|||Mixed Model Repeated Measures Analysis||Change from baseline to 4 weeks (Day 28) in SANDE score; OCU-310 vs. Placebo|Four endpoints (two primary and two secondary) were to be tested in a fixed sequence, proceeding to the next endpoint until a p-value \>0.05 was found. The analysis of the four outcomes employed a repeated measures mixed model with mean change from baseline score at the stated time point as the response with baseline score as a covariate and treatment, visit, and their interaction as fixed effects. The least squares mean difference (OCU 310 - placebo) at the stated time point was tested.||4.134|-5.823|0.739
73953049|NCT02923895|147439520|SUPERIORITY|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.|Mean Difference (Net)|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.128||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-1.128|-1.500|<.0001
74089481|NCT02149121|147731679|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|97.07|||||TWO_SIDED|90.0|88.08|106.99|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using analysis of covariance (ANCOVA) model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||106.99|88.08|
73873180|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
73873181|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
73953050|NCT01670500|147439532|OTHER||Risk Ratio (RR)|0.7|||||TWO_SIDED|90.0|0.39|1.2|||||The risk ratio is comparing cisplatin to doxorubicin-cyclophosphamide (AC)|||1.2|0.39|
73953051|NCT01670500|147439533|OTHER||Risk Ratio (RR)|0.73|||||TWO_SIDED|90.0|0.5|1.1|||||The risk ratio is comparing cisplatin to doxorubicin-cyclophosphamide (AC)|||1.1|.5|
73953052|NCT04320615|147439537|OTHER||Median Difference (Final Values)|-1.0||||0.36|TWO_SIDED|95.0|-2.5|0.0|||Van Elteren Test|||||0.0|-2.5|0.3600
73980422|NCT01377844|147505758|SUPERIORITY||Difference of LS Means|-5.53|||<|0.0001|TWO_SIDED|95.0|-8.02|-3.04||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline systolic BP, baseline HbA1c category, site, age category, gender and race||||-3.04|-8.02|< 0.0001
73873182|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
73873183|NCT01128426|147289440|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873184|NCT01128426|147289440|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873185|NCT01128426|147289440|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73953053|NCT04320615|147439538|OTHER||Hazard Ratio (HR)|1.448||||0.0443|TWO_SIDED|95.0|1.01|2.08|||Log Rank|||||2.08|1.01|0.0443
73953054|NCT04320615|147439539|OTHER||Hazard Ratio (HR)|1.263||||0.082|TWO_SIDED|95.0|0.97|1.64|||Log Rank|||||1.64|0.97|0.0820
73953055|NCT04320615|147439540|OTHER||Hazard Ratio (HR)|1.35||||0.037|TWO_SIDED|95.0|1.02|1.79|||Log Rank|||||1.79|1.02|0.0370
73953056|NCT04320615|147439541|OTHER||Weighted % difference|-6.2||||0.0996|TWO_SIDED|95.0|-13.8|1.4|||Cochran-Mantel-Haenszel|||||1.4|-13.8|0.0996
73953057|NCT04320615|147439541|OTHER||Weighted % difference|-8.9||||0.1355|TWO_SIDED|95.0|-20.7|3.0|||Cochran-Mantel-Haenszel|||||3.0|-20.7|0.1355
73953058|NCT04320615|147439542|OTHER||Median Difference (Final Values)|5.5||||0.3202|TWO_SIDED|95.0|-2.8|13.0|||Van Elteren test|||||13.0|-2.8|0.3202
73953059|NCT04320615|147439543|OTHER||Weighted % difference|-5.7||||0.1514|TWO_SIDED|95.0|-13.7|2.2|||Cochran-Mantel-Haenszel|||||2.2|-13.7|0.1514
73953060|NCT04320615|147439543|OTHER||Weighted % difference|-14.8||||0.029|TWO_SIDED|95.0|-28.6|-1.0|||Cochran-Mantel-Haenszel|||||-1.0|-28.6|0.0290
73953061|NCT04320615|147439544|OTHER||Median Difference (Final Values)|-5.8||||0.0454|TWO_SIDED|95.0|-15.0|2.9|||Van Elteren test|||||2.9|-15.0|0.0454
74089482|NCT02149121|147731679|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|94.18|||||TWO_SIDED|90.0|85.4|103.86|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||103.86|85.40|
74089483|NCT02149121|147731679|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|103.07|||||TWO_SIDED|90.0|93.32|113.85|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||113.85|93.32|
74089484|NCT02149121|147731680|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|95.81|||||TWO_SIDED|90.0|87.39|105.04|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||105.04|87.39|
73873186|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
73953062|NCT04320615|147439545|OTHER||Median Difference (Final Values)|-1.0||||0.0548|TWO_SIDED|95.0|-2.0|0.5|||Van Elteren test|||||0.5|-2.0|0.0548
73873187|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73873188|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
73873189|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
73873190|NCT01128426|147289440|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73953063|NCT04320615|147439546|OTHER||Hazard Ratio (HR)|0.79||||0.1627|TWO_SIDED|95.0|0.57|1.1|||Log Rank|||||1.10|0.57|0.1627
73953064|NCT04320615|147439547|OTHER||Weighted % difference|0.3||||0.941|TWO_SIDED|95.0|-7.6|8.2|||Cochran-Mantel-Haenszel|||||8.2|-7.6|0.9410
73953065|NCT04320615|147439548|OTHER||Hazard Ratio (HR)|1.307||||0.0528|TWO_SIDED|95.0|1.0|1.72|||Log Rank|||||1.72|1.00|0.0528
73953066|NCT04320615|147439549|OTHER||Median Difference (Final Values)|-1.5||||0.0477|TWO_SIDED|95.0|-9.0|0.5|||Van Elteren test|||||0.5|-9.0|0.0477
73953067|NCT01449721|147439550|SUPERIORITY_OR_OTHER|||||||0.064|||||||2-sample z-test|z-test for differences in proportions||Null hypothesis: In patients with moderate severity sepsis, there is no change in the incidence of organ dysfunction within 72 hours associated with the use of an empiric fluid resuscitation algorithm.||||0.064
73953068|NCT02107443|147439573|SUPERIORITY||Mean Difference (Final Values)|3.59|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.0001
73953069|NCT02107443|147439574|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.041|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.041
73953070|NCT02107443|147439576|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.03|TWO_SIDED|95.0|0.12|1.98|||Mixed Models Analysis|The above p-values is for 4-6 weeks.|The above values are for 4-6 weeks.|||1.98|0.12|0.03
73953071|NCT02107443|147439576|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.08|TWO_SIDED|95.0|-0.11|1.77|||Mixed Models Analysis|The above p-value is for is for 3 months.|The above values are for 3 months|||1.77|-0.11|.08
73953072|NCT02107443|147439576|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.2|TWO_SIDED|95.0|-0.36|1.59|||Mixed Models Analysis|The above p-value is for 6 months|The above values are for 6 months.|||1.59|-0.36|0.20
73953073|NCT00729690|147439602|SUPERIORITY_OR_OTHER|||||||0.4742||95.0|||||ANOVA|||For 1st 24 hours NRS AUC Pain scores||||0.4742
74033084|NCT01953328|147619110|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.7|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-75.3|-62.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.1|-75.3|<0.001
73953074|NCT00729690|147439603|SUPERIORITY_OR_OTHER|||||||0.7596||95.0|||||ANOVA|||||||0.7596
73953075|NCT00729690|147439604|SUPERIORITY_OR_OTHER|||||||0.4321||95.0|||||ANOVA|||||||0.4321
73953076|NCT00729690|147439605|SUPERIORITY_OR_OTHER|||||||0.9361||95.0|||||ANOVA|||||||0.9361
73953077|NCT04019561|147439617|SUPERIORITY||Mean Difference (Final Values)|-1.41||||0.439|TWO_SIDED|95.0|-5.02|2.2|||ANCOVA|||||2.20|-5.02|0.439
73873191|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73953078|NCT04019561|147439617|SUPERIORITY||Mean Difference (Final Values)|-5.01||||0.006|TWO_SIDED|95.0|-8.54|-1.48|||ANCOVA|||||-1.48|-8.54|0.006
73953079|NCT04019561|147439618|SUPERIORITY||Mean Difference (Final Values)|-1.508||||0.695|TWO_SIDED|95.0|-9.191|6.174|||ANCOVA|||||6.174|-9.191|0.695
73953080|NCT04019561|147439618|SUPERIORITY||Mean Difference (Final Values)|-9.291||||0.016|TWO_SIDED|95.0|-16.76|-1.822|||ANCOVA|||||-1.822|-16.760|0.016
73953081|NCT04019561|147439619|SUPERIORITY||Mean Difference (Final Values)|-10.74||||0.468|TWO_SIDED|95.0|-40.174|18.695|||ANCOVA|||||18.695|-40.174|0.468
73980423|NCT01377844|147505758|SUPERIORITY||Difference of LS Means|-2.67||||0.0015|TWO_SIDED|95.0|-4.3|-1.04||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline diastolic BP, baseline HbA1c category, site, age category, gender and race||||-1.04|-4.30|0.0015
73953082|NCT04019561|147439619|SUPERIORITY||Mean Difference (Final Values)|-37.395||||0.012|TWO_SIDED|95.0|-66.38|-8.409|||ANCOVA|||||-8.409|-66.380|0.012
73953083|NCT04019561|147439620|SUPERIORITY||Mean Difference (Final Values)|6.26||||0.166|TWO_SIDED|95.0|-2.698|15.218|||ANCOVA|||||15.218|-2.698|0.166
73953084|NCT04019561|147439620|SUPERIORITY||Mean Difference (Final Values)|0.749||||0.856|TWO_SIDED|95.0|-7.537|9.035|||ANCOVA|||||9.035|-7.537|0.856
73953085|NCT04019561|147439621|SUPERIORITY||Mean Difference (Final Values)|-3.283||||0.302|TWO_SIDED|95.0|-9.641|3.076|||ANCOVA|||||3.076|-9.641|0.302
73953086|NCT04019561|147439621|SUPERIORITY||Mean Difference (Final Values)|-2.821||||0.304|TWO_SIDED|95.0|-8.316|2.675|||ANCOVA|||||2.675|-8.316|0.304
73953087|NCT04019561|147439622|SUPERIORITY||Mean Difference (Final Values)|1.038||||0.808|TWO_SIDED|95.0|-7.493|9.569|||ANCOVA|||||9.569|-7.493|0.808
73953088|NCT04019561|147439622|SUPERIORITY||Mean Difference (Final Values)|1.106||||0.786|TWO_SIDED|95.0|-7.043|9.255|||ANCOVA|||||9.255|-7.043|0.786
73953089|NCT04019561|147439623|SUPERIORITY||Mean Difference (Final Values)|3.448||||0.087|TWO_SIDED|95.0|-0.524|7.421|||ANCOVA|||||7.421|-0.524|0.087
73953090|NCT04019561|147439623|SUPERIORITY||Mean Difference (Final Values)|-0.387||||0.834|TWO_SIDED|95.0|-4.085|3.312|||ANCOVA|||||3.312|-4.085|0.834
73953091|NCT04019561|147439624|SUPERIORITY||Mean Difference (Final Values)|-0.386||||0.735|TWO_SIDED|95.0|-2.681|1.908|||ANCOVA|||||1.908|-2.681|0.735
73953092|NCT04019561|147439624|SUPERIORITY||Mean Difference (Final Values)|-1.091||||0.308|TWO_SIDED|95.0|-3.226|1.044|||ANCOVA|||||1.044|-3.226|0.308
73953093|NCT04019561|147439625|SUPERIORITY||Mean Difference (Final Values)|-19.277||||0.195|TWO_SIDED|95.0|-48.704|10.15|||ANCOVA|||||10.150|-48.704|0.195
73953094|NCT04019561|147439625|SUPERIORITY||Mean Difference (Final Values)|-24.328||||0.103|TWO_SIDED|95.0|-53.674|5.019|||ANCOVA|||||5.019|-53.674|0.103
73953095|NCT04019561|147439626|SUPERIORITY||Mean Difference (Final Values)|-10.39||||0.6|TWO_SIDED|95.0|-49.802|29.022|||ANCOVA|||||29.022|-49.802|0.600
73953096|NCT04019561|147439626|SUPERIORITY||Mean Difference (Final Values)|7.086||||0.72|TWO_SIDED|95.0|-32.163|46.336|||ANCOVA|||||46.336|-32.163|0.720
73953097|NCT04019561|147439627|SUPERIORITY||Mean Difference (Final Values)|-9.14||||0.485|TWO_SIDED|95.0|-35.134|16.854|||ANCOVA|||||16.854|-35.134|0.485
73953098|NCT04019561|147439627|SUPERIORITY||Mean Difference (Final Values)|-19.645||||0.131|TWO_SIDED|95.0|-45.288|5.999|||ANCOVA|||||5.999|-45.288|0.131
73953099|NCT04019561|147439628|SUPERIORITY||Mean Difference (Final Values)|-0.719||||0.564|TWO_SIDED|95.0|-3.191|1.754|||ANCOVA|||||1.754|-3.191|0.564
73953100|NCT04019561|147439628|SUPERIORITY||Mean Difference (Final Values)|-2.366||||0.062|TWO_SIDED|95.0|-4.854|0.122|||ANCOVA|||||0.122|-4.854|0.062
73953101|NCT04019561|147439629|SUPERIORITY||Mean Difference (Final Values)|-0.084||||0.856|TWO_SIDED|95.0|-1.007|0.838|||ANCOVA|||||0.838|-1.007|0.856
73953102|NCT04019561|147439629|SUPERIORITY||Mean Difference (Final Values)|-0.777||||0.098|TWO_SIDED|95.0|-1.7|0.147|||ANCOVA|||||0.147|-1.700|0.098
73980424|NCT01377844|147505759|SUPERIORITY||Difference of LS Means|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.52|-0.93||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline weight, baseline HbA1c category, site, age category, gender and race||||-0.93|-2.52|< 0.0001
73980425|NCT01377844|147505760|SUPERIORITY||Difference of LS Means|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.42|-0.21||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 2||-0.21|-0.42|< 0.0001
73980426|NCT01377844|147505760|SUPERIORITY||Difference of LS Means|-0.59|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.41||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 6||-0.41|-0.78|< 0.0001
74033085|NCT01953328|147619110|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-72.0|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-79.5|-64.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-64.6|-79.5|<0.001
73980427|NCT01377844|147505760|SUPERIORITY||Difference of LS Means|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.96|-0.48||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 12||-0.48|-0.96|< 0.0001
73980428|NCT01377844|147505760|SUPERIORITY||Difference of LS Means|-0.71|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.44||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 18||-0.44|-0.97|< 0.0001
73980429|NCT01377844|147505760|SUPERIORITY||Difference of LS Means|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.53||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 24||-0.53|-1.06|< 0.0001
73980430|NCT01377844|147505760|SUPERIORITY||Difference of LS Means|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.66||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 36||-0.66|-1.21|< 0.0001
73980431|NCT01377844|147505760|SUPERIORITY||Difference of LS Means|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.7||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 48||-0.70|-1.28|< 0.0001
73980432|NCT01377844|147505760|SUPERIORITY||Difference of LS Means|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.68||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 60||-0.68|-1.27|< 0.0001
73980433|NCT01377844|147505760|SUPERIORITY||Difference of LS Means|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.64||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 72||-0.64|-1.22|< 0.0001
73980434|NCT01377844|147505760|SUPERIORITY||Difference of LS Means|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.69||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 84||-0.69|-1.27|< 0.0001
74033086|NCT01953328|147619111|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-90.8|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-100.9|-80.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-80.7|-100.9|<0.001
73980435|NCT01377844|147505760|SUPERIORITY||Difference of LS Means|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.73||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 96||-0.73|-1.31|< 0.0001
73980436|NCT01377844|147505761|SUPERIORITY||Difference of LS Means|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.79|-1.7||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 2, between EGT0001442 and Placebo group.||-1.70|-2.79|< 0.0001
73980437|NCT01377844|147505761|SUPERIORITY||Difference of LS Means|-2.45|||<|0.0001|TWO_SIDED|95.0|-3.09|-1.81||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 6, between EGT0001442 and Placebo group.||-1.81|-3.09|< 0.0001
74033087|NCT01953328|147619111|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-83.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-92.5|-74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-74.8|-92.5|<0.001
73953103|NCT02320721|147439641|NON_INFERIORITY|Non-inferiority of HOE901-U300 vs Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<0.3%.|LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.056|||TWO_SIDED|95.0|-0.092|0.129||||||Analysis was performed using ANCOVA model including the fixed categorical effects of treatment group, randomization strata, as well as the continuous fixed covariates of baseline value and following multiple imputation procedure for missing data.||0.129|-0.092|
73953104|NCT02320721|147439642|SUPERIORITY_OR_OTHER_LEGACY|A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only if previous endpoint was statistically significant at 0.05 level.|Relative risk|1.01||||0.8415|TWO_SIDED|95.0|0.89|1.153||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was done by Cochran-Mantel-Haenszel method with randomization strata (screening HbA1c \[\<8.0%; ≥8.0%\], previous use of insulin \[naive, pre-treated\], use of sulfonylurea or meglitinides at screening \[yes, no\]), following multiple imputation procedure for missing data.||1.153|0.890|0.8415
73980438|NCT01377844|147505761|SUPERIORITY||Difference of LS Means|-2.42|||<|0.0001|TWO_SIDED|95.0|-3.06|-1.77||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 12, between EGT0001442 and Placebo group.||-1.77|-3.06|< 0.0001
73980439|NCT01377844|147505761|SUPERIORITY||Difference of LS Means|-2.71|||<|0.0001|TWO_SIDED|95.0|-3.3|-2.11||The p-value is from a two-sided t-test for the difference in means of change from baseline.|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 18, between EGT0001442 and Placebo group.||-2.11|-3.30|< 0.0001
73980440|NCT01377844|147505761|SUPERIORITY||Difference of LS Means|-2.63|||<|0.0001|TWO_SIDED|95.0|-3.24|-2.02||The p-value is from a two-sided t-test for the difference in means of change from baseline.|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 24, between EGT0001442 and Placebo group.||-2.02|-3.24|< 0.0001
73873192|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.75|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.75
73873193|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73980441|NCT01928732|147505763|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|1.0|1.65|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Response Odds Ratio (OR). Response is defined as greater than or equal to 10 point improvement in severity.||1.65|1.00|
73980442|NCT01928732|147505763|SUPERIORITY||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|1.12|1.74|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Loss of Diagnosis Odds Ratio (OR). Loss of Diagnosis is defined as Response, plus no longer meeting DSM-5 symptom criteria and severity less than 25.||1.74|1.12|
73980443|NCT01928732|147505763|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|1.24|2.0|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Remission Odds Ratio (OR). Remission is defined as loss of diagnosis plus severity less than 12.||2.00|1.24|
73980444|NCT01185340|147505771|SUPERIORITY_OR_OTHER|||||||0.751|||||||Mixed Models Analysis|||||||0.751
73980445|NCT02065895|147505790|OTHER|ANOVA was used to first tests the hypothesis that there is a difference among the three groups.|Mean Difference (Final Values)|66.8||||0.0011|TWO_SIDED|95.0|33.4|80.3||The p value was adjusted for multiple comparisons using Sidak's correction. A priori the pimary outcome was defined as blood glucose AUC from 8 am - 12pm; however we used blood glucose AUC from 8am - 2pm to capture the entire meal response.|ANOVA|||Differences among the 3 groups were assessed by repeated measures ANOVA using Sidak's correction for multiple comparisons. All subjects were analyzed as a single group, no comparison group.||80.3|33.4|0.0011
74033088|NCT01953328|147619111|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-69.6|STANDARD_ERROR_OF_MEAN|3.5|<|0.001|TWO_SIDED|95.0|-76.5|-62.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.6|-76.5|<0.001
74033089|NCT01953328|147619111|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.5|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-73.8|-57.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-57.1|-73.8|<0.001
73873194|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73953105|NCT01778062|147439655|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73980446|NCT02065895|147505791|OTHER|||||||0.0059|||||||ANOVA|||||||0.0059
74033090|NCT01953328|147619112|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.67|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-73.06|-64.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-64.27|-73.06|<0.001
74033091|NCT01953328|147619112|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.95|STANDARD_ERROR_OF_MEAN|1.91|<|0.001|TWO_SIDED|95.0|-69.74|-62.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.16|-69.74|<0.001
74033092|NCT01953328|147619112|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.14|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-73.3|-62.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.99|-73.30|<0.001
74033093|NCT01953328|147619112|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-67.28|STANDARD_ERROR_OF_MEAN|1.94|<|0.001|TWO_SIDED|95.0|-71.14|-63.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.42|-71.14|<0.001
74033094|NCT01953328|147619113|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.93|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-73.96|-63.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.89|-73.96|<0.001
74033095|NCT01953328|147619113|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.58|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-67.96|-59.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.21|-67.96|<0.001
74033096|NCT01953328|147619113|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.82|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-74.79|-62.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.86|-74.79|<0.001
74033097|NCT01953328|147619113|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.89|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-65.78|-55.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.99|-65.78|<0.001
74033098|NCT01953328|147619114|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.44|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-68.49|-60.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-60.39|-68.49|<0.001
74033099|NCT01953328|147619114|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-59.24|STANDARD_ERROR_OF_MEAN|2.05|<|0.001|TWO_SIDED|95.0|-63.3|-55.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.17|-63.30|<0.001
74033100|NCT01953328|147619114|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.06|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-64.87|-55.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.25|-64.87|<0.001
74033101|NCT01953328|147619114|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.39|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-67.15|-59.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.62|-67.15|<0.001
74033102|NCT01953328|147619115|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.56|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-70.34|-60.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-60.79|-70.34|<0.001
74033103|NCT01953328|147619115|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.23|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-62.05|-52.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-52.40|-62.05|<0.001
74033104|NCT01953328|147619115|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.37|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-65.91|-54.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-54.83|-65.91|<0.001
74033105|NCT01953328|147619115|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-56.15|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-60.92|-51.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-51.39|-60.92|<0.001
73873195|NCT01128426|147289440|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873196|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
73873197|NCT01128426|147289440|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73980447|NCT02005172|147505804|EQUIVALENCE|The primary analysis used the TOST procedure for equivalence. A difference of less than 10% between devices on the proportion of diagnostic days during the monitoring period was considered to be equivalent. We hypothesized that the percentage of diagnostic days for the ELR and the KM would be 20% and 15%, respectively.||||||||||||||||For the primary endpoint, equivalence testing using the two one-sided test procedure was used to compare the proportion of (unpaired) days in which a diagnostic recording was made with each device during the monitoring period. For the purpose of this study, a difference of less than 10% between devices on the rate of detection of arrhythmias was taken to indicate equivalence.|"Descriptive statistics (means, standard deviation (SD), percentages) were used to summarize the demographic and clinical characteristics of the patients. The total number of tracings and the percentage of tracings with arrhythmias for each device were also calculated.~For the primary endpoint, equivalence testing using the two one-sided test (TOST) procedure was used to compare the proportion of (unpaired) days in which a diagnostic recording was made with each device during the monitoring period. Patients were asked to use both devices for the same duration. For the purpose of this study, a difference of less than 10% between devices on the rate of detection of arrhythmias was taken to indicate equivalence. The primary hypothesis was that the KM"|||
73980448|NCT00704340|147505839|SUPERIORITY_OR_OTHER|||||||0.613|||||||t-test, 2 sided|||The sample size was selected to provide sufficient precision for 95% confidence intervals for the incidence of neurosurgical complications in each arm. The sample size was selected so that the half-width of the normal approximation-based intervals would be no more than 0.05 percentage points. This requires a sample size of 114 evaluable patients in each arm. To allow for loss to follow-up, the sample size was increased to 125 randomized patients in each treatment arm, or a total of 250 patients.||||.613
73980449|NCT00704340|147505840|SUPERIORITY_OR_OTHER|||||||0.681|||||||t-test, 2 sided|||||||.681
73980450|NCT00704340|147505841|SUPERIORITY_OR_OTHER|||||||0.619|||||||t-test, 2 sided|||||||.619
73980451|NCT03331978|147505844|SUPERIORITY||Mean Difference (Net)|6.89|STANDARD_ERROR_OF_MEAN|3.91||0.08|TWO_SIDED|95.0|-0.82|14.61|||Regression, Linear|Model is adjusted for participant sex, which was found to be significantly associated with adherence in a similar repeated measures model.|Values entered are for regression coefficient for intervention indicator (versus control) and represents the adjusted difference across all follow-up time points.|Tested with repeated measures linear regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and continuous adherence measured at baseline. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.||14.61|-0.82|.08
74033106|NCT01953328|147619116|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.54|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-49.35|-41.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.73|-49.35|<0.001
74033107|NCT01953328|147619116|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.43|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|-46.78|-40.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-40.08|-46.78|<0.001
74033108|NCT01953328|147619116|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-40.98|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-44.88|-37.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.08|-44.88|<0.001
74033109|NCT01953328|147619116|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.14|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-46.48|-39.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.80|-46.48|<0.001
74033110|NCT01953328|147619117|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.44|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-49.83|-41.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.05|-49.83|<0.001
74033111|NCT01953328|147619117|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-41.34|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-44.84|-37.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.85|-44.84|<0.001
74033112|NCT01953328|147619117|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-40.96|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-45.35|-36.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-36.57|-45.35|<0.001
73953106|NCT04445155|147439698|SUPERIORITY|||||||0.125|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.125
73953107|NCT04445155|147439700|SUPERIORITY|||||||0.011|||||||Paired t-test|||"Null Hypothesis: The means of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The means of the scores are different at baseline and immediately post-intervention."||||0.011
73953108|NCT04445155|147439701|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.002
73953109|NCT04445155|147439701|SUPERIORITY|||||||0.008|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.008
73953110|NCT04445155|147439702|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||<0.001
73980452|NCT03331978|147505845|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0257|TWO_SIDED|95.0|1.09|3.6||Per above, p-value is from repeated measures logistic regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and baseline dichotomous adherence. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.||3.60|1.09|.0257
73953111|NCT04445155|147439702|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.002
73953112|NCT04445155|147439703|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||<0.001
73980453|NCT03331978|147505846|SUPERIORITY||Odds Ratio (OR)|1.82||||0.26|TWO_SIDED|95.0|0.64|5.18||As mentioned above, p-value comes from repeated measures regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where both post-intervention measurements were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for presence of viral suppression data were used. Fixed effects were an intervention indicator and baseline viral suppression. Model included all viral suppression data (a) at baseline and (b) close to either of the two follow-up surveys.||5.18|0.64|.26
74089485|NCT02149121|147731680|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|89.89|||||TWO_SIDED|90.0|81.85|98.72|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||98.72|81.85|
73953113|NCT04445155|147439703|SUPERIORITY|||||||0.125|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.125
73953114|NCT01875861|147439710|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|1.02|1.38||||||Because of data discontinuity, assumptions for time series analysis did not hold. Repeated measures regression models were developed to compare overall weight monitoring rates at baseline across the implementation phases.||1.38|1.02|
73953115|NCT01875861|147439711|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.03|1.39||||||See comments about time series analysis for primary outcome measure. Repeated measures regression analysis of the likelihood of monitoring for each time period was conducted.||1.39|1.03|
73953116|NCT04213846|147439718|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.94||||0.34|TWO_SIDED|95.0|0.81|1.07|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.07|0.81|0.34
73953117|NCT04213846|147439718|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|1.09||||0.37|TWO_SIDED|95.0|0.91|1.3|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.30|0.91|0.37
73953118|NCT04213846|147439718|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.02||||0.8|TWO_SIDED|95.0|0.85|1.23|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.23|0.85|0.80
73873198|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
73873199|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
73873200|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
73873201|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
73873202|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
73873203|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
73953119|NCT04213846|147439719|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|1.02||||0.75|TWO_SIDED|95.0|0.88|1.2|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.20|0.88|0.75
73873204|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873205|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
73873206|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
73873207|NCT01128426|147289440|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73953120|NCT04213846|147439719|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|1.04||||0.72|TWO_SIDED|95.0|0.86|1.25|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.25|0.86|0.72
74033113|NCT01953328|147619117|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-38.44|STANDARD_ERROR_OF_MEAN|1.93|<|0.001|TWO_SIDED|95.0|-42.26|-34.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.62|-42.26|<0.001
73873208|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
73873209|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
73873210|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873211|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873212|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
73873213|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
73873214|NCT01128426|147289440|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
73873215|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
73873216|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873217|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73873218|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
73873219|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.20
73873220|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73873221|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
73953121|NCT04213846|147439719|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.01||||0.91|TWO_SIDED|95.0|0.85|1.21|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.21|0.85|0.91
73980454|NCT03331978|147505847|SUPERIORITY||Odds Ratio (OR)|0.57||||0.05|TWO_SIDED|95.0|0.32|1.0||As mentioned above, p-value is from repeated measures regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.||1.00|0.32|.05
73953122|NCT04213846|147439720|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.83||||0.04|TWO_SIDED|95.0|0.69|0.99|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||0.99|0.69|0.04
73953123|NCT04213846|147439720|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|0.98||||0.84|TWO_SIDED|95.0|0.77|1.23|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.23|0.77|0.84
73953124|NCT04213846|147439720|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|0.9||||0.34|TWO_SIDED|95.0|0.73|1.22|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.22|0.73|0.34
73953125|NCT04213846|147439721|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.98||||0.78|TWO_SIDED|95.0|0.82|1.16|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.16|0.82|0.78
73953126|NCT04213846|147439721|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|0.9||||0.27|TWO_SIDED|95.0|0.75|1.08|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.08|0.75|0.27
73953127|NCT04213846|147439721|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.01||||0.95|TWO_SIDED|95.0|0.84|1.2|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.20|0.84|0.95
73873222|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
73873223|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73953128|NCT04213846|147439722|SUPERIORITY|Generalized linear model was estimated using a sample of N=346.|Count/Rate Ratio|0.98||||0.69|TWO_SIDED|95.0|0.89|1.08|||Generalized linear mixed model|Model controlled for sex, age, and college type (2-year vs. 4-year) and used a negative binomial error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.08|0.89|0.69
73953129|NCT00802841|147439747|SUPERIORITY_OR_OTHER|||||||0.3106|TWO_SIDED||||||Fisher Exact|||||||0.3106
73953130|NCT00377741|147439764|SUPERIORITY_OR_OTHER||Mean exposure ratio for AUC(0-tau)|1.24|||||TWO_SIDED|90.0|0.98|1.55||||||||1.55|0.98|
73953131|NCT00377741|147439765|SUPERIORITY_OR_OTHER||Mean exposure ratio for Cmax|1.12|||||TWO_SIDED|90.0|0.88|1.42||||||||1.42|0.88|
73953132|NCT01115998|147439778|SUPERIORITY_OR_OTHER|||||||0.02||||||The a priori alpha level was \< 0.10 and was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.02
73980455|NCT03331978|147505848|SUPERIORITY||Mean Difference (Net)|-0.215|STANDARD_ERROR_OF_MEAN|0.091||0.0199|TWO_SIDED|95.0|-0.395|-0.034||As described above, p-value is from repeated measures regression with standard errors adjusted for clustering on participant|Regression, Linear||Estimation parameter is the regression coefficient for intervention indicator (vs. control) and represents the adjusted difference across both follow-up time points.|Tested with repeated measures linear regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.||-0.034|-0.395|.0199
73980456|NCT02935673|147505862|SUPERIORITY||AUC(1-7) difference vs (pooled) placebo|-0.32|||||TWO_SIDED|95.0|-0.89|0.24|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.|0.24|-0.89|
73980457|NCT02935673|147505862|SUPERIORITY||AUC(1-7) difference vs (pooled) placebo|-0.36|||||TWO_SIDED|95.0|-1.33|0.62|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.|0.62|-1.33|
73980458|NCT00813709|147505897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.555||||0.002|TWO_SIDED|95.0|0.378|0.816|||Log Rank|||||0.816|0.378|0.002
73980459|NCT00813709|147505897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.006|TWO_SIDED|95.0|0.391|0.839|||Log Rank|||||0.839|0.391|0.006
73980460|NCT00813709|147505897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.993||||0.941|TWO_SIDED|95.0|0.654|1.51|||Log Rank|||||1.510|0.654|0.941
73980461|NCT00813709|147505898|SUPERIORITY_OR_OTHER|||||||0.205||95.0|||||Log Rank|||||||0.205
73980462|NCT00813709|147505898|SUPERIORITY_OR_OTHER|||||||0.263||95.0|||||Log Rank|||||||0.263
73873224|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73953133|NCT01115998|147439778|SUPERIORITY_OR_OTHER|||||||0.52||||||The a priori alpha level was \<0.10 and was not adjusted for multiple comparisons|Wilcoxon Signed-Rank Test|||"Self-care functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.52
73980463|NCT00813709|147505898|SUPERIORITY_OR_OTHER|||||||0.629||95.0|||||Log Rank|||||||0.629
73980464|NCT01393964|147505947|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|104.096||||0.704|TWO_SIDED|90.0|86.983|124.576|||ANOVA|||The reference arm is NRF participants.||124.576|86.983|0.704
74033114|NCT01953328|147619118|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.77|STANDARD_ERROR_OF_MEAN|2.32|<|0.001|TWO_SIDED|95.0|-59.37|-50.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-50.17|-59.37|<0.001
73953134|NCT01115998|147439778|SUPERIORITY_OR_OTHER|||||||0.38||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.38
73953135|NCT01115998|147439778|SUPERIORITY_OR_OTHER|||||||0.03||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility care giver assistance.~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.03
73980465|NCT01393964|147505947|SUPERIORITY_OR_OTHER||ratio of adjusted means|100.454||||0.965|TWO_SIDED|90.0|84.453|119.488|||ANOVA|||The reference arm is NRF participants.||119.488|84.453|0.965
73980466|NCT01393964|147505948|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|126.596||||0.164|TWO_SIDED|90.0|95.52|167.783|||ANOVA|||AUC(0-T). The reference arm is NRF participants.||167.783|95.52|0.164
73980467|NCT01393964|147505948|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|116.123||||0.355|TWO_SIDED|90.0|88.458|152.439|||ANOVA|||AUC(0-T). The reference arm is NRF participants.||152.439|88.458|0.355
73980468|NCT01393964|147505948|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|129.858||||0.228|TWO_SIDED|90.0|90.366|186.609|||ANOVA|||AUC (INF). The reference arm is NRF participants.||186.609|90.366|0.228
73980469|NCT01393964|147505948|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|110.4||||0.642|TWO_SIDED|90.0|76.825|158.647|||ANOVA|||AUC(INF). The reference arm is NRF participants.||158.647|76.825|0.642
73980470|NCT04405180|147505958|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|4.0||0.9017|TWO_SIDED|||||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data|ANCOVA|||||||0.9017
74033115|NCT01953328|147619118|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.66|STANDARD_ERROR_OF_MEAN|2.17|<|0.001|TWO_SIDED|95.0|-56.95|-48.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-48.36|-56.95|<0.001
74089486|NCT02149121|147731680|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|106.58|||||TWO_SIDED|90.0|97.03|117.08|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||117.08|97.03|
73873225|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
73873226|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73873227|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
73980471|NCT04405180|147505959|SUPERIORITY||Mean Difference (Net)|0.0342|STANDARD_ERROR_OF_MEAN|0.0417||0.4215|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.4215
73980472|NCT04405180|147505960|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|53.0||0.9024|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||.9024
73980473|NCT04405180|147505961|SUPERIORITY||Mean Difference (Net)|-59.0|STANDARD_ERROR_OF_MEAN|42.0||0.1646|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.1646
73980474|NCT04405180|147505962|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.2||0.9814|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.9814
73980475|NCT04405180|147505963|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6217|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.6217
73980476|NCT04405180|147505964|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.7981|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.7981
73980477|NCT04405180|147505965|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6677|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.6677
73980478|NCT04405180|147505966|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.1||0.3745|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.3745
73980479|NCT04405180|147505967|SUPERIORITY||Mean Difference (Net)|243.0|STANDARD_ERROR_OF_MEAN|400.0||0.5496|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.5496
73980480|NCT00687297|147505969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||1||95.0|||||Fisher Exact|||Fisher's exact test with two-sided Type I error of 5% was used to test the null hypothesis of no difference in response rate between arms.||||1.00
73980481|NCT00687297|147505970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.02|TWO_SIDED|95.0|1.07|2.07||p-value from Wald test|Regression, Cox|The model was adjusted for gender (male vs. female) and stage (Stage IIIB vs. Stage IV/Recurrent)||There was 80% power to detect a 50% improvement in median progression-free survival, using a stratified log-rank test with one-sided Type I error of 10%.||2.07|1.07|0.02
73980482|NCT01228734|147505971|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.629|||<|0.001|TWO_SIDED|95.0|0.498|0.794|||Log Rank|||||0.794|0.498|<0.001
73873228|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
73873229|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873230|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
73873231|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73980483|NCT01584648|147505994|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.59|0.91|||||Hazard ratios (HRs) were estimated using a Pike estimator.|||0.91|0.59|
73980484|NCT01584648|147505995|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.64|1.02|||||Hazard ratios (HRs) were estimated using a Pike estimator.|||1.02|0.64|
73980485|NCT01137682|147506002|SUPERIORITY||Odds Ratio (OR)|16.63||||0.0006|TWO_SIDED|95.0|3.32||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||||3.32|0.0006
73980486|NCT01137682|147506002|SUPERIORITY||Odds Ratio (OR)|23.03|||<|0.0001|TWO_SIDED|95.0|4.72||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||||4.72|<0.0001
73980487|NCT04421456|147506022|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.|Least square mean difference|-1.75|STANDARD_ERROR_OF_MEAN|2.33||0.4528|TWO_SIDED|95.0|-6.35|2.84|||Mixed-effects repeated measures model|||||2.84|-6.35|0.4528
74089487|NCT02149121|147731681|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|94.92|||||TWO_SIDED|90.0|89.61|100.55|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||100.55|89.61|
74089488|NCT02149121|147731681|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|89.0|||||TWO_SIDED|90.0|84.01|94.28|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||94.28|84.01|
74089489|NCT02149121|147731681|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|106.66|||||TWO_SIDED|90.0|100.56|113.13|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||113.13|100.56|
73873232|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873233|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73980488|NCT04421456|147506022|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.|Least square mean difference|-1.96|STANDARD_ERROR_OF_MEAN|2.44||0.4226|TWO_SIDED|95.0|-6.76|2.85|||Mixed-effects repeated measures model|||||2.85|-6.76|0.4226
73980489|NCT04421456|147506023|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.83||0.4479|TWO_SIDED|95.0|-2.25|1.0|||Mixed-effects repeated measures model|||||1.00|-2.25|0.4479
73980490|NCT04421456|147506023|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.87||0.1616|TWO_SIDED|95.0|-2.92|0.49|||Mixed-effects repeated measures model|||||0.49|-2.92|0.1616
73980491|NCT04421456|147506024|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.76||0.6787|TWO_SIDED|95.0|-1.8|1.18|||Mixed-effects repeated measures model|||||1.18|-1.80|0.6787
73980492|NCT04421456|147506024|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.78||0.3351|TWO_SIDED|95.0|-0.79|2.3|||Mixed-effects repeated measures model|||||2.30|-0.79|0.3351
73980493|NCT04421456|147506025|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.45||0.4504|TWO_SIDED|95.0|-3.96|1.76|||Mixed-effects repeated measures model|||||1.76|-3.96|0.4504
73980494|NCT04421456|147506025|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.23|STANDARD_ERROR_OF_MEAN|1.52||0.4195|TWO_SIDED|95.0|-4.22|1.76|||Mixed-effects repeated measures model|||||1.76|-4.22|0.4195
73873234|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73953136|NCT01115998|147439778|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon Signed-Rank Test|The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.||"Self-care caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||.006
73953137|NCT01115998|147439778|SUPERIORITY_OR_OTHER|||||||0.45||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.45
73953138|NCT01115998|147439779|SUPERIORITY_OR_OTHER|||||||0.92||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Adaptive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.92
73953139|NCT01115998|147439779|SUPERIORITY_OR_OTHER|||||||0.38||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Cognitive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.38
73953140|NCT01115998|147439779|SUPERIORITY_OR_OTHER|||||||0.42||90.0||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Communication total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.42
73953141|NCT01115998|147439779|SUPERIORITY_OR_OTHER|||||||0.57||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Motor total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.57
73980495|NCT04421456|147506026|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.885|TWO_SIDED|95.0|-0.35|0.3|||Mixed-effects repeated measures model|||||0.30|-0.35|0.8850
73873235|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
73953142|NCT01115998|147439779|SUPERIORITY_OR_OTHER|||||||0.69||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Personal-social total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.69
73953143|NCT01115998|147439779|SUPERIORITY_OR_OTHER|||||||0.28||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"BID total score~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.28
73953144|NCT01115998|147439780|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Reactive scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||>0.10
73953145|NCT01115998|147439780|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Self Initiated Scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||>0.10
73980496|NCT04421456|147506026|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.7808|TWO_SIDED|95.0|-0.36|0.27|||Mixed-effects repeated measures model|||||0.27|-0.36|0.7808
73980497|NCT04421456|147506027|SUPERIORITY||Odds Ratio (OR)|1.412||||0.6707|TWO_SIDED|95.0|0.288|6.924|||Regression, Logistic|||||6.924|0.288|0.6707
73980498|NCT04421456|147506027|SUPERIORITY||Odds Ratio (OR)|0.576||||0.4883|TWO_SIDED|95.0|0.121|2.744|||Regression, Logistic|||||2.744|0.121|0.4883
73980499|NCT00244751|147506047|SUPERIORITY_OR_OTHER|||||||0.3608|||||||reduced regression model|||||||0.3608
73980500|NCT00244751|147506047|SUPERIORITY_OR_OTHER|||||||0.3575|||||||reduced regression model|||||||0.3575
73980501|NCT00244751|147506048|SUPERIORITY_OR_OTHER|||||||0.9157|||||||reduced regression model|||||||0.9157
73980502|NCT00244751|147506048|SUPERIORITY_OR_OTHER|||||||0.9501|||||||reduced regression model|||||||0.9501
73980503|NCT00244751|147506049|SUPERIORITY_OR_OTHER|||||||0.6483|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (fibrosis)||||0.6483
73980504|NCT00244751|147506049|SUPERIORITY_OR_OTHER|||||||0.1776|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (necrosis)||||0.1776
73980505|NCT01694199|147506075|SUPERIORITY_OR_OTHER|||||||0.3529|||||||ANCOVA|||||||0.3529
73980506|NCT01694199|147506076|SUPERIORITY_OR_OTHER|||||||0.2766|||||||ANCOVA|||||||0.2766
73980507|NCT01694199|147506077|SUPERIORITY_OR_OTHER|||||||0.1467|||||||ANOVA|||P=0.1467||||0.1467
73980508|NCT01694199|147506078|SUPERIORITY_OR_OTHER|||||||0.5009|||||||ANOVA|||P = 0.5009||||0.5009
73980509|NCT01694199|147506079|SUPERIORITY_OR_OTHER|||||||0.9038|||||||ANOVA|||||||0.9038
73980510|NCT02206607|147506080|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|31.27|||||TWO_SIDED|90.0|28.09|34.8||||||||34.80|28.09|
73980511|NCT02206607|147506080|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|25.56|||||TWO_SIDED|90.0|23.11|28.27||||||||28.27|23.11|
73980512|NCT02206607|147506080|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|32.04|||||TWO_SIDED|90.0|28.93|35.49||||||||35.49|28.93|
73980513|NCT02206607|147506081|SUPERIORITY_OR_OTHER||Least Square Mean|15.72|STANDARD_ERROR_OF_MEAN|3.357||1|TWO_SIDED|80.0|11.39|20.06||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.||||20.06|11.39|1.0000
73980514|NCT02206607|147506081|SUPERIORITY_OR_OTHER||Least Square Mean|16.31|STANDARD_ERROR_OF_MEAN|3.399||1|TWO_SIDED|80.0|11.93|20.7||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.||||20.70|11.93|1.000
73980515|NCT02206607|147506081|SUPERIORITY_OR_OTHER||Least Square Mean|20.38|STANDARD_ERROR_OF_MEAN|3.291||1|TWO_SIDED|80.0|16.13|24.62||1-sided p-value|Mixed Models Analysis|||||24.62|16.13|1.0000
73980516|NCT02206607|147506082|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|25.21|||||TWO_SIDED|90.0|23.28|27.31||||||||27.31|23.28|
73980517|NCT02206607|147506082|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|26.38|||||TWO_SIDED|90.0|24.36|28.57||||||||28.57|24.36|
73980518|NCT02206607|147506082|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|36.94|||||TWO_SIDED|90.0|34.09|40.02||||||||40.02|34.09|
73980519|NCT02206607|147506088|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|31.06|||||TWO_SIDED|90.0|28.28|34.1||||||||34.10|28.28|
73980520|NCT02206607|147506088|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|24.96|||||TWO_SIDED|90.0|22.73|27.4||||||||27.40|22.73|
73980521|NCT02206607|147506088|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|31.69|||||TWO_SIDED|90.0|28.86|34.81||||||||34.81|28.86|
73980522|NCT01262456|147506091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.0001|TWO_SIDED|95.0|-0.61|-0.22||A priori threshold for significance was p\<=0.05.|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.22|-0.61|<0.0001
73980523|NCT01262456|147506091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0003|TWO_SIDED|95.0|-0.57|-0.17||A priori threshold for significance was p\<=0.05|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.17|-0.57|0.0003
73980524|NCT01262456|147506092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.0004|TWO_SIDED|95.0|1.38|3.03||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.||3.03|1.38|0.0004
73980525|NCT01262456|147506092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.0009|TWO_SIDED|95.0|1.32|2.96||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.||2.96|1.32|0.0009
73980526|NCT01262456|147506093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0029|TWO_SIDED|95.0|-0.57|-0.12||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."||-0.12|-0.57|0.0029
73873236|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
73873237|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873238|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
73980527|NCT01262456|147506093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0128|TWO_SIDED|95.0|-0.52|-0.06||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."||-0.06|-0.52|0.0128
73980528|NCT01262456|147506094|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0233|TWO_SIDED|95.0|1.08|3.02||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||3.02|1.08|0.0233
73980529|NCT01262456|147506094|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0386|TWO_SIDED|95.0|1.03|2.87||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||2.87|1.03|0.0386
73980530|NCT01262456|147506095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.76||||0.0026|TWO_SIDED|95.0|15.02|70.51||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||70.51|15.02|0.0026
73980531|NCT01262456|147506095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.95||||0.0064|TWO_SIDED|95.0|11.03|66.88||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||66.88|11.03|0.0064
73980532|NCT01262456|147506096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-86.17||||0.0034|TWO_SIDED|95.0|-143.69|-28.64||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||-28.64|-143.69|0.0034
73980533|NCT01262456|147506096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-77.8||||0.0086|TWO_SIDED|95.0|-135.7|-19.89||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||-19.89|-135.70|0.0086
73980534|NCT01262456|147506097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.31||||0.4126|TWO_SIDED|95.0|-153.94|63.32||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||63.32|-153.94|0.4126
73980535|NCT01262456|147506097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.79||||0.7353|TWO_SIDED|95.0|-127.99|90.41||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||90.41|-127.99|0.7353
74033116|NCT01953328|147619118|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.83|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-54.72|-46.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.93|-54.72|<0.001
73873239|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873240|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73873241|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
73980536|NCT04012970|147506112|SUPERIORITY||||||<|0.05|||||||ANOVA|2-way, repeated measures||||||<0.05
73980537|NCT04012970|147506112|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.01
73980538|NCT04012970|147506113|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
73980539|NCT04012970|147506113|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.01
73980540|NCT04012970|147506114|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
73873242|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73980541|NCT04012970|147506114|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.05
73980542|NCT04012970|147506115|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
73873243|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
73873244|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73953146|NCT02819479|147439781|OTHER||eta^2|0.37||||0.012|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(1,14) = 8.29||CHANGE IN VOLUME OF RADIATION NECROSIS: To explore durability of radiographic responses, we invoked a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.012
73953147|NCT02819479|147439781|OTHER||eta^2|0.19||||0.09|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(1,14) = 3.29||CHANGE IN VOLUME OF CEREBRAL EDEMA: To explore durability of radiographic responses, we invoked a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.09
73980543|NCT04012970|147506115|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.05
73980544|NCT04012970|147506116|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
73980545|NCT04012970|147506117|SUPERIORITY||||||<|0.001|||||||ANOVA|2-way, repeated measures||||||<0.001
73980546|NCT04867382|147506118|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.27||0.63|TWO_SIDED||||||t-test, 2 sided|||||||.63
73980547|NCT04867382|147506119|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.27
73980548|NCT04867382|147506120|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.37|TWO_SIDED||||||t-test, 2 sided|||||||.37
74089490|NCT02149121|147731682|EQUIVALENCE|Therapeutic equivalence was to be concluded if the 90% CI for the treatment difference in the change from baseline of DAS28 (CRP) at Week 24 was entirely within the equivalence margin of ±0.50.|Mean Difference (Final Values)|-0.01|||||TWO_SIDED|90.0|-0.22|0.2|||||Adjusted least squares means and standard error, estimate of treatment difference \[CT-P10 - (Rituxan + MabThera)\] and 2-sided 90% confidence interval calculated from the ANCOVA model.|Primary efficacy analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, study part, interaction of treatment group with study part, prior anti TNF alpha blocker status at baseline (intolerance case versus inadequate response), and RF or anti-CCP status fitted as covariates.||0.20|-0.22|
73980549|NCT04867382|147506121|SUPERIORITY||Odds Ratio (OR)|1.75||||0.12|TWO_SIDED|95.0|0.86|3.57|||Regression, Logistic|||||3.57|0.86|.12
73873245|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873246|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73980550|NCT01326455|147506122|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED|95.0|||||Chi-squared|||Lancaster et. al. (2004) quoted the number 30 as a general sample size for a pilot study. Each arm of this study had 25 people (due to time constraints), giving a total of 75 people. The data were analyzed using t-tests for equality of means, a two-way analysis of variance (ANOVA), and chi-square. Significance was set at p \< 0.05.||||0.25
73980551|NCT01326455|147506123|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Chi-squared|||||||0.47
73980552|NCT01326455|147506124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||ANOVA|||||||0.002
73980553|NCT01326455|147506124|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
73980554|NCT01326455|147506124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.144|||||||ANOVA|||||||0.144
73980555|NCT01326455|147506125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372|||||||ANOVA|||||||0.372
73980556|NCT01326455|147506126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.468|||||||Chi-squared|||||||0.468
73980557|NCT01079949|147506143|SUPERIORITY_OR_OTHER|||||||0.5739||95.0|||||Wilcoxon two sample test|||||||0.5739
73980558|NCT01079949|147506148|SUPERIORITY_OR_OTHER|||||||0.1734||95.0|||||Wilcoxon two sample test|||||||0.1734
73980559|NCT01079949|147506149|SUPERIORITY_OR_OTHER|||||||0.0642||95.0|||||Wilcoxon two sample test|||||||0.0642
73980560|NCT01079949|147506153|SUPERIORITY_OR_OTHER|||||||0.408||95.0|||||Wilcoxon two sample test|||||||0.4080
73980561|NCT01079949|147506156|SUPERIORITY_OR_OTHER|||||||0.0648||95.0|||||Wilcoxon two sample test|||||||0.0648
73980562|NCT01079949|147506157|SUPERIORITY_OR_OTHER|||||||0.6799||95.0|||||ANOVA|||||||0.6799
73980563|NCT01079949|147506158|SUPERIORITY_OR_OTHER|||||||0.0634||95.0|||||Wilcoxon two sample test|||||||0.0634
74033117|NCT01953328|147619118|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.69|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-53.74|-45.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-45.64|-53.74|<0.001
73873247|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873248|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
73980564|NCT01079949|147506160|SUPERIORITY_OR_OTHER|||||||0.0166||95.0|||||Wilcoxon two sample test|||||||0.0166
73980565|NCT01079949|147506161|SUPERIORITY_OR_OTHER|||||||0.8812||95.0|||||ANOVA|||||||0.8812
73980566|NCT03854734|147506190|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|1.0|1.25|||Regression, Logistic|||Analysis for vaccine intention of Tdap||1.25|1.00|
73980567|NCT03854734|147506190|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|1.0|1.29|||Regression, Logistic|||Analysis for vaccine intention of MCV||1.29|1.00|
73980568|NCT03854734|147506190|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.96|1.14|||Regression, Logistic|||Analysis for vaccine intention of HPV||1.14|0.96|
73980569|NCT01250717|147506200|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.12||||||||0.12|0|
73980570|NCT00246129|147506201|SUPERIORITY|||||||0.467|||||||Log Rank|||||||0.467
73980571|NCT00246129|147506202|SUPERIORITY|||||||0.138|||||||Log Rank|||||||0.138
74033118|NCT01953328|147619119|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-55.45|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-60.93|-49.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-49.98|-60.93|<0.001
73980572|NCT01286311|147506210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.54|1.86|||Generalized Logistic Regression|||||1.86|0.54|0.99
73980573|NCT01286311|147506211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.27|TWO_SIDED|95.0|0.84|1.85|||Generalized Logistic Regression|||||1.85|0.84|0.27
73980574|NCT01286311|147506212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.038|TWO_SIDED|95.0|1.05|4.32|||Generalized Logistic Regression|||||4.32|1.05|0.038
73980575|NCT01286311|147506213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.72||||0.13|TWO_SIDED|95.0|0.73|10.1|||Generalized Logistic Regression|||||10.1|0.73|0.13
73980576|NCT01286311|147506214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18||||0.3|TWO_SIDED|95.0|0.5|9.5|||Generalized Logistic Regression|||||9.5|0.50|0.30
73980577|NCT00805792|147506229|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
73980578|NCT00805792|147506230|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
73980579|NCT00805792|147506231|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
74033119|NCT01953328|147619119|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.95|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-55.91|-46.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.00|-55.91|<0.001
74033120|NCT01953328|147619119|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-51.36|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-55.93|-46.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.80|-55.93|<0.001
74033121|NCT01953328|147619119|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.44|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-50.08|-40.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-40.81|-50.08|<0.001
74033122|NCT01953328|147619120|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-66.47|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-70.58|-62.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.36|-70.58|<0.001
74089491|NCT02149121|147731687|OTHER||Ratio of geometric least squares means|102.37|||||TWO_SIDED|95.0|92.46|113.33||||||Secondary PD analysis were analyzed using an ANCOVA model with results as the response, treatment group, as fixed effect and baseline values, gender, region, race, study part, interaction of treatment group with study part, prior anti-TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.|Estimate of Geometric Least Square Mean and ratio of Geometric Least Square Means (CT-P10/reference products) were obtained from back transforming the least square means from the ANCOVA.|113.33|92.46|
74033123|NCT01953328|147619120|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.33|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-69.01|-59.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.66|-69.01|<0.001
74033124|NCT01953328|147619120|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.05|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-68.9|-59.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.20|-68.90|<0.001
74033125|NCT01953328|147619120|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-67.26|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-71.36|-63.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.15|-71.36|<0.001
74033126|NCT01953328|147619121|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.29|STANDARD_ERROR_OF_MEAN|2.24|<|0.001|TWO_SIDED|95.0|-72.75|-63.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.84|-72.75|<0.001
74033127|NCT01953328|147619121|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-62.53|STANDARD_ERROR_OF_MEAN|2.81|<|0.001|TWO_SIDED|95.0|-68.11|-56.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-56.94|-68.11|<0.001
74033128|NCT01953328|147619121|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.97|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-69.44|-58.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-58.50|-69.44|<0.001
74033129|NCT01953328|147619121|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.62|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-65.51|-55.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.72|-65.51|<0.001
74033130|NCT01953328|147619122|SUPERIORITY_OR_OTHER||Treatment Difference|98.0|||<|0.001|TWO_SIDED|95.0|86.8|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||99.6|86.8|<0.001
74033131|NCT01953328|147619122|SUPERIORITY_OR_OTHER||Treatment Difference|96.0|||<|0.001|TWO_SIDED|95.0|84.1|98.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||98.9|84.1|<0.001
74033132|NCT01953328|147619122|SUPERIORITY_OR_OTHER||Treatment Difference|73.6|||<|0.001|TWO_SIDED|95.0|57.1|83.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||83.4|57.1|<0.001
74033133|NCT01953328|147619122|SUPERIORITY_OR_OTHER||Treatment Difference|82.4|||<|0.001|TWO_SIDED|95.0|67.5|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||90.0|67.5|<0.001
73873249|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873250|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
73873251|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873252|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
74033134|NCT01953328|147619123|SUPERIORITY_OR_OTHER||Treatment Difference|98.0|||<|0.001|TWO_SIDED|95.0|86.7|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||99.6|86.7|<0.001
74033135|NCT01953328|147619123|SUPERIORITY_OR_OTHER||Treatment Difference|91.8|||<|0.001|TWO_SIDED|95.0|78.2|96.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||96.0|78.2|<0.001
74033136|NCT01953328|147619123|SUPERIORITY_OR_OTHER||Treatment Difference|75.6|||<|0.001|TWO_SIDED|95.0|59.3|85.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||85.0|59.3|<0.001
74089492|NCT03166124|147731688|SUPERIORITY||Ratio of Geometric LSMeans|1.02|||||TWO_SIDED|95.0|0.953|1.1|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.10|0.953|
74089493|NCT03166124|147731688|SUPERIORITY||Ratio of Geometric LSMeans|1.03|||||TWO_SIDED|95.0|0.974|1.09|||Mixed Models Analysis|||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.09|0.974|
74089494|NCT03166124|147731689|SUPERIORITY||Ratio of Geometric LSMeans|1.04|||||TWO_SIDED|95.0|0.96|1.12|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.12|0.96|
73873253|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
73873254|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
73873255|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
73873256|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873257|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
73873258|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
73873259|NCT01128426|147289441|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873260|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
73873261|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
74033137|NCT01953328|147619123|SUPERIORITY_OR_OTHER||Treatment Difference|78.0|||<|0.001|TWO_SIDED|95.0|62.6|86.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||86.9|62.6|<0.001
74033138|NCT01953328|147619124|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-51.2|STANDARD_ERROR_OF_MEAN|6.39|<|0.001|TWO_SIDED|95.0|-63.88|-38.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-38.52|-63.88|<0.001
74033139|NCT01953328|147619124|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.08|STANDARD_ERROR_OF_MEAN|4.94|<|0.001|TWO_SIDED|95.0|-58.89|-39.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.27|-58.89|<0.001
74033140|NCT01953328|147619124|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.55|STANDARD_ERROR_OF_MEAN|5.14|<|0.001|TWO_SIDED|95.0|-59.74|-39.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.35|-59.74|<0.001
74089495|NCT03166124|147731689|SUPERIORITY||Ratio of Geometric LSMeans|1.02|||||TWO_SIDED|95.0|0.94|1.1|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.10|0.94|
74089496|NCT01036490|147731703|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
74089497|NCT01036490|147731704|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
74089498|NCT01036490|147731707|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
74033141|NCT01953328|147619124|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.93|STANDARD_ERROR_OF_MEAN|4.95|<|0.001|TWO_SIDED|95.0|-53.75|-34.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.12|-53.75|<0.001
74033142|NCT01953328|147619125|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.07|STANDARD_ERROR_OF_MEAN|7.64|<|0.001|TWO_SIDED|95.0|-65.25|-34.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.90|-65.25|<0.001
74033143|NCT01953328|147619125|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-48.77|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-60.49|-37.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.05|-60.49|<0.001
74033144|NCT01953328|147619125|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.68|STANDARD_ERROR_OF_MEAN|5.73|<|0.001|TWO_SIDED|95.0|-64.06|-41.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.30|-64.06|<0.001
74033145|NCT01953328|147619125|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-39.97|STANDARD_ERROR_OF_MEAN|5.29|<|0.001|TWO_SIDED|95.0|-50.46|-29.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-29.48|-50.46|<0.001
74033146|NCT01953328|147619126|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.93|STANDARD_ERROR_OF_MEAN|6.72|<|0.001|TWO_SIDED|95.0|-41.27|-14.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-14.59|-41.27|<0.001
74033147|NCT01953328|147619126|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-21.94|STANDARD_ERROR_OF_MEAN|5.34|<|0.001|TWO_SIDED|95.0|-32.54|-11.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-11.35|-32.54|<0.001
74033148|NCT01953328|147619126|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.01|STANDARD_ERROR_OF_MEAN|4.83|<|0.001|TWO_SIDED|95.0|-29.59|-10.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-10.43|-29.59|<0.001
74033149|NCT01953328|147619126|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.72|STANDARD_ERROR_OF_MEAN|6.78||0.01|TWO_SIDED|95.0|-34.18|-7.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-7.26|-34.18|0.010
74033150|NCT01953328|147619127|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.57|STANDARD_ERROR_OF_MEAN|9.45|<|0.001|TWO_SIDED|95.0|-46.33|-8.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.81|-46.33|<0.001
74033151|NCT01953328|147619127|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-19.97|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-31.68|-8.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.25|-31.68|<0.001
74033152|NCT01953328|147619127|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-17.17|STANDARD_ERROR_OF_MEAN|5.53|<|0.001|TWO_SIDED|95.0|-28.15|-6.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-6.19|-28.15|<0.001
74033153|NCT01953328|147619127|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.92|STANDARD_ERROR_OF_MEAN|7.24||0.01|TWO_SIDED|95.0|-31.29|-2.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-2.56|-31.29|0.010
74033154|NCT01953328|147619128|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|12.33|STANDARD_ERROR_OF_MEAN|2.49|<|0.001|TWO_SIDED|95.0|7.39|17.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||17.27|7.39|<0.001
74033155|NCT01953328|147619128|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|14.61|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|9.93|19.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||19.30|9.93|<0.001
74033156|NCT01953328|147619128|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|15.36|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|10.12|20.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||20.60|10.12|<0.001
73953148|NCT02819479|147439782|OTHER||eta^2|0.29||||0.02|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,34) = 2.74||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) TOTAL SCORES were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance)||||0.02
73953149|NCT02819479|147439783|OTHER||eta^2|0.37||||0.019|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,34) = 3.17||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) DAYS OF HEADACHE were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.019
73953150|NCT02819479|147439784|OTHER||eta^2|0.3||||0.0006|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,35) = 3.96||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) MIDAS PAIN LEVEL data were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.0006
73953151|NCT02819479|147439785|OTHER||eta^2|0.3||||0.02|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5, 35) = 2.98||To explore durability of clinical response, Headache Impact Test (HIT-6™) scores were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.02
73953152|NCT02819479|147439786|OTHER||eta^2|0.19||||0.23|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(2,14) = 1.62||To explore durability of clinical response, Karnofsky Performance Status Scale (KPS) data were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.23
73953153|NCT02819479|147439787|OTHER||Pearson's r|-0.199||||0.374|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|Z = -0.889||Wilcoxon signed rank test (2-sided) was used to compare the total number of days on steroids in the 12 months prior versus the 12 months immediately following single dose IA Avastin (bevacizumab).||||0.374
73980580|NCT02753075|147506299|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.09||||0.829|TWO_SIDED|95.0|-0.289|0.461||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.461|-0.289|0.8290
74089499|NCT01036490|147731708|SUPERIORITY_OR_OTHER|||||||0.58|||||||t-test, 2 sided|||||||0.58
73980581|NCT02753075|147506299|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.9993|TWO_SIDED|95.0|-0.372|0.362||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.362|-0.372|0.9993
73980582|NCT02753075|147506300|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.5892|TWO_SIDED|95.0|-0.242|0.424|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.424|-0.242|0.5892
73980583|NCT02753075|147506301|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.2825|TWO_SIDED|95.0|-0.116|0.396|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.396|-0.116|0.2825
73980584|NCT02753075|147506301|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.8448|TWO_SIDED|95.0|-0.229|0.28|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.280|-0.229|0.8448
73980585|NCT02753075|147506301|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.3784|TWO_SIDED|95.0|-0.141|0.371|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.371|-0.141|0.3784
73980586|NCT02753075|147506302|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1688|TWO_SIDED|95.0|-10.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-10.00|0.1688
73980587|NCT02753075|147506302|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.438|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.4380
73980588|NCT02753075|147506302|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5693|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.5693
73980589|NCT02753075|147506303|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7789|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.7789
73953154|NCT02819479|147439788|OTHER||partial eta^2|0.153||||0.66|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.451||DIGITS FORWARD: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DIGITS FORWARD variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.660
74033157|NCT01953328|147619128|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.15|STANDARD_ERROR_OF_MEAN|2.26||0.001|TWO_SIDED|95.0|4.67|13.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||13.62|4.67|0.001
73873262|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
73873263|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73953155|NCT02819479|147439788|OTHER||partial eta^2|0.602||||0.1|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 3.78||DIGITS BACKWARD: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DIGITS BACKWARD variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.100
73953156|NCT02819479|147439788|OTHER||partial eta^2|0.532||||0.149|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 2.847||NUMBERS \& LETTERS SPEED: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS SPEED variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.149
73953157|NCT02819479|147439788|OTHER||partial eta^2|0.721||||0.041|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 6.470||NUMBERS \& LETTERS ERRORS: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS ERRORS variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.041
73953158|NCT02819479|147439788|OTHER||partial eta^2|0.566||||0.124|TWO_SIDED||||||One way Repeat Meas ANOVA|F (2,5) = 3.256||NUMBERS \& LETTERS EFFICIENCY: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS EFFICIENCY variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.124
73953159|NCT02819479|147439788|OTHER||partial eta^2|0.042||||0.898|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.110||NAMING: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NAMING variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.898
73953160|NCT02819479|147439788|OTHER||partial eta^2|0.107||||0.754|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.299||LIST LEARNING LIST IMMEDIATE RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the LIST LEARNING LIST IMMEDIATE RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.754
73953161|NCT02819479|147439788|OTHER||partial eta^2|0.751||||0.031|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 7.556||LIST LEARNING LIST LONG DELAYED RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the LIST LEARNING LIST LONG DELAYED RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.031
73980590|NCT02753075|147506303|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7214|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.7214
73980591|NCT02753075|147506303|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.896|TWO_SIDED|95.0|-5.0|5.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|-5.000|0.8960
73980592|NCT02753075|147506304|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.0978|TWO_SIDED|95.0|-0.084|0.987|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.987|-0.084|0.0978
73873264|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873265|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
73953162|NCT02819479|147439788|OTHER||partial eta^2|0.289||||0.426|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 1.018||SHAPE LEARNING IMMEDIATE RECOGNITION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the SHAPE LEARNING IMMEDIATE RECOGNITION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.426
74033158|NCT01953328|147619129|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|13.46|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|7.4|19.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||19.53|7.40|<0.001
73980593|NCT02753075|147506304|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.4607|TWO_SIDED|95.0|-0.333|0.732|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.732|-0.333|0.4607
73980594|NCT02753075|147506304|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.3542|TWO_SIDED|95.0|-0.283|0.787|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.787|-0.283|0.3542
73980595|NCT02753075|147506305|SUPERIORITY_OR_OTHER||LS mean difference|0.02||||0.9474|TWO_SIDED|95.0|-0.665|0.711|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.711|-0.665|0.9474
73980596|NCT02753075|147506305|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.7987|TWO_SIDED|95.0|-0.76|0.586|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.586|-0.760|0.7987
73980597|NCT02753075|147506305|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.7525|TWO_SIDED|95.0|-0.578|0.798|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.798|-0.578|0.7525
73980598|NCT04471805|147506308|SUPERIORITY||||||<|0.05||||||Post hoc analyses (paired t-tests and Bonferroni correction) and effect size (Cohen's d) were calculated to clarify significant main effects and interactions.|ANOVA|Normality and sphericity evaluated with Shapiro-Wilk test and Mauchly's test. Greenhouse-Geisser corrections used when sphericity was violated.||||||<0.05
73980599|NCT04471805|147506309|SUPERIORITY||||||<|0.05||||||Post hoc analyses (paired t-tests and Bonferroni correction) and effect size (Cohen's d) were calculated to clarify significant main effects and interactions.|ANOVA|Normality and sphericity evaluated with Shapiro-Wilk test and Mauchly's test. Greenhouse-Geisser corrections used when sphericity was violated.||||||<0.05
73980600|NCT01163214|147506311|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
73980601|NCT01163214|147506311|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.58
73980602|NCT01163214|147506312|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||t-test, 2 sided|||||||0.76
73980603|NCT01163214|147506312|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.59
73980604|NCT01163214|147506313|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for intraoperative narcotic use.||||<0.001
73980605|NCT01163214|147506313|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on day of surgery as needed.||||<0.001
73980606|NCT01163214|147506313|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 1 as needed.||||0.17
73980607|NCT01163214|147506313|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 2 as needed.||||0.51
73980608|NCT01163214|147506314|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 morning.||||<0.001
73980609|NCT01163214|147506314|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 afternoon.||||<0.001
73980610|NCT01163214|147506314|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 morning.||||0.002
73980611|NCT01163214|147506314|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 afternoon.||||0.97
73980612|NCT01163214|147506315|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for length of stay in the hospital.||||0.02
73980613|NCT01163214|147506316|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for femoral nerve.||||0.49
73980614|NCT01163214|147506316|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for common peroneal nerve.||||0.01
73980615|NCT01163214|147506316|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for tibial nerve.||||0.62
73980616|NCT01163214|147506316|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for femoral, peroneal, or tibial nerves.||||0.009
73980617|NCT03879538|147506320|SUPERIORITY||Mean Difference (Net)|-0.57||||0.19|TWO_SIDED|95.0|-1.42|0.28||a priori threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Mean difference is Nitrous Oxide minus Control.|Null hypothesis: Mean of pain score assessed at one-week and one-month follow-up after end of treatment for Nitrous Oxide group equals that assessed at same time points for the Control group.||0.28|-1.42|0.19
73980618|NCT03879538|147506321|SUPERIORITY||Mean Difference (Net)|0.13||||0.36|TWO_SIDED|95.0|-0.16|0.43||a priori threshold for statistical significance is p\<0.05.|Mixed Models Analysis||Mean difference is Nitrous oxide minus control.|Null hypothesis for testing difference in means of physical health Z-score between two study groups: mean of physical health Z-score assessed at one-week and one-month follow-ups for Nitrous Oxide group was equal to that assessed at the same follow-up time points for Control group.||0.43|-0.16|0.36
73980619|NCT03879538|147506321|SUPERIORITY||Mean Difference (Net)|0.087||||0.66|TWO_SIDED|95.0|-0.31|0.48||a priori threshold for statistical significance is p\<0.05.|Mixed Models Analysis||Mean difference is Nitrous oxide minus control.|Null hypothesis for testing difference in means of mental health Z-score between two study groups: mean of mental health Z-score assessed at one-week and one-month follow-ups for Nitrous Oxide group was equal to that assessed at the same follow-up time points for Control group.||0.48|-0.31|0.66
73980620|NCT03879538|147506322|SUPERIORITY||Mean Difference (Net)|-0.7||||0.23|TWO_SIDED|95.0|-1.85|0.46||a priori threshold for statistical significance is p = 0.05.|Mixed Models Analysis||Mean difference is Nitrous Oxide minus Control.|Null hypothesis: Mean of PGIC scale assessed at one-week and one-month follow-up time points for Nitrous Oxide patients is equal to that assessed at the same time points for Control patients.||0.46|-1.85|0.23
73953163|NCT02819479|147439788|OTHER||partial eta^2|0.361||||0.326|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 1.412||SHAPE LEARNING DELAYED RECOGNITION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the SHAPE LEARNING DELAYED RECOGNITION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.326
74089500|NCT01172821|147731709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.159|0.264|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.264|0.159|<0.0001
74089501|NCT01172821|147731709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.116|0.222|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.222|0.116|<0.0001
73953164|NCT02819479|147439788|OTHER||partial eta^2|0.09||||0.79|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.247||STORY LEARNING PHRASE UNIT IMMEDIATE RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the STORY LEARNING PHRASE UNIT IMMEDIATE RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.790
73953165|NCT02819479|147439788|OTHER||partial eta^2|0.239||||0.505|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.786||STORY LEARNING PHRASE UNIT DELAYED RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the STORY LEARNING PHRASE UNIT DELAYED RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.505
73953166|NCT02819479|147439788|OTHER||partial eta^2|0.636||||0.08|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 4.362||DESIGN CONSTRUCTION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DESIGN CONSTRUCTION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.080
73953167|NCT02819479|147439788|OTHER||partial eta^2|0.693||||0.052|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 5.654||MAZES: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the MAZES variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.052
73953168|NCT02819479|147439788|OTHER||partial eta^2|0.013||||0.968|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.033||CATEGORIES: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the CATEGORIES variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.968
73953169|NCT02819479|147439788|OTHER||partial eta^2|0.261||||0.469|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.884||WORD GENERATION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the WORD GENERATION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.469
73953170|NCT03531905|147439789|SUPERIORITY||Difference of Least Squares (LS) means|-39.6|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|-45.8|-33.4|||ANCOVA|||||-33.4|-45.8|<0.001
73953171|NCT03531905|147439789|SUPERIORITY||Difference of LS means|-19.5|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-25.7|-13.4|||ANCOVA|||||-13.4|-25.7|<0.001
73953172|NCT03531905|147439789|SUPERIORITY||Difference of LS means|-20.1|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|-26.2|-14.0|||ANCOVA|||||-14.0|-26.2|<0.001
73953173|NCT03531905|147439790|SUPERIORITY||Difference of LS means|-20.1|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|-26.2|-14.0|||ANCOVA|||||-14.0|-26.2|<0.001
73953174|NCT03531905|147439791|SUPERIORITY||Location shift|-36.7|STANDARD_ERROR_OF_MEAN|9.77|<|0.001|TWO_SIDED|95.0|-55.97|-17.67|||Wilcoxon rank sum test|||||-17.67|-55.97|<0.001
74089502|NCT01172821|147731710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.12|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.233|0.120|<0.0001
73953175|NCT03531905|147439791|SUPERIORITY||Location shift|-29.2|STANDARD_ERROR_OF_MEAN|10.03||0.005|TWO_SIDED|95.0|-48.92|-9.62|||Wilcoxon rank sum test|||||-9.62|-48.92|0.005
73953176|NCT03531905|147439791|SUPERIORITY||Location shift|-7.5|STANDARD_ERROR_OF_MEAN|11.29||0.48|TWO_SIDED|95.0|-30.51|13.76|||Wilcoxon rank sum test|||||13.76|-30.51|0.480
73953177|NCT03531905|147439792|SUPERIORITY||Difference of LS means|-33.1|STANDARD_ERROR_OF_MEAN|2.81|<|0.001|TWO_SIDED|95.0|-38.6|-27.5|||ANCOVA|||||-27.5|-38.6|<0.001
73953178|NCT03531905|147439792|SUPERIORITY||Difference of LS means|-15.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-20.8|-9.7|||ANCOVA|||||-9.7|-20.8|<0.001
73953179|NCT03531905|147439792|SUPERIORITY||Difference of LS means|-17.8|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-23.3|-12.4|||ANCOVA|||||-12.4|-23.3|<0.001
73953180|NCT03531905|147439793|SUPERIORITY||Difference of LS means|-27.2|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-31.7|-22.8|||ANCOVA|||||-22.8|-31.7|<0.001
73953181|NCT03531905|147439793|SUPERIORITY||Difference of LS means|-13.4|STANDARD_ERROR_OF_MEAN|2.24|<|0.001|TWO_SIDED|95.0|-17.8|-9.0|||ANCOVA|||||-9.0|-17.8|<0.001
73953182|NCT03531905|147439793|SUPERIORITY||Difference of LS means|-13.9|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-18.2|-9.5|||ANCOVA|||||-9.5|-18.2|<0.001
73953183|NCT03531905|147439794|SUPERIORITY||Difference of LS means|-27.2|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-32.6|-21.8|||ANCOVA|||||-21.8|-32.6|<0.001
73953184|NCT03531905|147439794|SUPERIORITY||Difference of LS means|-12.8|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-18.1|-7.4|||ANCOVA|||||-7.4|-18.1|<0.001
73953185|NCT03531905|147439794|SUPERIORITY||Difference of LS means|-14.4|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-19.7|-9.1|||ANCOVA|||||-9.1|-19.7|<0.001
73953186|NCT03531905|147439795|SUPERIORITY||Location shift|-3.9|STANDARD_ERROR_OF_MEAN|5.44||0.457|TWO_SIDED|95.0|-14.55|6.79|||Wilcoxon rank sum test|||||6.79|-14.55|0.457
73953187|NCT03531905|147439795|SUPERIORITY||Difference of LS means|4.7|STANDARD_ERROR_OF_MEAN|5.25||0.351|TWO_SIDED|95.0|-4.93|15.63|||ANCOVA|||||15.63|-4.93|0.351
73953188|NCT03531905|147439795|SUPERIORITY||Difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|4.75||0.068|TWO_SIDED|95.0|-17.92|0.68|||ANCOVA|||||0.68|-17.92|0.068
73980621|NCT03265132|147506344|SUPERIORITY||Risk Difference (RD)|1.0||||0.0022|TWO_SIDED|95.0|0.42|1.0|||Fisher Exact|||||1.00|0.42|0.0022
73980622|NCT00666705|147506414|SUPERIORITY_OR_OTHER||Ratio (percent)|85.76||||||90.0|79.89|92.07|||Mixed Models Analysis|Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 99% power that the 90% confidence interval (CI) for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the area under the plasma concentration-time profile over the dosing interval (AUCτ) would lie within the acceptance region of (80%, 125%).||92.07|79.89|
73980623|NCT00666705|147506415|SUPERIORITY_OR_OTHER||Ratio (percent)|79.48||||||90.0|67.19|94.02|||Mixed Models Analysis|Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 91% power that the 90% CI for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the maximum concentration (Cmax) would lie within the acceptance region of (80%, 125%).||94.02|67.19|
73980624|NCT00666705|147506416|SUPERIORITY_OR_OTHER||Ratio (percent)|63.25||||||90.0|44.27|90.39|||Mixed Models Analysis|Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.205) on the natural log scale for AUCτ, with 90% coverage probability.||90.39|44.27|
74089503|NCT01172821|147731710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.076|0.19|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.190|0.076|<0.0001
73953189|NCT03531905|147439796|SUPERIORITY||Difference of LS means|-5.9|STANDARD_ERROR_OF_MEAN|2.14||0.007|TWO_SIDED|95.0|-10.1|-1.7|||ANCOVA|||||-1.7|-10.1|0.007
73953190|NCT03531905|147439796|SUPERIORITY||Difference of LS means|-7.3|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-11.5|-3.1|||ANCOVA|||||-3.1|-11.5|<0.001
73953191|NCT03531905|147439796|SUPERIORITY||Difference of LS means|1.4|STANDARD_ERROR_OF_MEAN|2.11||0.517|TWO_SIDED|95.0|-2.8|5.5|||ANCOVA|||||5.5|-2.8|0.517
73953192|NCT03531905|147439797|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73953193|NCT03531905|147439797|SUPERIORITY|||||||0.118|||||||Fisher Exact|||||||0.118
73953194|NCT03531905|147439797|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73953195|NCT03531905|147439798|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73953196|NCT03531905|147439798|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73953197|NCT03531905|147439800|SUPERIORITY||Difference of LS means|-0.3|STANDARD_ERROR_OF_MEAN|1.83||0.877|TWO_SIDED|95.0|-3.9|3.3|||ANCOVA|||||3.3|-3.9|0.877
73953198|NCT03531905|147439800|SUPERIORITY||Difference of LS means|0.8|STANDARD_ERROR_OF_MEAN|1.83||0.669|TWO_SIDED|95.0|-2.8|4.4|||ANCOVA|||||4.4|-2.8|0.669
73953199|NCT03531905|147439800|SUPERIORITY||Difference of LS means|-1.1|STANDARD_ERROR_OF_MEAN|1.81||0.556|TWO_SIDED|95.0|-4.6|2.5|||ANCOVA|||||2.5|-4.6|0.556
73953200|NCT03531905|147439801|SUPERIORITY||Difference of LS means|2.5|STANDARD_ERROR_OF_MEAN|4.64||0.589|TWO_SIDED|95.0|-6.7|11.7|||ANCOVA|||||11.7|-6.7|0.589
73953201|NCT03531905|147439801|SUPERIORITY||Difference of LS means|0.6|STANDARD_ERROR_OF_MEAN|4.64||0.904|TWO_SIDED|95.0|-8.6|9.7|||ANCOVA|||||9.7|-8.6|0.904
73953202|NCT03531905|147439801|SUPERIORITY||Difference of LS means|2.0|STANDARD_ERROR_OF_MEAN|4.66||0.676|TWO_SIDED|95.0|-7.3|11.2|||ANCOVA|||||11.2|-7.3|0.676
73953203|NCT03531905|147439803|SUPERIORITY||Difference of LS means|-15.8|STANDARD_ERROR_OF_MEAN|13.95||0.258|TWO_SIDED|95.0|-43.4|11.7|||ANCOVA|||||11.7|-43.4|0.258
73953204|NCT03531905|147439803|SUPERIORITY||Difference of LS means|0.5|STANDARD_ERROR_OF_MEAN|13.79||0.972|TWO_SIDED|95.0|-26.8|27.7|||ANCOVA|||||27.7|-26.8|0.972
73953205|NCT03531905|147439803|SUPERIORITY||Difference of LS means|-16.3|STANDARD_ERROR_OF_MEAN|13.68||0.235|TWO_SIDED|95.0|-43.3|10.7|||ANCOVA|||||10.7|-43.3|0.235
73953206|NCT01646320|147439825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.0964|<|0.0001|TWO_SIDED|95.0|-0.91|-0.53||Tested at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-0.53|-0.91|<0.0001
73953207|NCT01646320|147439826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.5|STANDARD_ERROR_OF_MEAN|4.015|<|0.0001|TWO_SIDED|95.0|-35.4|-19.6||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-19.6|-35.4|<0.0001
73953208|NCT01646320|147439827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|STANDARD_ERROR_OF_MEAN|5.493|<|0.0001|TWO_SIDED|95.0|-46.3|-24.7||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-24.7|-46.3|<0.0001
73980625|NCT00666705|147506417|SUPERIORITY_OR_OTHER||Ratio (percent)|90.33||||||90.0|85.28|95.68|||Mixed Models Analysis|Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups.||95.68|85.28|
73980626|NCT00666705|147506418|SUPERIORITY_OR_OTHER||Ratio (percent)|66.77||||||90.0|41.22|108.15|||Mixed Models Analysis|Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.293) on the natural log scale for Cmax, with 90% coverage probability.||108.15|41.22|
73980627|NCT00666705|147506419|SUPERIORITY_OR_OTHER||ratio (percent)|72.42||||||90.0|57.82|90.71|||Mixed Models Analysis|Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|||90.71|57.82|
74033159|NCT01953328|147619129|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|15.2|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|9.87|20.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||20.52|9.87|<0.001
74033160|NCT01953328|147619129|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|16.85|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|10.74|22.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||22.95|10.74|<0.001
74033161|NCT01953328|147619129|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|10.2|STANDARD_ERROR_OF_MEAN|2.7||0.001|TWO_SIDED|95.0|4.85|15.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||15.55|4.85|0.001
74033162|NCT01953328|147619130|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.85|STANDARD_ERROR_OF_MEAN|5.8|<|0.001|TWO_SIDED|95.0|-39.37|-16.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-16.34|-39.37|<0.001
74033163|NCT01953328|147619130|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.65|STANDARD_ERROR_OF_MEAN|5.17|<|0.001|TWO_SIDED|95.0|-32.91|-12.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-12.39|-32.91|<0.001
74033164|NCT01953328|147619130|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-18.09|STANDARD_ERROR_OF_MEAN|4.69||0.001|TWO_SIDED|95.0|-27.4|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.77|-27.40|0.001
73873266|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73980628|NCT01109979|147506420|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
73980629|NCT03456856|147506427|SUPERIORITY||least square mean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.7||0.013|TWO_SIDED|95.0|-8.0|-1.0|||repeated measures linear model|||The estimated mean treatment difference (95% CI) takes into account a presumed -5 bpm change from baseline heart rate in the absence of ivabradine (as seen in the placebo group in the SHIFT study, (NCT02441218, PMID 20801500).||-1.0|-8.0|0.013
74033165|NCT01953328|147619130|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.16|STANDARD_ERROR_OF_MEAN|6.12|<|0.001|TWO_SIDED|95.0|-39.31|-15.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-15.01|-39.31|<0.001
74033166|NCT01953328|147619131|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-28.42|STANDARD_ERROR_OF_MEAN|7.08|<|0.001|TWO_SIDED|95.0|-42.48|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-14.36|-42.48|<0.001
74033167|NCT01953328|147619131|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.81|STANDARD_ERROR_OF_MEAN|5.78|<|0.001|TWO_SIDED|95.0|-32.29|-9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-9.33|-32.29|<0.001
74033168|NCT01953328|147619131|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-15.05|STANDARD_ERROR_OF_MEAN|5.37||0.001|TWO_SIDED|95.0|-25.72|-4.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-4.39|-25.72|0.001
74033169|NCT01953328|147619131|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-24.35|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-36.7|-11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-11.99|-36.70|<0.001
73873267|NCT01128426|147289441|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
73873268|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873269|NCT01128426|147289442|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873270|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73873271|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
73953209|NCT01646320|147439828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.3126|<|0.0001|TWO_SIDED|95.0|-2.12|-0.89||Secondary endpoints are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-0.89|-2.12|<0.0001
73953210|NCT01646320|147439829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.5|||<|0.0001|TWO_SIDED|95.0|16.7|34.4||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||34.4|16.7|<0.0001
74033170|NCT02364947|147619134|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.34|STANDARD_ERROR_OF_MEAN|0.87||0.0001|TWO_SIDED|95.0|-6.05|-2.62||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis|||||-2.62|-6.05|0.0001
73953211|NCT05257837|147439854|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
73873272|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.86
73873273|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
73873274|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873275|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
73873276|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73953212|NCT05257837|147439855|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
73953213|NCT05257837|147439856|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||.012
73953214|NCT05257837|147439858|SUPERIORITY|||||||0.217|||||||t-test, 2 sided|||||||.217
73953215|NCT05257837|147439859|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||.745
73953216|NCT00839982|147439886|SUPERIORITY|||||||0.03||||||Hypothesis: achieving CR provides an overall longer survival.|Chi-squared|||||||0.03
73953217|NCT02118714|147439909|OTHER||Percentage of Participants|23.5|||||TWO_SIDED|80.0|10.7|41.6||||||||41.6|10.7|
73953218|NCT02118714|147439909|OTHER||Percentage of Participants|23.5|||||TWO_SIDED|95.0|6.8|49.9||||||||49.9|6.8|
73953219|NCT02118714|147439910|OTHER||Percentage of Participants|11.8|||||TWO_SIDED|80.0|3.2|28.4||||||||28.4|3.2|
73953220|NCT02118714|147439910|OTHER||Percentage of Participants|11.8|||||TWO_SIDED|95.0|1.5|36.4||||||||36.4|1.5|
73953221|NCT02954575|147439920|OTHER||Poisson test estimate|2.13|||<|0.0001|TWO_SIDED|95.0|1.64|2.76||versus mean TABR \>29|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean annualized bleeding rate (ABR) in patients treated prophylactically with Wilate was below the threshold of 29 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the TABR reported in the GENA-01 study (NCT00989196), which observed 58.1 BEs per patient per year. A corresponding two-sided 95% CI for the TABR was also analyzed.||2.76|1.64|<0.0001
73953222|NCT02954575|147439921|OTHER||Poisson test estimate|1.53|||<|0.0001|TWO_SIDED|95.0|1.13|2.08||versus mean SABR \>19.1|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean SABR in patients treated prophylactically with Wilate was below the threshold of 19.1 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the SABR in the GENA-01 study (NCT00989196), which observed 38.2 spontaneous BEs per patient per year. A corresponding two-sided 95% CI for the SABR was also analyzed.||2.08|1.13|<0.0001
73953223|NCT02954575|147439922|OTHER||Generalized estimation equation|84.21||||0.0096|TWO_SIDED|95.0|72.13|92.52|||Confirmatory data analysis|||"Confirmatory statistical testing tested the null hypotheses that the percentage of success is ≤70% (alternative hypothesis: percentage \>70%); the test procedure based on the generalized estimation equation took into account several BEs in one patient as correlated repeated measurements (alpha = 2.5%). Thus, π denotes the proportion of success and the following pair of hypotheses was tested:~H0: π ≤ 0.7 vs. H1: π \> 0.7"||92.52|72.13|0.0096
73953224|NCT02954575|147439928|OTHER|||||||0.0346|||||||ANOVA|||||||0.0346
73953225|NCT02954575|147439929|OTHER|||||||0.4244|||||||ANOVA|||||||0.4244
73953226|NCT02954575|147439931|OTHER||Pearson-Copper|0.0|||||TWO_SIDED|95.0|0.0|16.11||||||||16.11|0|
74039492|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.5||0.0507|TWO_SIDED|95.0|-1.94|0.0|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.00|-1.94|0.0507
73873277|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73953227|NCT02400307|147439937|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|Geometric Least-Square Mean (GLSM) Ratio|72.63|||||TWO_SIDED|90.0|48.8|108.1||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.10|48.80|
73953228|NCT02400307|147439938|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.29|||||TWO_SIDED|90.0|79.49|124.04||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||124.04|79.49|
73953229|NCT02400307|147439939|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|72.43|||||TWO_SIDED|90.0|48.54|108.07||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.07|48.54|
73953230|NCT02400307|147439940|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.02|||||TWO_SIDED|90.0|79.24|123.74||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||123.74|79.24|
73953231|NCT02400307|147439941|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|80.32|||||TWO_SIDED|90.0|59.56|108.3||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.30|59.56|
73953232|NCT02400307|147439942|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|109.8|||||TWO_SIDED|90.0|87.46|137.85||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||137.85|87.46|
73953233|NCT01656759|147439990|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||||||0.2
73980630|NCT02137785|147506451|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center||A hierarchical procedure was used to control the level of significance. If the primary analysis was sig (p≤0.05), then AKCR at Week 12 were to be compared. If this analysis was significant, then the AKCR at Week 8 were to be compared. If this analysis was significant, then the CCR at Week 8 was to be compared.||||0.0001
73980631|NCT02137785|147506452|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction||||||<0.0001
74039493|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.51||0.248|TWO_SIDED|95.0|-1.6|0.41|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.41|-1.60|0.2480
73953234|NCT01656759|147439991|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
73953235|NCT01656759|147439993|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
73953236|NCT03552978|147440169|SUPERIORITY||Odds Ratio (OR)|11.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|df - 63||||||<.001
73953237|NCT03552978|147440170|SUPERIORITY||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED||||||t-test, 2 sided|df = 59||||||<.001
73953238|NCT03552978|147440174|SUPERIORITY||Mean Difference (Final Values)|90.28||||0.39|TWO_SIDED||||||Mixed Models Analysis|df = 3, 152.11||We examined total Cigarettes smoked in the past 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in cigarette use over time by treatment group.||||.39
73953239|NCT03552978|147440175|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.91|TWO_SIDED||||||Mixed Models Analysis|df = 3, 140.87||We examined days of e-cigarette use in the previous 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in e-cigarette use over time by treatment group.||||.91
73980632|NCT02137785|147506453|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction||||||<0.0001
73873278|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873279|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73953240|NCT03552978|147440176|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.66|TWO_SIDED||||||Mixed Models Analysis|df = 3,199||We examined days of chewing tobacco use in the previous 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in chewing tobacco use over time by treatment group.||||.66
73953241|NCT03552978|147440177|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.76|TWO_SIDED||||||Mixed Models Analysis|df = 3, 102.04||We examined nicotine dependence using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in nicotine dependence over time by treatment group.||||.76
73953242|NCT03552978|147440178|SUPERIORITY||Odds Ratio (OR)|1.99||||0.28|TWO_SIDED|||||Week 12|Chi-squared|df = 1||||||.28
73953243|NCT03552978|147440178|SUPERIORITY||Odds Ratio (OR)|2.3||||0.19|TWO_SIDED|||||Week 24|Chi-squared|df = 1||||||.19
73953244|NCT03552978|147440179|SUPERIORITY||Odds Ratio (OR)|1.68||||0.42|TWO_SIDED||||||Chi-squared|df = 1||Week 12||||.42
73953245|NCT03552978|147440179|SUPERIORITY||Odds Ratio (OR)|2.52||||0.17|TWO_SIDED||||||Chi-squared|df = 1||Week 24||||.17
73953246|NCT03552978|147440180|SUPERIORITY||Mean Difference (Final Values)|3.66||||0.58|TWO_SIDED||||||Mixed Models Analysis|df = 3, 100.51||We examined days of changes in PTSD symptoms using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in PTSD symptoms over time by treatment group.||||.58
73953247|NCT04951479|147440225|SUPERIORITY|||||||0.00041|||||||t-test, 2 sided|||Paired t-test of KOOS Pain score pre and 6 months post embolization||||0.00041
73953248|NCT04951479|147440226|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
73953249|NCT04951479|147440227|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73953250|NCT04951479|147440228|SUPERIORITY|||||||0.00797|||||||t-test, 2 sided|paired t-test||||||0.00797
73953251|NCT00777803|147440292|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Newcombe confidence interval for proportions (paired data) was applied. The lower bound of the Newcombe-Wilson confidence interval of the difference in response rates between groups was compared to the non-inferiority margin of -15%.|difference of response rates|0.7|||||TWO_SIDED|95.0|-3.2|7.1|||||Difference of response rates = response rate in IncobotulinumtoxinA (Xeomin®/Bocouture®) - response rate in OnabotulinumtoxinA (Vistabel®)|Null Hypothesis: Response rate of IncobotulinumtoxinA (Xeomin®/Bocouture®) minus the response rate of OnabotulinumtoxinA (Vistabel®) is lower or equal -15% (non-inferiority margin).||7.1|-3.2|
73953252|NCT01268059|147440307|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.205||||0.027|TWO_SIDED|95.0|1.1|4.5|||Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by histology, disease stage, and ECOG performance status.|Hazard ratio and its 95 percent (%) confidence interval ( CIs) were calculated using the Cox proportional hazard model stratified by histology, disease stage, and Eastern Cooperative Oncology Group (ECOG) performance status.|||4.5|1.1|0.027
73953253|NCT01268059|147440309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.487||||||The 2-sided p-value was calculated by adjusting for the stratification factors histology, disease stage, and Eastern Cooperative Oncology Group (ECOG) performance status.|Cochran-Mantel-Haenszel|||Treatment effect Carboplatin/Paclitaxel + MEDI-575 versus Carboplatin/Paclitaxel.||||0.487
73953254|NCT01268059|147440309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||||||The 2-sided p-value was calculated by adjusting for the stratification factors histology, disease stage, and ECOG performance status.|Cochran-Mantel-Haenszel|||Treatment effect Carboplatin/Paclitaxel + MEDI-575 versus Carboplatin/Paclitaxel.||||0.386
73953255|NCT01268059|147440312|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.017|||||TWO_SIDED|95.0|1.2|7.4|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||7.4|1.2|
73953256|NCT01268059|147440312|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.134|||||TWO_SIDED|95.0|0.3|4.3|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||4.3|0.3|
73953257|NCT01268059|147440313|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.315|||||TWO_SIDED|95.0|0.7|2.4|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||2.4|0.7|
73953258|NCT01268059|147440313|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.083|||||TWO_SIDED|95.0|0.4|10.8|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||10.8|0.4|
73953259|NCT03850444|147440326|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.38|1.0|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||1.00|0.38|
73953260|NCT03850444|147440327|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.41|0.95|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||0.95|0.41|
73953261|NCT03850444|147440328|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.45|0.94|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||0.94|0.45|
73953262|NCT03850444|147440329|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.57|1.28|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||1.28|0.57|
74033171|NCT02364947|147619134|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.18|STANDARD_ERROR_OF_MEAN|0.95||0.0001|TWO_SIDED|95.0|-6.05|-2.32||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis|||||-2.32|-6.05|0.0001
73980633|NCT02137785|147506454|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center||||||0.0001
73980634|NCT02516202|147506521|SUPERIORITY|||||||0.25||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.25
73980635|NCT02516202|147506521|SUPERIORITY|||||||0.31||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.31
73980636|NCT02516202|147506522|SUPERIORITY|||||||0.99||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.99
73980637|NCT02516202|147506522|SUPERIORITY|||||||0.05||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.05
73980638|NCT02516202|147506523|SUPERIORITY|||||||0.64||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.64
73980639|NCT02516202|147506523|SUPERIORITY|||||||0.17||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.17
73980640|NCT02516202|147506525|SUPERIORITY|||||||0.02||||||p-value calculation includes 195 participants with known responses at week 12.|Chi-squared|||||||0.02
73980641|NCT02516202|147506526|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73980642|NCT02516202|147506526|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
73980643|NCT02516202|147506527|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73980644|NCT02516202|147506527|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
73980645|NCT00337610|147506528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.02|STANDARD_DEVIATION|1.19|<|0.001||95.0|-1.36|-0.67|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic agent (AHA) \[medication\] (on Monotherapy AHA or on Metformin-based combination therapy)||||-0.67|-1.36|<0.001
73980646|NCT00337610|147506529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.5|STANDARD_DEVIATION|42.2|<|0.001||95.0|-37.7|-13.3|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-13.3|-37.7|<0.001
73980647|NCT00337610|147506530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.1|STANDARD_DEVIATION|63.8|<|0.001||95.0|-74.7|-33.6|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-33.6|-74.7|<0.001
73980648|NCT00337610|147506531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.01|STANDARD_DEVIATION|1.34|<|0.001||95.0|-1.4|-0.62|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-0.62|-1.40|<0.001
73980649|NCT03979040|147506532|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5||||P value = .025 (one-sided) and sign test below|Sign test|||||||.025
73980650|NCT03979040|147506533|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5|||||Sign test|||||||.025
73980651|NCT03979040|147506534|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5|||||Sign test|||||||.025
73980652|NCT01742832|147506538|OTHER|Linear repeated measures regression models were constructed to assess trends over time between groups where the dependent variable was outcome measure (MADRS score) and independent variables included visit, treatment group, visit by treatment group interaction, and any baseline variables that were significant between groups.||||||0.342||||||P-value for linear regression assessing outcome measure (MADRS score) and treatment group.|Regression, Linear|||||||0.342
74089504|NCT01172821|147731711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.03||0.0002|TWO_SIDED|95.0|0.052|0.168|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.168|0.052|0.0002
73873280|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
73873281|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
73873282|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.88|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.88
73873283|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
73873284|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
74089505|NCT01172821|147731711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.03||0.0031|TWO_SIDED|95.0|0.03|0.147|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.147|0.030|0.0031
73873285|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
73873286|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873287|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873288|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
73873289|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
73873290|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873291|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
73873292|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
73873293|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73953263|NCT03850444|147440330|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.7|1.39|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||1.39|0.70|
73953264|NCT03850444|147440331|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.74|1.35|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||1.35|0.74|
73953265|NCT03850444|147440332|OTHER||Difference in Percentage (DP)|17.2|||||TWO_SIDED|95.0|1.8|31.6|||Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).|||31.6|1.8|
73953266|NCT03850444|147440333|OTHER||Difference in Percentage (DP)|11.3|||||TWO_SIDED|95.0|-1.4|23.7|||||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||23.7|-1.4|
73953267|NCT03850444|147440334|OTHER||Difference in Percentage (DP)|8.0|||||TWO_SIDED|95.0|-3.0|18.9|||||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||18.9|-3.0|
73873294|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
73873295|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
73873296|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873297|NCT01128426|147289442|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873298|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.88|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.88
73873299|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873300|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
74033172|NCT02364947|147619135|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|-5.69|-2.16|||Mixed Models Analysis|||||-2.16|-5.69|<0.0001
73873301|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73873302|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73980653|NCT02102724|147506554|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The null hypotheses were that there are no differences between the two groups' change scores for any study outcomes. The power analysis was based on a study of krill oil for reducing CRP levels in persons with arthritis (N = 90) that yielded an effect size (Cohen's d) of 1.2. A sample size of 37 was determined to yield a power of 0.80 to detect an effect size of 1.0 with a two-tailed alpha of 0.05.|The change scores of the two groups (week 12 minus baseline) were compared using Wilcoxon rank sum tests.|||< 0.05
73980654|NCT02008916|147506557|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0093|TWO_SIDED|95.0|1.24|4.69|||Regression, Logistic|||||4.69|1.24|0.0093
73980655|NCT02008916|147506557|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0037|TWO_SIDED|95.0|1.38|5.21|||Regression, Logistic|||||5.21|1.38|0.0037
73980656|NCT02008916|147506558|SUPERIORITY||Odds Ratio (OR)|2.59||||0.01|TWO_SIDED|95.0|1.26|5.35|||Regression, Logistic|||||5.35|1.26|0.0100
73980657|NCT02008916|147506558|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0051|TWO_SIDED|95.0|1.36|5.78|||Regression, Logistic|||||5.78|1.36|0.0051
73980658|NCT02008916|147506559|SUPERIORITY||Relative treatment effect|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.68|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.|||0.68|0.38|<0.0001
73980659|NCT02008916|147506559|SUPERIORITY||Relative treatment effect|0.44|||<|0.0001|TWO_SIDED|95.0|0.33|0.6|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.|||0.60|0.33|<0.0001
73980660|NCT02008916|147506560|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0002|TWO_SIDED|95.0|2.01|9.92|||Regression, Logistic|||||9.92|2.01|0.0002
73980661|NCT02008916|147506560|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0004|TWO_SIDED|95.0|1.89|9.38|||Regression, Logistic|||||9.38|1.89|0.0004
73980662|NCT02008916|147506561|SUPERIORITY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.39||0.0347|TWO_SIDED|95.0|-1.6|-0.06|||Mixed Models Analysis|||||-0.06|-1.60|0.0347
73980663|NCT02008916|147506561|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.39||0.0018|TWO_SIDED|95.0|-2.0|-0.46|||Mixed Models Analysis|||||-0.46|-2.00|0.0018
73980664|NCT02008916|147506565|SUPERIORITY||Odds Ratio (OR)|7.71||||0.0593|TWO_SIDED|95.0|0.92|64.42|||Regression, Logistic|||||64.42|0.92|0.0593
73980665|NCT02008916|147506565|SUPERIORITY||Odds Ratio (OR)|19.39||||0.0046|TWO_SIDED|95.0|2.49|150.79|||Regression, Logistic|||||150.79|2.49|0.0046
73980666|NCT01450397|147506598|SUPERIORITY_OR_OTHER||||||<|0.0013|||||||t-test, 2 sided|||||||<0.0013
73980667|NCT03060525|147506601|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|1.51||0.026|TWO_SIDED|95.0|-6.32|-0.41|||Mixed Models Analysis|||Difference in weight change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||-0.41|-6.32|0.026
73980668|NCT03060525|147506602|SUPERIORITY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.59||0.03|TWO_SIDED|95.0|-2.42|-0.12|||Mixed Models Analysis|||Difference in Body Mass Index (BMI) change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||-0.12|-2.42|0.03
73980669|NCT03060525|147506603|SUPERIORITY||Median Difference (Net)|247.5||||0.63|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in amount of physical activity = 6-month MET-minutes/week - baseline MET-minutes/week (change from pre to post intervention), using the International Physical Activity Questionnaire. IPAQ score is a continuous measure and reports median MET-minutes per week (a combination of walking met-minutes/week + moderate activity MET-minutes/week + vigorous activity MET-minutes/week). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||||0.63
74033173|NCT02364947|147619135|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.54|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-6.46|-2.63|||Mixed Models Analysis|||||-2.63|-6.46|<0.0001
74033174|NCT02364947|147619136|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.47|STANDARD_ERROR_OF_MEAN|2.72|<|0.0001|TWO_SIDED|95.0|-17.81|-7.13|||Mixed Models Analysis|||Change in total alcohol consumption (TAC) from baseline at Week 12||-7.13|-17.81|<0.0001
74009149|NCT04666350|147569057|OTHER||Combined Difference in Prevalence|-0.016||||0.795|TWO_SIDED|95.0|-0.139|0.107|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.107|-0.139|0.795
74089506|NCT01172821|147731712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.032||0.0061|TWO_SIDED|95.0|0.025|0.149|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.149|0.025|0.0061
73953268|NCT02107274|147440344|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
74089507|NCT01172821|147731712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.032||0.0093|TWO_SIDED|95.0|0.021|0.146|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.146|0.021|0.0093
73873303|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
73953269|NCT02107274|147440344|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
73953270|NCT02107274|147440345|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
73953271|NCT02107274|147440345|SUPERIORITY_OR_OTHER||||||<|0.01||||||p valu of less than 0.05 was considered significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables"||||<0.01
73953272|NCT02107274|147440346|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
73953273|NCT02107274|147440346|SUPERIORITY_OR_OTHER||||||<|0.01||||||p value of less than 0.05 was considered significant|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
73980670|NCT00912964|147506604|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.005|TWO_SIDED|95.0|-0.74|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.06|-0.74|0.005
74009150|NCT04666350|147569058|OTHER||Relative Rate|0.38||||0.019|TWO_SIDED|95.0|0.21|0.7||Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.|Poisson Regression|||Comparison of DSFA Day 2 versus Day 1.||0.70|0.21|0.019
73873304|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.9|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.90
74089508|NCT01172821|147731713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.15|0.252|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.252|0.150|<0.0001
73873305|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
73873306|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
73953274|NCT02107274|147440347|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
73953275|NCT02107274|147440347|SUPERIORITY_OR_OTHER||||||<|0.01||||||p value of less than 0.05 was considered significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
73953276|NCT02941146|147440348|OTHER||sucess proportion|64.3|||||TWO_SIDED|95.0|35.1|87.2||||||||87.2|35.1|
74033175|NCT02364947|147619136|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.94|STANDARD_ERROR_OF_MEAN|2.95|<|0.0001|TWO_SIDED|95.0|-18.72|-7.15|||Mixed Models Analysis|||||-7.15|-18.72|<0.0001
74033176|NCT02364947|147619137|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.15|STANDARD_ERROR_OF_MEAN|2.86||0.0001|TWO_SIDED|95.0|-16.77|-5.53|||Mixed Models Analysis|||||-5.53|-16.77|0.0001
74033177|NCT02364947|147619137|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.27|STANDARD_ERROR_OF_MEAN|3.11||0.0003|TWO_SIDED|95.0|-17.37|-5.17|||Mixed Models Analysis|||||-5.17|-17.37|0.0003
73873307|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
74033178|NCT02364947|147619138|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|22.0|||<|0.0001|TWO_SIDED|95.0|13.6|30.4|||Cochran-Mantel-Haenszel|||||30.4|13.6|<0.0001
74033179|NCT02364947|147619138|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|15.7||||0.0007|TWO_SIDED|95.0|6.5|25.0|||Cochran-Mantel-Haenszel|||||25.0|6.5|0.0007
74033180|NCT02364947|147619139|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|18.0||||0.0002|TWO_SIDED|95.0|8.8|27.2|||Cochran-Mantel-Haenszel|||||27.2|8.8|0.0002
74033181|NCT02364947|147619139|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|20.6||||0.0001|TWO_SIDED|95.0|10.4|30.8|||Cochran-Mantel-Haenszel|||||30.8|10.4|0.0001
74033182|NCT02364947|147619140|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|17.8|||<|0.0001|TWO_SIDED|95.0|10.5|25.1|||Cochran-Mantel-Haenszel|||||25.1|10.5|<0.0001
74033183|NCT02364947|147619140|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.3||||0.0002|TWO_SIDED|95.0|6.4|22.2|||Cochran-Mantel-Haenszel|||||22.2|6.4|0.0002
74033184|NCT02364947|147619141|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|11.0||||0.0079|TWO_SIDED|95.0|2.9|19.1|||Cochran-Mantel-Haenszel|||||19.1|2.9|0.0079
74033185|NCT02364947|147619141|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.8||||0.001|TWO_SIDED|95.0|5.8|23.9|||Cochran-Mantel-Haenszel|||||23.9|5.8|0.0010
74033186|NCT02364947|147619142|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|9.9||||0.0022|TWO_SIDED|95.0|3.5|16.3|||Cochran-Mantel-Haenszel|||||16.3|3.5|0.0022
74033187|NCT02364947|147619142|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|11.1||||0.0016|TWO_SIDED|95.0|3.8|18.3|||Cochran-Mantel-Haenszel|||||18.3|3.8|0.0016
74033188|NCT02364947|147619143|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|13.6||||0.0003|TWO_SIDED|95.0|6.2|20.9|||Cochran-Mantel-Haenszel|||||20.9|6.2|0.0003
74033189|NCT02364947|147619143|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|12.8||||0.0013|TWO_SIDED|95.0|4.6|21.0|||Cochran-Mantel-Haenszel|||||21.0|4.6|0.0013
74033190|NCT02364947|147619144|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|15.2||||0.0002|TWO_SIDED|95.0|7.1|23.3|||Cochran-Mantel-Haenszel|||||23.3|7.1|0.0002
74033191|NCT02364947|147619144|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|17.9||||0.0001|TWO_SIDED|95.0|8.9|26.9|||Cochran-Mantel-Haenszel|||||26.9|8.9|0.0001
74033192|NCT02364947|147619145|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|8.0||||0.0724|TWO_SIDED|95.0|-0.7|16.7|||Cochran-Mantel-Haenszel|||||16.7|-0.7|0.0724
74033193|NCT02364947|147619145|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|19.6||||0.0001|TWO_SIDED|95.0|9.9|29.2|||Cochran-Mantel-Haenszel|||||29.2|9.9|0.0001
74033194|NCT02364947|147619146|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.07||0.0002|TWO_SIDED|95.0|-0.4|-0.13|||Mixed Models Analysis|||||-0.13|-0.40|0.0002
74033195|NCT02364947|147619146|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08||0.0001|TWO_SIDED|95.0|-0.45|-0.15|||Mixed Models Analysis|||||-0.15|-0.45|0.0001
74033196|NCT02364947|147619147|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.48|-0.18|||Mixed Models Analysis|||||-0.18|-0.48|<0.0001
74033197|NCT02364947|147619147|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.51|-0.19|||Mixed Models Analysis|||||-0.19|-0.51|<0.0001
73953277|NCT02424344|147440376|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.125||||0.069|TWO_SIDED|95.0|-0.259|0.01|||ANCOVA|Adjusted by baseline and age as covariates, and treatment group, sex and smoking-status as fixed effect factors||||0.010|-0.259|0.069
73953278|NCT00519779|147440482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0033|STANDARD_ERROR_OF_MEAN|0.09||0.97|TWO_SIDED|95.0|-0.18|0.18|||Mixed Models Analysis|adjusted for baseline value, visit, gender, SAD||||0.18|-0.18|0.97
73953279|NCT00519779|147440483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.04|TWO_SIDED|95.0|-0.44|-0.011|||Mixed Models Analysis|||||-0.011|-0.44|0.04
73953280|NCT00519779|147440484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.039||0.06|TWO_SIDED|95.0|-0.15|0.002|||Mixed Models Analysis|||||0.002|-0.15|0.06
73953281|NCT00519779|147440485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.072||0.04|TWO_SIDED|95.0|-0.3|-0.009|||Mixed Models Analysis|||||-0.009|-0.30|0.04
73953282|NCT00519779|147440486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.086||0.08|TWO_SIDED|95.0|-0.33|0.018|||Mixed Models Analysis|||||0.018|-0.33|0.08
73953283|NCT00519779|147440487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.14||0.93|TWO_SIDED|95.0|-0.26|0.29|||Mixed Models Analysis|||||0.29|-0.26|0.93
74009151|NCT04666350|147569058|OTHER||Relative Rate|0.23||||0.003|TWO_SIDED|95.0|0.11|0.45||Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.|Poisson Regression|||Comparison of DMFA Day 2 versus Day 1.||0.45|0.11|0.003
74033198|NCT02364947|147619148|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.69|-0.33|||Mixed Models Analysis|||||-0.33|-0.69|<0.0001
73953284|NCT05677867|147440497|OTHER||Ratio of Adjusted Geometric Means|97.4|||||TWO_SIDED|90.0|92.92|102.08|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% Confidence Intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||102.08|92.92|
73953285|NCT05677867|147440498|OTHER||Ratio of Geometric Adjusted Means|97.36|||||TWO_SIDED|90.0|92.77|102.17|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||102.17|92.77|
73953286|NCT05677867|147440499|OTHER||Ratio of Adjusted Means|94.7|||||TWO_SIDED|90.0|81.4|110.18|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||110.18|81.40|
73953287|NCT04081298|147440523|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.8||0.24|TWO_SIDED|||||The threshold for statistical significance is p=0.05. (feasibility assessment)|Paired sample t-test|||||||0.24
73953288|NCT04081298|147440524|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.14|STANDARD_DEVIATION|0.78||0.43|TWO_SIDED|||||The threshold for statistical significance was p=0.5 (feasibility assessment)|paired t-test|||||||0.43
73953289|NCT04081298|147440525|EQUIVALENCE|McNemar's test evaluates equivalence between nominal groups. Power not calculated as this is a feasibility study with small sample size.||||||0.1|||||||McNemar|||Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)||||0.10
73953290|NCT04081298|147440526|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.65||0.2|TWO_SIDED|||||The threshold for statistical significance was p=0.5 (feasibility assessment)|paired-sample t-test|||||||0.20
73953291|NCT04081298|147440527|EQUIVALENCE|paired sample t-test (feasibility assessment)|Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.73||0.71|TWO_SIDED||||||paired sample t-test|||||||0.71
73953292|NCT04081298|147440528|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.94|||||||paired-sample t-test|||Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)||||0.94
73953293|NCT04081298|147440529|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up using a paired-sample t-test. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.03|||||||paired-sample t-test|||||||0.03
73953294|NCT04081298|147440530|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up using a paired-sample t-test. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.36|||||||paired-sample t-test|||||||0.36
73953295|NCT02059161|147440531|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for declaring non-inferiority was for the upper bound of the 95% CI to lie below 0.4%.|Difference in the Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.11|0.19|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.19|-0.11|
73953296|NCT02059161|147440532|SUPERIORITY_OR_OTHER||Difference in the Percentages|-3.9|||||TWO_SIDED|95.0|-11.8|4.0|||||Miettinen \& Nurminen|||4.0|-11.8|
73953297|NCT02059161|147440533|SUPERIORITY_OR_OTHER||Difference in Percentages|-3.0|||||TWO_SIDED|95.0|-16.1|10.1|||||Miettinen \& Nurminen|||10.1|-16.1|
73873308|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
74033199|NCT02364947|147619148|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.27|||Mixed Models Analysis|||||-0.27|-0.67|<0.0001
74033200|NCT02364947|147619149|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.7|-0.31|||Mixed Models Analysis|||||-0.31|-0.70|<0.0001
74033201|NCT02364947|147619149|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.77|-0.33|||Mixed Models Analysis|||||-0.33|-0.77|<0.0001
74033202|NCT02364947|147619150|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.192|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|-0.262|-0.121|||Mixed Models Analysis|||||-0.121|-0.262|<0.0001
74033203|NCT02364947|147619150|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.156|STANDARD_ERROR_OF_MEAN|0.039||0.0001|TWO_SIDED|95.0|-0.232|-0.08|||Mixed Models Analysis|||||-0.080|-0.232|0.0001
74033204|NCT02364947|147619151|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.168|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.248|-0.088|||Mixed Models Analysis|||||-0.088|-0.248|<0.0001
74033205|NCT02364947|147619151|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.139|STANDARD_ERROR_OF_MEAN|0.044||0.0017|TWO_SIDED|95.0|-0.226|-0.052|||Mixed Models Analysis|||||-0.052|-0.226|0.0017
73873309|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
73953298|NCT02059161|147440536|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.18|0.14|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.14|-0.18|
73953299|NCT02059161|147440537|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.77|||||TWO_SIDED|95.0|-4.69|1.16|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.16|-4.69|
74033206|NCT02364947|147619152|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.031||0.0234|TWO_SIDED|95.0|-0.13|-0.009|||Mixed Models Analysis|||||-0.009|-0.130|0.0234
74033207|NCT02364947|147619152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.033||0.1374|TWO_SIDED|95.0|-0.115|0.016|||Mixed Models Analysis|||Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.||0.016|-0.115|0.1374
73953300|NCT02059161|147440538|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.06|0.01|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.06|
74033208|NCT02364947|147619153|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.031||0.0348|TWO_SIDED|95.0|-0.127|-0.005|||Mixed Models Analysis|||||-0.005|-0.127|0.0348
74033209|NCT02364947|147619153|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.034||0.1444|TWO_SIDED|95.0|-0.116|0.017|||Mixed Models Analysis|||||0.017|-0.116|0.1444
74033210|NCT02163993|147619154|SUPERIORITY||Posterior Mean Difference|-0.57|STANDARD_DEVIATION|0.42|||TWO_SIDED|95.0|-1.4|0.24|||Bayesian Dose Response Model|||||0.24|-1.40|
74033211|NCT02163993|147619154|SUPERIORITY||Posterior Mean Difference|-0.25|STANDARD_DEVIATION|0.41|||TWO_SIDED|95.0|-1.06|0.56|||Bayesian Dose Response Model|||||0.56|-1.06|
74033212|NCT02163993|147619154|SUPERIORITY||Posterior Mean Difference|-1.14|STANDARD_DEVIATION|0.44|||TWO_SIDED|95.0|-2.02|-0.29|||Bayesian Dose Response Model|||||-0.29|-2.02|
73873310|NCT01128426|147289442|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
74033213|NCT02163993|147619154|SUPERIORITY||Posterior Mean Difference|-0.62|STANDARD_DEVIATION|0.45|||TWO_SIDED|95.0|-1.5|0.27|||Bayesian Dose Response Model|||||0.27|-1.50|
74089509|NCT01172821|147731713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.112|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.215|0.112|<0.0001
74089510|NCT01172821|147731714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|STANDARD_ERROR_OF_MEAN|0.029||0.0002|TWO_SIDED|95.0|0.052|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.164|0.052|0.0002
73873311|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
73873312|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.49|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.49
73953301|NCT02059161|147440539|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|9.6|||||TWO_SIDED|95.0|-3.0|22.2|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||22.2|-3.0|
73953302|NCT02059161|147440540|SUPERIORITY_OR_OTHER||Differences in Percentages|-2.1|||||TWO_SIDED|95.0|-9.8|5.5|||||Miettinen \& Nurminen|||5.5|-9.8|
73953303|NCT02059161|147440541|SUPERIORITY_OR_OTHER||Difference in Percentages|0.8|||||TWO_SIDED|95.0|-12.8|14.3|||||Miettinen \& Nurminen|||14.3|-12.8|
73953304|NCT02059161|147440543|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.77|||||TWO_SIDED|95.0|-4.92|1.39|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.39|-4.92|
73953305|NCT02059161|147440544|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.02|||||TWO_SIDED|95.0|-0.05|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.02|-0.05|
73953306|NCT02059161|147440545|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.4|||||TWO_SIDED|95.0|-19.7|8.9|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||8.9|-19.7|
73953307|NCT02059161|147440547|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.4|||||TWO_SIDED|95.0|-8.9|8.2|||||Longitudinal data analysis model including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||8.2|-8.9|
73953308|NCT02059161|147440548|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-8.1|||||TWO_SIDED|95.0|-18.6|2.4|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||2.4|-18.6|
73953309|NCT02059161|147440549|SUPERIORITY_OR_OTHER||Adjusted Difference in %s (A1C < 7.0%)|-0.8|||||TWO_SIDED|95.0|-9.7|8.1|||||Miettinen and Nurminen, stratified by prior insulin status.|||8.1|-9.7|
73953310|NCT02059161|147440549|SUPERIORITY_OR_OTHER||Adjusted Difference in %s (A1C <6.5%)|-1.1|||||TWO_SIDED|95.0|-8.6|6.5|||||Miettinen and Nurminen, stratified by prior insulin status.|||6.5|-8.6|
73953311|NCT02059161|147440550|SUPERIORITY_OR_OTHER||Adjusted Difference (A1C < 7.0%)|0.2|||||TWO_SIDED|95.0|-8.7|9.1|||||Miettinen and Nurminen|||9.1|-8.7|
73953312|NCT02059161|147440550|SUPERIORITY_OR_OTHER||Adjusted Difference (A1C < 6.5%)|-4.4|||||TWO_SIDED|95.0|-11.5|2.8|||||Miettinen and Nurminen|||2.8|-11.5|
73953313|NCT02059161|147440551|SUPERIORITY_OR_OTHER||Difference in Least Means Squares|-0.42|||||TWO_SIDED|95.0|-2.33|1.48|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.48|-2.33|
73953314|NCT02059161|147440552|SUPERIORITY_OR_OTHER||Difference in Least Means Squares|0.0|||||TWO_SIDED|95.0|-0.02|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.02|-0.02|
73953315|NCT02059161|147440553|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.5|||||TWO_SIDED|95.0|-3.69|0.69|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.69|-3.69|
73953316|NCT02059161|147440554|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02||||||95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.04|
74033214|NCT01441440|147619176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.031|TWO_SIDED|95.0|0.14|2.87||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||2.87|0.14|0.031
74033215|NCT01441440|147619176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.12||||0.106|TWO_SIDED|95.0|-0.24|2.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||2.48|-0.24|0.106
73980671|NCT00912964|147506604|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.001|TWO_SIDED|95.0|-0.76|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.08|-0.76|0.001
73980672|NCT00912964|147506605|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6||||0.15|TWO_SIDED|95.0|-1.6|10.8||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||10.8|-1.6|0.15
73980673|NCT00912964|147506605|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.4|||<|0.001|TWO_SIDED|95.0|6.3|18.6||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||18.6|6.3|<0.001
73980674|NCT00912964|147506606|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47||||0.007|TWO_SIDED|95.0|-0.82|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.82|0.007
73980675|NCT00912964|147506606|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.015|TWO_SIDED|95.0|-0.76|-0.08||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.08|-0.76|0.015
73980676|NCT00912964|147506607|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34||||0.039|TWO_SIDED|95.0|-0.68|-0.01||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.01|-0.68|0.039
73980677|NCT00912964|147506607|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.85|-0.17||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.17|-0.85|<0.001
73980678|NCT00912964|147506608|SUPERIORITY_OR_OTHER_LEGACY||LS Difference|-0.18||||0.3|TWO_SIDED|95.0|-0.53|0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.16|-0.53|0.30
73980679|NCT00912964|147506608|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.37||||0.035|TWO_SIDED|95.0|-0.71|-0.03||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.03|-0.71|0.035
73873313|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
73980680|NCT00912964|147506609|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.07||||0.083|TWO_SIDED|95.0|-0.15|0.01||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.01|-0.15|0.083
73980681|NCT00912964|147506609|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|||<|0.001|TWO_SIDED|95.0|-0.22|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.06|-0.22|<0.001
73980682|NCT00912964|147506610|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36||||0.004|TWO_SIDED|95.0|-0.67|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.05|-0.67|0.004
73980683|NCT00912964|147506610|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39||||0.002|TWO_SIDED|95.0|-0.69|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.08|-0.69|0.002
73980684|NCT00912964|147506611|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33||||0.13|TWO_SIDED|95.0|-0.76|0.1||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.10|-0.76|0.13
73980685|NCT00912964|147506611|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59||||0.007|TWO_SIDED|95.0|-1.01|-0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.16|-1.01|0.007
73980686|NCT04919499|147506648|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|-0.0252|STANDARD_ERROR_OF_MEAN|0.0376|||TWO_SIDED|95.0|-0.1048|0.0545|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0545|-0.1048|
73980687|NCT04919499|147506649|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|-0.0101|STANDARD_ERROR_OF_MEAN|0.0236|||TWO_SIDED|95.0|-0.0625|0.0422|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0422|-0.0625|
73980688|NCT04919499|147506650|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|0.0016|STANDARD_ERROR_OF_MEAN|0.0181|||TWO_SIDED|95.0|-0.0504|0.0536|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0536|-0.0504|
73980689|NCT04919499|147506651|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-4.7|5.0|||||"Calculated as \[high-dose BI 765128\] - \[Sham\]~Results were rounded to one decimal place."|||5.0|-4.7|
73980690|NCT04620733|147506686|SUPERIORITY||Risk Difference (RD)|41.7|||<|0.0001|TWO_SIDED|95.0|27.7|53.4||Two-sided p-value for pair-wise comparison was based on the CMH test adjusted for both randomization stratification variables (baseline ALP level: \< 350 U/L and ≥ 350 U/L; baseline Pruritus NRS: \< 4 and ≥ 4).|Cochran-Mantel-Haenszel|||||53.4|27.7|< 0.0001
73980691|NCT04620733|147506689|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.0001|TWO_SIDED|95.0|18.3|33.2|||Cochran-Mantel-Haenszel||Two-sided p-value for pair-wise comparison is based on the Cochran Mantel Haenszel test adjusted for both stratification variables (baseline ALP level: \< 350 U/L and \>= 350 U/L; baseline pruritus NRS: \< 4 and \>= 4).|||33.2|18.3|< 0.0001
73980692|NCT04620733|147506690|SUPERIORITY||Least Squares (LS) Mean Difference|-1.5||||0.0047|TWO_SIDED|95.0|-2.5|-0.5|||MMRM|Mixed-Effect Model Repeated Measure (MMRM)||||-0.5|-2.5|0.0047
73980693|NCT02507297|147506695|SUPERIORITY|||||||0.367|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.367
73980694|NCT02507297|147506695|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.48
73980695|NCT02507297|147506696|SUPERIORITY|||||||0.136|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.136
73980696|NCT02507297|147506696|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.324
73980697|NCT02507297|147506697|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.916
73980698|NCT02507297|147506697|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.752
73980699|NCT02507297|147506698|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.568
74033216|NCT01441440|147619177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.88||||0.008|TWO_SIDED|95.0|0.77|5.0||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||5.00|0.77|0.008
73980700|NCT02507297|147506698|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.568
73980701|NCT02507297|147506699|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||||||.486
73980702|NCT02489799|147506701|EQUIVALENCE|The study was powered based on two former studies utilizing RIAS, (both powered =.8 and alpha =.05). With a 0.6 effect size, the required sample size is 72 patients (36 per group) for a one-tailed test of study hypotheses (power =.8 and alpha =.05).|Incidence Rate Ratio|1.06||||0.545|TWO_SIDED|95.0|0.87|1.3|||Poisson model using GEE|We fit a Poisson model using generalized estimating equations. No adjustments were made for degrees of freedom.|The incidence rate ratio compares intervention to control.|We employed two ways of interpreting this data. The first treats the outcome continuously, which is described in the results section. Here we describe the outcome treating it as a ratio. We created a variable representing the numerator of the ratio (type 1) and the denominator of the ratio (type 2) thereby treating the information in both the numerator and denominator as random (each a Poisson variable).||1.30|0.87|0.545
73980703|NCT02580799|147506790|SUPERIORITY_OR_OTHER||||||=|0.137|TWO_SIDED||||||Chi-squared|||Site A: Site B variability assessment||||=0.137
73980704|NCT02580799|147506790|SUPERIORITY_OR_OTHER||||||=|0.454|TWO_SIDED||||||Chi-squared|||Site A: Site C variability assessment||||=0.454
73980705|NCT02580799|147506790|SUPERIORITY_OR_OTHER||||||=|0.211|TWO_SIDED||||||Chi-squared|||Site A: Site D variability assessment||||=0.211
73980706|NCT02580799|147506790|SUPERIORITY_OR_OTHER||||||=|0.294|TWO_SIDED||||||Chi-squared|||Site A: Site E variability assessment||||=0.294
73980707|NCT02580799|147506792|SUPERIORITY_OR_OTHER||||||=|0.054|TWO_SIDED||||||Chi-squared|||Site B: Site C variability assessment||||=0.054
73980708|NCT02580799|147506792|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Chi-squared|||Site B: Site D variability assessment||||=1.000
73980709|NCT02580799|147506792|SUPERIORITY_OR_OTHER||||||=|0.968|TWO_SIDED||||||Chi-squared|||Site B: Site E variability assessment||||=0.968
73980710|NCT02580799|147506805|SUPERIORITY_OR_OTHER||||||=|0.246|TWO_SIDED||||||Chi-squared|||Site C: Site D variability assessment||||=0.246
73980711|NCT02580799|147506805|SUPERIORITY_OR_OTHER||||||=|0.032|TWO_SIDED||||||Chi-squared|||Site C: Site E variability assessment||||=0.032
73980712|NCT02580799|147506805|SUPERIORITY_OR_OTHER||||||=|0.007|TWO_SIDED||||||Chi-squared|||Site D: Site E variability assessment||||=0.007
73980713|NCT02580799|147506807|SUPERIORITY_OR_OTHER||||||=|0.988|TWO_SIDED||||||Chi-squared|||Abroad: Site A variability assessment||||=0.988
73980714|NCT02580799|147506807|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Chi-squared|||Abroad: Site B variability assessment||||=0.008
73980715|NCT02580799|147506807|SUPERIORITY_OR_OTHER||||||=|0.031|TWO_SIDED||||||Chi-squared|||Abroad: Site C variability assessment||||=0.031
73980716|NCT02580799|147506807|SUPERIORITY_OR_OTHER||||||=|0.554|TWO_SIDED||||||Chi-squared|||Abroad: Site D variability assessment||||=0.554
73980717|NCT02580799|147506807|SUPERIORITY_OR_OTHER||||||=|0.709|TWO_SIDED||||||Chi-squared|||Abroad: Site E variability assessment||||=0.709
73980718|NCT03693989|147506823|OTHER|||||||0.065|||||||t-test, 2 sided|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.065
73980719|NCT03693989|147506824|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.223|||||||t-test, 2 sided|||||||0.223
73980720|NCT03693989|147506825|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.621|||||||Chi-squared, Corrected|||||||0.621
73980721|NCT03693989|147506826|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.246|||||||Fisher Exact|||||||0.246
73980722|NCT03693989|147506827|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact|||||||0.497
73980723|NCT03693989|147506828|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.047|||||||t-test, 2 sided|||||||0.047
73980724|NCT03693989|147506829|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.3|||||||Chi-squared, Corrected|||||||0.300
73873314|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873315|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873316|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873317|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
73873318|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73953317|NCT02059161|147440555|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.74|||||TWO_SIDED|95.0|-2.52|1.04|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.04|-2.52|
73980725|NCT03693989|147506830|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.045|||||||t-test, 2 sided|||||||0.045
73980726|NCT03693989|147506831|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.346|||||||Fisher Exact|||burning eyes comparison||||0.346
73980727|NCT03693989|147506831|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.489|||||||Fisher Exact|||Itching eyes comparison||||0.489
73980728|NCT03693989|147506831|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact|||foreign body sensation eyes comparison||||0.497
73980729|NCT03693989|147506831|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||1|||||||Fisher Exact|||blurred vision comparison||||1.000
73980730|NCT03403153|147506857|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
73980731|NCT03403153|147506858|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
73980732|NCT03403153|147506859|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
73980733|NCT03403153|147506860|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
73980734|NCT03403153|147506861|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
73980735|NCT03403153|147506862|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
73980736|NCT03403153|147506863|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
73980737|NCT00113529|147506864|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|37.1||||||95.0|21.5|55.1|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.|||55.1|21.5|
73980738|NCT00113529|147506870|SUPERIORITY_OR_OTHER||probability|82.4||||||95.0|64.9|91.7||||||||91.7|64.9|
73873319|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
73873320|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73953318|NCT02059161|147440556|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.01|||||TWO_SIDED|95.0|-0.03|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.03|
73953319|NCT02059161|147440557|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.25|||||TWO_SIDED|95.0|-3.34|0.83|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.83|-3.34|
73980739|NCT00113529|147506879|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.075
73980740|NCT00113529|147506879|SUPERIORITY_OR_OTHER|||||||0.749||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.749
73980741|NCT00113529|147506879|SUPERIORITY_OR_OTHER|||||||0.834||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.834
73873321|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73873322|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
73873323|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
73980742|NCT00113529|147506879|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||1.000
73980743|NCT00113529|147506879|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.332
73980744|NCT00113529|147506880|SUPERIORITY_OR_OTHER|||||||0.473||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.473
73980745|NCT00113529|147506880|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.286
73980746|NCT00113529|147506880|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.277
73980747|NCT00113529|147506880|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.956
73980748|NCT00113529|147506880|SUPERIORITY_OR_OTHER|||||||0.278||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.278
73980749|NCT00113529|147506881|SUPERIORITY_OR_OTHER|||||||0.275||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.275
73980750|NCT00113529|147506881|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.227
73980751|NCT00113529|147506881|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.029
73953320|NCT02059161|147440558|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.04|
73953321|NCT01852955|147440581|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.01
73953322|NCT01852955|147440582|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.04
73980752|NCT00113529|147506881|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||1.000
73980753|NCT00113529|147506881|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||1.000
73980754|NCT00113529|147506882|SUPERIORITY_OR_OTHER|||||||0.435||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.435
73980755|NCT00113529|147506882|SUPERIORITY_OR_OTHER|||||||0.722||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.722
73980756|NCT00113529|147506882|SUPERIORITY_OR_OTHER|||||||0.645||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.645
73953323|NCT01852955|147440583|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.36
73953324|NCT02013687|147440636|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)|||||||<0.001
73953325|NCT02013687|147440636|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)|||||||<0.001
73980757|NCT00113529|147506882|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.140
73980758|NCT00113529|147506882|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.046
73980759|NCT00113529|147506883|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
73980760|NCT00113529|147506883|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.854
73980761|NCT00113529|147506883|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.230
73980762|NCT00113529|147506883|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.067
73980763|NCT00113529|147506883|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.164
73980764|NCT00113529|147506883|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
73980765|NCT00113529|147506884|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
73980766|NCT00113529|147506884|SUPERIORITY_OR_OTHER|||||||0.462||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.462
73980767|NCT00113529|147506884|SUPERIORITY_OR_OTHER|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.423
73980768|NCT00113529|147506884|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.510
73980769|NCT00113529|147506884|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.608
73953326|NCT02013687|147440637|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
73953327|NCT02013687|147440637|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
73953328|NCT02013687|147440638|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
73953329|NCT02013687|147440638|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
73953330|NCT01272011|147440639|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Two-way RMANOVA Student-Newman-Keuls|||Daily acute and cumulative Pre vs Post comparisons||||<0.001
73953331|NCT01272011|147440640|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of AF vs. Resistance||||<0.05
73953332|NCT01272011|147440640|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of of Pressure vs. Resistance||||<0.05
73953333|NCT01657032|147440647|NON_INFERIORITY_OR_EQUIVALENCE|The differences between the study groups were considered significant when the P value was \<0.05.||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
73980770|NCT00113529|147506884|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
73980771|NCT00113529|147506885|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.910
73980772|NCT00113529|147506885|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.020
73980773|NCT00113529|147506885|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
73980774|NCT00113529|147506885|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.509
73980775|NCT00113529|147506885|SUPERIORITY_OR_OTHER|||||||0.883||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.883
73980776|NCT00113529|147506885|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.582
74033217|NCT01441440|147619177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64||||0.014|TWO_SIDED|95.0|0.54|4.74||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||4.74|0.54|0.014
73873324|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
73873325|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873326|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
73873327|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
73980777|NCT00113529|147506886|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.428
73980778|NCT00113529|147506886|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.075
73980779|NCT00113529|147506886|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
73980780|NCT00113529|147506886|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.019
73980781|NCT00113529|147506886|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.124
73980782|NCT00113529|147506886|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.055
73980783|NCT00113529|147506887|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
73980784|NCT00113529|147506887|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.854
73980785|NCT00113529|147506887|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.230
73980786|NCT00113529|147506887|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.067
73980787|NCT00113529|147506887|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.164
73980788|NCT00113529|147506887|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
73980789|NCT00113529|147506888|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
73980790|NCT00113529|147506888|SUPERIORITY_OR_OTHER|||||||0.462||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.462
73980791|NCT00113529|147506888|SUPERIORITY_OR_OTHER|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.423
73980792|NCT00113529|147506888|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.510
73980793|NCT00113529|147506888|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.608
73980794|NCT00113529|147506888|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
73980795|NCT00113529|147506889|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.910
73980796|NCT00113529|147506889|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.020
73980797|NCT00113529|147506889|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
73980798|NCT00113529|147506889|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.509
73980799|NCT00113529|147506889|SUPERIORITY_OR_OTHER|||||||0.883||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.883
73980800|NCT00113529|147506889|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.582
73980801|NCT00113529|147506890|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.428
73980802|NCT00113529|147506890|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.075
73980803|NCT00113529|147506890|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
73980804|NCT00113529|147506890|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.019
73980805|NCT00113529|147506890|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.124
73980806|NCT00113529|147506890|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.055
73980807|NCT02791308|147506915|EQUIVALENCE|Proportion of Subjects with Treatment Success at Visit 4/Day 15|Other|0.407|||||TWO_SIDED|90.0|-15.57|3.53||||||Percentage of Subjects with Treatment Success at Visit 4/Day 15||3.53|-15.57|
73980808|NCT00795639|147506924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0||||0.0104|TWO_SIDED|95.0|3.0|26.0||Significance test performed using non-parametric analysis of covariance controlling for Baseline 6MWD and PAH etiology and PAH not secondary to a connective tissue disease (other).|ANCOVA||Missing value at Week 12 assigned as zero if the subject had a predefined clinical worsening event, otherwise, missing value at Week 12 imputed with the last non-missing 6MWD based on LOCF.|||26|3|0.0104
73980809|NCT00795639|147506925|SUPERIORITY_OR_OTHER|||||||0.2908|TWO_SIDED|||||Significance tests of WHO Functional Class performed using the Cochran-Mantel-Haenszel (CMH) test, stratified by Baseline 6MWD (less than 310 meters and greater than or equal to 310 meters) and PAH Etiology (Connective Tissue Disease and others).|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores, and the p-value corresponding to ANCOVA (row mean scores) statistics were used.||Week 12||||0.2908
73980810|NCT00674765|147506929|SUPERIORITY_OR_OTHER|||||||0.388|||||||t-test, 2 sided|t=.87||||||.388
74033218|NCT01441440|147619178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26||||0.025|TWO_SIDED|95.0|0.03|0.49||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||0.49|0.03|0.025
73953334|NCT03633903|147440658|SUPERIORITY||Mean Difference (Final Values)|1.04|||<|0.05|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~This applies to the change from row 1 to row 3 (e.g., baseline pre TSST-C versus follow-up timepoint pre TSST-C)"|Mixed Models Analysis|||||||<.05
73953335|NCT03633903|147440658|SUPERIORITY||Mean Difference (Final Values)|0.77|||<|0.05|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~This is for the difference from row 1 to row 2 (baseline pre versus baseline post TSST-C)"|Mixed Models Analysis|||||||<.05
73953336|NCT03633903|147440658|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.4|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~Comparing row 1 and row 4 (baseline pre TSST-C versus follow-up post TSST-C)."|Mixed Models Analysis|||||||0.40
73953337|NCT03633903|147440659|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.39|TWO_SIDED||||||Mixed Models Analysis|||Comparing group differences (CRP biomarker) in mindfulness versus control at baseline versus follow-up timepoints.||||.39
73953338|NCT03633903|147440659|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.95|TWO_SIDED||||||Mixed Models Analysis|||Comparing group differences (IL-6 biomarker) in mindfulness versus control at baseline versus follow-up timepoints.||||.95
73980811|NCT01930188|147506973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-1.06|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.91|||Mixed Models Analysis|Post-baseline responses analysed with mixed model for repeated measurements-treatment \& country (fixed) \& baseline (covariate) all nested within visit||||-0.91|-1.21|<0.0001
73980812|NCT01930188|147506973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 0.5 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.62|||Mixed Models Analysis|Analysis done with mixed model for repeated measurements (treatment \& country as fixed factors \& baseline value as covariate) all nested within visit||||-0.62|-1.21|<0.0001
73980813|NCT00696241|147506982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.75|||<|0.001||95.0|-13.17|-8.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-8.34|-13.17|<0.001
73980814|NCT00696241|147506982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.08|||<|0.001|TWO_SIDED|95.0|-14.48|-9.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.67|-14.48|<0.001
73980815|NCT00696241|147506982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.21|||<|0.001|TWO_SIDED|95.0|-15.62|-10.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-10.81|-15.62|<0.001
74033219|NCT01441440|147619178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.032|TWO_SIDED|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||0.48|0.02|0.032
73953339|NCT03633903|147440660|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.08|TWO_SIDED|||||the calculated p value.|Mixed Models Analysis|||Comparing group differences (symptoms of anxiety/depression) in mindfulness versus control at baseline versus follow-up timepoints.||||.08
73953340|NCT01925170|147440683|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of the two groups for all densities, significant difference p ≤ 0.05.||||<0.001
73953341|NCT01925170|147440683|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Comparison of two groups for all densities; significant difference p ≤ 0.05.||||0.004
73953342|NCT01925170|147440684|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
73953343|NCT01925170|147440684|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.0001
73953344|NCT01925170|147440685|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||< 0.001
73953345|NCT01925170|147440685|SUPERIORITY_OR_OTHER|||||||0.004|||||||McNemar|||Significant difference p ≤ 0.05||||0.004
73953346|NCT01925170|147440686|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||< 0.001
73953347|NCT01925170|147440686|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
73953348|NCT01925170|147440687|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
73953349|NCT01925170|147440687|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
73953350|NCT02300311|147440705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.849|STANDARD_ERROR_OF_MEAN|0.306|<|0.0001|TWO_SIDED|95.0|-2.454|-1.244||The model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream - placebo).|"PID8 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 8 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, 4, 6 and 8 hours."||-1.244|-2.454|<0.0001
73953351|NCT02300311|147440706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.341|STANDARD_ERROR_OF_MEAN|0.248|<|0.0001|TWO_SIDED|95.0|-1.832|-0.851||The statistical model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream - placebo)|"PID4 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 4 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, and 4 hours."||-0.851|-1.832|<0.0001
74033220|NCT01441440|147619179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18||||0.004|TWO_SIDED|95.0|0.39|1.97||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||1.97|0.39|0.004
73873328|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.3|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.30
74033221|NCT01441440|147619179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06||||0.008|TWO_SIDED|95.0|0.28|1.85||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||1.85|0.28|0.008
74033222|NCT01441440|147619180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.004|TWO_SIDED|95.0|0.48|2.53||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||2.53|0.48|0.004
74033223|NCT01441440|147619180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.137|TWO_SIDED|95.0|-0.25|1.79||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||1.79|-0.25|0.137
74033224|NCT01441440|147619181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.073|TWO_SIDED|95.0|-0.02|0.45||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||0.45|-0.02|0.073
73873329|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873330|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
73873331|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.45
73873332|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
73873333|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73873334|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
74033225|NCT01441440|147619181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.034|TWO_SIDED|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||0.48|0.02|0.034
74033226|NCT01345123|147619193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0019994|STANDARD_ERROR_OF_MEAN|0.0400918||0.9602|TWO_SIDED|95.0|-0.0765899|0.080588716|||ANCOVA|Covariates: age, gender, Charlson Comorbidity Index, prior year total medical costs pmpm||||.080588716|-.07658990|0.9602
74033227|NCT01345123|147619193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013717|STANDARD_ERROR_OF_MEAN|0.04018791||0.7329|TWO_SIDED|95.0|-0.0924947|0.06506063|||ANCOVA|||||0.06506063|-0.0924947|0.7329
74033228|NCT01345123|147619194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.805||||0.0511||95.0|0.647|1.001|||Regression, Logistic|Covariates: Age, Gender, Charlson Comorbidity index, calculated risk of knee replacement, hip replacement, herniated disc surgery (score 1-99)||||1.001|0.647|0.0511
74033229|NCT01345123|147619197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31257||||0.0106|TWO_SIDED|95.0|0.06895|0.55618|||ANOVA|||||0.55618|0.06895|0.0106
74033230|NCT01345123|147619197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15982||||0.0106|TWO_SIDED|95.0|-0.06477|0.38441|||ANOVA|||||0.38441|-0.06477|0.0106
74033231|NCT01345123|147619200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009122|STANDARD_ERROR_OF_MEAN|0.0467091||0.8454|TWO_SIDED|95.0|-0.1008434|0.08259938|||ANCOVA|||||0.08259938|-0.1008434|0.8454
74033232|NCT01345123|147619200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0183548|STANDARD_ERROR_OF_MEAN|0.04690321||0.6956|TWO_SIDED|95.0|-0.1102961|0.07358642|||ANCOVA|||||0.07358642|-0.1102961|0.6956
74033233|NCT01725152|147619202|SUPERIORITY|||||||0.4475|||||||Linear mixed-effect|||Null hypothesis of no treatment difference in CGI-I will be assessed using a linear mixed-effects model for repeated measures, accounting for treatment (ganaxolone versus placebo) and period at a significant level of 0.05. A sample size of 30 participants in each arm/group was planned in the study will have 90% power to detect a modest effect size of 0.6 at level 0.05 in CGI-I. With a possible dropout rate of 15%, the power for testing the effect size becomes 84%.||||0.4475
74033234|NCT01111539|147619216|SUPERIORITY||Treatment Difference|-1.0|||=|0.644|TWO_SIDED|95.0|-5.2|3.3|||ANCOVA|||The statistical analyses was performed by fitting an analysis of covariance (ANCOVA) model to the change from baseline data (Week 8 Visit) for the MADRS Total Score at the Week 14 visit (LOCF). The model included baseline MADRS Total Score as a covariate and treatment as the main effect.||3.3|-5.2|=0.644
74033235|NCT01111539|147619216|SUPERIORITY||Treatment Difference|-3.7|||=|0.08|TWO_SIDED|95.0|-7.8|0.4|||ANCOVA|||The statistical analyses will be performed by fitting an ANCOVA model to the change from baseline data (Week 8 Visit) for the MADRS Total Score at the Week 14 visit (LOCF). The model will include baseline MADRS Total Score as a covariate and treatment as the main effect.||0.4|-7.8|=0.080
74033236|NCT01111539|147619217|SUPERIORITY||Treatment Difference|-0.3|||=|0.366|TWO_SIDED|95.0|-0.8|0.3|||Cochran-Mantel-Haenszel|||||0.3|-0.8|=0.366
73980816|NCT00696241|147506982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.687|TWO_SIDED|95.0|-1.55|2.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||2.35|-1.55|0.687
73980817|NCT00696241|147506982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.352|TWO_SIDED|95.0|-2.87|1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||1.02|-2.87|0.352
73980818|NCT00696241|147506982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06||||0.038|TWO_SIDED|95.0|-4.0|-0.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-0.12|-4.00|0.038
73980819|NCT00696241|147506983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.23|||<|0.001|TWO_SIDED|95.0|-15.45|-9.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.00|-15.45|<0.001
73980820|NCT00696241|147506983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.42|||<|0.001|TWO_SIDED|95.0|-15.64|-9.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.20|-15.64|<0.001
73980821|NCT00696241|147506983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.53|||<|0.001|TWO_SIDED|95.0|-18.74|-12.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-12.31|-18.74|<0.001
73980822|NCT00696241|147506983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.662|TWO_SIDED|95.0|-2.05|3.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||3.22|-2.05|0.662
73980823|NCT00696241|147506983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.768|TWO_SIDED|95.0|-2.24|3.03||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||3.03|-2.24|0.768
73980824|NCT00696241|147506983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.043|TWO_SIDED|95.0|-5.34|-0.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-0.09|-5.34|0.043
73980825|NCT00696241|147506984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.78|||<|0.001|TWO_SIDED|95.0|-8.34|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-8.34|<0.001
73980826|NCT00696241|147506984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.68|||<|0.001|TWO_SIDED|95.0|-9.24|-6.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.13|-9.24|<0.001
73980827|NCT00696241|147506984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||<|0.001|TWO_SIDED|95.0|-9.47|-6.36||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.36|-9.47|<0.001
73980828|NCT00696241|147506984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.679|TWO_SIDED|95.0|-0.99|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.52|-0.99|0.679
73980829|NCT00696241|147506984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.319|TWO_SIDED|95.0|-1.89|0.62||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.62|-1.89|0.319
73980830|NCT00696241|147506984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.172|TWO_SIDED|95.0|-2.13|0.38||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.38|-2.13|0.172
73980831|NCT00696241|147506985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.02|||<|0.001|TWO_SIDED|95.0|-8.83|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-8.83|<0.001
73980832|NCT00696241|147506985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.07|||<|0.001|TWO_SIDED|95.0|-8.87|-5.27||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.27|-8.87|<0.001
73980833|NCT00696241|147506985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.62|||<|0.001|TWO_SIDED|95.0|-10.42|-6.82||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.82|-10.42|<0.001
73980834|NCT00696241|147506985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.908|TWO_SIDED|95.0|-1.39|1.56||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.56|-1.39|0.908
73980835|NCT00696241|147506985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.956|TWO_SIDED|95.0|-1.43|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.52|-1.43|0.956
73980836|NCT00696241|147506985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.044|TWO_SIDED|95.0|-2.98|-0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.04|-2.98|0.044
73980837|NCT00696241|147506986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.03|||<|0.001|TWO_SIDED|95.0|-13.59|-8.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.48|-13.59|<0.001
73980838|NCT00696241|147506986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|||<|0.001|TWO_SIDED|95.0|-14.75|-9.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.65|-14.75|<0.001
73980839|NCT00696241|147506986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.41|||<|0.001|TWO_SIDED|95.0|-15.97|-10.86||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.86|-15.97|<0.001
73980840|NCT00696241|147506986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.879|TWO_SIDED|95.0|-1.9|2.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.22|-1.90|0.879
73980841|NCT00696241|147506986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.334|TWO_SIDED|95.0|-3.07|1.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.04|-3.07|0.334
73980842|NCT00696241|147506986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.034|TWO_SIDED|95.0|-4.28|-0.16||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.16|-4.28|0.034
73980843|NCT00696241|147506987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.12|||<|0.001|TWO_SIDED|95.0|-8.79|-5.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.45|-8.79|<0.001
73980844|NCT00696241|147506987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.84|||<|0.001|TWO_SIDED|95.0|-9.51|-6.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.18|-9.51|<0.001
74033237|NCT01111539|147619217|SUPERIORITY||Treatment Difference|-0.4|||=|0.138|TWO_SIDED|95.0|-0.9|0.1|||Cochran-Mantel-Haenszel|||||0.1|-0.9|=0.138
74033238|NCT01111539|147619218|SUPERIORITY||Treatment Difference|0.0|||=|0.995|TWO_SIDED|95.0|-1.2|1.2|||ANCOVA|||||1.2|-1.2|=0.995
74033239|NCT01111539|147619218|SUPERIORITY||Treatment Difference|-0.9|||=|0.118|TWO_SIDED|95.0|-2.1|0.2|||ANCOVA|||||0.2|-2.1|=0.118
74033240|NCT02808312|147619219|OTHER|Two-sided 90% Confidence Intervals (CIs) were calculated for the ratios of geometric least-squares means (GLSMs) of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7869|||||TWO_SIDED|90.0|1.2885|2.4781||||||An analysis of variance (ANOVA) model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||2.4781|1.2885|
73873335|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
73980845|NCT00696241|147506987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.28|||<|0.001|TWO_SIDED|95.0|-9.94|-6.61||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.61|-9.94|<0.001
73980846|NCT00696241|147506987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.877|TWO_SIDED|95.0|-1.24|1.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.45|-1.24|0.877
73980847|NCT00696241|147506987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.369|TWO_SIDED|95.0|-1.96|0.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.73|-1.96|0.369
73980848|NCT00696241|147506987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.126|TWO_SIDED|95.0|-2.39|0.3||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.30|-2.39|0.126
74033241|NCT02808312|147619219|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.4868|||||TWO_SIDED|90.0|1.6735|3.6954||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||3.6954|1.6735|
74033242|NCT02808312|147619219|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|6.324|||||TWO_SIDED|90.0|4.3675|9.1569||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||9.1569|4.3675|
74033243|NCT02808312|147619220|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7628|||||TWO_SIDED|90.0|1.275|2.4374||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||2.4374|1.2750|
73873336|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
74033244|NCT02808312|147619220|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.4559|||||TWO_SIDED|90.0|1.6531|3.6486||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||3.6486|1.6531|
74033245|NCT02808312|147619220|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|6.2497|||||TWO_SIDED|90.0|4.2965|9.091||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||9.0910|4.2965|
73953352|NCT02300311|147440707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.958|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.712|-2.205|||ANCOVA|ANCOVA using the fixed, categorical effects of treatment and country as well as the continuous covariate of baseline PI.|Differences between the treatment group effects (Finalgon® cream - placebo)|The difference of average pain intensity from pre-dose baseline on the last individual treatment day was analysed using ANCOVA.||-2.205|-3.712|<0.0001
73953353|NCT02300311|147440708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.37|||<|0.0001|TWO_SIDED|95.0|5.342|24.199|||Regression, Logistic|Ordinal logistic regression models adjusting for the continuous covariate 'baseline PI' and the categorical variable 'country' was performed.|Odds ratio of (Finalgon® cream / placebo)|"For the analysis of the repeated multinomial efficacy endpoint 'patient assessment of efficacy' on the last individual treatment day, ordinal logistic regression models is used.~Only non-missing data is analysed in the statistical model."||24.199|5.342|<0.0001
73873337|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
73953354|NCT02531438|147440711|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-1.6|||||TWO_SIDED|95.0|-7.1|3.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||3.8|-7.1|
73953355|NCT02531438|147440712|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-2.4|7.4|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||7.4|-2.4|
73953356|NCT02531438|147440713|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-1.7|6.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||6.8|-1.7|
73953357|NCT00811187|147440729|SUPERIORITY|\[Not Specified\]|Mean Difference (Net)|-2.03|||<|0.001|TWO_SIDED||||||Regression, Linear||Treatment pain difference= Lidocaine (0.97) - Placebo (3.00).|A sample size calculation and power analysis was conducted using PS Power and Sample Size Calculations 2.1.30 (Vanderbilt University, Department of Biostatistics, Nashville, TN) to determine necessary sample size.||||<.001
73953358|NCT00994279|147440734|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|TWO_SIDED||||||Chi-squared|||Null hypothesis is that the two arms will not differ in retention at 14 weeks.||||.53
73953359|NCT00994279|147440735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis is that the two groups would not differ in fatigue at 10 weeks.||||.98
73953360|NCT01606189|147440736|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.58||||0.005|TWO_SIDED|95.0|-0.98|-0.18|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an analysis of variance (ANOVA). The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period||-0.18|-0.98|0.005
73980849|NCT00696241|147506988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.13|||<|0.001|TWO_SIDED|95.0|-12.79|-7.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.48|-12.79|<0.001
73873338|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73953361|NCT01606189|147440736|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.002|TWO_SIDED|95.0|-1.03|-0.24|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period||-0.24|-1.03|0.002
73953362|NCT01606189|147440737|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.2||||0.017|TWO_SIDED|95.0|-0.37|-0.04|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period||-0.04|-0.37|0.017
73953363|NCT01606189|147440737|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.49|-0.16|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period||-0.16|-0.49|<0.001
73953364|NCT01606189|147440738|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.55||||0.019|TWO_SIDED|95.0|0.09|1.01|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period||1.01|0.09|0.019
73980850|NCT00696241|147506988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.43|||<|0.001|TWO_SIDED|95.0|-14.07|-8.78||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.78|-14.07|<0.001
73873339|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
73873340|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
73873341|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
73873342|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
73873343|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73873344|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873345|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
73953365|NCT01606189|147440738|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.79||||0.001|TWO_SIDED|95.0|0.33|1.24|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period||1.24|0.33|0.001
73953366|NCT01606189|147440739|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.55||||0.146|TWO_SIDED|95.0|-3.64|0.55|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period||0.55|-3.64|0.146
73980851|NCT00696241|147506988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-15.03|-9.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.73|-15.03|<0.001
73953367|NCT01606189|147440739|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.2||||0.04|TWO_SIDED|95.0|-4.29|-0.1|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period||-0.10|-4.29|0.040
73953368|NCT01606189|147440740|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.28||||0.092|TWO_SIDED|95.0|-15.78|1.21|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period||1.21|-15.78|0.092
73953369|NCT01606189|147440740|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-8.99||||0.037|TWO_SIDED|95.0|-17.41|-0.57|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period||-0.57|-17.41|0.037
73980852|NCT00696241|147506988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.346|TWO_SIDED|95.0|-1.12|3.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.18|-1.12|0.346
74033246|NCT02808312|147619221|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.5703|||||TWO_SIDED|90.0|1.0723|2.2995||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||2.2995|1.0723|
73873346|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873347|NCT01128426|147289443|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73953370|NCT01606189|147440741|SUPERIORITY_OR_OTHER_LEGACY||Mann-Whitney U statistic|1222.0||||0.328||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.||||0.328
73980853|NCT00696241|147506988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.811|TWO_SIDED|95.0|-2.4|1.88||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.88|-2.40|0.811
73980854|NCT00696241|147506988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.267|TWO_SIDED|95.0|-3.35|0.93||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.93|-3.35|0.267
73980855|NCT00696241|147506989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03|||<|0.001|TWO_SIDED|95.0|-7.84|-4.21||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.21|-7.84|<0.001
73873348|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
73873349|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873350|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873351|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873352|NCT01128426|147289443|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873353|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
74033247|NCT02808312|147619221|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7343|||||TWO_SIDED|90.0|1.2193|2.4667||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||2.4667|1.2193|
74033248|NCT02808312|147619221|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.5369|||||TWO_SIDED|90.0|1.7562|3.6648||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||3.6648|1.7562|
74033249|NCT02808312|147619232|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8722|||||TWO_SIDED|90.0|0.6827|1.1144||||||||1.1144|0.6827|
74033250|NCT02808312|147619232|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0731|||||TWO_SIDED|90.0|0.8295|1.3883||||||||1.3883|0.8295|
74033251|NCT02808312|147619232|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.1475|||||TWO_SIDED|90.0|0.8783|1.4992||||||||1.4992|0.8783|
73873354|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
73873355|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73873356|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
73873357|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.86
73873358|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873359|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
73873360|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
74033252|NCT02808312|147619233|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8188|||||TWO_SIDED|90.0|0.5837|1.1486||||||||1.1486|0.5837|
74033253|NCT02808312|147619233|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.1323|||||TWO_SIDED|90.0|0.8772|1.4615||||||||1.4615|0.8772|
74033254|NCT02808312|147619233|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.3563|||||TWO_SIDED|90.0|1.0468|1.7574||||||||1.7574|1.0468|
74033255|NCT02808312|147619234|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0658|||||TWO_SIDED|90.0|0.8275|1.3726||||||||1.3726|0.8275|
74033256|NCT02808312|147619234|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.2942|||||TWO_SIDED|90.0|0.9663|1.7334||||||||1.7334|0.9663|
74033257|NCT02808312|147619234|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8225|||||TWO_SIDED|90.0|0.5479|1.2347||||||||1.2347|0.5479|
74033258|NCT02808312|147619235|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0806|||||TWO_SIDED|90.0|0.791|1.4762||||||||1.4762|0.7910|
74033259|NCT02808312|147619235|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.3729|||||TWO_SIDED|90.0|0.9663|1.9506||||||||1.9506|0.9663|
74033260|NCT02808312|147619235|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.903|||||TWO_SIDED|90.0|0.6142|1.3275||||||||1.3275|0.6142|
74033261|NCT03100942|147619236|SUPERIORITY||Difference in Response Rates|15.6||||0.1597|TWO_SIDED|95.0|-6.3|37.6||P-values were obtained from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||37.6|-6.3|0.1597
74033262|NCT03100942|147619236|SUPERIORITY||Difference in Response Rates|16.6||||0.1694|TWO_SIDED|95.0|-5.1|38.3||P-values were obtained from CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||38.3|-5.1|0.1694
74033263|NCT03100942|147619236|SUPERIORITY||Difference in Response Rates|8.1||||0.3309|TWO_SIDED|95.0|-13.2|29.4||P-values were obtained from CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||29.4|-13.2|0.3309
74033264|NCT03100942|147619237|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.05||0.2066|TWO_SIDED|95.0|-0.7|3.4|||MMRM|||Least Squares (LS) Means, 95% confidence interval (CI), and P-values were obtained from Mixed Effects Model for Repeated Measures (MMRM) with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||3.4|-0.7|0.2066
73873361|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
73873362|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873363|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
73873364|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
73873365|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
73873366|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
73873367|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73953371|NCT01606189|147440741|SUPERIORITY_OR_OTHER_LEGACY||Mann-Whitney U statistic|1200.5||||0.56||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.||||0.560
73953372|NCT01606189|147440742|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.75||||0.181|TWO_SIDED|95.0|-4.32|0.83|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period||0.83|-4.32|0.181
73953373|NCT01606189|147440742|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.43||||0.739|TWO_SIDED|95.0|-2.12|2.98|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period||2.98|-2.12|0.739
73953374|NCT01606189|147440743|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.23||||0.015|TWO_SIDED|95.0|-4.01|-0.45|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period||-0.45|-4.01|0.015
73953375|NCT01606189|147440743|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.21||||0.178|TWO_SIDED|95.0|-2.97|0.56|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period||0.56|-2.97|0.178
73980856|NCT00696241|147506989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.94|||<|0.001|TWO_SIDED|95.0|-8.75|-5.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.13|-8.75|<0.001
73953376|NCT00162942|147440745|SUPERIORITY_OR_OTHER|||||||0.858|||||||Fisher Exact|||||||.858
73953377|NCT00162942|147440747|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||Student's t-test|||||||0.813
73953378|NCT00162942|147440748|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
73953379|NCT00162942|147440749|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Student's t-test|||||||0.670
73953380|NCT00162942|147440750|SUPERIORITY_OR_OTHER|||||||0.977||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.977
73980857|NCT00696241|147506989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|||<|0.001|TWO_SIDED|95.0|-8.65|-5.03||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.03|-8.65|<0.001
73873368|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
73873369|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
73873370|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
73873371|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||1|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||1.00
73873372|NCT01128426|147289444|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873373|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
73873374|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
73873375|NCT01128426|147289444|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873376|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
73953381|NCT00162942|147440751|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.670
73953382|NCT00162942|147440752|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.170
73873377|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
73980858|NCT00696241|147506989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.394|TWO_SIDED|95.0|-0.83|2.1||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.10|-0.83|0.394
73980859|NCT00696241|147506989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.712|TWO_SIDED|95.0|-1.74|1.19||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.19|-1.74|0.712
73980860|NCT00696241|147506989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.818|TWO_SIDED|95.0|-1.63|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.29|-1.63|0.818
73980861|NCT00696241|147506990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.35|||<|0.001|TWO_SIDED|95.0|-14.05|-8.64||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.64|-14.05|<0.001
73980862|NCT00696241|147506990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.001|TWO_SIDED|95.0|-15.38|-9.98||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.98|-15.38|<0.001
73980863|NCT00696241|147506990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.81|||<|0.001|TWO_SIDED|95.0|-16.51|-11.11||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.11|-16.51|<0.001
73980864|NCT00696241|147506990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.75|TWO_SIDED|95.0|-1.83|2.54||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.54|-1.83|0.750
73980865|NCT00696241|147506990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.378|TWO_SIDED|95.0|-3.16|1.2||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.20|-3.16|0.378
73980866|NCT00696241|147506990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.059|TWO_SIDED|95.0|-4.28|0.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.08|-4.28|0.059
74033265|NCT03100942|147619237|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.04||0.3998|TWO_SIDED|95.0|-2.9|1.2|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||1.2|-2.9|0.3998
74033266|NCT03100942|147619237|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.04||0.5113|TWO_SIDED|95.0|-1.4|2.7|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.7|-1.4|0.5113
74033267|NCT03100942|147619238|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.47||0.9446|TWO_SIDED|95.0|-0.9|1.0|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||1.0|-0.9|0.9446
73873378|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73980867|NCT00696241|147506991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.25|||<|0.001|TWO_SIDED|95.0|-9.02|-5.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.48|-9.02|<0.001
73980868|NCT00696241|147506991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.16|||<|0.001|TWO_SIDED|95.0|-9.92|-6.4||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.40|-9.92|<0.001
73980869|NCT00696241|147506991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||<|0.001|TWO_SIDED|95.0|-10.17|-6.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.65|-10.17|<0.001
73980870|NCT00696241|147506991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.845|TWO_SIDED|95.0|-1.29|1.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.57|-1.29|0.845
73980871|NCT00696241|147506991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.29|TWO_SIDED|95.0|-2.19|0.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.65|-2.19|0.290
74033268|NCT03100942|147619238|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.3977|TWO_SIDED|95.0|-1.3|0.5|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.5|-1.3|0.3977
74033269|NCT03100942|147619238|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.4966|TWO_SIDED|95.0|-1.2|0.6|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.6|-1.2|0.4966
74033270|NCT03100942|147619239|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.1||0.9564|TWO_SIDED|95.0|-2.2|2.1|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.1|-2.2|0.9564
74033271|NCT03100942|147619239|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.07||0.2788|TWO_SIDED|95.0|-3.3|0.9|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.9|-3.3|0.2788
74033272|NCT03100942|147619239|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.06||0.8047|TWO_SIDED|95.0|-1.8|2.3|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.3|-1.8|0.8047
73873379|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73873380|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873381|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
73873382|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
73873383|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873384|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
73873385|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
73953383|NCT00162942|147440753|SUPERIORITY_OR_OTHER|||||||0.0773||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0773
73953384|NCT00162942|147440754|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.261
73953385|NCT00162942|147440755|SUPERIORITY_OR_OTHER|||||||0.379||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.379
73953386|NCT00162942|147440756|SUPERIORITY_OR_OTHER|||||||0.441||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.441
73953387|NCT00162942|147440757|SUPERIORITY_OR_OTHER|||||||0.759||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.759
73953388|NCT00162942|147440758|SUPERIORITY_OR_OTHER|||||||0.222||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.222
73953389|NCT00162942|147440759|SUPERIORITY_OR_OTHER|||||||0.256||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.256
73953390|NCT00162942|147440760|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.870
73953391|NCT00162942|147440761|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.350
73953392|NCT00162942|147440762|SUPERIORITY_OR_OTHER|||||||0.0632||95.0|||||Fisher Exact|||||||0.0632
73953393|NCT00162942|147440762|SUPERIORITY_OR_OTHER|||||||0.0504||95.0|||||Fisher Exact (Mid-P-Value)|||||||0.0504
73873386|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
73873387|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873388|NCT01128426|147289444|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873389|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
73873390|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873391|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73873392|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873393|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873394|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
73953394|NCT00162942|147440763|SUPERIORITY_OR_OTHER|||||||0.8265||95.0|||||Fisher Exact|||||||0.8265
73953395|NCT00162942|147440764|SUPERIORITY_OR_OTHER|||||||0.0676||95.0|||||Fisher Exact|||||||0.0676
73953396|NCT00162942|147440764|SUPERIORITY_OR_OTHER|||||||0.0506||95.0|||||Fisher Exact (Mid-P-Value)|||||||0.0506
73953397|NCT00162942|147440765|SUPERIORITY_OR_OTHER|||||||0.8721||95.0|||||Fisher Exact|||||||0.8721
73953398|NCT00162942|147440766|SUPERIORITY_OR_OTHER|||||||0.0289||95.0|||||Fisher Exact|||||||0.0289
73953399|NCT00162942|147440767|SUPERIORITY_OR_OTHER|||||||0.8618||95.0|||||Fisher Exact|||||||0.8618
73953400|NCT00410384|147440772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.0167|TWO_SIDED|95.0|1.08|2.19||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: \<2g vs ≥2g per 24hr; Race: African/indig-American vs Other)||||2.19|1.08|0.0167
73953401|NCT00410384|147440772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0889|TWO_SIDED|95.0|0.95|1.94||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05)|Regression, Logistic|Adjusted for baseline stratification factors.||||1.94|0.95|0.0889
73953402|NCT00410384|147440773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.1323|TWO_SIDED|95.0|0.92|1.87|||Regression, Logistic|Analysis was adjusted for baseline stratification factors.||||1.87|0.92|0.1323
73953403|NCT00410384|147440773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.105|TWO_SIDED|95.0|0.94|1.91|||Regression, Logistic||Analysis was adjusted for baseline stratification factors.|||1.91|0.94|0.1050
73953404|NCT00410384|147440774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.0063|TWO_SIDED|95.0|1.15|2.32|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.32|1.15|0.0063
73953405|NCT00410384|147440774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.074|TWO_SIDED|95.0|0.97|1.96|||Regression, Logistic|Adjusted for baseline stratification factors.||||1.96|0.97|0.0740
74033273|NCT03100942|147619240|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.6782|TWO_SIDED|95.0|-1.1|0.7|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.7|-1.1|0.6782
74033274|NCT03100942|147619240|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.45||0.9171|TWO_SIDED|95.0|-0.8|0.9|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.9|-0.8|0.9171
74033275|NCT03100942|147619240|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.4641|TWO_SIDED|95.0|-1.2|0.5|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.5|-1.2|0.4641
74033276|NCT00372190|147619241|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73873395|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.65|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.65
73873396|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73953406|NCT00410384|147440775|SUPERIORITY_OR_OTHER|||||||0.7962|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.||||||0.7962
73953407|NCT00410384|147440775|SUPERIORITY_OR_OTHER|||||||0.9703|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.||||||0.9703
73953408|NCT00410384|147440776|SUPERIORITY_OR_OTHER|||||||0.6583|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.||||||0.6583
73953409|NCT00410384|147440776|SUPERIORITY_OR_OTHER|||||||0.3762|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.||||||0.3762
73953410|NCT00410384|147440777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.4253|TWO_SIDED|95.0|0.65|2.74|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.||||2.74|0.65|0.4253
73953411|NCT00410384|147440777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.2081|TWO_SIDED|95.0|0.78|3.13|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.||||3.13|0.78|0.2081
73953412|NCT01167023|147440781|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.26||||0.304||95.0||||Pain rate was analyzed using an analysis of covariance (ANCOVA) model, with baseline pain intensity, treatment group, and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||0.304
73953413|NCT01167023|147440783|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-24.051|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time\*treatment interaction as fixed effects, and participant as a random effect in the model was used.|Mixed Models Analysis||Least Squares Mean Difference is for 5 mg prasugrel minus placebo.|||||<0.001
73953414|NCT01167023|147440784|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56||||0.244||95.0||||Average pain intensity was analyzed using an analysis of covariance (ANCOVA) model, with baseline intensity, treatment group and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||0.244
74033277|NCT04184622|147619258|SUPERIORITY||Least Square (LS) Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-14.6|-12.5|||Mixed Models Analysis|||||-12.5|-14.6|<0.001
74033278|NCT04184622|147619258|SUPERIORITY||LS Mean Difference (Net)|-18.9|||<|0.001|TWO_SIDED|95.0|-20.0|-17.8|||Mixed Models Analysis|||||-17.8|-20.0|<0.001
74033279|NCT04184622|147619258|SUPERIORITY||LS Mean Difference (Net)|-20.1|||<|0.001|TWO_SIDED|95.0|-21.2|-19.0|||Mixed Models Analysis|||||-19.0|-21.2|<0.001
74033280|NCT04184622|147619259|SUPERIORITY||Odds Ratio (OR)|23.99|||<|0.001|TWO_SIDED|95.0|17.43|33.02|||Regression, Logistic|||||33.02|17.43|<0.001
74033281|NCT04184622|147619259|SUPERIORITY||Odds Ratio (OR)|73.63|||<|0.001|TWO_SIDED|95.0|46.98|115.39|||Regression, Logistic|||||115.39|46.98|<0.001
74033282|NCT04184622|147619259|SUPERIORITY||Odds Ratio (OR)|75.48|||<|0.001|TWO_SIDED|95.0|47.86|119.03|||Regression, Logistic|||||119.03|47.86|<0.001
74033283|NCT04184622|147619260|SUPERIORITY||LS Mean Difference (Net)|-10.7|||<|0.001|TWO_SIDED|95.0|-11.2|-10.1|||Mixed Models Analysis|||||-10.1|-11.2|<0.001
74033284|NCT04184622|147619261|SUPERIORITY||Odds Ratio (OR)|19.03|||<|0.001|TWO_SIDED|95.0|14.15|25.6|||Regression, Logistic|||||25.60|14.15|<0.001
74033285|NCT04184622|147619261|SUPERIORITY||Odds Ratio (OR)|44.17|||<|0.001|TWO_SIDED|95.0|31.75|61.45|||Regression, Logistic|||||61.45|31.75|<.001
74033286|NCT04184622|147619261|SUPERIORITY||Odds Ratio (OR)|65.64|||<|0.001|TWO_SIDED|95.0|45.94|93.77|||Regression, Logistic|||||93.77|45.94|<.001
74033287|NCT04184622|147619262|SUPERIORITY||Odds Ratio (OR)|17.08|||<|0.001|TWO_SIDED|95.0|11.83|24.66|||Regression, Logistic|||||24.66|11.83|<0.001
74033288|NCT04184622|147619262|SUPERIORITY||Odds Ratio (OR)|51.84|||<|0.001|TWO_SIDED|95.0|35.42|75.88|||Regression, Logistic|||||75.88|35.42|<0.001
74033289|NCT04184622|147619262|SUPERIORITY||Odds Ratio (OR)|66.63|||<|0.001|TWO_SIDED|95.0|45.23|98.16|||Regression, Logistic|||||98.16|45.23|<0.001
74033290|NCT04184622|147619263|SUPERIORITY||Odds Ratio (OR)|36.93|||<|0.001|TWO_SIDED|95.0|18.37|74.22|||Regression, Logistic|||||74.22|18.37|<0.001
74033291|NCT04184622|147619263|SUPERIORITY||Odds Ratio (OR)|109.45|||<|0.001|TWO_SIDED|95.0|54.5|219.81|||Regression, Logistic|||||219.81|54.50|<0.001
74033292|NCT04184622|147619263|SUPERIORITY||Odds Ratio (OR)|150.59|||<|0.001|TWO_SIDED|95.0|74.85|302.97|||Regression, Logistic|||||302.97|74.85|<0.001
74033293|NCT04184622|147619264|SUPERIORITY||LS Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-12.3|-10.0|||Mixed Models Analysis|||||-10.0|-12.3|<0.001
74033294|NCT04184622|147619264|SUPERIORITY||LS Mean Difference (Net)|-16.0|||<|0.001|TWO_SIDED|95.0|-17.2|-14.9|||Mixed Models Analysis|||||-14.9|-17.2|<0.001
74033295|NCT04184622|147619264|SUPERIORITY||LS Mean Difference (Net)|-16.5|||<|0.001|TWO_SIDED|95.0|-17.7|-15.4|||Mixed Models Analysis|||||-15.4|-17.7|<0.001
74033296|NCT04184622|147619265|SUPERIORITY||LS Mean Difference (Net)|2.3|||<|0.001|TWO_SIDED|95.0|1.6|2.9|||ANCOVA|||||2.9|1.6|<0.001
74033297|NCT04184622|147619266|SUPERIORITY||Estimate Difference|-22.7|||<|0.001|TWO_SIDED|95.0|-25.6|-19.8|||Mixed Models Analysis|||||-19.8|-25.6|<0.001
73953415|NCT01167023|147440785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-128.3|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time and time\*treatment interaction as fixed effects, and participant as a random effect in the model.|Mixed Models Analysis||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||<0.001
73953416|NCT01253200|147440788|NON_INFERIORITY_OR_EQUIVALENCE|The Primary Safety Endpoint was evaluated using a one-sided, non-inferiority test for two binomial proportions at an alpha-level of 0.05. A 95% confidence interval based upon a score test of the difference of proportion of subjects in the Investigational and Control Groups free from a procedure-related complication seven days post-procedure was constructed. The upper bound of the confidence interval was compared to 10%.|Risk Difference (RD)|4.6|||||ONE_SIDED|95.0||9.78||||||Note that analysis of the primary outcome was conducted for Randomized subjects only as prespecified in the study protocol. This is consistent analysis publicly available in the Summary of Safety and Effectiveness Data (SSED).||9.78||
73953417|NCT02049437|147440792|SUPERIORITY||Risk Ratio (RR)|4.43||||0.07|TWO_SIDED|95.0|0.9|21.83|||Mixed Models Analysis|||||21.83|0.90|0.07
73953418|NCT02049437|147440793|SUPERIORITY||Mean Difference (Final Values)|-2036.8|||<|0.001|TWO_SIDED|95.0|-3490.32|-900.62|||Wilcoxon (Mann-Whitney)|||||-900.62|-3490.32|<0.001
73953419|NCT02049437|147440794|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.77|TWO_SIDED|95.0|-0.79|0.65|||Wilcoxon (Mann-Whitney)|||||0.65|-0.79|0.77
73953420|NCT04529538|147440803|OTHER||GMT Ratio|0.68|||||TWO_SIDED|95.0|0.252|1.838|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of Type 1 neutralizing antibody GMT at Day 29||1.838|0.252|
73980872|NCT00696241|147506991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.161|TWO_SIDED|95.0|-2.44|0.41||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.41|-2.44|0.161
74033298|NCT04184622|147619267|SUPERIORITY||Estimate Difference|-4.91|||<|0.001|TWO_SIDED|95.0|-6.4|-3.41|||Mixed Models Analysis|||||-3.41|-6.40|<0.001
73873397|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
73953421|NCT04529538|147440804|OTHER||GMT Ratio|1.26|||||TWO_SIDED|95.0|0.232|6.833|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 1 neutralizing antibody GMT at Day 29||6.833|0.232|
73953422|NCT04529538|147440804|OTHER||GMT Ratio|1.98|||||TWO_SIDED|95.0|0.603|6.528|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 1 neutralizing antibody GMT at Day 57||6.528|0.603|
73953423|NCT04529538|147440805|OTHER||GMT Ratio|1.56|||||TWO_SIDED|95.0|0.639|3.828|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 29||3.828|0.639|
73953424|NCT04529538|147440806|OTHER||GMT Ratio|1.79|||||TWO_SIDED|95.0|0.772|4.163|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 29||4.163|0.772|
73953425|NCT04529538|147440806|OTHER||GMT Ratio|2.51|||||TWO_SIDED|95.0|0.994|6.34|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 57||6.340|0.994|
73953426|NCT04529538|147440807|OTHER||Rate Difference|-4.0|||>|0.999|TWO_SIDED|95.0|-27.67|22.72|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-Group Seroconversion Rate (4-fold rise) in Neutralizing Antibody Titers||22.72|-27.67|>0.999
73953427|NCT04529538|147440808|OTHER||Rate Difference|-2.8|||>|0.999|TWO_SIDED|95.0|-20.47|20.86|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.||20.86|-20.47|>0.999
73953428|NCT04529538|147440808|OTHER||Rate Difference|8.3||||0.263|TWO_SIDED|95.0|-5.71|30.57|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.||30.57|-5.71|0.263
73953429|NCT04529538|147440809|OTHER||Rate Difference|14.3||||0.224|TWO_SIDED|95.0|-8.3|40.45|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after vaccination||40.45|-8.30|0.224
73953430|NCT04529538|147440810|OTHER||Rate Difference|9.8||||0.275|TWO_SIDED|95.0|-7.29|35.19|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.||35.19|-7.29|0.275
73953431|NCT04529538|147440810|OTHER||Rate Difference|17.9||||0.1|TWO_SIDED|95.0|-1.27|44.93|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.||44.93|-1.27|0.100
73873398|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
73953432|NCT00235495|147440821|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.84|1.1||The generalized linear model with log link function is tested at the one-sided alpha level of 0.025.|Regression, Logistic|Adjustment is made for baseline NIHSS and Thrombolysis stratum.|Adjusted risk ratio greater than 1 indicates greater risk of good outcome in the Albumin treatment group, while adjusted risk ratio less than 1 indicates greater risk of good outcome in the Saline treatment group.|Test of null hypothesis (equal proportions of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin and Saline treatment arms) versus alternative hypothesis (greater proportion of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin treatment arm).||1.10|0.84|
73953433|NCT00235495|147440822|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|||||TWO_SIDED|99.0|0.8|1.09|||Regression, Logistic|||||1.09|0.80|
73953434|NCT00235495|147440823|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.66|1.49|||Regression, Logistic|||||1.49|0.66|
73953435|NCT00235495|147440824|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88|||||TWO_SIDED|99.0|0.71|1.1|||Regression, Logistic|||||1.10|0.71|
73953436|NCT00235495|147440825|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03|||||TWO_SIDED|99.0|0.82|1.28|||Regression, Logistic|||||1.28|0.82|
73953437|NCT00235495|147440826|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.85|1.13|||Regression, Logistic|||||1.13|0.85|
73953438|NCT00235495|147440827|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98|||||TWO_SIDED|99.0|0.87|1.11|||Regression, Logistic|||||1.11|0.87|
73953439|NCT00235495|147440828|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.95|||||TWO_SIDED|99.0|0.83|1.1|||Regression, Logistic|||||1.10|0.83|
73953440|NCT00235495|147440829|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.84|1.17|||Regression, Logistic|||||1.17|0.84|
74033299|NCT04184622|147619268|SUPERIORITY||Estimate Difference|7.65|||<|0.001|TWO_SIDED|95.0|5.85|9.49|||Mixed Models Analysis|||||9.49|5.85|<0.001
73953441|NCT00235495|147440830|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|||||TWO_SIDED|99.0|0.84|1.02|||Regression, Logistic|||||1.02|0.84|
73953442|NCT00235495|147440831|SUPERIORITY_OR_OTHER_LEGACY||Rank Sum|73098.0||||0.913||95.0|||||Wilcoxon rank sum test, normal approx|||||||0.913
73953443|NCT00235495|147440832|SUPERIORITY_OR_OTHER_LEGACY||Rank Sum|44853.5||||0.923||95.0|||||Wilcoxon rank sum test, normal approx|||||||0.923
73953444|NCT00235495|147440833|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.79|1.76|||Regression, Logistic|||||1.76|0.79|
73953445|NCT00235495|147440834|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.47|2.15|||Regression, Logistic|||||2.15|0.47|
73953446|NCT00235495|147440835|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.39|3.41|||Regression, Logistic|||||3.41|0.39|
73953447|NCT00235495|147440836|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.69|||||TWO_SIDED|95.0|0.98|2.94|||Regression, Logistic|||||2.94|0.98|
73953448|NCT00235495|147440837|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|10.8|||||TWO_SIDED|95.0|4.37|26.72|||Regression, Logistic|||||26.72|4.37|
73953449|NCT00235495|147440838|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.58|||||TWO_SIDED|95.0|1.09|6.12|||Regression, Logistic|||||6.12|1.09|
73873399|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
73953450|NCT00235495|147440839|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.42|||||TWO_SIDED|95.0|1.02|5.78|||Regression, Logistic|||||5.78|1.02|
73953451|NCT00235495|147440840|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.68|2.01|||Regression, Logistic|||||2.01|0.68|
73953452|NCT00235495|147440841|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.68|1.61|||Regression, Logistic|||||1.61|0.68|
73953453|NCT00235495|147440842|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.74|1.63|||Regression, Logistic|||||1.63|0.74|
73953454|NCT05567952|147440843|SUPERIORITY||Least square (LS) mean difference|-0.705|||=|0.0004|TWO_SIDED|95.0|-1.093|-0.316|||MMRM|||Mixed model for repeated measures (MMRM) included fixed effects of treatment, geographic region, baseline SARS-CoV-2 RNA level, visit, and treatment-by-visit interaction; an unstructured (co) variance structure was used.||-0.316|-1.093|= 0.0004
73953455|NCT05567952|147440844|SUPERIORITY||Hazard Ratio (HR)|1.235|||=|0.0697|TWO_SIDED|95.0|0.983|1.551|||COX proportional hazard ratio|||Analysis was based on Cox proportional hazard (PH) model which included treatment, geographic region, baseline SARS-CoV-2 RNA level (\< 4 log10 copies/mL or \>= 4 log10 copies/mL) and time since the last vaccination (less than or equal to \[\<=6\] months, \> 6 months or unvaccinated) as appropriate.||1.551|0.983|= 0.0697
73953456|NCT05567952|147440845|SUPERIORITY||Hazard Ratio (HR)|1.084|||=|0.5202|TWO_SIDED|95.0|0.848|1.385|||COX proportional hazard ratio|||Analysis was based on Cox proportional hazard (PH) model which included treatment, geographic region, baseline SARS-CoV-2 RNA level (\< 4 log10 copies/mL or \>= 4 log10 copies/mL) and time since the last vaccination (\<=6 months, \> 6 months or unvaccinated) as appropriate.||1.385|0.848|= 0.5202
73953457|NCT05160025|147440851|SUPERIORITY||||||<|0.001||||||"rmANOVA \< 0.001~post hoc paired t-tests or nonparametric equivalent with correction (x3) indicated the following: self-competition \> feedback (p \< 0.001) other-competition \> feedback (p \< 0.001) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||<0.001
73980873|NCT00696241|147506992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.94|||<|0.001|TWO_SIDED|95.0|-13.88|-8.0||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.00|-13.88|<0.001
73980874|NCT00696241|147506992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.18|||<|0.001|TWO_SIDED|95.0|-14.11|-8.24||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.24|-14.11|<0.001
73873400|NCT01128426|147289444|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73953458|NCT05160025|147440854|SUPERIORITY|||||||0.111||||||"rmANOVA p = 0.111~post hoc paired t-tests not performed"|ANOVA|||||||0.111
73953459|NCT05160025|147440857|SUPERIORITY||||||<|0.001||||||"rmANOVA \< 0.001~post hoc paired t-tests or nonparametric equivalent corrected (x3) indicated the following: self-competition \> feedback (p = 0.003) other-competition \> feedback (p = 0.007) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||<0.001
73953460|NCT05160025|147440860|SUPERIORITY||||||>|0.05||||||"rmANOVA p \> 0.05 with a partial eta squared effect size = 0.073~post hoc paired t-tests not performed"|ANOVA|||||||> 0.05
73953461|NCT05160025|147440865|SUPERIORITY|||||||0.004||||||"rmANOVA = 0.004~post hoc paired t-tests or nonparametric equivalent corrected (x3) indicated the following: self-competition \> feedback (p = 0.007) other-competition \> feedback (p = 0.002) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||0.004
73953462|NCT05160025|147440873|SUPERIORITY||||||>|0.05||||||ranking compared to expected value for each condition and the p-value was adjusted for 3 comparisons for each condition: self-competition (p \> 0.05) other-competition (p \> 0.05) feedback (p \> 0.05)|Chi-squared|||||||> 0.05
73953463|NCT05160025|147440874|SUPERIORITY||||||>|0.05||||||ranking compared to expected value for each condition and the p-value was adjusted for 3 comparisons for each condition: self-competition (p \> 0.05) other-competition (p \> 0.05) feedback (p \> 0.05)|Chi-squared|||||||> 0.05
73980875|NCT00696241|147506992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.21|||<|0.001|TWO_SIDED|95.0|-15.15|-9.28||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.28|-15.15|<0.001
73980876|NCT00696241|147506992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.385|TWO_SIDED|95.0|-3.43|1.33||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.33|-3.43|0.385
73873401|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
73873402|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873403|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73873404|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73953464|NCT05516342|147440879|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73953465|NCT05516342|147440880|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73953466|NCT05516342|147440881|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73953467|NCT05516342|147440882|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73953468|NCT05516342|147440883|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73980877|NCT00696241|147506992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.285|TWO_SIDED|95.0|-3.66|1.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.08|-3.66|0.285
73873405|NCT01128426|147289444|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873406|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
73873407|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
73873408|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73873409|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
73873410|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873411|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873412|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
73873413|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
73873414|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73873415|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
73953469|NCT05516342|147440884|SUPERIORITY|||||||0.89|||||||ANOVA|||||||0.89
73953470|NCT05516342|147440885|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
73953471|NCT05516342|147440886|SUPERIORITY|||||||0.19|||||||ANOVA|||||||0.19
73873416|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
73873417|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73953472|NCT05516342|147440887|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
73953473|NCT01852162|147440889|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An analysis of covariance (ANCOVA) method with a general linear model, using the corresponding baseline PD value as a covariate, was used to evaluate the comparisons between dabigatran and placebo at 7 days.|ANCOVA|||Assuming a 20% relative difference in TRAP induced MPA between dabigatran and placebo with a common standard deviation of 10%, 13 patients with available data needed to be randomized to obtain a 95% power and 2-sided alpha=0.05.||||<0.05
73953474|NCT01866475|147440894|NON_INFERIORITY|This study is designed to test the hypothesis that the IO device has no greater than a 4 percent infection rate. Equivalently, we define success as having at least a 96 percent infection free 48-hour placement.|||||||||||||||||The historical data for the device suggests an infection rate of 0.6 percent per 48 hours or a success rate of 99.4 percent. The formal objective in the design is to reject the one-sided null hypothesis that the success rate is no higher than 96 percent. The analysis will use the exact binomial test and will tolerate a Type I Error rate of 0.05 or less. If we assume a 99.4 percent success rate, the study will have 84 percent power with a sample size of 117 to reject the null hypothesis. If the null hypothesis is rejected, we conclude that the infection rate is less than 4 percent.|||
73953475|NCT03660943|147440898|SUPERIORITY||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|1.192||0.0833|TWO_SIDED|95.0|-4.42|0.27|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.27|-4.42|0.0833
73953476|NCT03660943|147440899|SUPERIORITY|The number of NPRS subjects differed from the WOMAC outcomes because of differences in missing data.|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.251||0.0935|TWO_SIDED|95.0|-0.91|0.07|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.07|-0.91|0.0935
73980878|NCT00696241|147506992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.054|TWO_SIDED|95.0|-4.7|0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.04|-4.70|0.054
74033300|NCT04184622|147619269|SUPERIORITY||LS Mean Difference (Net)|-6.8|||<|0.001|TWO_SIDED|95.0|-7.9|-5.7|||Mixed Models Analysis|||||-5.7|-7.9|<0.001
73873418|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873419|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73873420|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
73873421|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.8|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.80
73953477|NCT03660943|147440900|SUPERIORITY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.506||0.0163|TWO_SIDED|95.0|-2.22|-0.23|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||-0.23|-2.22|0.0163
73980879|NCT00696241|147506993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|||<|0.001|TWO_SIDED|95.0|-8.93|-4.75||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.75|-8.93|<0.001
73980880|NCT00696241|147506993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|||<|0.001|TWO_SIDED|95.0|-8.89|-4.72||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.72|-8.89|<0.001
74033301|NCT04184622|147619270|SUPERIORITY||Estimate Difference|-41.2|||<|0.001|TWO_SIDED|95.0|-44.9|-37.3|||Mixed Models Analysis|||||-37.3|-44.9|<0.001
73873422|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
73873423|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
73953478|NCT03660943|147440901|SUPERIORITY||Mean Difference (Final Values)|-7.99|STANDARD_ERROR_OF_MEAN|4.076||0.0509|TWO_SIDED|95.0|-16.01|0.03|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.03|-16.01|0.0509
73953479|NCT05310084|147440917|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate-administration group) was greater than 0.67.|GMR|0.83|||||TWO_SIDED|95.0|0.77|0.89|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of concentrations (coadmin group-separate admin group), corresponding CIs based on analysis of log transformed assay results using a linear regression model.|||0.89|0.77|
73953480|NCT05310084|147440918|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67|Geometric Mean Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.04|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|B/Austria||1.04|0.77|
73953481|NCT05310084|147440918|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|B/Phuket||1.13|0.89|
73953482|NCT05310084|147440918|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|H1N1 A/Victoria||1.09|0.83|
73953483|NCT05310084|147440918|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|0.96|||||TWO_SIDED|95.0|0.85|1.09|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|H3N2 A/Darwin||1.09|0.85|
73873424|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
73953484|NCT03251144|147440934|OTHER||Mean Difference (Final Values)|20.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73953485|NCT02892409|147440940|EQUIVALENCE|LS Mean Ratio (TAK-438/Lansoprazole), 95 percent (%) confidence interval (CI) of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|Least Square (LS) Mean Ratio|105.1|||||TWO_SIDED|95.0|66.051|167.183||||||||167.183|66.051|
73953486|NCT02892409|147440941|EQUIVALENCE|LS Mean Ratio (TAK-438/Lansoprazole), 95% CI of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|LS Mean Ratio|93.6|||||TWO_SIDED|95.0|67.137|130.569||||||||130.569|67.137|
73953487|NCT02331940|147440943|SUPERIORITY_OR_OTHER|||||||0.88||||||p\<0.05 was considered statistically significant|t-test, 1 sided|||||||0.88
73980881|NCT00696241|147506993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.55|||<|0.001|TWO_SIDED|95.0|-9.64|-5.47||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.47|-9.64|<0.001
73873425|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
73980882|NCT00696241|147506993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.642|TWO_SIDED|95.0|-2.09|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.29|-2.09|0.642
74033302|NCT04184622|147619271|SUPERIORITY||LS Mean Difference (Net)|-13.2|||<|0.0001|TWO_SIDED|95.0|-15.3|-11.1|||Mixed Models Analysis|||||-11.1|-15.3|<.0001
74033303|NCT04184622|147619271|SUPERIORITY||LS Mean Difference (Net)|-17.7|||<|0.0001|TWO_SIDED|95.0|-19.8|-15.7|||Mixed Models Analysis|||||-15.7|-19.8|<.0001
73873426|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
73953488|NCT04365413|147440951|OTHER||Median Difference (Final Values)|0.069|||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
73953489|NCT04365413|147440952|OTHER||Median Difference (Final Values)|0.042|||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
73953490|NCT02037061|147440954|OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
73953491|NCT03019458|147440957|SUPERIORITY|||||||0.084||||||The p value was not adjusted for multiple comparisons but rather it is the priori threshold for statistical significance at p\<0.05.|Mixed Models Analysis|We adjusted for baseline Eating Assessment Tool-10 (EAT-10), MGH-Swallowing Screening Test (MGH-SST), and the Burkes-Fahn-Marsden Dysonia Scale (BFM).||||||0.084
73953492|NCT01561079|147440961|SUPERIORITY_OR_OTHER|||||||0.001||||||The p values were not adjusted for multiplicity The a priori threshold = .05|Hierarchical Linear Modeling|The p-value was calculated||||||0.001
73953493|NCT01561079|147440962|SUPERIORITY_OR_OTHER||||||<|0.002|||||||Hierarchical Linear Modeling|||||||<.002
73953494|NCT01561079|147440963|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Hierarchical Linear Modeling|||||||0.0001
73953495|NCT01561079|147440964|SUPERIORITY_OR_OTHER|||||||0.008|||||||Hierarchical Linear Modeling|The reported p-value was calculated||||||.008
73953496|NCT01561079|147440965|SUPERIORITY_OR_OTHER|||||||0.002|||||||Hierarchical Linear Modeling|||||||.002
73953497|NCT00367237|147440986|SUPERIORITY_OR_OTHER||Difference in percentages of respondents|19.61||||0.021||95.0|3.27|35.95||Comparison of treatments (IFX + MTX versus MTX)|Chi-squared||Difference in percentages of respondents is (percentage of respondents in IFX+MTX group minus percentage of respondents in MTX group)|||35.95|3.27|0.0210
73953498|NCT00367237|147440986|SUPERIORITY_OR_OTHER||Proportion of Responders|0.863||||||95.0||||||||||||
73953499|NCT00367237|147440986|SUPERIORITY_OR_OTHER||Proportion of Responders|0.667||||||95.0||||||||||||
73980883|NCT00696241|147506993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.672|TWO_SIDED|95.0|-2.05|1.32||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.32|-2.05|0.672
73980884|NCT00696241|147506993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.196|TWO_SIDED|95.0|-2.8|0.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.57|-2.80|0.196
73980885|NCT00696241|147506994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48|||<|0.001|TWO_SIDED|95.0|2.71|7.39||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.39|2.71|<0.001
74033304|NCT04184622|147619271|SUPERIORITY||LS Mean Difference (Net)|-20.7|||<|0.0001|TWO_SIDED|95.0|-22.8|-18.6|||Mixed Models Analysis|||||-18.6|-22.8|<.0001
74033305|NCT04184622|147619272|SUPERIORITY||Hazard Ratio (HR)|0.06|||<|0.0001|TWO_SIDED|95.0|0.03|0.13|||Regression, Cox|||||0.13|0.03|<0.0001
73873427|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
73953500|NCT01207934|147441000|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||ANOVA for reapeated measures was used to compare the three groups.|ANOVA|||The null hypothesis was that there would be no change in glucose disposal between the three groups (placebo, low dose leptin, and high dose leptin). Power calculations were done showing that 6 subjects in each arm was enough to detect a 35% between group difference in glucose disposal at the 0.05 level with 80% power.||||>0.05
73953501|NCT01207934|147441001|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|T-tests compared pre and post-treatment values.||The null hypothesis is that treatment would not effect plasma leptin levels.||||<0.01
73953502|NCT01207934|147441001|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||a priori threshold for significance was p = 0.05.|t-test, 2 sided|||null hypothesis was that plasma leptin levels would be equal after treatment in the placebo and high-dose leptin groups.||||<0.01
73953503|NCT01276535|147441003|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.||||<0.01
73953504|NCT01276535|147441004|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.||||<0.01
73953505|NCT04004208|147441030|NON_INFERIORITY|Non inferiority margin is 5%. Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|0.034|||||TWO_SIDED|90.0|-0.08|0.162||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.162|-0.08|
73980886|NCT00696241|147506994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97|||<|0.001|TWO_SIDED|95.0|3.01|8.2||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||8.20|3.01|<0.001
73980887|NCT00696241|147506994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.53|||<|0.001|TWO_SIDED|95.0|3.95|10.79||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||10.79|3.95|<0.001
74033306|NCT04184622|147619273|SUPERIORITY||Hazard Ratio (HR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.07|0.21|||Regression, Cox|||||0.21|0.07|<0.0001
74033307|NCT04184622|147619274|SUPERIORITY||LS Mean Difference (Net)|-5.1|||<|0.001|TWO_SIDED|95.0|-5.5|-4.6|||Mixed Models Analysis|||||-4.6|-5.5|<0.001
74033308|NCT04184622|147619274|SUPERIORITY||LS Mean Difference (Net)|-7.2|||<|0.001|TWO_SIDED|95.0|-7.7|-6.8|||Mixed Models Analysis|||||-6.8|-7.7|<0.001
74033309|NCT04184622|147619274|SUPERIORITY||LS Mean Difference (Net)|-7.7|||<|0.001|TWO_SIDED|95.0|-8.2|-7.3|||Mixed Models Analysis|||||-7.3|-8.2|<0.001
73953506|NCT04004208|147441031|OTHER|Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|-0.023|||||TWO_SIDED|90.0|-0.11|0.046||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.046|-0.11|
73953507|NCT04004208|147441032|OTHER|Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|0.096|||||TWO_SIDED|90.0|0.019|0.175||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.175|0.019|
73953508|NCT01341080|147441045|OTHER||Cohen's d|0.15||||0.05|TWO_SIDED|95.0|-4.01|4.61|||Repeated measures analysis or variance|||Efficacy was measured as a change on the Berg Balance Scale (BBS) from baseline to the end of study after 8 weeks on drug. The BBS has a scale range of 0-56, with 56 indicating normal balance. To evaluate efficacy, repeated measures analysis of variance was run on BBS scores. The scale score was the dependent measure, time point (baseline or end of study) was the repeat measure, and treatment group (varenicline or sugar pill) was the independent measure. Significance was defined as alpha \<0.05.||4.61|-4.01|0.05
73953509|NCT01341080|147441046|OTHER||Cohen's d|0.16||||0.05|TWO_SIDED|95.0|-1.39|1.53|||Repeated measures analysis or variance|||Change in cognitive functioning was measured in part with the Frontal Assessment Battery (FAB) from Baseline to 8 weeks on drug. Repeated analysis of variance was run on the FAB scores. Scale cores was the dependent measure, time point (Baseline or end of study) was the repeated measure, and treatment group (varenicline or sugar pill) was the independent measure. Significant was defined as \<0.05.||1.53|-1.39|0.05
73953510|NCT01341080|147441047|OTHER||Cohen's d|0.81||||0.05|TWO_SIDED|95.0|-0.4|1.4|||Repeated measures analysis or variance|||Change in cognitive functioning was measured in part with the Mini Mental State Exam (MMSE) from Baseline to 8 weeks on drug. Repeated analysis of variance was run on the MMSE scores. Scale score was the dependent measure, time point (Baseline or end of study) was the repeated measure, and treatment group (varenicline or sugar pill) was the independent measure. Significant was defined as \<0.05.||1.40|-0.40|0.05
73953511|NCT03248440|147441083|SUPERIORITY|||||||0.579|||||||2-sided Pearson's chi-square|||||||0.579
73953512|NCT03248440|147441084|SUPERIORITY|||||||0.082|||||||2-sided Pearson's chi-square|||||||0.082
73980888|NCT00696241|147506994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.173|TWO_SIDED|95.0|0.57|1.11||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.11|0.57|0.173
73980889|NCT00696241|147506994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.449|TWO_SIDED|95.0|0.63|1.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.23|0.63|0.449
74033310|NCT04184622|147619275|SUPERIORITY||LS Mean Difference (Net)|-0.33|||<|0.001|TWO_SIDED|95.0|-0.36|-0.3|||Mixed Models Analysis|||||-0.30|-0.36|<0.001
73873428|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73953513|NCT01052662|147441085|SUPERIORITY_OR_OTHER||Slope|-0.00935|STANDARD_ERROR_OF_MEAN|0.00356|=|0.00874|TWO_SIDED||||||Mixed Models Analysis||Z = -2.62209|We modeled the mean proportion of weekly opioid use using a mixed-effect linear regression approach to assess the treatment effect, the time effect and the interaction of time x treatment effect while adjusting for the baseline mean proportion of weekly opioid use with baseline COWS, Addiction Severity Index (ASI) psychiatric and legal composite scores as covariates.||||=0.00874
73953514|NCT01052662|147441086|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.87||||0.64|TWO_SIDED||||||Log Rank|||||||0.64
73953515|NCT01052662|147441087|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.4||||1.2|TWO_SIDED|||||These results are using survival curve estimates to first positive urine toxicology for any opioid. The last observation carried forward (LOCF) was used to perform our survival event analyses.|Log Rank|||||||1.2
73953516|NCT00087490|147441088|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the Food and Drug Administration (FDA) suggested boundary of delta= -0.10.|Percent Difference|4.2||||0.249|TWO_SIDED|95.0|-3.0|11.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95 percent (%) confidence interval (CI).||11.5|-3.0|0.249
73953517|NCT00087490|147441089|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|3.9||||0.168|TWO_SIDED|95.0|-1.7|9.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||9.5|-1.7|0.168
73953518|NCT00087490|147441090|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.1||||0.048|TWO_SIDED|95.0|0.1|14.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||14.2|0.1|0.048
73953519|NCT00087490|147441091|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|4.8||||0.09|TWO_SIDED|95.0|-0.7|10.3|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||10.3|-0.7|0.090
73980890|NCT00696241|147506994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.402|TWO_SIDED|95.0|0.83|1.62||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.62|0.83|0.402
74033311|NCT04184622|147619275|SUPERIORITY||LS Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.45|-0.38|||Mixed Models Analysis|||||-0.38|-0.45|<0.001
74089511|NCT01172821|147731714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.029||0.0019|TWO_SIDED|95.0|0.033|0.145|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.145|0.033|0.0019
74089512|NCT01172821|147731715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.759|STANDARD_ERROR_OF_MEAN|4.963|<|0.0001|TWO_SIDED|95.0|19.025|38.494|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||38.494|19.025|<0.0001
73980891|NCT00696241|147506995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86|||<|0.001|TWO_SIDED|95.0|1.82|4.48||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.48|1.82|<0.001
73980892|NCT00696241|147506995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39|||<|0.001|TWO_SIDED|95.0|2.15|5.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.35|2.15|<0.001
73980893|NCT00696241|147506995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81|||<|0.001|TWO_SIDED|95.0|2.41|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.02|2.41|<0.001
73980894|NCT00696241|147506995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.177|TWO_SIDED|95.0|0.52|1.13||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.13|0.52|0.177
73980895|NCT00696241|147506995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.628|TWO_SIDED|95.0|0.61|1.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.35|0.61|0.628
73980896|NCT00696241|147506995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.928|TWO_SIDED|95.0|0.68|1.52||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.52|0.68|0.928
73980897|NCT00696241|147506996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.001|TWO_SIDED|95.0|2.66|7.72||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.72|2.66|<0.001
73980898|NCT00696241|147506996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.04|||<|0.001|TWO_SIDED|95.0|2.96|8.58||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||8.58|2.96|<0.001
73980899|NCT00696241|147506996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.75|||<|0.001|TWO_SIDED|95.0|3.96|11.48||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||11.48|3.96|<0.001
73980900|NCT00696241|147506996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.217|TWO_SIDED|95.0|0.58|1.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.13|0.58|0.217
73980901|NCT00696241|147506996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.537|TWO_SIDED|95.0|0.64|1.26||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.26|0.64|0.537
73980902|NCT00696241|147506996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.276|TWO_SIDED|95.0|0.86|1.68||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.68|0.86|0.276
73980903|NCT02429115|147506997|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73980904|NCT02429115|147506998|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73980905|NCT02429115|147506999|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73980906|NCT00090519|147507003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.969|TWO_SIDED|95.0|-0.714|0.686|||ANOVA|||||0.686|-0.714|0.969
73980907|NCT00090519|147507004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09||||0.015|TWO_SIDED|95.0|0.21|1.97||P-value is for change from baseline.|ANCOVA|||||1.97|0.21|0.015
73980908|NCT00090519|147507005|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||P-value is for first occurrence of focal/grid photocoagulation yes versus no.|Chi-squared|||||||0.577
73873429|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873430|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873431|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73953520|NCT00087490|147441092|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|6.6||||0.127|TWO_SIDED|95.0|-1.9|15.0|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||15.0|-1.9|0.127
73953521|NCT00087490|147441093|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|16.6||||0|TWO_SIDED|95.0|9.0|24.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||24.2|9.0|0.000
73953522|NCT00087490|147441094|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.7||||0.051|TWO_SIDED|95.0|0.0|15.4|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||15.4|-0.0|0.051
73953523|NCT00087490|147441095|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|15.0||||0|TWO_SIDED|95.0|8.2|21.8|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||21.8|8.2|0.000
73953524|NCT00087490|147441098|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED|||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.||||0.022
73953525|NCT00087490|147441099|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.||||0.016
73953526|NCT00087490|147441100|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||t-test, 2 sided|||||||0.000
73873432|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73953527|NCT00087490|147441101|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||t-test, 2 sided|||||||0.000
73953528|NCT01700530|147441116|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73953529|NCT01253980|147441118|SUPERIORITY_OR_OTHER||Relative risk|0.6|||>|0.5|TWO_SIDED|95.0|0.11|3.37|||Fisher Exact|||||3.37|0.11|>0.50
73953530|NCT04883346|147441121|SUPERIORITY||Mean Difference (Final Values)|-3.2|STANDARD_DEVIATION|3.4|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 32 degrees of freedom (one participant did not have baseline DEXA data so could not be included.||||||<0.001
73953531|NCT04883346|147441122|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|1.5|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom.||||||<0.001
73953532|NCT04883346|147441123|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|0.1|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom||||||<0.001
73953533|NCT04883346|147441124|SUPERIORITY|Paired t-test.|Mean Difference (Final Values)|-4.4|STANDARD_DEVIATION|4.4|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom||||||<0.001
73953534|NCT03714022|147441138|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.998|||||TWO_SIDED|90.0|0.941|1.058|||||Cohort A vs Cohort B|||1.058|0.941|
73953535|NCT03714022|147441139|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.929|||||TWO_SIDED|90.0|0.884|0.976|||||Cohort A vs Cohort B|||0.976|0.884|
73953536|NCT03714022|147441141|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.936|||||TWO_SIDED|90.0|0.891|0.983|||||Cohort A vs Cohort B|||0.983|0.891|
73873433|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
73873434|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
73953537|NCT03714022|147441142|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.957|||||TWO_SIDED|90.0|0.915|1.001|||||Cohort A vs Cohort B|||1.001|0.915|
73953538|NCT04447820|147441189|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3084|||||||Mixed Model for repeated measures (MMRM)|||||||0.3084
73980909|NCT00090519|147507006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.041|TWO_SIDED|95.0|0.02|0.87||P-value is for change from baseline.|ANCOVA|||||0.87|0.02|0.041
73873435|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73953539|NCT04447820|147441189|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.593|||||||Mixed Model for repeated measures (MMRM)|||||||0.5930
73953540|NCT04447820|147441190|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.9788|||||||MMRM|||||||0.9788
73953541|NCT04447820|147441190|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.1314|||||||MMRM|||||||0.1314
73953542|NCT04447820|147441191|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.884|||||||MMRM analysis|||||||0.8840
73953543|NCT04447820|147441191|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.1202|||||||MMRM analysis|||||||0.1202
73953544|NCT04447820|147441192|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.9353|||||||MMRM|||||||0.9353
73953545|NCT04447820|147441192|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3099|||||||MMRM|||||||0.3099
73953546|NCT04447820|147441193|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.2098|||||||MMRM|||||||0.2098
73953547|NCT04447820|147441193|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3688|||||||MMRM|||||||0.3688
73953548|NCT04447820|147441194|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.5647|||||||MMRM|||||||0.5647
73953549|NCT04447820|147441194|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.217|||||||MMRM|||||||0.2170
73953550|NCT04447820|147441195|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.2562|||||||MMRM|||||||0.2562
73980910|NCT00090519|147507007|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||P-value is for progression of nonproliferative diabetic retinopathy (DR) by seven-field stereo fundus photography progression versus no progression.|Chi-squared|||||||0.475
73873436|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
74089513|NCT01172821|147731715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.178|STANDARD_ERROR_OF_MEAN|4.985|<|0.0001|TWO_SIDED|95.0|18.401|37.956|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||37.956|18.401|<0.0001
74089514|NCT01172821|147731716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.068||0.87|TWO_SIDED|95.0|-0.122|0.144|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.144|-0.122|0.8700
73873437|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73953551|NCT04447820|147441195|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.4268|||||||MMRM|||||||0.4268
73953552|NCT00615433|147441214|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||Improvements in PANSS ratings are estimated from 2 prior studies of lurasidone. Assuming lurasidone differs from placebo in change from baseline in PANSS by 6.8 and 10.0 for 40 and 120 mg, respectively, and assuming a standard deviation of 19.1, then n=120 subjects per group provides approximately 97% power (at α=0.05, two-sided) to reject the null hypothesis of no difference from placebo for at least 1 dose. This calculation uses Bonferroni's procedure for controlling pairwise differences.||||<0.05
73953553|NCT00615433|147441215|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
73953554|NCT01125774|147441234|SUPERIORITY_OR_OTHER||Difference in percent incidence|-1.2|||||TWO_SIDED|95.0|-4.4|2.1|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||2.1|-4.4|
73953555|NCT01125774|147441235|SUPERIORITY_OR_OTHER||Difference in percent incidence|-0.2|||||TWO_SIDED|95.0|-1.4|0.8|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||0.8|-1.4|
73953556|NCT01125774|147441236|SUPERIORITY_OR_OTHER||Difference in percent incidence|0.6|||||TWO_SIDED|95.0|-0.5|1.6|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||1.6|-0.5|
73953557|NCT01125774|147441238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.13|TWO_SIDED|95.0|-1.1|0.1||α=0.0499|Longitudinal data analysis (LDA)||Difference is Telcagepant 140 mg versus Placebo|This measure tests the primary hypothesis, that telcagepant 140 mg is superior to placebo as measured by mean monthly headache days in participants with MRM or PMM||0.1|-1.1|0.130
73953558|NCT01125774|147441239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.369|TWO_SIDED|95.0|-1.0|0.4||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||0.4|-1.0|0.369
73953559|NCT01125774|147441240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||-0.2|-0.5|<0.001
73953560|NCT01125774|147441241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||-0.2|-0.5|<0.001
73953561|NCT01125774|147441242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.393|TWO_SIDED|95.0|-0.4|0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||0.2|-0.4|0.393
74089515|NCT01172821|147731716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.068||0.9612|TWO_SIDED|95.0|-0.137|0.13|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.130|-0.137|0.9612
73873438|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73953562|NCT02337361|147441274|OTHER||||||||||||||||||Generalized estimating equations (GEE)(Diggle et al. 2002) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||
73953563|NCT02337361|147441274|OTHER||||||||||||||||||Generalized estimating equations tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation|||
73953564|NCT02337361|147441275|OTHER||Odds Ratio (OR)|0.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.01|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report weekly or more frequent drinking at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||<.01
73953565|NCT02337361|147441276|OTHER||Odds Ratio (OR)|0.23|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report drinking a maximum quantity of 5 or more drinks in a day at 6 month follow-up|||||<.05
73980911|NCT00090519|147507008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.211|TWO_SIDED|95.0|-0.87|3.92||P-value is for change from baseline.|ANCOVA|||||3.92|-0.87|0.211
73980912|NCT00090519|147507009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.22||||0.365|TWO_SIDED|95.0|-73.68|200.12||P-value is for change from baseline.|t-test, 2 sided|||||200.12|-73.68|0.365
73980913|NCT00090519|147507010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.009|TWO_SIDED|95.0|0.38|2.66||P-value is for change from baseline.|ANCOVA|||||2.66|0.38|0.009
73980914|NCT00090519|147507012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.081|TWO_SIDED|95.0|0.2|1.12||P-value is for occurrence of sustained moderate visual loss (SMVL) in a diabetic retinopathy (DR) study eye yes versus no.|Chi-squared|||||1.12|0.20|0.081
73980915|NCT01974102|147507013|SUPERIORITY||||||<|0.015|||||||t-test, 2 sided|||||||<0.015
73980916|NCT01974102|147507014|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
73980917|NCT01094106|147507073|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||In a previous non-randomised study at our institution, the mean oxycodone consumption in the control group was 60.7 mg (SD, 22.2 mg) during the first 48 h after caesarean section. At α = 0.05, 31 patients would be needed in each group to achieve a power of 90% for detecting a 30% reduction in the need for rescue opioids, which we considered a clinically meaningful effect. We decided to enrol 70 patients. The final study population was 67 patients.||||0.10
73980918|NCT01094106|147507074|SUPERIORITY|||||||0.08||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 0-6 h||||0.08
74033312|NCT04184622|147619275|SUPERIORITY||LS Mean Difference (Net)|-0.44|||<|0.001|TWO_SIDED|95.0|-0.48|-0.41|||Mixed Models Analysis|||||-0.41|-0.48|<0.001
73873439|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73953566|NCT02337361|147441277|OTHER||Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report any tobacco use at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||<.10
73873440|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
73953567|NCT02337361|147441278|OTHER||Odds Ratio (OR)|0.26|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report significant depression at 6 month follow-up|||||<.01
73980919|NCT01094106|147507074|SUPERIORITY|||||||0.86||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 6-12 h||||0.86
73980920|NCT01094106|147507074|SUPERIORITY|||||||0.66||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 12-24 h||||0.66
73980921|NCT01094106|147507074|SUPERIORITY|||||||0.79||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 24-36 h||||0.79
73980922|NCT01094106|147507074|SUPERIORITY|||||||0.2||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 36-48 h||||0.20
73980923|NCT01094106|147507074|SUPERIORITY|||||||0.36||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 0-6 h||||0.36
73980924|NCT01094106|147507074|SUPERIORITY|||||||0.43||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 6-12 h||||0.43
73980925|NCT01094106|147507074|SUPERIORITY|||||||0.68||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 12-24 h||||0.68
73980926|NCT01094106|147507074|SUPERIORITY|||||||0.37||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 24-36 h||||0.37
73980927|NCT01094106|147507074|SUPERIORITY|||||||0.06||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 36-48 h||||0.06
73980928|NCT01094106|147507075|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
73980929|NCT01294644|147507076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|1.52|4.43|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||4.43|1.52|<0.001
73980930|NCT01294644|147507076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.83|5.36|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||5.36|1.83|<0.001
73980931|NCT01294644|147507077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.71||||0.02|TWO_SIDED|95.0|1.48|92.67|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||92.67|1.48|0.020
74033313|NCT04184622|147619276|SUPERIORITY||LS Mean Difference (Net)|-8.59|||<|0.001|TWO_SIDED|95.0|-9.97|-7.2|||Mixed Models Analysis|||||-7.20|-9.97|<0.001
73953568|NCT02337361|147441279|OTHER||||||||||||||||||Generalized estimating equations (GEE) tested DrinkWise's effects on changes in depression over time controlling for demographic differences between study condition and study sites.|||
74033314|NCT04184622|147619276|SUPERIORITY||LS Mean Difference (Net)|-10.59|||<|0.001|TWO_SIDED|95.0|-11.98|-9.21|||Mixed Models Analysis|||||-9.21|-11.98|<0.001
74033315|NCT04184622|147619276|SUPERIORITY||LS Mean Difference (Net)|-11.42|||<|0.001|TWO_SIDED|95.0|-12.8|-10.3|||Mixed Models Analysis|||||-10.30|-12.80|<0.001
74033316|NCT04184622|147619277|SUPERIORITY||Estimate Difference|-6.06|||<|0.001|TWO_SIDED|95.0|-8.32|-3.75|||Mixed Models Analysis|||||-3.75|-8.32|<0.001
74033317|NCT04184622|147619278|SUPERIORITY||Estimate Difference|-23.3|||<|0.001|TWO_SIDED|95.0|-26.1|-20.4|||Mixed Models Analysis|||||-20.4|-26.1|<0.001
74089516|NCT01172821|147731717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.127|STANDARD_ERROR_OF_MEAN|0.059||0.0305|TWO_SIDED|95.0|-0.241|-0.012|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.012|-0.241|0.0305
74089517|NCT01172821|147731717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.059||0.1602|TWO_SIDED|95.0|-0.198|0.033|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.033|-0.198|0.1602
73980932|NCT01294644|147507077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.53||||0.021|TWO_SIDED|95.0|1.46|91.24|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||91.24|1.46|0.021
73980933|NCT01294644|147507078|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.37|||<|0.001|TWO_SIDED|95.0|3.06|9.44|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model.|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||9.44|3.06|<0.001
73980934|NCT01294644|147507078|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.62|||<|0.001|TWO_SIDED|95.0|2.65|8.04|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||8.04|2.65|<0.001
73980935|NCT01294644|147507079|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|||<|0.001|TWO_SIDED|95.0|-0.51|-0.19|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline CR-SMFRS values as covariate.||||-0.19|-0.51|<0.001
73980936|NCT01294644|147507079|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.56|-0.24|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.24|-0.56|<0.001
73980937|NCT01294644|147507080|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|||<|0.001|TWO_SIDED|95.0|0.97|1.75|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.75|0.97|<0.001
74089518|NCT01172821|147731718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4012|TWO_SIDED|95.0|0.81|1.74||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.74|0.81|0.4012
73980938|NCT01294644|147507080|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|||<|0.001|TWO_SIDED|95.0|0.87|1.65|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.65|0.87|<0.001
74033318|NCT04184622|147619279|SUPERIORITY||Estimate Difference|-11.3|||<|0.001|TWO_SIDED|95.0|-16.1|-6.2|||Mixed Models Analysis|||||-6.2|-16.1|<0.001
74033319|NCT04184622|147619280|SUPERIORITY||LS Mean Difference (Net)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.0|-3.5|||Mixed Models Analysis|||||-3.5|-5.0|<0.001
74033320|NCT04184622|147619281|SUPERIORITY||Odds Ratio (OR)|29.79|||<|0.0001|TWO_SIDED|95.0|17.73|50.05|||Regression, Logistic|||||50.05|17.73|<.0001
74033321|NCT04184622|147619281|SUPERIORITY||Odds Ratio (OR)|35.05|||<|0.0001|TWO_SIDED|95.0|20.63|59.53|||Regression, Logistic|||||59.53|20.63|<.0001
74033322|NCT04184622|147619281|SUPERIORITY||Odds Ratio (OR)|55.05|||<|0.0001|TWO_SIDED|95.0|29.61|102.34|||Regression, Logistic|||||102.34|29.61|<.0001
74033323|NCT04184622|147619282|SUPERIORITY||LS Mean Difference (Net)|7.7|||<|0.001|TWO_SIDED|95.0|5.6|9.8|||ANCOVA|||||9.8|5.6|<0.001
74033324|NCT04184622|147619282|SUPERIORITY||LS Mean Difference (Net)|10.7|||<|0.001|TWO_SIDED|95.0|8.6|12.8|||ANCOVA|||||12.8|8.6|<0.001
74033325|NCT04184622|147619282|SUPERIORITY||LS Mean Difference (Net)|11.7|||<|0.001|TWO_SIDED|95.0|9.6|13.8|||ANCOVA|||||13.8|9.6|<0.001
74033326|NCT01763905|147619304|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.06|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-43.73|-32.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-32.99|-43.73|<0.001
74033327|NCT01763905|147619304|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.55|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-42.16|-32.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-32.94|-42.16|<0.001
73953569|NCT02427646|147441282|OTHER|"A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (lme4 package using lmer function)."|||||<|0.05|||||||Linear mixed effects model|||||||<0.05
73953570|NCT02427646|147441283|OTHER|"A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (lme4 package using lmer function)."|||||<|0.05|||||||Linear mixed effects model|a log-transformation ofthe RMS datasets was applied for statistical analysis||||||<0.05
74033328|NCT01763905|147619305|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.3|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-77.9|-54.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-54.7|-77.9|<0.001
73953571|NCT01641861|147441284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.1|7.3||||||||7.3|0.1|
73980939|NCT01294644|147507081|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.09|TWO_SIDED|95.0|-1.72|0.13|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||0.13|-1.72|0.090
73980940|NCT01294644|147507081|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.97||||0.04|TWO_SIDED|95.0|-1.89|-0.05|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||-0.05|-1.89|0.040
73980941|NCT01294644|147507082|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Pearson's chi-square test|||||||0.009
73980942|NCT01294644|147507082|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Pearson's chi-square test|||||||0.001
73980943|NCT02548585|147507094|SUPERIORITY||||||<|0.0001|||||||ANCOVA|p-value was based on pairwise comparison using analysis of covariance (ANCOVA) adjusted by baseline value.||||||< 0.0001
73980944|NCT02548585|147507095|SUPERIORITY|||||||0.0008|||||||ANCOVA|p-value was based on pairwise comparison using ANCOVA adjusted by baseline value.||||||0.0008
73980945|NCT01782209|147507139|OTHER||Incidence|17.3|||||TWO_SIDED|95.0|13.4|21.8|||||95% Clopper-Pearson Confidence Interval|||21.8|13.4|
73980946|NCT02033174|147507148|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.05
73980947|NCT03242863|147507149|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73980948|NCT03242863|147507150|SUPERIORITY|||||||0.0015|||||||Mixed Models Analysis|||||||0.0015
73980949|NCT03242863|147507151|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73980950|NCT03242863|147507152|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73953572|NCT01641861|147441285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||||TWO_SIDED|95.0|0.9|12.8||||||||12.8|0.9|
73953573|NCT01641861|147441287|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
73953574|NCT01641861|147441288|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
73980951|NCT01898299|147507157|SUPERIORITY||Cohen's d effectsize|0.48||||0.036|TWO_SIDED||||||ANCOVA|Control for Chlopromazine equivalents||||||0.036
73980952|NCT00264576|147507165|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.7|1.04|||ANOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.04|0.70|
73980953|NCT00264576|147507165|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.57|||||TWO_SIDED|95.0|0.46|0.7|||ANOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.70|0.46|
74033329|NCT01763905|147619305|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.6|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-80.5|-60.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-60.7|-80.5|<0.001
74033330|NCT01763905|147619306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.7|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-82.0|-57.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-57.5|-82.0|<0.001
73953575|NCT00901485|147441299|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To test for non-inferiority, a sample size of 36 (18 patients completing both arms of the crossover) was calculated to provide 80% power to detect a 2.5% drop in the primary outcome, mean overnight oxygen saturation (SpO2), with a SD of 3% at a significance level of 0.05|Median Difference (Final Values)|0.4||||0.13|TWO_SIDED|95.0|-0.2|1.0||a priori threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||"We tested the hypothesis that iVAPS can ventilate a patient naive to NIV at least as effectively as standard PS.~Sleep and breathing parameters at the end of each treatment period were compared using Wilcoxon Signed Rank test. The median difference between treatments with 95% confidence intervals was then compared by related-samples Hodges-Lehman test"||1.0|-0.2|0.13
73953576|NCT00901485|147441300|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|PtcCO2 is compared as a secondary outcome resulting in CO2 elimination similar to that of standard PS ventilation (median difference (95% CI) of -0.04(- 0.03 to 0.4)kPa in mean overnight PtcCO2).|Median Difference (Final Values)|0.0||||0.54|TWO_SIDED|95.0|-0.3|0.4|||Wilcoxon (Mann-Whitney)|||Hypothesis: that we tested the hypothesis that iVAPS, with automated selection of ventilator settings, was non-inferior to standard pressure support (PS) ventilation, with settings determined by an experienced healthcare professional, for controlling nocturnal hypoventilation in patients naïve to NIV.||0.4|-0.3|0.54
73953577|NCT00901485|147441301|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.5|-0.5|0.94
73873441|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73953578|NCT00901485|147441302|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-1.0||||0.42|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-2|0.42
73953579|NCT00901485|147441303|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.0||||0.82||95.0|-8.0|4.0|||Wilcoxon (Mann-Whitney)|||||4|-8|0.82
73953580|NCT00901485|147441304|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|1.04||||0.0004|TWO_SIDED|95.0|0.27|1.44|||Wilcoxon (Mann-Whitney)|||||1.44|0.27|0.0004
73953581|NCT00901485|147441305|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Mean Difference (Net)|-0.2||||0.5|TWO_SIDED|95.0|-1.2|0.5|||Wilcoxon (Mann-Whitney)|||||0.5|-1.2|0.5
73953582|NCT00901485|147441306|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-2.2||||0.001|TWO_SIDED|95.0|-4.5|0.3|||Wilcoxon (Mann-Whitney)|||||0.3|-4.5|0.001
73953583|NCT00901485|147441307|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-10.0||||0.47|TWO_SIDED|95.0|-54.0|23.0|||Wilcoxon (Mann-Whitney)|||||23|-54|0.47
73953584|NCT00901485|147441308|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.3||||0.41|TWO_SIDED|95.0|-0.7|2.2|||Wilcoxon (Mann-Whitney)|||||2.2|-0.7|0.41
73953585|NCT00901485|147441309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|4.0||||0.36|TWO_SIDED|95.0|-5.0|12.0|||Wilcoxon (Mann-Whitney)|||||12|-5|0.36
73953586|NCT00901485|147441310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|2.0||||0.59|TWO_SIDED|95.0|-5.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-5|0.59
73953587|NCT00901485|147441311|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|2.0||||0.59|TWO_SIDED|95.0|-5.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-5|0.59
73953588|NCT00901485|147441312|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-1.0||||0.72|TWO_SIDED|95.0|-9.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|-9|0.72
73953589|NCT05305040|147441353|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.049||0.5603|TWO_SIDED|95.0|-0.09|0.1||1-sided p-value|ANCOVA|||||0.10|-0.09|0.5603
73953590|NCT01033643|147441358|OTHER||Accumulation or Geometric Mean Ratio|2.36|||||||||||||Accumulation ratio or geometric mean ratio (GMR) was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
73953591|NCT01033643|147441359|OTHER||Accumulation or Geometric Mean Ratio|1.62|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 13) divided by the first day of multiple dosing of MK-3614 (Day 4).|||||
73953592|NCT01033643|147441361|OTHER||Accumulation or Geometric Mean Ratio|1.9|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
73953593|NCT01033643|147441361|OTHER||Accumulation or Geometric Mean Ratio|1.63|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
73953594|NCT01033643|147441362|OTHER||Accumulation or Geometric Mean Ratio|1.91|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
73953595|NCT01033643|147441363|OTHER||Accumulation or Geometric Mean Ratio|1.38|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 13) divided by the first day of multiple dosing of MK-3614 (Day 4).|||||
73953596|NCT01033643|147441370|OTHER|Linear Model|Mean Difference from Placebo|-4.17|||||TWO_SIDED|90.0|-9.53|1.2||||||||1.20|-9.53|
73953597|NCT01033643|147441370|OTHER|Linear Model|Mean Difference from Placebo|4.78|||||TWO_SIDED|90.0|-1.41|10.97||||||||10.97|-1.41|
73953598|NCT01033643|147441370|OTHER|Linear Model|Mean Difference from Placebo|-3.47|||||TWO_SIDED|90.0|-8.37|1.42||||||||1.42|-8.37|
73953599|NCT01033643|147441370|OTHER|Linear Model|Mean Difference from Placebo|3.53|||||TWO_SIDED|90.0|-1.37|8.42||||||||8.42|-1.37|
73953600|NCT01033643|147441371|OTHER|Linear Model|Mean Difference from Placebo|0.23|||||TWO_SIDED|90.0|-6.91|7.36||||||||7.36|-6.91|
73953601|NCT01033643|147441371|OTHER|Linear Model|Mean Difference from Placebo|-1.66|||||TWO_SIDED|90.0|-8.79|5.47||||||||5.47|-8.79|
73953602|NCT01033643|147441371|OTHER|Linear Model|Mean Difference from Placebo|2.11|||||TWO_SIDED|90.0|-5.02|9.25||||||||9.25|-5.02|
73873442|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873443|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73873444|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73873445|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873446|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73873447|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.8|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.80
73873448|NCT01128426|147289445|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873449|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73953603|NCT01033643|147441371|OTHER|Linear Model|Mean Difference from Placebo|-1.23|||||TWO_SIDED|90.0|-9.41|6.94||||||||6.94|-9.41|
73953604|NCT01033643|147441372|OTHER|Linear Model|Mean Difference from Placebo|-0.75|||||TWO_SIDED|90.0|-9.29|7.79||||||||7.79|-9.29|
73953605|NCT01033643|147441372|OTHER|Linear Model|Mean Difference from Placebo|-3.73|||||TWO_SIDED|90.0|-14.32|6.86||||||||6.86|-14.32|
73953606|NCT01033643|147441372|OTHER|Linear Model|Mean Difference from Placebo|0.66|||||TWO_SIDED|90.0|-7.88|9.2||||||||9.20|-7.88|
73953607|NCT01033643|147441372|OTHER|Linear Model|Mean Difference from Placebo|-9.92|||||TWO_SIDED|90.0|-19.54|-0.3||||||||-0.30|-19.54|
73980954|NCT00264576|147507165|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.95|1.36|||ANOVA|||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.36|0.95|
73953608|NCT01033643|147441373|OTHER|Linear Model|Mean Difference from Placebo|-1.02|||||TWO_SIDED|90.0|-9.36|7.32||||||||7.32|-9.36|
74089519|NCT01172821|147731718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||1.1727|TWO_SIDED|95.0|0.67|1.42||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.42|0.67|1.1727
73873450|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873451|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
73873452|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73873453|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
73873454|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
73873455|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73873456|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
73873457|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
73953609|NCT01033643|147441373|OTHER|Linear Model|Mean Difference from Placebo|-2.12|||||TWO_SIDED|90.0|-12.47|8.22||||||||8.22|-12.47|
73953610|NCT01033643|147441373|OTHER|Linear Model|Mean Difference from Placebo|-0.53|||||TWO_SIDED|90.0|-8.87|7.81||||||||7.81|-8.87|
73953611|NCT01033643|147441373|OTHER|Linear Model|Mean Difference from Placebo|-10.44|||||TWO_SIDED|90.0|-19.83|-1.04||||||||-1.04|-19.83|
73953612|NCT01033643|147441374|OTHER|Linear Model|Mean Difference from Placebo|-1.73|||||TWO_SIDED|90.0|-6.5|3.04||||||||3.04|-6.50|
73953613|NCT01033643|147441374|OTHER|Linear Model|Mean Difference from Placebo|-4.23|||||TWO_SIDED|90.0|-9.0|0.54||||||||0.54|-9.00|
73953614|NCT01033643|147441374|OTHER|Linear Model|Mean Difference from Placebo|-1.05|||||TWO_SIDED|90.0|-5.82|3.72||||||||3.72|-5.82|
73953615|NCT01033643|147441374|OTHER|Linear Model|Mean Difference from Placebo|-2.0|||||TWO_SIDED|90.0|-3.46|7.46||||||||7.46|-3.46|
73953616|NCT01033643|147441375|OTHER|Linear Model|Mean Difference from Placebo|-3.87|||||TWO_SIDED|90.0|-9.37|1.64||||||||1.64|-9.37|
73953617|NCT01033643|147441375|OTHER|Linear Model|Mean Difference from Placebo|-7.2|||||TWO_SIDED|90.0|-14.03|-0.37||||||||-0.37|-14.03|
73953618|NCT01033643|147441375|OTHER|Linear Model|Mean Difference from Placebo|-1.33|||||TWO_SIDED|90.0|-6.83|4.18||||||||4.18|-6.83|
73953619|NCT01033643|147441375|OTHER|Linear Model|Mean Difference from Placebo|-2.24|||||TWO_SIDED|90.0|-8.45|3.96||||||||3.96|-8.45|
73953620|NCT01033643|147441376|OTHER|Linear Model|Mean Difference from Placebo|-2.74|||||TWO_SIDED|90.0|-7.92|2.43||||||||2.43|-7.92|
73953621|NCT01033643|147441376|OTHER|Linear Model|Mean Difference from Placebo|-6.67|||||TWO_SIDED|90.0|-13.09|-0.25||||||||-0.25|-13.09|
73873458|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.84|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.84
73980955|NCT00264576|147507165|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|0.92|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.12|0.76|
73980956|NCT00264576|147507165|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.5|0.75|||ANOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.75|0.50|
73980957|NCT00264576|147507165|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|1.31|||||TWO_SIDED|95.0|1.09|1.57|||ANOVA|||"The following hypotheses were tested for B strain as measured by cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.57|1.09|
73980958|NCT00264576|147507171|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.7|1.03|||ANCOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.03|0.70|
73980959|NCT00264576|147507171|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.63|||||TWO_SIDED|95.0|0.52|0.76|||ANCOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.76|0.52|
73980960|NCT00264576|147507171|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.16|||||TWO_SIDED|95.0|0.98|1.38|||ANCOVA|||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.38|0.98|
73980961|NCT00264576|147507171|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.92|||||TWO_SIDED|95.0|0.76|1.12||To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|ANCOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.12|0.76|
73980962|NCT00264576|147507171|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.57|0.83|||ANCOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.83|0.57|
73980963|NCT00264576|147507171|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.33|||||TWO_SIDED|95.0|1.13|1.58|||ANCOVA|||"The following hypotheses were tested for B strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.58|1.13|
73873459|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.64|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.64
73873460|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
74089520|NCT01172821|147731719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.613|STANDARD_ERROR_OF_MEAN|4.496|<|0.0001|TWO_SIDED|95.0|11.795|29.431|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||29.431|11.795|<0.0001
73873461|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
73873462|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
73873463|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73873464|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873465|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
73980964|NCT00092456|147507204|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
73980965|NCT00092456|147507204|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2)|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
73980966|NCT00092456|147507204|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANCOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
73980967|NCT02834624|147507214|OTHER||||||<|0.05|||||||t-test, 1 sided|||Sample size calculations used a Chi-square for independence, u = 1, p =.05, power = .80, effect size = .60, which required 22 total subjects.||||<.05
73980968|NCT02834624|147507216|OTHER|||||||0.63|||||||t-test, 1 sided|||||||0.63
73980969|NCT05066230|147507239|SUPERIORITY||Difference of weighted percentages|39.7|||<|0.0001|TWO_SIDED|95.02|31.3|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||48.1|31.3|<0.0001
74089521|NCT01172821|147731719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.757|STANDARD_ERROR_OF_MEAN|4.513|<|0.0001|TWO_SIDED|95.0|15.907|33.607|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||33.607|15.907|<0.0001
74089522|NCT01172821|147731720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.991|STANDARD_ERROR_OF_MEAN|4.547||0.0004|TWO_SIDED|95.0|7.074|24.908|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||24.908|7.074|0.0004
73873466|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873467|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873468|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
73873469|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.9|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.90
73873470|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
74033331|NCT01763905|147619306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.8|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-79.2|-58.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-58.4|-79.2|<0.001
73873471|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73873472|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73873473|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873474|NCT01128426|147289446|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873475|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873476|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
74033332|NCT01763905|147619307|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|43.5|||<|0.001|TWO_SIDED|95.0|30.9|53.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||53.4|30.9|<0.001
73873477|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
73873478|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
73873479|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73953622|NCT01033643|147441376|OTHER|Linear Model|Mean Difference from Placebo|-0.74|||||TWO_SIDED|90.0|-5.91|4.44||||||||4.44|-5.91|
73953623|NCT01033643|147441376|OTHER|Linear Model|Mean Difference from Placebo|-2.81|||||TWO_SIDED|90.0|-8.64|3.02||||||||3.02|-8.64|
73953624|NCT01033643|147441377|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.47|1.87|||||GMR was calculated as MK-3614 Dose divided by Placebo|||1.87|0.47|
73873480|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873481|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873482|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873483|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73873484|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
73873485|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
73873486|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873487|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873488|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873489|NCT01128426|147289446|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73953625|NCT01033643|147441377|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.48|||||TWO_SIDED|90.0|0.26|0.87|||||GMR was calculated as MK-3614 Dose divided by Placebo|||0.87|0.26|
73953626|NCT01033643|147441377|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.95|||||TWO_SIDED|90.0|0.51|1.79|||||GMR was calculated as MK-3614 Dose divided by Placebo|||1.79|0.51|
73953627|NCT01106976|147441396|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0012||||0.0009|TWO_SIDED||||||t-test, 1 sided|||Paired t-test. Hypothesis of significant cholinergic interval changes over the study interval period.||||0.0009
74033333|NCT01763905|147619307|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|42.0|||<|0.001|TWO_SIDED|95.0|30.3|51.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||51.8|30.3|<0.001
74033334|NCT01763905|147619308|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|48.0|||<|0.001|TWO_SIDED|95.0|35.0|57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||57.8|35.0|<0.001
74033335|NCT01763905|147619308|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|37.5|||<|0.001|TWO_SIDED|95.0|25.5|47.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||47.5|25.5|<0.001
74033336|NCT01763905|147619309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.53|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-36.34|-26.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-26.73|-36.34|<0.001
74033337|NCT01763905|147619309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.58|STANDARD_ERROR_OF_MEAN|2.05|<|0.001|TWO_SIDED|95.0|-38.63|-30.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-30.54|-38.63|<0.001
74033338|NCT01763905|147619310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.09|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|-37.28|-26.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-26.90|-37.28|<0.001
74033339|NCT01763905|147619310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.99|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-37.19|-28.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.79|-37.19|<0.001
73873490|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
74033340|NCT01763905|147619311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.2|STANDARD_ERROR_OF_MEAN|2.39|<|0.001|TWO_SIDED|95.0|-36.92|-27.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-27.49|-36.92|<0.001
74033341|NCT01763905|147619311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.99|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-39.59|-30.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-30.39|-39.59|<0.001
73873491|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
73873492|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
74033342|NCT01763905|147619312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.86|STANDARD_ERROR_OF_MEAN|2.62|<|0.001|TWO_SIDED|95.0|-38.04|-27.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-27.68|-38.04|<0.001
73873493|NCT01128426|147289447|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
74033343|NCT01763905|147619312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.1|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-38.04|-28.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.17|-38.04|<0.001
74033344|NCT01763905|147619313|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.39|STANDARD_ERROR_OF_MEAN|2.39|<|0.001|TWO_SIDED|95.0|-32.11|-22.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-22.67|-32.11|<0.001
74033345|NCT01763905|147619313|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.94|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-34.72|-25.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-25.17|-34.72|<0.001
74033346|NCT01763905|147619314|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.28|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-31.42|-21.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-21.15|-31.42|<0.001
74033347|NCT01763905|147619314|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.66|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-33.88|-23.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-23.43|-33.88|<0.001
74033348|NCT01763905|147619315|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.86|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-39.84|-29.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-29.88|-39.84|<0.001
73873494|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73953628|NCT04003974|147441485|OTHER|Mean DUX4 activity was derived for each participant at each time point (Baseline and post-Baseline) based on normalized gene expression values for the 6-gene panel. Changes from Baseline to post-Baseline were analyzed using an ANCOVA model.|Least square mean difference|0.4284||||0.5621|TWO_SIDED|95.0|-1.0376|1.8945|||ANCOVA||Results are expressed as difference in Least-Squares (LS) means of the changes from Baseline to post-Baseline in DUX4 activity for each group, losmapimod and placebo.|||1.8945|-1.0376|0.5621
73953629|NCT00335153|147441523|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953630|NCT00335153|147441524|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
73953631|NCT00335153|147441525|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953632|NCT00335153|147441526|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953633|NCT00335153|147441527|SUPERIORITY_OR_OTHER|||||||0.974|||||||t-test, 2 sided|||||||0.974
73953634|NCT00335153|147441528|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953635|NCT00335153|147441529|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953636|NCT00335153|147441530|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953637|NCT00335153|147441531|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953638|NCT00335153|147441532|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953639|NCT00335153|147441533|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953640|NCT00335153|147441534|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953641|NCT00335153|147441535|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953642|NCT00335153|147441536|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953643|NCT00335153|147441537|SUPERIORITY_OR_OTHER|||||||0.757|||||||t-test, 2 sided|||||||0.757
73953644|NCT00335153|147441538|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953645|NCT00335153|147441539|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953646|NCT00335153|147441540|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953647|NCT00335153|147441541|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73953648|NCT00335153|147441542|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73873495|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73873496|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73953649|NCT00335153|147441543|SUPERIORITY_OR_OTHER|||||||0.824|||||||t-test, 2 sided|||||||0.824
73953650|NCT03688542|147441557|SUPERIORITY||Slope|-1.4|||<|0.05|TWO_SIDED|95.0|-3.8|1.0|||Regression, Linear|Dependant variable = follow-up value; adjusted for baseline value, canton, avg number of residents, mission||||1.0|-3.8|<0.05
73953651|NCT03688542|147441558|SUPERIORITY||Slope|-0.18|||<|0.05|TWO_SIDED|95.0|-0.39|0.03|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||0.03|-0.39|<0.05
73953652|NCT03688542|147441559|SUPERIORITY||Slope|-0.035|||<|0.05|TWO_SIDED|95.0|-0.095|0.025|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||0.025|-0.095|<0.05
73953653|NCT03688542|147441560|SUPERIORITY||Slope|-0.237|||<|0.05|TWO_SIDED|95.0|-0.435|-0.04|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||-0.040|-0.435|<0.05
73953654|NCT03688542|147441561|SUPERIORITY||Slope|1.55|||<|0.05|TWO_SIDED|95.0|0.164|2.938|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.||||2.938|0.164|<0.05
73953655|NCT03688542|147441562|SUPERIORITY||Slope|-12.7|||<|0.05|TWO_SIDED|95.0|-21.5|-4.0|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.||||-4.0|-21.5|<0.05
73953656|NCT03688542|147441563|SUPERIORITY||Slope|-0.165|||<|0.05|TWO_SIDED|95.0|-0.754|0.424|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents||||0.424|-0.754|<0.05
73953657|NCT03688542|147441564|SUPERIORITY||Slope|-4.2|||<|0.05|TWO_SIDED|95.0|-16.0|7.6|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents||||7.6|-16.0|<0.05
73953658|NCT02478359|147441567|SUPERIORITY||Odds Ratio (OR)|1.09||||0.33|TWO_SIDED|95.0|0.92|1.28|||Regression, Logistic|||||1.28|0.92|0.33
73953659|NCT02478359|147441568|SUPERIORITY||Odds Ratio (OR)|1.02||||0.88|TWO_SIDED|95.0|0.77|1.36|||Regression, Logistic|||||1.36|0.77|0.88
73953660|NCT02478359|147441569|SUPERIORITY||Odds Ratio (OR)|1.05||||0.53|TWO_SIDED|95.0|0.89|1.24|||Regression, Logistic|||||1.24|0.89|0.53
73953661|NCT02478359|147441570|SUPERIORITY||Odds Ratio (OR)|1.03||||0.73|TWO_SIDED|95.0|0.88|1.2|||Regression, Logistic|||||1.20|0.88|0.73
73953662|NCT02478359|147441571|SUPERIORITY||Odds Ratio (OR)|1.13||||0.21|TWO_SIDED|95.0|0.93|1.37|||Regression, Logistic|||||1.37|0.93|0.21
73953663|NCT02478359|147441572|SUPERIORITY||Odds Ratio (OR)|1.1||||0.26|TWO_SIDED|95.0|0.93|1.31|||Regression, Logistic|||||1.31|0.93|0.26
73953664|NCT02478359|147441573|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
73953665|NCT02478359|147441574|SUPERIORITY|||||||0.55|||||||Regression, Linear|||||||0.55
73953666|NCT02478359|147441575|SUPERIORITY|||||||0.34||||||adjusted p values|Regression, Logistic|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.34
73953667|NCT02478359|147441576|SUPERIORITY|||||||0.6|||||||Regression, Linear|||||||0.60
73953668|NCT02478359|147441577|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
73953669|NCT02478359|147441578|SUPERIORITY|||||||0.47|||||||Regression, Linear|||||||0.47
73953670|NCT02478359|147441579|SUPERIORITY|||||||0.33|||||||Regression, Linear|||||||0.33
74033349|NCT01763905|147619315|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.37|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-41.73|-31.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-31.01|-41.73|<0.001
74033350|NCT01763905|147619316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.53|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-40.05|-29.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-29.00|-40.05|<0.001
74033351|NCT01763905|147619316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.13|STANDARD_ERROR_OF_MEAN|2.91|<|0.001|TWO_SIDED|95.0|-39.87|-28.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.39|-39.87|<0.001
74033352|NCT01763905|147619317|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.9|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-31.27|-16.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.54|-31.27|<0.001
74033353|NCT01763905|147619317|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.26|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-33.75|-16.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.77|-33.75|<0.001
74033354|NCT01763905|147619318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.29|STANDARD_ERROR_OF_MEAN|4.03|<|0.001|TWO_SIDED|95.0|-33.26|-17.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-17.33|-33.26|<0.001
74033355|NCT01763905|147619318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.88|STANDARD_ERROR_OF_MEAN|5.73|<|0.001|TWO_SIDED|95.0|-39.21|-16.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.56|-39.21|<0.001
74033356|NCT01763905|147619319|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.59|STANDARD_ERROR_OF_MEAN|4.45||0.97|TWO_SIDED|95.0|-11.38|6.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.20|-11.38|0.97
74033357|NCT01763905|147619319|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-6.42|STANDARD_ERROR_OF_MEAN|5.13||0.33|TWO_SIDED|95.0|-16.55|3.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||3.71|-16.55|0.33
74033358|NCT01763905|147619320|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|1.58|STANDARD_ERROR_OF_MEAN|4.92||0.97|TWO_SIDED|95.0|-8.14|11.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||11.31|-8.14|0.97
73873497|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73953671|NCT02478359|147441580|SUPERIORITY|||||||0.87||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.87
73953672|NCT02478359|147441581|SUPERIORITY|||||||0.7||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.70
73953673|NCT02478359|147441582|SUPERIORITY|||||||0.35|||||||Regression, Linear|Adjusted P Values||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.35
73953674|NCT02478359|147441583|SUPERIORITY|||||||0.09||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.09
73953675|NCT02478359|147441584|SUPERIORITY|||||||0.82||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.82
73953676|NCT02478359|147441585|SUPERIORITY|||||||0.16||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.16
73953677|NCT02478359|147441586|SUPERIORITY|||||||0.86||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.86
73953678|NCT02478359|147441587|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
73953679|NCT02478359|147441588|SUPERIORITY||Odds Ratio (OR)|1.05||||0.69|TWO_SIDED|95.0|0.82|1.35|||Regression, Logistic|||||1.35|0.82|0.69
73980970|NCT05066230|147507240|SUPERIORITY||Difference of weighted percentages|-18.7|||<|0.0001|TWO_SIDED|95.02|-26.2|-11.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||-11.2|-26.2|<0.0001
73953680|NCT02478359|147441589|SUPERIORITY||Odds Ratio (OR)|0.62||||0.11|TWO_SIDED|95.0|0.35|1.11|||Regression, Logistic|||||1.11|0.35|0.11
73953681|NCT02478359|147441590|SUPERIORITY||Odds Ratio (OR)|0.84||||0.21|TWO_SIDED|95.0|0.65|1.1|||Regression, Logistic|||||1.10|0.65|0.21
73980971|NCT05066230|147507241|SUPERIORITY||Difference of weighted percentages|5.6||||0.0058|TWO_SIDED|95.02|1.6|9.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53), HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||9.5|1.6|0.0058
73980972|NCT05066230|147507242|SUPERIORITY||Difference of weighted percentages|-6.5||||0.0149|TWO_SIDED|95.02|-11.8|-1.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||-1.3|-11.8|0.0149
73980973|NCT02164578|147507254|SUPERIORITY|||||||0.004|||||||ANCOVA|ANCOVA for repeated measurements with baseline as covariate||The hypothesis H0 is tested against the one-sided alternative hypothesis H1 H0: µ∆FBF,Riva, week 20 ≤ µ∆FBF, ASA, week 20 versus H1: µΔFBF, Riva, week 20 \> µΔFBF, ASA, week 20 by test procedures for continuous data.||||0.004
73980974|NCT02164578|147507255|OTHER|||||||0.07|||||||ANCOVA|||||||0.070
73980975|NCT02164578|147507256|OTHER|||||||0.045|||||||ANCOVA|ANCOVA for repeated measurements with baseline as covariate||||||0.045
74033359|NCT01763905|147619320|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-4.69|STANDARD_ERROR_OF_MEAN|6.25||0.33|TWO_SIDED|95.0|-17.04|7.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||7.67|-17.04|0.33
73980976|NCT02164578|147507257|OTHER|||||||0.125|||||||ANCOVA|||||||0.125
73980977|NCT02164578|147507258|OTHER|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
73980978|NCT02164578|147507259|OTHER|||||||0.589|||||||Wilcoxon (Mann-Whitney)|||||||0.589
73873498|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
73953682|NCT02478359|147441591|SUPERIORITY||Odds Ratio (OR)|1.07||||0.6|TWO_SIDED|95.0|0.84|1.36|||Regression, Logistic|||||1.36|0.84|0.60
73953683|NCT02478359|147441592|SUPERIORITY||Odds Ratio (OR)|0.92||||0.63|TWO_SIDED|95.0|0.66|1.28|||Regression, Logistic|||||1.28|0.66|0.63
73953684|NCT02478359|147441593|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8|TWO_SIDED|95.0|0.68|1.35|||Regression, Logistic|||||1.35|0.68|0.80
73953685|NCT02478359|147441594|SUPERIORITY|||||||0.06||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.06
73953686|NCT02478359|147441595|SUPERIORITY|||||||0.07||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.07
73953687|NCT02478359|147441596|SUPERIORITY|||||||0.67||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.67
73953688|NCT02478359|147441597|SUPERIORITY|||||||0.13||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.13
73953689|NCT02478359|147441598|SUPERIORITY|||||||0.34||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.34
73953690|NCT02478359|147441599|SUPERIORITY|||||||0.11||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.11
73980979|NCT01241448|147507269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.29||||0.094|TWO_SIDED|90.0|-0.58|-0.01||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.01|-0.58|0.094
73873499|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.58|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.58
73953691|NCT02478359|147441600|SUPERIORITY|||||||0.83||||||Adjusted P value|Regression, Linear|||Covariated included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.83
73953692|NCT01818700|147441613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|STANDARD_DEVIATION|1.96|<|0.05|TWO_SIDED|95.0|-10.0|10.0|||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."||||10|-10|<0.05
73953693|NCT04833855|147441635|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|2.2||0.99|TWO_SIDED|95.0|-4.3|4.4||Nominal p-value|Repeated measure model|Model parameters: stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week, interaction between treatment and study week.|Tezepelumab 210 mg SC Q4W - Placebo|||4.4|-4.3|0.99
73953694|NCT04833855|147441635|SUPERIORITY||LSM difference|-1.1|STANDARD_ERROR_OF_MEAN|2.2||0.6|TWO_SIDED|95.0|-5.4|3.1||Nominal p-value|Repeated measure model|Model parameters: stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week, interaction between treatment and study week.|Tezepelumab 420 mg SC Q2W - Placebo|||3.1|-5.4|0.60
73953695|NCT03682536|147441677|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|2.0|4.8|||Cochran-Mantel-Haenszel|||||4.8|2.0|<.0001
73980980|NCT01241448|147507269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.62|||<|0.001|TWO_SIDED|90.0|-0.9|-0.34||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.34|-0.90|<0.001
73980981|NCT01241448|147507269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.77|||<|0.01|TWO_SIDED|90.0|-1.05|-0.48||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.48|-1.05|<0.01
73873500|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
73953696|NCT03682536|147441678|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0003|TWO_SIDED|95.0|1.4|3.7|||Cochran-Mantel-Haenszel|||||3.7|1.4|0.0003
73953697|NCT03682536|147441680|SUPERIORITY||Odds Ratio (OR)|2.8|||<|0.0001|TWO_SIDED|95.0|1.8|4.5|||Cochran-Mantel-Haenszel|||||4.5|1.8|<.0001
73953698|NCT03682536|147441682|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.6|4.0|||Cochran-Mantel-Haenszel|||||4.0|1.6|<.0001
73953699|NCT03682536|147441683|SUPERIORITY||Hazard Ratio (HR)|0.534||||0.0096|TWO_SIDED|95.0|0.33|0.864|||Log Rank||Calculated by Cox proportional hazard model|||0.864|0.330|0.0096
73953700|NCT03682536|147441687|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0007|TWO_SIDED|95.0|1.4|3.8|||Cochran-Mantel-Haenszel|||||3.8|1.4|0.0007
73953701|NCT03682536|147441688|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.6|4.3|||Cochran-Mantel-Haenszel|||||4.3|1.6|<.0001
73873501|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.39|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.39
73953702|NCT03298815|147441812|SUPERIORITY|||||||0.375|||||||McNemar|||||||0.375
73953703|NCT03298815|147441813|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||||||0.391
73953704|NCT03298815|147441814|SUPERIORITY|||||||0.267|||||||Wilcoxon (Mann-Whitney)|||||||0.267
73953705|NCT03298815|147441815|SUPERIORITY|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||||||0.445
73953706|NCT03298815|147441816|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.250
73980982|NCT03740737|147507285|OTHER||Treatment difference|63.0|||<|0.001|TWO_SIDED|95.0|55.5|67.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|||67.1|55.5|<0.001
73980983|NCT03740737|147507286|OTHER||Treatment difference|29.5|||<|0.001|TWO_SIDED|95.0|22.5|33.7|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Ongoing Pregnancy Rate in the Fresh Cycle||33.7|22.5|<0.001
73980984|NCT03740737|147507290|OTHER||Treatment difference|31.8|||<|0.001|TWO_SIDED|95.0|24.7|36.0|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate in the fresh cycle||36.0|24.7|<0.001
73980985|NCT03740737|147507290|OTHER||Treatment difference|68.2|||<|0.001|TWO_SIDED|95.0|61.2|72.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate cumulatively||72.1|61.2|<0.001
73873502|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
73953707|NCT03298815|147441817|SUPERIORITY||||||<|1|||||||Wilcoxon (Mann-Whitney)|||||||<1.00
73953708|NCT03298815|147441818|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
73953709|NCT03298815|147441819|SUPERIORITY|||||||0.563|||||||Wilcoxon (Mann-Whitney)|||||||0.563
73953710|NCT03298815|147441820|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
73953711|NCT03298815|147441821|SUPERIORITY|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.156
73953712|NCT03298815|147441822|SUPERIORITY|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
73953713|NCT03298815|147441823|SUPERIORITY|||||||0.594||||||30 day visit|Wilcoxon (Mann-Whitney)|||||||0.594
73873503|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
73953714|NCT03298815|147441823|SUPERIORITY|||||||0.469||||||60 day visit|Wilcoxon (Mann-Whitney)|||||||0.469
73953715|NCT03298815|147441823|SUPERIORITY|||||||0.75||||||100 day visit|Wilcoxon (Mann-Whitney)|||||||0.750
73953716|NCT03298815|147441824|SUPERIORITY|||||||0.063||||||30 day visit|Wilcoxon (Mann-Whitney)|||||||0.063
73953717|NCT03298815|147441824|SUPERIORITY||||||<|1||||||60 day visit|Wilcoxon (Mann-Whitney)|||||||<1.000
73980986|NCT03740737|147507291|OTHER||Treatment difference|30.5|||<|0.001|TWO_SIDED|95.0|23.4|34.6|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate in the fresh cycle||34.6|23.4|<0.001
73980987|NCT03740737|147507291|OTHER||Treatment difference|65.1|||<|0.001|TWO_SIDED|95.0|57.5|69.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate cumulatively||69.1|57.5|<0.001
73980988|NCT03740737|147507293|OTHER||Treatment difference|35.0|||<|0.001|TWO_SIDED|95.0|28.1|39.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate in the fresh cycle||39.2|28.1|<0.001
73953718|NCT03298815|147441824|SUPERIORITY|||||||0.25||||||100 day visit|Wilcoxon (Mann-Whitney)|||||||0.250
73953719|NCT04060680|147441843|SUPERIORITY|The pre-specified Objective Performance Criterion (OPC) for the major complication free rate at 6 months is 0.79. If the lower confidence bound of two-sided 95% confidence interval for the freedom from the first major EV ICD System/procedure-related complication through 182 days post implant exceeds 0.79, the primary safety objective will be met. The freedom from the first major EV ICD System/procedure-related complication was estimated using the Kaplan-Meier method.|Major complication-free rate|92.6|||<|0.0001|TWO_SIDED|95.0|89.0|95.0||A priori threshold for statistical significance is 0.025|Kaplan-Meier method|||The primary safety objective is to demonstrate the freedom from major complications related to the EV ICD System and/or procedure at 6 months post-implant exceeds an OPC of 79%. H0: p ≤ 0.79 HA: p \> 0.79, where p denotes the 6-month (182 days) freedom from major EV ICD System/procedure-related complications rate.||95.0|89.0|<0.0001
73953720|NCT04060680|147441844|SUPERIORITY|The pre-specified OPC for the EV ICD defibrillation testing success at implant is 0.88. If the lower confidence bound of two-sided 95% confidence interval for the proportion of EV ICD patients achieving defibrillation testing success at implant exceeds 0.88, the primary efficacy objective will be met. The primary efficacy objective will be evaluated using a one-proportion binomial exact test along with a two-sided 95% Clopper-Pearson confidence bound.|Proportion|98.7|||<|0.0001|TWO_SIDED|95.0|96.6|99.6||A priori threshold for statistical significance is 0.025|One-proportion binomial exact test|||The primary efficacy is to demonstrate the EV ICD defibrillation testing success rate at implant is greater than an OPC of 88%. H0: p ≤ 0.88 HA: p \> 0.88, where p denotes the probability of EV ICD defibrillation success at implant.||99.6|96.6|<0.0001
73953721|NCT00935792|147441846|OTHER||||||||||||||||||Estimated maximum tolerated dose was 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.|||
73953722|NCT02322775|147441852|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.08||||0.04|TWO_SIDED|95.0|0.0|0.15||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||The null hypothesis was: H0: Change from baseline in pre-bronchodilator FEV1 (L) at Week 12 (benralizumab vs placebo)=0.||0.15|0|0.040
73980989|NCT03740737|147507293|OTHER||Treatment difference|72.4|||<|0.001|TWO_SIDED|95.0|65.3|76.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate cumulatively||76.2|65.3|<0.001
73980990|NCT03740737|147507305|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
73980991|NCT03740737|147507306|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
73980992|NCT03740737|147507307|OTHER|||||||0.22|||||||Fisher Exact|||||||0.220
73980993|NCT03740737|147507308|OTHER|||||||0.588|||||||Fisher Exact|||||||0.588
73953723|NCT02322775|147441853|SUPERIORITY_OR_OTHER||Difference of Least Square Means|8.84||||0.233|TWO_SIDED|95.0|-5.74|23.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||23.42|-5.74|0.233
73953724|NCT02322775|147441854|SUPERIORITY_OR_OTHER||Difference of Least Square Means|5.29||||0.456|TWO_SIDED|95.0|-8.67|19.25||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||19.25|-8.67|0.456
74033360|NCT01763905|147619321|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.15|STANDARD_ERROR_OF_MEAN|2.23||0.068|TWO_SIDED|95.0|0.74|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||9.56|0.74|0.068
73873504|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73953725|NCT02322775|147441855|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.13||||0.266|TWO_SIDED|95.0|-0.35|0.1||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.10|-0.35|0.266
73953726|NCT02322775|147441856|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.36||||0.2|TWO_SIDED|95.0|-0.91|0.19||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.19|-0.91|0.200
73953727|NCT02322775|147441857|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.03||||0.38|TWO_SIDED|95.0|-0.08|0.03||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.03|-0.08|0.380
73953728|NCT02322775|147441858|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.17||||0.114|TWO_SIDED|95.0|-0.39|0.04||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.04|-0.39|0.114
73953729|NCT02322775|147441860|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.21||||0.055|TWO_SIDED|95.0|0.0|0.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Total score||0.42|0|0.055
73953730|NCT02322775|147441860|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.23||||0.063|TWO_SIDED|95.0|-0.01|0.47||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Symptoms score||0.47|-0.01|0.063
73953731|NCT02322775|147441860|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.2||||0.061|TWO_SIDED|95.0|-0.01|0.41||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Activity limitation score||0.41|-0.01|0.061
73953732|NCT02322775|147441860|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.19||||0.156|TWO_SIDED|95.0|-0.07|0.45||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Emotional function score||0.45|-0.07|0.156
73980994|NCT03034863|147507355|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.03|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
73980995|NCT03034863|147507356|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.69
73980996|NCT03034863|147507357|SUPERIORITY|||||||0.49||||||All p-values are two-tailed|Fisher Exact|Compares veterans who reported 1+ attempts at any follow-up wave out of total number of veterans in each group (i.e., 0/19 for SAFER; 2/20 for I-SPI).||||||.49
73980997|NCT03034863|147507358|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
73980998|NCT03034863|147507359|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.87|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.87
73980999|NCT03034863|147507360|SUPERIORITY||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
74033361|NCT01763905|147619321|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.74|STANDARD_ERROR_OF_MEAN|2.28||0.13|TWO_SIDED|95.0|1.23|10.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||10.24|1.23|0.13
74033362|NCT01763905|147619322|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.57|STANDARD_ERROR_OF_MEAN|2.56||0.068|TWO_SIDED|95.0|-1.49|8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||8.63|-1.49|0.068
73873505|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73873506|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
73873507|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
73873508|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73873509|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.32|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.32
73873510|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
73873511|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
73873512|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
73873513|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.58|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.58
73873514|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
73873515|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
73873516|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73953733|NCT02322775|147441860|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.19||||0.135|TWO_SIDED|95.0|-0.06|0.44||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Environmental stimuli score||0.44|-0.06|0.135
73953734|NCT04739423|147441883|OTHER||Least Squares Mean|5.4822||||0.0479|TWO_SIDED|95.0|0.0575|10.9069|||Mixed Models Analysis|||Between treatment analysis for Accuracy for happiness - change from baseline to Day 14.||10.9069|0.0575|0.0479
73953735|NCT04739423|147441883|OTHER||Least Squares Mean|4.7954||||0.0161|TWO_SIDED|95.0|0.9843|8.6064|||Mixed Models Analysis|||Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14||8.6064|0.9843|0.0161
73873517|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873518|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873519|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873520|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73953736|NCT04739423|147441883|OTHER||Least Squares Mean|167.29||||0.0237|TWO_SIDED|95.0|25.36|309.23|||Mixed Models Analysis|||Between treatment analysis of Reaction time for anger - change from baseline to Day 7||309.23|25.36|0.0237
73953737|NCT04739423|147441883|OTHER||Least Squares Mean|-1.2761||||0.7188|TWO_SIDED|95.0|-9.2424|6.6902|||Mixed Models Analysis|||Between treatment analysis for Accuracy for happiness - change from baseline to Day 14||6.6902|-9.2424|0.7188
73953738|NCT04739423|147441883|OTHER||Least Squares Mean|1.8955||||0.5478|TWO_SIDED|95.0|-4.9026|8.6935|||Mixed Models Analysis|||Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14||8.6935|-4.9026|0.5478
73953739|NCT04739423|147441883|OTHER||Least Squares Mean|-7.52||||0.951|TWO_SIDED|95.0|-291.21|276.17|||Mixed Models Analysis|||Between treatment analysis of Reaction time for anger - change from baseline to Day 7||276.17|-291.21|0.9510
74033363|NCT01763905|147619322|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.83|STANDARD_ERROR_OF_MEAN|2.52||0.13|TWO_SIDED|95.0|-0.16|9.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||9.81|-0.16|0.13
73953740|NCT04739423|147441885|OTHER||Least Squares Mean|0.68||||0.0737|TWO_SIDED|95.0|-0.066|1.432|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.432|-0.066|0.0737
73953741|NCT04739423|147441885|OTHER||Least Squares Mean|1.12||||0.0033|TWO_SIDED|95.0|0.382|1.868|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose||1.868|0.382|0.0033
73953742|NCT04739423|147441885|OTHER||Least Squares Mean|1.72||||0.0029|TWO_SIDED|95.0|0.6|2.84|||Mixed Models Analysis|||Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||2.840|0.600|0.0029
73953743|NCT04739423|147441885|OTHER||Least Squares Mean|1.29||||0.0247|TWO_SIDED|95.0|0.168|2.418|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.418|0.168|0.0247
73953744|NCT04739423|147441885|OTHER||Least Squares Mean|1.69||||0.0016|TWO_SIDED|95.0|0.653|2.732|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.732|0.653|0.0016
73953745|NCT04739423|147441885|OTHER||Least Squares Mean|-0.06||||0.9126|TWO_SIDED|95.0|-1.127|1.009|||Mixed Models Analysis|||Between treatment analysis for Immediate Word recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.009|-1.127|0.9126
73953746|NCT04739423|147441885|OTHER||Least Squares Mean|-0.24||||0.657|TWO_SIDED|95.0|-1.317|0.837|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose||0.837|-1.317|0.6570
73953747|NCT04739423|147441885|OTHER||Least Squares Mean|-0.06||||0.9458|TWO_SIDED|95.0|-1.787|1.669|||Mixed Models Analysis|||Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.669|-1.787|0.9458
73953748|NCT04739423|147441885|OTHER||Least Squares Mean|0.97||||0.2327|TWO_SIDED|95.0|-0.642|2.579|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.579|-0.642|0.2327
73953749|NCT04739423|147441885|OTHER||Least Squares Mean|0.84||||0.4154|TWO_SIDED|95.0|-1.208|2.879|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to day 7, 4 hours post-dose||2.879|-1.208|0.4154
73953750|NCT04739423|147441886|OTHER||Least Squares Mean|5.06|||<|0.0001|TWO_SIDED|95.0|3.956|6.16|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for Sleeping Heart Rate change from baseline across periods||6.160|3.956|<0.0001
73953751|NCT04739423|147441887|OTHER||Least Squares Mean|1.0||||0.0017|TWO_SIDED|95.0|0.432|1.565|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for sleeping HRV change from baseline across periods.||1.565|0.432|0.0017
73953752|NCT04739423|147441888|OTHER||Least Squares Mean|-10.22||||0.0049|TWO_SIDED|95.0|-16.867|-3.567|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for sleeping HRV root mean square of successive differences change from baseline across periods||-3.567|-16.867|0.0049
73953753|NCT02507219|147441922|SUPERIORITY||Slope|0.000055||||0.512|TWO_SIDED|95.0|-0.00011|0.00022|||Mixed Models Analysis||Slope is percent signal change per milligram of ibuprofen.|A linear mixed effects model was run for the left amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.||0.00022|-0.00011|0.512
73953754|NCT02507219|147441922|SUPERIORITY||Slope|-0.00012||||0.221|TWO_SIDED|95.0|-0.0003|0.000067|||Mixed Models Analysis||Slope is the percent signal change per mg of ibuprofen.|A linear mixed effects model was run for the right amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.||0.000067|-0.00030|0.221
73953755|NCT00819234|147441931|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.23|STANDARD_ERROR_OF_MEAN|2.863||0.0135|TWO_SIDED|95.0|-12.93|-1.54|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons.||-1.54|-12.93|0.0135
73953756|NCT00819234|147441931|SUPERIORITY_OR_OTHER||LS Mean|-6.55|STANDARD_ERROR_OF_MEAN|2.681||0.0168|TWO_SIDED|95.0|-11.89|-1.21|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons||-1.21|-11.89|0.0168
73953757|NCT00819234|147441931|SUPERIORITY_OR_OTHER||LS Mean|-5.52|STANDARD_ERROR_OF_MEAN|2.887||0.0595|TWO_SIDED|95.0|-11.27|0.23|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons||0.23|-11.27|0.0595
73953758|NCT05174065|147441951|SUPERIORITY||Adjusted Difference in Proportion|32.6|||<|0.0001|TWO_SIDED|95.0|18.7|46.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of rounded PPPASI total score range (≤ 20/21 to 30/≥ 31) and focal infection status (yes/no) at baseline.|Based on the Cochran-Mantel-Haenszel method adjusting for the stratification factors. The adjusted difference in proportion was the weighted average of the treatment differences across strata.|||46.5|18.7|<0.0001
73953759|NCT05174065|147441952|SUPERIORITY||Difference in Least Squares Mean|-6.13|||<|0.0001|TWO_SIDED|95.0|-8.57|-3.69|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-3.69|-8.57|<0.0001
73953760|NCT05174065|147441953|SUPERIORITY||Difference in Least Squares Mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and baseline value as covariate.|Apremilast - Placebo|||-0.9|-2.2|<0.0001
73953761|NCT05174065|147441954|SUPERIORITY||Difference in Least Squares Mean|-7.8||||0.033|TWO_SIDED|95.0|-14.9|-0.6|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-0.6|-14.9|0.0330
73953762|NCT05174065|147441955|SUPERIORITY||Difference in Least Squares Mean|-10.8||||0.0076|TWO_SIDED|95.0|-18.6|-2.9|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-2.9|-18.6|0.0076
73953763|NCT05174065|147441956|SUPERIORITY||Difference in Least Squares Mean|-1.4||||0.0036|TWO_SIDED|95.0|-2.4|-0.5|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-0.5|-2.4|0.0036
73953764|NCT00216320|147441958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<.001
73953765|NCT02753530|147442127|SUPERIORITY||Least Square (LS) Mean Difference|-0.99||||0.1146|TWO_SIDED|95.0|-2.23|0.24||Primary Estimand (Treatment Policy)|Mixed Models Analysis|||The baseline observation was the last observation recorded prior to the first dose of study medication. The change from baseline in IBMFRS total score was analyzed using a Mixed Models for Repeated Measures (MMRM) with treatment interacting with visit and trial site as factors. Baseline IBMFRS total score interacting with visit was further included as covariate. An unstructured covariance matrix was assumed.||0.24|-2.23|0.1146
73953766|NCT00231179|147442159|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes were established when the trial was first developed. For all power calculations, we set alpha = .05 and beta = .20 and specified 2-tailed tests.|Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|15.0||0.59|TWO_SIDED|95.0|0.31|2.13||Bonferroni corrections were made for multiple comparisons.|t-test, 2 sided|||We compared scores for verbal, performance, and full scale Intelligence Quotient (IQ).||2.13|0.31|0.59
73953767|NCT00231179|147442160|NON_INFERIORITY_OR_EQUIVALENCE|Please see earlier power calculation.|Hazard Ratio (HR)|10.0|STANDARD_ERROR_OF_MEAN|5.0||0.72|TWO_SIDED|95.0|||||Chi-squared|||||||0.72
73953768|NCT00231179|147442161|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|10.0|STANDARD_ERROR_OF_MEAN|5.0|<|0.01|TWO_SIDED|95.0|||||Chi-squared|||||||<0.01
73953769|NCT00231179|147442162|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|3.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
73953770|NCT00231179|147442163|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|3.0|STANDARD_ERROR_OF_MEAN|3.0||0.64|TWO_SIDED|95.0|||||Chi-squared|||||||0.64
73953771|NCT02401529|147442174|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|||||||0.033
73953772|NCT02401529|147442175|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||||||0.026
73953773|NCT02401529|147442176|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||Chi-squared|||||||0.016
73953774|NCT02401529|147442177|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
73953775|NCT02401529|147442178|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Chi-squared|||||||0.012
73953776|NCT02401529|147442179|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||||||0.024
73953777|NCT02401529|147442180|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
73953778|NCT02401529|147442181|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Chi-squared|||||||0.017
73953779|NCT02401529|147442182|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||||||0.026
73953780|NCT02401529|147442183|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
73953781|NCT01955382|147442205|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73953782|NCT02054247|147442321|SUPERIORITY|||||||0.442|||||||ANOVA|||||||0.442
73953783|NCT02054247|147442322|SUPERIORITY|||||||0.083|||||||ANOVA|||||||0.083
73953784|NCT02054247|147442323|SUPERIORITY|||||||0.125|||||||ANOVA|||||||0.125
73953785|NCT02054247|147442324|SUPERIORITY|||||||0.146|||||||ANOVA|||||||0.146
73953786|NCT01195675|147442325|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo|Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-0.69|1.87|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||1.87|-0.69|
73953787|NCT01195675|147442326|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-0.38|1.71|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||1.71|-0.38|
73953788|NCT01195675|147442327|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|-1.23|0.93|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||0.93|-1.23|
73953789|NCT01195675|147442328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.42|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|90.0|10.73|14.11|||ANCOVA|Based on ANCOVA with terms for treatment, period, treatment sequence, baseline and subject within sequence.|Non-confirmatory testing. Mean difference = Moxifloxacin minus placebo.|||14.11|10.73|<0.0001
74089523|NCT01172821|147731720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.247|STANDARD_ERROR_OF_MEAN|4.561|<|0.0001|TWO_SIDED|95.0|12.302|30.193|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||30.193|12.302|<0.0001
74089524|NCT01172821|147731721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.953|STANDARD_ERROR_OF_MEAN|0.598||0.1114|TWO_SIDED|95.0|-2.125|0.22|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.220|-2.125|0.1114
73953790|NCT01195675|147442329|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|2.16|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.34|4.67|||Repeated measures analysis|Based on repeated measured analysis with terms for subject, baseline, period, treatment, time, baseline by time, period by time and treatment by time.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||4.67|-0.34|
73953791|NCT01195675|147442330|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-0.35|3.53|||Repeated measures analysis|Based on repeated measured analysis with terms for subject, baseline, period, treatment, time, baseline by time, period by time and treatment by time.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||3.53|-0.35|
74089525|NCT01172821|147731721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.6||0.7665|TWO_SIDED|95.0|-1.355|0.999|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.999|-1.355|0.7665
74089526|NCT01172821|147731722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.031||0.0111|TWO_SIDED|95.0|0.018|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.140|0.018|0.0111
74089527|NCT01172821|147731722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.031||0.0395|TWO_SIDED|95.0|0.003|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.126|0.003|0.0395
73873521|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73953792|NCT01195675|147442331|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-1.39|0.94|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||0.94|-1.39|
73953793|NCT04730947|147442342|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
73953794|NCT04730947|147442343|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||0.029
73953795|NCT04730947|147442344|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
73953796|NCT04730947|147442345|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
73953797|NCT04730947|147442346|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
73953798|NCT04730947|147442347|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
73953799|NCT04730947|147442348|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
73953800|NCT04730947|147442349|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
73953801|NCT04730947|147442350|SUPERIORITY|||||||0.136|||||||t-test, 2 sided|||||||0.136
73953802|NCT01450943|147442367|SUPERIORITY||Odds Ratio (OR)|2.712595||||0.0517|TWO_SIDED|95.0|0.9141|8.4839|||Fisher Exact|||||8.4839|0.9141|0.0517
73953803|NCT01450943|147442368|SUPERIORITY||Odds Ratio (OR)|0.812339||||0.7974|TWO_SIDED|95.0|0.2543|2.5224|||Fisher Exact|||||2.5224|0.2543|0.7974
73953804|NCT05153174|147442370|EQUIVALENCE|p \< 0.05 to reject null hypothesis of equivalence||||||0.931|||||||t-test, 2 sided|||||||0.931
73981000|NCT03034863|147507361|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.16|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.16
73981001|NCT03034863|147507362|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.35||0.81|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.81
74039494|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.51||0.1605|TWO_SIDED|95.0|-1.71|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-1.71|0.1605
73953805|NCT05153174|147442371|EQUIVALENCE|p \< 0.05 to reject null hypothesis of equivalence||||||0.224|||||||t-test, 2 sided|||||||0.224
73953806|NCT00354029|147442392|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
73953807|NCT00826280|147442393|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
73953808|NCT00826280|147442393|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
73953809|NCT00826280|147442393|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
73953810|NCT00826280|147442393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9328||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.9328
73953811|NCT00826280|147442394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0011
73953812|NCT00826280|147442394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0034||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0034
73981002|NCT03034863|147507363|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.62||0.55|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.55
73953813|NCT00826280|147442394|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
73953814|NCT00826280|147442394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5902||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.5902
73953815|NCT00826280|147442395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0037
73953816|NCT00826280|147442395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0089
73953817|NCT00826280|147442395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0016
73953818|NCT00826280|147442395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5654||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.5654
73873522|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873523|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
73981003|NCT03034863|147507364|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.64|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.64
73981004|NCT03034863|147507365|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.62|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.62
73981005|NCT03034863|147507366|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.16|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.16
73981006|NCT01416285|147507439|SUPERIORITY|||||||0.004|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||All-cause death||||0.004
73981007|NCT01416285|147507439|SUPERIORITY|||||||0.003|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||Heart failure-related re-hospitalizations||||0.003
73981008|NCT01416285|147507439|SUPERIORITY||||||<|0.001|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||a composite outcome of both death and heart failure-related re-hospitalizations||||<0.001
73981009|NCT01301183|147507443|OTHER|ANCOVA||||||0.109||||||Adjusted for baseline age, height, bone density and 12-month weight change|ANCOVA|||||||.109
73981010|NCT01301183|147507444|OTHER|||||||0.344||||||Adjusted for age, height, baseline trabecular number and change in weight over 12 months|ANCOVA|||||||0.344
73981011|NCT02291861|147507447|SUPERIORITY||LSM difference|-1.9||||0.001|TWO_SIDED|95.0|-3.09|-0.79||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~The primary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 36 mg/day group and the placebo group."||-0.79|-3.09|0.001
73981012|NCT02291861|147507447|SUPERIORITY||LSM difference|-1.8||||0.003|TWO_SIDED|95.0|-3.0|-0.63||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 24 mg/day group and the placebo group, and is the third analysis in the fixed-sequence."||-0.63|-3.00|0.003
73981013|NCT02291861|147507447|SUPERIORITY||LSM difference|-0.7||||0.217|TWO_SIDED|95.0|-1.84|0.42||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 12 mg/day group and the placebo group, and is the fifth analysis in the fixed-sequence."||0.42|-1.84|0.217
73981014|NCT02291861|147507448|SUPERIORITY||Odds Ratio (OR)|2.11||||0.059|TWO_SIDED|95.0|0.96|4.645|||Cochran-Mantel-Haenszel|The statistical test was a Cochran-Mantel-Haenszel (CMH) test stratified by baseline use of dopamine receptor antagonist (DRAs).|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 36 mg/day group and the placebo group, and is the second analysis in the fixed-sequence."||4.645|0.960|0.059
74033364|NCT01763905|147619323|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.84|STANDARD_ERROR_OF_MEAN|4.35||0.97|TWO_SIDED|95.0|-10.43|6.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.75|-10.43|0.97
73873524|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73981015|NCT02291861|147507448|SUPERIORITY||Odds Ratio (OR)|2.71||||0.014|TWO_SIDED|95.0|1.211|6.052|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 24 mg/day group and the placebo group, and is the fourth analysis in the fixed-sequence."||6.052|1.211|0.014
73873525|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
73873526|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
74089528|NCT01172821|147731723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.032||0.0357|TWO_SIDED|95.0|0.005|0.131|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.131|0.005|0.0357
74089529|NCT01172821|147731723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.032||0.0422|TWO_SIDED|95.0|0.002|0.129|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.129|0.002|0.0422
74089530|NCT01172821|147731724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.171|STANDARD_ERROR_OF_MEAN|0.131||0.1927|TWO_SIDED|95.0|-0.427|0.086|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.086|-0.427|0.1927
74089531|NCT01172821|147731724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.131||0.4053|TWO_SIDED|95.0|-0.148|0.367|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.367|-0.148|0.4053
73873527|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.3|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.30
73873528|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
73981016|NCT02291861|147507448|SUPERIORITY||Odds Ratio (OR)|1.15||||0.734|TWO_SIDED|95.0|0.509|2.61|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 12 mg/day group and the placebo group, and is the sixth (last) analysis in the fixed-sequence."||2.610|0.509|0.734
73981017|NCT02291861|147507449|SUPERIORITY||LSM difference|-3.6||||0.207|TWO_SIDED|95.0|-9.18|2.0||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||2.00|-9.18|0.207
73981018|NCT02291861|147507449|SUPERIORITY||LSM difference|-3.1||||0.281|TWO_SIDED|95.0|-8.86|2.59||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||2.59|-8.86|0.281
73981019|NCT02291861|147507449|SUPERIORITY||LSM difference|1.3||||0.627|TWO_SIDED|95.0|-4.1|6.79||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||6.79|-4.10|0.627
73981020|NCT02291861|147507450|SUPERIORITY||Odds Ratio (OR)|1.51||||0.296|TWO_SIDED|95.0|0.694|3.285||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.285|0.694|0.296
73981021|NCT02291861|147507450|SUPERIORITY||Odds Ratio (OR)|1.82||||0.134|TWO_SIDED|95.0|0.826|3.994||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.994|0.826|0.134
74089532|NCT01172821|147731725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.027||0.3501|TWO_SIDED|95.0|-0.079|0.028|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.028|-0.079|0.3501
74089533|NCT01172821|147731725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.028||0.8045|TWO_SIDED|95.0|-0.047|0.061|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.061|-0.047|0.8045
74089534|NCT01172821|147731726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.0308|TWO_SIDED|95.0|1.03|1.72||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.72|1.03|0.0308
74089535|NCT01172821|147731726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0348|TWO_SIDED|95.0|1.02|1.71||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.71|1.02|0.0348
74089536|NCT00710749|147731735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44||95.0|||||Wilcoxon signed rank test|||||||0.44
74089537|NCT00710749|147731735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
74089538|NCT00710749|147731735|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
73953819|NCT00826280|147442396|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
73953820|NCT00826280|147442396|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
73953821|NCT00826280|147442396|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
73953822|NCT00826280|147442396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4246||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||.4246
73953823|NCT00180674|147442443|SUPERIORITY|||||||0.043|||||||Wilcoxon Signed Ranks test|||||||0.043
73953824|NCT02240680|147442449|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.81|-0.46|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, daily basal insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment , week and treatment by week interaction linear covariates baseline HbA1c , baseline daily basal insulin and baseline HbA1c by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|-0.46|-0.81|< 0.0001
73953825|NCT02240680|147442450|OTHER||Odds Ratio (OR)|1.464|STANDARD_ERROR_OF_MEAN|0.397||0.1594|TWO_SIDED|95.0|0.861|2.491|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For any hypoglycemia event accompanied by prespecified glucose value||2.491|0.861|0.1594
73953826|NCT02240680|147442450|OTHER||Odds Ratio (OR)|1.149|STANDARD_ERROR_OF_MEAN|0.377||0.672|TWO_SIDED|95.0|0.604|2.188|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For glucose value \< 54mg/dL according American Diabetes Association definition of clinically significant hypoglycaemia||2.188|0.604|0.6720
73953827|NCT02240680|147442451|OTHER||Odds Ratio (OR)|5.018|STANDARD_ERROR_OF_MEAN|1.818|<|0.0001|TWO_SIDED|95.0|2.468|10.206|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||10.206|2.468|< 0.0001
73953828|NCT02240680|147442452|OTHER||Odds Ratio (OR)|4.689|STANDARD_ERROR_OF_MEAN|1.519|<|0.0001|TWO_SIDED|95.0|2.485|8.848|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||8.848|2.485|< 0.0001
73953829|NCT02240680|147442453|OTHER||Odds Ratio (OR)|3.731|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|2.302|6.048|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||6.048|2.302|< 0.0001
73953830|NCT02240680|147442454|SUPERIORITY||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|4.8||0.0178|TWO_SIDED|95.0|-21.0|-2.0|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, FPG, daily insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment, week and treatment by week interaction, linear covariates baseline HbA1c, baseline daily basal insulin, baseline FPG and baseline FPG by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|-2.0|-21.0|0.0178
73953831|NCT00562965|147442455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19||||0.0358|TWO_SIDED|95.0|0.04|1.02|||Cox proportional hazard regression model|A 2-sided 5% significance level on a stratified Cox proportional hazard regression model was used.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator's choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.|To detect a hazard ratio of 0.77 with 85% power using a 2-sided log-rank test at the 5% significance level, it was planned that approximately 978 participants were needed to be randomized but due to premature termination only 29 participants were randomized.||1.02|0.04|0.0358
73953832|NCT00562965|147442456|SUPERIORITY_OR_OTHER|||||||0.0801|TWO_SIDED||||||Fisher Exact|||||||0.0801
73953833|NCT00562965|147442457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.1727|TWO_SIDED|95.0|0.05|1.81|||Cox proportional hazard regression model|Stratified Cox proportional hazard regression model was utilized.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator's choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.|||1.81|0.05|0.1727
74033365|NCT01763905|147619323|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-3.53|STANDARD_ERROR_OF_MEAN|4.85||0.33|TWO_SIDED|95.0|-13.12|6.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.06|-13.12|0.33
74033366|NCT01763905|147619324|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.67|STANDARD_ERROR_OF_MEAN|4.7||0.97|TWO_SIDED|95.0|-9.96|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||8.61|-9.96|0.97
74033367|NCT01763905|147619324|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|0.08|STANDARD_ERROR_OF_MEAN|5.72||0.33|TWO_SIDED|95.0|-11.24|11.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||11.39|-11.24|0.33
74033368|NCT01763905|147619325|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.9|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-42.26|-31.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-31.55|-42.26|<0.001
74033369|NCT01763905|147619325|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.69|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-43.06|-34.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-34.22|-43.06|<0.001
74033370|NCT01405313|147619326|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|2.5||||0.022|TWO_SIDED|80.0|||||t-test, 1 sided|||||||0.022
74033371|NCT01405313|147619327|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|3.0||||0.016|TWO_SIDED|80.0|||||t-test, 1 sided|||||||0.016
73953834|NCT00848211|147442481|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANOVA|||||||0.008
73953835|NCT00848211|147442483|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
73953836|NCT02444143|147442503|OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
73953837|NCT02444143|147442504|OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.90
73953838|NCT03582137|147442505|SUPERIORITY||Mean Difference (Net)|-1.8049||||0.3785|TWO_SIDED|95.0|-5.8839|2.2741|||Mixed Models Analysis|||||2.2741|-5.8839|0.3785
73953839|NCT03582137|147442509|SUPERIORITY||Mean Difference (Net)|-4.4254||||0.2712|TWO_SIDED|95.0|-12.4018|3.551|||Mixed Models Analysis|||||3.5510|-12.4018|0.2712
73953840|NCT03582137|147442510|SUPERIORITY||Mean Difference (Net)|0.3133||||0.8974|TWO_SIDED|95.0|-4.5414|5.168|||Mixed Models Analysis|||||5.1680|-4.5414|0.8974
73953841|NCT03582137|147442511|SUPERIORITY||Mean Difference (Net)|0.1505||||0.4643|TWO_SIDED|95.0|-0.2882|0.5892|||Mixed Models Analysis|||||0.5892|-0.2882|0.4643
73953842|NCT03582137|147442512|SUPERIORITY||Mean Difference (Net)|-0.1188||||0.6245|TWO_SIDED|95.0|-0.6019|0.3644|||Mixed Models Analysis|||||0.3644|-0.6019|0.6245
73953843|NCT03582137|147442518|SUPERIORITY||Mean Difference (Net)|-0.3341||||0.5921|TWO_SIDED|95.0|-1.5749|0.9068|||Mixed Models Analysis|||||0.9068|-1.5749|0.5921
73953844|NCT03582137|147442519|SUPERIORITY||Mean Difference (Net)|1.9352||||0.1016|TWO_SIDED|95.0|-0.4372|4.3076|||Mixed Models Analysis|||||4.3076|-0.4372|0.1016
73953845|NCT03582137|147442520|SUPERIORITY||Mean Difference (Net)|19.686||||0.0661|TWO_SIDED|95.0|-1.3733|40.7452|||Mixed Models Analysis|||||40.7452|-1.3733|0.0661
74033372|NCT03456713|147619328|OTHER||Ratio of geometric least squares mean|1.47|||||TWO_SIDED|90.0|1.12|1.94||||||||1.94|1.12|
74033373|NCT03456713|147619329|OTHER||Ratio of geometric least squares mean|1.44|||||TWO_SIDED|90.0|1.15|1.81||||||||1.81|1.15|
74033374|NCT03456713|147619330|OTHER||Ratio of geometric least squares mean|1.66|||||TWO_SIDED|90.0|1.31|2.11||||||||2.11|1.31|
74033375|NCT03456713|147619331|SUPERIORITY||Ratio of Geometric Least Squares Means|0.73|||||TWO_SIDED|90.0|0.43|1.23||||||||1.23|0.43|
74033376|NCT03456713|147619332|OTHER||Ratio of geometric least squares mean|0.98|||||TWO_SIDED|90.0|0.58|1.67||||||||1.67|0.58|
74033377|NCT03456713|147619333|OTHER||Ratio of geometric least squares mean|0.7|||||TWO_SIDED|90.0|0.41|1.2||||||||1.20|0.41|
74033378|NCT03848221|147619334|EQUIVALENCE|||||||0.3|||||||ANOVA|||||||0.30
74033379|NCT03848221|147619335|EQUIVALENCE|||||||0.0002|||||||ANOVA|||||||0.0002
74033380|NCT01071044|147619399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||ANOVA|These data were initially analyzed with a one-way ANOVA.||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||.005
74033381|NCT01071044|147619400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED|95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.008
74033382|NCT01071044|147619401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.183
74033383|NCT01071044|147619402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.046
74033384|NCT01071044|147619403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.219
74033385|NCT01071044|147619404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.038
73873529|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73953846|NCT03582137|147442521|SUPERIORITY||Mean Difference (Net)|-3.2214||||0.088|TWO_SIDED|95.0|-6.9381|0.4953|||Mixed Models Analysis|||||0.4953|-6.9381|0.0880
73953847|NCT03582137|147442522|SUPERIORITY||Mean Difference (Net)|-4.9836||||0.2827|TWO_SIDED|95.0|-14.2093|4.2421|||Mixed Models Analysis|||||4.2421|-14.2093|0.2827
73953848|NCT03582137|147442523|SUPERIORITY||Mean Difference (Net)|0.576||||0.7703|TWO_SIDED|95.0|-3.3697|4.5216|||Mixed Models Analysis|||||4.5216|-3.3697|0.7703
73953849|NCT03582137|147442524|SUPERIORITY||Mean Difference (Net)|-0.8834||||0.1874|TWO_SIDED|95.0|-2.2172|0.4504|||Mixed Models Analysis|||||0.4504|-2.2172|0.1874
73953850|NCT03582137|147442527|SUPERIORITY||Mean Difference (Net)|1.2993||||0.1646|TWO_SIDED|95.0|-0.5533|3.1519|||Mixed Models Analysis|||||3.1519|-0.5533|0.1646
73953851|NCT03582137|147442528|SUPERIORITY||Mean Difference (Net)|-1.7519||||0.1093|TWO_SIDED|95.0|-3.9082|0.4045|||Mixed Models Analysis|||||0.4045|-3.9082|0.1093
73953852|NCT03582137|147442529|SUPERIORITY||Mean Difference (Net)|1.3532||||0.1819|TWO_SIDED|95.0|-0.6511|3.3576|||Mixed Models Analysis|||||3.3576|-0.6511|0.1819
73953853|NCT03582137|147442530|SUPERIORITY||Mean Difference (Net)|0.9667||||0.2282|TWO_SIDED|95.0|-0.6287|2.5621|||Mixed Models Analysis|||||2.5621|-0.6287|0.2282
73953854|NCT03582137|147442531|SUPERIORITY||Mean Difference (Net)|-0.2614||||0.6167|TWO_SIDED|95.0|-1.3002|0.7775|||Mixed Models Analysis|||||0.7775|-1.3002|0.6167
73953855|NCT03582137|147442532|SUPERIORITY||Mean Difference (Net)|0.3067||||0.8378|TWO_SIDED|95.0|-2.6765|3.2899|||Mixed Models Analysis|||||3.2899|-2.6765|0.8378
73981022|NCT02291861|147507450|SUPERIORITY||Odds Ratio (OR)|0.69||||0.372|TWO_SIDED|95.0|0.302|1.563||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||1.563|0.302|0.372
73953856|NCT03582137|147442534|SUPERIORITY||Mean Difference (Net)|0.3237||||0.2103|TWO_SIDED|95.0|-0.188|0.8353|||Mixed Models Analysis|||||0.8353|-0.1880|0.2103
73953857|NCT03582137|147442535|SUPERIORITY||Mean Difference (Net)|-0.504||||0.7197|TWO_SIDED|95.0|-3.3015|2.2934|||Mixed Models Analysis|||||2.2934|-3.3015|0.7197
73953858|NCT03582137|147442536|SUPERIORITY||Mean Difference (Net)|2.6158||||0.0686|TWO_SIDED|95.0|-0.2058|5.4373|||Mixed Models Analysis|||||5.4373|-0.2058|0.0686
73953859|NCT03582137|147442537|SUPERIORITY||Mean Difference (Net)|2.7891||||0.2339|TWO_SIDED|95.0|-1.8523|7.4304|||Mixed Models Analysis|||||7.4304|-1.8523|0.2339
73953860|NCT03582137|147442538|SUPERIORITY||Mean Difference (Net)|0.9536||||0.7557|TWO_SIDED|95.0|-5.1655|7.0727|||Mixed Models Analysis|||||7.0727|-5.1655|0.7557
73953861|NCT03582137|147442540|SUPERIORITY||Mean Difference (Net)|0.05126||||0.915|TWO_SIDED|95.0|-0.9086|1.0111|||Mixed Models Analysis|||||1.0111|-0.9086|0.9150
73953862|NCT03582137|147442541|SUPERIORITY||Mean Difference (Net)|-0.6699||||0.6164|TWO_SIDED|95.0|-3.3316|1.9918|||Mixed Models Analysis|||||1.9918|-3.3316|0.6164
73953863|NCT03582137|147442542|SUPERIORITY||Mean Difference (Net)|-0.1358||||0.755|TWO_SIDED|95.0|-1.0028|0.7312|||Mixed Models Analysis|||||0.7312|-1.0028|0.7550
73953864|NCT03582137|147442543|SUPERIORITY||Mean Difference (Net)|-0.09605||||0.9016|TWO_SIDED|95.0|-1.6449|1.4528|||Mixed Models Analysis|||||1.4528|-1.6449|0.9016
73953865|NCT03582137|147442544|SUPERIORITY||Mean Difference (Net)|-0.3217||||0.9219|TWO_SIDED|95.0|-6.8584|6.2151|||Mixed Models Analysis|||||6.2151|-6.8584|0.9219
73953866|NCT03582137|147442545|SUPERIORITY||Mean Difference (Net)|0.02897||||0.3178|TWO_SIDED|95.0|-0.02857|0.08651|||Mixed Models Analysis|||||0.08651|-0.02857|0.3178
74089539|NCT05626803|147731754|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
73953867|NCT03582137|147442550|SUPERIORITY||Mean Difference (Net)|0.2288||||0.7693|TWO_SIDED|95.0|-1.325|1.7825|||Mixed Models Analysis|||||1.7825|-1.3250|0.7693
73953868|NCT03582137|147442551|SUPERIORITY||Mean Difference (Net)|-0.8121||||0.5285|TWO_SIDED|95.0|-3.3743|1.7501|||Mixed Models Analysis|||||1.7501|-3.3743|0.5285
73953869|NCT03582137|147442552|SUPERIORITY||Mean Difference (Net)|-0.02525||||0.9463|TWO_SIDED|95.0|-0.7717|0.7212|||Mixed Models Analysis|||||0.7212|-0.7717|0.9463
73953870|NCT03582137|147442553|SUPERIORITY||Mean Difference (Net)|-0.3042||||0.4362|TWO_SIDED|95.0|-1.0817|0.4732|||Mixed Models Analysis|||||0.4732|-1.0817|0.4362
73953871|NCT03582137|147442554|SUPERIORITY||Mean Difference (Net)|-0.06489||||0.9327|TWO_SIDED|95.0|-1.5957|1.4659|||Mixed Models Analysis|||||1.4659|-1.5957|0.9327
73953872|NCT03582137|147442557|SUPERIORITY||Mean Difference (Net)|-0.2763||||0.4401|TWO_SIDED|95.0|-0.988|0.4354|||Mixed Models Analysis|||||0.4354|-0.9880|0.4401
73953873|NCT03582137|147442558|SUPERIORITY||Mean Difference (Net)|-0.8319||||0.8085|TWO_SIDED|95.0|-7.6835|6.0197|||Mixed Models Analysis|||||6.0197|-7.6835|0.8085
73953874|NCT03582137|147442560|SUPERIORITY||Mean Difference (Net)|0.02673||||0.9674|TWO_SIDED|95.0|-1.2757|1.3292|||Mixed Models Analysis|||||1.3292|-1.2757|0.9674
73953875|NCT03582137|147442562|SUPERIORITY||Mean Difference (Net)|-46.92||||0.1128|TWO_SIDED|95.0|-105.51|11.68|||Mixed Models Analysis|||||11.68|-105.51|0.1128
73953876|NCT00483262|147442573|SUPERIORITY_OR_OTHER||>= grade 3 adverse event proportion|0.9|||||TWO_SIDED|90.0|0.72|0.98|||||Estimated proportion of patients with a adverse event of grade 3 or higher.|Single Arm Study||.98|.72|
73953877|NCT00483262|147442573|SUPERIORITY_OR_OTHER||toxicity grade >=3 proportion|0.79|||||TWO_SIDED|90.0|0.66|0.89|||||No comparison. Estimate the proportion of patients with grade 3 or higher toxicity.|Phase II toxicity||.89|.66|
73953878|NCT00483262|147442574|SUPERIORITY_OR_OTHER||response rate of PR or better|0.1|||||TWO_SIDED|90.0|0.02|0.28|||||Response of PR or better|Phase I part of this phase I/II study||.28|.02|
73953879|NCT00483262|147442574|SUPERIORITY_OR_OTHER||response rate of PR or better|0.33|||||TWO_SIDED|90.0|0.21|0.47|||||Response of PR or better|Phase II part of this phase I/II study.||0.47|0.21|
73953880|NCT02303574|147442590|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.287|STANDARD_ERROR_OF_MEAN|0.05085|||TWO_SIDED|95.0|1.183|1.391||||||||1.391|1.183|
73953881|NCT02303574|147442590|OTHER|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|90.72|||||TWO_SIDED|90.0|83.72|98.31||||||||98.31|83.72|
73953882|NCT02303574|147442591|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||TWO_SIDED|90.0|140.61|180.7||||||||180.70|140.61|
73873530|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
73873531|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73873532|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873533|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873534|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
73953883|NCT02303574|147442591|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||TWO_SIDED|90.0|138.23|166.74||||||||166.74|138.23|
73953884|NCT02303574|147442591|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||TWO_SIDED|90.0|146.67|171.67||||||||171.67|146.67|
73953885|NCT02303574|147442592|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.228|STANDARD_ERROR_OF_MEAN|0.1329|||TWO_SIDED|95.0|0.9513|1.504||||||||1.504|0.9513|
73873535|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73981023|NCT02291861|147507451|SUPERIORITY||Odds Ratio (OR)|3.8||||0.007|TWO_SIDED|95.0|1.395|10.359||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||10.359|1.395|0.007
73873536|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73873537|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
73873538|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
73873539|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73953886|NCT02303574|147442592|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||TWO_SIDED|90.0|140.61|180.7||||||||180.70|140.61|
73953887|NCT02303574|147442592|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||TWO_SIDED|90.0|138.23|166.74||||||||166.74|138.23|
73953888|NCT02303574|147442592|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||TWO_SIDED|90.0|146.67|171.67||||||||171.67|146.67|
73873540|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873541|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873542|NCT01128426|147289447|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73873543|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .63
73873544|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
73873545|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873546|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.6|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.60
74089540|NCT05626803|147731754|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
73873547|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
73873548|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873549|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73873550|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73953889|NCT02303574|147442593|OTHER||Slope|1.302|STANDARD_ERROR_OF_MEAN|0.05056|||TWO_SIDED|95.0|1.198|1.406||||||Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.||1.406|1.198|
73953890|NCT02303574|147442593|OTHER|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|64.14|||||TWO_SIDED|90.0|55.07|74.7||||||||74.70|55.07|
73873551|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873552|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
73953891|NCT02303574|147442594|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.157|STANDARD_ERROR_OF_MEAN|0.1098|||TWO_SIDED|95.0|0.9285|1.385||||||||1.385|0.9285|
73953892|NCT00783718|147442646|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.7|||<|0.0001|TWO_SIDED|95.0|11.6|31.7|||Cochran-Mantel-Haenszel|||The primary comparison of the Induction Phase was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level, with stratification according to the stratification factors (concomitant use of oral corticosteroids and previous exposure to tumor necrosis factor alpha (TNFα) antagonists or concomitant immunomodulator \[6-mercaptopurine or azathioprine\] use).||31.7|11.6|< 0.0001
73953893|NCT00783718|147442647|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.1|||<|0.0001|TWO_SIDED|95.0|14.9|37.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||37.2|14.9|< 0.0001
73981024|NCT02291861|147507451|SUPERIORITY||Odds Ratio (OR)|3.96||||0.005|TWO_SIDED|95.0|1.46|10.716||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||10.716|1.460|0.005
73981025|NCT02291861|147507451|SUPERIORITY||Odds Ratio (OR)|1.13||||0.829|TWO_SIDED|95.0|0.383|3.316||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.316|0.383|0.829
73981026|NCT02291861|147507452|SUPERIORITY||Mean Difference (Final Values)|-21.5|||<|0.001|TWO_SIDED|95.0|-33.44|-9.52||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||-9.52|-33.44|<0.001
73873553|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
73873554|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873555|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
73873556|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873557|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
73873558|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
73873559|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
73953894|NCT00783718|147442647|SUPERIORITY_OR_OTHER||Risk Difference (RD)|29.1|||<|0.0001|TWO_SIDED|95.0|17.9|40.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||40.4|17.9|< 0.0001
73953895|NCT00783718|147442648|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.5||||0.0009|TWO_SIDED|95.0|4.7|18.3||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.||18.3|4.7|0.0009
73953896|NCT00783718|147442649|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.1||||0.0012||95.0|6.4|25.9||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.||25.9|6.4|0.0012
73953897|NCT00783718|147442650|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.8|||<|0.0001|TWO_SIDED|95.0|20.8|44.7||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||44.7|20.8|< 0.0001
73873560|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
73981027|NCT02291861|147507452|SUPERIORITY||Mean Difference (Final Values)|-20.2||||0.001|TWO_SIDED|95.0|-32.57|-7.92||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||-7.92|-32.57|0.001
74089541|NCT05626803|147731754|SUPERIORITY|||||||0.0003|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0003
73873561|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
74089542|NCT05626803|147731756|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
74089543|NCT05626803|147731756|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
74089544|NCT05626803|147731756|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
73873562|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
73873563|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.75|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.75
73873564|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73873565|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873566|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873567|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873568|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
74089545|NCT05626803|147731758|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
74089546|NCT05626803|147731758|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
74089547|NCT05626803|147731758|SUPERIORITY|||||||0.0017|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0017
73873569|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
73981028|NCT02291861|147507452|SUPERIORITY||Mean Difference (Final Values)|-8.4||||0.16|TWO_SIDED|95.0|-20.15|3.34||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||3.34|-20.15|0.160
73981029|NCT03845517|147507470|SUPERIORITY||Risk Difference (RD)|-7.5||||0.8076|TWO_SIDED|95.0|-24.5|9.5||One sided p-value.|Cochran-Mantel-Haenszel|||||9.5|-24.5|0.8076
73981030|NCT03845517|147507470|SUPERIORITY||Risk Difference (RD)|5.2||||0.2189|TWO_SIDED|95.0|-7.9|18.3||One sided p-value.|Cochran-Mantel-Haenszel|||||18.3|-7.9|0.2189
73981031|NCT03845517|147507470|SUPERIORITY||Risk Difference (RD)|1.7||||0.401|TWO_SIDED|95.0|-11.8|15.3||One sided p-value.|Cochran-Mantel-Haenszel|||||15.3|-11.8|0.4010
73981032|NCT03845517|147507471|SUPERIORITY||Risk Difference (RD)|-2.1||||0.595|TWO_SIDED|95.0|-19.1|14.9||One sided p-value.|Cochran-Mantel-Haenszel|||||14.9|-19.1|0.5950
73981033|NCT03845517|147507471|SUPERIORITY||Risk Difference (RD)|8.6||||0.1125|TWO_SIDED|95.0|-5.3|22.6||One sided p-value.|Cochran-Mantel-Haenszel|||||22.6|-5.3|0.1125
73981034|NCT03845517|147507471|SUPERIORITY||Risk Difference (RD)|9.6||||0.0891|TWO_SIDED|95.0|-4.4|23.6||One sided p-value.|Cochran-Mantel-Haenszel|||||23.6|-4.4|0.0891
73981035|NCT02410278|147507499|SUPERIORITY||Odds Ratio (OR)|3.931||||0.0617|TWO_SIDED|95.0|0.938|20.832|||weighted logistic regression model|||Odds ratio is the odds of an event in the Montelukast treatment group divided by the odds of an event in the placebo treatment group. P-value is from the likelihood ratio test that the odds ratio is 1. CI = profile likelihood confidence interval.||20.832|0.938|0.0617
73981036|NCT02410278|147507500|SUPERIORITY||adjusted mean difference|0.084||||0.3753|TWO_SIDED|95.0|-0.104|0.273|||ANCOVA|||Results are obtained from an ANCOVA model for comparing average change of the GSRS score in the two treatment groups, adjusted for age, weight and baseline GSRS score. Weights, defined as the proportions of days with GSRS score recorded during the Day 1 - Day 10 period are applied to adjust for missing data.||0.273|-0.104|0.3753
73981037|NCT02410278|147507501|SUPERIORITY||adjusted mean difference|0.081||||0.0376|TWO_SIDED|95.0|0.005|0.158|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Week 10.||0.158|0.005|0.0376
73981038|NCT02410278|147507502|SUPERIORITY||Hazard Ratio (HR)|1.094||||0.7952|TWO_SIDED|95.0|0.554|2.164|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.||2.164|0.554|0.7952
73981039|NCT02410278|147507503|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.8328|TWO_SIDED|95.0|0.563|1.589|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.||1.589|0.563|0.8328
73981040|NCT02410278|147507504|SUPERIORITY||adjusted mean difference|0.115||||0.1743|TWO_SIDED|95.0|-0.052|0.283|||Repeated measures model|||Change from Day 1 to Week 1: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.283|-0.052|0.1743
73981041|NCT02410278|147507504|SUPERIORITY||adjusted mean difference|0.079||||0.2677|TWO_SIDED|95.0|-0.063|0.221|||Repeated measures model|||Change from Day 1 to Week 2: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.221|-0.063|0.2677
73981042|NCT02410278|147507504|SUPERIORITY||adjusted mean difference|0.085||||0.1788|TWO_SIDED|95.0|-0.04|0.211|||Repeated measures model|||Change from Day 1 to Week 3: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.211|-0.040|0.1788
74089548|NCT05626803|147731760|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
74089549|NCT05626803|147731760|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
73981043|NCT02410278|147507504|SUPERIORITY||adjusted mean difference|0.1||||0.0866|TWO_SIDED|95.0|-0.015|0.216|||Repeated measures model|||Change from Day 1 to Week 4: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.216|-0.015|0.0866
73981044|NCT02410278|147507504|SUPERIORITY||adjusted mean difference|0.1||||0.0509|TWO_SIDED|95.0|0.0|0.201|||Repeated measures model|||Change from Day 1 to Week 5: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.201|-0.000|0.0509
73873570|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73981045|NCT02410278|147507504|SUPERIORITY||adjusted mean difference|0.088||||0.0649|TWO_SIDED|95.0|-0.006|0.182|||Repeated measures model|||Change from Day 1 to Week 6: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.182|-0.006|0.0649
73981046|NCT02410278|147507504|SUPERIORITY||adjusted mean difference|0.088||||0.0479|TWO_SIDED|95.0|0.001|0.176|||Repeated measures model|||Change from Day 1 to Week 7: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.176|0.001|0.0479
73981047|NCT02410278|147507504|SUPERIORITY||adjusted mean difference|0.082||||0.054|TWO_SIDED|95.0|-0.001|0.166|||Repeated measures model|||Change from Day 1 to Week 8: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.166|-0.001|0.0540
73981048|NCT02410278|147507505|SUPERIORITY||adjusted mean difference|0.129||||0.2469|TWO_SIDED|95.0|-0.092|0.349|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight (kg) and baseline GSRS score, and has unstructured variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Day 3.||0.349|-0.092|0.2469
73981049|NCT02410278|147507506|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
73981050|NCT02410278|147507507|SUPERIORITY|||||||1|||||||Fisher's Exact|||||||1.0000
73981051|NCT02410278|147507508|SUPERIORITY|||||||0.2604|||||||Chi-squared|||||||0.2604
73981052|NCT02584257|147507515|SUPERIORITY||Least Square Means Differences|3.171|STANDARD_ERROR_OF_MEAN|0.238|<|0.0001|TWO_SIDED|95.0|2.732|3.61||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||3.610|2.732|<0.0001
73981053|NCT02584257|147507515|SUPERIORITY||Least Square Means Differences|3.824|STANDARD_ERROR_OF_MEAN|0.238|<|0.0001|TWO_SIDED|95.0|3.384|4.263||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||4.263|3.384|<0.0001
73981054|NCT02584257|147507515|SUPERIORITY||Least Square Means Differences|3.32|STANDARD_ERROR_OF_MEAN|0.241|<|0.0001|TWO_SIDED|95.0|2.876|3.764||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL.||||3.764|2.876|<0.0001
73981055|NCT02584257|147507515|SUPERIORITY||Least Square Means Differences|3.872|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|3.43|4.315||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||4.315|3.430|<0.0001
73981056|NCT02584257|147507515|EQUIVALENCE|A blinded interim analysis was performed after 60 patients completed all treatment visits which determined that 80 subjects would be sufficient to complete the study with 90% power.|Frel|1.15|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.93|1.48|||||Frel is the relative bioavailability of the test versus reference product. The CI was a bias corrected and accelerated CI based on a bootstrapping procedure. The FDA acceptable CI was between 0.67 and 1.50.|An Emax model was developed and the 90% confidence interval of Frel was a bias corrected accelerated confidence interval based on a bootstrapping procedure. The bootstrapping procedure used for this analysis was residual resampling. The Per-Protocol population was the primary population for bioequivalence analysis. Patients in the PP population must have completed at least 2 treatment periods with valid PC20FEV1 measurements and had no major protocol deviations within those intervals.||1.48|0.93|
73981057|NCT00257309|147507538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.21|TWO_SIDED|95.0|0.38|1.23||Unadjusted analysis|Chi-squared|||||1.23|0.38|0.21
73981058|NCT02841449|147507544|OTHER|||||||0.886|||||||t-test, 2 sided|paired sample||||||0.886
73981059|NCT02841449|147507544|OTHER|||||||0.43||||||The above is the trial\*time interaction. trial, p = 0.627; time, p \< 0.001|ANOVA|repeated measures||||||0.430
73981060|NCT02841449|147507545|OTHER|||||||0.369|||||||t-test, 2 sided|paired samples||||||0.369
73981061|NCT02841449|147507545|OTHER|||||||0.859||||||The above is the trial\*time interaction. trial p = 0.200; time p \< 0.001|ANOVA|repeated measures||||||0.859
73981062|NCT02841449|147507546|OTHER||||||<|0.001|||||||t-test, 2 sided|paired samples||||||<0.001
73981063|NCT02841449|147507546|OTHER|||||||0.261||||||The above is the trial\*time interaction. trial p = 0.002; time p = 0.282|ANOVA|repeated measures||||||0.261
73981064|NCT02841449|147507547|OTHER|||||||0.736|||||||t-test, 2 sided|paired samples||||||0.736
73981065|NCT02841449|147507548|OTHER|||||||0.542|||||||t-test, 2 sided|paired samples||||||0.542
74033386|NCT01071044|147619405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.022
73953898|NCT00783718|147442650|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.5|||<|0.0001|TWO_SIDED|95.0|16.7|40.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||40.3|16.7|< 0.0001
73953899|NCT00783718|147442651|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.0|||<|0.0001|TWO_SIDED|95.0|20.3|43.8||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||43.8|20.3|< 0.0001
73981066|NCT02841449|147507549|OTHER|||||||0.4|||||||t-test, 2 sided|paired samples||||||0.400
73981067|NCT02841449|147507550|OTHER|||||||0.646|||||||ANOVA|repeated measures||Visual analogue scale for thirst||||0.646
73981068|NCT02841449|147507550|OTHER|||||||0.403|||||||ANOVA|repeated measures||visual analogue scale for desire for savoury||||0.403
73981069|NCT02841449|147507550|OTHER|||||||0.022|||||||ANOVA|repeated measures||visual analogue scale for desire for salt||||0.022
73981070|NCT02841449|147507550|OTHER|||||||0.849|||||||ANOVA|repeated measures||visual analogue scale for hunger||||0.849
73981071|NCT02841449|147507550|OTHER|||||||0.062|||||||ANOVA|repeated measures||visual analogue scale for fullness||||0.062
73981072|NCT02841449|147507550|OTHER|||||||0.549|||||||ANOVA|repeated measures||visual analogue scale for how much participants felt they could eat||||0.549
73981073|NCT02841449|147507550|OTHER|||||||0.402|||||||ANOVA|repeated measures||visual analogue scale for sweet desire||||0.402
73981074|NCT02841449|147507550|OTHER|||||||0.138|||||||ANOVA|repeated measures||visual analogue scale for fatty food desire||||0.138
73981075|NCT02841449|147507551|OTHER|||||||0.055||||||Above is trial\*time effect. trial p = 0.135; time p = 0.011|ANOVA|repeated measures||||||0.055
73981076|NCT02841449|147507552|OTHER|||||||0.226|||||||t-test, 2 sided|paired sample||||||0.226
73981077|NCT02841449|147507553|OTHER||||||<|0.001|||||||t-test, 2 sided|paired samples||||||< 0.001
73981078|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|4.1|||||TWO_SIDED|95.0|-0.9|9.2||||||Tx 1 - SBP (Unadjusted)||9.2|-0.9|
73981079|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.4|5.3||||||Tx 1 - DBP (Unadjusted)||5.3|-0.4|
73981080|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-6.2|5.6||||||Wk 3 - SBP (Unadjusted)||5.6|-6.2|
73981081|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-4.0|3.5||||||Wk 3 - DBP (Unadjusted)||3.5|-4.0|
73981082|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-1.9|8.9||||||Wk 6 - SBP (Unadjusted)||8.9|-1.9|
73981083|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-2.1|5.0||||||Wk 6 - DBP (Unadjusted)||5.0|-2.1|
73981084|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|4.7|||||TWO_SIDED|95.0|-0.4|9.8||||||Tx 1 - SBP (Adjusted)||9.8|-0.4|
73981085|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|3.6|||||TWO_SIDED|95.0|0.6|6.5||||||Tx 1 - DBP (Adjusted)||6.5|0.6|
73981086|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-5.0|6.9||||||Wk 3 - SBP (Adjusted)||6.9|-5.0|
73981087|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9||||||Wk 3 - DBP (Adjusted)||4.9|-2.8|
73981088|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-0.4|10.0||||||Wk 6 - SBP (Adjusted)||10.0|-0.4|
73981089|NCT01020435|147507558|OTHER||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|-1.2|5.8||||||Wk 6 - DBP (Adjusted)||5.8|-1.2|
73981090|NCT00346398|147507588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.28|TWO_SIDED|95.0|0.5|10.5||Odds Ratios are calculated using a logistic regression with a Wald chi square test. Experimental group participants had a higher proportion of allergic sensitization than participants who received placebo|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.||10.5|0.5|0.28
73981091|NCT00346398|147507589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.85|TWO_SIDED|95.0|0.2|6.1||Odds Ratios are calculated using unadjusted exact logistic regression with mid p-value to adjust for the discreteness of the distribution|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.||6.1|0.2|0.85
73981092|NCT00346398|147507590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.28|TWO_SIDED|95.0|0.6|5.6||P-value is calculated using a log-rank test|Regression, Logistic||Hazard ratio and 95% confidence intervals are calculated using an unadjusted Cox regression|||5.6|0.6|0.28
73953900|NCT00783718|147442651|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.3|||<|0.0001|TWO_SIDED|95.0|24.4|48.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||48.3|24.4|< 0.0001
73953901|NCT00783718|147442652|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.8||||0.0079|TWO_SIDED|95.0|3.1|20.5||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||20.5|3.1|0.0079
73981093|NCT02607956|147507591|NON_INFERIORITY|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-3.5|||||TWO_SIDED|95.002|-7.9|1.0|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||1.0|-7.9|
73981094|NCT02607956|147507591|SUPERIORITY|||||||0.12|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.12
73981095|NCT02607956|147507592|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-7.9|3.2|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.2|-7.9|
73981096|NCT02607956|147507592|OTHER|||||||0.41|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.41
73981097|NCT02607956|147507593|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-7.8|3.9|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.9|-7.8|
73873571|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73953902|NCT00783718|147442652|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.3||||0.0009|TWO_SIDED|95.0|6.2|24.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||24.4|6.2|0.0009
73981098|NCT02607956|147507593|OTHER|||||||0.52|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.52
73981099|NCT02607956|147507594|OTHER||Difference in Percentages|-3.9|||||TWO_SIDED|95.0|-9.4|1.5|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||1.5|-9.4|
73981100|NCT02607956|147507594|OTHER|||||||0.16|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.16
73981101|NCT02607956|147507595|OTHER||Difference in Percentages|-2.5|||||TWO_SIDED|95.0|-8.8|3.8|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.8|-8.8|
73981102|NCT02607956|147507595|OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.44
73981103|NCT02607956|147507596|OTHER||Difference in Percentages|-1.1|||||TWO_SIDED|95.0|-7.4|5.3|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||5.3|-7.4|
74089550|NCT05626803|147731760|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
74089551|NCT05626803|147731762|SUPERIORITY|||||||0.0059|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0059
73873572|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
73873573|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
73873574|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.84|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.84
73873575|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.44|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.44
73953903|NCT00783718|147442653|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.6||||0.012|TWO_SIDED|95.0|3.9|31.3||P-value based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||31.3|3.9|0.0120
73953904|NCT00783718|147442653|SUPERIORITY_OR_OTHER||Risk Difference (RD)|31.4|||<|0.0001|TWO_SIDED|95.0|16.6|46.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||46.2|16.6|< 0.0001
73953905|NCT01027871|147442656|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.17||||0.433|TWO_SIDED|90.0|-0.18|0.52||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.52|-0.18|0.433
73953906|NCT01027871|147442657|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.2||||0.388|TWO_SIDED|90.0|-0.59|0.19||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.59|0.388
73953907|NCT01027871|147442658|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.09||||0.197|TWO_SIDED|90.0|-0.21|0.03||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.03|-0.21|0.197
73953908|NCT01027871|147442659|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%"|Fisher Exact|||||||0.609
73953909|NCT01027871|147442659|SUPERIORITY_OR_OTHER|||||||0.314||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%"|Fisher Exact|||||||0.314
73953910|NCT01027871|147442660|SUPERIORITY_OR_OTHER|||||||0.375||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.375
73953911|NCT01027871|147442660|SUPERIORITY_OR_OTHER|||||||0.811||95.0||||"The statistical significance level is 0.10.~P- value is for HbA1c ≤6.5%"|Fisher Exact|||||||0.811
73953912|NCT01027871|147442661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.43||||0.144|TWO_SIDED|90.0|-0.92|0.05||"The statistical significance level is 0.10.~P- value is for morning 2-hr postprandial BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.05|-0.92|0.144
73953913|NCT01027871|147442661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.25||||0.36|TWO_SIDED|90.0|-0.7|0.2||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.20|-0.70|0.360
73953914|NCT01027871|147442661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.26||||0.342|TWO_SIDED|90.0|-0.72|0.19||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.72|0.342
73953915|NCT01027871|147442661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.12||||0.654|TWO_SIDED|90.0|-0.56|0.32||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.32|-0.56|0.654
73953916|NCT01027871|147442661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.25||||0.387|TWO_SIDED|90.0|-0.73|0.23||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.23|-0.73|0.387
73873576|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873577|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
73873578|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73873579|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873580|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
74033387|NCT01201798|147619413|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was 0.5 units, meaning that the upper limit of the two-tailed 95% confidence interval must have been less than 0.5 to establish noninferiority.|Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||A two-tailed 95% confidence interval was calculated for the difference in change from baseline in anterior chamber cell grade at Day 14 (difluprednate minus prednisolone). The confidence interval was derived from an analysis of covariance (ANCOVA), with investigative site included as a fixed effect to match the stratification used in the randomization process. Treatment and baseline anterior chamber cell grade were also included as fixed effects.||0.09|-0.53|
74089552|NCT05626803|147731762|SUPERIORITY|||||||0.002|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0020
74089553|NCT05626803|147731762|SUPERIORITY|||||||0.1899|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.1899
74089554|NCT05626803|147731764|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
73953917|NCT01027871|147442661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.29||||0.339|TWO_SIDED|90.0|-0.79|0.21||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.21|-0.79|0.339
73953918|NCT01027871|147442661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.1||||0.676|TWO_SIDED|90.0|-0.3|0.5||"The statistical significance level is 0.10.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.50|-0.30|0.676
73953919|NCT01027871|147442663|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||The statistical significance level is 0.10.|Fisher Exact|||||||0.162
73953920|NCT01027871|147442664|SUPERIORITY_OR_OTHER|||||||0.804||95.0||||The statistical significance level is 0.10.|Negative Binomial Model|||||||0.804
73953921|NCT01027871|147442666|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.937||90.0|-0.16|0.14||"The statistical significance level is 0.10.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.14|-0.16|0.937
73953922|NCT01027871|147442666|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.03||||0.687|TWO_SIDED|90.0|-0.16|0.1||"The statistical significance level is 0.10.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.10|-0.16|0.687
73953923|NCT01027871|147442668|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.4||||0.159|TWO_SIDED|90.0|-0.87|0.07||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.07|-0.87|0.159
73953924|NCT01027871|147442668|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.17||||0.542|TWO_SIDED|90.0|-0.62|0.29||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.29|-0.62|0.542
73953925|NCT01027871|147442669|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.88|TWO_SIDED|90.0|-0.16|0.13||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.13|-0.16|0.880
73953926|NCT01027871|147442669|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.17||||0.045|TWO_SIDED|90.0|-0.32|-0.03||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.03|-0.32|0.045
73953927|NCT01027871|147442670|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.273
73953928|NCT01027871|147442670|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.287
73953929|NCT01027871|147442670|SUPERIORITY_OR_OTHER|||||||0.879||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.879
73953930|NCT01027871|147442670|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.722
73953931|NCT01027871|147442671|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.139
73953932|NCT01027871|147442671|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.569
73953933|NCT01027871|147442671|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.515
73953934|NCT01027871|147442671|SUPERIORITY_OR_OTHER|||||||1||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||1.000
73953935|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.26||||0.305|TWO_SIDED|90.0|-0.16|0.67||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.67|-0.16|0.305
74089555|NCT05626803|147731764|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
73873581|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73873582|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873583|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
73873584|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
73953936|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.14||||0.571|TWO_SIDED|90.0|-0.54|0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.26|-0.54|0.571
73953937|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.26||||0.454||90.0|-0.85|0.32||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.32|-0.85|0.454
74089556|NCT05626803|147731764|SUPERIORITY|||||||0.002|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0020
73873585|NCT01128426|147289448|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
73953938|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.83||||0.016|TWO_SIDED|90.0|-1.4|-0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.26|-1.40|0.016
73953939|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.07||||0.838||90.0|-0.61|0.48||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.48|-0.61|0.838
73953940|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.69||||0.033|TWO_SIDED|90.0|-1.22|-0.16||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.16|-1.22|0.033
73953941|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.4||||0.229|TWO_SIDED|90.0|-0.95|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.15|-0.95|0.229
73953942|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.27||||0.412|TWO_SIDED|90.0|-0.8|0.27||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.27|-0.80|0.412
73953943|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.15||||0.642|TWO_SIDED|90.0|-0.68|0.38||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.38|-0.68|0.642
74089557|NCT03861481|147731783|SUPERIORITY||LS Mean difference (Rozimab - Placebo)|-0.052|||||TWO_SIDED|90.0|-0.892|0.788|||||MMRM analysis (fixed effect terms: treatment, baseline iRODS score, prior Ig therapy administration route, assessment week, treatment by week interaction; random effect term: study participant). LS Mean Difference \> 0 favours rozanolixizumab.|||0.788|-0.892|
73873586|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
74089558|NCT00773734|147731784|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.6||||0.1846|TWO_SIDED|95.0|-2.6|13.7|||Chi-squared|||||13.7|-2.6|0.1846
74089559|NCT00773734|147731784|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|23.1|||<|0.0001|TWO_SIDED|95.0|12.4|33.7|||Chi-squared|||||33.7|12.4|<0.0001
73873587|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
73873588|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873589|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.55|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.55
73873590|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873591|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
73873592|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73953944|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.16||||0.614|TWO_SIDED|90.0|-0.67|0.36||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.36|-0.67|0.614
73953945|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.5||||0.147|TWO_SIDED|90.0|-1.07|0.07||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.07|-1.07|0.147
73953946|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.42||||0.21|TWO_SIDED|90.0|-0.98|0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.13|-0.98|0.210
73953947|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.28||||0.438|TWO_SIDED|90.0|-0.86|0.31||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.31|-0.86|0.438
73953948|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.7||||0.043|TWO_SIDED|90.0|-1.28|-0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.13|-1.28|0.043
73953949|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.24||||0.403|TWO_SIDED|90.0|-0.23|0.72||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.72|-0.23|0.403
73953950|NCT01027871|147442672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.29||||0.314|TWO_SIDED|90.0|-0.75|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.18|-0.75|0.314
73953951|NCT01027871|147442674|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact|||||||0.046
73953952|NCT01027871|147442674|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact|||||||0.224
73953953|NCT01027871|147442675|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model|||||||0.561
73953954|NCT01027871|147442675|SUPERIORITY_OR_OTHER|||||||0.518||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model|||||||0.518
73953955|NCT01027871|147442676|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.938|TWO_SIDED|90.0|-0.2|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.18|-0.20|0.938
73953956|NCT01027871|147442676|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.0||||0.972|TWO_SIDED|90.0|-0.18|0.19||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.18|0.972
73953957|NCT01027871|147442676|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.927|TWO_SIDED|90.0|-0.16|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.15|-0.16|0.927
73953958|NCT01027871|147442676|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.1||||0.293|TWO_SIDED|90.0|-0.25|0.05||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.05|-0.25|0.293
73953959|NCT02084082|147442695|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|100.37|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|96.562|104.326|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||104.326|96.562|<0.0001
73953960|NCT02084082|147442695|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio (net)|94.7|STANDARD_ERROR_OF_MEAN|1.037||0.0004|TWO_SIDED|90.0|88.712|101.089|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000 Fed/ L+M 1000 Fed)|||101.089|88.712|0.0004
73953961|NCT02084082|147442696|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|108.09|STANDARD_ERROR_OF_MEAN|1.054||0.0038|TWO_SIDED|90.0|99.022|117.989|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||117.989|99.022|0.0038
74089560|NCT00773734|147731784|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.2|||<|0.0001|TWO_SIDED|95.0|23.9|46.6|||Chi-squared|||||46.6|23.9|<0.0001
73873593|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73953962|NCT02084082|147442696|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.24|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.067|102.597|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||102.597|94.067|<0.0001
73953963|NCT02084082|147442697|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|99.99|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|93.03|107.47|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||107.47|93.03|<0.0001
73953964|NCT02084082|147442697|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.95|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|92.24|101.89|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||101.89|92.24|<0.0001
73953965|NCT02084082|147442698|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.77|STANDARD_ERROR_OF_MEAN|1.046|<|0.0001|TWO_SIDED|90.0|92.464|107.645|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||107.645|92.464|<0.0001
74033388|NCT00830037|147619469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.79|TWO_SIDED|95.0|-2.9|2.3||a = 0.05|Mixed Models Analysis|Wald test||The analysis of the primary outcome was intention to treat, if the patient received at least one dose of the randomized drug (which was the case for each subject). A linear mixed model was used with GFR as the outcome variable. Fixed effects were indicator variables for time (treated as a continuous variable), treatment, and their interaction. Random effects were subject and time with unstructured covariance; statistical inference was made using the maximum likelihood estimator.||2.3|-2.9|0.79
73953966|NCT02084082|147442698|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.97|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|94.95|103.16|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||103.160|94.950|<0.0001
73953967|NCT02084082|147442699|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.72|STANDARD_ERROR_OF_MEAN|1.028|<|0.0001|TWO_SIDED|90.0|95.163|104.493|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||104.493|95.163|<0.0001
73953968|NCT02084082|147442699|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.36|STANDARD_ERROR_OF_MEAN|1.132||0.0778|TWO_SIDED|90.0|77.082|122.963|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||122.963|77.082|0.0778
73953969|NCT02084082|147442700|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.11|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.37|106.35|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||106.35|92.37|<0.0001
73953970|NCT02084082|147442700|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.18|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|93.34|103.27|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||103.27|93.34|<0.0001
74033389|NCT00830037|147619470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035||||0.83|TWO_SIDED|95.0|-0.294|0.365||a = 0.05|Mixed Models Analysis|Wald test||The secondary analysis examined the mean change from baseline proteinuria (log protein to creatinine ratio) at 2 years. The between-groups difference in mean change from baseline is reported with a 95% confidence interval and the p-value from the Wald test.||0.365|-0.294|0.83
74033390|NCT01555463|147619477|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|center-adjusted||||||<.001
74033391|NCT01555463|147619478|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|F-test for treatment effect of the ANCOVA model with treatment group and study center as the factors and baseline lesion count as the covariate.||||||<.001
74039495|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.52||0.3654|TWO_SIDED|95.0|-1.5|0.55|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.55|-1.50|0.3654
73873594|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
74089561|NCT00773734|147731786|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.2||||0.059|TWO_SIDED|95.0|-0.4|26.8|||Chi-squared|||||26.8|-0.4|0.0590
73873595|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
73873596|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
74089562|NCT00773734|147731786|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|22.1||||0.0023|TWO_SIDED|95.0|8.3|36.0|||Chi-squared|||||36.0|8.3|0.0023
73953971|NCT04736056|147442713|OTHER||Cohen's d effect size|1.2|||||TWO_SIDED|95.0|0.73|1.66||||||0 to 12 weeks||1.66|0.73|
73953972|NCT04736056|147442713|OTHER||Cohen's d effect size|1.07|||||TWO_SIDED|95.0|0.61|1.51||||||0 to 16 weeks||1.51|0.61|
73953973|NCT04736056|147442714|OTHER||Cohen's d effect size|0.35|||||TWO_SIDED|95.0|-0.02|0.71||||||0 to 12 weeks||0.71|-0.02|
73953974|NCT04736056|147442714|OTHER||Cohen's d effect size|0.25|||||TWO_SIDED|95.0|-0.12|0.61||||||0 to 16 weeks||0.61|-0.12|
74089563|NCT00773734|147731786|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.2|||<|0.0001|TWO_SIDED|95.0|21.6|48.9|||Chi-squared|||||48.9|21.6|<0.0001
74089564|NCT00773734|147731788|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.4||||0.1776|TWO_SIDED|95.0|-1.5|8.2|||Chi-squared|||||8.2|-1.5|0.1776
74089565|NCT00773734|147731788|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|8.1||||0.0158|TWO_SIDED|95.0|1.6|14.5|||Chi-squared|||||14.5|1.6|0.0158
74089566|NCT00773734|147731788|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.2||||0.0051|TWO_SIDED|95.0|3.2|17.2|||Chi-squared|||||17.2|3.2|0.0051
74089567|NCT00773734|147731793|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.7||||0.0156|TWO_SIDED|95.0|-24.8|-2.6|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-2.6|-24.8|0.0156
73953975|NCT04736056|147442715|OTHER||Cohen's d effect size|0.78|||||TWO_SIDED|95.0|0.38|1.18||||||0 to 12 weeks||1.18|0.38|
74089568|NCT00773734|147731793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-36.4|-13.9|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-13.9|-36.4|<0.0001
74089569|NCT00773734|147731793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-44.0|-21.7|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-21.7|-44.0|<0.0001
74089570|NCT00773734|147731795|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.2||||0.6541|TWO_SIDED|95.0|-11.7|7.3|||Chi-squared|||||7.3|-11.7|0.6541
74089571|NCT00773734|147731795|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.4||||0.0402|TWO_SIDED|95.0|0.6|24.1|||Chi-squared|||||24.1|0.6|0.0402
73873597|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
73873598|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873599|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
73953976|NCT04736056|147442715|OTHER||Cohen's d effect size|0.5|||||TWO_SIDED|95.0|0.11|0.87||||||0 to 16 weeks||0.87|0.11|
73953977|NCT04736056|147442716|OTHER||Cohen's d effect size|0.23|||||TWO_SIDED|95.0|-0.13|0.58||||||0 to 12 weeks||0.58|-0.13|
73953978|NCT04736056|147442716|OTHER||Cohen's d effect size|0.31|||||TWO_SIDED|95.0|-0.05|0.68||||||0 to 16 weeks||0.68|-0.05|
73953979|NCT04736056|147442717|OTHER||Cohen's d effect size|0.32|||||TWO_SIDED|95.0|-0.04|0.68||||||0 to 12 weeks||0.68|-0.04|
73953980|NCT04736056|147442717|OTHER||Cohen's d effect size|0.61|||||TWO_SIDED|95.0|0.22|1.0||||||0 to 16 weeks||1.00|0.22|
73953981|NCT04736056|147442718|OTHER||Cohen's d effect size|0.38|||||TWO_SIDED|95.0|0.01|0.74||||||0 to 12 weeks||0.74|0.01|
73953982|NCT04736056|147442718|OTHER||Cohen's d effect size|0.47|||||TWO_SIDED|95.0|0.09|0.85||||||0 to 16 weeks||0.85|0.09|
73953983|NCT04736056|147442719|OTHER||Cohen's d effect size|0.29|||||TWO_SIDED|95.0|-0.07|0.65||||||0 to 12 weeks||0.65|-0.07|
73953984|NCT04736056|147442719|OTHER||Cohen's d effect size|0.6|||||TWO_SIDED|95.0|0.21|0.99||||||||0.99|0.21|
73953985|NCT04736056|147442720|OTHER||Cohen's d effect size|0.54|||||TWO_SIDED|95.0|0.16|0.91||||||0 to 12 weeks||0.91|0.16|
73953986|NCT04736056|147442720|OTHER||Cohen's d effect size|0.51|||||TWO_SIDED|95.0|0.12|0.89||||||0 to 16 weeks||0.89|0.12|
74089572|NCT00773734|147731795|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|21.1||||0.0011|TWO_SIDED|95.0|8.8|33.4|||Chi-squared|||||33.4|8.8|0.0011
74089573|NCT00773734|147731799|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.2||||0.002|TWO_SIDED|95.0|-33.0|-7.5|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate||||-7.5|-33.0|0.0020
74089574|NCT00773734|147731799|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.9|||<|0.0001|TWO_SIDED|95.0|-42.9|-17.0|||ANCOVA|based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate||||-17.0|-42.9|<0.0001
74089575|NCT00773734|147731799|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-42.4|||<|0.0001|TWO_SIDED|95.0|-55.2|-29.5||Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate|ANCOVA|||||-29.5|-55.2|<0.0001
74089576|NCT00773734|147731801|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.3||||0.1322|TWO_SIDED|95.0|-3.1|0.4|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||0.4|-3.1|0.1322
74089577|NCT00773734|147731801|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.9|-2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-2.3|-5.9|<0.0001
74089578|NCT00773734|147731801|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.6||||0.0047|TWO_SIDED|95.0|-4.3|-0.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-0.8|-4.3|0.0047
74089579|NCT00773734|147731803|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.3||||0.0078|TWO_SIDED|95.0|0.9|5.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||5.8|0.9|0.0078
73953987|NCT04736056|147442721|OTHER||Cohen's d effect size|0.89|||||TWO_SIDED|95.0|0.47|1.3||||||0 to 12 weeks||1.30|0.47|
73953988|NCT04736056|147442721|OTHER||Cohen's d effect size|0.66|||||TWO_SIDED|95.0|0.26|1.05||||||0 to 16 weeks||1.05|0.26|
73953989|NCT04736056|147442722|OTHER||Cohen's d effect size|-0.4|||||TWO_SIDED|95.0|-0.76|-0.03||||||0 to 12 weeks||-0.03|-0.76|
73953990|NCT04736056|147442722|OTHER||Cohen's d effect size|-0.34|||||TWO_SIDED|95.0|-0.71|0.03||||||0 to 16 weeks||0.03|-0.71|
73953991|NCT04736056|147442723|OTHER||Cohen's d effect size|0.0|||||TWO_SIDED|95.0|-0.35|0.35||||||0 to 12 weeks||0.35|-0.35|
74033392|NCT02026271|147619496|OTHER||||||||||||||||||"MTD was not determined in this study. Dose escalation decision rules were based on a standard 3+3 design modified to independently evaluate the two stratified subject groups that may exhibit different safety and tolerability profiles.~The study was planned to explore 4 veledimex (V) dose cohorts of 20, 40, 80 and 120 mg once daily, and two doses of Ad-RTS-hIL-12 (2x10\^11vp and 1x10\^12vp). Dose cohorts were treated at 10, 20, 30 and 40 mg of V. Only one dose of Ad-RTS-hIL-12 was explored (2x10\^11vp).~If ≥ 33% of subjects in the expansion cohort experience DLTs, additional subjects may be enrolled at the next lower dose, or at an intermediate dose, as recommended by the SRC.~Grp 1: After 20mg cohort, SRC approved 40mg, which was deemed the MAD due to DLTs. SRC approved 30mg cohort to determine MTD, but due to poor compliance, SRC opened a 20mg exp cohort and then an intermediate 10mg cohort. Based on V compliance and efficacy, 20mg was determined to be the optimal dose."|||
74033393|NCT04370028|147619503|SUPERIORITY||Mean Difference (Net)|4.57|||<|1e-05|TWO_SIDED|95.0|4.42|4.72|||t-test, 2 sided|Paired test was performed||||4.72|4.42|<0.00001
74089580|NCT00773734|147731803|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.5||||0.0068|TWO_SIDED|95.0|1.0|6.0|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||6.0|1.0|0.0068
73953992|NCT04736056|147442723|OTHER||Cohen's d effect size|-0.28|||||TWO_SIDED|95.0|-0.64|0.09||||||0 to 16 weeks||0.09|-0.64|
74033394|NCT04370028|147619504|SUPERIORITY||Odds Ratio (OR)|7.2|||<|1e-05|TWO_SIDED|95.0|6.01|8.67|||Fisher Exact||OR estimated (week 1 to week 12) the higher the better|Odds ratio of occuring MoCA score \<26 was assessed||8.67|6.01|<0.00001
74033395|NCT04370028|147619505|SUPERIORITY||Odds Ratio (OR)|5.31|||<|1e-05|TWO_SIDED|95.0|4.28|6.64|||Fisher Exact||OR estimated (week 1 to week 12) the higher the better|Odds ratio of occuring MoCA score \<17 was assessed||6.64|4.28|<0.00001
73873600|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73953993|NCT04736056|147442724|OTHER||Cohen's d effect size|0.1|||||TWO_SIDED|95.0|-0.45|0.26||||||||0.26|-0.45|
73953994|NCT04736056|147442724|OTHER||Cohen's d effect size|0.09|||||TWO_SIDED|95.0|-0.27|0.45||||||0 to 16 weeks||0.45|-0.27|
73953995|NCT04736056|147442725|OTHER||Cohen's d effect size|-0.035|||||TWO_SIDED|95.0|-0.71|0.01||||||0 to 12 weeks||0.01|-0.71|
73953996|NCT04736056|147442725|OTHER||Cohen's d effect size|-0.29|||||TWO_SIDED|95.0|-0.65|0.08||||||0 to 16 weeks||0.08|-0.65|
73953997|NCT04736056|147442726|OTHER||Cohen's d effect size|-0.34|||||TWO_SIDED|95.0|-0.7|0.03||||||0 to 12 weeks||0.03|-0.70|
73953998|NCT04736056|147442726|OTHER||Cohen's d effect size|-0.47|||||TWO_SIDED|95.0|-0.85|-0.09||||||0 to 16 weeks||-0.09|-0.85|
73953999|NCT03437668|147442729|SUPERIORITY|To test for a differential treatment effect, we fit a linear mixed with group, time, and a group by time interaction as the predictors and random intercepts to account for the correlations induced by the repeated measurements within subjects. Given the form of the trajectories and the small sample size, we chose to treat time as continuous to minimize the number of degrees of freedom and the risk of overfitting.|Slope|-0.22||||0.31|TWO_SIDED|||||p-value is for the interaction of time and treatment group in the mixed model|Mixed Models Analysis|||||||.31
73954000|NCT04996069|147442751|SUPERIORITY|No power calculation performed.||||||0.45||||||p value threshold is .05|t-test, 2 sided|||||||.45
73954001|NCT04091672|147442767|NON_INFERIORITY|"The one-sided 97.5% confidence interval (97.5% CI) was calculated for the difference (Control-RECELL) in percentages of subjects with confirmed treatment area closure.~The calculation used the normal approximation taking correlation into account. In order for the null hypothesis to be rejected and the non-inferiority of RECELL to be established, the upper limit of the 97.5% CI had to be less than 10%."||||||0.005|||||||1-sided z-test of proportions|alpha=0.025||||||.005
73954002|NCT04091672|147442768|SUPERIORITY|A geometric mean ratio (GMR of ratios) 95% CI with a lower bound exceeding 1 would indicate superiority of RECELL over Control with respect to this endpoint.||||||0.001|||||||GMR of ratios|||||||0.001
74033396|NCT04370028|147619506|SUPERIORITY||Mean Difference (Net)|2.375|||<|0.07|TWO_SIDED|95.0|-0.21|4.96|||ANOVA|||Change of mean MoCA score||4.96|-0.21|<0.07
74033397|NCT04370028|147619506|SUPERIORITY||Mean Difference (Net)|4.74|||<|0.01|TWO_SIDED|95.0|4.17|5.31|||ANOVA|||Change of mean MoCA score||5.31|4.17|<0.01
74033398|NCT04370028|147619506|SUPERIORITY||Mean Difference (Net)|4.55|||<|0.01|TWO_SIDED|95.0|4.16|4.94|||ANOVA|||Change of mean MoCA score||4.94|4.16|<0.01
74033399|NCT04370028|147619506|SUPERIORITY||Mean Difference (Net)|4.49|||<|0.01|TWO_SIDED|95.0|3.7|5.27|||ANOVA|||Change of mean MoCA score||5.27|3.7|<0.01
74033400|NCT04370028|147619508|SUPERIORITY||Mean Difference (Net)|0.803|STANDARD_ERROR_OF_MEAN|0.246||0.0011|TWO_SIDED|95.0|0.321|1.28|||ANOVA|||||1.28|0.321|0.0011
74033401|NCT00540449|147619510|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-0.4|||<|0.0001||95.0|-5.9|5.2||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||5.2|-5.9|<0.0001
74089581|NCT00773734|147731803|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.6||||0.0045|TWO_SIDED|95.0|1.1|6.1|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||6.1|1.1|0.0045
73954003|NCT01796665|147442774|EQUIVALENCE|provides 85% power of success|Equivalence ratio|96.57|||||TWO_SIDED|90.0|92.5|105.2|||Fieller's method|||||105.2|92.5|
74089582|NCT00773734|147731804|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.6||||0.6097|TWO_SIDED|95.0|-1.6|2.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||2.8|-1.6|0.6097
74089583|NCT00773734|147731804|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.3||||0.2424|TWO_SIDED|95.0|-0.9|3.6|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||3.6|-0.9|0.2424
73954004|NCT01796665|147442775|EQUIVALENCE|provides 85% power of success|Equivalence ratio|99.96|||||TWO_SIDED|90.0|92.9|110.5|||Fieller's method|||||110.5|92.9|
73954005|NCT01796665|147442776|EQUIVALENCE|provides 85% power of success|Equivalence ratio|-1.14|||||TWO_SIDED|90.0|-13.23|-1.13|||Fieller's method|||||-1.13|-13.23|
73954006|NCT01345292|147442817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.44|STANDARD_ERROR_OF_MEAN|1.556|<|0.001|TWO_SIDED|95.0|8.37|14.5||If Sensodyne is better than Crest Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Sensodyne and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||14.50|8.37|<0.001
73954007|NCT01345292|147442817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|1.566|<|0.001|TWO_SIDED|95.0|5.24|11.42||If Potassium Oxalate Mouth Rinse is better than Crest Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouth Rinse and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||11.42|5.24|<0.001
73954008|NCT01345292|147442818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|1.45|4.65||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.65|1.45|<0.001
73954009|NCT01345292|147442818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.818||0.004|TWO_SIDED|95.0|0.8|4.02||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.02|0.80|0.004
73954010|NCT01345292|147442819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|2.091||0.324|TWO_SIDED|95.0|-6.19|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.06|-6.19|0.324
73954011|NCT01345292|147442819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.43|STANDARD_ERROR_OF_MEAN|2.093||0.035|TWO_SIDED|95.0|-8.56|-0.31||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.31|-8.56|0.035
73954012|NCT01345292|147442820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|STANDARD_ERROR_OF_MEAN|2.551|<|0.001|TWO_SIDED|95.0|-13.6|-3.52||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.52|-13.6|<0.001
73954013|NCT01345292|147442820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|2.553|<|0.001|TWO_SIDED|95.0|-15.2|-5.13||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.13|-15.2|<0.001
73954014|NCT01345292|147442821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.91|STANDARD_ERROR_OF_MEAN|2.271||0.032|TWO_SIDED|95.0|-9.38|-0.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.43|-9.38|0.032
73954015|NCT01345292|147442821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|2.288||0.136|TWO_SIDED|95.0|-7.93|1.09||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.09|-7.93|0.136
73954016|NCT01345292|147442822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|2.508|<|0.001|TWO_SIDED|95.0|-16.1|-6.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-6.23|-16.1|<0.001
73981104|NCT02607956|147507596|OTHER|||||||0.74|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.74
74089584|NCT00773734|147731804|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.9528|TWO_SIDED|95.0|-2.2|2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||2.3|-2.2|0.9528
74033402|NCT00540449|147619511|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.3|||<|0.0001||95.0|-5.4|5.9|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||5.9|-5.4|<0.0001
74033403|NCT00540449|147619512|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-3.2||||0.0055||95.0|-9.4|3.1|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||3.1|-9.4|0.0055
74089585|NCT01287039|147731909|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.501|||<|0.0001|TWO_SIDED|95.0|0.3726|0.6737||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.6737|0.3726|<0.0001
74089586|NCT01287039|147731910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.137|STANDARD_ERROR_OF_MEAN|0.0311|<|0.0001|TWO_SIDED|95.0|0.076|0.198|||Mixed Model Repeated Measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.198|0.076|<0.0001
73873601|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
73954017|NCT01345292|147442822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|2.527|<|0.001|TWO_SIDED|95.0|-15.2|-5.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.25|-15.2|<0.001
73954018|NCT01345292|147442823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|2.012||0.533|TWO_SIDED|95.0|-5.22|2.71||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.71|-5.22|0.533
73954019|NCT01345292|147442823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.023||0.522|TWO_SIDED|95.0|-5.29|2.69||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.69|-5.29|0.522
73954020|NCT01345292|147442824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.53|STANDARD_ERROR_OF_MEAN|2.331|<|0.001|TWO_SIDED|95.0|-13.1|-3.94||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.94|-13.1|<0.001
73954021|NCT01345292|147442824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.13|STANDARD_ERROR_OF_MEAN|2.344||0.01|TWO_SIDED|95.0|-10.8|-1.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.51|-10.8|0.010
73954022|NCT00951561|147442848|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation is performed in nQuery version 5.0 with the following stipulations: alpha is 0.05; response for both ibuprofen and Vipon is 85%; delta is 10%; no difference in response rates is expected between the two treatment arms, and power is 80%. This calculation is performed for an equivalence/non-inferiority primary analysis.|Difference in % of Uses from Mixed Model|-1.6|||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
73954023|NCT02092987|147442849|SUPERIORITY_OR_OTHER_LEGACY||interaction term|||||0.7|||||||Mixed Models Analysis|||Hypothesis testing in changes in mean from baseline to follow-up were were conducted primarily with mixed models. Sensitivity analyses were conducted using ANOVA.||||0.70
74033404|NCT00540449|147619513|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-1.7||||0.0013||95.0|-8.0|4.5|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.||||4.5|-8.0|0.0013
74033405|NCT01204658|147619528|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
73954024|NCT02092987|147442850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||comparison of arms using mixed models|Mixed Models Analysis|||||||0.77
74033406|NCT01204658|147619528|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
74033407|NCT01204658|147619528|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.62|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.62|0.003
74033408|NCT01204658|147619528|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
74033409|NCT01204658|147619529|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
73954025|NCT02092987|147442851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
73954026|NCT02092987|147442852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
73954027|NCT02092987|147442853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
73954028|NCT02092987|147442854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
73954029|NCT02092987|147442855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Mixed Models Analysis|||||||0.62
73954030|NCT02028884|147442866|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0184|TWO_SIDED|95.0|0.16|0.88|||Log Rank|||Stratified by Baseline annualized relapse rate (ARR: 1, \> 1) and geographic region (Asia, EU/Other).||0.88|0.16|0.0184
73954031|NCT02028884|147442867|SUPERIORITY||Mean Difference (Final Values)|6.376|STANDARD_ERROR_OF_MEAN|3.344||0.0602|TWO_SIDED|95.0|-0.28|13.033|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||13.033|-0.280|0.0602
73954032|NCT02028884|147442868|SUPERIORITY||Mean Difference (Final Values)|-2.089|STANDARD_ERROR_OF_MEAN|1.338||0.1224|TWO_SIDED|95.0|-4.752|0.574|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||0.574|-4.752|0.1224
73954033|NCT02373813|147442897|SUPERIORITY||Risk Difference (RD)|20.8|STANDARD_ERROR_OF_MEAN|6.7||0.004|TWO_SIDED|95.0|7.6|33.9||The risk difference and its p-value were estimated from the chi-squared test with continuity correction.|Chi-squared, Corrected|||||33.9|7.6|0.004
73954034|NCT02373813|147442898|SUPERIORITY||Risk Difference (RD)|24.2|STANDARD_ERROR_OF_MEAN|8.3||0.006|TWO_SIDED|95.0|7.9|40.5||The risk difference and its p-value were estimated from the chi-squared test with continuity correction.|Chi-squared, Corrected|||||40.5|7.9|0.006
73954035|NCT02373813|147442899|SUPERIORITY||Treatment Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|95.0|-0.48|0.27|||two sample t-test|||Baseline||0.27|-0.48|0.58
74033410|NCT01204658|147619529|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
74039496|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1782|TWO_SIDED|95.0|-1.71|0.32|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.32|-1.71|0.1782
73954036|NCT02373813|147442899|SUPERIORITY||Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.85|TWO_SIDED|95.0|-0.37|0.31|||two sample t-test|||Baseline||0.31|-0.37|0.85
73954037|NCT02373813|147442899|SUPERIORITY||Treatment Difference|-2.61|STANDARD_ERROR_OF_MEAN|1.66||0.12|TWO_SIDED|95.0|-5.89|0.67|||two sample t-test|||Week 12||0.67|-5.89|0.12
73954038|NCT02373813|147442899|SUPERIORITY||Treatment Difference|-2.64|STANDARD_ERROR_OF_MEAN|1.26||0.037|TWO_SIDED|95.0|-5.12|-0.16|||two sample t-test|||Week 12||-0.16|-5.12|0.037
73954039|NCT02373813|147442899|SUPERIORITY||Treatment Difference|-2.33|STANDARD_ERROR_OF_MEAN|1.46||0.063|TWO_SIDED|95.0|-4.8|0.13|||two sample t-test|||Week 24||0.13|-4.80|0.063
73954040|NCT02373813|147442899|SUPERIORITY||Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.34||0.64|TWO_SIDED|95.0|-3.27|2.01|||two sample t-test|||Week 24||2.01|-3.27|0.64
73954041|NCT02373813|147442899|SUPERIORITY||Treatment Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.9||0.031|TWO_SIDED|95.0|-3.09|-0.15|||two sample t-test|||Week 36||-0.15|-3.09|0.031
73954042|NCT02373813|147442899|SUPERIORITY||Treatment Difference|-1.77|STANDARD_ERROR_OF_MEAN|0.71||0.015|TWO_SIDED|95.0|-3.2|-0.35|||two sample t-test|||Week 36||-0.35|-3.20|0.015
73954043|NCT02373813|147442899|SUPERIORITY||Treatment Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.87||0.58|TWO_SIDED|95.0|-2.55|1.45|||two sample t-test|||Week 48||1.45|-2.55|0.58
73954044|NCT02373813|147442899|SUPERIORITY||Treatment Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.45||0.02|TWO_SIDED|95.0|-1.99|-0.17|||two sample t-test|||Week 48||-0.17|-1.99|0.020
73954045|NCT02373813|147442900|SUPERIORITY||Treatment Difference|-2.46|STANDARD_ERROR_OF_MEAN|1.63||0.13|TWO_SIDED|95.0|-5.68|0.77|||two sample t-test|||Change at Week 12||0.77|-5.68|0.13
73954046|NCT02373813|147442900|SUPERIORITY||Treatment Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.25||0.045|TWO_SIDED|95.0|-4.99|-0.06|||two sample t-test|||Change at Week 12||-0.06|-4.99|0.045
73954047|NCT02373813|147442900|SUPERIORITY||Treatment Difference|-2.27|STANDARD_ERROR_OF_MEAN|1.45||0.071|TWO_SIDED|95.0|-4.75|0.2|||two sample t-test|||Change at Week 24||0.20|-4.75|0.071
73954048|NCT02373813|147442900|SUPERIORITY||Treatment Difference|-0.64|STANDARD_ERROR_OF_MEAN|1.34||0.63|TWO_SIDED|95.0|-3.28|2.0|||two sample t-test|||Change at Week 24||2.00|-3.28|0.63
73981105|NCT02607956|147507597|OTHER||Difference in LSM|0.08||||0.081|TWO_SIDED|95.0|-0.01|0.17|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.17|-0.01|0.081
73981106|NCT02607956|147507598|OTHER||Difference in LSM|0.06||||0.18|TWO_SIDED|95.0|-0.03|0.15|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.15|-0.03|0.18
73981107|NCT02607956|147507599|OTHER||Difference in LSM|0.09||||0.054|TWO_SIDED|95.0|0.0|0.18|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.18|0.00|0.054
73954049|NCT02373813|147442900|SUPERIORITY||Treatment Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.91||0.037|TWO_SIDED|95.0|-3.11|-0.1|||two sample t-test|||Change at Week 36||-0.10|-3.11|0.037
73981108|NCT02607956|147507600|OTHER||Difference in LSM|-23.0||||0.096|TWO_SIDED|95.0|-49.0|4.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||4|-49|0.096
73981109|NCT02607956|147507601|OTHER||Difference in LSM|-47.0||||0.008|TWO_SIDED|95.0|-81.0|-12.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||-12|-81|0.008
74039497|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.52||0.3981|TWO_SIDED|95.0|-1.47|0.58|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.58|-1.47|0.3981
73954050|NCT02373813|147442900|SUPERIORITY||Treatment Difference|-1.84|STANDARD_ERROR_OF_MEAN|0.73||0.013|TWO_SIDED|95.0|-3.3|-0.39|||two sample t-test|||Change at Week 36||-0.39|-3.30|0.013
73954051|NCT02373813|147442900|SUPERIORITY||Treatment Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.88||0.62|TWO_SIDED|95.0|-2.54|1.53|||two sample t-test|||Change at Week 48||1.53|-2.54|0.62
73954052|NCT02373813|147442900|SUPERIORITY||Treatment Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.45||0.015|TWO_SIDED|95.0|-2.02|-0.22|||two sample t-test|||Change at Week 48||-0.22|-2.02|0.015
73954053|NCT02373813|147442901|SUPERIORITY||Treatment Difference|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.75|TWO_SIDED|95.0|-0.19|0.26|||two sample t-test|||Baseline||0.26|-0.19|0.75
73954054|NCT02373813|147442901|SUPERIORITY||Treatment Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.43|TWO_SIDED|95.0|-0.11|0.27|||two sample t-test|||Baseline||0.27|-0.11|0.43
73954055|NCT02373813|147442901|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.23||0.049|TWO_SIDED|95.0|-0.91|0.0|||two sample t-test|||Week 12||0.00|-0.91|0.049
73954056|NCT02373813|147442901|SUPERIORITY||Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.032|TWO_SIDED|95.0|-0.77|-0.04|||two sample t-test|||Week 12||-0.04|-0.77|0.032
73954057|NCT02373813|147442901|SUPERIORITY||Treatment Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.18|TWO_SIDED|95.0|-0.58|0.11|||two sample t-test|||Week 24||0.11|-0.58|0.18
73954058|NCT02373813|147442901|SUPERIORITY||Treatment Difference|0.14|STANDARD_ERROR_OF_MEAN|0.19||0.48|TWO_SIDED|95.0|-0.24|0.51|||two sample t-test|||Week 24||0.51|-0.24|0.48
73954059|NCT02373813|147442901|SUPERIORITY||Treatment Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.35|TWO_SIDED|95.0|-0.51|0.18|||two sample t-test|||Week 36||0.18|-0.51|0.35
73954060|NCT02373813|147442901|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.28|TWO_SIDED|95.0|-0.41|0.12|||two sample t-test|||Week 36||0.12|-0.41|0.28
73954061|NCT02373813|147442901|SUPERIORITY||Treatment Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.48|TWO_SIDED|95.0|-0.44|0.21|||two sample t-test|||Week 48||0.21|-0.44|0.48
73954062|NCT02373813|147442901|SUPERIORITY||Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.92|TWO_SIDED|95.0|-0.26|0.24|||two sample t-test|||Week 48||0.24|-0.26|0.92
73981110|NCT02607956|147507602|OTHER||Difference in LSM|-14.0||||0.48|TWO_SIDED|95.0|-52.0|25.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||25|-52|0.48
74089587|NCT01287039|147731911|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.0967||0.0143|TWO_SIDED|95.0|0.048|0.428|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.428|0.048|0.0143
73954063|NCT02373813|147442902|SUPERIORITY||Treatment Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.22||0.032|TWO_SIDED|95.0|-0.91|-0.04|||two sample t-test|||Change at Week 12||-0.04|-0.91|0.032
73954064|NCT02373813|147442902|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.005|TWO_SIDED|95.0|-0.78|-0.15|||two sample t-test|||Change at Week 12||-0.15|-0.78|0.005
73954065|NCT02373813|147442902|SUPERIORITY||Treatment Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.058|TWO_SIDED|95.0|-0.63|0.01|||two sample t-test|||Change at Week 24||0.01|-0.63|0.058
73954066|NCT02373813|147442902|SUPERIORITY||Treatment Difference|0.05|STANDARD_ERROR_OF_MEAN|0.17||0.78|TWO_SIDED|95.0|-0.29|0.38|||two sample t-test|||Change at Week 24||0.38|-0.29|0.78
73954067|NCT02373813|147442902|SUPERIORITY||Treatment Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.27|TWO_SIDED|95.0|-0.49|0.14|||two sample t-test|||Change at Week 36||0.14|-0.49|0.27
73954068|NCT02373813|147442902|SUPERIORITY||Treatment Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.078|TWO_SIDED|95.0|-0.47|0.03|||two sample t-test|||Change at Week 36||0.03|-0.47|0.078
73954069|NCT02373813|147442902|SUPERIORITY||Treatment Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.47|TWO_SIDED|95.0|-0.43|0.2|||two sample t-test|||Week 48||0.20|-0.43|0.47
73954070|NCT02373813|147442902|SUPERIORITY||Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.39|TWO_SIDED|95.0|-0.33|0.13|||two sample t-test|||Change at Week 48||0.13|-0.33|0.39
73954071|NCT02373813|147442903|SUPERIORITY||Treatment Difference|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.6|TWO_SIDED|95.0|-0.09|0.15|||two sample t-test|||Baseline||0.15|-0.09|0.60
73954072|NCT02373813|147442903|SUPERIORITY||Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.97|TWO_SIDED|95.0|-0.1|0.1|||two sample t-test|||Baseline||0.10|-0.10|0.97
73954073|NCT02373813|147442903|SUPERIORITY||Treatment Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.044|TWO_SIDED|95.0|-0.82|-0.01|||two sample t-test|||Week 12||-0.01|-0.82|0.044
73954074|NCT02373813|147442903|SUPERIORITY||Treatment Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.76|-0.14|||two sample t-test|||Week 12||-0.14|-0.76|0.004
73954075|NCT02373813|147442903|SUPERIORITY||Treatment Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.009|TWO_SIDED|95.0|-0.66|-0.1|||two sample t-test|||Week 24||-0.10|-0.66|0.009
73954076|NCT02373813|147442903|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.34|TWO_SIDED|95.0|-0.46|0.16|||two sample t-test|||Week 24||0.16|-0.46|0.34
73954077|NCT02373813|147442903|SUPERIORITY||Treatment Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.046|TWO_SIDED|95.0|-0.47|0.0|||two sample t-test|||Week 36||0.00|-0.47|0.046
73954078|NCT02373813|147442903|SUPERIORITY||Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.49|-0.08|||two sample t-test|||Week 36||-0.08|-0.49|0.006
73954079|NCT02373813|147442903|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.25|TWO_SIDED|95.0|-0.4|-0.1|||two sample t-test|||Week 48||-0.10|-0.40|0.25
73954080|NCT02373813|147442903|SUPERIORITY||Treatment Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.37|-0.03|||two sample t-test|||Week 48||-0.03|-0.37|0.021
73954081|NCT02373813|147442904|SUPERIORITY||Treatment Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.82|-0.04|||two sample t-test|||Change at Week 12||-0.04|-0.82|0.030
73954082|NCT02373813|147442904|SUPERIORITY||Treatment Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.005|TWO_SIDED|95.0|-0.72|-0.13|||two sample t-test|||Change at Week 12||-0.13|-0.72|0.005
73954083|NCT02373813|147442904|SUPERIORITY||Treatment Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.69|-0.15|||two sample t-test|||Change at Week 24||-0.15|-0.69|0.002
73954084|NCT02373813|147442904|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.34|TWO_SIDED|95.0|-0.46|0.16|||two sample t-test|||Change at Week 24||0.16|-0.46|0.34
73954085|NCT02373813|147442904|SUPERIORITY||Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.13||0.014|TWO_SIDED|95.0|-0.52|-0.06|||two sample t-test|||Change at Week 36||-0.06|-0.52|0.014
73954086|NCT02373813|147442904|SUPERIORITY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.51|-0.1|||two sample t-test|||Change at Week 36||-0.10|-0.51|0.004
73954087|NCT02373813|147442904|SUPERIORITY||Treatment Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|95.0|-0.43|0.05|||two sample t-test|||Change at Week 48||0.05|-0.43|0.12
73954088|NCT02373813|147442904|SUPERIORITY||Treatment Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.01|TWO_SIDED|95.0|-0.37|-0.05|||two sample t-test|||Change at Week 48||-0.05|-0.37|0.010
73954089|NCT02373813|147442905|SUPERIORITY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.067|TWO_SIDED|95.0|-0.62|0.02|||two sample t-test|||Baseline||0.02|-0.62|0.067
73954090|NCT02373813|147442905|SUPERIORITY||Treatment Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.59|TWO_SIDED|95.0|-0.41|0.23|||two sample t-test|||Baseline||0.23|-0.41|0.59
73954091|NCT02373813|147442905|SUPERIORITY||Treatment Difference|-2.46|STANDARD_ERROR_OF_MEAN|1.62||0.13||95.0|-5.66|0.74|||two sample t-test|||Week 12||0.74|-5.66|0.13
73954092|NCT02373813|147442905|SUPERIORITY||Treatment Difference|-2.34|STANDARD_ERROR_OF_MEAN|1.23||0.059|TWO_SIDED|95.0|-4.76|0.09|||two sample t-test|||Week 12||0.09|-4.76|0.059
73954093|NCT02373813|147442905|SUPERIORITY||Treatment Difference|-2.72|STANDARD_ERROR_OF_MEAN|1.38||0.017|TWO_SIDED|95.0|-4.95|-0.5|||two sample t-test|||Week 24||-0.50|-4.95|0.017
73954094|NCT02373813|147442905|SUPERIORITY||Treatment Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.32||0.74|TWO_SIDED|95.0|-3.04|2.15|||two sample t-test|||Week 24||2.15|-3.04|0.74
73954095|NCT02373813|147442905|SUPERIORITY||Treatment Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.9||0.039|TWO_SIDED|95.0|-3.03|-0.08|||two sample t-test|||Week 36||-0.08|-3.03|0.039
73954096|NCT02373813|147442905|SUPERIORITY||Treatment Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.72||0.023|TWO_SIDED|95.0|-3.1|-0.23|||two sample t-test|||Week 36||-0.23|-3.10|0.023
73873602|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
73954097|NCT02373813|147442905|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.85||0.65|TWO_SIDED|95.0|-2.43|1.52|||two sample t-test|||Week 48||1.52|-2.43|0.65
73954098|NCT02373813|147442905|SUPERIORITY||Treatment Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.44||0.017|TWO_SIDED|95.0|-1.94|-0.19|||two sample t-test|||Week 48||-0.19|-1.94|0.017
73954099|NCT02373813|147442906|SUPERIORITY||Treatment Difference|-2.15|STANDARD_ERROR_OF_MEAN|1.59||0.18||95.0|-5.29|1.0|||two sample t-test|||Change at Week 12||1.00|-5.29|0.18
73954100|NCT02373813|147442906|SUPERIORITY||Treatment Difference|-2.24|STANDARD_ERROR_OF_MEAN|1.21||0.067|TWO_SIDED|95.0|-4.63|0.16|||two sample t-test|||Change at Week 12||0.16|-4.63|0.067
73954101|NCT02373813|147442906|SUPERIORITY||Treatment Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.37||0.035|TWO_SIDED|95.0|-4.62|-0.17|||two sample t-test|||Change at Week 24||-0.17|-4.62|0.035
73954102|NCT02373813|147442906|SUPERIORITY||Treatment Difference|-0.34|STANDARD_ERROR_OF_MEAN|1.3||0.79|TWO_SIDED|95.0|-2.91|2.23|||two sample t-test|||Change at Week 24||2.23|-2.91|0.79
73954103|NCT02373813|147442906|SUPERIORITY||Treatment Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.91||0.09|TWO_SIDED|95.0|-2.75|0.2|||two sample t-test|||Change at Week 36||0.20|-2.75|0.090
73954104|NCT02373813|147442906|SUPERIORITY||Treatment Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.72||0.029|TWO_SIDED|95.0|-3.06|-0.17|||two sample t-test|||Change at Week 36||-0.17|-3.06|0.029
73954105|NCT02373813|147442906|SUPERIORITY||Treatment Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.84||0.86|TWO_SIDED|95.0|-2.15|1.81|||two sample t-test|||Change at Week 48||1.81|-2.15|0.86
73954106|NCT02373813|147442906|SUPERIORITY||Treatment Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.43||0.021|TWO_SIDED|95.0|-1.88|-0.16|||two sample t-test|||Change at Week 48||-0.16|-1.88|0.021
73954107|NCT02373813|147442907|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.4||1|TWO_SIDED|95.0|-6.5|6.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||6.6|-6.5|1.00
73954108|NCT02373813|147442907|SUPERIORITY||Risk Difference (RD)|-3.9|STANDARD_ERROR_OF_MEAN|3.3||0.38|TWO_SIDED|95.0|-10.4|2.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||2.6|-10.4|0.38
73954109|NCT02373813|147442907|SUPERIORITY||Risk Difference (RD)|24.5|STANDARD_ERROR_OF_MEAN|7.9||0.007|TWO_SIDED|95.0|9.0|40.0|||Chi-squared, Corrected|||Week 12||40.0|9.0|0.007
73873603|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
73954110|NCT02373813|147442907|SUPERIORITY||Risk Difference (RD)|14.0|STANDARD_ERROR_OF_MEAN|6.9||0.063|TWO_SIDED|95.0|0.4|27.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||27.6|0.4|0.063
73954111|NCT02373813|147442907|SUPERIORITY||Risk Difference (RD)|23.2|STANDARD_ERROR_OF_MEAN|8.4||0.012|TWO_SIDED|95.0|6.7|39.8|||Chi-squared, Corrected|||Week 24||39.8|6.7|0.012
73954112|NCT02373813|147442907|SUPERIORITY||Risk Difference (RD)|17.8|STANDARD_ERROR_OF_MEAN|7.0||0.018|TWO_SIDED|95.0|4.1|31.5||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||31.5|4.1|0.018
73954113|NCT02373813|147442907|SUPERIORITY||Risk Difference (RD)|19.0|STANDARD_ERROR_OF_MEAN|8.6||0.044|TWO_SIDED|95.0|2.1|35.9|||Chi-squared, Corrected|||Week 36||35.9|2.1|0.044
73954114|NCT02373813|147442907|SUPERIORITY||Risk Difference (RD)|19.5|STANDARD_ERROR_OF_MEAN|7.0||0.01|TWO_SIDED|95.0|5.8|33.2|||Chi-squared, Corrected|||Week 36||33.2|5.8|0.010
73954115|NCT02373813|147442907|SUPERIORITY||Risk Difference (RD)|25.7|STANDARD_ERROR_OF_MEAN|8.6||0.005|TWO_SIDED|95.0|8.9|42.5||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||42.5|8.9|0.005
73954116|NCT02373813|147442907|SUPERIORITY||Risk Difference (RD)|21.6|STANDARD_ERROR_OF_MEAN|7.0||0.004|TWO_SIDED|95.0|7.9|35.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||35.2|7.9|0.004
73954117|NCT02373813|147442908|SUPERIORITY||Risk Difference (RD)|11.1|STANDARD_ERROR_OF_MEAN|8.4||0.25|TWO_SIDED|95.0|-5.4|27.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||27.6|-5.4|0.25
73954118|NCT02373813|147442908|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|6.7||1|TWO_SIDED|95.0|-12.5|13.8||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||13.8|-12.5|1.00
73954119|NCT02373813|147442908|SUPERIORITY||Risk Difference (RD)|1.6|STANDARD_ERROR_OF_MEAN|6.8||0.98|TWO_SIDED|95.0|-11.6|14.9||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||14.9|-11.6|0.98
73954120|NCT02373813|147442908|SUPERIORITY||Risk Difference (RD)|5.0|STANDARD_ERROR_OF_MEAN|5.7||0.48|TWO_SIDED|95.0|-6.2|16.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||16.2|-6.2|0.48
73954121|NCT02373813|147442908|SUPERIORITY||Risk Difference (RD)|11.3|STANDARD_ERROR_OF_MEAN|7.3||0.16|TWO_SIDED|95.0|-3.1|25.7||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||25.7|-3.1|0.16
73873604|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
73873605|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
74033411|NCT01204658|147619529|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.63|2.66||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-HD Group minus Synflorix Group.||2.66|-2.63|0.003
74033412|NCT01204658|147619529|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
74033413|NCT01286272|147619617|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.8457|TWO_SIDED|95.0|0.51|1.74|||Log Rank|||||1.74|0.51|0.8457
74033414|NCT00769704|147619647|SUPERIORITY_OR_OTHER||Treatment Difference|14.1|||<|0.0001|TWO_SIDED|95.0|9.3|19.0|||Fisher Exact|||The null hypothesis was that there was no difference in the durable response rate between the talimogene laherparepvec and control arms. Study success was defined as the rejection of this hypothesis such that talimogene laherparepvec was found to be superior to GM-CSF using the 2-sided Fisher's exact test, with a p-value of ≤ 0.0488.||19.0|9.3|<0.0001
74089588|NCT01287039|147731912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.0681||0.0001|TWO_SIDED|95.0|-0.399|-0.132|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||-0.132|-0.399|0.0001
74089589|NCT01287039|147731913|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.575|||<|0.0001|TWO_SIDED|95.0|0.44|0.75|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.||0.750|0.440|<0.0001
74089590|NCT01287039|147731914|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.0125|<|0.0001|TWO_SIDED|95.0|0.034|0.083|||Mixed model repeated measures|||For each week, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.083|0.034|<0.0001
73954122|NCT02373813|147442908|SUPERIORITY||Risk Difference (RD)|1.4|STANDARD_ERROR_OF_MEAN|5.3||0.94|TWO_SIDED|95.0|-9.0|11.9||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||11.9|-9.0|0.94
73873606|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
74033415|NCT00769704|147619648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0511|TWO_SIDED|95.0|0.62|1.0|||Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average death rate and a longer overall survival for talimogene laherparepvec relative to GM-CSF.|The primary method for analysis of overall survival was an unadjusted log-rank test. Testing of overall survival was conditional on a statistically significance difference in the primary endpoint of durable response. Success was defined as a p-value ≤ 0.05.||1.00|0.62|0.0511
74033416|NCT00769704|147619649|SUPERIORITY_OR_OTHER||Treatment Difference|20.8|||<|0.0001|TWO_SIDED|95.0|14.4|27.1||Descriptive|Fisher Exact|||||27.1|14.4|<0.0001
74033417|NCT00769704|147619650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0868|TWO_SIDED|95.0|0.14|1.18||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer average duration of response for talimogene laherparepvec relative to GM-CSF.|||1.18|0.14|0.0868
74033418|NCT00769704|147619651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.202|TWO_SIDED|95.0|0.3|1.3||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \> 1.0 indicates a a higher average response onset rate for talimogene laherparepvec relative to GM-CSF.|||1.30|0.30|0.2020
74033419|NCT00769704|147619652|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.32|0.54||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer average time to treatment failure for talimogene laherparepvec relative to GM-CSF.|||0.54|0.32|<0.0001
74033420|NCT00769704|147619653|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.005|TWO_SIDED|95.0|0.13|0.73||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer response interval for talimogene laherparepvec relative to GM-CSF.|||0.73|0.13|0.0050
74033421|NCT04346628|147619670|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.24|TWO_SIDED|95.0|0.48|1.2||The final test was performed at the alpha = 0.04999 level of significance, adjusted for age group and sex.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|||1.20|0.48|0.24
74033422|NCT04346628|147619672|SUPERIORITY|||||||0.06||||||A p-value of 0.05 would have been considered statistically significant.|Fisher Exact|||Difference in hospitalizations||||0.06
73954123|NCT02373813|147442908|SUPERIORITY||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|7.4||0.12|TWO_SIDED|95.0|-2.1|27.0||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 36||27.0|-2.1|0.12
73954124|NCT02373813|147442908|SUPERIORITY||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|5.6||0.4|TWO_SIDED|95.0|-5.2|16.8||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 36||16.8|-5.2|0.40
73954125|NCT02373813|147442908|SUPERIORITY||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|7.7||0.63|TWO_SIDED|95.0|-9.8|20.4||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||20.4|-9.8|0.63
73954126|NCT02373813|147442908|SUPERIORITY||Risk Difference (RD)|-6.9|STANDARD_ERROR_OF_MEAN|5.7||0.31|TWO_SIDED|95.0|-18.0|4.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||4.2|-18.0|0.31
73954127|NCT02373813|147442910|SUPERIORITY||||||<|0.001||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||< 0.001
73954128|NCT02373813|147442910|SUPERIORITY||||||<|0.001||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||< 0.001
73954129|NCT02373813|147442911|SUPERIORITY|||||||0.31||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||0.31
73954130|NCT02373813|147442911|SUPERIORITY|||||||0.51||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||0.51
73954131|NCT02373813|147442912|SUPERIORITY||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|14.1||0.58|TWO_SIDED|95.0|-15.2|40.2|||Chi-squared, Corrected|||||40.2|-15.2|0.58
73954132|NCT05176353|147442913|SUPERIORITY|||||||0.86|||||||Z-score test for person-time rates|||||||0.86
73954133|NCT05176353|147442914|SUPERIORITY|||||||0.05|||||||Z-score test for person-time rates|||||||0.05
74089591|NCT01287039|147731915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.1632||0.0919|TWO_SIDED|95.0|-0.597|0.045|||Mixed model repeated measures|||Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, OCS use at enrollment as fixed factors, and covariate for baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.045|-0.597|0.0919
73954134|NCT05176353|147442915|SUPERIORITY|||||||0.59|||||||Kruskal-Wallis|||||||0.59
73954135|NCT05176353|147442916|SUPERIORITY||||||<|0.01|||||||Z-score test for person-time rates|||||||<0.01
73954136|NCT05176353|147442917|SUPERIORITY|||||||0.2|||||||Z-score test for person-time rates|||||||0.20
73954137|NCT05176353|147442918|SUPERIORITY|||||||0.03|||||||Z-score test for person-time rates|||||||0.03
73954138|NCT05176353|147442919|SUPERIORITY||||||<|0.01|||||||Z-score test for person-time rates|||||||<0.01
73954139|NCT05176353|147442920|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||.05
73954140|NCT02403674|147442922|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|3.537|||||TWO_SIDED|95.0|-1.951|9.026|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.026|-1.951|
73954141|NCT02403674|147442923|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-28.3|||<|0.001|TWO_SIDED|95.0|-34.0|-22.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Dizziness difference||-22.5|-34.0|<0.001
73954142|NCT02403674|147442923|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-13.5|||<|0.001|TWO_SIDED|95.0|-19.1|-7.9||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Sleep disorders and disturbances difference||-7.9|-19.1|<0.001
73954143|NCT02403674|147442923|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-3.8||||0.033|TWO_SIDED|95.0|-7.6|-0.3||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Altered sensorium difference||-0.3|-7.6|0.033
73954144|NCT02403674|147442924|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10|Difference in percentages|3.815|||||TWO_SIDED|95.0|-2.412|10.042|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||10.042|-2.412|
73954145|NCT02403674|147442925|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|4.1|||||TWO_SIDED|95.0|-1.5|9.7|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.7|-1.5|
73954146|NCT02403674|147442926|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10|Difference in percentages|3.268|||||TWO_SIDED|95.0|-3.057|9.593|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.593|-3.057|
73954147|NCT02403674|147442927|SUPERIORITY|Superiority was declared when group difference (MK-1439A-ATRIPLA®) was a positive value.|Difference in mean %change from baseline|10.1|||||TWO_SIDED|95.0|-16.1|36.3|||||95% CIs were calculated based on t-distribution.|||36.3|-16.1|
73954148|NCT02403674|147442928|SUPERIORITY|Superiority was declared when group difference (MK-1439A-ATRIPLA) was a positive value|Diff in mean % change from baseline|14.7|||||TWO_SIDED|95.0|-18.7|48.2|||||The 95% CI for mean difference in CD4 change was based on t-distribution.|||48.2|-18.7|
73954149|NCT02403674|147442929|OTHER|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-8.0|||||TWO_SIDED|95.0|-13.0|-3.1|||||95% CIs were calculated with the Miettinen \& Nurminen method.|||-3.1|-13.0|
73954150|NCT02403674|147442930|OTHER|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-3.6|||||TWO_SIDED|95.0|-6.9|-0.5|||||95% CIs were calculated with the Miettinen \& Nurminen method.|||-0.5|-6.9|
73981111|NCT02978183|147507647|SUPERIORITY|||||||0.0882||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0882
74089592|NCT01287039|147731916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.466|STANDARD_ERROR_OF_MEAN|0.0244|<|0.0001|TWO_SIDED|95.0|-0.514|-0.418|||Mixed model repeated measures|||"Eosinophil Count Over 16 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."||-0.418|-0.514|<0.0001
74089593|NCT01287039|147731916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.455|STANDARD_ERROR_OF_MEAN|0.0182|<|0.0001|TWO_SIDED|95.0|-0.491|-0.419|||Mixed model repeated measures|||"Eosinophil Count Over 52 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."||-0.419|-0.491|<0.0001
73954151|NCT02403674|147442931|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-2.5|||<|0.001|TWO_SIDED|95.0|-5.9|0.8||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Depression and suicide/self-injury difference||0.8|-5.9|<0.001
73954152|NCT02403674|147442931|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-2.5|0.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Psychosis and psychotic disorders difference||0.5|-2.5|<0.001
73954153|NCT02403674|147442932|SUPERIORITY||Difference in mean %change from baseline|-10.01|||<|0.0001|TWO_SIDED|95.0|-13.53|-6.49|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-6.49|-13.53|<0.0001
73954154|NCT02403674|147442933|SUPERIORITY||Difference in mean %change from baseline|-17.02|||<|0.0001|TWO_SIDED|95.0|-20.89|-13.16|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-13.16|-20.89|<0.0001
74089594|NCT01287039|147731918|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.4499|||<|0.0001|TWO_SIDED|95.0|0.3255|0.622||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.6220|0.3255|<0.0001
74089595|NCT01287039|147731918|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.6595||||0.2572|TWO_SIDED|95.0|0.321|1.355||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.3550|0.3210|0.2572
74089596|NCT00474851|147731960|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||p (within group for subjects receiving norethindrone + conjugated estrogens)=0.05 p (within group for subjects receiving norethindrone + placebo)=0.65 p (between the two groups)=0.10|RMANOVA|||"Analysis followed the intention-to-treat principle. The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."||||0.10
73954155|NCT02403674|147442934|SUPERIORITY||Difference in mean %change from baseline|-23.44|||||TWO_SIDED|95.0|-27.57|-19.32|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-19.32|-27.57|
73954156|NCT02403674|147442935|SUPERIORITY||Difference in mean %change from baseline|-35.96|||||TWO_SIDED|95.0|-47.1|-24.82|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-24.82|-47.10|
73954157|NCT02403674|147442936|SUPERIORITY||Difference in mean %change from baseline|-6.47|||||TWO_SIDED|95.0|-7.97|-4.96|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-4.96|-7.97|
73981112|NCT02978183|147507647|SUPERIORITY|||||||0.8032||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 5 Minutes Post-CAC||||0.8032
73981113|NCT02978183|147507647|SUPERIORITY|||||||0.9003||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 7 Minutes Post-CAC||||0.9003
73981114|NCT02978183|147507647|SUPERIORITY|||||||0.9523||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9523
73981115|NCT02978183|147507647|SUPERIORITY|||||||0.9071||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.9071
73981116|NCT02978183|147507647|SUPERIORITY|||||||0.7509||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7509
73981117|NCT02978183|147507647|SUPERIORITY|||||||0.2824||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.2824
73981118|NCT02978183|147507647|SUPERIORITY|||||||0.4017||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.4017
73981119|NCT02978183|147507647|SUPERIORITY|||||||0.4497||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.4497
73981120|NCT02978183|147507647|SUPERIORITY|||||||0.165||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.1650
73981121|NCT02978183|147507647|SUPERIORITY|||||||0.3494||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 5 Minutes Post-CAC||||0.3494
74089597|NCT00474851|147731961|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||p (within group for participants receiving norethindrone + estrogens)=0.0001 p (within group for participants receiving norethindrone + placebo)=0.31 p (between groups)=0.02|RMANOVA|||"The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."||||0.02
73981122|NCT02978183|147507647|SUPERIORITY|||||||0.4781||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 7 Minutes Post-CAC||||0.4781
73981123|NCT02978183|147507647|SUPERIORITY|||||||0.9847||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.9847
73981124|NCT02978183|147507647|SUPERIORITY|||||||0.9731||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.9731
73981125|NCT02978183|147507647|SUPERIORITY|||||||0.6984||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.6984
73981126|NCT02978183|147507647|SUPERIORITY|||||||0.6265||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.6265
73981127|NCT02978183|147507647|SUPERIORITY|||||||0.7848||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.7848
73981128|NCT02978183|147507647|SUPERIORITY|||||||0.5789||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.5789
73981129|NCT02978183|147507648|SUPERIORITY|||||||0.8165||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.8165
73981130|NCT02978183|147507648|SUPERIORITY|||||||0.659||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.6590
73981131|NCT02978183|147507648|SUPERIORITY|||||||0.7455||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.7455
73981132|NCT02978183|147507648|SUPERIORITY|||||||0.9212||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.9212
73981133|NCT02978183|147507648|SUPERIORITY|||||||0.9509||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.9509
73981134|NCT02978183|147507648|SUPERIORITY|||||||0.7897||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.7897
73981135|NCT02978183|147507648|SUPERIORITY|||||||0.3183||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.3183
73981136|NCT02978183|147507648|SUPERIORITY|||||||0.7604||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.7604
73981137|NCT02978183|147507648|SUPERIORITY|||||||0.7343||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7343
73981138|NCT02978183|147507648|SUPERIORITY|||||||0.153||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.1530
73981139|NCT02978183|147507648|SUPERIORITY|||||||0.3307||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.3307
73981140|NCT02978183|147507648|SUPERIORITY|||||||0.3399||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.3399
73981141|NCT02978183|147507648|SUPERIORITY|||||||0.5137||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.5137
73981142|NCT02978183|147507648|SUPERIORITY|||||||0.9962||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.9962
73981143|NCT02978183|147507649|SUPERIORITY|||||||0.3259||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.3259
73981144|NCT02978183|147507649|SUPERIORITY|||||||0.9785||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9785
73981145|NCT02978183|147507649|SUPERIORITY|||||||0.5112||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.5112
73981146|NCT02978183|147507649|SUPERIORITY|||||||0.7771||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7771
73981147|NCT02978183|147507649|SUPERIORITY|||||||0.6232||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.6232
73981148|NCT02978183|147507649|SUPERIORITY|||||||0.8895||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.8895
73981149|NCT02978183|147507649|SUPERIORITY|||||||0.8974||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.8974
73981150|NCT02978183|147507649|SUPERIORITY|||||||0.9604||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.9604
73981151|NCT02978183|147507649|SUPERIORITY|||||||0.5301||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 minutes Post-CAC||||0.5301
73981152|NCT02978183|147507649|SUPERIORITY|||||||0.0386||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.0386
73981153|NCT02978183|147507649|SUPERIORITY|||||||0.1034||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.1034
73981154|NCT02978183|147507649|SUPERIORITY|||||||0.0985||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.0985
73981155|NCT02978183|147507649|SUPERIORITY|||||||0.2342||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.2342
73981156|NCT02978183|147507649|SUPERIORITY|||||||0.3016||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.3016
73981157|NCT02978183|147507650|SUPERIORITY|||||||0.4927||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.4927
73981158|NCT02978183|147507650|SUPERIORITY|||||||0.8686||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.8686
73981159|NCT02978183|147507650|SUPERIORITY|||||||0.5772||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.5772
73981160|NCT02978183|147507650|SUPERIORITY|||||||0.97||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.9700
73981161|NCT02978183|147507650|SUPERIORITY|||||||0.7516||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.7516
73981162|NCT02978183|147507650|SUPERIORITY|||||||0.9532||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.9532
73981163|NCT02978183|147507650|SUPERIORITY|||||||0.7522||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.7522
73873607|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
73981164|NCT02978183|147507650|SUPERIORITY|||||||0.6804||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.6804
73981165|NCT02978183|147507650|SUPERIORITY|||||||0.6267||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.6267
73981166|NCT02978183|147507650|SUPERIORITY|||||||0.0976||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.0976
73981167|NCT02978183|147507650|SUPERIORITY|||||||0.4687|||||||ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.4687
73981168|NCT02978183|147507650|SUPERIORITY|||||||0.0421||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.0421
73981169|NCT02978183|147507650|SUPERIORITY|||||||0.6085||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.6085
73873608|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
73873609|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
73873610|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
73981170|NCT02978183|147507650|SUPERIORITY|||||||0.9634||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.9634
73981171|NCT02978183|147507651|SUPERIORITY|||||||0.3322||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.3322
73981172|NCT02978183|147507651|SUPERIORITY|||||||0.8026||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Pre-CAC||||0.8026
73981173|NCT02978183|147507651|SUPERIORITY|||||||0.9981||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Pre-CAC||||0.9981
73981174|NCT02978183|147507651|SUPERIORITY|||||||0.5645||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.5645
73981175|NCT02978183|147507651|SUPERIORITY|||||||0.5455||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5455
73981176|NCT02978183|147507651|SUPERIORITY|||||||0.698||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6980
73981177|NCT02978183|147507651|SUPERIORITY|||||||0.6115||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.6115
73981178|NCT02978183|147507651|SUPERIORITY|||||||0.4528||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.4528
73981179|NCT02978183|147507651|SUPERIORITY|||||||0.7551||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7551
73981180|NCT02978183|147507651|SUPERIORITY|||||||0.5318||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.5318
73873611|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73954158|NCT01161160|147442966|NON_INFERIORITY|Equivalence criteria were fulfilled if the 2-sided 95% confidence limits on the geometric mean titer (GMT) ratio was within the interval 0.5 to 2.0.|Adjusted GMT ratio|0.96|||||TWO_SIDED|95.0|0.73|1.26||||||To demonstrate the immunological equivalence of HA antigen adjuvanted with AS03B manufactured in Quebec (Arepanrix™) and HA antigen adjuvanted with AS03B manufactured in Dresden (Pandemrix™), 21 days after vaccination.||1.26|0.73|
73954159|NCT00495469|147443032|OTHER|Tukey's trend test for dose response||||||0.003||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||||||0.003
73954160|NCT00495469|147443032|OTHER|Tukey's trend test for dose response||||||0.047||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.047
73954161|NCT00495469|147443032|OTHER|Tukey's trend test for dose response||||||0.006||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.006
73954162|NCT00495469|147443032|OTHER|Tukey's trend test for dose response||||||0.085||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.085
73954163|NCT00495469|147443032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.085|TWO_SIDED|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.05|-0.73|0.085
73954164|NCT00495469|147443032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.006|TWO_SIDED|95.0|-0.95|-0.16||Pairwise comparison included for informational purposes and not controlled for multiplicity|ANCOVA|Change=Baseline+Treatment||||-0.16|-0.95|0.006
73954165|NCT00495469|147443032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.084|TWO_SIDED|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.05|-0.73|0.084
73981181|NCT02978183|147507651|SUPERIORITY|||||||0.9748||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.9748
73981182|NCT02978183|147507651|SUPERIORITY|||||||0.7706||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.7706
73981183|NCT02978183|147507651|SUPERIORITY|||||||0.3414||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.3414
73981184|NCT02978183|147507651|SUPERIORITY|||||||0.4361||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.4361
73873612|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73954166|NCT00495469|147443032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.001|TWO_SIDED|95.0|-1.05|-0.28||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.28|-1.05|0.001
73954167|NCT00495469|147443032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.003|TWO_SIDED|95.0|-0.97|-0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.20|-0.97|0.003
73954168|NCT00495469|147443032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.337|TWO_SIDED|95.0|-0.58|0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.20|-0.58|0.337
73954169|NCT00495469|147443034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.039|TWO_SIDED|95.0|-1.67|-0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.04|-1.67|0.039
73954170|NCT00495469|147443034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06||||0.013|TWO_SIDED|95.0|-1.89|-0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.23|-1.89|0.013
73954171|NCT00495469|147443034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.131|TWO_SIDED|95.0|-1.46|0.19||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.19|-1.46|0.131
73954172|NCT00495469|147443034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95||||0.023|TWO_SIDED|95.0|-1.77|-0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.13|-1.77|0.023
73981185|NCT02978183|147507652|SUPERIORITY|||||||0.0603||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0603
73981186|NCT02978183|147507652|SUPERIORITY|||||||0.4857||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.4857
73954173|NCT00495469|147443034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.007|TWO_SIDED|95.0|-1.95|-0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.32|-1.95|0.007
73954174|NCT00495469|147443034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.223|TWO_SIDED|95.0|-1.34|0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.32|-1.34|0.223
73954175|NCT00495469|147443035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.1||||0.005|TWO_SIDED|95.0|-40.9|-7.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-7.4|-40.9|0.005
73954176|NCT00495469|147443035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.0|||<|0.001|TWO_SIDED|95.0|-52.5|-17.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-17.4|-52.5|<0.001
73981187|NCT02978183|147507652|SUPERIORITY|||||||0.9815||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.9815
73981188|NCT02978183|147507652|SUPERIORITY|||||||0.6213||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.6213
73981189|NCT02978183|147507652|SUPERIORITY|||||||0.1831||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.1831
73981190|NCT02978183|147507652|SUPERIORITY|||||||0.6489||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6489
73981191|NCT02978183|147507652|SUPERIORITY|||||||0.2622||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.2622
73981192|NCT02978183|147507652|SUPERIORITY|||||||0.2397||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.2397
73981193|NCT02978183|147507652|SUPERIORITY|||||||0.3202||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.3202
73981194|NCT02978183|147507652|SUPERIORITY|||||||0.2663||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.2663
74033423|NCT04346628|147619672|SUPERIORITY|||||||0.56||||||A p-value of 0.05 would have been considered statistically significant.|Fisher Exact|||Difference in ED visits||||0.56
74033424|NCT04346628|147619674|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.43|TWO_SIDED|95.0|0.54|1.29||A p-value of 0.05 would have been considered statistically significant.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|Difference in days until initial resolution of symptoms||1.29|0.54|0.43
74033425|NCT04346628|147619674|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.59|TWO_SIDED|95.0|0.52|1.45||A p-value of 0.05 would have been considered statistically significant.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|Difference in days until sustained resolution of symptoms||1.45|0.52|0.59
74033426|NCT03161938|147619678|SUPERIORITY||Odds Ratio (OR)|0.508||||0.248|TWO_SIDED|95.0|0.159|1.62|||Chi-squared, Corrected|||Null hypothesis: Patients receiving 48 mg of preoperative dexamethasone have less postoperative pain. Power calculation: Acute pain is reduced from 70% to 35% for patients receiving 48 mg of dexamathesone, 80% power, 0.05 statistical significance level.||1.620|0.159|0.248
74033427|NCT03161938|147619679|SUPERIORITY|||||||0.519|||||||Wilcoxon (Mann-Whitney)|||||||0.519
74033428|NCT03161938|147619680|SUPERIORITY|||||||0.468|||||||Wilcoxon (Mann-Whitney)|||||||0.468
74033429|NCT03161938|147619681|SUPERIORITY|||||||0.913|||||||Wilcoxon (Mann-Whitney)|||Maximal pain||||0.913
74033430|NCT03161938|147619681|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||Average pain||||0.722
74033431|NCT03161938|147619682|SUPERIORITY||Odds Ratio (OR)|1.19||||0.768|TWO_SIDED|95.0|0.374|3.793|||Chi-squared, Corrected|||||3.793|0.374|0.768
74033432|NCT03161938|147619683|SUPERIORITY|||||||0.133|||||||Regression, Linear|||||||0.133
74033433|NCT03161938|147619684|SUPERIORITY|||||||0.768||||||Not adjusted for multiple comparisons, statistical level of significance 0.01 (bonferroni correction)|Chi-squared, Corrected|||Day 0||||0.768
74033434|NCT03161938|147619684|SUPERIORITY|||||||0.376|||||||Chi-squared, Corrected|||Day 1||||0.376
74033435|NCT03161938|147619684|SUPERIORITY|||||||0.59|||||||Chi-squared, Corrected|||Day 2||||0.590
74033436|NCT03161938|147619684|SUPERIORITY|||||||0.32|||||||Chi-squared, Corrected|||Day 3||||0.320
74033437|NCT03161938|147619684|SUPERIORITY|||||||0.666|||||||Chi-squared, Corrected|||day 4||||0.666
74033438|NCT03161938|147619685|SUPERIORITY||||||>|0.999|||||||Chi-squared, Corrected|||day 0||||>0.999
74033439|NCT03161938|147619685|SUPERIORITY|||||||0.154|||||||Chi-squared, Corrected|||day 1||||0.154
74033440|NCT03161938|147619685|SUPERIORITY|||||||0.447|||||||Chi-squared, Corrected|||day 2||||0.447
74033441|NCT03161938|147619685|SUPERIORITY|||||||0.678|||||||Chi-squared, Corrected|||day 3||||0.678
74033442|NCT03161938|147619685|SUPERIORITY|||||||0.604|||||||Chi-squared, Corrected|||day 4||||0.604
74033443|NCT03161938|147619686|SUPERIORITY|||||||0.075|||||||Chi-squared, Corrected|||day 0, sadness||||0.075
74033444|NCT03161938|147619686|SUPERIORITY|||||||0.447|||||||Chi-squared, Corrected|||day 0, restlessness||||0.447
74033445|NCT03161938|147619686|SUPERIORITY|||||||0.703|||||||Chi-squared, Corrected|||Day 0, fatigue||||0.703
74033446|NCT03161938|147619686|SUPERIORITY|||||||0.731|||||||Chi-squared, Corrected|||Day 1, sadness||||0.731
74033447|NCT03161938|147619686|SUPERIORITY|||||||0.052|||||||Chi-squared, Corrected|||Day 1, restlessness||||0.052
74033448|NCT03161938|147619686|SUPERIORITY|||||||0.807|||||||Chi-squared, Corrected|||Day 1, fatigue||||0.807
74033449|NCT03161938|147619686|SUPERIORITY|||||||0.371|||||||Chi-squared, Corrected|||Day 2, sadness||||0.371
74033450|NCT03161938|147619686|SUPERIORITY|||||||0.064|||||||Chi-squared, Corrected|||Day 2, restlessness||||0.064
74033451|NCT03161938|147619686|SUPERIORITY|||||||0.11|||||||Chi-squared, Corrected|||day 2, fatigue||||0.110
74033452|NCT03161938|147619686|SUPERIORITY|||||||0.531|||||||Chi-squared, Corrected|||Day 3, sadness||||0.531
74033453|NCT03161938|147619686|SUPERIORITY|||||||0.954|||||||Chi-squared, Corrected|||Day 3, restlessness||||0.954
74033454|NCT03161938|147619686|SUPERIORITY|||||||0.526|||||||Chi-squared, Corrected|||Day 3, fatigue||||0.526
74033455|NCT03161938|147619686|SUPERIORITY|||||||0.491|||||||Chi-squared, Corrected|||Day 4, sadness||||0.491
74033456|NCT03161938|147619686|SUPERIORITY|||||||0.042|||||||Chi-squared, Corrected|||Day 4, restlessness||||0.042
74033457|NCT03161938|147619686|SUPERIORITY|||||||0.097|||||||Chi-squared, Corrected|||Day 4, fatigue||||0.097
74033458|NCT03161938|147619687|SUPERIORITY|||||||0.613|||||||Chi-squared, Corrected|||||||0.613
74033459|NCT01533935|147619730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.215|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.315|0.215|<0.0001
74033460|NCT01533935|147619730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.025||0.0015|TWO_SIDED|95.0|0.031|0.129|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.129|0.031|0.0015
74033461|NCT01533935|147619730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.025||0.0005|TWO_SIDED|95.0|0.039|0.137|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.137|0.039|0.0005
74033462|NCT01533935|147619730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.224|0.324|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.324|0.224|<0.0001
74033463|NCT01533935|147619730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.025||0.0004|TWO_SIDED|95.0|0.039|0.138|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.138|0.039|0.0004
74033464|NCT01533935|147619730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.025||0.0001|TWO_SIDED|95.0|0.047|0.147|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.147|0.047|0.0001
74033465|NCT01533935|147619731|SUPERIORITY_OR_OTHER||Ratio|1.134|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|1.065|1.206|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD|||1.206|1.065|<0.0001
73954177|NCT00495469|147443035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.8||||0.001|TWO_SIDED|95.0|-46.9|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-12.7|-46.9|0.001
73954178|NCT00495469|147443035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.5|||<|0.001|TWO_SIDED|95.0|-53.6|-19.5||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-19.5|-53.6|<0.001
73954179|NCT00495469|147443035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.5||||0.001|TWO_SIDED|95.0|-46.3|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-12.7|-46.3|0.001
73954180|NCT00495469|147443035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.8||||0.114|TWO_SIDED|95.0|-31.0|3.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||3.4|-31.0|0.114
73954181|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.757|TWO_SIDED|95.0|0.27|6.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<=6.5%)||6.06|0.27|0.757
73954182|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.58|TWO_SIDED|95.0|0.31|8.01||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<=6.5%)||8.01|0.31|0.580
73954183|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.881|TWO_SIDED|95.0|0.22|5.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<=6.5%)||5.73|0.22|0.881
73954184|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.382|TWO_SIDED|95.0|0.44|8.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<=6.5%)||8.75|0.44|0.382
73954185|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.409|TWO_SIDED|95.0|0.42|8.68||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<=6.5%)||8.68|0.42|0.409
73954186|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.795|TWO_SIDED|95.0|0.24|6.29||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<=6.5%)||6.29|0.24|0.795
73954187|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.765|TWO_SIDED|95.0|0.36|3.95||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7%)||3.95|0.36|0.765
73954188|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.1|TWO_SIDED|95.0|0.82|9.09||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7%)||9.09|0.82|0.100
73954189|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.687|TWO_SIDED|95.0|0.38|4.3||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7%)||4.30|0.38|0.687
73954190|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.409|TWO_SIDED|95.0|0.5|5.52||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7%)||5.52|0.50|0.409
73981195|NCT02978183|147507652|SUPERIORITY|||||||0.5672||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.5672
73954191|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.81||||0.086|TWO_SIDED|95.0|0.86|9.15||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7%)||9.15|0.86|0.086
73954192|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.369|TWO_SIDED|95.0|0.52|5.88||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7%)||5.88|0.52|0.369
73981196|NCT02978183|147507652|SUPERIORITY|||||||0.5055||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.5055
73954193|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.16|TWO_SIDED|95.0|0.74|6.4||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction\>=0.7%)||6.40|0.74|0.160
73954194|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87||||0.014|TWO_SIDED|95.0|1.31|11.42||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction\>=0.7%)||11.42|1.31|0.014
73954195|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.162|TWO_SIDED|95.0|0.73|6.44||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction\>=0.7%)||6.44|0.73|0.162
73954196|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09||||0.011|TWO_SIDED|95.0|1.38|12.17||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction\>=0.7%)||12.17|1.38|0.011
73954197|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.31||||0.003|TWO_SIDED|95.0|1.79|15.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction\>=0.7%)||15.73|1.79|0.003
73954198|NCT00495469|147443036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.264|TWO_SIDED|95.0|0.63|5.49||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction\>=0.7%)||5.49|0.63|0.264
73954199|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.48|TWO_SIDED|95.0|0.46|5.28||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7 mmol/L)||5.28|0.46|0.480
73981197|NCT02978183|147507652|SUPERIORITY|||||||0.8143||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8143
73981198|NCT02978183|147507652|SUPERIORITY|||||||0.6901||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6901
73981199|NCT02978183|147507653|SUPERIORITY|||||||0.4032||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.4032
73981200|NCT02978183|147507653|SUPERIORITY|||||||0.2946||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.2946
73981201|NCT02978183|147507653|SUPERIORITY|||||||0.2863||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.2863
73981202|NCT02978183|147507653|SUPERIORITY|||||||0.0891||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.0891
73981203|NCT02978183|147507653|SUPERIORITY|||||||0.5347||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5347
73873613|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873614|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
73873615|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873616|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.55|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.55
73873617|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
73873618|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
73873619|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
73873620|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73954200|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87||||0.011|TWO_SIDED|95.0|1.44|16.46||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7 mmol/L)||16.46|1.44|0.011
73954201|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.087|TWO_SIDED|95.0|0.85|9.96||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7 mmol/L)||9.96|0.85|0.087
73954202|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.082|TWO_SIDED|95.0|0.87|9.78||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7 mmol/L)||9.78|0.87|0.082
74033466|NCT01533935|147619731|SUPERIORITY_OR_OTHER||Ratio|1.111|STANDARD_ERROR_OF_MEAN|0.035||0.0009|TWO_SIDED|95.0|1.045|1.182|||Mixed Models Analysis||Ratio calculated Tiotropium + olodaterol 5/5 QD as divided by Olodaterol 5 mcg QD|||1.182|1.045|0.0009
73873621|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
73954203|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0||||0.024|TWO_SIDED|95.0|1.2|13.27||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7 mmol/L)||13.27|1.20|0.024
73954204|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.85||||0.012|TWO_SIDED|95.0|1.41|16.66||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7 mmol/L)||16.66|1.41|0.012
73873622|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873623|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873624|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.64|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.64
73873625|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
73873626|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
73954205|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.27|TWO_SIDED|95.0|0.62|5.54||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7.8 mmol/L)||5.54|0.62|0.270
73954206|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.18||||0.043|TWO_SIDED|95.0|1.04|9.72||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7.8 mmol/L)||9.72|1.04|0.043
73954207|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.169|TWO_SIDED|95.0|0.72|6.53||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7.8 mmol/L)||6.53|0.72|0.169
73954208|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12||||0.042|TWO_SIDED|95.0|1.04|9.36||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7.8 mmol/L)||9.36|1.04|0.042
73873627|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873628|NCT01128426|147289449|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873629|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
73873630|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
73954209|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69||||0.02|TWO_SIDED|95.0|1.23|11.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7.8 mmol/L)||11.06|1.23|0.020
74033467|NCT01533935|147619731|SUPERIORITY_OR_OTHER||Ratio|1.043|STANDARD_ERROR_OF_MEAN|0.033||0.1807|TWO_SIDED|95.0|0.981|1.109|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD|||1.109|0.981|0.1807
73954210|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.211|TWO_SIDED|95.0|0.67|6.24||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7.8 mmol/L)||6.24|0.67|0.211
74033468|NCT01533935|147619731|SUPERIORITY_OR_OTHER||Ratio|1.121|STANDARD_ERROR_OF_MEAN|0.036||0.0003|TWO_SIDED|95.0|1.054|1.193|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD|||1.193|1.054|0.0003
73954211|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.179|TWO_SIDED|95.0|0.61|13.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction \>=1.7 mmol/L)||13.75|0.61|0.179
73954212|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.93||||0.03|TWO_SIDED|95.0|1.17|20.87||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction \>=1.7 mmol/L)||20.87|1.17|0.030
73954213|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99||||0.142|TWO_SIDED|95.0|0.69|12.86||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (reduction \>=1.7 mmol/L)||12.86|0.69|0.142
73954214|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.21||||0.012|TWO_SIDED|95.0|1.49|25.83||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction \>=1.7 mmol/L)||25.83|1.49|0.012
73954215|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.01|||<|0.001|TWO_SIDED|95.0|3.14|54.0||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction \>=1.7 mmol/L)||54.00|3.14|<0.001
73954216|NCT00495469|147443037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.6||||0.01|TWO_SIDED|95.0|1.56|27.99||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction \>=1.7 mmol/L)||27.99|1.56|0.010
73954217|NCT00495469|147443038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.318|TWO_SIDED|95.0|-0.19|0.59||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.59|-0.19|0.318
73954218|NCT00495469|147443038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.131|TWO_SIDED|95.0|-0.73|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.10|-0.73|0.131
74033469|NCT01533935|147619731|SUPERIORITY_OR_OTHER||Ratio|1.099|STANDARD_ERROR_OF_MEAN|0.035||0.0029|TWO_SIDED|95.0|1.033|1.17|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD|||1.170|1.033|0.0029
73954219|NCT00495469|147443038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.452|TWO_SIDED|95.0|-0.54|0.24||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.24|-0.54|0.452
73954220|NCT00495469|147443038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.845|TWO_SIDED|95.0|-0.44|0.36||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.36|-0.44|0.845
73954221|NCT00495469|147443038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.393|TWO_SIDED|95.0|-0.58|0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.23|-0.58|0.393
73954222|NCT00495469|147443038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.072|TWO_SIDED|95.0|-0.76|0.03||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.03|-0.76|0.072
73954223|NCT00495469|147443039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.767|TWO_SIDED|95.0|-0.4|0.3||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.30|-0.40|0.767
73954224|NCT00495469|147443039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.604|TWO_SIDED|95.0|-0.46|0.27||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.27|-0.46|0.604
73954225|NCT00495469|147443039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.483|TWO_SIDED|95.0|-0.23|0.48||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.48|-0.23|0.483
73954226|NCT00495469|147443039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.956|TWO_SIDED|95.0|-0.35|0.37||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.37|-0.35|0.956
73954227|NCT00495469|147443039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.185|TWO_SIDED|95.0|-0.12|0.6||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.60|-0.12|0.185
73954228|NCT00495469|147443039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.863|TWO_SIDED|95.0|-0.32|0.39||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.39|-0.32|0.863
73954229|NCT00495469|147443040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.348|TWO_SIDED|95.0|-0.46|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.16|-0.46|0.348
73954230|NCT00495469|147443040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.952|TWO_SIDED|95.0|-0.33|0.31||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.31|-0.33|0.952
73954231|NCT00495469|147443040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.523|TWO_SIDED|95.0|-0.21|0.42||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.42|-0.21|0.523
73954232|NCT00495469|147443040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.889|TWO_SIDED|95.0|-0.34|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.29|-0.34|0.889
73954233|NCT00495469|147443040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.124|TWO_SIDED|95.0|-0.07|0.56||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.56|-0.07|0.124
73954234|NCT00495469|147443040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.581|TWO_SIDED|95.0|-0.22|0.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.40|-0.22|0.581
74033470|NCT01533935|147619731|SUPERIORITY_OR_OTHER||Ratio|1.032|STANDARD_ERROR_OF_MEAN|0.033||0.324|TWO_SIDED|95.0|0.97|1.098|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD|||1.098|0.970|0.3240
73954235|NCT00495469|147443041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.518|TWO_SIDED|95.0|-0.05|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.10|-0.05|0.518
73954236|NCT00495469|147443041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.352|TWO_SIDED|95.0|-0.04|0.11||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.11|-0.04|0.352
73954237|NCT00495469|147443041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.026|TWO_SIDED|95.0|0.01|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.16|0.01|0.026
73954238|NCT00495469|147443041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.069|TWO_SIDED|95.0|-0.01|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.14|-0.01|0.069
73954239|NCT00495469|147443041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.154|TWO_SIDED|95.0|-0.02|0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.13|-0.02|0.154
73954240|NCT00495469|147443041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.005|TWO_SIDED|95.0|0.03|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.18|0.03|0.005
73954241|NCT00495469|147443042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.143|TWO_SIDED|95.0|-0.58|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-0.58|0.143
73954242|NCT00495469|147443042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.495|TWO_SIDED|95.0|-0.46|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.22|-0.46|0.495
73954243|NCT00495469|147443042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.261|TWO_SIDED|95.0|-0.52|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.14|-0.52|0.261
73954244|NCT00495469|147443042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.446|TWO_SIDED|95.0|-0.46|0.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.20|-0.46|0.446
73981204|NCT02978183|147507653|SUPERIORITY|||||||0.3733||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.3733
73981205|NCT02978183|147507653|SUPERIORITY|||||||0.2506||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.2506
73981206|NCT02978183|147507653|SUPERIORITY|||||||0.8667||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.8667
74033471|NCT01533935|147619732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.004|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||-0.002|-0.004|<0.0001
73981207|NCT02978183|147507653|SUPERIORITY|||||||0.764||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7640
73981208|NCT02978183|147507653|SUPERIORITY|||||||0.8008||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.8008
73981209|NCT02978183|147507653|SUPERIORITY|||||||0.4729||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.4729
73981210|NCT02978183|147507653|SUPERIORITY|||||||0.4742||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.4742
73981211|NCT02978183|147507653|SUPERIORITY|||||||0.2922||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.2922
73981212|NCT02978183|147507653|SUPERIORITY|||||||0.3657||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.3657
73954245|NCT00495469|147443042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.783|TWO_SIDED|95.0|-0.29|0.38||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.38|-0.29|0.783
73954246|NCT00495469|147443042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.454|TWO_SIDED|95.0|-0.46|0.21||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.21|-0.46|0.454
73954247|NCT00495469|147443043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.363|TWO_SIDED|95.0|-0.59|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.22|-0.59|0.363
73954248|NCT00495469|147443043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.111|TWO_SIDED|95.0|-0.76|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-0.76|0.111
73954249|NCT00495469|147443043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.08|TWO_SIDED|95.0|-0.77|0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.04|-0.77|0.080
73954250|NCT00495469|147443043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.267|TWO_SIDED|95.0|-0.64|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.18|-0.64|0.267
73954251|NCT00495469|147443043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.549|TWO_SIDED|95.0|-0.54|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.29|-0.54|0.549
73954252|NCT00495469|147443043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.056|TWO_SIDED|95.0|-0.81|0.01||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.01|-0.81|0.056
73954253|NCT00495469|147443044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.396|TWO_SIDED|95.0|-1.65|0.66||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.66|-1.65|0.396
73954254|NCT00495469|147443044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51||||0.013|TWO_SIDED|95.0|-2.7|-0.33||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.33|-2.70|0.013
73954255|NCT00495469|147443044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.44||||0.017|TWO_SIDED|95.0|-2.61|-0.26||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.26|-2.61|0.017
73981213|NCT02978183|147507654|SUPERIORITY|||||||0.66||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.6600
73981214|NCT02978183|147507654|SUPERIORITY|||||||0.6877||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.6877
73981215|NCT02978183|147507654|SUPERIORITY|||||||0.334||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.3340
73981216|NCT02978183|147507654|SUPERIORITY|||||||0.7874||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7874
73981217|NCT02978183|147507654|SUPERIORITY|||||||0.3812||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.3812
73954256|NCT00495469|147443044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.45||||0.015|TWO_SIDED|95.0|-2.61|-0.28||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.28|-2.61|0.015
73954257|NCT00495469|147443044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.069|TWO_SIDED|95.0|-2.26|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-2.26|0.069
73954258|NCT00495469|147443044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03||||0.086|TWO_SIDED|95.0|-0.15|2.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||2.20|-0.15|0.086
73981218|NCT02978183|147507654|SUPERIORITY|||||||0.6987|||||||ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6987
73981219|NCT02978183|147507654|SUPERIORITY|||||||0.6832||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.6832
73981220|NCT02978183|147507654|SUPERIORITY|||||||0.8521||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.8521
73981221|NCT02978183|147507654|SUPERIORITY|||||||0.7516||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7516
73981222|NCT02978183|147507654|SUPERIORITY|||||||0.6252||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.6252
73981223|NCT02978183|147507654|SUPERIORITY|||||||0.8321||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.8321
73981224|NCT02978183|147507654|SUPERIORITY|||||||0.8173||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.8173
73981225|NCT02978183|147507654|SUPERIORITY|||||||0.5445||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.5445
73981226|NCT02978183|147507654|SUPERIORITY|||||||0.681||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6810
73981227|NCT02978183|147507655|SUPERIORITY|||||||0.0111||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0111
73981228|NCT02978183|147507655|SUPERIORITY|||||||0.3391||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.3391
73954259|NCT03815916|147443073|SUPERIORITY||Mean Difference (Final Values)|0.3865||||0.1077|TWO_SIDED||||||t-test, 2 sided|||The primary efficacy endpoint is the mean change in the average NAD+/NADH brain ratio from baseline to Week 12 using a partial volume coil 31P-MRS data on the Per Protocol Treatment Population. A paired t-test will be used to analyze the mean change from baseline.||||0.1077
73981229|NCT02978183|147507655|SUPERIORITY|||||||0.239||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.2390
74033472|NCT01533935|147619732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0033|TWO_SIDED|95.0|-0.003|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||-0.001|-0.003|0.0033
73981230|NCT02978183|147507655|SUPERIORITY|||||||0.3068||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.3068
73981231|NCT02978183|147507655|SUPERIORITY|||||||0.4914||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.4914
73981232|NCT02978183|147507655|SUPERIORITY|||||||0.5185||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.5185
73981233|NCT02978183|147507655|SUPERIORITY|||||||0.5262||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.5262
73981234|NCT02978183|147507655|SUPERIORITY|||||||0.6098||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.6098
73981235|NCT02978183|147507655|SUPERIORITY|||||||0.8849||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.8849
73981236|NCT02978183|147507655|SUPERIORITY|||||||0.6941||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.6941
73981237|NCT02978183|147507655|SUPERIORITY|||||||0.5728||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.5728
73981238|NCT02978183|147507655|SUPERIORITY|||||||0.5931||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.5931
73981239|NCT02978183|147507655|SUPERIORITY|||||||0.7513||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.7513
73981240|NCT02978183|147507655|SUPERIORITY|||||||0.7297||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.7297
73981241|NCT02978183|147507656|SUPERIORITY|||||||0.1259||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.1259
73981242|NCT02978183|147507656|SUPERIORITY|||||||0.9234||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9234
73981243|NCT02978183|147507656|SUPERIORITY|||||||0.8816||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.8816
73981244|NCT02978183|147507656|SUPERIORITY|||||||0.5703||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.5703
73981245|NCT02978183|147507656|SUPERIORITY|||||||0.5428||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5428
73981246|NCT02978183|147507656|SUPERIORITY|||||||0.7454||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.7454
73981247|NCT02978183|147507656|SUPERIORITY|||||||0.8195||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.8195
73981248|NCT02978183|147507656|SUPERIORITY|||||||0.0909||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.0909
73981249|NCT02978183|147507656|SUPERIORITY|||||||0.4881||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.4881
73981250|NCT02978183|147507656|SUPERIORITY|||||||0.3391||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.3391
73981251|NCT02978183|147507656|SUPERIORITY|||||||0.6065||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.6065
73981252|NCT02978183|147507656|SUPERIORITY|||||||0.3393||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.3393
73954260|NCT00755755|147443132|SUPERIORITY_OR_OTHER||Difference in proportions|72.7|||<|0.001|TWO_SIDED|95.0|55.1|83.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)|||83.2|55.1|<0.001
73873631|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method.The null hypothesis was relative risk = 1.||||0.13
73981253|NCT02978183|147507656|SUPERIORITY|||||||0.8364||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8364
73981254|NCT02978183|147507656|SUPERIORITY|||||||0.8858||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.8858
73981255|NCT02978183|147507657|SUPERIORITY|||||||0.8818||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.8818
73981256|NCT02978183|147507657|SUPERIORITY|||||||0.8679||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.8679
73981257|NCT02978183|147507657|SUPERIORITY|||||||0.7856||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.7856
73981258|NCT02978183|147507657|SUPERIORITY|||||||0.7507||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7507
73981259|NCT02978183|147507657|SUPERIORITY|||||||0.8189||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.8189
73981260|NCT02978183|147507657|SUPERIORITY|||||||0.9206||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.9206
73981261|NCT02978183|147507657|SUPERIORITY|||||||0.9591||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.9591
73981262|NCT02978183|147507657|SUPERIORITY|||||||0.5302||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.5302
73981263|NCT02978183|147507657|SUPERIORITY|||||||0.7591||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7591
73981264|NCT02978183|147507657|SUPERIORITY|||||||0.8978||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.8978
73981265|NCT02978183|147507657|SUPERIORITY|||||||0.7179||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.7179
73981266|NCT02978183|147507657|SUPERIORITY|||||||0.7262||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.7262
73981267|NCT02978183|147507657|SUPERIORITY|||||||0.8275||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8275
73981268|NCT02978183|147507657|SUPERIORITY|||||||0.618||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6180
73981269|NCT02978183|147507658|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity were not employed|Fisher Exact|||Day 7: 10 minutes post-CAC||||>0.9999
73981270|NCT02978183|147507658|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 15 minutes post-CAC||||>0.9999
73981271|NCT02978183|147507658|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 20 minutes post-CAC||||>0.9999
73981272|NCT02978183|147507658|SUPERIORITY|||||||0.7312||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 25 minutes post-CAC||||0.7312
73981273|NCT02978183|147507658|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 30 minutes post-CAC||||>0.9999
73981274|NCT02978183|147507658|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 10 minutes post-CAC||||>0.9999
73981275|NCT02978183|147507658|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 15 minutes post-CAC||||>0.9999
73981276|NCT02978183|147507658|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 20 minutes post-CAC||||>0.9999
73981277|NCT02978183|147507658|SUPERIORITY|||||||0.4297||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 25 minutes post-CAC||||0.4297
73981278|NCT02978183|147507658|SUPERIORITY|||||||0.4791||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 30 minutes post-CAC||||0.4791
73981279|NCT02158806|147507672|SUPERIORITY|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Cox Proportional Hazard|0.85|STANDARD_ERROR_OF_MEAN|0.146||0.246|TWO_SIDED|95.0|0.64|1.13|||Log Rank||Placebo group = reference group|Placebo group = reference group||1.13|0.64|0.246
73981280|NCT02158806|147507673|SUPERIORITY|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Risk Ratio (RR)|0.88||||0.073|TWO_SIDED|95.0|0.76|1.01|||Chi-squared|||||1.01|0.76|0.073
73981281|NCT02158806|147507674|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.25|TWO_SIDED|95.0|-1.9|0.5||Adjusted for baseline values.|ANCOVA|One participant in aspirin group had missing data for 24 week endpoint visit; we used the baseline value for imputation.|Placebo group = reference group.|||0.5|-1.9|0.25
73981282|NCT02158806|147507675|SUPERIORITY||Mean Difference (Net)|1.1||||0.714|TWO_SIDED|95.0|-5.0|7.2|||Regression, Linear|Adjusted for baseline values||Change in Physical Functioning||7.2|-5.0|0.714
73981283|NCT02158806|147507675|SUPERIORITY||Mean Difference (Net)|1.4||||0.768|TWO_SIDED|95.0|-8.0|10.8|||Regression, Linear|Adjusted for baseline values||Change in Role Physical||10.8|-8.0|0.768
73981284|NCT02158806|147507675|SUPERIORITY||Mean Difference (Net)|2.3||||0.449|TWO_SIDED|95.0|-3.7|8.4|||Regression, Linear|Adjusted for baseline values||Change in Bodily Pain||8.4|-3.7|0.449
73981285|NCT02158806|147507675|SUPERIORITY||Mean Difference (Net)|-0.3||||0.873|TWO_SIDED|95.0|-4.3|3.6|||Regression, Linear|Adjusted for baseline values||Change in General Health||3.6|-4.3|0.873
73981286|NCT02158806|147507675|SUPERIORITY||Mean Difference (Net)|4.2||||0.057|TWO_SIDED|95.0|-0.1|8.5|||Regression, Linear|Adjusted for baseline values||Change in Vitality||8.5|-0.1|0.057
73981287|NCT02158806|147507675|SUPERIORITY||Mean Difference (Net)|1.0||||0.756|TWO_SIDED|95.0|-5.1|7.0|||Regression, Linear|Adjusted for baseline values||Change in Social Functioning||7.0|-5.1|0.756
73981288|NCT02158806|147507675|SUPERIORITY||Mean Difference (Net)|3.7||||0.4|TWO_SIDED|95.0|-4.9|12.3|||Regression, Linear|Adjusted for baseline values||Change in Role Emotional||12.3|-4.9|0.400
73873632|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
73873633|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
73873634|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
73873635|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873636|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73873637|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873638|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
73954261|NCT00755755|147443132|SUPERIORITY_OR_OTHER||Difference in proportions|73.7|||<|0.001|TWO_SIDED|95.0|56.2|84.0||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)|||84.0|56.2|<0.001
73954262|NCT00755755|147443133|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-22.6||||0.002|TWO_SIDED|95.0|-36.1|-8.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.|||-8.2|-36.1|0.002
73873639|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
73873640|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873641|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873642|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873643|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
73873644|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
73873645|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
73873646|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
73873647|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
73873648|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
73981289|NCT02158806|147507675|SUPERIORITY||Mean Difference (Net)|-2.3||||0.236|TWO_SIDED|95.0|-6.2|1.5|||Regression, Linear|Adjusted for baseline values||Change in Mental Health||1.5|-6.2|0.236
73981290|NCT02158806|147507676|SUPERIORITY||Mean Difference (Net)|3.4||||0.156|TWO_SIDED|95.0|-1.3|8.0||Adjusted for baseline values|Regression, Linear|||||8.0|-1.3|0.156
73981291|NCT02158806|147507677|SUPERIORITY||Mean Difference (Net)|-1.5||||0.438|TWO_SIDED|95.0|-5.2|2.2|||Regression, Linear|Adjusted for baseline values||Change in social function||2.2|-5.2|0.438
73981292|NCT02158806|147507677|SUPERIORITY||Mean Difference (Net)|-1.3||||0.408|TWO_SIDED|95.0|-4.5|1.9|||Regression, Linear|Adjusted for baseline values||Change in domestic activities||1.9|-4.5|0.408
73981293|NCT02158806|147507677|SUPERIORITY||Mean Difference (Net)|-1.3||||0.568|TWO_SIDED|95.0|-5.6|3.1|||Regression, Linear|Adjusted for baseline values||Change in cosmesis||3.1|-5.6|0.568
73981294|NCT02158806|147507677|SUPERIORITY||Mean Difference (Net)|-3.0||||0.257|TWO_SIDED|95.0|-8.1|2.2|||Regression, Linear|Adjusted for baseline values||Change in emotional status||2.2|-8.1|0.257
73981295|NCT02158806|147507677|SUPERIORITY||Mean Difference (Net)|-1.9||||0.273|TWO_SIDED|95.0|-5.2|1.5|||Regression, Linear|Adjusted for baseline values||||1.5|-5.2|0.273
73981296|NCT02158806|147507678|SUPERIORITY||Risk Ratio (RR)|1.01||||0.917|TWO_SIDED|95.0|0.87|1.17|||Chi-squared|||||1.17|0.87|0.917
73873649|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
73981297|NCT02158806|147507679|SUPERIORITY||Incidence Rate Ratio|1.1||||0.71|TWO_SIDED|95.0|0.7|1.7|||IRR test statistic|Incidence Rate Ratio (IRR) test statistic compared to probability of the same obtained from standard normal distribution tables.||||1.7|0.7|0.71
73981298|NCT02340806|147507680|SUPERIORITY|||||||0.67|||||||Chi-squared, Corrected|||||||.67
73981299|NCT02340806|147507681|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
73981300|NCT02340806|147507682|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||.21
73981301|NCT02340806|147507683|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
73981302|NCT02340806|147507684|SUPERIORITY|||||||0.66|||||||Kruskal-Wallis|||||||.66
73873650|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
73873651|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
73981303|NCT02340806|147507686|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||.92
73981304|NCT02340806|147507687|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||.58
73981305|NCT02340806|147507688|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||.67
73981306|NCT02340806|147507689|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||.99
73981307|NCT02340806|147507690|SUPERIORITY|||||||0.37|||||||Kruskal-Wallis|||||||.37
73981308|NCT02591056|147507695|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|t=+7.45; df=26||||||<0.0001
73981309|NCT04520256|147507717|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73981310|NCT04520256|147507718|SUPERIORITY||Estimated Change|-0.27||||0.693|TWO_SIDED|95.0|-0.54|0.01|||Mixed Models Analysis|||||0.01|-.54|0.693
73981311|NCT04520256|147507718|SUPERIORITY||Estimated Change|0.09||||0.9|TWO_SIDED|95.0|0.01|0.18|||Mixed Models Analysis|||||0.18|0.01|0.900
73981312|NCT04520256|147507718|SUPERIORITY||Estimated Change|-0.03||||0.96|TWO_SIDED|95.0|-0.06|0.01|||Mixed Models Analysis|||||0.01|-0.06|0.960
73981313|NCT04520256|147507718|SUPERIORITY||Estimated Change|0.44||||0.113|TWO_SIDED|95.0|0.01|0.88|||Mixed Models Analysis|||||0.88|0.01|0.113
74033473|NCT01533935|147619732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.2306|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.2306
73981314|NCT04520256|147507718|SUPERIORITY||Estimated Change|0.92||||0.187|TWO_SIDED|95.0|0.01|1.84|||Mixed Models Analysis|||||1.84|0.01|0.187
73981315|NCT04520256|147507719|SUPERIORITY|||||||0.999|||||||Mixed Models Analysis|||||||0.999
73981316|NCT04520256|147507720|SUPERIORITY||Estimated Proportion|0.12||||0.999|TWO_SIDED|95.0|0.0|0.56|||Mixed Models Analysis|||||.56|0|.999
73981317|NCT04520256|147507720|SUPERIORITY||Estimated Proportion|0.15||||0.999|TWO_SIDED|95.0|0.0|0.68|||Mixed Models Analysis|||||.68|0|.999
73981318|NCT04520256|147507720|SUPERIORITY||Estimated Proportion|0.11||||0.999|TWO_SIDED|95.0|0.0|0.52|||Mixed Models Analysis|||||.52|0|.999
73981319|NCT04520256|147507720|SUPERIORITY||Estimated Proportion|0.11||||0.999|TWO_SIDED|95.0|0.0|0.5|||Mixed Models Analysis|||||.50|0|.999
73981320|NCT04520256|147507720|SUPERIORITY||Estimated Proportion|0.1||||0.999|TWO_SIDED|95.0|0.0|0.47|||Mixed Models Analysis|||||.47|0|.999
73981321|NCT05492786|147507721|SUPERIORITY|||||||0.517||||||The p-value reported is 2-tailed and based on heteroskedasticity-robust standard errors.|Regression, Linear|||Null hypothesis: there is no difference in flu shots for patients whose clinicians were shown alerts with information about their risk status (patients randomized to the High-risk Alert or High-risk Alert with Risk Factors arms) compared with those whose clinicians were shown the standard alert. Alternative hypothesis: patients in the High-risk Alert and High-risk Alert with Risk Factors arms will exhibit improved flu vaccination rates compared with those in the standard Alert arm.||||0.517
73981322|NCT05492786|147507721|SUPERIORITY|||||||0.226||||||The p-value reported is 2-tailed and based on heteroskedasticity-robust standard errors.|Regression, Linear|||Null hypothesis: there is no difference in flu shots for patients whose clinicians were shown alerts the factors that contributed to a patient's high risk (High-risk Alert with Risk Factors arm) compared with those whose clinicians were shown the alert with risk level only (High-risk Alert arm). Alternative hypothesis: patients in the High-risk Alert with Risk Factors arm will exhibit improved flu vaccination rates compared with those in the High-risk Alert arm.||||0.226
73981323|NCT02221934|147507732|SUPERIORITY||Risk Difference (RD)|0.176||||0.002|TWO_SIDED|95.0|0.07|0.283|||Regression, Logistic||Difference in Responders between groups presented.|||0.283|0.070|0.002
73981324|NCT01072149|147507744|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.233|||<|0.001|TWO_SIDED|95.0|0.179|0.287|||Mixed Models Analysis|||||0.287|0.179|<0.001
73981325|NCT01072149|147507744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|||<|0.001|TWO_SIDED|95.0|0.165|0.275|||Mixed Models Analysis|||||0.275|0.165|<0.001
73981326|NCT01072149|147507744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|||<|0.001|TWO_SIDED|95.0|0.181|0.291|||Mixed Models Analysis|||||0.291|0.181|<0.001
73981327|NCT03386344|147507756|SUPERIORITY||Difference in Least Squares (LS) Means|-0.45|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.649|-0.25|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline HbA1c as a covariate.||-0.250|-0.649|<0.0001
73981328|NCT03386344|147507756|SUPERIORITY||Difference in LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.634|-0.235|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline HbA1c as a covariate.||-0.235|-0.634|<0.0001
73981329|NCT03386344|147507757|SUPERIORITY||Difference in LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.423||0.5707|TWO_SIDED|95.0|-1.07|0.59|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||0.590|-1.070|0.5707
73873652|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
73873653|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
73981330|NCT03386344|147507757|SUPERIORITY||Difference in LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.419||0.7247|TWO_SIDED|95.0|-0.969|0.674|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||0.674|-0.969|0.7247
73954263|NCT00755755|147443133|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-18.2||||0.006|TWO_SIDED|95.0|-33.0|-5.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.|||-5.2|-33.0|0.006
73954264|NCT00083174|147443135|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35||||0.002|TWO_SIDED|95.0|0.18|0.7|||Log Rank|||The null hypothesis was no difference between two groups. The sample size estimate was based on an assumption of annual invasive breast cancer rate of 0.60% in the placebo group and 0.21% in exemestane group, a relative reduction of 65% with exemestane. To detect this with a two-sided 5% level and 90% power, a total of 38 cases of invasive breast cancer were required, projected to occur when 4560 women were randomly assigned in a 3-year period and then followed for an additional 1.2 years.||0.70|0.18|0.002
73954265|NCT00083174|147443136|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.004|TWO_SIDED|95.0|0.27|0.79|||Log Rank|||||0.79|0.27|0.004
73954266|NCT00083174|147443137|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.36||||0.07|TWO_SIDED|95.0|0.11|1.12|||Log Rank|||||1.12|0.11|0.07
73954267|NCT05489224|147443197|EQUIVALENCE|Predefined margin: -0.6 to 0.5|Treatment difference and 90% CI|-0.1|||||TWO_SIDED|90.0|-0.3|0.1|||ANCOVA|ANCOVA with multiple imputation||||0.10|-0.30|
73954268|NCT03194776|147443208|SUPERIORITY||Mean Difference (Final Values)|-17.74|||=|0.2612|TWO_SIDED|80.0|-38.03|2.55||P-value of \<= 0.2 was considered significant.|two-sided test|||Statistical analysis was done by mixed effect model repeat measurement (MMRM) model analysis.||2.55|-38.03|= 0.2612
73954269|NCT00764868|147443216|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks||||||<0.001
73873654|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873655|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73873656|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73981331|NCT03386344|147507758|SUPERIORITY||Difference in LS Means|0.14|STANDARD_ERROR_OF_MEAN|0.308||0.6454|TWO_SIDED|95.0|-0.462|0.745|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline lumbar spine as a covariate.||0.745|-0.462|0.6454
73981332|NCT03386344|147507758|SUPERIORITY||Difference in LS Means|0.19|STANDARD_ERROR_OF_MEAN|0.308||0.5289|TWO_SIDED|95.0|-0.41|0.798|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline lumbar spine as a covariate.||0.798|-0.410|0.5289
74033474|NCT01533935|147619732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||-0.002|-0.005|<0.0001
73873657|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
73981333|NCT03386344|147507759|SUPERIORITY||Difference in LS Means|0.75|STANDARD_ERROR_OF_MEAN|0.462||0.105|TWO_SIDED|95.0|-0.157|1.654|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||1.654|-0.157|0.1050
73873658|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
73873659|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873660|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73954270|NCT00764868|147443218|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks||||||<0.001
73954271|NCT04438785|147443230|SUPERIORITY||Mean Difference (Final Values)|2.58|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Evaluate if the Apnea Hypopnea Index from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||<0.001
73954272|NCT04438785|147443231|SUPERIORITY||Median Difference (Final Values)|-0.971||||0.003|TWO_SIDED||||||t-test, 2 sided|||Evaluate if the O2 desaturation index (ODI) from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.003
73954273|NCT04438785|147443232|SUPERIORITY||Mean Difference (Net)|-0.364||||0.001|ONE_SIDED||||||t-test, 2 sided|||Evaluate if the IOPI tongue score from baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
73954274|NCT04438785|147443233|SUPERIORITY||Median Difference (Final Values)|-1.131||||0.001|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the IOPI lip score from the baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
73873661|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
73873662|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
73981334|NCT03386344|147507759|SUPERIORITY||Difference in LS Means|0.32|STANDARD_ERROR_OF_MEAN|0.46||0.4804|TWO_SIDED|95.0|-0.577|1.226|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||1.226|-0.577|0.4804
73981335|NCT03386344|147507760|SUPERIORITY||Difference in LS Means|-1.91|STANDARD_ERROR_OF_MEAN|0.336|<|0.0001|TWO_SIDED|95.0|-2.568|-1.252|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline body weight as a covariate.||-1.252|-2.568|<0.0001
73981336|NCT03386344|147507760|SUPERIORITY||Difference in LS Means|-1.7|STANDARD_ERROR_OF_MEAN|0.335|<|0.0001|TWO_SIDED|95.0|-2.36|-1.046|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline body weight as a covariate.||-1.046|-2.360|<0.0001
73981337|NCT03386344|147507761|SUPERIORITY||Difference in LS Means|-18.891|STANDARD_ERROR_OF_MEAN|4.5766|<|0.0001|TWO_SIDED|95.0|-27.8605|-9.9205|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, baseline fasting plasma glucose as a covariate.||-9.9205|-27.8605|<0.0001
73981338|NCT03386344|147507761|SUPERIORITY||Difference in LS Means|-21.333|STANDARD_ERROR_OF_MEAN|4.5902|<|0.0001|TWO_SIDED|95.0|-30.3294|-12.336|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, baseline fasting plasma glucose as a covariate.||-12.3360|-30.3294|<0.0001
73981339|NCT03386344|147507762|SUPERIORITY||Difference in LS Means|-0.8|STANDARD_ERROR_OF_MEAN|1.48||0.5864|TWO_SIDED|95.0|-3.705|2.095|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline SBP as a covariate.||2.095|-3.705|0.5864
73873663|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
73873664|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.65|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.65
73873665|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
73873666|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
73873667|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
73873668|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873669|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873670|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
73873671|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73873672|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
73981340|NCT03386344|147507762|SUPERIORITY||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|1.478||0.4315|TWO_SIDED|95.0|-4.058|1.734|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline SBP as a covariate.||1.734|-4.058|0.4315
73981341|NCT03386344|147507763|SUPERIORITY||Percentage Difference|10.5||||0.0172|TWO_SIDED|95.0|1.78|19.23|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from randomization strata of HbA1c (≤8.5, \>8.5%) at screening and randomization strata of sex (male, female) using Cochran-Mantel-Haenszel weights.||19.23|1.78|0.0172
73981342|NCT03386344|147507763|SUPERIORITY||Percentage Difference|12.0||||0.0076|TWO_SIDED|95.0|3.23|20.86|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from randomization strata of HbA1c (≤8.5, \>8.5%) at screening and randomization strata of sex (male, female) using Cochran-Mantel-Haenszel weights.||20.86|3.23|0.0076
74033475|NCT01533935|147619732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.001|TWO_SIDED|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||-0.001|-0.004|0.0010
73954275|NCT04438785|147443234|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.92|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the neck circumference from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.92
73954276|NCT04438785|147443235|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.92|ONE_SIDED||||||t-test, 2 sided|||Evaluate if the waist circumference from baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.92
73954277|NCT04438785|147443236|SUPERIORITY||Mean Difference (Final Values)|0.97||||0.98|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the BMI from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.98
73954278|NCT04438785|147443237|SUPERIORITY||Median Difference (Final Values)|-1.23||||0.001|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the Epworth Sleepiness Scale from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
73954279|NCT04438785|147443238|SUPERIORITY||Mean Difference (Net)|0.98||||0.22|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Evaluate if the Pittsburgh sleep quality index from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.22
73954280|NCT04011033|147443239|OTHER||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.16|0.63|||Log Rank|||||0.63|0.16|<0.001
73981343|NCT01180400|147507784|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.91||0.944|TWO_SIDED|95.0|-1.86|1.73||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.73|-1.86|0.944
73981344|NCT01180400|147507785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.26||0.974|TWO_SIDED|95.0|0.61|1.66|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.66|0.61|0.974
73981345|NCT01180400|147507786|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45|STANDARD_ERROR_OF_MEAN|0.41||0.184|TWO_SIDED|95.0|0.84|2.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.53|0.84|0.184
74033476|NCT01533935|147619732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.1206|TWO_SIDED|95.0|-0.002|0.0|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.000|-0.002|0.1206
73954281|NCT04011033|147443241|OTHER||||||=|0.003|||||||Fisher Exact|||||||=0.003
73981346|NCT01180400|147507787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.71||0.461|TWO_SIDED|95.0|0.55|3.78|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||3.78|0.55|0.461
73981347|NCT01180400|147507788|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87|STANDARD_ERROR_OF_MEAN|0.31||0.689|TWO_SIDED|95.0|0.43|1.75|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.75|0.43|0.689
74033477|NCT01533935|147619733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.294|0.364|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.364|0.294|<0.0001
74033478|NCT01533935|147619733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.099|0.169|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.169|0.099|<0.0001
74033479|NCT01533935|147619733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.1|0.17|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.170|0.100|<0.0001
73873673|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73954282|NCT04011033|147443242|OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
73954283|NCT04011033|147443244|OTHER||Hazard Ratio (HR)|0.37|||=|0.001|TWO_SIDED|95.0|0.19|0.71|||Log Rank|||||0.71|0.19|=0.001
73954284|NCT01823341|147443245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73954285|NCT01823341|147443246|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
73954286|NCT01823341|147443246|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
73954287|NCT01823341|147443247|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73954288|NCT01823341|147443247|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||||||0.005
73954289|NCT01823341|147443248|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73954290|NCT01823341|147443248|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
73954291|NCT01823341|147443249|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
73954292|NCT01823341|147443249|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
73954293|NCT01823341|147443250|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
73954294|NCT01823341|147443250|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||||||0.77
73954295|NCT01823341|147443251|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73954296|NCT01823341|147443251|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
73954297|NCT01823341|147443252|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
73954298|NCT01823341|147443252|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
73954299|NCT01823341|147443253|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
73954300|NCT01823341|147443253|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||t-test, 2 sided|||||||0.39
73954301|NCT01823341|147443254|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||0.53
73954302|NCT01823341|147443254|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||t-test, 2 sided|||||||0.28
73954303|NCT00689104|147443257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41||||0.003|TWO_SIDED|95.0|-0.72|-0.09||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.09|-0.72|0.003
73954304|NCT00689104|147443257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29||||0.01|TWO_SIDED|95.0|-0.61|0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||0.03|-0.61|0.010
73954305|NCT00689104|147443257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.11|TWO_SIDED|95.0|-0.42|0.21||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||0.21|-0.42|0.11
73954306|NCT00689104|147443258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.29||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.29|-0.90|<0.001
73954307|NCT00689104|147443258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44||||0.005|TWO_SIDED|95.0|-0.74|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.74|0.005
73954308|NCT00689104|147443258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25||||0.11|TWO_SIDED|95.0|-0.55|0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||0.06|-0.55|0.11
73954309|NCT00689104|147443259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.9|||<|0.001|TWO_SIDED|95.0|6.3|17.4||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.4|6.3|<0.001
73981348|NCT01180400|147507789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.44||0.831|TWO_SIDED|95.0|0.35|2.32|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.32|0.35|0.831
73981349|NCT01180400|147507790|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.72||0.525|TWO_SIDED|95.0|-0.96|1.89|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.89|-0.96|0.525
73981350|NCT01180400|147507791|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.964||95.0|-0.28|0.26|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.26|-0.28|0.964
74033480|NCT01533935|147619733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.305|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.269|0.34|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.340|0.269|<0.0001
74033481|NCT01533935|147619733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.075|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.145|0.075|<0.0001
73873674|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73873675|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
73873676|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
73954310|NCT00689104|147443259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|13.2|||<|0.001|TWO_SIDED|95.0|7.7|18.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||18.7|7.7|<0.001
73954311|NCT00689104|147443259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.6|||<|0.001|TWO_SIDED|95.0|7.1|18.2||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||18.2|7.1|<0.001
73954312|NCT00689104|147443260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39||||0.002|TWO_SIDED|95.0|-0.71|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.06|-0.71|0.002
73954313|NCT00689104|147443260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38||||0.002|TWO_SIDED|95.0|-0.71|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.05|-0.71|0.002
73954314|NCT00689104|147443260|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.35||||0.019|TWO_SIDED|95.0|-0.68|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||-0.03|-0.68|0.019
73954315|NCT00689104|147443261|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.4||||0.004|TWO_SIDED|95.0|-0.66|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.66|0.004
73981351|NCT01180400|147507792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.25||0.783|TWO_SIDED|95.0|0.54|1.58|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.58|0.54|0.783
73981352|NCT01180400|147507793|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.832|TWO_SIDED|95.0|-0.89|1.11||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-0.89|0.832
73873677|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
73873678|NCT01128426|147289450|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873679|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873680|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73954316|NCT00689104|147443261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.79|-0.26||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.26|-0.79|<0.001
73954317|NCT00689104|147443261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33||||0.016|TWO_SIDED|95.0|-0.6|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||-0.06|-0.60|0.016
73954318|NCT04873817|147443288|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||< 0.0001
73954319|NCT00924560|147443290|NON_INFERIORITY_OR_EQUIVALENCE|91-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.|LS Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.67|0.2|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.20|-0.67|
73954320|NCT00924560|147443290|NON_INFERIORITY_OR_EQUIVALENCE|28-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.|LS Mean Difference|-1.05|||||TWO_SIDED|95.0|-1.49|-0.61|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.61|-1.49|
73981353|NCT01180400|147507794|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.67||0.468|TWO_SIDED|95.0|-0.84|1.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.82|-0.84|0.468
73981354|NCT01180400|147507795|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.77||0.187|TWO_SIDED|95.0|-0.49|2.52|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.52|-0.49|0.187
73981355|NCT01180400|147507796|SUPERIORITY_OR_OTHER||LS mean|1.3|STANDARD_ERROR_OF_MEAN|0.86||0.145|TWO_SIDED|95.0|-0.44|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||2.95|-0.44|0.145
73981356|NCT01180400|147507797|SUPERIORITY_OR_OTHER||LS mean|-0.04|STANDARD_ERROR_OF_MEAN|0.766||0.956|TWO_SIDED|95.0|-1.549|1.466||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.466|-1.549|0.956
74033482|NCT01533935|147619733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.076|0.146|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.146|0.076|<0.0001
74033483|NCT00850759|147619750|SUPERIORITY_OR_OTHER||Slope|0.04|||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
73954321|NCT00924560|147443291|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|-0.00|
73954322|NCT00924560|147443291|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
73954323|NCT00924560|147443291|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
73954324|NCT00924560|147443291|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.02|-0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.01|-0.02|
73954325|NCT00924560|147443292|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|||||TWO_SIDED|95.0|-0.08|0.42||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.42|-0.08|
73954326|NCT00924560|147443292|SUPERIORITY_OR_OTHER||LS mean Difference|-0.43|||||TWO_SIDED|95.0|-0.68|-0.18||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.18|-0.68|
73954327|NCT00924560|147443292|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.39|0.24||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.24|-0.39|
73954328|NCT00924560|147443292|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74|||||TWO_SIDED|95.0|-1.05|-0.42||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.42|-1.05|
73954329|NCT00924560|147443293|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|0.00|
73873681|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873682|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
73873683|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
73873684|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73873685|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
73873686|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.20
73873687|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
73873688|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
73873689|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
73873690|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73873691|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873692|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73873693|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
73873694|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.56|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.56
73873695|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
73873696|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
73873697|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
73873698|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
73873699|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873700|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
73873701|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
73873702|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
73873703|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873704|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873705|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
73873706|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
73873707|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
73981357|NCT01180400|147507798|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.201|TWO_SIDED|95.0|-0.98|0.21||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.21|-0.98|0.201
73981358|NCT01180400|147507799|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.756|TWO_SIDED|95.0|-0.62|0.45|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.45|-0.62|0.756
73954330|NCT00924560|147443293|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
73954331|NCT00924560|147443293|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|0.00|
73954332|NCT00924560|147443293|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|0.95|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
73954333|NCT00924560|147443294|SUPERIORITY_OR_OTHER||LS mean Difference|0.13|||||TWO_SIDED|95.0|-0.03|0.28||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.28|-0.03|
73954334|NCT00924560|147443294|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.2|0.11||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.11|-0.20|
73954335|NCT00924560|147443294|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16|||||TWO_SIDED|95.0|-0.01|0.34||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.34|-0.01|
73981359|NCT01180400|147507800|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.62|TWO_SIDED|95.0|-0.4|0.68|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.68|-0.40|0.620
73981360|NCT01180400|147507801|SUPERIORITY_OR_OTHER||LS mean|0.15|STANDARD_ERROR_OF_MEAN|1.592||0.924|TWO_SIDED|95.0|-2.981|3.286|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||3.286|-2.981|0.924
73981361|NCT01180400|147507802|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.345|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.10|-0.30|0.345
74033484|NCT00300469|147619786|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
73873708|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73954336|NCT00924560|147443294|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.32|0.03||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.03|-0.32|
73954337|NCT00924560|147443295|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
73954338|NCT00924560|147443295|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
73954339|NCT00924560|147443295|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
73954340|NCT00924560|147443295|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
73954341|NCT00924560|147443296|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.48|||||TWO_SIDED|95.0|-23.57|12.61||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||12.61|-23.57|
73954342|NCT00924560|147443296|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.55|||||TWO_SIDED|95.0|-25.65|10.55||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||10.55|-25.65|
73954343|NCT00924560|147443296|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.09|||||TWO_SIDED|95.0|-34.99|10.81||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||10.81|-34.99|
73954344|NCT00924560|147443296|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.17|||||TWO_SIDED|95.0|-44.08|1.74||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||1.74|-44.08|
73954345|NCT02909101|147443345|SUPERIORITY|||||||0.039|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.039
73954346|NCT02909101|147443346|SUPERIORITY|||||||0.054|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.054
73954347|NCT02909101|147443347|OTHER|||||||0.744|||||||t-test, 2 sided|||To determine acceptability, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.||||0.744
73954348|NCT02909101|147443348|OTHER|||||||0.719|||||||t-test, 2 sided|||To determine acceptability in terms of helpfulness, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.||||0.719
73873709|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73954349|NCT02909101|147443349|SUPERIORITY|||||||0.337|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.337
73954350|NCT02909101|147443350|SUPERIORITY|||||||0.025|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.025
73954351|NCT02909101|147443351|SUPERIORITY|||||||0.133|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.133
73981362|NCT01180400|147507803|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.942|TWO_SIDED|95.0|-0.2|0.19|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.19|-0.20|0.942
73981363|NCT01180400|147507804|SUPERIORITY_OR_OTHER||LS mean|-0.011|STANDARD_ERROR_OF_MEAN|0.0198||0.576|TWO_SIDED|95.0|-0.05|0.0279||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0279|-0.0500|0.576
73981364|NCT01180400|147507804|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|2.11||0.842|TWO_SIDED|95.0|-4.58|3.73||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||3.73|-4.58|0.842
73981365|NCT03031782|147507820|SUPERIORITY||Cox Proportional Hazard|0.28|||<|0.001|TWO_SIDED|95.0|0.13|0.63|||Log Rank|Hazard ratios and associated 95% confidence intervals are based on a Cox proportional hazards model with treatment and analysis factors||Survival analysis of time to flare - TP2 (FAS2)||0.63|0.13|<0.001
73981366|NCT00886834|147507837|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
73981367|NCT03122860|147507839|SUPERIORITY||Median Difference (Final Values)|-0.46||||0.179|TWO_SIDED|95.0|-1.13|0.21|||ANCOVA|||||0.21|-1.13|0.179
73981368|NCT03122860|147507839|SUPERIORITY||Median Difference (Final Values)|-0.7||||0.031|TWO_SIDED|95.0|-1.34|-0.06|||ANCOVA|||||-0.06|-1.34|0.031
73981369|NCT03122860|147507839|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.675|TWO_SIDED|95.0|-0.81|0.52|||ANCOVA|||||0.52|-0.81|0.675
74033485|NCT00300469|147619786|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
73981370|NCT03122860|147507839|SUPERIORITY||Mean Difference (Final Values)|-0.82||||0.022|TWO_SIDED|95.0|-1.51|-0.12|||ANCOVA|||||-0.12|-1.51|0.022
73981371|NCT03122860|147507839|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.78|TWO_SIDED|95.0|-0.79|0.59|||ANCOVA|||||0.59|-0.79|0.780
73981372|NCT03122860|147507840|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.612|TWO_SIDED|95.0|-8.32|4.91|||ANCOVA|||||4.91|-8.32|0.612
73873710|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
73873711|NCT01128426|147289451|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873712|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
73954352|NCT01290094|147443356|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
73954353|NCT01290094|147443357|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
73954354|NCT01290094|147443358|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.001
73954355|NCT01290094|147443359|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.056
73954356|NCT01290094|147443360|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 12: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test|||||||<0.0005
73954357|NCT01290094|147443360|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 24: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test|||||||<0.0005
73954358|NCT01290094|147443361|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 12: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
73954359|NCT01290094|147443361|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Month 24: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.027
73981373|NCT03122860|147507840|SUPERIORITY||Mean Difference (Final Values)|-4.01||||0.223|TWO_SIDED|95.0|-10.47|2.46|||ANCOVA|||||2.46|-10.47|0.223
73981374|NCT03122860|147507840|SUPERIORITY||Mean Difference (Final Values)|1.84||||0.59|TWO_SIDED|95.0|-4.89|8.57|||ANCOVA|||||8.57|-4.89|0.590
73981375|NCT03122860|147507840|SUPERIORITY||Mean Difference (Final Values)|-7.36||||0.031|TWO_SIDED|95.0|-14.03|-0.69|||ANCOVA|||||-0.69|-14.03|0.031
73981376|NCT03122860|147507840|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.403|TWO_SIDED|95.0|-9.7|3.92|||ANCOVA|||||3.92|-9.70|0.403
73954360|NCT03230006|147443364|SUPERIORITY||Partial eta squared|0.152||||0.002|TWO_SIDED|95.0|||||ANOVA||A two-way mixed ANOVA was conducted to investigate treatment group differences in change in mean number of drinks consumed from baseline to post-treatment, as indicated by the Time by Treatment Condition interaction effect.|||||0.002
73954361|NCT03230006|147443364|SUPERIORITY||Partial eta squared|0.342|||<|0.001|TWO_SIDED|95.0||||The threshold for significance is p \<.05.|ANOVA||This is the partial eta squared for the main effect of time.|||||<.001
73954362|NCT03230006|147443364|SUPERIORITY||Partial eta squared|0.018||||0.309|TWO_SIDED|95.0|||||ANOVA||This is the partial eta squared for the main effect of treatment condition.|||||.309
73954363|NCT03230006|147443364|OTHER||F|38.92|||<|0.001|TWO_SIDED|95.0||||The threshold for significance is p \<.05.|ANOVA|||After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.||||<.001
73954364|NCT03230006|147443364|OTHER||F|5.43||||0.03|TWO_SIDED|95.0|||||ANOVA|||After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.||||.030
73954365|NCT03230006|147443364|OTHER||F|1.15||||0.016|TWO_SIDED|95.0|||||ANOVA||This is the simple main effect of treatment condition on mean number of drinks consumed per week at baseline. For the UP, n=51; for the TC, n=24.|After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.||||.016
73954366|NCT03230006|147443364|OTHER||F|7.78||||0.007|TWO_SIDED|95.0|||||ANOVA||This is the simple main effect of treatment condition on mean number of drinks consumed per week at post-treatment. For the UP, n=38; for the TC, n=21.|After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.||||.007
73954367|NCT04949399|147443366|SUPERIORITY||Difference (%)|30.4|||<|0.0001|TWO_SIDED|95.0|23.5|37.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||37.2|23.5|<.0001
73954368|NCT04949399|147443367|SUPERIORITY||Difference (%)|39.8|||<|0.0001|TWO_SIDED|95.0|32.0|47.7||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||47.7|32.0|<0.0001
73954369|NCT04949399|147443368|SUPERIORITY||Difference (%)|41.6|||<|0.0001|TWO_SIDED|95.0|33.7|49.6||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||49.6|33.7|<0.0001
73981377|NCT03122860|147507841|SUPERIORITY||Mean Difference (Final Values)|-2.58||||0.432|TWO_SIDED|95.0|-9.04|3.88|||ANCOVA|||||3.88|-9.04|0.432
73954370|NCT04949399|147443371|SUPERIORITY||Difference (%)|54.8|||<|0.0001|TWO_SIDED|95.0|46.8|62.8||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||62.8|46.8|<.0001
73954371|NCT04949399|147443372|SUPERIORITY||Difference (%)|39.1|||<|0.0001|TWO_SIDED|95.0|30.5|47.8||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||47.8|30.5|<.0001
73954372|NCT04949399|147443373|SUPERIORITY||Difference (%)|44.6|||<|0.0001|TWO_SIDED|95.0|36.8|52.5||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||52.5|36.8|<.0001
73954373|NCT04949399|147443374|SUPERIORITY||Difference (SE)|-5.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-6.7|-4.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-4.7|-6.7|<.0001
73954374|NCT04949399|147443377|SUPERIORITY||Difference (%)|46.1|||<|0.0001|TWO_SIDED|96.0|38.1|54.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||54.2|38.1|<0.0001
73954375|NCT04949399|147443378|SUPERIORITY||Difference (%)|51.9|||<|0.0001|TWO_SIDED|95.0|43.3|60.5||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||60.5|43.3|<0.0001
73954376|NCT04949399|147443379|SUPERIORITY||Difference (%)|40.1|||<|0.0001|TWO_SIDED|95.0|31.3|49.0||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||49.0|31.3|<0.0001
73954377|NCT04949399|147443380|SUPERIORITY||Difference (%)|45.2|||<|0.0001|TWO_SIDED|95.0|37.1|53.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||53.2|37.1|<0.0001
73954378|NCT04949399|147443381|SUPERIORITY||Difference (SE)|-5.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-6.8|-4.6||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-4.6|-6.8|<0.0001
73954379|NCT04949399|147443382|SUPERIORITY||Difference (SE)|-5.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-6.7|-4.5||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 30||-4.5|-6.7|<0.0001
73954380|NCT04949399|147443382|SUPERIORITY||Difference (SE)|-5.0|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-6.0|-3.9||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 60||-3.9|-6.0|<0.0001
73981378|NCT03122860|147507841|SUPERIORITY||Mean Difference (Final Values)|-4.34||||0.18|TWO_SIDED|95.0|-10.69|2.02|||ANCOVA|||||2.02|-10.69|0.180
73981379|NCT03122860|147507841|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.718|TWO_SIDED|95.0|-5.33|7.72|||ANCOVA|||||7.72|-5.33|0.718
73981380|NCT03122860|147507841|SUPERIORITY||Mean Difference (Final Values)|-7.99||||0.017|TWO_SIDED|95.0|-14.54|-1.45|||ANCOVA|||||-1.45|-14.54|0.017
73981381|NCT03122860|147507841|SUPERIORITY||Mean Difference (Final Values)|-1.39||||0.682|TWO_SIDED|95.0|-8.06|5.29|||ANCOVA|||||5.29|-8.06|0.682
73981382|NCT03122860|147507842|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.822|TWO_SIDED|95.0|-0.16|0.21|||ANCOVA|||||0.21|-0.16|0.822
73981383|NCT03122860|147507842|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.162|TWO_SIDED|95.0|-0.27|0.04|||ANCOVA|||||0.04|-0.27|0.162
73981384|NCT03122860|147507842|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.267|TWO_SIDED|95.0|-0.34|0.09|||ANCOVA|||||0.09|-0.34|0.267
73873713|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
73954381|NCT04949399|147443382|SUPERIORITY||Difference (SE)|-3.9|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.9|-2.8||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 90||-2.8|-4.9|<0.0001
73954382|NCT00961805|147443403|SUPERIORITY_OR_OTHER||||||<|0.001||||||Differences in the behavior of the groups over time.|ANOVA|||"Sample size was calculated by visual analogue scale for pain (alpha error of 5%, beta error of 20% and standard deviation of 2). The sample was determined to contain 30 patients in each group. Ten additional patients were added to compensate possible losses.~Analysis was intention to treat using the LOCF technique."||||<0.001
73954383|NCT00961805|147443404|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.001
73954384|NCT00961805|147443405|SUPERIORITY_OR_OTHER||||||<|0.003||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.003
73954385|NCT00961805|147443406|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.146
73954386|NCT00961805|147443407|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.131
73954387|NCT00961805|147443408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.001
73954388|NCT00961805|147443409|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.580
73981385|NCT03122860|147507842|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.685|TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|0.685
73954389|NCT00961805|147443410|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.082
73954390|NCT00961805|147443411|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.055
73954391|NCT00961805|147443412|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.003
73954392|NCT00961805|147443413|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.021
73873714|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method]|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
73873715|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
73873716|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73954393|NCT00961805|147443414|SUPERIORITY_OR_OTHER|||||||0.136||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.136
73954394|NCT00961805|147443415|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.009
73954395|NCT02949271|147443416|OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
73954396|NCT02949271|147443417|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
73954397|NCT02949271|147443419|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
73954398|NCT02949271|147443420|OTHER|||||||0.28|||||||Chi-squared|||||||0.28
73954399|NCT02949271|147443421|OTHER|||||||0.85|||||||Chi-squared|||||||0.85
73954400|NCT02949271|147443422|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
73954401|NCT02949271|147443423|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73954402|NCT02949271|147443424|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
73954403|NCT02949271|147443426|OTHER|||||||0.08|||||||Chi-squared|||||||0.08
73954404|NCT05458102|147443427|OTHER||Geometric Least-squares Mean Ratio|560.0|||||TWO_SIDED|90.0|414.0|757.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||757|414|
73954405|NCT05458102|147443427|OTHER||Geometric Least-squares Mean Ratio|137.0|||||TWO_SIDED|90.0|99.5|189.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||189|99.5|
73954406|NCT05458102|147443428|OTHER||Geometric Least-squares Mean Ratio|433.0|||||TWO_SIDED|90.0|347.0|540.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||540|347|
73954407|NCT05458102|147443428|OTHER||Geometric Least-squares Mean Ratio|118.0|||||TWO_SIDED|90.0|93.5|150.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||150|93.5|
73954408|NCT05458102|147443429|OTHER||Geometric Least-squares Mean Ratio|752.0|||||TWO_SIDED|90.0|525.0|1080.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||1080|525|
73954409|NCT05458102|147443429|OTHER||Geometric Least-squares Mean Ratio|118.0|||||TWO_SIDED|90.0|80.3|172.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||172|80.3|
73954410|NCT05458102|147443431|OTHER||Geometric Least-squares Mean Ratio|68.5|||||TWO_SIDED|90.0|45.5|103.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||103|45.5|
73954411|NCT05458102|147443431|OTHER||Geometric Least-squares Mean Ratio|65.4|||||TWO_SIDED|90.0|42.5|101.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||101|42.5|
73954412|NCT05458102|147443435|OTHER||Geometric Least-squares Mean Ratio|120.0|||||TWO_SIDED|90.0|104.0|138.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||138|104|
73981386|NCT03122860|147507842|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.342|TWO_SIDED|95.0|-0.09|0.24|||ANCOVA|||||0.24|-0.09|0.342
73981387|NCT03122860|147507843|SUPERIORITY||Mean Difference (Final Values)|-2.13||||0.5|TWO_SIDED|95.0|-8.36|4.1|||ANCOVA|||||4.10|-8.36|0.500
73981388|NCT03122860|147507843|SUPERIORITY||Mean Difference (Final Values)|-5.54||||0.082|TWO_SIDED|95.0|-11.8|0.72|||ANCOVA|||||0.72|-11.80|0.082
73981389|NCT03122860|147507843|SUPERIORITY||Mean Difference (Final Values)|-1.94||||0.552|TWO_SIDED|95.0|-8.36|4.48|||ANCOVA|||||4.48|-8.36|0.552
73954413|NCT05458102|147443435|OTHER||Geometric Least-squares Mean Ratio|111.0|||||TWO_SIDED|90.0|95.4|128.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||128|95.4|
73954414|NCT01323660|147443476|SUPERIORITY_OR_OTHER||Least squares mean difference|25.0||||0.456|TWO_SIDED|95.0|-41.0|91.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||91.0|-41.0|0.456
73954415|NCT01323660|147443476|SUPERIORITY_OR_OTHER||Least squares mean difference|74.7||||0.033|TWO_SIDED|95.0|6.0|143.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||143.4|6.0|0.033
73954416|NCT01323660|147443476|SUPERIORITY_OR_OTHER||Least squares mean difference|30.6||||0.295|TWO_SIDED|95.0|-26.8|88.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||88.0|-26.8|0.295
73954417|NCT01323660|147443476|SUPERIORITY_OR_OTHER||Least squares mean difference|44.4||||0.188|TWO_SIDED|95.0|-21.8|110.6||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||110.6|-21.8|0.188
73954418|NCT01323660|147443476|SUPERIORITY_OR_OTHER||Least squares mean difference|38.8||||0.187|TWO_SIDED|95.0|-18.9|96.5||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||96.5|-18.9|0.187
73954419|NCT01323660|147443476|SUPERIORITY_OR_OTHER||Least squares mean difference|-8.9||||0.801|TWO_SIDED|95.0|-77.8|60.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg|||60.1|-77.8|0.801
73954420|NCT01323660|147443476|SUPERIORITY_OR_OTHER||Least squares mean difference|35.2||||0.233|TWO_SIDED|95.0|-22.7|93.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||93.1|-22.7|0.233
73954421|NCT01323660|147443476|SUPERIORITY_OR_OTHER||Least squares mean difference|69.4||||0.003|TWO_SIDED|95.0|24.5|114.4|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||114.4|24.5|0.003
73954422|NCT01323660|147443476|SUPERIORITY_OR_OTHER||Least squares mean difference|65.8||||0.005|TWO_SIDED|95.0|20.3|111.3|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||111.3|20.3|0.005
73981390|NCT03122860|147507843|SUPERIORITY||Mean Difference (Final Values)|-6.86||||0.033|TWO_SIDED|95.0|-13.16|-0.56|||ANCOVA|||||-0.56|-13.16|0.033
73981391|NCT03122860|147507843|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.887|TWO_SIDED|95.0|-5.79|6.68|||ANCOVA|||||6.68|-5.79|0.887
73954423|NCT01323660|147443477|SUPERIORITY_OR_OTHER||Least squares mean difference|0.144|||<|0.001|TWO_SIDED|95.0|0.086|0.203|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||0.203|0.086|<0.001
73954424|NCT01323660|147443477|SUPERIORITY_OR_OTHER||Least squares mean difference|0.255|||<|0.001|TWO_SIDED|95.0|0.193|0.318|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||0.318|0.193|<0.001
73954425|NCT01323660|147443477|SUPERIORITY_OR_OTHER||Least squares mean difference|0.112|||<|0.001||95.0|0.061|0.163|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||0.163|0.061|<0.001
73954426|NCT01323660|147443477|SUPERIORITY_OR_OTHER||Least squares mean difference|0.099|||<|0.001|TWO_SIDED|95.0|0.041|0.157|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||0.157|0.041|<0.001
73954427|NCT01323660|147443477|SUPERIORITY_OR_OTHER||Least squares mean difference|0.132|||<|0.001|TWO_SIDED|95.0|0.081|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.183|0.081|<0.001
73954428|NCT01323660|147443477|SUPERIORITY_OR_OTHER||Least squares mean difference|0.006||||0.849|TWO_SIDED|95.0|-0.055|0.067|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.067|-0.055|0.849
73954429|NCT01323660|147443477|SUPERIORITY_OR_OTHER||Least squares mean difference|0.15|||<|0.001|TWO_SIDED|95.0|0.098|0.201|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.201|0.098|<0.001
73954430|NCT01323660|147443477|SUPERIORITY_OR_OTHER||Least squares mean difference|0.243|||<|0.001|TWO_SIDED|95.0|0.202|0.284|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.284|0.202|<0.001
73954431|NCT01323660|147443477|SUPERIORITY_OR_OTHER||Least squares mean difference|0.261|||<|0.001|TWO_SIDED|95.0|0.22|0.303|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||0.303|0.220|<0.001
73981392|NCT03122860|147507844|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.473|TWO_SIDED|95.0|-7.99|3.72|||ANCOVA|||||3.72|-7.99|0.473
73981393|NCT03122860|147507844|SUPERIORITY||Mean Difference (Final Values)|-6.31||||0.04|TWO_SIDED|95.0|-12.33|-0.29|||ANCOVA|||||-0.29|-12.33|0.040
73981394|NCT03122860|147507844|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.577|TWO_SIDED|95.0|-4.35|7.79|||ANCOVA|||||7.79|-4.35|0.577
73981395|NCT03122860|147507844|SUPERIORITY||Mean Difference (Final Values)|-8.95||||0.003|TWO_SIDED|95.0|-14.9|-3.01|||ANCOVA|||||-3.01|-14.90|0.003
73981396|NCT03122860|147507844|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.947|TWO_SIDED|95.0|-6.37|5.96|||ANCOVA|||||5.96|-6.37|0.947
73954432|NCT00372567|147443516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.484|2.235|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||No hypothesis tested.||2.235|0.484|
73954433|NCT00372567|147443517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.818|||||TWO_SIDED|95.0|0.64|12.41|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||12.41|0.640|
73954434|NCT00372567|147443519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.027|||||TWO_SIDED|95.0|0.505|2.088|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||2.088|0.505|
73981397|NCT03122860|147507845|SUPERIORITY||Mean Difference (Final Values)|-3.05||||0.299|TWO_SIDED|95.0|-8.83|2.73|||ANCOVA|||||2.73|-8.83|0.299
73954435|NCT00372567|147443520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.308|||||TWO_SIDED|95.0|0.4|13.0|||Cochran-Mantel-Haenszel|Stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||13.0|0.4|
73954436|NCT00372567|147443523|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.434|||||TWO_SIDED|95.0|1.057|11.15|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||11.15|1.057|
73954437|NCT00372567|147443524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.379|||||TWO_SIDED|95.0|0.1|2.3|||Cochran-Mantel-Haenszel|Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||2.3|0.1|
73954438|NCT00372567|147443525|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.318|||||TWO_SIDED|95.0|0.5|3.8|||Cochran-Mantel-Haenszel|Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||3.8|0.5|
73981398|NCT03122860|147507845|SUPERIORITY||Mean Difference (Final Values)|-7.18||||0.021|TWO_SIDED|95.0|-13.24|-1.12|||ANCOVA|||||-1.12|-13.24|0.021
73981399|NCT03122860|147507845|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.675|TWO_SIDED|95.0|-4.75|7.33|||ANCOVA|||||7.33|-4.75|0.675
73981400|NCT03122860|147507845|SUPERIORITY||Mean Difference (Final Values)|-8.63||||0.006|TWO_SIDED|95.0|-14.7|-2.55|||ANCOVA|||||-2.55|-14.70|0.006
73981401|NCT03122860|147507845|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.925|TWO_SIDED|95.0|-5.99|6.59|||ANCOVA|||||6.59|-5.99|0.925
73981402|NCT03122860|147507846|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.062|TWO_SIDED|95.0|-1.18|0.03|||ANCOVA|||||0.03|-1.18|0.062
74033486|NCT00300469|147619787|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||0.005
73954439|NCT03566680|147443554|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73954440|NCT03566680|147443555|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73954441|NCT03566680|147443556|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73954442|NCT03566680|147443557|EQUIVALENCE|||||||0.73|||||||t-test, 2 sided|||||||0.73
73954443|NCT03566680|147443558|EQUIVALENCE|||||||0.08|||||||t-test, 2 sided|||||||0.08
73954444|NCT03566680|147443559|EQUIVALENCE|||||||0.72|||||||t-test, 2 sided|||||||0.72
73954445|NCT02374957|147443571|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over initial six weeks (two-sided test)."||||0.26
73954446|NCT02374957|147443572|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over three months (two-sided test)."||||0.17
73954447|NCT02374957|147443573|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over initial six weeks (two-sided test)."||||0.027
73954448|NCT02374957|147443574|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over three months (two-sided test)."||||0.014
73981403|NCT03122860|147507846|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.001|TWO_SIDED|95.0|-1.54|-0.37|||ANCOVA|||||-0.37|-1.54|0.001
73981404|NCT03122860|147507846|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.693|TWO_SIDED|95.0|-0.75|0.5|||ANCOVA|||||0.50|-0.75|0.693
73981405|NCT03122860|147507846|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.012|TWO_SIDED|95.0|-1.39|-0.17|||ANCOVA|||||-0.17|-1.39|0.012
73981406|NCT03122860|147507846|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.697|TWO_SIDED|95.0|-0.49|0.74|||ANCOVA|||||0.74|-0.49|0.697
73981407|NCT03122860|147507847|SUPERIORITY||Mean Difference (Final Values)|-3.32||||0.254|TWO_SIDED|95.0|-9.04|2.4|||ANCOVA|||||2.40|-9.04|0.254
73981408|NCT03122860|147507847|SUPERIORITY||Mean Difference (Final Values)|-6.86||||0.031|TWO_SIDED|95.0|-13.1|-0.63|||ANCOVA|||||-0.63|-13.10|0.031
73981409|NCT03122860|147507847|SUPERIORITY||Mean Difference (Final Values)|-1.46||||0.616|TWO_SIDED|95.0|-7.2|4.28|||ANCOVA|||||4.28|-7.20|0.616
73981410|NCT03122860|147507847|SUPERIORITY||Mean Difference (Final Values)|-7.62||||0.01|TWO_SIDED|95.0|-13.41|-1.82|||ANCOVA|||||-1.82|-13.41|0.010
73981411|NCT03122860|147507847|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.961|TWO_SIDED|95.0|-5.74|5.46|||ANCOVA|||||5.46|-5.74|0.961
73981412|NCT01138657|147507848|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.36|0.7|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.||0.70|0.36|<0.001
73873717|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
74089598|NCT02791893|147731970|SUPERIORITY|||||||0.47||||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention pain severity was regressed on pre-intervention pain severity and condition, using an ANCOVA model.||||0.47
73873718|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
73873719|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73873720|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873721|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
73981413|NCT01138657|147507848|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56|||<|0.001|TWO_SIDED|95.0|0.4|0.76|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.||0.76|0.40|< 0.001
73981414|NCT01138657|147507849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.29||||0.011|TWO_SIDED|95.0|-0.51|-0.07|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.07|-0.51|0.011
73981415|NCT01138657|147507849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.25||||0.019|TWO_SIDED|95.0|-0.46|-0.04|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations (from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.04|-0.46|0.019
73981416|NCT01138657|147507850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.43|-0.11|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.11|-0.43|<0.001
73981417|NCT01138657|147507850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.43|-0.12|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.12|-0.43|<0.001
73981418|NCT01138657|147507851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.07||||0.003|TWO_SIDED|95.0|-0.11|-0.02|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.02|-0.11|0.003
73981419|NCT01138657|147507851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.06||||0.008|TWO_SIDED|95.0|-0.1|-0.02|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.02|-0.10|0.008
73981420|NCT01138657|147507852|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.231|TWO_SIDED|95.0|0.39|1.26|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.26|0.39|0.231
73981421|NCT01138657|147507852|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68||||0.191|TWO_SIDED|95.0|0.38|1.21|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.21|0.38|0.191
73873722|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873723|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
73873724|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73873725|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
73954449|NCT02374957|147443575|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over initial six weeks (two-sided test)."||||0.82
73954450|NCT02374957|147443576|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over three months (two-sided test)."||||0.61
73954451|NCT02374957|147443577|SUPERIORITY|||||||0.26|||||||Log Rank|||"Null hypothesis: time to patency-failure (graft occlusion) is the same between treatment arms.~Alternate hypothesis: one arm differs from the other in durability of graft patency (two-sided test)."||||0.26
73954452|NCT05349084|147443589|EQUIVALENCE|A Fisher's exact test was performed to determine the association between coronary artery stenosis and PET myocardial blood flow (MBF) values during stress. The following myocardial segments were analyzed: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). Coronary arteries were categorized as coronary arteries with a diameter stenosis ≥50% or \<50%. The MBF values during stress were categorized as normal or abnormal. Normal MBF is defined as \>1.8 mL/g/min.||||||0.2522||||||The threshold for statistical significance was p = 0.05.|Fisher Exact|||||||0.2522
73954453|NCT05349084|147443590|OTHER|A Pearson's Correlation test was performed between PET MFR during stress and CT-FFR by territory.||||||0.028||||||The threshold for statistical significance was p = 0.05.|Pearson's correlation test|A Pearson's Correlation test was performed between PET MFR during stress and CT-FFR by territory.||||||0.028
73954454|NCT00958009|147443617|SUPERIORITY_OR_OTHER||mean positive response|0.86|||||TWO_SIDED|95.0|0.8|0.93|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower bound of the 95% confidence interval is \>0.50.|||0.93|0.80|
73954455|NCT00558753|147443619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.003||95.0|||||t-test, 2 sided|||||||0.003
73954456|NCT00558753|147443620|SUPERIORITY_OR_OTHER||Independence: Chi-squared|10.3||||0.0013||95.0|||||Chi-squared|||For 3 month followup on incidence of neuropathic pain.||||0.0013
73954457|NCT00558753|147443620|SUPERIORITY_OR_OTHER||Independence: Chi-squared|6.05||||0.0139|||||||Chi-squared|||For 6 month followup on incidence of neuropathic pain.||||0.0139
73981422|NCT01138657|147507853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-11.4||||0.02|TWO_SIDED|95.0|-20.9|-1.8|||ANOVA|ANOVA with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-1.8|-20.9|0.020
73981423|NCT01138657|147507853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-5.1||||0.428|TWO_SIDED|95.0|-17.7|7.5|||Chi-squared, Corrected|ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||7.5|-17.7|0.428
73981424|NCT01138657|147507854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|4.2||||0.01|TWO_SIDED|95.0|1.02|7.38|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||7.38|1.02|0.010
73981425|NCT01138657|147507854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|3.67||||0.019|TWO_SIDED|95.0|0.62|6.71|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.71|0.62|0.019
73981426|NCT01138657|147507855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.86||||0.346|TWO_SIDED|95.0|-2.03|5.75|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.75|-2.03|0.346
73981427|NCT01138657|147507855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.31||||0.496|TWO_SIDED|95.0|-2.47|5.09|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.09|-2.47|0.496
73873726|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73954458|NCT00558753|147443621|SUPERIORITY_OR_OTHER||Slope|-4.2||||0.0133||95.0||||Test of condition(Placebo v Pregabalin) main effect.|Mixed Models Analysis|Mixed model with main effects and time by condition interaction.||Mixed model test of condition (Placebo v Pregabalin) main effect.||||0.0133
73954459|NCT00558753|147443621|SUPERIORITY_OR_OTHER||Interaction Slice F-value|1.04||||0.3097||95.0|||||Mixed Models Analysis|Mixed model test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)||Test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)||||0.3097
73954460|NCT00558753|147443621|SUPERIORITY_OR_OTHER||Interaction Slice F-value|5.1||||0.0247||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 2-day post surgery time point (Slice)||||0.0247
73954461|NCT00558753|147443621|SUPERIORITY_OR_OTHER||Interaction Slice F-value|3.11||||0.0786||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 3-day post surgery time point (Slice)||||0.0786
73954462|NCT00558753|147443621|SUPERIORITY_OR_OTHER||Interaction Slice F-value|5.04||||0.0254||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 30-day post surgery time point (Slice)||||0.0254
73954463|NCT01072929|147443629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.0097|TWO_SIDED|95.0|-6.58|-0.92||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||-0.92|-6.58|0.0097
74033487|NCT00300469|147619787|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||0.010
74033488|NCT00300469|147619788|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
74033489|NCT00300469|147619788|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
74033490|NCT00578864|147619806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367||95.0|||||Fisher Exact|||||||0.367
74033491|NCT00578864|147619809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0|||||Fisher Exact|||||||0.592
74089599|NCT02791893|147731970|SUPERIORITY|||||||0.58||||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase are not included limiting the sample to 10 subjects in each condition (N=20). Post-intervention pain severity was regressed on pre-intervention pain severity and condition, using an ANCOVA model.||||0.58
73954464|NCT01072929|147443629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0385|TWO_SIDED|95.0|-5.71|-0.16||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||-0.16|-5.71|0.0385
73954465|NCT04824131|147443653|OTHER||Exact CI for Proportions|0.0|||||TWO_SIDED|95.0|0.0|6.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedures|6.7|0|
74033492|NCT01253044|147619850|SUPERIORITY_OR_OTHER|||||||0.912|TWO_SIDED||||||MMRM|||||||.912
74033493|NCT01253044|147619851|SUPERIORITY_OR_OTHER|||||||0.273|TWO_SIDED||||||MMRM|||||||.273
74033494|NCT00436969|147619859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.472||||0.696|TWO_SIDED|95.0|-8.888|5.943||The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.||5.943|-8.888|0.696
74033495|NCT00436969|147619860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-15.6|15.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.||15.1|-15.6|
74033496|NCT00436969|147619861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|||||TWO_SIDED|95.0|-19.7|9.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.||9.1|-19.7|
74033497|NCT00436969|147619862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.87||||0.827|TWO_SIDED|95.0|-8.698|6.957||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.957|-8.698|0.827
74033498|NCT00436969|147619863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.875||||0.392|TWO_SIDED|95.0|-9.472|3.723||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.723|-9.472|0.392
74033499|NCT00436969|147619864|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.932||||0.772|TWO_SIDED|95.0|-7.26|5.396||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||5.396|-7.260|0.772
74033500|NCT00436969|147619865|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.028||||0.707|TWO_SIDED|95.0|-4.338|6.393||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.393|-4.338|0.707
73873727|NCT01128426|147289451|SUPERIORITY_OR_OTHER|||||||0.94|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.94
73873728|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.56|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.56
73873729|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
73954466|NCT04824131|147443654|OTHER||Exact CI for Proportions|61.5|||||TWO_SIDED|95.0|47.0|74.7|||||||Exact 95% confidence interval for proportion for Participants who received at least one injection and preferred injectable PrEP at end of step 2.|74.7|47.0|
73954467|NCT04824131|147443657|OTHER||Exact CI for Proportions|94.3|||||TWO_SIDED|95.0|84.3|98.8|||||||The Exact 95% Confidence Interval for Proportion for Number of Participants with Grade 2 or above AEs during Injection Phase|98.8|84.3|
73954468|NCT04824131|147443658|OTHER||Exact CI for Proportions|100.0|||||TWO_SIDED|95.0|93.3|100.0|||||||Exact 95% Confidence Interval for Proportion for Participants who received at least one Injection who Completed All Scheduled Injections|100|93.3|
73981428|NCT01138657|147507856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|5.12||||0.036|TWO_SIDED|95.0|0.34|9.9|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||9.90|0.34|0.036
73981429|NCT01138657|147507856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|4.14||||0.077|TWO_SIDED|95.0|-0.45|8.72|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||8.72|-0.45|0.077
73981430|NCT01138657|147507857|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|10.02|||<|0.001|TWO_SIDED|95.0|4.86|15.19|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||15.19|4.86|<0.001
73981431|NCT01138657|147507857|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|8.83|||<|0.001|TWO_SIDED|95.0|3.88|13.79|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%||13.79|3.88|<0.001
73981432|NCT03875729|147507858|SUPERIORITY||Mean Difference (Net)|0.1253|||<|0.001|TWO_SIDED|95.0|0.0852|0.1653||ITT: The ANCOVA model included treatment, age group at randomization, and baseline C-peptide ln(AUC+1) as independent variables. Missing data at Week 78 were multiply imputed using pattern-mixture model under the missing not at random assumption.|ANCOVA||Least squares mean (LSmean) difference = Teplizumab - Placebo|This study was designed to show a difference of at least a 40% in C-peptide response between teplizumab and placebo. In geometric means, this translates to a value of (1.4×0.28) = 0.392. Consequently, approximately 300 participants were planned for enrollment, assuming 2-sided α=0.05, 90% power, 2:1 randomization, and a 10% dropout rate.||0.1653|0.0852|<0.001
73981433|NCT03875729|147507858|SUPERIORITY||Mean Difference (Net)|0.1385|||<|0.001|TWO_SIDED|95.0|0.0994|0.1776||PP: The ANCOVA model included treatment, age group at randomization, and baseline C-peptide ln(AUC+1) as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||Least squares mean (LSmean) difference = teplizumab - placebo|||0.1776|0.0994|<0.001
73981434|NCT03875729|147507859|SUPERIORITY||Mean Difference (Final Values)|-0.131||||0.085|TWO_SIDED|95.0|-0.28|0.018||ITT: ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||0.018|-0.280|0.085
73981435|NCT03875729|147507859|SUPERIORITY||Mean Difference (Final Values)|-0.167|||<|0.001|TWO_SIDED|95.0|-0.256|-0.078||PP: ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||-0.078|-0.256|<0.001
73981436|NCT03875729|147507860|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.606|TWO_SIDED|95.0|-0.42|0.24||ITT: ANCOVA model included treatment, age group at randomization, screening peak C-peptide category, baseline HbA1c as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA|||||0.24|-0.42|0.606
73981437|NCT03875729|147507860|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.454|TWO_SIDED|95.0|-0.46|0.2||PP: ANOVA model included treatment, age group at randomization, screening peak C-peptide category, baseline HbA1c as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||0.20|-0.46|0.454
73873730|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73954469|NCT04824131|147443659|OTHER||Mean Difference (Final Values)|-0.2728|STANDARD_ERROR_OF_MEAN|0.1704||0.1093|TWO_SIDED|95.0|-0.61|0.06||"GEE for Change in Sexual Behavior - Number of Sexual Partners - Visit as Continuous Variable.~Difference from baselines in the number of sex partners (vaginal or anal sex) reported in the past month"|poisson model||"GEE for Change in Sexual Behavior - Number of Sexual Partners - Visit as Continuous Variable.~Difference from baselines in the number of sex partners (vaginal or anal sex) reported in the past month"|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model count outcomes (number of sexual partners) using a poisson model.||0.06|-0.61|0.1093
73873731|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
73873732|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73954470|NCT04824131|147443660|OTHER||Mean Difference (Final Values)|-0.5859|STANDARD_ERROR_OF_MEAN|0.2253||0.0093|TWO_SIDED|95.0|-1.03|-0.14||GEE for Change in Sexual Behavior - Number of Episodes of Vaginal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of vaginal sex without a condom reported in the past month|poisson model||GEE for Change in Sexual Behavior - Number of Episodes of Vaginal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of vaginal sex without a condom reported in the past month.|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model count outcomes (number of episodes of vaginal sex without a condom) using a poisson model.||-0.14|-1.03|0.0093
73954471|NCT04824131|147443660|OTHER||Mean Difference (Final Values)|-0.3087|STANDARD_ERROR_OF_MEAN|1.4036||0.8259|TWO_SIDED|95.0|-3.06|2.44||GEE for Change in Sexual Behavior - Number of Episodes of Anal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of anal sex without a condom reported in the past month|Regression, Logistic||GEE for Change in Sexual Behavior - Number of Episodes of Anal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of anal sex without a condom reported in the past month|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model binary outcomes (any episodes of anal sex without a condom) using a logistic model.||2.44|-3.06|0.8259
73954472|NCT04824131|147443661|OTHER||CI for Incidence rate, exact Poisson|0.0|||||TWO_SIDED|95.0|0.0|10.8|||||Person-years: 34.0||Incidence rate is calculated HIV infections per 100 person years. CI for Incidence rate is calculated using exact Poisson method|10.8|0.0|
73954473|NCT04640571|147443681|EQUIVALENCE|Simple one-way t-test to assess if pravastatin AUC value is larger after metformin than after placebo.||||||0.02|||||||t-test, 1 sided|||||||0.02
73954474|NCT04640571|147443682|EQUIVALENCE|Simple one-way t-test to assess if pravastatin Cmax value is larger after metformin than after placebo|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954475|NCT04640571|147443683|EQUIVALENCE|Simple one-way t-test to assess if CDCA AUC value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954476|NCT04640571|147443684|EQUIVALENCE|Simple one-way t-test to assess if CDCA Cmax value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954477|NCT04640571|147443685|EQUIVALENCE|Simple one-way t-test to assess if acyclovir AUC value is reduced after polysorbate 80 than after placebo|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954478|NCT04640571|147443686|EQUIVALENCE|Simple one-way t-test to assess if acyclovir Cmax value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73873733|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
73954479|NCT04640571|147443687|EQUIVALENCE|Simple one-way t-test to assess if CDCA AUC value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954480|NCT04640571|147443688|EQUIVALENCE|Simple one-way t-test to assess if CDCA Cmax value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954481|NCT04640571|147443689|EQUIVALENCE|Simple one-way t-test to assess if enalaprilat AUC value is increased after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954482|NCT04640571|147443690|EQUIVALENCE|Simple one-way t-test to assess if enalaprilat Cmax value is increased after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954483|NCT04640571|147443691|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid AUC value is larger after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954484|NCT04640571|147443692|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid Cmax value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73873734|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873735|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.32|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.32
73873736|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
73873737|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
73873738|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
73954485|NCT04640571|147443693|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid AUC value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954486|NCT04640571|147443694|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid Cmax value is larger after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954487|NCT02783950|147443714|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
73954488|NCT02783950|147443715|SUPERIORITY|||||||0.7|||||||Wilcoxon Rank Test p-value|||||||0.70
73954489|NCT04319094|147443740|SUPERIORITY||Mean Difference (Net)|-3.7|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.77|-2.62||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = Post-intervention - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-2.62|-4.77|<0.0001
73954490|NCT04319094|147443740|SUPERIORITY||Mean Difference (Net)|-2.53|STANDARD_ERROR_OF_MEAN|0.65||0.0001|TWO_SIDED|95.0|-3.81|-1.25||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 3-month - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.25|-3.81|0.0001
73954491|NCT04319094|147443740|SUPERIORITY||Median Difference (Net)|-2.83|STANDARD_ERROR_OF_MEAN|0.66|<|0.0001|TWO_SIDED|95.0|-4.13|-1.53||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 6-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.53|-4.13|<0.0001
73954492|NCT04319094|147443740|SUPERIORITY||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|0.65|<|0.0001|TWO_SIDED|95.0|-4.03|-1.49||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 9-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.49|-4.03|<0.0001
73981438|NCT03875729|147507861|SUPERIORITY||Mean Difference (Final Values)|4.71||||0.151|TWO_SIDED|95.0|-1.72|11.15||ITT: The ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||11.15|-1.72|0.151
73981439|NCT03875729|147507861|SUPERIORITY||Mean Difference (Final Values)|6.17||||0.045|TWO_SIDED|95.0|0.13|12.22||PP: The ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||12.22|0.13|0.045
73981440|NCT03875729|147507862|SUPERIORITY||Rate ratio|1.1||||0.634|TWO_SIDED|95.0|0.74|1.64||ITT: Estimates and p-values were obtained from a negative binomial regression model using rate of hypoglycemic episodes as dependent variable and treatment, age group at randomization, and screening peak C-peptide category as independent variables.|Negative binomial regression model||Rate ratio = teplizumab / placebo.|||1.64|0.74|0.634
73981441|NCT03875729|147507862|SUPERIORITY||Rate ratio|1.09||||0.69|TWO_SIDED|95.0|0.72|1.65||PP: Estimates and p-values were obtained from a negative binomial regression model using rate of hypoglycemic episodes as dependent variable and treatment age group at randomization, and screening peak C-peptide category as independent variables.|Rate ratio||Rate ratio = teplizumab / placebo.|||1.65|0.72|0.690
73873739|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
73873740|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
73873741|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
74033501|NCT00436969|147619866|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.82||||0.79|TWO_SIDED|95.0|-6.866|5.227||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||5.227|-6.866|0.790
74033502|NCT00436969|147619867|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.13||||0.685|TWO_SIDED|95.0|-4.341|6.001||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.001|-4.341|0.685
74033503|NCT00436969|147619868|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.317||||0.018|TWO_SIDED|95.0|1.249|13.386||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||13.386|1.249|0.018
74033504|NCT00436969|147619869|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.361||||0.369|TWO_SIDED|95.0|-2.801|7.522||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||7.522|-2.801|0.369
73954493|NCT04319094|147443740|SUPERIORITY||Mean Difference (Net)|-2.56|STANDARD_ERROR_OF_MEAN|0.71||0.0003|TWO_SIDED|95.0|-3.95|-1.17||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference =12-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.17|-3.95|0.0003
73873742|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
73954494|NCT04319094|147443740|SUPERIORITY|||||||0.4375|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of PHQ-9 over time between the control and PEERS participants.||||0.4375
73954495|NCT04319094|147443741|SUPERIORITY||Mean Difference (Net)|1.61|STANDARD_ERROR_OF_MEAN|2.42||0.51|TWO_SIDED|95.0|-3.15|6.37||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36 - Physical Functioning scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|6.37|-3.15|0.51
73981442|NCT00999336|147507873|OTHER|Geometric least squares means, ratios, and confidence intervals (CIs) were estimated from an analysis of covariance (ANCOVA) of natural log transformed values.|Ratio|1.89|||||TWO_SIDED|90.0|1.18|3.03|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as a multiplier in the Modified Diet in Renal Disease Study Group (MDRD) equation.|||3.03|1.18|
73981443|NCT00999336|147507873|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.27|||||TWO_SIDED|90.0|1.43|3.59|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||3.59|1.43|
74033505|NCT00436969|147619870|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.79||||0.41|TWO_SIDED|95.0|-9.441|3.861||The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.||3.861|-9.441|0.410
74033506|NCT00436969|147619871|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.617||||0.379|TWO_SIDED|95.0|-3.226|8.46||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||8.460|-3.226|0.379
74033507|NCT00436969|147619872|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.208||||0.409|TWO_SIDED|95.0|-7.455|3.039||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.039|-7.455|0.409
73873743|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
73954496|NCT04319094|147443741|SUPERIORITY||Mean Difference (Net)|4.57||||0.18|TWO_SIDED|95.0|-2.08|11.21||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|11.21|-2.08|0.18
73954497|NCT04319094|147443741|SUPERIORITY||Mean Difference (Net)|1.57|STANDARD_ERROR_OF_MEAN|3.29||0.63|TWO_SIDED|95.0|-4.89|8.04||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|8.04|-4.89|0.63
73954498|NCT04319094|147443741|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|3.01||0.74|TWO_SIDED|95.0|-6.94|4.91||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.91|-6.94|0.74
73981444|NCT00999336|147507873|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.63|||||TWO_SIDED|90.0|1.71|4.06|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.06|1.71|
73981445|NCT00999336|147507873|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.39|||||TWO_SIDED|90.0|0.888|2.18|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||2.18|0.888|
73981446|NCT00999336|147507873|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.94|||||TWO_SIDED|90.0|1.14|3.31|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||3.31|1.14|
73981447|NCT00999336|147507873|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.44|||||TWO_SIDED|90.0|1.41|4.22|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.22|1.41|
73981448|NCT00999336|147507873|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.86|||||TWO_SIDED|90.0|1.74|4.7|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.7|1.74|
73981449|NCT00999336|147507873|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.47|||||TWO_SIDED|90.0|0.944|2.3|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||2.3|0.944|
74033508|NCT00436969|147619873|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.558||||0.232|TWO_SIDED|95.0|-4.119|1.003||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||1.003|-4.119|0.232
74033509|NCT00436969|147619874|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.228||||0.832|TWO_SIDED|95.0|-2.343|1.887||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||1.887|-2.343|0.832
74033510|NCT00436969|147619875|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.068||||0.957|TWO_SIDED|95.0|-2.396|2.532||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||2.532|-2.396|0.957
74039498|NCT02528253|147632445|SUPERIORITY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1089|TWO_SIDED|95.0|-1.84|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-1.84|0.1089
73873744|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.44|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.44
73873745|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
73954499|NCT04319094|147443741|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|3.83||0.85|TWO_SIDED|95.0|-6.82|8.23||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|8.23|-6.82|0.85
73954500|NCT04319094|147443741|SUPERIORITY|||||||0.3988|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of physical functioning over time between the control and PEERS participants.||||0.3988
73954501|NCT04319094|147443742|SUPERIORITY||Mean Difference (Net)|5.08|STANDARD_ERROR_OF_MEAN|3.41||0.14|TWO_SIDED|95.0|-1.63|11.79||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|11.79|-1.63|0.14
73954502|NCT04319094|147443742|SUPERIORITY||Mean Difference (Net)|10.32|STANDARD_ERROR_OF_MEAN|4.0||0.01|TWO_SIDED|95.0|2.45|18.19||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|18.19|2.45|0.01
73954503|NCT04319094|147443742|SUPERIORITY||Mean Difference (Net)|10.25|STANDARD_ERROR_OF_MEAN|4.19||0.015|TWO_SIDED|95.0|2.01|18.5||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|18.5|2.01|0.015
73954504|NCT04319094|147443742|SUPERIORITY||Mean Difference (Net)|11.72|STANDARD_ERROR_OF_MEAN|4.07||0.004|TWO_SIDED|95.0|3.7|19.73||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|19.73|3.7|0.004
73981450|NCT00999336|147507874|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.88|||||TWO_SIDED|90.0|1.05|3.35|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||3.35|1.05|
73981451|NCT00999336|147507874|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.32|||||TWO_SIDED|90.0|1.32|4.07|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.07|1.32|
73981452|NCT00999336|147507874|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.52|||||TWO_SIDED|90.0|1.48|4.29|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.29|1.48|
73981453|NCT00999336|147507874|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.34|||||TWO_SIDED|90.0|0.772|2.32|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||2.32|0.772|
73981454|NCT00999336|147507874|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.96|||||TWO_SIDED|90.0|1.01|3.78|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||3.78|1.01|
73981455|NCT00999336|147507874|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.38|||||TWO_SIDED|90.0|1.21|4.67|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.67|1.21|
73981456|NCT00999336|147507874|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.69|||||TWO_SIDED|90.0|1.46|4.96|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.96|1.46|
73981457|NCT00999336|147507874|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.37|||||TWO_SIDED|90.0|0.793|2.38|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||2.38|0.793|
73981458|NCT02159352|147507884|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.384|||||TWO_SIDED|90.0|0.348|0.423||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.||0.423|0.348|
73873746|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
73873747|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73873748|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
73873749|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
73954505|NCT04319094|147443742|SUPERIORITY||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|4.49||0.2|TWO_SIDED|95.0|-3.09|14.55||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|14.55|-3.09|0.2
73954506|NCT04319094|147443742|SUPERIORITY|||||||0.8037|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of social functioning over time between the control and PEERS participants.||||0.8037
73954507|NCT04319094|147443743|SUPERIORITY||Median Difference (Net)|12.52|STANDARD_ERROR_OF_MEAN|5.01||0.0129|TWO_SIDED|95.0|2.67|22.37||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|22.37|2.67|0.0129
73954508|NCT04319094|147443743|SUPERIORITY||Mean Difference (Net)|19.84|STANDARD_ERROR_OF_MEAN|5.86||0.0008|TWO_SIDED|95.0|8.32|31.36||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|31.36|8.32|0.0008
73981459|NCT02159352|147507884|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.337|||||TWO_SIDED|90.0|0.306|0.371||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.||0.371|0.306|
73981460|NCT02159352|147507885|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.703|||||TWO_SIDED|90.0|0.658|0.75||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).||0.750|0.658|
73981461|NCT02159352|147507885|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.577|||||TWO_SIDED|90.0|0.535|0.622||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).||0.622|0.535|
73981462|NCT02159352|147507888|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.768|||||TWO_SIDED|90.0|0.697|0.846||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.||0.846|0.697|
73981463|NCT02159352|147507888|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.673|||||TWO_SIDED|90.0|0.611|0.742||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.||0.742|0.611|
73981464|NCT02159352|147507889|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|1.406|||||TWO_SIDED|90.0|1.317|1.501||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).||1.501|1.317|
73873750|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73873751|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
73873752|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
73873753|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
73873754|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
73873755|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
73873756|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
73954509|NCT04319094|147443743|SUPERIORITY||Median Difference (Net)|17.99|STANDARD_ERROR_OF_MEAN|6.14||0.0036|TWO_SIDED|95.0|5.92|30.06||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|30.06|5.92|0.0036
73954510|NCT04319094|147443743|SUPERIORITY||Median Difference (Net)|16.24|STANDARD_ERROR_OF_MEAN|5.98||0.007|TWO_SIDED|95.0|4.47|28.01||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|28.01|4.47|0.007
73954511|NCT04319094|147443743|SUPERIORITY||Mean Difference (Net)|12.26|STANDARD_ERROR_OF_MEAN|6.58||0.065|TWO_SIDED|95.0|-0.68|25.19||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|25.19|-0.68|0.065
73954512|NCT04319094|147443743|SUPERIORITY|||||||0.881|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of emotional functioning over time between the control and PEERS participants.||||0.8810
73954513|NCT04319094|147443744|SUPERIORITY|||||||0.031||||||The a priori threshold for statistical significance is p=0.05.|F-test for overall significance|Degrees of freedom: 370||Null hypothesis: there is no difference in the change in probability of ER use from baseline to post-intervention between PEERS and control participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|||0.031
73954514|NCT04319094|147443749|SUPERIORITY||Mean Difference (Net)|-4.98|STANDARD_ERROR_OF_MEAN|1.42||0.0005|TWO_SIDED|95.0|-7.78|-2.18||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-2.18|-7.78|0.0005
73954515|NCT04319094|147443749|SUPERIORITY||Mean Difference (Net)|-7.38|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.08|-3.69||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-3.69|-11.08|<0.0001
73954516|NCT04319094|147443749|SUPERIORITY||Mean Difference (Net)|-7.63|STANDARD_ERROR_OF_MEAN|1.87|<|0.0001|TWO_SIDED|95.0|-11.3|-3.95||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-3.95|-11.3|<0.0001
74089600|NCT02791893|147731971|SUPERIORITY|||||||0.23||||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was an independent t-test comparing the conditions on their perception of change since starting the intervention.||"A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase were assigned a score of 1 indicating no change in their condition. Post-intervention PGIC scores were compared between conditions."||||0.23
73873757|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
73954517|NCT04319094|147443749|SUPERIORITY||Mean Difference (Net)|-8.12|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-11.53|-4.7||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-4.7|-11.53|<0.0001
73954518|NCT04319094|147443749|SUPERIORITY||Mean Difference (Net)|-8.26|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-12.37|-4.14||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-4.14|-12.37|<0.0001
73954519|NCT04319094|147443749|SUPERIORITY|||||||0.6857|||||||Mixed Models Analysis|||Null hypothesis: there is no statistical difference in the change of UCLA Loneliness score over time between control and PEERS participants||||0.6857
73954520|NCT04319094|147443750|SUPERIORITY||Mean Difference (Net)|1.79|STANDARD_ERROR_OF_MEAN|0.54||0.001|TWO_SIDED|95.0|0.72|2.86|||Mixed Models Analysis|Degrees of freedom: 421|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.86|0.72|0.001
73954521|NCT04319094|147443750|SUPERIORITY||Mean Difference (Net)|0.93|STANDARD_ERROR_OF_MEAN|0.67||0.18|TWO_SIDED|95.0|-0.39|2.25||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.25|-0.39|0.18
73954522|NCT04319094|147443750|SUPERIORITY||Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.68||0.11|TWO_SIDED|95.0|-0.24|2.45||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.45|-0.24|0.11
73954523|NCT04319094|147443750|SUPERIORITY||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|0.65||0.0006|TWO_SIDED|95.0|0.98|3.54||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|3.54|0.98|0.0006
74033511|NCT00436969|147619876|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.22||||0.267|TWO_SIDED|95.0|-0.937|3.378||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.378|-0.937|0.267
74033512|NCT00436969|147619877|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.19||||0.333|TWO_SIDED|95.0|-1.225|3.604||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||3.604|-1.225|0.333
74033513|NCT00436969|147619878|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.771||||0.473|TWO_SIDED|95.0|-1.339|2.881||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||2.881|-1.339|0.473
73873758|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
73873759|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
73873760|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
73954524|NCT04319094|147443750|SUPERIORITY||Mean Difference (Net)|2.48|STANDARD_ERROR_OF_MEAN|0.75||0.001|TWO_SIDED|95.0|1.01|3.95||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|3.95|1.01|0.001
73954525|NCT04319094|147443750|SUPERIORITY|||||||0.1195|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of GSES scores over time between the control and PEERS participants.||||0.1195
73954526|NCT04319094|147443751|SUPERIORITY||Mean Difference (Net)|3.22|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|1.71|4.73||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.73|1.71|<0.0001
73954527|NCT04319094|147443751|SUPERIORITY||Mean Difference (Net)|2.59|STANDARD_ERROR_OF_MEAN|1.03||0.0123|TWO_SIDED|95.0|0.57|4.62||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.62|0.57|0.0123
73954528|NCT04319094|147443751|SUPERIORITY||Mean Difference (Net)|2.63|STANDARD_ERROR_OF_MEAN|1.02||0.01|TWO_SIDED|95.0|0.63|4.63||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.63|0.63|0.01
73954529|NCT04319094|147443751|SUPERIORITY||Mean Difference (Net)|4.18|STANDARD_ERROR_OF_MEAN|0.95|<|0.0001|TWO_SIDED|95.0|2.32|6.04||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|6.04|2.32|<0.0001
73981465|NCT02159352|147507889|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|1.154|||||TWO_SIDED|90.0|1.07|1.244||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).||1.244|1.070|
73981466|NCT01214109|147507912|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|82.62||||||90.0|74.45|91.69|||ANOVA|||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||91.69|74.45|
73873761|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
73873762|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
73873763|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
73873764|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
73873765|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73873766|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
73873767|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
73981467|NCT01214109|147507912|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|96.17||||||90.0|69.33|133.42|||ANOVA|||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||133.42|69.33|
73981468|NCT01214109|147507913|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|88.01||||||90.0|80.76|95.92|||ANOVA|||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||95.92|80.76|
73981469|NCT01214109|147507913|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|89.37||||||90.0|81.16|98.42|||ANOVA|||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||98.42|81.16|
73981470|NCT01214109|147507914|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|88.82||||||90.0|79.89|98.76|||ANOVA|||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||98.76|79.89|
73981471|NCT01214109|147507914|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|91.97||||||90.0|60.07|140.25|||ANOVA|||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||140.25|60.07|
73981472|NCT01214109|147507915|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|92.84||||||90.0|83.8|102.86|||ANOVA|||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||102.86|83.8|
73981473|NCT01214109|147507915|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|95.05||||||90.0|84.88|106.43|||ANOVA|||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||106.43|84.88|
73981474|NCT03032965|147507933|SUPERIORITY|||||||0.83|||||||Log Rank|Kaplan Meier log rank||||||.83
73981475|NCT03032965|147507934|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.35
73981476|NCT03032965|147507936|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
73981477|NCT00636168|147507942|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0013|TWO_SIDED|95.0|0.64|0.9|||Log Rank|stratified 2-sided log-rank test||The hazard ratio, and its 95 % confidence interval was estimated using a Cox proportional hazards model, stratified by stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as indicated at randomization, with treatment as the single covariate.. The analysis was performed after 528 RFS events per IRC were reported. Two-sided, 95% confidence intervals for median RFS were computed by the Brookmeyer and Crowley method using log-log transformation.||0.90|0.64|0.0013
73981478|NCT00636168|147507945|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0024|TWO_SIDED|95.8|0.64|0.92|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.8% confidence interval are based on a stratified Cox proportional hazards model||0.92|0.64|0.0024
73981479|NCT00636168|147507948|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0013|TWO_SIDED|95.1|0.58|0.88|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.1% confidence interval are based on a stratified Cox proportional hazards model||0.88|0.58|0.0013
73981480|NCT02707952|147507954|NON_INFERIORITY|The percentage of participants achieving SVR12 was calculated for each arm and a 2-sided 95% CI for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the confidence interval (CI) for the difference was above the non-inferiority margin of -10%, then arm A was considered non-inferior to arm B.|Rate Difference|-0.9|||||TWO_SIDED|95.0|-2.8|0.9|||||95% CI was calculated using the normal approximation to the binomial distribution.|||0.9|-2.8|
73981481|NCT02006641|147507966|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.51||1|TWO_SIDED|95.0|-1.1|0.92||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.92|-1.10|1.000
74033514|NCT00436969|147619879|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.018||||0.988|TWO_SIDED|95.0|-2.314|2.278||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||2.278|-2.314|0.988
73873768|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
73873769|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.72|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.72
73873770|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73981482|NCT02006641|147507966|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.52||0.2223|TWO_SIDED|95.0|-0.38|1.65||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.65|-0.38|0.2223
73954530|NCT04319094|147443751|SUPERIORITY||Mean Difference (Net)|3.14|STANDARD_ERROR_OF_MEAN|1.17||0.0078|TWO_SIDED|95.0|0.83|5.44||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|5.44|0.83|0.0078
73954531|NCT04319094|147443751|SUPERIORITY|||||||0.1408|||||||Mixed Models Analysis|||Null hypothesis: there is no statistical difference in the change in adaptive coping over time between control and PEERS participants.||||0.1408
73954532|NCT01016353|147443754|SUPERIORITY|||||||0.06|||||||Log Rank|||||||0.06
73954533|NCT02487446|147443755|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) \> -20 mL.|Mean Difference (Net)|-0.0115|STANDARD_ERROR_OF_MEAN|0.00778||0.139|TWO_SIDED|95.0|-0.0269|0.0038||p-value unadjusted|Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||0.0038|-0.0269|0.139
73954534|NCT02487446|147443756|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0115|STANDARD_ERROR_OF_MEAN|0.00778|||TWO_SIDED|95.0|-0.0269|0.0038||||||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||0.0038|-0.0269|
73954535|NCT02487446|147443757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0153|STANDARD_ERROR_OF_MEAN|0.01062|||TWO_SIDED|95.0|-0.0361|0.0056||||||||0.0056|-0.0361|
74009152|NCT04666350|147569059|OTHER||Combined Difference in Prevalence|-0.023||||0.75|TWO_SIDED|95.0|-0.164|0.118|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.118|-0.164|0.750
73954536|NCT02487446|147443758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0051|STANDARD_ERROR_OF_MEAN|0.00806|||TWO_SIDED|95.0|-0.0108|0.0209||||||||0.0209|-0.0108|
73954537|NCT01822821|147443764|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was tested using a noninferiority margin of 1.15.|ratio of geometric means|0.89||||0.08|ONE_SIDED|90.0||1.06|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.|||1.06||0.08
73954538|NCT01822821|147443764|SUPERIORITY_OR_OTHER||ratio of geometric means|0.89||||0.28|ONE_SIDED|95.0||1.1|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.|||1.10||0.28
73954539|NCT01822821|147443765|NON_INFERIORITY_OR_EQUIVALENCE|We assessed whether IV acetaminophen is noninferior to placebo using a noninferiority margin of 1.0.|Median Difference (Final Values)|-0.9|||<|0.001|ONE_SIDED|90.0||-0.5|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.|||-0.5||< 0.001
73954540|NCT01822821|147443765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||<|0.001|ONE_SIDED|95.0||-0.42|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.|||-0.42||< 0.001
73954541|NCT01822821|147443766|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76||||0.35|TWO_SIDED|99.4|0.34|1.7|||Regression, Logistic||Relative risk of PONV in IV acetaminophen versus placebo patients estimated from a multivariable logistic regression model using the log link and adjusting for age and diabetes.|||1.7|0.34|0.35
73954542|NCT01822821|147443767|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.13|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 8 hours after surgery.||0|0|0.13
73954543|NCT01822821|147443767|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.44|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 16 hours after surgery.||0|0|0.44
73954544|NCT01822821|147443767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.38|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 24 hours after surgery||0|0|0.38
73954545|NCT01822821|147443768|SUPERIORITY_OR_OTHER||ratio of geometric means|1.3||||0.46|TWO_SIDED|99.4|0.52|3.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||3.20|0.52|0.46
73873771|NCT01128426|147289452|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873772|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73873773|NCT01128426|147289452|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
73873774|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73954546|NCT01822821|147443769|SUPERIORITY_OR_OTHER||ratio of geometric means|0.93||||0.38|TWO_SIDED|99.4|0.74|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of ICU stay was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||1.20|0.74|0.38
73954547|NCT01822821|147443770|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.12|TWO_SIDED|99.4|0.94|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||1.20|0.94|0.12
73981483|NCT02006641|147507967|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.65||1|TWO_SIDED|95.0|-1.11|1.46||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.46|-1.11|1.000
73981484|NCT02006641|147507967|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.27|1.33||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.33|-1.27|1.000
73981485|NCT02006641|147507968|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||1|TWO_SIDED|95.0|-0.23|0.1||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.10|-0.23|1.000
74009153|NCT04666350|147569059|OTHER||Combined Difference in Prevalence|-0.031||||0.681|TWO_SIDED|95.0|-0.178|0.117|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.117|-0.178|0.681
73954548|NCT01822821|147443771|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.31|TWO_SIDED|99.4|0.9|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on ALT was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.2|0.9|0.31
73954549|NCT01822821|147443772|SUPERIORITY_OR_OTHER||ratio of geometric means|1.0||||0.98|TWO_SIDED|99.4|0.8|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on AST was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.2|0.8|0.98
73873775|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
73873776|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
73873777|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
73873778|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
73873779|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
73873780|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73981486|NCT02006641|147507968|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.12|0.21||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.21|-0.12|1.000
73981487|NCT01297595|147508006|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.58|||||TWO_SIDED|90.0|91.08|108.87||||||Natural log transformed AUC (0 - ∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||108.87|91.08|
73981488|NCT01297595|147508008|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.35|||||TWO_SIDED|90.0|90.51|109.07||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||109.07|90.51|
73981489|NCT01297595|147508009|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|96.84|||||TWO_SIDED|90.0|88.22|106.32||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||106.32|88.22|
73981490|NCT01047709|147508055|SUPERIORITY_OR_OTHER||relative % difference|19.5|STANDARD_DEVIATION|23.0||0.011|TWO_SIDED|95.0|4.9|31.9|||GEE||SD of control night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.||31.9|4.9|0.011
73981491|NCT01047709|147508055|SUPERIORITY_OR_OTHER||Relative % difference|19.5|STANDARD_DEVIATION|16.0||0.011||95.0|4.9|31.9|||GEE||SD of intervention night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.||31.9|4.9|0.011
73981492|NCT03015220|147508076|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.5||||0.2963|TWO_SIDED|95.0|0.7|3.2||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||3.20|0.70|0.2963
73981493|NCT03015220|147508076|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.8||||0.5997|TWO_SIDED|95.0|0.35|1.83||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.83|0.35|0.5997
73981494|NCT03015220|147508076|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.55||||0.1871|TWO_SIDED|95.0|0.23|1.33||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.33|0.23|0.1871
73981495|NCT03015220|147508077|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.9||||0.1672|TWO_SIDED|95.0|0.76|4.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||4.72|0.76|0.1672
73981496|NCT03015220|147508077|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.6||||0.3391|TWO_SIDED|95.0|0.21|1.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.72|0.21|0.3391
73873781|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
73873782|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
73981497|NCT03015220|147508077|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.12||||0.011|TWO_SIDED|95.0|0.02|0.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.62|0.02|0.0110
73873783|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
73954550|NCT01822821|147443773|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.4|TWO_SIDED|99.4|0.87|1.3|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on bilirubin was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.3|0.87|0.40
73954551|NCT05780047|147443774|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73954552|NCT05780047|147443775|OTHER||||||<|0.05|||||||paired samples t-test|||Paired samples t-tests were run to compare whether EHL knowledge, attitudes and behavior changed after the intervention. EHL scores were expected to increase between pre and post testing.||||<0.05
73954553|NCT02081365|147443799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|0.74|3.55|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||3.55|.74|<0.05
73954554|NCT02081365|147443800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|||<|0.05|TWO_SIDED|95.0|0.39|1.57|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.57|.39|<0.05
73954555|NCT02081365|147443801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.05|TWO_SIDED|95.0|0.61|1.85|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.85|.61|<0.05
73954556|NCT02081365|147443802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.05|TWO_SIDED|95.0|0.01|1.64|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.64|.01|<0.05
73954557|NCT01394991|147443803|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.018||||0.248|TWO_SIDED|95.0|-0.051|0.016|||Chi-squared|||The primary hypothesis was that the group of participants receiving epoetin alfa QW and the group of participants receiving epoetin alfa TIW would have similar incidence rate of participants with at least 1 clinically relevant and objectively confirmed TVE from randomization through Week 16.||0.016|-0.051|0.248
73954558|NCT01394991|147443803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.254||95.0|0.18|1.58|||Regression, Logistic|||||1.58|0.18|0.254
73954559|NCT01394991|147443804|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.029||||0.08|TWO_SIDED|95.0|-0.065|0.007|||Chi-squared|||||0.007|-0.065|0.08
73954560|NCT01394991|147443805|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.073|TWO_SIDED|95.0|0.14|1.13|||Log Rank|The stratified log-rank test accounting for ECOG performance status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model with covariates for treatment group and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 versus 2) was used for estimates of hazard ratio and its 95% confidence interval.|||1.13|0.14|0.073
73954561|NCT01394991|147443806|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.039||||0.059||95.0|-0.083|0.005|||Chi-squared|||||0.005|-0.083|0.059
73954562|NCT01394991|147443807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47||||0.054|TWO_SIDED|95.0|0.21|1.03|||Log Rank|The stratified log-rank test accounting for ECOG score status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model including covariates for treatment group and the Eastern Cooperative Oncology Group (ECOG) score status (0 or 1 versus 2) was used for estimates of a hazard ratio and its 95% confidence interval.|||1.03|0.21|0.054
73954563|NCT01394991|147443808|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0041||||0.88||95.0|-0.0526|0.0608|||Chi-squared|||||0.0608|-0.0526|0.88
73954564|NCT01394991|147443809|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.026||||0.514|TWO_SIDED|95.0|-0.056|0.108|||Chi-squared|||||0.108|-0.056|0.514
73954565|NCT01394991|147443810|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.003||||0.92|TWO_SIDED|95.0|-0.071|0.065|||Chi-squared|||||0.065|-0.071|0.920
73954566|NCT01324882|147443829|OTHER|||||||1|||||||Fisher Exact|||||||1.00
73954567|NCT01866917|147443940|SUPERIORITY|||||||0.574|||||||Chi-squared|||||||.574
73954568|NCT01866917|147443941|SUPERIORITY|Statistical analysis performed using SPSS software, version 15 (SPSS Inc., Chicago, IL). Data for quantitative variables reported as a median and interquartile range. The Mann Whitney and chi-square tests were used for the analysis of continuous and categorical variables.|Interquartile range (IQR)|3.0||||0.825|TWO_SIDED|||||Effect size was calculated for the numeric pain rating scale at the immediate post-operative period, 4-hour, 8-hour , 12-hour, and 24-hour time periods as a means to assess post-operative pain control.|Chi-squared|||TAP has been demonstrated to have a potential role in reducing pain, post-operative opioid requirement, and time to hospital discharge after abdominal hysterectomies and cesarean sections.||||.825
73873784|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
73954569|NCT03253653|147443942|OTHER||z score|1.578||||0.115|TWO_SIDED||||||Wilcoxon signed-rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.115
73954570|NCT03253653|147443943|OTHER||z|0.497||||0.619|TWO_SIDED||||||z||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.619
73954571|NCT03253653|147443944|OTHER||z|1.72||||0.085|TWO_SIDED||||||Wilcox and signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.085
74039499|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1472|TWO_SIDED|95.0|-0.18|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.18|0.1472
73873785|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
73873786|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
73873787|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
73873788|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.49|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.49
73954572|NCT03253653|147443945|OTHER||z|6.154|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||<0.001
73954573|NCT03253653|147443946|OTHER||z|-1.144||||0.253|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in systolic blood pressure for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.253
73954574|NCT03253653|147443947|OTHER||z|-1.004||||0.315|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in diastolic blood pressure for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in diastolic blood pressure for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.315
73954575|NCT03253653|147443948|OTHER||z|3.089||||0.002|TWO_SIDED||||||Wilcox and signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in heart rate for the Charcoal-heated tobacco smoking session (n=50) was significantly different from the pre-to-post change in heart rate for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.002
73981498|NCT02291549|147508094|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.0074|TWO_SIDED|95.0|-0.39|-0.06||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparison.|ANCOVA|Where appropriate, confidence intervals of the difference were constructed using the estimate of the least-squares means||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the Nasal Obstruction/Congestion score compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.06|-0.39|0.0074
73981499|NCT02291549|147508095|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.0073|TWO_SIDED|95.0|-0.6|-0.09||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparisons.|ANCOVA|ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.||The between treatment group difference was estimated using the ANCOVA model with site and treatment group as fixed effects. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the bilateral polyp grade compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.09|-0.60|0.0073
73981500|NCT02291549|147508096|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0004|TWO_SIDED|95.0|1.63|4.44||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted p-value is presented.||Test: H0: OR = 1 vs. OR ≠ 1 by Cochrane-Mantel-Haenszel test||4.44|1.63|0.0004
73873789|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
73873790|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
73873791|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
73873792|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
73873793|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
73873794|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
73873795|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
73873796|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
73954576|NCT03253653|147443949|OTHER||z|-7.024|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
73873797|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.45
73873798|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
73873799|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
73873800|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
73873801|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873802|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
73981501|NCT02291549|147508097|SUPERIORITY||Mean Difference (Final Values)|-7.96||||0.0007|TWO_SIDED|95.0|-12.1|-3.83||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.The null hypothesis was H0: β1 = 0 and the alternative hypothesis was H1: β1 ≠ 0. Although the alternative hypothesis was specified as 2-sided, only a statistically significant, negative estimate of β1 constituted evidence of effectiveness. The 2-sided alpha for this test was 0.05.||-3.83|-12.10|0.0007
73981502|NCT02291549|147508098|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.0248|TWO_SIDED|95.0|-0.48|-0.07||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and the alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.07|-0.48|0.0248
73981503|NCT02291549|147508099|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.047|TWO_SIDED|95.0|-0.85|-0.06||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|The adjusted p-value is presentenced.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.06|-0.85|0.0470
74089601|NCT02791893|147731971|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.23|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was an independent t-test comparing the conditions on their perception of change since starting the intervention.|Condition difference = Active - Sham|Below are the results of the per protocol analysis. Post-intervention PGIC scores were compared between conditions.||||0.23
73873803|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
73873804|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
73873805|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73873806|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
73873807|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
73873808|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873809|NCT01128426|147289453|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873810|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
73873811|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
73873812|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
73873813|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
73873814|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
73873815|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
73873816|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
73873817|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
73954577|NCT03253653|147443950|OTHER||z|-4.541|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the SPMA metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
73954578|NCT03253653|147443951|OTHER||z|-2.569||||0.01|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the 1-HOP metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||.010
73954579|NCT03253653|147443952|OTHER||z|-7.03|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the exhaled carbon monoxide after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
73954580|NCT03253653|147443953|OTHER||z|-1.304||||0.192|TWO_SIDED||||||Mann-Whitney U test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.192
73954581|NCT03253653|147443954|OTHER||z|-2.136||||0.033|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level diastolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.033
73954582|NCT03253653|147443955|OTHER||z|-1.22||||0.223|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the heart rate after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.223
73954583|NCT03253653|147443956|OTHER||z|-7.024|||<|0.001|TWO_SIDED||||||Mann Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
73954584|NCT03253653|147443957|OTHER||z|-1.248||||0.212|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the SPMA metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.212
73954585|NCT03253653|147443958|OTHER||z|-2.721||||0.007|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.007
73954586|NCT03253653|147443959|OTHER||z|2.778||||0.006|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of exhaled carbon monoxide after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.006
73981504|NCT02291549|147508100|SUPERIORITY|||||||0.913||||||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||||0.9130
73981505|NCT01697956|147508105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of BDP nasal aerosol versus placebo was greater than 0.80.|ratio of BDP nasal aerosol to placebo|0.91|||||TWO_SIDED|95.0|0.81|1.03||||||The standard deviation of the logarithmically transformed data on the change from baseline (expressed as a ratio) in 24-hr serum cortisol weighted mean is assumed to be 0.30. Using this standard deviation, 90 subjects (approximately 60 and 30 subjects in the BDP Nasal Aerosol and placebo groups, respectively) will yield approximately 90% power to demonstrate non-inferiority between BDP Nasal Aerosol and placebo, if there is no true difference between treatment groups.||1.03|0.81|
73981506|NCT04447287|147508141|OTHER||Geometric LS Mean Ratio|89.72|||||TWO_SIDED|90.0|81.21|99.11||||||||99.11|81.21|
73981507|NCT04447287|147508142|OTHER||Geometric LS Mean Ratio|92.15|||||TWO_SIDED|90.0|80.22|105.86||||||||105.86|80.22|
74089602|NCT02791893|147731972|SUPERIORITY||Mean Difference (Final Values)|12.88||||0.13|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention physical function scores was regressed on pre-intervention physical function and condition, using an ANCOVA model.||||0.13
73981508|NCT04447287|147508143|OTHER||Geometric LS Mean Ratio|109.09|||||TWO_SIDED|90.0|101.1|117.71||||||||117.71|101.10|
73873818|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
73954587|NCT03253653|147443960|OTHER||z|-0.832||||0.406|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of systolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.406
73954588|NCT03253653|147443961|OTHER||z|-1.467||||0.142|TWO_SIDED||||||Mann-Whitney U ranksum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of diastolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.142
73954589|NCT03253653|147443962|OTHER||z|-0.596||||0.551|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the heart rate after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.551
73981509|NCT04447287|147508144|OTHER||Geometric LS Mean Ratio|117.77|||||TWO_SIDED|90.0|106.41|130.34||||||||130.34|106.41|
73981510|NCT04447287|147508145|OTHER||Geometric LS Mean Ratio|79.39|||||TWO_SIDED|90.0|68.1|92.55||||||||92.55|68.10|
73954590|NCT03253653|147443963|OTHER||z|-0.787||||0.431|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.431
73954591|NCT03253653|147443964|OTHER||z|-0.652||||0.515|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.515
73954592|NCT03253653|147443965|OTHER||z|-2.394||||0.017|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0. 017
73954593|NCT03253653|147443966|OTHER||z|-1.286||||0.199|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.199
73954594|NCT03253653|147443967|OTHER||z|-3.091||||0.002|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.002
73954595|NCT03253653|147443968|OTHER||z|0.13||||0.896|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.896
73954596|NCT03253653|147443969|OTHER||z|-0.362||||0.717|TWO_SIDED||||||The Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.717
73954597|NCT03253653|147443970|OTHER||z|2.233||||0.026|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.026
73954598|NCT03253653|147443971|OTHER||z|0.383||||0.702|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.702
73981511|NCT04447287|147508146|OTHER||Geometric LS Mean Ratio|74.45|||||TWO_SIDED|90.0|59.28|93.5||||||||93.50|59.28|
73954599|NCT03253653|147443972|OTHER||z|2.244||||0.025|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.025
73954600|NCT00929305|147443973|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73954601|NCT00929305|147443976|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73954602|NCT01251614|147444014|SUPERIORITY_OR_OTHER||Difference|-25.5||||0.027|TWO_SIDED|95.0|-47.2|-3.7|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~1. Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~2. Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."||-3.7|-47.2|0.027
73954603|NCT01251614|147444015|SUPERIORITY_OR_OTHER||Difference|-20.0||||0.083|TWO_SIDED|95.0|-42.2|2.2|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~1. Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~2. Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."||2.2|-42.2|0.083
73954604|NCT01251614|147444016|SUPERIORITY_OR_OTHER||Difference|-7.3||||0.466|TWO_SIDED|95.0|-26.9|12.3|||Chi-squared|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||12.3|-26.9|0.466
73954605|NCT01251614|147444017|SUPERIORITY_OR_OTHER||Difference|-15.7||||0.056|TWO_SIDED|95.0|-29.1|-2.3|||Fisher Exact|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||-2.3|-29.1|0.056
73954606|NCT01251614|147444018|SUPERIORITY_OR_OTHER||Difference|1.61||||0.304|TWO_SIDED|95.0|-1.48|4.7|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||4.70|-1.48|0.304
73954607|NCT01251614|147444019|SUPERIORITY_OR_OTHER||Difference|-8.88||||0.005|TWO_SIDED|95.0|-14.94|-2.82|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||-2.82|-14.94|0.005
73954608|NCT01251614|147444020|SUPERIORITY_OR_OTHER||Difference|-28.3||||0.113|TWO_SIDED|95.0|-60.6|4.0|||Chi-squared|||"The difference between the combined adalimumab 0.8 mg/kg + MTX groups versus the adalimumab 0.4 mg/kg group.~Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were to be 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank."||4.0|-60.6|0.113
73954609|NCT01251614|147444021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.343|TWO_SIDED|95.0|0.66|3.17|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||3.17|0.66|0.343
74033515|NCT00436969|147619880|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.467||||0.671|TWO_SIDED|95.0|-1.692|2.627||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||2.627|-1.692|0.671
74033516|NCT00905307|147619881|SUPERIORITY_OR_OTHER||Treatment difference|-4.7||||0.2846|TWO_SIDED|95.0|-10.2|0.82||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.82|-10.2|0.2846
73954610|NCT01251614|147444021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.276|TWO_SIDED|95.0|0.71|3.21|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||3.21|0.71|0.276
73954611|NCT02688621|147444055|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||The study was designed to detect a 2.2-kg group weight loss difference between groups with a standard deviation of 5.8 kg,4,5 a 5% Type I error rate, and 80% power. To adjust for possible clustering effects in this nested design, the adjusted variance estimate was increased to 7.67, calculated using a conservative intraclass correlation coefficient of 0.05.||||<.01
73954612|NCT02851511|147444088|SUPERIORITY|tDCS vs. sham superiority with cognitive training will be tested based on the 320 participants who are assigned to the two cognitive training arms. The effects of tDCS on changes in NIH Toolbox Fluid Cognition Composite Score (NIHTB FCC) from baseline to 3-month follow-up are estimated by linear regression models, with missing outcomes predicted by regression models that include demographic and baseline characteristics.|Slope|0.33|STANDARD_ERROR_OF_MEAN|0.63|<|0.05|TWO_SIDED|95.0|-0.91|1.56||Formal statistical inference of the tDCS effect was based on the inverse-normal combination of two p-values, one from the Phase I data (N=42) and the other from the Phase II data (N=292).|Regression, Linear|||"Null hypothesis: The combination of cognitive training (12 weeks) and active stimulation (over the dorsolateral prefrontal cortex) will not lead to beneficial changes on the NIH Toolbox Cognition Battery.~The study is designed to have at least 90% power to detect a difference of effect size 0.42 between cognitive training+tDCS and cognitive training+sham, using a normal inverse combination test at one-sided 0.025 level."||1.56|-0.91|<0.05
73981512|NCT03246724|147508151|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. A 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||As a sensitivity analysis, an ANCOVA model will be fit to the data adjusting for factors that are out of balance following randomization. The mean difference between the adjusted means will be calculated.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV.||"Testable hypothesis: Patient satisfaction mean will be non-inferior when given oral triazolam in comparison to IV midazolam during all basic cataracts, retina, cornea, and glaucoma ocular procedures.~Null hypothesis: The null hypothesis is that the oral sedation group will have a primary endpoint mean equal to or less than that of the IV sedation group by the non-inferiority margin or more."||||<0.05
74009154|NCT00097773|147569072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.86|TWO_SIDED|95.0|0.54|1.66||There was no significant interaction with ciprofloxacin in this analysis.|Regression, Cox||risk of exacerbation comparing cycled therapy to culture-based therapy|The primary analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation requiring IV antibiotics or hospitalization. Assuming a total sample size of 300 (150 per group), the study provided 80% power to detect at least a 40% reduction in the risk of exacerbation in the cycled group as compared to the culture-based group at the two-sided alpha level of 5%.||1.66|0.54|0.86
74009155|NCT00097773|147569072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.2|TWO_SIDED|95.0|0.82|2.54|||Regression, Cox||risk of exacerbation comparing oral cipro to oral placebo|A secondary comparison was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.||2.54|0.82|0.20
73954613|NCT02584790|147444094|OTHER|||||||0.004|||||||Chi-squared|||2x2 table of: Row: 1. NBI suspicious pattern 2. NBI non-suspicious pattern Category: 1. with residual disease 2. without residual disease||||0.004
73954614|NCT01928940|147444120|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
73954615|NCT01928940|147444120|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR|||99.6|35.9|<0.0001
73873819|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873820|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
73981513|NCT03246724|147508152|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||Surgeon satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, oral sedation will be deemed non-inferior to IV.||"Null hypothesis: Mean surgeon satisfaction score for oral triazolam will be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures.~Alternate hypothesis: Mean surgeon satisfaction score for oral triazolam will not be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures."||||<0.05
73981514|NCT03246724|147508153|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||Anesthesiologist/CRNA satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV.||"Null hypothesis: Mean anesthesiologist/CRNA satisfaction score for oral triazolam will be statistically significant in comparison to mean anesthesiologist/CRNA satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures.~Alternate hypothesis:Mean anesthesiologist/CRNA satisfaction score for oral triazolam will not be statistically significant in comparison to mean satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures."||||<0.05
73981515|NCT03246724|147508154|OTHER|Additional anesthesia intervention will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals.|||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis:The total additional anesthesia interventions for oral triazolam will be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures.~Alternate hypothesis:The total additional anesthesia interventions for oral triazolam will not be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures"||||<0.05
73981516|NCT03246724|147508155|OTHER|Surgical complications will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals.|||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis: The total surgical complications for oral triazolam will be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures.~Alternate hypothesis: The total surgical complications for oral triazolam will not be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures."||||<0.05
73981517|NCT02978716|147508156|SUPERIORITY||Mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.7048|TWO_SIDED|95.0|-0.8|1.5||A Hochberg-based gatekeeping procedure was used to control the global family-wise error rate across the multiple null hypotheses in the strong sense at a 1-sided 0.025 level.|Analysis of covariance (ANCOVA)|||Duration of SN in Cycle 1 in Group 3 vs Group 1.||1.5|-0.8|0.7048
73981518|NCT02978716|147508156|SUPERIORITY||Mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.71||0.3364|TWO_SIDED|95.0|-0.6|2.3||2-sided p-value was calculated using a ANCOVA with study baseline ANC value as covariate, stratification factors of lines of systemic therapy, liver involvement and treatment as fixed effects.|ANCOVA|||Duration of SN in Cycle 1 in Group 2 vs Group 1.||2.3|-0.6|0.3364
74089603|NCT02791893|147731972|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.12|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention physical function scores was regressed on pre-intervention physical function and condition, using an ANCOVA model.||||0.12
73954616|NCT01928940|147444125|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
73873821|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
73873822|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
73873823|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
73954617|NCT01928940|147444125|SUPERIORITY_OR_OTHER||Percentage|50.0||||0.0158|TWO_SIDED|95.0|11.8|82.2|||Exact binomial test||BICR Assessed ORR|||82.2|11.8|0.0158
73954618|NCT01928940|147444126|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
73954619|NCT01928940|147444126|SUPERIORITY_OR_OTHER||Percentage|50.0||||0.0158|TWO_SIDED|95.0|11.8|88.2|||Exact binomial test||BICR Assessed ORR|||88.2|11.8|0.0158
73873824|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
74033517|NCT00905307|147619881|SUPERIORITY_OR_OTHER||Treatment difference|-1.44||||0.6066|TWO_SIDED|95.0|-6.96|4.07||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||4.07|-6.96|0.6066
74033518|NCT00905307|147619881|SUPERIORITY_OR_OTHER||Treatment difference|-3.86||||0.3293|TWO_SIDED|95.0|-9.32|1.59||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.59|-9.32|0.3293
74033519|NCT00905307|147619881|SUPERIORITY_OR_OTHER||Treatment difference|4.62||||0.2263|TWO_SIDED|95.0|-2.89|12.12|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||12.12|-2.89|0.2263
73873825|NCT01128426|147289453|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
73873826|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
73873827|NCT01128426|147289453|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
73873828|NCT01100320|147289462|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|99.9|||||TWO_SIDED|90.0|95.4|104.52|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||104.52|95.40|
73873829|NCT01100320|147289463|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|92.6|||||TWO_SIDED|90.0|90.11|95.09|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||95.09|90.11|
73873830|NCT01100320|147289464|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|92.6|||||TWO_SIDED|90.0|90.13|95.13|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||95.13|90.13|
73873831|NCT00550953|147289465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.02|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|6.41|9.63|||ANCOVA||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus telmisartan 40 mg monotherapy|||9.63|6.41|<0.0001
73954620|NCT01928940|147444129|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
73954621|NCT01928940|147444129|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR|||99.6|35.9|<0.0001
74033520|NCT00905307|147619881|SUPERIORITY_OR_OTHER||Treatment difference|-3.64||||0.3074|TWO_SIDED|95.0|-10.7|3.38|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||||3.38|-10.7|0.3074
74033521|NCT00905307|147619882|SUPERIORITY_OR_OTHER||Treatment difference|1.61||||0.1807|TWO_SIDED|95.0|-0.75|3.97|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||3.97|-0.75|0.1807
74033522|NCT00905307|147619882|SUPERIORITY_OR_OTHER||Treatment difference|-1.41||||0.1313|TWO_SIDED|95.0|-3.24|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.42|-3.24|0.1313
74033523|NCT00905307|147619882|SUPERIORITY_OR_OTHER||Treatment difference|-0.13||||0.8879|TWO_SIDED|95.0|-1.96|1.69|||ANCOVA|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.69|-1.96|0.8879
73954622|NCT02408965|147444149|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
73954623|NCT02408965|147444150|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
73954624|NCT02408965|147444151|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
73954625|NCT02408965|147444152|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
73954626|NCT02408965|147444153|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
73954627|NCT02408965|147444154|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
73954628|NCT02408965|147444155|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73954629|NCT02408965|147444156|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
73981519|NCT02978716|147508157|SUPERIORITY||Adjusted rate ratio|0.776|STANDARD_ERROR_OF_MEAN|0.2762||0.7048|TWO_SIDED|95.0|0.386|1.559||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|Modified Poisson method|||Number of participants with SN in Group 3 vs Group 1.||1.559|0.386|0.7048
73981520|NCT02978716|147508157|SUPERIORITY||Adjusted rate ratio|0.961|STANDARD_ERROR_OF_MEAN|0.364||0.9154|TWO_SIDED|95.0|0.457|2.019||The p-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.|Modified Poisson Regression|||Number of participants with SN in Group 2 vs Group 1.||2.019|0.457|0.9154
73981521|NCT02978716|147508160|SUPERIORITY||Adjusted hazard ratio (HR)|0.4|STANDARD_ERROR_OF_MEAN|0.125||0.0004|TWO_SIDED|95.0|0.22|0.74||P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|stratified log-rank test||Cox regression model.|Overall survival in Group 3 vs Group 1.||0.74|0.22|0.0004
73981522|NCT02978716|147508160|SUPERIORITY||Adjusted HR|0.31|STANDARD_ERROR_OF_MEAN|0.111||0.0016|TWO_SIDED|95.0|0.15|0.63||P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|stratified log-rank test||Cox regression model.|Overall survival in Group 2 vs Group 1.||0.63|0.15|0.0016
73981523|NCT02978716|147508180|SUPERIORITY||Adjusted HR|0.493|STANDARD_ERROR_OF_MEAN|0.1957||0.7048|TWO_SIDED|95.0|0.226|1.073||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||RBC Transfusions in Group 3 vs Group 1.||1.073|0.226|0.7048
73954630|NCT02408965|147444157|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
73954631|NCT04668144|147444183|NON_INFERIORITY|Under the assumption of 0 difference in mean PRU between groups and a common standard deviation of 50 PRU, a sample size of 22 patients per group would allow for the 95%CI to stay within ± 45 PRU with a 90% power and alpha=0.05. In line with previously reported investigations, 45 PRU was chosen for the noninferiority margin for the upper 95%CI limit of the difference.|Mean Difference (Final Values)|130.0|||||TWO_SIDED|95.0|85.0|176.0||p-value was not calculated for noninferiority analysis|ANCOVA|||The primary hypothesis of our study was that in patients receiving concomitant administration of cangrelor and prasugrel (experimental arm), platelet inhibition as assessed by PRU would be noninferior to patients receiving prasugrel only (active control)||176|85|
73954632|NCT00916006|147444186|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
73954633|NCT00916006|147444187|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
73954634|NCT03643965|147444243|OTHER|Ratio of UPCR at 9 months compared to baseline for Nefecon compared to Placebo|Ratio of geometric LS means|0.73||||0.0003|TWO_SIDED|96.0|0.61|0.88|||MMRM model|||||0.88|0.61|0.0003
73954635|NCT03643965|147444244|OTHER|Time-weighted average of eGFR, Nefecon compared to Placebo|Ratio of geometric LS means|1.1|||<|0.0001|TWO_SIDED|95.0|1.06|1.15|||robust regression|||||1.15|1.06|<0.0001
73954636|NCT03643965|147444245|OTHER|Ratio of eGFR at 9 months comparison of Nefecon to Placebo|Ratio of geometric LS means|1.07||||0.0014|TWO_SIDED|95.0|1.03|1.13|||robust regression|||||1.13|1.03|0.0014
73954637|NCT03643965|147444246|OTHER|Ratio of eGFR at 12 months comparison of Nefecon to Placebo|Ratio of geometric LS means|1.07||||0.0106|TWO_SIDED|95.0|1.01|1.13|||robust regression|||||1.13|1.01|0.0106
73954638|NCT03643965|147444247|OTHER|Ratio of UACR at 9 months comparison of Nefecon to Placebo|Ratio of geometric LS means|0.69||||0.0005|TWO_SIDED|95.0|0.55|0.86|||MMRM model|||||0.86|0.55|0.0005
73954639|NCT03643965|147444248|OTHER|Time to 30% reduction in eGFR comparison Nefecon to Placebo|Hazard Ratio (HR)|0.45||||0.0028|TWO_SIDED|95.0|0.26|0.75|||Cox proportional hazards model|Cox proportional hazards model with individual patient censoring weighting.||||0.75|0.26|0.0028
73954640|NCT03643965|147444249|OTHER|Time to receiving rescue medication comparison Nefecon to Placebo|Hazard Ratio (HR)|0.68||||0.2647|TWO_SIDED|95.0|0.34|1.33|||Cox proportional hazards model|||||1.33|0.34|0.2647
73954641|NCT03643965|147444250|OTHER|Ratio of UPCR compared to baseline averaged over time points between 12 and 24 months, comparison Nefecon vs Placebo|Ratio of geometric LS means|0.59|||<|0.0001|TWO_SIDED|95.0|0.51|0.68|||MMRM model|||||0.68|0.51|<0.0001
73954642|NCT03643965|147444251|OTHER|Ratio of UACR compared to baseline averaged over time points between 12 and 24 months, Nefecon vs Placebo|Ratio of geometric LS means|0.54|||<|0.0001|TWO_SIDED|95.0|0.45|0.63|||MMRM model|||||0.63|0.45|<0.0001
73954643|NCT03643965|147444252|OTHER|Ratio of eGFR compared to baseline averaged over time points between 12 and 24 months, comparison Nefecon vs Placebo|Ratio of geometric LS means|1.11|||<|0.0001|TWO_SIDED|95.0|1.06|1.16|||robust regression|||||1.16|1.06|<0.0001
73954644|NCT03643965|147444253|OTHER|Proportion of patients without microhematuria, comparison Nefecon vs Placebo|Odds Ratio (OR)|2.5||||0.0001|TWO_SIDED|95.0|1.6|4.1|||Regression, Logistic|||||4.1|1.6|0.0001
73954645|NCT04956692|147444292|NON_INFERIORITY|The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8|Geometric Mean Ratio (GMR)|1.04|||<|0.0001|TWO_SIDED|96.0|0.98|1.1||The one-sided p-value non-inferiority boundary is 0.02|t-test, 1 sided|Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.|Numerator Arm A/Denominator Arm B|||1.10|0.98|<0.0001
73954646|NCT04956692|147444293|NON_INFERIORITY|The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8|Geometric Mean Ratio (GMR)|1.85|||<|0.0001|TWO_SIDED|94.0|1.69|2.03||The one-sided p-value non-inferiority boundary is 0.03|t-test, 1 sided|Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.|Numerator Arm A/Denominator Arm B|||2.03|1.69|<0.0001
73954647|NCT04863898|147444315|SUPERIORITY||Mean Difference (Net)|-6.1|||||TWO_SIDED|95.0|-7.0|-5.2|||||LME regression, random intercepts by individual and fixed effects of participant characteristics. Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||-5.2|-7|
73954648|NCT04863898|147444319|SUPERIORITY||Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.86|1.09|||||Calculated using a linear mixed effect regression model with random intercepts by individual Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||1.09|0.86|
73954649|NCT04863898|147444320|SUPERIORITY||Mean Difference (Net)|-4.2|||||TWO_SIDED|95.0|-4.7|-3.6|||||LME regression, random intercepts by individual and fixed effects of participant characteristics. Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||-3.6|-4.7|
73954650|NCT00614744|147444321|SUPERIORITY|This trial estimated the probability that the intervention has no effect on the outcome (or conversely, the probability that it does), given the data obtained in the trial and any prior evidence.|Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.59|1.29|||Bayesian log binomial models|Bayesian log binomial models were used to analyze the primary outcome of death or moderate/severe disability.|In log binomial models used Normal (0, sd=0.35) neutral prior in the log RR scale. Estimation used Normal weakly informative priors. Reported posterior medians \& 95% credible intervals for the RR above instead of confidence intervals.|Whole-body Hypothermia vs. Normothermia (Normothermia is the comparison group)|"We fitted all Bayesian models via Markov chain Monte Carlo methods (MCMC) using JAGS (version 3.4) and OpenBUGS (3.2.3) in R (version 3.2.5). For each analysis we ran 3 MCMC chains with starting values randomly drawn from the estimated parameters from a frequentist log binomial model. A burn-in of 1,000 iterations was used, with sampling from a further 10,000 iterations for each chain. To monitor convergence, trace plots and the Gelman-Rubin convergence diagnostic (Rhat) were used for all parameters.~For all analyses, the trace plots show good mixing of the 3 chains with Rhat \< 1.01 for all parameters, indicating convergence."|1.29|0.59|
73954651|NCT00770211|147444343|SUPERIORITY_OR_OTHER||Difference response rate|0.48|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.4|0.56|||Fisher Exact|||The efficacy of the treatment was confirmed, if H0 was rejected at a given alpha of 5%, that means if the two sided p-value is ≤ 0.05. Power of 90%||0.56|0.40|<0.0001
73954652|NCT03005288|147444350|SUPERIORITY||Mean Difference (Net)|-7.31|||<|0.001|TWO_SIDED|80.0|-8.48|-6.14|||Mixed-Effect Model Repeated Measure|||||-6.14|-8.48|<0.001
73954653|NCT03005288|147444351|SUPERIORITY||Mean Difference (Net)|-5.19|||<|0.001|TWO_SIDED|80.0|-6.01|-4.37|||Mixed-Effect Model Repeated Measure|||||-4.37|-6.01|<0.001
73954654|NCT03005288|147444352|SUPERIORITY||Mean Difference (Net)|-1.13|||<|0.001|TWO_SIDED|80.0|-1.42|-0.83|||Mixed Models Analysis|||week 24||-0.83|-1.42|<0.001
73954655|NCT03005288|147444352|SUPERIORITY||Mean Difference (Net)|-0.8||||0.005|TWO_SIDED|80.0|-1.2|-0.41|||Mixed Models Analysis|||week 48||-0.41|-1.20|0.005
73954656|NCT03005288|147444356|SUPERIORITY||Mean Difference (Net)|-1.33|||<|0.001|TWO_SIDED|80.0|-1.71|-0.95|||Mixed-Effect Model Repeated Measure|||week 24||-0.95|-1.71|<0.001
73954657|NCT03005288|147444356|SUPERIORITY||Mean Difference (Net)|-1.91|||<|0.001|TWO_SIDED|80.0|-2.48|-1.34|||Mixed-Effect Model Repeated Measure|||week 48||-1.34|-2.48|<0.001
73954658|NCT03005288|147444357|SUPERIORITY||Mean Difference (Net)|-3.43|||<|0.001|TWO_SIDED|80.0|-4.54|-2.31|||Mixed-Effect Model Repeated Measure|||week 24||-2.31|-4.54|<0.001
73954659|NCT03005288|147444357|SUPERIORITY||Mean Difference (Net)|-5.1|||<|0.001|TWO_SIDED|80.0|-6.74|-3.47|||Mixed-Effect Model Repeated Measure|||week 48||-3.47|-6.74|<0.001
73954660|NCT03005288|147444358|SUPERIORITY||Mean Difference (Net)|1.49||||0.003|TWO_SIDED|80.0|0.82|2.06|||Mixed-Effect Model Repeated Measure|||week 24||2.06|0.82|0.003
73954661|NCT03005288|147444358|SUPERIORITY||Mean Difference (Net)|2.14|||<|0.001|TWO_SIDED|80.0|1.36|2.93|||Mixed-Effect Model Repeated Measure|||week 48||2.93|1.36|<0.001
73954662|NCT03005288|147444359|SUPERIORITY||Mean Difference (Net)|-4.09|||<|0.001|TWO_SIDED|80.0|-5.26|-2.92|||Mixed-Effect Model Repeated Measure|||week 24||-2.92|-5.26|<0.001
73954663|NCT03005288|147444359|SUPERIORITY||Mean Difference (Net)|-9.46|||<|0.001|TWO_SIDED|80.0|-11.3|-7.64|||Mixed-Effect Model Repeated Measure|||week 52||-7.64|-11.3|<0.001
73954664|NCT03005288|147444360|SUPERIORITY||Mean Difference (Net)|-0.02||||0.062|TWO_SIDED|80.0|-0.03|0.0|||Mixed-Effect Model Repeated Measure|||week 24||-0.00|-0.03|0.062
73954665|NCT03005288|147444360|SUPERIORITY||Mean Difference (Net)|-0.06|||<|0.001|TWO_SIDED|80.0|-0.08|-0.04|||Mixed-Effect Model Repeated Measure|||week 52||-0.04|-0.08|<0.001
73954666|NCT03005288|147444361|SUPERIORITY||Mean Difference (Net)|-0.65||||0.028|TWO_SIDED|80.0|-1.03|-0.28|||Mixed-Effect Model Repeated Measure|||week 12||-0.28|-1.03|0.028
73954667|NCT03005288|147444361|SUPERIORITY||Mean Difference (Net)|-0.66||||0.081|TWO_SIDED|80.0|-1.14|-0.18|||Mixed-Effect Model Repeated Measure|||week 36||-0.18|-1.14|0.081
73954668|NCT00665561|147444363|SUPERIORITY||Risk Ratio (RR)|0.53|||||TWO_SIDED|95.0|0.42|0.67||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude risk ratio (RR) and CI.||0.67|0.42|
73954669|NCT00665561|147444364|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.12|5.88||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||5.88|0.12|
73954670|NCT00665561|147444365|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.66|1.33||||||All Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.33|0.66|
73954671|NCT00665561|147444365|SUPERIORITY||Risk Ratio (RR)|0.62|||||TWO_SIDED|95.0|0.29|1.31||||||AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.31|0.29|
73954672|NCT00665561|147444365|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.71|1.58||||||Non-AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.58|0.71|
73954673|NCT00665561|147444366|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.44|2.18||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||2.18|0.44|
73954674|NCT00665561|147444367|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.51|1.59||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.59|0.51|
73954675|NCT00665561|147444368|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.7|1.76||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.76|0.70|
73954676|NCT00665561|147444369|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.25|4.93||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||4.93|0.25|
73954677|NCT00665561|147444370|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.18|2.47||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||2.47|0.18|
73954678|NCT00665561|147444371|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.57|1.08||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.08|0.57|
73954679|NCT00665561|147444372|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.61|0.99||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||0.99|0.61|
73954680|NCT00665561|147444373|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.64|1.33||||||All malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.33|0.64|
73954681|NCT00665561|147444373|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.32|1.52||||||AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.32|
73954682|NCT00665561|147444373|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||Non-AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.66|
73954683|NCT00665561|147444374|SUPERIORITY||Risk Ratio (RR)|0.62|||||TWO_SIDED|95.0|0.35|1.1||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.10|0.35|
73954684|NCT00665561|147444375|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.59|1.52||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.59|
73954685|NCT00665561|147444376|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.66|1.28||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.28|0.66|
73954686|NCT00665561|147444377|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6225|TWO_SIDED|95.0|0.66|1.28|||Regression, Cox|||||1.28|0.66|0.6225
73954687|NCT03824236|147444378|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people (P-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|52.0||||0.003|TWO_SIDED|95.0|28.0|68.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between P-Fx group and the Infectivity Control group.||68|28|0.003
73954688|NCT03824236|147444378|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people (NP-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|54.0||||0.002|TWO_SIDED|95.0|29.0|70.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between NP-Fx group and the Infectivity Control group.||70|29|0.002
73954689|NCT01140347|147444400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.866||||0.1391|TWO_SIDED|95.0|0.717|1.046|||Log Rank||HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the Interactive Web Response System (IWRS) stratification factors (geographical regions and etiology of liver disease).|||1.046|0.717|0.1391
73954690|NCT01140347|147444401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.625|||<|0.0001|TWO_SIDED|95.0|0.522|0.75|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).|||0.750|0.522|<0.0001
73954691|NCT01140347|147444402|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for geographic region and etiology liver disease||||||<0.0001
73954692|NCT01140347|147444403|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.593|||<|0.0001|TWO_SIDED|95.0|0.487|0.722|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).|||0.722|0.487|<0.0001
73954693|NCT01449929|147444413|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTG 50 mg and DRV+RTV at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - DRV+RTV) is greater than -12%. If non-inferiority is established, superiority can be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.1||||0.025|TWO_SIDED|95.0|0.9|13.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Stratified analysis|Analysis was adjusted for the Baseline (BL) stratification factors: Baseline plasma HIV-1 RNA (\<=100,000 c/mL vs \>100,000 c/mL) and Baseline background dual NRTI therapy (ABC/3TC vs TDF/FTC).|||13.2|0.9|0.025
73954694|NCT01871285|147444432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.7942|TWO_SIDED|95.0|-1.6|1.24|||Mixed Models Analysis|||||1.24|-1.60|.7942
73954695|NCT01871285|147444432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.683||||0.6155|TWO_SIDED|95.0|-11.89|13.25|||Mixed Models Analysis|||||13.25|-11.89|.6155
73954696|NCT01871285|147444433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.7942|TWO_SIDED|95.0|-1.6|1.24|||Mixed Models Analysis|||||1.24|-1.60|.7942
73981524|NCT02978716|147508180|SUPERIORITY||Adjusted rate ratio|0.885|STANDARD_ERROR_OF_MEAN|0.3089||0.7272|TWO_SIDED|95.0|0.447|1.754||P-value was calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as the stratification factors and baseline hemoglobin as a covariate.|Modified Poisson Regression|||RBC Transfusions in Group 2 vs Group 1.||1.754|0.447|0.7272
73981525|NCT02978716|147508181|SUPERIORITY||Adjusted rate ratio|0.988|STANDARD_ERROR_OF_MEAN|0.6105||0.7048|TWO_SIDED|95.0|0.294|3.317||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||Platelet Transfusions in Group 3 vs Group 1.||3.317|0.294|0.7048
73981526|NCT02978716|147508181|SUPERIORITY||Adjusted rate ratio|0.527|STANDARD_ERROR_OF_MEAN|0.4077||0.4078|TWO_SIDED|95.0|0.116|2.399||P-value: calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as stratification factors and baseline platelet count as a covariate.|Modified Poisson Regression|||Platelet Transfusions in Group 2 vs Group 1.||2.399|0.116|0.4078
73981527|NCT02978716|147508182|SUPERIORITY||Adjusted rate ratio|0.645|STANDARD_ERROR_OF_MEAN|0.1902||0.7048|TWO_SIDED|95.0|0.362|1.15||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||G-CSF Administration in Group 3 vs Group 1.||1.150|0.362|0.7048
73981528|NCT02978716|147508182|SUPERIORITY||Adjusted rate ratio|0.936|STANDARD_ERROR_OF_MEAN|0.226||0.7835|TWO_SIDED|95.0|0.583|1.502||P-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.|Modified Poisson Regression|||G-CSF Administration in Group 2 vs Group 1.||1.502|0.583|0.7835
73981529|NCT02978716|147508185|SUPERIORITY||Adjusted rate ratio|0.991|STANDARD_ERROR_OF_MEAN|0.3718||0.7048|TWO_SIDED|95.0|0.475|2.067||The 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global family wise error rate across the multiple null hypotheses.|negative binomial regression|||All-cause Dose Reductions in Group 3 vs Group 1.||2.067|0.475|0.7048
73981530|NCT02978716|147508185|SUPERIORITY||Adjusted rate ratio|0.82|STANDARD_ERROR_OF_MEAN|0.2744||0.5541|TWO_SIDED|95.0|0.426|1.58||P-value was calculated using negative binomial method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|negative binomial regression|||All-cause Dose Reductions in Group 2 vs Group 1.||1.580|0.426|0.5541
73981531|NCT00960206|147508191|SUPERIORITY_OR_OTHER|||||||0.0832|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems||||0.0832
73981532|NCT00960206|147508191|SUPERIORITY_OR_OTHER|||||||0.1657|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems||||0.1657
73981533|NCT00960206|147508192|SUPERIORITY_OR_OTHER|||||||0.3701|||||||Fisher Exact|||To compare the # of cases at 10 years for those that have a HHS ≥ 80 to those that have \< 80 for all three arms||||0.3701
73981534|NCT00960206|147508194|SUPERIORITY_OR_OTHER|||||||0.6011|||||||Fisher Exact|||Compare the # of cases at 10 years satisfied with their total hip replacement for all three groups||||0.6011
73981535|NCT00960206|147508194|SUPERIORITY_OR_OTHER|||||||0.206|||||||Fisher Exact|||Compare the # of cases at 10 years for having pain in their hip for all three groups||||0.2060
73981536|NCT02470806|147508199|NON_INFERIORITY|Stepwise regression method - Primary efficacy analysis, difference between treatment groups in percentage change in wound area from baseline visit to end of 12-week treatment period for the PP population.||||||0.001|TWO_SIDED|95.0|||||Stepwise regression|||Percentage change in wound area from Baseline to end of 12-week treatment period (PP population - all wounds)||||0.001
73981537|NCT00091572|147508250|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2663||95.0|0.8|1.06|||Log Rank||Temozolomide events (progressions/deaths) = 401. Dacarbazine events (progressions/deaths) = 398.|||1.06|0.80|0.2663
73954697|NCT01871285|147444433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.683||||0.6155|TWO_SIDED|95.0|-11.89|13.25|||Mixed Models Analysis|||||13.25|-11.89|.6155
73954698|NCT00662909|147444445|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34||||0.026|TWO_SIDED|95.0|-0.66|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.03|-0.66|0.026
73981538|NCT00091572|147508251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9999||95.0|0.86|1.17|||Log Rank||Temozolomide events (deaths) = 320. Dacarbazine events (deaths) = 325.|||1.17|0.86|0.9999
73981539|NCT00091572|147508252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.0718||95.0|0.97|2.12|||Cochran-Mantel-Haenszel||Temozolomide numerator (responders) = 55. Dacarbazine numerator (responders) = 37.|||2.12|0.97|0.0718
74033524|NCT00905307|147619882|SUPERIORITY_OR_OTHER||Treatment difference|-1.24||||0.1764|TWO_SIDED|95.0|-3.05|0.56|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.56|-3.05|0.1764
73954699|NCT00662909|147444445|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.82|-0.18||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.18|-0.82|<0.001
73954700|NCT00662909|147444446|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61||||0.001|TWO_SIDED|95.0|-0.98|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.24|-0.98|0.001
73954701|NCT00662909|147444446|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-1.07|-0.33||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.33|-1.07|<0.001
73954702|NCT00662909|147444447|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.1||||0.001|TWO_SIDED|95.0|4.4|17.9||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.9|4.4|0.001
74033525|NCT00905307|147619882|SUPERIORITY_OR_OTHER||Treatment difference|-1.79||||0.1111|TWO_SIDED|95.0|-4.0|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.42|-4.00|0.1111
74033526|NCT00905307|147619883|SUPERIORITY_OR_OTHER||Treatment difference|1.0||||0.2896|TWO_SIDED|95.0|-0.86|2.86|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||2.86|-0.86|0.2896
74033527|NCT00905307|147619883|SUPERIORITY_OR_OTHER||Treatment difference|-0.61||||0.3701|TWO_SIDED|95.0|-1.94|0.72|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.72|-1.94|0.3701
73954703|NCT00662909|147444447|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.0||||0.002|TWO_SIDED|95.0|4.2|17.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.7|4.2|0.002
73954704|NCT00662909|147444448|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48||||0.003|TWO_SIDED|95.0|-0.8|-0.15||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.15|-0.80|0.003
74089604|NCT02791893|147731973|SUPERIORITY||Mean Difference (Final Values)|-5.71||||0.58|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention headache days was regressed on pre-intervention headache days and condition, using an ANCOVA model.||||0.58
73954705|NCT00662909|147444448|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.79|-0.13||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.13|-0.79|<0.001
73954706|NCT00662909|147444449|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.022|TWO_SIDED|95.0|-0.77|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.06|-0.77|0.022
73954707|NCT00662909|147444449|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.001|TWO_SIDED|95.0|-0.96|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.24|-0.96|0.001
73954708|NCT03371108|147444484|EQUIVALENCE|The determination of equivalence was defined by the US-FDA as a confidence interval that was contained within the equivalence limits of +/- 10.7.|Risk Difference (RD)|-2.1|STANDARD_ERROR_OF_MEAN|3.39|||TWO_SIDED|90.0|-7.6|3.5|||||The asymptotic standard error was planned and is reported above.|This is a two-arm study.||3.5|-7.6|
73981540|NCT01159600|147508308|SUPERIORITY_OR_OTHER||Mean difference|-1.63|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.17|-1.08||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.08|-2.17|<0.0001
73954709|NCT02790606|147444499|SUPERIORITY|||||||0.0021|||||||Exact binomial test|||"The primary safety endpoint is evaluated against a PG of 88%, which was derived from safety event rates of PTA in published literature.~Hypothesis: The safety rate in subjects treated with the COVERA™ Vascular Covered Stent (following PTA) at 30 days post-index procedure is greater than that of the PG of 88%. 109 treated subjects \[104 evaluable\] will give 99% power with one-sided type I error = 0.05."||||0.0021
73954710|NCT02790606|147444500|SUPERIORITY||||||<|0.0001||||||The p-value is compared to the PG (40%) and computed using the exact binomial test.|Exact binomial test|||"The primary effectiveness endpoint is evaluated against a PG of 40%, which was derived from clinical literature as well as other pivotal and post-market studies of stent grafts at the graft-vein anastomosis of AV access patients dialyzing with an AV graft. 89% estimated power for primary endpoint.~Hypothesis: The proportion of subjects treated with the COVERA™ Vascular Covered Stent (following PTA) with respect to TLPP through 6 months post-index procedure is greater than that of the PG of 40%."||||<0.0001
73954711|NCT01764386|147444543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.52|||<|0.0001|TWO_SIDED|95.0|-9.88|-7.15|||ANCOVA|||||-7.15|-9.88|<0.0001
73873832|NCT00596752|147289473|SUPERIORITY_OR_OTHER|||||||0.2587||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing. The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."||||0.2587
73981541|NCT01159600|147508308|SUPERIORITY_OR_OTHER||Mean difference|-2.01|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.56|-1.46||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.46|-2.56|<0.0001
73981542|NCT01159600|147508308|SUPERIORITY_OR_OTHER||Mean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|97.5|-2.25|-1.28||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.28|-2.25|<0.0001
73981543|NCT01159600|147508308|SUPERIORITY_OR_OTHER||Mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|97.5|-2.48|-1.5||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.50|-2.48|<0.0001
73981544|NCT01159600|147508309|SUPERIORITY_OR_OTHER||Mean difference|-7.65|STANDARD_ERROR_OF_MEAN|2.74||0.0055|TWO_SIDED|97.5|-13.81|-1.48||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-1.48|-13.81|0.0055
74033528|NCT00905307|147619883|SUPERIORITY_OR_OTHER||Treatment difference|-0.35||||0.6074|TWO_SIDED|95.0|-1.69|0.99|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.99|-1.69|0.6074
74039500|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.0135|TWO_SIDED|95.0|-0.24|-0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.24|0.0135
73954712|NCT01764386|147444544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.0|||<|0.0001|TWO_SIDED|95.0|16.6|116.3|||Regression, Logistic|||||116.3|16.6|<0.0001
73954713|NCT01764386|147444545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.4|||<|0.0001|TWO_SIDED|95.0|6.0|76.7|||Regression, Logistic|||||76.7|6.0|<0.0001
73954714|NCT01764386|147444547|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.65|||<|0.0001|TWO_SIDED|95.0|-10.07|-7.24|||ANCOVA|||||-7.24|-10.07|<0.0001
73954715|NCT01764386|147444548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.32|||<|0.0001|TWO_SIDED|95.0|-7.14|-3.5|||ANCOVA|||||-3.50|-7.14|<0.0001
73954716|NCT01764386|147444549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.4||||0.0019|TWO_SIDED|95.0|-29.5|-3.3|||ANCOVA|||||-3.3|-29.5|0.0019
73954717|NCT01764386|147444550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.9686|TWO_SIDED|95.0|-5.96|5.73|||ANCOVA|||||5.73|-5.96|0.9686
73954718|NCT01764386|147444551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.0001|TWO_SIDED|95.0|1.99|6.06|||ANCOVA|||||6.06|1.99|0.0001
73954719|NCT01764386|147444552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.1706|TWO_SIDED|95.0|-4.9|0.9|||ANCOVA|||||0.9|-4.9|0.1706
73954720|NCT01764386|147444553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.716|TWO_SIDED|95.0|-2.6|1.8|||ANCOVA|||||1.8|-2.6|0.7160
73954721|NCT01764386|147444554|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0||||0.0913|TWO_SIDED|95.0|-0.3|4.3|||ANCOVA|||||4.3|-0.3|0.0913
73954722|NCT01764386|147444555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5||||0.0016|TWO_SIDED|95.0|-7.2|-1.7|||ANCOVA|||||-1.7|-7.2|0.0016
74033529|NCT00905307|147619883|SUPERIORITY_OR_OTHER||Treatment difference|-0.73||||0.2777|TWO_SIDED|95.0|-2.05|0.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.59|-2.05|0.2777
73954723|NCT01764386|147444556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.0004|TWO_SIDED|95.0|-6.2|-2.0|||ANCOVA|||||-2.0|-6.2|0.0004
73954724|NCT01764386|147444557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.0003|TWO_SIDED|95.0|-1.7|-0.7|||ANCOVA|||||-0.7|-1.7|0.0003
73954725|NCT01764386|147444558|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.9|||<|0.0001|TWO_SIDED|95.0|-9.8|-6.0|||ANCOVA|||||-6.0|-9.8|<0.0001
73954726|NCT01764386|147444559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.1|||ANCOVA|||||-1.1|-3.1|<0.0001
73954727|NCT01764386|147444560|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.4|||<|0.0001|TWO_SIDED|95.0|13.45|21.36|||ANCOVA|||||21.36|13.45|<0.0001
73954728|NCT03929302|147444563|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
73954729|NCT03929302|147444563|SUPERIORITY||Mean Difference (Final Values)|1.57||||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
73954730|NCT03929302|147444563|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.642|TWO_SIDED||||||Regression, Linear|||||||0.642
73954731|NCT00886613|147444578|SUPERIORITY_OR_OTHER||kappa coefficient of agreement|0.85||||0.564|TWO_SIDED|90.0|0.72|0.99|||McNemar||The significance of the difference between the proportion of subjects with a positive skin test at 48 hours and the proportion of subjects with a positive skin test at 72 hours|||0.99|0.72|0.564
73954732|NCT00886613|147444580|SUPERIORITY_OR_OTHER||Difference in proportions|0.06||||0.343|TWO_SIDED|90.0|-0.17|0.28|||Chi-squared||Statistical analysis for dose 2|||0.28|-0.17|0.343
73954733|NCT01492309|147444596|SUPERIORITY|||||||0.003|||||||Fisher Exact|||This analysis is based on a mixed model that can handle missing data.||||0.003
73954734|NCT01492309|147444597|SUPERIORITY|||||||0.425|||||||Regression, Logistic|||This analysis is based on a mixed model that can handle missing data.||||0.425
73954735|NCT03613129|147444624|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.011|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.011
73954736|NCT03613129|147444624|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.136|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.136
73954737|NCT03613129|147444624|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.009|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.009
73954738|NCT03613129|147444624|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.451|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.451
73954739|NCT03613129|147444624|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.24|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.240
73954740|NCT03613129|147444625|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.039|||||||t-test, 2 sided|||||||0.039
73954741|NCT03613129|147444625|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.191|||||||t-test, 2 sided|||||||0.191
73954742|NCT03613129|147444625|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.016|||||||t-test, 2 sided|||||||0.016
73954743|NCT03613129|147444625|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.053|||||||t-test, 2 sided|||||||0.053
73954744|NCT03613129|147444625|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.06|||||||t-test, 2 sided|||||||0.060
73954745|NCT03613129|147444626|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.587|||||||t-test, 2 sided|||||||0.587
73954746|NCT03613129|147444626|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.618|||||||t-test, 2 sided|||||||0.618
73954747|NCT03613129|147444626|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.634|||||||t-test, 2 sided|||||||0.634
73954748|NCT03613129|147444626|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.355|||||||t-test, 2 sided|||||||0.355
73954749|NCT03613129|147444626|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.417|||||||t-test, 2 sided|||||||0.417
73954750|NCT02334306|147444627|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|1.3||0.262|TWO_SIDED|90.0|-3.6|0.7|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.|||0.7|-3.6|0.262
73954751|NCT02334306|147444628|SUPERIORITY||Mean Difference (Net)|0.93|STANDARD_ERROR_OF_MEAN|0.33||0.82|TWO_SIDED|90.0|0.52|1.64|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For plasma cell levels||1.64|0.52|0.820
73954752|NCT02334306|147444628|SUPERIORITY||Median Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.4||0.291|TWO_SIDED|90.0|0.33|1.28|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For TFH cells||1.28|0.33|0.291
73954753|NCT02334306|147444629|SUPERIORITY||Mean Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|0.17||0.44|TWO_SIDED|90.0|0.65|1.18|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For total plasma cells||1.18|0.65|0.440
73954754|NCT02334306|147444629|SUPERIORITY||Median Difference (Net)|0.43|STANDARD_ERROR_OF_MEAN|0.28||0.008|TWO_SIDED|90.0|0.26|0.7|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For CD4/ICOS TFH cells||0.70|0.26|0.008
73954755|NCT02334306|147444629|SUPERIORITY||Median Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|0.26||0.972|TWO_SIDED|90.0|0.64|1.59|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For PD-1/ICOS TFH cells||1.59|0.64|0.972
74033530|NCT00905307|147619883|SUPERIORITY_OR_OTHER||Treatment difference|-0.15||||0.8611|TWO_SIDED|95.0|-1.9|1.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.59|-1.90|0.8611
73954756|NCT02334306|147444631|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.7||0.574|TWO_SIDED|90.0|-0.8|1.6|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.|||1.6|-0.8|0.574
73954757|NCT02334306|147444632|SUPERIORITY||Difference in percentages|25.0||||0.252|TWO_SIDED|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI \[3\]||50.9|-3.1|0.252
73954758|NCT02334306|147444632|SUPERIORITY||Difference in precentages|25.0||||0.252|TWO_SIDED|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI\[4\]||50.9|-3.1|0.252
73954759|NCT02390557|147444651|SUPERIORITY||Mean Difference (Final Values)|10.7||||0.074|TWO_SIDED||||||Chi-squared, Corrected|||we had a prior hypothesis that the survey intervention would be associated with a larger increase in perceived quality of health care compared with control from Wave 1 to Wave 2||||0.074
73954760|NCT02390557|147444651|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.069|TWO_SIDED||||||Chi-squared, Corrected|||We compared change in perception of quality of health care between Control v YES Health, wave 1 v Wave 2||||.069
73954761|NCT00293462|147444663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0|||||Fisher Exact|Two by two table was used. One cell had expected frequency test less than five, so Fisher's exact two-tailed test was used.||Fisher's exact two tailed test||||0.09
73954762|NCT00293462|147444664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|TWO_SIDED|95.0|||||Mantel Haenszel|Log rank, Breslow, Tarone-Ware test, but used mantel cox log rank for this analysis||Kaplan-Meier estimate of the survival curves used information from subjects who develop mucositis to the healing of the mucositis in three groups, Group GG, SS, and SG. In order to compare the three curves that were created, the Mantel-Haenszel log-rank statistic was used||||0.92
73954763|NCT00293462|147444665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0||||0.28 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||Multilevel regression was used.||||0.28
73954764|NCT00293462|147444666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0||||0.78 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||||||0.78
73981545|NCT01159600|147508309|SUPERIORITY_OR_OTHER||Mean difference|-12.37|STANDARD_ERROR_OF_MEAN|2.75|<|0.0001|TWO_SIDED|97.5|-18.55|-6.19||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-6.19|-18.55|<0.0001
74033531|NCT00905307|147619884|SUPERIORITY_OR_OTHER||Treatment difference|-2.36||||0.3726|TWO_SIDED|95.0|-7.57|2.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||2.85|-7.57|0.3726
74033532|NCT00905307|147619884|SUPERIORITY_OR_OTHER||Treatment difference|3.8||||0.0664|TWO_SIDED|95.0|-0.26|7.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||7.85|-0.26|0.0664
74033533|NCT00905307|147619884|SUPERIORITY_OR_OTHER||Treatment difference|2.2||||0.2944|TWO_SIDED|95.0|-1.92|6.32|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||6.32|-1.92|0.2944
73954765|NCT00293462|147444667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||0.22 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||||||0.22
73954766|NCT01950260|147444696|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
73954767|NCT01950260|147444697|SUPERIORITY|||||||0.41|||||||Regression, Linear|||||||0.41
73954768|NCT01950260|147444698|SUPERIORITY|||||||0.33|||||||Regression, Linear|||||||0.33
73954769|NCT03283553|147444699|SUPERIORITY|||||||0.264||||||P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.264
73954770|NCT03283553|147444700|SUPERIORITY|||||||0.555||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.555
73954771|NCT03283553|147444701|SUPERIORITY|||||||0.619||||||P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.619
73954772|NCT03283553|147444702|SUPERIORITY|||||||0.532||||||P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.532
73954773|NCT03283553|147444703|SUPERIORITY|||||||0.108||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.108
73954774|NCT03283553|147444704|SUPERIORITY|||||||0.405||||||P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.405
73954775|NCT03283553|147444705|SUPERIORITY|||||||0.412||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.412
73954776|NCT03283553|147444706|SUPERIORITY|||||||0.872||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.872
73954777|NCT03283553|147444707|SUPERIORITY||||||<|0.001|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who were registered during the 9-month follow up period.||||||<0.001
73954778|NCT03283553|147444708|SUPERIORITY|||||||0.003|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.||||||0.003
73954779|NCT03283553|147444709|SUPERIORITY||||||<|0.001|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.||||||<0.001
73954780|NCT03283553|147444710|SUPERIORITY|||||||0.128||||||P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.|Fisher Exact|||||||0.128
73954781|NCT03283553|147444711|SUPERIORITY|||||||0.247||||||P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.|Fisher Exact|||||||0.247
73954782|NCT03686683|147444712|SUPERIORITY||Odds Ratio (OR)|1.16||||0.4586|TWO_SIDED|95.0|0.78|1.74|||Cochran-Mantel-Haenszel|||||1.74|0.78|0.4586
73954783|NCT00372060|147444717|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0|-1.0|-0.6|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline HbA1c.||||-0.6|-1.0|<0.001
73954784|NCT00372060|147444718|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|3.39|<|0.001||95.0|-23.4|-10.0|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline fasting plasma glucose.||||-10.0|-23.4|<0.001
73954785|NCT00372060|147444719|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-49.2|STANDARD_ERROR_OF_MEAN|7.7|<|0.001||95.0|-64.5|-33.9|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline 2-hour postprandial glucose.||||-33.9|-64.5|<0.001
73954786|NCT01579578|147444721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|12.23||0.688|TWO_SIDED|95.0|-30.81|20.81||two sided p value|ANCOVA|ANCOVA model including covariates for baseline tumour size, for the time from the baseline scan to randomisation and with a term for HER2 status.|the difference in LS means is estimated|60 patients had been considered to detect a -20% difference in the estimated average percentage change in tumour size at 8 weeks for AZD8931 plus paclitaxel compared to paclitaxel alone at a one-sided significance level of 10% with 90% power. This is based on a standard deviation of 30% for tumour data (on an absolute scale)||20.81|-30.81|0.688
73954787|NCT02987829|147444739|OTHER|||||||||||||||||Determination of the maximum tolerated dose.|One dose limiting toxicity occurred at 320 mg daily of grade 3 QTc prolongation therefore the 280 mg dose was determined to be the maximum tolerated dose and selected as the phase 2 dose.|||
73954788|NCT00647348|147444745|OTHER|intention-to-treat analysis||||||0.003|||||||BBSI=brain boundary shift integral|||||||0.003
74033534|NCT00905307|147619884|SUPERIORITY_OR_OTHER||Treatment difference|3.86||||0.0596|TWO_SIDED|95.0|-0.16|7.89|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||7.89|-0.16|0.0596
74033535|NCT00905307|147619884|SUPERIORITY_OR_OTHER||Treatment difference|3.25||||0.1819|TWO_SIDED|95.0|-1.53|8.03|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||8.03|-1.53|0.1819
73873833|NCT00596752|147289473|SUPERIORITY_OR_OTHER|||||||0.3463||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing.~This is the statistical analysis of stage 1 and stage 2 combined."||||0.3463
73954789|NCT00647348|147444746|SUPERIORITY|||||||0.05||||||EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.|ANCOVA|EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.||||||0.05
73954790|NCT00714233|147444755|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Paired t-test to analyze BMI at baseline and 24 weeks||||<0.05
73954791|NCT04889118|147444779|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.55||||0.0013|TWO_SIDED|95.0|0.37|0.81||One-sided p-value based on log-rank test.|Log Rank||HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||0.81|0.37|0.0013
73954792|NCT04889118|147444780|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|Hazard Ratio (HR)|0.93||||0.3728|TWO_SIDED|95.0|0.58|1.48||One-sided p-value based on log-rank test|Log Rank||HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.48|0.58|0.3728
73954793|NCT01454362|147444823|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
73954794|NCT01454362|147444824|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
73954795|NCT01454362|147444825|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73954796|NCT01454362|147444826|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73981546|NCT01159600|147508309|SUPERIORITY_OR_OTHER||Mean difference|-10.02|STANDARD_ERROR_OF_MEAN|2.53|<|0.0001|TWO_SIDED|97.5|-15.72|-4.32||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-4.32|-15.72|<0.0001
73954797|NCT01454362|147444827|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
73954798|NCT00797225|147444829|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.0464|TWO_SIDED|95.0|-0.98|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-0.98|0.0464
74033536|NCT00905307|147619885|SUPERIORITY_OR_OTHER||Treatment difference|0.38||||0.0685|TWO_SIDED|95.0|-0.03|0.79|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in CGI-S score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.79|-0.03|0.0685
73954799|NCT00797225|147444829|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.13|-0.17|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.17|-1.13|0.0080
73954800|NCT00797225|147444829|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.24||0.0159|TWO_SIDED|95.0|-1.08|-0.11|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.11|-1.08|0.0159
73954801|NCT00797225|147444829|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.29||0.2563|TWO_SIDED|95.0|-0.89|0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.24|-0.89|0.2563
73954802|NCT00797225|147444829|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.0239|TWO_SIDED|95.0|-1.21|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.09|-1.21|0.0239
73954803|NCT00797225|147444829|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.28||0.028|TWO_SIDED|95.0|-1.19|-0.07|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.07|-1.19|0.0280
74033537|NCT00905307|147619885|SUPERIORITY_OR_OTHER||Treatment difference|-0.28||||0.0989|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.05|-0.60|0.0989
74033538|NCT00905307|147619885|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.8006|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.28|-0.37|0.8006
74033539|NCT00905307|147619885|SUPERIORITY_OR_OTHER||Treatment difference|-0.28||||0.0898|TWO_SIDED|95.0|-0.6|0.04|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.04|-0.60|0.0898
74033540|NCT00905307|147619885|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.2851|TWO_SIDED|95.0|-0.59|0.18|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.18|-0.59|0.2851
74033541|NCT00905307|147619886|SUPERIORITY_OR_OTHER|||||||0.4008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||||0.4008
74033542|NCT00905307|147619886|SUPERIORITY_OR_OTHER|||||||0.1117|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||||0.1117
74089605|NCT02791893|147731973|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.49|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention headache days was regressed on pre-intervention headache days and condition, using an ANCOVA model.||||0.49
74089606|NCT02791893|147731974|SUPERIORITY||Mean Difference (Final Values)|-1.42||||0.18|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention depression scores were regressed on pre-intervention depression scores and condition, using an ANCOVA model.||||0.18
74033543|NCT00905307|147619886|SUPERIORITY_OR_OTHER|||||||0.2739|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.2739
74033544|NCT00905307|147619886|SUPERIORITY_OR_OTHER|||||||0.1045|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.1045
74033545|NCT00905307|147619886|SUPERIORITY_OR_OTHER|||||||0.1149|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.1149
74033546|NCT00905307|147619887|SUPERIORITY_OR_OTHER||Relative Risk|0.89||||0.62|TWO_SIDED|95.0|0.57|1.4|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.40|0.57|0.6200
74033547|NCT00905307|147619887|SUPERIORITY_OR_OTHER||Relative Risk|1.19||||0.1501|TWO_SIDED|95.0|0.95|1.48|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.48|0.95|0.1501
73873834|NCT00596752|147289474|SUPERIORITY_OR_OTHER|||||||0.0173||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."||||0.0173
73873835|NCT00596752|147289474|SUPERIORITY_OR_OTHER|||||||0.1154||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~This is the statistical analysis of stage 1 and stage 2 combined."||||0.1154
73873836|NCT02940496|147289493|SUPERIORITY||Correlation Coefficient (2 sided test)|0.081||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
73954804|NCT00797225|147444829|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.29||0.6904|TWO_SIDED|95.0|-0.7|0.46|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.46|-0.70|0.6904
73954805|NCT00797225|147444829|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.4022|TWO_SIDED|95.0|-0.83|0.33|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.33|-0.83|0.4022
73954806|NCT00797225|147444829|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.29||0.0451|TWO_SIDED|95.0|-1.17|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-1.17|0.0451
73954807|NCT00797225|147444830|SUPERIORITY||LS Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.48||0.0007|TWO_SIDED|95.0|-2.56|-0.69|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.69|-2.56|0.0007
73954808|NCT00797225|147444830|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.47||0.0006|TWO_SIDED|95.0|-2.56|-0.7|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.70|-2.56|0.0006
73954809|NCT00797225|147444830|SUPERIORITY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.47||0.0073|TWO_SIDED|95.0|-2.21|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.35|-2.21|0.0073
73954810|NCT00797225|147444830|SUPERIORITY||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.48||0.0054|TWO_SIDED|95.0|-2.28|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.40|-2.28|0.0054
73954811|NCT00797225|147444830|SUPERIORITY||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.01|-1.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.12|-3.01|< 0.0001
73873837|NCT02940496|147289494|SUPERIORITY||Correlation Coefficient (2-sided test)|0.88||||0.009|TWO_SIDED||||||t-test, 2 sided|||||||0.009
73954812|NCT00797225|147444830|SUPERIORITY||LS Mean Difference|-2.73|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.67|-1.79|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.79|-3.67|< 0.0001
73873838|NCT02940496|147289495|SUPERIORITY||Correlation Coefficient (2-sided test)|0.79||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
73873839|NCT01895946|147289496|SUPERIORITY_OR_OTHER||Least square mean difference (LSM)|1.02|||||TWO_SIDED|90.0|0.86|1.2|||Mixed Models Analysis|||||1.20|0.86|
73873840|NCT01895946|147289496|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.67|||||TWO_SIDED|90.0|0.55|0.82|||Mixed Models Analysis|||||0.82|0.55|
73873841|NCT01895946|147289497|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.9|||||TWO_SIDED|90.0|0.77|1.06|||Mixed Models Analysis|||||1.06|0.77|
73954813|NCT00797225|147444830|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.48||0.0509|TWO_SIDED|95.0|-1.89|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-1.89|0.0509
73954814|NCT00797225|147444830|SUPERIORITY||LS mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.48||0.0046|TWO_SIDED|95.0|-2.33|-0.43|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.43|-2.33|0.0046
73954815|NCT00797225|147444830|SUPERIORITY||LS Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.26|-1.38|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.38|-3.26|< 0.0001
73954816|NCT00797225|147444831|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0453|TWO_SIDED|95.0|-0.33|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-0.33|0.0453
73954817|NCT00797225|147444831|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0609|TWO_SIDED|95.0|-0.31|0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.01|-0.31|0.0609
73954818|NCT00797225|147444831|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.0069|TWO_SIDED|95.0|-0.38|-0.06|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.06|-0.38|0.0069
73954819|NCT00797225|147444831|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0556|TWO_SIDED|95.0|-0.32|0.0|||Mixed-effects Repeated Measures Model]|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-0.32|0.0556
73954820|NCT00797225|147444831|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.0387|TWO_SIDED|95.0|-0.33|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-0.33|0.0387
74033548|NCT00905307|147619887|SUPERIORITY_OR_OTHER||Relative Risk|0.91||||0.5271|TWO_SIDED|95.0|0.66|1.25|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.25|0.66|0.5271
74089607|NCT02791893|147731974|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.25|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention depression scores were regressed on pre-intervention depression scores and condition, using an ANCOVA model.||||0.25
74089608|NCT02791893|147731975|SUPERIORITY|||||||0.004||||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was a dependent t-test comparing pre-intervention scores to the scores collected at the end of the open label phase.||Regardless of original condition assignment, patients' 2.5-month pain scores at the end of the open label phase were compared to their baseline scores using a dependent samples t-test. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the open-label phase had their most recent score carried forward. All patients included in this comparison received at least 10 weeks of VNS therapy.||||0.004
74089609|NCT02791893|147731975|SUPERIORITY|||||||0.005||||||This was a dependent t-test comparing baseline scores to the scores collected at the end of the open label phase.|t-test, 2 sided|||Regardless of original condition assignment, patients' 2.5-month pain scores at the end of the open label phase were compared to their baseline scores using a dependent samples t-test. Below are the results of the per protocol analysis. Patients that did not complete the assessment after the open-label phase were excluded. All patients included in this comparison received at least 10 weeks of VNS therapy.||||0.005
73873842|NCT01895946|147289497|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.89|||||TWO_SIDED|90.0|0.76|1.05|||Mixed Models Analysis|||||1.05|0.76|
73873843|NCT03089541|147289507|SUPERIORITY||Odds Ratio (OR)|0.17||||0.002|TWO_SIDED|95.0|0.06|0.52|||Regression, Logistic|||Comparison on Eating/Drinking using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||0.52|0.06|0.002
73954821|NCT00797225|147444831|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08||0.0008|TWO_SIDED|95.0|-0.44|-0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.12|-0.44|0.0008
73873844|NCT03089541|147289507|SUPERIORITY||Odds Ratio (OR)|2.65||||0.07|TWO_SIDED|95.0|0.92|7.65|||Regression, Logistic|||Comparison on Traveling using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7)). The significance level was 0.05.||7.65|0.92|0.07
73954822|NCT00797225|147444831|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.5879|TWO_SIDED|95.0|-0.21|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.12|-0.21|0.5879
73954823|NCT00797225|147444831|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.6122|TWO_SIDED|95.0|-0.2|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.12|-0.20|0.6122
74009156|NCT00097773|147569073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.28||95.0|0.49|1.23|||Regression, Logistic|No interaction with ciprofloxacin usage was observed.|odds of a positive culture comparing cycled therapy to culture-based therapy|Null hypothesis is that there is no difference between pooled cycled and culture-based treatment groups in the odds of a Pa positive culture over the 18 month study.||1.23|0.49|0.28
74033549|NCT00905307|147619887|SUPERIORITY_OR_OTHER||Relative Risk|1.02||||0.867|TWO_SIDED|95.0|0.78|1.34|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.34|0.78|0.8670
74089610|NCT03438396|147731976|OTHER|The statistical hypotheses was tested to address ORR \<= 11% vs. ORR \> 11%.||||||0.0002|||||||one-sided exact test|||||||0.0002
73873845|NCT03089541|147289507|SUPERIORITY||Odds Ratio (OR)|1.46||||0.4|TWO_SIDED|95.0|0.59|3.64|||Regression, Logistic|||Comparison on Working/Reading/Studying using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||3.64|0.59|0.40
74009157|NCT00097773|147569073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.67|TWO_SIDED|95.0|0.71|1.71|||Regression, Logistic||odds of a positive culture comparing the cipro group to the placebo group|Null hypothesis is that there is no difference between pooled cipro and placebo treatment groups in the odds of a Pa positive culture over the 18 month study.||1.71|0.71|0.67
74089611|NCT02384941|147732012|SUPERIORITY||Least squares mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|||||Threshold for significance \< 0.05.|MMRM|||||||<0.001
74089612|NCT02384941|147732012|SUPERIORITY||Least squares mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|95.0||||Threshold for significance \< 0.05.|MMRM|||||||< 0.001
74089613|NCT02384941|147732013|SUPERIORITY||Percentage difference|11.8||||0.002|TWO_SIDED|95.0|4.28|19.36||Threshold for significance \< 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint of each treatment comparison was statistically significant at 0.05 level.||19.36|4.28|0.002
74089614|NCT02384941|147732013|SUPERIORITY||Percentage difference|21.9|||<|0.001|TWO_SIDED|95.0|14.1|29.64||Threshold for significance \< 0.05.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||29.64|14.10|< 0.001
74089615|NCT02384941|147732014|SUPERIORITY||Least squares mean difference|-2.35|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-2.85|-1.85||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-1.85|-2.85|< 0.001
74089616|NCT02384941|147732014|SUPERIORITY||Least squares mean difference|-3.45|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-3.95|-2.94||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-2.94|-3.95|< 0.001
74089617|NCT02384941|147732015|SUPERIORITY||Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.917||0.1|TWO_SIDED|95.0|-3.3|0.3||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||0.30|-3.30|0.10
74089618|NCT02384941|147732015|SUPERIORITY||Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.916|<|0.001|TWO_SIDED|95.0|-5.09|-1.5||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-1.50|-5.09|< 0.001
74089619|NCT02384941|147732016|SUPERIORITY||Least squares mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.5|-0.48||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-0.48|-1.50|< 0.001
74089620|NCT02384941|147732017|SUPERIORITY||Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.8|3.3||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||3.3|1.8|< 0.001
73873846|NCT03089541|147289507|SUPERIORITY||Odds Ratio (OR)|1.34||||0.6|TWO_SIDED|95.0|0.51|3.53|||Regression, Logistic|||Comparison on Socializing using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||3.53|0.51|0.60
73954824|NCT00797225|147444831|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.0023|TWO_SIDED|95.0|-0.41|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.09|-0.41|0.0023
73954825|NCT00797225|147444832|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.24|-0.69|< 0.0001
73954826|NCT00797225|147444832|SUPERIORITY||LS mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.73|-0.27|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.27|-0.73|< 0.0001
74033550|NCT00905307|147619887|SUPERIORITY_OR_OTHER||Relative Risk|1.15||||0.3892|TWO_SIDED|95.0|0.85|1.56|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.56|0.85|0.3892
74089621|NCT02384941|147732018|SUPERIORITY||Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.0|-0.5||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-0.5|-1.0|< 0.001
73954827|NCT00797225|147444832|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.71|-0.25|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.25|-0.71|< 0.0001
73954828|NCT00797225|147444832|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.23|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.23|-0.69|< 0.0001
73954829|NCT00797225|147444832|SUPERIORITY||LS mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.87|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.40|-0.87|< 0.0001
73954830|NCT00797225|147444832|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.59|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.59|-1.04|< 0.0001
74089622|NCT02493777|147732020|SUPERIORITY||||||<|0.001|||||||Mixed model repeated measures analysis|||||||<0.001
73954831|NCT00797225|147444832|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.12||0.0005|TWO_SIDED|95.0|-0.65|-0.18|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.18|-0.65|0.0005
73954832|NCT00797225|147444832|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.76|-0.29|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.29|-0.76|< 0.0001
74089623|NCT02493777|147732021|SUPERIORITY||||||<|0.001|||||||Mixed model repeated measures analysis|||||||<0.001
74089624|NCT00754494|147732031|SUPERIORITY_OR_OTHER|||||||0.762|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.762
73873847|NCT03089541|147289507|SUPERIORITY||Odds Ratio (OR)|1.8||||0.06|TWO_SIDED|95.0|0.96|3.38|||Regression, Logistic|||Model on Public Space adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7)). The significance level was 0.05.||3.38|0.96|0.06
73873848|NCT02119663|147289508|OTHER||Hazard Ratio (HR)|1.584|||||TWO_SIDED|95.0|0.886|2.83||||||||2.830|0.886|
73954833|NCT00797225|147444832|SUPERIORITY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.02|-0.56|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.56|-1.02|< 0.0001
73981547|NCT01159600|147508309|SUPERIORITY_OR_OTHER||Mean difference|-13.06|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|97.5|-19.15|-6.98||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-6.98|-19.15|<0.0001
73981548|NCT01159600|147508310|SUPERIORITY_OR_OTHER||Mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.72|-0.42||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR (renal function), geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.42|-0.72|<0.0001
73954834|NCT00797225|147444833|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.0011|TWO_SIDED|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.13|-0.51|0.0011
73954835|NCT00797225|147444833|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.13|-0.51|0.0010
73954836|NCT00797225|147444833|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.57|-0.19|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.19|-0.57|< 0.0001
73981549|NCT01159600|147508310|SUPERIORITY_OR_OTHER||Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.79|-0.48||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.48|-0.79|<0.0001
73981550|NCT01159600|147508310|SUPERIORITY_OR_OTHER||Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.79|-0.49||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.49|-0.79|<0.0001
73981551|NCT01159600|147508310|SUPERIORITY_OR_OTHER||Mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.74|-0.44||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.44|-0.74|<0.0001
74009158|NCT00097773|147569074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.18|TWO_SIDED|95.0|0.58|1.11|||Regression, Cox|No interaction with ciprofloxacin usage was observed.|Hazard ratio comparing cycled to culture based therapy|The analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation.||1.11|0.58|0.18
74009159|NCT00097773|147569074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.12|TWO_SIDED|95.0|0.94|1.78|||Regression, Cox||Hazard ratio comparing cipro to placebo.|This analysis was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.||1.78|0.94|0.12
74009160|NCT00617604|147569091|SUPERIORITY_OR_OTHER||Difference|3.9|||||TWO_SIDED|90.0|-2.5|10.3||||||||10.3|-2.5|
73954837|NCT00797225|147444833|SUPERIORITY||-0.33|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.0007|TWO_SIDED|95.0|-0.52|-0.14|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.14|-0.52|0.0007
73954838|NCT00797225|147444833|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.62|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.24|-0.62|< 0.0001
73981552|NCT03072238|147508336|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0335|TWO_SIDED|95.0|0.61|0.98|||Log Rank|||||0.98|0.61|0.0335
73981553|NCT03072238|147508337|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0431|TWO_SIDED|95.0|0.71|0.99|||Log Rank|||||0.99|0.71|0.0431
73981554|NCT03072238|147508338|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.5698|TWO_SIDED|95.0|0.76|1.17|||Log Rank|||||1.17|0.76|0.5698
73981555|NCT03072238|147508339|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2515|TWO_SIDED|95.0|0.79|1.07|||Log Rank|||||1.07|0.79|0.2515
73981556|NCT03072238|147508340|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.601|TWO_SIDED|95.0|0.58|1.01|||Log Rank|||||1.01|0.58|0.6010
73981557|NCT03072238|147508341|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.1723|TWO_SIDED|95.0|0.72|1.06|||Log Rank|||||1.06|0.72|0.1723
73981558|NCT03072238|147508342|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1566|TWO_SIDED|95.0|0.65|1.07|||Log Rank|||||1.07|0.65|0.1566
74089625|NCT00754494|147732031|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.125
73954839|NCT00797225|147444833|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.73|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.35|-0.73|< 0.0001
73981559|NCT03072238|147508343|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0419|TWO_SIDED|95.0|0.69|0.99|||Log Rank|||||0.99|0.69|0.0419
73981560|NCT03072238|147508344|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.3198|TWO_SIDED|95.0|0.89|1.45|||Log Rank|||||1.45|0.89|0.3198
73981561|NCT03072238|147508345|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.0071|TWO_SIDED|95.0|1.06|1.47|||Log Rank|||||1.47|1.06|0.0071
73981562|NCT03072238|147508346|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0045|TWO_SIDED|95.0|0.59|0.91|||Log Rank|||||0.91|0.59|0.0045
73981563|NCT03072238|147508347|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.83|||Log Rank|||||0.83|0.61|< 0.0001
73981564|NCT03072238|147508348|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.1359|TWO_SIDED|95.0|0.57|1.08|||Log Rank|||||1.08|0.57|0.1359
73981565|NCT03072238|147508349|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1398|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||||1.06|0.68|0.1398
73981566|NCT03072238|147508350|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8239|TWO_SIDED|95.0|0.61|1.48|||Log Rank|||||1.48|0.61|0.8239
73981567|NCT03072238|147508351|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6018|TWO_SIDED|95.0|0.66|1.27|||Log Rank|||||1.27|0.66|0.6018
73981568|NCT03072238|147508352|SUPERIORITY||Difference in Overall Response Rate|20.93||||0.003|TWO_SIDED|95.0|6.2|35.65|||Cochran-Mantel-Haenszel|||||35.65|6.20|0.0030
73981569|NCT03072238|147508353|SUPERIORITY||Difference in Overall Response Rate|16.46||||0.0008|TWO_SIDED|95.0|6.66|26.27|||Cochran-Mantel-Haenszel|||||26.27|6.66|0.0008
73981570|NCT03072238|147508356|SUPERIORITY||Difference in Overall Response Rate|11.81||||0.0012|TWO_SIDED|95.0|4.34|19.29|||Cochran-Mantel-Haenszel|||||19.29|4.34|0.0012
73981571|NCT03072238|147508357|SUPERIORITY||Difference in Overall Response Rate|5.87||||0.0178|TWO_SIDED|95.0|0.83|10.9|||Cochran-Mantel-Haenszel|||||10.90|0.83|0.0178
73981572|NCT03072238|147508358|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0246|TWO_SIDED|95.0|0.45|0.95|||Log Rank|||||0.95|0.45|0.0246
73981573|NCT00307489|147508369|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||.544
73981574|NCT00307489|147508370|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.208
73981575|NCT00307489|147508371|SUPERIORITY_OR_OTHER|||||||0.712||95.0||||Controlling for baseline HBeAg and prior lamivudine use.|van Elteren|||||||0.712
73981576|NCT00307489|147508372|SUPERIORITY_OR_OTHER|||||||0.988||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.988
73981577|NCT00307489|147508373|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||Controlling for baseline HBeAg status and prior lamivudine use|Cochran-Mantel-Haenszel|||||||0.423
73981578|NCT00307489|147508374|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.109
73981579|NCT00307489|147508375|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||Cochran-Mantel-Haenszel|Controlling for baseline HBeAg and prior lamivudine use.||||||0.952
73981580|NCT00307489|147508376|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.655
73981581|NCT00307489|147508377|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.401
73981582|NCT00307489|147508378|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.401
74009161|NCT00617604|147569092|SUPERIORITY_OR_OTHER||Difference|1.0|||||TWO_SIDED|90.0|-3.1|5.0||||||||5.0|-3.1|
73981583|NCT00307489|147508379|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.103
73981584|NCT00307489|147508380|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.999
73981585|NCT00307489|147508381|SUPERIORITY_OR_OTHER|||||||0.781||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.781
73981586|NCT00307489|147508382|SUPERIORITY_OR_OTHER|||||||0.936||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.936
73981587|NCT00307489|147508383|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.784
73981588|NCT00307489|147508384|SUPERIORITY_OR_OTHER|||||||0.703||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.703
73981589|NCT00307489|147508385|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.254
73981590|NCT00307489|147508386|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.254
73981591|NCT00307489|147508387|SUPERIORITY_OR_OTHER|||||||0.878||95.0|||||Cochran-Mantel-Haenszel|||||||0.878
74089626|NCT00754494|147732031|SUPERIORITY_OR_OTHER|||||||0.855|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.855
73981592|NCT01574105|147508405|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes of 26 in heparin resistant group and 26 in heparin sensitive group achieve 90% power at the 0.025 level of significance to detect a non-inferiority using a one-sided two-sample t-test, assuming a noninferiority margin is 200 milliliters in the postoperative chest tube loss.|||||<|0.1||95.0|||||ANCOVA|||For the analysis of the patient characteristics Wilcoxon, Chi-square and Fischer's exact tests were used. An upper bound of a two-sided 95% confidence interval (CI) of the mean difference between resistant and sensitive groups for all values of chest tube losses was computed by analysis of covariance (ANCOVA), and compared with pre-specified noninferiority limits. Covariates in the ANCOVA model included patient characteristics differing between two groups with a p-value \<0.1.||||<0.1
73981593|NCT04351243|147508407|SUPERIORITY||Risk Difference (RD)|0.05||||0.1885|TWO_SIDED|95.0|-0.06|0.17||one-sided p value|Mantel Haenszel|||||0.17|-0.06|0.1885
73981594|NCT01690000|147508411|SUPERIORITY_OR_OTHER||||||<|0.05||||||The p-value was calculated|t-test, 2 sided|||The p-value was calculated||||<0.05
73981595|NCT04540952|147508437|SUPERIORITY|Power analysis indicated that with a sample size of 34 per arm, would provide 81% power to detect an effect size of 0.7 (0.7\*SD of fluid deficit) with a two-sided, two sample t test (a=0.05).|Mean Difference (Final Values)|11.3||||0.93|TWO_SIDED|95.0|-260.7|283.4|||t-test, 2 sided|||||283.4|-260.7|0.93
73981596|NCT00080119|147508463|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.93|TWO_SIDED|95.0|0.67|1.44||Threshold p-value for significance = 0.0492|Log Rank||Hazard ratio for INH relative to Placebo|||1.44|0.67|0.93
73981597|NCT00080119|147508464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.43|TWO_SIDED|95.0|0.55|1.3||Threshold p-value for significance = 0.0493|Log Rank||Hazard ratio for INH relative to Placebo|||1.30|0.55|0.43
73981598|NCT02009332|147508541|OTHER||maximum deliverable dose (MDD)|400.0|||||TWO_SIDED||||||||Maximum deliverable dose (MDD) was not reached in the Phase 1 study as no DLTs were observed in any of the dose groups up to ABI-009 400 mg/week.|||||
73981599|NCT00248794|147508551|SUPERIORITY_OR_OTHER||||||<|0.97|||||||ANOVA|||||||<.97
73981600|NCT00248794|147508552|SUPERIORITY_OR_OTHER|||||||0.77|||||||ANOVA|||||||.77
73981601|NCT03449979|147508558|SUPERIORITY|||||||0.0852|||||||ANOVA|degrees of freedom = (1,39); F-statistic = 3.119||Interaction in the effect of tACS on left frontal alpha oscillation in the depressed group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.||||0.0852
73981602|NCT03449979|147508558|SUPERIORITY|||||||0.6676|||||||ANOVA|degrees of freedom = (1,39); F-statistic = 0.187||Interaction in the effect of tACS on left frontal alpha oscillation in the healthy group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.||||0.6676
73981603|NCT03449979|147508558|SUPERIORITY|||||||0.929||||||degrees of freedom = (1,41); F-statistic = 0.008|ANOVA|||Main effect of alpha-tACS on session (before and after) on left frontal alpha oscillations across both groups (healthy and patient).||||0.929
73981604|NCT03449979|147508558|SUPERIORITY|||||||0.195|||||||t-test, 1 sided|degrees of freedom = 20; t-statistic = -0.08789||Difference in alpha oscillations after versus before in the depressed cohort (one-tailed Student's t-test) with the hypothesis to decrease pathologically elevate left frontal alpha oscillations||||0.1950
73981605|NCT03449979|147508558|SUPERIORITY|||||||0.8603|||||||t-test, 1 sided|degrees of freedom = 20; t-statistic = 1.1117||Difference in alpha oscillations after versus before in the healthy cohort (one-tailed Student's t-test) run as a control analysis||||0.8603
73981606|NCT00700999|147508573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|STANDARD_DEVIATION|0.9||0.001|TWO_SIDED|95.0|-1.38|-0.45|||t-test, 2 sided|||||-0.45|-1.38|.001
73981607|NCT00700999|147508573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|1.78||0.869|TWO_SIDED|95.0|-0.84|0.99|||t-test, 2 sided|||||.99|-.84|.869
73981608|NCT02432183|147508605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||Kruskal-Wallis|post-hoc comparison with Dunn's multiple comparison test: p=0.0326 between arm 1 and 2; p=0.0147 between arm 1 and 3||||||0.0061
74009162|NCT00617604|147569093|SUPERIORITY_OR_OTHER||Difference|3.0|||||TWO_SIDED|90.0|-4.0|10.1||||||||10.1|-4.0|
74009163|NCT00617604|147569094|SUPERIORITY_OR_OTHER||Difference|1.0|||||TWO_SIDED|90.0|-0.6|2.5||||||||2.5|-0.6|
73981609|NCT01133678|147508608|OTHER|||||||0.19||||||A recommendation to stop the trial early was stipulated if the conditional power at the interim analysis (after 50 patients) was \<10% using a stochastic curtailment approach.. This would occur if the interim test statistic is t \< -0.287.|t-test, 2 sided|t-statistic = -1.330, exceeding threshold (\<-0.287, conditional power\<10%) for early termination.||||||0.190
73981610|NCT01280656|147508628|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
73981611|NCT01280656|147508629|SUPERIORITY_OR_OTHER|||||||0.693|||||||Chi-squared|||||||0.693
73981612|NCT01280656|147508631|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||Chi-squared|||||||0.573
73981613|NCT01280656|147508633|SUPERIORITY_OR_OTHER|||||||0.982|TWO_SIDED||||||Chi-squared|||Mean at the site||||0.982
73981614|NCT01280656|147508633|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Chi-squared|||Mean at home||||0.012
73981615|NCT01280656|147508634|SUPERIORITY_OR_OTHER|||||||0.476|||||||t-test, 2 sided|||Responders vs Non-responders||||0.476
73981616|NCT01280656|147508634|SUPERIORITY_OR_OTHER|||||||0.32|||||||t-test, 2 sided|||Responders vs Non-Responders||||0.320
73981617|NCT01280656|147508635|SUPERIORITY_OR_OTHER|||||||0.792|TWO_SIDED||||||Chi-squared|||||||0.792
73981618|NCT01280656|147508636|SUPERIORITY_OR_OTHER|||||||0.202|TWO_SIDED||||||Chi-squared|||||||0.202
73981619|NCT01280656|147508637|SUPERIORITY_OR_OTHER|||||||0.921|TWO_SIDED||||||Chi-squared|||||||0.921
73981620|NCT01280656|147508638|SUPERIORITY_OR_OTHER|||||||0.202|TWO_SIDED||||||Chi-squared|||||||0.202
73981621|NCT01280656|147508639|SUPERIORITY_OR_OTHER|||||||0.973|TWO_SIDED||||||Chi-squared|||Total||||0.973
73981622|NCT01970527|147508645|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
73981623|NCT01970527|147508647|SUPERIORITY|||||||0.71|||||||Log Rank|||||||0.71
73981624|NCT01964547|147508648|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size is adequate to confirm the non-inferiority of Sativex with a clinical relevant reduction delta of 10%, assuming there is no difference between treatments in the actual change in cognition and also assuming a standard deviation for treatment difference of 10, using a one-tailed 2.5% significance level and power of 90%. Sativex is deemed to be non-inferior to placebo if the lower 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is greater than -10%.|Estimated mean treatment difference|-1.47|STANDARD_ERROR_OF_MEAN|2.492|||ONE_SIDED|97.5|-6.41||||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate. The planned sample size was 120 participants(60 patients in the Sativex arm and 60 in the placebo arm).|||-6.41|
73981625|NCT01964547|147508649|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sativex is deemed to be non-inferior to placebo if the upper 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is less than +5%.|Estimated mean treatment difference|-0.29|STANDARD_ERROR_OF_MEAN|1.323|||ONE_SIDED|97.5||2.33|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.||2.33||
73981626|NCT01964547|147508650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.02||||0.0001|TWO_SIDED|95.0|1.96|8.22|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||8.22|1.96|0.0001
73981627|NCT01964547|147508651|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.79||||0.0142|TWO_SIDED|95.0|1.23|6.31|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||6.31|1.23|0.0142
73981628|NCT01964547|147508652|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.07||||0.0019|TWO_SIDED|95.0|1.51|6.21|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||6.21|1.51|0.0019
73981629|NCT01964547|147508653|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.36|STANDARD_ERROR_OF_MEAN|1.88||0.212|TWO_SIDED|95.0|-6.09|1.37|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.||1.37|-6.09|0.212
73981630|NCT01964547|147508656|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|4.88|STANDARD_ERROR_OF_MEAN|8.25||0.556|TWO_SIDED|95.0|-11.51|21.27|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and centre grouping as factors and baseline score as covariate.||21.27|-11.51|0.556
73981631|NCT01964547|147508656|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann median difference|-1.0||||0.088|TWO_SIDED|95.0|-3.0|0.0|||Wilcoxon (Mann-Whitney)|||The change at end of treatment was compared between treatment groups using non-parametric methods as the distribution of data was non-normal.||0|-3|0.088
73981632|NCT01115309|147508659|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
73981633|NCT01115309|147508660|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
73981634|NCT01307800|147508733|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.1|STANDARD_ERROR_OF_MEAN|2.4||0.994|TWO_SIDED|95.0|-0.5|8.8||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 1-sided alpha level of 0.025, with adjustment for multiplicity by applying the Step-down Dunnett procedure.|Mixed Models Analysis|||||8.8|-0.5|0.994
73981635|NCT01307800|147508733|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.5||0.973|TWO_SIDED|95.0|-1.9|7.9||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 1-sided alpha level of 0.025, with adjustment for multiplicity by applying the Step-down Dunnett procedure.|Mixed Models Analysis|||||7.9|-1.9|0.973
73981636|NCT01307800|147508733|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|2.2||0.896|TWO_SIDED|95.0|-1.6|7.2||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||7.2|-1.6|0.896
73873849|NCT02863328|147289514|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.6|< 0.0001
73954840|NCT00797225|147444833|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.1||0.1319|TWO_SIDED|95.0|-0.34|0.04|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.04|-0.34|0.1319
73954841|NCT00797225|147444833|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.0222|TWO_SIDED|95.0|-0.42|-0.03|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.03|-0.42|0.0222
73954842|NCT00797225|147444833|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.66|-0.28|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.28|-0.66|< 0.0001
73954843|NCT01363479|147444853|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis was rejected (and non inferiority of oral palonosetron 0.50 mg versus I.V. palonosetron 0.25 mg demonstrated), if the lower limit of the 2 sided 99% CI for the difference in proportion of patients with CR (risk difference) was greater (i.e., closer to zero) than 15%.Study had 90% power.|Risk Difference (RD)|3.21|||||TWO_SIDED|99.0|-2.74|9.17|||||The risk difference and the 99% CI calculation were performed using a 2 sided stratum adjusted Cochran Mantel Haenszel (CMH) test including gender and region as strata.|||9.17|-2.74|
73954844|NCT01352507|147444856|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilson Score method|||Null hypothesis (H0): The proportion of participants who chose tadalafil over sildenafil is equal to 0.5 (p = 0.5), versus alternative hypothesis (H1): p is not equal to 0.5 (2-sided test).||||<0.001
73954845|NCT01352507|147444858|SUPERIORITY_OR_OTHER||Least Squares (LS) mean difference|0.02||||0.793|TWO_SIDED|95.0|-0.11|0.15||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.15|-0.11|0.793
73954846|NCT01352507|147444859|SUPERIORITY_OR_OTHER||LS mean difference|0.01||||0.988|TWO_SIDED|95.0|-1.35|1.37||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||1.37|-1.35|0.988
73954847|NCT01352507|147444860|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.102|TWO_SIDED|95.0|-0.01|0.08||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.08|-0.01|0.102
73954848|NCT01352507|147444862|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.861|TWO_SIDED|95.0|-0.22|0.19||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.19|-0.22|0.861
73981637|NCT01307800|147508734|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.5||0.955|TWO_SIDED|95.0|-0.7|9.3||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||9.3|-0.7|0.955
73981638|NCT01307800|147508734|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|2.5||0.912|TWO_SIDED|95.0|-1.6|8.4||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||8.4|-1.6|0.912
73954849|NCT01352507|147444863|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.495|TWO_SIDED|95.0|-0.19|0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.09|-0.19|0.495
73981639|NCT01307800|147508734|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.9|STANDARD_ERROR_OF_MEAN|2.4||0.223|TWO_SIDED|95.0|-1.8|7.7||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||7.7|-1.8|0.223
73981640|NCT01307800|147508735|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.5||0.61|TWO_SIDED|95.0|-3.5|2.6||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.6|-3.5|0.610
73981641|NCT01307800|147508735|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.223|TWO_SIDED|95.0|-2.0|4.6||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.6|-2.0|0.223
73981642|NCT01307800|147508735|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.5||0.414|TWO_SIDED|95.0|-4.2|1.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.7|-4.2|0.414
74009164|NCT00617604|147569095|SUPERIORITY_OR_OTHER||Difference|-5.1|||||TWO_SIDED|90.0|-14.9|4.7||||||||4.7|-14.9|
73954850|NCT01352507|147444864|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.917|TWO_SIDED|95.0|-0.18|0.16||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.16|-0.18|0.917
73954851|NCT01352507|147444865|SUPERIORITY_OR_OTHER||LS mean difference|1.23||||0.391|TWO_SIDED|95.0|-1.58|4.04||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||4.04|-1.58|0.391
73954852|NCT01352507|147444866|SUPERIORITY_OR_OTHER||LS mean difference|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.18|0.09|<0.001
73954853|NCT01352507|147444867|SUPERIORITY_OR_OTHER||LS mean difference|-0.14|||<|0.001|TWO_SIDED|95.0|-0.19|-0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||-0.09|-0.19|<0.001
73954854|NCT01352507|147444868|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.364|TWO_SIDED|95.0|-0.2|0.55||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.55|-0.20|0.364
73954855|NCT01119703|147444869|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-9.1|||||TWO_SIDED|95.0|-13.8|-0.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||-0.7|-13.8|
73954856|NCT01119703|147444870|SUPERIORITY_OR_OTHER||Coefficient of Determination %|17.6|||||TWO_SIDED|95.0|10.6|20.9|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||20.9|10.6|
73954857|NCT01119703|147444871|SUPERIORITY_OR_OTHER||Coefficient of Determination %|27.8|||||TWO_SIDED|95.0|19.6|32.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||32.4|19.6|
73954858|NCT01119703|147444872|SUPERIORITY_OR_OTHER||Coefficient of Determination %|3.3||||||95.0|-2.8|8.5|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||8.5|-2.8|
73954859|NCT01119703|147444873|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.04||||0.66|TWO_SIDED|95.0|-0.2|0.13|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Hepatitis B||0.13|-0.2|0.66
73954860|NCT01119703|147444873|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.1||||0.26|TWO_SIDED|95.0|-0.07|0.25|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Cholera||0.25|-0.07|0.26
73954861|NCT01119703|147444873|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.4|||<|0.001|TWO_SIDED|95.0|0.26|0.53|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Tetanus||0.53|0.26|<0.001
73954862|NCT01119703|147444873|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.17||||0.04|TWO_SIDED|95.0|-0.32|-0.01|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Cholera||-0.01|-0.32|0.04
73954863|NCT01119703|147444873|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.09||||0.3|TWO_SIDED|95.0|-0.25|0.08|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Tetanus||0.08|-0.25|0.30
73954864|NCT01119703|147444873|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.08||||0.36|TWO_SIDED|95.0|-0.09|0.24|||Fisher's Z-transformation||Within-participant rank correlation|Cholera versus Tetanus||0.24|-0.09|0.36
73954865|NCT01119703|147444874|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-9.5|||||TWO_SIDED|95.0|-16.6|-2.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||-2.7|-16.6|
73954866|NCT01119703|147444875|SUPERIORITY_OR_OTHER||Coefficient of Determination %|23.7|||||TWO_SIDED|95.0|14.0|29.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||29.7|14.0|
73954867|NCT01119703|147444876|SUPERIORITY_OR_OTHER||Coefficient of Determination %|36.7|||||TWO_SIDED|95.0|28.7|41.5|||||Crossvalidated;negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||41.5|28.7|
73954868|NCT01119703|147444877|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-2.2|||||TWO_SIDED|95.0|-7.8|4.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||4.4|-7.8|
73981643|NCT01307800|147508736|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.603|TWO_SIDED|95.0|-3.7|2.8||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.8|-3.7|0.603
73981644|NCT01307800|147508736|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.7||0.192|TWO_SIDED|95.0|-1.9|4.8||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.8|-1.9|0.192
73981645|NCT01307800|147508736|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.619|TWO_SIDED|95.0|-3.9|2.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.3|-3.9|0.619
73981646|NCT01307800|147508737|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.5|STANDARD_ERROR_OF_MEAN|4.1||0.022|TWO_SIDED|95.0|1.4|17.6||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||17.6|1.4|0.022
73981647|NCT01307800|147508737|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.7|STANDARD_ERROR_OF_MEAN|4.6||0.061|TWO_SIDED|95.0|-0.4|17.8||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||17.8|-0.4|0.061
73981648|NCT01307800|147508737|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.2|STANDARD_ERROR_OF_MEAN|4.1||0.304|TWO_SIDED|95.0|-3.9|12.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||12.3|-3.9|0.304
73981649|NCT01307800|147508738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6|STANDARD_ERROR_OF_MEAN|0.8||0.036|TWO_SIDED|95.0|0.1|3.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||3.1|0.1|0.036
73981650|NCT01307800|147508738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.616|TWO_SIDED|95.0|-1.2|2.0||The comparison between 40 mg LY2140023, BID and placebo for change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.0|-1.2|0.616
73981651|NCT01307800|147508738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.7||0.307|TWO_SIDED|95.0|-0.7|2.2||The comparison between 10 mg LY2140023, BID and placebo for change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.2|-0.7|0.307
73981652|NCT01307800|147508738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.7||0.382|TWO_SIDED|95.0|-0.8|2.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.1|-0.8|0.382
73981653|NCT01307800|147508738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.8||0.107|TWO_SIDED|95.0|-0.3|2.8||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.8|-0.3|0.107
73981654|NCT01307800|147508738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.436|TWO_SIDED|95.0|-0.9|2.0||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.0|-0.9|0.436
73981655|NCT01307800|147508738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.3|STANDARD_ERROR_OF_MEAN|1.3||0.073|TWO_SIDED|95.0|-0.2|4.9||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.9|-0.2|0.073
73981656|NCT01307800|147508738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.4||0.28|TWO_SIDED|95.0|-1.2|4.2||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.2|-1.2|0.280
73981657|NCT01307800|147508738|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6|STANDARD_ERROR_OF_MEAN|1.3||0.209|TWO_SIDED|95.0|-0.9|4.0||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.0|-0.9|0.209
73981658|NCT01307800|147508739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.137||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||0.137
73981659|NCT01307800|147508739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.824||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||0.824
73981660|NCT01307800|147508739|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||>0.999
73981661|NCT01307800|147508741|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.34|TWO_SIDED|95.0|-0.13|0.38||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.38|-0.13|0.340
73981662|NCT01307800|147508741|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.14||0.659|TWO_SIDED|95.0|-0.33|0.21||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.21|-0.33|0.659
73981663|NCT01307800|147508741|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.413|TWO_SIDED|95.0|-0.14|0.35||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.35|-0.14|0.413
73981664|NCT01307800|147508742|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.5||0.91|TWO_SIDED|95.0|-3.1|2.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.7|-3.1|0.910
73981665|NCT01307800|147508742|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.6||0.265|TWO_SIDED|95.0|-4.9|1.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.3|-4.9|0.265
73981666|NCT01307800|147508742|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.4||0.531|TWO_SIDED|95.0|-3.7|1.9||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.9|-3.7|0.531
73981667|NCT01307800|147508743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|2.62||0.983|TWO_SIDED|95.0|-5.21|5.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||5.10|-5.21|0.983
73981668|NCT01307800|147508743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|2.74||0.351|TWO_SIDED|95.0|-7.94|2.83||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||2.83|-7.94|0.351
73873850|NCT02863328|147289514|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.6|< 0.0001
73873851|NCT02863328|147289514|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
73954869|NCT02820051|147444885|SUPERIORITY|||||||0.281||||||threshold for statistical significance: \< 0.05|Wilcoxon (Mann-Whitney)|||The sample was calculated with alpha 0.05, beta 0.20, standard deviation of 7.3,8 minimum PtcCO2 difference to detect of 5 mmHg, loss to follow-up estimated 0.20, and two-tails. According to the above, the sample size was 42 patients per group.|We tested normal distribution with the Kolmogorov-Smirnov test. Data are shown as means and standard deviations for variables with normal distribution and as medians and interquartile ranges for non-normal variables. We used the t-test, the Mann-Whitney U-test, ANOVA, or chi-square as indicated. We defined a statistically significant difference as a P value \< 0.05. The analysis was performed using SPSS version 18.0 for Windows (SPSS Inc., Chicago, IL).|||0.281
73954870|NCT02820051|147444886|SUPERIORITY|We used the t-test, the Mann-Whitney U-test, ANOVA, or chi-square as indicated. We defined a statistically significant difference as a P value \< 0.05.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73954871|NCT02820051|147444887|SUPERIORITY|T test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73954872|NCT01222247|147444888|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.8||||0.02|TWO_SIDED|95.0|0.66|0.97|||Chi-squared|||Analysis for Primary Outcome composite||0.97|0.66|0.02
73954873|NCT01222247|147444888|SUPERIORITY||Risk Ratio (RR)|0.77||||0.01|TWO_SIDED|95.0|0.63|0.95|||Chi-squared|||Analysis for CPAP or high-flow nasal cannula||0.95|0.63|0.01
73954874|NCT01222247|147444888|SUPERIORITY||Risk Ratio (RR)|0.77||||0.17|TWO_SIDED|95.0|0.53|1.12|||Chi-squared|||Analysis for Fraction of inspired oxygen||1.12|0.53|0.17
73954875|NCT01222247|147444888|SUPERIORITY||Risk Ratio (RR)|0.78||||0.26|TWO_SIDED|95.0|0.5|1.21|||Chi-squared|||Analysis for mechanical ventilation||1.21|0.50|0.26
73954876|NCT01222247|147444889|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.67|||<|0.001|TWO_SIDED|95.0|0.53|0.84|||Chi-squared|||||0.84|0.53|<0.001
73954877|NCT01222247|147444890|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.003|TWO_SIDED|95.0|0.66|0.92|||Chi-squared|||||0.92|0.66|0.003
73954878|NCT01222247|147444891|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.87||||0.36|TWO_SIDED|95.0|0.65|1.17|||Chi-squared|||||1.17|0.65|0.36
74039501|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.0893|TWO_SIDED|95.0|-0.18|0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.18|0.0893
73954879|NCT01222247|147444892|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.68||||0.002|TWO_SIDED|95.0|0.53|0.87|||Chi-squared|||||0.87|0.53|0.002
73954880|NCT01222247|147444893|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.57|TWO_SIDED|95.0|0.55|1.39|||Chi-squared|||||1.39|0.55|0.57
73954881|NCT01222247|147444894|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.22||||0.04|TWO_SIDED|95.0|0.02|0.92|||Chi-squared|||||0.92|0.02|0.04
73954882|NCT01222247|147444895|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.45||||0.1|TWO_SIDED|95.0|0.17|1.19|||Chi-squared|||||1.19|0.17|0.10
73954883|NCT01222247|147444896|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.59||||0.03|TWO_SIDED|95.0|0.37|0.96|||Chi-squared|||||0.96|0.37|0.03
73954884|NCT01222247|147444897|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.004|TWO_SIDED|95.0|0.66|0.93|||Chi-squared|||||0.93|0.66|0.004
73954885|NCT01222247|147444898|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.82||||0.74|TWO_SIDED|95.0|0.25|2.68|||Chi-squared|||||2.68|0.25|0.74
73954886|NCT01222247|147444899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Chi-squared|||||||0.50
73954887|NCT01222247|147444900|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
73954888|NCT01222247|147444901|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14||||0.13|TWO_SIDED|95.0|0.96|1.34|||Chi-squared|||||1.34|0.96|0.13
73954889|NCT01222247|147444902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||Chi-squared|||||||0.10
73954890|NCT01222247|147444904|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.8||||0.62|TWO_SIDED|95.0|0.33|1.93|||Chi-squared|||||1.93|0.33|0.62
73954891|NCT01222247|147444906|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.4|TWO_SIDED|95.0|0.66|1.18|||Chi-squared|||||1.18|0.66|0.40
73954892|NCT01222247|147444907|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.6|||<|0.001|TWO_SIDED|95.0|1.37|1.87|||Chi-squared|||||1.87|1.37|<0.001
73954893|NCT01222247|147444908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73954894|NCT01222247|147444909|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93||||0.4|TWO_SIDED|95.0|0.78|1.1|||Chi-squared|||||1.10|0.78|0.40
73954895|NCT01222247|147444910|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.4|||Chi-squared|||||1.40|0.95|0.15
73954896|NCT01222247|147444911|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.16||||0.24|TWO_SIDED|95.0|0.91|1.47|||Chi-squared|||||1.47|0.91|0.24
73873852|NCT02863328|147289514|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
73954897|NCT01222247|147444912|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93||||0.09|TWO_SIDED|95.0|0.85|1.01|||Chi-squared|||Analysis for NICU stay of any duration||1.01|0.85|0.09
73954898|NCT01222247|147444912|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.89||||0.03|TWO_SIDED|95.0|0.8|0.98|||Chi-squared|||Analysis for duration greater than or equal to 3 days||0.98|0.80|0.03
73954899|NCT01222247|147444913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
73954900|NCT01222247|147444914|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.61||||0.08|TWO_SIDED|95.0|0.35|1.07|||Chi-squared|||Statistical analysis for chorioamnionitis||1.07|0.35|0.08
73954901|NCT01222247|147444914|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.96|TWO_SIDED|95.0|0.49|1.95|||Chi-squared|||Analysis for Postpartum Endometritis||1.95|0.49|0.96
73954902|NCT01222247|147444914|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.56|TWO_SIDED|95.0|0.93|1.15|||Chi-squared|||Statistical analysis for cesarean delivery||1.15|0.93|0.56
73954903|NCT01222247|147444915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Analysis for interval from randomization to delivery||||0.57
73954904|NCT01222247|147444916|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
73954905|NCT04939428|147444917|SUPERIORITY||Confidence Interval|-2.0|||=|0.0848|TWO_SIDED|95.0|-5.0|0.9|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||0.9|-5|= 0.0848
73954906|NCT04939428|147444918|OTHER|Estimated differences and confidence intervals are provided.|Confidence Interval|-1.4|||||TWO_SIDED|95.0|-4.8|2.0|||Miettinen & Nurminen method|||95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.||2.0|-4.8|
73954907|NCT04939428|147444919|OTHER|Estimated differences and confidence intervals are provided|Confidence Interval|0.3|||||TWO_SIDED|95.0|-0.4|1.0|||Miettinen & Nurminen method.|||95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.||1.0|-0.4|
73954908|NCT04939428|147444920|SUPERIORITY||Confidence Interval|-3.2|||=|0.0205|TWO_SIDED|95.0|-6.3|-0.1|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||-0.1|-6.3|= 0.0205
73954909|NCT04939428|147444921|OTHER|Adjusted differences and the corresponding confidence intervals.|Confidence Interval|-2.2|||||TWO_SIDED|95.0|-5.4|1.0|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||1.0|-5.4|
73954910|NCT04939428|147444922|OTHER|Adjusted differences and the corresponding confidence intervals|Confidence Interval|-3.0|||||TWO_SIDED|95.0|-6.9|0.8||||||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||0.8|-6.9|
73981669|NCT01307800|147508743|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.12|STANDARD_ERROR_OF_MEAN|2.54||0.403|TWO_SIDED|95.0|-2.86|7.11||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||7.11|-2.86|0.403
73981670|NCT01307800|147508746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.4||0.021|TWO_SIDED|95.0|-10.4|-0.8||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||-0.8|-10.4|0.021
73981671|NCT01307800|147508746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|2.6||0.487|TWO_SIDED|95.0|-3.3|6.9||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||6.9|-3.3|0.487
73981672|NCT01307800|147508746|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|2.4||0.693|TWO_SIDED|95.0|-5.6|3.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||3.7|-5.6|0.693
73981673|NCT01307800|147508747|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.661|TWO_SIDED|95.0|-0.1|0.06||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.06|-0.10|0.661
73981674|NCT01307800|147508747|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.201|TWO_SIDED|95.0|-0.14|0.03||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.03|-0.14|0.201
73981675|NCT01307800|147508747|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.697|TWO_SIDED|95.0|-0.09|0.06||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.06|-0.09|0.697
73981676|NCT01307800|147508748|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.694|TWO_SIDED|95.0|-0.2|0.31||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.31|-0.20|0.694
73981677|NCT01307800|147508748|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.596|TWO_SIDED|95.0|-0.34|0.2||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.20|-0.34|0.596
73981678|NCT01307800|147508748|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.13||0.055|TWO_SIDED|95.0|0.0|0.49||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.49|0.00|0.055
73873853|NCT02863328|147289515|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.1|||=|0.7593|TWO_SIDED|95.0|-0.7|0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.5|-0.7|= 0.7593
73873854|NCT02863328|147289515|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.4|||=|0.1358|TWO_SIDED|95.0|-1.0|0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.1|-1.0|= 0.1358
73873855|NCT02863328|147289543|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.85||||0.3552|TWO_SIDED|95.0|0.6|1.2||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.20|0.60|0.3552
73873856|NCT02863328|147289544|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.225|TWO_SIDED|95.0|0.47|1.19||Unadjusted two-sided p-value for test of no difference from 1.|Cox proportional hazards model||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.19|0.47|0.2250
73873857|NCT00892775|147289564|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after vaccination was concluded if the lower limit of the 95% confidence interval around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.64|||||TWO_SIDED|95.0|-2.29|1.76||||||||1.76|-2.29|
73873858|NCT00892775|147289564|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.74|||||TWO_SIDED|95.0|-6.14|5.58||||||||5.58|-6.14|
73873859|NCT00892775|147289564|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.32|||||TWO_SIDED|95.0|-1.78|2.08||||||||2.08|-1.78|
73873860|NCT00892775|147289564|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|4.69|||||TWO_SIDED|95.0|0.72|10.34||||||||10.34|0.72|
73954911|NCT04939428|147444923|OTHER|Adjusted differences and the corresponding confidence intervals.|Mean Difference (Final Values)|-10.5|||||TWO_SIDED|95.0|-22.7|2.0|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||2.0|-22.7|
73954912|NCT05302791|147444924|SUPERIORITY|||||||0.609|||||||ANOVA|time x condition ANOVA||||||.609
73954913|NCT05302791|147444925|SUPERIORITY|||||||0.858|||||||ANOVA|time x condition anova||||||.858
73954914|NCT05302791|147444926|SUPERIORITY|||||||0.633|||||||ANOVA|||||||.633
73981679|NCT01307800|147508749|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.929|TWO_SIDED|95.0|-0.27|0.29||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.29|-0.27|0.929
73954915|NCT05302791|147444927|SUPERIORITY|||||||0.076|||||||ANOVA|||||||.076
73954916|NCT05302791|147444928|SUPERIORITY|||||||0.151|||||||ANOVA|||||||.151
73954917|NCT05302791|147444929|SUPERIORITY|||||||0.385|||||||ANOVA|||||||.385
73954918|NCT05302791|147444930|SUPERIORITY|||||||0.665|||||||ANOVA|||||||.665
73954919|NCT05302791|147444931|SUPERIORITY|||||||0.078|||||||ANOVA|||||||.078
73954920|NCT05302791|147444932|SUPERIORITY|||||||0.773|||||||ANOVA|||||||.773
73954921|NCT05302791|147444933|SUPERIORITY|||||||0.118|||||||ANOVA|||||||.118
73981680|NCT01307800|147508749|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.15||0.519|TWO_SIDED|95.0|-0.19|0.38||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.38|-0.19|0.519
74009165|NCT00617604|147569096|SUPERIORITY_OR_OTHER||Difference|-9.4|||||TWO_SIDED|90.0|-18.5|0.0||||||||0.0|-18.5|
73954922|NCT05302791|147444934|SUPERIORITY||||||<|0.001|||||||ANOVA|Time x condition ANOVA||||||<0.001
73954923|NCT05302791|147444935|SUPERIORITY||||||<|0.001|||||||ANOVA|time x condition anova||||||<0.001
73954924|NCT02696785|147444936|SUPERIORITY||Odds Ratio (OR)|2.73||||0.005|TWO_SIDED|95.0|1.35|5.52|||Regression, Logistic|||Overall Work Impairment Score||5.52|1.35|0.005
73954925|NCT02696785|147444936|SUPERIORITY||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|95.0|2.2|9.03|||Regression, Logistic|||Overall Work Impairment Score.||9.03|2.20|<0.001
73954926|NCT02696785|147444936|SUPERIORITY||Odds Ratio (OR)|5.09|||<|0.001|TWO_SIDED|95.0|2.52|10.28|||Regression, Logistic|||Overall Work Impairment Score.||10.28|2.52|<0.001
73873861|NCT00699660|147289574|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Comparison of CAPS/WHODAS vs Nonstructured Interview study arms: linear and logistic mixed effects regression with clinical examiner stratified by study group as a random effect and study group as a fixed effect.|Regression, Linear|Covariates included experience, use of template,tests,reviewing records,age,education, study site,reviewer, and expert reviewer by group interaction.||Our sample size calculation yielded 466 for a power of 0.80 to detect a 10% absolute difference in sensitivity and adjusted for intraclass correlation. The number of covariates in regression models was limited to ensure the effective sample size remained ten times greater than the degrees of freedom in the model.||||<.001
73873862|NCT00699660|147289575|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Logistic|||||||<.01
73981681|NCT01307800|147508749|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.14||0.323|TWO_SIDED|95.0|-0.13|0.4||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.40|-0.13|0.323
73981682|NCT01307800|147508750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758||95.0||||The comparison between 80 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.758
73981683|NCT01307800|147508750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.576||95.0||||The comparison between 40 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.576
73981684|NCT01307800|147508750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.425||95.0||||The comparison between 10 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.425
73873863|NCT00699660|147289576|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Descriptive statistics on mean and standard deviation.|t-test, 2 sided|||||||>.05
73873864|NCT00699660|147289577|SUPERIORITY_OR_OTHER||Slope|47.3|STANDARD_ERROR_OF_MEAN|18.86||0.012|TWO_SIDED|||||0.05 level based on a two tailed test.|Regression, Linear|Covariates included years of experience, use of template, use of tests, age, education, study site.||Estimates of the influence on total time and tests of statistical significance were derived from multilevel mixed-effects linear regression (xtmixed in Stata)||||.012
73873865|NCT00064792|147289583|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The primary outcome variable will be the serum cholesterol/total sterol ratio.||||0.002
73873866|NCT00064792|147289584|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
73954927|NCT02696785|147444936|SUPERIORITY||LSMean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.16|<|0.001|TWO_SIDED|95.0|-13.2|-0.7|||ANCOVA|||Percentage of Activity Impairment||-0.7|-13.2|<0.001
73954928|NCT02696785|147444936|SUPERIORITY||LSMean Difference|-9.3|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|-15.5|-3.0|||ANCOVA|||Percentage of Activity Impairment||-3.0|-15.5|<0.001
73954929|NCT02696785|147444936|SUPERIORITY||LSMean Difference|-8.9|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED|95.0|-15.2|-2.5|||ANCOVA|||Percentage of Activity Impairment||-2.5|-15.2|<0.001
73954930|NCT02696785|147444937|SUPERIORITY||Odds Ratio (OR)|2.3||||0.007|TWO_SIDED|95.0|1.25|4.23|||Regression, Logistic|||||4.23|1.25|0.007
73954931|NCT02696785|147444937|SUPERIORITY||Odds Ratio (OR)|2.78||||0.001|TWO_SIDED|95.0|1.48|5.24|||Regression, Logistic|||||5.24|1.48|0.001
73954932|NCT02696785|147444937|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.001|TWO_SIDED|95.0|1.79|6.41|||Regression, Logistic|||||6.41|1.79|<0.001
73954933|NCT02696785|147444938|SUPERIORITY||LSMean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|95.0|-1.11|-0.57|||Mixed Models Analysis|||||-0.57|-1.11|<0.001
73954934|NCT02696785|147444938|SUPERIORITY||LSMean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-1.25|-0.7|||Mixed Models Analysis|||||-0.70|-1.25|<0.001
73954935|NCT02696785|147444938|SUPERIORITY||LSMean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.18|-0.63|||Mixed Models Analysis|||||-0.63|-1.18|<0.001
73981685|NCT01307800|147508753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.444||95.0||||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) model on rank-transformed change.||||||0.444
73981686|NCT01307800|147508753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||95.0||||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|ANOVA model on rank-transformed change.||||||0.799
73954936|NCT02696785|147444939|SUPERIORITY||Odds Ratio (OR)|2.53||||0.012|TWO_SIDED|95.0|1.23|5.21|||Regression, Logistic|||||5.21|1.23|0.012
73954937|NCT02696785|147444939|SUPERIORITY||Odds Ratio (OR)|3.74|||<|0.001|TWO_SIDED|95.0|1.82|7.7|||Regression, Logistic|||||7.70|1.82|<0.001
73954938|NCT02696785|147444939|SUPERIORITY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|1.91|7.98|||Regression, Logistic|||||7.98|1.91|<0.001
73954939|NCT02696785|147444940|SUPERIORITY||LSMean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.299||0.001|TWO_SIDED|95.0|-1.56|-0.39|||Mixed Models Analysis|||||-0.39|-1.56|0.001
73954940|NCT02696785|147444940|SUPERIORITY||LSMean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.307|<|0.001|TWO_SIDED|95.0|-1.83|-0.62|||Mixed Models Analysis|||||-0.62|-1.83|<0.001
73954941|NCT02696785|147444940|SUPERIORITY||LSMean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.304|<|0.001|TWO_SIDED|95.0|-1.86|-0.67|||Mixed Models Analysis|||||-0.67|-1.86|<0.001
73954942|NCT02696785|147444941|SUPERIORITY||LSMean Difference|7.62||||0.009|TWO_SIDED|95.0|1.67|34.68|||Regression, Logistic|||||34.68|1.67|0.009
73954943|NCT02696785|147444941|SUPERIORITY||Odds Ratio (OR)|8.03||||0.007|TWO_SIDED|95.0|1.75|36.83|||Regression, Logistic|||||36.83|1.75|0.007
73954944|NCT02696785|147444941|SUPERIORITY||Odds Ratio (OR)|5.13||||0.041|TWO_SIDED|95.0|1.07|24.49|||Regression, Logistic|||||24.49|1.07|0.041
73954945|NCT02696785|147444942|SUPERIORITY||LSMean Difference|-2.78|STANDARD_ERROR_OF_MEAN|0.447|<|0.001|TWO_SIDED|95.0|-3.7|-1.9|||ANCOVA|||||-1.9|-3.7|<0.001
73954946|NCT02696785|147444942|SUPERIORITY||LSMean Difference|-2.62|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-3.5|-1.7|||ANCOVA|||||-1.7|-3.5|<0.001
73954947|NCT02696785|147444942|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.452|<|0.001|TWO_SIDED|95.0|-3.3|-1.5|||ANCOVA|||||-1.5|-3.3|<0.001
73954948|NCT02696785|147444943|SUPERIORITY||LSMean Difference|3.2574|STANDARD_ERROR_OF_MEAN|1.0437||0.002|TWO_SIDED|95.0|1.2041|5.3106|||Mixed Models Analysis|||PCS||5.3106|1.2041|0.002
73954949|NCT02696785|147444943|SUPERIORITY||LSMean Difference|4.052|STANDARD_ERROR_OF_MEAN|1.072|<|0.001|TWO_SIDED|95.0|1.9432|6.1608|||Mixed Models Analysis|||PCS||6.1608|1.9432|<0.001
73954950|NCT02696785|147444943|SUPERIORITY||LSMean Difference|4.3254|STANDARD_ERROR_OF_MEAN|1.0641|<|0.001|TWO_SIDED|95.0|2.2321|6.4186|||Mixed Models Analysis|||PCS||6.4186|2.2321|<0.001
73954951|NCT02696785|147444943|SUPERIORITY||LSMean Difference|0.4321|STANDARD_ERROR_OF_MEAN|1.1718||0.713|TWO_SIDED|95.0|-1.8732|2.7373|||Mixed Models Analysis|||MCS||2.7373|-1.8732|0.713
73954952|NCT02696785|147444943|SUPERIORITY||LSMean Difference|0.6273|STANDARD_ERROR_OF_MEAN|1.2028||0.602|TWO_SIDED|95.0|-1.7387|2.9934|||Mixed Models Analysis|||MCS||2.9934|-1.7387|0.602
73954953|NCT02696785|147444943|SUPERIORITY||LSMean Difference|0.4467|STANDARD_ERROR_OF_MEAN|1.1978||0.709|TWO_SIDED|95.0|-1.9097|2.803|||Mixed Models Analysis|||MCS||2.8030|-1.9097|0.709
73954954|NCT02696785|147444944|SUPERIORITY||LSMean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.416||0.012|TWO_SIDED|95.0|-1.87|-0.23|||Mixed Models Analysis|||||-0.23|-1.87|0.012
73954955|NCT02696785|147444944|SUPERIORITY||LSMean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.428||0.01|TWO_SIDED|95.0|-1.95|-0.27|||Mixed Models Analysis|||||-0.27|-1.95|0.010
73954956|NCT02696785|147444944|SUPERIORITY||LSMean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.423|<|0.001|TWO_SIDED|95.0|-2.32|-0.66|||Mixed Models Analysis|||||-0.66|-2.32|<0.001
73954957|NCT02696785|147444945|SUPERIORITY||LSMean Difference|-8.628|STANDARD_ERROR_OF_MEAN|2.6724||0.001|TWO_SIDED|95.0|-13.885|-3.371|||Mixed Models Analysis|||||-3.371|-13.885|0.001
73954958|NCT02696785|147444945|SUPERIORITY||LSMean Difference|-6.635|STANDARD_ERROR_OF_MEAN|2.7438||0.016|TWO_SIDED|95.0|-12.033|-1.238|||Mixed Models Analysis|||||-1.238|-12.033|0.016
73981687|NCT01307800|147508753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0||||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|ANOVA model on rank-transformed change.||||||0.073
73981688|NCT01307800|147508754|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.46||0.761|TWO_SIDED|95.0|-0.76|1.04||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||1.04|-0.76|0.761
73981689|NCT01307800|147508754|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.47||0.761|TWO_SIDED|95.0|-0.78|1.06||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||1.06|-0.78|0.761
73981690|NCT01307800|147508754|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.44||0.489|TWO_SIDED|95.0|-1.17|0.56||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.56|-1.17|0.489
73954959|NCT02696785|147444945|SUPERIORITY||LSMean Difference|-7.991|STANDARD_ERROR_OF_MEAN|2.7248||0.004|TWO_SIDED|95.0|-13.351|-2.631|||Mixed Models Analysis|||||-2.631|-13.351|0.004
73981691|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.77|||||TWO_SIDED|95.0|0.62|0.97|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)||0.97|0.62|
73954960|NCT02696785|147444946|SUPERIORITY||LSMean Difference|-0.367|STANDARD_ERROR_OF_MEAN|0.1143||0.001|TWO_SIDED|95.0|-0.592|-0.142|||Mixed Models Analysis|||||-0.142|-0.592|0.001
73954961|NCT02696785|147444946|SUPERIORITY||LSMean Difference|-0.422|STANDARD_ERROR_OF_MEAN|0.1184|<|0.001|TWO_SIDED|95.0|-0.655|-0.189|||Mixed Models Analysis|||||-0.189|-0.655|<0.001
73954962|NCT02696785|147444946|SUPERIORITY||LSMean Difference|-0.329|STANDARD_ERROR_OF_MEAN|0.1167||0.005|TWO_SIDED|95.0|-0.558|-0.099|||Mixed Models Analysis|||||-0.099|-0.558|0.005
73954963|NCT02696785|147444947|SUPERIORITY||LSMean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.211||0.003|TWO_SIDED|95.0|0.22|1.05|||Mixed Models Analysis|||||1.05|0.22|0.003
74009166|NCT00617604|147569097|SUPERIORITY_OR_OTHER||Difference|-1.9|||||TWO_SIDED|90.0|-7.6|3.8||||||||3.8|-7.6|
74009167|NCT00617604|147569098|SUPERIORITY_OR_OTHER||Difference|-1.8|||||TWO_SIDED|90.0|-8.2|4.6||||||||4.6|-8.2|
73954964|NCT02696785|147444947|SUPERIORITY||LSMean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.219||0.051|TWO_SIDED|95.0|0.0|0.86|||Mixed Models Analysis|||||0.86|-0.00|0.051
73954965|NCT02696785|147444947|SUPERIORITY||LSMean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.215||0.005|TWO_SIDED|95.0|0.18|1.03|||Mixed Models Analysis|||||1.03|0.18|0.005
73954966|NCT02696785|147444948|SUPERIORITY||LSMean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.321||0.039|TWO_SIDED|95.0|-1.3|-0.03|||Mixed Models Analysis|||||-0.03|-1.30|0.039
73954967|NCT02696785|147444948|SUPERIORITY||LSMean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.33||0.057|TWO_SIDED|95.0|-1.28|0.02|||Mixed Models Analysis|||||0.02|-1.28|0.057
73954968|NCT02696785|147444948|SUPERIORITY||LSMean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.327||0.042|TWO_SIDED|95.0|-1.31|-0.03|||Mixed Models Analysis|||||-0.03|-1.31|0.042
73954969|NCT02696785|147444949|SUPERIORITY||LSMean Difference|-5.13|STANDARD_ERROR_OF_MEAN|0.806|<|0.001|TWO_SIDED|95.0|-6.7|-3.5|||ANCOVA|||||-3.5|-6.7|<0.001
73954970|NCT02696785|147444949|SUPERIORITY||LSMean Difference|-4.89|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|-6.5|-3.3|||ANCOVA|||||-3.3|-6.5|<0.001
73954971|NCT02696785|147444949|SUPERIORITY||LSMean Difference|-5.17|STANDARD_ERROR_OF_MEAN|0.816|<|0.001|TWO_SIDED|95.0|-6.8|-3.6|||ANCOVA|||||-3.6|-6.8|<0.001
73954972|NCT02696785|147444950|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.317|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|||||0.5|-1.4|0.317
73954973|NCT02696785|147444950|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.48||0.683|TWO_SIDED|95.0|-1.1|0.8|||Mixed Models Analysis|||||0.8|-1.1|0.683
73954974|NCT02696785|147444950|SUPERIORITY||LSMean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.5|TWO_SIDED|95.0|-1.3|0.6|||Mixed Models Analysis|||||0.6|-1.3|0.500
73954975|NCT02696785|147444951|SUPERIORITY||LSMean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.56||0.154|TWO_SIDED|95.0|-1.9|0.3|||Mixed Models Analysis|||||0.3|-1.9|0.154
73954976|NCT02696785|147444951|SUPERIORITY||LSMean Difference|0.255|STANDARD_ERROR_OF_MEAN|0.56||-0.6|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|||||0.5|-1.8|-0.6
73954977|NCT02696785|147444951|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.58||0.398|TWO_SIDED|95.0|-1.6|0.7|||Mixed Models Analysis|||||0.7|-1.6|0.398
73954978|NCT02696785|147444952|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.76||0.783|TWO_SIDED|95.0|-1.7|1.3|||Mixed Models Analysis|||||1.3|-1.7|0.783
73954979|NCT02696785|147444952|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.78||0.55|TWO_SIDED|95.0|-2.0|1.1|||Mixed Models Analysis|||||1.1|-2.0|0.550
73954980|NCT02696785|147444952|SUPERIORITY||LSMean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.77||0.091|TWO_SIDED|95.0|-2.8|0.2|||Mixed Models Analysis|||||0.2|-2.8|0.091
73954981|NCT02696785|147444954|SUPERIORITY||LSMean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.32||0.027|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis|||||-0.1|-1.3|0.027
73954982|NCT02696785|147444954|SUPERIORITY||LSMean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.33||0.002|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||||-0.4|-1.7|0.002
73954983|NCT02696785|147444954|SUPERIORITY||LSMean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.33||0.035|TWO_SIDED|95.0|-1.3|0.0|||Mixed Models Analysis|||||-0.0|-1.3|0.035
73954984|NCT02696785|147444955|SUPERIORITY||LSMean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.57||0.041|TWO_SIDED|95.0|-2.3|0.0|||Mixed Models Analysis|||||-0.0|-2.3|0.041
73954985|NCT02696785|147444955|SUPERIORITY||LSMean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.59||0.125|TWO_SIDED|95.0|-2.1|0.3|||Mixed Models Analysis|||||0.3|-2.1|0.125
73954986|NCT02696785|147444955|SUPERIORITY||LSMean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.013|TWO_SIDED|95.0|-2.6|-0.3|||Mixed Models Analysis|||||-0.3|-2.6|0.013
73954987|NCT02696785|147444956|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|3.082||0.989|TWO_SIDED|95.0|-6.03|6.12|||Mixed Models Analysis|||||6.12|-6.03|0.989
73954988|NCT02696785|147444956|SUPERIORITY||LSMean Difference|2.5|STANDARD_ERROR_OF_MEAN|3.146||0.429|TWO_SIDED|95.0|-3.71|8.7|||Mixed Models Analysis|||||8.70|-3.71|0.429
73954989|NCT02696785|147444956|SUPERIORITY||LSMean Difference|-5.47|STANDARD_ERROR_OF_MEAN|3.27||0.096|TWO_SIDED|95.0|-11.92|0.98|||Mixed Models Analysis|||||0.98|-11.92|0.096
73954990|NCT02696785|147444960|SUPERIORITY||LSMean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.76||0.166|TWO_SIDED|95.0|-2.6|0.4|||Mixed Models Analysis|||||0.4|-2.6|0.166
73954991|NCT02696785|147444960|SUPERIORITY||LSMean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.73||0.011|TWO_SIDED|95.0|-3.4|-0.4|||Mixed Models Analysis|||||-0.4|-3.4|0.011
73954992|NCT02696785|147444960|SUPERIORITY||LSMean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.77||0.182|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||||0.5|-2.6|0.182
73954993|NCT02696785|147444961|SUPERIORITY||LSMean Difference|-10.07|STANDARD_ERROR_OF_MEAN|1.588|<|0.001|TWO_SIDED|95.0|-13.2|-6.9|||ANCOVA|||||-6.9|-13.2|<0.001
73954994|NCT02696785|147444961|SUPERIORITY||LSMean Difference|-9.51|STANDARD_ERROR_OF_MEAN|1.591|<|0.001|TWO_SIDED|95.0|-12.6|-6.4|||ANCOVA|||||-6.4|-12.6|<0.001
73954995|NCT02696785|147444961|SUPERIORITY||LSMean Difference|-8.08|STANDARD_ERROR_OF_MEAN|1.603|<|0.001|TWO_SIDED|95.0|-11.2|-4.9|||ANCOVA|||||-4.9|-11.2|<0.001
73954996|NCT04672460|147444992|OTHER||Ratio (Test/Reference) of Adjusted Means|105.16|||||TWO_SIDED|90.0|99.0|111.7|||Mixed Models Analysis|||Treatment A were reference; treatment B were test.||111.70|99.00|
73954997|NCT04672460|147444993|OTHER||Ratio (Test/Reference) of Adjusted Means|136.62|||||TWO_SIDED|90.0|125.05|149.27|||Mixed Models Analysis|||Treatment A were reference; treatment B were test.||149.27|125.05|
73954998|NCT04672460|147444994|OTHER||Ratio (Test/Reference) of Adjusted Means|87.97|||||TWO_SIDED|90.0|81.82|94.58|||Mixed Models Analysis|||Treatment B were reference; treatment C were test.||94.58|81.82|
73954999|NCT04672460|147444995|OTHER||Ratio (Test/Reference) of Adjusted Means|58.26|||||TWO_SIDED|90.0|51.55|65.84|||Mixed Models Analysis|||Treatment B were reference; treatment C were test.||65.84|51.55|
73955000|NCT03575962|147445003|OTHER||Ratio of geometric least square mean|1.1169|||||TWO_SIDED|90.0|0.99|1.27||||||||1.27|0.99|
73955001|NCT03575962|147445004|OTHER||Ratio of geometric least square mean|1.1556|||||TWO_SIDED|90.0|0.99|1.35||||||||1.35|0.99|
73955002|NCT04541186|147445086|SUPERIORITY||Median Percent Change Difference|-43.73|||<|0.001|TWO_SIDED|95.0|-57.08|-30.31||Significant level = 0.05|van Elteren test|Nonparametric analysis stratified by baseline TG level and background lipid therapy to test the treatment difference using pooled data.|The location shift and Hodges-Lehmann 95% confidence interval were based on Hodges-Lehman estimation. Placebo group is the reference group, and the comparison was performed in pooled pegozafermin treatment group vs. placebo pooled.|||-30.31|-57.08|<0.001
73955003|NCT04541186|147445087|SUPERIORITY||||||<|0.001||||||Significant level = 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline TG level and lipid modifying therapy use.||||||<0.001
73955004|NCT04541186|147445088|SUPERIORITY||Least Squares Means Difference|-17.87|STANDARD_ERROR_OF_MEAN|6.425||0.007|TWO_SIDED|95.0|-30.67|-5.07||Significant level = 0.05|MMRM|||MMRM analysis of non-HDL-C comparison between pegozafermin pooled versus placebo pooled group.||-5.07|-30.67|0.007
74009168|NCT00617604|147569099|SUPERIORITY_OR_OTHER||Difference|1.9|||||TWO_SIDED|90.0|-1.3|5.0||||||||5.0|-1.3|
74009169|NCT00617604|147569100|SUPERIORITY_OR_OTHER||Difference|4.6|||||TWO_SIDED|90.0|-1.2|10.4||||||||10.4|-1.2|
74009170|NCT00617604|147569102|SUPERIORITY_OR_OTHER||Difference|2.0|||||TWO_SIDED|90.0|-3.3|7.2||||||||7.2|-3.3|
74009171|NCT00617604|147569107|SUPERIORITY_OR_OTHER||Slope|6.0|||||TWO_SIDED|90.0|-2.7|14.6||||||||14.6|-2.7|
74009172|NCT00617604|147569108|SUPERIORITY_OR_OTHER||Difference|-4.5|||||TWO_SIDED|90.0|-11.2|2.2||||||||2.2|-11.2|
74009173|NCT00617604|147569109|SUPERIORITY_OR_OTHER||Difference|5.2|||||TWO_SIDED|90.0|-4.4|14.7||||||||14.7|-4.4|
74039502|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0044|TWO_SIDED|95.0|-0.23|-0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.23|0.0044
73955005|NCT04541186|147445088|SUPERIORITY||Least Squares Means Difference|-11.75|STANDARD_ERROR_OF_MEAN|4.888||0.019|TWO_SIDED|95.0|-21.48|-2.01||Significant level of 0.05|MMRM|||MMRM analysis of ApoB comparison between pegozafermin pooled versus placebo pooled group.||-2.01|-21.48|0.019
73955006|NCT04541186|147445088|SUPERIORITY||Least Squares Means Difference|1.73|STANDARD_ERROR_OF_MEAN|10.519||0.87|TWO_SIDED|95.0|-19.21|22.68||Significant level = 0.05|MMRM|||MMRM analysis of LDL-C comparison between pegozafermin pooled versus placebo pooled group.||22.68|-19.21|0.870
73955007|NCT04541186|147445088|SUPERIORITY||Least Squares Means Difference|15.41|STANDARD_ERROR_OF_MEAN|8.182||0.064|TWO_SIDED|95.0|-0.89|31.7||Significant level = 0.05|MMRM|||MMRM analysis of HDL-C comparison between pegozafermin pooled versus placebo pooled group.||31.70|-0.89|0.064
73955008|NCT04541186|147445089|SUPERIORITY|||||||0.006||||||Significant level = 0.05|van Elteren Test|||Nonparametric analysis of VLDL-C comparison between pegozafermin pooled versus placebo pooled group.||||0.006
73955009|NCT04541186|147445089|SUPERIORITY|||||||0.002||||||Significant level of 0.05|van Elteren test|||Nonparametric analysis of VLDL-TG comparison between pegozafermin pooled versus placebo pooled group.||||0.002
73955010|NCT04541186|147445090|SUPERIORITY|||||||0.809||||||Significant level = 0.05|MMRM|||MMRM analysis of fasting plasma glucose comparison between pegozafermin pooled versus placebo pooled group.||||0.809
73955011|NCT04541186|147445090|SUPERIORITY||||||<|0.001||||||Significant level = 0.05|MMRM|||MMRM analysis of adiponectin comparison between pegozafermin pooled versus placebo pooled group.||||<0.001
73955012|NCT04541186|147445090|SUPERIORITY|||||||0.973||||||Significant level = 0.05|MMRM|||MMRM analysis of body weight comparison between pegozafermin pooled versus placebo pooled group.||||0.973
73955013|NCT04541186|147445091|SUPERIORITY|||||||0.012||||||Significant level = 0.05|ANCOVA|||||||0.012
73955014|NCT00058058|147445114|OTHER|Estimation of diagnostic yield|Binomial proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 based on Final BI-RADS||0.042|0.020|
73955015|NCT00058058|147445114|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.044||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up||0.044|0.021|
73955016|NCT00058058|147445114|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up and a completed biopsy procedure||0.042|0.020|
73955017|NCT00058058|147445114|OTHER||Binomial proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 on the initial MRI scan||0.042|0.020|
73955018|NCT00058058|147445114|OTHER||Binomial Proportion|0.032|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 on the initial MRI scan||0.043|0.021|
73955019|NCT00058058|147445114|OTHER||Binomial Proportion|0.032|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 based on initial MRI and subsequent work-up||0.043|0.021|
73955020|NCT00058058|147445115|OTHER||Binomial Proportion|0.9091|STANDARD_ERROR_OF_MEAN|0.05004|||TWO_SIDED|95.0|0.7567|0.9809||||||"Sensitivity estimate - estimates the P(T+\|D+) where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.9809|0.7567|
73955021|NCT00058058|147445115|OTHER||Binomial Proportion|0.8782|STANDARD_ERROR_OF_MEAN|0.0107|||TWO_SIDED|95.0|0.8555|0.8985||||||"Specificity - estimates the P(T-\|D-) of MRI where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.8985|0.8555|
73955022|NCT00058058|147445115|OTHER||Binomial Proportion|0.2083|STANDARD_ERROR_OF_MEAN|0.0338|||TWO_SIDED|95.0|0.1452|0.2839||||||"PPV estimate - estimates the P(D+\|T+), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)."||0.2839|0.1452|
73955023|NCT00058058|147445115|OTHER||Binomial Proportion|0.9964|STANDARD_ERROR_OF_MEAN|0.0021|||TWO_SIDED|95.0|0.9894|0.9993||||||"B. NPV Analysis for ALL Cases in Analysis Set NPV estimate - estimates the P(D-\|T-), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.9993|0.9894|
73955024|NCT00058058|147445115|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.00556|||TWO_SIDED|95.0|0.021|0.044||||||B. Diagnostic Yield for ALL Cases in Analysis Set Diagnostic Yield - estimates the likelihood that the MRI within 90 days of a negative mammogram will provide the information needed to establish a diagnosis||0.044|0.021|
73955025|NCT00058058|147445116|OTHER||ROC analysis|0.9355|||||TWO_SIDED|95.0|0.8956|0.9753|||||exact CI|ROC analysis - estimates the accuracy of MRI within 90 days of a negative mammogram to detect cancer in the contralateral breast||0.9753|0.8956|
73955026|NCT00790062|147445139|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.67|TWO_SIDED|95.0|0.63|1.59|||ANCOVA|||||1.59|0.63|0.670
73955027|NCT01360840|147445145|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||||TWO_SIDED|95.0|0.57|1.39||||||||1.39|0.57|
73955028|NCT01360840|147445145|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.52|1.26||||||||1.26|0.52|
73955029|NCT01360840|147445146|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|0.52|2.31||||||||2.31|0.52|
73955030|NCT01360840|147445146|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01|||||TWO_SIDED|95.0|0.47|2.15||||||||2.15|0.47|
73955031|NCT01360840|147445147|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91|||||TWO_SIDED|95.0|0.58|1.44||||||||1.44|0.58|
73955032|NCT01360840|147445147|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.52|1.27||||||||1.27|0.52|
73955033|NCT01813422|147445161|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-1.007|STANDARD_ERROR_OF_MEAN|0.187|<|0.0001|TWO_SIDED|95.0|-1.375|-0.64|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline PAV.|Treatment difference uses placebo as the reference.|||-0.640|-1.375|< 0.0001
73955034|NCT01813422|147445162|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-4.889|STANDARD_ERROR_OF_MEAN|1.201|<|0.0001|TWO_SIDED|95.0|-7.247|-2.531|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline TAV.|Treatment difference uses placebo as the reference.|||-2.531|-7.247|< 0.0001
73955035|NCT01813422|147445163|SUPERIORITY_OR_OTHER||Treatment Difference|17.0|||<|0.0001|TWO_SIDED|95.0|10.3|23.5|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.|||23.5|10.3|< 0.0001
73955036|NCT01813422|147445164|SUPERIORITY_OR_OTHER||Treatment Difference|12.5||||0.0002|TWO_SIDED|95.0|5.8|19.1|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.|||19.1|5.8|0.0002
73955037|NCT01112735|147445176|SUPERIORITY|||||||0.5621|||||||Wilcoxon (Mann-Whitney)|||||||0.5621
73955038|NCT01112735|147445177|SUPERIORITY|||||||0.3595|||||||Wilcoxon (Mann-Whitney)|||||||0.3595
73955039|NCT01112735|147445178|SUPERIORITY|||||||0.9417|||||||Wilcoxon (Mann-Whitney)|||Day 3||||0.9417
73955040|NCT01112735|147445178|SUPERIORITY|||||||0.5488|||||||Wilcoxon (Mann-Whitney)|||Day 7||||0.5488
73955041|NCT01112735|147445178|SUPERIORITY|||||||0.7107|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.7107
73955042|NCT01112735|147445178|SUPERIORITY|||||||0.8809|||||||Wilcoxon (Mann-Whitney)|||Day 28||||0.8809
73955043|NCT01112735|147445178|SUPERIORITY|||||||0.4598|||||||Wilcoxon (Mann-Whitney)|||Day 60||||0.4598
73955044|NCT01112735|147445178|SUPERIORITY|||||||0.3837|||||||Wilcoxon (Mann-Whitney)|||Day 90||||0.3837
73955045|NCT01112735|147445179|SUPERIORITY|||||||0.9699|||||||Wilcoxon (Mann-Whitney)|||Day 3||||0.9699
73955046|NCT01112735|147445179|SUPERIORITY|||||||0.4709|||||||Wilcoxon (Mann-Whitney)|||Day 7||||0.4709
73955047|NCT01112735|147445179|SUPERIORITY|||||||0.1406|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.1406
73955048|NCT01112735|147445179|SUPERIORITY|||||||0.4291|||||||Wilcoxon (Mann-Whitney)|||Day 28||||0.4291
73955049|NCT01112735|147445179|SUPERIORITY|||||||0.2704|||||||Wilcoxon (Mann-Whitney)|||Day 60||||0.2704
73955050|NCT01112735|147445179|SUPERIORITY|||||||0.7564|||||||Wilcoxon (Mann-Whitney)|||Day 90||||0.7564
73955051|NCT01872611|147445195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.2||0.671|TWO_SIDED|95.0|0.7|1.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.||1.3|0.7|0.671
73955052|NCT01872611|147445196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|0.2|0.7|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.||0.7|0.2|0.001
73955053|NCT03124108|147445201|SUPERIORITY||Difference in percentage|-52.0|STANDARD_ERROR_OF_MEAN|5.4|<|0.001|TWO_SIDED|95.0|-62.5|-41.5|||ANCOVA|||||-41.5|-62.5|<0.001
73955054|NCT03124108|147445201|SUPERIORITY||Difference in percentage|-43.9|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-55.7|-32.1|||ANCOVA|||||-32.1|-55.7|<0.001
73955055|NCT05096117|147445294|SUPERIORITY||Least Square Mean Difference|0.178||||0.784|TWO_SIDED||||||ANCOVA|||||||0.784
73955056|NCT00318656|147445321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.02|STANDARD_ERROR_OF_MEAN|2.49||0.064||95.0|-0.32|10.36|||ANCOVA|Analysis of covariance (ANCOVA)|Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.||10.36|-0.32|0.064
73955057|NCT00318656|147445322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|1.45||0.923||95.0|-3.37|2.85||P value von elteren (adjusted on sex)|ANCOVA||Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.||2.85|-3.37|0.923
73955058|NCT02806895|147445357|SUPERIORITY|||||||0.0062|||||||ANOVA|||||||0.0062
73955059|NCT02806895|147445358|SUPERIORITY|||||||0.0432|||||||ANOVA|||||||0.0432
73955060|NCT02806895|147445359|SUPERIORITY|||||||0.0414|||||||McNemar|||||||0.0414
73955061|NCT02806895|147445360|SUPERIORITY|||||||0.0963|||||||McNemar|||||||0.0963
73955062|NCT02806895|147445361|SUPERIORITY|||||||0.1435|||||||McNemar|||||||0.1435
73955063|NCT02806895|147445362|SUPERIORITY|||||||0.1796|||||||McNemar|||||||0.1796
73955064|NCT02806895|147445363|SUPERIORITY|||||||0.1094|||||||McNemar|||||||0.1094
73955065|NCT02806895|147445364|SUPERIORITY|||||||0.4531|||||||McNemar|||||||0.4531
73955066|NCT02806895|147445365|SUPERIORITY|||||||0.3593|||||||McNemar|||||||0.3593
73955067|NCT02806895|147445366|SUPERIORITY|||||||0.6072|||||||McNemar|||||||0.6072
73955068|NCT02806895|147445367|SUPERIORITY|||||||0.7905|||||||McNemar|||||||0.7905
73955069|NCT02806895|147445368|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
73955070|NCT02806895|147445369|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
73955071|NCT02806895|147445370|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
73955072|NCT02806895|147445371|SUPERIORITY|||||||0.4116|||||||ANOVA|||||||0.4116
73955073|NCT02806895|147445372|SUPERIORITY|||||||0.1991|||||||ANOVA|||||||0.1991
73955074|NCT02806895|147445373|SUPERIORITY|||||||0.0806|||||||ANOVA|||||||0.0806
73955075|NCT02806895|147445374|SUPERIORITY|||||||0.9391|||||||ANOVA|||||||0.9391
73955076|NCT02806895|147445375|SUPERIORITY|||||||0.2116|||||||ANOVA|||||||0.2116
73955077|NCT02806895|147445376|SUPERIORITY|||||||0.1604|||||||ANOVA|||||||0.1604
74033551|NCT00905307|147619888|SUPERIORITY_OR_OTHER||Relative risk|1.06||||0.854|TWO_SIDED|95.0|0.59|1.88||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.88|0.59|0.8540
74033552|NCT00905307|147619888|SUPERIORITY_OR_OTHER||Relative Risk|0.82||||0.4492|TWO_SIDED|95.0|0.49|1.38||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.38|0.49|0.4492
74033553|NCT00905307|147619888|SUPERIORITY_OR_OTHER||Relative Risk|0.67||||0.1854|TWO_SIDED|95.0|0.36|1.23||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.23|0.36|0.1854
74033554|NCT00905307|147619888|SUPERIORITY_OR_OTHER||Relative Risk|0.61||||0.0946|TWO_SIDED|95.0|0.33|1.1||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.10|0.33|0.0946
74033555|NCT00905307|147619888|SUPERIORITY_OR_OTHER||Relative Risk|0.63||||0.2133||95.0|0.3|1.34||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.34|0.30|0.2133
74033556|NCT00829166|147619923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.549|0.771|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or greater than \[\>\] 1), and visceral/ non-visceral disease.||0.771|0.549|<0.0001
73955078|NCT02806895|147445377|SUPERIORITY|||||||0.2144|||||||ANOVA|||||||0.2144
74033557|NCT00829166|147619925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.0006|TWO_SIDED|95.0|0.548|0.849|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.849|0.548|0.0006
74033558|NCT00829166|147619927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.749||||0.0003|TWO_SIDED|95.0|0.639|0.877|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.877|0.639|0.0003
74033559|NCT00829166|147619931|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.658|||<|0.0001|TWO_SIDED|95.0|0.56|0.774|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.774|0.560|<0.0001
74033560|NCT00829166|147619932|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|12.7||||0.0002|TWO_SIDED|95.0|6.0|19.4|||Mantel-Haenszel chi-squared test||The 95% CI for the difference in objective response rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the approximate normal method.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||19.4|6.0|0.0002
74033561|NCT00829166|147619934|SUPERIORITY_OR_OTHER||Difference in Clinical Benefit Rate|14.0|||||TWO_SIDED|95.0|7.0|20.9|||||The 95% CI for the difference in clinical benefit rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the normal approximation method.|||20.9|7.0|
73955079|NCT02806895|147445378|SUPERIORITY|||||||0.0387|||||||ANOVA|||||||0.0387
73955080|NCT02806895|147445379|SUPERIORITY|||||||0.3426|||||||ANOVA|||||||0.3426
73955081|NCT02806895|147445380|SUPERIORITY|||||||0.1531|||||||ANOVA|||||||0.1531
73955082|NCT02806895|147445381|SUPERIORITY|||||||0.5603|||||||ANOVA|||||||0.5603
73955083|NCT02806895|147445382|SUPERIORITY|||||||0.4851|||||||ANOVA|||||||0.4851
73955084|NCT02806895|147445383|SUPERIORITY|||||||0.0241|||||||ANOVA|||||||0.0241
73955085|NCT02042443|147445384|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.05|TWO_SIDED|95.0|1.01|4.03|||Log Rank|||||4.03|1.01|0.05
73955086|NCT02735187|147445388|SUPERIORITY|A paired t-test was applied to test the primary hypothesis. In case the requirements for normality were not met, a non-parametric analysis (Wilcoxon signed rank test) was performed.||||||0.6469||||||A probability (P-Value) above 0.05 is considered not to be statistical significant.|t-test, 2 sided|||||||0.6469
73955087|NCT05750745|147445423|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.0871|TWO_SIDED|95.0|-0.36|0.02|||Mixed Model with Repeated Measure (MMRM)||Adjusted mean difference was calculated as test minus negative control.|||0.02|-0.36|0.0871
73955088|NCT05750745|147445424|SUPERIORITY||Adjusted Mean Difference|6.21|STANDARD_ERROR_OF_MEAN|3.548||0.0972|TWO_SIDED|95.0|-0.78|13.2|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as test minus negative control.|||13.20|-0.78|0.0972
73955089|NCT05750745|147445425|SUPERIORITY||Adjusted Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|3.16||0.0671|TWO_SIDED|95.0|-12.04|0.41|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||0.41|-12.04|0.0671
73955090|NCT05750745|147445426|SUPERIORITY||Adjusted Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.0673|TWO_SIDED|95.0|-0.27|0.01|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||0.01|-0.27|0.0673
73955091|NCT05750745|147445427|SUPERIORITY||Adjusted Mean Difference|2.38|STANDARD_ERROR_OF_MEAN|2.446||0.405|TWO_SIDED|95.0|-2.44|7.2|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as test minus negative control.|||7.20|-2.44|0.4050
73955092|NCT05750745|147445428|SUPERIORITY||Adjusted Mean Difference|-5.64|STANDARD_ERROR_OF_MEAN|2.656||0.0346|TWO_SIDED|95.0|-10.88|-0.41|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||-0.41|-10.88|0.0346
73955093|NCT05750745|147445429|SUPERIORITY||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.085||0.8256|TWO_SIDED|95.0|-0.15|0.19|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||0.19|-0.15|0.8256
74033562|NCT00829166|147619936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.703|||<|0.0001|TWO_SIDED|95.0|0.602|0.82|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.820|0.602|<0.0001
73955094|NCT05750745|147445429|SUPERIORITY||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.117||0.5314|TWO_SIDED|95.0|-0.16|0.3|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||0.30|-0.16|0.5314
73955095|NCT05750745|147445430|SUPERIORITY||Adjusted Mean Difference|-2.59|STANDARD_ERROR_OF_MEAN|2.99||0.5575|TWO_SIDED|95.0|-8.48|3.3|||van Elteren Test|P-value was from the Van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||3.30|-8.48|0.5575
73955096|NCT05750745|147445430|SUPERIORITY||Adjusted Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|4.308||0.7717|TWO_SIDED|95.0|-9.6|7.37|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||7.37|-9.60|0.7717
73955097|NCT05750745|147445431|SUPERIORITY||Adjusted Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|3.235||0.818|TWO_SIDED|95.0|-5.63|7.12|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||7.12|-5.63|0.8180
73955098|NCT05750745|147445431|SUPERIORITY||Adjusted Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|3.834||0.3322|TWO_SIDED|95.0|-3.83|11.28|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||11.28|-3.83|0.3322
73955099|NCT00783692|147445445|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.8||||0.0206|TWO_SIDED|95.0|1.2|14.3||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.||14.3|1.2|0.0206
73955100|NCT00783692|147445446|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.7||||0.2322|TWO_SIDED|95.0|-3.6|15.0||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.||15.0|-3.6|0.2322
73955101|NCT00783692|147445447|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.4||||0.0007|TWO_SIDED|95.0|7.3|27.5||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||27.5|7.3|0.0007
73955102|NCT00783692|147445447|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.7||||0.0042|TWO_SIDED|95.0|4.6|24.7||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||24.7|4.6|0.0042
73955103|NCT00783692|147445448|SUPERIORITY_OR_OTHER|||||||0.9288||||||Wilcoxon Rank Sum test on the CRP change from baseline values (two-sided).|Wilcoxon (Mann-Whitney)|||If at least 1 of the primary endpoints was significant, the sequential Hochberg procedure was to be used to test the secondary endpoint for significance at the 0.05% level.||||0.9288
73981692|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.17|||||TWO_SIDED|95.0|0.87|1.57|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)||1.57|0.87|
74033563|NCT00829166|147619938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.0121|TWO_SIDED|95.0|0.667|0.951|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.951|0.667|0.0121
73981693|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.88|||||TWO_SIDED|95.0|0.73|1.07|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)||1.07|0.73|
74033564|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|1.8|||||TWO_SIDED|90.0|-0.4|4.1||||||1 hour postdose||4.1|-0.4|
73981694|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.91|||||TWO_SIDED|95.0|0.7|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.70|
73981695|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97|||||TWO_SIDED|95.0|0.79|1.18|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)||1.18|0.79|
73981696|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.71|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.71|
73981697|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.04|||||TWO_SIDED|95.0|0.8|1.36|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)||1.36|0.80|
73981698|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|329.44|||||TWO_SIDED|95.0|242.98|446.67|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)||446.67|242.98|
73981699|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|40.79|||||TWO_SIDED|95.0|30.27|54.97|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)||54.97|30.27|
73981700|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|13.12|||||TWO_SIDED|95.0|9.92|17.34|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)||17.34|9.92|
74033565|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|2.7|||||TWO_SIDED|90.0|0.4|4.9||||||1.5 hours postdose||4.9|0.4|
73981701|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|9.01|||||TWO_SIDED|95.0|6.46|12.56|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)||12.56|6.46|
73981702|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|165.9|||||TWO_SIDED|95.0|122.95|223.85|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)||223.85|122.95|
73981703|NCT00689351|147508758|SUPERIORITY_OR_OTHER||Ratio of geometric means|2.24|||||TWO_SIDED|95.0|1.83|2.75|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)||2.75|1.83|
73981704|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.78|||||TWO_SIDED|95.0|0.6|1.02|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)||1.02|0.60|
74033566|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|2.1|||||TWO_SIDED|90.0|-0.1|4.4||||||2 hours postdose||4.4|-0.1|
74033567|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|-0.5|||||TWO_SIDED|90.0|-2.8|1.7||||||3 hours postdose||1.7|-2.8|
74033568|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|-4.1|||||TWO_SIDED|90.0|-6.3|-1.8||||||4 hours postdose||-1.8|-6.3|
74033569|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|-3.5|||||TWO_SIDED|90.0|-5.7|-1.2||||||6 hours postdose||-1.2|-5.7|
74033570|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|-4.9|||||TWO_SIDED|90.0|-7.1|-2.6||||||12 hours postdose||-2.6|-7.1|
74033571|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|-0.9|||||TWO_SIDED|90.0|-3.1|1.4||||||24 hours postdose||1.4|-3.1|
74033572|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|0.9|||||TWO_SIDED|90.0|-1.4|3.1||||||1 hour postdose||3.1|-1.4|
74033573|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|2.0|||||TWO_SIDED|90.0|-0.2|4.2||||||1.5 hours postdose||4.2|-0.2|
73955104|NCT00783692|147445449|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.4||||0.0132|TWO_SIDED|95.0|2.8|24.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||24.0|2.8|0.0132
73955105|NCT00783692|147445449|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.3||||0.0053|TWO_SIDED|95.0|4.6|26.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||26.0|4.6|0.0053
73955106|NCT00783692|147445450|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.9||||0.0154|TWO_SIDED|95.0|3.0|28.7||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||28.7|3.0|0.0154
73955107|NCT00783692|147445450|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.9||||0.045|TWO_SIDED|95.0|0.3|25.5||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||25.5|0.3|0.0450
73955108|NCT00783692|147445451|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.2||||0.1036|TWO_SIDED|95.0|-1.5|16.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||16.0|-1.5|0.1036
73955109|NCT00783692|147445451|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.0||||0.6413|TWO_SIDED|95.0|-6.3|10.2||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||10.2|-6.3|0.6413
73955110|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 1.|Student's t-test|||||||<0.0001
73955111|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 14.|Student's t-test|||||||<0.0001
73955112|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 31.|Student's t-test|||||||<0.0001
73955113|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 10.|Student's t-test|||||||<0.0001
73955114|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 18.|Student's t-test|||||||<0.0001
73955115|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 26.|Student's t-test|||||||<0.0001
73955116|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 34.|Student's t-test|||||||<0.0001
73955117|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 42.|Student's t-test|||||||<0.0001
74033574|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|0.9|||||TWO_SIDED|90.0|-1.4|3.1||||||2 hours postdose||3.1|-1.4|
74033575|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|-1.6|||||TWO_SIDED|90.0|-3.8|0.7||||||3 hours postdose||0.7|-3.8|
73981705|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.11|||||TWO_SIDED|95.0|0.83|1.48|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)||1.48|0.83|
73981706|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.95|||||TWO_SIDED|95.0|0.76|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.76|
73981707|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.74|||||TWO_SIDED|95.0|0.57|0.95|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)||0.95|0.57|
73981708|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.72|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.72|
73981709|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.45|||||TWO_SIDED|95.0|1.11|1.88|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)||1.88|1.11|
73981710|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.78|1.4|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)||1.40|0.78|
74009174|NCT02303704|147569150|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means|||||<|0.05|TWO_SIDED|||||P-value less than 0.05 was considered significant|t-test, 2 sided|two compare two independent quantitative groups||Null hypothesis was there is no significant difference between the means of two groups||||<0.05
73955118|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 50.|Student's t-test|||||||<0.0001
73955119|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 58.|Student's t-test|||||||<0.0001
73955120|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 70.|Student's t-test|||||||<0.0001
73955121|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 82.|Student's t-test|||||||<0.0001
73955122|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 94.|Student's t-test|||||||<0.0001
73955123|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 106.|Student's t-test|||||||<0.0001
73955124|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 118.|Student's t-test|||||||<0.0001
73955125|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 130.|Student's t-test|||||||<0.0001
73955126|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 142.|Student's t-test|||||||<0.0001
73955127|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 154.|Student's t-test|||||||<0.0001
73955128|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 166.|Student's t-test|||||||<0.0001
73955129|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 178.|Student's t-test|||||||<0.0001
73955130|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 190.|Student's t-test|||||||<0.0001
73955131|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 202.|Student's t-test|||||||<0.0001
73955132|NCT02449044|147445478|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 214.|Student's t-test|||||||<0.0001
73955133|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.4922|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.4922
73955134|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.1054|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.1054
73955135|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.7656|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.7656
73955136|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.7084|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.7084
73955137|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.5138|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.5138
73955138|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.7175|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.7175
73955139|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.354|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.3540
73955140|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.0852|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.0852
74033576|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|-3.7|||||TWO_SIDED|90.0|-5.9|-1.5||||||4 hours postdose||-1.5|-5.9|
74033577|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|-2.3|||||TWO_SIDED|90.0|-4.6|-0.1||||||6 hours postdose||-0.1|-4.6|
73955141|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.1923|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.1923
73955142|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.2335|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.2335
73955143|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.1346|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.1346
73955144|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.5237|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.5237
73955145|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.3476|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 118||||0.3476
73955146|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.2488|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 130||||0.2488
73955147|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.1598|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.1598
73955148|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.282|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 154||||0.2820
73955149|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.3743|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.3743
73955150|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.3600
73955151|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.3101|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.3101
73955152|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 202||||0.0269
73955153|NCT02449044|147445485|SUPERIORITY_OR_OTHER|||||||0.0944|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.0944
73955154|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.1739|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14||||0.1739
73955155|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.6095|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.6095
73955156|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.6902|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.6902
73955157|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.634|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.6340
73955158|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.321|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.3210
73955159|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.7787|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.7787
73955160|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.2198|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.2198
73955161|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.1926|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.1926
73955162|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.3109|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.3109
73955163|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.2269|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.2269
73955164|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.2749
73955165|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.0702|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.0702
73955166|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.0412|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.0412
73955167|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.4448|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.4448
74033578|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|-5.1|||||TWO_SIDED|90.0|-7.3|-2.8||||||12 hours postdose||-2.8|-7.3|
74033579|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|-0.2|||||TWO_SIDED|90.0|-2.4|2.1||||||24 hours postdose||2.1|-2.4|
74033580|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|10.8|||||TWO_SIDED|98.0|7.6|14.0||||||1 hour postdose||14.0|7.6|
74033581|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|10.2|||||TWO_SIDED|98.0|7.0|13.4||||||1.5 hours postdose||13.4|7.0|
74033582|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|11.2|||||TWO_SIDED|98.0|8.0|14.4||||||2 hours postdose||14.4|8.0|
74033583|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|11.5|||||TWO_SIDED|98.0|8.3|14.7||||||3 hours postdose||14.7|8.3|
74033584|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|9.7|||||TWO_SIDED|98.0|6.5|12.8||||||4 hours postdose||12.8|6.5|
73955168|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.6233|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.6233
73955169|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.1001|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.1001
73955170|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.3739|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.3739
73981711|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|234.33|||||TWO_SIDED|95.0|176.33|311.41|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)||311.41|176.33|
73981712|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|16.63|||||TWO_SIDED|95.0|12.19|22.69|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)||22.69|12.19|
74033585|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|10.4|||||TWO_SIDED|98.0|7.2|13.5||||||6 hours postdose||13.5|7.2|
74033586|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|7.3|||||TWO_SIDED|98.0|4.1|10.4||||||12 hours postdose||10.4|4.1|
73955171|NCT02449044|147445486|SUPERIORITY_OR_OTHER|||||||0.3334|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.3334
73955172|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.2575|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14||||0.2575
73955173|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.2715|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.2715
73981713|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|6.84|||||TWO_SIDED|95.0|5.39|8.67|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)||8.67|5.39|
73981714|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|4.08|||||TWO_SIDED|95.0|3.07|5.43|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)||5.43|3.07|
73955174|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.686|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.6860
73955175|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.0224|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.0224
73981715|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|110.92|||||TWO_SIDED|95.0|77.09|159.59|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)||159.59|77.09|
73981716|NCT00689351|147508759|SUPERIORITY_OR_OTHER||Ratio of geometric means|4.25|||||TWO_SIDED|95.0|3.39|5.33|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)||5.33|3.39|
73955176|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.1871|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.1871
73955177|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.0039
73955178|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.0325|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.0325
74033587|NCT03510663|147619942|SUPERIORITY||Least Squares Mean Difference|7.0|||||TWO_SIDED|98.0|3.8|10.2||||||24 hours postdose||10.2|3.8|
74033588|NCT04743635|147619955|OTHER|"Performance goal.~Hypothesis:~Ho: D \< 1 Ha: D ≥ 1, where D = reduction in the CSS score from baseline to 3 months, and 1 is the performance goal. If the lower bound of the two-sided 95% confidence interval is greater than or equal to 1 then we will reject the null hypothesis and conclude the device performs effectively."|Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|0.9||0.0001|TWO_SIDED|95.0|1.28|1.71|||t-test, 2 sided|The 2-sided 95% confidence interval for the mean reduction in CSS was calculated along with the corresponding p-value (Student's t-test).||The endpoint tested the mean of the changes for each treated participant, not a 1-point change between mean score of the group at baseline versus 3 months. Success is achieved when the mean change across all treated participants is at least one point.||1.71|1.28|.0001
74033589|NCT04743635|147619956|OTHER|Performance goal. The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6.|Percentage improved|95.6||||0.0001|TWO_SIDED|95.0|87.6|99.1|||t-test, 2 sided|||"The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted (e.g., if improved, worse and much worse, worse was counted). A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3)."||99.1|87.6|.0001
73955179|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.0631|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.0631
73873867|NCT00286429|147289631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.72|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size \>=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and \>=80% of subjects meeting the per protocol criteria.||-0.30|-0.72|<0.001
73955180|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.0277|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.0277
73955181|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.0128|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.0128
73955182|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.0164|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.0164
73955183|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.0119|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.0119
73955184|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.0013
73955185|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.6691|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.6691
73955186|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.6923|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.6923
73955187|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.9292|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.9292
73955188|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.4401|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.4401
73955189|NCT02449044|147445487|SUPERIORITY_OR_OTHER|||||||0.3609|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.3609
73955190|NCT02857283|147445519|SUPERIORITY|||||||0.46|||||||ANOVA|paired||||||0.46
73955191|NCT02857283|147445520|SUPERIORITY|||||||0.0481|||||||ANOVA|Paired||||||0.0481
73955192|NCT02857283|147445521|SUPERIORITY|||||||0.0179|||||||ANOVA|||||||0.0179
73955193|NCT02857283|147445522|SUPERIORITY|||||||0.1|||||||ANOVA|paired||||||0.10
73955194|NCT02857283|147445523|SUPERIORITY|||||||0.69|||||||ANOVA|paired||||||0.69
73955195|NCT02857283|147445524|SUPERIORITY|||||||0.27|||||||ANOVA|paired||||||0.27
73955196|NCT02857283|147445525|SUPERIORITY|||||||0.5|||||||ANOVA|paired||||||0.50
73955197|NCT02857283|147445526|SUPERIORITY|||||||0.54|||||||Wilcoxon signed rank test|||||||0.54
73955198|NCT02857283|147445527|SUPERIORITY|||||||0.9|||||||ANOVA|paired||||||0.90
73955199|NCT02857283|147445529|SUPERIORITY|||||||0.64|||||||Wilcoxon signed rank test|||||||0.64
73955200|NCT02857283|147445530|SUPERIORITY|||||||0.79|||||||Wilcoxon signed rank test|||||||0.79
73955201|NCT02857283|147445531|SUPERIORITY|||||||0.094|||||||ANOVA|||||||0.094
73955202|NCT00587288|147445532|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.194||0.0541|TWO_SIDED|95.0|-0.76|0.01||The p-value for the treatment comparison is based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||0.01|-0.76|0.0541
73955203|NCT00587288|147445533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0848|TWO_SIDED|95.0|0.91|4.46||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic|||||4.46|0.91|0.0848
73955204|NCT00587288|147445534|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.077||0.0023|TWO_SIDED|95.0|0.088|0.392||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||0.392|0.088|0.0023
73955205|NCT00587288|147445535|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.98|STANDARD_ERROR_OF_MEAN|2.36||0.001|TWO_SIDED|95.0|3.3|12.65||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||12.65|3.30|0.0010
73955206|NCT00587288|147445536|SUPERIORITY_OR_OTHER||Adjusted mean difference|-125.29|STANDARD_ERROR_OF_MEAN|44.885||0.0068|TWO_SIDED|95.0|-214.81|-35.77||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline. The difference between reslizumab 3.0 mg/kg and placebo groups was from comparison of the least square means.|ANCOVA|||||-35.77|-214.81|0.0068
73955207|NCT00587288|147445537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.0833|TWO_SIDED|95.0|0.1|1.15||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic|||||1.15|0.10|0.0833
73981717|NCT00689351|147508760|SUPERIORITY_OR_OTHER|||||||0.862|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.862
73981718|NCT00689351|147508760|SUPERIORITY_OR_OTHER|||||||0.157|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.157
73981719|NCT00689351|147508760|SUPERIORITY_OR_OTHER|||||||0.55|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.550
73873868|NCT00286429|147289631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size \>=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and \>=80% of subjects meeting the per protocol criteria.||-0.37|-0.80|<0.001
73873869|NCT00286429|147289632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001|TWO_SIDED|95.0|-0.34|-0.09||No multiplicity adjustments|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.09|-0.34|<0.001
73873870|NCT00286429|147289632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.45|-0.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.20|-0.45|<0.001
73873871|NCT00286429|147289633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.31||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.31|-0.65|<0.001
73873872|NCT00286429|147289633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.39|-0.73|<0.001
73873873|NCT00286429|147289634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.77|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.77|<0.001
73873874|NCT00286429|147289634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.34|-0.75|<0.001
73873875|NCT00286429|147289635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.79|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.79|<0.001
73981720|NCT00689351|147508760|SUPERIORITY_OR_OTHER|||||||0.052|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.052
73981721|NCT00689351|147508760|SUPERIORITY_OR_OTHER|||||||0.366|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.366
73981722|NCT00689351|147508760|SUPERIORITY_OR_OTHER|||||||0.301|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.301
73981723|NCT00689351|147508760|SUPERIORITY_OR_OTHER|||||||0.362|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.362
73981724|NCT00689351|147508760|SUPERIORITY_OR_OTHER|||||||0.718|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.718
73981725|NCT00689351|147508761|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||>0.99
73981726|NCT00689351|147508761|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.245
73981727|NCT00689351|147508761|SUPERIORITY_OR_OTHER|||||||0.447|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.447
73981728|NCT00689351|147508761|SUPERIORITY_OR_OTHER|||||||0.684|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.684
73981729|NCT00689351|147508761|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||>0.99
73981730|NCT00689351|147508761|SUPERIORITY_OR_OTHER|||||||0.578|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.578
73981731|NCT00689351|147508761|SUPERIORITY_OR_OTHER|||||||0.451|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.451
73981732|NCT00689351|147508761|SUPERIORITY_OR_OTHER|||||||0.712|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.712
73981733|NCT00689351|147508762|SUPERIORITY_OR_OTHER|||||||0.681|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.681
73981734|NCT00689351|147508762|SUPERIORITY_OR_OTHER|||||||0.482|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.482
73981735|NCT00689351|147508762|SUPERIORITY_OR_OTHER|||||||0.683|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.683
73981736|NCT00689351|147508762|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||>0.99
73981737|NCT00689351|147508762|SUPERIORITY_OR_OTHER|||||||0.533|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.533
73981738|NCT00689351|147508762|SUPERIORITY_OR_OTHER|||||||0.692|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.692
73981739|NCT00689351|147508762|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.662
73981740|NCT00689351|147508762|SUPERIORITY_OR_OTHER|||||||0.331|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.331
73981741|NCT00689351|147508763|SUPERIORITY_OR_OTHER|||||||0.409|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.409
73981742|NCT00689351|147508763|SUPERIORITY_OR_OTHER|||||||0.617|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.617
73981743|NCT00689351|147508763|SUPERIORITY_OR_OTHER|||||||0.807|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.807
73981744|NCT00689351|147508763|SUPERIORITY_OR_OTHER|||||||0.527|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.527
73981745|NCT00689351|147508763|SUPERIORITY_OR_OTHER|||||||0.144|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.144
73981746|NCT00689351|147508763|SUPERIORITY_OR_OTHER|||||||0.495|||||||Fisher Exact|||Comparison between treatments for severe swelling.||||0.495
73981747|NCT00689351|147508763|SUPERIORITY_OR_OTHER|||||||0.506|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.506
73981748|NCT00689351|147508763|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild redness.||||>0.99
73981749|NCT00689351|147508763|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.200
73981750|NCT00689351|147508764|SUPERIORITY_OR_OTHER|||||||0.633|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but but less than or equal to (≤)39 degrees C.||||0.633
73981751|NCT00689351|147508764|SUPERIORITY_OR_OTHER|||||||0.721|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.721
73981752|NCT00689351|147508764|SUPERIORITY_OR_OTHER|||||||0.009|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.009
73981753|NCT00689351|147508764|SUPERIORITY_OR_OTHER|||||||0.253|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.253
73981754|NCT00689351|147508764|SUPERIORITY_OR_OTHER|||||||0.143|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.143
73981755|NCT00689351|147508765|SUPERIORITY_OR_OTHER|||||||0.781|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.781
73981756|NCT00689351|147508765|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.060
73981757|NCT00689351|147508765|SUPERIORITY_OR_OTHER|||||||0.159|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.159
73981758|NCT00689351|147508765|SUPERIORITY_OR_OTHER|||||||0.839|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.839
73981759|NCT00689351|147508765|SUPERIORITY_OR_OTHER|||||||0.264|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.264
73981760|NCT00689351|147508766|SUPERIORITY_OR_OTHER|||||||0.563|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.563
73981761|NCT00689351|147508766|SUPERIORITY_OR_OTHER|||||||0.468|||||||Fisher Exact|||Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.||||0.468
73981762|NCT00689351|147508766|SUPERIORITY_OR_OTHER|||||||0.535|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.535
73981763|NCT00689351|147508766|SUPERIORITY_OR_OTHER|||||||0.019|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.019
73981764|NCT00689351|147508766|SUPERIORITY_OR_OTHER|||||||0.398|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.398
73981765|NCT00689351|147508766|SUPERIORITY_OR_OTHER|||||||0.125|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.125
73981766|NCT00689351|147508767|SUPERIORITY_OR_OTHER|||||||0.596|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.596
73981767|NCT00689351|147508767|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.||||>0.99
73981768|NCT00689351|147508767|SUPERIORITY_OR_OTHER|||||||0.663|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.663
73981769|NCT00689351|147508767|SUPERIORITY_OR_OTHER|||||||0.439|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.439
73981770|NCT00689351|147508767|SUPERIORITY_OR_OTHER|||||||0.613|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.613
73981771|NCT00689351|147508767|SUPERIORITY_OR_OTHER|||||||0.138|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.138
73981772|NCT02255474|147508772|SUPERIORITY||Mean Difference (Final Values)|-1.01|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons, treatment group p-value|Mixed Models Analysis|||Both eyes used in analysis adjusting for correlation.||||<0.01
73981773|NCT02255474|147508773|SUPERIORITY||quadratic coefficient|0.02||||0.05|TWO_SIDED||||||Mixed Models Analysis|||Individual subject eye length profiles were fit using quadratic equations as a function of gaze angle. The analysis of quadratic coefficients included treatment group, study year (categorical variable), and their interaction adjusted for age, study site, and ethnicity.||||0.05
73981774|NCT02255474|147508774|SUPERIORITY||regression coefficient|-0.12||||0.05|TWO_SIDED||||||Regression, Linear|Models control for age, sex, axial length at baseline, race, treatment group, treatment group by race interaction.||This analysis looks at the three-year change in spherical equivalent refractive error for different eccentricities of peripheral defocus measured with contact lenses in place||||0.05
73981775|NCT02255474|147508775|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.05|TWO_SIDED|||||Adjusted for multiple comparisons|Mixed Models Analysis|||Both eyes used in the analysis controlling for the correlation.||||0.05
73981776|NCT01082159|147508782|SUPERIORITY_OR_OTHER||change from baseline|3.59|STANDARD_DEVIATION|2.87|<|0.0001|TWO_SIDED|95.0|2.76|4.42|||t-test, 2 sided|||||4.42|2.76|<0.0001
73981777|NCT01082159|147508783|SUPERIORITY_OR_OTHER||Change from Baseline|12.17|STANDARD_DEVIATION|19.14|<|0.0001|TWO_SIDED|95.0|6.64|17.71|||t-test, 2 sided|||||17.71|6.64|<0.0001
73981778|NCT00882050|147508798|OTHER|||||||0.05|||||||Regression, Logistic|||logistic regression|Because we tested interventions against the placebo arm, we increased our subjects to overcome loss of power. 23 per group will provide 80% power assuming a reduced alpha of 0.01 to accommodate the multiple testing issues.|||0.05
73981779|NCT00882050|147508798|SUPERIORITY|Demographic data analyzed with nominal data tested by chi-square, ordinal data by Mann-Whitney, and normal data by t-test. Further, a linear regression analysis to determine the effect of intervention dose on glucose level and typical confounders such as age, weight, and type of surgery was completed. Adverse and SAEs were analyzed by chi-square for occurrence.||||||0.05||||||Due to have 3 trial groups our p value was adjusted for multiple comparisons as a a priori threshold (if a single comparison) was 0.05.|Regression, Logistic|The regression (see above) is a secondary analysis. Groups had been stratified on diabetic (y/n) to balance this potential confounder||Primary t tests of glucose between the 3 groups at 90 minutes post. Secondary MANOVA to determine the effect over time. Change in mean glucose of 20 mg/dl between all groups detectable by 18 subjects per group assuming a SD of 20mg/dl., an 82% power with an alpha of 0.05. Because we tested interventions against the placebo arm, we increased our subjects to overcome loss of power. 23 per group will provide 80% power assuming a reduced alpha of 0.01 to accommodate the multiple testing issues.||||0.05
73981780|NCT02367794|147508799|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0006|TWO_SIDED|95.0|0.64|0.88|||Log Rank|||||0.88|0.64|0.0006
73981781|NCT02367794|147508800|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1581|TWO_SIDED|95.0|0.73|1.05|||Log Rank|||||1.05|0.73|0.1581
73981782|NCT02367794|147508801|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.876||||0.4451|TWO_SIDED|95.0|0.623|1.231|||Log Rank|||Teff \>=-1.91 in ITT||1.231|0.623|0.4451
73981783|NCT02367794|147508801|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.941||||0.7343|TWO_SIDED|95.0|0.664|1.335|||Log Rank|||Teff \>=-1.91 in ITT||1.335|0.664|0.7343
73981784|NCT02367794|147508801|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.942||||0.661|TWO_SIDED|95.0|0.72|1.232|||Log Rank|||Teff \<-1.91 Negative in ITT||1.232|0.720|0.6610
73981785|NCT02367794|147508801|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.253||||0.0893|TWO_SIDED|95.0|0.965|1.627|||Log Rank|||Teff \<-1.91 Negative in ITT||1.627|0.965|0.0893
73981786|NCT02367794|147508802|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.61||||0.0006|TWO_SIDED|95.0|0.46|0.81|||Log Rank|||Teff\>=-1.91||0.81|0.46|0.0006
73981787|NCT02367794|147508802|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.06||||0.63|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Teff\>=-1.91||1.33|0.84|0.630
73981788|NCT02367794|147508802|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.88||||0.258|TWO_SIDED|95.0|0.7|1.1|||Log Rank|||Teff\<-1.91||1.10|0.70|0.258
73981789|NCT02367794|147508802|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.06||||0.63|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Teff\<-1.91||1.33|0.84|0.630
73981790|NCT02367794|147508803|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.4|0.72|||Log Rank|||||0.72|0.40|<.0001
73981791|NCT02367794|147508803|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61||||0.0018|TWO_SIDED|95.0|0.45|0.84|||Log Rank|||||0.84|0.45|0.0018
73981792|NCT02367794|147508804|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.48|0.77|||Log Rank|||||0.77|0.48|<.0001
73981793|NCT02367794|147508804|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.48|0.77|||Log Rank|||||0.77|0.48|<.0001
73981794|NCT02367794|147508805|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.725||||0.0518|TWO_SIDED|95.0|0.524|1.004|||Log Rank|||||1.004|0.524|0.0518
73981795|NCT02367794|147508805|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.832||||0.2841|TWO_SIDED|95.0|0.594|1.165|||Log Rank|||||1.165|0.594|0.2841
73981796|NCT02367794|147508806|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.871||||0.2956|TWO_SIDED|95.0|0.671|1.129|||Log Rank|||||1.129|0.671|0.2956
73981797|NCT02367794|147508806|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.861||||0.2473|TWO_SIDED|95.0|0.668|1.109|||Log Rank|||||1.109|0.668|0.2473
73981798|NCT02367794|147508807|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.0248|TWO_SIDED|95.0|1.04|1.91|||Cochran-Mantel-Haenszel|||||1.91|1.04|0.0248
73981799|NCT02367794|147508807|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.4||||0.0308|TWO_SIDED|95.0|1.03|1.9|||Cochran-Mantel-Haenszel|||||1.90|1.03|0.0308
73981800|NCT02367794|147508808|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.408|0.689|||Log Rank|||||0.689|0.408|<.0001
73981801|NCT02367794|147508808|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.64||||0.0007|TWO_SIDED|95.0|0.493|0.831|||Log Rank|||||0.831|0.493|0.0007
73981802|NCT02367794|147508809|SUPERIORITY||Difference in Event Free Rate|0.06||||0.9871|TWO_SIDED|95.0|-7.48|7.61|||Z-test|||Event Free Rate (%) at Year 1||7.61|-7.48|0.9871
73981803|NCT02367794|147508809|SUPERIORITY||Difference in Event Free Rate|5.93||||0.1133|TWO_SIDED|95.0|-1.41|13.26|||Z-test|||Event Free Rate (%) at Year 2||13.26|-1.41|0.1133
73981804|NCT02367794|147508809|SUPERIORITY||Difference in Event Free Rate|-3.97||||0.3072|TWO_SIDED|95.0|-11.6|3.65|||Z-test|||Event Free Rate (%) at Year 1||3.65|-11.60|0.3072
73981805|NCT02367794|147508809|SUPERIORITY||Difference in Event Free Rate|1.21||||0.743|TWO_SIDED|95.0|-6.01|8.42|||Z-test|||Event Free Rate (%) at Year 2||8.42|-6.01|0.7430
73981806|NCT02367794|147508810|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.797||||0.0461|TWO_SIDED|95.0|0.638|0.996|||Log Rank|||||0.996|0.638|0.0461
73981807|NCT02367794|147508810|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.04||||0.7295|TWO_SIDED|95.0|0.834|1.296|||Log Rank|||||1.296|0.834|0.7295
73981808|NCT02367794|147508811|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.828||||0.0942|TWO_SIDED|95.0|0.663|1.033|||Log Rank|||||1.033|0.663|0.0942
73981809|NCT02367794|147508811|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.968||||0.7709|TWO_SIDED|95.0|0.776|1.207|||Log Rank|||||1.207|0.776|0.7709
73981810|NCT02367794|147508813|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.93||||0.4007|TWO_SIDED|95.0|0.784|1.102|||Log Rank|||||1.102|0.784|0.4007
73981811|NCT01020487|147508845|SUPERIORITY_OR_OTHER||Difference|27.8||||0.045|TWO_SIDED|95.0|7.5|52.8|||Fisher Exact|||Treatment effects were evaluated based on a two-sided significance level of 0.050. The primary efficacy analysis was a comparison between the paricalcitol capsules and placebo groups in the percentage of participants achieving 2 consecutive ≥ 30% reductions in iPTH from baseline regardless of CKD stage conducted using Fisher's exact test.||52.8|7.5|0.045
73981812|NCT01020487|147508846|SUPERIORITY_OR_OTHER|||||||0.128|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.128
73981813|NCT01020487|147508847|SUPERIORITY_OR_OTHER||Differenbce|-72.4|||<|0.001|TWO_SIDED|95.0|-108.05|-36.75|||Mixed Models Analysis|||Overall Comparison (all time points): A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-36.75|-108.05|< 0.001
73981814|NCT01020487|147508847|SUPERIORITY_OR_OTHER||Difference|-62.55||||0.006|TWO_SIDED|95.0|-105.6|-19.49|||Mixed Models Analysis|||Week 2 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-19.49|-105.60|0.006
73981815|NCT01020487|147508847|SUPERIORITY_OR_OTHER||Difference|-68.43||||0.032|TWO_SIDED|95.0|-130.39|-6.47|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-6.47|-130.39|0.032
73981816|NCT01020487|147508847|SUPERIORITY_OR_OTHER||Difference|-70.09||||0.043|TWO_SIDED|95.0|-137.82|-2.37|||Mixed Models Analysis|||Week 8 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-2.37|-137.82|0.043
73981817|NCT01020487|147508847|SUPERIORITY_OR_OTHER||Difference|-88.52||||0.002|TWO_SIDED|95.0|-142.04|-35.01|||Mixed Models Analysis|||Week 12 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-35.01|-142.04|0.002
73981818|NCT01020487|147508848|SUPERIORITY_OR_OTHER|||||||0.327|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.327
73981819|NCT01020487|147508849|SUPERIORITY_OR_OTHER|||||||0.194|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.194
73981820|NCT01020487|147508850|SUPERIORITY_OR_OTHER||Difference|0.14||||0.469|TWO_SIDED|95.0|-0.25|0.53|||Mixed Models Analysis|||Overall Comparison (all time points): a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||0.53|-0.25|0.469
73981821|NCT01020487|147508850|SUPERIORITY_OR_OTHER||Difference|-0.01||||0.975|TWO_SIDED|95.0|-0.39|0.37|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||0.37|-0.39|0.975
73981822|NCT01020487|147508850|SUPERIORITY_OR_OTHER||Difference|0.12||||0.567|TWO_SIDED|95.0|-0.32|0.56|||Mixed Models Analysis|||Week 8 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||0.56|-0.32|0.567
73981823|NCT01020487|147508850|SUPERIORITY_OR_OTHER||Difference|0.3||||0.462|TWO_SIDED|95.0|-0.53|1.12|||Mixed Models Analysis|||Week 12 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||1.12|-0.53|0.462
73981824|NCT01366976|147508851|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Mixed Models Analysis|||We hypothesized that acetaminophen would reduce peak isofuran concentrations by 22 pg/mL (40% reduction from peak concentrations). If the true difference in the acetaminophen and placebo group means is 22 pg/mL (SD=30 pg/mL), we would need to study 30 experimental subjects and 30 control subjects to be able to reject the null hypothesis that the population means of the acetaminophen and placebo groups are equal with probability (power) 0.8.||||0.05
73981825|NCT01366976|147508853|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
73981826|NCT01215253|147508878|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.117|TWO_SIDED|95.0|0.67|1.05|||Regression, Cox|||||1.05|0.67|0.117
73981827|NCT01215253|147508879|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.891|TWO_SIDED|95.0|0.76|1.26|||Regression, Cox|||||1.26|0.76|0.891
73981828|NCT01215253|147508880|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.028|TWO_SIDED|95.0|0.51|0.96|||Anderson-Gill analysis|||||0.96|0.51|0.028
73981829|NCT01215253|147508881|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.398|TWO_SIDED|95.0|0.38|1.47|||Regression, Cox|||||1.47|0.38|0.398
73981830|NCT01215253|147508882|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.316|TWO_SIDED|95.0|0.91|1.34|||Regression, Cox|||||1.34|0.91|0.316
73873876|NCT00286429|147289635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.33||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.33|-0.75|<0.001
73955208|NCT00587288|147445537|SUPERIORITY_OR_OTHER|||||||0.0809|||||||Log Rank|The p value for the treatment comparison was based on log rank test adjusting for stratification factor (ie, ACQ score ≤2 and \>2).||"Kaplan-Meier estimate of time to first CAE. (First quartile, median and third quartile survival times with 95% confidence intervals (ie, time to first CAE) could not be estimated since the proportion of patients experiencing CAE was too low. Therefore, the only number presented in regard to the Kaplan-Meier analysis is the p-value of the log-rank test, below. )"||||0.0809
73955209|NCT01207908|147445539|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.53|TWO_SIDED|95.0|-37.1|20.1|||t-test, 2 sided|||||20.1|-37.1|0.53
73955210|NCT01207908|147445540|SUPERIORITY||Mean Difference (Final Values)|-2.66|||<|0.0001|TWO_SIDED|95.0|-3.78|-1.55|||t-test, 2 sided|||||-1.55|-3.78|<0.0001
73955211|NCT01207908|147445541|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.53|TWO_SIDED|95.0|-1.26|2.38|||t-test, 2 sided|||||2.38|-1.26|0.53
73955212|NCT05074498|147445582|OTHER||Least square mean difference|-0.35||||0.0838|TWO_SIDED|95.0|-0.741|0.047|||Mixed Models Analysis|||||0.047|-0.741|0.0838
73955213|NCT02967016|147445622|OTHER|||||||0.002|||||||Kruskal-Wallis|||Cumulative Steps 6 h||||0.002
73955214|NCT02967016|147445622|OTHER|||||||0.0002|||||||Kruskal-Wallis|||Cumulative steps 12 h||||.0002
74033590|NCT04743635|147619959|OTHER|Performance goal. In order to meet the endpoint, the lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.|Percentage improved|72.1||||0.0264|TWO_SIDED|95.0|59.9|82.3|||t-test, 2 sided|||||82.3|59.9|.0264
73955215|NCT02967016|147445622|OTHER|||||||0.0006|||||||Kruskal-Wallis|||Cumulative steps 24 h||||.0006
73955216|NCT02967016|147445622|OTHER|||||||0.0006|||||||Kruskal-Wallis|||Cumulative steps 36 h||||0.0006
73955217|NCT02967016|147445622|OTHER|||||||0.03|||||||Kruskal-Wallis|||Cumulative steps 48 h||||0.03
73955218|NCT02967016|147445623|OTHER|||||||0.06|||||||Kruskal-Wallis|||Pain at rest 6 h||||0.06
73955219|NCT02967016|147445623|OTHER|||||||0.3|||||||Kruskal-Wallis|||Pain at rest 12 h||||.30
73955220|NCT02967016|147445623|OTHER|||||||0.002|||||||Kruskal-Wallis|||Pain at rest 24 h||||.002
73955221|NCT02967016|147445623|OTHER|||||||0.003|||||||Kruskal-Wallis|||Pain at rest 36 h||||0.003
73955222|NCT02967016|147445623|OTHER|||||||0.02|||||||Kruskal-Wallis|||Pain at rest at 48 h||||.02
73955223|NCT02967016|147445624|OTHER|||||||0.43|||||||Kruskal-Wallis|||Satisfaction with pain control 6 h||||.43
73955224|NCT02967016|147445624|OTHER|||||||0.24|||||||Kruskal-Wallis|||Satisfaction with pain control 12 h||||.24
73955225|NCT02967016|147445624|OTHER|||||||0.012|||||||Kruskal-Wallis|||Satisfaction with pain control 24 h||||.012
73955226|NCT02967016|147445624|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Satisfaction with pain control 36 h||||<0.0001
73955227|NCT02967016|147445624|OTHER|||||||0.0005|||||||Kruskal-Wallis|||Satisfaction with pain control 48 h||||.0005
73955228|NCT01996644|147445626|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||ANOVA|||||||.043
73955229|NCT02072226|147445662|OTHER|Confidence Interval|Adjusted Risk Difference|-1.1|||||TWO_SIDED|95.0|-9.44|7.25||||||||7.25|-9.44|
73955230|NCT02072226|147445663|OTHER|Confidence Interval|Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.527|1.244||||||||1.244|0.527|
73955231|NCT02072226|147445664|OTHER|Confidence Interval|Odds Ratio (OR)|0.858|||||TWO_SIDED|95.0|0.529|1.393||||||||1.393|0.529|
73955232|NCT02072226|147445665|OTHER|Confidence Interval|difference in percentages|3.25|||||TWO_SIDED|95.0|0.75|7.38||||||||7.38|0.75|
73955233|NCT02072226|147445666|OTHER|Confidence Interval|difference in percentages|4.53|||||TWO_SIDED|95.0|-0.34|10.07||||||Any ICH within 36 hours reported by site||10.07|-0.34|
73955234|NCT02072226|147445666|OTHER|Confidence Interval|difference in percentages|3.87|||||TWO_SIDED|95.0|-1.23|9.49||||||Any ICH within 36 hours reported by central reader||9.49|-1.23|
73955235|NCT01124162|147445675|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|108.14|||||TWO_SIDED|90.0|97.43|120.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120.03|97.43|
73955236|NCT01124162|147445676|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.7|||||TWO_SIDED|90.0|98.57|104.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.93|98.57|
73955237|NCT01124162|147445677|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.5|||||TWO_SIDED|90.0|98.41|104.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.68|98.41|
73955238|NCT01124162|147445678|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.08|||||TWO_SIDED|90.0|98.24|106.06|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.06|98.24|
73955239|NCT01124162|147445679|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.31|||||TWO_SIDED|90.0|97.84|102.84|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.84|97.84|
73873877|NCT00286429|147289636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.80|<0.001
73873878|NCT00286429|147289636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.79|-0.35||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.35|-0.79|<0.001
73873879|NCT00286429|147289637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3||||0.128|TWO_SIDED|95.0|-25.9|3.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||3.3|-25.9|0.128
73873880|NCT00286429|147289637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1||||0.034|TWO_SIDED|95.0|-31.1|-1.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-1.2|-31.1|0.034
73873881|NCT00286429|147289638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.563|TWO_SIDED|95.0|-17.9|9.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||9.7|-17.9|0.563
73873882|NCT00286429|147289638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4||||0.084|TWO_SIDED|95.0|-26.4|1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||1.7|-26.4|0.084
73873883|NCT00286429|147289639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.3||||0.16|TWO_SIDED|95.0|-24.7|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.1|-24.7|0.160
73873884|NCT00286429|147289639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4||||0.02|TWO_SIDED|95.0|-32.1|-2.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-2.8|-32.1|0.020
73873885|NCT00286429|147289640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.9||||0.013|TWO_SIDED|95.0|-33.7|-4.0||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.0|-33.7|0.013
73981831|NCT01215253|147508883|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.577|TWO_SIDED|95.0|0.84|1.37|||Regression, Cox|||||1.37|0.84|0.577
73981832|NCT01215253|147508884|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.871|TWO_SIDED|95.0|0.69|1.37|||Regression, Cox|||||1.37|0.69|0.871
73981833|NCT01215253|147508885|SUPERIORITY|||||||0.508|||||||nonparametric Wilcoxon rank-sum test|||||||0.508
73981834|NCT01215253|147508886|SUPERIORITY|||||||0.948|||||||nonparametric Wilcoxon rank-sum test|||||||0.948
73873886|NCT00286429|147289640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5||||0.011|TWO_SIDED|95.0|-34.5|-4.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.5|-34.5|0.011
73873887|NCT00286429|147289641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.624|TWO_SIDED|95.0|-18.9|11.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||11.3|-18.9|0.624
73873888|NCT00286429|147289641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.853|TWO_SIDED|95.0|-16.7|13.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||13.8|-16.7|0.853
73873889|NCT00286429|147289642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.19|TWO_SIDED|95.0|-24.7|4.9||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.9|-24.7|0.190
73873890|NCT00286429|147289642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.154|TWO_SIDED|95.0|-25.8|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.1|-25.8|0.154
73873891|NCT00286429|147289643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7||||0.097|TWO_SIDED|95.0|-27.8|2.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||2.3|-27.8|0.097
73873892|NCT00286429|147289643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9||||0.01|TWO_SIDED|95.0|-35.1|-4.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.7|-35.1|0.010
73955240|NCT01124162|147445680|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.25|||||TWO_SIDED|90.0|97.87|102.69|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.69|97.87|
73955241|NCT02022462|147445681|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change of z-scores.||||.073
73955242|NCT02022462|147445681|SUPERIORITY||Mean Difference (Net)|0.19|STANDARD_DEVIATION|0.91||0.066|TWO_SIDED||||||t-test, 2 sided|||Within-group mean z-score change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.066
73955243|NCT02022462|147445682|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.983|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.983
73955244|NCT02022462|147445682|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_DEVIATION|1.95||0.533|TWO_SIDED||||||t-test, 2 sided|||Within-group mean change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.533
73955245|NCT02022462|147445683|SUPERIORITY|||||||0.731|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.731
73955246|NCT02022462|147445683|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|1.67||0.211|TWO_SIDED||||||t-test, 2 sided|||Within-group mean change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.211
73955247|NCT02022462|147445684|SUPERIORITY||Mean Difference (Net)|0.04||||0.244|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.244
73981835|NCT01215253|147508887|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.038|TWO_SIDED|95.0|0.55|0.98|||Regression, Cox|||||0.98|0.55|0.038
73873893|NCT00286429|147289644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.662|TWO_SIDED|95.0|-19.2|12.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||12.2|-19.2|0.662
73873894|NCT00286429|147289644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6||||0.03|TWO_SIDED|95.0|-33.4|-1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-1.7|-33.4|0.030
73873895|NCT00286429|147289645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.551||||0.075|TWO_SIDED|95.0|0.286|1.063||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||1.063|0.286|0.075
73873896|NCT00286429|147289645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.002|TWO_SIDED|95.0|0.191|0.695||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.695|0.191|0.002
73955248|NCT02022462|147445684|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_DEVIATION|0.35||0.016|TWO_SIDED||||||t-test, 2 sided|||||||.016
73955249|NCT02022462|147445685|SUPERIORITY||Mean Difference (Net)|0.4||||0.019|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.019
73955250|NCT02022462|147445685|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.66||0.609|TWO_SIDED||||||t-test, 2 sided|||||||.609
73955251|NCT02022462|147445686|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.203
73955252|NCT02022462|147445686|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|0.59||0.48|TWO_SIDED||||||t-test, 2 sided|||||||.480
73955253|NCT02022462|147445687|SUPERIORITY||Mean Difference (Net)|0.01||||0.897|TWO_SIDED||||||t-test, 2 sided|||||||.897
73955254|NCT02022462|147445687|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.48||0.903|TWO_SIDED||||||t-test, 2 sided|||||||.903
73955255|NCT02022462|147445688|SUPERIORITY||Mean Difference (Net)|-0.787||||0.433|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.433
73955256|NCT02022462|147445688|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.52||0.936|TWO_SIDED||||||t-test, 2 sided|||||||.936
73981836|NCT01215253|147508888|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.947|TWO_SIDED|95.0|0.73|1.41|||Regression, Cox|||||1.41|0.73|0.947
73981837|NCT01215253|147508889|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.414|TWO_SIDED|95.0|0.36|1.52|||Anderdon-Gill analysis|||||1.52|0.36|0.414
73981838|NCT00949234|147508890|OTHER||||||<|0.05|||||||Chi-squared|||There was no power calculation for this analysis. The study was mainly descriptive, but Chi-square tests were used to determine if there were differences between individuals who were retained at the 24 Week Follow-up visit from individuals who were not retained at the 24 Week Follow-up visit.||||<0.05
74009175|NCT02303704|147569151|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means between the two groups|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73955257|NCT02022462|147445689|SUPERIORITY|||||||0.228|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change in z-scores of diet.||||.228
73955258|NCT02022462|147445689|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_DEVIATION|1.03||0.617|TWO_SIDED||||||t-test, 2 sided|||||||.617
73955259|NCT02022462|147445690|SUPERIORITY||Mean Difference (Net)|0.01||||0.894|TWO_SIDED||||||t-test, 2 sided|||||||.894
73955260|NCT02022462|147445690|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.46||0.93|TWO_SIDED||||||t-test, 2 sided|||||||.930
73955261|NCT02022462|147445691|SUPERIORITY||Mean Difference (Net)|0.15||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||.530
73955262|NCT02022462|147445691|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_DEVIATION|1.27||0.458|TWO_SIDED||||||t-test, 2 sided|||||||.458
73955263|NCT02022462|147445692|SUPERIORITY||Mean Difference (Net)|0.31||||0.036|TWO_SIDED||||||t-test, 2 sided|||||||.036
73955264|NCT02022462|147445692|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|1.0||0.892|TWO_SIDED||||||t-test, 2 sided|||||||.892
73955265|NCT02022462|147445693|SUPERIORITY||Mean Difference (Net)|0.41||||0.931|TWO_SIDED||||||t-test, 2 sided|||||||.931
73955266|NCT02022462|147445693|SUPERIORITY||Mean Difference (Net)|-6.43|STANDARD_DEVIATION|24.34||0.058|TWO_SIDED||||||t-test, 2 sided|||||||.058
73955267|NCT02022462|147445694|SUPERIORITY||Mean Difference (Net)|0.4||||0.576|TWO_SIDED||||||t-test, 2 sided|||||||.576
73955268|NCT02022462|147445694|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_DEVIATION|33.89||0.829|TWO_SIDED||||||t-test, 2 sided|||||||.829
73955269|NCT02022462|147445695|SUPERIORITY|||||||0.792|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.792
73955270|NCT02022462|147445695|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_DEVIATION|0.55||0.622|TWO_SIDED||||||t-test, 2 sided|||||||.622
73955271|NCT02022462|147445696|SUPERIORITY||Mean Difference (Net)|1.986||||0.049|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.049
73955272|NCT02022462|147445696|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_DEVIATION|1.67||0.211|TWO_SIDED||||||t-test, 2 sided|||||||.211
73955273|NCT02680756|147445697|NON_INFERIORITY|A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).|Risk Difference (RD)|-0.17||||0.298|TWO_SIDED|95.0|-0.28|-0.06|||t-test, 2 sided|||||-0.06|-0.28|0.298
73955274|NCT02680756|147445698|NON_INFERIORITY|A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).|Risk Difference (RD)|-0.17||||0.341|TWO_SIDED|95.0|-0.3|-0.05|||t-test, 2 sided|||||-0.05|-0.30|0.341
73955275|NCT04310579|147445738|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.22|ONE_SIDED|95.0||2.5||To demonstrate an effect of oxycodone with midazolam compared to oxycodone alone, it is necessary that the upper bound of the one-sided 95% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone with midazolam compared to oxycodone alone.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||2.5||0.22
73955276|NCT04310579|147445739|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.01|ONE_SIDED|97.5||-0.6||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-0.6||0.01
73955277|NCT04310579|147445739|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.28|ONE_SIDED|97.5||2.8||To demonstrate an effect of oxycodone with quetiapine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||2.8||0.28
73955278|NCT04310579|147445740|SUPERIORITY||Mean Difference (Final Values)|-10.2|||<|0.001|ONE_SIDED|97.5||-6.3||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-6.3||<0.001
73981839|NCT03785756|147508891|EQUIVALENCE|The primary analysis was based on a two-sided test at the significance level of 0.05. The treatment difference is presented with a 95% confidence interval (CI).|Mean Difference (Final Values)|34.05|||<|0.0001|TWO_SIDED|95.0|26.72|41.38|||ANCOVA|Estimates from an ANCOVA model with SPID12 score as the dependent variable. Terms for treatment and baseline pain score were included as covariates.||The primary efficacy hypothesis was that SPID12 for placebo was equal to SPID12 for ibuprofen 2 × 300 mg PR tablets.||41.38|26.72|<0.0001
73981840|NCT00988429|147508978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058||95.0|||||ANCOVA|||||||0.058
73981841|NCT00988429|147508978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||ANCOVA|||||||0.004
73981842|NCT00988429|147508979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|||||||ANCOVA|||||||0.068
73981843|NCT00988429|147508979|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
73981844|NCT01074229|147508980|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|Using Dunns test with Bonferroni conrrection for individual comparisons.||||||.05
74089627|NCT00754494|147732032|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.369
73955279|NCT04310579|147445740|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.37|ONE_SIDED|97.5||3.2||To demonstrate an effect of oxycodone with quetiapine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||3.2||0.37
73955280|NCT04310579|147445741|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.005|ONE_SIDED|95.0||-2.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone compared to placebo, it is necessary that the upper bound of the one-sided 95% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone compared to placebo.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||-2.5||0.005
73955281|NCT04310579|147445741|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.37|ONE_SIDED|95.0||3.7||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of midazolam compared to placebo, it is necessary that the upper bound of the one-sided 95% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of midazolam compared to placebo.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||3.7||0.37
73955282|NCT04310579|147445742|SUPERIORITY||Mean Difference (Final Values)|-9.3|||<|0.001|ONE_SIDED|97.5||-3.9||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.9||<0.001
73955283|NCT04310579|147445742|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.67|ONE_SIDED|97.5||6.4||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of quetiapine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of quetiapine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||6.4||0.67
73955284|NCT04310579|147445744|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.33|TWO_SIDED|90.0|0.96|1.17||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.17|0.96|0.33
73955285|NCT04310579|147445744|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.25|||<|0.001|TWO_SIDED|90.0|1.14|1.37||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.37|1.14|<0.001
73955286|NCT04310579|147445745|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.3|||<|0.001|TWO_SIDED|90.0|1.19|1.43||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.43|1.19|<0.001
73981845|NCT01074229|147508980|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|28.0||||0.05|TWO_SIDED|95.0|9.0|37.0|||Dunns test|Bonferonni correction||||37|9|.05
73981846|NCT01074229|147508980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0||||0.05|TWO_SIDED|95.0|14.0|42.0|||Dunns Test|Bonferroni correction||||42|14|.05
73981847|NCT01074229|147508981|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|With Dunns test and Bonferonni correction.||||||.05
73981848|NCT01074229|147508981|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.0||||0.003|TWO_SIDED|95.0|3.0|15.0|||Dunns test|||||15|3|0.003
73981849|NCT01074229|147508981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.14|TWO_SIDED|95.0|-1.0|12.0|||Dunns test|||||12|-1|0.14
73873897|NCT00286429|147289646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||<|0.001|TWO_SIDED|95.0|0.198|0.619||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo arm. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.619|0.198|<0.001
73873898|NCT00286429|147289646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.339|||<|0.001|TWO_SIDED|95.0|0.189|0.608||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.608|0.189|<0.001
73873899|NCT00286429|147289647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156||||0.286|TWO_SIDED|95.0|-0.131|0.443||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.443|-0.131|0.286
73873900|NCT00286429|147289647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.477||||0.001|TWO_SIDED|95.0|0.188|0.765||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.765|0.188|0.001
73955287|NCT04310579|147445745|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.39|||<|0.001|TWO_SIDED|90.0|1.22|1.57||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.57|1.22|<0.001
73955288|NCT04310579|147445747|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.03||||0.64|TWO_SIDED|90.0|0.91|1.17||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.17|0.91|0.64
73955289|NCT04310579|147445747|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.24|TWO_SIDED|90.0|0.98|1.15||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.15|0.98|0.24
73955290|NCT04310579|147445748|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.1||||0.05|TWO_SIDED|90.0|1.02|1.19||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.19|1.02|0.05
73955291|NCT04310579|147445748|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.27|||<|0.001|TWO_SIDED|90.0|1.19|1.36||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.36|1.19|<0.001
73955292|NCT03635112|147445749|SUPERIORITY||Least Square Mean Difference|-0.76||||0.97|TWO_SIDED|95.0|-40.62|39.11|||Mixed Model Repeated Measures Analysis|||||39.11|-40.62|0.970
73955293|NCT03635112|147445749|SUPERIORITY||Least Square Mean Difference|-13.13||||0.51|TWO_SIDED|95.0|-52.46|26.19|||Mixed Model Repeated Measures Analysis|||||26.19|-52.46|0.510
73955294|NCT03635112|147445750|SUPERIORITY||Difference in Proportion|-0.07||||0.5102|TWO_SIDED|95.0|-0.277|0.135|||Cochran-Mantel-Haenszel Chi-square Test|||||0.135|-0.277|0.5102
73955295|NCT03635112|147445750|SUPERIORITY||Difference in Proportion|0.02||||0.8591|TWO_SIDED|95.0|-0.181|0.218|||Cochran-Mantel-Haenszel Chi-square Test|||||0.218|-0.181|0.8591
73955296|NCT03635112|147445751|SUPERIORITY||Difference in Proportion|-0.13||||0.1805|TWO_SIDED|95.0|-0.322|0.061|||Cochran-Mantel-Haenszel Chi-square Test|||||0.061|-0.322|0.1805
73955297|NCT03635112|147445751|SUPERIORITY||Difference in Proportion|-0.01||||0.9215|TWO_SIDED|95.0|-0.204|0.184|||Cochran-Mantel-Haenszel Chi-square Test|||||0.184|-0.204|0.9215
73955298|NCT03635112|147445752|SUPERIORITY||Least Square Mean Difference|1.6||||0.316|TWO_SIDED|95.0|-1.6|4.8|||ANCOVA|||||4.8|-1.6|0.316
73955299|NCT03635112|147445752|SUPERIORITY||Least Square Mean Difference|0.0||||0.988|TWO_SIDED|95.0|-3.2|3.2|||ANCOVA|||||3.2|-3.2|0.988
73955300|NCT03635112|147445753|SUPERIORITY||Difference in Proportion|-0.11||||0.1828|TWO_SIDED|95.0|-0.27|0.059|||Cochran-Mantel-Haenszel Chi-square Test|||||0.059|-0.270|0.1828
73955301|NCT03635112|147445753|SUPERIORITY||Difference in Proportion|0.06||||0.5785|TWO_SIDED|95.0|-0.133|0.244|||Cochran-Mantel-Haenszel Chi-square Test|||||0.244|-0.133|0.5785
73955302|NCT03635112|147445754|SUPERIORITY||Difference in Proportion|-0.07||||0.3776|TWO_SIDED|95.0|-0.225|0.095|||Cochran-Mantel-Haenszel Chi-square Test|||||0.095|-0.225|0.3776
73955303|NCT03635112|147445754|SUPERIORITY||Difference in Proportion|-0.04||||0.6063|TWO_SIDED|95.0|-0.189|0.111|||Cochran-Mantel-Haenszel Chi-square Test|||||0.111|-0.189|0.6063
73955304|NCT03006341|147445761|OTHER||C-Statistic|0.81|||||||||||Regression, Logistic|Logistic regression with bleeding history or predisposition as dependent and treatment groups and claims based variables as the independent variables|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a receiver operating characteristic (ROC) curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
73955305|NCT03006341|147445763|OTHER||Adjusted R squared statistic|0.02|||||||||||Regression, Linear|Logistic regression model with serum creatinine as the dependent variable and treatment groups and claims based variables as the independent variables|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
73981850|NCT02964234|147508982|SUPERIORITY||Odds Ratio (OR)|10.59||||0.005|TWO_SIDED|95.0|2.01|56.31||We clustered by cohort, given both interventions used a group format, and adjusted for age, socioeconomic status (education, income, insurance status) baseline mammography history, and baseline mammography intention.|Regression, Logistic|||We conducted logistic regressions, clustering by cohort, given both interventions used a group format, and adjusting for age, education, income, insurance status, baseline mammography history, and baseline mammography intention. The null hypothesis was there would be no study arm differences. A priori power analysis suggested that a sample size of 150, assuming alpha = .05, power = .80 would lead us to detect medium/large effects (OR = 2.8).||56.31|2.01|.005
74033591|NCT03382899|147619961|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7626|TWO_SIDED|95.0|0.5|2.5|||Cochran-Mantel-Haenszel||Odds Ratio stratified by histology type, squamous versus non-squamous based on interactive web response system (IWRS). 95% Confidence intervals (CIs) were estimated using the Clopper-Pearson method.|||2.5|0.5|0.7626
73955306|NCT03006341|147445765|OTHER||Adjusted R squared statistic|0.04|||||||||||Regression, Linear|Linear regression model with duration of atrial fibrillation as dependent and treatment groups and claims based variables as independent variables|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
73955307|NCT03006341|147445771|OTHER||C-Statistic|0.88|||||||||||Regression, Logistic|Logistic regression model with diabetes as the dependent variable and treatment groups and claims based variables as the independent variables.|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
73981851|NCT02964234|147508983|SUPERIORITY||Slope|-0.19||||0.03|TWO_SIDED|95.0|-0.34|-0.04|||Regression, Linear|With GEE. Models had exchangeable correlation structure, a gamma distribution, and log link.||Analyses were conducted using GEE with an exchangeable correlation structure and a gamma distribution with log link. All models included study arm, time, and the study arm\*time. Covariates included age, education, and mammography history. With 150 Latinas, alpha = 0.05, power = 0.80, ICC = 0.0-0.05, we expected to detect small/medium interaction effects.||-0.04|-0.34|0.03
74033592|NCT03382899|147619962|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.263|TWO_SIDED|95.0|0.722|3.243|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the methods of Brookmeyer and Crowley, and Greenwood, respectively.|||3.243|0.722|0.263
74033593|NCT03382899|147619963|SUPERIORITY||Hazard Ratio (HR)|0.975||||0.2|TWO_SIDED|95.0|0.571|1.663|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the Kaplan-Meier method.|||1.663|0.571|0.20
74033594|NCT03382899|147619964|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9418|TWO_SIDED|95.0|0.5|2.3|||Cochran-Mantel-Haenszel||Odds Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the Clopper-Pearson method.|||2.3|0.5|0.9418
74033595|NCT03382899|147619965|SUPERIORITY||Hazard Ratio (HR)|1.124||||0.8312|TWO_SIDED|95.0|0.384|3.289|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the methods of Brookmeyer and Crowley, and Greenwood, respectively.|||3.289|0.384|0.8312
74033596|NCT02426658|147619969|SUPERIORITY|||||||0.7044|||||||Mixed Models Analysis|||||||0.7044
74033597|NCT03302416|147620005|SUPERIORITY|Baseline scan VT vs. Post-hydrocortisone scan VT||||||0.005|||||||Linear mixed model|||||||0.005
74033598|NCT02592629|147620006|EQUIVALENCE|ANOVA|||||<|0.05|||||||ANOVA|||||||<0.05
74033599|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.0||||0.9946|TWO_SIDED|95.0|0.83|1.2|||Regression, Cox|Cox regression of time to first vascular AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/ Placebo\].|Time to first vascular AE (SAF-M1)||1.20|0.83|0.9946
74033600|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.95||||0.7474|TWO_SIDED|95.0|0.72|1.27|||Regression, Cox|Cox regression of time to first vascular AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo. \[Treatment/Placebo\].|Time to first vascular AE (SAF-M2)||1.27|0.72|0.7474
74033601|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.03||||0.7943|TWO_SIDED|95.0|0.81|1.31|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with a term for treatment.|Comparison vs. Placebo \[Treatment / Placebo\]|Time to first vascular AE (Trial NCT01131676, all empagliflozin (10 and 25 mg vs. Placebo))||1.31|0.81|0.7943
74033602|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.97||||0.8518|TWO_SIDED|95.0|0.69|1.36|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs. Placebo \[Treatment / Placebo\].|Time to first vascular AE (Trial NCT03057951)||1.36|0.69|0.8518
74033603|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.93||||0.766|TWO_SIDED|95.0|0.56|1.53|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first vascular AE (Trial NCT03057977)||1.53|0.56|0.7660
74033604|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.15||||0.3612|TWO_SIDED|95.0|0.85|1.55|||Regression, Cox|Cox regression of time to first diabetic foot related AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\].|Time to first diabetic foot related AE (SAF-M1)||1.55|0.85|0.3612
74033605|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.44||||0.161|TWO_SIDED|95.0|0.86|2.4|||Regression, Cox|Cox regression of time to first diabetic foot related AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first diabetic foot related AE (SAF-M2)||2.40|0.86|0.1610
74033606|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.02||||0.9128|TWO_SIDED|95.0|0.71|1.47|||Regression, Cox|Cox regression for time to first diabetic foot related AE on treatment. Cox regression model with a term for treatment.|Comparison vs. Placebo \[Treatment/Placebo\]|Time to first diabetic foot related AE (Trial NCT01131676, all empagliflozin (10 and 25 mg) vs. Placebo)||1.47|0.71|0.9128
73873901|NCT00286429|147289648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202||||0.236|TWO_SIDED|95.0|-0.132|0.536||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.536|-0.132|0.236
73955308|NCT03006341|147445772|OTHER||C-Statistic|0.69|||||||||||Regression, Logistic|Logistic regression model with hyperlipidemia as the dependent variable and treatment groups and claims based variables as the independent variables.|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
74033607|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.81||||0.5276|TWO_SIDED|95.0|0.43|1.54|||Regression, Cox|Cox regression for time to first diabetic foot related AE. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs. Placebo \[Treatment/Placebo\]|Time to first diabetic foot related AE (Trial NCT03057951)||1.54|0.43|0.5276
74033608|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|4.72||||0.0048|TWO_SIDED|95.0|1.6|13.87|||Regression, Cox|Cox regression for time to first diabetic foot related AE. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment / Placebo\]|Time to first diabetic foot related AE (Trial NCT03057977)||13.87|1.60|0.0048
74033609|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.89||||0.1526|TWO_SIDED|95.0|0.77|1.04|||Regression, Cox|Cox regression of time to first infections potentially related to LLA's. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first infections potentially related to LLA's (SAF-M1)||1.04|0.77|0.1526
74033610|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.96||||0.743|TWO_SIDED|95.0|0.76|1.21|||Regression, Cox|Cox regression of time to first infection potentially related to LLA's. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first infection potentially related to LLA's (SAF-M2)||1.21|0.76|0.7430
74033611|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.85||||0.1049|TWO_SIDED|95.0|0.69|1.04|||Regression, Cox|Cox regression for infections potentially related to LLA-on treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs. Placebo)||1.04|0.69|0.1049
74033612|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.89||||0.395|TWO_SIDED|95.0|0.67|1.17|||Regression, Cox|Cox regression for infections potentially related to LLA on treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT03057951)||1.17|0.67|0.3950
74033613|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.19||||0.4429|TWO_SIDED|95.0|0.76|1.87|||Regression, Cox|Cox regression for infections potentially related to LLA on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT03057977)||1.87|0.76|0.4429
73873902|NCT00286429|147289648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372||||0.032|TWO_SIDED|95.0|0.032|0.712||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.712|0.032|0.032
74033614|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.89||||0.3396|TWO_SIDED|95.0|0.7|1.13|||Regression, Cox|Cox regression of time to first wound infections. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first wound/infection (SAF-M1)||1.13|0.70|0.3396
73873903|NCT00286429|147289649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126||||0.562|TWO_SIDED|95.0|-0.302|0.554||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.554|-0.302|0.562
73873904|NCT00286429|147289649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183||||0.407|TWO_SIDED|95.0|-0.251|0.616||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.616|-0.251|0.407
73955309|NCT03006341|147445773|OTHER||Adjusted R squared statistic|0.34|||||||||||Regression, Linear|Linear regression model with HAS-BLED score as the dependent variable and treatment groups and claims based variables as the independent variables.|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
73955310|NCT03101592|147445786|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-4.3|12.3|||||RD is for retention 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||12.3|-4.3|
73955311|NCT03101592|147445786|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|9.1|||||TWO_SIDED|95.0|0.9|17.2|||||RD is for retention 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||17.2|0.9|
73955312|NCT03101592|147445786|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|1.0|9.1|||||RD is for retention 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||9.1|1|
73955313|NCT03101592|147445786|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-0.8|1.6|||||RD is for transfer 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||1.6|-0.8|
73955314|NCT03101592|147445786|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.9|0.8|||||RD is for transfer 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.8|-0.9|
73981852|NCT02964234|147508984|SUPERIORITY||Odds Ratio (OR)|6.15|||<|0.0001|TWO_SIDED|95.0|2.82|13.32||Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size.|Ordinal regression|||We used ordinal regression, given the non-normal distribution revealed by preliminary analyses. Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size. Power analyses suggested that with 150 Latinas, alpha = .05, power = .80, we would be able to detect a small effect (Cohen's f = 0.05).||13.32|2.82|<0.0001
73981853|NCT00234832|147508985|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.162||||0.015|TWO_SIDED|95.0|1.029|1.311||No adjustment for multiple testing or interim analysis was performed. The primary outcome was tested at a 2-sided alpha level of 0.05.|Log Rank||The Cox model included factors for treatment, country, gender, and age (continuous) at Lead-in Period baseline. For the calculation of risk, the sibutramine arm is the numerator and the placebo arm is the denominator.|For the sample size calculation, a two-tailed alpha level of 0.05 was used along with power of 90%. The annual composite event rate in the placebo arm was assumed to be 7.0%. A sample of 3983 subjects in each of the 2 groups, corrected for a 30% noncompliance rate (15% in Year 1 and 6.3% in each year, Years 2 to 4), followed for at least 3 years was expected to have 90% power to detect a relative risk reduction of 15% with sibutramine relative to placebo.||1.311|1.029|0.015
73981854|NCT00234832|147508985|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01||||0.948|TWO_SIDED|95.0|0.738|1.384|||Log Rank|||This analysis included only subjects with DM only in a comparison of sibutramine and placebo.||1.384|0.738|0.948
73981855|NCT00234832|147508985|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.276||||0.149|TWO_SIDED|95.0|0.916|1.776|||Log Rank|||This analysis included only subjects with CV only in a comparison of sibutramine and placebo.||1.776|0.916|0.149
73981856|NCT00234832|147508985|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.182||||0.022|TWO_SIDED|95.0|1.024|1.365|||Log Rank|||This analysis included only subjects with CV + DM in a comparison of sibutramine and placebo.||1.365|1.024|0.022
73981857|NCT00234832|147508986|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.043||||0.543|TWO_SIDED|95.0|0.91|1.196|||Log Rank|||||1.196|0.910|0.543
73981858|NCT00234832|147508987|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.097||||0.051|TWO_SIDED|95.0|0.999|1.204|||Log Rank|||||1.204|0.999|0.051
73981859|NCT00234832|147508988|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.276||||0.022|TWO_SIDED|95.0|1.036|1.571|||Log Rank|||||1.571|1.036|0.022
73981860|NCT00234832|147508989|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.355||||0.025|TWO_SIDED|95.0|1.038|1.767|||Log Rank|||||1.767|1.038|0.025
73981861|NCT00234832|147508990|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.582||||0.343|TWO_SIDED|95.0|0.613|4.081|||Log Rank|||||4.081|0.613|0.343
73981862|NCT00234832|147508991|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.988||||0.899|TWO_SIDED|95.0|0.822|1.188|||Log Rank|||||1.188|0.822|0.899
73981863|NCT01799993|147509007|SUPERIORITY||Odds Ratio (OR)|0.841||||0.4263|TWO_SIDED|95.0|0.554|1.277|||Cochran-Mantel-Haenszel|||||1.277|0.554|0.4263
73981864|NCT01799993|147509008|SUPERIORITY|||||||0.6421|||||||Chi-squared|||||||0.6421
73981865|NCT01799993|147509009|SUPERIORITY|||||||0.7984|||||||Chi-squared|||||||0.7984
73981866|NCT01799993|147509010|SUPERIORITY|||||||0.7144|||||||ANOVA|||||||0.7144
73981867|NCT01799993|147509011|SUPERIORITY|||||||0.4278|||||||ANOVA|||||||0.4278
73981868|NCT00759681|147509038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.0538||0.05|TWO_SIDED|95.0|0.103|0.314|||Exact binomial confidence limit|Effectiveness: 95% confidence limits of the difference between groups, and ensuring that the lower limit of the difference was greater than 10%.||Effectiveness was evaluated using a superiority hypothesis, comparing treatment sites with regards to the proportion achieving immediate suture line sealing between the groups. Effectiveness was based on a two-tailed, 0.05 hypothesis test, with a minimum effect size set at 10%. The mean difference in the proportion of sites achieving immediate suture line sealing was compared between the Control and Investigation Device groups.||0.314|0.103|0.05
73981869|NCT00759681|147509039|NON_INFERIORITY_OR_EQUIVALENCE|Safety was evaluated using non-inferiority hypothesis evaluating the proportion of cases with any instance of sign. bleeding, neurological deficit or immune/inflammatory allergic response. Safety based on one-tailed, 0.05 alpha, with equivalence limit set at 15%.|Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.0671||0.05|ONE_SIDED|95.0||-0.003|||Exact binomial confidence limit|Safety: 95% confidence limits of the difference between groups, and ensuring that the upper limit of the difference was less than or equal to 15%.|The cumulative incidence of safety endpoints for the Investigational Treatment group was an average of 13.5% less than for the Control group.|The mean difference is equivalent to the proportion of Investigational Device patients minus the proportion of Control patients experiencing any instance of significant bleeding, neurological deficit or immune/inflammatory allergic response.||-0.003||0.05
74009176|NCT02303704|147569152|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means|||||<|0.05|TWO_SIDED|||||p-value \<0.05 was considered significant.|t-test, 2 sided|To compare the means between the two groups, to find out the significant difference between Group I and II.||Null Hypothesis: The dose of nor-adrenaline on weaning from CPB is same for Group I and II.||||<0.05
73955315|NCT03101592|147445786|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-1.7|0.7|||||RD is for transfer 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.7|-1.7|
73955316|NCT03101592|147445786|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||RD is for death 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.2|-0.4|
73955317|NCT03101592|147445786|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.9|0.8|||||RD is for death 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.8|-0.9|
73955318|NCT03101592|147445786|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||RD is for death 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.3|-0.3|
73955319|NCT01770860|147445790|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with Treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
73955320|NCT01770860|147445791|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
73981870|NCT01129011|147509050|SUPERIORITY_OR_OTHER||proportions|11.9||||0.001|TWO_SIDED|95.0|7.9|17.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||17.1|7.9|0.001
73981871|NCT01129011|147509051|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
73981872|NCT01129011|147509052|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Cochran-Mantel-Haenszel|||||||0.009
74033615|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.7||||0.105|TWO_SIDED|95.0|0.46|1.08|||Regression, Cox|Cox regression of time to first wound infections. Cox regression with terms for study, baseline diabetes status and treatment|Comparison versus Placebo \[Treatment/Placebo\].|Time to first wound/infection (SAF-M2)||1.08|0.46|0.1050
73955321|NCT01770860|147445792|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
73955322|NCT01770860|147445793|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
73955323|NCT01770860|147445794|SUPERIORITY_OR_OTHER|||||||0.0476|||||||Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect||||||0.0476
73955324|NCT02341534|147445797|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.21|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||||1.10|0.64|0.21
73981873|NCT01129011|147509053|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Cochran-Mantel-Haenszel|||||||0.007
73981874|NCT01129011|147509054|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
73981875|NCT02823574|147509060|SUPERIORITY||Odds Ratio (OR)|0.68||||0.2897|TWO_SIDED|95.5|0.33|1.43|||Mantel Haenszel|||Treatment A over Treatment B||1.43|0.33|0.2897
73981876|NCT02823574|147509065|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.78|1.41|||||computed using a cox proportional hazard model stratified by randomization PD-L1 and HPV status|||1.41|0.78|
73981877|NCT02823574|147509066|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.78|1.41|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.41|0.78|
73981878|NCT02823574|147509067|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.36|0.87|
73873905|NCT00286429|147289650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078||||0.716|TWO_SIDED|95.0|-0.344|0.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.500|-0.344|0.716
73955325|NCT03432533|147445825|NON_INFERIORITY|Conclusions for the primary efficacy hypothesis of efficacy of self-administration of romosozumab by AI/Pen compared with HCP-administered romosozumab by PFS at lumbar spine BMD at Month 6 was made using a 1-sided test with type 1 error rate of 0.025 and noninferiority margin of -2.0%.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.84|TWO_SIDED|95.0|-1.3|1.0|||ANCOVA|||||1.0|-1.3|0.84
73955326|NCT01648283|147445830|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73955327|NCT01446003|147445832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02|||||TWO_SIDED|90.0|-0.52|4.56|||Linear mixed effect models|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||If the upper limit of the 90% confidence interval lies below the bound 5 mmHg, the hypothesis that change from baseline in ambulatory 24-hour mean SBP in participants with mild to moderate hypertension following 10 days of multiple dosing of MK-8457 is similar to placebo will be supported.||4.56|-0.52|
73955328|NCT01446003|147445833|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.57|||||TWO_SIDED|90.0|0.19|2.96|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||||2.96|0.19|
73955329|NCT01446003|147445834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||||TWO_SIDED|90.0|2.44|13.35|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after AM dosing||13.35|2.44|
73955330|NCT01446003|147445834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|90.0|-5.68|3.81|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after PM dosing||3.81|-5.68|
73955331|NCT01446003|147445834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.26|||||TWO_SIDED|90.0|0.81|9.71|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after AM dosing||9.71|0.81|
73955332|NCT01446003|147445834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|||||TWO_SIDED|90.0|-4.55|1.17|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after PM dosing||1.17|-4.55|
73955333|NCT05550337|147445843|EQUIVALENCE|The 90% CI for the Test-to-Reference ratio of LS mean percent reduction from Baseline to Week 12/Day 84, in the inflammatory lesion counts to be contained within (0.80, 1.25).|Mean Difference (Net)|0.998|||||TWO_SIDED|90.0|0.927|1.076||||||||1.076|0.927|
73955334|NCT05550337|147445844|EQUIVALENCE|The 90% CI for the Test-to-Reference ratio of LS mean percent reduction from Baseline to Week 12/Day 84, in the non-inflammatory lesion counts to be contained within (0.80, 1.25).|Mean Difference (Net)|1.116|||||TWO_SIDED|90.0|1.017|1.228||||||||1.228|1.017|
73955335|NCT02266329|147445863|SUPERIORITY||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|1.6||0.034|TWO_SIDED|95.0|-6.9|-0.8||The significance of the study visit by treatment interaction with study visit coded as baseline, 4 weeks, 8 weeks, and 12 weeks.|Mixed Models Analysis|||Change from baseline in headache (HA) frequency (1. Primary Outcome Measure) is based on linear mixed effects regression of outcome on study visit by treatment interaction with study participant as a random effect.||-0.8|-6.9|0.034
73955336|NCT03499600|147445878|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.03|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on caregiver perceptions of the extent to which the provider understood the caregivers' values or what is important to them.||||.03
73955337|NCT03499600|147445878|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.68|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on caregiver satisfaction with the intake.||||.68
73981879|NCT02823574|147509068|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.81|1.45|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.45|0.81|
73981880|NCT02823574|147509069|SUPERIORITY||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.81|1.61|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.61|0.81|
73981881|NCT02823574|147509094|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.32|1.29|||Mantel Haenszel|||Treatment A over Treatment B||1.29|0.32|
73981882|NCT00237718|147509114|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
73981883|NCT00237718|147509115|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
73981884|NCT02991118|147509147|SUPERIORITY||Difference in LS mean|-17.42|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-20.951|-13.896|||ANCOVA|||||-13.896|-20.951|<0.001
73981885|NCT02991118|147509148|SUPERIORITY||Difference in LS mean|-14.77|STANDARD_ERROR_OF_MEAN|2.418|<|0.001|TWO_SIDED|95.0|-19.504|-10.027|||ANCOVA|||||-10.027|-19.504|<0.001
73981886|NCT02991118|147509149|SUPERIORITY||Difference in LS mean|-13.03|STANDARD_ERROR_OF_MEAN|1.652|<|0.001|TWO_SIDED|95.0|-16.27|-9.794|||ANCOVA|||||-9.794|-16.270|<0.001
73955338|NCT03499600|147445878|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.03|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on provider perceptions of the extent to which the provider understood the caregivers' values or what is important to them.||||.03
73955339|NCT03499600|147445878|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.|||||<|0.05|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on provider satisfaction with the intake.||||<.05
73955340|NCT03499600|147445880|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.93|||||||Regression, Linear|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on therapeutic alliance.||||.93
73955341|NCT03499600|147445880|SUPERIORITY|||||||0.9|||||||Regression, Linear|||Tested the moderation effects of language of service reception and condition on therapeutic alliance.||||.90
73955342|NCT03499600|147445881|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery. Baseline ECBI score was included as a covariate for the treatment response analyses.||||||0.171|||||||Regression, Logistic|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A logistic regression tested condition effects on treatment response.||||.171
73955343|NCT03499600|147445881|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Testes the effects of the moderation of language of service delivery and condition on treatment response.||||<.05
73955344|NCT03499600|147445882|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.38|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on session attendance.||||.38
73955345|NCT03499600|147445882|SUPERIORITY|||||||0.01|||||||Regression, Linear|||Analyses tested the moderation of language of service delivery and condition on session attendance.||||.01
73981887|NCT02991118|147509150|SUPERIORITY||Difference in LS mean|-11.2|STANDARD_ERROR_OF_MEAN|1.224|<|0.001|TWO_SIDED|95.0|-13.599|-8.801|||ANCOVA|||||-8.801|-13.599|<0.001
73981888|NCT02991118|147509151|SUPERIORITY||Difference in LS mean|-13.02|STANDARD_ERROR_OF_MEAN|1.587|<|0.001|TWO_SIDED|95.0|-16.13|-9.907|||ANCOVA|||||-9.907|-16.130|<0.001
73981889|NCT02991118|147509152|SUPERIORITY||Location shift|-8.733|||<|0.039|TWO_SIDED|95.0|-17.238|-0.434|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-0.434|-17.238|<0.039
73981890|NCT02991118|147509155|SUPERIORITY||Difference in LS mean|4.89|STANDARD_ERROR_OF_MEAN|3.258||0.134|TWO_SIDED|95.0|-1.504|11.292|||ANCOVA|||||11.292|-1.504|0.134
73981891|NCT02991118|147509156|SUPERIORITY||Difference in LS mean|-6.13|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-8.369|-3.896|||ANCOVA|||||-3.896|-8.369|<0.001
73981892|NCT02991118|147509157|SUPERIORITY||Difference in LS mean|-12.27|STANDARD_ERROR_OF_MEAN|2.314|<|0.001|TWO_SIDED|95.0|-16.813|-7.722|||ANCOVA|||||-7.722|-16.813|<0.001
73981893|NCT02991118|147509158|SUPERIORITY||Difference in LS mean|-12.63|STANDARD_ERROR_OF_MEAN|2.01|<|0.001|TWO_SIDED|95.0|-16.58|-8.682|||ANCOVA|||||-8.682|-16.580|<0.001
73981894|NCT02991118|147509159|SUPERIORITY||Difference in LS mean|-9.92|STANDARD_ERROR_OF_MEAN|1.976|<|0.001|TWO_SIDED|95.0|-13.803|-6.037|||ANCOVA|||||-6.037|-13.803|<0.001
73981895|NCT02991118|147509160|SUPERIORITY||Difference in LS mean|-10.77|STANDARD_ERROR_OF_MEAN|1.489|<|0.001|TWO_SIDED|95.0|-13.698|-7.848|||ANCOVA|||||-7.848|-13.698|<0.001
73981896|NCT02991118|147509161|SUPERIORITY||Difference in LS mean|-8.36|STANDARD_ERROR_OF_MEAN|1.458|<|0.001|TWO_SIDED|95.0|-11.223|-5.493|||ANCOVA|||||-5.493|-11.223|<0.001
73981897|NCT02991118|147509162|SUPERIORITY||Difference in LS mean|-13.0|STANDARD_ERROR_OF_MEAN|2.451|<|0.001|TWO_SIDED|95.0|-17.829|-8.175|||ANCOVA|||||-8.175|-17.829|<0.001
73981898|NCT02991118|147509163|SUPERIORITY||Difference in LS mean|-9.58|STANDARD_ERROR_OF_MEAN|1.796|<|0.001|TWO_SIDED|95.0|-13.107|-6.047|||ANCOVA|||||-6.047|-13.107|<0.001
73981899|NCT02991118|147509164|SUPERIORITY||Location shift|-21.278|||<|0.001|TWO_SIDED|95.0|-32.25|-10.034|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-10.034|-32.250|<0.001
74009177|NCT02303704|147569153|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to chek the equality of means between the two groups|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
74009178|NCT02303704|147569154|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||p- value less than 0.05 was considered as significant difference in proportion between the two groups|Chi-squared|two compare the qualitative data between two groups||Null Hypothesis:The proportion of IABP use is same between the two groups||||<0.05
74009179|NCT02303704|147569155|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||P-value \<0.05 was considered to be significant i.e. operative mortality is not same between the two groups|Fisher Exact|Fisher exact test was used because 1 cell (25%) have expected count less than 5.||Null Hypothesis: Operative mortality ratio is same in both groups||||<0.05
74009180|NCT02774616|147569165|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0004|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Ilivia ICD family until the 3- month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||||0.0004
73873906|NCT00286429|147289650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156||||0.474|TWO_SIDED|95.0|-0.272|0.583||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.583|-0.272|0.474
73873907|NCT00286429|147289651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.7|TWO_SIDED|95.0|-0.324|0.482||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.482|-0.324|0.700
73873908|NCT00286429|147289651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.839|TWO_SIDED|95.0|-0.366|0.45||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.450|-0.366|0.839
73873909|NCT00286429|147289652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.091|TWO_SIDED|95.0|-0.045|0.61||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.610|-0.045|0.091
73955346|NCT03499600|147445882|SUPERIORITY|||||||0.56|||||||Regression, Linear|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on homework completion. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.56
73955347|NCT03499600|147445882|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analyses tested the moderation effect of language of service delivery and condition on homework completion.||||<.01
73955348|NCT03499600|147445882|SUPERIORITY|||||||0.4|||||||Regression, Logistic|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Logistic regressions tested condition effects on initial session attendance. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.40
74033616|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.0||||0.9919|TWO_SIDED|95.0|0.74|1.35|||Regression, Cox|Cox regression for time to first wound/infection on-treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||1.35|0.74|0.9919
73955349|NCT03499600|147445882|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||Analyses tested the moderation of language of service delivery and condition on initial session attendance.||||.01
73955350|NCT03499600|147445882|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A Logistic regression tested condition effects on completion of first treatment module. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.03
73955351|NCT03499600|147445882|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||Analyses tested the moderation of language of service delivery and condition on completion of first treatment module.||||.03
73955352|NCT03499600|147445883|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.854|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on treatment satisfaction.||||.854
73955353|NCT03499600|147445884|SUPERIORITY|||||||0.319|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested change in ECBI score from baseline to post treatment.||||.319
73955354|NCT02014558|147445902|OTHER||Slope|0.99|||||TWO_SIDED|90.0|0.788|1.19||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.||1.19|0.788|
74033617|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.79||||0.3634|TWO_SIDED|95.0|0.48|1.31|||Regression, Cox|Cox regression for time to first wound/infection on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT03057951)||1.31|0.48|0.3634
73955355|NCT02014558|147445902|OTHER||Slope|1.22|||||TWO_SIDED|90.0|1.0|1.43||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.||1.43|1.00|
73873910|NCT00286429|147289652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.459|TWO_SIDED|95.0|-0.207|0.457||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.457|-0.207|0.459
73955356|NCT02014558|147445903|OTHER||Slope|0.808|||||TWO_SIDED|90.0|0.629|0.988||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.||0.988|0.629|
73955357|NCT02014558|147445903|OTHER||Slope|1.21|||||TWO_SIDED|90.0|1.02|1.41||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.||1.41|1.02|
73955358|NCT02014558|147445941|OTHER||Geometric LS Mean Ratio|109.46|||||TWO_SIDED|90.0|49.82|240.48||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of least squares (LS) means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||240.48|49.82|
73955359|NCT02014558|147445942|OTHER||Geometric LS Mean Ratio|149.9||||||90.0|74.88|300.06||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam alone and 1-hydroxymidazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||300.06|74.88|
73955360|NCT02014558|147445943|OTHER||Geometric LS Mean Ratio|111.64|||||TWO_SIDED|90.0|69.54|179.25||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||179.25|69.54|
73955361|NCT02014558|147445944|OTHER||Geometric LS Mean Ratio|123.47|||||TWO_SIDED|90.0|72.41|210.52||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam/midazolam alone and 1-hydroxymidazolam/midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||210.52|72.41|
73955362|NCT02014558|147445949|OTHER||Geometric LS Mean Ratio|93.96|||||TWO_SIDED|90.0|75.29|117.26||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||117.26|75.29|
73955363|NCT02014558|147445950|OTHER||Geometric LS Mean Ratio|91.46|||||TWO_SIDED|90.0|74.6|112.12||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||112.12|74.60|
73955364|NCT02014558|147445951|OTHER||Geometric LS Mean Ratio|97.71|||||TWO_SIDED|90.0|74.19|128.7||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||128.70|74.19|
74089628|NCT00754494|147732032|SUPERIORITY_OR_OTHER|||||||0.085|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.085
73955365|NCT02014558|147445954|OTHER||Geometric LS Mean Ratio|106.42|||||TWO_SIDED|90.0|85.28|132.81||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||132.81|85.28|
74089629|NCT00754494|147732032|SUPERIORITY_OR_OTHER|||||||0.233|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.233
73955366|NCT02014558|147445956|OTHER||Geometric LS Mean Ratio|83.93|||||TWO_SIDED|90.0|46.53|151.39||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||151.39|46.53|
73955367|NCT02014558|147445958|OTHER||Geometric LS Mean Ratio|82.84|||||TWO_SIDED|90.0|40.25|170.48||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||170.48|40.25|
73955368|NCT02501811|147446068|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|1.05||0.993|TWO_SIDED|95.0|-2.19|2.023|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values|Confidence intervals based on t-test|||2.023|-2.190|0.993
73981900|NCT02991118|147509165|SUPERIORITY||Location shift|-7.587||||0.102|TWO_SIDED|95.0|-16.978|1.653|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||1.653|-16.978|0.102
74033618|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.52||||0.1177|TWO_SIDED|95.0|0.23|1.18|||Regression, Cox|Cox regression for time to first wound/infection on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT03057977)||1.18|0.23|0.1177
74033619|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.0||||0.9992|TWO_SIDED|95.0|0.84|1.19|||Regression, Cox|Cox regression of time to first nervous system disorder. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first nervous system disorder (SAF-M1)||1.19|0.84|0.9992
74033620|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.09||||0.6274|TWO_SIDED|95.0|0.78|1.52|||Regression, Cox|Cox regression of time to first nervous system disorder. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first nervous system disorder (SAF-M2)||1.52|0.78|0.6274
74033621|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|0.97||||0.7597|TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first nervous system disorder (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||1.19|0.79|0.7597
74033622|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.08||||0.7067|TWO_SIDED|95.0|0.74|1.57|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first nervous system disorder (Trial NCT03057951)||1.57|0.74|0.7067
74033623|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.12||||0.7404|TWO_SIDED|95.0|0.56|2.25|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|time to first nervous system disorder (Trial NCT03057977)||2.25|0.56|0.7404
74033624|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.21||||0.1765|TWO_SIDED|95.0|0.92|1.58|||Regression, Cox|Cox regression of time to first volume depletion AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first volume depletion AE (SAF-M1)||1.58|0.92|0.1765
74033625|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.22||||0.1978|TWO_SIDED|95.0|0.9|1.66|||Regression, Cox|Cox regression of time to first volume depletion AE. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first volume depletion AE (SAF-M2)||1.66|0.90|0.1978
74033626|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.14||||0.6561|TWO_SIDED|95.0|0.64|2.05|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||2.05|0.64|0.6561
74033627|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.29||||0.1699|TWO_SIDED|95.0|0.9|1.87|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT03057951)||1.87|0.90|0.1699
74033628|NCT04937816|147620023|OTHER||Hazard Ratio (HR)|1.08||||0.7944|TWO_SIDED|95.0|0.62|1.87|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT03057977)||1.87|0.62|0.7944
74033629|NCT04937816|147620024|OTHER||Hazard Ratio (HR)|1.02||||0.9276|TWO_SIDED|95.0|0.73|1.42|||Regression, Cox|Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\].|||1.42|0.73|0.9276
74033630|NCT04937816|147620024|OTHER||Hazard Ratio (HR)|0.85||||0.6205|TWO_SIDED|95.0|0.45|1.6|||Regression, Cox|Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\]|||1.60|0.45|0.6205
74033631|NCT04937816|147620024|OTHER||Hazard Ratio (HR)|1.09||||0.6768|TWO_SIDED|95.0|0.73|1.63|||Regression, Cox|Cox regression model with terms for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Empagliflozin (10 mg + 25 mg) versus Placebo.||1.63|0.73|0.6768
74033632|NCT04937816|147620024|OTHER||Hazard Ratio (HR)|0.73||||0.4294|TWO_SIDED|95.0|0.34|1.59|||Regression, Cox|Cox regression model with terms for baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment /Placebo\]|||1.59|0.34|0.4294
74033633|NCT04937816|147620024|OTHER||Hazard Ratio (HR)|1.17||||0.7826|TWO_SIDED|95.0|0.39|3.47|||Regression, Cox|Cox regression model with terms for baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment /Placebo\]|||3.47|0.39|0.7826
74033634|NCT05513391|147620025|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio was greater than (\>) 0.667 for each virus strain.|GMT Ratio|1.28|||||TWO_SIDED|95.0|0.948|1.73||||||Statistical analysis for A/H1N1||1.73|0.948|
74033635|NCT05513391|147620025|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|2.53|||||TWO_SIDED|95.0|1.93|3.3||||||Statistical analysis for A/H3N2||3.30|1.93|
74033636|NCT05513391|147620025|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|0.515|||||TWO_SIDED|95.0|0.397|0.668||||||Statistical analysis for B/Victoria||0.668|0.397|
74033637|NCT05513391|147620025|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.799|1.3||||||Statistical analysis for B/Yamagata||1.30|0.799|
74033638|NCT05513391|147620026|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|7.1|||||TWO_SIDED|95.0|-1.55|15.7||||||Statistical analysis for A/H1N1||15.7|-1.55|
74033639|NCT05513391|147620026|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|15.4|||||TWO_SIDED|95.0|5.8|24.7||||||Statistical analysis for A/H3N2||24.7|5.80|
74033640|NCT05513391|147620026|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|-6.91|||||TWO_SIDED|95.0|-14.02|0.1||||||Statistical analysis for B/Victoria||0.10|-14.02|
73873911|NCT00286429|147289654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.65||||0.016|TWO_SIDED|95.0|1.589|100.682||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||100.682|1.589|0.016
73873912|NCT00286429|147289654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.255||||0.023|TWO_SIDED|95.0|1.401|90.379||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo was evaluated inferentially with a Wald test at the 0.05 significance level||90.379|1.401|0.023
73873913|NCT00286429|147289655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.777|||<|0.001|TWO_SIDED|95.0|2.047|16.305||No multiplicity adjustments.|ANCOVA|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||16.305|2.047|<0.001
73873914|NCT00286429|147289655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.784|||<|0.001|TWO_SIDED|95.0|3.54|27.039||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||27.039|3.540|<0.001
73873915|NCT00286429|147289656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.674|||<|0.001|TWO_SIDED|95.0|1.579|4.53||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||4.530|1.579|<0.001
73873916|NCT00286429|147289656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.819|||<|0.001|TWO_SIDED|95.0|1.653|4.808||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||4.808|1.653|<0.001
73873917|NCT00286429|147289657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.163|||<|0.001|TWO_SIDED|95.0|1.651|6.06||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||6.060|1.651|<0.001
73873918|NCT00286429|147289657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.989|||<|0.001|TWO_SIDED|95.0|2.083|7.64||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||7.640|2.083|<0.001
73955369|NCT02501811|147446068|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.96||0.499|TWO_SIDED|95.0|-1.229|2.635|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.635|-1.229|0.499
73955370|NCT02501811|147446068|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|1.05||0.578|TWO_SIDED|95.0|-0.729|3.485|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.485|-0.729|0.578
74033641|NCT05513391|147620026|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|5.81|||||TWO_SIDED|95.0|-1.99|13.6||||||Statistical analysis for B/Yamagata||13.6|-1.99|
74033642|NCT05513053|147620040|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.98|||||TWO_SIDED|95.0|1.73|2.27||||||Statistical analysis for A/H1N1||2.27|1.73|
74033643|NCT05513053|147620040|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|3.27|||||TWO_SIDED|95.0|2.76|3.87||||||Statistical analysis for A/H3N2||3.87|2.76|
73873919|NCT00286429|147289658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.55||||0.002|TWO_SIDED|95.0|1.732|11.953||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||11.953|1.732|0.002
73873920|NCT00286429|147289658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.74|12.052||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||12.052|1.740|0.002
73873921|NCT00286429|147289660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.291|TWO_SIDED|95.0|-0.81|0.24||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.24|-0.81|0.291
73955371|NCT02501811|147446068|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|1.04||0.523|TWO_SIDED|95.0|-3.552|0.629|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||0.629|-3.552|0.523
73955372|NCT02501811|147446068|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.95||0.471|TWO_SIDED|95.0|-2.7|1.127|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.127|-2.7|0.471
73955373|NCT02501811|147446068|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.95||0.485|TWO_SIDED|95.0|-1.24|2.59|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.590|-1.240|0.485
73955374|NCT02501811|147446069|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|1.05||0.942|TWO_SIDED|95.0|-2.406|1.887|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values|Confidence intervals based on t-test|||1.887|-2.406|0.942
73955375|NCT02501811|147446069|SUPERIORITY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|1.17||0.282|TWO_SIDED|95.0|-1.815|2.975|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.975|-1.815|0.282
73955376|NCT02501811|147446069|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.95||0.163|TWO_SIDED|95.0|-1.31|2.635|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.635|-1.310|0.163
73981901|NCT02991118|147509166|SUPERIORITY||Difference in LS mean|-15.07|STANDARD_ERROR_OF_MEAN|2.641|<|0.001|TWO_SIDED|95.0|-20.26|-9.878|||ANCOVA|||||-9.878|-20.260|<0.001
73981902|NCT00595959|147509167|SUPERIORITY_OR_OTHER|||||||0.001||||||No adjustments|t-test, 1 sided|||Comparing to an expected value of 20% reduction from initial to post-laser||||0.001
73981903|NCT02077374|147509183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.0||||0.0195|TWO_SIDED|95.0|-30.7|-2.5|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in mean change in alanine aminotransferase (ALT) from Baseline to Day28/ET between IDN-6556 and placebo||-2.5|-30.7|0.0195
73955377|NCT02501811|147446069|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.77||0.175|TWO_SIDED|95.0|-2.471|0.628|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.628|-2.471|0.175
73955378|NCT02501811|147446069|SUPERIORITY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|1.03||0.329|TWO_SIDED|95.0|-2.932|1.254|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.254|-2.932|0.329
73981904|NCT02077374|147509185|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.8||||0.8724|TWO_SIDED|95.0|-14.5|11.2|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change in aspartate aminotransferase (AST) from baseline to Day 28/ET between IDN-6556 and placebo||11.2|-14.5|0.8724
73981905|NCT02077374|147509186|SUPERIORITY_OR_OTHER||Median Difference (Net)|-145.0||||0.1149|TWO_SIDED|95.0|-336.0|55.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for cCK18/M30 from Baseline to Day 28/ET between IDN-6556 and Placebo||55|-336|0.1149
73981906|NCT02077374|147509187|SUPERIORITY_OR_OTHER||Median Difference (Net)|-250.0||||0.1365|TWO_SIDED|95.0|-590.0|63.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for caspase 3/7 from Baseline to Day 28/ET between IDN-6556 and Placebo||63|-590|0.1365
73981907|NCT02077374|147509188|SUPERIORITY_OR_OTHER||Median Difference (Net)|-327.0||||0.0471|TWO_SIDED|95.0|-628.0|-7.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis of the difference in the change in full-length cytokeratine 18 (flCK18/M65) from Baseline to Day 28/ET between IDN-6556 and placebo||-7|-628|0.0471
74033644|NCT05513053|147620040|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.57|||||TWO_SIDED|95.0|1.35|1.82||||||Statistical analysis for B/Victoria||1.82|1.35|
74033645|NCT05513053|147620040|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.22|||||TWO_SIDED|95.0|1.09|1.37||||||Statistical analysis for B/Yamagata||1.37|1.09|
73955379|NCT02501811|147446069|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.93||0.752|TWO_SIDED|95.0|-1.829|1.994|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.994|-1.829|0.752
73955380|NCT02501811|147446070|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.75||0.733|TWO_SIDED|95.0|-1.118|1.927|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.927|-1.118|0.733
73955381|NCT02501811|147446070|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.81||0.735|TWO_SIDED|95.0|-1.248|2.041|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.041|-1.248|0.735
73955382|NCT02501811|147446070|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.8||0.794|TWO_SIDED|95.0|-1.464|1.767|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.767|-1.464|0.794
73955383|NCT02501811|147446070|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.7||0.951|TWO_SIDED|95.0|-1.161|1.666|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.666|-1.161|0.951
73955384|NCT02501811|147446070|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.71||0.962|TWO_SIDED|95.0|-1.441|1.457|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.457|-1.441|0.962
73955385|NCT02501811|147446070|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.76||0.945|TWO_SIDED|95.0|-1.793|1.303|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.303|-1.793|0.945
73955386|NCT02501811|147446071|SUPERIORITY||Mean Difference (Final Values)|-2.02|STANDARD_ERROR_OF_MEAN|3.85||0.602|TWO_SIDED|95.0|-9.754|5.711|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||5.711|-9.754|0.602
73955387|NCT02501811|147446071|SUPERIORITY||Mean Difference (Final Values)|-2.78|STANDARD_ERROR_OF_MEAN|3.39||0.443|TWO_SIDED|95.0|-9.609|4.044|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.044|-9.609|0.443
73955388|NCT02501811|147446071|SUPERIORITY||Mean Difference (Net)|-4.13|STANDARD_ERROR_OF_MEAN|3.42||0.348|TWO_SIDED|95.0|-11.011|2.76|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.760|-11.011|0.348
73955389|NCT02501811|147446071|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|3.92||0.812|TWO_SIDED|95.0|-5.76|9.968|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||9.968|-5.760|0.812
73955390|NCT02501811|147446071|SUPERIORITY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|3.89||0.9|TWO_SIDED|95.0|-7.052|8.574|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.574|-7.052|0.900
73955391|NCT02501811|147446071|SUPERIORITY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|3.47||0.848|TWO_SIDED|95.0|-8.321|5.635|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||5.635|-8.321|0.848
73955392|NCT02501811|147446072|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|3.01||0.659|TWO_SIDED|95.0|-7.281|4.789|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.789|-7.281|0.659
73955393|NCT02501811|147446072|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|3.06||0.466|TWO_SIDED|95.0|-8.621|3.71|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||3.710|-8.621|0.466
73955394|NCT02501811|147446072|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|3.08||0.293|TWO_SIDED|95.0|-10.799|1.594|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.594|-10.799|0.293
73955395|NCT02501811|147446072|SUPERIORITY||Mean Difference (Final Values)|3.36|STANDARD_ERROR_OF_MEAN|3.06||0.53|TWO_SIDED|95.0|-2.795|9.508|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||9.508|-2.795|0.530
73955396|NCT02501811|147446072|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|3.05||0.761|TWO_SIDED|95.0|-4.91|7.33|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||7.330|-4.910|0.761
73955397|NCT02501811|147446072|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|3.12||0.669|TWO_SIDED|95.0|-8.426|4.132|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.132|-8.426|0.669
73955398|NCT02501811|147446073|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.989|TWO_SIDED|95.0|-0.048|0.04|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.040|-0.048|0.989
73955399|NCT02501811|147446073|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.493|TWO_SIDED|95.0|-0.056|0.033|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.033|-0.056|0.493
73955400|NCT02501811|147446073|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.926|TWO_SIDED|95.0|-0.053|0.039|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.039|-0.053|0.926
73955401|NCT02501811|147446073|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.904|TWO_SIDED|95.0|-0.041|0.047|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.047|-0.041|0.904
73955402|NCT02501811|147446073|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.476|TWO_SIDED|95.0|-0.035|0.049|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.049|-0.035|0.476
73955403|NCT02501811|147446073|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.515|TWO_SIDED|95.0|-0.04|0.048|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.048|-0.040|0.515
73955404|NCT02501811|147446074|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.85||0.569|TWO_SIDED|95.0|-1.77|1.687|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.687|-1.770|0.569
73955405|NCT02501811|147446074|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.8||0.767|TWO_SIDED|95.0|-1.792|1.457|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.457|-1.792|0.767
73955406|NCT02501811|147446074|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.71||0.261|TWO_SIDED|95.0|-1.965|0.921|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.921|-1.965|0.261
73955407|NCT02501811|147446074|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.86||0.587|TWO_SIDED|95.0|-1.261|2.222|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.222|-1.261|0.587
73955408|NCT02501811|147446074|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.93||0.994|TWO_SIDED|95.0|-1.763|2.014|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.014|-1.763|0.994
73955409|NCT02501811|147446074|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.81||0.639|TWO_SIDED|95.0|-1.993|1.283|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.283|-1.993|0.639
73955410|NCT02501811|147446075|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.42||0.992|TWO_SIDED|95.0|-2.437|3.319|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.319|-2.437|0.992
73955411|NCT02501811|147446075|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.22||0.862|TWO_SIDED|95.0|-2.278|2.643|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.643|-2.278|0.862
73955412|NCT02501811|147446075|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|1.31||0.217|TWO_SIDED|95.0|-3.846|1.443|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.443|-3.846|0.217
73955413|NCT02501811|147446075|SUPERIORITY||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.47||0.327|TWO_SIDED|95.0|-1.325|4.611|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||4.611|-1.325|0.327
73955414|NCT02501811|147446075|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.39||0.859|TWO_SIDED|95.0|-2.551|3.068|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.068|-2.551|0.859
73955415|NCT02501811|147446075|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.27||0.338|TWO_SIDED|95.0|-3.952|1.184|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.184|-3.952|0.338
73955416|NCT02501811|147446076|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.71||0.157|TWO_SIDED|95.0|-2.456|0.411|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.411|-2.456|0.157
73955417|NCT02501811|147446076|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.9||0.428|TWO_SIDED|95.0|-2.798|0.859|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.859|-2.798|0.428
73955418|NCT02501811|147446076|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.73||0.382|TWO_SIDED|95.0|-0.83|2.093|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.093|-0.83|0.382
73955419|NCT02501811|147446076|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.8||0.056|TWO_SIDED|95.0|-3.255|-0.052|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-0.052|-3.255|0.056
73955420|NCT02501811|147446076|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.96||0.61|TWO_SIDED|95.0|-1.991|1.885|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.885|-1.991|0.610
73955421|NCT02501811|147446076|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.97||0.195|TWO_SIDED|95.0|-0.356|3.557|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||3.557|-0.356|0.195
73955422|NCT02501811|147446077|SUPERIORITY||Mean Difference (Final Values)|18.57|STANDARD_ERROR_OF_MEAN|19.01||0.348|TWO_SIDED|95.0|-19.537|56.687|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||56.687|-19.537|0.348
73955423|NCT02501811|147446077|SUPERIORITY||Mean Difference (Final Values)|23.19|STANDARD_ERROR_OF_MEAN|17.88||0.23|TWO_SIDED|95.0|-12.759|59.134|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||59.134|-12.759|0.230
73955424|NCT02501811|147446077|SUPERIORITY||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|16.21||0.905|TWO_SIDED|95.0|-30.974|34.361|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||34.361|-30.974|0.905
73955425|NCT02501811|147446077|SUPERIORITY||Mean Difference (Final Values)|16.88|STANDARD_ERROR_OF_MEAN|15.98||0.335|TWO_SIDED|95.0|-15.267|49.03|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||49.030|-15.267|0.335
73955426|NCT02501811|147446077|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|17.68||0.827|TWO_SIDED|95.0|-40.106|30.88|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||30.880|-40.106|0.827
73955427|NCT02501811|147446077|SUPERIORITY||Mean Difference (Final Values)|-21.49|STANDARD_ERROR_OF_MEAN|14.63||0.163|TWO_SIDED|95.0|-50.989|8.001|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.001|-50.989|0.163
73955428|NCT02501811|147446078|SUPERIORITY||Mean Difference (Final Values)|-9.64|STANDARD_ERROR_OF_MEAN|4.63||0.023|TWO_SIDED|95.0|-18.915|-0.357|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-0.357|-18.915|0.023
73955429|NCT02501811|147446078|SUPERIORITY||Mean Difference (Final Values)|-15.09|STANDARD_ERROR_OF_MEAN|5.84||0.05|TWO_SIDED|95.0|-26.871|-3.319|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-3.319|-26.871|0.050
73955430|NCT02501811|147446078|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|5.86||0.119|TWO_SIDED|95.0|-14.784|8.836|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.836|-14.784|0.119
73955431|NCT02501811|147446078|SUPERIORITY||Mean Difference (Final Values)|-6.66|STANDARD_ERROR_OF_MEAN|5.66||0.845|TWO_SIDED|95.0|-18.087|4.762|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.762|-18.087|0.845
73955432|NCT02501811|147446078|SUPERIORITY||Mean Difference (Final Values)|5.46|STANDARD_ERROR_OF_MEAN|5.64||0.976|TWO_SIDED|95.0|-5.931|16.848|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||16.848|-5.931|0.976
73981908|NCT00424476|147509195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0006||95.0|1.3|2.59||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: \<2g vs ≥2g per 24hr; Race: African/indig-American vs Other)||||2.59|1.30|0.0006
73981909|NCT00424476|147509195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.0129|TWO_SIDED|95.0|1.1|2.19||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05).|Regression, Logistic|Adjusted for baseline stratification factors.||||2.19|1.10|0.0129
73981910|NCT00424476|147509196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.0024|TWO_SIDED|95.0|1.21|2.41|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.41|1.21|0.0024
74033646|NCT05513053|147620041|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|1.92|||||TWO_SIDED|95.0|-2.78|6.62||||||Statistical analysis for A/H1N1||6.62|-2.78|
73955433|NCT02501811|147446078|SUPERIORITY||Mean Difference (Final Values)|12.12|STANDARD_ERROR_OF_MEAN|6.69||0.717|TWO_SIDED|95.0|-1.337|25.578|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||25.578|-1.337|0.717
73955434|NCT02501811|147446079|SUPERIORITY||Mean Difference (Final Values)|-1411.7|STANDARD_ERROR_OF_MEAN|840.6||0.11|TWO_SIDED|95.0|-3108.3|284.9|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||284.9|-3108.3|0.110
73955435|NCT02501811|147446079|SUPERIORITY||Mean Difference (Final Values)|-634.6|STANDARD_ERROR_OF_MEAN|405.1||0.112|TWO_SIDED|95.0|-1460.7|191.4|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||191.4|-1460.7|0.112
73955436|NCT02501811|147446079|SUPERIORITY||Mean Difference (Final Values)|-483.2|STANDARD_ERROR_OF_MEAN|400.7||0.891|TWO_SIDED|95.0|-1301.5|335.2|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||335.2|-1301.5|0.891
73955437|NCT02501811|147446079|SUPERIORITY||Mean Difference (Final Values)|-928.6|STANDARD_ERROR_OF_MEAN|754.2||0.009|TWO_SIDED|95.0|-2470.7|613.6|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||613.6|-2470.7|0.009
73981911|NCT00424476|147509196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0189|TWO_SIDED|95.0|1.07|2.14|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.14|1.07|0.0189
73981912|NCT00424476|147509197|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.||||||0.0003
73981913|NCT00424476|147509197|SUPERIORITY_OR_OTHER|||||||0.2712||95.0|||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.||||||0.2712
73981914|NCT00424476|147509198|SUPERIORITY_OR_OTHER|||||||0.887|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.||||||0.8870
73981915|NCT00424476|147509198|SUPERIORITY_OR_OTHER|||||||0.8127|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.||||||0.8127
73981916|NCT00424476|147509199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0526|TWO_SIDED|95.0|0.99|3.08|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.||||3.08|0.99|0.0526
74033647|NCT05513053|147620041|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|-0.59|||||TWO_SIDED|95.0|-4.41|3.23||||||Statistical analysis for A/H3N2||3.23|-4.41|
74033648|NCT05513053|147620041|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|3.29|||||TWO_SIDED|95.0|-1.57|8.14||||||Statistical analysis for B/Victoria||8.14|-1.57|
74033649|NCT05513053|147620041|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|14.3|||||TWO_SIDED|95.0|9.17|19.3||||||Statistical analysis for B/Yamagata||19.3|9.17|
74033650|NCT03050359|147620050|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|0.4|||||TWO_SIDED|95.0|-2.998|3.791||||||||3.791|-2.998|
73955438|NCT02501811|147446079|SUPERIORITY||Mean Difference (Final Values)|-777.1|STANDARD_ERROR_OF_MEAN|756.5||0.661|TWO_SIDED|95.0|-2323.2|769.1|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||769.1|-2323.2|0.661
73981917|NCT00424476|147509199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0252|TWO_SIDED|95.0|1.08|3.31|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.||||3.31|1.08|0.0252
73981918|NCT00657709|147509201|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||TWO_SIDED|95.0|0.81|0.99|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||0.99|0.81|
73981919|NCT00657709|147509201|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.02|||||TWO_SIDED|95.0|0.93|1.13|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.93|
73981920|NCT00657709|147509201|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.14|||||TWO_SIDED|95.0|1.03|1.27|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.27|1.03|
73955439|NCT02501811|147446079|SUPERIORITY||Mean Difference (Final Values)|151.5|STANDARD_ERROR_OF_MEAN|162.2||0.015|TWO_SIDED|95.0|-175.4|478.4|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||478.4|-175.4|0.015
73955440|NCT02501811|147446080|OTHER||slope of time|0.267|STANDARD_ERROR_OF_MEAN|0.241||0.269|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported||||0.269
73955441|NCT02501811|147446081|OTHER||slope of time|0.141|STANDARD_ERROR_OF_MEAN|0.153||0.361|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.361
73981921|NCT00657709|147509201|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.88|||||TWO_SIDED|95.0|0.78|0.98|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||0.98|0.78|
73981922|NCT00657709|147509201|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.99|||||TWO_SIDED|95.0|0.88|1.1|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.1|0.88|
74033651|NCT03050359|147620051|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-10%, the HP eradication rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|4.7|||||TWO_SIDED|95.0|-1.281|10.69||||||||10.690|-1.281|
74033652|NCT03050359|147620052|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|0.7|||||TWO_SIDED|95.0|-4.901|6.319||||||||6.319|-4.901|
73955442|NCT02501811|147446082|OTHER||slope of time|-0.267|STANDARD_ERROR_OF_MEAN|0.164||0.107|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.107
74033653|NCT03050359|147620053|OTHER||Difference in percentages|-4.1|||||TWO_SIDED|95.0|-15.579|7.344||||||Epigastric Pain (Postprandial)||7.344|-15.579|
73955443|NCT02501811|147446083|OTHER||slope of time|1.395|STANDARD_ERROR_OF_MEAN|0.829||0.095|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.095
73955444|NCT02501811|147446084|OTHER||slope of time|0.603|STANDARD_ERROR_OF_MEAN|0.683||0.379|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.379
73955445|NCT02501811|147446085|OTHER||slope of time|0.003|STANDARD_ERROR_OF_MEAN|0.004||0.401|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.401
73955446|NCT02501811|147446086|OTHER||slope of time|-0.244|STANDARD_ERROR_OF_MEAN|0.158||0.126|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.126
73955447|NCT02501811|147446087|OTHER||slope of time|-0.42|STANDARD_ERROR_OF_MEAN|0.281||0.139|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.139
73955448|NCT02501811|147446088|OTHER||slope of time|-0.133|STANDARD_ERROR_OF_MEAN|0.184||0.472|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.472
74033654|NCT03050359|147620053|OTHER||Difference in percentages|1.6|||||TWO_SIDED|95.0|-5.23|8.422||||||Epigastric Pain (Fasting/Nocturnal)||8.422|-5.230|
74033655|NCT03050359|147620053|OTHER||Difference in percentages|-4.0|||||TWO_SIDED|95.0|-17.338|9.401||||||Abdominal Bloating||9.401|-17.338|
74033656|NCT03050359|147620053|OTHER||Difference in percentages|-9.3|||||TWO_SIDED|95.0|-26.334|7.815||||||Nausea/Vomiting||7.815|-26.334|
73955449|NCT02501811|147446089|OTHER||slope of time|6.544|STANDARD_ERROR_OF_MEAN|2.882||0.025|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.025
73955450|NCT02501811|147446090|OTHER||slope with interaction|-7.08|STANDARD_ERROR_OF_MEAN|3.3||0.037|TWO_SIDED||||||Regression, Linear|||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. A time by treatment interaction was assessed.||||0.037
73955451|NCT02501811|147446090|OTHER||slope with interaction|-6.78|STANDARD_ERROR_OF_MEAN|3.18||0.035|TWO_SIDED||||||Regression, Linear|||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. A time by treatment interaction was assessed.||||0.035
73955452|NCT02501811|147446091|OTHER||slope of time|84.557|STANDARD_ERROR_OF_MEAN|35.81||0.092|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.092
73955453|NCT02624778|147446108|SUPERIORITY||LS Mean|-0.071|STANDARD_ERROR_OF_MEAN|0.07||0.309|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|||||0.07|-0.21|0.309
73955454|NCT02624778|147446108|SUPERIORITY||LS Mean|-0.133|STANDARD_ERROR_OF_MEAN|0.07||0.061|TWO_SIDED|95.0|-0.27|0.01|||Mixed Models Analysis|||||0.01|-0.27|0.061
73955455|NCT02624778|147446108|SUPERIORITY||LS Mean|-0.205|STANDARD_ERROR_OF_MEAN|0.1||0.053|TWO_SIDED|95.0|-0.41|0.0|||Mixed Models Analysis|||||0.00|-0.41|0.053
73955456|NCT02624778|147446108|SUPERIORITY||LS Mean|-0.255|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed Models Analysis|||||-0.13|-0.38|<0.001
73955457|NCT02624778|147446108|SUPERIORITY||LS Mean|-0.369|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.51|-0.23|||Mixed Models Analysis|||||-0.23|-0.51|<0.001
73955458|NCT02624778|147446108|SUPERIORITY||LS Mean|-0.329|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.46|-0.2|||Mixed Models Analysis|||||-0.20|-0.46|<0.001
73955459|NCT05541497|147446115|SUPERIORITY||Risk Ratio (RR)|1.51|||||TWO_SIDED|95.0|0.68|3.37||||||||3.37|0.68|
73955460|NCT05541497|147446116|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.59|3.13||||||||3.13|0.59|
73955461|NCT00531479|147446122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.74||||0.0434|TWO_SIDED|95.0|-18.99|1.51||P-value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||The 95% CI was based on using Greenwood's formula for the variance of the KM estimator.|All-cause mortality calculated using the Kaplan-Meier (KM) product limit estimator on Day 42 (Week 6) within each stratum and weighted by the harmonic mean of the sample sizes in the strata. Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables were site of infection and host factors.||1.51|-18.99|0.0434
74033657|NCT03050359|147620053|OTHER||Difference in percentages|4.5|||||TWO_SIDED|95.0|-4.159|13.25||||||Heartburn||13.250|-4.159|
74033658|NCT03050359|147620053|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-21.104|2.922||||||Lack of Appetite||2.922|-21.104|
74033659|NCT02614287|147620054|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73955462|NCT00531479|147446123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.23|||||TWO_SIDED|95.0|-21.6|1.15||P-value for global response was to be reported only if Week 6 mortality was significant.|||95% confidence interval based on the difference in success rates using the normal approximation to the binoial distribution.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||1.15|-21.6|
73955463|NCT00531479|147446124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2611|TWO_SIDED|95.0|-10.77|5.56||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on using Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||5.56|-10.77|0.2611
73955464|NCT00531479|147446125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.18||||0.0383|TWO_SIDED|95.0|-21.44|1.09||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence intervalbased on using Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||1.09|-21.44|0.0383
73955465|NCT00531479|147446126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.24||||0.1029|TWO_SIDED|95.0|-15.9|3.42||P-Value based on a one-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||3.42|-15.9|0.1029
73955466|NCT00531479|147446127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.696||||0.083|TWO_SIDED|95.0|0.46|1.04|||Cox proportional hazards model|||Hazard Ratio: hazard of death in the Voriconazole/Anidulafungin arm relative to the Voriconazole/Placebo arm, adjusted for host factor status and site of infection. Participants who died beyond Day 84 were censored.||1.04|0.46|0.083
73955467|NCT00531479|147446128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.164|TWO_SIDED|95.0|0.4|1.16|||Cox proportional hazards model||95% confidence interval based on Greenwood's formula.|Analysis based on Cox proportional hazards model. Participants who died beyond day 84 were censored.||1.16|0.40|0.164
73955468|NCT05642000|147446129|SUPERIORITY||Odds Ratio, log|0.187|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|95.0|-0.079|0.454|||Mixed Models Analysis|||||0.454|-0.079|
73955469|NCT02501629|147446148|SUPERIORITY||Odds Ratio (OR)|1.23||||0.468|TWO_SIDED|95.0|0.702|2.157||Significance at 0.05.|proportional odds model|factors for treatment group and randomization strata (age and OCS dose); baseline OCS dose and duration of OCS use prior to study were covariates.||The proportional odds ratio (reslizumab/placebo) was estimated from this model, representing the ratio of the odds of a patient outcome being in a higher OCS dose reduction category for reslizumab compared to placebo.||2.157|0.702|0.468
73955470|NCT02501629|147446149|SUPERIORITY||Odds Ratio (OR)|1.45||||0.234|TWO_SIDED|95.0|0.786|2.683||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.683|0.786|0.234
73981923|NCT00657709|147509201|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.12|||||TWO_SIDED|95.0|1.0|1.26|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.26|1.0|
73981924|NCT00657709|147509201|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.04||||||95.0|0.88|1.23|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.23|0.88|
74009181|NCT02774616|147569166|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0019|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Plexa ICD lead until the 6-month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||||0.0019
74033660|NCT02614287|147620058|SUPERIORITY|||||||0.215|||||||Fisher Exact|||TE ADA Positive (TE ADA+)||||.215
73955471|NCT02501629|147446150|SUPERIORITY||Odds Ratio (OR)|1.19||||0.596|TWO_SIDED|95.0|0.631|2.229||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.229|0.631|0.596
74033661|NCT02614287|147620059|SUPERIORITY||LSMean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46||0.6|TWO_SIDED|95.0|-1.76|0.04|||Mixed Models Analysis|||||0.04|-1.76|0.60
73955472|NCT02501629|147446151|SUPERIORITY||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|10.759||0.101|TWO_SIDED|95.0|-38.986|3.494|||mixed model repeated measures (MMRM)||Reslizumab - Placebo|Mixed model repeated measures (MMRM) with fixed effects for treatment, visit, treatment by visit interaction, age group, and OCS dose group, duration of OCS use and baseline value as covariates, and patient as a random effect. Unstructured covariance was assumed for the repeated measures.||3.494|-38.986|0.101
73955473|NCT02501629|147446152|SUPERIORITY||Odds Ratio (OR)|1.36||||0.341|TWO_SIDED|95.0|0.722|2.562||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.562|0.722|0.341
73955474|NCT02501629|147446153|SUPERIORITY||CAE rate ratio|0.82||||0.407|TWO_SIDED|95.0|0.504|1.321|||Negative binomial regression model|Negative binomial regression model adjusted for stratification factors (OCS dose group), age, number of prior exacerbations, and an offset variable.|reslizumab vs placebo|||1.321|0.504|0.407
73955475|NCT02501629|147446154|SUPERIORITY||Odds Ratio (OR)|0.82||||0.628|TWO_SIDED|95.0|0.371|1.818||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||1.818|0.371|0.628
73955476|NCT02004613|147446157|SUPERIORITY||Risk Ratio (RR)|0.91||||0.34|TWO_SIDED|97.8|0.72|1.15|||Regression, Logistic|||Hypothesis: dexmedetomidine would reduce the incidence of postoperative atrial arrhythmias.||1.15|0.72|0.34
73955477|NCT02004613|147446158|SUPERIORITY||Risk Ratio (RR)|1.48||||0.026|TWO_SIDED|97.8|0.99|2.23|||Regression, Logistic|||hypothesis: Dexmedetomidine may reduce the incidence of postoperative delirium.||2.23|0.99|0.026
73981925|NCT00657709|147509201|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.96||||||95.0|0.81|1.13|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.81|
73981926|NCT00657709|147509201|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for for NZ98 /254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.92|||||TWO_SIDED|95.0|0.78|1.08|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||"The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for NZ98~/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0)."||1.08|0.78|
73981927|NCT00657709|147509203|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third vaccination, were entirely within the interval \[-10%, 10%\].||1|-1|
74033662|NCT02614287|147620060|SUPERIORITY||LSMean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.41||0.835|TWO_SIDED|95.0|-0.72|0.89|||Mixed Models Analysis|||||0.89|-0.72|.835
74033663|NCT02614287|147620061|SUPERIORITY||Odds Ratio (OR)|1.467||||0.063|TWO_SIDED|95.0|0.979|2.197|||CPLRM|CPLRM: Categorical pseudo likelihood-based repeated measures model||||2.197|0.979|.063
73955478|NCT02004613|147446159|SUPERIORITY||Risk Ratio (RR)|1.4||||0.14|TWO_SIDED|97.5|0.84|2.34|||Regression, Logistic|||||2.34|0.84|0.14
73955479|NCT02004613|147446160|OTHER||Risk Ratio (RR)|0.87||||0.29|TWO_SIDED|97.5|0.65|1.16|||Regression, Logistic|||||1.16|0.65|0.29
73955480|NCT00810303|147446177|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
73955481|NCT00810303|147446178|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
74033664|NCT02614287|147620062|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.937|TWO_SIDED|95.0|-0.96|1.04|||Mixed Models Analysis|||||1.04|-0.96|.937
74033665|NCT02614287|147620063|SUPERIORITY||LSMean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.073|TWO_SIDED|95.0|-0.4|0.02|||Mixed Models Analysis|||||0.02|-0.40|0.073
74033666|NCT02614287|147620064|SUPERIORITY||LSMean Difference|0.91|STANDARD_ERROR_OF_MEAN|2.82||0.747|TWO_SIDED|95.0|-4.65|6.47|||Mixed Models Analysis|||||6.47|-4.65|.747
74033667|NCT02614287|147620065|SUPERIORITY||LSMean Difference|1.98|STANDARD_ERROR_OF_MEAN|1.55||0.203|TWO_SIDED|95.0|-1.07|5.03|||Mixed Models Analysis|||Total Score||5.03|-1.07|0.203
74033668|NCT02614287|147620065|SUPERIORITY||LSMean Difference|1.85|STANDARD_ERROR_OF_MEAN|1.59||0.247|TWO_SIDED|95.0|-1.29|4.98|||Mixed Models Analysis|||Role Function-Restrictive Domain Score||4.98|-1.29|.247
73873922|NCT00286429|147289660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.439|TWO_SIDED|95.0|-0.74|0.32||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.32|-0.74|0.439
73955482|NCT00810303|147446180|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
74033669|NCT02614287|147620065|SUPERIORITY||LSMean Difference|1.26|STANDARD_ERROR_OF_MEAN|1.49||0.399|TWO_SIDED|95.0|-1.67|4.19|||Mixed Models Analysis|||Role Function-Preventive Domain Score||4.19|-1.67|0.399
73955483|NCT00810303|147446181|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.||||<0.05
73955484|NCT00810303|147446182|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
73981928|NCT00657709|147509203|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
73981929|NCT00657709|147509203|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
73981930|NCT00657709|147509203|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain.|Vaccines Group Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||1|-1|
73981931|NCT00657709|147509203|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
74009182|NCT02774616|147569168|NON_INFERIORITY|This endpoint evaluates the rate of appropriate right ventricular sensing of all patients in which a sensing measurement was performed. The following hypothesis has been defined: Ho: Rate of appropriate sensing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate sensing through 3 months post-implant \> 93.0%|||||<|0.0001||||||A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate sensing is greater than 93.0% in the population.|exact binomial|||||||<0.0001
74033670|NCT02614287|147620065|SUPERIORITY||LSMean Difference|3.09|STANDARD_ERROR_OF_MEAN|1.8||0.88|TWO_SIDED|95.0|-0.46|6.64|||Mixed Models Analysis|||Emotional Function Domain Score||6.64|-0.46|0.88
73955485|NCT00810303|147446182|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.||||<0.05
73955486|NCT00810303|147446183|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
73955487|NCT00810303|147446184|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.||||<0.05
73955488|NCT00810303|147446185|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
73955489|NCT00810303|147446185|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.||||<0.05
73955490|NCT00810303|147446186|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
73955491|NCT00810303|147446186|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
73955492|NCT00810303|147446187|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
73955493|NCT00810303|147446187|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
73981932|NCT00657709|147509203|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
73981933|NCT00657709|147509203|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for NZ98/254 strain.|Percentage group difference|3.0|||||TWO_SIDED|95.0|-2.0|8.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentages of subjects with hSBA titers ≥ 1:5 at 1 month after the third dose, were entirely within the interval \[-10%, 10%\].||8|-2|
73981934|NCT00657709|147509203|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for NZ 98/254 strain.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-6.0|4.0|||Miettinen and Nurminen|The lot-to-lot difference in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1 month after the third dise, were entirely within the interval \[-10%, 10%\].||4|-6|
73981935|NCT00657709|147509203|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided (5% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for NZ98/254 strain.|Percentage group difference|-4.0|||||TWO_SIDED|95.0|-9.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third dose, were entirely within the interval \[-10%, 10%\].||1|-9|
73981936|NCT00657709|147509206|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.84|||||TWO_SIDED|95.0|0.76|0.94|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least squares means of the log10-transformed titers and their associated 95% CIs.||Immunogenicity of the pertussis components (FHA) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.94|0.76|
73981937|NCT00657709|147509206|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.77|||||TWO_SIDED|95.0|0.67|0.89|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least square means of the log10-transformed titers and their associated 95% CIs.||Immunogenicity of the pertussis component (Pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.89|0.67|
73981938|NCT00657709|147509206|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.8|||||TWO_SIDED|95.0|0.71|0.91|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least squares means of the log10-transformed titers and their associated 95% CIS.||Immunogenicity of the pertussis components (PT) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.91|0.71|
74009183|NCT02774616|147569169|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate pacing is greater than 93.0% in the population.|||||<|0.0001|||||||exact binomial|||"This secondary hypothesis evaluates the rate of appropriate right ventricular pacing of all patients in which a pacing measurement was performed. The following hypothesis has been defined:~Ho: Rate of appropriate pacing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate pacing through 3 months post-implant \> 93.0%"||||<0.0001
74009184|NCT00397033|147569171|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.001
73955494|NCT00810303|147446188|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
73955495|NCT00810303|147446188|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
73955496|NCT00810303|147446189|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
73955497|NCT00810303|147446190|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
73955498|NCT00810303|147446191|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
73955499|NCT00810303|147446191|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
73955500|NCT00601640|147446200|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||||||0.022
73955501|NCT03419780|147446240|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73981939|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age,would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.||2|-1|
73981940|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.||1|-12|
73981941|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.||2|-2|
73981942|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-4.0|||||TWO_SIDED|95.0|-9.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.||1|-9|
73955502|NCT03419780|147446241|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
73955503|NCT03419780|147446242|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
73955504|NCT03419780|147446243|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
73955505|NCT03419780|147446244|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
73955506|NCT03419780|147446245|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
73981943|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-5.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 1 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBV-IPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||2|-5|
73955507|NCT03419780|147446246|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
73955508|NCT02775435|147446256|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.45|0.7||Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)|Regression, Cox|||||0.70|0.45|<0.0001
73955509|NCT02775435|147446257|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0008|TWO_SIDED|95.0|0.49|0.85||Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)|Regression, Cox|||||0.85|0.49|0.0008
74009185|NCT00397033|147569171|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.008
73955510|NCT03582956|147446290|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||||||0.525
73955511|NCT03582956|147446291|SUPERIORITY|||||||0.607|||||||t-test, 2 sided|||||||0.607
73955512|NCT03582956|147446292|SUPERIORITY|||||||0.466|||||||t-test, 2 sided|||||||0.466
73955513|NCT03582956|147446293|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||||||0.414
73955514|NCT03852433|147446313|OTHER||Difference in percentages|34.0||||0.0003|TWO_SIDED|95.0|14.6|50.4|||Fisher Exact|||||50.4|14.6|0.0003
73955515|NCT03852433|147446313|OTHER||Difference in percentages|15.3||||0.2631|TWO_SIDED|95.0|-8.2|34.2|||Fisher Exact|||||34.2|-8.2|0.2631
73955516|NCT03852433|147446313|OTHER||Difference in percentages|29.3||||0.0197|TWO_SIDED|95.0|1.8|48.2|||Fisher Exact|||||48.2|1.8|0.0197
73955517|NCT03852433|147446313|OTHER||Difference in percentages|-4.7||||0.7186|TWO_SIDED|95.0|-26.3|11.8|||Fisher Exact|||||11.8|-26.3|0.7186
73955518|NCT03852433|147446313|OTHER||Difference in percentages|14.0||||0.2184|TWO_SIDED|95.0|-5.5|32.7|||Fisher Exact|||||32.7|-5.5|0.2184
73955519|NCT03852433|147446313|OTHER||Difference in percentages|-20.0||||0.0283|TWO_SIDED|95.0|-36.1|-3.5|||Fisher Exact|||||-3.5|-36.1|0.0283
73955520|NCT03852433|147446316|OTHER||Difference in percentages|26.0||||0.0134|TWO_SIDED|95.0|6.0|44.0|||Fisher Exact|||||44.0|6.0|0.0134
73955521|NCT03852433|147446317|OTHER||Difference in percentages|28.0||||0.0049|TWO_SIDED|95.0|8.2|45.1|||Fisher Exact|||||45.1|8.2|0.0049
74089630|NCT00754494|147732033|SUPERIORITY_OR_OTHER|||||||0.651|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.651
73955522|NCT03852433|147446318|OTHER||Difference in percentages|34.0||||0.0003|TWO_SIDED|95.0|14.6|50.4|||Fisher Exact|||||50.4|14.6|0.0003
73955523|NCT03852433|147446318|OTHER||Difference in percentages|1.0||||1|TWO_SIDED|95.0|-22.8|21.4|||Fisher Exact|||||21.4|-22.8|1.0000
73955524|NCT03852433|147446318|OTHER||Difference in percentages|21.0||||0.1265|TWO_SIDED|95.0|-5.3|42.2|||Fisher Exact|||||42.2|-5.3|0.1265
73955525|NCT03852433|147446318|OTHER||Difference in percentages|-13.0||||0.1863|TWO_SIDED|95.0|-35.3|5.4|||Fisher Exact|||||5.4|-35.3|0.1863
73955526|NCT03852433|147446318|OTHER||Difference in percentages|20.0||||0.0601|TWO_SIDED|95.0|1.0|38.2|||Fisher Exact|||||38.2|1.0|0.0601
73955527|NCT03852433|147446318|OTHER||Difference in percentages|-14.0||||0.1247|TWO_SIDED|95.0|-29.9|1.7|||Fisher Exact|||||1.7|-29.9|0.1247
73955528|NCT03852433|147446319|OTHER||Difference in LS Mean|1.56||||0.0717|TWO_SIDED|95.0|-0.14|3.26|||MMRM|||||3.26|-0.14|0.0717
73955529|NCT03852433|147446319|OTHER||Difference in LS Mean|-1.84||||0.1563|TWO_SIDED|95.0|-4.39|0.71|||MMRM|||||0.71|-4.39|0.1563
73955530|NCT03852433|147446319|OTHER||Difference in LS Mean|-1.8||||0.1626|TWO_SIDED|95.0|-4.33|0.73|||MMRM|||||0.73|-4.33|0.1626
73955531|NCT03852433|147446319|OTHER||Difference in LS Mean|-3.34||||0.0099|TWO_SIDED|95.0|-5.87|-0.82|||MMRM|||||-0.82|-5.87|0.0099
73955532|NCT03852433|147446319|OTHER||Difference in LS Mean|0.07||||0.9384|TWO_SIDED|95.0|-1.67|1.81|||MMRM|||||1.81|-1.67|0.9384
73955533|NCT03852433|147446319|OTHER||Difference in LS Mean|-1.49||||0.0875|TWO_SIDED|95.0|-3.2|0.22|||MMRM|||||0.22|-3.20|0.0875
73955534|NCT03852433|147446320|OTHER||Difference in LS Mean|0.15||||0.8645|TWO_SIDED|95.0|-1.54|1.83|||MMRM|||||1.83|-1.54|0.8645
73955535|NCT03852433|147446320|OTHER||Difference in LS Mean|-0.33||||0.7033|TWO_SIDED|95.0|-2.06|1.39|||MMRM|||||1.39|-2.06|0.7033
73955536|NCT03852433|147446320|OTHER||Difference in LS Mean|-0.48||||0.5806|TWO_SIDED|95.0|-2.18|1.23|||MMRM|||||1.23|-2.18|0.5806
73955537|NCT03852433|147446321|OTHER||Difference in LS Mean|-1.68||||0.1103|TWO_SIDED|95.0|-3.75|0.39|||MMRM|||||0.39|-3.75|0.1103
73955538|NCT03852433|147446321|OTHER||Difference in LS Mean|-2.05||||0.1533|TWO_SIDED|95.0|-4.88|0.77|||MMRM|||||0.77|-4.88|0.1533
73955539|NCT03852433|147446321|OTHER||Difference in LS Mean|-2.22||||0.1129|TWO_SIDED|95.0|-4.98|0.53|||MMRM|||||0.53|-4.98|0.1129
73955540|NCT03852433|147446321|OTHER||Difference in LS Mean|-0.58||||0.6753|TWO_SIDED|95.0|-3.34|2.17|||MMRM|||||2.17|-3.34|0.6753
73955541|NCT03852433|147446321|OTHER||Difference in LS Mean|-0.12||||0.9124|TWO_SIDED|95.0|-2.28|2.04|||MMRM|||||2.04|-2.28|0.9124
73955542|NCT03852433|147446321|OTHER||Difference in LS Mean|1.56||||0.1526|TWO_SIDED|95.0|-0.59|3.7|||MMRM|||||3.70|-0.59|0.1526
73955543|NCT02138916|147446360|SUPERIORITY||Rate ratio|0.96||||0.649|TWO_SIDED|95.0|0.8|1.15|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.15|0.8|0.6490
73955544|NCT02138916|147446360|SUPERIORITY||Risk Ratio (RR)|0.83||||0.0525|TWO_SIDED|95.0|0.69|1.0|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.00|0.69|0.0525
73955545|NCT02138916|147446361|SUPERIORITY||Risk Ratio (RR)|1.07||||0.5236|TWO_SIDED|95.0|0.86|1.34|||Negative binomial|Model includes treatment group, region, number of exacerbations in the previous year.||||1.34|0.86|0.5236
73955546|NCT02138916|147446361|SUPERIORITY||Risk Ratio (RR)|1.02||||0.8812|TWO_SIDED|95.0|0.82|1.27|||Negative binomial|Model includes treatment group, EOS cohort, region, number of exacerbations in the previous year.||||1.27|0.82|0.8812
73955547|NCT02138916|147446362|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.755|TWO_SIDED|95.0|-0.035|0.048|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.048|-0.035|0.7550
73955548|NCT02138916|147446362|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.3285|TWO_SIDED|95.0|-0.021|0.062|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.062|-0.021|0.3285
73955549|NCT02138916|147446363|SUPERIORITY||Mean Difference (Final Values)|-1.011||||0.2906|TWO_SIDED|95.0|-2.887|0.865|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.865|-2.887|0.2906
73955550|NCT02138916|147446363|SUPERIORITY||Mean Difference (Final Values)|-2.136||||0.0264|TWO_SIDED|95.0|-4.02|-0.251|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.251|-4.020|0.0264
73955551|NCT02138916|147446364|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.6782|TWO_SIDED|95.0|-1.08|0.7|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.70|-1.08|0.6782
73955552|NCT02138916|147446364|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.0753|TWO_SIDED|95.0|-1.7|0.08|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.08|-1.70|0.0753
73955553|NCT02138916|147446365|SUPERIORITY||Mean Difference (Final Values)|-0.585||||0.0889|TWO_SIDED|95.0|-1.26|0.089|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.089|-1.260|0.0889
73955554|NCT02138916|147446365|SUPERIORITY||Mean Difference (Final Values)|-0.703||||0.0413|TWO_SIDED|95.0|-1.378|-0.028|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.028|-1.378|0.0413
73955555|NCT02138916|147446366|SUPERIORITY||Mean Difference (Final Values)|-0.348||||0.0728|TWO_SIDED|95.0|-0.728|0.032|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.032|-0.728|0.0728
73955556|NCT02138916|147446366|SUPERIORITY||Mean Difference (Final Values)|-0.487||||0.0121|TWO_SIDED|95.0|-0.868|-0.107|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.107|-0.868|0.0121
73955557|NCT02138916|147446367|SUPERIORITY||Mean Difference (Final Values)|-0.041||||0.0235|TWO_SIDED|95.0|-0.077|-0.006|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.006|-0.077|0.0235
73955558|NCT02138916|147446367|SUPERIORITY||Mean Difference (Final Values)|-0.044||||0.0158|TWO_SIDED|95.0|-0.08|-0.008|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.008|-0.080|0.0158
73955559|NCT02138916|147446371|SUPERIORITY||Rate ratio|1.09||||0.408|TWO_SIDED|95.0|0.89|1.34|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.34|0.89|0.4080
73955560|NCT02138916|147446371|SUPERIORITY||Rate ratio|0.98||||0.8688|TWO_SIDED|95.0|0.8|1.21|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.21|0.80|0.8688
73955561|NCT02138916|147446372|SUPERIORITY||Odds Ratio (OR)|0.9||||0.485|TWO_SIDED|95.0|0.66|1.22|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.22|0.66|0.4850
73955562|NCT02138916|147446372|SUPERIORITY||Odds Ratio (OR)|0.89||||0.4489|TWO_SIDED|95.0|0.65|1.21|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.21|0.65|0.4489
73981944|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-11.0|-1.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 2 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBVIPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||-1|-11|
74039503|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.0025|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.28|0.0025
73955563|NCT02138916|147446374|SUPERIORITY||Rate ratio|1.06||||0.7733|TWO_SIDED|95.0|0.73|1.53|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||1.53|0.73|0.7733
73955564|NCT02138916|147446374|SUPERIORITY||Rate ratio|0.58||||0.0114|TWO_SIDED|95.0|0.39|0.89|||Nagative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.89|0.39|0.0114
73955565|NCT02387749|147446386|SUPERIORITY|||||||0.005|||||||Chi-squared, Corrected|||||||0.005
73955566|NCT03184428|147446531|OTHER||||||<|0.05|||||||Spearman's rank-order correlation|Bonferroni adjustment in addition||||||<0.05
73955567|NCT03425539|147446577|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the baseline value, the two stratification factors (sex and enzyme replacement therapy (ERT) treatment status), and the treatment group.|LS Mean difference vs. placebo|0.42||||0.3189|TWO_SIDED|95.0|-0.4|1.23|||ANCOVA|||||1.23|-0.4|0.3189
73955568|NCT03425539|147446578|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the baseline value, the two stratification factors (sex and ERT treatment status), and the treatment group.|LS Mean difference vs. placebo|-873.53|||<|0.0001|TWO_SIDED|95.0|-1097.53|-649.53|||ANCOVA|||||-649.53|-1097.53|<0.0001
73955569|NCT03425539|147446579|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the terms value, the two stratification factors (sex and ERT treatment status), and the treatment group.|LS Mean difference vs. placebo|0.31||||0.4676|TWO_SIDED|95.0|-0.53|1.16|||ANCOVA|||||1.16|-0.53|0.4676
73955570|NCT03425539|147446580|OTHER||Win ratio|1.0||||0.8986|TWO_SIDED|95.0|0.57|1.89|||ANCOVA|||The p-value was derived from a rank ANCOVA adjusted for the baseline value and stratified by sex and ERT treatment status.||1.89|0.57|0.8986
73955571|NCT01474538|147446643|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% confidence interval (CI) was below 0.4%, lispro was declared non-inferior to aspart.|LS Mean difference|0.1|||||TWO_SIDED|95.0|-0.002|0.21|||Mixed Models Analysis|||||0.210|-0.002|
73955572|NCT01474538|147446644|SUPERIORITY_OR_OTHER||LS Mean difference|-0.28|||||TWO_SIDED|95.0|-2.92|2.35|||Mixed Models Analysis|||||2.35|-2.92|
73955573|NCT01474538|147446645|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.94||||0.522|||||||Negative binomial|||||||0.522
73955574|NCT01474538|147446646|SUPERIORITY_OR_OTHER||LS Mean difference|-0.58||||0.216|||||||Grizzle Model|||||||0.216
73955575|NCT01474538|147446647|SUPERIORITY_OR_OTHER|||||||0.471|||||||Prescott test|||||||0.471
73981945|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 3 of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2,4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||2|-4|
74089631|NCT00754494|147732033|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.030
73955576|NCT05349864|147446664|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|120.25|||||TWO_SIDED|90.0|109.76|131.75||||||||131.75|109.76|
73981946|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||TWO_SIDED|95.0|-5.0|-1.0|||Miettinen and Nurminen|||Immunogenicity of the hepatitis B surface antigen component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT ≥10.0 mIU/ml was greater than -10%||-1|-5|
73981947|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferiority that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥0.15 μg/mL was greater than -10%.||1|-3|
73981948|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|0.0|||||TWO_SIDED|95.0|-7.0|7.0|||Miettinen and Nurminen|||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥1.0 μg/mL was greater than -10%.||7|-7|
73981949|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||TWO_SIDED|95.0|-4.0|0.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% confidence interval for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL was, for the pneumococcal antigen PnC4.||0|-4|
73981950|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|2.0|||||TWO_SIDED|95.0|-4.0|8.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 6B antigen greater than -10%.||8|-4|
73981951|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-2.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa\_HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 9V, greater than -10%.||1|-2|
73981952|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 vaccine when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC14 antigen, greater than -10%.||3|-4|
73981953|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 18C antigen greater than -10%.||1|-3|
73981954|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-3.0|4.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 19F antigen, greater than -10%.||4|-3|
74009186|NCT00397033|147569172|SUPERIORITY_OR_OTHER||LS Means Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-5.1|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.7|-5.1|<0.001
73955577|NCT05349864|147446665|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|116.22|||||TWO_SIDED|90.0|97.91|137.95||||||||137.95|97.91|
73955578|NCT05349864|147446666|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|206.91|||||TWO_SIDED|90.0|171.14|250.15||||||||250.15|171.14|
73955579|NCT05349864|147446667|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed AUClast was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|135.77|||||TWO_SIDED|90.0|114.36|161.19||||||||161.19|114.36|
73955580|NCT05349864|147446668|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed AUCinf was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|138.36|||||TWO_SIDED|90.0|106.11|180.41||||||||180.41|106.11|
73955581|NCT05349864|147446669|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed Cmax was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|236.58|||||TWO_SIDED|90.0|190.12|294.38||||||||294.38|190.12|
73981955|NCT00657709|147509207|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 23F antigen, greater than -10%.||2|-8|
73981956|NCT00657709|147509208|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||Miettinen and Nurminen|||Immunogenicity of the FHA antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||4|-9|
73981957|NCT00657709|147509208|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-9.0|||||TWO_SIDED|95.0|-16.0|-3.0|||Miettinen and Nurminen|||Immunogenicity of the Pertactin antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||-3|-16|
73981958|NCT00657709|147509208|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-2.0|||||TWO_SIDED|95.0|-7.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the PT antigen of DTPa-HBV-IPV vaccine given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||2|-7|
73981959|NCT00872339|147509212|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
73981960|NCT00872339|147509214|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<.001
73981961|NCT00946998|147509234|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
73981962|NCT00946998|147509235|SUPERIORITY|||||||0.28||||||Represents the response outcome.|Mixed Models Analysis|||||||0.28
74033671|NCT01520324|147620070|OTHER|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.||||||||||||||||The number of detected neoplasiae for each patient was listed and summarised by descriptive statistics. Number and percentage of patients with intraepithelial neoplasiae was presented|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.|||
73981963|NCT00946998|147509235|SUPERIORITY|||||||0.86||||||Represents remission outcome.|Mixed Models Analysis|||||||0.86
73981964|NCT00946998|147509236|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
73981965|NCT00946998|147509237|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
73981966|NCT00946998|147509238|SUPERIORITY||||||>|0.99||||||For death|Chi-squared|||||||>.99
73981967|NCT00946998|147509238|SUPERIORITY|||||||0.77||||||For comparison of dialysis initiation between groups.|Chi-squared|||||||0.77
73981968|NCT00946998|147509238|SUPERIORITY||||||>|0.99||||||Hospitalization other than dialysis initiation|Chi-squared|||||||>0.99
73981969|NCT00946998|147509238|SUPERIORITY|||||||0.5||||||For comparison of acute suicidal intent.|Chi-squared|||||||0.5
73981970|NCT00946998|147509238|SUPERIORITY||||||>|0.99||||||For comparison of bleeding requiring blood transfusion or hospitalization.|Chi-squared|||||||>0.99
73981971|NCT00507429|147509307|SUPERIORITY_OR_OTHER|||||||0.223|||||||Log Rank|||||||0.223
74033672|NCT02658994|147620082|SUPERIORITY||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|95.0|-0.33|0.07||||||||0.07|-0.33|
73955582|NCT00984282|147446682|SUPERIORITY_OR_OTHER||||||<|0.0001||||||stratified by age group (\< 60 years, \>= 60 years) and region (Europe, North-America, Asia)|Log Rank|||The two treatment groups were compared using a stratified one-sided log rank test with an overall alpha of 0.01 stratified by age group and region. The null hypothesis that both treatment arms have the same PFS distribution will be tested against the alternative hypothesis that the distribution of PFS times in the sorafenib arm is different from the control arm according to the Lehmann alternative, which is equivalent to the assumption of proportional hazards of the treatment arms.||||<0.0001
73955583|NCT00984282|147446682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.587|||||TWO_SIDED|95.0|0.454|0.758|||Regression, Cox|stratified by age group and region||||0.758|0.454|
73955584|NCT00984282|147446683|SUPERIORITY_OR_OTHER|||||||0.2892|||||||Log Rank|stratified by age group and region||||||0.2892
73955585|NCT00984282|147446683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928|||||TWO_SIDED|95.0|0.713|1.208|||Regression, Cox|stratified by age group and region||||1.208|0.713|
73955586|NCT00984282|147446684|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|stratified by age group and region||||||<0.0001
73955587|NCT00984282|147446684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.557|||||TWO_SIDED|95.0|0.429|0.724|||Regression, Cox|stratified by age group and region||||0.724|0.429|
73981972|NCT00476151|147509397|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED|95.0|||||ANCOVA|||||||0.083
73981973|NCT04332991|147509413|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.73|1.42|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group.|Outcome measure was adjusted for age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization.||1.42|0.73|
73981974|NCT04332991|147509414|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.9|1.81|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.81|0.90|
73981975|NCT04332991|147509415|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.84|1.61|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.61|0.84|
73981976|NCT04332991|147509416|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.69|1.38|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure is adjusted for : age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization.||1.38|0.69|
73981977|NCT04332991|147509417|SUPERIORITY||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.68|3.57|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.57|0.68|
73981978|NCT04332991|147509418|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.54|2.09|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.09|0.54|
73955588|NCT00984282|147446685|SUPERIORITY_OR_OTHER||Difference of response rates|11.7||||0.0015|TWO_SIDED|95.0|3.9|19.4||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of disease control rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region|||19.4|3.9|0.0015
73955589|NCT00984282|147446686|SUPERIORITY_OR_OTHER||Difference in response rate|11.8|||<|0.0001|TWO_SIDED|95.0|7.0|16.5||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of response rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region|||16.5|7.0|<0.0001
73955590|NCT02359435|147446700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.016|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73955591|NCT01289119|147446704|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|||<|0.001|TWO_SIDED|95.0|-0.78|-0.37|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c as a covariate.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.37|-0.78|<0.001
73955592|NCT01289119|147446704|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|||<|0.001|TWO_SIDED|95.0|-0.87|-0.51||ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin dose as covariates.|ANCOVA|||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.51|-0.87|<0.001
73955593|NCT01289119|147446704|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.75|-0.28|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.28|-0.75|<0.001
73955594|NCT01704846|147446716|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.47|||||TWO_SIDED|90.0|95.9|105.25|||||Ratio calculated as Test product divided by reference product|||105.25|95.90|
73981979|NCT04332991|147509419|SUPERIORITY||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.6|2.14|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||2.14|0.60|
73981980|NCT04332991|147509420|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.68|1.34|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.34|0.68|
73981981|NCT04332991|147509421|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.76|2.08|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||2.08|0.76|
73981982|NCT04332991|147509422|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.61|1.72|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.72|0.61|
74009187|NCT00397033|147569172|SUPERIORITY_OR_OTHER||LS Means Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.9||0.217||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-2.8|0.217
73955595|NCT01704846|147446717|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|102.99|||||TWO_SIDED|90.0|95.57|110.98|||||Ratio calculated as Test product divided by reference product|||110.98|95.57|
73955596|NCT01704846|147446718|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.54|||||TWO_SIDED|90.0|96.1|105.18|||||Ratio calculated as Test product divided by reference product|||105.18|96.10|
73955597|NCT01704846|147446719|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the adjusted mean ratio was 80 to 125%.|Adjusted Mean Ratio (%)|97.66|||||TWO_SIDED|90.0|91.54|103.78|||||Ratio calculated as Test product divided by reference product|||103.78|91.54|
73955598|NCT01704846|147446720|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.34|||||TWO_SIDED|90.0|98.51|102.2|||||Ratio calculated as Test product divided by reference product|||102.20|98.51|
73955599|NCT01704846|147446721|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|99.66|||||TWO_SIDED|90.0|97.85|101.51|||||Ratio calculated as Test product divided by reference product|||101.51|97.85|
73955600|NCT01704846|147446722|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.2|||||TWO_SIDED|90.0|98.1|102.34|||||Ratio calculated as Test product divided by reference product|||102.34|98.10|
73955601|NCT00530335|147446728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided|||||||<0.001
73955602|NCT00530335|147446728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
73955603|NCT00530335|147446728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Hyperactivity/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
73955604|NCT00530335|147446728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
73955605|NCT00530335|147446729|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided|||||||<0.001
73955606|NCT00530335|147446729|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
73955607|NCT00530335|147446729|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Hyperactive/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
73955608|NCT00530335|147446729|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
73955609|NCT00530335|147446730|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73955610|NCT00530335|147446731|SUPERIORITY_OR_OTHER|||||||0.749||95.0|||||t-test, 2 sided|||||||0.749
73955611|NCT00530335|147446732|SUPERIORITY_OR_OTHER|||||||0.886||95.0|||||t-test, 2 sided|||||||0.886
73955612|NCT00530335|147446734|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for comparing differences in Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||0.005
73955613|NCT00530335|147446734|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for comparing differences in Color Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||<0.001
73955614|NCT00530335|147446734|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for comparing differences in Color-Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||0.003
73955615|NCT00938340|147446748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0|||||Mixed Models Analysis|||||||0.012
73955616|NCT00938340|147446748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.52
73955617|NCT00938340|147446748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.011
73955618|NCT00938340|147446748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.29
73955619|NCT00938340|147446748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.002
73955620|NCT00938340|147446748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.093
73955621|NCT00938340|147446748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.12
73955622|NCT00938340|147446749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
73955623|NCT00938340|147446749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.15
73955624|NCT00938340|147446749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.35
73955625|NCT00938340|147446749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.011
73955626|NCT00938340|147446749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.62
73955627|NCT00938340|147446749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0002
73955628|NCT00938340|147446749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0013
73955629|NCT00938340|147446750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||Main effect of treatment by timepoint|Mixed Models Analysis|||||||0.15
73981983|NCT04332991|147509423|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.84|1.88|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.88|0.84|
73981984|NCT04332991|147509424|SUPERIORITY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.85|1.61|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.61|0.85|
73981985|NCT04332991|147509425|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-1.0|1.8||||||||1.8|-1.0|
73981986|NCT04332991|147509426|SUPERIORITY||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.61|3.02|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.02|0.61|
73981987|NCT04332991|147509427|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.24|2.7|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.70|0.24|
73955630|NCT00938340|147446751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
73955631|NCT00938340|147446752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
73981988|NCT04332991|147509428|SUPERIORITY||Odds Ratio (OR)|2.51|||||TWO_SIDED|95.0|0.78|8.12|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||8.12|0.78|
73981989|NCT04332991|147509429|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.45|1.05|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.05|0.45|
73981990|NCT04332991|147509430|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.24|2.7|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.70|0.24|
73981991|NCT04332991|147509431|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.59|1.59|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.59|0.59|
73981992|NCT04332991|147509432|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.3|1.58|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.58|0.30|
73955632|NCT00938340|147446752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.98
73955633|NCT00938340|147446752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
73955634|NCT00938340|147446752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.11
73955635|NCT00938340|147446752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
73955636|NCT00938340|147446752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.11
73955637|NCT00938340|147446752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.16
73955638|NCT00938340|147446753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
73955639|NCT00938340|147446753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
73955640|NCT00938340|147446753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.62
73955641|NCT00938340|147446753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.14
73981993|NCT04332991|147509433|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.48|3.18|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.18|0.48|
74033673|NCT02658994|147620083|SUPERIORITY||Median Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-1.39|1.19||||||||1.19|-1.39|
73873923|NCT00286429|147289661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.841|TWO_SIDED|95.0|-0.67|0.55||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.55|-0.67|0.841
73873924|NCT00286429|147289661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.556|TWO_SIDED|95.0|-0.8|0.43||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.43|-0.80|0.556
74089632|NCT00754494|147732033|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.261
73955642|NCT00938340|147446753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.002
73955643|NCT00938340|147446753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.22
73955644|NCT00938340|147446753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.074
73955645|NCT00938340|147446754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Mixed Models Analysis|||||||0.53
73955646|NCT00938340|147446755|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73955647|NCT00938340|147446756|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73955648|NCT00938340|147446757|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73955649|NCT00938340|147446758|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73955650|NCT00938340|147446759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Mixed Models Analysis|||||||0.44
73955651|NCT00938340|147446760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Mixed Models Analysis|||||||0.62
73955652|NCT00938340|147446761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|||||||Mixed Models Analysis|||||||0.011
73955653|NCT00938340|147446761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.007
73955654|NCT00938340|147446761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.99
73955655|NCT00938340|147446761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.037
73955656|NCT00938340|147446761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0087||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0087
73955657|NCT00938340|147446761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.64
73955658|NCT00938340|147446761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.043
73955659|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73955660|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.91
73955661|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.21
73955662|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0011
73955663|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0004
73955664|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.11
73955665|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.53
73955666|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.59
73873925|NCT00286429|147289662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.586|TWO_SIDED|95.0|-0.81|0.46||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.46|-0.81|0.586
73873926|NCT00286429|147289662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.404|TWO_SIDED|95.0|-0.91|0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.37|-0.91|0.404
73873927|NCT00286429|147289663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.874|TWO_SIDED|95.0|-0.62|0.72||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.72|-0.62|0.874
73873928|NCT00286429|147289663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.948|TWO_SIDED|95.0|-0.7|0.65||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.65|-0.70|0.948
73873929|NCT01973413|147289664|NON_INFERIORITY_OR_EQUIVALENCE|Significance level of 0.05, 90% power, required 48 nights of OCL and 48 control nights to detect a 20% improvement.|||||=|0.037|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||=0.037
74033674|NCT02658994|147620084|SUPERIORITY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.33|0.09||||||||0.09|-0.33|
73955667|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.31
73955668|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.98
73955669|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.30
73955670|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.91
73955671|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.12
73955672|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.007
73873930|NCT01973413|147289665|SUPERIORITY_OR_OTHER||||||=|0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||=0.340
73955673|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0089
73955674|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.28
73955675|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.62
73955676|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.48
73955677|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||<0.0001
74033675|NCT02658994|147620085|SUPERIORITY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-0.19|0.96||||||Child Bayley scaled receptive score||0.96|-0.19|
74033676|NCT02658994|147620085|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.83|0.9||||||Child Bayley scaled fine motor score||0.90|-0.83|
74033677|NCT02658994|147620086|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.43|1.05||||||||1.05|0.43|
74033678|NCT02658994|147620087|SUPERIORITY||Risk Ratio (RR)|-0.09|||||TWO_SIDED|95.0|-0.32|0.15||||||Length-for-age z-scores||0.15|-0.32|
74033679|NCT02658994|147620087|SUPERIORITY||Risk Ratio (RR)|-0.12|||||TWO_SIDED|95.0|-0.33|0.1||||||Weight-for-age z-scores||0.10|-0.33|
73873931|NCT01746225|147289667|SUPERIORITY|||||||0.12||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||0.12
73873932|NCT01746225|147289667|SUPERIORITY|||||||0.03||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||.03
73873933|NCT01746225|147289667|SUPERIORITY|||||||0.2||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||.20
73873934|NCT03160898|147289681|SUPERIORITY||least squares mean treatment difference|1.61|STANDARD_ERROR_OF_MEAN|1.003||0.1095|TWO_SIDED|95.0|-0.36|3.58|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||"The statistical null hypothesis was as follows: there was no assumed dose-response relationship in percent predicted SVC change from baseline to Week 12 among all three active doses and placebo, expressed as:~H0: -5 x µ placebo - 1 x µ 150 mg twice daily + 3 x µ 300 mg twice daily + 3 x µ 450 mg twice daily = 0 where µ was the mean of the efficacy endpoint for the designated group."||3.58|-0.36|0.1095
73873935|NCT03160898|147289681|SUPERIORITY||Least squares mean difference|1.49|STANDARD_ERROR_OF_MEAN|1.291||0.2501|TWO_SIDED|95.0|-1.05|4.03|||Mixed Models Analysis|||||4.03|-1.05|0.2501
73873936|NCT03160898|147289681|SUPERIORITY||Least squares mean difference|1.84|STANDARD_ERROR_OF_MEAN|1.29||0.1549|TWO_SIDED|95.0|-0.7|4.38|||Mixed Models Analysis|||||4.38|-0.7|0.1549
73873937|NCT03160898|147289681|SUPERIORITY||Least squares mean difference|1.88|STANDARD_ERROR_OF_MEAN|1.274||0.1417|TWO_SIDED|95.0|-0.63|4.38|||Mixed Models Analysis|||||4.38|-0.63|0.1417
73955678|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0003
73955679|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.57
73955680|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.99
73955681|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.71
73873938|NCT03160898|147289681|SUPERIORITY||Least squares mean difference|1.86|STANDARD_ERROR_OF_MEAN|1.115||0.0964|TWO_SIDED|95.0|-0.33|4.05|||Mixed Models Analysis|||||4.05|-0.33|0.0964
73955682|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.62
73955683|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.33
73955684|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.65
73981994|NCT04332991|147509434|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.24|3.96|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.96|0.24|
73873939|NCT03160898|147289682|SUPERIORITY||Least squares mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.335||0.093|TWO_SIDED|95.0|-0.09|1.22|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||||1.22|-0.09|0.0930
73873940|NCT03160898|147289682|SUPERIORITY||Least squares mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.427||0.0087|TWO_SIDED|95.0|0.29|1.97|||Mixed Models Analysis|||||1.97|0.29|0.0087
73873941|NCT03160898|147289682|SUPERIORITY||Least squares mean difference|0.91|STANDARD_ERROR_OF_MEAN|0.43||0.0351|TWO_SIDED|95.0|0.06|1.75|||Mixed Models Analysis|||||1.75|0.06|0.0351
73873942|NCT03160898|147289682|SUPERIORITY||Least squares mean difference|0.59|STANDARD_ERROR_OF_MEAN|0.425||0.1642|TWO_SIDED|95.0|-0.24|1.43|||Mixed Models Analysis|||||1.43|-0.24|0.1642
73873943|NCT03160898|147289682|SUPERIORITY||Least squares mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.371||0.0435|TWO_SIDED|95.0|0.02|1.48|||Mixed Models Analysis|||||1.48|0.02|0.0435
73955685|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.66
73955686|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.30
73955687|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0005
73955688|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0085
73955689|NCT00938340|147446762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.92
73955690|NCT02534896|147446763|SUPERIORITY|||||||0.018|||||||Hochberg and Gatekeeping|||||||0.018
73955691|NCT02534896|147446763|SUPERIORITY|||||||0.007|||||||Hochberg and Gatekeeping|||||||0.007
73955692|NCT02534896|147446764|SUPERIORITY|||||||0.028|||||||Hochberg and Gatekeeping|||||||0.028
73955693|NCT02534896|147446764|SUPERIORITY|||||||0.003|||||||Hochberg and Gatekeeping|||||||0.003
73955694|NCT02534896|147446765|SUPERIORITY|||||||0.96|||||||Hochberg and Gatekeeping|||||||0.960
73955695|NCT02534896|147446765|SUPERIORITY|||||||0.339|||||||Hochberg and Gatekeeping|||||||0.339
73955696|NCT02534896|147446766|SUPERIORITY|||||||0.573|||||||Hochberg and Gatekeeping|||||||0.573
73981995|NCT04332991|147509435|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.73|1.53|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.53|0.73|
73981996|NCT04332991|147509436|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.92|1.89|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.89|0.92|
73981997|NCT04332991|147509437|SUPERIORITY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.21|2.94|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.94|0.21|
73981998|NCT04332991|147509438|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.06|15.74|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||15.74|0.06|
73981999|NCT04332991|147509439|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.69|1.35|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.35|0.69|
73982000|NCT01767376|147509443|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup A between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.19|||||TWO_SIDED|95.0|0.97|1.48|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup A, one month after Nimenrix vaccination.||1.48|0.97|
73982001|NCT01767376|147509443|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup C between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.12|||||TWO_SIDED|95.0|0.85|1.47|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup C, one month after Nimenrix vaccination.||1.47|0.85|
73982002|NCT01767376|147509443|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup W-135 between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.06|||||TWO_SIDED|95.0|0.86|1.32|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup W-135, one month after Nimenrix vaccination.||1.32|0.86|
73982003|NCT01767376|147509443|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup Y between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.27|||||TWO_SIDED|95.0|1.02|1.59|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup Y, one month after Nimenrix vaccination.||1.59|1.02|
73982004|NCT01767376|147509444|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-D concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-2.14|||||TWO_SIDED|95.0|-7.88|3.53||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-diphtheria toxoid (anti-D) antibody concentrations one month after Boostrix vaccination.||3.53|-7.88|
73982005|NCT01767376|147509444|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-T concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-0.44|||||TWO_SIDED|95.0|-2.48|1.26||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-tetanus toxoid (anti-T) antibody concentrations one month after Boostrix vaccination.||1.26|-2.48|
73955697|NCT02534896|147446766|SUPERIORITY|||||||0.374|||||||Hochberg and Gatekeeping|||||||0.374
73955698|NCT02796092|147446767|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Assuming that both methods were equally effective, we did not use this primary outcome to calculate sample size. It was determined using our own retrospective data of patients from the year 2013, comparing the means of the procedure total time with both methods (41.20±4.66 vs 34.99±4.43 minutes). Ten patients in each group were considered enough to detect the above-mentioned differences with a α-error of 0.05 and 80% power, using a two-sided test.||||>0.999
73955699|NCT02796092|147446768|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.3
73955700|NCT02796092|147446769|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
73955701|NCT02796092|147446770|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
73955702|NCT02796092|147446771|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
73955703|NCT02796092|147446772|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73955704|NCT02796092|147446773|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73955705|NCT02796092|147446774|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73955706|NCT02796092|147446775|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73955707|NCT02796092|147446776|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73955708|NCT02796092|147446777|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73955709|NCT02796092|147446778|SUPERIORITY_OR_OTHER|||||||0.0499|||||||Chi-squared|||||||0.0499
73955710|NCT02796092|147446780|SUPERIORITY_OR_OTHER|||||||0.095|||||||Fisher Exact|||||||0.095
73955711|NCT01107626|147446783|SUPERIORITY|||||||0.12|||||||Log Rank|Stratified logrank test||||||0.12
73955712|NCT01107626|147446783|SUPERIORITY|||||||0.28|||||||Log Rank|Stratified logrank test||||||0.28
73955713|NCT03710564|147446799|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.76||0.4537|TWO_SIDED|95.0|-2.1|0.9|||Pairwise ANOVA|||||0.9|-2.1|0.4537
73982006|NCT01767376|147509445|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertussis (PT) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.76|||||TWO_SIDED|95.0|0.66|0.89|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertussis toxoid (PT), one month after Boostrix vaccination.||0.89|0.66|
73982007|NCT01767376|147509445|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the filamentous haemagglutinin (FHA) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.57|||||TWO_SIDED|95.0|0.5|0.65|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against filamentous haemagglutinin (FHA), one month after Boostrix vaccination.||0.65|0.50|
73982008|NCT01767376|147509445|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertactin (PRN) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.72|||||TWO_SIDED|95.0|0.59|0.88|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertactin (PRN), one month after Boostrix vaccination.||0.88|0.59|
73873944|NCT03160898|147289683|SUPERIORITY||Slope difference|0.0276|STANDARD_ERROR_OF_MEAN|0.02734||0.3134|TWO_SIDED|95.0|-0.0261|0.0813|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||||0.0813|-0.0261|0.3134
73955714|NCT00097253|147446825|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Regression, Linear|||Cortisol. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.||||0.83
73873945|NCT03160898|147289683|SUPERIORITY||Least squares mean difference|0.0246||||0.4824|TWO_SIDED|95.0|-0.0442|0.0935|||Mixed Models Analysis|||||0.0935|-0.0442|0.4824
73955715|NCT00097253|147446825|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Mixed Models Analysis|||Epinephrine. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.||||0.16
73955716|NCT00097253|147446825|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||Mixed Models Analysis|||Norepinephrine. Model controlled for Time 1 baseline. Comparing timepoints 4 and 5 for pre versus post stressor, e.g. lemon versus water control; Citrus(5-4)-Water(5-4).||||0.017
73955717|NCT00097253|147446826|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Mixed Models Analysis|||IL-6. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.||||0.10
73955718|NCT00097253|147446826|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Mixed Models Analysis|||IL-10. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.||||0.50
73955719|NCT00097253|147446827|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Mixed Models Analysis|||Repeated-measures mixed effects models were used. Model was fit to the log-transformed data. Analysis applied to odor category, e.g. lavender / lemon / water.||||0.60
73955720|NCT00097253|147446828|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Regression, Linear|||The maximum DTH wheal of days 1-3 (24, 48, or 72 h) was used as the dependent variable for each subject at each visit. Visits for subjects with a maximum DTH wheal of 5mm or less were excluded. A repeated measures linear model was used to evaluate odor and placebo effects.||||0.014
73955721|NCT01219855|147446829|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Z-test cmpared 2 independ. proportions|||||||<0.0001
73955722|NCT01219855|147446830|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Mixed effect model|||||||<0.01
73955723|NCT01219855|147446831|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed effect model|||||||<0.0001
73955724|NCT01219855|147446831|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Mixed effect model|||||||<0.01
73955725|NCT01219855|147446832|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed effect model|||||||<0.0001
73955726|NCT01219855|147446833|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Z-test compared 2 independ. proportions|||||||<0.05
73955727|NCT01219855|147446834|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Z-test compared 2 independ. proportions|||The proportion of subjects achieving a ≥20% decrease in plasma iPTH at EOT was greater in the CTAP101 Capsules 60 and 90 μg groups compared to the corresponding placebo group.||||<0.001
73955728|NCT04807517|147446847|OTHER|Within-group test for 16-week change|||||<|0.001|||||||Regression, Linear|Repeated measures linear regression||||||<0.001
73955729|NCT00601965|147446873|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log rank test = 32.67, df = 3||||||<.001
73955730|NCT00601965|147446874|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|Beta = -0.48, 95% CI = -0.84 to -0.11||||||0.01
73955731|NCT00126113|147446889|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
73955732|NCT00126113|147446890|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Analysis for main effect of group|ANOVA|||||||>0.05
73955733|NCT00126113|147446891|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
73955734|NCT00126113|147446892|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
73955735|NCT00561574|147446895|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
73955736|NCT00561574|147446895|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
73955737|NCT00561574|147446896|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
73955738|NCT00561574|147446896|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
73955739|NCT00561574|147446897|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
73955740|NCT00561574|147446897|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
73982009|NCT04387773|147509457|SUPERIORITY||Mean Difference (Final Values)|2.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||We hypothesized that GOCOVRI would result in an increase of daily activity due to improvement in LID symptoms.||||>.05
73982010|NCT04387773|147509458|SUPERIORITY||Mean Difference (Final Values)|14.98|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||We hypothesized that GOCOVRI would result in an increase of daily activity due to improvement in LID symptoms.||||>.05
73955741|NCT00561574|147446898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3129||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.3129
73955742|NCT00561574|147446898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3154||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.3154
73955743|NCT00561574|147446899|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
73955744|NCT00561574|147446899|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
73955745|NCT00561574|147446900|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
73955746|NCT00561574|147446900|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
73955747|NCT00561574|147446901|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
73955748|NCT00561574|147446901|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0001
73955749|NCT00561574|147446902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0116||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0116
73955750|NCT00561574|147446902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0004
73955751|NCT03860077|147446908|SUPERIORITY|Average cigarettes per day was positively skewed, with a non-normal residual distribution in a mixed model analysis specifying a normal (Gaussian) outcome distribution. Therefore, this outcome was recoded to integers and modeled as a count with a negative binomial distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Risk Ratio (RR)|1.42|STANDARD_ERROR_OF_MEAN|0.21||0.111|TWO_SIDED|95.0|0.92|2.19|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = 0.35.|These are results of a 2-group (VLNC \& NNC) x 2 repeated measures (Baseline \& Week 4) mixed effects model to test the effect of the randomization group (VLNC vs. NNC) on change in cigarette use and alternative tobacco product (ATP) use from Baseline to Week 4. Group (VLNC vs. NNC) is a fixed, between-subjects focal predictor. Timepoint (Baseline vs. Week 4) is a fixed, within-subjects repeated measure. Subject is a random effect, accounting for variability in Baseline cigarette and ATP use.||2.19|0.92|.111
73955752|NCT03860077|147446909|SUPERIORITY||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.93||0.721|TWO_SIDED|95.0|0.11|4.75|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = - 0.34.|This outcome was recoded as a dichotomous outcome with a binary distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.||4.75|.11|.721
73955753|NCT03860077|147446910|SUPERIORITY|Frequencies of non-combustible alternative product use (ATP) were bimodal with peaks at 0 (no use) and 7 (daily use). Therefore, this outcome was recoded as a dichotomous outcome with a binary distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Odds Ratio (OR)|0.57|STANDARD_ERROR_OF_MEAN|0.96||0.564|TWO_SIDED|95.0|0.08|3.99|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = - 0.56.|||3.99|.08|.564
73955754|NCT03860077|147446911|SUPERIORITY||Slope|0.25|STANDARD_ERROR_OF_MEAN|1.56||0.876|TWO_SIDED|95.0|-2.92|3.42|||Mixed Models Analysis|||The study cigarette outcome is modeled with a normal, Gaussian distribution. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group. Baseline in this analysis is average number of usual brand cigarettes at baseline, prior to randomization.||3.42|-2.92|.876
73955755|NCT03860077|147446912|SUPERIORITY|The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Slope|-2166.79|STANDARD_ERROR_OF_MEAN|1753.48||0.226|TWO_SIDED|95.0|-5743.04|1409.47|||Mixed Models Analysis|||||1409.47|-5743.04|.226
73982011|NCT04387773|147509459|SUPERIORITY||Mean Difference (Final Values)|2393.2||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
73982012|NCT04387773|147509460|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.012|TWO_SIDED||||||t-test, 2 sided|||||||0.012
73955756|NCT01779375|147447030|SUPERIORITY||||||>|0.05||||||All analyses were conducted with values on a log scale and re-exponentiated for presentation.|Regression, Linear|Measures of ß-cell response were modeled simultaneously with insulin sensitivity (M/I) using 2-df seemingly unrelated regression models.||Seemingly unrelated regression was used to compare treatment arms on the combination of insulin sensitivity (M/I as calculated from the hyperglycemic clamp) and insulin secretion (steady-state C-peptide and ACPRmax as co-primary; ACPRg as major secondary,). See statistical analysis plan for further details and R code.||||>0.05
73955757|NCT01779375|147447031|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for presentation.||||>0.05
73955758|NCT01779375|147447033|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for display.||||>0.05
73955759|NCT00430677|147447036|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1||||0.746|TWO_SIDED|95.0|0.6|2.03||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||2.03|0.60|0.746
73955760|NCT00430677|147447036|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.6||||0.118|TWO_SIDED|95.0|0.89|2.83||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||2.83|0.89|0.118
73955761|NCT00430677|147447039|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|0.91|1.78|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||1.78|0.91|
73955762|NCT00430677|147447039|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|0.91|1.77|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||1.77|0.91|
73955763|NCT00430677|147447045|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.68|21.3||||||||21.3|0.68|
73955764|NCT00430677|147447045|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.49|1.59||||||||1.59|0.49|
73955765|NCT00430677|147447047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.13|0.19|||ANCOVA||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.|||0.19|-0.13|
73955766|NCT00430677|147447047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.18|0.14|||ANCOVA||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.|||0.14|-0.18|
73955767|NCT00836810|147447087|SUPERIORITY||||||<|0.001||||||A priory test for statistical significance was P\<0.05|t-test, 2 sided|||||||<0.001
73955768|NCT00836810|147447087|SUPERIORITY||||||<|0.001||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.001
73955769|NCT00836810|147447087|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||||||A priori statistical significance set as P\<0.05|t-test, 2 sided|||||||<0.01
73955770|NCT00836810|147447088|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|A priori statistical significance set at P\<0.05||||||<0.001
73955771|NCT00836810|147447088|SUPERIORITY||||||<|0.01||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.01
73955772|NCT00836810|147447088|SUPERIORITY||||||<|0.01||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.01
73955773|NCT00836810|147447089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.023
73955774|NCT00836810|147447089|SUPERIORITY|||||||0.0906||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.0906
73955775|NCT00836810|147447089|SUPERIORITY|||||||0.044||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.044
73955776|NCT00836810|147447090|SUPERIORITY|||||||0.007||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.007
73955777|NCT00836810|147447090|SUPERIORITY|||||||0.002||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.002
73955778|NCT00836810|147447090|SUPERIORITY|||||||0.57||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.57
73955779|NCT00836810|147447091|SUPERIORITY|||||||0.022||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.022
73955780|NCT00836810|147447091|SUPERIORITY|||||||0.002||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.002
73955781|NCT00836810|147447091|SUPERIORITY|||||||0.51||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.51
73955782|NCT00836810|147447092|SUPERIORITY|||||||0.003||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||.003
73955783|NCT00836810|147447092|SUPERIORITY|||||||0.001||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||.001
73955784|NCT00836810|147447092|SUPERIORITY|||||||0.88||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.88
73982013|NCT04387773|147509461|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
73982014|NCT03745651|147509494|SUPERIORITY||Odds Ratio (OR)|8.84|||<|0.0001|TWO_SIDED|95.0|4.125|21.202||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||21.202|4.125|< 0.0001
73982015|NCT03745651|147509494|SUPERIORITY||Odds Ratio (OR)|15.8|||<|0.0001|TWO_SIDED|95.0|7.354|38.061||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||38.061|7.354|< 0.0001
73982016|NCT03745651|147509495|SUPERIORITY||Odds Ratio (OR)|6.84|||<|0.0001|TWO_SIDED|95.0|3.723|13.184||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.184|3.723|< 0.0001
73982017|NCT03745651|147509495|SUPERIORITY||Odds Ratio (OR)|10.67|||<|0.0001|TWO_SIDED|95.0|5.775|20.732||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||20.732|5.775|< 0.0001
73982018|NCT03745651|147509496|SUPERIORITY||Odds Ratio (OR)|4.17|||<|0.0001|TWO_SIDED|95.0|2.045|9.036||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||9.036|2.045|< 0.0001
73982019|NCT03745651|147509496|SUPERIORITY||Odds Ratio (OR)|5.8|||<|0.0001|TWO_SIDED|95.0|2.833|12.657||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||12.657|2.833|< 0.0001
73982020|NCT03745651|147509497|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8553|TWO_SIDED|95.0|0.598|2.094||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||2.094|0.598|0.8553
73982021|NCT03745651|147509497|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2359|TWO_SIDED|95.0|0.805|2.741||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||2.741|0.805|0.2359
73982022|NCT03745651|147509498|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1784|TWO_SIDED|95.0|0.827|3.342||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.342|0.827|0.1784
73873946|NCT03160898|147289683|SUPERIORITY||Least squares mean difference|0.0146||||0.6787|TWO_SIDED|95.0|-0.0544|0.0835|||Mixed Models Analysis|||||0.0835|-0.0544|0.6787
73955785|NCT00389519|147447167|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||two-sided test|ANCOVA|test from contrast statement from full model||"Planned interim efficacy analysis: 80 placebo and 80 high-dose ramipril subjects provided 93% power, alpha=0.032, to detect 5 mmHg difference in primary outcome. SD of 8.5 mmHg assumed. Alpha of 0.032 required for the planned interim efficacy analysis.~If study continued: 450 total subjects would provide 90% power, alpha=0.027, to detect 3 mmHg difference between placebo and combined ramipril dose groups. Alpha of 0.027 required for the final analysis."||||0.044
73955786|NCT00389519|147447168|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||two-sided, unadjusted|ANCOVA|test from contrast statement from full model||||||0.006
73955787|NCT00946192|147447194|OTHER|Least square means||||||0.039|||||||Mixed Models Analysis|||||||0.039
73955788|NCT00946192|147447195|OTHER|||||||0.018|||||||Mixed Models Analysis|||||||0.018
73955789|NCT04159506|147447239|SUPERIORITY||Median Difference (Final Values)|0.63|||<|0.05|TWO_SIDED|||||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.|Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||||||<0.05
73955790|NCT04159506|147447240|SUPERIORITY||Median Difference (Final Values)|0.31|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.||||<0.05
73955791|NCT04159506|147447241|SUPERIORITY||Median Difference (Final Values)|0.67|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.||||<0.05
73955792|NCT00672256|147447277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
73955793|NCT00672256|147447278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
73955794|NCT00672256|147447279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
73955795|NCT00672256|147447280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
73955796|NCT01720043|147447291|SUPERIORITY|||||||0.181|||||||t-test, 2 sided|||Collagen.5.g.ml, 24 hrs||||0.181
73955797|NCT01720043|147447291|SUPERIORITY|||||||0.164|||||||t-test, 2 sided|||Collagen.2.g.ml||||.164
73955798|NCT01720043|147447291|SUPERIORITY|||||||0.132|||||||t-test, 2 sided|||ADP.10.M, 24 hrs||||.132
73955799|NCT01720043|147447291|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||ADP.5.M||||.066
73955800|NCT01720043|147447291|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||ADP.3.M, 24 hrs||||0.268
73955801|NCT01720043|147447291|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml||||0.106
73955802|NCT01720043|147447291|SUPERIORITY|||||||0.625|||||||t-test, 2 sided|||Ristocetin.1.5.mg.ml||||0.625
73955803|NCT01720043|147447291|SUPERIORITY|||||||0.381|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml||||0.381
73955804|NCT01720043|147447291|SUPERIORITY|||||||0.549|||||||t-test, 2 sided|||Collagen.5.g.ml, 48 hrs||||0.549
73955805|NCT01720043|147447291|SUPERIORITY|||||||0.838|||||||t-test, 2 sided|||Collagen.2.g.ml, 48 hrs||||.838
73873947|NCT03160898|147289683|SUPERIORITY||Least squares mean difference|0.0488||||0.1604|TWO_SIDED|95.0|-0.0194|0.1171|||Mixed Models Analysis|||||0.1171|-0.0194|0.1604
73873948|NCT03160898|147289683|SUPERIORITY||Least squares mean difference|0.0317||||0.2966|TWO_SIDED|95.0|-0.0279|0.0913|||Mixed Models Analysis|||||0.0913|-0.0279|0.2966
73873949|NCT02451514|147289691|OTHER||Geometric mean ratio|1.48|||||TWO_SIDED|95.0|1.03|2.12|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||2.12|1.03|
73873950|NCT02451514|147289691|OTHER||Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.67|1.28|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.28|0.67|
73955806|NCT01720043|147447291|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||ADP.10.M||||0.245
73955807|NCT01720043|147447291|SUPERIORITY|||||||0.417|||||||t-test, 2 sided|||ADP.5.M||||0.417
73955808|NCT01720043|147447291|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||ADP.3.M, 48 hrs||||0.770
73955809|NCT01720043|147447291|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml, 48 hrs||||0.614
73955810|NCT01720043|147447291|SUPERIORITY|||||||0.969|||||||t-test, 2 sided|||Ristochetin.1.5.mg.ml||||0.969
73955811|NCT01720043|147447291|SUPERIORITY|||||||0.238|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml, 48 hrs||||0.238
73955812|NCT01149681|147447332|SUPERIORITY|||||||0.2364|||||||Repeated measures analysis|||||||0.2364
73982023|NCT03745651|147509498|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0472|TWO_SIDED|95.0|1.007|4.0||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||4.000|1.007|0.0472
73955813|NCT02002819|147447350|SUPERIORITY||Mean Difference (Net)|0.07||||0.55|TWO_SIDED|95.0|-0.18|0.32|||ANOVA|||||0.32|-0.18|0.55
73982024|NCT03745651|147509508|SUPERIORITY||Least Squares Mean Difference|-31.91|STANDARD_ERROR_OF_MEAN|4.92|<|0.0001|TWO_SIDED|95.0|-41.57|-22.25|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-22.25|-41.57|<0.0001
73982025|NCT03745651|147509508|SUPERIORITY||Least Squares Mean Difference|-35.13|STANDARD_ERROR_OF_MEAN|4.93|<|0.0001|TWO_SIDED|95.0|-44.81|-25.44|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-25.44|-44.81|<0.0001
73982026|NCT03745651|147509508|SUPERIORITY||Least Squares Mean Difference|-44.56|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|95.0|-53.19|-35.92|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-35.92|-53.19|<0.0001
73873951|NCT02451514|147289691|OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|95.0|0.97|1.96|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.96|0.97|
73873952|NCT02451514|147289691|OTHER||Geometric mean ratio|1.98|||||TWO_SIDED|95.0|1.27|3.09|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||3.09|1.27|
73873953|NCT02451514|147289691|OTHER||Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.63|1.37|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||1.37|0.63|
73873954|NCT02451514|147289691|OTHER||Geometric mean ratio|1.84|||||TWO_SIDED|95.0|1.2|2.84|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||2.84|1.20|
73873955|NCT02451514|147289691|OTHER||Geometric mean ratio|1.34|||||TWO_SIDED|95.0|0.96|1.85|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.85|0.96|
73955814|NCT02002819|147447351|SUPERIORITY||Mean Difference (Net)|2.9||||0.14|TWO_SIDED|95.0|-1.0|6.8|||ANOVA|||||6.8|-1.0|0.14
73955815|NCT02002819|147447352|SUPERIORITY||Mean Difference (Net)|-1.0||||0.43|TWO_SIDED|95.0|-3.4|1.5|||ANOVA|||||1.5|-3.4|.43
73955816|NCT02002819|147447353|SUPERIORITY||Mean Difference (Net)|0.1||||0.63|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||||0.4|-0.2|0.63
73955817|NCT02002819|147447354|SUPERIORITY||Mean Difference (Net)|0.1||||0.9|TWO_SIDED|95.0|-1.1|1.3|||ANOVA|||||1.3|-1.1|0.90
73955818|NCT02002819|147447355|SUPERIORITY||Mean Difference (Net)|0.0||||0.8|TWO_SIDED|95.0|-0.3|0.3|||ANOVA|||||0.3|-0.3|0.80
73955819|NCT02002819|147447356|SUPERIORITY||Mean Difference (Net)|-1.0||||0.46|TWO_SIDED|95.0|-3.6|1.7|||ANOVA|||||1.7|-3.6|0.46
73955820|NCT02002819|147447357|SUPERIORITY||Mean Difference (Net)|0.1||||0.4|TWO_SIDED|95.0|-0.9|1.1|||ANOVA|||||1.1|-0.9|0.40
73955821|NCT02002819|147447358|SUPERIORITY||Mean Difference (Net)|7.4||||0.046|TWO_SIDED|95.0|0.2|14.7|||ANOVA|||||14.7|0.2|0.046
73955822|NCT02002819|147447359|SUPERIORITY||Mean Difference (Net)|-2.5||||0.3|TWO_SIDED|95.0|-7.8|2.7|||ANOVA|||||2.7|-7.8|.30
73955823|NCT02002819|147447360|SUPERIORITY||Mean Difference (Net)|3.8||||0.52|TWO_SIDED|95.0|-8.5|16.0|||Cohen f|||||16.0|-8.5|0.52
73955824|NCT02002819|147447361|SUPERIORITY||Mean Difference (Net)|0.7||||0.4|TWO_SIDED|95.0|-1.0|2.4|||ANOVA|||||2.4|-1.0|0.40
73955825|NCT02002819|147447362|SUPERIORITY||Mean Difference (Net)|-0.2||||0.63|TWO_SIDED|95.0|-1.1|0.7|||ANOVA|||||0.7|-1.1|0.63
73955826|NCT02002819|147447364|SUPERIORITY||Mean Difference (Net)|0.8||||0.15|TWO_SIDED|95.0|-0.3|1.8|||ANOVA|||||1.8|-0.3|.15
73955827|NCT02661997|147447374|SUPERIORITY|||||||0.58||||||Between group differences|ANOVA|||||||0.58
73955828|NCT02661997|147447375|SUPERIORITY|||||||0.88|||||||ANOVA|||||||0.88
73955829|NCT02661997|147447376|SUPERIORITY|||||||0.17|||||||ANOVA|||||||0.17
73955830|NCT02661997|147447377|SUPERIORITY|||||||0.88|||||||ANOVA|||This is an analysis of pre to post-treatment changes on the Physical Health subscale of the PROMIS Global Health Scale||||0.88
73955831|NCT02661997|147447378|SUPERIORITY|||||||0.032||||||P-value for group by time interaction|ANOVA|||||||0.032
73955832|NCT02661997|147447379|SUPERIORITY|||||||0.006||||||P-value for group by time interaction|ANOVA|||||||0.006
73955833|NCT02661997|147447380|SUPERIORITY|||||||0.44||||||P-value for group by time interaction|ANOVA|||||||0.44
74033680|NCT00262080|147620112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037||95.0||||no adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|non-parametric Wilcoxon Rank Sum test|||The primary efficacy analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.037
73873956|NCT02451514|147289691|OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|95.0|0.7|1.25|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.25|0.70|
73982027|NCT03745651|147509508|SUPERIORITY||Least Squares Mean Difference|-45.91|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|95.0|-54.55|-37.26|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-37.26|-54.55|<0.0001
73982028|NCT03745651|147509508|SUPERIORITY||Least Squares Mean Difference|-44.53|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-53.08|-35.98|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-35.98|-53.08|<0.0001
73982029|NCT03745651|147509508|SUPERIORITY||Least Squares Mean Difference|-46.0|STANDARD_ERROR_OF_MEAN|4.33|<|0.0001|TWO_SIDED|95.0|-54.51|-37.48|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-37.48|-54.51|<0.0001
73982030|NCT03745651|147509509|SUPERIORITY||Least Squares Mean Difference|-39.4|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001|TWO_SIDED|95.0|-46.48|-32.38|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-32.38|-46.48|<0.0001
73982031|NCT03745651|147509509|SUPERIORITY||Least Squares Mean Difference|-43.5|STANDARD_ERROR_OF_MEAN|3.56|<|0.0001|TWO_SIDED|95.0|-50.51|-36.53|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-36.53|-50.51|<0.0001
73982032|NCT03745651|147509510|SUPERIORITY||Least Squares Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.02|-1.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.01|-2.02|<0.0001
73982033|NCT03745651|147509510|SUPERIORITY||Least Squares Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.24|-1.24|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.24|-2.24|<0.0001
73982034|NCT03745651|147509510|SUPERIORITY||Least Squares Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.36|-1.23|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.23|-2.36|<0.0001
73982035|NCT03745651|147509510|SUPERIORITY||Least Squares Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.53|-1.4|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.40|-2.53|<0.0001
73982036|NCT03745651|147509510|SUPERIORITY||Least Squares Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.49|-1.29|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.29|-2.49|<0.0001
73982037|NCT03745651|147509510|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.10|-2.30|<0.0001
73982038|NCT03745651|147509512|SUPERIORITY||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.94|-0.97|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.97|-1.94|<0.0001
73982039|NCT03745651|147509512|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.72|-0.76|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.76|-1.72|<0.0001
73982040|NCT03745651|147509515|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.57||0.2903|TWO_SIDED|95.0|-1.71|0.51|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||0.51|-1.71|0.2903
73982041|NCT03745651|147509515|SUPERIORITY||Least Squares Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.57||0.0837|TWO_SIDED|95.0|-2.09|0.13|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||0.13|-2.09|0.0837
73982042|NCT03745651|147509515|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.61||0.6272|TWO_SIDED|95.0|-1.5|0.91|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||0.91|-1.50|0.6272
74033681|NCT00262080|147620113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Wilcoxon Rank Sum Test.|||The analysis compared the change from baseline in MSCS score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.044
73873957|NCT02451514|147289691|OTHER||Geometric mean ratio|1.25|||||TWO_SIDED|95.0|0.91|1.72|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.72|0.91|
73955834|NCT02661997|147447381|SUPERIORITY|||||||0.36||||||P-value for group by time interaction|ANOVA|||||||0.36
73955835|NCT02661997|147447382|SUPERIORITY|||||||0.24|||||||ANOVA|||||||0.24
73955836|NCT02661997|147447383|SUPERIORITY|||||||0.55||||||P-value for group by time interaction|ANOVA|||||||0.55
73982043|NCT03745651|147509515|SUPERIORITY||Least Squares Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.61||0.1609|TWO_SIDED|95.0|-2.07|0.34|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||0.34|-2.07|0.1609
73982044|NCT03745651|147509515|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.73||0.3362|TWO_SIDED|95.0|-2.13|0.73|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||0.73|-2.13|0.3362
73982045|NCT03745651|147509515|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.269|TWO_SIDED|95.0|-2.23|0.62|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||0.62|-2.23|0.2690
73982046|NCT03745651|147509516|SUPERIORITY||Least Squares Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.54||0.0482|TWO_SIDED|95.0|-2.13|-0.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.01|-2.13|0.0482
73982047|NCT03745651|147509516|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.54||0.0271|TWO_SIDED|95.0|-2.26|-0.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.14|-2.26|0.0271
73982048|NCT03745651|147509516|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.6||0.2091|TWO_SIDED|95.0|-1.94|0.42|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||0.42|-1.94|0.2091
73982049|NCT03745651|147509516|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.6||0.0111|TWO_SIDED|95.0|-2.71|-0.35|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.35|-2.71|0.0111
73982050|NCT03745651|147509516|SUPERIORITY||Least Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.68||0.0802|TWO_SIDED|95.0|-2.51|0.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||0.14|-2.51|0.0802
73982051|NCT03745651|147509516|SUPERIORITY||Least Squares Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.67||0.0666|TWO_SIDED|95.0|-2.56|0.09|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||0.09|-2.56|0.0666
73982052|NCT03745651|147509519|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.84|-2.97|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.97|-4.84|<0.0001
73982053|NCT03745651|147509519|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-5.47|-3.63|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-3.63|-5.47|<0.0001
73955837|NCT02661997|147447384|SUPERIORITY|||||||0.36||||||P-value for group by time interaction|ANOVA|||||||0.36
74033682|NCT00262080|147620117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||The Log-Rank test was used to compare the time distribution between the two treatment groups.||||0.055
73873958|NCT02451514|147289691|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|95.0|0.81|2.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||2.53|0.81|
73955838|NCT02661997|147447385|SUPERIORITY|||||||0.73||||||P-value for group by time interaction|ANOVA|||||||0.73
73955839|NCT00742274|147447408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73955840|NCT02427737|147447410|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.0001
73955841|NCT02427737|147447410|SUPERIORITY|||||||0.3037||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||0.3037
73955842|NCT02427737|147447410|SUPERIORITY||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.01
73955843|NCT02427737|147447411|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.0001
73955844|NCT02427737|147447411|SUPERIORITY|||||||0.201||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter||||0.2010
73955845|NCT02427737|147447411|SUPERIORITY||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.001
73955846|NCT02427737|147447412|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Comparison among trained and untrained sites||||<0.0001
73982054|NCT03745651|147509521|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-7.38|-4.86|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-4.86|-7.38|<0.0001
73982055|NCT03745651|147509521|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-7.17|-4.67|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-4.67|-7.17|<0.0001
73982056|NCT03745651|147509523|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.19|-2.32|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-2.32|-4.19|<0.0001
73982057|NCT03745651|147509523|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-3.67|-1.83|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-1.83|-3.67|<0.0001
73982058|NCT03745651|147509525|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.55||0.0099|TWO_SIDED|95.0|-7.24|-1.03|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-1.03|-7.24|0.0099
74033683|NCT04009096|147620152|OTHER|||||||0.14||||||Two tailed p value reported for Mann-Whitney test comparing controls with each vaccinees|Wilcoxon (Mann-Whitney)|||Comparison of pooled data from Groups 1, 2 and 3 volunteers who completed CHMI with pooled data of infectivity controls (unvaccinated) from CHMI study running in parallel (VAC069 study)||||0.14
73955847|NCT02427737|147447412|SUPERIORITY|||||||0.303||||||"Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.~Chi-square analysis was used to assess equipment utilization at trained sites compared with untrained sites when stratifying by time (chi-square MH = 858.2)."|Chi-squared|||Change in the quarterly equipment utilization rate as compared to the baseline quarter Q4FY15 over time and at sites||||0.303
73955848|NCT02427737|147447412|SUPERIORITY||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.001
73955849|NCT02427737|147447413|SUPERIORITY||||||<|0.0001||||||CMH test was used with time as a strata variable (rather than pooling all data together as in the regular chi-squared test). The CMH chi-squared value was 858.2, and the regular chi-squared value was 858.8.|Chi-squared, Corrected|Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.||||||<0.0001
73955850|NCT02427737|147447414|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73955851|NCT02427737|147447416|SUPERIORITY|||||||0.2357||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||0.2357
73955852|NCT02427737|147447416|SUPERIORITY|||||||0.8523||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter||||0.8523
73955853|NCT02427737|147447416|SUPERIORITY|||||||0.5883||||||Bonferroni-correction was not done for this nonsignificant result since the corrected p-value would be have been greater than 1, which is not possible.|Chi-squared|||Change in the quarterly average no-show rate as compared to the baseline quarter at untrained sites||||0.5883
73955854|NCT02427737|147447417|SUPERIORITY|||||||0.0195||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||0.0195
73955855|NCT02427737|147447417|SUPERIORITY|||||||0.276||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows compared to the baseline quarter||||0.276
73955856|NCT02427737|147447417|SUPERIORITY|||||||0.2764||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter at untrained sites||||0.2764
73955857|NCT02427737|147447418|SUPERIORITY||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.01
73982059|NCT03745651|147509525|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.59||0.0542|TWO_SIDED|95.0|-6.3|0.06|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||0.06|-6.30|0.0542
73955858|NCT02427737|147447418|SUPERIORITY|||||||0.9012||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the quarterly average no show rate as compared to the baseline quarter for trained sites||||0.9012
73955859|NCT02427737|147447418|SUPERIORITY|||||||0.9065||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the quarterly average no-show rate as compared to the baseline quarter for untrained sites||||0.9065
74033684|NCT05151471|147620157|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
74033685|NCT05151471|147620158|SUPERIORITY|||||||0.704|||||||ANCOVA|||Week 72||||0.704
74033686|NCT05151471|147620158|SUPERIORITY|||||||0.131|||||||ANCOVA|||Week 96||||0.131
74033687|NCT05151471|147620159|SUPERIORITY|||||||0.954|||||||Mixed Model for Repeated Measures (MMRM)|||Week 72||||0.954
74033688|NCT05151471|147620159|SUPERIORITY|||||||0.591|||||||Mixed Model for Repeated Measures (MMRM)|||Week 96||||0.591
74033689|NCT05151471|147620160|SUPERIORITY|||||||0.513|||||||Mixed Model for Repeated Measures (MMRM)|||Week 72||||0.513
74033690|NCT05151471|147620160|SUPERIORITY|||||||0.344|||||||Mixed Model for Repeated Measures (MMRM)|||Week 84||||0.344
74033691|NCT05151471|147620160|SUPERIORITY|||||||0.142|||||||Mixed Model for Repeated Measures (MMRM)|||Week 96||||0.142
73955860|NCT02427737|147447419|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|CMH test with time as a strata variable was 28.7; chi-square value with pooling all data together was 28.6||Comparison among trained and untrained sites over time||||<0.0001
73955861|NCT02427737|147447424|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73955862|NCT02427737|147447425|SUPERIORITY|||||||0.2396|||||||Chi-squared|||||||0.2396
73955863|NCT02427737|147447426|SUPERIORITY|||||||0.5267|||||||Chi-squared|||||||0.5267
73955864|NCT02427737|147447427|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73955865|NCT02427737|147447428|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73955866|NCT00335556|147447430|OTHER||Log Rank Test Statistic|5.419||||0.0199|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage II-IV diffuse anaplastic Wilms' tumor on AREN0321 and NWTS-5 (NCT00002610) were compared using the log-rank test.||||.0199
73955867|NCT00335556|147447431|OTHER||Log Rank Test Statistic|0.8814||||0.3478|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients with Stage I-IV malignant rhabdoid tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.||||.3478
73955868|NCT00335556|147447433|OTHER||Log Rank Test Statistic|3.6216||||0.057|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage I focal and diffuse anaplastic Wilms tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.||||.0570
73955869|NCT00478556|147447437|SUPERIORITY_OR_OTHER||difference in proportions|62.0|||<|0.001|||||||Binomial test of proportion|tested if values were different from 50%||All individuals tasted both preparations and indicated preference. A binomial test of proportion was done to see if these values differed from 50%.||||<0.001
73955870|NCT00478556|147447438|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test was used to assess differences in bowel opacification score between the two groups.||||0.270
73955871|NCT02107014|147447512|SUPERIORITY_OR_OTHER|||||||0.576|||||||Mixed Models Analysis|||||||.576
73955872|NCT02107014|147447513|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.010
73955873|NCT02107014|147447514|SUPERIORITY_OR_OTHER|||||||0.008|||||||Mixed Models Analysis|||||||.008
73955874|NCT02107014|147447515|SUPERIORITY_OR_OTHER|||||||0.015|||||||Mixed Models Analysis|||||||.015
73955875|NCT02107014|147447516|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||.007
73955876|NCT02107014|147447517|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||.016
73955877|NCT02107014|147447518|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73955878|NCT02107014|147447519|SUPERIORITY_OR_OTHER|||||||0.212|||||||Mixed Models Analysis|||||||0.212
73955879|NCT02107014|147447522|SUPERIORITY_OR_OTHER|||||||0.008|||||||Mixed Models Analysis|||||||0.008
73873959|NCT02451514|147289691|OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|95.0|0.49|1.37|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||1.37|0.49|
73955880|NCT02107014|147447523|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
73955881|NCT02107014|147447524|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73955882|NCT02107014|147447525|SUPERIORITY_OR_OTHER|||||||0.047|||||||Mixed Models Analysis|||||||0.047
73955883|NCT02107014|147447526|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
73955884|NCT02107014|147447527|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||||||0.003
73955885|NCT02107014|147447528|SUPERIORITY_OR_OTHER|||||||0.191|||||||Mixed Models Analysis|||||||0.191
73955886|NCT02107014|147447529|SUPERIORITY_OR_OTHER|||||||0.088|||||||Mixed Models Analysis|||||||0.088
73955887|NCT02107014|147447530|SUPERIORITY_OR_OTHER|||||||0.478|||||||Mixed Models Analysis|||||||0.478
73955888|NCT02107014|147447533|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
73955889|NCT02107014|147447534|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||||||0.025
73955890|NCT02107014|147447535|SUPERIORITY_OR_OTHER|||||||0.012|||||||Mixed Models Analysis|||||||0.012
73955891|NCT02107014|147447536|SUPERIORITY_OR_OTHER|||||||0.426|||||||Mixed Models Analysis|||||||0.426
73955892|NCT02107014|147447537|SUPERIORITY_OR_OTHER|||||||0.042|||||||Mixed Models Analysis|||||||0.042
73955893|NCT02107014|147447538|SUPERIORITY_OR_OTHER|||||||0.708|||||||Mixed Models Analysis|||||||0.708
73955894|NCT02107014|147447539|SUPERIORITY_OR_OTHER|||||||0.558|||||||Mixed Models Analysis|||||||0.558
73955895|NCT02107014|147447540|SUPERIORITY_OR_OTHER|||||||0.35|||||||Mixed Models Analysis|||||||0.350
73955896|NCT02107014|147447541|SUPERIORITY_OR_OTHER|||||||0.655|||||||Mixed Models Analysis|||||||0.655
73955897|NCT02107014|147447542|SUPERIORITY_OR_OTHER|||||||0.248|||||||Mixed Models Analysis|||||||0.248
73955898|NCT02107014|147447543|SUPERIORITY_OR_OTHER|||||||0.128|||||||Mixed Models Analysis|||||||0.128
73955899|NCT02107014|147447544|SUPERIORITY_OR_OTHER|||||||0.065|||||||Mixed Models Analysis|||||||0.065
73955900|NCT02107014|147447545|SUPERIORITY_OR_OTHER|||||||0.962|||||||Mixed Models Analysis|||||||0.962
73955901|NCT02107014|147447546|SUPERIORITY_OR_OTHER|||||||0.402|||||||Mixed Models Analysis|||||||0.402
73955902|NCT02107014|147447547|SUPERIORITY_OR_OTHER|||||||0.201|||||||Mixed Models Analysis|||||||0.201
73955903|NCT02107014|147447548|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
73955904|NCT02107014|147447549|SUPERIORITY_OR_OTHER|||||||0.006|||||||Mixed Models Analysis|||||||0.006
73955905|NCT02107014|147447550|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||0.007
73955906|NCT02107014|147447551|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||0.038
73955907|NCT02107014|147447552|SUPERIORITY_OR_OTHER|||||||0.032|||||||Mixed Models Analysis|||||||0.032
73955908|NCT02107014|147447553|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
73955909|NCT02107014|147447555|SUPERIORITY_OR_OTHER|||||||0.508|||||||Mixed Models Analysis|||||||0.508
73955910|NCT02107014|147447556|SUPERIORITY_OR_OTHER|||||||0.119|||||||Mixed Models Analysis|||||||0.119
73955911|NCT02107014|147447557|SUPERIORITY_OR_OTHER|||||||0.326|||||||Mixed Models Analysis|||||||0.326
73955912|NCT02107014|147447558|SUPERIORITY_OR_OTHER|||||||0.753|||||||Mixed Models Analysis|||||||0.753
73955913|NCT02107014|147447559|SUPERIORITY_OR_OTHER|||||||0.067|||||||Mixed Models Analysis|||||||0.067
73982060|NCT03745651|147509529|SUPERIORITY||Odds Ratio (OR)|5.16|||<|0.0001|TWO_SIDED|95.0|2.987|9.049||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||9.049|2.987|<0.0001
73982061|NCT03745651|147509529|SUPERIORITY||Odds Ratio (OR)|7.47|||<|0.0001|TWO_SIDED|95.0|4.23|13.415||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||13.415|4.230|<0.0001
73982062|NCT03745651|147509530|SUPERIORITY||Least Squares Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|1.78||0.015|TWO_SIDED|95.0|0.85|7.86|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||7.86|0.85|0.0150
73982063|NCT03745651|147509530|SUPERIORITY||Least Squares Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|1.77||0.0044|TWO_SIDED|95.0|1.59|8.54|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.54|1.59|0.0044
73982064|NCT03745651|147509531|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|3.81||0.142|TWO_SIDED|95.0|-13.12|1.89|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||1.89|-13.12|0.1420
73982065|NCT03745651|147509531|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|3.82||0.0375|TWO_SIDED|95.0|-15.51|-0.47|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-0.47|-15.51|0.0375
73982066|NCT03745651|147509531|SUPERIORITY||Least Squares Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|2.75||0.0012|TWO_SIDED|95.0|-14.48|-3.63|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-3.63|-14.48|0.0012
73982067|NCT03745651|147509531|SUPERIORITY||Least Squares Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.74||0.0095|TWO_SIDED|95.0|-12.58|-1.77|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-1.77|-12.58|0.0095
73955914|NCT02107014|147447560|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.080
73955915|NCT02107014|147447561|SUPERIORITY_OR_OTHER|||||||0.639|||||||Mixed Models Analysis|||||||0.639
73955916|NCT02107014|147447564|SUPERIORITY_OR_OTHER|||||||0.945|||||||Mixed Models Analysis|||||||0.945
73955917|NCT02107014|147447565|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||0.038
73955918|NCT02107014|147447566|SUPERIORITY_OR_OTHER|||||||0.281|||||||Mixed Models Analysis|||||||0.281
73955919|NCT02107014|147447567|SUPERIORITY_OR_OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.030
73955920|NCT02107014|147447568|SUPERIORITY_OR_OTHER|||||||0.948|||||||Mixed Models Analysis|||||||0.948
73955921|NCT02107014|147447569|SUPERIORITY_OR_OTHER|||||||0.61|||||||Mixed Models Analysis|||||||0.610
73955922|NCT02107014|147447570|SUPERIORITY_OR_OTHER|||||||0.893|||||||Mixed Models Analysis|||||||0.893
73982068|NCT03745651|147509531|SUPERIORITY||Least Squares Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-22.69|-7.73|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.73|-22.69|<0.0001
73982069|NCT03745651|147509531|SUPERIORITY||Least Squares Mean Difference|-12.6|STANDARD_ERROR_OF_MEAN|3.79||0.001|TWO_SIDED|95.0|-20.1|-5.18|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.18|-20.10|0.0010
73982070|NCT03745651|147509531|SUPERIORITY||Least Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-16.18|-7.95|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.95|-16.18|<0.0001
73955923|NCT02107014|147447571|SUPERIORITY_OR_OTHER|||||||0.041|||||||Mixed Models Analysis|||||||0.041
73955924|NCT02107014|147447574|SUPERIORITY_OR_OTHER|||||||0.967|||||||Mixed Models Analysis|||||||0.967
73955925|NCT02107014|147447575|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73955926|NCT02107014|147447576|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73955927|NCT01649427|147447633|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority||||||0.0003|||||||ANCOVA|||||||0.0003
73955928|NCT05822440|147447639|OTHER||Ratio of Adjusted Geometric Means|124.35|||||TWO_SIDED|90.0|100.22|154.29||||||Ratio was between test to reference, where test is PF-07817883 + Itraconazole arm and reference is PF-07817883 arm. Natural log transformed Cmax of PF-07817883 were analyzed using a mixed effect model with treatment as fixed effect and participant as a random effect. The ratios (and 90% CIs) were expressed as percentages.||154.29|100.22|
73955929|NCT05822440|147447640|OTHER||Ratio of Adjusted Geometric Means|212.83||||||90.0|183.76|246.5||||||Ratio was between test to reference, where test is PF-07817883 + Itraconazole arm and reference is PF-07817883 arm. Natural log transformed Cmax of PF-07817883 were analyzed using a mixed effect model with treatment as fixed effect and participant as a random effect. The ratios (and 90% CIs) were expressed as percentages.||246.50|183.76|
73955930|NCT04888585|147447666|SUPERIORITY||Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|11.5|31.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||31.0|11.5|<0.001
74033692|NCT04263142|147620164|OTHER||Ratio|0.998|||||TWO_SIDED|90.0|0.9263|1.0757|||||Analysis was performed using analysis of variance (ANOVA) with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablets/capsules.|||1.0757|0.9263|
74033693|NCT04263142|147620165|OTHER||Ratio|1.002|||||TWO_SIDED|90.0|0.9321|1.0781|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablets/capsules.|||1.0781|0.9321|
73873960|NCT02451514|147289691|OTHER||Geometric mean ratio|1.18|||||TWO_SIDED|95.0|0.67|2.06|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||2.06|0.67|
73982071|NCT03745651|147509531|SUPERIORITY||Least Squares Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.53|-6.37|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.37|-14.53|<0.0001
73982072|NCT01383616|147509543|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||Comparison of 3 month ODI Score between Unipedicular and Bipedicular kyphoplasty groups||||0.85
73982073|NCT01383616|147509544|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
73982074|NCT01383616|147509545|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
73982075|NCT01383616|147509546|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
73982076|NCT01383616|147509547|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
73982077|NCT01383616|147509548|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
73982078|NCT01383616|147509549|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
73982079|NCT01383616|147509550|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
73873961|NCT02451514|147289691|OTHER||Geometric mean ratio|1.92|||||TWO_SIDED|95.0|1.33|2.78|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||2.78|1.33|
73873962|NCT02451514|147289691|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.61|1.17|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||1.17|0.61|
73982080|NCT01383616|147509551|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
73982081|NCT01383616|147509552|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
73982082|NCT01494467|147509555|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73982083|NCT01494467|147509556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.22|||<|0.001|TWO_SIDED|95.0|-10.18|-6.25|||ANCOVA|||||-6.25|-10.18|<0.001
73982084|NCT01494467|147509557|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73982085|NCT04739306|147509572|EQUIVALENCE|Predefined equivalence margin: -3 letters to +3 letters|Estimated difference in LS means|0.58|||||TWO_SIDED|90.0|-0.52|1.67|||ANCOVA|Analysis conducted for study eye. Primary endpoint as the dependent variable, treatment as a factor, baseline BCVA and country as covariates.||||1.67|-0.52|
73982086|NCT01077284|147509577|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.001
73982087|NCT01077284|147509577|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.003
73982088|NCT01077284|147509578|SUPERIORITY_OR_OTHER|||||||0.13||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.130
73982089|NCT01077284|147509578|SUPERIORITY_OR_OTHER|||||||0.348||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.348
73982090|NCT01077284|147509579|SUPERIORITY_OR_OTHER|||||||0.403||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.403
73982091|NCT01077284|147509579|SUPERIORITY_OR_OTHER|||||||0.413||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.413
73982092|NCT01077284|147509580|SUPERIORITY_OR_OTHER|||||||0.5535||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.||||||0.5535
73982093|NCT01077284|147509580|SUPERIORITY_OR_OTHER|||||||0.94||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.||||||0.9400
73982094|NCT02379078|147509590|SUPERIORITY|||||||0.0246|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.0246
73982095|NCT02379078|147509591|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73982096|NCT02379078|147509592|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
73982097|NCT02379078|147509593|SUPERIORITY|||||||0.468|||||||Mixed Models Analysis|||||||0.468
73982098|NCT02379078|147509594|SUPERIORITY|||||||0.6|||||||ANOVA|||||||0.60
74033694|NCT04263142|147620166|OTHER||Ratio|1.093|||||TWO_SIDED|90.0|0.9885|1.208|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablets/capsules.|||1.2080|0.9885|
74033695|NCT04263142|147620168|OTHER||Ratio|2.926|||||TWO_SIDED|90.0|2.3703|3.6107|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||3.6107|2.3703|
74033696|NCT04263142|147620168|OTHER||Ratio|2.594|||||TWO_SIDED|90.0|2.1003|3.2038|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.2038|2.1003|
73982099|NCT04908488|147509595|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Means Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||-0.01|||Mixed effects repeated measures model|Within subject correlation due to eye and the crossover design were accounted for in the model.|Lens difference (P1fA minus AMfA)|||-0.01||
73982100|NCT05265247|147509605|EQUIVALENCE|The two formulations were considered to be bioequivalent if the point estimate for the ratio lies completely within the range of 0.8-1.25.|Ratio of Geometric least squares mean|0.9531|||||TWO_SIDED|90.0|0.851|1.0673||||||||1.0673|0.8510|
73982101|NCT05265247|147509606|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% 2-sided confidence interval (CI) for the ratio lies completely within the range of 0.8-1.25.|Ratio of Geometric least squares mean|0.9538|||||TWO_SIDED|90.0|0.898|1.0132||||||||1.0132|0.8980|
73982102|NCT01721109|147509620|EQUIVALENCE|A sample size of 14 participants was estimated to provide over 95% power to show pharmacokinetic equivalence between adult and adolescent participants. EVG population PK from historical adult data was used for comparison. The inter-subject standard deviation (natural log scale) of EVG AUCtau observed in the population PK data was 0.31 (historical data).|Geometric least squares mean ratio|1.3029|||||TWO_SIDED|90.0|1.0479|1.62||||||||1.6200|1.0479|
73982103|NCT00134056|147509630|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.64|TWO_SIDED|95.0|0.9|1.19|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 18.0 months to 22.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.||1.19|0.90|0.64
73982104|NCT00134056|147509631|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.81|TWO_SIDED|95.0|0.89|1.16|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 6.0 months to 7.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.||1.16|0.89|0.81
73873963|NCT02451514|147289691|OTHER||Geometric mean ratio|1.62|||||TWO_SIDED|95.0|1.13|2.32|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||2.32|1.13|
73982105|NCT02312258|147509664|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.473|TWO_SIDED|95.0|0.861|1.381|||Log Rank||||"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), International Staging System (ISS) stage before initial therapy (stage I or II vs stage III), age (\<75 versus \[vs\] \>=75 years) at randomization, and best response to initial therapy (complete response (CR) or very good partial response (VGPR) vs partial response (PR)).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 versus\[vs\] \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.381|0.861|=0.473
73982106|NCT02312258|147509666|SUPERIORITY||Hazard Ratio (HR)|0.655|||<|0.001|TWO_SIDED|95.0|0.537|0.799|||Log Rank||||"P-value comparing TTP between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.799|0.537|<0.001
73982107|NCT02312258|147509667|SUPERIORITY||Hazard Ratio (HR)|0.984|||=|0.893|TWO_SIDED|95.0|0.777|1.246|||Log Rank||||"P-value comparing PFS2 between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.246|0.777|=0.893
73982108|NCT02312258|147509668|SUPERIORITY||Hazard Ratio (HR)|0.777|||=|0.018|TWO_SIDED|95.0|0.631|0.957|||Log Rank||||"P-value comparing TTNT between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.957|0.631|=0.018
73982109|NCT02312258|147509669|SUPERIORITY||Hazard Ratio (HR)|1.111|||=|0.462|TWO_SIDED|95.0|0.839|1.47|||Log Rank||||"P-value comparing Time to End of Next Line Therapy between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.470|0.839|=0.462
73955931|NCT04888585|147447666|SUPERIORITY||Response Rate Difference|26.6|||<|0.001|TWO_SIDED|95.0|16.5|36.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||36.7|16.5|<0.001
74033697|NCT04263142|147620169|OTHER||Ratio|3.146|||||TWO_SIDED|90.0|2.5925|3.8178|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||3.8178|2.5925|
73873964|NCT02451514|147289691|OTHER||Geometric mean ratio|7.15|||||TWO_SIDED|95.0|4.25|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||12|4.25|
73955932|NCT04888585|147447666|SUPERIORITY||Response Rate Difference|37.7|||<|0.001|TWO_SIDED|95.0|27.4|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||48.1|27.4|<0.001
73955933|NCT04888585|147447666|SUPERIORITY||Response Rate Difference|23.2|||<|0.001|TWO_SIDED|95.0|13.8|32.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||32.6|13.8|<0.001
73955934|NCT04888585|147447667|SUPERIORITY||Least Squares (LS) Mean Difference|-0.51||||0.007|TWO_SIDED|95.0|-0.87|-0.14|||Mixed Models Analysis|MMRM includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 40mg - Placebo|||-0.14|-0.87|0.007
73955935|NCT04888585|147447667|SUPERIORITY||Least Squares (LS) Mean Difference|-1.01|||<|0.001|TWO_SIDED|95.0|-1.38|-0.64|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-0.64|-1.38|<0.001
73955936|NCT04888585|147447667|SUPERIORITY||Least Squares (LS) Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.8|-1.05|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-1.05|-1.80|<0.001
73955937|NCT04888585|147447667|SUPERIORITY||Least Squares (LS) Mean Difference|-0.62|||<|0.001|TWO_SIDED|95.0|-0.99|-0.26|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340 E4W - Placebo|||-0.26|-0.99|<0.001
73955938|NCT04888585|147447668|SUPERIORITY||Least Squares (LS) Mean Difference|-4.56||||0.014|TWO_SIDED|95.0|-8.21|-0.92|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||-0.92|-8.21|0.014
73955939|NCT04888585|147447668|SUPERIORITY||Least Squares (LS) Mean Difference|-8.01|||<|0.001|TWO_SIDED|95.0|-11.7|-4.31|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-4.31|-11.70|<0.001
73955940|NCT04888585|147447668|SUPERIORITY||Least Squares (LS) Mean Difference|-11.41|||<|0.001|TWO_SIDED|95.0|-15.1|-7.73|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-7.73|-15.10|<0.001
73955941|NCT04888585|147447668|SUPERIORITY||Least Squares (LS) Mean Difference|-5.29||||0.004|TWO_SIDED|95.0|-8.89|-1.69|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||-1.69|-8.89|0.004
73955942|NCT04888585|147447669|SUPERIORITY||Response Rate Difference|24.7|||<|0.001|TWO_SIDED|95.0|12.1|37.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||37.3|12.1|<0.001
73955943|NCT04888585|147447669|SUPERIORITY||Response Rate Difference|30.2|||<|0.001|TWO_SIDED|95.0|17.4|42.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||42.9|17.4|<0.001
73955944|NCT04888585|147447669|SUPERIORITY||Response Rate Difference|45.4|||<|0.001|TWO_SIDED|95.0|33.5|57.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||57.4|33.5|<0.001
73955945|NCT04888585|147447669|SUPERIORITY||Response Rate Difference|24.6|||<|0.001|TWO_SIDED|95.0|11.9|37.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||37.3|11.9|<0.001
73955946|NCT04888585|147447670|SUPERIORITY||Response Rate Difference|6.5||||0.031|TWO_SIDED|95.0|0.6|12.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||12.4|0.6|0.031
73955947|NCT04888585|147447670|SUPERIORITY||Response Rate Difference|9.8||||0.007|TWO_SIDED|95.0|2.7|17.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||17.0|2.7|0.007
73955948|NCT04888585|147447670|SUPERIORITY||Response Rate Difference|10.9||||0.004|TWO_SIDED|95.0|3.6|18.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||18.2|3.6|0.004
73955949|NCT04888585|147447670|SUPERIORITY||Response Rate Difference|0.9||||0.709|TWO_SIDED|95.0|-4.0|5.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||5.9|-4.0|0.709
73955950|NCT04888585|147447671|SUPERIORITY||Response Rate Difference|16.9||||0.006|TWO_SIDED|95.0|4.9|28.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||28.9|4.9|0.006
74033698|NCT04263142|147620169|OTHER||Ratio|2.785|||||TWO_SIDED|90.0|2.2943|3.3807|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.3807|2.2943|
73873965|NCT02451514|147289691|OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|95.0|0.59|1.5|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||1.50|0.59|
73873966|NCT02451514|147289691|OTHER||Geometric mean ratio|6.73|||||TWO_SIDED|95.0|4.03|11.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||11|4.03|
73873967|NCT02451514|147289691|OTHER||Geometric mean ratio|0.61|||||TWO_SIDED|95.0|0.3|1.23|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||1.23|0.30|
73873968|NCT02451514|147289691|OTHER||Geometric mean ratio|5.53|||||TWO_SIDED|95.0|2.96|10.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||10|2.96|
73873969|NCT02451514|147289691|OTHER||Geometric mean ratio|3.38|||||TWO_SIDED|95.0|1.7|6.73|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||6.73|1.70|
73873970|NCT02451514|147289691|OTHER||Geometric mean ratio|2.58|||||TWO_SIDED|95.0|1.2|5.54|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||5.54|1.20|
73873971|NCT02451514|147289691|OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|95.0|0.66|2.56|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||2.56|0.66|
73873972|NCT02451514|147289691|OTHER||Geometric mean ratio|3.34|||||TWO_SIDED|95.0|1.57|7.11|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||7.11|1.57|
73873973|NCT02451514|147289691|OTHER||Geometric mean ratio|1.14|||||TWO_SIDED|95.0|0.51|2.59|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||2.59|0.51|
73873974|NCT02451514|147289691|OTHER||Geometric mean ratio|2.93|||||TWO_SIDED|95.0|1.4|6.12|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||6.12|1.40|
73955951|NCT04888585|147447671|SUPERIORITY||Response Rate Difference|25.8|||<|0.001|TWO_SIDED|95.0|13.5|38.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||38.1|13.5|<0.001
73955952|NCT04888585|147447671|SUPERIORITY||Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|18.9|44.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||44.2|18.9|<0.001
73955953|NCT04888585|147447671|SUPERIORITY||Response Rate Difference|23.2|||<|0.001|TWO_SIDED|95.0|11.0|35.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||35.4|11.0|<0.001
73955954|NCT04888585|147447672|SUPERIORITY||Response Rate Difference|14.1||||0.022|TWO_SIDED|95.0|2.0|26.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||26.2|2.0|0.022
73955955|NCT04888585|147447672|SUPERIORITY||Response Rate Difference|22.8|||<|0.001|TWO_SIDED|95.0|10.0|35.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||35.5|10.0|<0.001
74033699|NCT04263142|147620170|OTHER||Ratio|4.101|||||TWO_SIDED|90.0|3.2442|5.183|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||5.1830|3.2442|
73873975|NCT02451514|147289691|OTHER||Geometric mean ratio|3.35|||||TWO_SIDED|95.0|1.49|7.57|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||7.57|1.49|
73873976|NCT02451514|147289691|OTHER||Geometric mean ratio|0.52|||||TWO_SIDED|95.0|0.23|1.18|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||1.18|0.23|
73873977|NCT02451514|147289691|OTHER||Geometric mean ratio|5.94|||||TWO_SIDED|95.0|2.84|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||12|2.84|
73873978|NCT02451514|147289691|OTHER||Geometric mean ratio|3.09|||||TWO_SIDED|95.0|1.38|6.92|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||6.92|1.38|
73873979|NCT02451514|147289695|OTHER||Geometric mean ratio|8.5|||||TWO_SIDED|95.0|4.41|16.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||16|4.41|
73873980|NCT02451514|147289695|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|95.0|0.39|1.27|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.27|0.39|
73873981|NCT02451514|147289695|OTHER||Geometric mean ratio|5.97|||||TWO_SIDED|95.0|3.14|11.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||11|3.14|
73873982|NCT02451514|147289695|OTHER||Geometric mean ratio|197.0|||||TWO_SIDED|95.0|86.0|452.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||452|86|
73873983|NCT02451514|147289695|OTHER||Geometric mean ratio|0.98|||||TWO_SIDED|95.0|0.47|2.07|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||2.07|0.47|
73873984|NCT02451514|147289695|OTHER||Geometric mean ratio|193.0|||||TWO_SIDED|95.0|84.0|442.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||442|84|
73955956|NCT04888585|147447672|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|95.0|11.6|37.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||37.0|11.6|<0.001
73955957|NCT04888585|147447672|SUPERIORITY||Response Rate Difference|12.6||||0.042|TWO_SIDED|95.0|0.5|24.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||24.7|0.5|0.042
73955958|NCT04888585|147447673|SUPERIORITY||Response Rate Difference|5.1||||0.296|TWO_SIDED|95.0|-4.4|14.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||14.6|-4.4|0.296
73873985|NCT02451514|147289695|OTHER||Geometric mean ratio|3.51|||||TWO_SIDED|95.0|1.96|6.27|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||6.27|1.96|
73873986|NCT02451514|147289695|OTHER||Geometric mean ratio|0.62|||||TWO_SIDED|95.0|0.37|1.0|||Mixed Models Analysis|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.0|0.37|
73873987|NCT02451514|147289695|OTHER||Geometric mean ratio|2.17|||||TWO_SIDED|95.0|1.23|3.85|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||3.85|1.23|
73873988|NCT02451514|147289695|OTHER||Geometric mean ratio|3.57|||||TWO_SIDED|95.0|1.84|6.92|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||6.92|1.84|
73873989|NCT02451514|147289695|OTHER||Geometric mean ratio|0.72|||||TWO_SIDED|95.0|0.4|1.29|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||1.29|0.40|
73982110|NCT02312258|147509670|SUPERIORITY||Hazard Ratio (HR)|1.293|||||TWO_SIDED|95.0|0.968|1.727|||||||Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.|1.727|0.968|
73982111|NCT02312258|147509673|SUPERIORITY||Hazard Ratio (HR)|0.582|||=|0.001|TWO_SIDED|95.0|0.425|0.796|||Log Rank|||PFS for Participants with Known MRD+ at Study Entry|"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.796|0.425|=0.001
73873990|NCT02451514|147289695|OTHER||Geometric mean ratio|2.55|||||TWO_SIDED|95.0|1.33|4.89|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||4.89|1.33|
73873991|NCT02451514|147289695|OTHER||Geometric mean ratio|17.0|||||TWO_SIDED|95.0|8.18|35.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||35|8.18|
73873992|NCT02451514|147289695|OTHER||Geometric mean ratio|0.8|||||TWO_SIDED|95.0|0.41|1.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||1.53|0.41|
73873993|NCT02451514|147289695|OTHER||Geometric mean ratio|13.0|||||TWO_SIDED|95.0|6.59|28.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||28|6.59|
73873994|NCT02451514|147289695|OTHER||Geometric mean ratio|74.0|||||TWO_SIDED|95.0|34.0|160.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||160|34|
73873995|NCT02451514|147289695|OTHER||Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.38|1.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||1.53|0.38|
73873996|NCT02451514|147289695|OTHER||Geometric mean ratio|57.0|||||TWO_SIDED|95.0|27.0|121.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||121|27|
73873997|NCT02451514|147289695|OTHER||Geometric mean ratio|2.66|||||TWO_SIDED|95.0|1.46|4.83|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||4.83|1.46|
73873998|NCT02451514|147289695|OTHER||Geometric mean ratio|6.76|||||TWO_SIDED|95.0|3.96|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||12|3.96|
73873999|NCT02451514|147289695|OTHER||Geometric mean ratio|18.0|||||TWO_SIDED|95.0|10.0|32.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||32|10|
73874000|NCT02451514|147289695|OTHER||Geometric mean ratio|1.4|||||TWO_SIDED|95.0|0.72|2.71|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||2.71|0.72|
73874001|NCT02451514|147289695|OTHER||Geometric mean ratio|21.0|||||TWO_SIDED|95.0|12.0|37.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||37|12|
73874002|NCT02451514|147289695|OTHER||Geometric mean ratio|29.0|||||TWO_SIDED|95.0|15.0|55.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||55|15|
73874003|NCT02451514|147289695|OTHER||Geometric mean ratio|0.81|||||TWO_SIDED|95.0|0.47|1.38|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||1.38|0.47|
73874004|NCT02451514|147289695|OTHER||Geometric mean ratio|19.0|||||TWO_SIDED|95.0|12.0|31.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||31|12|
73874005|NCT02451514|147289695|OTHER||Geometric mean ratio|16.0|||||TWO_SIDED|95.0|9.27|26.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||26|9.27|
73874006|NCT02451514|147289695|OTHER||Geometric mean ratio|0.46|||||TWO_SIDED|95.0|0.17|1.28|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||1.28|0.17|
73874007|NCT02451514|147289695|OTHER||Geometric mean ratio|20.0|||||TWO_SIDED|95.0|8.2|48.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||48|8.20|
73874008|NCT02451514|147289695|OTHER||Geometric mean ratio|9.13|||||TWO_SIDED|95.0|3.78|22.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||22|3.78|
73874009|NCT02451514|147289708|OTHER||Geometric mean ratio|0.49|||||TWO_SIDED|95.0|0.28|0.87|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis Serogroup B, M14459||0.87|0.28|
74033700|NCT04263142|147620170|OTHER||Ratio|3.08|||||TWO_SIDED|90.0|2.4359|3.8935|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.8935|2.4359|
73874010|NCT02451514|147289708|OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.4|2.11|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis Serogroup B, M01-0240364||2.11|0.40|
73982112|NCT02312258|147509673|SUPERIORITY||Hazard Ratio (HR)|1.537|||=|0.398|TWO_SIDED|95.0|0.563|4.194|||Log Rank|||PFS for Participants with Known MRD- at Study Entry|"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|4.194|0.563|=0.398
73982113|NCT02312258|147509673|SUPERIORITY||Hazard Ratio (HR)|10.173|||=|0.012|TWO_SIDED|95.0|1.194|86.649|||Log Rank|||OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|86.649|1.194|=0.012
73982114|NCT02312258|147509675|SUPERIORITY||Hazard Ratio (HR)|1.011|||=|0.963|TWO_SIDED|95.0|0.631|1.621|||Log Rank||||"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.621|0.631|=0.963
73982115|NCT02312258|147509679|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.387|0.727|||Log Rank|||PFS Based on Frailty Status of Fit|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.727|0.387|<0.001
73982116|NCT02312258|147509679|SUPERIORITY||Hazard Ratio (HR)|0.746|||=|0.098|TWO_SIDED|95.0|0.526|1.058|||Log Rank|||PFS Based on Frailty Status of Unfit|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.058|0.526|=0.098
73982117|NCT02312258|147509679|SUPERIORITY||Hazard Ratio (HR)|0.733|||=|0.147|TWO_SIDED|95.0|0.481|1.117|||Log Rank|||PFS Based on Frailty Status of Frail|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.117|0.481|=0.147
73982118|NCT02312258|147509679|SUPERIORITY||Hazard Ratio (HR)|0.897|||=|0.714|TWO_SIDED|95.0|0.502|1.602|||Log Rank|||OS Based on Frailty Status of Fit|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.602|0.502|=0.714
74009188|NCT00397033|147569173|SUPERIORITY_OR_OTHER||LS Means Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.108||95.0|-2.3|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.2|-2.3|0.108
74009189|NCT00397033|147569173|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.43||95.0|-1.7|0.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.7|-1.7|0.430
73874011|NCT02451514|147289708|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|95.0|0.5|1.38|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, NZ98/254||1.38|0.50|
74033701|NCT00681538|147620320|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.84||||0.0002|TWO_SIDED|95.0|-1.29|-0.4|||ANCOVA|||||-0.40|-1.29|0.0002
73955959|NCT04888585|147447673|SUPERIORITY||Response Rate Difference|19.5|||<|0.001|TWO_SIDED|95.0|8.7|30.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||30.2|8.7|<0.001
73955960|NCT04888585|147447673|SUPERIORITY||Response Rate Difference|25.5|||<|0.001|TWO_SIDED|95.0|14.3|36.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||36.7|14.3|<0.001
73955961|NCT04888585|147447673|SUPERIORITY||Response Rate Difference|14.1||||0.007|TWO_SIDED|95.0|3.8|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||24.5|3.8|0.007
73955962|NCT04888585|147447674|SUPERIORITY||Response Rate Difference|7.1||||0.017|TWO_SIDED|95.0|1.3|13.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||13.0|1.3|0.017
73955963|NCT04888585|147447674|SUPERIORITY||Response Rate Difference|2.0||||0.424|TWO_SIDED|95.0|-2.8|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||6.8|-2.8|0.424
73955964|NCT04888585|147447674|SUPERIORITY||Response Rate Difference|2.6||||0.303|TWO_SIDED|95.0|-2.3|7.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||7.5|-2.3|0.303
73955965|NCT04888585|147447674|SUPERIORITY||Response Rate Difference|1.3||||0.551|TWO_SIDED|95.0|-2.9|5.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340 E4W - Placebo|||5.4|-2.9|0.551
73955966|NCT04888585|147447675|SUPERIORITY||Least Squares (LS) Mean Difference|-0.18||||0.022|TWO_SIDED|95.0|-0.33|-0.03|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|ABBV-154 40mg EOW - Placebo|||-0.03|-0.33|0.022
73955967|NCT04888585|147447675|SUPERIORITY||Least Squares (LS) Mean Difference|-0.25||||0.001|TWO_SIDED|95.0|-0.41|-0.1|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-0.10|-0.41|0.001
73955968|NCT04888585|147447675|SUPERIORITY||Least Squares (LS) Mean Difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.48|-0.17|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-0.17|-0.48|<0.001
73955969|NCT04888585|147447675|SUPERIORITY||Least Squares (LS) Mean Difference|-0.21||||0.007|TWO_SIDED|95.0|-0.36|-0.06|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||-0.06|-0.36|0.007
73955970|NCT04927975|147447676|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-7.6||||0.304|TWO_SIDED|95.0|-22.18|6.97|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||6.97|-22.18|0.304
73955971|NCT04927975|147447676|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-21.27||||0.005|TWO_SIDED|95.0|-36.02|-6.52|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||-6.52|-36.02|0.005
73955972|NCT04927975|147447676|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-19.6||||0.013|TWO_SIDED|95.0|-35.04|-4.16|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||-4.16|-35.04|0.013
74009190|NCT00397033|147569174|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.5||0.008||95.0|-6.7|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.0|-6.7|0.008
74009191|NCT00397033|147569174|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.4||0.175||95.0|-4.8|0.9|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.9|-4.8|0.175
73874012|NCT02451514|147289708|OTHER||Geometric mean ratio|0.79|||||TWO_SIDED|95.0|0.44|1.44|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, M10713||1.44|0.44|
73874013|NCT02451514|147289708|OTHER||Geometric mean ratio|0.6|||||TWO_SIDED|95.0|0.34|1.07|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, H44/76||1.07|0.34|
73874014|NCT02451514|147289708|OTHER||Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.52|1.12|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, 5/99||1.12|0.52|
73874015|NCT02451514|147289708|OTHER||Geometric mean ratio|2.99|||||TWO_SIDED|95.0|1.89|4.75|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup A||4.75|1.89|
73874016|NCT02451514|147289708|OTHER||Geometric mean ratio|4.69|||||TWO_SIDED|95.0|3.01|7.31|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup C||7.31|3.01|
73874017|NCT02451514|147289708|OTHER||Geometric mean ratio|8.6|||||TWO_SIDED|95.0|5.84|13.0|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup W||13|5.84|
73874018|NCT02451514|147289708|OTHER||Geometric mean ratio|7.03|||||TWO_SIDED|95.0|3.96|12.0|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup Y||12|3.96|
74009192|NCT00397033|147569175|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.9||0.001||95.0|-4.6|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.1|-4.6|0.001
73874019|NCT01773187|147289727|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||Pre-specified||||0.0003
73874020|NCT01773187|147289728|SUPERIORITY|||||||0.2368|||||||Fisher Exact|||Pre-specified||||0.2368
73874021|NCT02663622|147289766|SUPERIORITY||Cox Proportional Hazard|0.13||||0.0274|TWO_SIDED|95.0|0.01|0.62|||Log Rank|Log-rank test stratified by the matched sets||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean grade III-IV AGFS in days was 135.8 with an SD of 64.66.||0.62|0.01|0.0274
73955973|NCT04927975|147447677|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|6.9||||0.1|TWO_SIDED|95.0|-1.3|15.2|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||15.2|-1.3|0.100
73955974|NCT04927975|147447677|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|17.8||||0.002|TWO_SIDED|95.0|6.5|29.0|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||29.0|6.5|0.002
73955975|NCT04927975|147447677|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|11.7||||0.026|TWO_SIDED|95.0|1.4|21.9|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||21.9|1.4|0.026
73874022|NCT02663622|147289767|SUPERIORITY||Cox Proportional Hazard|0.57||||0.0988|TWO_SIDED|95.0|0.3|1.08|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean grade II-IV AGFS in days was 104.7 with an SD of 72.28.||1.08|0.30|0.0988
73874023|NCT02663622|147289773|SUPERIORITY||Cox Proportional Hazard|1.12||||0.9088|TWO_SIDED|95.0|0.43|2.88|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean OS in days was 319.3 with an SD of 93.83.||2.88|0.43|0.9088
73874024|NCT02663622|147289775|SUPERIORITY||Cox Proportional Hazard|1.27||||0.6131|TWO_SIDED|95.0|0.66|2.46|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean RFS in days was 296.0 with an SD of 115.32.||2.46|0.66|0.6131
73874025|NCT02848222|147289835|SUPERIORITY|||||||0.02||||||Threshold for significance was p \< 0.05|ANOVA|||||||0.02
73874026|NCT03652181|147289845|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 change in mean QSM||||||0.033|||||||t-test, 2 sided|||||||0.033
73874027|NCT03652181|147289846|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 change in mean DCEQP||||||0.3459|||||||t-test, 2 sided|||||||0.3459
73874028|NCT03652181|147289847|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 numbers||||||1|||||||Chi-squared|||||||1.0
73874029|NCT00086047|147289862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_DEVIATION|8.8||0.007|TWO_SIDED|95.0|1.57|9.22|||Mixed Models Analysis|||||9.22|1.57|0.007
73874030|NCT00853151|147289878|SUPERIORITY_OR_OTHER|||||||0.623||90.0||||p-value is for LY2428757 plus TT223 3 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.||||||0.623
73874031|NCT00853151|147289878|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||p-value is for LY2428757 plus TT223 2 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.||||||0.809
73874032|NCT00797277|147289932|NON_INFERIORITY_OR_EQUIVALENCE|There was no previous study comparing these 2 treatments. We hypothesized that the mean difference between the 2 treatments would be small.|Mean Difference (Final Values)|1.0|||<|0.05|||||||t-test, 2 sided|||we hypothesized that there would be no statistical significant difference between the 2 groups in the primary outcome.||||<0.05
73874033|NCT01751984|147289940|SUPERIORITY||Least squares mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.4|-22.1|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-22.1|-35.4|<0.0001
73874034|NCT01751984|147289941|SUPERIORITY||Least squares mean difference|-18.0|||<|0.0001|TWO_SIDED|95.0|-24.3|-11.8|||ANCOVA||Estimation from Week 2. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-11.8|-24.3|<0.0001
73874035|NCT01751984|147289941|SUPERIORITY||Least squares mean difference|-30.0|||<|0.0001|TWO_SIDED|95.0|-35.2|-24.7|||ANCOVA||Estimation from Week 4. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-24.7|-35.2|<0.0001
73982119|NCT02312258|147509679|SUPERIORITY||Hazard Ratio (HR)|1.75|||=|0.124|TWO_SIDED|95.0|0.85|3.601|||Log Rank|||OS Based on Frailty Status of Unfit|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|3.601|0.850|=0.124
73982120|NCT02312258|147509679|SUPERIORITY||Hazard Ratio (HR)|0.854|||=|0.63|TWO_SIDED|95.0|0.448|1.627|||Log Rank|||OS Based on Frailty Status of Frail|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.627|0.448|=0.630
73874036|NCT01751984|147289941|SUPERIORITY||Least squares mean difference|-28.8|||<|0.0001|TWO_SIDED|95.0|-36.9|-20.8|||ANCOVA||Estimation from Week 6. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-20.8|-36.9|<0.0001
73874037|NCT01751984|147289941|SUPERIORITY||Least squares mean difference|-28.5|||<|0.0001|TWO_SIDED|95.0|-37.2|-19.8|||ANCOVA||Estimation from Week 8. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-19.8|-37.2|<0.0001
73982121|NCT03293238|147509699|SUPERIORITY|||||||0.527|||||||ANOVA|||||||0.527
73982122|NCT03293238|147509700|SUPERIORITY|||||||0.749|||||||ANOVA|||||||0.749
73982123|NCT01313663|147509710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|90.0|0.32|2.65|||||HRs were estimated using the Pike estimator. The hazard ratio and p-value from the stratified log-rank test were adjusted for disease stage at Baseline only, due to sparse data.|||2.65|0.32|
73874038|NCT01751984|147289942|SUPERIORITY||Least squares mean difference|-5.8||||0.1892|TWO_SIDED|95.0|-14.5|2.9|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||2.9|-14.5|0.1892
73982124|NCT01857362|147509758|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|Ratio of geomectric means|1.0|||||TWO_SIDED|90.0|0.988|1.045|||ANOVA|||||1.045|0.988|
73982125|NCT01857362|147509759|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|ratio of geometric means|0.989|||||TWO_SIDED|90.0|0.945|1.034|||ANOVA|||||1.034|0.945|
73982126|NCT00409006|147509781|SUPERIORITY_OR_OTHER|||||||0.0618||95.0|||||Log Rank|||||||0.0618
73982127|NCT00409006|147509782|SUPERIORITY_OR_OTHER|||||||0.369||95.0|||||Regression, Logistic|Used the Wald Chi-squared statistic from a logistic regression analysis.||||||0.369
73874039|NCT01751984|147289943|SUPERIORITY||Least squares mean difference|-20.9|||<|0.0001|TWO_SIDED|95.0|-28.0|-13.9|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-13.9|-28.0|<0.0001
73874040|NCT01751984|147289944|SUPERIORITY||Least squares mean difference|-18.4|||<|0.0001|TWO_SIDED|95.0|-24.2|-12.7|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-12.7|-24.2|<0.0001
73874041|NCT01751984|147289945|SUPERIORITY||Least squares mean difference|18.7|||=|0.0962|TWO_SIDED|95.0|-3.5|40.8|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||40.8|-3.5|=0.0962
73874042|NCT01751984|147289946|SUPERIORITY||Least squares mean difference|-15.3|||=|0.0019|TWO_SIDED|95.0|-24.6|-6.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-6.0|-24.6|=0.0019
73874043|NCT01751984|147289947|SUPERIORITY||Least squares mean difference|-4.2|||=|0.2555|TWO_SIDED|95.0|-11.7|3.2|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||3.2|-11.7|=0.2555
73874044|NCT01751984|147289948|SUPERIORITY||Least squares mean difference|11.7||||0.2563|TWO_SIDED|95.0|-8.8|32.1|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||32.1|-8.8|0.2563
73982128|NCT00608959|147509786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91|STANDARD_DEVIATION|1.563|<|0.001||95.0|-2.55|-1.26|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.||-1.26|-2.55|<0.001
74009193|NCT00397033|147569175|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.9||0.209||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-2.8|0.209
74089633|NCT00754494|147732034|SUPERIORITY_OR_OTHER|||||||0.654|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.654
73955976|NCT04927975|147447678|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|6.6||||0.327|TWO_SIDED|95.0|-6.6|19.7|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||19.7|-6.6|0.327
73955977|NCT04927975|147447678|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|29.3|||<|0.001|TWO_SIDED|95.0|13.8|44.9|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||44.9|13.8|<0.001
73955978|NCT04927975|147447678|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|28.7|||<|0.001|TWO_SIDED|95.0|12.6|44.7|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||44.7|12.6|<0.001
73955979|NCT04927975|147447679|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|3.7||||0.34|TWO_SIDED|95.0|-3.9|11.2|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||11.2|-3.9|0.340
73955980|NCT04927975|147447679|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|3.8||||0.358|TWO_SIDED|95.0|-4.3|11.8|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||11.8|-4.3|0.358
73955981|NCT04927975|147447679|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|9.1||||0.027|TWO_SIDED|95.0|1.0|17.2|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||17.2|1.0|0.027
73955982|NCT04927975|147447680|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-7.45||||0.12|TWO_SIDED|95.0|-16.86|1.96|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||1.96|-16.86|0.120
73955983|NCT04927975|147447680|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-10.84||||0.026|TWO_SIDED|95.0|-20.37|-1.32|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||-1.32|-20.37|0.026
73955984|NCT04927975|147447680|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-14.27||||0.005|TWO_SIDED|95.0|-24.24|-4.3|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||-4.30|-24.24|0.005
73982129|NCT00608959|147509786|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.87|STANDARD_DEVIATION|1.656|<|0.001||95.0|-2.57|-1.17|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.||-1.17|-2.57|<0.001
73982130|NCT01248715|147509795|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||.460
73982131|NCT01248715|147509796|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
73982132|NCT01248715|147509797|SUPERIORITY|||||||0.732|||||||Wilcoxon (Mann-Whitney)|||||||.732
73982133|NCT01248715|147509798|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
73982134|NCT01248715|147509799|SUPERIORITY|||||||0.685|||||||Wilcoxon (Mann-Whitney)|||||||.685
73982135|NCT01248715|147509800|SUPERIORITY|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||||||.796
73982136|NCT01248715|147509801|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
73982137|NCT00674609|147509842|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.67||||0.014|TWO_SIDED|95.0|-1.21|-0.14|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.||-0.14|-1.21|0.014
73982138|NCT00674609|147509842|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.32||||0.244|TWO_SIDED|95.0|-0.86|0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.||0.22|-0.86|0.244
74033702|NCT00681538|147620321|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.731||||0.0003|TWO_SIDED|95.0|1.589|4.694|||Regression, Logistic||Odds ratio\>1 indicates an improvement in favour of Sativex|30% responders||4.694|1.589|0.0003
74033703|NCT00681538|147620321|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.647||||0.0612|TWO_SIDED|95.0|0.977|2.777|||Regression, Logistic||Odds ratio\>1 indicates an improvement in favour of Sativex|50% Responders||2.777|0.977|0.0612
73982139|NCT00674609|147509843|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.31||||0.346|TWO_SIDED|95.0|-0.97|0.34|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||0.34|-0.97|0.346
73982140|NCT00674609|147509843|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.02||||0.95|TWO_SIDED|95.0|-0.64|0.68|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||0.68|-0.64|0.95
73982141|NCT00674609|147509844|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.49||||0.11|TWO_SIDED|95.0|-0.11|1.09|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.09|-0.11|0.11
73982142|NCT00674609|147509844|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.46||||0.126|TWO_SIDED|95.0|-0.13|1.05|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.05|-0.13|0.126
73982143|NCT00674609|147509845|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.65||||0.045|TWO_SIDED|95.0|0.01|1.28|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.28|0.01|0.045
73982144|NCT00674609|147509845|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.62||||0.053|TWO_SIDED|95.0|-0.01|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.25|-0.01|0.053
73982145|NCT00674609|147509846|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|0.83||||0.016|TWO_SIDED|95.0|0.16|1.51|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.51|0.16|0.016
73982146|NCT00674609|147509846|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.66||||0.056|TWO_SIDED|95.0|-0.02|1.33|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.33|-0.02|0.056
74033704|NCT00681538|147620322|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-2.53||||0.0046|TWO_SIDED|95.0|-4.27|-0.79|||ANCOVA||A negative difference indicates an improvement in spasm frequency in favour of Sativex.|||-0.79|-4.27|0.0046
74033705|NCT00681538|147620323|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.51|||ANCOVA||A negative difference indicates an improvement in sleep disruption in favour of Sativex.|||-0.51|-1.25|<0.0001
74033706|NCT00681538|147620324|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-1.75||||0.0939|TWO_SIDED|95.0|-3.8|0.3|||ANCOVA||A negative difference indicates an improvement in spasticity in favour of Sativex.|||0.30|-3.80|0.0939
74033707|NCT00681538|147620325|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-2.85||||0.56|TWO_SIDED|95.0|-12.75|7.04|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For Arm||7.04|-12.75|0.56
73874045|NCT01751984|147289949|SUPERIORITY||Least squares mean difference|-23.7||||0.2565|TWO_SIDED|95.0|-65.4|18.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||18.0|-65.4|0.2565
73955985|NCT04927975|147447681|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-1.9||||0.545|TWO_SIDED|95.0|-8.3|4.4|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||4.4|-8.3|0.545
73982147|NCT00674609|147509847|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.68||||0.021|TWO_SIDED|95.0|0.1|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.25|0.10|0.021
73955986|NCT04927975|147447681|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|1.9||||0.565|TWO_SIDED|95.0|-4.5|8.3|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||8.3|-4.5|0.565
73955987|NCT04927975|147447681|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-1.1||||0.754|TWO_SIDED|95.0|-7.8|5.6|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||5.6|-7.8|0.754
73955988|NCT03568162|147447683|SUPERIORITY|The analysis was conducted using a mixed model for repeated measures (MMRM) model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit|LS Mean Difference|-20.192|STANDARD_ERROR_OF_MEAN|7.4781|=|0.008|TWO_SIDED|95.0|-34.944|5.439|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference|||5.439|-34.944|= 0.008
73955989|NCT03568162|147447683|SUPERIORITY|The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.|LS Mean Difference|-14.439|STANDARD_ERROR_OF_MEAN|7.6622|=|0.061|TWO_SIDED|95.0|-29.552|0.674|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference|||0.674|-29.552|= 0.061
73955990|NCT03568162|147447683|SUPERIORITY|The analysis was conducted using a mixed MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.|LS Mean Difference|3.144|STANDARD_ERROR_OF_MEAN|7.8864|=|0.691|TWO_SIDED|95.0|-12.41|18.698|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference.|||18.698|-12.410|= 0.691
73955991|NCT03568162|147447683|SUPERIORITY||LS Mean Difference|-17.199|STANDARD_ERROR_OF_MEAN|6.409|=|0.008|TWO_SIDED|95.0|-29.895|-4.503|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference.|The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.||-4.503|-29.895|= 0.008
73982148|NCT00674609|147509847|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|0.64||||0.028|TWO_SIDED|95.0|0.07|1.22|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.22|0.07|0.028
73982149|NCT00674609|147509848|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|2.47||||0.443|TWO_SIDED|95.0|-3.87|8.81|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.||8.81|-3.87|0.443
73982150|NCT00674609|147509848|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|0.84||||0.793|TWO_SIDED|95.0|-5.46|7.13|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.||7.13|-5.46|0.793
73982151|NCT00674609|147509849|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.04||||0.619|TWO_SIDED|95.0|-5.23|3.15|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.||3.15|-5.23|0.619
74009194|NCT00397033|147569177|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.6||0.032||95.0|-6.5|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.3|-6.5|0.032
74033708|NCT00681538|147620325|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.04||||0.98|TWO_SIDED|95.0|-2.56|2.64|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For leg||2.64|-2.56|0.98
74033709|NCT00681538|147620326|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-3.34||||0.0687|TWO_SIDED|95.0|-6.95|0.26|||ANCOVA||A negative treatment difference indicates an improvement in favour of Sativex.|||0.26|-6.95|0.0687
74033710|NCT00681538|147620327|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.703||||0.0234|TWO_SIDED|95.0|1.075|2.698|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||2.698|1.075|0.0234
74033711|NCT00681538|147620328|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.4||||0.0053|TWO_SIDED|95.0|1.297|4.443|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||4.443|1.297|0.0053
74033712|NCT00681538|147620329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.792||||0.0613|TWO_SIDED|95.0|0.973|3.301|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||3.301|0.973|0.0613
74033713|NCT00681538|147620330|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.958||||0.0045|TWO_SIDED|95.0|1.232|3.112|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||3.112|1.232|0.0045
74033714|NCT00681538|147620331|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.02||||0.2836|TWO_SIDED|95.0|-0.02|0.07|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|For Health State Index||0.07|-0.02|0.2836
74033715|NCT00681538|147620331|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.24||||0.5644|TWO_SIDED|95.0|-3.01|5.5|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|Health Status VAS||5.50|-3.01|0.5644
73874046|NCT01751984|147289950|SUPERIORITY||Least squares mean difference|4.0||||0.776|TWO_SIDED|95.0|-24.1|32.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||32.0|-24.1|0.7760
73874047|NCT01751984|147289951|SUPERIORITY||Clopper-Pearson methodology|61.8|||<|0.0001|TWO_SIDED|95.0|45.4|78.1||Based on Fisher's exact test comparing the proportion of participants who achieved LDL-C goal at Week 8 (End of Study) in the ETC-1002 and placebo groups.|Fisher Exact||ETC-1002 minus placebo for the proportion of participants who achieved LDL-C goal at Week 8 (End of Study). The confidence interval was based on a normal approximation to the binomial distribution.|||78.1|45.4|<0.0001
73955992|NCT02081391|147447710|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0404|TWO_SIDED|95.0|-0.09|0.0|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used SOAM as factors. For participants discontinuing treatment before 12 hours for any other reason than no further need of opioid analgesics or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant's discontinuation.||0|-0.09|0.0404
73955993|NCT02081391|147447711|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0154|TWO_SIDED|95.0|-0.18|-0.02|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used supplemental opioid analgesic medication (SOAM) as factors. For participants discontinuing treatment before 24 hours for any other reason than no further need of SOAM or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant's discontinuation.||-0.02|-0.18|0.0154
73955994|NCT02926937|147447738|SUPERIORITY||Difference in Least Squares (LS) Mean|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.975|-0.415|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.415|-0.975|<0.0001
73955995|NCT02926937|147447739|SUPERIORITY||Difference in LS Mean|-0.565||||0.0141|TWO_SIDED|95.0|-1.0166|-0.114|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.||-0.1140|-1.0166|0.0141
73955996|NCT02926937|147447740|SUPERIORITY||Difference in LS Mean|-0.346||||0.2081|TWO_SIDED|95.0|-0.8853|0.1928|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups under Amendment 1 randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.||0.1928|-0.8853|0.2081
74033716|NCT00681538|147620332|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.06||||0.9369|TWO_SIDED|95.0|-1.62|1.49|||ANCOVA||A negative difference indicates an improvement in depression in favour of Sativex.|||1.49|-1.62|0.9369
74033717|NCT00630812|147620333|SUPERIORITY||Mean Difference (Net)|54.14||||0.059|TWO_SIDED|95.0|-1.97|110.26|||Mixed Models Analysis|||||110.26|-1.97|0.059
74033718|NCT00630812|147620333|SUPERIORITY||Odds Ratio (OR)|1.69||||0.041|TWO_SIDED|95.0|1.02|2.8||Response defined as change of \>=100mL at week 26|Regression, Logistic|45.7% response on Mannitol 400mg, 35.5% on Control||||2.80|1.02|0.041
74033719|NCT00630812|147620334|SUPERIORITY||Mean Difference (Net)|43.49||||0.177|TWO_SIDED|95.0|-19.8|106.78|||Mixed Models Analysis|||||106.78|-19.8|0.177
74033720|NCT00630812|147620335|SUPERIORITY||Rate ratio|0.85||||0.52|TWO_SIDED|95.0|0.51|1.41|||Poisson regression|Offset of the natural logarithm of follow-up time||||1.41|0.51|0.520
74033721|NCT00630812|147620336|SUPERIORITY||Rate ratio|0.75||||0.328|TWO_SIDED|95.0|0.42|1.33|||Poisson regression|Offset of the natural logarithm of follow-up time||||1.33|0.42|0.328
74033722|NCT00630812|147620337|SUPERIORITY||Rate ratio|0.89||||0.368|TWO_SIDED|95.0|0.69|1.15|||Poisson regression|||||1.15|0.69|0.368
74033723|NCT00630812|147620338|SUPERIORITY||Mean Difference (Net)|2.42||||0.024|TWO_SIDED|95.0|0.33|4.51|||ANCOVA|||||4.51|0.33|0.024
74033724|NCT00630812|147620339|SUPERIORITY||Mean Difference (Net)|71.35||||0.022|TWO_SIDED|95.0|10.57|132.13|||Mixed Models Analysis|||||132.13|10.57|0.022
74033725|NCT00630812|147620340|SUPERIORITY||Mean Difference (Net)|34.34||||0.49|TWO_SIDED|95.0|-63.47|132.14|||Mixed Models Analysis|||||132.14|-63.47|0.49
74033726|NCT00630812|147620341|SUPERIORITY|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||||||0.042
73874048|NCT03187132|147289958|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|1.17||0.111|TWO_SIDED|95.0|-4.15|0.43|||Mixed Models Analysis||The estimate is for the Digital Pain Reduction Kit arm.|We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.||.43|-4.15|.111
73874049|NCT03187132|147289959|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|1.27||0.612|TWO_SIDED|95.0|-1.84|3.12|||Mixed Models Analysis||The estimate is for the Digital Pain Reduction Kit arm.|We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.||3.12|-1.84|.612
73874050|NCT03187132|147289960|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.58||0.87|TWO_SIDED|95.0|-5.51|4.66|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||4.66|-5.51|.87
73874051|NCT03187132|147289960|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.274||0.787|TWO_SIDED|95.0|-0.54|0.54|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.54|-.54|.787
73874052|NCT03187132|147289960|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.569|TWO_SIDED|95.0|-0.88|0.48|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.48|-.88|.569
73874053|NCT03187132|147289961|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.467|TWO_SIDED|95.0|-0.23|0.49|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.49|-.23|.467
73874054|NCT03187132|147289962|SUPERIORITY||Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.986||0.852|TWO_SIDED|95.0|0.07|9.07|||Regression, Logistic|||We used a multilevel logistic regression with random effects at the individual level and fixed effects for week and study-arm.||9.07|.07|.852
73874055|NCT03594773|147289982|SUPERIORITY||Mean Difference (Final Values)|-0.496|STANDARD_ERROR_OF_MEAN|1.56||0.752|TWO_SIDED|95.0|-3.62|2.63|||t-test, 2 sided|df=56, equal variances assumed||||2.63|-3.62|.752
73874056|NCT03594773|147289983|SUPERIORITY||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|2.62||0.633|TWO_SIDED|95.0|-4.01|6.52|||t-test, 2 sided|df=49, equal variances assumed||||6.52|-4.01|.633
73874057|NCT03594773|147289984|SUPERIORITY||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|1.73||0.586|TWO_SIDED|95.0|-2.53|4.44|||t-test, 2 sided|df=49, equal variances assumed||||4.44|-2.53|.586
73874058|NCT00123123|147290013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675||95.0|||||ANOVA|||A mixed effect model was used to compare overall treatment effects between groups for repeated measures data. The group comparison for each time point was performed using ANOVA.||||0.6750
73874059|NCT03573323|147290020|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73874060|NCT03573323|147290021|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73955997|NCT02926937|147447741|SUPERIORITY||Difference in LS Mean|-1.556|||<|0.0001|TWO_SIDED|95.0|-2.1876|-0.9234|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥ 130mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.9234|-2.1876|<0.0001
73955998|NCT02926937|147447742|SUPERIORITY||Difference in LS Mean|-3.5||||0.168|TWO_SIDED|95.0|-8.478|1.476|||ANCOVA|||The change from baseline to Week 12 is analyzed using analysis ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening and country as fixed effects, and baseline SBP as a covariate.||1.476|-8.478|0.1680
73955999|NCT02926937|147447743|SUPERIORITY||Difference in LS Mean|-0.78||||0.5467|TWO_SIDED|95.0|-3.311|1.753|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||1.753|-3.311|0.5467
73956000|NCT02926937|147447744|SUPERIORITY||Difference in LS Mean|-3.19||||0.0193|TWO_SIDED|95.0|-5.869|-0.518|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-0.518|-5.869|0.0193
73956001|NCT02926937|147447745|SUPERIORITY||Difference in LS Mean|-1.54||||0.0005|TWO_SIDED|95.0|-2.404|-0.676|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.676|-2.404|0.0005
73956002|NCT02926937|147447746|SUPERIORITY||Difference in LS Mean|-1.17||||0.0406|TWO_SIDED|95.0|-2.281|-0.05|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.050|-2.281|0.0406
73956003|NCT02926937|147447747|SUPERIORITY||Percentage Difference|12.6||||0.0037|TWO_SIDED|95.0|4.18|21.02|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (\<=8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, \>=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.||21.02|4.18|0.0037
73956004|NCT02926937|147447748|SUPERIORITY||Percentage Difference|19.2||||0.0007|TWO_SIDED|95.0|8.39|30.0|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (\<=8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, \>=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.||30.00|8.39|0.0007
73874061|NCT03573323|147290022|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73874062|NCT03573323|147290023|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73874063|NCT03573323|147290024|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73982152|NCT00674609|147509849|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-4.07||||0.048|TWO_SIDED|95.0|-8.1|-0.05|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.||-0.05|-8.10|0.048
73982153|NCT00674609|147509850|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.04||||0.688|TWO_SIDED|95.0|-0.25|0.16|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.||0.16|-0.25|0.688
73982154|NCT00674609|147509850|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.01||||0.899|TWO_SIDED|95.0|-0.19|0.22|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.||0.22|-0.19|0.899
73982155|NCT03884478|147509855|OTHER||Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|0.82||0.0001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.0001
73982156|NCT03884478|147509855|OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|0.77||0.005|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Control Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.005
73982157|NCT03884478|147509855|OTHER||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.82||0.25|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol Only Arm.||||.25
73982158|NCT03884478|147509856|OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.84||0.025|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.025
74009195|NCT00397033|147569177|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.5||0.013||95.0|-6.8|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.8|-6.8|0.013
73874064|NCT03573323|147290025|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73874065|NCT03573323|147290026|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73874066|NCT03573323|147290027|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73874067|NCT03573323|147290028|SUPERIORITY|||||||0.414|||||||Cochran-Mantel-Haenszel|||||||0.414
73874068|NCT04308941|147290032|OTHER|The mean and standard deviation was analyzed.||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
73874069|NCT02868554|147290038|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.07|TWO_SIDED||||||ANOVA|||||||0.07
73874070|NCT02868554|147290039|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
73874071|NCT02714569|147290043|NON_INFERIORITY|Analyses were based on a pre-defined non-inferiority margin|Least Square Means Percentage|204.8|||||TWO_SIDED|90.0|161.9|259.0|||||Analysis was the estimate of the ratio fasted versus fed.|Geometric Mean Fed/Fasted Ratio of LY3202328 Cmax at 30 mg||259.0|161.9|
73874072|NCT02714569|147290045|NON_INFERIORITY|Analyses were based on a pre-defined non-inferiority margin|Least Squares Mean Percentage|193.3|||||TWO_SIDED|90.0|144.7|258.2||||||Geometric Mean Fed/Fasted Ratio of LY3202328 AUC(0-inf) at 30 mg||258.2|144.7|
73874073|NCT02714569|147290057|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|141.0|||||TWO_SIDED|90.0|67.9|293.0||||||Part B Placebo||293.0|67.9|
73874074|NCT02714569|147290057|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|70.8|||||TWO_SIDED|90.0|31.9|157.1||||||Part B 5 mg LY||157.1|31.9|
73874075|NCT02714569|147290057|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|109.2|||||TWO_SIDED|90.0|99.8|119.5||||||Part B 20 mg LY||119.5|99.8|
74009196|NCT00397033|147569178|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.232||95.0|-2.0|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-2.0|0.232
73982159|NCT03884478|147509856|OTHER||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|0.79||0.11|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.11
73982160|NCT03884478|147509856|OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.84||0.66|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.66
73982161|NCT03884478|147509857|OTHER||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
73982162|NCT03884478|147509857|OTHER||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||<.001
73982163|NCT03884478|147509857|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.25||0.88|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.88
73982164|NCT03884478|147509858|OTHER||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.26||0.03|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.03
73982165|NCT03884478|147509858|OTHER||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.24||0.059|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.059
73982166|NCT03884478|147509858|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.71|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.71
73982167|NCT03884478|147509859|OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
73982168|NCT03884478|147509859|OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||<.001
73982169|NCT03884478|147509859|OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.19||0.87|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.87
74009197|NCT00397033|147569178|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.31||95.0|-1.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-1.8|0.310
74009198|NCT00397033|147569179|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.004||95.0|-3.1|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.6|-3.1|0.004
73982170|NCT03884478|147509860|OTHER||Median Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
73982171|NCT03884478|147509860|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.002
73982172|NCT03884478|147509860|OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.2||0.43|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.43
73982173|NCT04454125|147509915|SUPERIORITY||Odds Ratio (OR)|0.61||||0.32|TWO_SIDED|95.0|0.23|1.61|||Generalized linear model, repeat measure|Generalized linear model (GLM) fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group arm, visit, interaction term (arm\*visit) and adjusting for visit 2 severe asthma exacerbation.|Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||1.61|0.23|0.32
73982174|NCT04454125|147509915|SUPERIORITY||Odds Ratio (OR)|0.31||||0.29|TWO_SIDED|95.0|0.03|2.76|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 severe asthma exacerbation.|Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||2.76|0.03|0.29
73982175|NCT04454125|147509915|SUPERIORITY||Odds Ratio (OR)|0.51||||0.58|TWO_SIDED|95.0|0.05|5.68|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link||Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 severe asthma exacerbation.|5.68|0.05|0.58
73982176|NCT04454125|147509915|SUPERIORITY||Odds Ratio (OR)|0.5||||0.02|TWO_SIDED|95.0|0.27|0.91|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||0.91|0.27|0.02
73982177|NCT04454125|147509915|SUPERIORITY||Odds Ratio (OR)|0.23||||0.03|TWO_SIDED|95.0|0.06|0.86|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||0.86|0.06|0.03
73982178|NCT04454125|147509915|SUPERIORITY||Odds Ratio (OR)|0.47||||0.3|TWO_SIDED|95.0|0.11|1.95|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||1.95|0.11|0.30
73982179|NCT04454125|147509916|SUPERIORITY||Mean Difference (Net)|0.17||||0.8|TWO_SIDED|95.0|-1.17|1.51|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||1.51|-1.17|0.80
73982180|NCT04454125|147509916|SUPERIORITY||Mean Difference (Net)|2.02||||0.001|TWO_SIDED|95.0|0.88|3.15|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||3.15|0.88|0.001
73982181|NCT04454125|147509916|SUPERIORITY||Mean Difference (Net)|1.85||||0.04|TWO_SIDED|95.0|0.09|3.61|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||3.61|0.09|0.04
73982182|NCT04454125|147509916|SUPERIORITY||Mean Difference (Net)|-0.31||||0.7|TWO_SIDED|95.0|-1.87|1.25|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Score. Obtained at all visits.||1.25|-1.87|0.70
73982183|NCT04454125|147509916|SUPERIORITY||Mean Difference (Net)|3.96||||0.14|TWO_SIDED|95.0|-1.27|9.2|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Score. Obtained at all visits.||9.20|-1.27|0.14
73982184|NCT04454125|147509916|SUPERIORITY||Mean Difference (Net)|4.27||||0.13|TWO_SIDED|95.0|-1.19|9.73|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Scores.||9.73|-1.19|0.13
73982185|NCT04454125|147509917|SUPERIORITY||Mean Difference (Net)|0.25||||0.11|TWO_SIDED|95.0|-0.06|0.55|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.55|-0.06|0.11
73982186|NCT04454125|147509917|SUPERIORITY||Mean Difference (Net)|0.54||||0.002|TWO_SIDED|95.0|0.2|0.88|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.88|0.20|0.002
73982187|NCT04454125|147509917|SUPERIORITY||Mean Difference (Net)|0.3||||0.2|TWO_SIDED|95.0|-0.16|0.75|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.75|-0.16|0.20
73982188|NCT04454125|147509918|SUPERIORITY||Odds Ratio (OR)|0.94||||0.87|TWO_SIDED|95.0|0.45|1.96|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||1.96|0.45|0.87
73982189|NCT04454125|147509918|SUPERIORITY||Odds Ratio (OR)|6.89||||0.004|TWO_SIDED|95.0|1.85|25.6|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||25.6|1.85|0.004
73982190|NCT04454125|147509918|SUPERIORITY||Odds Ratio (OR)|7.31||||0.01|TWO_SIDED|95.0|1.62|32.9|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||32.9|1.62|0.01
73982191|NCT04454125|147509919|SUPERIORITY||Odds Ratio (OR)|0.34||||0.15|TWO_SIDED|95.0|0.08|1.47|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||1.47|0.08|0.15
73982192|NCT04454125|147509919|SUPERIORITY||Odds Ratio (OR)|0.96||||0.94|TWO_SIDED|95.0|0.35|2.68|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||2.68|0.35|0.94
73982193|NCT04454125|147509919|SUPERIORITY||Odds Ratio (OR)|2.79||||0.26|TWO_SIDED|95.0|0.47|16.5|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||16.5|0.47|0.26
74033727|NCT03656926|147620345|SUPERIORITY|Estimates are from a Linear Mixed Model on the response variable change from baseline in FEV1 with factors for time splines, treatment, the interactions of time splines by treatment, baseline FEV1, the interactions of time splines with baseline FEV1, region (North America vs all other countries together), age (\<55 versus \>=55 years), use of azithromycin at randomization, and time as random effect.|least square mean difference|-0.028||||0.6639|TWO_SIDED|95.0|-0.16|0.104||This is a 1-side p value.|Mixed Models Analysis|||V9 - week 48||0.104|-0.160|0.6639
74033728|NCT00506077|147620354|SUPERIORITY_OR_OTHER|||||||0.939||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained longitudinal data analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.939
73982194|NCT04454125|147509920|SUPERIORITY||Odds Ratio (OR)|0.42||||0.004|TWO_SIDED|95.0|0.24|0.76|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits||0.76|0.24|0.004
73982195|NCT04454125|147509920|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.05|0.31|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits.||0.31|0.05|<0.0001
73982196|NCT04454125|147509920|SUPERIORITY||Odds Ratio (OR)|0.29||||0.03|TWO_SIDED|95.0|0.1|0.87|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits.||0.87|0.10|0.03
73982197|NCT02301299|147509921|OTHER|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the early hospital arrival would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG.||The effect size was defined as the sum of expected slope change in monthly early hospital arrival rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05.|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly early arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.|||<.0001
73982198|NCT02301299|147509922|OTHER|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the EMS use would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|||The effect size was defined as the sum of expected slope change in monthly EMS use rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05. The effect size is measured in slope of change over time (negative values indicate a decrease while positive values indicate an increase in % EMS use/month).|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly EMS arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.|||<.0001
73982199|NCT03512041|147509924|SUPERIORITY|||||||0.172|||||||ANOVA|||||||0.172
73982200|NCT03512041|147509925|SUPERIORITY|||||||0.169|||||||ANOVA|||||||0.169
73982201|NCT03512041|147509926|SUPERIORITY|||||||0.501|||||||ANOVA|||||||0.501
73982202|NCT00828139|147509958|SUPERIORITY_OR_OTHER||3-month PFS|0.24|||||TWO_SIDED|90.0|0.14|0.37|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier. The 3-month PFS estimated value corresponds to the probability of PFS at month 3.||0.37|0.14|
73982203|NCT00828139|147509958|SUPERIORITY_OR_OTHER||3-month PFS|0.15|||||TWO_SIDED|90.0|0.07|0.27|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.27|0.07|
73982204|NCT00828139|147509958|SUPERIORITY_OR_OTHER||3-month PFS|0.27|||||TWO_SIDED|90.0|0.18|0.39|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.39|0.18|
73982205|NCT00828139|147509958|SUPERIORITY_OR_OTHER||3-month PFS|0.1|||||TWO_SIDED|90.0|0.04|0.2|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.2|0.04|
73982206|NCT00828139|147509958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|90.0|0.91|1.92||||||Hazard Ratio was evaluated using a logrank test.||1.92|0.91|
73874076|NCT02714569|147290057|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|107.7|||||TWO_SIDED|90.0|68.1|170.4||||||Part B 100 mg LY||170.4|68.1|
73874077|NCT02714569|147290057|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|213.3|||||TWO_SIDED|90.0|200.3|227.1||||||Part B 300 mg LY||227.1|200.3|
73982207|NCT00828139|147509958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||||TWO_SIDED|90.0|1.08|2.1||||||Hazard Ratio was evaluated using log-rank test.||2.10|1.08|
73982208|NCT01922102|147509988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.2|||<|0.001|TWO_SIDED|95.0|3.3|7.1||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure: H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively.||7.1|3.3|<0.001
73982209|NCT01922102|147509988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|3.5|7.6||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|"The following 2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure:~H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively."||7.6|3.5|<0.001
73982210|NCT01922102|147509989|NON_INFERIORITY_OR_EQUIVALENCE|"one-sided hypotheses were tested under the Type I error rate of 0.025, if H01 and H02 were rejected: H03: μRanibizumab-II - μRanibizumab-I ≤ -5 vs. HA3: μRanibizumab-II - μRanibizumab-I \> -5.~Otherwise, H03 was not to be considered as rejected."|Mean Difference (Net)|0.4|||<|0.001|TWO_SIDED|95.0|-1.3|2.1||Non-inferiority could be claimed if the corresponding one-sided p-value was ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|||2.1|-1.3|<0.001
73982211|NCT01345253|147510014|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.99||||0.0001|TWO_SIDED|95.0|1.4|2.82|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement (C) levels (low C3 and/or C4 vs. no low C3 or C4).|||2.82|1.40|0.0001
73982212|NCT01345253|147510015|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.0001|TWO_SIDED|95.0|1.41|2.83|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|||2.83|1.41|0.0001
73982213|NCT01345253|147510016|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.76||||0.0116|TWO_SIDED|95.0|1.13|2.74|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|||2.74|1.13|0.0116
73982214|NCT01345253|147510017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0288|||||||Rank ANCOVA|||||||0.0288
73982215|NCT01345253|147510018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5||||0.0004|TWO_SIDED|95.0|0.34|0.73|||Regression, Cox|||||0.73|0.34|0.0004
73982216|NCT04694300|147510020|SUPERIORITY|Lower the maximum pain intensity score the more effective the analgesic|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73982217|NCT04694300|147510021|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73982218|NCT04694300|147510022|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
73982219|NCT04694300|147510023|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73982220|NCT04694300|147510026|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
73982221|NCT04694300|147510027|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74033729|NCT00506077|147620355|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-Value Comments (limit 250 characters): The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
73982222|NCT04694300|147510028|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|Higher percentage inhibition relates to greater selectivity for COX-2||||||0.59
73982223|NCT04694300|147510029|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
73982224|NCT01877720|147510043|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
73982225|NCT01877720|147510044|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Paired t-test|||||||0.001
73982226|NCT01877720|147510045|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Paired t-test|||||||0.74
73982227|NCT01877720|147510046|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Paired t-test|||||||0.003
73982228|NCT01877720|147510047|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Paired t-test|||||||0.002
73982229|NCT01877720|147510048|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Paired t-test|||||||0.003
73982230|NCT01877720|147510049|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Paired t-test|||||||0.012
73982231|NCT01877720|147510050|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Paired t-test|||||||0.67
73982232|NCT01877720|147510051|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<0.001
73982233|NCT01877720|147510052|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<0.001
73982234|NCT02068352|147510064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|11.93||||0.069|TWO_SIDED|95.0|-0.08|23.95||P-value was derived using Cochran-Mantel-Haenszel (CMH) test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||23.95|-0.08|0.0690
73982235|NCT02068352|147510064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|18.23||||0.0165|TWO_SIDED|95.0|4.99|31.46||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||31.46|4.99|0.0165
73982236|NCT02068352|147510064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|12.3||||0.0617|TWO_SIDED|95.0|0.06|24.53||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||24.53|0.06|0.0617
73982237|NCT02068352|147510065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47||||0.0128|TWO_SIDED|95.0|-0.84|-0.1|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, and interaction of treatment by visit as terms, Baseline score as a covariate.||||-0.10|-0.84|0.0128
73982238|NCT02068352|147510065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46||||0.0134|TWO_SIDED|95.0|-0.81|-0.1|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||-0.10|-0.81|0.0134
73982239|NCT02068352|147510066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0048|TWO_SIDED|95.0|-0.85|-0.16|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.16|-0.85|0.0048
73982240|NCT02068352|147510066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0045|TWO_SIDED|95.0|-0.84|-0.16|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.16|-0.84|0.0045
73982241|NCT02068352|147510068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.26||||0.4173|TWO_SIDED|95.0|-8.99|21.52||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||21.52|-8.99|0.4173
73982242|NCT02068352|147510068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.47||||0.4895|TWO_SIDED|95.0|-9.43|20.36||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||20.36|-9.43|0.4895
73982243|NCT02068352|147510068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.19||||0.2677|TWO_SIDED|95.0|-6.74|25.12||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||25.12|-6.74|0.2677
73982244|NCT02068352|147510068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.12||||0.2319|TWO_SIDED|95.0|-5.63|25.87||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||25.87|-5.63|0.2319
73982245|NCT02068352|147510069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11||||0.3213|TWO_SIDED|95.0|-3.33|1.11|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||1.11|-3.33|0.3213
73874078|NCT02714569|147290057|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|115.4|||||TWO_SIDED|90.0|91.2|146.2||||||Part B Overall||146.2|91.2|
73874079|NCT02714569|147290058|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|155.0|||||TWO_SIDED|90.0|87.6|274.2||||||Part B Placebo||274.2|87.6|
73874080|NCT02714569|147290058|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|71.5|||||TWO_SIDED|90.0|40.7|125.3||||||Part B 5 mg LY||125.3|40.7|
73874081|NCT02714569|147290058|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratios (%)|122.4|||||TWO_SIDED|90.0|90.7|165.1||||||Part B 20 mg LY||165.1|90.7|
73874082|NCT02714569|147290058|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|136.6|||||TWO_SIDED|90.0|89.8|207.7||||||Part B 100 mg LY||207.7|89.8|
73956005|NCT02926937|147447749|SUPERIORITY||Difference in LS Mean|-0.67|||<|0.0001|TWO_SIDED|95.0|-0.989|-0.354|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.354|-0.989|<0.0001
73956006|NCT03722446|147447756|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73956007|NCT03722446|147447757|SUPERIORITY|||||||0.0102|||||||t-test, 1 sided|||||||0.01020
73956008|NCT03722446|147447758|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
73956009|NCT03722446|147447759|SUPERIORITY|||||||0.3753|||||||Chi-squared|||||||0.3753
73956010|NCT03722446|147447760|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
73956011|NCT03722446|147447761|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
73956012|NCT00991276|147447805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-27.1|STANDARD_ERROR_OF_MEAN|4.38|<|0.0001|TWO_SIDED|95.0|-35.78|-18.42||This analysis was step 1 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The least squares (LS) means and standard errors (SE) were used to test for a treatment difference and construct 2-sided 95% confidence intervals (CIs). The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.42|-35.78|<0.0001
73956013|NCT00991276|147447805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-26.93|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-35.54|-18.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.32|-35.54|<0.0001
73874083|NCT02714569|147290058|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|132.6|||||TWO_SIDED|90.0|90.5|194.4||||||Part B 300 mg LY||194.4|90.5|
73874084|NCT02714569|147290058|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|112.2|||||TWO_SIDED|90.0|93.2|135.1||||||Part B Overall||135.1|93.2|
73956014|NCT00991276|147447805|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|4.32||0.9684|TWO_SIDED|95.0|-8.72|8.38||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.38|-8.72|0.9684
73982246|NCT02068352|147510069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.09||||0.0594|TWO_SIDED|95.0|-4.27|0.08|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.08|-4.27|0.0594
73982247|NCT02068352|147510069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03||||0.396|TWO_SIDED|95.0|-3.43|1.37|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||1.37|-3.43|0.396
73982248|NCT02068352|147510069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.1135|TWO_SIDED|95.0|-4.26|0.46|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.46|-4.26|0.1135
73982249|NCT02068352|147510070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49||||0.1703|TWO_SIDED|95.0|-3.63|0.65|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||0.65|-3.63|0.1703
73874085|NCT02714569|147290059|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|97.3|||||TWO_SIDED|90.0|80.4|117.8||||||Part B Placebo||117.8|80.4|
73874086|NCT02714569|147290059|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|57.5|||||TWO_SIDED|90.0|31.3|106.0||||||||106.0|31.3|
73982250|NCT02068352|147510070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.56||||0.0176|TWO_SIDED|95.0|-4.67|-0.45|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.45|-4.67|0.0176
73982251|NCT02068352|147510070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.41||||0.2381|TWO_SIDED|95.0|-3.78|0.95|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||0.95|-3.78|0.2381
73982252|NCT02068352|147510070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.36||||0.047|TWO_SIDED|95.0|-4.68|-0.03|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.03|-4.68|0.047
73982253|NCT02068352|147510071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.8196|TWO_SIDED|95.0|-13.5|10.7|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||10.7|-13.5|0.8196
73982254|NCT02068352|147510071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.83||||0.0503|TWO_SIDED|95.0|-23.69|0.02|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.02|-23.69|0.0503
73982255|NCT02068352|147510071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68||||0.5902|TWO_SIDED|95.0|-17.22|9.85|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||9.85|-17.22|0.5902
73982256|NCT02068352|147510071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.42||||0.0482|TWO_SIDED|95.0|-26.73|-0.11|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||-0.11|-26.73|0.0482
73982257|NCT02068352|147510072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.8633|TWO_SIDED|95.0|-12.48|10.48|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||10.48|-12.48|0.8633
73982258|NCT02068352|147510072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.54||||0.0452|TWO_SIDED|95.0|-22.83|-0.25|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.25|-22.83|0.0452
73982259|NCT02068352|147510072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73||||0.6746|TWO_SIDED|95.0|-15.58|10.12|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||10.12|-15.58|0.6746
73982260|NCT02068352|147510072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.05||||0.0432|TWO_SIDED|95.0|-25.69|-0.4|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.4|-25.69|0.0432
74033730|NCT00506077|147620356|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
73874087|NCT02714569|147290059|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|96.2|||||TWO_SIDED|90.0|66.8|138.7||||||Part B 20 mg LY||138.7|66.8|
73874088|NCT02714569|147290059|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|80.9|||||TWO_SIDED|90.0|45.8|142.7||||||Part B 100 mg LY||142.7|45.8|
73874089|NCT02714569|147290059|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|108.2|||||TWO_SIDED|90.0|40.2|291.2||||||Part B 300 mg LY||291.2|40.2|
73874090|NCT02714569|147290059|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|87.9|||||TWO_SIDED|90.0|67.4|114.7||||||Part B Overall||114.7|67.4|
73874091|NCT02714569|147290060|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|96.0|||||TWO_SIDED|90.0|90.2|102.1||||||Part B Placebo||102.1|90.2|
73982261|NCT01322347|147510073|SUPERIORITY_OR_OTHER||Difference in LS Means between SFP & PBO|3.6|STANDARD_ERROR_OF_MEAN|1.39||0.011|TWO_SIDED|95.0||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA|||||||0.011
73982262|NCT00896389|147510088|OTHER|Association between genotypes and phenotypes were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
73982263|NCT00896389|147510089|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||<|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||||||<0.05
73982264|NCT00896389|147510090|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
73982265|NCT00896389|147510091|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
73982266|NCT00896389|147510092|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
73982267|NCT00896389|147510093|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
73982268|NCT00896389|147510094|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
73982269|NCT00896389|147510095|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
73982270|NCT00896389|147510096|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
73982271|NCT00896389|147510097|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05|||||||Chi-squared|Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
73982272|NCT00841321|147510133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1|TWO_SIDED|95.0|-0.5|0.1||Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||PASAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.1|-0.5|.1
73982273|NCT00841321|147510133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.9|-0.1||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||Stroop Exit Z-score least square means difference adjusted for baseline.Positive values indicate a beneficial effect from treatment with Ginkgo.||-0.1|-0.9|0.007
73982274|NCT00841321|147510133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5|TWO_SIDED|95.0|-0.2|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||COWAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.3|-0.2|0.5
73982275|NCT00841321|147510133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.5||95.0|-0.3|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||CVLT-II Delayed Recall Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.3|-0.3|0.5
73982276|NCT00841321|147510133|SUPERIORITY_OR_OTHER|||||||0.19|||||||MANCOVA|MANCOVA||MANCOVA for all four cognitive tests at exit adjusting for baseline. Individual ANOVAs were to follow if the multivariate test was significant.||||0.19
73982277|NCT00841321|147510134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.7||0.4|TWO_SIDED|95.0|-5.7|4.7|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Perceived Deficits Questionnaire||4.7|-5.7|0.4
73982278|NCT00841321|147510134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.0||0.7||95.0|-3.2|4.8|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Multiple Sclerosis Neuropsychological Questionnaire||4.8|-3.2|0.7
73982279|NCT00841321|147510134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.6||0.4||95.0|-1.3|0.8|||ANCOVA|||Community Integration Questionnaire||0.8|-1.3|0.4
73982280|NCT00379210|147510137|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANOVA|||Statistical tests are evaluated at an alpha level of 0.05 (corrected, when appropriate, for multiple comparisons). Analyses are performed on both response latency and accuracy on behavioral data. For latency analyses, mean response times for correct trials are calculated for each subject. Repeated-measures ANOVA are used for omnibus tests; paired t-tests are used for individual planned contrasts, with Bonferroni-corrected significance levels to maintain a .05 alpha level||||<0.01
73874092|NCT02714569|147290060|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|90.7|||||TWO_SIDED|90.0|59.8|137.6||||||Part B 5 mg LY||137.6|59.8|
73982281|NCT01358175|147510138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.2|6.42|||Regression, Logistic|||||6.42|2.20|<0.0001
73982282|NCT01358175|147510138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.89|||<|0.0001|TWO_SIDED|95.0|2.28|6.65|||Regression, Logistic|||||6.65|2.28|<0.0001
73982283|NCT01107912|147510153|NON_INFERIORITY_OR_EQUIVALENCE|The difference of median MPA to 20 μM ADP of a prasugrel 5-mg in the elderly group to the 75th percentile of the MPA to 20 μM ADP of a prasugrel 10 mg MD in the non-elderly group at the end of Period 1 was estimated from the observed data. The upper limit of the one-sided 97.5% confidence interval for the difference was estimated from resampling data with replacement through bootstrap methodology and was used to compare with the non-inferiority margin of 15 percentage points.|Estimate of the difference|6.0|||||TWO_SIDED|95.0|1.0|9.0||||||||9.00|1.00|
73982284|NCT00762853|147510167|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73982285|NCT02924051|147510168|EQUIVALENCE|With an alpha level of .05 and effective (post-attrition) sample size of approximately 25 participants per county, and 3 counties per treatment group, the power of the group comparison was at least 80%, assuming an ICC of .01 or less, and an observed difference in proportions of .25. The anticipated power for the longitudinal comparison of continuous outcomes was expected to be even greater under these assumptions given the greater power for the parametric tests.|Mean Difference (Final Values)|1.12||||0.26|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.26
73982286|NCT02924051|147510170|SUPERIORITY|||||||0.36|||||||t-test, 1 sided|||Comparison of Cooking Skills/Nutrition Education/MI at baseline and 12 months.||||0.36
73982287|NCT03905512|147510257|SUPERIORITY|Statistical significance was tested at a level of 0.05.||||||0.181|||||||Cochran-Mantel-Haenszel|||||||0.181
73982288|NCT00866619|147510297|SUPERIORITY|Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE \> 0.|Vaccine efficacy|55.8|||<|0.0001|TWO_SIDED|97.5|50.6|60.4|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus \[Hazard Ratio (HR) in GSK257049 \[5-17M\] Group (HR1) divided by HR in control VeroRab Comparator \[5-17M\] Group (HR2)\]; i. e. 1 - (HR1/HR2).||60.4|50.6|<0.0001
73874093|NCT02714569|147290060|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|99.9|||||TWO_SIDED|90.0|75.9|131.5||||||Part B 20 mg LY||131.5|75.9|
73982289|NCT00866619|147510298|SUPERIORITY|Point estimate of efficacy was adjusted for study site as stratification factor for the analysis. Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE \> 0.|Vaccine efficacy|31.315|||<|0.0001|TWO_SIDED|97.5|23.556|38.286|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus \[Hazard Ratio (HR) in GSK257049 \[6-12W\] Group (HR1) divided by HR in control Menjugate Comparator \[6-12W\] Group (HR2)\]; i. e. 1 - (HR1/HR2).||38.286|23.556|<0.0001
73982290|NCT00645411|147510364|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine was considered non-inferior to egg-derived vaccine in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.72|1.01|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay||1.01|0.72|
73874094|NCT02714569|147290060|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|91.0|||||TWO_SIDED|90.0|67.5|122.7||||||Part B 100 mg LY||122.7|67.5|
73874095|NCT02714569|147290060|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|87.0|||||TWO_SIDED|90.0|42.0|180.5||||||Part B 300 mg LY||180.5|42.0|
73982291|NCT00645411|147510364|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV) in postvaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs(cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.59|||||TWO_SIDED|95.0|0.49|0.72|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.||0.72|0.49|
73982292|NCT00645411|147510364|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.56|||||TWO_SIDED|95.0|0.46|0.68|||ANOVA|||Non-inferiority of cTIV to eTIV against influenza B strain as measured by HI egg-derived antigen assay.||0.68|0.46|
73982293|NCT00645411|147510364|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV) in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.92|||||TWO_SIDED|95.0|0.79|1.08|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.||1.08|0.79|
73982294|NCT00645411|147510364|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.65|||||TWO_SIDED|95.0|0.54|0.78|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.||0.78|0.54|
73982295|NCT00645411|147510364|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV)was \>0.667.|Ratio of GMTs|0.87|||||TWO_SIDED|95.0|0.71|1.06|||ANOVA|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.||1.06|0.71|
73982296|NCT00645411|147510365|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference in % (cTIV minus eTIV)|-1.0|||||TWO_SIDED|95.0|-4.0|1.0|||binomial or the method of Miettinen and|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay.||1|-4|
73982297|NCT00645411|147510365|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV - eTIV)|-9.0|||||TWO_SIDED|95.0|-13.0|-4.0|||binomial or Miettinen & Nurimen method|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.||-4|-13|
73982298|NCT00645411|147510365|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|-15.0|||||TWO_SIDED|95.0|-21.0|-9.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI egg-derived antigen assay.||-9|-21|
73982299|NCT00645411|147510365|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%|Difference % (cTIV minus eTIV)|-1.0|||||TWO_SIDED|95.0|-3.0|2.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.||2|-3|
73982300|NCT00645411|147510365|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|-5.0|||||TWO_SIDED|95.0|-9.5|0.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.||0|-9.5|
73982301|NCT00645411|147510365|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|0.0|||||TWO_SIDED|95.0|-6.0|6.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.||6|-6|
73982302|NCT02138838|147510399|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|8.1||||0.48|TWO_SIDED|95.0|-13.7|29.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC|||29.9|-13.7|0.48
73982303|NCT02138838|147510400|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-9.9||||0.42|TWO_SIDED|95.0|-33.3|13.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by baseline age group (6-\<12 years, 12-\<18 years)|SOC+Cinacalcet - SOC|A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints. The primary endpoint was tested at a 2-sided significance level of 0.05. The secondary endpoints were tested using Holm's method at 0.05 (2-sided) should the primary endpoint achieve a significant result.||13.4|-33.3|0.42
73982304|NCT02138838|147510401|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-10.4||||0.25|TWO_SIDED|95.0|-27.7|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC|||6.8|-27.7|0.25
73982305|NCT02138838|147510402|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.0||||0.23|TWO_SIDED|95.0|-12.5|50.5|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC|||50.5|-12.5|0.23
73982306|NCT02138838|147510403|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.34||||0.059|TWO_SIDED|95.0|-0.7|0.01|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.||||0.01|-0.70|0.059
73982307|NCT02138838|147510404|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.76||||0.039|TWO_SIDED|95.0|0.04|1.48|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC|||1.48|0.04|0.039
73982308|NCT01867307|147510405|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-220.0|STANDARD_ERROR_OF_MEAN|55.5|<|0.0001|TWO_SIDED|95.0|-440.6|-202.7||P-value is from a paired t-test.|Paired t- test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.||-202.7|-440.6|<0.0001
73982309|NCT01867307|147510405|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-234.0|STANDARD_ERROR_OF_MEAN|25.8|<|0.0001|TWO_SIDED|95.0|-312.3|-201.5||P-value is from a paired t-test|Paired t-test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.||-201.5|-312.3|<0.0001
73982310|NCT00623714|147510417|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.34||||0.011|TWO_SIDED|90.0|0.16|0.7||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.70|0.16|0.011
73982311|NCT00623714|147510418|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.4||||0.002|TWO_SIDED|95.0|0.26|0.63||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.63|0.26|0.002
73982312|NCT00267774|147510434|OTHER||||||<|0.0001||||||A 2-sided value of P\<0.05 was considered to indicate statistical significance.|t-test, 2 sided|||||||<0.0001
73982313|NCT03444298|147510435|SUPERIORITY|||||||0.67||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.67
73982314|NCT03444298|147510436|SUPERIORITY|||||||0.43||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.43
73982315|NCT03444298|147510437|SUPERIORITY|||||||0.27||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.27
73982316|NCT03444298|147510438|SUPERIORITY|||||||0.92||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.92
73982317|NCT03444298|147510439|SUPERIORITY|||||||0.99||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.99
73982318|NCT03444298|147510439|SUPERIORITY|||||||0.04||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.04
73982319|NCT03444298|147510440|SUPERIORITY|||||||0.98||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.98
73982320|NCT03444298|147510440|SUPERIORITY|||||||0.02||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.02
73982321|NCT03444298|147510441|SUPERIORITY|||||||0.84||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.84
73874096|NCT02714569|147290060|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|93.5|||||TWO_SIDED|90.0|81.8|106.9||||||Part B Overall||106.9|81.8|
73874097|NCT01843023|147290067|SUPERIORITY||Mean Difference (Final Values)|0.558|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73982322|NCT03444298|147510442|SUPERIORITY|||||||0.59||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.59
73982323|NCT03444298|147510443|SUPERIORITY|||||||0.83||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.83
73982324|NCT03444298|147510444|SUPERIORITY|||||||0.51||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.51
73982325|NCT03444298|147510445|SUPERIORITY|||||||0.48||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.48
73982326|NCT03444298|147510446|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||<0.01
73982327|NCT03444298|147510447|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||<0.0001
73982328|NCT00760877|147510448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.096||||0.1083|TWO_SIDED|95.0|0.766|5.738|||Cochran-Mantel-Haenszel|||||5.738|0.766|0.1083
73982329|NCT05356130|147510481|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||"We conducted the same two independent planned comparisons: Enhanced BLT Encouragement + Adherence Promotion compared to Minimal BLT Encouragement; Minimal BLT Encouragement and Enhanced BLT Encouragement + Adherence Promotion compared to TAU."||||0.014
73982330|NCT03141177|147510482|SUPERIORITY|Treatment A over Treatment C|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.64|||Stratified Log-Rank|||||0.64|0.41|<0.0001
73982331|NCT03141177|147510483|SUPERIORITY|Treatment A over Treatment C|Hazard Ratio (HR)|0.6||||0.001|TWO_SIDED|98.89|0.4|0.89|||Stratified Log-Rank|||||0.89|0.40|0.0010
73982332|NCT03141177|147510484|SUPERIORITY|Treatment A over Treatment C|Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.51|4.95|||Stratified Cochran-Mantel-Haenszel|||||4.95|2.51|<0.0001
73982333|NCT03141177|147510484|OTHER|Treatment A - Treatment C|Difference of Objective Response Rates|28.6|||||TWO_SIDED|95.0|21.7|35.6|||||Strata adjusted difference in objective response rate (Nivolumab+Cabozantinib - Sunitinib) based on DerSimonian and Laird.|||35.6|21.7|
73982334|NCT02680314|147510492|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
73982335|NCT05361304|147510503|NON_INFERIORITY||Least square Mean (LSM) Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.012|||TWO_SIDED|95.0|-0.04|0.0|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under HLLC.||0.000|-0.040|
73982336|NCT05361304|147510503|NON_INFERIORITY||Least square Mean (LSM) Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.012|||TWO_SIDED|95.0|-0.03|0.02|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under LLHC.||0.020|-0.030|
73982337|NCT05361304|147510504|NON_INFERIORITY||Least square Mean (LSM) Difference|0.27|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.46|1.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology.||1.010|-0.460|
73982338|NCT05361304|147510505|NON_INFERIORITY||LSM Difference|4.0|STANDARD_ERROR_OF_MEAN|4.06|||TWO_SIDED|95.0|-4.1|12.0|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|||12.0|-4.1|
73982339|NCT05361304|147510506|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the confidence interval of the mean difference between Senofilcon A contact lenses made with a novel manufacturing technology and Senofilcon A contact lenses made with the current manufacturing technology is greater than -5.|LSM Differences|-0.3|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-7.1|6.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|||6.5|-7.1|
73982340|NCT04883541|147510539|SUPERIORITY|the t-test in independent groups|Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.8|<|0.05|TWO_SIDED|0.05|||||t-test, 2 sided|||||||<0.05
73982341|NCT04239911|147510543|EQUIVALENCE|A p\<0.05 considered the threshold for statistical significance.|Odds Ratio (OR)|0.97||||0.974|TWO_SIDED|95.0|0.14|6.85|||Regression, Logistic||The comparison group is enhanced usual care arm|"Outcome measures workers' intentions of leaving their current job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept."||6.85|0.14|0.974
73982342|NCT04239911|147510543|EQUIVALENCE|A p\< 0.05 considered the threshold for statistical significance|Odds Ratio (OR)|0.8||||0.846|TWO_SIDED|95.0|0.08|7.72|||Regression, Logistic||The comparison group is enhanced usual care arm|"Outcome measures workers' intentions of searching for a new job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept."||7.72|0.08|0.846
73982343|NCT04239911|147510546|EQUIVALENCE|A p\<0.05 was considered the threshold for statistical significance.|Odds Ratio (OR)|0.18||||0.043|TWO_SIDED|95.0|0.03|0.94|||Regression, Logistic||The comparison group is enhanced usual care arm|"Preventable 911 calls if had been able to reach the doctor. Dichotomized into agree, strongly agree, and very strongly vs. all other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept."||0.94|0.03|0.043
73982344|NCT04239911|147510546|EQUIVALENCE|A p\<0.05 considered the threshold for statistical significance.|Odds Ratio (OR)|1.01||||0.99|TWO_SIDED|95.0|0.22|4.58|||Regression, Logistic|||"Preventable 911 calls if had been able to reach the nurse/supervisor. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept."||4.58|0.22|0.99
73982345|NCT01580306|147510547|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|113.57|STANDARD_DEVIATION|93.2|||TWO_SIDED|90.0|41.58|310.17|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal||310.17|41.58|
73982346|NCT01580306|147510547|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|178.31|STANDARD_DEVIATION|78.9|||TWO_SIDED|90.0|85.23|373.03|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal||373.03|85.23|
73982347|NCT01580306|147510547|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|169.21|STANDARD_DEVIATION|97.7|||TWO_SIDED|90.0|73.19|391.17|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal||391.17|73.19|
73982348|NCT01580306|147510548|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|107.22|STANDARD_DEVIATION|107.7|||TWO_SIDED|90.0|35.16|327.01|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal||327.01|35.16|
73982349|NCT01580306|147510548|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|175.52|STANDARD_DEVIATION|70.4|||TWO_SIDED|90.0|89.55|344.06|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal||344.06|89.55|
73874098|NCT01843023|147290069|SUPERIORITY||Mean Difference (Final Values)|0.722|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73982350|NCT01580306|147510548|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|120.98|STANDARD_DEVIATION|115.0|||TWO_SIDED|90.0|47.257|309.736|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal||309.736|47.257|
73982351|NCT00065611|147510563|SUPERIORITY_OR_OTHER|||||||0.9074||95.0|||||Chi-squared|||||||0.9074
73982352|NCT00065611|147510564|SUPERIORITY_OR_OTHER|||||||0.4566||95.0|||||ANOVA|||||||0.4566
73982353|NCT00065611|147510565|SUPERIORITY_OR_OTHER|||||||0.3792||95.0|||||ANOVA|||||||0.3792
73982354|NCT05072795|147510571|OTHER|||||||0.005|||||||t-test, 2 sided|||||||0.005
73982355|NCT01124916|147510587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8728.0|STANDARD_ERROR_OF_MEAN|853.129|<|0.001|TWO_SIDED|95.0|7028.846|10427.154|||t-test, 2 sided|||The null hypothesis is that there is no difference in the total cost of care between standard and robotic-assisted laparoscopic abdominal sacrocolpopexy six weeks after surgery.||10427.154|7028.846|<.001
73874099|NCT03838978|147290120|SUPERIORITY|Non-inferiority is demonstrated if the 90% LB \> -10.0%. If non-inferiority was met, superiority could be tested. Superiority is demonstrated if 97.5% LB \> 0.0%.||||||||||||||||For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis.|Device group differences and two-sided 90% and 97.5% confidence interval lower bounds (LB) adjusting for propensity score (PS) subclass based on PS subclass weights (ATT). Noninferiority is demonstrated if the 90% LB \> -10.0%. Superiority is demonstrated if 97.5% LB \>0.0%. Two-sided 97.5% LB is evaluated rather than two-sided 95.0% LB since the superiority type 1 error is split between testing superiority in terms of Month 24 CCS and then separately for a set of superiority secondary endpoints with type 1 error control maintained through the use of Hochberg approach (following demonstration of non-inferiority).|||
73874100|NCT01450761|147290219|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.3775|TWO_SIDED|95.0|0.807|1.085|||Log Rank||HR = ipilimumab over placebo|||1.085|0.807|0.3775
73874101|NCT01450761|147290220|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.961||||0.5678|TWO_SIDED|95.0|0.838|1.102|||Log Rank||HR = ipilimumab over placebo|||1.102|0.838|0.5678
73874102|NCT01450761|147290221|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.851||||0.0161|TWO_SIDED|95.0|0.747|0.971|||Log Rank||HR = ipilimumab over placebo|||0.971|0.747|0.0161
73956015|NCT00991276|147447806|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.68|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-5.44|-1.92||This analysis was step 2 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.92|-5.44|<0.0001
73956016|NCT00991276|147447806|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.88||0.1541|TWO_SIDED|95.0|-0.48|3.01||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.01|-0.48|0.1541
73956017|NCT00991276|147447806|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-6.68|-3.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.21|-6.68|<0.0001
73956018|NCT00991276|147447807|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|30.81|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.14|45.49||This analysis was step 3 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||45.49|16.14|<0.0001
73956019|NCT00991276|147447807|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|26.79|STANDARD_ERROR_OF_MEAN|7.34||0.0004|TWO_SIDED|95.0|12.26|41.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||41.32|12.26|0.0004
73956020|NCT00991276|147447807|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.03|STANDARD_ERROR_OF_MEAN|7.27||0.5807|TWO_SIDED|95.0|-10.36|18.41||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||18.41|-10.36|0.5807
73956021|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|2.09||0.0076|TWO_SIDED|95.0|-9.8|-1.54||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.54|-9.80|0.0076
73956022|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.32|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.43|-6.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-6.21|-14.43|<0.0001
73956023|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.65|STANDARD_ERROR_OF_MEAN|2.06||0.0257|TWO_SIDED|95.0|0.58|8.73||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.73|0.58|0.0257
73982356|NCT01124916|147510588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.2|STANDARD_ERROR_OF_MEAN|7.846||0.43|TWO_SIDED|95.0|-21.769|9.369|||t-test, 2 sided|||The null hypothesis is that there is no difference in urinary distress between women assigned to LASC and those assigned to RASC six months after intervention as measured by the UDI.||9.369|-21.769|.43
73982357|NCT00887471|147510592|SUPERIORITY_OR_OTHER|||||||0.59||||||A priori threshold for statistical significance was P\<.05.|Mixed Models Analysis|||The relationship of surgical group with AHI change was evaluated by constructing a mixed linear model (MLM). The dependent variable was the logarithm of the ratio of postoperative AHI score to preoperative AHI score; this transformation was chosen in order to minimize skew of model residuals. Surgical group was introduced as a fixed factor; subject pairs constituted levels of a random blocking) factor.||||.590
73982358|NCT00887471|147510592|SUPERIORITY_OR_OTHER|||||||0.022||||||P value for the variances. The a priori threshold for statistical significance was P \< .05.|Mixed Models Analysis|||A mixed linear model was constructed as described above. Variance was estimated separately for each group.||||.022
73982359|NCT00887471|147510593|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||The relationship of surgical group with postoperative AHI ≤ 5 was evaluated by exact conditional logistic regression, predicting AHI ≤ 5 from surgical group with subject pairs as strata.||||1.00
73982360|NCT03014726|147510597|OTHER|Recurrence \< 0.5 as defined by an IPSS score of less than or equal to 11. The performance goal is met if the upper limit of the one-sided 95% confidence interval for recurrence is less than 50%.|||||<|0.001|||||||1-sample binomial z-test|||||||<0.001
73982361|NCT00901459|147510606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|0.44||0.014|TWO_SIDED|95.0|0.51|2.43||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=14|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (Frequency control)and the corresponding craving change in the 1Hz sfg condition (active).|A pairwise t-test was performed to contrast the active rTMS condition with the frequency control condition.||2.43|0.51|0.014
73982362|NCT00901459|147510606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.4||0.49|TWO_SIDED|95.0|-0.64|1.22|||t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 1Hz sfg condition (active)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the active rTMS condition with the location control condition.||1.22|-0.64|0.49
73982363|NCT00901459|147510606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|0.44||0.09|TWO_SIDED|95.0|0.52|1.39||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (frequency control)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the location control rTMS condition with the frequency control condition.||1.39|0.52|0.09
73982364|NCT00848198|147510627|SUPERIORITY_OR_OTHER||Sensitivity|87.1|||||TWO_SIDED|95.0|83.2|90.9||||||||90.9|83.2|
73982365|NCT00848198|147510627|SUPERIORITY_OR_OTHER||Specificity|72.0|||||TWO_SIDED|95.0|66.9|77.1||||||||77.1|66.9|
74033731|NCT00506077|147620357|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Logitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
74033732|NCT00316303|147620362|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
74033733|NCT00316303|147620363|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
74033734|NCT00316303|147620364|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
73982366|NCT00848198|147510628|SUPERIORITY_OR_OTHER||Sensitivity|39.7|||||TWO_SIDED|95.0|34.2|45.3||||||||45.3|34.2|
73982367|NCT00848198|147510628|SUPERIORITY_OR_OTHER||Specificity|82.7|||||TWO_SIDED|95.0|78.4|87.0||||||||87.0|78.4|
74033735|NCT00316303|147620365|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wald Chi-squared|||||||0.011
74033736|NCT00316303|147620366|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.6
73982368|NCT00848198|147510629|SUPERIORITY_OR_OTHER||Sensitivity|71.9|||||TWO_SIDED|95.0|66.8|77.0||||||||77.0|66.8|
73982369|NCT00848198|147510629|SUPERIORITY_OR_OTHER||Specificity|82.7|||||TWO_SIDED|95.0|78.4|87.0||||||||87.0|78.4|
73982370|NCT00848198|147510630|SUPERIORITY_OR_OTHER||Sensitivity|27.2|||||TWO_SIDED|95.0|22.2|32.3||||||||32.3|22.2|
73982371|NCT00848198|147510630|SUPERIORITY_OR_OTHER||Specificity|98.7|||||TWO_SIDED|95.0|97.4|100.0||||||||100.0|97.4|
73982372|NCT00848198|147510631|SUPERIORITY_OR_OTHER||Sensitivity|51.3|||||TWO_SIDED|95.0|45.7|57.0||||||||57.0|45.7|
73982373|NCT00848198|147510631|SUPERIORITY_OR_OTHER||Specificity|94.7|||||TWO_SIDED|95.0|92.1|97.2||||||||97.2|92.1|
73982374|NCT00848198|147510632|SUPERIORITY_OR_OTHER||Sensitivity|61.2|||||TWO_SIDED|95.0|55.6|66.7||||||||66.7|55.6|
73982375|NCT00848198|147510632|SUPERIORITY_OR_OTHER||Specificity|78.7|||||TWO_SIDED|95.0|74.0|83.3||||||||83.3|74.0|
73982376|NCT00848198|147510633|SUPERIORITY_OR_OTHER||Sensitivity|58.5|||||TWO_SIDED|95.0|52.9|64.1||||||||64.1|52.9|
73982377|NCT00848198|147510633|SUPERIORITY_OR_OTHER||Specificity|73.3|||||TWO_SIDED|95.0|68.3|78.3||||||||78.3|68.3|
73982378|NCT02066389|147510728|SUPERIORITY|||||||0.153||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.153
73982379|NCT02066389|147510728|SUPERIORITY|||||||0.018||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.018
73982380|NCT02066389|147510728|SUPERIORITY|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.001
73982381|NCT02066389|147510728|SUPERIORITY|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.008
73982382|NCT02066389|147510728|SUPERIORITY|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.001
73982383|NCT02066389|147510729|SUPERIORITY|||||||0.034||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.034
73982384|NCT02066389|147510729|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
73956024|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.7|STANDARD_ERROR_OF_MEAN|6.05||0.0003|TWO_SIDED|95.0|10.74|34.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||34.67|10.74|0.0003
73956025|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.47|STANDARD_ERROR_OF_MEAN|6.0||0.0174|TWO_SIDED|95.0|-26.35|-2.59||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.59|-26.35|0.0174
73956026|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|37.17|STANDARD_ERROR_OF_MEAN|5.96|<|0.0001|TWO_SIDED|95.0|25.38|48.96||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||48.96|25.38|<0.0001
73956027|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|20.93|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED|95.0|12.61|29.25||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||29.25|12.61|<0.0001
73956028|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.1|STANDARD_ERROR_OF_MEAN|4.18|<|0.0001|TWO_SIDED|95.0|23.83|40.36||This analysis was step 4 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||40.36|23.83|<0.0001
73956029|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-11.17|STANDARD_ERROR_OF_MEAN|4.14||0.008|TWO_SIDED|95.0|-19.37|-2.97||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.97|-19.37|0.0080
73956030|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.97|STANDARD_ERROR_OF_MEAN|2.85||0.0834|TWO_SIDED|95.0|-10.61|0.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.67|-10.61|0.0834
73956031|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|18.59|STANDARD_ERROR_OF_MEAN|2.83|<|0.0001|TWO_SIDED|95.0|12.99|24.19||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||24.19|12.99|<0.0001
73956032|NCT00991276|147447808|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-23.56|STANDARD_ERROR_OF_MEAN|2.81|<|0.0001|TWO_SIDED|95.0|-29.12|-18.01||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.01|-29.12|<0.0001
73982385|NCT02066389|147510729|SUPERIORITY|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.002
73982386|NCT02066389|147510729|SUPERIORITY|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.010
73982387|NCT02066389|147510729|SUPERIORITY|||||||0.012||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.012
73982388|NCT02066389|147510730|SUPERIORITY|||||||0.023||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.023
73982389|NCT02066389|147510730|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
73982390|NCT02066389|147510730|SUPERIORITY|||||||0.145||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.145
73982391|NCT02066389|147510730|SUPERIORITY|||||||0.007||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.007
73982392|NCT02066389|147510730|SUPERIORITY|||||||0.014||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.014
73982393|NCT02066389|147510731|SUPERIORITY|||||||0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.005
73982394|NCT02066389|147510731|SUPERIORITY||||||<|0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||<0.001
73982395|NCT02066389|147510731|SUPERIORITY|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.010
73982396|NCT02066389|147510731|SUPERIORITY|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.002
73982397|NCT02066389|147510731|SUPERIORITY|||||||0.024||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.024
73982398|NCT02066389|147510732|SUPERIORITY|||||||0.015||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.015
73982399|NCT02066389|147510732|SUPERIORITY|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.008
73982400|NCT02066389|147510732|SUPERIORITY|||||||0.029||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.029
73982401|NCT02066389|147510732|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
73982402|NCT02066389|147510732|SUPERIORITY|||||||0.343||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.343
73982403|NCT02066389|147510733|SUPERIORITY|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.039
74033737|NCT01753076|147620367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.0||||0.12|TWO_SIDED|95.0|-67.9|7.9|||ANCOVA||A negative mean difference means that the direction of effect is in favor of placebo.|||7.9|-67.9|0.120
74033738|NCT01753076|147620368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.139|TWO_SIDED|95.0|-3.1|0.4|||Mixed Models Analysis|||||0.4|-3.1|0.139
74033739|NCT01753076|147620369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.173|TWO_SIDED|95.0|-0.3|0.05|||Random coefficients analysis|||||0.05|-0.30|0.173
74033740|NCT01753076|147620370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.127||||0.265|TWO_SIDED|95.0|-0.351|0.097|||Mixed Models Analysis|||||0.097|-0.351|0.265
73982404|NCT02066389|147510733|SUPERIORITY|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.039
73982405|NCT02066389|147510733|SUPERIORITY|||||||0.046||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.046
73982406|NCT02066389|147510733|SUPERIORITY|||||||0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.005
73982407|NCT02066389|147510733|SUPERIORITY|||||||0.096||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.096
73982408|NCT02066389|147510734|SUPERIORITY|||||||0.269||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.269
73982409|NCT02066389|147510734|SUPERIORITY|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.160
73982410|NCT02066389|147510734|SUPERIORITY|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||1.000
73982411|NCT02066389|147510734|SUPERIORITY|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.160
73982412|NCT02066389|147510734|SUPERIORITY|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||1.000
73982413|NCT02907489|147510735|SUPERIORITY|||||||0.083||||||0.083 for 24 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.083
73982414|NCT02907489|147510735|SUPERIORITY|||||||0.041||||||0.041 for 48 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.041
73982415|NCT02907489|147510735|SUPERIORITY|||||||0.063||||||0.063 for 72 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.063
73982416|NCT02907489|147510736|SUPERIORITY|||||||0.982||||||0.982 for S1, Significant at P ≤ 0.05|Chi-squared|||||||0.982
73982417|NCT02907489|147510736|SUPERIORITY|||||||0.467||||||0.467 for S2, Significant at P ≤ 0.05|Chi-squared|||||||0.467
73982418|NCT02907489|147510736|SUPERIORITY|||||||0.01||||||0.01 for S3 Significant at P ≤ 0.05|Chi-squared|||||||0.01
73982419|NCT01755598|147510737|OTHER|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, is to be above 0%.|Vaccine efficacy rate|49.7||||0.043|TWO_SIDED|90.0|12.1|71.2|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, as compared to placebo.||71.2|12.1|0.0430
73982420|NCT01755598|147510738|OTHER|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. If the primary objective is met, this secondary objective is to be analysed using the following success criterion: The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV infection, meeting the case definition 2, is to be above 0%.|Vaccine efficacy rate|61.67||||0.021|TWO_SIDED|90.0|24.084|80.647|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite Xpert MTB/Rif positive pulmonary TB disease not associated with HIV-infection, meeting the case definition 2, as compared to placebo.||80.647|24.084|0.0210
73982421|NCT00828178|147510757|SUPERIORITY_OR_OTHER|||||||0.87|||||||t-test, 2 sided|||Statistical analysis system (SAS) software was used (SAS Institute Inc. Cary, North Carolina, SAS 9.2). Baseline demographic and clinical characteristics were summarized using appropriate descriptive statistics and compared across treatment groups using Chi-square. Two-sample t tests were used in the statistical analysis of the FMD outcomes. ANCOVA was used to compare the groups with respect to changes in clinical variables adjusting for baseline values.||||0.87
73982422|NCT00828178|147510758|SUPERIORITY_OR_OTHER|||||||0.1801||||||This Statistical Analysis applies category SELENA-SLEDAI|t-test, 2 sided|||||||0.1801
73982423|NCT05062343|147510767|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
73982424|NCT05062343|147510768|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73982425|NCT05062343|147510769|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
73982426|NCT05062343|147510770|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
73982427|NCT05062343|147510771|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
73982428|NCT05062343|147510772|SUPERIORITY|||||||0.045|||||||Chi-squared|||||||0.045
73982429|NCT05062343|147510773|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73982430|NCT05062343|147510774|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73982431|NCT00780741|147510775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.09|TWO_SIDED|95.0|-0.01|0.21|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the proportion with success in immediate group minus proportion with success in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||0.21|-0.01|0.09
73982432|NCT00780741|147510776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-139.0||||0.24|TWO_SIDED|95.0|-377.0|94.0|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average cost in immediate group minus average cost in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||94|-377|0.24
73982433|NCT00780741|147510777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-4.0|-1.8|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average months of symptoms in immediate group minus average months of symptoms in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||-1.8|-4.0|<0.0001
73956033|NCT00991276|147447809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.67|STANDARD_ERROR_OF_MEAN|0.99||0.0077|TWO_SIDED|95.0|-4.63|-0.72||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.72|-4.63|0.0077
73982434|NCT03677986|147510808|SUPERIORITY||Odds Ratio (OR)|0.92||||0.914|TWO_SIDED|95.0|0.21|4.14|||GEE|||||4.14|.21|0.914
73982435|NCT00424502|147510811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.017|STANDARD_DEVIATION|1.34|<|0.0001|TWO_SIDED|95.0|1.39|2.64|||t-test, 2 sided|||Change from Baseline to Week 24||2.64|1.39|<0.0001
73982436|NCT00424502|147510812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_DEVIATION|0.259|<|0.0001|TWO_SIDED|95.0|0.151|0.401|||t-test, 2 sided|||Change from baseline to Week 24||0.401|0.151|<0.0001
73982437|NCT00424502|147510815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4|STANDARD_DEVIATION|23.24||0.012|TWO_SIDED|95.0|3.52|25.28|||t-test, 2 sided|||Change from baseline to Week 24||25.28|3.52|0.012
74033741|NCT01753076|147620371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.125|TWO_SIDED|95.0|-18.7|2.3|||Mixed Models Analysis|||||2.3|-18.7|0.125
74033742|NCT01753076|147620372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.393|TWO_SIDED|95.0|0.36|1.49|||Regression, Logistic|||||1.49|0.36|0.393
73982438|NCT00424502|147510816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|STANDARD_DEVIATION|8.21||0.337|TWO_SIDED|95.0|-2.03|5.65|||t-test, 2 sided|||Change from baseline to Week 24||5.65|-2.03|0.337
73982439|NCT04198428|147510817|SUPERIORITY||Odds Ratio (OR)|1.49|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
73982440|NCT04198428|147510818|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
73982441|NCT04198428|147510819|SUPERIORITY||Odds Ratio (OR)|1.43|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
73982442|NCT04198428|147510820|SUPERIORITY||Risk Ratio (RR)|0.99|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Zero-inflated negative binomial mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
73982443|NCT04198428|147510821|SUPERIORITY||Risk Ratio (RR)|0.93|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors||||||<0.05
73982444|NCT04198428|147510822|SUPERIORITY||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors||||||<0.05
73982445|NCT04198428|147510823|SUPERIORITY||Mean Difference (Net)|-1068.0|||<|0.05|TWO_SIDED||||||Mixed Models Analysis||Generalized estimating equation comparing post- to pre-index costs in OUD-CDS vs. Usual Care, adjusted for site and balancing factors|||||<0.05
73982446|NCT04198428|147510824|SUPERIORITY||Odds Ratio (OR)|1.06|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
73982447|NCT04198428|147510825|SUPERIORITY||Risk Ratio (RR)|1.08|||<|0.05|TWO_SIDED||||||Mixed Models Analysis||Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors|||||<0.05
73982448|NCT00267956|147510870|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The study is designed to maintain a Type I error of 0.05 or less for the primary analysis|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by subject's prior anti-Tumor Necrosis Factor (TNF) exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05. Sample Size and power: With 70 partcipants in each treatment group, 5000 repetitions. Assuming a 20% ACR20 response in placebo participants regardless of prior anti-TNF exposure and a 35% ACR 20 and 45% ACR20 response in ustekinumab group for participants who had prior anti-TNF exposure, and who had no prior anti-TNF exposures, the power to detect the treatment difference is 0.85.||||<0.001
74033743|NCT01753076|147620373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.986|TWO_SIDED|95.0|0.34|2.89|||Regression, Cox||Week 48|||2.89|0.34|0.986
74033744|NCT01753076|147620373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.923|TWO_SIDED|95.0|0.53|2.01|||Chi-squared||Week 60|||2.01|0.53|0.923
74033745|NCT01753076|147620374|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.642|TWO_SIDED|95.0|0.81|1.42|||Regression, Cox|||||1.42|0.81|0.642
74033746|NCT01753076|147620375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|||||TWO_SIDED|95.0|-0.062|0.053||||||||0.053|-0.062|
74033747|NCT01753076|147620376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-2.8|5.5||||||||5.5|-2.8|
74033748|NCT01212172|147620377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9||||0.2879|TWO_SIDED|95.0|-6.7|21.1|||t-test, 1 sided|||||21.1|-6.7|0.2879
74033749|NCT02868216|147620412|OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|0.84||0.05|TWO_SIDED|95.0|0.63|3.98|||ANOVA|||||3.98|0.63|0.05
73982449|NCT00267956|147510871|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between Group II and Group I at a significant level of 0.05.||||0.004
73982450|NCT00267956|147510872|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||0.005
73982451|NCT00267956|147510873|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||<0.001
74033750|NCT02702193|147620413|SUPERIORITY||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|||||Generalized Estimating Equations (GEE)|GEE allowed the examination of trajectories from baseline through the 12 month follow-up.||To determine sample size for the grant proposal we conducted simulation studies in Mplus (Muthén \& Muthén, 2010) following the procedure described by Muthén and Muthén (2002). Each simulation created 10,000 datasets, assuming a medium-size (d = .5) intervention effect, and attrition of 10% at each assessment. For α= .05, the power estimate was at or above 80% with a sample of 172 mothers.||||<.05
74033751|NCT00904826|147620437|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between before treatment and one year after treatment.||||<0.0001
74033752|NCT00904826|147620439|SUPERIORITY_OR_OTHER|||||||0.0078||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison was made between baseline and after 12 months of treatment.||||0.0078
74033753|NCT00904826|147620443|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 weeks and baseline.||||<0.0001
74033754|NCT00904826|147620443|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 3 months and baseline.||||<0.0001
74033755|NCT00904826|147620443|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 months and baseline||||0.0001
74033756|NCT00904826|147620443|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 9 months and baseline.||||0.0001
74033757|NCT00904826|147620443|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 12 months and baseline.||||<0.0001
74033758|NCT00904826|147620445|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison was between 3 months and baseline.||||0.0019
74033759|NCT03345836|147620514|SUPERIORITY||Adjusted Risk Difference|17.9|||<|0.0001|TWO_SIDED|95.0|10.0|25.8||P-value was calculated using Cochran-Mantel Haenszel (CMH) test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% confidence interval (CI) were calculated using CMH risk difference estimate.|||25.8|10.0|<0.0001
74033760|NCT03345836|147620515|SUPERIORITY||Adjusted Risk Difference|31.2|||<|0.0001|TWO_SIDED|95.0|25.5|37.0||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH risk difference estimate.|||37.0|25.5|<0.0001
74033761|NCT03345836|147620517|SUPERIORITY||Adjusted Treatment Difference|25.9|||<|0.0001|TWO_SIDED|95.0|18.7|33.1||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||33.1|18.7|<0.0001
74033762|NCT03345836|147620518|SUPERIORITY||Adjusted Treatment Difference|16.8|||<|0.0001|TWO_SIDED|95.0|12.0|21.6||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||21.6|12.0|<0.0001
74033763|NCT03345836|147620519|SUPERIORITY||Adjusted Treatment Difference|22.5||||0.0001|TWO_SIDED|95.0|11.1|34.0||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||34.0|11.1|0.0001
73982452|NCT00267956|147510874|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||<0.001
73982453|NCT00267956|147510875|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at asignificant level of 0.05.||||<0.001
73982454|NCT01263223|147510876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|||<|0.0001|TWO_SIDED|95.0|7.4|12.0||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||12.0|7.4|<0.0001
73982455|NCT01263223|147510876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4|||<|0.0001|TWO_SIDED|95.0|17.9|30.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||30.9|17.9|<0.0001
73982456|NCT01263223|147510877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|||<|0.0001|TWO_SIDED|95.0|3.9|8.8||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis|||||8.8|3.9|<0.0001
73982457|NCT01263223|147510877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.0025|TWO_SIDED|95.0|2.6|11.6||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis|||||11.6|2.6|0.0025
73982458|NCT01263223|147510877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.51|||<|0.0001|TWO_SIDED|95.0|3.81|7.21||P-value is for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis|||||7.21|3.81|<0.0001
73982459|NCT01263223|147510877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66||||0.002|TWO_SIDED|95.0|2.13|9.2||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis|||||9.20|2.13|0.0020
73982460|NCT01263223|147510878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.0224|TWO_SIDED|95.0|0.418|5.38||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis|||||5.38|0.418|0.0224
73982461|NCT01263223|147510878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7||||0.2453|TWO_SIDED|95.0|-1.88|7.29||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis|||||7.29|-1.88|0.2453
73982462|NCT01263223|147510878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||<|0.0001|TWO_SIDED|95.0|3.37|6.82||P-value if for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis|||||6.82|3.37|<0.0001
73982463|NCT01263223|147510878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.53||||0.0005|TWO_SIDED|95.0|2.95|10.1||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis|||||10.1|2.95|0.0005
73982464|NCT01263223|147510879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|||<|0.0001|TWO_SIDED|95.0|8.7|16.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||16.9|8.7|<0.0001
73982465|NCT01263223|147510879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0||||0.0001|TWO_SIDED|95.0|11.4|34.5||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||34.5|11.4|0.0001
73982466|NCT01263223|147510880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.212|TWO_SIDED|95.0|-1.6|7.2||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis|||||7.2|-1.6|0.2120
73982467|NCT01263223|147510880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6||||0.064|TWO_SIDED|95.0|-0.4|15.5||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis|||||15.5|-0.4|0.0640
73982468|NCT01263223|147510880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.0211|TWO_SIDED|95.0|0.5|6.7||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis|||||6.7|0.5|0.0211
73982469|NCT01263223|147510880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.8719|TWO_SIDED|95.0|-5.7|6.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis|||||6.8|-5.7|0.8719
73982470|NCT01263223|147510881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.7133|TWO_SIDED|95.0|-5.3|3.7||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||3.7|-5.3|0.7133
73982471|NCT01263223|147510881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.4638|TWO_SIDED|95.0|-17.2|7.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||7.9|-17.2|0.4638
73982472|NCT01263223|147510882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||<|0.0001|TWO_SIDED|95.0|11.3|15.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||15.9|11.3|<0.0001
73982473|NCT01263223|147510882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.6|||<|0.0001|TWO_SIDED|95.0|21.1|34.2||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||34.2|21.1|<0.0001
73982474|NCT01263223|147510883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9609|TWO_SIDED|95.0|-4.9|4.7||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis|||||4.7|-4.9|0.9609
73982475|NCT01263223|147510883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.2731|TWO_SIDED|95.0|-3.9|13.6||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis|||||13.6|-3.9|0.2731
73982476|NCT01263223|147510883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.3779|TWO_SIDED|95.0|-4.8|1.8||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis|||||1.8|-4.8|0.3779
73982477|NCT01263223|147510883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.0828|TWO_SIDED|95.0|-12.8|0.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis|||||0.8|-12.8|0.0828
73982478|NCT02246647|147510884|OTHER||Mean Difference (Final Values)|0.01||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.87
73982479|NCT03557307|147510898|OTHER||percentage|62.9|||||TWO_SIDED|95.0|58.86|66.76|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieved 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||66.76|58.86|
73982480|NCT03557307|147510899|OTHER||percentage|81.9|||||TWO_SIDED|95.0|78.62|84.94|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieve 100% reduction or a daily OCS dose of \<=5mg, if reason for no further OCS reduction is Adrenal Insufficiency, that are sustained over at least 4 weeks without worsening of asthma|||84.94|78.62|
73982481|NCT03557307|147510900|OTHER||percentage|91.5|||||TWO_SIDED|95.0|88.94|93.58|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieve a daily OCS dose of ≤5 mg (regardless of reason for no further OCS reduction), that are sustained over at least 4 weeks without worsening of asthma|||93.58|88.94|
73982482|NCT03557307|147510901|OTHER||percentage|64.0|||||TWO_SIDED|95.0|60.06|67.9|||Clopper-Pearson Exact CI|One sample Confidence Interval (≥90% reduction)|Percentage of patients who achieve \>=90% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||67.90|60.06|
73982483|NCT03557307|147510901|OTHER||percentage|68.9|||||TWO_SIDED|95.0|65.02|72.59|||Clopper-Pearson Exact CI|One sample Confidence Interval (\>=75% reduction)|Percentage of patients who achieve \>=75% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||72.59|65.02|
73982484|NCT03557307|147510901|OTHER||percentage|81.8|||||TWO_SIDED|95.0|78.44|84.79|||Clopper-Pearson Exact CI|One sample Confidence Interval (\>=50% reduction)|Percentage of patients who achieve \>=50% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||84.79|78.44|
73982485|NCT03557307|147510902|OTHER||percentage change from baseline|-76.92|||||TWO_SIDED|95.0|-79.9|-73.94|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage change from baseline in daily OCS dose at the end of OCS reduction phase|||-73.94|-79.90|
73982486|NCT03184519|147510907|SUPERIORITY||Area Under Curve|0.79||||0.025|ONE_SIDED||||||t-test, 1 sided|||||||0.025
73982487|NCT03345407|147510910|OTHER||Posterior adjusted median difference|-0.022|||||TWO_SIDED|95.0|-0.143|0.103|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.103|-0.143|
73982488|NCT03345407|147510910|OTHER||Posterior adjusted median difference|-0.027|||||TWO_SIDED|95.0|-0.098|0.036|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.036|-0.098|
73982489|NCT03345407|147510910|OTHER||Posterior adjusted median difference|-0.038|||||TWO_SIDED|95.0|-0.102|0.028|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.028|-0.102|
73982490|NCT03345407|147510910|OTHER||Posterior adjusted median difference|0.005|||||TWO_SIDED|95.0|-0.064|0.071|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.071|-0.064|
73982491|NCT03345407|147510910|OTHER||Posterior adjusted median difference|-0.003|||||TWO_SIDED|95.0|-0.075|0.061|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.061|-0.075|
73982492|NCT03345407|147510910|OTHER||Posterior adjusted median difference|-0.004|||||TWO_SIDED|95.0|-0.051|0.042|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.042|-0.051|
74033764|NCT03345836|147620520|SUPERIORITY||Adjusted Treatment Difference|7.5|||<|0.0001|TWO_SIDED|95.0|5.2|9.8||P-value was calculated using mixed effect model repeat measurement (MMRM) with Baseline, treatment, visit, treatment by visit interaction and stratification factors in the model.|MMRM||Point estimate and 95% CI was calculated using MMRM.|||9.8|5.2|< 0.0001
73982493|NCT03345407|147510911|OTHER||Posterior median exacerbation rate ratio|0.92|||||TWO_SIDED|95.0|0.6|1.4|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for moderate/severe exacerbations has been presented.|||1.40|0.60|
74033765|NCT03345836|147620521|SUPERIORITY||Adjusted Treatment Difference|24.3|||<|0.0001|TWO_SIDED|95.0|17.2|31.5||P-value was calculated using MMRM with Baseline, treatment, visit, treatment by visit interaction and stratification factors in the model.|MMRM||Point estimate and 95% CI was calculated using MMRM.|||31.5|17.2|< 0.0001
73982494|NCT03345407|147510911|OTHER||Posterior median exacerbation rate ratio|0.89|||||TWO_SIDED|95.0|0.57|1.35|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for moderate/severe exacerbations has been presented.|||1.35|0.57|
73982495|NCT03345407|147510911|OTHER||Posterior median exacerbation rate ratio|1.01|||||TWO_SIDED|95.0|0.65|1.5|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for moderate/severe exacerbations has been presented.|||1.50|0.65|
73982496|NCT03345407|147510911|OTHER||Posterior median exacerbation rate ratio|0.63|||||TWO_SIDED|95.0|0.37|1.02|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for moderate/severe exacerbations has been presented.|||1.02|0.37|
73982497|NCT03345407|147510911|OTHER||Posterior median exacerbation rate ratio|1.13|||||TWO_SIDED|95.0|0.85|1.52|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for moderate/severe exacerbations has been presented.|||1.52|0.85|
73982498|NCT03345407|147510912|OTHER||Posterior median hazard ratio|0.455|||||TWO_SIDED|95.0|0.054|1.103|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.103|0.054|
73982499|NCT03345407|147510912|OTHER||Posterior median hazard ratio|0.991|||||TWO_SIDED|95.0|0.58|1.5|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.500|0.580|
73982500|NCT03345407|147510912|OTHER||Posterior median hazard ratio|0.975|||||TWO_SIDED|95.0|0.581|1.467|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.467|0.581|
73982501|NCT03345407|147510912|OTHER||Posterior median hazard ratio|1.132|||||TWO_SIDED|95.0|0.682|1.709|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.709|0.682|
73982502|NCT03345407|147510912|OTHER||Posterior median hazard ratio|0.556|||||TWO_SIDED|95.0|0.268|0.902|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||0.902|0.268|
73982503|NCT03345407|147510912|OTHER||Posterior median hazard ratio|1.149|||||TWO_SIDED|95.0|0.8|1.539|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.539|0.800|
73982504|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.01|||||TWO_SIDED|95.0|0.21|2.3|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.30|0.21|
73982505|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.37|||||TWO_SIDED|95.0|0.76|2.17|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.76|
73982506|NCT03345407|147510915|OTHER||Posterior median odds ratio|0.99|||||TWO_SIDED|95.0|0.54|1.61|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.61|0.54|
73982507|NCT03345407|147510915|OTHER||Posterior median odds ratio|0.94|||||TWO_SIDED|95.0|0.5|1.49|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.49|0.50|
73982508|NCT03345407|147510915|OTHER||Posterior median odds ratio|0.75|||||TWO_SIDED|95.0|0.38|1.25|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.25|0.38|
73982509|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.77|1.63|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.63|0.77|
73982510|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.21|||||TWO_SIDED|95.0|0.36|2.69|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.69|0.36|
73982511|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.82|2.33|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.33|0.82|
73982512|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.67|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.79|0.67|
73982513|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.12|||||TWO_SIDED|95.0|0.63|1.74|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.74|0.63|
73982514|NCT03345407|147510915|OTHER||Posterior median odds ratio|0.55|||||TWO_SIDED|95.0|0.28|0.88|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.88|0.28|
73982515|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.72|1.49|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.49|0.72|
73982516|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.0|||||TWO_SIDED|95.0|0.3|2.17|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.30|
74033766|NCT03345836|147620522|SUPERIORITY||Adjusted Treatment Difference|20.7|||<|0.0001|TWO_SIDED|95.0|13.7|27.8||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||27.8|13.7|<0.0001
73982517|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.46|||||TWO_SIDED|95.0|0.84|2.27|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.27|0.84|
73982518|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.15|||||TWO_SIDED|95.0|0.65|1.78|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.78|0.65|
73982519|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.09|||||TWO_SIDED|95.0|0.62|1.67|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.67|0.62|
73982520|NCT03345407|147510915|OTHER||Posterior median odds ratio|0.49|||||TWO_SIDED|95.0|0.26|0.77|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.77|0.26|
73982521|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.04|||||TWO_SIDED|95.0|0.71|1.42|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.42|0.71|
73982522|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.32|2.38|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.38|0.32|
73982523|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.29|||||TWO_SIDED|95.0|0.7|2.0|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.00|0.70|
73982524|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.12|||||TWO_SIDED|95.0|0.63|1.71|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.71|0.63|
73982525|NCT03345407|147510915|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.55|1.48|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.48|0.55|
73982526|NCT03345407|147510915|OTHER||Posterior median odds ratio|0.56|||||TWO_SIDED|95.0|0.31|0.87|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.87|0.31|
73982527|NCT03345407|147510915|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.73|1.47|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.47|0.73|
73982528|NCT03345407|147510916|OTHER||Posterior median hazard ratio|1.053|||||TWO_SIDED|95.0|0.477|1.765|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.765|0.477|
73982529|NCT03345407|147510916|OTHER||Posterior median hazard ratio|1.2|||||TWO_SIDED|95.0|0.84|1.597|||||Treatment comparison between placebo and Nemiralisib 50 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.597|0.840|
73982530|NCT03345407|147510916|OTHER||Posterior median hazard ratio|1.06|||||TWO_SIDED|95.0|0.734|1.432|||||Treatment comparison between placebo and Nemiralisib 100 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.432|0.734|
73982531|NCT03345407|147510916|OTHER||Posterior median hazard ratio|1.03|||||TWO_SIDED|95.0|0.719|1.413|||||Treatment comparison between placebo and Nemiralisib 250 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.413|0.719|
73982532|NCT03345407|147510916|OTHER||Posterior median hazard ratio|0.751|||||TWO_SIDED|95.0|0.487|1.057|||||Treatment comparison between placebo and Nemiralisib 500 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.057|0.487|
73982533|NCT03345407|147510916|OTHER||Posterior median hazard ratio|1.149|||||TWO_SIDED|95.0|0.899|1.426|||||Treatment comparison between placebo and Nemiralisib 750 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.426|0.899|
73982534|NCT03345407|147510918|OTHER||Posterior median odds ratio|1.22|||||TWO_SIDED|95.0|0.35|2.7|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.70|0.35|
73982535|NCT03345407|147510918|OTHER||Posterior median odds ratio|1.11|||||TWO_SIDED|95.0|0.63|1.77|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.77|0.63|
73982536|NCT03345407|147510918|OTHER||Posterior median odds ratio|1.41|||||TWO_SIDED|95.0|0.77|2.17|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.77|
73982537|NCT03345407|147510918|OTHER||Posterior median odds ratio|1.28|||||TWO_SIDED|95.0|0.71|2.0|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.00|0.71|
73982538|NCT03345407|147510918|OTHER||Posterior median odds ratio|1.11|||||TWO_SIDED|95.0|0.61|1.75|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.75|0.61|
73982539|NCT03345407|147510918|OTHER||Posterior median odds ratio|0.7|||||TWO_SIDED|95.0|0.46|0.99|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.99|0.46|
73982540|NCT03345407|147510918|OTHER||Posterior median odds ratio|0.64|||||TWO_SIDED|95.0|0.2|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.41|0.20|
73982541|NCT03345407|147510918|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.84|2.46|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.46|0.84|
73982542|NCT03345407|147510918|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.53|1.48|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.48|0.53|
74033767|NCT03345836|147620523|SUPERIORITY||Adjusted Treatment Difference|22.8|||<|0.0001|TWO_SIDED|95.0|14.4|31.2||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||31.2|14.4|<0.0001
74033768|NCT03345836|147620524|SUPERIORITY||Adjusted Treatment Difference|12.1||||0.0013|TWO_SIDED|95.0|4.7|19.5||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||19.5|4.7|0.0013
73982543|NCT03345407|147510918|OTHER||Posterior median odds ratio|1.36|||||TWO_SIDED|95.0|0.74|2.16|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.16|0.74|
73982544|NCT03345407|147510918|OTHER||Posterior median odds ratio|0.76|||||TWO_SIDED|95.0|0.43|1.17|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.17|0.43|
73982545|NCT03345407|147510918|OTHER||Posterior median odds ratio|0.93|||||TWO_SIDED|95.0|0.63|1.27|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.27|0.63|
73982546|NCT03345407|147510918|OTHER||Posterior median odds ratio|0.54|||||TWO_SIDED|95.0|0.16|1.2|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.20|0.16|
73982547|NCT03345407|147510918|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.79|2.56|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.56|0.79|
73982548|NCT03345407|147510918|OTHER||Posterior median odds ratio|0.83|||||TWO_SIDED|95.0|0.46|1.3|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.30|0.46|
73982549|NCT03345407|147510918|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.62|1.86|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.86|0.62|
73982550|NCT03345407|147510918|OTHER||Posterior median odds ratio|0.65|||||TWO_SIDED|95.0|0.36|1.02|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.02|0.36|
73982551|NCT03345407|147510918|OTHER||Posterior median odds ratio|0.85|||||TWO_SIDED|95.0|0.57|1.17|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.17|0.57|
73982552|NCT03345407|147510919|OTHER||Posterior adjusted median difference|2.4|||||TWO_SIDED|95.0|-0.5|5.2|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.2|-0.5|
73982553|NCT03345407|147510919|OTHER||Posterior adjusted median difference|0.7|||||TWO_SIDED|95.0|-0.8|2.3|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-0.8|
73982554|NCT03345407|147510919|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.8|2.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.4|-0.8|
73982555|NCT03345407|147510919|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-2.0|1.2|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.2|-2.0|
73982556|NCT03345407|147510919|OTHER||Posterior adjacent median difference|1.6|||||TWO_SIDED|95.0|0.0|3.3|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.3|0.0|
73982557|NCT03345407|147510919|OTHER||Posterior adjusted median difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-1.1|
73982558|NCT03345407|147510919|OTHER||Posterior adjusted median difference|2.3|||||TWO_SIDED|95.0|-0.5|5.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.4|-0.5|
73982559|NCT03345407|147510919|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.9|2.4|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.4|-0.9|
73982560|NCT03345407|147510919|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-1.9|1.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.4|-1.9|
73982561|NCT03345407|147510919|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.0|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.0|-2.3|
73982562|NCT03345407|147510919|OTHER||Posterior adjusted median difference|0.4|||||TWO_SIDED|95.0|-1.2|2.2|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.2|-1.2|
73982563|NCT03345407|147510919|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-1.4|1.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.0|-1.4|
73982564|NCT03345407|147510919|OTHER||Posterior adjusted median difference|1.9|||||TWO_SIDED|95.0|-1.4|5.1|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.1|-1.4|
74033769|NCT03345836|147620525|SUPERIORITY||Treatment Difference|-2.6||||0.2834|TWO_SIDED|95.0|-7.6|2.4||P-value was calculated using Chi-squared test.|Chi-squared||Point estimate and 95% CI was calculated using Chi-squared test.|||2.4|-7.6|0.2834
73982565|NCT03345407|147510919|OTHER||Posterior adjusted median difference|1.1|||||TWO_SIDED|95.0|-0.7|2.8|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.8|-0.7|
73982566|NCT03345407|147510919|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjsted median difference and 95% HPD CrI has been presented.|||1.1|-2.3|
73982567|NCT03345407|147510919|OTHER||Posterior adjusted median difference|-0.1|||||TWO_SIDED|95.0|-1.9|1.7|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.7|-1.9|
73982568|NCT03345407|147510919|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.9|2.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.8|-0.9|
73982569|NCT03345407|147510919|OTHER||Posterior adjusted median difference|0.4|||||TWO_SIDED|95.0|-0.8|1.7|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.7|-0.8|
73982570|NCT03345407|147510920|OTHER||Posterior median odds ratio|0.51|||||TWO_SIDED|95.0|0.03|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.41|0.03|
73982571|NCT03345407|147510920|OTHER||Posterior median odds ratio|0.87|||||TWO_SIDED|95.0|0.42|1.47|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.47|0.42|
73982572|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.37|||||TWO_SIDED|95.0|0.69|2.24|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.24|0.69|
73982573|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.78|||||TWO_SIDED|95.0|0.95|2.91|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.91|0.95|
73982574|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.24|||||TWO_SIDED|95.0|0.61|2.08|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.08|0.61|
73982575|NCT03345407|147510920|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.6|1.4|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.40|0.60|
73982576|NCT03345407|147510920|OTHER||Posterior median odds ratio|0.54|||||TWO_SIDED|95.0|0.14|1.16|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.16|0.14|
73982577|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.27|||||TWO_SIDED|95.0|0.74|1.98|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.98|0.74|
73982578|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.29|||||TWO_SIDED|95.0|0.73|1.97|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.97|0.73|
74033770|NCT03345836|147620526|SUPERIORITY||Adjusted Treatment Difference|11.5||||0.0833|TWO_SIDED|95.0|-1.5|24.4||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||24.4|-1.5|0.0833
74033771|NCT01943864|147620527|SUPERIORITY_OR_OTHER||non PD rate at Week 12|10.0||||0.976|TWO_SIDED|95.0|1.2|31.7|||Exact Binomial Test|||||31.7|1.2|0.976
74033772|NCT01943864|147620528|SUPERIORITY_OR_OTHER||non PD rate at Week 12|15.0||||0.909|TWO_SIDED|95.0|3.2|37.9|||Exact Binomial Test|||||37.9|3.2|0.909
73982579|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.47|||||TWO_SIDED|95.0|0.83|2.27|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.27|0.83|
73982580|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.04|||||TWO_SIDED|95.0|0.57|1.62|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.62|0.57|
73982581|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.1|||||TWO_SIDED|95.0|0.75|1.5|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.50|0.75|
73982582|NCT03345407|147510920|OTHER||Posterior median odds ratio|0.63|||||TWO_SIDED|95.0|0.17|1.39|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.39|0.17|
73982583|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.27|||||TWO_SIDED|95.0|0.72|2.01|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.01|0.72|
73982584|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.13|||||TWO_SIDED|95.0|0.64|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.79|0.64|
73982585|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.35|||||TWO_SIDED|95.0|0.75|2.14|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.14|0.75|
73982586|NCT03345407|147510920|OTHER||Posterior median odds ratio|0.94|||||TWO_SIDED|95.0|0.53|1.45|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.45|0.53|
74033773|NCT01943864|147620543|SUPERIORITY_OR_OTHER||Median PFS|10.6|||||TWO_SIDED|95.0|4.6|12.1|||||Lower and upper limits and estimation value are in terms of weeks|||12.1|4.6|
74033774|NCT01943864|147620544|SUPERIORITY_OR_OTHER||Median PFS|10.6|||||TWO_SIDED|95.0|4.6|12.7|||||Lower and upper limits and estimation value are in terms of weeks|||12.7|4.6|
74033775|NCT01943864|147620545|SUPERIORITY_OR_OTHER||Overall Survival|20.0|||||TWO_SIDED|95.0|6.2|39.3||||||||39.3|6.2|
73956034|NCT00991276|147447809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.87|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-9.81|-5.93||This analysis was step 5 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-5.93|-9.81|<0.0001
73982587|NCT03345407|147510920|OTHER||Posterior median odds ratio|1.03|||||TWO_SIDED|95.0|0.71|1.43|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.43|0.71|
73982588|NCT03345407|147510921|OTHER||Posterior adjusted median difference|2.0|||||TWO_SIDED|95.0|-4.8|8.3|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||8.3|-4.8|
74033776|NCT01943864|147620546|SUPERIORITY_OR_OTHER||ORR|0.0|||||TWO_SIDED|95.0|0.0|16.8||||||||16.8|0|
74033777|NCT01943864|147620547|SUPERIORITY_OR_OTHER||ORR|5.0|||||TWO_SIDED|95.0|0.1|24.9||||||||24.9|0.1|
73982589|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-4.0|3.1|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.1|-4.0|
73982590|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-2.9|||||TWO_SIDED|95.0|-6.2|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-6.2|
73982591|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-3.2|||||TWO_SIDED|95.0|-6.7|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||0.4|-6.7|
73982592|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-0.1|||||TWO_SIDED|95.0|-4.0|3.5|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.5|-4.0|
73982593|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-2.7|2.3|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-2.7|
73982594|NCT03345407|147510921|OTHER||Posterior adjusted median difference|4.1|||||TWO_SIDED|95.0|-2.5|11.0|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||11.0|-2.5|
73982595|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-1.2|||||TWO_SIDED|95.0|-4.8|2.5|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.5|-4.8|
73982596|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-2.7|||||TWO_SIDED|95.0|-6.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-6.3|
74033778|NCT01156597|147620556|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|The percent change of HDL and triglycerides from baseline between groups was evaluated by ANOVA using baseline, 12 week and 24 week values||||||0.05
74033779|NCT00401622|147620561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.56|STANDARD_ERROR_OF_MEAN|7.51||0.31|TWO_SIDED|95.0|-7.24|22.36|||t-test, 2 sided|||||22.36|-7.24|0.31
74033780|NCT00401622|147620562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.11||0.45|TWO_SIDED|95.0|-0.38|0.04|||ANCOVA|Visit 1 A1c measurement used as the covariate||Change in A1C from baseline to week 52 between the OneTouch® Ultra®2 and control BGMS||0.04|-0.38|0.45
73874103|NCT01818596|147290230|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is \< 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|98.94|||||TWO_SIDED|90.0|93.71|104.46|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 2, 4, or 8 visit and presented as a geometric least squares mean (GLSM) ratio with 90% confidence interval (CI). Postbaseline value and baseline value were used as test and reference, respectively.||104.46|93.71|
73874104|NCT01818596|147290230|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is \< 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|102.66|||||TWO_SIDED|90.0|97.11|108.53|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 24 visit and presented as a GLSM ratio with 90% CI. Week 24 value and baseline value were used as test and reference, respectively.||108.53|97.11|
73956035|NCT00991276|147447809|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.97|<|0.0001|TWO_SIDED|95.0|3.27|7.12||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||7.12|3.27|<0.0001
73956036|NCT00991276|147447810|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.35|STANDARD_ERROR_OF_MEAN|2.57||0.0396|TWO_SIDED|95.0|-10.44|-0.26||This analysis was step 6 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.26|-10.44|0.0396
73956037|NCT00991276|147447810|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|2.55||0.0568|TWO_SIDED|95.0|-9.95|0.14||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.14|-9.95|0.0568
73956038|NCT00991276|147447810|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|2.52||0.8589|TWO_SIDED|95.0|-5.44|4.54||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.54|-5.44|0.8589
73956039|NCT00991276|147447811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|2.91|<|0.0001|TWO_SIDED|95.0|-20.26|-8.74||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.74|-20.26|<0.0001
73956040|NCT00991276|147447811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.35|STANDARD_ERROR_OF_MEAN|2.88||0.0001|TWO_SIDED|95.0|5.65|17.04||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||17.04|5.65|0.0001
73956041|NCT00991276|147447811|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.84|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|95.0|-31.51|-20.17||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-20.17|-31.51|<0.0001
73982597|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-3.3|||||TWO_SIDED|95.0|-7.3|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||0.4|-7.3|
73982598|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-0.8|||||TWO_SIDED|95.0|-4.6|3.0|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.0|-4.6|
73982599|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-0.4|||||TWO_SIDED|95.0|-2.9|2.5|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.5|-2.9|
73982600|NCT03345407|147510921|OTHER||Posterior adjusted median difference|2.4|||||TWO_SIDED|95.0|-4.8|9.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||9.4|-4.8|
73982601|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-4.1|3.6|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.6|-4.1|
73982602|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-2.3|||||TWO_SIDED|95.0|-6.1|1.8|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.8|-6.1|
73982603|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-1.8|||||TWO_SIDED|95.0|-5.7|2.3|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-5.7|
73982604|NCT03345407|147510921|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-4.5|3.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.8|-4.5|
73874105|NCT03801174|147290250|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.92||0.804|TWO_SIDED|95.0|-2.0|1.6|||Mixed Models Analysis|||||1.6|-2.0|.804
73956042|NCT00991276|147447812|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.53|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-20.84|-8.22||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.22|-20.84|<0.0001
73982605|NCT03345407|147510921|OTHER||Posterior adjusted median difference|1.2|||||TWO_SIDED|95.0|-1.7|4.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||4.0|-1.7|
73874106|NCT03801174|147290251|SUPERIORITY||Mean Difference (Net)|50.2|STANDARD_ERROR_OF_MEAN|93.0||0.59|TWO_SIDED|95.0|-132.0|233.0|||Mixed Models Analysis|||||233|-132|.590
73874107|NCT03801174|147290252|SUPERIORITY||Mean Difference (Net)|806.0|STANDARD_ERROR_OF_MEAN|443.0||0.069|TWO_SIDED|95.0|-64.0|1675.0|||Mixed Models Analysis|||||1675|-64|.069
73956043|NCT00991276|147447812|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|14.42|STANDARD_ERROR_OF_MEAN|3.15|<|0.0001|TWO_SIDED|95.0|8.18|20.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||20.67|8.18|<0.0001
73956044|NCT00991276|147447812|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.95|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001|TWO_SIDED|95.0|-35.16|-22.74||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-22.74|-35.16|<0.0001
73956045|NCT00991276|147447813|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.86|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.93|-1.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.80|-3.93|<0.0001
73956046|NCT00991276|147447813|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.71|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-5.76|-3.65||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.65|-5.76|<0.0001
73956047|NCT00991276|147447813|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.84|STANDARD_ERROR_OF_MEAN|0.53||0.0007|TWO_SIDED|95.0|0.79|2.89||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.89|0.79|0.0007
73982606|NCT04791917|147510956|SUPERIORITY|||||||0.26|||||||ANCOVA|F(1,41) = 1.32, partial eta squared = .03||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on breakpoint for alcohol including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.26
73982607|NCT04791917|147510957|SUPERIORITY|||||||0.11|||||||ANCOVA|F(1,43) = 2.60, partial eta squared = .06||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for alcohol including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.11
73982608|NCT04791917|147510958|SUPERIORITY|||||||0.17|||||||ANCOVA|F(1,42) = 1.95, partial eta squared = .04||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on alcohol Pmax including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.17
73982609|NCT04791917|147510959|SUPERIORITY|||||||0.91|||||||ANCOVA|F(1,43)=.01, partial eta squared = .00||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on alcohol essential value including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.91
73982610|NCT04791917|147510960|SUPERIORITY|||||||0.14|||||||ANCOVA|F(1,41) = 2.24, partial eta squared = .05||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on intensity of cannabis demand including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.14
73874108|NCT04502290|147290277|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the number of blocks after intervention will be not statistically significant.||||.04
73874109|NCT04502290|147290278|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the motor evoked potnetial after intervention will be not statistically significant.||||.02
73982611|NCT04791917|147510961|SUPERIORITY|||||||0.83|||||||ANCOVA|F(1,41) = .04, partial eta squared = .001||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on breakpoint of cannabis demand including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.83
73982612|NCT04791917|147510962|SUPERIORITY|||||||0.15|||||||ANCOVA|F(1,41) = 2.20, partial eta squared = .05||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.15
73982613|NCT04791917|147510963|SUPERIORITY|||||||0.24|||||||ANCOVA|F(1,41) = 1.41, partial eta squared = .03||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.24
73982614|NCT04791917|147510964|SUPERIORITY|||||||0.97|||||||ANCOVA|F(1,41) = .001, partial eta squared = .00||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Essential Value for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.97
73982615|NCT04791917|147510964|SUPERIORITY|||||||0.03|||||||ANCOVA|F(1,41) = 4.86, partial eta squared = .11||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Essential Value for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Time X Group interaction.||||.03
73982616|NCT04791917|147510965|SUPERIORITY|||||||0.04|||||||ANCOVA|F(1,42) = 4.66, partial eta squared = .10||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.04
73982617|NCT04791917|147510965|SUPERIORITY||Slope|0.1||||0.26|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the DOMS group.||||.26
74033781|NCT00520676|147620563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6||The comparison was conducted at a 1-sided significance level of 0.05.|Log Rank|Note that the 2-sided p-value for log rank is reported, which is \<0.001, hence 1-sided p-value is \<0.001.|Cox regression model is used for HR estimate.|||0.60|0.34|<0.001
73874110|NCT04502290|147290279|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the force after intervention will be not statistically significant.||||.04
73874111|NCT02326064|147290297|SUPERIORITY||||||<|0.001|||||||Mac-Nemar paired Chi-2 test|||||||<0.001
73874112|NCT02326064|147290298|SUPERIORITY||||||<|0.001|||||||Mac-Nemar paired Chi-2 test|||||||<0.001
73874113|NCT04317040|147290303|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|1.398||||0.0367|TWO_SIDED|95.0|1.02|1.918|||Log Rank||Cox-Regression Model|||1.918|1.020|0.0367
73874114|NCT04317040|147290305|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|-0.0555||||0.3281|TWO_SIDED|95.0|-0.1665|0.0555|||Chi-squared||Mantel-Haenszel method|||0.0555|-0.1665|0.3281
73874115|NCT04317040|147290306|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.558||||0.0306|TWO_SIDED|95.0|0.327|0.954|||Log Rank||Cox Regression Model|||0.954|0.327|0.0306
73982618|NCT04791917|147510965|SUPERIORITY||Slope|-0.09||||0.22|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the DOMS group.||||.22
73982619|NCT04791917|147510965|SUPERIORITY||Slope|-0.1||||0.27|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the sham DOMS group.||||.27
73982620|NCT04791917|147510965|SUPERIORITY||Slope|0.06||||0.49|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the sham DOMS group.||||.49
73982621|NCT01989156|147510966|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|12.58|||<|0.001|TWO_SIDED|95.0|9.27|17.05||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS Mean Ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarkers of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||17.05|9.27|<0.001
73982622|NCT01989156|147510967|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|45.77|||<|0.001|TWO_SIDED|95.0|39.22|53.41||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||53.41|39.22|<0.001
73982623|NCT01989156|147510968|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|12.58|||<|0.001|TWO_SIDED|95.0|9.54|16.58||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||16.58|9.54|<0.001
73982624|NCT01989156|147510969|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|26.41|||<|0.001|TWO_SIDED|95.0|17.31|40.26||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||40.26|17.31|<0.001
73982625|NCT01989156|147510970|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|38.14|||<|0.001|TWO_SIDED|95.0|34.24|42.47||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||42.47|34.24|<0.001
73982626|NCT02790788|147510971|SUPERIORITY||Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|4.3||0.44|TWO_SIDED|95.0|-5.2|11.8|||t-test, 2 sided|||Independent Samples t-test||11.8|-5.2|0.44
73982627|NCT02790788|147510973|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.6||0.17|TWO_SIDED|95.0|-2.2|12.2|||t-test, 2 sided|||||12.2|-2.2|0.17
73982628|NCT02790788|147510974|SUPERIORITY||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|5.0||0.043|TWO_SIDED|95.0|0.4|20.8|||t-test, 2 sided|||||20.8|0.4|0.043
73982629|NCT02790788|147510975|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|3.7||0.59|TWO_SIDED|95.0|-9.3|5.3|||t-test, 2 sided|||||5.3|-9.3|0.59
73982630|NCT02790788|147510976|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.0||0.64|TWO_SIDED|95.0|-3.1|5.0|||t-test, 2 sided|||||5.0|-3.1|0.64
73982631|NCT02790788|147510977|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|3.0||0.2|TWO_SIDED|95.0|-10.1|2.1|||t-test, 2 sided|||||2.1|-10.1|0.20
73982632|NCT02790788|147510978|SUPERIORITY||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|1.9||0.14|TWO_SIDED|95.0|-0.9|6.6|||t-test, 2 sided|||||6.6|-0.9|0.14
73982633|NCT02790788|147510979|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|3.4||0.9|TWO_SIDED|95.0|-6.4|7.3|||t-test, 2 sided|||||7.3|-6.4|0.90
73982634|NCT02790788|147510980|SUPERIORITY||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|2.2||0.33|TWO_SIDED|95.0|-2.2|6.4|||t-test, 2 sided|||||6.4|-2.2|0.33
73982635|NCT02790788|147510981|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|2.8||0.92|TWO_SIDED|95.0|-5.3|5.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA WITHIN 12 HOURS AFTER ROSC||5.8|-5.3|0.92
74033782|NCT00520676|147620564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.934|TWO_SIDED|95.0|0.72|1.42||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.|||1.42|0.72|0.934
74033783|NCT00520676|147620565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.8|TWO_SIDED|95.0|0.72|1.29||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank|Cox regression model is used for hazard ratio (HR) estimate.||||1.29|0.72|0.800
73982636|NCT02790788|147510981|SUPERIORITY||Mean Difference (Net)|-0.81|STANDARD_ERROR_OF_MEAN|1.3||0.54|TWO_SIDED|95.0|-3.4|1.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA WITHIN 12 HOURS AFTER ROSC||1.8|-3.4|0.54
73982637|NCT02790788|147510981|SUPERIORITY||Mean Difference (Net)|4.6|STANDARD_ERROR_OF_MEAN|2.17||0.048|TWO_SIDED|95.0|0.04|9.15|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA AT 72 HOURS AFTER ROSC||9.15|0.04|0.048
73982638|NCT02790788|147510981|SUPERIORITY||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.4||0.18|TWO_SIDED|95.0|-1.0|4.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA AT 72 HOURS AFTER ROSC||4.7|-1.0|0.18
73982639|NCT02790788|147510982|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|3.6||0.32|TWO_SIDED|95.0|-10.9|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF WITHIN 12 HOURS AFTER ROSC||3.7|-10.9|0.32
73874116|NCT04317040|147290307|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|0.027||||0.4491|TWO_SIDED|95.0|-0.043|0.097|||Chi-squared||Mantel-Haenszel method used to report all-cause mortality by Day 15|Day 15||0.0970|-0.0430|0.4491
73982640|NCT02790788|147510982|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|3.1||0.76|TWO_SIDED|95.0|-7.2|5.3|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 12 HOURS AFTER ROSC||5.3|-7.2|0.76
73982641|NCT02790788|147510982|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_ERROR_OF_MEAN|4.2||0.25|TWO_SIDED|95.0|-13.5|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF AT 72 HOURS AFTER ROSC||3.7|-13.5|0.25
73982642|NCT02790788|147510982|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|3.5||0.61|TWO_SIDED|95.0|-9.1|5.5|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 72 HOURS AFTER ROSC||5.5|-9.1|0.61
73982643|NCT02790788|147510983|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED|95.0|-0.25|0.11|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI WITHIN 12 HOURS OF ROSC.||0.11|-0.25|0.41
73982644|NCT02790788|147510983|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.38|TWO_SIDED|95.0|-0.26|0.1|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI WITHIN 12 HOURS AFTER ROSC.||0.10|-0.26|0.38
73982645|NCT02790788|147510983|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.46|TWO_SIDED|95.0|-0.29|0.14|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI AT 72 HOURS AFTER ROSC.||0.14|-0.29|0.46
73982646|NCT02790788|147510983|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED|95.0|-0.33|0.12|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI AT 72 HOURS AFTER ROSC.||0.12|-0.33|0.34
73982647|NCT02790788|147510984|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.65||0.9|TWO_SIDED|95.0|-1.5|1.3|||t-test, 2 sided|||||1.3|-1.5|0.90
73982648|NCT02790788|147510985|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.37||0.59|TWO_SIDED|95.0|-0.54|0.94|||t-test, 2 sided|||||0.94|-0.54|0.59
73982649|NCT02790788|147510986|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.38||0.67|TWO_SIDED|95.0|-0.6|0.93|||t-test, 2 sided|||||0.93|-0.60|0.67
73982650|NCT02790788|147510987|SUPERIORITY||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.65|TWO_SIDED|95.0|-0.64|1.02|||t-test, 2 sided|||||1.02|-0.64|0.65
73982651|NCT02790788|147510988|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.0||0.41|TWO_SIDED|95.0|-1.2|2.8||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 0-6 HOURS AFTER ROSC.|t-test, 2 sided|||||2.8|-1.2|0.41
73982652|NCT02790788|147510988|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.28||0.2|TWO_SIDED|95.0|-0.92|0.19|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.||0.19|-0.92|0.20
73982653|NCT02790788|147510988|SUPERIORITY||Median Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.26||0.07|TWO_SIDED|95.0|-1.0|0.04|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.||0.04|-1.00|0.07
73982654|NCT02790788|147510988|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.29||0.36|TWO_SIDED|95.0|-0.85|0.31|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 18-24 HOURS AFTER ROSC.||0.31|-0.85|0.36
73982655|NCT02790788|147510988|SUPERIORITY||Median Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.25||0.54|TWO_SIDED|95.0|-0.66|0.35|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 24-30 HOURS AFTER ROSC.||0.35|-0.66|0.54
73982656|NCT02790788|147510988|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.62|TWO_SIDED|95.0|-0.69|0.42|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 30-36 HOURS AFTER ROSC.||0.42|-0.69|0.62
73982657|NCT02790788|147510988|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|95.0|-0.71|0.41|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 36-42 HOURS AFTER ROSC.||0.41|-0.71|0.60
73982658|NCT02790788|147510988|SUPERIORITY||Median Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.26||0.54|TWO_SIDED|95.0|-0.69|0.36|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 42-48 HOURS AFTER ROSC.||0.36|-0.69|0.54
73982659|NCT02790788|147510989|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|0.87||0.42|TWO_SIDED|95.0|-2.5|1.1|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG||1.1|-2.5|0.42
73982660|NCT02790788|147510989|SUPERIORITY||Median Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|0.79||0.4|TWO_SIDED|95.0|-0.94|2.3|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 96.0 MMHG||2.30|-0.94|0.40
73982661|NCT02790788|147510989|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.15||0.44|TWO_SIDED|95.0|-1.49|3.28|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG||3.28|-1.49|0.44
73982662|NCT02790788|147510989|SUPERIORITY||Median Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|1.23||0.36|TWO_SIDED|95.0|-1.4|3.7|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 97.0 MMHG||3.70|-1.40|0.36
73982663|NCT02790788|147510990|SUPERIORITY|||||||0.84|||||||Mann Whitney|||||||0.84
73982664|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.144||0.86|TWO_SIDED|95.0|-0.311|0.262|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 4 HOURS AFTER ROSC||0.262|-0.311|0.86
73982665|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|-0.064|STANDARD_ERROR_OF_MEAN|0.111||0.56|TWO_SIDED|95.0|-0.287|0.158|||t-test, 2 sided|||RESULTS CORRESPOND TO TNF-α AT 4 HOURS AFTER ROSC||0.158|-0.287|0.56
73982666|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|0.034|STANDARD_ERROR_OF_MEAN|0.053||0.52|TWO_SIDED|95.0|-0.071|0.139|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 4 HOURS AFTER ROSC||0.139|-0.071|0.52
73982667|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|-0.041|STANDARD_ERROR_OF_MEAN|0.107||0.7|TWO_SIDED|95.0|-0.254|0.172|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 4 HOURS AFTER ROSC||0.172|-0.254|0.70
73982668|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.167||0.97|TWO_SIDED|95.0|-0.326|0.34|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 4 HOURS AFTER ROSC||0.340|-0.326|0.97
73982669|NCT02790788|147510991|SUPERIORITY||Median Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.129||0.61|TWO_SIDED|95.0|-0.192|0.326|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 24 HOURS AFTER ROSC||0.326|-0.192|0.61
73982670|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|0.014|STANDARD_ERROR_OF_MEAN|0.126||0.91|TWO_SIDED|95.0|-0.238|0.267|||t-test, 2 sided|||RESULTS CORRESPOND TO TNFα AT 24 HOURS AFTER ROSC||0.267|-0.238|0.91
73982671|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.19|TWO_SIDED|95.0|-0.1|0.021|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 24 HOURS AFTER ROSC||0.021|-0.100|0.19
73982672|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|-0.022|STANDARD_ERROR_OF_MEAN|0.111||0.85|TWO_SIDED|95.0|-0.244|0.201|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 24 HOURS AFTER ROSC||0.201|-0.244|0.85
73982673|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.162||0.37|TWO_SIDED|95.0|-0.179|0.473|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 24 HOURS AFTER ROSC||0.473|-0.179|0.37
74033784|NCT00520676|147620566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.081|TWO_SIDED|95.0|0.93|3.15||The comparison of tumor response rates was conducted at a 2-sided significance level of 0.05.|Fisher Exact|Tumor response rate= # participants with a confirmed best response of CR or PR / # of participants who qualify for the analysis population.|Logistic regression model is used for odds ratio (OR) estimate.|||3.15|0.93|0.081
74033785|NCT00520676|147620567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.641|TWO_SIDED|95.0|0.49|1.55||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.|||1.55|0.49|0.641
74033786|NCT00520676|147620568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.71||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.|||0.71|0.40|<0.001
74033787|NCT00520676|147620569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.35|0.66||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.|||0.66|0.35|<0.001
74033788|NCT00335504|147620596|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with atorvastatin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.30
73874117|NCT04317040|147290307|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|-0.0146||||0.7512|TWO_SIDED|95.0|-0.1049|0.0756|||Chi-squared||Mantel-Haenszel method used to report all-cause mortality by Day 29|Day 29||0.0756|-0.1049|0.7512
73982674|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.127||0.74|TWO_SIDED|95.0|-0.298|0.212|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 48 HOURS AFTER ROSC||0.212|-0.298|0.74
73982675|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|0.036|STANDARD_ERROR_OF_MEAN|0.14||0.8|TWO_SIDED|95.0|-0.246|0.318|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 48 HOURS AFTER ROSC||0.318|-0.246|0.80
73982676|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|0.056|STANDARD_ERROR_OF_MEAN|0.043||0.2|TWO_SIDED|95.0|-0.03|0.142|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 48 HOURS AFTER ROSC||0.142|-0.030|0.20
73982677|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|0.111||0.83|TWO_SIDED|95.0|-0.246|0.198|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 48 HOURS AFTER ROSC||0.198|-0.246|0.83
73982678|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.124||0.83|TWO_SIDED|95.0|-0.223|0.276|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 48 HOURS AFTER ROSC||0.276|-0.223|0.83
73982679|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.161||0.85|TWO_SIDED|95.0|-0.294|0.354|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 72 HOURS AFTER ROSC||0.354|-0.294|0.85
73982680|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|0.048|STANDARD_ERROR_OF_MEAN|0.145||0.74|TWO_SIDED|95.0|-0.243|0.339|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 72 HOURS AFTER ROSC||0.339|-0.243|0.74
73982681|NCT02790788|147510991|SUPERIORITY||Median Difference (Net)|0.013|STANDARD_ERROR_OF_MEAN|0.039||0.75|TWO_SIDED|95.0|-0.066|0.091|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 72 HOURS AFTER ROSC||0.091|-0.066|0.75
73982682|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.096||0.64|TWO_SIDED|95.0|-0.238|0.149|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 72 HOURS AFTER ROSC||0.149|-0.238|0.64
73982683|NCT02790788|147510991|SUPERIORITY||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.147||0.23|TWO_SIDED|95.0|-0.116|0.475|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 72 HOURS AFTER ROSC||0.475|-0.116|0.23
73982684|NCT02790788|147510992|SUPERIORITY||Percent Difference|4.9||||0.45|TWO_SIDED|95.0|-4.8|14.6|||Fisher Exact|||||14.6|-4.8|0.45
73982685|NCT02790788|147510993|SUPERIORITY||Mann-Whitney U|50903.5||||0.68|TWO_SIDED||||||Mann Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERGLYCEMIA||||0.68
74033789|NCT00335504|147620596|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with sulindac compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.60
73874118|NCT04317040|147290310|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|1.416||||0.0311|TWO_SIDED|95.0|1.031|1.945|||Log Rank||Cox Regression model|||1.945|1.031|0.0311
73982686|NCT02790788|147510993|SUPERIORITY||Mann Whitney U|52188.5||||0.68|TWO_SIDED||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERNATREMIA||||0.68
73982687|NCT02790788|147510993|SUPERIORITY||Mann-Whitney U|1128.5||||0.37|TWO_SIDED||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF INFECTION||||0.37
73982688|NCT00850993|147510994|OTHER|Pairwise comparison for each Stannsoporfin treatment group versus placebo.|LS Mean Difference|-13.45|||=|0.04|TWO_SIDED|95.0|-26.27|-0.62|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Least-squares means are from an ANCOVA model for adjusted TSB with treatment and gestational age as fixed effects and baseline adjusted TSB as a covariate. TSB is calculated as \[(TSB - Phototherapy(PT) threshold)/ PT threshold \] X 100%.||-0.62|-26.27|=0.040
73982689|NCT00850993|147510994|OTHER||LS Mean Difference|-10.02|||=|0.117|TWO_SIDED|95.0|-22.61|2.58|||ANCOVA|||||2.58|-22.61|=0.117
73982690|NCT00850993|147510994|OTHER||LS Mean Difference|-14.93|||=|0.057|TWO_SIDED|95.0|-30.31|0.44|||ANCOVA|||||0.44|-30.31|=0.057
73982691|NCT00850993|147510995|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.81|||=|0.061|TWO_SIDED|95.0|-3.71|0.09|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||0.09|-3.71|=0.061
73982692|NCT00850993|147510995|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.34|||=|0.163|TWO_SIDED|95.0|-3.24|0.56|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||0.56|-3.24|=0.163
73982693|NCT00850993|147510995|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-2.63|||=|0.028|TWO_SIDED|95.0|-4.97|-0.3|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||-0.3|-4.97|=0.028
73982694|NCT01426217|147511035|OTHER|Efficacy|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.63|0.98||||||||0.98|0.63|
73982695|NCT01426217|147511036|OTHER|Efficacy|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.62|1.35||||||||1.35|0.62|
74089634|NCT00754494|147732034|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.030
73874119|NCT01695135|147290338|SUPERIORITY||Hazard Ratio (HR)|0.528||||0.0002|TWO_SIDED|95.0|0.376|0.74|||Log Rank|||||0.740|0.376|0.0002
73982696|NCT02991456|147511066|OTHER|||||||0.2734|||||||Chi-squared|||||||0.2734
73982697|NCT02991456|147511067|OTHER|||||||0.7091|||||||Chi-squared|||||||0.7091
73982698|NCT02991456|147511068|EQUIVALENCE|This was tested as patients who preferred rolapitant + ondansetron vs. patients who did not prefer rolapitant + ondansetron. Patients who reported no preference and preference to Ondansetron were combined.||||||0.0004|||||||Exact Binomial|||||||0.0004
73982699|NCT02991456|147511068|EQUIVALENCE|Three outcomes tested by sequence.||||||0.5207|||||||Fisher Exact|||||||0.5207
73982700|NCT02991456|147511069|EQUIVALENCE|Effectiveness during weeks 1-3 between sequences.||||||0.0406|||||||t-test, 1 sided|T-test using the Satterthwaite method for unequal variances.||||||0.0406
73982701|NCT02991456|147511070|EQUIVALENCE|Convenience during weeks 1-3 between sequences.||||||0.0541|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.0541
73982702|NCT02991456|147511071|EQUIVALENCE|Overall satisfaction during weeks 1-3 between sequences.||||||0.0781|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.0781
73982703|NCT02991456|147511072|EQUIVALENCE|Effectiveness during weeks 4-6 between sequences.||||||0.4146|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.4146
73982704|NCT02991456|147511073|EQUIVALENCE|Convenience during weeks 4-6 between sequences.||||||0.2214|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.2214
73982705|NCT02991456|147511074|EQUIVALENCE|Overall satisfaction during weeks 4-6 between sequences.||||||0.2028|||||||t-test, 1 sided|T-test using the Satterthwaite method for unequal variances.||||||0.2028
74009199|NCT00397033|147569179|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.269||95.0|-1.9|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-1.9|0.269
74009200|NCT00397033|147569180|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.2|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.0|-3.2|<0.001
73982706|NCT04016415|147511084|SUPERIORITY|Two-sided tests with the null hypothesis of no difference in chg from Baseline to 6MO between the two arms. The power calculation assumed a clinically meaningful diff of 0.5% and standard deviation of 0.9%. Assuming an avg class cohort size of 18 pts and an intraclass correlation coefficient estimate of 0.08 for correlation within cohorts yielded a design effect that inflated the sample size by 1+((18-1) multiplied by 0.08)=2.36. A 15% dropout rate was assumed. 145 pts per arm yielded 80% power.|Mean Difference (Net)|-0.01||||0.96|TWO_SIDED|95.0|-0.36|0.34||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.34|-0.36|0.96
73982707|NCT04016415|147511085|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|-0.07||||0.68|TWO_SIDED|95.0|-0.38|0.25||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.25|-0.38|0.68
73982708|NCT04016415|147511086|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|0.06||||0.41|TWO_SIDED|95.0|-0.09|0.21||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.21|-0.09|0.41
73982709|NCT04016415|147511087|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 6MO between the two arms.|Mean Difference (Net)|-0.05||||0.59|TWO_SIDED|95.0|-0.22|0.12||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.12|-0.22|0.59
73982710|NCT04016415|147511088|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|1.57||||0.04|TWO_SIDED|95.0|0.07|3.06||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||3.06|0.07|0.04
73982711|NCT04016415|147511089|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 6MO between the two arms.|Mean Difference (Net)|0.83||||0.3|TWO_SIDED|95.0|-0.74|2.4||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||2.40|-0.74|0.30
73982712|NCT05615870|147511090|SUPERIORITY||Mean Difference (Final Values)|5.41||||0.537|TWO_SIDED|95.0|-11.77|22.6|||Mixed Models Analysis|||Null hypothesis: mean of SFDs in the HEPA filtration home intervention group will not differ from the mean of SFDs in the control group||22.60|-11.77|0.537
73982713|NCT05615870|147511091|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.205|TWO_SIDED|95.0|-0.07|0.3|||Mixed Models Analysis|||Null hypothesis: mean of counts of hospitalizations for respiratory symptoms in the intervention group will not differ from the mean of counts of hospitalizations for respiratory symptoms in the control group||0.30|-0.07|0.205
73982714|NCT05615870|147511091|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.35|0.35|||Mixed Models Analysis|||Null hypothesis: mean of counts of emergency department or urgent care visits for respiratory symptoms in the intervention group will not differ from the mean of counts of emergency department or urgent care visits for respiratory symptoms in the control group||0.35|-0.35|0.992
73982715|NCT05615870|147511091|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.172|TWO_SIDED|95.0|-0.9|0.16|||Mixed Models Analysis|||Null hypothesis: mean of counts of other unscheduled healthcare visits for respiratory symptoms in the intervention group will not differ from the mean of counts of other unscheduled healthcare visits for respiratory symptoms in the control group||0.16|-0.90|0.172
73982716|NCT05615870|147511091|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.53|TWO_SIDED|95.0|-1.02|0.52|||Mixed Models Analysis|||Null hypothesis: mean of counts (or total counts) of visits of all metrics for respiratory symptoms in the intervention group will not differ from the mean of counts of visits of all metrics for respiratory symptoms in the control group||0.52|-1.02|0.530
73982717|NCT05615870|147511092|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.598|TWO_SIDED|95.0|-3.75|2.16|||Mixed Models Analysis|||Null hypothesis: mean of the Child QOL score in the HEPA intervention group will not differ from the mean of Child QOL score in the control group||2.16|-3.75|0.598
73982718|NCT05615870|147511093|SUPERIORITY||Mean Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.98|-3.42|||Mixed Models Analysis||The results were based on the average PM2.5 level of common room and sleep space.|Null hypothesis: the mean of the PM2.5 level of the common room and sleep space in the intervention group will not differ from the mean of the PM2.5 level in the control group||-3.42|-10.98|<0.001
73982719|NCT02009865|147511112|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-14.2||||0.017|TWO_SIDED|95.0|-26.2|-2.8|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure|Missing values were imputed using probabilities of missing estimated from logistic regression||-2.8|-26.2|0.017
73982720|NCT02009865|147511113|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-26.3||||0.0008|TWO_SIDED|95.0|-40.5|-11.5|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Main analysis with missing values imputed using probabilities of missing estimated from logistic regression||-11.5|-40.5|0.0008
73982721|NCT02009865|147511114|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-9.0||||0.018|TWO_SIDED|95.0|-14.8|-2.8||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||-2.8|-14.8|0.0180
73982722|NCT02009865|147511115|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.3||||0.7117|TWO_SIDED|95.0|-3.5|4.9||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||4.9|-3.5|0.7117
73982723|NCT02009865|147511116|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.3||||0.3034|TWO_SIDED|95.0|-23.9|3.5||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||3.5|-23.9|0.3034
73982726|NCT04649359|147511166|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 30%.||||<0.0001
73982727|NCT04649359|147511166|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort B was 15%.||||<0.0001
73982728|NCT04649359|147511167|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 12%.||||<0.0001
73982729|NCT04649359|147511168|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 38%.||||<0.0001
73982730|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E Amygdala- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982731|NCT02069366|147511225|SUPERIORITY|||||||0.041||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E Hippocampus- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.041
73982732|NCT02069366|147511225|SUPERIORITY|||||||0.04||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E vmPFC- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U)||||0.040
73982733|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS- Amygdala- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982734|NCT02069366|147511225|SUPERIORITY|||||||0.041||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS- Hippocampus- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.041
73982735|NCT02069366|147511225|SUPERIORITY|||||||0.04||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus time factors.||This analysis corresponds to the row 'Extinction Learning CS- vmPFC- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.040
73982736|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E Amygdala- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982737|NCT02069366|147511225|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
73982738|NCT02069366|147511225|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
73982739|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982740|NCT02069366|147511225|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
73982741|NCT02069366|147511225|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
73982742|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982743|NCT02069366|147511225|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
73982744|NCT02069366|147511225|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
73982745|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982746|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E Hippocampus- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982747|NCT02069366|147511225|SUPERIORITY|||||||0.025||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E vmPFC- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.025
73982748|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- Amygdala- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982749|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982750|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982751|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982752|NCT02069366|147511225|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
73982753|NCT02069366|147511225|SUPERIORITY|||||||0.025||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.025
73982754|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+E Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982755|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+U Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982756|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS-Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982757|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+E Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982758|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+U Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982759|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS- Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982760|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS+E Early- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
74033790|NCT00335504|147620596|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with oligofructose-enriched inulin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.92
74033791|NCT00335504|147620596|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.59
74033792|NCT00335504|147620596|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.12
73982761|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS- Early- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982762|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS+E Late-Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982763|NCT02069366|147511226|SUPERIORITY|||||||0.04||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS- Late- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||0.04
73982764|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+E Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982765|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+U Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982766|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS- Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982767|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+E Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982768|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+U Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982769|NCT02069366|147511226|SUPERIORITY|||||||0.033||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS- Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||0.033
73982770|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+E Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982771|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+U Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982772|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS- Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982773|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+E Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982774|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+U Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
74033793|NCT00335504|147620596|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.54
74033794|NCT00335504|147620596|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.41
74033795|NCT00335504|147620597|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between atorvastatin and placebo.||||0.37
74033796|NCT00335504|147620597|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between sulindac and placebo.||||1.00
73982775|NCT02069366|147511226|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS- Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
73982776|NCT02069366|147511227|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Pre- Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
73982777|NCT02069366|147511227|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Mid-Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
73982778|NCT02069366|147511227|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Post-Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
73982779|NCT02069366|147511227|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Pre-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
73982780|NCT02069366|147511227|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Mid-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
73982781|NCT02069366|147511227|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Post-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
73982782|NCT02069366|147511227|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Pre-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
73982783|NCT02069366|147511227|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Mid-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
73982784|NCT02069366|147511227|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Post-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
74033797|NCT00335504|147620597|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between oligofructose-enriched inulin and placebo.||||0.58
73982785|NCT01951105|147511240|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74033798|NCT00335504|147620598|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between atorvastatin calcium and placebo.||||0.26
74033799|NCT00335504|147620598|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between sulindac and placebo.||||0.88
74033800|NCT00335504|147620598|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between oligofructose-enriched inulin and placebo.||||0.38
74033801|NCT00115349|147620628|SUPERIORITY_OR_OTHER|||||||0.89||0.0|||||Mixed Models Analysis|Linear mixed models with treatment, time, and treatment x time interaction were used, allowing for random participant-specific intercepts and slopes.||The intended sample size of 86 patients (N=43 per arm) had 80% power to detect a 5% difference in LVEF between the two arms after 1 year of treatment, assuming a standard deviation of change in LVEF of 7.46%, and 20% loss to follow-up. The study was stopped early by NHLBI when analysis of the interim data confirmed a required sample size of 86 that was not achievable within the required time frame within the participating or planned centres.||||0.89
73982786|NCT02105688|147511250|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided exact test|||A one-sided exact test was used to test the null hypothesis, which was that the SVR12 rate for the ITA was less than 67% (historical reference rate derived from NCT01667731). The p-value was based on a one-sided exact test for a binomial proportion. A one-sided p-value \<0.025 supports a conclusion that the true SVR12 is \>67%.||||<0.001
73982787|NCT02105688|147511251|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-8.3|10.0||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.||10.0|-8.3|
73982788|NCT02105688|147511252|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-0.5|||||TWO_SIDED|95.0|-5.0|1.9||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.||1.9|-5.0|
73982789|NCT01601821|147511255|SUPERIORITY_OR_OTHER||percent difference|-2.0||||0.341|TWO_SIDED|90.0|-5.5|1.5|||Chi-squared|||Chi-square test was used to test superiority of arm CsA+Rapamune+CS versus arm CsA+MMF+CS.||1.5|-5.5|0.341
73982790|NCT01601821|147511256|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way analysis of variance (ANOVA) was used to test the difference.||||0.870
74033802|NCT01718509|147620640|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.66|||<|0.001|TWO_SIDED|95.0|-2.04|-1.28|||Mixed Models Repeated Measures Analysis|||||-1.28|-2.04|<0.001
74033803|NCT01718509|147620641|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||||||<0.001
74033804|NCT01718509|147620642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||||||<0.001
74033805|NCT01718509|147620643|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-5.41|||<|0.001|TWO_SIDED|95.0|-6.39|-4.44|||Mixed Models Repeated Measures Analysis|||||-4.44|-6.39|<0.001
74033806|NCT01718509|147620644|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-7.94|||<|0.001|TWO_SIDED|95.0|-9.51|-6.36|||Mixed Models Repeated Measures Analysis|||||-6.36|-9.51|<0.001
73982791|NCT01601821|147511256|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.381
73982792|NCT01601821|147511256|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.096
73982793|NCT01601821|147511257|SUPERIORITY_OR_OTHER|||||||0.979|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.||||0.979
73982794|NCT01601821|147511257|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.660
73982795|NCT01601821|147511257|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.518
73982796|NCT01601821|147511258|SUPERIORITY_OR_OTHER|||||||0.786|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.||||0.786
73982797|NCT01601821|147511258|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.738
73982798|NCT01601821|147511258|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.977
73982799|NCT01601821|147511259|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
73982800|NCT01601821|147511261|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.276
73982801|NCT01601821|147511262|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
73982802|NCT01601821|147511263|SUPERIORITY_OR_OTHER|||||||0.868|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.868
73982803|NCT01601821|147511264|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
73982804|NCT01601821|147511265|SUPERIORITY_OR_OTHER|||||||0.985|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.985
73982805|NCT01601821|147511266|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.172
73982806|NCT01601821|147511267|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.978
73982807|NCT02469155|147511268|SUPERIORITY||Least Squares Mean Difference|0.1||||0.972|TWO_SIDED|95.0|-3.39|3.51|||Mixed Models for Repeated Measure|||||3.51|-3.39|0.972
73982808|NCT02469155|147511268|SUPERIORITY||Least Squares Mean Difference|0.5||||0.789|TWO_SIDED|95.0|-2.92|3.84|||Mixed Effects Model for Repeated Measure|||||3.84|-2.92|0.789
73982809|NCT00442559|147511270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16||||0.015|TWO_SIDED|95.0|-0.29|-0.03|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.03|-0.29|0.015
73982810|NCT00442559|147511270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16||||0.027|TWO_SIDED|95.0|-0.3|-0.02|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=29 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.02|-0.3|0.027
73982811|NCT00442559|147511271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.006|TWO_SIDED|95.0|-0.36|-0.07|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.07|-0.36|0.006
73982812|NCT00442559|147511271|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12||||0.032|TWO_SIDED|95.0|-0.24|-0.01|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=28 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.01|-0.24|0.032
73982813|NCT02604199|147511275|SUPERIORITY||LS Mean Difference|-0.086|STANDARD_ERROR_OF_MEAN|0.048||0.081|TWO_SIDED|95.0|-0.183|0.011||Mixed effect model repeat measurement (MMRM) includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.|MMRM|Within-subject covariance is unstructured.||||0.011|-0.183|0.0810
73982814|NCT02604199|147511275|SUPERIORITY||LS Mean Difference|-0.309|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.406|-0.212||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||||-0.212|-0.406|<.0001
73982815|NCT02604199|147511275|SUPERIORITY||LS Mean Difference|-0.223|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|-0.322|-0.124||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||||-0.124|-0.322|<.0001
73982816|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.089|STANDARD_ERROR_OF_MEAN|0.046||0.0583|TWO_SIDED|95.0|-0.181|0.003||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||0.003|-0.181|0.0583
74033807|NCT01718509|147620645|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.196||||0.002|TWO_SIDED|95.0|-0.321|-0.07|||ANCOVA|||||-0.070|-0.321|0.002
73982817|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.176|STANDARD_ERROR_OF_MEAN|0.045||0.003|TWO_SIDED|95.0|-0.267|-0.085||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||-0.085|-0.267|0.003
73982818|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.087|STANDARD_ERROR_OF_MEAN|0.047||0.067|TWO_SIDED|95.0|-0.181|0.006||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||0.006|-0.181|0.0670
73982819|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0875|TWO_SIDED|95.0|-0.151|0.011||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||0.011|-0.151|0.0875
73982820|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.179|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.259|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||-0.100|-0.259|<.0001
73982821|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.109|STANDARD_ERROR_OF_MEAN|0.041||0.0099|TWO_SIDED|95.0|-0.191|-0.027||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||-0.027|-0.191|0.0099
73982822|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.143|STANDARD_ERROR_OF_MEAN|0.043||0.0017|TWO_SIDED|95.0|-0.229|-0.057||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.057|-0.229|0.0017
73982823|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.265|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|-0.349|-0.18||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.180|-0.349|<.0001
74033808|NCT01718509|147620646|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.077||||0.234|TWO_SIDED|95.0|-0.205|0.05|||ANCOVA|||||0.050|-0.205|0.234
74033809|NCT01718509|147620647|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.03||||0.185|TWO_SIDED|95.0|-0.02|0.08|||ANCOVA|||||0.08|-0.02|0.185
74033810|NCT01718509|147620648|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel|||||||<0.001
74033811|NCT01718509|147620649|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.23|||<|0.001|TWO_SIDED|95.0|-2.77|-1.69||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-1.69|-2.77|<0.001
74033812|NCT01718509|147620650|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.27||||0.011|TWO_SIDED|95.0|0.29|2.24||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating||2.24|0.29|0.011
74033813|NCT01718509|147620650|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.6|||<|0.001|TWO_SIDED|95.0|-4.44|-2.76||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating||-2.76|-4.44|<0.001
74033814|NCT01718509|147620650|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.21|||<|0.001|TWO_SIDED|95.0|-5.09|-3.33||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger||-3.33|-5.09|<0.001
74033815|NCT01718509|147620651|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-9.28|||<|0.001|TWO_SIDED|95.0|-11.44|-7.12||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-7.12|-11.44|<0.001
74033816|NCT01718509|147620652|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.96||||0.298|TWO_SIDED|95.0|-2.77|0.85||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA|||||0.85|-2.77|0.298
73982824|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.122|STANDARD_ERROR_OF_MEAN|0.043||0.0072|TWO_SIDED|95.0|-0.209|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.035|-0.209|0.0072
74033817|NCT05209932|147620660|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.02|TWO_SIDED||||||ANCOVA|||||||0.02
74033818|NCT05209932|147620661|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.05|TWO_SIDED||||||ANCOVA|||||||0.05
74033819|NCT05209932|147620662|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED||||||ANCOVA|||||||0.07
74033820|NCT05209932|147620663|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.12||0.17|TWO_SIDED||||||ANCOVA|||||||0.17
74033821|NCT05209932|147620664|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
74033822|NCT05209932|147620665|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.03|TWO_SIDED||||||ANCOVA|||||||0.03
74033823|NCT05209932|147620666|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.09||0.01|TWO_SIDED||||||ANCOVA|||||||0.01
74033824|NCT05209932|147620667|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.19||0.04|TWO_SIDED||||||ANCOVA|||||||0.04
74033825|NCT05209932|147620668|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.1||0.02|TWO_SIDED||||||ANCOVA|||||||0.02
74033826|NCT05209932|147620669|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
73982825|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.118|STANDARD_ERROR_OF_MEAN|0.039||0.0043|TWO_SIDED|95.0|-0.197|-0.039||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.039|-0.197|0.0043
73982826|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.298|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.376|-0.221||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.221|-0.376|< 0.0001
73982827|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.181|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.261|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.100|-0.261|<.0001
73982828|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.132|STANDARD_ERROR_OF_MEAN|0.048||0.0084|TWO_SIDED|95.0|-0.228|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.035|-0.228|0.0084
73982829|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.338|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|-0.433|-0.243||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.243|-0.433|<.0001
73982830|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.206|STANDARD_ERROR_OF_MEAN|0.049||0.0001|TWO_SIDED|95.0|-0.304|-0.108||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.108|-0.304|0.0001
73982831|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.096|STANDARD_ERROR_OF_MEAN|0.05||0.0589|TWO_SIDED|95.0|-0.195|0.004||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||0.004|-0.195|0.0589
73982832|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.335|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|-0.433|-0.236||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||-0.236|-0.433|<.0001
73982833|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.239|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.34|-0.137||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||-0.137|-0.340|<.0001
73982834|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.132|STANDARD_ERROR_OF_MEAN|0.052||0.0138|TWO_SIDED|95.0|-0.236|-0.028||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.028|-0.236|0.0138
73982835|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.355|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.458|-0.252||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.252|-0.458|<.0001
73982836|NCT02604199|147511276|SUPERIORITY||LS Mean|-0.223|STANDARD_ERROR_OF_MEAN|0.053||0.0001|TWO_SIDED|95.0|-0.329|-0.117||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.117|-0.329|0.0001
73982837|NCT01885559|147511377|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.58|TWO_SIDED|95.0|0.82|1.42|||Regression, Cox|Analyses were adjusted for age, sex, race, baseline estimated Glomerular Filtration Rate (eGFR) and clinical site|ACE+ARB (Lisinopril-telmisartan) compared to ACE+placebo (Lisinopril-placebo)|||1.42|0.82|0.58
73982838|NCT01885559|147511378|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.88|TWO_SIDED|95.0|-3.2|2.8|||shared parameter model|shared parameter models used due to informative censoring that occurred when patients did not have secondary outcomes measured after reaching endpoint||||2.8|-3.2|0.88
74033827|NCT05209932|147620670|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.43|TWO_SIDED||||||ANCOVA|||||||0.43
74033828|NCT05209932|147620671|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.14||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
73982839|NCT01885559|147511379|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.17|TWO_SIDED|95.0|-3.9|0.7||controlling for age, sex, race, and clinical site|Mixed Models Analysis||ACE-I+ARB annual percent change minus ACE-I + placebo annual percent change|||0.7|-3.9|0.17
73982840|NCT01885559|147511380|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.85|TWO_SIDED|95.0|0.8|1.32|||Regression, Cox|adjusting for age, sex, race, and clinical site and recurrent events|Hazard ratio compares ACE-I + ARB compared to ACE-I + placebo|||1.32|0.80|0.85
73982841|NCT01885559|147511381|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.57|TWO_SIDED|95.0|0.42|1.6|||Regression, Cox|adjusting for age, sex, race, and clinical site and accounting for recurrent events|Hazard ratio is comparing ACE-I + ARB to ACE-I + placebo|||1.6|0.42|0.57
74033829|NCT05209932|147620672|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||ANCOVA|||||||0.03
74033830|NCT05209932|147620673|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.63|TWO_SIDED||||||ANCOVA|||||||0.63
74033831|NCT05209932|147620674|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|0.8||0.29|TWO_SIDED||||||ANCOVA|||||||0.29
74033832|NCT05209932|147620675|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-1.08|STANDARD_ERROR_OF_MEAN|1.12||0.33|TWO_SIDED||||||ANCOVA|||||||0.33
73982842|NCT01885559|147511382|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.032||||0.75|TWO_SIDED|95.0|-0.23|0.16|||shared parameter model|Shared parameter models were used due to informed censoring when patients who reached the primary endpoint were no longer assessed on the measure.||||0.16|-0.23|0.75
73982843|NCT01885559|147511383|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.047||||0.66|TWO_SIDED|95.0|-0.26|0.16|||shared parameter model|Shared parameter models were used due to the informative censoring when patients who reached endpoint were not longer assessed on this measure.||||0.16|-0.26|0.66
73982844|NCT01885559|147511384|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||0.64|TWO_SIDED|95.0|0.99|1.01|||Mixed Models Analysis|Generalized linear mixed models are used with a logit link. Model controlled for baseline age, sex, race, and clinical site.|"Odds ratio represents the multiplicative effect of ACE-I + ARB group compared to the ACE-I + placebo group in change in pain over time.~ACE-I + ARB OR per month was 1.01 (1.00, 1.01) and ACE-I + placebo OR was 1.01 (1.01, 1.01)."|||1.01|0.99|0.64
73982845|NCT00738400|147511387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.76|||<|0.0001||95.0|-9.03|-4.49|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-4.49|-9.03|<0.0001
73982846|NCT00738400|147511388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.71|||<|0.0001||95.0|-30.66|-10.76|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-10.76|-30.66|<0.0001
73982847|NCT00738400|147511389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.16|||<|0.0001||95.0|-37.48|-14.83|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-14.83|-37.48|<0.0001
73982848|NCT00738400|147511390|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mantel Haenszel|||Mantel-Haenszel Test||||0.0004
73982849|NCT00738400|147511391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.57||||0.0003||95.0|-23.8|-7.34|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-7.34|-23.80|0.0003
73982850|NCT00738400|147511392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.33|||<|0.0001||95.0|-37.24|-17.43|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-17.43|-37.24|<0.0001
73982851|NCT02819141|147511409|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance was p \< 0.05.|Generalized estimating equations|Controlling for age, daily sequential organ failure assessment (SOFA) score, sedation intensity, and time of day of assessment||We estimated the power for multilevel models approximating our study design. A sample size of 95 patients per arm, 190 total (at a minimum 7 data collection points for each, resulting in \~1,050 observations) will have greater than 80% power to detect small to moderate effects (i.e., 0.11 or greater) in between-group differences in anxiety, delirium, and duration of mechanical ventilation at alpha = .05 for all proposed models.||||0.30
73982852|NCT02819141|147511409|SUPERIORITY|Controlling for time of day, study day, age, sex, illness severity, and sedation frequency||||||0.9858|||||||Generalized Estimating equations|||||||0.9858
73982853|NCT02819141|147511410|SUPERIORITY|||||||0.02||||||a priori threshold for significance p \< 0.05.|t-test, 1 sided|||||||0.02
73982854|NCT02819141|147511411|SUPERIORITY|||||||0.97|||||||Generalized estimating equations|Controlling for sedation intensity, age, daily Sequential Organ Failure Assessment (SOFA) score, study day, and time of day assessment||||||0.97
73982855|NCT02819141|147511411|SUPERIORITY|||||||0.5647|||||||Generalized estimating equations|Controlling for sedation frequency, age, sex, illness severity, study day, and time of day assessment.||||||0.5647
74033833|NCT05209932|147620676|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|1.03||0.005|TWO_SIDED||||||ANCOVA|||||||0.005
74033834|NCT05209932|147620677|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.42|TWO_SIDED||||||ANCOVA|||||||0.42
74033835|NCT05209932|147620678|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.3||0.97|TWO_SIDED||||||ANCOVA|||||||0.97
74033836|NCT01219959|147620688|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
73982856|NCT02819141|147511412|SUPERIORITY|||||||0.39|||||||Generalized estimating equation|controlling for age, daily Sequential Organ Failure Assessment (SOFA) score, time of day of assessment||||||0.39
73982857|NCT02819141|147511413|SUPERIORITY|||||||0.37|||||||GEE|||||||0.37
74033837|NCT01219959|147620688|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
73982858|NCT02819141|147511414|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
73982859|NCT02819141|147511414|SUPERIORITY|||||||0.81|||||||t-test, 1 sided|||||||0.81
73982860|NCT02819141|147511415|SUPERIORITY|||||||0.47|||||||t-test, 1 sided|||||||0.47
73982861|NCT02819141|147511415|SUPERIORITY|||||||0.82|||||||t-test, 1 sided|||||||0.82
73982862|NCT02819141|147511416|SUPERIORITY|||||||0.164|||||||t-test, 1 sided|||3 months after ICU discharge||||0.164
73982863|NCT02819141|147511416|SUPERIORITY|||||||0.84|||||||t-test, 1 sided|||6 months after ICU discharge||||0.84
73982864|NCT02819141|147511417|SUPERIORITY|||||||0.26|||||||t-test, 1 sided|||||||0.26
73982865|NCT02819141|147511418|SUPERIORITY|||||||0.82|||||||t-test, 1 sided|||||||0.82
73982866|NCT02819141|147511419|SUPERIORITY|||||||0.018|||||||t-test, 1 sided|||||||0.018
73982867|NCT02819141|147511420|SUPERIORITY|||||||0.66|||||||t-test, 1 sided|||||||0.66
73982868|NCT02819141|147511421|SUPERIORITY|||||||0.63|||||||t-test, 1 sided|||||||0.63
73982869|NCT02819141|147511422|SUPERIORITY|||||||0.41|||||||t-test, 1 sided|||||||0.41
73982870|NCT02819141|147511423|SUPERIORITY|||||||0.06|||||||t-test, 1 sided|||||||0.06
73982871|NCT02819141|147511424|SUPERIORITY|||||||0.93|||||||t-test, 1 sided|||||||0.93
73982872|NCT02819141|147511425|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||||||0.43
74033838|NCT01219959|147620689|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
74033839|NCT01219959|147620689|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
74033840|NCT01219959|147620691|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
73982873|NCT02819141|147511426|SUPERIORITY|||||||0.69|||||||t-test, 1 sided|||||||0.69
73982874|NCT02819141|147511427|SUPERIORITY|||||||0.94|||||||t-test, 1 sided|||||||0.94
73982875|NCT02819141|147511428|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|||||||0.50
73982876|NCT02819141|147511429|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||||||0.03
73982877|NCT02819141|147511430|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
73982878|NCT02819141|147511431|SUPERIORITY|||||||0.85|||||||t-test, 1 sided|||||||0.85
73982879|NCT02819141|147511432|SUPERIORITY|||||||0.95|||||||t-test, 1 sided|||||||0.95
73982880|NCT04396860|147511446|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.96|TWO_SIDED|95.0|0.98|2.21|||Log Rank|Stratified log-rank|Reference level = Arm 1|For the phase II endpoint, observation of 100 PFS events among the 150 randomized patients (from both arms) provides 95% statistical power to detect an improvement in median PFS from 5.7 months in the control arm to 9.7 months in the experimental arm, corresponding to a hazard reduction of 42% (hazard ratio 0.58) at one-sided significance level of 0.15 (and 87% power for hazard ratio of 0.65 at this same alpha).||2.21|0.98|0.96
73982881|NCT02282761|147511484|SUPERIORITY||Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.83||0.182|TWO_SIDED|95.0|-6.17|1.05|||Mixed Effects Model for Repeated Measure|||||1.05|-6.17|0.182
73982882|NCT02282761|147511484|SUPERIORITY||Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.82||0.045|TWO_SIDED|95.0|-7.75|-0.6|||Mixed Effects Model for Repeated Measure|||||-0.60|-7.75|0.045
73982883|NCT02282761|147511485|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.045|TWO_SIDED|95.0|-0.54|-0.12|||Mixed Effects Model for Repeated Measure|||||-0.12|-0.54|0.045
73982884|NCT05878522|147511491|OTHER||LS Mean difference|11.73|||||TWO_SIDED|90.0|8.89|14.58||||||3- hours post-dose||14.58|8.89|
73982885|NCT05878522|147511491|OTHER||LS Mean difference|11.35|||||TWO_SIDED|90.0|8.5|14.2||||||4-hours post-dose||14.20|8.50|
73982886|NCT05878522|147511491|OTHER||LS Mean difference|8.35||||||90.0|5.51|11.2||||||5-hours post-dose||11.20|5.51|
73982887|NCT02252172|147511500|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.43|0.73|||Log Rank|||||0.73|0.43|<0.0001
73982888|NCT01842360|147511554|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
73982889|NCT01842360|147511555|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Poisson|||||||<0.001
73982890|NCT01842360|147511556|SUPERIORITY|||||||0.0094|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean of health care consumption was 17.5±34.7 points in the placebo group versus 9.2±27.9 points in the MV130 group.||||0.0094
73982891|NCT01842360|147511557|SUPERIORITY|||||||0.3917|TWO_SIDED|95.0|||||Log Rank|||||||0.3917
73982892|NCT01842360|147511558|SUPERIORITY|||||||0.0232|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||As for the previous index the number of days with any of these drugs is used.||||0.0232
73982893|NCT01842360|147511559|SUPERIORITY|||||||0.0319|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0319
73982894|NCT01842360|147511560|SUPERIORITY|||||||0.0264|||||||Wilcoxon (Mann-Whitney)|||||||0.0264
73982895|NCT01842360|147511561|SUPERIORITY|||||||0.0037|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean number of emergency room visits was 0.37 (±1.15) for the MV130 group and 0.87 (±1.61) for the placebo group.||||0.0037
73982896|NCT01842360|147511562|SUPERIORITY|||||||0.1008|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean number of medical consultations was 0.08 (±0.31) for the MV130 group and 0.31 (±0.88) for the placebo group.||||0.1008
73982897|NCT01842360|147511563|SUPERIORITY|||||||0.0367|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.0367
74033841|NCT01219959|147620691|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
74033842|NCT01219959|147620691|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
74033843|NCT01219959|147620691|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
74033844|NCT01219959|147620691|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
74033845|NCT01219959|147620691|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
73982898|NCT01842360|147511565|SUPERIORITY|||||||0.3234|TWO_SIDED|95.0|||||Fisher Exact|||||||0.3234
73982899|NCT01842360|147511566|SUPERIORITY|||||||0.001|||||||Log Rank|||||||0.001
73982900|NCT04551053|147511568|SUPERIORITY|p-value for superiority is half of the CMH p-value.|Odds Ratio (OR)|1.8||||0.2567|TWO_SIDED|95.0|0.65|5.02||CMH test for un-equality stratified by Dynamic International Prognostic Scoring System (DIPSS) category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 × 10\^9/Liters \[L\] versus 50 to \<100 × 10\^9/L inclusive)|Cochran-Mantel-Haenszel|||||5.02|0.65|0.2567
73982901|NCT04551053|147511569|SUPERIORITY|p-value for superiority is half of the CMH p-value.|Odds Ratio (OR)|1.34||||0.5349|TWO_SIDED|95.0|0.53|3.39||calculated from Cochran Mantel-Haenszel test for un-equality stratified by DIPSS category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 × 10\^9/L versus 50 to \<100 × 10\^9/L inclusive)|Cochran-Mantel-Haenszel|||||3.39|0.53|0.5349
73982902|NCT04551053|147511571|SUPERIORITY|||||||0.2224||||||calculated from log-rank test stratified by DIPSS category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 x 10\^9/L versus 50 to \<100 x 10\^9/L inclusive)|Log Rank|||||||0.2224
73982903|NCT02389894|147511585|SUPERIORITY||Risk Difference (RD)|6.9||||0.22|TWO_SIDED|95.0|-4.2|17.9|||Chi-squared|The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Embol-x minus control|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.||17.9|-4.2|0.22
73874120|NCT01775371|147290352|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.5||The a priori threshold for statistical significance was 0.05.|Z-test 2-sided||The direction of the comparison is the Patient Controlled Analgesia minus the standard care group|The rate of change of NRS pain scores per hour was calculated using a mixed effects linear model. Time is represented as a linear spline with knot at 30 minutes to support the separate estimation of early and late phase rates of change. Fixed effects in the analysis includes study-group indicator, early and late phase time, and interactions between study-group and time. The principal hypothesis test was a z-test of the coefficient of the study group late phase interaction term.||1.5|0.6|<0.001
73874121|NCT01775371|147290353|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
73874122|NCT01775371|147290354|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
73874123|NCT01775371|147290355|OTHER|Responses occur with equal probability|||||<|0.001|||||||Chi-squared|One-sample chi-squared test of hypothesis that the responses occur with equal probability||These outcomes are based on the nurses who took care of patients in the study||||<0.001
73874124|NCT01775371|147290356|OTHER|All responses occur with equal probability|||||<|0.001|||||||Chi-squared|One-sample chi-squared test of hypothesis that the responses occur with equal probability||This outcome is based on the physicians who took care of the patients in the study||||<0.001
73874125|NCT04915729|147290390|NON_INFERIORITY|pre-specified non-inferiority margin for risk ratio = 0.937|Risk Ratio (RR)|1.0278|||||TWO_SIDED|95.0|0.9678|1.0915|||Modified Possion Regression Model|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.0915|0.9678|
73874126|NCT04915729|147290391|OTHER|log-binomial regression model|Risk Ratio (RR)|1.0671||||0.2412|TWO_SIDED|95.0|0.9573|1.1895||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = covariates|tenecteplase versus alteplase|||1.1895|0.9573|0.2412
73874127|NCT04915729|147290392|OTHER|Modified Poisson regression model|Risk Ratio (RR)|1.0078||||0.748|TWO_SIDED|95.0|0.9614|1.0564||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.0564|0.9614|0.7480
73874128|NCT04915729|147290393|OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.48||0.3511|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|baseline NIHSS, age, time to administration since stroke symptoms onset = linear covariates; treatment = fixed effects|Difference in LSmean tenecteplase vs alteplase|||0.50|-1.40|0.3511
73874129|NCT04915729|147290394|OTHER||Odds Ratio (OR)|1.0418||||0.4806|||||||Regression, Logistic|Assumption-free ordinal analysis|tenecteplase versus alteplase|||||0.4806
73982904|NCT02389894|147511585|SUPERIORITY||Risk Difference (RD)|1.3||||0.84|TWO_SIDED|95.0|-11.2|13.8||The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|Chi-squared||The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Cardiogard minus control.|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.||13.8|-11.2|0.84
73982905|NCT02389894|147511586|SUPERIORITY||Risk Difference (RD)|9.7||||0.08|TWO_SIDED|95.0|-1.2|20.5|||Chi-squared||The absolute difference was computed as Embol-x minus control|||20.5|-1.2|0.08
73982906|NCT02389894|147511586|SUPERIORITY||Risk Difference (RD)|-2.8||||0.61|TWO_SIDED|95.0|-13.5|7.9|||Chi-squared||The absolute difference was computed as Cardiogard minus control|||7.9|-13.5|0.61
73982907|NCT06091982|147511640|SUPERIORITY||Odds Ratio (OR)|10.6|||<|0.0001|TWO_SIDED|95.0|7.0|16.2|||Chi-squared|||Bivariable analysis of both groups||16.2|7.0|<0.0001
73982908|NCT06091982|147511640|OTHER|Multiple logistic regression|Odds Ratio, log|3.4|||<|0.0001|TWO_SIDED|95.0|2.0|6.1|||Regression, Logistic|||Multivariable analysis||6.1|2.0|<0.0001
73982909|NCT06091982|147511641|SUPERIORITY||Odds Ratio (OR)|12.5|||<|0.0001|TWO_SIDED|95.0|9.1|17.1|||Chi-squared|||||17.1|9.1|<0.0001
73982910|NCT06091982|147511641|SUPERIORITY||Odds Ratio, log|4.4|||<|0.0001|TWO_SIDED|95.0|2.8|7.0|||Regression, Logistic|||||7.0|2.8|<0.0001
73874130|NCT04915729|147290395|OTHER|Poisson regression model|Risk Ratio (RR)|1.0189||||0.5116|TWO_SIDED|95.0|0.9635|1.0774|||Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = covariates|tenecteplase versus alteplase|||1.0774|0.9635|0.5116
73874131|NCT04915729|147290396|OTHER||Risk Ratio (RR)|1.005||||1|TWO_SIDED|95.0|0.37|2.701|||Suissa-Shuster test||tenecteplase versus alteplase|||2.701|0.370|1.000
73874132|NCT04915729|147290397|OTHER||Risk Ratio (RR)|0.795||||0.303|TWO_SIDED|95.0|0.513|1.232|||Chi-squared||tenecteplase versus alteplase|||1.232|0.513|0.303
73874133|NCT04915729|147290398|OTHER|Modified Poisson regression model|Risk Ratio (RR)|0.9215||||0.6345|TWO_SIDED|95.0|0.6578|1.2908||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.2908|0.6578|0.6345
73874134|NCT00587678|147290401|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Linear repeated measures model|||||||0.32
73874135|NCT00587678|147290401|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||vs. baseline|Linear repeated measures model|||||||<0.01
73874136|NCT00587678|147290402|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Linear repeated measures model|||||||0.31
73874137|NCT00587678|147290402|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||vs. baseline|Linear repeated measures model|||||||<0.05
73874138|NCT00587678|147290403|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Linear repeated measures model|||||||0.71
73874139|NCT00587678|147290404|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Linear repeated measures model|||||||0.67
73874140|NCT00587678|147290405|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Linear repeated measures model|||||||0.37
73874141|NCT00587678|147290405|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||vs. baseline|Linear repeated measures model|||||||<0.05
73874142|NCT00587678|147290406|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Linear repeated measures model|||||||0.78
73982911|NCT06091982|147511642|SUPERIORITY||Odds Ratio (OR)|15.6|||<|0.0001|TWO_SIDED|95.0|11.3|21.6|||Chi-squared|||||21.6|11.3|<0.0001
73982912|NCT06091982|147511642|OTHER||Odds Ratio, log|5.2|||<|0.0001|TWO_SIDED|95.0|3.3|8.2|||Regression, Logistic|||||8.2|3.3|<0.0001
73982913|NCT01375777|147511716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.23|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-54.52|-39.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-39.93|-54.52|<0.001
73982914|NCT01375777|147511716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.17|STANDARD_ERROR_OF_MEAN|3.66|<|0.001||95.0|-47.38|-32.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-32.95|-47.38|<0.001
73982915|NCT01375777|147511716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.27|STANDARD_ERROR_OF_MEAN|3.68|<|0.001|TWO_SIDED|95.0|-44.53|-30.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-30.02|-44.53|<0.001
73982916|NCT01375777|147511716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.53|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-59.67|-45.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-45.38|-59.67|<0.001
73982917|NCT01375777|147511716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.74|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-54.89|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-40.60|-54.89|<0.001
73982918|NCT01375777|147511716|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.57|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-50.71|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.42|-50.71|<0.001
73982919|NCT01375777|147511717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.9|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|-76.3|-55.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-55.6|-76.3|<0.001
73982920|NCT01375777|147511717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.7|STANDARD_ERROR_OF_MEAN|5.3|<|0.001||95.0|-73.2|-52.2||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-52.2|-73.2|<0.001
73982921|NCT01375777|147511717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.3|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-62.7|-41.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-41.9|-62.7|<0.001
73982922|NCT01375777|147511717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-72.3|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-82.2|-62.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-62.4|-82.2|<0.001
73982923|NCT01375777|147511717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-63.9|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-73.9|-54.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-54.0|-73.9|<0.001
73982924|NCT01375777|147511717|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-70.7|-50.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-50.9|-70.7|<0.001
73982925|NCT01375777|147511718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.15|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-51.72|-38.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-38.58|-51.72|<0.001
73982926|NCT01375777|147511718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.79|STANDARD_ERROR_OF_MEAN|3.29|<|0.001||95.0|-43.29|-30.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-30.29|-43.29|<0.001
73982927|NCT01375777|147511718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.06|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-41.59|-28.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-28.52|-41.59|<0.001
74033846|NCT01219959|147620691|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
74033847|NCT01219959|147620691|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
74033848|NCT01219959|147620691|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
73874143|NCT00587678|147290407|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Linear repeated measures model|||||||0.68
73982928|NCT01375777|147511718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.11|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-53.33|-40.89||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-40.89|-53.33|<0.001
73982929|NCT01375777|147511718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.89|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-48.11|-35.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-35.67|-48.11|<0.001
73982930|NCT01375777|147511718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.7|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-43.92|-31.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.47|-43.92|<0.001
73982931|NCT01375777|147511719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.19|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-50.45|-37.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-37.94|-50.45|<0.001
73982932|NCT01375777|147511719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.87|STANDARD_ERROR_OF_MEAN|3.13|<|0.001||95.0|-42.06|-29.69||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-29.69|-42.06|<0.001
73982933|NCT01375777|147511719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.33|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-38.55|-26.11||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-26.11|-38.55|<0.001
73982934|NCT01375777|147511719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.48|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-48.63|-36.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-36.32|-48.63|<0.001
74033849|NCT01219959|147620691|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
73874144|NCT00587678|147290408|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Linear repeated measures model|||||||<0.05
73982935|NCT01375777|147511719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.92|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-44.07|-31.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.76|-44.07|<0.001
73982936|NCT01375777|147511719|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.22|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-39.38|-27.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-27.07|-39.38|<0.001
73982937|NCT01375777|147511720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.49|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-43.43|-31.54||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.54|-43.43|<0.001
73982938|NCT01375777|147511720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.92|STANDARD_ERROR_OF_MEAN|2.98|<|0.001||95.0|-37.79|-26.04||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-26.04|-37.79|<0.001
73982939|NCT01375777|147511720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.86|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-34.77|-22.95||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-22.95|-34.77|<0.001
73982940|NCT01375777|147511720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.58|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-42.29|-30.88||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-30.88|-42.29|<0.001
73982941|NCT01375777|147511720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.21|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-36.92|-25.51||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-25.51|-36.92|<0.001
74033850|NCT01219959|147620692|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
73982942|NCT01375777|147511720|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.69|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-34.39|-22.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-22.98|-34.39|<0.001
73982943|NCT01375777|147511721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.16|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-56.75|-43.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-43.58|-56.75|<0.001
73982944|NCT01375777|147511721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.33|STANDARD_ERROR_OF_MEAN|3.3|<|0.001||95.0|-46.84|-33.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-33.82|-46.84|<0.001
73874145|NCT00587678|147290409|SUPERIORITY_OR_OTHER||||||=|0.67||95.0|||||linear repeated measures model|||||||=0.67
73874146|NCT00587678|147290410|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Linear repeated measures model|||||||0.77
73874147|NCT00587678|147290411|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Linear repeated measures model|||||||0.85
73874148|NCT03710642|147290412|SUPERIORITY||Mean Difference (Net)|-0.008096||||0.9904|TWO_SIDED||||||Regression, Linear|||||||0.9904
73874149|NCT03710642|147290413|SUPERIORITY||Mean Difference (Net)|-11.54||||0.30328|TWO_SIDED||||||Regression, Linear|||||||0.30328
73874150|NCT03710642|147290414|SUPERIORITY||Mean Difference (Net)|0.31122||||0.21981|TWO_SIDED||||||Regression, Linear|||||||0.21981
73982945|NCT01375777|147511721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.83|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-41.38|-28.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-28.28|-41.38|<0.001
73982946|NCT01375777|147511721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.47|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-52.12|-38.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-38.82|-52.12|<0.001
73982947|NCT01375777|147511721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.57|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-47.22|-33.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-33.92|-47.22|<0.001
73982948|NCT01375777|147511721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.25|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-42.9|-29.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-29.60|-42.90|<0.001
73982949|NCT01136733|147511731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||=|0.0005|TWO_SIDED|95.0|0.24|0.68|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Null hypothesis of no difference in PFS was analyzed using the stratified log-rank test with hemoglobin (less than or equal to 13 g/dL vs greater than 13 g/dL for males; and less than or equal to 11.5 g/dL vs greater than 11.5 g/dL for females) and corrected serum calcium (greater than or equal to 10 mg/dL vs less than 10 mg/dL) as stratification factors. Each null hypothesis was tested at a nominal alpha=0.05.||0.68|0.24|=0.0005
73982950|NCT01136733|147511731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0479|TWO_SIDED|95.0|0.38|0.98|||Log Rank|||||0.98|0.38|0.0479
73982951|NCT01136733|147511731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.1209|TWO_SIDED|95.0|0.39|1.1|||Log Rank|||||1.10|0.39|0.1209
73982952|NCT01136733|147511732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.514|||=|0.0242|TWO_SIDED|95.0|0.299|0.884|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Planned analyses were performed to test null hypothesis of treatment difference in OS at a nominal significance level of 0.05 (2-sided) using the stratified log-rank test using stratification factors.||0.884|0.299|=0.0242
73982953|NCT01136733|147511732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.684|||=|0.1181|TWO_SIDED|95.0|0.411|1.138|||Log Rank|||||1.138|0.411|=0.1181
73982954|NCT01136733|147511732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751|||=|0.3157|TWO_SIDED|95.0|0.433|1.301|||Log Rank|||||1.301|0.433|=0.3157
73982955|NCT01136733|147511733|SUPERIORITY_OR_OTHER||Rate ratio|7.2|||<|0.0001|TWO_SIDED|95.0|2.3|22.5||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact||Rate ratio was based on the normal approximation.|||22.5|2.3|<0.0001
73982956|NCT01136733|147511733|SUPERIORITY_OR_OTHER||Rate ratio|4.5||||0.0067|TWO_SIDED|95.0|1.4|14.7||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact|||||14.7|1.4|0.0067
73982957|NCT01136733|147511733|SUPERIORITY_OR_OTHER||Rate ratio|1.6|||=|0.1007|TWO_SIDED|95.0|0.9|2.8||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact|||||2.8|0.9|=0.1007
73982958|NCT00125619|147511746|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Between group comparison of Robot (Lokomat) vs. Manual (therapist-assisted) training.||||0.72
73982959|NCT00125619|147511746|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Robot (Lokomat) training.||||<.05
73982960|NCT00125619|147511746|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Manual (Therapist Assisted) training.||||>.05
73982961|NCT00125619|147511747|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of Robot vs. Manual training.||||>0.05
73982962|NCT00125619|147511747|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison (pre- vs. post-treatment) due to Manual (therapist-assisted) treatment.||||>.05
73982963|NCT00125619|147511747|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within-groups comparison of pre- vs. post-treatment effects for Robot (Lokomat) training.||||<.05
73982964|NCT00125619|147511748|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of robot vs. manual training.||||>.05
73982965|NCT00125619|147511748|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects for manual training.||||>.05
73982966|NCT00125619|147511748|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon signed ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||>.05
73982967|NCT00125619|147511749|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of effects of robot vs. manual training.||||>.05
73982968|NCT00125619|147511749|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison of pre- vs. post-treatment effects of manual training.||||>.05
73982969|NCT00125619|147511749|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of robot training.||||<.05
73982970|NCT00125619|147511750|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
73982971|NCT00125619|147511750|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within groups comparison for pre- vs. post-training effects of manual training.||||>.05
73982972|NCT00125619|147511750|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within group comparison for pre- vs. post-training effects of robot training.||||>.05
73982973|NCT00125619|147511751|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
74033851|NCT01219959|147620692|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
74033852|NCT01219959|147620692|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
73982974|NCT00125619|147511751|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.||||>.05
73982975|NCT00125619|147511751|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||<.05
73982976|NCT00125619|147511752|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
73982977|NCT00125619|147511752|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.||||<.05
73982978|NCT00125619|147511752|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||<.05
73982979|NCT00168805|147511772|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-1.3||||0.6648||95.0|-7.3|4.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.6|-7.3|0.6648
73982980|NCT00168805|147511772|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|2.8||||0.3553||95.0|-3.1|8.7||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||8.7|-3.1|0.3553
73982981|NCT00168805|147511773|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.0||||0.376||95.0|-3.1|1.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.2|-3.1|0.3760
73982982|NCT00168805|147511773|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.8151||95.0|-2.0|2.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.6|-2.0|0.8151
73982983|NCT00168805|147511774|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.8||||0.4715||95.0|-2.8|1.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.3|-2.8|0.4715
73982984|NCT00168805|147511774|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.1||||0.9325||95.0|-2.1|2.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.3|-2.1|0.9325
73982985|NCT00168805|147511775|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.4||||0.6463||95.0|-7.3|4.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.5|-7.3|0.6463
73982986|NCT00168805|147511775|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|2.7||||0.374||95.0|-3.2|8.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||8.6|-3.2|0.3740
73982987|NCT00168805|147511776|SUPERIORITY_OR_OTHER|||||||0.0385||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0385
73982988|NCT00168805|147511776|SUPERIORITY_OR_OTHER|||||||0.1414||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1414
73982989|NCT00168805|147511777|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
73982990|NCT00168805|147511777|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
73982991|NCT00168805|147511778|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
73982992|NCT00168805|147511778|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
73982993|NCT00168805|147511780|SUPERIORITY_OR_OTHER|||||||0.8209||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.8209
73982994|NCT00168805|147511780|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
73982995|NCT01114217|147511784|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73982996|NCT01183013|147511792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.1571||95.0|-0.41|0.07||The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.|ANCOVA|||Treatment comparisons are for fixed dose combination versus monotherapy.||0.07|-0.41|0.1571
73982997|NCT01183013|147511792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0016|TWO_SIDED|95.0|-0.6|-0.14|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.14|-0.60|0.0016
73982998|NCT01183013|147511792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0006|TWO_SIDED|95.0|-0.64|-0.18|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.18|-0.64|0.0006
73982999|NCT01183013|147511792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0003|TWO_SIDED|95.0|-0.67|-0.2|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.20|-0.67|0.0003
73983000|NCT01183013|147511792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.44|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.44|-0.91|<0.0001
74033853|NCT01219959|147620692|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
73983001|NCT01183013|147511792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.12|-0.66|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.66|-1.12|<0.0001
73983002|NCT01183013|147511793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.246||||0.4639||95.0|0.692|2.242|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.242|0.692|0.4639
73874151|NCT03710642|147290415|SUPERIORITY||Cox Proportional Hazard|-0.36277||||0.6366|TWO_SIDED||||||Regression, Cox|||||||0.6366
73874152|NCT03710642|147290416|SUPERIORITY||Slope|-0.12842|STANDARD_ERROR_OF_MEAN|1.39602||0.9267|TWO_SIDED||||||Regression, Logistic|||||||0.9267
73874153|NCT03710642|147290417|SUPERIORITY||Mean Difference (Net)|3.0694||||0.2038|TWO_SIDED||||||Regression, Linear|||||||0.2038
73983003|NCT01183013|147511793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.746||||0.0546||95.0|0.989|3.083|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.083|0.989|0.0546
73983004|NCT01183013|147511793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.903||||0.0254||95.0|1.083|3.345|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.345|1.083|0.0254
73983005|NCT01183013|147511793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.804||||0.0009||95.0|1.524|5.159|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.159|1.524|0.0009
73983006|NCT01183013|147511793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.429|||<|0.0001||95.0|2.947|10.001|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||10.001|2.947|<0.0001
73983007|NCT01183013|147511793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.614|||<|0.0001||95.0|5.187|17.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||17.821|5.187|<0.0001
73874154|NCT03710642|147290418|SUPERIORITY||Mean Difference (Net)|-3.388||||0.54133|TWO_SIDED||||||Regression, Linear|||||||0.54133
73983008|NCT01183013|147511794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.126||||0.7359||95.0|0.565|2.243|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.243|0.565|0.7359
73983009|NCT01183013|147511794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.905||||0.0363||95.0|1.042|3.484|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.484|1.042|0.0363
73983010|NCT01183013|147511794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.269||||0.4039||95.0|0.726|2.217|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.217|0.726|0.4039
73983011|NCT01183013|147511794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0345||95.0|1.06|4.649|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||4.649|1.060|0.0345
73983012|NCT01183013|147511794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001||95.0|2.263|9.266|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||9.266|2.263|<0.0001
73983013|NCT01183013|147511794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.066|||<|0.0001||95.0|2.53|10.145|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||10.145|2.530|<0.0001
73983014|NCT01183013|147511795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.754||95.0|0.637|1.863|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.863|0.637|0.7540
73983015|NCT01183013|147511795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.707||||0.0506||95.0|0.999|2.918|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.918|0.999|0.0506
73983016|NCT01183013|147511795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.966||||0.0005|TWO_SIDED|95.0|1.604|5.485|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.485|1.604|0.0005
74033854|NCT01219959|147620692|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
74033855|NCT01219959|147620692|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
73874155|NCT05282927|147290422|SUPERIORITY||Mean Difference (Net)|-0.05||||0.92|TWO_SIDED|95.0|-1.07|0.98|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization: site complexity level (high complexity '1a', '1b' or '1c' vs. all others) and rurality (high sites serving ≥50% rural/highly rural Veterans vs. low sites serving \<50% rural/highly rural Veterans)||0.98|-1.07|0.92
73874156|NCT05282927|147290423|SUPERIORITY||Mean Difference (Net)|0.94||||0.056|TWO_SIDED|95.0|-0.03|1.9|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization: site complexity level (high complexity '1a', '1b' or '1c' vs. all others) and rurality (high sites serving ≥50% rural/highly rural Veterans vs. low sites serving \<50% rural/highly rural Veterans).||1.90|-0.03|0.056
73874157|NCT01010971|147290459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|||<|0.0001|TWO_SIDED|95.0|0.59|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.45|0.59|<0.0001
73983017|NCT01183013|147511795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.696||||0.0002||95.0|1.594|4.559|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||4.559|1.594|0.0002
73983018|NCT01183013|147511795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.017|||<|0.0001||95.0|2.348|6.873|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||6.873|2.348|<0.0001
73983019|NCT01183013|147511795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.521|||<|0.0001||95.0|4.63|15.681|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||15.681|4.630|<0.0001
73983020|NCT01183013|147511797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68||||0.4275|TWO_SIDED|95.0|-12.77|5.42|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.42|-12.77|0.4275
73983021|NCT01183013|147511797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84||||0.6839|TWO_SIDED|95.0|-10.69|7.02|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||7.02|-10.69|0.6839
73983022|NCT01183013|147511797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.1466|TWO_SIDED|95.0|-15.29|2.28|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.28|-15.29|0.1466
73983023|NCT01183013|147511797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.38||||0.0002|TWO_SIDED|95.0|-26.35|-8.41|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-8.41|-26.35|0.0002
73983024|NCT01183013|147511797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.87|||<|0.0001|TWO_SIDED|95.0|-34.77|-16.98|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-16.98|-34.77|<0.0001
73983025|NCT01183013|147511797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.73|||<|0.0001|TWO_SIDED|95.0|-42.57|-24.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-24.89|-42.57|<0.0001
73983026|NCT01183013|147511799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.61||||0.0057|TWO_SIDED|95.0|-62.42|-10.8|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-10.80|-62.42|0.0057
73983027|NCT01183013|147511799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.94||||0.7021||95.0|-30.39|20.51|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||20.51|-30.39|0.7021
73983028|NCT01183013|147511799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||0.8932|TWO_SIDED|95.0|-27.95|24.38|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||24.38|-27.95|0.8932
73983029|NCT01183013|147511799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65||||0.2706|TWO_SIDED|95.0|-43.6|12.3|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||12.30|-43.60|0.2706
73983030|NCT01183013|147511799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.33||||0.0126|TWO_SIDED|95.0|-64.78|-7.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-7.89|-64.78|0.0126
73983031|NCT01183013|147511799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.16||||0.0167|TWO_SIDED|95.0|-60.23|-6.08|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-6.08|-60.23|0.0167
73983032|NCT01183013|147511801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.649||||0.3052||95.0|0.284|1.482|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.482|0.284|0.3052
73983033|NCT01183013|147511801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.456||||0.0844|TWO_SIDED|95.0|0.187|1.112|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.112|0.187|0.0844
74033856|NCT01219959|147620693|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
74033857|NCT01219959|147620693|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
74033858|NCT01219959|147620693|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
74033859|NCT01219959|147620693|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
74033860|NCT01219959|147620694|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
73983034|NCT01183013|147511801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.443||||0.1561|TWO_SIDED|95.0|0.143|1.365|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.365|0.143|0.1561
73983035|NCT01183013|147511801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.368||||0.0146||95.0|0.165|0.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.821|0.165|0.0146
73983036|NCT01183013|147511801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.238||||0.0009||95.0|0.102|0.557|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.557|0.102|0.0009
73983037|NCT01183013|147511801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.141||||0.0002||95.0|0.05|0.397|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.397|0.050|0.0002
73983038|NCT00472199|147511808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.0||0.0077||95.0|-4.6|-0.7|||ANCOVA|||Analysis of covariance for changes from baseline with factors treatment and country and using baseline as covariate||-0.7|-4.6|0.0077
73983039|NCT00472199|147511809|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0010
73983040|NCT00472199|147511810|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||Cochran-Mantel-Haenszel|||||||0.0044
73983041|NCT00472199|147511811|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Cochran-Mantel-Haenszel|||||||0.0011
73983042|NCT00472199|147511812|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.0489||95.0|-1.1|-0.9|||Wilcoxon (Mann-Whitney)|||||-0.9|-1.1|0.0489
73983043|NCT00472199|147511813|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0315|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0315
73983044|NCT00472199|147511814|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0735|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0735
73983045|NCT00472199|147511815|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.841|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.8410
73983046|NCT00472199|147511816|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.9241|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.9241
73983047|NCT00472199|147511817|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8093|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.8093
73983048|NCT00472199|147511818|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0583|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0583
73983049|NCT00472199|147511819|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.0||||0.0916|TWO_SIDED|95.0|-5.5|-4.5|||Wilcoxon (Mann-Whitney)|||||-4.5|-5.5|0.0916
73983050|NCT00472199|147511820|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.5905|TWO_SIDED|95.0|2.2|2.8|||Wilcoxon (Mann-Whitney)|||||2.8|2.2|0.5905
73983051|NCT00472199|147511821|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0||||0.0179|TWO_SIDED|95.0|1.6|2.4|||Wilcoxon (Mann-Whitney)|||||2.4|1.6|0.0179
73983052|NCT00472199|147511822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0||||0.545|TWO_SIDED|95.0|1.7|2.3|||Wilcoxon (Mann-Whitney)|||||2.3|1.7|0.5450
73983053|NCT00472199|147511823|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1456|TWO_SIDED|95.0|-0.3|0.3|||Wilcoxon (Mann-Whitney)|||||0.3|-0.3|0.1456
73983054|NCT00472199|147511824|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2915|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.2915
73983055|NCT00472199|147511825|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3131|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.3131
73983056|NCT00472199|147511826|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5713|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.5713
73983057|NCT00472199|147511827|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8432|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.8432
73983058|NCT00472199|147511828|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.3||||0.0206|TWO_SIDED|95.0|5.9|6.6|||Wilcoxon (Mann-Whitney)|||||6.6|5.9|0.0206
73983059|NCT00472199|147511829|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.5602|TWO_SIDED|95.0|0.4|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|0.4|0.5602
73983060|NCT00472199|147511830|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.136|TWO_SIDED|95.0|0.8|1.1|||Wilcoxon (Mann-Whitney)|||||1.1|0.8|0.1360
73983061|NCT00472199|147511832|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Mantel Haenszel|||||||0.0022
73983062|NCT01014013|147511849|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint was based on the proportion of patients who had a favorable microbiological response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-0.8|STANDARD_DEVIATION|10.9||||95.0|-11.7|10.2||||||||10.2|-11.7|
73983063|NCT01014013|147511851|NON_INFERIORITY_OR_EQUIVALENCE|The secondary efficacy endpoint was based on the proportion of patients who had a favorable clinical response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-1.7|STANDARD_ERROR_OF_MEAN|4.9||||95.0|-6.6|3.2||||||||3.2|-6.6|
73983064|NCT02100189|147511866|SUPERIORITY_OR_OTHER||Sensitivity|13.3|STANDARD_ERROR_OF_MEAN|0.062|||TWO_SIDED|95.0|3.76|30.72|||Sensitivity||Exact Binomial confidence interval.|||30.72|3.76|
73983065|NCT02100189|147511867|SUPERIORITY_OR_OTHER||Specificity|94.7|STANDARD_ERROR_OF_MEAN|0.051|||TWO_SIDED|95.0|73.97|99.87|||Specificity||Exact binomial confidence interval|||99.87|73.97|
73983066|NCT02213458|147511870|SUPERIORITY||Slope|0.539||||0.04|TWO_SIDED|95.0|0.259|1.337|||Mixed Models Analysis|Controlling for dementia severity (QDRS)||Linear mixed effects model||1.337|.259|0.04
73983067|NCT02213458|147511871|SUPERIORITY||Slope|-0.138||||0.05|TWO_SIDED|95.0|-0.295|-0.02|||Mixed Models Analysis|Linear mixed model controlling for dementia severity (QDRS)||||-.020|-.295|.05
73983068|NCT02213458|147511872|SUPERIORITY||Slope|-1.902||||0.07|TWO_SIDED|95.0|-3.885|-0.08|||Mixed Models Analysis|Linear mixed model controlling for dementia severity (QDRS)||||-0.080|-3.885|0.07
73983069|NCT02213458|147511874|SUPERIORITY||Slope|-1.143||||0.03|TWO_SIDED|95.0|-2.154|-0.132|||Mixed Models Analysis|||||-0.132|-2.154|0.03
73983070|NCT02213458|147511875|SUPERIORITY||Slope|0.635||||0.11|TWO_SIDED|95.0|-0.135|1.405|||Mixed Models Analysis|Controlling for dementia severity (QDRS)||||1.405|-0.135|0.11
73983071|NCT01075815|147511878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0235||||0.8762|TWO_SIDED|95.0|-0.1546|0.1568|||Wilcoxon two sample test|||||0.1568|-0.1546|0.8762
73983072|NCT01075815|147511879|SUPERIORITY_OR_OTHER|||||||0.3589||95.0|||||ANOVA|||||||0.3589
73983073|NCT01075815|147511880|SUPERIORITY_OR_OTHER|||||||0.0629||95.0|||||Wilcoxon two sample test|||||||0.0629
73983074|NCT01075815|147511881|SUPERIORITY_OR_OTHER|||||||0.4728||95.0|||||ANOVA|||||||0.4728
73983075|NCT01075815|147511882|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Fisher Exact|||||||0.0950
73983076|NCT01075815|147511884|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9625||||0.9179|TWO_SIDED|95.0|0.4655|1.99|||Chi-squared|||||1.9900|0.4655|0.9179
73983077|NCT01075815|147511885|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.875||||0.7271|TWO_SIDED|95.0|0.4133|1.8524|||Chi-squared|||||1.8524|0.4133|0.7271
73983078|NCT01075815|147511886|SUPERIORITY_OR_OTHER|||||||0.3267||95.0|||||Wilcoxon two sample test|||||||0.3267
73983079|NCT01075815|147511887|SUPERIORITY_OR_OTHER|||||||0.4164||95.0|||||Wilcoxon two sample test|||||||0.4164
73983080|NCT01075815|147511888|SUPERIORITY_OR_OTHER|||||||0.5952||95.0|||||Wilcoxon two sample test|||||||0.5952
73983081|NCT01075815|147511890|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9444||||0.8852|TWO_SIDED|95.0|0.4347|2.0518|||Chi-squared|||||2.0518|0.4347|0.8852
73983082|NCT03005106|147511912|OTHER|Difference between treatment and control sites|Mean Difference (Final Values)|97.77|||<|0.0001|TWO_SIDED|||||Difference is (percent area of Autograft treatment site requiring autografting by Month 3) - (percent area of StrataGraft treatment site requiring autografting by Month 3).|one-sided Wilcoxin Signed RankTtest|||||||<0.0001
73983083|NCT03005106|147511913|OTHER||Percentage of participants|83.1|||||TWO_SIDED|95.0|74.4|91.8|||||95% confidence interval is derived using the normal approximation to the binomial distribution|||91.8|74.4|
74033861|NCT01219959|147620694|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
73983084|NCT03005106|147511914|OTHER|Difference is Autograft - StrataGraft|Mean Difference (Final Values)|2.4|||<|0.0001|TWO_SIDED||||||1-sided, paired t-test|p-value from 1-sided, paired t-test on the mean difference(Autograft - StrataGraft)||||||<0.0001
73983085|NCT03005106|147511915|OTHER|Difference is Autograft - StrataGraft|Mean Difference (Final Values)|10.0|||<|0.0001|TWO_SIDED|||||Missing total score data were imputed using a multiple imputation analysis assuming a monotone missing data pattern. A linear regression model with ethnicity, race and age as predictive variables was used in the imputation.|1-sided, paired t-test|p-value from 1-sided, paired t-test on the difference (Autograft - StrataGraft)||||||<0.0001
73983086|NCT03163472|147511916|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73983087|NCT03163472|147511917|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73983088|NCT03163472|147511918|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
73983089|NCT03163472|147511919|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
73983090|NCT00936065|147511922|SUPERIORITY_OR_OTHER|||||||0.0672|TWO_SIDED||||||Fisher Exact|||Overall treatment difference||||0.0672
73983091|NCT00936065|147511923|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 2||||1.0000
73983092|NCT00936065|147511923|SUPERIORITY_OR_OTHER|||||||0.0229|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 4||||0.0229
73983093|NCT00936065|147511923|SUPERIORITY_OR_OTHER|||||||0.0256|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 8||||0.0256
73983094|NCT00936065|147511923|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 12||||0.0004
73983095|NCT00936065|147511923|SUPERIORITY_OR_OTHER|||||||0.0105|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 18||||0.0105
73983096|NCT00936065|147511923|SUPERIORITY_OR_OTHER|||||||0.0366|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 24||||0.0366
73983097|NCT00936065|147511924|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||1.0000
73983098|NCT00936065|147511924|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.3230
73983099|NCT00936065|147511924|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||1.0000
73983100|NCT00936065|147511924|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||1.0000
73983101|NCT00936065|147511925|SUPERIORITY_OR_OTHER|||||||0.3103|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.3103
73983102|NCT00936065|147511925|SUPERIORITY_OR_OTHER|||||||0.4763|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.4763
73983103|NCT00936065|147511925|SUPERIORITY_OR_OTHER|||||||0.1961|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1961
73983104|NCT00936065|147511925|SUPERIORITY_OR_OTHER|||||||0.0272|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0272
73983105|NCT00936065|147511925|SUPERIORITY_OR_OTHER|||||||0.5038|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.5038
73983106|NCT00936065|147511925|SUPERIORITY_OR_OTHER|||||||0.0374|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0374
73983107|NCT00936065|147511926|SUPERIORITY_OR_OTHER|||||||0.6061|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.6061
73983108|NCT00936065|147511926|SUPERIORITY_OR_OTHER|||||||0.2971|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.2971
73983109|NCT00936065|147511926|SUPERIORITY_OR_OTHER|||||||0.1119|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.1119
73983110|NCT00936065|147511926|SUPERIORITY_OR_OTHER|||||||0.1081|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1081
73983111|NCT00936065|147511926|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0063
73983112|NCT00936065|147511926|SUPERIORITY_OR_OTHER|||||||0.0055|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.0055
73983113|NCT00936065|147511926|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0031
73983114|NCT00936065|147511927|SUPERIORITY_OR_OTHER|||||||0.0033|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0033
73983115|NCT00936065|147511928|SUPERIORITY_OR_OTHER|||||||0.0448|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0448
73983116|NCT00936065|147511929|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0041
73983117|NCT00936065|147511930|SUPERIORITY_OR_OTHER|||||||0.3536|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.3536
73983118|NCT00936065|147511931|SUPERIORITY_OR_OTHER|||||||0.0203|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.0203
73983119|NCT00936065|147511931|SUPERIORITY_OR_OTHER|||||||0.0102|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0102
73983120|NCT00936065|147511931|SUPERIORITY_OR_OTHER|||||||0.0056|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0056
73983121|NCT00936065|147511931|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0006
73983122|NCT00936065|147511931|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0066
73983123|NCT00936065|147511931|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0058
73983124|NCT00936065|147511932|SUPERIORITY_OR_OTHER|||||||0.0329|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.0329
73983125|NCT00936065|147511932|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0003
73983126|NCT00936065|147511932|SUPERIORITY_OR_OTHER|||||||0.0598|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0598
73983127|NCT00936065|147511932|SUPERIORITY_OR_OTHER|||||||0.0241|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0241
73983128|NCT00936065|147511932|SUPERIORITY_OR_OTHER|||||||0.0543|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0543
73983129|NCT00936065|147511932|SUPERIORITY_OR_OTHER|||||||0.1205|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.1205
73983130|NCT00936065|147511933|SUPERIORITY_OR_OTHER|||||||0.1385|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1385
73983131|NCT00936065|147511933|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0019
73983132|NCT00936065|147511933|SUPERIORITY_OR_OTHER|||||||0.0442|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0442
73983133|NCT00936065|147511933|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0034
73983134|NCT00936065|147511933|SUPERIORITY_OR_OTHER|||||||0.0454|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0454
73983135|NCT00936065|147511933|SUPERIORITY_OR_OTHER|||||||0.0539|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0539
73983136|NCT00936065|147511934|SUPERIORITY_OR_OTHER|||||||0.1723|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1723
73983137|NCT00936065|147511934|SUPERIORITY_OR_OTHER|||||||0.0292|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0292
73983138|NCT00936065|147511934|SUPERIORITY_OR_OTHER|||||||0.0908|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0908
73983139|NCT00936065|147511934|SUPERIORITY_OR_OTHER|||||||0.5678|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.5678
73983140|NCT00936065|147511934|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.4820
73983141|NCT00936065|147511934|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0394
73983142|NCT00936065|147511935|SUPERIORITY_OR_OTHER|||||||0.1079|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1079
73983143|NCT00936065|147511935|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0004
73983144|NCT00936065|147511935|SUPERIORITY_OR_OTHER|||||||0.0146|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0146
73983145|NCT00936065|147511935|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0019
73983146|NCT00936065|147511935|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0062
73983147|NCT00936065|147511935|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0197
73983148|NCT00936065|147511936|SUPERIORITY_OR_OTHER|||||||0.1229|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1229
73983149|NCT00936065|147511936|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0136
73983150|NCT00936065|147511936|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.1578
73983151|NCT00936065|147511936|SUPERIORITY_OR_OTHER|||||||0.0565|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0565
73983152|NCT00936065|147511936|SUPERIORITY_OR_OTHER|||||||0.0685|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0685
73983153|NCT00936065|147511936|SUPERIORITY_OR_OTHER|||||||0.0493|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0493
73983154|NCT00936065|147511937|SUPERIORITY_OR_OTHER|||||||0.3112|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3112
73983155|NCT00936065|147511937|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0196
73983156|NCT00936065|147511937|SUPERIORITY_OR_OTHER|||||||0.0109|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0109
73983157|NCT00936065|147511937|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0035
73983158|NCT00936065|147511937|SUPERIORITY_OR_OTHER|||||||0.0603|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0603
73983159|NCT00936065|147511937|SUPERIORITY_OR_OTHER|||||||0.2184|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.2184
73983160|NCT00936065|147511938|SUPERIORITY_OR_OTHER|||||||0.1774|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.1774
73983161|NCT00936065|147511938|SUPERIORITY_OR_OTHER|||||||0.1195|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1195
73983162|NCT00936065|147511938|SUPERIORITY_OR_OTHER|||||||0.0606|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0606
73983163|NCT00936065|147511938|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0030
73983164|NCT00936065|147511938|SUPERIORITY_OR_OTHER|||||||0.1567|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1567
73983165|NCT00936065|147511938|SUPERIORITY_OR_OTHER|||||||0.2094|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.2094
73983166|NCT00936065|147511939|SUPERIORITY_OR_OTHER|||||||0.0302|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0302
73983167|NCT00936065|147511939|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0980
73983168|NCT00936065|147511939|SUPERIORITY_OR_OTHER|||||||0.0711|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0711
73983169|NCT00936065|147511939|SUPERIORITY_OR_OTHER|||||||0.0077|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0077
73983170|NCT00936065|147511939|SUPERIORITY_OR_OTHER|||||||0.1553|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1553
73983171|NCT00936065|147511939|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0410
73983172|NCT00936065|147511940|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0060
73983173|NCT00936065|147511940|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0058
74033862|NCT01219959|147620695|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
74033863|NCT01219959|147620696|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
73983174|NCT00936065|147511940|SUPERIORITY_OR_OTHER|||||||0.0127|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0127
73983175|NCT00936065|147511940|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0068
73983176|NCT00936065|147511940|SUPERIORITY_OR_OTHER|||||||0.0096|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0096
73983177|NCT00936065|147511940|SUPERIORITY_OR_OTHER|||||||0.0132|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0132
73983178|NCT00936065|147511941|SUPERIORITY_OR_OTHER|||||||0.6904|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.6904
73983179|NCT00936065|147511941|SUPERIORITY_OR_OTHER|||||||0.7021|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.7021
73983180|NCT00936065|147511941|SUPERIORITY_OR_OTHER|||||||0.2199|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.2199
73983181|NCT00936065|147511941|SUPERIORITY_OR_OTHER|||||||0.5071|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.5071
73983182|NCT00936065|147511941|SUPERIORITY_OR_OTHER|||||||0.4765|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.4765
73983183|NCT00936065|147511941|SUPERIORITY_OR_OTHER|||||||0.8662|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.8662
73983184|NCT00936065|147511942|SUPERIORITY_OR_OTHER|||||||0.1144|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.1144
73983185|NCT00936065|147511942|SUPERIORITY_OR_OTHER|||||||0.4509|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4509
73983186|NCT00936065|147511942|SUPERIORITY_OR_OTHER|||||||0.435|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4350
73983187|NCT00936065|147511942|SUPERIORITY_OR_OTHER|||||||0.6085|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.6085
73983188|NCT00936065|147511942|SUPERIORITY_OR_OTHER|||||||0.2582|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2582
73983189|NCT00936065|147511942|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.5490
73983190|NCT00936065|147511943|SUPERIORITY_OR_OTHER|||||||0.3287|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3287
73983191|NCT00936065|147511943|SUPERIORITY_OR_OTHER|||||||0.4149|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4149
73983192|NCT00936065|147511943|SUPERIORITY_OR_OTHER|||||||0.3837|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.3837
73983193|NCT00936065|147511943|SUPERIORITY_OR_OTHER|||||||0.6777|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.6777
73983194|NCT00936065|147511943|SUPERIORITY_OR_OTHER|||||||0.4976|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.4976
73983195|NCT00936065|147511943|SUPERIORITY_OR_OTHER|||||||0.4189|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.4189
73983196|NCT00936065|147511944|SUPERIORITY_OR_OTHER|||||||0.476|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.4760
73983197|NCT00936065|147511944|SUPERIORITY_OR_OTHER|||||||0.404|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4040
73983198|NCT00936065|147511944|SUPERIORITY_OR_OTHER|||||||0.4753|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4753
73983199|NCT00936065|147511944|SUPERIORITY_OR_OTHER|||||||0.5084|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.5084
73983200|NCT00936065|147511944|SUPERIORITY_OR_OTHER|||||||0.2293|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2293
73983201|NCT00936065|147511944|SUPERIORITY_OR_OTHER|||||||0.3822|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3822
73983202|NCT00936065|147511945|SUPERIORITY_OR_OTHER|||||||0.2691|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.2691
73983203|NCT00936065|147511945|SUPERIORITY_OR_OTHER|||||||0.0142|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0142
74033864|NCT01219959|147620696|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
74033865|NCT01219959|147620696|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
73983204|NCT00936065|147511945|SUPERIORITY_OR_OTHER|||||||0.0383|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0383
73983205|NCT00936065|147511945|SUPERIORITY_OR_OTHER|||||||0.0026|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0026
73983206|NCT00936065|147511945|SUPERIORITY_OR_OTHER|||||||0.0475|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0475
73983207|NCT00936065|147511945|SUPERIORITY_OR_OTHER|||||||0.0205|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0205
73983208|NCT00936065|147511946|SUPERIORITY_OR_OTHER|||||||0.0512|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0512
73983209|NCT00936065|147511946|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0024
73983210|NCT00936065|147511946|SUPERIORITY_OR_OTHER|||||||0.0946|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0946
74033866|NCT01219959|147620696|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
74033867|NCT01219959|147620697|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
74033868|NCT01219959|147620697|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
74033869|NCT01219959|147620697|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
74033870|NCT01219959|147620697|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
74033871|NCT01219959|147620698|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
74033872|NCT01219959|147620698|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
74033873|NCT01219959|147620699|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
74033874|NCT01219959|147620699|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
73983211|NCT00936065|147511946|SUPERIORITY_OR_OTHER|||||||0.0935|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0935
73983212|NCT00936065|147511946|SUPERIORITY_OR_OTHER|||||||0.2073|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2073
73983213|NCT00936065|147511946|SUPERIORITY_OR_OTHER|||||||0.3415|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3415
73983214|NCT00936065|147511947|SUPERIORITY_OR_OTHER|||||||0.0202|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0202
73983215|NCT00936065|147511947|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0090
73983216|NCT00936065|147511947|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0742
73983217|NCT00936065|147511947|SUPERIORITY_OR_OTHER|||||||0.0445|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0445
73983218|NCT00936065|147511947|SUPERIORITY_OR_OTHER|||||||0.2211|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2211
73983219|NCT00936065|147511947|SUPERIORITY_OR_OTHER|||||||0.1982|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.1982
73983220|NCT00936065|147511948|SUPERIORITY_OR_OTHER|||||||0.0409|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0409
73983221|NCT00936065|147511948|SUPERIORITY_OR_OTHER|||||||0.145|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1450
73983222|NCT00936065|147511948|SUPERIORITY_OR_OTHER|||||||0.201|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.2010
73983223|NCT00936065|147511948|SUPERIORITY_OR_OTHER|||||||0.0424|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0424
73983224|NCT00936065|147511948|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0090
73983225|NCT00936065|147511948|SUPERIORITY_OR_OTHER|||||||0.0116|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0116
73983226|NCT00936065|147511949|SUPERIORITY_OR_OTHER|||||||0.3355|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3355
73983227|NCT00936065|147511949|SUPERIORITY_OR_OTHER|||||||0.0341|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0341
73983228|NCT00936065|147511949|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0899
73983229|NCT00936065|147511949|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0062
73983230|NCT00936065|147511949|SUPERIORITY_OR_OTHER|||||||0.1241|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1241
73983231|NCT00936065|147511949|SUPERIORITY_OR_OTHER|||||||0.0393|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0393
74033875|NCT01219959|147620700|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
74033876|NCT01219959|147620700|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
74033877|NCT01219959|147620701|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
74033878|NCT01219959|147620702|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
74033879|NCT01219959|147620702|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
73983232|NCT00936065|147511950|SUPERIORITY_OR_OTHER|||||||0.3402|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3402
73983233|NCT00936065|147511950|SUPERIORITY_OR_OTHER|||||||0.1184|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1184
73983234|NCT00936065|147511950|SUPERIORITY_OR_OTHER|||||||0.0104|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0104
73983235|NCT00936065|147511950|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0010
73983236|NCT00936065|147511950|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0250
73983237|NCT00936065|147511950|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0410
73983238|NCT00936065|147511951|SUPERIORITY_OR_OTHER|||||||0.0894|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0894
73983239|NCT00936065|147511951|SUPERIORITY_OR_OTHER|||||||0.0084|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0084
73983240|NCT00936065|147511951|SUPERIORITY_OR_OTHER|||||||0.0727|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0727
73983241|NCT00936065|147511951|SUPERIORITY_OR_OTHER|||||||0.0337|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0337
73983242|NCT00936065|147511951|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1380
73983243|NCT00936065|147511951|SUPERIORITY_OR_OTHER|||||||0.3415|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3415
73983244|NCT00936065|147511952|SUPERIORITY_OR_OTHER|||||||0.4407|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.4407
73983245|NCT00936065|147511952|SUPERIORITY_OR_OTHER|||||||0.1768|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1768
73983246|NCT00936065|147511952|SUPERIORITY_OR_OTHER|||||||0.4636|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4636
73983247|NCT00936065|147511952|SUPERIORITY_OR_OTHER|||||||0.334|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.3340
73983248|NCT00936065|147511952|SUPERIORITY_OR_OTHER|||||||0.1785|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1785
73983249|NCT00936065|147511952|SUPERIORITY_OR_OTHER|||||||0.7428|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.7428
73983250|NCT00936065|147511953|SUPERIORITY_OR_OTHER|||||||0.5377|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.5377
73983251|NCT00936065|147511953|SUPERIORITY_OR_OTHER|||||||0.1419|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.1419
73983252|NCT00936065|147511953|SUPERIORITY_OR_OTHER|||||||0.5391|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.5391
73983253|NCT00936065|147511953|SUPERIORITY_OR_OTHER|||||||0.2589|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.2589
73983254|NCT00936065|147511953|SUPERIORITY_OR_OTHER|||||||0.0635|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0635
73983255|NCT00936065|147511953|SUPERIORITY_OR_OTHER|||||||0.1172|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.1172
73983256|NCT00936065|147511953|SUPERIORITY_OR_OTHER|||||||0.1247|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.1247
73983257|NCT00936065|147511954|SUPERIORITY_OR_OTHER|||||||0.9429|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.9429
73983258|NCT00936065|147511954|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.0927
73983259|NCT00936065|147511954|SUPERIORITY_OR_OTHER|||||||0.0151|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.0151
73983260|NCT00936065|147511954|SUPERIORITY_OR_OTHER|||||||0.1124|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1124
73983261|NCT00936065|147511954|SUPERIORITY_OR_OTHER|||||||0.0242|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0242
74033880|NCT01219959|147620702|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
73983262|NCT00936065|147511954|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.0237
73983263|NCT00936065|147511954|SUPERIORITY_OR_OTHER|||||||0.0176|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0176
73983264|NCT00145496|147511955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7177||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in NSA Scale total score between asenapine and olanzapine at Day 182.||||0.7177
73983265|NCT00145496|147511956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0565||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in QLS total score between asenapine and olanzapine at Day 182.||||0.0565
73983266|NCT00145496|147511957|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in body weight between asenapine and olanzapine at Day 182.||||<0.0001
73983267|NCT02680145|147511966|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.001
73983268|NCT02680145|147511967|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.001
73983269|NCT02680145|147511968|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.005
73983270|NCT01542502|147511969|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
73983271|NCT01542502|147511970|SUPERIORITY_OR_OTHER|||||||0.87|||||||ANOVA|||||||0.87
73983272|NCT01052714|147511976|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73983273|NCT01052714|147511977|SUPERIORITY|||||||0.718|||||||Mixed Models Analysis|||||||0.718
73983274|NCT01052714|147511978|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73983275|NCT01052714|147511979|SUPERIORITY|||||||0.676|||||||Mixed Models Analysis|||||||0.676
73983276|NCT01052714|147511980|SUPERIORITY|||||||0.141|||||||Mixed Models Analysis|||||||0.141
73983277|NCT01052714|147511981|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
73983278|NCT01052714|147511982|SUPERIORITY|||||||0.322|||||||Mixed Models Analysis|||||||0.322
73983279|NCT01052714|147511983|SUPERIORITY|||||||0.652|||||||Mixed Models Analysis|||||||0.652
73983280|NCT01052714|147511984|SUPERIORITY|||||||0.663|||||||Mixed Models Analysis|||||||0.663
73983281|NCT01052714|147511985|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.9
73983282|NCT01052714|147511986|SUPERIORITY|||||||0.415|||||||Mixed Models Analysis|||||||0.415
73983283|NCT01052714|147511987|SUPERIORITY|||||||0.687|||||||Mixed Models Analysis|||||||0.687
73983284|NCT01052714|147511988|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
73983285|NCT01052714|147511989|SUPERIORITY|||||||0.059|||||||Mixed Models Analysis|||||||0.059
73983286|NCT01052714|147511990|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
74033881|NCT01219959|147620702|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
74033882|NCT01219959|147620703|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
74033883|NCT01219959|147620703|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
74033884|NCT01219959|147620704|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
74033885|NCT01219959|147620704|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
74033886|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
74033887|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
74033888|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
73983287|NCT01052714|147511991|SUPERIORITY|||||||0.146|||||||Mixed Models Analysis|||||||0.146
74033889|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
74033890|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
74033891|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
74033892|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
74033893|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
73983288|NCT01052714|147511992|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73983289|NCT01052714|147511993|SUPERIORITY|||||||0.763|||||||Mixed Models Analysis|||||||0.763
73983290|NCT02168855|147511994|SUPERIORITY||Odds Ratio (OR)|1.39||||0.46|TWO_SIDED|95.0|0.58|3.29|||Regression, Logistic|This is a logistic regression model of the active versus placebo arm, while controlling for age and cigarettes smoked per day at enrollment.|The active arm is the numerator and the placebo arm is the denominator of the odds ratio|||3.29|0.58|0.46
73983291|NCT02168855|147511995|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.0001|TWO_SIDED|95.0|1.83|1.98|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in craving. Temptations are the numerator and background is the denominator.|||1.98|1.83|<0.0001
73983292|NCT02168855|147511996|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.0001|TWO_SIDED|95.0|1.51|1.83|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in negative affect T-score. Temptations are the numerator and background is the denominator.|||1.83|1.51|<0.0001
73983293|NCT02168855|147511997|SUPERIORITY||Odds Ratio (OR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.14|0.21|||Regression, Logistic|Includes random subject intercept effect|Odds ratio where temptations are the numerator and background is the denominator, that no smoking cues were seen.|||0.21|0.14|<0.0001
73983294|NCT02168855|147511998|SUPERIORITY||Odds Ratio (OR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.15|0.23|||Regression, Logistic||Odds ratio where temptations are the numerator and background is the denominator, that no other people were seen smoking nearby.|||0.23|0.15|<0.0001
73983295|NCT03000829|147512034|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
73983296|NCT03000829|147512035|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
73983297|NCT03000829|147512036|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
73983298|NCT03000829|147512037|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
73983299|NCT03000829|147512038|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
73983300|NCT03000829|147512039|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
73983301|NCT03000829|147512040|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
73983302|NCT03000829|147512041|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
73983303|NCT03000829|147512044|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
73983304|NCT06466655|147512061|EQUIVALENCE||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73983305|NCT06466655|147512062|EQUIVALENCE||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73983306|NCT00635609|147512098|SUPERIORITY_OR_OTHER|||||||0.765||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.765
73983307|NCT00635609|147512099|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.290
73983308|NCT00635609|147512100|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.033
73983309|NCT04448561|147512119|OTHER||Geometric Least square (LS) mean ratio|100.64|||||TWO_SIDED|90.0|98.37|102.96|||||Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.|||102.96|98.37|
73983310|NCT04448561|147512120|OTHER||Geometric LS mean ratio|94.28|||||TWO_SIDED|90.0|89.29|99.54|||||Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.|||99.54|89.29|
73983311|NCT04448561|147512122|OTHER||Geometric LS mean ratio|100.79|||||TWO_SIDED|90.0|83.35|121.88|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||121.88|83.35|
73983312|NCT04448561|147512123|OTHER||Geometric LS mean ratio|100.58|||||TWO_SIDED|90.0|81.35|124.36|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||124.36|81.35|
73983313|NCT04448561|147512125|OTHER||Geometric LS mean ratio|89.08|||||TWO_SIDED|90.0|79.58|99.71|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||99.71|79.58|
73983314|NCT04448561|147512126|OTHER||Geometric LS mean ratio|96.11|||||TWO_SIDED|90.0|83.03|111.25|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.|||111.25|83.03|
73983315|NCT04448561|147512128|OTHER||Geometric LS mean ratio|86.54|||||TWO_SIDED|90.0|76.01|98.52|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.|||98.52|76.01|
73983316|NCT04448561|147512129|OTHER||Geometric LS mean ratio|95.1|||||TWO_SIDED|90.0|82.52|109.6|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||109.60|82.52|
73983317|NCT03694210|147512156|SUPERIORITY||Mean Difference (Net)|0.0||||0.0011|TWO_SIDED|||||p-values of \<0.05 are considered significant.|Wilcoxon Signed Rank Test|||Physical Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0011
73983318|NCT03694210|147512156|SUPERIORITY||Mean Difference (Net)|0.0||||0.1152|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Role Limitations due to Physical Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.1152
73983319|NCT03694210|147512156|SUPERIORITY||Mean Difference (Net)|0.0||||0.0552|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Role Limitations due to Emotional Problems: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0552
73983320|NCT03694210|147512156|SUPERIORITY||Mean Difference (Net)|0.0||||0.039|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Energy/Fatigue: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.039
73983321|NCT03694210|147512156|SUPERIORITY||Mean Difference (Net)|0.0||||0.0223|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Emotional Well Being: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0223
73983322|NCT03694210|147512156|SUPERIORITY||Mean Difference (Net)|0.0||||0.4664|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Social Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.4664
73983323|NCT03694210|147512156|SUPERIORITY||Mean Difference (Net)|0.0||||0.0001|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Pain: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0001
73983324|NCT03694210|147512156|SUPERIORITY||Mean Difference (Net)|0.0||||0.0639|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||General Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0639
73983325|NCT02706834|147512158|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.43|||||TWO_SIDED|90.0|0.38|0.487|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means on the original scale.||0.487|0.380|
73983326|NCT02706834|147512165|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.896|||||TWO_SIDED|90.0|0.833|0.964|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means and ratios of geometric means on the original scale.||0.964|0.833|
74033894|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
74033895|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
73874158|NCT01010971|147290459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.0001|TWO_SIDED|95.0|0.61|1.46||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.46|0.61|<0.0001
73874159|NCT01010971|147290460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|||<|0.0001|TWO_SIDED|95.0|0.07|0.29|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.29|0.07|<0.0001
73874160|NCT01010971|147290460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.0001|TWO_SIDED|95.0|0.08|0.29|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.29|0.08|<0.0001
73874161|NCT01010971|147290461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.1444|TWO_SIDED|95.0|-0.03|0.71||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.71|-0.03|0.1444
73983327|NCT00627523|147512166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|0.82|1.59||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference in the mean change from Baseline after 24 months in height SDS between the Genotropin® and the untreated control groups. The alternative hypothesis was that there was a difference between the treatment groups.||1.59|0.82|<0.001
73983328|NCT00627523|147512167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.81||0.348|TWO_SIDED|95.0|-0.87|2.42||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||2.42|-0.87|0.348
73874162|NCT01010971|147290461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.0124|TWO_SIDED|95.0|0.15|0.89||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.89|0.15|0.0124
73874163|NCT01010971|147290462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.0124|TWO_SIDED|95.0|0.3|0.94||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||||0.94|0.30|0.0124
73874164|NCT01010971|147290462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|||||TWO_SIDED|95.0|0.33|0.95||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||||0.95|0.33|
73874165|NCT01369784|147290533|SUPERIORITY_OR_OTHER|||||||0.812|||||||Fisher Exact|||||||0.812
73983329|NCT00627523|147512168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|0.55|1.23||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||1.23|0.55|<0.001
74009201|NCT00397033|147569180|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.314||95.0|-1.7|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-1.7|0.314
74033896|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
74009202|NCT00397033|147569181|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.071||95.0|-1.8|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.1|-1.8|0.071
74009203|NCT00397033|147569181|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.099||95.0|-1.7|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.1|-1.7|0.099
74009204|NCT00397033|147569183|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-0.9|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.3|-0.9|<0.001
73874166|NCT01369784|147290534|SUPERIORITY_OR_OTHER|||||||0.612|||||||Chi-squared|||||||0.612
73874167|NCT01369784|147290535|SUPERIORITY_OR_OTHER|||||||0.402|||||||Chi-squared|||||||0.402
73874168|NCT01369784|147290536|SUPERIORITY_OR_OTHER|||||||0.557|||||||Chi-squared|||||||0.557
73874169|NCT01369784|147290537|SUPERIORITY_OR_OTHER|||||||0.234|||||||Chi-squared|||||||0.234
73874170|NCT01369784|147290538|SUPERIORITY_OR_OTHER|||||||0.057|||||||Fisher Exact|||||||0.057
73874171|NCT01369784|147290539|SUPERIORITY_OR_OTHER|||||||0.117|||||||Fisher Exact|||||||0.117
73874172|NCT02905266|147290543|SUPERIORITY||Percent Difference in incidence rates|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Fixed Ratio Combination over Sequential Combination|||0.0|0.0|
73874173|NCT02905266|147290551|SUPERIORITY||Percent Difference of ORRs|-7.5|||||TWO_SIDED|95.0|-26.1|11.0|||||Cochran-Mantel-Haenszel (CMH) method of weighting|||11.0|-26.1|
73874174|NCT02905266|147290551|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.35|1.58||||||||1.58|0.35|
73874175|NCT02905266|147290552|SUPERIORITY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.78|2.37|||||Stratified Cox proportional hazard model|||2.37|0.78|
73874176|NCT02905266|147290553|SUPERIORITY||Cochran-Mantel-Haenszel Odds Ratio|0.87|||||TWO_SIDED|95.0|0.3|2.49|||||Fixed Ratio Combination over Sequential Combination|||2.49|0.30|
73983330|NCT00627523|147512169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|1.63|4.85||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||4.85|1.63|<0.001
73983331|NCT00627523|147512170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|7.19||0.738|TWO_SIDED|95.0|-12.27|17.12||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||17.12|-12.27|0.738
73983332|NCT00627523|147512171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51|STANDARD_ERROR_OF_MEAN|4.27||0.301|TWO_SIDED|95.0|-13.27|4.26||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||4.26|-13.27|0.301
73983333|NCT05030467|147512176|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.39|0.31||||||We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors||0.31|-0.39|
73983334|NCT05030467|147512177|SUPERIORITY||Risk Ratio (RR)|1.02||||0.011|TWO_SIDED|95.0|1.0|1.03|||Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and Poisson-distributed errors, adjusting for clinic-level clustering.||1.03|1.00|0.011
73983335|NCT05030467|147512180|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.383|TWO_SIDED|95.0|-0.38|0.15|||Regression, Linear|||We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors||0.15|-0.38|0.383
73983336|NCT02169089|147512215|SUPERIORITY||Median Difference (Final Values)|-7.78||||0.0293|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0293
73983337|NCT02169089|147512216|SUPERIORITY||Median Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -3.5 and 2.1 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||<0.0001
73983338|NCT02169089|147512217|SUPERIORITY||Median Difference (Final Values)|-40.7||||0.0189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -10.3 and 17.1 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||0.0189
73983339|NCT02169089|147512218|SUPERIORITY||Median Difference (Final Values)|-7.5||||0.1276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -5.95 and 2 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||0.1276
73874177|NCT02905266|147290553|SUPERIORITY||Percent difference in incidence rates|-1.9|||||TWO_SIDED|95.0|-16.0|12.2|||||Fixed Ratio Combination over Sequential Combination|||12.2|-16.0|
73983340|NCT03320941|147512226|OTHER|Dose Finding|Mean Difference (Net)|-1.99|||||TWO_SIDED|95.0|-2.92|-0.21||||||||-0.21|-2.92|
73983341|NCT03320941|147512226|OTHER|Dose Finding|Mean Difference (Net)|-3.0|||||TWO_SIDED|95.0|-4.15|-1.7||||||||-1.70|-4.15|
73983342|NCT03320941|147512226|OTHER|Dose Finding|Mean Difference (Net)|-3.54|||||TWO_SIDED|95.0|-4.54|-2.26||||||||-2.26|-4.54|
73983343|NCT03320941|147512226|OTHER|Dose Finding|Mean Difference (Net)|-3.91|||||TWO_SIDED|95.0|-5.01|-2.77||||||||-2.77|-5.01|
73983344|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio (OR)|2.299||||0.39|TWO_SIDED|95.0|0.344|15.35|||Regression, Logistic|||\>= 3% Percent decrease in body weight||15.350|0.344|0.390
73983345|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio (OR)|15.78||||0.002|TWO_SIDED|95.0|2.844|87.552|||Regression, Logistic|||\>= 3% Percent decrease in body weight||87.552|2.844|0.002
73983346|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio (OR)|12.708||||0.002|TWO_SIDED|95.0|2.511|64.32|||Regression, Logistic|||\>= 3% Percent decrease in body weight||64.320|2.511|0.002
73983347|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio (OR)|16.813|||<|0.001|TWO_SIDED|95.0|3.362|84.085|||Regression, Logistic|||\>= 3% Percent decrease in body weight||84.085|3.362|<0.001
73983348|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio (OR)|1.697||||0.727|TWO_SIDED|95.0|0.087|33.006|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||33.006|0.087|0.727
73983349|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio (OR)|28.26||||0.012|TWO_SIDED|95.0|2.066|386.473|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||386.473|2.066|0.012
73983350|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio (OR)|10.333||||0.059|TWO_SIDED|95.0|0.914|116.82|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||116.820|0.914|0.059
73983351|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio (OR)|9.456||||0.062|TWO_SIDED|95.0|0.891|100.292|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||100.292|0.891|0.062
73983352|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio (OR)|3.59||||0.336|TWO_SIDED|95.0|0.265|48.552|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||48.552|0.265|0.336
73983353|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio, log|9.112||||0.075|TWO_SIDED|95.0|0.799|103.872|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||103.872|0.799|0.075
73983354|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio (OR)|29.312||||0.006|TWO_SIDED|95.0|2.665|322.412|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||322.412|2.665|0.006
73874178|NCT02538042|147290563|SUPERIORITY|||||||0.39|||||||ANOVA|||||||0.39
73874179|NCT03884790|147290581|OTHER|Descriptive statistical analysis|||||||||||||||||Descriptive statistical analysis|||
73983355|NCT03320941|147512227|OTHER|Dose Finding|Odds Ratio (OR)|37.949||||0.003|TWO_SIDED|95.0|3.477|414.232|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||414.232|3.477|0.003
73983356|NCT03320941|147512228|OTHER|Dose Finding|Median Difference (Final Values)|-1.84|||||TWO_SIDED|95.0|-3.56|-0.19||||||Dysglycemic||-0.19|-3.56|
73983357|NCT03320941|147512228|OTHER|Dose Finding|Mean Difference (Final Values)|-2.98|||||TWO_SIDED|95.0|-4.56|-1.46||||||Dysglycemic||-1.46|-4.56|
73983358|NCT03320941|147512228|OTHER|Dose Finding|Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-4.71|-1.82||||||Dysglycemic||-1.82|-4.71|
73983359|NCT03320941|147512228|OTHER|Dose Finding|Mean Difference (Final Values)|-3.51|||||TWO_SIDED|95.0|-4.93|-1.74||||||Dysglycemic||-1.74|-4.93|
73983360|NCT03320941|147512228|OTHER|Dose Finding|Mean Difference (Final Values)|-1.96|||||TWO_SIDED|95.0|-3.12|-0.15||||||T2DM||-0.15|-3.12|
73983361|NCT03320941|147512228|OTHER|Dose Finding|Mean Difference (Final Values)|-2.88|||||TWO_SIDED|95.0|-4.37|-0.61||||||T2DM||-0.61|-4.37|
73983362|NCT03320941|147512228|OTHER|Dose Finding|Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-5.2|-1.52||||||T2DM||-1.52|-5.20|
73983363|NCT03320941|147512228|OTHER|Dose Finding|Median Difference (Final Values)|-4.37|||||TWO_SIDED|95.0|-5.93|-2.79||||||T2DM||-2.79|-5.93|
73983364|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.011||0.278|TWO_SIDED|95.0|-3.104|0.9|||ANCOVA|||Overall Study||0.900|-3.104|0.278
73983365|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|1.013||0.216|TWO_SIDED|95.0|-3.265|0.747|||ANCOVA|||Overall Study||0.747|-3.265|0.216
73983366|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.902||0.158|TWO_SIDED|95.0|-3.069|0.504|||ANCOVA|||Overall Study||0.504|-3.069|0.158
73983367|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|0.89||0.053|TWO_SIDED|95.0|-3.401|0.022|||ANCOVA|||Overall Study||0.022|-3.401|0.053
73983368|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|-2.36|STANDARD_ERROR_OF_MEAN|1.534||0.13|TWO_SIDED|95.0|-5.444|0.717|||ANCOVA|||Dysglycemic||0.717|-5.444|0.130
74033897|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
74033898|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
74033899|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
74033900|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
74033901|NCT01219959|147620705|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
74033902|NCT01219959|147620706|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
73983369|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|-4.08|STANDARD_ERROR_OF_MEAN|1.534||0.011|TWO_SIDED|95.0|-7.156|-0.994|||ANCOVA|||Dysglycemic||-0.994|-7.156|0.011
73983370|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|1.325||0.215|TWO_SIDED|95.0|-4.322|0.996|||ANCOVA|||Dysglycemic||0.996|-4.322|0.215
73983371|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|1.346||0.184|TWO_SIDED|95.0|-4.515|0.888|||ANCOVA|||Dysglycemic||0.888|-4.515|0.184
73983372|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|1.292||0.982|TWO_SIDED|95.0|-2.611|2.552|||ANCOVA|||T2DM||2.552|-2.611|0.982
73983373|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.304||0.544|TWO_SIDED|95.0|-1.809|3.401|||ANCOVA|||T2DM||3.401|-1.809|0.544
73983374|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.188||0.552|TWO_SIDED|95.0|-3.084|1.663|||ANCOVA|||T2DM||1.663|-3.084|0.552
73983375|NCT03320941|147512229|OTHER|Dose Finding|Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|1.139||0.143|TWO_SIDED|95.0|-3.964|0.588|||ANCOVA|||T2DM||0.588|-3.964|0.143
73983376|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.206|STANDARD_ERROR_OF_MEAN|0.086||0.018|TWO_SIDED|95.0|-0.376|-0.035|||ANCOVA|||Overall Study||-0.035|-0.376|0.018
74033903|NCT01219959|147620706|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
74033904|NCT01219959|147620707|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
74033905|NCT01219959|147620707|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
74033906|NCT01219959|147620708|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
74033907|NCT01219959|147620708|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
74033908|NCT01219959|147620709|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
74033909|NCT01728584|147620710|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|1.09||||0.026|TWO_SIDED|95.0|0.13|2.04|||ANCOVA|Analysis of covariance (ANCOVA) model included factors depth of NMB, level of pressure, surgeon and body mass index (BMI)|Difference is deep versus standard NMB|Primary hypothesis - deep NMB improves surgeon's overall satisfaction with the surgical conditions compared to standard NMB||2.04|0.13|0.026
73874180|NCT04378270|147290588|OTHER||Mean Difference (Final Values)|2.93|STANDARD_ERROR_OF_MEAN|1.61||0.0796|TWO_SIDED|95.0|-0.3687|6.2287|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% Confidence Interval (CI) of the difference is reported. The P-value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||6.2287|-0.3687|0.0796
73874181|NCT04378270|147290589|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.879||0.0634|TWO_SIDED|95.0|-3.5014|0.1014|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% Confidence Interval (CI) of the difference is reported. The P-value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||0.1014|-3.5014|0.0634
73983377|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.0863||0.002|TWO_SIDED|95.0|-0.447|-0.105|||ANCOVA|||Overall Study||-0.105|-0.447|0.002
73983378|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.287|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|95.0|-0.437|-0.136|||ANCOVA|||Overall Study||-0.136|-0.437|<0.001
73983379|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.338|STANDARD_ERROR_OF_MEAN|0.0747|<|0.001|TWO_SIDED|95.0|-0.486|-0.19|||ANCOVA|||Overall Study||-0.190|-0.486|<0.001
73983380|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.089|STANDARD_ERROR_OF_MEAN|0.0775||0.258|TWO_SIDED|95.0|-0.245|0.067|||ANCOVA|||Dysglycemic||0.067|-0.245|0.258
73983381|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.134|STANDARD_ERROR_OF_MEAN|0.0774||0.088|TWO_SIDED|95.0|-0.29|0.021|||ANCOVA|||Dysglycemic||0.021|-0.290|0.088
74033910|NCT01728584|147620710|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.02|||<|0.001|TWO_SIDED|95.0|-3.99|-2.05|||ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is low versus standard pressure|||-2.05|-3.99|<0.001
74033911|NCT01728584|147620711|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|3.66|||||TWO_SIDED|95.0|2.3|5.02|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||5.02|2.30|
73874182|NCT04378270|147290590|OTHER||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|5.492||0.002|TWO_SIDED|95.0|7.4498|29.9502|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% confidence interval (CI) of the difference is reported. The P value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||29.9502|7.4498|0.0020
73874183|NCT04378270|147290591|OTHER||Mean Difference (Net)|16.67|STANDARD_ERROR_OF_MEAN|4.327||0.0006|TWO_SIDED|95.0|7.8069|25.5331|||t-test, 2 sided|Degrees of freedom (DF)- 28||||25.5331|7.8069|0.0006
73983382|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.0673||0.035|TWO_SIDED|95.0|-0.282|-0.011|||ANCOVA|||Dysglycemic||-0.011|-0.282|0.035
73983383|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.113|STANDARD_ERROR_OF_MEAN|0.0673||0.1|TWO_SIDED|95.0|-0.248|0.022|||ANCOVA|||Dysglycemic||0.022|-0.248|0.100
73983384|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.313|STANDARD_ERROR_OF_MEAN|0.1399||0.029|TWO_SIDED|95.0|-0.592|-0.033|||ANCOVA|||T2DM||-0.033|-0.592|0.029
73983385|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.399|STANDARD_ERROR_OF_MEAN|0.1411||0.006|TWO_SIDED|95.0|-0.681|-0.117|||ANCOVA|||T2DM||-0.117|-0.681|0.006
73983386|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.409|STANDARD_ERROR_OF_MEAN|0.1253||0.002|TWO_SIDED|95.0|-0.66|-0.159|||ANCOVA|||T2DM||-0.159|-0.660|0.002
73983387|NCT03320941|147512230|OTHER|Dose Finding|Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.1217|<|0.001|TWO_SIDED|95.0|-0.769|-0.282|||ANCOVA|||T2DM||-0.282|-0.769|<0.001
73983388|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.2094||0.408|TWO_SIDED|95.0|-0.589|0.241|||ANCOVA|||Overall Study||0.241|-0.589|0.408
73983389|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|-0.505|STANDARD_ERROR_OF_MEAN|0.2115||0.018|TWO_SIDED|95.0|-0.924|-0.087|||ANCOVA|||Overall Study||-0.087|-0.924|0.018
73983390|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|-0.587|STANDARD_ERROR_OF_MEAN|0.1866||0.002|TWO_SIDED|95.0|-0.956|-0.217|||ANCOVA|||Overall Study||-0.217|-0.956|0.002
73983391|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|0.1831|<|0.001|TWO_SIDED|95.0|-1.188|-0.463|||ANCOVA|||Overall Study||-0.463|-1.188|<0.001
73983392|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.2054||0.293|TWO_SIDED|95.0|-0.194|0.631|||ANCOVA|||Dysglycemic||0.631|-0.194|0.293
73983393|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.2068||0.665|TWO_SIDED|95.0|-0.325|0.506|||ANCOVA|||Dysglycemic||0.506|-0.325|0.665
73983394|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.1791||0.803|TWO_SIDED|95.0|-0.405|0.315|||ANCOVA|||Dysglycemic||0.315|-0.405|0.803
73983395|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|-0.256|STANDARD_ERROR_OF_MEAN|0.1787||0.159|TWO_SIDED|95.0|-0.615|0.103|||ANCOVA|||Dysglycemic||0.103|-0.615|0.159
74033912|NCT01728584|147620711|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.44|||||TWO_SIDED|95.0|-1.8|0.91|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||0.91|-1.80|
74033913|NCT01728584|147620711|SUPERIORITY_OR_OTHER||Difference in LS Means|1.96|||||TWO_SIDED|95.0|0.57|3.36|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||3.36|0.57|
74033914|NCT01728584|147620711|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.1|||||TWO_SIDED|95.0|-5.42|-2.78|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||-2.78|-5.42|
73983396|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|-0.527|STANDARD_ERROR_OF_MEAN|0.3249||0.11|TWO_SIDED|95.0|-1.176|0.122|||ANCOVA|||T2DM||0.122|-1.176|0.110
73983397|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|-1.032|STANDARD_ERROR_OF_MEAN|0.3296||0.003|TWO_SIDED|95.0|-1.691|-0.373|||ANCOVA|||T2DM||-0.373|-1.691|0.003
73983398|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|-1.065|STANDARD_ERROR_OF_MEAN|0.2946|<|0.001|TWO_SIDED|95.0|-1.654|-0.476|||ANCOVA|||T2DM||-0.476|-1.654|<0.001
73983399|NCT03320941|147512231|OTHER|Dose Finding|Mean Difference (Final Values)|-1.298|STANDARD_ERROR_OF_MEAN|0.2855|<|0.001|TWO_SIDED|95.0|-1.869|-0.728|||ANCOVA|||T2DM||-0.728|-1.869|<0.001
73983400|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|2.707||0.865|TWO_SIDED|95.0|-4.898|5.822|||ANCOVA|||Overall Study||5.822|-4.898|0.865
73983401|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.765||0.931|TWO_SIDED|95.0|-5.235|5.716|||ANCOVA|||Overall Study||5.716|-5.235|0.931
73983402|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.433||0.682|TWO_SIDED|95.0|-5.817|3.82|||ANCOVA|||Overall Study||3.820|-5.817|0.682
73874184|NCT04378270|147290594|OTHER||Mean pain scale|17.87|STANDARD_DEVIATION|2.39||0.0001|TWO_SIDED|95.0|16.5465|19.1935|||t-test, 2 sided|Degrees of freedom (DF)- 14||This procedure calculates the difference of an observed mean (from the assessment collected at the 4 week visit) with a hypothesized mean value (10, a mid level scale score). A significance value (P-value) and 95% Confidence Interval (CI) of the observed mean is reported. The P-value is the probability of obtaining the observed mean in the sample if the null hypothesis value were the true value.||19.1935|16.5465|0.0001
73983403|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|2.387||0.508|TWO_SIDED|95.0|-6.312|3.142|||ANCOVA|||Overall Study||3.142|-6.312|0.508
73983404|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|4.206||0.757|TWO_SIDED|95.0|-7.138|9.749|||ANCOVA|||Dysglycemic||9.749|-7.138|0.757
73983405|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|4.267||0.999|TWO_SIDED|95.0|-8.571|8.563|||ANCOVA|||Dysglycemic||8.563|-8.571|0.999
73983406|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|3.668||0.342|TWO_SIDED|95.0|-3.848|10.88|||ANCOVA|||Dysglycemic||10.880|-3.848|0.342
73983407|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|2.92|STANDARD_ERROR_OF_MEAN|3.673||0.43|TWO_SIDED|95.0|-4.454|10.292|||ANCOVA|||Dysglycemic||10.292|-4.454|0.430
73983408|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.461||0.909|TWO_SIDED|95.0|-7.312|6.52|||ANCOVA|||T2DM||6.520|-7.312|0.909
73983409|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|3.563||0.821|TWO_SIDED|95.0|-6.311|7.93|||ANCOVA|||T2DM||7.930|-6.311|0.821
73983410|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|-4.87|STANDARD_ERROR_OF_MEAN|3.19||0.132|TWO_SIDED|95.0|-11.24|1.508|||ANCOVA|||T2DM||1.508|-11.240|0.132
73983411|NCT03320941|147512232|OTHER|Dose Finding|Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|3.07||0.093|TWO_SIDED|95.0|-11.367|0.905|||ANCOVA|||T2DM||0.905|-11.367|0.093
73983412|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|2.013||0.769|TWO_SIDED|95.0|-4.579|3.393|||ANCOVA|||Overall Study||3.393|-4.579|0.769
73983413|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.043||0.839|TWO_SIDED|95.0|-4.462|3.63|||ANCOVA|||Overall Study||3.630|-4.462|0.839
73983414|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.807||0.496|TWO_SIDED|95.0|-4.811|2.345|||ANCOVA|||Overall Study||2.345|-4.811|0.496
73983415|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|1.774||0.237|TWO_SIDED|95.0|-5.622|1.402|||ANCOVA|||Overall Study||1.402|-5.622|0.237
73983416|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|3.2||0.758|TWO_SIDED|95.0|-5.435|7.415|||ANCOVA|||Dysglycemic||7.415|-5.435|0.758
73983417|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|3.23||0.978|TWO_SIDED|95.0|-6.574|6.397|||ANCOVA|||Dysglycemic||6.397|-6.574|0.978
73983418|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|2.79||0.512|TWO_SIDED|95.0|-3.758|7.444|||ANCOVA|||Dysglycemic||7.444|-3.758|0.512
73983419|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|2.792||0.985|TWO_SIDED|95.0|-5.552|5.657|||ANCOVA|||Dysglycemic||5.657|-5.552|0.985
73983420|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|2.599||0.428|TWO_SIDED|95.0|-7.268|3.121|||ANCOVA|||T2DM||3.121|-7.268|0.428
73983421|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|2.669||0.846|TWO_SIDED|95.0|-5.853|4.812|||ANCOVA|||T2DM||4.812|-5.853|0.846
73983422|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|-4.05|STANDARD_ERROR_OF_MEAN|2.388||0.095|TWO_SIDED|95.0|-8.825|0.721|||ANCOVA|||T2DM||0.721|-8.825|0.095
73983423|NCT03320941|147512233|OTHER|Dose Finding|Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.31||0.089|TWO_SIDED|95.0|-8.61|0.623|||ANCOVA|||T2DM||0.623|-8.610|0.089
73983424|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|-15.561|STANDARD_ERROR_OF_MEAN|21.4808||0.47|TWO_SIDED|95.0|-58.106|26.985|||ANCOVA|||Overall Study||26.985|-58.106|0.470
73983425|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|-6.343|STANDARD_ERROR_OF_MEAN|21.6316||0.77|TWO_SIDED|95.0|-49.187|36.501|||ANCOVA|||Overall Study||36.501|-49.187|0.770
73983426|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|26.527|STANDARD_ERROR_OF_MEAN|19.1803||0.169|TWO_SIDED|95.0|-11.462|64.516|||ANCOVA|||Overall Study||64.516|-11.462|0.169
73983427|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|-12.094|STANDARD_ERROR_OF_MEAN|18.8076||0.521|TWO_SIDED|95.0|-49.345|25.157|||ANCOVA|||Overall Study||25.157|-49.345|0.521
73983428|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|-22.115|STANDARD_ERROR_OF_MEAN|38.7858||0.571|TWO_SIDED|95.0|-100.058|55.828|||ANCOVA|||Dysglycemic||55.828|-100.058|0.571
73983429|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|-22.948|STANDARD_ERROR_OF_MEAN|39.4994||0.564|TWO_SIDED|95.0|-102.325|56.429|||ANCOVA|||Dysglycemic||56.429|-102.325|0.564
73983430|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|31.322|STANDARD_ERROR_OF_MEAN|33.855||0.359|TWO_SIDED|95.0|-36.712|99.356|||ANCOVA|||Dysglycemic||99.356|-36.712|0.359
73983431|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|-6.901|STANDARD_ERROR_OF_MEAN|34.4309||0.842|TWO_SIDED|95.0|-76.093|62.29|||ANCOVA|||Dysglycemic||62.290|-76.093|0.842
73983432|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|-12.79|STANDARD_ERROR_OF_MEAN|24.3259||0.601|TWO_SIDED|95.0|-61.417|35.836|||ANCOVA|||T2DM||35.836|-61.417|0.601
73983433|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|9.302|STANDARD_ERROR_OF_MEAN|24.422||0.705|TWO_SIDED|95.0|-39.517|58.121|||ANCOVA|||T2DM||58.121|-39.517|0.705
73983434|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|20.94|STANDARD_ERROR_OF_MEAN|22.0444||0.346|TWO_SIDED|95.0|-23.126|65.007|||ANCOVA|||T2DM||65.007|-23.126|0.346
73983435|NCT03320941|147512234|OTHER|Dose Finding|Mean Difference (Final Values)|-13.863|STANDARD_ERROR_OF_MEAN|21.2205||0.516|TWO_SIDED|95.0|-56.283|28.556|||ANCOVA|||T2DM||28.556|-56.283|0.516
73983436|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|0.955|STANDARD_ERROR_OF_MEAN|3.605||0.792|TWO_SIDED|95.0|-6.185|8.095|||ANCOVA|||Overall Study||8.095|-6.185|0.792
73874185|NCT03201419|147290604|SUPERIORITY||Mean Difference|-0.3|||||TWO_SIDED|95.0|-0.54|-0.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.07|-0.54|
73983437|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|-0.739|STANDARD_ERROR_OF_MEAN|3.7167||0.843|TWO_SIDED|95.0|-8.1|6.623|||ANCOVA|||Overall Study||6.623|-8.100|0.843
73983438|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|3.128|STANDARD_ERROR_OF_MEAN|3.2564||0.339|TWO_SIDED|95.0|-3.322|9.578|||ANCOVA|||Overall Study||9.578|-3.322|0.339
73983439|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|2.546|STANDARD_ERROR_OF_MEAN|3.1859||0.426|TWO_SIDED|95.0|-3.764|8.856|||ANCOVA|||Overall Study||8.856|-3.764|0.426
73983440|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|0.504|STANDARD_ERROR_OF_MEAN|5.8734||0.932|TWO_SIDED|95.0|-11.299|12.307|||ANCOVA|||Dysglycemic||12.307|-11.299|0.932
73874186|NCT03201419|147290604|SUPERIORITY||Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.46|-0.02||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.02|-0.46|
73983441|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|-2.458|STANDARD_ERROR_OF_MEAN|6.3493||0.7|TWO_SIDED|95.0|-15.217|10.302|||ANCOVA|||Dysglycemic||10.302|-15.217|0.700
73983442|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|7.832|STANDARD_ERROR_OF_MEAN|5.0946||0.131|TWO_SIDED|95.0|-2.406|18.07|||ANCOVA|||Dysglycemic||18.070|-2.406|0.131
73983443|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|1.825|STANDARD_ERROR_OF_MEAN|5.197||0.727|TWO_SIDED|95.0|-8.619|12.269|||ANCOVA|||Dysglycemic||12.269|-8.619|0.727
73983444|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|0.828|STANDARD_ERROR_OF_MEAN|4.5876||0.857|TWO_SIDED|95.0|-8.342|9.999|||ANCOVA|||T2DM||9.999|-8.342|0.857
73874187|NCT03201419|147290604|SUPERIORITY||Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.36|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.36|
73874188|NCT03201419|147290604|SUPERIORITY||Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.23|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.23|
73983445|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|-0.696|STANDARD_ERROR_OF_MEAN|4.7173||0.883|TWO_SIDED|95.0|-10.126|8.734|||ANCOVA|||T2DM||8.734|-10.126|0.883
73983446|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|-0.975|STANDARD_ERROR_OF_MEAN|4.2883||0.821|TWO_SIDED|95.0|-9.547|7.597|||ANCOVA|||T2DM||7.597|-9.547|0.821
73983447|NCT03320941|147512235|OTHER|Dose Finding|Mean Difference (Final Values)|2.488|STANDARD_ERROR_OF_MEAN|4.1111||0.547|TWO_SIDED|95.0|-5.73|10.706|||ANCOVA|||T2DM||10.706|-5.730|0.547
73983448|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|4.954|STANDARD_ERROR_OF_MEAN|3.4006||0.148|TWO_SIDED|95.0|-1.781|11.689|||ANCOVA|||Overall Study||11.689|-1.781|0.148
73983449|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|0.993|STANDARD_ERROR_OF_MEAN|3.4645||0.775|TWO_SIDED|95.0|-5.869|7.855|||ANCOVA|||Overall Study||7.855|-5.869|0.775
73983450|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|-1.799|STANDARD_ERROR_OF_MEAN|3.0432||0.556|TWO_SIDED|95.0|-7.826|4.229|||ANCOVA|||Overall Study||4.229|-7.826|0.556
73983451|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|3.566|STANDARD_ERROR_OF_MEAN|3.0079||0.238|TWO_SIDED|95.0|-2.391|9.524|||ANCOVA|||Overall Study||9.524|-2.391|0.238
73983452|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|3.811|STANDARD_ERROR_OF_MEAN|5.4552||0.488|TWO_SIDED|95.0|-7.152|14.774|||ANCOVA|||Dysglycemic||14.774|-7.152|0.488
73983453|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|4.659|STANDARD_ERROR_OF_MEAN|5.4845||0.4|TWO_SIDED|95.0|-6.363|15.68|||ANCOVA|||Dysglycemic||15.680|-6.363|0.400
73983454|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|4.7651||0.826|TWO_SIDED|95.0|-8.525|10.626|||ANCOVA|||Dysglycemic||10.626|-8.525|0.826
73983455|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|4.182|STANDARD_ERROR_OF_MEAN|4.7627||0.384|TWO_SIDED|95.0|-5.389|13.753|||ANCOVA|||Dysglycemic||13.753|-5.389|0.384
73983456|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|5.563|STANDARD_ERROR_OF_MEAN|4.4636||0.217|TWO_SIDED|95.0|-3.36|14.486|||ANCOVA|||T2DM||14.486|-3.360|0.217
73983457|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|-2.019|STANDARD_ERROR_OF_MEAN|4.5491||0.659|TWO_SIDED|95.0|-11.112|7.074|||ANCOVA|||T2DM||7.074|-11.112|0.659
73983458|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|-4.316|STANDARD_ERROR_OF_MEAN|4.0556||0.291|TWO_SIDED|95.0|-12.423|3.791|||ANCOVA|||T2DM||3.791|-12.423|0.291
73983459|NCT03320941|147512236|OTHER|Dose Finding|Mean Difference (Final Values)|2.913|STANDARD_ERROR_OF_MEAN|4.0035||0.47|TWO_SIDED|95.0|-5.09|10.916|||ANCOVA|||T2DM||10.916|-5.090|0.470
73983460|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|1.308|STANDARD_ERROR_OF_MEAN|5.2049||0.802|TWO_SIDED|95.0|-9.001|11.617|||ANCOVA|||Overall Study||11.617|-9.001|0.802
73983461|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|-1.812|STANDARD_ERROR_OF_MEAN|5.4301||0.739|TWO_SIDED|95.0|-12.567|8.943|||ANCOVA|||Overall Study||8.943|-12.567|0.739
73983462|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|0.588|STANDARD_ERROR_OF_MEAN|4.7125||0.901|TWO_SIDED|95.0|-8.745|9.922|||ANCOVA|||Overall Study||9.922|-8.745|0.901
73983463|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|5.278|STANDARD_ERROR_OF_MEAN|4.6095||0.255|TWO_SIDED|95.0|-3.852|14.407|||ANCOVA|||Overall Study||14.407|-3.852|0.255
73874189|NCT03201419|147290604|SUPERIORITY||Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.14|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.14|
73983464|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|0.928|STANDARD_ERROR_OF_MEAN|8.5585||0.914|TWO_SIDED|95.0|-16.271|18.127|||ANCOVA|||Dysglycemic||18.127|-16.271|0.914
73983465|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|9.2308||0.959|TWO_SIDED|95.0|-19.03|18.07|||ANCOVA|||Dysglycemic||18.070|-19.030|0.959
73983466|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|6.572|STANDARD_ERROR_OF_MEAN|7.422||0.38|TWO_SIDED|95.0|-8.343|21.487|||ANCOVA|||Dysglycemic||21.487|-8.343|0.380
73983467|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|6.121|STANDARD_ERROR_OF_MEAN|7.5174||0.419|TWO_SIDED|95.0|-8.986|21.228|||ANCOVA|||Dysglycemic||21.228|-8.986|0.419
73983468|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|0.785|STANDARD_ERROR_OF_MEAN|6.6209||0.906|TWO_SIDED|95.0|-12.45|14.02|||ANCOVA|||T2DM||14.020|-12.450|0.906
73983469|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|-4.504|STANDARD_ERROR_OF_MEAN|6.8489||0.513|TWO_SIDED|95.0|-18.195|9.187|||ANCOVA|||T2DM||9.187|-18.195|0.513
73983470|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|-4.237|STANDARD_ERROR_OF_MEAN|6.23||0.499|TWO_SIDED|95.0|-16.691|8.216|||ANCOVA|||T2DM||8.216|-16.691|0.499
73983471|NCT03320941|147512237|OTHER|Dose Finding|Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|5.9073||0.516|TWO_SIDED|95.0|-7.948|15.669|||ANCOVA|||T2DM||15.669|-7.948|0.516
73983472|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|44.82||||0.625|TWO_SIDED|95.0|-136.644|226.284|||ANCOVA|||Overall Study||226.284|-136.644|0.625
73874190|NCT03201419|147290604|SUPERIORITY||Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.07|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.07|
73983473|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|162.273||||0.079|TWO_SIDED|95.0|-19.326|343.871|||ANCOVA|||Overall Study||343.871|-19.326|0.079
73983474|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|69.062||||0.384|TWO_SIDED|95.0|-87.493|225.617|||ANCOVA|||Overall Study||225.617|-87.493|0.384
73983475|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|37.733||||0.627|TWO_SIDED|95.0|-115.58|191.045|||ANCOVA|||Overall Study||191.045|-115.580|0.627
73983476|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|22.879||||0.797|TWO_SIDED|95.0|-155.244|201.003|||ANCOVA|||Dysglycemic||201.003|-155.244|0.797
73983477|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|12.891||||0.882|TWO_SIDED|95.0|-160.215|185.996|||ANCOVA|||Dysglycemic||185.996|-160.215|0.882
73983478|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|-30.447||||0.675|TWO_SIDED|95.0|-175.796|114.902|||ANCOVA|||Dysglycemic||114.902|-175.796|0.675
73983479|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|-37.264||||0.607|TWO_SIDED|95.0|-182.099|107.571|||ANCOVA|||Dysglycemic||107.571|-182.099|0.607
73983480|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|84.822||||0.591|TWO_SIDED|95.0|-229.131|398.775|||ANCOVA|||T2DM||398.775|-229.131|0.591
73983481|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|287.328||||0.066|TWO_SIDED|95.0|-19.533|594.19|||ANCOVA|||T2DM||594.190|-19.533|0.066
73983482|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|156.017||||0.252|TWO_SIDED|95.0|-113.963|425.997|||ANCOVA|||T2DM||425.997|-113.963|0.252
73983483|NCT03320941|147512238|OTHER|Dose Finding|Mean Difference (Final Values)|103.135||||0.431|TWO_SIDED|95.0|-157.287|363.556|||ANCOVA|||T2DM||363.556|-157.287|0.431
73983484|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-65.1|STANDARD_ERROR_OF_MEAN|13.03|<|0.001|TWO_SIDED|95.0|-90.864|-39.251|||ANCOVA|||Overall Study||-39.251|-90.864|<0.001
73983485|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-67.7|STANDARD_ERROR_OF_MEAN|13.21|<|0.001|TWO_SIDED|95.0|-93.848|-41.542|||ANCOVA|||Overall Study||-41.542|-93.848|<0.001
73874191|NCT03201419|147290605|SUPERIORITY||Mean Difference|-0.139||||0.4214|TWO_SIDED|95.0|-0.48|0.201||Threshold for significance at 0.05 level.|MMRM|||||0.201|-0.480|0.4214
73874192|NCT03201419|147290605|SUPERIORITY||Mean Difference|-0.587||||0.0101|TWO_SIDED|95.0|-1.034|-0.141||Threshold for significance at 0.05 level.|MMRM|||||-0.141|-1.034|0.0101
73874193|NCT03201419|147290605|SUPERIORITY||Mean Difference|-0.148||||0.5203|TWO_SIDED|95.0|-0.599|0.304||Threshold for significance at 0.05 level.|MMRM|||||0.304|-0.599|0.5203
73983486|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-70.8|STANDARD_ERROR_OF_MEAN|11.67|<|0.001|TWO_SIDED|95.0|-93.942|-47.735|||ANCOVA|||Overall Study||-47.735|-93.942|<0.001
73983487|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-74.4|STANDARD_ERROR_OF_MEAN|11.47|<|0.001|TWO_SIDED|95.0|-97.117|-51.704|||ANCOVA|||Overall Study||-51.704|-97.117|<0.001
73983488|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-86.9|STANDARD_ERROR_OF_MEAN|24.35|<|0.001|TWO_SIDED|95.0|-135.78|-38.013|||ANCOVA|||Dysglycemic||-38.013|-135.780|<0.001
73983489|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-86.1|STANDARD_ERROR_OF_MEAN|24.01|<|0.001|TWO_SIDED|95.0|-134.266|-37.874|||ANCOVA|||Dysglycemic||-37.874|-134.266|<0.001
73983490|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-81.1|STANDARD_ERROR_OF_MEAN|21.04|<|0.001|TWO_SIDED|95.0|-123.369|-38.883|||ANCOVA|||Dysglycemic||-38.883|-123.369|<0.001
73983491|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-84.9|STANDARD_ERROR_OF_MEAN|21.03|<|0.001|TWO_SIDED|95.0|-127.104|-42.669|||ANCOVA|||Dysglycemic||-42.669|-127.104|<0.001
73983492|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-47.5|STANDARD_ERROR_OF_MEAN|13.52|<|0.001|TWO_SIDED|95.0|-74.493|-20.461|||ANCOVA|||T2DM||-20.461|-74.493|<0.001
73983493|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-53.1|STANDARD_ERROR_OF_MEAN|13.93|<|0.001|TWO_SIDED|95.0|-80.914|-25.251|||ANCOVA|||T2DM||-25.251|-80.914|<0.001
73874194|NCT03201419|147290605|SUPERIORITY||Mean Difference|0.055||||0.8483|TWO_SIDED|95.0|-0.508|0.617||Threshold for significance at 0.05 level.|MMRM|||||0.617|-0.508|0.8483
73874195|NCT03201419|147290605|SUPERIORITY||Mean Difference|-0.147||||0.6357|TWO_SIDED|95.0|-0.759|0.464||Threshold for significance at 0.05 level.|MMRM|||||0.464|-0.759|0.6357
73983494|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-61.8|STANDARD_ERROR_OF_MEAN|12.43|<|0.001|TWO_SIDED|95.0|-86.627|-36.937|||ANCOVA|||T2DM||-36.937|-86.627|<0.001
73983495|NCT03320941|147512239|OTHER|Dose Finding|Mean Difference (Final Values)|-65.0|STANDARD_ERROR_OF_MEAN|12.15|<|0.001|TWO_SIDED|95.0|-89.291|-40.713|||ANCOVA|||T2DM||-40.713|-89.291|<0.001
73983496|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|-0.556|STANDARD_ERROR_OF_MEAN|1.845||0.764|TWO_SIDED|95.0|-4.21|3.098|||ANCOVA|||Overall Study||3.098|-4.210|0.764
73983497|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|1.289|STANDARD_ERROR_OF_MEAN|1.8741||0.493|TWO_SIDED|95.0|-2.423|5.001|||ANCOVA|||Overall Study||5.001|-2.423|0.493
73983498|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|-2.621|STANDARD_ERROR_OF_MEAN|1.6596||0.117|TWO_SIDED|95.0|-5.908|0.666|||ANCOVA|||Overall Study||0.666|-5.908|0.117
73874196|NCT03201419|147290605|SUPERIORITY||Mean Difference|0.25||||0.2222|TWO_SIDED|95.0|-0.152|0.652||Threshold for significance at 0.05 level.|MMRM|||||0.652|-0.152|0.2222
73874197|NCT03201419|147290606|SUPERIORITY||Mean Difference|-0.166||||0.2909|TWO_SIDED|95.0|-0.474|0.143||Threshold for significance at 0.05 level.|MMRM|||||0.143|-0.474|0.2909
73983499|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|-1.818|STANDARD_ERROR_OF_MEAN|1.6349||0.269|TWO_SIDED|95.0|-5.056|1.421|||ANCOVA|||Overall Study||1.421|-5.056|0.269
73983500|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|1.671|STANDARD_ERROR_OF_MEAN|1.1677||0.159|TWO_SIDED|95.0|-0.676|4.017|||ANCOVA|||Dysglycemic||4.017|-0.676|0.159
73983501|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|5.641|STANDARD_ERROR_OF_MEAN|1.1678|<|0.001|TWO_SIDED|95.0|3.294|7.988|||ANCOVA|||Dysglycemic||7.988|3.294|<0.001
73983502|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|1.155|STANDARD_ERROR_OF_MEAN|1.0371||0.271|TWO_SIDED|95.0|-0.929|3.239|||ANCOVA|||Dysglycemic||3.239|-0.929|0.271
73983503|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|1.019||0.841|TWO_SIDED|95.0|-1.842|2.253|||ANCOVA|||Dysglycemic||2.253|-1.842|0.841
73983504|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|-3.725|STANDARD_ERROR_OF_MEAN|2.518||0.144|TWO_SIDED|95.0|-8.758|1.309|||ANCOVA|||T2DM||1.309|-8.758|0.144
73983505|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|-0.877|STANDARD_ERROR_OF_MEAN|2.5906||0.736|TWO_SIDED|95.0|-6.055|4.302|||ANCOVA|||T2DM||4.302|-6.055|0.736
73983506|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|-3.431|STANDARD_ERROR_OF_MEAN|2.3113||0.143|TWO_SIDED|95.0|-8.051|1.19|||ANCOVA|||T2DM||1.190|-8.051|0.143
73874198|NCT03201419|147290606|SUPERIORITY||Mean Difference|-0.418||||0.044|TWO_SIDED|95.0|-0.824|-0.011||Threshold for significance at 0.05 level.|MMRM|||||-0.011|-0.824|0.0440
73983507|NCT03320941|147512240|OTHER|Dose Finding|Mean Difference (Final Values)|-1.991|STANDARD_ERROR_OF_MEAN|2.2659||0.383|TWO_SIDED|95.0|-6.521|2.538|||ANCOVA|||T2DM||2.538|-6.521|0.383
73983508|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|0.654|STANDARD_ERROR_OF_MEAN|1.1543||0.572|TWO_SIDED|95.0|-1.632|2.941|||ANCOVA|||Overall Study||2.941|-1.632|0.572
73983509|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|0.655|STANDARD_ERROR_OF_MEAN|1.1738||0.578|TWO_SIDED|95.0|-1.67|2.98|||ANCOVA|||Overall Study||2.980|-1.670|0.578
73983510|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|-1.048|STANDARD_ERROR_OF_MEAN|1.0479||0.319|TWO_SIDED|95.0|-3.124|1.028|||ANCOVA|||Overall Study||1.028|-3.124|0.319
73983511|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|-0.374|STANDARD_ERROR_OF_MEAN|1.0303||0.717|TWO_SIDED|95.0|-2.416|1.667|||ANCOVA|||Overall Study||1.667|-2.416|0.717
73983512|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.563||0.317|TWO_SIDED|95.0|-0.562|1.701|||ANCOVA|||Dysglycemic||1.701|-0.562|0.317
73983513|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|1.609|STANDARD_ERROR_OF_MEAN|0.5716||0.007|TWO_SIDED|95.0|0.46|2.758|||ANCOVA|||Dysglycemic||2.758|0.460|0.007
73983514|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|0.352|STANDARD_ERROR_OF_MEAN|0.5029||0.487|TWO_SIDED|95.0|-0.659|1.362|||ANCOVA|||Dysglycemic||1.362|-0.659|0.487
73983515|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.4917||0.833|TWO_SIDED|95.0|-0.884|1.092|||ANCOVA|||Dysglycemic||1.092|-0.884|0.833
73983516|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|0.605|STANDARD_ERROR_OF_MEAN|2.073||0.771|TWO_SIDED|95.0|-3.541|4.752|||ANCOVA|||T2DM||4.752|-3.541|0.771
73874199|NCT03201419|147290606|SUPERIORITY||Mean Difference|0.128||||0.5438|TWO_SIDED|95.0|-0.288|0.545||Threshold for significance at 0.05 level.|MMRM|||||0.545|-0.288|0.5438
73874200|NCT03201419|147290606|SUPERIORITY||Mean Difference|0.441||||0.096|TWO_SIDED|95.0|-0.079|0.962||Threshold for significance at 0.05 level.|MMRM|||||0.962|-0.079|0.0960
73874201|NCT03201419|147290606|SUPERIORITY||Mean Difference|-0.04||||0.8826|TWO_SIDED|95.0|-0.568|0.488||Threshold for significance at 0.05 level.|MMRM|||||0.488|-0.568|0.8826
73874202|NCT03201419|147290606|SUPERIORITY||Mean Difference|0.394||||0.0344|TWO_SIDED|95.0|0.029|0.759||Threshold for significance at 0.05 level.|MMRM|||||0.759|0.029|0.0344
73874203|NCT03201419|147290607|SUPERIORITY||Mean Difference|-0.132||||0.4732|TWO_SIDED|95.0|-0.496|0.231||Threshold for significance at 0.05 level.|MMRM|||||0.231|-0.496|0.4732
73983517|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|2.1453||0.991|TWO_SIDED|95.0|-4.315|4.267|||ANCOVA|||T2DM||4.267|-4.315|0.991
73983518|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|-2.166|STANDARD_ERROR_OF_MEAN|1.9486||0.271|TWO_SIDED|95.0|-6.064|1.732|||ANCOVA|||T2DM||1.732|-6.064|0.271
73983519|NCT03320941|147512241|OTHER|Dose Finding|Mean Difference (Final Values)|-0.792|STANDARD_ERROR_OF_MEAN|1.8889||0.676|TWO_SIDED|95.0|-4.57|2.986|||ANCOVA|||T2DM||2.986|-4.570|0.676
73983520|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|4.7535||0.968|TWO_SIDED|95.0|-9.603|9.222|||ANCOVA|||Overall Study||9.222|-9.603|0.968
73983521|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|-1.883|STANDARD_ERROR_OF_MEAN|4.7545||0.693|TWO_SIDED|95.0|-11.297|7.531|||ANCOVA|||Overall Study||7.531|-11.297|0.693
73983522|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|-5.236|STANDARD_ERROR_OF_MEAN|4.2623||0.222|TWO_SIDED|95.0|-13.676|3.203|||ANCOVA|||Overall Study||3.203|-13.676|0.222
73983523|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|-7.403|STANDARD_ERROR_OF_MEAN|4.1637||0.078|TWO_SIDED|95.0|-15.648|0.841|||ANCOVA|||Overall Study||0.841|-15.648|0.078
73983524|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|-1.142|STANDARD_ERROR_OF_MEAN|6.0033||0.85|TWO_SIDED|95.0|-13.194|10.91|||ANCOVA|||Dysglycemic||10.910|-13.194|0.850
73983525|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|-6.048|STANDARD_ERROR_OF_MEAN|5.7919||0.301|TWO_SIDED|95.0|-17.676|5.58|||ANCOVA|||Dysglycemic||5.580|-17.676|0.301
73983526|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|-5.587|STANDARD_ERROR_OF_MEAN|5.2598||0.293|TWO_SIDED|95.0|-16.147|4.972|||ANCOVA|||Dysglycemic||4.972|-16.147|0.293
73983527|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|-6.943|STANDARD_ERROR_OF_MEAN|5.2191||0.189|TWO_SIDED|95.0|-17.421|3.535|||ANCOVA|||Dysglycemic||3.535|-17.421|0.189
73983528|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|0.676|STANDARD_ERROR_OF_MEAN|7.2441||0.926|TWO_SIDED|95.0|-13.8|15.152|||ANCOVA|||T2DM||15.152|-13.800|0.926
73983529|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|1.202|STANDARD_ERROR_OF_MEAN|7.5086||0.873|TWO_SIDED|95.0|-13.802|16.207|||ANCOVA|||T2DM||16.207|-13.802|0.873
73983530|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|-5.779|STANDARD_ERROR_OF_MEAN|6.6977||0.391|TWO_SIDED|95.0|-19.164|7.605|||ANCOVA|||T2DM||7.605|-19.164|0.391
73983531|NCT03320941|147512242|OTHER|Dose Finding|Mean Difference (Final Values)|-7.591|STANDARD_ERROR_OF_MEAN|6.3822||0.239|TWO_SIDED|95.0|-20.345|5.163|||ANCOVA|||T2DM||5.163|-20.345|0.239
73983532|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|-3.086|STANDARD_ERROR_OF_MEAN|2.8326||0.278|TWO_SIDED|95.0|-8.696|2.525|||ANCOVA|||Overall Study||2.525|-8.696|0.278
73983533|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|-0.977|STANDARD_ERROR_OF_MEAN|2.859||0.733|TWO_SIDED|95.0|-6.639|4.686|||ANCOVA|||Overall Study||4.686|-6.639|0.733
73983534|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|-4.507|STANDARD_ERROR_OF_MEAN|2.5118||0.075|TWO_SIDED|95.0|-9.482|0.468|||ANCOVA|||Overall Study||0.468|-9.482|0.075
73983535|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|-2.268|STANDARD_ERROR_OF_MEAN|2.4659||0.36|TWO_SIDED|95.0|-7.152|2.616|||ANCOVA|||Overall Study||2.616|-7.152|0.360
73983536|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|-3.147|STANDARD_ERROR_OF_MEAN|4.1699||0.416|TWO_SIDED|95.0|-11.792|4.959|||ANCOVA|||Dysglycemic||4.959|-11.792|0.416
73983537|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|-1.634|STANDARD_ERROR_OF_MEAN|4.1121||0.693|TWO_SIDED|95.0|-9.893|6.625|||ANCOVA|||Dysglycemic||6.625|-9.893|0.693
73874204|NCT03201419|147290607|SUPERIORITY||Mean Difference|-0.224||||0.3394|TWO_SIDED|95.0|-0.685|0.237||Threshold for significance at 0.05 level.|MMRM|||||0.237|-0.685|0.3394
73983538|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|-2.906|STANDARD_ERROR_OF_MEAN|3.6351||0.428|TWO_SIDED|95.0|-10.207|4.396|||ANCOVA|||Dysglycemic||4.396|-10.207|0.428
73983539|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|2.201|STANDARD_ERROR_OF_MEAN|3.6414||0.548|TWO_SIDED|95.0|-5.113|9.515|||ANCOVA|||Dysglycemic||9.515|-5.113|0.548
73983540|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|-2.636|STANDARD_ERROR_OF_MEAN|3.8828||0.5|TWO_SIDED|95.0|-10.4|5.128|||ANCOVA|||T2DM||5.128|-10.400|0.500
73983541|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|3.9906||0.837|TWO_SIDED|95.0|-8.805|7.154|||ANCOVA|||T2DM||7.154|-8.805|0.837
73983542|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|-5.594|STANDARD_ERROR_OF_MEAN|3.4818||0.113|TWO_SIDED|95.0|-12.556|1.368|||ANCOVA|||T2DM||1.368|-12.556|0.113
73983543|NCT03320941|147512243|OTHER|Dose Finding|Mean Difference (Final Values)|-5.66|STANDARD_ERROR_OF_MEAN|3.3512||0.096|TWO_SIDED|95.0|-12.361|1.041|||ANCOVA|||T2DM||1.041|-12.361|0.096
73983544|NCT01838499|147512245|SUPERIORITY_OR_OTHER||Difference in proportions|0.051|||>|0.05|TWO_SIDED|80.0|-0.067|0.169|||Mixed Models Analysis||MEDI8968 - placebo|Analysis of proportion of Responders for Physician's Global Assessment (PGA score 0, 1 or 2) at Week 12 - LOCF. Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.||0.169|-0.067|>0.05
73983545|NCT01838499|147512246|SUPERIORITY_OR_OTHER||Difference in proportions|-0.065|||>|0.05|TWO_SIDED|80.0|-0.205|0.076|||Mixed Models Analysis|||Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.||0.076|-0.205|>0.05
73983546|NCT01838499|147512247|SUPERIORITY_OR_OTHER||Change from baseline (at week 12)|-0.03||||0.945|TWO_SIDED|80.0|-0.63|0.57|||ANCOVA||MEDI8968 - Placebo|Analysis of change from baseline (Week 12) estimated from ANCOVA model with tmt group and PGA stratum at randomisation included in the model and average daily pain at baseline as a covariate||0.57|-0.63|0.945
74033915|NCT01728584|147620711|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.7|||||TWO_SIDED|95.0|-3.01|-0.38|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||-0.38|-3.01|
74033916|NCT01728584|147620711|SUPERIORITY_OR_OTHER||Difference in LS Means|2.41|||||TWO_SIDED|95.0|1.08|3.74|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||3.74|1.08|
73983547|NCT03614923|147512248|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints would be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|Least Squares (LS) Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.319||0.2364|TWO_SIDED|95.0|-1.01|0.25||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in NPS as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline NPS as covariate; and subject as random effect.||0.25|-1.01|0.2364
73983548|NCT03614923|147512248|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.316||0.2024|TWO_SIDED|95.0|-1.03|0.22||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in NPS as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline NPS as covariate; and subject as random effect.||0.22|-1.03|0.2024
73983549|NCT03614923|147512249|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-6.64|STANDARD_ERROR_OF_MEAN|4.383||0.133|TWO_SIDED|95.0|-15.34|2.06||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in SNOT-22 as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline SNOT-22 as covariate; and subject as random effect.||2.06|-15.34|0.1330
73983550|NCT03614923|147512249|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|4.375||0.6464|TWO_SIDED|95.0|-10.7|6.67||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in SNOT-22 as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline SNOT-22 as covariate; and subject as random effect.||6.67|-10.70|0.6464
74033917|NCT01728584|147620712|SUPERIORITY_OR_OTHER||Difference in LS Means|0.35||||0.148|TWO_SIDED|95.0|-0.13|0.84|||ANOVA|Analysis of variance (ANOVA) model included factors depth of NMB, level of pressure, gender and surgeon|Difference is deep versus standard NMB|||0.84|-0.13|0.148
74033918|NCT01728584|147620712|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.17||||0.494|TWO_SIDED|95.0|-0.67|0.33||To control for multiple testing, this difference was formally tested only if comparison of surgeon's overall satisfaction with surgical conditions for deep versus standard NMB was significant at the 5% level, with greater satisfaction for deep NMB.|ANOVA|ANOVA model included factors depth of NMB, level of pressure, gender and surgeon|Difference is low versus standard pressure|Key secondary hypothesis - low insufflation pressure improves overall average pain score in first 24 hours compared to standard insufflation pressure||0.33|-0.67|0.494
74033919|NCT01728584|147620713|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2|||||TWO_SIDED|95.0|-0.92|0.52|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.52|-0.92|
74033920|NCT01728584|147620713|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.65|||||TWO_SIDED|95.0|-1.27|-0.02|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon||-0.02|-1.27|
74033921|NCT01728584|147620713|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.15|||||TWO_SIDED|95.0|-0.84|0.53|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.53|-0.84|
73874205|NCT03201419|147290607|SUPERIORITY||Mean Difference|-0.012||||0.96|TWO_SIDED|95.0|-0.488|0.463||Threshold for significance at 0.05 level.|MMRM|||||0.463|-0.488|0.9600
74033922|NCT01728584|147620713|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.45|||||TWO_SIDED|95.0|-1.15|0.26|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon||0.26|-1.15|
74033923|NCT01728584|147620713|SUPERIORITY_OR_OTHER||Difference in LS Means|0.05|||||TWO_SIDED|95.0|-0.69|0.78|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.78|-0.69|
74033924|NCT01728584|147620713|SUPERIORITY_OR_OTHER||Difference in LS Means|0.49|||||TWO_SIDED|95.0|-0.17|1.16|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||1.16|-0.17|
74033925|NCT01728584|147620714|SUPERIORITY_OR_OTHER||Difference in LS Means|0.91||||0.063|TWO_SIDED|95.0|-0.05|1.87||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.87|-0.05|0.063
74033926|NCT01728584|147620715|SUPERIORITY_OR_OTHER||Difference in LS Means|0.82||||0.004|TWO_SIDED|95.0|0.27|1.37||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.37|0.27|0.004
74033927|NCT01728584|147620716|SUPERIORITY_OR_OTHER||Difference in LS Means|1.12||||0.006|TWO_SIDED|95.0|0.32|1.92||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.92|0.32|0.006
73874206|NCT03201419|147290607|SUPERIORITY||Mean Difference|0.463||||0.1131|TWO_SIDED|95.0|-0.111|1.037||Threshold for significance at 0.05 level.|MMRM|||||1.037|-0.111|0.1131
73874207|NCT03201419|147290607|SUPERIORITY||Mean Difference|-0.124||||0.6853|TWO_SIDED|95.0|-0.729|0.48||Threshold for significance at 0.05 level.|MMRM|||||0.480|-0.729|0.6853
73983551|NCT01882088|147512272|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-06|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||0.000002
74033928|NCT01728584|147620717|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.61||||0.073|TWO_SIDED|95.0|-1.27|0.06||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||0.06|-1.27|0.073
73956048|NCT00991276|147447814|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.45|STANDARD_ERROR_OF_MEAN|1.3||0.0617|TWO_SIDED|95.0|-5.02|0.12||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.12|-5.02|0.0617
73956049|NCT00991276|147447814|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.35|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|-8.91|-3.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.80|-8.91|<0.0001
73956050|NCT00991276|147447814|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.28||0.0028|TWO_SIDED|95.0|1.37|6.44||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||6.44|1.37|0.0028
74033929|NCT01728584|147620718|SUPERIORITY_OR_OTHER||Difference in LS Means|0.74||||0.009|TWO_SIDED|95.0|0.19|1.28||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.28|0.19|0.009
74033930|NCT05906732|147620730|SUPERIORITY||LS Mean|-9.6||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0030
74033931|NCT05906732|147620731|SUPERIORITY||LS Mean|-6.5||||0.0266|TWO_SIDED||||||Mixed Models Analysis|||||||0.0266
74033932|NCT05906732|147620732|SUPERIORITY||LS Mean|-7.8||||0.0067|TWO_SIDED||||||Mixed Models Analysis|||||||0.0067
73874208|NCT03201419|147290607|SUPERIORITY||Mean Difference|0.166||||0.4364|TWO_SIDED|95.0|-0.254|0.587||Threshold for significance at 0.05 level.|MMRM|||||0.587|-0.254|0.4364
73874209|NCT03201419|147290608|SUPERIORITY||Mean Difference|-0.299||||0.1106|TWO_SIDED|95.0|-0.667|0.069||Threshold for significance at 0.05 level.|MMRM|||||0.069|-0.667|0.1106
73956051|NCT00991276|147447815|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.0056|TWO_SIDED|95.0|-1.17|-0.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.21|-1.17|0.0056
74033933|NCT05906732|147620733|SUPERIORITY||LS Mean|-3.9||||0.1106|TWO_SIDED||||||Mixed Models Analysis|||||||0.1106
74033934|NCT05906732|147620734|SUPERIORITY||LS Mean|-4.2||||0.0908|TWO_SIDED||||||Mixed Models Analysis|||||||0.0908
74033935|NCT05906732|147620735|SUPERIORITY||LS Mean|-1.2||||0.4038|TWO_SIDED||||||Mixed Models Analysis|||||||0.4038
74033936|NCT05906732|147620736|SUPERIORITY||LS Mean|1.5||||0.6255|TWO_SIDED||||||Mixed Models Analysis|||||||0.6255
74033937|NCT05906732|147620737|SUPERIORITY||LS Mean|0.2||||0.514|TWO_SIDED||||||Mixed Models Analysis|||||||0.5140
74033938|NCT05906732|147620738|SUPERIORITY||LS Mean|0.8||||0.5675|TWO_SIDED||||||Mixed Models Analysis|||||||0.5675
74033939|NCT05906732|147620739|SUPERIORITY||LS Mean|3.4||||0.764|TWO_SIDED||||||Mixed Models Analysis|||||||0.7640
74033940|NCT05906732|147620740|SUPERIORITY||LS Mean|-2.8||||0.2437|TWO_SIDED||||||Mixed Models Analysis|||||||.2437
74033941|NCT05906732|147620741|SUPERIORITY||LS Mean|-0.8||||0.4229|TWO_SIDED||||||Mixed Models Analysis|||||||0.4229
74033942|NCT05906732|147620742|SUPERIORITY||LS Mean|-0.1||||0.4887|TWO_SIDED||||||Mixed Models Analysis|||||||0.4887
74033943|NCT05906732|147620743|SUPERIORITY||LS Mean|-3.1||||0.2042|TWO_SIDED||||||Mixed Models Analysis|||||||0.2042
74033944|NCT05906732|147620744|SUPERIORITY||Mean Difference (Net)|-2.2||||0.2644|TWO_SIDED||||||Mixed Models Analysis|||||||0.2644
74033945|NCT05906732|147620762|SUPERIORITY||Mean Difference (Net)|4.28||||0.3169|TWO_SIDED||||||t-test, 2 sided|||||||0.3169
74033946|NCT05906732|147620763|SUPERIORITY||Mean Difference (Net)|6.78||||0.1066|TWO_SIDED||||||t-test, 2 sided|||||||0.1066
74033947|NCT05906732|147620764|SUPERIORITY||Mean Difference (Net)|-16.06||||0.0443|TWO_SIDED||||||t-test, 2 sided|||||||0.0443
74033948|NCT05906732|147620765|SUPERIORITY||Mean Difference (Net)|-9.06||||0.0815|TWO_SIDED||||||t-test, 2 sided|||||||0.0815
74033949|NCT05906732|147620766|SUPERIORITY||Mean Difference (Net)|-10.67||||0.0137|TWO_SIDED||||||t-test, 2 sided|||||||0.0137
74033950|NCT05906732|147620767|SUPERIORITY||Mean Difference (Net)|-4.0||||0.3539|TWO_SIDED||||||t-test, 2 sided|||||||0.3539
73874210|NCT03201419|147290608|SUPERIORITY||Mean Difference|-0.163||||0.5005|TWO_SIDED|95.0|-0.639|0.313||Threshold for significance at 0.05 level.|MMRM|||||0.313|-0.639|0.5005
73874211|NCT03201419|147290608|SUPERIORITY||Mean Difference|0.107||||0.6604|TWO_SIDED|95.0|-0.372|0.586||Threshold for significance at 0.05 level.|MMRM|||||0.586|-0.372|0.6604
73874212|NCT03201419|147290608|SUPERIORITY||Mean Difference|0.283||||0.3178|TWO_SIDED|95.0|-0.275|0.842||Threshold for significance at 0.05 level.|MMRM|||||0.842|-0.275|0.3178
73874213|NCT03201419|147290608|SUPERIORITY||Mean Difference|-0.096||||0.7561|TWO_SIDED|95.0|-0.701|0.51||Threshold for significance at 0.05 level.|MMRM|||||0.510|-0.701|0.7561
73874214|NCT03201419|147290608|SUPERIORITY||Mean Difference|0.037||||0.8614|TWO_SIDED|95.0|-0.378|0.452||Threshold for significance at 0.05 level.|MMRM|||||0.452|-0.378|0.8614
73874215|NCT03201419|147290609|SUPERIORITY||Odds Ratio (OR)|1.759||||0.117|TWO_SIDED|95.0|0.869|3.56||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.560|0.869|0.117
74033951|NCT05906732|147620768|SUPERIORITY||Mean Difference (Net)|9.78||||0.1377|TWO_SIDED||||||t-test, 2 sided|||||||0.1377
74033952|NCT05906732|147620769|SUPERIORITY||Mean Difference (Net)|-2.69||||0.6184|TWO_SIDED||||||t-test, 2 sided|||||||0.6184
73874216|NCT03201419|147290609|SUPERIORITY||Odds Ratio (OR)|2.505||||0.048|TWO_SIDED|95.0|1.01|6.214||Threshold for significance at 0.05 level.|Regression, Logistic|||||6.214|1.010|0.048
73874217|NCT03201419|147290609|SUPERIORITY||Odds Ratio (OR)|1.42||||0.46|TWO_SIDED|95.0|0.56|3.602||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.602|0.560|0.460
73874218|NCT03201419|147290609|SUPERIORITY||Odds Ratio (OR)|1.704||||0.367|TWO_SIDED|95.0|0.535|5.427||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.427|0.535|0.367
73874219|NCT03201419|147290609|SUPERIORITY||Odds Ratio (OR)|1.689||||0.407|TWO_SIDED|95.0|0.489|5.825||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.825|0.489|0.407
73874220|NCT03201419|147290609|SUPERIORITY||Odds Ratio (OR)|1.069||||0.876|TWO_SIDED|95.0|0.462|2.473||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.473|0.462|0.876
73874221|NCT03201419|147290610|SUPERIORITY||Odds Ratio (OR)|0.971||||0.937|TWO_SIDED|95.0|0.47|2.005||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.005|0.470|0.937
73874222|NCT03201419|147290610|SUPERIORITY||Odds Ratio (OR)|4.738||||0.028|TWO_SIDED|95.0|1.183|18.968||Threshold for significance at 0.05 level.|Regression, Logistic|||||18.968|1.183|0.028
73874223|NCT03201419|147290610|SUPERIORITY||Odds Ratio (OR)|0.513||||0.166|TWO_SIDED|95.0|0.2|1.318||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.318|0.200|0.166
73874224|NCT03201419|147290610|SUPERIORITY||Odds Ratio (OR)|0.433||||0.174|TWO_SIDED|95.0|0.129|1.447||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.447|0.129|0.174
73874225|NCT03201419|147290610|SUPERIORITY||Odds Ratio (OR)|1.425||||0.608|TWO_SIDED|95.0|0.369|5.512||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.512|0.369|0.608
73874226|NCT03201419|147290610|SUPERIORITY||Odds Ratio (OR)|0.553||||0.171|TWO_SIDED|95.0|0.237|1.292||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.292|0.237|0.171
73874227|NCT03201419|147290611|SUPERIORITY||Odds Ratio (OR)|0.928||||0.85|TWO_SIDED|95.0|0.43|2.003||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.003|0.430|0.850
73874228|NCT03201419|147290611|SUPERIORITY||Odds Ratio (OR)|2.261||||0.15|TWO_SIDED|95.0|0.745|6.862||Threshold for significance at 0.05 level.|Regression, Logistic|||||6.862|0.745|0.150
73874229|NCT03201419|147290611|SUPERIORITY||Odds Ratio (OR)|1.283||||0.632|TWO_SIDED|95.0|0.462|3.566||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.566|0.462|0.632
73874230|NCT03201419|147290611|SUPERIORITY||Odds Ratio (OR)|0.583||||0.363|TWO_SIDED|95.0|0.183|1.863||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.863|0.183|0.363
73874231|NCT03201419|147290611|SUPERIORITY||Odds Ratio (OR)|0.691||||0.555|TWO_SIDED|95.0|0.203|2.359||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.359|0.203|0.555
73874232|NCT03201419|147290611|SUPERIORITY||Odds Ratio (OR)|0.991||||0.984|TWO_SIDED|95.0|0.408|2.405||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.405|0.408|0.984
73874233|NCT03201419|147290612|SUPERIORITY||Odds Ratio (OR)|2.462||||0.046|TWO_SIDED|95.0|1.017|5.961||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.961|1.017|0.046
73874234|NCT03201419|147290612|SUPERIORITY||Odds Ratio (OR)|1.19||||0.745|TWO_SIDED|95.0|0.418|3.386||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.386|0.418|0.745
73874235|NCT03201419|147290612|SUPERIORITY||Odds Ratio (OR)|1.147||||0.79|TWO_SIDED|95.0|0.417|3.155||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.155|0.417|0.790
73874236|NCT03201419|147290612|SUPERIORITY||Odds Ratio (OR)|0.537||||0.293|TWO_SIDED|95.0|0.169|1.71||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.710|0.169|0.293
73874237|NCT03201419|147290612|SUPERIORITY||Odds Ratio (OR)|0.881||||0.843|TWO_SIDED|95.0|0.252|3.076||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.076|0.252|0.843
73874238|NCT03201419|147290612|SUPERIORITY||Odds Ratio (OR)|0.877||||0.763|TWO_SIDED|95.0|0.375|2.053||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.053|0.375|0.763
73874239|NCT03201419|147290613|SUPERIORITY||Odds Ratio (OR)|1.422|||||TWO_SIDED|95.0|0.868|2.597||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.597|0.868|
73874240|NCT03201419|147290613|SUPERIORITY||Odds Ratio (OR)|1.373|||||TWO_SIDED|95.0|0.905|2.45||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.450|0.905|
74033953|NCT05906732|147620770|SUPERIORITY||Mean Difference (Net)|3.17||||0.6627|TWO_SIDED||||||t-test, 2 sided|||||||0.6627
74033954|NCT05906732|147620771|SUPERIORITY||Mean Difference (Net)|5.78||||0.5276|TWO_SIDED||||||t-test, 2 sided|||||||0.5276
74033955|NCT05906732|147620772|SUPERIORITY||Mean Difference (Net)|15.17||||0.0399|TWO_SIDED||||||t-test, 2 sided|||||||0.0399
74033956|NCT05906732|147620773|SUPERIORITY||Mean Difference (Net)|13.56||||0.0747|TWO_SIDED||||||t-test, 2 sided|||||||0.0747
74033957|NCT05906732|147620774|SUPERIORITY|||||||0.9584|||||||t-test, 2 sided|||||||0.9584
74033958|NCT05906732|147620775|SUPERIORITY||Mean Difference (Net)|5.72||||0.6531|TWO_SIDED||||||t-test, 2 sided|||||||0.6531
74033959|NCT05906732|147620776|SUPERIORITY||Mean Difference (Net)|15.61||||0.0482|TWO_SIDED||||||t-test, 2 sided|||||||0.0482
74033960|NCT05906732|147620777|SUPERIORITY||Mean Difference (Net)|17.22||||0.0667|TWO_SIDED||||||t-test, 2 sided|||||||0.0667
74033961|NCT05906732|147620778|SUPERIORITY||Mean Difference (Net)|-37.0||||0.0131|TWO_SIDED||||||t-test, 2 sided|||||||0.0131
73983552|NCT01882088|147512273|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||0.2
73983553|NCT01882088|147512274|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.002415|||||||Wilcoxon (Mann-Whitney)|||||||0.002415
73983554|NCT01882088|147512275|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.000438|||||||Wilcoxon (Mann-Whitney)|||||||0.000438
73983555|NCT01882088|147512276|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||||||0.023
73983556|NCT01882088|147512277|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
73983557|NCT01882088|147512278|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
74033962|NCT05906732|147620779|SUPERIORITY||Mean Difference (Net)|-32.36||||0.0141|TWO_SIDED||||||t-test, 2 sided|||||||0.0141
73874241|NCT03201419|147290613|SUPERIORITY||Odds Ratio (OR)|1.284|||||TWO_SIDED|95.0|0.927|2.264||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.264|0.927|
73874242|NCT03201419|147290613|SUPERIORITY||Odds Ratio (OR)|1.145|||||TWO_SIDED|95.0|0.957|1.896||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.896|0.957|
73874243|NCT03201419|147290613|SUPERIORITY||Odds Ratio (OR)|1.079|||||TWO_SIDED|95.0|0.972|1.638||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.638|0.972|
73983558|NCT01882088|147512279|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
73983559|NCT01882088|147512280|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
73983560|NCT01882088|147512281|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00002
73983561|NCT02720198|147512292|SUPERIORITY||Mean Difference (Final Values)|1.159|STANDARD_ERROR_OF_MEAN|1.834||0.53|TWO_SIDED|95.0|-2.518|4.836|||t-test, 2 sided|||||4.836|-2.518|0.53
73983562|NCT02720198|147512293|SUPERIORITY||Odds Ratio (OR)|0.492|STANDARD_ERROR_OF_MEAN|0.806||0.428|TWO_SIDED|95.0|0.101|2.388|||Mantel Haenszel|||||2.388|0.101|0.428
73983563|NCT02720198|147512294|SUPERIORITY||Odds Ratio (OR)|0.451|STANDARD_ERROR_OF_MEAN|0.724||0.272|TWO_SIDED|95.0|0.109|1.866|||Mantel Haenszel|||||1.866|0.109|0.272
73983564|NCT02720198|147512295|SUPERIORITY||Mean Difference (Final Values)|-0.624|STANDARD_ERROR_OF_MEAN|1.428||0.664|TWO_SIDED|95.0|-3.484|2.236|||t-test, 2 sided|||||2.236|-3.484|0.664
73983565|NCT02720198|147512296|SUPERIORITY||Mean Difference (Final Values)|2.34|STANDARD_ERROR_OF_MEAN|2.199||0.292|TWO_SIDED|95.0|-2.07|6.75|||t-test, 2 sided|||||6.750|-2.070|0.292
73874244|NCT03201419|147290613|SUPERIORITY||Odds Ratio (OR)|1.023|||||TWO_SIDED|95.0|0.991|1.313||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.313|0.991|
73983566|NCT02720198|147512297|SUPERIORITY||Odds Ratio (OR)|1.063|STANDARD_ERROR_OF_MEAN|0.525||0.884|TWO_SIDED|95.0|0.38|2.971|||Mantel Haenszel|||||2.971|0.380|0.884
73983567|NCT02720198|147512298|SUPERIORITY||Odds Ratio (OR)|0.875|STANDARD_ERROR_OF_MEAN|0.65||0.905|TWO_SIDED|95.0|0.245|3.129|||Mantel Haenszel|||||3.129|0.245|0.905
73983568|NCT02720198|147512299|SUPERIORITY||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.423||0.254|TWO_SIDED|95.0|-1.211|4.492|||t-test, 2 sided|||||4.492|-1.211|0.254
74033963|NCT05906732|147620780|SUPERIORITY||Mean Difference (Net)|-44.55||||0.0019|TWO_SIDED||||||t-test, 2 sided|||||||0.0019
74033964|NCT05906732|147620781|SUPERIORITY||Mean Difference (Net)|-31.69||||0.1108|TWO_SIDED||||||t-test, 2 sided|||||||0.1108
74033965|NCT05906732|147620782|SUPERIORITY||Mean Difference (Net)|37.81||||0.184|TWO_SIDED||||||t-test, 2 sided|||||||0.1840
73874245|NCT03201419|147290614|SUPERIORITY||Mean Difference|0.52||||0.8463|TWO_SIDED|95.0|-4.75|5.78||Threshold for significance at 0.05 level.|MMRM|||||5.78|-4.75|0.8463
73874246|NCT03201419|147290614|SUPERIORITY||Mean Difference|-13.85||||0.0001|TWO_SIDED|95.0|-20.89|-6.81||Threshold for significance at 0.05 level.|MMRM|||||-6.81|-20.89|0.0001
73874247|NCT03201419|147290614|SUPERIORITY||Mean Difference|-2.84||||0.4355|TWO_SIDED|95.0|-9.99|4.32||Threshold for significance at 0.05 level.|MMRM|||||4.32|-9.99|0.4355
73874248|NCT03201419|147290614|SUPERIORITY||Mean Difference|-0.87||||0.8483|TWO_SIDED|95.0|-9.79|8.06||Threshold for significance at 0.05 level.|MMRM|||||8.06|-9.79|0.8483
73874249|NCT03201419|147290614|SUPERIORITY||Mean Difference|-1.61||||0.7336|TWO_SIDED|95.0|-10.91|7.69||Threshold for significance at 0.05 level.|MMRM|||||7.69|-10.91|0.7336
73874250|NCT03201419|147290614|SUPERIORITY||Mean Difference|-0.69||||0.8347|TWO_SIDED|95.0|-7.15|5.78||Threshold for significance at 0.05 level.|MMRM|||||5.78|-7.15|0.8347
73874251|NCT03201419|147290615|SUPERIORITY||Mean Difference|1.59||||0.5695|TWO_SIDED|95.0|-3.9|7.07||Threshold for significance at 0.05 level.|MMRM|||||7.07|-3.90|0.5695
73983569|NCT02720198|147512300|SUPERIORITY||Mean Difference (Final Values)|-3.693|STANDARD_ERROR_OF_MEAN|1.91||0.058|TWO_SIDED|95.0|-7.52|0.134|||t-test, 2 sided|||||0.134|-7.520|0.058
73983570|NCT02720198|147512301|SUPERIORITY||Mean Difference (Final Values)|-0.236|STANDARD_ERROR_OF_MEAN|2.158||0.913|TWO_SIDED|95.0|-4.559|4.088|||t-test, 2 sided|||||4.088|-4.559|0.913
73983571|NCT02720198|147512302|SUPERIORITY||Mean Difference (Final Values)|-0.459|STANDARD_ERROR_OF_MEAN|1.035||0.66|TWO_SIDED|95.0|-2.54|1.623|||t-test, 2 sided|||||1.623|-2.540|0.660
73983572|NCT03897075|147512303|SUPERIORITY|||||||0.00311|||||||Cochran-Mantel-Haenszel|||||||0.00311
73983573|NCT03897075|147512304|SUPERIORITY|||||||0.00079|||||||Cochran-Mantel-Haenszel|||||||0.00079
73983574|NCT03897075|147512305|SUPERIORITY|||||||0.09892|||||||Cochran-Mantel-Haenszel|||||||0.09892
73983575|NCT02342275|147512335|NON_INFERIORITY|Assuming that the atenolol on the propranolol response rate does not fall by greater than 15%, the noninferiority margin was selected to be -15%.|Odds Ratio (OR)|0.15|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||Treatment Difference=Propranolol vs Atenolol|The sample size required to compare propranolol and atenolol at month 6 was calculated before enrollment. Assuming the ulceration rate in both groups to be 10%, a sample size of180 patients was required for each group to show the noninferiority ofatenolol treatment with a 2-sidedα level of .05 and approximately 90% power||||<0.05
73983576|NCT04799587|147512391|SUPERIORITY|Sample size for the study was determined by assuming a baseline rate of 33% of IONV and that there will be a relative decrease of 50% in the group that receives P6 acupressure during CD. A two-sided Fisher's Exact Test, with a significance level of 0.05, group sizes of 98 are needed to achieve 80% power to detect a difference between the group proportions of 0.18. Group sizes were rounded up to 100. Statistical analyses were two-sided, and a P\<0.05 was required to reject the null hypothesis.||||||0.94|||||||Chi-squared|||The incidence of nausea and vomiting and the number of episodes between the P6 acupressure and sham acupressure groups were compared using a chi-square statistic (nominal data) or the Wilcoxon test (continuous data).||||.94
73874252|NCT03201419|147290615|SUPERIORITY||Mean Difference|-3.23||||0.3784|TWO_SIDED|95.0|-10.46|3.99||Threshold for significance at 0.05 level.|MMRM|||||3.99|-10.46|0.3784
73983577|NCT04799587|147512392|SUPERIORITY|||||||0.95|||||||Chi-squared|||The sample size for the study was determined by assuming a baseline rate of 33% of intraoperative nausea and vomiting and that there will be a relative decrease of 50% in the group that receives P6 acupressure during CD.20 Using a two-sided Fisher's Exact Test, with a significance level of 0.05, group sizes of 98 are needed to achieve 80% power to detect a difference between the group proportions of 0.18. Group sizes were rounded up to 100||||.95
73983578|NCT00515281|147512414|SUPERIORITY|||||||0.017|||||||Chi-squared|||||||0.017
73983579|NCT00515281|147512415|SUPERIORITY|||||||0.288|||||||Chi-squared|||||||0.288
73983580|NCT00515281|147512416|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
73983581|NCT00515281|147512417|SUPERIORITY|||||||0.97|||||||Chi-squared|||||||0.97
73983582|NCT00515281|147512418|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
73874253|NCT03201419|147290615|SUPERIORITY||Mean Difference|-0.17||||0.9653|TWO_SIDED|95.0|-7.67|7.34||Threshold for significance at 0.05 level.|MMRM|||||7.34|-7.67|0.9653
73874254|NCT03201419|147290615|SUPERIORITY||Mean Difference|2.97||||0.5304|TWO_SIDED|95.0|-6.35|12.29||Threshold for significance at 0.05 level.|MMRM|||||12.29|-6.35|0.5304
73874255|NCT03201419|147290615|SUPERIORITY||Mean Difference|-8.02||||0.0968|TWO_SIDED|95.0|-17.51|1.46||Threshold for significance at 0.05 level.|MMRM|||||1.46|-17.51|0.0968
73874256|NCT03201419|147290615|SUPERIORITY||Mean Difference|0.91||||0.7885|TWO_SIDED|95.0|-5.79|7.62||Threshold for significance at 0.05 level.|MMRM|||||7.62|-5.79|0.7885
73874257|NCT03201419|147290616|SUPERIORITY||Mean Difference|-1.2||||0.6792|TWO_SIDED|95.0|-6.89|4.5||Threshold for significance at 0.05 level.|MMRM|||||4.50|-6.89|0.6792
73874258|NCT03201419|147290616|SUPERIORITY||Mean Difference|-8.39||||0.0276|TWO_SIDED|95.0|-15.84|-0.93||Threshold for significance at 0.05 level.|MMRM|||||-0.93|-15.84|0.0276
73874259|NCT03201419|147290616|SUPERIORITY||Mean Difference|-0.27||||0.9445|TWO_SIDED|95.0|-7.97|7.42||Threshold for significance at 0.05 level.|MMRM|||||7.42|-7.97|0.9445
73874260|NCT03201419|147290616|SUPERIORITY||Mean Difference|2.79||||0.5637|TWO_SIDED|95.0|-6.71|12.28||Threshold for significance at 0.05 level.|MMRM|||||12.28|-6.71|0.5637
73874261|NCT03201419|147290616|SUPERIORITY||Mean Difference|-4.4||||0.387|TWO_SIDED|95.0|-14.39|5.6||Threshold for significance at 0.05 level.|MMRM|||||5.60|-14.39|0.3870
73983583|NCT00515281|147512419|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73983584|NCT00515281|147512420|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
73983585|NCT01292005|147512451|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.62
73983586|NCT01292005|147512451|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||1.0
73983587|NCT01292005|147512452|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.72
73983588|NCT01292005|147512452|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.50
73983589|NCT01292005|147512453|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.58
73874262|NCT03201419|147290616|SUPERIORITY||Mean Difference|0.72||||0.8373|TWO_SIDED|95.0|-6.19|7.63||Threshold for significance at 0.05 level.|MMRM|||||7.63|-6.19|0.8373
73983590|NCT01292005|147512453|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.80
73983591|NCT01292005|147512454|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.90
73983592|NCT01292005|147512454|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.56
73983593|NCT01292005|147512455|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||p\<0.05 was considered statistically significant.||||0.09
73983594|NCT01292005|147512456|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||p\<0.05 was considered statistically significant.||||0.22
73983595|NCT01292005|147512457|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Comparison between arms for length of hospitalization \> 4 days. P \< 0.05 was considered statistically significant.||||0.04
73983596|NCT01292005|147512457|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||Comparison was for length of hospitalization \>10 days. P \< 0.05 was considered statistically significant.||||0.03
73983597|NCT01292005|147512458|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||P \< 0.05 was considered statistically significant.||||0.06
73983598|NCT01292005|147512459|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||P \< 0.05 was considered statistically significant.||||0.03
73983599|NCT01292005|147512460|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||P \< 0.05 was considered statistically significant.||||0.04
73983600|NCT00321672|147512467|SUPERIORITY_OR_OTHER|||||||0.0967||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||The null hypothesis was that there was no difference between the average percent change in NPRS scores from baseline to weeks 2-12 between the total control and total NGX-4010 groups. The ratio of means between the 30- and 60-minute control group \[1.57 (90% CI: 1.12-2.35)\] was \> than the pre-specified equivalence margin ratio of 80-125%. Hence, the control groups could not be pooled and comparisons were performed between the 30- and 60-minute NGX-4010 groups and their respective control groups.||||0.0967
73983601|NCT00321672|147512467|SUPERIORITY_OR_OTHER|||||||0.4884||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.4884
73983602|NCT00321672|147512467|SUPERIORITY_OR_OTHER|||||||0.1031||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.1031
74033966|NCT05906732|147620783|SUPERIORITY||Mean Difference (Net)|27.33||||0.2019|TWO_SIDED||||||t-test, 2 sided|||||||0.2019
74033967|NCT05906732|147620784|SUPERIORITY|||||||0.2808|||||||t-test, 2 sided|||||||0.2808
74089635|NCT00754494|147732034|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.083
74089636|NCT02990806|147732043|EQUIVALENCE|A test for equivalence was carried out using an asymmetric margin (-12%, 15%) pre-specified in protocol and a two 1-sided test (TOST) analysis with α=0.05 for each 1-sided statistical test.|Percentage difference|3.6|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-4.3|11.5||||||||11.5|-4.3|
73983603|NCT00321672|147512468|SUPERIORITY_OR_OTHER|||||||0.0831||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 in the absolute change in NPRS scores from Baseline during Weeks 2-12."||||0.0831
73983604|NCT00321672|147512468|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.4680
73983605|NCT00321672|147512468|SUPERIORITY_OR_OTHER|||||||0.0896||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.0896
73983606|NCT00321672|147512469|SUPERIORITY_OR_OTHER|||||||0.0662||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 group in the Proportion of Subjects Reaching 30% Decrease in Their Mean Average Pain for the Past 24 Hours NPRS Score From Baseline During Weeks 2 to 12."||||0.0662
74033968|NCT05906732|147620785|SUPERIORITY||Mean Difference (Net)|110.39||||0.1644|TWO_SIDED||||||t-test, 2 sided|||||||0.1644
74033969|NCT05906732|147620786|SUPERIORITY||Mean Difference (Net)|-44.29||||0.0282|TWO_SIDED||||||t-test, 2 sided|||||||0.0282
74033970|NCT05906732|147620787|SUPERIORITY||Mean Difference (Net)|-37.87||||0.0306|TWO_SIDED||||||t-test, 2 sided|||||||0.0306
74033971|NCT05906732|147620788|SUPERIORITY||Mean Difference (Net)|-53.42||||0.0016|TWO_SIDED||||||t-test, 2 sided|||||||0.0016
74033972|NCT05906732|147620789|SUPERIORITY||Mean Difference (Net)|-44.25||||0.1378|TWO_SIDED||||||t-test, 2 sided|||||||0.1378
74033973|NCT03207022|147620790|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74033974|NCT03207022|147620791|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74033975|NCT03207022|147620792|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73983607|NCT00321672|147512469|SUPERIORITY_OR_OTHER|||||||0.5582||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||||||0.5582
73983608|NCT00321672|147512469|SUPERIORITY_OR_OTHER|||||||0.0553||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||||||0.0553
73983609|NCT02168153|147512478|SUPERIORITY||Mean Difference (Final Values)|-3.49||||0.76|TWO_SIDED|95.0|-25.75|18.77|||ANCOVA|adjusted for age||Between group differences||18.77|-25.75|0.76
73983610|NCT02168153|147512479|SUPERIORITY||Mean Difference (Final Values)|0.97||||0.92|TWO_SIDED|95.0|-18.04|19.98|||ANCOVA|adjusted for age||Between group differences||19.98|-18.04|0.92
73983611|NCT02168153|147512480|SUPERIORITY||Mean Difference (Final Values)|3.49||||0.7|TWO_SIDED|95.0|-14.4|21.39|||ANCOVA|adjusted for age||Between group differences||21.39|-14.4|0.70
73983612|NCT02168153|147512481|SUPERIORITY||Mean Difference (Final Values)|0.988||||0.15|TWO_SIDED|95.0|-0.373|2.349|||ANCOVA|adjusted for age||Between group differences||2.349|-0.373|0.15
73983613|NCT02168153|147512482|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.32|TWO_SIDED|95.0|-1.24|0.41|||ANCOVA|adjusted for age||Between group differences||0.41|-1.24|0.32
73874263|NCT03201419|147290617|SUPERIORITY||Mean Difference|0.53||||0.8646|TWO_SIDED|95.0|-5.54|6.59||Threshold for significance at 0.05 level.|MMRM|||||6.59|-5.54|0.8646
73874264|NCT03201419|147290617|SUPERIORITY||Mean Difference|-6.99||||0.087|TWO_SIDED|95.0|-15.0|1.02||Threshold for significance at 0.05 level.|MMRM|||||1.02|-15.00|0.0870
73983614|NCT01154699|147512511|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 2 sided|||The difference in the change in asthma control during the Usual care and the Bilevel PAP period were compared.||||0.8
73983615|NCT01154699|147512512|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||Change in PC20 between the two arms||||0.20
73983616|NCT01154699|147512513|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
73983617|NCT01154699|147512514|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
73983618|NCT01154699|147512515|SUPERIORITY_OR_OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
73983619|NCT01154699|147512516|SUPERIORITY_OR_OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
73983620|NCT03050372|147512522|EQUIVALENCE|Significance level alpha=0.05; CI=95%.||||||0.329|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for active/sham LFMS are equal; Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SOL for active/sham LFMS are equal Ha: Means differ"||||0.329
73983621|NCT03050372|147512522|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.321|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.321
73983622|NCT03050372|147512522|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.687|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.687
73983623|NCT03050372|147512523|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.925|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline WASO for active/sham LFMS are equal Ha: Means differ"||||0.925
73983624|NCT03050372|147512523|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.08|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.08
73983625|NCT03050372|147512523|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.221|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.221
73874265|NCT03201419|147290617|SUPERIORITY||Mean Difference|2.77||||0.51|TWO_SIDED|95.0|-5.5|11.04||Threshold for significance at 0.05 level.|MMRM|||||11.04|-5.50|0.5100
73874266|NCT03201419|147290617|SUPERIORITY||Mean Difference|7.32||||0.1535|TWO_SIDED|95.0|-2.75|17.39||Threshold for significance at 0.05 level.|MMRM|||||17.39|-2.75|0.1535
73983626|NCT03050372|147512524|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.197|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline TST for active/sham LFMS are equal Ha: Means differ"||||0.197
73983627|NCT03050372|147512524|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.586|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.586
74089637|NCT02654587|147732107|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.05|TWO_SIDED|95.0|0.38|0.91||OS in patients with ICI secondary resistance|t-test, 2 sided||p=0.017|||0.91|0.38|<0.05
74089638|NCT02654587|147732107|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.36|TWO_SIDED|95.0|0.62|1.19|||t-test, 2 sided|||OS in the ITT population with ICI resistance (primary and secondary resistance)||1.19|0.62|0.36
74089639|NCT02654587|147732108|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.004|TWO_SIDED|95.0|0.27|0.79|||t-test, 2 sided|||Post-progression survival in patients with ICI secondary resistance||0.79|0.27|0.004
74089640|NCT02654587|147732108|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0035|TWO_SIDED|95.0|0.39|0.83|||t-test, 2 sided|||Post-progression survival in ITT population with ICI resistance (primary and secondary)||0.83|0.39|0.0035
74089641|NCT02654587|147732109|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.006|TWO_SIDED|95.0|0.23|0.8|||t-test, 2 sided|||Time to worsening ECOG PS \>1 in patients with ICI secondary resistance||0.80|0.23|0.006
73983628|NCT03050372|147512524|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.298|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.298
73983629|NCT03050372|147512525|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.424|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SE for active/sham LFMS are equal Ha: Means differ"||||0.424
73983630|NCT03050372|147512525|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.21|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.210
73983631|NCT03050372|147512525|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.19|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.190
73983632|NCT03050372|147512526|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.535|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline EOS for active/sham LFMS are equal Ha: Means differ"||||0.535
73983633|NCT03050372|147512526|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.196|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.196
73983634|NCT03050372|147512526|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.092|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.092
73983635|NCT03050372|147512527|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||1|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SQS for active/sham LFMS are equal Ha: Means differ"||||1.00
73983636|NCT03050372|147512527|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.004|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.004
73983637|NCT03050372|147512527|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.042|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.042
73983638|NCT03050372|147512528|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.05|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline #awake for active/sham LFMS are equal Ha: Means differ"||||0.05
73983639|NCT03050372|147512528|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.379|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.379
73983640|NCT03050372|147512528|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.284|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.284
73983641|NCT03050372|147512529|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.226|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Fatigue for active/sham LFMS are equal Ha: Means differ"||||0.226
73983642|NCT03050372|147512529|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.156|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.156
73983643|NCT03050372|147512529|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.117|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.117
73983644|NCT03050372|147512530|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.13|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Concentration for active/sham LFMS are equal Ha: Means differ"||||0.130
73983645|NCT03050372|147512530|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.249|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.249
74089642|NCT02654587|147732109|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.02|TWO_SIDED|95.0|0.35|0.92|||t-test, 2 sided|||Time to worsening ECOG PS in the ITT population with ICI resistance (primary and secondary)||0.92|0.35|0.02
73874267|NCT03201419|147290617|SUPERIORITY||Mean Difference|-5.14||||0.3369|TWO_SIDED|95.0|-15.66|5.38||Threshold for significance at 0.05 level.|MMRM|||||5.38|-15.66|0.3369
73874268|NCT03201419|147290617|SUPERIORITY||Mean Difference|0.27||||0.9417|TWO_SIDED|95.0|-7.05|7.59||Threshold for significance at 0.05 level.|MMRM|||||7.59|-7.05|0.9417
73874269|NCT03201419|147290618|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-1.41|5.47||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||5.47|-1.41|
73983646|NCT03050372|147512530|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.114|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.114
73983647|NCT00331799|147512543|SUPERIORITY_OR_OTHER|||||||0.00365|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Signed Rank test on the difference between the baseline and endpoint score on the CD-RISC.||||0.00365
73983648|NCT05065918|147512544|SUPERIORITY||Slope|-0.536||||0.448|TWO_SIDED|95.0|-1.929|0.857|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||0.857|-1.929|0.448
73983649|NCT05065918|147512545|SUPERIORITY||Slope|0.99||||0.969|TWO_SIDED|95.0|-1.152|1.108|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.108|-1.152|0.969
73983650|NCT05065918|147512546|SUPERIORITY||Slope|-0.5||||0.231|TWO_SIDED|95.0|-1.322|0.322|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.322|-1.322|0.231
73983651|NCT05065918|147512547|SUPERIORITY||Slope|-0.319||||0.398|TWO_SIDED|95.0|-1.064|0.425|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.425|-1.064|0.398
73983652|NCT05065918|147512548|SUPERIORITY||Slope|0.284||||0.382|TWO_SIDED|95.0|-0.356|0.924|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.924|-.356|0.382
73983653|NCT05065918|147512549|SUPERIORITY||Slope|0.382||||0.266|TWO_SIDED|95.0|-0.284|1.025|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.025|-.284|0.266
73983654|NCT05065918|147512550|SUPERIORITY||Slope|0.53||||0.019|TWO_SIDED|95.0|0.089|0.97|||Regression, Linear|||||.970|0.089|0.019
73983655|NCT05065918|147512551|SUPERIORITY||Slope|0.277||||0.284|TWO_SIDED|95.0|-0.232|0.787|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||0.787|-.232|0.284
73874270|NCT03201419|147290618|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.43|1.19||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.19|-0.43|
74009205|NCT00397033|147569183|SUPERIORITY_OR_OTHER||LS Means Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.083||95.0|-0.6|0.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.0|-0.6|0.083
73874271|NCT03201419|147290618|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.16|0.5||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.50|-0.16|
73874272|NCT03201419|147290618|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.03|0.15||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.15|-0.03|
73874273|NCT03201419|147290618|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.01|0.05||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.05|-0.01|
73874274|NCT03201419|147290618|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.01|-0.00|
73874275|NCT03201419|147290619|SUPERIORITY||Mean Difference|5.2||||0.3328|TWO_SIDED|95.0|-5.3|15.7||Threshold for significance at 0.05 level.|ANCOVA|||||15.7|-5.3|0.3328
73874276|NCT03201419|147290619|SUPERIORITY||Mean Difference|15.5||||0.0255|TWO_SIDED|95.0|1.9|29.2||Threshold for significance at 0.05 level.|ANCOVA|||||29.2|1.9|0.0255
73874277|NCT03201419|147290619|SUPERIORITY||Mean Difference|2.5||||0.7296|TWO_SIDED|95.0|-11.7|16.7||Threshold for significance at 0.05 level.|ANCOVA|||||16.7|-11.7|0.7296
73874278|NCT03201419|147290619|SUPERIORITY||Mean Difference|-6.7||||0.4586|TWO_SIDED|95.0|-24.5|11.1||Threshold for significance at 0.05 level.|ANCOVA|||||11.1|-24.5|0.4586
73983656|NCT05065918|147512552|SUPERIORITY||Slope|0.709||||0.076|TWO_SIDED|95.0|-0.076|1.494|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.494|-.076|0.076
73983657|NCT05065918|147512553|SUPERIORITY||Slope|0.625||||0.136|TWO_SIDED|95.0|-0.199|1.449|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.449|-.199|0.136
73983658|NCT03149887|147512556|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
73983659|NCT03149887|147512557|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
73983660|NCT03149887|147512558|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
73983661|NCT03149887|147512559|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
73874279|NCT03201419|147290619|SUPERIORITY||Mean Difference|11.2||||0.2327|TWO_SIDED|95.0|-7.2|29.5||Threshold for significance at 0.05 level.|ANCOVA|||||29.5|-7.2|0.2327
73874280|NCT03201419|147290619|SUPERIORITY||Mean Difference|-0.6||||0.924|TWO_SIDED|95.0|-13.3|12.1||Threshold for significance at 0.05 level.|ANCOVA|||||12.1|-13.3|0.9240
73983662|NCT03149887|147512560|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
73983663|NCT03149887|147512561|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
73983664|NCT03149887|147512562|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
73983665|NCT03149887|147512563|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
73983666|NCT03034772|147512582|SUPERIORITY|||||||0.04|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.04
73983667|NCT03034772|147512583|SUPERIORITY|||||||0.11|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.11
73983668|NCT03034772|147512584|SUPERIORITY|||||||0.01|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.01
73983669|NCT03034772|147512585|SUPERIORITY|||||||0.78|||||||ANCOVA|||||||0.78
73983670|NCT03034772|147512586|SUPERIORITY|||||||0.24|||||||ANCOVA|||||||0.24
73983671|NCT01533181|147512614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.9||||0.0001|TWO_SIDED|95.0|1.9|8.1|||Kaplan-Meier|||||8.1|1.9|0.0001
73983672|NCT01533181|147512617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.71|TWO_SIDED|95.0|0.6|2.2|||Kaplan-Meier|||||2.2|0.6|0.71
73983673|NCT01837719|147512624|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (fixed-dose combination \[FDC\] tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC\[0-T\]) and AUC from time 0 to infinity. (AUC\[0-T\])|Geometric mean ratio|1.073|||||TWO_SIDED|90.0|1.012|1.137|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax, with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.||1.137|1.012|
73983674|NCT01837719|147512624|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.423|||||TWO_SIDED|90.0|1.273|1.59|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.590|1.273|
73983675|NCT01837719|147512624|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.137|||||TWO_SIDED|90.0|1.0|1.292|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.292|1.000|
73983676|NCT01837719|147512624|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.862|||||TWO_SIDED|90.0|0.701|1.059|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.059|0.701|
73874281|NCT03201419|147290620|SUPERIORITY||Mean Difference|0.3||||0.9499|TWO_SIDED|95.0|-7.9|8.5||Threshold for significance at 0.05 level.|ANCOVA|||||8.5|-7.9|0.9499
73874282|NCT03201419|147290620|SUPERIORITY||Mean Difference|5.8||||0.2842|TWO_SIDED|95.0|-4.8|16.4||Threshold for significance at 0.05 level.|ANCOVA|||||16.4|-4.8|0.2842
73874283|NCT03201419|147290620|SUPERIORITY||Mean Difference|-5.7||||0.31|TWO_SIDED|95.0|-16.8|5.4||Threshold for significance at 0.05 level.|ANCOVA|||||5.4|-16.8|0.3100
73983677|NCT01837719|147512624|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.643|||||TWO_SIDED|90.0|0.545|0.759|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC||0.759|0.545|
74033976|NCT02336594|147620793|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio (%)|107.0|||||TWO_SIDED|90.0|95.2|120.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||120|95.2|
74089643|NCT02654587|147732110|SUPERIORITY||P Value|0.045|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||QLQ C30 Global Health Status in Patients with ICI secondary resistance||||<0.05
74089644|NCT02654587|147732110|SUPERIORITY||P Value|0.07||||0.07|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Physical functioning in patients with ICI secondary resistance||||0.07
74089645|NCT02654587|147732110|SUPERIORITY||P Value|0.03|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Role functioning in patients with ICI secondary resistance||||<0.05
74089646|NCT02654587|147732110|SUPERIORITY||P Value|0.36||||0.36|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Emotional functioning in patients with ICI secondary resistance||||0.36
73983678|NCT01837719|147512625|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.|Geometric mean ratio|1.065|||||TWO_SIDED|90.0|1.012|1.12|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) is calculated as Treatment B/Treatment A|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).||1.120|1.012|
73983679|NCT01837719|147512625|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.275|||||TWO_SIDED|90.0|1.166|1.393|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as a random effect was used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC||1.393|1.166|
73983680|NCT01837719|147512625|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.113|||||TWO_SIDED|90.0|0.993|1.248|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect||1.248|0.993|
73874284|NCT03201419|147290620|SUPERIORITY||Mean Difference|-10.1||||0.1499|TWO_SIDED|95.0|-23.9|3.7||Threshold for significance at 0.05 level.|ANCOVA|||||3.7|-23.9|0.1499
73874285|NCT03201419|147290620|SUPERIORITY||Mean Difference|-8.2||||0.2571|TWO_SIDED|95.0|-22.5|6.0||Threshold for significance at 0.05 level.|ANCOVA|||||6.0|-22.5|0.2571
73874286|NCT03201419|147290620|SUPERIORITY||Mean Difference|-1.5||||0.7629|TWO_SIDED|95.0|-11.4|8.3||Threshold for significance at 0.05 level.|ANCOVA|||||8.3|-11.4|0.7629
73874287|NCT03201419|147290621|SUPERIORITY||Mean Difference|2.48||||0.4846|TWO_SIDED|95.0|-4.5|9.46||Threshold for significance at 0.05 level.|MMRM|||||9.46|-4.50|0.4846
73983681|NCT01837719|147512625|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.804|1.122|||Mixed Models Analysis||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC.||1.122|0.804|
73983682|NCT01837719|147512625|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.746|||||TWO_SIDED|90.0|0.655|0.849|||Mixed Models Analysis||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC||0.849|0.655|
74039504|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.0002|TWO_SIDED|95.0|-0.32|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.32|0.0002
74039505|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8348|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.11|0.8348
74039506|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|-0.26|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.26|0.0020
74039507|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.30|0.0001
74039508|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0272|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.25|0.0272
74089647|NCT02654587|147732110|SUPERIORITY||P Value|0.24||||0.24|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Cognitive functioning in patients with ICI secondary resistance||||0.24
74089648|NCT02654587|147732110|SUPERIORITY|QLQ-C30 Social functioning|P Value|0.11||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
74089649|NCT02654587|147732111|SUPERIORITY||P Value|0.06||||0.06|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Fatigue in ICI secondary resistance||||0.06
73874288|NCT03201419|147290621|SUPERIORITY||Mean Difference|-16.93||||0.0004|TWO_SIDED|95.0|-26.26|-7.6||Threshold for significance at 0.05 level.|MMRM|||||-7.60|-26.26|0.0004
73874289|NCT03201419|147290621|SUPERIORITY||Mean Difference|-2.05||||0.6685|TWO_SIDED|95.0|-11.47|7.37||Threshold for significance at 0.05 level.|MMRM|||||7.37|-11.47|0.6685
73874290|NCT03201419|147290621|SUPERIORITY||Mean Difference|1.69||||0.7772|TWO_SIDED|95.0|-10.07|13.46||Threshold for significance at 0.05 level.|MMRM|||||13.46|-10.07|0.7772
73874291|NCT03201419|147290621|SUPERIORITY||Mean Difference|10.67||||0.0895|TWO_SIDED|95.0|-1.66|23.0||Threshold for significance at 0.05 level.|MMRM|||||23.00|-1.66|0.0895
73983683|NCT01837719|147512625|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).|Geometric mean ratio|1.064||||||90.0|1.011|1.12|||Mixed Models Analysis||Geometric mean ration for AUC(INF) is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment period and sequence as fixed effects, and patient (sequence) as a random effect.||1.120|1.011|
73983684|NCT01837719|147512625|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.28|||||TWO_SIDED|90.0|1.171|1.398|||Mixed Models Analysis||Geometric mean ratio for AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of a light meal and fthe fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.398|1.171|
73983685|NCT01837719|147512625|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.11|||||TWO_SIDED|90.0|0.991|1.244|||Mixed Models Analysis||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect||1.244|0.991|
73983686|NCT01837719|147512625|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.956|||||TWO_SIDED|90.0|0.81|1.128|||Mixed Models Analysis||Geometric mean of AUC(INF) was calculated as Treatment E/Treatment D|||1.128|0.810|
73983687|NCT01837719|147512625|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.749|||||TWO_SIDED|90.0|0.658|0.852|||Mixed Models Analysis||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when administered as an FDC.||0.852|0.658|
73983688|NCT01837719|147512630|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.084|||||TWO_SIDED|90.0|1.014|1.158|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.158|1.014|
73874292|NCT03201419|147290621|SUPERIORITY||Mean Difference|1.2||||0.782|TWO_SIDED|95.0|-7.34|9.74|||MMRM|||||9.74|-7.34|0.7820
73983689|NCT01837719|147512630|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.349|||||TWO_SIDED|90.0|1.215|1.498|||Mixed Models Analysis||Geometric mean ratio of C24 was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.498|1.215|
73983690|NCT01837719|147512630|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.144||||||90.0|1.006|1.3|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC||1.300|1.006|
73983691|NCT01837719|147512630|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.231|||||TWO_SIDED|90.0|1.023|1.483|||||Geometric mean ratio was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.483|1.023|
73983692|NCT01837719|147512630|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.912||||||90.0|0.789|1.054|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.054|0.789|
73983693|NCT01837719|147512632|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.023|||||TWO_SIDED|90.0|0.991|1.057|||||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.057|0.991|
73983694|NCT01837719|147512632|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.305|||||TWO_SIDED|90.0|1.215|1.402|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.402|1.215|
73983695|NCT01837719|147512632|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.085|||||TWO_SIDED|90.0|0.925|1.273|||||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir cobicistat||1.273|0.925|
73983696|NCT01837719|147512632|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.937|1.154|||||Geometric mean ratio was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.154|0.937|
73874293|NCT03201419|147290622|SUPERIORITY||Mean Difference|-0.41||||0.9175|TWO_SIDED|95.0|-8.25|7.42||Threshold for significance at 0.05 level.|MMRM|||||7.42|-8.25|0.9175
73983697|NCT01837719|147512632|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.784|||||TWO_SIDED|90.0|0.717|0.858|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||0.858|0.717|
73874294|NCT03201419|147290622|SUPERIORITY||Mean Difference|-4.32||||0.4098|TWO_SIDED|95.0|-14.62|5.98||Threshold for significance at 0.05 level.|MMRM|||||5.98|-14.62|0.4098
73874295|NCT03201419|147290622|SUPERIORITY||Mean Difference|2.41||||0.6566|TWO_SIDED|95.0|-8.25|13.06||Threshold for significance at 0.05 level.|MMRM|||||13.06|-8.25|0.6566
73874296|NCT03201419|147290622|SUPERIORITY||Mean Difference|3.39||||0.6144|TWO_SIDED|95.0|-9.85|16.63||Threshold for significance at 0.05 level.|MMRM|||||16.63|-9.85|0.6144
73874297|NCT03201419|147290622|SUPERIORITY||Mean Difference|3.8||||0.5798|TWO_SIDED|95.0|-9.71|17.31||Threshold for significance at 0.05 level.|MMRM|||||17.31|-9.71|0.5798
73874298|NCT03201419|147290622|SUPERIORITY||Mean Difference|0.35||||0.9417|TWO_SIDED|95.0|-9.17|9.88||Threshold for significance at 0.05 level.|MMRM|||||9.88|-9.17|0.9417
73983698|NCT01837719|147512634|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.983|1.057|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment A|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.057|0.983|
73983699|NCT01837719|147512634|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.232||||||90.0|1.141|1.331|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC||1.331|1.141|
73983700|NCT01837719|147512634|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.102|||||TWO_SIDED|90.0|0.929|1.307|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.307|0.929|
73983701|NCT01837719|147512634|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.127||||||90.0|1.017|1.248|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC.||1.248|1.017|
73983702|NCT01837719|147512634|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.89|||||TWO_SIDED|90.0|0.825|0.96|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and a light meal on the natural logarithms of exposure of cobicistat when given as an FDC||0.960|0.825|
73874299|NCT03201419|147290623|SUPERIORITY||Mean Difference|-2.81||||0.5148|TWO_SIDED|95.0|-11.31|5.68||Threshold for significance at 0.05 level.|MMRM|||||5.68|-11.31|0.5148
73983703|NCT01837719|147512634|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T), and AUC(INF).|Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.982|1.058|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.||1.058|0.982|
73874300|NCT03201419|147290623|SUPERIORITY||Mean Difference|-9.65||||0.0879|TWO_SIDED|95.0|-20.75|1.44||Threshold for significance at 0.05 level.|MMRM|||||1.44|-20.75|0.0879
73874301|NCT03201419|147290623|SUPERIORITY||Mean Difference|3.61||||0.5335|TWO_SIDED|95.0|-7.79|15.0||Threshold for significance at 0.05 level.|MMRM|||||15.00|-7.79|0.5335
73983704|NCT01837719|147512634|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|1.148|1.34|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC||1.340|1.148|
73874302|NCT03201419|147290623|SUPERIORITY||Mean Difference|6.29||||0.3787|TWO_SIDED|95.0|-7.76|20.34||Threshold for significance at 0.05 level.|MMRM|||||20.34|-7.76|0.3787
73983705|NCT01837719|147512634|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.976|||||TWO_SIDED|90.0|0.886|1.075|||||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.075|0.886|
74089650|NCT02654587|147732111|SUPERIORITY||P Value|0.0003||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Constipation in ICI secondary resistance||||0.0003
73874303|NCT03201419|147290623|SUPERIORITY||Mean Difference|1.48||||0.8448|TWO_SIDED|95.0|-13.41|16.38||Threshold for significance at 0.05 level.|MMRM|||||16.38|-13.41|0.8448
73874304|NCT03201419|147290623|SUPERIORITY||Mean Difference|4.62||||0.3751|TWO_SIDED|95.0|-5.63|14.87||Threshold for significance at 0.05 level.|MMRM|||||14.87|-5.63|0.3751
73874305|NCT03201419|147290624|SUPERIORITY||Mean Difference|-0.43||||0.9245|TWO_SIDED|95.0|-9.43|8.57||Threshold for significance at 0.05 level.|MMRM|||||8.57|-9.43|0.9245
73874306|NCT03201419|147290624|SUPERIORITY||Mean Difference|-6.72||||0.2657|TWO_SIDED|95.0|-18.59|5.15||Threshold for significance at 0.05 level.|MMRM|||||5.15|-18.59|0.2657
73874307|NCT03201419|147290624|SUPERIORITY||Mean Difference|9.2||||0.1383|TWO_SIDED|95.0|-2.99|21.38||Threshold for significance at 0.05 level.|MMRM|||||21.38|-2.99|0.1383
73874308|NCT03201419|147290624|SUPERIORITY||Mean Difference|14.72||||0.0523|TWO_SIDED|95.0|-0.15|29.59||Threshold for significance at 0.05 level.|MMRM|||||29.59|-0.15|0.0523
73874309|NCT03201419|147290624|SUPERIORITY||Mean Difference|1.14||||0.8855|TWO_SIDED|95.0|-14.47|16.75||Threshold for significance at 0.05 level.|MMRM|||||16.75|-14.47|0.8855
73874310|NCT03201419|147290624|SUPERIORITY||Mean Difference|2.91||||0.5972|TWO_SIDED|95.0|-7.91|13.72||Threshold for significance at 0.05 level.|MMRM|||||13.72|-7.91|0.5972
73874311|NCT03201419|147290625|SUPERIORITY||Mean Difference|-0.54|||||TWO_SIDED|95.0|-6.09|2.28||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.28|-6.09|
73874312|NCT03201419|147290625|SUPERIORITY||Mean Difference|-0.28|||||TWO_SIDED|95.0|-4.3|0.75||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.75|-4.30|
73874313|NCT03201419|147290625|SUPERIORITY||Mean Difference|-0.15|||||TWO_SIDED|95.0|-2.44|0.33||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.33|-2.44|
73874314|NCT03201419|147290625|SUPERIORITY||Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.92|0.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.07|-0.92|
73983706|NCT01837719|147512634|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.116|||||TWO_SIDED|90.0|1.012|1.231|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and fasted on the natural logarithms of exposure of cobicistat when given as an FDC.||1.231|1.012|
73983707|NCT01837719|147512634|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.904|||||TWO_SIDED|90.0|0.836|0.978|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and light meal on the natural logarithms of exposure of atazanavir when given as an FDC||0.978|0.836|
73874315|NCT03201419|147290625|SUPERIORITY||Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.48|0.02||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.02|-0.48|
73874316|NCT03201419|147290625|SUPERIORITY||Mean Difference|0.0|||||TWO_SIDED|95.0|-0.15|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.00|-0.15|
73983708|NCT02995733|147512646|SUPERIORITY|Asthma exacerbation rates during follow-up between two randomized treatment arms are compared using the Andersen-Gill adaptation of time-to-event Cox proportional hazard model with robust standard errors to account for multiple occurrences of the outcome in each patient (Andersen Gill, 1982). This analysis is based on intention-to-treat (ITT) patient population.|Cox Proportional Hazard|0.85||||0.048|TWO_SIDED|95.0|0.72|0.999|||Cox proportional hazard model|Pre-specified baseline covariates are adjusted in the model. A time-dependent covariate for the COVID pandemic is also included in adjustments.||||0.999|0.720|0.048
74033977|NCT02336594|147620795|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|97.3|||||TWO_SIDED|90.0|85.6|111.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||111|85.6|
74033978|NCT02336594|147620796|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|100.0|||||TWO_SIDED|90.0|87.3|115.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||115|87.3|
74033979|NCT02336594|147620798|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|182.0|||||TWO_SIDED|90.0|144.0|230.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||230|144|
74033980|NCT02336594|147620799|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|140.0|||||TWO_SIDED|90.0|121.0|163.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||163|121|
73874317|NCT03201419|147290626|SUPERIORITY||Mean Difference|-0.27||||0.055|TWO_SIDED|95.0|-0.545|0.006||Threshold for significance at 0.05 level.|MMRM|||||0.006|-0.545|0.0550
73874318|NCT03201419|147290626|SUPERIORITY||Mean Difference|-0.7||||0.0002|TWO_SIDED|95.0|-1.066|-0.335||Threshold for significance at 0.05 level.|MMRM|||||-0.335|-1.066|0.0002
73874319|NCT03201419|147290626|SUPERIORITY||Mean Difference|-0.037||||0.844|TWO_SIDED|95.0|-0.404|0.33||Threshold for significance at 0.05 level.|MMRM|||||0.330|-0.404|0.8440
73874320|NCT03201419|147290626|SUPERIORITY||Mean Difference|0.041||||0.861|TWO_SIDED|95.0|-0.417|0.498||Threshold for significance at 0.05 level.|MMRM|||||0.498|-0.417|0.8610
73874321|NCT03201419|147290626|SUPERIORITY||Mean Difference|0.036||||0.8871|TWO_SIDED|95.0|-0.46|0.532||Threshold for significance at 0.05 level.|MMRM|||||0.532|-0.460|0.8871
74033981|NCT02336594|147620800|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|134.0|||||TWO_SIDED|90.0|114.0|156.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||156|114|
74033982|NCT02336594|147620801|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|79.1|||||TWO_SIDED|90.0|66.4|94.2|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||94.2|66.4|
74033983|NCT02336594|147620802|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|85.5|||||TWO_SIDED|90.0|73.9|98.8|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||98.8|73.9|
74033984|NCT02336594|147620803|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|83.4|||||TWO_SIDED|90.0|73.5|94.7|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||94.7|73.5|
74033985|NCT04490265|147620816|SUPERIORITY||Cohen's d|0.33|||||TWO_SIDED|||||||||||||
74033986|NCT04490265|147620817|SUPERIORITY||Cohen's d|0.78|||||TWO_SIDED|||||||||||||
74033987|NCT04490265|147620822|SUPERIORITY||Cohen's d|0.14|||||TWO_SIDED|||||||||Belonging Subscale change from baseline to 12-weeks||||
74033988|NCT04490265|147620822|SUPERIORITY||Cohen's D|0.05|||||TWO_SIDED|||||||||Belonging subscale Baseline to 6-months||||
74033989|NCT04490265|147620822|SUPERIORITY||Cohen's D|0.6|||||TWO_SIDED|||||||||Change in Burdensome subscale Baseline to 12-weeks||||
74033990|NCT04490265|147620822|SUPERIORITY||Cohen's D|0.43|||||TWO_SIDED|||||||||Change in Burdensome subscale Baseline to 6 months||||
74033991|NCT04490265|147620823|SUPERIORITY||Cohen's D|0.07|||||TWO_SIDED|||||||||Baseline to 12-weeks||||
74033992|NCT04490265|147620823|SUPERIORITY||Cohen's D|0.13|||||TWO_SIDED|||||||||Baseline to 6-months||||
74033993|NCT04490265|147620824|SUPERIORITY||Cohen's d|0.6|||||TWO_SIDED|||||||||||||
73983709|NCT02995733|147512647|SUPERIORITY|Mixed model is used to compare the treatment effects. The response variable is ACT change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.|Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
73983710|NCT02995733|147512648|SUPERIORITY|Mixed model is used to compare the treatment effects. The response variable is ASUI change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.|Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|0.02|0.05||||||||0.05|0.02|
73983711|NCT02995733|147512649|SUPERIORITY|Negative binomial regression model is used, with time as an offset to account for differential duration of follow-up. The model adjusts for all the baseline covariates included in the primary analysis.|Rate ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95||||||||0.95|0.67|
73983712|NCT04879823|147512650|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||Null hypothesis: Average pain scores before medication will not be lower in the dexamethasone group compared with the placebo group.||||0.03
73983713|NCT04879823|147512651|SUPERIORITY|||||||0.07|||||||Fisher Exact|||Null hypothesis: There will be no difference in the proportion of patients visiting the emergency department or urgent care (at least 1 time) post-operatively between dexamethasone and placebo groups.||||0.07
73983714|NCT04879823|147512652|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: Average pain scores after medication will not be lower in the dexamethasone group compared with the placebo group.||||0.98
73983715|NCT04468633|147512666|OTHER|||||||0.687|||||||t-test, 2 sided|||Baseline||||0.687
73983716|NCT04468633|147512666|OTHER|||||||0.384|||||||t-test, 2 sided|||Day 1||||0.384
73983717|NCT04468633|147512666|OTHER|||||||0.597|||||||t-test, 2 sided|||Week 1||||0.597
73983718|NCT04468633|147512666|OTHER|||||||0.86|||||||t-test, 2 sided|||Week 4||||0.860
73983719|NCT04468633|147512666|OTHER|||||||0.032|||||||t-test, 2 sided|||Week 6||||0.032
73983720|NCT04468633|147512666|OTHER|||||||0.026|||||||t-test, 2 sided|||Month 3||||0.026
73983721|NCT04468633|147512666|OTHER|||||||0.172|||||||t-test, 2 sided|||Month 6||||0.172
73983722|NCT04468633|147512666|OTHER|||||||0.01|||||||t-test, 2 sided|||Year 1||||0.010
73983723|NCT04468633|147512670|OTHER|||||||0.759|||||||Wilcoxon rank sum test|||||||0.759
73983724|NCT04468633|147512671|OTHER|||||||0.603|||||||Wilcoxon rank sum test|||||||0.603
73983725|NCT04468633|147512680|OTHER|||||||0.833|||||||Wilcoxon rank sum test|||||||0.833
73983726|NCT01469819|147512725|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73983727|NCT01469819|147512726|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73983728|NCT01469819|147512727|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73983729|NCT01469819|147512728|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73983730|NCT04057937|147512730|SUPERIORITY||Percentage Difference:Apremilast-Placebo|37.4||||0.0003|TWO_SIDED|95.0|18.6|56.1||Two-sided 0.10 significant level|Chi-squared||Confidence Intervals calculated using the Wald method (normal approximation).|||56.1|18.6|0.0003
73983731|NCT02446912|147512742|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|-4.2||||0.412|TWO_SIDED|95.0|-14.2|5.8||Nominal p-value|Cochran-Mantel-Haenszel|||||5.8|-14.2|0.412
73983732|NCT02446912|147512742|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-14.7|9.6||||||||9.6|-14.7|
73983733|NCT02446912|147512743|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|3.9||||0.455|TWO_SIDED|95.0|-6.3|14.1||Nominal p-value|Cochran-Mantel-Haenszel|||||14.1|-6.3|0.455
73983734|NCT02446912|147512743|SUPERIORITY||Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0|-6.7|17.8||||||||17.8|-6.7|
73983735|NCT02446912|147512744|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|-3.4||||0.549|TWO_SIDED|95.0|-14.4|7.6||Nominal p-value|Cochran-Mantel-Haenszel|||||7.6|-14.4|0.549
73983736|NCT02446912|147512745|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|6.4||||0.261|TWO_SIDED|95.0|-4.8|17.7||Nominal p-value|Cochran-Mantel-Haenszel|||||17.7|-4.8|0.261
73983737|NCT02446912|147512746|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|8.9||||0.18|TWO_SIDED|95.0|-4.1|21.9||Nominal p-value|Cochran-Mantel-Haenszel|||||21.9|-4.1|0.180
74033994|NCT04490265|147620825|SUPERIORITY||Cohen's d|0.52|||||TWO_SIDED|||||||||||||
74033995|NCT04490265|147620826|SUPERIORITY||Cohen's d|0.21|||||TWO_SIDED|||||||||||||
74033996|NCT04490265|147620827|SUPERIORITY||Cohen's d|0.2|||||TWO_SIDED|||||||||||||
74033997|NCT04490265|147620828|SUPERIORITY||Cohen's d|0.66|||||TWO_SIDED|||||||||||||
74033998|NCT04490265|147620829|SUPERIORITY||cohen's d|0.38|||||TWO_SIDED|||||||||||||
73983738|NCT02446912|147512747|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.7||||0.013|TWO_SIDED|95.0|3.5|29.8||Nominal p-value|Cochran-Mantel-Haenszel|||||29.8|3.5|0.013
73983739|NCT02446912|147512748|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|17.0||||0.054|TWO_SIDED|95.0|-0.3|34.3||Nominal p-value|Cochran-Mantel-Haenszel|||||34.3|-0.3|0.054
73983740|NCT02446912|147512749|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|18.7||||0.034|TWO_SIDED|95.0|1.4|36.0||Nominal p-value|Cochran-Mantel-Haenszel|||||36.0|1.4|0.034
73983741|NCT02446912|147512750|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|0.6||||0.905|TWO_SIDED|95.0|-9.4|10.6||Nominal p-value|Cochran-Mantel-Haenszel|||||10.6|-9.4|0.905
73983742|NCT02446912|147512751|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|3.3||||0.515|TWO_SIDED|95.0|-6.7|13.4||Nominal p-value|Cochran-Mantel-Haenszel|||||13.4|-6.7|0.515
73983743|NCT02446912|147512752|SUPERIORITY|Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>=10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]). The logarithm of the follow-up time is used as an offset variable.|Rate Ratio|0.83||||0.258|TWO_SIDED|95.0|0.6|1.14||Nominal p-value|Negative binomial regression|||||1.14|0.60|0.258
73983744|NCT02446912|147512753|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|0.6|19.7|||Cochran-Mantel-Haenszel|||||19.7|0.6|
73983745|NCT02446912|147512754|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.4|||||TWO_SIDED|95.0|6.7|26.2|||Cochran-Mantel-Haenszel|||||26.2|6.7|
73874322|NCT03201419|147290626|SUPERIORITY||Mean Difference|0.013||||0.9396|TWO_SIDED|95.0|-0.313|0.338||Threshold for significance at 0.05 level.|MMRM|||||0.338|-0.313|0.9396
73983746|NCT00147745|147512764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5499||95.0|-0.1|0.19|||ANCOVA|||||0.19|-0.10|0.5499
73983747|NCT00147745|147512764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.5723||95.0|-0.23|0.13|||ANCOVA|||||0.13|-0.23|0.5723
73983748|NCT00147745|147512764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.091||0.3138||95.0|-0.09|0.28|||ANCOVA|||||0.28|-0.09|0.3138
73983749|NCT00147745|147512765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.065||0.2042||95.0|-0.05|0.22|||ANCOVA|||||0.22|-0.05|0.2042
74033999|NCT04490265|147620830|SUPERIORITY||Cohens d|0.47|||||TWO_SIDED|||||||||Severity||||
73874323|NCT03201419|147290627|SUPERIORITY||Mean Difference|-0.475||||0.005|TWO_SIDED|95.0|-0.806|-0.145||Threshold for significance at 0.05 level.|MMRM|||||-0.145|-0.806|0.0050
73983750|NCT00147745|147512765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.083||0.6855||95.0|-0.2|0.14|||ANCOVA|||||0.14|-0.20|0.6855
73983751|NCT00147745|147512765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.085||0.1727||95.0|-0.05|0.29|||ANCOVA|||||0.29|-0.05|0.1727
73983752|NCT00147745|147512766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.4|STANDARD_ERROR_OF_MEAN|53.17||0.4104||95.0|-152.8|64.1|||ANCOVA|||||64.1|-152.8|0.4104
73983753|NCT00147745|147512766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|69.98||0.8857||95.0|-132.6|152.9|||ANCOVA|||||152.9|-132.6|0.8857
73983754|NCT00147745|147512766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.5|STANDARD_ERROR_OF_MEAN|67.08||0.4226||95.0|-191.3|82.3|||ANCOVA|||||82.3|-191.3|0.4226
73983755|NCT00147745|147512767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.366||0.2286||95.0|-1.2|0.3|||ANCOVA|||||0.30|-1.20|0.2286
74034000|NCT04490265|147620830|SUPERIORITY||Cohens d|0.46|||||TWO_SIDED|||||||||interference||||
73874324|NCT03201419|147290627|SUPERIORITY||Mean Difference|-0.405||||0.0665|TWO_SIDED|95.0|-0.837|0.028||Threshold for significance at 0.05 level.|MMRM|||||0.028|-0.837|0.0665
73874325|NCT03201419|147290627|SUPERIORITY||Mean Difference|-0.149||||0.5245|TWO_SIDED|95.0|-0.608|0.31||Threshold for significance at 0.05 level.|MMRM|||||0.310|-0.608|0.5245
74034001|NCT04490265|147620831|SUPERIORITY||Cohens d|0.64|||||TWO_SIDED|||||||||Severity Subscale||||
74034002|NCT04490265|147620831|SUPERIORITY||Cohen's d|0.38|||||TWO_SIDED|||||||||Interference subscale||||
74089651|NCT02654587|147732111|SUPERIORITY||P Value|0.8||||0.8|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Dyspnea in ICI secondary resistance||||0.80
73983756|NCT00147745|147512767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.515||0.3184||95.0|-0.53|1.57|||ANCOVA|||||1.57|-0.53|0.3184
73983757|NCT00147745|147512767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.5||0.0613||95.0|-1.99|0.05|||ANCOVA|||||0.05|-1.99|0.0613
73983758|NCT00147745|147512768|SUPERIORITY_OR_OTHER|||||||0.0362||95.0|||||t-test, 2 sided|||||||0.0362
73983759|NCT02389725|147512782|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
73983760|NCT02389725|147512783|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
73983761|NCT02389725|147512784|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
73983762|NCT02389725|147512785|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
74034003|NCT00962000|147620841|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.02217|||TWO_SIDED|95.0|-0.064|0.024||There is no p values because the power calculation is based on the primary outcome variable|ANOVA|The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.024|-0.064|
74089652|NCT02654587|147732111|SUPERIORITY||P Value|0.21||||0.21|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Nausea and Vomiting in ICI secondary resistance||||0.21
73874326|NCT03201419|147290627|SUPERIORITY||Mean Difference|-0.075||||0.7947|TWO_SIDED|95.0|-0.642|0.492||Threshold for significance at 0.05 level.|MMRM|||||0.492|-0.642|0.7947
73874327|NCT03201419|147290627|SUPERIORITY||Mean Difference|-0.211||||0.4625|TWO_SIDED|95.0|-0.777|0.355||Threshold for significance at 0.05 level.|MMRM|||||0.355|-0.777|0.4625
73983763|NCT00724750|147512788|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5%/day. For 80% power and a significance (alpha) level of 0.05; and assuming a common standard deviation of 9%, 41 subjects per group were needed.||||||0.6|TWO_SIDED|||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction in the model.|Mixed Models Analysis|||||||0.60
73983764|NCT00724750|147512789|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5%/day.||||||0.19|TWO_SIDED|||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction.|Mixed Models Analysis|||||||0.19
73983765|NCT00724750|147512791|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73983766|NCT00724750|147512792|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
73983767|NCT00724750|147512793|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73983768|NCT00422162|147512797|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||P-value for Change from Baseline. A priori alpha threshold was 0.05 with no adjustment for multiple testing.|ANCOVA|ANCOVA with stratification factors (country and pretreatment for MDD) and MADRS baseline as covariates and treatment regimen as the main factor.||||||0.88
73983769|NCT00422162|147512807|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||<0.0001
73874328|NCT03201419|147290627|SUPERIORITY||Mean Difference|-0.014||||0.9465|TWO_SIDED|95.0|-0.412|0.385||Threshold for significance at 0.05 level.|MMRM|||||0.385|-0.412|0.9465
73983770|NCT00422162|147512807|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||0.001
73983771|NCT00422162|147512807|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||<0.0001
73983772|NCT00422162|147512807|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||0.28
73983773|NCT01357564|147512864|SUPERIORITY||Mean Difference (Net)|-0.72||||0.02|TWO_SIDED|95.0|-1.23|-0.13|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.||-0.13|-1.23|.02
73983774|NCT01357564|147512865|SUPERIORITY||Mean Difference (Net)|-0.1||||0.03|TWO_SIDED|95.0|-0.14|-0.01|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.||-0.01|-0.14|.03
73983775|NCT02267746|147512883|EQUIVALENCE|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.|Mean Difference (Net)|0.93|||||TWO_SIDED|90.0|0.86|1.02|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval \[0.80, 1.25\] for the PP population.|||1.02|0.86|
73983776|NCT02267746|147512884|EQUIVALENCE|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.|Mean Difference (Net)|0.96|||||TWO_SIDED|90.0|0.89|1.04|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval \[0.80, 1.25\] for the PP population.|||1.04|0.89|
73983777|NCT02267746|147512885|EQUIVALENCE|Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\] for PP population.|Mean Difference (Net)|-0.073|||||TWO_SIDED|90.0|-0.15|0.004|||||Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\] for the PP population.|Success was defined as an IGA score at Week 12 that was at least two grades less than the baseline assessment. Failure was defined as an IGA score that was the same, higher, or one grade lower than the baseline assessment.||0.004|-0.150|
73983778|NCT01636778|147512932|SUPERIORITY_OR_OTHER||Percentage|88.0|||||TWO_SIDED|95.0|74.0|96.0||||||||96|74|
74089653|NCT02654587|147732111|SUPERIORITY||P Value|0.45||||0.45|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Pain in ICI secondary resistance||||0.45
73983779|NCT03530345|147512990|SUPERIORITY||Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|0.404||0.0111|TWO_SIDED|95.0|-1.89|-0.26||2-sided p-value for testing superiority of neridronic acid 400 mg compared to placebo.|Mixed Models Analysis|The degrees of freedom of the denominator are estimated using the Kenward-Roger approximation.|The primary endpoint estimate was the least squares mean differences of change from baseline in pain NRS (electronic diary) at Week 12 between neridronate and Placebo.|Mixed-effects model for repeated measures (MMRM) defined with baseline pain intensity as covariate, the factors geographic region, week, treatment and treatment-by-week as fixed effects, and an unstructured covariance matrix to model the covariance structure of the repeated measurements.||-0.26|-1.89|0.0111
73983780|NCT00318591|147513006|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The additional explanatory variables were removed using backwards-elimination removing the least significant additional variable for each iteration, until the effect of all included additional variables was significant on α=0.05 significant level. The null-hypothesis of no catheter difference was to be rejected on α=0.05 significant level.|Hazard Ratio (HR)|1.502||||0.0383|TWO_SIDED|95.0|1.022|2.207||p-value is adjusted for the following explanatory variables: catheterization frequency, technique (clean/sterile), procedure (participant/nurse), setting (hospital/community) and demographic measures.|Kaplan-Meier|||The analysis was done by comparing Kaplan-Meier estimates of the survival function of the two groups. The analysis was refined by a Cox proportional hazards regression model for survival data.||2.207|1.022|0.0383
73983781|NCT00318591|147513008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA analysis. Limit of significant difference \<0.05||||||0.767||95.0||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA|||||||0.7670
73983782|NCT00318591|147513009|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA. Level of significant difference \<0.05||||||0.0074||95.0||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA|||||||0.0074
73983783|NCT04853394|147513013|SUPERIORITY||Risk Ratio (RR)|0.33|||<|0.01|TWO_SIDED|95.0|0.21|0.51|||Mixed Models Analysis|Mixed effects modified Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.51|.21|<.01
73983784|NCT04853394|147513014|SUPERIORITY||Risk Ratio (RR)|0.67||||0.01|TWO_SIDED|95.0|0.46|0.97|||Mixed Models Analysis|Mixed effects modified Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.97|.46|.01
73983785|NCT04853394|147513015|SUPERIORITY||Risk Ratio (RR)|0.86||||0.01|TWO_SIDED|95.0|0.77|0.95|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 6-month follow-up|||.95|.77|.01
73983786|NCT04853394|147513015|SUPERIORITY||Risk Ratio (RR)|1.19||||0.01|TWO_SIDED|95.0|0.98|1.45|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||1.45|.98|.01
74039509|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0009|TWO_SIDED|95.0|-0.31|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.31|0.0009
73874329|NCT03201419|147290628|SUPERIORITY||Mean Difference|-0.73|||<|0.0001|TWO_SIDED|95.0|-1.078|-0.383||Threshold for significance at 0.05 level.|MMRM|||||-0.383|-1.078|<0.0001
73983787|NCT04853394|147513018|SUPERIORITY||Risk Ratio (RR)|0.12||||0.01|TWO_SIDED|95.0|0.07|0.19|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.19|.07|.01
73983788|NCT01184755|147513019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.561256|STANDARD_ERROR_OF_MEAN|0.216403||0.01|TWO_SIDED|95.0|-0.987999|-0.134513||This is an intention-to-treat analysis|Mixed effects regression analysis|||This is the change in Systolic BP at 8 weeks||-.134513|-.987999|.01
73983789|NCT01184755|147513019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.391195|STANDARD_ERROR_OF_MEAN|0.140034||0.006|TWO_SIDED|95.0|-0.667312|-0.115079|||mixed effects regression analysis|||This is the analysis of change in diastolic BP from Ambulatory BP monitoring.||-.115079|-.667312|.006
73983790|NCT01612221|147513058|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||.65
73983791|NCT01612221|147513059|SUPERIORITY|||||||0.76|||||||ANCOVA|||GCLM Biomarker analysis.||||0.76
73983792|NCT01612221|147513059|SUPERIORITY|||||||0.63|||||||ANCOVA|||SLC1A4 Biomarker analysis.||||0.63
73983793|NCT01612221|147513059|SUPERIORITY|||||||0.27|||||||ANCOVA|||SLC7A11 Biomarker analysis.||||0.27
73983794|NCT01044901|147513076|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
73983795|NCT01044901|147513077|OTHER||||||<|0.0001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney test).||||<0.0001
73983796|NCT01044901|147513078|OTHER|||||||0.0137|||||||t-test, 2 sided|P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0137
73983797|NCT01044901|147513079|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
73874330|NCT03201419|147290628|SUPERIORITY||Mean Difference|-0.686||||0.003|TWO_SIDED|95.0|-1.137|-0.236||Threshold for significance at 0.05 level.|MMRM|||||-0.236|-1.137|0.0030
73874331|NCT03201419|147290628|SUPERIORITY||Mean Difference|-0.045||||0.852|TWO_SIDED|95.0|-0.517|0.427||Threshold for significance at 0.05 level.|MMRM|||||0.427|-0.517|0.8520
73983798|NCT01044901|147513080|OTHER|||||||0.16||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.16
73983799|NCT01044901|147513081|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
73983800|NCT01044901|147513082|OTHER|||||||0.0011||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0011
73983801|NCT01044901|147513083|OTHER|||||||0.1||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.10
73983802|NCT01044901|147513084|OTHER|||||||0.48||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.48
73983803|NCT01044901|147513085|OTHER|||||||0.08||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Fisher Exact|||Primary outcome was presented as frequencies and percentages, and then analyzed with a Fisher exact test.||||0.08
74034004|NCT00962000|147620842|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.01849|||TWO_SIDED|95.0|-0.051|0.023||There is no p value for eKt/V because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.|ANOVA|The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.023|-0.051|
74034005|NCT00962000|147620843|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.03103||||95.0|-0.029|0.099||There is no p value for Kt/VID because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.|ANOVA|||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.099|-0.029|
74034006|NCT03280550|147620869|SUPERIORITY||Difference in Least Squares Means|-1.14|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.59|-0.69||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.69|-1.59|<0.0001
74089654|NCT02654587|147732111|SUPERIORITY||P Value|0.87||||0.87|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Insomnia in ICI secondary resistance||||0.87
73983804|NCT01044901|147513086|OTHER|||||||0.91||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.91
73983805|NCT01044901|147513087|OTHER|||||||0.0038||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0038
73983806|NCT01044901|147513088|OTHER|||||||0.034||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.034
73983807|NCT01044901|147513089|OTHER|||||||0.25||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Fisher Exact|||Primary outcome was presented was as frequencies and percentages, and then analyzed with a Fisher exact test.||||0.25
73983808|NCT01044901|147513090|OTHER|||||||0.0288||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0288
74089655|NCT02654587|147732111|SUPERIORITY||P Value|0.59||||0.59|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Appetite loss in ICI secondary resistance||||0.59
74089656|NCT02654587|147732111|SUPERIORITY||P Value|0.88||||0.88|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Diarrhea in ICI secondary resistance||||0.88
74089657|NCT02654587|147732111|SUPERIORITY||P Value|0.37||||0.37|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Financial difficulties in ICI secondary resistance||||0.37
74034007|NCT03280550|147620870|SUPERIORITY||Difference in Least Squares Means|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|95.0|-0.84|-0.25||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.25|-0.84|0.0004
74034008|NCT03280550|147620871|SUPERIORITY||Difference in Least Squares Means|-0.33|STANDARD_ERROR_OF_MEAN|0.14||0.0161|TWO_SIDED|95.0|-0.6|-0.06||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.||-0.06|-0.60|0.0161
74034009|NCT03280550|147620872|SUPERIORITY||Difference in Least Squares Means|-0.56|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.84|-0.28||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.||-0.28|-0.84|0.0001
74039510|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.168|TWO_SIDED|95.0|-0.18|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.18|0.1680
73874332|NCT03201419|147290628|SUPERIORITY||Mean Difference|-0.287||||0.3205|TWO_SIDED|95.0|-0.856|0.281||Threshold for significance at 0.05 level.|MMRM|||||0.281|-0.856|0.3205
73983809|NCT01044901|147513091|OTHER|||||||0.14||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.14
73983810|NCT01044901|147513092|OTHER|||||||0.13||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.13
73983811|NCT01044901|147513093|OTHER|||||||0.81||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.81
73983812|NCT01044901|147513094|OTHER|||||||0.3||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.30
73983813|NCT04050722|147513139|SUPERIORITY||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.08|-0.04||Analysis was performed using ANCOVA model with study product group, gender, and baseline MGI stratification (low/high) as factors and the baseline value as covariate.|ANCOVA|||||-0.04|-0.08|<0.0001
73983814|NCT00644332|147513149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|0.5||||||||||||Mean change in angina frequency from Baseline to Week 4||||
73983815|NCT00644332|147513150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|STANDARD_ERROR_OF_MEAN|0.5||||||||||||Mean change in NTG use from Baseline to Week 4||||
73983816|NCT00644332|147513151|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|0.8||||||||||||||||
73983817|NCT03602053|147513182|NON_INFERIORITY|If the lower limit of the 95% CI of the ratio of GMCs between the ROTAVAC 5D® and ROTAVAC® groups was larger than 1/2 (i.e. \> 0.5), ROTAVAC 5D® would be considered non-inferior to ROTAVAC®.|GMC ratio|1.294|||||TWO_SIDED|95.0|0.862|1.924|||t-test, 2 sided|||||1.924|0.862|
73983818|NCT00609245|147513205|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANOVA|||||||0.016
73983819|NCT01234675|147513206|SUPERIORITY||Paired difference|4.6||||0.424|TWO_SIDED|95.0|-7.3|16.6|||Paired T test|||||16.6|-7.3|0.424
73983820|NCT01234675|147513207|SUPERIORITY||Paired difference|-6.1||||0.049|TWO_SIDED|95.0|-12.2|-0.04|||Paired T test|||||-0.04|-12.2|0.049
73983821|NCT01234675|147513208|SUPERIORITY||Paired difference|22.6||||0.056|TWO_SIDED|95.0|-0.6|45.8|||Paired T test|||||45.8|-0.6|0.056
73983822|NCT01234675|147513209|SUPERIORITY||Paired difference|-6.1||||0.683|TWO_SIDED|95.0|-12.5|18.5|||Paired T test|||||18.5|-12.5|0.683
73983823|NCT01234675|147513210|SUPERIORITY||Paired difference|-1.502||||0.155|TWO_SIDED|95.0|-59.1|10.4|||Paired T test|||||10.4|-59.1|0.155
73983824|NCT01234675|147513211|SUPERIORITY||Paired difference|-1.0||||0.805|TWO_SIDED|95.0|-9.8|7.8|||Paired T test|||||7.8|-9.8|0.805
73983825|NCT01234675|147513212|SUPERIORITY||Paired difference|-1.0||||0.844|TWO_SIDED|95.0|-11.6|9.6|||Paired T test|||||9.6|-11.6|0.844
73983826|NCT01234675|147513213|SUPERIORITY||Paired difference|2.9||||0.509|TWO_SIDED|95.0|-6.4|12.2|||Paired T test|||||12.2|-6.4|0.509
73983827|NCT01234675|147513214|SUPERIORITY||Paired difference|0.32||||0.3|TWO_SIDED|95.0|-0.3|0.6|||Paired T test|||||0.6|-0.3|0.3
73983828|NCT01234675|147513215|SUPERIORITY||Paired difference|-1.03||||0.685|TWO_SIDED|95.0|-8.2|5.6|||Paired T test|||||5.6|-8.2|0.685
73983829|NCT01234675|147513216|SUPERIORITY||Paired difference|-5.3||||0.349|TWO_SIDED|95.0|-17.0|6.4|||Paired T test|||||6.4|-17.0|0.349
73983830|NCT01234675|147513217|SUPERIORITY||Paired difference|-0.6||||0.305|TWO_SIDED|95.0|-1.8|5.6|||Paired T test|||||5.6|-1.8|0.305
73983831|NCT01234675|147513218|SUPERIORITY||Paired difference|-0.5||||0.425|TWO_SIDED|95.0|-1.8|0.8|||Paired T test|||||0.8|-1.8|0.425
73983832|NCT02889809|147513219|OTHER||Least Square (LS) Mean Difference|-0.16|||||TWO_SIDED|95.0|-0.462|0.142|||||Analysis was performed using an analysis of covariance (ANCOVA) model adjusting for Baseline growth velocity, age at Visit 1, gender and country.|||0.142|-0.462|
73983833|NCT02889809|147513222|OTHER||LS Mean Difference|0.059|||||TWO_SIDED|95.0|-0.455|0.572|||||Analysis was performed using an ANCOVA model adjusting for Baseline growth velocity, age at Visit 1(wk -16), gender and country|||0.572|-0.455|
73983834|NCT00113880|147513226|SUPERIORITY_OR_OTHER|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the relative risk (RR) or hazard ratio (HR) is not estimable.||||0.01
73983835|NCT00113880|147513226|SUPERIORITY_OR_OTHER|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.01
73983836|NCT00113880|147513226|SUPERIORITY_OR_OTHER|||||||0.02||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.02
73983837|NCT00113880|147513226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59||||0.02|TWO_SIDED|95.0|0.64|3.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||3.92|0.64|0.02
73983838|NCT00113880|147513226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.35||||0.01|TWO_SIDED|95.0|2.2|24.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||24.54|2.20|0.01
73983839|NCT00113880|147513226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.17||||0.01|TWO_SIDED|95.0|2.13|24.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||24.13|2.13|0.01
74034010|NCT03280550|147620873|SUPERIORITY||Difference in Least Squares Means|-1.01|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.43|-0.6||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.||-0.60|-1.43|<0.0001
74034011|NCT03280550|147620874|SUPERIORITY||Difference in Least Squares Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.83|-0.31||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.||-0.31|-0.83|<0.0001
74034012|NCT03280550|147620875|SUPERIORITY||Difference in Least Squares Means|-16.12|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-21.86|-10.38||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.||-10.38|-21.86|<0.0001
73983840|NCT00113880|147513227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05||||0.03|TWO_SIDED|95.0|0.0|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||0.79|0.00|0.03
73983841|NCT00113880|147513227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13||||0.05|TWO_SIDED|95.0|0.02|1.0||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||1.00|0.02|0.05
73983842|NCT00113880|147513227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11||||0.04|TWO_SIDED|95.0|0.01|0.86||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||0.86|0.01|0.04
73983843|NCT00113880|147513227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|95.0|0.2|0.7||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.70|0.20|0.01
74034013|NCT03280550|147620876|SUPERIORITY||Difference in Least Squares Means|-0.43|STANDARD_ERROR_OF_MEAN|0.14||0.0023|TWO_SIDED|95.0|-0.7|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.||-0.16|-0.70|0.0023
74034014|NCT03280550|147620877|SUPERIORITY||Odds Ratio (OR)|0.61||||0.6716|TWO_SIDED|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.||5.51|0.05|0.6716
74034015|NCT03280550|147620878|SUPERIORITY||Odds Ratio (OR)|0.0||||0.4815|TWO_SIDED|95.0|0.0|17.64||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.||17.64|0.00|0.4815
73983844|NCT00113880|147513227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.01|TWO_SIDED|95.0|0.22|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the all ages combined group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.74|0.22|0.01
73983845|NCT00113880|147513227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05||||0.01|TWO_SIDED|95.0|0.03|0.08||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age and the all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.08|0.03|0.01
73983846|NCT00113880|147513227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.02||||0.01|TWO_SIDED|95.0|0.01|0.03|||Regression, Cox||Population was the 18-49 year age and all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.03|0.01|0.01
73983847|NCT00113880|147513228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.04|TWO_SIDED|95.0|1.02|4.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Urticaria event rates were presented per 1,000 person-months.||4.13|1.02|0.04
73983848|NCT00113880|147513230|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71||||0.01|TWO_SIDED|95.0|0.56|0.89||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.89|0.56|0.01
73983849|NCT00113880|147513230|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.59||||0.01|TWO_SIDED|95.0|0.41|0.83||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.83|0.41|0.01
73983850|NCT00113880|147513230|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.04|TWO_SIDED|95.0|0.46|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.99|0.46|0.04
73983851|NCT00113880|147513231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.33||||0.01|TWO_SIDED|95.0|0.27|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.41|0.27|0.01
73983852|NCT00113880|147513231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3||||0.01|TWO_SIDED|95.0|0.22|0.42||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.42|0.22|0.01
73983853|NCT00113880|147513231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.34||||0.01|TWO_SIDED|95.0|0.24|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.47|0.24|0.01
74034016|NCT03280550|147620879|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0492|TWO_SIDED|95.0|1.0|13.71|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.||13.71|1.00|0.0492
74034017|NCT03280550|147620880|SUPERIORITY||Odds Ratio (OR)|0.61||||0.6716|TWO_SIDED|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.||5.51|0.05|0.6716
73983854|NCT00113880|147513231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.23|0.75||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.75|0.23|0.01
73983855|NCT00113880|147513231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.01|TWO_SIDED|95.0|0.33|0.44||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.44|0.33|0.01
74034018|NCT03280550|147620881|SUPERIORITY||Odds Ratio (OR)|6.25||||0.0209|TWO_SIDED|95.0|1.32|29.6||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.||29.60|1.32|0.0209
74039511|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.05||0.2968|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.16|0.2968
73874333|NCT03201419|147290628|SUPERIORITY||Mean Difference|-0.418||||0.1769|TWO_SIDED|95.0|-1.026|0.19||Threshold for significance at 0.05 level.|MMRM|||||0.190|-1.026|0.1769
73874334|NCT03201419|147290628|SUPERIORITY||Mean Difference|-0.3||||0.1584|TWO_SIDED|95.0|-0.717|0.118||Threshold for significance at 0.05 level.|MMRM|||||0.118|-0.717|0.1584
73956052|NCT00991276|147447815|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.9|-0.95||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.95|-1.90|<0.0001
73956053|NCT00991276|147447815|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.24||0.0026|TWO_SIDED|95.0|0.26|1.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.21|0.26|0.0026
73956054|NCT00991276|147447816|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|95.0|-8.1|-4.09||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-4.09|-8.10|<0.0001
73956055|NCT00991276|147447816|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|1.01||0.0029|TWO_SIDED|95.0|-5.07|-1.07||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.07|-5.07|0.0029
73956056|NCT00991276|147447816|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.03|STANDARD_ERROR_OF_MEAN|1.01||0.0032|TWO_SIDED|95.0|-5.02|-1.04||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.04|-5.02|0.0032
73956057|NCT00991276|147447818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|10.69|STANDARD_ERROR_OF_MEAN|7.71||0.1677|TWO_SIDED|95.0|-4.56|25.95||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||25.95|-4.56|0.1677
73956058|NCT00991276|147447818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.77|STANDARD_ERROR_OF_MEAN|7.63|<|0.0001|TWO_SIDED|95.0|-50.88|-20.66||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-20.66|-50.88|<0.0001
73983856|NCT00113880|147513231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.01|TWO_SIDED|95.0|0.32|0.5||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.50|0.32|0.01
73983857|NCT00113880|147513231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.36||||0.01|TWO_SIDED|95.0|0.28|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.45|0.28|0.01
73983858|NCT00113880|147513231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41||||0.01|TWO_SIDED|95.0|0.27|0.6||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.60|0.27|0.01
73983859|NCT00113880|147513231|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.05|TWO_SIDED|95.0|0.21|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years, PD2 within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.99|0.21|0.05
74089658|NCT02654587|147732112|SUPERIORITY||P Value|0.0001|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Alopecia in ICI secondary resistance||||<0.0001
73874335|NCT03201419|147290629|SUPERIORITY||Mean Difference|-0.822|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.424||Threshold for significance at 0.05 level.|MMRM|||||-0.424|-1.220|<0.0001
74089659|NCT02654587|147732112|SUPERIORITY||P Value|0.03||||0.03|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC 13 Peripheral neuropathy in ICI secondary resistance||||0.03
73874336|NCT03201419|147290629|SUPERIORITY||Mean Difference|-0.818||||0.0019|TWO_SIDED|95.0|-1.331|-0.306||Threshold for significance at 0.05 level.|MMRM|||||-0.306|-1.331|0.0019
74089660|NCT02654587|147732112|SUPERIORITY||P Value|0.01||||0.01|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Sore mouth in ICI secondary resistance||||0.01
73983860|NCT00113880|147513232|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.01|TWO_SIDED|95.0|0.86|0.98||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.98|0.86|0.01
73983861|NCT00113880|147513232|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.01|TWO_SIDED|95.0|0.75|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs., within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.92|0.75|0.01
73983862|NCT00113880|147513232|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.01|TWO_SIDED|95.0|0.81|0.94||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: All ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.94|0.81|0.01
73983863|NCT00113880|147513232|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.01|TWO_SIDED|95.0|0.7|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.88|0.70|0.01
73983864|NCT00113880|147513232|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.01|TWO_SIDED|95.0|0.29|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.79|0.29|0.01
73983865|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.01|TWO_SIDED|95.0|0.45|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.51|0.45|0.01
73983866|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.51||||0.01|TWO_SIDED|95.0|0.47|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.56|0.47|0.01
73983867|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.38|0.46||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.46|0.38|0.01
74089661|NCT02654587|147732112|SUPERIORITY||P Value|0.01||||0.01|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Dysphagia in ICI secondary resistance||||0.01
74089662|NCT02654587|147732112|SUPERIORITY||P Value|0.35||||0.35|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Pain in arm and shoulder||||0.35
74089663|NCT02654587|147732112|SUPERIORITY||P Value|0.43||||0.43|TWO_SIDED||||||Mantel Haenszel|||QLQ-LC13 Pain in chest in ICI secondary resistance||||0.43
73874337|NCT03201419|147290629|SUPERIORITY||Mean Difference|0.167||||0.551|TWO_SIDED|95.0|-0.383|0.716||Threshold for significance at 0.05 level.|MMRM|||||0.716|-0.383|0.5510
73874338|NCT03201419|147290629|SUPERIORITY||Mean Difference|-0.038||||0.9086|TWO_SIDED|95.0|-0.685|0.61||Threshold for significance at 0.05 level.|MMRM|||||0.610|-0.685|0.9086
73983868|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57||||0.01|TWO_SIDED|95.0|0.49|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.67|0.49|0.01
74089664|NCT02654587|147732112|SUPERIORITY||P Value|0.78||||0.78|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Pain in other parts||||0.78
74089665|NCT02654587|147732112|SUPERIORITY||P Value|0.23||||0.23|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC 13 Hemoptysis in ICI secondary resistance||||0.23
74089666|NCT02654587|147732112|SUPERIORITY||P Value|0.54||||0.54|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Coughing in ICI secondary resistance||||0.54
74089667|NCT02654587|147732113|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.43|2.75|||Mantel Haenszel|||DCR at 6 months in patients with ICI secondary resistance||2.75|0.43|0.87
74089668|NCT02654587|147732113|SUPERIORITY||Odds Ratio (OR)|0.73||||0.37|TWO_SIDED|95.0|0.36|1.46|||Mantel Haenszel|||DCR at 6 months in ITT patients with ICI resistance (primary and secondary)||1.46|0.36|0.37
74089669|NCT02654587|147732114|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.29|TWO_SIDED|95.0|0.82|2.0|||t-test, 2 sided|||Median PFS in patients with ICI secondary resistance||2.0|0.82|0.29
74089670|NCT02654587|147732114|SUPERIORITY||Hazard Ratio (HR)|1.64|||<|0.05|TWO_SIDED|95.0|1.18|2.28|||t-test, 2 sided|||Median PFS in ITT patients with ICI resistance (primary and secondary)||2.28|1.18|<0.05
73983869|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.51||||0.01|TWO_SIDED|95.0|0.33|0.76||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.76|0.33|0.01
73983870|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.39|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates event rates were presented per 1,000 person-months.||0.45|0.39|0.01
73983871|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.38|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.47|0.38|0.01
73983872|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.01|TWO_SIDED|95.0|0.34|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.41|0.34|0.01
73983873|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.58||||0.05|TWO_SIDED|95.0|0.49|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.68|0.49|0.05
73983874|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28||||0.01|TWO_SIDED|95.0|0.15|0.52||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/Rad event rates were presented per 1,000 person-months.||0.52|0.15|0.01
73983875|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.01|TWO_SIDED|95.0|0.66|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.85|0.66|0.01
74034019|NCT03280550|147620882|SUPERIORITY||Difference in Least Squares Means|-1.91|STANDARD_ERROR_OF_MEAN|0.48||0.0001|TWO_SIDED|95.0|-2.85|-0.96||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.||-0.96|-2.85|0.0001
74034020|NCT03280550|147620883|SUPERIORITY||Difference in Least Squares Means|3.81|STANDARD_ERROR_OF_MEAN|1.23||0.0024|TWO_SIDED|95.0|1.38|6.24||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.||6.24|1.38|0.0024
74034021|NCT03552549|147620914|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.28|1.77|||||Hazard ratio presented as PEG-Intron/INTRON A; HR \<1 indicates treatment effect in favor of PEG-Intron.|||1.77|0.28|
74034022|NCT02094586|147620923|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.78|1.08||||||Lot A vs. Lot B||1.08|0.78|
73874339|NCT03201419|147290629|SUPERIORITY||Mean Difference|-0.812||||0.0185|TWO_SIDED|95.0|-1.486|-0.138||Threshold for significance at 0.05 level.|MMRM|||||-0.138|-1.486|0.0185
74034023|NCT02094586|147620928|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|1.02|||||TWO_SIDED|95.0|0.87|1.2||||||Lot B vs Lot C||1.20|0.87|
74034024|NCT02094586|147620929|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.1||||||Lot A vs. Lot C||1.10|0.80|
74034025|NCT02761993|147620930|SUPERIORITY|||||||0.341||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equation|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.341
74034026|NCT02761993|147620930|SUPERIORITY|||||||0.774||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.774
74034027|NCT02761993|147620931|SUPERIORITY|||||||0.501||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.501
73874340|NCT03201419|147290629|SUPERIORITY||Mean Difference|-0.106||||0.6537|TWO_SIDED|95.0|-0.569|0.357||Threshold for significance at 0.05 level.|MMRM|||||0.357|-0.569|0.6537
73874341|NCT03201419|147290630|SUPERIORITY||Least Square Mean Difference|-0.146||||0.235|TWO_SIDED|95.0|-0.388|0.096||Threshold for significance at 0.05 level.|MMRM|||||0.096|-0.388|0.2350
73983876|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.02|TWO_SIDED|95.0|0.7|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.97|0.70|0.02
73983877|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.72||||0.01|TWO_SIDED|95.0|0.58|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.88|0.58|0.01
73983878|NCT00113880|147513233|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.01|TWO_SIDED|95.0|0.27|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.78|0.27|0.01
73983879|NCT00113880|147513234|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.04|TWO_SIDED|95.0|0.0|0.82||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Encephalitis/encephalopathy event rates were presented per 1,000 person-months.||0.82|0.00|0.04
73983880|NCT00113880|147513235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.01|TWO_SIDED|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.91|0.47|0.01
73983881|NCT00113880|147513235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.01|TWO_SIDED|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.57|0.21|0.01
73983882|NCT00113880|147513235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.77|0.47|0.01
74034028|NCT02761993|147620931|SUPERIORITY|||||||0.486||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.486
74034029|NCT02761993|147620932|SUPERIORITY|||||||0.816|||||||ANCOVA|||||||0.816
74034030|NCT02761993|147620932|SUPERIORITY|||||||0.706|||||||ANCOVA|||||||0.706
73874342|NCT03201419|147290630|SUPERIORITY||Least Square Mean Difference|-0.377||||0.0215|TWO_SIDED|95.0|-0.699|-0.056||Threshold for significance at 0.05 level.|MMRM|||||-0.056|-0.699|0.0215
73874343|NCT03201419|147290630|SUPERIORITY||Least Square Mean Difference|-0.218||||0.1818|TWO_SIDED|95.0|-0.54|0.103||Threshold for significance at 0.05 level.|MMRM|||||0.103|-0.540|0.1818
73874344|NCT03201419|147290630|SUPERIORITY||Least Square Mean Difference|-0.05||||0.8063|TWO_SIDED|95.0|-0.45|0.35||Threshold for significance at 0.05 level.|MMRM|||||0.350|-0.450|0.8063
74034031|NCT00875017|147620943|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-65.75|||<|0.001||95.0|-96.01|-35.49|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-35.49|-96.01|<0.001
74034032|NCT00875017|147620943|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-125.65|||<|0.001||95.0|-155.91|-95.39|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-95.39|-155.91|<0.001
74034033|NCT00875017|147620943|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-59.9|||<|0.001||95.0|-89.87|-29.93|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-29.93|-89.87|<0.001
74034034|NCT00875017|147620944|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|71.9|||<|0.001||95.0|40.03|103.77|||Mixed Models Analysis|||Phosphorus binding was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||103.77|40.03|<0.001
74034035|NCT00875017|147620945|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.67||||0.049||95.0|-41.22|-0.13|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-0.13|-41.22|0.049
74034036|NCT00875017|147620945|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-15.56||||0.133||95.0|-36.11|4.99|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||4.99|-36.11|0.133
73983883|NCT00113880|147513235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.48|0.23|0.01
73874345|NCT03201419|147290630|SUPERIORITY||Least Square Mean Difference|0.176||||0.4414|TWO_SIDED|95.0|-0.274|0.627||Threshold for significance at 0.05 level.|MMRM|||||0.627|-0.274|0.4414
73874346|NCT03201419|147290630|SUPERIORITY||Least Square Mean Difference|-0.126||||0.4179|TWO_SIDED|95.0|-0.432|0.18||Threshold for significance at 0.05 level.|MMRM|||||0.180|-0.432|0.4179
73874347|NCT03201419|147290631|SUPERIORITY||Least Square Mean Difference|0.061||||0.6042|TWO_SIDED|95.0|-0.17|0.292||Threshold for significance at 0.05 level.|MMRM|||||0.292|-0.170|0.6042
73874348|NCT03201419|147290631|SUPERIORITY||Least Square Mean Difference|-0.127||||0.4114|TWO_SIDED|95.0|-0.432|0.177||Threshold for significance at 0.05 level.|MMRM|||||0.177|-0.432|0.4114
73874349|NCT03201419|147290631|SUPERIORITY||Least Square Mean Difference|0.099||||0.5394|TWO_SIDED|95.0|-0.219|0.418||Threshold for significance at 0.05 level.|MMRM|||||0.418|-0.219|0.5394
73874350|NCT03201419|147290631|SUPERIORITY||Least Square Mean Difference|0.149||||0.459|TWO_SIDED|95.0|-0.246|0.544||Threshold for significance at 0.05 level.|MMRM|||||0.544|-0.246|0.4590
73874351|NCT03201419|147290631|SUPERIORITY||Least Square Mean Difference|0.242||||0.2397|TWO_SIDED|95.0|-0.163|0.647||Threshold for significance at 0.05 level.|MMRM|||||0.647|-0.163|0.2397
73874352|NCT03201419|147290631|SUPERIORITY||Least Square Mean Difference|-0.039||||0.7954|TWO_SIDED|95.0|-0.332|0.254||Threshold for significance at 0.05 level.|MMRM|||||0.254|-0.332|0.7954
73874353|NCT03201419|147290632|SUPERIORITY||Least Square Mean Difference|-0.332||||0.0077|TWO_SIDED|95.0|-0.576|-0.089||Threshold for significance at 0.05 level.|MMRM|||||-0.089|-0.576|0.0077
73874354|NCT03201419|147290632|SUPERIORITY||Least Square Mean Difference|-0.61||||0.0002|TWO_SIDED|95.0|-0.927|-0.293||Threshold for significance at 0.05 level.|MMRM|||||-0.293|-0.927|0.0002
73983884|NCT00113880|147513236|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.01|TWO_SIDED|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.91|0.47|0.01
73983885|NCT00113880|147513236|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.01|TWO_SIDED|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.57|0.21|0.01
73983886|NCT00113880|147513236|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.77|0.47|0.01
73983887|NCT00113880|147513236|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.48|0.23|0.01
74089671|NCT02654587|147732115|SUPERIORITY|ORR in ICI secondary resistance|Odds Ratio (OR)|0.33||||0.07|TWO_SIDED|95.0|0.1|1.11|||Mantel Haenszel|||||1.11|0.10|0.07
73874355|NCT03201419|147290632|SUPERIORITY||Least Square Mean Difference|-0.026||||0.8778|TWO_SIDED|95.0|-0.352|0.301||Threshold for significance at 0.05 level.|MMRM|||||0.301|-0.352|0.8778
73874356|NCT03201419|147290632|SUPERIORITY||Least Square Mean Difference|0.157||||0.4309|TWO_SIDED|95.0|-0.235|0.549||Threshold for significance at 0.05 level.|MMRM|||||0.549|-0.235|0.4309
73874357|NCT03201419|147290632|SUPERIORITY||Least Square Mean Difference|-0.017||||0.9392|TWO_SIDED|95.0|-0.444|0.411||Threshold for significance at 0.05 level.|MMRM|||||0.411|-0.444|0.9392
73874358|NCT03201419|147290632|SUPERIORITY||Least Square Mean Difference|-0.213||||0.1734|TWO_SIDED|95.0|-0.521|0.094||Threshold for significance at 0.05 level.|MMRM|||||0.094|-0.521|0.1734
73874359|NCT03201419|147290633|SUPERIORITY||Least Square Mean Difference|-0.328||||0.0133|TWO_SIDED|95.0|-0.587|-0.069||Threshold for significance at 0.05 level.|MMRM|||||-0.069|-0.587|0.0133
73874360|NCT03201419|147290633|SUPERIORITY||Least Square Mean Difference|-0.484||||0.0048|TWO_SIDED|95.0|-0.819|-0.15||Threshold for significance at 0.05 level.|MMRM|||||-0.150|-0.819|0.0048
73874361|NCT03201419|147290633|SUPERIORITY||Least Square Mean Difference|-0.04||||0.8223|TWO_SIDED|95.0|-0.395|0.314||Threshold for significance at 0.05 level.|MMRM|||||0.314|-0.395|0.8223
73874362|NCT03201419|147290633|SUPERIORITY||Least Square Mean Difference|0.215||||0.3083|TWO_SIDED|95.0|-0.2|0.63||Threshold for significance at 0.05 level.|MMRM|||||0.630|-0.200|0.3083
73874363|NCT03201419|147290633|SUPERIORITY||Least Square Mean Difference|-0.315||||0.1556|TWO_SIDED|95.0|-0.75|0.121||Threshold for significance at 0.05 level.|MMRM|||||0.121|-0.750|0.1556
73874364|NCT03201419|147290633|SUPERIORITY||Least Square Mean Difference|-0.188||||0.2423|TWO_SIDED|95.0|-0.504|0.128||Threshold for significance at 0.05 level.|MMRM|||||0.128|-0.504|0.2423
73874365|NCT03201419|147290634|SUPERIORITY||Least Square Mean Difference|-0.079||||0.6381|TWO_SIDED|95.0|-0.409|0.251||Threshold for significance at 0.05 level.|MMRM|||||0.251|-0.409|0.6381
73874366|NCT03201419|147290634|SUPERIORITY||Least Square Mean Difference|-0.502||||0.0221|TWO_SIDED|95.0|-0.931|-0.073||Threshold for significance at 0.05 level.|MMRM|||||-0.073|-0.931|0.0221
73874367|NCT03201419|147290634|SUPERIORITY||Least Square Mean Difference|-0.177||||0.4112|TWO_SIDED|95.0|-0.602|0.247||Threshold for significance at 0.05 level.|MMRM|||||0.247|-0.602|0.4112
73983888|NCT00113880|147513237|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.01|TWO_SIDED|95.0|0.57|0.73||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.73|0.57|0.01
73983889|NCT00113880|147513237|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.01|TWO_SIDED|95.0|0.36|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.51|0.36|0.01
73983890|NCT00113880|147513238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.01|TWO_SIDED|95.0|0.26|0.33||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.33|0.26|0.01
73983891|NCT00113880|147513238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.01|TWO_SIDED|95.0|0.13|0.18||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.18|0.13|0.01
73983892|NCT00113880|147513239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.04|TWO_SIDED|95.0|0.03|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.||0.93|0.03|0.04
73983893|NCT00113880|147513239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.02|TWO_SIDED|95.0|0.4|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.92|0.40|0.02
73983894|NCT00113880|147513239|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.01|TWO_SIDED|95.0|0.28|0.84||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.84|0.28|0.01
73983895|NCT00113880|147513239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.02|TWO_SIDED|95.0|0.1|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.78|0.10|0.02
73983896|NCT00113880|147513239|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.02|TWO_SIDED|95.0|0.63|0.96||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.96|0.63|0.02
73983897|NCT00113880|147513239|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69||||0.03|TWO_SIDED|95.0|0.5|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.97|0.50|0.03
73983898|NCT00113880|147513239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.01||95.0|0.21|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.79|0.21|0.01
74034037|NCT00875017|147620945|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.11||||0.612||95.0|-15.24|25.47|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||25.47|-15.24|0.612
74039512|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0219|TWO_SIDED|95.0|-0.23|-0.02|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.23|0.0219
74089672|NCT02654587|147732115|SUPERIORITY|ORR in ITT population with ICI resistance (primary and secondary)|Odds Ratio (OR)|0.22||||0.002|TWO_SIDED|95.0|0.08|0.59|||Mantel Haenszel|||||0.59|0.08|0.002
73874368|NCT03201419|147290634|SUPERIORITY||Least Square Mean Difference|0.112||||0.6761|TWO_SIDED|95.0|-0.416|0.64||Threshold for significance at 0.05 level.|MMRM|||||0.640|-0.416|0.6761
73874369|NCT03201419|147290634|SUPERIORITY||Least Square Mean Difference|0.224||||0.4898|TWO_SIDED|95.0|-0.414|0.861||Threshold for significance at 0.05 level.|MMRM|||||0.861|-0.414|0.4898
73874370|NCT03201419|147290634|SUPERIORITY||Least Square Mean Difference|0.194||||0.3311|TWO_SIDED|95.0|-0.198|0.585||Threshold for significance at 0.05 level.|MMRM|||||0.585|-0.198|0.3311
73874371|NCT03201419|147290635|SUPERIORITY||Least Square Mean Difference|-0.23||||0.1583|TWO_SIDED|95.0|-0.551|0.09||Threshold for significance at 0.05 level.|MMRM|||||0.090|-0.551|0.1583
73983899|NCT00113880|147513240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.95||||0.02|TWO_SIDED|95.0|1.14|3.34||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.||3.34|1.14|0.02
73983900|NCT00113880|147513240|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Irritable bowel syndrome event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.02
73983901|NCT00113880|147513241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|0.15|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.57|0.15|0.01
73983902|NCT00113880|147513241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.03|TWO_SIDED|95.0|0.12|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.92|0.12|0.03
73983903|NCT00113880|147513241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.01|TWO_SIDED|95.0|0.13|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.74|0.13|0.01
73983904|NCT00113880|147513241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.04|TWO_SIDED|95.0|0.55|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.||0.99|0.55|0.04
73983905|NCT00113880|147513241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.04|TWO_SIDED|95.0|0.14|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.||0.93|0.14|0.04
73983906|NCT00113880|147513241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.02|TWO_SIDED|95.0|0.71|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.||0.97|0.71|0.02
73983907|NCT00113880|147513241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.01|TWO_SIDED|95.0|0.57|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.||0.92|0.57|0.01
74039513|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0717|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.25|0.0717
74089673|NCT02654587|147732116|SUPERIORITY|Duration of response at 6 months in ICI secondary resistance|Hazard Ratio (HR)|1.14||||0.88|TWO_SIDED|95.0|0.25|5.3|||Regression, Cox|||||5.30|0.25|0.88
73874372|NCT03201419|147290635|SUPERIORITY||Least Square Mean Difference|-0.275||||0.1884|TWO_SIDED|95.0|-0.685|0.136||Threshold for significance at 0.05 level.|MMRM|||||0.136|-0.685|0.1884
73956059|NCT00991276|147447818|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|46.47|STANDARD_ERROR_OF_MEAN|7.59|<|0.0001|TWO_SIDED|95.0|31.45|61.48||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||61.48|31.45|<0.0001
73874373|NCT03201419|147290635|SUPERIORITY||Least Square Mean Difference|-0.047||||0.8256|TWO_SIDED|95.0|-0.463|0.369||Threshold for significance at 0.05 level.|MMRM|||||0.369|-0.463|0.8256
73874374|NCT03201419|147290635|SUPERIORITY||Least Square Mean Difference|0.059||||0.8198|TWO_SIDED|95.0|-0.455|0.574||Threshold for significance at 0.05 level.|MMRM|||||0.574|-0.455|0.8198
73874375|NCT03201419|147290635|SUPERIORITY||Least Square Mean Difference|-0.431||||0.1793|TWO_SIDED|95.0|-1.061|0.199||Threshold for significance at 0.05 level.|MMRM|||||0.199|-1.061|0.1793
73874376|NCT03201419|147290635|SUPERIORITY||Least Square Mean Difference|-0.196||||0.3155|TWO_SIDED|95.0|-0.581|0.189||Threshold for significance at 0.05 level.|MMRM|||||0.189|-0.581|0.3155
73874377|NCT03201419|147290636|SUPERIORITY||Least Square Mean Difference|-0.241||||0.183|TWO_SIDED|95.0|-0.596|0.114||Threshold for significance at 0.05 level.|MMRM|||||0.114|-0.596|0.1830
73874378|NCT03201419|147290636|SUPERIORITY||Least Square Mean Difference|-0.313||||0.1618|TWO_SIDED|95.0|-0.751|0.126||Threshold for significance at 0.05 level.|MMRM|||||0.126|-0.751|0.1618
73874379|NCT03201419|147290636|SUPERIORITY||Least Square Mean Difference|-0.26||||0.2519|TWO_SIDED|95.0|-0.706|0.186||Threshold for significance at 0.05 level.|MMRM|||||0.186|-0.706|0.2519
73983908|NCT00113880|147513241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.01|TWO_SIDED|95.0|0.22|0.61||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.61|0.22|0.01
73983909|NCT00113880|147513241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.16|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.68|0.16|0.01
73874380|NCT03201419|147290636|SUPERIORITY||Least Square Mean Difference|0.232||||0.4044|TWO_SIDED|95.0|-0.316|0.781||Threshold for significance at 0.05 level.|MMRM|||||0.781|-0.316|0.4044
73983910|NCT00113880|147513241|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.03|TWO_SIDED|95.0|0.0|0.82|||Fisher Exact||Population: 18-49, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.82|0.00|0.03
73983911|NCT00113880|147513242|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.01|TWO_SIDED|95.0|0.58|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.58|0.01
73983912|NCT00113880|147513242|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.01|TWO_SIDED|95.0|0.49|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.49|0.01
73983913|NCT00113880|147513242|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.01|TWO_SIDED|95.0|0.61|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.92|0.61|0.01
73983914|NCT00113880|147513242|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.01|TWO_SIDED|95.0|0.52|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.91|0.52|0.01
73983915|NCT00113880|147513243|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.01|TWO_SIDED|95.0|0.33|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.51|0.33|0.01
74034038|NCT03342469|147620946|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
73874381|NCT03201419|147290636|SUPERIORITY||Least Square Mean Difference|-0.28||||0.4348|TWO_SIDED|95.0|-0.986|0.426||Threshold for significance at 0.05 level.|MMRM|||||0.426|-0.986|0.4348
73874382|NCT03201419|147290636|SUPERIORITY||Least Square Mean Difference|-0.15||||0.4786|TWO_SIDED|95.0|-0.565|0.266||Threshold for significance at 0.05 level.|MMRM|||||0.266|-0.565|0.4786
73874383|NCT03201419|147290637|SUPERIORITY||Least Square Mean Difference|-0.223||||0.2412|TWO_SIDED|95.0|-0.598|0.151||Threshold for significance at 0.05 level.|MMRM|||||0.151|-0.598|0.2412
73874384|NCT03201419|147290637|SUPERIORITY||Least Square Mean Difference|-0.48||||0.0501|TWO_SIDED|95.0|-0.959|0.0||Threshold for significance at 0.05 level.|MMRM|||||0.000|-0.959|0.0501
73874385|NCT03201419|147290637|SUPERIORITY||Least Square Mean Difference|0.069||||0.7788|TWO_SIDED|95.0|-0.417|0.556||Threshold for significance at 0.05 level.|MMRM|||||0.556|-0.417|0.7788
73874386|NCT03201419|147290637|SUPERIORITY||Least Square Mean Difference|-0.111||||0.7111|TWO_SIDED|95.0|-0.698|0.477||Threshold for significance at 0.05 level.|MMRM|||||0.477|-0.698|0.7111
73874387|NCT03201419|147290637|SUPERIORITY||Least Square Mean Difference|-0.205||||0.5816|TWO_SIDED|95.0|-0.937|0.527||Threshold for significance at 0.05 level.|MMRM|||||0.527|-0.937|0.5816
73874388|NCT03201419|147290637|SUPERIORITY||Least Square Mean Difference|-0.152||||0.4981|TWO_SIDED|95.0|-0.595|0.29||Threshold for significance at 0.05 level.|MMRM|||||0.290|-0.595|0.4981
73874389|NCT03201419|147290638|SUPERIORITY||Least Square Mean Difference|-1.313||||0.1733|TWO_SIDED|95.0|-3.207|0.582||Threshold for significance at 0.05 level.|MMRM|||||0.582|-3.207|0.1733
73983916|NCT00113880|147513243|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|95.0|0.26|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.55|0.26|0.01
73983917|NCT00113880|147513243|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.01|TWO_SIDED|95.0|0.31|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.56|0.31|0.01
73983918|NCT00113880|147513243|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.02|TWO_SIDED|95.0|0.26|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.26|0.02
73983919|NCT00113880|147513243|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.01||95.0|0.37|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.55|0.37|0.01
73983920|NCT00113880|147513243|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.01|TWO_SIDED|95.0|0.35|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.67|0.35|0.01
73983921|NCT00113880|147513243|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.01|TWO_SIDED|95.0|0.33|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.56|0.33|0.01
73983922|NCT00113880|147513243|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46||||0.01|TWO_SIDED|95.0|0.25|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.85|0.25|0.01
73983923|NCT00113880|147513244|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47||||0.01|TWO_SIDED|95.0|0.32|0.69||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.69|0.32|0.01
73983924|NCT00113880|147513244|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.01|TWO_SIDED|95.0|0.17|0.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.54|0.17|0.01
73983925|NCT02186015|147513269|SUPERIORITY|A Wilcoxon signed rank test was performed.|||||<|0.01|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in serum 25(OH)D from week 0 to week 8.||||<0.01
73983926|NCT02186015|147513270|SUPERIORITY|A Wilcoxon signed rank test was performed.||||||0.24|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in worst pain rating from week 0 to week 8.||||0.24
73874390|NCT03201419|147290638|SUPERIORITY||Least Square Mean Difference|-1.375||||0.2538|TWO_SIDED|95.0|-3.745|0.994||Threshold for significance at 0.05 level.|MMRM|||||0.994|-3.745|0.2538
73983927|NCT02186015|147513271|SUPERIORITY|||||||0.09|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in fatigue score from week 0 to week 8.||||0.09
73983928|NCT02186015|147513272|SUPERIORITY|||||||0.17|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in mood score from week 0 to week 8.||||0.17
73983929|NCT02186015|147513273|SUPERIORITY|||||||0.5|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in dominant handgrip strength from week 0 to week 8.||||0.50
73983930|NCT02186015|147513274|SUPERIORITY|||||||0.16|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in sleep quality assessment from week 0 to week 8.||||0.16
73983931|NCT02186015|147513275|SUPERIORITY|||||||0.75|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in functional assessment of cancer therapy-breast score from week 0 to week 8.||||0.75
73983932|NCT02186015|147513276|SUPERIORITY|||||||0.19|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in functional assessment of cancer therapy-endocrine score from week 0 to week 8.||||0.19
74034039|NCT03342469|147620946|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
73874391|NCT03201419|147290638|SUPERIORITY||Least Square Mean Difference|-0.353||||0.7782|TWO_SIDED|95.0|-2.818|2.113||Threshold for significance at 0.05 level.|MMRM|||||2.113|-2.818|0.7782
73874392|NCT03201419|147290638|SUPERIORITY||Least Square Mean Difference|-0.151||||0.9218|TWO_SIDED|95.0|-3.182|2.88||Threshold for significance at 0.05 level.|MMRM|||||2.880|-3.182|0.9218
74089674|NCT02654587|147732116|SUPERIORITY|Duration of Response at 6 months in ITT population with ICI resistance (primary and secondary)|Hazard Ratio (HR)|1.41||||0.57|TWO_SIDED|95.0|0.43|4.6|||Regression, Cox|||||4.60|0.43|0.57
73874393|NCT03201419|147290638|SUPERIORITY||Least Square Mean Difference|0.767||||0.6823|TWO_SIDED|95.0|-2.923|4.457||Threshold for significance at 0.05 level.|MMRM|||||4.457|-2.923|0.6823
73956060|NCT00991276|147447819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.73|STANDARD_ERROR_OF_MEAN|4.72||0.104|TWO_SIDED|95.0|-17.07|1.61||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.61|-17.07|0.1040
73956061|NCT00991276|147447819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|4.68||0.9325|TWO_SIDED|95.0|-9.67|8.87||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.87|-9.67|0.9325
73956062|NCT00991276|147447819|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|4.65||0.1175|TWO_SIDED|95.0|-16.54|1.87||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.87|-16.54|0.1175
73956063|NCT00991276|147447820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-23.98|STANDARD_ERROR_OF_MEAN|4.45|<|0.0001|TWO_SIDED|95.0|-32.78|-15.18||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-15.18|-32.78|<0.0001
73956064|NCT00991276|147447820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.74|STANDARD_ERROR_OF_MEAN|4.41|<|0.0001|TWO_SIDED|95.0|-33.46|-16.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-16.02|-33.46|<0.0001
73956065|NCT00991276|147447820|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|4.38||0.8622|TWO_SIDED|95.0|-7.9|9.43||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||9.43|-7.90|0.8622
73956066|NCT00991276|147447821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.87||0.08|TWO_SIDED|95.0|-7.0|0.4||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.40|-7.00|0.0800
73956067|NCT00991276|147447821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|1.86||0.2209|TWO_SIDED|95.0|-5.95|1.39||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.39|-5.95|0.2209
74089675|NCT02654587|147732117|SUPERIORITY|Time to next lung cancer therapy in ICI secondary resistance|Hazard Ratio (HR)|1.85||||0.04|TWO_SIDED|95.0|1.03|3.31|||Regression, Cox|||||3.31|1.03|0.04
74089676|NCT02654587|147732117|SUPERIORITY|Time to next lung cancer therapy in ITT population with ICI resistance (primary and secondary)|Hazard Ratio (HR)|1.59||||0.02|TWO_SIDED|95.0|1.07|2.36|||Regression, Cox|||||2.36|1.07|0.02
74089677|NCT02654587|147732118|SUPERIORITY||Hazard Ratio (HR)|1.36|||<|0.05|TWO_SIDED|95.0|1.0|1.86|||t-test, 2 sided|||||1.86|1.00|<0.05
73874394|NCT03201419|147290638|SUPERIORITY||Least Square Mean Difference|-1.095||||0.3436|TWO_SIDED|95.0|-3.369|1.179||Threshold for significance at 0.05 level.|MMRM|||||1.179|-3.369|0.3436
73874395|NCT03201419|147290639|SUPERIORITY||Least Square Mean Difference|-1.235||||0.2042|TWO_SIDED|95.0|-3.146|0.676||Threshold for significance at 0.05 level.|MMRM|||||0.676|-3.146|0.2042
73874396|NCT03201419|147290639|SUPERIORITY||Least Square Mean Difference|-1.683||||0.1591|TWO_SIDED|95.0|-4.031|0.665||Threshold for significance at 0.05 level.|MMRM|||||0.665|-4.031|0.1591
73874397|NCT03201419|147290639|SUPERIORITY||Least Square Mean Difference|-0.285||||0.8168|TWO_SIDED|95.0|-2.708|2.138||Threshold for significance at 0.05 level.|MMRM|||||2.138|-2.708|0.8168
73874398|NCT03201419|147290639|SUPERIORITY||Least Square Mean Difference|-0.551||||0.7148|TWO_SIDED|95.0|-3.517|2.416||Threshold for significance at 0.05 level.|MMRM|||||2.416|-3.517|0.7148
73874399|NCT03201419|147290639|SUPERIORITY||Least Square Mean Difference|0.701||||0.7141|TWO_SIDED|95.0|-3.066|4.468||Threshold for significance at 0.05 level.|MMRM|||||4.468|-3.066|0.7141
73874400|NCT03201419|147290639|SUPERIORITY||Least Square Mean Difference|-0.759||||0.5041|TWO_SIDED|95.0|-2.995|1.477||Threshold for significance at 0.05 level.|MMRM|||||1.477|-2.995|0.5041
73874401|NCT03201419|147290640|SUPERIORITY||Least Square Mean Difference|-1.129||||0.2896|TWO_SIDED|95.0|-3.226|0.967||Threshold for significance at 0.05 level.|MMRM|||||0.967|-3.226|0.2896
73874402|NCT03201419|147290640|SUPERIORITY||Least Square Mean Difference|-2.652||||0.0498|TWO_SIDED|95.0|-5.301|-0.003||Threshold for significance at 0.05 level.|MMRM|||||-0.003|-5.301|0.0498
73874403|NCT03201419|147290640|SUPERIORITY||Least Square Mean Difference|0.323||||0.8159|TWO_SIDED|95.0|-2.409|3.055||Threshold for significance at 0.05 level.|MMRM|||||3.055|-2.409|0.8159
73874404|NCT03201419|147290640|SUPERIORITY||Least Square Mean Difference|0.485||||0.7719|TWO_SIDED|95.0|-2.809|3.779||Threshold for significance at 0.05 level.|MMRM|||||3.779|-2.809|0.7719
73874405|NCT03201419|147290640|SUPERIORITY||Least Square Mean Difference|1.676||||0.4193|TWO_SIDED|95.0|-2.407|5.76||Threshold for significance at 0.05 level.|MMRM|||||5.760|-2.407|0.4193
73874406|NCT03201419|147290640|SUPERIORITY||Least Square Mean Difference|-1.23||||0.3333|TWO_SIDED|95.0|-3.73|1.27||Threshold for significance at 0.05 level.|MMRM|||||1.270|-3.730|0.3333
73874407|NCT03201419|147290641|SUPERIORITY||Mean Difference|41.8||||0.0853|TWO_SIDED|95.0|-5.9|89.6||Threshold for significance at 0.05 level.|MMRM|||||89.6|-5.9|0.0853
73874408|NCT03201419|147290641|SUPERIORITY||Mean Difference|105.9||||0.001|TWO_SIDED|95.0|43.4|168.4||Threshold for significance at 0.05 level.|MMRM|||||168.4|43.4|0.0010
73874409|NCT03201419|147290641|SUPERIORITY||Mean Difference|24.9||||0.4418|TWO_SIDED|95.0|-38.8|88.6||Threshold for significance at 0.05 level.|MMRM|||||88.6|-38.8|0.4418
73874410|NCT03201419|147290641|SUPERIORITY||Mean Difference|10.7||||0.7902|TWO_SIDED|95.0|-68.2|89.6||Threshold for significance at 0.05 level.|MMRM|||||89.6|-68.2|0.7902
73874411|NCT03201419|147290641|SUPERIORITY||Mean Difference|1.8||||0.9664|TWO_SIDED|95.0|-84.2|87.9||Threshold for significance at 0.05 level.|MMRM|||||87.9|-84.2|0.9664
73874412|NCT03201419|147290641|SUPERIORITY||Mean Difference|-29.8||||0.2977|TWO_SIDED|95.0|-85.9|26.4||Threshold for significance at 0.05 level.|MMRM|||||26.4|-85.9|0.2977
73874413|NCT03201419|147290642|SUPERIORITY||Mean Difference|14.3||||0.5523|TWO_SIDED|95.0|-33.0|61.5||Threshold for significance at 0.05 level.|MMRM|||||61.5|-33.0|0.5523
73874414|NCT03201419|147290642|SUPERIORITY||Mean Difference|60.8||||0.0556|TWO_SIDED|95.0|-1.5|123.0||Threshold for significance at 0.05 level.|MMRM|||||123.0|-1.5|0.0556
73874415|NCT03201419|147290642|SUPERIORITY||Mean Difference|-17.9||||0.5837|TWO_SIDED|95.0|-82.0|46.3||Threshold for significance at 0.05 level.|MMRM|||||46.3|-82.0|0.5837
73874416|NCT03201419|147290642|SUPERIORITY||Mean Difference|-60.7||||0.1363|TWO_SIDED|95.0|-140.7|19.3||Threshold for significance at 0.05 level.|MMRM|||||19.3|-140.7|0.1363
73874417|NCT03201419|147290642|SUPERIORITY||Mean Difference|-28.2||||0.4938|TWO_SIDED|95.0|-109.1|52.8||Threshold for significance at 0.05 level.|MMRM|||||52.8|-109.1|0.4938
73874418|NCT03201419|147290642|SUPERIORITY||Mean Difference|-54.7||||0.0535|TWO_SIDED|95.0|-110.2|0.8||Threshold for significance at 0.05 level.|MMRM|||||0.8|-110.2|0.0535
73874419|NCT03201419|147290643|SUPERIORITY||Mean Difference|-0.7||||0.9829|TWO_SIDED|95.0|-62.2|60.9||Threshold for significance at 0.05 level.|MMRM|||||60.9|-62.2|0.9829
73874420|NCT03201419|147290643|SUPERIORITY||Mean Difference|64.4||||0.1038|TWO_SIDED|95.0|-13.3|142.1||Threshold for significance at 0.05 level.|MMRM|||||142.1|-13.3|0.1038
73874421|NCT03201419|147290643|SUPERIORITY||Mean Difference|29.2||||0.4764|TWO_SIDED|95.0|-51.4|109.8||Threshold for significance at 0.05 level.|MMRM|||||109.8|-51.4|0.4764
73874422|NCT03201419|147290643|SUPERIORITY||Mean Difference|-24.2||||0.6204|TWO_SIDED|95.0|-120.5|72.0||Threshold for significance at 0.05 level.|MMRM|||||72.0|-120.5|0.6204
73874423|NCT03201419|147290643|SUPERIORITY||Mean Difference|2.2||||0.966|TWO_SIDED|95.0|-100.1|104.6||Threshold for significance at 0.05 level.|MMRM|||||104.6|-100.1|0.9660
73874424|NCT03201419|147290643|SUPERIORITY||Mean Difference|3.3||||0.9275|TWO_SIDED|95.0|-67.4|73.9||Threshold for significance at 0.05 level.|MMRM|||||73.9|-67.4|0.9275
73874425|NCT03201419|147290644|SUPERIORITY||Mean Difference|15.7||||0.5964|TWO_SIDED|95.0|-42.7|74.2||Threshold for significance at 0.05 level.|MMRM|||||74.2|-42.7|0.5964
73874426|NCT03201419|147290644|SUPERIORITY||Mean Difference|-2.8||||0.9418|TWO_SIDED|95.0|-78.5|72.9||Threshold for significance at 0.05 level.|MMRM|||||72.9|-78.5|0.9418
73874427|NCT03201419|147290644|SUPERIORITY||Mean Difference|18.0||||0.6452|TWO_SIDED|95.0|-58.8|94.7||Threshold for significance at 0.05 level.|MMRM|||||94.7|-58.8|0.6452
73874428|NCT03201419|147290644|SUPERIORITY||Mean Difference|-51.3||||0.2565|TWO_SIDED|95.0|-140.2|37.6||Threshold for significance at 0.05 level.|MMRM|||||37.6|-140.2|0.2565
73874429|NCT03201419|147290644|OTHER||Mean Difference|-21.6||||0.6605|TWO_SIDED|95.0|-118.6|75.4||Threshold for significance at 0.05 level.|MMRM|||||75.4|-118.6|0.6605
73874430|NCT03201419|147290644|SUPERIORITY||Mean Difference|3.4||||0.9191|TWO_SIDED|95.0|-62.6|69.4||Threshold for significance at 0.05 level.|MMRM|||||69.4|-62.6|0.9191
73874431|NCT03201419|147290645|SUPERIORITY||Mean Difference|17.52|||||TWO_SIDED|95.0|-6.19|62.09||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||62.09|-6.19|
73874432|NCT03201419|147290645|SUPERIORITY||Mean Difference|12.78|||||TWO_SIDED|95.0|-0.73|55.89||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||55.89|-0.73|
73874433|NCT03201419|147290645|SUPERIORITY||Mean Difference|8.5|||||TWO_SIDED|95.0|-0.14|47.28||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||47.28|-0.14|
73874434|NCT03201419|147290645|SUPERIORITY||Mean Difference|3.29|||||TWO_SIDED|95.0|-0.01|28.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||28.07|-0.01|
73874435|NCT03201419|147290645|SUPERIORITY||Mean Difference|1.74|||||TWO_SIDED|95.0|0.0|17.9||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||17.90|-0.00|
73874436|NCT03201419|147290645|SUPERIORITY||Mean Difference|0.68|||||TWO_SIDED|95.0|0.0|7.55||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||7.55|-0.00|
73983933|NCT03082196|147513288|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.037|TWO_SIDED|95.0|-1.9|-0.1|||t-test, 2 sided||The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a lower caries increment in the test varnish as compared to the standard varnish.|||-0.1|-1.9|0.037
73983934|NCT03082196|147513289|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.062|TWO_SIDED|95.0|-1.5|0.1|||t-test, 2 sided||The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a lower caries increment in the test varnish as compared to the standard varnish.|||0.1|-1.5|0.062
73983935|NCT03082196|147513290|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.11|TWO_SIDED|95.0|-0.5|0.1|||t-test, 2 sided||"The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a happier response in the test varnish as compared to the standard varnish."|||0.1|-0.5|0.11
73983936|NCT03082196|147513291|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.74|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided||"The direction of the comparison (difference) is the test varnish to the standard varnish. A positive value for the difference indicates an unhappier response in the test varnish as compared to the standard varnish."|||0.3|-0.2|0.74
73983937|NCT01403805|147513292|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Fisher's test 'Vaccine' versus 'Oral Care and Vaccines' and 'phumonia' and 'not pneumonia'|Fisher Exact|||The results were analyzed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.||||<0.001
73983938|NCT01403805|147513293|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Fisher Exact|||The results are expressed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.||||0.05
73983939|NCT01695993|147513298|OTHER|Primary Analysis: The Primary Aim to determine whether acupressure bands provided with efficacy-enhancing supplementary material are more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral supplementary material was examined using ANCOVA with Peak Nausea after the first chemotherapy as the response, Arm (Arms 2 and 3) as the factor and expectancy of acupressure bands as the covariate.|Mean Difference (Net)|0.03|STANDARD_DEVIATION|1.9||0.05|TWO_SIDED|||||Not adjusted|ANCOVA|||||||.05
73983940|NCT01072396|147513341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0087||95.0|0.02|0.11||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - crossover design||0.11|0.02|0.0087
73874437|NCT03201419|147290646|SUPERIORITY||Mean Difference|-0.173||||0.0196|TWO_SIDED|95.0|-0.318|-0.028||Threshold for significance at 0.05 level.|MMRM|||||-0.028|-0.318|0.0196
73983941|NCT01072396|147513342|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.0685||||0.067||95.0|0.9953|1.147||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design||1.1470|0.9953|0.0670
73983942|NCT01072396|147513343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2059||||0.2417||95.0|-0.5527|0.1408||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design||0.1408|-0.5527|0.2417
73983943|NCT05319756|147513355|SUPERIORITY||Mean Difference (Final Values)|32.8|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|ONE_SIDED|95.0|26.1||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 =15"|||26.1|<.0001
73983944|NCT05319756|147513355|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|4.46||0.1041|ONE_SIDED|95.0||1.7|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||1.7||0.1041
73983945|NCT05319756|147513355|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|4.46||0.3373|ONE_SIDED|95.0||5.5|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||5.5||0.3373
73983946|NCT05319756|147513355|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|ONE_SIDED|95.0||-6.3|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG \>0.2(μC - 50)"||-6.3||<.0001
73983947|NCT05319756|147513355|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001|ONE_SIDED|95.0||-0.6|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG \>0.2(μC - 50)"||-0.6||<0.0001
73983948|NCT05319756|147513355|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|4.0||0.0232|ONE_SIDED|95.0||9.6|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μG - μP ≥ δ2 versus Ha: μG - μP \< δ2 where δ2 =11"||9.6||0.0232
73983949|NCT05319756|147513355|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|4.01||0.2767|ONE_SIDED|95.0||15.2|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μG - μP ≥ δ2 versus Ha: μG - μP \< δ2 where δ2 =11."||15.2||0.2767
73874438|NCT03201419|147290646|SUPERIORITY||Mean Difference|-0.233||||0.0167|TWO_SIDED|95.0|-0.423|-0.043||Threshold for significance at 0.05 level.|MMRM|||||-0.043|-0.423|0.0167
73874439|NCT03201419|147290646|SUPERIORITY||Mean Difference|-0.208||||0.0352|TWO_SIDED|95.0|-0.401|-0.015||Threshold for significance at 0.05 level.|MMRM|||||-0.015|-0.401|0.0352
73983950|NCT05319756|147513357|OTHER||Mean Difference (Final Values)|267.1|STANDARD_ERROR_OF_MEAN|83.688||0.0016|TWO_SIDED|90.0|128.8|405.4|||Mixed Models Analysis|||||405.4|128.8|0.0016
73983951|NCT05319756|147513357|OTHER||Mean Difference (Final Values)|29.19|STANDARD_ERROR_OF_MEAN|83.688||0.7276|TWO_SIDED|90.0|-109.0|167.5|||Mixed Models Analysis|||||167.5|-109|0.7276
73874440|NCT03201419|147290646|SUPERIORITY||Mean Difference|-0.057||||0.6402|TWO_SIDED|95.0|-0.295|0.182||Threshold for significance at 0.05 level.|MMRM|||||0.182|-0.295|0.6402
73874441|NCT03201419|147290646|SUPERIORITY||Mean Difference|-0.121||||0.3602|TWO_SIDED|95.0|-0.381|0.139||Threshold for significance at 0.05 level.|MMRM|||||0.139|-0.381|0.3602
73983952|NCT05319756|147513357|OTHER||Mean Difference (Final Values)|50.41|STANDARD_ERROR_OF_MEAN|83.785||0.5481|TWO_SIDED|90.0|-88.0|188.9|||Mixed Models Analysis|||||188.9|-88.0|0.5481
73983953|NCT05319756|147513357|OTHER||Mean Difference (Final Values)|350.7|STANDARD_ERROR_OF_MEAN|84.023|<|0.0001|TWO_SIDED|90.0|211.8|489.5|||Mixed Models Analysis|||||489.5|211.8|<0.0001
73983954|NCT05319756|147513357|OTHER||Mean Difference (Final Values)|364.4|STANDARD_ERROR_OF_MEAN|83.785|<|0.0001|TWO_SIDED|90.0|225.9|502.8|||Mixed Models Analysis|||||502.8|225.9|<0.0001
73983955|NCT05319756|147513357|OTHER||Mean Difference (Final Values)|-238.0|STANDARD_ERROR_OF_MEAN|83.785||0.005|TWO_SIDED|90.0|-376.0|-99.4|||Mixed Models Analysis|||||-99.4|-376|0.0050
73983956|NCT05319756|147513357|OTHER||Mean Difference (Final Values)|-217.0|STANDARD_ERROR_OF_MEAN|84.023||0.0106|TWO_SIDED|90.0|-356.0|-77.8|||Mixed Models Analysis|||||-77.8|-356|0.0106
73983957|NCT05319756|147513357|OTHER||Mean Difference (Final Values)|83.6|STANDARD_ERROR_OF_MEAN|83.785||0.3196|TWO_SIDED|90.0|-54.9|222.1|||Mixed Models Analysis|||||222.1|-54.9|0.3196
73983958|NCT05319756|147513357|OTHER||Mean Difference (Final Values)|97.29|STANDARD_ERROR_OF_MEAN|83.688||0.2464|TWO_SIDED|90.0|-41.0|235.6|||Mixed Models Analysis|||||235.6|-41.0|0.2464
73983959|NCT05319756|147513363|OTHER||Mean Difference (Final Values)|64.67|STANDARD_ERROR_OF_MEAN|7.581|<|0.0001|TWO_SIDED|90.0|52.15|77.2|||Mixed Models Analysis|||||77.20|52.15|<.0001
73983960|NCT05319756|147513363|OTHER||Mean Difference (Final Values)|14.66|STANDARD_ERROR_OF_MEAN|7.581||0.0546|TWO_SIDED|90.0|2.13|27.1|||Mixed Models Analysis|||||27.1|2.13|0.0546
73983961|NCT05319756|147513363|OTHER||Mean Difference (Final Values)|11.58|STANDARD_ERROR_OF_MEAN|7.589||0.1286|TWO_SIDED|90.0|-0.96|24.12|||Mixed Models Analysis|||||24.12|-0.96|0.1286
73983962|NCT05319756|147513363|OTHER||Mean Difference (Final Values)|68.99|STANDARD_ERROR_OF_MEAN|7.611|<|0.0001|TWO_SIDED|90.0|56.42|81.57|||Mixed Models Analysis|||||81.57|56.42|<.0001
73874442|NCT03201419|147290646|SUPERIORITY||Mean Difference|0.074||||0.4018|TWO_SIDED|95.0|-0.099|0.247||Threshold for significance at 0.05 level.|MMRM|||||0.247|-0.099|0.4018
73874443|NCT03201419|147290647|SUPERIORITY||Mean Difference|-0.133||||0.1354|TWO_SIDED|95.0|-0.308|0.042||Threshold for significance at 0.05 level.|MMRM|||||0.042|-0.308|0.1354
73983963|NCT05319756|147513363|OTHER||Mean Difference (Final Values)|76.37|STANDARD_ERROR_OF_MEAN|7.589|<|0.0001|TWO_SIDED|90.0|63.83|88.91|||Mixed Models Analysis|||||88.91|63.83|<.0001
73983964|NCT05319756|147513363|OTHER||Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|7.589|<|0.0001|TWO_SIDED|90.0|-62.6|-37.5|||Mixed Models Analysis|||||-37.5|-62.6|<.0001
73983965|NCT05319756|147513363|OTHER||Mean Difference (Final Values)|-53.1|STANDARD_ERROR_OF_MEAN|7.611|<|0.0001|TWO_SIDED|90.0|-65.7|-40.5|||Mixed Models Analysis|||||-40.5|-65.7|<.0001
73874444|NCT03201419|147290647|SUPERIORITY||Mean Difference|-0.091||||0.4238|TWO_SIDED|95.0|-0.315|0.133||Threshold for significance at 0.05 level.|MMRM|||||0.133|-0.315|0.4238
73874445|NCT03201419|147290647|SUPERIORITY||Mean Difference|-0.22||||0.0574|TWO_SIDED|95.0|-0.446|0.007||Threshold for significance at 0.05 level.|MMRM|||||0.007|-0.446|0.0574
73874446|NCT03201419|147290647|SUPERIORITY||Mean Difference|0.058||||0.6579|TWO_SIDED|95.0|-0.199|0.315||Threshold for significance at 0.05 level.|MMRM|||||0.315|-0.199|0.6579
73874447|NCT03201419|147290647|SUPERIORITY||Mean Difference|-0.17||||0.2337|TWO_SIDED|95.0|-0.45|0.11||Threshold for significance at 0.05 level.|MMRM|||||0.110|-0.450|0.2337
73874448|NCT03201419|147290647|SUPERIORITY||Mean Difference|-0.136||||0.1639|TWO_SIDED|95.0|-0.328|0.056||Threshold for significance at 0.05 level.|MMRM|||||0.056|-0.328|0.1639
73983966|NCT05319756|147513363|OTHER||Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|7.589||0.5699|TWO_SIDED|90.0|-8.22|16.86|||Mixed Models Analysis|||||16.86|-8.22|0.5699
73983967|NCT05319756|147513363|OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|7.581||0.1243|TWO_SIDED|90.0|-0.83|24.23|||Mixed Models Analysis|||||24.23|-0.83|0.1243
73983968|NCT05319756|147513365|OTHER||Mean Difference (Final Values)|286.7|STANDARD_ERROR_OF_MEAN|50.879|<|0.0001|TWO_SIDED|90.0|202.6|370.8|||Mixed Models Analysis|||||370.8|202.6|<.0001
73983969|NCT05319756|147513365|OTHER||Mean Difference (Final Values)|53.85|STANDARD_ERROR_OF_MEAN|50.879||0.2912|TWO_SIDED|90.0|-30.2|137.9|||Mixed Models Analysis|||||137.9|-30.2|0.2912
73983970|NCT05319756|147513365|OTHER||Mean Difference (Final Values)|97.8|STANDARD_ERROR_OF_MEAN|50.938||0.0563|TWO_SIDED|90.0|13.62|182.0|||Mixed Models Analysis|||||182.0|13.62|0.0563
73983971|NCT05319756|147513365|OTHER||Mean Difference (Final Values)|484.5|STANDARD_ERROR_OF_MEAN|51.083|<|0.0001|TWO_SIDED|90.0|400.1|569.0|||Mixed Models Analysis|||||569.0|400.1|<.0001
73983972|NCT05319756|147513365|OTHER||Mean Difference (Final Values)|396.6|STANDARD_ERROR_OF_MEAN|50.938|<|0.0001|TWO_SIDED|90.0|312.4|480.8|||Mixed Models Analysis|||||480.8|312.4|<.0001
73983973|NCT05319756|147513365|OTHER||Mean Difference (Final Values)|-233.0|STANDARD_ERROR_OF_MEAN|50.938|<|0.0001|TWO_SIDED|90.0|-317.0|-149.0|||Mixed Models Analysis|||||-149|-317|<.0001
73983974|NCT05319756|147513365|OTHER||Mean Difference (Final Values)|-189.0|STANDARD_ERROR_OF_MEAN|51.083||0.0003|TWO_SIDED|90.0|-273.0|-105.0|||Mixed Models Analysis|||||-105|-273|0.0003
73983975|NCT05319756|147513365|OTHER||Mean Difference (Final Values)|197.8|STANDARD_ERROR_OF_MEAN|50.938||0.0001|TWO_SIDED|90.0|113.7|282.0|||Mixed Models Analysis|||||282.0|113.7|0.0001
73983976|NCT05319756|147513365|OTHER||Mean Difference (Final Values)|109.9|STANDARD_ERROR_OF_MEAN|50.879||0.032|TWO_SIDED|90.0|25.8|194.0|||Mixed Models Analysis|||||194.0|25.80|0.0320
73983977|NCT05319756|147513366|OTHER||Mean Difference (Final Values)|18.73|STANDARD_ERROR_OF_MEAN|2.276|<|0.0001|TWO_SIDED|90.0|14.98|22.48|||Mixed Models Analysis|||||22.48|14.98|<0.0001
73983978|NCT05319756|147513366|OTHER||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|2.302||0.5056|TWO_SIDED|90.0|-2.03|5.56|||Mixed Models Analysis|||||5.56|-2.03|0.5056
73983979|NCT05319756|147513366|OTHER||Mean Difference (Final Values)|4.62|STANDARD_ERROR_OF_MEAN|2.307||0.076|TWO_SIDED|90.0|0.82|8.42|||Mixed Models Analysis|||||8.42|0.82|0.0760
73983980|NCT05319756|147513366|OTHER||Mean Difference (Final Values)|25.73|STANDARD_ERROR_OF_MEAN|2.315|<|0.0001|TWO_SIDED|90.0|21.92|29.54|||Mixed Models Analysis|||||29.54|21.92|<0.0001
73983981|NCT05319756|147513366|OTHER||Mean Difference (Final Values)|24.42|STANDARD_ERROR_OF_MEAN|2.27|<|0.0001|TWO_SIDED|90.0|20.68|28.16|||Mixed Models Analysis|||||28.16|20.68|<0.0001
73983982|NCT05319756|147513366|OTHER||Mean Difference (Final Values)|-17.0|STANDARD_ERROR_OF_MEAN|2.297|<|0.0001|TWO_SIDED|90.0|-20.8|-13.2|||Mixed Models Analysis|||||-13.2|-20.8|<0.0001
73983983|NCT05319756|147513366|OTHER||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.299|<|0.0001|TWO_SIDED|90.0|-17.9|-10.3|||Mixed Models Analysis|||||-10.3|-17.9|<0.0001
73874449|NCT03201419|147290648|SUPERIORITY||Mean Difference|-87.2||||0.047|TWO_SIDED|95.0|-173.2|-1.2|||MMRM|||||-1.2|-173.2|0.0470
73874450|NCT03201419|147290648|SUPERIORITY||Mean Difference|-130.2||||0.0237|TWO_SIDED|95.0|-242.9|-17.6|||MMRM|||||-17.6|-242.9|0.0237
74034040|NCT03342469|147620946|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
73874451|NCT03201419|147290648|SUPERIORITY||Mean Difference|-110.8||||0.0569|TWO_SIDED|95.0|-224.9|3.3|||MMRM|||||3.3|-224.9|0.0569
73874452|NCT03201419|147290648|SUPERIORITY||Mean Difference|-23.9||||0.7383|TWO_SIDED|95.0|-164.8|117.0|||MMRM|||||117.0|-164.8|0.7383
73874453|NCT03201419|147290648|SUPERIORITY||Mean Difference|-71.0||||0.3626|TWO_SIDED|95.0|-224.3|82.3|||MMRM|||||82.3|-224.3|0.3626
73983984|NCT05319756|147513366|OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|2.298||0.0024|TWO_SIDED|90.0|3.22|10.79|||Mixed Models Analysis|||||10.79|3.22|0.0024
73983985|NCT05319756|147513366|OTHER||Mean Difference (Final Values)|5.69|STANDARD_ERROR_OF_MEAN|2.255||0.0118|TWO_SIDED|90.0|1.98|9.41|||Mixed Models Analysis|||||9.41|1.98|0.0118
73983986|NCT05319756|147513367|OTHER||Mean Difference (Final Values)|20.31|STANDARD_ERROR_OF_MEAN|2.246|<|0.0001|TWO_SIDED|90.0|16.61|24.01|||Mixed Models Analysis|||||24.01|16.61|<0.0001
73983987|NCT05319756|147513367|OTHER||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|2.271||0.2439|TWO_SIDED|90.0|-1.09|6.39|||Mixed Models Analysis|||||6.39|-1.09|0.2439
73983988|NCT05319756|147513367|OTHER||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|2.276||0.0044|TWO_SIDED|90.0|2.75|10.25|||Mixed Models Analysis|||||10.25|2.75|0.0044
73983989|NCT05319756|147513367|OTHER||Mean Difference (Final Values)|24.15|STANDARD_ERROR_OF_MEAN|2.284|<|0.0001|TWO_SIDED|90.0|20.39|27.91|||Mixed Models Analysis|||||27.91|20.39|<0.0001
73983990|NCT05319756|147513367|OTHER||Mean Difference (Final Values)|28.19|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|90.0|24.5|31.88|||Mixed Models Analysis|||||31.88|24.50|<0.0001
73983991|NCT05319756|147513367|OTHER||Mean Difference (Final Values)|-17.7|STANDARD_ERROR_OF_MEAN|2.266|<|0.0001|TWO_SIDED|90.0|-21.4|-13.9|||Mixed Models Analysis|||||-13.9|-21.4|<0.0001
73983992|NCT05319756|147513367|OTHER||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|2.268|<|0.0001|TWO_SIDED|90.0|-17.5|-10.1|||Mixed Models Analysis|||||-10.1|-17.5|<0.0001
73983993|NCT05319756|147513367|OTHER||Mean Difference (Final Values)|3.84|STANDARD_ERROR_OF_MEAN|2.267||0.0907|TWO_SIDED|90.0|0.11|7.57|||Mixed Models Analysis|||||7.57|0.11|0.0907
73983994|NCT05319756|147513367|OTHER||Mean Difference (Final Values)|7.88|STANDARD_ERROR_OF_MEAN|2.225||0.0004|TWO_SIDED|90.0|4.22|11.55|||Mixed Models Analysis|||||11.55|4.22|0.0004
73983995|NCT05319756|147513368|OTHER||Mean Difference (Final Values)|25.37|STANDARD_ERROR_OF_MEAN|1.528|<|0.0001|TWO_SIDED|90.0|22.86|27.88|||Mixed Models Analysis|||||27.88|22.86|<0.0001
73983996|NCT05319756|147513368|OTHER||Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.529||0.0189|TWO_SIDED|90.0|1.08|6.11|||Mixed Models Analysis|||||6.11|1.08|0.0189
73983997|NCT05319756|147513368|OTHER||Mean Difference (Final Values)|6.18|STANDARD_ERROR_OF_MEAN|1.536|<|0.0001|TWO_SIDED|90.0|3.66|8.71|||Mixed Models Analysis|||||8.71|3.66|<0.0001
73983998|NCT05319756|147513368|OTHER||Mean Difference (Final Values)|32.18|STANDARD_ERROR_OF_MEAN|1.537|<|0.0001|TWO_SIDED|90.0|29.65|34.71|||Mixed Models Analysis|||||34.71|29.65|<0.0001
73983999|NCT05319756|147513368|OTHER||Mean Difference (Final Values)|30.17|STANDARD_ERROR_OF_MEAN|1.525|<|0.0001|TWO_SIDED|90.0|27.66|32.68|||Mixed Models Analysis|||||32.68|27.66|<0.0001
73874454|NCT03201419|147290648|SUPERIORITY||Mean Difference|23.4||||0.6524|TWO_SIDED|95.0|-78.9|125.7|||MMRM|||||125.7|-78.9|0.6524
73874455|NCT03201419|147290649|SUPERIORITY||Mean Difference|-49.5||||0.3273|TWO_SIDED|95.0|-148.9|49.9||Threshold for significance at 0.05 level.|MMRM|||||49.9|-148.9|0.3273
73874456|NCT03201419|147290649|SUPERIORITY||Mean Difference|-74.6||||0.25|TWO_SIDED|95.0|-202.0|52.9||Threshold for significance at 0.05 level.|MMRM|||||52.9|-202.0|0.2500
73874457|NCT03201419|147290649|SUPERIORITY||Mean Difference|-93.5||||0.1537|TWO_SIDED|95.0|-222.3|35.2||Threshold for significance at 0.05 level.|MMRM|||||35.2|-222.3|0.1537
73874458|NCT03201419|147290649|SUPERIORITY||Mean Difference|33.6||||0.6515|TWO_SIDED|95.0|-113.1|180.3||Threshold for significance at 0.05 level.|MMRM|||||180.3|-113.1|0.6515
73984000|NCT05319756|147513368|OTHER||Mean Difference (Final Values)|-21.8|STANDARD_ERROR_OF_MEAN|1.522|<|0.0001|TWO_SIDED|90.0|-24.3|-19.3|||Mixed Models Analysis|||||-19.3|-24.3|<0.0001
73984001|NCT05319756|147513368|OTHER||Mean Difference (Final Values)|-19.2|STANDARD_ERROR_OF_MEAN|1.53|<|0.0001|TWO_SIDED|90.0|-21.7|-16.7|||Mixed Models Analysis|||||-16.7|-21.7|<0.0001
73984002|NCT05319756|147513368|OTHER||Mean Difference (Final Values)|6.81|STANDARD_ERROR_OF_MEAN|1.524|<|0.0001|TWO_SIDED|90.0|4.3|9.31|||Mixed Models Analysis|||||9.31|4.30|<0.0001
73984003|NCT05319756|147513368|OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.514||0.0015|TWO_SIDED|90.0|2.31|7.29|||Mixed Models Analysis|||||7.29|2.31|0.0015
73984004|NCT05319756|147513369|OTHER||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|0.743|<|0.0001|TWO_SIDED|90.0|3.01|5.45|||Mixed Models Analysis|||||5.45|3.01|<.0001
74089678|NCT00904748|147732120|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|98.68|||||TWO_SIDED|90.0|92.03|105.82|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||105.82|92.03|
73874459|NCT03201419|147290649|SUPERIORITY||Mean Difference|-75.7||||0.3506|TWO_SIDED|95.0|-235.3|83.9||Threshold for significance at 0.05 level.|MMRM|||||83.9|-235.3|0.3506
73874460|NCT03201419|147290649|SUPERIORITY||Mean Difference|-85.4||||0.1255|TWO_SIDED|95.0|-194.8|24.1||Threshold for significance at 0.05 level.|MMRM|||||24.1|-194.8|0.1255
73874461|NCT01657292|147290651|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||1-sided, significance level = 0.025|Binomial test|||"All patients received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: s0 ≤0.5 and H1: s0 \>0.5 (with s0=rate of superiority of Oleogel-S10)."||||<0.0001
73874462|NCT00650845|147290662|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-7.9|6.7||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%Confidence Interval (CI) of the difference (non-enhanced - Dotarem®-enhanced) was \[-7.9%; +6.7%\]||6.7|-7.9|
73874463|NCT00650845|147290663|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.||||0.291
73956068|NCT00991276|147447821|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|1.84||0.5815|TWO_SIDED|95.0|-4.66|2.63||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.63|-4.66|0.5815
73956069|NCT00991276|147447822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.72|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|95.0|22.02|43.42||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||43.42|22.02|<0.0001
73956070|NCT00991276|147447822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|25.86|STANDARD_ERROR_OF_MEAN|5.37|<|0.0001|TWO_SIDED|95.0|15.22|36.49||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||36.49|15.22|<0.0001
73956071|NCT00991276|147447822|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.86|STANDARD_ERROR_OF_MEAN|5.33||0.2005|TWO_SIDED|95.0|-3.69|17.42||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||17.42|-3.69|0.2005
73956072|NCT00991276|147447823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|4.57|9.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||9.02|4.57|<0.0001
73956073|NCT00991276|147447823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.24|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|3.02|7.45||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||7.45|3.02|<0.0001
73956074|NCT00991276|147447823|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.56|STANDARD_ERROR_OF_MEAN|1.11||0.1622|TWO_SIDED|95.0|-0.64|3.75||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.75|-0.64|0.1622
73984005|NCT05319756|147513369|OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.743||0.3933|TWO_SIDED|90.0|-0.59|1.86|||Mixed Models Analysis|||||1.86|-0.59|0.3933
73984006|NCT05319756|147513369|OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.747||0.2916|TWO_SIDED|90.0|-0.44|2.02|||Mixed Models Analysis|||||2.02|-0.44|0.2916
73984007|NCT05319756|147513369|OTHER||Mean Difference (Final Values)|3.92|STANDARD_ERROR_OF_MEAN|0.748|<|0.0001|TWO_SIDED|90.0|2.69|5.15|||Mixed Models Analysis|||||5.15|2.69|<.0001
73984008|NCT05319756|147513369|OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|0.742|<|0.0001|TWO_SIDED|90.0|2.0|4.44|||Mixed Models Analysis|||||4.44|2.00|<.0001
73874464|NCT00650845|147290664|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-14.1|8.9||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%CI of the difference (non-enhanced - Dotarem®-enhanced) was \[-14.1%; +8.9%\]||8.9|-14.1|
73874465|NCT00650845|147290665|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.||||0.040
73874466|NCT00650845|147290666|SUPERIORITY_OR_OTHER|||||||0.301|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.||||0.301
73874467|NCT00650845|147290667|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.||||0.051
73874468|NCT04177212|147290681|OTHER||||||<|0.0001||||||P-value for testing null-hypothesis that response of Pooled Group was less or equal to 50 percent (%).|One-sided binomial test|||Between Groups calculation were not done because comparing Groups A and B was not part of the objective of this investigation.||||< 0.0001
73874469|NCT04177212|147290682|OTHER|||||||0.0003||||||P-value for testing null-hypothesis that response of Pooled Group was less or equal to 50%.|One-sided binomial test|||Between Groups calculation were not done because comparing Groups A and B was not part of the objective of this investigation.||||0.0003
73874470|NCT00857857|147290703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.1033|||TWO_SIDED|95.0|0.031|0.449||||||||0.449|0.031|
73874471|NCT00857857|147290703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.265|STANDARD_ERROR_OF_MEAN|0.1048|||TWO_SIDED|95.0|0.053|0.477||||||||0.477|0.053|
73874472|NCT00857857|147290703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.456|STANDARD_ERROR_OF_MEAN|0.0993|||TWO_SIDED|95.0|0.255|0.657||||||||0.657|0.255|
73874473|NCT00857857|147290703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.526|STANDARD_ERROR_OF_MEAN|0.1025|||TWO_SIDED|95.0|0.319|0.733||||||||0.733|0.319|
73984009|NCT05319756|147513369|OTHER||Mean Difference (Final Values)|-3.59|STANDARD_ERROR_OF_MEAN|0.74|<|0.0001|TWO_SIDED|90.0|-4.81|-2.38|||Mixed Models Analysis|||||-2.38|-4.81|<.0001
73984010|NCT05319756|147513369|OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.744|<|0.0001|TWO_SIDED|90.0|-4.66|-2.22|||Mixed Models Analysis|||||-2.22|-4.66|<.0001
73984011|NCT05319756|147513369|OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.741||0.6765|TWO_SIDED|90.0|-1.53|0.91|||Mixed Models Analysis|||||0.91|-1.53|0.6765
73984012|NCT05319756|147513369|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.737||0.1712|TWO_SIDED|90.0|-2.22|0.2|||Mixed Models Analysis|||||0.20|-2.22|0.1712
73984013|NCT05319756|147513370|OTHER||Mean Difference (Final Values)|24.7|STANDARD_ERROR_OF_MEAN|1.526|<|0.0001|TWO_SIDED|90.0|22.19|27.21|||Mixed Models Analysis|||||27.21|22.19|<.0001
73984014|NCT05319756|147513370|OTHER||Mean Difference (Final Values)|2.87|STANDARD_ERROR_OF_MEAN|1.527||0.0606|TWO_SIDED|90.0|0.35|5.38|||Mixed Models Analysis|||||5.38|0.35|0.0606
73984015|NCT05319756|147513370|OTHER||Mean Difference (Final Values)|4.11|STANDARD_ERROR_OF_MEAN|1.534||0.0074|TWO_SIDED|90.0|1.59|6.64|||Mixed Models Analysis|||||6.64|1.59|0.0074
73984016|NCT05319756|147513370|OTHER||Mean Difference (Final Values)|30.58|STANDARD_ERROR_OF_MEAN|1.536|<|0.0001|TWO_SIDED|90.0|28.05|33.1|||Mixed Models Analysis|||||33.10|28.05|<.0001
73984017|NCT05319756|147513370|OTHER||Mean Difference (Final Values)|29.99|STANDARD_ERROR_OF_MEAN|1.524|<|0.0001|TWO_SIDED|90.0|27.48|32.5|||Mixed Models Analysis|||||32.50|27.48|<.0001
73984018|NCT05319756|147513370|OTHER||Mean Difference (Final Values)|-21.8|STANDARD_ERROR_OF_MEAN|1.521|<|0.0001|TWO_SIDED|90.0|-24.3|-19.3|||Mixed Models Analysis|||||-19.3|-24.3|<.0001
73984019|NCT05319756|147513370|OTHER||Mean Difference (Final Values)|-20.6|STANDARD_ERROR_OF_MEAN|1.529|<|0.0001|TWO_SIDED|90.0|-23.1|-18.1|||Mixed Models Analysis|||||-18.1|-23.1|<.0001
73984020|NCT05319756|147513370|OTHER||Mean Difference (Final Values)|5.88|STANDARD_ERROR_OF_MEAN|1.523||0.0001|TWO_SIDED|90.0|3.37|8.38|||Mixed Models Analysis|||||8.38|3.37|0.0001
73984021|NCT05319756|147513370|OTHER||Mean Difference (Final Values)|5.29|STANDARD_ERROR_OF_MEAN|1.513||0.0005|TWO_SIDED|90.0|2.8|7.78|||Mixed Models Analysis|||||7.78|2.80|0.0005
73984022|NCT04908800|147513394|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.88|||||TWO_SIDED|90.0|1.74|2.04|||||"Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect.~Within-subject coefficient of variation was 10.7."|||2.04|1.74|
73874474|NCT00857857|147290704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.0975|||TWO_SIDED|95.0|0.013|0.407||||||||0.407|0.013|
73874475|NCT00857857|147290704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.0988|||TWO_SIDED|95.0|-0.046|0.354||||||||0.354|-0.046|
73984023|NCT04908800|147513395|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.68|||||TWO_SIDED|90.0|1.57|1.79|||||"Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect.~Within-subject coefficient of variation was 9.01."|||1.79|1.57|
73984024|NCT04908800|147513396|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.15|||||TWO_SIDED|90.0|1.09|1.21|||||Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect. Within-subject coefficient of variation was 7.18.|||1.21|1.09|
73984025|NCT04908800|147513401|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.971|||||TWO_SIDED|95.0|0.882|1.06|||||Between-subject geometric coefficient of variation was 26.1. Data were analyzed using a power model.|Dose Proportionality Assessment||1.06|0.882|
73984026|NCT04908800|147513401|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.01|||||TWO_SIDED|95.0|0.926|1.11|||||Geometric least squares mean was 600 (fasted) and 607 (fed). Within-subject coefficient of variation was 6.01. Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect.|Food Effect Assessment||1.11|0.926|
73984027|NCT04908800|147513401|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.06|||||TWO_SIDED|95.0|0.701|1.59|||||Geometric least squares mean was 600 (fasted male) and 634 (fasted female). Between subject coefficient of variation was 32.7. Data were analyzed using an ANOVA model which included actual treatment as a factor.|Sex Effect Assessment||1.59|0.701|
73984028|NCT04908800|147513402|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.977|||||TWO_SIDED|95.0|0.891|1.06|||||Between-subject geometric coefficient of variation was 25.4. Data were analyzed using a power model.|Dose Proportionality Assessment||1.06|0.891|
74089679|NCT00904748|147732120|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.23|||||TWO_SIDED|90.0|90.67|104.26|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||104.26|90.67|
73874476|NCT00857857|147290704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.303|STANDARD_ERROR_OF_MEAN|0.0937|||TWO_SIDED|95.0|0.113|0.492||||||||0.492|0.113|
73874477|NCT00857857|147290704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.404|STANDARD_ERROR_OF_MEAN|0.0966|||TWO_SIDED|95.0|0.209|0.599||||||||0.599|0.209|
73874478|NCT00857857|147290705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.1372|||TWO_SIDED|95.0|-0.302|0.253|||||Comparison of Minimum FEV1 between Placebo and GW870086 0.25 mg.|||0.253|-0.302|
73874479|NCT00857857|147290705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.106|STANDARD_ERROR_OF_MEAN|0.1391|||TWO_SIDED|95.0|-0.176|0.387|||||Comparison of Minimum FEV1 between Placebo and GW870086 1 mg.|||0.387|-0.176|
73984029|NCT04908800|147513402|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.0|||||TWO_SIDED|95.0|0.905|1.12|||||"Geometric least squares mean was 575 (fasted) and 578 (fed). Within-subject coefficient of variation was 7.05.~Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect."|Food Effect Assessment||1.12|0.905|
73984030|NCT04908800|147513402|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.04|||||TWO_SIDED|95.0|0.707|1.54|||||"Geometric least squares mean was 575 (fasted male) and 600 (fasted female). Between subject coefficient of variation was 31.1.~Data were analyzed using an ANOVA model which included actual treatment as a factor."|Sex Effect Assessment||1.54|0.707|
73984031|NCT04908800|147513403|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.989|||||TWO_SIDED|95.0|0.909|1.07|||||Between-subject geometric coefficient of variation was 23.0. Data were analyzed using a power model.|Dose Proportionality Assessment||1.07|0.909|
73984032|NCT04908800|147513403|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.948|||||TWO_SIDED|95.0|0.824|1.09|||||"Geometric least squares mean was 31.6 (fasted) and 30.0 (fed). Within-subject coefficient of variation was 9.44.~Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect."|Food Effect Assessment||1.09|0.824|
74089680|NCT00904748|147732121|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|80.83|||||TWO_SIDED|90.0|72.38|90.26|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||90.26|72.38|
73874480|NCT00857857|147290705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.239|STANDARD_ERROR_OF_MEAN|0.1319|||TWO_SIDED|95.0|-0.028|0.506|||||Comparison of Minimum FEV1 between Placebo and GW870086 3 mg.|||0.506|-0.028|
73874481|NCT00857857|147290705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.534|STANDARD_ERROR_OF_MEAN|0.1359|||TWO_SIDED|95.0|0.26|0.809|||||Comparison of Minimum FEV1 between Placebo and fluticasone propionate 0.25 mg BID.|||0.809|0.260|
73874482|NCT00857857|147290705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.0984|||TWO_SIDED|95.0|-0.145|0.253|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 0.25 mg.|||0.253|-0.145|
73874483|NCT00857857|147290705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.0998|||TWO_SIDED|95.0|-0.176|0.228|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 1 mg.|||0.228|-0.176|
73874484|NCT00857857|147290705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.0945|||TWO_SIDED|95.0|-0.011|0.371|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 3 mg.|||0.371|-0.011|
73874485|NCT00857857|147290705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.0978|||TWO_SIDED|95.0|0.153|0.548|||||Comparison of Weighted Mean FEV1 between Placebo and fluticasone propionate 0.25 mg BID.|||0.548|0.153|
73874486|NCT00857857|147290706|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.71|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.56|0.9||||||||0.90|0.56|
73874487|NCT00857857|147290706|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.66|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.53|0.82||||||||0.82|0.53|
73874488|NCT00857857|147290706|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.59|STANDARD_ERROR_OF_MEAN|0.112|||TWO_SIDED|95.0|0.47|0.74||||||||0.74|0.47|
73874489|NCT00857857|147290706|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.45|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.36|0.55||||||||0.55|0.36|
73984033|NCT04908800|147513403|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.23|||||TWO_SIDED|95.0|0.928|1.62|||||"Geometric least squares mean was 31.6 (fasted male) and 38.8 (fasted female). Between subject coefficient of variation was 22.0.~Data were analyzed using an ANOVA model which included actual treatment as a factor."|Sex Effect Assessment||1.62|0.928|
73984034|NCT04908800|147513408|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.11|||||TWO_SIDED|95.0|0.966|1.26|||||Between-subject geometric coefficient of variation was 26.9. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.26|0.966|
73984035|NCT04908800|147513410|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.12|||||TWO_SIDED|95.0|0.945|1.29|||||Between-subject geometric coefficient of variation was 32.1. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.29|0.945|
73984036|NCT04908800|147513411|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.1|||||TWO_SIDED|95.0|0.971|1.23|||||Between-subject geometric of coefficient variation was 23.2. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.23|0.971|
73874490|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.1086|||TWO_SIDED|95.0|-0.199|0.24|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 minutes|||0.240|-0.199|
73874491|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.164|STANDARD_ERROR_OF_MEAN|0.1285|||TWO_SIDED|95.0|-0.096|0.424|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 minutes|||0.424|-0.096|
73874492|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.024|STANDARD_ERROR_OF_MEAN|0.1526|||TWO_SIDED|95.0|-0.285|0.333|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 15 minutes|||0.333|-0.285|
73874493|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.1471|||TWO_SIDED|95.0|-0.229|0.366|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 20 minutes|||0.366|-0.229|
73874494|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.011|STANDARD_ERROR_OF_MEAN|0.1313|||TWO_SIDED|95.0|-0.277|0.254|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 30 minutes|||0.254|-0.277|
73984037|NCT05045638|147513426|OTHER||Ratio of GLSMs|1.6999|||||TWO_SIDED|90.0|1.186|2.4363||||||The ratios of geometric least squares means (GLSMs) and confidence intervals (CIs) were obtained by taking the exponential of the corresponding differences and CIs on the natural-log (ln) scale.||2.4363|1.1860|
73984038|NCT05045638|147513427|OTHER||Ratio of GLSMs|1.3389|||||TWO_SIDED|90.0|1.0334|1.7347||||||The ratios of GLSMs and CIs were obtained by taking the exponential of the corresponding differences and CIs on the ln scale.||1.7347|1.0334|
73984039|NCT05045638|147513428|OTHER||Ratio of GLSMs|1.3382|||||TWO_SIDED|90.0|0.9856|1.8169||||||The ratios of GLSMs and CIs were obtained by taking the exponential of the corresponding differences and CIs on the ln scale.||1.8169|0.9856|
73874495|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.269|0.302|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 45 minutes|||0.302|-0.269|
73874496|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.1265|||TWO_SIDED|95.0|-0.21|0.301|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1 hour|||0.301|-0.210|
73874497|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045|STANDARD_ERROR_OF_MEAN|0.1102|||TWO_SIDED|95.0|-0.178|0.268|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1.5 hours|||0.268|-0.178|
73874498|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.096|STANDARD_ERROR_OF_MEAN|0.0985|||TWO_SIDED|95.0|-0.103|0.295|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2 hours|||0.295|-0.103|
73874499|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045|STANDARD_ERROR_OF_MEAN|0.0826|||TWO_SIDED|95.0|-0.121|0.212|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2.5 hours|||0.212|-0.121|
73984040|NCT00348283|147513440|SUPERIORITY_OR_OTHER|||||||0.056||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|Because of the hierarchical testing scheme used for testing the ranked secondary endpoints, alpha level of 0.05 was used at each stage of testing.||ITT population: all subjects randomized at Week 4 who had at least 1 dose of blinded therapy. The sample-size (placebo = 65 subjects; adalimumab = 65 subjects) for the primary efficacy analysis was calculated using 88% power at 0.05 alpha level based on the assumption that 25% and 5% of subjects were without mucosal ulceration at Week 12 in adalimumab 40 mg eow and placebo groups, respectively. However, subjects without mucosal ulceration at Screening were excluded from the primary analysis.||||0.056
73984041|NCT00348283|147513441|SUPERIORITY_OR_OTHER|||||||0.021||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.||||0.021
73984042|NCT00348283|147513442|SUPERIORITY_OR_OTHER||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at Week 52 in the two treatment groups.||||<0.001
73874500|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.0832|||TWO_SIDED|95.0|-0.141|0.196|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3 hours|||0.196|-0.141|
73874501|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.0888|||TWO_SIDED|95.0|-0.138|0.221|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3.5 hours|||0.221|-0.138|
73874502|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.0934|||TWO_SIDED|95.0|-0.215|0.162|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4 hour|||0.162|-0.215|
73874503|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.1065|||TWO_SIDED|95.0|-0.076|0.354|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4.5 hours|||0.354|-0.076|
73874504|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.149|STANDARD_ERROR_OF_MEAN|0.0955|||TWO_SIDED|95.0|-0.044|0.342|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 hours|||0.342|-0.044|
73984043|NCT00348283|147513443|SUPERIORITY_OR_OTHER|||||||0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 52 in the two treatment groups.||||0.001
73984044|NCT00348283|147513444|SUPERIORITY_OR_OTHER|||||||0.15||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at both Week 12 and Week 52 in the two treatment groups.||||0.150
73984045|NCT00348283|147513445|SUPERIORITY_OR_OTHER||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.||||<0.001
73984046|NCT06312566|147513453|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 92.016% CI limits for Cmax,ss was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.9726|||||TWO_SIDED|92.016|0.9257|1.022|||Linear mixed model analysis|||||1.022|0.9257|
73984047|NCT06312566|147513454|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for AUC(tau) was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.9999|||||TWO_SIDED|92.016|0.9881|1.012||||||||1.012|0.9881|
73984048|NCT04736472|147513461|SUPERIORITY|||||||0.224|||||||Fisher Exact|||Severe TRAEs||||.224
73984049|NCT04736472|147513461|SUPERIORITY|||||||0.025|||||||Fisher Exact|||Severe TRAEs||||.025
73984050|NCT02971683|147513474|SUPERIORITY||Odds Ratio (OR)|1.8||||0.083|TWO_SIDED|95.0|0.9|3.5|||Regression, Logistic|||||3.5|0.9|0.083
74034041|NCT03342469|147620946|OTHER|||||||0.08||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||0.08
74034042|NCT03342469|147620946|OTHER|||||||0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1,14)= 4.55||Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||0.05
74039514|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0207|TWO_SIDED|95.0|-0.29|-0.02|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.29|0.0207
73874505|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.1005|||TWO_SIDED|95.0|-0.119|0.288|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5.5 hours|||0.288|-0.119|
73874506|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.212|STANDARD_ERROR_OF_MEAN|0.1122|||TWO_SIDED|95.0|-0.015|0.438|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6 hours|||0.438|-0.015|
73984051|NCT04206501|147513488|SUPERIORITY|||||||0.064||||||The rate of change in HF medications (beta-blocker, diuretic, and Sacubitril/Valsartan) was compared betweenICM Guidedand usual care control group using chi-square analysis.|Chi-squared|||Due to the unexpected low enrollment during COVID pandemic, we aimed to primarily focus the limited analysis/description on the primary endpoint and exploratory analysis related to QOL||||0.064
73984052|NCT02268526|147513490|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.891|||||TWO_SIDED|90.0|0.606|1.305||||||||1.305|0.606|
73984053|NCT02268526|147513490|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.941|||||TWO_SIDED|90.0|0.639|1.377||||||||1.377|0.639|
73984054|NCT00763919|147513506|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||<.001
73984055|NCT00763919|147513507|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.01
73984056|NCT00763919|147513508|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||<.001
73984057|NCT00763919|147513509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||<.001
73984058|NCT00763919|147513510|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<.001
73984059|NCT00763919|147513511|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.042
73984060|NCT00763919|147513512|SUPERIORITY_OR_OTHER|||||||0.044||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.044
73984061|NCT00763919|147513513|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.002
73984062|NCT00763919|147513514|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.001
73984063|NCT00763919|147513515|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.001
73984064|NCT00763919|147513516|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.001
73984065|NCT00763919|147513517|SUPERIORITY_OR_OTHER|||||||0.827||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.827
73984066|NCT00763919|147513518|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.002
73984067|NCT00763919|147513519|SUPERIORITY_OR_OTHER|||||||0.246||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.246
73984068|NCT00763919|147513520|SUPERIORITY_OR_OTHER|||||||0.101||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.101
73984069|NCT00763919|147513521|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.003
73984070|NCT00763919|147513522|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.096
73984071|NCT00763919|147513523|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.072
73984072|NCT00763919|147513524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<.001
73984073|NCT00763919|147513525|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.078
73984074|NCT00763919|147513526|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.002
74089681|NCT00904748|147732121|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|78.76|||||TWO_SIDED|90.0|70.53|87.96|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||87.96|70.53|
73984075|NCT00763919|147513527|SUPERIORITY_OR_OTHER|||||||0.562||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.562
73984076|NCT00763919|147513528|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.12
73984077|NCT03305458|147513535|SUPERIORITY||||||||||||||||||To determine if child and caregiver engagement is affected by overall SPARK use, a 2-level MLM (level-1 child, level-2 provider) will be used. Engagement scores will be calculated per child and caregiver participant. An aggregate engagement score will determine if there are differences across conditions (SPARK + TF CBT vs standard TF-CBT) while accounting for the nesting providers.|||
73984078|NCT03305458|147513536|SUPERIORITY||||||||||||||||||To determine if provider fidelity is affected by overall SPARK use, a 2-level MLM (level-1 child; level-2 provider) will be used. Fidelity will be measured by the TF-CBT TPOCS-S. Providers' overall use of the toolkit will be calculated per child participant and averaged across toolkit content. Fidelity scores will be calculated per child participant such that each provider will have three ratings. An aggregate fidelity score will determine if there are differences across conditions (SPARK + TF-CBT vs. standard TF-CBT) while accounting for the nesting of providers.|||
73984079|NCT03305458|147513537|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-to provider.|||
73984080|NCT03305458|147513538|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984081|NCT03305458|147513539|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984082|NCT03305458|147513540|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984083|NCT03305458|147513541|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984084|NCT03305458|147513542|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984085|NCT03305458|147513543|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
73984086|NCT03305458|147513544|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
73984087|NCT03305458|147513545|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
73984088|NCT03305458|147513546|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984089|NCT03305458|147513547|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984090|NCT03305458|147513548|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984091|NCT03305458|147513549|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984092|NCT03305458|147513550|SUPERIORITY||||||||||||||||||response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
73984093|NCT03305458|147513551|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984094|NCT03305458|147513552|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984095|NCT03305458|147513553|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984096|NCT03305458|147513554|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984097|NCT03305458|147513555|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
73984098|NCT05431543|147513557|SUPERIORITY||Odds Ratio (OR)|83.988|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
73984099|NCT05431543|147513557|SUPERIORITY||Odds Ratio (OR)|102.093|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
73984100|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6409||||||Hochberg's adjustment was used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6409
73984101|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0140
73984102|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4840
73984103|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4444||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4444
73874507|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.162|STANDARD_ERROR_OF_MEAN|0.1051|||TWO_SIDED|95.0|-0.051|0.374|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6.5 hours|||0.374|-0.051|
73984104|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8129||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8129
73984105|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1105||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.1105
73984106|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9582||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.9582
73984107|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1893||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.1893
73984108|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2924||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Hochberg's adjustment used for multiple comparisons adjustment||Week 5||||0.2924
73984109|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1897||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.1897
73984110|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6608||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."||||0.6608
73984111|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2148||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."||||0.2148
73984112|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.5290
73984113|NCT00141271|147513570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0811||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.0811
73984114|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.2287
73984115|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4734||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week1||||0.4734
73984116|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7401||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7401
73984117|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7904||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7904
73984118|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5274||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.5274
73984119|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1059||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.1059
73984120|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8871||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.8871
73984121|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6939|||||||Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.6939
74039515|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8399|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.11|0.8399
73984122|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1044||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.1044
73984123|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3132||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.3132
73984124|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6978||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6978
73984125|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3228||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.3228
73984126|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6432
73984127|NCT00141271|147513571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5989||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.5989
73984128|NCT00141271|147513572|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8921||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.8921
73984129|NCT00141271|147513572|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.4350
74039516|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0299|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.25|0.0299
74039517|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.29|-0.05|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.29|0.0060
73984130|NCT00141271|147513572|SUPERIORITY_OR_OTHER_LEGACY|||||||0.562||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.5620
73984131|NCT00141271|147513572|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6959||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6959
73984132|NCT00141271|147513572|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7865||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7865
73984133|NCT00141271|147513572|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7564
73984134|NCT00141271|147513573|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4327||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4327
73984135|NCT00141271|147513573|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7041||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7041
73984136|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2076||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.2076
73984137|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7449||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.7449
74034043|NCT03342469|147620946|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
73984138|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4399||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.4399
74034044|NCT03342469|147620946|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
73874508|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.1181|||TWO_SIDED|95.0|-0.017|0.461|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7 hour|||0.461|-0.017|
73874509|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.185|STANDARD_ERROR_OF_MEAN|0.1355|||TWO_SIDED|95.0|-0.089|0.458|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7.5 hours|||0.458|-0.089|
73984139|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7107||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7107
73874510|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.247|STANDARD_ERROR_OF_MEAN|0.1187|||TWO_SIDED|95.0|0.007|0.487|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8 hours|||0.487|0.007|
73984140|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4765||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.4765
73984141|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.2564
73984142|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8063||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.8063
73984143|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9855||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.9855
74039518|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.1974|TWO_SIDED|95.0|-0.24|0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.24|0.1974
73984144|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0599||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0599
73984145|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7364||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.7364
73984146|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6||||0.3048
73984147|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5139||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6||||0.5139
73984148|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9356||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9356
73984149|NCT00141271|147513574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9428
73984150|NCT00141271|147513575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3888||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.3888
73874511|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.244|STANDARD_ERROR_OF_MEAN|0.1313|||TWO_SIDED|95.0|-0.021|0.509|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8.5 hours|||0.509|-0.021|
73874512|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.1189|||TWO_SIDED|95.0|-0.086|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9 hours|||0.394|-0.086|
73984151|NCT00141271|147513575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3122||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.3122
73984152|NCT00141271|147513575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3323||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.3323
73984153|NCT00141271|147513575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8781||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.8781
73984154|NCT00141271|147513575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9485||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9485
73984155|NCT00141271|147513575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7331||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7331
73984156|NCT00141271|147513576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.4869
73984157|NCT00141271|147513576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5813||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.5813
73984158|NCT00141271|147513576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.3303
73984159|NCT00141271|147513576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1546||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.1546
73984160|NCT00141271|147513576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8982||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.8982
73984161|NCT00141271|147513576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3586
73984162|NCT00141271|147513577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0896||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.0896
73984163|NCT00141271|147513577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6534||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.6534
73984164|NCT00141271|147513577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.3270
73874513|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.175|STANDARD_ERROR_OF_MEAN|0.1085|||TWO_SIDED|95.0|-0.044|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9.5 hours|||0.394|-0.044|
73874514|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.085|STANDARD_ERROR_OF_MEAN|0.1024|||TWO_SIDED|95.0|-0.122|0.292|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 hours|||0.292|-0.122|
73956075|NCT00991276|147447830|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.18|-0.47||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.47|-1.18|<0.0001
73956076|NCT00991276|147447830|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.31|-0.6||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.60|-1.31|<0.0001
73956077|NCT00991276|147447830|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.4677|TWO_SIDED|95.0|-0.22|0.48||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.48|-0.22|0.4677
73956078|NCT00991276|147447831|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.32|STANDARD_ERROR_OF_MEAN|5.31|<|0.0001|TWO_SIDED|95.0|-35.83|-14.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-14.80|-35.83|<0.0001
73956079|NCT00991276|147447831|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.45|STANDARD_ERROR_OF_MEAN|5.27|<|0.0001|TWO_SIDED|95.0|-38.89|-18.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.02|-38.89|<0.0001
73956080|NCT00991276|147447831|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.14|STANDARD_ERROR_OF_MEAN|5.19||0.5461|TWO_SIDED|95.0|-7.13|13.4||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||13.40|-7.13|0.5461
73956081|NCT00991276|147447832|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.04|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|0.63|1.45||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.45|0.63|<0.0001
73956082|NCT00991276|147447832|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.65|1.46||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.46|0.65|<0.0001
73956083|NCT00991276|147447832|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9403|TWO_SIDED|95.0|-0.42|0.39||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.39|-0.42|0.9403
73956084|NCT00991276|147447833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.58|STANDARD_ERROR_OF_MEAN|3.26||0.0215|TWO_SIDED|95.0|-14.03|-1.14||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.14|-14.03|0.0215
73984165|NCT00141271|147513577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.4099
73984166|NCT00141271|147513577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6104||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6104
73984167|NCT00141271|147513577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9359||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9359
73984168|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6924||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6924
73984169|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0800
73956085|NCT00991276|147447833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.23||0.5569|TWO_SIDED|95.0|-4.49|8.29||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.29|-4.49|0.5569
73956086|NCT00991276|147447833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-9.48|STANDARD_ERROR_OF_MEAN|3.2||0.0036|TWO_SIDED|95.0|-15.81|-3.16||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.16|-15.81|0.0036
73956087|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|1.8||0.6947|TWO_SIDED|95.0|-2.85|4.27||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.27|-2.85|0.6947
73956088|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|1.79||0.398|TWO_SIDED|95.0|-5.06|2.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.02|-5.06|0.3980
73956089|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.23|STANDARD_ERROR_OF_MEAN|1.78||0.2144|TWO_SIDED|95.0|-1.3|5.76||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||5.76|-1.30|0.2144
73956090|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|14.17|STANDARD_ERROR_OF_MEAN|4.0||0.0006|TWO_SIDED|95.0|6.25|22.08||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||22.08|6.25|0.0006
73956091|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.07|STANDARD_ERROR_OF_MEAN|3.97||0.0061|TWO_SIDED|95.0|3.22|18.92||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||18.92|3.22|0.0061
73956092|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.95||0.4342|TWO_SIDED|95.0|-4.72|10.93||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||10.93|-4.72|0.4342
73956093|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|2.07||0.242|TWO_SIDED|95.0|-6.53|1.66||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.66|-6.53|0.2420
74039519|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.278|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.22|0.2780
73874515|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072|STANDARD_ERROR_OF_MEAN|0.1125|||TWO_SIDED|95.0|-0.155|0.3|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 minutes|||0.300|-0.155|
73874516|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.051|STANDARD_ERROR_OF_MEAN|0.1303|||TWO_SIDED|95.0|-0.213|0.314|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 minutes|||0.314|-0.213|
73874517|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.142|STANDARD_ERROR_OF_MEAN|0.1572|||TWO_SIDED|95.0|-0.176|0.461|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 15 minutes|||0.461|-0.176|
73874518|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.094|STANDARD_ERROR_OF_MEAN|0.1494|||TWO_SIDED|95.0|-0.208|0.396|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 20 minutes|||0.396|-0.208|
73874519|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.1332|||TWO_SIDED|95.0|-0.212|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 30 minutes|||0.327|-0.212|
73874520|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.065|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|-0.224|0.354|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 45 minutes|||0.354|-0.224|
73874521|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.016|STANDARD_ERROR_OF_MEAN|0.1283|||TWO_SIDED|95.0|-0.276|0.243|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1 hour|||0.243|-0.276|
73874522|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.1118|||TWO_SIDED|95.0|-0.209|0.244|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1.5 hours|||0.244|-0.209|
73874523|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.148|STANDARD_ERROR_OF_MEAN|0.0998|||TWO_SIDED|95.0|-0.35|0.053|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2 hours|||0.053|-0.350|
73874524|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.086|STANDARD_ERROR_OF_MEAN|0.0829|||TWO_SIDED|95.0|-0.253|0.082|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2.5 hours|||0.082|-0.253|
73956094|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|2.05||0.981|TWO_SIDED|95.0|-4.12|4.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.02|-4.12|0.9810
73956095|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|2.05||0.2468|TWO_SIDED|95.0|-6.44|1.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.67|-6.44|0.2468
73956096|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.32||0.1496|TWO_SIDED|95.0|-0.17|1.09||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.09|-0.17|0.1496
73956097|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.31||0.8184|TWO_SIDED|95.0|-0.69|0.55||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.55|-0.69|0.8184
73956098|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.31||0.0918|TWO_SIDED|95.0|-0.09|1.15||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.15|-0.09|0.0918
73956099|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-9.89|STANDARD_ERROR_OF_MEAN|2.48||0.0001|TWO_SIDED|95.0|-14.8|-4.99||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-4.99|-14.80|0.0001
73956100|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.54|STANDARD_ERROR_OF_MEAN|2.46||0.0089|TWO_SIDED|95.0|-11.42|-1.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.67|-11.42|0.0089
73984170|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4238||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4238
73984171|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7714||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.7714
73984172|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8731||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8731
73984173|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8926
73984174|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2072||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.2072
73984175|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.1042
73984176|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2695||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.2695
73984177|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3245||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3245
73984178|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7791||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.7791
73984179|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0999||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.0999
73984180|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9543||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.9543
73984181|NCT00141271|147513578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.3153
73874525|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.0843|||TWO_SIDED|95.0|-0.211|0.13|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3 hours|||0.130|-0.211|
73984182|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2878||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.2878
73984183|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4481||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.4481
73984184|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4099
73984185|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5093||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value.||Week 2||||0.5093
73874526|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.161|0.202|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3.5 hours|||0.202|-0.161|
73984186|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value.||Week 3||||0.8048
73984187|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.0552
73984188|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9795||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.9795
73984189|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5073||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.5073
73874527|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.0947|||TWO_SIDED|95.0|-0.196|0.186|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4 hour|||0.186|-0.196|
73984190|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4882||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.4882
73874528|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.113|STANDARD_ERROR_OF_MEAN|0.1079|||TWO_SIDED|95.0|-0.105|0.33|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4.5 hours|||0.330|-0.105|
73874529|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.0968|||TWO_SIDED|95.0|-0.065|0.326|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 hours|||0.326|-0.065|
73874530|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.007|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|95.0|-0.213|0.199|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5.5 hours|||0.199|-0.213|
73984191|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3967||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3967
73984192|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8276||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8276
73984193|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8502||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8502
73984194|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6343||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.6343
73984195|NCT00141271|147513579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.3082
73984196|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6932||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6932
73984197|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0287
73984198|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2128||95.0||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.2128
73984199|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1118||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.1118
73984200|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.6144
73874531|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.1138|||TWO_SIDED|95.0|-0.052|0.407|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6 hours|||0.407|-0.052|
73874532|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.135|STANDARD_ERROR_OF_MEAN|0.1065|||TWO_SIDED|95.0|-0.08|0.351|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6.5 hours|||0.351|-0.080|
73874533|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.1198|||TWO_SIDED|95.0|-0.062|0.421|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7 hour|||0.421|-0.062|
73874534|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.146|STANDARD_ERROR_OF_MEAN|0.1373|||TWO_SIDED|95.0|-0.131|0.423|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7.5 hours|||0.423|-0.131|
73984201|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.0899
73984202|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8819||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.8819
73984203|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.8374
73984204|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3925||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3925
73984205|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4182||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.4182
73874535|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.1203|||TWO_SIDED|95.0|-0.075|0.411|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8 hours|||0.411|-0.075|
73984206|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8586
73984207|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.549||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.5490
73984208|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6292||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.6292
73984209|NCT00141271|147513580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1473||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.1473
73984210|NCT00141271|147513581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2058||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.2058
73984211|NCT00141271|147513581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9254||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.9254
73984212|NCT00141271|147513581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5071||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.5071
73984213|NCT00141271|147513581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2858||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2858
73984214|NCT00141271|147513581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6298||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6298
73956101|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.35|STANDARD_ERROR_OF_MEAN|2.45||0.1746|TWO_SIDED|95.0|-8.21|1.51||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.51|-8.21|0.1746
74039520|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.433|TWO_SIDED|95.0|-0.21|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.21|0.4330
73874536|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|95.0|-0.047|0.49|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8.5 hours|||0.490|-0.047|
73874537|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.143|STANDARD_ERROR_OF_MEAN|0.1206|||TWO_SIDED|95.0|-0.1|0.387|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9 hours|||0.387|-0.100|
73956102|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.14|STANDARD_ERROR_OF_MEAN|2.44|<|0.0001|TWO_SIDED|95.0|-14.96|-5.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-5.32|-14.96|<0.0001
73984215|NCT00141271|147513581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6034||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6034
73984216|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1454||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.1454
73984217|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2672||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 1||||0.2672
73984218|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2614||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 2||||0.2614
73984219|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.2143
73984220|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.6997
73874538|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.187|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.035|0.41|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9.5 hours|||0.410|-0.035|
73874539|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.1039|||TWO_SIDED|95.0|-0.042|0.378|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 hours|||0.378|-0.042|
73874540|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.221|STANDARD_ERROR_OF_MEAN|0.1036|||TWO_SIDED|95.0|0.011|0.431|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 minutes|||0.431|0.011|
73874541|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.244|STANDARD_ERROR_OF_MEAN|0.1236|||TWO_SIDED|95.0|-0.006|0.494|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 minutes|||0.494|-0.006|
73874542|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.255|STANDARD_ERROR_OF_MEAN|0.1445|||TWO_SIDED|95.0|-0.038|0.548|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 15 minutes|||0.548|-0.038|
73874543|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.233|STANDARD_ERROR_OF_MEAN|0.1436|||TWO_SIDED|95.0|-0.057|0.524|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 20 minutes|||0.524|-0.057|
73874544|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.219|STANDARD_ERROR_OF_MEAN|0.1262|||TWO_SIDED|95.0|-0.036|0.474|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 30 minutes|||0.474|-0.036|
73874545|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.294|STANDARD_ERROR_OF_MEAN|0.1355|||TWO_SIDED|95.0|0.019|0.568|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 45 minutes|||0.568|0.019|
73874546|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.227|STANDARD_ERROR_OF_MEAN|0.1216|||TWO_SIDED|95.0|-0.019|0.473|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1 hour|||0.473|-0.019|
73874547|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1059|||TWO_SIDED|95.0|-0.01|0.418|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1.5 hours|||0.418|-0.010|
73874548|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.0947|||TWO_SIDED|95.0|-0.075|0.308|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2 hours|||0.308|-0.075|
73874549|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.0805|||TWO_SIDED|95.0|-0.136|0.19|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2.5 hours|||0.190|-0.136|
73874550|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.0801|||TWO_SIDED|95.0|-0.116|0.208|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3 hours|||0.208|-0.116|
73874551|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074|STANDARD_ERROR_OF_MEAN|0.0855|||TWO_SIDED|95.0|-0.099|0.247|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3.5 hour|||0.247|-0.099|
73874552|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.051|0.313|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4 hours|||0.313|-0.051|
73956103|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.13|STANDARD_ERROR_OF_MEAN|2.42||0.0359|TWO_SIDED|95.0|-9.91|-0.34||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.34|-9.91|0.0359
73956104|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.01|STANDARD_ERROR_OF_MEAN|2.41||0.0395|TWO_SIDED|95.0|-9.78|-0.24||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.24|-9.78|0.0395
73956105|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0278|TWO_SIDED|95.0|0.02|0.27||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.27|0.02|0.0278
73956106|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.2||95.0|-0.04|0.2||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.20|-0.04|0.2000
73956107|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3396|TWO_SIDED|95.0|-0.06|0.18||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.18|-0.06|0.3396
73956108|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.56|STANDARD_ERROR_OF_MEAN|3.22|<|0.0001|TWO_SIDED|95.0|-20.93|-8.19||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.19|-20.93|<0.0001
73956109|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.11|STANDARD_ERROR_OF_MEAN|3.2||0.0584|TWO_SIDED|95.0|-12.43|0.22||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.22|-12.43|0.0584
73956110|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.45|STANDARD_ERROR_OF_MEAN|3.19||0.009|TWO_SIDED|95.0|-14.76|-2.15||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.15|-14.76|0.0090
73956111|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.69|STANDARD_ERROR_OF_MEAN|2.28||0.2405|TWO_SIDED|95.0|-7.2|1.82||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.82|-7.20|0.2405
73956112|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.26||0.7565|TWO_SIDED|95.0|-5.18|3.77||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.77|-5.18|0.7565
73956113|NCT00991276|147447834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.98|STANDARD_ERROR_OF_MEAN|2.25||0.3792|TWO_SIDED|95.0|-6.43|2.47||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.47|-6.43|0.3792
73956114|NCT00991276|147447835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.27|STANDARD_ERROR_OF_MEAN|1.66||0.0019|TWO_SIDED|95.0|1.98|8.55||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.55|1.98|0.0019
73956115|NCT00991276|147447835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.25|STANDARD_ERROR_OF_MEAN|1.65||0.0506|TWO_SIDED|95.0|-0.01|6.51||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||6.51|-0.01|0.0506
73956116|NCT00991276|147447835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.64||0.2222|TWO_SIDED|95.0|-1.24|5.26||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||5.26|-1.24|0.2222
73956117|NCT01268891|147447836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.35||0.3257|TWO_SIDED|90.0|-0.93|0.23||The threshold for statistical significance in showing a trend for this study is 0.10.|ANCOVA|||The power for this study, which is designed to show a trend, that is, to show a clinical difference in the primary outcome measure, is 72%.||0.23|-0.93|0.3257
73956118|NCT01268891|147447837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0946|TWO_SIDED|95.0|-0.65|0.05|||ANCOVA|||||0.05|-0.65|0.0946
73956119|NCT01268891|147447838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.2258|TWO_SIDED|95.0|-1.84|0.44|||ANCOVA|||||0.44|-1.84|0.2258
73956120|NCT01268891|147447839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.98||0.17|TWO_SIDED|95.0|-3.29|0.59|||ANCOVA|||||0.59|-3.29|0.1700
73956121|NCT00711646|147447842|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.517||||0.048|TWO_SIDED|95.0|-1.029|-0.004|||ANCOVA|||The change in mean 11-point Numerical Rating Scale spasticity score was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline 11-point Numerical Rating Scale spasticity score as a covariate.||-0.004|-1.029|0.048
73956122|NCT00711646|147447843|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.218|TWO_SIDED|95.0|-0.29|0.07|||ANCOVA|||The change in mean Ashworth Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Ashworth Scale score as a covariate.||0.07|-0.29|0.218
73874553|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1025|||TWO_SIDED|95.0|-0.004|0.411|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4.5 hours|||0.411|-0.004|
73984221|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0128||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0128
73984222|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.1144
73984223|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1483||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.1483
73984224|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0674||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0674
73984225|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.2900
74034045|NCT03342469|147620946|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
74034046|NCT03342469|147620946|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)||||>0.05
73874554|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.181|STANDARD_ERROR_OF_MEAN|0.0918|||TWO_SIDED|95.0|-0.004|0.367|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 hours|||0.367|-0.004|
73874555|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.0967|||TWO_SIDED|95.0|-0.018|0.373|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5.5 hours|||0.373|-0.018|
73874556|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.288|STANDARD_ERROR_OF_MEAN|0.1079|||TWO_SIDED|95.0|0.07|0.506|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6 hours|||0.506|0.070|
73984226|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5482||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.5482
73984227|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.0303
73874557|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.283|STANDARD_ERROR_OF_MEAN|0.1011|||TWO_SIDED|95.0|0.079|0.488|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6.5 hours|||0.488|0.079|
73874558|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.386|STANDARD_ERROR_OF_MEAN|0.1137|||TWO_SIDED|95.0|0.157|0.616|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7 hour|||0.616|0.157|
73984228|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6143
73984229|NCT00141271|147513582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3385||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.3385
73984230|NCT00141271|147513583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3299||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3299
74034047|NCT03342469|147620946|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
74039521|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.4946|TWO_SIDED|95.0|-0.2|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.20|0.4946
73874559|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.372|STANDARD_ERROR_OF_MEAN|0.1306|||TWO_SIDED|95.0|0.108|0.636|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7.5 hours|||0.636|0.108|
73874560|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.458|STANDARD_ERROR_OF_MEAN|0.1142|||TWO_SIDED|95.0|0.227|0.688|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8 hours|||0.688|0.227|
73874561|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.509|STANDARD_ERROR_OF_MEAN|0.1264|||TWO_SIDED|95.0|0.254|0.765|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8.5 hours|||0.765|0.254|
73874562|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.492|STANDARD_ERROR_OF_MEAN|0.1144|||TWO_SIDED|95.0|0.261|0.723|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9 hours|||0.723|0.261|
73874563|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.414|STANDARD_ERROR_OF_MEAN|0.1042|||TWO_SIDED|95.0|0.203|0.625|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9.5 hours|||0.625|0.203|
73984231|NCT00141271|147513583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1915||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1915
73984232|NCT00141271|147513584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5407||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5407
73984233|NCT00141271|147513584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6079||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6079
73874564|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.0984|||TWO_SIDED|95.0|0.241|0.639|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 hours|||0.639|0.241|
73874565|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.348|STANDARD_ERROR_OF_MEAN|0.1056|||TWO_SIDED|95.0|0.135|0.562|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 minutes|||0.562|0.135|
73874566|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.494|STANDARD_ERROR_OF_MEAN|0.1273|||TWO_SIDED|95.0|0.237|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 minutes|||0.751|0.237|
73874567|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.499|STANDARD_ERROR_OF_MEAN|0.1484|||TWO_SIDED|95.0|0.199|0.8|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 15 minutes|||0.800|0.199|
73874568|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.573|STANDARD_ERROR_OF_MEAN|0.1481|||TWO_SIDED|95.0|0.274|0.872|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 20 minutes|||0.872|0.274|
73874569|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.488|STANDARD_ERROR_OF_MEAN|0.1303|||TWO_SIDED|95.0|0.225|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 30 minutes|||0.751|0.225|
73984234|NCT00141271|147513585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8464
73984235|NCT00141271|147513585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4023||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.4023
73874570|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.1398|||TWO_SIDED|95.0|0.098|0.663|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 45 minutes|||0.663|0.098|
73874571|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.342|STANDARD_ERROR_OF_MEAN|0.1254|||TWO_SIDED|95.0|0.089|0.596|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1 hour|||0.596|0.089|
73874572|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.218|STANDARD_ERROR_OF_MEAN|0.1094|||TWO_SIDED|95.0|-0.003|0.439|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1.5 hours|||0.439|-0.003|
73874573|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.0974||||95.0|-0.07|0.323|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2 hours|||0.323|-0.070|
73874574|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.0818|||TWO_SIDED|95.0|-0.107|0.223|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2.5 hours|||0.223|-0.107|
73874575|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.0821|||TWO_SIDED|95.0|-0.192|0.139|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3 hours|||0.139|-0.192|
73874576|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.091|STANDARD_ERROR_OF_MEAN|0.0876|||TWO_SIDED|95.0|-0.085|0.268|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3.5 hours|||0.268|-0.085|
73874577|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|95.0|-0.102|0.269|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4 hour|||0.269|-0.102|
73874578|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.249|STANDARD_ERROR_OF_MEAN|0.105|||TWO_SIDED|95.0|0.038|0.461|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4.5 hours|||0.461|0.038|
73874579|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.238|STANDARD_ERROR_OF_MEAN|0.0945|||TWO_SIDED|95.0|0.047|0.429|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 hours|||0.429|0.047|
73984236|NCT00141271|147513585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.287||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2870
73984237|NCT00141271|147513585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2537||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2537
73984238|NCT00141271|147513585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7909||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7909
73984239|NCT00141271|147513585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3308||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3308
73984240|NCT00141271|147513586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3355||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.3355
73984241|NCT00141271|147513586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8447||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8447
73984242|NCT00141271|147513586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8959||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.8959
73984243|NCT00141271|147513586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4826||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.4826
73984244|NCT00141271|147513586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4178||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4178
73984245|NCT00141271|147513586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8277||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.8277
73984246|NCT00141271|147513587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7758||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.7758
73984247|NCT00141271|147513587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8737||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8737
73984248|NCT00141271|147513587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1151||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.1151
73984249|NCT00141271|147513587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.129||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.1290
73984250|NCT00141271|147513587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4432
73984251|NCT00141271|147513587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2988||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2988
73984252|NCT00141271|147513588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8598||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8598
73874580|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.315|STANDARD_ERROR_OF_MEAN|0.0995|||TWO_SIDED|95.0|0.114|0.516|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5.5 hours|||0.516|0.114|
73984253|NCT00141271|147513588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6513||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.6513
73984254|NCT00141271|147513588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6272||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.6272
73984255|NCT00141271|147513588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6467||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.6467
73984256|NCT00141271|147513588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8049||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.8049
73984257|NCT00141271|147513588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9411||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.9411
73984258|NCT00141271|147513589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9260
73984259|NCT00141271|147513589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7100
73984260|NCT00141271|147513590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1836||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1836
73984261|NCT00141271|147513590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1374
73984262|NCT00141271|147513591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9237||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9237
73984263|NCT00141271|147513591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3786||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3786
73984264|NCT00141271|147513592|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4624||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4624
73984265|NCT00141271|147513592|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5971|||||||ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5971
73984266|NCT00141271|147513593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1378||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1378
73984267|NCT00141271|147513593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7665
73984268|NCT00141271|147513594|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4767||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.4767
73984269|NCT00141271|147513594|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2066||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.2066
73984270|NCT00141271|147513595|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1667||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1667
73984271|NCT00141271|147513595|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6727||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6727
73984272|NCT00141271|147513596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7019||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7019
73984273|NCT00141271|147513596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1020
73984274|NCT00141271|147513597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4749||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4749
73984275|NCT00141271|147513597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4491||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4491
74034048|NCT03342469|147620947|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
74034049|NCT03342469|147620947|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
73984276|NCT00141271|147513598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4398||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4398
74034050|NCT03342469|147620947|OTHER|||||||0.04||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1.14)= 4.88, p=0.04||"Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||0.04
74039522|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1884|TWO_SIDED|95.0|-0.25|0.05|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.25|0.1884
73984277|NCT00141271|147513598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3331||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3331
73984278|NCT00141271|147513599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2763||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2763
73984279|NCT00141271|147513599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2048||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2048
73984280|NCT00141271|147513600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4340
73984281|NCT00141271|147513600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7774||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.7774
73984282|NCT00141271|147513601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5195||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.5195
73984283|NCT00141271|147513601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.0153
73984284|NCT00141271|147513602|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2847||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.2847
73984285|NCT00141271|147513602|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1958||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1958
73874581|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.1111|||TWO_SIDED|95.0|0.143|0.591|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6 hours|||0.591|0.143|
73874582|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.361|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|95.0|0.151|0.571|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6.5 hours|||0.571|0.151|
73984286|NCT00141271|147513603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1652||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1652
73874583|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.1168|||TWO_SIDED|95.0|0.131|0.602|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7 hour|||0.602|0.131|
73984287|NCT00141271|147513603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5997
73984288|NCT00141271|147513604|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.0082
74089682|NCT00904748|147732122|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|99.12|||||TWO_SIDED|90.0|92.76|105.93|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||105.93|92.76|
73874584|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.424|STANDARD_ERROR_OF_MEAN|0.1336|||TWO_SIDED|95.0|0.155|0.694|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7.5 hours|||0.694|0.155|
73984289|NCT00141271|147513604|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7037||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7037
73984290|NCT00141271|147513605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2718||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2718
73984291|NCT00141271|147513605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7077||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7077
73984292|NCT00141271|147513606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5057||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5057
73984293|NCT00141271|147513606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3654
73984294|NCT00141271|147513607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6227||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6227
73984295|NCT00141271|147513607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7737||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7737
73984296|NCT02878590|147513646|SUPERIORITY|||||||0.0093|||||||t-test, 2 sided|||||||0.0093
73984297|NCT03322514|147513647|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
73984298|NCT03322514|147513647|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.04
73874585|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.556|STANDARD_ERROR_OF_MEAN|0.1174|||TWO_SIDED|95.0|0.319|0.793|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8 hours|||0.793|0.319|
73874586|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.593|STANDARD_ERROR_OF_MEAN|0.1297||||95.0|0.331|0.854|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8.5 hours|||0.854|0.331|
73984299|NCT03322514|147513647|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.1
73984300|NCT03322514|147513648|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
73984301|NCT03322514|147513648|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.3
73984302|NCT03322514|147513648|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.3
73984303|NCT03322514|147513649|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
74039523|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.521|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.20|0.5210
73984304|NCT03322514|147513649|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.4
73874587|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.559|STANDARD_ERROR_OF_MEAN|0.1177|||TWO_SIDED|95.0|0.322|0.797|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9 hours|||0.797|0.322|
73874588|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.522|STANDARD_ERROR_OF_MEAN|0.1076||||95.0|0.304|0.739|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9.5 hours|||0.739|0.304|
73874589|NCT00857857|147290712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.514|STANDARD_ERROR_OF_MEAN|0.1017||||95.0|0.308|0.719|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 hours|||0.719|0.308|
73874590|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.295|STANDARD_ERROR_OF_MEAN|0.1038||||95.0|0.086|0.503|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 7|||0.503|0.086|
73984305|NCT03322514|147513649|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||baseline to 12 weeks||||0.7
73984306|NCT03451292|147513696|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.17|TWO_SIDED|95.0|0.58|1.1|||Cox Proportional- Hazards (PH) model|||Stratification factors included were the region (Europe or North America) and history of hospitalization for acute decompensation of liver cirrhosis (yes or no).||1.10|0.58|0.17
73984307|NCT05129592|147513710|SUPERIORITY||Mean Difference (Final Values)|15.71|STANDARD_ERROR_OF_MEAN|7.3||0.095|TWO_SIDED|95.0|-1.87|33.3||Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective control and Nicotine corrective with both components of coherence|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective control to the Nicotine corrective with both components of coherence|||33.30|-1.87|0.095
73984308|NCT05129592|147513710|SUPERIORITY||Mean Difference (Final Values)|18.67|STANDARD_ERROR_OF_MEAN|7.3||0.022|TWO_SIDED|95.0|2.02|35.33||Sidak's adjustment for multiple comparisons|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective control to the Nicotine corrective with both components of coherence|Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective with causal explanation and Nicotine corrective with both components of coherence||35.33|2.02|0.022
74034051|NCT03342469|147620947|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
73874591|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.185|STANDARD_ERROR_OF_MEAN|0.0884|||TWO_SIDED|95.0|0.007|0.363|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 13|||0.363|0.007|
73874592|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.144|STANDARD_ERROR_OF_MEAN|0.1026|||TWO_SIDED|95.0|-0.062|0.351|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 14|||0.351|-0.062|
73874593|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.0979|||TWO_SIDED|95.0|0.133|0.527|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 7|||0.527|0.133|
73874594|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.081|STANDARD_ERROR_OF_MEAN|0.0856|||TWO_SIDED|95.0|-0.092|0.253|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 13|||0.253|-0.092|
73874595|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.076|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 14|||0.327|-0.076|
73874596|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.297|STANDARD_ERROR_OF_MEAN|0.0976|||TWO_SIDED|95.0|0.1|0.493|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 7|||0.493|0.100|
73874597|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.256|STANDARD_ERROR_OF_MEAN|0.0859|||TWO_SIDED|95.0|0.083|0.429|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 13|||0.429|0.083|
73874598|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.462|STANDARD_ERROR_OF_MEAN|0.0991|||TWO_SIDED|95.0|0.262|0.662|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 14|||0.662|0.262|
73874599|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.323|STANDARD_ERROR_OF_MEAN|0.0982|||TWO_SIDED|95.0|0.125|0.52|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 7|||0.520|0.125|
73984309|NCT05129592|147513710|SUPERIORITY||Mean Difference (Final Values)|3.69|STANDARD_ERROR_OF_MEAN|7.3||0.931|TWO_SIDED|95.0|-12.76|20.15||Sidak's adjustment for multiple comparisons|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective with reason for misperception to the Nicotine corrective with both components of coherence|Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective with reason for misperception and Nicotine corrective with both components of coherence||20.15|-12.76|0.931
73984310|NCT05129592|147513711|SUPERIORITY||Odds Ratio (OR)|1.54||||0.402|TWO_SIDED|95.0|0.56|4.24|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||4.24|0.56|0.402
73874600|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.229|STANDARD_ERROR_OF_MEAN|0.0858|||TWO_SIDED|95.0|0.057|0.402|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 13|||0.402|0.057|
73874601|NCT00857857|147290714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.372|STANDARD_ERROR_OF_MEAN|0.0991|||TWO_SIDED|95.0|0.172|0.572|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 14|||0.572|0.172|
73874602|NCT00857857|147290724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.482|||TWO_SIDED|95.0|-1.3|0.66|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||0.66|-1.30|
73874603|NCT00857857|147290724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.495|||TWO_SIDED|95.0|-0.73|1.28|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||1.28|-0.73|
73874604|NCT00857857|147290724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|0.36|2.19|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||2.19|0.36|
73984311|NCT05129592|147513711|SUPERIORITY||Odds Ratio (OR)|1.83||||0.292|TWO_SIDED|95.0|0.59|5.62|||Regression, Logistic||Odds of believing e-cigarettes are somewhat or much less harmful than cigarettes in the control condition/odds of believing e-cigarettes are somewhat or much less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||5.62|0.59|0.292
73984312|NCT05129592|147513711|SUPERIORITY||Odds Ratio (OR)|0.77||||0.571|TWO_SIDED|95.0|0.3|1.93|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||1.93|0.30|0.571
73984313|NCT05129592|147513711|SUPERIORITY||Odds Ratio (OR)|1.98|STANDARD_ERROR_OF_MEAN|1.44||0.349|TWO_SIDED|95.0|0.47|8.26|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the control condition/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||8.26|0.47|0.349
73984314|NCT05129592|147513711|SUPERIORITY||Odds Ratio (OR)|1.76|STANDARD_ERROR_OF_MEAN|1.07||0.355|TWO_SIDED|95.0|0.53|5.81|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||5.81|0.53|0.355
73984315|NCT05129592|147513711|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.42||0.591|TWO_SIDED|95.0|0.24|2.25|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||2.25|0.24|0.591
73984316|NCT05129592|147513712|SUPERIORITY|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.99||0.98|TWO_SIDED|95.0|0.13|7.27|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the control condition/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|||7.27|0.13|0.980
74034052|NCT03342469|147620947|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
74034053|NCT03342469|147620947|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
73874605|NCT00857857|147290724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|0.469|||TWO_SIDED|95.0|0.84|2.75|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||2.75|0.84|
74039524|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3329|TWO_SIDED|95.0|-0.23|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.08|-0.23|0.3329
73874606|NCT02709330|147290757|OTHER|||||||0.99|||||||Kolmogorov-Smirnov Test|||Matched historical controls will be identified from the PatientsLikeMe database.||||0.99
73874607|NCT02709330|147290758|OTHER|||||||0.0748|||||||ANOVA|||||||0.0748
73984317|NCT05129592|147513712|SUPERIORITY||Odds Ratio (OR)|0.47|STANDARD_ERROR_OF_MEAN|0.41||0.382|TWO_SIDED|95.0|0.09|2.56|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs||2.56|0.09|0.382
73874608|NCT02709330|147290759|OTHER||||||<|1e-05|||||||Lin's Concordance|||||||<0.00001
73874609|NCT02709330|147290763|OTHER||||||<|1e-05|||||||Lin's Concordance|||||||<0.00001
73984318|NCT05129592|147513712|SUPERIORITY||Odds Ratio, log|0.83|STANDARD_ERROR_OF_MEAN|0.79||0.846|TWO_SIDED|95.0|0.13|5.23|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs||5.23|0.13|0.846
73984319|NCT05129592|147513712|SUPERIORITY||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.05||0.99|TWO_SIDED|95.0|0.13|7.74|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the control condition/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||7.74|0.13|0.990
73984320|NCT05129592|147513712|SUPERIORITY||Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.46||0.458|TWO_SIDED|95.0|0.09|3.01|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||3.01|0.09|0.458
73984321|NCT05129592|147513712|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.7||0.754|TWO_SIDED|95.0|0.12|4.76|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||4.76|0.12|0.754
73984322|NCT05129592|147513713|SUPERIORITY||Odds Ratio, log|1.69|STANDARD_ERROR_OF_MEAN|0.78||0.256|TWO_SIDED|95.0|0.68|4.15|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the control condition/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||4.15|0.68|0.256
74034054|NCT03342469|147620947|OTHER||||||>|0.05|||||||repeated measures General Linear Model|||"Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons"||||>0.05
73984323|NCT05129592|147513713|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.43||0.961|TWO_SIDED|95.0|0.45|2.32|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||2.32|0.45|0.961
73984324|NCT05129592|147513713|SUPERIORITY||Odds Ratio (OR)|0.67|STANDARD_ERROR_OF_MEAN|0.28||0.345|TWO_SIDED|95.0|0.3|1.53|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||1.53|0.30|0.345
73984325|NCT05129592|147513713|SUPERIORITY||Odds Ratio (OR)|1.56|STANDARD_ERROR_OF_MEAN|0.76||0.36|TWO_SIDED|95.0|0.6|4.04|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the control condition/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||4.04|0.60|0.360
73984326|NCT05129592|147513713|SUPERIORITY||Odds Ratio (OR)|1.14|STANDARD_ERROR_OF_MEAN|0.5||0.765|TWO_SIDED|95.0|0.48|2.7|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||2.70|0.48|0.765
73984327|NCT05129592|147513713|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.27||0.252|TWO_SIDED|95.0|0.25|1.43|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||1.43|0.25|0.252
73984328|NCT05129592|147513714|SUPERIORITY||Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.2||0.077|TWO_SIDED|95.0|0.18|1.09|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the control condition/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs||1.09|0.18|0.077
74039525|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5173|TWO_SIDED|95.0|-0.21|0.1|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.21|0.5173
73874610|NCT01279681|147290764|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.93|TWO_SIDED|95.0|0.49|2.17|||Regression, Cox|||||2.17|0.49|0.93
73956123|NCT00711646|147447844|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.17||||0.141|TWO_SIDED|95.0|-0.39|0.06|||ANCOVA|||The change in mean spasm frequency score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline spasm frequency score as a covariate.||0.06|-0.39|0.141
73956124|NCT00711646|147447845|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.3||||0.766|TWO_SIDED|95.0|-7.47|10.07|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.||10.07|-7.47|0.766
73956125|NCT00711646|147447846|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|8.46||||0.349|TWO_SIDED|95.0|-6.74|23.66|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups using Fisher's Exact Test.||23.66|-6.74|0.349
73956126|NCT00711646|147447848|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.86||||0.054|TWO_SIDED|95.0|-0.06|7.78|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.||7.78|-0.06|0.054
73956127|NCT01020838|147447895|SUPERIORITY_OR_OTHER||Sensitivity|0.774|||||TWO_SIDED|95.0|0.654|0.894|||||Point estimate of sensitivity was calculated by the method of Rao and Scott. Variance for sensitivity is based on subjects that contribute at least one brain region, which is amyloid positive according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for sensitivity in beta-amyloid detection based on the majority read.~The following hypothesis was formulated for sensitivity:~H0,sens: sensitivity ≤ 0.6 vs. H1, sens: sensitivity \> 0.6 H0,sens was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.6"||0.894|0.654|
73956128|NCT01020838|147447895|SUPERIORITY_OR_OTHER||Specificity|0.942|||||TWO_SIDED|95.0|0.886|0.998|||||Point estimate of specificity was calculated using the method of Rao and Scott. Variance for specificity is based on subjects that contribute at least one brain region, which is amyloid negative according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for specificity in amyloid detection based on the majority read.~The following hypothesis was formulated for specificity:~H0,spec: specificity ≤ 0.8 vs. H1, spec: specificity \> 0.8 H0,spec was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.8"||0.998|0.886|
73956129|NCT01167426|147447902|SUPERIORITY_OR_OTHER||Difference in mean ranks|79.6|||<|0.0001||95.0|||||Wilcoxon Signed-Rank||Difference in mean ranks between Week 2 and Week 6|Comparison of Week 2 (20 mg/1.0 mL utilizing autoject 2 for glass syringe) to Week 6 (20 mg/0.5 mL utilizing the autoject 2 20 mg/0.5 mL).||||<0.0001
73956130|NCT01167426|147447903|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Goodness-of-fit p-value comparing overall preference to expected frequencies of 33.3% in each category. That is, no preference across the full sample of patients in the study.|Chi-squared|||||||<0.0001
73956131|NCT03102710|147447946|SUPERIORITY|Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for lidocaine before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2.|Mean Difference (Final Values)|0.4||||0.03|TWO_SIDED|||||The threshold for significance was \<0.05.|ANCOVA||The mean difference between anodal vs. sham was 0.4, between cathodal vs. sham was 1.2, and between anodal vs. cathodal was -0.8.|To assess the modulation effects of tDCS on placebo, we first performed an analysis of covariance (ANCOVA) with placebo as the dependent variable and group (i.e., anodal, cathodal, and sham tDCS) as the fixed factor.||||0.03
73956132|NCT03102710|147447946|SUPERIORITY|Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for capsaicin before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2. In addition, we added the STAI state and trait anxiety scores as covariates when assessing the modulation effects of tDCS on the nocebo effect, as previous studies have suggested that anxiety level could affect nocebo hyperalgesia.|Mean Difference (Final Values)|1.3||||0.04|TWO_SIDED|||||The threshold for significance was \<0.05.|ANCOVA||The mean difference between anodal vs. sham was 1.4, between cathodal vs. sham was 1.0, and between anodal vs. cathodal was -0.3.|To assess the modulation effects of tDCS on nocebo, we first performed an analysis of covariance (ANCOVA) with nocebo as the dependent variable and group (i.e., anodal, cathodal, and sham tDCS) as the fixed factor.||||0.04
73956133|NCT03055767|147447967|SUPERIORITY|||||||0.038|||||||Wilcoxon signed-rank test|||||||0.038
73956134|NCT03055767|147447968|SUPERIORITY|||||||0.047|||||||Wilcoxon signed-rank test)|||||||0.047
73956135|NCT03055767|147447969|SUPERIORITY|||||||0.148|||||||Wilcoxon signed-rank test)|||||||0.148
73956136|NCT03055767|147447970|SUPERIORITY|||||||0.047|||||||Wilcoxon signed-rank test)|||||||0.047
73956137|NCT03055767|147447971|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test)|||||||0.002
73956138|NCT03055767|147447972|SUPERIORITY|||||||0.82|||||||McNemar|||||||0.82
73956139|NCT03055767|147447973|SUPERIORITY|||||||0.006|||||||McNemar|||||||0.006
73956140|NCT03055767|147447974|SUPERIORITY|||||||0.039|||||||McNemar|||||||0.039
73956141|NCT03055767|147447975|SUPERIORITY|||||||0.016|||||||McNemar|||||||0.016
73956142|NCT03055767|147447976|SUPERIORITY|||||||0.18|||||||McNemar|||||||0.18
73956143|NCT03055767|147447977|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed-rank test)|||||||<0.001
73956144|NCT03055767|147447978|SUPERIORITY|||||||0.64|||||||Wilcoxon signed-rank test)|||||||0.64
73956145|NCT02219490|147447989|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
73984329|NCT05129592|147513714|SUPERIORITY||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.4||0.853|TWO_SIDED|95.0|0.4|2.15|||Regression, Logistic|||Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs|Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|2.15|0.40|0.853
73984330|NCT05129592|147513714|SUPERIORITY||Odds Ratio, log|0.41|STANDARD_ERROR_OF_MEAN|0.18||0.037|TWO_SIDED|95.0|0.18|0.95|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with both components of coherence/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs||0.95|0.18|0.037
73984331|NCT05129592|147513714|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.33||0.349|TWO_SIDED|95.0|0.21|1.75|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the control condition/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||1.75|0.21|0.349
73984332|NCT05129592|147513714|SUPERIORITY||Odds Ratio (OR)|1.45|STANDARD_ERROR_OF_MEAN|0.74||0.464|TWO_SIDED|95.0|0.54|3.93|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||3.93|0.54|0.464
73984333|NCT05129592|147513714|SUPERIORITY||Odds Ratio (OR)|0.5|STANDARD_ERROR_OF_MEAN|0.26||0.187|TWO_SIDED|95.0|0.18|1.4|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||1.40|0.18|0.187
73984334|NCT05129592|147513715|SUPERIORITY||Odds Ratio (OR)|1.06|STANDARD_ERROR_OF_MEAN|0.66||0.925|TWO_SIDED|95.0|0.31|3.62|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the control condition/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||3.62|0.31|0.925
73984335|NCT05129592|147513715|SUPERIORITY||Odds Ratio (OR)|0.66|STANDARD_ERROR_OF_MEAN|0.43||0.525|TWO_SIDED|95.0|0.19|2.35|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||2.35|0.19|0.525
73984336|NCT05129592|147513715|SUPERIORITY||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.44||0.586|TWO_SIDED|95.0|0.21|2.4|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||2.40|0.21|0.586
73984337|NCT05129592|147513715|SUPERIORITY||Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.71||0.883|TWO_SIDED|95.0|0.31|3.9|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the control condition/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||3.90|0.31|0.883
73984338|NCT05129592|147513715|SUPERIORITY||Odds Ratio (OR)|0.66|STANDARD_ERROR_OF_MEAN|0.44||0.534|TWO_SIDED|95.0|0.18|2.41|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||2.41|0.18|0.534
74034055|NCT03342469|147620947|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
73874611|NCT03678311|147290773|OTHER|The correlation between the outcome and AHI was tested by Spearman's correlation.|Spearman's correlation|0.13||||0.73|TWO_SIDED|95.0|-0.75|1.0|||Spearman's correlation|||Spearman's correlation was used to evaluate the relationship between the outcome and the apnea hypopnea index.||1.00|-0.75|0.73
73984339|NCT05129592|147513715|SUPERIORITY||Odds Ratio (OR)|0.76|STANDARD_ERROR_OF_MEAN|0.48||0.661|TWO_SIDED|95.0|0.22|2.62|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||2.62|0.22|0.661
73984340|NCT05129592|147513716|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|4.66||0.965|TWO_SIDED|95.0|-9.25|13.19|||ANCOVA|Sidak's adjusted p-value (df=4)|Nicotine corrective control - Nicotine corrective with both components of coherence|ANCOVA adjusted for baseline consideration of switching||13.19|-9.25|0.965
73984341|NCT05129592|147513716|SUPERIORITY||Mean Difference (Final Values)|1.57|STANDARD_ERROR_OF_MEAN|4.44||0.979|TWO_SIDED|95.0|-9.13|12.27|||ANCOVA|Sidak's adjusted p-value (df=4)||ANCOVA adjusted for baseline consideration of switching|Nicotine corrective with causal explanation - Nicotine corrective with both components of coherence|12.27|-9.13|0.979
73984342|NCT05129592|147513716|SUPERIORITY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|4.37||0.73|TWO_SIDED|95.0|-6.46|14.59|||ANCOVA|Sidak's adjusted p-value (df=4)||ANCOVA adjusted for baseline consideration of switching|Nicotine corrective with reason for misperception - Nicotine corrective with both components of coherence|14.59|-6.46|0.73
73984343|NCT01090076|147513717|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||t-test, 2 sided|||||||0.023
73984344|NCT01090076|147513718|SUPERIORITY_OR_OTHER|||||||0.877||95.0|||||t-test, 2 sided|||||||0.877
73984345|NCT01090076|147513719|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
73984346|NCT01636258|147513720|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|2.1||0.72|TWO_SIDED|95.0|-1.4|2.0||P-value less than 0.05 considered statistically significant a priori. No multiple comparison adjustment made.|t-test, 2 sided|||No sample size calculation performed since it was a pilot study. Null hypothesis was no difference between groups.||2.0|-1.4|0.72
73984347|NCT01636258|147513721|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||No sample study calculation performed since it was a pilot study. Null hypothesis was no difference between groups.||||0.31
73984348|NCT01636258|147513722|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
73984349|NCT01636258|147513723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
73984350|NCT01763346|147513725|SUPERIORITY|||||||0.05||||||35 subjects per group provided 80% power to detect an effect size of 0.59, assuming a 2-sided p=0.05, adjustment for baseline measures using ANCOVA, and correlation of 0.5 between baseline and end-study measures.|General Linear Models|Differences in primary outcomes between groups at 24-months were compared using general linear models with baseline values included as covariates.||We selected a sample size that would allow detection of an effect size of \~0.6 or greater between gastric band and metformin groups for measures of β-cell function after two years, hypothesizing greater function in the gastric band group.||||0.05
73984351|NCT00116584|147513728|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
73984352|NCT00116584|147513729|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73984353|NCT00116584|147513730|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74089683|NCT00904748|147732122|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.84|||||TWO_SIDED|90.0|91.56|104.56|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||104.56|91.56|
73984354|NCT02592434|147513761|SUPERIORITY||Difference in percentage|-23.69||||0.0031|TWO_SIDED|95.0|-39.41|-7.97||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||-7.97|-39.41|0.0031
73984355|NCT02592434|147513762|SUPERIORITY||Difference in percentage|19.52||||0.0166|TWO_SIDED|95.0|3.55|35.5||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||35.50|3.55|0.0166
73984356|NCT02592434|147513763|SUPERIORITY||Difference in percentage|23.69||||0.0031|TWO_SIDED|95.0|7.97|39.41||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||39.41|7.97|0.0031
73984357|NCT02592434|147513764|SUPERIORITY||Difference in percentage|17.02||||0.0387|TWO_SIDED|95.0|0.88|33.17||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||33.17|0.88|0.0387
73984358|NCT02592434|147513765|SUPERIORITY||Ls mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0292|TWO_SIDED|95.0|-0.22|-0.01||Threshold for significance at 0.05 level.|Mixed Model for Repeated Measures (MMRM)|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance. Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-0.01|-0.22|0.0292
73984359|NCT02592434|147513767|SUPERIORITY||Difference in percentage|-1.71||||0.741|TWO_SIDED|95.0|-11.82|8.41|||Normal approximation to the binomial|||at Week 20||8.41|-11.82|0.7410
73984360|NCT02592434|147513767|SUPERIORITY||Difference in percentage|-18.93||||0.0052|TWO_SIDED|95.0|-32.22|-5.64|||Normal approximation to the binomial|||at Week 24||-5.64|-32.22|0.0052
73984361|NCT02592434|147513767|SUPERIORITY||Difference in percentage|-19.09||||0.0093|TWO_SIDED|95.0|-33.48|-4.7|||Normal approximation to the binomial|||at Week 28||-4.70|-33.48|0.0093
73874612|NCT01454791|147290800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
73874613|NCT01454791|147290801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.6059|TWO_SIDED||||||t-test, 2 sided||not significant|||||0.6059
73874614|NCT01454791|147290802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.705|TWO_SIDED||||||t-test, 2 sided||not significant|||||0.705
73984362|NCT02592434|147513767|SUPERIORITY||Difference in percentage|-22.1||||0.0045|TWO_SIDED|95.0|-37.35|-6.86|||Normal approximation to the binomial|||at Week 32||-6.86|-37.35|0.0045
73874615|NCT00181363|147290821|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73984363|NCT02592434|147513767|SUPERIORITY||Difference in percentage|-23.57||||0.0027|TWO_SIDED|95.0|-38.97|-8.17|||Normal approximation to the binomial|||at Week 36||-8.17|-38.97|0.0027
73984364|NCT02592434|147513767|SUPERIORITY||Difference in percentage|-25.08||||0.0016|TWO_SIDED|95.0|-40.69|-9.47|||Normal approximation to the binomial|||at Week 40||-9.47|-40.69|0.0016
73984365|NCT02592434|147513771|SUPERIORITY||Difference in percentage|6.03||||0.301|TWO_SIDED|95.0|-5.4|17.46|||Normal approximation to the binomial|||at Week 20||17.46|-5.40|0.3010
73984366|NCT02592434|147513771|SUPERIORITY||Difference in percentage|17.54||||0.0108|TWO_SIDED|95.0|4.05|31.03|||Normal approximation to the binomial|||at Week 24||31.03|4.05|0.0108
73984367|NCT02592434|147513771|SUPERIORITY||Difference in percentage|19.13||||0.0103|TWO_SIDED|95.0|4.51|33.74|||Normal approximation to the binomial|||at Week 28||33.74|4.51|0.0103
73874616|NCT00181363|147290822|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73874617|NCT00181363|147290823|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73874618|NCT00181363|147290824|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73874619|NCT00181363|147290825|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73874620|NCT00669214|147290845|SUPERIORITY_OR_OTHER||Difference in proportion|0.163||||0.1054||95.0|-0.063|0.393|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.393|-0.063|0.1054
73874621|NCT00669214|147290847|SUPERIORITY_OR_OTHER||Difference in proportion|0.155||||0.2404||95.0|-0.072|0.388|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.388|-0.072|0.2404
73874622|NCT00669214|147290849|SUPERIORITY_OR_OTHER||Difference in proportion|0.228||||0.0366||95.0|0.003|0.452|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.452|0.003|0.0366
73874623|NCT00669214|147290851|SUPERIORITY_OR_OTHER||Difference in mean change from Day 0|3.33||||0.1816||95.0|-2.811|9.471|||Student T-test|||||9.471|-2.811|0.1816
73874624|NCT00669214|147290853|SUPERIORITY_OR_OTHER||Difference in mean change from Day 0|1.19||||0.0435||95.0|-0.161|2.532|||Student T-test|||||2.532|-0.161|0.0435
73874625|NCT00669214|147290855|SUPERIORITY_OR_OTHER|||||||0.0224||95.0|||||Wilcoxon rank sum|||||||0.0224
74039526|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.2346|TWO_SIDED|95.0|-0.25|0.06|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.25|0.2346
73874626|NCT00997035|147290871|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.29|TWO_SIDED|95.0|0.57|1.18|||Regression, Cox|Cox proportional hazards regression to estimate the hazard of perforation or need for TPK.||The sample size was determined based on the primary end point: perforation or the need for TPK within 3 months. Simulation-based analyses estimated that a sample sizeof 240 study participants (120 per arm) would provide 80% power to detect a 15% difference in the 3-month perforation or need for TPK rate between topical antifungal plus oral voriconazole vs topical antifungal alone,with a 2-tailed α value of .05 and approximately 15%loss to follow-up.||1.18|0.57|0.29
73874627|NCT00997035|147290876|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.65|TWO_SIDED|95.0|0.49|1.57|||Regression, Cox|||||1.57|.49|0.65
73874628|NCT00997035|147290878|SUPERIORITY||||||<|0.001||||||Statistically significant after Holms-Šidák correction for multiple comparisons.|Fisher Exact|||||||<0.001
73874629|NCT01072188|147290923|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73874630|NCT01072188|147290924|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73874631|NCT04640311|147290943|OTHER||Geometric mean ratio|1.028|||||TWO_SIDED|90.0|0.9699|1.09|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.|||1.090|0.9699|
73874632|NCT04640311|147290943|OTHER||Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.9602|1.081|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.|||1.081|0.9602|
73984368|NCT02592434|147513771|SUPERIORITY||Difference in percentage|23.53||||0.0025|TWO_SIDED|95.0|8.27|38.8|||Normal approximation to the binomial|||at Week 32||38.80|8.27|0.0025
73984369|NCT02592434|147513771|SUPERIORITY||Difference in percentage|25.04||||0.0016|TWO_SIDED|95.0|9.52|40.56|||Normal approximation to the binomial|||at Week 36||40.56|9.52|0.0016
73984370|NCT02592434|147513771|SUPERIORITY||Difference in percentage|23.69||||0.0031|TWO_SIDED|95.0|7.97|39.41|||Normal approximation to the binomial|||at Week 40||39.41|7.97|0.0031
73984371|NCT02592434|147513773|SUPERIORITY||Difference in percentage|-1.15||||0.8119|TWO_SIDED|95.0|-10.63|8.33|||Normal approximation for binomial|||Double Blind Baseline (Week 18)||8.33|-10.63|0.8119
73984372|NCT02592434|147513773|SUPERIORITY||Difference in percentage|7.66||||0.2682|TWO_SIDED|95.0|-5.9|21.21|||Normal approximation for binomial|||Week 20||21.21|-5.90|0.2682
73984373|NCT02592434|147513773|SUPERIORITY||Difference in percentage|21.98||||0.0034|TWO_SIDED|95.0|7.26|36.71|||Normal approximation for binomial|||Week 24||36.71|7.26|0.0034
73984374|NCT02592434|147513773|SUPERIORITY||Difference in percentage|17.9||||0.0233|TWO_SIDED|95.0|2.44|33.36|||Normal approximation for binomial|||Week 28||33.36|2.44|0.0233
73984375|NCT02592434|147513773|SUPERIORITY||Difference in percentage|25.16||||0.0018|TWO_SIDED|95.0|9.39|40.93|||Normal approximation for binomial|||Week 32||40.93|9.39|0.0018
73984376|NCT02592434|147513773|SUPERIORITY||Difference in percentage|20.91||||0.0099|TWO_SIDED|95.0|5.01|36.81|||Normal approximation for binomial|||Week 36||36.81|5.01|0.0099
73984377|NCT02592434|147513773|SUPERIORITY||Difference in percentage|22.34||||0.0058|TWO_SIDED|95.0|6.46|38.22|||Normal approximation for binomial|||Week 40||38.22|6.46|0.0058
73984378|NCT02592434|147513775|SUPERIORITY||Difference in percentage|3.77||||0.6348|TWO_SIDED|95.0|-11.79|19.33|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||19.33|-11.79|0.6348
73984379|NCT02592434|147513775|SUPERIORITY||Difference in percentage|2.62||||0.7525|TWO_SIDED|95.0|-13.66|18.9|||Normal approximation to the binomial|||Week 20||18.90|-13.66|0.7525
73984380|NCT02592434|147513775|SUPERIORITY||Difference in percentage|14.05||||0.0908|TWO_SIDED|95.0|-2.23|30.33|||Normal approximation to the binomial|||Week 24||30.33|-2.23|0.0908
73984381|NCT02592434|147513775|SUPERIORITY||Difference in percentage|7.02||||0.4026|TWO_SIDED|95.0|-9.38|23.43|||Normal approximation to the binomial|||Week 28||23.43|-9.38|0.4026
73984382|NCT02592434|147513775|SUPERIORITY||Difference in percentage|18.37||||0.0258|TWO_SIDED|95.0|2.22|34.52|||Normal approximation to the binomial|||Week 32||34.52|2.22|0.0258
73984383|NCT02592434|147513775|SUPERIORITY||Difference in percentage|19.88||||0.0149|TWO_SIDED|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 36||35.88|3.88|0.0149
73984384|NCT02592434|147513775|SUPERIORITY||Difference in percentage|19.88||||0.0149|TWO_SIDED|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 40||35.88|3.88|0.0149
73984385|NCT02592434|147513777|SUPERIORITY||Difference in percentage|-5.24||||0.515|TWO_SIDED|95.0|-21.0|10.53|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||10.53|-21.00|0.5150
73984386|NCT02592434|147513777|SUPERIORITY||Difference in percentage|9.01||||0.24||95.0|-6.02|24.03|||Normal approximation to the binomial|||Week 20||24.03|-6.02|0.2400
73984387|NCT02592434|147513777|SUPERIORITY||Difference in percentage|8.93||||0.2557|TWO_SIDED|95.0|-6.47|24.33|||Normal approximation to the binomial|||Week 24||24.33|-6.47|0.2557
73984388|NCT02592434|147513777|SUPERIORITY||Difference in percentage|8.97||||0.2481|TWO_SIDED|95.0|-6.25|24.19|||Normal approximation to the binomial|||Week 28||24.19|-6.25|0.2481
73984389|NCT02592434|147513777|SUPERIORITY||Difference in percentage|16.03||||0.0356|TWO_SIDED|95.0|1.08|30.98|||Normal approximation to the binomial|||Week 32||30.98|1.08|0.0356
73984390|NCT02592434|147513777|SUPERIORITY||Difference in percentage|18.89||||0.0115|TWO_SIDED|95.0|4.24|33.54|||Normal approximation to the binomial|||Week 36||33.54|4.24|0.0115
74034056|NCT03342469|147620947|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
74039527|NCT02528253|147632447|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.3634|TWO_SIDED|95.0|-0.23|0.09|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.23|0.3634
73984391|NCT02592434|147513777|SUPERIORITY||Difference in percentage|11.87||||0.115|TWO_SIDED|95.0|-2.89|26.62|||Normal approximation to the binomial|||Week 40||26.62|-2.89|0.1150
73984392|NCT02592434|147513777|SUPERIORITY||Difference in percentage|13.29||||0.0744|TWO_SIDED|95.0|-1.31|27.9|||Normal approximation to the binomial|||Week 44||27.90|-1.31|0.0744
73984393|NCT02592434|147513779|SUPERIORITY||Difference in percentage|-16.15||||0.0207|TWO_SIDED|95.0|-29.84|-2.46|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||-2.46|-29.84|0.0207
73984394|NCT02592434|147513779|SUPERIORITY||Difference in percentage|10.63||||0.1254|TWO_SIDED|95.0|-2.97|24.24|||Normal approximation to the binomial|||Week 20||24.24|-2.97|0.1254
73984395|NCT02592434|147513779|SUPERIORITY||Difference in percentage|3.49||||0.635|TWO_SIDED|95.0|-10.93|17.91|||Normal approximation to the binomial|||Week 24||17.91|-10.93|0.6350
73984396|NCT02592434|147513779|SUPERIORITY||Difference in percentage|2.1||||0.7732|TWO_SIDED|95.0|-12.2|16.41|||Normal approximation to the binomial|||Week 28||16.41|-12.20|0.7732
73984397|NCT02592434|147513779|SUPERIORITY||Difference in percentage|6.35||||0.3782|TWO_SIDED|95.0|-7.77|20.47|||Normal approximation to the binomial|||Week 32||20.47|-7.77|0.3782
73984398|NCT02592434|147513779|SUPERIORITY||Difference in percentage|11.98||||0.0936|TWO_SIDED|95.0|-2.02|25.99|||Normal approximation to the binomial|||Week 36||25.99|-2.02|0.0936
73984399|NCT02592434|147513779|SUPERIORITY||Difference in percentage|9.17||||0.2017|TWO_SIDED|95.0|-4.91|23.24|||Normal approximation to the binomial|||Week 40||23.24|-4.91|0.2017
73984400|NCT02592434|147513779|SUPERIORITY||Difference in percentage|12.02||||0.0858|TWO_SIDED|95.0|-1.69|25.74|||Normal approximation to the binomial|||Week 44||25.74|-1.69|0.0858
73984401|NCT02592434|147513781|SUPERIORITY||LS mean difference|-2.07|STANDARD_ERROR_OF_MEAN|0.78||0.0088|TWO_SIDED|95.0|-3.6|-0.53|||MMRM|||Week 20; Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.53|-3.60|0.0088
73984402|NCT02592434|147513781|SUPERIORITY||LS mean difference|-3.64|STANDARD_ERROR_OF_MEAN|1.28||0.0054|TWO_SIDED|95.0|-6.17|-1.1|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.10|-6.17|0.0054
73984403|NCT02592434|147513781|SUPERIORITY||LS mean difference|-3.85|STANDARD_ERROR_OF_MEAN|1.25||0.0039|TWO_SIDED|95.0|-6.38|-1.32|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.32|-6.38|0.0039
73984404|NCT02592434|147513781|SUPERIORITY||LS mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.98||0.0022|TWO_SIDED|95.0|-5.3|-1.29|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.29|-5.30|0.0022
73984405|NCT02592434|147513781|SUPERIORITY||LS mean difference|-6.21|STANDARD_ERROR_OF_MEAN|1.57||0.0005|TWO_SIDED|95.0|-9.42|-3.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-3.00|-9.42|0.0005
73984406|NCT02592434|147513781|SUPERIORITY||LS mean difference|-6.26|STANDARD_ERROR_OF_MEAN|1.63||0.0006|TWO_SIDED|95.0|-9.6|-2.92|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-2.92|-9.60|0.0006
73984407|NCT02592434|147513781|SUPERIORITY||LS mean difference|-4.36|STANDARD_ERROR_OF_MEAN|1.27||0.0027|TWO_SIDED|95.0|-7.02|-1.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.71|-7.02|0.0027
73984408|NCT02592434|147513783|SUPERIORITY||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.76||0.0172|TWO_SIDED|95.0|-3.32|-0.33|||MMRM|||Week 20: Analysis was based on Mixed Model for Repeated Measures (MMRM) with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-0.33|-3.32|0.0172
73984409|NCT02592434|147513783|SUPERIORITY||LS Mean Difference|-3.41|STANDARD_ERROR_OF_MEAN|1.21||0.0057|TWO_SIDED|95.0|-5.81|-1.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.01|-5.81|0.0057
73984410|NCT02592434|147513783|SUPERIORITY||LS Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|1.16||0.0038|TWO_SIDED|95.0|-5.94|-1.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.23|-5.94|0.0038
73984411|NCT02592434|147513783|SUPERIORITY||LS Mean Difference|-3.41|STANDARD_ERROR_OF_MEAN|1.01||0.002|TWO_SIDED|95.0|-5.47|-1.36|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.36|-5.47|0.0020
73984412|NCT02592434|147513783|SUPERIORITY||LS Mean Difference|-5.66|STANDARD_ERROR_OF_MEAN|1.52||0.0007|TWO_SIDED|95.0|-8.74|-2.57|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.57|-8.74|0.0007
73984413|NCT02592434|147513783|SUPERIORITY||LS Mean Difference|-5.62|STANDARD_ERROR_OF_MEAN|1.49||0.0007|TWO_SIDED|95.0|-8.66|-2.58|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.58|-8.66|0.0007
73984414|NCT02592434|147513783|SUPERIORITY||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|1.25||0.0018|TWO_SIDED|95.0|-6.99|-1.82|||MMRM|||Week 44:Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.82|-6.99|0.0018
73984415|NCT02592434|147513785|SUPERIORITY||Difference in percentage|1.47||||0.861|TWO_SIDED|95.0|-14.96|17.9|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||17.90|-14.96|0.8610
73984416|NCT02592434|147513785|SUPERIORITY||Difference in percentage|10.12||||0.2173|TWO_SIDED|95.0|-5.96|26.2|||Normal approximation to the binomial|||Week 20||26.20|-5.96|0.2173
73984417|NCT02592434|147513785|SUPERIORITY||Difference in percentage|12.94||||0.1135|TWO_SIDED|95.0|-3.08|28.96|||Normal approximation to the binomial|||Week 24||28.96|-3.08|0.1135
73984418|NCT02592434|147513785|SUPERIORITY||Difference in percentage|11.51||||0.161|TWO_SIDED|95.0|-4.58|27.6|||Normal approximation to the binomial|||Week 28||27.60|-4.58|0.1610
73984419|NCT02592434|147513785|SUPERIORITY||Difference in percentage|7.42||||0.3571|TWO_SIDED|95.0|-8.37|23.21|||Normal approximation to the binomial|||Week 32||23.21|-8.37|0.3571
73984420|NCT02592434|147513785|SUPERIORITY||Difference in percentage|14.44||||0.0716|TWO_SIDED|95.0|-1.27|30.16|||Normal approximation to the binomial|||Week 36||30.16|-1.27|0.0716
73984421|NCT02592434|147513785|SUPERIORITY||Difference in percentage|14.4||||0.0746|TWO_SIDED|95.0|-1.43|30.24|||Normal approximation to the binomial|||Week 40||30.24|-1.43|0.0746
73984422|NCT02592434|147513785|SUPERIORITY||Difference in percentage|14.37||||0.0773|TWO_SIDED|95.0|-1.57|30.3|||Normal approximation to the binomial|||Week 44||30.30|-1.57|0.0773
73984423|NCT02592434|147513787|SUPERIORITY||Difference in percentage|-3.06||||0.5131|TWO_SIDED|95.0|-12.21|6.1|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||6.10|-12.21|0.5131
73984424|NCT02592434|147513787|SUPERIORITY||Difference in percentage|6.87||||0.0876|TWO_SIDED|95.0|-1.01|14.74|||Normal approximation to the binomial|||Week 20||14.74|-1.01|0.0876
73984425|NCT02592434|147513787|SUPERIORITY||Difference in percentage|6.79||||0.1561|TWO_SIDED|95.0|-2.59|16.16|||Normal approximation to the binomial|||Week 24||16.16|-2.59|0.1561
73984426|NCT02592434|147513787|SUPERIORITY||Difference in percentage|2.58||||0.5795|TWO_SIDED|95.0|-6.54|11.7|||Normal approximation to the binomial|||Week 28||11.70|-6.54|0.5795
73984427|NCT02592434|147513787|SUPERIORITY||Difference in percentage|5.4||||0.2435|TWO_SIDED|95.0|-3.67|14.47|||Normal approximation to the binomial|||Week 32||14.47|-3.67|0.2435
73984428|NCT02592434|147513787|SUPERIORITY||Difference in percentage|9.52||||0.0758|TWO_SIDED|95.0|-0.99|20.04|||Normal approximation to the binomial|||Week 36||20.04|-0.99|0.0758
73984429|NCT02592434|147513787|SUPERIORITY||Difference in percentage|10.91||||0.0464|TWO_SIDED|95.0|0.17|21.65|||Normal approximation to the binomial|||Week 40||21.65|0.17|0.0464
73984430|NCT02592434|147513787|SUPERIORITY||Difference in percentage|8.06||||0.1634|TWO_SIDED|95.0|-3.27|19.38|||Normal approximation to the binomial|||Week 44||19.38|-3.27|0.1634
73984431|NCT02592434|147513788|SUPERIORITY||Difference in percentage|-17.42||||0.0062|TWO_SIDED|95.0|-29.88|-4.96|||Normal approximation to the binomial|||Double Blind baseline (Week 18)||-4.96|-29.88|0.0062
73984432|NCT02592434|147513788|SUPERIORITY||Difference in percentage|-0.44||||0.9427|TWO_SIDED|95.0|-12.34|11.47|||Normal approximation to the binomial|||Week 20||11.47|-12.34|0.9427
73984433|NCT02592434|147513788|SUPERIORITY||Difference in percentage|-0.6||||0.9308|TWO_SIDED|95.0|-14.03|12.84|||Normal approximation to the binomial|||Week 24||12.84|-14.03|0.9308
73984434|NCT02592434|147513788|SUPERIORITY||Difference in percentage|0.87||||0.8945|TWO_SIDED|95.0|-12.03|13.78|||Normal approximation to the binomial|||Week 28||13.78|-12.03|0.8945
73984435|NCT02592434|147513788|SUPERIORITY||Difference in percentage|2.22||||0.7455|TWO_SIDED|95.0|-11.2|15.64|||Normal approximation to the binomial|||Week 32||15.64|-11.20|0.7455
73984436|NCT02592434|147513788|SUPERIORITY||Difference in percentage|9.25||||0.1787|TWO_SIDED|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 36||22.72|-4.23|0.1787
73984437|NCT02592434|147513788|SUPERIORITY||Difference in percentage|12.1||||0.0695|TWO_SIDED|95.0|-0.97|25.17|||Normal approximation to the binomial|||Week 40||25.17|-0.97|0.0695
73984438|NCT02592434|147513788|SUPERIORITY||Difference in percentage|9.25||||0.1787|TWO_SIDED|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 44||22.72|-4.23|0.1787
73984439|NCT02592434|147513789|SUPERIORITY||Difference in percentage|-0.12||||0.9719|TWO_SIDED|95.0|-6.74|6.5|||Normal approximation to the binomial|||||6.50|-6.74|0.9719
73984440|NCT02592434|147513791|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.61||0.1595|TWO_SIDED|95.0|-2.08|0.35|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.35|-2.08|0.1595
73984441|NCT02592434|147513791|SUPERIORITY||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.96||0.1421|TWO_SIDED|95.0|-3.32|0.48|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.48|-3.32|0.1421
73984442|NCT02592434|147513791|SUPERIORITY||LS Mean difference|-1.66|STANDARD_ERROR_OF_MEAN|0.83||0.0552|TWO_SIDED|95.0|-3.37|0.04|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.04|-3.37|0.0552
73984443|NCT02592434|147513791|SUPERIORITY||LS Mean difference|-1.17|STANDARD_ERROR_OF_MEAN|0.63||0.0822|TWO_SIDED|95.0|-2.5|0.17|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.17|-2.50|0.0822
73984444|NCT02592434|147513791|SUPERIORITY||LS Mean difference|-3.98|STANDARD_ERROR_OF_MEAN|1.22||0.0041|TWO_SIDED|95.0|-6.53|-1.43|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.43|-6.53|0.0041
73984445|NCT02592434|147513791|SUPERIORITY||LS Mean difference|-3.57|STANDARD_ERROR_OF_MEAN|1.22||0.0085|TWO_SIDED|95.0|-6.12|-1.02|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.02|-6.12|0.0085
73984446|NCT02592434|147513791|SUPERIORITY||LS Mean difference|-2.24|STANDARD_ERROR_OF_MEAN|1.03||0.0384|TWO_SIDED|95.0|-4.36|-0.13|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.13|-4.36|0.0384
73984447|NCT02592434|147513793|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.23||0.2595|TWO_SIDED|95.0|-0.72|0.19|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.19|-0.72|0.2595
74034057|NCT03342469|147620947|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
74039528|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0007|TWO_SIDED|95.0|1.26|2.39|||Regression, Logistic|||Week 2, \>=30%: Odds ratio (OR) and 95% Confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.26|0.0007
73984448|NCT02592434|147513793|SUPERIORITY||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.0674|TWO_SIDED|95.0|-1.42|0.05|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.05|-1.42|0.0674
73984449|NCT02592434|147513793|SUPERIORITY||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.49||0.058|TWO_SIDED|95.0|-1.93|0.03|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.03|-1.93|0.0580
73984450|NCT02592434|147513793|SUPERIORITY||LS Mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.44||0.0751|TWO_SIDED|95.0|-1.67|0.08|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.08|-1.67|0.0751
73984451|NCT02592434|147513793|SUPERIORITY||LS Mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.43||0.0251|TWO_SIDED|95.0|-1.88|-0.13|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.13|-1.88|0.0251
73984452|NCT02592434|147513793|SUPERIORITY||LS Mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.49||0.0331|TWO_SIDED|95.0|-2.07|-0.09|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.09|-2.07|0.0331
73984453|NCT02592434|147513793|SUPERIORITY||LS Mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.42||0.0549|TWO_SIDED|95.0|-1.66|0.02|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.02|-1.66|0.0549
73984454|NCT02592434|147513795|SUPERIORITY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.25||0.0353|TWO_SIDED|95.0|-1.04|-0.04|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.04|-1.04|0.0353
73984455|NCT02592434|147513795|SUPERIORITY||LS Mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.32||0.0094|TWO_SIDED|95.0|-1.47|-0.21|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.21|-1.47|0.0094
73874633|NCT04640311|147290944|EQUIVALENCE|Bioequivalence was to be determined if the 90 percent (%) confidence interval (CI) of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|1.029|||||TWO_SIDED|90.0|0.977|1.083|||||Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.|||1.083|0.9770|
73874634|NCT04640311|147290944|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9496|||||TWO_SIDED|90.0|0.8914|1.012|||||Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.|||1.012|0.8914|
73874635|NCT04640311|147290944|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.9533|1.07|||||Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.|||1.070|0.9533|
73874636|NCT04640311|147290944|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9679|||||TWO_SIDED|90.0|0.9115|1.028|||||Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.|||1.028|0.9115|
73984456|NCT02592434|147513795|SUPERIORITY||LS Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.28||0.0065|TWO_SIDED|95.0|-1.36|-0.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.23|-1.36|0.0065
73984457|NCT02592434|147513795|SUPERIORITY||LS Mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27||0.0018|TWO_SIDED|95.0|-1.43|-0.34|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.34|-1.43|0.0018
73984458|NCT02592434|147513795|SUPERIORITY||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|95.0|-2.24|-0.61|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.61|-2.24|0.0010
73984459|NCT02592434|147513795|SUPERIORITY||LS Mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.4||0.0002|TWO_SIDED|95.0|-2.42|-0.81|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.81|-2.42|0.0002
74034058|NCT03342469|147620948|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1,15) = 3.65, p = 0.08||"Difference in inattentive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
73874637|NCT04640311|147290944|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9511|||||TWO_SIDED|90.0|0.8948|1.011|||||Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.|||1.011|0.8948|
73874638|NCT04640311|147290945|OTHER||Geometric mean ratio|1.042|||||TWO_SIDED|90.0|0.9308|1.166|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.|||1.166|0.9308|
73874639|NCT04640311|147290945|OTHER||Geometric mean ratio|1.048|||||TWO_SIDED|90.0|0.9349|1.175|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.|||1.175|0.9349|
73874640|NCT04640311|147290946|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9716|||||TWO_SIDED|90.0|0.8936|1.056|||||Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.|||1.056|0.8936|
73874641|NCT04640311|147290946|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9006|||||TWO_SIDED|90.0|0.8107|1.0|||||Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.|||1.000|0.8107|
73874642|NCT04640311|147290946|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9703|||||TWO_SIDED|90.0|0.8665|1.087|||||Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.|||1.087|0.8665|
73874643|NCT04640311|147290946|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9675|||||TWO_SIDED|90.0|0.8778|1.066|||||Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.|||1.066|0.8778|
73874644|NCT04640311|147290946|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.8606|||||TWO_SIDED|90.0|0.777|0.9532|||||Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.|||0.9532|0.7770|
73874645|NCT03956550|147290957|SUPERIORITY|||||||0.2978|||||||Mixed Models Analysis|||||||0.2978
73874646|NCT03956550|147290957|SUPERIORITY|||||||0.689|||||||Mixed Models Analysis|||||||0.6890
73874647|NCT03956550|147290958|SUPERIORITY|||||||0.1973|||||||Mixed Models Analysis|||||||0.1973
73874648|NCT03956550|147290958|SUPERIORITY|||||||0.942|||||||Mixed Models Analysis|||||||0.9420
73874649|NCT03956550|147290959|SUPERIORITY|||||||0.1597|||||||Mixed Models Analysis|||||||0.1597
73874650|NCT03956550|147290959|SUPERIORITY|||||||0.9719|||||||Mixed Models Analysis|||||||0.9719
73984460|NCT02592434|147513795|SUPERIORITY||LS Mean difference|-1.58|STANDARD_ERROR_OF_MEAN|0.43||0.0007|TWO_SIDED|95.0|-2.44|-0.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.71|-2.44|0.0007
73984461|NCT02592434|147513797|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.0398|TWO_SIDED|95.0|-0.83|-0.02|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.02|-0.83|0.0398
73984462|NCT02592434|147513797|SUPERIORITY||LS Mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.28||0.0011|TWO_SIDED|95.0|-1.49|-0.39|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.39|-1.49|0.0011
73984463|NCT02592434|147513797|SUPERIORITY||LS mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0131|TWO_SIDED|95.0|-1.47|-0.18|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.18|-1.47|0.0131
73984464|NCT02592434|147513797|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.32||0.0039|TWO_SIDED|95.0|-1.62|-0.33|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.33|-1.62|0.0039
73984465|NCT02592434|147513797|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.29||0.0711|TWO_SIDED|95.0|-1.1|0.05|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.05|-1.10|0.0711
73984466|NCT02592434|147513797|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.34||0.0658|TWO_SIDED|95.0|-1.3|0.04|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.04|-1.30|0.0658
73984467|NCT02592434|147513797|SUPERIORITY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.29||0.0154|TWO_SIDED|95.0|-1.31|-0.15|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.15|-1.31|0.0154
73984468|NCT02592434|147513799|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.4777|TWO_SIDED|95.0|-0.12|0.06|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.06|-0.12|0.4777
73984469|NCT02592434|147513799|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0779|TWO_SIDED|95.0|-0.16|0.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.01|-0.16|0.0779
73984470|NCT02592434|147513799|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0324|TWO_SIDED|95.0|-0.19|-0.01|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.01|-0.19|0.0324
73984471|NCT02592434|147513799|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.1061|TWO_SIDED|95.0|-0.2|0.02|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.02|-0.20|0.1061
73984472|NCT02592434|147513799|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0572|TWO_SIDED|95.0|-0.24|0.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.00|-0.24|0.0572
73874651|NCT03956550|147290960|SUPERIORITY|||||||0.1365|||||||Mixed Models Analysis|||||||0.1365
73984473|NCT02592434|147513799|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.0689|TWO_SIDED|95.0|-0.24|0.01|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.01|-0.24|0.0689
73984474|NCT02592434|147513799|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0292|TWO_SIDED|95.0|-0.22|-0.01|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.01|-0.22|0.0292
73984475|NCT02592434|147513801|SUPERIORITY||LS Mean Difference|3.79|STANDARD_ERROR_OF_MEAN|3.77||0.3179|TWO_SIDED|95.0|-3.72|11.31|||MMRM|||Global Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.31|-3.72|0.3179
73984476|NCT02592434|147513801|SUPERIORITY||LS mean difference|3.28|STANDARD_ERROR_OF_MEAN|4.27||0.4452|TWO_SIDED|95.0|-5.23|11.78|||MMRM|||Physical Functioning: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.78|-5.23|0.4452
73984477|NCT02592434|147513801|SUPERIORITY||LS mean difference|5.47|STANDARD_ERROR_OF_MEAN|4.76||0.2539|TWO_SIDED|95.0|-4.01|14.95|||MMRM|||Social Limitations: Emotional: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||14.95|-4.01|0.2539
73984478|NCT02592434|147513801|SUPERIORITY||LS mean difference|7.22|STANDARD_ERROR_OF_MEAN|5.56||0.1981|TWO_SIDED|95.0|-3.86|18.3|||MMRM|||Social Limitations: Physical Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||18.30|-3.86|0.1981
73984479|NCT02592434|147513801|SUPERIORITY||LS mean difference|8.26|STANDARD_ERROR_OF_MEAN|4.36||0.062|TWO_SIDED|95.0|-0.43|16.94|||MMRM|||Bodily Pain: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||16.94|-0.43|0.0620
74039529|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0004|TWO_SIDED|95.0|1.29|2.44|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.44|1.29|0.0004
73874652|NCT03956550|147290960|SUPERIORITY|||||||0.0604|||||||Mixed Models Analysis|||||||0.0604
73874653|NCT03956550|147290961|SUPERIORITY|||||||0.0989|||||||Mixed Models Analysis|||||||0.0989
73874654|NCT03956550|147290961|SUPERIORITY|||||||0.5487|||||||Mixed Models Analysis|||||||0.5487
73874655|NCT03956550|147290962|SUPERIORITY|||||||0.3572|||||||Cochran-Mantel-Haenszel|||||||0.3572
73874656|NCT03956550|147290962|SUPERIORITY|||||||0.5747|||||||Cochran-Mantel-Haenszel|||||||0.5747
73874657|NCT01359904|147290974|SUPERIORITY_OR_OTHER|||||||0.027|||||||Chi-squared|||||||0.027
73984480|NCT02592434|147513801|SUPERIORITY||LS mean difference|-3.43|STANDARD_ERROR_OF_MEAN|2.83||0.2291|TWO_SIDED|95.0|-9.06|2.2|||MMRM|||Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||2.20|-9.06|0.2291
73874658|NCT01359904|147290975|SUPERIORITY_OR_OTHER|||||||0.67|||||||Kruskal-Wallis|||post intervention hemoglobin A1c levels||||0.67
73874659|NCT01359904|147290976|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.20
73874660|NCT01359904|147290977|SUPERIORITY_OR_OTHER|||||||0.32|||||||Chi-squared|||||||0.32
73874661|NCT02660853|147290978|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||Baseline versus during exacerbation.||||0.745
73874662|NCT02660853|147290982|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||0.326
73874663|NCT02707146|147290997|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|||||Chi-squared|||||||
73874664|NCT03369418|147291030|SUPERIORITY|One tailed t-tests for independent groups were performed to test the hypothesis that active device will be superior to sham in decreasing the combined HAD score. This was accomplished by Contrast analysis within the framework of a random effects general linear mixed effects (RE GLMM) model.||||||0.013||||||A priori threshold for statistical significance was p\<.05.|t-test, 1 sided|||||||.013
73874665|NCT03369418|147291031|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.33
73874666|NCT01588561|147291062|OTHER||||||||||||||||||Increased signal: Insula, Putamen, Cingulate, Paracingulate, Calcarine cortex, Lingual gyrus, Frontal pole, Fusiform gyrus, Cerebellum. Decreased signal:Thalamus, Temporal gyri, Hippocampus (left), Caudate, Cerebellum|||
73874667|NCT01588561|147291063|OTHER||||||||||||||||||Increased signal: Insula, Putamen, Pallidum, Cingulate, Thalamus, Operculum, OBF cortex, Lingual gyrus, Cerebellum. Decreased signal: Hippocampus (left), Parahippocampus (left), Caudate, Cerebellum|||
74039530|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3456|TWO_SIDED|95.0|0.87|1.5|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.50|0.87|0.3456
73874668|NCT01588561|147291064|OTHER||||||||||||||||||Increased signal: Insula (bilateral), Cingulate, Pretcentralgyrus, Thalamus (bilateral), Putamen (bilateral), Pallidum (bilateral), Amygdala (bilateral), Ventral tegmental area, Accumbens Nuclei. Decreased signal: Insula (left inferior), OBF cortex, Frontal\&Temporal poles, Hippocampus (bilateral), Parahippocampus (bilateral), Accumbens nuclei, Cerebellum|||
73874669|NCT01337336|147291066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.002||95.0|1.08|1.56|||Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.56|1.08|0.002
73874670|NCT01337336|147291067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.002||95.0|1.02|2.38||COPD-related hospitalization|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.38|1.02|0.002
73874671|NCT01337336|147291067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.002||95.0|1.14|2.39||COPD-related ER visit|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.39|1.14|0.002
73874672|NCT01337336|147291067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.503||95.0|0.93|1.4|||Chi-squared|COPD-related physician + Rx visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.40|0.93|0.503
73874673|NCT01337336|147291067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71|||<|0.001||95.0|1.26|2.31|||Chi-squared|COPD-related hospitalization/ER visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.31|1.26|<0.001
73874674|NCT01337336|147291069|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.46||||0.0004||95.0|1.01|2.09||COPD-related hospitalization|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.09|1.01|0.0004
73874675|NCT01337336|147291069|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.27||||0.208||95.0|0.89|1.82||COPD-related ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.82|0.89|0.208
73874676|NCT01337336|147291069|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.09||||0.671||95.0|0.9|1.32||COPD-related physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.32|0.90|0.671
73874677|NCT01337336|147291069|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.31||||0.009||95.0|1.05|1.72||COPD-related hospitalization/ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.72|1.05|0.009
73984481|NCT02592434|147513801|SUPERIORITY||LS mean difference|-3.65|STANDARD_ERROR_OF_MEAN|3.9||0.353|TWO_SIDED|95.0|-11.43|4.13|||MMRM|||Global Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||4.13|-11.43|0.3530
74039531|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2771|TWO_SIDED|95.0|0.89|1.53|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.89|0.2771
73984482|NCT02592434|147513801|SUPERIORITY||LS mean difference|-3.47|STANDARD_ERROR_OF_MEAN|3.41||0.3114|TWO_SIDED|95.0|-10.26|3.32|||MMRM|||Mental Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||3.32|-10.26|0.3114
73984483|NCT02592434|147513801|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|4.46||0.8736|TWO_SIDED|95.0|-8.18|9.61|||MMRM|||Self Esteem: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||9.61|-8.18|0.8736
73984484|NCT02592434|147513801|SUPERIORITY||LS mean difference|1.77|STANDARD_ERROR_OF_MEAN|2.48||0.4778|TWO_SIDED|95.0|-3.18|6.72|||MMRM|||General Health Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||6.72|-3.18|0.4778
73984485|NCT02592434|147513801|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8909|TWO_SIDED|95.0|-0.28|0.25|||MMRM|||Change in Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||0.25|-0.28|0.8909
73984486|NCT02592434|147513801|SUPERIORITY||LS mean difference|8.97|STANDARD_ERROR_OF_MEAN|5.81||0.127|TWO_SIDED|95.0|-2.61|20.55|||MMRM|||Emotional Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||20.55|-2.61|0.1270
73984487|NCT02592434|147513801|SUPERIORITY||LS mean difference|-6.72|STANDARD_ERROR_OF_MEAN|3.96||0.0944|TWO_SIDED|95.0|-14.62|1.18|||MMRM|||Time Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||1.18|-14.62|0.0944
73984488|NCT02592434|147513801|SUPERIORITY||LS mean difference|-8.6|STANDARD_ERROR_OF_MEAN|3.23||0.0095|TWO_SIDED|95.0|-15.03|-2.17|||MMRM|||Family Activities: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.17|-15.03|0.0095
73984489|NCT02592434|147513801|SUPERIORITY||LS mean difference|2.59|STANDARD_ERROR_OF_MEAN|4.29||0.5474|TWO_SIDED|95.0|-5.96|11.14|||MMRM|||Family Cohesion: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.14|-5.96|0.5474
73984490|NCT02592434|147513801|SUPERIORITY||LS mean difference|3.48|STANDARD_ERROR_OF_MEAN|2.03||0.0902|TWO_SIDED|95.0|-0.56|7.52|||MMRM|||Physical Health Summary: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||7.52|-0.56|0.0902
73984491|NCT02592434|147513801|SUPERIORITY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|1.67||0.6539|TWO_SIDED|95.0|-4.07|2.57|||MMRM|||Psychosocial Health Summary : Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||2.57|-4.07|0.6539
73984492|NCT02592434|147513803|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.1894|TWO_SIDED|95.0|-0.8|0.16|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.16|-0.80|0.1894
73984493|NCT02592434|147513803|SUPERIORITY||LS mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.31||0.0026|TWO_SIDED|95.0|-1.56|-0.34|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.34|-1.56|0.0026
73984494|NCT02592434|147513803|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.31||0.0067|TWO_SIDED|95.0|-1.5|-0.25|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.25|-1.50|0.0067
73874678|NCT01337336|147291069|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.16||||0.052||95.0|0.98|1.37||COPD-related hospitalization/ER visit/physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.37|0.98|0.052
73874679|NCT01618669|147291070|NON_INFERIORITY_OR_EQUIVALENCE|If the lower confidence bound of the 1-sided alpha level of 0.025 of the difference in the proportion of participants with majority reader self-agreement exceeded -0.075, non-inferiority would be demonstrated.|Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.015|||TWO_SIDED|95.0|-0.06|0.0|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone|||-0.00|-0.06|
73984495|NCT02592434|147513803|SUPERIORITY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.37||0.0091|TWO_SIDED|95.0|-1.73|-0.25|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.25|-1.73|0.0091
73984496|NCT02592434|147513803|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.28||0.0632|TWO_SIDED|95.0|-1.09|0.03|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.03|-1.09|0.0632
73984497|NCT02592434|147513803|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.32||0.0306|TWO_SIDED|95.0|-1.35|-0.07|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.07|-1.35|0.0306
73984498|NCT02592434|147513803|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.31||0.0118|TWO_SIDED|95.0|-1.41|-0.18|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.18|-1.41|0.0118
73984499|NCT04748445|147513839|OTHER||Slope|0.065|||<|0.0001|TWO_SIDED|90.0|0.046|0.083|||Mixed Models Analysis|||Chills||0.083|0.046|<.0001
73984500|NCT04748445|147513839|OTHER||Slope|0.281|||<|0.0001|TWO_SIDED|90.0|0.221|0.341|||Mixed Models Analysis|||Cough||0.341|0.221|<.0001
73984501|NCT04748445|147513839|OTHER||Slope|0.036|||<|0.0001|TWO_SIDED|90.0|0.023|0.048|||Mixed Models Analysis|||Diarrhea||0.048|0.023|<.0001
73984502|NCT04748445|147513839|OTHER||Slope|0.113|||<|0.0001|TWO_SIDED|90.0|0.069|0.156|||Mixed Models Analysis|||Difficulty breathing||0.156|0.069|<.0001
73874680|NCT01618669|147291072|NON_INFERIORITY_OR_EQUIVALENCE|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.10 in order to demonstrate non-inferiority.|Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.14|0.11|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone|||0.11|-0.14|
73874681|NCT01618669|147291073|NON_INFERIORITY_OR_EQUIVALENCE|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.133 in order to demonstrate non-inferiority. Non-inferiority could not be assessed because of insufficient data in the Regadenoson Alone group.|Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|-0.07|0.04||||||||0.04|-0.07|
73984503|NCT04748445|147513839|OTHER||Slope|0.259|||<|0.0001|TWO_SIDED|90.0|0.206|0.312|||Mixed Models Analysis|||Fatigue||0.312|0.206|<.0001
73984504|NCT04748445|147513839|OTHER||Slope|0.029|||<|0.0001|TWO_SIDED|90.0|0.02|0.037|||Mixed Models Analysis|||Fever||0.037|0.020|<.0001
73984505|NCT04748445|147513839|OTHER||Slope|0.194|||<|0.0001|TWO_SIDED|90.0|0.148|0.241|||Mixed Models Analysis|||Headache||0.241|0.148|<.0001
73984506|NCT04748445|147513839|OTHER||Slope|0.103||||0.0002|TWO_SIDED|90.0|0.059|0.148|||Mixed Models Analysis|||Loss of taste or smell||0.148|0.059|0.0002
73984507|NCT04748445|147513839|OTHER||Slope|0.181|||<|0.0001|TWO_SIDED|90.0|0.137|0.226|||Mixed Models Analysis|||Muscle pain||0.226|0.137|<.0001
73984508|NCT04748445|147513839|OTHER||Slope|0.044|||<|0.0001|TWO_SIDED|90.0|0.028|0.06|||Mixed Models Analysis|||Nausea||0.060|0.028|<.0001
73984509|NCT04748445|147513839|OTHER||Slope|0.03||||0.0007|TWO_SIDED|90.0|0.016|0.044|||Mixed Models Analysis|||Rigors||0.044|0.016|0.0007
73984510|NCT04748445|147513839|OTHER||Slope|0.159|||<|0.0001|TWO_SIDED|90.0|0.123|0.195|||Mixed Models Analysis|||Runny nose||0.195|0.123|<.0001
74034059|NCT03342469|147620948|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in hyperactive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
74039532|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0594|TWO_SIDED|95.0|0.98|2.41|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.41|0.98|0.0594
73874682|NCT01618669|147291074|SUPERIORITY_OR_OTHER||Difference|0.02|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|-0.03|0.06||||||||0.06|-0.03|
73874683|NCT01702558|147291084|SUPERIORITY||Difference in Response Rates|8.2||||0.336|TWO_SIDED|90.0|-4.5|20.9|||Fisher Exact||90% CI was estimated using Hauck-Anderson approach.|||20.9|-4.5|0.336
73874684|NCT03259087|147291140|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|1.07|1.47|||||GMR is ratio of Experimental Group / Healthy Group|||1.47|1.07|
73874685|NCT03259087|147291140|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.7|||||TWO_SIDED|90.0|1.42|2.02|||||GMR is ratio of Experimental Group / Healthy Group|||2.02|1.42|
73874686|NCT03259087|147291140|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.98|||||TWO_SIDED|90.0|2.2|4.04|||||GMR is ratio of Experimental Group / Healthy Group|||4.04|2.20|
73874687|NCT03259087|147291141|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|1.06|1.46|||||GMR is ratio of Experimental Group / Healthy Group|||1.46|1.06|
73874688|NCT03259087|147291141|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.68|||||TWO_SIDED|90.0|1.41|1.99|||||GMR is ratio of Experimental Group / Healthy Group|||1.99|1.41|
73874689|NCT03259087|147291141|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.91|||||TWO_SIDED|90.0|2.17|3.9|||||GMR is ratio of Experimental Group / Healthy Group|||3.90|2.17|
73984511|NCT04748445|147513839|OTHER||Slope|0.222|||<|0.0001|TWO_SIDED|90.0|0.168|0.277|||Mixed Models Analysis|||Sore throat||0.277|0.168|<.0001
73984512|NCT04748445|147513839|OTHER||Slope|0.337|||<|0.0001|TWO_SIDED|90.0|0.264|0.411|||Mixed Models Analysis|||Stuffy/blocked nose||0.411|0.264|<.0001
73984513|NCT04748445|147513839|OTHER||Slope|0.005||||0.0053|TWO_SIDED|90.0|0.002|0.007|||Mixed Models Analysis|||Vomiting||0.007|0.002|0.0053
73984514|NCT04748445|147513839|OTHER||Slope|0.049||||0.0057|TWO_SIDED|90.0|0.02|0.078|||Mixed Models Analysis|||Wheezing||0.078|0.020|0.0057
73984515|NCT04748445|147513839|OTHER||Slope|2.644|||<|0.0001|TWO_SIDED|90.0|2.101|3.188|||Mixed Models Analysis|||Mean of daily total symptom score||3.188|2.101|<.0001
73984516|NCT04748445|147513840|OTHER||Slope|-1.519|STANDARD_ERROR_OF_MEAN|2.769|<|0.0001|TWO_SIDED|90.0|-1.978|-1.06|||Mixed Models Analysis|||AHH\_Max Phonation Time (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2).||-1.060|-1.978|<.0001
73984517|NCT04748445|147513840|OTHER||Slope|6.899|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|90.0|||||Mixed Models Analysis|||EE\_Jitter Local Absolute (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-8).||||<.0001
73984518|NCT04748445|147513840|OTHER||Slope|-1.743|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|90.0|||||Mixed Models Analysis|||MM\_Jitter Local Absolute (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-7).||||<.0001
73984519|NCT04748445|147513841|OTHER||Slope|-1.326|STANDARD_ERROR_OF_MEAN|1.174||0.9103|TWO_SIDED|90.0|-2.079|1.814|||Mixed Models Analysis|||EE\_Cepstral Peak Prominence (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||1.814|-2.079|0.9103
73984520|NCT04748445|147513841|OTHER||Slope|0.007667|STANDARD_ERROR_OF_MEAN|1.741||0.6605|TWO_SIDED|90.0|-0.02119|0.03653|||Mixed Models Analysis|||EE\_Harmonicity (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03653|-0.02119|0.6605
73984521|NCT04748445|147513841|OTHER||Slope|1.268|STANDARD_ERROR_OF_MEAN|2.82|<|0.0001|TWO_SIDED|90.0|0.8012|1.736|||Mixed Models Analysis|||EE\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.736|0.8012|<.0001
73984522|NCT04748445|147513841|OTHER||Slope|-1.752|STANDARD_ERROR_OF_MEAN|2.127||0.4117|TWO_SIDED|90.0|-5.276|1.773|||Mixed Models Analysis|||EE\_MFCC mean 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-1).||1.773|-5.276|0.4117
73984523|NCT04748445|147513841|OTHER||Slope|1.39|STANDARD_ERROR_OF_MEAN|1.262||0.2728|TWO_SIDED|90.0|-7.012|3.482|||Mixed Models Analysis|||EE\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-1. For lower limit it was 10\^-2).||3.482|-7.012|0.2728
73984524|NCT04748445|147513841|OTHER||Slope|-1.407|STANDARD_ERROR_OF_MEAN|1.194||0.2411|TWO_SIDED|90.0|-3.385|5.724|||Mixed Models Analysis|||EE\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-1. For upper limit it was 10\^-2).||5.724|-3.385|0.2411
73984525|NCT04748445|147513841|OTHER||Slope|-0.004466|STANDARD_ERROR_OF_MEAN|8.869||0.9599|TWO_SIDED|90.0|-0.1514|0.1425|||Mixed Models Analysis|||EE\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1425|-0.1514|0.9599
73984526|NCT04748445|147513841|OTHER||Slope|-0.1572|STANDARD_ERROR_OF_MEAN|9.127||0.0875|TWO_SIDED|90.0|-0.3084|-0.005942|||Mixed Models Analysis|||EE\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.005942|-0.3084|0.0875
73984527|NCT04748445|147513841|OTHER||Slope|1.248|STANDARD_ERROR_OF_MEAN|7.598||0.1029|TWO_SIDED|90.0|-1.072|2.507|||Mixed Models Analysis|||EE\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2 and for lower limit it was 10\^-3).||2.507|-1.072|0.1029
73984528|NCT04748445|147513841|OTHER||Slope|-1.054|STANDARD_ERROR_OF_MEAN|7.218||0.1468|TWO_SIDED|90.0|-2.25|1.423|||Mixed Models Analysis|||EE\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-1. For upper limit and dispersion value it was 10\^-2).||1.423|-2.250|0.1468
73984529|NCT04748445|147513841|OTHER||Slope|0.05944|STANDARD_ERROR_OF_MEAN|6.536||0.3649|TWO_SIDED|90.0|-0.04887|0.1678|||Mixed Models Analysis|||EE\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1678|-0.04887|0.3649
73984530|NCT04748445|147513841|OTHER||Slope|-0.03115|STANDARD_ERROR_OF_MEAN|6.007||0.605|TWO_SIDED|90.0|-0.1307|0.06839|||Mixed Models Analysis|||EE\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06839|-0.1307|0.6050
73984531|NCT04748445|147513841|OTHER||Slope|-0.01908|STANDARD_ERROR_OF_MEAN|5.932||0.7483|TWO_SIDED|90.0|-0.1174|0.07922|||Mixed Models Analysis|||EE\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.07922|-0.1174|0.7483
73984532|NCT04748445|147513841|OTHER||Slope|-6.574|STANDARD_ERROR_OF_MEAN|5.105||0.9897|TWO_SIDED|90.0|-8.526|8.394|||Mixed Models Analysis|||EE\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-4).||8.394|-8.526|0.9897
73984533|NCT04748445|147513841|OTHER||Slope|5.026|STANDARD_ERROR_OF_MEAN|5.176||0.9228|TWO_SIDED|90.0|-8.074|9.08|||Mixed Models Analysis|||EE\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||9.080|-8.074|0.9228
73984534|NCT04748445|147513841|OTHER||Slope|0.08365|STANDARD_ERROR_OF_MEAN|2.873||0.0043|TWO_SIDED|90.0|0.03604|0.1313|||Mixed Models Analysis|||EE\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1313|0.03604|0.0043
73984535|NCT04748445|147513841|OTHER||Slope|0.02906|STANDARD_ERROR_OF_MEAN|1.181||0.0153|TWO_SIDED|90.0|0.009486|0.04863|||Mixed Models Analysis|||EE\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.04863|0.009486|0.0153
74089684|NCT00904748|147732123|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|90.0|-0.14|0.5|||ANOVA|||Difference in Tmax between Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||0.50|-0.14|
73984536|NCT04748445|147513841|OTHER||Slope|3.96|STANDARD_ERROR_OF_MEAN|1.447||0.0071|TWO_SIDED|90.0|1.563|6.357|||Mixed Models Analysis|||EE\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||6.357|1.563|0.0071
73984537|NCT04748445|147513841|OTHER||Slope|2.816|STANDARD_ERROR_OF_MEAN|1.026||0.007|TWO_SIDED|90.0|1.115|4.516|||Mixed Models Analysis|||EE\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||4.516|1.115|0.0070
73984538|NCT04748445|147513841|OTHER||Slope|0.007814|STANDARD_ERROR_OF_MEAN|1.034||0.4513|TWO_SIDED|90.0|-0.009323|0.02495|||Mixed Models Analysis|||EE\_MFCC std 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02495|-0.009323|0.4513
73984539|NCT04748445|147513841|OTHER||Slope|1.151|STANDARD_ERROR_OF_MEAN|8.443||0.1753|TWO_SIDED|90.0|-2.483|2.55|||Mixed Models Analysis|||EE\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-2. For lower limit and dispersion value it was 10\^-3).||2.550|-2.483|0.1753
73984540|NCT04748445|147513841|OTHER||Slope|2.528|STANDARD_ERROR_OF_MEAN|8.228||0.0026|TWO_SIDED|90.0|1.164|3.891|||Mixed Models Analysis|||EE\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion it was 10\^-3).||3.891|1.164|0.0026
73984541|NCT04748445|147513841|OTHER||Slope|0.01755|STANDARD_ERROR_OF_MEAN|7.204||0.0162|TWO_SIDED|90.0|0.005616|0.02949|||Mixed Models Analysis|||EE\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02949|0.005616|0.0162
74089685|NCT00904748|147732123|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|90.0|-0.27|0.28|||ANOVA|||Difference in Tmax between Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||0.28|-0.27|
73984542|NCT04748445|147513841|OTHER||Slope|2.673|STANDARD_ERROR_OF_MEAN|5.892|<|0.0001|TWO_SIDED|90.0|1.697|3.65|||Mixed Models Analysis|||EE\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||3.650|1.697|<.0001
73984543|NCT04748445|147513841|OTHER||Slope|0.01394|STANDARD_ERROR_OF_MEAN|5.642||0.0148|TWO_SIDED|90.0|0.004595|0.02329|||Mixed Models Analysis|||EE\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02329|0.004595|0.0148
73984544|NCT04748445|147513841|OTHER||Slope|0.01547|STANDARD_ERROR_OF_MEAN|6.666||0.0219|TWO_SIDED|90.0|0.004425|0.02652|||Mixed Models Analysis|||EE\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02652|0.004425|0.0219
73984545|NCT04748445|147513841|OTHER||Slope|1.118|STANDARD_ERROR_OF_MEAN|6.122||0.0703|TWO_SIDED|90.0|1.032|2.132|||Mixed Models Analysis|||EE\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-2. For lower limit and dispersion value it was 10\^-3).||2.132|1.032|0.0703
73984546|NCT04748445|147513841|OTHER||Slope|0.0116|STANDARD_ERROR_OF_MEAN|5.226||0.0282|TWO_SIDED|90.0|0.00294|0.02026|||Mixed Models Analysis|||EE\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02026|0.002940|0.0282
73984547|NCT04748445|147513841|OTHER||Slope|0.04771|STANDARD_ERROR_OF_MEAN|3.351||0.157|TWO_SIDED|90.0|-0.007823|0.1032|||Mixed Models Analysis|||EE\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1032|-0.007823|0.1570
73984548|NCT04748445|147513841|OTHER||Slope|0.0008053|STANDARD_ERROR_OF_MEAN|9.807||0.4131|TWO_SIDED|90.0|-0.0008199|0.002431|||Mixed Models Analysis|||EE\_Shimmer Local dB (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002431|-0.0008199|0.4131
73984549|NCT04748445|147513841|OTHER||Slope|-0.03945|STANDARD_ERROR_OF_MEAN|1.892||0.0391|TWO_SIDED|90.0|-0.0708|-0.008096|||Mixed Models Analysis|||EE\_Spectral Flatness (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.008096|-0.07080|0.0391
73984550|NCT04748445|147513841|OTHER||Slope|-0.07075|STANDARD_ERROR_OF_MEAN|8.409||0.4018|TWO_SIDED|90.0|-0.2101|0.0686|||Mixed Models Analysis|||EE\_Third Octave Band (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06860|-0.2101|0.4018
73984551|NCT04748445|147513841|OTHER||Slope|1.658|STANDARD_ERROR_OF_MEAN|3.607||0.6466|TWO_SIDED|90.0|-4.319|7.635|||Mixed Models Analysis|||EE\_VLHR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||7.635|-4.319|0.6466
73984552|NCT04748445|147513841|OTHER||Slope|1.172|STANDARD_ERROR_OF_MEAN|1.423||0.4118|TWO_SIDED|90.0|-1.186|3.53|||Mixed Models Analysis|||MM\_Cepstral Peak Prominence (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||3.530|-1.186|0.4118
73984553|NCT04748445|147513841|OTHER||Slope|-1.282|STANDARD_ERROR_OF_MEAN|1.965||0.9481|TWO_SIDED|90.0|-3.385|3.129|||Mixed Models Analysis|||MM\_Harmonicity (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||3.129|-3.385|0.9481
74039533|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0105|TWO_SIDED|95.0|1.14|2.75|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.75|1.14|0.0105
73874690|NCT03259087|147291142|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|1.04|1.4|||||GMR is ratio of Experimental Group / Healthy Group|||1.40|1.04|
73874691|NCT03259087|147291142|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.59|||||TWO_SIDED|90.0|1.36|1.86|||||GMR is ratio of Experimental Group / Healthy Group|||1.86|1.36|
73874692|NCT03259087|147291142|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.32|||||TWO_SIDED|90.0|1.82|2.97|||||GMR is ratio of Experimental Group / Healthy Group|||2.97|1.82|
73874693|NCT03259087|147291143|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.99|||||TWO_SIDED|90.0|0.84|1.16|||||GMR is ratio of Experimental Group / Healthy Group|||1.16|0.84|
73874694|NCT03259087|147291143|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.03|||||TWO_SIDED|90.0|0.9|1.18|||||GMR is ratio of Experimental Group / Healthy Group|||1.18|0.90|
73984554|NCT04748445|147513841|OTHER||Slope|0.9159|STANDARD_ERROR_OF_MEAN|2.641||0.0007|TWO_SIDED|90.0|0.4783|1.354|||Mixed Models Analysis|||MM\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.354|0.4783|0.0007
73984555|NCT04748445|147513841|OTHER||Slope|-2.18|STANDARD_ERROR_OF_MEAN|1.894||0.2519|TWO_SIDED|90.0|-5.319|9.585|||Mixed Models Analysis|||MM\_MFCC mean 02 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-1. For upper limit it was 10\^-2).||9.585|-5.319|0.2519
73984556|NCT04748445|147513841|OTHER||Slope|1.821|STANDARD_ERROR_OF_MEAN|1.028||0.0791|TWO_SIDED|90.0|1.166|3.524|||Mixed Models Analysis|||MM\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-1. For lower limit it was 10\^-2).||3.524|1.166|0.0791
73984557|NCT04748445|147513841|OTHER||Slope|-0.2064|STANDARD_ERROR_OF_MEAN|8.474||0.0163|TWO_SIDED|90.0|-0.3468|-0.06599|||Mixed Models Analysis|||MM\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.06599|-0.3468|0.0163
73984558|NCT04748445|147513841|OTHER||Slope|-1.265|STANDARD_ERROR_OF_MEAN|9.67||0.1932|TWO_SIDED|90.0|-2.867|3.375|||Mixed Models Analysis|||MM\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and dispersion value it was 10\^-2. For lower limit and estimated value it was 10\^-1).||3.375|-2.867|0.1932
73984559|NCT04748445|147513841|OTHER||Slope|0.02851|STANDARD_ERROR_OF_MEAN|9.96||0.7752|TWO_SIDED|90.0|-0.1365|0.1936|||Mixed Models Analysis|||MM\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1936|-0.1365|0.7752
73984560|NCT04748445|147513841|OTHER||Slope|1.209|STANDARD_ERROR_OF_MEAN|7.569||0.1126|TWO_SIDED|90.0|-4.48|2.464|||Mixed Models Analysis|||MM\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-1. For lower limit it was 10\^-3. For dispersion value it was 10\^-2).||2.464|-4.480|0.1126
73984561|NCT04748445|147513841|OTHER||Slope|-0.2215|STANDARD_ERROR_OF_MEAN|8.498||0.0102|TWO_SIDED|90.0|-0.3624|-0.08072|||Mixed Models Analysis|||MM\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.08072|-0.3624|0.0102
73984562|NCT04748445|147513841|OTHER||Slope|0.0556|STANDARD_ERROR_OF_MEAN|7.072||0.4332|TWO_SIDED|90.0|-0.06159|0.1728|||Mixed Models Analysis|||MM\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1728|-0.06159|0.4332
73984563|NCT04748445|147513841|OTHER||Slope|0.01214|STANDARD_ERROR_OF_MEAN|6.19||0.8448|TWO_SIDED|90.0|-0.09044|0.1147|||Mixed Models Analysis|||MM\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1147|-0.09044|0.8448
73984564|NCT04748445|147513841|OTHER||Slope|-0.1106|STANDARD_ERROR_OF_MEAN|4.852||0.0244|TWO_SIDED|90.0|-0.191|-0.03016|||Mixed Models Analysis|||MM\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.03016|-0.1910|0.0244
73984565|NCT04748445|147513841|OTHER||Slope|-0.04884|STANDARD_ERROR_OF_MEAN|4.827||0.3136|TWO_SIDED|90.0|-0.1288|0.03115|||Mixed Models Analysis|||MM\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03115|-0.1288|0.3136
73984566|NCT04748445|147513841|OTHER||Slope|0.036|STANDARD_ERROR_OF_MEAN|5.634||0.524|TWO_SIDED|90.0|-0.05736|0.1294|||Mixed Models Analysis|||MM\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1294|-0.05736|0.5240
73984567|NCT04748445|147513841|OTHER||Slope|2.909|STANDARD_ERROR_OF_MEAN|3.096||0.3493|TWO_SIDED|90.0|-2.222|8.039|||Mixed Models Analysis|||MM\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||8.039|-2.222|0.3493
73984568|NCT04748445|147513841|OTHER||Slope|1.72|STANDARD_ERROR_OF_MEAN|2.595||0.5087|TWO_SIDED|90.0|-2.58|6.019|||Mixed Models Analysis|||MM\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||6.019|-2.580|0.5087
73984569|NCT04748445|147513841|OTHER||Slope|0.004403|STANDARD_ERROR_OF_MEAN|1.503||0.7701|TWO_SIDED|90.0|-0.02051|0.02931|||Mixed Models Analysis|||MM\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02931|-0.02051|0.7701
73984570|NCT04748445|147513841|OTHER||Slope|0.007542|STANDARD_ERROR_OF_MEAN|1.639||0.6461|TWO_SIDED|90.0|-0.01961|0.0347|||Mixed Models Analysis|||MM\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03470|-0.01961|0.6461
73984571|NCT04748445|147513841|OTHER||Slope|2.386|STANDARD_ERROR_OF_MEAN|8.233||0.0044|TWO_SIDED|90.0|1.022|3.75|||Mixed Models Analysis|||MM\_MFCC std 05 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||3.750|1.022|0.0044
73984572|NCT04748445|147513841|OTHER||Slope|1.593|STANDARD_ERROR_OF_MEAN|1.243||0.2022|TWO_SIDED|90.0|-4.663|3.652|||Mixed Models Analysis|||MM\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.652|-4.663|0.2022
73984573|NCT04748445|147513841|OTHER||Slope|0.002902|STANDARD_ERROR_OF_MEAN|1.082||0.789|TWO_SIDED|90.0|-0.01503|0.02084|||Mixed Models Analysis|||MM\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02084|-0.01503|0.7890
73874695|NCT03259087|147291143|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.11|||||TWO_SIDED|90.0|0.95|1.29|||||GMR is ratio of Experimental Group / Healthy Group|||1.29|0.95|
73984574|NCT04748445|147513841|OTHER||Slope|1.615|STANDARD_ERROR_OF_MEAN|1.118||0.151|TWO_SIDED|90.0|-2.371|3.467|||Mixed Models Analysis|||MM\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.467|-2.371|0.1510
73984575|NCT04748445|147513841|OTHER||Slope|1.116|STANDARD_ERROR_OF_MEAN|1.104||0.3138|TWO_SIDED|90.0|-7.126|2.945|||Mixed Models Analysis|||MM\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||2.945|-7.126|0.3138
73984576|NCT04748445|147513841|OTHER||Slope|-0.002168|STANDARD_ERROR_OF_MEAN|9.632||0.8223|TWO_SIDED|90.0|-0.01813|0.01379|||Mixed Models Analysis|||MM\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01379|-0.01813|0.8223
73984577|NCT04748445|147513841|OTHER||Slope|1.394|STANDARD_ERROR_OF_MEAN|1.081||0.1997|TWO_SIDED|90.0|-3.978|3.185|||Mixed Models Analysis|||MM\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.185|-3.978|0.1997
73984578|NCT04748445|147513841|OTHER||Slope|0.01375|STANDARD_ERROR_OF_MEAN|6.622||0.0398|TWO_SIDED|90.0|0.00278|0.02473|||Mixed Models Analysis|||MM\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02473|0.002780|0.0398
73984579|NCT04748445|147513841|OTHER||Slope|-0.002892|STANDARD_ERROR_OF_MEAN|1.205||0.8107|TWO_SIDED|90.0|-0.02286|0.01707|||Mixed Models Analysis|||MM\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.01707|-0.02286|0.8107
73984580|NCT04748445|147513841|OTHER||Slope|-3.105|STANDARD_ERROR_OF_MEAN|3.256||0.9242|TWO_SIDED|90.0|-5.706|5.085|||Mixed Models Analysis|||MM\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||5.085|-5.706|0.9242
73874696|NCT03259087|147291145|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.8|||||TWO_SIDED|90.0|0.68|0.94|||||GMR is ratio of Experimental Group / Healthy Group|||0.94|0.68|
73874697|NCT03259087|147291145|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.59|||||TWO_SIDED|90.0|0.49|0.7|||||GMR is ratio of Experimental Group / Healthy Group|||0.70|0.49|
73874698|NCT03259087|147291145|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.34|||||TWO_SIDED|90.0|0.25|0.45|||||GMR is ratio of Experimental Group / Healthy Group|||0.45|0.25|
73874699|NCT03259087|147291149|OTHER||Geometric Least Squares Mean Ratio (GMR)|3.97|||||TWO_SIDED|90.0|3.26|4.82|||||GMR is ratio of Experimental Group / Healthy Group|||4.82|3.26|
73874700|NCT03259087|147291149|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.58|||||TWO_SIDED|90.0|1.3|1.92|||||GMR is ratio of Experimental Group / Healthy Group|||1.92|1.30|
73984581|NCT04748445|147513841|OTHER||Slope|0.0006145|STANDARD_ERROR_OF_MEAN|9.704||0.5277|TWO_SIDED|90.0|-0.0009936|0.002223|||Mixed Models Analysis|||MM\_Shimmer Local dB (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002223|-0.0009936|0.5277
73984582|NCT04748445|147513841|OTHER||Slope|-2.911|STANDARD_ERROR_OF_MEAN|1.969||0.1418|TWO_SIDED|90.0|-6.174|3.522|||Mixed Models Analysis|||MM\_Spectral Flatness (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-2. For upper limit it was 10\^-3).||3.522|-6.174|0.1418
73984583|NCT04748445|147513841|OTHER||Slope|-0.1487|STANDARD_ERROR_OF_MEAN|8.77||0.0924|TWO_SIDED|90.0|-0.294|-0.003375|||Mixed Models Analysis|||MM\_Third Octave Band (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.003375|-0.2940|0.0924
74034060|NCT03342469|147620948|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in total ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
74039534|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.29||||0.236|TWO_SIDED|95.0|0.85|1.98|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.98|0.85|0.2360
74039535|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.19||||0.3746|TWO_SIDED|95.0|0.81|1.75|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.75|0.81|0.3746
73874701|NCT03259087|147291150|OTHER||Geometric Least Squares Mean Ratio (GMR)|3.63|||||TWO_SIDED|90.0|3.03|4.36|||||GMR is ratio of Experimental Group / Healthy Group|||4.36|3.03|
73874702|NCT03259087|147291150|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.46|||||TWO_SIDED|90.0|1.22|1.75|||||GMR is ratio of Experimental Group / Healthy Group|||1.75|1.22|
73874703|NCT03259087|147291151|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.61|||||TWO_SIDED|90.0|2.23|3.06|||||GMR is ratio of Experimental Group / Healthy Group|||3.06|2.23|
73874704|NCT03259087|147291151|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.95|1.25|||||GMR is ratio of Experimental Group / Healthy Group|||1.25|0.95|
73874705|NCT03259087|147291152|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.98|||||TWO_SIDED|90.0|0.84|1.14|||||GMR is ratio of Experimental Group / Healthy Group|||1.14|0.84|
73874706|NCT03259087|147291152|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group|||1.20|0.75|
73874707|NCT03259087|147291153|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.99|||||TWO_SIDED|90.0|0.85|1.16|||||GMR is ratio of Experimental Group / Healthy Group|||1.16|0.85|
73874708|NCT03259087|147291153|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group|||1.20|0.75|
73874709|NCT03259087|147291154|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.25|||||TWO_SIDED|90.0|0.21|0.31|||||GMR is ratio of Experimental Group / Healthy Group|||0.31|0.21|
73874710|NCT03259087|147291154|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.63|||||TWO_SIDED|95.0|0.52|0.77|||||GMR is ratio of Experimental Group / Healthy Group|||0.77|0.52|
73874711|NCT03259087|147291158|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.9|||||TWO_SIDED|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group|||1.11|0.74|
73874712|NCT03259087|147291158|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.64|||||TWO_SIDED|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group|||0.88|0.47|
73874713|NCT03259087|147291158|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.3|||||TWO_SIDED|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group|||0.43|0.21|
73874714|NCT03259087|147291159|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.75|||||TWO_SIDED|90.0|0.57|0.98|||||GMR is ratio of Experimental Group / Healthy Group|||0.98|0.57|
73874715|NCT03259087|147291159|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.4|||||TWO_SIDED|90.0|0.31|0.53|||||GMR is ratio of Experimental Group / Healthy Group|||0.53|0.31|
73874716|NCT03259087|147291159|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.13|||||TWO_SIDED|90.0|0.08|0.22|||||GMR is ratio of Experimental Group / Healthy Group|||0.22|0.08|
73874717|NCT03259087|147291160|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.9|||||TWO_SIDED|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group|||1.11|0.74|
73874718|NCT03259087|147291160|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.64|||||TWO_SIDED|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group|||0.88|0.47|
73874719|NCT03259087|147291160|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.3|||||TWO_SIDED|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group|||0.43|0.21|
73874720|NCT04950465|147291177|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2639|TWO_SIDED|95.0|-0.12|0.43|||ANCOVA|||||0.43|-0.12|0.2639
73874721|NCT04950465|147291178|SUPERIORITY|||||||0.6978|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 4||||0.6978
73984584|NCT04748445|147513841|OTHER||Slope|3.089|STANDARD_ERROR_OF_MEAN|3.396||0.9277|TWO_SIDED|90.0|-5.318|5.936|||Mixed Models Analysis|||MM\_VLHR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||5.936|-5.318|0.9277
73874722|NCT04950465|147291178|SUPERIORITY|||||||0.813|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 8||||0.8130
73984585|NCT04748445|147513841|OTHER||Slope|0.8362|STANDARD_ERROR_OF_MEAN|2.077|<|0.0001|TWO_SIDED|90.0|0.492|1.18|||Mixed Models Analysis|||READ\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.180|0.4920|<.0001
73984586|NCT04748445|147513841|OTHER||Slope|0.03559|STANDARD_ERROR_OF_MEAN|1.147||0.7568|TWO_SIDED|90.0|-0.1545|0.2256|||Mixed Models Analysis|||READ\_MFCC mean 02 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||0.2256|-0.1545|0.7568
73984587|NCT04748445|147513841|OTHER||Slope|0.2043|STANDARD_ERROR_OF_MEAN|7.752||0.0095|TWO_SIDED|90.0|0.07585|0.3328|||Mixed Models Analysis|||READ\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.3328|0.07585|0.0095
73984588|NCT04748445|147513841|OTHER||Slope|-0.0828|STANDARD_ERROR_OF_MEAN|6.413||0.1991|TWO_SIDED|90.0|-0.1891|0.02348|||Mixed Models Analysis|||READ\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02348|-0.1891|0.1991
73984589|NCT04748445|147513841|OTHER||Slope|-0.02415|STANDARD_ERROR_OF_MEAN|5.26||0.6469|TWO_SIDED|90.0|-0.1113|0.06301|||Mixed Models Analysis|||READ\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06301|-0.1113|0.6469
73984590|NCT04748445|147513841|OTHER||Slope|-0.1209|STANDARD_ERROR_OF_MEAN|4.904||0.015|TWO_SIDED|90.0|-0.2022|-0.03967|||Mixed Models Analysis|||READ\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.03967|-0.2022|0.0150
73984591|NCT04748445|147513841|OTHER||Slope|0.02617|STANDARD_ERROR_OF_MEAN|4.639||0.5736|TWO_SIDED|90.0|-0.0507|0.103|||Mixed Models Analysis|||READ\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1030|-0.05070|0.5736
73984592|NCT04748445|147513841|OTHER||Slope|-0.07305|STANDARD_ERROR_OF_MEAN|4.267||0.0894|TWO_SIDED|90.0|-0.1438|-0.002335|||Mixed Models Analysis|||READ\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.002335|-0.1438|0.0894
73984593|NCT04748445|147513841|OTHER||Slope|-2.369|STANDARD_ERROR_OF_MEAN|4.428||0.5936|TWO_SIDED|90.0|-9.706|4.968|||Mixed Models Analysis|||READ\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||4.968|-9.706|0.5936
73984594|NCT04748445|147513841|OTHER||Slope|-0.07377|STANDARD_ERROR_OF_MEAN|3.339||0.029|TWO_SIDED|90.0|-0.1291|-0.01844|||Mixed Models Analysis|||READ\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.01844|-0.1291|0.0290
73984595|NCT04748445|147513841|OTHER||Slope|0.008703|STANDARD_ERROR_OF_MEAN|3.665||0.8127|TWO_SIDED|90.0|-0.05203|0.06944|||Mixed Models Analysis|||READ\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06944|-0.05203|0.8127
73984596|NCT04748445|147513841|OTHER||Slope|-0.07414|STANDARD_ERROR_OF_MEAN|3.294||0.0262|TWO_SIDED|90.0|-0.1287|-0.01955|||Mixed Models Analysis|||READ\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.01955|-0.1287|0.0262
73984597|NCT04748445|147513841|OTHER||Slope|2.929|STANDARD_ERROR_OF_MEAN|2.705||0.2809|TWO_SIDED|90.0|-1.553|7.412|||Mixed Models Analysis|||READ\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||7.412|-1.553|0.2809
73874723|NCT04950465|147291179|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.115||0.7645|TWO_SIDED|95.0|-0.26|0.19|||ANCOVA|||||0.19|-0.26|0.7645
73874724|NCT04950465|147291180|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.114||0.9728|TWO_SIDED|95.0|-0.23|0.22|||ANCOVA|||Week 4||0.22|-0.23|0.9728
73874725|NCT04950465|147291180|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.14||0.2968|TWO_SIDED|95.0|-0.13|0.42|||ANCOVA|||Week 8||0.42|-0.13|0.2968
73874726|NCT04950465|147291181|SUPERIORITY|||||||0.1682|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 4||||0.1682
73984598|NCT04748445|147513841|OTHER||Slope|-2.717|STANDARD_ERROR_OF_MEAN|6.612|<|0.0001|TWO_SIDED|90.0|-3.812|-1.621|||Mixed Models Analysis|||READ\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2).||-1.621|-3.812|<.0001
73984599|NCT04748445|147513841|OTHER||Slope|-0.05798|STANDARD_ERROR_OF_MEAN|2.961||0.0524|TWO_SIDED|90.0|-0.107|-0.008915|||Mixed Models Analysis|||READ\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.008915|-0.1070|0.0524
73984600|NCT04748445|147513841|OTHER||Slope|-1.008|STANDARD_ERROR_OF_MEAN|1.778||0.5716|TWO_SIDED|90.0|-3.955|1.938|||Mixed Models Analysis|||READ\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||1.938|-3.955|0.5716
73984601|NCT04748445|147513841|OTHER||Slope|-0.0223|STANDARD_ERROR_OF_MEAN|1.193||0.064|TWO_SIDED|90.0|-0.04208|-0.002526|||Mixed Models Analysis|||READ\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.002526|-0.04208|0.0640
73984602|NCT04748445|147513841|OTHER||Slope|-1.336|STANDARD_ERROR_OF_MEAN|1.176||0.2584|TWO_SIDED|90.0|-3.285|6.138|||Mixed Models Analysis|||READ\_MFCC std 05 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-2. For upper limit it was 10\^-3).||6.138|-3.285|0.2584
73984603|NCT04748445|147513841|OTHER||Slope|-0.006497|STANDARD_ERROR_OF_MEAN|1.413||0.6465|TWO_SIDED|90.0|-0.02992|0.01692|||Mixed Models Analysis|||READ\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.01692|-0.02992|0.6465
73874727|NCT04950465|147291181|SUPERIORITY|||||||0.3937|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 8||||0.3937
73874728|NCT02366195|147291182|OTHER|||||||0.387|||||||Regression, Logistic|||||||0.387
73874729|NCT02366195|147291183|OTHER|Primary completion data.||||||0.056|||||||Regression, Logistic|||||||0.056
73874730|NCT02366195|147291183|OTHER|Final analysis data.||||||0.222|||||||Regression, Logistic|||||||0.222
73874731|NCT02366195|147291184|OTHER|Primary completion data||||||0.335|||||||Cox proportional hazards|||||||0.335
73984604|NCT04748445|147513841|OTHER||Slope|-1.213|STANDARD_ERROR_OF_MEAN|7.7||0.1177|TWO_SIDED|90.0|-2.489|6.297|||Mixed Models Analysis|||READ\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3 and for upper limit it was 10\^-4).||6.297|-2.489|0.1177
73984605|NCT04748445|147513841|OTHER||Slope|-0.007959|STANDARD_ERROR_OF_MEAN|9.743||0.4155|TWO_SIDED|90.0|-0.02411|0.008187|||Mixed Models Analysis|||READ\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.008187|-0.02411|0.4155
74034061|NCT03342469|147620948|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"inattentive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
74039536|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0974|TWO_SIDED|95.0|0.94|1.99|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|0.94|0.0974
73984606|NCT04748445|147513841|OTHER||Slope|-0.004137|STANDARD_ERROR_OF_MEAN|8.017||0.6067|TWO_SIDED|90.0|-0.01742|0.009148|||Mixed Models Analysis|||READ\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.009148|-0.01742|0.6067
73984607|NCT04748445|147513841|OTHER||Slope|0.000376|STANDARD_ERROR_OF_MEAN|7.531||0.9603|TWO_SIDED|90.0|-0.0121|0.01286|||Mixed Models Analysis|||READ\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01286|-0.01210|0.9603
73984608|NCT04748445|147513841|OTHER||Slope|-0.002185|STANDARD_ERROR_OF_MEAN|5.703||0.7022|TWO_SIDED|90.0|-0.01164|0.007265|||Mixed Models Analysis|||READ\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.007265|-0.01164|0.7022
73874732|NCT02366195|147291184|OTHER|Final analysis data||||||0.597|||||||Cox proportional hazards|||||||0.597
73874733|NCT02366195|147291185|OTHER|Primary completion||||||0.82|||||||Fisher's Z transformation|||||||0.82
73874734|NCT02366195|147291185|OTHER|Final analysis data||||||0.9|||||||Fisher's Z transformation|||||||0.90
73874735|NCT02366195|147291186|OTHER|Primary completion data||||||0.66|||||||Regression, Logistic|||||||0.660
73874736|NCT02366195|147291186|OTHER|Final analysis data||||||0.881|||||||Regression, Logistic|||||||0.881
73874737|NCT02366195|147291187|OTHER|Primary completion data||||||0.974|||||||Regression, Logistic|||||||0.974
73874738|NCT02366195|147291187|OTHER|Final analysis data||||||0.612|||||||Regression, Logistic|||||||0.612
73874739|NCT02366195|147291188|OTHER|Primary completion data||||||0.626|||||||Cox proportional hazards|||||||0.626
73874740|NCT02366195|147291188|OTHER|Final analysis data||||||0.579|||||||Cox proportional hazards|||||||0.579
73874741|NCT02366195|147291189|OTHER|Primary completion data||||||0.18|||||||Pearson's correlation coefficient|||||||0.18
73874742|NCT02366195|147291189|OTHER|Final analysis data||||||0.14|||||||Pearson's correlation coefficient|||||||0.14
73874743|NCT01379183|147291204|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73874744|NCT01379183|147291205|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANCOVA|||||||0.27
73874745|NCT01379183|147291206|SUPERIORITY_OR_OTHER|||||||0.96|||||||ANCOVA|||||||0.96
73874746|NCT01379183|147291207|SUPERIORITY_OR_OTHER|||||||0.71|||||||ANCOVA|||||||0.71
73874747|NCT01379183|147291208|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANCOVA|||||||0.37
73874748|NCT01379183|147291209|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANCOVA|||||||0.12
73874749|NCT02562716|147291213|SUPERIORITY|||||||0.15|||||||Log Rank|||For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.||||.15
73874750|NCT02562716|147291213|SUPERIORITY|||||||0.14|||||||Log Rank|||For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.||||.14
73874751|NCT01425801|147291224|SUPERIORITY_OR_OTHER||Least Squares Mean DIfference|0.405|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.353|0.458|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.458|0.353|<0.0001
73874752|NCT01425801|147291224|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.371|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.318|0.424|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.424|0.318|<0.0001
73874753|NCT01425801|147291224|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.322|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.269|0.375|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.375|0.269|<0.0001
73874754|NCT01425801|147291224|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.274|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.221|0.327|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.327|0.221|<0.0001
73984609|NCT04748445|147513841|OTHER||Slope|0.007716|STANDARD_ERROR_OF_MEAN|5.746||0.1818|TWO_SIDED|90.0|-0.001806|0.01724|||Mixed Models Analysis|||READ\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01724|-0.001806|0.1818
73874755|NCT00731679|147291252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.01
73874756|NCT00731679|147291253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.005
73874757|NCT01598922|147291254|OTHER|Intent-to-treat (ITT) analyses following multiple imputation. Generalized Linear Models (GENLIN) predicting post-treatment HRSD scores in the imputed dataset. Covarying for pre-treatment HRSD scores, age and sex.|Odds Ratio (OR)|6.11|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|2.814|9.403|||GENLIN|||||9.403|2.814|<0.0001
73874758|NCT01598922|147291255|OTHER||Cohen's d measure of effect size|-0.79||||0.024|TWO_SIDED|95.0|-1.25|-0.32||Hierarchical Linear Modeling (HLM) was applied to PHQ-9 data, adjusting for baseline PHQ-9 score. Group x Time interactions tested for between-group differences in slope of improvement of PHQ-9 scores.|hierarchical linear modeling|Age and sex were covariates. Cohen's d effect sizes are reported.||||-0.32|-1.25|.024
73874759|NCT01598922|147291256|OTHER|Hierarchical Linear Modeling (HLM) was applied to K-10 data, adjusting for baseline K-10 score. Group x Time interactions tested for between-group differences in slope of improvement of K-10 scores.|Cohen's d measure of effect size|-0.95||||0.003|TWO_SIDED|95.0|-1.42|-0.48|||HLM|||The Kessler Psychological Distress Scale (K-10) is a 10-item scale with total scores that can range from 0 to 50. Higher scores represent worse (more severe) psychological distress.||-0.48|-1.42|.003
73956146|NCT02219490|147447989|SUPERIORITY||Cox Proportional Hazard Ratio|0.126|||<|0.001|TWO_SIDED|95.0|0.044|0.358|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.358|0.044|<0.001
73956147|NCT02219490|147447990|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
73956148|NCT02219490|147447990|SUPERIORITY||Cox Proportional Hazard Ratio|0.031||||0.007|TWO_SIDED|95.0|0.003|0.38|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.380|0.003|0.007
73956149|NCT02219490|147447991|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
73956150|NCT02219490|147447991|SUPERIORITY||Cox Proportional Hazard Ratio|0.038|||<|0.001|TWO_SIDED|95.0|0.009|0.156|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.156|0.009|<0.001
73956151|NCT02219490|147447992|SUPERIORITY|||||||0.86|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.860
73956152|NCT02219490|147447992|SUPERIORITY|||||||0.997||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.997
73956153|NCT02219490|147447993|SUPERIORITY|||||||0.608|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.608
73956154|NCT02219490|147447993|SUPERIORITY|||||||0.992||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.992
73956155|NCT02219490|147447994|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
73984610|NCT04748445|147513841|OTHER||Slope|-0.004019|STANDARD_ERROR_OF_MEAN|6.419||0.5324|TWO_SIDED|90.0|-0.01466|0.006618|||Mixed Models Analysis|||READ\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.006618|-0.01466|0.5324
73874760|NCT04739436|147291310|SUPERIORITY||Slope|5.29||||0.003|TWO_SIDED|95.0|1.8|8.79||Multiple comparisons were not conducted, so no adjustment of the p-value was necessary.|Regression, Linear|||A linear regression model was fit with outcome change in APHAB score between 3 months and baseline, predictor hearing aid fitting group (reference=bilateral), and covariate clinical site.||8.79|1.80|0.003
73874761|NCT04739436|147291311|SUPERIORITY|||||||0.584||||||No adjustments for multiple comparisons were done.|Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, what proportion of the time do you wear your hearing aid?||||0.584
73984611|NCT04748445|147513841|OTHER||Slope|0.005103|STANDARD_ERROR_OF_MEAN|2.737||0.8524|TWO_SIDED|90.0|-0.04025|0.05046|||Mixed Models Analysis|||READ\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.05046|-0.04025|0.8524
73984612|NCT04748445|147513842|OTHER||Slope|2.975|STANDARD_ERROR_OF_MEAN|3.383||0.3809|TWO_SIDED|90.0|-2.631|8.58|||Mixed Models Analysis|||EE\_Coefficient of Variation F0 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4.||8.580|-2.631|0.3809
73984613|NCT04748445|147513842|OTHER||Slope|-0.005601|STANDARD_ERROR_OF_MEAN|2.751||0.0438|TWO_SIDED|90.0|-0.01016|-0.001043|||Mixed Models Analysis|||EE\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3.||-0.001043|-0.01016|0.0438
74039537|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0806|TWO_SIDED|95.0|0.92|4.08|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.08|0.92|0.0806
73874762|NCT04739436|147291311|SUPERIORITY|||||||0.233|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, how much does your hearing aid help you?||||0.233
73874763|NCT04739436|147291311|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, with your hearing aid, how much difficulty do you now have?||||0.010
73956156|NCT02219490|147447994|SUPERIORITY||Cox Proportional Hazard Ratio|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.313|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.313|0.057|<0.001
73956157|NCT02219490|147447995|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.7||0.151|TWO_SIDED|95.0|-0.37|2.37|||ANCOVA||Difference = with SVR12 minus without SVR12|"Final Treatment Visit~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||2.37|-0.37|0.151
73956158|NCT02219490|147447995|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.78||0.878|TWO_SIDED|95.0|-1.64|1.4|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 12~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||1.4|-1.64|0.878
73956159|NCT02219490|147447995|SUPERIORITY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.72|=|0.199|TWO_SIDED|95.0|-2.33|0.48|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 24~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||0.48|-2.33|=0.199
73956160|NCT02219490|147447995|SUPERIORITY||LS Mean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.93||0.021|TWO_SIDED|95.0|-4.0|-0.33|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 52~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.33|-4|0.021
73956161|NCT02219490|147447995|SUPERIORITY||LS Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|0.89||0.006|TWO_SIDED|95.0|-4.22|-0.71|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 104~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.71|-4.22|0.006
73956162|NCT02219490|147447995|SUPERIORITY||LS Mean Difference|-2.58|STANDARD_ERROR_OF_MEAN|0.92||0.005|TWO_SIDED|95.0|-4.38|-0.79|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 156~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.79|-4.38|0.005
73956163|NCT02219490|147447995|SUPERIORITY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|1.0||0.172|TWO_SIDED|95.0|-3.32|0.59|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 208~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||0.59|-3.32|0.172
73984614|NCT04748445|147513842|OTHER||Slope|4.12|STANDARD_ERROR_OF_MEAN|1.464||0.0057|TWO_SIDED|90.0|1.694|6.546|||Mixed Models Analysis|||EE\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3.||6.546|1.694|0.0057
73984615|NCT04748445|147513842|OTHER||Slope|-3.067|STANDARD_ERROR_OF_MEAN|1.053||0.0042|TWO_SIDED|90.0|-4.811|-1.323|||Mixed Models Analysis|||EE\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3.||-1.323|-4.811|0.0042
73984616|NCT04748445|147513842|OTHER||Slope|2.78|STANDARD_ERROR_OF_MEAN|9.751||0.0051|TWO_SIDED|90.0|1.164|4.396|||Mixed Models Analysis|||EE\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-3. For dispersion value it was 10\^-4).||4.396|1.164|0.0051
73984617|NCT04748445|147513842|OTHER||Slope|-1.324|STANDARD_ERROR_OF_MEAN|8.289||0.1128|TWO_SIDED|90.0|-2.698|4.973|||Mixed Models Analysis|||EE\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-3. For upper limit it was 10\^-5 and for dispersion value it was 10\^-4).||4.973|-2.698|0.1128
73984618|NCT04748445|147513842|OTHER||Slope|-0.0002606|STANDARD_ERROR_OF_MEAN|9.707||0.7888|TWO_SIDED|90.0|-0.001869|0.001348|||Mixed Models Analysis|||EE\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001348|-0.001869|0.7888
73984619|NCT04748445|147513842|OTHER||Slope|-0.0005071|STANDARD_ERROR_OF_MEAN|7.593||0.5055|TWO_SIDED|90.0|-0.001765|0.0007512|||Mixed Models Analysis|||EE\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007512|-0.001765|0.5055
73984620|NCT04748445|147513842|OTHER||Slope|0.0003067|STANDARD_ERROR_OF_MEAN|6.273||0.6257|TWO_SIDED|90.0|-0.0007328|0.001346|||Mixed Models Analysis|||EE\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001346|-0.0007328|0.6257
73984621|NCT04748445|147513842|OTHER||Slope|-0.001649|STANDARD_ERROR_OF_MEAN|7.998||0.0413|TWO_SIDED|90.0|-0.002974|-0.0003238|||Mixed Models Analysis|||EE\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0003238|-0.002974|0.0413
74034062|NCT03342469|147620948|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Hyperactive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
74034063|NCT03342469|147620948|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in total ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
74034064|NCT05515601|147620956|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.986|||||TWO_SIDED|90.0|0.929|1.05||||||||1.05|0.929|
74034065|NCT05515601|147620957|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|1.01|||||TWO_SIDED|90.0|0.948|1.08||||||||1.08|0.948|
74034066|NCT05515601|147620958|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability|Ratio of Geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||||1.09|0.960|
74039538|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0407|TWO_SIDED|95.0|1.03|4.47|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.47|1.03|0.0407
73984622|NCT04748445|147513842|OTHER||Slope|0.0008236|STANDARD_ERROR_OF_MEAN|7.053||0.2451|TWO_SIDED|90.0|-0.0003452|0.001992|||Mixed Models Analysis|||EE\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001992|-0.0003452|0.2451
73984623|NCT04748445|147513842|OTHER||Slope|-0.000292|STANDARD_ERROR_OF_MEAN|6.839||0.6702|TWO_SIDED|90.0|-0.001425|0.0008413|||Mixed Models Analysis|||EE\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0008413|-0.001425|0.6702
73984624|NCT04748445|147513842|OTHER||Slope|-0.0003363|STANDARD_ERROR_OF_MEAN|6.312||0.5951|TWO_SIDED|90.0|-0.001382|0.0007097|||Mixed Models Analysis|||EE\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007097|-0.001382|0.5951
73984625|NCT04748445|147513842|OTHER||Slope|0.0007281|STANDARD_ERROR_OF_MEAN|5.677||0.202|TWO_SIDED|90.0|-0.0002126|0.001669|||Mixed Models Analysis|||EE\_MFCC 1st order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001669|-0.0002126|0.2020
73984626|NCT04748445|147513842|OTHER||Slope|0.0005153|STANDARD_ERROR_OF_MEAN|1.523||0.7356|TWO_SIDED|90.0|-0.002008|0.003038|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003038|-0.002008|0.7356
73984627|NCT04748445|147513842|OTHER||Slope|-0.00133|STANDARD_ERROR_OF_MEAN|6.782||0.0522|TWO_SIDED|90.0|-0.002453|-0.0002057|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002057|-0.002453|0.0522
74089686|NCT00700817|147732158|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6||||0.0001||95.0|-0.77|-0.43||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority.||-0.43|-0.77|0.0001
73874764|NCT04739436|147291311|SUPERIORITY|||||||0.129|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: For this situation, how satisfied are you with your hearing aid?||||0.129
73984628|NCT04748445|147513842|OTHER||Slope|-0.000156|STANDARD_ERROR_OF_MEAN|6.763||0.818|TWO_SIDED|90.0|-0.001277|0.0009647|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0009647|-0.001277|0.8180
73984629|NCT04748445|147513842|OTHER||Slope|-0.0000971|STANDARD_ERROR_OF_MEAN|6.18||0.8754|TWO_SIDED|90.0|-0.001121|0.000927|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4.||0.0009270|-0.001121|0.8754
73984630|NCT04748445|147513842|OTHER||Slope|0.000452|STANDARD_ERROR_OF_MEAN|5.576||0.4192|TWO_SIDED|90.0|-0.0004721|0.001376|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001376|-0.0004721|0.4192
73984631|NCT04748445|147513842|OTHER||Slope|-0.0001528|STANDARD_ERROR_OF_MEAN|5.586||0.7849|TWO_SIDED|90.0|-0.001079|0.0007729|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007729|-0.001079|0.7849
73984632|NCT04748445|147513842|OTHER||Slope|-5.254|STANDARD_ERROR_OF_MEAN|4.217||0.901|TWO_SIDED|90.0|-7.513|6.463|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-4. For estimated value it was 10\^-5).||6.463|-7.513|0.9010
73984633|NCT04748445|147513842|OTHER||Slope|-0.0004591|STANDARD_ERROR_OF_MEAN|3.83||0.2329|TWO_SIDED|90.0|-0.001094|0.0001755|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0001755|-0.001094|0.2329
73984634|NCT04748445|147513842|OTHER||Slope|0.0007046|STANDARD_ERROR_OF_MEAN|3.687||0.0583|TWO_SIDED|90.0|0.00009366|0.001315|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001315|0.00009366|0.0583
73984635|NCT04748445|147513842|OTHER||Slope|-1.564|STANDARD_ERROR_OF_MEAN|3.606||0.6654|TWO_SIDED|90.0|-7.54|4.413|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||4.413|-7.540|0.6654
73984636|NCT04748445|147513842|OTHER||Slope|0.00006573|STANDARD_ERROR_OF_MEAN|2.81||0.8154|TWO_SIDED|90.0|-0.0003998|0.0005313|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005313|-0.0003998|0.8154
73984637|NCT04748445|147513842|OTHER||Slope|-0.0004071|STANDARD_ERROR_OF_MEAN|3.664||0.2687|TWO_SIDED|90.0|-0.001014|0.0002001|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002001|-0.001014|0.2687
73984638|NCT04748445|147513842|OTHER||Slope|2.799|STANDARD_ERROR_OF_MEAN|3.317||0.4005|TWO_SIDED|90.0|-2.698|8.296|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.296|-2.698|0.4005
73984639|NCT04748445|147513842|OTHER||Slope|1.123|STANDARD_ERROR_OF_MEAN|1.676||0.504|TWO_SIDED|90.0|-1.654|3.901|||Mixed Models Analysis|||MM\_Coefficient of Variation F0 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||3.901|-1.654|0.5040
73984640|NCT04748445|147513842|OTHER||Slope|0.00007586|STANDARD_ERROR_OF_MEAN|2.882||0.979|TWO_SIDED|90.0|-0.004701|0.004852|||Mixed Models Analysis|||MM\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.004852|-0.004701|0.9790
73984641|NCT04748445|147513842|OTHER||Slope|0.0008249|STANDARD_ERROR_OF_MEAN|1.815||0.6503|TWO_SIDED|90.0|-0.002183|0.003833|||Mixed Models Analysis|||MM\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003833|-0.002183|0.6503
73874765|NCT04739436|147291312|SUPERIORITY|||||||0.946|||||||Kruskal-Wallis|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change from baseline to 3 months in the co-located BKB SIN test scores between the groups.||||0.946
73874766|NCT04739436|147291313|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|No adjustments for multiple comparisons were done.||The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recognition scores between the groups.||||0.490
73984642|NCT04748445|147513842|OTHER||Slope|-1.188|STANDARD_ERROR_OF_MEAN|1.322||0.3705|TWO_SIDED|90.0|-3.379|1.003|||Mixed Models Analysis|||MM\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3).||1.003|-3.379|0.3705
73984643|NCT04748445|147513842|OTHER||Slope|-0.0007258|STANDARD_ERROR_OF_MEAN|1.101||0.5111|TWO_SIDED|90.0|-0.002551|0.001099|||Mixed Models Analysis|||MM\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.001099|-0.002551|0.5111
73984644|NCT04748445|147513842|OTHER||Slope|-0.001326|STANDARD_ERROR_OF_MEAN|7.555||0.0816|TWO_SIDED|90.0|-0.002578|-0.0000744|||Mixed Models Analysis|||MM\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0000744|-0.002578|0.0816
73874767|NCT04739436|147291313|SUPERIORITY|||||||0.323||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recall scores between the groups.||||0.323
73874768|NCT04739436|147291314|SUPERIORITY|||||||0.933||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the SADL scores between the groups at 3 months.||||0.933
73874769|NCT04739436|147291314|SUPERIORITY|||||||0.929||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the SADL scores between the groups at 6 months.||||0.929
73984645|NCT04748445|147513842|OTHER||Slope|0.0005502|STANDARD_ERROR_OF_MEAN|1.056||0.6034|TWO_SIDED|90.0|-0.0012|0.002301|||Mixed Models Analysis|||MM\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.002301|-0.001200|0.6034
73984646|NCT04748445|147513842|OTHER||Slope|-0.0004691|STANDARD_ERROR_OF_MEAN|7.305||0.522|TWO_SIDED|90.0|-0.00168|0.0007415|||Mixed Models Analysis|||MM\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007415|-0.001680|0.5220
73984647|NCT04748445|147513842|OTHER||Slope|-0.00153|STANDARD_ERROR_OF_MEAN|7.82||0.0526|TWO_SIDED|90.0|-0.002826|-0.0002344|||Mixed Models Analysis|||MM\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002344|-0.002826|0.0526
73984648|NCT04748445|147513842|OTHER||Slope|0.0004166|STANDARD_ERROR_OF_MEAN|7.294||0.5689|TWO_SIDED|90.0|-0.000792|0.001625|||Mixed Models Analysis|||MM\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001625|-0.0007920|0.5689
73984649|NCT04748445|147513842|OTHER||Slope|-0.002112|STANDARD_ERROR_OF_MEAN|7.299||0.0045|TWO_SIDED|90.0|-0.003321|-0.000902|||Mixed Models Analysis|||MM\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0009020|-0.003321|0.0045
73984650|NCT04748445|147513842|OTHER||Slope|-0.0007706|STANDARD_ERROR_OF_MEAN|7.494||0.3058|TWO_SIDED|90.0|-0.002013|0.0004713|||Mixed Models Analysis|||MM\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0004713|-0.002013|0.3058
73984651|NCT04748445|147513842|OTHER||Slope|0.0002388|STANDARD_ERROR_OF_MEAN|6.494||0.7137|TWO_SIDED|90.0|-0.0008374|0.001315|||Mixed Models Analysis|||MM\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001315|-0.0008374|0.7137
73984652|NCT04748445|147513842|OTHER||Slope|0.0002121|STANDARD_ERROR_OF_MEAN|6.877||0.7583|TWO_SIDED|90.0|-0.0009275|0.001352|||Mixed Models Analysis|||MM\_MFCC 1st order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001352|-0.0009275|0.7583
73984653|NCT04748445|147513842|OTHER||Slope|-2.784|STANDARD_ERROR_OF_MEAN|1.667||0.0974|TWO_SIDED|90.0|-5.547|-2.155|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit it was 10\^-5. For lower limit, estimated value and dispersion value it was 10\^-3).||-2.155|-5.547|0.0974
73984654|NCT04748445|147513842|OTHER||Slope|-1.368|STANDARD_ERROR_OF_MEAN|9.117||0.881|TWO_SIDED|90.0|-1.648|1.374|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and lower limit it was 10\^-3. For estimated value and dispersion value it was 10\^-4).||1.374|-1.648|0.8810
73984655|NCT04748445|147513842|OTHER||Slope|-0.001551|STANDARD_ERROR_OF_MEAN|6.294||0.0151|TWO_SIDED|90.0|-0.002594|-0.0005077|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0005077|-0.002594|0.0151
73874770|NCT04739436|147291316|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||The null hypothesis is there is no difference in the change from baseline to 3 months in SSQ scores between the groups.||||0.015
73874771|NCT04739436|147291316|SUPERIORITY|||||||0.886|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change from baseline to 6 months in SSQ scores between the groups.||||0.886
73874772|NCT04739436|147291317|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the right ear.||||0.137
73874773|NCT04739436|147291317|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the left ear.||||0.612
73874774|NCT04739436|147291319|SUPERIORITY|||||||0.108|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the IOI-HA total score between the groups at 3 months.||||0.108
73874775|NCT04739436|147291319|SUPERIORITY|||||||0.988||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the IOI-HA total score between the groups at 6 months.||||0.988
73874776|NCT04739436|147291322|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change in APHAB score from baseline to 6 months between the groups.||||0.264
73984656|NCT04748445|147513842|OTHER||Slope|0.00184|STANDARD_ERROR_OF_MEAN|7.343||0.0135|TWO_SIDED|90.0|0.0006233|0.003057|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.003057|0.0006233|0.0135
73984657|NCT04748445|147513842|OTHER||Slope|0.00129|STANDARD_ERROR_OF_MEAN|5.029||0.0115|TWO_SIDED|90.0|0.0004563|0.002123|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002123|0.0004563|0.0115
73984658|NCT04748445|147513842|OTHER||Slope|-0.0001473|STANDARD_ERROR_OF_MEAN|5.891||0.8029|TWO_SIDED|90.0|-0.001123|0.0008288|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0008288|-0.001123|0.8029
73874777|NCT02052752|147291362|SUPERIORITY_OR_OTHER|||||||0.283||95.0|||||ANCOVA|||The ANCOVA results for the primary endpoint with treatment group as a main effect and average baseline value as a covariate showed no statistically significant differences in the percentage change from baseline in swelling of the target lesions between the 3% BPO group and the vehicle control group at Day 4 for the ITT population||||0.283
73874778|NCT02777827|147291384|SUPERIORITY||Least square mean|0.2221|STANDARD_ERROR_OF_MEAN|0.0453|<|0.0001|TWO_SIDED|95.0|0.1324|0.3118|||ANCOVA|||||0.3118|0.1324|<0.0001
73984659|NCT04748445|147513842|OTHER||Slope|-0.0005556|STANDARD_ERROR_OF_MEAN|4.647||0.2342|TWO_SIDED|90.0|-0.001326|0.0002146|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002146|-0.001326|0.2342
73984660|NCT04748445|147513842|OTHER||Slope|0.001128|STANDARD_ERROR_OF_MEAN|5.339||0.0366|TWO_SIDED|90.0|0.0002436|0.002013|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002013|0.0002436|0.0366
73984661|NCT04748445|147513842|OTHER||Slope|-0.0003297|STANDARD_ERROR_OF_MEAN|5.134||0.522|TWO_SIDED|90.0|-0.00118|0.0005212|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005212|-0.001180|0.5220
73984662|NCT04748445|147513842|OTHER||Slope|-2.104|STANDARD_ERROR_OF_MEAN|3.528||0.552|TWO_SIDED|90.0|-7.95|3.742|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||3.742|-7.950|0.5520
73984663|NCT04748445|147513842|OTHER||Slope|0.0005126|STANDARD_ERROR_OF_MEAN|4.289||0.2343|TWO_SIDED|90.0|-0.0001981|0.001223|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For ldispersion value it was 10\^-4).||0.001223|-0.0001981|0.2343
73984664|NCT04748445|147513842|OTHER||Slope|2.703|STANDARD_ERROR_OF_MEAN|4.094||0.5103|TWO_SIDED|90.0|-4.081|9.487|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||9.487|-4.081|0.5103
73984665|NCT04748445|147513842|OTHER||Slope|-0.000202|STANDARD_ERROR_OF_MEAN|5.334||0.7056|TWO_SIDED|90.0|-0.001086|0.0006819|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0006819|-0.001086|0.7056
73984666|NCT04748445|147513842|OTHER||Slope|-2.66|STANDARD_ERROR_OF_MEAN|9.22||0.0046|TWO_SIDED|90.0|-4.188|-1.132|||Mixed Models Analysis|||READ\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||-1.132|-4.188|0.0046
73984667|NCT04748445|147513842|OTHER||Slope|0.000649|STANDARD_ERROR_OF_MEAN|4.448||0.1471|TWO_SIDED|90.0|-0.0000881|0.001386|||Mixed Models Analysis|||READ\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001386|-0.0000881|0.1471
73984668|NCT04748445|147513842|OTHER||Slope|1.355|STANDARD_ERROR_OF_MEAN|3.323||0.6842|TWO_SIDED|90.0|-4.152|6.862|||Mixed Models Analysis|||READ\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||6.862|-4.152|0.6842
73984669|NCT04748445|147513842|OTHER||Slope|0.00007664|STANDARD_ERROR_OF_MEAN|2.574||0.7664|TWO_SIDED|90.0|-0.0003499|0.0005032|||Mixed Models Analysis|||READ\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005032|-0.0003499|0.7664
73874779|NCT02777827|147291384|SUPERIORITY||Least Square Mean|0.4042|STANDARD_ERROR_OF_MEAN|0.0453|<|0.0001|TWO_SIDED|95.0|0.3146|0.4938|||ANCOVA|||||0.4938|0.3146|<0.0001
73874780|NCT02777827|147291384|SUPERIORITY||Least Square Mean|0.1056|STANDARD_ERROR_OF_MEAN|0.0451||0.0207|TWO_SIDED|95.0|0.0164|0.1949|||ANCOVA|||||0.1949|0.0164|0.0207
73984670|NCT04748445|147513842|OTHER||Slope|-1.708|STANDARD_ERROR_OF_MEAN|2.028||0.4015|TWO_SIDED|90.0|-5.069|1.654|||Mixed Models Analysis|||READ\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||1.654|-5.069|0.4015
73874781|NCT02777827|147291384|SUPERIORITY||Least Square Mean|0.1701|STANDARD_ERROR_OF_MEAN|0.045||0.0002|TWO_SIDED|95.0|0.081|0.2592|||ANCOVA|||||0.2592|0.0810|0.0002
73984671|NCT04748445|147513842|OTHER||Slope|2.51|STANDARD_ERROR_OF_MEAN|1.904||0.1897|TWO_SIDED|90.0|-6.446|5.665|||Mixed Models Analysis|||READ\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||5.665|-6.446|0.1897
73874782|NCT02777827|147291384|SUPERIORITY||Least Square Mean|0.4062|STANDARD_ERROR_OF_MEAN|0.0451|<|0.0001|TWO_SIDED|95.0|0.317|0.4955|||ANCOVA|||||0.4955|0.3170|<0.0001
73874783|NCT01604291|147291417|OTHER|||||||0.9109||||||The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|Chi-squared|||Correlation between SVR 24 and Gender||||0.9109
73874784|NCT01604291|147291417|OTHER|||||||0.1163||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Age||||0.1163
73874785|NCT01604291|147291417|OTHER|||||||0.9269||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Height||||0.9269
73984672|NCT04748445|147513842|OTHER||Slope|2.393|STANDARD_ERROR_OF_MEAN|1.627||0.1439|TWO_SIDED|90.0|-3.035|5.09|||Mixed Models Analysis|||READ\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||5.090|-3.035|0.1439
73984673|NCT04748445|147513842|OTHER||Slope|4.111|STANDARD_ERROR_OF_MEAN|1.553||0.0092|TWO_SIDED|90.0|1.537|6.685|||Mixed Models Analysis|||READ\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||6.685|1.537|0.0092
73984674|NCT04748445|147513842|OTHER||Slope|-0.0000415|STANDARD_ERROR_OF_MEAN|1.134||0.715|TWO_SIDED|90.0|-0.0002294|0.0001464|||Mixed Models Analysis|||READ\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0001464|-0.0002294|0.7150
73984675|NCT04748445|147513842|OTHER||Slope|1.593|STANDARD_ERROR_OF_MEAN|1.291||0.2194|TWO_SIDED|90.0|-5.457|3.731|||Mixed Models Analysis|||READ\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||3.731|-5.457|0.2194
73984676|NCT04748445|147513842|OTHER||Slope|0.0001893|STANDARD_ERROR_OF_MEAN|9.442||0.0471|TWO_SIDED|90.0|0.00003283|0.0003458|||Mixed Models Analysis|||READ\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0003458|0.00003283|0.0471
73984677|NCT04748445|147513842|OTHER||Slope|0.000138|STANDARD_ERROR_OF_MEAN|6.614||0.039|TWO_SIDED|90.0|0.0000284|0.0002476|||Mixed Models Analysis|||READ\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0002476|0.00002840|0.0390
73984678|NCT04748445|147513842|OTHER||Slope|1.166|STANDARD_ERROR_OF_MEAN|1.04||0.2645|TWO_SIDED|90.0|-5.579|2.89|||Mixed Models Analysis|||READ\_MFCC 1st order delta 13 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||2.890|-5.579|0.2645
73984679|NCT04748445|147513842|OTHER||Slope|-0.00119|STANDARD_ERROR_OF_MEAN|5.79||0.042|TWO_SIDED|90.0|-0.002149|-0.0002303|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002303|-0.002149|0.0420
73984680|NCT04748445|147513842|OTHER||Slope|-4.504|STANDARD_ERROR_OF_MEAN|3.04||0.141|TWO_SIDED|90.0|-9.542|5.341|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-4. For upper limit it was 10\^-5).||5.341|-9.542|0.1410
73984681|NCT04748445|147513842|OTHER||Slope|2.968|STANDARD_ERROR_OF_MEAN|3.334||0.3751|TWO_SIDED|90.0|-2.557|8.492|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.492|-2.557|0.3751
73984682|NCT04748445|147513842|OTHER||Slope|-0.0000796|STANDARD_ERROR_OF_MEAN|2.101||0.7053|TWO_SIDED|90.0|-0.0004277|0.0002685|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002685|-0.0004277|0.7053
73984683|NCT04748445|147513842|OTHER||Slope|5.075|STANDARD_ERROR_OF_MEAN|1.878||0.0078|TWO_SIDED|90.0|1.964|8.187|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.187|1.964|0.0078
74034067|NCT00777491|147620959|OTHER|There was no formal comparison of the two treatment arms.||||||||||||||||The confidence interval of the rate was calculated by Clopper-Pearson's exact binomial confidence intervals methods with one-sided type I error of 0.1. The study required 32 analyzable patients in each arm, which would warrant a 10% chance of observing a percentage of patients without distant metastasis by 3 years of less than 75% if the true rate was 86%. With the actual number of evaluable patients, the study instead warrants a 13-14% chance.|If the percentage of patients without distant metastasis by 3 years for either arm was greater than or equal to 75%, then it would be strongly considered as a potential arm in a subsequent phase III study, assuming treatment delivery and adverse events (AEs) were acceptable. If both arms met the criteria, then the treatment arm with less toxicity would be chosen.|||
74034068|NCT00777491|147620962|SUPERIORITY||Odds Ratio (OR)|0.493||||0.3|TWO_SIDED|95.0|0.129|1.881||Two-sided significance level of 0.05|Regression, Logistic|Univariate analysis|Reference arm = 5-FU and Cisplatin + BID Irradiation|||1.881|0.129|0.30
73874786|NCT01604291|147291417|OTHER|||||||0.3376||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Weight||||0.3376
73984684|NCT04748445|147513842|OTHER||Slope|-1.88|STANDARD_ERROR_OF_MEAN|1.174||0.1119|TWO_SIDED|90.0|-3.826|6.611|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-4. For upper limit it was 10\^-6).||6.611|-3.826|0.1119
73984685|NCT04748445|147513842|OTHER||Slope|1.667|STANDARD_ERROR_OF_MEAN|1.164||0.1545|TWO_SIDED|90.0|-2.615|3.596|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||3.596|-2.615|0.1545
73984686|NCT04748445|147513842|OTHER||Slope|1.531|STANDARD_ERROR_OF_MEAN|9.552||0.1114|TWO_SIDED|90.0|-5.164|3.114|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-4. For lower limit it was 10\^-6 and for dispersion value it was 10\^-5).||3.114|-5.164|0.1114
74034069|NCT00777491|147620963|SUPERIORITY||Odds Ratio (OR)|1.5||||0.75|TWO_SIDED|95.0|0.426|5.277||Two-sided significance level of 0.05|Regression, Logistic|Univariable analysis|Reference arm = 5-FU and Cisplatin + BID irradiation|||5.277|0.426|0.75
73874787|NCT01604291|147291417|OTHER|||||||0.4618||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Body mass index.||||0.4618
73984687|NCT04748445|147513842|OTHER||Slope|0.0001989|STANDARD_ERROR_OF_MEAN|1.076||0.0668|TWO_SIDED|90.0|0.00002067|0.0003772|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0003772|0.00002067|0.0668
73984688|NCT04748445|147513842|OTHER||Slope|0.00005573|STANDARD_ERROR_OF_MEAN|9.318||0.5509|TWO_SIDED|90.0|-0.0000986|0.0002101|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0002101|-0.0000986|0.5509
73984689|NCT04748445|147513842|OTHER||Slope|0.00001774|STANDARD_ERROR_OF_MEAN|8.677||0.8383|TWO_SIDED|90.0|-0.000126|0.0001615|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0001615|-0.0001260|0.8383
73984690|NCT04748445|147513842|OTHER||Slope|0.00007327|STANDARD_ERROR_OF_MEAN|6.63||0.2713|TWO_SIDED|90.0|-0.0000366|0.0001831|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0001831|-0.0000366|0.2713
73984691|NCT04748445|147513842|OTHER||Slope|0.0001534|STANDARD_ERROR_OF_MEAN|9.067||0.0931|TWO_SIDED|90.0|0.00000317|0.0003037|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0003037|0.00000317|0.0931
73984692|NCT04748445|147513843|OTHER||Slope|-1.931|STANDARD_ERROR_OF_MEAN|3.554||0.5878|TWO_SIDED|90.0|-7.82|3.958|||Mixed Models Analysis|||EE\_Entropy (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3).||3.958|-7.820|0.5878
73984693|NCT04748445|147513843|OTHER||Slope|-1.479|STANDARD_ERROR_OF_MEAN|2.847||0.9587|TWO_SIDED|90.0|-4.866|4.57|||Mixed Models Analysis|||MM\_Entropy (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-4. For dispersion value, lower limit and upper limit it was 10\^-3).||4.570|-4.866|0.9587
73984694|NCT04748445|147513844|OTHER||Slope|-3.262|STANDARD_ERROR_OF_MEAN|4.487||0.9421|TWO_SIDED|90.0|-7.761|7.109|||Mixed Models Analysis|||EE\_Formant 1 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-1. For estimated value it was 10\^-2).||7.109|-7.761|0.9421
73984695|NCT04748445|147513844|OTHER||Slope|-0.06912|STANDARD_ERROR_OF_MEAN|5.997||0.9084|TWO_SIDED|90.0|-1.063|0.9247|||Mixed Models Analysis|||EE\_Formant 1 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||0.9247|-1.063|0.9084
73984696|NCT04748445|147513844|OTHER||Slope|1.985|STANDARD_ERROR_OF_MEAN|1.23||0.8721|TWO_SIDED|90.0|-1.841|2.238|||Mixed Models Analysis|||EE\_Formant 2 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^0. For estimated value it was 10\^-1).||2.238|-1.841|0.8721
73984697|NCT04748445|147513844|OTHER||Slope|0.6573|STANDARD_ERROR_OF_MEAN|2.191||0.7647|TWO_SIDED|90.0|-2.974|4.288|||Mixed Models Analysis|||EE\_Formant 2 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||4.288|-2.974|0.7647
73984698|NCT04748445|147513844|OTHER||Slope|0.6504|STANDARD_ERROR_OF_MEAN|8.958||0.4692|TWO_SIDED|90.0|-0.8341|2.135|||Mixed Models Analysis|||EE\_Formant 3 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||2.135|-0.8341|0.4692
73984699|NCT04748445|147513844|OTHER||Slope|-0.09459|STANDARD_ERROR_OF_MEAN|1.255||0.94|TWO_SIDED|90.0|-2.174|1.985|||Mixed Models Analysis|||EE\_Formant 3 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||1.985|-2.174|0.9400
73984700|NCT04748445|147513844|OTHER||Slope|0.6945|STANDARD_ERROR_OF_MEAN|7.972||0.3853|TWO_SIDED|90.0|-0.6265|2.015|||Mixed Models Analysis|||MM\_Formant 1 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||2.015|-0.6265|0.3853
73984701|NCT04748445|147513844|OTHER||Slope|0.02424|STANDARD_ERROR_OF_MEAN|1.021||0.9811|TWO_SIDED|90.0|-1.667|1.716|||Mixed Models Analysis|||MM\_Formant 1 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||1.716|-1.667|0.9811
73984702|NCT04748445|147513844|OTHER||Slope|-0.9256|STANDARD_ERROR_OF_MEAN|1.083||0.3944|TWO_SIDED|90.0|-2.72|0.869|||Mixed Models Analysis|||MM\_Formant 2 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||0.8690|-2.720|0.3944
73984703|NCT04748445|147513844|OTHER||Slope|0.935|STANDARD_ERROR_OF_MEAN|1.289||0.4696|TWO_SIDED|90.0|-1.201|3.071|||Mixed Models Analysis|||MM\_Formant 2 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||3.071|-1.201|0.4696
73984704|NCT04748445|147513844|OTHER||Slope|2.105|STANDARD_ERROR_OF_MEAN|1.231||0.0896|TWO_SIDED|90.0|0.06596|4.145|||Mixed Models Analysis|||MM\_Formant 3 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||4.145|0.06596|0.0896
73984705|NCT04748445|147513844|OTHER||Slope|1.664|STANDARD_ERROR_OF_MEAN|1.358||0.2227|TWO_SIDED|90.0|-5.864|3.915|||Mixed Models Analysis|||MM\_Formant 3 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^0. For lower limit it was 10\^-1).||3.915|-5.864|0.2227
73984706|NCT04748445|147513845|OTHER||Slope|-4.024|STANDARD_ERROR_OF_MEAN|3.122||0.8977|TWO_SIDED|90.0|-5.577|4.772|||Mixed Models Analysis|||EE\_Voiced Frames (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||4.772|-5.577|0.8977
73984707|NCT04748445|147513845|OTHER||Slope|-0.0006624|STANDARD_ERROR_OF_MEAN|7.961||0.407|TWO_SIDED|90.0|-0.001982|0.0006569|||Mixed Models Analysis|||MM\_Voiced Frames (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0006569|-0.001982|0.4070
74039539|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5966|TWO_SIDED|95.0|0.58|2.58|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.58|0.58|0.5966
73874788|NCT01604291|147291430|OTHER||phi-coefficient|-0.0835||||0.0463|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables|Correlation with dose modification for Peginterferon alfa-2a.||||0.0463
73874789|NCT01604291|147291430|OTHER||phi-coefficient|0.0666||||0.2052|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Ribavirin.||||0.2052
73874790|NCT01604291|147291430|OTHER||phi-coefficient|-0.1672||||0.0033|||||||Fisher Exact|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Telaprevir/boceprevir.||||0.0033
73874791|NCT00330759|147291432|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A synthesis approach was used for a non-inferiority test of the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.84||||0.0007||95.0|0.71|0.98|||Regression, Cox|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy||||0.98|0.71|0.0007
73874792|NCT00330759|147291433|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.06||95.0|0.71|0.98|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy|||0.98|0.71|0.060
73874793|NCT00330759|147291434|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.145||95.0|0.77|1.04|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy|||1.04|0.77|0.145
73874794|NCT03726489|147291441|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.2|||<|0.001|TWO_SIDED|95.0|0.8|13.5||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||13.5|0.8|<0.001
74034070|NCT00088634|147620967|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline BPRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
74034071|NCT00088634|147620968|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline PANSS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
74034072|NCT00088634|147620969|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline CGI-S score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
73874795|NCT03726489|147291441|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|4.2|||<|0.001|TWO_SIDED|95.0|-5.4|13.8||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||13.8|-5.4|<0.001
73874796|NCT03726489|147291441|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.4|||<|0.001|TWO_SIDED|95.0|-2.2|17.0||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||17.0|-2.2|<0.001
73874797|NCT03726489|147291441|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%. The sample size for this subgroup did not meet our a priori sample size required for 80% power.|Risk Difference (RD)|18.7|||<|0.001|TWO_SIDED|95.0|0.8|36.6||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||36.6|0.8|<0.001
73874798|NCT03726489|147291441|OTHER|HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.||||||0.347||||||HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.|Regression, Logistic|We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.||Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.||||0.347
73956164|NCT02219490|147447995|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|1.14||0.322|TWO_SIDED|95.0|-3.35|1.1|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 260~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||1.1|-3.35|0.322
73956165|NCT03879642|147448015|SUPERIORITY||partial eta squared|0.117|||||TWO_SIDED||||||ANOVA|||||||
73956166|NCT03879642|147448016|SUPERIORITY||partial eta squared|0.005|||||TWO_SIDED||||||repeated measures ANOVA|||||||
73956167|NCT02974010|147448027|SUPERIORITY|||||||0.03||||||BDM LS difference overall|Mixed Models Analysis|BDM LS difference overall||||||.03
73956168|NCT00320489|147448028|SUPERIORITY_OR_OTHER|||||||0.612||95.0|||||Log Rank|||||||0.612
74039540|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.59||||0.1492|TWO_SIDED|95.0|0.85|2.96|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.96|0.85|0.1492
74034073|NCT00088634|147620970|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline MADRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
73984708|NCT04748445|147513846|OTHER||Slope|0.0008654|STANDARD_ERROR_OF_MEAN|1.441||0.5491|TWO_SIDED|90.0|-0.001522|0.003253|||Mixed Models Analysis|||EE\_Jitter Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003253|-0.001522|0.5491
73984709|NCT04748445|147513846|OTHER||Slope|-2.206|STANDARD_ERROR_OF_MEAN|3.176||0.9447|TWO_SIDED|90.0|-5.483|5.042|||Mixed Models Analysis|||MM\_Jitter Local (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||5.042|-5.483|0.9447
73984710|NCT04748445|147513847|OTHER||Slope|0.007567|STANDARD_ERROR_OF_MEAN|1.12||0.5004|TWO_SIDED|90.0|-0.01099|0.02612|||Mixed Models Analysis|||EE\_Shimmer Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02612|-0.01099|0.5004
73984711|NCT04748445|147513847|OTHER||Slope|0.00606|STANDARD_ERROR_OF_MEAN|1.101||0.5831|TWO_SIDED|90.0|-0.01219|0.02431|||Mixed Models Analysis|||MM\_Shimmer Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02431|-0.01219|0.5831
73984712|NCT04748445|147513848|OTHER||Slope|2.13|STANDARD_ERROR_OF_MEAN|3.211|<|0.0001|TWO_SIDED|90.0|1.598|2.662|||Mixed Models Analysis|||READ\_Speaking Rate (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||2.662|1.598|<.0001
73984713|NCT01106586|147513856|NON_INFERIORITY_OR_EQUIVALENCE|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA \< 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.0|||||TWO_SIDED|95.2|-1.9|7.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the Stribild group is at least 12% worse than the ATV/r + Truvada group with respect to percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the ATV/r + Truvada Group.||7.8|-1.9|
73984714|NCT00938041|147513870|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.|||40|10|
73984715|NCT00938041|147513870|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with confirmed complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.|||40|10|
73984716|NCT00404547|147513911|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||This is an analysis of the change in Asthma Control Questionnaire (ACQ) after 12 weeks of treatment.||||<0.0001
73984717|NCT03906240|147513926|SUPERIORITY||Cohen's d|1.44|||<|0.001|TWO_SIDED|95.0|1.0|2.49|||t-test, 2 sided|t = 5.78||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||2.49|1.00|<.001
73984718|NCT03906240|147513926|SUPERIORITY||Cohen's d|0.78||||0.002|TWO_SIDED|95.0|0.35|1.38|||t-test, 2 sided|t = 3.48||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.38|0.35|.002
73984719|NCT03906240|147513927|SUPERIORITY||Cohen's d|0.01||||0.957|TWO_SIDED|95.0|-0.45|0.91|||t-test, 2 sided|t = 0.06||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.91|-0.45|.957
73984720|NCT03906240|147513927|SUPERIORITY||Cohen's d|0.51||||0.033|TWO_SIDED|95.0|0.08|1.25|||t-test, 2 sided|t = 2.30||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.25|0.08|.033
73984721|NCT03906240|147513928|SUPERIORITY||Cohen's d|0.71||||0.015|TWO_SIDED|95.0|0.32|1.31|||t-test, 2 sided|t = 2.76||Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.31|0.32|.015
73984722|NCT03906240|147513928|SUPERIORITY||Cohen's d|0.74||||0.012|TWO_SIDED|95.0|0.26|1.55|||t-test, 2 sided|t = 2.87||Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.55|0.26|.012
73984723|NCT03906240|147513928|SUPERIORITY||Cohen's d|0.02||||0.941|TWO_SIDED|95.0|-0.43|0.55|||t-test, 2 sided|t = 0.08||Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.55|-0.43|.941
73984724|NCT03906240|147513928|SUPERIORITY||Cohen's d|0.25||||0.27|TWO_SIDED|95.0|-0.17|0.79|||t-test, 2 sided|t = 1.14||Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.79|-0.17|.270
73984725|NCT03906240|147513929|SUPERIORITY||Cohen's d|0.08||||0.768|TWO_SIDED|95.0|-0.45|0.71|||t-test, 2 sided|t = 0.30||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.71|-0.45|.768
73984726|NCT03906240|147513929|SUPERIORITY||Cohen's d|0.01||||0.975|TWO_SIDED|95.0|-0.53|0.42|||t-test, 2 sided|t = 0.05||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.42|-0.53|.975
73984727|NCT04405089|147513938|OTHER||Linear regression|0.03|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus Binge Eating Scale score at baseline).||||
73984728|NCT04405089|147513939|OTHER||Linear regression|-0.33|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus NIH Flanker score at baseline).||||
73984729|NCT04405089|147513940|OTHER||Linear regression|0.04|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus NIH Set Shifting score at baseline).||||
74034074|NCT00540436|147620971|SUPERIORITY_OR_OTHER||Mean change|33.49||||||95.0|15.231|51.744||||||||51.744|15.231|
74034075|NCT00540436|147620972|SUPERIORITY_OR_OTHER||Mean change|46.82||||||95.0|24.566|69.076||||||||69.076|24.566|
73984730|NCT03751280|147513941|OTHER||Comparison of adjusted least square mean|0.61|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|90.0|-1.4|2.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||2.6|-1.4|
73984731|NCT03751280|147513941|OTHER||Comparison of adjusted least square mean|0.8|STANDARD_ERROR_OF_MEAN|1.279|||TWO_SIDED|90.0|-1.3|2.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||2.9|-1.3|
73984732|NCT03751280|147513941|OTHER||Comparison of adjusted least square mean|2.73|STANDARD_ERROR_OF_MEAN|1.611||0.0931|TWO_SIDED|90.0|0.1|5.4|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||5.4|0.1|0.0931
73984733|NCT03751280|147513943|OTHER||Comparison of adjusted least square mean|0.21|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-0.6|1.0|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1|-0.6|
73984734|NCT03751280|147513943|OTHER||Comparison of adjusted least square mean|0.61|STANDARD_ERROR_OF_MEAN|0.538|||TWO_SIDED|90.0|-0.3|1.5|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.5|-0.3|
73984735|NCT03751280|147513943|OTHER||Comparison of adjusted least square mean|0.82|STANDARD_ERROR_OF_MEAN|0.648||0.2069|TWO_SIDED|90.0|-0.3|1.9|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||1.9|-0.3|0.2069
73984736|NCT03751280|147513944|OTHER||Comparison of adjusted least square mean|0.51|STANDARD_ERROR_OF_MEAN|0.849|||TWO_SIDED|90.0|-0.9|1.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1.9|-0.9|
73984737|NCT03751280|147513944|OTHER||Comparison of adjusted least square mean|0.12|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|90.0|-1.4|1.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.6|-1.4|
73984738|NCT03751280|147513944|OTHER||Comparison of adjusted least square mean|1.61|STANDARD_ERROR_OF_MEAN|1.071||0.1368|TWO_SIDED|90.0|-0.2|3.4|||t-test, 2 sided|||Day 85||3.4|-0.2|0.1368
73984739|NCT03751280|147513945|OTHER||Comparison of adjusted least square mean|-0.13|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.8|0.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||0.6|-0.8|
73984740|NCT03751280|147513945|OTHER||Comparison of adjusted least square mean|0.15|STANDARD_ERROR_OF_MEAN|0.453|||TWO_SIDED|90.0|-0.6|0.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||0.9|-0.6|
73984741|NCT03751280|147513945|OTHER||Comparison of adjusted least square mean|0.51|STANDARD_ERROR_OF_MEAN|0.581||0.3798|TWO_SIDED|90.0|-0.5|1.5|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|||1.5|-0.5|0.3798
73984742|NCT03751280|147513946|OTHER||Comparison of adjusted least square mean|-0.79|STANDARD_ERROR_OF_MEAN|-0.79|||TWO_SIDED|90.0|-3.2|1.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1.6|-3.2|
73984743|NCT03751280|147513946|OTHER||Comparison of adjusted least square mean|-1.6|STANDARD_ERROR_OF_MEAN|2.006|||TWO_SIDED|90.0|-4.9|1.7|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.7|-4.9|
73984744|NCT03751280|147513946|OTHER||Comparison of adjusted least square mean|-4.07|STANDARD_ERROR_OF_MEAN|1.78||0.0245|TWO_SIDED|90.0|-7.0|-1.1|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||-1.1|-7.0|0.0245
73984745|NCT03751280|147513947|OTHER||Comparison of adjusted least square mean|-0.18|STANDARD_ERROR_OF_MEAN|0.516|||TWO_SIDED|90.0|-1.0|0.7|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29-Domain 1||0.7|-1.0|
73984746|NCT02162771|147513980|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|102.25|||||TWO_SIDED|90.0|94.05|111.17|||ANCOVA|Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.||Equivalence in AUCtau between CT-P10 and Rituxan||111.17|94.05|
73984747|NCT02162771|147513981|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|100.67|||||TWO_SIDED|90.0|93.84|108.0|||ANCOVA|Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.||Equivalence in Cmax,ss between CT-P10 and Rituxan||108.00|93.84|
73984748|NCT02162771|147513982|NON_INFERIORITY|Non-inferiority margin of -7% was predefined.|Point estimate difference|4.3|||||TWO_SIDED|||||||||||||
73984749|NCT03594266|147514035|OTHER||||||<|0.0001|||||||paired t-test, two-sided|||||||<0.0001
73984750|NCT03594266|147514035|OTHER||||||<|0.0001|||||||paired t-test, two-sided|||||||<0.0001
73984751|NCT03594266|147514036|OTHER|||||||0.5482|||||||two-sample t-test, 2-sided|||||||0.5482
74034076|NCT03255291|147620981|SUPERIORITY|A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0288|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||The investigators tested whether weekly minutes of exercise at 90 day follow-up was higher in the exercise mental imagery condition than in the sleep mental imagery condition||||0.0288
73874799|NCT03726489|147291442|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|18.6|||<|0.001|TWO_SIDED|95.0|11.8|25.3||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||25.3|11.8|<0.001
73956169|NCT00320489|147448029|SUPERIORITY_OR_OTHER|||||||0.649||95.0||||P-Value is for change from baseline at Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.649
73956170|NCT00320489|147448030|SUPERIORITY_OR_OTHER|||||||0.744||95.0||||P-value for change at Week 104 in Mental Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.744
73956171|NCT00320489|147448030|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||P-value for change at Week 104 in Physical Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.653
73956172|NCT00320489|147448030|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||P-value for change at Week 104 in Physical Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.640
73956173|NCT00320489|147448030|SUPERIORITY_OR_OTHER|||||||0.454||95.0||||P-value for change at Week 104 in Role-Physical.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.454
73956174|NCT00320489|147448030|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for change at Week 104 in Bodily Pain.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.135
73956175|NCT00320489|147448030|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||P-value for change at Week 104 in General Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.229
73956176|NCT00320489|147448030|SUPERIORITY_OR_OTHER|||||||0.594||95.0||||P-value for change at Week 104 in Vitality.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.594
73956177|NCT00320489|147448030|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||P-value for change at Week 104 in Social Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.256
73956178|NCT00320489|147448030|SUPERIORITY_OR_OTHER|||||||0.775||95.0||||P-value for change at Week 104 in Role-Emotional.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.775
73956179|NCT00320489|147448030|SUPERIORITY_OR_OTHER|||||||0.781||95.0||||P-value for change at Week 104 in Mental Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.781
73956180|NCT00320489|147448031|SUPERIORITY_OR_OTHER|||||||0.465||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.465
73956181|NCT00320489|147448032|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.581
73956182|NCT00320489|147448035|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|P-value is type III p-value of ANOVA model: Total number of hospitalization days = Therapy.||||||0.020
73956183|NCT00320489|147448036|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||P-value is for Total Score (Items 1-5) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.583
73956184|NCT00320489|147448036|SUPERIORITY_OR_OTHER|||||||0.747||95.0||||P-value is for Total Score (Items 1-4) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.747
73956185|NCT00320489|147448037|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.371
73956186|NCT00320489|147448038|SUPERIORITY_OR_OTHER|||||||0.681||95.0||||P-value is fro change from baseline to Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.681
73956187|NCT00320489|147448039|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value is for overall satisfaction with current medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.60
73956188|NCT00320489|147448039|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for preference current/previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit||||||.258
73956189|NCT00320489|147448039|SUPERIORITY_OR_OTHER|||||||0.492||95.0||||P-value is for side effects - current vs previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.492
73956190|NCT00320489|147448040|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.854
73956191|NCT00320489|147448041|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Fisher Exact|||||||0.600
73956192|NCT00320489|147448042|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.282
73956193|NCT00320489|147448043|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for PANSS Total Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.834
73956194|NCT00320489|147448043|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||P-value is for PANSS Positive Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.871
73956195|NCT00320489|147448043|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||P-value is for PANSS Negative Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.692
73956196|NCT00320489|147448043|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||P-value is for PANSS General Psychopathology Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.893
73956197|NCT00320489|147448044|SUPERIORITY_OR_OTHER|||||||0.585||95.0|||||Log Rank|||||||0.585
73956198|NCT00320489|147448045|SUPERIORITY_OR_OTHER|||||||0.659||95.0|||||Fisher Exact|||||||0.659
73956199|NCT00320489|147448046|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.952
73956200|NCT00320489|147448048|SUPERIORITY_OR_OTHER|||||||0.777||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = baseline, treatment, and investigator.||||||0.777
73956201|NCT00320489|147448049|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Fisher Exact|||||||0.530
74089687|NCT00700817|147732158|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.34||||0.0001||95.0|-0.51|-0.16||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority. Liraglutide 1.2 mg versus sitagliptin only tested if liraglutide 1.8 mg was superior to sitagliptin.||-0.16|-0.51|0.0001
73874800|NCT03726489|147291442|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|21.2|||<|0.001|TWO_SIDED|95.0|11.0|31.5||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||31.5|11.0|<0.001
73984752|NCT03647709|147514043|OTHER||mean score|1.0|||||TWO_SIDED|95.0|0.9|1.2|||||Represents patients pain score post operative day 1 best with rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.||1.2|0.9|
73984753|NCT03647709|147514043|OTHER||mean score|2.4|||||TWO_SIDED|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 1 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.||2.6|2.2|
73984754|NCT03647709|147514043|OTHER||mean score|2.9|||||TWO_SIDED|95.0|2.7|3.1|||||Represents patients reported pain score post operative day 1 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.1|2.7|
73984755|NCT03647709|147514043|OTHER||mean score|4.6|||||TWO_SIDED|95.0|4.4|4.8|||||Represents patients reported pain score post operative day 1 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.8|4.4|
74034077|NCT03255291|147620981|SUPERIORITY|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.3329|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise differed among the three risk display formats: risk ladder, table, and alphanumeric text.||||0.3329
74034078|NCT03255291|147620981|SUPERIORITY|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0215|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise was influenced by an interaction between risk display format and mental imagery behavior||||0.0215
74034079|NCT03255291|147620982|SUPERIORITY|||||||0.0333||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||-This study was designed as a 3X2 factorial design and only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. A Dunnett adjustment was used to adjust for multiple comparisons.||||0.0333
74034080|NCT03255291|147620983|SUPERIORITY|||||||0.4946||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design \& only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.||||0.4946
74034081|NCT03255291|147620984|SUPERIORITY|||||||0.1397|||||||ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design \& only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.||||0.1397
74034082|NCT03255291|147620985|SUPERIORITY|||||||0.007||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise maintenance self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.||||0.0070
74034083|NCT03255291|147620986|SUPERIORITY|||||||0.8793||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise recovery self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.||||0.8793
74034084|NCT03255291|147620987|SUPERIORITY|||||||0.4673||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise affective attitudes). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.4673
73984756|NCT03647709|147514043|OTHER||mean score|1.8|||||TWO_SIDED|95.0|1.6|2.0|||||Represents patients reported pain score post operative day 2 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.0|1.6|
74039541|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.76||||0.072|TWO_SIDED|95.0|0.95|3.24|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.24|0.95|0.0720
73874801|NCT03726489|147291442|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|16.5|||<|0.001|TWO_SIDED|95.0|6.4|26.6||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||26.6|6.4|<0.001
73956202|NCT00320489|147448050|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value for fasting glucose.|Fisher Exact|||||||0.258
73956203|NCT00320489|147448050|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-value is for fasting total cholesterol.|Fisher Exact|||||||0.688
73956204|NCT00320489|147448050|SUPERIORITY_OR_OTHER|||||||0.908||95.0||||P-value is for fasting triglycerides.|Fisher Exact|||||||0.908
73956205|NCT00320489|147448051|SUPERIORITY_OR_OTHER|||||||0.835||95.0|||||Fisher Exact|||||||0.835
73956206|NCT00320489|147448052|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for ALT.|Fisher Exact|||||||0.834
73956207|NCT00320489|147448052|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||P-value is for AST.|Fisher Exact|||||||0.723
73956208|NCT00320489|147448052|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||P-value is for total bilirubin.|Fisher Exact|||||||0.247
73956209|NCT00320489|147448053|SUPERIORITY_OR_OTHER|||||||0.885||95.0|||||Fisher Exact|||||||0.885
73956210|NCT03441984|147448054|OTHER||Ratio of geometric LS means|1.6946|||||TWO_SIDED|90.0|1.569|1.8373|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented|||1.8373|1.5690|
73956211|NCT03441984|147448054|OTHER||Ratio of geometric LS means|1.3512|||||TWO_SIDED|90.0|1.2465|1.4647|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4647|1.2465|
73956212|NCT03441984|147448054|OTHER||Ratio of geometric LS means|1.2541|||||TWO_SIDED|90.0|1.1569|1.3595|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented|||1.3595|1.1569|
73956213|NCT03441984|147448055|OTHER||Ratio of geometric LS means|1.7001|||||TWO_SIDED|90.0|1.5685|1.8428|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8428|1.5685|
73956214|NCT03441984|147448055|OTHER||Ratio of geometric LS means|1.3519|||||TWO_SIDED|90.0|1.2475|1.465|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4650|1.2475|
73956215|NCT03441984|147448055|OTHER||Ratio of geometric LS means|1.2576|||||TWO_SIDED|90.0|1.1605|1.3629|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3629|1.1605|
73956216|NCT03441984|147448056|OTHER||Ratio of geometric LS means|1.7382|||||TWO_SIDED|90.0|1.5983|1.8904|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8904|1.5983|
73956217|NCT03441984|147448056|OTHER||Ratio of geometric LS means|1.3614|||||TWO_SIDED|90.0|1.2525|1.4798|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4798|1.2525|
73874802|NCT03726489|147291442|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%. The sample size for this subgroup did not meet our a priori sample size required for 80% power.|Risk Difference (RD)|16.1||||0.001|TWO_SIDED|95.0|-3.7|35.9||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||35.9|-3.7|0.001
73984757|NCT03647709|147514043|OTHER||mean score|3.4|||||TWO_SIDED|95.0|3.2|3.6|||||Represents patients reported pain score post operative day 2 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.6|3.2|
73984758|NCT03647709|147514043|OTHER||mean score|4.2|||||TWO_SIDED|95.0|4.0|4.4|||||Represents patients reported pain score post operative day 2 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.4|4.0|
73984759|NCT03647709|147514043|OTHER||mean score|5.9|||||TWO_SIDED|95.0|5.7|6.1|||||Represents patients reported pain score post operative day 2 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||6.1|5.7|
73984760|NCT03647709|147514043|OTHER||mean score|1.0|||||TWO_SIDED|95.0|0.8|1.2|||||Represents patients reported pain score post operative day 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.2|0.8|
73984761|NCT03647709|147514043|OTHER||mean score|2.4|||||TWO_SIDED|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.6|2.2|
73984762|NCT03647709|147514043|OTHER||mean score|3.3|||||TWO_SIDED|95.0|3.1|3.5|||||Represents patients reported pain score post operative day 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.5|3.1|
73984763|NCT03647709|147514043|OTHER||mean score|5.0|||||TWO_SIDED|95.0|4.8|5.2|||||Represents patients reported pain score post operative day 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||5.2|4.8|
73984764|NCT03647709|147514043|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.7|||||Represents patients reported pain score post operative days 10-14 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.7|0.4|
73984765|NCT03647709|147514043|OTHER||mean score|2.1|||||TWO_SIDED|95.0|1.9|2.3|||||Represents patients reported pain score post operative days 10-14 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.3|1.9|
73984766|NCT03647709|147514043|OTHER||mean score|2.0|||||TWO_SIDED|95.0|1.8|2.2|||||Represents patients reported pain score post operative days 10-14 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.2|1.8|
73984767|NCT03647709|147514043|OTHER||mean score|4.0|||||TWO_SIDED|95.0|3.8|4.2|||||Represents patients reported pain score post operative days 10-14 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.2|3.8|
73984768|NCT03647709|147514043|OTHER||mean score|0.3|||||TWO_SIDED|95.0|0.2|0.4|||||Represents patients reported pain score post operative week 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.4|0.2|
73984769|NCT03647709|147514043|OTHER||mean score|1.5|||||TWO_SIDED|95.0|1.3|1.7|||||Represents patients reported pain score post operative week 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.7|1.3|
73984770|NCT03647709|147514043|OTHER||mean score|1.3|||||TWO_SIDED|95.0|1.2|1.5|||||Represents patients reported pain score post operative week 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.5|1.2|
73984771|NCT03647709|147514043|OTHER||mean score|3.1|||||TWO_SIDED|95.0|2.9|3.3|||||Represents patients reported pain score post operative week 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.3|2.9|
73984772|NCT03647709|147514043|OTHER||mean score|0.1|||||TWO_SIDED|95.0|0.0|0.2|||||Represents patients reported pain score post operative week 6 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.2|0.0|
73984773|NCT03647709|147514043|OTHER||mean score|0.7|||||TWO_SIDED|95.0|0.5|0.8|||||Represents patients reported pain score post operative week 6 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.8|0.5|
73984774|NCT03647709|147514043|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||Represents patients reported pain score post operative week 6 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.6|0.4|
73984775|NCT03647709|147514043|OTHER||mean score|1.9|||||TWO_SIDED|95.0|1.7|2.0|||||Represents patients reported pain score post operative week 6 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.0|1.7|
74039542|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9926|TWO_SIDED|95.0|0.25|4.0|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.00|0.25|0.9926
73874803|NCT03726489|147291442|OTHER|||||||0.873||||||HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.|Regression, Logistic|We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.||Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.||||0.873
73874804|NCT03726489|147291443|SUPERIORITY||Mean Difference (Final Values)|8.7|||<|0.0001|TWO_SIDED|95.0|7.1|10.4||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||10.4|7.1|<0.0001
73874805|NCT03726489|147291443|SUPERIORITY||Mean Difference (Final Values)|9.38|||<|0.0001|TWO_SIDED|95.0|7.05|11.71||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||11.71|7.05|<0.0001
73874806|NCT03726489|147291443|SUPERIORITY||Mean Difference (Final Values)|8.48|||<|0.0001|TWO_SIDED|95.0|5.82|11.14||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||11.14|5.82|<0.0001
73874807|NCT03726489|147291443|SUPERIORITY||Mean Difference (Final Values)|6.82||||0.0213|TWO_SIDED|95.0|1.06|12.58||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||12.58|1.06|0.0213
73874808|NCT03726489|147291444|SUPERIORITY||Mean Difference (Final Values)|14.6|||<|0.0001|TWO_SIDED|95.0|10.4|18.7||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||18.7|10.4|<0.0001
73874809|NCT03726489|147291444|SUPERIORITY||Mean Difference (Final Values)|11.47|||<|0.0001|TWO_SIDED|95.0|6.93|16.01||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||16.01|6.93|<0.0001
73874810|NCT03726489|147291444|SUPERIORITY||Mean Difference (Final Values)|13.87|||<|0.0001|TWO_SIDED|95.0|7.77|19.98||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||19.98|7.77|<0.0001
73874811|NCT03726489|147291444|SUPERIORITY||Mean Difference (Final Values)|32.84||||0.0127|TWO_SIDED|95.0|7.32|58.35||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||58.35|7.32|0.0127
73984776|NCT03647709|147514043|OTHER||mean score|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Represents patients reported pain score post operative week 12 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.0|-0.0|
73874812|NCT03726489|147291445|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.001|TWO_SIDED|95.0|-1.27|-0.35||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||-0.35|-1.27|0.001
73874813|NCT03726489|147291445|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.0158|TWO_SIDED|95.0|-1.51|-0.16||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||-0.16|-1.51|0.0158
73984777|NCT03647709|147514043|OTHER||mean score|0.2|||||TWO_SIDED|95.0|0.1|0.2|||||Represents patients reported pain score post operative week 12 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.2|0.1|
73956218|NCT03441984|147448056|OTHER||Ratio of geometric LS means|1.2768|||||TWO_SIDED|90.0|1.1746|1.3878|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3878|1.1746|
73956219|NCT03441984|147448057|OTHER||Ratio of geometric LS means|1.0407|||||TWO_SIDED|90.0|1.0118|1.0704|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0704|1.0118|
73956220|NCT03441984|147448057|OTHER||Ratio of geometric LS means|1.0228|||||TWO_SIDED|90.0|0.9944|1.052|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0520|0.9944|
73956221|NCT03441984|147448057|OTHER||Ratio of geometric LS means|1.0175|||||TWO_SIDED|90.0|0.9893|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0465|0.9893|
73956222|NCT03441984|147448058|OTHER||Ratio of geometric LS means|1.041|||||TWO_SIDED|90.0|1.0121|1.0708|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0708|1.0121|
73984778|NCT03647709|147514043|OTHER||mean score|0.0|||||TWO_SIDED|95.0|0.0|0.1|||||Represents patients reported pain score post operative week 12 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.1|-0.0|
73874814|NCT03726489|147291445|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.013|TWO_SIDED|95.0|-1.58|-0.19||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||-0.19|-1.58|0.0130
73874815|NCT03726489|147291445|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.591|TWO_SIDED|95.0|-1.94|1.11||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||1.11|-1.94|0.5910
73874816|NCT03726489|147291445|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.395|TWO_SIDED|95.0|-0.33|0.82||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes at Week 24||0.82|-0.33|0.395
73874817|NCT03726489|147291445|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.774|TWO_SIDED|95.0|-0.69|0.93||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II at Week 24||0.93|-0.69|0.774
73874818|NCT03726489|147291445|SUPERIORITY||Median Difference (Final Values)|0.53||||0.242|TWO_SIDED|95.0|-0.36|1.41||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV at Week 24||1.41|-0.36|0.242
73874819|NCT03726489|147291445|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.692|TWO_SIDED|95.0|-2.72|1.83||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI at Week 24||1.83|-2.72|0.692
73984779|NCT03647709|147514043|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.7|||||Represents patients reported pain score post operative week 12 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.7|0.4|
74034085|NCT03255291|147620988|SUPERIORITY|||||||0.1916||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise unpleasant feelings). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.1916
74034086|NCT03255291|147620989|SUPERIORITY|||||||0.8661||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise imagery vividness). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.8661
74034087|NCT03255291|147620990|SUPERIORITY|||||||0.0711||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.0711
73984780|NCT03647709|147514046|OTHER|||||||0.0015|||||||Fisher Exact|||||||0.0015
73984781|NCT03647709|147514047|OTHER|||||||0.6398|||||||Fisher Exact|||||||.6398
73984782|NCT03647709|147514048|OTHER|||||||0.0658|||||||Fisher Exact|||||||.0658
73984783|NCT03647709|147514049|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73984784|NCT00449033|147514056|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.401||95.0|0.83|1.16|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||Sample size based on the primary efficacy endpoint of OS in the ITT (non-squamous) population. Clinically meaningful improvement defined as 30% increase in median OS (that is, a hazard ratio of 0.76923, Sorafenib+GC over Placebo+GC). With one-sided alpha of 0.025, power of 86% and a randomization ratio of 1:1 between Sorafenib+GC and Placebo+GC, and one formal final analysis of OS performed, a total of 544 events (deaths) were required.||1.16|0.83|0.401
73984785|NCT00449033|147514057|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.563||95.0|0.87|1.18|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same factors as randomization plus histology.||||1.18|0.87|0.563
73984786|NCT00449033|147514059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.008||95.0|0.71|0.97|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||0.97|0.71|0.008
73984787|NCT00449033|147514060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0004||95.0|0.6|0.88|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||0.88|0.60|0.0004
73984788|NCT00449033|147514061|SUPERIORITY_OR_OTHER||Difference in Tumour Response (CR+PR)|-1.92||||0.2733||95.0|-8.19|4.34|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||4.34|-8.19|0.2733
73984789|NCT00449033|147514062|SUPERIORITY_OR_OTHER||Difference in Disease Control|0.97||||0.3902||95.0|-5.87|7.81|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||7.81|-5.87|0.3902
73984790|NCT02032420|147514082|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Repeated-measures MANOVA|The reported p value is for the effect of group assignment across three iterations of the assigned task.||||||<0.001
74034088|NCT03255291|147620991|SUPERIORITY|||||||0.0365||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise coping planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.0365
73984791|NCT02032420|147514083|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Repeated-measures MANOVA|The p value is for the effect of group assignment across three iterations of the assigned task.||||||0.004
73984792|NCT02032420|147514084|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.038
73984793|NCT02032420|147514085|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
73984794|NCT02332824|147514132|SUPERIORITY_OR_OTHER||LS Mean difference|-0.325|||<|0.0001|TWO_SIDED|95.0|-0.4845|-0.1649||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 5 mg-placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.1649|-0.4845|<0.0001
73984795|NCT02332824|147514132|SUPERIORITY_OR_OTHER||LS Mean difference|-0.469|||<|0.0001|TWO_SIDED|95.0|-0.6251|-0.3132||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 20 mg-placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.3132|-0.6251|<0.0001
73984796|NCT02332824|147514132|SUPERIORITY_OR_OTHER||LS Mean difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.7897|-0.4711||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 40 mg -placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.4711|-0.7897|<0.0001
73874820|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|-2.59||||0.1209|TWO_SIDED|95.0|-5.86|0.68||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Initiation||0.68|-5.86|0.1209
73874821|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|-2.13||||0.2581|TWO_SIDED|95.0|-6.0|1.75||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Initiation||1.75|-6.0|0.2581
73956223|NCT03441984|147448058|OTHER||Ratio of geometric LS means|1.0232|||||TWO_SIDED|90.0|0.9948|1.0524|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0524|0.9948|
73956224|NCT03441984|147448058|OTHER||Ratio of geometric LS means|1.0174|||||TWO_SIDED|90.0|0.9892|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0465|0.9892|
73956225|NCT03441984|147448059|OTHER||Ratio of geometric LS means|1.0533|||||TWO_SIDED|90.0|0.9885|1.1223|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.1223|0.9885|
73984797|NCT02332824|147514132|SUPERIORITY_OR_OTHER||LS Mean difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.8083|-0.4908||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 80 mg -placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.4908|-0.8083|<0.0001
73984798|NCT02332824|147514132|SUPERIORITY_OR_OTHER||LS Mean difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.6874|-0.3719||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (Candesartan cilexetil 8 mg -placebo group) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.3719|-0.6874|<0.0001
74034089|NCT03255291|147620992|SUPERIORITY|||||||0.1511||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.1511
74034090|NCT00471445|147620993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.19||0.363|TWO_SIDED|95.0|-0.548|0.201|||ANCOVA|||Tested at the two-sided 0.05 significance level.||0.201|-0.548|0.363
74034091|NCT01067508|147621001|OTHER|||||||0.003||||||p\<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to 12 weeks minus baseline change in Fiji water group||||0.003
74034092|NCT01067508|147621001|OTHER|||||||0.68||||||p\<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to the 12 week minus baseline change in Aquafina (control) group||||0.68
73956226|NCT03441984|147448059|OTHER||Ratio of geometric LS means|0.9766|||||TWO_SIDED|90.0|0.9167|1.0405|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0405|0.9167|
73956227|NCT03441984|147448059|OTHER||Ratio of geometric LS means|1.0785|||||TWO_SIDED|90.0|1.0123|1.149|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1490|1.0123|
74034093|NCT00962039|147621002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.92|TWO_SIDED|95.0|-0.12|0.1||Analyses were conducted over 8 week follow-up.|Chi-squared|||||0.10|-0.12|0.92
74034094|NCT00962039|147621003|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.08||||0.034|TWO_SIDED|95.0|-0.15|-0.01|||Chi-squared|||||-0.01|-0.15|0.034
74034095|NCT00962039|147621004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.03||||0.261|TWO_SIDED|95.0|-0.07|0.02|||t-test, 2 sided|||||0.02|-0.07|0.261
74034096|NCT00962039|147621005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.09||||0.519|TWO_SIDED|95.0|-0.36|0.18|||t-test, 2 sided|||||0.18|-0.36|0.519
74034097|NCT00962039|147621006|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.704|TWO_SIDED|95.0|-0.77|0.52|||t-test, 2 sided|||||0.52|-0.77|0.704
74034098|NCT00962039|147621007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.59||||0.046|TWO_SIDED|95.0|0.01|1.17|||t-test, 2 sided|||||1.17|0.01|0.046
74034099|NCT04594239|147621016|SUPERIORITY||Difference in response rates|78.7|||||TWO_SIDED|95.0|66.3|85.6||||||||85.6|66.3|
74034100|NCT04594239|147621016|SUPERIORITY||Difference in response rates|85.4|||||TWO_SIDED|95.0|70.5|92.3||||||||92.3|70.5|
74034101|NCT04594239|147621016|SUPERIORITY||Difference in response rates|71.8|||||TWO_SIDED|95.0|55.2|82.5||||||||82.5|55.2|
73874822|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|-3.04||||0.2952|TWO_SIDED|95.0|-8.73|2.65||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Initiation||2.65|-8.73|0.2952
73956228|NCT03441984|147448060|OTHER||Ratio of geometric LS means|1.0|||||TWO_SIDED|90.0|0.9536|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0486|0.9536|
73956229|NCT03441984|147448060|OTHER||Ratio of geometric LS means|0.9478|||||TWO_SIDED|90.0|0.9039|0.9939|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9939|0.9039|
73874823|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|-2.61||||0.6324|TWO_SIDED|95.0|-13.12|7.89||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Initiation||7.89|-13.12|0.6324
73874824|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|0.15||||0.9163|TWO_SIDED|95.0|-2.56|2.85||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Discontinuation||2.85|-2.56|0.9163
73984799|NCT00914732|147514139|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.74|||||TWO_SIDED|97.5|-1.23|-0.25||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable||-0.25|-1.23|
73984800|NCT00914732|147514140|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.83|||||TWO_SIDED|97.5|-1.32|-0.33||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable||-0.33|-1.32|
73984801|NCT00914732|147514141|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|97.5|-0.43|0.52||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.52|-0.43|
73984802|NCT00914732|147514142|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.27|||||TWO_SIDED|97.5|-0.77|0.23||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.23|-0.77|
73984803|NCT00914732|147514145|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.34|||||TWO_SIDED|97.5|-0.3|0.71||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.71|-0.3|
74009206|NCT00397033|147569184|SUPERIORITY_OR_OTHER||LS Means Difference|-8.3|STANDARD_ERROR_OF_MEAN|2.8||0.003||95.0|-13.8|-2.9||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER high dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.||-2.9|-13.8|0.003
73874825|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|0.31||||0.8551|TWO_SIDED|95.0|-3.03|3.66||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Discontinuation||3.66|-3.03|0.8551
74039543|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3726|TWO_SIDED|95.0|0.51|6.04|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||6.04|0.51|0.3726
73874826|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|0.72||||0.7678|TWO_SIDED|95.0|-4.05|5.48||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Discontinuation||5.48|-4.05|0.7678
73874827|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|-3.03||||0.3446|TWO_SIDED|95.0|-8.88|2.82||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Discontinuation||2.82|-8.88|0.3446
73874828|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|-1.26||||0.5716|TWO_SIDED|95.0|-5.64|3.11||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Initiation at Week 24||3.11|-5.64|0.5716
73874829|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|-0.44||||0.8756|TWO_SIDED|95.0|-6.03|5.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Initiation at Week 24||5.14|-6.03|0.8756
73874830|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|-2.07||||0.5686|TWO_SIDED|95.0|-9.18|5.04||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Initiation at Week 24||5.04|-9.18|0.5686
73874831|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|-1.39||||0.866|TWO_SIDED|95.0|-17.5|14.7||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Initiation at Week 24||14.7|-17.5|0.8660
73874832|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|0.19||||0.8779|TWO_SIDED|95.0|-2.24|2.62||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Discontinuation at Week 24||2.62|-2.24|0.8779
73874833|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|0.38||||0.7985|TWO_SIDED|95.0|-2.52|3.28||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Discontinuation at Week 24||3.28|-2.52|0.7985
73874834|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|0.69||||0.7585|TWO_SIDED|95.0|-3.71|5.09||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Discontinuation at Week 24||5.09|-3.71|0.7585
73874835|NCT03726489|147291446|SUPERIORITY||Risk Difference (RD)|-2.78||||0.3422|TWO_SIDED|95.0|-8.15|2.59||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Discontinuation at Week 24||2.59|-8.15|0.3422
73956230|NCT03441984|147448060|OTHER||Ratio of geometric LS means|1.055|||||TWO_SIDED|90.0|1.0061|1.1063|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1063|1.0061|
74034102|NCT00091390|147621022|SUPERIORITY_OR_OTHER_LEGACY||hazard rate|0.0014|||<|0.0001|TWO_SIDED|95.0|0.0|0.003|||Z-test|One-sided.||The study is designed to test whether the 18-month late GU/GI toxicity following the protocol treatment is above 10% (hazard rate of 0.012/month). The sample size is determined so that the probability of rejecting the treatment because of excessive late toxicity is 90% if the true late toxicity rate is 20% (hazard rate of 0.025/month). Ninety-eight patients are required to with an additional 18 months of follow-up to have a statistical power of 90% with one-sided significance level of 0.05.||0.003|0|<0.0001
74034103|NCT03229759|147621030|SUPERIORITY||Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|0.88|2.08||||||Test on abdomen Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.08|0.88|
73874836|NCT03726489|147291447|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.094|TWO_SIDED|95.0|-6.95|0.55||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||0.55|-6.95|0.094
73874837|NCT03726489|147291447|SUPERIORITY||Mean Difference (Final Values)|-5.26||||0.0393|TWO_SIDED|95.0|-10.26|-0.26||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||-0.26|-10.26|0.0393
73874838|NCT03726489|147291447|SUPERIORITY||Mean Difference (Final Values)|-3.92||||0.1505|TWO_SIDED|95.0|-9.28|1.44||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||1.44|-9.28|0.1505
73874839|NCT03726489|147291447|SUPERIORITY||Mean Difference (Final Values)|10.42||||0.284|TWO_SIDED|95.0|-9.0|29.84||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||29.84|-9.0|0.2840
73874840|NCT03726489|147291448|OTHER||Mean|19.87|STANDARD_DEVIATION|61.6|||TWO_SIDED|||||P-value is not applicable.||||Overall analysis adjusted for all skin phototypes||||
73874841|NCT03726489|147291448|OTHER||Mean|18.06|STANDARD_DEVIATION|57.04|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes I/II||||
73874842|NCT03726489|147291448|OTHER||Mean|23.46|STANDARD_DEVIATION|70.71|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes III/IV||||
73874843|NCT03726489|147291448|OTHER||Mean|9.22|STANDARD_DEVIATION|5.66|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes V/VI||||
73874844|NCT03726489|147291449|OTHER||Mean|50.3|STANDARD_DEVIATION|46.7|||TWO_SIDED|||||P-value is not applicable.||||Overall analysis adjusted for all skin phototypes||||
73874845|NCT03726489|147291449|OTHER||Mean|53.19|STANDARD_DEVIATION|50.05|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes I/II||||
73874846|NCT03726489|147291449|OTHER||Mean|49.82|STANDARD_DEVIATION|47.43|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes III/IV||||
73874847|NCT03726489|147291449|OTHER||Mean|39.72|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes V/VI||||
73984804|NCT00914732|147514146|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.02|||||TWO_SIDED|97.5|-0.31|0.35||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.35|-0.31|
73984805|NCT00914732|147514147|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.35|||||TWO_SIDED|97.5|-0.74|0.04||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.04|-0.74|
73984806|NCT00914732|147514148|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x108 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x108 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Lyophilized SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|97.5|-0.81|-0.12||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||-0.12|-0.81|
73984807|NCT04150250|147514196|SUPERIORITY||Difference in Median|-7.1||||0.2254|TWO_SIDED|95.0|-30.9|28.6||The threshold to define success on the primary efficacy endpoint at the final analysis is one-sided alpha = 0.0238.|Van Elteren test|Stratified by blood type group (O vs. Non-O)||||28.6|-30.9|0.2254
73984808|NCT04150250|147514197|SUPERIORITY||Difference in Median|-3.8||||0.2751|TWO_SIDED|95.0|-26.3|27.4|||Van Elteren test|Stratified by blood type group||||27.4|-26.3|0.2751
73984809|NCT04150250|147514199|SUPERIORITY||Difference|-11.3||||0.5145|TWO_SIDED|95.0|-44.1|21.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||21.6|-44.1|0.5145
73984810|NCT04150250|147514200|SUPERIORITY||Difference|-6.3||||0.2636|TWO_SIDED|95.0|-18.1|5.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||5.6|-18.1|0.2636
73984811|NCT04150250|147514201|SUPERIORITY||Difference in Median|1.1||||0.5992|TWO_SIDED|95.0|-4.5|7.8|||Van Elteren test|Stratified by blood type group||||7.8|-4.5|0.5992
73984812|NCT04150250|147514203|SUPERIORITY|||||||0.6527|||||||Log Rank|Stratified by blood type group||||||0.6527
73984813|NCT04150250|147514204|SUPERIORITY||Difference in Median|1.5||||0.5377|TWO_SIDED|95.0|-7.0|5.5|||Van Elteren test|Stratified by blood type group||||5.5|-7.0|0.5377
73984814|NCT04150250|147514205|SUPERIORITY||Difference|1.3||||0.8705|TWO_SIDED|95.0|-14.0|16.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||16.5|-14.0|0.8705
73984815|NCT04150250|147514206|SUPERIORITY||Difference|-18.8||||0.1404|TWO_SIDED|95.0|-41.1|3.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group||||3.6|-41.1|0.1404
73984816|NCT01178281|147514247|OTHER|||||||1|||||||Fisher Exact|||||||1.000
73984817|NCT01178281|147514249|OTHER|||||||0.929|||||||Log Rank|||||||0.929
73984818|NCT01184859|147514257|SUPERIORITY_OR_OTHER|||||||0.211||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.211
73984819|NCT01184859|147514257|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.010
74034104|NCT03229759|147621030|SUPERIORITY||Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|0.72|1.96||||||Tested on the abdomen Analysis was performed based on deferral letters from the FDA. Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||1.96|0.72|
73984820|NCT01184859|147514257|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||<0.001
73984821|NCT01184859|147514257|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||<0.001
73984822|NCT01184859|147514258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.272||||0.194|TWO_SIDED|95.0|-0.685|-0.141||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.141|-0.685|0.194
73984823|NCT01184859|147514258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.547||||0.015|TWO_SIDED|95.0|-0.985|-0.108||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.108|-0.985|0.015
73874848|NCT03726489|147291450|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|11.97|||<|0.0001|TWO_SIDED|95.0|6.52|17.42||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||17.42|6.52|<0.0001
73956231|NCT03441984|147448061|OTHER||Ratio of geometric LS means|0.9994|||||TWO_SIDED|90.0|0.9525|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0486|0.9525|
73956232|NCT03441984|147448061|OTHER||Ratio of geometric LS means|0.9432|||||TWO_SIDED|90.0|0.899|0.9896|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9896|0.8990|
73956233|NCT03441984|147448061|OTHER||Ratio of geometric LS means|1.0596|||||TWO_SIDED|90.0|1.0099|1.1117|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1117|1.0099|
73956234|NCT03441984|147448062|OTHER||Ratio of geometric LS means|0.9362|||||TWO_SIDED|90.0|0.8677|1.0101|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0101|0.8677|
73956235|NCT03441984|147448062|OTHER||Ratio of geometric LS means|0.9079|||||TWO_SIDED|90.0|0.8416|0.9795|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9795|0.8416|
73956236|NCT03441984|147448062|OTHER||Ratio of geometric LS means|1.0312|||||TWO_SIDED|90.0|0.9558|1.1124|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1124|0.9558|
73956237|NCT03441984|147448063|OTHER||Ratio of geometric LS means|1.6439|||||TWO_SIDED|90.0|1.4649|1.8449|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.8449|1.4649|
73956238|NCT03441984|147448063|OTHER||Ratio of geometric LS means|1.2698|||||TWO_SIDED|90.0|1.1315|1.425|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4250|1.1315|
73956239|NCT03441984|147448063|OTHER||Ratio of geometric LS means|1.2946|||||TWO_SIDED|90.0|1.1536|1.4529|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4529|1.1536|
73956240|NCT03441984|147448064|OTHER||Ratio of geometric LS means|1.6578|||||TWO_SIDED|90.0|1.4709|1.8685|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.8685|1.4709|
73956241|NCT03441984|147448064|OTHER||Ratio of geometric LS means|1.2755|||||TWO_SIDED|90.0|1.1317|1.4375|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4375|1.1317|
73956242|NCT03441984|147448064|OTHER||Ratio of geometric LS means|1.2998|||||TWO_SIDED|90.0|1.1533|1.465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4650|1.1533|
73956243|NCT03441984|147448065|OTHER||Ratio of geometric LS means|1.9758|||||TWO_SIDED|90.0|1.7585|2.2201|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||2.2201|1.7585|
73956244|NCT03441984|147448065|OTHER||Ratio of geometric LS means|1.2873|||||TWO_SIDED|90.0|1.1457|1.4465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4465|1.1457|
73956245|NCT03441984|147448065|OTHER||Ratio of geometric LS means|1.5348|||||TWO_SIDED|90.0|1.366|1.7245|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.7245|1.3660|
73956246|NCT03441984|147448066|OTHER||Ratio of geometric LS means|0.9798|||||TWO_SIDED|90.0|0.9241|1.0389|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0389|0.9241|
73956247|NCT03441984|147448066|OTHER||Ratio of geometric LS means|0.9605|||||TWO_SIDED|90.0|0.9059|1.0185|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0185|0.9059|
73956248|NCT03441984|147448066|OTHER||Ratio of geometric LS means|1.0201|||||TWO_SIDED|90.0|0.9633|1.0802|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0802|0.9633|
73956249|NCT03441984|147448067|OTHER||Ratio of geometric LS means|0.9831|||||TWO_SIDED|90.0|0.9243|1.0457|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0457|0.9243|
73956250|NCT03441984|147448067|OTHER||Ratio of geometric LS means|0.9702|||||TWO_SIDED|90.0|0.9121|1.032|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0320|0.9121|
73956251|NCT03441984|147448067|OTHER||Ratio of geometric LS means|1.0134|||||TWO_SIDED|90.0|0.9527|1.0779|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0779|0.9527|
73956252|NCT03441984|147448068|OTHER||Ratio of geometric LS means|0.91|||||TWO_SIDED|90.0|0.8196|1.0102|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0102|0.8196|
73956253|NCT03441984|147448068|OTHER||Ratio of geometric LS means|0.9198|||||TWO_SIDED|90.0|0.8285|1.0212|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0212|0.8285|
73956254|NCT03441984|147448068|OTHER||Ratio of geometric LS means|0.9893|||||TWO_SIDED|90.0|0.8911|1.0983|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0983|0.8911|
73984824|NCT01184859|147514258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.854|||<|0.001|TWO_SIDED|95.0|-1.317|-0.391||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.391|-1.317|<0.001
73984825|NCT01184859|147514258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.888||||0.001|TWO_SIDED|95.0|-1.426|-0.351||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.351|-1.426|0.001
73984826|NCT01232569|147514277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.5|||<|0.001|TWO_SIDED|95.0|22.0|37.0|||Cochran-Mantel-Haenszel|Analysis adjusted for the randomization stratification factors applied at Baseline (region and weight category).||||37.0|22.0|<0.001
73984827|NCT04044352|147514295|OTHER|Likelihood ratio test was the statistical test.|Odds Ratio (OR)|0.81||||0.126|TWO_SIDED|95.0|0.62|1.06|||Wald Chi-Square||A two-fold increase in HAI pre-challenge titer (i.e. one unit increase in log-2 titer) corresponds to a 19% decrease in the odds of developing MMID during the study challenge period (Day 2 through Day 8).|Pre-challenge (baseline) HAI geometric mean titer was log-2 transformed and treated as a continuous variable in the model.||1.06|0.62|0.126
73984828|NCT02123797|147514367|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0007|TWO_SIDED|95.0|1.35|3.06||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive stage confirmation (numerator=108/70) to Serial Care patients with and without invasive stage confirmation (denominator=168/180) after adjustment for matched study.|||3.06|1.35|0.0007
73984829|NCT02123797|147514368|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0022|TWO_SIDED|95.0|1.25|2.8||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive mediastinal staging (numerator=91/87) to Serial Care patients with and without mediastinal invasive staging (denominator=126/222) after adjustment for matched study.|||2.80|1.25|0.0022
73984830|NCT02123797|147514369|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0004|TWO_SIDED|95.0|1.67|5.85||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without bi-modal staging (numerator=161/17) to Serial Care patients with and without bi-modal staging (denominator=267/81) after adjustment for matched study design.|||5.85|1.67|0.0004
73984831|NCT02123797|147514370|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.5|3.36||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without tri-modal staging (numerator=99/79) to Serial Care patients with and without tri-modal staging (denominator=132/216) after adjustment for matched study design.|||3.36|1.50|<0.0001
74034105|NCT03229759|147621030|SUPERIORITY||Mean Difference (Final Values)|1.93|||||TWO_SIDED|95.0|1.38|2.47||||||Groin||2.47|1.38|
73984832|NCT02123797|147514371|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0366|TWO_SIDED|95.0|1.665|3.996||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive staging (numerator=108/70) to Serial Care patients not in conference with and without invasive staging (denominator=122/150) after adjustment for matched study design.|||3.996|1.665|0.0366
73984833|NCT02123797|147514371|SUPERIORITY||Odds Ratio (OR)|2.621||||0.0779|TWO_SIDED|95.0|1.473|4.665||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without invasive staging (numerator=46/30) to Serial Care patients not in conference with and without invasive staging (denominator=122/150) after adjustment for matched study design.|||4.665|1.473|0.0779
73984834|NCT02123797|147514372|SUPERIORITY||Odds Ratio (OR)|2.358||||0.0703|TWO_SIDED|95.0|1.536|3.621||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without mediastinal staging (numerator=91/87) to Serial Care patients not in conference with and without mediastinal staging (denominator=86/186) after adjustment for matched study.|||3.621|1.536|0.0703
73984835|NCT02123797|147514372|SUPERIORITY||Odds Ratio (OR)|2.535||||0.0631|TWO_SIDED|95.0|1.446|4.444||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without mediastinal staging (numerator=40/36) to Serial Care patients not in conference with and without mediastinal staging (denominator=86/186) after adjustment for matched study.|||4.444|1.446|0.0631
73984836|NCT02123797|147514373|SUPERIORITY||Odds Ratio (OR)|3.191||||0.001|TWO_SIDED|95.0|1.671|6.093||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without bi-modal staging (numerator=161/17) to Serial Care patients not in conference with and without bi-modal staging (denominator=205/67) after adjustment for matched study.|||6.093|1.671|0.0010
74034106|NCT03229759|147621030|SUPERIORITY||Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|0.73|1.79||||||Groin||1.79|0.73|
73984837|NCT02123797|147514373|SUPERIORITY||Odds Ratio (OR)|1.103||||0.1972|TWO_SIDED|95.0|0.526|2.314||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without bi-modal staging (numerator=62/14) to Serial Care patients not in conference with and without bi-modal staging (denominator=205/67) after adjustment for matched study.|||2.314|0.526|0.1972
73984838|NCT02123797|147514374|SUPERIORITY||Odds Ratio (OR)|2.739||||0.0055|TWO_SIDED|95.0|1.785|4.203|||Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without tri-modal staging (numerator=99/79) to Serial Care patients not in conference with and without tri-modal staging (denominator=93/179) after adjustment for matched study.|||4.203|1.785|0.0055
74034107|NCT00797797|147621050|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||The responder rates between 'No Treatment Added' and 'Milnacipran Added' groups were compared using a logistic regression model.||||<0.001
74034108|NCT00797797|147621051|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-14.35|||||TWO_SIDED|95.0|-18.99|-9.71|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-9.71|-18.99|
73874849|NCT03726489|147291450|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|16.15|||<|0.0001|TWO_SIDED|95.0|7.54|24.75||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||24.75|7.54|<0.0001
73874850|NCT03726489|147291450|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|5.56|||<|0.0001|TWO_SIDED|95.0|-2.35|13.46||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||13.46|-2.35|<0.0001
73984839|NCT02123797|147514374|SUPERIORITY||Odds Ratio (OR)|2.242||||0.2572|TWO_SIDED|95.0|1.287|3.905||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without tri-modal staging (numerator=39/37) to Serial Care patients not in conference with and without tri-modal staging (denominator=93/179) after adjustment for matched study.|||3.905|1.287|0.2572
73984840|NCT02123797|147514375|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0045|TWO_SIDED|95.0|1.24|3.25||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without stage appropriate treatment (numerator=140/33) to SC patients with and without stage appropriate treatment (denominator=232/106) after adjustment for matched study.|||3.25|1.24|0.0045
73984841|NCT02123797|147514376|SUPERIORITY||Odds Ratio (OR)|2.249||||0.0474|TWO_SIDED|95.0|1.368|3.699||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without stage appropriate treatment (numerator=140/33) to SC patients not in conference with and without stage appropriate treatment (denominator=174/91) after adjustment for matched study.|We examined treatment selection practices with or without MD care in a single healthcare system.||3.699|1.368|0.0474
73984842|NCT02123797|147514376|SUPERIORITY||Odds Ratio (OR)|1.751||||0.6353|TWO_SIDED|95.0|0.91|3.37||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing SC patients in conference with and without stage appropriate treatment (numerator=58/15) to SC patients not in conference with and without stage appropriate treatment (denominator=174/91) after adjustment for matched study.|||3.370|0.910|0.6353
74034109|NCT01575197|147621052|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Fisher Exact|||||||0.014
74034110|NCT01575197|147621053|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Fisher Exact|||||||0.16
74034111|NCT01575197|147621054|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||t-test, 2 sided|||||||0.038
74034112|NCT01575197|147621055|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
74034113|NCT03007485|147621076|SUPERIORITY||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0||||Reported p-value was calculated|t-test, 2 sided|||Sample size and power calculation was a composite of COPD-related hospital readmissions or death within 6 months of discharge. First level of analysis was the ITT, which included all the patients randomly assigned to an arm at the beginning of the study (excluding those who were found to not meet inclusion criteria for referral). The second included all the patients medically cleared and third included all the patients who were medically cleared and who had participated in at least 1 PR session.|"The primary outcome was a composite of COPD-related hospital readmissions or death within 6 months of discharge (binary: yes/no). Logistic regression was used to compare the primary outcome in terms of the OR of event rates between the 2 arms, in 3 sets of models (per each of the 3 aforementioned level of analyses):~* Model 1: Treatment arm only with no other covariates added to the model~* Model 2: Treatment arm, adjusted for race and clinical site (stratification variables)~* Model 3: Treatment arm, adjusted for race, clinical site, and risk factors reported in the literature to be associated with the primary outcome, for explanatory purposes To examine the role of adherence on the primary outcome, we included adherence as a binary variable and as a continuous variable (percentage of sessions attended) in the 3 models."|||<.05
73874851|NCT03726489|147291450|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|21.37|||<|0.0001|TWO_SIDED|95.0|7.65|35.09||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||35.09|7.65|<0.0001
73984843|NCT02123797|147514378|SUPERIORITY||Odds Ratio (OR)|2.955||||0.0014|TWO_SIDED|95.0|1.52|5.747||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=140/37) to SC conference patients with and without concordance to recommendations (denominator=45/30) after adjustment for matched study design.|||5.747|1.520|0.0014
74034114|NCT01848054|147621081|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥-10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.||||||<0.05
74034115|NCT01848054|147621088|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥-10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.||||||<0.05
74034116|NCT00818324|147621139|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2|t-test, 2 sided|||||||<0.001
74034117|NCT00818324|147621139|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided|||||||<0.001
73984844|NCT02123797|147514379|SUPERIORITY||Odds Ratio (OR)|3.093||||0.0019|TWO_SIDED|95.0|1.519|6.299||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=145/32) to SC conference patients with and without concordance to recommendations (denominator=49/26) after adjustment for matched study design.|||6.299|1.519|0.0019
73984845|NCT02123797|147514380|SUPERIORITY||Odds Ratio (OR)|40.892||||0.0499|TWO_SIDED|95.0|1.002|999.999||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=174/3) to SC conference patients with and without concordance to recommendations (denominator=71/4) after adjustment for matched study design.|||999.999|1.002|0.0499
73984846|NCT02123797|147514381|SUPERIORITY||Odds Ratio (OR)|2.663||||0.0263|TWO_SIDED|95.0|1.123|6.319||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=158/19) to SC conference patients with and without concordance to recommendations (denominator=60/15) after adjustment for matched study design.|||6.319|1.123|0.0263
74034118|NCT00818324|147621139|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided|||||||<0.001
74034119|NCT00818324|147621139|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided|||||||<0.001
74034120|NCT00818324|147621140|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2.|t-test, 2 sided|||||||<0.001
74034121|NCT00818324|147621140|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided|||||||<0.001
74034122|NCT00818324|147621140|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided|||||||<0.001
74034123|NCT00818324|147621140|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided|||||||<0.001
74034124|NCT02913222|147621164|OTHER|||||||1||||||The threshold for statistical significance was set at p = 0.05.|Fisher Exact|||A priori criteria for success was that we would achieve 90% adherence to attending treatment sessions. Fisher's exact test compared patient adherence to treatment session rates by site and by group.||||1.0
74034125|NCT02913222|147621165|OTHER|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-2.2||||0.32|TWO_SIDED|95.0|-6.51|2.11||The threshold for statistical significance was p = 0.05|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.||2.11|-6.51|0.32
74034126|NCT02913222|147621166|OTHER|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-5.55||||0.14|TWO_SIDED|95.0|-13.1|1.99||The threshold for statistical significance was p = 0.05.|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.||1.99|-13.10|0.14
74034127|NCT04891770|147621195|OTHER||percentage difference|2.5|||||TWO_SIDED|95.0|-2.3|7.3|||||For Cohort 2A versus Cohort 2B, the percentage difference and the corresponding 95% confidence interval was calculated using the stratum-adjusted Mantel-Haenszel method, stratified by HBsAg group (\> 3 and ≤ 3 log10 IU/mL).|||7.3|-2.3|
73984847|NCT02123797|147514382|SUPERIORITY||Odds Ratio (OR)|2.566||||0.1503|TWO_SIDED|95.0|0.711|9.269||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=87/14) to SC conference patients with and without concordance to recommendations (denominator=38/8) after adjustment for matched study design.|||9.269|0.711|0.1503
73984848|NCT02123797|147514395|SUPERIORITY|||||||0.0042|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Diagnostic Biopsy||||0.0042
73984849|NCT02123797|147514395|SUPERIORITY|||||||0.0805|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Non-invasive Staging Test||||0.0805
73984850|NCT02123797|147514395|SUPERIORITY|||||||0.0073|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Invasive Staging Test||||0.0073
74034128|NCT01125176|147621201|OTHER|Exact Clopper-Pearson 95% confidence interval for overall response rate.|Proportion (percent)|85.7|||||TWO_SIDED|95.0|73.5|100.0||||||||100.0|73.5|
74034129|NCT01798706|147621220|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.81|-0.464||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 glomerular filtration rate (eGFR) (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline HbA1c value as a covariate.||-0.464|-0.81|< 0.0001
73984851|NCT02123797|147514395|SUPERIORITY|||||||0.0579|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Definitive Treatment||||0.0579
73984852|NCT02123797|147514396|SUPERIORITY|||||||0.0146|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Diagnostic Biopsy||||0.0146
73984853|NCT02123797|147514396|SUPERIORITY|||||||0.16|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Non-invasive Staging Test||||0.16
73984854|NCT02123797|147514396|SUPERIORITY|||||||0.0014|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Invasive Staging Test||||0.0014
73984855|NCT02123797|147514396|SUPERIORITY|||||||0.0037|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Definitive Treatment||||0.0037
73984856|NCT02123797|147514403|SUPERIORITY|||||||0.7506|||||||Log Rank|||||||0.7506
73984857|NCT02123797|147514403|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.54|TWO_SIDED|95.0|0.85|1.36|||Regression, Cox||Comparison is Multidisciplinary/Serial Care.|||1.36|0.85|0.54
73984858|NCT02123797|147514404|SUPERIORITY|||||||0.4847|||||||Log Rank|||||||0.4847
73984859|NCT02123797|147514404|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.51|TWO_SIDED|95.0|0.87|1.43|||Regression, Cox||Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference|||1.43|0.87|0.51
73984860|NCT02123797|147514404|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.51|TWO_SIDED|95.0|0.84|1.67|||Regression, Cox||Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference|||1.67|0.84|0.51
73984861|NCT02123797|147514405|SUPERIORITY|||||||0.9874|||||||Log Rank|||||||0.9874
73984862|NCT02123797|147514405|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8|TWO_SIDED|95.0|0.82|1.29|||Regression, Cox||Comparison is Multidisciplinary/Serial Care|||1.29|0.82|0.80
73984863|NCT02123797|147514406|SUPERIORITY|||||||0.5377|||||||Log Rank|||||||0.5377
73984864|NCT02123797|147514406|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.73|TWO_SIDED|95.0|0.83|1.34|||Regression, Cox||Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference|||1.34|0.83|0.73
73984865|NCT02123797|147514406|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.73|TWO_SIDED|95.0|0.82|1.57|||Regression, Cox||Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference|||1.57|0.82|0.73
73984866|NCT00443755|147514407|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73984867|NCT00443755|147514408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73984868|NCT00443755|147514409|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
73984869|NCT00443755|147514410|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73984870|NCT00443755|147514411|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in triglyceride levels.||||0.03
74039544|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7874|TWO_SIDED|95.0|0.22|3.12|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.12|0.22|0.7874
73984871|NCT00443755|147514411|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in HDL-C levels.||||0.06
73984872|NCT00443755|147514411|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of mean change in non-HDL-C levels.||||0.06
73984873|NCT00443755|147514412|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.23
73984874|NCT00443755|147514413|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
73984875|NCT00443755|147514414|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.13
73984876|NCT00443755|147514415|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
73984877|NCT00443755|147514416|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
73984878|NCT00443755|147514417|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73984879|NCT00443755|147514418|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.006
73984880|NCT00443755|147514419|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.18
73984881|NCT00443755|147514420|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
73984882|NCT00376935|147514462|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-9.0||||0.1996|ONE_SIDED|98.4||14.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (20 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (20 mcg/kg) arm.||14||0.1996
73984883|NCT00376935|147514462|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-4.0||||0.3135|ONE_SIDED|98.4||17.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (40 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (40 mcg/kg) arm.||17||0.3135
73984884|NCT00376935|147514462|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-4.0||||0.3662|ONE_SIDED|98.4||22.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (60 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (60 mcg/kg) arm.||22||0.3662
73984885|NCT03575572|147514568|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
73984886|NCT03575572|147514568|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
73984887|NCT03575572|147514570|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73984888|NCT03575572|147514570|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
73984889|NCT00157209|147514572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.745||||0.045|TWO_SIDED|95.0|0.533|1.042|||Log Rank|||||1.042|0.533|0.045
73984890|NCT00024102|147514583|NON_INFERIORITY_OR_EQUIVALENCE|The primary measure of efficacy was the hazard ratio for disease recurrence or death in the capecitabine group as compared with the standard chemotherapy group. Capecitabine would be considered noninferior to standard chemotherapy if the hazard ratio was greater than 0.8046. (With the use of a 5-year landmark for descriptive purposes, this ratio corresponds to a 5-year rate of relapse-free survival of 60% for standard chemotherapy and 53% for capecitabine.)|Hazard Ratio (HR)|2.09|||<|0.001|TWO_SIDED|95.0|1.38|3.17||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. A priori formal monitoring for futility and noninferiority was planned at accrual milestones|Regression, Cox|||||3.17|1.38|<0.001
73984891|NCT00024102|147514584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.85||||0.02|TWO_SIDED|95.0|1.11|3.08||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. There is no adjustment for multiple comparisons.|Regression, Cox|||||3.08|1.11|0.02
73984892|NCT01770509|147514600|SUPERIORITY_OR_OTHER|||||||0.652|||||||ANOVA|General Linear Model ANOVA with repeated measures||||||0.652
73984893|NCT01770509|147514601|SUPERIORITY_OR_OTHER|||||||0.645|||||||ANOVA|General Linear Model ANOVA with repeated measures||||||0.645
73984894|NCT02181400|147514620|OTHER|||||||0.04|||||||ANCOVA|||||||0.04
73984895|NCT02181400|147514621|OTHER|||||||0.04|||||||ANCOVA|||||||0.04
73984896|NCT02181400|147514622|OTHER|||||||0.12|||||||ANCOVA|||||||0.12
73984897|NCT02181400|147514623|OTHER|||||||0.32|||||||ANCOVA|||||||0.32
73984898|NCT02181400|147514624|OTHER|||||||0.02|||||||ANCOVA|||||||0.02
73984899|NCT02181400|147514625|OTHER|||||||0.49|||||||ANCOVA|||||||0.49
73984900|NCT03840148|147514656|NON_INFERIORITY|If the lower limit of the 95% CI for the difference in response is greater than or equal to the non-inferiority margin of -15%, non-inferiority will be concluded. Further, if non-inferiority is concluded, superiority will be concluded if the lower limit of the 95% CI for the difference in response is greater than or equal to zero.|Miettinen and Nurminen|12.6||||0.0088|TWO_SIDED|95.0|3.1|22.2||P-value for superiority since the lower confidence interval is greater than 0 for the primary endpoint analysis.|Cochran-Mantel-Haenszel|||||22.2|3.1|0.0088
73984901|NCT03840148|147514657|OTHER||Miettinen and Nurminen|11.7|||||TWO_SIDED|95.0|2.9|21.0||||||||21.0|2.9|
73984902|NCT03840148|147514658|OTHER||Miettinen and Nurminen|4.5|||||TWO_SIDED|95.0|-2.6|12.6||||||||12.6|-2.6|
73984903|NCT03840148|147514659|OTHER||Miettinen and Nurminen|12.3|||||TWO_SIDED|95.0|3.0|21.8||||||||21.8|3.0|
73984904|NCT03840148|147514660|OTHER||Miettinen and Nurminen|3.1|||||TWO_SIDED|95.0|-3.2|10.4||||||||10.4|-3.2|
73984905|NCT03840148|147514661|OTHER||Miettinen and Nurminen|-0.3|||||TWO_SIDED|95.0|-3.5|4.1||||||||4.1|-3.5|
73984906|NCT03840148|147514662|OTHER||Miettinen and Nurminen|1.6|||||TWO_SIDED|95.0|-4.1|8.5||||||||8.5|-4.1|
73984907|NCT03840148|147514663|OTHER||Miettinen and Nurminen|12.1|||||TWO_SIDED|95.0|2.2|21.9||||||||21.9|2.2|
73984908|NCT03840148|147514664|OTHER||Miettinen and Nurminen|7.7|||||TWO_SIDED|95.0|-1.6|17.3||||||||17.3|-1.6|
73984909|NCT03840148|147514665|OTHER||Miettinen and Nurminen|9.9|||||TWO_SIDED|95.0|1.5|18.8||||||||18.8|1.5|
73984910|NCT03840148|147514666|OTHER||Miettinen and Nurminen|3.0|||||TWO_SIDED|95.0|-2.4|9.6||||||||9.6|-2.4|
73984911|NCT03840148|147514676|OTHER||Miettinen and Nurminen|3.5|||||TWO_SIDED|95.0|-2.3|10.5||||||||10.5|-2.3|
73984912|NCT03840148|147514677|OTHER||Miettinen and Nurminen|-1.1|||||TWO_SIDED|95.0|-3.1|1.7||||||||1.7|-3.1|
73984913|NCT03840148|147514678|OTHER||Miettinen and Nurminen|14.9|||||TWO_SIDED|95.0|5.0|24.9||||||||24.9|5.0|
73984914|NCT03840148|147514679|OTHER||Miettinen and Nurminen|12.7|||||TWO_SIDED|95.0|3.7|22.3||||||||22.3|3.7|
73984915|NCT03840148|147514680|OTHER||Miettinen and Nurminen|14.0|||||TWO_SIDED|95.0|3.8|24.3||||||||24.3|3.8|
73984916|NCT03840148|147514681|OTHER||Miettinen and Nurminen|7.7|||||TWO_SIDED|95.0|-1.9|17.7||||||||17.7|-1.9|
73984917|NCT03840148|147514686|OTHER||Miettinen and Nurminen|14.0|||||TWO_SIDED|95.0|3.8|24.3||||||||24.3|3.8|
73984918|NCT03840148|147514688|OTHER||Miettinen and Nurminen|1.7|||||TWO_SIDED|95.0|-3.1|7.3||||||||7.3|-3.1|
73984919|NCT03840148|147514689|OTHER||Miettinen and Nurminen|4.8|||||TWO_SIDED|95.0|-1.1|11.5||||||||11.5|-1.1|
73984920|NCT03840148|147514690|OTHER||Miettinen and Nurminen|8.2|||||TWO_SIDED|95.0|1.2|15.7||||||||15.7|1.2|
73984921|NCT00603278|147514724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|||<|0.001|TWO_SIDED|95.0|0.096|0.318|||ANCOVA|||||0.318|0.096|<0.001
73984922|NCT00603278|147514724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|||<|0.001|TWO_SIDED|95.0|0.127|0.349|||ANCOVA|||||0.349|0.127|<0.001
73984923|NCT00603278|147514724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|||<|0.001|TWO_SIDED|95.0|0.182|0.404|||ANCOVA|||||0.404|0.182|<0.001
73984924|NCT00603278|147514724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.279|||<|0.001|TWO_SIDED|95.0|0.167|0.392|||ANCOVA|||||0.392|0.167|<0.001
73984925|NCT00603278|147514724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|||<|0.001|TWO_SIDED|95.0|0.114|0.337|||ANCOVA|||||0.337|0.114|<0.001
73984926|NCT00546884|147514768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.16|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73984927|NCT04382053|147514769|SUPERIORITY||Least squares mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.297||0.467|TWO_SIDED|90.0|-2.0|2.3|||ANCOVA|||||2.3|-2.0|0.467
73984928|NCT04382053|147514770|SUPERIORITY|||||||0.237||||||One-sided|Mixed Models Analysis|p-value reported is for the treatment factor across all time points||||||0.237
73984929|NCT00924833|147514774|SUPERIORITY_OR_OTHER|||||||0.01||||||"Within subjects effects. Time: P \< 0.01. Time \* treatment: P=0.25~Bonferroni correction. Within the placebo, carvedilol and nebivolol group, p \< 0.01 for Time 3 - Time 1, and Time 3 - Time 2."|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student's t-test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."||||0.01
73874852|NCT03726489|147291451|SUPERIORITY||Risk Difference (RD)|11.68||||0.0065|TWO_SIDED|95.0|3.27|20.08||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||20.08|3.27|0.0065
73874853|NCT03726489|147291451|SUPERIORITY||Risk Difference (RD)|12.31||||0.0478|TWO_SIDED|95.0|0.03|24.49||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||24.49|0.03|0.0478
73874854|NCT03726489|147291451|SUPERIORITY||Risk Difference (RD)|13.25||||0.0431|TWO_SIDED|95.0|0.52|25.98||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||25.98|0.52|0.0431
73874855|NCT03726489|147291451|SUPERIORITY||Risk Difference (RD)|1.5||||0.9133|TWO_SIDED|95.0|-25.5|28.5||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||28.50|-25.50|0.9133
73984930|NCT00924833|147514775|SUPERIORITY_OR_OTHER||||||<|0.05||||||P \< 0.05. Bonferroni correction: p \< 0.05 nebivolol versus carvedilol|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.||||<0.05
73984931|NCT00924833|147514776|SUPERIORITY_OR_OTHER|||||||0.93||||||Within subjects effects. Time: p = 0.03. Time \* treatment: p = 0.12.|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student's t-test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."||||0.93
73984932|NCT00924833|147514779|SUPERIORITY_OR_OTHER||||||<|0.05||||||ANOVA with unpaired Student's t-test, Bonferroni correction. Bonferroni correction. p = 0.05.|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.||||<0.05
73984933|NCT02577315|147514785|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.1|||||TWO_SIDED|90.0|97.466|102.804|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||102.804|97.466|
73984934|NCT02577315|147514786|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|95.51|||||TWO_SIDED|90.0|89.29|102.16|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||102.16|89.29|
73874856|NCT03726489|147291452|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.048|TWO_SIDED|95.0|-15.73|-0.07||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||-0.07|-15.73|0.048
73984935|NCT02577315|147514787|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|102.71|||||TWO_SIDED|90.0|97.309|108.413|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||108.413|97.309|
73984936|NCT02577315|147514788|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|101.07|||||TWO_SIDED|90.0|95.565|106.902|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||106.902|95.565|
74039545|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.19||||0.795|TWO_SIDED|95.0|0.32|4.46|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.46|0.32|0.7950
73874857|NCT03726489|147291452|SUPERIORITY||Mean Difference (Final Values)|-10.67||||0.1199|TWO_SIDED|95.0|-24.15|2.8||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||2.80|-24.15|0.1199
73874858|NCT03726489|147291452|SUPERIORITY||Mean Difference (Final Values)|-5.3||||0.2953|TWO_SIDED|95.0|-15.26|4.66||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||4.66|-15.26|0.2953
73874859|NCT03726489|147291452|SUPERIORITY||Mean Difference (Final Values)|-8.83||||0.5124|TWO_SIDED|95.0|-35.77|18.11||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||18.11|-35.77|0.5124
73874860|NCT03726489|147291453|SUPERIORITY||Risk Difference (RD)|10.9||||0.0173|TWO_SIDED|95.0|1.93|19.87||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||19.87|1.93|0.0173
73984937|NCT02577315|147514789|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.3|||||TWO_SIDED|90.0|97.532|103.149|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||103.149|97.532|
73984938|NCT02577315|147514790|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|93.55|||||TWO_SIDED|90.0|82.86|105.61|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||105.61|82.86|
73984939|NCT03247985|147514791|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Comparison between groups for bilateral operative time.||||0.17
73984940|NCT03247985|147514791|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Comparison between groups for unilateral operative time.||||0.09
73984941|NCT03247985|147514794|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||A p-value of 0.05 was considered statistically significant.||||0.02
73984942|NCT00417989|147514796|NON_INFERIORITY_OR_EQUIVALENCE|Superiority test with margin of 0.35|Mean Difference (Final Values)|0.35|STANDARD_DEVIATION|1.2||0.05|TWO_SIDED|95.0|0.24|0.46||Confidence Interval 95%|ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline glycated hemoglobin level (A1C)||Null - There is no treatment group difference in A1c change from baseline to Week 52. Calculated that the enrollment of 495 patients would provide a power of 90% to detect an absolute difference of 0.35 percentage points in the primary outcome, assuming a SD of 1.2%.||0.46|0.24|0.05
73984943|NCT00417989|147514798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_DEVIATION|2.0||0.84|TWO_SIDED|95.0|0.64|2.41|||Mantel Haenszel|||||2.41|0.64|0.84
73984944|NCT00417989|147514799|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05||95.0|||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC||||||0.05
73984945|NCT00417989|147514800|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05||95.0|||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC||||||0.05
73984946|NCT00417989|147514801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_DEVIATION|16.0|<|0.001||95.0|-9.76|-3.273|||ANCOVA|||||-3.273|-9.760|< 0.001
73984947|NCT00417989|147514803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|7.75|||||||||Mean difference|||||||
73984948|NCT00417989|147514804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|STANDARD_DEVIATION|25.53|||TWO_SIDED||||||Mean Difference|||||||
73984949|NCT01245699|147514806|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74034130|NCT01798706|147621221|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.05|STANDARD_ERROR_OF_MEAN|0.464|<|0.0001|TWO_SIDED|95.0|-5.96|-4.132||Threshold for significance at 0.05 level. Testing sequence continued only when previous endpoint was statistically significant at 0.05.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline 2-hour PPG value as a covariate. Hierarchical testing procedure was used to control type I error at 0.05. Testing was then performed sequentially in the order the endpoints were reported.||-4.132|-5.96|< 0.0001
73984950|NCT01245699|147514807|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
73984951|NCT01245699|147514808|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
73984952|NCT01245699|147514809|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
73984953|NCT00748098|147514823|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-26.0|||<|0.0001|TWO_SIDED|95.0|-35.64|-16.36|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.||||-16.36|-35.64|<0.0001
73984954|NCT00748098|147514824|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-3.07||||0.002|TWO_SIDED|95.0|-5.04|-1.1|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.||||-1.10|-5.04|0.002
73984955|NCT01537120|147514875|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91|||||TWO_SIDED|90.0|0.85|0.96||||||||0.96|0.85|
73984956|NCT01537120|147514876|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|||||TWO_SIDED|90.0|-0.36|-0.23||||||||-0.23|-0.36|
73984957|NCT01537120|147514877|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.46|||||TWO_SIDED|90.0|-0.62|-0.3||||||||-0.30|-0.62|
73984958|NCT02552810|147514880|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculation, 30 (effect size: 0.5, alpha error: 0.05, power: 0.80).|||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73984959|NCT00396097|147514959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.033||0.5762|ONE_SIDED|97.5|-0.071||||ANCOVA|||The null hypothesis was that the individualized treatment arm was not superior to the standard treatment arm; alternative hypothesis that the individualized treatment arm was superior to the standard treatment arm with respect to the mean 24-month AOTD. Using a 2:1 randomization, a two sided sample t-test comparing the root AOTD between the 2 treatment arms with 80% power at a 5% level required 260 subjects. Assuming a 20% attrition rate, approximately 312 subjects were needed for this study.|||-0.071|0.5762
73984960|NCT00396097|147514960|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED||||||ANOVA (Levene's Test)|||||||0.627
73984961|NCT00396097|147514961|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.033||||0.8016|TWO_SIDED|95.0|0.802|1.33|||Regression, Cox|||||1.330|0.802|0.8016
73984962|NCT00396097|147514962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.822|STANDARD_ERROR_OF_MEAN|2.25||0.0101|TWO_SIDED|95.0|1.395|10.249|||ANCOVA|||||10.249|1.395|0.0101
73874861|NCT03726489|147291453|SUPERIORITY||Risk Difference (RD)|13.06||||0.0662|TWO_SIDED|95.0|-0.81|26.94||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||26.94|-0.81|0.0662
73874862|NCT03726489|147291453|SUPERIORITY||Risk Difference (RD)|8.58||||0.1976|TWO_SIDED|95.0|-4.42|21.57||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||21.57|-4.42|0.1976
73874863|NCT03726489|147291453|SUPERIORITY||Risk Difference (RD)|13.04||||0.3595|TWO_SIDED|95.0|-14.6|40.69||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||40.69|-14.60|0.3595
73874864|NCT03726489|147291454|SUPERIORITY||Risk Difference (RD)|7.55||||0.0853|TWO_SIDED|95.0|-1.05|16.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||16.14|-1.05|0.0853
73874865|NCT03726489|147291454|SUPERIORITY||Risk Difference (RD)|2.26||||0.7488|TWO_SIDED|95.0|-11.54|16.06||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||16.06|-11.54|0.7488
73984963|NCT00396097|147514962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.281|STANDARD_ERROR_OF_MEAN|2.471||0.0002|TWO_SIDED|95.0|4.417|14.145|||ANCOVA|||||14.145|4.417|0.0002
73984964|NCT00396097|147514962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.204|STANDARD_ERROR_OF_MEAN|2.495||0.2001|TWO_SIDED|95.0|-1.707|8.114|||ANCOVA|||||8.114|-1.707|0.2001
73984965|NCT00396097|147514963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.899|STANDARD_ERROR_OF_MEAN|3.414|<|0.0001|TWO_SIDED|95.0|30.181|43.618|||ANCOVA|||||43.618|30.181|<0.0001
73984966|NCT00396097|147514963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.517|STANDARD_ERROR_OF_MEAN|3.284|<|0.0001|TWO_SIDED|95.0|42.054|54.98|||ANCOVA|||||54.980|42.054|<.0001
73984967|NCT00396097|147514963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.443|STANDARD_ERROR_OF_MEAN|3.306|<|0.0001|TWO_SIDED|95.0|27.936|40.951|||ANCOVA|||||40.951|27.936|<.0001
73984968|NCT00396097|147514964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.081||0.2618|TWO_SIDED|95.0|-0.068|0.249|||ANCOVA|||||0.249|-0.068|0.2618
74039546|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2065|TWO_SIDED|95.0|0.66|6.68|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||6.68|0.66|0.2065
73874866|NCT03726489|147291454|SUPERIORITY||Risk Difference (RD)|10.12||||0.1051|TWO_SIDED|95.0|-2.03|22.26||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||22.26|-2.03|0.1051
73874867|NCT03726489|147291454|SUPERIORITY||Risk Difference (RD)|17.39||||0.1792|TWO_SIDED|95.0|-7.48|42.27||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||42.27|-7.48|0.1792
73874868|NCT03726489|147291455|SUPERIORITY||Mean Difference (Final Values)|3.07||||0.175|TWO_SIDED|95.0|-1.37|7.5||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||7.50|-1.37|0.175
73874869|NCT03726489|147291455|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.8904|TWO_SIDED|95.0|-6.34|5.51||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||5.51|-6.34|0.8904
73874870|NCT03726489|147291455|SUPERIORITY||Mean Difference (Final Values)|7.59||||0.0412|TWO_SIDED|95.0|0.31|14.88||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||14.88|0.31|0.0412
73874871|NCT03726489|147291455|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.5481|TWO_SIDED|95.0|-13.38|24.38||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||24.38|-13.38|0.5481
73984969|NCT00396097|147514964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.094||0.8926|TWO_SIDED|95.0|-0.172|0.198|||ANCOVA|||||0.198|-0.172|0.8926
73984970|NCT00396097|147514964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.095||0.9566|TWO_SIDED|95.0|-0.192|0.181|||ANCOVA|||||0.181|-0.192|0.9566
73984971|NCT04086576|147515009|SUPERIORITY||||||<|0.0001||||||Yes, used Tukey Kramer pairwise comparisons to adjust for multiple comparisons|ANOVA|ANOVA in repeated measures||Each breathalyzer is compared to the percentage of alcohol in the blood during the time of blood draw (90 minutes).||||<.0001
73984972|NCT00475735|147515101|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.||||||0.341
73984973|NCT00475735|147515101|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.||||||0.001
73984974|NCT00125853|147515150|OTHER|"Linear Mixed effect Modelling, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) = 0.05 (0.09)"||||||0.6|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on ISI||||0.60
73984975|NCT00125853|147515151|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -2.59 (1.34)"||||||0.06|||||||Linear Mixed effect Model, adjusted for|||Comparing treatment effects on ABPM||||0.06
73984976|NCT00125853|147515152|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0/09 (0.14)"||||||0.51|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on total cholesterol||||0.51
73984977|NCT00125853|147515153|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) =0.02 (0.03)"||||||0.48|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on HbA1c||||0.48
73984978|NCT00125853|147515154|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0.21(0.13)"||||||0.09|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on BMI||||0.09
73984979|NCT01614899|147515155|SUPERIORITY||LS Mean difference|-4.8||||0.05|TWO_SIDED|95.0|-9.52|0.0|||Mixed Model for Repeated Measures|||||0.00|-9.52|0.050
73984980|NCT01614899|147515155|SUPERIORITY||LS Mean difference|-4.2||||0.08|TWO_SIDED|95.0|-8.91|0.5|||Mixed Model for Repeated Measures|||||0.50|-8.91|0.080
73984981|NCT01614899|147515156|SUPERIORITY||LS Mean difference|-0.08||||0.594|TWO_SIDED|95.0|-0.354|0.203|||Mixed Model for Repeated Measures|||||0.203|-0.354|0.594
73984982|NCT01614899|147515156|SUPERIORITY||LS Mean difference|-0.18||||0.199|TWO_SIDED|95.0|-0.453|0.095|||Mixed Model for Repeated Measures|||||0.095|-0.453|0.199
73984983|NCT01614899|147515157|SUPERIORITY||LS Mean difference|-1.1||||0.143|TWO_SIDED|95.0|-2.6|0.38|||Mixed Model for Repeated Measures|||||0.38|-2.60|0.143
73984984|NCT01614899|147515157|SUPERIORITY||LS Mean difference|-1.9||||0.01|TWO_SIDED|95.0|-3.4|-0.46|||Mixed Model for Repeated Measures|||||-0.46|-3.40|0.010
73984985|NCT01614899|147515158|SUPERIORITY||LS Mean difference|-1.0||||0.116|TWO_SIDED|95.0|-2.27|0.25|||Mixed Model for Repeated Measures|||||0.25|-2.27|0.116
73984986|NCT01614899|147515158|SUPERIORITY||LS Mean difference|-0.5||||0.388|TWO_SIDED|95.0|-1.8|0.7|||Mixed Model for Repeated Measures|||||0.70|-1.80|0.388
73984987|NCT01614899|147515159|SUPERIORITY||LS Mean difference|-2.5||||0.036|TWO_SIDED|95.0|-4.87|-0.17|||Mixed Model for Repeated Measures|||||-0.17|-4.87|0.036
74034131|NCT01798706|147621222|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.219|<|0.0001|TWO_SIDED|95.0|-1.39|-0.527||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline 7-point SMPG value as a covariate.||-0.527|-1.39|< 0.0001
74034132|NCT01798706|147621223|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.278|<|0.0001|TWO_SIDED|95.0|-1.862|-0.769||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline body weight value as a covariate.||-0.769|-1.862|< 0.0001
73984988|NCT01614899|147515159|SUPERIORITY||LS Mean difference|-1.6||||0.174|TWO_SIDED|95.0|-3.93|0.72|||Mixed Model for Repeated Measures|||||0.72|-3.93|0.174
73984989|NCT02350127|147515163|SUPERIORITY||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|1.22||0.14|TWO_SIDED|95.0|-0.59|4.18|||Mixed Models Analysis|||adjusted for participant baseline MOCA, robust VCE||4.18|-0.59|0.14
73984990|NCT02350127|147515163|SUPERIORITY||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|1.4||0.03|TWO_SIDED|95.0|0.2|5.6|||Mixed Models Analysis|||restricted to completers||5.6|0.2|0.03
73984991|NCT02350127|147515164|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.52||0.68|TWO_SIDED|95.0|-1.23|0.8|||Mixed Models Analysis||Adjusting for baseline participant MOCA scores, robust vce.|||0.80|-1.23|0.68
73984992|NCT02350127|147515165|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|1.32||0.7|TWO_SIDED|95.0|-3.09|2.08|||Mixed Models Analysis|||adjusting for baseline participant MOCA, robust VCE||2.08|-3.09|0.70
73984993|NCT02350127|147515166|SUPERIORITY||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|2.2||0.02|TWO_SIDED|95.0|0.8|9.4|||Mixed Models Analysis|||||9.4|0.8|0.02
73984994|NCT02350127|147515167|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|4.3||0.47|TWO_SIDED|95.0|-5.4|11.6|||Mixed Models Analysis|||||11.6|-5.4|0.47
73984995|NCT02350127|147515168|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.54||0.99|TWO_SIDED|95.0|-1.1|1.1|||Mixed Models Analysis|||||1.1|-1.1|0.99
73984996|NCT02350127|147515169|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|3.7||0.98|TWO_SIDED|95.0|-7.4|7.2|||Mixed Models Analysis|||||7.2|-7.4|0.98
73984997|NCT02350127|147515170|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.5||0.8|TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||||3.3|-2.5|0.80
73984998|NCT02350127|147515171|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.1||0.38|TWO_SIDED|95.0|-3.1|1.2|||Mixed Models Analysis|||||1.2|-3.1|0.38
73984999|NCT02350127|147515172|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.45||0.075|TWO_SIDED|95.0|-1.7|0.1|||Mixed Models Analysis|||||0.1|-1.7|0.075
73985000|NCT02350127|147515173|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.7||0.35|TWO_SIDED|95.0|-1.7|5.0|||Mixed Models Analysis|||||5.0|-1.7|0.35
73985001|NCT02350127|147515174|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.35|TWO_SIDED|95.0|-6.1|2.1|||Mixed Models Analysis|||||2.1|-6.1|0.35
73985002|NCT02350127|147515175|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.54|TWO_SIDED|95.0|-0.4|0.8|||Mixed Models Analysis|||||0.8|-0.4|0.54
73985003|NCT02350127|147515176|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.69|TWO_SIDED|95.0|-1.5|2.2|||Mixed Models Analysis|||||2.2|-1.5|0.69
73985004|NCT02350127|147515177|SUPERIORITY||Median Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.2||0.88|TWO_SIDED|95.0|-10.9|9.3|||Mixed Models Analysis|||||9.3|-10.9|0.88
73985005|NCT02350127|147515178|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.26|TWO_SIDED|95.0|-0.7|2.5|||Mixed Models Analysis|||||2.5|-0.7|0.26
73985006|NCT02350127|147515179|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.1||0.08|TWO_SIDED|95.0|-3.9|0.2|||Mixed Models Analysis|||||0.2|-3.9|0.08
73985007|NCT01209936|147515195|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
73985008|NCT01209936|147515196|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
73985009|NCT01209936|147515197|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
73985010|NCT03418701|147515222|SUPERIORITY||Mean Difference (Final Values)|2.67|||<|0.05|TWO_SIDED|95.0|0.93|4.4|||t-test, 2 sided|||||4.40|0.93|<0.05
73985011|NCT03418701|147515223|SUPERIORITY||Odds Ratio, log|0.47|||<|0.05|TWO_SIDED|95.0|0.22|1.15|||Mixed Models Analysis|A multilevel logistic regression with participants nested within clinic.||||1.15|0.22|<0.05
73985012|NCT04281875|147515227|SUPERIORITY|||||||0.6905|||||||t-test, 2 sided|||||||0.6905
73985013|NCT02849509|147515245|OTHER||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||<0.0001
73985014|NCT02849509|147515245|OTHER|||||||0.0174||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0174
73985015|NCT02849509|147515246|OTHER||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||<0.0001
73985016|NCT02849509|147515246|OTHER|||||||0.0004||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0004
73985017|NCT02849509|147515247|OTHER|||||||0.0423||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0423
73985018|NCT02849509|147515247|OTHER|||||||0.2226||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.2226
73985019|NCT02849509|147515248|OTHER|||||||0.0287||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0287
74039547|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0006|TWO_SIDED|95.0|1.23|2.17|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.17|1.23|0.0006
73985020|NCT02849509|147515248|OTHER|||||||0.03||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0300
73985021|NCT02849509|147515254|OTHER|||||||0.1234||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.1234
73985022|NCT02849509|147515254|OTHER|||||||0.974||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.9740
73985023|NCT00985621|147515259|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.49|-0.44|||ANCOVA|||Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.44|-1.49|<0.001
73985024|NCT00985621|147515259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.43|||ANCOVA|||Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.43|-1.50|<0.001
73985025|NCT00985621|147515260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.49|-0.45|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.45|-1.49|<0.001
73985026|NCT00985621|147515260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.27||0.018|TWO_SIDED|95.0|-1.16|-0.11|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.11|-1.16|0.018
74034133|NCT01798706|147621224|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.262||0.2347|TWO_SIDED|95.0|-0.828|0.204||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline FPG value as a covariate.||0.204|-0.828|0.2347
74034134|NCT03238235|147621234|SUPERIORITY||Log Difference of the least square means|0.04||||0.8282|TWO_SIDED|95.0|-0.3|0.38||ANCOVA model was performed considering the difference between log of total fibrosis and log baseline values as dependent variable; log baseline value was included as covariate, treatment and concomitant steroid use as independent class variables.|ANCOVA|||total fibrosis at visit 11||0.38|-0.30|0.8282
74034135|NCT03238235|147621234|SUPERIORITY|Mixed model was performed considering the difference between log Visit 11 and log baseline values as dependent variable; log baseline as covariate, treatment was included as independent class variable and treatment by sequence interaction. The sequence of biopsy site (R-L, L-R) was included as a fixed effect and subject as a random effect. If the treatment by sequence interaction was p\>0.10, then the model without the interaction term is presented.|Log Difference of Least Square Means|-0.11||||0.6465|TWO_SIDED|95.0|-0.59|0.37|||Mixed Models Analysis|||A Mixed Model was fitted to the data in order to evaluate the difference in total fibrosis between biopsy sites||0.37|-0.59|0.6465
74089688|NCT00700817|147732159|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.63||||0.0001||95.0|-0.81|-0.44||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.8 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.||-0.44|-0.81|0.0001
73874872|NCT03726489|147291455|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.458|TWO_SIDED|95.0|0.471|1.403|||Regression, Cox|Failure event corresponds to DLQI assessment greater than 5. Model adjusted for skin phototype.|Office phototherapy is the reference group.|Cox proportional hazards model for maintaining treatment response after week 12.||1.403|0.471|0.458
73985027|NCT00985621|147515260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.7|TWO_SIDED|95.0|-0.43|0.65|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.65|-0.43|0.700
73985028|NCT00985621|147515261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.177|TWO_SIDED|95.0|-0.78|0.14|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.14|-0.78|0.177
73985029|NCT00985621|147515261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.24||0.416|TWO_SIDED|95.0|-0.66|0.28|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.28|-0.66|0.416
73985030|NCT00985621|147515261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.5|-0.46|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.46|-1.50|<0.001
73985031|NCT00985621|147515261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.48|-0.43|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.43|-1.48|<0.001
74034136|NCT03238235|147621235|SUPERIORITY||Log Difference of Least Square Means|-0.05||||0.1991|TWO_SIDED|95.0|-0.12|0.03||ANCOVA model was performed considering baseline fat fraction of vastus lateralis or fat fraction in the soleus value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Vastus lateralis||0.03|-0.12|0.1991
74034137|NCT03238235|147621235|SUPERIORITY||difference of the least square means|-0.27||||0.7849|TWO_SIDED|95.0|-2.22|1.69||ANCOVA model was performed considering baseline fat fraction of vastus lateralis or fat fraction in the soleus value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Soleus||1.69|-2.22|0.7849
74034138|NCT03238235|147621236|SUPERIORITY||Difference of Least Square Means|-1.35||||0.0149|TWO_SIDED|95.0|-2.43|-0.28||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole thigh at visit 11||-0.28|-2.43|0.0149
74034139|NCT03238235|147621236|SUPERIORITY||Difference of Least Square Means|-1.96||||0.0022|TWO_SIDED|95.0|-3.18|-0.75||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Quadriceps at visit 11||-0.75|-3.18|0.0022
74089689|NCT00700817|147732159|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.4||||0.0001||95.0|-0.59|-0.22||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.2 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.||-0.22|-0.59|0.0001
73985032|NCT00985621|147515262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.23||0.319|TWO_SIDED|95.0|-0.69|0.22|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.22|-0.69|0.319
73985033|NCT00985621|147515262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.23||0.916|TWO_SIDED|95.0|-0.43|0.48|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.48|-0.43|0.916
73985034|NCT00985621|147515262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.24||0.526|TWO_SIDED|95.0|-0.63|0.32|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.32|-0.63|0.526
73985035|NCT00985621|147515262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.26||0.004|TWO_SIDED|95.0|-1.26|-0.24|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.24|-1.26|0.004
73985036|NCT00985621|147515262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.26||0.134|TWO_SIDED|95.0|-0.9|0.12|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.12|-0.90|0.134
73985037|NCT00985621|147515262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.27||0.497|TWO_SIDED|95.0|-0.71|0.35|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.35|-0.71|0.497
73985038|NCT00257556|147515309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045||||||95.0|-0.17|0.26|||||A two-sided 95% continuity-corrected confidence interval for the difference in percentages, based on the normal approximation|||0.260|-0.170|
73985039|NCT04839289|147515335|OTHER||||||>|0.05||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||"Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||>0.05
73985040|NCT04839289|147515335|OTHER||||||<|0.0167||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||"Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.0167
73985041|NCT04839289|147515338|OTHER||||||<|0.01666667||||||When p-value is adjusted for multiple comparisons, the value must be \</= to .01666667 (.05/3).|t-test, 2 sided|||"Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.01666667
73985042|NCT04839289|147515338|OTHER||||||<|0.01666667||||||When adjusted for multiple comparisons, the p-value must be \</= to .01666667 (.05/3).|t-test, 2 sided|||"Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.01666667
74089690|NCT00700817|147732161|SUPERIORITY_OR_OTHER||Change within treatment group|-0.24|STANDARD_DEVIATION|0.7||0.006||95.0|-0.41|-0.07||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.||-0.07|-0.41|0.0060
73985043|NCT01207453|147515358|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed rank tests.||||0.42
73985044|NCT01207453|147515358|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.37
73985045|NCT01207453|147515359|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using the Wilcoxon signed-rank tests.||||0.39
74089691|NCT00700817|147732161|SUPERIORITY_OR_OTHER||Change within treatment group|-0.45|STANDARD_DEVIATION|0.9||0.0001||95.0|-0.67|-0.23||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.||-0.23|-0.67|0.0001
73985046|NCT01207453|147515359|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.96
73985047|NCT01207453|147515360|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.89
73985048|NCT01207453|147515360|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.83
73985049|NCT01207453|147515361|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.04
74034140|NCT03238235|147621236|SUPERIORITY||Difference of least square means|-0.58||||0.4869|TWO_SIDED|95.0|-2.24|1.08||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Hamstrings at visit 11||1.08|-2.24|0.4869
74034141|NCT03238235|147621236|SUPERIORITY||Difference of Least Square Means|-1.59||||0.0939|TWO_SIDED|95.0|-3.47|0.29||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Triceps Surae at Visit 11||0.29|-3.47|0.0939
74034142|NCT03238235|147621236|SUPERIORITY||Difference of Least Square Means|-0.89||||0.1579|TWO_SIDED|95.0|-2.13|0.36||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Pelvis girdle at visit 11||0.36|-2.13|0.1579
74034143|NCT03238235|147621237|SUPERIORITY||Difference of Least Square Means|0.4||||0.777|TWO_SIDED|95.0|-2.45|3.26||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole Thigh at visit 11||3.26|-2.45|0.7770
74034144|NCT03238235|147621237|SUPERIORITY||Difference of Least Square Means|-0.09||||0.8926|TWO_SIDED|95.0|-1.35|1.18||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Quadriceps at Visit 11||1.18|-1.35|0.8926
74034145|NCT03238235|147621237|SUPERIORITY||Difference of Least Square Means|0.35||||0.572|TWO_SIDED|95.0|-0.88|1.58||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Medial Thigh at Visit 11||1.58|-0.88|0.5720
74034146|NCT03238235|147621237|SUPERIORITY||Difference of Least Square Means|0.11||||0.8386|TWO_SIDED|95.0|-0.97|1.18||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Hamstrings at Visit 11||1.18|-0.97|0.8386
74034147|NCT03238235|147621237|SUPERIORITY||Difference of Least Square Means|-0.22||||0.8591|TWO_SIDED|95.0|-2.68|2.25||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Triceps Surae at Visit 11||2.25|-2.68|0.8591
74034148|NCT03238235|147621237|SUPERIORITY||Difference of Least Square Means|0.32||||0.7392|TWO_SIDED|95.0|-1.6|2.24|||ANCOVA|||Pelvis Girdle at Visit 11||2.24|-1.60|0.7392
73956255|NCT03441984|147448074|OTHER||Ratio of geometric LS means|1.6503|||||TWO_SIDED|90.0|1.5131|1.8|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8000|1.5131|
74034149|NCT03238235|147621238|SUPERIORITY||Difference of Least Square Means|1.37||||0.0375|TWO_SIDED|95.0|0.08|2.65||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole Thigh at Visit 11||2.65|0.08|0.0375
74034150|NCT03238235|147621238|SUPERIORITY||difference of least square means|0.63||||0.0528|TWO_SIDED|95.0|-0.01|1.27||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Quadriceps at Visit 11||1.27|-0.01|0.0528
74034151|NCT03238235|147621238|SUPERIORITY||Difference of Least Square Means|0.36||||0.2012|TWO_SIDED|95.0|-0.2|0.91||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Medial Thigh at Visit 11||0.91|-0.20|0.2012
74034152|NCT03238235|147621238|SUPERIORITY||Difference of Least Square Means|0.75||||0.4676|TWO_SIDED|95.0|-1.33|2.83||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Triceps Surae at Visit 11||2.83|-1.33|0.4676
74034153|NCT03238235|147621238|SUPERIORITY||Difference of Least Square Means|0.54||||0.1549|TWO_SIDED|95.0|-0.21|1.3||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Pelvis Girdle at Visit 11||1.30|-0.21|0.1549
74034154|NCT03238235|147621239|SUPERIORITY||Difference of Least Square Means|-619.2||||0.324|TWO_SIDED|95.0|-1872.37|633.98||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||CSA Type II at Visit 11||633.98|-1872.37|0.3240
74034155|NCT03238235|147621239|SUPERIORITY||Difference of Least Square Means|-572.54||||0.307|TWO_SIDED|95.0|-1690.73|545.64||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Total CSA at Visit 11||545.64|-1690.73|0.3070
74034156|NCT03238235|147621240|SUPERIORITY||Log Difference of Least Square Means|-0.27||||0.1055|TWO_SIDED|95.0|-0.59|0.06||ANCOVA model was performed considering baseline Biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Fibers with nuclear centralizations (%) at Visit 11||0.06|-0.59|0.1055
74034157|NCT03238235|147621240|SUPERIORITY||Difference of Least Square Means|-2.23||||0.8846|TWO_SIDED|95.0|-33.05|28.59||ANCOVA model was performed considering baseline biopsy histological parameters (Slide II) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Total number of fibers at Visit 11 (slide II)||28.59|-33.05|0.8846
74034158|NCT03238235|147621240|SUPERIORITY||Difference of Least Square Means|4.72||||0.4054|TWO_SIDED|95.0|-6.62|16.06||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Total number of fibers (Slide III)||16.06|-6.62|0.4054
73956256|NCT03441984|147448074|OTHER||Ratio of geometric LS means|1.3501|||||TWO_SIDED|90.0|1.2381|1.4722|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4722|1.2381|
74034159|NCT03238235|147621241|SUPERIORITY||Difference of Least Square Means|2.45||||0.634|TWO_SIDED|95.0|-7.87|12.77||ANCOVA model was performed considering baseline Biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||||12.77|-7.87|0.6340
74034160|NCT03238235|147621242|SUPERIORITY||Log Difference of Least Square Means|-0.14||||0.4893|TWO_SIDED|95.0|-0.54|0.26|||ANCOVA|||||0.26|-0.54|0.4893
74034161|NCT03238235|147621243|SUPERIORITY||Log Difference of Least Square Means|-0.34||||0.1498|TWO_SIDED|95.0|-0.81|0.13||This model was performed considering baseline biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||||0.13|-0.81|0.1498
73956257|NCT03441984|147448074|OTHER||Ratio of geometric LS means|1.2224|||||TWO_SIDED|90.0|1.121|1.333|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3330|1.1210|
73956258|NCT03441984|147448083|OTHER||Ratio of geometric LS means|1.0251|||||TWO_SIDED|90.0|0.848|1.2392|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.2392|0.8480|
73956259|NCT03441984|147448083|OTHER||Ratio of geometric LS means|0.9181|||||TWO_SIDED|90.0|0.7592|1.1103|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.1103|0.7592|
73956260|NCT03441984|147448083|OTHER||Ratio of geometric LS means|1.1165|||||TWO_SIDED|90.0|0.9376|1.3295|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) is presented|||1.3295|0.9376|
73956261|NCT03441984|147448091|OTHER||Ratio of geometric LS means|1.0844|||||TWO_SIDED|90.0|0.9904|1.1873|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.1873|0.9904|
73956262|NCT03441984|147448091|OTHER||Ratio of geometric LS means|1.1311|||||TWO_SIDED|90.0|1.0334|1.2379|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.2379|1.0334|
73956263|NCT03441984|147448091|OTHER||Ratio of geometric LS means|0.9587|||||TWO_SIDED|90.0|0.876|1.0493|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0493|0.8760|
73956264|NCT03441984|147448099|OTHER||Ratio of geometric LS means|1.5619|||||TWO_SIDED|90.0|1.3678|1.7835|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented|||1.7835|1.3678|
73956265|NCT03441984|147448099|OTHER||Ratio of geometric LS means|1.253|||||TWO_SIDED|90.0|1.0973|1.4307|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4307|1.0973|
73956266|NCT03441984|147448099|OTHER||Ratio of geometric LS means|1.2466|||||TWO_SIDED|90.0|1.0917|1.4234|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4234|1.0917|
73956267|NCT03441984|147448108|OTHER||Ratio of geometric LS means|1.0745|||||TWO_SIDED|90.0|0.9997|1.1549|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented|||1.1549|0.9997|
73956268|NCT03441984|147448108|OTHER||Ratio of geometric LS means|1.0706|||||TWO_SIDED|90.0|0.9961|1.1507|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.1507|0.9961|
73956269|NCT03441984|147448108|OTHER||Ratio of geometric LS means|1.0036|||||TWO_SIDED|90.0|0.9338|1.0787|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0787|0.9338|
73956270|NCT00517933|147448205|SUPERIORITY_OR_OTHER|||||||0.39|||||||Chi-squared|||||||0.39
73956271|NCT00517933|147448207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.11|TWO_SIDED|95.0|-3.9|37.3|||Regression, Linear|||||37.3|-3.9|0.11
73956272|NCT00517933|147448208|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Log Rank|||||||0.41
73956273|NCT00517933|147448209|SUPERIORITY_OR_OTHER||Slope|-6.58|STANDARD_ERROR_OF_MEAN|2.3||0.006|TWO_SIDED|95.0|-11.25|-1.92|||Mixed Models Analysis|||||-1.92|-11.25|0.006
73956274|NCT00517933|147448211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.7|TWO_SIDED|95.0|-0.05|0.07|||Mixed Models Analysis|||||0.07|-0.05|0.70
73956275|NCT00517933|147448213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.04|TWO_SIDED|95.0|0.1|3.0|||Mixed Models Analysis|||||3.0|0.1|0.04
73956276|NCT00517933|147448215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.16|TWO_SIDED|95.0|-0.81|0.14|||Regression, Linear|||||0.14|-0.81|0.16
73956277|NCT00517933|147448217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.01|TWO_SIDED|95.0|-7.3|-0.9|||Regression, Linear|||||-0.9|-7.3|0.01
73956278|NCT00517933|147448219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.02|TWO_SIDED|95.0|-10.6|-0.9|||Regression, Linear|||||-0.9|-10.6|0.02
73956279|NCT00517933|147448221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.04|TWO_SIDED|95.0|-7.2|-0.1|||Regression, Linear|||||-0.1|-7.2|0.04
73956280|NCT00517933|147448223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.07|TWO_SIDED|95.0|-7.8|0.4|||Regression, Logistic|||||0.4|-7.8|0.07
73956281|NCT00517933|147448225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.18|TWO_SIDED|95.0|-0.01|0.06|||Regression, Linear|||||0.06|-0.01|0.18
73956282|NCT00517933|147448227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.37|TWO_SIDED|95.0|-2.8|7.3|||Regression, Linear|||||7.3|-2.8|0.37
73956283|NCT00517933|147448231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.008|TWO_SIDED|95.0|0.8|5.0|||Regression, Linear|||||5.0|0.8|0.008
74034162|NCT03238235|147621244|SUPERIORITY||Log Difference of Least Square Means|0.06||||0.0602|TWO_SIDED|95.0|0.0|0.13||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Standing and transfers (D1) at Visit 11||0.13|-0.00|0.0602
73874873|NCT03726489|147291456|SUPERIORITY||Risk Difference (RD)|38.1|||<|0.0001|TWO_SIDED|95.0|30.34|45.86||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||45.86|30.34|<0.0001
74034163|NCT03238235|147621244|SUPERIORITY||Log Difference of Least Square Means|0.0||||0.5906|TWO_SIDED|95.0|-0.01|0.01||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Axial and proximal motor function (D2) at Visit 11||0.01|-0.01|0.5906
73956284|NCT00517933|147448233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.86|TWO_SIDED|95.0|-2.1|1.7|||Regression, Linear|||||1.7|-2.1|0.86
73956285|NCT01639443|147448292|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of percentage of clinic capacity filled. We are powered to detect a 0.5 Standard Deviation (SD) difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||<0.0001
73956286|NCT01639443|147448293|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||We calculated this measure on the patient level. Our null hypothesis is that the lag time between scheduling and appointment, measured in days, will not differ between groups. We are powered to detect a 0.3 SD difference in lag time (Type I error rate = 5%; Power = 84%), accounting for the large sampling ratio (approximately 14:1).||||0.29
73956287|NCT01639443|147448294|SUPERIORITY_OR_OTHER|||||||0.49||||||We would have only expected 2 patients to be bumped in the Experimental Group, and observed 0.|Fisher Exact|||We did not explicitly power this study to detect differences in the number of service bumps, but we can compare them using Fisher's Exact Test||||0.49
73956288|NCT01639443|147448295|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||We calculated this measure on the patient level, but were hampered by a large sampling ratio (more than 50:1). Our null hypothesis is that the number of polyps detected will not differ between groups. We are powered to detect a 0.25 SD difference in polyp count per patient (Type I error rate = 5%; Power = 80%).||||0.05
74039548|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.55|2.72|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.72|1.55|<.0001
73956289|NCT01639443|147448296|SUPERIORITY_OR_OTHER|||||||0.024|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of length of workday. We are powered to detect approximately 0.5 SD difference in workday length in hours (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||0.024
73956290|NCT01639443|147448297|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of cost per day. We are powered to detect a 0.5 SD difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||0.11
73956291|NCT01391013|147448330|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.08
73956292|NCT01391013|147448331|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.88
73956293|NCT01391013|147448332|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.31
73956294|NCT01391013|147448333|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.37
73956295|NCT01391013|147448334|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.66
73956296|NCT01391013|147448335|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.02
73956297|NCT01391013|147448336|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.12
73874874|NCT03726489|147291456|SUPERIORITY||Risk Difference (RD)|38.86|||<|0.0001|TWO_SIDED|95.0|27.39|50.33||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||50.33|27.39|<0.0001
73874875|NCT03726489|147291456|SUPERIORITY||Risk Difference (RD)|42.21|||<|0.0001|TWO_SIDED|95.0|30.73|53.68||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||53.68|30.73|<0.0001
74039549|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0387|TWO_SIDED|95.0|1.01|1.71|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|1.01|0.0387
74039550|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0903|TWO_SIDED|95.0|0.97|1.6|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.60|0.97|0.0903
73874876|NCT03726489|147291456|SUPERIORITY||Risk Difference (RD)|15.74||||0.234|TWO_SIDED|95.0|-9.63|41.11||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||41.11|-9.63|0.2340
73874877|NCT03726489|147291457|SUPERIORITY||Risk Difference (RD)|43.96|||<|0.0001|TWO_SIDED|95.0|37.25|50.66||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||50.66|37.25|<0.0001
73956298|NCT01391013|147448337|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.71
73956299|NCT01391013|147448338|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.83
73956300|NCT01391013|147448339|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.66
73956301|NCT01391013|147448340|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.76
73956302|NCT01391013|147448341|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.56
73956303|NCT01391013|147448342|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.11
73956304|NCT01391013|147448343|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.18
73956305|NCT01391013|147448344|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.03
73956306|NCT01391013|147448345|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.04
73956307|NCT00299702|147448361|SUPERIORITY_OR_OTHER|||||||0.684||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Log Rank|Insufficient number of subjects who had an event for median estimation.||Null hypothesis: there is no difference in time to relapse||||0.684
73956308|NCT00299702|147448362|SUPERIORITY_OR_OTHER|||||||0.646||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in time in remission between the two treatment groups||||0.646
73956309|NCT05460663|147448367|EQUIVALENCE|Paired Wilcoxon signed ranks tests were used to compare changes at 12-week, 18-week, or 24-week follow-ups from the baseline scores for all measurements in each training modality separately and combined. Comparisons were made with participants who had data at both baseline and the follow-up. Difference-in-difference comparison of changes between two training modalities at each follow-up from the baseline were made to assess differences between CBT and in-person training.||||||0.083||||||The reported P-value is for differences between groups at 24-weeks post-intervention.The Benjamini \& Hochberg adjustment was applied to control for the false-discovery rate among all pairwise pre-post comparisons.|Wilcoxon (Mann-Whitney)|||||||.083
73956310|NCT05273801|147448371|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||How frequently clinician ask about RPE/HR during session||||0.73
73956311|NCT05273801|147448371|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||How frequently education provided regarding HR/RPE during session||||0.05
73956312|NCT05273801|147448371|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||How frequently HR/RPE target is mentioned in session||||0.007
73956313|NCT05273801|147448371|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||How frequently clinician modifies session/task to reach HR/RPE target||||0.005
73956314|NCT05273801|147448371|SUPERIORITY|||||||1e-05|||||||t-test, 2 sided|||How frequently clinicians monitor HR/RPE during session||||0.00001
73956315|NCT00762463|147448406|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|LS mean difference calculated as LS mean change for Celecoxib 200 mg once daily minus LS mean change for Diclofenac SR 75 mg once daily. Non-inferiority was declared if the upper bound of the 95% confidence interval was \<10 mm.|LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.79||0.0085|TWO_SIDED|95.0|-2.2|8.8|||ANCOVA|Analysis of covariance (ANCOVA); factors: treatment group and study center; covariate: baseline Patient's Assessment of Global Pain Intensity score.||"Null hypothesis: Least Squares (LS) mean difference between Celecoxib 200 mg once daily versus Diclofenac SR 75 mg once daily on change in Global Pain Intensity from baseline to Week 6 was at least 10 mm. Corresponding alternative hypothesis: This difference was \<10 mm.~For the non-inferiority test, power was 80% and significance level was 0.025 (1-sided)."||8.8|-2.2|0.0085
73956316|NCT00762463|147448408|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.5||0.7849|TWO_SIDED|95.0|-5.6|4.2|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||4.2|-5.6|0.7849
73956317|NCT00762463|147448408|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.62||0.3223|TWO_SIDED|95.0|-2.6|7.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||7.8|-2.6|0.3223
73874878|NCT03726489|147291457|SUPERIORITY||Risk Difference (RD)|39.85|||<|0.0001|TWO_SIDED|95.0|30.0|49.7||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||49.70|30.0|<0.0001
73985050|NCT01207453|147515361|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.04
73985051|NCT01207453|147515362|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.89
73985052|NCT01207453|147515362|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.44
73985053|NCT01207453|147515363|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.35
73985054|NCT01207453|147515363|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.34
73985055|NCT01207453|147515364|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.72
73985056|NCT01207453|147515364|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.82
73985057|NCT00676663|147515367|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.06|TWO_SIDED|95.0|0.49|1.09|||Log Rank|P-value is stratified by the randomization stratification factors and is 1-sided, with a 0.10 threshold for significance.||||1.09|0.49|0.06
73985058|NCT00676663|147515371|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.018|TWO_SIDED|95.0|0.36|0.97||P-value is stratified by the randomization stratification factors and is 1-sided.|Log Rank||Hazard ratio was estimated from a Cox proportional hazards model. Placebo serves as the reference treatment group for the interpretation of the hazard ratio.|||0.97|0.36|0.018
73874879|NCT03726489|147291457|SUPERIORITY||Risk Difference (RD)|50.18|||<|0.0001|TWO_SIDED|95.0|40.09|60.27||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||60.27|40.09|<0.0001
73874880|NCT03726489|147291457|SUPERIORITY||Risk Difference (RD)|36.11|||<|0.0001|TWO_SIDED|95.0|14.35|57.87||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||57.87|14.35|<0.0001
73985059|NCT00580047|147515373|OTHER||||||||||||||||||The intervention groups were compared for compliance to either having annual IV zoledronic acid, taking weekly oral alendronate, and taking calcium/vitamin D supplementation.|||
73985060|NCT00513292|147515384|SUPERIORITY_OR_OTHER||difference in percentages between arms|2.3||||0.7|TWO_SIDED|95.0|-9.3|13.9|||Chi-squared|||The difference in pCR rates between treatment arms for pCR within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy||13.9|-9.3|.7
73985061|NCT01436045|147515393|SUPERIORITY_OR_OTHER||Percent Change|-15.7|STANDARD_ERROR_OF_MEAN|7.0|<|0.05|TWO_SIDED|||||RBANS Line Orientation|t-test, 2 sided||Response to intranasal Insulin Glulisine \[(result post-insulin - result post-placebo)/(result post-placebo)\] x 100%|Response to intranasal Insulin Gluiline \[(result post-insulin - result post-placebo)/(result post-placebo)\] x 100%||||<0.05
73985062|NCT01436045|147515396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.26|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Difference in errors \[result post-insulin - result post-placebo\]||||<0.05
73985063|NCT00635570|147515426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Chi-squared, Corrected|Yates's chi-squared test with 1 degree of freedom was used for analysis||The trial sample size of 300 participants total (150 participants each group) was based on two-sided 5% significance testing with 80% power to detect a difference of 10% in adherence between students in the contraceptive vaginal ring group and oral contraceptive pill group.||||0.05
73985064|NCT00635570|147515427|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|0.0|||||Chi-squared, Corrected|||||||>0.05
73985065|NCT00635570|147515428|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
73985066|NCT00635570|147515429|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
73985067|NCT00377312|147515445|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
74039551|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0006|TWO_SIDED|95.0|1.21|2.01|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.01|1.21|0.0006
73874881|NCT03726489|147291458|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-5.2||||0.1773|TWO_SIDED|95.0|-19.4|9.0||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||9.0|-19.4|0.1773
73874882|NCT03726489|147291458|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-6.88||||0.4073|TWO_SIDED|95.0|-26.09|12.33||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||12.33|-26.09|0.4073
73874883|NCT03726489|147291458|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-12.42||||0.8247|TWO_SIDED|95.0|-35.24|10.41||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||10.41|-35.24|0.8247
73874884|NCT03726489|147291458|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|37.88||||0.0133|TWO_SIDED|95.0|-4.01|79.77||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||79.77|-4.01|0.0133
73874885|NCT03726489|147291459|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|6.52||||0.002|TWO_SIDED|95.0|-7.11|20.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||20.14|-7.11|0.002
73874886|NCT03726489|147291459|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.77||||0.0137|TWO_SIDED|95.0|-10.35|25.89||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||25.89|-10.35|0.0137
73874887|NCT03726489|147291459|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|1.0||||0.1656|TWO_SIDED|95.0|-21.61|23.61||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||23.61|-21.61|0.1656
73874888|NCT03726489|147291459|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|22.73||||0.1225|TWO_SIDED|95.0|-25.16|70.62||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||70.62|-25.16|0.1225
73956318|NCT00762463|147448410|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.8938|TWO_SIDED|95.0|-0.15|0.17|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.17|-0.15|0.8938
73956319|NCT00762463|147448410|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0426|TWO_SIDED|95.0|0.01|0.31|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.31|0.01|0.0426
73956320|NCT00762463|147448410|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1502|TWO_SIDED|95.0|-0.05|0.29|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.29|-0.05|0.1502
73956321|NCT00762463|147448412|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.5945|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.1|-0.2|0.5945
73956322|NCT00762463|147448412|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.3427|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.1|0.3427
73956323|NCT00762463|147448412|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.6522|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.1|0.6522
73956324|NCT00762463|147448414|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.9358|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.3|0.9358
73956325|NCT00762463|147448414|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5916|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.5|-0.3|0.5916
73985068|NCT00377312|147515446|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
73985069|NCT00377312|147515447|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
73874889|NCT03726489|147291460|SUPERIORITY||Risk Difference (RD)|0.105||||0.0183|TWO_SIDED|95.0|0.018|0.192|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 16. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.192|0.018|0.0183
73985070|NCT00377312|147515448|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.01
73985071|NCT00377312|147515449|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05|TWO_SIDED|||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.05
73985072|NCT00377312|147515450|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002|TWO_SIDED|||||the reported p-value corresponds to the increase compared to baseline over time (days 2-8) in the PTH 2 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.002
73985073|NCT00377312|147515452|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.61
73985074|NCT00377312|147515453|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008|TWO_SIDED|||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.008
73985075|NCT00377312|147515453|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
73985076|NCT00377312|147515454|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
73985077|NCT00377312|147515454|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
73985078|NCT00377312|147515455|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
73985079|NCT00377312|147515455|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups||||||.01
74039552|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0166|TWO_SIDED|95.0|1.08|2.09|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.09|1.08|0.0166
74039553|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0001|TWO_SIDED|95.0|1.36|2.62|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.62|1.36|0.0001
73985080|NCT00377312|147515456|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||the reported p-value corresponds to % change compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>.05
74089692|NCT00279955|147732240|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.07|STANDARD_DEVIATION|0.292||0.0119|TWO_SIDED|95.0|1.17|3.67|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, New York Heart Association (NYHA) class at 6 month visit, Angiotensin Converting Enzyme (ACE)/Angiotensin Receptor Blocker (ARB) at 6 months, and Diuretics at 6 month.|||3.67|1.17|0.0119
74089693|NCT00279955|147732241|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.9|STANDARD_DEVIATION|0.277||0.0185|TWO_SIDED|95.0|1.11|3.27|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, NYHA class at 6 month visit, ACE/ARB at 6 months, and and at least one day where CRT pacing \<90% in last 21 days of DREP.|||3.27|1.11|0.0185
73985081|NCT03861429|147515475|SUPERIORITY||Odds Ratio (OR)|3.32||||0.105|TWO_SIDED|95.0|0.78|14.15|||Mixed Models Analysis|||Multilevel logistic regression (generalized estimating equations \[GEE\] with an autoregressive (1) working correlation matrix, logit link function) were fitted to assess the primary hypotheses. The models account for the repeated measures (3 or 4 time points), correlated, data structure per person. An additive model was conducted with contrast coding for each time point, treatment, and follow-up effects.||14.15|.78|.105
73985082|NCT03861429|147515476|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.04|TWO_SIDED|95.0|0.022|1.178|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||1.178|.022|.04
73985083|NCT03861429|147515477|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.001|TWO_SIDED|95.0|0.12|0.46|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.46|.12|.001
73985084|NCT03861429|147515478|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.001|TWO_SIDED|95.0|0.21|0.48|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.48|.21|.001
73985085|NCT03861429|147515479|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.081|TWO_SIDED|95.0|-0.01|0.19|||Mixed Models Analysis|||||.19|-.01|.081
73985086|NCT03861429|147515480|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.033|TWO_SIDED|95.0|0.11|0.3|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.3|.11|.033
73985087|NCT03327051|147515482|OTHER|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\<0.05.||||||0.04|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.||||0.04
73985088|NCT03327051|147515482|OTHER|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\<0.05.|||||>|0.99|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.||||>0.99
73985089|NCT01284634|147515493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.89|STANDARD_ERROR_OF_MEAN|5.454||0.222|TWO_SIDED|90.0|-16.35|2.56|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||2.56|-16.35|0.222
73985090|NCT01284634|147515493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.35|STANDARD_ERROR_OF_MEAN|5.943||0.133|TWO_SIDED|90.0|-19.66|0.95|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||0.95|-19.66|0.133
73985091|NCT01284634|147515493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|6.158||0.302|TWO_SIDED|90.0|-17.22|4.14|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||4.14|-17.22|0.302
74089694|NCT00279955|147732242|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8|STANDARD_DEVIATION|0.311||0.0578|TWO_SIDED|95.0|0.98|3.31|||Regression, Cox||A Cox regression model has been used here, and the estimated parameter has been adjusted by including covariates age, gender, and NYHA class at 6 months.|||3.31|0.98|0.0578
74089695|NCT01770431|147732245|SUPERIORITY||chi-squared|14.7315||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
74089696|NCT01770431|147732246|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.0001|TWO_SIDED|95.0|0.55|0.81|||Regression, Cox|||||0.81|0.55|<0.0001
74089697|NCT03545191|147732301|OTHER||LS mean difference to placebo|-12.2|||<|0.0001|TWO_SIDED|95.0|-17.435|-6.961||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 25 mg vs placebo).||-6.961|-17.435|<0.0001
73985092|NCT03334747|147515528|OTHER|||||||0.391|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||0.391
73985093|NCT03334747|147515528|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
73985094|NCT03334747|147515528|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
73985095|NCT03334747|147515528|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
73985096|NCT03334747|147515528|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
73985097|NCT03334747|147515528|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
73985098|NCT03334747|147515528|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
73985099|NCT03334747|147515528|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
73985100|NCT02567227|147515537|SUPERIORITY||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-3.6|1.54|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (Mild Cognitive Impairment (MCI) or cognitively normal) were used to compare changes in speed during normal pace walking pre and post intervention.||1.54|-3.60|
74034164|NCT03238235|147621244|SUPERIORITY||Log Difference of Least Square Means|0.0||||0.7799|TWO_SIDED|95.0|-0.01|0.01||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Distal motor function (D3) at Visit 11||0.01|-0.01|0.7799
74034165|NCT03238235|147621244|SUPERIORITY||Log Difference of Least Square Means|0.01||||0.1116|TWO_SIDED|95.0|0.0|0.03||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Total Score at Visit 11||0.03|-0.00|0.1116
74034166|NCT03238235|147621245|SUPERIORITY||Log Difference of Least Square Means|-0.07||||0.4346|TWO_SIDED|95.0|-0.23|0.1||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate|Mixed Models Analysis|||Time to Walk/Run 10 meters at Visit 11||0.10|-0.23|0.4346
73985101|NCT02567227|147515537|SUPERIORITY||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-2.59|3.76||P-values from linear mixed effects models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status|||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in speed during walking while talking pre and post intervention.||3.76|-2.59|
73985102|NCT02567227|147515538|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.49|0.2|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in SPPB scores pre and post intervention.||0.20|-0.49|
73985103|NCT02567227|147515539|SUPERIORITY||Mean Difference (Net)|0.83|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-2.13|3.79|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length during walking while talking pre and post intervention.||3.79|-2.13|
73985104|NCT02567227|147515539|SUPERIORITY||Mean Difference (Net)|-1.95|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED||||||||Estimates with standard errors are from linear mixed effect models.|Unadjusted linear mixed effects models were used to compare changes in stride length during normal walking pre and post intervention.||||
73985105|NCT02567227|147515540|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.91|0.43|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during normal walking pre and post intervention.||0.43|-0.91|
74034167|NCT03238235|147621246|SUPERIORITY||Log Difference of Least Square Means|-0.02||||0.8914|TWO_SIDED|95.0|-0.32|0.28|||Mixed Models Analysis|||Time to climb 4 standard steps (sec) at visit 11||0.28|-0.32|0.8914
74034168|NCT03238235|147621247|SUPERIORITY||Difference of Least Square Means|0.62||||0.7629|TWO_SIDED|95.0|-3.51|4.75||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Time to rise from floor at Visit 11||4.75|-3.51|0.7629
73874890|NCT03726489|147291460|SUPERIORITY||Risk Difference (RD)|0.064||||0.177|TWO_SIDED|95.0|-0.029|0.158|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 20. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.158|-0.029|0.177
73874891|NCT03726489|147291460|SUPERIORITY||Risk Difference (RD)|-0.011||||0.815|TWO_SIDED|95.0|-0.101|0.079|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 24. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.079|-0.101|0.815
73874892|NCT04057807|147291471|SUPERIORITY|||||||0.14|||||||unpaired t-tests (continuous variables)|||||||0.14
73874893|NCT04057807|147291472|SUPERIORITY|||||||0.82|||||||univariate linear regression analysis|two-tailed P value was obtained from a univariate linear regression analysis||||||0.82
73874894|NCT00786799|147291482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|STANDARD_DEVIATION|6.1||0.4|||||||t-test, 2 sided|||The null hypothesis is that the mean change in Aberrant Behavior Checklist Hyperactivity subscale (ABC-H) score is the same for both groups.||||0.40
73956326|NCT00762463|147448414|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.179|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.7|-0.1|0.1790
73956327|NCT00762463|147448416|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6335|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.5|-0.3|0.6335
73956328|NCT00762463|147448416|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2729|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.6|-0.2|0.2729
73956329|NCT00762463|147448416|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1559|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.8|-0.1|0.1559
73956330|NCT00762463|147448419|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|2.67||0.1111|TWO_SIDED|95.0|-1.0|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||9.5|-1.0|0.1111
73956331|NCT00762463|147448419|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.74||0.3574|TWO_SIDED|95.0|-2.9|7.9|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||7.9|-2.9|0.3574
73956332|NCT00762463|147448419|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.76||0.1464|TWO_SIDED|95.0|-1.4|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||9.5|-1.4|0.1464
73956333|NCT00762463|147448421|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.9641|TWO_SIDED|95.0|-1.7|1.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||1.8|-1.7|0.9641
73956334|NCT00762463|147448421|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7749|TWO_SIDED|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.2|-1.6|0.7749
73956335|NCT00762463|147448421|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.95||0.7529|TWO_SIDED|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.2|-1.6|0.7529
73956336|NCT00762463|147448423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11||0.878|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.2|0.8780
73956337|NCT00762463|147448423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.2202|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.1|0.2202
73956338|NCT00762463|147448423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.534|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.2|0.5340
73985106|NCT02567227|147515540|SUPERIORITY||Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.16|0.27|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during walking while talking pre and post intervention.||0.27|-1.16|
73985107|NCT02567227|147515541|SUPERIORITY||Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.51|0.19|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during normal pace walking pre and post intervention.||0.19|-0.51|
73985108|NCT02567227|147515541|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.2|0.41|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during normal pace walking pre and post intervention.||0.41|-0.20|
73985109|NCT02567227|147515541|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.53|0.32|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during normal pace walking pre and post intervention.||0.32|-0.53|
73985110|NCT02567227|147515541|SUPERIORITY||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.27|0.56|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during walking while talking pre and post intervention.||0.56|-0.27|
73985111|NCT02567227|147515541|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.48|0.45|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during walking while talking pre and post intervention.||0.45|-0.48|
73985112|NCT02567227|147515541|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.4|0.35|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during walking while talking pre and post intervention.||0.35|-0.40|
73985113|NCT02567227|147515542|SUPERIORITY||Odds Ratio (OR)|0.925|||||TWO_SIDED|95.0|0.369|2.319||||||Logistic model for treatment effect on substantial improvement in normal velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).||2.319|0.369|
73985114|NCT02567227|147515542|SUPERIORITY||Odds Ratio (OR)|0.961|||||TWO_SIDED|95.0|0.516|1.789||||||Logistic model for treatment effect on substantial improvement in walking while talking velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).||1.789|0.516|
73985115|NCT02567227|147515543|SUPERIORITY||Mean Difference (Net)|-7.52|STANDARD_ERROR_OF_MEAN|14.17|||TWO_SIDED|95.0|-35.45|20.41|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in Flanker performance (milliseconds) pre and post intervention.||20.41|-35.45|
74034169|NCT03238235|147621248|SUPERIORITY||Log Difference of Least Square Means|-0.01||||0.8106|TWO_SIDED|95.0|-0.11|0.08||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate|Mixed Models Analysis|||Maximum distance walked after 6 minutes at Visit 11||0.08|-0.11|0.8106
74034170|NCT03238235|147621249|SUPERIORITY|||||||0.1626||||||P-value is obtained from the two-sided Cochran-Mantel-Haenszel chi-squared test, stratified for concomitant steroid use at baseline|Cochran-Mantel-Haenszel|||\<10% worsening at visit 11||||0.1626
74034171|NCT03238235|147621252|SUPERIORITY||Difference of Least Square Means|3.57||||0.5099|TWO_SIDED|95.0|-7.27|14.41||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Left Knee Extension (N) at Visit 11||14.41|-7.27|0.5099
74034172|NCT03238235|147621252|SUPERIORITY||Difference of Least Square Means|1.16||||0.7355|TWO_SIDED|95.0|-5.73|8.06||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Right Knee Extension (N) at Visit 11||8.06|-5.73|0.7355
74034173|NCT03238235|147621252|SUPERIORITY||Difference of Least Square Means|3.92||||0.6037|TWO_SIDED|95.0|-11.22|19.06||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Left Elbow Flexion (N) at Visit 11||19.06|-11.22|0.6037
74034174|NCT03238235|147621252|SUPERIORITY||Difference of Least Square Means|4.1||||0.6178|TWO_SIDED|95.0|-12.35|20.55||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Right Elbow Flexion (N) at Visit 11||20.55|-12.35|0.6178
73985116|NCT02567227|147515544|SUPERIORITY||Mean Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-0.3|2.31|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes on the Digit Symbol Substitution Test pre and post intervention.||2.31|-0.30|
73985117|NCT02567227|147515545|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare performance on Trail Making Test form A pre and post intervention.||||
73985118|NCT02567227|147515546|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.07|0.06|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in performance on Trail Making Test form B pre and post intervention.||0.06|-0.07|
73985119|NCT02567227|147515547|SUPERIORITY||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.86|2.2|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes performance on the Controlled Oral Word Association Test pre and post intervention.||2.20|-0.86|
73985120|NCT02567227|147515550|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|-1.65|3.91|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during normal walking pre and 6 months post intervention.||3.91|-1.65|
73985121|NCT02567227|147515550|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|-2.12|4.91|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during walking while talking pre and 6 months post intervention.||4.91|-2.12|
73985122|NCT02567227|147515551|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare changes in stair climbing time pre and post intervention.||||
73985123|NCT02567227|147515552|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare changes in activities of daily living pre and post intervention.||||
74034175|NCT03238235|147621255|SUPERIORITY||log difference of Least Square Means|-0.03||||0.1165|TWO_SIDED|95.0|-0.06|0.01||ANCOVA model was performed considering baseline fat fraction of lower limb muscles value as covariate and treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Medial Thigh at visit 11||0.01|-0.06|0.1165
73985124|NCT02567227|147515553|SUPERIORITY||Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.4|0.93|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in depressive symptoms measured using the GDS pre and post intervention.||0.93|-0.40|
74034176|NCT03238235|147621256|SUPERIORITY||Log difference of Least Square Means|0.05||||0.1939|TWO_SIDED|95.0|-0.02|0.12||ANCOVA model was performed considering baseline CSA as covariate and treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Hamstrings at Visit 11||0.12|-0.02|0.1939
73985125|NCT02567227|147515555|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.38|2.16|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in reported fear of falling measured on the Falls Efficacy Scale pre and post intervention.||2.16|-1.38|
73985126|NCT02567227|147515556|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.46|1.04|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the physical health score of the SF-12 pre and post intervention.||1.04|-1.46|
73985127|NCT02567227|147515556|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.04|1.85|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the mental health score of the SF-12 pre and post intervention.||1.85|-1.04|
73985128|NCT02137239|147515563|SUPERIORITY||Incidence of Change|-1.7|||||TWO_SIDED|95.0|-18.9|16.7||||||Change in Incidence of Treatment A as compared to Treatment B at 6 Months||16.7|-18.9|
73985129|NCT02137239|147515563|SUPERIORITY||Incidence of Change|-1.0|||||TWO_SIDED|95.0|-19.2|18.9||||||Change in Incidence of Treatment A as compared to Treatment B at 12 Months||18.9|-19.2|
73985130|NCT02137239|147515563|SUPERIORITY||Incidence of Change|2.9|||||TWO_SIDED|95.0|-16.1|23.9||||||Change in Incidence of Treatment A as compared to Treatment B at 24 Months||23.9|-16.1|
73985131|NCT02498418|147515599|EQUIVALENCE|Bioequivalence was demonstrated if 90% confidence interval (CI) of percentage difference between generic rifaximin 200 mg tablets and xifaxan 200 mg tablets was within the equivalence range (-20%, +20%).|Difference in percentage of participants|-0.0193|||||TWO_SIDED|90.0|-0.11|0.07||||||Bioequivalence was evaluated based on the PP analysis set using Z-test with Yates correction.||0.07|-0.11|
73985132|NCT02498418|147515602|SUPERIORITY||Difference in percentage of participants|-0.0195||||0.7899|TWO_SIDED|95.0|-0.09|0.13||Threshold of significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates' correction.||0.13|-0.09|0.7899
73985133|NCT02498418|147515602|SUPERIORITY||Difference in percentage of participants|0.033||||0.5987|TWO_SIDED|95.0|-0.07|0.14||Threshold for significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates' correction.||0.14|-0.07|0.5987
74034177|NCT03238235|147621257|SUPERIORITY||Log difference of Least Square Means|0.01||||0.9493|TWO_SIDED|95.0|-0.29|0.3||ANCOVA model was performed considering baseline biopsy histological parameters (slide III) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||CSA Type I||0.30|-0.29|0.9493
73985134|NCT03042559|147515607|SUPERIORITY|||||||||||||a priori threshold for statistical significance is \<0.05.|Wilcoxon (Mann-Whitney)|||Data analysis was performed using SPSS Statistics Software version 24.0. We compared mean age (years), Body Mass Index (kg/m2) (BMI), pain duration, and the outcome measures at baseline in both groups at baseline using independent t-test when the distribution of the variable was approximately normal and Mann-Whitney test when the distribution was not normal. The distribution of qualitative variables (gender, affected leg) by group type was examined using Chi Square test.|a priori threshold for statistical significance is \<0.05.|||
74034178|NCT03238235|147621258|SUPERIORITY||Log difference of Least Square Means|0.05||||0.6265|TWO_SIDED|95.0|-0.16|0.26||ANCOVA model was performed considering baseline biopsy histological parameters (slide I) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Total number of Fibers at Visit 11 (slide I)||0.26|-0.16|0.6265
74034179|NCT03238235|147621258|SUPERIORITY||Log difference of Least Square Means|-0.44||||0.1562|TWO_SIDED|95.0|-1.05|0.17||ANCOVA model was performed considering baseline biopsy histological parameters (slide II) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Regenerative Fibers (%) at Visit 11||0.17|-1.05|0.1562
73985135|NCT03042559|147515614|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73985136|NCT00385697|147515648|SUPERIORITY||Odds Ratio (OR)|0.963||||0.904|TWO_SIDED|95.0|0.521|1.779|||Mantel Haenszel|||||1.779|0.521|0.904
73985137|NCT00385697|147515648|SUPERIORITY||Odds Ratio (OR)|0.629||||0.222|TWO_SIDED|95.0|0.297|1.33|||Mantel Haenszel|||||1.330|0.297|0.222
73985138|NCT00385697|147515648|SUPERIORITY||Odds Ratio (OR)|1.054||||0.885|TWO_SIDED|95.0|0.521|2.129|||Mantel Haenszel|||||2.129|0.521|0.885
73985139|NCT00385697|147515650|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.814|TWO_SIDED|95.0|-0.45|0.572|||ANCOVA|||||0.572|-0.450|0.814
73985140|NCT00385697|147515650|SUPERIORITY||Mean Difference (Final Values)|0.161||||0.593|TWO_SIDED|95.0|-0.433|0.755|||ANCOVA|||||0.755|-0.433|0.593
73985141|NCT00385697|147515650|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.886|TWO_SIDED|95.0|-0.594|0.513|||ANCOVA|||||0.513|-0.594|0.886
73985142|NCT00385697|147515652|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.049|TWO_SIDED|95.0|0.0|0.093|||ANCOVA|||||0.093|0.000|0.049
73985143|NCT00385697|147515652|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.937|TWO_SIDED|95.0|-0.061|0.056|||ANCOVA|||||0.056|-0.061|0.937
73985144|NCT00385697|147515652|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.382|TWO_SIDED|95.0|-0.032|0.084|||ANCOVA|||||0.084|-0.032|0.382
73985145|NCT00385697|147515654|SUPERIORITY||Odds Ratio (OR)|0.881||||0.775|TWO_SIDED|95.0|0.372|2.089|||Mantel Haenszel|||||2.089|0.372|0.775
74034180|NCT01318083|147621262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.936|||||TWO_SIDED|95.0|-1.097|-0.775||||||||-0.775|-1.097|
74034181|NCT01318083|147621262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.998|||||TWO_SIDED|95.0|-1.16|-0.837||||||||-0.837|-1.160|
74034182|NCT01318083|147621263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.196|||||TWO_SIDED|95.0|-0.261|-0.131||||||||-0.131|-0.261|
74034183|NCT01318083|147621263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|||||TWO_SIDED|95.0|-0.273|-0.154||||||||-0.154|-0.273|
74034184|NCT01318083|147621264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.507|-0.312||||||||-0.312|-0.507|
73874895|NCT00287222|147291498|SUPERIORITY_OR_OTHER||percentage progression free at 27 weeks|28.0|STANDARD_ERROR_OF_MEAN|10.97||0.0006|TWO_SIDED|95.0|10.0|53.0|||one-sided exact binomial test|||Estimating the percentage of participants that remain free of disease progression at 27 weeks from the onset of treatment, and testing that proportion against a null-hypothesis proportion of 0.04 using the one-sided exact binomial test at 5% alpha, based upon historical data from the literature.||53|10|0.0006
73874896|NCT01284517|147291513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.08||0.176|||||||Mixed Models Analysis|||Null hypothesis (H0) assumes equal values between analysis groups in mean change from baseline in MADRS score, alternative hypothesis (HA) assumes unequal values between groups. Sample size determined by two-sample t-test. A mean difference of 3.25 units in change in MADRS score for the Lurasdone 20-120 mg arm over placebo with common standard deviation of 9 units was used. N=162 subjects per arm (total N=324) yields power of 90%. A 5% adjustment for drop-outs gives N=340, or N=170 per arm.||||0.176
73874897|NCT01284517|147291514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.141||0.095|||||||Mixed Models Analysis|||||||0.095
73985146|NCT00385697|147515654|SUPERIORITY||Odds Ratio (OR)|0.628||||0.402|TWO_SIDED|95.0|0.212|1.861|||Mantel Haenszel|||||1.861|0.212|0.402
73985147|NCT00385697|147515654|SUPERIORITY||Odds Ratio (OR)|1.093||||0.859|TWO_SIDED|95.0|0.41|2.912|||Mantel Haenszel|||||2.912|0.410|0.859
73985148|NCT00385697|147515656|SUPERIORITY||Odds Ratio (OR)|1.265||||0.404|TWO_SIDED|95.0|0.727|2.2|||Mantel Haenszel|||||2.200|0.727|0.404
73985149|NCT00385697|147515656|SUPERIORITY||Odds Ratio (OR)|0.805||||0.528|TWO_SIDED|95.0|0.412|1.576|||Mantel Haenszel|||||1.576|0.412|0.528
73985150|NCT00385697|147515656|SUPERIORITY||Odds Ratio (OR)|1.133||||0.706|TWO_SIDED|95.0|0.594|2.164|||Mantel Haenszel|||||2.164|0.594|0.706
73985151|NCT00385697|147515658|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.872|TWO_SIDED|95.0|-0.455|0.536|||ANCOVA|||||0.536|-0.455|0.872
73874898|NCT01284517|147291515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.0||0.992|||||||ANCOVA|||||||0.992
73874899|NCT00040443|147291516|OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|1.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<.05
73874900|NCT02485561|147291533|SUPERIORITY||F-value|1.019||||0.362|TWO_SIDED||||||ANOVA|||||||.362
73874901|NCT02485561|147291534|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.098||0.024|TWO_SIDED||||||t-test, 2 sided|||||||.024
73874902|NCT02485561|147291534|SUPERIORITY||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.074||0.75|TWO_SIDED||||||t-test, 2 sided|||||||.75
73874903|NCT02485561|147291535|SUPERIORITY||F-value|6.482||||0.002|TWO_SIDED||||||ANOVA|||||||.002
73874904|NCT02485561|147291535|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.91|TWO_SIDED||||||t-test, 2 sided|||||||.91
73874905|NCT02485561|147291535|SUPERIORITY||Mean Difference (Final Values)|0.716|STANDARD_ERROR_OF_MEAN|0.182|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
73874906|NCT02485561|147291536|SUPERIORITY||F-value|0.608||||0.55|TWO_SIDED||||||ANOVA|||||||0.55
73874907|NCT02485561|147291537|SUPERIORITY||F-value|16.31|||<|0.001|TWO_SIDED||||||ANOVA|||||||<.001
73985152|NCT00385697|147515658|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.979|TWO_SIDED|95.0|-0.581|0.556|||ANCOVA|||||0.556|-0.581|0.979
73985153|NCT00385697|147515658|SUPERIORITY||Mean Difference (Final Values)|-0.225||||0.4|TWO_SIDED|95.0|-0.75|0.301|||ANCOVA|||||0.301|-0.750|0.400
73985154|NCT01485991|147515660|SUPERIORITY_OR_OTHER||Difference in proportions|-1.1||||0.001|TWO_SIDED|95.0|-7.8|5.5||based on the asymptotic distribution of the generalized Cochran-Mantel-Haenszel statistic controlling for stratification factors, using a non-inferiority margin of 12 percent|Stratified Cochran-Mantel-Haenszel|||||5.5|-7.8|0.001
73985155|NCT04864236|147515678|EQUIVALENCE|We compared particle number counts between intervention and control groups using the Wilcoxon test. Analyses were conducted using IBM SPSS V28 and p-values \<0.05 were considered statistically significant.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985156|NCT04864236|147515679|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.073|||||||t-test, 1 sided|||||||0.073
73985157|NCT04864236|147515680|EQUIVALENCE|Patient characteristics and study variables were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.67|||||||t-test, 1 sided|||||||0.670
73985158|NCT04864236|147515681|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.167|||||||t-test, 1 sided|||||||0.167
73985159|NCT04864236|147515682|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.198|||||||t-test, 1 sided|||||||0.198
73985160|NCT04864236|147515683|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.442|||||||t-test, 1 sided|||||||0.442
73985161|NCT00577096|147515857|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of RBC transfusions.||||<0.025
73985162|NCT00577096|147515858|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis is that there was no difference in the number of RBC tranfusions in the exercise versus usual care groups. Data was combined from the short and long term RBC transfusions.||||<0.025
73985163|NCT00577096|147515859|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared test to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|Analysis included short and long term participants.||||||<0.025
73985164|NCT00577096|147515860|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.||||<0.025
74034185|NCT01318083|147621264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.453|||||TWO_SIDED|95.0|-0.547|-0.358||||||||-0.358|-0.547|
73985165|NCT00577096|147515861|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||||||<0.025
73985166|NCT00577096|147515862|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of stem cell collection attempts.||||<0.025
73985167|NCT00577096|147515863|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.||||<0.025
73985168|NCT00577096|147515864|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.||||<0.025
73985169|NCT00577096|147515865|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.||||<0.025
73985170|NCT00832650|147515867|SUPERIORITY_OR_OTHER||LS Mean difference|0.051|||||TWO_SIDED|95.0|-0.334|0.436|||ANCOVA||Least squares mean was calculated based on the ANCOVA model with treatment group as a fixed effect and baseline values, age and Body Mass Index (BMI) as covariates.|Null H10: μF8mg=μS10mg where μF8mg and μS10mg are means of GC24 for fesoterodine 8mg and solifenacin 10mg, respectively.||0.436|-0.334|
73985171|NCT01370564|147515898|OTHER|There was no specific hypothesis tested. The method of Rao and Scott for clustered binary data was used to construct a point estimate and 95% confidence interval for the number of days during the follow-up period across all subjects in which the patient instruction set was based on the subject's pressure state as measured by the Chronicle IHM/ICD system.|Rao-Scott estimator for clustered data|72.0|||||TWO_SIDED|95.0|65.0|78.0||||||||78|65|
73985172|NCT02418819|147515933|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-1.9|STANDARD_ERROR_OF_MEAN|2.032||0.8243|ONE_SIDED|92.0|-4.78||||ANCOVA|One(1)-sided P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-4.78|0.8243
73985173|NCT02418819|147515933|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-2.14|STANDARD_ERROR_OF_MEAN|2.252||0.8277|ONE_SIDED|92.0|-5.33||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-5.33|0.8277
73985174|NCT02418819|147515933|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-4.01|STANDARD_ERROR_OF_MEAN|1.902||0.981|ONE_SIDED|92.0|-6.7||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-6.70|0.9810
73985175|NCT02418819|147515934|SUPERIORITY_OR_OTHER||LSMean difference from placebo|0.0129|STANDARD_ERROR_OF_MEAN|0.286||0.4821|ONE_SIDED|99.0|-0.6682||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.6682|0.4821
73985176|NCT02418819|147515934|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-0.2974|STANDARD_ERROR_OF_MEAN|0.276||0.8576|ONE_SIDED|99.0|-0.9547||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.9547|0.8576
73985177|NCT02418819|147515934|SUPERIORITY_OR_OTHER||LSMean difference from placebo|0.0498|STANDARD_ERROR_OF_MEAN|0.2403||0.4182|ONE_SIDED|99.0|-0.5226||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.5226|0.4182
73985178|NCT00390806|147515942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.1862|TWO_SIDED|95.0|0.73|1.07||p-value from a stratified log-rank test is adjusted for Recursive Partitioning Analysis (RPA) class and the number of brain lesions at Screening.|Log Rank||The hazard ratio is estimated using a Pike estimator. The hazard ratio from a stratified log-rank test is adjusted for RPA class and the number of brain lesions at Screening.|||1.07|0.73|0.1862
73985179|NCT00714688|147515973|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-2.7|STANDARD_ERROR_OF_MEAN|1.51||0.136||95.0|-6.04|0.67||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||0.67|-6.04|0.136
73985180|NCT00714688|147515973|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.9|STANDARD_ERROR_OF_MEAN|1.5||0.002||95.0|-8.22|-1.55||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||-1.55|-8.22|0.002
73985181|NCT00714688|147515974|SUPERIORITY_OR_OTHER|||||||0.216||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model was performed on ranked data. Treatment, gender \& country were used as factors and baseline value \& age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.216
73985182|NCT00714688|147515974|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender \& country were used as factors and baseline value \& age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||<0.001
73985183|NCT00714688|147515975|SUPERIORITY_OR_OTHER|||||||0.052||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.||||||0.052
73874908|NCT02485561|147291537|SUPERIORITY||F-value|2.0||||0.14|TWO_SIDED||||||ANOVA|||||||0.14
73874909|NCT02485561|147291538|SUPERIORITY||F-value|1.68||||0.19|TWO_SIDED||||||ANOVA|||||||.19
73985184|NCT00714688|147515975|SUPERIORITY_OR_OTHER|||||||0.002||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.||||||0.002
73985185|NCT00714688|147515976|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.2|STANDARD_ERROR_OF_MEAN|1.86||0.023||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.023
73985186|NCT00714688|147515976|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.4|STANDARD_ERROR_OF_MEAN|1.83||0.016||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.016
73985187|NCT00925288|147515983|NON_INFERIORITY_OR_EQUIVALENCE|Since the standard schedule is at (0, 2, 6 months), and the modified schedule at (0, 3, 6 months), we will consider this a non-inferiority study. With 80% power, type 1 error of 0.05, standard deviations of 0.6, and an equivalence margin of 0.3, 64 women are needed per group to detect non-inferiority. Having 100 women in each study arm will yield over 94% power to detect non-inferiority of the modified schedule.|||||>|0.2||95.0|||||Regression, Logistic|||The null hypothesis is that both schedules will provide an equivalent antibody response.||||>0.20
73985188|NCT00925288|147515984|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Chi-squared|||Completion rates compared in the 2 study arms||||0.60
73985189|NCT00925288|147515985|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Chi-squared|||comparison of differences in HPV DNA prevalence by study arm.||||0.53
73985190|NCT00332488|147516001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.42|TWO_SIDED|95.0|-0.11|0.27|||ANCOVA|||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate||0.27|-0.11|0.420
73985191|NCT00332488|147516002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|||<|0.001|TWO_SIDED|95.0|0.69|1.14|||ANCOVA|Type III||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate||1.14|0.69|< 0.001
73985192|NCT02507687|147516005|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0231|TWO_SIDED|95.0|-1.03|-0.08|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||-0.08|-1.03|0.0231
73985193|NCT02507687|147516006|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.1615|TWO_SIDED|95.0|-1.04|0.18|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||0.18|-1.04|0.1615
73874910|NCT02485561|147291538|SUPERIORITY||F-value|0.021||||0.98|TWO_SIDED||||||ANOVA|||||||.98
73874911|NCT02485561|147291538|SUPERIORITY||F-value|0.312||||0.73|TWO_SIDED||||||ANOVA|||||||.73
73874912|NCT02485561|147291538|SUPERIORITY||F-value|0.702||||0.496|TWO_SIDED||||||ANOVA|||||||.496
73874913|NCT02485561|147291538|SUPERIORITY||F-value|1.88||||0.154|TWO_SIDED||||||ANOVA|||||||.154
73874914|NCT02485561|147291538|SUPERIORITY||F-value|0.667||||0.514|TWO_SIDED||||||ANOVA|||||||.514
73874915|NCT02485561|147291538|SUPERIORITY||F-value|0.666||||0.514|TWO_SIDED||||||ANOVA|||||||.514
73874916|NCT02485561|147291539|SUPERIORITY||F-value|0.59||||0.56|TWO_SIDED||||||ANOVA|||||||.56
73874917|NCT02485561|147291540|SUPERIORITY||F-value|0.18||||0.84|TWO_SIDED||||||ANOVA|||||||.84
73874918|NCT02485561|147291541|SUPERIORITY||F-value|1.16||||0.31|TWO_SIDED||||||ANOVA|||||||.31
73874919|NCT02485561|147291542|SUPERIORITY||F-value|1.17||||0.31|TWO_SIDED||||||ANOVA|||||||.31
73874920|NCT02485561|147291542|SUPERIORITY||F-value|0.056||||0.95|TWO_SIDED||||||ANOVA|||||||.95
73956339|NCT00762463|147448425|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.81||0.7003|TWO_SIDED|95.0|-4.3|2.9|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.9|-4.3|0.7003
73956340|NCT00762463|147448427|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|2.221||0.5183|TWO_SIDED|95.0|-5.82|2.94|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.94|-5.82|0.5183
73985194|NCT02507687|147516007|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.1673|TWO_SIDED|95.0|-0.97|0.17|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||0.17|-0.97|0.1673
73985195|NCT05372913|147516018|NON_INFERIORITY|The non-inferiority (NI) test for the secondary outcome (i.e., PHQ-8 Week 4 EOT score) was assessed using the pre-specified NI margin of 2.0. NI of W-GenZD to CBT-Lite was declared if the upper bound of the one-sided 97.5% confidence interval (CI) was less than 2.|Mean Difference (Net)|-0.67|||||TWO_SIDED|95.0|-2.3|0.96||||||||0.96|-2.30|
74034186|NCT01318083|147621265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.695|||||TWO_SIDED|95.0|-0.834|-0.556||||||||-0.556|-0.834|
74034187|NCT01318083|147621265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-0.911|-0.629||||||||-0.629|-0.911|
74034188|NCT01318083|147621266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.71|||||TWO_SIDED|95.0|-24.6|-10.83||||||||-10.83|-24.60|
74034189|NCT01318083|147621266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.59|||||TWO_SIDED|95.0|-24.93|-10.25||||||||-10.25|-24.93|
74034190|NCT01318083|147621267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.17|||||TWO_SIDED|95.0|-30.33|-16.02||||||||-16.02|-30.33|
74034191|NCT01318083|147621267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.88|||||TWO_SIDED|95.0|-32.33|-17.43||||||||-17.43|-32.33|
74034192|NCT01318083|147621268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.62|||||TWO_SIDED|95.0|-35.32|-19.91||||||||-19.91|-35.32|
74034193|NCT01318083|147621268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.72|||||TWO_SIDED|95.0|-30.76|-14.69||||||||-14.69|-30.76|
73956341|NCT01743729|147448432|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.03||||0.6186|TWO_SIDED|95.0|-0.1|0.17|||ANCOVA|||||0.17|-0.10|0.6186
73956342|NCT01743729|147448433|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|12.61|||<|0.0001|TWO_SIDED|95.0|8.51|16.7|||ANCOVA|||||16.70|8.51|<0.0001
73956343|NCT01306331|147448434|NON_INFERIORITY|If the upper bound for the confidence interval of the difference was \< 5.5, then the null hypothesis would be rejected.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.2|3.2||||||The primary hypothesis test was performed using 95% confidence interval for the difference in cumulative pregnancy rates between the treatment arms. If the upper bound for the confidence interval of the difference was \< 5.5, then the null hypothesis would be rejected.||3.2|-2.2|
74034194|NCT01318083|147621269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.37|||||TWO_SIDED|95.0|-37.14|-19.59||||||||-19.59|-37.14|
74034195|NCT01318083|147621269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.93|||||TWO_SIDED|95.0|-30.33|-13.54||||||||-13.54|-30.33|
74034196|NCT01318083|147621270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.41|||||TWO_SIDED|95.0|-36.58|-10.23||||||||-10.23|-36.58|
74034197|NCT01318083|147621270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.18|||||TWO_SIDED|95.0|-33.4|-4.95||||||||-4.95|-33.40|
74034198|NCT05896761|147621271|OTHER||Ratio of geometric least square mean|0.926|||||TWO_SIDED|90.0|0.831|1.03||||||||1.03|0.831|
74034199|NCT05896761|147621271|OTHER||Ratio of geometric least square mean|0.929|||||TWO_SIDED|90.0|0.816|1.06||||||||1.06|0.816|
73956344|NCT01677936|147448456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||=|0.024||||||Compared to snacks, raisins reduced percent post-prandial glucose levels by 23%, which met the a priori threshold for statistical significance.|t-test, 2 sided|||||||=0.024
73956345|NCT01677936|147448457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||=|0.035||||||Compared with snacks, the 8.8 mmHg reduction with raisins met the a priori threshold for statistical significance.|t-test, 2 sided|||||||=0.035
73956346|NCT00151996|147448489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score||||<0.0001
73956347|NCT00151996|147448489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score||||<0.0001
73956348|NCT00151996|147448491|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in CPRS-R total score||||<0.0001
73956349|NCT00151996|147448491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||t-test, 2 sided|||Change from baseline in CPRS-R total score||||0.0002
73956350|NCT00151996|147448493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7004||95.0|||||t-test, 2 sided|||Change in physical summary score||||0.7004
73956351|NCT00151996|147448493|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change in psychosocial summary score||||<0.0001
73956352|NCT00151996|147448493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9257||95.0|||||t-test, 2 sided|||Change in physical summary score||||0.9257
73956353|NCT00151996|147448493|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change in psychosocial summary score||||<0.0001
73956354|NCT01549314|147448494|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.77
73956355|NCT01549314|147448494|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.82
73956356|NCT01549314|147448495|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.64
74034200|NCT05896761|147621272|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.966|1.17||||||||1.17|0.966|
74034201|NCT05896761|147621272|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.07|1.29||||||||1.29|1.07|
74034202|NCT05896761|147621273|OTHER||Ratio of geometric least square mean|1.35|||||TWO_SIDED|90.0|1.22|1.49||||||||1.49|1.22|
74034203|NCT05896761|147621273|OTHER||Ratio of geometric least square mean|1.1|||||TWO_SIDED|90.0|0.975|1.24||||||||1.24|0.975|
74034204|NCT05896761|147621274|OTHER||Ratio of geometric least square mean|1.26|||||TWO_SIDED|90.0|1.12|1.4||||||||1.40|1.12|
74034205|NCT05896761|147621274|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.09|1.28||||||||1.28|1.09|
74034206|NCT05896761|147621275|OTHER||Ratio of geometric least square mean|1.21|||||TWO_SIDED|90.0|1.13|1.3||||||||1.30|1.13|
74034207|NCT05896761|147621275|OTHER||Ratio of geometric least square mean|1.09|||||TWO_SIDED|90.0|1.0|1.2||||||||1.20|1.00|
74034208|NCT05896761|147621276|OTHER||Ratio of geometric least square mean|1.15|||||TWO_SIDED|90.0|1.07|1.23||||||||1.23|1.07|
74034209|NCT05896761|147621276|OTHER||Ratio of geometric least square mean|1.29|||||TWO_SIDED|90.0|1.2|1.38||||||||1.38|1.20|
74034210|NCT05896761|147621277|OTHER||Ratio of geometric least square mean|1.16|||||TWO_SIDED|90.0|1.08|1.25||||||||1.25|1.08|
74034211|NCT05896761|147621277|OTHER||Ratio of geometric least square mean|0.983|||||TWO_SIDED|90.0|0.89|1.09||||||||1.09|0.890|
74034212|NCT05896761|147621278|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.991|1.13||||||||1.13|0.991|
74034213|NCT05896761|147621278|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.974|1.12||||||||1.12|0.974|
74034214|NCT05896761|147621279|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.11|1.25||||||||1.25|1.11|
74034215|NCT05896761|147621279|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.989|1.14||||||||1.14|0.989|
73956357|NCT01549314|147448495|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.78
73956358|NCT01549314|147448496|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.86
73956359|NCT01549314|147448496|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.99
73956360|NCT00930813|147448544|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||The study required 100 subjects to provide 80% power to detect a clinically meaningful difference in late lumen loss of 15% of reference vessel diameter between treatment groups on the basis of a 2-sample Student t test with 2-sided alpha 0.05.||||0.016
73956361|NCT01101165|147448565|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|96.6|||||TWO_SIDED|90.0|92.8|100.56|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||100.56|92.80|
73956362|NCT01101165|147448566|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.8|||||TWO_SIDED|90.0|92.42|97.24|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.24|92.42|
73956363|NCT01101165|147448567|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.5|||||TWO_SIDED|90.0|92.93|98.18|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||98.18|92.93|
73956364|NCT03404843|147448582|OTHER|||||||0.97|||||||ANOVA|||Within group comparison of treatment||||0.97
73956365|NCT03404843|147448582|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
73956366|NCT03404843|147448583|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
73956367|NCT03404843|147448583|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
73956368|NCT03404843|147448584|OTHER|||||||0.28|||||||ANOVA|||Within group comparison of treatment||||0.28
73956369|NCT03404843|147448584|OTHER|||||||0.37|||||||ANOVA|||Within group comparison of treatment||||0.37
73956370|NCT03404843|147448585|OTHER|||||||0.89|||||||ANOVA|||Within group comparison of treatment||||0.89
73956371|NCT03404843|147448585|OTHER|||||||0.3|||||||ANOVA|||Within group comparison of treatment||||0.30
73956372|NCT03404843|147448586|OTHER|||||||0.08|||||||ANOVA|||Within group comparison of treatment||||0.08
73956373|NCT03404843|147448586|OTHER|||||||0.05|||||||ANOVA|||Within group comparison of treatment||||0.05
73956374|NCT00567164|147448588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.85|STANDARD_DEVIATION|30.356||0.0001||95.0|-16.3|-7.394|||t-test, 2 sided|||||-7.394|-16.3|0.0001
73956375|NCT01859312|147448658|OTHER|||||||0.021|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.021
73956376|NCT01859312|147448660|OTHER|||||||0.027|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.027
73956377|NCT01859312|147448662|OTHER|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.008
73956378|NCT01859312|147448664|OTHER|||||||0.012|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.012
73956379|NCT01859312|147448666|OTHER|||||||0.157|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.157
73956380|NCT01859312|147448668|OTHER|||||||0.015|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.015
73956381|NCT01859312|147448670|OTHER|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.009
73956382|NCT01859312|147448672|OTHER|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.008
73956383|NCT01859312|147448674|OTHER|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.009
73956384|NCT01859312|147448676|OTHER|||||||0.043|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.043
73956385|NCT01859312|147448678|OTHER|||||||0.024|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.024
73956386|NCT01859312|147448680|OTHER|||||||0.031|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.031
73985196|NCT05135156|147516021|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.02|TWO_SIDED|95.0|3.0|25.0|||Regression, Linear||Difference = intervention - control|||25|3|0.02
73956387|NCT01859312|147448682|OTHER|||||||0.005|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.005
73956388|NCT01859312|147448684|OTHER|||||||0.004|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.004
73956389|NCT01859312|147448686|OTHER|||||||0.524|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.524
73956390|NCT01859312|147448688|OTHER|||||||0.007|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|Comparison of hormone levels on conventional glucocorticoid therapy at baseline and following 6 months of CSHI.|||0.007
73956391|NCT01859312|147448690|OTHER|||||||0.084|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.084
73956392|NCT01859312|147448692|OTHER|||||||0.057|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.057
73956393|NCT01859312|147448694|OTHER|||||||0.103|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.103
73956394|NCT01859312|147448696|OTHER|||||||0.07|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.070
73874921|NCT01521507|147291543|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|z-statistic|p-value was based on z-statistic of the sum of weighted average of difference in scores between groups at each site divided by the sum of the weights.||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt \> µc, where µt and µc are the mean changes in total meibomian gland scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Primary Outcome, the minimum sample size was 24 subjects per group with a power of 90% and a one-sided alpha of 0.025.||||<0.0001
73874922|NCT01521507|147291543|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.||||0.0020
73874923|NCT01521507|147291544|SUPERIORITY_OR_OTHER|||||||0.9098|TWO_SIDED||||||Mixed Models Analysis|Stage 2 Primary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.||The null and alternative hypotheses for the Stage 2 Primary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total meibomian gland score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.||||0.9098
73874924|NCT01521507|147291545|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED|||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|t-test, 2 sided|||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt \> µc, where µt and µc are the mean changes in total OSDI scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Secondary Outcome, the minimum sample size was 84 per group with a power of 80% and a one-sided alpha of 0.025.||||0.0068
73874925|NCT01521507|147291545|SUPERIORITY_OR_OTHER|||||||0.0419|TWO_SIDED||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.||||0.0419
73874926|NCT01521507|147291546|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED|||||Stage 2 Secondary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.|Mixed Models Analysis|||The null and alternative hypotheses for the Stage 2 Secondary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total OSDI score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.||||0.0237
73874927|NCT02501590|147291547|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73985197|NCT05135156|147516022|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.15|TWO_SIDED|95.0|-1.0|6.6|||Regression, Linear||Difference = intervention - control|||6.6|-1.0|0.15
73985198|NCT05135156|147516023|SUPERIORITY||Mean Difference (Net)|-1.2||||0.81|TWO_SIDED|95.0|-10.9|8.5|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||8.5|-10.9|0.81
73985199|NCT05135156|147516024|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.15|TWO_SIDED|95.0|-0.1|0.8|||Regression, Linear||Difference = intervention - control|||0.8|-0.1|0.15
73874928|NCT01290614|147291548|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
73874929|NCT01290614|147291549|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73874930|NCT01825187|147291576|SUPERIORITY|||||||0.523|||||||t-test, 1 sided|||||||0.523
73874931|NCT01825187|147291577|SUPERIORITY|||||||0.371|||||||t-test, 1 sided|||Nasa Mental Demand||||0.371
73874932|NCT01825187|147291577|SUPERIORITY|||||||0.122|||||||t-test, 1 sided|||NASA Physical Demand||||0.122
73874933|NCT01825187|147291577|SUPERIORITY|||||||0.325|||||||t-test, 1 sided|||NASA Temporal Demand||||0.325
73874934|NCT01825187|147291577|SUPERIORITY|||||||0.0451|||||||t-test, 1 sided|||NASA Peformance||||0.0451
73874935|NCT01363700|147291582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.52|-1.11|||t-test, 2 sided|||||-1.11|-1.52|<0.001
73874936|NCT01363700|147291583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.71|-0.92|||t-test, 2 sided|||||-0.92|-1.71|<0.001
73874937|NCT01363700|147291584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in Mean Ocular itching score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.21|0.08||||||||0.08|-0.21|
73874938|NCT01363700|147291585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in Mean Ocular hyperemia score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.81|0.22||||||||0.22|-0.81|
73874939|NCT02230566|147291586|SUPERIORITY||LS Mean|-64.82|||<|0.0001|TWO_SIDED|95.0|-69.66|-59.98||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE|||||-59.98|-69.66|< 0.0001
73985200|NCT05135156|147516025|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.54|TWO_SIDED|95.0|-2.0|3.7|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||3.7|-2.0|0.54
73985201|NCT05135156|147516027|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.82|TWO_SIDED|95.0|-2.1|2.7|||Regression, Linear||Difference = intervention - control|||2.7|-2.1|0.82
73985202|NCT05135156|147516029|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.44|TWO_SIDED|95.0|-15.0|7.0|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||7|-15|0.44
73985203|NCT05135156|147516030|SUPERIORITY||Mean Difference (Net)|1.3||||0.31|TWO_SIDED|95.0|-1.3|3.9|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||3.9|-1.3|0.31
74034216|NCT05896761|147621280|OTHER||Ratio of geometric least square mean|1.08|||||TWO_SIDED|90.0|1.03|1.12||||||||1.12|1.03|
73985204|NCT05135156|147516031|SUPERIORITY||Mean Difference (Net)|5.0||||0.42|TWO_SIDED|95.0|-7.4|17.4|||Regression, Linear||Difference = intervention - control||Estimation parameter is regression parameter comparing intervention to control|17.4|-7.4|0.42
73985205|NCT05135156|147516032|OTHER|Pearson's chi-squared test of independence||||||0.39||||||p=0.39 at baseline, 0.39 at 2 weeks and 0.23 at 4 weeks|Chi-squared|||||||0.39
73985206|NCT05135156|147516033|SUPERIORITY||Mean Difference (Net)|0.05||||0.91|TWO_SIDED|95.0|-0.84|0.94|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) from baseline to 2-week study visit||0.94|-0.84|0.91
73985207|NCT05135156|147516033|SUPERIORITY||Mean Difference (Net)|0.04||||0.53|TWO_SIDED|95.0|-0.08|0.16|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in Likert preparedness to discuss transplant from baseline to 2-week study visit||0.16|-0.08|0.53
73985208|NCT05135156|147516033|SUPERIORITY||Mean Difference (Net)|-4.3||||0.04|TWO_SIDED|95.0|-8.4|-0.3|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in Decisional Conflict Scale from baseline to 2-week study visit||-0.3|-8.4|0.04
73985209|NCT05135156|147516033|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.74|TWO_SIDED|95.0|-3.6|5.0||Outcome = mean PrepDM Scale at 2-weeks|Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|||5.0|-3.6|0.74
73985210|NCT00694564|147516059|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was calculated as this was a pilot study to determine such parameters.||||||0.004||95.0|||||MANOVA|||||||0.004
73985211|NCT02720081|147516066|SUPERIORITY||Difference in least squares means|-4.775||||0.352|TWO_SIDED|95.0|-14.92|5.37|||ANOVA|Terms for treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.||||5.370|-14.92|0.352
73985212|NCT02720081|147516067|OTHER||Difference in percentages|-0.4|||||TWO_SIDED|95.0|-15.0|14.3|||||Based on Miettinen \& Nurminen|||14.3|-15.0|
73985213|NCT02720081|147516068|OTHER||Difference in percentages|-4.3|||||TWO_SIDED|95.0|-12.1|1.0|||||Based on Miettinen \& Nurminen|||1.0|-12.1|
73985214|NCT02720081|147516090|SUPERIORITY||Difference in least squares means|0.107||||0.023|TWO_SIDED|95.0|0.015|0.199|||Constrained longitudinal data analysis|Terms for treatment, time, interaction of time by treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.||||0.199|0.015|0.023
73985215|NCT03209050|147516091|OTHER|||||||0.5|||||||Clopper-Pearson 95% CI|||||||0.5
73985216|NCT02005029|147516093|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
73985217|NCT02005029|147516094|SUPERIORITY_OR_OTHER||Erythromycin:Placebo AUC ratio|1.07|STANDARD_DEVIATION|0.43|||TWO_SIDED|||||||||||||
73985218|NCT02005029|147516095|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
73985219|NCT02005029|147516096|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
73985220|NCT02005029|147516097|SUPERIORITY_OR_OTHER|||||||0.4405|||||||t-test, 2 sided|||||||0.4405
73985221|NCT02005029|147516098|SUPERIORITY_OR_OTHER|||||||0.6011|||||||t-test, 2 sided|||||||0.6011
73985222|NCT02005029|147516099|SUPERIORITY_OR_OTHER|||||||0.8923|||||||t-test, 2 sided|||||||0.8923
73985223|NCT02005029|147516100|SUPERIORITY_OR_OTHER|||||||0.832|||||||t-test, 2 sided|||||||0.832
73985224|NCT02005029|147516101|SUPERIORITY_OR_OTHER|||||||0.1546|||||||t-test, 2 sided|||||||0.1546
73985225|NCT02005029|147516102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75|STANDARD_DEVIATION|5.0||0.0314|TWO_SIDED||||||t-test, 2 sided||"Mean difference in on score versus off score from the MDS UPDRS Part 3 on day of erythromycin minus the mean difference in 'on score versus off score on day of placebo."|||||0.0314
73985226|NCT02005029|147516103|SUPERIORITY_OR_OTHER||Erythromycin:Placebo Cmax ratio|0.83|STANDARD_DEVIATION|0.24|||TWO_SIDED|||||||||||||
73985227|NCT01855997|147516113|SUPERIORITY_OR_OTHER|||||||5.59e-06|TWO_SIDED||||||t-test, 2 sided|||rs1876154||||0.00000559
73985228|NCT01855997|147516113|SUPERIORITY_OR_OTHER|||||||7.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs2812338||||0.00000766
73985229|NCT01855997|147516113|SUPERIORITY_OR_OTHER|||||||9.82e-06|TWO_SIDED||||||t-test, 2 sided|||rs10824875||||0.00000982
73985230|NCT01855997|147516113|SUPERIORITY_OR_OTHER|||||||1.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000127
73985231|NCT01855997|147516113|SUPERIORITY_OR_OTHER|||||||3.96e-06|TWO_SIDED||||||t-test, 2 sided|||rs10851257||||0.00000396
73985232|NCT01855997|147516113|SUPERIORITY_OR_OTHER|||||||6.48e-06|TWO_SIDED||||||t-test, 2 sided|||rs6492344||||0.00000648
73985233|NCT01855997|147516113|SUPERIORITY_OR_OTHER|||||||2.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs12584550||||0.00000221
73985234|NCT01855997|147516113|SUPERIORITY_OR_OTHER|||||||9.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs9555773||||0.00000902
73985235|NCT01855997|147516113|SUPERIORITY_OR_OTHER|||||||7.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000077
73985236|NCT01855997|147516113|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000048
73985237|NCT01855997|147516113|SUPERIORITY_OR_OTHER|||||||3.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000037
73985238|NCT01855997|147516114|SUPERIORITY_OR_OTHER|||||||9.87e-06|TWO_SIDED||||||t-test, 2 sided|||rs1876154||||0.00000987
73985239|NCT01855997|147516114|SUPERIORITY_OR_OTHER|||||||6.05e-06|TWO_SIDED||||||t-test, 2 sided|||rs7753766||||0.00000605
73985240|NCT01855997|147516114|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs604241||||0.00000946
73985241|NCT01855997|147516114|SUPERIORITY_OR_OTHER|||||||7.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000077
73985242|NCT01855997|147516114|SUPERIORITY_OR_OTHER|||||||1.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000197
73985243|NCT01855997|147516115|SUPERIORITY_OR_OTHER|||||||6.77e-06|TWO_SIDED||||||t-test, 2 sided|||rs12210761||||0.00000677
73985244|NCT01855997|147516115|SUPERIORITY_OR_OTHER|||||||7.98e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000798
73985245|NCT01855997|147516115|SUPERIORITY_OR_OTHER|||||||5.12e-06|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000512
73985246|NCT01855997|147516115|SUPERIORITY_OR_OTHER|||||||3.45e-06|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000345
73985247|NCT01855997|147516115|SUPERIORITY_OR_OTHER|||||||3.72e-06|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000372
73985248|NCT01855997|147516116|SUPERIORITY_OR_OTHER|||||||4.59e-06|TWO_SIDED||||||t-test, 2 sided|||rs12210761||||0.00000459
73985249|NCT01855997|147516116|SUPERIORITY_OR_OTHER|||||||9.25e-06|TWO_SIDED||||||t-test, 2 sided|||rs1411283||||0.00000925
73874940|NCT02230566|147291587|SUPERIORITY|||||||0.0527|||||||t-test|"P value from t-test of no change (0 change) from baseline"||||||0.0527
73985250|NCT01855997|147516116|SUPERIORITY_OR_OTHER|||||||7.72e-06|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000772
73985251|NCT01855997|147516117|SUPERIORITY_OR_OTHER|||||||4.7e-06|TWO_SIDED||||||t-test, 2 sided|||rs11163805||||0.00000470
73985252|NCT01855997|147516117|SUPERIORITY_OR_OTHER|||||||6.74e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000674
73985253|NCT01855997|147516117|SUPERIORITY_OR_OTHER|||||||9.52e-06|TWO_SIDED||||||t-test, 2 sided|||rs11139349||||0.00000952
73985254|NCT01855997|147516117|SUPERIORITY_OR_OTHER|||||||6.08e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000608
73985255|NCT01855997|147516117|SUPERIORITY_OR_OTHER|||||||4.04e-06|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000404
73985256|NCT01855997|147516117|SUPERIORITY_OR_OTHER|||||||4.07e-06|TWO_SIDED||||||t-test, 2 sided|||rs11868362||||0.00000407
73985257|NCT01855997|147516118|SUPERIORITY_OR_OTHER|||||||6.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs1384010||||0.00000666
73985258|NCT01855997|147516118|SUPERIORITY_OR_OTHER|||||||8.44e-06|TWO_SIDED||||||t-test, 2 sided|||rs1351518||||0.00000844
73985259|NCT01855997|147516118|SUPERIORITY_OR_OTHER|||||||7.94e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000794
73985260|NCT01855997|147516118|SUPERIORITY_OR_OTHER|||||||3.1e-06|TWO_SIDED||||||t-test, 2 sided|||rs11868362||||0.00000310
73985261|NCT01855997|147516119|SUPERIORITY_OR_OTHER|||||||2.07e-06|TWO_SIDED||||||t-test, 2 sided|||rs11139349||||0.00000207
74089698|NCT03545191|147732301|OTHER||LS mean difference to placebo|-22.78|||<|0.0001|TWO_SIDED|95.0|-27.996|-17.567||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 50 mg vs placebo).||-17.567|-27.996|<0.0001
73985262|NCT01855997|147516119|SUPERIORITY_OR_OTHER|||||||8.99e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000899
73985263|NCT01855997|147516120|SUPERIORITY_OR_OTHER|||||||5.73e-06|TWO_SIDED||||||t-test, 2 sided|||rs1384010||||0.00000573
73985264|NCT01855997|147516120|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs1351518||||0.00000946
73985265|NCT01855997|147516120|SUPERIORITY_OR_OTHER|||||||7.31e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000731
73985266|NCT01855997|147516120|SUPERIORITY_OR_OTHER|||||||9.45e-06|TWO_SIDED||||||t-test, 2 sided|||rs646097||||0.00000945
73985267|NCT01855997|147516121|SUPERIORITY_OR_OTHER|||||||1.6e-07|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000016
73985268|NCT01855997|147516122|SUPERIORITY_OR_OTHER|||||||8.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000088
73985269|NCT01855997|147516123|SUPERIORITY_OR_OTHER|||||||8.79e-06|TWO_SIDED||||||t-test, 2 sided|||rs2464266||||0.00000879
73985270|NCT01855997|147516124|SUPERIORITY_OR_OTHER|||||||4.52e-06|TWO_SIDED||||||t-test, 2 sided|||rs9496139||||0.00000452
73985271|NCT01855997|147516124|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2014238||||0.00000497
73985272|NCT01855997|147516124|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2980231||||0.00000497
73985273|NCT01855997|147516125|SUPERIORITY_OR_OTHER|||||||7.48e-06|TWO_SIDED||||||t-test, 2 sided|||exm2237722||||0.00000748
73985274|NCT01855997|147516125|SUPERIORITY_OR_OTHER|||||||7.3e-07|TWO_SIDED||||||t-test, 2 sided|||rs16924016||||0.00000073
73985275|NCT01855997|147516125|SUPERIORITY_OR_OTHER|||||||2.89e-06|TWO_SIDED||||||t-test, 2 sided|||rs2899723||||0.00000289
73985276|NCT01855997|147516125|SUPERIORITY_OR_OTHER|||||||9.12e-06|TWO_SIDED||||||t-test, 2 sided|||rs8027115||||0.00000912
73985277|NCT01855997|147516125|SUPERIORITY_OR_OTHER|||||||4.94e-06|TWO_SIDED||||||t-test, 2 sided|||exm2267780||||0.00000494
73985278|NCT01855997|147516126|SUPERIORITY_OR_OTHER|||||||6.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs9973954||||0.00000627
73985279|NCT01855997|147516126|SUPERIORITY_OR_OTHER|||||||6.96e-06|TWO_SIDED||||||t-test, 2 sided|||exm2237722||||0.00000696
73985280|NCT01855997|147516126|SUPERIORITY_OR_OTHER|||||||4.26e-06|TWO_SIDED||||||t-test, 2 sided|||rs1040084||||0.00000426
73985281|NCT01855997|147516126|SUPERIORITY_OR_OTHER|||||||4.35e-06|TWO_SIDED||||||t-test, 2 sided|||rs1913484||||0.00000435
73985282|NCT01855997|147516126|SUPERIORITY_OR_OTHER|||||||2.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs16924016||||0.00000221
73985283|NCT01855997|147516126|SUPERIORITY_OR_OTHER|||||||5.23e-06|TWO_SIDED||||||t-test, 2 sided|||exm1010813||||0.00000523
73985284|NCT01855997|147516126|SUPERIORITY_OR_OTHER|||||||7.57e-06|TWO_SIDED||||||t-test, 2 sided|||rs6576456||||0.00000757
73985285|NCT01855997|147516127|SUPERIORITY_OR_OTHER|||||||1.53e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000153
73985286|NCT01855997|147516127|SUPERIORITY_OR_OTHER|||||||7.08e-06|TWO_SIDED||||||t-test, 2 sided|||rs10475403||||0.00000708
73985287|NCT01855997|147516127|SUPERIORITY_OR_OTHER|||||||7.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs715243||||0.00000727
73985288|NCT01855997|147516128|SUPERIORITY_OR_OTHER|||||||3.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000397
73985289|NCT01855997|147516129|SUPERIORITY_OR_OTHER|||||||6.86e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000686
73985290|NCT01855997|147516129|SUPERIORITY_OR_OTHER|||||||5.96e-06|TWO_SIDED||||||t-test, 2 sided|||rs2189452||||0.00000596
73985291|NCT01855997|147516129|SUPERIORITY_OR_OTHER|||||||4.89e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000489
73985292|NCT01855997|147516130|SUPERIORITY_OR_OTHER|||||||8.34e-06|TWO_SIDED||||||t-test, 2 sided|||rs2189452||||0.00000834
73985293|NCT01855997|147516130|SUPERIORITY_OR_OTHER|||||||4.87e-06|TWO_SIDED||||||t-test, 2 sided|||rs7968170||||0.00000487
73985294|NCT01855997|147516130|SUPERIORITY_OR_OTHER|||||||9.18e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000918
73985295|NCT01855997|147516131|SUPERIORITY_OR_OTHER|||||||1.37e-06|TWO_SIDED||||||t-test, 2 sided|||rs9287655||||0.00000137
73985296|NCT01855997|147516131|SUPERIORITY_OR_OTHER|||||||3.39e-06|TWO_SIDED||||||t-test, 2 sided|||rs2803073||||0.00000339
73985297|NCT01855997|147516131|SUPERIORITY_OR_OTHER|||||||9.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs1937590||||0.00000927
73985298|NCT01855997|147516131|SUPERIORITY_OR_OTHER|||||||1.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs2945861||||0.00000166
73985299|NCT01855997|147516131|SUPERIORITY_OR_OTHER|||||||4.55e-06|TWO_SIDED||||||t-test, 2 sided|||rs1997894||||0.00000455
73985300|NCT01855997|147516131|SUPERIORITY_OR_OTHER|||||||5.68e-06|TWO_SIDED||||||t-test, 2 sided|||rs1495471||||0.00000568
73874941|NCT02230566|147291588|SUPERIORITY||LS Mean|20.8||||0.2137|TWO_SIDED|95.0|-12.0|53.7||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE|||||53.7|-12.0|0.2137
73985301|NCT01855997|147516131|SUPERIORITY_OR_OTHER|||||||1.25e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000125
73985302|NCT01855997|147516131|SUPERIORITY_OR_OTHER|||||||9.82e-06|TWO_SIDED||||||t-test, 2 sided|||rs1152537||||0.00000982
73985303|NCT01855997|147516132|SUPERIORITY_OR_OTHER|||||||8.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs10236906||||0.00000846
73985304|NCT01855997|147516132|SUPERIORITY_OR_OTHER|||||||5.62e-06|TWO_SIDED||||||t-test, 2 sided|||rs2945861||||0.00000562
73985305|NCT01855997|147516132|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs7042473||||0.00000497
73985306|NCT01855997|147516132|SUPERIORITY_OR_OTHER|||||||9.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2077415||||0.00000997
73985307|NCT01855997|147516132|SUPERIORITY_OR_OTHER|||||||8.64e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000864
73985308|NCT01855997|147516133|SUPERIORITY_OR_OTHER|||||||3.68e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000368
73985309|NCT01855997|147516133|SUPERIORITY_OR_OTHER|||||||5.77e-06|TWO_SIDED||||||t-test, 2 sided|||rs715243||||0.00000577
73985310|NCT01855997|147516134|SUPERIORITY_OR_OTHER|||||||9.5e-06|TWO_SIDED||||||t-test, 2 sided|||rs2302503||||0.00000950
73985311|NCT01855997|147516134|SUPERIORITY_OR_OTHER|||||||7.41e-06|TWO_SIDED||||||t-test, 2 sided|||rs6015181||||0.00000741
73985312|NCT01855997|147516135|SUPERIORITY_OR_OTHER|||||||8.05e-06|TWO_SIDED||||||t-test, 2 sided|||rs1550116||||0.00000805
73874942|NCT02230566|147291591|SUPERIORITY||LS Mean|-6.5||||0.1778|TWO_SIDED|95.0|-16.1|3.0|||GEE|||Shoulder Flexion - Left||3.0|-16.1|0.1778
73874943|NCT02230566|147291591|SUPERIORITY||LS Mean|-1.5||||0.7632|TWO_SIDED|95.0|-10.9|8.0|||GEE|||Shoulder Extension - Left||8.0|-10.9|0.7632
73985313|NCT01855997|147516135|SUPERIORITY_OR_OTHER|||||||7.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs1550115||||0.00000702
73985314|NCT01855997|147516135|SUPERIORITY_OR_OTHER|||||||7.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs2082881||||0.00000702
73985315|NCT01855997|147516135|SUPERIORITY_OR_OTHER|||||||7.43e-06|TWO_SIDED||||||t-test, 2 sided|||exm2265462||||0.00000743
73985316|NCT01855997|147516135|SUPERIORITY_OR_OTHER|||||||7.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000078
73985317|NCT01855997|147516135|SUPERIORITY_OR_OTHER|||||||8.94e-06|TWO_SIDED||||||t-test, 2 sided|||rs1403069||||0.00000894
73985318|NCT01855997|147516135|SUPERIORITY_OR_OTHER|||||||5.71e-06|TWO_SIDED||||||t-test, 2 sided|||rs9691873||||0.00000571
73985319|NCT01855997|147516135|SUPERIORITY_OR_OTHER|||||||7.29e-06|TWO_SIDED||||||t-test, 2 sided|||rs8012912||||0.00000729
73985320|NCT01855997|147516135|SUPERIORITY_OR_OTHER|||||||8.28e-06|TWO_SIDED||||||t-test, 2 sided|||rs11158827||||0.00000828
73985321|NCT01855997|147516135|SUPERIORITY_OR_OTHER|||||||8.85e-06|TWO_SIDED||||||t-test, 2 sided|||rs11870323||||0.00000885
73985322|NCT01855997|147516135|SUPERIORITY_OR_OTHER|||||||7.17e-06|TWO_SIDED||||||t-test, 2 sided|||rs4821558||||0.00000717
73985323|NCT01855997|147516136|SUPERIORITY_OR_OTHER|||||||6.29e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000629
73985324|NCT01855997|147516136|SUPERIORITY_OR_OTHER|||||||5.79e-06|TWO_SIDED||||||t-test, 2 sided|||rs1692421||||0.00000579
73985325|NCT01855997|147516136|SUPERIORITY_OR_OTHER|||||||5.53e-06|TWO_SIDED||||||t-test, 2 sided|||rs1692423||||0.00000553
73985326|NCT01855997|147516136|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs9691873||||0.00000946
73985327|NCT01855997|147516136|SUPERIORITY_OR_OTHER|||||||4.5e-06|TWO_SIDED||||||t-test, 2 sided|||rs7968170||||0.00000450
73985328|NCT01855997|147516137|SUPERIORITY_OR_OTHER|||||||1.18e-06|TWO_SIDED||||||t-test, 2 sided|||rs9287655||||0.00000118
73985329|NCT01855997|147516137|SUPERIORITY_OR_OTHER|||||||5.31e-06|TWO_SIDED||||||t-test, 2 sided|||rs216312||||0.00000531
73985330|NCT01855997|147516138|SUPERIORITY_OR_OTHER|||||||5.93e-06|TWO_SIDED||||||t-test, 2 sided|||rs993147||||0.00000593
73985331|NCT01855997|147516138|SUPERIORITY_OR_OTHER|||||||9.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs10978436||||0.00000997
73985332|NCT01855997|147516138|SUPERIORITY_OR_OTHER|||||||5.81e-06|TWO_SIDED||||||t-test, 2 sided|||rs2370220||||0.00000581
73985333|NCT01855997|147516138|SUPERIORITY_OR_OTHER|||||||8.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs2279519||||0.00000802
73985334|NCT01855997|147516139|SUPERIORITY_OR_OTHER|||||||5.58e-06|TWO_SIDED||||||t-test, 2 sided|||rs12992677||||0.00000558
73985335|NCT01855997|147516140|SUPERIORITY_OR_OTHER|||||||9.9e-06|TWO_SIDED||||||t-test, 2 sided|||rs12992677||||0.00000990
73985336|NCT01855997|147516141|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs7549785||||0.00000048
73985337|NCT01855997|147516142|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs7549785||||0.00000048
73985338|NCT01855997|147516143|SUPERIORITY_OR_OTHER|||||||7.38e-06|TWO_SIDED||||||t-test, 2 sided|||rs10814834||||0.00000738
73985339|NCT01855997|147516143|SUPERIORITY_OR_OTHER|||||||4.51e-06|TWO_SIDED||||||t-test, 2 sided|||rs10491723||||0.00000451
73985340|NCT01855997|147516143|SUPERIORITY_OR_OTHER|||||||8.78e-06|TWO_SIDED||||||t-test, 2 sided|||rs6592052||||0.00000878
73985341|NCT01855997|147516143|SUPERIORITY_OR_OTHER|||||||5.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs16943470||||0.00000521
73985342|NCT01855997|147516144|SUPERIORITY_OR_OTHER|||||||7.2e-06|TWO_SIDED||||||t-test, 2 sided|||rs6592052||||0.00000720
73985343|NCT03866434|147516166|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LSmeans|64.225|||||TWO_SIDED|90.0|53.212|77.516|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the least squares (LS) mean difference in the log-transformed parameters back transformed to the original scale) and their 90 percent (%) confidence intervals (CI) were calculated.||77.516|53.212|
74034217|NCT05896761|147621280|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.997|1.08||||||||1.08|0.997|
74034218|NCT05896761|147621281|OTHER||Ratio of geometric least square mean|1.13|||||TWO_SIDED|90.0|1.08|1.19||||||||1.19|1.08|
74034219|NCT05896761|147621281|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.97|1.11||||||||1.11|0.97|
74034220|NCT05896761|147621282|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|1.02|1.11||||||||1.11|1.02|
73985344|NCT03866434|147516167|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|%ratio of Geometric LeastSquare(LS)means|82.203|||||TWO_SIDED|90.0|71.501|94.507|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||94.507|71.501|
73985345|NCT03866434|147516168|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.705|||||TWO_SIDED|90.0|64.555|84.152|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||84.152|64.555|
73985346|NCT03866434|147516169|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|85.527|||||TWO_SIDED|90.0|78.163|93.584|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||93.584|78.163|
73985347|NCT03866434|147516170|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.007|||||TWO_SIDED|90.0|62.528|85.243|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||85.243|62.528|
73985348|NCT03866434|147516171|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|86.504|||||TWO_SIDED|90.0|78.462|95.371|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||95.371|78.462|
73985349|NCT00179478|147516192|SUPERIORITY|||||||0.001||||||Based on adjusted Hazard Ratio (HR)|Regression, Cox|HR adjusted for age, onset event type, baseline brain MRI T2 lesion and number and baseline number of gad enhancing lesions||||||0.001
73985350|NCT00179478|147516193|SUPERIORITY|||||||0.02||||||a priori threshold for statistical significance was a p value less than 0.01|Wilcoxon (Mann-Whitney)|||||||0.02
73985351|NCT00179478|147516194|SUPERIORITY|||||||0.61||||||a priori threshold for statistical significance was a p value \< 0.01|Fisher Exact|||||||0.61
73985352|NCT00179478|147516195|SUPERIORITY|||||||0.5||||||a priori threshold for statistical significant was a p value less than 0.01|Fisher Exact|||||||0.50
73985353|NCT04474691|147516196|SUPERIORITY||Mean Difference (Final Values)|21.1||||0.67|TWO_SIDED||||||t-test, 1 sided|df = 7|Traditional treatment condition - visual-acoustic biofeedback treatment condition. Because more accurate productions have lower acoustic values, a positive difference would indicate an advantage for biofeedback.|||||.67
74034221|NCT05896761|147621282|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|1.01|1.11||||||||1.11|1.01|
73874944|NCT02230566|147291591|SUPERIORITY||LS Mean|-1.8||||0.6034|TWO_SIDED|95.0|-8.8|5.1|||GEE|||Shoulder Flexion - Right||5.1|-8.8|0.6034
73874945|NCT02230566|147291591|SUPERIORITY||LS Mean|-3.4||||0.3332|TWO_SIDED|95.0|-10.2|3.4|||GEE|||Shoulder Extension - Right||3.4|-10.2|0.3332
73874946|NCT02230566|147291591|SUPERIORITY||LS Mean|-9.4||||0.0415|TWO_SIDED|95.0|-18.4|-0.4|||GEE|||Tighter Shoulder Flexion||-0.4|-18.4|0.0415
73874947|NCT02230566|147291591|SUPERIORITY||LS Mean|-6.7||||0.0563|TWO_SIDED|95.0|-13.6|0.2|||GEE|||Tighter Shoulder Extension||0.2|-13.6|0.0563
73874948|NCT02230566|147291592|SUPERIORITY||LS Mean|1.0||||0.114|TWO_SIDED|95.0|-0.2|2.2|||GEE|||for the left eye||2.2|-0.2|0.1140
73874949|NCT02230566|147291592|SUPERIORITY||LS Mean|0.9||||0.0906|TWO_SIDED|95.0|-0.1|1.8|||GEE|||for the right eye||1.8|-0.1|0.0906
73874950|NCT02230566|147291593|SUPERIORITY||LS Mean|0.8||||0.0883|TWO_SIDED|95.0|-0.1|1.7|||GEE|||Scale-BALANCE||1.7|-0.1|0.0883
74034222|NCT01842620|147621318|EQUIVALENCE|Geometric means ratio for AUC (0-t) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-36)*100|100.0|||||TWO_SIDED|90.0|92.62|107.98|||||Ratio of AUC0-36= (AUC0-36 of Test)/ AUC 0-36 Reference)|Overall period||107.98|92.62|
74034223|NCT01842620|147621319|EQUIVALENCE|Geometric means ratio for AUC(0-inf) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-inf)*100|99.02|||||TWO_SIDED|90.0|92.26|106.27|||||Ratio of AUC0-inf= (AUC0-inf of Test) / (AUC 0-inf of Reference)|For overall period||106.27|92.26|
73874951|NCT02230566|147291593|SUPERIORITY||LS Mean|-0.2||||0.3528|TWO_SIDED|95.0|-0.7|0.2|||GEE|||Scale: FINE MOTOR PRECISION||0.2|-0.7|0.3528
73874952|NCT02230566|147291593|SUPERIORITY||LS Mean|0.2||||0.4094|TWO_SIDED|95.0|-0.2|0.6|||GEE|||Scale-MANUAL DEXTERITY||0.6|-0.2|0.4094
73874953|NCT02230566|147291593|SUPERIORITY||LS Mean|0.2||||0.102|TWO_SIDED|95.0|0.0|0.4|||GEE|||Scale-RUNNING SPEED AND AGILITY||0.4|0.0|0.1020
73985354|NCT00139659|147516197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.08|0.011|||longitudinal data analysis model|Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.|Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.||0.011|-0.080|
73985355|NCT00139659|147516198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.065|0.015|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.015|-0.065|
73985356|NCT00139659|147516198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.073|0.006|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.006|-0.073|
73985357|NCT00139659|147516198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.063|0.016|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.016|-0.063|
73985358|NCT00139659|147516198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.075|0.004|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.004|-0.075|
73985359|NCT00139659|147516198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.067|0.012|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.012|-0.067|
73985360|NCT00139659|147516198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.073|0.008|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.008|-0.073|
73985361|NCT00139659|147516198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.059|0.023|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.023|-0.059|
73985362|NCT00139659|147516198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.052|0.031|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.031|-0.052|
74034224|NCT01842620|147621320|EQUIVALENCE|Geometric means ratio for Cmax of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of Cmax)*100|98.34|||||TWO_SIDED|90.0|88.54|109.22|||||Ratio of Cmax= (Cmax of Test) / (Cmax of Reference)|Overall period||109.22|88.54|
73874954|NCT02230566|147291594|SUPERIORITY||LS Mean|3.4||||0.1953|TWO_SIDED|95.0|-1.8|8.6|||GEE|||||8.6|-1.8|0.1953
73874955|NCT02230566|147291596|SUPERIORITY||LS Mean|-1.2||||0.2022|TWO_SIDED|95.0|-3.0|0.6|||GEE|||||0.6|-3.0|0.2022
73874956|NCT00113841|147291597|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
73874957|NCT01126723|147291626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||The a priori threshold for statistical significance was set to 0.05.|Fisher Exact|||||||0.15
73874958|NCT03901144|147291630|SUPERIORITY||Mean Difference (Final Values)|-9.026|||<|0.001|TWO_SIDED|95.0|-12.562|-5.489|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-5.489|-12.562|<0.001
73874959|NCT03901144|147291630|SUPERIORITY||Mean Difference (Final Values)|-4.194||||0.021|TWO_SIDED|95.0|-7.76|-0.629|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-0.629|-7.760|0.021
73874960|NCT03901144|147291630|SUPERIORITY||Mean Difference (Final Values)|-9.021|||<|0.001|TWO_SIDED|95.0|-12.602|-5.44|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-5.440|-12.602|<0.001
73874961|NCT03901144|147291631|SUPERIORITY||Mean Difference (Final Values)|-3.538|||<|0.001|TWO_SIDED|95.0|-5.114|-1.962|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-1.962|-5.114|<0.001
73874962|NCT03901144|147291631|SUPERIORITY||Mean Difference (Final Values)|-1.748||||0.031|TWO_SIDED|95.0|-3.332|-0.164|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-0.164|-3.332|0.031
73985363|NCT00139659|147516198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.068|0.017|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.017|-0.068|
74034225|NCT02915367|147621346|OTHER|Pearson chi-square||||||0.93|||||||Chi-squared|||||||0.93
74034226|NCT02915367|147621348|OTHER|Pearson chi-square||||||0.96|||||||Chi-squared|||||||0.96
73874963|NCT03901144|147291631|SUPERIORITY||Mean Difference (Final Values)|-4.744|||<|0.001|TWO_SIDED|95.0|-6.332|-3.156|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-3.156|-6.332|<0.001
73985364|NCT00139659|147516198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.117|-0.029|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.029|-0.117|
73985365|NCT00139659|147516198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.108|-0.015|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.015|-0.108|
73985366|NCT00139659|147516199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.327|STANDARD_ERROR_OF_MEAN|0.214||||90.0|-0.679|0.026|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.026|-0.679|
74034227|NCT00952289|147621358|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The primary endpoint analyzed with a 2-sided alpha of 0.05.||||<0.0001
74034228|NCT02932475|147621369|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.63|1.19|||||The odds ratio was calculated and adjusted for study site, timing of diabetes diagnosis, gestational age at randomization stratified at 18 weeks, and baseline maternal BMI.|The sample size gave adequate power over a range of expected primary outcome event rates, with type I error set at 0.044 (reduced from 0.05 for interim analysis), with reasonable power under a conservative scenario assuming that 20% of subjects immediately stopped taking study agent.||1.19|0.63|
74034229|NCT02932475|147621370|SUPERIORITY||Difference in proportions|0.2||||0.4|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||||||0.4
73985367|NCT00139659|147516199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.729|-0.027|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.027|-0.729|
73985368|NCT00139659|147516199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.696|0.004|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.004|-0.696|
73985369|NCT00139659|147516199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.496|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.847|-0.145|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.145|-0.847|
73985370|NCT00139659|147516199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.96|-0.26|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.260|-0.960|
74034230|NCT02932475|147621371|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided||comparison of mean (sd) between groups|||||0.4
74034231|NCT02932475|147621372|SUPERIORITY||Difference in proportions|0.0||||0.6|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05.|Chi-squared|||||||0.6
74034232|NCT02932475|147621373|SUPERIORITY||Difference in proportions|0.0||||0.08|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05.|Chi-squared|||||||0.08
74034233|NCT00364845|147621378|SUPERIORITY_OR_OTHER||Proportion achieving target|0.389||||||95.0|0.173|0.643||||||||0.643|0.173|
73874964|NCT03901144|147291632|SUPERIORITY||Mean Difference (Final Values)|-19.077||||0.002|TWO_SIDED|95.0|-31.325|-6.829|||ANCOVA|||Summary of Redness-Mexameter change from day 29 to day 31||-6.829|-31.325|0.002
74034234|NCT00364845|147621378|SUPERIORITY_OR_OTHER||Proportion achieving target|0.95||||||95.0|0.751|0.999||||||||0.999|0.751|
74034235|NCT04160468|147621381|SUPERIORITY||Risk Difference (RD)|-10.6||||0.392|TWO_SIDED|95.0|-33.6|12.4|||Fisher Exact|||||12.4|-33.6|0.392
74034236|NCT01187901|147621383|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74034237|NCT01187901|147621384|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74034238|NCT01187901|147621385|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74034239|NCT01187901|147621386|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73874965|NCT03901144|147291632|SUPERIORITY||Mean Difference (Final Values)|-4.493||||0.471|TWO_SIDED|95.0|-16.787|7.801|||ANCOVA|||||7.801|-16.787|0.471
73874966|NCT03901144|147291632|SUPERIORITY||Mean Difference (Final Values)|-27.035|||<|0.001|TWO_SIDED|95.0|-39.372|-14.698|||ANCOVA|||Summary of Redness - Mexameter change from day 29 to day 31||-14.698|-39.372|<0.001
74034240|NCT01187901|147621387|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74034241|NCT01187901|147621388|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74034242|NCT03453151|147621427|OTHER|||||||0.053|||||||Paired t-test|||||||0.053
74034243|NCT03453151|147621428|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
74034244|NCT03453151|147621429|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
74034245|NCT03453151|147621430|OTHER|||||||0.077|||||||Paired t-test|This analysis refers to the resting cardiac index.||||||0.077
74034246|NCT03453151|147621430|OTHER|||||||0.069|||||||Paired t-test|This analysis refers to the peak exercise cardiac index.||||||0.069
74034247|NCT03453151|147621432|OTHER|||||||0.25|||||||Paired t-test|This analysis refers to creatinine level.||||||0.250
74034248|NCT03453151|147621432|OTHER|||||||0.014|||||||Paired t-test|This analysis refers to BUN level.||||||0.014
73874967|NCT03901144|147291634|SUPERIORITY||Mean Difference (Net)|-0.354|||<|0.001|TWO_SIDED|95.0|-0.558|-0.15|||ANCOVA|||Summary of Visual Redness at day 31||-0.150|-0.558|<0.001
73874968|NCT03901144|147291634|SUPERIORITY||Mean Difference (Final Values)|-0.089||||0.392|TWO_SIDED|95.0|-0.292|0.115|||ANCOVA|||Summary of Visual Redness at day 31||0.115|-0.292|0.392
73874969|NCT03901144|147291634|SUPERIORITY||Mean Difference (Final Values)|-0.447|||<|0.001|TWO_SIDED|95.0|-0.652|-0.242|||ANCOVA|||Summary of Visual Redness at day 31||-0.242|-0.652|<0.001
73985371|NCT00139659|147516199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.219||||90.0|-0.721|0.001|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.001|-0.721|
73985372|NCT00139659|147516199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.221||||90.0|-0.655|0.073|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.073|-0.655|
73985373|NCT00139659|147516199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.224||||90.0|-0.788|-0.052|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.052|-0.788|
73985374|NCT00139659|147516199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.337|STANDARD_ERROR_OF_MEAN|0.231||||90.0|-0.717|0.042|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.042|-0.717|
73985375|NCT00139659|147516199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.789|STANDARD_ERROR_OF_MEAN|0.238||||90.0|-1.181|-0.397|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.397|-1.181|
73985376|NCT00139659|147516199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.238||||90.0|-1.178|-0.393|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.393|-1.178|
73874970|NCT02294058|147291636|SUPERIORITY||Rate Ratio|0.518|||<|0.0001|TWO_SIDED|95.0|0.405|0.663||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson regression model|Adjusted for region, Baseline age, number of gadolinium enhancing (GdE) lesions and included the natural log transformation of time as an offset term.||||0.663|0.405|<0.0001
73874971|NCT02294058|147291636|SUPERIORITY||Rate Ratio|0.688||||0.0013|TWO_SIDED|95.0|0.547|0.864||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson Regression Model|Adjusted for region, Baseline age and the number of GdE lesions, and included the natural log transformation of time on study as an offset term.||||0.864|0.547|0.0013
73874972|NCT02294058|147291637|SUPERIORITY||Rate Ratio|0.517|||<|0.0001|TWO_SIDED|95.0|0.427|0.625||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.625|0.427|<0.0001
73985377|NCT00139659|147516202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.066|0.023|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.023|-0.066|
73985378|NCT00139659|147516202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.044|0.044|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.044|-0.044|
73985379|NCT00139659|147516202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.056|0.032|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.032|-0.056|
73985380|NCT00139659|147516202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.048|0.041|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.041|-0.048|
73985381|NCT00139659|147516202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.089|-0.001|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.001|-0.089|
74034249|NCT00958308|147621433|SUPERIORITY_OR_OTHER||||||=|0.02|||||||Fisher Exact|||The sample size calculation was based on the incidence of AAD. A total of 255 patients was enrolled in order to obtain at least the required 225 evaluable patients.With expected AAD rates of at most 15% - 25% in the treatment groups; and 25% - 35% in the placebo group, these numbers were sufficient to detect the difference in the incidence of AAD between either of the treatment groups vs. placebo with a minimum of 86% statistical power.||||=0.02
74034250|NCT02227329|147621444|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
74039554|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.27||||0.1389|TWO_SIDED|95.0|0.93|1.73|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.73|0.93|0.1389
73985382|NCT00139659|147516202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.035|0.056|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.056|-0.035|
73874973|NCT02294058|147291637|SUPERIORITY||Rate Ratio|0.754||||0.0032|TWO_SIDED|95.0|0.625|0.91||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.910|0.625|0.0032
73874974|NCT02294058|147291638|SUPERIORITY||Rate Ratio|0.37|||<|0.0001|TWO_SIDED|95.0|0.256|0.536||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.||||0.536|0.256|<0.0001
73985383|NCT00139659|147516202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.028|0.064|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.064|-0.028|
73985384|NCT00139659|147516202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.051|0.041|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.041|-0.051|
73985385|NCT00139659|147516202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.029||||90.0|-0.07|0.026|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.026|-0.070|
73985386|NCT00139659|147516202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.03||||90.0|-0.064|0.034|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.034|-0.064|
73874975|NCT02294058|147291638|SUPERIORITY||Rate Ratio|0.662||||0.0182|TWO_SIDED|95.0|0.471|0.932||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.||||0.932|0.471|0.0182
73874976|NCT02294058|147291639|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.3055|TWO_SIDED|95.0|0.34|1.402|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age, and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||1.402|0.340|0.3055
73874977|NCT02294058|147291639|SUPERIORITY||Hazard Ratio (HR)|0.886||||0.7163|TWO_SIDED|95.0|0.46|1.705|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||1.705|0.460|0.7163
73985387|NCT00139659|147516202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.031||||90.0|-0.067|0.037|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.037|-0.067|
73985388|NCT00139659|147516203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.632|STANDARD_ERROR_OF_MEAN|0.697||||90.0|-1.778|0.514|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.514|-1.778|
73985389|NCT00139659|147516203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-1.079|1.12|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.120|-1.079|
73985390|NCT00139659|147516203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.679||||90.0|-0.535|1.7|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.700|-0.535|
73985391|NCT00139659|147516203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.687||||90.0|-1.184|1.077|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.077|-1.184|
73985392|NCT00139659|147516203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.535|STANDARD_ERROR_OF_MEAN|0.694||||90.0|-1.677|0.608|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.608|-1.677|
74034251|NCT03492463|147621466|SUPERIORITY|||||||0.01|||||||Regression, Linear|||Due to time and budget constraints a blinded decision was made and approved by the funding agency to limit further enrollment to the two conditions that provided nicotine patches. The primary (one-tailed) test compared Nicotine e-cigs + Nicotine patches to Non-nicotine e-cigs + Nicotine patches.||||0.01
74034252|NCT03492463|147621467|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
74034253|NCT03492463|147621468|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
74034254|NCT06704178|147621470|SUPERIORITY|||||||0.488445|||||||Multiple t-tests|||||||0.488445
74034255|NCT06704178|147621471|SUPERIORITY|Between-group comparison.||||||0.98317||||||Between-group comparison.|t-test, 2 sided|||||||0.98317
73985393|NCT00139659|147516203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.905|STANDARD_ERROR_OF_MEAN|0.674||||90.0|-2.014|0.203|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.203|-2.014|
73985394|NCT00139659|147516203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.675||||90.0|-0.899|1.323|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.323|-0.899|
73985395|NCT00139659|147516203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.683||||90.0|-1.08|1.169|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.169|-1.080|
73985396|NCT00139659|147516203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.694||||90.0|-1.382|0.902|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.902|-1.382|
73985397|NCT00139659|147516203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.711||||90.0|-1.673|0.668|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.668|-1.673|
73985398|NCT00139659|147516217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.216||||90.0|-0.858|-0.148|||Longitudinal data analysis model|Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.|Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.||-0.148|-0.858|
73985399|NCT00139659|147516221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.1||||90.0|-0.06|0.28|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.28|-0.06|
73985400|NCT00139659|147516221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.1||||90.0|0.04|0.38|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.38|0.04|
73985401|NCT00139659|147516221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.01|0.34|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.34|-0.01|
73985402|NCT00139659|147516221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.03|0.32|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.32|-0.03|
73985403|NCT00139659|147516221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.12|0.24|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.24|-0.12|
73985404|NCT00139659|147516221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.12||||90.0|-0.19|0.22|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.22|-0.19|
73985405|NCT00139659|147516222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.615|STANDARD_ERROR_OF_MEAN|7.874||||90.0|-2.351|23.581|||Mixed Models Analysis|Confidence interval for the LS mean of that particular treatment.||Week 6; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||23.581|-2.351|
73985406|NCT00139659|147516222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.942|STANDARD_ERROR_OF_MEAN|7.804||||90.0|-19.79|5.909|||Mixed Models Analysis|||Week 12; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||5.909|-19.79|
73985407|NCT00139659|147516222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.622|STANDARD_ERROR_OF_MEAN|7.897||||90.0|-17.63|8.382|||Mixed Models Analysis|||Week 26; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||8.382|-17.63|
73985408|NCT00139659|147516222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.828|STANDARD_ERROR_OF_MEAN|7.888||||90.0|-11.16|14.817|||Mixed Models Analysis|||Week 39; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||14.817|-11.16|
73985409|NCT00139659|147516222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.149|STANDARD_ERROR_OF_MEAN|7.991||||90.0|-12.01|14.307|||Mixed Models Analysis|||Week 52; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||14.307|-12.01|
74034256|NCT06704178|147621472|SUPERIORITY|||||||0.98317|||||||t-test, 2 sided|||||||0.98317
74034257|NCT06704178|147621473|SUPERIORITY|||||||0.919209|||||||t-test, 2 sided|||||||0.919209
74089699|NCT03545191|147732302|OTHER||LS mean difference to placebo|-11.86|||<|0.0001|TWO_SIDED|95.0|-17.494|-6.23||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 25 mg vs placebo).||-6.23|-17.494|<0.0001
74089700|NCT03545191|147732302|OTHER||LS mean difference to placebo|-18.3|||<|0.0001|TWO_SIDED|95.0|-23.945|-12.661||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 50 mg vs placebo).||-12.661|-23.945|<0.0001
74089701|NCT03545191|147732303|OTHER||LS mean difference to placebo|-8.32||||0.0005|TWO_SIDED|95.0|-13.014|-3.629||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||-3.629|-13.014|0.0005
74089702|NCT03545191|147732303|OTHER||LS mean difference to placebo|-11.35|||<|0.0001|TWO_SIDED|95.0|-16.022|-6.687||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 50 mg vs placebo).||-6.687|-16.022|<0.0001
73985410|NCT00139659|147516222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.247|STANDARD_ERROR_OF_MEAN|7.816||||90.0|-8.664|17.157|||Mixed Models Analysis|||Week 52 (LOCF); Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||17.157|-8.664|
73985411|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.455||||90.0|-1.829|-0.331|||Mixed Models Analysis|||Week 1; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.331|-1.829|
73985412|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.475|STANDARD_ERROR_OF_MEAN|0.461||||90.0|-1.233|0.284|||Mixed Models Analysis|||Week 2; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.284|-1.233|
73985413|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.185|STANDARD_ERROR_OF_MEAN|0.454||||90.0|-0.931|0.562|||Mixed Models Analysis|||Week 3; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.562|-0.931|
74089703|NCT03545191|147732304|OTHER||LS mean difference to placebo|-7.59||||0.0015|TWO_SIDED|95.0|-12.265|-2.923||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||-2.923|-12.265|0.0015
73874978|NCT02294058|147291640|SUPERIORITY||Hazard Ratio (HR)|1.238||||0.6725|TWO_SIDED|95.0|0.46|3.337|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||3.337|0.460|0.6725
73874979|NCT02294058|147291640|SUPERIORITY||Hazard Ratio (HR)|1.535||||0.3755|TWO_SIDED|95.0|0.595|3.963|||Cox proportional hazard model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||3.963|0.595|0.3755
73985414|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.189|STANDARD_ERROR_OF_MEAN|0.449||||90.0|-0.929|0.55|||Mixed Models Analysis|||Week 4; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.550|-0.929|
73985415|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.447||||90.0|-1.294|0.178|||Mixed Models Analysis|||Week 6; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.178|-1.294|
73985416|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.748|STANDARD_ERROR_OF_MEAN|0.467||||90.0|-1.517|0.022|||Mixed Models Analysis|||Week 9; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.022|-1.517|
73985417|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.053|STANDARD_ERROR_OF_MEAN|0.886||||90.0|-2.51|0.405|||Mixed Models Analysis|||Week 11; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.405|-2.510|
74089704|NCT03545191|147732304|OTHER||LS mean difference to placebo|-11.67|||<|0.0001|TWO_SIDED|95.0|-16.348|-6.994||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 50 mg vs placebo).||-6.994|-16.348|<0.0001
74089705|NCT03545191|147732305|OTHER||LS mean difference to placebo|12.62|||=|0.0013|TWO_SIDED|95.0|4.953|20.288||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||20.288|4.953|= 0.0013
73874980|NCT02294058|147291641|SUPERIORITY||Difference in Percentages|10.88||||0.0006|TWO_SIDED|95.0|4.84|16.92|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS category per Interactive Voice Response System (IVRS)||||16.92|4.84|0.0006
73985418|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.891|STANDARD_ERROR_OF_MEAN|0.451||||90.0|-1.634|-0.149|||Mixed Models Analysis|||Week 12; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.149|-1.634|
73985419|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.453||||90.0|-1.725|-0.234|||Mixed Models Analysis|||Week 18; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.234|-1.725|
73985420|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.663|STANDARD_ERROR_OF_MEAN|0.448||||90.0|-1.4|0.075|||Mixed Models Analysis|||Week 26; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.075|-1.400|
73985421|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.537|STANDARD_ERROR_OF_MEAN|0.451||||90.0|-1.279|0.205|||Mixed Models Analysis|||Week 39; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.205|-1.279|
73985422|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.322|STANDARD_ERROR_OF_MEAN|1.027||||90.0|-3.012|0.369|||Mixed Models Analysis|||Week 50; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.369|-3.012|
73985423|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.552||||90.0|-0.847|0.972|||Mixed Models Analysis|||Week 51; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.972|-0.847|
73985424|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193|STANDARD_ERROR_OF_MEAN|0.469||||90.0|-0.964|0.579|||Mixed Models Analysis|||Week 52; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.579|-0.964|
73985425|NCT00139659|147516223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.526||||90.0|-1.298|0.438|||Mixed Models Analysis|||Week 52 (LOCF); adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.438|-1.298|
73985426|NCT00139659|147516231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.079|0.0|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.000|-0.079|
73985427|NCT00139659|147516231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.068|0.01|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.010|-0.068|
73985428|NCT00139659|147516231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.084|-0.006|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.006|-0.084|
73985429|NCT00139659|147516231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.007|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.007|-0.085|
74034258|NCT06704178|147621474|SUPERIORITY|||||||0.919209|||||||t-test, 2 sided|||||||0.919209
74034259|NCT06704178|147621475|SUPERIORITY|||||||0.954882||||||Comparison at Month 2|t-test, 2 sided|||||||0.954882
74034260|NCT06704178|147621475|SUPERIORITY|||||||0.246176||||||Comparison at Month 4|t-test, 2 sided|||||||0.246176
73874981|NCT02294058|147291641|SUPERIORITY||Difference in Percentages|5.12||||0.113|TWO_SIDED|95.0|-1.07|11.32|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS category per IVRS.||||11.32|-1.07|0.1130
73874982|NCT02294058|147291642|SUPERIORITY||Difference in Percentages|4.53||||0.118|TWO_SIDED|95.0|-1.19|10.24|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS Scale category per IVRS.||||10.24|-1.19|0.1180
73985430|NCT00139659|147516231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.007|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.007|-0.085|
73985431|NCT00139659|147516231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.063|0.017|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.017|-0.063|
74034261|NCT06704178|147621475|SUPERIORITY|||||||0.954882||||||Comparison at Month 6|t-test, 2 sided|||||||0.954882
74034262|NCT06704178|147621476|SUPERIORITY|||||||0.483382||||||Comparison at Month 2|t-test, 2 sided|||||||0.483382
74034263|NCT06704178|147621476|SUPERIORITY|||||||0.483382||||||Comparison at Month 4|t-test, 2 sided|||||||0.483382
74034264|NCT06704178|147621476|SUPERIORITY|||||||0.726742||||||Comparison at Month 6|t-test, 2 sided|||||||0.726742
74034265|NCT06704178|147621477|SUPERIORITY|||||||0.999216||||||Comparison at Month 1|t-test, 2 sided|||||||0.999216
74034266|NCT06704178|147621477|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
74034267|NCT06704178|147621477|SUPERIORITY|||||||0.559556||||||Comparison at Month 3|t-test, 2 sided|||||||0.559556
74034268|NCT06704178|147621477|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
74034269|NCT06704178|147621477|SUPERIORITY|||||||0.952545||||||Comparison at Month 5|t-test, 2 sided|||||||0.952545
73874983|NCT02294058|147291642|SUPERIORITY||Difference in percentages|2.95||||0.3023|TWO_SIDED|95.0|-2.7|8.6|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS Scale category per IVRS.||||8.60|-2.70|0.3023
73985432|NCT00139659|147516231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.062|0.02|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.020|-0.062|
73985433|NCT00139659|147516231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.055|0.027|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.027|-0.055|
73985434|NCT00139659|147516231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.085|0.0|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.000|-0.085|
73985435|NCT00139659|147516231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.109|-0.022|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.022|-0.109|
73985436|NCT00139659|147516231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.097|-0.003|||Mixed Models Analysis|||Week 52 Last Observation Carried Forward (LOCF; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.003|-0.097|
73985437|NCT00139659|147516232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.279|STANDARD_ERROR_OF_MEAN|0.199||||90.0|-0.606|0.048|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.048|-0.606|
73985438|NCT00139659|147516232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.336|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.661|-0.011|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.011|-0.661|
73985439|NCT00139659|147516232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.384|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.707|-0.061|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.061|-0.707|
73985440|NCT00139659|147516232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.516|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.842|-0.191|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.191|-0.842|
73985441|NCT00139659|147516232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.474|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.797|-0.152|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.152|-0.797|
73985442|NCT00139659|147516232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.202||||90.0|-0.866|-0.2|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.200|-0.866|
73985443|NCT00139659|147516232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.509|STANDARD_ERROR_OF_MEAN|0.204||||90.0|-0.845|-0.174|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.174|-0.845|
73985444|NCT00139659|147516232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.412|STANDARD_ERROR_OF_MEAN|0.204||||90.0|-0.749|-0.076|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.076|-0.749|
73985445|NCT00139659|147516232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.707|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-1.056|-0.358|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.358|-1.056|
73874984|NCT02294058|147291643|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and EDSS category per IVRS||Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.||||<0.0001
74034270|NCT06704178|147621477|SUPERIORITY|||||||0.998367||||||Comparison at Month 6|t-test, 2 sided|||||||0.998367
74034271|NCT06704178|147621478|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
74034272|NCT06704178|147621478|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
74034273|NCT06704178|147621478|SUPERIORITY|||||||0.999801|||||||t-test, 2 sided|||||||0.999801
74034274|NCT06704178|147621478|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
74034275|NCT06704178|147621478|SUPERIORITY|||||||0.993223||||||Comparison at Month 5|t-test, 2 sided|||||||0.993223
73874985|NCT02294058|147291643|SUPERIORITY|||||||0.0615|||||||Rank ANCOVA|Adjusted for region and EDSS Scale per IVRS||Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.||||0.0615
73874986|NCT02294058|147291644|SUPERIORITY||LS Mean Difference|0.034||||0.129|TWO_SIDED|95.0|-0.01|0.077|||ANCOVA|Adjusted for region, EDSS category per IVRS and the Baseline MSFC score.||||0.077|-0.010|0.1290
73874987|NCT02294058|147291644|SUPERIORITY||LS Mean Difference|0.015||||0.4942|TWO_SIDED|95.0|-0.028|0.059|||ANCOVA|Adjusted for region, EDSS category per IVRS and the Baseline MSFC score||||0.059|-0.028|0.4942
73874988|NCT02294058|147291645|SUPERIORITY||Mean Difference (Final Values)|1.642||||0.0364|TWO_SIDED|95.0|0.104|3.18|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Physical Health Composite Summary||3.180|0.104|0.0364
73874989|NCT02294058|147291645|SUPERIORITY||Mean Difference (Final Values)|1.024||||0.1905|TWO_SIDED|95.0|-0.51|2.559|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Physical Health Composite Summary||2.559|-0.510|0.1905
73985446|NCT00139659|147516232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.219||||90.0|-1.04|-0.32|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.320|-1.040|
73985447|NCT00139659|147516232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.765|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-1.116|-0.415|||Mixed Models Analysis|||Week 52 Last Observation Carried Forward (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.415|-1.116|
73985448|NCT02391116|147516243|OTHER||Percentage Difference|2.2|||||TWO_SIDED|90.0|-28.7|32.9|||Exact confidence intervals (CI)||ORR difference in FAS (N=54): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup|||32.9|-28.7|
74034276|NCT06704178|147621478|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
74034277|NCT06704178|147621479|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
74034278|NCT06704178|147621479|SUPERIORITY|||||||0.999838||||||Comparison at Month 2|t-test, 2 sided|||||||0.999838
73874990|NCT02294058|147291645|SUPERIORITY||Mean Difference (Final Values)|0.356||||0.7104|TWO_SIDED|95.0|-1.523|2.234|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Mental Health Composite Summary||2.234|-1.523|0.7104
73874991|NCT02294058|147291645|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.8587|TWO_SIDED|95.0|-2.045|1.705|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Mental Health Composite Summary||1.705|-2.045|0.8587
73874992|NCT01332994|147291699|SUPERIORITY_OR_OTHER|||||||0.1648|TWO_SIDED|||||Exact one-sided binomial test on single proportions with a significance level of alpha equals (=) 0.025. Null hypothesis: Proportion of participants reaching DAS28 remission (\<2.6) at Week 16 is ≤45 percent (%).|Exact one-sided binomial test|||||||0.1648
73874993|NCT01332994|147291735|SUPERIORITY_OR_OTHER|||||||0.7559|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Naive B-cell compartment||||0.7559
73874994|NCT01332994|147291735|SUPERIORITY_OR_OTHER|||||||0.8961|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Transitional B-cells||||0.8961
73874995|NCT01332994|147291735|SUPERIORITY_OR_OTHER|||||||0.7915|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Naive B-cells||||0.7915
73874996|NCT01332994|147291735|SUPERIORITY_OR_OTHER|||||||0.8081|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Memory B-cells||||0.8081
73874997|NCT01332994|147291735|SUPERIORITY_OR_OTHER|||||||0.6574|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Pre-switch memory B-cells||||0.6574
73874998|NCT01332994|147291735|SUPERIORITY_OR_OTHER|||||||0.4553|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Post-switch memory B-cells||||0.4553
73874999|NCT01332994|147291735|SUPERIORITY_OR_OTHER|||||||0.2215|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||IgG-positive class-switched B-cells||||0.2215
73875000|NCT01332994|147291735|SUPERIORITY_OR_OTHER|||||||0.886|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||IgA-positive class-switched B-cells||||0.8860
73875001|NCT01332994|147291735|SUPERIORITY_OR_OTHER|||||||0.8693|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Double-negative B-cells||||0.8693
73985449|NCT02391116|147516243|OTHER||Percentage Difference|0.0|||||TWO_SIDED|90.0|-33.5|33.5|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup|||33.5|-33.5|
74034279|NCT06704178|147621479|SUPERIORITY|||||||0.991697||||||Comparison at Month 3|t-test, 2 sided|||||||0.991697
74034280|NCT06704178|147621479|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
74034281|NCT06704178|147621479|SUPERIORITY|||||||0.581904||||||Comparison at Month 5|t-test, 2 sided|||||||0.581904
74034282|NCT06704178|147621479|SUPERIORITY|||||||0.999866||||||Comparison at Month 6|t-test, 2 sided|||||||0.999866
74034283|NCT06704178|147621480|SUPERIORITY|||||||0.999835||||||Comparison at Month 1|t-test, 2 sided|||||||0.999835
74034284|NCT06704178|147621480|SUPERIORITY|||||||0.962016||||||Comparison at Month 2|t-test, 2 sided|||||||0.962016
73875002|NCT01332994|147291735|SUPERIORITY_OR_OTHER|||||||0.9564|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Plasmablasts||||0.9564
73875003|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.9993|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cell compartment||||0.9993
73875004|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.3596|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Transitional B-cells||||0.3596
73875005|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.7435|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cells||||0.7435
73875006|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.7671|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Memory B-cells||||0.7671
73985450|NCT02391116|147516244|OTHER||Percentage Difference|16.4|||||TWO_SIDED|90.0|-7.2|39.1|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)|||39.1|-7.2|
73875007|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.7912|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Pre-switch memory B-cells||||0.7912
73985451|NCT02391116|147516244|OTHER||Percentage Difference|20.8|||||TWO_SIDED|90.0|-6.8|46.2|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)|||46.2|-6.8|
73985452|NCT02391116|147516244|OTHER||Percentage Difference|-18.5|||||TWO_SIDED|90.0|-40.1|4.6|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)|||4.6|-40.1|
73985453|NCT02391116|147516244|OTHER||Percentage Difference|-25.3|||||TWO_SIDED|90.0|-49.1|1.1|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)|||1.1|-49.1|
73985454|NCT02391116|147516244|OTHER||Percentage Difference|12.9|||||TWO_SIDED|90.0|-42.4|63.2|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)|||63.2|-42.4|
73985455|NCT02391116|147516244|OTHER||Percentage Difference|26.3|||||TWO_SIDED|90.0|-44.3|77.6|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)|||77.6|-44.3|
73875008|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.5595|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Post-switch memory B-cells||||0.5595
73875009|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.3817|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgG-positive class-switched B-cells||||0.3817
73875010|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.3623|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgA-positive class-switched B-cells||||0.3623
73875011|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.7108|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Double-negative B-cells||||0.7108
73875012|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.0639|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Plasmablasts||||0.0639
73875013|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.0186|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Naive B-cell compartment||||0.0186
73875014|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Transitional B-cells||||0.0050
73875015|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.0463|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Naive B-cells||||0.0463
73985456|NCT01747629|147516263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.163|<|0.0001|TWO_SIDED|95.0|0.59|1.24||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.24|0.59|<0.0001
73875016|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.1919|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Memory B-cells||||0.1919
73985457|NCT01747629|147516264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|0.56|1.55||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.55|0.56|<0.0001
74034285|NCT06704178|147621480|SUPERIORITY|||||||0.995044||||||Comparison at Month 3|t-test, 2 sided|||||||0.995044
74034286|NCT06704178|147621480|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
73985458|NCT01747629|147516265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.212||0.0004|TWO_SIDED|95.0|0.35|1.19||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.19|0.35|0.0004
73985459|NCT01747629|147516266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|0.57|1.28||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.28|0.57|<0.0001
73985460|NCT04414397|147516277|SUPERIORITY||Rate Difference|66.9|||<|0.0001|TWO_SIDED|95.0|54.9|78.8||Analysis was performed using the SAS procedure MIANALYZE with normal approximation to generate an associated p-value for the comparison of responder rates between groups.|Multiple imputation regression|||JUVÉDERM® VOLUMA® XC Treatment vs No-treatment control||78.8|54.9|<0.0001
73985461|NCT04414397|147516281|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 visit is statistically greater than at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
73985462|NCT04414397|147516282|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 is statistically greater than at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
73985463|NCT01261793|147516307|SUPERIORITY||Odds Ratio (OR)|1.024|||=|0.899|TWO_SIDED|95.0|0.71|1.477||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|||1.477|0.710|=0.899
73985464|NCT01261793|147516307|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.716|TWO_SIDED|95.0|0.743|1.539||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|||1.539|0.743|=0.716
73985465|NCT03740919|147516365|NON_INFERIORITY|Noninferiority margin \[NIM\]=0.4% for HbA1c|Least Squares (LS) Mean Difference|-0.02||||0.783|TWO_SIDED|95.0|-0.17|0.13|||Mixed Models Analysis|||||0.13|-0.17|0.783
73985466|NCT03740919|147516366|NON_INFERIORITY|NIM of 0.4%|LS Mean Difference|-0.02||||0.867|TWO_SIDED|95.0|-0.2|0.17|||Mixed Models Analysis|||||0.17|-0.20|0.867
73985467|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|1.61||||0.008|TWO_SIDED|95.0|1.13|2.3|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||2.30|1.13|0.008
73985468|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|1.17||||0.487|TWO_SIDED|95.0|0.75|1.83|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||1.83|0.75|0.487
73985469|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|0.73||||0.153|TWO_SIDED|95.0|0.47|1.13|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||1.13|0.47|0.153
73985470|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|1.49||||0.02|TWO_SIDED|95.0|1.06|2.08|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||2.08|1.06|0.020
73985471|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|1.17||||0.455|TWO_SIDED|95.0|0.78|1.76|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||1.76|0.78|0.455
73985472|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|0.79||||0.259|TWO_SIDED|95.0|0.52|1.19|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||1.19|0.52|0.259
73985473|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.29|2.51|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||2.51|1.29|<0.001
73985474|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|0.95||||0.822|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||1.43|0.64|0.822
73985475|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|0.53||||0.003|TWO_SIDED|95.0|0.35|0.8|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||0.80|0.35|0.003
73985476|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|1.42||||0.092|TWO_SIDED|95.0|0.94|2.14|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||2.14|0.94|0.092
73985477|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|0.71||||0.133|TWO_SIDED|95.0|0.45|1.11|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||1.11|0.45|0.133
73985478|NCT03740919|147516367|SUPERIORITY||Odds Ratio (OR)|0.5||||0.004|TWO_SIDED|95.0|0.31|0.8|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||0.80|0.31|0.004
73985479|NCT03740919|147516368|SUPERIORITY|||||||0.22|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.220
73985480|NCT03740919|147516368|SUPERIORITY|||||||0.599|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.599
73985481|NCT03740919|147516368|SUPERIORITY|||||||0.112|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.112
74034287|NCT06704178|147621480|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
73875017|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.3071|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Pre-switch memory B-cells||||0.3071
73875018|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.1714|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Post-switch memory B-cells||||0.1714
73875019|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.1746|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, IgG-positive class-switched B-cells||||0.1746
73875020|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.1626|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, IgA-positive class-switched B-cells||||0.1626
73875021|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.6304|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Double-negative B-cells||||0.6304
73875022|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.3449|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Plasmablasts||||0.3449
73985482|NCT03740919|147516368|SUPERIORITY|||||||0.034|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.034
73985483|NCT03740919|147516368|SUPERIORITY|||||||0.055|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.055
73985484|NCT03740919|147516368|SUPERIORITY|||||||0.814|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.814
73875023|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.0919|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Naive B-cell compartment||||0.0919
73875024|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.2189|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Transitional B-cells||||0.2189
73875025|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.1386|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Naive B-cells||||0.1386
73875026|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.6199|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Memory B-cells||||0.6199
73875027|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.1019|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Pre-switch memory B-cells||||0.1019
73875028|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.4353|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Post-switch memory B-cells||||0.4353
73875029|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.3934|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, IgG-positive class-switched B-cells||||0.3934
73875030|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.4196|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, IgA-positive class-switched B-cells||||0.4196
73875031|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.5546|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Double-negative B-cells||||0.5546
73875032|NCT01332994|147291736|SUPERIORITY_OR_OTHER|||||||0.7695|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Plasmablasts||||0.7695
73875033|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.6551|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cell compartment||||0.6551
73875034|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.6905|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Transitional B-cells||||0.6905
73875035|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.9678|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cells||||0.9678
73875036|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Memory B-cells||||0.2080
73985485|NCT03740919|147516368|SUPERIORITY|||||||0.194|||||||Negative binomial regression|||≤70 mg/dL 1 hour post-dose||||0.194
73985486|NCT03740919|147516368|SUPERIORITY|||||||0.428|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 1 hour post-dose||||0.428
73985487|NCT03740919|147516368|SUPERIORITY|||||||0.057|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 1 hour post-dose||||0.057
74034288|NCT06704178|147621480|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
74089706|NCT03545191|147732305|OTHER||LS mean difference to placebo|22.06|||<|0.0001|TWO_SIDED|95.0|14.405|29.708||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||29.708|14.405|< 0.0001
73985488|NCT03740919|147516368|SUPERIORITY|||||||0.056|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model||≤70 mg/dL 2 hour post-dose||||0.056
73985489|NCT03740919|147516368|SUPERIORITY|||||||0.435|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 2 hour post-dose||||0.435
73985490|NCT03740919|147516368|SUPERIORITY|||||||0.404|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 2 hour post-dose||||0.404
73985491|NCT03740919|147516369|SUPERIORITY||Odds Ratio (OR)|1.04||||0.864|TWO_SIDED|95.0|0.68|1.57|||Regression, Logistic|||\<54 mg/dL||1.57|0.68|0.864
73985492|NCT03740919|147516369|SUPERIORITY||Odds Ratio (OR)|0.69||||0.132|TWO_SIDED|95.0|0.43|1.12|||Regression, Logistic|||\<54 mg/dL||1.12|0.43|0.132
73985493|NCT03740919|147516369|SUPERIORITY||Odds Ratio (OR)|0.67||||0.104|TWO_SIDED|95.0|0.41|1.09|||Regression, Logistic|||||1.09|0.41|0.104
73985494|NCT03740919|147516369|SUPERIORITY||Odds Ratio (OR)|0.8||||0.489|TWO_SIDED|95.0|0.42|1.52|||Regression, Logistic|||≤70 mg/dL||1.52|0.42|0.489
73985495|NCT03740919|147516369|SUPERIORITY||Odds Ratio (OR)|0.45||||0.025|TWO_SIDED|95.0|0.23|0.9|||Regression, Logistic|||≤70 mg/dL||0.90|0.23|0.025
73985496|NCT03740919|147516369|SUPERIORITY||Odds Ratio (OR)|0.57||||0.099|TWO_SIDED|95.0|0.29|1.11|||Regression, Logistic|||≤70 mg/dL||1.11|0.29|0.099
73985497|NCT03740919|147516370|SUPERIORITY|||||||0.732|||||||Negative binomial regression|||\< 54 mg/dL||||0.732
73985498|NCT03740919|147516370|SUPERIORITY|||||||0.638|||||||Negative binomial regression|||\< 54 mg/dL||||0.638
73985499|NCT03740919|147516370|SUPERIORITY|||||||0.462|||||||Negative binomial regression|||\<54 mg/dL||||0.462
73985500|NCT03740919|147516370|SUPERIORITY|||||||0.632|||||||Negative binomial regression|||≤ 70 mg/dL||||0.632
73985501|NCT03740919|147516370|SUPERIORITY|||||||0.8|||||||Negative binomial regression|||≤ 70 mg/dL||||0.800
73985502|NCT03740919|147516370|SUPERIORITY|||||||0.889|||||||Negative binomial regression|||≤ 70 mg/dL||||0.889
73985503|NCT03740919|147516372|SUPERIORITY||LS Mean Difference|0.6||||0.13|TWO_SIDED|95.0|-0.2|1.4|||Mixed Models Analysis|||Total Daily Basal Insulin||1.4|-0.2|0.130
73985504|NCT03740919|147516372|SUPERIORITY||LS Mean Difference|0.4||||0.404|TWO_SIDED|95.0|-0.5|1.4|||Mixed Models Analysis|||Total Daily Basal Insulin||1.4|-0.5|0.404
73985505|NCT03740919|147516372|SUPERIORITY||LS Mean Difference|-0.2||||0.693|TWO_SIDED|95.0|-1.2|0.8|||Mixed Models Analysis|||Total Daily Basal Insulin||0.8|-1.2|0.693
73985506|NCT03740919|147516372|SUPERIORITY||LS Mean Difference|0.5||||0.625|TWO_SIDED|95.0|-1.4|2.3|||Mixed Models Analysis|||Total Daily Insulin Dose||2.3|-1.4|0.625
73875037|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.4778|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Pre-switch memory B-cells||||0.4778
73985507|NCT03740919|147516372|SUPERIORITY||LS Mean Difference|-0.4||||0.758|TWO_SIDED|95.0|-2.6|1.9|||Mixed Models Analysis|||Total Daily Insulin Dose||1.9|-2.6|0.758
73985508|NCT03740919|147516372|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.485|TWO_SIDED|95.0|-3.1|1.5|||Mixed Models Analysis|||Total Daily Insulin Dose||1.5|-3.1|0.485
73985509|NCT03740919|147516373|SUPERIORITY||Odds Ratio (OR)|1.23||||0.396|TWO_SIDED|95.0|0.76|2.0|||Regression, Logistic|||HbA1c \< 7%||2.00|0.76|0.396
73985510|NCT03740919|147516373|SUPERIORITY||Odds Ratio (OR)|0.93||||0.814|TWO_SIDED|95.0|0.49|1.75|||Regression, Logistic|||HbA1c \< 7%||1.75|0.49|0.814
73985511|NCT03740919|147516373|SUPERIORITY||Odds Ratio (OR)|0.75||||0.384|TWO_SIDED|95.0|0.39|1.43|||Regression, Logistic|||HbA1c \< 7%||1.43|0.39|0.384
73985512|NCT03740919|147516373|SUPERIORITY||Odds Ratio (OR)|0.84||||0.4|TWO_SIDED|95.0|0.55|1.27|||Regression, Logistic|||HbA1c \< 7.5%||1.27|0.55|0.400
73985513|NCT03740919|147516373|SUPERIORITY||Odds Ratio (OR)|0.62||||0.094|TWO_SIDED|95.0|0.36|1.08|||Regression, Logistic|||HbA1c \< 7.5%||1.08|0.36|0.094
73985514|NCT03740919|147516373|SUPERIORITY||Odds Ratio (OR)|0.75||||0.306|TWO_SIDED|95.0|0.43|1.31|||Regression, Logistic|||HbA1c \< 7.5%||1.31|0.43|0.306
73985515|NCT03873038|147516389|OTHER|Geometric mean ratio (GMR) was derived using the geometric mean (GM) for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).|GMR|0.8|||||TWO_SIDED|90.0|0.54|1.18|||||GMR=GM ESRD/GM Healthy|||1.18|0.54|
73985516|NCT03873038|147516389|OTHER|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).|GMR|0.53|||||TWO_SIDED|90.0|0.37|0.76|||||GMR=GM ESRD/GM Healthy|||0.76|0.37|
73985517|NCT03873038|147516389|OTHER||GMR|0.82|||||TWO_SIDED|90.0|0.55|1.21|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.21|0.55|
73985518|NCT03873038|147516390|OTHER||GMR|1.41|||||TWO_SIDED|90.0|1.07|1.85|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.85|1.07|
73985519|NCT03873038|147516390|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.67|1.11|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001)||1.11|0.67|
73985520|NCT03873038|147516390|OTHER||GMR|0.82|||||TWO_SIDED|90.0|0.62|1.08|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.08|0.62|
73985521|NCT03873038|147516391|OTHER||GMR|1.11|||||TWO_SIDED|90.0|0.84|1.46|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.46|0.84|
73985522|NCT03873038|147516391|OTHER||GMR|0.68|||||TWO_SIDED|90.0|0.52|0.87|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||0.87|0.52|
73985523|NCT03873038|147516391|OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.6|1.03|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.03|0.60|
73985524|NCT03873038|147516392|OTHER||GMR|1.5|||||TWO_SIDED|90.0|1.05|2.14|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||2.14|1.05|
73985525|NCT03873038|147516392|OTHER||GMR|0.91|||||TWO_SIDED|90.0|0.67|1.25|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.25|0.67|
73985526|NCT03873038|147516392|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.62|1.2|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.20|0.62|
73985527|NCT04783519|147516434|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.39||||0.004|TWO_SIDED|95.0|-0.65|-0.127|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||-0.127|-0.650|.004
73985528|NCT04783519|147516434|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.21||||0.118|TWO_SIDED|95.0|-0.482|0.054|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||.054|-.482|.118
73985529|NCT04783519|147516434|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.41||||0.003|TWO_SIDED|95.0|-0.674|-0.142|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||-0.142|-0.674|.003
73985530|NCT04783519|147516434|SUPERIORITY||beta coefficient|-0.16||||0.24|TWO_SIDED|95.0|-0.428|0.107|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.107|-0.428|.240
73985531|NCT04783519|147516435|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-4.88||||0.003|TWO_SIDED|95.0|-8.1|-1.65|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||-1.65|-8.10|.003
74034289|NCT06704178|147621481|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
73985532|NCT04783519|147516435|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-1.71||||0.308|TWO_SIDED|95.0|-4.98|1.57|||Regression, Linear|Models control for age, sex, race, and ethnicity.||"Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)"||1.57|-4.98|.308
74034290|NCT06704178|147621481|SUPERIORITY|||||||0.999524||||||Comparison at Month 2|t-test, 2 sided|||||||0.999524
73875038|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.8526|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Post-switch memory B-cells||||0.8526
73985533|NCT04783519|147516435|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-4.52||||0.007|TWO_SIDED|95.0|-7.8|-1.25|||Regression, Linear|Models control for age, sex, race, and ethnicity.||"Changes from Baseline to 3 Month for BASICS+SLEEP vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)"||-1.25|-7.8|.007
73985534|NCT04783519|147516435|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.83||||0.621|TWO_SIDED|95.0|-4.12|2.46|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month for BASICS vs. AOC reported in this section. Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/ )||2.46|-4.12|.621
74034291|NCT06704178|147621481|SUPERIORITY|||||||0.576782||||||Comparison at Month 3|t-test, 2 sided|||||||0.576782
73875039|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.7266|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgG-positive class-switched B-cells||||0.7266
73985535|NCT04783519|147516436|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.802||||0.054|TWO_SIDED|95.0|0.641|1.003|||Mixed Models Analysis|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.003|0.641|.054
74034292|NCT06704178|147621481|SUPERIORITY|||||||0.772865||||||Comparison at Month 4|t-test, 2 sided|||||||0.772865
74034293|NCT06704178|147621481|SUPERIORITY|||||||0.91384||||||Comparison at Month 5|t-test, 2 sided|||||||0.91384
74034294|NCT06704178|147621481|SUPERIORITY|||||||0.992841||||||Comparison at Month 6|t-test, 2 sided|||||||0.992841
74034295|NCT06704178|147621482|SUPERIORITY|||||||0.999732||||||Comparison at Month 1|t-test, 2 sided|||||||0.999732
74034296|NCT06704178|147621482|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
74034297|NCT06704178|147621482|SUPERIORITY|||||||0.999801||||||Comparison at Month 3|t-test, 2 sided|||||||0.999801
74034298|NCT06704178|147621482|SUPERIORITY||||||>|0.999999||||||Comparison at Month 4|t-test, 2 sided|||||||>0.999999
73875040|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.2011|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgA-positive class-switched B-cells||||0.2011
73875041|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.7872|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Double-negative B-cells||||0.7872
73985536|NCT04783519|147516436|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.75||||0.015|TWO_SIDED|95.0|0.6|0.946|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.946|0.600|.015
73985537|NCT04783519|147516436|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.736||||0.013|TWO_SIDED|95.0|0.578|0.937|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.937|0.578|.013
73985538|NCT04783519|147516436|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.658||||0.001|TWO_SIDED|95.0|0.513|0.844|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.844|0.513|.001
73985539|NCT04783519|147516437|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.992||||0.96|TWO_SIDED|95.0|0.716|1.374|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.374|0.716|.960
73985540|NCT04783519|147516437|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.782||||0.152|TWO_SIDED|95.0|0.506|1.094|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.094|0.506|.152
73985541|NCT04783519|147516437|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.887||||0.482|TWO_SIDED|95.0|0.634|1.24|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||1.240|0.634|.482
73985542|NCT04783519|147516437|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.67||||0.02|TWO_SIDED|95.0|0.634|1.24|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||1.240|0.634|.020
73985543|NCT04783519|147516438|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.724||||0.032|TWO_SIDED|95.0|0.54|0.973|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.973|0.540|.032
73985544|NCT04783519|147516438|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.588|||<|0.001|TWO_SIDED|95.0|0.432|0.8|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.800|0.432|<.001
74034299|NCT06704178|147621482|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
74034300|NCT06704178|147621482|SUPERIORITY||||||>|0.999999||||||Comparison at Month 6|t-test, 2 sided|||||||>0.999999
74034301|NCT06704178|147621483|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
73875042|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.5377|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Plasmablasts||||0.5377
73875043|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.6238|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Naive B-cell compartment||||0.6238
74034302|NCT06704178|147621483|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
74034303|NCT06704178|147621483|SUPERIORITY|||||||0.998326||||||Comparison at Month 3|t-test, 2 sided|||||||0.998326
74034304|NCT06704178|147621483|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
73875044|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.2848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Transitional B-cells||||0.2848
73875045|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.6238|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Naive B-cells||||0.6238
73875046|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.2848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Pre-switch memory B-cells||||0.2848
74034305|NCT06704178|147621483|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
74034306|NCT06704178|147621483|SUPERIORITY|||||||0.998846||||||Comparison at Month 6|t-test, 2 sided|||||||0.998846
74034307|NCT06704178|147621484|SUPERIORITY|||||||0.999387||||||Comparison at Month 1|t-test, 2 sided|||||||0.999387
74034308|NCT06704178|147621484|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
73875047|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.7471|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Post-switch memory B-cells||||0.7471
73985545|NCT04783519|147516439|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.699||||0.009|TWO_SIDED|95.0|0.535|0.914|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.914|0.535|.009
73985546|NCT04783519|147516439|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.675||||0.005|TWO_SIDED|95.0|0.512|0.888|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.888|0.512|.005
73985547|NCT04783519|147516439|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.698||||0.013|TWO_SIDED|95.0|0.526|0.928|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.928|0.526|.013
73985548|NCT04783519|147516439|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.525|||<|0.001|TWO_SIDED|95.0|0.385|0.715|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.715|0.385|<.001
73985549|NCT04783519|147516440|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.598||||0.01|TWO_SIDED|95.0|0.404|0.885|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.885|0.404|.010
73985550|NCT04783519|147516440|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.502||||0.001|TWO_SIDED|95.0|0.331|0.76|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.760|0.331|.001
73985551|NCT04783519|147516440|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.516||||0.002|TWO_SIDED|95.0|0.337|0.79|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.790|0.337|.002
73985552|NCT04783519|147516440|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.506||||0.002|TWO_SIDED|95.0|0.33|0.774|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.774|0.330|.002
73985553|NCT04783519|147516441|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.628||||0.003|TWO_SIDED|95.0|0.462|0.853|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.853|0.462|.003
73985554|NCT04783519|147516441|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.744||||0.073|TWO_SIDED|95.0|0.538|1.028|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.028|0.538|.073
73985555|NCT04783519|147516441|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.764||||0.09|TWO_SIDED|95.0|0.559|1.043|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.043|0.559|.090
73875048|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.7471|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, IgG-positive class-switched B-cells||||0.7471
73875049|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, IgA-positive class-switched B-cells||||0.3910
73985556|NCT04783519|147516441|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.656||||0.013|TWO_SIDED|95.0|0.469|0.916|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.916|0.469|.013
73985557|NCT04783519|147516442|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.753||||0.087|TWO_SIDED|95.0|0.546|1.041|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.041|0.546|.087
73985558|NCT04783519|147516442|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.739||||0.078|TWO_SIDED|95.0|0.528|1.034|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.034|0.528|.078
74034309|NCT06704178|147621484|SUPERIORITY||||||>|0.999999||||||Comparison at Month 3|t-test, 2 sided|||||||>0.999999
73985559|NCT04783519|147516442|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.773||||0.099|TWO_SIDED|95.0|0.569|1.05|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||1.050|0.569|.099
74034310|NCT06704178|147621484|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
73985560|NCT04783519|147516442|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.704||||0.031|TWO_SIDED|95.0|0.512|0.969|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.969|0.512|.031
73985561|NCT04341584|147516489|SUPERIORITY||Median posterior HR|0.97|||||TWO_SIDED|90.0|0.62|1.52|||Bayesian Cox model|adjusted for age and centre|% Confidence Interval is % Credible Interval here|||1.52|0.62|
73985562|NCT04341584|147516490|SUPERIORITY||Median posterior absolute risk differenc|-2.5|||||TWO_SIDED|90.0|-17.1|12.0|||Bayesian analysis||% Confidence Interval is % Credible Interval here|||12|-17.1|
73985563|NCT04341584|147516491|SUPERIORITY||Median posterior HR|1.26|||||TWO_SIDED|90.0|0.59|2.81||adjusted for age and centre|Bayesian Fine and Gray analysis||% Confidence interval is % Credible Interval here|||2.81|0.59|
73985564|NCT04341584|147516492|SUPERIORITY||Median posterior absolute risk differenc|24.0|||||TWO_SIDED|90.0|3.9|43.5|||Bayesian analysis||% Confidence interval is % Credible interval here|||43.5|3.9|
73985565|NCT04341584|147516493|SUPERIORITY||Median posterior OR|0.8|||||TWO_SIDED|95.0|0.38|1.68|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 4||1.68|0.38|
74034311|NCT06704178|147621484|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
74034312|NCT06704178|147621484|SUPERIORITY|||||||0.998367||||||Comparison at Month 6|t-test, 2 sided|||||||0.998367
74034313|NCT06704178|147621485|SUPERIORITY|||||||0.999975||||||Comparison at Month 1|t-test, 2 sided|||||||0.999975
74034314|NCT06704178|147621485|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
74034315|NCT06704178|147621485|SUPERIORITY|||||||0.999801||||||Comparison at Month 3|t-test, 2 sided|||||||0.999801
74034316|NCT06704178|147621485|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
74034317|NCT06704178|147621485|SUPERIORITY|||||||0.960874||||||Comparison at Month 5|t-test, 2 sided|||||||0.960874
74034318|NCT06704178|147621485|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
74034319|NCT06704178|147621486|SUPERIORITY|||||||0.981906||||||Comparison at Month 1|t-test, 2 sided|||||||0.981906
74034320|NCT06704178|147621486|SUPERIORITY|||||||0.945027||||||Comparison at Month 2|t-test, 2 sided|||||||0.945027
74034321|NCT06704178|147621486|SUPERIORITY|||||||0.767795||||||Comparison at Month 3|t-test, 2 sided|||||||0.767795
74034322|NCT06704178|147621486|SUPERIORITY|||||||0.996139||||||Comparison at Month 4|t-test, 2 sided|||||||0.996139
73985566|NCT04341584|147516493|SUPERIORITY||Median posterior OR|0.69|||||TWO_SIDED|95.0|0.33|1.43|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 14||1.43|0.33|
73985567|NCT04341584|147516493|SUPERIORITY||Median posterior OR|0.7|||||TWO_SIDED|95.0|0.35|1.38|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 28||1.38|0.35|
73985568|NCT04341584|147516493|SUPERIORITY||Median posterior OR|0.72|||||TWO_SIDED|95.0|0.22|2.39|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence Interval is % Credible interval here|Day 4||2.39|0.22|
73985569|NCT04341584|147516493|SUPERIORITY||Median posterior HR|0.89|||||TWO_SIDED|95.0|0.28|2.8|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence Interval is % Credible interval here|Day 7||2.80|0.28|
73985570|NCT04341584|147516493|SUPERIORITY||Median posterior HR|0.57|||||TWO_SIDED|95.0|0.18|1.75||Day 14|Bayesian Proportionnal odds model|Adjusted for afe and centre|% Confidence Interval is % Credible interval here|||1.75|0.18|
73985571|NCT04341584|147516494|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.23|1.29|||Regression, Cox|adjusted for age and centre||14 days||1.29|0.23|
73985572|NCT04341584|147516494|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.33|1.77|||Regression, Cox|Adjusted for age and centre||28 days||1.77|0.33|
73985573|NCT04341584|147516494|SUPERIORITY|90 days|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.46|2.04|||Regression, Cox|adjusted on age and centre|% Confidence interval is % Credible interval here|||2.04|0.46|
73985574|NCT04341584|147516494|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.11|3.86|||Regression, Cox|adjusted on age and centre||||3.86|0.11|
74034323|NCT06704178|147621486|SUPERIORITY|||||||0.952378||||||Comparison at Month 5|t-test, 2 sided|||||||0.952378
74034324|NCT06704178|147621486|SUPERIORITY|||||||0.998846||||||Comparison at Month 6|t-test, 2 sided|||||||0.998846
74034325|NCT06704178|147621487|SUPERIORITY|||||||0.55783||||||Comparison at Month 1|t-test, 2 sided|||||||0.55783
74034326|NCT06704178|147621487|SUPERIORITY|||||||0.987949||||||Comparison at Month 2|t-test, 2 sided|||||||0.987949
74034327|NCT06704178|147621487|SUPERIORITY|||||||0.576782||||||Comparison at Month 3|t-test, 2 sided|||||||0.576782
74034328|NCT06704178|147621487|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
74034329|NCT06704178|147621487|SUPERIORITY|||||||0.989226||||||Comparison at Month 5|t-test, 2 sided|||||||0.989226
74034330|NCT06704178|147621487|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
74034331|NCT06704178|147621488|SUPERIORITY|||||||0.795476||||||Comparison at Month 1|t-test, 2 sided|||||||0.795476
74034332|NCT06704178|147621488|SUPERIORITY|||||||0.977286||||||Comparison at Month 2|t-test, 2 sided|||||||0.977286
74034333|NCT06704178|147621488|SUPERIORITY|||||||0.559556||||||Comparison at Month 3|t-test, 2 sided|||||||0.559556
74034334|NCT06704178|147621488|SUPERIORITY|||||||0.997753||||||Comparison at Month 4|t-test, 2 sided|||||||0.997753
74034335|NCT06704178|147621488|SUPERIORITY|||||||0.952378||||||Comparison at Month 5|t-test, 2 sided|||||||0.952378
74034336|NCT06704178|147621488|SUPERIORITY|||||||0.988108||||||Comparison at Month 6|t-test, 2 sided|||||||0.988108
74034337|NCT06704178|147621489|SUPERIORITY|||||||0.995367||||||Comparison at Month 1|t-test, 2 sided|||||||0.995367
74034338|NCT06704178|147621489|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
74034339|NCT06704178|147621489|SUPERIORITY|||||||0.974102||||||Comparison at Month 3|t-test, 2 sided|||||||0.974102
73875050|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.8729|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Plasmablasts||||0.8729
73985575|NCT04341584|147516494|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.19|4.68|||Regression, Cox|adjusted on age and centre||||4.68|0.19|
73985576|NCT04341584|147516494|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.31|4.87|||Regression, Cox|adjusted on age and centre||||4.87|0.31|
73985577|NCT04341584|147516495|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-8.3|6.4||||adjusted on age and centre||||6.4|-8.3|
73985578|NCT04341584|147516497|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.64|1.61|||Fine-Gray model|Adjusted for age and centre||||1.61|0.64|
73985579|NCT04341584|147516497|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.58|3.07||Adjusted for age and centre|Fine-Gray model|Adjusted for age and centre||||3.07|0.58|
73985580|NCT04341584|147516498|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.56|1.48|||Fine-Gray model|adjusted on age and centre||||1.48|0.56|
73985581|NCT04341584|147516498|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.35|2.34||adjusted on age and centre|Fine-Gray model|||||2.34|0.35|
73985582|NCT04341584|147516499|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.43|2.32||adjusted on age and centre|Fine-Gray model|||Day 28||2.32|0.43|
73985583|NCT04341584|147516499|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.52|2.29||adjusted on age and centre|Fine-Gray model|||Day 90||2.29|0.52|
73985584|NCT02799745|147516523|SUPERIORITY||Hazard Ratio (HR)|0.542||||0.016|TWO_SIDED|95.0|0.33|0.892||P-value was from a 2-sided stratified log-rank test.|Log Rank||HR, 95% CI for HR:based on a Cox regression model assuming proportional hazards with treatment, prostate cancer risk,type of biopsy,baseline variables(as age, race), time since prostate cancer diagnosis as fixed effects and random effect of site.|||0.892|0.330|0.016
73985585|NCT02799745|147516525|SUPERIORITY||Odds Ratio (OR)|3.5||||0|TWO_SIDED|95.0|1.76|6.92||P-value: Based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where fixed covariates=treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis; random effects: site and subject. 95% CI: based on exact binomial distribution.|At the end of month 12||6.92|1.76|0.00
73985586|NCT02799745|147516525|SUPERIORITY||Odds Ratio (OR)|1.6||||0.289|TWO_SIDED|95.0|0.66|4.0||P-value: Based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where fixed covariates=treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis; random effects: site and subject. 95% CI: based on exact binomial distribution.|At the end of month 24||4.00|0.66|0.289
73985587|NCT02799745|147516526|SUPERIORITY||LS mean difference|-10.07|STANDARD_ERROR_OF_MEAN|2.398|<|0.001|TWO_SIDED|95.0|-14.79|-5.34||P-values: from differences of least squares means.Bonferroni-Holm was used in the primary hypothesis testing to adjust for multiplicity.|Mixed Models Analysis|Compound symmetry was used as the covariance structure. Covariance parameters:estimated using Restricted Maximum likelihood.|Mixed model repeated measure(MMRM) with treatment group, prostate cancer risk(low/intermediate), type of biopsy(mpMRI-targeted/non-mpMRI-targeted), visit, visit-by-treatment, baseline scores as fixed factors, site and participants as random factors.|Change at month 12||-5.34|-14.79|<0.001
73985588|NCT02799745|147516526|SUPERIORITY||LS mean difference|-5.15|STANDARD_ERROR_OF_MEAN|3.174||0.1063|TWO_SIDED|95.0|-11.4|1.11||P-values: from differences of least squares means.Bonferroni-Holm was used in the primary hypothesis testing to adjust for multiplicity.|Mixed Models Analysis|Compound symmetry was used as the covariance structure. Covariance parameters:estimated using Restricted Maximum likelihood.|MMRM with treatment group, prostate cancer risk (low vs. intermediate), type of biopsy (mpMRI targeted vs. non mpMRI targeted), visit, visit-by-treatment and baseline scores were the fixed factors, and site and participants were the random factors.|Change at month 24||1.11|-11.40|0.1063
73985589|NCT02799745|147516527|SUPERIORITY||Hazard Ratio (HR)|0.714||||0.032|TWO_SIDED|95.0|0.525|0.972||P-value: from a 2-sided, stratified log-rank test.|Log Rank||HR and 95% CI for HR:based on Cox regression model assuming proportional hazards with treatment, prostate cancer risk, type of biopsy, baseline variables(as age, race), time since prostate cancer diagnosis as fixed effects and random effect of site.|||0.972|0.525|0.032
73985590|NCT02799745|147516528|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.08|0.26||P-value:based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR:from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of month 12||0.26|0.08|0.000
73985591|NCT02799745|147516528|SUPERIORITY||Odds Ratio (OR)|1.1||||0.807|TWO_SIDED|95.0|0.37|3.53||P-value: based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of month 24||3.53|0.37|0.807
73985592|NCT02799745|147516528|SUPERIORITY||Odds Ratio (OR)|1.0||||0.931|TWO_SIDED|95.0|0.5|2.15||P-value:based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of study||2.15|0.50|0.931
73985593|NCT02924350|147516590|OTHER||Least square (LS) mean difference|-0.924|||<|0.0001|TWO_SIDED|95.0|-1.0547|-0.7927|||ANCOVA|ANCOVA: change from baseline in Schiff sensitivity score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.|||-0.7927|-1.0547|<.0001
73875051|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.7261|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Naive B-cell compartment||||0.7261
73985594|NCT00097708|147516593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.654|TWO_SIDED|95.0|-2.2|1.4|||ANCOVA|||||1.4|-2.2|0.6540
73985595|NCT00097708|147516593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2||||0.0005|TWO_SIDED|95.0|-5.0|-1.4|||ANCOVA|||||-1.4|-5.0|0.0005
74034340|NCT06704178|147621489|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
74034341|NCT06704178|147621489|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
74034342|NCT06704178|147621489|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
73985596|NCT00097708|147516593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.0015|TWO_SIDED|95.0|1.1|4.5|||ANCOVA|||||4.5|1.1|0.0015
74034343|NCT06704178|147621490|SUPERIORITY|||||||0.882016||||||Comparison at Month 1|t-test, 2 sided|||||||0.882016
74034344|NCT06704178|147621490|SUPERIORITY|||||||0.860406||||||Comparison at Month 2|t-test, 2 sided|||||||0.860406
73985597|NCT01589523|147516608|EQUIVALENCE|paired t-test||||||0.342|||||||t-test, 2 sided|||||||0.342
73985598|NCT01589523|147516609|EQUIVALENCE|paired t-test||||||0.116|||||||t-test, 2 sided|||||||0.116
73985599|NCT01589523|147516610|EQUIVALENCE|paired t-test||||||0.065|||||||t-test, 2 sided|vitamin D||||||0.065
74034345|NCT06704178|147621490|SUPERIORITY|||||||0.958944||||||Comparison at Month 3|t-test, 2 sided|||||||0.958944
73875052|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.9338|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Transitional B-cells||||0.9338
74034346|NCT06704178|147621490|SUPERIORITY|||||||0.998816||||||Comparison at Month 4|t-test, 2 sided|||||||0.998816
74034347|NCT06704178|147621490|SUPERIORITY|||||||0.989226||||||Comparison at Month 5|t-test, 2 sided|||||||0.989226
74034348|NCT06704178|147621490|SUPERIORITY|||||||0.999296||||||Comparison at Month 6|t-test, 2 sided|||||||0.999296
74034349|NCT06704178|147621491|SUPERIORITY|||||||0.999975||||||Comparison at Month 1.|t-test, 2 sided|||||||0.999975
73985600|NCT02983877|147516619|SUPERIORITY||||||<|0.001|||||||Friedman test|3 degrees of freedom||||||<0.001
73985601|NCT02983877|147516620|SUPERIORITY||||||<|0.001|||||||ANOVA|3 degrees of freedom||||||<0.001
73985602|NCT02983877|147516621|SUPERIORITY||||||<|0.001|||||||Friedman test|3 degrees of freedom||||||<0.001
74034350|NCT06704178|147621491|SUPERIORITY|||||||0.977286||||||Comparison at Month 2|t-test, 2 sided|||||||0.977286
74034351|NCT06704178|147621491|SUPERIORITY|||||||0.999||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999
74034352|NCT06704178|147621491|SUPERIORITY|||||||0.999984||||||Comparison at Month 4.|t-test, 2 sided|||||||0.999984
74034353|NCT06704178|147621491|SUPERIORITY|||||||0.986557||||||Comparison at Month 5.|t-test, 2 sided|||||||0.986557
74034354|NCT06704178|147621491|SUPERIORITY|||||||0.998367||||||Comparison at Month 6.|t-test, 2 sided|||||||0.998367
74034355|NCT06704178|147621492|SUPERIORITY|||||||0.999851||||||Comparison at Month 1.|t-test, 2 sided|||||||0.999851
74034356|NCT06704178|147621492|SUPERIORITY|||||||0.999779||||||Comparison at Month 2.|t-test, 2 sided|||||||0.999779
73875053|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.9074|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Naive B-cells||||0.9074
73875054|NCT01332994|147291737|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Memory B-cells||||<0.0001
73985603|NCT02983877|147516622|SUPERIORITY|||||||0.89|||||||ANOVA|2 degrees of freedom||||||0.89
73985604|NCT03721978|147516623|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in Percentage|28.6||||0.115|TWO_SIDED|95.0|-24.6|50.4|||Miettinen and Nurminen method|||||50.4|-24.6|0.115
73985605|NCT03721978|147516628|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in Percentage|18.9||||0.001|TWO_SIDED|95.0|7.8|28.6|||Miettinen and Nurminen method|||||28.6|7.8|0.001
73985606|NCT03721978|147516629|OTHER||Difference in Percentage|13.1|||||TWO_SIDED|95.0|-37.7|46.0||||||||46.0|-37.7|
73985607|NCT03721978|147516630|OTHER||Difference in Percentage|12.6|||||TWO_SIDED|95.0|-0.8|24.5||||||||24.5|-0.8|
73985608|NCT03721978|147516631|OTHER||Difference in Percentage|38.1|||||TWO_SIDED|95.0|-15.7|59.5||||||||59.5|-15.7|
73985609|NCT03721978|147516632|OTHER||Difference in Percentage|27.9|||||TWO_SIDED|95.0|16.0|38.2||||||||38.2|16.0|
73985610|NCT03721978|147516633|OTHER||Difference in Percentage|13.1|||||TWO_SIDED|95.0|-37.7|46.0||||||||46.0|-37.7|
73985611|NCT03721978|147516634|OTHER||Difference in Percentage|17.6|||||TWO_SIDED|95.0|5.2|28.5||||||||28.5|5.2|
74034357|NCT06704178|147621492|SUPERIORITY|||||||0.999801||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999801
74034358|NCT06704178|147621492|SUPERIORITY|||||||0.998467||||||Comparison at Month 4.|t-test, 2 sided|||||||0.998467
74034359|NCT06704178|147621492|SUPERIORITY|||||||0.999816||||||Comparison at Month 5.|t-test, 2 sided|||||||0.999816
74034360|NCT06704178|147621492|SUPERIORITY|||||||0.998846||||||Comparison at Month 6.|t-test, 2 sided|||||||0.998846
74034361|NCT06704178|147621493|SUPERIORITY||||||>|0.999999||||||Comparison at Month 1.|t-test, 2 sided|||||||>0.999999
74034362|NCT06704178|147621493|SUPERIORITY|||||||0.999779||||||Comparison at Month 2.|t-test, 2 sided|||||||0.999779
74034363|NCT06704178|147621493|SUPERIORITY|||||||0.999801||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999801
74034364|NCT06704178|147621493|SUPERIORITY|||||||0.963236||||||Comparison at Month 4.|t-test, 2 sided|||||||0.963236
74034365|NCT06704178|147621493|SUPERIORITY|||||||0.999816||||||Comparison at Month 5.|t-test, 2 sided|||||||0.999816
74034366|NCT06704178|147621493|SUPERIORITY|||||||0.737995||||||Comparison at Month 6.|t-test, 2 sided|||||||0.737995
74034367|NCT06704178|147621494|SUPERIORITY|||||||0.0003||||||Within-group analysis only.|t-test, 2 sided|||||||0.0003
74034368|NCT06704178|147621495|SUPERIORITY|||||||0.2698||||||Within-group analysis only.|t-test, 2 sided|||||||0.2698
74034369|NCT06704178|147621496|SUPERIORITY|||||||0.2698||||||Within-group analysis only.|t-test, 2 sided|||||||0.2698
74034370|NCT06704178|147621497|SUPERIORITY|||||||0.2137||||||Within-group analysis only.|t-test, 2 sided|||||||0.2137
74034371|NCT06704178|147621498|SUPERIORITY|||||||0.8639||||||Within-group analysis only.|t-test, 2 sided|||||||0.8639
74034372|NCT06704178|147621499|SUPERIORITY|||||||0.239||||||Within-group analysis only.|t-test, 2 sided|||||||0.239
74034373|NCT06704178|147621500|SUPERIORITY|||||||0.6088||||||Within-group analysis only.|t-test, 2 sided|||||||0.6088
74034374|NCT06704178|147621501|SUPERIORITY|||||||0.5738||||||Within-group analysis only.|t-test, 2 sided|||||||0.5738
73875055|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.9338|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Pre-switch memory B-cells||||0.9338
73985612|NCT03721978|147516635|OTHER||Difference in Percentage|28.6|||||TWO_SIDED|95.0|-24.6|50.4||||||||50.4|-24.6|
73985613|NCT03721978|147516636|OTHER||Difference in Percentage|20.3|||||TWO_SIDED|95.0|10.1|29.5||||||||29.5|10.1|
73985614|NCT03721978|147516637|OTHER||Difference in Percentage|1.2|||||TWO_SIDED|95.0|-31.2|50.5||||||||50.5|-31.2|
73985615|NCT03721978|147516638|OTHER||Difference in Percentage|5.3|||||TWO_SIDED|95.0|-6.0|17.9||||||||17.9|-6.0|
73985616|NCT03721978|147516639|OTHER||Difference in Percentage|-6.0|||||TWO_SIDED|95.0|-54.7|25.8||||||||25.8|-54.7|
73985617|NCT03721978|147516640|OTHER||Difference in Percentage|12.2|||||TWO_SIDED|95.0|1.1|21.9||||||||21.9|1.1|
73985618|NCT03721978|147516641|OTHER||Location Shift|449.0|||||TWO_SIDED|95.0|0.0|18224.0||||||Week 15: HPV-16 E7||18224.0|0.0|
73985619|NCT03721978|147516641|OTHER||Location Shift|0.0|||||TWO_SIDED|95.0|-18224.0|674.0||||||Week 36: HPV-16 E7||674.0|-18224.0|
73985620|NCT03721978|147516641|OTHER||Location Shift|4049.0|||||TWO_SIDED|95.0|224.0|18224.0||||||Week 15: HPV-18 E7||18224.0|224.0|
73985621|NCT03721978|147516641|OTHER||Location Shift|74.0|||||TWO_SIDED|95.0|-18000.0|6074.0||||||Week 36: HPV-18 E7||6074.0|-18000.0|
73985622|NCT03721978|147516642|OTHER||Location Shift|224.0|||||TWO_SIDED|95.0|224.0|674.0||||||Week 15: HPV-16 E7||674.0|224.0|
73985623|NCT03721978|147516642|OTHER||Location Shift|0.0|||||TWO_SIDED|95.0|0.0|24.0||||||Week 36: HPV-16 E7||24.0|0.0|
74034375|NCT06704178|147621502|SUPERIORITY|||||||0.6088||||||Within-group analysis only.|t-test, 2 sided|||||||0.6088
74034376|NCT06704178|147621503|SUPERIORITY|||||||0.4942||||||Within-group analysis only.|t-test, 2 sided|||||||0.4942
74034377|NCT06704178|147621504|SUPERIORITY|||||||0.7419||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7419
73985624|NCT03721978|147516642|OTHER||Location Shift|2024.0|||||TWO_SIDED|95.0|2024.0|6074.0||||||Week 15: HPV-18 E7||6074.0|2024.0|
73985625|NCT03721978|147516642|OTHER||Location Shift|674.0|||||TWO_SIDED|95.0|224.0|674.0||||||Week 36: HPV-18 E7||674.0|224.0|
73985626|NCT03721978|147516643|OTHER||Location Shift|25.0|||||TWO_SIDED|95.0|0.0|73.33||||||HPV-16 E6: Week 15||73.33|0.00|
73985627|NCT03721978|147516643|OTHER||Location Shift|15.0|||||TWO_SIDED|95.0|0.0|38.33||||||HPV-16 E6: Week 36||38.33|0.00|
73985628|NCT03721978|147516643|OTHER||Location Shift|16.67|||||TWO_SIDED|95.0|0.0|85.0||||||HPV-16 E7: Week 15||85.00|0.00|
73985629|NCT03721978|147516643|OTHER||Location Shift|5.0|||||TWO_SIDED|95.0|0.0|36.67||||||HPV-16 E7: Week 36||36.67|0.00|
73985630|NCT03721978|147516643|OTHER||Location Shift|26.67|||||TWO_SIDED|95.0|0.0|181.67||||||HPV-18 E6: Week 15||181.67|0.00|
73985631|NCT03721978|147516643|OTHER||Location Shift|11.67|||||TWO_SIDED|95.0|0.0|31.67||||||HPV-18 E6: Week 36||31.67|0.00|
73985632|NCT03721978|147516643|OTHER||Location Shift|3.33|||||TWO_SIDED|95.0|0.0|46.67||||||HPV-18 E7: Week 15||46.67|0.00|
73985633|NCT03721978|147516643|OTHER||Location Shift|4.17|||||TWO_SIDED|95.0|0.0|20.0||||||HPV-18 E7: Week 36||20.00|0.00|
73985634|NCT03721978|147516644|OTHER||Location Shift|8.33|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 15||11.67|3.33|
73985635|NCT03721978|147516644|OTHER||Location Shift|5.83|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 36||11.67|3.33|
73985636|NCT03721978|147516644|OTHER||Location Shift|5.0|||||TWO_SIDED|95.0|1.67|11.67||||||HPV-16 E7: Week 15||11.67|1.67|
73985637|NCT03721978|147516644|OTHER||Location Shift|1.67|||||TWO_SIDED|95.0|0.0|5.0||||||HPV-16 E7: Week 36||5.00|0.00|
73985638|NCT03721978|147516644|OTHER||Location Shift|25.0|||||TWO_SIDED|95.0|15.0|40.0||||||HPV-18 E6: Week 15||40.00|15.00|
73985639|NCT03721978|147516644|OTHER||Location Shift|16.67|||||TWO_SIDED|95.0|10.0|28.33||||||HPV-18 E6: Week 36||28.33|10.00|
73985640|NCT03721978|147516644|OTHER||Location Shift|3.33|||||TWO_SIDED|95.0|1.67|6.67||||||HPV-18 E7: Week 15||6.67|1.67|
73985641|NCT03721978|147516644|OTHER||Location Shift|1.67|||||TWO_SIDED|95.0|0.0|3.33||||||HPV-18 E7: Week 36||3.33|0.00|
73985642|NCT03721978|147516645|OTHER||Location Shift|0.033|||||TWO_SIDED|95.0|-0.004|0.325||||||Parameter: CD8+CD137+Perforin+||0.325|-0.004|
74034378|NCT06704178|147621504|SUPERIORITY|||||||0.0033||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0033
74034379|NCT06704178|147621504|SUPERIORITY|||||||0.0219||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
73985643|NCT03721978|147516645|OTHER||Location Shift|0.005|||||TWO_SIDED|95.0|0.0|0.208||||||Parameter: CD8+CD38+Perforin+||0.208|0.000|
73985644|NCT03721978|147516645|OTHER||Location Shift|0.014|||||TWO_SIDED|95.0|-0.055|0.31||||||Parameter: CD8+CD69+Perforin+||0.310|-0.055|
73985645|NCT03721978|147516646|OTHER||Location Shift|0.041|||||TWO_SIDED|95.0|0.004|0.077||||||Parameter: CD8+CD137+Perforin+||0.077|0.004|
73985646|NCT03721978|147516646|OTHER||Location Shift|0.011|||||TWO_SIDED|95.0|0.003|0.028||||||Parameter: CD8+CD38+Perforin+||0.028|0.003|
73985647|NCT03721978|147516646|OTHER||Location Shift|0.034|||||TWO_SIDED|95.0|0.022|0.053||||||Parameter: CD8+CD69+Perforin+||0.053|0.022|
73985648|NCT05244226|147516649|SUPERIORITY|||||||0.045|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.045
73985649|NCT05244226|147516649|SUPERIORITY|||||||0.023|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.023
73985650|NCT05244226|147516653|SUPERIORITY|||||||0.144|||||||Kruskal-Wallis|||||||0.144
73985651|NCT05244226|147516653|SUPERIORITY|||||||0.322|||||||Kruskal-Wallis|||||||0.322
73985652|NCT05244226|147516654|SUPERIORITY|||||||0.061|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.061
73985653|NCT05244226|147516654|SUPERIORITY|||||||0.021|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.021
73985654|NCT02675998|147516665|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
73985655|NCT02675998|147516666|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73985656|NCT02675998|147516666|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73985657|NCT02675998|147516666|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73985658|NCT00275301|147516667|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||Examination of relationship between Borderline Personality Disorder symptoms and brain metabolism at baseline.||||<0.05
74034380|NCT06704178|147621505|SUPERIORITY|||||||0.7708||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7708
74034381|NCT06704178|147621505|SUPERIORITY|||||||0.239||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.239
73985659|NCT04357964|147516668|EQUIVALENCE|Statistical significance was defined as p\< 0.05 for determining difference between groups at baseline in this observational study. There was no treatment intervention in this study, so there is no true equivalence margin.|||||<|0.01||||||Statistical significance was defined as p\< 0.05|Kruskal-Wallis|||||||<0.01
74089707|NCT03545191|147732306|OTHER||LS mean difference to placebo|9.93|||=|0.0334|TWO_SIDED|95.0|0.782|19.082||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 25 mg vs placebo).||19.082|0.782|= 0.0334
73985660|NCT04357964|147516669|EQUIVALENCE|Statistical significance was defined as p \< 0.05. There was no intervention in this study, so there is no true equivalence margin.|||||<|0.01|||||||Pearson correlation|||||||<0.01
73985661|NCT04357964|147516670|EQUIVALENCE|Statistical significance was defined as p\< 0.05 for determining difference between groups in this observational study. There was no treatment intervention in this study, so there is no true equivalence margin.||||||0.52||||||Statistical significance was defined as p\< 0.05|Kruskal-Wallis|||||||0.52
73985662|NCT02097849|147516671|SUPERIORITY_OR_OTHER||Difference in proportion|-0.04||||0.692|TWO_SIDED|95.0|-0.27|0.19|||Clopper-Pearson Exact|||||0.19|-0.27|0.692
73985663|NCT02097849|147516672|SUPERIORITY_OR_OTHER||Difference in proportion|-0.19||||0.12|TWO_SIDED|95.0|-0.41|0.05|||Clopper-Pearson Exact|||Responders at Day 28||0.05|-0.41|0.120
73985664|NCT02097849|147516673|SUPERIORITY_OR_OTHER||Difference in proportions|-0.13||||0.225|TWO_SIDED|95.0|-0.35|0.1|||Clopper-Pearson Exact|||||0.10|-0.35|0.225
73985665|NCT02097849|147516674|SUPERIORITY_OR_OTHER||Difference in proportions|-0.22||||0.057|TWO_SIDED|95.0|-0.44|0.01|||Clopper-Pearson Exact|||||0.01|-0.44|0.057
73985666|NCT02097849|147516675|SUPERIORITY_OR_OTHER||Difference in proportions|0.07||||0.3|TWO_SIDED|95.0|-0.16|0.3|||Clopper-Pearson Exact|||||0.30|-0.16|0.300
73985667|NCT02097849|147516676|SUPERIORITY_OR_OTHER||Difference in proportions|-0.03||||0.714|TWO_SIDED|95.0|-0.26|0.2|||Clopper-Pearson Exact|||||0.20|-0.26|0.714
73985668|NCT02097849|147516677|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||0.967|TWO_SIDED|95.0|-0.24|0.23|||Clopper-Pearson Exact|||||0.23|-0.24|0.967
73985669|NCT02097849|147516678|SUPERIORITY_OR_OTHER||Difference in proportions|-0.01||||0.955|TWO_SIDED|95.0|-0.24|0.22|||Clopper-Pearson Exact|||||0.22|-0.24|0.955
73985670|NCT00733226|147516687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.52||0.05|TWO_SIDED|95.0|-3.2|-1.1||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The sample size was computed to prove that a 30% decrease of the rate of virus provoked wheezing attacks in the OM-85 group compared with placebo is statistically significant. Approximately 29 analyzable participants in each group were required, with α=0.05 and β=0.10 (ie, with a power of 90%), respectively. The difference of 30% was taken from both pilot study and clinical experience. Sample size estimation was performed by using NCSS and PASS 2000 software.||-1.10|-3.20|0.05
73985671|NCT00733226|147516688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-3.06|-1.01||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||-1.01|-3.06|<0.001
73985672|NCT00733226|147516689|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.94|-1.27|||Wilcoxon (Mann-Whitney)|P value was not need to adjusted for multiple comparisons||||-1.27|-2.94|<0.001
73985673|NCT00733226|147516690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.22||0.11|TWO_SIDED|95.0|-0.77|0.11||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.11|-0.77|0.110
73985674|NCT00733226|147516691|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.14||0.195|TWO_SIDED|95.0|-0.55|0.03||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.03|-0.55|0.195
73985675|NCT00733226|147516692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.82||0.452|TWO_SIDED|95.0|-2.87|0.42||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.42|-2.87|0.452
73985676|NCT01540162|147516694|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.23||||0.05|TWO_SIDED|95.0|0.05|0.73|||Chi-squared|||||0.73|0.05|0.05
73985677|NCT02561078|147516707|NON_INFERIORITY|The test for the primary objective of noninferiority was performed at the 0.05 significance level using the LS Mean estimate of the difference in change in HbA1c between the 2 treatments at Week 26. Noninferiority was established if the upper limit of a 2-sided 95% confidence interval (CI) for the difference (U 500R CSII minus U 500R MDI) was below the noninferiority margin (NIM) of 0.4%.|Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.62|-0.22|||Mixed Models Analysis|||||-0.22|-0.62|<0.001
73985678|NCT02561078|147516708|SUPERIORITY||Mean Difference (Net)|-35.6|||<|0.001|TWO_SIDED|95.0|-49.4|-21.7|||Mixed Models Analysis|||||-21.7|-49.4|<0.001
73985679|NCT02561078|147516709|SUPERIORITY||Odds Ratio (OR)|1.97||||0.015|TWO_SIDED|95.0|1.14|3.39|||Regression, Logistic|||||3.39|1.14|0.015
73985680|NCT02561078|147516710|SUPERIORITY||Odds Ratio (OR)|1.94||||0.005|TWO_SIDED|95.0|1.23|3.07|||Regression, Logistic|||||3.07|1.23|0.005
73985681|NCT02561078|147516711|SUPERIORITY||Mean Difference (Net)|-22.5|||<|0.001|TWO_SIDED|95.0|-32.1|-12.8|||Mixed Models Analysis|||Pre Morning Meal||-12.8|-32.1|<0.001
73985682|NCT02561078|147516711|SUPERIORITY||Mean Difference (Net)|-17.2||||0.008|TWO_SIDED|95.0|-29.9|-4.6|||Mixed Models Analysis|||2 Hours Post Morning Meal||-4.6|-29.9|0.008
73985683|NCT02561078|147516711|SUPERIORITY||Mean Difference (Net)|-8.9||||0.138|TWO_SIDED|95.0|-20.6|2.9|||Mixed Models Analysis|||Pre Mid-Day Meal||2.9|-20.6|0.138
73985684|NCT02561078|147516711|SUPERIORITY||Mean Difference (Net)|8.3||||0.16|TWO_SIDED|95.0|-3.3|19.8|||Mixed Models Analysis|||2 Hours Post Mid-Day Meal||19.8|-3.3|0.160
73985685|NCT02561078|147516711|SUPERIORITY||Mean Difference (Net)|9.1||||0.113|TWO_SIDED|95.0|-2.2|20.4|||Mixed Models Analysis|||Pre Evening Meal||20.4|-2.2|0.113
73985686|NCT02561078|147516711|SUPERIORITY||Mean Difference (Net)|16.7||||0.004|TWO_SIDED|95.0|5.3|28.2|||Mixed Models Analysis|||2 Hours Post Evening Meal||28.2|5.3|0.004
73985687|NCT02561078|147516711|SUPERIORITY||Mean Difference (Net)|0.6||||0.905|TWO_SIDED|95.0|-9.5|10.8|||Mixed Models Analysis|||Overnight (3:00 AM)||10.8|-9.5|0.905
74089708|NCT03545191|147732306|OTHER||LS mean difference to placebo|19.77|||<|1e-05|TWO_SIDED|95.0|10.623|28.918||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 50 mg vs placebo).||28.918|10.623|< .00001
73985688|NCT02561078|147516712|SUPERIORITY||Mean Difference (Net)|-48.4|||<|0.001|TWO_SIDED|95.0|-74.1|-22.8|||Mixed Models Analysis|||||-22.8|-74.1|<0.001
73985689|NCT02561078|147516713|SUPERIORITY||Odds Ratio (OR)|1.05||||0.919|TWO_SIDED|95.0|0.39|2.86|||Regression, Logistic|||||2.86|0.39|0.919
73985690|NCT02561078|147516714|SUPERIORITY||Relative Rate|1.21||||0.025|TWO_SIDED|95.0|1.02|1.42|||Negative binomial regression|||||1.42|1.02|0.025
73985691|NCT02561078|147516715|SUPERIORITY||Mean Difference (Net)|0.8||||0.1|TWO_SIDED|95.0|-0.2|1.8|||Mixed Models Analysis|||||1.8|-0.2|0.100
73985692|NCT02288364|147516719|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Chi-squared|||||||0.30
73985693|NCT02288364|147516720|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Chi-squared|||||||0.08
73985694|NCT02288364|147516721|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Chi-squared|||||||0.29
73985695|NCT00043186|147516728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.87|||<|0.001||95.0|4.59|7.16|||ANCOVA|||||7.16|4.59|<0.001
73985696|NCT00043186|147516728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|||<|0.001||95.0|5.01|7.65|||ANCOVA|||||7.65|5.01|<0.001
73985697|NCT00043186|147516728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35|||<|0.001||95.0|4.07|6.64|||ANCOVA|||||6.64|4.07|<0.001
73985698|NCT00043186|147516728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|||<|0.001||95.0|2.6|5.07|||ANCOVA|||||5.07|2.60|<0.001
73985699|NCT00043186|147516728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||<|0.001||95.0|6.13|8.87|||ANCOVA|||||8.87|6.13|<0.001
73985700|NCT00043186|147516728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.52|||<|0.001||95.0|4.19|6.85|||ANCOVA|||||6.85|4.19|<0.001
73985701|NCT00043186|147516728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||<|0.001||95.0|3.88|6.55|||ANCOVA|||||6.55|3.88|<0.001
73985702|NCT00043186|147516729|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985703|NCT00043186|147516729|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74089709|NCT03545191|147732307|OTHER||LS mean difference to placebo|-0.75|||=|0.0547|TWO_SIDED|95.0|-1.515|0.015||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 25 mg vs placebo).||0.015|-1.515|= 0.0547
73985704|NCT00043186|147516729|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985705|NCT00043186|147516729|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985706|NCT00043186|147516729|SUPERIORITY_OR_OTHER|||||||0.166|||||||Wilcoxon (Mann-Whitney)|||||||0.166
73985707|NCT00043186|147516729|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985708|NCT00043186|147516729|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985709|NCT00043186|147516729|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985710|NCT00043186|147516730|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985711|NCT00043186|147516730|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985712|NCT00043186|147516730|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985713|NCT00043186|147516730|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985714|NCT00043186|147516730|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985715|NCT00043186|147516730|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985716|NCT00043186|147516730|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
73985717|NCT00043186|147516730|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985718|NCT00043186|147516732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.34|||<|0.001||95.0|5.56|9.12|||ANCOVA|||||9.12|5.56|<0.001
73985719|NCT00043186|147516732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.11|||<|0.001||95.0|7.31|10.91|||ANCOVA|||||10.91|7.31|<0.001
73985720|NCT00043186|147516732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.56|||<|0.001||95.0|6.71|10.41|||ANCOVA|||||10.41|6.71|<0.001
73985721|NCT00043186|147516732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.44|||<|0.001||95.0|6.69|10.19|||ANCOVA|||||10.19|6.69|<0.001
73985722|NCT00043186|147516732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19|||<|0.001||95.0|3.43|6.94|||ANCOVA|||||6.94|3.43|<0.001
73985723|NCT00043186|147516732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.08|||<|0.001||95.0|8.14|12.01|||ANCOVA|||||12.01|8.14|<0.001
73985724|NCT00043186|147516732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.46|||<|0.001||95.0|6.62|10.3|||ANCOVA|||||10.30|6.62|<0.001
73985725|NCT00043186|147516732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.66|||<|0.001||95.0|6.8|10.53|||ANCOVA|||||10.53|6.80|<0.001
73985726|NCT00043186|147516733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||<|0.001||95.0|4.32|8.67|||ANCOVA|||||8.67|4.32|<0.001
73985727|NCT00043186|147516733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65||||0.013||95.0|0.55|4.75|||ANCOVA|||||4.75|0.55|0.013
73985728|NCT00043186|147516733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.43|||<|0.001||95.0|10.19|14.68|||ANCOVA|||||14.68|10.19|<0.001
73985729|NCT00043186|147516733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.84|||<|0.001||95.0|8.74|12.94|||ANCOVA|||||12.94|8.74|<0.001
73985730|NCT00043186|147516733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.79|||<|0.001||95.0|7.69|11.89|||ANCOVA|||||11.89|7.69|<0.001
73985731|NCT00043186|147516733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.37|6.12|||ANCOVA|||||6.12|1.37|<0.001
73985732|NCT00043186|147516733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.97|||<|0.001||95.0|8.63|13.32|||ANCOVA|||||13.32|8.63|<0.001
73985733|NCT00043186|147516733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.37|||<|0.001||95.0|8.16|12.59|||ANCOVA|||||12.59|8.16|<0.001
73985734|NCT00043186|147516734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42||||0.02||95.0|0.89|9.95|||ANCOVA|||||9.95|0.89|0.02
73985735|NCT00043186|147516734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.992||95.0|-5.07|5.02|||ANCOVA|||||5.02|-5.07|0.992
73985736|NCT00043186|147516734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9||||0.004||95.0|3.72|14.09|||ANCOVA|||||14.09|3.72|0.004
73985737|NCT00043186|147516734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5||||0.001||95.0|4.15|12.86|||ANCOVA|||||12.86|4.15|0.001
73985738|NCT00043186|147516734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.37||||0.001||95.0|4.11|12.63|||ANCOVA|||||12.63|4.11|0.001
73985739|NCT00043186|147516734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98||||0.292||95.0|-1.42|9.37|||ANCOVA|||||9.37|-1.42|0.292
73985740|NCT00043186|147516734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.95||||0.004||95.0|3.94|13.96|||ANCOVA|||||13.96|3.94|0.004
73985741|NCT00043186|147516734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.12||||0.094||95.0|0.57|11.67|||ANCOVA|||||11.67|0.57|0.094
73985742|NCT00043186|147516735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.93|||<|0.001||95.0|3.97|9.89|||ANCOVA|||||9.89|3.97|<0.001
73985743|NCT00043186|147516735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.89|||<|0.001||95.0|1.92|7.85|||ANCOVA|||||7.85|1.92|<0.001
73985744|NCT00043186|147516735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.15|||<|0.001||95.0|11.08|17.21|||ANCOVA|||||17.21|11.08|<0.001
73985745|NCT00043186|147516735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.73|||<|0.001||95.0|9.94|15.52|||ANCOVA|||||15.52|9.94|<0.001
73985746|NCT00043186|147516735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.49|||<|0.001||95.0|9.66|15.32|||ANCOVA|||||15.32|9.66|<0.001
73985747|NCT00043186|147516735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.42|||<|0.001||95.0|8.12|14.73|||ANCOVA|||||14.73|8.12|<0.001
73985748|NCT00043186|147516735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.32|||<|0.001||95.0|9.15|15.49|||ANCOVA|||||15.49|9.15|<0.001
73985749|NCT00043186|147516735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.74|||<|0.001||95.0|8.72|14.76|||ANCOVA|||||14.76|8.72|<0.001
73985750|NCT00043186|147516736|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985751|NCT00043186|147516736|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985752|NCT00043186|147516736|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985753|NCT00043186|147516736|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985754|NCT00043186|147516736|SUPERIORITY_OR_OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
73985755|NCT00043186|147516736|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985756|NCT00043186|147516736|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985757|NCT00043186|147516736|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985758|NCT00043186|147516737|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
73985759|NCT00043186|147516737|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985760|NCT00043186|147516737|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
73985761|NCT00043186|147516737|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73985762|NCT00043186|147516737|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985763|NCT00043186|147516737|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985764|NCT00043186|147516737|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985765|NCT00043186|147516737|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985766|NCT00043186|147516738|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985767|NCT00043186|147516738|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
73985768|NCT00043186|147516738|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
73985769|NCT00043186|147516738|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73985770|NCT00043186|147516738|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
73985771|NCT00043186|147516738|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
73985772|NCT00043186|147516738|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73985773|NCT00043186|147516738|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985774|NCT00043186|147516739|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
73985775|NCT00043186|147516739|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
73985776|NCT00043186|147516739|SUPERIORITY_OR_OTHER|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
73985777|NCT00043186|147516739|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73985778|NCT00043186|147516739|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
73985779|NCT00043186|147516739|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
73985780|NCT00043186|147516739|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
73985781|NCT00043186|147516739|SUPERIORITY_OR_OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||||||0.073
73985782|NCT00043186|147516740|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985783|NCT00043186|147516740|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985784|NCT00043186|147516740|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73985785|NCT00043186|147516740|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985786|NCT00043186|147516740|SUPERIORITY_OR_OTHER|||||||0.409|||||||Wilcoxon (Mann-Whitney)|||||||0.409
73985787|NCT00043186|147516740|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985788|NCT00043186|147516740|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73985789|NCT00043186|147516740|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73985790|NCT00043186|147516741|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
73985791|NCT00043186|147516741|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985792|NCT00043186|147516741|SUPERIORITY_OR_OTHER|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
73985793|NCT00043186|147516741|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73985794|NCT00043186|147516741|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985795|NCT00043186|147516741|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73985796|NCT00043186|147516741|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73985797|NCT00043186|147516741|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73985798|NCT00043186|147516742|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
73985799|NCT00043186|147516742|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
74034382|NCT06704178|147621505|SUPERIORITY|||||||0.006||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.006
73875056|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.6515|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Post-switch memory B-cells||||0.6515
73985800|NCT00043186|147516742|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
73985801|NCT00043186|147516742|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
73985802|NCT00043186|147516742|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
73985803|NCT00043186|147516742|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
73985804|NCT00043186|147516742|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
73985805|NCT00043186|147516742|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
73985806|NCT00043186|147516743|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
73985807|NCT00043186|147516743|SUPERIORITY_OR_OTHER|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||||||0.172
73985808|NCT00043186|147516743|SUPERIORITY_OR_OTHER|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
73985809|NCT00043186|147516743|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
73985810|NCT00043186|147516743|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
73985811|NCT00043186|147516743|SUPERIORITY_OR_OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||||||0.168
73985812|NCT00043186|147516743|SUPERIORITY_OR_OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||||||0.168
73985813|NCT00043186|147516743|SUPERIORITY_OR_OTHER|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||||||0.172
73985814|NCT00043186|147516744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|||<|0.001||95.0|1.7|3.64|||ANCOVA|||||3.64|1.70|<0.001
73985815|NCT00043186|147516744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|||<|0.001||95.0|1.9|3.89|||ANCOVA|||||3.89|1.90|<0.001
73985816|NCT00043186|147516744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||<|0.001||95.0|2.07|4.11|||ANCOVA|||||4.11|2.07|<0.001
73985817|NCT00043186|147516744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12|||<|0.001||95.0|3.13|5.11|||ANCOVA|||||5.11|3.13|<0.001
73985818|NCT00043186|147516744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.001||95.0|1.55|3.46|||ANCOVA|||||3.46|1.55|<0.001
73985819|NCT00043186|147516744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.89|||<|0.001||95.0|2.83|4.95|||ANCOVA|||||4.95|2.83|<0.001
73985820|NCT00043186|147516744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|||<|0.001||95.0|1.99|4.04|||ANCOVA|||||4.04|1.99|<0.001
73985821|NCT00043186|147516744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.46|||<|0.001||95.0|2.43|4.48|||ANCOVA|||||4.48|2.43|<0.001
73985822|NCT00043186|147516745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19|||<|0.001||95.0|4.04|6.34|||ANCOVA|||||6.34|4.04|<0.001
73985823|NCT00043186|147516745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|||<|0.001||95.0|4.93|7.27|||ANCOVA|||||7.27|4.93|<0.001
73985824|NCT00043186|147516745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59|||<|0.001||95.0|4.4|6.78|||ANCOVA|||||6.78|4.40|<0.001
73985825|NCT00043186|147516745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.89|||<|0.001||95.0|5.76|8.01|||ANCOVA|||||8.01|5.76|<0.001
73985826|NCT00043186|147516745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|||<|0.001||95.0|3.41|5.67|||ANCOVA|||||5.67|3.41|<0.001
73985827|NCT00043186|147516745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.95|||<|0.001||95.0|5.69|8.21|||ANCOVA|||||8.21|5.69|<0.001
73985828|NCT00043186|147516745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|||<|0.001||95.0|4.29|6.67|||ANCOVA|||||6.67|4.29|<0.001
73985829|NCT00043186|147516745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.97|||<|0.001||95.0|4.76|7.17|||ANCOVA|||||7.17|4.76|<0.001
73985830|NCT00043186|147516746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.78|||<|0.001||95.0|2.19|5.36|||ANCOVA|||||5.36|2.19|<0.001
73985831|NCT00043186|147516746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.41||||0.07||95.0|-0.12|2.94|||ANCOVA|||||2.94|-0.12|0.07
73985832|NCT00043186|147516746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.17|||<|0.001||95.0|5.54|8.8|||ANCOVA|||||8.80|5.54|<0.001
73985833|NCT00043186|147516746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.67|||<|0.001||95.0|7.13|10.21|||ANCOVA|||||10.21|7.13|<0.001
73985834|NCT00043186|147516746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.15|||<|0.001||95.0|5.62|8.69|||ANCOVA|||||8.69|5.62|<0.001
74034383|NCT06704178|147621506|SUPERIORITY|||||||0.0219||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
74034384|NCT06704178|147621506|SUPERIORITY|||||||0.0001||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0001
74034385|NCT06704178|147621506|SUPERIORITY||||||<|0.0001||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||<0.0001
74034386|NCT06704178|147621507|SUPERIORITY|||||||0.0695||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0695
73985835|NCT00043186|147516746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61||||0.07||95.0|-0.12|3.35|||ANCOVA|||||3.35|-0.12|0.07
73985836|NCT00043186|147516746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.26|||<|0.001||95.0|5.56|8.95|||ANCOVA|||||8.95|5.56|<0.001
73985837|NCT00043186|147516746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.63|||<|0.001||95.0|6.02|9.24|||ANCOVA|||||9.24|6.02|<0.001
73985838|NCT00043186|147516747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.94||||0.002||95.0|1.86|8.02|||ANCOVA|||||8.02|1.86|0.002
73985839|NCT00043186|147516747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.677||95.0|-4.1|2.68|||ANCOVA|||||2.68|-4.10|0.677
73985840|NCT00043186|147516747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.66||||0.001||95.0|3.14|10.18|||ANCOVA|||||10.18|3.14|0.001
73985841|NCT00043186|147516747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.29|||<|0.001||95.0|5.26|11.33|||ANCOVA|||||11.33|5.26|<0.001
73985842|NCT00043186|147516747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||<|0.001||95.0|3.59|9.41|||ANCOVA|||||9.41|3.59|<0.001
73985843|NCT00043186|147516747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||0.047||95.0|0.61|8.05|||ANCOVA|||||8.05|0.61|0.047
73985844|NCT00043186|147516747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.94||||0.003||95.0|2.53|9.36|||ANCOVA|||||9.36|2.53|0.003
73985845|NCT00043186|147516747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.97||||0.001||95.0|3.28|10.66|||ANCOVA|||||10.66|3.28|0.001
73985846|NCT00043186|147516748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.69|||<|0.001||95.0|2.97|6.41|||ANCOVA|||||6.41|2.97|<0.001
73985847|NCT00043186|147516748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16||||0.015||95.0|0.43|3.89|||ANCOVA|||||3.89|0.43|0.015
74034387|NCT06704178|147621507|SUPERIORITY|||||||0.0124||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0124
73985848|NCT00043186|147516748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.52|||<|0.001||95.0|6.74|10.3|||ANCOVA|||||10.30|6.74|<0.001
73985849|NCT00043186|147516748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.58|||<|0.001||95.0|7.95|11.21|||ANCOVA|||||11.21|7.95|<0.001
73985850|NCT00043186|147516748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.34|||<|0.001||95.0|6.7|9.99|||ANCOVA|||||9.99|6.70|<0.001
73985851|NCT00043186|147516748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.38|||<|0.001||95.0|5.45|9.31|||ANCOVA|||||9.31|5.45|<0.001
73985852|NCT00043186|147516748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.55|||<|0.001||95.0|5.72|9.38|||ANCOVA|||||9.38|5.72|<0.001
73985853|NCT00043186|147516748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.97|||<|0.001||95.0|7.23|10.72|||ANCOVA|||||10.72|7.23|<0.001
73985854|NCT00043186|147516749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44||||0.033||95.0|0.11|2.76|||ANCOVA|||||2.76|0.11|0.033
73985855|NCT00043186|147516749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06|||<|0.001||95.0|1.69|4.42|||ANCOVA|||||4.42|1.69|<0.001
73985856|NCT00043186|147516749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.04|||<|0.001||95.0|1.68|4.4|||ANCOVA|||||4.40|1.68|<0.001
73985857|NCT00043186|147516749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|||<|0.001||95.0|1.94|4.57|||ANCOVA|||||4.57|1.94|<0.001
73985858|NCT00043186|147516749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.91|||<|0.001||95.0|1.6|4.21|||ANCOVA|||||4.21|1.60|<0.001
73985859|NCT00043186|147516749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.07|||<|0.001||95.0|1.65|4.49|||ANCOVA|||||4.49|1.65|<0.001
73985860|NCT00043186|147516749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37|||<|0.001||95.0|0.99|3.76|||ANCOVA|||||3.76|0.99|<0.001
73985861|NCT00043186|147516749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|||<|0.001||95.0|1.47|4.24|||ANCOVA|||||4.24|1.47|<0.001
73985862|NCT00043186|147516750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99||||0.009||95.0|0.49|3.49|||ANCOVA|||||3.49|0.49|0.009
73985863|NCT00043186|147516750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.58|||<|0.001||95.0|2.06|5.1|||ANCOVA|||||5.10|2.06|<0.001
73985864|NCT00043186|147516750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|||<|0.001||95.0|2.73|5.78|||ANCOVA|||||5.78|2.73|<0.001
73985865|NCT00043186|147516750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|||<|0.001||95.0|2.55|5.62|||ANCOVA|||||5.62|2.55|<0.001
73985866|NCT00043186|147516750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.67|||<|0.001||95.0|3.23|6.11|||ANCOVA|||||6.11|3.23|<0.001
73985867|NCT00043186|147516750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.26|||<|0.001||95.0|3.78|6.73|||ANCOVA|||||6.73|3.78|<0.001
73985868|NCT00043186|147516750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||<|0.001||95.0|2.48|5.68|||ANCOVA|||||5.68|2.48|<0.001
73985869|NCT00043186|147516750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39|||<|0.001||95.0|1.86|4.93|||ANCOVA|||||4.93|1.86|<0.001
73985870|NCT00043186|147516751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.69||||0.002||95.0|1.01|4.38|||ANCOVA|||||4.38|1.01|0.002
73985871|NCT00043186|147516751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.77|||<|0.001||95.0|2.14|5.39|||ANCOVA|||||5.39|2.14|<0.001
73985872|NCT00043186|147516751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||<|0.001||95.0|3.87|7.26|||ANCOVA|||||7.26|3.87|<0.001
73985873|NCT00043186|147516751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|||<|0.001||95.0|4.75|7.92|||ANCOVA|||||7.92|4.75|<0.001
73985874|NCT00043186|147516751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.73|||<|0.001||95.0|4.12|7.33|||ANCOVA|||||7.33|4.12|<0.001
73985875|NCT00043186|147516751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.89|6.5|||ANCOVA|||||6.50|2.89|<0.001
73985876|NCT00043186|147516751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.92|6.49|||ANCOVA|||||6.49|2.92|<0.001
73985877|NCT00043186|147516751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.63|||<|0.001||95.0|3.96|7.3|||ANCOVA|||||7.30|3.96|<0.001
74034388|NCT06704178|147621507|SUPERIORITY|||||||0.0016||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0016
74034389|NCT06704178|147621508|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73985878|NCT00043186|147516752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27||||0.496||95.0|-7.16|13.7|||ANCOVA|||||13.7|-7.16|0.496
73985879|NCT00043186|147516752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6||||0.527||95.0|-6.38|19.59|||ANCOVA|||||19.59|-6.38|0.527
73985880|NCT00043186|147516752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72||||0.503||95.0|-2.9|14.33|||ANCOVA|||||14.33|-2.90|0.503
73985881|NCT00043186|147516752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.68||||0.527||95.0|-6.54|11.89|||ANCOVA|||||11.89|-6.54|0.527
73985882|NCT00043186|147516752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41||||0.503||95.0|-2.19|17.01|||ANCOVA|||||17.01|-2.19|0.503
73985883|NCT00043186|147516752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.59||||0.503||95.0|-1.85|17.03|||ANCOVA|||||17.03|-1.85|0.503
74034390|NCT06704178|147621508|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034391|NCT06704178|147621508|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73985884|NCT00043186|147516752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.18||||0.503||95.0|-2.45|16.81|||ANCOVA|||||16.81|-2.45|0.503
73985885|NCT00043186|147516752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.88||||0.233||95.0|0.78|14.97|||ANCOVA|||||14.97|0.78|0.233
73985886|NCT00043186|147516753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.41|||<|0.001||95.0|4.48|8.34|||ANCOVA|||||8.34|4.48|<0.001
73985887|NCT00043186|147516753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.44|||<|0.001||95.0|4.19|8.7|||ANCOVA|||||8.70|4.19|<0.001
73985888|NCT00043186|147516753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.09|||<|0.001||95.0|3.91|8.26|||ANCOVA|||||8.26|3.91|<0.001
74034392|NCT06704178|147621508|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034393|NCT06704178|147621508|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73985889|NCT00043186|147516753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72|||<|0.001||95.0|3.7|7.73|||ANCOVA|||||7.73|3.70|<0.001
73985890|NCT00043186|147516753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.054||95.0|-0.04|4.04|||ANCOVA|||||4.04|-0.04|0.054
73985891|NCT00043186|147516753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.71|5.77|||ANCOVA|||||5.77|1.71|<0.001
73985892|NCT00043186|147516753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.05|||<|0.001||95.0|4.0|8.1|||ANCOVA|||||8.10|4.00|<0.001
73985893|NCT00043186|147516753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.39|||<|0.001||95.0|4.49|8.28|||ANCOVA|||||8.28|4.49|<0.001
73985894|NCT00043186|147516754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.001||95.0|1.09|3.51|||ANCOVA|||||3.51|1.09|0.001
73985895|NCT00043186|147516754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.73||||0.005||95.0|0.52|2.93|||ANCOVA|||||2.93|0.52|0.005
73985896|NCT00043186|147516754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.004||95.0|0.74|3.25|||ANCOVA|||||3.25|0.74|0.004
73985897|NCT00043186|147516754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|||<|0.001||95.0|1.54|3.91|||ANCOVA|||||3.91|1.54|<0.001
73985898|NCT00043186|147516754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.202||95.0|-0.41|1.95|||ANCOVA|||||1.95|-0.41|0.202
73985899|NCT00043186|147516754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.95|||<|0.001||95.0|1.65|4.26|||ANCOVA|||||4.26|1.65|<0.001
73985900|NCT00043186|147516754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.004||95.0|0.78|3.26|||ANCOVA|||||3.26|0.78|0.004
73985901|NCT00043186|147516754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.004||95.0|0.8|3.27|||ANCOVA|||||3.27|0.80|0.004
73985902|NCT00043186|147516755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.14|||<|0.001||95.0|1.71|4.56|||ANCOVA|||||4.56|1.71|<0.001
73985903|NCT00043186|147516755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|||<|0.001||95.0|2.95|5.84|||ANCOVA|||||5.84|2.95|<0.001
73985904|NCT00043186|147516755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.64|||<|0.001||95.0|3.19|6.09|||ANCOVA|||||6.09|3.19|<0.001
73985905|NCT00043186|147516755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.22|||<|0.001||95.0|2.85|5.58|||ANCOVA|||||5.58|2.85|<0.001
73985906|NCT00043186|147516755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.53|||<|0.001||95.0|1.13|3.94|||ANCOVA|||||3.94|1.13|<0.001
73985907|NCT00043186|147516755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.09|||<|0.001||95.0|4.53|7.64|||ANCOVA|||||7.64|4.53|<0.001
73985908|NCT00043186|147516755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.55|||<|0.001||95.0|3.12|5.98|||ANCOVA|||||5.98|3.12|<0.001
74034394|NCT06704178|147621508|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034395|NCT06704178|147621509|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034396|NCT06704178|147621509|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034397|NCT06704178|147621509|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034398|NCT06704178|147621509|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034399|NCT06704178|147621509|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034400|NCT06704178|147621509|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034401|NCT06704178|147621510|SUPERIORITY|||||||0.4598||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4598
74034402|NCT06704178|147621510|SUPERIORITY|||||||0.23||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.23
74034403|NCT06704178|147621510|SUPERIORITY|||||||0.0806||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0806
74034404|NCT06704178|147621510|SUPERIORITY|||||||0.0969||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0969
74034405|NCT06704178|147621510|SUPERIORITY|||||||0.6098||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6098
74034406|NCT06704178|147621510|SUPERIORITY|||||||0.0369||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0369
74034407|NCT06704178|147621511|SUPERIORITY|||||||0.0384||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0384
74034408|NCT06704178|147621511|SUPERIORITY|||||||0.6328||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6328
73985909|NCT00043186|147516755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|||<|0.001||95.0|2.76|5.69|||ANCOVA|||||5.69|2.76|<0.001
73985910|NCT00043186|147516756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.16|||<|0.001||95.0|3.63|8.68|||ANCOVA|||||8.68|3.63|<0.001
73985911|NCT00043186|147516756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.275||95.0|-1.06|3.7|||ANCOVA|||||3.7|-1.06|0.275
74034409|NCT06704178|147621511|SUPERIORITY|||||||0.0026||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0026
74034410|NCT06704178|147621511|SUPERIORITY|||||||0.0012||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0012
74034411|NCT06704178|147621511|SUPERIORITY|||||||0.0118||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0118
73985912|NCT00043186|147516756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.005||95.0|1.65|6.75|||ANCOVA|||||6.75|1.65|0.005
73985913|NCT00043186|147516756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.41||||0.002||95.0|2.07|6.75|||ANCOVA|||||6.75|2.07|0.002
73985914|NCT00043186|147516756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65||||0.009||95.0|1.25|6.05|||ANCOVA|||||6.05|1.25|0.009
73985915|NCT00043186|147516756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95||||0.009||95.0|1.22|6.68|||ANCOVA|||||6.68|1.22|0.009
73985916|NCT00043186|147516756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.65||||0.003||95.0|2.05|7.24|||ANCOVA|||||7.24|2.05|0.003
73985917|NCT00043186|147516756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75||||0.001||95.0|2.28|7.22|||ANCOVA|||||7.22|2.28|0.001
73985918|NCT00043186|147516757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.18||||0.949||95.0|-8.73|13.1|||ANCOVA|||||13.10|-8.73|0.949
73985919|NCT00043186|147516757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.949||95.0|-2.7|9.31|||ANCOVA|||||9.31|-2.70|0.949
73985920|NCT00043186|147516757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.709||95.0|-6.81|9.29|||ANCOVA|||||9.29|-6.81|0.709
73985921|NCT00043186|147516757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36||||0.949||95.0|-8.55|3.83|||ANCOVA|||||3.83|-8.55|0.949
73985922|NCT00043186|147516757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.949||95.0|-4.51|8.72|||ANCOVA|||||8.72|-4.51|0.949
73985923|NCT00043186|147516757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.23||||0.484||95.0|-0.83|15.3|||ANCOVA|||||15.3|-0.83|0.484
73985924|NCT00043186|147516757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.949||95.0|-3.77|8.66|||ANCOVA|||||8.66|-3.77|0.949
73985925|NCT00043186|147516757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.949||95.0|-10.82|11.4|||ANCOVA|||||11.40|-10.82|0.949
73985926|NCT00043186|147516758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.02|||<|0.001||95.0|4.35|9.69|||ANCOVA|||||9.69|4.35|<0.001
74034412|NCT06704178|147621511|SUPERIORITY|||||||0.0221||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0221
74034413|NCT06704178|147621512|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034414|NCT06704178|147621512|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034415|NCT06704178|147621512|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034416|NCT06704178|147621512|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034417|NCT06704178|147621512|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034418|NCT06704178|147621512|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034419|NCT06704178|147621513|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034420|NCT06704178|147621513|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034421|NCT06704178|147621513|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034422|NCT06704178|147621513|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034423|NCT06704178|147621513|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034424|NCT06704178|147621513|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034425|NCT06704178|147621514|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034426|NCT06704178|147621514|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034427|NCT06704178|147621514|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034428|NCT06704178|147621514|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034429|NCT06704178|147621514|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034430|NCT06704178|147621514|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034431|NCT06704178|147621515|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034432|NCT06704178|147621515|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034433|NCT06704178|147621515|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73985927|NCT00043186|147516758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.25||||0.092||95.0|-0.37|4.87|||ANCOVA|||||4.87|-0.37|0.092
73985928|NCT00043186|147516758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.5|8.94|||ANCOVA|||||8.94|3.50|<0.001
73985929|NCT00043186|147516758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.97|||<|0.001||95.0|3.51|8.43|||ANCOVA|||||8.43|3.51|<0.001
73985930|NCT00043186|147516758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.96|||<|0.001||95.0|3.44|8.48|||ANCOVA|||||8.48|3.44|<0.001
73985931|NCT00043186|147516758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.29|||<|0.001||95.0|3.25|9.34|||ANCOVA|||||9.34|3.25|<0.001
73985932|NCT00043186|147516758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|||<|0.001||95.0|3.13|8.7|||ANCOVA|||||8.70|3.13|<0.001
73985933|NCT00043186|147516758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.58|8.87|||ANCOVA|||||8.87|3.58|<0.001
73985934|NCT00043186|147516759|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985935|NCT00043186|147516759|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74034434|NCT06704178|147621515|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73985936|NCT00043186|147516759|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985937|NCT00043186|147516759|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985938|NCT00043186|147516759|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985939|NCT00043186|147516759|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985940|NCT00043186|147516759|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985941|NCT00043186|147516759|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985942|NCT00043186|147516760|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985943|NCT00043186|147516760|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985944|NCT00043186|147516760|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985945|NCT00043186|147516760|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985946|NCT00043186|147516760|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73985947|NCT00043186|147516760|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985948|NCT00043186|147516760|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985949|NCT00043186|147516760|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985950|NCT00043186|147516761|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
73985951|NCT00043186|147516761|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
73985952|NCT00043186|147516761|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985953|NCT00043186|147516761|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985954|NCT00043186|147516761|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985955|NCT00043186|147516761|SUPERIORITY_OR_OTHER|||||||0.146|||||||Wilcoxon (Mann-Whitney)|||||||0.146
73985956|NCT00043186|147516761|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73985957|NCT00043186|147516761|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985958|NCT00043186|147516762|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
73985959|NCT00043186|147516762|SUPERIORITY_OR_OTHER|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
73985960|NCT00043186|147516762|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73985961|NCT00043186|147516762|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985962|NCT00043186|147516762|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985963|NCT00043186|147516762|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73985964|NCT00043186|147516762|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73985965|NCT00043186|147516762|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73985966|NCT00043186|147516763|SUPERIORITY_OR_OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||||||0.142
73985967|NCT00043186|147516763|SUPERIORITY_OR_OTHER|||||||0.218|||||||Wilcoxon (Mann-Whitney)|||||||0.218
73985968|NCT00043186|147516763|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73985969|NCT00043186|147516763|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
73985970|NCT00043186|147516763|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73985971|NCT00043186|147516763|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
73985972|NCT00043186|147516763|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
73985973|NCT00043186|147516763|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
73985974|NCT03722485|147516764|SUPERIORITY|||||||0.292||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Regression, Linear|Test of treatment effect using a generalized linear model with treatment arm, baseline values, and clinical site as factors.||||||0.2920
73985975|NCT03722485|147516765|SUPERIORITY|||||||0.0213||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Wilcoxon (Mann-Whitney)|||||||0.0213
73985976|NCT03722485|147516766|SUPERIORITY|||||||0.7422||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Wilcoxon (Mann-Whitney)|||||||0.7422
73985977|NCT03722485|147516767|SUPERIORITY|||||||0.6322|||||||Fisher Exact|||||||0.6322
74034435|NCT06704178|147621515|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034436|NCT06704178|147621515|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034437|NCT06704178|147621516|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875057|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.8413|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, IgG-positive class-switched B-cells||||0.8413
73985978|NCT05012280|147516785|SUPERIORITY||Odds Ratio (OR)|1.221||||0.115|TWO_SIDED|95.0|0.953|1.564||only one primary endpoint, p value not adjusted for multiple comparisons. A priori treshold or statistical significance: p=0.05|Regression, Logistic|conditional logistic regression for matched case control||||1.564|0.953|0.1150
73985979|NCT05012280|147516785|SUPERIORITY||Odds Ratio (OR)|1.221||||0.12|TWO_SIDED|95.0|0.953|1.564|||Regression, Logistic|conditional logistic regression for matched case control study.||||1.564|0.953|0.12
73985980|NCT02762500|147516788|SUPERIORITY||Risk Difference (RD)|-8.1||||0.106|TWO_SIDED|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||2.5|-18.6|0.106
73985981|NCT02762500|147516789|SUPERIORITY||Risk Difference (RD)|-8.1||||0.106|TWO_SIDED|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||2.5|-18.6|0.106
73985982|NCT02762500|147516790|SUPERIORITY||Risk Difference (RD)|-6.5||||0.235|TWO_SIDED|90.0|-21.1|8.2||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||8.2|-21.1|0.235
73985983|NCT02762500|147516791|SUPERIORITY||Risk Difference (RD)|-9.7||||0.14|TWO_SIDED|90.0|-24.3|5.0||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||5.0|-24.3|0.140
73985984|NCT02762500|147516792|SUPERIORITY||Mean Difference (Final Values)|-44.59||||0.032|TWO_SIDED|90.0|-78.66|-10.53|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.||Subjects included in this analysis were those with a baseline fecal calprotectin value ≥ 250 µg/g.||-10.53|-78.66|0.032
73985985|NCT02762500|147516793|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.708|TWO_SIDED|90.0|-0.6|0.95|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.||||0.95|-0.60|0.708
73985986|NCT02229396|147516795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.129||0.003|TWO_SIDED|95.0|-0.63|-0.13|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.13|-0.63|0.003
73985987|NCT02229396|147516795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.127|<|0.001|TWO_SIDED|95.0|-0.84|-0.34|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.34|-0.84|<0.001
73985988|NCT02229396|147516796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.406|<|0.001|TWO_SIDED|95.0|-2.79|-1.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-1.20|-2.79|<0.001
73985989|NCT02229396|147516796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.12|-0.55|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.55|-2.12|<0.001
74034438|NCT06704178|147621516|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73985990|NCT02229396|147516797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.08|STANDARD_ERROR_OF_MEAN|4.007|<|0.001|TWO_SIDED|95.0|-27.95|-12.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-12.20|-27.95|<0.001
73985991|NCT02229396|147516797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.64|STANDARD_ERROR_OF_MEAN|3.947|<|0.001|TWO_SIDED|95.0|-24.39|-8.89|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-8.89|-24.39|<0.001
73985992|NCT02229396|147516798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.74|STANDARD_ERROR_OF_MEAN|5.168|<|0.001|TWO_SIDED|95.0|-37.89|-17.59|||ANCOVA|Treatment, region, and baseline HbA1c stratum (\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.||||-17.59|-37.89|<0.001
73985993|NCT02229396|147516798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.78|STANDARD_ERROR_OF_MEAN|5.09|<|0.001|TWO_SIDED|95.0|-36.78|-16.78|||ANCOVA|Treatment, region, and baseline HbA1c stratum (\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.||||-16.78|-36.78|<0.001
73985994|NCT02229396|147516799|SUPERIORITY_OR_OTHER||Difference in percentages|19.7|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
73985995|NCT02229396|147516799|SUPERIORITY_OR_OTHER||Difference in percentages|13.3||||0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||0.001
73985996|NCT02229396|147516800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.26|STANDARD_ERROR_OF_MEAN|3.494|<|0.001|TWO_SIDED|95.0|-27.12|-13.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-13.40|-27.12|<0.001
74034439|NCT06704178|147621516|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034440|NCT06704178|147621516|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73985997|NCT02229396|147516800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.03|STANDARD_ERROR_OF_MEAN|3.477|<|0.001|TWO_SIDED|95.0|-21.85|-8.2||This is a nominal p-value.|Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-8.20|-21.85|<0.001
73985998|NCT02229396|147516801|SUPERIORITY_OR_OTHER||Difference in percentages|17.9|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
73875058|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.7244|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, IgA-positive class-switched B-cells||||0.7244
73875059|NCT01332994|147291737|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Double-negative B-cells||||<0.0001
73985999|NCT02229396|147516801|SUPERIORITY_OR_OTHER||Difference in percentages|25.6|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
73986000|NCT02229396|147516802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.08||0.005|TWO_SIDED|95.0|-5.2|-0.9|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.9|-5.2|0.005
73986001|NCT02229396|147516802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.06||0.022|TWO_SIDED|95.0|-4.5|-0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.4|-4.5|0.022
73986002|NCT03245762|147516821|SUPERIORITY||Odds Ratio (OR)|0.9||||0.93|TWO_SIDED||||||Ordinal Categorical Analysis|||||||0.930
73986003|NCT03935932|147516829|OTHER|||||||0.11|||||||Wilcoxon signed-rank|||||||0.11
73986004|NCT03935932|147516830|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
73986005|NCT03935932|147516831|OTHER|||||||0.35|||||||Wilcoxon signed-rank|||||||0.35
73986006|NCT00382408|147516857|SUPERIORITY_OR_OTHER||vaccine efficacy (VE)|99.31|||||TWO_SIDED|95.0|96.02|99.88||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.||99.88|96.02|
73875060|NCT01332994|147291737|SUPERIORITY_OR_OTHER|||||||0.3848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Plasmablasts||||0.3848
73875061|NCT00279916|147291756|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
73986007|NCT00382408|147516862|SUPERIORITY_OR_OTHER||vaccine efficacy (VE)|98.46|||||TWO_SIDED|95.0|95.39|99.49||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.||99.49|95.39|
73875062|NCT00279916|147291757|SUPERIORITY|||||||0.24|||||||Chi-squared|||||||0.24
73875063|NCT02717494|147291773|OTHER||% with grade 3+ AEs, up to week 4 Step 1|2.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
73875064|NCT02717494|147291773|OTHER||% with grade 3+ AEs, up to week 4 Step 1|3.0|||||TWO_SIDED|90.0|1.0|7.0|||||Confidence intervals were Exact Clopper-Pearson.|||7|1|
73875065|NCT02717494|147291773|OTHER||% with grade 3+ AEs up to week 4, Step 1|3.0|||||TWO_SIDED|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.|||8|1|
73875066|NCT02717494|147291773|OTHER||% with grade 4+ AEs after week 4, Step 1|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
73986008|NCT00871143|147516867|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.||||<.001
73986009|NCT00871143|147516867|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12||||<.001
73986010|NCT00871143|147516867|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of Type 1 error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between between baseline and 1 month follow up||||< .001
73986011|NCT00871143|147516867|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12||||<.01
73986012|NCT00871143|147516867|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and 1 month follow up||||< 0.05
73986013|NCT00871143|147516868|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.||||<.05
73986014|NCT00871143|147516868|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week measures||||<0.01
73986015|NCT00871143|147516868|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were implemented to adjust for type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up.||||< 0.001
73986016|NCT00871143|147516868|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week assessment measures and baseline and 1 month follow up measures.||||>0.05
74034441|NCT06704178|147621516|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875067|NCT02717494|147291773|OTHER||% with grade 4+ AEs after week 4, Step 1|2.0|||||TWO_SIDED|90.0|0.0|5.0|||||||Confidence intervals were Exact Clopper-Pearson.|5|0|
73875068|NCT02717494|147291773|OTHER||% with grade 4+ AEs, after week 4 Step 1|3.0|||||TWO_SIDED|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.|||8|1|
73875069|NCT02717494|147291773|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
73875070|NCT02717494|147291773|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
73875071|NCT02717494|147291773|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
73986017|NCT00871143|147516868|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up measures.||||>0.05
73875072|NCT02717494|147291774|OTHER||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
73875073|NCT02717494|147291774|OTHER||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
73875074|NCT02717494|147291775|OTHER||% infants with grade 3+ AEs|21.0|||||TWO_SIDED|90.0|14.0|28.0|||||Confidence intervals were Exact Clopper-Pearson.|||28|14|
73875075|NCT02717494|147291775|OTHER||% infants with grade 3+ AEs|20.0|||||TWO_SIDED|90.0|14.0|27.0|||||||Confidence intervals were Exact Clopper-Pearson.|27|14|
73875076|NCT02717494|147291775|OTHER||% infants with grade 3+ AEs|20.0|||||TWO_SIDED|90.0|14.0|27.0|||||Confidence intervals were Exact Clopper-Pearson.|||27|14|
73875077|NCT02717494|147291775|OTHER||% infants with congenital anomalies|17.0|||||TWO_SIDED|90.0|11.0|24.0|||||||Confidence intervals were Exact Clopper-Pearson.|24|11|
73875078|NCT02717494|147291775|OTHER||% infants with congenital anomalies|22.0|||||TWO_SIDED|90.0|15.0|29.0|||||||Confidence intervals were Exact Clopper-Pearson.|29|15|
73875079|NCT02717494|147291775|OTHER||% infants with congenital anomalies|13.0|||||TWO_SIDED|90.0|8.0|19.0|||||Confidence intervals were Exact Clopper-Pearson.|||19|8|
73875080|NCT02717494|147291775|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|3.0|||||||Confidence intervals were Exact Clopper-Pearson.|3|0|
73875081|NCT02717494|147291775|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|3.0|||||Confidence intervals were Exact Clopper-Pearson.|||3|0|
73986018|NCT00871143|147516869|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||A Linear mixed model was conducted to determine the predictive value of treatment group and/or time on the outcome variable MADRS scores.||||>0.05
73986019|NCT00871143|147516869|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.||||<0.01
73986020|NCT00871143|147516869|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferonni corrections used to reduce risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.||||>0.05
73986021|NCT00871143|147516869|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.||||>0.05
73986022|NCT00871143|147516869|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.||||> 0.05
73986023|NCT00871143|147516870|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable of AAI scores.||||<0.05
73986024|NCT00871143|147516870|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were applied to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .||||<0.001
73986025|NCT00871143|147516870|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.||||< 0.001
73986026|NCT00871143|147516870|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni Correction was used in an attempt to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .||||<0.05
73875082|NCT02717494|147291775|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|2.0|||||Confidence intervals were Exact Clopper-Pearson.|||2|0|
73875083|NCT02717494|147291775|OTHER||% with pneumonia, meningitis or IPD|4.0|||||TWO_SIDED|90.0|2.0|9.0|||||Confidence intervals were Exact Clopper-Pearson.|||9|2|
73875084|NCT02717494|147291775|OTHER||% with pneumonia, meningitis or IPD|7.0|||||TWO_SIDED|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
73875085|NCT02717494|147291775|OTHER||% with pneumonia, meningitis or IPD|7.0|||||TWO_SIDED|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
73875086|NCT02717494|147291776|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at day 28.||||||0.44||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.44
73875087|NCT02717494|147291776|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with values \>=0.35ug/mL at day 28.||||||0.49||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.49
73875088|NCT02717494|147291776|OTHER||% vaccinees with >=2fold increase|96.0|||||TWO_SIDED|95.0|91.0|99.0|||||Confidence intervals were Exact Clopper-Pearson.|||99|91|
73986027|NCT00871143|147516870|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to adjust for type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.||||>0.05
73986028|NCT00871143|147516871|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the PHQ-9 score.||||>0.05
73875089|NCT02717494|147291776|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|94.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|94|
73875090|NCT02717494|147291776|OTHER||% with >=2 fold increase|6.0|||||TWO_SIDED|95.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
73875091|NCT02717494|147291776|OTHER||% vaccinees with >=0.35ug/mL at day 28|99.0|||||TWO_SIDED|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|95|
73875092|NCT02717494|147291776|OTHER||% vaccinees with >=0.35ug/mL at day 28|100.0|||||TWO_SIDED|95.0|97.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|97|
74034442|NCT06704178|147621516|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034443|NCT06704178|147621517|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034444|NCT06704178|147621517|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034445|NCT06704178|147621517|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74089710|NCT03545191|147732307|OTHER||LS mean difference to placebo|-1.75|||<|1e-05|TWO_SIDED|95.0|-2.508|-0.983||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 50 mg vs placebo).||-0.983|-2.508|< .00001
74034446|NCT06704178|147621517|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875093|NCT02717494|147291776|OTHER||% with >=0.35ug/mL at day 28|94.0|||||TWO_SIDED|95.0|88.0|97.0|||||Confidence intervals were Exact Clopper-Pearson.|||97|88|
73875094|NCT02717494|147291777|SUPERIORITY|||||||0.29||||||The threshold for statistical significance is 0.05.|Chi-squared|||||||0.29
73875095|NCT02717494|147291778|SUPERIORITY|||||||0.08||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.08
73956395|NCT01879371|147448699|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|107.85|||||TWO_SIDED|90.0|105.334|110.431|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|"The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect.~The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested."||110.431|105.334|
73875096|NCT02717494|147291779|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at labor and delivery.||||||0.37||||||The threshold for statistical significance is 0.05.|Chi-squared|||||||0.37
73875097|NCT02717494|147291779|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at 24 weeks post partum.||||||0.21|||||||Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.21
73875098|NCT02717494|147291780|OTHER||% vaccinees with >=2fold increase|96.0|||||TWO_SIDED|95.0|91.0|99.0||The threshold for statistical significance is 0.05.|||Confidence intervals were Exact Clopper-Pearson.|||99|91|
73875099|NCT02717494|147291780|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|89.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|89|
73875100|NCT02717494|147291781|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|94.0|100.0|||||||Confidence intervals were Exact Clopper-Pearson.|100|94|
73875101|NCT02717494|147291781|OTHER||% vaccinees with >=2fold increase|100.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
73875102|NCT02717494|147291782|OTHER||% infants with >=0.35ug/mL at week 16|100.0|||||TWO_SIDED|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|96|
73875103|NCT02717494|147291782|OTHER||% infants with >=0.35ug/mL at week 16|98.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
73875104|NCT02717494|147291782|OTHER||% infants with >=0.35ug/mL at week 16|97.0|||||TWO_SIDED|95.0|91.0|99.0|||||||Confidence intervals were Exact Clopper-Pearson.|99|91|
73875105|NCT02717494|147291782|OTHER||% infants with >=0.35ug/mL at week 24|100.0|||||TWO_SIDED|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|96|
74034447|NCT06704178|147621517|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034448|NCT06704178|147621517|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034449|NCT06704178|147621518|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034450|NCT06704178|147621518|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034451|NCT06704178|147621518|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034452|NCT06704178|147621518|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034453|NCT06704178|147621518|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034454|NCT06704178|147621518|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034455|NCT06704178|147621519|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034456|NCT06704178|147621519|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034457|NCT06704178|147621519|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034458|NCT06704178|147621519|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034459|NCT06704178|147621519|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034460|NCT06704178|147621519|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034461|NCT06704178|147621520|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875106|NCT02717494|147291782|OTHER||% infants with >=0.35ug/mL at week 24|99.0|||||TWO_SIDED|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|95|
73875107|NCT02717494|147291782|OTHER||% infants with >=0.35ug/mL at week 24|98.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
73986029|NCT00871143|147516871|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Where more than 1 t test had been conducted on each variable, a Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).||||<0.05
73986030|NCT00871143|147516871|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.||||> 0.05
73986031|NCT00871143|147516871|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).||||>0.05
73986032|NCT00871143|147516871|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.||||> 0.05
73986033|NCT00871143|147516872|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on GAD-7 scores.||||<0.05
73986034|NCT00871143|147516872|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.||||<0.01
73986035|NCT00871143|147516872|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were implemented to reduce the risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.||||> 0.05
73986036|NCT00871143|147516872|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.||||>0.05
73986037|NCT00871143|147516872|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.||||> 0.05
73986038|NCT00871143|147516873|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on BIQLI scores.||||<0.05
73986039|NCT00871143|147516873|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).||||<0.05
74034462|NCT06704178|147621520|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034463|NCT06704178|147621520|SUPERIORITY|||||||0.3682||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3682
73986040|NCT00871143|147516873|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.||||< 0.05
73986041|NCT00871143|147516873|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).||||>0.05
73986042|NCT00871143|147516873|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.||||> 0.05
73986043|NCT00352053|147516874|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline genotypic sensitivity score (GSS) (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.55
74034464|NCT06704178|147621520|SUPERIORITY|||||||0.6098||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6098
74034465|NCT06704178|147621520|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034466|NCT06704178|147621520|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034467|NCT06704178|147621521|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034468|NCT06704178|147621521|SUPERIORITY|||||||0.5691||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.5691
74034469|NCT06704178|147621521|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034470|NCT06704178|147621521|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875108|NCT00676013|147291785|OTHER|ANOVA and all pairwise comparisons using Tukey test.|Multiple pairwise comparisons|0.05||||0.05|TWO_SIDED|||||0.05 is a threshold for statistical significance.|ANOVA|||We conducted a multiple four group comparison (all pairwise comparisons were conducted). An Anova was conducted to assess statistical significance.|0.05|||0.05
73875109|NCT00428948|147291786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.708|||<|0.0001|TWO_SIDED|95.0|-3.269|-2.147|||Linear mixed model||The variance of the random effect intercept was zero and resulted in a non-positive, definite variance-covariance matrix for the random effects.|The null hypothesis was that there was no difference in the percentage change per year in total kidney volume between the tolvaptan group and the placebo group.||-2.147|-3.269|<0.0001
73986044|NCT00352053|147516875|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.40
73986045|NCT00352053|147516876|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.58
74034471|NCT06704178|147621521|SUPERIORITY|||||||0.6983||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6983
74034472|NCT06704178|147621521|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034473|NCT06704178|147621522|SUPERIORITY|||||||0.819||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.819
74034474|NCT06704178|147621522|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034475|NCT06704178|147621522|SUPERIORITY|||||||0.5749||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.5749
74089711|NCT03545191|147732308|OTHER||LS mean difference to placebo|-0.99||||0.0534|TWO_SIDED|95.0|-1.99|0.014||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 25 mg vs placebo).||0.014|-1.990|0.0534
73986046|NCT00352053|147516877|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.37
74034476|NCT06704178|147621522|SUPERIORITY|||||||0.4873||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4873
74034477|NCT06704178|147621522|SUPERIORITY|||||||0.9998||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9998
74034478|NCT06704178|147621522|SUPERIORITY|||||||0.819||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.819
73875110|NCT00428948|147291787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.865||||0.0095|TWO_SIDED|95.0|0.775|0.965|||Recurrent event analysis||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the ADPKD clinical progression events/100 follow-up years between the tolvaptan group and the placebo group.||0.965|0.775|0.0095
74034479|NCT06704178|147621523|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034480|NCT06704178|147621523|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034481|NCT06704178|147621523|SUPERIORITY|||||||0.8495||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8495
74034482|NCT06704178|147621523|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||>0.9999
74034483|NCT06704178|147621523|SUPERIORITY|||||||0.1951||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1951
74034484|NCT06704178|147621523|SUPERIORITY|||||||0.0806||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||0.0806
74034485|NCT06704178|147621524|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034486|NCT06704178|147621524|SUPERIORITY|||||||0.6983||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6983
74034487|NCT06704178|147621524|SUPERIORITY|||||||0.1062||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1062
74034488|NCT06704178|147621524|SUPERIORITY|||||||0.0333||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0333
74034489|NCT06704178|147621524|SUPERIORITY|||||||0.0734||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0734
74034490|NCT06704178|147621524|SUPERIORITY|||||||0.0219||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
74034491|NCT06704178|147621525|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034492|NCT06704178|147621525|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034493|NCT06704178|147621525|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034494|NCT06704178|147621525|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034495|NCT06704178|147621525|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034496|NCT06704178|147621525|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034497|NCT06704178|147621526|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034498|NCT06704178|147621526|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875111|NCT00428948|147291788|SUPERIORITY_OR_OTHER||Difference in slope|0.977|||<|0.0001|TWO_SIDED|95.0|0.597|1.357|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.||The null hypothesis was that there was no difference in the change in renal function per year between the tolvaptan group and the placebo group.||1.357|0.597|<0.0001
73986047|NCT00352053|147516884|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).||||0.71
73986048|NCT00352053|147516885|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).||||0.47
73986049|NCT00352053|147516892|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4% for the tenofovir DF and placebo groups are different (two-sided).||||0.26
73986050|NCT00352053|147516893|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4% for the tenofovir DF and placebo groups are different (two-sided).||||0.63
73986051|NCT00352053|147516900|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).||||0.67
73986052|NCT00352053|147516901|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).||||0.67
73986053|NCT00352053|147516908|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).||||1.00
74034499|NCT06704178|147621526|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034500|NCT06704178|147621526|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73986054|NCT00352053|147516909|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).||||0.38
74034501|NCT06704178|147621526|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034502|NCT06704178|147621526|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875112|NCT00428948|147291789|SUPERIORITY_OR_OTHER||Difference in slope|-0.246||||0.552|TWO_SIDED|95.0|-1.059|0.566|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.|Placebo minus tolvaptan.|The null hypothesis was that there was no difference in mean arterial blood pressure in non-hypertensive participants between the tolvaptan group and the placebo group.||0.566|-1.059|0.5520
74034503|NCT06704178|147621527|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034504|NCT06704178|147621527|SUPERIORITY|||||||0.982||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.982
74034505|NCT06704178|147621527|SUPERIORITY|||||||0.091||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.091
74034506|NCT06704178|147621527|SUPERIORITY|||||||0.4449||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4449
74034507|NCT06704178|147621527|SUPERIORITY|||||||0.0204||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0204
73986055|NCT00352053|147516916|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).||||0.22
73986056|NCT00352053|147516917|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).||||0.48
73986057|NCT00352053|147516924|SUPERIORITY_OR_OTHER|||||||0.29||95.0||||No adjustments for multiple comparisons were made.|Log Rank|No adjustments were made.||Null hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are equal. Alternative hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are different (two-sided).||||0.29
73986058|NCT01066897|147516925|OTHER|||||||0.002|||||||Chi-squared|||||||.002
74034508|NCT06704178|147621527|SUPERIORITY|||||||0.0256||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0256
74034509|NCT06704178|147621528|SUPERIORITY|||||||0.9821||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9821
73875113|NCT00428948|147291790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.1604|TWO_SIDED|95.0|-0.2|0.03|||ANCOVA|The analysis included baseline renal pain as a covariate.|Derived from ANCOVA with factors of treatment and baseline stratification factor interaction and covariate renal pain baseline.|The null hypothesis was that there was no difference in the change in renal pain between the tolvaptan group and the placebo group.||0.03|-0.20|0.1604
73875114|NCT00428948|147291791|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.9704|TWO_SIDED|95.0|0.805|1.233|||Recurrent event analysis||Derived from rate and mean model of time to recurrent event analysis with factor treatment.|The null hypothesis was that there was no difference in the hypertensive events per 100 follow-up years in non-hypertensive participants between the tolvaptan group and the placebo group.||1.233|0.805|0.9704
73986059|NCT01066897|147516926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.368|STANDARD_DEVIATION|0.44||0.067|TWO_SIDED||||||t-test, 2 sided|One sample t-test to determine if the % change in HAMD was different from 0||For the 2 dropouts, used LOCF.||||.067
73986060|NCT02402465|147516929|SUPERIORITY||Mean Difference (Final Values)|37.0|||>|0.05|TWO_SIDED||||||ANOVA||Mean difference is related to albumin levels in nasal lavages: Unit= ng/ml|||||>0.05
73986061|NCT02402465|147516930|SUPERIORITY||Friedman's Q|14.2||||0.001|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately yielding alpha=0.05/3.|Friedman|Non-parametric repeated measures ANOVA||||||0.001
73986062|NCT02402465|147516930|SUPERIORITY||Median Difference (Net)|24.5||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
73986063|NCT02402465|147516930|SUPERIORITY||Median Difference (Net)|4.5||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
73986064|NCT02402465|147516930|SUPERIORITY||Median Difference (Net)|48.5||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.53
73986065|NCT02402465|147516931|SUPERIORITY||Friedman's Q|5.22||||0.07|TWO_SIDED|||||Alpha=0.05/3 since 3 days are compared|Friedman's Test|||We used Friedman test to compare the distribution of total nasal symptom scores among three treatment groups (Placebo, Fluticasone propionate, Dymista) in each of the three days (day 1, day 2, and day 3).||||0.07
73986066|NCT02402465|147516932|SUPERIORITY||Friedman's Q|5.06||||0.08|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.08
73986067|NCT02402465|147516934|SUPERIORITY||Friedman's Q|6.53||||0.04|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.04
73986068|NCT02402465|147516935|SUPERIORITY||Friedman's Q|0.53|||>|0.05|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||>0.05
73986069|NCT02402465|147516936|SUPERIORITY||Friedman's Q|0.33||||0.85|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.85
73986070|NCT03807700|147516937|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.58||0.4769|TWO_SIDED|95.0|-1.56|0.74|||ANCOVA|Analysis was performed using ANCOVA model with study product as a fixed effect and Baseline overall score as a covariate.|Difference is experimental adhesive minus no adhesive.|||0.74|-1.56|0.4769
74034510|NCT06704178|147621528|SUPERIORITY|||||||0.0403||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0403
74034511|NCT06704178|147621528|SUPERIORITY|||||||0.0638||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0638
74034512|NCT06704178|147621528|SUPERIORITY|||||||0.7195||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7195
74034513|NCT06704178|147621528|SUPERIORITY|||||||0.1856||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1856
73986071|NCT00595764|147516979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.4||0.91|TWO_SIDED|95.0|||||ANOVA|||With an effect size of 0.46, a sample size of 140 will provide a power of \>.84 with p\<.05 to detect overall differences between the two treatments on the primary outcome measures.||||.91
73986072|NCT00595764|147516981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.32||0.29|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.29
73986073|NCT00595764|147516982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.029||0.58|TWO_SIDED|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.||||||.58
73986074|NCT00595764|147516983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.38|STANDARD_ERROR_OF_MEAN|3.63||0.24|TWO_SIDED|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.||||||.24
74034514|NCT06704178|147621528|SUPERIORITY|||||||0.1222||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1222
74034515|NCT06704178|147621529|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034516|NCT06704178|147621529|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73986075|NCT01894256|147516984|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.15|||||TWO_SIDED|90.0|1.04|1.27|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.27|1.04|
73986076|NCT01894256|147516984|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.26|||||TWO_SIDED|90.0|1.06|1.48|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.48|1.06|
73986077|NCT01894256|147516985|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.24|||||TWO_SIDED|90.0|1.06|1.47|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.47|1.06|
73986078|NCT01894256|147516985|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.44|||||TWO_SIDED|90.0|1.1|1.89|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.89|1.10|
73986079|NCT00645099|147517000|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||Based on available data it was estimated that in the paliperidone ER group the TG:HDL ratio would decrease with 0.15 and that the TG:HDL ratio would increase with 0.25 in the olanzapine group. The common SD of the change was estimated to be 1.4. A sample size of 205 patients in each treatment arm had 80% power to detect a difference of 0.4 in change of TG:HDL ratio after 6 months of treatment in favor of paliperidone ER treatment (Wilcoxon two-sample test with 0.05 two-sided significance level).||||< 0.0001
73986080|NCT00645099|147517000|SUPERIORITY_OR_OTHER|||||||0.4718||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group comparison of the change from baseline at end point.||||0.4718
73986081|NCT00645099|147517000|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline at end point.||||< 0.0001
73986082|NCT00645099|147517001|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
73986083|NCT00645099|147517001|SUPERIORITY_OR_OTHER|||||||0.9143||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.9143
74034517|NCT06704178|147621529|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within group analysis only.||||||>0.9999
74089712|NCT03545191|147732308|OTHER||LS mean difference to placebo|-1.9|||=|0.0002|TWO_SIDED|95.0|-2.905|-0.905|||Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 50 mg vs placebo).||-0.905|-2.905|= 0.0002
74034518|NCT06704178|147621529|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034519|NCT06704178|147621529|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73986084|NCT00645099|147517001|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
74034520|NCT06704178|147621529|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034521|NCT06704178|147621530|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034522|NCT06704178|147621530|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034523|NCT06704178|147621530|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034524|NCT06704178|147621530|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73986085|NCT00645099|147517002|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0050
73986086|NCT00645099|147517002|SUPERIORITY_OR_OTHER|||||||0.4454||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.4454
73986087|NCT00645099|147517002|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.0018
73986088|NCT00645099|147517003|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
73986089|NCT00645099|147517004|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0004
73986090|NCT00645099|147517005|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0272
73986091|NCT00645099|147517006|SUPERIORITY_OR_OTHER|||||||0.1892||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1892
73986092|NCT00645099|147517007|SUPERIORITY_OR_OTHER|||||||0.0325||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0325
73986093|NCT00645099|147517008|SUPERIORITY_OR_OTHER|||||||0.1117||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1117
73986094|NCT00645099|147517009|SUPERIORITY_OR_OTHER|||||||0.6346||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.6346
73986095|NCT00645099|147517010|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||1.0000
73986096|NCT00645099|147517011|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.6770
73986097|NCT00645099|147517012|SUPERIORITY_OR_OTHER|||||||0.1308||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1308
74034525|NCT06704178|147621530|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034526|NCT06704178|147621530|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034527|NCT06704178|147621531|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034528|NCT06704178|147621531|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034529|NCT06704178|147621531|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034530|NCT06704178|147621531|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73956396|NCT01879371|147448699|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|109.48|||||TWO_SIDED|90.0|107.072|111.936|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||111.936|107.072|
74034531|NCT06704178|147621531|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73956397|NCT01879371|147448700|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|99.65|||||TWO_SIDED|90.0|93.874|105.776|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||105.776|93.874|
73956398|NCT01879371|147448700|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|70.42|||||TWO_SIDED|90.0|67.087|73.928|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||73.928|67.087|
73956399|NCT01879371|147448701|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|106.5|||||TWO_SIDED|90.0|104.05|109.004|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||109.004|104.050|
73956400|NCT01879371|147448701|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|108.59|||||TWO_SIDED|90.0|106.185|111.054|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||111.054|106.185|
73986098|NCT00645099|147517013|SUPERIORITY_OR_OTHER|||||||0.3358||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.3358
73986099|NCT00645099|147517014|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
73986100|NCT00645099|147517014|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.0001
73986101|NCT00645099|147517014|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||< 0.0001
73986102|NCT00645099|147517015|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
73986103|NCT00645099|147517016|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
73986104|NCT00645099|147517017|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.0230
73986105|NCT00645099|147517018|NON_INFERIORITY_OR_EQUIVALENCE|Testing non-inferiority of the paliperidone ER treatment group compared to the olanzapine treatment group, with regard to change versus baseline at end point of the total PANSS was done by means of Schuirmann's test. A difference of 6 points in change versus baseline on the total PANSS was considered to be a minimum clinically relevant difference.The null hypothesis is that there is no difference between paliperidone and olanzapine in change in TG:HDL ratio from baseline to endpoint.||||||0.0242||95.0|||||Schuirmann|The null hypothesis of non-equivalence was rejected and equivalence to within the specified equivalence bounds could be claimed.||||||0.0242
73986106|NCT00645099|147517018|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
73986107|NCT00645099|147517018|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
73986108|NCT01201915|147517019|SUPERIORITY_OR_OTHER|||||||0.8463|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.||||0.8463
73986109|NCT01201915|147517019|SUPERIORITY_OR_OTHER|||||||0.9668|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 30% or less.||||0.9668
73986110|NCT01201915|147517019|SUPERIORITY_OR_OTHER|||||||0.7878|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.||||0.7878
73875115|NCT00428948|147291792|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.7532|TWO_SIDED|95.0|0.602|2.017|||Cochran-Mantel-Haenszel||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the percentage of participants with a clinically sustained decrease of blood pressure leading to a sustained reduction in antihypertensive therapy between the tolvaptan group and the placebo group.||2.017|0.602|0.7532
73956401|NCT00580801|147448714|SUPERIORITY_OR_OTHER||Least square mean ratio|0.98||||||90.0|0.54|1.78|||||Day 1: The least square (LS) means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.78|0.54|
74034532|NCT06704178|147621531|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875116|NCT02784171|147291845|SUPERIORITY|||||||0.0372|||||||Log Rank|||||||0.0372
73875117|NCT00369577|147291856|SUPERIORITY|||||||0.088||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||0.0880
73875118|NCT00369577|147291856|SUPERIORITY|||||||0.0002||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||0.0002
73875119|NCT00369577|147291857|SUPERIORITY|||||||0.0583|||||||Wilcoxon (Mann-Whitney)|||||||0.0583
73875120|NCT00369577|147291857|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
73956402|NCT00580801|147448714|SUPERIORITY_OR_OTHER||Least square mean ratio|1.33||||||90.0|1.03|1.72|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.72|1.03|
73956403|NCT00580801|147448715|SUPERIORITY_OR_OTHER||Least square mean ratio|1.0||||||90.0|0.58|1.72|||||Day 1: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.72|0.58|
73956404|NCT00580801|147448715|SUPERIORITY_OR_OTHER||Least square mean ratio|1.32||||||90.0|1.05|1.66|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.66|1.05|
73956405|NCT00580801|147448716|SUPERIORITY_OR_OTHER||Least square mean ratio|1.43||||||90.0|1.02|2.02|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||2.02|1.02|
73956406|NCT00580801|147448717|SUPERIORITY_OR_OTHER||Least square mean ratio|1.24||||||90.0|0.88|1.74|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.74|0.88|
73956407|NCT01664104|147448823|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
73956408|NCT01664104|147448823|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
73956409|NCT01664104|147448824|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
73956410|NCT01664104|147448824|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.||||||<0.0001
73956411|NCT01664104|147448825|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 3.||||||<0.0001
73956412|NCT01664104|147448825|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.||||||<0.0001
73956413|NCT01664104|147448845|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
73956414|NCT01664104|147448845|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
73956415|NCT01664104|147448846|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
73956416|NCT01664104|147448846|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
73956417|NCT01664104|147448847|SUPERIORITY_OR_OTHER|||||||0.6904|||||||t-test|P-value signifies CRP at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).||||||0.6904
73956418|NCT01664104|147448847|SUPERIORITY_OR_OTHER|||||||0.6032|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using SDAI (remission versus no remission).||||||0.6032
73956419|NCT01664104|147448847|SUPERIORITY_OR_OTHER|||||||0.6146|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using CDAI (remission versus no remission).||||||0.6146
73956420|NCT01664104|147448848|SUPERIORITY_OR_OTHER|||||||0.0018|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).||||||0.0018
73956421|NCT01664104|147448848|SUPERIORITY_OR_OTHER|||||||0.1617|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using SDAI (remission versus no remission).||||||0.1617
73956422|NCT01664104|147448848|SUPERIORITY_OR_OTHER|||||||0.1296|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using CDAI (remission versus no remission).||||||0.1296
73956423|NCT01664104|147448851|SUPERIORITY_OR_OTHER|||||||0.5332|||||||t-test|P-value signifies the CRP at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus \> 30 minutes).||||||0.5332
73956424|NCT01664104|147448852|SUPERIORITY_OR_OTHER|||||||0.6159|||||||t-test|P-value signifies the BMI at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus \> 30 minutes).||||||0.6159
73956425|NCT01664104|147448853|SUPERIORITY_OR_OTHER|||||||0.237|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.2370
73956426|NCT01664104|147448853|SUPERIORITY_OR_OTHER|||||||0.8033|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus HAQ-D1 (0-3) at Month 6.||||||0.8033
73956427|NCT01664104|147448854|SUPERIORITY_OR_OTHER|||||||0.0306|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.||||||0.0306
74034533|NCT06704178|147621532|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875121|NCT00369577|147291858|SUPERIORITY|||||||0.0067|||||||Wilcoxon (Mann-Whitney)|||||||0.0067
73875122|NCT00369577|147291858|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
73875123|NCT00369577|147291859|SUPERIORITY|||||||0.0076|||||||Fisher Exact|||||||0.0076
73986111|NCT03859622|147517023|OTHER|Frequencies and percentages for categorical data.||||||||||||Standard methods are used for the description of data (frequencies and percentages for categorical data)||||Standard methods are used for the description of data (frequencies and percentages for categorical data)|Standard methods are used for the description of data (frequencies and percentages for categorical data)|||
73986112|NCT01524887|147517030|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.4||||0.243||95.0|-1.0|3.9|||Mixed Models Analysis|||||3.9|-1.0|0.243
73986113|NCT01524887|147517030|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.0||||0.37||95.0|-1.2|3.3|||Mixed Models Analysis|||||3.3|-1.2|0.370
73986114|NCT01524887|147517031|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-3.9||||0.033||95.0|-7.4|-0.3|||Mixed Models Analysis|||||-0.3|-7.4|0.033
73986115|NCT01524887|147517031|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.9||||0.586||95.0|-4.2|2.4|||Mixed Models Analysis|||||2.4|-4.2|0.586
74034534|NCT06704178|147621532|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034535|NCT06704178|147621532|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034536|NCT06704178|147621532|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034537|NCT06704178|147621532|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034538|NCT06704178|147621532|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875124|NCT00369577|147291859|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
73875125|NCT01059318|147291880|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|76.0|||||TWO_SIDED|95.0|-45.0|196.0|||Bayesian analysis|A Bayesian posterior distribution of the treatment effect at 26 weeks was evaluated using a non-informative prior.|MILES study and current study had different study designs, so change from baseline to 26 weeks in MILES study was estimated from the publicly reported rate of change per month in order to provide a meaningful comparison based on Bayesian analysis.|"Proof of Concept was proposed as follows:~* 90% level of proof that difference in FVC change from baseline everolimus vs. Historical Placebo Control arm from MILES study \> 0 mL~* 50% level of proof that difference in FVC change from baseline everolimus vs. Historical Placebo Control arm from MILES study \>= 100 mL~Historical data from 43 patients treated with placebo from the MILES study were down weighted to an effective sample size of 18 for comparison."||196|-45|
73875126|NCT01059318|147291881|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|186.0|||||TWO_SIDED|95.0|93.0|279.0|||Bayesian analysis|A Bayesian posterior distribution of the treatment effect at 26 weeks was evaluated using a non-informative prior.|MILES study and current study had different study designs, so change from baseline to 26 weeks in MILES study was estimated from the publicly reported rate of change per month in order to provide a meaningful comparison based on Bayesian analysis.|"Proof of Concept was proposed as follows:~* 90% level of proof that difference in FEV1 change from baseline everolimus vs. Historical Placebo Control arm from MILES study \> 0 mL~* 50% level of proof that difference in FEV1 change from baseline everolimus vs. Historical Placebo Control arm from MILES study \>= 100 mL~Historical data from 43 patients treated with placebo from the MILES study were down weighted to an effective sample size of 18 for comparison."||279|93|
73875127|NCT00824473|147291945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4286|STANDARD_ERROR_OF_MEAN|0.351|<|0.001||95.0|-2.12|-0.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline||-0.74|-2.12|<0.001
73986116|NCT01524887|147517032|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.2||||0.501||95.0|-1.0|0.5|||Mixed Models Analysis|||||0.5|-1.0|0.501
73986117|NCT01524887|147517032|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.1||||0.783||95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.783
73986118|NCT01524887|147517033|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.1||||0.571||95.0|-2.6|4.7|||Mixed Models Analysis|||||4.7|-2.6|0.571
73986119|NCT01524887|147517033|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|3.7||||0.032||95.0|0.3|7.1|||Mixed Models Analysis|||||7.1|0.3|0.032
73986120|NCT01524887|147517034|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.00026||||0.593||95.0|-0.00126|0.00073|||ANCOVA|||||0.00073|-0.00126|0.593
73986121|NCT01524887|147517034|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|0.00003||||0.94||95.0|-0.0008|0.00086|||ANCOVA|||||0.00086|-0.00080|0.940
73986122|NCT01524887|147517035|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.5||||0.633||95.0|-2.8|1.7|||Mixed Models Analysis|||||1.7|-2.8|0.633
73986123|NCT01524887|147517035|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|0.0||||0.981||95.0|-2.0|2.0|||Mixed Models Analysis|||||2.0|-2.0|0.981
73986124|NCT00088452|147517092|SUPERIORITY||Odds Ratio (OR)|2.66|||<|0.001|TWO_SIDED|95.0|1.65|4.28|||Chi-squared||odds ratio with ethosuximide vs. lamotrigine|Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.||4.28|1.65|<0.001
74034539|NCT06704178|147621533|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034540|NCT06704178|147621533|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034541|NCT06704178|147621533|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034542|NCT06704178|147621533|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034543|NCT06704178|147621533|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034544|NCT06704178|147621533|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034545|NCT06704178|147621534|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875128|NCT00824473|147291946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6063|STANDARD_ERROR_OF_MEAN|0.1697|<|0.001||95.0|-0.94|-0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.27|-0.94|<0.001
73875129|NCT00824473|147291947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3947|STANDARD_ERROR_OF_MEAN|0.3391|<|0.001||95.0|-2.06|-0.73|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline||-0.73|-2.06|<0.001
73875130|NCT00824473|147291948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9284|STANDARD_ERROR_OF_MEAN|0.2741|<|0.001||95.0|-1.47|-0.39|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||reflective TOSS change in baseline||-0.39|-1.47|<0.001
73875131|NCT00824473|147291949|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||change from baseline||||0.010
74034546|NCT06704178|147621534|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034547|NCT06704178|147621534|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034548|NCT06704178|147621534|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034549|NCT06704178|147621534|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034550|NCT06704178|147621534|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875132|NCT02109640|147292072|SUPERIORITY_OR_OTHER||Absolute percentage difference|17.1||||0.264|TWO_SIDED|95.0|-10.0|40.7||Absolute % difference 17.1 (95% CI -10.0,40.7)|Fisher Exact|||||40.7|-10.0|0.264
73875133|NCT02109640|147292073|SUPERIORITY_OR_OTHER|||||||0.222|||||||t-test, 2 sided|||||||0.222
73875134|NCT02109640|147292074|SUPERIORITY_OR_OTHER|||||||0.676|||||||t-test, 2 sided|||||||0.676
73875135|NCT03507036|147292089|OTHER||||||||||||||||||A paired t-test was performed for skin lab measurement and biopsies.|||
73875136|NCT00104650|147292109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.28|||<|0.001||95.0|3.35|45.03|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor||||45.03|3.35|<0.001
73875137|NCT00104650|147292109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.33||||0.002||95.0|1.74|16.36|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor||||16.36|1.74|0.002
73875138|NCT00104650|147292109|SUPERIORITY_OR_OTHER||Percentage of participants|77.8||||||95.0|60.8|89.9||||||||89.9|60.8|
73875139|NCT00104650|147292109|SUPERIORITY_OR_OTHER||Percentage of participants|63.6||||||95.0|45.1|79.6||||||||79.6|45.1|
73875140|NCT00104650|147292109|SUPERIORITY_OR_OTHER||Percentage of participants|28.6||||||95.0|14.6|46.3||||||||46.3|14.6|
73875141|NCT00104650|147292110|SUPERIORITY_OR_OTHER||Percentage of participants|63.9||||||95.0|46.2|79.2||||||||79.2|46.2|
73875142|NCT00104650|147292110|SUPERIORITY_OR_OTHER||Percentage of participants|63.6||||||95.0|45.1|79.6||||||||79.6|45.1|
73875143|NCT00104650|147292110|SUPERIORITY_OR_OTHER||Percentage of participants|37.1||||||95.0|21.5|55.1||||||||55.1|21.5|
73875144|NCT00104650|147292111|SUPERIORITY_OR_OTHER|||||||0.388|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)||||||0.388
73875145|NCT00104650|147292112|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.79|||<|0.001||95.0|2.01|7.15|||Regression, Cox|Stratified by cancer type and screening uNTx level||||7.15|2.01|<0.001
73875146|NCT00104650|147292112|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.32|||<|0.001||95.0|2.23|8.36|||Regression, Cox|Stratified by cancer type and screening uNTx level||||8.36|2.23|<0.001
73875147|NCT00104650|147292113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.274||||0.006||95.0|0.11|0.687|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level||||0.687|0.110|0.006
73875148|NCT00104650|147292113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.199||||0.001||95.0|0.076|0.523|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level||||0.523|0.076|0.001
73956428|NCT01664104|147448854|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.||||||0.0749
73956429|NCT01664104|147448855|SUPERIORITY_OR_OTHER|||||||0.4854|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.4854
73956430|NCT01664104|147448855|SUPERIORITY_OR_OTHER|||||||0.325|||||||S|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.3250
73956431|NCT01664104|147448856|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.||||||0.0011
74034551|NCT06704178|147621535|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034552|NCT06704178|147621535|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034553|NCT06704178|147621535|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034554|NCT06704178|147621535|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034555|NCT06704178|147621535|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034556|NCT06704178|147621535|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034557|NCT06704178|147621536|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034558|NCT06704178|147621536|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034559|NCT06704178|147621536|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034560|NCT06704178|147621536|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034561|NCT06704178|147621536|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73986125|NCT00088452|147517092|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.06|5.42|||Chi-squared||odds ratio with valproic acid vs. lamotrigine|Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.||5.42|2.06|<0.001
73986126|NCT00088452|147517093|SUPERIORITY||Odds Ratio (OR)|1.95||||0.03|TWO_SIDED|95.0|1.12|3.41|||Chi-squared||Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the ethosuximide group|||3.41|1.12|0.03
73986127|NCT00088452|147517093|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.001|TWO_SIDED|95.0|1.69|5.49|||Chi-squared||Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the lamotrigine group|||5.49|1.69|<0.001
73986128|NCT00088452|147517094|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.81|5.33|||Fisher Exact||Odds ratio for FFF for ethosuximide versus lamotrigine|||5.33|1.81|<0.001
73986129|NCT00088452|147517094|SUPERIORITY||Odds Ratio (OR)|2.88|||<|0.001|TWO_SIDED|95.0|1.68|5.02|||Fisher Exact||odds ratio for FFF for valproic acid versus lamotrigine|||5.02|1.68|<0.001
73986130|NCT02081196|147517101|OTHER||Mean Difference (Net)|4.13|STANDARD_DEVIATION|2.45|||TWO_SIDED|95.0|3.08|4.77|||||Treatment Effect =Control Flank Change-Treated Flank Change such (a positive results indicates treated area had a larger reduction in fat thickness than control area, and a negative result indicates that a greater reduction was seen in control area).|H0: μ(Control - Treated) \< +1 versus H1: μ(Control - Treated) \> +1||4.77|3.08|
73986131|NCT02081196|147517102|OTHER||sucess proportion|0.8476|||||TWO_SIDED|95.0|0.784|0.913|||||||Descriptive statistics (tabulation of Independent Panel Reviewer ratings) were used to analyze data.|.913|.784|
73986132|NCT02329223|147517128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7|STANDARD_ERROR_OF_MEAN|0.815|<|0.001|TWO_SIDED|95.0|-5.31|-2.098|||Mixed Model with repeated measures(MMRM)|||||-2.098|-5.310|<0.001
73986133|NCT02329223|147517128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.29|STANDARD_ERROR_OF_MEAN|0.828||0.006|TWO_SIDED|95.0|-3.921|-0.654|||Mixed Model with repeated measures(MMRM)|||||-0.654|-3.921|0.006
73986134|NCT03449134|147517139|OTHER||Estimated Percent Change Difference|-18.45||||0.041|TWO_SIDED|95.0|-32.92|-0.86||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||-0.86|-32.92|0.041
73986135|NCT03449134|147517139|OTHER||Estimated Percent Change Difference|1.56||||0.874|TWO_SIDED|95.0|-16.13|22.99||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||22.99|-16.13|0.874
73986136|NCT03449134|147517142|OTHER||Estimated Percent Change Difference|-17.68||||0.056|TWO_SIDED|95.0|-32.57|0.5||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||0.50|-32.57|0.056
74034562|NCT06704178|147621536|SUPERIORITY|||||||0.982||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.982
74034563|NCT06704178|147621537|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73986137|NCT03449134|147517142|OTHER||Estimated Percent Change Difference|2.95||||0.77|TWO_SIDED|95.0|-15.33|25.19||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||25.19|-15.33|0.770
73875149|NCT00104650|147292114|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)||||||0.056
73875150|NCT00104650|147292115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.162||||0.105||95.0|0.018|1.465|||Regression, Cox|||||1.465|0.018|0.105
74034564|NCT06704178|147621537|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034565|NCT06704178|147621537|SUPERIORITY||||||>|0.9999||||||Month 3 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034566|NCT06704178|147621537|SUPERIORITY||||||>|0.9999||||||Month 4 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034567|NCT06704178|147621537|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034568|NCT06704178|147621537|SUPERIORITY||||||>|0.9999||||||Month 6 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73875151|NCT00104650|147292115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.43||95.0|0.143|2.289|||Regression, Cox|||||2.289|0.143|0.430
73875152|NCT00104650|147292116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||||95.0|0.05|1.44||||||||1.44|0.05|
74034569|NCT06704178|147621538|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73986138|NCT03449134|147517143|OTHER||Odds Ratio (OR)|1.2||||0.416|TWO_SIDED|95.0|0.77|1.86|||Regression, Logistic|||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.86|0.77|0.416
74034570|NCT06704178|147621538|SUPERIORITY|||||||0.9951||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9951
74034571|NCT06704178|147621538|SUPERIORITY|||||||0.999||||||Month 3 versus Baseline|t-test, 2 sided|Within-group analysis only.||||||0.999
74089713|NCT03545191|147732309|OTHER||LSGM ratio to placebo|0.79||||0.0003|TWO_SIDED|95.0|0.7|0.9||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||0.90|0.70|0.0003
73986139|NCT03449134|147517143|OTHER||Odds Ratio (OR)|1.01||||0.948|TWO_SIDED|95.0|0.66|1.55|||Regression, Logistic|||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.55|0.66|0.948
73986140|NCT03449134|147517144|OTHER||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.94|2.05||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.05|0.94|
73986141|NCT03449134|147517144|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|1.01|2.18||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.18|1.01|
73986142|NCT03449134|147517145|OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|1.11|2.54||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.54|1.11|
73986143|NCT03449134|147517145|OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|1.01|2.3||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.30|1.01|
73986144|NCT03449134|147517146|OTHER||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|1.03|2.3||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.30|1.03|
73986145|NCT03449134|147517146|OTHER||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.86|1.89||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.89|0.86|
73986146|NCT03449134|147517147|OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.85|1.98||||||Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.98|0.85|
73986147|NCT03449134|147517147|OTHER||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.92|2.12||||||Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.12|0.92|
73986148|NCT01580995|147517169|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
74034572|NCT06704178|147621538|SUPERIORITY|||||||0.9913||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9913
74034573|NCT06704178|147621538|SUPERIORITY|||||||0.4517||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4517
74034574|NCT06704178|147621538|SUPERIORITY|||||||0.8187||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8187
74034575|NCT06704178|147621539|SUPERIORITY|||||||0.998||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.998
74034576|NCT06704178|147621539|SUPERIORITY|||||||0.9591||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9591
73986149|NCT00821119|147517219|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED|95.0|0.48|1.14|||risk ratio (RR)|||"Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.~The analysis was performed according to the intention-to-treat principle."||1.14|0.48|<0.05
73986150|NCT00821119|147517220|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|STANDARD_ERROR_OF_MEAN|0.16||0.05|TWO_SIDED|95.0|0.48|1.14|||risk ratio (RR)|||Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.||1.14|0.48|0.05
73986151|NCT00821119|147517221|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|0.62|1.78|||risk ratio (RR)|||The study was not powered for this outcome. However this analysis was done with this limitation||1.78|0.62|< 0.05
73986152|NCT01697592|147517245|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.93|||<|0.001|TWO_SIDED|95.0|-1.1|-0.75|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.75|-1.10|<0.001
73986153|NCT01697592|147517245|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.37|-0.6|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.60|-1.37|<0.001
74034577|NCT06704178|147621539|SUPERIORITY|||||||0.9994||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9994
74034578|NCT06704178|147621539|SUPERIORITY|||||||0.9936||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9936
74034579|NCT06704178|147621539|SUPERIORITY|||||||0.8526||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8526
73875153|NCT00104650|147292116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||||95.0|0.08|1.76||||||||1.76|0.08|
73986154|NCT01697592|147517245|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.92|||<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.56|-1.29|<0.001
73986155|NCT01697592|147517245|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.45|-0.88|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.88|-1.45|<0.001
73986156|NCT01697592|147517245|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.8|||<|0.001|TWO_SIDED|95.0|-1.06|-0.54|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.54|-1.06|<0.001
73986157|NCT01212952|147517275|OTHER||Maximum Tolerated Dose (MTD) (mg/m^2)|1.3|||||TWO_SIDED||||||||Maximum Tolerated Dose Level is Dose Level 2 (1.3 mg/m\^2 Bortezomib).|||||
73986158|NCT02253147|147517297|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA UD and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.34|-0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 95.0% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Ultra Deep versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."||-0.11|-0.34|
73986159|NCT02621047|147517321|SUPERIORITY_OR_OTHER||Geometric Mean Ratio Percentage (%)|128.0|||||TWO_SIDED|90.0|86.5|188.0||||||||188|86.5|
73986160|NCT02621047|147517321|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|100.0|||||TWO_SIDED|90.0|55.1|183.0||||||||183|55.1|
73986161|NCT02621047|147517322|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|148.0|||||TWO_SIDED|90.0|106.0|208.0||||||||208|106|
73986162|NCT02621047|147517322|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|130.0|||||TWO_SIDED|90.0|75.4|225.0||||||||225|75.4|
73986163|NCT02621047|147517323|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|160.0||||||90.0|105.0|243.0||||||||243|105|
73986164|NCT02621047|147517323|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|220.0||||||90.0|131.0|369.0||||||||369|131|
74034580|NCT06704178|147621539|SUPERIORITY|||||||0.4375||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4375
74034581|NCT06704178|147621540|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034582|NCT06704178|147621540|SUPERIORITY|||||||0.7477||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||0.7477
74034583|NCT06704178|147621540|SUPERIORITY|||||||0.297||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.297
74034584|NCT06704178|147621540|SUPERIORITY|||||||0.3503||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3503
74034585|NCT06704178|147621540|SUPERIORITY|||||||0.297||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.297
74034586|NCT06704178|147621540|SUPERIORITY|||||||0.4449||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4449
73986165|NCT02621047|147517324|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|186.0||||||90.0|122.0|281.0||||||||281|122|
73986166|NCT02621047|147517324|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|285.0||||||90.0|175.0|466.0||||||||466|175|
73986167|NCT02621047|147517325|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|162.0|||||TWO_SIDED|90.0|104.0|254.0||||||||254|104|
73986168|NCT02621047|147517325|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|228.0||||||90.0|129.0|403.0||||||||403|129|
73986169|NCT02621047|147517326|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|189.0||||||90.0|121.0|293.0||||||||293|121|
73986170|NCT02621047|147517326|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|296.0|||||TWO_SIDED|90.0|174.0|506.0||||||||506|174|
73986171|NCT02621047|147517327|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|64.6||||||90.0|36.2|115.0||||||||115|36.2|
73986172|NCT02621047|147517327|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|60.8|||||TWO_SIDED|90.0|26.6|139.0||||||||139|26.6|
73986173|NCT02621047|147517328|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|85.1||||||90.0|55.5|130.0||||||||130|55.5|
73986174|NCT02621047|147517328|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|59.0||||||90.0|34.2|102.0||||||||102|34.2|
73986175|NCT02621047|147517329|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|116.0||||||90.0|78.6|172.0||||||||172|78.6|
73986176|NCT02621047|147517329|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|98.1||||||90.0|51.7|186.0||||||||186|51.7|
73986177|NCT02621047|147517330|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|115.0|||||TWO_SIDED|90.0|85.2|154.0||||||||154|85.2|
73986178|NCT02621047|147517330|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|96.6|||||TWO_SIDED|90.0|55.6|168.0||||||||168|55.6|
73986179|NCT02621047|147517331|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|80.6||||||90.0|50.2|130.0||||||||130|50.2|
73986180|NCT02621047|147517331|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|65.6|||||TWO_SIDED|90.0|26.9|160.0||||||||160|26.9|
73986181|NCT02621047|147517332|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|104.0||||||90.0|76.8|141.0||||||||141|76.8|
73986182|NCT02621047|147517332|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|63.7|||||TWO_SIDED|90.0|34.0|119.0||||||||119|34.0|
73986183|NCT02621047|147517333|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|136.0|||||TWO_SIDED|90.0|94.7|196.0||||||||196|94.7|
74034587|NCT06704178|147621541|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034588|NCT06704178|147621541|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
73986184|NCT02621047|147517333|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|176.0||||||90.0|98.4|315.0||||||||315|98.4|
74034589|NCT06704178|147621541|SUPERIORITY|||||||0.9188||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9188
73986185|NCT02621047|147517334|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|134.0||||||90.0|99.6|181.0||||||||181|99.6|
73986186|NCT02621047|147517334|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|157.0|||||TWO_SIDED|90.0|91.8|268.0||||||||268|91.8|
73986187|NCT02621047|147517335|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|73.3|||||TWO_SIDED|90.0|46.2|116.0||||||||116|46.2|
73986188|NCT02621047|147517335|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|57.5|||||TWO_SIDED|90.0|20.0|165.0||||||||165|20.0|
73986189|NCT02621047|147517336|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|96.6||||||90.0|69.9|134.0||||||||134|69.9|
73986190|NCT02621047|147517336|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|55.8||||||90.0|26.0|120.0||||||||120|26.0|
73986191|NCT02621047|147517337|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|139.0|||||TWO_SIDED|90.0|94.8|203.0||||||||203|94.8|
73986192|NCT02621047|147517337|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|180.0||||||90.0|97.2|334.0||||||||334|97.2|
73986193|NCT02621047|147517338|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|137.0|||||TWO_SIDED|90.0|100.0|186.0||||||||186|100|
73986194|NCT02621047|147517338|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|158.0|||||TWO_SIDED|90.0|91.2|274.0||||||||274|91.2|
73986195|NCT02236598|147517358|SUPERIORITY|||||||0.5582|||||||ANCOVA|||||||0.5582
73986196|NCT02236598|147517359|SUPERIORITY|Change in Fasting Glucose||||||0.0963|||||||ANCOVA|||||||0.0963
73986197|NCT02236598|147517359|SUPERIORITY|Change in 1-hour Glucose||||||0.6671|||||||ANCOVA|||||||0.6671
73986198|NCT02236598|147517359|SUPERIORITY|Change in 2-hour Glucose||||||0.7913|||||||ANCOVA|||||||0.7913
73986199|NCT02236598|147517360|SUPERIORITY|||||||0.5294|||||||ANCOVA|||||||0.5294
73986200|NCT02236598|147517361|SUPERIORITY|||||||0.1604|||||||ANCOVA|||||||0.1604
74034590|NCT06704178|147621541|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034591|NCT06704178|147621541|SUPERIORITY|||||||0.3503||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3503
74034592|NCT06704178|147621541|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
74034593|NCT00488618|147621542|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.1|||<|0.0001|TWO_SIDED|95.0|-8.9|-3.3|||ANCOVA||cariprazine - placebo|||-3.3|-8.9|<0.0001
74034594|NCT00488618|147621543|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64||||0.0001|TWO_SIDED|95.0|-0.97|-0.32|||ANCOVA||cariprazine - placebo|||-0.32|-0.97|0.0001
73986201|NCT03544229|147517378|SUPERIORITY||Least Square Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.25|=|0.618|TWO_SIDED|90.0|-0.34|0.49||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.49|-0.34|=0.618
73986202|NCT03544229|147517378|SUPERIORITY||Least Square Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17|=|0.533|TWO_SIDED|90.0|-0.27|0.29||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.29|-0.27|=0.533
73986203|NCT03544229|147517378|SUPERIORITY||Least Square Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.167|=|0.447|TWO_SIDED|90.0|-0.3|0.25||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.25|-0.30|=0.447
73986204|NCT03544229|147517379|SUPERIORITY||Odds Ratio (OR)|0.87|||=|0.607|TWO_SIDED|90.0|0.39|1.96|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||1.96|0.39|=0.607
73986205|NCT03544229|147517379|SUPERIORITY||Odds Ratio (OR)|1.21|||=|0.283|TWO_SIDED|90.0|0.7|2.1|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||2.10|0.70|=0.283
73986206|NCT03544229|147517379|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.527|TWO_SIDED|90.0|0.56|1.69|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||1.69|0.56|=0.527
73986207|NCT03544229|147517380|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.279|=|0.584|TWO_SIDED|90.0|-0.4|0.52||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.52|-0.40|=0.584
74034595|NCT00833248|147621592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.3||||0.8942|TWO_SIDED|95.0|-4.74|4.14|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||FAS. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||4.14|-4.74|0.8942
73875154|NCT00773513|147292138|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025.|Hazard Ratio (HR)|1.03||||0.0039|TWO_SIDED|95.0|0.93|1.15|||Regression, Cox||The pre-specified upper non-inferiority limit was 95% CI \<1.20.|||1.15|0.93|0.0039
73875155|NCT00773513|147292139|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|1.06||||0.0166|TWO_SIDED|95.0|0.94|1.19|||Regression, Cox|||||1.19|0.94|0.0166
73875156|NCT00773513|147292140|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.95||||0.0219|TWO_SIDED|95.0|0.76|1.19|||Regression, Cox|||||1.19|0.76|0.0219
73875157|NCT00773513|147292141|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.94||||0.0459|TWO_SIDED|95.0|0.7|1.25|||Regression, Cox|||||1.25|0.70|0.0459
73875158|NCT00773513|147292142|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.91||||0.0048|TWO_SIDED|95.0|0.74|1.12|||Regression, Cox|||||1.12|0.74|0.0048
73875159|NCT04184297|147292177|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.76|0.96|||Regression, Cox|The method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.||0.96|0.76|
73875160|NCT04184297|147292178|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.64|1.07|||Regression, Cox|This method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of a hospitalization for community-acquired pneumonia for overall population.||1.07|0.64|
73875161|NCT04184297|147292179|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19|||Regression, Cox|The method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.||1.19|0.91|
73956432|NCT01664104|147448856|SUPERIORITY_OR_OTHER|||||||0.0013|||||||Spearman Correlation|P-value calculated from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.||||||0.0013
73956433|NCT01664104|147448857|SUPERIORITY_OR_OTHER|||||||0.5655|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.5655
73956434|NCT01664104|147448857|SUPERIORITY_OR_OTHER|||||||0.3977|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.3977
73956435|NCT01664104|147448858|SUPERIORITY_OR_OTHER|||||||0.0123|||||||Pearson correlation|P-value obtained from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6.||||||0.0123
73956436|NCT01664104|147448858|SUPERIORITY_OR_OTHER|||||||0.0151|||||||Spearman Correlation|P-value obtained from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6||||||0.0151
73956437|NCT01664104|147448859|SUPERIORITY_OR_OTHER|||||||0.9909|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.9909
73956438|NCT01664104|147448859|SUPERIORITY_OR_OTHER|||||||0.6482|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.6482
73956439|NCT03068611|147448871|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||.90
73956440|NCT03068611|147448872|SUPERIORITY|||||||0.54|||||||Chi-squared|||||||.54
73956441|NCT03068611|147448873|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|Data were log-transformed transformed due to positive skewness||||||.36
73956442|NCT03068611|147448874|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|Data were log-transformed to correct positive skewness||||||.92
73956443|NCT01467700|147448929|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.28||0.518|TWO_SIDED|98.0|-2.9|3.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||3.1|-2.9|0.518
73956444|NCT01467700|147448929|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.29||0.979|TWO_SIDED|98.0|-0.4|5.7||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||5.7|-0.4|0.979
73956445|NCT01467700|147448929|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.29||0.4|TWO_SIDED|99.0|-3.7|3.0||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||3.0|-3.7|0.400
73956446|NCT01467700|147448930|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.22||0.017|TWO_SIDED|98.0|-0.5|9.9||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||9.9|-0.5|0.017
73956447|NCT01467700|147448930|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|2.25||0.361|TWO_SIDED|98.0|-4.5|6.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||6.1|-4.5|0.361
73956448|NCT01467700|147448930|SUPERIORITY_OR_OTHER||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|2.23||0.002|TWO_SIDED|99.0|0.6|12.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||12.1|0.6|0.002
73956449|NCT03727854|147448941|SUPERIORITY|||||||0.933|||||||t-test, 2 sided|||||||0.933
73956450|NCT03727854|147448942|SUPERIORITY|||||||0.971|||||||t-test, 2 sided|||||||0.971
73956451|NCT03727854|147448943|SUPERIORITY|||||||0.608|||||||t-test, 2 sided|||||||0.608
73956452|NCT03727854|147448944|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
73875162|NCT02412098|147292180|OTHER||Geometric Least Square Mean (GLSM) Ratio|73.54|||||TWO_SIDED|90.0|41.92|129.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.||129.01|41.92|
74034596|NCT00833248|147621593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.268||||0.9123|TWO_SIDED|95.0|-5.05|4.52|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||PP analysis set. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||4.52|-5.05|0.9123
74034597|NCT01826422|147621613|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
74034598|NCT01826422|147621614|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||>0.05
73875163|NCT02412098|147292180|OTHER||GLSM Ratio (%)|127.8|||||TWO_SIDED|90.0|73.57|222.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.||222.01|73.57|
73956453|NCT03727854|147448945|SUPERIORITY|||||||0.823|||||||t-test, 2 sided|||||||0.823
73956454|NCT03727854|147448946|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.740
73956455|NCT03727854|147448947|SUPERIORITY|||||||0.551|||||||t-test, 2 sided|||||||0.551
73956456|NCT03727854|147448948|SUPERIORITY|||||||0.652|||||||t-test, 2 sided|||||||0.652
73956457|NCT03727854|147448949|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||||||0.639
73956458|NCT00813488|147448963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|0.06|0.2|||Mixed effects ANOVA crossover model|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.20|0.06|0.0004
73956459|NCT00813488|147448964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.2242|TWO_SIDED|95.0|-0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.05|-0.01|0.2242
73956460|NCT00813488|147448965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.05||0.0106|TWO_SIDED|95.0|0.01|0.11||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.11|0.01|0.0106
73956461|NCT00813488|147448966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.21|0.4||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID30 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.40|.21|<0.0001
73956462|NCT00813488|147448967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|0.18|0.37||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.37|0.18|<0.0001
73956463|NCT00813488|147448968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.15||0.0002|TWO_SIDED|95.0|0.08|0.27||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.27|0.08|0.0002
73956464|NCT00813488|147448975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.5|||ANOVA|||||0.50|0.25|<0.0001
73875164|NCT02412098|147292181|OTHER||GLSM Ratio (%)|80.82|||||TWO_SIDED|90.0|45.11|144.79|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 AUCinf.||144.79|45.11|
74034599|NCT01826422|147621615|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||>0.05
74034600|NCT01826422|147621616|SUPERIORITY_OR_OTHER||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
74034601|NCT01826422|147621617|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
74034602|NCT01826422|147621618|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
73875165|NCT02412098|147292181|OTHER||GLSM Ratio (%)|73.52|||||TWO_SIDED|90.0|47.83|113.02||ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 AUCinf.|||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|||113.02|47.83|
73875166|NCT02412098|147292182|OTHER||GLSM Ratio (%)|66.55|||||TWO_SIDED|90.0|53.33|83.04|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.||83.04|53.33|
73875167|NCT02412098|147292182|OTHER||GLSM Ratio (%)|102.06|||||TWO_SIDED|90.0|83.03|125.45|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.||125.45|83.03|
73956465|NCT00813488|147448976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.0001|TWO_SIDED|95.0|0.55|1.1|||ANOVA|||||1.10|.55|<0.0001
73956466|NCT00813488|147448977|SUPERIORITY_OR_OTHER|||||||0.5575|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.5575
73956467|NCT00813488|147448978|SUPERIORITY_OR_OTHER|||||||0.0981|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0981
73956468|NCT00813488|147448979|SUPERIORITY_OR_OTHER|||||||0.0443|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0443
73956469|NCT00813488|147448980|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0004
73956470|NCT00813488|147448981|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0001
73956471|NCT00813488|147448982|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0018
73956472|NCT00813488|147448983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|0.58|0.9||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||||0.90|0.58|<0.0001
73956473|NCT00813488|147448985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1464||||0.7012|TWO_SIDED|95.0|0.6|2.3|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.3|0.6|0.7012
73956474|NCT00813488|147448986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0704||||0.6545|TWO_SIDED|95.0|0.8|1.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.8|0.6545
73956475|NCT00813488|147448987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2544||||0.0407|TWO_SIDED|95.0|1.0|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.0|0.0407
73956476|NCT00813488|147448988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5745||||0.0007|TWO_SIDED|95.0|1.2|2.0|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.0|1.2|0.0007
73956477|NCT00813488|147448989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5828||||0.0372|TWO_SIDED|95.0|1.0|2.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.4|1.0|0.0372
73956478|NCT00813488|147448990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3722||||0.3099|TWO_SIDED|95.0|0.7|2.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.5|0.7|0.3099
73956479|NCT00813488|147448991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8434||||0.5777|TWO_SIDED|95.0|0.5|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.5|.5|0.5777
73956480|NCT00813488|147448992|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986||||0.9567|TWO_SIDED|95.0|0.6|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|0.6|0.9567
73956481|NCT00813488|147448993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1366||||0.4253|TWO_SIDED|95.0|0.8|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|0.8|0.4253
73956482|NCT00813488|147448994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4269||||0.0038|TWO_SIDED|95.0|1.1|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.1|0.0038
73986208|NCT03544229|147517380|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.189|=|0.625|TWO_SIDED|90.0|-0.25|0.37||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.37|-0.25|=0.625
73986209|NCT03544229|147517380|SUPERIORITY||Least-Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.187|=|0.54|TWO_SIDED|90.0|-0.29|0.33||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.33|-0.29|=0.540
73986210|NCT03544229|147517381|SUPERIORITY||Least-Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.283|=|0.51|TWO_SIDED|90.0|-0.46|0.47||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.47|-0.46|=0.510
73986211|NCT03544229|147517381|SUPERIORITY||Least-Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.192|=|0.674|TWO_SIDED|90.0|-0.23|0.4||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.40|-0.23|=0.674
73986212|NCT03544229|147517381|SUPERIORITY||Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.189|=|0.367|TWO_SIDED|90.0|-0.38|0.25||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.25|-0.38|=0.367
73986213|NCT03544229|147517382|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.289|=|0.587|TWO_SIDED|90.0|-0.41|0.54||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.54|-0.41|=0.587
73986214|NCT03544229|147517382|SUPERIORITY||Least-Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.196|=|0.6|TWO_SIDED|90.0|-0.27|0.37||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.37|-0.27|=0.600
73986215|NCT03544229|147517382|SUPERIORITY||Least-Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.193|=|0.446|TWO_SIDED|90.0|-0.34|0.29||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.29|-0.34|=0.446
73986216|NCT03544229|147517383|SUPERIORITY||Least-Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.245|=|0.562|TWO_SIDED|90.0|-0.37|0.44||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.44|-0.37|=0.562
73986217|NCT03544229|147517383|SUPERIORITY||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.166|=|0.138|TWO_SIDED|90.0|-0.46|0.09||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.09|-0.46|=0.138
73986218|NCT03544229|147517383|SUPERIORITY||Least-Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.164|=|0.394|TWO_SIDED|90.0|-0.32|0.23||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.23|-0.32|=0.394
73986219|NCT03544229|147517384|SUPERIORITY||Least-Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.484|=|0.709|TWO_SIDED|90.0|-0.53|1.07||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||1.07|-0.53|=0.709
73986220|NCT03544229|147517384|SUPERIORITY||Least-Squares Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.332|=|0.76|TWO_SIDED|90.0|-0.31|0.78||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.78|-0.31|=0.760
73986221|NCT03544229|147517384|SUPERIORITY||Least-Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.33|=|0.591|TWO_SIDED|90.0|-0.47|0.62||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.62|-0.47|=0.591
73986222|NCT03544229|147517385|SUPERIORITY||Least-Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.27|=|0.742|TWO_SIDED|90.0|-0.27|0.62||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.62|-0.27|=0.742
73986223|NCT03544229|147517385|SUPERIORITY||Least-Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.183|=|0.461|TWO_SIDED|90.0|-0.32|0.28||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.28|-0.32|=0.461
73986224|NCT03544229|147517385|SUPERIORITY||Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.181|=|0.376|TWO_SIDED|90.0|-0.36|0.24||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.24|-0.36|=0.376
73986225|NCT03544229|147517386|SUPERIORITY||Least-Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.286|=|0.591|TWO_SIDED|90.0|-0.41|0.54||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.54|-0.41|=0.591
73986226|NCT03544229|147517386|SUPERIORITY||Least-Squares mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.193|=|0.291|TWO_SIDED|90.0|-0.43|0.21||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.21|-0.43|=0.291
74034603|NCT01826422|147621619|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
74034604|NCT01826422|147621620|SUPERIORITY_OR_OTHER||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
74034605|NCT01826422|147621621|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
74034606|NCT01826422|147621622|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||<0.05
74034607|NCT01826422|147621623|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||<0.05
74034608|NCT01826422|147621624|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||0.05
73875168|NCT02412098|147292183|OTHER||GLSM Ratio (%)|76.24|||||TWO_SIDED|90.0|50.65|114.77|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.||114.77|50.65|
74034609|NCT01826422|147621625|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
73986227|NCT03544229|147517386|SUPERIORITY||Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.191|=|0.476|TWO_SIDED|90.0|-0.33|0.3||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.30|-0.33|=0.476
73986228|NCT03544229|147517387|SUPERIORITY||Least-Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.224|=|0.675|TWO_SIDED|90.0|-0.27|0.47||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.47|-0.27|=0.675
74034610|NCT01826422|147621626|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
74034611|NCT01826422|147621627|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
74034612|NCT01826422|147621628|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
73875169|NCT02412098|147292183|OTHER||GLSM Ratio (%)|71.06|||||TWO_SIDED|90.0|44.59|113.25|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.||113.25|44.59|
73875170|NCT03089580|147292186|SUPERIORITY|Paired, Student's t-test was used to contrast the outcome variable of TBUT in the treated eye versus the sham eye from visit 1 to visit 5. The null hypothesis to be tested is one of no change from pre- to post treatment, with a Type I error probability of 0.05 for the primary outcome assessment. The pattern of change over the 4 treatment visits in these continuous variables will be assessed using mixed, linear regression. SAS version 9.4 statistical software (SAS Institute, Cary, NC) was used.||||||0.3|||||||paired t test|||The primary study outcome of pre to post change in TBUT within the treated eye and also the untreated, control eye dictated the use of a paired statistical approach to sample size estimation. Clinically relevant pre to post TBUT increase of 3 seconds with a standard deviation of 4.5 seconds was used. Type I and II error estimates used were standard for a non-pivotal study, 0.05 \& 0.20. The estimated the sample size needed detect this difference in TBUT is 27 subjects.||||0.3
73875171|NCT03089580|147292187|SUPERIORITY|The p-value results from a test of the hypothesis that the change in OSDI from visit 1 does not differ from zero. Change distributions that met normal distribution test criteria (Shapiro-Wilk p-value \>0.05) were tested with the paired Student's t-test; non-normal change distributions (at visits 2 \& 4) were tested with the non-parametric Wilcoxon signed rank test.||||||0.2026|||||||paired t test|||||||0.2026
73875172|NCT03087513|147292188|SUPERIORITY||||||<|0.01||||||In all cases of motor evoked potential changes, a P-value of 0.05 was considered significant.|Mixed Models Analysis|As the amplitude values were non-normally distributed, the Mann-Whitney U test was performed to compare the two groups.||In total, 40 patients were randomised for the study. Data from 2 patients were excluded as the crossover arm could not be completed due to intraoperative MEP change (n=1) and the equipment malfunction (n=1). The data distributions were tested for normality with the Kolmogorov-Smirnov test.||||<0.01
73986229|NCT03544229|147517387|SUPERIORITY||Least-Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.152|=|0.531|TWO_SIDED|90.0|-0.24|0.26||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.26|-0.24|=0.531
73986230|NCT03544229|147517387|SUPERIORITY||Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15|=|0.473|TWO_SIDED|90.0|-0.26|0.24||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.24|-0.26|=0.473
73986231|NCT03544229|147517388|SUPERIORITY||Least-Squares Mean Difference|-8.47|STANDARD_ERROR_OF_MEAN|9.71|=|0.192|TWO_SIDED|90.0|-24.5|7.57||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 -Placebo) in symptomatic weeks was \<0.|ANOVA|||||7.57|-24.50|=0.192
73986232|NCT03544229|147517388|SUPERIORITY||Least-Squares Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|6.736|=|0.236|TWO_SIDED|90.0|-15.98|6.27||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in symptomatic weeks was \<0.|ANOVA|||||6.27|-15.98|=0.236
73986233|NCT03544229|147517388|SUPERIORITY||Least-Squares Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|6.689|=|0.297|TWO_SIDED|90.0|-14.62|7.47||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in symptomatic weeks was \<0.|ANOVA|||||7.47|-14.62|=0.297
73986234|NCT03544229|147517389|SUPERIORITY||Least-Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.3|=|0.601|TWO_SIDED|90.0|-0.42|0.57||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.57|-0.42|=0.601
73986235|NCT03544229|147517389|SUPERIORITY||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2|=|0.181|TWO_SIDED|90.0|-0.51|0.15||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model includes week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.15|-0.51|=0.181
74034613|NCT01826422|147621629|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
73875173|NCT04170543|147292193|OTHER||LS Mean Difference in Percent Change|-2.85||||0.8338|TWO_SIDED|90.0|-22.61|21.94||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||21.94|-22.61|0.8338
73875174|NCT04170543|147292193|OTHER||LS Mean Difference in Percent Change|-19.52||||0.1169|TWO_SIDED|90.0|-35.92|1.07||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||1.07|-35.92|0.1169
73875175|NCT04170543|147292193|OTHER||LS Mean Difference in Percent Change|-17.47||||0.1774|TWO_SIDED|90.0|-34.71|4.32||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||4.32|-34.71|0.1774
73875176|NCT04170543|147292193|OTHER||LS Mean Difference in Percent Change|-7.22||||0.5379|TWO_SIDED|90.0|-24.05|13.35||Unadjusted two-sided p-value|MMRM|||||13.35|-24.05|0.5379
73875177|NCT04170543|147292194|OTHER||LS Mean Difference in Percent Change|-13.02||||0.1929|TWO_SIDED|90.0|-27.08|3.75||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||3.75|-27.08|0.1929
73875178|NCT04170543|147292194|OTHER||LS Mean Difference in Percent Change|-25.71||||0.0062|TWO_SIDED|90.0|-37.83|-11.22||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||-11.22|-37.83|0.0062
73875179|NCT04170543|147292194|OTHER||LS Mean Difference in Percent Change|-18.2||||0.0705|TWO_SIDED|90.0|-31.86|-1.81||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||-1.81|-31.86|0.0705
74034614|NCT01826422|147621630|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||0.05
74034615|NCT01826422|147621631|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||0.05
74034616|NCT01826422|147621632|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||0.05
74034617|NCT03439748|147621643|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||.002
73875180|NCT04170543|147292194|OTHER||LS Mean Difference in Percent Change|-15.56||||0.0764|TWO_SIDED|90.0|-27.82|-1.21||Unadjusted two-sided p-value|MMRM|||||-1.21|-27.82|0.0764
73986236|NCT03544229|147517389|SUPERIORITY||Least-Squares Mean Diferrence|-0.24|STANDARD_ERROR_OF_MEAN|0.196|=|0.114|TWO_SIDED|90.0|-0.56|0.09||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model includes week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.09|-0.56|=0.114
73986237|NCT01061775|147517400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.05
73986238|NCT01061775|147517401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
73986239|NCT01061775|147517402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
74034618|NCT03439748|147621644|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||>.05
74034619|NCT03439748|147621645|SUPERIORITY|||||||0.024||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||.024
74034620|NCT03439748|147621649|SUPERIORITY|||||||0.922||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.922
74089714|NCT03545191|147732309|OTHER||LSGM ratio to placebo|0.73|||<|0.0001|TWO_SIDED|95.0|0.65|0.82||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 50 mg vs placebo).||0.82|0.65|<0.0001
73875181|NCT04170543|147292195|OTHER||LS Mean Difference in Percent Change|7.25||||0.5474|TWO_SIDED|90.0|-11.45|29.88||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||29.88|-11.45|0.5474
73986240|NCT01061775|147517403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
73986241|NCT03303521|147517404|SUPERIORITY||Odds Ratio (OR)|68.77|||<|0.001|TWO_SIDED|95.0|10.85|2810.85|||Fisher Exact|||||2810.85|10.85|<0.001
73986242|NCT03303521|147517406|SUPERIORITY||Odds Ratio (OR)|35.51|||<|0.001|TWO_SIDED|95.0|8.53|309.48|||Fisher Exact|||||309.48|8.53|<0.001
74034621|NCT03439748|147621650|SUPERIORITY|||||||0.049||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.049
74034622|NCT03439748|147621651|SUPERIORITY|||||||0.591||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.591
73986243|NCT02642159|147517407|SUPERIORITY||LS Mean Difference|-32.5|||<|0.0001|TWO_SIDED|97.5|-38.1|-27.0||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Alirocumab group was compared to usual care group using an appropriate contrast statement.||-27.0|-38.1|<0.0001
74034623|NCT03439748|147621652|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.004
73875182|NCT04170543|147292195|OTHER||LS Mean Difference in Percent Change|3.11||||0.792|TWO_SIDED|90.0|-14.83|24.82||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||24.82|-14.83|0.7920
73875183|NCT04170543|147292195|OTHER||LS Mean Difference in Percent Change|-3.4||||0.7711|TWO_SIDED|90.0|-20.59|17.51||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||17.51|-20.59|0.7711
73875184|NCT04170543|147292195|OTHER||LS Mean Difference in Percent Change|5.27||||0.6163|TWO_SIDED|90.0|-11.08|24.62||Unadjusted two-sided p-value|MMRM|||||24.62|-11.08|0.6163
73875185|NCT04170543|147292197|OTHER||LS Mean Difference in Percent Change|2.43||||0.8537|TWO_SIDED|90.0|-17.35|26.95||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||26.95|-17.35|0.8537
73875186|NCT04170543|147292197|OTHER||LS Mean Difference in Percent Change|-15.63||||0.1989|TWO_SIDED|90.0|-32.14|4.89||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||4.89|-32.14|0.1989
73875187|NCT04170543|147292197|OTHER||LS Mean Difference in Percent Change|-17.96||||0.1346|TWO_SIDED|90.0|-34.01|1.99||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||1.99|-34.01|0.1346
73875188|NCT04170543|147292197|OTHER||LS Mean Difference in Percent Change|-6.38||||0.5683|TWO_SIDED|90.0|-22.59|13.23||Unadjusted two-sided p-value|MMRM|||||13.23|-22.59|0.5683
73875189|NCT04170543|147292198|OTHER||LS Mean Difference in Percent Change|-7.93||||0.4226|TWO_SIDED|90.0|-22.3|9.1||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||9.10|-22.30|0.4226
73875190|NCT04170543|147292198|OTHER||LS Mean Difference in Percent Change|-20.61||||0.0287|TWO_SIDED|90.0|-33.25|-5.58||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||-5.58|-33.25|0.0287
73875191|NCT04170543|147292198|OTHER||LS Mean Difference in Percent Change|-18.73||||0.0498|TWO_SIDED|90.0|-31.7|-3.3||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||-3.30|-31.70|0.0498
73875192|NCT04170543|147292198|OTHER||LS Mean Difference in Percent Change|-13.27||||0.1236|TWO_SIDED|90.0|-25.51|0.98||Unadjusted two-sided p-value|MMRM|||||0.98|-25.51|0.1236
73986244|NCT02642159|147517408|SUPERIORITY||LS Mean Difference|-33.3|||<|0.0001|TWO_SIDED|97.5|-46.6|-19.9||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Alirocumab group was compared to usual care group for the intent to prescribe fenofibrate using an appropriate contrast statement.||-19.9|-46.6|<0.0001
74034624|NCT03439748|147621653|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.030
73875193|NCT00452790|147292222|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.483
73875194|NCT00452790|147292222|SUPERIORITY_OR_OTHER|||||||0.698||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.698
74034625|NCT03439748|147621654|SUPERIORITY|||||||0.029||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.029
73875195|NCT00452790|147292222|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.782
73875196|NCT00452790|147292222|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
73875197|NCT00452790|147292222|SUPERIORITY_OR_OTHER|||||||0.729||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.729
73875198|NCT00452790|147292222|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of Induration-Severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
73875199|NCT00452790|147292222|SUPERIORITY_OR_OTHER|||||||0.819||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.819
73875200|NCT00452790|147292222|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.904
73875201|NCT00452790|147292222|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
73875202|NCT00452790|147292222|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
73875203|NCT00452790|147292222|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration and erythema) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.690
74034626|NCT03439748|147621656|SUPERIORITY|||||||0.494||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.494
73986245|NCT02642159|147517409|SUPERIORITY||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|97.5|-49.7|-36.3||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for overall ITT analysis. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-36.3|-49.7|<0.0001
73986246|NCT02642159|147517410|SUPERIORITY||LS Mean Difference|-55.7|||<|0.0001|TWO_SIDED|97.5|-71.8|-39.6||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|A separate hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for ITT-intent to prescribe fenofibrate stratum. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-39.6|-71.8|<0.0001
73986247|NCT02642159|147517411|SUPERIORITY||LS Mean Difference|-26.1|||<|0.0001|TWO_SIDED|97.5|-31.5|-20.7||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.7|-31.5|<0.0001
73986248|NCT02642159|147517412|SUPERIORITY||LS Mean Difference|-27.4|||<|0.0001|TWO_SIDED|97.5|-40.0|-14.8||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).||-14.8|-40.0|<0.0001
73986249|NCT02642159|147517413|SUPERIORITY||LS Mean Difference|-34.7|||<|0.0001|TWO_SIDED|97.5|-40.8|-28.6||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-28.6|-40.8|<0.0001
73986250|NCT02642159|147517414|SUPERIORITY||LS Mean Difference|-49.7|||<|0.0001|TWO_SIDED|97.5|-63.7|-35.8||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).||-35.8|-63.7|<0.0001
73986251|NCT02642159|147517415|SUPERIORITY||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|97.5|-37.3|-27.2||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-27.2|-37.3|<0.0001
73986252|NCT02642159|147517416|SUPERIORITY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|97.5|-47.4|-22.9||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-22.9|-47.4|<0.0001
73986253|NCT02642159|147517417|SUPERIORITY||LS Mean Difference|-24.6|||<|0.0001|TWO_SIDED|97.5|-28.8|-20.3||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.3|-28.8|<0.0001
73986254|NCT02642159|147517418|SUPERIORITY||LS Mean Difference|-25.3|||<|0.0001|TWO_SIDED|97.5|-35.4|-15.1||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-15.1|-35.4|<0.0001
73986255|NCT02642159|147517419|SUPERIORITY||Adjusted Mean Difference|-27.4|||<|0.0001|TWO_SIDED|97.5|-34.6|-20.1||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.1|-34.6|<0.0001
73986256|NCT02642159|147517420|SUPERIORITY||Adjusted Mean Difference|-22.8||||0.004|TWO_SIDED|97.5|-40.6|-5.0||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-5.0|-40.6|0.0040
73986257|NCT02642159|147517421|SUPERIORITY||Adjusted Mean Difference|-4.2||||0.2191|TWO_SIDED|97.5|-11.8|3.4||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||3.4|-11.8|0.2191
73986258|NCT02642159|147517422|SUPERIORITY||Adjusted Mean Difference|9.0||||0.2651|TWO_SIDED|97.5|-9.1|27.1||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|27.1|-9.1|0.2651
73986259|NCT04754594|147517454|OTHER||Geometric mean ratio|0.67|||||TWO_SIDED|95.0|0.5|0.9||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||0.90|0.50|
73986260|NCT04754594|147517455|OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|95.0|0.91|1.77||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||1.77|0.91|
73986261|NCT04754594|147517455|OTHER||Geometric mean ratio|0.95|||||TWO_SIDED|95.0|0.69|1.3||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||1.30|0.69|
73986262|NCT04754594|147517456|OTHER|Vaccine efficacy was estimated by 100\*(1 - illness rate ratio \[IRR\]), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|3.8|||||TWO_SIDED|95.0|-1227.8|93.0||||||||93.0|-1227.8|
73986263|NCT04754594|147517457|OTHER|Vaccine efficacy was estimated by 100\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|35.1|||||TWO_SIDED|95.0|-466.5|94.6||||||||94.6|-466.5|
73986264|NCT04754594|147517458|OTHER|Vaccine efficacy was estimated by 100\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|40.9|||||TWO_SIDED|95.0|-104.9|86.5||||||||86.5|-104.9|
73875204|NCT00452790|147292223|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.933
73986265|NCT00581009|147517491|EQUIVALENCE|repeated measure ANOVA|t-value|3.34|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73986266|NCT01332318|147517692|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.08|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 2 minus Arm 1.|||0.42|0.08|
73986267|NCT01332318|147517692|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.09|0.41|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 3 minus Arm 1.|||0.41|0.09|
73986268|NCT01332318|147517692|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.09|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 4 minus Arm 1.|||0.42|0.09|
73986269|NCT02820298|147517720|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|131.41|||||TWO_SIDED|90.0|117.03|147.56|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||147.56|117.03|
73986270|NCT02820298|147517722|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|110.29|||||TWO_SIDED|90.0|103.91|117.06|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||117.06|103.91|
74034627|NCT03439748|147621657|SUPERIORITY|||||||0.231||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.231
73986271|NCT02820298|147517723|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|108.34|||||TWO_SIDED|90.0|102.48|114.54|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||114.54|102.48|
73986272|NCT01780584|147517725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.05|TWO_SIDED|95.0|1.0|3.0||Repeated Anova was used to determine whether there was difference of FT3 levels between groups|ANOVA|||Null hypothesis: no difference of free T3 (FT3) levels will be found between placebo, low dose and high dose group. We anticipated a difference of 2 pg/ml in FT3 with a standard deviation of 0.8 pg/ml between groups. For a statistical power of 80% to identify a treatment effect and at a level significance of 0.05 (2-sided).||3|1|<0.05
73986273|NCT01780584|147517727|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.0||||0.31||95.0|3.0|10.0||Kruskal Wallis test was used to determine any difference of time of extubation between groups.|Kruskal-Wallis|||Null hypothesis: no difference of time to extubation between group. Statistical power 80% and level of significance 0.05||10|3|0.31
73986274|NCT01780584|147517728|SUPERIORITY_OR_OTHER||Median Difference (Net)|50.0||||0.4||95.0|40.0|60.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of length of stay in Intensive Care Unit. Statistical power 80% and level of significance 0.05.||60|40|0.4
73986275|NCT01780584|147517729|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.06||95.0|5.0|15.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of postoperative hospital length of stay between groups. Statistical power 80% and level of significance 0.05.||15|5|0.06
73875205|NCT00452790|147292223|SUPERIORITY_OR_OTHER|||||||0.776||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.776
73986276|NCT00663923|147517752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.1|<|0.05|TWO_SIDED|95.0|-0.62|-0.001||two - tailed p value \<0.05 were considered statistically significant.|t-test, 2 sided|in this study degrees of freedom is sample size - 1||||-.001|-.62|<0.05
73986277|NCT04380688|147517768|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.553|||||TWO_SIDED|90.0|0.145|1.952||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.952|0.145|
73986278|NCT04380688|147517776|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|1.314|||||TWO_SIDED|90.0|0.794|2.183||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||2.183|0.794|
73986279|NCT01967719|147517812|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|56.57|||||TWO_SIDED|95.0|44.21|72.39|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||72.39|44.21|
73986280|NCT01967719|147517813|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|55.64|||||TWO_SIDED|95.0|43.3|71.5|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||71.50|43.30|
73986281|NCT00796614|147517814|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.5388|TWO_SIDED|95.0|0.5|3.8|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||3.80|0.50|0.5388
73986282|NCT00796614|147517814|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.343|TWO_SIDED|95.0|0.2|1.76|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||1.76|0.20|0.3430
73986283|NCT00796614|147517814|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.5209|TWO_SIDED|95.0|0.5|3.97|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||3.97|0.50|0.5209
73986284|NCT00796614|147517814|SUPERIORITY_OR_OTHER|||||||0.9436|||||||Cochran-Armitage trend test|||A test of trend across the four treatment groups was performed as a secondary analysis in the proportion of responders across the dose levels using Cochran-Armitage trend test.||||0.9436
73986285|NCT00796614|147517815|SUPERIORITY_OR_OTHER|||||||0.3097|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.3097
73986286|NCT00796614|147517815|SUPERIORITY_OR_OTHER|||||||0.2676|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.2676
73986287|NCT00796614|147517815|SUPERIORITY_OR_OTHER|||||||0.6265|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.6265
73986288|NCT00796614|147517816|SUPERIORITY_OR_OTHER|||||||0.4359|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.4359
73986289|NCT00796614|147517816|SUPERIORITY_OR_OTHER|||||||0.0658|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.0658
73986290|NCT00796614|147517816|SUPERIORITY_OR_OTHER|||||||0.6709|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.6709
73986291|NCT00796614|147517817|SUPERIORITY_OR_OTHER|||||||0.5672|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5672
73986292|NCT00796614|147517817|SUPERIORITY_OR_OTHER|||||||0.8724|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8724
73986293|NCT00796614|147517817|SUPERIORITY_OR_OTHER|||||||0.7674|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7674
73986294|NCT00796614|147517817|SUPERIORITY_OR_OTHER|||||||0.5545|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5545
73986295|NCT00796614|147517817|SUPERIORITY_OR_OTHER|||||||0.4774|||||||Regression, Logistic|||Patient responded to tamsulosin-Medium dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.4774
74034628|NCT03439748|147621658|SUPERIORITY|||||||0.344||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.344
73986296|NCT00796614|147517817|SUPERIORITY_OR_OTHER|||||||0.8626|||||||Regression, Logistic|||Patient responded to tamsulosin-High dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use,and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8626
73986297|NCT00796614|147517818|SUPERIORITY_OR_OTHER|||||||0.9669|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.9669
73986298|NCT00796614|147517818|SUPERIORITY_OR_OTHER|||||||0.9231|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.9231
73986299|NCT00796614|147517818|SUPERIORITY_OR_OTHER|||||||0.636|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.6360
74039555|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2504|TWO_SIDED|95.0|0.89|1.59|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.89|0.2504
73875206|NCT00452790|147292223|SUPERIORITY_OR_OTHER|||||||0.596||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.596
73986300|NCT00796614|147517818|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||1.0000
73875207|NCT00452790|147292223|SUPERIORITY_OR_OTHER|||||||0.909||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.909
73875208|NCT00452790|147292223|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.683
73875209|NCT00452790|147292223|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
73875210|NCT00452790|147292223|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.203
73875211|NCT00452790|147292223|SUPERIORITY_OR_OTHER|||||||0.399||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.399
73986301|NCT00796614|147517818|SUPERIORITY_OR_OTHER|||||||0.4925|||||||Fisher Exact|||Patient responded to tamsulosin-medium dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||0.4925
74034629|NCT03439748|147621659|SUPERIORITY|||||||0.267||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.267
74039556|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0057|TWO_SIDED|95.0|1.12|1.98|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.98|1.12|0.0057
73875212|NCT00452790|147292223|SUPERIORITY_OR_OTHER|||||||0.382||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.382
73875213|NCT00452790|147292223|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
73875214|NCT00452790|147292223|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Fisher Exact|||Difference in incidence rates of any Local reaction (tenderness, induration, erythema) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.738
73875215|NCT00452790|147292224|SUPERIORITY_OR_OTHER|||||||0.918||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.918
73875216|NCT00452790|147292224|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.906
73875217|NCT00452790|147292224|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.404
73875218|NCT00452790|147292224|SUPERIORITY_OR_OTHER|||||||0.305||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.305
73956483|NCT00813488|147448995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5118||||0.0012||95.0|1.2|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|1.2|0.0012
73956484|NCT00813488|147448996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5826||||0.0074|TWO_SIDED|95.0|1.1|2.2|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.2|1.1|0.0074
73986302|NCT00796614|147517818|SUPERIORITY_OR_OTHER|||||||0.4977|||||||Fisher Exact|||Patient responded to tamsulosin-high dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||0.4977
73986303|NCT00796614|147517819|SUPERIORITY_OR_OTHER|||||||0.1373|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.1373
73986304|NCT00796614|147517819|SUPERIORITY_OR_OTHER|||||||0.744|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7440
73986305|NCT00796614|147517819|SUPERIORITY_OR_OTHER|||||||0.7703|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7703
73986306|NCT00796614|147517820|SUPERIORITY_OR_OTHER|||||||0.0808|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.0808
73986307|NCT00796614|147517820|SUPERIORITY_OR_OTHER|||||||0.8244|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8244
73986308|NCT00796614|147517820|SUPERIORITY_OR_OTHER|||||||0.5045|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5045
73986309|NCT01231464|147517823|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.498|||<|0.0001|TWO_SIDED|95.0|-1.897|-1.009|||ANCOVA||Besides treatment, the ANCOVA analysis also adjusted for baseline, center, gender, age, and classification of AR (Intermittent Allergic Rhinitis \[IAR\] or Persistent Allergic Rhinitis \[PER\]).|||-1.009|-1.897|<0.0001
73986310|NCT00993798|147517826|SUPERIORITY||LS Mean Difference|-1.27|STANDARD_DEVIATION|0.5||0.012|TWO_SIDED|95.0|-2.25|-0.28|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||-0.28|-2.25|0.012
73986311|NCT00993798|147517827|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.01|TWO_SIDED|95.0|-12.0|0.0|||Wilcoxon (Mann-Whitney)|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.0|-12.0|0.010
73986312|NCT00993798|147517828|SUPERIORITY|||||||0.014|||||||Log Rank|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||||0.014
73875219|NCT00452790|147292224|SUPERIORITY_OR_OTHER|||||||0.771||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.771
73875220|NCT00452790|147292224|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
73986313|NCT00993798|147517829|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.08||0.773|TWO_SIDED|95.0|-0.18|0.14|||ANOVA|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.14|-0.18|0.773
73986314|NCT01960348|147517831|SUPERIORITY||Least Squares Mean Difference|-33.99|STANDARD_ERROR_OF_MEAN|2.974|<|1e-07|TWO_SIDED|95.0|-39.86|-28.13||P=9.262E-24|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mNIS+7. The model includes baseline mNIS+7 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-28.13|-39.86|<0.0000001
73986315|NCT01960348|147517832|SUPERIORITY||Least Squares Mean Difference|-21.1|STANDARD_ERROR_OF_MEAN|3.1|<|1e-07|TWO_SIDED|95.0|-27.2|-15.0||P=1.103E-10|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in Norfolk QOL-DN total score. The model includes baseline Norfolk QOL-DN score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-15.0|-27.2|<0.0000001
73986316|NCT01960348|147517833|SUPERIORITY||Least Squares Mean Difference|-17.87|STANDARD_ERROR_OF_MEAN|2.254|<|1e-07|TWO_SIDED|95.0|-22.32|-13.43||P=1.404E-13|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in NIS-W. The model includes baseline NIS-W score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-13.43|-22.32|<0.0000001
73986317|NCT01960348|147517834|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|1.01|<|1e-07|TWO_SIDED|95.0|7.0|10.9||P=4.066E-16|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in R-ODS value. The model includes baseline R-ODS score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||10.9|7.0|<0.0000001
73986318|NCT01960348|147517835|SUPERIORITY||Least Squares Mean Difference|0.311|STANDARD_ERROR_OF_MEAN|0.0415|<|1e-07|TWO_SIDED|95.0|0.23|0.393||P=1.875E-12|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in 10-meter walk test result. The model includes baseline 10-meter walk test result as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||0.393|0.230|<0.0000001
73986319|NCT01960348|147517836|SUPERIORITY||Least Squares Mean Difference|115.7|STANDARD_ERROR_OF_MEAN|16.91|<|1e-07|TWO_SIDED|95.0|82.4|149.0||P=8.832E-11|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mBMI. The model includes baseline mBMI as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||149.0|82.4|<0.0000001
74034630|NCT03439748|147621660|SUPERIORITY|||||||0.051||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.051
73875221|NCT00452790|147292224|SUPERIORITY_OR_OTHER|||||||0.867||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.867
74034631|NCT04149899|147621663|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-4.9|STANDARD_DEVIATION|1.85|<|0.001|TWO_SIDED|95.0|-5.73|-4.14||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.14|-5.73|<0.001
74034632|NCT04149899|147621663|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-5.1|STANDARD_DEVIATION|2.51|<|0.001|TWO_SIDED|95.0|-6.14|-4.02||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.02|-6.14|<0.001
74034633|NCT04149899|147621663|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-6.0|STANDARD_DEVIATION|3.05|<|0.001|TWO_SIDED|95.0|-7.93|-4.07||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.07|-7.93|<0.001
74034634|NCT04149899|147621663|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Net)|0.14||||0.828|TWO_SIDED|95.0|-1.16|1.43||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model used the Baseline IOP values at Hour 2 as the covariate.|The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP change from Baseline, Hour 2 to Day 14, Hour 2 (the timepoint for the peak effect of Timolol 0.5%) was compared between WB007 0.15% and Timolol 0.5%.||1.43|-1.16|0.828
74034635|NCT04149899|147621663|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Net)|-0.42||||0.52|TWO_SIDED|95.0|-1.73|0.89||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model used the Baseline IOP values at Hour 2 as the covariate.|The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP change from Baseline, Hour 2 to Day 14, Hour 2 (the timepoint for the peak effect of Timolol 0.5%) was compared between WB007 0.4% and Timolol 0.5%.||0.89|-1.73|0.520
74034636|NCT04149899|147621664|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|0.14||||0.828|TWO_SIDED|95.0|-1.16|1.43||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA||The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP for WB007 0.15% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||1.43|-1.16|0.828
74034637|NCT04149899|147621664|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-0.42||||0.52|TWO_SIDED|95.0|-1.73|0.89||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA||The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.89|-1.73|0.520
74034638|NCT04149899|147621664|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-0.84||||0.283|TWO_SIDED|95.0|-2.39|0.71||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANOVA|The ANOVA model has the treatment group as the main effect.|The estimated treatment difference is based on the least-square means from the ANOVA model.|The mean IOP for WB007 0.15% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.71|-2.39|0.283
74034639|NCT04149899|147621664|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-1.02||||0.189|TWO_SIDED|95.0|-2.56|0.52||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANOVA|The ANOVA model has the treatment group as the main effect.|The estimated treatment difference is based on the least-square means from the ANOVA model.|The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.52|-2.56|0.189
73875222|NCT00452790|147292224|SUPERIORITY_OR_OTHER|||||||0.735||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.735
74034640|NCT00782418|147621665|SUPERIORITY_OR_OTHER||Least Squares Mean|1.6|||<|0.001||90.0|1.29|1.92||1-sided, alpha=0.05|ANOVA|||||1.92|1.29|<0.001
74034641|NCT00782418|147621665|SUPERIORITY_OR_OTHER||Least Squares Mean|0.95|||<|0.001||90.0|0.66|1.24|||ANOVA|1-sided, alpha=0.05||||1.24|0.66|<0.001
73956485|NCT00813488|147448997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.059||||0.8444|TWO_SIDED|95.0|0.6|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|0.6|0.8444
74034642|NCT00782418|147621665|SUPERIORITY_OR_OTHER||Least Squares Mean|2.32|||<|0.001||90.0|1.57|3.06|||ANOVA|1-sided, alpha=0.05||||3.06|1.57|<0.001
73956486|NCT00813488|147448998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6033|||<|0.0001|TWO_SIDED|95.0|1.4|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.8|1.4|<0.0001
74034643|NCT00782418|147621665|SUPERIORITY_OR_OTHER||Least Squares Mean|1.38|||<|0.001||90.0|0.64|2.12|||ANOVA|1-sided, alpha = 0.05||||2.12|0.64|<0.001
74034644|NCT00782418|147621666|SUPERIORITY_OR_OTHER||Least Squares Mean|23.1|||<|0.001||90.0|19.2|27.0|||ANOVA|1-side, alpha = 0.05||||27.0|19.2|<0.001
74034645|NCT00782418|147621666|SUPERIORITY_OR_OTHER||Least Squares Mean|16.4|||<|0.001||90.0|12.6|20.1|||ANOVA|1-side, alpha = 0.05||||20.1|12.6|<0.001
74034646|NCT00782418|147621667|SUPERIORITY_OR_OTHER||Least Squares Mean|545.0|||<|0.001||90.0|451.4|638.7|||ANOVA|1-side, alpha = 0.05||||638.7|451.4|<0.001
74034647|NCT00782418|147621667|SUPERIORITY_OR_OTHER||Least Squares Mean|246.6|||<|0.001||90.0|160.9|323.3|||ANOVA|1-side, alpha = 0.05||||323.3|160.9|<0.001
74034648|NCT02902172|147621725|NON_INFERIORITY||Mean Difference (Net)|0.85|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
74034649|NCT01773135|147621740|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||U statistic|||||||<0.001
74034650|NCT01100307|147621771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.85||||0.0003|TWO_SIDED|95.0|1.92|12.28||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|Cochran-Mantel-Haenszel|Stratification factors (HbA1c and baseline visual acuity categories)||The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||12.28|1.92|0.0003
74034651|NCT01100307|147621772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.0006|TWO_SIDED|95.0|1.1|3.94||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 6: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||3.94|1.10|0.0006
74034652|NCT01100307|147621772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.0001|TWO_SIDED|95.0|1.81|5.58||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 12: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||5.58|1.81|0.0001
74034653|NCT01100307|147621772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65||||0.0096|TWO_SIDED|95.0|0.65|4.65||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 18: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||4.65|0.65|0.0096
74034654|NCT01100307|147621772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|||<|0.0001|TWO_SIDED|95.0|2.19|6.32||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 24: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||6.32|2.19|<0.0001
74034655|NCT04026412|147621800|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.646|TWO_SIDED|96.0|0.77|1.19|||Cox proportional hazards model|||||1.19|0.77|0.6460
74034656|NCT04026412|147621801|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.87|1.41||||||||1.41|0.87|
74034657|NCT04026412|147621801|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.75|1.22||||||||1.22|0.75|
74034658|NCT04026412|147621801|SUPERIORITY||Hazard Ratio, log|1.16|||||TWO_SIDED|95.0|0.91|1.48||||||||1.48|0.91|
74034659|NCT04026412|147621802|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.05||||||||1.05|0.69|
74034660|NCT04026412|147621802|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.93|1.42||||||||1.42|0.93|
74034661|NCT04026412|147621803|SUPERIORITY||Difference in ORR|3.2|||||TWO_SIDED|95.0|-4.1|10.6||||||||10.6|-4.1|
74034662|NCT04026412|147621803|SUPERIORITY||Difference in ORR|7.8|||||TWO_SIDED|95.0|0.7|14.8||||||||14.8|0.7|
74034663|NCT04026412|147621803|SUPERIORITY||Difference in ORR|-4.7|||||TWO_SIDED|95.0|-11.8|2.5||||||||2.5|-11.8|
74034664|NCT04026412|147621806|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.82|1.23||||||||1.23|0.82|
74034665|NCT04026412|147621806|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.7|1.05||||||||1.05|0.70|
74034666|NCT04026412|147621806|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.95|1.44||||||||1.44|0.95|
74034667|NCT04026412|147621807|SUPERIORITY||Difference in ORR|3.5|||||TWO_SIDED|95.0|-4.1|11.1||||||||11.1|-4.1|
74034668|NCT04026412|147621807|SUPERIORITY||Difference in ORR|5.4|||||TWO_SIDED|95.0|-2.0|12.9||||||||12.9|-2.0|
74034669|NCT04026412|147621807|SUPERIORITY||Difference in ORR|-1.9|||||TWO_SIDED|95.0|-9.5|5.6||||||||5.6|-9.5|
74034670|NCT04026412|147621810|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.76|1.23||||||||1.23|0.76|
74034671|NCT04026412|147621810|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.65|1.06||||||||1.06|0.65|
74034672|NCT04026412|147621810|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.91|1.49||||||||1.49|0.91|
74034673|NCT04360187|147621818|SUPERIORITY||LS mean of difference|-17.13||||0.0002|TWO_SIDED|95.0|-25.98|-8.27|||Mixed effect Model for Repeated Measures||Crisaborole = Test Vehicle = Reference|||-8.27|-25.98|0.0002
73986320|NCT01960348|147517837|SUPERIORITY||Least Squares Mean Difference|-7.53|STANDARD_ERROR_OF_MEAN|2.213||0.0008|TWO_SIDED|95.0|-11.89|-3.16|||Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in COMPASS-31 total score. The model includes baseline COMPASS-31 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-3.16|-11.89|0.0008
73986321|NCT02151643|147517841|OTHER|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (\< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject's last observed phosphate concentration value (Last Observation Carried Forward \[LOCF\] imputation).||||||0.784|||||||F-test|||"ITT population - statistical analysis of linear model fit using an F-test at the 0.05 level.~It was determined that 150 subjects randomised at a ratio of 8:8:8:13:13 (low dose to high dose, placebo) would have \>90% power to detect either a statistically significant slope for the dose-response relationship, or, if the relationship was not linear, a statistically significant difference between the highest-dose group and the placebo group, using a two-sided 0.05 significance level."||||0.784
73986322|NCT02151643|147517841|OTHER|Sensitivity analysis of ITT primary analysis using baseline observation carried forward (BOCF) for any missing Day 29 (Visit 11) serum phosphate values.||||||0.905|||||||F-test|||"ITT population sensitivity analysis using baseline observation carried forward (BOCF) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.905
73986323|NCT02151643|147517841|OTHER|Sensitivity analysis of ITT primary analysis using multiple imputation (MI) for any missing Day 29 (Visit 11) serum phosphate values.||||||0.976|||||||F-test|||"ITT population sensitivity analysis using multiple imputation (MI) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.976
73986324|NCT02151643|147517841|OTHER|Sensitivity analysis of the primary ITT analysis using the Per Protocol (PP) population.||||||0.914|||||||F-test|||"Per protocol (PP) population sensitivity analysis to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.914
73986325|NCT02151643|147517841|OTHER|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (\< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject's last observed phosphate concentration value (Last Observation Carried Forward \[LOCF\] imputation).|Slope|-0.329|||<|0.001|TWO_SIDED||||||linear model - log (dose) - response|||ITT population - statistical analysis of the linear model log(PT20 dose)-response relationship to examine whether the linear trend of the change in phosphate level as a function of the log-transformed dose was statistically significant.||||<0.001
73986326|NCT02151643|147517841|OTHER||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group||||<0.001
73986327|NCT02151643|147517841|OTHER|||||||0.436|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - visit||||0.436
73986328|NCT02151643|147517841|OTHER|||||||0.959|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group versus Visit interaction||||0.959
73986329|NCT02151643|147517841|OTHER||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration||||<0.001
73986330|NCT02151643|147517841|OTHER|||||||0.144|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration versus Visit interaction||||0.144
73986331|NCT02151643|147517841|OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.2847|||ONE_SIDED|97.5||0.761||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||0.761||
73986332|NCT02151643|147517841|OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.2881|||ONE_SIDED|97.5||0.659||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||0.659||
73986333|NCT02151643|147517841|OTHER||Mean Difference (Final Values)|-0.705|STANDARD_ERROR_OF_MEAN|0.2891|||ONE_SIDED|97.5||-0.05||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||-0.05||
73986334|NCT02151643|147517841|OTHER||Mean Difference (Final Values)|-1.195|STANDARD_ERROR_OF_MEAN|0.255|||ONE_SIDED|97.5||-0.618||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||-0.618||
73986335|NCT02151643|147517842|OTHER|||||||0.497|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by PT20 dose group.||||0.497
73986336|NCT02151643|147517842|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by baseline hemoglobin.||||<0.001
73986337|NCT02151643|147517843|OTHER|||||||0.243|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by PT20 dose group.||||0.243
73986338|NCT02151643|147517843|OTHER|||||||0.867|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by Visit.||||0.867
73986339|NCT02151643|147517843|OTHER|||||||0.186|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by baseline serum ferritin concentration||||0.186
73986340|NCT02151643|147517844|OTHER|||||||0.068|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by PT20 dose group.||||0.068
73986341|NCT02151643|147517844|OTHER|||||||0.013|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Visit.||||0.013
73986342|NCT02151643|147517844|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Transferrin Saturation.||||<0.001
73986343|NCT02151643|147517845|OTHER|||||||0.004|||||||ANCOVA|||Repeated measures ANCOVA for change in Calcium x Phosphate Product from Baseline by PT20 dose group.||||0.004
73986344|NCT02151643|147517845|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Calcium x Phosphate Product.||||<0.001
73986345|NCT02151643|147517846|OTHER|||||||0.292|||||||paired z-test|||||||0.292
73986346|NCT02151643|147517846|OTHER|||||||0.047|||||||paired z-test|||||||0.047
73986347|NCT02151643|147517846|OTHER|||||||0.872|||||||paired z-test|||||||0.872
73986348|NCT02151643|147517846|OTHER|||||||0.288|||||||paired z-test|||||||0.288
73986349|NCT03619889|147517847|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73986350|NCT03619889|147517847|OTHER||Mean Difference (Net)|-1.2|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73986351|NCT03619889|147517854|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73986352|NCT03619889|147517854|OTHER||Mean Difference (Net)|-0.65|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73986353|NCT00197106|147517872|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is considered to be shown if the upper limit of the one-sided 95% confidence interval of the difference uflixotide-useretide does not exceed +15% (uflixotide-useretide represent the mean percentages of asthma symptom-free days of the two respective treatment groups).|Adjusted difference|2.6||||0.63||95.0|-8.1|13.4|||Repeated Measurements Anal. of Variance|Anal. = Analysis||||13.4|-8.1|0.63
73986354|NCT01084239|147517902|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|Result for index hospitalization||||||<0.001
73986355|NCT02679079|147517906|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|2.1||0.89|TWO_SIDED|95.0|-4.4|3.8||Nominal p-value is considered statistically significant if less than 0.05. To control for multiplicity, comparisons were tested sequentially.|Mixed Models Analysis|||||3.8|-4.4|0.89
73986356|NCT02679079|147517906|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|2.1||0.47|TWO_SIDED|95.0|-2.6|5.6||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||5.6|-2.6|0.47
73986357|NCT02679079|147517907|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.21|TWO_SIDED|95.0|-1.0|0.2||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||0.2|-1.0|0.21
74034674|NCT04360187|147621822|SUPERIORITY||Risk Difference (RD)|12.9||||0.0124|TWO_SIDED|95.0|2.8|23.1|||normal approximation to response rates||Crisaborole = Test Vehicle = Reference|||23.1|2.8|0.0124
74034675|NCT04360187|147621823|SUPERIORITY||Risk Difference (RD)|11.7||||0.0078|TWO_SIDED|95.0|3.1|20.3|||normal approximation to response rates||Crisaborole = Test Vehicle = Reference|||20.3|3.1|0.0078
73986358|NCT02679079|147517907|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.67|TWO_SIDED|95.0|-0.5|0.8||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||0.8|-0.5|0.67
73986359|NCT02679079|147517908|SUPERIORITY||Risk Difference (RD)|13.9||||0.24|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years)|Risk difference expressed as percentage.|||||0.24
73986360|NCT02679079|147517908|SUPERIORITY||Risk Difference (RD)|-4.5||||0.71|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.71
73986361|NCT02679079|147517909|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|2.9||0.52|TWO_SIDED|95.0|-7.7|3.9||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||3.9|-7.7|0.52
73986362|NCT02679079|147517909|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|2.9||0.64|TWO_SIDED|95.0|-4.5|7.2||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||7.2|-4.5|0.64
73986363|NCT02679079|147517910|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|4.5||0.6|TWO_SIDED|95.0|-11.2|6.5||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||6.5|-11.2|0.60
73986364|NCT02679079|147517910|SUPERIORITY||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|4.5||0.54|TWO_SIDED|95.0|-6.1|11.7||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||11.7|-6.1|0.54
73986365|NCT02679079|147517911|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.64|TWO_SIDED|95.0|-2.6|1.6||Comparison was not included in multiplicity adjustment procedure.|ANCOVA|||||1.6|-2.6|0.64
73986366|NCT02679079|147517911|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.1||0.77|TWO_SIDED|95.0|-2.5|1.9||Comparison was not included in multiplicity adjustment procedure.|ANCOVA|||||1.9|-2.5|0.77
73986367|NCT02679079|147517912|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.2||0.45|TWO_SIDED|95.0|-1.4|3.2||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||3.2|-1.4|0.45
73986368|NCT02679079|147517912|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.2||0.72|TWO_SIDED|95.0|-2.7|1.9||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||1.9|-2.7|0.72
73986369|NCT02679079|147517913|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.41|TWO_SIDED|95.0|-0.3|0.7||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||0.7|-0.3|0.41
73986370|NCT02679079|147517913|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|0.2|1.1||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||1.1|0.2|0.01
74034676|NCT04360187|147621824|SUPERIORITY||LS Mean of Difference|-0.79||||0.0009|TWO_SIDED|95.0|-1.26|-0.33|||Mixed effect Model for Repeated Measures||Crisaborole = Test Vehicle = Reference|||-0.33|-1.26|0.0009
74034677|NCT00256867|147621844|SUPERIORITY_OR_OTHER||Ratio Expressed as percent difference|-37.186|||<|0.0001|TWO_SIDED|95.0|-41.219|-32.879|||ANCOVA||Estimation parameter was Ratio to RSG Group expressed as percent difference from RSG group. Based on ANCOVA : Log(value) - log(baseline)= log(baseline) + sex + country + Treatment + Prior Sulfonylurea use|||-32.879|-41.219|<0.0001
74034678|NCT00256867|147621845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.09|-0.55|||ANCOVA||Change = Baseline + sex + country + Treatment + Prior Sulfonylurea use|||-0.55|-1.09|<0.0001
74034679|NCT00256867|147621849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.32|||<|0.0001||95.0|16.52|79.85|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior Sulfonylurea use) of having an LDL-c \< 100 mg/dL at Week 6 on All FDC RSG/SIMV groups compared to All RSG monotherapy groups|||79.85|16.52|<.0001
74034680|NCT00256867|147621850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.05|||<|0.0001|TWO_SIDED|95.0|2.32|7.07|||ANCOVA||Odds (logistic regression: log odds=Baseline + sex + Treatment + Prior SU use) of having an HbA1c \< 7% or reduction of HbA1c \>= 0.7% at Week 16 on All FDC group compared to Simv group.|||7.07|2.32|<0.0001
74034681|NCT00256867|147621851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED|95.0|2.21|7.0|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior SU use) of having an FPG \< 7.0 mmol/L or reduction of FPG \>= 1.67 mmol/L at Week 16 on All FDC group compared to Simv group.|||7|2.21|<0.0001
73986371|NCT02679079|147517914|SUPERIORITY||Risk Difference (RD)|14.8||||0.18|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.18
73986372|NCT02679079|147517914|SUPERIORITY||Risk Difference (RD)|-0.7||||0.95|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.95
73986373|NCT01490359|147517925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.008|TWO_SIDED|95.0|1.03|1.71||The GEE model included baseline measure of consistent condom use, intervention condition, time (6- vs. 12-mo follow-up), and type of partner (steady vs casual partners) with robust standard errors and an independent working correlation matrix.|generalized estimating equations (GEE)||Estimate is odds ratio (intervention vs. health control).|Assuming alpha = 0.05, a 2-tailed test, ICC = 0.01, 15% attrition at 12-month follow-up, and N = 1,152 men in the trial from 44 neighborhoods with an average of 26 men in each neighborhood, the trial was estimated to have 81% power to detect a 10% increase in consistent condom use from 32% to 42% in the HIV/STI intervention group.||1.71|1.03|.008
74034682|NCT02993224|147621857|SUPERIORITY||Difference of proportion|0.83|||<|0.0001|TWO_SIDED|95.0|0.75|0.89|||McNemar|||Preference for deferasirox DT vs deferasirox FCT||0.89|0.75|<.0001
74034683|NCT02993224|147621858|SUPERIORITY||Difference of proportion|0.78|||<|0.0001|TWO_SIDED|95.0|0.65|0.88|||McNemar|||Preference of deferasirox FCT vs deferasirox DT||0.88|0.65|<0.0001
74034684|NCT02993224|147621858|SUPERIORITY||Difference of proportion|0.83|||<|0.0001|TWO_SIDED|95.0|0.71|0.91|||McNemar|||Preference for deferasirox FCT vs previous iron chelation therapy||0.91|0.71|<0.0001
73986374|NCT04150341|147517933|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.881|TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|||||0.12|-0.14|0.881
73986375|NCT04150341|147517933|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.575|TWO_SIDED|95.0|-0.17|0.1|||Mixed Models Analysis|||||0.1|-0.17|0.575
73986376|NCT00405912|147517941|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.51
73986377|NCT00405912|147517941|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.25
73986378|NCT00405912|147517942|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Fisher Exact|1 sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.52
74034685|NCT02993224|147621859|SUPERIORITY||Difference of proportion|0.66|||<|0.0001|TWO_SIDED|95.0|0.51|0.77|||McNemar|||Deferasirox DT vs previous iron chelation therapy at Week 4||0.77|0.51|< 0.0001
74034686|NCT02993224|147621859|SUPERIORITY||Difference of proportion|0.59|||<|0.0001|TWO_SIDED|95.0|0.44|0.72|||McNemar|||Deferasirox DT vs previous iron chelation therapy at Week 24||0.72|0.44|< 0.0001
74034687|NCT02993224|147621861|SUPERIORITY||Least squares mean|-3.6|STANDARD_ERROR_OF_MEAN|2.3||0.1191|TWO_SIDED|95.0|-8.1|0.9|||ANCOVA|||Compliance of deferasirox DT vs deferasirox FCT||0.9|-8.1|0.1191
74034688|NCT02322320|147621877|SUPERIORITY|||||||0.6||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.60
74034689|NCT02322320|147621877|SUPERIORITY|||||||0.35||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.35
74034690|NCT02322320|147621877|SUPERIORITY|||||||0.68||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.68
73986379|NCT00405912|147517942|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.73
74034691|NCT02322320|147621878|SUPERIORITY|||||||0.57||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.57
74034692|NCT02322320|147621878|SUPERIORITY|||||||0.38||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.38
74034693|NCT02322320|147621878|SUPERIORITY|||||||0.77||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.77
74034694|NCT02322320|147621879|SUPERIORITY|||||||0.67||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.67
74034695|NCT02322320|147621879|SUPERIORITY|||||||0.2||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.20
74034696|NCT02322320|147621879|SUPERIORITY|||||||0.4||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.40
74034697|NCT02322320|147621880|SUPERIORITY|||||||0.43||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.43
74039557|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0126|TWO_SIDED|95.0|1.14|2.93|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.93|1.14|0.0126
73986380|NCT03730662|147517943|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-0.99|||<|0.001|TWO_SIDED|97.5|-1.13|-0.86|||Mixed Models Analysis|||||-0.86|-1.13|<0.001
73986381|NCT03730662|147517943|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-1.14|||<|0.001|TWO_SIDED|97.5|-1.28|-1.0|||Mixed Models Analysis|||||-1.00|-1.28|<0.001
73986382|NCT03730662|147517944|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|97.5|-0.93|-0.66|||Mixed Models Analysis|||||-0.66|-0.93|<0.001
73986383|NCT03730662|147517945|SUPERIORITY||Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|95.0|-9.8|-8.3|||Mixed Models Analysis|||||-8.3|-9.8|<0.001
73986384|NCT03730662|147517945|SUPERIORITY||Mean Difference (Net)|-11.4|||<|0.001|TWO_SIDED|95.0|-12.1|-10.6|||Mixed Models Analysis|||||-10.6|-12.1|<0.001
73986385|NCT03730662|147517945|SUPERIORITY||Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-14.3|-12.8|||Mixed Models Analysis|||||-12.8|-14.3|<0.001
73986386|NCT03730662|147517946|SUPERIORITY||Odds Ratio (OR)|4.78|||<|0.001|TWO_SIDED|95.0|3.47|6.58|||Regression, Logistic|||||6.58|3.47|<0.001
73986387|NCT03730662|147517946|SUPERIORITY||Odds Ratio (OR)|9.23|||<|0.001|TWO_SIDED|95.0|6.31|13.49|||Regression, Logistic|||||13.49|6.31|<0.001
73986388|NCT03730662|147517946|SUPERIORITY||Odds Ratio (OR)|11.87|||<|0.001|TWO_SIDED|95.0|7.88|17.89|||Regression, Logistic|||||17.89|7.88|<0.001
73875223|NCT00452790|147292224|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
73875224|NCT00452790|147292224|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
73875225|NCT00452790|147292224|SUPERIORITY_OR_OTHER|||||||0.842||95.0|||||Fisher Exact|||Difference in incidence rates of any Local Reaction (tenderness, induration, erythema) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.842
73875226|NCT00452790|147292225|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.908
73875227|NCT00452790|147292225|SUPERIORITY_OR_OTHER|||||||0.772||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the toddler dose, dose 4(12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.772
73875228|NCT00452790|147292225|SUPERIORITY_OR_OTHER|||||||0.681||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.681
73875229|NCT00452790|147292225|SUPERIORITY_OR_OTHER|||||||0.881||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.881
73875230|NCT00452790|147292225|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.509
73875231|NCT00452790|147292225|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the toddler dose (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
73875232|NCT00452790|147292225|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.880
73875233|NCT00452790|147292225|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.739
73875234|NCT00452790|147292225|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
74034698|NCT02322320|147621880|SUPERIORITY|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.70
73875235|NCT00452790|147292225|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
73875236|NCT00452790|147292225|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration, erythema) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.446
73875237|NCT00452790|147292226|SUPERIORITY_OR_OTHER|||||||0.625||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>=38 but \<=39 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.625
73875238|NCT00452790|147292226|SUPERIORITY_OR_OTHER|||||||0.375||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<=40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.375
73875239|NCT00452790|147292226|SUPERIORITY_OR_OTHER|||||||0.624||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.624
73875240|NCT00452790|147292226|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
73875241|NCT00452790|147292226|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.282
73875242|NCT00452790|147292226|SUPERIORITY_OR_OTHER|||||||0.307||95.0|||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.307
73875243|NCT00452790|147292226|SUPERIORITY_OR_OTHER|||||||0.939||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.939
73875244|NCT00452790|147292226|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.085
73875245|NCT00452790|147292227|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.111
73986389|NCT03730662|147517947|SUPERIORITY||Mean Difference (Net)|1.0||||0.672|TWO_SIDED|95.0|-3.7|5.7|||Mixed Models Analysis|||||5.7|-3.7|0.672
73986390|NCT03730662|147517947|SUPERIORITY||Mean Difference (Net)|-3.6||||0.134|TWO_SIDED|95.0|-8.2|1.1|||Mixed Models Analysis|||||1.1|-8.2|0.134
74034699|NCT02322320|147621880|SUPERIORITY|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.70
74034700|NCT00125658|147621892|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Primary Comparison (i.e., FTP vs. POWER) Data are reported as change scores, between the end of treatment block 1(10 weeks) and baseline; thus, this analysis directly compares FTP vs. Power. A negative value represents improvement (i.e., reduced trunk displacement) while a positive value represents an increase in compensatory trunk movement.||||<.001
74034701|NCT00125658|147621892|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Order effect, testing OrderA (FTP before POWER) vs. OrderB (POWER before FTP). Change scores for trunk displacement at the end of both treatment blocks (20 weeks) relative to baseline (e.g., 20 weeks - baseline) were compared between OrderA and OrderB.||||.002
74034702|NCT00125658|147621893|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||Tests effect of FTP vs. Power. The change in shoulder flexion range of motion was compared between baseline and the end of treatment Block 1 (i.e., 10 weeks).||||0.13
74034703|NCT00125658|147621893|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||Test the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP). The change in shoulder flexion range of motion was compared between the end of treatment (20 weeks) and baseline.||||0.048
74034704|NCT00125658|147621894|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Compares FTP vs POWER by comparing the change in elbow extension range of motion between the end of treatment block 1 (10 weeks) and baseline.||||.004
74034705|NCT00125658|147621894|SUPERIORITY_OR_OTHER|||||||0.034|||||||t-test, 2 sided|||Tests for the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP) by comparing the change in elbow extension range of motion between the end of overall treatment (20 weeks) and baseline.||||0.034
74034706|NCT00125658|147621895|SUPERIORITY_OR_OTHER|||||||0.056|||||||t-test, 2 sided|||Tests for differences between FTP vs. POWER by comparing the change in movement speed between the end of treatment block 1 (10 weeks) and baseline.||||0.056
74034707|NCT00125658|147621895|SUPERIORITY_OR_OTHER|||||||0.168|||||||t-test, 2 sided|||Tests for effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP))by comparing the change in movement speed between the end of overall treatment (20 weeks) and baseline.||||.168
74034708|NCT00125658|147621896|SUPERIORITY_OR_OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Tests the effects of FTP vs. POWER on motor impairment (UE FMA) by comparing the change in FMA between the end of treatment block 1 (10 weeks) and baseline.||||0.564
74034709|NCT00125658|147621896|SUPERIORITY_OR_OTHER|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Tests for an effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in UE FMA between the end of treatment (20 weeks) and baseline.||||0.948
73875246|NCT00452790|147292227|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
73875247|NCT00452790|147292227|SUPERIORITY_OR_OTHER|||||||0.488||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.488
73875248|NCT00452790|147292227|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Fisher Exact|||Difference in incidence rates of Decreased appetite within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.736
73986391|NCT03730662|147517947|SUPERIORITY||Mean Difference (Net)|-8.0|||<|0.001|TWO_SIDED|95.0|-12.6|-3.4|||Mixed Models Analysis|||||-3.4|-12.6|<0.001
73875249|NCT00452790|147292227|SUPERIORITY_OR_OTHER|||||||0.856||95.0|||||Fisher Exact|||Difference in incidence rates of Irritability within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.856
73875250|NCT00452790|147292227|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.098
73875251|NCT00452790|147292227|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Fisher Exact|||Difference in incidence rates of Decreased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.034
73875252|NCT00452790|147292227|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of Any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
73875253|NCT00452790|147292228|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.085
73875254|NCT00452790|147292228|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
73875255|NCT00452790|147292228|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.489
73875256|NCT00452790|147292228|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.840
73875257|NCT00452790|147292228|SUPERIORITY_OR_OTHER|||||||0.605||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.605
73875258|NCT00452790|147292228|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
73875259|NCT00452790|147292228|SUPERIORITY_OR_OTHER|||||||0.265||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.265
73986392|NCT01309243|147517953|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypothesis: The FTC/RPV/TDF group was at least 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA \< 50 copies/mL (response rate, as defined by the snapshot analysis algorithm) at Week 48.~Alternative hypothesis: The FTC/RPV/TDF group was less than 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA \< 50 copies/mL at Week 48."|Difference in the response rates|4.1|||||TWO_SIDED|95.0|-1.1|9.2|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and \> 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.|"The analysis was to assess the noninferiority of FTC/RPV/TDF versus EFV/FTC/TDF using a 95% confidence interval (CI) approach, with a noninferiority margin of 12% (lower bound of CI \> -12%).~700 subjects allocated 1:1 to either treatment arm was predicted to give \> 95% power when the proportion of responders in both treatment groups for the primary endpoint is 80% at Week 48."||9.2|-1.1|
73875260|NCT00452790|147292228|SUPERIORITY_OR_OTHER|||||||0.422||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.422
73875261|NCT00452790|147292229|SUPERIORITY_OR_OTHER|||||||0.815||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.815
73986393|NCT01309243|147517954|SUPERIORITY_OR_OTHER||Difference in the response rates|5.5|||||TWO_SIDED|95.0|-0.6|11.5|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and \> 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.|||11.5|-0.6|
73986394|NCT01309243|147517955|SUPERIORITY_OR_OTHER||Difference in LSM|11.0||||0.34|TWO_SIDED|95.0|-11.0|32.0||The p-value, and difference in least square means (LSM) and its 95% CI are from analysis of variance (ANOVA) with treatment and baseline HIV-1 RNA levels (≤ 100,000, \> 100,000 copies/mL) as fixed effect.|ANOVA|||||32|-11|0.34
73986395|NCT01309243|147517956|SUPERIORITY_OR_OTHER||Difference in LSM|20.0||||0.17|TWO_SIDED|95.0|-9.0|49.0||The p-value, and difference in LSM and its 95% CI are from ANOVA with treatment and baseline HIV-1 RNA levels (≤ 100,000, \> 100,000 copies/mL) as fixed effect.|ANOVA|||||49|-9|0.17
73986396|NCT01309243|147517957|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
73986397|NCT01309243|147517958|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
73986398|NCT01309243|147517959|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
73986399|NCT01309243|147517960|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
73986400|NCT03930238|147517963|SUPERIORITY||Group effect from Bayesian linear mixed|1646.0|||||TWO_SIDED|||||We did perform a Bayesian analysis which provided a posterior probability of 99.76% that the daily mean steps in the intervention group exceeded the daily mean steps in the comparison group.|Bayesian linear mixed effects regression||Posterior standard deviation = 578. We have 95% credible intervals - the interval that contains 95% of the posterior probability distribution of the parameter of interest - which ranges from 511 to 2781.|||||
73986401|NCT03930238|147517964|OTHER||Percentage|53.3|||||TWO_SIDED|||||||||||||
73986402|NCT00632931|147517966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||||90.0|-0.28|6.28||||||||6.28|-0.28|
73986403|NCT00632931|147517967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45||||||90.0|-1.38|4.72||||||||4.72|-1.38|
73986404|NCT00632931|147517968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.07||||||90.0|-0.17|6.31||||||||6.31|-0.17|
73986405|NCT00632931|147517969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84||||||90.0|-0.4|6.08||||||||6.08|-0.40|
74034710|NCT00125658|147621897|SUPERIORITY_OR_OTHER|||||||0.078|||||||t-test, 2 sided|||Tests for differences in FTP vs. POWER by comparing the change in RPR between the end of treatment block 1 (10 weeks) and baseline.||||0.078
73875262|NCT00452790|147292229|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
73875263|NCT00452790|147292229|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
73986406|NCT00632931|147517970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.44||||||90.0|3.21|9.68||||||||9.68|3.21|
73986407|NCT00632931|147517971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||||90.0|1.05|7.6||||||||7.60|1.05|
73986408|NCT00632931|147517972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66||||||90.0|-0.7|6.02||||||||6.02|-0.70|
73986409|NCT00632931|147517973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.51||||||90.0|3.19|9.82||||||||9.82|3.19|
73986410|NCT03009019|147517974|SUPERIORITY||Odds Ratio (OR)|1.4||||0.075|TWO_SIDED|95.0|0.97|2.03|||Fisher Exact|||Last Observation Carried Forward (LOCF)||2.03|0.97|0.075
73986411|NCT03009019|147517974|SUPERIORITY||Odds Ratio (OR)|1.47||||0.055|TWO_SIDED|95.0|1.0|2.14|||Fisher Exact|||Observed cases (OC)||2.14|1.00|0.055
73986412|NCT03009019|147517975|SUPERIORITY||Odds Ratio (OR)|1.75||||0.003|TWO_SIDED|95.0|1.22|2.52|||Regression, Logistic|||||2.52|1.22|0.003
73986413|NCT03009019|147517975|SUPERIORITY||Odds Ratio (OR)|1.76||||0.003|TWO_SIDED|95.0|1.22|2.55|||Regression, Logistic|||||2.55|1.22|0.003
73986414|NCT03341312|147517999|SUPERIORITY||ratio of LS Means|0.75|||||TWO_SIDED|95.0|0.42|1.16||||||||1.16|0.42|
73986415|NCT03341312|147517999|SUPERIORITY||ratio of LS Means|0.74|||||TWO_SIDED|95.0|0.49|1.01||||||||1.01|0.49|
73986416|NCT01812707|147518000|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 75 mg Q2W versus placebo~3. Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."||||<0.0001
73986417|NCT01812707|147518000|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||||||<0.0001
73986418|NCT01812707|147518000|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||||||<0.0001
73986419|NCT00265096|147518050|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise conparisons at 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||Null Hypothesis: No difference in ACR 20 response comparing Groups I vs II and Groups I vs III. Sample size (n=396; 110 placebo, 286 combined golimumab) provided \>98% power to detect a significant difference (alpha=0.05) in ACR 20 response between treatment groups, assuming equal proportions of subjects receiving methotrexate (MTX) at baseline and the difference in ACR 20 response of 27% in subjects without MTX and 17-27% in subjects with MTX, between placebo and combined golimumab groups.||||<0.001
73986420|NCT00265096|147518050|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||||||<0.001
73986421|NCT00265096|147518050|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||||||<0.001
73986422|NCT00265096|147518051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
73986423|NCT00265096|147518051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
73986424|NCT00265096|147518051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
73986425|NCT00265096|147518052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline Methotrexate (MTX) usage)||||||<0.001
73986426|NCT00265096|147518052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline MTX usage)||||||<0.001
73986427|NCT00265096|147518052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline MTX usage)||||||<0.001
73875264|NCT00452790|147292229|SUPERIORITY_OR_OTHER|||||||0.401||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.401
73986428|NCT00265096|147518053|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject's baseline Methotrexate (MTX) usage)||||||<0.001
73986429|NCT00265096|147518053|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (with treatment and subject's baseline MTX usage)||||||<0.001
73986430|NCT00265096|147518053|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject's baseline MTX usage)||||||<0.001
73986431|NCT00265096|147518054|SUPERIORITY_OR_OTHER|||||||0.015||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant.|ANOVA|Analysis of Variance (ANOVA) on van der Waerden scores with 2 factors: treatment group and participant's baseline methotrexate (MTX) usage||Null Hypothesis: There is no difference in change from baseline among 3 treatment groups. Sample size (n=396, 110 placebo, 286 combined golimumab) provided \>93% power to detect a significant difference (alpha=0.05) in change from baseline between treatment groups, assuming 50% of subjects received MTX at baseline, and mean change from baseline for combined golimumab of 0, and a mean increase for placebo of 0.1 in subjects who received MTX at baseline and 0.6 in subjects who did not receive MTX||||0.015
73986432|NCT00265096|147518054|SUPERIORITY_OR_OTHER|||||||0.011||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage||||||0.011
73986433|NCT00265096|147518054|SUPERIORITY_OR_OTHER|||||||0.086||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage||||||0.086
73986434|NCT00265096|147518055|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline Methotrexate (MTX) usage)||||||<0.001
74034711|NCT00125658|147621897|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||Tests the effect of treatment order (Order A (FTP \> POWER) vs. Order B (POWER \> FTP)) by comparing the change in RPR between the end of overall treatment (20 weeks) and baseline.||||0.4
74034712|NCT00125658|147621898|SUPERIORITY_OR_OTHER|||||||0.085|||||||t-test, 2 sided|||Tests for the effect of treatment (FTP vs. POWER) by comparing the change in movement smoothness between the end of treatment block 1 (10 weeks) and baseline.||||0.085
74034713|NCT00125658|147621898|SUPERIORITY_OR_OTHER|||||||0.635|||||||t-test, 2 sided|||Tests for the effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in movement smoothness between the end of overall treatment (20 weeks) and baseline.||||0.635
73875265|NCT00452790|147292229|SUPERIORITY_OR_OTHER|||||||0.511||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.511
73875266|NCT00452790|147292229|SUPERIORITY_OR_OTHER|||||||0.487||95.0|||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.487
73986435|NCT00265096|147518055|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
74034714|NCT02876055|147621899|SUPERIORITY|||||||0.542|||||||Wilcoxon (Mann-Whitney)|||||||0.542
74034715|NCT02876055|147621899|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74034716|NCT02876055|147621899|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
74034717|NCT01515306|147621921|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geo LS means|1.09|||||TWO_SIDED|90.0|0.93|1.29|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1.||||1.29|0.93|
74034718|NCT01515306|147621923|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geo LS means|0.97|||||TWO_SIDED|90.0|0.83|1.13|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.||||1.13|0.83|
73986436|NCT00265096|147518055|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
73986437|NCT00666835|147518058|EQUIVALENCE|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval -0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (\<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Point estimate of difference (ANCOVA)|0.084|||||TWO_SIDED|95.0|-0.17|0.338||||||||0.338|-0.170|
73986438|NCT00666835|147518059|EQUIVALENCE|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval -0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (\<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Difference LSM of Epo Hexal & Erypo|0.189|||||TWO_SIDED|95.0|-0.039|0.418||||||||0.418|-0.039|
74034719|NCT04019093|147621940|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,46) = .001||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the beverage condition X group interaction.||||.99
74034720|NCT04019093|147621940|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(1,46)=12.55||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of beverage condition.||||<.0001
74034721|NCT04019093|147621940|SUPERIORITY|||||||0.015|||||||ANOVA|F(1,46)=6.32||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of group.||||.015
74039558|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|2.69|||<|0.0001|TWO_SIDED|95.0|1.71|4.22|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.22|1.71|<.0001
73875267|NCT00452790|147292229|SUPERIORITY_OR_OTHER|||||||0.388||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.388
73875268|NCT00452790|147292229|SUPERIORITY_OR_OTHER|||||||0.753||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.753
73875269|NCT01712204|147292268|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|STANDARD_ERROR_OF_MEAN|0.113||0.1356|TWO_SIDED|95.0|0.62|1.07|||Possion regression|||||1.07|0.62|0.1356
73875270|NCT02360228|147292269|OTHER|||||||0.47|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups.H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)||||0.47
73986439|NCT03897049|147518060|SUPERIORITY||Odds Ratio (OR)|0.961||||0.914|TWO_SIDED|95.0|0.463|1.994|||Regression, Logistic|||||1.994|0.463|0.914
73875271|NCT02360228|147292271|OTHER|||||||0.37|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the PANSS score from day 5 to baseline. H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)||||0.37
73875272|NCT02360228|147292272|OTHER|||||||0.11|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||"The null hypothesis was that there is no difference between the changes in the BACS score from baseline to 5 days between the groups:~H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)"||||0.11
73875273|NCT04186871|147292308|SUPERIORITY|RESPONSE DIFFERENCE (95% CI) VS PLACEBO|Response Difference|-27.8|||||TWO_SIDED|95.0|-77.5|21.9||||||||21.9|-77.5|
73986440|NCT03897049|147518061|SUPERIORITY||Odds Ratio (OR)|0.979||||0.99|TWO_SIDED|95.0|0.473|2.074|||Regression, Logistic|||||2.074|0.473|0.990
73986441|NCT03897049|147518062|SUPERIORITY||Odds Ratio (OR)|1.434||||0.167|TWO_SIDED|95.0|0.861|2.39|||Regression, Logistic|||||2.390|0.861|0.167
73986442|NCT03897049|147518063|SUPERIORITY||Odds Ratio (OR)|1.492||||0.118|TWO_SIDED|95.0|0.903|2.466|||Regression, Logistic|||||2.466|0.903|0.118
73986443|NCT03897049|147518064|SUPERIORITY||Odds Ratio (OR)|1.335||||0.265|TWO_SIDED|95.0|0.803|2.221|||Regression, Logistic|||||2.221|0.803|0.265
73986444|NCT03897049|147518065|SUPERIORITY||Odds Ratio (OR)|0.99||||0.971|TWO_SIDED|95.0|0.593|1.654|||Regression, Logistic|||||1.654|0.593|0.971
73875274|NCT04186871|147292308|SUPERIORITY|ODDS RATIO (95% CI) VS PLACEBO|Odds Ratio (OR)|0.32||||0.3117|TWO_SIDED|95.0|0.04|2.73|||Cochran-Mantel-Haenszel|||||2.73|0.04|0.3117
73875275|NCT04186871|147292309|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9||||||||4.9|-2.8|
73986445|NCT03897049|147518066|SUPERIORITY||Mean Difference (Net)|-0.27||||0.942|TWO_SIDED||||||Regression, Linear|||||||0.942
73986446|NCT03897049|147518067|SUPERIORITY||Mean Difference (Net)|0.02||||0.741|TWO_SIDED||||||Regression, Linear|||||||0.741
73986447|NCT03897049|147518068|SUPERIORITY||Mean Difference (Net)|0.07||||0.494|TWO_SIDED||||||Regression, Linear|||||||0.494
73986448|NCT03897049|147518069|SUPERIORITY||Mean Difference (Net)|0.15||||0.651|TWO_SIDED||||||Regression, Linear|||||||0.651
73986449|NCT03897049|147518070|SUPERIORITY||Mean Difference (Net)|0.3||||0.022|TWO_SIDED||||||Regression, Linear|||||||0.022
73986450|NCT03897049|147518071|SUPERIORITY||Mean Difference (Net)|2.85||||0.189|TWO_SIDED||||||Regression, Linear|||||||0.189
73986451|NCT03897049|147518072|SUPERIORITY||Mean Difference (Final Values)|3.07||||0.218|TWO_SIDED||||||Regression, Linear|||||||0.218
74039559|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3485|TWO_SIDED|95.0|0.79|1.99|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|0.79|0.3485
73875276|NCT04186871|147292309|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 24|Mean Difference (Final Values)|-8.3|||||TWO_SIDED|95.0|-11.5|-5.0||||||||-5.0|-11.5|
73875277|NCT04186871|147292309|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 24|Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-9.3|-5.2||||||||-5.2|-9.3|
73875278|NCT04186871|147292310|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|16.7|||||TWO_SIDED|95.0|-31.8|65.2||||||||65.2|-31.8|
73875279|NCT04186871|147292310|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.22|18.04||||||||18.04|0.22|
73875280|NCT04186871|147292311|SUPERIORITY|RESPONSE DIFFERENCE (95% CI) VS PLACEBO|Response Difference|-11.9|||||TWO_SIDED|95.0|-57.1|33.3||||||||33.3|-57.1|
73875281|NCT04186871|147292311|SUPERIORITY|ODDS RATIO (95% CI) VS PLACEBO|Odds Ratio (OR)|0.4||||0.593|TWO_SIDED|95.0|0.02|10.02|||Cochran-Mantel-Haenszel|||||10.02|0.02|0.5930
73986452|NCT03897049|147518073|SUPERIORITY||Odds Ratio (OR)|0.479||||0.149|TWO_SIDED|95.0|0.173|1.305|||Regression, Logistic|||||1.305|0.173|0.149
73986453|NCT03897049|147518074|SUPERIORITY||Odds Ratio (OR)|1.111||||0.839|TWO_SIDED|95.0|0.403|3.063|||Regression, Logistic|||||3.063|0.403|0.839
73986454|NCT03897049|147518075|SUPERIORITY||Odds Ratio (OR)|3.302||||0.063|TWO_SIDED|95.0|0.937|11.641|||Regression, Logistic|||||11.641|0.937|0.063
73986455|NCT03897049|147518076|SUPERIORITY||Mean Difference (Net)|-0.08||||0.65|TWO_SIDED||||||Regression, Linear|||||||0.650
73986456|NCT03897049|147518077|SUPERIORITY||Mean Difference (Net)|0.09||||0.531|TWO_SIDED||||||Regression, Linear|||||||0.531
73986457|NCT03897049|147518078|SUPERIORITY||Mean Difference (Net)|-0.03||||0.761|TWO_SIDED||||||Regression, Linear|||||||0.761
73986458|NCT03897049|147518079|SUPERIORITY||Mean Difference (Net)|0.11||||0.503|TWO_SIDED||||||Regression, Linear|||||||0.503
73986459|NCT03897049|147518080|SUPERIORITY||Mean Difference (Net)|0.01||||0.541|TWO_SIDED||||||Regression, Linear|||||||0.541
73986460|NCT03897049|147518081|SUPERIORITY||Mean Difference (Net)|-0.02||||0.537|TWO_SIDED||||||Regression, Linear|||||||0.537
73986461|NCT03897049|147518082|SUPERIORITY||Mean Difference (Net)|0.19||||0.057|TWO_SIDED||||||Regression, Linear|||||||0.057
73986462|NCT03897049|147518083|SUPERIORITY||Mean Difference (Net)|0.1||||0.402|TWO_SIDED||||||Regression, Linear|||||||0.402
73986463|NCT03897049|147518084|SUPERIORITY||Mean Difference (Net)|0.15||||0.308|TWO_SIDED||||||Regression, Linear|||||||0.308
73986464|NCT03897049|147518085|SUPERIORITY||Mean Difference (Net)|0.48||||0.001|TWO_SIDED||||||Regression, Linear|||||||0.001
73986465|NCT03319719|147518086|SUPERIORITY||Mean Difference (Net)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.42|-2.33||p-value from paired two-sided t-tests of no difference between test and control groups.|t-test, 2 sided|||||-2.33|-3.42|<0.0001
73986466|NCT02460562|147518109|SUPERIORITY||||||<|0.05||||||Mean salivary fluoride concentrations (part per million) between groups were assessed at different time points using repeated measures analysis of variance. Saliva fluoride concentration from each groups were compared with baseline using a t-test.|ANOVA|||Mean saliva fluoride concentration (part per million) collected at different time points was compared in order to assess the change in capacity for fluoride release and recharge from the resin denture base and to assess differences between the control and the intervention group.||||<0.05
73986467|NCT02460562|147518110|SUPERIORITY||Odds Ratio (OR)|0.45|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||Caries assessments were performed to examine the difference in mean number of surface caries (DMFS) ± standard deviation between the control and the intervention groups at baseline and at 1.5 years.The transition (∆Q) of developed new caries surfaces (ICDAS score 1-3) from baseline to 1.5 years of follow-up for the two groups was analyzed with respect to arrest or progress rates. Numbers of new caries surfaces were compared by independent t-test, Pearson chi-square and correlation coefficient.||||<0.05
73986468|NCT00187135|147518138|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.||||0.5
73986469|NCT00187135|147518138|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. The sample size needed to ensure adequate statistical power for this comparison was obtained.||||0.5
73986470|NCT00187135|147518139|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.||||0.5
73986471|NCT00187135|147518140|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in heart rate (HR) on pain (Y/N) while controlling for treatment.||||0.87
73986472|NCT00187135|147518141|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in respiratory rate (RR) on pain (Y/N) while controlling for treatment.||||0.67
73986473|NCT00187135|147518142|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in blood presure (BP) on pain (Y/N) while controlling for treatment.||||0.52
73986474|NCT00187135|147518143|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of motion (Y/N)on pain (Y/N) while controlling for treatment.||||0.99
74034722|NCT04019093|147621941|SUPERIORITY|||||||0.76|||||||ANOVA|F(2,82)=.20||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X group interaction.||||.76
74034723|NCT04019093|147621941|SUPERIORITY|||||||0.52|||||||ANCOVA|F(2,82)=.66||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X beverage condition interaction.||||.52
74034724|NCT04019093|147621941|SUPERIORITY|||||||0.04|||||||ANOVA|F(1,41)=4.53, p=.04||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of beverage condition.||||.04
73986475|NCT01951261|147518156|NON_INFERIORITY|sample size calculation was made, considering it appropriate to set a limit of non-inferiority with respect to the main variable of 1.2 months (36 days), the study being lower if it will have exacerbation before this period of time, with a follow-up of 6 months, It was required to include a sample of 58 patients per group for a potency of 80% and a significance level of 5%.|||||<|0.05||||||The reported p-value was calculated.Statistical analysis of the main variable was performed using the Kaplan-Meier method and log-rank test|Log Rank|||||||<0.05
73986476|NCT04098497|147518177|OTHER|||||||0.09|||||||t-test, 2 sided|t = 1.74, df = 28||baseline to day 42 comparison||||0.09
73986477|NCT04098497|147518178|OTHER|||||||0.09|||||||t-test, 2 sided|t = 1.75, df = 28||baseline to day 42||||0.09
73986478|NCT04098497|147518179|SUPERIORITY|||||||0.13|||||||Regression, Linear|β = 0.14, z = 1.51||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.13
73986479|NCT04098497|147518180|SUPERIORITY|||||||0.007|||||||Regression, Linear|β = 0.38, z = 2.71||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.007
73986480|NCT04098497|147518181|SUPERIORITY|||||||0.57|||||||Regression, Linear|β = 0.03, z = 0.58||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.57
73986481|NCT04098497|147518182|SUPERIORITY|||||||0.25|||||||Regression, Linear|β = 0.06, z = 1.15||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.25
73986482|NCT00297778|147518183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.0103||95.0|-3.4|-0.5|||ANCOVA|||||-0.5|-3.4|0.0103
73986483|NCT00297778|147518184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.758||||0.0535||95.0|0.992|3.115|||Regression, Logistic|||||3.115|0.992|0.0535
73986484|NCT00297778|147518185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.0346||95.0|-1.5|-0.1|||ANCOVA|||||-0.1|-1.5|0.0346
73986485|NCT00297778|147518186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.5244||95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|-1|0.5244
73986486|NCT00297778|147518187|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.141||95.0|0.0|0.0|||van Elteren (country stratification)|||||0|0|0.141
73986487|NCT00297778|147518188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.003||95.0|-1.9|-0.4|||ANCOVA|||||-0.4|-1.9|0.003
73986488|NCT00297778|147518189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0034||95.0|-3.7|-0.7|||ANCOVA|||||-0.7|-3.7|0.0034
73986489|NCT00297778|147518190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4||||0.0007||95.0|-5.4|-1.5|||ANCOVA|||||-1.5|-5.4|0.0007
73986490|NCT00297778|147518191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.821||||0.006||95.0|1.187|2.794|||Regression, Logistic|||||2.794|1.187|0.006
73986491|NCT00297778|147518192|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.3||||0.1925||95.0|-3.3|0.8|||van Elteren (country stratification)|||||0.8|-3.3|0.1925
73986492|NCT00297778|147518193|SUPERIORITY_OR_OTHER||Hodges-Lehmann est of diff in medians|0.04||||0.0337||95.0|0.0|0.09|||Wilcoxon rank sum (Van Elteren's test)|||||0.09|0|0.0337
73875282|NCT04186871|147292312|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-14.6|||||TWO_SIDED|95.0|-36.9|7.7||||||||7.7|-36.9|
74034725|NCT04019093|147621941|SUPERIORITY|||||||0.017|||||||ANOVA|F(1,41)=6.24||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of group.||||.017
73986493|NCT00297778|147518194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.8471||95.0|-5.6|4.6|||ANCOVA|||||4.6|-5.6|0.8471
73986494|NCT00297778|147518195|SUPERIORITY_OR_OTHER||Hodges-Lehmann est of diff in medians|0.0||||0.141|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank sum (Van Elteren's test)||95% Confidence interval is Distribution-free Confidence Interval (Moses).|N's exclude patients from the analysis set with incomplete data||0.0|0.0|0.1410
73986495|NCT00297778|147518196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5231|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||N's exclude patients from the analysis set with incomplete data||0.2|-0.5|0.5231
73986496|NCT03280108|147518199|NON_INFERIORITY|Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in Least Squares Means (LSM) between the 2 groups (TFNT00 - SN60AT). Non-inferiority margin = 0.10 logMAR.|Least Squares Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0103|||ONE_SIDED|95.0||0.041||||||||0.041||
73986497|NCT03280108|147518200|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73986498|NCT03280108|147518206|SUPERIORITY||Least Squares Mean Difference|-0.257|STANDARD_ERROR_OF_MEAN|0.0153|<|0.001|TWO_SIDED|95.0|-0.287|-0.227|||Mixed Models Analysis|||||-0.227|-0.287|<0.001
73986499|NCT03280108|147518207|SUPERIORITY||Mantel-Haenszel common difference|71.2|||||TWO_SIDED|95.0|61.87|80.46||||||||80.46|61.87|
73986500|NCT04089332|147518237|OTHER||Slope|-0.4465||||0.162|TWO_SIDED||||||Regression, Linear|||WASI II (Verbal IQ) vs HOMA-IR|Adjusted R-squared = 0.117|||0.162
73986501|NCT04089332|147518237|OTHER||Slope|0.6704||||0.082|TWO_SIDED||||||Regression, Linear|||WASI II (Performance IQ) vs HOMA-IR|Adjusted R-squared = 0.221|||0.082
73986502|NCT04089332|147518237|OTHER||Slope|-0.8486||||0.286|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Flanker Inhibitory Control and Attention) vs HOMA-IR|Adjusted R-squared = 0.0503|||0.286
73986503|NCT04089332|147518237|OTHER||Slope|-0.0266||||0.635|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Pattern Comparison) vs HOMA-IR|Adjusted R-squared = 0|||0.635
73986504|NCT04089332|147518237|OTHER||Slope|-0.1588||||0.061|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Picture Sequence) vs HOMA-IR|Adjusted R-squared = 0.381|||0.061
73986505|NCT04089332|147518237|OTHER||Slope|0.099||||0.479|TWO_SIDED||||||Regression, Linear|||WRAML (Picture Memory) vs. HOMA-IR|Adjusted R-squared = 0|||0.479
73986506|NCT04089332|147518237|OTHER||Slope|0.0676||||0.965|TWO_SIDED||||||Regression, Linear|||D-KEFS (Color-Word Interference) vs. HOMA-IR|Adjusted R-squared = 0|||0.965
73986507|NCT04089332|147518237|OTHER||Slope|-0.0091||||0.039|TWO_SIDED||||||Regression, Linear|||D-KEFS (Trail Making Test) vs. HOMA-IR|Adjusted R-squared = 0.324|||0.039
73986508|NCT04089332|147518237|OTHER||Slope|-4.2085||||0.018|TWO_SIDED||||||Regression, Linear|||PedsQL (Child 8-12 / Teen 13-18) vs. HOMA-IR|Adjusted R-squared = 0.0423|||0.018
73986509|NCT04089332|147518238|OTHER||Slope|-1.1138||||0.558|TWO_SIDED||||||Regression, Linear|||Change in Gray Matter Perfusion vs. HOMA-IR|Adjusted R-square = 0|||0.558
73986510|NCT04089332|147518238|OTHER||Slope|-5.8089||||0.057|TWO_SIDED||||||Regression, Linear|||Baseline Gray Matter vs. HOMA-IR|Adjusted R-squared = 0.18|||0.057
73986511|NCT04089332|147518239|OTHER||Slope|-0.4465||||0.377|TWO_SIDED||||||Regression, Linear|||WASI II (Verbal IQ) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.377
73986512|NCT04089332|147518239|OTHER||Slope|0.6704||||0.402|TWO_SIDED||||||Regression, Linear|||WASI II (Performance IQ) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.402
73986513|NCT04089332|147518239|OTHER||Slope|-0.8486||||0.203|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Flanker Inhibitory Control and Attention) vs. Cerebral Blood Flow|Adjusted R-squared = 0.207|||0.203
73986514|NCT04089332|147518239|OTHER||Slope|-0.0266||||0.967|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Pattern Comparison) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.967
73986515|NCT04089332|147518239|OTHER||Slope|-0.1588||||0.616|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Picture Sequence) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.616
73875283|NCT04186871|147292312|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.46||||0.1639|TWO_SIDED|95.0|0.15|1.39|||Chi-squared|||||1.39|0.15|0.1639
73986516|NCT04089332|147518239|OTHER||Slope|0.099||||0.287|TWO_SIDED||||||Regression, Linear|||WRAML (Picture Memory) vs. Cerebral Blood Flow|Adjusted R-squared = 0.0497|||0.287
73986517|NCT04089332|147518239|OTHER||Slope|0.0676||||0.225|TWO_SIDED||||||Regression, Linear|||D-KEFS (Color-Word Interference) vs. Cerebral Blood Flow|Adjusted R-squared = 0.106|||0.225
73986518|NCT04089332|147518239|OTHER||Slope|-0.0091||||0.872|TWO_SIDED||||||Regression, Linear|||D-KEFS (Trail Making Test) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.872
73986519|NCT04089332|147518239|OTHER||Slope|-4.2085||||0.66|TWO_SIDED||||||Regression, Linear|||PedsQL (Child 8-12 / Teen 13-18) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.66
74039560|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.46||||0.0642|TWO_SIDED|95.0|0.98|2.19|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.19|0.98|0.0642
73986520|NCT02256488|147518241|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22.||1.5|0.667|
73986521|NCT02256488|147518241|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for for all 3 influenza strains at day 22||1.5|0.667|
73986522|NCT02256488|147518241|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|1.12|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22||1.5|0.667|
73986523|NCT02963922|147518280|SUPERIORITY|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised participants regardless of premature discontinuation of trial product.|Treatment difference|-4.32|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-5.48|-3.16|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, body mass index (BMI) groups and sex as factors and baseline body weight as covariate.||-3.16|-5.48|< .0001
73986524|NCT02963922|147518280|SUPERIORITY|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised participants assuming that all participants remained on trial product (on-treatment principle).|Treatment difference|-5.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-6.3|-3.91|||MMRM||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit.||-3.91|-6.30|< .0001
73986525|NCT02963922|147518281|SUPERIORITY||Odds Ratio (OR)|3.41|||<|0.0001|TWO_SIDED|95.0|2.19|5.31|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups and sex as factors and baseline body weight as covariate.||5.31|2.19|<.0001
73986526|NCT02963922|147518281|SUPERIORITY||Odds Ratio (OR)|4.73|||<|0.0001|TWO_SIDED|95.0|3.04|7.36|||Mixed model for repeated measurements||Liraglutide 3.0 mg/Placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||7.36|3.04|<.0001
73986527|NCT02825849|147518337|SUPERIORITY|||||||0.824|||||||Chi-squared|||||||.824
73986528|NCT01350388|147518338|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|||||||0.84
73986529|NCT01350388|147518339|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANCOVA|||||||0.73
73986530|NCT01350388|147518340|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|||||||0.23
73986531|NCT01350388|147518341|SUPERIORITY_OR_OTHER|||||||0.88|||||||ANCOVA|||||||0.88
73986532|NCT01350388|147518342|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
73986533|NCT01350388|147518343|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
73875284|NCT04186871|147292313|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE WEEK 12|Mean Difference (Final Values)|-1.61|||||TWO_SIDED|95.0|-2.11|-1.11||||||||-1.110|-2.110|
73986534|NCT03640754|147518345|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73986535|NCT03640754|147518345|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73986536|NCT03640754|147518346|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73986537|NCT03640754|147518346|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73986538|NCT03640754|147518347|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73986539|NCT03640754|147518347|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73986540|NCT03640754|147518348|SUPERIORITY|||||||0.199|||||||t-test, 1 sided|||||||0.199
73986541|NCT03640754|147518348|SUPERIORITY|||||||0.189|||||||t-test, 1 sided|||||||0.189
73986542|NCT03640754|147518349|SUPERIORITY|Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||||0.398|||||||Mixed Models Analysis|||||||0.398
73986543|NCT03640754|147518349|SUPERIORITY|Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||||0.391|||||||Mixed Models Analysis|||||||0.391
73986544|NCT03640754|147518350|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|||Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||0.232
73875285|NCT04186871|147292313|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.567|||||TWO_SIDED|95.0|-1.855|-1.28||||||||-1.280|-1.855|
73875286|NCT04186871|147292313|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.043|||||TWO_SIDED|95.0|-0.534|0.62||||||||0.620|-0.534|
73986545|NCT03640754|147518350|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||0.085
73986546|NCT03640754|147518351|SUPERIORITY|||||||0.501|||||||Mixed Models Analysis|||||||0.501
73875287|NCT04186871|147292314|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.741|||||TWO_SIDED|95.0|-2.256|-1.226||||||||-1.226|-2.256|
73875288|NCT04186871|147292314|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.698|||||TWO_SIDED|95.0|-1.998|-1.399||||||||-1.399|-1.998|
73875289|NCT04186871|147292314|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.043|||||TWO_SIDED|95.0|-0.553|0.639||||||||0.639|-0.553|
73875290|NCT04186871|147292315|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-19.495|||||TWO_SIDED|95.0|-24.861|-14.128||||||||-14.128|-24.861|
73875291|NCT04186871|147292315|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-18.767|||||TWO_SIDED|95.0|-21.848|-15.686||||||||-15.686|-21.848|
73875292|NCT04186871|147292315|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.728|||||TWO_SIDED|95.0|-5.463|6.919||||||||6.919|-5.463|
73875293|NCT04186871|147292316|EQUIVALENCE|ADJUSTED MEAN AT DIFFERENCE WEEK 12|Mean Difference (Final Values)|-19.2|||||TWO_SIDED|95.0|-24.3|-14.1||||||||-14.1|-24.3|
73875294|NCT04186871|147292316|EQUIVALENCE|ADJUSTED MEAN AT DIFFERENCE WEEK 12|Mean Difference (Final Values)|-18.5|||||TWO_SIDED|95.0|-21.4|-15.5||||||||-15.5|-21.4|
73986547|NCT03640754|147518351|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.370
73986548|NCT03640754|147518352|SUPERIORITY|||||||0.333|||||||Mixed Models Analysis|||||||0.333
73986549|NCT03640754|147518352|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||0.014
73986550|NCT03640754|147518353|SUPERIORITY|||||||0.124|||||||Mixed Models Analysis|||||||0.124
74034726|NCT04019093|147621941|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(2,82)=48.41||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of pressure level.||||<.0001
74034727|NCT04019093|147621942|SUPERIORITY|||||||0.5|||||||ANOVA|F (2, 82) = 0.69||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level X group interaction.||||.50
74039561|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|2.16|||<|0.0001|TWO_SIDED|95.0|1.48|3.14|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.14|1.48|<.0001
73875295|NCT04186871|147292316|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-5.2|6.6||||||||6.6|-5.2|
73875296|NCT04186871|147292317|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-4.1|||||TWO_SIDED|95.0|-28.1|19.9||||||||19.9|-28.1|
73986551|NCT03640754|147518353|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|||||||0.175
73986552|NCT03640754|147518354|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
73986553|NCT03640754|147518354|SUPERIORITY|||||||0.077|||||||Mixed Models Analysis|||||||0.077
73986554|NCT03640754|147518358|SUPERIORITY|||||||0.047|||||||t-test, 1 sided|||||||0.047
73986555|NCT03640754|147518358|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|||||||0.139
73986556|NCT03640754|147518358|SUPERIORITY|||||||0.395|||||||t-test, 1 sided|||||||0.395
73875297|NCT04186871|147292317|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.31|2.32||||||||2.32|0.31|
73875298|NCT04186871|147292318|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-6.5|||||TWO_SIDED|95.0|-22.8|9.9||||||||9.9|-22.8|
73875299|NCT04186871|147292318|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.11|2.34||||||||2.34|0.11|
73875300|NCT02781610|147292347|NON_INFERIORITY|The non-inferiority margin is -3.5%.|Mean Difference (Final Values)|-0.7||||0.0164|TWO_SIDED|95.0|-3.3|2.0|||ANOVA|Adjusted for four dichotomous randomization strata.||The ERR non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population for 93% power assuming 2-sided alpha=0.05 with 155 PP participants per arm. Difference between ERR treatment duration arms is ERR-10 - ERR-14.||2.0|-3.3|0.0164
73875301|NCT02781610|147292348|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.568|TWO_SIDED|95.0|-1.3|1.1|||ANOVA|Adjusted for four dichotomous randomization strata.||The NERR superiority test was a priori designed to be conducted on the Intent-to-Treat (ITT) population for 91% power to detect a 2.5% difference, assuming 2-sided alpha=0.05 with 285 ITT participants per arm. Difference between NERR treatment duration arms is NERR-21 - NERR-14.||1.1|-1.3|0.568
73875302|NCT02781610|147292349|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.546|TWO_SIDED|95.0|-2.4|4.6|||t-test, 2 sided|||Difference between ERR treatment duration arms is ERR-10 - ERR-14.||4.6|-2.4|0.546
73875303|NCT02781610|147292350|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.14|TWO_SIDED|95.0|-3.7|0.5|||t-test, 2 sided|||Difference between NERR treatment duration arms is NERR-21 - NERR-14.||0.5|-3.7|0.140
73875304|NCT02781610|147292351|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.563|TWO_SIDED|95.0|-0.42|0.77|||t-test, 2 sided|||Difference between ERR treatment duration arms is ERR-10 - ERR-14.||0.77|-0.42|0.563
73875305|NCT02781610|147292352|SUPERIORITY|Difference between NERR treatment duration arms is NERR-21 - NERR-14.|Mean Difference (Final Values)|0.29||||0.083|TWO_SIDED|95.0|-0.04|0.61|||t-test, 2 sided|||||0.61|-0.04|0.083
73875306|NCT02679287|147292353|SUPERIORITY||Mean Difference (Final Values)|1.8|||<|0.0001|TWO_SIDED|95.0|1.2|2.4|||Mixed Models Analysis|||The null hypothesis is that there is no difference in percentage of time \<70 mg/dL in SAP vs. evening-overnight CLC session. Change in HbA1c during study sessions was used as a covariate of the model.||2.4|1.2|<0.0001
73986557|NCT03640754|147518359|SUPERIORITY|||||||0.147|||||||t-test, 1 sided|||||||0.147
73986558|NCT03640754|147518359|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|||||||0.160
73986559|NCT03640754|147518359|SUPERIORITY|||||||0.152|||||||t-test, 1 sided|||||||0.152
73986560|NCT03640754|147518360|SUPERIORITY|||||||0.286|||||||t-test, 1 sided|||||||0.286
73986561|NCT03640754|147518360|SUPERIORITY|||||||0.107|||||||t-test, 1 sided|||||||0.107
73986562|NCT03640754|147518361|SUPERIORITY|||||||0.289|||||||t-test, 1 sided|||||||0.289
73986563|NCT03640754|147518361|SUPERIORITY|||||||0.338|||||||t-test, 1 sided|||||||0.338
73986564|NCT03640754|147518362|SUPERIORITY|||||||0.393|||||||t-test, 1 sided|||||||0.393
73986565|NCT03640754|147518362|SUPERIORITY|||||||0.365|||||||t-test, 1 sided|||||||0.365
73986566|NCT03640754|147518363|SUPERIORITY|||||||0.406|||||||t-test, 1 sided|||||||0.406
73986567|NCT03640754|147518363|SUPERIORITY|||||||0.494|||||||t-test, 1 sided|||||||0.494
74034728|NCT04019093|147621942|SUPERIORITY|||||||0.21|||||||ANOVA|F(2,82)=1.58||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level interaction.||||.21
73875307|NCT00549445|147292449|OTHER|Student t test||||||0.045||||||Threshold for significance is P-Value \< 0.05|t-test, 1 sided|||||||0.045
73956487|NCT00813488|147448999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3334|||<|0.0001|TWO_SIDED|95.0|1.2|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.5|1.2|<0.0001
73956488|NCT00635817|147449017|SUPERIORITY_OR_OTHER|||||||0.099||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.099
73956489|NCT00635817|147449017|SUPERIORITY_OR_OTHER|||||||0.074||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.074
73956490|NCT00635817|147449017|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.026
73956491|NCT00635817|147449017|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.102
73956492|NCT00635817|147449018|SUPERIORITY_OR_OTHER|||||||0.008||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.008
73956493|NCT00635817|147449018|SUPERIORITY_OR_OTHER|||||||0.002||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.002
73956494|NCT00635817|147449018|SUPERIORITY_OR_OTHER|||||||0.347||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.347
73956495|NCT00635817|147449018|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.150
73956496|NCT03820986|147449021|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by BRAF mutation positive (Yes vs. No).|Hazard Ratio (HR)|0.83||||0.0295||95.0|0.69|1.0|||Log Rank|One-sided p-value based on log-rank test and stratified by BRAF mutation positive (Yes vs. No).|HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.00|0.69|0.0295
73956497|NCT03820986|147449022|SUPERIORITY|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by BRAF mutation positive (Yes vs. No).|Hazard Ratio (HR)|1.2||||0.9521|TWO_SIDED|95.0|0.97|1.48|||Log Rank|One-sided p-value based on log-rank test and stratified by BRAF mutation positive (Yes vs. No).|HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.48|0.97|0.9521
73956498|NCT03820986|147449027|OTHER||Difference in LS means|-3.69||||0.0345|TWO_SIDED|95.0|-7.1|-0.27|||cLDA model||Difference in LS means=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|Based on a constrained longitudinal data analysis (cLDA) model with GHS/QoL as the response variable, with covariates for treatment by time interaction, stratification factor BRAF mutation status as covariate.||-0.27|-7.10|0.0345
73956499|NCT03820986|147449028|OTHER||Difference in LS means|-5.49||||0.0004|TWO_SIDED|95.0|-8.53|-2.45|||cLDA model||Difference in LS means=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|Based on a cLDA model with PF as the response variable, with covariates for treatment by time interaction, stratification factor BRAF mutation status as covariate.||-2.45|-8.53|0.0004
73956500|NCT03820986|147449029|OTHER||Hazard Ratio (HR)|1.58||||0.0001|TWO_SIDED|95.0|1.25|2.0|||Log Rank||HR=Lenvatinib + Pembrolizumab vs. Placebo + Pembrolizumab|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by BRAF mutation status (positive vs wild type or unknown)||2.00|1.25|0.0001
73956501|NCT03820986|147449030|OTHER||Hazard Ratio (HR)|1.95||||0.0001|TWO_SIDED|95.0|1.52|2.5|||Log Rank||HR=Lenvatinib + Pembrolizumab vs. Placebo + Pembrolizumab|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by BRAF mutation status (positive vs wild type or unknown).||2.50|1.52|.0001
73956502|NCT00708097|147449046|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.98||||0.5757|TWO_SIDED|95.0|-5.0|8.97||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.97|-5.00|0.5757
73956503|NCT00708097|147449047|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.17||||0.5387|TWO_SIDED|95.0|-4.79|9.14||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.14|-4.79|0.5387
73986568|NCT05329402|147518364|NON_INFERIORITY|"The non-inferiority hypothesis is tenable if the lower limit of 95% confidence interval of the difference in the primary effectiveness evaluation indicator device cutting and anastomosis success rate between the test group and the control group is greater than the non-inferiority critical value (-10%)."|Mean Difference (Final Values)|0.0||||0.9727|TWO_SIDED|95.0|-0.0285|0.0273|||Wald|||||0.0273|-0.0285|0.9727
73956504|NCT00708097|147449047|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.79||||0.4306|TWO_SIDED|95.0|-4.18|9.77||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.77|-4.18|0.4306
73986569|NCT01679613|147518368|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|160.48|STANDARD_DEVIATION|17.9||1|TWO_SIDED|90.0|148.245|173.736||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %).~The standard deviation is actually the geometric coefficient of variation (gCV)."|||173.736|148.245|1.0000
73986570|NCT01679613|147518369|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|179.62|STANDARD_DEVIATION|29.9||1|TWO_SIDED|90.0|157.557|204.779||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV (in %).~Ratio calculated as nintedanib+ketoconazole divided by nintedanib"|||204.779|157.557|1.0000
73986571|NCT01679613|147518370|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|168.09|STANDARD_DEVIATION|17.9||1|TWO_SIDED|90.0|155.252|181.981||p-value for ratio outside interval 0.8 to 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV.~Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %)."|||181.981|155.252|1.000
73986572|NCT03924947|147518441|NON_INFERIORITY|The pre-specified non-inferiority margin of upper bound of the two-sided 99% confidence interval for the treatment difference was 12%.|Least Squares (LS) Mean of Difference|0.94|STANDARD_ERROR_OF_MEAN|1.176|||TWO_SIDED|99.0|-2.37|4.259|||||LS mean (standard error \[SE\]) and LS mean confidence interval (CI) are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Double Blind Creon - Double Blind Creon MP||4.259|-2.370|
73986573|NCT03924947|147518442|OTHER|Descriptive|LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|-2.456|2.392|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||2.392|-2.456|
73986574|NCT03924947|147518442|OTHER|Descriptive|LS Mean of Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.035|||TWO_SIDED|95.0|-3.005|1.345|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon AAPIS||1.345|-3.005|
73986575|NCT03924947|147518443|OTHER|Descriptive|LS Mean of Difference|-3.36|STANDARD_ERROR_OF_MEAN|3.541|||TWO_SIDED|95.0|-10.699|3.987|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||3.987|-10.699|
73986576|NCT03924947|147518443|OTHER|Descriptive|LS Mean of Difference|3.27|STANDARD_ERROR_OF_MEAN|4.016|||TWO_SIDED|95.0|-5.172|11.702|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|DB Creon - DB Creon AAPIS||11.702|-5.172|
74034729|NCT04019093|147621942|SUPERIORITY|||||||0.053|||||||ANOVA|F(2,82)=3.06||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the pressure level X group interaction.||||.053
73986577|NCT03924947|147518444|OTHER|Descriptive|LS Mean of Difference|34.68|STANDARD_ERROR_OF_MEAN|62.253|||TWO_SIDED|95.0|-94.424|163.786|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||163.786|-94.424|
73986578|NCT03924947|147518444|OTHER|Descriptive|LS Mean of Difference|-16.56|STANDARD_ERROR_OF_MEAN|60.858|||TWO_SIDED|95.0|-144.418|111.298|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|DB Creon - DB Creon AAPIS||111.298|-144.418|
73986579|NCT03924947|147518445|NON_INFERIORITY|The pre-specified non-inferiority margin of upper bound of the two-sided 99% confidence interval for the treatment difference was 12%.|LS Mean of Difference|-1.15|STANDARD_ERROR_OF_MEAN|1.302|||TWO_SIDED|99.0|-4.892|2.602|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Double Blind Creon - Double Blind Creon AAPIS||2.602|-4.892|
73986580|NCT01907113|147518446|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.24|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|96.17|145.38|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||145.38|96.17|
73986581|NCT01907113|147518446|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|119.94|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|96.25|149.47|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||149.47|96.25|
73986582|NCT01907113|147518446|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|166.29|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|134.44|205.68|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||205.68|134.44|
73986583|NCT01907113|147518446|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|148.29|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|119.89|183.42|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||183.42|119.89|
73986584|NCT01907113|147518447|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.83|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|93.62|150.84|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||150.84|93.62|
74034730|NCT04019093|147621942|SUPERIORITY|||||||0.98|||||||ANOVA|F(1,41)=.001||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X group interaction.||||.98
73875308|NCT03932760|147292450|OTHER|Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.|Mean estimates by time|0.913|STANDARD_ERROR_OF_MEAN|1.085||0.612|TWO_SIDED|95.0|-1.228|3.055|||Mixed Models Analysis||Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.|We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of EPDS between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum controlling for screening EPDS score. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.|"Overall test of significance for Fixed Effects. Higher EPDS scores signify worsened symptoms of depression. Time uses start of study as reference controlling for screen EPDS.~Group VCI (AC reference): F=0.260, p=0.612~Time (Baseline as reference): F=9.021, p\<0.001~Group\*Time: F=0.537, p=0.748~Estimates for group, time, and group\*time interactions~Group:~Estimate=0.913 (SE=1.085) \[CI LB=-1.228, UB=3.055\]~Time:~Post: estimate=-2.766 (0.853) \[-4.445, -1.087\]~2 months: estimate=-1.517 (0.862) \[-3.214, 0.180\]~4 months: estimate=-3.186 (0.862) \[-4.883, -1.489\]~6 months: estimate=-2.781 (0.872) \[-4.498, -1.065\]~8 months: estimate=-3.103 (0.872) \[-4.819, -1.386\]~Group\*Time:~Post: estimate=-1.157 (1.214) \[-3.547, 1.232\]~2 months: estimate=-1.361 (1.210) \[-3.742, 1.019\]~4 months: estimate= 0.183 (1.209) \[-2.196, 2.562\]~6 months: estimate=-0.508 (1.223) \[-2.914, 1.898\]~8 months: estimate=-0.127 (1.220) \[-2.529, 2.275\]"|3.055|-1.228|0.612
73986585|NCT01907113|147518447|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|102.27|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|79.33|131.85|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||131.85|79.33|
73986586|NCT01907113|147518447|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|120.68|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|94.42|154.25|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||154.25|94.42|
73986587|NCT01907113|147518447|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|103.75|STANDARD_DEVIATION|29.7|||TWO_SIDED|95.0|81.18|132.61|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||132.61|81.18|
73986588|NCT00833898|147518462|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.020
73986589|NCT00833898|147518463|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Mixed Models Analysis|||||||0.15
73986590|NCT00833898|147518464|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Mixed Models Analysis|||||||0.029
74034731|NCT04019093|147621942|SUPERIORITY|||||||0.71|||||||ANOVA|F(2,82)=.34||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of pressure level.||||.71
74034732|NCT04019093|147621942|SUPERIORITY|||||||0.71|||||||ANOVA|F(1,41)=.14||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of group.||||.71
73986591|NCT00833898|147518465|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.003
73986592|NCT00833898|147518466|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Mixed Models Analysis|||||||0.012
73986593|NCT00833898|147518467|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
73986594|NCT00833898|147518468|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Mixed Models Analysis|||||||0.44
73986595|NCT00833898|147518469|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Mixed Models Analysis|||||||0.75
73986596|NCT00833898|147518470|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
73986597|NCT00833898|147518471|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
73986598|NCT00833898|147518472|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Mixed Models Analysis|||||||0.55
73986599|NCT00833898|147518473|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||0.30
73986600|NCT00833898|147518474|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
73986601|NCT00833898|147518475|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
73986602|NCT00833898|147518476|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
73986603|NCT00833898|147518477|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
73986604|NCT00833898|147518478|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.58
73986605|NCT00833898|147518478|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.33
73986606|NCT00833898|147518479|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
73986607|NCT00833898|147518480|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.18
73986608|NCT00833898|147518480|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||1.00
73986609|NCT00833898|147518481|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.43
73986610|NCT00833898|147518481|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.72
73986611|NCT00833898|147518482|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.43
73986612|NCT00833898|147518482|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.72
73986613|NCT01057888|147518494|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||<|0.05|TWO_SIDED|95.0|1.0|1.7|||Regression, Cox|It is a robust, clustered stratified Cox regression model|The control group serves as the denominator. The telephone reminder group serves as the numerator.|The null hypothesis is that there is no difference in total immunization status between the control group and the group receiving telephone (autodialer) reminders. This was analyzed using a clustered, stratified Cox model.||1.7|1.0|<0.05
73986614|NCT01057888|147518494|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6|||<|0.01|TWO_SIDED|95.0|1.3|2.1|||Regression, Cox|We used a robust, clustered, stratified Cox regression model.|The control group represents the denominator. The letter reminder group represents the numerator.|||2.1|1.3|<0.01
73986615|NCT01057888|147518494|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.075|TWO_SIDED|95.0|1.0|1.6|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator.|The null hypothesis was that there is no difference in the percentage of fully vaccinated adolescents between the mailed reminder versus the telephone reminder arms||1.6|1.0|0.075
73986616|NCT01057888|147518495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||<|0.01|TWO_SIDED|95.0|1.1|1.3|||Regression, Cox||The control group represents the denominator and the mailed reminder group represents the numerator.|The null hypothesis was that a difference in well child care rates among adolescents whose families received a mailed reminder compared to the control group||1.3|1.1|<0.01
73986617|NCT01057888|147518495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||<|0.05|TWO_SIDED|95.0|1.0|1.3|||Regression, Cox||The control group represents the denominator and the telephone reminder group represents the numerator|The null hypothesis is the the well child care rates of adolescents in the telephone reminder group would not differ from those of the control group||1.3|1.0|<0.05
73986618|NCT01057888|147518495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.234|TWO_SIDED|95.0|1.0|1.2|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator|The null hypothesis was that there would be no difference in the well child care rate among adolescents in the mailed reminder arm versus adolescents in the telephone reminder arm of the intervention||1.2|1.0|0.234
73986619|NCT05109117|147518558|SUPERIORITY||Adjusted Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|1.7|3.9|||ANCOVA|Analysis of Covariance (ANCOVA) model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 2 hours post-treatment||3.9|1.7|<0.0001
73986620|NCT05109117|147518558|SUPERIORITY||Adjusted Mean Difference|1.5||||0.0077|TWO_SIDED|95.0|0.4|2.7|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 4 hours post-treatment||2.7|0.4|0.0077
73986621|NCT05109117|147518558|SUPERIORITY||Adjusted Mean Difference|1.8||||0.0019|TWO_SIDED|95.0|0.7|2.9|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 6 hours post-treatment||2.9|0.7|0.0019
73986622|NCT05109117|147518558|SUPERIORITY||Adjusted Mean Difference|1.0||||0.0707|TWO_SIDED|95.0|-0.1|2.2|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 8 hours post-treatment||2.2|-0.1|0.0707
73986623|NCT03972137|147518566|OTHER|A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline (BL) to Quit Day.|Mean Difference (Final Values)|11.42|STANDARD_DEVIATION|6.08||0.003|TWO_SIDED|95.0|5.79|17.05||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean cigarettes smoked per day at Baseline and Quit Date (Mean CPD at Baseline - Mean CPD at Quit Date).|||17.05|5.79|.003
73986624|NCT03972137|147518566|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from baseline (BL) to 3-month follow-up session (3MFU).|Mean Difference (Final Values)|11.9|STANDARD_DEVIATION|8.45||0.067|TWO_SIDED|95.0|-1.55|25.35||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean cigarettes smoked per day at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.|||25.35|-1.55|.067
73986625|NCT03972137|147518567|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total score from baseline (BL) to 2-weeks post-quit (2W).|Mean Difference (Final Values)|19.67|STANDARD_DEVIATION|11.91||0.01|TWO_SIDED|95.0|7.17|32.17||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 2-weeks post-quit. Estimated value reported is reflective of the n=6 participants that attended the 2-weeks post quit session.|||32.17|7.17|.010
73986626|NCT03972137|147518567|OTHER|A paired-samples t-test was conducted to examine the difference in DASS-21 Total scores from baseline (BL) to 1-month post-quit (1M).|Mean Difference (Final Values)|31.2|STANDARD_DEVIATION|20.4||0.027|TWO_SIDED|95.0|5.88|56.52||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 1-month post-quit. Estimated value reported is reflective of the n=5 participants that attended the 1-month post-quit session.|||56.52|5.88|.027
73986627|NCT03972137|147518567|OTHER|A paired-samples t-test was conducted to evaluate the difference in DASS-21 total scores from baseline (BL) to 3-month follow up (3MFU).|Mean Difference (Final Values)|25.75|STANDARD_DEVIATION|15.5||0.045|TWO_SIDED|95.0|1.09|50.41||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.|||50.41|1.09|.045
73986628|NCT01797822|147518595|OTHER|Statistical comparison between groups was made with t-test. A sample size of 20 subjects was calculates to have 90% power of detecting a statistical difference (P\<0.05) in change in corneal staining pre and post low humidity challenge.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73986629|NCT00843115|147518656|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.||||<0.0001
73986630|NCT00843115|147518657|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.||||<0.0001
73986631|NCT00843115|147518658|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986632|NCT00843115|147518659|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986633|NCT00843115|147518660|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986634|NCT00843115|147518661|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
74034733|NCT04019093|147621942|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(1,41)=55.02||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of beverage condition.||||<.0001
73986635|NCT00843115|147518662|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986636|NCT00843115|147518663|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986637|NCT00843115|147518664|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986638|NCT00843115|147518665|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986639|NCT00843115|147518666|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986640|NCT00843115|147518667|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
74034734|NCT02435277|147621956|OTHER|||||||0.0475||||||Total daily dose is twice the respective dose, Pairwise Comparison using Control as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 84 Evaluable Population (n=43)||||0.0475
74034735|NCT02435277|147621956|OTHER|||||||0.0912|||||||ANCOVA|||||||0.0912
74034736|NCT02435277|147621956|OTHER|||||||0.0458|||||||ANCOVA|||||||0.0458
73956505|NCT00708097|147449047|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.07|||<|0.0001|TWO_SIDED|95.0|-32.09|-18.06||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-18.06|-32.09|<0.0001
73986641|NCT00843115|147518668|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986642|NCT00843115|147518669|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986643|NCT00843115|147518670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986644|NCT00843115|147518671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986645|NCT00843115|147518672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986646|NCT00843115|147518673|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986647|NCT00843115|147518674|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate @ 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986648|NCT00843115|147518675|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986649|NCT00843115|147518676|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
73986650|NCT00843115|147518677|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||Change from baseline in total score at Week 12||||<0.0001
73986651|NCT00843115|147518678|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||Change from baseline in total score at Week 12 Last Observation Carried Forward||||<0.0001
73986652|NCT00843115|147518679|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||correlation coefficient|P value tests whether Pearson Product Correlation Coefficient is significantly different from zero||||||<0.0001
73986653|NCT00843115|147518680|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||correlation coefficient|p-value tests whether Pearson Product Correlation Coefficient is significantly different from zero||||||<0.0001
73986654|NCT00843115|147518681|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
73986655|NCT00843115|147518682|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||||||<0.0001
73986656|NCT00843115|147518683|SUPERIORITY_OR_OTHER|||||||0.0713|||||||correlation coefficient|||||||0.0713
73986657|NCT00843115|147518684|SUPERIORITY_OR_OTHER|||||||0.0225|||||||Correlation coefficient|||||||0.0225
73986658|NCT00843115|147518685|SUPERIORITY_OR_OTHER|||||||0.0152|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||0.0152
73986659|NCT00843115|147518686|SUPERIORITY_OR_OTHER|||||||0.0229|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||||||0.0229
73986660|NCT00843115|147518687|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
73986661|NCT00843115|147518688|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
73986662|NCT00843115|147518689|SUPERIORITY_OR_OTHER|||||||0.7963|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12."||||||0.7963
73986663|NCT00843115|147518690|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."||||||1.0000
73986664|NCT00843115|147518691|SUPERIORITY_OR_OTHER|||||||0.0719|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||0.0719
73986665|NCT00843115|147518692|SUPERIORITY_OR_OTHER|||||||0.1779|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."||||||0.1779
73986666|NCT00843115|147518693|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||1.0000
73986667|NCT00843115|147518694|SUPERIORITY_OR_OTHER|||||||0.8575|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||0.8575
73986668|NCT00843115|147518695|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||1.0000
73986669|NCT00843115|147518696|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||1.0000
73986670|NCT00843115|147518697|SUPERIORITY_OR_OTHER|||||||0.0131|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||0.0131
73986671|NCT00843115|147518698|SUPERIORITY_OR_OTHER|||||||0.0078|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||0.0078
73986672|NCT01037413|147518699|SUPERIORITY||Mean Difference (Final Values)|-14.7|||<|0.001|TWO_SIDED|95.0|-21.3|-8.1|||t-test, 2 sided|||Comparison within the participant between EXC 001 and placebo.||-8.1|-21.3|<0.001
73986673|NCT01037413|147518700|SUPERIORITY||Mean Difference (Final Values)|-14.8|||<|0.001|TWO_SIDED|95.0|-21.2|-8.3|||t-test, 2 sided|||Week 8: Comparison within the participant between EXC 001 and placebo.||-8.3|-21.2|<0.001
73986674|NCT01037413|147518700|SUPERIORITY||Mean Difference (Final Values)|-26.0|||<|0.001|TWO_SIDED|95.0|-34.3|-17.7|||t-test, 2 sided|||Week 24: Comparison within the participant between EXC 001 and placebo.||-17.7|-34.3|<0.001
73986675|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.033|TWO_SIDED|95.0|-2.3|-0.1|||t-test, 2 sided|||Week 12, Vascularity: Comparison within the participant between EXC 001 and placebo.||-0.1|-2.3|0.033
73986676|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.003|TWO_SIDED|95.0|-1.9|-0.4|||t-test, 2 sided|||Week 12, Pigmentation: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.9|0.003
73986677|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.5|-0.8|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-2.5|<0.001
73986678|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|-2.7|-1.0|||t-test, 2 sided|||Week 12, Relief: Comparison within the participant between EXC 001 and placebo.||-1.0|-2.7|<0.001
73986679|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.012|TWO_SIDED|95.0|-1.9|-0.3|||t-test, 2 sided|||Week 12, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.3|-1.9|0.012
73986680|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.003|TWO_SIDED|95.0|-2.4|-0.5|||t-test, 2 sided|||Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo.||-0.5|-2.4|0.003
73986681|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.6|-1.1|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-1.1|-2.6|<0.001
73986682|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-8.4|||<|0.001|TWO_SIDED|95.0|-12.7|-4.0|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||-4.0|-12.7|<0.001
73986683|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.2|-1.4|||t-test, 2 sided|||Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo.||-1.4|-3.2|<0.001
73986684|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.9|-0.9|||t-test, 2 sided|||Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo.||-0.9|-2.9|<0.001
73986685|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.001|TWO_SIDED|95.0|-2.8|-0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-2.8|0.001
73986686|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.6|-1.3|||t-test, 2 sided|||Week 24, Relief: Comparison within the participant between EXC 001 and placebo.||-1.3|-3.6|<0.001
73986687|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.005|TWO_SIDED|95.0|-3.2|-0.7|||t-test, 2 sided|||Week 24, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.7|-3.2|0.005
73986688|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-3.1|-1.2|||t-test, 2 sided|||Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo.||-1.2|-3.1|<0.001
73986689|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.3|-1.5|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-1.5|-3.3|<0.001
73986690|NCT01037413|147518701|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED|95.0|-17.7|-7.4|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||-7.4|-17.7|<0.001
73986691|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.067|TWO_SIDED|95.0|-1.3|0.0|||t-test, 2 sided|||Week 12 Pain: Comparison within the participant between EXC 001 and placebo.||0.0|-1.3|0.067
73986692|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.413|TWO_SIDED|95.0|-1.2|0.5|||t-test, 2 sided|||Week 12, Itching: Comparison within the participant between EXC 001 and placebo.||0.5|-1.2|0.413
73986693|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.401|TWO_SIDED|95.0|-1.6|0.7|||t-test, 2 sided|||Week 12, Color: Comparison within the participant between EXC 001 and placebo.||0.7|-1.6|0.401
74034737|NCT02435277|147621957|OTHER|||||||0.26||||||Total daily dose is twice the respective dose Pairwise Comparison using Treatment D as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of Fssting Plasma Glucose change from day 1-day 84 in Evaluable Population (n=43)||||0.26
73986694|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.083|TWO_SIDED|95.0|-2.4|0.2|||t-test, 2 sided|||Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.2|-2.4|0.083
73986695|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.052|TWO_SIDED|95.0|-2.3|0.0|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||0.0|-2.3|0.052
73986696|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.036|TWO_SIDED|95.0|-2.3|-0.1|||t-test, 2 sided|||Week 12, Irregular: Comparison within the participant between EXC 001 and placebo.||-0.1|-2.3|0.036
73986697|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.045|TWO_SIDED|95.0|-2.1|0.0|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.0|-2.1|0.045
73986698|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.054|TWO_SIDED|95.0|-9.9|0.1|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||0.1|-9.9|0.054
73986699|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.065|TWO_SIDED|95.0|-8.2|0.3|||t-test, 2 sided|||Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||0.3|-8.2|0.065
73986700|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.079|TWO_SIDED|95.0|-2.0|0.1|||t-test, 2 sided|||Week 24, Pain: Comparison within the participant between EXC 001 and placebo.||0.1|-2.0|0.079
73986701|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.158|TWO_SIDED|95.0|-1.5|0.3|||t-test, 2 sided|||Week 24, Itching: Comparison within the participant between EXC 001 and placebo.||0.3|-1.5|0.158
74034738|NCT02435277|147621957|OTHER|||||||0.0083|||||||ANCOVA|||||||0.0083
73986702|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.01|TWO_SIDED|95.0|-3.0|-0.5|||t-test, 2 sided|||Week 24, Color: Comparison within the participant between EXC 001 and placebo.||-0.5|-3.0|0.010
73986703|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.003|TWO_SIDED|95.0|-3.5|-0.8|||t-test, 2 sided|||Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo.||-0.8|-3.5|0.003
73986704|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.005|TWO_SIDED|95.0|-4.0|-0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-4.0|0.005
73986705|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.032|TWO_SIDED|95.0|-3.5|-0.2|||t-test, 2 sided|||Week 24, Irregular: Comparison within the participant between EXC 001 and placebo.||-0.2|-3.5|0.032
73986706|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.003|TWO_SIDED|95.0|-3.8|-0.9|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.9|-3.8|0.003
73986707|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.006|TWO_SIDED|95.0|-16.4|-3.1|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||-3.1|-16.4|0.006
73986708|NCT01037413|147518702|SUPERIORITY||Mean Difference (Final Values)|-8.2||||0.004|TWO_SIDED|95.0|-13.4|-3.0|||t-test, 2 sided|||Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||-3.0|-13.4|0.004
73986709|NCT05215418|147518709|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.|||||<|0.001|||||||ANCOVA|||||||< 0.001
73986710|NCT05215418|147518709|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0059|||||||ANCOVA|||||||0.0059
73986711|NCT05215418|147518709|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.1867|||||||ANCOVA|||||||0.1867
73986712|NCT05215418|147518710|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0277|||||||ANCOVA|||||||0.0277
73986713|NCT05215418|147518710|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0852|||||||ANCOVA|||||||0.0852
73986714|NCT05215418|147518710|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.|||||<|0.0001|||||||ANCOVA|||||||<.0001
74034739|NCT02435277|147621957|OTHER|||||||0.0317|||||||ANCOVA|||||||0.0317
73986715|NCT05215418|147518711|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0109|||||||ANCOVA|||In-clinic systolic blood pressure||||0.0109
73986716|NCT05215418|147518711|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0339|||||||ANCOVA|||In-clinic systolic blood pressure||||0.0339
73986717|NCT05215418|147518711|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.6769|||||||ANCOVA|||In-clinic systolic blood pressure||||0.6769
73986718|NCT05215418|147518711|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0082|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.0082
73986719|NCT05215418|147518711|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.8131|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.8131
73986720|NCT05215418|147518711|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.015|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.0150
73986721|NCT00619983|147518712|SUPERIORITY|||||||0.69|||||||ANOVA|Repeated measures ANOVA||Due to failure of daily electronic diaries and exhaustion of funds, we were only able to recruit \< 30% of the number of subjects required in our power analysis.||||0.69
73986722|NCT02853305|147518748|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0033|TWO_SIDED|95.0|0.65|0.93|||Stratified Log-Rank|The treatment difference in PFS was assessed by the stratified log-rank test.||PFS in all participants of the pembro combo arm was compared to PFS in all participants of the chemo arm to address the first primary hypothesis (superiority to chemo). The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||0.93|0.65|0.0033
73986723|NCT02853305|147518749|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0407|TWO_SIDED|95.0|0.72|1.02|||Stratified Log-Rank|The treatment difference in OS was assessed by the stratified log-rank test.||OS in all participants of the pembro combo arm was compared to OS in all participants of the chemo arm to address the second primary hypothesis (superiority to chemo). The HR and its 95% CI were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.02|0.72|0.0407
73986724|NCT02853305|147518750|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.77|1.32||No formal hypothesis testing was performed.||||OS in CPS≥10 participants of the pembro arm was compared to OS in CPS≥10 participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) at baseline.||1.32|0.77|
73986725|NCT02853305|147518751|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.11||No formal hypothesis testing was performed.||||OS in all participants of the pembro arm was compared to OS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.11|0.77|
73986726|NCT02853305|147518752|OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|1.09|1.58||No formal hypothesis testing was performed.||||PFS in all participants of the pembro arm was compared to PFS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.58|1.09|
73986727|NCT02853305|147518755|OTHER||Difference in Percentage|9.8|||||TWO_SIDED|95.0|2.4|17.1||No formal hypothesis testing was performed.||||ORR in participants of the pembro combo arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||17.1|2.4|
73986728|NCT02853305|147518757|OTHER||Difference in Percentage|4.5|||||TWO_SIDED|95.0|-1.6|10.6||No formal hypothesis testing was performed.||||DCR in participants of the pembro combo arm was compared to DCR in participants of the chemo arm based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||10.6|-1.6|
73986729|NCT02853305|147518758|SUPERIORITY||Difference in Percentage|-14.8|||||TWO_SIDED|95.0|-22.0|-7.4||No formal hypothesis testing was performed.||||ORR in participants of the pembro arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||-7.4|-22.0|
74039562|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9819|TWO_SIDED|95.0|0.42|2.31|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.31|0.42|0.9819
73875309|NCT03932760|147292451|OTHER|Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.|Mean estimates by time|0.016|STANDARD_ERROR_OF_MEAN|0.859||0.558|TWO_SIDED|95.0|-1.709|1.677|||Mixed Models Analysis||Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.|We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of GAD-7 between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.|"Overall test of significance for Fixed Effects. Higher GAD-7 scores signify worsened symptoms of depression.~Group VCI (AC reference): F=0.347, p=0.558~Time (Baseline as reference): F=4.973, p\<0.001~Group\*Time: F=0.417, p=0.837~Estimates for group, time, and group\*time interactions~Group:~Estimate=-0.0160 (SE=0.859) \[CI LB=-1.709, UB=1.677\]~Time:~Post: estimate=-1.780 (0.708) \[-3.173, -0.387\]~2 months: estimate=-0.615 (0.715) \[-2.023, 0.792\]~4 months: estimate=-1.416 (0.715) \[-2.824, -0.008\]~6 months: estimate=-1.625 (0.723) \[-3.049, -0.201\]~8 months: estimate=-1.542 (0.723) \[-2.966, -0.118\]~Group\*Time:~Post: estimate=-1.157 (1.214) \[-3.547, 1.232\]~2 months: estimate=-1.361 (1.210) \[-3.742, 1.019\]~4 months: estimate= 0.183 (1.209) \[-2.196, 2.562\]~6 months: estimate=-0.508 (1.223) \[-2.914, 1.898\]~8 months: estimate=-0.127 (1.220) \[-2.529, 2.275\]"|1.677|-1.709|0.558
73875310|NCT05298202|147292474|SUPERIORITY|time x treatment ANOVA||||||0.284||||||difference between treatment and control|ANOVA|||||||0.284
73875311|NCT05298202|147292475|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||||||.177
73875312|NCT05298202|147292476|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||.122
73875313|NCT05298202|147292477|SUPERIORITY|||||||0.038|||||||ANOVA|time x treatment anova||||||.038
73986730|NCT02853305|147518760|OTHER||Difference in Percentage|-28.9|||||TWO_SIDED|95.0|-35.9|-21.6||No formal hypothesis testing was performed.||||DCR in participants of the pembro arm was compared to DCR in participants of the chemo arm based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||-21.6|-35.9|
73875314|NCT05298202|147292478|SUPERIORITY|||||||0.976|||||||ANOVA|||||||.976
73875315|NCT05298202|147292479|SUPERIORITY|||||||0.747|||||||ANOVA|||||||.747
73875316|NCT01875159|147292480|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GEE gamma regression models|||\>80% probability of detecting at least a 36% reduction in intermittent hypoxia events/hour of recording and in sec/hour \<90% oxygen saturation/hour of recording||||<0.05
73875317|NCT01389882|147292482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.007|STANDARD_DEVIATION|2.015||0.043|TWO_SIDED|95.0|0.036|1.978|||Paired t-test|||||1.978|0.036|0.043
73875318|NCT01389882|147292483|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.232|STANDARD_DEVIATION|0.841||0.245|TWO_SIDED|95.0|-0.637|0.174|||Paired t-test|||||0.174|-0.637|0.245
73875319|NCT01389882|147292484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_DEVIATION|0.095||0.257|TWO_SIDED|95.0|-0.02|0.714|||Paired t-test|||||0.714|-0.020|0.257
73875320|NCT01389882|147292485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_DEVIATION|1.541||0.601|TWO_SIDED|95.0|-0.554|0.931|||Paired t-test|||||0.931|-0.554|0.601
73875321|NCT01389882|147292486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_DEVIATION|0.355||0.085|TWO_SIDED|95.0|-0.32|0.023|||Paired t-test|||||0.023|-0.320|0.085
73986731|NCT02853305|147518764|OTHER||Difference in LS Means|2.68|||||TWO_SIDED|95.0|-0.76|6.12||No formal hypothesis testing was performed.||||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy \[cisplatin or carboplatin\] and PD-L1 status \[CPS\<10 vs. CPS≥10\]) at baseline as covariates.||6.12|-0.76|
73986732|NCT02853305|147518765|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.62|1.0||No formal hypothesis testing was performed.||||TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.00|0.62|
73986733|NCT02853305|147518766|OTHER||Difference in LS Means|-0.94|||||TWO_SIDED|95.0|-5.06|3.18||No formal hypothesis testing was performed.||||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on cLDA model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy \[cisplatin or carboplatin\] and PD-L1 status \[CPS\<10 vs. CPS≥10\]) at baseline as covariates.||3.18|-5.06|
73875322|NCT01389882|147292487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.516|STANDARD_DEVIATION|9.786||0.002|TWO_SIDED|95.0|1.799|11.232|||Wilcoxon signed-rank test|||||11.232|1.799|0.002
73875323|NCT01389882|147292488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_DEVIATION|2.516||0.009|TWO_SIDED|95.0|0.478|2.904|||Paired t-test, 2-sided|||||2.904|0.478|0.009
73875324|NCT01389882|147292489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.692|STANDARD_DEVIATION|2.192||0.314|TWO_SIDED|95.0|-0.364|1.749|||Wilcoxon signed-rank test|||||1.749|-0.364|0.314
73875325|NCT01389882|147292490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_DEVIATION|0.047||0.515|TWO_SIDED|95.0|-0.03|0.016|||Paired t-test|||||0.016|-0.030|0.515
73875326|NCT01389882|147292491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1105|STANDARD_DEVIATION|7.501||0.949|TWO_SIDED|95.0|-3.505|3.726|||Paired t-test|||||3.726|-3.505|0.949
73875327|NCT01389882|147292492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_DEVIATION|12.081||0.709|TWO_SIDED|95.0|-4.77|6.875|||Paired t-test|||||6.875|-4.770|0.709
73875328|NCT01389882|147292493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.274|STANDARD_DEVIATION|2.233||0.6|TWO_SIDED|95.0|-1.35|0.802|||Paired t-test|||||0.802|-1.350|0.600
73875329|NCT00754377|147292528|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
74034740|NCT03675737|147621988|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.7|0.87||One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||0.87|0.70|<0.0001
74034741|NCT03675737|147621989|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.65|0.84||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.84|0.65|<0.0001
74034742|NCT03675737|147621990|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.79||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.79|0.53|<0.0001
74034743|NCT03675737|147621991|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.67|0.85||One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||0.85|0.67|<0.0001
73986734|NCT02853305|147518767|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.93|1.49||No formal hypothesis testing was performed.||||TTD in GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.49|0.93|
73986735|NCT01947153|147518768|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|102.92|STANDARD_ERROR_OF_MEAN|1.027|<|0.0001|TWO_SIDED|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||107.688|98.370|<0.0001
73986736|NCT01947153|147518769|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|105.14|STANDARD_ERROR_OF_MEAN|1.032|<|0.0001|TWO_SIDED|90.0|99.645|110.941||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||110.941|99.645|<0.0001
74034744|NCT03675737|147621992|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.63|0.82||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.82|0.63|<0.0001
74034745|NCT03675737|147621993|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.76||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.76|0.51|<0.0001
74034746|NCT03675737|147621994|SUPERIORITY||Difference in Percentage|9.3||||9e-05|TWO_SIDED|95.0|4.4|14.1||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||14.1|4.4|0.00009
74034747|NCT03675737|147621995|SUPERIORITY||Difference in Percentage|9.5||||0.00041|TWO_SIDED|95.0|3.9|15.0||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|||15.0|3.9|0.00041
74034748|NCT03675737|147621996|SUPERIORITY||Difference in Percentage|17.5||||2e-05|TWO_SIDED|95.0|9.3|25.5||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|||25.5|9.3|0.00002
74034749|NCT02922634|147622031|SUPERIORITY|||||||0.508|||||||Wilcoxon (Mann-Whitney)|||||||0.508
74034750|NCT02922634|147622032|SUPERIORITY|||||||0.72||||||The chi-squared test for both males and females with and without delirium.|Chi-squared|||||||0.720
73875330|NCT00754377|147292529|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
73986737|NCT01947153|147518770|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|109.05|STANDARD_ERROR_OF_MEAN|1.063||0.0014|TWO_SIDED|90.0|98.299|120.968||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||120.968|98.299|0.0014
73986738|NCT01947153|147518771|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|105.81|STANDARD_ERROR_OF_MEAN|1.043|<|0.0001|TWO_SIDED|90.0|98.471|113.692||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||113.692|98.471|<0.0001
74034751|NCT02922634|147622033|SUPERIORITY|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
74034752|NCT02922634|147622034|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.480
74034753|NCT02922634|147622035|SUPERIORITY|||||||0.028|||||||Chi-squared|||||||0.028
74034754|NCT02922634|147622036|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
74034755|NCT02922634|147622037|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
74034756|NCT02922634|147622038|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
73875331|NCT01276639|147292531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.46|||<|0.0001|TWO_SIDED|95.0|4.4|15.03||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||15.03|4.40|<0.0001
73875332|NCT01276639|147292531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.45|||<|0.0001|TWO_SIDED|95.0|9.01|31.88||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||31.88|9.01|<0.0001
73875333|NCT01276639|147292531|SUPERIORITY_OR_OTHER||Percent difference|17.29|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|10.11|24.47|||Normal approximation|||||24.47|10.11|<0.0001
73986739|NCT01947153|147518772|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.48|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.177|105.208||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||105.208|92.177|<0.0001
73986740|NCT01947153|147518773|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|104.62|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.274|110.254||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||110.254|99.274|<0.0001
73986741|NCT01947153|147518774|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|102.92|STANDARD_ERROR_OF_MEAN|1.027|<|0.0001|TWO_SIDED|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||107.688|98.370|<0.0001
73986742|NCT01287416|147518775|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of SIRI scores across the three time points. We used linear mixed models to determine whether scores were different between the two groups over time.||||0.61
73986743|NCT01287416|147518776|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.||||0.95
74034757|NCT02922634|147622039|SUPERIORITY|||||||0.101|||||||Chi-squared|||||||0.101
74034758|NCT02922634|147622040|SUPERIORITY|||||||0.192|||||||Chi-squared|||||||0.192
74034759|NCT02922634|147622041|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.200
73986744|NCT01287416|147518777|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in terms of self-reported skill level across the three time points.||||0.33
73986745|NCT01287416|147518778|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.05.|Mixed Models Analysis|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.||||0.03
73986746|NCT01287416|147518779|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ on level of self-reported preparedness to help a suicidal person.||||0.63
74034760|NCT02922634|147622042|SUPERIORITY|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||||||0.333
74034761|NCT02922634|147622043|SUPERIORITY|||||||0.001||||||This is a chi-squared test between the FRAIL categories for participants with or without delirium.|Chi-squared|||||||0.001
74034762|NCT02922634|147622044|SUPERIORITY|||||||0.002||||||This is a chi-squared test of the categories for levels of invasiveness for participants with or without delirium.|Chi-squared|||||||0.002
74034763|NCT00762372|147622073|NON_INFERIORITY|Time to extubation = treatment group + surgical site +surgery time|Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-6.6|-2.7||||||||-2.7|-6.6|
74034764|NCT00762372|147622074|NON_INFERIORITY|"Adjusted means of time from the end of study drug inhalation to extubation in the BLM-240 N2O group and sevoflurane group, which were obtained by analysis of covariance with surgical site and surgery time as covariates, were used to verify the non-inferiority of BLM-240 to the comparator sevoflurane, with a delta = 1.0 (minute) and significance level alpha = 2.5% (one-sided)."||||||0.15|||||||t-test, 2 sided|||||||0.1500
74034765|NCT00762372|147622075|NON_INFERIORITY|Two-sample t-test||||||0.0001|||||||t-test, 2 sided|||||||0.0001
74034766|NCT00762372|147622079|NON_INFERIORITY|Fisher's exact test||||||0.3113|||||||Fisher Exact|||||||0.3113
74034767|NCT00762372|147622081|NON_INFERIORITY|Fisher's exact test||||||1|||||||Fisher Exact|||||||1.0000
74034768|NCT03364335|147622085|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5461|||||||ANCOVA|||||||0.5461
73986747|NCT01287416|147518780|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||A priori threshold for significance set to p\<.05.|ANCOVA|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ on their level of distress across the two time points.||||0.21
74034769|NCT03364335|147622085|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0364|||||||ANCOVA|||||||0.0364
73986748|NCT01287416|147518781|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||A priori threshold for significance set at p\<.05.|ANCOVA|Model was adjusted for differences in educational attainment at baseline.||Null hypothesis was that the groups would not differ in terms of alcohol use across the two time points.||||0.46
73986749|NCT01287416|147518782|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||The a priori threshold for statistical significance was set at p\<.05.|ANCOVA|Model is adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in resiliency scores across the follow-up period.||||0.28
73986750|NCT01287416|147518783|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|||||||0.33
73986751|NCT01287416|147518784|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|||||||0.62
73986752|NCT01287416|147518785|SUPERIORITY_OR_OTHER|||||||1||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||1.00
73986753|NCT01287416|147518786|SUPERIORITY_OR_OTHER|||||||1||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||1.00
73986754|NCT01287416|147518787|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||0.064
73986755|NCT01287416|147518789|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||a priori threshold for significance set a p\<.05.|Fisher Exact|unadjusted model||Null hypothesis was that the groups would not differ in terms of their gatekeeper behaviours||||0.14
73986756|NCT01287416|147518790|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|Unadjusted model||Null hypothesis was that the groups would not differ on gatekeeper behaviours.||||0.41
73986757|NCT05401149|147518823|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|1.87|||<|0.001|TWO_SIDED|95.0|1.35|2.59|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.59|1.35|<0.001
73986758|NCT05401149|147518824|OTHER|OR (95% CI) and P values were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|1.43||||0.054|TWO_SIDED|95.0|0.99|2.06|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.06|0.99|0.054
73986759|NCT05401149|147518825|OTHER|OR (95% CI) and P values were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|2.07||||0.097|TWO_SIDED|95.0|0.88|4.86|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||4.86|0.88|0.097
73986760|NCT05401149|147518826|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.48|2.75|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.75|1.48|<0.001
73986761|NCT05401149|147518827|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the ordinal logistic regression models with adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|0.77||||0.007|TWO_SIDED|95.0|0.64|0.93|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||0.93|0.64|0.007
73986762|NCT05401149|147518828|OTHER|Hazard ratio (HR) (95% Confidence Interval) and P values were derived from the cox proportional hazards models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Hazard Ratio (HR)|1.26||||0.077|TWO_SIDED|95.0|0.98|1.64|||Regression, Cox||IV rt-PA cohort/Non-reperfusion cohort|||1.64|0.98|0.077
73986763|NCT02264353|147518847|SUPERIORITY|||||||0.576|||||||t-test, 2 sided|||||||0.576
73986764|NCT02264353|147518848|OTHER|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||||||0.394
73986765|NCT02264353|147518849|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
73986766|NCT02864147|147518853|SUPERIORITY|||||||0.043||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.043
74034770|NCT03364335|147622085|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0156|||||||ANCOVA|||||||0.0156
73986767|NCT02864147|147518853|SUPERIORITY|||||||0.384||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.384
73986768|NCT02864147|147518854|SUPERIORITY|||||||0.177||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.177
73986769|NCT02864147|147518854|SUPERIORITY|||||||0.592||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.592
73986770|NCT02269917|147518855|NON_INFERIORITY|4|Difference in percentage|0.4|||<|0.001|TWO_SIDED|95.0|-1.5|2.2|||Stratum-adjusted Mantel-Haenszel (MH)|||||2.2|-1.5|<0.001
73986771|NCT02269917|147518860|OTHER||Least Square (LS) Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.623|=|0.58|TWO_SIDED|95.0|-0.88|1.57|||ANCOVA|||Change at Week 24||1.57|-0.88|=0.580
73986772|NCT02269917|147518860|OTHER||Least Square (LS) Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.646|=|0.34|TWO_SIDED|95.0|-0.65|1.88|||ANCOVA|||Change at Week 48||1.88|-0.65|=0.340
73986773|NCT02269917|147518861|OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.874|=|0.506|TWO_SIDED|95.0|-2.3|1.13|||ANCOVA|||Change at Week 24||1.13|-2.30|=0.506
73986774|NCT02269917|147518861|OTHER||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.862|=|0.392|TWO_SIDED|95.0|-2.43|0.95|||ANCOVA|||Change Week 48||0.95|-2.43|=0.392
73986775|NCT02269917|147518862|OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.624|=|0.143|TWO_SIDED|95.0|-2.14|0.31|||ANCOVA|||Change at Week 24||0.31|-2.14|=0.143
73986776|NCT02269917|147518862|OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.646|=|0.092|TWO_SIDED|95.0|-2.36|0.18|||ANCOVA|||Change at Week 48||0.18|-2.36|=0.092
73986777|NCT02269917|147518863|OTHER||LS Mean Difference|1.14|STANDARD_ERROR_OF_MEAN|0.59|=|0.054|TWO_SIDED|95.0|-0.02|2.29|||ANCOVA|||Change at Week 24||2.29|-0.02|=0.054
73986778|NCT02269917|147518863|OTHER||LS Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.63|=|0.034|TWO_SIDED|95.0|0.1|2.57|||ANCOVA|||Change at Week 48||2.57|0.10|=0.034
73986779|NCT02269917|147518864|OTHER||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 24||||<0.001
73986780|NCT02269917|147518864|OTHER||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 48||||<0.001
73986781|NCT02269917|147518864|OTHER||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 24||||<0.001
73986782|NCT02269917|147518864|OTHER||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 48||||<0.001
73986783|NCT02269917|147518865|OTHER||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 24||||<0.001
73986784|NCT02269917|147518865|OTHER||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 48||||<0.001
73986785|NCT02269917|147518865|OTHER||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 24||||<0.001
73986786|NCT02269917|147518865|OTHER||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 48||||<0.001
73986787|NCT02269917|147518866|OTHER||||||=|0.288|||||||Van Elteren Test|||FEPO4 - Change at Week 24||||=0.288
73986788|NCT02269917|147518866|OTHER||||||=|0.148|||||||Van Elteren Test|||FEPO4 - Change at Week 48||||=0.148
73986789|NCT02269917|147518877|OTHER||LS Mean Difference|1.37|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|0.697|2.037|||ANCOVA|||Spine BMD: Percent change at Week 24||2.037|0.697|<0.001
73986790|NCT02269917|147518877|OTHER||LS Mean Difference|2.05|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|1.277|2.814|||ANCOVA|||Spine BMD: Percent change at Week 48||2.814|1.277|<0.001
73986791|NCT02269917|147518877|OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.272|=|0.001|TWO_SIDED|95.0|0.366|1.436|||ANCOVA|||Hip BMD: Percent change at Week 24||1.436|0.366|=0.001
73986792|NCT02269917|147518877|OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|1.144|2.248|||ANCOVA|||Hip BMD: Percent change at Week 48||2.248|1.144|<0.001
73986793|NCT00230971|147518940|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.6||||||95.0|-6.4|9.6|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|||9.6|-6.4|
73986794|NCT00230971|147518941|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.8||||0.001||95.0|-8.8|12.5|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|||12.5|-8.8|0.001
73986795|NCT00230971|147518942|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.7||||||95.0|-7.9|13.3|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|Group comparison of eradication + presumed eradication||13.3|-7.9|
73986796|NCT00230971|147518943|SUPERIORITY_OR_OTHER|||||||0.75|||||||ANOVA|Treatment as a factor||Overall inpatient hospitalization||||0.750
73986797|NCT00230971|147518943|SUPERIORITY_OR_OTHER|||||||0.655|||||||ANOVA|Treatment as a factor||Primary inpatient hospitalization||||0.655
73986798|NCT00230971|147518943|SUPERIORITY_OR_OTHER|||||||0.191|||||||ANOVA|Treatment as a factor||ICU treatment||||0.191
73986799|NCT00230971|147518943|SUPERIORITY_OR_OTHER|||||||0.717|||||||ANOVA|Treatment as a factor||Inpatient hospitalization, non-ICU||||0.717
73986800|NCT01772147|147518952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|||<|0.001|TWO_SIDED|95.0|0.089|0.164|||Mixed Models Analysis|||||0.164|0.089|<0.001
73986801|NCT01772147|147518952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.148|||<|0.001|TWO_SIDED|95.0|0.111|0.185|||Mixed Models Analysis|||||0.185|0.111|<0.001
73986802|NCT04572997|147518965|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed-rank test||||||< 0.0001
73986803|NCT04572997|147518970|OTHER||||||<|0.001|||||||Wilcoxon Signed-rank test|||||||< 0.001
73986804|NCT03443063|147518977|OTHER||Percent (%) ratio of geometric means|104.83|||||TWO_SIDED|90.0|77.41|141.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||141.97|77.41|
73986805|NCT03443063|147518978|OTHER||Percent (%) ratio of geometric means|133.03|||||TWO_SIDED|90.0|107.3|164.93|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||164.93|107.30|
73986806|NCT03443063|147518979|OTHER||Percent (%) ratio of geometric means|150.53|||||TWO_SIDED|90.0|113.16|200.26|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||200.26|113.16|
73986807|NCT03443063|147518980|OTHER||Percent (%) ratio of geometric means|149.84|||||TWO_SIDED|90.0|113.06|198.58|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||198.58|113.06|
73986808|NCT03443063|147518981|OTHER||Percent (%) ratio of geometric means|80.09|||||TWO_SIDED|90.0|56.07|114.4|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||114.40|56.07|
73875334|NCT01276639|147292532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.93|||<|0.0001|TWO_SIDED|95.0|5.25|21.84||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||21.84|5.25|<0.0001
73875335|NCT01276639|147292532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.81|||<|0.0001|TWO_SIDED|95.0|11.9|49.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||49.86|11.90|<0.0001
73986809|NCT03443063|147518981|OTHER||Percent (%) ratio of geometric means|79.51|||||TWO_SIDED|90.0|54.48|116.03|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||116.03|54.48|
73986810|NCT03443063|147518981|OTHER||Percent (%) ratio of geometric means|72.49|||||TWO_SIDED|90.0|48.08|109.29|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||109.29|48.08|
73986811|NCT03443063|147518983|OTHER||Percent (%) ratio of geometric mean|111.25|||||TWO_SIDED|90.0|91.69|134.99|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Lemborexant||134.99|91.69|
73986812|NCT03443063|147518983|OTHER||Percent (%) ratio of geometric means|80.28|||||TWO_SIDED|90.0|56.81|113.46|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||113.46|56.81|
73986813|NCT03443063|147518983|OTHER||Percent (%) ratio of geometric means|86.71|||||TWO_SIDED|90.0|64.92|115.81|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||115.81|64.92|
73986814|NCT03443063|147518983|OTHER||Percent (%) ratio of geometric means|65.38|||||TWO_SIDED|90.0|41.08|104.04|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||104.04|41.08|
73986815|NCT03443063|147518984|OTHER||Percent (%) ratio of geometric means|114.69|||||TWO_SIDED|90.0|94.45|139.28|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||139.28|94.45|
73986816|NCT03443063|147518984|OTHER||Percent (%) ratio of geometric means|124.94|||||TWO_SIDED|90.0|100.27|155.67|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||155.67|100.27|
74034771|NCT03364335|147622085|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0349|||||||ANCOVA|||||||0.0349
74034772|NCT03364335|147622086|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5348|||||||ANCOVA|||||||0.5348
74034773|NCT03364335|147622086|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0379|||||||ANCOVA|||||||0.0379
73986817|NCT03443063|147518984|OTHER||Percent (%) ratio of geometric means|92.05|||||TWO_SIDED|90.0|66.87|126.71|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||126.71|66.87|
73986818|NCT03443063|147518985|OTHER||Percent (%) ratio of geometric means|136.28|||||TWO_SIDED|90.0|105.62|175.85|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||175.85|105.62|
74034774|NCT03364335|147622086|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0215|||||||ANCOVA|||||||0.0215
74034775|NCT03364335|147622086|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0464|||||||ANCOVA|||||||0.0464
74034776|NCT03364335|147622087|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||1|||||||Chi-squared|||||||1.0000
74034777|NCT03364335|147622087|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.2646|||||||Chi-squared|||||||0.2646
74034778|NCT03364335|147622087|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.0749|||||||Chi-squared|||||||0.0749
74034779|NCT03364335|147622087|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.6758|||||||Chi-squared|||||||0.6758
74034780|NCT03364335|147622088|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.9656|||||||ANCOVA|||||||0.9656
73875336|NCT01276639|147292532|SUPERIORITY_OR_OTHER||Percent difference|19.22|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|12.07|26.37|||Normal approximation|||||26.37|12.07|<0.0001
73986819|NCT03443063|147518985|OTHER||Percent (%) ratio of geometric means|154.29|||||TWO_SIDED|90.0|117.53|202.57|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||202.57|117.53|
74034781|NCT03364335|147622088|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.4254|||||||ANCOVA|||||||0.4254
74034782|NCT03364335|147622088|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.1276|||||||ANCOVA|||||||0.1276
74034783|NCT03364335|147622088|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.5937|||||||ANCOVA|||||||0.5937
74034784|NCT03364335|147622089|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.601|||||||ANCOVA|||||||0.6010
74034785|NCT03364335|147622089|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6513|||||||ANCOVA|||||||0.6513
74034786|NCT03364335|147622089|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4354|||||||ANCOVA|||||||0.4354
74034787|NCT03364335|147622089|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.031|||||||ANCOVA|||||||0.0310
74034788|NCT03364335|147622090|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4644|||||||ANCOVA|||||||0.4644
74034789|NCT03364335|147622090|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8573|||||||ANCOVA|||||||0.8573
73986820|NCT03443063|147518985|OTHER||Percent (%) ratio of geometric means|118.54|||||TWO_SIDED|90.0|87.84|159.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||159.97|87.84|
73986821|NCT03443063|147518986|OTHER||Percent (%) ratio of geometric means|138.62|||||TWO_SIDED|90.0|109.1|176.14|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||176.14|109.10|
73986822|NCT03443063|147518986|OTHER||Percent (%) ratio of geometric means|147.03|||||TWO_SIDED|90.0|109.06|198.22|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||198.22|109.06|
73986823|NCT03443063|147518986|OTHER||Percent (%) ratio of geometric means|136.42|||||TWO_SIDED|90.0|98.19|189.54|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||189.54|98.19|
74034790|NCT03364335|147622090|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8167|||||||ANCOVA|||||||0.8167
73986824|NCT03443063|147518987|OTHER||Percent (%) ratio of geometric means|141.07|||||TWO_SIDED|90.0|103.79|191.73|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Lemborexant||191.73|103.79|
73986825|NCT03443063|147518987|OTHER||Percent (%) ratio of geometric means|124.48|||||TWO_SIDED|90.0|100.58|154.06|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||154.06|100.58|
73986826|NCT03443063|147518987|OTHER||Percent (%) ratio of geometric means|143.31|||||TWO_SIDED|90.0|107.72|190.65|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||190.65|107.72|
73986827|NCT03443063|147518987|OTHER||Percent (%) ratio of geometric means|140.2|||||TWO_SIDED|90.0|98.11|200.35|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||200.35|98.11|
73986828|NCT00552513|147519000|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.15|TWO_SIDED|95.0|0.68|1.06|||Regression, Logistic|||||1.06|0.68|0.15
74034791|NCT03364335|147622090|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.9223|||||||ANCOVA|||||||0.9223
74034792|NCT03364335|147622091|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6574|||||||ANCOVA|||||||0.6574
74034793|NCT03364335|147622091|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8971|||||||ANCOVA|||||||0.8971
73986829|NCT00552513|147519001|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.003|TWO_SIDED|95.0|0.58|0.89|||Regression, Logistic|||||0.89|0.58|0.003
73986830|NCT00552513|147519002|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.04|TWO_SIDED|95.0|0.71|0.99|||Regression, Logistic|||||0.99|0.71|0.04
73986831|NCT01699698|147519038|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73986832|NCT01990313|147519060|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||||||0.038
73986833|NCT03511378|147519062|NON_INFERIORITY|Non-inferiority was assessed using a margin of -0.10|Difference in proportions|-0.0296||||0.007|ONE_SIDED|95.0|-0.076||||Difference in proportion|Binomial proportion used to present difference in proportion in treatments||Analysis population : ITT|||-0.076|0.007
73986834|NCT03511378|147519063|NON_INFERIORITY|Noninferiority is assessed using a margin of 10 percentage points.|Difference in proportions|0.0145|||<|0.001|ONE_SIDED|95.0|-0.0092||||Difference in proportion||Difference of proportion analysed with one sided 95% confidence interval|Analysis population: ITT|||-0.0092|<0.001
73986835|NCT00510198|147519096|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0||||The log-rank test was conducted at an alpha level of 0.05. The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Log Rank|||This is a log-rank test, which uses the time from randomization to first composite endpoint event to compare the risk of event between Access and Control arms.||||0.23
73986836|NCT00510198|147519097|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 7.5%|Risk Difference (RD)|4.7||||0.36|TWO_SIDED|95.0|-10.9|20.3||The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Two-sample test of proportions||The risk difference estimate is the difference between the Access Arm and Control arm.|||20.3|-10.9|0.36
73986837|NCT00637247|147519184|SUPERIORITY_OR_OTHER|||||||0.2|||||||Log Rank|||The hypothesis that survival curves were equal in the two treatment groups was tested with a one-sided logrank test at the alpha-0.2 level, one sided. The power of this test is 80% for detecting the hypothesized increase in median survival of 2.4 months for subjects in the experimental arm.||||0.2
73986838|NCT01960114|147519263|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|25.241|STANDARD_ERROR_OF_MEAN|2.8344|<|0.001|TWO_SIDED|95.0|19.669|30.813||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||30.813|19.669|<0.001
73986839|NCT01960114|147519264|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
73986840|NCT01960114|147519265|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
74034794|NCT03364335|147622091|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6317|||||||ANCOVA|||||||0.6317
74089715|NCT03545191|147732310|OTHER||LSGM ratio to placebo|0.78||||0.0002|TWO_SIDED|95.0|0.68|0.89||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||0.89|0.68|0.0002
73986841|NCT01960114|147519266|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 12 hours, but did not use rescue therapy, were censored at the time of withdrawal. Subjects not rescuing during the 12-hour study period had their time to rescue set to 12 hours and were censored.||||<0.001
74089716|NCT03545191|147732310|OTHER||LSGM ratio to placebo|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.83||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 50 mg vs placebo).||0.83|0.64|<0.0001
73986842|NCT01960114|147519267|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Used row-mean scores based on Cochran-Mantel-Haenszel test was stratified by baseline categorical pain score.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
73986843|NCT02469077|147519268|SUPERIORITY|||||||0.12|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.12
73986844|NCT02469077|147519269|SUPERIORITY|||||||0.04|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.04
73986845|NCT02469077|147519270|SUPERIORITY|||||||0.03|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.03
73986846|NCT02469077|147519271|SUPERIORITY|||||||0.17|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.17
73986847|NCT02469077|147519272|SUPERIORITY|||||||0.13|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.13
73986848|NCT02469077|147519273|SUPERIORITY|||||||0.98|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.98
73986849|NCT02469077|147519274|SUPERIORITY|||||||0.52|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.52
74034795|NCT03364335|147622091|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.0341|||||||ANCOVA|||||||0.0341
74034796|NCT03364335|147622092|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.372|||||||ANCOVA|||||||0.3720
73875337|NCT01276639|147292533|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-53.56|STANDARD_ERROR_OF_MEAN|4.34|<|0.0001|TWO_SIDED|95.0|-62.08|-45.04||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-45.04|-62.08|<0.0001
73956506|NCT00708097|147449047|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19||||0.9567|TWO_SIDED|95.0|-6.71|7.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.09|-6.71|0.9567
73986850|NCT02469077|147519275|SUPERIORITY|||||||0.65|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.65
73986851|NCT02469077|147519276|SUPERIORITY|||||||0.1|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.1
73986852|NCT02469077|147519277|SUPERIORITY|||||||0.046|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.046
73986853|NCT02469077|147519278|SUPERIORITY|||||||0.61|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.61
73986854|NCT02469077|147519279|SUPERIORITY|||||||0.4|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.4
73986855|NCT02469077|147519280|SUPERIORITY|||||||0.57|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.57
73986856|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.016|0.092|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.092|0.016|
74034797|NCT03364335|147622092|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.2302|||||||ANCOVA|||||||0.2302
73986857|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.027|0.103|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.103|0.027|
73986858|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.046|0.122|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.122|0.046|
73986859|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.027|0.049|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.049|-0.027|
74034798|NCT03364335|147622092|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.1377|||||||ANCOVA|||||||0.1377
73986860|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.008|0.069|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.069|-0.008|
73986861|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.019|0.058|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.058|-0.019|
73986862|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.013|0.089|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.089|0.013|
73986863|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.045|0.122|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.122|0.045|
73986864|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.042|0.119|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.119|0.042|
73986865|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.006|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.071|-0.006|
73986866|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.009|0.068|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.068|-0.009|
73986867|NCT01040403|147519281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.041|0.035|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.035|-0.041|
73986868|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.04|0.159|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.159|0.040|
73986869|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.061|0.179|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.179|0.061|
73986870|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.041|0.16|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.160|0.041|
73986871|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.039|0.079|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.079|-0.039|
73986872|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.059|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.061|-0.059|
73986873|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.079|0.04|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.040|-0.079|
73986874|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.071|0.19|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.190|0.071|
73956507|NCT00708097|147449047|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.81||||0.8188|TWO_SIDED|95.0|-6.14|7.76||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.76|-6.14|0.8188
73986875|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.072|0.191|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.191|0.072|
73986876|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.067|0.187|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.187|0.067|
73986877|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.059|0.061|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.061|-0.059|
73986878|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.063|0.056|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.056|-0.063|
73986879|NCT01040403|147519282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.064|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.055|-0.064|
73986880|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.035|0.114|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||0.114|0.035|
74034799|NCT03364335|147622092|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4295|||||||ANCOVA|||||||0.4295
74034800|NCT03364335|147622093|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.6726|||||||ANCOVA|||||||0.6726
73986881|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.057|0.137|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||0.137|0.057|
73986882|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.079|0.159|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||0.159|0.079|
73986883|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.017|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||0.062|-0.017|
73986884|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.021|||TWO_SIDED|95.0|0.004|0.085|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||0.085|0.004|
73986885|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.018|0.062|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||0.062|-0.018|
74034801|NCT03364335|147622093|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.7934|||||||ANCOVA|||||||0.7934
73986886|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.057|0.137|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||0.137|0.057|
73986887|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.088|0.168|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||0.168|0.088|
73986888|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.103|0.183|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||0.183|0.103|
73986889|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.009|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||0.071|-0.009|
73986890|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.006|0.086|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||0.086|0.006|
73986891|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.025|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||0.055|-0.025|
73986892|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.04|0.117|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||0.117|0.040|
73986893|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.06|0.137|||Mixed Models Analysis||difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||0.137|0.060|
73986894|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.08|0.157|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||0.157|0.080|
73986895|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.018|0.058|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||0.058|-0.018|
74034802|NCT03364335|147622093|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.5485|||||||ANCOVA|||||||0.5485
73986896|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.001|0.079|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||0.079|0.001|
73986897|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.019|0.058|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||0.058|-0.019|
73986898|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.06|0.136|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||0.136|0.060|
73875338|NCT01276639|147292533|SUPERIORITY_OR_OTHER||LS mean difference|-68.82|STANDARD_ERROR_OF_MEAN|4.34|<|0.0001|TWO_SIDED|95.0|-77.33|-60.31||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-60.31|-77.33|<0.0001
73986899|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.083|0.159|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||0.159|0.083|
73986900|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.105|0.182|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||0.182|0.105|
73986901|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.016|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||0.062|-0.016|
73986902|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.007|0.084|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||0.084|0.007|
73986903|NCT01040403|147519283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.016|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||0.061|-0.016|
73986904|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.058|0.012|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.012|-0.058|
74034803|NCT03364335|147622093|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.3676|||||||ANCOVA|||||||0.3676
73875339|NCT01276639|147292533|SUPERIORITY_OR_OTHER||LS mean difference|-15.26|STANDARD_ERROR_OF_MEAN|3.46|<|0.0001|TWO_SIDED|95.0|-22.04|-8.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-8.48|-22.04|<0.0001
73986905|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.029|0.04|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.040|-0.029|
73986906|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.034|0.036|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.036|-0.034|
73986907|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.006|0.063|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.063|-0.006|
73986908|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.011|0.059|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.059|-0.011|
73986909|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.039|0.031|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.031|-0.039|
73986910|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|0.004|0.073|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.073|0.004|
73986911|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.004|0.066|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.066|-0.004|
73986912|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|0.006|0.076|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.076|0.006|
73986913|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.043|0.027|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.027|-0.043|
73986914|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.032|0.037|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.037|-0.032|
73986915|NCT01040403|147519284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.025|0.045|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.045|-0.025|
73986916|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.041|0.138|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.138|0.041|
73986917|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|0.043|0.139|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.139|0.043|
73986918|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.066|0.164|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.164|0.066|
73986919|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.046|0.05|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.050|-0.046|
73986920|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.023|0.074|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.074|-0.023|
73986921|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.025|0.072|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.072|-0.025|
73986922|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.059|0.156|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.156|0.059|
73986923|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.084|0.181|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.181|0.084|
73875340|NCT01276639|147292534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|34.55|||<|0.0001|TWO_SIDED|95.0|7.46|1786.9||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||1786.9|7.46|<0.0001
73875341|NCT01276639|147292534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|98.05|||<|0.0001|TWO_SIDED|95.0|23.49|5689.8||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||5689.8|23.49|<0.0001
73875342|NCT01276639|147292534|SUPERIORITY_OR_OTHER||Percent difference|19.61|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|13.1|26.11|||Normal approximation|||||26.11|13.10|<0.0001
73986924|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.096|0.193|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.193|0.096|
73986925|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.024|0.074|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.074|-0.024|
73986926|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.01|0.086|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.086|-0.010|
73986927|NCT01040403|147519285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.036|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.061|-0.036|
73986928|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.059|0.02|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.020|-0.059|
73986929|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.026|0.053|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.053|-0.026|
73986930|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.028|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.051|-0.028|
73956508|NCT00708097|147449047|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.06|||<|0.0001|TWO_SIDED|95.0|-34.03|-20.08||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.08|-34.03|<0.0001
73986931|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.006|0.072|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.072|-0.006|
73986932|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.009|0.071|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.071|-0.009|
73986933|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.041|0.037|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.037|-0.041|
73986934|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.015|0.093|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.093|0.015|
73986935|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.006|0.084|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.084|0.006|
74034804|NCT03364335|147622094|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1653|||||||ANCOVA|||||||0.1653
73986936|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.008|0.087|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.087|0.008|
73986937|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.049|0.031|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.031|-0.049|
73986938|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.046|0.033|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.033|-0.046|
73986939|NCT01040403|147519286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.037|0.042|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.042|-0.037|
73986940|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.084|0.202|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||0.202|0.084|
73986941|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.092|0.21|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||0.210|0.092|
73986942|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.072|0.191|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||0.191|0.072|
73986943|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.051|0.066|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||0.066|-0.051|
74034805|NCT03364335|147622094|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.197|||||||ANCOVA|||||||0.1970
74034806|NCT03364335|147622094|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.0608|||||||ANCOVA|||||||0.0608
74034807|NCT03364335|147622094|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1583|||||||ANCOVA|||||||0.1583
74034808|NCT03364335|147622095|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.0524|||||||ANCOVA|||||||0.0524
74034809|NCT03364335|147622095|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5221|||||||ANCOVA|||||||0.5221
73956509|NCT00708097|147449047|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.62||||0.8599|TWO_SIDED|95.0|-6.28|7.51||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.51|-6.28|0.8599
74034810|NCT03364335|147622095|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3702|||||||ANCOVA|||||||0.3702
74034811|NCT03364335|147622095|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5426|||||||ANCOVA|||||||0.5426
74034812|NCT03364335|147622096|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.1843|||||||ANCOVA|||||||0.1843
74034813|NCT03364335|147622096|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.4411|||||||ANCOVA|||||||0.4411
74034814|NCT03364335|147622096|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.6991|||||||ANCOVA|||||||0.6991
74034815|NCT03364335|147622096|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3721|||||||ANCOVA|||||||0.3721
74034816|NCT03364335|147622097|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.0318|||||||ANCOVA|||||||0.0318
74034817|NCT03364335|147622097|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.3827|||||||ANCOVA|||||||0.3827
74034818|NCT03364335|147622097|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.005|||||||ANCOVA|||||||0.0050
74034819|NCT03364335|147622097|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.1045|||||||ANCOVA|||||||0.1045
74034820|NCT03987919|147622098|SUPERIORITY||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.64|-0.38|||Mixed Models Analysis|||||-0.38|-0.64|<0.001
74034821|NCT03987919|147622098|SUPERIORITY||LS Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.73|-0.47|||Mixed Models Analysis|||||-0.47|-0.73|<0.001
74034822|NCT03987919|147622099|SUPERIORITY||LS Mean Difference|-0.23|||<|0.001|TWO_SIDED|95.0|-0.36|-0.1|||Mixed Models Analysis|||||-0.10|-0.36|<0.001
74034823|NCT03987919|147622100|SUPERIORITY||LS Mean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.6|-0.7|||Mixed Models Analysis|||||-0.7|-2.6|<0.001
74034824|NCT03987919|147622100|SUPERIORITY||LS Mean Difference|-4.1|||<|0.001|TWO_SIDED|95.0|-5.0|-3.2|||Mixed Models Analysis|||||-3.2|-5.0|<0.001
74034825|NCT03987919|147622100|SUPERIORITY||LS Mean Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-7.1|-5.3|||Mixed Models Analysis|||||-5.3|-7.1|<0.001
74034826|NCT03987919|147622101|SUPERIORITY||Odds Ratio (OR)|1.54||||0.023|TWO_SIDED|95.0|1.06|2.23|||Regression, Logistic|||||2.23|1.06|0.023
74034827|NCT03987919|147622101|SUPERIORITY||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.44|3.17|||Regression, Logistic|||||3.17|1.44|<0.001
73956510|NCT00708097|147449047|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.25|||<|0.0001|TWO_SIDED|95.0|-34.2|-20.3||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.30|-34.20|<0.0001
74034828|NCT03987919|147622101|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.97|4.66|||Regression, Logistic|||||4.66|1.97|<0.001
74034829|NCT03987919|147622102|SUPERIORITY||LS Mean Difference|-7.3||||0.001|TWO_SIDED|95.0|-11.7|-3.0|||Mixed Models Analysis|||||-3.0|-11.7|0.001
74034830|NCT03987919|147622102|SUPERIORITY||LS Mean Difference|-13.0|||<|0.001|TWO_SIDED|95.0|-17.4|-8.6|||Mixed Models Analysis|||||-8.6|-17.4|<0.001
74034831|NCT03987919|147622102|SUPERIORITY||LS Mean Difference|-14.7|||<|0.001|TWO_SIDED|95.0|-19.1|-10.3|||Mixed Models Analysis|||||-10.3|-19.1|<0.001
74034832|NCT03987919|147622104|SUPERIORITY||Odds Ratio (OR)|1.58||||0.001|TWO_SIDED|95.0|1.2|2.08|||Regression, Logistic|||||2.08|1.20|0.001
74034833|NCT03987919|147622104|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|2.57|4.75|||Regression, Logistic|||||4.75|2.57|<0.001
73986944|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.071|0.048|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||0.048|-0.071|
73986945|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.079|0.039|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||0.039|-0.079|
73986946|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.116|0.234|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||0.234|0.116|
73986947|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.116|0.234|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||0.234|0.116|
73986948|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.14|0.259|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||0.259|0.140|
73986949|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.06|0.059|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||0.059|-0.060|
73986950|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.035|0.083|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||0.083|-0.035|
73986951|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.035|0.083|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||0.083|-0.035|
73986952|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.081|0.197|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||0.197|0.081|
73986953|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.092|0.207|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||0.207|0.092|
73986954|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.073|0.189|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||0.189|0.073|
73875343|NCT01276639|147292536|SUPERIORITY_OR_OTHER||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-4.75|-3.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.05|-4.75|<0.0001
73986955|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.047|0.068|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||0.068|-0.047|
74034834|NCT03987919|147622104|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|3.32|6.38|||Regression, Logistic|||||6.38|3.32|<0.001
73986956|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.066|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||0.051|-0.066|
73986957|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.076|0.039|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||0.039|-0.076|
73986958|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.131|0.247|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||0.247|0.131|
73986959|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.121|0.236|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||0.236|0.121|
73986960|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.155|0.271|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||0.271|0.155|
73986961|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.069|0.048|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||0.048|-0.069|
73986962|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.033|0.082|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||0.082|-0.033|
73986963|NCT01040403|147519287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.023|0.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||0.092|-0.023|
73986964|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.106|0.01|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.010|-0.106|
73986965|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.065|0.051|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.051|-0.065|
73986966|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.072|0.044|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.044|-0.072|
73986967|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.017|0.099|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.099|-0.017|
73986968|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.024|0.093|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.093|-0.024|
73986969|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.065|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.051|-0.065|
74034835|NCT03987919|147622105|SUPERIORITY||LS Mean Difference|-0.24||||0.084|TWO_SIDED|95.0|-0.5|0.03|||ANCOVA|||Hyperglycemia||0.03|-0.50|0.084
73875344|NCT01276639|147292536|SUPERIORITY_OR_OTHER||LS mean difference|-4.71|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-5.56|-3.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.86|-5.56|<0.0001
73875345|NCT01276639|147292536|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.35||0.0212|TWO_SIDED|95.0|-1.5|-0.12|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.12|-1.50|0.0212
73875346|NCT01276639|147292536|SUPERIORITY_OR_OTHER||LS mean difference|-4.98|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-6.02|-3.95||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.95|-6.02|<0.0001
73986970|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.032|0.148|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.148|0.032|
73986971|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.001|0.118|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.118|0.001|
73986972|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.002|0.114|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.114|-0.002|
73986973|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.089|0.028|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.028|-0.089|
73986974|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.092|0.024|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.024|-0.092|
73986975|NCT01040403|147519288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.062|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.055|-0.062|
73986976|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.087|0.223|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.223|0.087|
73986977|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.079|0.215|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.215|0.079|
73986978|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.058|0.195|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.195|0.058|
74034836|NCT03987919|147622105|SUPERIORITY||LS Mean Difference|-0.27||||0.05|TWO_SIDED|95.0|-0.54|0.0|||ANCOVA|||Hyperglycemia||0.00|-0.54|0.050
73986979|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.075|0.06|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.060|-0.075|
73986980|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.097|0.041|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.041|-0.097|
73986981|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.089|0.048|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.048|-0.089|
73986982|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.106|0.242|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.242|0.106|
73986983|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.113|0.25|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.250|0.113|
73986984|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.135|0.272|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.272|0.135|
73986985|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.061|0.076|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.076|-0.061|
73986986|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.038|0.098|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.098|-0.038|
73986987|NCT01040403|147519289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.046|0.09|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.090|-0.046|
73986988|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.114|0.013|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.013|-0.114|
73986989|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.055|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.071|-0.055|
74034837|NCT03987919|147622105|SUPERIORITY||LS Mean Difference|-0.39||||0.005|TWO_SIDED|95.0|-0.66|-0.12|||ANCOVA|||Hyperglycemia||-0.12|-0.66|0.005
74034838|NCT03987919|147622105|SUPERIORITY||LS Mean Difference|-0.06||||0.688|TWO_SIDED|95.0|-0.33|0.22|||ANCOVA|||Hypoglycemia||0.22|-0.33|0.688
74034839|NCT03987919|147622105|SUPERIORITY||LS Mean Difference|-0.02||||0.909|TWO_SIDED|95.0|-0.29|0.26|||ANCOVA|||Hypoglycemia||0.26|-0.29|0.909
73986990|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.074|0.053|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.053|-0.074|
73986991|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.004|0.122|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.122|-0.004|
73986992|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.024|0.104|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.104|-0.024|
73986993|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.082|0.045|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus +O 2.5/5|||0.045|-0.082|
73986994|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.047|0.174|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.174|0.047|
73875347|NCT01276639|147292536|SUPERIORITY_OR_OTHER||LS mean difference|-6.97|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-8.0|-5.94||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-5.94|-8.00|<0.0001
73986995|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.017|0.144|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.144|0.017|
73986996|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.005|0.132|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.132|0.005|
73986997|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.094|0.034|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.034|-0.094|
74034840|NCT03987919|147622105|SUPERIORITY||LS Mean Difference|-0.13||||0.358|TWO_SIDED|95.0|-0.4|0.15|||ANCOVA|||Hypoglycemia||0.15|-0.40|0.358
74034841|NCT03987919|147622105|SUPERIORITY||LS Mean Difference|-0.1||||0.701|TWO_SIDED|95.0|-0.62|0.41|||ANCOVA|||Total Score||0.41|-0.62|0.701
74034842|NCT03987919|147622105|SUPERIORITY||LS Mean Difference|-0.25||||0.341|TWO_SIDED|95.0|-0.78|0.27|||ANCOVA|||Total Score||0.27|-0.78|0.341
74034843|NCT03987919|147622105|SUPERIORITY||LS Mean Difference|0.26||||0.321|TWO_SIDED|95.0|-0.26|0.79|||ANCOVA|||Total Score||0.79|-0.26|0.321
74034844|NCT03987919|147622107|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.001|TWO_SIDED|95.0|1.35|2.57|||Regression, Logistic|||||2.57|1.35|<0.001
74034845|NCT03987919|147622107|SUPERIORITY||Odds Ratio (OR)|3.94|||<|0.001|TWO_SIDED|95.0|2.88|5.39|||Regression, Logistic|||||5.39|2.88|<0.001
74034846|NCT03987919|147622107|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|3.73|6.97|||Regression, Logistic|||||6.97|3.73|<0.001
74034847|NCT01194804|147622108|OTHER||||||<|0.001|||||||Sign test|||||||<0.001
74034848|NCT03621943|147622136|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.87|TWO_SIDED|95.0|-6.36|5.37|||hierarchical generalized linear mixed mo|hierarchical generalized linear mixed models||Total score on the Ages and Stages Questionnaire, 3rd ed.||5.37|-6.36|0.87
74034849|NCT00948818|147622161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||0.0004|TWO_SIDED|95.0|1.51|4.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||4.47|1.51|0.0004
74034850|NCT00948818|147622163|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.26|5.88||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||5.88|2.26|<0.0001
74034851|NCT00948818|147622164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0262|TWO_SIDED|95.0|1.04|1.91||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||1.91|1.04|0.0262
74034852|NCT00948818|147622165|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||<|0.0001|TWO_SIDED|95.0|1.4|2.66||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."||2.66|1.40|<0.0001
74034853|NCT01716533|147622175|SUPERIORITY||GMC ratio|1.53||||0.5746|TWO_SIDED|95.0|0.33|7.14||P-value = two-sided p-value for HO: GMC ratio = 1 (ANOVA model, T-test), groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA|ANOVA model -pooled variance.|GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|ELISA anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.||7.14|0.33|0.5746
74039563|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4333|TWO_SIDED|95.0|0.62|3.02|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.02|0.62|0.4333
73986998|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.105|0.021|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.021|-0.105|
73986999|NCT01040403|147519290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.075|0.052|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.052|-0.075|
73987000|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.759|STANDARD_ERROR_OF_MEAN|4.189|||TWO_SIDED|95.0|10.533|26.985|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||26.985|10.533|
73987001|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.157|STANDARD_ERROR_OF_MEAN|4.173|||TWO_SIDED|95.0|16.962|33.351|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||33.351|16.962|
73987002|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.804|STANDARD_ERROR_OF_MEAN|4.216|||TWO_SIDED|95.0|21.526|38.082|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||38.082|21.526|
73987003|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.398|STANDARD_ERROR_OF_MEAN|4.173|||TWO_SIDED|95.0|-1.796|14.592|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||14.592|-1.796|
73987004|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.046|STANDARD_ERROR_OF_MEAN|4.239|||TWO_SIDED|95.0|2.721|19.37|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||19.370|2.721|
73875348|NCT01276639|147292536|SUPERIORITY_OR_OTHER||LS mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.8|-1.17|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-1.17|-2.80|<0.0001
73875349|NCT01276639|147292537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.34|||<|0.0001|TWO_SIDED|95.0|3.23|35.12||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||35.12|3.23|<0.0001
73987005|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.648|STANDARD_ERROR_OF_MEAN|4.204|||TWO_SIDED|95.0|-3.608|12.903|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||12.903|-3.608|
73987006|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.318|STANDARD_ERROR_OF_MEAN|4.201|||TWO_SIDED|95.0|10.068|26.568|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||26.568|10.068|
73987007|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.511|STANDARD_ERROR_OF_MEAN|4.197|||TWO_SIDED|95.0|15.27|31.752|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||31.752|15.270|
73987008|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.817|STANDARD_ERROR_OF_MEAN|4.214|||TWO_SIDED|95.0|14.543|31.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||31.092|14.543|
73987009|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.193|STANDARD_ERROR_OF_MEAN|4.23|||TWO_SIDED|95.0|-3.115|13.5|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||13.500|-3.115|
73987010|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.499|STANDARD_ERROR_OF_MEAN|4.185|||TWO_SIDED|95.0|-3.719|12.717|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||12.717|-3.719|
73987011|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.694|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-8.941|7.554|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||7.554|-8.941|
73987012|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.751|STANDARD_ERROR_OF_MEAN|4.013|||TWO_SIDED|95.0|10.87|26.632|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||26.632|10.870|
73987013|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.009|STANDARD_ERROR_OF_MEAN|3.998|||TWO_SIDED|95.0|18.158|33.86|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||33.860|18.158|
73987014|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.347|STANDARD_ERROR_OF_MEAN|4.039|||TWO_SIDED|95.0|21.416|37.278|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||37.278|21.416|
73987015|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.259|STANDARD_ERROR_OF_MEAN|3.998|||TWO_SIDED|95.0|-0.592|15.109|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||15.109|-0.592|
73987016|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.596|STANDARD_ERROR_OF_MEAN|4.061|||TWO_SIDED|95.0|2.621|18.571|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||18.571|2.621|
73987017|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.337|STANDARD_ERROR_OF_MEAN|4.028|||TWO_SIDED|95.0|-4.572|11.247|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||11.247|-4.572|
73987018|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.654|STANDARD_ERROR_OF_MEAN|4.025|||TWO_SIDED|95.0|11.75|27.558|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||27.558|11.750|
73987019|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.762|STANDARD_ERROR_OF_MEAN|4.021|||TWO_SIDED|95.0|14.866|30.659|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||30.659|14.866|
74039564|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|0.91||||0.814|TWO_SIDED|95.0|0.41|2.0|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.41|0.8140
73987020|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.536|STANDARD_ERROR_OF_MEAN|4.038|||TWO_SIDED|95.0|17.607|33.464|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||33.464|17.607|
73987021|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.108|STANDARD_ERROR_OF_MEAN|4.053|||TWO_SIDED|95.0|-4.852|11.067|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||11.067|-4.852|
73987022|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.881|STANDARD_ERROR_OF_MEAN|4.009|||TWO_SIDED|95.0|-1.991|13.754|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||13.754|-1.991|
73987023|NCT01040403|147519291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.773|STANDARD_ERROR_OF_MEAN|4.024|||TWO_SIDED|95.0|-5.129|10.675|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||10.675|-5.129|
73987024|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.316|STANDARD_ERROR_OF_MEAN|4.371|||TWO_SIDED|95.0|-6.268|10.9|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||10.900|-6.268|
73987025|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.478|STANDARD_ERROR_OF_MEAN|4.362|||TWO_SIDED|95.0|-4.088|13.044|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||13.044|-4.088|
73987026|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.668|STANDARD_ERROR_OF_MEAN|4.403|||TWO_SIDED|95.0|-3.978|13.314|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||13.314|-3.978|
73987027|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.162|STANDARD_ERROR_OF_MEAN|4.349|||TWO_SIDED|95.0|-6.379|10.702|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||10.702|-6.379|
73987028|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.352|STANDARD_ERROR_OF_MEAN|4.419|||TWO_SIDED|95.0|-6.326|11.029|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||11.029|-6.326|
73987029|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|4.39|||TWO_SIDED|95.0|-8.43|8.81|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||8.810|-8.430|
73987030|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.488|STANDARD_ERROR_OF_MEAN|4.392|||TWO_SIDED|95.0|-7.136|10.113|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||10.113|-7.136|
73987031|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.262|STANDARD_ERROR_OF_MEAN|4.386|||TWO_SIDED|95.0|-5.35|11.875|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||11.875|-5.350|
73987032|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.121|STANDARD_ERROR_OF_MEAN|4.408|||TWO_SIDED|95.0|-1.535|15.778|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||15.778|-1.535|
73987033|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.774|STANDARD_ERROR_OF_MEAN|4.423|||TWO_SIDED|95.0|-6.91|10.458|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||10.458|-6.910|
73987034|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.663|STANDARD_ERROR_OF_MEAN|4.381|||TWO_SIDED|95.0|-2.97|14.236|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||14.236|-2.970|
73987035|NCT01040403|147519292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.859|STANDARD_ERROR_OF_MEAN|4.403|||TWO_SIDED|95.0|-4.786|12.504|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||12.504|-4.786|
73987036|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.682|STANDARD_ERROR_OF_MEAN|4.849|||TWO_SIDED|95.0|9.161|28.204|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||28.204|9.161|
73987037|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.599|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|14.116|33.083|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||33.083|14.116|
73987038|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.097|STANDARD_ERROR_OF_MEAN|4.879|||TWO_SIDED|95.0|20.517|39.677|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||39.677|20.517|
73987039|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.917|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|-4.568|14.402|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||14.402|-4.568|
73987040|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.415|STANDARD_ERROR_OF_MEAN|4.907|||TWO_SIDED|95.0|1.78|21.05|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||21.050|1.780|
73987041|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.498|STANDARD_ERROR_OF_MEAN|4.866|||TWO_SIDED|95.0|-3.057|16.053|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||16.053|-3.057|
73987042|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.742|STANDARD_ERROR_OF_MEAN|4.862|||TWO_SIDED|95.0|8.194|27.29|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||27.290|8.194|
73987043|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.115|STANDARD_ERROR_OF_MEAN|4.856|||TWO_SIDED|95.0|14.58|33.651|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||33.651|14.580|
73875350|NCT01276639|147292537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.53|||<|0.0001|TWO_SIDED|95.0|5.06|54.42||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||54.42|5.06|<0.0001
73875351|NCT01276639|147292537|SUPERIORITY_OR_OTHER||Percent difference|5.98|STANDARD_ERROR_OF_MEAN|2.97||0.0443|TWO_SIDED|95.0|0.15|11.8|||Normal approximation|||||11.80|0.15|0.0443
73875352|NCT01276639|147292538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.76||||0.0003|TWO_SIDED|95.0|2.11|35.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||35.77|2.11|0.0003
73875353|NCT01276639|147292538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.55|||<|0.0001|TWO_SIDED|95.0|3.64|59.98||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||59.98|3.64|<0.0001
73875354|NCT01276639|147292538|SUPERIORITY_OR_OTHER||Percent difference|5.09|STANDARD_ERROR_OF_MEAN|2.5||0.0415|TWO_SIDED|95.0|0.19|9.98|||Normal approximation|||||9.98|0.19|0.0415
73875355|NCT01276639|147292539|SUPERIORITY_OR_OTHER||LS mean difference|-69.7|STANDARD_ERROR_OF_MEAN|17.6|<|0.0001|TWO_SIDED|95.0|-104.27|-35.13||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-35.13|-104.27|<0.0001
73875356|NCT01276639|147292539|SUPERIORITY_OR_OTHER||LS mean difference|-97.03|STANDARD_ERROR_OF_MEAN|17.47|<|0.0001|TWO_SIDED|95.0|-131.35|-62.72||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-62.72|-131.35|<0.0001
73875357|NCT01276639|147292539|SUPERIORITY_OR_OTHER||LS mean difference|-27.33|STANDARD_ERROR_OF_MEAN|13.22||0.0391|TWO_SIDED|95.0|-53.29|-1.37|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-1.37|-53.29|0.0391
73987044|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.095|STANDARD_ERROR_OF_MEAN|4.876|||TWO_SIDED|95.0|15.52|34.67|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||34.670|15.520|
73987045|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.373|STANDARD_ERROR_OF_MEAN|4.896|||TWO_SIDED|95.0|-3.24|15.986|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||15.986|-3.240|
74034854|NCT01716533|147622176|SUPERIORITY|ANOVA model -pooled variance.|GMC ratio|1.65||||0.7124|TWO_SIDED|95.0|0.1|26.41||P-value = two-sided p-value for HO: GMC ratio = 1, groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA||GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|Serum F2 C-terminal anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.||26.41|0.10|0.7124
73875358|NCT01276639|147292543|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74034855|NCT01290445|147622195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.46|1.47||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.47|0.46|
73875359|NCT01276639|147292543|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73875360|NCT01276639|147292543|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73875361|NCT01276639|147292544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73987046|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.353|STANDARD_ERROR_OF_MEAN|4.845|||TWO_SIDED|95.0|-2.161|16.866|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||16.866|-2.161|
73987047|NCT01040403|147519293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|4.861|||TWO_SIDED|95.0|-8.566|10.525|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||10.525|-8.566|
73987048|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_ERROR_OF_MEAN|4.853|||TWO_SIDED|95.0|-8.36|10.699|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||10.699|-8.360|
73987049|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.436|STANDARD_ERROR_OF_MEAN|4.843|||TWO_SIDED|95.0|-5.073|13.945|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||13.945|-5.073|
73987050|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.189|STANDARD_ERROR_OF_MEAN|4.887|||TWO_SIDED|95.0|-4.407|14.785|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||14.785|-4.407|
73987051|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267|STANDARD_ERROR_OF_MEAN|4.828|||TWO_SIDED|95.0|-6.214|12.747|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||12.747|-6.214|
73987052|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.02|STANDARD_ERROR_OF_MEAN|4.904|||TWO_SIDED|95.0|-5.61|13.65|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||13.650|-5.610|
74034856|NCT01290445|147622195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.45|1.42||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.42|0.45|
74034857|NCT01290445|147622196|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.09|4.34||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||4.34|0.09|
74034858|NCT01290445|147622196|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.09|4.67||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||4.67|0.09|
74089717|NCT03179163|147732311|OTHER||Mean Difference (Net)|0.01|||=|0.01|TWO_SIDED||||||ANOVA|||A priori power analysis (power = 0.80,a= 0.05) confirmed a sample size of n= 10 was needed to determine a meaningful difference of 10% in the (flux/MAP)\*logAch(mol/L) . All data were analyzed with repeated-measures ANOVA . When appropriate, post hoc Tukey-Kramer corrections were applied to correct for multiple comparisons. Significance was set a priori at a\<0.05.||||=0.01
74089718|NCT01277718|147732314|SUPERIORITY_OR_OTHER||Ratio of Least Squares (LS) Means (in %)|111.0|||||TWO_SIDED|90.0|98.02|124.99|||||LS mean was calculated from Analysis of variance (ANOVA). Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||124.99|98.02|
73875362|NCT01276639|147292544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73875363|NCT01276639|147292544|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73875364|NCT01276639|147292545|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73987053|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.753|STANDARD_ERROR_OF_MEAN|4.873|||TWO_SIDED|95.0|-8.816|10.322|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||10.322|-8.816|
73987054|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.986|STANDARD_ERROR_OF_MEAN|4.876|||TWO_SIDED|95.0|-6.589|12.561|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||12.561|-6.589|
73987055|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.916|STANDARD_ERROR_OF_MEAN|4.868|||TWO_SIDED|95.0|-4.643|14.475|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||14.475|-4.643|
73987056|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.432|STANDARD_ERROR_OF_MEAN|4.882|||TWO_SIDED|95.0|-2.154|17.019|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||17.019|-2.154|
73987057|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93|STANDARD_ERROR_OF_MEAN|4.909|||TWO_SIDED|95.0|-7.708|11.568|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||11.568|-7.708|
73987058|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.446|STANDARD_ERROR_OF_MEAN|4.854|||TWO_SIDED|95.0|-5.085|13.978|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||13.978|-5.085|
73987059|NCT01040403|147519294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.517|STANDARD_ERROR_OF_MEAN|4.87|||TWO_SIDED|95.0|-7.046|12.079|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||12.079|-7.046|
73987060|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.212|STANDARD_ERROR_OF_MEAN|0.158|||TWO_SIDED|95.0|-0.523|0.099|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Week 1||0.099|-0.523|
73987061|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.319|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.634|-0.004|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Week 1||-0.004|-0.634|
73987062|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.379|0.249|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Week 1||0.249|-0.379|
73987063|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.107|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.42|0.206|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 1||0.206|-0.420|
73987064|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.168|0.462|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 1||0.462|-0.168|
73987065|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.255|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|95.0|-0.062|0.571|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 1||0.571|-0.062|
74034859|NCT01290445|147622197|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.5|0.96||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||0.96|0.50|
74034860|NCT01290445|147622197|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.51|0.97||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||0.97|0.51|
74034861|NCT01290445|147622198|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.63|1.42||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.42|0.63|
74034862|NCT01290445|147622198|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.61|1.37||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.37|0.61|
74034863|NCT01290445|147622199|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.37|1.16||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.16|0.37|
73987066|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.271|0.355|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Week 1||0.355|-0.271|
73987067|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.564|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Week 1||0.062|-0.564|
73987068|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.492|0.135|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Week 1||0.135|-0.492|
73987069|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-0.611|0.024|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 1||0.024|-0.611|
73987070|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.221|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.533|0.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 1||0.092|-0.533|
73987071|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.242|0.388|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 1||0.388|-0.242|
73987072|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.241|0.462|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Week 4||0.462|-0.241|
74034864|NCT01290445|147622199|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.37|1.16||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.16|0.37|
73875365|NCT01276639|147292545|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73987073|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.445|0.261|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Week 4||0.261|-0.445|
73987074|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.301|0.406|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Week 4||0.406|-0.301|
73987075|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.555|0.15|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 4||0.150|-0.555|
73987076|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.411|0.296|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 4||0.296|-0.411|
73987077|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.208|0.496|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 4||0.496|-0.208|
73987078|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.217|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.568|0.135|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Week 4||0.135|-0.568|
73987079|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.363|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.714|-0.012|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Week 4||-0.012|-0.714|
73987080|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.246|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.598|0.106|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Week 4||0.106|-0.598|
73987081|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|95.0|-0.503|0.21|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 4||0.210|-0.503|
73987082|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.178|||TWO_SIDED|95.0|-0.379|0.321|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 4||0.321|-0.379|
73987083|NCT01040403|147519298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.235|0.47|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 4||0.470|-0.235|
74034865|NCT03446651|147622201|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||||||0.56
73875366|NCT01276639|147292545|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73875367|NCT00896298|147292600|SUPERIORITY|||||||0.2572|||||||Mixed Models Analysis|||||||0.2572
73875368|NCT00896298|147292601|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||||||0.71
73987084|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.223|0.25|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Day 1||0.250|-0.223|
73987085|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.37|0.104|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Day 1||0.104|-0.370|
73987086|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.278|0.199|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Day 1||0.199|-0.278|
73987087|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.382|0.088|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 1||0.088|-0.382|
73987088|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.291|0.186|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 1||0.186|-0.291|
73875369|NCT00896298|147292602|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.68
74034866|NCT03446651|147622203|SUPERIORITY|||||||0.039|||||||t-test, 2 sided|||||||0.039
74034867|NCT03446651|147622205|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74034868|NCT03446651|147622206|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74034869|NCT05142332|147622207|SUPERIORITY||Adjusted absolute difference|11.9|||<|0.001|TWO_SIDED|95.0|4.5|19.3|||Regression, Logistic|||||19.3|4.5|<0.001
74034870|NCT05142332|147622208|SUPERIORITY||Adjusted absolute difference|7.9|||<|0.001|TWO_SIDED|95.0|1.7|14.1|||Regression, Logistic|||||14.1|1.7|<0.001
73987089|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.144|0.332|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 1||0.332|-0.144|
74089719|NCT01277718|147732314|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|96.2|||||TWO_SIDED|90.0|85.06|108.77|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||108.77|85.06|
73875370|NCT00896298|147292603|SUPERIORITY|||||||0.0256|||||||Mixed Models Analysis|||||||0.0256
73987090|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.282|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.519|-0.045|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Day 1||-0.045|-0.519|
74034871|NCT04436822|147622276|SUPERIORITY||Intercept from ANCOVA as agreement rate|88.9|||<|0.05|TWO_SIDED|90.0|87.1|90.7|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||90.7|87.1|<0.05
74034872|NCT04436822|147622276|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.5|||<|0.05|TWO_SIDED|90.0|85.4|89.7|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||89.7|85.4|<0.05
74034873|NCT04436822|147622276|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.9|||<|0.05|TWO_SIDED|90.0|85.8|89.9|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||89.9|85.8|<0.05
74089720|NCT01277718|147732314|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|106.0|||||TWO_SIDED|90.0|94.53|119.91|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||119.91|94.53|
74089721|NCT01277718|147732315|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|100.0|||||TWO_SIDED|90.0|85.09|118.03|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||118.03|85.09|
74089722|NCT01277718|147732315|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|85.7|||||TWO_SIDED|90.0|72.51|101.33|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||101.33|72.51|
74089723|NCT01277718|147732315|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|85.9|||||TWO_SIDED|90.0|72.94|101.17|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||101.17|72.94|
74089724|NCT00788593|147732339|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|1.023||||0.228|TWO_SIDED|95.0|-0.656|2.701|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) was based on LS mean from analysis of covariance (ANCOVA) which included participant as random effect, treatment, period and sequence as fixed effects, and placebo baseline CFA value as covariate.||2.701|-0.656|0.228
74089725|NCT00788593|147732340|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74089726|NCT00788593|147732340|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74089727|NCT00788593|147732341|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74089728|NCT00788593|147732341|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74089729|NCT00515034|147732345|NON_INFERIORITY_OR_EQUIVALENCE|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|-13.8|||||TWO_SIDED|95.0|-54.4|26.8|||normal approximation to the binomial||Treatment difference (doripenem minus imipenem/cilastatin) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are provided.||26.8|-54.4|
74089730|NCT00515034|147732346|NON_INFERIORITY_OR_EQUIVALENCE|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|18.7|||||TWO_SIDED|95.0|-13.2|50.6|||normal approximation to binomial||Treatment difference (doripenem minus imipenem) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are presented.||50.6|-13.2|
74089731|NCT01169259|147732407|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.47|TWO_SIDED|95.0|0.88|1.06|||Regression, Cox|||||1.06|0.88|0.47
73987091|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.35|0.124|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Day 1||0.124|-0.350|
74089732|NCT01169259|147732407|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.56|TWO_SIDED|95.0|0.93|1.13|||Regression, Cox|||||1.13|0.93|0.56
74089733|NCT01169259|147732408|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.69|TWO_SIDED|95.0|0.85|1.12|||Regression, Cox|||||1.12|0.85|0.69
74089734|NCT01169259|147732408|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.24|TWO_SIDED|95.0|0.8|1.06|||Regression, Cox|||||1.06|0.80|0.24
74089735|NCT01169259|147732409|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.08|TWO_SIDED|95.0|0.67|1.02|||Regression, Cox|||||1.02|0.67|0.08
74089736|NCT01169259|147732409|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.79|TWO_SIDED|95.0|0.79|1.2|||Regression, Cox|||||1.20|0.79|0.79
74089737|NCT01169259|147732410|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9|TWO_SIDED|95.0|0.79|1.31|||Regression, Cox|||||1.31|0.79|0.90
74089738|NCT01169259|147732410|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.43|TWO_SIDED|95.0|0.7|1.16|||Regression, Cox|||||1.16|0.70|0.43
74089739|NCT01169259|147732411|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.19|TWO_SIDED|95.0|0.72|1.07|||Regression, Cox|||||1.07|0.72|0.19
73987092|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.293|0.18|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Day 1||0.180|-0.293|
73987093|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.069|0.408|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 1||0.408|-0.069|
73987094|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.01|0.461|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 1||0.461|-0.010|
73987095|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.18|0.293|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 1||0.293|-0.180|
73987096|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.067|0.387|||Mixed Models Analysis||Difference calculated as T+O 1.25/ minus Olo 5|Day 29||0.387|-0.067|
73987097|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.034|0.491|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Day 29||0.491|0.034|
73987098|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|95.0|-0.148|0.316|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Day 29||0.316|-0.148|
73987099|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.115|||TWO_SIDED|95.0|-0.124|0.328|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 29||0.328|-0.124|
73987100|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.306|0.154|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 29||0.154|-0.306|
73987101|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.408|0.052|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 29||0.052|-0.408|
74034874|NCT03855137|147622299|SUPERIORITY||Least Squares Mean Difference|-2.41|STANDARD_ERROR_OF_MEAN|0.547||0.0001|TWO_SIDED|95.0|-3.48|-1.33||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Mixed Model Repeated Measures (MMRM)||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.33|-3.48|0.0001
74034875|NCT03855137|147622299|SUPERIORITY||Least Squares Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.545||0.0009|TWO_SIDED|95.0|-2.89|-0.75||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.75|-2.89|0.0009
73987102|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.056|0.4|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Day 29||0.400|-0.056|
73987103|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.171|0.285|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Day 29||0.285|-0.171|
73987104|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.11|0.346|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Day 29||0.346|-0.110|
74089740|NCT01169259|147732411|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.17|TWO_SIDED|95.0|0.94|1.39|||Regression, Cox|||||1.39|0.94|0.17
73987105|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.115|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.345|0.115|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 29||0.115|-0.345|
73987106|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.281|0.173|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 29||0.173|-0.281|
74089741|NCT01169259|147732412|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.67|TWO_SIDED|95.0|0.73|1.62|||Regression, Cox|||||1.62|0.73|0.67
73987107|NCT01040403|147519299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.166|0.289|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 29||0.289|-0.166|
73987108|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.481|0.037|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.037|-0.481|
73987109|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.441|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.7|-0.182|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||-0.182|-0.700|
73987110|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.409|0.111|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.111|-0.409|
73987111|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.219|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.478|0.04|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.040|-0.478|
74089742|NCT01169259|147732412|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.31|TWO_SIDED|95.0|0.83|1.83|||Regression, Cox|||||1.83|0.83|0.31
74089743|NCT01169259|147732413|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.53|TWO_SIDED|95.0|0.86|1.08|||Regression, Cox|||||1.08|0.86|0.53
74089744|NCT01169259|147732413|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21|TWO_SIDED|95.0|0.82|1.04|||Regression, Cox|||||1.04|0.82|0.21
74089745|NCT01169259|147732414|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.73|TWO_SIDED|95.0|0.78|1.19|||Regression, Cox|||||1.19|0.78|0.73
73987112|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.189|0.335|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.335|-0.189|
73987113|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|0.031|0.553|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.553|0.031|
73987114|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.382|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.641|-0.123|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||-0.123|-0.641|
73987115|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.132|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.39|0.127|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.127|-0.390|
73987116|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.585|-0.067|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||-0.067|-0.585|
73987117|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.01|0.511|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.511|-0.010|
73987118|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.202|0.314|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.314|-0.202|
73987119|NCT01040403|147519300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.194|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.453|0.065|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.065|-0.453|
73987120|NCT03036150|147519306|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.0001||95.0|0.51|0.72|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.72|0.51|< 0.0001
73987121|NCT03036150|147519307|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001||95.0|0.45|0.68|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.68|0.45|< 0.0001
73987122|NCT03036150|147519308|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0089||95.0|0.55|0.92|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.92|0.55|0.0089
73987123|NCT03036150|147519309|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0035||95.0|0.53|0.88|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.88|0.53|0.0035
73987124|NCT02845375|147519333|SUPERIORITY|||||||0.299|||||||ANCOVA|||||||0.299
73987125|NCT01177137|147519338|SUPERIORITY||Slope|-2.35|STANDARD_ERROR_OF_MEAN|3.27||0.47|TWO_SIDED|95.0|-8.77|4.07||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||4.07|-8.77|0.47
73987126|NCT01177137|147519338|SUPERIORITY||Slope|-2.8|STANDARD_ERROR_OF_MEAN|2.78||0.31|TWO_SIDED|95.0|-8.27|2.65||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.65|-8.27|0.31
73987127|NCT01177137|147519339|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|2.63||0.96|TWO_SIDED|95.0|-5.3|5.02||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.02|-5.30|0.96
73987128|NCT01177137|147519339|SUPERIORITY||Slope|2.74|STANDARD_ERROR_OF_MEAN|2.53||0.28|TWO_SIDED|95.0|-2.21|7.7||The a priori threshold for statistical significance was \<0.025 to adjust for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.70|-2.21|0.28
73987129|NCT01177137|147519340|SUPERIORITY||Slope|0.61|STANDARD_ERROR_OF_MEAN|0.59||0.3|TWO_SIDED|95.0|-0.55|1.77||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.77|-0.55|0.30
74089746|NCT01169259|147732414|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.003|TWO_SIDED|95.0|0.59|0.9|||Regression, Cox|||||0.90|0.59|0.003
74089747|NCT01169259|147732415|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.68|TWO_SIDED|95.0|0.76|1.2|||Regression, Cox|||||1.20|0.76|0.68
74089748|NCT01169259|147732415|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.72|TWO_SIDED|95.0|0.83|1.31|||Regression, Cox|||||1.31|0.83|0.72
74089749|NCT01169259|147732416|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.38|TWO_SIDED|95.0|0.88|1.4|||Regression, Cox|||||1.40|0.88|0.38
74089750|NCT01169259|147732416|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.73|TWO_SIDED|95.0|0.76|1.21|||Regression, Cox|||||1.21|0.76|0.73
74089751|NCT01169259|147732417|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.87|TWO_SIDED|95.0|0.87|1.12|||Regression, Cox|||||1.12|0.87|0.87
74089752|NCT01169259|147732417|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.79|TWO_SIDED|95.0|0.9|1.15|||Regression, Cox|||||1.15|0.90|0.79
74089753|NCT01169259|147732418|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.33|TWO_SIDED|95.0|0.83|1.06|||Regression, Cox|||||1.06|0.83|0.33
74089754|NCT01169259|147732418|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.056|TWO_SIDED|95.0|1.0|1.28|||Regression, Cox|||||1.28|1.00|0.056
74089755|NCT01169259|147732419|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.38|TWO_SIDED|95.0|0.79|1.09|||Regression, Cox|||||1.09|0.79|0.38
74089756|NCT01169259|147732419|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.18|TWO_SIDED|95.0|0.76|1.05|||Regression, Cox|||||1.05|0.76|0.18
74034876|NCT03855137|147622300|SUPERIORITY||Least Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|0.547||0.0001|TWO_SIDED|95.0|-3.31|-1.16||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.16|-3.31|0.0001
74034877|NCT03855137|147622300|SUPERIORITY||Least Squares Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.544||0.0024|TWO_SIDED|95.0|-2.72|-0.59|||MMRM|Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.59|-2.72|0.0024
74034878|NCT03855137|147622301|SUPERIORITY||Least Squares Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.541||0.0001|TWO_SIDED|95.0|-3.38|-1.26||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.26|-3.38|0.0001
74034879|NCT03855137|147622301|SUPERIORITY||Least Squares Mean Difference|-1.87|STANDARD_ERROR_OF_MEAN|0.538||0.0009|TWO_SIDED|95.0|-2.93|-0.81||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.81|-2.93|0.0009
74034880|NCT03855137|147622302|SUPERIORITY||Least Squares Mean Difference|-2.14|STANDARD_ERROR_OF_MEAN|0.539||0.0002|TWO_SIDED|95.0|-3.2|-1.09||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.09|-3.20|0.0002
73875371|NCT00466440|147292604|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.2||||1|TWO_SIDED|90.0|-12.52|12.95|||Chi-squared||The objective response rates and the 90% confidence intervals were estimated for the qualified participants using unadjusted normal approximation for binomial proportions (z approximation).|||12.95|-12.52|1.0000
73987130|NCT01177137|147519340|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.58||0.29|TWO_SIDED|95.0|-1.75|0.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.52|-1.75|0.29
73987131|NCT01177137|147519342|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|1.37||0.77|TWO_SIDED|95.0|-3.08|2.29||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.29|-3.08|0.77
73987132|NCT01177137|147519342|SUPERIORITY||Slope|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.65|TWO_SIDED|95.0|-3.16|1.96||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.96|-3.16|0.65
73875372|NCT00466440|147292605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6||||0.3606|TWO_SIDED|90.0|-28.21|4.95|||Chi-squared|||||4.95|-28.21|0.3606
73987133|NCT01177137|147519343|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.52||0.5|TWO_SIDED|95.0|-1.38|0.67||The a priori threshold for statistical significance was set at \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.67|-1.38|0.50
73987134|NCT01177137|147519343|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.52||0.82|TWO_SIDED|95.0|-1.14|0.9||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.90|-1.14|0.82
74034881|NCT03855137|147622302|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.536||0.0024|TWO_SIDED|95.0|-2.78|-0.67||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.67|-2.78|0.0024
74034882|NCT03855137|147622303|SUPERIORITY||Least Squares Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.51||0.0001|TWO_SIDED|95.0|-3.63|-1.63||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.63|-3.63|0.0001
74039565|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.09||||0.8331|TWO_SIDED|95.0|0.49|2.4|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.40|0.49|0.8331
73875373|NCT00466440|147292606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26||||0.072|TWO_SIDED|90.0|-0.02|0.55|||t-test, 1 sided|||||0.55|-0.02|0.0720
73875374|NCT00466440|147292607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15||||0.1697|TWO_SIDED|90.0|-0.07|0.37|||t-test, 1 sided|||||0.37|-0.07|0.1697
73987135|NCT01177137|147519344|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.51||0.46|TWO_SIDED|95.0|-1.37|0.62||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation.|||0.62|-1.37|0.46
73987136|NCT01177137|147519344|SUPERIORITY|The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.51||0.48|TWO_SIDED|95.0|-1.35|0.64|||repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.64|-1.35|0.48
73987137|NCT01177137|147519345|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.75|TWO_SIDED|95.0|-0.74|0.53||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.53|-0.74|0.75
73987138|NCT01177137|147519345|SUPERIORITY||Slope|-0.87|STANDARD_ERROR_OF_MEAN|0.35||0.015|TWO_SIDED|95.0|-1.56|-0.17||The a priori threshold for statistical significance was \< 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-0.17|-1.56|0.015
73987139|NCT01177137|147519346|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.39||0.85|TWO_SIDED|95.0|-0.83|0.69||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.69|-0.83|0.85
73987140|NCT01177137|147519346|SUPERIORITY||Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.55|TWO_SIDED|95.0|-0.86|0.46||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.46|-0.86|0.55
73987141|NCT01177137|147519347|SUPERIORITY||Slope|-3.19|STANDARD_ERROR_OF_MEAN|3.1||0.3|TWO_SIDED|95.0|-9.27|2.88||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.88|-9.27|0.30
73987142|NCT01177137|147519347|SUPERIORITY||Slope|-0.91|STANDARD_ERROR_OF_MEAN|2.98||0.76|TWO_SIDED|95.0|-6.75|4.93||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||4.93|-6.75|0.76
73987143|NCT01177137|147519348|SUPERIORITY||Slope|3.12|STANDARD_ERROR_OF_MEAN|3.34||0.35|TWO_SIDED|95.0|-3.44|9.68||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||9.68|-3.44|0.35
73987144|NCT01177137|147519348|SUPERIORITY||Slope|3.29|STANDARD_ERROR_OF_MEAN|3.19||0.3|TWO_SIDED|95.0|-2.96|9.54||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||9.54|-2.96|0.30
74034883|NCT03855137|147622303|SUPERIORITY||Least Squares Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.508||0.0009|TWO_SIDED|95.0|-3.13|-1.13||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.13|-3.13|0.0009
73875375|NCT00466440|147292608|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.524|TWO_SIDED|95.0|0.5|1.4|||Log Rank|||||1.4|0.5|0.5240
74034884|NCT03855137|147622304|SUPERIORITY||Least Squares Mean Difference|-2.52|STANDARD_ERROR_OF_MEAN|0.507||0.0002|TWO_SIDED|95.0|-3.52|-1.53||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.53|-3.52|0.0002
74034885|NCT03855137|147622304|SUPERIORITY||Least Squares Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.505||0.0024|TWO_SIDED|95.0|-3.09|-1.1|||MMRM|||||-1.10|-3.09|0.0024
74089757|NCT01169259|147732420|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.024|TWO_SIDED|95.0|0.59|0.96|||Regression, Cox|||||0.96|0.59|0.024
74089758|NCT01169259|147732420|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.58|TWO_SIDED|95.0|0.73|1.19|||Regression, Cox|||||1.19|0.73|0.58
74089759|NCT01169259|147732421|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.62|TWO_SIDED|95.0|0.84|1.11|||Regression, Cox|||||1.11|0.84|0.62
73875376|NCT00466440|147292609|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.4407|TWO_SIDED|95.0|0.3|1.6|||Log Rank|||||1.6|0.3|0.4407
73875377|NCT00466440|147292610|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.3449|TWO_SIDED|95.0|0.4|1.4|||Log Rank|||||1.4|0.4|0.3449
73875378|NCT00796666|147292628|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8616||||0.5416|TWO_SIDED|95.0|0.602|1.233|||Log Rank|||||1.233|0.602|0.5416
73875379|NCT00796666|147292629|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||P-value was based on the analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO Functional Class (FC) as fixed effects and baseline 6 Minute Walk Distance (6MWD) as a covariate.|ANCOVA|||Baseline to Week 12||||0.0049
73875380|NCT00796666|147292630|SUPERIORITY_OR_OTHER|||||||0.8223|TWO_SIDED|||||Missing values at Week 12 and Week 24 were imputed with the last non-missing WHO FC based on the last observation carried forward (LOCF) method.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test used modified ridit scores and the p-value corresponding to the ANCOVA (row mean scores) statistic was reported.||Baseline to Week 12||||0.8223
73875381|NCT00796666|147292631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-3.13|1.2|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12||1.20|-3.13|
73875382|NCT00796666|147292631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|0.31|4.36|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12||4.36|0.31|
73875383|NCT00796666|147292631|SUPERIORITY_OR_OTHER|||||||0.0094|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0094
73875384|NCT00796666|147292632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|-3.92|1.2|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12||1.20|-3.92|
73875385|NCT00796666|147292632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-0.38|4.35|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12||4.35|-0.38|
73875386|NCT00796666|147292632|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0244
73987145|NCT01177137|147519349|SUPERIORITY||Slope|1.41|STANDARD_ERROR_OF_MEAN|3.37||0.68|TWO_SIDED|95.0|-5.2|8.02||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||8.02|-5.20|0.68
73987146|NCT01177137|147519349|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|3.26||0.77|TWO_SIDED|95.0|-5.44|7.33||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.33|-5.44|0.77
73987147|NCT01177137|147519350|SUPERIORITY||Slope|-3.53|STANDARD_ERROR_OF_MEAN|4.47||0.43|TWO_SIDED|95.0|-12.3|5.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.23|-12.30|0.43
73987148|NCT01177137|147519350|SUPERIORITY||Slope|-13.7|STANDARD_ERROR_OF_MEAN|4.24||0.001|TWO_SIDED|95.0|-22.02|-5.38||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-5.38|-22.02|0.001
74034886|NCT03855137|147622305|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0003|TWO_SIDED|95.0|1.45|3.14||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||3.14|1.45|0.0003
73875387|NCT00796666|147292633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-3.78|2.04|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12||2.04|-3.78|
73875388|NCT00796666|147292633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|95.0|-0.41|4.9|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12||4.90|-0.41|
73875389|NCT00796666|147292633|SUPERIORITY_OR_OTHER|||||||0.0624|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0624
73875390|NCT00796666|147292634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-2.57|2.06|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FCvas fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12||2.06|-2.57|
73987149|NCT01177137|147519351|SUPERIORITY||Slope|3.71|STANDARD_ERROR_OF_MEAN|3.91||0.34|TWO_SIDED|95.0|-3.96|11.38||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||11.38|-3.96|0.34
73987150|NCT01177137|147519351|SUPERIORITY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|3.82||0.95|TWO_SIDED|95.0|-7.72|7.26||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.26|-7.72|0.95
73987151|NCT01177137|147519352|SUPERIORITY||Slope|-1.85|STANDARD_ERROR_OF_MEAN|3.69||0.62|TWO_SIDED|95.0|-9.07|5.38||The a priori threshold for statistical significance was \< 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.38|-9.07|0.62
73987152|NCT01177137|147519352|SUPERIORITY||Slope|-4.46|STANDARD_ERROR_OF_MEAN|3.58||0.21|TWO_SIDED|95.0|-11.48|2.55||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.55|-11.48|0.21
73987153|NCT01177137|147519353|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|3.39||0.97|TWO_SIDED|95.0|-6.78|6.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||6.52|-6.78|0.97
73987154|NCT01177137|147519353|SUPERIORITY||Slope|-3.02|STANDARD_ERROR_OF_MEAN|3.27||0.36|TWO_SIDED|95.0|-9.43|3.4||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||3.40|-9.43|0.36
73987155|NCT01177137|147519354|SUPERIORITY||Slope|1.24|STANDARD_ERROR_OF_MEAN|3.01||0.68|TWO_SIDED|95.0|-4.67|7.14||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.14|-4.67|0.68
73987156|NCT01177137|147519354|SUPERIORITY||Slope|-3.52|STANDARD_ERROR_OF_MEAN|2.93||0.23|TWO_SIDED|95.0|-9.26|2.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.23|-9.26|0.23
73987157|NCT01177137|147519355|SUPERIORITY||Slope|-0.82|STANDARD_ERROR_OF_MEAN|1.27||0.52|TWO_SIDED|95.0|-3.3|1.66||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.66|-3.30|0.52
73987158|NCT01177137|147519355|SUPERIORITY||Slope|-2.81|STANDARD_ERROR_OF_MEAN|1.22||0.022|TWO_SIDED|95.0|-5.21|-0.41||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-0.41|-5.21|0.022
73987159|NCT01177137|147519356|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.96||0.72|TWO_SIDED|95.0|-1.54|2.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.23|-1.54|0.72
73987160|NCT01177137|147519356|SUPERIORITY||Slope|-1.04|STANDARD_ERROR_OF_MEAN|0.91||0.26|TWO_SIDED|95.0|-2.83|0.75||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.75|-2.83|0.26
73987161|NCT01177137|147519357|SUPERIORITY||Slope|0.61|STANDARD_ERROR_OF_MEAN|0.59||0.3|TWO_SIDED|95.0|0.55|1.78||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.78|0.55|0.30
74039566|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.51||||0.2682|TWO_SIDED|95.0|0.73|3.12|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.12|0.73|0.2682
73987162|NCT01177137|147519357|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.58||0.29|TWO_SIDED|95.0|-1.75|0.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.52|-1.75|0.29
73987163|NCT02959177|147519358|SUPERIORITY||LSMean Difference|-3.01|||<|0.001|TWO_SIDED|95.0|-3.8|-2.22|||Mixed Models Analysis|||||-2.22|-3.80|<0.001
73987164|NCT02959177|147519358|SUPERIORITY||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED|95.0|-3.53|-1.94|||Mixed Models Analysis|||||-1.94|-3.53|<0.001
73987165|NCT02959177|147519359|SUPERIORITY||Odds Ratio (OR)|3.89|||||TWO_SIDED|95.0|2.71|5.57||||||||5.57|2.71|
73987166|NCT02959177|147519359|SUPERIORITY||Odds Ratio (OR)|3.664|||||TWO_SIDED|95.0|2.54|5.23||||||||5.23|2.54|
73987167|NCT02959177|147519360|SUPERIORITY||Odds Ratio (OR)|3.24|||||TWO_SIDED|95.0|2.14|4.89||||||||4.89|2.14|
73987168|NCT02959177|147519360|SUPERIORITY||Odds Ratio (OR)|3.16|||||TWO_SIDED|95.0|2.08|4.8||||||||4.80|2.08|
74034887|NCT03855137|147622305|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0009|TWO_SIDED|95.0|1.38|3.0||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||3.00|1.38|0.0009
74034888|NCT03855137|147622306|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0006|TWO_SIDED|95.0|1.38|2.98||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||2.98|1.38|0.0006
73875391|NCT00796666|147292634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|0.48|4.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12||4.82|0.48|
73987169|NCT02959177|147519361|SUPERIORITY||Odds Ratio (OR)|3.47|||||TWO_SIDED|95.0|2.03|5.93||||||||5.93|2.03|
73987170|NCT02959177|147519361|SUPERIORITY||Odds Ratio (OR)|3.13|||||TWO_SIDED|95.0|1.79|5.44||||||||5.44|1.79|
73987171|NCT02959177|147519362|SUPERIORITY||LSMean difference|7.0|||<|0.001|TWO_SIDED|95.0|4.54|9.46|||Mixed Models Analysis|||||9.46|4.54|<0.001
73987172|NCT02959177|147519362|SUPERIORITY||Mean Difference (Final Values)|5.79|||<|0.01|TWO_SIDED|95.0|3.33|8.24|||Mixed Models Analysis|||||8.24|3.33|<0.01
73987173|NCT02959177|147519363|SUPERIORITY||LSMean difference|-2.9|||<|0.001|TWO_SIDED|95.0|-3.61|-2.19|||Mixed Models Analysis|||||-2.19|-3.61|<0.001
73987174|NCT02959177|147519363|SUPERIORITY||LSMean difference|-2.7|||<|0.001|TWO_SIDED|95.0|-3.41|-1.99|||Mixed Models Analysis|||||-1.99|-3.41|<0.001
73987175|NCT02959177|147519365|SUPERIORITY||LSMean Difference|-11.82|||<|0.001|TWO_SIDED|95.0|-16.14|-7.51|||Mixed Models Analysis|||||-7.51|-16.14|<0.001
73987176|NCT02959177|147519365|SUPERIORITY||LSMean difference|-13.73|||<|0.001|TWO_SIDED|95.0|-18.05|-9.4|||Mixed Models Analysis|||||-9.40|-18.05|<0.001
74034889|NCT03855137|147622306|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.29|2.79||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||2.79|1.29|0.0009
73987177|NCT02959177|147519366|SUPERIORITY||LSMean Difference|-4.9|||<|0.001|TWO_SIDED|95.0|-8.06|-1.73|||Mixed Models Analysis|||||-1.73|-8.06|<0.001
73987178|NCT02959177|147519366|SUPERIORITY||LSMean Difference|-2.97|||<|0.001|TWO_SIDED|95.0|-6.08|0.14|||Mixed Models Analysis|||||0.14|-6.08|<.001
73987179|NCT02381652|147519388|OTHER|Statistical test to see if there is a difference||||||0.3108|||||||Fisher Exact|||||||0.3108
74039567|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0001|TWO_SIDED|95.0|1.31|2.29|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.29|1.31|0.0001
73987180|NCT01340300|147519389|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||<0.0001
73987181|NCT01340300|147519389|SUPERIORITY|||||||0.003||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||0.003
73987182|NCT01340300|147519389|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||0.01
73987183|NCT01340300|147519389|SUPERIORITY|||||||0.03||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Insulin in combined arm is greater than the exercise-only or metformin-only arm.||||0.03
73987184|NCT01340300|147519390|SUPERIORITY|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of leptin in treatment arm is greater than the control arm.||||0.0002
73987185|NCT01340300|147519390|SUPERIORITY|||||||0.002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP\_1 in treatment arm is greater than the control arm.||||0.002
73987186|NCT01340300|147519390|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP\_1 in treatment arm is greater than the control arm.||||0.02
73987187|NCT01340300|147519390|SUPERIORITY|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.||||0.0002
73987188|NCT01340300|147519390|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.||||0.02
73987189|NCT01340300|147519391|SUPERIORITY|||||||0.0004||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.||||0.0004
73987190|NCT01340300|147519391|SUPERIORITY|||||||0.007||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.||||0.007
73987191|NCT01340300|147519392|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||<0.0001
74034890|NCT03855137|147622307|SUPERIORITY||Least Squares Mean Difference|7.43|STANDARD_ERROR_OF_MEAN|1.864||0.0006|TWO_SIDED|95.0|3.77|11.09||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||11.09|3.77|0.0006
74034891|NCT03855137|147622307|SUPERIORITY||Least Squares Mean Difference|5.78|STANDARD_ERROR_OF_MEAN|1.848||0.0024|TWO_SIDED|95.0|2.15|9.41||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||9.41|2.15|0.0024
74039568|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.97|||<|0.0001|TWO_SIDED|95.0|1.49|2.61|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.61|1.49|<.0001
73987192|NCT01340300|147519392|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||<0.0001
74089760|NCT01169259|147732421|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.72|TWO_SIDED|95.0|0.84|1.12|||Regression, Cox|||||1.12|0.84|0.72
74089761|NCT01169259|147732422|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.78|TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|||||1.19|0.79|0.78
74089762|NCT01169259|147732422|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.016|TWO_SIDED|95.0|0.63|0.95|||Regression, Cox|||||0.95|0.63|0.016
74089763|NCT01169259|147732423|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.058|TWO_SIDED|95.0|0.55|1.01|||Regression, Cox|||||1.01|0.55|0.058
74089764|NCT01169259|147732423|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.94|TWO_SIDED|95.0|0.73|1.33|||Regression, Cox|||||1.33|0.73|0.94
74089765|NCT01169259|147732424|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.61|TWO_SIDED|95.0|0.83|1.12|||Regression, Cox|||||1.12|0.83|0.61
74089766|NCT01169259|147732424|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.016|TWO_SIDED|95.0|0.71|0.97|||Regression, Cox|||||0.97|0.71|0.016
73987193|NCT01340300|147519392|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||0.01
73987194|NCT01340300|147519393|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||<0.0001
73987195|NCT01340300|147519393|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||<0.0001
73987196|NCT01340300|147519393|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||0.02
73987197|NCT01340300|147519394|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Waist to Hip Ratio in treatment arm is greater than the control arm.||||0.01
73987198|NCT01954771|147519405|SUPERIORITY_OR_OTHER||Correlation coefficient|0.726|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||<0.001
73987199|NCT01954771|147519405|SUPERIORITY_OR_OTHER||Correlation coefficient|0.522||||0.004|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||0.004
73987200|NCT01954771|147519405|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.784|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||<0.001
73987201|NCT01954771|147519405|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.533||||0.011|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||0.011
73987202|NCT01954771|147519405|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.479||||0.009|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||0.009
74039569|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0071|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.10|0.0071
73987203|NCT01954771|147519405|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.801|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||<0.001
73987204|NCT00999141|147519410|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||two-sided paired t-test|alpha = 5%||||||<0.0001
73987205|NCT00999141|147519413|SUPERIORITY_OR_OTHER||Difference in Proportions|0.04||||0.257||95.0|-0.039|0.125|||McNemar|alpha = 5%|Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||0.125|-0.039|0.257
73987206|NCT00999141|147519414|SUPERIORITY_OR_OTHER||Difference in proportions|-0.373|||<|0.001||95.0|-0.524|-0.193|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.193|-0.524|<0.001
73987207|NCT00999141|147519415|SUPERIORITY_OR_OTHER||Difference in proportions|-0.387|||<|0.001||95.0|-0.538|-0.205|||McNemar||Difference in Proportions = SoC - FS VH S/D 4 s-apr|||-0.205|-0.538|<0.001
73987208|NCT00999141|147519416|SUPERIORITY_OR_OTHER||Difference in proportions|-0.356||||0.001||95.0|-0.521|-0.161|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.161|-0.521|0.001
73987209|NCT00999141|147519417|SUPERIORITY_OR_OTHER||Difference in proportions|-0.189||||0.027||95.0|-0.342|-0.023|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.023|-0.342|0.027
73987210|NCT00999141|147519420|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.413||||||95.0|-0.577|-0.213|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.213|-0.577|
73987211|NCT00999141|147519421|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.227||||||95.0|-0.413|-0.02|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.020|-0.413|
73987212|NCT00999141|147519422|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.347||||||95.0|-0.518|-0.145|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.145|-0.518|
73987213|NCT00999141|147519423|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.365||||||95.0|-0.528|-0.171|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.171|-0.528|
73987214|NCT03569475|147519469|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.41||0.2215|TWO_SIDED|95.0|-4.49|1.04|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||1.04|-4.49|0.2215
74034892|NCT03855137|147622308|SUPERIORITY||Least Squares Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|0.968||0.0003|TWO_SIDED|95.0|-6.75|-2.95||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-2.95|-6.75|0.0003
73987215|NCT03569475|147519469|SUPERIORITY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.41||0.1964|TWO_SIDED|95.0|-4.59|0.95|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||0.95|-4.59|0.1964
73987216|NCT03569475|147519470|SUPERIORITY||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.6789|TWO_SIDED|95.0|-0.32|0.21|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||0.21|-0.32|0.6789
73987217|NCT03569475|147519470|SUPERIORITY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1126|TWO_SIDED|95.0|-0.48|0.05|||Mixed Model for Repeated Measures|||||0.05|-0.48|0.1126
73987218|NCT03638258|147519471|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward (LOCF) where linear interpolation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||||||<0.001
73987219|NCT03638258|147519471|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpolation was not computationally possible.||||||0.004|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||||||0.004
73987220|NCT03638258|147519472|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.015|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.015
73987221|NCT03638258|147519472|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.174|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from placebo at Week 4||||0.174
73987222|NCT03638258|147519472|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||<0.001
73987223|NCT03638258|147519472|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||0.001
73987224|NCT03638258|147519472|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||<0.001
73987225|NCT03638258|147519472|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.008|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.008
73987226|NCT03638258|147519473|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 4||||<0.001
73987227|NCT03638258|147519473|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 4||||<0.001
73987228|NCT03638258|147519473|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 6||||<0.001
73987229|NCT03638258|147519473|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 6||||<0.001
73987230|NCT03638258|147519473|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.x|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 8||||<0.001
73987231|NCT03638258|147519473|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 8||||<0.001
73987232|NCT03638258|147519473|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 12||||<0.001
73987233|NCT03638258|147519473|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 12||||<0.001
73987234|NCT03638258|147519474|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream on Week 4||||<0.001
73987235|NCT03638258|147519474|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 4||||<0.001
73987236|NCT03638258|147519474|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 6||||<0.001
73987237|NCT03638258|147519474|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 6||||<0.001
73987238|NCT03638258|147519474|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle at Week 8||||<0.001
73987239|NCT03638258|147519474|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 8||||<0.001
73987240|NCT03638258|147519474|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle at Week 12||||<0.001
73987241|NCT03638258|147519474|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 12||||<0.001
73987242|NCT03638258|147519475|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.116|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.116
73987243|NCT03638258|147519475|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.423|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.423
73987244|NCT03638258|147519475|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 6||||0.002
73987245|NCT03638258|147519475|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.038|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 6||||0.038
73987246|NCT03638258|147519475|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||<0.001
73987247|NCT03638258|147519475|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.005|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||0.005
73987248|NCT03638258|147519475|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.002
73987249|NCT03638258|147519475|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.013|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.013
73987250|NCT03638258|147519476|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.086|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference form vehicle cream at Week 4||||0.086
73987251|NCT03638258|147519476|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.123|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 4||||0.123
73987252|NCT03638258|147519476|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.017|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 6||||0.017
73987253|NCT03638258|147519476|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.415|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 6||||0.415
73987254|NCT03638258|147519476|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.007|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 8||||0.007
73987255|NCT03638258|147519476|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.175|||||||Regression, Linear|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 8||||0.175
73987256|NCT03638258|147519476|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle at Week 12||||0.001
74089767|NCT01169259|147732425|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.61|TWO_SIDED|95.0|0.83|1.39|||Regression, Cox|||||1.39|0.83|0.61
74089768|NCT01169259|147732425|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.74|TWO_SIDED|95.0|0.74|1.24|||Regression, Cox|||||1.24|0.74|0.74
74089769|NCT01169259|147732426|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.37|TWO_SIDED|95.0|0.42|1.38|||Regression, Cox|||||1.38|0.42|0.37
73956511|NCT00708097|147449047|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.87|||<|0.0001|TWO_SIDED|95.0|-34.84|-20.89||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.89|-34.84|<0.0001
73987257|NCT03638258|147519476|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.619|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 12||||0.619
73956512|NCT00708097|147449048|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.45||||0.5451|TWO_SIDED|95.0|-6.15|3.26||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||3.26|-6.15|0.5451
73956513|NCT00708097|147449048|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.5||||0.1433|TWO_SIDED|95.0|-1.2|8.19||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.19|-1.20|0.1433
73956514|NCT00708097|147449048|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.47||||0.002|TWO_SIDED|95.0|2.78|12.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||12.16|2.78|0.0020
73956515|NCT00708097|147449048|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.52|||<|0.0001|TWO_SIDED|95.0|18.79|28.25||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||28.25|18.79|<0.0001
73956516|NCT00708097|147449048|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.94||||0.0373|TWO_SIDED|95.0|0.29|9.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.59|0.29|0.0373
73956517|NCT00708097|147449048|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.92||||0.0002|TWO_SIDED|95.0|4.24|13.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||13.59|4.24|0.0002
73956518|NCT00708097|147449048|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|24.97|||<|0.0001|TWO_SIDED|95.0|20.27|29.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||29.66|20.27|<0.0001
73956519|NCT00708097|147449048|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.98||||0.0925|TWO_SIDED|95.0|-0.66|8.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.61|-0.66|0.0925
73956520|NCT00708097|147449048|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|20.03|||<|0.0001|TWO_SIDED|95.0|15.35|24.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||24.70|15.35|<0.0001
73987258|NCT03638258|147519477|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||<0.001
74039570|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1187|TWO_SIDED|95.0|0.95|1.57|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.57|0.95|0.1187
73875392|NCT00796666|147292634|SUPERIORITY_OR_OTHER|||||||0.0324|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0324
73875393|NCT00796666|147292635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.28|||TWO_SIDED|95.0|-2.1|2.97|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12||2.97|-2.10|
73875394|NCT00796666|147292635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|1.74|6.45|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12||6.45|1.74|
73875395|NCT00796666|147292635|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0136
73875396|NCT00796666|147292636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-2.33|3.23|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12||3.23|-2.33|
73987259|NCT03638258|147519477|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.002
73987260|NCT03638258|147519477|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||<0.001
73987261|NCT03638258|147519477|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||<0.001
73987262|NCT03638258|147519477|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||<0.001
73987263|NCT03638258|147519477|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||<0.001
73987264|NCT03638258|147519477|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
74034893|NCT03855137|147622308|SUPERIORITY||Least Squares Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|0.963||0.0009|TWO_SIDED|95.0|-5.27|-1.49||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.49|-5.27|0.0009
73987265|NCT03638258|147519477|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
74034894|NCT03855137|147622309|SUPERIORITY||Least Squares Mean Difference|-4.19|STANDARD_ERROR_OF_MEAN|0.897||0.0003|TWO_SIDED|95.0|-5.95|-2.43||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-2.43|-5.95|0.0003
73875397|NCT00796666|147292636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.73|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|0.14|5.32|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12||5.32|0.14|
73875398|NCT00796666|147292636|SUPERIORITY_OR_OTHER|||||||0.1582|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.1582
73875399|NCT00796666|147292637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|-3.09|3.18|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12||3.18|-3.09|
73875400|NCT00796666|147292637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-0.62|5.16|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12||5.16|-0.62|
73987266|NCT03638258|147519478|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.002
73987267|NCT03638258|147519478|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.203|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.203
73987268|NCT03638258|147519478|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.034|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||0.034
73987269|NCT03638258|147519478|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.012|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||0.012
73987270|NCT03638258|147519478|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.01|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||0.010
73987271|NCT03638258|147519478|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.075|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||0.075
73987272|NCT03638258|147519478|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
73987273|NCT03638258|147519478|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
73987274|NCT03638258|147519479|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.527|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.527
74034895|NCT03855137|147622309|SUPERIORITY||Least Squares Mean Difference|-2.71|STANDARD_ERROR_OF_MEAN|0.893||0.0025|TWO_SIDED|95.0|-4.47|-0.96||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.96|-4.47|0.0025
74034896|NCT03855137|147622310|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.697||0.0006|TWO_SIDED|95.0|-4.67|-1.93|||MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.93|-4.67|0.0006
74034897|NCT03855137|147622310|SUPERIORITY||Least Squares Mean Difference|-2.66|STANDARD_ERROR_OF_MEAN|0.69||0.0024|TWO_SIDED|95.0|-4.02|-1.3|||MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.30|-4.02|0.0024
74034898|NCT02065622|147622324|SUPERIORITY||Adjusted risk difference|2.5||||0.269|TWO_SIDED|95.0|-2.0|7.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.0|-2.0|0.269
73875401|NCT00796666|147292637|SUPERIORITY_OR_OTHER|||||||0.2161|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2161
73956521|NCT00708097|147449048|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.05|||<|0.0001|TWO_SIDED|95.0|11.36|20.74||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||20.74|11.36|<0.0001
73875402|NCT00796666|147292638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|-1.61|4.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12||4.50|-1.61|
73956522|NCT00708097|147449049|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.01||||0.9697|TWO_SIDED|95.0|-106.34|102.32||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||102.32|-106.34|0.9697
73956523|NCT00708097|147449049|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|106.9||||0.044|TWO_SIDED|95.0|2.92|210.87||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||210.87|2.92|0.0440
73987275|NCT03638258|147519479|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.444|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.444
73987276|NCT03638258|147519479|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.006|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.006
73956524|NCT00708097|147449049|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|160.92||||0.0026|TWO_SIDED|95.0|56.96|264.88||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||264.88|56.96|0.0026
73987277|NCT03638258|147519479|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.013|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.013
73956525|NCT00708097|147449049|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|222.47|||<|0.0001|TWO_SIDED|95.0|117.58|327.36||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||327.36|117.58|<0.0001
73956526|NCT00708097|147449049|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|108.91||||0.0382|TWO_SIDED|95.0|5.98|211.83||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||211.83|5.98|0.0382
73956527|NCT00708097|147449049|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|162.93||||0.0021|TWO_SIDED|95.0|59.68|266.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||266.18|59.68|0.0021
73956528|NCT00708097|147449049|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|224.48|||<|0.0001|TWO_SIDED|95.0|120.51|328.46||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||328.46|120.51|<0.0001
73956529|NCT00708097|147449049|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|54.03||||0.3003|TWO_SIDED|95.0|-48.56|156.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||156.61|-48.56|0.3003
73956530|NCT00708097|147449049|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|61.55||||0.2432|TWO_SIDED|95.0|-42.14|165.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||165.24|-42.14|0.2432
73956531|NCT00708097|147449049|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|115.58||||0.0289|TWO_SIDED|95.0|12.02|219.13||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||219.13|12.02|0.0289
73956532|NCT00708097|147449050|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.9||||0.9293|TWO_SIDED|95.0|-322.47|294.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||294.66|-322.47|0.9293
73956533|NCT00708097|147449050|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|575.71||||0.0003|TWO_SIDED|95.0|268.24|883.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||883.17|268.24|0.0003
73956534|NCT00708097|147449050|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|637.67|||<|0.0001|TWO_SIDED|95.0|330.3|945.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||945.03|330.30|<0.0001
74034899|NCT02065622|147622324|SUPERIORITY|||||||0.447|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.447
74039571|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.39||||0.011|TWO_SIDED|95.0|1.08|1.79|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.79|1.08|0.0110
73987278|NCT03638258|147519479|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.002
73987279|NCT03638258|147519479|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.064|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.064
73987280|NCT03638258|147519479|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.002
73987281|NCT03638258|147519479|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.009|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.009
73987282|NCT03638258|147519480|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.188|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.188
73987283|NCT03638258|147519480|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.577|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.577
73987284|NCT03638258|147519480|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.008|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.008
73987285|NCT03638258|147519480|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.664|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.664
73875403|NCT00796666|147292638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|0.82|6.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12||6.50|0.82|
73987286|NCT03638258|147519480|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.015|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.015
73987287|NCT03638258|147519480|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.666|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.666
73987288|NCT03638258|147519480|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.009|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.009
73987289|NCT03638258|147519480|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.163|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.163
73987290|NCT03638258|147519481|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||||||0.002|||||||ANOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream on Week 4||||0.002
73987291|NCT03638258|147519481|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 4||||0.002
73987292|NCT03638258|147519481|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 6||||<0.001
73987293|NCT03638258|147519481|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from placebo at Week 6||||<0.001
73987294|NCT03638258|147519481|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from placebo at Week 8||||<0.001
73987295|NCT03638258|147519481|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 8||||<0.001
74089770|NCT01169259|147732426|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.37|TWO_SIDED|95.0|0.72|2.39|||Regression, Cox|||||2.39|0.72|0.37
74089771|NCT01169259|147732427|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.15|TWO_SIDED|95.0|0.84|3.06|||Regression, Cox|||||3.06|0.84|0.15
74089772|NCT01169259|147732427|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.04|TWO_SIDED|95.0|0.26|0.97|||Regression, Cox|||||0.97|0.26|0.04
73875404|NCT00796666|147292638|SUPERIORITY_OR_OTHER|||||||0.2087|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2087
73987296|NCT03638258|147519481|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 12||||<0.001
73987297|NCT03638258|147519481|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 12||||<0.001
73987298|NCT03638258|147519482|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.184|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score.||Difference from vehicle cream at Week 4||||0.184
73987299|NCT03638258|147519482|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.207|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from placebo at Week 4||||0.207
73987300|NCT03638258|147519482|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.004|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 6||||0.004
73987301|NCT03638258|147519482|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.022|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 6||||0.022
73987302|NCT03638258|147519482|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.003|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 8||||0.003
73987303|NCT03638258|147519482|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 8||||<0.001
73987304|NCT03638258|147519482|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||||||0.003|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 12||||0.003
73987305|NCT03638258|147519482|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.01||||||ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.|ANCOVA|||Difference from vehicle cream at Week 12||||0.01
73987306|NCT03638258|147519483|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.255|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 4||||0.255
73987307|NCT03638258|147519483|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.687|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream on Week 4||||0.687
73987308|NCT03638258|147519483|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.045|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 6||||0.045
73987309|NCT03638258|147519483|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.059|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 6||||0.059
73987310|NCT03638258|147519483|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.051|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 8||||0.051
73987311|NCT03638258|147519483|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.013|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 8||||0.013
73987312|NCT03638258|147519483|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.036|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 12||||0.036
73875405|NCT00796666|147292639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|1.21|||TWO_SIDED|95.0|-1.21|3.58|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12||3.58|-1.21|
73987313|NCT03638258|147519483|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 12||||0.001
73987314|NCT02109107|147519491|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|t=21.33; df=53||||||<.0001
73987315|NCT02109107|147519492|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|t=2.95; df=53||||||<0.05
73987316|NCT02109107|147519493|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||t-test, 2 sided|t+3.34; df=53||||||<0.005
73987317|NCT03302559|147519524|OTHER|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||<0.001
73987318|NCT03302559|147519525|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.005||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)||||0.005
73987319|NCT03302559|147519525|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)||||0.02
73987320|NCT03302559|147519525|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.0006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)||||0.0006
73987321|NCT03302559|147519525|OTHER|Testing hypothesis is that the mean change from baseline is zero||||||0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)||||0.001
73987322|NCT03302559|147519526|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)||||0.02
73987323|NCT03302559|147519526|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)||||0.006
73987324|NCT03302559|147519526|OTHER|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)||||<0.001
73987325|NCT03302559|147519526|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.5||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)||||0.5
73987326|NCT03302559|147519527|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.002||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.002
73987327|NCT03302559|147519528|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.0008||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.0008
73987328|NCT03302559|147519529|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.02
73987329|NCT03302559|147519534|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.3||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Normal Skin)||||0.3
73987330|NCT03302559|147519534|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.4||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Target Lesion)||||0.4
73987331|NCT03226106|147519573|SUPERIORITY||Mean Difference (Final Values)|930.51||||0.024|TWO_SIDED|95.0|41.65|1819.36||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1819.36|41.65|0.024
73987332|NCT03226106|147519574|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.584|TWO_SIDED|95.0|-0.67|2.07||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||2.07|-0.67|0.584
73987333|NCT03226106|147519575|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.724|TWO_SIDED|95.0|-1.4|1.32||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1.32|-1.40|0.724
73987334|NCT03226106|147519576|SUPERIORITY||Mean Difference (Final Values)|7.49||||0.547|TWO_SIDED|95.0|-18.9|33.89||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||33.89|-18.90|0.547
73987335|NCT03226106|147519577|SUPERIORITY||Mean Difference (Final Values)|4.93||||0.716|TWO_SIDED|95.0|-21.67|31.54||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||31.54|-21.67|0.716
73987336|NCT03226106|147519578|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.946|TWO_SIDED|95.0|-0.88|0.82||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||0.82|-0.88|0.946
73987337|NCT03226106|147519579|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.906|TWO_SIDED|95.0|-1.08|0.52||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||0.52|-1.08|0.906
73987338|NCT03226106|147519580|SUPERIORITY||Mean Difference (Final Values)|-1.55||||0.873|TWO_SIDED|95.0|-7.59|4.49||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.49|-7.59|0.873
73987339|NCT03226106|147519581|SUPERIORITY||Mean Difference (Final Values)|-6.26||||0.241|TWO_SIDED|95.0|-12.48|-0.04||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||-0.04|-12.48|0.241
73987340|NCT03226106|147519582|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.223|TWO_SIDED|95.0|-0.39|6.12||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||6.12|-0.39|0.223
73987341|NCT03226106|147519583|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.388|TWO_SIDED|95.0|-2.19|4.53||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.53|-2.19|0.388
73987342|NCT03226106|147519584|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.88|TWO_SIDED|95.0|-4.08|2.68||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||2.68|-4.08|0.88
73987343|NCT03226106|147519585|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.85|TWO_SIDED|95.0|-2.63|4.17||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.17|-2.63|0.85
73987344|NCT03226106|147519586|SUPERIORITY||Mean Difference (Final Values)|559.81||||0.101|TWO_SIDED|95.0|-405.01|1524.62||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1524.62|-405.01|0.101
73987345|NCT03712449|147519619|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0009|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0009
73987346|NCT03712449|147519619|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
73987347|NCT03712449|147519620|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.7878|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.7878
73987348|NCT03712449|147519620|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0349|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0349
73987349|NCT03712449|147519621|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0043|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0043
73987350|NCT03712449|147519621|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
73987351|NCT03712449|147519622|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0017|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0017
73987352|NCT03712449|147519622|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
73987353|NCT03712449|147519623|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0105|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0105
73987354|NCT03712449|147519623|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
73987355|NCT03712449|147519624|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0004|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0004
73987356|NCT03712449|147519624|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<.0001
73987357|NCT03712449|147519629|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0005|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0005
73987358|NCT03712449|147519629|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
74089773|NCT01169259|147732428|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.27|TWO_SIDED|95.0|0.83|1.95|||Regression, Cox|||||1.95|0.83|0.27
74089774|NCT01169259|147732428|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.198|TWO_SIDED|95.0|0.49|1.16|||Regression, Cox|||||1.16|0.49|0.198
73987359|NCT02166047|147519660|SUPERIORITY||Least Squares (LS) Mean Difference|0.023||||0.59|TWO_SIDED|95.0|-0.061|0.108||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.108|-0.061|0.590
73987360|NCT02166047|147519660|SUPERIORITY||LS Mean Difference|0.068||||0.12|TWO_SIDED|95.0|-0.018|0.154||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.154|-0.018|0.120
73987361|NCT02166047|147519660|SUPERIORITY||LS Mean Difference|0.017||||0.701|TWO_SIDED|95.0|-0.069|0.102||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.102|-0.069|0.701
73987362|NCT02166047|147519660|SUPERIORITY||LS Mean Difference|0.082||||0.21|TWO_SIDED|95.0|-0.046|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.046|0.210
73987363|NCT02166047|147519660|SUPERIORITY||LS Mean Difference|0.082||||0.207|TWO_SIDED|95.0|-0.046|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.046|0.207
73987364|NCT02166047|147519660|SUPERIORITY||LS Mean Difference|0.081||||0.216|TWO_SIDED|95.0|-0.048|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.048|0.216
73987365|NCT02166047|147519660|SUPERIORITY||LS Mean Difference|-0.015||||0.652|TWO_SIDED|95.0|-0.081|0.051||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.051|-0.081|0.652
73987366|NCT02166047|147519660|SUPERIORITY||LS Mean Difference|0.0||||0.994|TWO_SIDED|95.0|-0.066|0.065||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.065|-0.066|0.994
73987367|NCT02166047|147519660|SUPERIORITY||LS Mean Difference|0.0||||0.996|TWO_SIDED|95.0|-0.069|0.069||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.069|-0.069|0.996
74034900|NCT02065622|147622324|SUPERIORITY||Adjusted risk difference|2.3||||0.301|TWO_SIDED|95.0|-2.0|6.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||6.6|-2.0|0.301
74034901|NCT02065622|147622324|SUPERIORITY|||||||0.502|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.502
74034902|NCT02065622|147622325|SUPERIORITY||Adjusted risk difference|9.9||||0.069|TWO_SIDED|95.0|-0.8|20.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.6|-0.8|0.069
74034903|NCT02065622|147622325|SUPERIORITY|||||||0.085|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.085
74034904|NCT02065622|147622325|SUPERIORITY||Adjusted risk difference|10.3||||0.045|TWO_SIDED|95.0|0.2|20.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.4|0.2|0.045
74034905|NCT02065622|147622325|SUPERIORITY|||||||0.106|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.106
74089775|NCT01169259|147732429|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.58|TWO_SIDED|95.0|0.46|1.54|||Regression, Cox|||||1.54|0.46|0.58
73987368|NCT00451555|147519683|SUPERIORITY|||||||0.6238|||||||Fisher Exact|||||||0.6238
73987369|NCT00451555|147519683|SUPERIORITY|||||||0.6282|||||||Fisher Exact|||||||0.6282
73987370|NCT00451555|147519683|SUPERIORITY|||||||0.6242|||||||Fisher Exact|||||||0.6242
73987371|NCT00451555|147519684|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.6390
73987372|NCT00451555|147519684|SUPERIORITY|||||||0.6721|||||||Fisher Exact|||||||0.6721
73987373|NCT00451555|147519684|SUPERIORITY|||||||0.6349|||||||Fisher Exact|||||||0.6349
73987374|NCT00451555|147519685|SUPERIORITY|||||||0.8582|||||||Log Rank|||||||0.8582
73987375|NCT00451555|147519685|SUPERIORITY|||||||0.7307|||||||Log Rank|||||||0.7307
73987376|NCT00451555|147519685|SUPERIORITY|||||||0.9798|||||||Log Rank|||||||0.9798
73987377|NCT00451555|147519686|SUPERIORITY|||||||0.5887|||||||Log Rank|||||||0.5887
73987378|NCT00451555|147519686|SUPERIORITY|||||||0.4516|||||||Log Rank|||||||0.4516
73987379|NCT00451555|147519686|SUPERIORITY|||||||0.7965|||||||Log Rank|||||||0.7965
73987380|NCT00922441|147519691|OTHER|Efficacy, Safety|||||<|0.05|||||||ANOVA|comparison between the groups||||||<0.05
73987381|NCT02973477|147519696|OTHER|Mixed effects model|Coefficient|0.28||||0.28|TWO_SIDED|95.0|-0.24|0.8||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted mixed models analysis for both periods, both arms, comparing each treatment's change.||0.8|-0.24|0.28
73987382|NCT02973477|147519697|OTHER||Coefficient|-0.003||||0.97|TWO_SIDED|95.0|-0.16|0.15||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis to compare the difference between the values from baseline to 12 weeks between each intervention for SDNN.||0.15|-0.16|0.97
74089776|NCT01169259|147732429|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.6|2.01|||Regression, Cox|||||2.01|0.60|0.76
74089777|NCT01169259|147732430|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.56|TWO_SIDED|95.0|0.71|1.2|||Regression, Cox|||||1.20|0.71|0.56
74089778|NCT01169259|147732430|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.014|TWO_SIDED|95.0|0.55|0.93|||Regression, Cox|||||0.93|0.55|0.014
74089779|NCT01169259|147732431|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.92|1.27||||||||1.27|0.92|
74089780|NCT01169259|147732431|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.83|1.15||||||||1.15|0.83|
74089781|NCT01169259|147732432|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.82|1.26||||||||1.26|0.82|
74089782|NCT01169259|147732432|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
74089783|NCT03959527|147732453|NON_INFERIORITY|A single oral 3 g dose of zoliflodacin would be considered as non-inferior to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin if the upper bound of the 2-sided 95% CI for the microbiological cure rate of the combination therapy minus zoliflodacin was less than 12% (prespecified non-inferiority \[NI\] margin for the primary endpoint).|Risk Difference (RD)|5.31|||||TWO_SIDED|95.0|1.38|8.65|||||95% CI of the treatment difference of ceftriaxone+ azithromycin combination minus zoliflodacin|Point estimate for the treatment difference in proportion of ceftriaxone/azithromycin combination and zoliflodacin with microbiological cure and 2-sided 95% CI calculated by Newcombe score method.||8.65|1.38|
73987383|NCT02973477|147519697|OTHER||Coefficient|-0.02||||0.79|TWO_SIDED|95.0|-0.21|0.16||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis to compare the difference between the values from baseline to 12 weeks between each intervention for rmsSD.||0.16|-0.21|0.79
73987384|NCT02973477|147519698|OTHER||Coefficient|0.01||||0.58|TWO_SIDED|95.0|-0.02|0.04||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of EI ratio.||0.04|-0.02|0.58
73987385|NCT02973477|147519698|OTHER||Coefficient|0.02||||0.58|TWO_SIDED|95.0|-0.05|0.09||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for Valsalva ratio.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis for both periods, both arms, comparing each treatment's change of Valsalva ratio.||0.09|-0.05|0.58
73987386|NCT02973477|147519698|OTHER||Coefficient|-0.01||||0.56|TWO_SIDED|95.0|-0.05|0.03||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for 30:15 ratio.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of 30:15 ratio.||0.03|-0.05|0.56
73987387|NCT02973477|147519699|OTHER||Coefficient|0.01||||0.92|TWO_SIDED|95.0|-0.23|0.25||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of BNP.||0.25|-0.23|0.92
74089784|NCT03692312|147732489|SUPERIORITY||Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|0.875||0.0514|TWO_SIDED|95.0|-0.01|3.51|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||3.51|-0.01|0.0514
74089785|NCT03692312|147732490|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.268||0.2124|TWO_SIDED|95.0|-0.2|0.88|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.88|-0.20|0.2124
74089786|NCT03692312|147732491|SUPERIORITY||Mean Difference (Final Values)|4.74|STANDARD_ERROR_OF_MEAN|1.104|<|0.0001|TWO_SIDED|95.0|2.51|6.96|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||6.96|2.51|<0.0001
74089787|NCT03692312|147732492|SUPERIORITY||Mean Difference (Final Values)|3.18|STANDARD_ERROR_OF_MEAN|1.099||0.0059|TWO_SIDED|95.0|0.96|5.39|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||5.39|0.96|0.0059
74089788|NCT03692312|147732493|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.4634|TWO_SIDED|95.0|-0.3|0.14|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.14|-0.30|0.4634
74089789|NCT03692312|147732494|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.564||0.5385|TWO_SIDED|95.0|-1.49|0.79|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.79|-1.49|0.5385
74089790|NCT03692312|147732497|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.764||0.711|TWO_SIDED|95.0|-1.26|1.83|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||1.83|-1.26|0.7110
73987388|NCT01318538|147519701|SUPERIORITY_OR_OTHER|||||||0.821|TWO_SIDED|95.0|||||loglinear (negative binomial) regression|Analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (relative changes i.e. % change)||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores. With a total of 100 women, the study was adequately powered to detect a minimum 5 day benefit in the # of days of any substance use (power = 83%).||||0.821
73987389|NCT01318538|147519702|SUPERIORITY_OR_OTHER|||||||0.519|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001 reductions in mean # of alcohol use days during treatment (9.9 and 12.4 day reductions for WRG and GDC respectively) and at 6 months post-treatment (8.3 and 12.2 day reductions).||||0.519
73987390|NCT01318538|147519703|SUPERIORITY_OR_OTHER|||||||0.253|TWO_SIDED|95.0|||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).||||0.253
73987391|NCT01318538|147519704|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED|95.0|||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).||||0.667
73987392|NCT01318538|147519706|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73987393|NCT01318538|147519707|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73987394|NCT01318538|147519708|SUPERIORITY_OR_OTHER|||||||0.464|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.05) reductions in mean number of drug use days during treatment (3.0 and 1.5 day reductions for WRG and GDC respectively); however at 6 months post-treatment, the reductions were significant for WRG (2.8 day reduction; p\<0.05) but not for GDC (1.5 day reduction; p\>0.01).||||0.464
73987395|NCT01318538|147519709|SUPERIORITY_OR_OTHER|||||||0.904|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001) reductions in mean number of heavy drinking days during treatment (8.6 and 12.1 days reduction for WRG and GDC, respectively) and at 6 months post-treatment (8.0 and 11.8 day reductions).||||0.904
73987396|NCT01318538|147519710|SUPERIORITY_OR_OTHER|||||||0.799|||||||linear mixed effect model|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment by phase interaction. Note: Women in both the WRG and GDC groups had significant (p\<0.05) reductions in mean number of drinks per drinking day only during the in treatment phase (2.0 and 2.9 reductions for WRG and GDC, respectively).||||0.799
73987397|NCT00991029|147519711|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.02|TWO_SIDED|95.0|0.59|0.95|||Log Rank|||||0.95|0.59|0.02
73987398|NCT00991029|147519712|SUPERIORITY||Hazard Ratio (HR)|2.32||||0.02|TWO_SIDED|95.0|1.1|4.87|||Log Rank|||||4.87|1.10|0.02
73987399|NCT00991029|147519713|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.01|TWO_SIDED|95.0|0.56|0.92|||Log Rank|||||0.92|0.56|0.01
73987400|NCT00991029|147519714|SUPERIORITY||Hazard Ratio (HR)|1.44||||0.46|TWO_SIDED|95.0|0.55|3.78|||Log Rank|||||3.78|0.55|0.46
73987401|NCT00991029|147519715|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.52|TWO_SIDED|95.0|0.43|5.35|||Log Rank|||||5.35|0.43|0.52
73987402|NCT00991029|147519716|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.01|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||||0.94|0.58|0.01
73987403|NCT00991029|147519717|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.13|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.13
73987404|NCT00991029|147519718|SUPERIORITY||Hazard Ratio (HR)|1.68||||0.47|TWO_SIDED|95.0|0.4|7.03|||Log Rank|||||7.03|0.4|0.47
73987405|NCT00991029|147519719|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.14|7.14|||Log Rank|||||7.14|0.14|0.99
73987406|NCT00991029|147519720|SUPERIORITY|||||||0.16|||||||Log Rank|||||||0.16
74034906|NCT02065622|147622326|SUPERIORITY||Adjusted risk difference|4.2||||0.181|TWO_SIDED|95.0|-2.0|10.5|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||10.5|-2.0|0.181
74034907|NCT02065622|147622326|SUPERIORITY||Adjusted risk difference|3.8||||0.2|TWO_SIDED|95.0|-2.0|9.7|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||9.7|-2.0|0.200
73987407|NCT00991029|147519721|SUPERIORITY||Hazard Ratio (HR)|2.45||||0.04|TWO_SIDED|95.0|1.01|5.9|||Log Rank|||||5.9|1.01|0.04
73987408|NCT00991029|147519722|SUPERIORITY||Hazard Ratio (HR)|3.12|||<|0.001|TWO_SIDED|95.0|1.67|5.83|||Log Rank|||||5.83|1.67|<0.001
73987409|NCT00991029|147519723|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.27|TWO_SIDED|95.0|0.73|3.13|||Log Rank|||||3.13|0.73|0.27
73987410|NCT02487251|147519734|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|-0.15||||0.34|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in BMIz is p = .34.|Mixed Models Analysis||The reported estimation parameter is the effect size (cohen's d) for the change in BMIz (particularly in the Phase 2 sample)|We tested change in BMIz for each of the four study arms/groups.||||.34
73987411|NCT02487251|147519735|EQUIVALENCE|Sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|-0.07||||0.62|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in observed fruit intake is p = .62.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested change in observed fruit intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups.||||.62
73987412|NCT02487251|147519736|EQUIVALENCE|Sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|0.4||||0.009|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in observed vegetable intake is p = .009.|Mixed Models Analysis|||We tested pre to post change in observed vegetable intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups. Positive Observed dietary quality data was not collected in Phase 1.||||.009
73987413|NCT02487251|147519737|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, enabled detection of small-medium effect sizes, d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes, power of 80%, α = .05. Phase 1 analyses included paired t-tests \& examination of pre-post effect size change. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|0.15||||0.21|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in parent reported fruit is p = .21.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested pre to post change in parent reported child fruit intake for each of the four study arms/groups.||||.21
73987414|NCT02487251|147519738|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, enabled detection of small-medium effect sizes, d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes, power of 80%, α = .05. Phase 1 analyses included paired t-tests \& examination of pre-post effect size change. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|0.07||||0.55|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in parent reported vegetables is p = .55.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested change in vegetable intake for each of the four study arms/groups.||||.55
73987415|NCT02487251|147519739|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|-0.02||||0.84|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in mealtime frequency is p = .84.|Mixed Models Analysis|||We tested change in frequency of family mealtimes for each of the four study arms/groups.||||.84
73987416|NCT00570921|147519754|SUPERIORITY_OR_OTHER||Median Time to Progression|7.4|||||TWO_SIDED|95.0|1.9|12.1||||||We hypothesized that median time to progression (TTP) in our trial will increase from 3.7 months for the historical fulvestrant-only control to 7.0 months on the combination of fulvestrant and everolimus in the current trial. A sample of 40 evaluable patients was calculated to show the increase in TTP with 80% power and 5% significance level based on a two sided test of differences in survival times between historical controls and treated group.||12.1|1.9|
74034908|NCT02065622|147622327|SUPERIORITY||Adjusted risk difference|3.0||||0.3|TWO_SIDED|95.0|-2.6|8.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.6|-2.6|0.300
74034909|NCT02065622|147622327|SUPERIORITY||Adjusted risk difference|3.1||||0.254|TWO_SIDED|95.0|-2.2|8.4|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.4|-2.2|0.254
74034910|NCT02065622|147622328|SUPERIORITY||Adjusted risk difference|6.5||||0.05|TWO_SIDED|95.0|0.0|13.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||13.1|-0.0|0.050
73987417|NCT00570921|147519755|SUPERIORITY_OR_OTHER||Response Rate Percentage|12.9|||||TWO_SIDED|95.0|3.63|29.83|||||Percentage of Patients with a complete or partial response with 95% exact binomial proportion confidence interval|||29.83|3.63|
73987418|NCT00570921|147519756|SUPERIORITY_OR_OTHER||Percentage with clinical benefit|48.39|||||TWO_SIDED|95.0|30.15|66.94|||||Percentage of patients that had a complete response, partial response, or stable disease for 24 weeks or more as defined by RECIST v1.0.|||66.94|30.15|
73875406|NCT00796666|147292639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.71|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|0.37|5.05|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12||5.05|0.37|
74034911|NCT02065622|147622328|SUPERIORITY||Adjusted risk difference|4.8||||0.131|TWO_SIDED|95.0|-1.4|11.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||11.0|-1.4|0.131
73875407|NCT00796666|147292639|SUPERIORITY_OR_OTHER|||||||0.2897|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2897
73875408|NCT00796666|147292640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.05|1.38|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12||1.38|-2.05|
73875409|NCT00796666|147292640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|0.46|3.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12||3.82|0.46|
73987419|NCT00784277|147519762|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|55.1|STANDARD_ERROR_OF_MEAN|20.37||0.007||95.0|15.11|95.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||95.13|15.11|0.007
73987420|NCT00784277|147519762|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|63.4|STANDARD_ERROR_OF_MEAN|20.23||0.004||95.0|23.67|103.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||103.13|23.67|0.004
73987421|NCT00784277|147519763|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|3.1|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|2.22|4.01||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||4.01|2.22|<0.001
74034912|NCT02065622|147622329|SUPERIORITY||Adjusted risk difference|7.3||||0.035|TWO_SIDED|95.0|0.5|14.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||14.1|0.5|0.035
73987422|NCT00784277|147519763|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|2.2|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|1.34|3.12||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||3.12|1.34|<0.001
73987423|NCT00784277|147519763|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|1.6|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|0.72|2.5||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||2.50|0.72|<0.001
74034913|NCT02065622|147622329|SUPERIORITY||Adjusted risk difference|8.7||||0.008|TWO_SIDED|95.0|2.3|15.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||15.1|2.3|0.008
73987424|NCT01187407|147519779|SUPERIORITY_OR_OTHER|||||||0.997||||||Primary comparison.|Mixed Models Analysis|||||||0.997
73987425|NCT01187407|147519779|SUPERIORITY_OR_OTHER|||||||0.769||||||Secondary comparison.|Mixed Models Analysis|||||||0.769
73987426|NCT02831998|147519806|NON_INFERIORITY|Investigational product upper bounds must be less than 0.5.|Median Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.188|0.083||||||Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.083|-0.188|
74039572|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0003|TWO_SIDED|95.0|1.3|2.39|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.30|0.0003
73875410|NCT00796666|147292640|SUPERIORITY_OR_OTHER|||||||0.0179|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0179
73875411|NCT01217463|147292645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.4109|TWO_SIDED|95.0|0.6|3.43|||Regression, Logistic|||||3.43|0.60|0.4109
73875412|NCT01217463|147292646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|0.78|2.4|||Regression, Logistic|||||2.4|0.78|
73875413|NCT00945282|147292714|SUPERIORITY||Mean Difference (Final Values)|-0.932||||0.042|TWO_SIDED|95.0|-1.812|-0.053|||ANCOVA|||||-0.053|-1.812|0.042
73875414|NCT00945282|147292715|SUPERIORITY||Mean Difference (Final Values)|-0.413||||0.221|TWO_SIDED|95.0|-1.173|0.347|||ANCOVA|||||0.347|-1.173|0.221
73875415|NCT00945282|147292716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value is the value for GSK2248761 30 mg, at Day 1 to Day 8|Mixed Models Analysis|||Day 1 to Day 8||||<0.0001
73987427|NCT02831998|147519806|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Median Difference (Final Values)|2.627|||||TWO_SIDED|95.0|2.396|2.858||||||Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.858|2.396|
73987428|NCT02831998|147519807|NON_INFERIORITY|Investigational product average treatment effect upper bounds cannot be more than 0.5.|Mean Difference (Final Values)|-0.018|||||TWO_SIDED|95.0|-0.102|0.065||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.065|-0.102|
73987429|NCT02831998|147519807|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|1.909|||||TWO_SIDED|95.0|1.766|2.053||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.053|1.766|
73875416|NCT00945282|147292716|SUPERIORITY_OR_OTHER|||||||0.6922||||||The p-value is the value for placebo, at Day 1 to Day 8|Mixed Models Analysis|||Placebo, Day 1 to Day 8||||0.6922
73987430|NCT05324007|147519808|EQUIVALENCE|Estimated effect size was based on Liberman et al. (2017) that found a partial eta squared of .478 for the interaction between different-language and same-language conditions. Using G\*power using an alpha of .05, our target sample size of 30 per condition should provide 99.73% power to detect the main effect in the White-White and Black-Black condition and 99.99% power to detect the main effect in the Black-White condition.|partial eta squared|0.062|||<|0.05|TWO_SIDED||||||ANOVA|||We will examine whether looking time at affiliation will be greater when looking at Black-White interactions than at White-White or Black-Black interactions. That is, we will test if infants will be more surprised (look longer) by affiliation between different-race people interacting than same race people interacting. We will conduct a mixed ANOVA with conditions (Black-White, White-White, Black-Black) as a between-subject and test type (affiliation vs. disengagement) as within-subject factors.||||<.05
73987431|NCT02630706|147519814|SUPERIORITY|Constrained longitudinal data analysis (cLDA)|Difference in the LSM vs. placebo|-0.69|||<|0.001|TWO_SIDED|95.0|-0.85|-0.52||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA|Least squares means = LSM||The primary hypothesis of the study was the mean change from baseline in HbA1c for 15 mg ertugliflozin is greater than that for placebo.||-0.52|-0.85|<0.001
73987432|NCT02630706|147519814|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.8|||<|0.001|TWO_SIDED|95.0|-0.97|-0.63|||cLDA|||The primary hypothesis of the study was the mean change from baseline in HbA1c for 5 mg ertugliflozin is greater than that for placebo.||-0.63|-0.97|<0.001
73987433|NCT02630706|147519815|SUPERIORITY||Difference in the LSM vs. placebo|-0.68|||<|0.001|TWO_SIDED|95.0|-0.86|-0.5||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA|||||-0.50|-0.86|<0.001
73987434|NCT02630706|147519815|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.76|||<|0.001|TWO_SIDED|95.0|-0.95|-0.58|||cLDA|||||-0.58|-0.95|<0.001
73987435|NCT02630706|147519816|OTHER||Difference in % vs. Placebo|-6.0|||||TWO_SIDED|95.0|-16.5|4.6|||||||Miettinen-Nurminen method|4.6|-16.5|
73987436|NCT02630706|147519816|OTHER||Difference in % vs. Placebo|-2.8|||||TWO_SIDED|95.0|-13.3|7.7|||||||Miettinen-Nurminen method|7.7|-13.3|
73987437|NCT02630706|147519817|OTHER||Difference in % vs. Placebo|-8.9|||||TWO_SIDED|95.0|-20.5|3.0|||||||Miettinen-Nurminen method|3.0|-20.5|
73987438|NCT02630706|147519817|OTHER||Difference in % vs. Placebo|-4.8|||||TWO_SIDED|95.0|-16.5|6.9|||||||Miettinen-Nurminen method|6.9|-16.5|
73987439|NCT02630706|147519820|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-27.78|||<|0.001|TWO_SIDED|95.0|-33.85|-21.7|||cLDA|||||-21.70|-33.85|<0.001
73987440|NCT02630706|147519820|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-30.4|||<|0.001|TWO_SIDED|95.0|-36.45|-24.35|||cLDA|||||-24.35|-36.45|<0.001
73987441|NCT02630706|147519821|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-26.21|||<|0.001|TWO_SIDED|95.0|-32.41|-20.01|||cLDA|||||-20.01|-32.41|<0.001
74034914|NCT02065622|147622330|SUPERIORITY||Adjusted risk difference|3.2||||0.16|TWO_SIDED|95.0|-1.3|7.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.6|-1.3|0.160
74034915|NCT02065622|147622330|SUPERIORITY||Adjusted risk difference|2.9||||0.166|TWO_SIDED|95.0|-1.2|7.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.1|-1.2|0.166
73875417|NCT03101566|147292732|OTHER||||||||||||||||||PFS at 6 months was estimated for this trial using the product-limit method of Kaplan and Meier with 95% confidence intervals calculated using Greenwood's formula. All statistical analyses were completed using the SAS System, v9.4 \[Cary, NC, USA\].|||
73987442|NCT02630706|147519821|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-28.55|||<|0.001|TWO_SIDED|95.0|-34.67|-22.43|||cLDA|||||-22.43|-34.67|<0.001
73987443|NCT02630706|147519822|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.0|||<|0.001|TWO_SIDED|95.0|-2.51|-1.5|||cLDA|||||-1.50|-2.51|<0.001
73987444|NCT02630706|147519822|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.78|||<|0.001|TWO_SIDED|95.0|-2.28|-1.28|||cLDA|||||-1.28|-2.28|<0.001
73987445|NCT02630706|147519823|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.05|||<|0.001|TWO_SIDED|95.0|-2.63|-1.21|||cLDA|||||-1.21|-2.63|<0.001
74034916|NCT02065622|147622331|SUPERIORITY||Adjusted risk difference|8.3||||0.011|TWO_SIDED|95.0|1.9|14.7|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||14.7|1.9|0.011
74034917|NCT02065622|147622331|SUPERIORITY||Adjusted risk difference|7.0||||0.025|TWO_SIDED|95.0|0.9|13.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||13.0|0.9|0.025
74034918|NCT02065622|147622332|SUPERIORITY||Adjusted risk difference|4.2||||0.218|TWO_SIDED|95.0|-2.5|10.9|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||10.9|-2.5|0.218
74034919|NCT02065622|147622332|SUPERIORITY||Adjusted risk difference|2.4||||0.456|TWO_SIDED|95.0|-4.0|8.8|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.8|-4.0|0.456
74034920|NCT02065622|147622333|SUPERIORITY||Adjusted risk difference|9.5||||0.098|TWO_SIDED|95.0|-1.7|20.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.8|-1.7|0.098
74034921|NCT02065622|147622333|SUPERIORITY||Adjusted risk difference|9.9||||0.066|TWO_SIDED|95.0|-0.7|20.5|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.5|-0.7|0.066
74034922|NCT02065622|147622334|SUPERIORITY||Adjusted risk difference|21.5||||0.002|TWO_SIDED|95.0|7.6|35.4|||Cochran-Mantel-Haenszel|Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.||Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||35.4|7.6|0.002
74089791|NCT03692312|147732498|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.326||0.7861|TWO_SIDED|95.0|-0.57|0.75|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.75|-0.57|0.7861
74089792|NCT03692312|147732499|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.123||0.6282|TWO_SIDED|95.0|-0.19|0.31|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. A compound symmetry variance-covariance matrix has been used.||0.31|-0.19|0.6282
73987446|NCT02630706|147519823|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.79|||<|0.001|TWO_SIDED|95.0|-2.36|-1.21|||cLDA|||||-1.21|-2.36|<0.001
73987447|NCT02630706|147519824|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.56|||<|0.001|TWO_SIDED|95.0|2.49|8.35|||Logistic regression model|||||8.35|2.49|<0.001
74089793|NCT03692312|147732500|SUPERIORITY|||||||0.0428|||||||t-test, 2 sided|||||||0.0428
73875418|NCT01623115|147292758|SUPERIORITY_OR_OTHER||LS mean difference|-57.9|||<|0.0001|TWO_SIDED|95.0|-63.3|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-52.6|-63.3|<0.0001
73987448|NCT02630706|147519824|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.59|||<|0.001|TWO_SIDED|95.0|2.52|8.36|||Logistic regression model|||||8.36|2.52|<0.001
73987449|NCT02630706|147519825|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.49|||<|0.001|TWO_SIDED|95.0|2.32|8.68|||Logistic regression model|||||8.68|2.32|<0.001
73987450|NCT02630706|147519825|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|3.47|||<|0.001|TWO_SIDED|95.0|1.77|6.8|||Logistic regression model|||||6.80|1.77|<0.001
73987451|NCT02630706|147519826|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.09|||<|0.001|TWO_SIDED|95.0|-6.48|-1.69|||cLDA|||||-1.69|-6.48|<0.001
73987452|NCT02630706|147519826|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-5.3|||<|0.001|TWO_SIDED|95.0|-7.68|-2.92|||cLDA|||||-2.92|-7.68|<0.001
73987453|NCT02630706|147519827|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-2.64||||0.058|TWO_SIDED|95.0|-5.36|0.09|||cLDA|||||0.09|-5.36|0.058
73987454|NCT02630706|147519827|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.08||||0.003|TWO_SIDED|95.0|-6.78|-1.39|||cLDA|||||-1.39|-6.78|0.003
73987455|NCT02630706|147519828|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.4||||0.086|TWO_SIDED|95.0|-3.0|0.2|||cLDA|||||0.20|-3.00|0.086
73987456|NCT02630706|147519828|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.42||||0.081|TWO_SIDED|95.0|-3.01|0.17|||cLDA|||||0.17|-3.01|0.081
73987457|NCT02630706|147519829|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-0.95||||0.315|TWO_SIDED|95.0|-2.8|0.9|||cLDA|||||0.90|-2.80|0.315
73987458|NCT02630706|147519829|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.0||||0.282|TWO_SIDED|95.0|-2.83|0.83|||cLDA|||||0.83|-2.83|0.282
73987459|NCT02630706|147519830|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.9||||0.001|TWO_SIDED|95.0|2.46|32.22||Nominal p-values were provided.|Logistic regression model|||||32.22|2.46|0.001
73987460|NCT02630706|147519830|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|10.69|||<|0.001|TWO_SIDED|95.0|2.95|38.71||Nominal p-values were provided.|Logistic regression model|||||38.71|2.95|<0.001
73987461|NCT02630706|147519831|SUPERIORITY|Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.34|||<|0.001|TWO_SIDED|95.0|2.52|27.6||Nominal p-values were provided.|Logistic regression model|||||27.60|2.52|<0.001
73987462|NCT02630706|147519831|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.29|||<|0.001|TWO_SIDED|95.0|2.44|28.11||Nominal p-values were provided.|Logistic regression model|||||28.11|2.44|<0.001
73987463|NCT02630706|147519832|OTHER||Difference in % (Ert. 15 mg. - placebo)|-9.0|||<|0.001||95.0|-14.5|-5.0|||Miettinen & Nurminen method|Miettinen \& Nurminen method stratified by country ('China' or 'other') for the overall population.||||-5.0|-14.5|<0.001
73987464|NCT02630706|147519832|OTHER||Difference in % (Ert. 5 mg. - placebo)|-8.4|||<|0.001|TWO_SIDED|95.0|-14.0|-4.4|||Miettinen & Nurminen method|Miettinen \& Nurminen method stratified by country ('China' or 'other') for the overall population.||||-4.4|-14.0|<0.001
74089794|NCT03692312|147732501|SUPERIORITY||Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.094||0.0379|TWO_SIDED|95.0|0.6|0.98|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.98|0.60|0.0379
73987465|NCT02630706|147519833|OTHER||Difference in % (Ert. 15 mg. - placebo)|-8.9||||0.001||95.0|-15.1|-4.2|||Miettinen & Nurminen method|||||-4.2|-15.1|0.001
73987466|NCT02630706|147519833|OTHER||Difference in % (Ert. 5 mg. - placebo)|-9.6|||<|0.001|TWO_SIDED|95.0|-15.8|-5.7|||Miettinen & Nurminen method|||||-5.7|-15.8|<0.001
73987467|NCT03790878|147519879|OTHER|||||||0.018|||||||ANCOVA|||||||0.018
73987468|NCT03790878|147519880|OTHER|||||||0.396|||||||Multilevel modeling|||||||0.396
73987469|NCT03790878|147519881|OTHER|||||||0.002|||||||Multilevel modeling|||||||0.002
73987470|NCT00607789|147519894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_DEVIATION|1.7|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups. The same analysis was applied to binge episode frequency, weight, BMI, and scores on the CGI-Severity, YBOCS-BE, and IDS scales. The difference in rate of change was estimated by random regression methods||||<0.05
73987471|NCT01196741|147519945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.57|TWO_SIDED|95.0|0.65|1.23|||Regression, Cox|||||1.23|0.65|0.57
73987472|NCT01196741|147519946|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Cox|||||||0.81
73987473|NCT01196741|147519949|SUPERIORITY_OR_OTHER|||||||0.0476|||||||Mixed Models Analysis|||||||0.0476
73987474|NCT01196741|147519951|SUPERIORITY_OR_OTHER|||||||0.99|||||||Regression, Cox|||||||0.99
73987475|NCT01064856|147519961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Pearson's chi-square|||||||0.006
73987476|NCT01064856|147519963|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||<0.001
73987477|NCT01064856|147519964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||0.003
73987478|NCT01064856|147519965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||0.051
73987479|NCT02273180|147519975|NON_INFERIORITY|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 \& Humalog was \<0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure:if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested, demonstrated if lower bound of 2-sided 95%CI of difference between SAR342434 \& Humalog was \>-0.3%.|Least Square (LS) Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|95.0|-0.084|0.197|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visits and treatment-by-visit interaction as fixed categorical effects, and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.||0.197|-0.084|
73987480|NCT05294328|147520036|SUPERIORITY||Odds Ratio (OR)|34.262|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
73987481|NCT05294328|147520036|SUPERIORITY||Odds Ratio (OR)|73.443|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
73987482|NCT02056873|147520037|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.05|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||"At 6 months post-surgery the YGTSS scores of each subjects is statistically tested against their baseline scores.~A decrease in this tic severity scale means that the severity of the tics have reduced.~Hence, we performed a superiority test, which statistically verifies if the reduction in the tic severity scale was meaningful."||||0.05
73987483|NCT00113269|147520048|SUPERIORITY_OR_OTHER||differences in event rates|-3.3||||0.4889|TWO_SIDED|95.305|-12.7|6.1|||Normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.|||6.1|-12.7|0.4889
73987484|NCT00113269|147520048|SUPERIORITY_OR_OTHER||differences in event rates|-15.7|||<|0.0001|TWO_SIDED|95.305|-21.9|-9.4|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.|||-9.4|-21.9|<0.0001
73987485|NCT00113269|147520049|SUPERIORITY_OR_OTHER||differences in event rates|2.7||||0.6533|TWO_SIDED|95.0|-9.0|14.3|||normal approximation|||||14.3|-9.0|0.6533
73987486|NCT00113269|147520049|SUPERIORITY_OR_OTHER||differences in event rates|-11.9||||0.0024|TWO_SIDED|95.0|-19.5|-4.2|||normal approximation|||||-4.2|-19.5|0.0024
73987487|NCT00113269|147520050|SUPERIORITY_OR_OTHER||differences in event rates|-6.1||||0.4087|TWO_SIDED|95.0|-20.7|8.4|||normal approximation|||||8.4|-20.7|0.4087
74089795|NCT03692312|147732503|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline; two-tailed t-test assuming unequal variance.||||0.078
73987488|NCT00113269|147520050|SUPERIORITY_OR_OTHER||differences in event rates|-8.7||||0.0456|TWO_SIDED|95.0|-17.2|-0.2|||normal approximation|||||-0.2|-17.2|0.0456
73987489|NCT00113269|147520051|SUPERIORITY_OR_OTHER||differences in event rates|1.1||||0.8742|TWO_SIDED|95.0|-12.7|15.0|||normal approximation|||||15.0|-12.7|0.8742
73987490|NCT00113269|147520051|SUPERIORITY_OR_OTHER||differences in event rates|-14.1||||0.001|TWO_SIDED|95.0|-22.5|-5.7|||normal approximation|||||-5.7|-22.5|0.0010
73987491|NCT00113269|147520053|SUPERIORITY_OR_OTHER||differences in event rates|3.5||||0.4134|TWO_SIDED|95.0|-4.8|11.7|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||11.7|-4.8|0.4134
73987492|NCT00113269|147520053|SUPERIORITY_OR_OTHER||differences in event rates|2.4||||0.2459|TWO_SIDED|95.0|-1.7|6.5|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||6.5|-1.7|0.2459
73875419|NCT01623115|147292759|SUPERIORITY_OR_OTHER||LS mean difference|-58.1|||<|0.0001|TWO_SIDED|95.0|-63.5|-52.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-52.7|-63.5|<0.0001
73875420|NCT01623115|147292760|SUPERIORITY_OR_OTHER||LS mean difference|-49.2|||<|0.0001|TWO_SIDED|95.0|-53.9|-44.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.5|-53.9|<0.0001
73875421|NCT01623115|147292761|SUPERIORITY_OR_OTHER||LS mean difference|-49.5|||<|0.0001|TWO_SIDED|95.0|-54.2|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)||-44.8|-54.2|<0.0001
73875422|NCT01623115|147292762|SUPERIORITY_OR_OTHER||LS mean difference|-45.8|||<|0.0001|TWO_SIDED|95.0|-49.8|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.8|-49.8|<0.0001
73875423|NCT01623115|147292763|SUPERIORITY_OR_OTHER||LS mean difference|-45.9|||<|0.0001|TWO_SIDED|95.0|-49.9|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.8|-49.9|<0.0001
73987493|NCT00113269|147520054|SUPERIORITY_OR_OTHER||differences in event rates|6.0||||0.3155|TWO_SIDED|95.0|-5.7|17.6|||normal approximation|||||17.6|-5.7|0.3155
73987494|NCT00113269|147520054|SUPERIORITY_OR_OTHER||differences in event rates|-0.4||||0.9045|TWO_SIDED|95.0|-6.5|5.7|||normal approximation|||||5.7|-6.5|0.9045
73987495|NCT00113269|147520055|SUPERIORITY_OR_OTHER||differences in event rates|1.6||||0.5265|TWO_SIDED|95.0|-3.4|6.7|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||6.7|-3.4|0.5265
73987496|NCT00113269|147520055|SUPERIORITY_OR_OTHER||differences in event rates|-0.6||||0.682|TWO_SIDED|95.0|-3.4|2.2|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||2.2|-3.4|0.6820
73987497|NCT00113269|147520056|SUPERIORITY_OR_OTHER||differences in event rates|5.9||||0.1797|TWO_SIDED|95.0|-2.7|14.4|||normal approximation|||||14.4|-2.7|0.1797
73987498|NCT00113269|147520056|SUPERIORITY_OR_OTHER||differences in event rates|-1.4||||0.5655|TWO_SIDED|95.0|-6.3|3.4|||normal approximation|||||3.4|-6.3|0.5655
73987499|NCT00113269|147520057|SUPERIORITY_OR_OTHER|||||||0.4735||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.4735
74039573|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.57|2.87|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.87|1.57|<.0001
73987500|NCT00113269|147520057|SUPERIORITY_OR_OTHER|||||||0.1186||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.1186
73987501|NCT00113269|147520058|SUPERIORITY_OR_OTHER|||||||0.5231||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.5231
73987502|NCT00113269|147520058|SUPERIORITY_OR_OTHER|||||||0.122||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.1220
73987503|NCT01644188|147520090|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-34.4|-25.3||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-25.3|-34.4|<0.0001
73987504|NCT01644188|147520091|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.6|||<|0.0001|TWO_SIDED|95.0|-34.9|-26.2||Threshold for significance ≤0.05|Mixed Models Analysis||Alirocumab vs. ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-26.2|-34.9|<0.0001
73987505|NCT01644188|147520092|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.4|||<|0.0001|TWO_SIDED|95.0|-33.7|-25.1||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.1|-33.7|<0.0001
73875424|NCT01623115|147292764|SUPERIORITY_OR_OTHER||LS mean difference|-52.4|||<|0.0001|TWO_SIDED|95.0|-57.2|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.6|-57.2|<0.0001
73875425|NCT01623115|147292765|SUPERIORITY_OR_OTHER||LS mean difference|-52.6|||<|0.0001|TWO_SIDED|95.0|-57.5|-47.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.8|-57.5|<0.0001
73875426|NCT01623115|147292766|SUPERIORITY_OR_OTHER||LS mean difference|-38.7|||<|0.0001|TWO_SIDED|95.0|-42.4|-35.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35|-42.4|<0.0001
73875427|NCT01623115|147292767|SUPERIORITY_OR_OTHER||LS mean difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-41.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.9|-41.2|<0.0001
73875428|NCT01623115|147292768|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.7|||<|0.0001|TWO_SIDED|95.0|-48.0|-39.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.4|-48|<0.0001
73987506|NCT01644188|147520093|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.7|||<|0.0001|TWO_SIDED|95.0|-33.8|-25.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.6|-33.8|<0.0001
73987507|NCT01644188|147520094|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|95.0|-26.0|-18.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.8|-26|<0.0001
73987508|NCT01644188|147520095|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-26.5|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.6|-26.5|<0.0001
73987509|NCT01644188|147520096|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.9|||<|0.0001|TWO_SIDED|95.0|-26.9|-18.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.9|-26.9|<0.0001
73987510|NCT01644188|147520097|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.5|||<|0.0001|TWO_SIDED|95.0|-27.2|-19.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.7|-27.2|<0.0001
73987511|NCT01644188|147520098|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.7|||<|0.0001|TWO_SIDED|95.0|-17.7|-11.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-11.7|-17.7|<0.0001
73987512|NCT01644188|147520099|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|95.0|-25.7|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-25.7|<0.0001
73987513|NCT01644188|147520100|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-25.6|-18.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.3|-25.6|<0.0001
73987514|NCT01644188|147520101|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|||<|0.0001|TWO_SIDED|95.0|-17.1|-11.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-11.6|-17.1|<0.0001
73987515|NCT01644188|147520102|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.2|||<|0.0001|TWO_SIDED|95.0|-36.3|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-26.1|-36.3|<0.0001
73987516|NCT01644188|147520103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|95.0|3.7|7.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by Logistic regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.9|3.7|<0.0001
74034923|NCT02065622|147622334|SUPERIORITY||Adjusted risk difference|19.7||||0.003|TWO_SIDED|95.0|6.6|32.7|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||32.7|6.6|0.003
73987517|NCT01644188|147520104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.9|||<|0.0001|TWO_SIDED|95.0|3.9|8.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.8|3.9|<0.0001
73987518|NCT01644188|147520105|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.7|||<|0.0001|TWO_SIDED|95.0|-26.4|-17.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17|-26.4|<0.0001
73987519|NCT01644188|147520106|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1|||<|0.0001|TWO_SIDED|95.0|5.4|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.7|5.4|<0.0001
73987520|NCT01644188|147520107|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.3||||0.9117|TWO_SIDED|95.0|-5.1|4.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.6|-5.1|0.9117
73987521|NCT03119688|147520153|NON_INFERIORITY|The non-Inferiority margin is set at 0.25. The upper limit of the 90% CI is less than this and hence NI is met.|Mean Difference (Net)|-0.077||||0.1769|TWO_SIDED|90.0|-0.1707|0.0169||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis (non-inferiority setting) is that the population mean dryness for Test minus Baxter Sterile Water (negative control) is at least 0.25.||0.0169|-0.1707|0.1769
73987522|NCT03119688|147520153|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.35|||<|0.0001|TWO_SIDED|90.0|0.2565|0.4441||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.4441|0.2565|<.0001
73987523|NCT03119688|147520153|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.427|||<|0.0001|TWO_SIDED|90.0|0.3333|0.5211||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.5211|0.3333|<.0001
73987524|NCT03119688|147520153|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.065||||0.2518|TWO_SIDED|90.0|-0.0287|0.1592||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.1592|-0.0287|0.2518
73987525|NCT02747121|147520169|OTHER|The intervention was external inspections. This is an organizational level intervention and it does not replace any existing intervention.|Odds Ratio (OR)|1.25||||0.24|TWO_SIDED|95.0|0.86|1.8||We used calculated P-values, however only confidence intervals were reported in the published article.|Mixed Models Analysis|||||1.80|0.86|0.24
73987526|NCT03029234|147520171|OTHER|The prespecified threshold that the primary endpoint would be met was if the lower limit of the 95% confidence interval (CI) was greater than 18%.|Overall response rate|35.8|||||TWO_SIDED|95.0|27.3|44.9||||||||44.9|27.3|
73987527|NCT01649297|147520193|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.16|0.13||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%||0.13|-0.16|<0.0001
73987528|NCT01649297|147520193|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.26|0.03||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%||0.03|-0.26|<0.0001
73987529|NCT01649297|147520193|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.79|-0.44|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.44|-0.79|<0.0001
73987530|NCT01649297|147520193|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.68|-0.32|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.32|-0.68|<0.0001
74034924|NCT02065622|147622335|SUPERIORITY||Adjusted risk difference|11.5||||0.093|TWO_SIDED|95.0|-1.9|25.0|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||25.0|-1.9|0.093
74034925|NCT02065622|147622335|SUPERIORITY||Adjusted risk difference|11.1||||0.088|TWO_SIDED|95.0|-1.7|23.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||23.8|-1.7|0.088
74034926|NCT02065622|147622336|SUPERIORITY||Adjusted risk difference|15.9||||0.161|TWO_SIDED|95.0|-6.3|38.2|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||38.2|-6.3|0.161
74089796|NCT03692312|147732505|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline; two-tailed t-test assuming unequal variance.||||0.29
73875429|NCT01623115|147292769|SUPERIORITY_OR_OTHER||LS mean difference|-32.5|||<|0.0001|TWO_SIDED|95.0|-35.7|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.2|-35.7|<0.0001
73875430|NCT01623115|147292770|SUPERIORITY_OR_OTHER||LS mean difference|-56.2|||<|0.0001|TWO_SIDED|95.0|-62.4|-50.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50|-62.4|<0.0001
73875431|NCT01623115|147292771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.0|||<|0.0001|TWO_SIDED|95.0|48.9|498.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||498.1|48.9|<0.0001
73875432|NCT01623115|147292772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.6|||<|0.0001|TWO_SIDED|95.0|49.7|493.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||493.7|49.7|<0.0001
73875433|NCT01623115|147292773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|244.9|||<|0.0001|TWO_SIDED|95.0|34.4|1744.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1744.4|34.4|<0.0001
73875434|NCT01623115|147292774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|240.0|||<|0.0001|TWO_SIDED|95.0|33.9|1700.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1700.7|33.9|<0.0001
73875435|NCT01623115|147292775|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.7|||<|0.0001|TWO_SIDED|95.0|-22.6|-12.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-12.9|-22.6|<0.0001
73987531|NCT01649297|147520193|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.62|-0.27|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.27|-0.62|<0.0001
73987532|NCT01649297|147520193|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.6|-0.25|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.25|-0.60|<0.0001
73987533|NCT01649297|147520194|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.8||||95.0|-9.0|1.8|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening (eGFR)\[MDRD\]value)-fixed effects and baseline HbA1c,baseline FPG-linear covariates||||1.8|-9.0|
73987534|NCT01649297|147520194|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.0|STANDARD_ERROR_OF_MEAN|2.8||||95.0|-10.4|0.5||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening (eGFR)\[MDRD\]value)-fixed effects and baseline HbA1c,baseline FPG-linear covariates||||0.5|-10.4|
73987535|NCT01649297|147520194|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-34.2|-20.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-20.9|-34.2|<0.0001
73987536|NCT01649297|147520194|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-29.2|-15.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-15.9|-29.2|<0.0001
74039574|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0069|TWO_SIDED|95.0|1.11|1.97|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.97|1.11|0.0069
73875436|NCT01623115|147292776|SUPERIORITY_OR_OTHER||LS mean difference|8.0|||<|0.0001|TWO_SIDED|95.0|5.0|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11|5|<0.0001
73875437|NCT01623115|147292777|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-16.0|||<|0.0001|TWO_SIDED|95.0|-21.3|-10.6||Threshold for significance was ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-10.6|-21.3|<0.0001
73875438|NCT01623115|147292778|SUPERIORITY_OR_OTHER||LS mean difference|4.7|||=|0.0002|TWO_SIDED|95.0|2.3|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.2|2.3|= 0.0002
73987537|NCT01649297|147520194|SUPERIORITY_OR_OTHER||Adjusted mean difference|-21.1|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-27.7|-14.4|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-14.4|-27.7|<0.0001
73987538|NCT01649297|147520194|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-24.1|-10.8|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-10.8|-24.1|<0.0001
73987539|NCT01685047|147520195|OTHER|There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Datasets (Device info at Baseline versus 15 minutes prior to the event) were compared using a 2-sided t-test.|||||<|0.05||||||All events with p \<0.05 were visually inspected to confirm they were evaluable; additional criteria for exclusion from further analysis included inappropriate therapy, aberrant conduction, and occurrence of VT/VF within 24h prior to the event.|t-test, 2 sided|||There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Some data was excluded from the primary analysis. All device detections resulting in therapy have been reviewed for appropriateness of the therapy. VT/VF therapy delivered from the device as a result of a non-ventricular arrhythmia or as a result of oversensing by the device has not been included in the primary data analysis.||||<0.05
73987540|NCT02847637|147520206|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.02|0.075||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.075|0.020|<0.0001
73987541|NCT02847637|147520206|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.017|0.066||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.066|0.017|<0.0001
73987542|NCT02847637|147520207|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.028|0.099||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.099|0.028|<0.0001
74034927|NCT02065622|147622336|SUPERIORITY||Adjusted risk difference|10.4||||0.312|TWO_SIDED|95.0|-9.8|30.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||30.6|-9.8|0.312
74034928|NCT02065622|147622337|SUPERIORITY||Adjusted risk difference|12.3||||0.272|TWO_SIDED|95.0|-9.7|34.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||34.4|-9.7|0.272
74034929|NCT02065622|147622337|SUPERIORITY||Adjusted risk difference|5.3||||0.6|TWO_SIDED|95.0|-14.6|25.2|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||25.2|-14.6|0.600
74034930|NCT02065622|147622338|SUPERIORITY||Adjusted risk difference|23.8||||0.074|TWO_SIDED|95.0|-2.3|49.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||49.9|-2.3|0.074
74089797|NCT03692312|147732507|SUPERIORITY|||||||0.077|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline (absolute value); two-tailed t-test assuming unequal variance.||||0.077
73987543|NCT02847637|147520207|SUPERIORITY||ABR Ratio|0.06|||<|0.0001|TWO_SIDED|95.0|0.03|0.103||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.103|0.030|<0.0001
74089798|NCT03692312|147732508|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||Cmax upper quantiles group compared to placebo group for mean Raw Score; two-tailed t-test assuming unequal variance.||||0.071
74089799|NCT02006628|147732517|SUPERIORITY||Treatment difference (GWP42003-placebo)|-2.8||||0.1332|TWO_SIDED|95.0|-6.5|0.9|||ANCOVA|Change from baseline as the response variable, treatment as fixed effect, and individual baseline subscore and age as covariates.||||0.9|-6.5|0.1332
74089800|NCT02006628|147732518|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0896|TWO_SIDED|95.0|0.86|8.0|||Regression, Logistic|Responder (yes/no) is the dependent variable with treatment included as factor and age and baseline P, G, and N scores included as covariates.||||8.00|0.86|0.0896
73875439|NCT01623115|147292779|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-21.5|-13.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13|-21.5|<0.0001
73987544|NCT02847637|147520208|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.019|0.085||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.085|0.019|<0.0001
73987545|NCT02847637|147520208|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.015|0.07||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.070|0.015|<0.0001
73987546|NCT02847637|147520209|SUPERIORITY||ABR Ratio|0.06|||<|0.0001|TWO_SIDED|95.0|0.025|0.151||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.151|0.025|<0.0001
73987547|NCT02847637|147520209|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.006|0.056||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.056|0.006|<0.0001
73987548|NCT02847637|147520210|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.016|0.143||Not controlled for type I error|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.143|0.016|<0.0001
73987549|NCT02847637|147520210|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.018|0.147||Not controlled for type I error|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.147|0.018|<0.0001
73987550|NCT02847637|147520211|SUPERIORITY||ABR Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.195|0.514||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.514|0.195|<0.0001
73987551|NCT02847637|147520212|SUPERIORITY||ABR Ratio|0.37||||0.0002|TWO_SIDED|95.0|0.22|0.626||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.626|0.220|0.0002
73987552|NCT02847637|147520213|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.014|0.067||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.067|0.014|<0.0001
73987553|NCT02847637|147520214|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.023|0.068||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.068|0.023|<0.0001
73987554|NCT02847637|147520215|SUPERIORITY||Mean Difference (Final Values)|12.51||||0.0891|TWO_SIDED|95.0|-1.96|26.98||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||26.98|-1.96|0.0891
73987555|NCT02847637|147520215|SUPERIORITY||Mean Difference (Final Values)|15.97||||0.0349|TWO_SIDED|95.0|1.16|30.78||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||30.78|1.16|0.0349
73987556|NCT02847637|147520216|SUPERIORITY||Mean Difference (Final Values)|5.91||||0.1269|TWO_SIDED|95.0|-1.72|13.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||13.55|-1.72|0.1269
73987557|NCT02847637|147520216|SUPERIORITY||Mean Difference (Final Values)|8.56||||0.0317|TWO_SIDED|95.0|0.77|16.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||16.35|0.77|0.0317
73987558|NCT02847637|147520217|SUPERIORITY||Mean Difference (Final Values)|-4.04||||0.3402|TWO_SIDED|95.0|-12.43|4.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||4.35|-12.43|0.3402
74039575|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2076|TWO_SIDED|95.0|0.91|1.55|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.91|0.2076
73987559|NCT02847637|147520217|SUPERIORITY||Mean Difference (Final Values)|-9.15||||0.0373|TWO_SIDED|95.0|-17.74|-0.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||-0.55|-17.74|0.0373
73987560|NCT02847637|147520218|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.006|TWO_SIDED|95.0|-0.22|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||-0.04|-0.22|0.0060
73987561|NCT02847637|147520218|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.0059|TWO_SIDED|95.0|-0.23|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||-0.04|-0.23|0.0059
73987562|NCT02101268|147520382|SUPERIORITY||Proportion Difference - Stratified CMH|0.01||||0.9|TWO_SIDED|95.0|-0.09|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.09|0.90
73987563|NCT02101268|147520383|SUPERIORITY||Proportion Difference - Stratified CMH|0.2|||<|0.001|TWO_SIDED|95.0|0.09|0.32|||Cochran-Mantel-Haenszel|||||0.32|0.09|< 0.001
73987564|NCT02101268|147520384|SUPERIORITY||Rate ratio|0.8||||0.38|TWO_SIDED|95.0|0.49|1.31|||Negative Binomial Model, Adjusted||A smaller ratio represents larger benefit.|||1.31|0.49|0.38
73987565|NCT02101268|147520385|SUPERIORITY||Proportion Difference - Stratified CMH|0.23||||0.001|TWO_SIDED|95.0|0.09|0.37|||Cochran-Mantel-Haenszel||A larger proportion represents larger benefit.|||0.37|0.09|0.001
73987566|NCT02101268|147520386|SUPERIORITY||Proportion Difference - Stratified CMH|-0.13||||0.1|TWO_SIDED|95.0|-0.29|0.03|||Cochran-Mantel-Haenszel||A smaller proportion represents larger benefit.|||0.03|-0.29|0.10
73987567|NCT00740870|147520387|SUPERIORITY||Kaplan-Meier Rate|74.2|||<|0.0001|ONE_SIDED|95.0|67.1||||Z test||||||67.1|<0.0001
74034931|NCT02065622|147622338|SUPERIORITY||Adjusted risk difference|15.0||||0.21|TWO_SIDED|95.0|-8.5|38.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||38.4|-8.5|0.210
74034932|NCT02065622|147622339|SUPERIORITY||Adjusted risk difference|20.0||||0.151|TWO_SIDED|95.0|-7.3|47.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||47.3|-7.3|0.151
74034933|NCT02065622|147622339|SUPERIORITY||Adjusted risk difference|12.8||||0.299|TWO_SIDED|95.0|-11.3|36.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||36.8|-11.3|0.299
74034934|NCT02065622|147622340|SUPERIORITY||Adjusted risk difference|4.5||||0.422|TWO_SIDED|95.0|-6.4|15.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||15.3|-6.4|0.422
74034935|NCT02065622|147622340|SUPERIORITY||Adjusted risk difference|3.4||||0.513|TWO_SIDED|95.0|-6.8|13.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||13.6|-6.8|0.513
74034936|NCT02065622|147622341|SUPERIORITY||Adjusted risk difference|3.7||||0.351|TWO_SIDED|95.0|-4.1|11.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||11.4|-4.1|0.351
74034937|NCT02065622|147622341|SUPERIORITY||Adjusted risk difference|3.9||||0.292|TWO_SIDED|95.0|-3.3|11.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||11.1|-3.3|0.292
74089801|NCT02006628|147732519|SUPERIORITY||Treatment difference (GWP42003-placebo)|-1.4||||0.0188|TWO_SIDED|95.0|-2.5|-0.2|||ANCOVA|||||-0.2|-2.5|0.0188
74034938|NCT02065622|147622342|SUPERIORITY||Adjusted risk difference|5.4||||0.121|TWO_SIDED|95.0|-1.4|12.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||12.1|-1.4|0.121
74089802|NCT02006628|147732520|SUPERIORITY||Treatment difference (GWP42003-placebo)|0.0||||0.9647|TWO_SIDED|95.0|-1.3|1.4|||ANCOVA|||||1.4|-1.3|0.9647
74089803|NCT02006628|147732521|SUPERIORITY||Treatment difference (GWP42003-placebo)|-1.3||||0.1963|TWO_SIDED|95.0|-3.2|0.7|||ANCOVA|||||0.7|-3.2|0.1963
74089804|NCT02006628|147732522|SUPERIORITY||Treatment difference (GWP42003-placebo)|-3.5||||0.1167|TWO_SIDED|95.0|-7.9|0.9|||ANCOVA|||||0.9|-7.9|0.1167
74089805|NCT02006628|147732523|SUPERIORITY||Treatment difference (GWP42003-placebo)|-0.3||||0.0443|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||||0.0|-0.5|0.0443
74089806|NCT02006628|147732524|SUPERIORITY||Treatment difference (GWP42003-placebo)|-0.5||||0.0182|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.0182
73987568|NCT00839332|147520418|SUPERIORITY_OR_OTHER||Bayesian Posterior Probability|0.333|||||TWO_SIDED||||||||Inference about survival was made using a Bayesian posterior probability. The combination treatment would have been considered superior to gemcitabine alone if the posterior probability of superiority exceeded 0.8.|||||
73987569|NCT02864342|147520472|OTHER||||||<|0.001|||||||Satterthwaite t-test|||The effect of medication reminders on Symbicort adherence was evaluated using a t-test. The equality of variances was also tested and as the variances were not equal, the Satterthwaite-t test was reported.||||<0.001
73987570|NCT00776984|147520478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.091|0.217||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.217|0.091|<0.0001
73987571|NCT00776984|147520479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.03||0.0002||95.0|0.053|0.169||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.169|0.053|0.0002
73875440|NCT01623115|147292780|SUPERIORITY_OR_OTHER||LS mean difference|4.3||||0.0031|TWO_SIDED|95.0|1.5|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.2|1.5|0.0031
73875441|NCT01623115|147292781|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.7||||0.0003|TWO_SIDED|95.0|-15.0|-4.4||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.4|-15|0.0003
73875442|NCT01623115|147292782|SUPERIORITY_OR_OTHER||LS mean difference|2.8||||0.0187|TWO_SIDED|95.0|0.5|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.2|0.5|0.0187
73875443|NCT00430716|147292806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|24.15||||0.011|ONE_SIDED|97.5|3.37||||ANOVA|||An analysis of variance (ANOVA) model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% lower confidence limit for the difference was presented.|||3.37|0.011
73987572|NCT00776984|147520480|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||||0.0343
73987573|NCT00776984|147520481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0275||95.0|0.01|0.177||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.177|0.010|0.0275
73987574|NCT00776984|147520482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.041||0.0099||95.0|0.025|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.186|0.025|0.0099
73987575|NCT00776984|147520483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.084|0.202||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.202|0.084|<0.0001
73987576|NCT00776984|147520484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.04||0.0063||95.0|0.031|0.187||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.187|0.031|0.0063
73875444|NCT00430716|147292806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.17||||0.545|ONE_SIDED|97.5|-21.48||||ANOVA|||ANOVA model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% lower confidence limit for the difference was presented.|||-21.48|0.545
73875445|NCT00430716|147292807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.51||||0.278|TWO_SIDED|95.0|-7.07|2.05|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used Analysis of Covariance (ANCOVA), with etiology and baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||2.05|-7.07|0.278
73875446|NCT00430716|147292807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44||||0.846|TWO_SIDED|95.0|-4.98|4.09|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used ANCOVA, with etiology and baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||4.09|-4.98|0.846
73875447|NCT00430716|147292809|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.448|TWO_SIDED|95.0|0.5|4.78|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.||4.78|0.50|0.448
73987577|NCT00776984|147520485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.087|0.217||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.217|0.087|<0.0001
73987578|NCT00776984|147520486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.03||0.0026||95.0|0.032|0.151||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.151|0.032|0.0026
73987579|NCT00776984|147520487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.078|0.199||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.199|0.078|<0.0001
74034939|NCT02065622|147622342|SUPERIORITY||Adjusted risk difference|6.5||||0.046|TWO_SIDED|95.0|0.1|12.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||12.8|0.1|0.046
74034940|NCT02065622|147622343|SUPERIORITY||Adjusted risk difference|7.5||||0.159|TWO_SIDED|95.0|-2.9|17.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||17.9|-2.9|0.159
74034941|NCT02065622|147622343|SUPERIORITY||Adjusted risk difference|8.0||||0.109|TWO_SIDED|95.0|-1.8|17.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||17.9|-1.8|0.109
74034942|NCT02065622|147622344|SUPERIORITY||Adjusted risk difference|1.4||||0.903|TWO_SIDED|95.0|-21.0|23.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||23.8|-21.0|0.903
74034943|NCT02065622|147622344|SUPERIORITY||Adjusted risk difference|1.3||||0.901|TWO_SIDED|95.0|-18.8|21.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||21.3|-18.8|0.901
74034944|NCT02065622|147622345|SUPERIORITY||Adjusted risk difference|7.7||||0.16|TWO_SIDED|95.0|-3.0|18.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||18.4|-3.0|0.160
74034945|NCT02065622|147622345|SUPERIORITY||Adjusted risk difference|9.1||||0.076|TWO_SIDED|95.0|-0.9|19.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||19.1|-0.9|0.076
74034946|NCT02065622|147622346|SUPERIORITY||Adjusted risk difference|7.3||||0.207|TWO_SIDED|95.0|-4.0|18.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||18.6|-4.0|0.207
74034947|NCT02065622|147622346|SUPERIORITY||Adjusted risk difference|4.2||||0.44|TWO_SIDED|95.0|-6.4|14.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||14.8|-6.4|0.440
74034948|NCT04973228|147622361|SUPERIORITY||Odds Ratio (OR)|2.79|||<|0.0001|TWO_SIDED|95.0|1.75|4.45|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 8||4.45|1.75|<0.0001
74034949|NCT04973228|147622362|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0001|TWO_SIDED|95.0|1.68|5.19|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 8||5.19|1.68|0.0001
74034950|NCT04973228|147622363|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0007|TWO_SIDED|95.0|1.47|4.67|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 4||4.67|1.47|0.0007
74034951|NCT04973228|147622364|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0016|TWO_SIDED|95.0|1.41|5.34|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 2||5.34|1.41|0.0016
74034952|NCT04973228|147622365|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0002|TWO_SIDED|95.0|1.54|3.84|||Cochran-Mantel-Haenszel|Pooled by site and IGA strata with multiple imputation to handle missing data|Pooled by site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 2||3.84|1.54|0.0002
74034953|NCT04973228|147622366|SUPERIORITY||Odds Ratio (OR)|3.22|||<|0.0001|TWO_SIDED|95.0|2.06|5.03|||Cochran-Mantel-Haenszel|Pooled by site and IGA strata with multiple imputation to handle missing data|Pooled by site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 4||5.03|2.06|<0.0001
74034954|NCT04973228|147622367|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.56|3.73|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Scaling Score of 0 at Week 8||3.73|1.56|<0.0001
74034955|NCT04973228|147622368|SUPERIORITY||Odds Ratio (OR)|3.22|||<|0.0001|TWO_SIDED|95.0|2.05|5.06|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Erythema Score of 0 at Week 8||5.06|2.05|<0.0001
74034956|NCT04237207|147622369|NON_INFERIORITY|The primary efficacy objective is to demonstrate non-inferiority of AutoSense on the M90 processor compared to AutoSound on the Q90 processor for the AzBio sentence test in quiet mode based on a paired t-test. The primary efficacy analyses will test the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quiet mode (AutoSense on M90 - AutoSound on Q90) are less than or equal to -10 percentage points.||||||0.001|||||||t-test, 2 sided|||||||0.0010
74034957|NCT04237207|147622370|NON_INFERIORITY|The 1st secondary endpoint was to demonstrate that speech recognition in noise with AutoSense on a 301-M062 processor was no worse than speech recognition in noise with currently approved software on a Q90 processor.||||||0.001|||||||t-test, 2 sided|||||||0.0010
74089807|NCT02006628|147732525|SUPERIORITY||Treatment difference (GWP42003-placebo)|1.31||||0.0677|TWO_SIDED|95.0|-0.1|2.72|||ANCOVA|||||2.72|-0.10|0.0677
74089808|NCT00262041|147732526|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup A compared with that of MenACWY PS vaccine.||||<0.001
73875448|NCT00430716|147292809|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.897|TWO_SIDED|95.0|0.35|3.32|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.||3.32|0.35|0.897
74034958|NCT04237207|147622371|NON_INFERIORITY|"The 2nd secondary endpoint was to demonstrate increased speech recognition in noise with the 301-M062 sound processor when comparing Omnidirectional program to AutoSense."|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73987580|NCT00776984|147520488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.044||0.0088||95.0|0.029|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.200|0.029|0.0088
74034959|NCT00406640|147622375|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.67||||0.243||95.0|-0.46|1.81|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared with ESC||1.81|-0.46|0.243
73875449|NCT00430716|147292810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-104.8||||0.005|TWO_SIDED|95.0|-177.44|-32.16|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||-32.16|-177.44|0.005
73987581|NCT00776984|147520489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.042||0.0933||95.0|-0.012|0.153||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.153|-0.012|0.0933
73987582|NCT00776984|147520490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.041||0.0074||95.0|0.029|0.189||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.189|0.029|0.0074
73987583|NCT00776984|147520491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.654|STANDARD_ERROR_OF_MEAN|4.807|<|0.0001||95.0|11.199|30.108||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||30.108|11.199|<0.0001
73987584|NCT00776984|147520492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.453|STANDARD_ERROR_OF_MEAN|5.044|<|0.0001||95.0|22.532|42.374||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||42.374|22.532|<0.0001
73987585|NCT00776984|147520493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0027||95.0|0.031|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.031|0.0027
74034960|NCT00406640|147622376|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.608||||0.077||95.0|0.4|0.92|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||0.92|0.40|0.077
74034961|NCT00406640|147622377|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.571||||0.0054||95.0|0.39|0.85|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odds ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||0.85|0.39|0.0054
74089809|NCT00262041|147732526|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup A compared with that of MenACWY PS vaccine.||||<0.001
73987586|NCT00776984|147520494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.074|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.200|0.074|<0.0001
73987587|NCT00776984|147520495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.197|STANDARD_ERROR_OF_MEAN|0.741||0.1073||95.0|-0.261|2.655||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||2.655|-0.261|0.1073
73987588|NCT00776984|147520496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.4788||95.0|0.65|1.23||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||1.23|0.65|0.4788
73987589|NCT00776984|147520497|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8|STANDARD_ERROR_OF_MEAN|0.11||0.1007||95.0|0.61|1.04||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.04|0.61|0.1007
73987590|NCT00776984|147520498|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|STANDARD_ERROR_OF_MEAN|0.15||0.7906||95.0|0.71|1.3||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.30|0.71|0.7906
74089810|NCT00262041|147732526|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup C compared with that of MenACWY PS vaccine.||||<0.001
74089811|NCT00262041|147732526|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.||||||0.003||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup C compared with that of MenACWY PS vaccine.||||0.003
73987591|NCT00776984|147520499|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57||||0.004||95.0|0.38|0.84||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||0.84|0.38|0.0040
73987592|NCT00776984|147520500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.5481||95.0|0.58|1.32||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||1.32|0.58|0.5481
73987593|NCT00776984|147520501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.7188||95.0|0.33|2.14||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||2.14|0.33|0.7188
73987594|NCT00776984|147520502|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95|STANDARD_ERROR_OF_MEAN|0.23||0.8503||95.0|0.59|1.54||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo.|||1.54|0.59|0.8503
73987595|NCT00776984|147520503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.8129||95.0|0.29|2.46||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||2.46|0.29|0.8129
73987596|NCT00776984|147520504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.078||0.0225||95.0|0.025|0.331||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.331|0.025|0.0225
73987597|NCT00776984|147520505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.0803||95.0|-0.017|0.296||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.296|-0.017|0.0803
73987598|NCT00776984|147520506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.199|STANDARD_ERROR_OF_MEAN|0.067||0.003||95.0|-0.33|-0.068||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||-0.068|-0.330|0.0030
73987599|NCT00776984|147520507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.069||0.0533||95.0|-0.267|0.002||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.002|-0.267|0.0533
73987600|NCT00776984|147520508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.028||0.6632||95.0|-0.043|0.067||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.067|-0.043|0.6632
73987601|NCT00776984|147520509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|STANDARD_ERROR_OF_MEAN|0.189||0.1664||95.0|-0.635|0.11||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.110|-0.635|0.1664
73987602|NCT00776984|147520510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0427|TWO_SIDED|95.0|1.01|1.73||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks||1.73|1.01|0.0427
73987603|NCT00776984|147520510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0001|TWO_SIDED|95.0|1.28|2.21||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks||2.21|1.28|0.0001
73987604|NCT02573883|147520522|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
73987605|NCT02573883|147520523|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
73987606|NCT02573883|147520525|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
73987607|NCT02573883|147520527|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
73987608|NCT00118703|147520554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094||||0.604|TWO_SIDED|95.0|-0.26|0.45|||ANCOVA|The analysis method was adjusted for Baseline rTNSS, country, age, and gender, in addition to treatment effect.||||0.45|-0.26|0.604
73987609|NCT00118703|147520555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061||||0.729|TWO_SIDED|95.0|-0.29|0.41|||ANCOVA|The analysis method was adjusted for Baseline iTNSS, country, age, and gender, in addition to treatment effect.||||0.41|-0.29|0.729
73987610|NCT00118703|147520556|SUPERIORITY_OR_OTHER|||||||0.064|||||||Regression, Logistic|Overall evaluation of response to therapy was illustrated and analyzed using logistic regression adjusting for age, gender, investigator, and treatmen||||||0.064
73987611|NCT02725008|147520571|SUPERIORITY||Odds Ratio (OR)|2.32||||0.3|TWO_SIDED|95.0|0.54|10.07|||Chi-squared|||||10.07|0.54|0.3
73987612|NCT02725008|147520572|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
73987613|NCT01180790|147520600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||||||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg, 400 mg, and 800 mg ACH-0141625.|exact Cochran-Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||The null hypothesis is no difference between proportions of participants in each treatment group achieving RVR4 at Week 4 of the study, while the alternative hypothesis is that the proportion of participants achieving RVR4 at Week 4 increases with increasing doses of ACH-0141625.||||0.003
73987614|NCT01180790|147520600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
73987615|NCT01180790|147520600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
73987616|NCT01180790|147520600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
73875450|NCT00430716|147292810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-25.0||||0.496|TWO_SIDED|95.0|-97.5|47.5|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||47.50|-97.50|0.496
73875451|NCT00430716|147292811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-462.12||||0.009|TWO_SIDED|95.0|-807.53|-116.71|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||-116.71|-807.53|0.009
73987617|NCT01180790|147520602|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34||||||To control for multiplicity, the proportion of participants in each treatment group achieving cEVR is analyzed using a Cochran-Armitage test for trend among the ordered treatment groups: 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625.|Exact Cochran-Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||The null hypothesis is no difference between proportions of participants in each treatment group achieving cEVR at Week 12 of the study, while the alternative hypothesis is that the proportion of participants achieving cEVR at Week 12 increases with increasing doses of ACH-0141625.||||0.34
73987618|NCT01568112|147520614|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||12.9|-30.8|
73987619|NCT01568112|147520614|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||27.8|-14.1|
73987620|NCT01568112|147520614|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events||12.9|-30.8|
73987621|NCT01568112|147520614|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events||25.5|-16.4|
73987622|NCT01568112|147520614|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events||1.3|-41.7|
73987623|NCT01568112|147520614|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events||18.7|-23.3|
73987624|NCT01568112|147520614|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events||8.3|-35.2|
73987625|NCT01568112|147520614|SUPERIORITY_OR_OTHER||Difference in percentage|12.0|||||TWO_SIDED|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events||32.2|-9.5|
73987626|NCT01568112|147520614|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events||12.9|-30.8|
73987627|NCT01568112|147520614|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events||25.5|-16.4|
73987628|NCT01568112|147520615|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||8.3|-35.2|
73987629|NCT01568112|147520615|SUPERIORITY_OR_OTHER||Difference in percentage|12.0|||||TWO_SIDED|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||32.2|-9.5|
73987630|NCT01568112|147520615|SUPERIORITY_OR_OTHER||Difference in percentage|-19.0|||||TWO_SIDED|95.0|-39.6|3.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||3.7|-39.6|
73987631|NCT01568112|147520615|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||27.8|-14.1|
73987632|NCT01568112|147520615|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||1.3|-41.7|
73987633|NCT01568112|147520615|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||27.8|-14.1|
73987634|NCT01568112|147520615|SUPERIORITY_OR_OTHER||Difference in percentage|-33.0|||||TWO_SIDED|95.0|-52.2|-10.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-10.6|-52.2|
73987635|NCT01568112|147520615|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-21.0|21.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||21.0|-21.0|
73987636|NCT01568112|147520615|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||1.3|-41.7|
73987637|NCT01568112|147520615|SUPERIORITY_OR_OTHER||Difference in percentage|18.0|||||TWO_SIDED|95.0|-2.4|38.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||38.8|-2.4|
73987638|NCT01568112|147520616|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||9.2|-35.6|
73987639|NCT01568112|147520616|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||21.7|-24.7|
73987640|NCT01568112|147520616|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||9.2|-35.6|
73987641|NCT01568112|147520616|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-22.9|23.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||23.7|-22.9|
73987642|NCT01568112|147520616|SUPERIORITY_OR_OTHER||Difference in percentage|-11.0|||||TWO_SIDED|95.0|-33.0|11.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||11.9|-33.0|
74034962|NCT00406640|147622378|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.26||95.0|-0.09|0.33|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean|DVS SR compared with ESC||0.33|-0.09|0.260
74034963|NCT00406640|147622379|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14||||0.239||95.0|-0.09|0.37|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean|||0.37|-0.09|0.239
74034964|NCT00406640|147622380|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.37||||0.516||95.0|-0.75|1.49|||Mixed Models Analysis|Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared to ESC||1.49|-0.75|0.516
73987643|NCT01568112|147520616|SUPERIORITY_OR_OTHER||Difference in percentage|-5.0|||||TWO_SIDED|95.0|-27.5|18.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||18.8|-27.5|
73987644|NCT01568112|147520616|SUPERIORITY_OR_OTHER||Difference in percentage|-17.0|||||TWO_SIDED|95.0|-38.1|6.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||6.5|-38.1|
73987645|NCT01568112|147520616|SUPERIORITY_OR_OTHER||Difference in percentage|-11.0|||||TWO_SIDED|95.0|-34.2|12.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||12.2|-34.2|
73987646|NCT01568112|147520616|SUPERIORITY_OR_OTHER||Difference in percentage|-20.0|||||TWO_SIDED|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||3.8|-40.6|
73875452|NCT00430716|147292811|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-141.45||||0.414|TWO_SIDED|95.0|-483.48|200.58|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||200.58|-483.48|0.414
73987647|NCT01568112|147520616|SUPERIORITY_OR_OTHER||Difference in percentage|-18.0|||||TWO_SIDED|95.0|-40.2|5.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||5.5|-40.2|
74034965|NCT00406640|147622381|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.01||||0.635||95.0|-0.03|0.06|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) with treatment, time and site as factors and baseline as covariant.|DVS SR adjusted mean change minus ESC adjusted mean change|DVS SR compared to ESC||0.06|-0.03|0.635
74034966|NCT00406640|147622382|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.702||95.0|0.63|2.0|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||2.00|0.63|0.702
74034967|NCT00406640|147622383|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34||||0.234||95.0|0.83|2.16|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||2.16|0.83|0.234
74034968|NCT00406640|147622387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.927||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: end of therapy||||0.927
74034969|NCT00406640|147622387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after 1 week of taper||||0.055
74034970|NCT00406640|147622387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after 2 weeks of taper||||0.025
73987648|NCT01568112|147520617|SUPERIORITY_OR_OTHER||Mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-3.0|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||-0.9|-3.0|
73987649|NCT01568112|147520617|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|0.2|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||2.3|0.2|
73987650|NCT01568112|147520617|SUPERIORITY_OR_OTHER||Mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-3.2|-1.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||-1.2|-3.2|
73987651|NCT01568112|147520617|SUPERIORITY_OR_OTHER||Mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|0.1|2.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||2.5|0.1|
73987652|NCT01568112|147520617|SUPERIORITY_OR_OTHER||Mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-2.8|-0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||-0.7|-2.8|
73987653|NCT01568112|147520617|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|0.1|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||2.3|0.1|
73987654|NCT01568112|147520617|SUPERIORITY_OR_OTHER||Mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.7|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-0.9|-2.7|
73987655|NCT01568112|147520617|SUPERIORITY_OR_OTHER||Mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-0.4|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||1.6|-0.4|
74034971|NCT00406640|147622387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.653||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after \> 2 weeks of taper||||0.653
74034972|NCT00755846|147622409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.135||0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.001
74039576|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0072|TWO_SIDED|95.0|1.1|1.86|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.86|1.10|0.0072
73875453|NCT00430716|147292812|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.89|TWO_SIDED|95.0|-0.17|0.15|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||0.15|-0.17|0.890
73875454|NCT00430716|147292812|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.13||||0.124|TWO_SIDED|95.0|-0.29|0.04|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||0.04|-0.29|0.124
73987656|NCT01568112|147520617|SUPERIORITY_OR_OTHER||Mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.8|-1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||-1.0|-2.8|
73987657|NCT01568112|147520617|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|0.2|2.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||2.2|0.2|
73987658|NCT01568112|147520618|SUPERIORITY_OR_OTHER||Mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||0.8|-1.7|
73987659|NCT01568112|147520618|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.8|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||0.4|-1.8|
73987660|NCT01568112|147520618|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||0.6|-2.0|
73987661|NCT01568112|147520618|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.9|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||0.5|-1.9|
73987662|NCT01568112|147520618|SUPERIORITY_OR_OTHER||Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-2.0|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||0.4|-2.0|
73875455|NCT00430716|147292813|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|0.0||||0.382|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.||0.00|-1.00|0.382
73987663|NCT01568112|147520618|SUPERIORITY_OR_OTHER||Mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.1|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||0.2|-2.1|
73987664|NCT01568112|147520618|SUPERIORITY_OR_OTHER||Mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-2.2|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||0.1|-2.2|
74039577|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0694|TWO_SIDED|95.0|0.97|2.22|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.22|0.97|0.0694
73987665|NCT01568112|147520618|SUPERIORITY_OR_OTHER||Mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.2|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-0.0|-2.2|
74039578|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.53|3.36|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.36|1.53|<.0001
74039579|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.36||||0.121|TWO_SIDED|95.0|0.92|2.0|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.92|0.1210
73987666|NCT01568112|147520618|SUPERIORITY_OR_OTHER||Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.1|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||0.4|-2.1|
73987667|NCT01568112|147520618|SUPERIORITY_OR_OTHER||Mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.4|-0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||-0.1|-2.4|
73987668|NCT01568112|147520619|SUPERIORITY_OR_OTHER||Difference in percentage|-12.0|||||TWO_SIDED|95.0|-32.2|9.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||9.5|-32.2|
73987669|NCT01568112|147520619|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||27.8|-14.1|
73987670|NCT01568112|147520620|SUPERIORITY_OR_OTHER||Difference in percentage|-22.0|||||TWO_SIDED|95.0|-41.0|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||0.1|-41.0|
73987671|NCT01568112|147520620|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||27.8|-14.1|
73987672|NCT01568112|147520621|SUPERIORITY_OR_OTHER||Difference in percentage|-20.0|||||TWO_SIDED|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||3.8|-40.6|
73987673|NCT01568112|147520621|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||21.7|-24.7|
73987674|NCT01568112|147520622|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-22.0|22.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||22.0|-22.0|
73987675|NCT01568112|147520622|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||25.5|-16.4|
73987676|NCT01568112|147520623|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.2|19.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||19.7|-24.2|
73987677|NCT01568112|147520623|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||18.7|-23.3|
73875456|NCT00430716|147292813|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.141|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.||1.00|0.00|0.141
73987678|NCT01568112|147520624|SUPERIORITY_OR_OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-29.4|17.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||17.1|-29.4|
73987679|NCT01568112|147520624|SUPERIORITY_OR_OTHER||Difference in percentage|1.0|||||TWO_SIDED|95.0|-22.1|24.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||24.5|-22.1|
73987680|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.1|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||1.1|-1.1|
73987681|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.1|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.9|-1.1|
73987682|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.4|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.8|-1.4|
73987683|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.7|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.1|-1.7|
73987684|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-0.5|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||1.6|-0.5|
73987685|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||1.3|-0.7|
73987686|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-1.0|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.9|-1.0|
73987687|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.1|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.8|-1.1|
73987688|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.7|-0.6|
74089812|NCT00262041|147732526|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup W compared with that of MenACWY PS vaccine.||||<0.001
73987689|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.6|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.5|-0.6|
73987690|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.0|0.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.3|-1.0|
73987691|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.8|-0.8|
73987692|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.6|-1.0|
73987693|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.9|-0.8|
73987694|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Difference in percentage|0.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.7|1.1||||||Bloating||1.1|-0.7|
73987695|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.9|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.7|-0.9|
73987696|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||0.9|-0.8|
73987697|NCT01568112|147520625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-0.7|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||1.1|-0.7|
73987698|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.0|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.8|-1.0|
73987699|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.8|-0.8|
73987700|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.7|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.4|-1.7|
73987701|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.7|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.2|-1.7|
73987702|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.7|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||0.6|-0.7|
73987703|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||0.8|-0.7|
73987704|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.7|-0.6|
73987705|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.2|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||1.3|-0.2|
73987706|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.4|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.4|-0.4|
73987707|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.4|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.2|-0.4|
73987708|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.6|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.6|-0.6|
73987709|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.7|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.5|-0.7|
73987710|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.1|1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||1.0|-0.1|
73987711|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.2|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.6|-0.2|
73987712|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.8|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.7|-0.8|
73987713|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.8|-0.7|
73987714|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-1.6|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||-0.0|-1.6|
73987715|NCT01568112|147520626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.2|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||0.5|-1.2|
73987716|NCT01568112|147520627|SUPERIORITY_OR_OTHER||Difference in percentage|9.0|||||TWO_SIDED|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||30.0|-11.8|
73987717|NCT01568112|147520627|SUPERIORITY_OR_OTHER||Difference in percentage|9.0|||||TWO_SIDED|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||30.0|-11.8|
73987718|NCT01568112|147520628|SUPERIORITY_OR_OTHER||Difference in percentage|2.0|||||TWO_SIDED|95.0|-18.8|23.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||23.3|-18.8|
73987719|NCT01568112|147520628|SUPERIORITY_OR_OTHER||Difference in percentage|6.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||27.8|-14.1|
73987720|NCT01568112|147520629|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-32.1|14.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||14.3|-32.1|
73987721|NCT01568112|147520629|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-25.0|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||21.7|-25.0|
73987722|NCT01568112|147520636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|13.79|||TWO_SIDED|95.0|-20.9|34.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||34.1|-20.9|
73987723|NCT01568112|147520636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|10.03|||TWO_SIDED|95.0|-14.2|25.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||25.7|-14.2|
73987724|NCT01568112|147520637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.2|STANDARD_ERROR_OF_MEAN|24.4|||TWO_SIDED|95.0|-26.5|70.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||70.9|-26.5|
73987725|NCT01568112|147520637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|11.08|||TWO_SIDED|95.0|-20.5|23.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||23.6|-20.5|
73987726|NCT01568112|147520638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.5|STANDARD_ERROR_OF_MEAN|13.32|||TWO_SIDED|95.0|-9.2|44.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||44.2|-9.2|
73987727|NCT01568112|147520638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|8.8|||TWO_SIDED|95.0|-17.2|18.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||18.0|-17.2|
73987728|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.96|STANDARD_ERROR_OF_MEAN|4.601|||TWO_SIDED|95.0|-6.34|12.26|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||12.26|-6.34|
73987729|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|STANDARD_ERROR_OF_MEAN|2.347|||TWO_SIDED|95.0|-8.81|0.67|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.67|-8.81|
73987730|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.74|STANDARD_ERROR_OF_MEAN|7.335|||TWO_SIDED|95.0|-3.15|26.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||26.63|-3.15|
73987731|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|STANDARD_ERROR_OF_MEAN|2.321|||TWO_SIDED|95.0|-2.67|6.77|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||6.77|-2.67|
73987732|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.21|STANDARD_ERROR_OF_MEAN|7.812|||TWO_SIDED|95.0|-6.72|25.14|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||25.14|-6.72|
73987733|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|4.152|||TWO_SIDED|95.0|-11.31|5.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||5.63|-11.31|
73987734|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|7.516|||TWO_SIDED|95.0|-18.36|12.19|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||12.19|-18.36|
73987735|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|7.141|||TWO_SIDED|95.0|-20.71|8.35|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||8.35|-20.71|
73987736|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.21|STANDARD_ERROR_OF_MEAN|5.292|||TWO_SIDED|95.0|-22.9|6.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||6.49|-22.90|
73987737|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.33|STANDARD_ERROR_OF_MEAN|6.536|||TWO_SIDED|95.0|-30.13|11.47|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||11.47|-30.13|
73987738|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.69|STANDARD_ERROR_OF_MEAN|8.376|||TWO_SIDED|95.0|-30.02|4.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||4.63|-30.02|
73987739|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|STANDARD_ERROR_OF_MEAN|8.654|||TWO_SIDED|95.0|-29.48|6.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||6.32|-29.48|
73987740|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|STANDARD_ERROR_OF_MEAN|10.274|||TWO_SIDED|95.0|-35.44|7.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||7.57|-35.44|
73987741|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.29|STANDARD_ERROR_OF_MEAN|12.369|||TWO_SIDED|95.0|-33.39|18.81|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||18.81|-33.39|
73987742|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|6.472|||TWO_SIDED|95.0|-20.4|5.93|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||5.93|-20.40|
74034973|NCT00755846|147622409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.171||0.004||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.004
74039580|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6706|TWO_SIDED|95.0|0.76|1.54|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.54|0.76|0.6706
73987743|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|60.33|STANDARD_ERROR_OF_MEAN|34.455|||TWO_SIDED|95.0|-10.78|131.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||131.4|-10.78|
73987744|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|59.87|STANDARD_ERROR_OF_MEAN|65.007|||TWO_SIDED|95.0|-71.51|191.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||191.2|-71.51|
73987745|NCT01568112|147520639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.78|STANDARD_ERROR_OF_MEAN|40.44|||TWO_SIDED|95.0|-27.09|136.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||136.6|-27.09|
73987746|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|5.281|||TWO_SIDED|95.0|-6.79|14.68|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||14.68|-6.79|
73987747|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|2.563|||TWO_SIDED|95.0|-9.57|0.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.83|-9.57|
73987748|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.51|STANDARD_ERROR_OF_MEAN|8.024|||TWO_SIDED|95.0|-2.84|29.86|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||29.86|-2.84|
73987749|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|STANDARD_ERROR_OF_MEAN|2.379|||TWO_SIDED|95.0|-2.41|7.29|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||7.29|-2.41|
73987750|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.84|STANDARD_ERROR_OF_MEAN|8.143|||TWO_SIDED|95.0|-5.81|27.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||27.50|-5.81|
73987751|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|4.671|||TWO_SIDED|95.0|-12.08|7.09|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||7.09|-12.08|
73987752|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|8.488|||TWO_SIDED|95.0|-19.03|15.64|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||15.64|-19.03|
73987753|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|STANDARD_ERROR_OF_MEAN|7.832|||TWO_SIDED|95.0|-23.93|8.11|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||8.11|-23.93|
73987754|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|4.811|||TWO_SIDED|95.0|-23.8|17.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||17.60|-23.80|
73987755|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|4.155|||TWO_SIDED|95.0|-22.75|13.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||13.00|-22.75|
73987756|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.08|STANDARD_ERROR_OF_MEAN|16.243|||TWO_SIDED|95.0|-59.2|9.05|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||9.05|-59.20|
73987757|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.95|STANDARD_ERROR_OF_MEAN|14.83|||TWO_SIDED|95.0|-54.89|6.98|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||6.98|-54.89|
73875457|NCT01329978|147292819|SUPERIORITY_OR_OTHER||Difference in proportions|-1.4||||0.77|TWO_SIDED|95.0|-12.2|9.4||The p-value is based on the Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||The difference in proportions and its 95% confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel (MH) proportions.|The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL). Only participants with genotype 1 were included in the comparison due to the fact that participants with genotype 4 and 6 were only enrolled in the SOF+PEG+RBV 24 weeks group.||9.4|-12.2|0.77
73875458|NCT01329978|147292819|SUPERIORITY_OR_OTHER||Difference in proportions|-0.4||||0.93|TWO_SIDED|95.0|-10.8|9.9||The p-value is based on the CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel|The difference in proportions and its 95% CI were calculated based on stratum-adjusted MH proportions.||The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL).||9.9|-10.8|0.93
73875459|NCT03324802|147292841|SUPERIORITY|||||||1|||||||Log Rank|||||||1.0
73875460|NCT03324802|147292842|SUPERIORITY|||||||1|||||||Log Rank|||||||1.0
73875461|NCT03324802|147292844|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.320
73875462|NCT03324802|147292845|SUPERIORITY|||||||0.163|||||||Chi-squared|||||||0.163
73987758|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.49|STANDARD_ERROR_OF_MEAN|10.847|||TWO_SIDED|95.0|-35.38|10.39|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||10.39|-35.38|
73875463|NCT03324802|147292846|SUPERIORITY|||||||0.97|||||||Log Rank|||||||0.97
73875464|NCT03324802|147292847|SUPERIORITY|||||||0.5|||||||Gray Test P-value|||||||0.5
73875465|NCT03324802|147292848|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
73875466|NCT01236521|147292875|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|0.13||0.0385|TWO_SIDED||||||Mixed Models Analysis|||||||0.0385
73875467|NCT01236521|147292876|SUPERIORITY||Mean Difference (Net)|0.44|STANDARD_DEVIATION|0.11||0.0067|TWO_SIDED||||||Mixed Models Analysis|||||||0.0067
74039581|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.67||||0.0022|TWO_SIDED|95.0|1.2|2.32|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.32|1.20|0.0022
73875468|NCT01236521|147292877|SUPERIORITY||Median Difference (Net)|0.39|STANDARD_DEVIATION|0.15||0.074|TWO_SIDED||||||Mixed Models Analysis|||||||0.0740
73875469|NCT03890588|147292887|SUPERIORITY||Risk Ratio (RR)|1.17|STANDARD_ERROR_OF_MEAN|0.12||0.21|TWO_SIDED|95.0|0.91|1.51|||Mixed Models Analysis|||||1.51|.91|.21
73875470|NCT03890588|147292888|SUPERIORITY||Risk Ratio (RR)|0.95|STANDARD_ERROR_OF_MEAN|0.11||0.61|TWO_SIDED|95.0|0.76|1.18|||Mixed Models Analysis|||||1.18|.76|.61
73875471|NCT03890588|147292889|SUPERIORITY||Risk Ratio (RR)|0.98|STANDARD_ERROR_OF_MEAN|0.08||0.84|TWO_SIDED|95.0|0.84|1.15|||Mixed Models Analysis|||||1.15|0.84|.84
73875472|NCT03890588|147292890|SUPERIORITY||Risk Ratio (RR)|1.0|STANDARD_ERROR_OF_MEAN|0.11||0.99|TWO_SIDED|95.0|0.8|1.24|||Mixed Models Analysis|||||1.24|.8|.99
73875473|NCT03890588|147292891|SUPERIORITY||Risk Ratio (RR)|1.02|STANDARD_ERROR_OF_MEAN|0.12||0.86|TWO_SIDED|95.0|0.79|1.32|||Mixed Models Analysis|||||1.32|.79|.86
73875474|NCT02756572|147292920|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
73875475|NCT02756572|147292921|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
73875476|NCT02756572|147292922|OTHER|||||||0.049|||||||Fisher Exact|||||||0.049
73875477|NCT02756572|147292923|OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
73875478|NCT02796677|147292996|SUPERIORITY||LS mean difference|0.084|||<|0.0001|TWO_SIDED|95.0|0.051|0.117|||Mixed model for repeated measures|||||0.117|0.051|<0.0001
73875479|NCT02796677|147292997|SUPERIORITY||LS mean difference|0.055||||0.0009|TWO_SIDED|95.0|0.023|0.088|||Mixed model for repeated measures|||||0.088|0.023|0.0009
73875480|NCT02796677|147292998|NON_INFERIORITY|Non-inferiority was established by showing that the lower bound of the two-sided 95% confidence interval for change from baseline in morning pre-dose (trough) FEV1 at week 24 when compared AB 400 μg versus TIO 18 μg was higher than -50 mL (non-inferiority limit).|LS mean difference|0.007||||0.6377|TWO_SIDED|95.0|-0.021|0.035|||Mixed model for repeated measures|||||0.035|-0.021|0.6377
73987759|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|12.542|||TWO_SIDED|95.0|-32.79|20.13|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||20.13|-32.79|
73875481|NCT02796677|147292999|SUPERIORITY||LS mean difference|0.075|||<|0.0001|TWO_SIDED|95.0|0.043|0.107|||Mixed model for repeated measures|||||0.107|0.043|<0.0001
73875482|NCT02796677|147292999|SUPERIORITY||LS mean difference|0.087|||<|0.0001|TWO_SIDED|95.0|0.052|0.122|||Mixed model for repeated measures|||||0.122|0.052|<0.0001
73875483|NCT02796677|147293000|SUPERIORITY||Odds ratio|0.96||||0.8714|TWO_SIDED|95.0|0.61|1.51|||Logistic random-effect model|||||1.51|0.61|0.8714
73875484|NCT02796677|147293000|SUPERIORITY||Odds ratio|0.97||||0.8873|TWO_SIDED|95.0|0.59|1.58|||Logistic random-effect model|||||1.58|0.59|0.8873
73875485|NCT01045967|147293005|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||TWO_SIDED|90.0|90.7|122.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||122|90.7|
73987760|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|6.442|||TWO_SIDED|95.0|-15.87|10.41|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||10.41|-15.87|
73987761|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.89|STANDARD_ERROR_OF_MEAN|50.239|||TWO_SIDED|95.0|-22.04|185.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||185.8|-22.04|
73987762|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.52|STANDARD_ERROR_OF_MEAN|32.896|||TWO_SIDED|95.0|-40.13|93.18|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||93.18|-40.13|
73987763|NCT01568112|147520640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.78|STANDARD_ERROR_OF_MEAN|41.055|||TWO_SIDED|95.0|-31.65|135.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||135.2|-31.65|
73987764|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|2.626|||TWO_SIDED|95.0|-7.35|3.99|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||3.99|-7.35|
73987765|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|-6.62|2.62|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||2.62|-6.62|
73987766|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|5.717|||TWO_SIDED|95.0|-11.64|12.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||12.49|-11.64|
73987767|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.48|STANDARD_ERROR_OF_MEAN|4.597|||TWO_SIDED|95.0|-14.11|5.14||||||Diarrhea||5.14|-14.11|
73987768|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.794|||TWO_SIDED|95.0|-1.1|2.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||2.57|-1.10|
73987769|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.775|||TWO_SIDED|95.0|-1.17|2.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||2.40|-1.17|
74034974|NCT00755846|147622409|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.176||0.017||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.017
74039582|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7546|TWO_SIDED|95.0|0.56|2.22|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.22|0.56|0.7546
73987770|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|1.705|||TWO_SIDED|95.0|-5.08|2.79|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||2.79|-5.08|
73987771|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.56|STANDARD_ERROR_OF_MEAN|27.886|||TWO_SIDED|95.0|-42.19|79.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||79.32|-42.19|
73987772|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|2.801|||TWO_SIDED|95.0|-3.65|8.56|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||8.56|-3.65|
73987773|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.242|||TWO_SIDED|95.0|-3.71|1.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||1.83|-3.71|
73987774|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.83|STANDARD_ERROR_OF_MEAN|19.649|||TWO_SIDED|95.0|-48.73|60.38|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||60.38|-48.73|
73987775|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|11.219|||TWO_SIDED|95.0|-28.38|33.91|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||33.91|-28.38|
73987776|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.36|STANDARD_ERROR_OF_MEAN|9.811|||TWO_SIDED|95.0|-35.56|6.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||6.83|-35.56|
73987777|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.12|STANDARD_ERROR_OF_MEAN|41.961|||TWO_SIDED|95.0|-22.88|157.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||157.1|-22.88|
73987778|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|98.65|STANDARD_ERROR_OF_MEAN|74.566|||TWO_SIDED|95.0|-58.01|255.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||255.3|-58.01|
73987779|NCT01568112|147520641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.27|STANDARD_ERROR_OF_MEAN|7.928|||TWO_SIDED|95.0|-5.22|27.76|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||27.76|-5.22|
73987780|NCT00835510|147520653|SUPERIORITY_OR_OTHER|||||||0.0127||95.0|||||Fisher Exact|two-sided||||||0.0127
73987781|NCT00835510|147520653|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|two-sided||||||<0.0001
73987782|NCT00835510|147520658|NON_INFERIORITY_OR_EQUIVALENCE|The criteria for equivalence is that the 90% confidence interval for the difference in cure rate had to be between -20% to +20%.|Cure rate difference|-19.78||||||90.0|-30.27|-9.29||||||||-9.29|-30.27|
73987783|NCT00526097|147520659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|2.6|4.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.0|2.6|<0.0001
73987784|NCT00526097|147520660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|3.5|5.2||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs)|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.2|3.5|<0.0001
73987785|NCT00526097|147520661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|2.7|4.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.3|2.7|<0.0001
73987786|NCT00526097|147520662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001||95.0|2.0|3.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.6|2.0|<0.0001
73987787|NCT00526097|147520663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|1.8|3.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.4|1.8|<0.0001
73987788|NCT00526097|147520664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|4.1|5.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.8|4.1|<0.0001
73987789|NCT00526097|147520665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001||95.0|5.8|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||7.7|5.8|<0.0001
73987790|NCT00526097|147520666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001||95.0|3.8|5.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.6|3.8|<0.0001
73987791|NCT00526097|147520667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|0.45|<|0.0001||95.0|2.9|4.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.7|2.9|<0.0001
73987792|NCT00526097|147520668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|2.9|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.6|2.9|<0.0001
73987793|NCT00526097|147520669|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||The log-rank test was used to calculate the p-value and to test for differences between the treatment groups.||||<0.0001
73987794|NCT00526097|147520670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.0001||95.0|1.62|2.57|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.57|1.62|<0.0001
73987795|NCT00526097|147520671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75|||<|0.0001||95.0|1.44|2.13|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.13|1.44|<0.0001
73987796|NCT00526097|147520672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08|||<|0.0001||95.0|1.62|2.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.66|1.62|<0.0001
74039583|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7347|TWO_SIDED|95.0|0.57|2.24|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.24|0.57|0.7347
73987797|NCT00526097|147520673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7|||<|0.0001||95.0|1.37|2.11|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.11|1.37|<0.0001
73987798|NCT00526097|147520674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52|||<|0.0001||95.0|1.24|1.88|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||1.88|1.24|<0.0001
73987799|NCT00526097|147520675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.13|||<|0.0001||95.0|4.28|68.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||68.66|4.28|<0.0001
73987800|NCT00526097|147520676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||<|0.0001||95.0|1.81|3.35|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||3.35|1.81|<0.0001
73987801|NCT00526097|147520677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.0025||95.0|1.32|4.74|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||4.74|1.32|0.0025
73987802|NCT00526097|147520678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.08||||0.0105||95.0|1.26|13.24|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||13.24|1.26|0.0105
73987803|NCT00526097|147520679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.4002||95.0|0.52|6.47|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||6.47|0.52|0.4002
73987804|NCT00526097|147520680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||1||95.0|0.37|3.77|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||3.77|0.37|1.0000
73987805|NCT00526097|147520681|SUPERIORITY_OR_OTHER|||||||0.0951|||||||Fisher Exact|||||||0.0951
73987806|NCT00526097|147520682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.09|0.41|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.41|0.09|<0.0001
73987807|NCT00526097|147520683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.2524||95.0|0.02|2.67|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.67|0.02|0.2524
73987808|NCT00526097|147520684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2||||0.0035||95.0|0.06|0.63|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.63|0.06|0.0035
73987809|NCT00526097|147520685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.06||||0.0004||95.0|0.01|0.46|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.46|0.01|0.0004
73987810|NCT00526097|147520686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0086||95.0|0.1|0.69|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.69|0.10|0.0086
73987811|NCT00526097|147520687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-1.2|-0.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.9|-1.2|<0.0001
73987812|NCT00526097|147520688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.2|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.8|-1.2|<0.0001
73987813|NCT00526097|147520689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.1|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.8|-1.1|<0.0001
73987814|NCT00526097|147520690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.9|<0.0001
73875486|NCT01045967|147293006|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.2|||||TWO_SIDED|90.0|86.1|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|86.1|
73987815|NCT00526097|147520691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|2.4|2.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.9|2.4|<0.0001
73987816|NCT00526097|147520692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|2.1|2.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.7|2.1|<0.0001
73987817|NCT00526097|147520693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|2.0|2.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.5|2.0|<0.0001
73987818|NCT00526097|147520694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|1.7|2.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.3|1.7|<0.0001
73987819|NCT00526097|147520695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0002||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0002
73987820|NCT00526097|147520696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0003||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0003
73987821|NCT00526097|147520697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0127||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.2|0.0127
73987822|NCT00526097|147520698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0064||95.0|-0.3|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.3|0.0064
73875487|NCT01045967|147293007|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||TWO_SIDED|90.0|86.3|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|86.3|
73875488|NCT01116401|147293029|SUPERIORITY_OR_OTHER|||||||0.007|||||||Regression, Linear|||||||0.007
73875489|NCT01116401|147293030|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||||||<0.01
73987823|NCT00526097|147520699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.9|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.6|-0.9|<0.0001
73987824|NCT00526097|147520700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.0|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.6|-1.0|<0.0001
73987825|NCT00526097|147520701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.9|<0.0001
73987826|NCT00526097|147520702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.8|<0.0001
73987827|NCT00526097|147520703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.2|<0.0001
73987828|NCT00526097|147520704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|<0.0001
73987829|NCT00526097|147520705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.2|<0.0001
73987830|NCT00526097|147520706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0018||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.2|0.0018
73987831|NCT00526097|147520707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
74039584|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9029|TWO_SIDED|95.0|0.5|1.84|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.84|0.50|0.9029
73875490|NCT01544920|147293064|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 95% CI of the difference in SVR24 % exceeded -10%.|Difference in SVR24% in Arm 2 vs. Arm 1|1.7|||||TWO_SIDED|95.0|-3.2|6.5||||||Difference in percentage of participants achieving SVR24||6.5|-3.2|
73875491|NCT01544920|147293065|NON_INFERIORITY_OR_EQUIVALENCE|The observed lower bound of the 95% CI for the difference was 2.5% (which exceeds 0) for BOC added to peg-IFN + RBV in contrast to peg-IFN + RBV alone.|Difference in SVR24%|10.3|||||TWO_SIDED|95.0|2.5|18.1||||||||18.1|2.5|
73987832|NCT00526097|147520708|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
73987833|NCT00526097|147520709|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
73987834|NCT00526097|147520710|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
73987835|NCT00526097|147520711|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
73987836|NCT00526097|147520712|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
73987837|NCT00526097|147520713|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
73875492|NCT01135134|147293096|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73987838|NCT00526097|147520714|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
73987839|NCT00526097|147520715|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
73987840|NCT00526097|147520716|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
74034975|NCT00755846|147622409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.17||0.001||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.001
73987841|NCT00526097|147520717|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
73987842|NCT00526097|147520718|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
73987843|NCT00526097|147520719|SUPERIORITY_OR_OTHER|||||||0.6773|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.6773
73987844|NCT00526097|147520720|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0002
73987845|NCT00526097|147520721|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0001
73987846|NCT00526097|147520722|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0005
73987847|NCT00526097|147520723|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
73987848|NCT00526097|147520724|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
73987849|NCT00526097|147520725|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
73987850|NCT00526097|147520726|SUPERIORITY_OR_OTHER|||||||0.0058||||||Exact p-value|Wilcoxon rank sum test|||||||0.0058
73987851|NCT00526097|147520727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|2.01||0.798||95.0|-3.4|4.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.5|-3.4|0.7980
74039585|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6402|TWO_SIDED|95.0|0.62|2.18|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.18|0.62|0.6402
74039586|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.17||||0.6199|TWO_SIDED|95.0|0.62|2.2|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.20|0.62|0.6199
73875493|NCT01135134|147293097|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73987852|NCT00526097|147520728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|2.05||0.6129||95.0|-3.0|5.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.1|-3.0|0.6129
73987853|NCT00526097|147520729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.31||0.3567||95.0|-2.4|6.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||6.7|-2.4|0.3567
73987854|NCT00526097|147520730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|1.34||0.1407||95.0|-0.7|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.6|-0.7|0.1407
73987855|NCT00526097|147520731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|1.74||0.013||95.0|0.9|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||7.7|0.9|0.0130
73987856|NCT00526097|147520732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|2.14||0.5849||95.0|-3.0|5.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.3|-3.0|0.5849
73987857|NCT00526097|147520733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.94||0.7543||95.0|-3.2|4.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.4|-3.2|0.7543
73987858|NCT00526097|147520734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|1.58||0.0273||95.0|0.4|6.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||6.6|0.4|0.0273
73987859|NCT00526097|147520735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.87||0.129||95.0|-0.4|3.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.0|-0.4|0.1290
73987860|NCT00526097|147520736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.378||95.0|-0.8|2.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.0|-0.8|0.3780
73987861|NCT00526097|147520737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.6|-0.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.3|-0.6|<0.0001
73987862|NCT00526097|147520738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.0|-0.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.7|-1.0|<0.0001
73987863|NCT00526097|147520739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.007||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0070
73987864|NCT00526097|147520740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-1.5|-1.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-1.0|-1.5|<0.0001
73987865|NCT00526097|147520741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.8|<0.0001
73987866|NCT03713281|147520757|SUPERIORITY||Least-square mean|-0.131|STANDARD_ERROR_OF_MEAN|0.0278|||TWO_SIDED|95.0|-0.208|-0.054|||Linear Mixed Model|Kenward and Roger modethod for the demoninator degrees of freedom.||Statistically superiority will be concluded if the upper confidence limit will be less than 0.10 logMAR.||-0.054|-0.208|
73987867|NCT03713281|147520758|SUPERIORITY||Least-square means|0.06|STANDARD_ERROR_OF_MEAN|0.0278|||TWO_SIDED|95.0|-0.017|0.137|||Linear Mixed Model|Kenward and Roger method for the demoninator degrees of freedom.||Statistically superiority will be concluded if the upper confidence limit will be less than 0.17 logMAR for near distance logMAR visual acuity.||0.137|-0.017|
73987868|NCT01772823|147520803|OTHER|||||||0.7513||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Size of the Pill) differ between intervention arms."|Chi-squared|||||||0.7513
73987869|NCT01772823|147520804|OTHER|||||||0.8281||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Taste of the Pill) differ between intervention arms."|Chi-squared|Pearson Chi-Square||||||0.8281
73987870|NCT01772823|147520805|OTHER|||||||0.3761||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Color of the Pill) differ between intervention arms."|Chi-squared|||||||0.3761
73987871|NCT01772823|147520806|OTHER|||||||0.4359||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking the pill every day) differ between intervention arms."|Chi-squared|||||||0.4359
73987872|NCT01772823|147520807|OTHER|||||||0.3801||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking part in the study) differ between intervention arms."|Chi-squared|||||||0.3801
73987873|NCT01772823|147520808|OTHER|||||||0.1968||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on HIV test at every visit) differ between intervention arms."|Chi-squared|||||||0.1968
73987874|NCT01772823|147520809|OTHER|||||||0.1226||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Risk Reduction counseling at every visit) differ between intervention arms."|Chi-squared|||||||0.1226
73987875|NCT01772823|147520810|OTHER|||||||0.0994||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Questions about sexual behavior) differ between intervention arms."|Chi-squared|||||||0.0994
73987876|NCT01772823|147520811|OTHER|||||||0.5285||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Physician exam) differ between intervention arms."|Chi-squared|||||||0.5285
73987877|NCT01772823|147520815|OTHER|||||||0.0001||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0001
73987878|NCT01772823|147520816|OTHER|||||||0.0098||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0098
73987879|NCT01772823|147520817|OTHER|||||||0.0766||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0766
73987880|NCT01772823|147520818|OTHER|||||||0.1581||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1581
73987881|NCT01772823|147520819|OTHER|||||||0.43||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.4300
73875494|NCT00255190|147293098|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.042
73875495|NCT00255190|147293099|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.006
73875496|NCT00255190|147293100|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using a one-way analysis of covariance (ANCOVA) model with treatment as the factor and baseline score as the covariate.||||||0.204
73875497|NCT00255190|147293101|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.109
73875498|NCT00255190|147293102|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||<0.001
73875499|NCT00255190|147293103|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.494
73875500|NCT00255190|147293104|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.026
73875501|NCT00255190|147293105|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.220
73987882|NCT01772823|147520820|OTHER|||||||0.1201||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1201
73987883|NCT01772823|147520821|OTHER|||||||0.1682||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1682
73875502|NCT00255190|147293106|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.843
73875503|NCT00255190|147293107|SUPERIORITY_OR_OTHER|||||||0.923||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.923
73987884|NCT01772823|147520822|OTHER|||||||0.2747||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.2747
73987885|NCT01772823|147520823|OTHER|||||||0.0046||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0046
73987886|NCT01772823|147520824|OTHER|||||||0.029||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0290
73987887|NCT01772823|147520825|OTHER|||||||0.107|||||||Kruskal-Wallis|||||||0.1070
73987888|NCT01772823|147520827|OTHER|||||||0.2991||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.2991
73987889|NCT01772823|147520828|OTHER|||||||0.0298||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.0298
73987890|NCT01772823|147520829|OTHER|||||||0.8643||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified ethnicity) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.8643
73875504|NCT00255190|147293108|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||<0.001
73875505|NCT00255190|147293109|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.758
73875506|NCT00255190|147293110|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.737
73875507|NCT00255190|147293111|SUPERIORITY_OR_OTHER|||||||0.673||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.673
73875508|NCT00255190|147293112|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.817
73875509|NCT00255190|147293113|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.601
73875510|NCT00255190|147293114|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.065
73987891|NCT01772823|147520830|OTHER|||||||0.9037||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant BMI) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.9037
73987892|NCT01772823|147520831|OTHER|||||||0.5279|||||||Kruskal-Wallis|||||||0.5279
73987893|NCT01772823|147520832|OTHER|||||||0.5369||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participation in high-risk sex acts) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.5369
73987894|NCT01772823|147520835|OTHER|||||||0.2193||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2193
73987895|NCT01772823|147520836|OTHER|||||||0.1255||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1255
73987896|NCT01772823|147520837|OTHER|||||||0.0706||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0706
73987897|NCT01772823|147520838|OTHER|||||||0.0088||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0088
73987898|NCT01772823|147520839|OTHER|||||||0.2482||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2482
73987899|NCT01772823|147520840|OTHER|||||||0.1647||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1647
73987900|NCT01772823|147520841|OTHER|||||||0.688||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.6880
73987901|NCT01772823|147520842|OTHER|||||||0.2881||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2881
74039587|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0229|TWO_SIDED|95.0|1.05|1.83|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.05|0.0229
73875511|NCT00255190|147293115|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.319
73987902|NCT01772823|147520843|OTHER|||||||0.2223||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2223
73987903|NCT01772823|147520844|OTHER|||||||0.0617||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0617
73987904|NCT01772823|147520845|OTHER|||||||0.0868||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0868
73987905|NCT01772823|147520846|OTHER|||||||0.1847||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1847
73987906|NCT01772823|147520847|OTHER|||||||0.0226||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0226
73987907|NCT01670188|147520863|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
73987908|NCT00413634|147520872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||ANOVA|||||||0.092
73987909|NCT00413634|147520875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.857||95.0|||||ANOVA|||||||0.857
73987910|NCT00413634|147520876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0|||||ANOVA|||||||0.013
73987911|NCT00413634|147520877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.378||95.0|||||ANOVA|||||||0.378
73987912|NCT00413634|147520878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0|||||ANOVA|||||||0.013
73987913|NCT00413634|147520879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0|||||ANOVA|||||||0.035
73987914|NCT00413634|147520880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0|||||ANOVA|||||||0.023
73987915|NCT00413634|147520881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557||95.0|||||ANOVA|||||||0.557
73987916|NCT00413634|147520882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0|||||ANOVA|||||||0.027
73987917|NCT00413634|147520883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||ANOVA|||||||0.007
73987918|NCT00413634|147520884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0|||||ANOVA|||||||0.027
73987919|NCT00413634|147520885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||95.0|||||ANOVA|||||||0.011
73987920|NCT04148521|147520899|SUPERIORITY||Odds Ratio (OR)|1.15||||0.27|TWO_SIDED|95.0|0.9|1.47|||Mixed Models Analysis|||||1.47|0.90|0.27
73987921|NCT04148521|147520900|SUPERIORITY||Odds Ratio (OR)|1.04||||0.83|TWO_SIDED|95.0|0.75|1.43|||Mixed Models Analysis|||||1.43|0.75|0.83
73987922|NCT04148521|147520901|SUPERIORITY||Odds Ratio (OR)|1.43||||0.12|TWO_SIDED|95.0|0.91|2.26|||Mixed Models Analysis|||||2.26|0.91|0.12
73987923|NCT04148521|147520902|SUPERIORITY||Odds Ratio (OR)|1.17||||0.51|TWO_SIDED|95.0|0.73|1.86|||Mixed Models Analysis|||||1.86|0.73|0.51
74039588|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0002|TWO_SIDED|95.0|1.3|2.3|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.30|1.30|0.0002
73987924|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-79.33|||<|0.001|TWO_SIDED|95.0|-87.54|-65.73|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-65.73|-87.54|< 0.001
73987925|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-71.16|||<|0.001|TWO_SIDED|95.0|-82.67|-52.0|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.00|-82.67|< 0.001
74034976|NCT00755846|147622409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.174||0.003||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.003
74034977|NCT00755846|147622409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.173||0.307||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.307
74034978|NCT00755846|147622410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.106||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.004
74034979|NCT00755846|147622410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.134||0.017||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.017
74034980|NCT00755846|147622410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.138||0.016||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.016
74034981|NCT00755846|147622410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.134||0.005||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.005
74034982|NCT00755846|147622410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.137||0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.008
73875512|NCT00255190|147293116|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.011
73875513|NCT00255190|147293117|SUPERIORITY_OR_OTHER|||||||0.207||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.207
73875514|NCT00255190|147293118|SUPERIORITY_OR_OTHER|||||||0.286||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.286
73875515|NCT00255190|147293119|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.102
73875516|NCT00255190|147293120|SUPERIORITY_OR_OTHER|||||||0.656||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.656
73987926|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-79.52|||<|0.001|TWO_SIDED|95.0|-88.29|-64.17|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-64.17|-88.29|< 0.001
73987927|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-72.34|||<|0.001|TWO_SIDED|95.0|-83.32|-54.13|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-54.13|-83.32|< 0.001
73987928|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-73.03|||<|0.001|TWO_SIDED|95.0|-83.79|-55.11|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-55.11|-83.79|< 0.001
73987929|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-71.88|||<|0.001|TWO_SIDED|95.0|-83.93|-50.82|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-50.82|-83.93|< 0.001
74089813|NCT00262041|147732526|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.||||||0.071||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup W compared with that of MenACWY PS vaccine.||||0.071
73875517|NCT00255190|147293121|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.176
73875518|NCT00255190|147293122|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.030
73875519|NCT00255190|147293123|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.243
73875520|NCT00255190|147293124|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.005
73875521|NCT00255190|147293125|SUPERIORITY_OR_OTHER|||||||0.469||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.469
73875522|NCT03246789|147293185|SUPERIORITY||Mean Difference (Final Values)|2.15||||0.31|TWO_SIDED|95.0|-2.09|6.39|||t-test, 2 sided|||Week 12||6.39|-2.09|0.31
73875523|NCT03246789|147293186|SUPERIORITY||Mean Difference (Final Values)|-1.47||||0.28|TWO_SIDED|95.0|-4.22|1.28|||t-test, 2 sided|||Domain #1, Week 12||1.28|-4.22|0.28
73875524|NCT03246789|147293186|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.5|TWO_SIDED|95.0|-3.48|1.74|||t-test, 2 sided|||Domain #2, Week 12||1.74|-3.48|0.50
73875525|NCT03246789|147293186|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.02|TWO_SIDED|95.0|-2.88|-0.28|||t-test, 2 sided|||Domain #3, Week 12||-0.28|-2.88|0.02
73987930|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-68.51|||<|0.001|TWO_SIDED|95.0|-81.01|-47.78|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-47.78|-81.01|< 0.001
73987931|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-81.06|||<|0.001|TWO_SIDED|95.0|-88.62|-68.49|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-68.49|-88.62|< 0.001
73987932|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-79.04|||<|0.001|TWO_SIDED|95.0|-88.02|-63.34|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-63.34|-88.02|< 0.001
73987933|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-32.7||||0.25|TWO_SIDED|95.0|-65.71|32.1|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||32.10|-65.71|0.25
73987934|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|3.44||||0.9|TWO_SIDED|95.0|-40.78|80.66|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||80.66|-40.78|0.90
73987935|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-40.53||||0.091|TWO_SIDED|95.0|-67.5|8.82|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||8.82|-67.50|0.091
73987936|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|13.33||||0.73|TWO_SIDED|95.0|-44.39|130.94|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||130.94|-44.39|0.73
73987937|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-80.02||||0.001|TWO_SIDED|95.0|-91.53|-52.87|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.87|-91.53|0.001
73987938|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-87.6|||<|0.001|TWO_SIDED|95.0|-94.53|-71.88|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-71.88|-94.53|< 0.001
73987939|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Rratio|-79.81||||0.001|TWO_SIDED|95.0|-91.44|-52.37|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.37|-91.44|0.001
74034983|NCT00755846|147622410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.136||0.321||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.321
74034984|NCT00755846|147622411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|STANDARD_ERROR_OF_MEAN|6.65|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting plasma glucose (FPG). The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
74039589|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.14||||0.315|TWO_SIDED|95.0|0.88|1.47|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.47|0.88|0.3150
73875526|NCT03246789|147293186|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.98|TWO_SIDED|95.0|-3.63|3.53|||t-test, 2 sided|||Domain 4, Week 12||3.53|-3.63|0.98
73987940|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-83.66|||<|0.001|TWO_SIDED|95.0|-92.79|-62.95|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-62.95|-92.79|< 0.001
73987941|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-81.97|||<|0.001|TWO_SIDED|95.0|-92.35|-57.46|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-57.46|-92.35|< 0.001
73987942|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-84.39|||<|0.001|TWO_SIDED|95.0|-93.12|-64.6|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-64.60|-93.12|< 0.001
73987943|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|43.1||||0.47|TWO_SIDED|95.0|-47.06|286.83|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||286.83|-47.06|0.47
73987944|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-68.58||||0.02|TWO_SIDED|95.0|-88.02|-17.63|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-17.63|-88.02|0.020
73987945|NCT01723514|147520915|SUPERIORITY||LS Geometric Mean Ratio|-54.32||||0.11|TWO_SIDED|95.0|-82.58|19.75|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||19.75|-82.58|0.11
73987946|NCT00510146|147521004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.018|TWO_SIDED|95.0|-3.93|-0.36||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in MADRS total score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.36|-3.93|0.018
73987947|NCT00510146|147521005|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic response at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.050
73987948|NCT00510146|147521006|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic remission at any time from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel|||||||0.367
73987949|NCT00510146|147521007|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.11||||0.008|TWO_SIDED|95.0|-0.2|-0.03||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Mania score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.03|-0.20|0.008
73987950|NCT00510146|147521007|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.24||||0.037|TWO_SIDED|95.0|-0.47|-0.01||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Depression score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.01|-0.47|0.037
73987951|NCT00510146|147521007|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.008|TWO_SIDED|95.0|-0.53|-0.08||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Overall score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.08|-0.53|0.008
73987952|NCT00510146|147521008|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with recovery from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel|||||||0.156
73987953|NCT00510146|147521009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||<|0.001|TWO_SIDED|95.0|-1.56|-0.43||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.43|-1.56|<0.001
73987954|NCT00510146|147521010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.002|TWO_SIDED|95.0|-3.61|-0.81||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.81|-3.61|0.002
73987955|NCT00510146|147521011|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.297
73987956|NCT00510146|147521011|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode with melancholic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.264
73987957|NCT00510146|147521012|SUPERIORITY_OR_OTHER|||||||0.195||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current hypomanic episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.195
73987958|NCT00510146|147521013|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current psychotic disorders from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.163
73875527|NCT03246789|147293187|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.92|TWO_SIDED|95.0|-0.64|0.58|||t-test, 2 sided|||Domain #1, Week 12||0.58|-0.64|0.92
73875528|NCT03246789|147293187|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.48|TWO_SIDED|95.0|-0.69|0.33|||t-test, 2 sided|||Domain #2, Week 12||0.33|-0.69|0.48
73987959|NCT00510146|147521013|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current mood disorders with psychotic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.442
73987960|NCT00510146|147521014|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol dependence from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||1.00
73987961|NCT00510146|147521014|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol abuse from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.324
73987962|NCT00510146|147521016|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with emergence of mania at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.031
73987963|NCT00510146|147521017|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (akathisia) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.269
73875529|NCT03246789|147293187|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.48|TWO_SIDED|95.0|-0.33|0.69|||t-test, 2 sided|||||0.69|-0.33|0.48
73875530|NCT01292187|147293205|SUPERIORITY_OR_OTHER|||||||0.0265|||||||Mixed Models Analysis|||||||0.0265
73987964|NCT00510146|147521017|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (parkinsonism) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.736
73987965|NCT00510146|147521018|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.146
73987966|NCT00510146|147521018|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.249
74039590|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.21||||0.137|TWO_SIDED|95.0|0.94|1.57|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.57|0.94|0.1370
73875531|NCT01292187|147293206|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||||||0.0340
73875532|NCT02119871|147293207|SUPERIORITY||Median Difference (Final Values)|14.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
73987967|NCT00510146|147521018|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.146
73987968|NCT00510146|147521018|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.271
73987969|NCT00510146|147521018|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.284
73987970|NCT00510146|147521018|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.067
73987971|NCT00510146|147521019|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in weight from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
73987972|NCT00510146|147521020|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in fasting glucose from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.179
73987973|NCT00510146|147521020|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
73987974|NCT00510146|147521020|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in triglycerides from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.003
73875533|NCT02119871|147293208|SUPERIORITY||Median Difference (Final Values)|10.0||||0.656|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.656
73875534|NCT02119871|147293209|SUPERIORITY||Median Difference (Final Values)|4.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1
73875535|NCT01216202|147293218|SUPERIORITY|||||||0.014||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||The association between change in serum testosterone levels and cumulative mean testicular radiation dose was assessed using longitudinal regression analysis (GEE). No preoperative RT contributed with baseline values.||||0.014
73875536|NCT01216202|147293219|SUPERIORITY||Estimated mean change|-4.0||||0.008|TWO_SIDED|95.0|-6.9|-1.0||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for time between preoperative radiotherapy (RT) and surgery.||The association between change in total number of sperms per ejaculate and relative mean testicular dose was assessed using longitudinal regression analysis (GEE).||-1.0|-6.9|0.008
73875537|NCT03483896|147293237|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
73875538|NCT03483896|147293238|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
73875539|NCT02888106|147293239|SUPERIORITY|||||||0.0022|||||||Fisher Exact|||The proportions of negative HDV RNA response at week 72 in each of the MXB treatment groups were compared with the control group of PEG-IFNα by using Fisher's exact test and by presenting exact unconditional 95%-confidence intervals (CI) based on scores for the proportion differences.||||0.0022
73987975|NCT00510146|147521020|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in LDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
73987976|NCT00510146|147521020|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in HDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.095
73875540|NCT02888106|147293239|SUPERIORITY|||||||0.0996|||||||Fisher Exact|||||||0.0996
73875541|NCT02888106|147293239|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
73875542|NCT02888106|147293239|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
73875543|NCT02888106|147293239|SUPERIORITY|||||||0.0421|||||||Fisher Exact|||||||0.0421
73875544|NCT02888106|147293240|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||Week 24||||0.0052
73875545|NCT02888106|147293240|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||Week 24||||0.0052
73987977|NCT00510146|147521021|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in albumin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
73987978|NCT00510146|147521022|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in ALT/SGPT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
73875546|NCT02888106|147293240|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
73875547|NCT02888106|147293240|SUPERIORITY|||||||0.0017|||||||Fisher Exact|||Week 24||||0.0017
73875548|NCT02888106|147293240|SUPERIORITY|||||||0.3295|||||||Fisher Exact|||Week 24||||0.3295
73987979|NCT00510146|147521022|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in AST/SGOT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
73987980|NCT00510146|147521022|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in GGT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
73987981|NCT00510146|147521023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in direct bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
74039591|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0018|TWO_SIDED|95.0|1.17|1.97|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.97|1.17|0.0018
73875549|NCT02888106|147293240|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 48||||0.0007
73987982|NCT00510146|147521023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in total bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
73875550|NCT02888106|147293240|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||Week 48||||0.0001
73875551|NCT02888106|147293240|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
73875552|NCT02888106|147293240|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 48||||0.0007
73875553|NCT02888106|147293240|SUPERIORITY|||||||0.1086|||||||Fisher Exact|||Week 48||||0.1086
73875554|NCT02888106|147293241|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
73875555|NCT02888106|147293241|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
73875556|NCT02888106|147293241|SUPERIORITY|||||||0.0002|||||||Fisher Exact|||Week 24||||0.0002
73875557|NCT02888106|147293241|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
73875558|NCT02888106|147293241|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 24||||0.0007
73875559|NCT02888106|147293241|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
73875560|NCT02888106|147293241|SUPERIORITY|||||||0.4497|||||||Fisher Exact|||Week 48||||0.4497
73875561|NCT02888106|147293241|SUPERIORITY|||||||0.0268|||||||Fisher Exact|||Week 48||||0.0268
73875562|NCT02888106|147293241|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
73875563|NCT02888106|147293241|SUPERIORITY|||||||0.6999|||||||Fisher Exact|||Week 48||||0.6999
73875564|NCT02888106|147293241|SUPERIORITY|||||||0.0743|||||||Fisher Exact|||Week 72||||0.0743
73875565|NCT02888106|147293241|SUPERIORITY|||||||0.3449|||||||t-test, 1 sided|||Week 72||||0.3449
73875566|NCT02888106|147293241|SUPERIORITY|||||||0.6036|||||||Fisher Exact|||Week 72||||0.6036
73875567|NCT02888106|147293241|SUPERIORITY|||||||0.3408|||||||Fisher Exact|||Week 72||||0.3408
73875568|NCT02888106|147293241|SUPERIORITY|||||||0.3408|||||||Fisher Exact|||Week 72||||0.3408
73875569|NCT02888106|147293242|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
73875570|NCT02888106|147293242|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
73875571|NCT02888106|147293242|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
73875572|NCT02888106|147293242|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
73875573|NCT02888106|147293242|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
73875574|NCT02888106|147293242|SUPERIORITY|||||||0.5977|||||||Fisher Exact|||Week 48||||0.5977
73875575|NCT02888106|147293242|SUPERIORITY|||||||0.1686|||||||Fisher Exact|||Week 48||||0.1686
73875576|NCT02888106|147293242|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
73875577|NCT02888106|147293242|SUPERIORITY|||||||0.5977|||||||Fisher Exact|||Week 48||||0.5977
73875578|NCT02888106|147293242|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
73987983|NCT00510146|147521023|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in uric acid from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
73875579|NCT02888106|147293242|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||Week 72||||0.0063
73987984|NCT00510146|147521024|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in erythrocyte count from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.003
73987985|NCT00510146|147521025|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hematocrit from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
73987986|NCT00510146|147521026|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin A1c from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.009
73987987|NCT00510146|147521027|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
73987988|NCT00510146|147521028|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in prolactin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
73987989|NCT00510146|147521029|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in urinalysis-specific gravity from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
73987990|NCT00510146|147521030|SUPERIORITY_OR_OTHER|||||||0.104||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcF interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.104
73987991|NCT00510146|147521030|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcB interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.006
73987992|NCT00510146|147521031|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in heart rate from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.035
73987993|NCT00510146|147521032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.943|TWO_SIDED|95.0|-0.59|0.64||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint for MINI Suicidality Total Score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||0.64|-0.59|0.943
73875580|NCT02888106|147293242|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
73875581|NCT02888106|147293242|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
73875582|NCT02888106|147293242|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
73875583|NCT02888106|147293242|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
73875584|NCT02888106|147293243|SUPERIORITY|||||||0.0801|||||||Fisher Exact|||Week 24||||0.0801
73875585|NCT02888106|147293243|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
73875586|NCT02888106|147293243|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
73875587|NCT02888106|147293243|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
73987994|NCT00510146|147521040|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||p-value represents change from baseline to endpoint-standing diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.736
73987995|NCT00510146|147521040|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||p-value represents change from baseline to endpoint-sitting diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.944
73987996|NCT00510146|147521040|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||p-value represents change from baseline to endpoint-standing systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.080
73987997|NCT00510146|147521040|SUPERIORITY_OR_OTHER|||||||0.612||95.0||||p-value represents change from baseline to endpoint-sitting systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.612
73987998|NCT00510146|147521040|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||p-value represents change from baseline to endpoint-orthostatic change in diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.640
73987999|NCT00510146|147521040|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||p-value represents change from baseline to endpoint-orthostatic change in systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.122
73988000|NCT00510146|147521041|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for weight from t-tests on change.|t-test, 2 sided|||||||<0.001
73988001|NCT00510146|147521042|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for albumin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
73988002|NCT00510146|147521042|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value represents change from baseline to endpoint for total protein from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.002
73988003|NCT00510146|147521043|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value represents change from baseline to endpoint for alkaline phosphatase from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.002
73988004|NCT00510146|147521043|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value represents change from baseline to endpoint for CPK from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.010
73988005|NCT00510146|147521043|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||p-value represents change from baseline to endpoint for GGT from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.354
73988006|NCT00510146|147521044|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value represents change from baseline to endpoint for chlorine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.010
73875588|NCT02888106|147293243|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
73988007|NCT00510146|147521045|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for creatinine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
73988008|NCT00510146|147521046|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||p-value represents change from baseline to endpoint for erythrocyte count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.021
73988009|NCT00510146|147521047|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||p-value represents change from baseline to endpoint for hemoglobin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.035
73988010|NCT00510146|147521048|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value represents change from baseline to endpoint for platelet count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.024
73988011|NCT00510146|147521049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for prolactin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
73988012|NCT00510146|147521050|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for uric acid from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
73988013|NCT00510146|147521051|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||p-value represents change from baseline to endpoint for fasting glucose from t-tests on change.|t-test, 2 sided|||||||0.047
73988014|NCT00510146|147521051|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||p-value represents change from baseline to endpoint for cholesterol from t-tests on change.|t-test, 2 sided|||||||0.130
73988015|NCT00510146|147521051|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||p-value represents change from baseline to endpoint for triglycerides from t-tests on change.|t-test, 2 sided|||||||0.055
73988016|NCT00510146|147521051|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||p-value represents change from baseline to endpoint for LDL cholesterol from t-tests on change.|t-test, 2 sided|||||||0.049
73988017|NCT00510146|147521051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for HDL cholesterol from t-tests on change.|t-test, 2 sided|||||||<0.001
73875589|NCT02888106|147293243|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||Week 48||||0.0063
73988018|NCT00510146|147521052|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||p-value represents change from baseline to endpoint for QTcF from t-test.|t-test, 2 sided|||||||0.023
73988019|NCT00510146|147521052|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value represents change from baseline to endpoint for QTcB from t-test.|t-test, 2 sided|||||||0.044
73988020|NCT00510146|147521053|SUPERIORITY_OR_OTHER|||||||0.919||95.0||||p-value represents change from baseline to endpoint for heart rate from t-test.|t-test, 2 sided|||||||0.919
73988021|NCT00519285|147521131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.3802|TWO_SIDED|95.6|0.822|1.08||A priori threshold for statistical significance was set to 0.044 using the O'Brien-Fleming alpha spending function to account for two interim analyses.|Log Rank|Log rank test stratified on ECOG Performance Status|Hazard ratio (HR) aflibercept versus placebo estimated from a Cox proportional hazard model stratified on ECOG Performance Status|"Null hypothesis: No difference between aflibercept and placebo~The study was designed to provide 90% power to detect a 1.25-fold increase in median survival with aflibercept compared to placebo at a overall one-sided significance level of 0.025 with 873 deaths."||1.08|0.822|0.3802
73988022|NCT01149876|147521142|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
73988023|NCT01149876|147521142|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||.25
73988024|NCT01149876|147521142|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||.48
73988025|NCT00988117|147521211|SUPERIORITY_OR_OTHER||Tscore|5.19|||<|0.01||95.0||||t-tests were statistically thresholded using the joint probability distribution method to correct for multiple comparisons, p \< 0.01 for voxel height and p \< 0.05 for cluster extent|t-test, 2 sided|A mask included only those regions where the patients showed abnormally low fALFF at either timepoint relative to a sample of 15 age-matched controls.||"Each voxel's BOLD signal time series was detrended and transformed to the frequency domain. We divided the sum of the square roots across the 0.01-0.08 Hz range by that across the entire frequency range (0-0.25 Hz).~fALFF group comparisons were evaluated using t-tests corrected for multiple comparisons. To determine if there were treatment-associated changes in brain activity, we compared voxel-wise fALFF in the patients at baseline to post-treatment."||||<0.01
73988026|NCT00988117|147521212|SUPERIORITY_OR_OTHER||pearson's r correlation coefficient|-0.82|||<|0.01||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left inferior frontal gyrus / premotor falff change||||<.01
73988027|NCT00988117|147521212|SUPERIORITY_OR_OTHER||pearson's correlation coefficient|-0.35||||0.36||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change||||.36
73988028|NCT00988117|147521213|SUPERIORITY_OR_OTHER||pearson's r correlation|0.18||||0.58||95.0|||||Regression, Linear|||correlation with left premotor / inferior frontal gyri falff change||||.58
73988029|NCT00988117|147521213|SUPERIORITY_OR_OTHER||pearson's correlation coefficient|0.26||||0.41||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change||||.41
73875590|NCT02888106|147293243|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 48||||0.2241
73875591|NCT02888106|147293243|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
73988030|NCT00702273|147521214|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin of -8%|Risk Difference (RD)|2.4|||||TWO_SIDED|95.0|-2.6|7.4||||||Treatment groups were compared with a generalized linear model including covariates treatment group, age class and region.||7.4|-2.6|
73988031|NCT00513461|147521221|SUPERIORITY||Mean Difference (Net)|7.78||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.160
73988032|NCT00513461|147521234|SUPERIORITY||Mean Difference (Net)|0.43||||0.878|TWO_SIDED||||||Two-Group t-test|||||||0.878
73988033|NCT00513461|147521235|SUPERIORITY||Mean Difference (Net)|-3.66||||0.212|TWO_SIDED||||||Two-Group t-test|||||||0.212
73988034|NCT02551692|147521354|OTHER||Partial sum of squares|855.65||||0.534|TWO_SIDED||||||ANOVA|||||||0.534
73988035|NCT02551692|147521355|OTHER||Partial sum of squares|29602.69||||0.26|TWO_SIDED||||||ANOVA|||||||0.26
73988036|NCT02551692|147521356|OTHER||Partial sum of squares|101.69||||0.318|TWO_SIDED||||||ANCOVA|||||||0.318
73988037|NCT04167085|147521401|SUPERIORITY|||||||0.16||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.16
73875592|NCT02888106|147293243|SUPERIORITY|||||||0.0169|||||||Regression, Cox|||Week 72||||0.0169
73875593|NCT02888106|147293243|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
73875594|NCT02888106|147293243|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
73875595|NCT02888106|147293244|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 48||||0.4828
73875596|NCT02888106|147293244|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
73988038|NCT04167085|147521402|SUPERIORITY|||||||0.05||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.05
73988039|NCT04167085|147521403|SUPERIORITY|||||||0.19||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.19
73988040|NCT04167085|147521404|SUPERIORITY|||||||0.24||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||SF-12 Physical||||0.24
73988041|NCT04167085|147521404|SUPERIORITY|||||||0.35||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||SF-12 Mental||||0.35
73988042|NCT04167085|147521405|SUPERIORITY|||||||0.5||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||0.50
73988043|NCT04167085|147521406|SUPERIORITY|||||||0.3||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||0.30
74034985|NCT00755846|147622411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.5|STANDARD_ERROR_OF_MEAN|8.4|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
74039592|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0342|TWO_SIDED|95.0|1.02|1.81|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.81|1.02|0.0342
73875597|NCT02888106|147293244|SUPERIORITY|||||||0.2292|||||||Fisher Exact|||Week 72||||0.2292
73875598|NCT02888106|147293244|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
73875599|NCT02888106|147293245|SUPERIORITY|||||||0.4621|||||||Fisher Exact|||Week 24||||0.4621
73875600|NCT02888106|147293245|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||Week 24||||1.0000
73875601|NCT02888106|147293245|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
73875602|NCT02888106|147293245|SUPERIORITY|||||||0.4621|||||||Fisher Exact|||Week 24||||0.4621
73875603|NCT02888106|147293245|SUPERIORITY|||||||0.0253|||||||Fisher Exact|||Week 24||||0.0253
73875604|NCT02888106|147293245|SUPERIORITY|||||||0.0268|||||||Fisher Exact|||Week 48||||0.0268
73875605|NCT02888106|147293245|SUPERIORITY|||||||0.6999|||||||Fisher Exact|||Week 48||||0.6999
73875606|NCT02888106|147293245|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
73875607|NCT02888106|147293245|SUPERIORITY|||||||0.0656|||||||Fisher Exact|||Week 48||||0.0656
73875608|NCT02888106|147293245|SUPERIORITY|||||||0.0005|||||||Fisher Exact|||Week 48||||0.0005
73875609|NCT02888106|147293245|SUPERIORITY|||||||0.1431|||||||Fisher Exact|||Week 72||||0.1431
73875610|NCT02888106|147293245|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
73875611|NCT02888106|147293245|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
73875612|NCT02888106|147293245|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
73875613|NCT02888106|147293245|SUPERIORITY|||||||0.7104|||||||Fisher Exact|||Week 72||||0.7104
73988044|NCT04167085|147521407|SUPERIORITY|||||||1||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||1.00
73988045|NCT02811302|147521417|OTHER|A simple count and percentage of the population were calculated based on the number of patients adjudicated as having Respiratory Depression.|||||||||||||||||To determine the risk assessment score, first the number of patients with Respiratory Depression (RD) had to be identified. Per the rules established for the Clinical Endpoint Committee, 655 (43.6%) patients were identified as having RD.|||
73988046|NCT02811302|147521418|OTHER|Multivariable model for (Multivariate logistic regression) Respiratory Depression, followed by validation with Harrell's Optimism using a bootstrap sampling method.|Area Under the Curve|0.76|||||TWO_SIDED|95.0|0.73|0.79|||||The model was performed using stepwise selection including all potential predictors and interactions terms (medical history and baseline characteristics).|A modified Full Analysis Dataset (1335) was used to derive and validate the risk assessment tool. Subjects were excluded if they had major deviations or consent withdrawals. Subjects that did not have any monitoring data were also excluded. Finally, 69 subjects were further excluded from the model, as they were missing parameters to calculate their risk score.|The model derived from the logistic regression was assessed by the Hosmer-Lemshow goodness of fit test (P = 0.831). The derived model was validated by Harrell's Optimism using a Bootstrap sampling method (500 samples from the modified dataset, 1335) with replacement. The logistic regression model with stepwise selection was performed for each bootstrap sample, and AUC calculated. The optimism calculated by Harrell's algorithm was 0.02. The model was then checked for the quartiles of the effective monitoring and for geography used as a random effect. The performance measurement of the final model was adjusted according the Harrell's Optimism for a final adjusted AUC of 0.74.|0.79|0.73|
73988047|NCT00942188|147521427|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.854|||||TWO_SIDED|95.0|-1.94|0.23|||ANCOVA|||||0.23|-1.94|
73988048|NCT00942188|147521427|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.252|||||TWO_SIDED|95.0|-2.48|-0.03|||ANCOVA|||||-0.03|-2.48|
73988049|NCT00942188|147521427|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|||||TWO_SIDED|95.0|-1.76|0.54|||ANCOVA|||||0.54|-1.76|
73988050|NCT00942188|147521428|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.995|||||TWO_SIDED|95.0|-9.82|3.83|||ANCOVA|||||3.83|-9.82|
73988051|NCT00942188|147521428|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.324|||||TWO_SIDED|95.0|-10.21|5.56|||ANCOVA|||||5.56|-10.21|
73988052|NCT00942188|147521428|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.635|||||TWO_SIDED|95.0|-9.16|5.89|||ANCOVA|||||5.89|-9.16|
73988053|NCT00942188|147521430|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.59|0.05||This is the estimated value for week 10 HbA1c.|ANCOVA|||||0.05|-0.59|
73875614|NCT00287716|147293272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.023|TWO_SIDED|95.0|0.44|0.95|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403 mg/day treatment group and the placebo treatment group.||0.95|0.44|0.023
73875615|NCT00287716|147293278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.515|TWO_SIDED|95.0|0.5|1.42|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403-mg/d treatment group and the placebo treatment group.||1.42|0.50|0.515
73988054|NCT00942188|147521430|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.369|||||TWO_SIDED|95.0|-0.74|0.0||This is the estimated value for HbA1c at Week 10.|ANCOVA|||||0.00|-0.74|
73988055|NCT00942188|147521430|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.227|||||TWO_SIDED|95.0|-0.59|0.13||This is the estimated value for HbA1c at Week 10.|ANCOVA|||||0.13|-0.59|
73988056|NCT00942188|147521430|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.267|||||TWO_SIDED|95.0|-0.61|0.08||This is the estimated value for HbA1c at week 12.|ANCOVA|||||0.08|-0.61|
73988057|NCT00942188|147521430|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.396|||||TWO_SIDED|95.0|-0.79|0.0||This is the estimated value for HbA1c at Week 12.|ANCOVA|||||0.00|-0.79|
73988058|NCT00942188|147521430|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.221|||||TWO_SIDED|95.0|-0.59|0.15||This is the estimated value for HbA1c at week 12.|ANCOVA|||||0.15|-0.59|
73988059|NCT00276016|147521434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0|||||ANOVA|||For endpoint||||0.561
73988060|NCT00276016|147521435|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||For endpoint||||<.001
73988061|NCT01222533|147521464|NON_INFERIORITY_OR_EQUIVALENCE|The standard bioequivalence range of 80 to 125% was pre-specified for Cmax,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|80.66|STANDARD_DEVIATION|43.4||0.4423||90.0|73.49|88.52||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.|||88.52|73.49|0.4423
73875616|NCT04037891|147293318|SUPERIORITY||Difference of percentage of participants|16.7|||||TWO_SIDED|95.0|-53.57|72.99||||||||72.99|-53.57|
73875617|NCT04037891|147293318|SUPERIORITY||Difference of percentage of participants|33.3|||||TWO_SIDED|95.0|-25.45|78.39||||||Comparison of incidence of ocular TEAE in all patients receiving rVA576 (part 1 and 2) vs placebo||78.39|-25.45|
73988062|NCT01222533|147521465|NON_INFERIORITY_OR_EQUIVALENCE|The standard bioequivalence range of 80 to 125% was pre-specified for AUC0-6,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|75.99|STANDARD_DEVIATION|34.1||0.8683||90.0|70.44|81.98||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.|||81.98|70.44|0.8683
73875618|NCT04491136|147293329|OTHER||||||>|0.9999|||||||McNemar|||At least one SVT occurred||||>0.9999
73875619|NCT04491136|147293329|OTHER|||||||0.7905|||||||McNemar|||At least one NSVT occurred||||0.7905
73875620|NCT04491136|147293329|OTHER|||||||0.625|||||||McNemar|||At least one PVC occurred||||0.6250
73988063|NCT01222533|147521466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.06|0.114|||||Tio R1.25-Placebo|||0.114|0.060|
73988064|NCT01222533|147521466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001||95.0|0.074|0.128|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.128|0.074|<0.0001
73988065|NCT01222533|147521466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001||95.0|0.094|0.148|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.148|0.094|<0.0001
73988066|NCT01222533|147521467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.012||||95.0|0.141|0.189|||||Tio R1.25-Placebo.|||0.189|0.141|
73988067|NCT01222533|147521467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.161|0.209|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.209|0.161|<0.0001
73988068|NCT01222533|147521467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.167|0.216|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.216|0.167|<0.0001
73988069|NCT01222533|147521468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.013||||95.0|0.13|0.18|||||Tio R1.25-Placebo|||0.180|0.130|
73988070|NCT01222533|147521468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.155|0.205|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.205|0.155|<0.0001
73988071|NCT01222533|147521468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.162|0.211|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.211|0.162|<0.0001
73988072|NCT01222533|147521469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.028||||95.0|0.083|0.194|||||Tio R1.25-Placebo|||0.194|0.083|
73988073|NCT01222533|147521469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.133|0.244|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.244|0.133|<0.0001
73988074|NCT01222533|147521469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.18|0.292|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.292|0.180|<0.0001
73988075|NCT01222533|147521470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.022||||95.0|0.241|0.326|||||Tio R1.25-Placebo|||0.326|0.241|
73875621|NCT04491136|147293331|OTHER||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.653||0.0008|TWO_SIDED|95.0|1.11|3.7|||Wilcoxon signed-rank|||||3.70|1.11|0.0008
73875622|NCT04491136|147293332|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.028||0.5733|TWO_SIDED|95.0|-0.07|0.04|||Ridit analysis|||||0.04|-0.07|0.5733
73875623|NCT04491136|147293333|OTHER||Mean Difference (Final Values)|-231.46|STANDARD_ERROR_OF_MEAN|93.03||0.0006|TWO_SIDED|95.0|-415.9|-47.02|||Wilcoxon signed rank test|||||-47.02|-415.90|0.0006
73875624|NCT04491136|147293335|OTHER||||||>|0.9999|||||||McNemar|||Occurrence of at least one shock||||>0.9999
74089814|NCT00262041|147732526|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup Y compared with that of MenACWY PS vaccine.||||<0.001
73875625|NCT04491136|147293335|OTHER|||||||0.0654|||||||McNemar|||Occurrence of at least one ATP event||||0.0654
73988076|NCT01222533|147521470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.319|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.276|0.362|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.362|0.276|<0.0001
73988077|NCT01222533|147521470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.335|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.292|0.378|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.378|0.292|<0.0001
73988078|NCT01222533|147521471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.023||||95.0|0.236|0.325|||||Tio R1.25-Placebo|||0.325|0.236|
73988079|NCT01222533|147521471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.324|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.279|0.369|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.369|0.279|<0.0001
73988080|NCT01222533|147521471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.339|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.294|0.384|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.384|0.294|<0.0001
73988081|NCT00460564|147521498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.83|||<|0.001||95.0|-10.567|-3.093|||t-test, 2 sided|||||-3.093|-10.567|<0.001
73988082|NCT04349644|147521546|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent vari- ables.||||||0.016|||||||ANCOVA|Posttest ANCOVA controlling for pretest values.||||||0.016
73988083|NCT04349644|147521546|OTHER|"A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each depen- dent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate.~Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables."||||||0.288|||||||ANCOVA|Follow-up ANCOVA while controlling Pretest.||||||0.288
73988084|NCT04349644|147521547|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.932|||||||ANCOVA|Posttest ANCOVA controlling pretest value for CASS Vocal Expressiveness.||||||0.932
73988085|NCT04349644|147521547|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.221|||||||ANCOVA|Posttest ANCOVA controlling for pretest for CASS Quality of Rapport.||||||0.221
73988086|NCT04349644|147521547|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.873|||||||ANCOVA|Follow-up ANCOVA controlling for pretest Vocal Expressiveness.||||||0.873
73988087|NCT04349644|147521547|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.512|||||||ANCOVA|Follow-up ANCOVA controlling for pretest Quality of Rapport.||||||0.512
73988088|NCT04349644|147521548|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.05|||||||ANCOVA|Posttest ANCOVA controlling for Pretest.||||||0.05
73988089|NCT04349644|147521548|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.393|||||||ANCOVA|Follow-up ANCOVA controlling for Pretest.||||||0.393
73988090|NCT04349644|147521549|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables||||||0.917|||||||ANCOVA|Posttest ANCOVA controlling for pretest values.||||||0.917
73988091|NCT04349644|147521549|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables||||||0.963|||||||ANCOVA|Follow-up ANCOVA while controlling for pretest.||||||0.963
73875626|NCT04437485|147293359|SUPERIORITY|||||||0.64|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.64
73875627|NCT04437485|147293360|SUPERIORITY|||||||0.046|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.046
73988092|NCT00225277|147521600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.886||||0.002||95.0|-1.448|-0.325|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way analysis of covariance (ANCOVA), treatment and center effects with baseline value as covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.||-0.3250|-1.4480|0.002
73988093|NCT00225277|147521601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.048||||0.064||95.0|-8.3336|0.2374|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way ANCOVA, treatment and center effects with baseline value as covariate. LS mean of the treatment difference reported.||0.2374|-8.3336|0.064
73988094|NCT00225277|147521602|SUPERIORITY_OR_OTHER|||||||0.744||||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.744
73988095|NCT00225277|147521603|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.883
73988096|NCT00225277|147521604|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.663
73988097|NCT01182103|147521708|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73988098|NCT01182103|147521709|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73988099|NCT01182103|147521710|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
73988100|NCT03455218|147521715|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
73988101|NCT03455218|147521717|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
73988102|NCT03455218|147521718|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
73988103|NCT03455218|147521719|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
73988104|NCT03455218|147521720|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73988105|NCT03455218|147521721|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
73988106|NCT03455218|147521722|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
73988107|NCT03455218|147521724|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
73988108|NCT03455218|147521725|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
73988109|NCT03455218|147521726|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
73988110|NCT03455218|147521727|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
73988111|NCT03455218|147521728|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
73988112|NCT03455218|147521729|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
73988113|NCT03455218|147521730|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
73988114|NCT00527514|147521736|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.||||<0.0001
73988115|NCT00527514|147521737|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||Statistical analysis parameters apply to both the daytime and nighttime rows.||||<0.0001
73988116|NCT00527514|147521738|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
73988117|NCT00527514|147521739|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||<0.0001
73988118|NCT00527514|147521740|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
73988119|NCT00527514|147521741|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||<0.0001
73988120|NCT00812838|147521744|SUPERIORITY|||||||0.5154||||||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.|t-test, 2 sided|||||||0.5154
73988121|NCT00812838|147521745|SUPERIORITY|||||||0.3009||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||"This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.~This analysis pertains to both categories"||||0.3009
73988122|NCT00812838|147521746|SUPERIORITY|||||||0.0166||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||0.0166
73988123|NCT00812838|147521747|SUPERIORITY|||||||0.8566||||||Threshold for statistical significance was \<0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||.8566
73988124|NCT00812838|147521748|SUPERIORITY|||||||0.0286||||||Threshold for statistical significance is \<0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||0.0286
73988125|NCT02341599|147521821|OTHER|LS mean ratio of Group B/Group A|LS mean ratio|1.29|||||TWO_SIDED|90.0|1.06|1.58|||||LS mean ratio was calculated from analysis of variance (ANOVA) model.|||1.58|1.06|
73988126|NCT02341599|147521821|OTHER|LS mean ratio of Group C/Group A|LS mean ratio|1.08|||||TWO_SIDED|90.0|0.889|1.32|||||LS mean ratio was calculated from ANOVA model.|||1.32|0.889|
73988127|NCT02341599|147521821|OTHER|LS mean ratio of Group D/Group A|LS mean ratio|2.51|||||TWO_SIDED|90.0|2.06|3.06|||||LS mean ratio was calculated from ANOVA model.|||3.06|2.06|
73988128|NCT02341599|147521821|OTHER|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.989|||||TWO_SIDED|90.0|0.806|1.21|||||LS mean ratio was calculated from ANOVA model.|||1.21|0.806|
73988129|NCT02341599|147521821|OTHER|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|3.27|||||TWO_SIDED|90.0|2.67|4.02|||||LS mean ratio was calculated from ANOVA model.|||4.02|2.67|
73988130|NCT02341599|147521821|OTHER|LS mean ratio of Group E: Period 1/Group E: Period 2|LS mean ratio|0.299|||||TWO_SIDED|90.0|0.236|0.378|||||LS mean ratio was calculated from ANOVA model.|||0.378|0.236|
73988131|NCT02341599|147521822|OTHER|LS mean ratio of Group B/Group A|LS mean ratio|1.04|||||TWO_SIDED|90.0|0.846|1.27|||||LS mean ratio was calculated from ANOVA model.|||1.27|0.846|
73988132|NCT02341599|147521822|OTHER|LS mean ratio of Group C/Group A|LS mean ratio|0.524|||||TWO_SIDED|90.0|0.428|0.641|||||LS mean ratio was calculated from ANOVA model.|||0.641|0.428|
73988133|NCT02341599|147521822|OTHER|LS mean ratio of Group D/Group A|LS mean ratio|0.678|||||TWO_SIDED|90.0|0.554|0.831|||||LS mean ratio was calculated from ANOVA model.|||0.831|0.554|
73988134|NCT02341599|147521822|OTHER|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.273|||||TWO_SIDED|90.0|0.221|0.336|||||LS mean ratio was calculated from ANOVA model.|||0.336|0.221|
73988135|NCT02341599|147521822|OTHER|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|0.326|||||TWO_SIDED|90.0|0.265|0.402|||||LS mean ratio was calculated from ANOVA model.|||0.402|0.265|
73988136|NCT02341599|147521822|OTHER|LS mean ratio of Group E: Period 2/Group E: Period 1|LS mean ratio|0.808|||||TWO_SIDED|90.0|0.65|1.0|||||LS mean ratio was calculated from ANOVA model.|||1.00|0.650|
73988137|NCT02970305|147521831|SUPERIORITY||Difference in MMRM LSMs|-1.9|STANDARD_ERROR_OF_MEAN|0.95||0.0434|TWO_SIDED|95.0|-3.8|-0.1|||Mixed-effects model for repeated measure|||||-0.1|-3.8|0.0434
73988138|NCT00983892|147521844|SUPERIORITY_OR_OTHER||Slope|-1.56||||0.03|TWO_SIDED|95.0|-2.97|-0.15|||GEE|Adjusting for baseline symptom severity, caregiver type, week number, and cancer site.||||-0.15|-2.97|0.030
73988139|NCT04522778|147521866|OTHER|||||||0.029|||||||t-test, 1 sided|||A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)||||.029
73988140|NCT04522778|147521867|SUPERIORITY|||||||0.35|||||||t-test, 1 sided|||A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)||||.35
73988141|NCT04522778|147521868|SUPERIORITY|||||||0.334|||||||t-test, 1 sided|||||||.334
74034986|NCT00755846|147622411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8|STANDARD_ERROR_OF_MEAN|8.68||0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.009
73875628|NCT04437485|147293361|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.09
73988142|NCT04522778|147521869|SUPERIORITY||Odds Ratio (OR)|38.26|STANDARD_ERROR_OF_MEAN|50.195||0.005|TWO_SIDED|95.0|2.926154|500.4402|||Chi-squared|||||500.4402|2.926154|.005
73988143|NCT04522778|147521870|SUPERIORITY||Odds Ratio (OR)|30.975|STANDARD_ERROR_OF_MEAN|35.73483||0.003|TWO_SIDED|95.0|3.22|297.17|||Chi-squared|||||297.17|3.22|.003
73988144|NCT04522778|147521871|SUPERIORITY||Odds Ratio (OR)|27.36|STANDARD_ERROR_OF_MEAN|31.72||0.004|TWO_SIDED|95.0|2.82|265.45|||Chi-squared|||||265.45|2.82|.004
73988145|NCT04522778|147521872|SUPERIORITY||Odds Ratio (OR)|10.93|STANDARD_ERROR_OF_MEAN|10.345||0.011|TWO_SIDED|95.0|1.71|69.82|||Chi-squared|||||69.82|1.71|.011
73988146|NCT04522778|147521873|SUPERIORITY||Odds Ratio (OR)|0.298|STANDARD_ERROR_OF_MEAN|0.2189||0.099|TWO_SIDED|95.0|0.0706|1.258|||Chi-squared|||||1.258|.0706|.099
73988147|NCT04522778|147521874|SUPERIORITY||Odds Ratio (OR)|1.201|STANDARD_ERROR_OF_MEAN|1.201||0.312|TWO_SIDED|95.0|0.549|6.562|||Chi-squared|||||6.562|.549|.312
73988148|NCT04522778|147521875|SUPERIORITY||Odds Ratio (OR)|1.519|STANDARD_ERROR_OF_MEAN|2.022||0.753|TWO_SIDED|95.0|0.112|20.623|||Chi-squared|||||20.623|.112|.753
73988149|NCT04522778|147521876|SUPERIORITY||Odds Ratio (OR)|0.321|STANDARD_ERROR_OF_MEAN|0.257||0.156|TWO_SIDED|95.0|0.067|1.541|||Chi-squared|||||1.541|.067|.156
73988150|NCT04522778|147521877|SUPERIORITY||Odds Ratio (OR)|0.458|STANDARD_ERROR_OF_MEAN|0.358||0.318|TWO_SIDED|95.0|0.099|2.122|||Chi-squared|||||2.122|.099|.318
73988151|NCT04522778|147521878|SUPERIORITY||Odds Ratio (OR)|0.449|STANDARD_ERROR_OF_MEAN|0.882||0.684|TWO_SIDED|95.0|0.009|21.003|||Chi-squared|||||21.003|.009|.684
73988152|NCT04522778|147521879|SUPERIORITY||Odds Ratio (OR)|2.335|STANDARD_ERROR_OF_MEAN|2.683||0.46|TWO_SIDED|95.0|0.246|22.194|||Chi-squared|||||22.194|.246|.460
73988153|NCT04522778|147521880|SUPERIORITY||Odds Ratio (OR)|2.299|STANDARD_ERROR_OF_MEAN|2.47293||0.439|TWO_SIDED|95.0|0.279|18.927|||Chi-squared|||||18.927|.279|.439
73988154|NCT04522778|147521881|SUPERIORITY||Odds Ratio (OR)|1.634|STANDARD_ERROR_OF_MEAN|2.187||0.714|TWO_SIDED|95.0|0.119|22.514|||Chi-squared|||||22.514|.119|.714
73988155|NCT04522778|147521882|SUPERIORITY||Odds Ratio (OR)|0.379|STANDARD_ERROR_OF_MEAN|0.448||0.412|TWO_SIDED|95.0|0.037|3.842|||Chi-squared|||||3.842|.037|.412
73988156|NCT04522778|147521883|SUPERIORITY||Odds Ratio (OR)|0.579|STANDARD_ERROR_OF_MEAN|0.539||0.558|TWO_SIDED|95.0|0.094|3.582|||Chi-squared|||||3.582|.094|.558
73988157|NCT04522778|147521884|SUPERIORITY||Odds Ratio (OR)|0.688|STANDARD_ERROR_OF_MEAN|0.609||0.673|TWO_SIDED|95.0|0.121|3.9|||Chi-squared|||||3.90|.121|.673
73988158|NCT04522778|147521885|SUPERIORITY||Odds Ratio (OR)|0.674|STANDARD_ERROR_OF_MEAN|0.438||0.544|TWO_SIDED|95.0|0.189|2.406|||Chi-squared|||||2.406|.189|.544
73988159|NCT04522778|147521886|SUPERIORITY||Odds Ratio (OR)|1.88|STANDARD_ERROR_OF_MEAN|1.631||0.464|TWO_SIDED|95.0|0.345|10.278|||Chi-squared|||||10.278|.345|.464
73988160|NCT04522778|147521887|SUPERIORITY||Odds Ratio (OR)|5.595|STANDARD_ERROR_OF_MEAN|5.675||0.09|TWO_SIDED|95.0|0.766|40.854|||Chi-squared|||||40.854|.766|.090
73988161|NCT04522778|147521888|SUPERIORITY||Odds Ratio (OR)|0.987|STANDARD_ERROR_OF_MEAN|1.119||0.991|TWO_SIDED|95.0|0.107|9.114|||Chi-squared|||||9.114|.107|.991
73988162|NCT04522778|147521889|SUPERIORITY||Odds Ratio (OR)|4.239|STANDARD_ERROR_OF_MEAN|5.027||0.223|TWO_SIDED|95.0|0.415|43.326|||Chi-squared|||||43.326|.415|.223
73988163|NCT04522778|147521890|SUPERIORITY||Odds Ratio (OR)|2.199|STANDARD_ERROR_OF_MEAN|2.496||0.488|TWO_SIDED|95.0|0.238|20.348|||Chi-squared|||||20.348|.238|.488
73988164|NCT04522778|147521891|SUPERIORITY||Odds Ratio (OR)|0.177|STANDARD_ERROR_OF_MEAN|0.129||0.018|TWO_SIDED|95.0|0.0424|0.743|||Chi-squared|||||.743|.0424|.018
73988165|NCT04522778|147521892|SUPERIORITY||Odds Ratio (OR)|3.688|STANDARD_ERROR_OF_MEAN|4.358||0.269|TWO_SIDED|95.0|0.364|37.379|||Chi-squared|||||37.379|.364|.269
73988166|NCT04522778|147521893|SUPERIORITY||Odds Ratio (OR)|4.251|STANDARD_ERROR_OF_MEAN|3.829||0.108|TWO_SIDED|95.0|0.728|24.84|||Chi-squared|||||24.84|.728|.108
74089815|NCT00262041|147732526|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup Y compared with that of MenACWY PS vaccine.||||<0.001
74089816|NCT01421342|147732531|SUPERIORITY||Odds Ratio (OR)|1.31||||0.076|TWO_SIDED|95.0|0.97|1.75||Co-primary hypothesis: After ordering results from largest p-value to smallest (Hochberg approach) the comparison of Augmenting Antidepressant+Bupropion with Switching to Bupropion-SR was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR|||1.75|0.97|0.076
74089817|NCT01421342|147732531|SUPERIORITY||Odds Ratio (OR)|1.42||||0.018|TWO_SIDED|95.0|1.06|1.89||Co-primary hypothesis: Second ordered test after ordering largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|Co-primary hypothesis: After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||1.89|1.06|0.018
73988167|NCT04522778|147521894|SUPERIORITY||Odds Ratio (OR)|3.658|STANDARD_ERROR_OF_MEAN|2.99||0.113|TWO_SIDED|95.0|0.737|18.157|||Chi-squared|||||18.157|.737|.113
73988168|NCT04522778|147521895|SUPERIORITY||Odds Ratio (OR)|2.495|STANDARD_ERROR_OF_MEAN|1.156||0.049|TWO_SIDED|95.0|1.004|6.202|||Chi-squared|||||6.202|1.004|.049
73988169|NCT02920021|147521897|SUPERIORITY||Least Squares (LS) Mean Difference|60.046|STANDARD_ERROR_OF_MEAN|79.918||0.463|TWO_SIDED|95.0|-108.566|228.657|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline value as covariate.|Treatment Difference = Etokimab - Placebo|||228.657|-108.566|0.463
73988170|NCT02920021|147521898|SUPERIORITY||LS Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.016||0.962|TWO_SIDED|95.0|-0.031|0.032|||ANCOVA|ANCOVA model with treatment as fixed effect and baseline value as covariate.|Treatment Difference = Etokimab - Placebo|||0.032|-0.031|0.962
73988171|NCT05400226|147521910|OTHER|Summary statistics of quantitative data, one-sided exact binomial test for null hypothesis, Clopper-Pearson method for 95% exact confidence intervals|Proportion|0.425|||<|0.0001|TWO_SIDED|95.0|0.27|0.591|||Exact Binomial Test||The Parameter Dispersion Value is the asymptotic standard error of the proportion.|Single arm open-label||0.591|0.270|< .0001
73988172|NCT05400226|147521911|OTHER||Proportion|0.85|||||TWO_SIDED|95.0|0.675|0.939||||||||0.939|0.675|
73988173|NCT05400226|147521912|OTHER||Proportion|0.455|||||TWO_SIDED|95.0|0.202|0.733||||||||0.733|0.202|
73988174|NCT05400226|147521913|OTHER||Proportion|0.333|||||TWO_SIDED|95.0|0.126|0.633||||||||0.633|0.126|
73988175|NCT05400226|147521914|OTHER||Proportion|0.773|||||TWO_SIDED|95.0|0.65|0.862||||||||0.862|0.650|
73988176|NCT00312845|147521916|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Log Rank|||||||0.039
73988177|NCT00312845|147521917|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73988178|NCT01355471|147521935|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||GEE: Logit link function|Generalized Estimation Equation (GEE) methods with Logit link function and marginal expectation model.||||||<0.001
73988179|NCT01123512|147521942|NON_INFERIORITY_OR_EQUIVALENCE|"Pr( Pt - Pc \> -12.5% \| data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt - Pc \> -12.5% \| data)\> 96.6%."|% Probability of Equivalence = 99.92|99.92|||||TWO_SIDED|||||"Pr( Pt - Pc \> -12.5% \| data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt - Pc \> -12.5% \| data)\> 96.6%."|Bayesian test of proportions|||||||
73988180|NCT01494298|147521943|SUPERIORITY_OR_OTHER||||||=|0.002||95.0||||The control group average age was 6 years lower(P=0.001). Results were adjusted via a logistic regression and presented as age-adjusted means and SE. The unadjusted differences had similar results.|t-test, 2 sided|||Hypothesis - There will be differences in ApoB between AA with T2DM and those without. To achieve a power of 80%, 48 subjects in each group were needed to detect 15 mg/dL difference in ApoB levels, assuming a standard deviation of 26 mg/dL if alpha was set at 0.05. Continuous data were compared using a Students t-test and categorical data were compared using test.||||=0.002
73988181|NCT01494298|147521945|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||t-test, 2 sided|||||||0.84
73988182|NCT00006436|147521959|SUPERIORITY|||||||0.1|||||||Two-tailed log rank test||||Compared the PFS of interim PET positive participants to the PFS of interim PET negative.|||0.10
73988183|NCT00562484|147521983|SUPERIORITY_OR_OTHER||Vaccine Efficacy|42.0|||||TWO_SIDED|95.0|30.0|52.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)||52|30|
73988184|NCT00562484|147521984|SUPERIORITY_OR_OTHER||Vaccine efficacy|60.0|||||TWO_SIDED|95.0|44.0|72.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)||72|44|
73988185|NCT01929876|147522018|SUPERIORITY_OR_OTHER||Ratio of least squares means|316.6|||||TWO_SIDED|90.0|268.1|374.0|||||LS means from analysis of variance (ANOVA), calculated by transforming the natural log means back to the linear scale (that is, geometric LS mean).|Ratio of Least squares (LS) means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent).||374.0|268.1|
73988186|NCT01929876|147522019|SUPERIORITY_OR_OTHER||Ratio of LS means|672.3|||||TWO_SIDED|90.0|563.7|801.9|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.|Only participants with PK parameter data from both Period 1 Day 1 and Period 2 Day 4 (n=11) were included for statistical analyses.||801.9|563.7|
73988187|NCT01929876|147522021|SUPERIORITY_OR_OTHER||Ratio of LS means|583.9|||||TWO_SIDED|90.0|488.2|698.2|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.|||698.2|488.2|
73988188|NCT02412111|147522052|SUPERIORITY||Least Square (LS) mean difference|0.3|||=|0.5846|TWO_SIDED|95.0|-0.8|1.4|||Mixed Model for Repeated Measures (MMRM)|||||1.4|-0.8|= 0.5846
73988189|NCT02412111|147522053|SUPERIORITY||Least square mean difference|0.8|||=|0.386|TWO_SIDED|95.0|-1.0|2.6|||Mixed models Repeated Measures (MMRM)|||||2.6|-1.0|= 0.3860
73988190|NCT02412111|147522054|SUPERIORITY||Least square mean difference|2.8|||=|0.1236|TWO_SIDED|95.0|-0.8|6.4|||Mixed models Repeated Measures (MMRM)|||||6.4|-0.8|= 0.1236
73988191|NCT02412111|147522055|SUPERIORITY||Least square mean difference|-5.8|||=|0.0216|TWO_SIDED|95.0|-10.7|-0.9|||Mixed models Repeated Measures (MMRM)|||||-0.9|-10.7|= 0.0216
73988192|NCT02705625|147522063|SUPERIORITY|"For the primary endpoint, the Type I error for the tests of the two doses was protected by performing a fixed-sequence multiple-testing procedure in the following order:~Step 1: 200 mg versus placebo Step 2: 100 mg versus placebo The second step was only considered as confirmatory provided the previous step was significant at a one-sided 5%-level (p\<0.05).~If the previous step was not significant, the analysis of the following step was considered descriptive."|Mean Difference (Final Values)|-0.0761||||0.4055|TWO_SIDED|95.0|-0.703|0.55||The p-values reported is from Step 1 (comparing 200 mg versus placebo). The corresponding p-value from Step 2 (comparing 100 mg versus placebo) was 0.1458.|Mixed Models Analysis|||A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment by time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline NRS was included as a covariate for adjustment. An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model.||0.55|-0.703|0.4055
73988193|NCT02705625|147522064|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-14.7||||0.0036|TWO_SIDED|95.0|-25.3|-4.02||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-4.02|-25.3|0.0036
73988194|NCT02705625|147522064|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-15.4||||0.0023|TWO_SIDED|95.0|-26.0|-4.83||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-4.83|-26|0.0023
73988195|NCT02705625|147522065|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0436||||0.1253|TWO_SIDED|95.0|-0.031|0.118||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||0.118|-0.031|0.1253
73988196|NCT02705625|147522065|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0761||||0.0225|TWO_SIDED|95.0|0.00173|0.15||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||0.15|0.00173|0.0225
73988197|NCT02705625|147522066|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-1.77||||0.2887|TWO_SIDED|95.0|-8.02|4.48||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time,baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.48|-8.02|0.2887
74089818|NCT01421342|147732531|SUPERIORITY||Odds Ratio (OR)|1.11||||0.46|TWO_SIDED|95.0|0.84|1.48||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR was evaluated at the 0.05 significance level.|Regression, Logistic||Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|If either if the first two hypothesis tests for the co-primary hypotheses were significant, perform the test of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.||1.48|0.84|0.46
73988198|NCT02705625|147522066|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-4.55||||0.0753|TWO_SIDED|95.0|-10.8|1.67||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||1.67|-10.8|0.0753
73988199|NCT02705625|147522067|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-1.84||||0.2898|TWO_SIDED|95.0|-8.38|4.7||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.7|-8.38|0.2898
73988200|NCT02705625|147522067|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-3.78||||0.1262|TWO_SIDED|95.0|-10.3|2.72||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||2.72|-10.3|0.1262
73988201|NCT02705625|147522068|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-3.07||||0.2|TWO_SIDED|95.0|-10.2|4.1||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.1|-10.2|0.2
73988202|NCT02705625|147522068|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-4.95||||0.0861|TWO_SIDED|95.0|-12.1|2.17||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||2.17|-12.1|0.0861
73988203|NCT02705625|147522069|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.254|||<|0.0001|TWO_SIDED|95.0|-0.302|-0.206||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-0.206|-0.302|<0.0001
74039593|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0003|TWO_SIDED|95.0|1.27|2.24|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.24|1.27|0.0003
73988204|NCT02705625|147522069|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.145|||<|0.0001|TWO_SIDED|95.0|-0.193|-0.0983||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-0.0983|-0.193|<0.0001
74039594|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2561|TWO_SIDED|95.0|0.9|1.51|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.90|0.2561
73988205|NCT02705625|147522070|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-270.0|||<|0.0001|TWO_SIDED|95.0|-339.0|-201.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-201|-339|<0.0001
73988206|NCT02705625|147522070|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-193.0|||<|0.0001|TWO_SIDED|95.0|-262.0|-124.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by- time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-124|-262|<0.0001
73988207|NCT03677245|147522097|OTHER|Wilcoxon signed ranks test used to compared pre-intervention to post-intervention means of the Pediatric Balance Scale. No power calculation performed or utilized.|Mean Difference (Final Values)|1.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73988208|NCT01850823|147522141|EQUIVALENCE|Equivalence based on Test/Reference Ratio and 90% confidence interval (as per OGD guidance)|Ratio Test/Reference LS Mean|114.723|||||TWO_SIDED|90.0|99.077|134.286||||||Conducted on Per Protocol Population||134.286|99.077|
73988209|NCT01850823|147522142|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.||||<0.0001
73988210|NCT01850823|147522142|SUPERIORITY|||||||0.0002|||||||ANCOVA|||The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.||||0.0002
73988211|NCT01751165|147522144|NON_INFERIORITY_OR_EQUIVALENCE|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.98|1.39|||ANCOVA|||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,6-month schedule compared to a 0,2-month schedule.||1.39|0.98|
73988212|NCT01751165|147522144|NON_INFERIORITY_OR_EQUIVALENCE|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.19|||||TWO_SIDED|97.5|0.93|1.53|||ANCOVA|||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,12-month schedule compared to a 0,2-month schedule.||1.53|0.93|
73988213|NCT00307164|147522167|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||95.0|||||Stratified Wilcoxon rank-sum test|Treatment groups were compared for change in limb fat using a two-sided stratified Wilcoxon rank-sum test (stratified by ARV used)||||||0.64
73988214|NCT00307164|147522168|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Log Rank|||||||0.17
73988215|NCT00307164|147522170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.25
74089819|NCT01421342|147732532|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.7|TWO_SIDED|95.0|0.78|2.39|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR|||2.39|0.78|0.70
74089820|NCT01421342|147732532|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.68|TWO_SIDED|95.0|0.65|1.94|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|||1.94|0.65|0.68
73988216|NCT00307164|147522172|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.88
73988217|NCT00307164|147522173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.60
73988218|NCT00307164|147522174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.13
73988219|NCT00307164|147522175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.17
73988220|NCT00307164|147522176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.034
73988221|NCT00307164|147522177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.76
73988222|NCT00307164|147522178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.10
73988223|NCT00307164|147522179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.43||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.43
73988224|NCT00307164|147522180|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.17
73988225|NCT00307164|147522181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.80
73988226|NCT00307164|147522182|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.42
73988227|NCT01049984|147522197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.012|TWO_SIDED|95.0|-4.3|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||-0.5|-4.3|0.012
73988228|NCT01049984|147522198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.301|TWO_SIDED|95.0|-1.1|0.3||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||0.3|-1.1|0.301
74034987|NCT00755846|147622411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.4|STANDARD_ERROR_OF_MEAN|8.38|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
73988229|NCT01049984|147522199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.007|TWO_SIDED|95.0|-3.1|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||-0.5|-3.1|0.007
73988230|NCT01049984|147522200|SUPERIORITY_OR_OTHER|||||||0.255||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.||||||0.255
73988231|NCT01049984|147522201|SUPERIORITY_OR_OTHER|||||||0.996||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.||||||0.996
73988232|NCT01049984|147522202|SUPERIORITY_OR_OTHER|||||||0.967||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment, pooled center, and baseline value as strata.||||||0.967
73988233|NCT00014222|147522223|SUPERIORITY|||||||0.0007|||||||Log Rank|||||||0.0007
73988234|NCT00014222|147522224|SUPERIORITY|||||||0.084|||||||Log Rank|||||||0.084
73988235|NCT02287883|147522225|OTHER|Clustered two-sample t-test||||||0.8|||||||t-test, 2 sided|||||||0.80
73988236|NCT02287883|147522226|OTHER|Clustered two-sample t-test||||||0.48|||||||t-test, 2 sided|||||||0.48
74039595|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2358|TWO_SIDED|95.0|0.9|1.51|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.90|0.2358
74039596|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.45||||0.004|TWO_SIDED|95.0|1.13|1.87|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.87|1.13|0.0040
74039597|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0723|TWO_SIDED|95.0|0.97|2.02|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.02|0.97|0.0723
74039598|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|2.06|||<|0.0001|TWO_SIDED|95.0|1.45|2.92|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.92|1.45|<.0001
73875629|NCT02719171|147293362|OTHER||Mean Difference (Final Values)|24.0||||0.007|TWO_SIDED|90.0|9.3|38.7|||Cochran-Mantel-Haenszel|||The 90% confidence interval (CI) for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior tumor necrosis factor inhibitor (TNFi) use and concurrent methotrexate use.||38.7|9.3|0.007
73988237|NCT02287883|147522227|OTHER|Clustered two-sample t-test||||||0.05|||||||t-test, 2 sided|||||||0.05
73988238|NCT00802438|147522228|OTHER||||||<|0.0001||||||A two-sided p-value\<0.05 was considered significant. Analyses were conducted using SAS version 9.4 (SAS Institute, Cary, NC.).|t-test, 2 sided|||Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.||||<0.0001
73988239|NCT00802438|147522229|OTHER|Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.||||||0.01|||||||t-test, 2 sided|||||||0.01
73988240|NCT00496834|147522249|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -1.5m/s|Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|1.43|||TWO_SIDED|95.0|-0.83|0.01|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94).||0.01|-0.83|
73988241|NCT00496834|147522250|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin=-1.5m/s|Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|1.4|||TWO_SIDED|95.0|-0.86|0.15|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.||0.15|-0.86|
73988242|NCT00496834|147522251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9032||95.0||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test.||||||0.9032
73988243|NCT00496834|147522252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6574||95.0||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test||||||0.6574
73988244|NCT01227928|147522253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984|||||TWO_SIDED|95.0|0.595|1.626|||||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the stratification factor of first-line treatment outcome.|||1.626|0.595|
74034988|NCT00755846|147622411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|8.57||0.057||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.057
74034989|NCT00755846|147622411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|8.56||0.156||95.0||||No multiplicity adjustments|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.156
74034990|NCT00755846|147622412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|STANDARD_ERROR_OF_MEAN|7.05|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between all doses of alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
74034991|NCT00755846|147622412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.4|STANDARD_ERROR_OF_MEAN|8.91||0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.001
73875630|NCT02719171|147293363|OTHER||Mean Difference (Final Values)|12.0||||0.074|TWO_SIDED|90.0|1.0|23.0|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||23.0|1.0|0.074
73988245|NCT01227928|147522254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.811||||0.5901|TWO_SIDED|95.0|0.376|1.751|||Log Rank||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the three stratification factors.|||1.751|0.376|0.5901
73988246|NCT01042145|147522268|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
73988247|NCT01042145|147522269|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.63
73988248|NCT01042145|147522271|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.51
74034992|NCT00755846|147622412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.6|STANDARD_ERROR_OF_MEAN|9.2||0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.008
74034993|NCT00755846|147622412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|STANDARD_ERROR_OF_MEAN|8.88|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
74039599|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0653|TWO_SIDED|95.0|0.98|1.94|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.94|0.98|0.0653
74039600|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9177|TWO_SIDED|95.0|0.74|1.4|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.40|0.74|0.9177
73988249|NCT01042145|147522272|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.24
73988250|NCT01042145|147522273|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
73988251|NCT02930837|147522274|SUPERIORITY||Percentage of patients|63.3|||<|0.0001|TWO_SIDED|95.0|54.42|71.42|||One-sample test||Percentage of patients with Favourable outcome|A null hypothesis of p ≤40% versus the alternative hypothesis of p \>40% was tested using a one sample test at two-sided significance level of 0.05, where p denoted the response rate in Chinese patients who were treated within 3-4.5 h after stroke onset.||71.42|54.42|<0.0001
73988252|NCT01393613|147522281|SUPERIORITY_OR_OTHER|||||||0.0093|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6. The primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) with an unstructured variance covariance structure. The model included fixed class effect terms for treatment, trial site, visit week, baseline, baseline and visit interaction and an interaction term of treatment by visit week.||||0.0093
73988253|NCT01393613|147522281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47||||0.0022|TWO_SIDED|95.0|-10.6|-2.35|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-2.35|-10.6|0.0022
73988254|NCT01393613|147522281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08||||0.1448|TWO_SIDED|95.0|-7.23|1.07|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.07|-7.23|0.1448
73988255|NCT01393613|147522281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.37||||0.1588|TWO_SIDED|95.0|-8.06|1.32|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6. MMRM analysis fixed effect of treatment, clinical visit, trial site, treatment visit interaction, Baseline value, and Baseline visit interaction as covariates.||1.32|-8.06|0.1588
73988256|NCT01393613|147522282|SUPERIORITY_OR_OTHER|||||||0.0069|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6.||||0.0069
73875631|NCT02719171|147293363|OTHER||Mean Difference (Final Values)|19.0||||0.007|TWO_SIDED|90.0|7.4|30.6|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||30.6|7.4|0.007
74034994|NCT00755846|147622412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|9.09||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.136
74034995|NCT00755846|147622412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|9.07||0.073||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.073
74034996|NCT00755846|147622413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|5.85|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
74034997|NCT00755846|147622413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.2|STANDARD_ERROR_OF_MEAN|7.37||0.01||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.010
74034998|NCT00755846|147622413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8|STANDARD_ERROR_OF_MEAN|7.71||0.002||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.002
74034999|NCT00755846|147622413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|7.33||0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.003
74039601|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0088|TWO_SIDED|95.0|1.11|2.01|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.01|1.11|0.0088
73875632|NCT02719171|147293364|OTHER||Mean Difference (Final Values)|10.3||||0.006|TWO_SIDED|90.0|4.1|16.4|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||16.4|4.1|0.006
73988257|NCT01393613|147522282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.0015|TWO_SIDED|95.0|-0.62|-0.15|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. The analysis of this key secondary endpoint was conducted if both comparisons of brexpiprazole 4 mg/day vs placebo and brexpiprazole 2 mg/day vs placebo of the primary endpoint were significant. Because only the comparison of brexpiprazole 4 mg/day vs placebo met the threshold in the primary analysis, the following analysis is not part of the formal statistical testing and is descriptive only.||-0.15|-0.62|0.0015
73988258|NCT01393613|147522282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.1269|TWO_SIDED|95.0|-0.42|-0.05|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.05|-0.42|0.1269
74089821|NCT01421342|147732532|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.87|TWO_SIDED|95.0|0.58|1.59|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||1.59|0.58|0.87
73988259|NCT01393613|147522282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4449|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.16|-0.37|0.4449
73988260|NCT01393613|147522283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.59||||0.0005|TWO_SIDED|95.0|2.02|7.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||7.17|2.02|0.0005
73988261|NCT01393613|147522283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.1286|TWO_SIDED|95.0|-0.58|4.59|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||4.59|-0.58|0.1286
73988262|NCT01393613|147522283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21||||0.0332|TWO_SIDED|95.0|0.26|6.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||6.16|0.26|0.0332
73988263|NCT01393613|147522284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.0166|TWO_SIDED|95.0|-3.08|-0.31|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.31|-3.08|0.0166
73988264|NCT01393613|147522284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.5101|TWO_SIDED|95.0|-1.86|0.93|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.93|-1.86|0.5101
73988265|NCT01393613|147522284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.3938|TWO_SIDED|95.0|-2.26|0.89|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.89|-2.26|0.3938
73988266|NCT01393613|147522285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.0231|TWO_SIDED|95.0|-2.28|-0.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.17|-2.28|0.0231
73988267|NCT01393613|147522285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.1547|TWO_SIDED|95.0|-1.83|0.29|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.29|-1.83|0.1547
73988268|NCT01393613|147522285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.2004|TWO_SIDED|95.0|-1.98|0.42|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.42|-1.98|0.2004
73988269|NCT01393613|147522286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0009|TWO_SIDED|95.0|-0.78|-0.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.20|-0.78|0.0009
73988270|NCT01393613|147522286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0422|TWO_SIDED|95.0|-0.6|-0.01|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.01|-0.60|0.0422
73988271|NCT01393613|147522286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.1358|TWO_SIDED|95.0|-0.56|0.08|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.08|-0.56|0.1358
73988272|NCT01393613|147522287|SUPERIORITY_OR_OTHER||Relative Risk|1.54||||0.0006|TWO_SIDED|95.0|1.2|2.0|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||2.00|1.20|0.0006
73988273|NCT01393613|147522287|SUPERIORITY_OR_OTHER||Relative Risk|1.22||||0.168|TWO_SIDED|95.0|0.92|1.62|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.62|0.92|0.1680
73988274|NCT01393613|147522287|SUPERIORITY_OR_OTHER||Relative Risk|1.35||||0.0433|TWO_SIDED|95.0|1.02|1.79|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.79|1.02|0.0433
73875633|NCT02719171|147293364|OTHER||Mean Difference (Final Values)|15.7|||<|0.001|TWO_SIDED|90.0|8.5|22.9|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||22.9|8.5|<0.001
73875634|NCT02719171|147293365|OTHER||Mean Difference (Final Values)|-0.8||||0.69|TWO_SIDED|90.0|-4.0|2.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||2.5|-4.0|0.690
73875635|NCT02719171|147293365|OTHER||Mean Difference (Final Values)|-2.1||||0.26|TWO_SIDED|90.0|-5.3|1.0|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.0|-5.3|0.260
73988275|NCT01393613|147522288|SUPERIORITY_OR_OTHER||Relative Risk|0.82||||0.5202|TWO_SIDED|95.0|0.44|1.51|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||1.51|0.44|0.5202
73988276|NCT01393613|147522288|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||0.9894|TWO_SIDED|95.0|0.55|1.85|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.85|0.55|0.9894
73988277|NCT01393613|147522288|SUPERIORITY_OR_OTHER||Relative Risk|0.76||||0.4586|TWO_SIDED|95.0|0.36|1.59|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.59|0.36|0.4586
73988278|NCT01393613|147522289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0029|TWO_SIDED|95.0|-2.3|-0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.48|-2.30|0.0029
73875636|NCT02719171|147293366|OTHER||Mean Difference (Final Values)|-0.3||||0.791|TWO_SIDED|90.0|-2.1|1.5|||Cochran-Mantel-Haenszel|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.5|-2.1|0.791
73875637|NCT02719171|147293366|OTHER||Mean Difference (Final Values)|-1.1||||0.32|TWO_SIDED|90.0|-2.8|0.7|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.7|-2.8|0.320
73875638|NCT02719171|147293367|OTHER||mixed model repeated measures model|-0.082||||0.341|TWO_SIDED|90.0|-0.225|0.06|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.060|-0.225|0.341
73875639|NCT02719171|147293367|OTHER||Mean Difference (Final Values)|-0.114||||0.181|TWO_SIDED|90.0|-0.254|0.027|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.027|-0.254|0.181
73988279|NCT01393613|147522289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.3559|TWO_SIDED|95.0|-1.34|0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.48|-1.34|0.3559
73988280|NCT01393613|147522289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.3646|TWO_SIDED|95.0|-1.51|0.56|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.56|-1.51|0.3646
73988281|NCT01393613|147522290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.1273|TWO_SIDED|95.0|-2.61|0.33|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||0.33|-2.61|0.1273
73988282|NCT01393613|147522290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.64|TWO_SIDED|95.0|-1.83|1.12|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.12|-1.83|0.6400
74039602|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1197|TWO_SIDED|95.0|0.89|2.83|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.83|0.89|0.1197
74039603|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0913|TWO_SIDED|95.0|0.92|2.92|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.92|0.92|0.0913
74039604|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.25||||0.4317|TWO_SIDED|95.0|0.72|2.19|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.19|0.72|0.4317
74039605|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.27||||0.3498|TWO_SIDED|95.0|0.77|2.08|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.08|0.77|0.3498
74039606|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.31||||0.2768|TWO_SIDED|95.0|0.8|2.15|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.15|0.80|0.2768
73875640|NCT02719171|147293368|OTHER||Mean Difference (Final Values)|1.7||||0.174|TWO_SIDED|90.0|-0.36|3.77|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.77|-0.36|0.174
73988283|NCT01393613|147522290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.4423|TWO_SIDED|95.0|-2.32|1.01|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.01|-2.32|0.4423
73988284|NCT01393613|147522291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0194|TWO_SIDED|95.0|-2.36|-0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.21|-2.36|0.0194
73988285|NCT01393613|147522291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.0754|TWO_SIDED|95.0|-2.06|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.10|-2.06|0.0754
73988286|NCT01393613|147522291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.108|TWO_SIDED|95.0|-2.22|0.22|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.22|-2.22|0.1080
73988287|NCT01393613|147522292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0045|TWO_SIDED|95.0|-2.34|-0.43|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.||-0.43|-2.34|0.0045
73988288|NCT01393613|147522292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.4753|TWO_SIDED|95.0|-1.31|0.61|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.61|-1.31|0.4753
73988289|NCT01393613|147522292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.115|TWO_SIDED|95.0|-1.96|0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.21|-1.96|0.1150
73988290|NCT01393613|147522293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.0021|TWO_SIDED|95.0|-2.05|-0.46|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.46|-2.05|0.0021
73988291|NCT01393613|147522293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.6792|TWO_SIDED|95.0|-0.97|0.63|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.63|-0.97|0.6792
74035000|NCT00755846|147622413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|STANDARD_ERROR_OF_MEAN|7.44||0.006||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.006
74089822|NCT01421342|147732533|SUPERIORITY||Odds Ratio (OR)|1.16||||0.28|TWO_SIDED|95.0|0.89|1.5|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.||1.50|0.89|0.28
73988292|NCT01393613|147522293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.5752|TWO_SIDED|95.0|-1.16|0.65|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.65|-1.16|0.5752
73988293|NCT01393613|147522294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.0104|TWO_SIDED|95.0|-1.51|-0.2|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.20|-1.51|0.0104
73988294|NCT01393613|147522294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0373|TWO_SIDED|95.0|-1.35|-0.04|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.04|-1.35|0.0373
73988295|NCT01393613|147522294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.089|TWO_SIDED|95.0|-1.39|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.10|-1.39|0.0890
73875641|NCT02719171|147293368|OTHER||Mean Difference (Final Values)|1.35||||0.284|TWO_SIDED|90.0|-0.73|3.44|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.44|-0.73|0.284
73988296|NCT02598934|147522370|SUPERIORITY_OR_OTHER||Difference in percentage of participants|16.9||||0.002|TWO_SIDED|95.0|6.1|27.7||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate was effective in treating osteoporosis|Chi-squared, Corrected|||||27.7|6.1|0.002
73988297|NCT02598934|147522370|SUPERIORITY_OR_OTHER||Difference in percentage of participants|14.9||||0.009|TWO_SIDED|95.0|4.0|25.8||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate reduces risk of breaking bone.|Chi-squared, Corrected|||||25.8|4.0|0.009
73988298|NCT02598934|147522370|SUPERIORITY_OR_OTHER||Difference in percentage of participants|16.9||||0.001|TWO_SIDED|95.0|6.3|27.5|||Chi-squared, Corrected|P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis or reduces risk of breaking bone.||||27.5|6.3|0.001
73988299|NCT02598934|147522370|SUPERIORITY_OR_OTHER||Difference in percentage of participants|14.9||||0.01|TWO_SIDED|95.0|3.9|25.9||P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis and reduces risk of breaking bone.|Chi-squared, Corrected|||||25.9|3.9|0.010
73988300|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The first blood samples from both groups were collected before cardiopulmonary bypass.||||0.377
73988301|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups on arrival of intensive care unit.||||0.051
73988302|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.282|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples from both groups were collected 24 hours after Operation.||||0.282
73988303|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. These blood samples were collected 48 hours after cardiopulmonary Bypass.||||0.277
73988304|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups 72 hours after cardiopulmonary bypass.||||0.308
73875642|NCT02719171|147293369|OTHER||Mean Difference (Final Values)|0.59||||0.718|TWO_SIDED|90.0|-2.12|3.3|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.30|-2.12|0.718
73988305|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.211|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.||||0.211
73988306|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected on arrival of intensive care unit.||||0.004
73988307|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 24 hours after operation.||||0.221
73988308|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 48 hours after operation.||||0.796
73988309|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.463|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 72 hours after operation.||||0.463
73988310|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.||||0.118
73988311|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected on arrival of intensive care unit.||||0.0001
73988312|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected one hour after cardiopulmonary bypass.||||0.0001
74039607|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0101|TWO_SIDED|95.0|1.09|1.92|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.92|1.09|0.0101
73988313|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected four hours after cardiopulmonary bypass.||||0.0001
73988314|NCT02672514|147522371|SUPERIORITY_OR_OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected 48 hours after cardiopulmonary bypass.||||0.171
73988315|NCT02188784|147522373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.03||||0.457|TWO_SIDED|95.0|-34.38|76.43|||Regression, Linear|||||76.43|-34.38|0.4570
73988316|NCT02188784|147522374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77||||0.9487|TWO_SIDED|95.0|-24.12|22.59|||Regression, Linear|||Change from Baseline to Week 8||22.59|-24.12|0.9487
73988317|NCT02188784|147522374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.67||||0.1921|TWO_SIDED|95.0|-31.71|6.37|||Regression, Linear|||Change from Baseline to Week 16||6.37|-31.71|0.1921
73988318|NCT02188784|147522375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|182.43||||0.4296|TWO_SIDED|95.0|-272.14|637.0|||Regression, Linear|||||637.0|-272.14|0.4296
73988319|NCT02188784|147522376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6||||0.0722|TWO_SIDED|95.0|-0.33|7.52|||Regression, Linear|||Change from baseline to week 8||7.52|-0.33|0.0722
73988320|NCT02188784|147522376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71||||0.6927|TWO_SIDED|95.0|-2.83|4.24|||Regression, Linear|||Change from baseline to week 16||4.24|-2.83|0.6927
73988321|NCT02188784|147522377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.0643|TWO_SIDED|95.0|-0.21|7.33|||Regression, Linear|||||7.33|-0.21|0.0643
73988322|NCT02188784|147522378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.4006|TWO_SIDED|95.0|-1.04|2.58|||Regression, Linear|||||2.58|-1.04|0.4006
73988323|NCT01268098|147522399|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|5.0|||>|0.999|TWO_SIDED|95.0|-20.6|30.7||All hypothesis testings in this study were based on type I error of 0.05. Adjustment for multiplicity was not applied.|Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference between the two dose arms.|The 2-sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis corresponding to the primary efficacy endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms. This sample size for this study was not based on the statistical considerations.||30.7|-20.6|>0.999
73988324|NCT01268098|147522400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.258|TWO_SIDED||||||Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference betweenthe two dose arms.||The null hypothesis corresponding to this endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms.||||0.258
74035001|NCT00755846|147622413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7|STANDARD_ERROR_OF_MEAN|7.45||0.117||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.117
73988325|NCT00477464|147522441|SUPERIORITY_OR_OTHER||percentage of participants|59.0|||||TWO_SIDED|95.0|44.2|72.4|||||The estimated value represents the percentage of participants who achieved a best overall response of complete response, partial response, or stable disease.|||72.4|44.2|
73988326|NCT00863798|147522463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.175|TWO_SIDED|95.0|-0.38|2.1||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.||2.10|-0.38|0.175
73988327|NCT00863798|147522463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51||||0.421|TWO_SIDED|95.0|-0.73|1.75||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.||1.75|-0.73|0.421
74039608|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0054|TWO_SIDED|95.0|1.13|1.99|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|1.13|0.0054
74039609|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5493|TWO_SIDED|95.0|0.84|1.39|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.39|0.84|0.5493
73988328|NCT00863798|147522464|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.076
73988329|NCT00863798|147522464|SUPERIORITY_OR_OTHER|||||||0.204|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.204
73988330|NCT00863798|147522465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.13|TWO_SIDED|95.0|-0.04|0.35|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.35|-0.04|0.130
73988331|NCT00863798|147522465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.757|TWO_SIDED|95.0|-0.16|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.23|-0.16|0.757
73988332|NCT00863798|147522466|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.41||||0.114|TWO_SIDED|95.0|-0.34|3.16|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||3.16|-0.34|0.114
73988333|NCT00863798|147522466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.316|TWO_SIDED|95.0|-0.85|2.64|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||2.64|-0.85|0.316
73988334|NCT00863798|147522467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.054|TWO_SIDED|95.0|-0.01|1.5|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.50|-0.01|0.054
73988335|NCT00863798|147522467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.253|TWO_SIDED|95.0|-0.32|1.2|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.20|-0.32|0.253
74035002|NCT00755846|147622414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|6.6||0.014||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.014
74035003|NCT00755846|147622414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|8.35||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.136
74035004|NCT00755846|147622414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|STANDARD_ERROR_OF_MEAN|8.73||0.022||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.022
74035005|NCT00755846|147622414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1|STANDARD_ERROR_OF_MEAN|8.26||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.004
74039610|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0269|TWO_SIDED|95.0|1.03|1.74|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.74|1.03|0.0269
73988336|NCT00863798|147522468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.254||||0.2415|TWO_SIDED|95.0|0.86|1.83|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.83|0.86|0.2415
74039611|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0144|TWO_SIDED|95.0|1.07|1.8|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.80|1.07|0.0144
73988337|NCT00863798|147522468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.102||||0.6169|TWO_SIDED|95.0|0.75|1.61|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.61|0.75|0.6169
73988338|NCT00863798|147522469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.236||||0.3667|TWO_SIDED|95.0|0.78|1.96|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.96|0.78|0.3667
73988339|NCT00863798|147522469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.894||||0.6509|TWO_SIDED|95.0|0.55|1.45|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.45|0.55|0.6509
73988340|NCT00863798|147522470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.182||||0.3893|TWO_SIDED|95.0|0.81|1.73|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.73|0.81|0.3893
73988341|NCT00863798|147522470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.551|TWO_SIDED|95.0|0.77|1.65|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.65|0.77|0.5510
73988342|NCT00863798|147522471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.442||||0.0536|TWO_SIDED|95.0|0.99|2.09|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.||2.09|0.99|0.0536
73875643|NCT02719171|147293369|OTHER||Mean Difference (Final Values)|2.06||||0.204|TWO_SIDED|90.0|-0.61|4.74|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||4.74|-0.61|0.204
73875644|NCT02719171|147293370|OTHER||Mean Difference (Final Values)|1.2||||0.243|TWO_SIDED|90.0|-0.5|2.8|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||2.8|-0.5|0.243
73875645|NCT02719171|147293370|OTHER||Mean Difference (Final Values)|0.1||||0.906|TWO_SIDED|90.0|-1.0|1.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.1|-1.0|0.906
73875646|NCT02719171|147293371|OTHER||Mean Difference (Final Values)|-0.7||||0.325|TWO_SIDED|90.0|-1.8|0.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.5|-1.8|0.325
73875647|NCT02719171|147293371|OTHER||Mean Difference (Final Values)|-0.9||||0.16|TWO_SIDED|90.0|-2.1|0.2|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.2|-2.1|0.160
73875648|NCT02719171|147293372|OTHER||Mean Difference (Final Values)|-1.2||||0.453|TWO_SIDED|90.0|-4.0|1.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.5|-4.0|0.453
73875649|NCT02719171|147293372|OTHER||Mean Difference (Final Values)|-2.8||||0.111|TWO_SIDED|90.0|-5.7|0.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.1|-5.7|0.111
73875650|NCT02719171|147293373|OTHER||Mean Difference (Final Values)|53.5|||<|0.001|TWO_SIDED|90.0|35.9|71.1|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||71.1|35.9|<0.001
73988343|NCT00863798|147522471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.085||||0.6679|TWO_SIDED|95.0|0.75|1.57|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.||1.57|0.75|0.6679
73988344|NCT00863798|147522473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.033|TWO_SIDED|95.0|0.12|2.79|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."||2.79|0.12|0.033
74089823|NCT01421342|147732533|SUPERIORITY||Odds Ratio (OR)|1.74|||<|0.0001|TWO_SIDED|95.0|1.33|2.29|||Regression, Logistic|Stratified by participating medical center (site)|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||2.29|1.33|<0.0001
73875651|NCT02719171|147293373|OTHER||Mean Difference (Final Values)|48.8|||<|0.001|TWO_SIDED|90.0|33.1|64.5|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||64.5|33.1|<0.001
73875652|NCT05736874|147293463|SUPERIORITY|Decision rule based on Bayesian posterior probability of efficacy. The decision threshold was a posterior probability of 0.95. A prespecified skeptical prior for the treatment effect was used to preserve type I error below 0.05.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.91|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.91|
73875653|NCT05736874|147293464|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.19|4.68|||||Descriptive analysis is a maximum partial likelihood proportional hazards regression model. Low event rate precluded covariate adjustment.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||4.68|0.19|
73988345|NCT00863798|147522473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.096|TWO_SIDED|95.0|-0.2|2.49|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."||2.49|-0.20|0.096
73988346|NCT00863798|147522473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.043|TWO_SIDED|95.0|0.02|0.95|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."||0.95|0.02|0.043
73988347|NCT00863798|147522473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.027|TWO_SIDED|95.0|0.06|1.0|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."||1.00|0.06|0.027
73988348|NCT00863798|147522473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.045|TWO_SIDED|95.0|0.01|0.98|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."||0.98|0.01|0.045
74089824|NCT01421342|147732533|SUPERIORITY||Odds Ratio (OR)|1.55||||0.002|TWO_SIDED|95.0|1.17|2.05||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||2.05|1.17|0.002
74089825|NCT01421342|147732534|SUPERIORITY||Odds Ratio (OR)|1.26||||0.11|TWO_SIDED|95.0|0.95|1.68||After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion|||1.68|0.95|0.11
74089826|NCT01421342|147732534|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.26|2.29|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||2.29|1.26|<0.001
73988349|NCT00863798|147522473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.277|TWO_SIDED|95.0|-0.22|0.76|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."||0.76|-0.22|0.277
73988350|NCT00863798|147522473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.056|TWO_SIDED|95.0|-0.01|0.91|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."||0.91|-0.01|0.056
73988351|NCT00863798|147522473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.355|TWO_SIDED|95.0|-0.24|0.68|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."||0.68|-0.24|0.355
73988352|NCT00863798|147522474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.002|TWO_SIDED|95.0|-2.53|-0.56|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||-0.56|-2.53|0.002
73988353|NCT00863798|147522474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.129|TWO_SIDED|95.0|-1.75|0.22|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.22|-1.75|0.129
73988354|NCT00863798|147522475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.3097|TWO_SIDED|95.0|0.52|1.23|||Regression, Linear|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.23|0.52|0.3097
74089827|NCT01421342|147732534|SUPERIORITY||Odds Ratio (OR)|1.37||||0.043|TWO_SIDED|95.0|1.01|1.86||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic||Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||1.86|1.01|0.043
74089828|NCT00834652|147732535|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73988355|NCT00863798|147522475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.272||||0.2794|TWO_SIDED|95.0|0.82|1.97|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.97|0.82|0.2794
73988356|NCT00863798|147522477|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.||||0.805
73988357|NCT00863798|147522477|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.||||0.805
73988358|NCT00863798|147522477|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.||||0.978
73988359|NCT00863798|147522477|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||Regression, Logistic|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.||||0.805
73988360|NCT00863798|147522477|SUPERIORITY_OR_OTHER|||||||0.154|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.||||0.154
73988361|NCT00863798|147522477|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.||||0.805
73988362|NCT02509312|147522550|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
73988363|NCT02509312|147522551|SUPERIORITY|||||||0.257|||||||Chi-squared|||||||.257
73988364|NCT02509312|147522552|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||||||0.085
73988365|NCT02509312|147522553|SUPERIORITY|||||||0.164|||||||Wilcoxon (Mann-Whitney)|||||||0.164
73988366|NCT02509312|147522554|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
73988367|NCT02509312|147522555|SUPERIORITY||Risk Difference (RD)|-0.27||||0.0367|TWO_SIDED|95.0|-0.52|-0.03|||Chi-squared|||||-0.03|-0.52|0.0367
73988368|NCT02509312|147522556|SUPERIORITY|||||||0.0231|||||||Wilcoxon (Mann-Whitney)|||||||0.0231
73988369|NCT02509312|147522557|SUPERIORITY|||||||0.467|||||||Wilcoxon (Mann-Whitney)|||||||0.467
73988370|NCT02509312|147522558|SUPERIORITY|||||||0.273|||||||Wilcoxon (Mann-Whitney)|||||||0.273
73988371|NCT02509312|147522559|SUPERIORITY|||||||0.0162||||||p-value for 12 hours post-op between-group comparison.|t-test, 2 sided|||||||0.0162
73988372|NCT02509312|147522561|SUPERIORITY|||||||0.048||||||p-value for 6 hours post-op between-group comparison.|Wilcoxon (Mann-Whitney)|||||||0.048
74089829|NCT01642914|147732547|SUPERIORITY_OR_OTHER|||||||0.0054|ONE_SIDED||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution||||||0.0054
74089830|NCT01642914|147732547|SUPERIORITY_OR_OTHER|||||||0.0012|ONE_SIDED||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution||||||0.0012
74089831|NCT01642914|147732560|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.193||||0.0006|TWO_SIDED|95.0|0.086|0.3||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||.300|.086|0.0006
74089832|NCT01642914|147732560|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.17||||0.0022|TWO_SIDED|95.0|0.064|0.227||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||.227|.064|0.0022
74089833|NCT01642914|147732561|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.37||||0.0054|TWO_SIDED|95.0|1.09|1.72|||Log Rank|Log-rank test stratified by geographic region.||||1.72|1.09|.0054
74089834|NCT01642914|147732561|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.24||||0.047|TWO_SIDED|95.0|0.99|1.55|||Log Rank|Log-rank test stratified by geographic region.||||1.55|0.99|0.0470
74089835|NCT01642914|147732567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23||||0.0264|TWO_SIDED|95.0|1.09|4.56||p-values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||4.56|1.09|0.0264
73988373|NCT00702650|147522568|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||One-Sample Binomial (Wald) test, 2-sided|||||||<0.001
73988374|NCT00702650|147522573|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Sexual Desire based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
73988375|NCT00702650|147522573|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Overall Sexual Activity Score based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
73988376|NCT00702650|147522573|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Erection Maintained for Satisfactory Duration based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
73988377|NCT00702650|147522573|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Positive Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
73988378|NCT00702650|147522573|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Negative Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
73988379|NCT00702650|147522574|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||p-value for Physical Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided|||||||0.0254
73988380|NCT00702650|147522574|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value for Mental Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided|||||||<0.0001
73988381|NCT03954223|147522583|SUPERIORITY|||||||0.4|TWO_SIDED|95.0|||||ANOVA|||||||0.4
73988382|NCT03954223|147522584|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.2|TWO_SIDED|95.0|||||Regression, Linear|Mixed-effects generalized linear model of the glycemic profile change extracted from CGM data.||||||0.2
73988383|NCT00943722|147522632|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio be greater than 0.67.|GMT ratio|1.9|||<|0.001|TWO_SIDED|95.0|1.7|2.14||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||2.14|1.70|< 0.001
73988384|NCT00943722|147522632|NON_INFERIORITY|Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.83|||<|0.001|TWO_SIDED|95.0|1.63|2.06||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||2.06|1.63|< 0.001
74089836|NCT06005597|147732568|SUPERIORITY||Least Squares (LS) Means|-48.61|STANDARD_ERROR_OF_MEAN|4.959|<|0.0001|TWO_SIDED|95.0|-58.33|-38.89|||ANCOVA|||||-38.89|-58.33|<.0001
74089837|NCT06005597|147732569|SUPERIORITY||Least Squares (LS) Means|-27.94|STANDARD_ERROR_OF_MEAN|4.893|<|0.0001|TWO_SIDED|95.0|-37.53|-18.35|||ANCOVA|||||-18.35|-37.53|<.0001
74089838|NCT06005597|147732570|SUPERIORITY||Least Squares (LS) Means|-16.76|STANDARD_ERROR_OF_MEAN|4.918||0.0007|TWO_SIDED|95.0|-26.4|-7.12|||ANCOVA|||||-7.12|-26.40|0.0007
74089839|NCT06005597|147732571|SUPERIORITY||Least Squares (LS) Means|-31.85|STANDARD_ERROR_OF_MEAN|4.993|<|0.0001|TWO_SIDED|95.0|-41.64|-22.07|||ANCOVA|||||-22.07|-41.64|<.0001
74089840|NCT06005597|147732572|SUPERIORITY||Least Squares (LS) Means|-45.13|STANDARD_ERROR_OF_MEAN|4.233|<|0.0001|TWO_SIDED|95.0|-53.43|-36.84|||ANCOVA|||||-36.84|-53.43|<.0001
73988385|NCT00943722|147522632|NON_INFERIORITY|Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.98|||<|0.001|TWO_SIDED|95.0|1.77|2.22||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||2.22|1.77|< 0.001
73988386|NCT00943722|147522632|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.44|||<|0.001|TWO_SIDED|95.0|2.13|2.8||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||2.80|2.13|< 0.001
73988387|NCT00943722|147522632|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.51|||<|0.001|TWO_SIDED|95.0|2.21|2.85||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||2.85|2.21|< 0.001
73988388|NCT00943722|147522632|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.87|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||2.36|1.87|< 0.001
73988389|NCT00943722|147522632|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.62|||<|0.001|TWO_SIDED|95.0|2.27|3.03||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||3.03|2.27|< 0.001
73988390|NCT00943722|147522632|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.22|||<|0.001|TWO_SIDED|95.0|1.97|2.51||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||2.51|1.97|< 0.001
73988391|NCT00943722|147522632|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.18|||<|0.001|TWO_SIDED|95.0|1.93|2.45||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||2.45|1.93|< 0.001
73988392|NCT00943722|147522633|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.31|||<|0.001|TWO_SIDED|95.0|2.07|2.59||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||2.59|2.07|< 0.001
73988393|NCT00943722|147522633|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.88|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||2.36|1.88|< 0.001
73988394|NCT00943722|147522633|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.45|||<|0.001|TWO_SIDED|95.0|2.19|2.74||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||2.74|2.19|< 0.001
73988395|NCT00943722|147522633|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.2|||<|0.001|TWO_SIDED|95.0|2.8|3.65||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||3.65|2.80|< 0.001
73988396|NCT00943722|147522633|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.95|||<|0.001|TWO_SIDED|95.0|2.6|3.34||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||3.34|2.60|< 0.001
73988397|NCT00943722|147522633|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.57|||<|0.001|TWO_SIDED|95.0|2.29|2.88||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||2.88|2.29|< 0.001
73988398|NCT00943722|147522633|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.33|||<|0.001|TWO_SIDED|95.0|2.89|3.84||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||3.84|2.89|< 0.001
74035006|NCT00755846|147622414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|STANDARD_ERROR_OF_MEAN|8.48||0.04||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.040
74039612|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0846|TWO_SIDED|95.0|0.97|1.7|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|0.97|0.0846
73875654|NCT05736874|147293467|SUPERIORITY|Statistical analysis was a Bayesian proportional hazards regression model with covariate adjustment and weakly informative priors.|Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|0.8|3.5|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||3.5|0.8|
73988399|NCT00943722|147522633|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.47|||<|0.001|TWO_SIDED|95.0|2.19|2.79||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||2.79|2.19|< 0.001
73988400|NCT00943722|147522633|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.66|||<|0.001|TWO_SIDED|95.0|2.37|2.98||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||2.98|2.37|< 0.001
73988401|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.97|||||TWO_SIDED|95.0|0.88|1.08|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6||1.08|0.88|
74039613|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0101|TWO_SIDED|95.0|1.09|1.91|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.91|1.09|0.0101
73988402|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.03|||||TWO_SIDED|95.0|0.93|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.16|0.93|
73988403|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.06|||||TWO_SIDED|95.0|0.95|1.19|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.19|0.95|
74089841|NCT06005597|147732573|SUPERIORITY||Least Squares (LS) Means|-29.19|STANDARD_ERROR_OF_MEAN|3.467|<|0.0001|TWO_SIDED|95.0|-35.99|-22.4|||ANCOVA|||||-22.40|-35.99|<.0001
74089842|NCT06005597|147732574|SUPERIORITY||Least Squares (LS) Means|-29.9|STANDARD_ERROR_OF_MEAN|4.274|<|0.0001|TWO_SIDED|95.0|-38.28|-21.53|||ANCOVA|||||-21.53|-38.28|<.0001
74089843|NCT06005597|147732575|SUPERIORITY||Least Squares (LS) Means|-19.78|STANDARD_ERROR_OF_MEAN|3.549|<|0.0001|TWO_SIDED|95.0|-26.73|-12.82|||ANCOVA|||||-12.82|-26.73|<.0001
74089844|NCT06005597|147732576|SUPERIORITY||Least Squares (LS) Means|-25.44|STANDARD_ERROR_OF_MEAN|4.198|<|0.0001|TWO_SIDED|95.0|-33.67|-17.22|||ANCOVA|||||-17.22|-33.67|<.0001
74089845|NCT06005597|147732577|SUPERIORITY||Least Squares (LS) Means|-14.21|STANDARD_ERROR_OF_MEAN|3.495|<|0.0001|TWO_SIDED|95.0|-21.06|-7.36|||ANCOVA|||||-7.36|-21.06|<.0001
74089846|NCT06005597|147732578|SUPERIORITY||Least Squares (LS) Means|-15.23|STANDARD_ERROR_OF_MEAN|4.236||0.0003|TWO_SIDED|95.0|-23.53|-6.93|||ANCOVA|||||-6.93|-23.53|0.0003
74089847|NCT06005597|147732579|SUPERIORITY||Least Squares (LS) Means|-9.42|STANDARD_ERROR_OF_MEAN|3.493||0.007|TWO_SIDED|95.0|-16.26|-2.57|||ANCOVA|||||-2.57|-16.26|0.007
73988404|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.0|||||TWO_SIDED|95.0|0.9|1.11|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11||1.11|0.90|
74089848|NCT00754442|147732580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED|95.0||||see above|t-test, 2 sided|95%||The null hypothesis is that there is no statistical difference between patients and controls at baseline||||0.1
74089849|NCT00754442|147732580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 4 hours||||0.002
74089850|NCT00754442|147732580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 8 hrs||||0.003
74089851|NCT04479475|147732591|OTHER|The Wilcoxon signed-rank test is a non-parametric statistical test. We used it to assess repeated measures of missed methadone doses.|Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|10.8||0.0094|TWO_SIDED|||||Exact p-value reported due to small sample size|Wilcoxon signed-rank test||We opted not to include the 95% confidence interval due to the non-parametric nature of the data.|||||0.0094
74089852|NCT00296491|147732593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.2|STANDARD_ERROR_OF_MEAN|5.41|<|0.001||95.0|12.5|33.8|||t-test, 2 sided||Treatment Difference = FSC - MON|||33.8|12.5|<0.001
74089853|NCT00296491|147732594|NON_INFERIORITY_OR_EQUIVALENCE|Given estimates, and assuming a significance level of a=0.05, a sample size of 133 subjects per treatment was determined to be sufficient to provide 80% power to show equivalance.|Mean Difference (Net)|-8.9|STANDARD_ERROR_OF_MEAN|8.0|<|0.127||95.0|-24.6|6.9|||t-test, 2 sided||Treatment Difference=FSC+MON-FSC|||6.9|-24.6|<0.127
74089854|NCT01300052|147732603|SUPERIORITY_OR_OTHER||Difference in Percentage|3.8|||||TWO_SIDED|95.0|-14.3|21.8||||||Difference in percentage was calculated as values of AN2728 Ointment, 2% group minus values of AN2728 Ointment, Vehicle group.||21.8|-14.3|
74089855|NCT01231373|147732614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.34|||<|0.0001|TWO_SIDED|95.0|-4.63|-2.04|||ANCOVA|||Comparison of polidocanol treatment groups versus placebo (absolute change from baseline to week 8 in patient assessment of symptoms of varicose veins (VVSymQ) score.||-2.04|-4.63|<0.0001
74089856|NCT01231373|147732614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.74|||ANCOVA|||||-2.74|-5.26|<0.0001
73988405|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.20|0.95|
74089857|NCT01231373|147732614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.05|||<|0.0001|TWO_SIDED|95.0|-4.33|-1.77|||ANCOVA|||||-1.77|-4.33|<0.0001
74089858|NCT01231373|147732615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-0.88|-0.45|||ANCOVA|||||-0.45|-0.88|<0.0001
74089859|NCT01231373|147732615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.078|<|0.0001|TWO_SIDED|95.0|-1.04|-0.61|||ANCOVA|||||-0.61|-1.04|<0.0001
74089860|NCT01231373|147732615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.54|||ANCOVA|||||-0.54|-0.97|<0.0001
74089861|NCT01231373|147732616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|-1.59|-0.87|||ANCOVA|||||-0.87|-1.59|<0.0001
74089862|NCT01231373|147732616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.129|<|0.0001|TWO_SIDED|95.0|-1.9|-1.18|||ANCOVA|||||-1.18|-1.90|<0.0001
74089863|NCT01231373|147732616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.83|-1.11|||ANCOVA|||||-1.11|-1.83|<0.0001
74089864|NCT02312713|147732636|SUPERIORITY||Mean Difference (Final Values)|-3.36||||0.06|TWO_SIDED|95.0|-6.84|0.12|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.12|-6.84|0.06
74089865|NCT02312713|147732636|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.39|TWO_SIDED|95.0|-5.26|2.08|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||2.08|-5.26|0.39
74089866|NCT02312713|147732636|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.14|TWO_SIDED|95.0|-6.24|0.85|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.85|-6.24|0.14
73988406|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.20|0.95|
73988407|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|0.96|||||TWO_SIDED|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16||1.06|0.86|
73988408|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.12|0.90|
73988409|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.17|0.94|
73988410|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.14|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18||1.14|0.89|
73988411|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||TWO_SIDED|95.0|0.98|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.26|0.98|
73988412|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||TWO_SIDED|95.0|0.97|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.26|0.97|
73988413|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31||1.13|0.89|
73988414|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||TWO_SIDED|95.0|0.91|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.16|0.91|
73988415|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.15|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.15|0.90|
74089867|NCT02312713|147732636|SUPERIORITY||Mean Difference (Final Values)|-2.63||||0.17|TWO_SIDED|95.0|-6.37|1.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||1.11|-6.37|0.17
74089868|NCT02312713|147732636|NON_INFERIORITY|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|0.67||||0.65|TWO_SIDED|95.0|-2.23|3.56|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.56|-2.23|0.65
73988416|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33||1.16|0.94|
73988417|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.17|0.94|
73988418|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.12|0.90|
73988419|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.84|||||TWO_SIDED|95.0|0.73|0.95|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45||0.95|0.73|
73988420|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.04|||||TWO_SIDED|95.0|0.91|1.18|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.18|0.91|
73988421|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.24|||||TWO_SIDED|95.0|1.08|1.42|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.42|1.08|
73988422|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.92|||||TWO_SIDED|95.0|0.83|1.03|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52||1.03|0.83|
73988423|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||TWO_SIDED|95.0|0.85|1.07|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.07|0.85|
73988424|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.03|||||TWO_SIDED|95.0|0.92|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.16|0.92|
73988425|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||TWO_SIDED|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58||1.06|0.86|
73988426|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.07|||||TWO_SIDED|95.0|0.96|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.20|0.96|
73988427|NCT00943722|147522634|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.12|||||TWO_SIDED|95.0|1.0|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.26|1.00|
73988428|NCT00943722|147522638|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||1.5|-0.8|< 0.001
73988429|NCT00943722|147522638|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||1.2|-0.7|< 0.001
73988430|NCT00943722|147522638|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||1.2|-0.7|< 0.001
73988431|NCT00943722|147522638|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||1.5|-0.8|< 0.001
73988432|NCT00943722|147522638|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||1.7|-0.4|< 0.001
73988433|NCT00943722|147522638|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||1.6|-0.4|< 0.001
73988434|NCT00943722|147522638|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.6|1.8|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||1.8|-0.6|< 0.001
73988435|NCT00943722|147522638|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||1.7|-0.4|< 0.001
73988436|NCT00943722|147522638|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||1.2|-0.7|< 0.001
73988437|NCT00943722|147522639|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.7|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||1.5|-0.7|< 0.001
73988438|NCT00943722|147522639|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||1.2|-0.7|< 0.001
73988439|NCT00943722|147522639|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||1.2|-0.7|< 0.001
73988440|NCT00943722|147522639|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||1.6|-0.4|< 0.001
73988441|NCT00943722|147522639|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||1.7|-0.4|< 0.001
73988442|NCT00943722|147522639|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||1.6|-0.4|< 0.001
74039614|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0848|TWO_SIDED|95.0|0.97|1.62|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.97|0.0848
74039615|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8732|TWO_SIDED|95.0|0.79|1.32|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.32|0.79|0.8732
74039616|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2734|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.89|0.2734
73988443|NCT00943722|147522639|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.5|||<|0.001|TWO_SIDED|95.0|-0.1|2.0|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||2.0|-0.1|< 0.001
73988444|NCT00943722|147522639|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||1.7|-0.4|< 0.001
73988445|NCT00943722|147522639|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||1.2|-0.7|< 0.001
73988446|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.9|0.9|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6||0.9|-0.9|
73988447|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.5|||||TWO_SIDED|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.7|-0.4|
73988448|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.6|||||TWO_SIDED|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.7|-0.4|
73988449|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11||0.7|-0.7|
73988450|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.3|-0.4|
73988451|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.3|-0.4|
73988452|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16||0.7|-0.7|
73988453|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.3|-0.4|
73988454|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.3|-0.4|
73988455|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18||0.5|-1.1|
73988456|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.1|-0.7|
73988457|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.3|-0.4|
73988458|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31||0.7|-0.7|
73988459|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.6|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.0|-0.6|
73988460|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.5|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.0|-0.5|
73988461|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33||0.7|-0.7|
74089869|NCT02312713|147732636|NON_INFERIORITY|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|-1.04||||0.51|TWO_SIDED|95.0|-4.13|2.05|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||2.05|-4.13|0.51
73988462|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.3|-0.4|
73988463|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.3|-0.4|
73988464|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45||0.5|-1.1|
73988465|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.1|-0.7|
74089870|NCT02312713|147732637|SUPERIORITY||Median Difference (Final Values)|0.56||||0.01|TWO_SIDED|95.0|0.15|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.98|0.15|0.01
74089871|NCT02312713|147732637|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.28|TWO_SIDED|95.0|-0.19|0.65|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.65|-0.19|0.28
74089872|NCT02312713|147732637|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.75|TWO_SIDED|95.0|-0.35|0.49|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.49|-0.35|0.75
74089873|NCT02312713|147732637|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.22|TWO_SIDED|95.0|-0.16|0.7|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.7|-0.16|0.22
73988466|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.3|-0.4|
73988467|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52||0.7|-0.7|
73988468|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.3|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.3|-0.4|
73988469|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.3|-0.4|
73988470|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58||0.7|-0.7|
73988471|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.3|-0.4|
74039617|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2839|TWO_SIDED|95.0|0.86|1.7|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|0.86|0.2839
74039618|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0238|TWO_SIDED|95.0|1.05|2.07|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.07|1.05|0.0238
74039619|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5212|TWO_SIDED|95.0|0.81|1.53|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.81|0.5212
74039620|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5954|TWO_SIDED|95.0|0.8|1.48|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.80|0.5954
74039621|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0638|TWO_SIDED|95.0|0.98|1.79|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.79|0.98|0.0638
74039622|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.38||||0.2661|TWO_SIDED|95.0|0.78|2.44|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.44|0.78|0.2661
74039623|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.24||||0.4717|TWO_SIDED|95.0|0.69|2.21|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.21|0.69|0.4717
74039624|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.17||||0.5798|TWO_SIDED|95.0|0.68|2.0|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.68|0.5798
74039625|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5027|TWO_SIDED|95.0|0.72|1.95|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.95|0.72|0.5027
73988472|NCT00943722|147522640|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.3|-0.4|
73988473|NCT01036165|147522652|SUPERIORITY_OR_OTHER||Mean positive response|0.78|||||TWO_SIDED|95.0|0.7|0.86|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower limit of the 95% confidence interval was \>0.50.|||0.86|0.70|
73988474|NCT01387815|147522664|OTHER||||||<|0.001|||||||Chi-squared|||Comparison does not include missing.||||<0.001
73988475|NCT01387815|147522665|OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
74035007|NCT00755846|147622414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|8.47||0.378||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.378
74035008|NCT00755846|147622415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|5.37||0.718||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.718
74035009|NCT00755846|147622415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|6.8||0.346||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.346
74035010|NCT00755846|147622415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|7.13||0.901||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.901
74035011|NCT00755846|147622415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|6.79||0.851||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.851
74035012|NCT00755846|147622415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|6.86||0.825||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.825
74039626|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8165|TWO_SIDED|95.0|0.64|1.77|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.77|0.64|0.8165
73988476|NCT01387815|147522666|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73988477|NCT01387815|147522667|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73988478|NCT01387815|147522668|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73988479|NCT01387815|147522669|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73988480|NCT01387815|147522670|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
73988481|NCT01387815|147522671|OTHER|||||||0.016|||||||t-test, 2 sided|||||||0.016
73988482|NCT01387815|147522672|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.060
73988483|NCT01387815|147522673|OTHER|||||||0.056|||||||t-test, 2 sided|||||||0.056
73988484|NCT01387815|147522674|OTHER|||||||0.755|||||||t-test, 2 sided|||||||0.755
73988485|NCT01387815|147522675|OTHER|||||||0.091|||||||t-test, 2 sided|||||||0.091
73988486|NCT01387815|147522676|OTHER|||||||0.106|||||||t-test, 2 sided|||||||0.106
73988487|NCT01387815|147522677|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
73988488|NCT01387815|147522678|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
73988489|NCT01387815|147522679|OTHER|||||||0.083|||||||t-test, 2 sided|||||||0.083
73988490|NCT01387815|147522680|OTHER|||||||0.495|||||||t-test, 2 sided|||||||0.495
73988491|NCT01387815|147522681|OTHER|||||||0.097|||||||t-test, 2 sided|||||||0.097
73988492|NCT01387815|147522682|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
73988493|NCT01387815|147522683|OTHER|||||||0.037|||||||t-test, 2 sided|||||||0.037
73875655|NCT05736874|147293468|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.62|1.63|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||1.63|0.62|
73988494|NCT01387815|147522684|OTHER|||||||0.084|||||||t-test, 2 sided|||||||0.084
73988495|NCT01387815|147522685|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.090
73988496|NCT01387815|147522686|OTHER|||||||0.059|||||||t-test, 2 sided|||||||0.059
73988497|NCT01387815|147522687|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
73988498|NCT01387815|147522688|OTHER|||||||0.115|||||||t-test, 2 sided|||||||0.115
73988499|NCT01387815|147522689|OTHER|||||||0.002|||||||Log Rank|||||||0.002
73875656|NCT05736874|147293469|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.42|1.5|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||1.50|0.42|
73988500|NCT01387815|147522690|OTHER|||||||0.002|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.002
73988501|NCT01387815|147522691|OTHER|"Comparison does not include the Missing category."||||||0.017|||||||Chi-squared|||||||0.017
73988502|NCT01387815|147522692|OTHER|||||||0.01||||||"Comparison does not include the Missing category."|Chi-squared|||||||0.010
73988503|NCT01387815|147522693|OTHER|||||||0.015|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.015
73988504|NCT01387815|147522694|OTHER|||||||0.06|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.060
73988505|NCT01387815|147522695|OTHER|||||||0.501|||||||t-test, 2 sided|||||||0.501
73988506|NCT01387815|147522696|OTHER|||||||0.807|||||||t-test, 2 sided|||||||0.807
73988507|NCT01387815|147522697|OTHER|||||||0.479|||||||t-test, 2 sided|||||||0.479
73988508|NCT01387815|147522698|OTHER|||||||0.918|||||||t-test, 2 sided|||||||0.918
73988509|NCT01387815|147522699|OTHER|||||||0.609|||||||t-test, 2 sided|||||||0.609
73988510|NCT01387815|147522700|OTHER|||||||0.367|||||||t-test, 2 sided|||||||0.367
73988511|NCT01387815|147522701|OTHER|||||||0.521|||||||t-test, 2 sided|||||||0.521
73988512|NCT01387815|147522702|OTHER|||||||0.793|||||||t-test, 2 sided|||||||0.793
73988513|NCT01387815|147522703|OTHER|||||||0.442|||||||t-test, 2 sided|||||||0.442
73988514|NCT01387815|147522704|OTHER|||||||0.434|||||||t-test, 2 sided|||||||0.434
73988515|NCT01387815|147522705|OTHER|||||||0.752|||||||t-test, 2 sided|||||||0.752
73988516|NCT01387815|147522706|OTHER|||||||0.469|||||||t-test, 2 sided|||||||0.469
73988517|NCT01387815|147522707|OTHER|||||||0.419|||||||t-test, 2 sided|||||||0.419
73988518|NCT01387815|147522708|OTHER|||||||0.695|||||||t-test, 2 sided|||||||0.695
73988519|NCT01387815|147522709|OTHER|||||||0.452|||||||t-test, 2 sided|||||||0.452
73988520|NCT01387815|147522710|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
73988521|NCT01387815|147522711|OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
73988522|NCT01387815|147522712|OTHER|||||||0.252|||||||t-test, 2 sided|||||||0.252
73988523|NCT01387815|147522716|OTHER|||||||0.143|||||||Chi-squared|||||||0.143
73988524|NCT01387815|147522717|OTHER|||||||0.415|||||||Chi-squared|||||||0.415
73988525|NCT01387815|147522718|OTHER|||||||0.604|||||||Chi-squared|||||||0.604
73988526|NCT01387815|147522719|OTHER|||||||0.504|||||||Fisher Exact|||||||0.504
73988527|NCT01387815|147522720|OTHER|||||||0.92|||||||Chi-squared|||||||0.920
73988528|NCT01387815|147522721|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
73988529|NCT01387815|147522722|OTHER|||||||0.575|||||||Chi-squared|||||||0.575
73988530|NCT01387815|147522725|OTHER|||||||0.856|||||||Chi-squared|||||||0.856
73988531|NCT01387815|147522726|OTHER|||||||0.623|||||||Chi-squared|||||||0.623
73988532|NCT01387815|147522727|OTHER|||||||0.732|||||||Chi-squared|||||||0.732
73988533|NCT01387815|147522728|OTHER|||||||0.896|||||||t-test, 2 sided|||||||0.896
73988534|NCT01387815|147522729|OTHER|||||||0.879|||||||t-test, 2 sided|||||||0.879
73988535|NCT01387815|147522730|OTHER|||||||0.763|||||||t-test, 2 sided|||||||0.763
73988536|NCT01387815|147522731|OTHER|||||||0.657|||||||Chi-squared|||||||0.657
73988537|NCT01387815|147522732|OTHER|||||||0.987|||||||Chi-squared|||||||0.987
73988538|NCT01387815|147522733|OTHER|||||||0.011|||||||Fisher Exact|||||||0.011
73988539|NCT01387815|147522734|OTHER|||||||0.351|||||||t-test, 2 sided|||||||0.351
73988540|NCT01387815|147522735|OTHER|||||||0.835|||||||t-test, 2 sided|||||||0.835
73988541|NCT01387815|147522737|OTHER|||||||0.714|||||||Fisher Exact|||||||0.714
73988542|NCT01387815|147522738|OTHER|||||||0.737|||||||Fisher Exact|||||||0.737
73988543|NCT01387815|147522739|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
73988544|NCT01387815|147522743|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
73988545|NCT01387815|147522744|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
73988546|NCT01387815|147522746|OTHER|||||||0.714|||||||Fisher Exact|||||||0.714
73988547|NCT01387815|147522747|OTHER|||||||0.747|||||||Fisher Exact|||||||0.747
73988548|NCT01387815|147522748|OTHER|||||||0.495|||||||Fisher Exact|||||||0.495
73988549|NCT01387815|147522752|OTHER|||||||0.364|||||||Fisher Exact|||||||0.364
73988550|NCT01387815|147522753|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
73988551|NCT01387815|147522754|OTHER|||||||0.723|||||||Fisher Exact|||||||0.723
73988552|NCT01387815|147522761|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
73988553|NCT01387815|147522762|OTHER|||||||0.672|||||||t-test, 2 sided|||||||0.672
73988554|NCT01387815|147522763|OTHER|||||||0.482|||||||t-test, 2 sided|||||||0.482
73988555|NCT01387815|147522764|OTHER|||||||0.938|||||||t-test, 2 sided|||||||0.938
73988556|NCT01387815|147522765|OTHER|||||||0.144|||||||t-test, 2 sided|||||||0.144
73988557|NCT01387815|147522766|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.360
74089874|NCT02312713|147732637|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.5||||0|TWO_SIDED|95.0|-0.84|-0.16|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||-0.16|-0.84|0.00
73988558|NCT01387815|147522767|OTHER|||||||0.808|||||||t-test, 2 sided|||||||0.808
73988559|NCT01387815|147522768|OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
73988560|NCT01387815|147522769|OTHER|||||||0.184|||||||t-test, 2 sided|||||||0.184
73988561|NCT01387815|147522770|OTHER|||||||0.305|||||||t-test, 2 sided|||||||0.305
73988562|NCT01387815|147522772|OTHER|||||||0.757|||||||t-test, 2 sided|||||||0.757
73988563|NCT01387815|147522773|OTHER|||||||0.321|||||||t-test, 2 sided|||||||0.321
73988564|NCT01387815|147522774|OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
73988565|NCT01387815|147522775|OTHER|||||||0.395|||||||t-test, 2 sided|||||||0.395
73988566|NCT01387815|147522777|OTHER|||||||0.739|||||||t-test, 2 sided|||||||0.739
73988567|NCT01387815|147522778|OTHER|||||||0.291|||||||t-test, 2 sided|||||||0.291
73988568|NCT01844726|147522815|SUPERIORITY||Mean Difference (Net)|0.05||||0.1|TWO_SIDED||||||t-test, 2 sided|||Change in BOLD signal activation across task derived learning circuit were compared between GLYX-13 and placebo groups using an independent group t-test.||||.10
74089875|NCT02312713|147732637|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.04||||0.83|TWO_SIDED|95.0|-0.31|0.39|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.39|-0.31|0.83
73988569|NCT01844726|147522816|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||.57
73988570|NCT03231969|147522868|SUPERIORITY||Mean Difference (Final Values)|-0.791||||0.0002|TWO_SIDED|95.0|-1.203|-0.378|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-0.378|-1.203|0.0002
73988571|NCT03231969|147522868|SUPERIORITY||Mean Difference (Final Values)|-0.851|||<|0.0001|TWO_SIDED|95.0|-1.263|-0.439|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-0.439|-1.263|<.0001
73988572|NCT03231969|147522868|SUPERIORITY||Mean Difference (Final Values)|-1.545|||<|0.0001|TWO_SIDED|95.0|-1.954|-1.135|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-1.135|-1.954|<.0001
73988573|NCT03231969|147522868|SUPERIORITY||Mean Difference (Final Values)|-1.208|||<|0.0001|TWO_SIDED|95.0|-1.639|-0.778|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-0.778|-1.639|<.0001
73988574|NCT03231969|147522868|SUPERIORITY||Mean Difference (Final Values)|-1.245|||<|0.0001|TWO_SIDED|95.0|-1.679|-0.811|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-0.811|-1.679|<.0001
73988575|NCT03231969|147522868|SUPERIORITY||Mean Difference (Final Values)|-1.846|||<|0.0001|TWO_SIDED|95.0|-2.273|-1.418|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-1.418|-2.273|<.0001
73988576|NCT03231969|147522868|SUPERIORITY||Mean Difference (Final Values)|-1.696|||<|0.0001|TWO_SIDED|95.0|-2.08|-1.312|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.312|-2.080|<.0001
73988577|NCT03231969|147522868|SUPERIORITY||Mean Difference (Final Values)|-1.617|||<|0.0001|TWO_SIDED|95.0|-2.001|-1.232|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.232|-2.001|<.0001
73988578|NCT03231969|147522868|SUPERIORITY||Mean Difference (Final Values)|-2.009|||<|0.0001|TWO_SIDED|95.0|-2.387|-1.63|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.630|-2.387|<.0001
73988579|NCT01193218|147522988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.87|-0.57||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 5mg minus placebo||-0.57|-0.87|<0.0001
73988580|NCT01193218|147522988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.55||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 10mg minus placebo||-0.55|-0.85|<0.0001
73988581|NCT01193218|147522988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 25mg minus placebo||-0.80|-1.10|<0.0001
73988582|NCT01193218|147522988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.06|-0.76||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 50mg minus placebo||-0.76|-1.06|<0.0001
73988583|NCT01193218|147522989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.367|||<|0.0001|TWO_SIDED|95.0|5.34|70.236|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.||Odds ratio calculated as the odds of Empa 5mg divided by the odds of placebo||70.236|5.340|<0.0001
73875657|NCT05736874|147293470|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors|Odds Ratio (OR)|2.74|||||TWO_SIDED|95.0|0.5|5.94|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||5.94|0.50|
73875658|NCT05736874|147293471|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.69|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.11|0.69|
73875659|NCT05736874|147293471|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.78|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.34|0.78|
73988584|NCT01193218|147522989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.889||||0.0003|TWO_SIDED|95.0|2.942|40.301|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.||Odds ratio calculated as the odds of Empa 10mg divided by the odds of placebo||40.301|2.942|0.0003
73988585|NCT01193218|147522989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.624|||<|0.0001|TWO_SIDED|95.0|7.601|99.99|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.|The upper limit of confidence interval is actually \>99.99|Odds ratio calculated as the odds of Empa 25mg divided by the odds of placebo||99.99|7.601|<0.0001
73988586|NCT01193218|147522989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.906|||<|0.0001|TWO_SIDED|95.0|12.12|99.99|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.|The upper limit of confidence interval is actually \>99.99|Odds ratio calculated as the odds of Empa 50mg divided by the odds of placebo||99.99|12.120|<0.0001
73988587|NCT01193218|147522990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.7|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-31.61|-21.8|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 5mg minus placebo||-21.80|-31.61|<0.0001
73988588|NCT01193218|147522990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.34|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-34.25|-24.42|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 10mg minus placebo||-24.42|-34.25|<0.0001
73988589|NCT01193218|147522990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.75|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-42.66|-32.84|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 25mg minus placebo||-32.84|-42.66|<0.0001
73988590|NCT01193218|147522990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-41.51|-31.69|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 50mg minus placebo||-31.69|-41.51|<0.0001
73988591|NCT01013740|147522992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||||95.0|0.53|1.35|||||The Pike estimator of the treatment HR was based on the log rank test.|||1.35|0.53|
73988592|NCT01013740|147522997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.63|3.58||||||||3.58|0.63|
73988593|NCT00338949|147523001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.228|||||||t-test, 2 sided|||||||0.228
73988594|NCT00338949|147523002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958|||||||t-test, 2 sided|||||||0.958
74039627|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1996|TWO_SIDED|95.0|0.92|1.52|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.52|0.92|0.1996
73988595|NCT01125566|147523068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.4224||95.0|0.87|1.41||Two sided p-value was derived from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|||1.41|0.87|0.4224
73988596|NCT01125566|147523069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.024|TWO_SIDED|95.0|1.03|1.63||Two sided p-value from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.63|1.03|0.0240
73988597|NCT01125566|147523070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.6431||95.0|0.756|1.572|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours Afatinib.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.572|0.756|0.6431
74039628|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0074|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.10|0.0074
73875660|NCT05736874|147293471|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.78|1.45|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.45|0.78|
73988598|NCT01125566|147523071|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.029||||0.8829||95.0|0.707|1.496|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours AV.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.496|0.707|0.8829
73988599|NCT02484547|147523094|SUPERIORITY||Difference|-0.26||||0.0901|TWO_SIDED|95.0|-0.569|0.041|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.041|-0.569|0.0901
73988600|NCT02484547|147523094|SUPERIORITY||Difference|-0.39||||0.012|TWO_SIDED|95.0|-0.694|-0.086|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit.||-0.086|-0.694|0.0120
73988601|NCT02484547|147523095|SUPERIORITY||Difference|-0.1||||0.7578|TWO_SIDED|95.0|-0.65|0.48|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.48|-0.65|0.7578
73988602|NCT02484547|147523095|SUPERIORITY||Difference|0.6||||0.0493|TWO_SIDED|95.0|0.0|1.13|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||1.13|0.00|0.0493
73988603|NCT02484547|147523096|SUPERIORITY||Difference|-0.701||||0.1962|TWO_SIDED|95.0|-1.7649|0.3627|||MMRM|||Adjusted mean for each treatment group(Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADASCog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region, and laboratory ApoE status.||0.3627|-1.7649|0.1962
73988604|NCT02484547|147523096|SUPERIORITY||Difference|-1.4||||0.0097|TWO_SIDED|95.0|-2.4596|-0.3396|||MMRM|||Adjusted mean for each treatment group(Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADASCog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region, and laboratory ApoE status.||-0.3396|-2.4596|0.0097
73988605|NCT02484547|147523097|SUPERIORITY||Difference|0.7||||0.1515|TWO_SIDED|95.0|-0.27|1.73|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low dose and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-MCI as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||1.73|-0.27|0.1515
73988606|NCT02484547|147523097|SUPERIORITY||Difference|1.7||||0.0006|TWO_SIDED|95.0|0.75|2.74|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low dose and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-MCI as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||2.74|0.75|0.0006
73988607|NCT01424189|147523133|NON_INFERIORITY_OR_EQUIVALENCE|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCDVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This was based on an assumed standard deviation for UCDVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.013|||ONE_SIDED|95.0||0.03||||||||0.030||
73988608|NCT01424189|147523134|NON_INFERIORITY_OR_EQUIVALENCE|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCNVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This estimate was based on an assumed standard deviation for UCNVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.015|||ONE_SIDED|95.0||-0.017||||||||-0.017||
73988609|NCT01077622|147523150|SUPERIORITY_OR_OTHER||percentage of participants|70.0|||||TWO_SIDED|95.0|34.8|93.3|||||SERC assessment|||93.3|34.8|
73988610|NCT01077622|147523150|SUPERIORITY_OR_OTHER||percentage of participants|70.0|||||TWO_SIDED|95.0|34.8|93.3|||||Investigator assessment|||93.3|34.8|
73988611|NCT00424177|147523192|SUPERIORITY_OR_OTHER||Proportion of subjects in Cycle 2 or 3|0.87||||||95.0|0.74|0.94||||||||0.94|0.74|
73988612|NCT04159805|147523200|SUPERIORITY||Difference in Least Square (LS) Mean|0.29|||=|0.772|TWO_SIDED|95.0|-1.72|2.3||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||2.30|-1.72|=0.772
74089876|NCT02312713|147732638|SUPERIORITY||Mean Difference (Final Values)|7.75||||0.04|TWO_SIDED|95.0|0.43|15.07|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for the 2 Minute Step Test.||15.07|0.43|0.04
73875661|NCT05736874|147293471|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.79|1.53|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.53|0.79|
73988613|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|1.01|||=|0.299|TWO_SIDED|95.0|-0.94|2.97||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||2.97|-0.94|=0.299
73988614|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|-0.11|||=|0.924|TWO_SIDED|95.0|-2.34|2.13||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||2.13|-2.34|=0.924
73988615|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|1.86|||=|0.091|TWO_SIDED|95.0|-0.32|4.04||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||4.04|-0.32|=0.091
73988616|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|-0.18|||=|0.887|TWO_SIDED|95.0|-2.82|2.45||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||2.45|-2.82|=0.887
73988617|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|1.8|||=|0.162|TWO_SIDED|95.0|-0.76|4.36||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||4.36|-0.76|=0.162
73988618|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|-0.36|||=|0.784|TWO_SIDED|95.0|-3.01|2.29||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||2.29|-3.01|=0.784
73988619|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|1.79|||=|0.166|TWO_SIDED|95.0|-0.79|4.37||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||4.37|-0.79|=0.166
73988620|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|0.42|||=|0.724|TWO_SIDED|95.0|-1.98|2.82||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||2.82|-1.98|=0.724
73988621|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|1.81|||=|0.124|TWO_SIDED|95.0|-0.52|4.14||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.14|-0.52|=0.124
73988622|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|0.29|||=|0.856|TWO_SIDED|95.0|-2.91|3.48||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||3.48|-2.91|=0.856
73875662|NCT05736874|147293472|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.72|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.09|0.72|
73988623|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|1.64|||=|0.292|TWO_SIDED|95.0|-1.48|4.76||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||4.76|-1.48|=0.292
73988624|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|0.11|||=|0.944|TWO_SIDED|95.0|-3.14|3.37||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||3.37|-3.14|=0.944
73988625|NCT04159805|147523200|SUPERIORITY||Difference in LS Mean|0.85|||=|0.589|TWO_SIDED|95.0|-2.33|4.02||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||4.02|-2.33|=0.589
73988626|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|-0.93|||=|0.406|TWO_SIDED|95.0|-3.17|1.31||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||1.31|-3.17|=0.406
73988627|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|0.9|||=|0.418|TWO_SIDED|95.0|-1.34|3.14||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.14|-1.34|=0.418
74039629|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3557|TWO_SIDED|95.0|0.87|1.45|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.45|0.87|0.3557
74035013|NCT00755846|147622415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|6.94||0.843||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.843
73875663|NCT05736874|147293472|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.84|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.27|0.84|
73988628|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|-0.94|||=|0.463|TWO_SIDED|95.0|-3.53|1.65||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||1.65|-3.53|=0.463
73988629|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|-0.1|||=|0.936|TWO_SIDED|95.0|-2.7|2.49||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||2.49|-2.70|=0.936
73988630|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|-1.8|||=|0.17|TWO_SIDED|95.0|-4.41|0.82||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||0.82|-4.41|=0.170
73988631|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|0.52|||=|0.687|TWO_SIDED|95.0|-2.1|3.13||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||3.13|-2.10|=0.687
73988632|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|-1.24|||=|0.374|TWO_SIDED|95.0|-4.05|1.57||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||1.57|-4.05|=0.374
73988633|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|0.99|||=|0.478|TWO_SIDED|95.0|-1.82|3.8||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.80|-1.82|=0.478
73988634|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|-0.51|||=|0.69|TWO_SIDED|95.0|-3.12|2.09||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||2.09|-3.12|=0.690
73988635|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|2.12|||=|0.106|TWO_SIDED|95.0|-0.48|4.71||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.71|-0.48|=0.106
74089877|NCT02312713|147732638|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.78|TWO_SIDED|95.0|-6.59|8.82|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for the 2 Minute Step Test.||8.82|-6.59|0.78
73988636|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|-0.89|||=|0.547|TWO_SIDED|95.0|-3.89|2.12||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||2.12|-3.89|=0.547
73988637|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|2.19|||=|0.144|TWO_SIDED|95.0|-0.81|5.18||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||5.18|-0.81|=0.144
73988638|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|-1.37|||=|0.431|TWO_SIDED|95.0|-4.91|2.17||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||2.17|-4.91|=0.431
73988639|NCT04159805|147523201|SUPERIORITY||Difference in LS Mean|1.2|||=|0.488|TWO_SIDED|95.0|-2.34|4.74|||MMRM|||Change From Baseline at Week 16||4.74|-2.34|=0.488
73988640|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|-0.34|||=|0.855|TWO_SIDED|95.0|-4.14|3.45||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.45|-4.14|=0.855
73988641|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|3.19|||=|0.093|TWO_SIDED|95.0|-0.56|6.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||6.95|-0.56|=0.093
73988642|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|1.8|||=|0.41|TWO_SIDED|95.0|-2.61|6.2||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||6.20|-2.61|=0.410
73988643|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|3.13|||=|0.154|TWO_SIDED|95.0|-1.25|7.5||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||7.50|-1.25|=0.154
73988644|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|-0.94|||=|0.662|TWO_SIDED|95.0|-5.29|3.41||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||3.41|-5.29|=0.662
73988645|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|3.26|||=|0.13|TWO_SIDED|95.0|-1.02|7.54||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||7.54|-1.02|=0.130
73988646|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|1.27|||=|0.586|TWO_SIDED|95.0|-3.44|5.98||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||5.98|-3.44|=0.586
73988647|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|4.93|||=|0.039|TWO_SIDED|95.0|0.26|9.6||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||9.60|0.26|=0.039
73988648|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|-0.22|||=|0.909|TWO_SIDED|95.0|-4.03|3.6||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||3.60|-4.03|=0.909
73988649|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|2.65|||=|0.158|TWO_SIDED|95.0|-1.09|6.4||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||6.40|-1.09|=0.158
73988650|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|-0.88|||=|0.764|TWO_SIDED|95.0|-6.8|5.05||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||5.05|-6.80|=0.764
74039630|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.36||||0.017|TWO_SIDED|95.0|1.06|1.75|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.75|1.06|0.0170
73988651|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|5.2|||=|0.08|TWO_SIDED|95.0|-0.67|11.06||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||11.06|-0.67|=0.080
73988652|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|-1.01|||=|0.677|TWO_SIDED|95.0|-5.98|3.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||3.95|-5.98|=0.677
73988653|NCT04159805|147523202|SUPERIORITY||Difference in LS Mean|4.81|||=|0.055|TWO_SIDED|95.0|-0.1|9.73||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||9.73|-0.10|=0.055
73988654|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|0.52|||=|0.78|TWO_SIDED|95.0|-3.23|4.27||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||4.27|-3.23|=0.780
73988655|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|0.5|||=|0.771|TWO_SIDED|95.0|-2.99|3.99||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.99|-2.99|=0.771
73988656|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|-0.04|||=|0.984|TWO_SIDED|95.0|-4.22|4.14||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||4.14|-4.22|=0.984
73988657|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|2.44|||=|0.213|TWO_SIDED|95.0|-1.47|6.35||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||6.35|-1.47|=0.213
73988658|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|-1.97|||=|0.371|TWO_SIDED|95.0|-6.4|2.45||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||2.45|-6.40|=0.371
73988659|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|0.11|||=|0.956|TWO_SIDED|95.0|-4.01|4.23||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||4.23|-4.01|=0.956
73988660|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|-1.06|||=|0.641|TWO_SIDED|95.0|-5.65|3.53||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.53|-5.65|=0.641
73988661|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|-0.33|||=|0.876|TWO_SIDED|95.0|-4.61|3.95||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.95|-4.61|=0.876
73988662|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|-1.86|||=|0.458|TWO_SIDED|95.0|-6.91|3.18||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||3.18|-6.91|=0.458
73988663|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|-0.68|||=|0.769|TWO_SIDED|95.0|-5.37|4.0||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.00|-5.37|=0.769
73988664|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|-1.14|||=|0.699|TWO_SIDED|95.0|-7.07|4.8||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||4.80|-7.07|=0.699
73988665|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|1.1|||=|0.687|TWO_SIDED|95.0|-4.41|6.62||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||6.62|-4.41|=0.687
73988666|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|0.2|||=|0.944|TWO_SIDED|95.0|-5.55|5.95||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||5.95|-5.55|=0.944
73988667|NCT04159805|147523203|SUPERIORITY||Difference in LS Mean|2.48|||=|0.351|TWO_SIDED|95.0|-2.87|7.83||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||7.83|-2.87|=0.351
73988668|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-27.9|||=|0.09|TWO_SIDED|95.0|-60.18|4.38||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 2||4.38|-60.18|=0.090
73988669|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-15.77|||=|0.328|TWO_SIDED|95.0|-47.5|15.96||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 2||15.96|-47.50|=0.328
73988670|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-12.65|||=|0.441|TWO_SIDED|95.0|-44.94|19.63||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 3||19.63|-44.94|=0.441
74089878|NCT02312713|147732638|SUPERIORITY||Mean Difference (Final Values)|4.88||||0.2|TWO_SIDED|95.0|-2.56|12.33|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for the 2 Minute Step Test.||12.33|-2.56|0.20
74089879|NCT02312713|147732638|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.78|TWO_SIDED|95.0|-6.74|8.99|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for the 2 Minute Step Test.||8.99|-6.74|.78
73988671|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|1.39|||=|0.931|TWO_SIDED|95.0|-30.33|33.12||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 3||33.12|-30.33|=0.931
73988672|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-28.18|||=|0.087|TWO_SIDED|95.0|-60.46|4.11||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||4.11|-60.46|=0.087
73988673|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|4.44|||=|0.783|TWO_SIDED|95.0|-27.29|36.16||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||36.16|-27.29|=0.783
73988674|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-29.08|||=|0.077|TWO_SIDED|95.0|-61.36|3.21||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 5||3.21|-61.36|=0.077
73988675|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-15.72|||=|0.33|TWO_SIDED|95.0|-47.45|16.0||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 5||16.00|-47.45|=0.330
73988676|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-14.14|||=|0.4|TWO_SIDED|95.0|-47.19|18.91||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||18.91|-47.19|=0.400
73988677|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|0.0|||=|1|TWO_SIDED|95.0|-32.18|32.19||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||32.19|-32.18|=1.000
73875664|NCT05736874|147293472|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.20|0.76|
73875665|NCT05736874|147293472|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.84|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.32|0.84|
73988678|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-26.47|||=|0.117|TWO_SIDED|95.0|-59.64|6.69||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 7||6.69|-59.64|=0.117
73988679|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-12.75|||=|0.436|TWO_SIDED|95.0|-44.94|19.44||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 7||19.44|-44.94|=0.436
73988680|NCT04159805|147523204|SUPERIORITY|From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|Difference in LS Mean|-47.91|||=|0.005|TWO_SIDED|95.0|-81.54|-14.29||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||-14.29|-81.54|=0.005
73988681|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-20.48|||=|0.215|TWO_SIDED|95.0|-52.92|11.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||11.95|-52.92|=0.215
73988682|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-3.97|||=|0.815|TWO_SIDED|95.0|-37.34|29.4||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||29.40|-37.34|=0.815
73988683|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-4.31|||=|0.794|TWO_SIDED|95.0|-36.84|28.22||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||28.22|-36.84|=0.794
73988684|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-36.78|||=|0.033|TWO_SIDED|95.0|-70.48|-3.08||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||-3.08|-70.48|=0.033
73988685|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-10.79|||=|0.513|TWO_SIDED|95.0|-43.26|21.67||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 12||21.67|-43.26|=0.513
74035014|NCT00755846|147622416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|4.88||0.069||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.069
74039631|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8641|TWO_SIDED|95.0|0.76|1.38|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.38|0.76|0.8641
73875666|NCT05736874|147293473|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.58|0.93|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||0.93|0.58|
73988686|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-56.21|||=|0.002|TWO_SIDED|95.0|-91.69|-20.73||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 14||-20.73|-91.69|=0.002
73988687|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-36.94|||=|0.036|TWO_SIDED|95.0|-71.39|-2.48||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 14||-2.48|-71.39|=0.036
73988688|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-62.98|||=|0.001|TWO_SIDED|95.0|-100.64|-25.31||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 16||-25.31|-100.64|=0.001
73988689|NCT04159805|147523204|SUPERIORITY||Difference in LS Mean|-28.81|||=|0.13|TWO_SIDED|95.0|-66.12|8.51||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 16||8.51|-66.12|=0.130
73875667|NCT05736874|147293473|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.76|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.32|0.76|
73875668|NCT05736874|147293473|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.71|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.25|0.71|
73875669|NCT05736874|147293473|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.64|0.89|
73875670|NCT05736874|147293474|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.15|0.70|
73875671|NCT05736874|147293474|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.29|0.75|
73875672|NCT05736874|147293474|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.26|0.72|
73875673|NCT05736874|147293474|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.92|1.61|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.61|0.92|
73875674|NCT05736874|147293475|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.81|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.28|0.81|
73988690|NCT01502371|147523211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.87||||0.019|TWO_SIDED|95.0|0.64|7.09||Constrained longitudinal data analysis (cLDA) model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. Placebo||7.09|0.64|0.019
73988691|NCT01502371|147523211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.29|||<|0.001|TWO_SIDED|95.0|3.05|9.53||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 100 mcg BID vs. Placebo||9.53|3.05|<0.001
73875675|NCT05736874|147293475|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.6|0.99|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||0.99|0.60|
73875676|NCT05736874|147293475|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.74|1.23|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.23|0.74|
73875677|NCT05736874|147293475|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.89|1.5|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.50|0.89|
73875678|NCT05736874|147293476|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.69|1.06|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.06|0.69|
73875679|NCT05736874|147293476|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.82|1.3|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.30|0.82|
73875680|NCT05736874|147293476|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.8|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.32|0.80|
73988692|NCT01502371|147523211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.34||||0.001|TWO_SIDED|95.0|2.07|8.61||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 200 mcg BID vs. Placebo||8.61|2.07|0.001
73988693|NCT01502371|147523212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.15||||0.045|TWO_SIDED|95.0|0.43|37.87||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||37.87|0.43|0.045
73988694|NCT01502371|147523212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|27.35||||0.004|TWO_SIDED|95.0|8.63|46.08||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||46.08|8.63|0.004
73988695|NCT01502371|147523212|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.01||||0.057|TWO_SIDED|95.0|-0.51|36.53||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||36.53|-0.51|0.057
73988696|NCT01502371|147523213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.28|TWO_SIDED|95.0|-0.08|0.27||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.27|-0.08|0.280
73988697|NCT01502371|147523213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.178|TWO_SIDED|95.0|-0.06|0.3||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.30|-0.06|0.178
73988698|NCT01502371|147523213|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.18||||0.045|TWO_SIDED|95.0|0.0|0.36||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.36|0.00|0.045
73988699|NCT01502371|147523214|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.39||||0.368|TWO_SIDED|95.0|-1.65|4.44||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. MF DPI 100 mcg QD. Only participants who received MF MDI 50 mcg BID or MF DPI 100 mcg QD were included in the statistical analysis.||4.44|-1.65|0.368
73988700|NCT02154347|147523215|SUPERIORITY||Mean Difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.95|-0.37|||t-test, 2 sided|||||-0.37|-0.95|<0.001
73988701|NCT03282799|147523238|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
73988702|NCT03282799|147523239|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
73988703|NCT03282799|147523240|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
73988704|NCT03282799|147523241|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
73988705|NCT03282799|147523242|OTHER|||||||0.685|||||||Wilcoxon (Mann-Whitney)|||||||.685
73988706|NCT03282799|147523243|OTHER|||||||0.784|||||||Wilcoxon (Mann-Whitney)|||||||.784
73988707|NCT03282799|147523244|OTHER|||||||0.587|||||||Wilcoxon (Mann-Whitney)|||||||.587
73988708|NCT03282799|147523245|OTHER|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||||||.394
73988709|NCT03282799|147523246|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||.660
73988710|NCT03282799|147523247|OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.290
73988711|NCT01171183|147523292|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.52|STANDARD_DEVIATION|37.64||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
73988712|NCT01171183|147523293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_DEVIATION|4.54||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
73988713|NCT01726049|147523323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-4.5|-0.3||||||||-0.3|-4.5|
73988714|NCT01726049|147523323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||||TWO_SIDED|95.0|-7.1|-2.3||||||||-2.3|-7.1|
73988715|NCT01726049|147523324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.9|1.4||||||||1.4|-0.9|
73988716|NCT01726049|147523324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-0.3|1.6||||||||1.6|-0.3|
73988717|NCT01726049|147523325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.9|0.1||||||||0.1|-0.9|
73988718|NCT01726049|147523325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||||0.1|-0.5|
73988719|NCT01726049|147523326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.9|1.0||||||||1.0|-1.9|
73988720|NCT01726049|147523326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|||||TWO_SIDED|95.0|-5.2|-1.8||||||||-1.8|-5.2|
73988721|NCT02416713|147523333|SUPERIORITY||relative change from baseline|0.66||||0.12|TWO_SIDED|95.0|-0.18|1.51|||Mixed Models Analysis|||||1.51|-0.18|0.12
73988722|NCT02416713|147523333|SUPERIORITY||relative change from baseline|-0.3||||0.49|TWO_SIDED|95.0|-1.17|0.57|||Mixed Models Analysis|||||0.57|-1.17|0.49
73988723|NCT02416713|147523333|SUPERIORITY||Slope|-0.16||||0.7|TWO_SIDED|95.0|-1.0|0.69|||Mixed Models Analysis|||||0.69|-1.00|0.70
73988724|NCT04333732|147523358|SUPERIORITY||Risk Difference (RD)|0.3||||0.52|TWO_SIDED|95.0|-0.5|1.1|||Regression, Logistic|||The primary endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\<50 vs. ≥50), and a random effect for site||1.1|-0.5|0.52
73988725|NCT04333732|147523359|SUPERIORITY||Risk Difference (RD)|0.04||||0.95|TWO_SIDED|95.0|-1.4|1.3|||Regression, Logistic|difference, 0·04%, 95% CI, -1·4% to 1·3%, p=0·95).||The endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\<50 vs. ≥50), and a random effect for site||1.3|-1.4|0.95
73988726|NCT00511836|147523381|SUPERIORITY_OR_OTHER||||||<|2e-05|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0.||||<0.00002
73988727|NCT00511836|147523384|SUPERIORITY_OR_OTHER||||||<|0.013|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0||||<0.013
73988728|NCT00511836|147523385|SUPERIORITY_OR_OTHER|||||||0.245|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0||||0.245
73988729|NCT01936324|147523386|OTHER|||||||0.0003|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center.||||||0.0003
73988730|NCT01936324|147523387|OTHER|||||||0.0032|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center||||||0.0032
73988731|NCT01936324|147523388|OTHER|||||||0.007|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study center||||||0.0070
73988732|NCT00362375|147523390|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.05|TWO_SIDED|95.0|1.28|4.5|||Generalized Estimating Equation|||GEE cluster-adjusted odds ratio||4.50|1.28|<0.05
73988733|NCT00362375|147523391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|||<|0.05|TWO_SIDED|95.0|0.2|1.16|||GEE|||||1.16|0.20|<0.05
73988734|NCT00362375|147523392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39|||<|0.05|TWO_SIDED|95.0|0.99|1.95|||GEE|||||1.95|0.99|<0.05
73988735|NCT00362375|147523393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07|||<|0.05|TWO_SIDED|95.0|0.8|1.44|||GEE|GEE incident rate ratio||||1.44|0.80|<0.05
73988736|NCT00362375|147523394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|||<|0.05|TWO_SIDED|95.0|0.76|2.71|||GEE|||||2.71|0.76|<0.05
73988737|NCT04190225|147523419|SUPERIORITY||Median Difference (Final Values)|18.4||||0.04|TWO_SIDED|95.0|4.67|37.28|||quantile regression||Median difference is not the difference in the two medians, but is the median of differences between groups (why it is 18.4 and not 23)|||37.28|4.67|0.04
73988738|NCT04190225|147523420|SUPERIORITY||Median Difference (Final Values)|23.5||||0.03|TWO_SIDED|95.0|8.35|32.76|||quantile regression|||||32.76|8.35|0.03
73988739|NCT01114139|147523425|SUPERIORITY|The 95% confidence interval was calculated using the large sample assumption.|Treatment Difference|75.59|||<|0.0001|TWO_SIDED|95.0|71.15|80.02|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - placebo) was expressed as a percentage.|Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.||80.02|71.15|<0.0001
73988740|NCT01917006|147523435|SUPERIORITY||Least square mean difference|0.11||||0.393||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from analysis of covariance (ANCOVA) Model with treatment as fixed effect and baseline geometric mean IELT as covariate.|ANCOVA|||||||0.393
73988741|NCT01917006|147523435|SUPERIORITY||Least Square Mean Difference|0.25||||0.263||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.263
73988742|NCT01917006|147523435|SUPERIORITY||Least square mean difference|-0.39||||0.861||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.861
73988743|NCT01917006|147523435|SUPERIORITY||Least square mean difference|-0.14||||0.647||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.647
73988744|NCT01917006|147523435|SUPERIORITY||Least square mean difference|-0.13||||0.645||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.645
73988745|NCT01917006|147523435|SUPERIORITY||Least square mean difference|0.15||||0.343||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.343
73988746|NCT01917006|147523436|SUPERIORITY||Least square mean difference|55.33||||0.184||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 versus (vs) Placebo at Week 2||||0.184
73988747|NCT01917006|147523436|SUPERIORITY||Least square mean difference|170.21||||0.002||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2||||0.002
73988748|NCT01917006|147523436|SUPERIORITY||Least square mean difference|12.73||||0.404||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2||||0.404
74035015|NCT00755846|147622416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|STANDARD_ERROR_OF_MEAN|6.14||0.018||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.018
74035016|NCT00755846|147622416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_ERROR_OF_MEAN|6.47||0.258||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.258
74035017|NCT00755846|147622416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|6.13||0.299||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.299
74035018|NCT00755846|147622416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|6.27||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.103
74035019|NCT00755846|147622416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|6.32||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.340
73875681|NCT05736874|147293476|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.29|0.75|
73988749|NCT01917006|147523436|SUPERIORITY||Least square mean difference|24.23||||0.328||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2||||0.328
73988750|NCT01917006|147523436|SUPERIORITY||Least square mean difference|18.48||||0.362||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2||||0.362
73988751|NCT01917006|147523436|SUPERIORITY||Least square mean difference|45.42||||0.203||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2||||0.203
74039632|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1768|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.91|0.1768
73875682|NCT05736874|147293477|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.62|0.93|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||0.93|0.62|
73988752|NCT01917006|147523436|SUPERIORITY||Least square mean difference|33.05||||0.322||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4||||0.322
73988753|NCT01917006|147523436|SUPERIORITY||Least square mean difference|148.86||||0.015||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4||||0.015
73988754|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-6.2||||0.541||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4||||0.541
73988755|NCT01917006|147523436|SUPERIORITY||Least square mean difference|6.47||||0.459||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4||||0.459
73988756|NCT01917006|147523436|SUPERIORITY||Least square mean difference|1.32||||0.491||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4||||0.491
73988757|NCT01917006|147523436|SUPERIORITY||Least square mean difference|36.8||||0.281||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4||||0.281
73988758|NCT01917006|147523436|SUPERIORITY||Least square mean difference|14.12||||0.424||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6||||0.424
73988759|NCT01917006|147523436|SUPERIORITY||Least square mean difference|136.96||||0.026||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6||||0.026
73988760|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-27.62||||0.67||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6||||0.670
73988761|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-10.06||||0.561||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6||||0.561
73988762|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-16.58||||0.604||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6||||0.604
73988763|NCT01917006|147523436|SUPERIORITY||Least square mean difference|17.76||||0.394||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6||||0.394
73988764|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-5.94||||0.532||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8||||0.532
73988765|NCT01917006|147523436|SUPERIORITY||Least square mean difference|111.27||||0.058||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8||||0.058
73988766|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-48.65||||0.778||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8||||0.778
73988767|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-27.74||||0.662||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8||||0.662
73988768|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-35.72||||0.712||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8||||0.712
73988769|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-0.18||||0.501||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8||||0.501
73988770|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-12.14||||0.565||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10||||0.565
73988771|NCT01917006|147523436|SUPERIORITY||Least square mean difference|102.44||||0.071||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10||||0.071
73988772|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-52.81||||0.799||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10||||0.799
73988773|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-30.81||||0.681||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10||||0.681
74039633|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7696|TWO_SIDED|95.0|0.55|1.55|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.55|0.7696
73875683|NCT05736874|147293477|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.78|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.18|0.78|
73875684|NCT05736874|147293477|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.74|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.12|0.74|
73875685|NCT05736874|147293477|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|1.02|1.56|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.56|1.02|
73875686|NCT05736874|147293478|SUPERIORITY||Difference in model estimate time unwell|-0.1|||||TWO_SIDED|95.0|-0.45|0.26|||||The interval is a highest-density credible interval.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||0.26|-0.45|
73875687|NCT05736874|147293479|SUPERIORITY||Difference in model estimated means|0.13|||||TWO_SIDED|95.0|-0.28|0.58|||||The interval is a highest-density credible interval.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||0.58|-0.28|
73988774|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-40.68||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10||||0.741
73988775|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-4.33||||0.526||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10||||0.526
73988776|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-14.76||||0.584||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 12||||0.584
73988777|NCT01917006|147523436|SUPERIORITY||Least square mean difference|84.09||||0.101||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 12||||0.101
73988778|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-55.14||||0.823||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 12||||0.823
73875688|NCT03057496|147293497|SUPERIORITY||Rate ratio|0.627|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.536|0.734||Since the outcome (contacts) represented over-dispersed count data and there were repeated measurements per subject, a generalized mixed effects model with a negative binomial family was used with each subject treated as a random intercept.|Mixed Models Analysis|Fixed factors were included in the model to account for factors other than device operating mode that might affect collision rates.|Silent mode is the denominator for the rate ratio.|A within-subject comparison was performed. Each subject included in the analysis used the device in both the active and the silent mode. Comparison was between the two device operating modes. The null hypothesis was that there was no difference in the rate of contacts between active and silent modes.||0.734|0.536|< 0.001
73875689|NCT03270943|147293501|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.02
73875690|NCT03270943|147293502|OTHER|within group|Mean Difference (Net)|-1.01|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-6.06|3.84|||||Difference between score at 8 weeks and score at baseline.|||3.84|-6.06|
73875691|NCT03270943|147293502|OTHER|within group|Mean Difference (Net)|-4.46|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-8.7|-0.22|||||Difference between score at 8 weeks and score at baseline.|||-0.22|-8.70|
73875692|NCT03270943|147293503|OTHER|within group change|Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.72|0.2|||||Difference between score at 8 weeks and score at baseline.|||0.2|-2.72|
73875693|NCT03270943|147293503|OTHER|within group change|Mean Difference (Net)|-1.72|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-3.6|0.16|||||Difference between score at 8 weeks and score at baseline.|||0.16|-3.60|
73875694|NCT03270943|147293504|OTHER|Within group change|Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.15|0.61|||||Difference between score at 8 weeks and score at baseline.|||0.61|-0.15|
73875695|NCT03270943|147293504|OTHER|within group change|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.07|0.63|||||Difference between score at 8 weeks and score at baseline.|||0.63|0.07|
73875696|NCT02981368|147293518|SUPERIORITY|||||||0.1097|||||||Fisher Exact|||Tissue Site: Bone||||0.1097
73988779|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-40.18||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 12||||0.741
73988780|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-41.31||||0.756||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 12||||0.756
73988781|NCT01917006|147523436|SUPERIORITY||Least square mean difference|-2.57||||0.517||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 12||||0.517
73875697|NCT02981368|147293518|SUPERIORITY|||||||0.1087|||||||Fisher Exact|||Tissue Site: Bone||||0.1087
73988782|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.59||||0.079||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 2||||0.079
73988783|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.77||||0.025||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2||||0.025
73988784|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.07||||0.417||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2||||0.417
73988785|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.16||||0.33||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2||||0.330
73988786|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.3||||0.199||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2||||0.199
73988787|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.45||||0.113||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2||||0.113
73988788|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.5||||0.127||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4||||0.127
73988789|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.56||||0.087||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4||||0.087
73875698|NCT02981368|147293518|SUPERIORITY|||||||0.1949|||||||Fisher Exact|||Tissue Site: Bone||||0.1949
73875699|NCT02981368|147293518|SUPERIORITY|||||||0.1315|||||||Fisher Exact|||Tissue Site: Bone||||0.1315
73875700|NCT02981368|147293518|SUPERIORITY|||||||0.1977|||||||Fisher Exact|||Tissue Site: Bone||||0.1977
73875701|NCT02981368|147293518|SUPERIORITY|||||||0.2149|||||||Fisher Exact|||Tissue Site: Bone||||0.2149
73875702|NCT02981368|147293518|SUPERIORITY|||||||0.2582|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.2582
73875703|NCT02981368|147293518|SUPERIORITY|||||||0.0009|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.0009
73875704|NCT02981368|147293518|SUPERIORITY|||||||0.3588|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.3588
73875705|NCT02981368|147293518|SUPERIORITY|||||||0.8791|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.8791
73875706|NCT02981368|147293518|SUPERIORITY|||||||0.9457|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.9457
73988790|NCT01917006|147523437|SUPERIORITY||Least square mean difference|-0.04||||0.543||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4||||0.543
73988791|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.12||||0.377||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4||||0.377
73988792|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.17||||0.321||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4||||0.321
73988793|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.4||||0.149||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4||||0.149
73988794|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.35||||0.215||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6||||0.215
73988795|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.47||||0.126||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6||||0.126
74039634|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7433|TWO_SIDED|95.0|0.66|1.78|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.78|0.66|0.7433
73988796|NCT01917006|147523437|SUPERIORITY||Least square mean difference|-0.28||||0.774||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6||||0.774
73988797|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.01||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6||||0.495
73988798|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.0||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6||||0.495
73988799|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.23||||0.274||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6||||0.274
73988800|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.22||||0.308||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8||||0.308
73988801|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.34||||0.205||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8||||0.205
73988802|NCT01917006|147523437|SUPERIORITY||Least square mean difference|-0.39||||0.849||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8||||0.849
73988803|NCT01917006|147523437|SUPERIORITY||Least square mean difference|-0.07||||0.571||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8||||0.571
73988804|NCT01917006|147523437|SUPERIORITY||Least square mean difference|-0.09||||0.592||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8||||0.592
73988805|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.16||||0.34||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8||||0.340
73875707|NCT02981368|147293518|SUPERIORITY|||||||0.2705|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.2705
73875708|NCT02981368|147293518|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
73875709|NCT02981368|147293518|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
73988806|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.16||||0.36||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10||||0.360
73988807|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.35||||0.192||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10||||0.192
73988808|NCT01917006|147523437|SUPERIORITY||Least square mean difference|-0.37||||0.843||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10||||0.843
73988809|NCT01917006|147523437|SUPERIORITY||Least square mean difference|-0.07||||0.572||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10||||0.572
73988810|NCT01917006|147523437|SUPERIORITY||Least square mean difference|-0.12||||0.628||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10||||0.628
73988811|NCT01917006|147523437|SUPERIORITY||Least square mean difference|0.12||||0.38||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10||||0.380
73988812|NCT01475461|147523443|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.172||0.5206|TWO_SIDED|80.0|-0.21|0.23||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.23|-0.21|0.5206
73875710|NCT02981368|147293518|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
73875711|NCT02981368|147293518|SUPERIORITY|||||||0.5933|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.5933
73875712|NCT02981368|147293518|SUPERIORITY|||||||0.7094|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.7094
73875713|NCT02981368|147293518|SUPERIORITY|||||||0.5424|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.5424
73875714|NCT02981368|147293518|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: Prostate Gland||||<0.0001
73875715|NCT02981368|147293518|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Tissue Site: Prostate Gland||||<0.0001
73875716|NCT02981368|147293518|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Tissue Site: Prostate Gland||||<0.0001
73875717|NCT02981368|147293518|SUPERIORITY|||||||0.0038|||||||Fisher Exact|||Tissue Site: Prostate Gland||||0.0038
73875718|NCT02981368|147293518|SUPERIORITY|||||||0.0647|||||||Fisher Exact|||Tissue Site: Prostate Gland||||0.0647
73875719|NCT02981368|147293518|SUPERIORITY|||||||0.0021|||||||Chi-squared|||Tissue Site: Prostate Gland||||0.0021
73875720|NCT02981368|147293518|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
73875721|NCT02981368|147293518|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
73875722|NCT02981368|147293518|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
73875723|NCT02981368|147293518|SUPERIORITY|||||||0.0815|||||||Chi-squared|||Tissue Site: All||||0.0815
73875724|NCT02981368|147293518|SUPERIORITY|||||||0.7507|||||||Chi-squared|||Tissue Site: All||||0.7507
73875725|NCT02981368|147293518|SUPERIORITY|||||||0.562|||||||Chi-squared|||Tissue Site: All||||0.5620
73875726|NCT02723773|147293526|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|79.77|||||TWO_SIDED|95.0|73.72|84.61|||Poisson regression method||VE=1 - the relative risk (RR). RR=the ratio of the incidence rates of LTFU+Control \>=50YOA Group over Historical Control \>=50YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=50 YOA Group and Historical Control \>=50 YOA Group.||84.61|73.72|
73875727|NCT02723773|147293527|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|75.55|93.36|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.||93.36|75.55|
73875728|NCT02723773|147293527|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.14|||||TWO_SIDED|95.0|74.17|94.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||94.35|74.17|
73988813|NCT01475461|147523443|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.178||0.1645|TWO_SIDED|80.0|-0.4|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo||0.05|-0.40|0.1645
74039635|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0562|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.65|0.99|0.0562
73875729|NCT02723773|147293527|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|77.11|||||TWO_SIDED|95.0|69.37|83.14|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=60 YOA Group over Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||83.14|69.37|
73875730|NCT02723773|147293527|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|73.18|||||TWO_SIDED|95.0|62.94|80.92|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=70 YOA Group over Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||80.92|62.94|
73875731|NCT02723773|147293528|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.73|||||TWO_SIDED|95.0|84.89|90.12|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control 50 YOA Group.||90.12|84.89|
73988814|NCT01475461|147523443|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.172||0.1592|TWO_SIDED|80.0|-0.39|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.05|-0.39|0.1592
73988815|NCT01475461|147523443|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.174||0.0049|TWO_SIDED|80.0|-0.68|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.23|-0.68|0.0049
73988816|NCT01475461|147523443|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.173||0.0068|TWO_SIDED|80.0|-0.65|-0.21||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.21|-0.65|0.0068
73988817|NCT01475461|147523444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.097||0.3434|TWO_SIDED|80.0|-0.16|0.09||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.09|-0.16|0.3434
73988818|NCT01475461|147523444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.101||0.0892|TWO_SIDED|80.0|-0.27|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.01|-0.27|0.0892
73988819|NCT01475461|147523444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.097||0.0826|TWO_SIDED|80.0|-0.26|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.01|-0.26|0.0826
73988820|NCT01475461|147523444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.098||0.0031|TWO_SIDED|80.0|-0.4|-0.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.15|-0.40|0.0031
73988821|NCT01475461|147523444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.098||0.0005|TWO_SIDED|80.0|-0.45|-0.2||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.20|-0.45|0.0005
73988822|NCT01475461|147523444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.144||0.5133|TWO_SIDED|80.0|-0.18|0.19||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.19|-0.18|0.5133
73988823|NCT01475461|147523444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.15||0.1873|TWO_SIDED|80.0|-0.33|0.06||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.06|-0.33|0.1873
73988824|NCT01475461|147523444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.145||0.212|TWO_SIDED|80.0|-0.3|0.07||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.07|-0.30|0.2120
73988825|NCT01475461|147523444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.146||0.0001|TWO_SIDED|80.0|-0.73|-0.35||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.35|-0.73|0.0001
73988826|NCT01475461|147523444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.146||0.0021|TWO_SIDED|80.0|-0.61|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.23|-0.61|0.0021
73988827|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|2.87|STANDARD_ERROR_OF_MEAN|4.823||0.724|TWO_SIDED|80.0|-3.32|9.07||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||9.07|-3.32|0.7240
73988828|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.77|STANDARD_ERROR_OF_MEAN|4.952||0.3608|TWO_SIDED|80.0|-8.13|4.59||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.59|-8.13|0.3608
74039636|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0274|TWO_SIDED|95.0|1.03|1.71|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|1.03|0.0274
73875732|NCT02723773|147293528|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.74|||||TWO_SIDED|95.0|86.25|95.37|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||95.37|86.25|
73875733|NCT02723773|147293528|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.57|||||TWO_SIDED|95.0|86.66|96.24|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||96.24|86.66|
73875734|NCT02723773|147293528|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.45|||||TWO_SIDED|95.0|82.98|89.33|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||89.33|82.98|
73875735|NCT02723773|147293528|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.33|||||TWO_SIDED|95.0|79.91|87.93|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||87.93|79.91|
73988829|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|4.816||0.2511|TWO_SIDED|80.0|-9.42|2.95||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.95|-9.42|0.2511
73988830|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.28|STANDARD_ERROR_OF_MEAN|4.851||0.0673|TWO_SIDED|80.0|-13.51|-1.05||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-1.05|-13.51|0.0673
73988831|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.22|STANDARD_ERROR_OF_MEAN|4.843||0.0106|TWO_SIDED|80.0|-17.44|-5.0||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.00|-17.44|0.0106
73988832|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|5.138||0.4127|TWO_SIDED|80.0|-7.73|5.47||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.47|-7.73|0.4127
73988833|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|5.261||0.3604|TWO_SIDED|80.0|-8.64|4.87||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.87|-8.64|0.3604
73988834|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.35|STANDARD_ERROR_OF_MEAN|5.147||0.077|TWO_SIDED|80.0|-13.96|-0.74||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.74|-13.96|0.0770
73988835|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.79|STANDARD_ERROR_OF_MEAN|5.171||0.0451|TWO_SIDED|80.0|-15.43|-2.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.15|-15.43|0.0451
73988836|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|5.191||0.0001|TWO_SIDED|80.0|-26.57|-13.23||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-13.23|-26.57|0.0001
73988837|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|5.599||0.5783|TWO_SIDED|80.0|-6.08|8.3||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.30|-6.08|0.5783
73988838|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|5.785||0.3604|TWO_SIDED|80.0|-9.5|5.36||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.36|-9.50|0.3604
73988839|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.12|STANDARD_ERROR_OF_MEAN|5.636||0.0161|TWO_SIDED|80.0|-19.36|-4.88||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.88|-19.36|0.0161
74039637|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1206|TWO_SIDED|95.0|0.95|1.58|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.95|0.1206
73988840|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|5.663||0.2185|TWO_SIDED|80.0|-11.68|2.87||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.87|-11.68|0.2185
73988841|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.41|STANDARD_ERROR_OF_MEAN|5.649||0.0034|TWO_SIDED|80.0|-22.67|-8.16||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-8.16|-22.67|0.0034
73988842|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|6.387||0.5727|TWO_SIDED|80.0|-7.03|9.37||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||9.37|-7.03|0.5727
73988843|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|6.578||0.4961|TWO_SIDED|80.0|-8.51|8.38||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.38|-8.51|0.4961
73988844|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|6.411||0.2616|TWO_SIDED|80.0|-12.33|4.14||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.14|-12.33|0.2616
73988845|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|6.441||0.9197|TWO_SIDED|80.0|0.79|17.34||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||17.34|0.79|0.9197
73988846|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.76|STANDARD_ERROR_OF_MEAN|6.398||0.086|TWO_SIDED|80.0|-16.98|-0.54||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.54|-16.98|0.0860
73988847|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|6.476||0.5132|TWO_SIDED|80.0|-8.1|8.53||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.53|-8.10|0.5132
73988848|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|6.676||0.656|TWO_SIDED|80.0|-5.89|11.26||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.26|-5.89|0.6560
73988849|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|6.17|STANDARD_ERROR_OF_MEAN|6.496||0.8285|TWO_SIDED|80.0|-2.17|14.52||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||14.52|-2.17|0.8285
73988850|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|15.98|STANDARD_ERROR_OF_MEAN|6.527||0.9925|TWO_SIDED|80.0|7.59|24.36||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||24.36|7.59|0.9925
73988851|NCT01475461|147523445|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|6.487||0.601|TWO_SIDED|80.0|-6.67|10.0||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||10.00|-6.67|0.6010
73988852|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|0.449||0.0913|TWO_SIDED|80.0|0.18|1.34||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.34|0.18|0.0913
73988853|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.461||0.5236|TWO_SIDED|80.0|-0.3|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.89|-0.30|0.5236
73988854|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.447||0.9244|TWO_SIDED|80.0|-0.53|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|-0.53|0.9244
74089880|NCT02312713|147732638|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-2.86||||0.35|TWO_SIDED|95.0|-8.94|3.21|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for the 2 Minute Step Test.||3.21|-8.94|0.35
74089881|NCT02312713|147732638|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.01||||1|TWO_SIDED|95.0|-6.4|6.42|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for the 2 Minute Step Test.||6.42|-6.40|1.00
73988855|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.452||0.5066|TWO_SIDED|80.0|-0.28|0.88||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.88|-0.28|0.5066
73988856|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.449||0.8947|TWO_SIDED|80.0|-0.64|0.52||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.64|0.8947
73988857|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91|STANDARD_ERROR_OF_MEAN|0.478||0.0577|TWO_SIDED|80.0|0.3|1.52||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.52|0.30|0.0577
73988858|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.49||0.3012|TWO_SIDED|80.0|-0.12|1.14||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.14|-0.12|0.3012
73988859|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.476||0.3165|TWO_SIDED|80.0|-0.13|1.09||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.09|-0.13|0.3165
73988860|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.481||0.5191|TWO_SIDED|80.0|-0.31|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.31|0.5191
73988861|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.479||0.5107|TWO_SIDED|80.0|-0.3|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.30|0.5107
73988862|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.488||0.1054|TWO_SIDED|80.0|0.17|1.42||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.42|0.17|0.1054
73988863|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.502||0.5341|TWO_SIDED|80.0|-0.33|0.96||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.96|-0.33|0.5341
73988864|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.487||0.2782|TWO_SIDED|80.0|-0.1|1.15||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.15|-0.10|0.2782
73988865|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.492||0.5331|TWO_SIDED|80.0|-0.32|0.94||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.32|0.5331
73988866|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.489||0.907|TWO_SIDED|80.0|-0.57|0.68||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.68|-0.57|0.9070
73988867|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.512||0.1757|TWO_SIDED|80.0|0.04|1.35||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.35|0.04|0.1757
74089882|NCT02312713|147732639|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.19|TWO_SIDED|95.0|-1.56|0.3|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Unilateral Stand Time.||0.30|-1.56|0.19
73875736|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.68|||||TWO_SIDED|95.0|93.07|99.53|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 1.||99.53|93.07|
73875737|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|96.76|||||TWO_SIDED|95.0|80.57|99.92|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 1.||99.92|80.57|
73988868|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.527||0.4083|TWO_SIDED|80.0|-0.24|1.11||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.11|-0.24|0.4083
73988869|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.511||0.315|TWO_SIDED|80.0|-0.14|1.17||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.17|-0.14|0.3150
73988870|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.516||0.6631|TWO_SIDED|80.0|-0.44|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.89|-0.44|0.6631
73988871|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.512||0.8694|TWO_SIDED|80.0|-0.74|0.57||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.57|-0.74|0.8694
73988872|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.545||0.2031|TWO_SIDED|80.0|0.0|1.4||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.40|0.00|0.2031
73988873|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.563||0.7137|TWO_SIDED|80.0|-0.52|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.52|0.7137
73988874|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.545||0.681|TWO_SIDED|80.0|-0.48|0.92||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.92|-0.48|0.6810
73988875|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.55||0.6921|TWO_SIDED|80.0|-0.92|0.49||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.49|-0.92|0.6921
73988876|NCT01475461|147523452|SUPERIORITY_OR_OTHER||LS Mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.545||0.3702|TWO_SIDED|80.0|-1.19|0.21||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.21|-1.19|0.3702
73988877|NCT03214250|147523498|SUPERIORITY|One-sided|probability|0.577||||0.006|ONE_SIDED|95.0|0.417|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.417|0.006
73988878|NCT03214250|147523498|SUPERIORITY|One-sided|probability|0.481||||0.062|ONE_SIDED|95.0|0.337|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.337|0.062
73988879|NCT03214250|147523498|SUPERIORITY|One-sided|probability|0.413||||0.233|ONE_SIDED|95.0|0.27|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.270|0.233
73988880|NCT00594178|147523510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-250.8||||0.318|TWO_SIDED|95.0|-778.87|277.21|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise lean muscle mass.||277.21|-778.87|.318
73988881|NCT00594178|147523511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0645||||0.011|TWO_SIDED|95.0|0.01827|0.11073|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise bone density.||.11073|.01827|.011
74039638|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0365|TWO_SIDED|95.0|1.02|1.69|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.69|1.02|0.0365
74039639|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0964|TWO_SIDED|95.0|0.96|1.71|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|0.96|0.0964
73875738|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|79.32|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 1.||100.00|79.32|
73988882|NCT02971228|147523518|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|-6.9||||0.2518|TWO_SIDED|95.0|-19.63|5.84|||t-test, 2 sided||The estimated mean difference is based on the difference between the mean values for 10 patients in the ZP4207 group (12.78) and the matching 10 patients in the Lilly glucagon group (19.67)|A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||5.84|-19.63|0.2518
73988883|NCT02971228|147523518|OTHER||Median Difference (Final Values)|-8.02||||0.25|TWO_SIDED|95.0|-25.85|10.68|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||10.68|-25.85|0.2500
73988884|NCT02971228|147523519|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|-0.28||||0.8508|TWO_SIDED|95.0|-3.55|2.99|||t-test, 2 sided|||A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||2.99|-3.55|0.8508
73988885|NCT02971228|147523519|OTHER||Median Difference (Final Values)|0.03|||>|0.9999|TWO_SIDED|95.0|-4.12|3.13|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||3.13|-4.12|>0.9999
73988886|NCT02971228|147523520|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|0.63||||0.1847|TWO_SIDED|95.0|-0.36|1.62|||t-test, 2 sided|||A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||1.62|-0.36|0.1847
73988887|NCT02971228|147523520|OTHER||Median Difference (Final Values)|0.02||||0.0781|TWO_SIDED|95.0|-0.01|3.09|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||3.09|-0.01|0.0781
73988888|NCT02561806|147523550|NON_INFERIORITY|Non-inferiority margin was -12.6% for 97.5% confidence interval|Risk Difference (RD)|0.321|||<|0.001|TWO_SIDED|97.5|0.198|0.445|||Regression, Logistic|||||0.445|0.198|<0.001
73988889|NCT02561806|147523551|SUPERIORITY||Risk Ratio (RR)|1.285|||<|0.001|TWO_SIDED|95.0|1.13|1.439|||Regression, Logistic|||||1.439|1.130|<0.001
73988890|NCT02561806|147523552|SUPERIORITY||Risk Ratio (RR)|2.699||||0.009|TWO_SIDED|95.0|1.423|3.975|||Regression, Logistic|||||3.975|1.423|0.009
73988891|NCT02561806|147523553|SUPERIORITY||Risk Ratio (RR)|1.469|||<|0.001|TWO_SIDED|95.0|1.244|1.695|||Regression, Logistic|||||1.695|1.244|<0.001
73988892|NCT02561806|147523554|SUPERIORITY||Risk Ratio (RR)|3.421||||0.021|TWO_SIDED|95.0|1.353|5.488|||Regression, Logistic|||||5.488|1.353|0.021
73988893|NCT02561806|147523561|SUPERIORITY||Risk Ratio (RR)|1.391||||0.012|TWO_SIDED|95.0|1.085|1.698|||Regression, Logistic|||||1.698|1.085|0.012
73988894|NCT02547441|147523574|SUPERIORITY|||||||0.043|||||||ANCOVA|||||||0.043
73988895|NCT02547441|147523575|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|||||||0.019
73988896|NCT01322009|147523584|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Analysis run over study period but data entered only for the 6 h time point||||||>0.05
74009207|NCT00397033|147569184|SUPERIORITY_OR_OTHER||LS Means Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.7||0.187||95.0|-9.0|1.8||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER low dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.||1.8|-9.0|0.187
73988897|NCT00241969|147523603|SUPERIORITY|Some data were missing for energy intake (n=3 baseline, n=13 post-treatment), thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measure factor.|maximum likelihood estimation|431.0|||<|0.001|TWO_SIDED|95.0|282.0|581.0|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Some data were missing for energy intake (N = 3 baseline; 13 post treatment), and thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measures factor, no group main effect at baseline for energy intake, and sex, baseline Pseudomonas aeruginosa status, and treatment modality as covariates in the statistical model. This model is similar to an analysis of covariance model with baseline energy intake included as an additional covariate, but the PROC MIXED model employs maximum likelihood estimation and consequently allows for data to be missing at random. The test of the time by group interaction within this PROC MIXED model indicated whether the behavioral and nutrition treatment was efficacious relative to our control treatment.|581|282|<0.001
73988898|NCT00241969|147523604|SUPERIORITY|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.09||||0.25|TWO_SIDED|95.0|-0.06|0.24|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.|0.24|-0.06|0.25
73988899|NCT00241969|147523605|SUPERIORITY|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.14||||0.049|TWO_SIDED|95.0|0.001|0.27|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ and HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.|0.27|0.001|0.049
73988900|NCT00582114|147523621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36||||0.001|TWO_SIDED|95.0|1.36|4.23|||Mixed Models Analysis|||Cardiovascular events were counted by subject and included the following: myocardial infarction, stroke, hospitalization for congestive heart failure, hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).||4.23|1.36|0.001
73988901|NCT00582114|147523621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.29||||0.02|TWO_SIDED|95.0|1.07|5.21|||Mixed Models Analysis|||As a post hoc analysis, we determined the narrower definition of cardiovascular events per group that included myocardial infarction, stroke, congestive heart failure or cardiovascular death. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).||5.21|1.07|0.02
73988902|NCT00582114|147523621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.13||||0.02|TWO_SIDED|95.0|1.08|10.99|||Mixed Models Analysis|||Hospitalization for congestive heart failure between groups was analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.||10.99|1.08|0.02
73956535|NCT00708097|147449050|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1813.29|||<|0.0001|TWO_SIDED|95.0|1503.03|2123.54||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||2123.54|1503.03|<0.0001
73956536|NCT00708097|147449050|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|589.61||||0.0002|TWO_SIDED|95.0|285.31|893.92|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||893.92|285.31|0.0002
73988903|NCT00582114|147523621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.61||||0.002|TWO_SIDED|95.0|1.18|2.19|||Mixed Models Analysis|||All-cause hospitalizations between groups were analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.||2.19|1.18|0.002
73988904|NCT02604342|147523622|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.33|||Stratified log-rank test||Estimated hazard ratio obtained from stratified Cox model with treatment group as covariate.|||0.33|0.12|<0.001
73956537|NCT00708097|147449050|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|651.57|||<|0.0001|TWO_SIDED|95.0|346.44|956.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||956.70|346.44|<0.0001
73988905|NCT02604342|147523623|SUPERIORITY||Difference in C-ORR|0.667|||<|0.001|TWO_SIDED|95.0|0.39|0.86|||Chi-squared|||95% confidence interval of the difference (alectinib - chemotherapy) computed using Hauck-Anderson approach.||0.86|0.39|<0.001
73988906|NCT00130728|147523646|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.7583||95.0|0.799|1.177||relative to placebo arm|Log Rank||Stratified analysis; Hazard ratio is relative to placebo arm.|||1.177|0.799|0.7583
73988907|NCT00130728|147523647|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.623|||<|0.0001||95.0|0.519|0.748||relative to placebo arm|Log Rank||Stratified analysis; hazard ratio is relative to placebo arm.|||0.748|0.519|<.0001
73988908|NCT00130728|147523648|SUPERIORITY_OR_OTHER_LEGACY||Percentage difference|6.4||||0.0068||95.0|1.8|11.3||Relative to placebo arm|Mantel Haenszel||Difference in objective response rates relative to placebo arm|||11.3|1.8|0.0068
73988909|NCT00746356|147523651|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0066|STANDARD_DEVIATION|0.3103|<|0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used, and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|<0.0001
73988910|NCT00746356|147523652|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0625|STANDARD_DEVIATION|0.0948||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
73988911|NCT00746356|147523653|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0556|STANDARD_DEVIATION|0.0824||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met, a value of 2.5% were used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
73988912|NCT00746356|147523654|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0028|STANDARD_DEVIATION|0.2852||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
73988913|NCT03181282|147523665|SUPERIORITY||Slope|0.0529|STANDARD_ERROR_OF_MEAN|0.0194||0.0194|TWO_SIDED|95.0|0.0132|0.0925|||Mixed Models Analysis|Mixed model analysis with repeated measures.||This analysis is for the On Medication / On Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||0.0925|0.0132|0.0194
73988914|NCT03181282|147523665|SUPERIORITY||Slope|0.0718|STANDARD_ERROR_OF_MEAN|0.0231||0.004625|TWO_SIDED|95.0|0.0242|0.1194|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the Off Medication / Off Stimulation Condition. Age was controlled for in the analysis given the baseline difference in age between groups.||0.1194|0.0242|0.004625
73988915|NCT03181282|147523666|SUPERIORITY||Slope|10.5248|STANDARD_ERROR_OF_MEAN|4.8439||0.038389|TWO_SIDED|95.0|0.6038|20.4459|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the On Medication / On Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||20.4459|0.6038|0.038389
73988916|NCT03181282|147523666|SUPERIORITY||Slope|7.7233|STANDARD_ERROR_OF_MEAN|4.668||0.109873|TWO_SIDED|95.0|-1.8652|17.3117|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the Off Medication / Off Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||17.3117|-1.8652|0.109873
74039640|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2515|TWO_SIDED|95.0|0.89|1.59|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.89|0.2515
74039641|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8122|TWO_SIDED|95.0|0.66|1.71|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|0.66|0.8122
73988917|NCT00092521|147523712|SUPERIORITY_OR_OTHER||Percent relative risk reduction|100.0||||||95.0|95.1|100.0|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter|||100|95.1|
73988918|NCT00092521|147523713|SUPERIORITY_OR_OTHER||Percent relative risk reduction|100.0||||||95.0|94.9|100.0|||||CI based on binomial tail probabilities and not from a dispersion parameter|||100|94.9|
73988919|NCT04260464|147523728|OTHER||Test/Reference Ratio|110.15|||||TWO_SIDED|95.0|83.76|144.86||||||Analysis of variance (ANOVA) was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||144.86|83.76|
73988920|NCT04260464|147523728|OTHER||Test/Reference Ratio|94.58|||||TWO_SIDED|90.0|55.84|160.19||||||ANOVA was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||160.19|55.84|
73988921|NCT04260464|147523728|OTHER||Test/Reference Ratio|124.2|||||TWO_SIDED|90.0|100.24|153.89||||||ANOVA was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||153.89|100.24|
73988922|NCT04260464|147523729|OTHER||Test/Reference Ratio|112.08|||||TWO_SIDED|95.0|60.85|206.45||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||206.45|60.85|
73988923|NCT04260464|147523729|OTHER||Test/Reference Ratio|70.97|||||TWO_SIDED|90.0|27.6|182.49||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||182.49|27.60|
73988924|NCT04260464|147523729|OTHER||Test/Reference Ratio|147.7|||||TWO_SIDED|90.0|75.17|290.21||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||290.21|75.17|
73988925|NCT04260464|147523730|OTHER||Test/Reference Ratio|177.53|||||TWO_SIDED|95.0|135.82|232.04||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||232.04|135.82|
73988926|NCT04260464|147523730|OTHER||Test/Reference Ratio|132.69|||||TWO_SIDED|90.0|95.08|185.17||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||185.17|95.08|
73988927|NCT04260464|147523730|OTHER||Test/Reference Ratio|122.04|||||TWO_SIDED|90.0|84.47|176.3||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||176.30|84.47|
73988928|NCT04260464|147523731|OTHER||Test/Reference Ratio|445.99|||||TWO_SIDED|95.0|326.55|609.13||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||609.13|326.55|
73988929|NCT04260464|147523731|OTHER||Test/Reference Ratio|144.63|||||TWO_SIDED|90.0|112.76|185.5||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||185.50|112.76|
73988930|NCT04260464|147523731|OTHER||Test/Reference Ratio|229.12|||||TWO_SIDED|90.0|189.97|276.35||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||276.35|189.97|
73988931|NCT03469492|147523737|SUPERIORITY|||||||0.006|||||||Regression, Linear|||||||0.006
73988932|NCT03469492|147523741|SUPERIORITY|||||||0.266|||||||Mixed Models Analysis|||||||0.266
74035020|NCT00755846|147622417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.689||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.689
73988933|NCT03469492|147523744|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
73988934|NCT03469492|147523745|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
73988935|NCT02806505|147523755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.6746|TWO_SIDED|95.0|0.49|3.06||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||3.06|0.49|0.6746
73988936|NCT02806505|147523756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.3923|TWO_SIDED|95.0|0.6|3.76||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||3.76|0.60|0.3923
73988937|NCT02806505|147523757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8843|TWO_SIDED|95.0|0.43|2.68||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 12: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||2.68|0.43|0.8843
73988938|NCT02806505|147523757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.5866|TWO_SIDED|95.0|0.28|2.04||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 24: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||2.04|0.28|0.5866
73988939|NCT02161406|147523775|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||||||0.28
73988940|NCT02161406|147523776|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|||||||0.73
73988941|NCT02161406|147523777|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
73988942|NCT02161406|147523778|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
73988943|NCT02161406|147523779|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
73988944|NCT02161406|147523780|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
73988945|NCT02161406|147523781|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
73988946|NCT02161406|147523782|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.34
73988947|NCT02161406|147523783|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
73988948|NCT02161406|147523784|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
73988949|NCT02161406|147523785|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
73988950|NCT02161406|147523786|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.37
73988951|NCT02161406|147523787|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.55
74035021|NCT00755846|147622417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.742||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.742
74039642|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1848|TWO_SIDED|95.0|0.86|2.13|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.13|0.86|0.1848
74039643|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2622|TWO_SIDED|95.0|0.9|1.49|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.90|0.2622
73988952|NCT02161406|147523788|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
73988953|NCT02161406|147523789|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
73988954|NCT02161406|147523790|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||||||0.81
73988955|NCT02161406|147523791|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
73988956|NCT02161406|147523792|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
73988957|NCT02161406|147523793|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
73988958|NCT02161406|147523794|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
73988959|NCT02161406|147523795|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
73988960|NCT02161406|147523796|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
73988961|NCT02161406|147523797|SUPERIORITY|||||||0.03|||||||van Elteren test|The van Elteren test adjusted for duration of dcSSc. Multiple imputation was used to address missing follow-up data in 5 components of CRISS.||||||0.03
73988962|NCT02161406|147523798|SUPERIORITY|||||||0.1769|||||||Mixed Models Analysis|||||||0.1769
73988963|NCT02161406|147523799|SUPERIORITY|||||||0.9075|||||||Mixed Models Analysis|||||||0.9075
73988964|NCT02161406|147523800|SUPERIORITY|||||||0.5831|||||||Mixed Models Analysis|||||||0.5831
73988965|NCT02161406|147523801|SUPERIORITY|||||||0.0193|||||||Mixed Models Analysis|||||||0.0193
73988966|NCT02161406|147523802|SUPERIORITY|||||||0.0097|||||||Mixed Models Analysis|||||||0.0097
73988967|NCT02161406|147523803|SUPERIORITY|||||||0.0751|||||||Mixed Models Analysis|||||||0.0751
73988968|NCT02161406|147523804|SUPERIORITY|||||||0.4927|||||||Mixed Models Analysis|||||||0.4927
73988969|NCT02161406|147523805|SUPERIORITY|||||||0.1604|||||||Mixed Models Analysis|||||||0.1604
73988970|NCT02161406|147523806|SUPERIORITY|||||||0.7281|||||||Mixed Models Analysis|||||||0.7281
73988971|NCT02161406|147523807|SUPERIORITY|||||||0.1679|||||||Mixed Models Analysis|||||||0.1679
73988972|NCT02161406|147523808|SUPERIORITY|||||||0.2906|||||||Mixed Models Analysis|||||||0.2906
73988973|NCT02034162|147523887|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
73988974|NCT02034162|147523888|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
73988975|NCT02034162|147523890|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73988976|NCT02034162|147523891|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
73988977|NCT01343251|147523922|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Chi-squared|||||||0.48
73988978|NCT01343251|147523923|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
73988979|NCT01343251|147523924|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||SF-36 Test 1 Total Score|t-test, 2 sided|||||||0.49
73988980|NCT01343251|147523924|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||SF-36 Test 2 Total Score|t-test, 2 sided|||||||0.91
73988981|NCT01343251|147523924|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||SF-36 Test 3 Total Score|t-test, 2 sided|||||||0.67
73988982|NCT01343251|147523924|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||SF-36 Test 4 Total Score|t-test, 2 sided|||||||<0.001
73988983|NCT01343251|147523925|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Chi-squared|||||||0.04
73988984|NCT01343251|147523926|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Chi-squared|||||||0.90
73988985|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|-2.6||||0.887|TWO_SIDED|90.0|-6.2|1.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 2||1.0|-6.2|0.887
73988986|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|0.3||||0.431|TWO_SIDED|90.0|-2.6|3.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 2||3.2|-2.6|0.431
73988987|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|-1.0||||0.647|TWO_SIDED|90.0|-5.4|3.4|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||3.4|-5.4|0.647
73988988|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|2.4||||0.13|TWO_SIDED|90.0|-1.1|6.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||6.0|-1.1|0.130
73988989|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|-2.5||||0.818|TWO_SIDED|90.0|-6.9|2.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates|Day 15||2.0|-6.9|0.818
73988990|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|0.3||||0.457|TWO_SIDED|90.0|-3.6|4.1|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 15||4.1|-3.6|0.457
73988991|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|-3.1||||0.906|TWO_SIDED|90.0|-6.9|0.8|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||0.8|-6.9|0.906
73988992|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|-0.4||||0.566|TWO_SIDED|90.0|-4.1|3.3|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||3.3|-4.1|0.566
73988993|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|-1.3||||0.686|TWO_SIDED|90.0|-5.6|3.1|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||3.1|-5.6|0.686
73988994|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|1.4||||0.28|TWO_SIDED|90.0|-2.5|5.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||5.2|-2.5|0.280
73988995|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|-2.4||||0.849|TWO_SIDED|90.0|-6.3|1.4|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.4|-6.3|0.849
73988996|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|1.5||||0.254|TWO_SIDED|90.0|-2.2|5.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||5.2|-2.2|0.254
73988997|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|-2.7||||0.866|TWO_SIDED|90.0|-6.6|1.3|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.3|-6.6|0.866
73988998|NCT03927690|147523964|SUPERIORITY||Difference (Test vs Reference)|2.0||||0.198|TWO_SIDED|90.0|-1.9|5.8|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||5.8|-1.9|0.198
73875739|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.97|||||TWO_SIDED|95.0|92.46|99.76|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 1.||99.76|92.46|
73988999|NCT03927690|147523970|SUPERIORITY||Ratio (Test vs Reference)|1.2||||0.998|TWO_SIDED|90.0|1.08|1.33|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||1.33|1.08|0.998
73989000|NCT03927690|147523970|SUPERIORITY||Ratio (Test vs Reference)|1.0||||0.527|TWO_SIDED|90.0|0.92|1.09|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||1.09|0.92|0.527
73989001|NCT03927690|147523970|SUPERIORITY||Ratio (Test vs Reference)|1.21||||0.999|TWO_SIDED|90.0|1.1|1.33|||Mixed model repeated measures analysis||Comparison of model-based mean estimates|Day 15||1.33|1.10|0.999
74039644|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1579|TWO_SIDED|95.0|0.93|1.54|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.54|0.93|0.1579
73989002|NCT03927690|147523970|SUPERIORITY||Ratio (Test vs Reference)|1.03||||0.716|TWO_SIDED|90.0|0.95|1.12|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 15||1.12|0.95|0.716
73989003|NCT03927690|147523970|SUPERIORITY||Ratio (Test vs Reference)|1.21||||1|TWO_SIDED|90.0|1.13|1.31|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||1.31|1.13|1.000
73989004|NCT03927690|147523970|SUPERIORITY||Ratio (Test vs Reference)|0.98||||0.281|TWO_SIDED|90.0|0.91|1.05|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||1.05|0.91|0.281
73989005|NCT03927690|147523970|SUPERIORITY||Ratio (Test vs Reference)|1.32||||1|TWO_SIDED|90.0|1.2|1.46|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||1.46|1.20|1.000
73989006|NCT03927690|147523970|SUPERIORITY||Ratio (Test vs Reference)|0.96||||0.2|TWO_SIDED|90.0|0.88|1.04|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||1.04|0.88|0.200
73989007|NCT03927690|147523970|SUPERIORITY||Ratio (Test vs Reference)|1.18||||1|TWO_SIDED|90.0|1.09|1.28|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.28|1.09|1.000
73989008|NCT03927690|147523970|SUPERIORITY||Ratio (Test vs Reference)|0.94||||0.083|TWO_SIDED|90.0|0.87|1.01|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.01|0.87|0.083
73989009|NCT03927690|147523970|SUPERIORITY||Ratio(Test vs Reference)|1.26||||1|TWO_SIDED|90.0|1.14|1.38|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.38|1.14|1.000
73989010|NCT03927690|147523970|SUPERIORITY||Ratio(Test vs Reference)|0.96||||0.254|TWO_SIDED|90.0|0.88|1.06|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.06|0.88|0.254
73989011|NCT00337285|147523989|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||< 0.0001
73989012|NCT00337285|147523991|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||< 0.0001
73989013|NCT00553605|147523997|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 2-sided 95% CI of the treatment difference (parecoxib - ketoprofen) was greater than -10 mm.|Least-squares (LS) mean difference|-1.12|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|95.0|-6.53|4.3||||||LS mean difference and 95 percent (%) confidence interval (CI) were based on analysis of covariance (ANCOVA) model with terms for treatment group and country, and baseline as covariates.||4.30|-6.53|
73989014|NCT00553605|147523998|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|2.52||0.972|TWO_SIDED|95.0|-5.04|4.86|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||4.86|-5.04|0.972
73989015|NCT00553605|147524000|SUPERIORITY_OR_OTHER||LS mean difference|0.75|STANDARD_ERROR_OF_MEAN|2.56||0.768|TWO_SIDED|95.0|-4.28|5.79|||ANCOVA|||Minute 15: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||5.79|-4.28|0.768
73989016|NCT00553605|147524000|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|2.91||0.866|TWO_SIDED|95.0|-6.22|5.24|||ANCOVA|||Minute 30: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||5.24|-6.22|0.866
73989017|NCT00553605|147524000|SUPERIORITY_OR_OTHER||LS mean difference|0.94|STANDARD_ERROR_OF_MEAN|2.7||0.729|TWO_SIDED|95.0|-4.38|6.26|||ANCOVA|||Minute 45: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||6.26|-4.38|0.729
73989018|NCT00553605|147524000|SUPERIORITY_OR_OTHER||LS mean difference|2.62|STANDARD_ERROR_OF_MEAN|2.47||0.29|TWO_SIDED|95.0|-2.24|7.48|||ANCOVA|||Minute 60: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||7.48|-2.24|0.290
73956538|NCT00708097|147449050|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1827.19|||<|0.0001|TWO_SIDED|95.0|1519.78|2134.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||2134.60|1519.78|<0.0001
73956539|NCT00708097|147449050|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|61.96||||0.6874|TWO_SIDED|95.0|-241.25|365.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||365.17|-241.25|0.6874
73956540|NCT00708097|147449050|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1237.58|||<|0.0001|TWO_SIDED|95.0|931.46|1543.7|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||1543.70|931.46|<0.0001
73956541|NCT00708097|147449050|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1175.62|||<|0.0001|TWO_SIDED|95.0|869.15|1482.1||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||1482.10|869.15|<0.0001
73956542|NCT01451814|147449051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.22|TWO_SIDED|95.0|0.67|5.48|||Chi-squared|||||5.48|0.67|.22
73956543|NCT01451814|147449052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3||||0.06|TWO_SIDED|95.0|0.84|22.1|||Chi-squared|||||22.1|0.84|.06
73956544|NCT01451814|147449053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0||||0.18|TWO_SIDED|95.0|0.56|16.11|||Chi-squared|||||16.11|0.56|.18
73956545|NCT02467491|147449095|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score at baseline was compared with the SPPB scored after 4 weeks of physical activity intervention with a paired t-test||||0.04
73956546|NCT02467491|147449096|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score after 4 weeks of physical activity intervention was compared with the SPPB score after 2 to 3 months from the completion of the physical activity intervention with a paired t-test||||0.02
73956547|NCT03107611|147449097|SUPERIORITY|||||||0.0817|||||||Fisher Exact|||||||0.0817
73956548|NCT03107611|147449097|SUPERIORITY|||||||0.2874|||||||Fisher Exact|||||||0.2874
73956549|NCT03107611|147449098|EQUIVALENCE|Equivalence margin: -0.20, +0.20|Difference in proportions|-0.03|||||TWO_SIDED|90.0|-0.12|0.06||||||||0.06|-0.12|
73956550|NCT01720446|147449101|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of semaglutide versus placebo was considered to be confirmed if the upper limit of the two-sided 95% CI for the HR was below 1.8 or equivalent if the p-value for the one-sided test of: H0: HR ≥ 1.8 against Ha: HR \<1.8 was less than 2.5% (or equivalent to 5% for a two-sided test).|Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of non-inferiority with limit 1.8.|Regression, Cox||Semaglutide/Placebo|The primary endpoint was analysed using a stratified Cox proportional hazards model with treatment group (semaglutide, placebo) as fixed factor. Assuming the same population MACE risk for the semaglutide and placebo groups (i.e., the population hazards ratio \[HR\] equals 1), a total minimum of 122 events were needed in order to have at least 90% power to ascertain that the upper two-sided 95% confidence limit for the HR was less than 1.8.||0.95|0.58|<0.0001
73956551|NCT01720446|147449101|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0167|TWO_SIDED|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of no difference.|Regression, Cox||Semaglutide/Placebo|A post hoc analysis of superiority of semaglutide versus placebo was performed based on the pre-specified Cox proportional hazard analysis using the two-sided Wald test of no difference, with treatment (semaglutide, placebo) as fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.95|0.58|0.0167
73956552|NCT01720446|147449102|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0016|TWO_SIDED|95.0|0.62|0.89|||Regression, Cox||Semaglutide/Placebo|Analysis was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.89|0.62|0.0016
73956553|NCT01720446|147449103|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.9181|TWO_SIDED|95.0|0.65|1.48|||Regression, Cox||Semaglutide/Placebo|Analysis for CV death was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.48|0.65|0.9181
73956554|NCT01720446|147449103|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.1194|TWO_SIDED|95.0|0.51|1.08|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal myocardial infarction was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.08|0.51|0.1194
73875740|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.57|||||TWO_SIDED|95.0|90.96|99.71|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 1.||99.71|90.96|
73875741|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.69|||||TWO_SIDED|95.0|86.15|96.57|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 2.||96.57|86.15|
73875742|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.66|||||TWO_SIDED|95.0|70.78|99.15|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 2.||99.15|70.78|
73875743|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|95.49|||||TWO_SIDED|95.0|72.11|99.89|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 2.||99.89|72.11|
73875744|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.71|||||TWO_SIDED|95.0|85.13|96.93|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 2.||96.93|85.13|
73989019|NCT00553605|147524000|SUPERIORITY_OR_OTHER||LS mean difference|2.16|STANDARD_ERROR_OF_MEAN|2.14||0.314|TWO_SIDED|95.0|-2.05|6.37|||ANCOVA|||Minute 90: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||6.37|-2.05|0.314
73989020|NCT00553605|147524000|SUPERIORITY_OR_OTHER||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|1.72||0.926|TWO_SIDED|95.0|-3.23|3.55|||ANCOVA|||Minute 120: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||3.55|-3.23|0.926
73989021|NCT00553605|147524001|SUPERIORITY_OR_OTHER||LS mean difference|10.13|STANDARD_ERROR_OF_MEAN|13.43||0.451|TWO_SIDED|95.0|-16.3|36.54|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country as covariates.||36.54|-16.3|0.451
73989022|NCT00553605|147524002|SUPERIORITY_OR_OTHER|||||||0.3982|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.3982
73989023|NCT00553605|147524002|SUPERIORITY_OR_OTHER|||||||0.5552|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.5552
73989024|NCT00553605|147524003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.007||||0.9785|TWO_SIDED|95.0|0.6|1.69|||Regression, Logistic|||p-value was based on logistic regression model with terms for treatment group and baseline as covariates.||1.69|0.60|0.9785
73989025|NCT00553605|147524004|SUPERIORITY_OR_OTHER|||||||0.2482|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.2482
73989026|NCT00553605|147524004|SUPERIORITY_OR_OTHER|||||||0.7659|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.7659
73989027|NCT00553605|147524005|SUPERIORITY_OR_OTHER|||||||0.9783|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.9783
74035022|NCT00755846|147622417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.11||0.22||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.220
74039645|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2773|TWO_SIDED|95.0|0.89|1.49|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.89|0.2773
73989028|NCT00553605|147524005|SUPERIORITY_OR_OTHER|||||||0.6847|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.6847
73989029|NCT00553605|147524006|SUPERIORITY_OR_OTHER|||||||0.9645|TWO_SIDED||||||Log Rank|||||||0.9645
73989030|NCT01376050|147524013|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
73989031|NCT01376050|147524014|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
73989032|NCT03463577|147524027|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.38|||||TWO_SIDED|98.75|1.21|1.58|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted relative risk (RR) for pre-eclampsia and eclampsia in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||1.58|1.21|
73989033|NCT03463577|147524027|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.28|||||TWO_SIDED|98.75|1.12|1.47|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted RR for intra-uterine infections (chorioamnionitis and endometritis) in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||1.47|1.12|
73989034|NCT03463577|147524028|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|0.71|||||TWO_SIDED|98.75|0.64|0.78|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted RR for preterm delivery in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||0.78|0.64|
73989035|NCT03463577|147524029|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.04|||||TWO_SIDED|98.75|0.94|1.16|||||Adjusted RR with 98.75% CI-Poisson regression model|Demonstration of adjusted RR for small for gestational age in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was less than 2 (non-inferiority testing).||1.16|0.94|
73989036|NCT03463577|147524030|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.7|0.98|||||Adjusted RR with 95% CI -Poisson regression model|Assessment of adjusted RR for poor fetal growth in the Exposed pregnant women cohort (on or after 1st day of 27th week of pregnancy) compared to the Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.98|0.70|
73989037|NCT03463577|147524030|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.99|1.72|||||Adjusted RR with 95% CI - Poisson regression model|Assessment of adjusted RR for placental abortion in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||1.72|0.99|
73989038|NCT03463577|147524030|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.64|0.91|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for preterm pre-labor rupture of membranes in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.91|0.64|
73989039|NCT03463577|147524031|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR =1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.38|||||TWO_SIDED|95.0|0.22|0.67|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for stillbirth/fetal death in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.67|0.22|
73989040|NCT03463577|147524031|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.86|1.33|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for transfusion during delivery hospitalization in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||1.33|0.86|
74089883|NCT02312713|147732639|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.93|TWO_SIDED|95.0|-0.89|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Unilateral Stand Time.||0.98|-0.89|0.93
73875745|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.01|||||TWO_SIDED|95.0|82.82|96.88|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 2.||96.88|82.82|
73875746|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.36|||||TWO_SIDED|95.0|84.98|96.59|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 3.||96.59|84.98|
73875747|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|89.2|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 3.||100.00|89.20|
73989041|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.38|1.73|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for neonatal death in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.73|0.38|
73989042|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.35|||||TWO_SIDED|95.0|0.81|2.24|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of nervous system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.24|0.81|
73989043|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|1.06|1.29|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of eye in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.29|1.06|
73989044|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|2.02|||||TWO_SIDED|95.0|1.59|2.55|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of ear, face or neck in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing.||2.55|1.59|
73989045|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.96|1.31|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of cardiovascular system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infant cohort was 1 or differed from 1 (superiority testing).||1.31|0.96|
73989046|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.34|||||TWO_SIDED|95.0|1.07|1.68|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of respiratory system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was1 or differed from 1 (superiority testing).||1.68|1.07|
73989047|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.41||||||95.0|0.78|2.57|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for clefts in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.57|0.78|
74009208|NCT00397033|147569185|SUPERIORITY_OR_OTHER||LS Means Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-1.1|-0.4|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher Scores indicate worsening.|||-0.4|-1.1|<0.001
73989048|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.75|||||TWO_SIDED|95.0|1.57|1.95|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of upper gastrointestinal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.95|1.57|
73989049|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.63|||||TWO_SIDED|95.0|0.36|1.12|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of lower gastrointestinal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.12|0.36|
73989050|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|1.01|1.42|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of genital organs in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.42|1.01|
73989051|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.4|||||TWO_SIDED|95.0|1.04|1.88|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of renal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing.||1.88|1.04|
73989052|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.5||||||95.0|1.21|1.86|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of musculoskeletal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.86|1.21|
73989053|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.85|1.52|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of limb in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.52|0.85|
73989054|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.98|||||TWO_SIDED|95.0|1.76|2.23|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of integument in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.23|1.76|
73989055|NCT03463577|147524032|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.64|1.85|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for other and unspecified congenital anomalies in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.85|0.64|
74035023|NCT00755846|147622417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.05||0.348||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.348
74035024|NCT00755846|147622417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.06||0.627||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.627
73956555|NCT01720446|147449103|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0438|TWO_SIDED|95.0|0.38|0.99|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.99|0.38|0.0438
73956556|NCT01720446|147449103|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0027|TWO_SIDED|95.0|0.5|0.86|||Regression, Cox||Semaglutide/Placebo|Analysis for revascularisation was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.86|0.50|0.0027
73956557|NCT01720446|147449103|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.4914|TWO_SIDED|95.0|0.47|1.44|||Regression, Cox||Semaglutide/Placebo|Analysis for 'unstable angina requiring hospitalisation' was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.44|0.47|0.4914
73956558|NCT01720446|147449103|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5735|TWO_SIDED|95.0|0.77|1.61|||Regression, Cox||Semaglutide/Placcbo|Analysis for hospitalisation for heart failure was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.61|0.77|0.5735
73956559|NCT01720446|147449104|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0292|TWO_SIDED|95.0|0.61|0.97|||Regression, Cox||Semaglutide/Placebo|Analysis for all-cause death, non-fatal MI or non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.97|0.61|0.0292
73956560|NCT01720446|147449105|SUPERIORITY_OR_OTHER||Treatment difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.52|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.52|-0.80|<0.0001
73956561|NCT01720446|147449105|SUPERIORITY_OR_OTHER||Treatment difference|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.91|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.91|-1.19|<0.0001
73956562|NCT01720446|147449106|SUPERIORITY_OR_OTHER||Treatment difference|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.38|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.38|-1.06|<0.0001
73956563|NCT01720446|147449106|SUPERIORITY_OR_OTHER||Treatment difference|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.56|-0.88|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.88|-1.56|<0.0001
73956564|NCT01720446|147449107|SUPERIORITY_OR_OTHER||Treatment difference|-2.95|||<|0.0001|TWO_SIDED|95.0|-3.47|-2.44|||Mixed Models Analysis||Sema 0.5 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-2.44|-3.47|<0.0001
73956565|NCT01720446|147449107|SUPERIORITY_OR_OTHER||Treatment difference|-4.27|||<|0.0001|TWO_SIDED|95.0|-4.78|-3.75|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-3.75|-4.78|<0.0001
73956566|NCT01720446|147449108|SUPERIORITY_OR_OTHER||Treatment ratio|0.97||||0.0149|TWO_SIDED|95.0|0.95|1.0|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||1.00|0.95|0.0149
73956567|NCT01720446|147449108|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.258|TWO_SIDED|95.0|0.97|1.01|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||1.01|0.97|0.2580
73956568|NCT01720446|147449108|SUPERIORITY_OR_OTHER||Treatment ratio|1.0||||0.8106|TWO_SIDED|95.0|0.99|1.02|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.02|0.99|0.8106
73956569|NCT01720446|147449108|SUPERIORITY_OR_OTHER||Treatment ratio|1.04|||<|0.0001|TWO_SIDED|95.0|1.02|1.06|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.06|1.02|<0.0001
73956570|NCT01720446|147449108|SUPERIORITY_OR_OTHER||Treatment ratio|0.96||||0.0185|TWO_SIDED|95.0|0.93|0.99|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.99|0.93|0.0185
73956571|NCT01720446|147449108|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.5996|TWO_SIDED|95.0|0.96|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.03|0.96|0.5996
73956572|NCT01720446|147449108|SUPERIORITY_OR_OTHER||Treatment ratio|0.97||||0.1833|TWO_SIDED|95.0|0.93|1.01|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.01|0.93|0.1833
73989056|NCT05694533|147524036|OTHER|Descriptive only.|Geometric Mean Ratio|0.84|||||TWO_SIDED|90.0|0.76|0.92||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.92|0.76|
73989057|NCT05694533|147524036|OTHER|Descriptive only.|Geometric Mean Ratio|0.8|||||TWO_SIDED|90.0|0.69|0.93||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.93|0.69|
73989058|NCT05694533|147524037|OTHER|Descriptive only.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.78|0.92||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.92|0.78|
73989059|NCT05694533|147524037|OTHER|Descriptive only.|Geometric Mean Ratio|0.81|||||TWO_SIDED|90.0|0.74|0.89||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.89|0.74|
73989060|NCT05694533|147524038|OTHER|Descriptive only.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.78|0.91||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.91|0.78|
73989061|NCT05694533|147524038|OTHER|Descriptive only.|Geometric Mean Ratio|0.87|||||TWO_SIDED|90.0|0.78|0.97||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.97|0.78|
73875748|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|89.39|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 3.||100.00|89.39|
73875749|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.84|||||TWO_SIDED|95.0|79.81|95.51|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 3.||95.51|79.81|
73875750|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.74|||||TWO_SIDED|95.0|68.99|93.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 3.||93.35|68.99|
73989062|NCT01101997|147524041|SUPERIORITY||sucess proportion|0.853|||<|0.001|TWO_SIDED|95.0|0.773|0.91|||Chi-squared|||H0: p= 0.6 and Ha: p ≠ 0.6||.910|.773|<0.001
74035025|NCT00755846|147622417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|1.06||0.418||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.418
74035026|NCT00755846|147622418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.95||0.617||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.617
73989063|NCT01101997|147524042|OTHER||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|2.49|||TWO_SIDED|||||||||||||
73989064|NCT01983553|147524044|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.93|||||TWO_SIDED|95.0|0.64|1.36|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Any of the 4 Serotypes||1.36|0.64|
73989065|NCT01983553|147524044|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.96|||||TWO_SIDED|95.0|0.44|2.21|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 1||2.21|0.44|
73989066|NCT01983553|147524044|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.326|||||TWO_SIDED|95.0|0.64|2.94|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 2||2.94|0.64|
73989067|NCT01983553|147524044|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.056|||||TWO_SIDED|95.0|0.48|2.51|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 3||2.51|0.48|
73989068|NCT01983553|147524044|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.629|||||TWO_SIDED|95.0|0.27|1.47|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 4||1.47|0.27|
73875751|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.75|||||TWO_SIDED|95.0|80.31|95.24|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 4.||95.24|80.31|
73956573|NCT01720446|147449108|SUPERIORITY_OR_OTHER||Treatment ratio|0.93||||0.0009|TWO_SIDED|95.0|0.89|0.97|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.97|0.89|0.0009
73956574|NCT01720446|147449109|SUPERIORITY_OR_OTHER||Treatment ratio|0.78||||0.0003|TWO_SIDED|95.0|0.68|0.89|||Mixed Models Analysis||Sema 0.5 mg / Placebo 0.5 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||0.89|0.68|0.0003
73956575|NCT01720446|147449109|SUPERIORITY_OR_OTHER||Treatment ratio|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.81|||Mixed Models Analysis||Sema 1.0 mg / Placebo 1.0 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.81|0.62|<0.0001
73956576|NCT01720446|147449110|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.9205|TWO_SIDED|95.0|-0.83|0.92|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.92|-0.83|0.9205
73956577|NCT01720446|147449110|SUPERIORITY_OR_OTHER||Treatment difference|0.14||||0.7477|TWO_SIDED|95.0|-0.74|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.03|-0.74|0.7477
73956578|NCT01720446|147449110|SUPERIORITY_OR_OTHER||Treatment difference|-1.27||||0.0976|TWO_SIDED|95.0|-2.77|0.23|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.23|-2.77|0.0976
73956579|NCT01720446|147449110|SUPERIORITY_OR_OTHER||Treatment difference|-2.59||||0.0008|TWO_SIDED|95.0|-4.09|-1.08|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-1.08|-4.09|0.0008
73956580|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|0.5||||0.3171|TWO_SIDED|95.0|-0.48|1.47|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.47|-0.48|0.3171
73956581|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|1.47||||0.0031|TWO_SIDED|95.0|0.5|2.45|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.45|0.50|0.0031
73956582|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|0.87||||0.035|TWO_SIDED|95.0|0.06|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.69|0.06|0.0350
73956583|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|1.42||||0.0007|TWO_SIDED|95.0|0.6|2.24|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.24|0.60|0.0007
73956584|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.7277|TWO_SIDED|95.0|-0.79|1.13|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.13|-0.79|0.7277
73956585|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|0.97||||0.0489|TWO_SIDED|95.0|0.0|1.94|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.94|0.00|0.0489
73956586|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment Difference|0.61||||0.186|TWO_SIDED|95.0|-0.3|1.53|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.53|-0.30|0.1860
73956587|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|1.39||||0.0029|TWO_SIDED|95.0|0.48|2.31|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.31|0.48|0.0029
73956588|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|0.68||||0.0833|TWO_SIDED|95.0|-0.09|1.45|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.45|-0.09|0.0833
74035027|NCT00755846|147622418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.2||0.052||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.052
74035028|NCT00755846|147622418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.28||0.906||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.906
74035029|NCT00755846|147622418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.19||0.628||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.628
74035030|NCT00755846|147622418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.22||0.749||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.749
74035031|NCT00755846|147622418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.22||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.340
74035032|NCT00755846|147622419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.31||0.269||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.269
73875752|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|93.88|||||TWO_SIDED|95.0|60.62|99.85|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 4.||99.85|60.62|
74039646|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1032|TWO_SIDED|95.0|0.96|1.59|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.96|0.1032
74039647|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.12||||0.4418|TWO_SIDED|95.0|0.84|1.5|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.50|0.84|0.4418
74039648|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1608|TWO_SIDED|95.0|0.92|1.63|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.63|0.92|0.1608
74039649|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.29||||0.2628|TWO_SIDED|95.0|0.83|2.02|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.02|0.83|0.2628
74039650|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0447|TWO_SIDED|95.0|1.01|2.39|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.01|0.0447
74039651|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.16||||0.256|TWO_SIDED|95.0|0.9|1.49|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.90|0.2560
74039652|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1741|TWO_SIDED|95.0|0.93|1.53|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.93|0.1741
73989069|NCT01983553|147524044|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|1.22|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Unserotyped||1.22|0.00|
73989070|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.411|||||TWO_SIDED|95.0|0.64|3.42|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Any Serotype||3.42|0.64|
73989071|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.807|||||TWO_SIDED|95.0|0.53|1.25|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Any Serotype||1.25|0.53|
73989072|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|4.885|||||TWO_SIDED|95.0|0.7|212.02|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 1||212.02|0.70|
73989073|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.557|||||TWO_SIDED|95.0|0.21|1.46|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 1||1.46|0.21|
73989074|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|2.931|||||TWO_SIDED|95.0|0.36|134.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 2||134.83|0.36|
73989075|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.165|||||TWO_SIDED|95.0|0.53|2.74|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 2||2.74|0.53|
73989076|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants at Year 1 for Serotype 3 (4 to 5 year) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.221|||||TWO_SIDED|95.0|0.2|12.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 3||12.83|0.20|
73989077|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.013|||||TWO_SIDED|95.0|0.41|2.73|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 3||2.73|0.41|
73989078|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.977|||||TWO_SIDED|95.0|0.21|6.04|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 4||6.04|0.21|
73989079|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.506|||||TWO_SIDED|95.0|0.18|1.44|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 4||1.44|0.18|
73989080|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.6|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Unserotyped||2.60|0.00|
74039653|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1647|TWO_SIDED|95.0|0.93|1.55|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.93|0.1647
73989081|NCT01983553|147524047|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|19.75|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Unserotyped||19.75|0.00|
73989082|NCT01983553|147524055|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.174|||||TWO_SIDED|95.0|0.27|7.03|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Any grade||7.03|0.27|
73989083|NCT01983553|147524055|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||TWO_SIDED|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade I||4.83|0.00|
73875753|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.62|||||TWO_SIDED|95.0|66.1|99.04|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 4.||99.04|66.10|
73956589|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|1.4||||0.0004|TWO_SIDED|95.0|0.62|2.17|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.17|0.62|0.0004
73956590|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|0.8||||0.0799|TWO_SIDED|95.0|-0.1|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.69|-0.10|0.0799
73956591|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|1.5||||0.0011|TWO_SIDED|95.0|0.6|2.4|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.40|0.60|0.0011
74035033|NCT00755846|147622419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|STANDARD_ERROR_OF_MEAN|5.46||0.076||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.076
74039654|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0619|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.65|0.99|0.0619
73956592|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|0.53||||0.3717|TWO_SIDED|95.0|-0.63|1.68|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.68|-0.63|0.3717
73956593|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|0.94||||0.1136|TWO_SIDED|95.0|-0.22|2.1|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.10|-0.22|0.1136
73956594|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|0.72||||0.1431|TWO_SIDED|95.0|-0.24|1.67|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.67|-0.24|0.1431
73956595|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|1.14||||0.0197|TWO_SIDED|95.0|0.18|2.11|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.11|0.18|0.0197
73956596|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|-0.05||||0.9223|TWO_SIDED|95.0|-1.03|0.93|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.93|-1.03|0.9223
73956597|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|1.14||||0.0237|TWO_SIDED|95.0|0.15|2.13|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.13|0.15|0.0237
73956598|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|0.33||||0.4523|TWO_SIDED|95.0|-0.53|1.19|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.19|-0.53|0.4523
73956599|NCT01720446|147449114|SUPERIORITY_OR_OTHER||Treatment difference|1.2||||0.0064|TWO_SIDED|95.0|0.34|2.07|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.07|0.34|0.0064
73956600|NCT01720446|147449115|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.7796|TWO_SIDED|95.0|0.95|1.04|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.04|0.95|0.7796
73956601|NCT01720446|147449115|SUPERIORITY_OR_OTHER||Treatment ratio|0.92||||0.0003|TWO_SIDED|95.0|0.88|0.96|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.96|0.88|0.0003
73956602|NCT01720446|147449116|SUPERIORITY_OR_OTHER||Treatment difference|2.02|||<|0.0001|TWO_SIDED|95.0|1.07|2.98|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.98|1.07|<0.0001
73875754|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.96|||||TWO_SIDED|95.0|77.96|95.13|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 4.||95.13|77.96|
73875755|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.86|||||TWO_SIDED|95.0|73.3|95.33|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 4.||95.33|73.30|
73875756|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|83.87|||||TWO_SIDED|95.0|68.31|92.63|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 6.||92.63|68.31|
73875757|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.5|||||TWO_SIDED|95.0|46.83|98.61|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 6.||98.61|46.83|
73989084|NCT01983553|147524055|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|2.012|||||TWO_SIDED|95.0|0.2|99.1|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade II||99.10|0.20|
73989085|NCT01983553|147524055|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Any grade||39.49|0.01|
73989086|NCT01983553|147524055|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Grade I||39.49|0.01|
73989087|NCT01983553|147524055|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||TWO_SIDED|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Any grade||4.83|0.00|
73989088|NCT01983553|147524055|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|19.62|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade I||19.62|0.00|
73989089|NCT01983553|147524055|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade II||39.49|0.01|
73989090|NCT00496626|147524058|SUPERIORITY_OR_OTHER||GMT ratio|101.6|||<=|0.05|TWO_SIDED|95.0|88.1|117.2||The ANCOVA models showed the lower bounds of two-sided 95% CI on the GMT ratio \[GARDASIL™/placebo\] were greater than 1 for each HPV type, so the null hypothesis was rejected. The CI reported is for HPV18, the type with the smallest CI lower bound.|ANCOVA||Superiority of GARDASIL™ to placebo was claimed if, for each of the four HPV types, the lower bound of the two-sided 95% CI on the GMT ratio \[GARDASIL™/placebo\] being \>1, or equivalently, the two-sided p-value \<0.05.|An Analysis of Covariance (ANCOVA) model was used for each HPV type, based on the pooled data from all age groups and genders. The natural-log-transformed titer was the response variable, and vaccination group, gender and age group were covariates. The null hypothesis was that the GMT ratio (Gardasil/Placebo) was equal to 1.||117.2|88.1|<=0.05
74035034|NCT00755846|147622419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|5.66||0.867||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.867
73989091|NCT00496626|147524059|SUPERIORITY_OR_OTHER||Seroconversion Rate|96.65|||<=|0.05||95.0|93.74|98.46||The lower bound of the 95% CI for the seroconversion rate was greater than 90% for each type so the null hypothesis was rejected. The CI reported is for HPV6, the type with the smallest lower bound.|Exact Binomial CI|||The null hypothesis was that the seroconversion rate in the Gardasil® Group was less than 90% for each HPV type.||98.46|93.74|<=0.05
73875758|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.31|||||TWO_SIDED|95.0|48.79|99.82|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 6.||99.82|48.79|
73875759|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.98|||||TWO_SIDED|95.0|63.64|93.05|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 6.||93.05|63.64|
74035035|NCT00755846|147622419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|5.4||0.169||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.169
74035036|NCT00755846|147622419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|5.45||0.645||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.645
74039655|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2025|TWO_SIDED|95.0|0.9|1.61|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.61|0.90|0.2025
73956603|NCT01720446|147449116|SUPERIORITY_OR_OTHER||Treatment difference|2.47|||<|0.0001|TWO_SIDED|95.0|1.52|3.43|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||3.43|1.52|<0.0001
73956604|NCT02175212|147449132|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.88||||0.01|TWO_SIDED|95.0|1.12|3.15|||Regression, Cox|||||3.15|1.12|0.01
74039656|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2601|TWO_SIDED|95.0|0.88|1.58|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.88|0.2601
73956605|NCT02175212|147449133|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.31||||0.01|TWO_SIDED|95.0|1.23|3.85|||Regression, Cox|||||3.85|1.23|0.01
73956606|NCT02175212|147449134|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.48||||0.009|TWO_SIDED|95.0|1.31|4.68|||Regression, Cox|||||4.68|1.31|0.009
73956607|NCT00315120|147449139|SUPERIORITY_OR_OTHER||Response ratio|2.0||||0.007|TWO_SIDED|95.0|1.2|3.2|||Chi-squared|||||3.2|1.2|0.007
73956608|NCT00315120|147449144|SUPERIORITY_OR_OTHER||Response ratio|1.1||||0.72|TWO_SIDED|95.0|0.7|1.7|||Chi-squared|||||1.7|0.7|0.72
73956609|NCT02131324|147449165|EQUIVALENCE|Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.||||||0.086|||||||ANOVA|||Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.||||0.086
73956610|NCT00420316|147449176|SUPERIORITY_OR_OTHER||Percent reduction|34.3||||0.691|TWO_SIDED|95.0|-348.7|88.9|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strain. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||88.9|-348.7|0.691
73956611|NCT00420316|147449177|SUPERIORITY_OR_OTHER||Percent reduction|50.7||||0.551|TWO_SIDED|95.0|-3769.6|99.4|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who have received placebo.||99.4|-3769.6|0.551
73956612|NCT00420316|147449179|SUPERIORITY_OR_OTHER||Percent reduction|100.0||||0.33|TWO_SIDED|95.0|-1822.5|100.0|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of serotype G1. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||100|-1822.5|0.33
73956613|NCT00420316|147449180|SUPERIORITY_OR_OTHER||Percent reduction|-97.2||||1|TWO_SIDED|95.0|-9610.8|80.5|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||80.5|-9610.8|1
73956614|NCT00420316|147449181|SUPERIORITY_OR_OTHER||Percent reduction|0.0||||1|TWO_SIDED|95.0|0.0|98.7|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||98.7|0|1
73875760|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.0|||||TWO_SIDED|95.0|54.3|92.5|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 6.||92.50|54.30|
73875761|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|83.61|||||TWO_SIDED|95.0|67.76|92.51|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 7.||92.51|67.76|
73989092|NCT02005393|147524067|NON_INFERIORITY_OR_EQUIVALENCE|Image settings were considered non-inferior if scores overlapped within 1 SD of mean.||||||||||||||||All 20 subjects enrolled in the study, including Subject 219 that was dropped from the Reader assessments due to corrupted images, were all rated as having similar white light images between the FICE and NBI procedures for each location used in the concurrence study. This assessment was intended to assure that no procedural sequence or visualization bias was introduced into the image acquisition process. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).|The results reported utilized the average Likert scores for each of the 3 readers, for each of the FICE settings (0-9), as compared to FICE. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).The overall mean scores were comparable between FICE and NBI to provide acceptable diagnostic image visualization quality.|||
74035037|NCT00755846|147622419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.51||0.351||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.351
73989093|NCT00726713|147524127|SUPERIORITY_OR_OTHER||||||=|0.013|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16||||=0.013
73989094|NCT00726713|147524127|SUPERIORITY_OR_OTHER||||||=|0.033|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 24||||=0.033
73989095|NCT00726713|147524128|SUPERIORITY_OR_OTHER||||||=|0.027|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16||||=0.027
73989096|NCT00726713|147524129|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 16||||=0.0001
73989097|NCT00726713|147524129|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 24||||=0.0001
73989098|NCT00726713|147524129|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from Baseline Week 16||||=0.0001
73989099|NCT00726713|147524129|SUPERIORITY_OR_OTHER||||||=|0.0008|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from BL, Week 24||||=0.0008
73989100|NCT00726713|147524129|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Homocysteine, Change from BL, Week 16||||=0.0001
74039657|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.14||||0.5635|TWO_SIDED|95.0|0.73|1.77|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.77|0.73|0.5635
73989101|NCT00726713|147524129|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total Homocysteine, Change from BL, Week 24||||=0.0001
73989102|NCT00726713|147524130|SUPERIORITY_OR_OTHER||||||=|0.0306||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||SF-36 MCS, Change from BL, Week 24||||=0.0306
73989103|NCT00726713|147524133|SUPERIORITY_OR_OTHER||||||=|0.054|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||HADS Depression, Change from BL, Week 24||||=0.054
73989104|NCT03247738|147524150|SUPERIORITY|The primary end point of our study was the comparison of platelet reactivity measured by VerifyNow PRU between cangrelor and placebo at 30 minutes after drugs were administered at the start of PCI. Assuming a common standard deviation of 70 PRU, a sample size of 20 patients per group would allow detection of a 70 PRU difference between groups with 85% power and a two-sided α = 0.05. Considering the 2 arms and a possible 25% rate of invalid PD results we planned to randomize up to 50 patients.|Mean Difference (Net)|152.0|||<|0.001|TWO_SIDED|95.0|108.0|195.0|||ANCOVA|the baseline value of platelet reactivity used as a covariate||||195|108|<0.001
73989105|NCT00129649|147524152|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
73989106|NCT00511797|147524159|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.49|-0.34||Pre-defined sequential tests were applied to protect alpha inflation by multiplicity.|t-test, 1 sided|||Three null hypotheses were sequentially tested. H01: DRSP 3 mg \>= Placebo (Active is equal or less in decrease of score) vs H11: DRSP 3 mg \< Placebo (Active is greater in decrease of score), H02: DRSP 2 mg \>= Placebo vs H12: DRSP 2 mg \< Placebo, H03: DRSP 1 mg \>= Placebo vs H13: DRSP 1 mg \< Placebo.||-0.34|-1.49|<0.001
73956615|NCT00420316|147449182|SUPERIORITY_OR_OTHER||Percent reduction|-23.2||||0.817|TWO_SIDED|95.0|-287.7|54.8|||Fisher Exact|||Vaccine efficacy with respect to severe gastroenteritis (GE) was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||54.8|-287.7|0.817
74035038|NCT00755846|147622420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|STANDARD_ERROR_OF_MEAN|4.03||0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.003
74035039|NCT00755846|147622420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6|STANDARD_ERROR_OF_MEAN|5.06|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
74035040|NCT00755846|147622420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|5.26||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.103
74035041|NCT00755846|147622420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0|STANDARD_ERROR_OF_MEAN|4.98||0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.009
74039658|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1338|TWO_SIDED|95.0|0.91|2.11|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.11|0.91|0.1338
73956616|NCT02145182|147449185|SUPERIORITY||Odds Ratio (OR)|0.81||||0.3983|TWO_SIDED|95.0|0.49|1.33|||Regression, Logistic|Logistic regression results for the DGF composite, the effect of treatment adjusted for preservation type, donor type, and Irish score.|Calculated using the logistic regression model.|Analysis of DGF composite||1.33|0.49|0.3983
73956617|NCT05419557|147449190|SUPERIORITY||Odds Ratio (OR)|8.5||||0.02|TWO_SIDED|95.0|1.3|54.6|||Regression, Logistic|||||54.6|1.3|0.02
73956618|NCT05419557|147449191|SUPERIORITY||Odds Ratio (OR)|9.98||||0.015|TWO_SIDED|95.0|1.55|64.25|||Regression, Logistic|||||64.25|1.55|0.015
73956619|NCT00558363|147449228|SUPERIORITY_OR_OTHER||Relative Risk (Hazard Ratio)|0.34|||<|0.001|TWO_SIDED|95.0|0.23|0.5||Comparing 24-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox Proportional Hazard model stratified by site cluster and previous therapy|||0.50|0.23|<0.001
73956620|NCT00558363|147449238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparing percentages of participants with PSA doubling: 57% versus 28%|Mantel-Haenszel Chi-Square|||||||<0.001
73956621|NCT00558363|147449239|SUPERIORITY_OR_OTHER||Relative Risk (Hazard Ratio)|0.25|||<|0.001||95.0|0.14|0.45||Comparing 12-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox proportional hazard model stratified by site cluster and previous therapy|||0.45|0.14|<0.001
73956622|NCT00558363|147449240|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparing percentages of participants with PSA doubling: 35% versus 10%|Mantel-Haenszel Chi-Square|||||||<0.001
73956623|NCT00606580|147449257|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.||||0.0001
73956624|NCT00606580|147449257|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.||||<0.0001
73956625|NCT00606580|147449257|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.871|||||||Chi-squared|||H02: There is no difference in clinical cure between WR 279,396 and Paromomycin Alone. Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||0.871
73956626|NCT00606580|147449258|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Chi-squared|||||||0.0006
73956627|NCT00606580|147449258|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Chi-squared|||||||0.0002
73956628|NCT00606580|147449258|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.767|||||||Chi-squared|||||||0.767
74089884|NCT02312713|147732639|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.97|TWO_SIDED|95.0|-0.97|0.93|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Unilateral Stand Time.||0.93|-0.97|0.97
74089885|NCT02312713|147732639|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.93|TWO_SIDED|95.0|-0.91|1.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Unilateral Stand Time||1|-0.91|0.93
74089886|NCT02312713|147732639|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.61||||0.12|TWO_SIDED|95.0|-0.16|1.38|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Unilateral Stand Time.||1.38|-0.16|0.12
74089887|NCT02312713|147732639|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.78|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Unilateral Stand Time.||0.77|-0.78|1.00
74089888|NCT02312713|147732640|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.63|TWO_SIDED|95.0|-1.55|0.94|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for 30 Second Chair Stand.||.94|-1.55|0.63
73956629|NCT00606580|147449259|SUPERIORITY_OR_OTHER|||||||0.33|||||||Log Rank|Mantel-Cox (log-rank) grouped failure time test using proportion re-epithelialized at each of the scheduled assessments through Day 42 without relapse||||||0.330
73956630|NCT00606580|147449259|SUPERIORITY_OR_OTHER|||||||0.275|||||||Log Rank|||||||0.275
73956631|NCT00606580|147449259|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.83|||||||Log Rank|||||||0.830
73956632|NCT00606580|147449264|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
73956633|NCT00606580|147449264|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73956634|NCT00606580|147449264|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.725|||||||Chi-squared|||||||0.725
73956635|NCT00606580|147449265|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
73956636|NCT00606580|147449265|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
73956637|NCT00606580|147449265|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||1|||||||Chi-squared|||||||1.000
73956638|NCT00606580|147449266|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||||||0.003
73956639|NCT00606580|147449266|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
73956640|NCT00606580|147449266|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.893|||||||Chi-squared|||||||0.893
73956641|NCT00606580|147449267|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73956642|NCT00606580|147449267|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73956643|NCT00606580|147449267|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.247|||||||Chi-squared|||||||0.247
73956644|NCT00606580|147449268|SUPERIORITY_OR_OTHER|||||||0.409|||||||Chi-squared|||||||0.409
73956645|NCT00606580|147449268|SUPERIORITY_OR_OTHER|||||||0.651|||||||Chi-squared|||||||0.651
73956646|NCT00606580|147449268|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.701|||||||Chi-squared|||||||0.701
73956647|NCT03736785|147449304|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
73956648|NCT03736785|147449304|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
73956649|NCT03736785|147449304|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
73956650|NCT03736785|147449305|NON_INFERIORITY|Non-inferiority margin is 0.4%|LSMean Difference|0.08|||||TWO_SIDED|90.0|-0.11|0.28|||Mixed Models Analysis|||||0.28|-0.11|
73956651|NCT03736785|147449305|NON_INFERIORITY|Non-inferiority margin is 0.4%|LSMean Difference|0.09|||||TWO_SIDED|90.0|-0.1|0.29|||Mixed Models Analysis|||||0.29|-0.10|
73956652|NCT00843193|147449353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1955|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2||0.06|-0.27|0.1955
73956653|NCT00843193|147449353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0193|TWO_SIDED|95.0|-0.34|-0.03|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4||-0.03|-0.34|0.0193
73956654|NCT00843193|147449353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.6156|TWO_SIDED|95.0|-0.23|0.14|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8||0.14|-0.23|0.6156
73956655|NCT00843193|147449353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.4672|TWO_SIDED|95.0|-0.31|0.14|||ANCOVA|||Comparison between GSK679586 120 mg/kg and Placebo at Week 12||0.14|-0.31|0.4672
73956656|NCT00843193|147449356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7693|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2||0.06|-0.08|0.7693
73956657|NCT00843193|147449356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.8987|TWO_SIDED|95.0|-0.08|0.09|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4||0.09|-0.08|0.8987
73956658|NCT00843193|147449356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.4231|TWO_SIDED|95.0|-0.12|0.05|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8||0.05|-0.12|0.4231
74089889|NCT02312713|147732640|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.37|TWO_SIDED|95.0|-1.58|0.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for 30 Second Chair Stand.||0.6|-1.58|0.37
74089890|NCT02312713|147732640|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.62|TWO_SIDED|95.0|-0.95|1.59|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for 30 Second Chair Stand.||1.59|-0.95|0.62
73989107|NCT00511797|147524159|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.277|<|0.001||95.0|-1.64|-0.55|||t-test, 1 sided|||Second null hypothesis was tested. H02: DRSP 2 mg \>= Placebo vs H12: DRSP 2 mg \< Placebo.||-0.55|-1.64|<0.001
73989108|NCT00511797|147524159|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.28|<|0.001||95.0|-2.0|-0.89|||t-test, 1 sided|||Third null hypotheses was tested. H03: DRSP 1 mg \>= Placebo vs H13: DRSP 1 mg \< Placebo.||-0.89|-2.00|<0.001
73989109|NCT00511797|147524160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-1.74|-0.46|||t-test, 1 sided|||Test results of 3 mg DRSP and placebo at Cycle 4 are shown. 2-sided 95% confidence intervals were calculated. To keep consistency with 2-sided 95% confidence intervals, 2.5% 1-sided significance levels were used for the statistical tests.||-0.46|-1.74|<0.001
73989110|NCT00511797|147524160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.306|<|0.001||95.0|-1.95|-0.73|||t-test, 1 sided|||||-0.73|-1.95|<0.001
73989111|NCT00511797|147524160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|0.317|<|0.001||95.0|-2.16|-0.9|||t-test, 1 sided|||||-0.90|-2.16|<0.001
73989112|NCT03974100|147524183|EQUIVALENCE|Equivalence criteria (analysis set PPS): 95% CI for difference in means contained in \[-1.45%, 1.45%\]|Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.3325|||TWO_SIDED|95.0|-0.798|0.509|||Mixed-model repeated measures (MMRM)|MMRM included treatment, prior bisphosphonate use, DXA machine type, visit, visit-treatment interaction, and baseline LS-BMD as a continuous covariate|Difference GP2411 (Test) - EU-Prolia (Reference)|||0.509|-0.798|
73989113|NCT03974100|147524184|EQUIVALENCE|Equivalence criteria (analysis set TP1 FAS): 95% CI for difference in means contained in \[-1.45%, 1.45%\] (criteria 1) or in \[-2.00%, 2.00%\] (criteria 2)|Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.3321|||TWO_SIDED|95.0|-0.83|0.475|||Mixed-model repeated measures (MMRM)|MMRM included treatment, prior bisphosphonate use, DXA machine type, visit, visit-treatment interaction, and baseline LS-BMD as a continuous covariate|Difference GP2411 (Test) - EU-Prolia (Reference)|||0.475|-0.830|
73989114|NCT03974100|147524185|EQUIVALENCE|Equivalence criteria (analysis set PDS): 95% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||ANCOVA|ANCOVA was performed on log-transformed AUEC including treatment and log baseline CTX value as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.01|0.98|
73989115|NCT03974100|147524185|EQUIVALENCE|Equivalence criteria (analysis set PDS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.98|1.01|||ANCOVA|ANCOVA was performed on log-transformed AUEC including treatment and log baseline CTX value as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.01|0.98|
73989116|NCT03974100|147524186|EQUIVALENCE|Equivalence criteria (analysis set PKS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.92|1.03|||ANCOVA|ANCOVA was performed on log-transformed Cmax including treatment and weight as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.03|0.92|
73989117|NCT03974100|147524187|EQUIVALENCE|Equivalence criteria (analysis set PKS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05|||ANCOVA|ANCOVA was performed on log-transformed AUCinf including treatment and weight as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.05|0.93|
74089891|NCT02312713|147732640|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.67|TWO_SIDED|95.0|-0.87|1.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for 30 Second Chair Stand.||1.35|-0.87|0.67
73989118|NCT02024750|147524221|OTHER||Mean Difference (Net)|0.005||||0.72|TWO_SIDED|95.0|-0.021|0.03||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.||0.030|-0.021|0.72
73989119|NCT02024750|147524221|OTHER||Mean Difference (Net)|-0.01||||0.38|TWO_SIDED|95.0|-0.034|0.013||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the post-intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.||0.013|-0.034|0.38
73989120|NCT02024750|147524222|OTHER||Mean Difference (Net)|0.023||||0.87|TWO_SIDED|95.0|-0.249|0.295||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.295|-0.249|0.87
73989121|NCT02024750|147524222|OTHER||Mean Difference (Net)|-0.074||||0.74|TWO_SIDED|95.0|-0.517|0.369||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.369|-0.517|0.74
73989122|NCT02024750|147524223|OTHER||Mean Difference (Net)|-0.037||||0.79|TWO_SIDED|95.0|-0.312|0.237||The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.237|-0.312|0.79
73989123|NCT02024750|147524223|OTHER||Mean Difference (Net)|-0.009||||0.97|TWO_SIDED|95.0|-0.467|0.448||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.448|-0.467|0.97
74089892|NCT02312713|147732640|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.63||||0.23|TWO_SIDED|95.0|-0.4|1.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for 30 Second Chair Stand.||1.66|-0.40|0.23
74089893|NCT02312713|147732640|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.74||||0.11|TWO_SIDED|95.0|-0.17|1.64|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for 30 Second Chair Stand.||1.64|-0.17|0.11
74089894|NCT02312713|147732641|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.52|TWO_SIDED|95.0|-1.58|0.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Timed Up and Go.||0.8|-1.58|0.52
73989124|NCT02024750|147524224|OTHER||Mean Difference (Net)|0.134||||0.3|TWO_SIDED|95.0|-0.121|0.388||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.||0.388|-0.121|0.30
73989125|NCT02024750|147524224|OTHER||Mean Difference (Net)|-0.006||||0.98|TWO_SIDED|95.0|-0.384|0.373||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.||0.373|-0.384|0.98
73989126|NCT00702546|147524225|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-9.4|||||TWO_SIDED|95.0|-19.5|0.7||||||Treatment groups were compared with a generalized linear model for the cumulative ongoing pregnancy rate including covariates treatment group, age class (\< 32 yrs vs. ≥ 32 yrs), planned IVF treatment (IVF vs. ICSI) and region (Europe vs. Asia).||0.7|-19.5|
73989127|NCT00953199|147524235|SUPERIORITY_OR_OTHER|||||||0.45||||||.05 was set as level of significance|Chi-squared|||We calculated the sample size to be 570 in each arm, providing 80% power, allocation 1:1, two-sided, alpha 0.05, withdrawal rate of 3% and a reduction in pancreatitis from 8% to 4%. Randomization is performed with permuted blocks of 20. Analysis is based on intention to treat.||||.45
73989128|NCT00691678|147524250|SUPERIORITY||Mean Difference (Final Values)|-13.3||||0.004|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis measures whether there is a statistically significant change, at the 5% significance level, between the mean WOMAC score among study participants at baseline and at week 24.||||0.004
73989129|NCT03151551|147524260|SUPERIORITY||Rate Difference|8.1||||0.036|TWO_SIDED|95.0|0.5|15.8|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 24.||15.8|0.5|0.036
73989130|NCT03151551|147524261|NON_INFERIORITY|If the lower bound of the 2-sided 95% confidence Interval (CI) for the difference in proportions of responders on IXE minus ADA is greater than the pre-specified margin -12%, IXE will be deemed non-inferior to ADA.|Rate Difference|3.9|||||TWO_SIDED|95.0|-4.3|12.1||||||||12.1|-4.3|
74035042|NCT00755846|147622420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.14||0.034||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.034
74089895|NCT02312713|147732641|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.46|TWO_SIDED|95.0|-1.86|0.85|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Timed Up and Go.||0.85|-1.86|0.46
74089896|NCT02312713|147732641|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.3|TWO_SIDED|95.0|-1.85|0.58|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Timed Up and Go.||0.58|-1.85|0.3
73989131|NCT03151551|147524262|SUPERIORITY||Rate Difference|13.4||||0.001|TWO_SIDED|95.0|5.3|21.6|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 24.||21.6|5.3|0.001
73989132|NCT03151551|147524263|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.725||0.155|TWO_SIDED|95.0|-2.46|0.39|||Mixed Models Analysis|||||0.39|-2.46|0.155
73989133|NCT03151551|147524264|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.249||0.823|TWO_SIDED|95.0|-0.54|0.43|||Mixed Models Analysis|||||0.43|-0.54|0.823
73875762|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|93.33|||||TWO_SIDED|95.0|56.67|99.84|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 7.||99.84|56.67|
73989134|NCT03151551|147524265|SUPERIORITY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|2.104||0.752|TWO_SIDED|95.0|-4.8|3.47|||Mixed Models Analysis|||||3.47|-4.80|0.752
73989135|NCT03151551|147524266|SUPERIORITY||Mean Difference (Final Values)|-2.79|STANDARD_ERROR_OF_MEAN|2.06||0.177|TWO_SIDED|95.0|-6.83|1.26|||Mixed Models Analysis|||||1.26|-6.83|0.177
73989136|NCT03151551|147524267|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|1.391||0.332|TWO_SIDED|95.0|-4.08|1.38|||Mixed Models Analysis|||||1.38|-4.08|0.332
74089897|NCT02312713|147732641|SUPERIORITY||Mean Difference (Final Values)|-1.22||||0.08|TWO_SIDED|95.0|-2.61|0.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Timed Up and Go.||0.16|-2.61|0.08
73956659|NCT00843193|147449356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.0537|TWO_SIDED|95.0|-0.19|0.0|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 12||0.00|-0.19|0.0537
73956660|NCT04511650|147449375|SUPERIORITY|||||||0.4795|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by disease severity.||Pooled Razuprotafib comparison to Placebo. All results are summarized descriptively by treatment arm and expressed as proportions, along with corresponding 95% confidence intervals (CIs) of the difference between response rates, and p-values.||||0.4795
73956661|NCT00964119|147449392|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|90.0||||P-value \< .05 is the computed p-value for this measurement.|t-test, 2 sided|||PI and lead author left the institution before publishing data. Study has been closed and data files archived.||||<.05
73956662|NCT01081145|147449393|SUPERIORITY_OR_OTHER_LEGACY||Difference in treatment failures|-15.6||||0.006|TWO_SIDED|95.0|-26.6|-4.5|||Cochran-Mantel-Haenszel|||||-4.5|-26.6|0.006
73956663|NCT01081145|147449394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Log Rank|||||||0.003
73956664|NCT01081145|147449395|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-6.24|||<|0.001|TWO_SIDED|95.0|-9.01|-3.48||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-3.48|-9.01|<0.001
73956665|NCT01081145|147449396|SUPERIORITY_OR_OTHER_LEGACY||Difference in percent of subjects|17.5||||0.001|TWO_SIDED|95.0|6.6|28.5||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||28.5|6.6|0.001
73956666|NCT01081145|147449397|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.06||||0.118|TWO_SIDED|95.0|-0.14|0.02||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.02|-0.14|0.118
73956667|NCT01081145|147449400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided|||||||<0.001
73956668|NCT01081145|147449404|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided|||||||<0.001
73956669|NCT00816829|147449410|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.048
73956670|NCT00816829|147449411|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.203
73956671|NCT00816829|147449412|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between groups was performed using Wilcoxon Test on data at one month after the start of the treatment.||||0.007
73956672|NCT00816829|147449413|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.199
73956673|NCT00816829|147449414|SUPERIORITY_OR_OTHER|||||||0.114||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.114
73956674|NCT00816829|147449415|SUPERIORITY_OR_OTHER|||||||0.533||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.533
73956675|NCT00816829|147449416|SUPERIORITY_OR_OTHER|||||||0.521||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.521
73956676|NCT00816829|147449417|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.333
73956677|NCT00816829|147449418|SUPERIORITY_OR_OTHER|||||||0.264||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.264
73956678|NCT00816829|147449419|SUPERIORITY_OR_OTHER|||||||0.401||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.401
73956679|NCT01018511|147449430|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Overall power was 90% power for non-inferiority vs placebo for total IPSS. Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|97.5|-1.73|0.11||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The non-inferiority of FDC vs TOCAS on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.11|-1.73|0.001
73989137|NCT03151551|147524268|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.599||0.592|TWO_SIDED|95.0|-0.86|1.5|||Mixed Models Analysis|||||1.50|-0.86|0.592
73989138|NCT03151551|147524269|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.176|TWO_SIDED|95.0|-0.15|0.03|||Mixed Models Analysis|||||0.03|-0.15|0.176
73989139|NCT03151551|147524270|SUPERIORITY||Rate Difference|13.1|||<|0.001|TWO_SIDED|95.0|5.4|20.7|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 52.||20.7|5.4|<0.001
73989140|NCT03151551|147524271|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.091||0.368|TWO_SIDED|95.0|-0.26|0.1|||Mixed Models Analysis|||||0.10|-0.26|0.368
73989141|NCT03151551|147524272|SUPERIORITY||Rate Difference|6.4||||0.108|TWO_SIDED|95.0|-1.8|14.5|||Regression, Logistic|||MDA-18 Entheseal Points||14.5|-1.8|0.108
73989142|NCT03151551|147524272|SUPERIORITY||Rate Difference|5.3||||0.179|TWO_SIDED|95.0|-2.9|13.5|||Regression, Logistic|||MDA-6 Entheseal Points||13.5|-2.9|0.179
73989143|NCT03151551|147524273|SUPERIORITY||Rate Difference|-1.1||||0.846|TWO_SIDED|95.0|-8.9|6.7|||Regression, Logistic|||||6.7|-8.9|0.846
74089898|NCT02312713|147732641|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.24||||0.63|TWO_SIDED|95.0|-1.23|0.74|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Timed Up and Go.||0.74|-1.23|0.63
73989144|NCT03151551|147524274|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.83|-0.16|||Mixed Models Analysis|||||-0.16|-0.83|0.004
73989145|NCT03151551|147524275|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.305||0.687|TWO_SIDED|95.0|-0.48|0.72|||Mixed Models Analysis|||||0.72|-0.48|0.687
73989146|NCT03151551|147524276|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.144||0.507|TWO_SIDED|95.0|-0.19|0.38|||Mixed Models Analysis|||||0.38|-0.19|0.507
73989147|NCT03151551|147524277|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|14.951||0.82|TWO_SIDED|95.0|-32.78|25.99|||Mixed Models Analysis|||||25.99|-32.78|0.820
73989148|NCT03151551|147524278|SUPERIORITY||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.79||0.052|TWO_SIDED|95.0|-3.09|0.02|||Mixed Models Analysis|||||0.02|-3.09|0.052
73989149|NCT03151551|147524279|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.949||0.005|TWO_SIDED|95.0|-4.57|-0.84|||Mixed Models Analysis|||||-0.84|-4.57|0.005
73989150|NCT03151551|147524280|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.202||0.158|TWO_SIDED|95.0|-0.68|0.11|||Mixed Models Analysis|||||0.11|-0.68|0.158
73989151|NCT03151551|147524281|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.21||0.711|TWO_SIDED|95.0|-0.49|0.33|||Mixed Models Analysis|||||0.33|-0.49|0.711
73989152|NCT03151551|147524282|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.674||0.439|TWO_SIDED|95.0|-0.8|1.85|||Mixed Models Analysis|||||1.85|-0.80|0.439
73989153|NCT03151551|147524283|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.86||0.594|TWO_SIDED|95.0|-1.23|2.15|||Mixed Models Analysis|||||2.15|-1.23|0.594
73989154|NCT03151551|147524284|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.017||0.979|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|||||0.03|-0.03|0.979
73989155|NCT03151551|147524285|SUPERIORITY||Mean Difference (Final Values)|4.78|STANDARD_ERROR_OF_MEAN|1.782||0.008|TWO_SIDED|95.0|1.28|8.28|||Mixed Models Analysis|||||8.28|1.28|0.008
73989156|NCT03151551|147524286|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.335|<|0.001|TWO_SIDED|95.0|-1.78|-0.46|||Mixed Models Analysis|||||-0.46|-1.78|<0.001
73989157|NCT03151551|147524287|SUPERIORITY||Rate Difference|5.7||||0.165|TWO_SIDED|95.0|-2.4|13.7|||Regression, Logistic|||Effectiveness of Medication||13.7|-2.4|0.165
73989158|NCT03151551|147524287|SUPERIORITY||Rate Difference|6.7||||0.098|TWO_SIDED|95.0|-1.4|14.8|||Regression, Logistic|||Effectiveness over Time of Medication||14.8|-1.4|0.098
73989159|NCT03151551|147524287|SUPERIORITY||Rate Difference|4.6||||0.241|TWO_SIDED|95.0|-3.4|12.6|||Regression, Logistic|||Long Term Safety of Medication||12.6|-3.4|0.241
73989160|NCT03151551|147524287|SUPERIORITY||Rate Difference|4.9||||0.215|TWO_SIDED|95.0|-3.1|13.0|||Regression, Logistic|||Overall Satisfaction with Medication||13.0|-3.1|0.215
73989161|NCT03151551|147524287|SUPERIORITY||Rate Difference|2.1||||0.561|TWO_SIDED|95.0|-5.5|9.7|||Regression, Logistic|||Mostly Satisfied to any Questions||9.7|-5.5|0.561
74009209|NCT00397033|147569185|SUPERIORITY_OR_OTHER||LS Means Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.029||95.0|-0.7|0.0|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.0|-0.7|0.029
74039659|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2137|TWO_SIDED|95.0|0.91|1.51|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.91|0.2137
74039660|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0256|TWO_SIDED|95.0|1.04|1.72|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.72|1.04|0.0256
74039661|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3531|TWO_SIDED|95.0|0.87|1.46|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.46|0.87|0.3531
74039662|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0358|TWO_SIDED|95.0|1.02|1.7|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|1.02|0.0358
73875763|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.62|||||TWO_SIDED|95.0|32.04|98.31|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 7.||98.31|32.04|
73875764|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.43|||||TWO_SIDED|95.0|59.54|91.58|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 7.||91.58|59.54|
73989162|NCT02979613|147524297|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-1.9|2.0|||||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted Mantel-Haenszel (MH) percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|The null hypothesis was that the TAF group is at least 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48.||2.0|-1.9|
73989163|NCT02979613|147524298|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-1.9|1.9|||||Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||1.9|-1.9|
73989164|NCT02979613|147524298|SUPERIORITY|||||||0.9953||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.9953
73989165|NCT02979613|147524299|NON_INFERIORITY|Non-inferiority was assessed using a 95% CI approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-3.7|3.7|||||Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||3.7|-3.7|
73989166|NCT02979613|147524299|SUPERIORITY|||||||0.98||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.98
74035043|NCT00755846|147622420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|5.16||0.033||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.033
73989167|NCT02979613|147524301|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.9|||||TWO_SIDED|95.0|-3.5|5.2|||||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||5.2|-3.5|
73989168|NCT02979613|147524301|SUPERIORITY|||||||0.6863||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.6863
74035044|NCT00755846|147622421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|17.17||0.897||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.897
74039663|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.22||||0.184|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.91|0.1840
74039664|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.25||||0.125|TWO_SIDED|95.0|0.94|1.67|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.67|0.94|0.1250
73989169|NCT02979613|147524303|SUPERIORITY||Difference in the Percentages|1.4||||0.7258|TWO_SIDED|95.0|-7.2|10.1||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||10.1|-7.2|0.7258
73989170|NCT02979613|147524304|SUPERIORITY||Difference in the Percentages|2.7||||0.1348|TWO_SIDED|95.0|-2.3|7.7||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||7.7|-2.3|0.1348
73989171|NCT02979613|147524305|SUPERIORITY||Difference in the Percentages|9.0||||0.1005|TWO_SIDED|95.0|-2.0|20.1||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||20.1|-2.0|0.1005
73989172|NCT02979613|147524306|SUPERIORITY||Difference in the Percentages|2.5||||0.4154|TWO_SIDED|95.0|-4.5|9.5||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||9.5|-4.5|0.4154
73989173|NCT02979613|147524307|SUPERIORITY||Difference in the Percentages|-2.0||||0.0281|TWO_SIDED|95.0|-4.4|0.3||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||0.3|-4.4|0.0281
73989174|NCT02979613|147524309|SUPERIORITY||Difference in the Percentages|-0.8||||0.5373|TWO_SIDED|95.0|-3.7|2.1||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||2.1|-3.7|0.5373
73989175|NCT02979613|147524310|SUPERIORITY||Difference in the Percentages|0.4||||0.5845|TWO_SIDED|95.0|-1.7|2.5||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||2.5|-1.7|0.5845
73989176|NCT02979613|147524311|SUPERIORITY||Difference in the Percentages|4.5||||0.1405|TWO_SIDED|95.0|-1.6|10.6||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||10.6|-1.6|0.1405
73989177|NCT02979613|147524311|SUPERIORITY||Difference in the Percentages|3.8||||0.3133|TWO_SIDED|95.0|-3.7|11.4||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||11.4|-3.7|0.3133
73989178|NCT02979613|147524312|SUPERIORITY||Difference in the Percentages|14.1||||0.3381|TWO_SIDED|95.0|-16.4|44.6||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory criteria||44.6|-16.4|0.3381
73989179|NCT02979613|147524312|SUPERIORITY||Difference in the Percentages|23.8||||0.0136|TWO_SIDED|95.0|5.3|42.3||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||42.3|5.3|0.0136
73989180|NCT02979613|147524313|SUPERIORITY||Difference in the Percentages|-2.9||||0.2803|TWO_SIDED|95.0|-8.4|2.6||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||2.6|-8.4|0.2803
73989181|NCT02979613|147524313|SUPERIORITY||Difference in the Percentages|-5.9||||0.0788|TWO_SIDED|95.0|-12.6|0.7||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||0.7|-12.6|0.0788
74089899|NCT02312713|147732641|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.72||||0.21|TWO_SIDED|95.0|-1.85|0.41|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Timed Up and Go.||0.41|-1.85|0.21
73989182|NCT02979613|147524314|SUPERIORITY||Difference in the Percentages|-23.9||||0.088|TWO_SIDED|95.0|-51.2|3.4||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||3.4|-51.2|0.0880
74009210|NCT00397033|147569187|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-9.9|-3.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-3.7|-9.9|<0.001
74009211|NCT00397033|147569187|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.5||0.066||95.0|-5.8|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.2|-5.8|0.066
73989183|NCT02979613|147524314|SUPERIORITY||Difference in the Percentages|-18.6||||0.051|TWO_SIDED|95.0|-37.4|0.2||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||0.2|-37.4|0.0510
73989184|NCT02979613|147524315|SUPERIORITY||Difference in LSM|-0.02||||0.0186|TWO_SIDED|95.0|-0.03|0.0|||ANOVA|||P-value, difference in least squares mean (LSM), and its 95% CI were derived from analysis of variance (ANOVA) model with baseline age groups (\< 50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||0.00|-0.03|0.0186
73989185|NCT02979613|147524316|SUPERIORITY||Difference in LSM|0.0||||0.6956|TWO_SIDED|95.0|-0.02|0.01|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||0.01|-0.02|0.6956
73989186|NCT02979613|147524317|SUPERIORITY||Difference in LSM|1.167|||<|0.0001|TWO_SIDED|95.0|0.797|1.536|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.536|0.797|< 0.0001
73989187|NCT02979613|147524318|SUPERIORITY||Difference in LSM|0.977||||0.0002|TWO_SIDED|95.0|0.465|1.49|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.490|0.465|0.0002
73989188|NCT02979613|147524319|SUPERIORITY||Difference in LSM|1.881|||<|0.0001|TWO_SIDED|95.0|1.275|2.486|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||2.486|1.275|< 0.0001
73989189|NCT02979613|147524320|SUPERIORITY||Difference in LSM|0.604||||0.097|TWO_SIDED|95.0|-0.11|1.317|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.317|-0.110|0.0970
73989190|NCT02979613|147524321|SUPERIORITY||||||<|0.0001||||||P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.|Wilcoxon rank sum test|||||||< 0.0001
73989191|NCT02979613|147524322|SUPERIORITY|||||||0.7535||||||P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.|Wilcoxon rank sum test|||||||0.7535
73989192|NCT00143598|147524332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.58|TWO_SIDED|95.0|0.73|1.76|||Regression, Cox|Adjusted for centre||||1.76|.73|.58
73989193|NCT01878383|147524336|OTHER|Sensitivity is the percent of non-pregnant women positive for shedding HSV by culture method in which GeneXpert test results is positive. Units equals percent non-pregnant women positive.|Sensitivity|100.0|||||TWO_SIDED|95.0|90.8|100.0|||||95% Clopper-Pearson Exact Confidence Interval|||100|90.8|
73989194|NCT01878383|147524337|OTHER|Positive percent agreement is the percent of pregnant women with positive routine PCR results in which GeneXpert test results is positive. Units equal percent of pregnant women positive.|Positive percent agreement|80.0|||||TWO_SIDED|95.0|73.7|86.3|||||95% large sample confidence interval|||86.3|73.7|
73989195|NCT01878383|147524338|OTHER|Negative percent agreement is the percent of pregnant women with negative routine PCR results in which GeneXpert test results is negative. Units equal percent of pregnant women negative.|Negative percent agreement|99.2|||||TWO_SIDED|95.0|99.0|99.5|||||95% large sample confidence interval|||99.5|99|
73989196|NCT00469456|147524394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.07||95.0|-0.1|2.8|||ANCOVA|||The primary efficacy parameter was change from Baseline to Week 12 in FLCI total score. Missing FLCI total scores at Week 12 were imputed using the last-observation-carried-forward (LOCF) approach.||2.8|-0.1|0.070
73989197|NCT00469456|147524395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.022||95.0|0.9|10.9|||ANCOVA|||The secondary efficacy parameter was change from Baseline at Week 12 in the total score of the Social Communication subscale and Communication of Basic Needs subscale of the ASHA FACS. Missing scores at week 12 were imputed using the last-observation-carried-forward (LOCF) approach.||10.9|0.9|0.022
73989198|NCT00107978|147524405|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|2.5||||||95.0|-2.9|7.9||p-values were not calculated in deference to confidence intervals.|2-sided 95% confidence interval|2-sided 95% confidence interval calculated on the difference in cure rates between treatment groups.||||7.9|-2.9|
73989199|NCT02669407|147524420|OTHER|Single group|||||<|0.001|||||||Tukey's method|||||||<0.001
74039665|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8266|TWO_SIDED|95.0|0.61|1.48|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.61|0.8266
73989200|NCT02669407|147524421|OTHER|Single group||||||0.001|||||||Tukey's method|||Baseline, 30 minutes||||0.001
73989201|NCT02669407|147524422|OTHER|Single group||||||0.007|||||||Tukey's method|||baseline, 30 minutes||||0.007
73989202|NCT02669407|147524426|OTHER|Single group||||||0.237|||||||t-test, 2 sided|||Change in left ventricular end diastolic dimension||||0.237
73989203|NCT02669407|147524426|OTHER|Single group||||||0.586|||||||t-test, 2 sided|||Change in left ventricular end systolic dimension||||0.586
73989204|NCT02669407|147524427|OTHER|Single group||||||0.175|||||||t-test, 2 sided|||||||0.175
73989205|NCT02669407|147524429|OTHER|Single group||||||0.061|||||||t-test, 2 sided|||||||0.061
73989206|NCT02669407|147524430|OTHER|Single group||||||0.787|||||||t-test, 2 sided|||||||0.787
73989207|NCT02669407|147524432|OTHER|Single group||||||0.606|||||||t-test, 2 sided|||Baseline, 90 minutes||||0.606
74035045|NCT00755846|147622421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|STANDARD_ERROR_OF_MEAN|21.85||0.557||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.557
74035046|NCT00755846|147622421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.5|STANDARD_ERROR_OF_MEAN|22.85||0.616||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.616
74039666|NCT02528253|147632450|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5673|TWO_SIDED|95.0|0.74|1.72|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.72|0.74|0.5673
74089900|NCT02312713|147732642|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.05|TWO_SIDED|95.0|-1.59|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.02|-1.59|0.05
73989208|NCT02669407|147524432|OTHER|Single group||||||0.045|||||||t-test, 2 sided|||Baseline, 24 hours||||0.045
73989209|NCT00704171|147524472|SUPERIORITY_OR_OTHER|||||||0.257|||||||Fisher Exact|||Primary objective was to demonstrate superiority of PleuraSeal as an adjunct compared to standard of care alone. Tissue closure rates for the treatment and control groups were assumed to be 0.40 and 0.15, respectively. To achieve 80 percent power (alpha=0.05, 2-tailed, Fisher's Exact Test) required 112 completed subjects. To account for potential subject withdrawals, an additional 8 subjects were to be enrolled for a total of 120 randomized subjects (approx. 60 per treatment group).||||0.257
73989210|NCT00704171|147524473|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|two-sided||||||<0.001
73989211|NCT00704171|147524474|SUPERIORITY_OR_OTHER|||||||0.79|||||||Kaplan-Meier|Kaplan-Meier method was used to obtain estimated median times for each treatment group and the log-rank test was used to compare the two treatments.||||||0.790
73989212|NCT00704171|147524475|SUPERIORITY_OR_OTHER|||||||0.559|||||||2-sample t-test|||||||0.559
73989213|NCT00704171|147524476|SUPERIORITY_OR_OTHER|||||||0.292|||||||2-sample t-test|||||||0.292
73989214|NCT00704171|147524477|SUPERIORITY_OR_OTHER|||||||0.53||||||For subgroup with pre-randomization air leak grade of 1|Fisher Exact|||||||0.53
73989215|NCT00704171|147524477|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||For subgroup with pre-randomization air leak grade of 2 or 3|Fisher Exact|||||||.013
73989216|NCT03634839|147524498|SUPERIORITY||Mean Difference (Final Values)|-5.184||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||0.053
74039667|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0076|TWO_SIDED|95.0|1.12|2.08|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.08|1.12|0.0076
74039668|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.98|||<|0.0001|TWO_SIDED|95.0|1.46|2.69|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.69|1.46|<.0001
74039669|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.31||||0.07|TWO_SIDED|95.0|0.98|1.74|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.74|0.98|0.0700
74089901|NCT02312713|147732642|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.05|TWO_SIDED|95.0|-1.82|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.02|-1.82|0.05
74089902|NCT02312713|147732642|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.19|TWO_SIDED|95.0|-1.37|0.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.27|-1.37|0.19
74089903|NCT02312713|147732642|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.06|TWO_SIDED|95.0|-1.83|0.05|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.05|-1.83|0.06
73989217|NCT03634839|147524499|SUPERIORITY||Mean Difference (Final Values)|-1.881||||0.187|TWO_SIDED||||||t-test, 2 sided|||Outcome analyses will be intent-to-treat and using mixed-effects models with flavor as a within-subject factor. A significant main effect of flavor with greater liking of sweet plus cooling flavor than sweet minus cooling flavor will be considered supportive of our hypotheses.||||0.187
73989218|NCT03634839|147524500|SUPERIORITY||Mean Difference (Final Values)|-0.286||||0.135|TWO_SIDED||||||t-test, 2 sided|||||||0.135
73989219|NCT03634839|147524501|SUPERIORITY||Mean Difference (Final Values)|1.942||||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.210
73989220|NCT02447432|147524502|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.09|||||TWO_SIDED|95.0|0.89|1.33||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-1 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.33|0.89|
73989221|NCT02447432|147524502|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.92|||||TWO_SIDED|95.0|0.75|1.12||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-4 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.12|0.75|
73989222|NCT02447432|147524502|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.03|||||TWO_SIDED|95.0|0.85|1.26||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-5 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.26|0.85|
73989223|NCT02447432|147524502|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.12|||||TWO_SIDED|95.0|0.78|1.61||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-6B serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.61|0.78|
73989224|NCT02447432|147524502|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.05|||||TWO_SIDED|95.0|0.88|1.25||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-7F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.25|0.88|
73989225|NCT02447432|147524502|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.88|||||TWO_SIDED|95.0|0.69|1.13||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-9V serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.13|0.69|
73989226|NCT02447432|147524502|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.98|||||TWO_SIDED|95.0|0.73|1.31||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-14 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.31|0.73|
73989227|NCT02447432|147524502|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.08|||||TWO_SIDED|95.0|0.86|1.37||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-18C serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.37|0.86|
73989228|NCT02447432|147524502|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.99|||||TWO_SIDED|95.0|0.78|1.25||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-19F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.25|0.78|
73989229|NCT02447432|147524502|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.28|||||TWO_SIDED|95.0|0.92|1.8||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-23F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.80|0.92|
74009212|NCT01984164|147569188|SUPERIORITY||Treatment effect size|-13.6|||||TWO_SIDED|95.0|-23.6|-3.7|||||effect size p-value = 0.008|All analyses were conducted using the intention-to-treat principle. Results are provided as adjusted least-square means with SE and effect size (ES) estimates (calculated from mixed model with repeated measures (MMRM) as the adjusted difference in cognitive change between the 2 groups over the study period).||-3.7|-23.6|
74009213|NCT05293743|147569203|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.67||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 3.82.||The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by parent-reported brace logs.||||0.67
74039670|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2655|TWO_SIDED|95.0|0.89|1.54|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.54|0.89|0.2655
73989230|NCT04198948|147524519|EQUIVALENCE|Sample size calculation was performed using SAS Proc Power procedure for equivalence test in 2x2 crossover design. For an equivalence range of 80-125%, the within-subject coefficient of variation for the AUC values for gliclazide of 7.8% based on previous PK studies, and expected test/reference geometric mean ratios between 87-115%, 14 volunteers (7 individuals per sequence) are required to show the lack of interaction with 85% power.|Geometric least square mean ratio|1.13|||||TWO_SIDED|90.0|0.86|1.48|||||The TOST (two one-sided test) test of equivalence showed that the geometric mean ratio and 90% CI for gliclazide AUC(0-24) between omeprazole and placebo phase was 1.13 (0.86-1.48), with upper confidence limit above the usual 1.25 boundary.|The main evaluated outcome was systemic exposure to gliclazide, expressed as AUC(0-t). The geometric mean was calculated for gliclazide AUC(0-24). The ratio of the geometric means with 90% CIs was assessed by linear mixed models between the two treatment assignments: gliclazide and omeprazole co-administration to that of gliclazide and placebo. The obtained 90% CI was compared with the equivalence 0.8-1.25 range.||1.48|0.86|
73989231|NCT04198948|147524520|SUPERIORITY|||||||0.636|||||||t-test, 2 sided|||||||0.636
73989232|NCT04198948|147524521|SUPERIORITY|||||||0.055|||||||t-test, 2 sided|||||||0.055
73989233|NCT00913068|147524526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Chi-squared|||||||0.0012
73989234|NCT04269434|147524633|NON_INFERIORITY|"The No Screening Arm is considered non-inferior if the upper limit of the 95% Confidence Interval is less than 1.25"|Incidence rate ratio|1.318|||||TWO_SIDED|95.0|1.068|1.627||||||Compared to screening group||1.627|1.068|
73989235|NCT04269434|147524634|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.788|||||TWO_SIDED|95.0|0.719|0.863||||||For Azithromycin. Compared to screening group||0.863|0.719|
73989236|NCT04269434|147524634|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.561|||||TWO_SIDED|95.0|0.426|0.739||||||For Ceftriaxone. Compared to screening group||0.739|0.426|
73989237|NCT04269434|147524634|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.55|||||TWO_SIDED|95.0|0.515|0.588||||||For Doxycycline. Compared to screening group||0.588|0.515|
73989238|NCT04269434|147524635|NON_INFERIORITY|No prespecified margin.|Incidence rate ratio|1.373|||||TWO_SIDED|95.0|0.963|1.956||||||Compared to screening group||1.956|0.963|
73989239|NCT04269434|147524636|NON_INFERIORITY|No prespecified margin.|Incidence rate ratio|1.471|||||TWO_SIDED|95.0|0.943|2.299||||||Compared to screening group||2.299|0.943|
73989240|NCT04962698|147524637|SUPERIORITY||||||>|0.00238||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||>0.00238
73989241|NCT04962698|147524638|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was 0.05.|ANOVA|||||||<0.001
73989242|NCT04962698|147524639|SUPERIORITY|||||||0.028||||||The threshold for statistical significance was 0.05.|ANOVA|||||||0.028
73989243|NCT04962698|147524640|SUPERIORITY||||||<|0.00231||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||<0.00231
73989244|NCT04962698|147524641|SUPERIORITY||||||<|0.002||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||<0.0020
73989245|NCT01664923|147524647|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.181|0.32||P-value based on log-rank test stratified by disease stage at study entry as reported on the case report form (CRF).|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.320|0.181|<0.0001
73989246|NCT01664923|147524648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.137|0.264||P-value based on log-rank test stratified by disease stage at study entry as reported on the CRF.|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.264|0.137|<0.0001
73989247|NCT01664923|147524649|SUPERIORITY_OR_OTHER||Difference in rates|50.0|||<|0.0001|TWO_SIDED|95.0|41.4|58.5|||Cochran-Mantel-Haenszel|Comparison of the 2 treatment groups using the Cochran-Mantel-Haenszel mean score test stratified by disease stage at study entry.|Enzalutamide response rate minus bicalutamide response rate.|||58.5|41.4|<0.0001
73989248|NCT01664923|147524650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.324|||<|0.0001|TWO_SIDED|95.0|0.211|0.497|||Log Rank|P-value is based on an unstratified log-rank test.|Hazard ratio is based on an unstratified Cox-regression model (with treatment as the only covariate) and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.497|0.211|<0.0001
73989249|NCT01664923|147524651|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.4945|TWO_SIDED|95.0|0.695|1.192||This secondary endpoint was not adjusted for multiple comparisons.|Log Rank|P-value is based on a log-rank test stratified by disease stage at study entry.|Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||1.192|0.695|0.4945
73989250|NCT01664923|147524652|SUPERIORITY_OR_OTHER||Difference in objective response rate|46.05|||<|0.0001|TWO_SIDED|95.0|26.79|65.3||This secondary endpoint was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Based on unstratified Cochran-Mantel-Haenszel mean score test.||||65.30|26.79|<0.0001
73989251|NCT02367105|147524654|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.58|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariate||||||0.58
73989252|NCT02367105|147524655|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.03
73989253|NCT02367105|147524656|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.97|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||.97
73989254|NCT02367105|147524657|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.56|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.56
74089904|NCT02312713|147732642|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.23||||0.49|TWO_SIDED|95.0|-0.43|0.89|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||0.89|-0.43|0.49
73989255|NCT02367105|147524658|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
73989256|NCT02367105|147524659|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
73989257|NCT02367105|147524660|SUPERIORITY||Mean Difference (Final Values)|-42.0||||0.04|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.04
73989258|NCT02367105|147524661|SUPERIORITY||Mean Difference (Final Values)|-29.0||||0.67|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||.67
73989259|NCT02367105|147524662|SUPERIORITY||Mean Difference (Final Values)|-0.019||||0.003|TWO_SIDED||||||Mixed Models Analysis|Baseline valued adjusted||||||0.003
73989260|NCT02367105|147524663|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.69
73989261|NCT02367105|147524664|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.94|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.94
73989262|NCT02367105|147524665|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.41|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.41
73989263|NCT02367105|147524666|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.46|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.46
73989264|NCT02367105|147524667|SUPERIORITY|Baseline value adjusted|Mean Difference (Final Values)|0.6||||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||0.96
73989265|NCT02367105|147524668|SUPERIORITY||Mean Difference (Final Values)|-0.284||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||.003
73989266|NCT02367105|147524669|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.16|TWO_SIDED||||||Mixed Models Analysis|Baseline value and years of education as covariates||||||.16
74089905|NCT02312713|147732642|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.77|0.78|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.78|-0.77|0.99
73989267|NCT02367105|147524670|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.21|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.21
73989268|NCT02367105|147524671|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.41|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.41
73989269|NCT02367105|147524672|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value and years if education as covariates||||||.03
73989270|NCT02367105|147524673|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||.03
73989271|NCT02367105|147524674|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.18|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||.18
73989272|NCT02367105|147524675|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.1|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.10
73989273|NCT02367105|147524676|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.65|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||.65
73989274|NCT02367105|147524677|SUPERIORITY||Mean Difference (Final Values)|0.553||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.03
73989275|NCT02367105|147524678|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.04|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.04
73989276|NCT02367105|147524679|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.35|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.35
73989277|NCT02367105|147524680|SUPERIORITY||Median Difference (Final Values)|0.01||||0.65|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.65
73989278|NCT02367105|147524681|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.27|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.27
73989279|NCT02367105|147524682|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.39|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.39
73989280|NCT02367105|147524683|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
73989281|NCT02367105|147524684|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.9|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.90
73989282|NCT02367105|147524685|SUPERIORITY||Mean Difference (Final Values)|-252.0|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||<0.001
73989283|NCT02367105|147524686|SUPERIORITY||Mean Difference (Final Values)|-24.9|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline value as covariates||||||<0.001
73989284|NCT02367105|147524687|SUPERIORITY||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||<0.001
73989285|NCT02367105|147524688|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.31|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.31
73989286|NCT02367105|147524689|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.42|TWO_SIDED|||||Baseline values as covariates|Mixed Models Analysis|||||||0.42
73989287|NCT02367105|147524690|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.69
73989288|NCT02367105|147524691|SUPERIORITY||Mean Difference (Final Values)|-13.1||||0.23|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.23
73989289|NCT02367105|147524692|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
73989290|NCT02367105|147524693|SUPERIORITY||Mean Difference (Net)|-1.0||||0.36|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.36
73989291|NCT02367105|147524694|SUPERIORITY||Mean Difference (Final Values)|-8.6||||0.23|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.23
73989292|NCT02367105|147524695|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline values adjusted||||||0.69
73989293|NCT02367105|147524696|SUPERIORITY||Number of participants|0.0|||>|0.05|TWO_SIDED|||||A priori threshold = voxel p\<.001, cluster p\<.05, false discovery rate (FDR) whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design.|t-test, 2 sided|||||||>.05
73989294|NCT02367105|147524697|SUPERIORITY||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED|||||Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate.|t-test, 2 sided|||6 months vs Baseline||||0.37
73989295|NCT02367105|147524697|SUPERIORITY||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.12||0.02|TWO_SIDED|||||Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate|t-test, 2 sided|||6 months vs Baseline||||.02
73989296|NCT02367105|147524698|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.05|TWO_SIDED||||||Mixed Models Analysis|Final vs baseline||||||.05
73989297|NCT02367105|147524698|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.3|TWO_SIDED||||||Mixed Models Analysis|Final vs baseline||||||0.3
73989298|NCT01657877|147524703|NON_INFERIORITY_OR_EQUIVALENCE|The success criterion for this study was to observe the upper bound of the 2-sided 95% confidence interval for difference in % change in SMHR to be \<= 6 units SMHR i.e. 1500 ppm fluoride as SMFP + 5% CSP is no more than 6 units inferior to the 1500 ppm fluoride as SMFP + 0 % CSP dentifrice.|Adjusted mean difference|-2.23||||0.2601|TWO_SIDED|95.0|-6.11|1.66|||ANOVA|Based on the mixed effects ANOVA considering treatment and study period as factors, and subject as random effect|Difference is 1500 ppm fluoride as SMFP and 0 % CSP minus 1500 ppm fluoride as SMFP and 5 % CSP such that a positive difference favors 1500 ppm fluoride as SMFP and 0 % CSP|The null hypothesis states that the population mean for the 1500 ppm fluoride as SMFP + 0% CSP minus the population mean for the 1500 ppm fluoride as SMFP and 5% CSP dentifrice is more than 6 %.||1.66|-6.11|0.2601
73875765|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|78.79|||||TWO_SIDED|95.0|51.24|92.08|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 7.||92.08|51.24|
73989299|NCT02586415|147524756|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.63|4.7||Criteria to assess superiority was a two-sided P value of \<0.05. The study was terminated early because the pre-specified stopping boundary of P \<0.0025 was crossed at the first interim analysis (N=182)|Cochran-Mantel-Haenszel|||||4.70|1.63|<0.001
73989300|NCT00878553|147524808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.606|STANDARD_ERROR_OF_MEAN|2.42||0.0118|TWO_SIDED|95.0|-15.284|-1.927||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes||-1.927|-15.284|0.0118
73989301|NCT00878553|147524808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.98|STANDARD_ERROR_OF_MEAN|2.421||0.0037|TWO_SIDED|95.0|-16.685|-3.275||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes||-3.275|-16.685|0.0037
73989302|NCT00878553|147524808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.153|STANDARD_ERROR_OF_MEAN|2.422||0.0077|TWO_SIDED|95.0|-15.857|-2.448||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo.|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05.|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 20-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||-2.448|-15.857|0.0077
74039671|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0022|TWO_SIDED|95.0|1.16|1.98|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.98|1.16|0.0022
74039672|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0125|TWO_SIDED|95.0|1.11|2.35|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.35|1.11|0.0125
73875766|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.76|||||TWO_SIDED|95.0|65.98|92.14|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 8.||92.14|65.98|
73875767|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|42.67|98.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 8.||98.52|42.67|
73875768|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.62|||||TWO_SIDED|95.0|32.04|98.31|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 8.||98.31|32.04|
73875769|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|81.4|||||TWO_SIDED|95.0|59.97|92.45|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 8.||92.45|59.97|
73875770|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.65|||||TWO_SIDED|95.0|52.91|93.4|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 8.||93.40|52.91|
73875771|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|73.68|||||TWO_SIDED|95.0|52.89|86.16|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 9.||86.16|52.89|
73875772|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|66.67|||||TWO_SIDED|95.0|3.52|90.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 9.||90.52|3.52|
73989303|NCT00878553|147524809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.604|STANDARD_ERROR_OF_MEAN|2.755||0.1476|TWO_SIDED|95.0|-13.208|2.0||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||2.000|-13.208|0.1476
73875773|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|72.73|||||TWO_SIDED|95.0|-3.24|95.11|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 9.||95.11|-3.24|
73989304|NCT00878553|147524809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.912|STANDARD_ERROR_OF_MEAN|2.757||0.0757|TWO_SIDED|95.0|-14.546|0.722||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||0.722|-14.546|0.0757
74039673|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0032|TWO_SIDED|95.0|1.21|2.54|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.54|1.21|0.0032
73875774|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|76.19|||||TWO_SIDED|95.0|51.78|89.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 9.||89.35|51.78|
73875775|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|75.86|||||TWO_SIDED|95.0|43.69|91.07|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 9.||91.07|43.69|
73875776|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|71.7|||||TWO_SIDED|95.0|49.03|85.18|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 10.||85.18|49.03|
73875777|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|77.89|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 10.||100.00|77.89|
73875778|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.0|||||TWO_SIDED|95.0|29.71|99.77|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 10.||99.77|29.71|
73989305|NCT00878553|147524809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.521|STANDARD_ERROR_OF_MEAN|2.757||0.1553|TWO_SIDED|95.0|-13.154|2.113||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||2.113|-13.154|0.1553
73989306|NCT00878553|147524810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.831|STANDARD_ERROR_OF_MEAN|2.4||0.0092|TWO_SIDED|95.0|2.208|15.454||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||15.454|2.208|0.0092
73989307|NCT00878553|147524810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.425|STANDARD_ERROR_OF_MEAN|2.402||0.0023|TWO_SIDED|95.0|3.775|17.075||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||17.075|3.775|0.0023
73989308|NCT00878553|147524810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.147|STANDARD_ERROR_OF_MEAN|2.402||0.003|TWO_SIDED|95.0|3.498|16.796||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||16.796|3.498|0.0030
73989309|NCT00878553|147524811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.562|STANDARD_ERROR_OF_MEAN|0.244||0.1005|TWO_SIDED|95.0|-1.235|0.11||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||0.110|-1.235|0.1005
73875779|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|60.53|||||TWO_SIDED|95.0|26.55|79.83|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 10.||79.83|26.55|
73989310|NCT00878553|147524811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.037|STANDARD_ERROR_OF_MEAN|0.244||0.0028|TWO_SIDED|95.0|-1.712|-0.362||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||-0.362|-1.712|0.0028
73989311|NCT00878553|147524811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.793|STANDARD_ERROR_OF_MEAN|0.244||0.0216|TWO_SIDED|95.0|-1.467|-0.118||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustments for multiple testing were made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||-0.118|-1.467|0.0216
73989312|NCT00878553|147524812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.452|STANDARD_ERROR_OF_MEAN|0.219||0.219|TWO_SIDED|95.0|-21.98|5.077||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||5.077|-21.980|0.2190
73989313|NCT00878553|147524812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.365|STANDARD_ERROR_OF_MEAN|4.937||0.8441|TWO_SIDED|95.0|-12.327|15.056||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A positive mean change from baseline indicates a worsening.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||15.056|-12.327|0.8441
73989314|NCT00878553|147524812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.84|STANDARD_ERROR_OF_MEAN|4.936||0.0894|TWO_SIDED|95.0|-25.522|1.842||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||1.842|-25.522|0.0894
73989315|NCT00878553|147524813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|1.469||0.6433|TWO_SIDED|95.0|-1.823|2.943||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||2.943|-1.823|0.6433
73989316|NCT00878553|147524813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.912|STANDARD_ERROR_OF_MEAN|1.523||0.1167|TWO_SIDED|95.0|-4.304|0.481||Analysis included effects for patient, period, sequence and treatment|Mixed Models Analysis||A negative mean difference from baseline indicates a worsening.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||0.481|-4.304|0.1167
73989317|NCT00878553|147524813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.434|STANDARD_ERROR_OF_MEAN|1.626||0.2385|TWO_SIDED|95.0|-0.958|3.826||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||3.826|-0.958|0.2385
73989318|NCT00878553|147524814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.256||0.0914|TWO_SIDED|95.0|-0.073|0.972|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.972|-0.073|0.0914
74039674|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1528|TWO_SIDED|95.0|0.91|1.85|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.85|0.91|0.1528
73875780|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|48.15|||||TWO_SIDED|95.0|-2.41|74.87|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 10.||74.87|-2.41|
73989319|NCT00878553|147524814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.165|STANDARD_ERROR_OF_MEAN|0.259||0.536|TWO_SIDED|95.0|-0.36|0.69|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.690|-0.360|0.5360
73989320|NCT00878553|147524814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262|STANDARD_ERROR_OF_MEAN|0.237||0.3254|TWO_SIDED|95.0|-0.787|0.263|||Mixed Models Analysis||A negative mean change from baseline indicates a worsening.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.263|-0.787|0.3254
73989321|NCT00878553|147524815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|1.818||0.719|TWO_SIDED|95.0|-3.175|4.595||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates improvement.|||4.595|-3.175|0.7190
73989322|NCT00878553|147524815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.821|STANDARD_ERROR_OF_MEAN|2.422||0.6784|TWO_SIDED|95.0|-3.08|4.722||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.|||4.722|-3.080|0.6784
73989323|NCT00878553|147524815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.314|STANDARD_ERROR_OF_MEAN|2.058||0.2433|TWO_SIDED|95.0|-1.586|6.214||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.|||6.214|-1.586|0.2433
73989324|NCT00878553|147524816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.39||||0.0009|TWO_SIDED||||||ANOVA|F-test 2 degrees of freedom||Cmax(ng/mL) \[Maximum plasma zaleplon concentration\]||||0.0009
73989325|NCT00878553|147524817|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.9142||95.0|||||ANOVA|F-test two degrees of freedom||Cmax normalized per dose||||0.9142
73989326|NCT00878553|147524818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.24||||0.1193||95.0|||||ANOVA|F-test 2 degrees of freedom||Time (hour)post-dose of maximum plasma zaleplon concentration||||0.1193
73989327|NCT00878553|147524819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.85||||0.0003||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC ng\*h/mL)||||0.0003
73989328|NCT00878553|147524820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.28||||0.2281||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC/Dose (ng\*h/mL/mg)||||0.2281
73989329|NCT00878553|147524821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.4835||95.0|||||ANOVA|2 degrees of freedom F-test||Half-Life (t1/2 in hours) of plasma zaleplon from each of 3 doses of SKP-1041||||0.4835
73989330|NCT00461123|147524835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.5248||95.0|-4.18|8.05|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of least squares (LS) means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||8.05|-4.18|0.5248
73875781|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.0|||||TWO_SIDED|95.0|63.03|92.22|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 11.||92.22|63.03|
73989331|NCT00461123|147524836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.87||95.0|-3.58|3.04|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||3.04|-3.58|0.8700
73989332|NCT00461123|147524837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.57||||0.4162||95.0|-8.21|19.35|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||19.35|-8.21|0.4162
73989333|NCT00461123|147524838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0588||95.0|-13.25|0.26|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||0.26|-13.25|0.0588
73989334|NCT00461123|147524839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.61||||0.7878||95.0|-22.03|16.82|||ANCOVA|Analysis of variance (ANOVA), treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group||16.82|-22.03|0.7878
73989335|NCT03029819|147524846|SUPERIORITY|||||||0.52|||||||Chi-squared|||||||.52
73989336|NCT03605368|147524869|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.13||0.23|TWO_SIDED||||||Regression, Linear|||Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.23
73989337|NCT03605368|147524869|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.07
73989338|NCT03605368|147524869|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.99|TWO_SIDED||||||Regression, Linear|||Orienting. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.99
74089906|NCT02312713|147732643|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.57||||0.36|TWO_SIDED|95.0|-1.77|4.92|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Pain.||4.92|-1.77|0.36
74089907|NCT02312713|147732643|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.51||||0.17|TWO_SIDED|95.0|-1.11|6.14|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months for KOOS Pain.||6.14|-1.11|0.17
74089908|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|3.94||||0.06|TWO_SIDED|95.0|-0.19|8.06|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Pain.||8.06|-0.19|0.06
74089909|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|3.36||||0.14|TWO_SIDED|95.0|-1.08|7.79|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Pain.||7.79|-1.08|0.14
74089910|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|2.37||||0.25|TWO_SIDED|95.0|-1.67|6.4|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 4 months for KOOS Pain.||6.4|-1.67|0.25
74089911|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.7|TWO_SIDED|95.0|-3.48|5.18|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 12 months for KOOS Pain.||5.18|-3.48|0.70
74089912|NCT02312713|147732643|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-1.32||||0.4|TWO_SIDED|95.0|-4.43|1.79|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS ADL.||1.79|-4.43|0.40
73989339|NCT03605368|147524869|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.16||0.005|TWO_SIDED||||||Regression, Linear|||Fidget. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.005
73989340|NCT03605368|147524869|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.11||0.01|TWO_SIDED||||||Regression, Linear|||Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.01
73989341|NCT03605368|147524869|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.09||0.04|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.04
73989342|NCT03605368|147524869|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.06|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.06
73989343|NCT03605368|147524869|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.14||0.09|TWO_SIDED||||||Regression, Linear|||||||.09
74089913|NCT02312713|147732643|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.84|TWO_SIDED|95.0|-2.93|3.59|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS ADL.||3.59|-2.93|0.84
74089914|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|2.11||||0.28|TWO_SIDED|95.0|-1.73|5.94|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 month for KOOS ADL.||5.94|-1.73|0.28
73989344|NCT03605368|147524870|EQUIVALENCE|A linear regression compared change in Police Interaction Knowledge scores by group (Floreo vs. TAU) from pre- to post-intervention. Significance was set at p\<.05.|Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|2.67||0.55|TWO_SIDED||||||Regression, Linear|||||||.55
73989345|NCT03605368|147524870|EQUIVALENCE|A linear regression compared change in Police Interaction Knowledge scores by group (Floreo vs. TAU) from pre- to post-intervention. Significance was set at p\<.05.|Mean Difference (Final Values)|5.42|STANDARD_ERROR_OF_MEAN|2.73||0.05|TWO_SIDED||||||Regression, Linear|||||||.05
73989346|NCT03559829|147524874|OTHER|||||||0.025|||||||paired t-test|||||||0.025
73989347|NCT03559829|147524875|OTHER|||||||0.01|||||||paired t-test|||||||0.01
73989348|NCT03559829|147524876|OTHER|||||||0.3|||||||paired t-test|||||||0.3
73989349|NCT03559829|147524877|OTHER|||||||0.098|||||||paired t-test|||||||0.098
73989350|NCT03559829|147524878|OTHER|||||||0.2|||||||paired t-test|||||||0.2
73989351|NCT03559829|147524879|OTHER|||||||0.07|||||||paired t-test|||||||0.07
74089915|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|2.79||||0.17|TWO_SIDED|95.0|-1.2|6.77|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 month for KOOS ADL.||6.77|-1.2|0.17
74089916|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|3.43||||0.07|TWO_SIDED|95.0|-0.32|7.18|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS ADL.||7.18|-0.32|0.07
73989352|NCT04088136|147524911|EQUIVALENCE|A one-tailed independent samples t-test was conducted. A p-value of .05 was used to determine statistical significance.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.67|TWO_SIDED|95.0|-0.42|0.55|||t-test, 2 sided|Use of pooled error term, df = 60.|Negative number reflects fewer errors in EMMI group, as predicted.|||0.55|-0.42|.67
73989353|NCT04088136|147524912|SUPERIORITY|Everyday Metacognitive Memory group predicted to have superior scores to Memory Strategy Control|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.47|TWO_SIDED||||||t-test, 1 sided||pooled error term, equal variance assumption, df = 60|||||<.47
74035047|NCT00755846|147622421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|21.73||0.679||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.679
74035048|NCT00755846|147622421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|21.94||0.697||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.697
74035049|NCT00755846|147622421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|22.03||0.672||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.672
74035050|NCT00755846|147622422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|16.37||0.809||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.809
74035051|NCT00755846|147622422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|20.74||0.597||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.597
74035052|NCT00755846|147622422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|21.77||0.982||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.982
73989354|NCT04088136|147524913|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.0|<|0.13|TWO_SIDED|95.0|-3.7|7.6|||t-test, 1 sided|||||7.6|-3.7|< .13
73989355|NCT04088136|147524914|EQUIVALENCE|Directional hypothesis of fewer errors in Everyday Metacognitive Memory group|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.8||0.57|TWO_SIDED|95.0|-4.8|2.6||A p-value of .05 was used to determine statistical significance.|t-test, 2 sided|Pooled error term, df = 51||||2.6|-4.8|.57
74035053|NCT00755846|147622422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.0|STANDARD_ERROR_OF_MEAN|20.62||0.358||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.358
74089917|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|2.45||||0.22|TWO_SIDED|95.0|-1.44|6.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS ADL.||6.34|-1.44|0.22
73989356|NCT04088136|147524915|EQUIVALENCE|Two-tailed test of hypothesis of fewer errors in EMMI group|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.3||0.72|TWO_SIDED|95.0|-3.8|5.5||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Pooled error term, df = 49||||5.5|-3.8|.72
73989357|NCT04088136|147524916|OTHER|Test of Group X Time interaction|||||<|0.69|||||||Mixed Models Analysis|pooled df = 59||"We ran a 2 X 2 (Group X Time) mixed model analysis with repeated measures on Time (pretest, posttest).~Hypothesis was that Memory Strategy Control group would show greater improvements from pretest to posttest in recall scores"||||< .69
73989358|NCT04088136|147524917|OTHER|One-tailed test of Group X Time interaction|||||<|0.037|||||||Mixed Models Analysis|||"We ran a 2 X 2 (Group X Time) mixed effect model with repeated measures on Time (pretest-posttest).~Predicted hypothesis was greater pretest-posttest improvement in the Memory Strategy Contol group"||||< .037
73989359|NCT04088136|147524918|OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|9.9||0.69|TWO_SIDED|95.0|-4.0|8.4|||t-test, 2 sided||one instance of missing data due to computer failure during testing. Pooled error term resulting in df = 59|||8.4|-4.0|.69
73989360|NCT04088136|147524919|EQUIVALENCE|Directional hypothesis of shorter time in Everyday Metacognitive Memory group|Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|103.3||0.63|TWO_SIDED|95.0|-257.4|157.4||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Use of pooled error term, DF = 51||||157.4|-257.4|.63
73875782|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|42.67|98.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 11.||98.52|42.67|
73989361|NCT04088136|147524920|EQUIVALENCE|Two-tailed test of hypothesis of shorter time in Everyday Metacognitive Memory group|Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|43.8||0.81|TWO_SIDED|95.0|-77.4|98.5||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Use of pooled error term, df = 49||||98.5|-77.4|.81
73989362|NCT04088136|147524921|OTHER||||||<|0.14|||||||Mixed Models Analysis|mixed procedure with unrestricted error covariance matrix. Pooled df for MSWithin = 60||We conducted a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest). Hypothesis was greater reduction in memory complaints from pretest to posttest in EMMI group||||< .14
73875783|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|65.07|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 11.||100.00|65.07|
73875784|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|79.41|||||TWO_SIDED|95.0|52.82|92.3|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 11.||92.30|52.82|
73875785|NCT02723773|147293529|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|72.0|||||TWO_SIDED|95.0|33.41|89.77|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 11.||89.77|33.41|
73875786|NCT02723773|147293530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.5|||||TWO_SIDED|95.0|64.75|96.79|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=50 YOA Group over Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control \>=50 YOA Group and Historical Control\>=50 YOA Group.||96.79|64.75|
73875787|NCT02723773|147293530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|46.59|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.||100.00|46.59|
73989363|NCT04088136|147524922|OTHER|||||||0.037|||||||Mixed Models Analysis|||We ran a 2 X 2 (Group X Time) mixed effect model with repeated measures on Time (pretest-posttest)||||.037
73989364|NCT04088136|147524923|OTHER|Hypothesis was greater increase in memory self-efficacy for Everyday Metacognitive Memory group|||||<|0.33|||||||Mixed Models Analysis|mixed model specified unrestricted residual (error) covariance matrix. Pooled df in MS Error = 60||We ran a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest).||||< .33
73989365|NCT04088136|147524924|OTHER||||||<|0.2|||||||Mixed Models Analysis|||We ran a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest). Hypothesis was greater increase in memory control in EMMI group||||< .20
73989366|NCT04088136|147524925|OTHER|Hypothesis was greater increase in use of external mnemonics in EMMI group|||||<|0.2|||||||Mixed Models Analysis|||||||< .20
73989367|NCT02250183|147524945|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Each case (participant) serves as its own control because they received both treatment modalities simultaneously.|McNemar|McNemar test was used because participants received both treatments, so this variable was non-independent in our single group sample.|2-sided|Each participant received both treatment modalities - MEDIHONEY® and SANTYL - and thus had two wound cultures performed, one for each treatment modality. This was a single group study; however, wound culture results were contrasted with each other across participants. Thus, independent variable was treatment modality, while dependent variable was the wound culture result (positive for presence of bacteria versus negative for absence of bacteria).||||1.00
73989368|NCT02250183|147524946|SUPERIORITY||Mean Difference (Final Values)|3.615|STANDARD_ERROR_OF_MEAN|0.79||0.003|TWO_SIDED|95.0|1.149|4.565||The null hypothesis was that the two mean scores would not differ significantly at p\<.05 level.|t-test, 2 sided|df = 13||A paired samples, 2-tailed, t-test was used to compare means within participants for ratings of MEDIHONEY and SANTYL satisfaction total scores. The null hypothesis was that the two mean scores would not differ significantly at p\<.05 level.||4.565|1.149|.003
73989369|NCT05896696|147524948|OTHER||Mean Difference (Final Values)|-1.87|||<|0.0001|TWO_SIDED|95.0|-2.49|-1.26|||Paired sample t-test|||||-1.26|-2.49|<0.0001
73989370|NCT05896696|147524949|OTHER||Mean Difference (Final Values)|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.73|||paired sample t-test|||||-0.73|-1.70|<0.0001
73989371|NCT02080403|147524974|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.1159|TWO_SIDED|95.0|-0.4|0.04|||Mixed Models Analysis|||||0.04|-0.40|0.1159
73989372|NCT00760513|147525065|SUPERIORITY||Mean Difference (Net)|-1.7||||0.48|TWO_SIDED|95.0|-6.3|3.0||The a priori threshold for statistical significance = P\</=0.05|Regression, Linear|Adjusted for baseline value of liver fat percentage||We estimated that a 20% decrease in liver fat with Omacor treatment, assuming a sigma of 0.3, and an alpha of 0.05; with 91 participants completing our trial, we had 86% power to detect a 20% change in liver fat (two tailed test) (see HEPATOLOGY 2014;60:1211-1221).||3.0|-6.3|0.48
73989373|NCT00760513|147525066|SUPERIORITY||Mean Difference (Net)|-0.001||||1|TWO_SIDED|95.0|-0.3|0.3||A priori p value threshold \</=0.5|Regression, Linear|Adjusted for baseline||Based on the available evidence at the time, we assumed that a 0.6-1.0 unit change in fibrosis score might be clinically significant (Hepatology 2008 Feb;47(2):455-460). Consequently, to detect a minimum 0.6 unit change in score (e.g. 9.0 at baseline and 8.4 at the end of the study) with an SD of 1.0, 100 participants would provide \>80% power at the 5% significance level, and with a 15% drop out of participants there would also be \>80% power to detect this effect.||0.3|-0.3|1.0
73875788|NCT02723773|147293530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|50.0|||||TWO_SIDED|95.0|-860.45|99.15|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||99.15|-860.45|
73875789|NCT02723773|147293530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.0|||||TWO_SIDED|95.0|53.66|95.95|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=60 YOA Group over Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of PHN between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||95.95|53.66|
73875790|NCT02723773|147293530|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.96|||||TWO_SIDED|95.0|56.83|97.49|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=70 YOA Group over Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of PHN between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||97.49|56.83|
73875791|NCT02723773|147293531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.69|||||TWO_SIDED|95.0|78.67|95.7|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group.||95.70|78.67|
73875792|NCT02723773|147293531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|77.79|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||100.00|77.79|
73989374|NCT00760513|147525067|SUPERIORITY||Mean Difference (Net)|-0.03||||0.9|TWO_SIDED|95.0|-0.4|0.3||A priori threshold for statistical significance p \</=0.05|Regression, Linear|Adjusted for baseline measurement.||There was no power calculation for this end point.||0.3|-0.4|0.9
74089918|NCT02312713|147732643|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.21||||0.92|TWO_SIDED|95.0|-4.47|4.06|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Sport/Rec.||4.06|-4.47|.92
74089919|NCT02312713|147732643|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.55||||0.82|TWO_SIDED|95.0|-4.15|5.24|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS Sport/Rec.||5.24|-4.15|.82
73989375|NCT01468077|147525089|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0164|||||TWO_SIDED|95.0|-0.2685|0.2988|||||The CI (confidence interval) is calculated by Exact method based on binomial distribution.|||0.2988|-0.2685|
73989376|NCT00004146|147525109|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.65|1.12|||t-test, 1 sided|||the study design is to detect 30% reduction in hazard of deaths with 78% power at one side alpha level of 0.10. Overall survial time was calculated from time of histological diagnosis until time of death from any event.||1.12|0.65|0.10
73989377|NCT03024996|147525112|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.495|TWO_SIDED|95.0|0.75|1.15|||Log Rank|||||1.15|0.75|0.4950
73989378|NCT03024996|147525113|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8868||95.0|0.67|1.42|||Log Rank|||||1.42|0.67|0.8868
73989379|NCT03024996|147525114|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.201|TWO_SIDED|95.0|0.63|1.1|||Log Rank|||||1.10|0.63|0.2010
73989380|NCT03024996|147525115|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.2811|TWO_SIDED|95.0|0.69|1.12|||Log Rank|||||1.12|0.69|0.2811
73989381|NCT03024996|147525116|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0735|TWO_SIDED|95.0|0.55|1.03|||Log Rank|||||1.03|0.55|0.0735
73989382|NCT03024996|147525117|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1396|TWO_SIDED|95.0|0.67|1.06|||Log Rank|||||1.06|0.67|0.1396
73989383|NCT03024996|147525118|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4762|TWO_SIDED|95.0|0.55|1.33|||Log Rank|||||1.33|0.55|0.4762
73989384|NCT03024996|147525119|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.5111|TWO_SIDED|95.0|0.74|1.16|||Log Rank|||||1.16|0.74|0.5111
73989385|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-3.9|5.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||5.6|-3.9|
73989386|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|3.3||||||95.0|-7.3|13.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||13.8|-7.3|
73989387|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|2.3||||||95.0|-2.1|7.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||7.3|-2.1|
73989388|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|-1.6||||||95.0|-8.2|4.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||4.7|-8.2|
74089920|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|3.71||||0.17|TWO_SIDED|95.0|-1.59|9.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Sport/Rec.||9|-1.59|0.17
74089921|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|6.01||||0.04|TWO_SIDED|95.0|0.29|11.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Sport/Rec.||11.74|0.29|0.04
73989389|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|3.0||||||95.0|-2.8|9.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.2|-2.8|
73989390|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-3.5|5.1||||||For serotype 19F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||5.1|-3.5|
73989391|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|1.1||||||95.0|-8.4|10.6||||||For serotype 23F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||10.6|-8.4|
73989392|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|2.1||||||95.0|-4.8|9.2||||||For serotype 1 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.2|-4.8|
73989393|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|-1.7||||||95.0|-7.9|4.2||||||For serotype 3 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||4.2|-7.9|
73989394|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|2.1||||||95.0|-5.6|9.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.9|-5.6|
73989395|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-9.9|7.6||||||For serotype 6A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||7.6|-9.9|
73989396|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.0|2.8||||||For serotype 7F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||2.8|-3.0|
73989397|NCT00464945|147525147|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.6|3.5||||||For serotype 19A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||3.5|-3.6|
73989398|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|1.35||||||95.0|1.1|1.65||||||For serotype 4 the GMC ratio was calculated||1.65|1.10|
73989399|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.7|1.31||||||For serotype 6B the GMC ratio was calculated||1.31|0.70|
73989400|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|1.05||||||95.0|0.89|1.24||||||For serotype 9V the GMC ratio was calculated||1.24|0.89|
73989401|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.71|1.22||||||For serotype 14 the GMC ratio was calculated||1.22|0.71|
73989402|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|1.06||||||95.0|0.86|1.3||||||For serotype 18C the GMC ratio was calculated||1.30|0.86|
73989403|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|0.98||||||95.0|0.81|1.17||||||For serotype 19F the GMC ratio was calculated||1.17|0.81|
73989404|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|0.9||||||95.0|0.7|1.15||||||For serotype 23F the GMC ratio was calculated||1.15|0.70|
73989405|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|1.1||||||95.0|0.88|1.37||||||For serotype 1 the GMC ratio was calculated||1.37|0.88|
73989406|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|1.0||||||95.0|0.83|1.2||||||For serotype 3 the GMC ratio was calculated||1.20|0.83|
73989407|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.79|1.16||||||For serotype 5 the GMC ratio was calculated||1.16|0.79|
73989408|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|0.83||||||95.0|0.66|1.05||||||For serotype 6A the GMC ratio was calculated||1.05|0.66|
73989409|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.79|1.11||||||For serotype 7F the GMC ratio was calculated||1.11|0.79|
73989410|NCT00464945|147525151|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.79|1.13||||||For serotype 19A the GMC ratio was calculated||1.13|0.79|
73989411|NCT03831854|147525152|SUPERIORITY||Median Difference (Final Values)|0.0||||0.08|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.08
73989412|NCT03831854|147525153|SUPERIORITY|||||||0.11|||||||Fisher Exact|The relative risk could not be assessed due to zero incidence in the treatment group||||||0.11
73989413|NCT03831854|147525154|SUPERIORITY||Median Difference (Final Values)|-2.3||||0.63|TWO_SIDED|98.5|-9.5|5.0|||Wilcoxon (Mann-Whitney)|||||5.0|-9.5|0.63
73989414|NCT03831854|147525155|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.58|TWO_SIDED|98.3|-1.7|2.6|||t-test, 2 sided|||||2.6|-1.7|0.58
73989415|NCT03831854|147525156|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|98.3|0.3|3.8|||Chi-squared|||||3.8|0.3|1.0
73989416|NCT03491215|147525192|OTHER|Comparison|GMR|0.801|||||TWO_SIDED|90.0|0.49|1.311||||||Group 3 vs Group 2||1.311|0.490|
73989417|NCT03491215|147525192|OTHER|Comparison|GMR|0.991|||||TWO_SIDED|90.0|0.532|1.846||||||Group 3 vs. Group 1||1.846|0.532|
73989418|NCT03491215|147525192|OTHER|Comparison|GMR|1.237|||||TWO_SIDED|90.0|0.639|2.394||||||Group 2 vs. Group 1||2.394|0.639|
73989419|NCT03491215|147525193|OTHER|Comparison|GMR|0.709|||||TWO_SIDED|90.0|0.425|1.184||||||Group 3 vs. Group 2||1.184|0.425|
73989420|NCT03491215|147525193|OTHER|Comparison|GMR|0.968|||||TWO_SIDED|90.0|0.506|1.851||||||Group 3 vs. Group 1||1.851|0.506|
73989421|NCT03491215|147525193|OTHER|Comparison|GMR|1.365|||||TWO_SIDED|90.0|0.686|2.714||||||Group 2 vs. Group 1||2.714|0.686|
73989422|NCT03491215|147525195|OTHER|Comparison|GMR|0.759|||||TWO_SIDED|90.0|0.245|2.352||||||Group 3 vs. Group 2||2.352|0.245|
73989423|NCT03491215|147525195|OTHER|Comparison|GMR|0.516|||||TWO_SIDED|90.0|0.15|1.784||||||Group 3 vs. Group 1||1.784|0.150|
73989424|NCT03491215|147525195|OTHER|Comparison|GMR|0.681|||||TWO_SIDED|90.0|0.178|2.597||||||Group 2 vs. Group 1||2.597|0.178|
73989425|NCT03491215|147525203|SUPERIORITY||Odds Ratio (OR)|0.976|||||TWO_SIDED|95.0|0.858|1.109||||||||1.109|0.858|
73989426|NCT03491215|147525203|SUPERIORITY||Odds Ratio (OR)|0.951|||||TWO_SIDED|95.0|0.735|1.232||||||||1.232|0.735|
74089922|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|3.91||||0.14|TWO_SIDED|95.0|-1.28|9.1|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS Sport/Rec.||9.1|-1.28|0.14
74089923|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|5.47||||0.05|TWO_SIDED|95.0|-0.1|11.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS Sport/Rec.||11.03|-0.1|0.05
73875793|NCT02723773|147293531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|74.75|||||TWO_SIDED|95.0|-155.17|99.49|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||99.49|-155.17|
73875794|NCT02723773|147293531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.24|||||TWO_SIDED|95.0|73.29|94.72|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||94.72|73.29|
73875795|NCT02723773|147293531|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.08|||||TWO_SIDED|95.0|73.87|95.41|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||95.41|73.87|
73875796|NCT02723773|147293532|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.67|||||TWO_SIDED|95.0|43.68|99.81|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=50 YOA Group over Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control \>=50 YOA Group and Historical Control \>=50 YOA Group.||99.81|43.68|
73875797|NCT02723773|147293532|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|-247.21|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control 60-69YOA Group over Historical Control 60-69YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||100.00|-247.21|
73875798|NCT02723773|147293532|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.91|||||TWO_SIDED|95.0|37.45|99.79|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=60YOA Group over Historical Control \>=60YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ related complications between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||99.79|37.45|
73875799|NCT02723773|147293532|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.89|||||TWO_SIDED|95.0|19.81|99.75|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=70YOA Group over Historical Control \>=70YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||99.75|19.81|
73989427|NCT03491215|147525204|SUPERIORITY||Hazard Ratio (HR)|1.014|||||TWO_SIDED|95.0|0.921|1.115||||||||1.115|0.921|
73989428|NCT03491215|147525204|SUPERIORITY||Hazard Ratio (HR)|1.029|||||TWO_SIDED|95.0|0.841|1.258||||||||1.258|0.841|
73875800|NCT02723773|147293533|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.83|||||TWO_SIDED|95.0|71.57|99.17|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group.||99.17|71.57|
74039675|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1863|TWO_SIDED|95.0|0.9|1.72|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.72|0.90|0.1863
73989429|NCT03491215|147525205|SUPERIORITY||Hazard Ratio (HR)|1.063|||||TWO_SIDED|95.0|1.012|1.117||||||||1.117|1.012|
73989430|NCT03491215|147525205|SUPERIORITY||Hazard Ratio (HR)|1.132|||||TWO_SIDED|95.0|1.025|1.25||||||||1.25|1.025|
73989431|NCT01006616|147525241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.031||||0.325|TWO_SIDED|95.0|-0.03|0.091|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and inhaled corticosteroid (ICS) use (yes/no)||||0.091|-0.030|0.325
73989432|NCT01006616|147525241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.029||||0.37|TWO_SIDED|95.0|-0.091|0.034|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)||||0.034|-0.091|0.370
73989433|NCT01006616|147525241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.037|TWO_SIDED|95.0|0.004|0.131|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)||||0.131|0.004|0.037
73989434|NCT01006616|147525242|SUPERIORITY_OR_OTHER||Difference in percentages|2.6||||0.096|TWO_SIDED|95.0|-0.6|6.9|||Miettinen and Nurminen||Analysis of Week 26 data|||6.9|-0.6|0.096
73989435|NCT01006616|147525242|SUPERIORITY_OR_OTHER||Difference in percentages|12.2|||<|0.001|TWO_SIDED|95.0|7.4|18.4|||Miettinen and Nurminen||Analysis of Week 26 data|||18.4|7.4|<0.001
73989436|NCT01006616|147525242|SUPERIORITY_OR_OTHER||Difference in percentages|19.7|||<|0.001|TWO_SIDED|95.0|13.8|26.9|||Miettinen and Nurminen||Analysis of Week 26 data|||26.9|13.8|<0.001
73989437|NCT01163955|147525276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|1.92|<|0.0005|TWO_SIDED|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in the floor.||9|0|<.0005
73989438|NCT01163955|147525276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|1.99|<|0.0005|TWO_SIDED|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in a chair.||9|0|<.0005
73989439|NCT01898442|147525285|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||ANCOVA|||||||0.017
73989440|NCT05178979|147525291|SUPERIORITY||Wald Chi-Square|1.94||||0.38|TWO_SIDED|||||Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.38
74089924|NCT02312713|147732643|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.86|TWO_SIDED|95.0|-3.29|3.96|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS QOL.||3.96|-3.29|.86
73989441|NCT05178979|147525291|SUPERIORITY||unstandardized beta|0.93|STANDARD_ERROR_OF_MEAN|4.63||0.84|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points.||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.84
73989442|NCT05178979|147525291|SUPERIORITY||unstandardized beta|-2.62|STANDARD_ERROR_OF_MEAN|3.87||0.5|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points.||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.50
73989443|NCT05178979|147525292|SUPERIORITY||Wald Chi-square|2.0||||0.37|TWO_SIDED|||||Models control for clinic and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.37
73989444|NCT05178979|147525292|SUPERIORITY||unstandardized beta|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.18|TWO_SIDED|||||P-value is adjusted for clinic; this value is the 6-month follow-up|Regression, Linear|Model controls for clinic||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.18
73989445|NCT05178979|147525292|SUPERIORITY||unstandardized beta|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.19|TWO_SIDED|||||P-value is adjusted for clinic; this value is the 12-month follow-up|Regression, Linear|Model controls for clinic|Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.19
73989446|NCT05178979|147525293|SUPERIORITY||Wald Chi-square|10.84||||0.004|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.004
73989447|NCT05178979|147525293|SUPERIORITY||unstandardized beta|0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||<0.001
74035054|NCT00755846|147622422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.1|STANDARD_ERROR_OF_MEAN|21.06||0.274||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.274
74035055|NCT00755846|147622422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|21.06||0.554||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.554
74035056|NCT02429258|147622429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.0|STANDARD_ERROR_OF_MEAN|6.08|<|0.001||95.0|-36.1|-12.0|||Mixed Models Analysis|||||-12.0|-36.1|<0.001
74035057|NCT02429258|147622430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|5.8||0.01||95.0|-26.8|-3.8|||ANCOVA|||||-3.8|-26.8|0.010
74035058|NCT02429258|147622431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.42||0.023||95.0|0.1|1.8|||ANCOVA|||||1.8|0.1|0.023
74035059|NCT02429258|147622432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_ERROR_OF_MEAN|3.65|<|0.001||95.0|7.7|22.2|||ANCOVA|||||22.2|7.7|<0.001
74035060|NCT02429258|147622433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|3.72|<|0.001||95.0|-23.5|-8.7|||ANCOVA|||||-8.7|-23.5|<0.001
73875801|NCT02723773|147293533|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|-1830.98|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of HZ/su 50-59YOA Group over Placebo/Historical Control 50-59YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||100.00|-1830.98|
73875802|NCT02723773|147293533|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|17.55|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of HZ/su 60-69YOA Group over Placebo/Historical Control 60-69YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||100.00|17.55|
73875803|NCT02723773|147293533|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.28|||||TWO_SIDED|95.0|69.17|99.11|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||99.11|69.17|
73875804|NCT02723773|147293533|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.45|||||TWO_SIDED|95.0|60.93|98.91|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||98.91|60.93|
73875805|NCT00790192|147293610|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
73875806|NCT00790192|147293611|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
73875807|NCT00411749|147293647|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73875808|NCT00411749|147293648|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73989448|NCT05178979|147525293|SUPERIORITY||unstandardized beta|-0.02|STANDARD_ERROR_OF_MEAN|0.09||0.86|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.86
73875809|NCT00411749|147293649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
74035061|NCT02429258|147622434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7|STANDARD_ERROR_OF_MEAN|8.47|<|0.001||95.0|-46.6|-12.9|||ANCOVA|||||-12.9|-46.6|<0.001
74035062|NCT02429258|147622435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|9.14|<|0.001||95.0|-59.0|-22.7|||ANCOVA|||||-22.7|-59.0|<0.001
73875810|NCT00411749|147293650|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73875811|NCT00411749|147293651|SUPERIORITY_OR_OTHER||Geometric Mean|155.2|||||TWO_SIDED|95.0|126.2|190.9||||||||190.9|126.2|
73875812|NCT00411749|147293651|SUPERIORITY_OR_OTHER||Geometric Mean|198.2|||||TWO_SIDED|95.0|160.9|244.2||||||||244.2|160.9|
73875813|NCT00411749|147293651|SUPERIORITY_OR_OTHER||Geometric Mean|617.1|||||TWO_SIDED|95.0|491.7|774.5||||||||774.5|491.7|
73875814|NCT00411749|147293651|SUPERIORITY_OR_OTHER||Geometric Mean|90.0|||||TWO_SIDED|95.0|68.8|117.8||||||||117.8|68.8|
73875815|NCT00964496|147293656|SUPERIORITY_OR_OTHER||Differences in proportions|0.677||||1.3e-07|TWO_SIDED|95.0|0.547|0.807||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||0.807|0.547|0.00000013
73875816|NCT00964496|147293657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08|||<|0.001|TWO_SIDED|95.0|-4.02|-2.13||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Comparisons were performed with the use of the independent-samples t test."||-2.13|-4.02|<0.001
73989449|NCT05178979|147525294|SUPERIORITY||Wald Chi-square|21.42|||<|0.001|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Logistic||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
73989450|NCT05178979|147525294|SUPERIORITY||unstandardized beta|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.81|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||update||||0.81
74035063|NCT02429258|147622436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.1||0.024||95.0|-0.43|-0.03|||ANCOVA|||||-0.03|-0.43|0.024
74035064|NCT02429258|147622437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|4.55||0.019||95.0|-19.9|-1.8|||ANCOVA|||||-1.8|-19.9|0.019
74035065|NCT02429258|147622438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.3|STANDARD_ERROR_OF_MEAN|9.25|<|0.001||95.0|-54.7|-17.9|||ANCOVA|||||-17.9|-54.7|<0.001
73989451|NCT05178979|147525294|SUPERIORITY||unstandardized beta|-0.22|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||update||||<0.001
73989452|NCT05178979|147525295|SUPERIORITY||Wald Chi-square|150.43|||<|0.001|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
73989453|NCT05178979|147525295|SUPERIORITY||unstandardized beta|0.17|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|||||||0.002
73989454|NCT05178979|147525295|SUPERIORITY||unstandardized beta|0.13|STANDARD_ERROR_OF_MEAN|0.06||0.03|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|||||||0.03
73989455|NCT05178979|147525296|SUPERIORITY||Wald Chi-square|8.72||||0.01|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.01
73989456|NCT05178979|147525296|SUPERIORITY||unstandardized beta|0.42|STANDARD_ERROR_OF_MEAN|0.29||0.15|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.15
73989457|NCT05178979|147525296|SUPERIORITY||unstandardized beta|0.32|STANDARD_ERROR_OF_MEAN|0.12||0.008|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.008
73989458|NCT05178979|147525297|SUPERIORITY||Wald Chi-square|172.52|||<|0.001|TWO_SIDED|||||Models control for clinic and income and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
73989459|NCT05178979|147525297|SUPERIORITY||unstandardized beta|0.14|STANDARD_ERROR_OF_MEAN|0.34||0.68|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 6-month follow-up|Regression, Linear|Models control for clinic and income and are adjusted for multiple time points.||||||0.68
73989460|NCT05178979|147525297|SUPERIORITY||unstandardized beta|-0.83|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic and income and are adjusted for multiple time points.||||||<0.001
73989461|NCT05178979|147525298|SUPERIORITY|Models control for clinic, income, years living with HIV and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Wald Chi-square|25.27|||<|0.001|TWO_SIDED||||||Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
74035066|NCT02429258|147622439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|2.86||0.017||95.0|1.3|12.7|||ANCOVA|||||12.7|1.3|0.017
73989462|NCT05178979|147525298|SUPERIORITY||unstandardized beta|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.1|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 6-month follow-up.|Regression, Linear|Models control for clinic, income, years living with HIV and are adjusted for multiple time points.||||||0.10
73989463|NCT05178979|147525298|SUPERIORITY||unstandardized beta|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.54|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 12-month follow-up.|Regression, Linear|Models control for clinic, income, years living with HIV and are adjusted for multiple time points||||||0.54
73989464|NCT05178979|147525299|SUPERIORITY|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Wald Chi-square|36.04|||<|0.001|TWO_SIDED|||||Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
73989465|NCT05178979|147525299|SUPERIORITY||unstandardized beta|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.97|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.||||||0.97
73989466|NCT05178979|147525299|SUPERIORITY||unstandardized beta|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.||||||<0.001
73989467|NCT05178979|147525300|SUPERIORITY||Wald Chi-square|9.46||||0.01|TWO_SIDED|||||Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.01
73989468|NCT05178979|147525300|SUPERIORITY||unstandardized beta|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.81|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points.||||||0.81
73989469|NCT05178979|147525300|SUPERIORITY||unstandardized beta|-0.25|STANDARD_ERROR_OF_MEAN|0.13||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points.||||||0.04
73989470|NCT05178979|147525301|SUPERIORITY||Wald Chi-square|14.77|||<|0.001|TWO_SIDED|||||Models control for clinic, gender, years living with HIV and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
74039676|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0667|TWO_SIDED|95.0|0.98|1.86|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|0.98|0.0667
73875817|NCT00964496|147293658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.95|||<|0.01|TWO_SIDED|95.0|6.0|9.9||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Comparisons were performed with the use of the independent-samples t test."||9.90|6.00|<0.01
73875818|NCT00964496|147293659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.0002474|TWO_SIDED|95.0|2.15|6.64||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Comparisons were performed with the use of the independent-samples t test."||6.64|2.15|0.00024740
73875819|NCT00964496|147293660|SUPERIORITY_OR_OTHER||Differences in proportions|-0.374||||0.00298881|TWO_SIDED|95.0|-0.563|-0.185||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||-0.185|-0.563|0.00298881
73875820|NCT00964496|147293661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1557.14|||<|0.01|TWO_SIDED|95.0|1294.53|1819.76||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Comparisons were performed with the use of the independent-samples t test."||1819.76|1294.53|<0.01
73875821|NCT00964496|147293662|SUPERIORITY_OR_OTHER||Differences in proportions|0.464||||3.962e-05|TWO_SIDED|95.0|0.28|0.649|||Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the cessation of bleeding.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the cessation of bleeding.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||0.649|0.28|0.00003962
73875822|NCT01147666|147293663|OTHER|||||||1||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||1.0000
73875823|NCT01147666|147293663|OTHER|||||||0.0698||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.0698
73989471|NCT05178979|147525301|SUPERIORITY||unstandardized beta|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.45|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV and are adjusted for multiple time points.||||||0.45
73989472|NCT05178979|147525301|SUPERIORITY||unstandardized beta|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.02|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV and are adjusted for multiple time points.||||||0.02
73875824|NCT01147666|147293663|OTHER|||||||0.1534||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.1534
73989473|NCT05178979|147525302|SUPERIORITY||Wald Chi-square|11.06||||0.004|TWO_SIDED|||||Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.004
73989474|NCT05178979|147525302|SUPERIORITY||unstandardized beta|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.35|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points.||||||0.35
73875825|NCT01147666|147293663|OTHER|||||||0.2657||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.2657
73875826|NCT01147666|147293664|OTHER|||||||1||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||1.0000
73989475|NCT05178979|147525302|SUPERIORITY||unstandardized beta|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points.||||||0.04
73989476|NCT05178979|147525303|SUPERIORITY||Wald Chi-square|2.84||||0.24|TWO_SIDED|||||Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.24
73989477|NCT05178979|147525303|SUPERIORITY||unstandardized beta|0.02|STANDARD_ERROR_OF_MEAN|0.17||0.92|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points.||||||0.92
73875827|NCT01721161|147293778|SUPERIORITY_OR_OTHER||Difference|-3.48||||0.3337|TWO_SIDED|95.0|-10.61|3.65|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||3.65|-10.61|0.3337
73875828|NCT01721161|147293779|SUPERIORITY_OR_OTHER||Difference|-3.89||||0.1868|TWO_SIDED|95.0|-9.7|1.92|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||1.92|-9.70|0.1868
73875829|NCT01721161|147293780|SUPERIORITY_OR_OTHER||Difference|-4.76||||0.1488|TWO_SIDED|95.0|-11.26|1.74|||ANCOVA|||||1.74|-11.26|0.1488
73875830|NCT01721161|147293781|SUPERIORITY_OR_OTHER||Difference|-1.15||||0.4975|TWO_SIDED|95.0|-4.51|2.21|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||2.21|-4.51|0.4975
73875831|NCT01721161|147293782|SUPERIORITY_OR_OTHER||Difference|-1.76||||0.3505|TWO_SIDED|95.0|-5.5|1.98|||ANCOVA|||||1.98|-5.50|0.3505
74035067|NCT02397694|147622440|NON_INFERIORITY|Noninferiority of treatment with BIC + F/TAF relative to treatment with DTG + F/TAF. Noninferiority assessed using a conventional 95% confidence interval (CI) approach, with a noninferiority margin of 12%|Difference in percentages|2.9||||0.5|TWO_SIDED|95.0|-8.5|14.2|||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline HIV-1 RNA stratum (≤ 100,000 copies/mL vs \> 100,000 copies/mL).||||14.2|-8.5|0.5
74035068|NCT00078559|147622456|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.1|||||TWO_SIDED|95.0|0.01|0.34|||95% Confidence Interval|Exact Binomial||||0.34|0.01|
74035069|NCT00078559|147622457|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial||||0.3|0.0|
74035070|NCT00078559|147622458|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.0|||||TWO_SIDED|95.0|0.0|0.7|||95% Confidence Interval|Exact Binomial||||0.7|0.0|
74035071|NCT00078559|147622461|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial||||0.3|0.0|
74035072|NCT00078559|147622462|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial for all participants (n=10)||||0.3|0.0|
74035073|NCT00078559|147622463|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.4|||95% Confidence Interval|Exact Binomial for Not Withdrawn Group||||0.4|0.0|
74035074|NCT00078559|147622463|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.8|||95% Confidence Interval|Exact Binomial for Withdrawn Group||||0.8|0.0|
74035075|NCT00078559|147622464|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.4|||95% Confidence Interval|Exact Binomial for Not Withdrawn Group||||0.4|0.0|
74035076|NCT00078559|147622464|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.8|||95% Confidence Interval|Exact Binomial for Withdrawn Group||||0.8|0.0|
74035077|NCT01694420|147622473|SUPERIORITY_OR_OTHER||||||<|0.001||||||Study data compared to data as cited in PubMed ID: 21487250|Wilcoxon (Mann-Whitney)|||||||<0.001
74035078|NCT02670915|147622485|NON_INFERIORITY|Stepwise hierarchical testing procedure was applied: Step 1-Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% confidence interval (CI) was below or equal to 0.4%.|Treatment difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.3|-0.03||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The primary analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value (s) imputed from the available information from the treatment the participant had been randomised to.||-0.03|-0.30|<0.001
74035079|NCT02670915|147622485|NON_INFERIORITY|Stepwise hierarchical testing procedure was applied: Step 2-Confirmatory secondary analysis: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%.|Treatment difference|0.13|||<|0.001|TWO_SIDED|95.0|-0.01|0.26||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.||0.26|-0.01|<0.001
74035080|NCT02670915|147622485|SUPERIORITY|Stepwise hierarchical testing procedure was applied: Step 3-Confirmatory secondary analysis: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Superiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below 0.|Treatment difference|-0.17|||=|0.007|TWO_SIDED|95.0|-0.3|-0.03||p-values are from the 1-sided test for superiority evaluated at the 2.5% level.|multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.||-0.03|-0.30|=0.007
74035081|NCT03725202|147622565|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|17.1|||=|0.0019|TWO_SIDED|95.0|6.3|27.8|||Cochran-Mantel-Haenszel||Response rate difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||27.8|6.3|=0.0019
74035082|NCT03725202|147622565|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|12.1|||=|0.0579|TWO_SIDED|95.0|-0.4|24.6|||Cochran-Mantel-Haenszel||Response rate difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||24.6|-0.4|=0.0579
74035083|NCT03725202|147622566|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|20.7|||<|0.0001|TWO_SIDED|95.0|11.3|30.2|||Cochran-Mantel-Haenszel||Response rate difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||30.2|11.3|<0.0001
73875832|NCT01721161|147293783|SUPERIORITY_OR_OTHER||Difference|-1.6||||0.5371|TWO_SIDED|95.0|-6.9|3.6|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 1.25% chart||3.6|-6.9|0.5371
73875833|NCT01721161|147293783|SUPERIORITY_OR_OTHER||Difference|-0.8||||0.7741|TWO_SIDED|95.0|-6.5|4.9|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 2.5% chart||4.9|-6.5|0.7741
73875834|NCT01721161|147293784|SUPERIORITY_OR_OTHER||Difference|-1.2||||0.6645|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|||LCLA 1.25% chart||4.3|-6.6|0.6645
73875835|NCT01721161|147293784|SUPERIORITY_OR_OTHER||DIfference|-0.8||||0.8015|TWO_SIDED|95.0|-6.7|5.2|||ANCOVA|||LCLA 2.5%||5.2|-6.7|0.8015
73875836|NCT01721161|147293785|SUPERIORITY_OR_OTHER||Difference|-7.55||||0.0504|TWO_SIDED|95.0|-15.12|0.01|||ANCOVA|||||0.01|-15.12|0.0504
73875837|NCT02673918|147293802|EQUIVALENCE|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73875838|NCT02673918|147293803|EQUIVALENCE|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73875839|NCT02927392|147293808|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
73875840|NCT01708317|147293814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||<|0.001||||||We used a cutoff of P\<0.05 as statistically significant.|Chi-squared|3 degrees of freedom to compare 4 time periods.||We compared testing in the 4 time frames described, including the time frame in which we enrolled patients in the ACASI.||||<.001
73875841|NCT03259555|147293821|SUPERIORITY||Treatment difference|0.14|||=|0.8797|TWO_SIDED|95.0|-1.74|2.03|||Mixed-effect Model Repeated Measure|"An unstructured covariance was used."|"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."|||2.03|-1.74|=0.8797
73875842|NCT04532034|147293823|OTHER||Mean Difference (Final Values)|0.067||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||.95
73875843|NCT04970654|147293858|NON_INFERIORITY|Non-inferiority was considered confirmed if the lower bound of the 95% confidence interval was higher than the margin of -2.0 cm/year.|Treatment difference|0.6|||||TWO_SIDED|95.0|-0.2|1.3||||||Hypothetical strategy estimand. Height velocity at 52 weeks was analyzed using a mixed model for repeated measurements, with treatment, gender, age group, growth hormone (GH) peak group and gender by age group interaction term as factors and baseline height as a covariate, all nested within week as a factor.||1.3|-0.2|
73875844|NCT06172348|147293868|OTHER||Ratio of Adjusted Geometric Means|21.89|||||TWO_SIDED|90.0|19.31|24.8|||||Ratios (Test/Reference) and 90 percent (%) confidence intervals were expressed as percentages. Test = MR1 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||24.80|19.31|
73875845|NCT06172348|147293868|OTHER||Ratio of Adjusted Geometric Means|12.65|||||TWO_SIDED|90.0|11.21|14.27|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||14.27|11.21|
73875846|NCT06172348|147293869|OTHER||Ratio of Adjusted Geometric Means|86.49|||||TWO_SIDED|90.0|79.11|94.54|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||94.54|79.11|
74089925|NCT02312713|147732643|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.59||||0.15|TWO_SIDED|95.0|-0.96|6.13|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS QOL.||6.13|-0.96|0.15
73875847|NCT06172348|147293869|OTHER||Ratio of Adjusted Geometric Means|76.99|||||TWO_SIDED|90.0|70.65|83.9|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||83.90|70.65|
73989478|NCT05178979|147525303|SUPERIORITY||unstandardized beta|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.21|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points.||||||0.21
73875848|NCT06172348|147293870|OTHER||Ratio of Adjusted Geometric Means|123.92|||||TWO_SIDED|90.0|105.16|146.02|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule (fed); Reference = MR1 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||146.02|105.16|
73875849|NCT06172348|147293870|OTHER||Ratio of Adjusted Geometric Means|129.79|||||TWO_SIDED|90.0|111.51|151.06|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||151.06|111.51|
73989479|NCT03124550|147525304|OTHER|||||||0.0008|||||||Multilevel Modeling|||Multilevel modeling with the LMER package in R was used to determine whether participants changed in weekly average steps over the 6-week intervention.||||.0008
74089926|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|3.63||||0.11|TWO_SIDED|95.0|-0.85|8.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS QOL.||8.11|-0.85|0.11
73875850|NCT06172348|147293871|OTHER||Ratio of Adjusted Geometric Means|107.48|||||TWO_SIDED|90.0|96.46|119.76|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule (fed); Reference = MR1 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||119.76|96.46|
73989480|NCT03124550|147525305|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Pre-test and post-test comparison||||.01
74089927|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|7.74||||0|TWO_SIDED|95.0|3.39|12.08|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS QOL.||12.08|3.39|0
73989481|NCT03124550|147525306|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Pre-test and post-test comparison||||.94
73989482|NCT03124550|147525307|OTHER|||||||0.0007|||||||Multilevel Modeling|||Multilevel modeling with the LMER package in R was used to determine whether participants changed in weekly number of social contact over the 6-week intervention.||||.0007
73989483|NCT03398421|147525347|SUPERIORITY||Ratio of adjusted geometric mean|2.005|||||TWO_SIDED|90.0|1.807|2.224||||||||2.224|1.807|
73989484|NCT03398421|147525354|SUPERIORITY||Ratio of adjusted geometric mean|0.802|||||TWO_SIDED|90.0|0.69|0.933||||||||0.933|0.690|
73989485|NCT03269695|147525409|SUPERIORITY||Treatment difference|1.8||||1|TWO_SIDED|95.0|-41.0|47.2|||Chan and Zhang (1999)|||||47.2|-41.0|1.0000
73989486|NCT03269695|147525410|SUPERIORITY||Treatment difference|0.0||||1|TWO_SIDED|95.0|-37.0|37.0|||Chan and Zhang (1999)|||||37.0|-37.0|1.0000
73989487|NCT03269695|147525411|SUPERIORITY||Treatment difference|14.3||||0.47|TWO_SIDED|95.0|-23.8|57.9|||Chan and Zhang (1999)|||||57.9|-23.8|0.4700
73989488|NCT03269695|147525412|SUPERIORITY||Treatment difference|10.0||||0.5221|TWO_SIDED|95.0|-20.7|45.6|||Chan and Zhang (1999)|||||45.6|-20.7|0.5221
73989489|NCT03269695|147525413|SUPERIORITY||Treatment difference|32.1||||0.3166|TWO_SIDED|95.0|-23.7|74.1|||Chan and Zhang (1999)|||||74.1|-23.7|0.3166
73989490|NCT03269695|147525414|SUPERIORITY||Treatment difference|20.0||||0.5234|TWO_SIDED|95.0|-22.9|58.5|||Chan and Zhang (1999)|||||58.5|-22.9|0.5234
73989491|NCT03269695|147525415|SUPERIORITY||Treatment difference|-25.0||||0.7393|TWO_SIDED|95.0|-69.6|29.1|||Chan and Zhang (1999)|||||29.1|-69.6|0.7393
73989492|NCT03269695|147525416|SUPERIORITY||Least squares mean difference|5.8||||0.2705|TWO_SIDED|95.0|-5.08|16.67|||ANCOVA|||||16.67|-5.08|0.2705
73989493|NCT03269695|147525417|SUPERIORITY||Treatment difference|48.2||||0.0732|TWO_SIDED|95.0|-4.4|84.7|||Chan and Zhang (1999)|||||84.7|-4.4|0.0732
73989494|NCT03269695|147525418|SUPERIORITY||Treatment difference|30.0||||0.2633|TWO_SIDED|95.0|-18.4|69.2|||Chan and Zhang (1999)|||||69.2|-18.4|0.2633
73875851|NCT06172348|147293871|OTHER||Ratio of Adjusted Geometric Means|109.63|||||TWO_SIDED|90.0|99.19|121.17|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||121.17|99.19|
73989495|NCT03269695|147525419|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.15|6.54|||Generalized Linear Mixed Model|||At Week 2||6.54|0.15|1.0000
73989496|NCT03269695|147525419|SUPERIORITY||Odds Ratio (OR)|1.5||||0.6691|TWO_SIDED|95.0|0.23|10.0|||Generalized Linear Mixed Model|||At Week 4||10.00|0.23|0.6691
73989497|NCT03269695|147525419|SUPERIORITY||Odds Ratio (OR)|0.62||||0.6248|TWO_SIDED|95.0|0.09|4.4|||Generalized Linear Mixed Model|||At Week 8||4.40|0.09|0.6248
73989498|NCT03269695|147525419|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9965|TWO_SIDED|95.0|0.12|8.3|||Generalized Linear Mixed Model|||At Week 12||8.30|0.12|0.9965
73989499|NCT01313624|147525446|SUPERIORITY_OR_OTHER||Difference in least squares mean|0.8||||0.68|TWO_SIDED|95.0|-3.1|4.7||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||4.7|-3.1|0.68
73989500|NCT01313624|147525447|SUPERIORITY_OR_OTHER||Difference in least squares mean|1.3||||0.56|TWO_SIDED|95.0|-3.0|5.6||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||5.6|-3.0|0.56
73989501|NCT00846768|147525451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.015||0.3011||95.0|-0.014|0.044|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.044|-0.014|0.3011
73989502|NCT00846768|147525451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.015||0.1582||95.0|-0.008|0.05|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.050|-0.008|0.1582
73989503|NCT00846768|147525451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.015||0.0003||95.0|0.025|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.083|0.025|0.0003
73989504|NCT00846768|147525451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.015||0.7046||95.0|-0.034|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.023|-0.034|0.7046
73989505|NCT00846768|147525451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.015||0.0248||95.0|0.004|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.063|0.004|0.0248
73989506|NCT00846768|147525452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052|STANDARD_ERROR_OF_MEAN|0.015||0.0006||95.0|-0.081|-0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.023|-0.081|0.0006
73989507|NCT00846768|147525452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047|STANDARD_ERROR_OF_MEAN|0.015||0.0019||95.0|-0.076|-0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||-0.017|-0.076|0.0019
73989508|NCT00846768|147525452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.015||0.4111||95.0|-0.041|0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.017|-0.041|0.4111
73989509|NCT00846768|147525452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.015||0.709||95.0|-0.035|0.024|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.024|-0.035|0.7090
74089928|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|3.29||||0.14|TWO_SIDED|95.0|-1.08|7.67|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS QOL.||7.67|-1.08|0.14
73875852|NCT02831764|147293879|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 was greater than -10%.|Adjusted difference in proportion|-0.7|||||TWO_SIDED|95.0|-4.3|2.9|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 copies per milliliter) and CD4+ cell count (\<= vs. \>200 cells per cubic millimeter \[cells/mm\^3\]).|||2.9|-4.3|
73875853|NCT02831764|147293880|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 24 was greater than -10%.|Adjusted difference in proportion|0.1|||||TWO_SIDED|95.0|-3.4|3.6|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||3.6|-3.4|
73875854|NCT02831764|147293881|OTHER||Adjusted difference in proportion|-1.8|||||TWO_SIDED|95.0|-6.4|2.7|||||Week 96. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||2.7|-6.4|
73875855|NCT02831764|147293882|OTHER||Adjusted difference in proportion|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||Week 144. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||5.3|-5.3|
73875856|NCT02831764|147293883|OTHER||Hazard Ratio (HR)|1.02||||0.797|TWO_SIDED|95.0|0.88|1.19||The generalised Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalised Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model.|||1.19|0.88|0.797
73875857|NCT02831764|147293887|OTHER||Mean Difference (Net)|25.6||||0.043|TWO_SIDED|95.0|0.8|50.4|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||50.4|0.8|0.043
73989510|NCT00846768|147525452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.015||0.0211||95.0|0.005|0.064|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.064|0.005|0.0211
73989511|NCT00846768|147525453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.014||0.1753||95.0|-0.045|0.008|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.008|-0.045|0.1753
74089929|NCT02312713|147732643|SUPERIORITY||Mean Difference (Final Values)|5.15||||0.02|TWO_SIDED|95.0|0.92|9.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS QOL.||9.37|0.92|0.02
73875858|NCT02831764|147293887|OTHER||Mean Difference (Net)|8.5||||0.523|TWO_SIDED|95.0|-17.7|34.8|||MMRM||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||34.8|-17.7|0.523
73875859|NCT02831764|147293888|OTHER||Mean Difference (Net)|7.4||||0.635|TWO_SIDED|95.0|-23.2|38.0|||Mixed Model Repeated Measures (MMRM)||Week 96. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||38.0|-23.2|0.635
73875860|NCT02831764|147293889|OTHER||Mean Difference (Net)|5.1||||0.777|TWO_SIDED|95.0|-29.9|40.0|||MMRM||Week 144.Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||40.0|-29.9|0.777
73989512|NCT00846768|147525453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.014||0.3444||95.0|-0.04|0.014|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.014|-0.040|0.3444
73989513|NCT00846768|147525453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.014||0.1161||95.0|-0.005|0.049|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.049|-0.005|0.1161
73989514|NCT00846768|147525453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.014||0.6789||95.0|-0.033|0.021|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.021|-0.033|0.6789
74089930|NCT02312713|147732644|SUPERIORITY||Mean Difference (Final Values)|-2.58||||0.02|TWO_SIDED|95.0|-4.67|-0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||-0.5|-4.67|0.02
73875861|NCT02831764|147293900|OTHER||Mean Difference (Net)|-0.03|||<|0.001|TWO_SIDED|95.0|-0.05|-0.02|||MMRM||Week 24. Serum Cystatin C.|||-0.02|-0.05|<0.001
73875862|NCT02831764|147293900|OTHER||Mean Difference (Net)|-0.02||||0.022|TWO_SIDED|95.0|-0.03|0.0|||MMRM||Week 48. Serum Cystatin C.|||0.00|-0.03|0.022
73875863|NCT02831764|147293900|OTHER||Mean Difference (Net)|-0.2||||0.797|TWO_SIDED|95.0|-1.4|1.1|||MMRM||Week 24. Serum RBP|||1.1|-1.4|0.797
73875864|NCT02831764|147293900|OTHER||Mean Difference (Net)|0.7||||0.258|TWO_SIDED|95.0|-0.5|1.9|||MMRM||Week 48. Serum RBP|||1.9|-0.5|0.258
73875865|NCT02831764|147293901|OTHER||Mean Difference (Net)|-0.02||||0.034|TWO_SIDED|95.0|-0.03|0.0|||MMRM||Week 96. Serum Cystatin C.|||0.00|-0.03|0.034
74089931|NCT02312713|147732644|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.33|TWO_SIDED|95.0|-3.22|1.09|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||1.09|-3.22|0.33
74089932|NCT02312713|147732644|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.72|TWO_SIDED|95.0|-2.52|1.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||1.74|-2.52|0.72
73875866|NCT02831764|147293902|OTHER||Mean Difference (Net)|-0.02||||0.006|TWO_SIDED|95.0|-0.04|-0.01|||MMRM||Week 144. Serum Cystatin C.|||-0.01|-0.04|0.006
73989515|NCT00846768|147525453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.014||0.0129||95.0|0.007|0.062|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.062|0.007|0.0129
74035084|NCT03725202|147622566|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|9.9|||=|0.0699|TWO_SIDED|95.0|-0.8|20.6|||Cochran-Mantel-Haenszel||Response rate difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||20.6|-0.8|=0.0699
73875867|NCT02831764|147293905|OTHER||Mean Difference (Net)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|5.4|||MMRM||Week 24. GFR Cystatin C adjusted.|||5.4|1.8|<0.001
73989516|NCT00846768|147525454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.017||0.4931||95.0|-0.023|0.047|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.047|-0.023|0.4931
73989517|NCT00846768|147525454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.2597||95.0|-0.015|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.054|-0.015|0.2597
73989518|NCT00846768|147525454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.018||0.0006||95.0|0.027|0.097|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.097|0.027|0.0006
73989519|NCT00846768|147525454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.017||0.6578||95.0|-0.042|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.027|-0.042|0.6578
73989520|NCT00846768|147525454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.018||0.0175||95.0|0.008|0.077|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.077|0.008|0.0175
73875868|NCT02831764|147293905|OTHER||Mean Difference (Net)|1.7||||0.056|TWO_SIDED|95.0|0.0|3.5|||MMRM||Week 48. GFR Cystatin C adjusted.|||3.5|0.0|0.056
73875869|NCT02831764|147293905|OTHER||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED|95.0|1.7|5.2|||MMRM||Week 24. GFR creatinine adjusted.|||5.2|1.7|<0.001
73989521|NCT00846768|147525455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.02||0.0353||95.0|-0.081|-0.003|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.003|-0.081|0.0353
73989522|NCT00846768|147525455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.2875||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.018|-0.060|0.2875
73989523|NCT00846768|147525455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.02||0.4553||95.0|-0.024|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.054|-0.024|0.4553
73989524|NCT00846768|147525455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.2902||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.018|-0.060|0.2902
73989525|NCT00846768|147525455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.02||0.0731||95.0|-0.003|0.075|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.075|-0.003|0.0731
73989526|NCT00846768|147525456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.027||0.0917||95.0|-0.008|0.099|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.099|-0.008|0.0917
73989527|NCT00846768|147525456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.027||0.1273||95.0|-0.012|0.095|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.095|-0.012|0.1273
73989528|NCT00846768|147525456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.027||0.008||95.0|0.019|0.127|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.127|0.019|0.0080
74035085|NCT03725202|147622567|SUPERIORITY|P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).|||||<|0.0001|||||||van Elteren test|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||||<0.0001
73875870|NCT02831764|147293905|OTHER||Mean Difference (Net)|3.3|||<|0.001|TWO_SIDED|95.0|1.6|5.0|||MMRM||Week 48. GFR creatinine adjusted.|||5.0|1.6|<0.001
73875871|NCT02831764|147293908|OTHER||Mean Difference (Net)|-3.02|||<|0.001|TWO_SIDED|95.0|-4.49|-1.55|||MMRM||Week 24. Serum or Plasma Creatinine|||-1.55|-4.49|<0.001
73875872|NCT02831764|147293908|OTHER||Mean Difference (Net)|-3.12|||<|0.001|TWO_SIDED|95.0|-4.59|-1.65|||MMRM||Week 48. Serum or Plasma creatinine|||-1.65|-4.59|<0.001
73875873|NCT02831764|147293909|OTHER||Mean Difference (Net)|-3.04|||<|0.001|TWO_SIDED|95.0|-4.56|-1.53|||MMRM||Week 96. Serum or Plasma creatinine|||-1.53|-4.56|<0.001
73989529|NCT00846768|147525456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.027||0.8683||95.0|-0.049|0.058|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.058|-0.049|0.8683
73989530|NCT00846768|147525456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.027||0.2444||95.0|-0.022|0.086|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.086|-0.022|0.2444
73989531|NCT00846768|147525457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.032||0.0023||95.0|-0.162|-0.036|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.036|-0.162|0.0023
73989532|NCT00846768|147525457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.103|STANDARD_ERROR_OF_MEAN|0.032||0.0015||95.0|-0.165|-0.04|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||-0.040|-0.165|0.0015
73989533|NCT00846768|147525457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.032||0.4508||95.0|-0.087|0.039|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.039|-0.087|0.4508
73989534|NCT00846768|147525457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.032||0.9087||95.0|-0.059|0.066|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.066|-0.059|0.9087
73989535|NCT00846768|147525457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.032||0.0146||95.0|0.016|0.142|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.142|0.016|0.0146
73989536|NCT00846768|147525458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|STANDARD_ERROR_OF_MEAN|0.027||0.3291||95.0|-0.08|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.027|-0.080|0.3291
73989537|NCT00846768|147525458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.027||0.2638||95.0|-0.084|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.023|-0.084|0.2638
73989538|NCT00846768|147525458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.027||0.3386||95.0|-0.028|0.08|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.080|-0.028|0.3386
73989539|NCT00846768|147525458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.027||0.8877||95.0|-0.05|0.057|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.057|-0.050|0.8877
73989540|NCT00846768|147525458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.027||0.0402||95.0|0.003|0.111|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.111|0.003|0.0402
73989541|NCT00846768|147525459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.034||0.0133||95.0|0.018|0.151|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.151|0.018|0.0133
73989542|NCT00846768|147525459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.034||0.045||95.0|0.002|0.135|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.135|0.002|0.0450
73989543|NCT00846768|147525459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.034||0.0078||95.0|0.025|0.159|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.159|0.025|0.0078
73989544|NCT00846768|147525459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.034||0.6268||95.0|-0.05|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.083|-0.050|0.6268
73989545|NCT00846768|147525459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.034||0.4891||95.0|-0.044|0.091|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.091|-0.044|0.4891
73989546|NCT00846768|147525460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.04||0.6259||95.0|-0.097|0.059|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.059|-0.097|0.6259
73989547|NCT00846768|147525460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.039||0.919||95.0|-0.082|0.074|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.074|-0.082|0.9190
73875874|NCT02831764|147293910|OTHER||Mean Difference (Net)|-2.86|||<|0.001|TWO_SIDED|95.0|-4.52|-1.19|||MMRM||Week 144. Serum or Plasma creatinine|||-1.19|-4.52|<0.001
73989548|NCT00846768|147525460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.04||0.0985||95.0|-0.012|0.145|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.145|-0.012|0.0985
73989549|NCT00846768|147525460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.039||0.6991||95.0|-0.093|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.063|-0.093|0.6991
73989550|NCT00846768|147525460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0802||95.0|-0.009|0.149|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.149|-0.009|0.0802
73989551|NCT03121612|147525482|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.65||||||Threshold for superiority p\<0.05; primary outcome, so not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."||||0.65
73989552|NCT03121612|147525482|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 28-33 gestational weeks (n=41). No adjustment for multiple comparisons.||||0.64
73989553|NCT03121612|147525482|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 34-36 gestational weeks (n=10). No adjustment for multiple comparisons.||||1.0
73989554|NCT03121612|147525483|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.8||||||Threshold for superiority p\<0.05; not adjusted for multiple comparisons|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution not normal by visual examination, so non-parametric test (Wilcoxon) used."||||0.80
73989555|NCT03121612|147525484|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.86||||||Threshold for superiority p\<0.05; not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."||||0.86
74035086|NCT03725202|147622567|SUPERIORITY|P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).|||||<|0.0001|||||||van Elteren test|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||||<0.0001
74035087|NCT03725202|147622568|SUPERIORITY|Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates|Cox Proportional Hazard|0.57|||=|0.0025|TWO_SIDED|95.0|0.399|0.826|||Log-rank test|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.826|0.399|=0.0025
74039677|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0101|TWO_SIDED|95.0|1.18|3.39|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.39|1.18|0.0101
73989556|NCT03121612|147525488|SUPERIORITY|||||||1||||||Not adjusted for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.||||||1.0
73989557|NCT03121612|147525489|SUPERIORITY|||||||0.33||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational group.||||||0.33
73989558|NCT03121612|147525490|SUPERIORITY|||||||0.31||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational age-group.||||||0.31
73989559|NCT03121612|147525491|SUPERIORITY|||||||0.81||||||Not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation||||||0.81
73989560|NCT03121612|147525492|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73875875|NCT02831764|147293911|OTHER||Ratio of geometric means|0.917|||<|0.001|TWO_SIDED|95.0|0.893|0.941|||MMRM||Week 24. Serum B2M.|||0.941|0.893|<0.001
73989561|NCT03121612|147525498|SUPERIORITY|||||||1||||||No adjustment for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.||||||1.0
73989562|NCT03121612|147525500|SUPERIORITY|||||||1|||||||Fisher Exact|No adjustment for multiple comparisons||||||1.0
73989563|NCT01841112|147525517|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3712|||||TWO_SIDED|95.0|0.7272|2.0151|||||The standard error of slope estimate = 0.3038.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||2.0151|0.7272|
73989564|NCT01841112|147525517|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3652|||||TWO_SIDED|95.0|1.0421|1.6883|||||The standard error of slope estimate = 0.1516.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.6883|1.0421|
73875876|NCT02831764|147293911|OTHER||Ratio of geometric means|0.914|||<|0.001|TWO_SIDED|95.0|0.89|0.939|||MMRM||Week 48. Serum B2M.|||0.939|0.890|<0.001
73875877|NCT02831764|147293911|OTHER||Ratio of geometric means|0.748||||0.002|TWO_SIDED|95.0|0.621|0.901|||MMRM||Week 24. Urine B2M.|||0.901|0.621|0.002
73989565|NCT01841112|147525518|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.1998|||||TWO_SIDED|95.0|0.4794|1.9202|||||The standard error of slope estimate = 0.3380.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.9202|0.4794|
73989566|NCT01841112|147525518|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0299|||||TWO_SIDED|95.0|0.7131|1.3466|||||The standard error of slope estimate = 0.1486.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.3466|0.7131|
73989567|NCT01841112|147525519|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2015|||||TWO_SIDED|95.0|0.5078|1.8952|||||The standard error of slope estimate = 0.3272.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.8952|0.5078|
73989568|NCT01841112|147525519|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0301|||||TWO_SIDED|95.0|0.7133|1.3469|||||The standard error of slope estimate = 0.1486.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.3469|0.7133|
73989569|NCT03448536|147525540|SUPERIORITY||LS Means Difference|4.31|||<|0.001|TWO_SIDED|95.0|2.06|6.56|||ANCOVA|||||6.56|2.06|< 0.001
73989570|NCT03448536|147525541|SUPERIORITY||LS Means Difference|9.8|||<|0.001|TWO_SIDED|95.0|5.75|13.85|||ANCOVA|||||13.85|5.75|< 0.001
73989571|NCT03448536|147525542|SUPERIORITY||LS Means Difference|1.52|||=|0.129|TWO_SIDED|95.0|-0.45|3.49|||ANCOVA|||||3.49|-0.45|= 0.129
73989572|NCT03448536|147525543|SUPERIORITY||LS Means Difference|8.27|||<|0.001|TWO_SIDED|95.0|5.76|10.78|||ANCOVA|||||10.78|5.76|< 0.001
73989573|NCT03448536|147525544|SUPERIORITY||LS Means Difference|0.56|||=|0.307|TWO_SIDED|95.0|-0.52|1.64|||ANCOVA|||||1.64|-0.52|= 0.307
73989574|NCT03448536|147525545|SUPERIORITY||LS Means Difference|3.75|||<|0.001|TWO_SIDED|95.0|2.34|5.16|||ANCOVA|||||5.16|2.34|< 0.001
73989575|NCT03448536|147525546|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
73989576|NCT03448536|147525548|SUPERIORITY||||||=|0.002|||||||Cochran-Mantel-Haenszel|||||||= 0.002
73989577|NCT03783546|147525550|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
73989578|NCT03783546|147525552|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
73989579|NCT01024036|147525613|SUPERIORITY_OR_OTHER||difference in the response rate|34.0||||0.0012|TWO_SIDED|95.0|11.1|54.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms||54.8|11.1|0.0012
73989580|NCT01024036|147525613|SUPERIORITY_OR_OTHER||difference in the response rate|34.0||||0.0004|TWO_SIDED|95.0|11.1|54.8|||Fisher Exact|Without adjusting for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms||54.8|11.1|0.0004
73989581|NCT01024036|147525615|SUPERIORITY_OR_OTHER||Difference in overall response rates|33.9||||0.0022|TWO_SIDED|95.0|11.1|54.8|||Cochran-Mantel-Haenszel|||||54.8|11.1|0.0022
73989582|NCT01024036|147525617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.418||||0.0084|TWO_SIDED|95.0|0.214|0.815|||Log Rank||Hazard ratio and 95% CI from a Cox proportional hazards model|||0.815|0.214|0.0084
73875878|NCT02831764|147293911|OTHER||Ratio of geometric means|0.693||||0.005|TWO_SIDED|95.0|0.538|0.892|||MMRM||Week 48. Urine B2M.|||0.892|0.538|0.005
73875879|NCT02831764|147293911|OTHER||Ratio of geometric means|0.889||||0.036|TWO_SIDED|95.0|0.796|0.992|||MMRM||Week 24. Urine Albumin/Creatinine.|||0.992|0.796|0.036
73875880|NCT02831764|147293911|OTHER||Ratio of geometric means|0.938||||0.308|TWO_SIDED|95.0|0.83|1.061|||MMRM||Week 48. Urine Albumin/Creatinine.|||1.061|0.830|0.308
73875881|NCT02831764|147293911|OTHER||Ratio of geometric means|0.781||||0.007|TWO_SIDED|95.0|0.654|0.934|||MMRM||Week 24. Urine B2M/Urine Creatinine.|||0.934|0.654|0.007
73875882|NCT02831764|147293911|OTHER||Ratio of geometric means|0.742||||0.012|TWO_SIDED|95.0|0.588|0.935|||MMRM||Week 48. Urine B2M/Urine Creatinine.|||0.935|0.588|0.012
73875883|NCT02831764|147293911|OTHER||Ratio of geometric means|0.979||||0.728|TWO_SIDED|95.0|0.868|1.104|||MMRM||Week 24. Urine Phosphate.|||1.104|0.868|0.728
73875884|NCT02831764|147293911|OTHER||Ratio of geometric means|1.062||||0.311|TWO_SIDED|95.0|0.945|1.194|||MMRM||Week 48. Urine Phosphate.|||1.194|0.945|0.311
73989583|NCT01024036|147525618|SUPERIORITY_OR_OTHER||Difference of hemoglobin response rates|61.3||||0.0002|TWO_SIDED|95.0|28.3|85.1|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care \[BSC\] arm minus hemoglobin response rate for Placebo+BSC arm.|||85.1|28.3|0.0002
73989584|NCT01024036|147525619|SUPERIORITY_OR_OTHER||Difference of hemoglobin response rates|41.9||||0.0195|TWO_SIDED|95.0|7.8|70.7|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care \[BSC\] arm minus hemoglobin response rate for Placebo+BSC arm.|||70.7|7.8|0.0195
73989585|NCT01817712|147525627|SUPERIORITY||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.46|3.14|||Regression, Logistic|||||3.14|1.46|<0.001
73989586|NCT01817712|147525628|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|Site used as strata||||||0.004
73989587|NCT01817712|147525629|OTHER|Longitudinal analysis of PCL-5 (change from baseline)|Mean Difference (Net)|-1.9||||0.07|TWO_SIDED|95.0|-3.91|0.12|||Mixed Models Analysis|||||0.12|-3.91|0.07
73989588|NCT02808975|147525682|SUPERIORITY||||||=|0.049|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.049
73989589|NCT02808975|147525683|SUPERIORITY||||||=|0.067|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.067
73989590|NCT02808975|147525684|SUPERIORITY||||||=|0.003|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.003
73989591|NCT02808975|147525685|SUPERIORITY||||||=|0.313|||||||ANCOVA|Across all strata, P-values are calculated from ANCOVA with stratum, baseline value, and treatment in the model.||||||=0.313
74035088|NCT03725202|147622568|SUPERIORITY|Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates|Cox Proportional Hazard|0.75|||=|0.1778|TWO_SIDED|95.0|0.499|1.136|||Log-rank test|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.136|0.499|=0.1778
74035089|NCT03725202|147622569|SUPERIORITY|The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.|Odds Ratio (OR)|0.47|||=|0.0014|TWO_SIDED|95.0|0.29|0.74|||Stratified Test for Odds Ratio|This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.74|0.29|=0.0014
74035090|NCT03725202|147622569|SUPERIORITY|The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.|Odds Ratio (OR)|0.6|||=|0.0633|TWO_SIDED|95.0|0.35|1.03|||Stratified Test for Odds Ratio|This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.03|0.35|=0.0633
74035091|NCT03725202|147622570|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|30.3|||<|0.0001|TWO_SIDED|95.0|20.4|40.2|||Cochran-Mantel-Haenszel|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||40.2|20.4|<0.0001
73875885|NCT02831764|147293911|OTHER||Ratio of geometric means|0.826|||<|0.001|TWO_SIDED|95.0|0.769|0.887|||MMRM||Week 24. Urine Protein/Creatinine.|||0.887|0.769|<0.001
73989592|NCT02808975|147525686|SUPERIORITY||||||=|0.746|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.746
73989593|NCT02106195|147525737|SUPERIORITY|Change from Baseline to Day 28|Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|3.04||0.324|TWO_SIDED|95.0|-3.7|1.4|||t-test, 2 sided|||||1.4|-3.7|0.324
74035092|NCT03725202|147622570|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|23.5|||<|0.0001|TWO_SIDED|95.0|11.7|35.3|||Cochran-Mantel-Haenszel|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||35.3|11.7|<0.0001
74035093|NCT03725202|147622571|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|20.8|||=|0.0002|TWO_SIDED|95.0|9.7|31.9|||Cochran-Mantel-Haenszel|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||31.9|9.7|=0.0002
74035094|NCT03725202|147622571|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|3.2|||=|0.6276|TWO_SIDED|95.0|-9.6|16.0|||Cochran-Mantel-Haenszel|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||16.0|-9.6|=0.6276
74035095|NCT03725202|147622572|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|3.7526|STANDARD_ERROR_OF_MEAN|1.1981|=|0.0019|TWO_SIDED|95.0|1.3932|6.1119|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.1119|1.3932|=0.0019
73989594|NCT04702893|147525772|OTHER|No formal hypotheses were tested.||||||0.1185|||||||Z-test of correlation|||||||0.1185
73989595|NCT04702893|147525773|OTHER|No formal hypotheses were tested.||||||0.5135|||||||Z-test of correlation|||||||0.5135
73875886|NCT02831764|147293911|OTHER||Ratio of geometric means|0.86|||<|0.001|TWO_SIDED|95.0|0.795|0.93|||MMRM||Week 48. Urine Protein/Creatinine.|||0.930|0.795|<0.001
73989596|NCT04702893|147525774|OTHER|No formal hypotheses were tested.||||||0.0764|||||||Z-test of correlation|||||||0.0764
73989597|NCT04702893|147525775|OTHER|No formal hypotheses were tested.||||||0.3478|||||||Z-test of correlation|||||||0.3478
73989598|NCT04469465|147525780|SUPERIORITY|||||||0.0007|||||||Re-randomization Test|||Interim Efficacy Analysis||||0.0007
73989599|NCT04469465|147525780|SUPERIORITY|||||||0.0007|||||||Re-randomization Test|||Full Analysis||||0.0007
73989600|NCT04469465|147525780|SUPERIORITY||LS Mean Difference|24.44|STANDARD_ERROR_OF_MEAN|3.751|<|0.0001|TWO_SIDED|95.0|16.9|31.99|||Mixed Models Analysis|||Interim Efficacy Analysis||31.99|16.90|<0.0001
73989601|NCT04469465|147525780|SUPERIORITY||Difference|23.46|STANDARD_ERROR_OF_MEAN|3.585|<|0.0001|TWO_SIDED|95.0|16.31|30.61|||Mixed Models Analysis|||Full Analysis||30.61|16.31|<0.0001
73875887|NCT02831764|147293911|OTHER||Ratio of geometric means|0.796||||0.003|TWO_SIDED|95.0|0.683|0.927|||MMRM||Week 24. Urine RBP 4|||0.927|0.683|0.003
73875888|NCT02831764|147293911|OTHER||Ratio of geometric means|0.903||||0.2|TWO_SIDED|95.0|0.773|1.056|||MMRM||Week 48. Urine RBP 4|||1.056|0.773|0.200
73875889|NCT02831764|147293911|OTHER||Ratio of geometric means|0.826||||0.003|TWO_SIDED|95.0|0.728|0.936|||MMRM||Week 24. Urine RBP 4/Urine Creatinine|||0.936|0.728|0.003
73875890|NCT02831764|147293911|OTHER||Ratio of geometric means|0.888||||0.052|TWO_SIDED|95.0|0.787|1.001|||MMRM||Week 48. Urine RBP 4/Urine Creatinine|||1.001|0.787|0.052
73875891|NCT02831764|147293912|OTHER||Ratio of geometric means|0.942||||0.338|TWO_SIDED|95.0|0.833|1.065|||MMRM||Week 96. Urine Albumin/Creatinine.|||1.065|0.833|0.338
73989602|NCT03305809|147525817|SUPERIORITY||Posterior Mean Difference|-0.89|||||TWO_SIDED|95.0|-2.776|0.969|||||Analyses were conducted using a bayesian mixed-model repeated measures (MMRM), and posterior mean change difference is reported.|||0.969|-2.776|
73989603|NCT03305809|147525817|SUPERIORITY||Posterior Mean Difference|-0.08|||||TWO_SIDED|95.0|-1.996|1.879|||||Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.|||1.879|-1.996|
73875892|NCT02831764|147293912|OTHER||Ratio of geometric means|0.671|||<|0.001|TWO_SIDED|95.0|0.545|0.826|||MMRM||Week 96. Urine B2M/Urine Creatinine.|||0.826|0.545|<0.001
73875893|NCT02831764|147293912|OTHER||Ratio of geometric means|1.082||||0.174|TWO_SIDED|95.0|0.966|1.213|||MMRM||Week 96. Urine Phosphate.|||1.213|0.966|0.174
73989604|NCT03305809|147525817|SUPERIORITY||Posterior Mean Difference|-0.78|||||TWO_SIDED|95.0|-2.873|1.277|||||Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.|||1.277|-2.873|
73989605|NCT03305809|147525818|SUPERIORITY||Mean Difference (Net)|-0.2||||0.273|TWO_SIDED|95.0|-0.54|0.15|||Mixed Models Analysis|||||0.15|-0.54|0.273
73875894|NCT02831764|147293912|OTHER||Ratio of geometric means|0.873|||<|0.001|TWO_SIDED|95.0|0.806|0.946|||MMRM||Week 96. Urine Protein/Creatinine.|||0.946|0.806|<0.001
73989606|NCT03305809|147525818|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.02|-0.3|||Mixed Models Analysis|||||-0.30|-1.02|<0.001
74089933|NCT02312713|147732644|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.56|TWO_SIDED|95.0|-1.56|2.86|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||2.86|-1.56|0.56
73875895|NCT02831764|147293912|OTHER||Ratio of geometric means|0.8|||<|0.001|TWO_SIDED|95.0|0.716|0.894|||MMRM||Week 96. Urine RBP 4/Urine Creatinine|||0.894|0.716|<0.001
73989607|NCT03305809|147525818|SUPERIORITY||Mean Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.29|-0.53|||Mixed Models Analysis|||||-0.53|-1.29|< 0.001
73989608|NCT03305809|147525819|SUPERIORITY||Mean Difference (Net)|-70.71|STANDARD_ERROR_OF_MEAN|68.495||0.303|TWO_SIDED|95.0|-205.53|64.11|||Mixed Models Analysis|||||64.11|-205.53|0.303
73989609|NCT03305809|147525819|SUPERIORITY||Median Difference (Net)|-107.02|STANDARD_ERROR_OF_MEAN|69.647||0.125|TWO_SIDED|95.0|-244.09|30.06|||Mixed Models Analysis|||||30.06|-244.09|0.125
73989610|NCT03305809|147525819|SUPERIORITY||Mean Difference (Net)|-123.72|STANDARD_ERROR_OF_MEAN|72.892||0.091|TWO_SIDED|95.0|-267.18|19.74|||Mixed Models Analysis|||||19.74|-267.18|0.091
73989611|NCT03305809|147525820|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.985||0.686|TWO_SIDED|95.0|-2.34|1.54|||Mixed Models Analysis|||||1.54|-2.34|0.686
73989612|NCT03305809|147525820|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|1.011||0.485|TWO_SIDED|95.0|-2.7|1.28|||Mixed Models Analysis|||||1.28|-2.70|0.485
73989613|NCT03305809|147525820|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|1.064||0.406|TWO_SIDED|95.0|-2.98|1.21|||Mixed Models Analysis|||||1.21|-2.98|0.406
73875896|NCT02831764|147293913|OTHER||Ratio of geometric means|0.971||||0.658|TWO_SIDED|95.0|0.852|1.107|||MMRM||Week 144. Urine Albumin/Creatinine.|||1.107|0.852|0.658
73875897|NCT02831764|147293913|OTHER||Ratio of geometric means|0.584|||<|0.001|TWO_SIDED|95.0|0.483|0.706|||MMRM||Week 144. Urine B2M/Urine Creatinine.|||0.706|0.483|<0.001
73875898|NCT02831764|147293913|OTHER||Ratio of geometric means|1.0||||0.993|TWO_SIDED|95.0|0.892|1.12|||MMRM||Week 144. Urine Phosphate.|||1.120|0.892|0.993
73875899|NCT02831764|147293913|OTHER||Ratio of geometric means|0.847|||<|0.001|TWO_SIDED|95.0|0.785|0.913|||MMRM||Week 144. Urine Protein/Creatinine.|||0.913|0.785|<0.001
73875900|NCT02831764|147293913|OTHER||Ratio of geometric means|0.739|||<|0.001|TWO_SIDED|95.0|0.667|0.819|||MMRM||Week 144. Urine RBP 4/Urine Creatinine|||0.819|0.667|<0.001
73875901|NCT02831764|147293914|OTHER||Mean Difference (Net)|-2.66|||<|0.001|TWO_SIDED|95.0|-3.25|-2.08|||MMRM||Week 24, Bone ALP|||-2.08|-3.25|<0.001
73875902|NCT02831764|147293914|OTHER||Mean Difference (Net)|-3.09|||<|0.001|TWO_SIDED|95.0|-3.75|-2.44|||MMRM||Week 48, Bone ALP|||-2.44|-3.75|<0.001
73875903|NCT02831764|147293914|OTHER||Mean Difference (Net)|-4.67|||<|0.001|TWO_SIDED|95.0|-5.63|-3.71|||MMRM||Week 28, Serum Osteocalcin|||-3.71|-5.63|<0.001
73875904|NCT02831764|147293914|OTHER||Mean Difference (Net)|-5.9|||<|0.001|TWO_SIDED|95.0|-6.89|-4.91|||MMRM||Week 48, Serum Osteocalcin|||-4.91|-6.89|<0.001
73875905|NCT02831764|147293914|OTHER||Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-16.4|-10.6|||MMRM||Week 24, Serum PINP|||-10.6|-16.4|<0.001
73875906|NCT02831764|147293914|OTHER||Mean Difference (Net)|-12.8|||<|0.001|TWO_SIDED|95.0|-15.4|-10.2|||MMRM||Week 48, Serum PINP|||-10.2|-15.4|<0.001
73989614|NCT03305809|147525821|SUPERIORITY||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.603||0.464|TWO_SIDED|95.0|-0.74|1.63|||Mixed Models Analysis|||||1.63|-0.74|0.464
73989615|NCT03305809|147525821|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.623||0.72|TWO_SIDED|95.0|-1.0|1.45|||Mixed Models Analysis|||||1.45|-1.00|0.720
73989616|NCT03305809|147525821|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.655||0.149|TWO_SIDED|95.0|-0.34|2.24|||Mixed Models Analysis|||||2.24|-0.34|0.149
73989617|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|1.213||0.607|TWO_SIDED|95.0|-3.01|1.76|||Mixed Models Analysis|||Total Score||1.76|-3.01|0.607
73989618|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|1.265||0.18|TWO_SIDED|95.0|-4.19|0.79|||Mixed Models Analysis|||Total Score||0.79|-4.19|0.180
73989619|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.75|STANDARD_ERROR_OF_MEAN|1.325||0.572|TWO_SIDED|95.0|-3.36|1.86|||Mixed Models Analysis|||Total Score||1.86|-3.36|0.572
73989620|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.173||0.32|TWO_SIDED|95.0|-0.51|0.17|||Mixed Models Analysis|||Delusions||0.17|-0.51|0.320
73875907|NCT02831764|147293914|OTHER||Mean Difference (Net)|-0.127|||<|0.001|TWO_SIDED|95.0|-0.164|-0.09|||MMRM||Week 24, CTX-1|||-0.0900|-0.1640|<0.001
73875908|NCT02831764|147293914|OTHER||Mean Difference (Net)|-0.2043|||<|0.001|TWO_SIDED|95.0|-0.2532|-0.1554|||MMRM||Week 48, CTX-1|||-0.1554|-0.2532|<0.001
73875909|NCT02831764|147293915|OTHER||Mean Difference (Net)|-2.13|||<|0.001|TWO_SIDED|95.0|-2.72|-1.54|||MMRM||Week 96, Bone ALP|||-1.54|-2.72|<0.001
73875910|NCT02831764|147293915|OTHER||Mean Difference (Net)|-3.77|||<|0.001|TWO_SIDED|95.0|-4.69|-2.85|||MMRM||Week 96, Serum Osteocalcin|||-2.85|-4.69|<0.001
73875911|NCT02831764|147293915|OTHER||Mean Difference (Net)|-12.6|||<|0.001|TWO_SIDED|95.0|-16.8|-8.3|||MMRM||Week 96, Serum PINP|||-8.3|-16.8|<0.001
73875912|NCT02831764|147293915|OTHER||Mean Difference (Net)|-0.1183|||<|0.001|TWO_SIDED|95.0|-0.1529|-0.0838|||MMRM||Week 96, CTX-1|||-0.0838|-0.1529|<0.001
73875913|NCT02831764|147293916|OTHER||Mean Difference (Net)|-2.13|||<|0.001|TWO_SIDED|95.0|-2.74|-1.53|||MMRM||Week 144, Bone ALP|||-1.53|-2.74|<0.001
73875914|NCT02831764|147293916|OTHER||Mean Difference (Net)|-3.89|||<|0.001|TWO_SIDED|95.0|-4.87|-2.91|||MMRM||Week 144, Serum Osteocalcin|||-2.91|-4.87|<0.001
73875915|NCT02831764|147293916|OTHER||Mean Difference (Net)|-9.5|||<|0.001|TWO_SIDED|95.0|-12.8|-6.2|||MMRM||Week 144, Serum PINP|||-6.2|-12.8|<0.001
73989621|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.18||0.037|TWO_SIDED|95.0|-0.73|-0.02|||Mixed Models Analysis|||Delusions||-0.02|-0.73|0.037
73875916|NCT02831764|147293916|OTHER||Mean Difference (Net)|-0.1364|||<|0.001|TWO_SIDED|95.0|-0.1739|-0.0988|||MMRM||Week 144, CTX-1|||-0.0988|-0.1739|<0.001
73875917|NCT02831764|147293917|OTHER||Mean Difference (Net)|-4.2||||0.015|TWO_SIDED|95.0|-7.5|-0.8|||MMRM||Week 24|||-0.8|-7.5|0.015
73875918|NCT02831764|147293917|OTHER||Mean Difference (Net)|-0.1||||0.96|TWO_SIDED|95.0|-2.8|2.6|||MMRM||Week 48|||2.6|-2.8|0.960
73875919|NCT02831764|147293918|OTHER||Mean Difference (Net)|-3.0||||0.048|TWO_SIDED|95.0|-5.9|0.0|||MMRM||Week 96, Serum Vitamin D|||0.0|-5.9|0.048
74039678|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.91||||0.0162|TWO_SIDED|95.0|1.13|3.25|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.25|1.13|0.0162
73875920|NCT02831764|147293919|OTHER||Mean Difference (Net)|-0.2||||0.887|TWO_SIDED|95.0|-3.6|3.1|||MMRM||Week 144, Serum Vitamin D|||3.1|-3.6|0.887
73875921|NCT02831764|147293926|OTHER||Mean Difference (Final Values)|3.5|||<|0.001|TWO_SIDED|95.0|1.5|5.6|||Fisher Exact||Week 24|||5.6|1.5|<0.001
73875922|NCT02831764|147293926|OTHER||Mean Difference (Final Values)|2.8||||0.037|TWO_SIDED|95.0|0.2|5.4|||Fisher Exact||Week 48|||5.4|0.2|0.037
73875923|NCT02831764|147293927|OTHER||Mean Difference (Final Values)|3.1||||0.045|TWO_SIDED|95.0|0.2|6.1|||Fisher Exact||Week 96|||6.1|0.2|0.045
73875924|NCT02831764|147293928|OTHER||Mean Difference (Final Values)|2.6||||0.16|TWO_SIDED|95.0|-0.8|6.0|||Fisher Exact||Week 144|||6.0|-0.8|0.160
73875925|NCT02831764|147293933|OTHER||Mean Difference (Net)|37.8|||||TWO_SIDED|95.0|9.98|65.62|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||65.62|9.98|
73875926|NCT02831764|147293933|OTHER||Mean Difference (Net)|-26.81|||||TWO_SIDED|95.0|-82.72|29.1|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||29.10|-82.72|
73875927|NCT02831764|147293933|OTHER||Mean Difference (Net)|61.72|||||TWO_SIDED|95.0|-26.94|150.39|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||150.39|-26.94|
73875928|NCT02831764|147293933|OTHER||Mean Difference (Net)|22.57|||||TWO_SIDED|95.0|-3.42|48.55|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||48.55|-3.42|
73989622|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.558|TWO_SIDED|95.0|-0.49|0.26|||Mixed Models Analysis|||Delusions||0.26|-0.49|0.558
73989623|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.182||0.924|TWO_SIDED|95.0|-0.38|0.34|||Mixed Models Analysis|||Hallucinations||0.34|-0.38|0.924
73989624|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.189||0.061|TWO_SIDED|95.0|-0.73|0.02|||Mixed Models Analysis|||Hallucinations||0.02|-0.73|0.061
73989625|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.199||0.148|TWO_SIDED|95.0|-0.68|0.1|||Mixed Models Analysis|||Hallucinations||0.10|-0.68|0.148
73989626|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.18||0.552|TWO_SIDED|95.0|-0.46|0.25|||Mixed Models Analysis|||Agitation/Aggression||0.25|-0.46|0.552
73875929|NCT02831764|147293933|OTHER||Mean Difference (Net)|38.99|||||TWO_SIDED|95.0|5.88|72.09|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||72.09|5.88|
73875930|NCT02831764|147293933|OTHER||Mean Difference (Net)|-9.9|||||TWO_SIDED|95.0|-53.1|33.3|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||33.30|-53.10|
73875931|NCT02831764|147293933|OTHER||Mean Difference (Net)|65.53|||||TWO_SIDED|95.0|-14.43|145.5|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||145.50|-14.43|
73875932|NCT02831764|147293933|OTHER||Mean Difference (Net)|59.66|||||TWO_SIDED|95.0|-8.62|127.94|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||127.94|-8.62|
73875933|NCT02831764|147293933|OTHER||Mean Difference (Net)|19.23|||||TWO_SIDED|95.0|-7.65|46.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.10|-7.65|
73875934|NCT02831764|147293933|OTHER||Mean Difference (Net)|19.04|||||TWO_SIDED|95.0|-11.06|49.13|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||49.13|-11.06|
73875935|NCT02831764|147293933|OTHER||Mean Difference (Net)|43.25|||||TWO_SIDED|95.0|-30.59|117.09|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||117.09|-30.59|
73989627|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.188||0.735|TWO_SIDED|95.0|-0.43|0.31|||Mixed Models Analysis|||Agitation/Aggression||0.31|-0.43|0.735
73989628|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.197||0.224|TWO_SIDED|95.0|-0.63|0.15|||Mixed Models Analysis|||Agitation/Aggression||0.15|-0.63|0.224
73989629|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.216||0.783|TWO_SIDED|95.0|-0.37|0.48|||Mixed Models Analysis|||Depression/Dysphoria||0.48|-0.37|0.783
73989630|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.226||0.64|TWO_SIDED|95.0|-0.55|0.34|||Mixed Models Analysis|||Depression/Dysphoria||0.34|-0.55|0.640
73989631|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.236||0.592|TWO_SIDED|95.0|-0.59|0.34|||Mixed Models Analysis|||Depression/Dysphoria||0.34|-0.59|0.592
73989632|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.197||0.993|TWO_SIDED|95.0|-0.39|0.39|||Mixed Models Analysis|||Anxiety||0.39|-0.39|0.993
73989633|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.205||0.29|TWO_SIDED|95.0|-0.19|0.62|||Mixed Models Analysis|||Anxiety||0.62|-0.19|0.290
73989634|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.215||0.722|TWO_SIDED|95.0|-0.5|0.35|||Mixed Models Analysis|||Anxiety||0.35|-0.50|0.722
74035096|NCT03725202|147622572|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|2.6094|STANDARD_ERROR_OF_MEAN|1.4185|=|0.067|TWO_SIDED|95.0|-0.1841|5.4028|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||5.4028|-0.1841|=0.0670
74035097|NCT03725202|147622573|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.6||||0.001|TWO_SIDED|95.0|0.4|0.8|||Poisson regression model|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.8|0.4|0.0010
74089934|NCT02312713|147732644|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.19||||0.01|TWO_SIDED|95.0|0.48|3.9|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.9|0.48|0.01
73875936|NCT02831764|147293933|OTHER||Mean Difference (Net)|12.8|||||TWO_SIDED|95.0|-72.14|97.73|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||97.73|-72.14|
73989635|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.097||0.246|TWO_SIDED|95.0|-0.3|0.08|||Mixed Models Analysis|||Elation/Euphoria||0.08|-0.30|0.246
73989636|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.101||0.175|TWO_SIDED|95.0|-0.34|0.06|||Mixed Models Analysis|||Elation/Euphoria||0.06|-0.34|0.175
73989637|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.106||0.482|TWO_SIDED|95.0|-0.28|0.13|||Mixed Models Analysis|||Elation/Euphoria||0.13|-0.28|0.482
73989638|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|0.266||0.091|TWO_SIDED|95.0|-0.97|0.07|||Mixed Models Analysis|||Apathy/Indifference||0.07|-0.97|0.091
73989639|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.278||0.248|TWO_SIDED|95.0|-0.87|0.23|||Mixed Models Analysis|||Apathy/Indifference||0.23|-0.87|0.248
73989640|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.29||0.516|TWO_SIDED|95.0|-0.76|0.38|||Mixed Models Analysis|||Apathy/Indifference||0.38|-0.76|0.516
73989641|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.114||0.875|TWO_SIDED|95.0|-0.21|0.24|||Mixed Models Analysis|||Disinhibition||0.24|-0.21|0.875
73989642|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.119||0.005|TWO_SIDED|95.0|0.1|0.57|||Mixed Models Analysis|||Disinhibition||0.57|0.10|0.005
73989643|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.125||0.761|TWO_SIDED|95.0|-0.21|0.28|||Mixed Models Analysis|||Disinhibition||0.28|-0.21|0.761
73989644|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.181||0.183|TWO_SIDED|95.0|-0.6|0.12|||Mixed Models Analysis|||Irritability/Lability||0.12|-0.60|0.183
73989645|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.189||0.765|TWO_SIDED|95.0|-0.43|0.31|||Mixed Models Analysis|||Irritability/Lability||0.31|-0.43|0.765
73989646|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.198||0.279|TWO_SIDED|95.0|-0.18|0.61|||Mixed Models Analysis|||Irritability/Lability||0.61|-0.18|0.279
73989647|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.147||0.252|TWO_SIDED|95.0|-0.12|0.46|||Mixed Models Analysis|||Aberrant Motor Behavior||0.46|-0.12|0.252
73989648|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.154||0.526|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Aberrant Motor Behavior||0.20|-0.40|0.526
73989649|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.161||0.8|TWO_SIDED|95.0|-0.28|0.36|||Mixed Models Analysis|||Aberrant Motor Behavior||0.36|-0.28|0.800
73989650|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.623|TWO_SIDED|95.0|-0.59|0.98|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.98|-0.59|0.623
73989651|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.418||0.354|TWO_SIDED|95.0|-1.21|0.44|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.44|-1.21|0.354
73989652|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.437||0.809|TWO_SIDED|95.0|-0.97|0.75|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.75|-0.97|0.809
73989653|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.376||0.79|TWO_SIDED|95.0|-0.84|0.64|||Mixed Models Analysis|||Appetite/Eating Disorders||0.64|-0.84|0.790
73989654|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.392||0.28|TWO_SIDED|95.0|-1.2|0.35|||Mixed Models Analysis|||Appetite/Eating Disorders||0.35|-1.20|0.280
73989655|NCT03305809|147525822|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.412||0.797|TWO_SIDED|95.0|-0.7|0.92|||Mixed Models Analysis|||Appetite/Eating Disorders||0.92|-0.70|0.797
73989656|NCT03305809|147525823|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.61||0.247|TWO_SIDED|95.0|-1.91|0.49|||Mixed Models Analysis|||||0.49|-1.91|0.247
73989657|NCT03305809|147525823|SUPERIORITY||Mean Difference (Net)|-0.88|STANDARD_ERROR_OF_MEAN|0.631||0.164|TWO_SIDED|95.0|-2.12|0.36|||Mixed Models Analysis|||||0.36|-2.12|0.164
73989658|NCT03305809|147525823|SUPERIORITY||Mean Difference (Net)|-1.59|STANDARD_ERROR_OF_MEAN|0.663||0.017|TWO_SIDED|95.0|-2.9|-0.29|||Mixed Models Analysis|||||-0.29|-2.90|0.017
73989659|NCT03305809|147525824|SUPERIORITY||Mean Difference (Net)|-6.41|STANDARD_ERROR_OF_MEAN|2.86||0.026|TWO_SIDED|95.0|-12.04|-0.77|||Mixed Models Analysis|||||-0.77|-12.04|0.026
73989660|NCT03305809|147525824|SUPERIORITY||Mean Difference (Net)|-7.39|STANDARD_ERROR_OF_MEAN|2.969||0.014|TWO_SIDED|95.0|-13.24|-1.53|||Mixed Models Analysis|||||-1.53|-13.24|0.014
74089935|NCT02312713|147732644|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.71||||0.06|TWO_SIDED|95.0|-0.1|3.52|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||3.52|-0.1|0.06
73875937|NCT02831764|147293933|OTHER||Mean Difference (Net)|62.01|||||TWO_SIDED|95.0|-16.09|140.12|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||140.12|-16.09|
73989661|NCT03305809|147525824|SUPERIORITY||Mean Difference (Net)|-10.6|STANDARD_ERROR_OF_MEAN|3.104|<|0.001|TWO_SIDED|95.0|-16.72|-4.48|||Mixed Models Analysis|||||-4.48|-16.72|<0.001
73989662|NCT03305809|147525825|SUPERIORITY||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|1.362||0.683|TWO_SIDED|95.0|-2.13|3.24|||Mixed Models Analysis|||||3.24|-2.13|0.683
73989663|NCT03305809|147525825|SUPERIORITY||Mean Difference (Net)|2.41|STANDARD_ERROR_OF_MEAN|1.413||0.089|TWO_SIDED|95.0|-0.37|5.19|||Mixed Models Analysis|||||5.19|-0.37|0.089
73989664|NCT03305809|147525825|SUPERIORITY||Mean Difference (Net)|1.56|STANDARD_ERROR_OF_MEAN|1.489||0.294|TWO_SIDED|95.0|-1.37|4.49|||Mixed Models Analysis|||||4.49|-1.37|0.294
73989665|NCT03305809|147525826|SUPERIORITY||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|0.389||0.105|TWO_SIDED|95.0|-0.13|1.4|||Mixed Models Analysis|||||1.40|-0.13|0.105
73989666|NCT03305809|147525826|SUPERIORITY||Mean Difference (Net)|1.07|STANDARD_ERROR_OF_MEAN|0.406||0.009|TWO_SIDED|95.0|0.27|1.87|||Mixed Models Analysis|||||1.87|0.27|0.009
73989667|NCT03305809|147525826|SUPERIORITY||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|0.428||0.253|TWO_SIDED|95.0|-0.35|1.33|||Mixed Models Analysis|||||1.33|-0.35|0.253
73989668|NCT03305809|147525827|SUPERIORITY||Mean Difference (Net)|-1.74|STANDARD_ERROR_OF_MEAN|0.923||0.061|TWO_SIDED|95.0|-3.56|0.08|||Mixed Models Analysis|||Motor Experiences of Daily Living||0.08|-3.56|0.061
73989669|NCT03305809|147525827|SUPERIORITY||Mean Difference (Net)|-2.37|STANDARD_ERROR_OF_MEAN|0.96||0.014|TWO_SIDED|95.0|-4.26|-0.47|||Mixed Models Analysis|||Motor Experiences of Daily Living||-0.47|-4.26|0.014
73989670|NCT03305809|147525827|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|1.013|<|0.001|TWO_SIDED|95.0|-5.5|-1.51|||Mixed Models Analysis|||Motor Experiences of Daily Living||-1.51|-5.50|<0.001
73989671|NCT03305809|147525827|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.822||0.074|TWO_SIDED|95.0|-6.86|0.32|||Mixed Models Analysis|||Motor Exam||0.32|-6.86|0.074
73989672|NCT03305809|147525827|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.891||0.085|TWO_SIDED|95.0|-7.0|0.45|||Mixed Models Analysis|||Motor Exam||0.45|-7.00|0.085
73989673|NCT03305809|147525827|SUPERIORITY||Mean Difference (Net)|-4.23|STANDARD_ERROR_OF_MEAN|1.959||0.032|TWO_SIDED|95.0|-8.09|-0.37|||Mixed Models Analysis|||Motor Exam||-0.37|-8.09|0.032
73989674|NCT03305809|147525829|SUPERIORITY||Mean Difference (Net)|0.3||||0.898|TWO_SIDED|95.0|-4.92|5.61|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||5.61|-4.92|0.898
73989675|NCT03305809|147525829|SUPERIORITY||Mean Difference (Net)|0.6||||0.821|TWO_SIDED|95.0|-4.71|5.94|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||5.94|-4.71|0.821
73989676|NCT03305809|147525829|SUPERIORITY||Mean Difference (Net)|9.4|||<|0.001|TWO_SIDED|95.0|4.11|14.61|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||14.61|4.11|<0.001
73989677|NCT03305809|147525829|SUPERIORITY||Mean Difference (Net)|0.3||||0.805|TWO_SIDED|95.0|-2.4|3.08|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.08|-2.40|0.805
73989678|NCT03305809|147525829|SUPERIORITY||Mean Difference (Net)|0.9||||0.513|TWO_SIDED|95.0|-1.85|3.69|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.69|-1.85|0.513
73989679|NCT03305809|147525829|SUPERIORITY||Mean Difference (Net)|3.6||||0.011|TWO_SIDED|95.0|0.83|6.28|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||6.28|0.83|0.011
73989680|NCT03305809|147525830|SUPERIORITY||Mean Difference (Net)|2.5||||0.065|TWO_SIDED|95.0|-0.16|5.08|||Mixed Models Analysis|||||5.08|-0.16|0.065
73989681|NCT03305809|147525830|SUPERIORITY||Mean Difference (Net)|3.6||||0.008|TWO_SIDED|95.0|0.93|6.21|||Mixed Models Analysis|||||6.21|0.93|0.008
73989682|NCT03305809|147525830|SUPERIORITY||Mean Difference (Net)|8.7|||<|0.001|TWO_SIDED|95.0|6.06|11.27|||Mixed Models Analysis|||||11.27|6.06|<0.001
73989683|NCT03305809|147525831|SUPERIORITY||Mean Difference (Net)|1.6||||0.339|TWO_SIDED|95.0|-1.72|4.99|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||4.99|-1.72|0.339
73989684|NCT03305809|147525831|SUPERIORITY||Mean Difference (Net)|1.2||||0.486|TWO_SIDED|95.0|-2.26|4.73|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||4.73|-2.26|0.486
73989685|NCT03305809|147525831|SUPERIORITY||Mean Difference (Net)|4.2||||0.024|TWO_SIDED|95.0|0.56|7.81|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||7.81|0.56|0.024
73989686|NCT03305809|147525831|SUPERIORITY||Mean Difference (Net)|-0.1||||0.935|TWO_SIDED|95.0|-2.04|1.88|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||1.88|-2.04|0.935
73989687|NCT03305809|147525831|SUPERIORITY||Mean Difference (Net)|0.7||||0.505|TWO_SIDED|95.0|-1.34|2.72|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||2.72|-1.34|0.505
73989688|NCT03305809|147525831|SUPERIORITY||Mean Difference (Net)|1.22||||0.266|TWO_SIDED|95.0|-0.91|3.3|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.30|-0.91|0.266
73989689|NCT03305809|147525832|SUPERIORITY||Mean Difference (Net)|0.6||||0.55|TWO_SIDED|95.0|-1.28|2.41|||Mixed Models Analysis|||||2.41|-1.28|0.550
73989690|NCT03305809|147525832|SUPERIORITY||Mean Difference (Net)|1.8||||0.069|TWO_SIDED|95.0|-0.14|3.68|||Mixed Models Analysis|||||3.68|-0.14|0.069
73989691|NCT03305809|147525832|SUPERIORITY||Mean Difference (Net)|2.9||||0.005|TWO_SIDED|95.0|0.89|4.83|||Mixed Models Analysis|||||4.83|0.89|0.005
73989692|NCT03305809|147525833|SUPERIORITY||Mean Difference (Net)|-7.0||||0.045|TWO_SIDED|95.0|-13.92|-0.15|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||-0.15|-13.92|0.045
73989693|NCT03305809|147525833|SUPERIORITY||Mean Difference (Net)|3.1||||0.39|TWO_SIDED|95.0|-4.05|10.32|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||10.32|-4.05|0.390
73989694|NCT03305809|147525833|SUPERIORITY||Mean Difference (Net)|-1.1||||0.768|TWO_SIDED|95.0|-8.32|6.16|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||6.16|-8.32|0.768
73989695|NCT03305809|147525833|SUPERIORITY||Mean Difference (Net)|-4.3||||0.041|TWO_SIDED|95.0|-8.48|-0.17|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||-0.17|-8.48|0.041
73989696|NCT03305809|147525833|SUPERIORITY||Mean Difference (Net)|-0.5||||0.802|TWO_SIDED|95.0|-4.81|3.72|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.72|-4.81|0.802
73989697|NCT03305809|147525833|SUPERIORITY||Mean Difference (Net)|-2.4||||0.284|TWO_SIDED|95.0|-6.67|1.97|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||1.97|-6.67|0.284
73989698|NCT03305809|147525834|SUPERIORITY||Mean Difference (Net)|0.0||||0.996|TWO_SIDED|95.0|-4.17|4.19|||Mixed Models Analysis|||||4.19|-4.17|0.996
73989699|NCT03305809|147525834|SUPERIORITY||Mean Difference (Net)|-0.7||||0.767|TWO_SIDED|95.0|-4.99|3.69|||Mixed Models Analysis|||||3.69|-4.99|0.767
73989700|NCT03305809|147525834|SUPERIORITY||Mean Difference (Net)|-0.6||||0.791|TWO_SIDED|95.0|-4.96|3.79|||Mixed Models Analysis|||||3.79|-4.96|0.791
73989701|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|0.98||||0.312|TWO_SIDED|95.0|-0.93|2.88|||ANCOVA|||Week 12||2.88|-0.93|0.312
73989702|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|1.03||||0.289|TWO_SIDED|95.0|-0.89|2.95|||ANCOVA|||Week 12||2.95|-0.89|0.289
73989703|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|1.56||||0.141|TWO_SIDED|95.0|-0.53|3.65|||ANCOVA|||Week 12||3.65|-0.53|0.141
73989704|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|0.06||||0.954|TWO_SIDED|95.0|-1.89|2.01|||ANCOVA|||Week 12||2.01|-1.89|0.954
73989705|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|0.59||||0.584|TWO_SIDED|95.0|-1.53|2.7|||ANCOVA|||||2.70|-1.53|0.584
73989706|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|0.53||||0.623|TWO_SIDED|95.0|-1.59|2.65|||ANCOVA|||Week 12||2.65|-1.59|0.623
73989707|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|1.39||||0.256|TWO_SIDED|95.0|-1.02|3.79|||ANCOVA|||Follow-up||3.79|-1.02|0.256
73989708|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|1.41||||0.258|TWO_SIDED|95.0|-1.04|3.86|||ANCOVA|||Follow-up||3.86|-1.04|0.258
73989709|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|4.59|||<|0.001|TWO_SIDED|95.0|1.93|7.25|||ANCOVA|||Follow-up||7.25|1.93|<0.001
73989710|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|0.02||||0.988|TWO_SIDED|95.0|-2.47|2.51|||ANCOVA|||Follow-up||2.51|-2.47|0.988
73989711|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|3.2||||0.02|TWO_SIDED|95.0|0.51|5.9|||ANCOVA|||Follow-up||5.90|0.51|0.020
73989712|NCT03305809|147525835|SUPERIORITY||Mean Difference (Net)|3.18||||0.022|TWO_SIDED|95.0|0.46|5.91|||ANCOVA|||Follow-up||5.91|0.46|0.022
73989713|NCT00816556|147525837|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||Dryness severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.42
73989714|NCT00816556|147525837|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Dryness bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.22
73989715|NCT00816556|147525837|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANOVA|||Itching severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.37
73989716|NCT00816556|147525837|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANOVA|||Itching bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.27
73989717|NCT00816556|147525837|SUPERIORITY_OR_OTHER|||||||0.46|||||||ANOVA|||Burning severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.46
73989718|NCT00816556|147525837|SUPERIORITY_OR_OTHER|||||||0.67|||||||ANOVA|||Burning bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.67
73989719|NCT00816556|147525838|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.||||0.33
73989720|NCT00816556|147525838|SUPERIORITY_OR_OTHER|||||||0.99|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.99
73989721|NCT00816556|147525838|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.58
73989722|NCT00816556|147525839|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.||||0.007
73989723|NCT00816556|147525839|SUPERIORITY_OR_OTHER|||||||0.32|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.32
73989724|NCT00816556|147525839|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.02
73989725|NCT03546816|147525868|SUPERIORITY|||||||0.229||||||P-value from a Cochran-Mantel-Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.229
73989726|NCT03546816|147525869|SUPERIORITY|||||||0.013||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.013
73989727|NCT03546816|147525870|SUPERIORITY|||||||0.236||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.236
73989728|NCT03546816|147525871|SUPERIORITY|||||||0.083||||||P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.083
73989729|NCT03546816|147525871|SUPERIORITY|||||||0.049||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.049
73989730|NCT03546816|147525871|SUPERIORITY|||||||0.081||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 6||||0.081
73989731|NCT03546816|147525871|SUPERIORITY|||||||0.157||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.157
73989732|NCT03546816|147525872|SUPERIORITY|||||||0.151||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 2||||0.151
73989733|NCT03546816|147525872|SUPERIORITY|||||||0.052||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 4||||0.052
73989734|NCT03546816|147525872|SUPERIORITY|||||||0.175||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 10||||0.175
73989735|NCT03546816|147525873|SUPERIORITY|||||||0.475||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.475
73989736|NCT03546816|147525873|SUPERIORITY|||||||0.02||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.020
73989737|NCT03546816|147525873|SUPERIORITY|||||||0.492||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.492
73989738|NCT03546816|147525874|SUPERIORITY|||||||0.175||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.175
73989739|NCT03546816|147525874|SUPERIORITY|||||||0.169||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.169
73989740|NCT03546816|147525874|SUPERIORITY|||||||0.516||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.516
73989741|NCT03546816|147525875|SUPERIORITY|||||||0.814||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.814
73989742|NCT03546816|147525876|SUPERIORITY|||||||0.113||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.113
73989743|NCT01161446|147525878|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73989744|NCT01161446|147525879|NON_INFERIORITY|Non-inferiority bound: Self-testing was to be considered non-inferior to standard testing if the upper bound of the 95% confidence interval for the odds ratio fell below 2.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.61|1.9|||Regression, Logistic|Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.|The home testing arm represents the numerator and the standard testing arm the denominator.|||1.90|0.61|
73989745|NCT01161446|147525880|NON_INFERIORITY|Home testing was to be considered non-inferior to standard testing with respect to STI prevalence if the upper bound of the 95% confidence interval for the difference between the two arms (home - standard) fell below 10%.|Difference in proportions|-0.068|||||TWO_SIDED|95.0|-0.16|0.016||||||||0.016|-0.16|
73989746|NCT01161446|147525881|NON_INFERIORITY|Self-testing was to be considered non-inferior with respect to the number of reported male CAI partners if the upper bound of the 95% CI for the fold-difference in the number of partners between the two arms (self ÷ standard testing) fell below 2.|Incidence Rate Ratio|0.92|||||TWO_SIDED|95.0|0.64|1.33|||Poisson regression|Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.|The home testing arm represents the numerator and the standard testing arm the denominator.|||1.33|0.64|
73989747|NCT01777126|147525882|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.0|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home. Preliminary data from our institution showed that all patients received parenteral nutrition very early post-surgery and were discharged after a mean of 19.3 ± 5.6 days. Therefore, the primary objective by implementing the ONP was to reduce the length of stay with 3 days.||||<0.001
74089936|NCT02312713|147732645|SUPERIORITY||Mean Difference (Final Values)|-2.47||||0.03|TWO_SIDED|95.0|-4.67|-0.26|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||-0.26|-4.67|0.03
74089937|NCT02312713|147732645|SUPERIORITY||Mean Difference (Final Values)|-2.43||||0.01|TWO_SIDED|95.0|-4.31|-0.55|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||-0.55|-4.31|0.01
74089938|NCT02312713|147732645|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.39|TWO_SIDED|95.0|-3.24|1.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||1.27|-3.24|0.39
74089939|NCT02312713|147732645|SUPERIORITY||Mean Difference (Final Values)|-1.65||||0.1|TWO_SIDED|95.0|-3.58|0.29|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.29|-3.58|0.1
73989748|NCT01777126|147525885|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0|||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using the Wilcoxon rank sum test. The result was considered statistically significant if p-values were \< 0.05.||||<0.01
73989749|NCT01777126|147525886|SUPERIORITY_OR_OTHER||proportion|||||0.487||95.0|||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square and Fisher's Exact Test. Results were considered statistically significant if p-values were \< 0.05.||||0.487
73989750|NCT01777126|147525887|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.302|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.302
73989751|NCT01777126|147525888|SUPERIORITY_OR_OTHER||Proportion|||||0.117|TWO_SIDED|95.0|||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Fisher's Exact Test. The result was considered statistically significant if p-values were \< 0.05.||||0.117
73989752|NCT01777126|147525889|SUPERIORITY_OR_OTHER||Proportion|||||0.049||95.0|||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were \< 0.05.||||0.049
73989753|NCT01777126|147525890|SUPERIORITY_OR_OTHER||proportion|||||0.698||95.0|||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were \< 0.05.||||0.698
73989754|NCT01660256|147525891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73989755|NCT01660256|147525892|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73989756|NCT00551135|147525935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0668|TWO_SIDED|||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0668
73989757|NCT00551135|147525935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0334|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS (least squares) means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0334
74035098|NCT03725202|147622573|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.8|||=|0.2722|TWO_SIDED|95.0|0.6|1.2|||Poisson regression model|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.2|0.6|=0.2722
74035099|NCT03725202|147622574|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.38|=|0.0036|TWO_SIDED|95.0|1.33|6.76|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib -Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.76|1.33|=0.0036
74089940|NCT02312713|147732645|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.48||||0.11|TWO_SIDED|95.0|-0.33|3.29|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.29|-0.33|0.11
73875938|NCT02831764|147293934|OTHER||Mean Difference (Net)|6.9|||||TWO_SIDED|95.0|-22.7|36.6|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||36.6|-22.7|
73989758|NCT00551135|147525935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8003|TWO_SIDED|||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8003
73989759|NCT00551135|147525935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8003|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8003
73989760|NCT00551135|147525935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6932|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6932
73989761|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4471|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4471
73989762|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7248|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7248
73989763|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7556|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7556
73989764|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0571|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0571
73989765|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0197|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0197
73989766|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2398|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2398
73989767|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0709|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0709
73989768|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9902|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9902
73989769|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0018
73989770|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4639|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4639
73989771|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4845|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4845
73989772|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1641|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1641
73989773|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1025|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1025
74039679|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.17||||0.5599|TWO_SIDED|95.0|0.69|1.99|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.99|0.69|0.5599
73875939|NCT02831764|147293934|OTHER||Mean Difference (Net)|13.2|||||TWO_SIDED|95.0|-46.8|73.2|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||73.2|-46.8|
73875940|NCT02831764|147293934|OTHER||Mean Difference (Net)|57.7|||||TWO_SIDED|95.0|-37.2|152.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||152.5|-37.2|
73989774|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5615|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5615
73989775|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2904|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2904
73989776|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6017|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6017
73989777|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8549|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8549
73989778|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3386|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3386
74039680|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.71||||0.0202|TWO_SIDED|95.0|1.09|2.68|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.68|1.09|0.0202
74089941|NCT02312713|147732645|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.33|TWO_SIDED|95.0|-0.8|2.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||2.37|-0.8|0.33
73989779|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7070
73989780|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5244|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5244
73989781|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4245|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4245
73989782|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8624|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8624
73989783|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7552|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7552
73989784|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7329|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7329
73989785|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3053|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3053
73989786|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5290
73989787|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7951|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7951
73989788|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.715|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7150
73989789|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4566|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4566
74089942|NCT02312713|147732646|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.06|TWO_SIDED|95.0|-1.62|0.04|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.04|-1.62|0.06
73989790|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7750
73989791|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9241|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9241
73989792|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8994|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8994
73989793|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2088|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2088
73989794|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2152|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2152
73989795|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7662|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7662
74089943|NCT02312713|147732646|SUPERIORITY||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.77|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.77|-0.77|1.00
74089944|NCT02312713|147732646|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.31|TWO_SIDED|95.0|-1.29|0.41|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.41|-1.29|0.31
73989796|NCT00551135|147525936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7579|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7579
73989797|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6896|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6896
73875941|NCT02831764|147293934|OTHER||Mean Difference (Net)|4.1|||||TWO_SIDED|95.0|-23.5|31.7|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||31.7|-23.5|
73989798|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1934|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1934
73989799|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6034|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6034
73989800|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7992|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7992
73989801|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4770
73989802|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8730
74035100|NCT03725202|147622574|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|1.63|=|0.0338|TWO_SIDED|95.0|0.27|6.7|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib -Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.70|0.27|=0.0338
74089945|NCT02312713|147732646|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.58|TWO_SIDED|95.0|-1.01|0.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.57|-1.01|0.58
73875942|NCT02831764|147293934|OTHER||Mean Difference (Net)|32.5|||||TWO_SIDED|95.0|-2.7|67.7|||||Age Group-1,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||67.7|-2.7|
73989803|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2000
73989804|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5059|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5059
73989805|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0348|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0348
73989806|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3815|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3815
73989807|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4716|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4716
73875943|NCT02831764|147293934|OTHER||Mean Difference (Net)|-31.5|||||TWO_SIDED|95.0|-77.1|14.2|||||Age Group-1,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||14.2|-77.1|
73875944|NCT02831764|147293934|OTHER||Mean Difference (Net)|5.2|||||TWO_SIDED|95.0|-81.4|91.8|||||Age Group-1,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||91.8|-81.4|
73989808|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1063|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1063
73989809|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3884|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3884
73989810|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3787|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3787
73989811|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2537|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2537
73989812|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0952|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0952
73989813|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7725|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7725
73989814|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.066|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0660
73989815|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3657|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3657
73989816|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7717|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7717
73989817|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5849|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5849
73989818|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9580
74035101|NCT03725202|147622575|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|2.7325|STANDARD_ERROR_OF_MEAN|2.9635|=|0.3573|TWO_SIDED|95.0|-3.102|8.567|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib -Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||8.5670|-3.1020|=0.3573
73989819|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9884|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9884
73989820|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6743|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6743
73989821|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2689|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2689
73989822|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6907|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6907
73989823|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4798|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4798
73989824|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5609
73989825|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9834|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9834
73989826|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8339|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8339
73989827|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8730
73875945|NCT02831764|147293934|OTHER||Mean Difference (Net)|8.6|||||TWO_SIDED|95.0|-19.4|36.5|||||Age Group-2, \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||36.5|-19.4|
73875946|NCT02831764|147293934|OTHER||Mean Difference (Net)|4.5|||||TWO_SIDED|95.0|-82.3|91.3|||||Age Group-2, \>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||91.3|-82.3|
73875947|NCT02831764|147293934|OTHER||Mean Difference (Net)|-27.3|||||TWO_SIDED|95.0|-100.8|46.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.1|-100.8|
73875948|NCT02831764|147293934|OTHER||Mean Difference (Net)|12.8|||||TWO_SIDED|95.0|-15.7|41.2|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||41.2|-15.7|
73875949|NCT02831764|147293934|OTHER||Mean Difference (Net)|11.3|||||TWO_SIDED|95.0|-20.4|43.1|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||43.1|-20.4|
73989828|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6327|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6327
73989829|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3986|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3986
73989830|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.637|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6370
73989831|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9869|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9869
73989832|NCT00551135|147525937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.755|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7550
73989833|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2912|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2912
73989834|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3723|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3723
73989835|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6116|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6116
73989836|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0835|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0835
73989837|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1497|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1497
73989838|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.395|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3950
73989839|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5892|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5892
73875950|NCT02831764|147293934|OTHER||Mean Difference (Net)|-37.8|||||TWO_SIDED|95.0|-119.6|44.0|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||44.0|-119.6|
73875951|NCT02831764|147293934|OTHER||Mean Difference (Net)|15.6|||||TWO_SIDED|95.0|-74.4|105.7|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||105.7|-74.4|
73875952|NCT02831764|147293934|OTHER||Mean Difference (Net)|37.6|||||TWO_SIDED|95.0|-45.4|120.5|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||120.5|-45.4|
73875953|NCT02831764|147293935|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-34.1|35.0|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||35.0|-34.1|
73875954|NCT02831764|147293935|OTHER||Mean Difference (Net)|14.7|||||TWO_SIDED|95.0|-55.6|84.9|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||84.9|-55.6|
73989840|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6143|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6143
73989841|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0104
73989842|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5666|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5666
73989843|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9008|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9008
73989844|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0967|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0967
73989845|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8353|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8353
73989846|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.453|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4530
73989847|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7297|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7297
73989848|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0692
73989849|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6333|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6333
73989850|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0325|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0325
73989851|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5788|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5788
73989852|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9224|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9224
73989853|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5527|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5527
73989854|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2624|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2624
73989855|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3263|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3263
73989856|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3746|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3746
73989857|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0050
73989858|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0493|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0493
73989859|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0773|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0773
73989860|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0547|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0547
74035102|NCT03725202|147622575|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|5.4216|STANDARD_ERROR_OF_MEAN|3.4785|=|0.1203|TWO_SIDED|95.0|-1.4269|12.2701|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib -Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||12.2701|-1.4269|=0.1203
73989861|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1976|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1976
74035103|NCT03725202|147622576|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|1.1|||=|0.4371|TWO_SIDED|95.0|0.8|1.6|||Poisson regression model|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.6|0.8|=0.4371
74035104|NCT03725202|147622576|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.9|||=|0.7749|TWO_SIDED|95.0|0.6|1.4|||Poisson regression model|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.4|0.6|=0.7749
74089946|NCT02312713|147732646|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.35||||0.32|TWO_SIDED|95.0|-0.33|1.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||1.03|-0.33|0.32
74089947|NCT02312713|147732646|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.22||||0.51|TWO_SIDED|95.0|-0.86|0.43|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.43|-0.86|0.51
74089948|NCT02312713|147732647|SUPERIORITY||Mean Difference (Final Values)|6.95||||0.48|TWO_SIDED|95.0|-12.31|26.22|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||26.22|-12.31|0.48
74089949|NCT02312713|147732647|SUPERIORITY||Mean Difference (Final Values)|7.11||||0.41|TWO_SIDED|95.0|-9.69|23.91|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||23.91|-9.69|0.41
74089950|NCT02312713|147732647|SUPERIORITY||Mean Difference (Final Values)|-6.82||||0.5|TWO_SIDED|95.0|-26.55|12.91|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||12.91|-26.55|0.50
74089951|NCT02312713|147732647|SUPERIORITY||Mean Difference (Final Values)|7.02||||0.43|TWO_SIDED|95.0|-10.31|24.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||24.35|-10.31|0.43
74089952|NCT02312713|147732647|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-13.77||||0.09|TWO_SIDED|95.0|-29.73|2.19|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||2.19|-29.73|0.09
74089953|NCT02312713|147732647|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.09||||0.99|TWO_SIDED|95.0|-14.41|14.23|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||14.23|-14.41|0.99
74035105|NCT01328249|147622580|OTHER|Fisher's Exact test||||||0.4422||||||Null hypothesis: The feasibility rates of Cohort 1 and Cohort 2 are same.|Fisher Exact|Exploratory analysis comparing primary feasibilities between 2 cohorts, based on Fisher's Exact test.||||||0.4422
74089954|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|1.36||||0.04|TWO_SIDED|95.0|0.05|2.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Strengthening Exercises||2.66|0.05|0.04
74089955|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|1.21||||0.09|TWO_SIDED|95.0|-0.18|2.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Strengthening Exercises.||2.6|-0.18|0.09
73989862|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3832|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3832
73989863|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4216|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4216
73989864|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5852|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5852
73989865|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7336|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7336
73989866|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1647|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1647
73989867|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2813|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2813
73989868|NCT00551135|147525938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8423|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8423
73989869|NCT00551135|147525939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.397|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.3970
73989870|NCT00551135|147525939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.764|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.7640
74035106|NCT02330549|147622585|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.2286|STANDARD_ERROR_OF_MEAN|0.195||0.2483|TWO_SIDED|95.0|-0.62|0.17||An analysis of covariance (ANCOVA) model that included treatment and presence or absence of nonalcoholic steatohepatitis (NASH) as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12||0.17|-0.62|0.2483
73989871|NCT00551135|147525939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5064|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.5064
73989872|NCT00551135|147525939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1318|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1318
73989873|NCT00551135|147525939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9367
73989874|NCT00551135|147525939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1259|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1259
74035107|NCT02330549|147622585|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.4113|STANDARD_ERROR_OF_MEAN|0.205||0.053|TWO_SIDED|95.0|-0.83|0.01||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change form Baseline to Week 24||0.01|-0.83|0.053
73989875|NCT00551135|147525939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1812|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1812
73989876|NCT00551135|147525939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9600
73989877|NCT00551135|147525939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.105|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1050
73989878|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2818|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2818
73989879|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8631|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8631
73989880|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5074|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5074
73989881|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0401|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0401
73989882|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5509|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5509
73989883|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0004
73989884|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7070
73989885|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.384|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3840
73989886|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2732|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2732
73989887|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4418|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4418
73989888|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8379|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8379
73989889|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5944|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5944
73989890|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8139|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8139
73989891|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9709|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9709
73989892|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9666|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9666
73989893|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3204|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3204
73989894|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0869|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0869
73875955|NCT02831764|147293935|OTHER||Mean Difference (Net)|26.5|||||TWO_SIDED|95.0|-87.3|140.3|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||140.3|-87.3|
73875956|NCT02831764|147293935|OTHER||Mean Difference (Net)|2.8|||||TWO_SIDED|95.0|-29.4|35.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||35.1|-29.4|
73875957|NCT02831764|147293935|OTHER||Mean Difference (Net)|8.3|||||TWO_SIDED|95.0|-32.5|49.1|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||49.1|-32.5|
73875958|NCT02831764|147293935|OTHER||Mean Difference (Net)|-13.3|||||TWO_SIDED|95.0|-67.6|41.1|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||41.1|-67.6|
73875959|NCT02831764|147293935|OTHER||Mean Difference (Net)|32.7|||||TWO_SIDED|95.0|-68.5|133.9|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||133.9|-68.5|
73989895|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9386|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9386
73989896|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4352|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4352
73875960|NCT02831764|147293935|OTHER||Mean Difference (Net)|5.1|||||TWO_SIDED|95.0|-80.7|90.8|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||90.8|-80.7|
73875961|NCT02831764|147293935|OTHER||Mean Difference (Net)|2.1|||||TWO_SIDED|95.0|-31.1|35.3|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||35.3|-31.1|
73875962|NCT02831764|147293935|OTHER||Mean Difference (Net)|13.7|||||TWO_SIDED|95.0|-23.2|50.6|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||50.6|-23.2|
73989897|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4522|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4522
74035108|NCT02330549|147622586|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-1.505|STANDARD_ERROR_OF_MEAN|2.369||0.5297|TWO_SIDED|95.0|-6.33|3.32||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12||3.32|-6.33|0.5297
73875963|NCT02831764|147293935|OTHER||Mean Difference (Net)|-57.4|||||TWO_SIDED|95.0|-155.3|40.4|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||40.4|-155.3|
73875964|NCT02831764|147293935|OTHER||Mean Difference (Net)|-40.1|||||TWO_SIDED|95.0|-144.2|64.0|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||64.0|-144.2|
73875965|NCT02831764|147293935|OTHER||Mean Difference (Net)|33.1|||||TWO_SIDED|95.0|-63.3|129.6|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||129.6|-63.3|
73875966|NCT02831764|147293936|OTHER||Mean Difference (Net)|9.1|||||TWO_SIDED|95.0|-31.1|49.2|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||49.2|-31.1|
73875967|NCT02831764|147293936|OTHER||Mean Difference (Net)|-16.6|||||TWO_SIDED|95.0|-98.9|65.8|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||65.8|-98.9|
73875968|NCT02831764|147293936|OTHER||Mean Difference (Net)|56.0|||||TWO_SIDED|95.0|-77.2|189.1|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||189.1|-77.2|
73875969|NCT02831764|147293936|OTHER||Mean Difference (Net)|2.4|||||TWO_SIDED|95.0|-35.2|39.9|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||39.9|-35.2|
73989898|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6606|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6606
74039681|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0335|TWO_SIDED|95.0|1.04|2.57|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.57|1.04|0.0335
73875970|NCT02831764|147293936|OTHER||Mean Difference (Net)|25.8|||||TWO_SIDED|95.0|-22.3|74.0|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||74.0|-22.3|
73989899|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1733|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1733
73989900|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8788|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8788
73989901|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8474|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8474
73989902|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2938|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2938
73875971|NCT02831764|147293936|OTHER||Mean Difference (Net)|-36.4|||||TWO_SIDED|95.0|-98.6|25.8|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||25.8|-98.6|
73875972|NCT02831764|147293936|OTHER||Mean Difference (Net)|24.1|||||TWO_SIDED|95.0|-89.0|137.2|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||137.2|-89.0|
73989903|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7602|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7602
73989904|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6881|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6881
73989905|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7883|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7883
73989906|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5374|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5374
73989907|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9774|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9774
73875973|NCT02831764|147293936|OTHER||Mean Difference (Net)|-26.9|||||TWO_SIDED|95.0|-125.9|72.2|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||72.2|-125.9|
73875974|NCT02831764|147293936|OTHER||Mean Difference (Net)|8.1|||||TWO_SIDED|95.0|-30.3|46.5|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.5|-30.3|
73875975|NCT02831764|147293936|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|-39.4|46.3|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||46.3|-39.4|
73989908|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3082|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3082
73989909|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4373|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4373
73989910|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.654|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6540
73989911|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0002
73989912|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0696|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0696
74035109|NCT02330549|147622586|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|3.2146|STANDARD_ERROR_OF_MEAN|2.757||0.2522|TWO_SIDED|95.0|-2.4|8.83||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 24||8.83|-2.4|0.2522
73875976|NCT02831764|147293936|OTHER||Mean Difference (Net)|-121.2|||||TWO_SIDED|95.0|-237.2|-5.1|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||-5.1|-237.2|
73875977|NCT02831764|147293936|OTHER||Mean Difference (Net)|13.1|||||TWO_SIDED|95.0|-106.4|132.6|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||132.6|-106.4|
73875978|NCT02831764|147293936|OTHER||Mean Difference (Net)|114.3|||||TWO_SIDED|95.0|4.6|224.0|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||224.0|4.6|
73989913|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0029|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0029
73989914|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3695|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3695
73989915|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9346|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9346
73989916|NCT00551135|147525940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9631|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9631
73989917|NCT00551135|147525941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9025|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9025
73875979|NCT02831764|147293937|OTHER||Mean Difference (Net)|-0.0019||||0.759|TWO_SIDED|95.0|-0.0137|0.01|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0100|-0.0137|0.759
73875980|NCT02831764|147293937|OTHER||Mean Difference (Net)|0.0003||||0.943|TWO_SIDED|95.0|-0.0088|0.0095|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0095|-0.0088|0.943
73875981|NCT02831764|147293937|OTHER||Mean Difference (Net)|-0.0019||||0.703|TWO_SIDED|95.0|-0.0117|0.0079|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0079|-0.0117|0.703
73989918|NCT00551135|147525941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5652|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.5652
73989919|NCT00551135|147525941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.792|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.7920
73989920|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6679|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6679
73989921|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7308|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7308
74035110|NCT00495495|147622657|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.1126|ONE_SIDED||||||McNemar|||"Null hypothesis: there is no difference between the HealOzone and Placebo devices in the proportion of teeth with lesion progression after 1 year.~Power calculation: the study was sized to have 90% power to detect a 15% difference between treatments in the percentage of teeth with lesion progression at one year (i.e., assuming 45% for the lesions treated with the Placebo device and 30% for the lesions treated with the HealOzone device) with a sample size of 258 subjects completing the study."||||0.1126
74035111|NCT00495495|147622658|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.08||||0.9777|ONE_SIDED||||||McNemar|||||||.9777
73875982|NCT02831764|147293938|OTHER||Mean Difference (Net)|-0.0003||||0.957|TWO_SIDED|95.0|-0.011|0.0104|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0104|-0.0110|0.957
73875983|NCT02831764|147293939|OTHER||Mean Difference (Net)|0.0079||||0.162|TWO_SIDED|95.0|-0.0032|0.0189|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0189|-0.0032|0.162
73875984|NCT02831764|147293940|OTHER||Mean Difference (Net)|-1.3||||0.045|TWO_SIDED|95.0|-2.6|0.0|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0|-2.6|0.045
73989922|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6781|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6781
73989923|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0930
73989924|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3751|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3751
74035112|NCT00495495|147622659|SUPERIORITY_OR_OTHER|||||||0.0416|ONE_SIDED|95.0|||||McNemar|||||||.0416
74035113|NCT00495495|147622660|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.6585|ONE_SIDED|95.0|||||McNemar|||||||0.6585
74035114|NCT00495495|147622661|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.7666|ONE_SIDED|95.0|||||McNemar|||||||.7666
73989925|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0111|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0111
73989926|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6811|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6811
73989927|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7426|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7426
73989928|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1619|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1619
73875985|NCT02831764|147293940|OTHER||Mean Difference (Net)|-0.6||||0.358|TWO_SIDED|95.0|-1.9|0.7|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.7|-1.9|0.358
74035115|NCT01670656|147622679|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||<|0.001|TWO_SIDED|95.0|-1.0|-0.2|||cLDA|||||-0.2|-1.0|< 0.001
73875986|NCT02831764|147293940|OTHER||Mean Difference (Net)|-0.6||||0.328|TWO_SIDED|95.0|-1.9|0.6|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.6|-1.9|0.328
73875987|NCT02831764|147293941|OTHER||Mean Difference (Net)|-0.7||||0.318|TWO_SIDED|95.0|-2.1|0.7|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.7|-2.1|0.318
73875988|NCT02831764|147293942|OTHER||Mean Difference (Net)|0.3||||0.674|TWO_SIDED|95.0|-1.0|1.6|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||1.6|-1.0|0.674
73989929|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1132|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1132
73989930|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9822|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9822
73989931|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1883|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1883
74035116|NCT01670656|147622679|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||cLDA|||||-0.2|-0.9|< 0.001
74035117|NCT01670656|147622679|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||cLDA|||||-0.4|-1.1|< 0.001
74035118|NCT01670656|147622679|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||cLDA|||||-0.2|-0.9|< 0.001
74035119|NCT01670656|147622680|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.7|||=|0.002|TWO_SIDED|95.0|-3.0|-0.4|||cLDA|||||-0.4|-3.0|= 0.002
74035120|NCT01670656|147622680|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.9|||<|0.001|TWO_SIDED|95.0|-3.1|-0.6|||cLDA|||||-0.6|-3.1|< 0.001
73989932|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9391|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9391
73989933|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9664|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9664
73989934|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0747|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0747
73989935|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9681|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9681
73989936|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3246|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3246
73989937|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7984|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7984
73989938|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8581|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8581
74035121|NCT01670656|147622680|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.6|||=|0.003|TWO_SIDED|95.0|-2.9|-0.3|||cLDA|||||-0.3|-2.9|= 0.003
74035122|NCT01670656|147622680|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.2|||=|0.024|TWO_SIDED|95.0|-2.5|0.1|||cLDA|||||0.1|-2.5|= 0.024
74035123|NCT01670656|147622681|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.6|||=|0.026|TWO_SIDED|95.0|-3.4|0.2|||cLDA|||||0.2|-3.4|= 0.026
73875989|NCT01584232|147293970|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) was \<0.4%, then LY2189265 was declared non-inferior to insulin glargine. If the upper limit of the 95% CI was \<0.0%, then LY2189265 was declared superior to insulin glargine.|LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.67|-0.41||P-value is from the pairwise comparison of LS means using a mixed effects model with repeated measurements (MMRM).|Mixed Models Analysis|||Approximately 360 participants were to be randomized in a 1:1 ratio to LY2189265 or insulin glargine (IG). Assuming no difference in HbA1c change from baseline at Week 26 between LY2189265 and IG, this sample size would provide approximately 90% power to confirm non-inferiority of LY2189265 to IG. This computation was based on a non-inferiority margin of 0.4% with a standard deviation of 1.1%, a 1-sided alpha level of 0.025, and an 11% dropout rate between randomization and Week 26.||-0.41|-0.67|<0.001
73989939|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9677|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9677
73989940|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7104|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7104
73989941|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8978|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8978
73989942|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.626|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6260
73875990|NCT01584232|147293971|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c \<=6.5%.|Regression, Logistic|||||||<0.001
73989943|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4047|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4047
73989944|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4461|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4461
73989945|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9099|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9099
74035124|NCT01670656|147622681|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.5|||=|0.036|TWO_SIDED|95.0|-3.3|0.2|||cLDA|||||0.2|-3.3|= 0.036
74035125|NCT01670656|147622681|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-2.3|||=|0.002|TWO_SIDED|95.0|-4.1|-0.5|||cLDA|||||-0.5|-4.1|= 0.002
73875991|NCT01584232|147293971|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c \<7%.|Regression, Logistic|||||||<0.001
73875992|NCT01584232|147293972|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5||||0.183|TWO_SIDED|95.0|-1.7|8.7|||Mixed Models Analysis|||||8.7|-1.7|0.183
74035126|NCT01670656|147622681|SUPERIORITY_OR_OTHER_LEGACY||Diffference in Least Squares Means|-1.2|||=|0.1|TWO_SIDED|95.0|-3.0|0.6|||cLDA|||||0.6|-3.0|= 0.1
73875993|NCT01584232|147293973|SUPERIORITY_OR_OTHER||LS Mean Difference|5.16||||0.022|TWO_SIDED|95.0|0.76|9.56||Treatment comparison for pre-morning meal.|ANCOVA|||||9.56|0.76|0.022
74035127|NCT01670656|147622682|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.1|||=|0.447|TWO_SIDED|95.0|-0.6|0.3|||cLDA|||||0.3|-0.6|= 0.447
74035128|NCT01670656|147622682|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||=|0.003|TWO_SIDED|95.0|-1.0|-0.1|||cLDA|||||-0.1|-1.0|= 0.003
73875994|NCT01584232|147293973|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.4||||0.003|TWO_SIDED|95.0|-22.28|-4.52||Treatment comparison for 2 hours post-morning meal.|ANCOVA|||||-4.52|-22.28|0.003
73875995|NCT01584232|147293973|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.22||||0.025|TWO_SIDED|95.0|-15.37|-1.06||Treatment comparison for pre-midday meal.|ANCOVA|||||-1.06|-15.37|0.025
74035129|NCT01670656|147622682|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||=|0.003|TWO_SIDED|95.0|-1.0|-0.1|||cLDA|||||-0.1|-1.0|= 0.003
74035130|NCT01670656|147622682|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.3|||=|0.156|TWO_SIDED|95.0|-0.7|0.2|||cLDA|||||0.2|-0.7|= 0.156
74035131|NCT03583372|147622693|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.4|||||TWO_SIDED|95.0|-2.9|-2.0||||||||-2.0|-2.9|
73875996|NCT01584232|147293973|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.22|||<|0.001|TWO_SIDED|95.0|-31.92|-14.51||Treatment comparison for 2 hours post-midday meal.|ANCOVA|||||-14.51|-31.92|<0.001
73989946|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8805|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8805
73989947|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2348|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2348
73989948|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4445|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4445
73989949|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8849|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8849
73989950|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2796|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2796
73875997|NCT01584232|147293973|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.63|||<|0.001|TWO_SIDED|95.0|-21.03|-6.24||Treatment comparison for pre-evening meal.|ANCOVA|||||-6.24|-21.03|<0.001
73875998|NCT01584232|147293973|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.13|||<|0.001|TWO_SIDED|95.0|-39.26|-23.0||Treatment comparison for 2 hours post-evening meal.|ANCOVA|||||-23.00|-39.26|<0.001
73989951|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5225|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5225
73989952|NCT00551135|147525942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7015|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7015
73989953|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3332|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3332
73989954|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0933|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0933
73989955|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0031
73989956|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9451|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9451
73989957|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7312|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7312
73989958|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0348|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0348
73989959|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8936|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8936
73989960|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7672|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7672
73989961|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4285|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4285
74035132|NCT03583372|147622693|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.0|||||TWO_SIDED|95.0|-2.5|-1.5||||||||-1.5|-2.5|
74035133|NCT03583372|147622694|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.2|||||TWO_SIDED|95.0|-2.5|-1.9||||||||-1.9|-2.5|
73875999|NCT01584232|147293973|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.73|||<|0.001|TWO_SIDED|95.0|-31.68|-15.79||Treatment comparison for bedtime.|ANCOVA|||||-15.79|-31.68|<0.001
73876000|NCT01584232|147293973|SUPERIORITY_OR_OTHER||LS Mean Difference|6.21||||0.005|TWO_SIDED|95.0|1.92|10.5||Treatment comparison for second pre-morning meal.|ANCOVA|||||10.50|1.92|0.005
73876001|NCT01584232|147293974|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.89|-0.94|||Mixed Models Analysis|||||-0.94|-1.89|<0.001
73876002|NCT01584232|147293975|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
73989962|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0785|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0785
73989963|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3348|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3348
73989964|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1366|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1366
73989965|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3338|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3338
73989966|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4460
73989967|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1078|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1078
73989968|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8273|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8273
73989969|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6140
73989970|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1684|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1684
73989971|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1285|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1285
73989972|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.264|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2640
74035134|NCT03583372|147622694|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-1.7|||||TWO_SIDED|95.0|-2.0|-1.3||||||||-1.3|-2.0|
74035135|NCT03583372|147622695|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-3.4|||||TWO_SIDED|95.0|-4.0|-2.7||||||||-2.7|-4.0|
74035136|NCT03583372|147622695|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-3.2|||||TWO_SIDED|95.0|-4.0|-2.5||||||||-2.5|-4.0|
74035137|NCT03583372|147622696|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.5|||||TWO_SIDED|95.0|-2.8|-2.2||||||||-2.2|-2.8|
74035138|NCT03583372|147622696|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-1.9|||||TWO_SIDED|95.0|-2.3|-1.6||||||||-1.6|-2.3|
73989973|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8956|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8956
73989974|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0058|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0058
73989975|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9929|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9929
73989976|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0473|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0473
73989977|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2426|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2426
74035139|NCT01151046|147622698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.003|TWO_SIDED|95.0|0.11|0.63|||Log Rank|||||0.63|0.11|0.003
74035140|NCT01151046|147622698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.41||||0.349|TWO_SIDED|95.0|0.69|2.88|||Log Rank|||||2.88|0.69|0.349
74035141|NCT05439460|147622704|OTHER|||||||0.9|||||||t-test, 2 sided|||Change in phenylephrine group||||0.9
74035142|NCT05439460|147622704|OTHER|||||||0.3||||||A p-value of \<0.05 would be considered statistically significant.|t-test, 2 sided|||Change in arginine vasopressin group||||0.3
73876003|NCT01307319|147293976|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.63|||<|0.001|TWO_SIDED|95.0|-1.0|-0.3||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.3|-1.0|<0.001
73876004|NCT01307319|147293976|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.73|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
73989978|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3478|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3478
74035143|NCT05439460|147622704|OTHER|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|t-test, 2 sided|||Change in epinephrine group||||1
74035144|NCT01980706|147622735|SUPERIORITY||Mean Difference (Net)|4.16||||0.018|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.018
74035145|NCT01980706|147622736|SUPERIORITY||Mean Difference (Net)|3.68||||0.028|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.028
74035146|NCT01980706|147622737|SUPERIORITY||Mean Difference (Net)|0.65||||0.52|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.52
74035147|NCT01980706|147622738|SUPERIORITY||Mean Difference (Net)|0.84||||0.43|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.43
73989979|NCT00551135|147525946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1694|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1694
73989980|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0630
73989981|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0347|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0347
73989982|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0024
73989983|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0767|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0767
73989984|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1327|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1327
74035148|NCT01980706|147622739|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.6|TWO_SIDED|||||Threshold for significance is \<.05|ANCOVA|Adjusted for baseline|Estimated parameter is the overall treatment main effect F statistic from the fitted ANCOVA model assessing the null hypothesis of equal values across the three groups|||||0.60
74035149|NCT01980706|147622740|SUPERIORITY||Table probability for Fisher's Exact|0.002||||0.07|TWO_SIDED|||||Threshold for significance is \<.05|Fisher Exact|||||||0.07
73989985|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0078
73989986|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0694|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0694
73876005|NCT01307319|147293977|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.71|||<|0.001|TWO_SIDED|95.0|-1.1|-0.3||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||The power calculation assumed the standard deviation (SD) for the change from baseline over two weeks in the average of AM and PM reflective TNSS is assumed to be 2.0. Using this standard deviation, 235 subjects per arm provides 90% power to detect a difference of 0.60 in TNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.||-0.3|-1.1|<0.001
73876006|NCT01307319|147293977|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.76|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
73989987|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2173|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2173
73989988|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0193|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0193
73989989|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0673|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0673
73989990|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2629|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2629
73989991|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0388|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0388
73989992|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0651|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0651
73989993|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3242|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3242
73989994|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0345|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0345
74035150|NCT01151579|147622780|NON_INFERIORITY_OR_EQUIVALENCE|A total of at least 400 treatemnts or 65 patients was required to achieve 94% power to determine a 1% change by treatment or a 5% change between groups to be significant at p-value of 0.01 and o.05, respectively.|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.5||0.01|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No difference between groups in heart rate changes from baseline following treatment. Sample size calculation determined a need for at least 400 breathing treatments among 65 patients.||||0.01
73989995|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0487|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0487
73989996|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3384|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3384
74035151|NCT01151579|147622781|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.05|TWO_SIDED|95.0||||Analysis adjusted with Fischer exact chi-square for rare occurrences.|Chi-squared|||Null hypothesis: no difference in incidence of arrhythmias between groups within the total number of breathing treatments.||||0.05
73989997|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0467|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0467
73989998|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0347|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0347
73989999|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3086|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3086
73990000|NCT00551135|147525947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0406|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0406
73990001|NCT00551135|147525948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4177|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4177
73990002|NCT00551135|147525948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4410
73990003|NCT00551135|147525948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.556|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5560
73990004|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4273|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4273
73876007|NCT03629886|147293986|OTHER|The IR (n/T) of incident cervical infection with HPV-16 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|0.15|||||TWO_SIDED|95.0|0.09|0.23||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=1963). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.23|0.09|
73876008|NCT03629886|147293986|OTHER|The IR (n/T) of incident cervical infection with HPV-16 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.88|||||TWO_SIDED|95.0|0.73|1.05||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=1917). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||1.05|0.73|
73876009|NCT03629886|147293986|OTHER|The IR (n/T) of incident cervical infection with HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.09|||||TWO_SIDED|95.0|0.05|0.15||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2356). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.15|0.05|
73990005|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4466|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4466
73990006|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3785
73990007|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5272|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5272
73990008|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4257|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4257
73990009|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1428|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1428
73990010|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2316|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2316
73990011|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3468|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3468
73990012|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5367|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5367
73990013|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0549|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0549
73990014|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1351|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1351
73990015|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9599|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9599
73990016|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4273|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4273
73990017|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4466|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4466
73990018|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3785
74035152|NCT01151579|147622782|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||descriptive|Descriptive statistics (frequency) used to report the number of participants experiencing an event.||To report on the number of events.||||0
73990019|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2869|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2869
73990020|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9905
73990021|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9381|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9381
73990022|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2158|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2158
73990023|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7887|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7887
73990024|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.925|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9250
73990025|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1472|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1472
73990026|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5383|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5383
73990027|NCT00551135|147525949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8869|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8869
73990028|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4024|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.4024
73990029|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9766|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.9766
74035153|NCT02458690|147622783|SUPERIORITY|||||||0.6|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.60
74035154|NCT02458690|147622784|SUPERIORITY||||||<|0.01|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||<0.01
74035155|NCT02458690|147622785|SUPERIORITY|||||||0.81|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.81
74035156|NCT02458690|147622786|SUPERIORITY|||||||0.2|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.20
74035157|NCT02458690|147622787|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.09
73990030|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9975|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.9975
73990031|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9038|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.9038
73990032|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.937|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.9370
73990033|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2134|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.2134
73990034|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.2482
73990035|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.2207
74035158|NCT02458690|147622788|SUPERIORITY|||||||0.23|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.23
74035159|NCT02458690|147622789|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.09
74035160|NCT03807739|147622801|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|1.2471|||||TWO_SIDED|90.0|1.1149|1.3951||||||||1.3951|1.1149|
74035161|NCT03807739|147622801|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|0.9864|||||TWO_SIDED|90.0|0.8531|1.1405||||||||1.1405|0.8531|
74035162|NCT03807739|147622803|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|1.2203|||||TWO_SIDED|90.0|1.1175|1.3327||||||||1.3327|1.1175|
74035163|NCT03807739|147622803|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|0.9947|||||TWO_SIDED|90.0|0.8266|1.1968||||||||1.1968|0.8266|
74039682|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0416|TWO_SIDED|95.0|1.04|6.17|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||6.17|1.04|0.0416
73990036|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.9191
73990037|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0686|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0686
73990038|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0746
73876010|NCT03629886|147293986|OTHER|The IR (n/T) of incident cervical infection with HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.44|||||TWO_SIDED|95.0|0.35|0.56||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2357). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.56|0.35|
73876011|NCT03629886|147293986|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|0.2|||||TWO_SIDED|95.0|0.14|0.27||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2534). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.27|0.14|
73990039|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0512|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0512
73990040|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7118|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.7118
73990041|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9883|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.9883
73990042|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.977|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.9770
73990043|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5457|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.5457
74035164|NCT02371759|147622811|NON_INFERIORITY_OR_EQUIVALENCE|In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group||||<0.05
73990044|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2579|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.2579
73990045|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1232|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.1232
74035165|NCT02371759|147622812|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73990046|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.288|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.2880
73990047|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0894|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.0894
73990048|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1979|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.1979
74035166|NCT02371759|147622828|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73990049|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0686|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.0686
73990050|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.0746
73990051|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4669|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.4669
74035167|NCT02371759|147622829|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
74035168|NCT02371759|147622830|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
74035169|NCT02371759|147622831|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
74035170|NCT02371759|147622832|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73990052|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5533|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.5533
73990053|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1611|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.1611
73990054|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1611|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.1611
73990055|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4793|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.4793
73990056|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3533|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.3533
73990057|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8852|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.8852
73990058|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.3173
73990059|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.3173
73990060|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8864|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.8864
73990061|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8084|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.8084
73990062|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.3173
73990063|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.2207
73990064|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3747|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.3747
73990065|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.145|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.1450
73990066|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2054|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.2054
73990067|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4106|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.4106
73990068|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2199|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.2199
73990069|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2896|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.2896
73990070|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||1.0000
73990071|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||0.3173
73990072|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3943|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||0.3943
73990073|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1703|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.1703
73990074|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0807|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.0807
73990075|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7728|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.7728
74035171|NCT02371759|147622833|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74035172|NCT02371759|147622834|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
74035173|NCT02371759|147622835|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73990076|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.4770
73990077|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3625|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.3625
74035174|NCT00430625|147622836|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.429|STANDARD_ERROR_OF_MEAN|0.324|<|0.0001|TWO_SIDED|95.0|1.717|3.141|||paired t-test|||Primary endpoint was based solely on the 60 U/kg treatment arm||3.141|1.717|<0.0001
74035175|NCT00243230|147622848|SUPERIORITY||VCV 30 mg vs. Placebo|-0.98||||0.0017|TWO_SIDED|95.0|-1.58|-0.37|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.37|-1.58|0.0017
74035176|NCT00243230|147622848|SUPERIORITY||VCV 20 mg vs. Placebo|-0.93||||0.0026||95.0|-1.54|-0.33|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.33|-1.54|0.0026
74035177|NCT00243230|147622849|SUPERIORITY|||||||0.0052|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0052
74089956|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.22|TWO_SIDED|95.0|-0.49|2.19|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Strengthening Exercises.||2.19|-0.49|0.22
74089957|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.06|TWO_SIDED|95.0|-0.08|2.78|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Strengthening Exercises.||2.78|-0.08|0.06
73990078|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0617|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.0617
74089958|NCT02312713|147732648|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.51||||0.36|TWO_SIDED|95.0|-1.6|0.58|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Strength.||0.58|-1.6|0.36
74035178|NCT00243230|147622849|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0190
74035179|NCT00243230|147622850|SUPERIORITY|||||||0.0007|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0007
74035180|NCT00243230|147622850|SUPERIORITY|||||||0.0028|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0028
74035181|NCT00243230|147622852|SUPERIORITY||Vicriviroc 30mg - Placebo|-1.0||||0.0002|TWO_SIDED|95.0|-1.53|-0.48|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.48|-1.53|0.0002
74035182|NCT00243230|147622852|SUPERIORITY||Vicriviroc 20 mg - Placebo|-0.84||||0.002|TWO_SIDED|95.0|-1.36|-0.31|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.31|-1.36|0.0020
74035183|NCT00243230|147622853|SUPERIORITY||Vicriviroc 30 mg - Placebo|-1.1||||0.0003|TWO_SIDED|95.0|-1.69|-0.51|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA \<=100,000 copies/mL.||||-0.51|-1.69|0.0003
74035184|NCT00243230|147622853|SUPERIORITY||Vicriviroc 20 mg - Placebo|-1.07||||0.0004|TWO_SIDED|95.0|-1.66|-0.49|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA \<=100,000 copies/mL.||||-0.49|-1.66|0.0004
74035185|NCT00243230|147622854|SUPERIORITY||VCV 30 mg - Placebo|57.76||||0.0264|TWO_SIDED|95.0|6.9|108.61|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||108.61|6.90|0.0264
74035186|NCT00243230|147622854|SUPERIORITY||VCV 20 mg - Placebo|42.36||||0.102|TWO_SIDED|95.0|-8.55|93.28|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||93.28|-8.55|0.1020
74035187|NCT00243230|147622855|SUPERIORITY||VCV 30 mg - Placebo|38.12||||0.1525|TWO_SIDED|95.0|-14.32|90.56|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||90.56|-14.32|0.1525
74035188|NCT00243230|147622855|SUPERIORITY||VCV 20 mg - Placebo|44.12||||0.0987|TWO_SIDED|95.0|-8.38|96.61|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||96.61|-8.38|0.0987
74035189|NCT00243230|147622856|SUPERIORITY||VCV 30 mg - Placebo|37.32||||0.2603|TWO_SIDED|95.0|-28.05|102.68|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||102.68|-28.05|0.2603
74089959|NCT02312713|147732648|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.14||||0.81|TWO_SIDED|95.0|-1.03|1.31|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Strength.||1.31|-1.03|0.81
73990079|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3061|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 72 h PS;||||0.3061
73990080|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;||||0.2207
73876012|NCT03629886|147293986|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2547). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||1.18|0.88|
73876013|NCT03629886|147293987|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.25|||||TWO_SIDED|95.0|0.19|0.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2818). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.33|0.19|
73876014|NCT03629886|147293987|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.21|||||TWO_SIDED|95.0|1.06|1.37||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2815). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.37|1.06|
73876015|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.17|||||TWO_SIDED|95.0|0.11|0.24||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2718). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.24|0.11|
73876016|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2722). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.99|0.72|
73876017|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.1|||||TWO_SIDED|95.0|0.06|0.15||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.15|0.06|
73876018|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.47||||||95.0|0.38|0.58||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.58|0.38|
73990081|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;||||0.3173
73990082|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.9191
73990083|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.3173
73990084|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.2207
73990085|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6692|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.6692
73990086|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7793|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.7793
73990087|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6065|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.6065
73990088|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.357|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.3570
73990089|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.969|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.9690
73990090|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5299|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.5299
73990091|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4821|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.4821
73990092|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8295|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.8295
73990093|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3304|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.3304
73990094|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 3 h PS;||||0.2482
73990095|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.2482
74035190|NCT00243230|147622856|SUPERIORITY||VCV 20 mg - Placebo|69.08||||0.0387|TWO_SIDED|95.0|3.64|134.52|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||134.52|3.64|0.0387
74035191|NCT00243230|147622858|SUPERIORITY|||||||0.0031|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0031
74035192|NCT00243230|147622858|SUPERIORITY|||||||0.048|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0480
74035193|NCT00243230|147622859|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
73990096|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.2207
73990097|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8055|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.8055
73990098|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.9191
73990099|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8488|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.8488
73990100|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.2482
73990101|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2482
73990102|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2207
74035194|NCT00243230|147622859|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
74035195|NCT00243230|147622861|SUPERIORITY|||||||0.0225|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0225
74035196|NCT00243230|147622861|SUPERIORITY|||||||0.0582|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0582
73990103|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2482
73990104|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3291|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.3291
73990105|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1391|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.1391
73990106|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6318|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.6318
73990107|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6319|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.6319
73990108|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8149|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.8149
73990109|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5795|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.5795
73990110|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;||||0.1750
73990111|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0676|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;||||0.0676
73990112|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2943|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;||||0.2943
73990113|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0719|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;||||0.0719
73990114|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9283|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.9283
73990115|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9024|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.9024
73990116|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7655|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.7655
73990117|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||1.0000
73990118|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.846|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||0.8460
74035197|NCT00243230|147622862|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
74035198|NCT00243230|147622862|SUPERIORITY|||||||0.0038|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0038
74035199|NCT00243230|147622863|SUPERIORITY|||||||0.0002|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0002
74035200|NCT00243230|147622863|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0004
73990119|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6419|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||0.6419
74035201|NCT02669862|147622938|OTHER|||||||0.555|||||||ANCOVA|Baseline values were the covariate||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."||||0.555
73990120|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9522|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.9522
73990121|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.5800
73990122|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7675|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.7675
73990123|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1672|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.1672
73990124|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9634|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.9634
74035202|NCT02669862|147622938|OTHER|||||||0.009||||||PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate. No adjustments for multiple comparisons.|ANCOVA|||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."||||0.009
74035203|NCT02669862|147622940|OTHER|||||||0.9313||||||Not adjusted for multiple comparisons|Chi-squared|||PVal\*- Chi-Square test used for calculating P-value by comparing Vehicle against each Active treatment group||||0.9313
73876019|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.21|||||TWO_SIDED|95.0|0.15|0.28||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2786). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.28|0.15|
73990125|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1161|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.1161
73990126|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0754|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0754
73990127|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0711|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0711
73876020|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.48|||||TWO_SIDED|95.0|0.39|0.59||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2782). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.59|0.39|
73990128|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0711|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0711
73990129|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.2482
73990130|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8091|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.8091
73990131|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.2482
73990132|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.3173
73990133|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.3173
73990134|NCT00551135|147525950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4386|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.4386
73990135|NCT00551135|147525951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1723|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.1723
73990136|NCT00551135|147525951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0639|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS||||0.0639
73990137|NCT00551135|147525951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.0021
73990138|NCT00551135|147525951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1127|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.1127
73990139|NCT00551135|147525951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0703|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.0703
73990140|NCT00551135|147525951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.0012
73990141|NCT00551135|147525953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1927|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.1927
73990142|NCT00551135|147525953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3865|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS||||0.3865
73990143|NCT00551135|147525953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9869|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.9869
74035204|NCT02669862|147622940|OTHER|||||||0.0236||||||Not adjusted for multiple comparisons|Chi-squared|||||||0.0236
73990144|NCT00551135|147525953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4354|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.4354
73990145|NCT00551135|147525953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8061|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.8061
73990146|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1682|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1682
73990147|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2821|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2821
73990148|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4781|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4781
73990149|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0557|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0557
73990150|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6098|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6098
73990151|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1821|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1821
73990152|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1628|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1628
73990153|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8999|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8999
73990154|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3990
73990155|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2665|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2665
73990156|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4885|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4885
73990157|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6415|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6415
73990158|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2269|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2269
73990159|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3228|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3228
73990160|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1808
73990161|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3282|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3282
73990162|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0342|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0342
73990163|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4198|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4198
74039683|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0075|TWO_SIDED|95.0|1.37|7.69|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||7.69|1.37|0.0075
73876021|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.25|||||TWO_SIDED|95.0|0.18|0.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.33|0.18|
73876022|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.41|||||TWO_SIDED|95.0|0.33|0.51||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2784). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.51|0.33|
73990164|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9049|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9049
73990165|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0456|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0456
73990166|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2463|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2463
73990167|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8231|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8231
73990168|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0221|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0221
73990169|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6974|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6974
73990170|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7461|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7461
73990171|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1198|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1198
73990172|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8031|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8031
73990173|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8515|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8515
73990174|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1285|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1285
73990175|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5561|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5561
73990176|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6858|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6858
74039684|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5374|TWO_SIDED|95.0|0.53|3.34|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.34|0.53|0.5374
74089960|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|1.85||||0|TWO_SIDED|95.0|0.67|3.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Stretching.||3.03|0.67|0.00
74039685|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.89||||0.082|TWO_SIDED|95.0|0.92|3.89|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.89|0.92|0.0820
73876023|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.3|||||TWO_SIDED|95.0|0.23|0.39||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2806). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.39|0.23|
73876024|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.36|||||TWO_SIDED|95.0|0.28|0.46||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2803). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.46|0.28|
73876025|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.88||||||95.0|0.75|1.02||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2759). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.02|0.75|
73876026|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.79|||||TWO_SIDED|95.0|0.67|0.93||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2773). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.93|0.67|
73876027|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.11|||||TWO_SIDED|95.0|0.07|0.16||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2794). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.16|0.07|
73876028|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.21|||||TWO_SIDED|95.0|0.15|0.28||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2802). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.28|0.15|
73990177|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0693|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0693
73990178|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5547|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5547
73990179|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.461|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4610
73990180|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.664|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6640
74035205|NCT05138783|147622941|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, period, and sequence) and random (subject) effects. Difference = PRECISION1 minus BIOTRUE. Sign (either negative or positive) is retained with the rounded value.|||0.00||
73876029|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2753). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.18|0.88|
73876030|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.18|||||TWO_SIDED|95.0|1.03|1.34||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2756). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.34|1.03|
73876031|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.67|||||TWO_SIDED|95.0|1.48|1.87||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2666). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.87|1.48|
73990181|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6158|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6158
73990182|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1632|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1632
73990183|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1770
73990184|NCT00551135|147525954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4882|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4882
73990185|NCT00551135|147525955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7936|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7936
73990186|NCT00551135|147525955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5092|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5092
73990187|NCT00551135|147525955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4233|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4233
73990188|NCT00551135|147525955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2033|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2033
73990189|NCT00551135|147525955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2142|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2142
74035206|NCT00818207|147622942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.0007|TWO_SIDED|95.0|1.23|2.18|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.18|1.23|0.0007
74035207|NCT00818207|147622943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0018|TWO_SIDED|95.0|1.21|2.33|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.33|1.21|0.0018
74035208|NCT00818207|147622944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.2979|TWO_SIDED|95.0|0.82|1.9||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 39 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.90|0.82|0.2979
74035209|NCT00818207|147622944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4388|TWO_SIDED|95.0|0.76|1.87||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.87|0.76|0.4388
73876032|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.8|||||TWO_SIDED|95.0|1.61|2.0||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2663). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||2.00|1.61|
73876033|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.61|||||TWO_SIDED|95.0|0.5|0.73||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2783). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.73|0.50|
73876034|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.64|||||TWO_SIDED|95.0|0.53|0.76||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.76|0.53|
73876035|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.51|||||TWO_SIDED|95.0|0.42|0.62||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2772). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.62|0.42|
73876036|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.65||||||95.0|0.55|0.77||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2768). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.77|0.55|
73990190|NCT00551135|147525955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1218|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1218
73990191|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0830
73990192|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2339|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2339
73990193|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0629|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0629
73990194|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5721|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5721
73990195|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9713|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9713
73990196|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4809|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4809
73990197|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1561|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1561
73876037|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.31|||||TWO_SIDED|95.0|0.24|0.4||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2814). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.40|0.24|
73876038|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.36|||||TWO_SIDED|95.0|0.28|0.45||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2797). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.45|0.28|
73876039|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.62|||||TWO_SIDED|95.0|0.51|0.74||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.74|0.51|
73876040|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.64|||||TWO_SIDED|95.0|0.54|0.77||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2763). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.77|0.54|
73876041|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.56||||||95.0|0.46|0.68||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2775). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.68|0.46|
73990198|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5267|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5267
73990199|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1125|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1125
73990200|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2965|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2965
73990201|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7774|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7774
73990202|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3990
73990203|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4465|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4465
73990204|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4385|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4385
73990205|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2265|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2265
73990206|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5985|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5985
73990207|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2146|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2146
73990208|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3382|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3382
73990209|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0430
73990210|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1128|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1128
73990211|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0632|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0632
73990212|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8667|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8667
73990213|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6365|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6365
73990214|NCT00551135|147525956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9275|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9275
73990215|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2136|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2136
73990216|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0094|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.0094
73990217|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2131|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2131
73990218|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3245|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.3245
73990219|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.407|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.4070
73990220|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.3490
74035210|NCT00818207|147622945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||<|0.0001|TWO_SIDED|95.0|1.35|2.2||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.20|1.35|<0.0001
73990221|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1122|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.1122
73990222|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.1380
74035211|NCT00818207|147622946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.4551|TWO_SIDED|95.0|0.81|1.62||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.62|0.81|0.4551
73990223|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2023|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2023
73990224|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2639|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2639
73990225|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2524|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2524
73990226|NCT00551135|147525958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0832|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.0832
73990227|NCT00551135|147525959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2371|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.2371
73990228|NCT00551135|147525959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4435|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.4435
73990229|NCT00551135|147525959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1692|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.1692
73990230|NCT00551135|147525959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8169|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.8169
73990231|NCT00551135|147525959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5592|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.5592
73990232|NCT00551135|147525959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4453|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.4453
73990233|NCT00551135|147525959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4795|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.4795
73990234|NCT00551135|147525959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2733|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.2733
73990235|NCT00551135|147525959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.3173
73990236|NCT00858247|147525962|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
73990237|NCT00858247|147525963|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANCOVA|||||||0.80
73990238|NCT00858247|147525964|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANCOVA|||||||0.65
73990239|NCT00858247|147525965|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|||||||0.68
73990240|NCT00858247|147525966|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANCOVA|||||||0.40
73990241|NCT00858247|147525967|SUPERIORITY_OR_OTHER|||||||0.47|||||||ANCOVA|||||||0.47
74089961|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|1.62||||0|TWO_SIDED|95.0|0.55|2.68|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Stretching.||2.68|0.55|0.00
73990242|NCT03672175|147526051|SUPERIORITY||Least Square (LS) Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.85||0.6638|TWO_SIDED|95.0|-2.0|1.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Mixed effect model for repeated measures (MMRM)||1.3|-2.0|0.6638
73990243|NCT03672175|147526051|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.89||0.1158|TWO_SIDED|95.0|-3.1|0.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||||0.3|-3.1|0.1158
73990244|NCT03672175|147526052|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.6905|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for the analysis. Treatment, BL CGI-S score, BL antidepressant use, assessment time point, and time point-by-treatment interaction were included in the model and were treated as fixed effects.|MMRM|||||0.2|-0.4|0.6905
73990245|NCT03672175|147526052|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1082|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for the analysis. Treatment, BL CGI-S score, BL antidepressant use, assessment time point, and time point-by-treatment interaction were included in the model and were treated as fixed effects.|MMRM|||||0.1|-0.5|0.1082
73990246|NCT03672175|147526053|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.65||0.5725|TWO_SIDED|95.0|-1.7|0.9||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 3||0.9|-1.7|0.5725
73990247|NCT03672175|147526053|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.64||0.016|TWO_SIDED|95.0|-2.8|-0.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 3||-0.3|-2.8|0.0160
73990248|NCT03672175|147526053|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.75||0.445|TWO_SIDED|95.0|-2.1|0.9||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 8||0.9|-2.1|0.4450
73876042|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.59|||||TWO_SIDED|95.0|0.49|0.71||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2785). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.71|0.49|
73876043|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.5|||||TWO_SIDED|95.0|0.41|0.61||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.61|0.41|
73876044|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.97|||||TWO_SIDED|95.0|0.84|1.12||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2824). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.12|0.84|
73876045|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.75|||||TWO_SIDED|95.0|0.63|0.88||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.88|0.63|
73876046|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|2.11|||||TWO_SIDED|95.0|1.91|2.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||2.33|1.91|
73990249|NCT03672175|147526053|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0081|TWO_SIDED|95.0|-3.6|-0.5||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 8||-0.5|-3.6|0.0081
73990250|NCT03672175|147526053|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.95||0.8219|TWO_SIDED|95.0|-1.6|2.1||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 42||2.1|-1.6|0.8219
73990251|NCT03672175|147526053|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.92||0.8166|TWO_SIDED|95.0|-2.0|1.6||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 42||1.6|-2.0|0.8166
73990252|NCT03672175|147526053|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.9|TWO_SIDED|95.0|-2.3|2.0||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 182||2.0|-2.3|0.9000
73990253|NCT03672175|147526053|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.03||0.5004|TWO_SIDED|95.0|-2.7|1.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 182||1.3|-2.7|0.5004
73990254|NCT03672175|147526054|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8903|TWO_SIDED|95.0|0.65|1.63||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15: Generalized estimating equation (GEE)||1.63|0.65|0.8903
74039686|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0108|TWO_SIDED|95.0|1.23|4.81|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.81|1.23|0.0108
73990255|NCT03672175|147526054|SUPERIORITY||Odds Ratio (OR)|1.43||||0.1207|TWO_SIDED|95.0|0.91|2.25||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||2.25|0.91|0.1207
73990256|NCT03672175|147526054|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7897|TWO_SIDED|95.0|0.67|1.7||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.70|0.67|0.7897
73990257|NCT03672175|147526054|SUPERIORITY||Odds Ratio (OR)|1.1||||0.6837|TWO_SIDED|95.0|0.69|1.76||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.76|0.69|0.6837
73990258|NCT03672175|147526054|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6602|TWO_SIDED|95.0|0.51|1.53||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||1.53|0.51|0.6602
73990259|NCT03672175|147526054|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9268|TWO_SIDED|95.0|0.56|1.69||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||1.69|0.56|0.9268
73990260|NCT03672175|147526055|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8245|TWO_SIDED|95.0|0.62|1.83||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.83|0.62|0.8245
73990261|NCT03672175|147526055|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0756|TWO_SIDED|95.0|0.95|2.67||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||2.67|0.95|0.0756
73990262|NCT03672175|147526055|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5309|TWO_SIDED|95.0|0.7|2.01||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||2.01|0.70|0.5309
73990263|NCT03672175|147526055|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9085|TWO_SIDED|95.0|0.56|1.66||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.66|0.56|0.9085
73990264|NCT03672175|147526055|SUPERIORITY||Odds Ratio (OR)|1.34||||0.3476|TWO_SIDED|95.0|0.73|2.44||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||2.44|0.73|0.3476
73990265|NCT03672175|147526055|SUPERIORITY||Odds Ratio (OR)|1.45||||0.206|TWO_SIDED|95.0|0.82|2.57||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||2.57|0.82|0.2060
73990266|NCT03672175|147526056|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8303|TWO_SIDED|95.0|0.67|1.65||GEE for binary response model, with factors for treatment, CGI-S BL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||||1.65|0.67|0.8303
73990267|NCT03672175|147526056|SUPERIORITY||Odds Ratio (OR)|1.43||||0.1199|TWO_SIDED|95.0|0.91|2.24||GEE for binary response model, with factors for treatment, CGI-S BL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||||2.24|0.91|0.1199
73990268|NCT03672175|147526057|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.71||0.5021|TWO_SIDED|95.0|-1.9|0.9||MMRM with treatment, BL HAM-A total score, anti-depressant use at BL (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.9|-1.9|0.5021
73990269|NCT03672175|147526057|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.7||0.2868|TWO_SIDED|95.0|-2.1|0.6||MMRM with treatment, BL HAM-A total score, anti-depressant use at BL (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.6|-2.1|0.2868
73990270|NCT03672175|147526058|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.35||0.5987|TWO_SIDED|95.0|-3.4|1.9||MMRM with treatment, BL MADRS total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||1.9|-3.4|0.5987
73990271|NCT03672175|147526058|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.36||0.1443|TWO_SIDED|95.0|-4.7|0.7||MMRM with treatment, BL MADRS total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.7|-4.7|0.1443
73990272|NCT03672175|147526059|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.87||0.8499|TWO_SIDED|95.0|-3.3|4.0||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.0|-3.3|0.8499
73990273|NCT03672175|147526059|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.88||0.6265|TWO_SIDED|95.0|-4.6|2.8||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.8|-4.6|0.6265
73990274|NCT03672175|147526059|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.97||0.7418|TWO_SIDED|95.0|-3.2|4.5||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.5|-3.2|0.7418
73990275|NCT03672175|147526059|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.94||0.7837|TWO_SIDED|95.0|-4.3|3.3||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.3|-4.3|0.7837
73990276|NCT03672175|147526060|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.74||0.6848|TWO_SIDED|95.0|-4.1|2.7||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.7|-4.1|0.6848
73990277|NCT03672175|147526060|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.72||0.11|TWO_SIDED|95.0|-6.1|0.6||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.6|-6.1|0.1100
73990278|NCT03672175|147526060|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.86||0.509|TWO_SIDED|95.0|-2.4|4.9||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.9|-2.4|0.5090
73990279|NCT03672175|147526060|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.77||0.8948|TWO_SIDED|95.0|-3.2|3.7||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.7|-3.2|0.8948
73990280|NCT03672175|147526061|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.25||0.9591|TWO_SIDED|95.0|-4.5|4.3||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.3|-4.5|0.9591
73990281|NCT03672175|147526061|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|2.28||0.2713|TWO_SIDED|95.0|-7.0|2.0||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.0|-7.0|0.2713
73990282|NCT03672175|147526061|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.43||0.8048|TWO_SIDED|95.0|-4.2|5.4||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||5.4|-4.2|0.8048
73990283|NCT03672175|147526061|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.35||0.7665|TWO_SIDED|95.0|-5.3|3.9||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.9|-5.3|0.7665
73990284|NCT03672175|147526062|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.91||0.8575|TWO_SIDED|95.0|-3.4|4.1||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.1|-3.4|0.8575
73990285|NCT03672175|147526062|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.94||0.1978|TWO_SIDED|95.0|-6.3|1.3||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||1.3|-6.3|0.1978
73990286|NCT03672175|147526062|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|2.08||0.9298|TWO_SIDED|95.0|-3.9|4.3||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.3|-3.9|0.9298
73990287|NCT03672175|147526062|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.03||0.5487|TWO_SIDED|95.0|-5.2|2.8||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||2.8|-5.2|0.5487
73990288|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.627|TWO_SIDED|95.0|-0.2|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Depressed Mood||0.3|-0.2|0.6270
73990289|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5463|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Depressed Mood||0.2|-0.4|0.5463
73990290|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.8716|TWO_SIDED|95.0|-0.3|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Depressed Mood||0.3|-0.3|0.8716
73990291|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4383|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Depressed Mood||0.2|-0.4|0.4383
73990292|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4794|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Feelings of Guilt||0.3|-0.1|0.4794
73990293|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9717|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Feelings of Guilt||0.2|-0.2|0.9717
74039687|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0006|TWO_SIDED|95.0|1.24|2.2|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.24|0.0006
73990294|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3701|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Feelings of Guilt||0.3|-0.1|0.3701
74039688|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.47|2.59|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.59|1.47|<.0001
73990295|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3972|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Feelings of Guilt||0.3|-0.1|0.3972
73990296|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.5761|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Suicide||0.1|-0.1|0.5761
73990297|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.4379|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Suicide||0.1|-0.1|0.4379
73990298|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.6087|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Suicide||0.1|-0.1|0.6087
73990299|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9791|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Suicide||0.1|-0.1|0.9791
73990300|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2093|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early - Early Night||0.1|-0.3|0.2093
73990301|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5189|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early - Early Night||0.1|-0.3|0.5189
73990302|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6617|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early - Early Night||0.2|-0.2|0.6617
73990303|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2632|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early - Early Night||0.3|-0.1|0.2632
73990304|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.274|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Middle - Middle Night||0.1|-0.3|0.2740
73990305|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1185|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Middle - Middle Night||0.0|-0.3|0.1185
73990306|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.945|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Middle - Middle Night||0.2|-0.2|0.9450
74035212|NCT02320695|147622992|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.187|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.05|-0.33|0.187
74035213|NCT02320695|147622992|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.101|TWO_SIDED|95.0|-0.42|0.04|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.04|-0.42|0.101
73990307|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6343|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Middle - Middle Night||0.1|-0.2|0.6343
73990308|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3169|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early Hours - Morning||0.1|-0.3|0.3169
73990309|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.0178|TWO_SIDED|95.0|-0.4|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early Hours - Morning||0.0|-0.4|0.0178
73990310|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8504|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early Hours - Morning||0.2|-0.2|0.8504
73990311|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5647|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early Hours - Morning||0.1|-0.2|0.5647
73990312|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5914|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Work and Activities||0.2|-0.3|0.5914
73990313|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4603|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Work and Activities||0.2|-0.4|0.4603
73990314|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5637|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Work and Activities||0.2|-0.4|0.5637
73990315|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4638|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Work and Activities||0.2|-0.4|0.4638
73990316|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.1846|TWO_SIDED|95.0|0.0|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Retardation||0.2|0.0|0.1846
73990317|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.4837|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Retardation||0.2|-0.1|0.4837
73990318|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.1178|TWO_SIDED|95.0|0.0|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Retardation||0.2|0.0|0.1178
73990319|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.7888|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Retardation||0.1|-0.1|0.7888
73990320|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9496|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Agitation||0.1|-0.1|0.9496
73990321|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0497|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Agitation||0.0|-0.3|0.0497
73990322|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.4189|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Agitation||0.1|-0.2|0.4189
73990323|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1342|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Agitation||0.0|-0.3|0.1342
73990324|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.9202|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Psychic||0.2|-0.3|0.9202
74039689|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0963|TWO_SIDED|95.0|0.96|1.63|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.63|0.96|0.0963
73990325|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.026|TWO_SIDED|95.0|-0.5|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Psychic||0.0|-0.5|0.0260
73990326|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.937|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Psychic||0.2|-0.3|0.9370
73990327|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.844|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Psychic||0.2|-0.3|0.8440
73990328|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.09||0.448|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Somatic||0.3|-0.1|0.4480
74039690|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0332|TWO_SIDED|95.0|1.02|1.71|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.71|1.02|0.0332
73990329|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6345|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Somatic||0.2|-0.1|0.6345
73990330|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4123|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Somatic||0.3|-0.1|0.4123
73990331|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7523|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Somatic||0.2|-0.2|0.7523
73990332|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6505|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Somatic Symptoms Gastrointestinal||0.1|-0.2|0.6505
73990333|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3674|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Somatic Symptoms Gastrointestinal||0.1|-0.3|0.3674
73990334|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.836|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Somatic Symptoms Gastrointestinal||0.2|-0.2|0.8360
73990335|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.687|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Somatic Symptoms Gastrointestinal||0.1|-0.2|0.6870
73990336|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1364|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: General Somatic Symptoms||0.0|-0.3|0.1364
73990337|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1578|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: General Somatic Symptoms||0.0|-0.3|0.1578
73990338|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9062|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: General Somatic Symptoms||0.2|-0.2|0.9062
73990339|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.8596|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: General Somatic Symptoms||0.2|-0.2|0.8596
73990340|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9488|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Genital Symptoms||0.2|-0.2|0.9488
73990341|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1514|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Genital Symptoms||0.0|-0.3|0.1514
73990342|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.5796|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Genital Symptoms||0.1|-0.2|0.5796
74039691|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0007|TWO_SIDED|95.0|1.21|2.01|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.01|1.21|0.0007
73990343|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4739|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Genital Symptoms||0.1|-0.3|0.4739
73990344|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9439|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Hypochondriasis||0.1|-0.1|0.9439
73990345|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.3891|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Hypochondriasis||0.1|-0.2|0.3891
73990346|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0308|TWO_SIDED|95.0|0.0|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Hypochondriasis||0.3|0.0|0.0308
73990347|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.062|TWO_SIDED|95.0|0.0|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Hypochondriasis||0.3|0.0|0.0620
73990348|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.7744|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Loss of Weight||0.1|-0.2|0.7744
73990349|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9312|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Loss of Weight||0.2|-0.1|0.9312
73990350|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.3105|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Loss of Weight||0.1|-0.2|0.3105
73990351|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.8406|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Loss of Weight||0.2|-0.1|0.8406
73990352|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.4834|TWO_SIDED|95.0|-0.1|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insight||0.0|-0.1|0.4834
73990353|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.0961|TWO_SIDED|95.0|-0.1|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insight||0.0|-0.1|0.0961
73990354|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.829|TWO_SIDED|95.0|0.0|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insight||0.0|0.0|0.8290
73990355|NCT03672175|147526063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9546|TWO_SIDED|95.0|0.0|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insight||0.0|0.0|0.9546
73990356|NCT03672175|147526064|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.78||0.1308|TWO_SIDED|95.0|-2.7|0.4||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.4|-2.7|0.1308
73990357|NCT03672175|147526064|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.77||0.0096|TWO_SIDED|95.0|-3.5|-0.5||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||-0.5|-3.5|0.0096
73990358|NCT03672175|147526064|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.86||0.2674|TWO_SIDED|95.0|-0.7|2.7||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||2.7|-0.7|0.2674
73990359|NCT03672175|147526064|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.9771|TWO_SIDED|95.0|-1.7|1.7||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||1.7|-1.7|0.9771
73990360|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|4.42||0.611|TWO_SIDED|95.0|-10.9|6.4||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sSL||6.4|-10.9|0.6110
73990361|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|4.19||0.0581|TWO_SIDED|95.0|-16.2|0.3||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sSL||0.3|-16.2|0.0581
73990362|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|5.68||0.4493|TWO_SIDED|95.0|-15.5|6.9||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sSL||6.9|-15.5|0.4493
73990363|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|6.25||0.5587|TWO_SIDED|95.0|-16.0|8.6||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sSL||8.6|-16.0|0.5587
74035214|NCT02320695|147622992|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.49|-0.1|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.10|-0.49|0.002
74035215|NCT02320695|147622992|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.53|-0.12|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.12|-0.53|<0.001
74039692|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0001|TWO_SIDED|95.0|1.37|2.64|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.64|1.37|0.0001
73990364|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.06||0.5976|TWO_SIDED|95.0|-10.1|5.8||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sWASO||5.8|-10.1|0.5976
73990365|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|5.05||0.9421|TWO_SIDED|95.0|-9.6|10.3||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sWASO||10.3|-9.6|0.9421
73990366|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|4.86||0.5581|TWO_SIDED|95.0|-6.7|12.4||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sWASO||12.4|-6.7|0.5581
73990367|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|5.82||0.4997|TWO_SIDED|95.0|-7.5|15.4||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sWASO||15.4|-7.5|0.4997
73990368|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|24.0|STANDARD_ERROR_OF_MEAN|10.5||0.0224|TWO_SIDED|95.0|3.4|44.7||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sTST||44.7|3.4|0.0224
73990369|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|17.4|STANDARD_ERROR_OF_MEAN|10.93||0.1117|TWO_SIDED|95.0|-4.1|38.9||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sTST||38.9|-4.1|0.1117
73990370|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|14.1|STANDARD_ERROR_OF_MEAN|14.18||0.3208|TWO_SIDED|95.0|-13.8|42.0||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sTST||42.0|-13.8|0.3208
73990371|NCT03672175|147526065|SUPERIORITY||LS Mean Difference|10.3|STANDARD_ERROR_OF_MEAN|13.4||0.444|TWO_SIDED|95.0|-16.1|36.6||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sTST||36.6|-16.1|0.4440
74035216|NCT02320695|147622993|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.023|TWO_SIDED|95.0|-0.54|-0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.05|-0.54|0.023
74035217|NCT02320695|147622993|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.522|TWO_SIDED|95.0|-0.32|0.2|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.20|-0.32|0.522
74039693|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.6|3.05|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.05|1.60|<.0001
74039694|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0235|TWO_SIDED|95.0|1.05|1.95|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.95|1.05|0.0235
73990372|NCT03672175|147526066|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4737|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.1|-0.3|0.4737
73990373|NCT03672175|147526066|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0138|TWO_SIDED|95.0|-0.4|0.0||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.0|-0.4|0.0138
73990374|NCT03672175|147526066|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.1098|TWO_SIDED|95.0|0.0|0.4||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28||0.4|0.0|0.1098
73990375|NCT03672175|147526066|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.6234|TWO_SIDED|95.0|-0.2|0.3||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28||0.3|-0.2|0.6234
73990376|NCT03672175|147526067|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6741|TWO_SIDED|95.0|0.52|1.53||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.53|0.52|0.6741
73990377|NCT03672175|147526067|SUPERIORITY||Odds Ratio (OR)|0.79||||0.3924|TWO_SIDED|95.0|0.46|1.36||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.36|0.46|0.3924
73990378|NCT03672175|147526067|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7307|TWO_SIDED|95.0|0.51|1.6||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 28||1.60|0.51|0.7307
74039695|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0459|TWO_SIDED|95.0|1.01|1.76|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.76|1.01|0.0459
73990379|NCT03672175|147526067|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8358|TWO_SIDED|95.0|0.52|1.7||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 28||1.70|0.52|0.8358
73990380|NCT03672175|147526068|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.72||0.7375|TWO_SIDED|95.0|-1.6|1.2||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: PCS Score||1.2|-1.6|0.7375
73990381|NCT03672175|147526068|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.74||0.5144|TWO_SIDED|95.0|-1.9|1.0||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: PCS Score||1.0|-1.9|0.5144
73990382|NCT03672175|147526068|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79||0.8343|TWO_SIDED|95.0|-1.7|1.4||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: PCS Score||1.4|-1.7|0.8343
73990383|NCT03672175|147526068|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.85||0.4569|TWO_SIDED|95.0|-1.0|2.3||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: PCS Score||2.3|-1.0|0.4569
73990384|NCT03672175|147526068|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.63||0.4663|TWO_SIDED|95.0|-2.0|4.4||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: MCS Score||4.4|-2.0|0.4663
73990385|NCT03672175|147526068|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.68||0.1138|TWO_SIDED|95.0|-0.6|6.0||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: MCS Score||6.0|-0.6|0.1138
73990386|NCT03672175|147526068|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.74||0.7901|TWO_SIDED|95.0|-3.0|3.9||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: MCS Score||3.9|-3.0|0.7901
73990387|NCT03672175|147526068|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.71||0.3955|TWO_SIDED|95.0|-1.9|4.8||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: MCS Score||4.8|-1.9|0.3955
73990388|NCT03672175|147526069|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.83||0.8821|TWO_SIDED|95.0|-1.8|1.5||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 15||1.5|-1.8|0.8821
73990389|NCT03672175|147526069|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.83||0.151|TWO_SIDED|95.0|-2.8|0.4||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 15||0.4|-2.8|0.1510
73990390|NCT03672175|147526069|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.84||0.2926|TWO_SIDED|95.0|-0.8|2.5||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 42||2.5|-0.8|0.2926
74035218|NCT02320695|147622993|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.67|-0.16|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.16|-0.67|<0.001
74039696|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.54||||0.002|TWO_SIDED|95.0|1.17|2.04|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.04|1.17|0.0020
73990391|NCT03672175|147526069|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.83||0.4785|TWO_SIDED|95.0|-2.2|1.0||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 42||1.0|-2.2|0.4785
73990392|NCT01772563|147526088|OTHER||Geometric mean ratio (GMR) [%]|93.63|||||TWO_SIDED|90.0|82.07|106.81|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV%)=25.1.|"Statistical analysis of Volasertib:~AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||106.81|82.07|
73990393|NCT01772563|147526088|OTHER||Geometric mean ratio (GMR) [%]|75.77|||||TWO_SIDED|90.0|67.83|84.632|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=21.0.|"Statistical analysis of CD 10899:~AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||84.632|67.830|
73990394|NCT01772563|147526089|OTHER||Geometric mean ratio (GMR) [%]|79.4|||||TWO_SIDED|90.0|64.896|97.137|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=39.3.|"Statistical analysis of volasertib:~Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||97.137|64.896|
73990395|NCT01772563|147526089|OTHER||Geometric mean ratio (GMR) [%]|63.48|||||TWO_SIDED|90.0|55.372|72.775|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV%)=26.1.|"Statistical analysis of CD 10899:~Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||72.775|55.372|
73990396|NCT01772563|147526090|OTHER||Geometric mean ratio (GMR) [%]|97.85|||||TWO_SIDED|90.0|87.09|109.94|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=22.7.|"Statistical analysis of volasertib:~AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||109.94|87.09|
73990397|NCT01772563|147526090|OTHER||Geometric mean ratio (GMR) [%]|77.42|||||TWO_SIDED|90.0|69.001|86.871|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=22.5.|"Statistical analysis of CD 10899:~AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||86.871|69.001|
73990398|NCT01192776|147526091|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.76|1.98||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.98|0.76|
73990399|NCT01192776|147526091|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.78|1.87||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.87|0.78|
73990400|NCT01192776|147526091|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.85|||||TWO_SIDED|95.0|0.53|1.35||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.35|0.53|
73990401|NCT01192776|147526092|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.16|||||TWO_SIDED|95.0|0.55|8.49||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||8.49|0.55|
73990402|NCT01192776|147526092|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.52|||||TWO_SIDED|95.0|1.06|5.95||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||5.95|1.06|
73990403|NCT01192776|147526092|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|0.79|4.31||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||4.31|0.79|
73990404|NCT01192776|147526097|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.64|2.38||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.38|0.64|
73990405|NCT01192776|147526097|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.36|1.9||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.90|0.36|
73990406|NCT01192776|147526097|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.26|1.57||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.57|0.26|
73990407|NCT01192776|147526099|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|0.63|2.77||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.77|0.63|
73990408|NCT01192776|147526099|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.42|||||TWO_SIDED|95.0|0.09|2.04||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.04|0.09|
73990409|NCT01192776|147526099|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.2|2.99||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.99|0.20|
73990410|NCT01192776|147526100|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.14|3.01||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||3.01|0.14|
73990411|NCT01192776|147526100|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.44|3.91||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||3.91|0.44|
73990412|NCT01192776|147526100|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.28|||||TWO_SIDED|95.0|0.03|2.89||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.89|0.03|
73990413|NCT01192776|147526101|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.37|2.07||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.07|0.37|
73990414|NCT01192776|147526101|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.3|1.35||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.35|0.30|
73990415|NCT01192776|147526101|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.13|1.64||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.64|0.13|
73876047|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.13|||||TWO_SIDED|95.0|4.79|5.49||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||5.49|4.79|
73876048|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.72|||||TWO_SIDED|95.0|5.36|6.1||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||6.10|5.36|
73990416|NCT04974723|147526104|NON_INFERIORITY|Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.81|1.1||||||||1.10|0.81|
73990417|NCT04974723|147526105|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.89|1.3||||||Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.||1.30|0.89|
73990418|NCT04974723|147526106|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.95|1.22||||||Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.||1.22|0.95|
73990419|NCT01086384|147526108|SUPERIORITY_OR_OTHER||Regression Cox|0.795|||||TWO_SIDED|95.0|0.642|0.985|||||The estimated values is the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|||0.985|0.642|
73990420|NCT01086384|147526108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|15.9||||0.036|TWO_SIDED|95.0|13.5|18.2||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF 100 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.|||18.2|13.5|0.036
73990421|NCT01086384|147526108|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|12.8||||0.036|TWO_SIDED|95.0|10.7|14.9||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF/VI 100/25 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.|||14.9|10.7|0.036
73990422|NCT01721746|147526117|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.68|1.08|||||From stratified cox proportional hazard model with treatment group as a single covariate, stratified by BRAF status, prior anti-CTLA-4 benefit, and PD-L1 status (IVRS source)|Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)||1.08|0.68|
73990423|NCT01721746|147526118|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.1|0.78|1.36|||||Stratified Cox proportional hazard model.|Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)||1.36|0.78|
73990424|NCT01721746|147526119|SUPERIORITY||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.44|3.16||||||For \<5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice||3.16|0.44|
73990425|NCT01721746|147526119|SUPERIORITY||Odds Ratio (OR)|5.49|||||TWO_SIDED|95.0|1.92|19.08||||||For \>=5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice||19.08|1.92|
73990426|NCT01721746|147526120|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.5|1.01|||||From unstratified Cox proportional hazard model|PD-L1 Positive||1.01|0.50|
73990427|NCT01721746|147526121|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.75|1.41|||||From unstratified Cox proportional hazard model|PD-L1 Negative||1.41|0.75|
73990428|NCT04358068|147526129|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.51||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.51
73990429|NCT04358068|147526130|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.79||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.79
73990430|NCT04358068|147526131|SUPERIORITY|Participant specific AUCs were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.53||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.53
73990431|NCT04358068|147526132|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.83||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.83
73990432|NCT02143063|147526145|SUPERIORITY||comparison of rank sum|3752.0||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.01
73990433|NCT02143063|147526145|SUPERIORITY||comparison of rank sum|5287.5||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.78
73990434|NCT02143063|147526146|SUPERIORITY||comparison of rank sum|3675.5||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Primary Aim 1: Compare the standard care and standard care plus traditional CM conditions||||.02
73990435|NCT02143063|147526146|SUPERIORITY||comparison of rank sum|5189.5||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.61
73990436|NCT00909532|147526171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|8.6|12.6||The primary and key secondary endpoints were analyzed using Hochberg's step-up procedure: test 1, primary (α=0.05); test 2, CFQ-R resp domain (Wk24) and sweat chloride (Wk24)(α=0.05).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline values of age and percent predicted FEV1.||12.6|8.6|<0.0001
73990437|NCT00909532|147526172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|8.5|12.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||Analysis of this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were obtained from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for the continuous baseline values of age and percent predicted forced expiratory volume in 1 second (FEV1),using unstructured covariance matrix.||12.5|8.5|<0.0001
73990438|NCT00909532|147526173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|4.7|11.4||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||Through Week 24: Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, domain score, and percent predicted FEV1, using unstructured covariance matrix.||11.4|4.7|<0.0001
73990439|NCT00909532|147526173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|5.3|11.9||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for the CFQ-R respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age,sweat chloride, and percent predicted FEV1,using unstructured covariance matrix.||11.9|5.3|<0.0001
73990440|NCT00909532|147526174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.9|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|-51.3|-44.5||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg's on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.||-44.5|-51.3|<0.0001
73990441|NCT00909532|147526174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|-51.5|-44.7||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.||-44.7|-51.5|<0.0001
73990442|NCT00909532|147526175|SUPERIORITY_OR_OTHER||Cox Proportional Hazard at Week 24|0.4||||0.0016|TWO_SIDED|95.0|0.23|0.71||There was no adjustment for multiple comparisons.|Regression, Cox|||Time to first pulmonary exacerbation through Week 24 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.||0.71|0.23|0.0016
73990443|NCT00909532|147526175|SUPERIORITY_OR_OTHER||Cox Proportional Hazard at 48 Weeks|0.46||||0.0012|TWO_SIDED|95.0|0.28|0.73||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg's on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Regression, Cox|||Time to first pulmonary exacerbation through Week 48 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.||0.73|0.28|0.0012
73990444|NCT00909532|147526176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|1.8|3.7|||Mixed Models Analysis|There was no adjustment for multiple comparisons.||At Week 24: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect, and intercept, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||3.7|1.8|<0.0001
74009214|NCT05293743|147569203|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.23||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 3.70.||The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by iButton temperature sensors.||||0.23
74039697|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.93||||0.0019|TWO_SIDED|95.0|1.27|2.91|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.91|1.27|0.0019
73990445|NCT00909532|147526176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|0.7||0.0001|TWO_SIDED|95.0|1.3|4.1||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect and visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||4.1|1.3|0.0001
73990446|NCT01130168|147526177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||<|0.0005|TWO_SIDED|95.0|-15.3|-10.9|||ANOVA|||||-10.9|-15.3|<0.0005
73990447|NCT01130168|147526177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.016|TWO_SIDED|95.0|-4.9|-0.6|||ANOVA|||||-0.6|-4.9|0.016
73990448|NCT01130168|147526178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.407|TWO_SIDED|95.0|-1.7|4.3|||ANOVA|||||4.3|-1.7|0.407
73990449|NCT01130168|147526178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||<|0.0005|TWO_SIDED|95.0|-8.9|-2.9|||ANOVA|||||-2.9|-8.9|<0.0005
73990450|NCT01130168|147526179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.0005|TWO_SIDED|95.0|-21.2|-10.1|||ANOVA|||||-10.1|-21.2|<0.0005
74035219|NCT02320695|147622993|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.013|TWO_SIDED|95.0|-0.63|-0.07|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.07|-0.63|0.013
73990451|NCT01130168|147526179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3||||0.001|TWO_SIDED|95.0|-17.4|-6.3|||ANOVA|||||-6.3|-17.4|0.001
73990452|NCT01130168|147526180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.186|TWO_SIDED|95.0|-9.5|1.8|||ANOVA|||||1.8|-9.5|0.186
73990453|NCT01130168|147526180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1|||<|0.0005|TWO_SIDED|95.0|-21.7|-10.5|||ANOVA|||||-10.5|-21.7|<0.0005
73990454|NCT01130168|147526181|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-9.2|||<|0.0005|TWO_SIDED|95.0|-12.1|-6.4|||ANOVA|||||-6.4|-12.1|<0.0005
74035220|NCT02702518|147622996|OTHER||||||<|0.001||||||p-values were calculated via linear quantile mixed model for continuous variables with missing data.|Mixed Models Analysis|||For the outcome measure corneal staining, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \< 0.05).||||<0.001
74035221|NCT02702518|147622996|OTHER|||||||0.2324||||||p-values were calculated via linear quantile mixed model for continuous variables with missing data.|Mixed Models Analysis|||For the outcome measure corneal staining data at week 8 was compared with data at baseline to determine significant change.||||0.2324
74035222|NCT02702518|147622997|OTHER|||||||0.001||||||p-values were calculated via linear quantile mixed model for continuous variables.|Mixed Models Analysis|||For the outcome measure OSDI, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \< 0.05).||||0.001
74035223|NCT02702518|147622997|OTHER|||||||0.2257||||||p-values were calculated via linear quantile mixed model for continuous variables.|Mixed Models Analysis|||For the outcome measure OSDI data at week 8 was compared with data at baseline to determine significant change.||||0.2257
73990455|NCT01130168|147526181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.035|TWO_SIDED|95.0|-6.0|-0.3|||ANOVA|||||-0.3|-6.0|0.035
73990456|NCT01130168|147526182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.428|TWO_SIDED|95.0|-6.1|2.6|||ANOVA|||||2.6|-6.1|0.428
73990457|NCT01130168|147526182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||<|0.0005|TWO_SIDED|95.0|-13.1|-4.5|||ANOVA|||||-4.5|-13.1|<0.0005
73990458|NCT01130168|147526183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0005|TWO_SIDED|95.0|-17.5|-10.0|||ANOVA|||||-10.0|-17.5|<0.0005
73990459|NCT01130168|147526183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.015|TWO_SIDED|95.0|-8.5|-1.0|||ANOVA|||||-1.0|-8.5|0.015
73990460|NCT01130168|147526184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.112|TWO_SIDED|95.0|-9.9|1.0|||ANOVA|||||1.0|-9.9|0.112
73990461|NCT01130168|147526184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|||<|0.0005|TWO_SIDED|95.0|-20.7|-9.8|||ANOVA|||||-9.8|-20.7|<0.0005
73990462|NCT01130168|147526185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.0005|TWO_SIDED|95.0|-11.8|-6.2|||ANOVA|||||-6.2|-11.8|<0.0005
73990463|NCT01130168|147526185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.039|TWO_SIDED|95.0|-5.8|-0.2|||ANOVA|||||-0.2|-5.8|0.039
73990464|NCT01130168|147526186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.267|TWO_SIDED|95.0|-6.6|1.8|||ANOVA|||||1.8|-6.6|0.267
73990465|NCT01130168|147526186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0005|TWO_SIDED|95.0|-12.7|-4.3|||ANOVA|||||-4.3|-12.7|<0.0005
73990466|NCT01438840|147526187|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73990467|NCT00859976|147526190|SUPERIORITY|A superiority test was used to calculate the number of patients that are needed in order to show a difference between the bone mineral density surrounding BoneMaster coated cups compared to plasma HA sprayed cups.||||||0.457|||||||Wilcoxon (Mann-Whitney)|Change in bone mineral density, normalised to baseline levels.||||||0.4570
73990468|NCT01702519|147526213|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25|Treatment Ratio|0.946|||||TWO_SIDED|90.0|0.912|0.982|||Treatment Ratio||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the two treatments.||0.982|0.912|
73990469|NCT01702519|147526214|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25.|Treatment Ratio|0.962|||||TWO_SIDED|90.0|0.92|1.0|||Treatment Ratio||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the treatments.||1.00|0.92|
73876049|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.29|||||TWO_SIDED|95.0|4.94|5.65||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||5.65|4.94|
73990470|NCT03738397|147526219|SUPERIORITY||Adjusted Response Rate Difference|9.7||||0.007|TWO_SIDED|95.0|2.6|16.7||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||16.7|2.6|0.007
73990471|NCT03738397|147526220|SUPERIORITY||Least Squares (LS) Mean Difference|-18.21|STANDARD_ERROR_OF_MEAN|2.753|<|0.001|TWO_SIDED|95.0|-23.61|-12.8||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-12.80|-23.61|<0.001
73990472|NCT03738397|147526221|SUPERIORITY||Adjusted Response Rate Difference|20.4|||<|0.001|TWO_SIDED|95.0|14.8|26.0||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||26.0|14.8|<0.001
73990473|NCT03738397|147526222|SUPERIORITY||Adjusted Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|13.8|28.6||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||28.6|13.8|<0.001
73990474|NCT03738397|147526223|SUPERIORITY||LS Mean Difference|-28.02|STANDARD_ERROR_OF_MEAN|3.177|<|0.001|TWO_SIDED|95.0|-34.25|-21.78||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-21.78|-34.25|<0.001
74035224|NCT01000727|147623014|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.929|TWO_SIDED|95.02|0.91|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.09|0.91|0.929
73990475|NCT03738397|147526224|SUPERIORITY||Adjusted Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|19.3|32.7||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||32.7|19.3|<0.001
73990476|NCT03738397|147526225|SUPERIORITY||LS Mean Difference|-23.02|STANDARD_ERROR_OF_MEAN|2.548|<|0.001|TWO_SIDED|95.0|-28.03|-18.02||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-18.02|-28.03|<0.001
73990477|NCT03738397|147526226|SUPERIORITY||Adjusted Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|12.4|27.3||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||27.3|12.4|<0.001
73990478|NCT01795859|147526227|SUPERIORITY_OR_OTHER||LSMean Difference|-2.49|||<|0.0001|TWO_SIDED|95.0|-3.69|-1.29|||ANCOVA|||||-1.29|-3.69|<0.0001
73990479|NCT01795859|147526228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.1||||0.002|TWO_SIDED|95.0|12.4|49.8|||Difference of proportions|||||49.8|12.4|0.0020
73990480|NCT01795859|147526229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.9||||0.0022|TWO_SIDED|95.0|11.4|46.4|||Difference of proportions|||||46.4|11.4|0.0022
73990481|NCT01795859|147526230|SUPERIORITY_OR_OTHER||LSMean Difference|4.34||||0.0308|TWO_SIDED|95.0|0.41|8.27|||Mixed Models Analysis|||||8.27|0.41|0.0308
73990482|NCT01795859|147526231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.1415|TWO_SIDED|95.0|-0.3|2.3|||Mixed Models Analysis|||||2.3|-0.3|0.1415
73990483|NCT00984698|147526238|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm||||<.05
73990484|NCT00984698|147526239|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm||||<.05
73990485|NCT01536197|147526255|SUPERIORITY_OR_OTHER|||||||0.19|||||||ANOVA|Two-way ANOVAs with group (gastric bypass and lap banding) as the between-subjects factor and time (before after surgery).||||||0.19
73990486|NCT03459612|147526316|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in Least Square (LS) means \< 4.4.|Difference in LS Means|0.98|||<|0.0001|TWO_SIDED|95.0|-0.43|2.39|||Mixed Models Analysis|||||2.39|-0.43|<0.0001
73876050|NCT03629886|147293988|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|6.29|||||TWO_SIDED|95.0|5.91|6.69||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||6.69|5.91|
73876051|NCT00346216|147294001|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority required a hazard ratio of 1.12 or lower, as well as an upper 95% confidence limit of 1.33 or lower in the ITT population and of 1.40 or lower in the MITT population.|Hazard Ratio (HR)|0.93||||0.0002|TWO_SIDED|95.0|0.76|1.13||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population||1.13|0.76|0.0002
73876052|NCT00346216|147294001|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.40|Hazard Ratio (HR)|0.9||||0.0001|TWO_SIDED|95.0|0.72|1.14||Non inferiority P value, α=0.025|Regression, Cox|||MITT Population||1.14|0.72|0.0001
73876053|NCT00346216|147294001|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.33|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|95.0|0.7|1.04||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population||1.04|0.70|<0.0001
73876054|NCT00346216|147294001|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|0.81|||<|0.0001|TWO_SIDED|95.0|0.64|1.02||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population||1.02|0.64|<0.0001
73876055|NCT00346216|147294001|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.33|Hazard Ratio (HR)|1.08||||0.0182|TWO_SIDED|95.0|0.89|1.31||Non-inferiority P-value, α=0.025|Regression, Cox|||ITT Population||1.31|0.89|0.0182
73990487|NCT03459612|147526316|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|LS Means|1.76|||<|0.0001|TWO_SIDED|95.0|0.32|3.2|||Mixed Models Analysis|||||3.20|0.32|<0.0001
74035225|NCT01000727|147623015|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.777|TWO_SIDED|95.02|0.9|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.09|0.90|0.777
73876056|NCT00346216|147294001|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|1.12||||0.025|TWO_SIDED|95.0|0.89|1.4||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population||1.40|0.89|0.0250
73876057|NCT00346216|147294002|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.6427|TWO_SIDED|95.0|0.83|1.12|||Regression, Cox|||ITT Population||1.12|0.83|0.6427
73876058|NCT00346216|147294002|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.0597|TWO_SIDED|95.0|0.75|1.01|||Regression, Cox|||ITT Population||1.01|0.75|0.0597
73876059|NCT00346216|147294002|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.11||||0.1481|TWO_SIDED|95.0|0.96|1.29|||Regression, Cox|||ITT Population||1.29|0.96|0.1481
73990488|NCT03459612|147526316|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|LS Means|4.98|||<|0.0001|TWO_SIDED|95.0|3.58|6.38|||Mixed Models Analysis|||||6.38|3.58|<0.0001
73990489|NCT03459612|147526317|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-0.12|||<|0.0001|TWO_SIDED|95.0|-1.28|1.04|||Mixed Models Analysis|||||1.04|-1.28|<0.0001
74035226|NCT01000727|147623016|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.274|TWO_SIDED|95.0|0.76|1.08||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.08|0.76|0.274
73876060|NCT00346216|147294002|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.5758|TWO_SIDED|95.0|0.8|1.13|||Regression, Cox|||MITT Population||1.13|0.80|0.5758
73876061|NCT00346216|147294002|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0204|TWO_SIDED|95.0|0.69|0.97|||Regression, Cox|||MITT Population||0.97|0.69|0.0204
73876062|NCT00346216|147294002|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.0751|TWO_SIDED|95.0|0.98|1.38|||Regression, Cox|||MITT Population||1.38|0.98|0.0751
73990490|NCT03459612|147526317|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-0.32|||<|0.0001|TWO_SIDED|95.0|-1.51|0.88|||Mixed Models Analysis|||||0.88|-1.51|<0.0001
73990491|NCT03459612|147526317|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|4.31|||<|0.0001|TWO_SIDED|95.0|3.17|5.45|||Mixed Models Analysis|||||5.45|3.17|<0.0001
73990492|NCT03459612|147526318|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Differnce in LS Means|-0.97|||<|0.0001|TWO_SIDED|95.0|-2.3|0.36|||Mixed Models Analysis|||||0.36|-2.30|<0.0001
74035227|NCT01000727|147623017|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.631|TWO_SIDED|95.0|0.86|1.09|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.09|0.86|0.631
74035228|NCT01000727|147623018|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.354|TWO_SIDED|95.0|0.88|1.42|||Cox Proportional Hazard Regression Model||A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo|||1.42|0.88|0.354
73876063|NCT00346216|147294003|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.8576|TWO_SIDED|95.0|0.67|1.4|||Regression, Cox|||ITT Population||1.40|0.67|0.8576
73876064|NCT00346216|147294003|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.1202|TWO_SIDED|95.0|0.53|1.08|||Regression, Cox|||ITT Population||1.08|0.53|0.1202
73876065|NCT00346216|147294003|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.27||||0.1734|TWO_SIDED|95.0|0.9|1.81|||Regression, Cox|||ITT Population||1.81|0.90|0.1734
73876066|NCT00346216|147294003|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0041|TWO_SIDED|95.0|0.32|0.81|||Regression, Cox|||MITT Population||0.81|0.32|0.0041
73876067|NCT00346216|147294003|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43||||0.0003|TWO_SIDED|95.0|0.27|0.68|||Regression, Cox|||MITT Population||0.68|0.27|0.0003
73876068|NCT00346216|147294003|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.4243|TWO_SIDED|95.0|0.8|1.69|||Regression, Cox|||MITT Population||1.69|0.80|0.4243
73990493|NCT03459612|147526318|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-1.04|||<|0.0001|TWO_SIDED|95.0|-2.4|0.32|||Mixed Models Analysis|||||0.32|-2.40|<0.0001
73990494|NCT03459612|147526318|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|4.05|||<|0.0001|TWO_SIDED|95.0|2.73|5.38|||Mixed Models Analysis|||||5.38|2.73|<0.0001
73876069|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|1.01|2.53|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||2.53|1.01|<0.0001
73876070|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.39||0.0373|TWO_SIDED|95.0|0.05|1.56|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||1.56|0.05|0.0373
73876071|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.39||0.0129|TWO_SIDED|95.0|0.2|1.72|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||1.72|0.20|0.0129
73876072|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.39||0.183|TWO_SIDED|95.0|-0.25|1.29|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||1.29|-0.25|0.1830
73990495|NCT03459612|147526319|SUPERIORITY||Differences of Least Square Mean|0.28|||||TWO_SIDED|95.0|-0.15|0.7||||||||0.70|-0.15|
73990496|NCT03459612|147526319|SUPERIORITY||Difference of Least Square Means|0.66|||||TWO_SIDED|95.0|0.22|1.1||||||||1.10|0.22|
73990497|NCT03459612|147526319|SUPERIORITY||Difference of Least Square Means|0.81|||||TWO_SIDED|95.0|0.39|1.24||||||||1.24|0.39|
74035229|NCT01000727|147623019|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.161|TWO_SIDED|95.0|0.73|1.05|||Cox Proportional Hazard Regression Model|||||1.05|0.73|0.161
73876073|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.39||0.7777|TWO_SIDED|95.0|-0.88|0.66|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||0.66|-0.88|0.7777
73876074|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.39||0.1072|TWO_SIDED|95.0|-0.14|1.4|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||1.40|-0.14|0.1072
73876075|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.4||0.8237|TWO_SIDED|95.0|-0.12|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||1.46|-0.12|0.8237
73876076|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.4||0.8237|TWO_SIDED|95.0|-0.88|0.7|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||0.70|-0.88|0.8237
73876077|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.4||0.0587|TWO_SIDED|95.0|-0.03|1.55|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||1.55|-0.03|0.0587
73876078|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.41||0.3129|TWO_SIDED|95.0|-0.39|1.23|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.23|-0.39|0.3129
73876079|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.6526|TWO_SIDED|95.0|-0.63|1.0|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.00|-0.63|0.6526
73876080|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.42||0.5774|TWO_SIDED|95.0|-0.58|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.05|-0.58|0.5774
73990498|NCT03459612|147526320|SUPERIORITY||Difference of Least Square Means|0.48|||||TWO_SIDED|95.0|0.0|0.96||||||||0.96|0.00|
73990499|NCT03459612|147526320|SUPERIORITY||Differnce of Least Square Means|0.34|||||TWO_SIDED|95.0|-0.14|0.82||||||||0.82|-0.14|
73990500|NCT03459612|147526320|SUPERIORITY||Difference of Least Square Means|1.29|||||TWO_SIDED|95.0|0.81|1.78||||||||1.78|0.81|
73990501|NCT03459612|147526321|SUPERIORITY||Difference of Least Square Means|-0.58|||||TWO_SIDED|95.0|-1.1|-0.06||||||||-0.06|-1.10|
73990502|NCT03459612|147526321|SUPERIORITY||Difference of Least Square Means|-0.4|||||TWO_SIDED|95.0|-0.89|0.09||||||||0.09|-0.89|
73990503|NCT03459612|147526321|SUPERIORITY||Difference of Least Square Means|0.44|||||TWO_SIDED|95.0|-0.09|0.96||||||||0.96|-0.09|
73990504|NCT03459612|147526322|SUPERIORITY||Difference in Least Square Means|0.0|||||TWO_SIDED|95.0|-1.61|1.62||||||||1.62|-1.61|
73990505|NCT03459612|147526322|SUPERIORITY||Difference in Lease Square Means|-0.74|||||TWO_SIDED|95.0|-2.49|1.01||||||||1.01|-2.49|
73990506|NCT03459612|147526322|SUPERIORITY||Difference in Least Square Means|-0.72|||||TWO_SIDED|95.0|-2.32|0.89||||||||0.89|-2.32|
73990507|NCT03459612|147526323|SUPERIORITY||Difference of Least Square Means|-1.79|||||TWO_SIDED|95.0|-3.52|-0.06||||||||-0.06|-3.52|
73990508|NCT03459612|147526323|SUPERIORITY||Difference in Least Square Means|-0.29|||||TWO_SIDED|95.0|-2.0|1.42||||||||1.42|-2.00|
73990509|NCT03459612|147526323|SUPERIORITY||Difference in Least Square Means|-3.81|||||TWO_SIDED|95.0|-5.53|-2.08||||||||-2.08|-5.53|
73990510|NCT03459612|147526324|SUPERIORITY||Difference of Least Square Means|-0.28|||||TWO_SIDED|95.0|-1.71|1.15||||||||1.15|-1.71|
73990511|NCT03459612|147526324|SUPERIORITY||Difference of Least Square Means|-0.31|||||TWO_SIDED|95.0|-1.71|1.08||||||||1.08|-1.71|
74035230|NCT01000727|147623020|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.36|TWO_SIDED|95.0|0.91|1.31|||Cox Proportional Hazard Regression Model|||||1.31|0.91|0.360
73876081|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.42||0.0632|TWO_SIDED|95.0|-0.04|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.62|-0.04|0.0632
73876082|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.43||0.454|TWO_SIDED|95.0|-0.52|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.15|-0.52|0.4540
73876083|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.43||0.2705|TWO_SIDED|95.0|-0.37|1.3|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.30|-0.37|0.2705
73876084|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.44||0.5225|TWO_SIDED|95.0|-0.58|1.14|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||1.14|-0.58|0.5225
73876085|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.44||0.5996|TWO_SIDED|95.0|-1.1|0.63|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||0.63|-1.10|0.5996
73876086|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.44||0.2461|TWO_SIDED|95.0|-0.35|1.38|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||1.38|-0.35|0.2461
74035231|NCT01000727|147623021|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.202|TWO_SIDED|95.0|0.88|1.03|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.03|0.88|0.202
73876087|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.46||0.8127|TWO_SIDED|95.0|-0.79|1.0|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||1.00|-0.79|0.8127
73876088|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.46||0.9641|TWO_SIDED|95.0|-0.92|0.87|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||0.87|-0.92|0.9641
73876089|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.46||0.7784|TWO_SIDED|95.0|-0.77|1.03|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||1.03|-0.77|0.7784
73876090|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.49||0.2105|TWO_SIDED|95.0|-0.34|1.56|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.56|-0.34|0.2105
73876091|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.49||0.2909|TWO_SIDED|95.0|-0.44|1.46|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.46|-0.44|0.2909
73876092|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.49||0.8459|TWO_SIDED|95.0|-0.86|1.05|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.05|-0.86|0.8459
73876093|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.51||0.1116|TWO_SIDED|95.0|-0.19|1.8|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.80|-0.19|0.1116
73876094|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.51||0.9751|TWO_SIDED|95.0|-0.98|1.01|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.01|-0.98|0.9751
73876095|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.51||0.1202|TWO_SIDED|95.0|-0.21|1.79|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.79|-0.21|0.1202
73876096|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.52||0.3767|TWO_SIDED|95.0|-0.56|1.48|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||1.48|-0.56|0.3767
73876097|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1123|TWO_SIDED|95.0|-1.85|0.19|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||0.19|-1.85|0.1123
73876098|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|0.52||0.0137|TWO_SIDED|95.0|0.26|2.31|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||2.31|0.26|0.0137
74035232|NCT01000727|147623022|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.329|TWO_SIDED|95.0|0.87|1.05|||Cox Proportional Hazard Regression Model|||||1.05|0.87|0.329
74035233|NCT01000727|147623023|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.797|TWO_SIDED|95.0|0.9|1.08|||Cox Proportional Hazard Regression Model|||||1.08|0.90|0.797
73876099|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|1.07|2.47|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||2.47|1.07|<0.0001
73876100|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|0.36||0.0197|TWO_SIDED|95.0|0.13|1.54|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||1.54|0.13|0.0197
73876101|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.36||0.0094|TWO_SIDED|95.0|0.23|1.64|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||1.64|0.23|0.0094
73876102|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.37||0.1247|TWO_SIDED|95.0|-0.16|1.31|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||1.31|-0.16|0.1247
73876103|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.37||0.8278|TWO_SIDED|95.0|-0.81|0.65|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||0.65|-0.81|0.8278
73876104|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.37||0.0802|TWO_SIDED|95.0|-0.08|1.39|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||1.39|-0.08|0.0802
73876105|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.39||0.0822|TWO_SIDED|95.0|-0.09|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||1.46|-0.09|0.0822
74035234|NCT01000727|147623024|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.546|TWO_SIDED|95.0|0.87|1.07|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.07|0.87|0.546
74035235|NCT01000727|147623025|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.362|TWO_SIDED|95.0|0.81|1.08|||Cox Proportional Hazard Regression Model|||||1.08|0.81|0.362
74035236|NCT02207478|147623029|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.019
73876106|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.39||0.8314|TWO_SIDED|95.0|-0.86|0.69|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||0.69|-0.86|0.8314
73876107|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.39||0.0516|TWO_SIDED|95.0|-0.01|1.54|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||1.54|-0.01|0.0516
73876108|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.42||0.3202|TWO_SIDED|95.0|-0.4|1.24|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.24|-0.40|0.3202
73876109|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.42||0.5893|TWO_SIDED|95.0|-0.6|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.05|-0.60|0.5893
73876110|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.42||0.651|TWO_SIDED|95.0|-0.63|1.01|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.01|-0.63|0.6510
73876111|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.44||0.0796|TWO_SIDED|95.0|-0.09|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.62|-0.09|0.0796
73876112|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.44||0.5061|TWO_SIDED|95.0|-0.57|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.15|-0.57|0.5061
73876113|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.44||0.2796|TWO_SIDED|95.0|-0.38|1.33|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.33|-0.38|0.2796
73876114|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.45||0.6725|TWO_SIDED|95.0|-0.69|1.08|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||1.08|-0.69|0.6725
73876115|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.45||0.6381|TWO_SIDED|95.0|-1.1|0.67|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||0.67|-1.10|0.6381
73876116|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.45||0.3737|TWO_SIDED|95.0|-0.49|1.29|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||1.29|-0.49|0.3737
73876117|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||0.9139|TWO_SIDED|95.0|-0.87|0.97|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.97|-0.87|0.9139
73876118|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.47||0.9998|TWO_SIDED|95.0|-0.92|0.92|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.92|-0.92|0.9998
73876119|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||0.9144|TWO_SIDED|95.0|-0.88|0.98|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.98|-0.88|0.9144
73990512|NCT03459612|147526324|SUPERIORITY||Difference of Least Square Means|-2.7|||||TWO_SIDED|95.0|-4.13|-1.27||||||||-1.27|-4.13|
73876120|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.51||0.225|TWO_SIDED|95.0|-0.38|1.61|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.61|-0.38|0.2250
73876121|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.51||0.2758|TWO_SIDED|95.0|-0.44|1.55|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.55|-0.44|0.2758
73876122|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.51||0.903|TWO_SIDED|95.0|-0.94|1.06|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.06|-0.94|0.9030
73990513|NCT03459612|147526325|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.3||0.6875|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.6875
74035237|NCT02207478|147623030|SUPERIORITY_OR_OTHER|||||||0.843|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total procedure time||||0.843
73876123|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.53||0.091|TWO_SIDED|95.0|-0.14|1.94|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.94|-0.14|0.0910
73876124|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.53||0.7668|TWO_SIDED|95.0|-0.88|1.2|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.20|-0.88|0.7668
73876125|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.53||0.1653|TWO_SIDED|95.0|-0.31|1.78|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.78|-0.31|0.1653
73876126|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.55||0.4323|TWO_SIDED|95.0|-0.65|1.52|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||1.52|-0.65|0.4323
73876127|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.55||0.1439|TWO_SIDED|95.0|-1.89|0.28|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||0.28|-1.89|0.1439
73876128|NCT00346216|147294004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|0.55||0.0251|TWO_SIDED|95.0|0.16|2.33|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||2.33|0.16|0.0251
73990514|NCT03459612|147526325|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.27||0.375|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.3750
73990515|NCT03459612|147526325|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|1.0||0.0115|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0115
73990516|NCT03459612|147526326|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.42||0.1563|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.1563
73990517|NCT03459612|147526326|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.44||0.5938|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.5938
73990518|NCT03459612|147526326|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|0.54||0.0938|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0938
74035238|NCT02207478|147623030|SUPERIORITY_OR_OTHER|||||||0.233|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total X-ray time||||0.233
74035239|NCT02207478|147623030|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Duration time for finding lesions||||<0.001
73876129|NCT00904813|147294005|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.38||||0.52|TWO_SIDED|90.0|0.06|2.56||The threshold for statistical significance was p=0.05.|Log Rank|An overall p-value was calculated.|SRT was used as reference group. Estimation described above is for SRT-delay. For LRT-delay HR (90% CI) was 1.22 with lower limit: 0.33, and upper limit: 3.45.|The effect of treatment regimen on local recurrence as first event in the three-armed group comparison (n = 385) was estimated with proportional hazards regression, stratified by participating centre.||2.56|0.06|0.52
73876130|NCT00904813|147294005|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.93||||0.92|TWO_SIDED|95.0|0.64|1.35||The threshold for statistical significance was p=0.05.|Log Rank|An overall p-value was calculated.|SRT was used as reference group (1.00). Estimation described above is for SRT-delay. For LRT-delay HR (95% CI) was 0.99 with lower limit: 0.68, and upper limit: 1.42.|The effect of treatment regimen on recurrence-free survival in the three armed randomisation comparison (n = 385) was estimated with proportional hazards regression, stratified by participating centre.||1.35|0.64|0.92
73876131|NCT00904813|147294005|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.91||||0.59|TWO_SIDED|90.0|0.36|2.27||The threshold for statistical significance was p=0.05.|Log Rank||SRT was used as reference group (1.00). Estimation described above is for SRT-delay.|The effect of treatment regimen on local recurrence as first event in the pooled short-course RT comparison (n = 712) was estimated with proportional hazards regression, stratified by participating centre.||2.27|0.36|0.59
73876132|NCT00904813|147294005|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.9||||0.39|TWO_SIDED|95.0|0.69|1.18||The threshold for statistical significance was p=0.05.|Log Rank||SRT was used as reference group. Estimation described above is for SRT-delay.|The effect of treatment regimen on recurrence-free survival in the pooled short-course RT comparison (n = 712) was estimated with proportional hazards regression, stratified by participating centre.||1.18|0.69|0.39
73876133|NCT00904813|147294006|SUPERIORITY||Odds Ratio (OR)|0.72||||0.289|TWO_SIDED|95.0|0.4|1.32||The threshold of statistical significance was p=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||1.32|0.40|0.289
73876134|NCT00904813|147294006|SUPERIORITY||Odds Ratio (OR)|0.5||||0.009|TWO_SIDED|95.0|0.3|0.84||The threshold for statistical significance was p=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||0.84|0.30|0.009
73990519|NCT03459612|147526327|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.56||0.125|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.1250
73990520|NCT03459612|147526327|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.94||0.959|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.9590
73990521|NCT03459612|147526327|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_DEVIATION|1.76||0.0097|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0097
73990522|NCT00497874|147526386|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.003||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(145) = 2.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, the t-test-and the results pooled.||||.003
73990523|NCT00497874|147526387|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.002||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(181) = 2.9||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.002
73990524|NCT00497874|147526388|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.04||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(153) = 1.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.04
73876135|NCT00904813|147294006|SUPERIORITY||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.23|0.65||The threshold for statistical significance was p-value=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||0.65|0.23|<0.001
73990525|NCT00497874|147526389|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.07||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(57) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.07
73990526|NCT00497874|147526390|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.05||95.0|||||t-test, 1 sided|t(94) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.05
73990527|NCT00497874|147526391|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.13||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(123) = 1.2||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, the t-test-and the results pooled.||||.13
73990528|NCT03568812|147526439|SUPERIORITY||Mean Difference (Net)|111.8||||0.02|TWO_SIDED|95.0|40.9|182.7||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of unadjusted CD4 level||182.7|40.9|0.02
73990529|NCT03568812|147526439|SUPERIORITY||Mean Difference (Net)|73.4||||0.03|TWO_SIDED|95.0|5.9|140.8||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of adjusted CD4 level||140.8|5.9|0.03
73990530|NCT03568812|147526440|SUPERIORITY||Mean Difference (Net)|0.3||||0.55|TWO_SIDED|95.0|-0.5|1.0||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||There is no difference between probiotics - placebo|The statistical analysis of unadjusted Th17 change after intervention||1.0|-0.5|0.55
73990531|NCT03568812|147526440|SUPERIORITY||Mean Difference (Net)|0.1||||0.79|TWO_SIDED|95.0|-0.7|0.9||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||There is no difference between probiotics - placebo|The statistical analysis of adjusted Th17 change after intervention||0.9|-0.7|0.79
73990532|NCT03568812|147526442|SUPERIORITY||Mean Difference (Net)|-12.7||||0.03|TWO_SIDED|95.0|-23.9|-1.5||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of unadjusted Fecal Calprotectin Level change after intervention||-1.5|-23.9|0.03
73990533|NCT03568812|147526442|SUPERIORITY||Mean Difference (Net)|-15.6||||0.01|TWO_SIDED|95.0|-27.6|-3.6||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of adjusted Fecal Calprotectin Level change after intervention||-3.6|-27.6|0.01
73990534|NCT03568812|147526444|SUPERIORITY|||||||0.551||||||The threshold for statistical significance was p = 0.05|Chi-squared|||The statistical analysis of food frequency change after intervention (12 weeks)||||0.551
73990535|NCT01196819|147526461|NON_INFERIORITY|Non-inferiority margin is 0.13mm, if the two-sided upper 95% confidence bound is \<Δ, the Firehawk Stent being tested will be considered non-inferior to the control. This corresponds to a P value \<0.05 from a two-sided Student t-test comparing the difference between FirehawkStent and Xience stent to delta.|Mean Difference (Final Values)|0.17||||0.94|TWO_SIDED|95.0|0.0|0.29|||ANCOVA|||H0: Pe - Pc≥ ∆, H1: Pe - Pc \< ∆. Pe and Pc are the mean 9-month in-stent late loss for the subject in the Firehawk DES group and the Xience group, respectively. ∆ is the non-inferiority margin. A two-sided upper 95% confidence bound will be calculated for the difference in 9-month in-stent late loss .||0.29|0|0.94
74035240|NCT02207478|147623030|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||X-ray time for finding lesions||||<0.001
73990536|NCT01196819|147526462|NON_INFERIORITY|Assume the in-stent percent diameter stenosis of both FIREHAWK and XIENCE V are 16 ± 16%, the non-inferiority value is 5%, the level of statistical significance is 0.05 (bilateral test), the power is 85%.||||||0.69|||||||Mixed Models Analysis|||||||0.69
73990537|NCT01196819|147526463|OTHER|||||||1|||||||Fisher Exact|||||||1.0
73990538|NCT01196819|147526464|OTHER|||||||0.76|||||||Fisher Exact|||||||0.76
73990539|NCT01196819|147526465|OTHER|||||||0.77|||||||Fisher Exact|||||||0.77
73990540|NCT01196819|147526466|OTHER|||||||1|||||||Fisher Exact|||||||1.0
73990541|NCT03732820|147526476|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.81||A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided.|Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.81|0.54|<0.0001
74035241|NCT01830543|147623052|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||<|0.001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.001
74035242|NCT01830543|147623052|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.5|0.8|||Log Rank|||||0.8|0.5|<0.001
74035243|NCT01830543|147623053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.234|TWO_SIDED|95.0|0.33|1.31|||Log Rank|||||1.31|0.33|0.234
74035244|NCT01830543|147623053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.114|TWO_SIDED|95.0|0.28|1.16|||Log Rank|||||1.16|0.28|0.114
74035245|NCT01830543|147623054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51||||0.144|TWO_SIDED|95.0|0.2|1.28|||Log Rank|||||1.28|0.2|0.144
73876136|NCT00904813|147294006|SUPERIORITY||Odds Ratio (OR)|1.58||||0.521|TWO_SIDED|95.0|0.39|6.37||The threshold for statistical significance was p-value = 0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group E was used as the reference group.|The association between postoperative complications and long-course RT by overall treatment time was assessed using logistic regression analysis.||6.37|0.39|0.521
73876137|NCT00904813|147294007|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.046|TWO_SIDED|95.0|0.26|0.99||The threshold for statistical significance was p=0.05.|Regression, Cox|Model adjusted for age, sex and type of surgery.|No pCR was used as reference group.|The association between pathological complete response (pCR), eg no signs of viable tumour or metastatic nodes (T0N0) and overall survival (OS) was assessed using Cox-regression model.||0.99|0.26|0.046
73876138|NCT03985761|147294022|SUPERIORITY|||||||0.182|||||||ANOVA|||||||.182
73990542|NCT03732820|147526477|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0544|TWO_SIDED|95.0|0.67|1.0||A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided. Alpha spend for OS will not exceed 0.02135.|Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.00|0.67|0.0544
73990543|NCT03732820|147526478|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0025|TWO_SIDED|95.0|0.64|0.9|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.90|0.64|0.0025
73990544|NCT03732820|147526479|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7456|TWO_SIDED|95.0|0.75|1.5|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.50|0.75|0.7456
73990545|NCT03732820|147526480|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.3099|TWO_SIDED|95.0|0.82|1.79|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.79|0.82|0.3099
73990546|NCT03732820|147526481|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3212|TWO_SIDED|95.0|0.55|1.22|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.22|0.55|0.3212
73990547|NCT03732820|147526482|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0534|TWO_SIDED|95.0|0.59|0.99|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.99|0.59|0.0534
74035246|NCT01830543|147623054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5||||0.134|TWO_SIDED|95.0|0.2|1.26|||Log Rank|||||1.26|0.2|0.134
74035247|NCT01830543|147623055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||||0.8|0.47|<0.001
74035248|NCT01830543|147623055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.002|TWO_SIDED|95.0|0.52|0.86|||Log Rank|||||0.86|0.52|0.002
74035249|NCT01830543|147623056|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.75|TWO_SIDED|95.0|0.69|1.68|||Log Rank|||||1.68|0.69|0.75
73876139|NCT03985761|147294023|SUPERIORITY|||||||0.296|||||||ANOVA|||||||.296
73990548|NCT00992992|147526485|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|56.0|||||TWO_SIDED|95.0|37.0|75.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response (CR).|||75|37|
73990549|NCT00992992|147526485|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|8.0|||||TWO_SIDED|95.0|0.0|19.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response unconfirmed (CRu).|||19|0|
74035250|NCT01830543|147623056|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.765|TWO_SIDED|95.0|0.59|1.48|||Log Rank|||||1.48|0.59|0.765
74035251|NCT01830543|147623057|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.523|TWO_SIDED|95.0|0.59|2.8|||Log Rank|||||2.8|0.59|0.523
74035252|NCT01830543|147623057|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.664|TWO_SIDED|95.0|0.54|2.62|||Log Rank|||||2.62|0.54|0.664
74035253|NCT01830543|147623058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.625|TWO_SIDED|95.0|0.46|1.59|||Log Rank|||||1.59|0.46|0.625
74035254|NCT01830543|147623058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.374|TWO_SIDED|95.0|0.4|1.42|||Log Rank|||||1.42|0.4|0.374
74035255|NCT01830543|147623059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.891|TWO_SIDED|95.0|0.39|2.96|||Log Rank|||||2.96|0.39|0.891
74035256|NCT01830543|147623059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||0.53|TWO_SIDED|95.0|0.52|3.58|||Log Rank|||||3.58|0.52|0.53
74035257|NCT01830543|147623060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.79|TWO_SIDED|95.0|0.32|4.45|||Log Rank|||||4.45|0.32|0.79
74035258|NCT01830543|147623060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.574|TWO_SIDED|95.0|0.4|5.09|||Log Rank|||||5.09|0.4|0.574
74035259|NCT02059213|147623061|SUPERIORITY|||||||0.87|||||||Fisher Exact|Mid P-value||With 20 patients treated with ADT and 40 treated with ADT + palbociclib there is a 64.2% power to detect a 20% difference in proportions with a one-sided type I error of 0.10 using the mid p-value method of the Fisher's exact test.||||0.87
74035260|NCT02059213|147623063|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||||||0.92
73876140|NCT03985761|147294024|SUPERIORITY|||||||0.483|||||||ANOVA|||||||.483
73990550|NCT00992992|147526485|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|20.0|||||TWO_SIDED|95.0|4.0|36.0|||||The estimated value reflects the percentage of participants with unconfirmed partial response.|||36|4|
73990551|NCT00832000|147526506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_DEVIATION|1.24|<|0.001|TWO_SIDED|95.0|-2.66|-0.706|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.706|-2.66|<0.001
73990552|NCT00832000|147526506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68|STANDARD_DEVIATION|1.24||0.04||95.0|-3.85|-0.139|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.139|-3.85|0.04
73990553|NCT00832000|147526507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|STANDARD_DEVIATION|1.19|<|0.001|TWO_SIDED|95.0|-2.0|-1.26|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-1.26|-2.00|<0.001
73990554|NCT00832000|147526508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_DEVIATION|1.27|<|0.001|TWO_SIDED|95.0|-1.67|-0.861|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.861|-1.67|<0.001
73990555|NCT00832000|147526509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.918|STANDARD_DEVIATION|1.29|<|0.001|TWO_SIDED|95.0|-1.3|-0.532|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.532|-1.30|<0.001
73990556|NCT00832000|147526510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.109|STANDARD_DEVIATION|0.563|<|0.001|TWO_SIDED|95.0|-0.177|-0.056|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.056|-0.177|<0.001
73990557|NCT00832000|147526511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|STANDARD_DEVIATION|13.1||0.09|TWO_SIDED|95.0|-0.68|9.75|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||9.75|-0.680|0.09
73990558|NCT00832000|147526512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.568|STANDARD_DEVIATION|0.6|<|0.001|TWO_SIDED|95.0|-0.812|-0.325|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.325|-0.812|<0.001
73990559|NCT00832000|147526513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|1.083|<|0.001|TWO_SIDED|95.0|-0.633|-0.142|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.142|-0.633|<0.001
74035261|NCT02059213|147623064|SUPERIORITY|||||||0.5|||||||Fisher Exact|Mid p-value||||||0.50
74035262|NCT02059213|147623065|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.72
74035263|NCT02059213|147623066|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
73876141|NCT03985761|147294025|SUPERIORITY|||||||0.995|||||||ANOVA|||||||.995
73876142|NCT03985761|147294026|SUPERIORITY|||||||0.22|||||||ANOVA|||||||.220
73876143|NCT03985761|147294027|SUPERIORITY|||||||0.538|||||||ANOVA|||||||.538
73990560|NCT00832000|147526514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.313|STANDARD_DEVIATION|0.889|<|0.001|TWO_SIDED|95.0|-0.602|-0.149|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.149|-0.602|<0.001
74035264|NCT01640925|147623097|NON_INFERIORITY_OR_EQUIVALENCE|The number of patients needed to achieve 80% power was estimated at 171 using Cox proportional hazards regression (hazard ratio reduction of 0.66; 0.15 probability of infection with control) using a two-sided 5% significance.|Cox Proportional Hazard|0.555||||0.049|TWO_SIDED|95.0|0.309|0.998|||Regression, Cox||Hypothesis: Compared to soap and water daily bathing, 2% chlorhexidine gluconate bathing on ICU admission and every 48 hours during surgical ICU care will decrease the risk of acquiring four hospital-acquired infections in surgical ICU patients.|||0.998|0.309|0.049
74035265|NCT02420223|147623121|SUPERIORITY|||||||0.017|||||||Regression, Logistic|||||||.017
74035266|NCT02420223|147623121|SUPERIORITY|||||||0.337|||||||Regression, Logistic|||||||0.337
74035267|NCT02420223|147623124|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
74035268|NCT02420223|147623125|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
74035269|NCT02420223|147623126|SUPERIORITY|||||||0.06|||||||Likelihood ration Chi-Square test|||||||0.06
73990561|NCT00832000|147526515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.464|STANDARD_DEVIATION|0.516|<|0.001|TWO_SIDED|95.0|-0.675|-0.254|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.254|-0.675|<0.001
73990562|NCT00832000|147526516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_DEVIATION|12.6||0.5|TWO_SIDED|95.0|-3.34|6.73|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||6.73|-3.34|0.50
73990563|NCT00832000|147526517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|STANDARD_DEVIATION|3.44|<|0.001|TWO_SIDED|95.0|-4.07|-1.3|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-1.30|-4.07|<0.001
73990564|NCT00832000|147526518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.58|STANDARD_DEVIATION|5.35|<|0.001|TWO_SIDED|95.0|3.44|7.72|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||7.72|3.44|<0.001
73990565|NCT00832000|147526519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|STANDARD_DEVIATION|6.5||0.9|TWO_SIDED|95.0|-5.87|5.17|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||5.17|-5.87|0.90
73990566|NCT00832000|147526519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|6.5||0.03|TWO_SIDED|95.0|0.941|20.6|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||20.6|0.941|0.03
73990567|NCT00817336|147526562|SUPERIORITY_OR_OTHER||Cohen's d|0.8||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
73990568|NCT00817336|147526563|SUPERIORITY||Cohen's d|2.3||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
73990569|NCT00817336|147526564|SUPERIORITY_OR_OTHER||Cohen's d|0.41||||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||.31
73990570|NCT00817336|147526565|SUPERIORITY||Cohen's d|0.41||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||.41
73990571|NCT03311269|147526586|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-6.2|-2.3||This p-value corresponds to the change from Baseline to Week 12 for both treatment groups (ClariVein RES 1% Injection and ClariVein RES 3% Injection) combined.|t-test, 2 sided|One-Sample||Continuous variables summarized using descriptive statistics, specifically the mean, median, standard deviation, minimum and maximum. Categorical variables summarized using frequencies and percentages. All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated. For efficacy analyses, missing post-treatment data will be imputed using last observation carried forward (LOCF). Missing safety data will not be imputed.||-2.3|-6.2|<0.001
73990572|NCT03311269|147526586|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-3.4||||0.011|TWO_SIDED|95.0|-5.8|-1.0||This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 1% Injection treatment group.|t-test, 2 sided|One-Sample||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||-1.0|-5.8|0.011
73990573|NCT03311269|147526586|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-5.1||||0.01|TWO_SIDED|95.0|-8.7|-1.6||This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 3% Injection treatment group.|t-test, 2 sided|One-Sample||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||-1.6|-8.7|0.010
73990574|NCT03311269|147526586|OTHER|An ANCOVA was performed to compare the change from baseline for ClariVein RES 1% Injection versus ClariVein RES 3% Injection with treatment as the class variable and with baseline score as the covariate|Least-Squares Mean Difference|-1.2||||0.531|TWO_SIDED|95.0|-3.7|1.3||This p-value corresponds to the difference between treatment groups (ClariVein RES 1% Injection versus ClariVein RES 3% Injection).|ANCOVA|||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||1.3|-3.7|0.531
73990575|NCT03311269|147526587|OTHER||Descriptive (Percentage)|94.4|||||TWO_SIDED|95.0|72.7|99.9|||||The count of the combined treatment group for the elimination of saphenous vein reflux at Week 12 posttreatment is 17/18 (94.4%).|The secondary efficacy endpoint, the elimination of saphenous vein reflux at Week 12 posttreatment, will be summarized for both treatments combined using the count and percentage, together with a 95% Wilson (score) confidence interval for the proportion.||99.9|72.7|
73876144|NCT03985761|147294030|SUPERIORITY|||||||0.121|||||||ANOVA|||||||.121
74035270|NCT00980785|147623128|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-22.5|STANDARD_DEVIATION|78.7||0.836|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.836
73990576|NCT03311269|147526587|OTHER||Percentage Difference|11.1||||1|TWO_SIDED|95.0|-20.5|42.8||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.|Chi-squared|||For elimination of saphenous vein reflux at Week 12 posttreatment, the treatment difference for ClariVein RES 1% Injection versus ClariVein RES 3% Injection for the proportion was assessed by a chi-square test together with a 95% Wilson (score) confidence interval for the treatment difference.||42.8|-20.5|1.000
73990577|NCT01121913|147526588|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|102.0|||||TWO_SIDED|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||114|91.8|
73990578|NCT01121913|147526588|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|105.0|||||TWO_SIDED|90.0|93.9|117.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||117|93.9|
73990579|NCT01121913|147526588|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|95.3|||||TWO_SIDED|90.0|85.5|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||106|85.5|
73990580|NCT01121913|147526588|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|97.7|||||TWO_SIDED|90.0|87.7|109.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||109|87.7|
73990581|NCT01121913|147526589|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|102.0|||||TWO_SIDED|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||114|91.8|
73990582|NCT01121913|147526589|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|106.0|||||TWO_SIDED|90.0|95.1|118.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||118|95.1|
73990583|NCT01121913|147526589|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|94.9|||||TWO_SIDED|90.0|85.1|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||106|85.1|
73990584|NCT01121913|147526589|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|98.4|||||TWO_SIDED|90.0|88.3|110.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||110|88.3|
73990585|NCT01121913|147526590|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|73.3|||||TWO_SIDED|90.0|63.2|85.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||85|63.2|
73990586|NCT01121913|147526590|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|59.8|||||TWO_SIDED|90.0|51.5|69.4|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||69.4|51.5|
73990587|NCT01121913|147526590|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|83.0|||||TWO_SIDED|90.0|71.5|96.4|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||96.4|71.5|
73990588|NCT01121913|147526590|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|67.7|||||TWO_SIDED|90.0|58.4|78.5|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||78.5|58.4|
74035271|NCT00980785|147623128|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-31.71|STANDARD_DEVIATION|90.6||0.836|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.836
74035272|NCT00980785|147623129|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|0.21||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.009
74035273|NCT00980785|147623129|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.63|STANDARD_DEVIATION|0.32||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.009
74035274|NCT00980785|147623130|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|1.56||0.755|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.755
73876145|NCT02648204|147294056|NON_INFERIORITY|Non-Inferiority margin: 0.4|Treatment difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.55|-0.25|||Mixed Models Analysis|||||-0.25|-0.55|<0.0001
74035275|NCT00980785|147623130|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-0.29|STANDARD_DEVIATION|1.23||0.755|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.755
74035276|NCT00980785|147623131|OTHER|Mann-Whitney test|Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|8.9||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.491
74035277|NCT00980785|147623131|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|2.2||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.491
74035278|NCT00922194|147623139|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.36|STANDARD_DEVIATION|3.3|<|0.05||95.0|-9.03|-7.72|||Paired t test|||Analysis of difference between 12 months or more and baseline values||-7.72|-9.03|<0.05
74035279|NCT00922194|147623140|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.27|||<|0.05||95.0|-3.5|-3.0|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months or more and baseline values||-3.0|-3.5|<0.05
74035280|NCT00922194|147623141|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.41|||<|0.05||95.0|-8.37|-6.47|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-6.47|-8.37|<0.05
74035281|NCT00922194|147623142|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.014|||<|0.05||95.0|-0.02|0.001|||Wilcoxon paired sign rank-sum test|||Analysis of difference between 12 months or more and baseline values||0.001|-0.02|<0.05
74035282|NCT00922194|147623143|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.61|||<|0.05||95.0|-5.2|-3.8|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-3.8|-5.2|<0.05
74035283|NCT00922194|147623144|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.97|||<|0.05||95.0|-3.57|-2.38|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-2.38|-3.57|<0.05
74035284|NCT00922194|147623145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.37|||<|0.05||95.0|-2.65|-2.08|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-2.08|-2.65|<0.05
74035285|NCT04131517|147623152|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the least squares (LS) means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|1.0404|||||TWO_SIDED|90.0|0.94156|1.1497||||||The analysis of variance model (ANOVA) included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.1497|0.94156|
74035286|NCT04131517|147623153|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.89272|||||TWO_SIDED|90.0|0.76892|1.0364||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0364|0.76892|
74035287|NCT04131517|147623156|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|1.0276|||||TWO_SIDED|90.0|0.95544|1.1052||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.1052|0.95544|
74035288|NCT04131517|147623157|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL+ OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.88808|||||TWO_SIDED|90.0|0.52185|1.5113||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.5113|0.52185|
73876146|NCT02648204|147294056|SUPERIORITY||Treatment difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.55|-0.25|||Mixed Models Analysis|||||-0.25|-0.55|<0.0001
74035289|NCT04131517|147623164|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.96378|||||TWO_SIDED|90.0|0.85043|1.0922||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0922|0.85043|
74035290|NCT04131517|147623166|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.96842|||||TWO_SIDED|90.0|0.91888|1.0206||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0206|0.91888|
74035291|NCT01757405|147623183|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence of treatment success proportions in all bleeding episodes for the two treatment groups was determined by comparing the 90% two-sided CI of the ratio of success proportions to the equivalence region defined as \[0.83, 1.20\].|Ratio of success proportion|1.21|||||TWO_SIDED|90.0|1.15|1.28|||Ratio of success proportion|||Equivalence test of successfully treated bleeding episodes (BEs) between or within treatment arms. Denoting the success rates in the two treatment groups by p1 and p2 , the null hypotheses of H01 : p1/p2 \< 0.83 and H02 : p1/p2 \> 1.20 was implicitly tested against the one-sided alternatives Ha1: 0.83 ≤ p1/p2 and Ha2 : p1/p2 ≤ 1.20, by comparing the 90% two-sided confidence interval (CI) of the ratio of success proportions to the equivalence region defined as \[0.83, 1.20\].||1.28|1.15|
73876147|NCT02648204|147294056|NON_INFERIORITY|Non-Inferiority margin: 0.04|Treatment difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.57|-0.25|||Mixed Models Analysis|||||-0.25|-0.57|<0.0001
73876148|NCT02648204|147294056|SUPERIORITY||Treatment difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.57|-0.25|||Mixed Models Analysis|||||-0.25|-0.57|<0.0001
73876149|NCT02648204|147294057|SUPERIORITY||Treatment difference|-2.26|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-3.02|-1.51|||Mixed Models Analysis|||||-1.51|-3.02|<0.0001
74035292|NCT01358877|147623208|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0446|TWO_SIDED|95.0|0.66|1.0||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.00|0.66|0.0446
73990589|NCT00935259|147526614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_DEVIATION|52.1||0.455||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||||||0.455
73990590|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.7||||0.014||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 16:00||||0.014
73990591|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 18:3n3||||<0.001
74035293|NCT01358877|147623210|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.043|TWO_SIDED|95.0|0.68|0.99||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.99|0.68|0.0430
73876150|NCT02648204|147294057|SUPERIORITY||Treatment difference|-3.55|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-4.32|-2.78|||Mixed Models Analysis|||||-2.78|-4.32|<0.0001
73876151|NCT01507688|147294088|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED|||||P-value was not adjusted for multiple comparisons. Models adjusted for: VA vs Non Va, admission diagnosis (transient ischemic attack vs stroke), sex (male vs female), white vs nonwhite, and baseline total Stroke Specific Quality of life score.|Mixed Models Analysis|Repeated measurements of change GEE analyses of Total Stroke Specific Quality of Life score change at 6 months from baseline.|The adjusted positive mean (standard error) change at 6 months from baseline was higher in the intervention arm compared to in the control arm. Intervention group had 0.14 (SE 0.17) higher improvement compared to the control group.|"All the sample size calculations were powered at 80% with a 5% Type I error. We estimated based on our pilot study a change difference of 0.25 on Total Stroke Specific Quality of Life in the intervention group compared to no change in the control group at 6 months. Our power calculations estimated a sample of 226 (113) per group was needed to detect this effect. We used primary outcome row Mean Change from 0 to 6 months for this analysis."||||0.0500
73990592|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.217||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n6||||0.217
73990593|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.666||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n9||||0.666
73990594|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.776||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:5n6||||0.776
73990595|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.018||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:6n3||||0.018
73990596|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.152||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Lysophosphatidylcholine 20:4n6||||0.152
73990597|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-132.1||||0.007||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 18:2n6||||0.007
73990598|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8||||0.325||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:3n6||||0.325
73990599|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.3||||0.419||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:4n6||||0.419
73990600|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.07||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n3||||0.070
73990601|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.769||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n6||||0.769
74035294|NCT01358877|147623212|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0327|TWO_SIDED|95.0|0.67|0.98||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.98|0.67|0.0327
73990602|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylethanolamine 18:2n6||||<0.001
73990603|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-240.8||||0.016||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 16:00||||0.016
73990604|NCT00935259|147526615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.833||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 20:3n9||||0.833
73990605|NCT00935259|147526616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.027||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fasted||||0.027
73990606|NCT00935259|147526616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fed||||<0.001
73990607|NCT00935259|147526618|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Mixed Models Analysis|||Cholesterol ester c20:4n6 / c20:3n6||||0.247
74035295|NCT01358877|147623214|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.4673|TWO_SIDED|95.0|0.66|1.21||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.21|0.66|0.4673
73990608|NCT00935259|147526618|SUPERIORITY_OR_OTHER|||||||0.151||95.0|||||Mixed Models Analysis|||Cholesterol ester c20:5n3 / c20:4n3||||0.151
73990609|NCT00874497|147526640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0824||||0.1761|TWO_SIDED|95.0|-0.0378|0.2025||P-values are based on Analysis of Covariance (ANCOVA) model of the change FEV1 from baseline to the specified study week using treatment group and current smoking status as fixed effects and the baseline FEV1 value as a covariate.|ANCOVA|||Statistical analysis at Week 104.||0.2025|-0.0378|0.1761
73990610|NCT00874497|147526641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.904||||0.139|TWO_SIDED|95.0|-6.77|0.97|||ANCOVA|||Statistical analysis of Right Upper region of the lung at Week 104.||0.97|-6.77|0.139
73990611|NCT00874497|147526641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.46|TWO_SIDED|95.0|-4.46|2.04|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.||2.04|-4.46|0.460
73990612|NCT00874497|147526641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.176||||0.457|TWO_SIDED|95.0|-7.98|3.63|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.||3.63|-7.98|0.457
73990613|NCT00874497|147526641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.167||||0.362|TWO_SIDED|95.0|-6.88|2.54|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.||2.54|-6.88|0.362
73990614|NCT00874497|147526641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.225||||0.67|TWO_SIDED|95.0|-6.94|4.48|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.||4.48|-6.94|0.670
73990615|NCT00874497|147526641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.218||||0.244|TWO_SIDED|95.0|-5.98|1.55|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.||1.55|-5.98|0.244
73990616|NCT00874497|147526641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.374||||0.574|TWO_SIDED|95.0|-6.23|3.48|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.||3.48|-6.23|0.574
73990617|NCT00874497|147526643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97||||0.436|TWO_SIDED|95.0|-1.53|3.47|||ANCOVA|||Statistical analysis of Right Upper region of the Lung at Week 104.||3.47|-1.53|0.436
73990618|NCT00874497|147526643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31||||0.067|TWO_SIDED|95.0|-0.17|4.79|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.||4.79|-0.17|0.067
73990619|NCT00874497|147526643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97||||0.163|TWO_SIDED|95.0|-0.83|4.77|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.||4.77|-0.83|0.163
73990620|NCT00874497|147526643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27||||0.102|TWO_SIDED|95.0|-0.48|5.02|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.||5.02|-0.48|0.102
73990621|NCT00874497|147526643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11||||0.162|TWO_SIDED|95.0|-0.89|5.12|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.||5.12|-0.89|0.162
73990622|NCT00874497|147526643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.16|TWO_SIDED|95.0|-0.73|4.29|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.||4.29|-0.73|0.160
73990623|NCT00874497|147526643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.08||||0.122|TWO_SIDED|95.0|-0.58|4.75|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.||4.75|-0.58|0.122
73990624|NCT00874497|147526643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05||||0.106|TWO_SIDED|95.0|-0.46|4.56|||ANCOVA|||Statistical analysis of Whole Lung region of the Lung at Week 104.||4.56|-0.46|0.106
73990625|NCT00874497|147526644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.423||||0.469|TWO_SIDED|95.0|-5.32|2.48|||ANCOVA|||LS Mean Difference between Tetomilast and Placebo at Week 104.||2.48|-5.32|0.469
73990626|NCT00874497|147526645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.519|TWO_SIDED|95.0|-4.42|2.27|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.||2.27|-4.42|0.519
73990627|NCT00874497|147526645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.463|TWO_SIDED|95.0|-3.92|1.82|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104.||1.82|-3.92|0.463
73990628|NCT00874497|147526645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.598|TWO_SIDED|95.0|-6.74|3.94|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104.||3.94|-6.74|0.598
73876152|NCT01507688|147294088|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.04||0.26|TWO_SIDED|||||Adjusted least square means (standard errors) adjusted for treatment (Intervention vs control), time of outcome from baseline (3, 6, 12 months), baseline SSQoL, Site (VA vs NonVA), Stroke/TIA diagnosis, sex (m vs f) and race (white vs nonwhite).|Mixed Models Analysis||Adjusted intervention arm's positive change (regression coefficient with standard error) in Total Stroke Specific Quality of Life was not significantly different at 12 months compared to the control group.|"We evaluated the mean difference on Total Stroke Specific Quality of Life compared to baseline between the intervention and control groups at 12 months using repeated measures ANCOVA models. We used primary outcome row Mean change from 0 to 12 months for this analysis."||||0.26
73876153|NCT02341235|147294089|SUPERIORITY|||||||0.35|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.35
73876154|NCT02341235|147294090|SUPERIORITY|||||||0.22|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||0.22
73876155|NCT02341235|147294091|SUPERIORITY|||||||0.97|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.97
73876156|NCT02341235|147294092|SUPERIORITY|||||||0.98|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.98
73990629|NCT00874497|147526645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.94||||0.142|TWO_SIDED|95.0|-6.92|1.03|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.||1.03|-6.92|0.142
73990630|NCT00874497|147526645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.757|TWO_SIDED|95.0|-6.26|4.59|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.||4.59|-6.26|0.757
73990631|NCT00874497|147526645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||0.5|TWO_SIDED|95.0|-5.03|2.5|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.||2.50|-5.03|0.500
73990632|NCT00874497|147526645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||0.353|TWO_SIDED|95.0|-6.09|2.23|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.||2.23|-6.09|0.353
73990633|NCT00874497|147526645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.438|TWO_SIDED|95.0|-5.43|2.4|||ANCOVA|||Statistical analysis of whole region of the lung at Week 104.||2.40|-5.43|0.438
73876157|NCT02341235|147294093|SUPERIORITY|||||||0.83|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.83
73876158|NCT02341235|147294094|SUPERIORITY|||||||0.055|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.055
73876159|NCT02341235|147294095|SUPERIORITY|||||||0.71|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.71
73990634|NCT00874497|147526646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|351487.0||||0.22|TWO_SIDED|95.0|-219976.0|922951.0|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.||922951|-219976|0.220
73990635|NCT00874497|147526646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|103036.0||||0.146|TWO_SIDED|95.0|-37651.0|243723.0|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104||243723|-37651|0.146
73990636|NCT00874497|147526646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|247358.0||||0.322|TWO_SIDED|95.0|-252728.0|747444.0|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104||747444|-252728|0.322
73990637|NCT00874497|147526646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|362384.0||||0.141|TWO_SIDED|95.0|-126518.0|851286.0|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.||851286|-126518|0.141
73990638|NCT00874497|147526646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|294202.0||||0.325|TWO_SIDED|95.0|-303329.0|891733.0|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.||891733|-303329|0.325
73990639|NCT00874497|147526646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|575882.0||||0.258|TWO_SIDED|95.0|-439692.0|1591457.0|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.||1591457|-439692|0.258
73990640|NCT00874497|147526646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|589373.0||||0.247|TWO_SIDED|95.0|-426928.0|1605673.0|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.||1605673|-426928|0.247
73990641|NCT00874497|147526646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1156318.0||||0.251|TWO_SIDED|95.0|-855009.0|3167645.0|||ANCOVA|||Statistical analysis of whole lung region of the lung at Week 104.||3167645|-855009|0.251
73990642|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.9||||0.181|TWO_SIDED|95.0|-38.0|193.8|||ANCOVA|||Statistical analysis of right upper lung region (RV) at Week 104.||193.8|-38.0|0.181
73990643|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.781|TWO_SIDED|95.0|-48.8|36.9|||ANCOVA|||Statistical analysis of right middle lung region (RV) at Week 104.||36.9|-48.8|0.781
73990644|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.7||||0.445|TWO_SIDED|95.0|-77.8|173.2|||ANCOVA|||Statistical analysis of right lower lung region (RV) at Week 104.||173.2|-77.8|0.445
73990645|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.6||||0.259|TWO_SIDED|95.0|-48.1|173.2|||ANCOVA|||Statistical analysis of left upper lung region (RV) at Week 104.||173.2|-48.1|0.259
73990646|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0||||0.639|TWO_SIDED|95.0|-105.6|169.6|||ANCOVA|||Statistical analysis of left lower lung region (RV) at Week 104.||169.6|-105.6|0.639
73990647|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|102.3||||0.408|TWO_SIDED|95.0|-145.9|350.5|||ANCOVA|||Statistical analysis of right whole lung region (RV) at Week 104.||350.5|-145.9|0.408
73990648|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85.2||||0.445|TWO_SIDED|95.0|-138.8|309.2|||ANCOVA|||Statistical analysis of left whole lung region (RV) at Week 104.||309.2|-138.8|0.445
73990649|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|187.6||||0.421|TWO_SIDED|95.0|-279.6|654.8|||ANCOVA|||Statistical analysis of whole lung region (RV) at Week 104.||654.8|-279.6|0.421
73876160|NCT02341235|147294096|SUPERIORITY|||||||0.33|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.33
73876161|NCT02341235|147294097|SUPERIORITY|||||||0.94|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.94
73876162|NCT02341235|147294098|SUPERIORITY|||||||0.57|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.57
73990650|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.7||||0.353|TWO_SIDED|95.0|-58.5|159.9|||ANCOVA|||Statistical analysis of right upper lung region (TLC) at Week 104.||159.9|-58.5|0.353
74035296|NCT01358877|147623216|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.043|TWO_SIDED|95.0|0.63|0.99|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.99|0.63|0.0430
74035297|NCT01358877|147623218|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.1007|TWO_SIDED|95.0|0.64|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.04|0.64|0.1007
73990651|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9||||0.66|TWO_SIDED|95.0|-35.3|55.0|||ANCOVA|||Statistical analysis of right middle lung region (TLC) at Week 104.||55.0|-35.3|0.660
73990652|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7||||0.859|TWO_SIDED|95.0|-110.7|132.1|||ANCOVA|||Statistical analysis of right lower lung region (TLC) at Week 104.||132.1|-110.7|0.859
73990653|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.5||||0.253|TWO_SIDED|95.0|-38.4|141.4|||ANCOVA|||Statistical analysis of left upper lung region (TLC)at Week 104.||141.4|-38.4|0.253
73990654|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.3||||0.754|TWO_SIDED|95.0|-126.0|172.6|||ANCOVA|||Statistical analysis of left lower lung region (TLC) at Week 104.||172.6|-126.0|0.754
73990655|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.2||||0.546|TWO_SIDED|95.0|-145.1|269.5|||ANCOVA|||Statistical analysis of right whole lung region (TLC) at Week 104.||269.5|-145.1|0.546
73990656|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.9||||0.554|TWO_SIDED|95.0|-155.5|285.3|||ANCOVA|||Statistical analysis of left whole lung region (TLC) at Week 104.||285.3|-155.5|0.554
74035298|NCT01358877|147623220|SUPERIORITY||Treatment Difference|0.4|||||TWO_SIDED|95.0|0.0|0.8|||||The difference in percentage of participants with a primary cardiac event between the pertuzumab and placebo arms. The 95% confidence interval (CI) was estimated using Hauck-Anderson correction.|||0.8|0.0|
74035299|NCT01358877|147623221|SUPERIORITY||Treatment Difference|-0.1|||||TWO_SIDED|95.0|-1.0|0.9|||||95% CI was estimated using Hauck-Anderson correction.|||0.9|-1.0|
73876163|NCT02341235|147294099|SUPERIORITY|||||||0.3|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.30
73990657|NCT00874497|147526647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|132.2||||0.524|TWO_SIDED|95.0|-284.9|549.4|||ANCOVA|||Statistical analysis of whole lung region (TLC) at Week 104.||549.4|-284.9|0.524
73990658|NCT00874497|147526648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5843|TWO_SIDED|95.0|-0.07|0.04|||ANCOVA|||||0.04|-0.07|0.5843
73990659|NCT00874497|147526649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249||||0.1252|TWO_SIDED|95.0|-0.073|0.571|||ANCOVA|||||0.571|-0.073|0.1252
73990660|NCT00874497|147526650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1835||||0.4661|TWO_SIDED|95.0|-0.6892|0.3221|||ANCOVA|||||0.3221|-0.6892|0.4661
73990661|NCT00874497|147526651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.134|TWO_SIDED|95.0|-0.19|1.4|||ANCOVA|||||1.40|-0.19|0.134
73990662|NCT00874497|147526652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.074|TWO_SIDED|95.0|-1.5|0.07|||ANCOVA|||Statistical analysis for sRaw||0.07|-1.50|0.074
74035300|NCT01358877|147623222|SUPERIORITY||Treatment Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||95% CI was estimated using Hauck-Anderson correction.|||0.5|-0.3|
74035301|NCT03575884|147623253|SUPERIORITY||Study_arm timepoint interactions|-27.32|||<|0.05|TWO_SIDED|95.0|-52.49|-2.14|||Mixed Models Analysis|||||-2.14|-52.49|<0.05
73990663|NCT00874497|147526652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.155|TWO_SIDED|95.0|-0.09|0.52|||ANCOVA|||Statistical analysis for sGaw||0.52|-0.09|0.155
73990664|NCT00874497|147526653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.845|TWO_SIDED|95.0|-0.77|0.64|||ANCOVA|||Statistical analysis for mean prior daily breath symptoms||0.64|-0.77|0.845
73990665|NCT00874497|147526653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.549|TWO_SIDED|95.0|-0.52|0.94|||ANCOVA|||Statistical analysis for mean prior daily cough symptoms||0.94|-0.52|0.549
73990666|NCT00874497|147526653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.717|TWO_SIDED|95.0|-0.93|0.65|||ANCOVA|||Statistical analysis for mean prior daily sputum symptoms||0.65|-0.93|0.717
73990667|NCT00874497|147526655|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Statistical analysis for level I (self management) at week 104.||||1.000
73990668|NCT00874497|147526655|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Statistical analysis for level II (physician visit) at week 104.||||1.0000
73990669|NCT00874497|147526655|SUPERIORITY_OR_OTHER|||||||0.5092|||||||Fisher Exact|||Statistical analysis for level III (hospital visit) at week 104.||||0.5092
73990670|NCT00874497|147526656|SUPERIORITY_OR_OTHER|||||||0.63||||||Fisher's Exact test was used to determine whether the tetomilast and placebo groups differ in the proportion of participants who experienced Level 2 or higher COPD exacerbations during the study.|Fisher Exact|||Statistical analysis at Week 104||||0.630
74035302|NCT04322994|147623267|OTHER|||||||0.18||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with any desaturation event.||||0.18
74035303|NCT04322994|147623267|OTHER|||||||0.26||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 desaturation event versus 2 or more events.||||0.26
74035304|NCT04322994|147623268|OTHER|||||||0.26||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with at any qualifying desaturation event.||||0.26
73876164|NCT02341235|147294100|SUPERIORITY|||||||0.44|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.44
73876165|NCT02341235|147294101|SUPERIORITY|||||||0.62|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.62
73876166|NCT02341235|147294102|SUPERIORITY|||||||0.7|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.70
73990671|NCT04353817|147526661|SUPERIORITY||Least Squares (LS) Mean Difference|-2.26|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.81|||Mixed-effects Model for Repeated Measure|||||-1.81|-2.71|<0.0001
73990672|NCT04353817|147526662|SUPERIORITY||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-55.3|-47.1||This is the nominal p-value without multiplicity controlled.|Mixed-effects Model for Repeated Measure|||||-47.1|-55.3|<0.0001
73990673|NCT00239681|147526664|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56|||<|0.0001||95.0|0.46|0.69|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.69|0.46|<0.0001
73990674|NCT00239681|147526665|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||<|0.021||95.0|0.67|0.97|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.97|0.67|<0.021
73990675|NCT00239681|147526666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.172||95.0|0.65|1.08|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.08|0.65|<0.172
73990676|NCT00239681|147526667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27|||<|0.015||95.0|1.05|1.53|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.53|1.05|<0.015
73990677|NCT00239681|147526668|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.018||95.0|0.35|0.91|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.91|0.35|0.018
73990678|NCT00239681|147526669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.548||95.0|0.88|1.28|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.28|0.88|0.548
73990679|NCT03599622|147526694|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|4.3||||0.5812|TWO_SIDED|95.0|-11.0|19.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||19.5|-11.0|0.5812
73990680|NCT03599622|147526694|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.2||||0.5812|TWO_SIDED|95.0|0.6|2.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||2.5|0.6|0.5812
73990681|NCT03599622|147526694|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-6.3||||0.372|TWO_SIDED|95.0|-20.2|7.6||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||7.6|-20.2|0.3720
73990682|NCT03599622|147526694|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|0.7||||0.372|TWO_SIDED|95.0|0.3|1.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.5|0.3|0.3720
73990683|NCT03599622|147526695|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|15.0||||0.0198|TWO_SIDED|95.0|3.7|26.3||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||26.3|3.7|0.0198
73990684|NCT03599622|147526695|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|3.4||||0.0198|TWO_SIDED|95.0|1.2|9.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||9.8|1.2|0.0198
73990685|NCT03599622|147526695|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|8.2||||0.1584|TWO_SIDED|95.0|-2.6|19.0||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||19.0|-2.6|0.1584
73990686|NCT03599622|147526695|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|2.1||||0.1584|TWO_SIDED|95.0|0.7|6.1||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||6.1|0.7|0.1584
73990687|NCT03599622|147526696|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|7.7||||0.3464|TWO_SIDED|95.0|-8.2|23.6||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||23.6|-8.2|0.3464
73990688|NCT03599622|147526696|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.4||||0.3464|TWO_SIDED|95.0|0.7|2.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||2.8|0.7|0.3464
73990689|NCT03599622|147526696|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-1.2||||0.8857|TWO_SIDED|95.0|-17.0|14.7||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||14.7|-17.0|0.8857
73990690|NCT03599622|147526696|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.0||||0.8857|TWO_SIDED|95.0|0.5|1.9||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.9|0.5|0.8857
73876167|NCT02341235|147294103|SUPERIORITY|||||||0.41|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.41
74035305|NCT04322994|147623268|OTHER|||||||0.08||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 qualifying desaturation event versus 2 or more qualifying events.||||0.08
74035306|NCT04322994|147623269|OTHER|||||||0.28|||||||Chi-squared|||Analysis of between-group difference for participants with any qualifying event.||||0.28
74035307|NCT04322994|147623269|OTHER|||||||0.38||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|||Analysis of between-group difference for participants with 1 qualifying event versus 2 or more events.||||0.38
74035308|NCT04322994|147623270|OTHER|||||||0.88||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Analysis of between-group difference for participants with at any qualifying desaturation event.||||0.88
74035309|NCT04322994|147623271|OTHER|||||||0.14||||||The a priori threshold for statistical significance was 0.05.|Chi-squared, Corrected|Chi-squared test of independence||Analysis of between-group difference for participants with any surgical interruption.||||0.14
74035310|NCT04322994|147623271|OTHER|||||||0.21||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 surgical interruption versus 2 or more interruptions.||||0.21
74035311|NCT03664193|147623278|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 37.5 Gy.|Proportion (percent)|30.0|||||TWO_SIDED|95.0|14.7|49.3||||||||49.3|14.7|
74035312|NCT03664193|147623278|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 40.0 Gy.|Proportion (percent)|46.7|||||TWO_SIDED|95.0|28.3|65.7||||||||65.7|28.3|
74035313|NCT03664193|147623278|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 42.5 Gy.|Proportion (percent)|6.7|||||TWO_SIDED|95.0|0.8|22.1||||||||22.1|0.8|
74035314|NCT03664193|147623278|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 45.0 Gy.|Proportion (percent)|16.7|||||TWO_SIDED|95.0|5.6|34.7||||||||34.7|5.6|
74035315|NCT03664193|147623279|OTHER|Simple proportion and exact 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|88.4|100.0||||||||100.0|88.4|
74035316|NCT02345252|147623283|NON_INFERIORITY|A sample size of 275 HIV-1 infected participants per treatment group would provide 85% power to detect a noninferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and FTC/RPV/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-0.3|||||TWO_SIDED|95.001|-4.2|3.7|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the FTC/RPV/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the FTC/RPV/TDF group.||3.7|-4.2|
74035317|NCT02345252|147623283|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
74035318|NCT04507867|147623293|OTHER|Kaplan-Meier method for overall survival.||||||0.027|||||||Log Rank|||The total number of patients who did or did not survive to day 40 of follow-up.||||0.027
73876168|NCT02341235|147294104|SUPERIORITY|||||||0.72|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.72
73876169|NCT02341235|147294111|SUPERIORITY|||||||0.084|||||||ANCOVA|||||||0.084
73876170|NCT02341235|147294113|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.580
73876171|NCT02341235|147294121|SUPERIORITY|||||||0.461|||||||ANCOVA|||||||0.461
73876172|NCT02341235|147294123|SUPERIORITY|||||||0.934|||||||ANCOVA|||||||0.934
74035319|NCT04507867|147623295|OTHER|Kaplan-Meier method||||||0.495|||||||Log Rank|||the total number of patients who were intubated and survived at the end of day 40 follow-up.||||0.495
74035320|NCT04507867|147623297|OTHER|Kaplan-Meier method||||||0.186|||||||Log Rank|||total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay.||||0.186
74035321|NCT04507867|147623298|SUPERIORITY|Fisher exact test||||||0.35|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay. It was categorized as follows: 1. normal bristol scale at day 3; 2. abnormal bristol scale at day 3.||||0.35
74035322|NCT04507867|147623299|SUPERIORITY|||||||0.043|||||||t-test, 1 sided|||Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay . Deceased patients were excluded.||||0.043
74035323|NCT04507867|147623300|SUPERIORITY|||||||0.241|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay . Deceased patients were excluded.||||0.241
74035324|NCT04507867|147623301|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|||Intragroup analysis at the control group, the measurement was performed at baseline and at hospital discharge.||||0.187
74035325|NCT04507867|147623301|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Intragroup analysis at the intervention group, the measurement was performed at baseline and at hospital discharge.||||0.003
74035326|NCT04507867|147623302|SUPERIORITY|||||||0.919|||||||t-test, 2 sided|||Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.||||0.919
74035327|NCT04507867|147623302|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.||||0.014
73876173|NCT02163824|147294125|SUPERIORITY||Difference in % of responders|16.1||||0.0024|TWO_SIDED|95.0|5.9|26.4|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||26.4|5.9|.0024
73990691|NCT03599622|147526697|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|8.1||||0.2841|TWO_SIDED|95.0|-6.7|22.9||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||22.9|-6.7|0.2841
73990692|NCT03599622|147526697|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.5||||0.2841|TWO_SIDED|95.0|0.7|3.1||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||3.1|0.7|0.2841
73876174|NCT02163824|147294125|SUPERIORITY||Difference in % of responders|22.1|||<|0.0001|TWO_SIDED|95.0|11.7|32.6|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||32.6|11.7|<.0001
73990693|NCT03599622|147526697|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-4.2||||0.5417|TWO_SIDED|95.0|-17.6|9.2||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||9.2|-17.6|0.5417
73990694|NCT03599622|147526697|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|0.8||||0.5417|TWO_SIDED|95.0|0.3|1.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.8|0.3|0.5417
73876175|NCT02163824|147294126|SUPERIORITY||Difference in % of responders|19.5||||0.0019|TWO_SIDED|95.0|7.4|31.5|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||31.5|7.4|.0019
73990695|NCT03599622|147526698|EQUIVALENCE|Mean Change From Baseline|Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-4.3|-1.8|||ANCOVA|||||-1.8|-4.3|
73990696|NCT03599622|147526698|SUPERIORITY|Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.92||0.0428|TWO_SIDED|95.0|-3.7|-0.1||Based on a 2-sided test at a significance level of 0.025.|ANCOVA||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||-0.1|-3.7|0.0428
73990697|NCT03599622|147526698|EQUIVALENCE|Mean Change from Baseline|Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-4.8|-2.0|||ANCOVA|||||-2.0|-4.8|
73990698|NCT03599622|147526698|SUPERIORITY|Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.|Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.95||0.0177|TWO_SIDED|95.0|-4.1|-0.4||Based on a 2-sided test at a significance level of 0.025.|ANCOVA||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||-0.4|-4.1|0.0177
73990699|NCT03599622|147526698|EQUIVALENCE|Mean Change From Baseline|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.6|0.3||||||||0.3|-2.6|
73990700|NCT03599622|147526698|EQUIVALENCE|Mean Change from Baseline|Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-9.7|-2.3|||ANCOVA|||||-2.3|-9.7|
73990701|NCT00665223|147526705|SUPERIORITY|This analysis compared ACR16 45 mg vs. placebo during the randomization phase.|Mean Difference (Final Values)|-0.36||||0.456|TWO_SIDED|97.5|-1.44|0.72|||ANCOVA|||The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.||0.72|-1.44|0.456
73990702|NCT00665223|147526705|SUPERIORITY|This analysis compared ACR16 90 mg vs. placebo during the randomization phase.|Mean Difference (Final Values)|-0.99||||0.042|TWO_SIDED|97.5|-2.08|0.1|||ANCOVA|||The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.||0.10|-2.08|0.042
73990703|NCT00002597|147526713|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.0309|TWO_SIDED|95.0|1.01|1.35|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Null hypothesis: 8-year OS rate of 60% radiation therapy (RT) alone vs. 67% with hormone therapy. The study was designed with 90% power to detect a 7-percentage- point absolute difference in the 8-year survival rate, with the use of a one-sided log-rank test at the 0.025 significance level, requiring 1980 patients and 716 deaths for definitive analysis.||1.35|1.01|0.0309
73990704|NCT00002597|147526714|SUPERIORITY||Hazard Ratio (HR)|1.86||||0.001|TWO_SIDED|95.0|1.27|2.74|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.74|1.27|0.001
73990705|NCT00002597|147526715|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.0013|TWO_SIDED|95.0|1.17|1.93|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||1.93|1.17|0.0013
73990706|NCT00002597|147526716|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.035|TWO_SIDED|95.0|1.03|2.06|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.06|1.03|0.035
74035328|NCT04507867|147623303|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||Intragroup analysis of the control group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.||||0.608
73990707|NCT00002597|147526717|SUPERIORITY||Hazard Ratio (HR)|1.74|||<|0.001|TWO_SIDED|95.0|1.48|2.04|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.04|1.48|<0.001
73990708|NCT00002597|147526718|SUPERIORITY||Hazard Ratio (HR)|1.5|||<|0.001|TWO_SIDED|95.0|1.21|1.85|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||1.85|1.21|<0.001
73990709|NCT00002597|147526719|SUPERIORITY||Hazard Ratio (HR)|2.06|||<|0.001|TWO_SIDED|95.0|1.34|3.16|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||3.16|1.34|<0.001
73990710|NCT00002597|147526720|SUPERIORITY||Hazard Ratio (HR)|1.38|||<|0.001|TWO_SIDED|95.0|1.22|1.56|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Treatment arms were compared using the log-rank test (one-sided significance level of 0.025).||1.56|1.22|<0.001
73990711|NCT00002597|147526721|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73990712|NCT02485899|147526723|OTHER||Hazard Ratio (HR)|0.14|||<|0.0001|TWO_SIDED|95.0|0.06|0.33|||Cox Proportional Hazards model|||||0.33|0.06|<0.0001
73990713|NCT02485899|147526724|OTHER||Hazard Ratio (HR)|0.01|||<|0.0001|TWO_SIDED||||||Cox Proportional Hazards model|||||||<0.0001
73990714|NCT00623363|147526773|SUPERIORITY|||||||0.503|||||||Monte Carlo estimates|||Baseline (Day -7)||||0.503
73990715|NCT00623363|147526773|SUPERIORITY||Least Squares (LS) Mean|20.6|||||TWO_SIDED|95.0|1.82|39.37||||||Average of Days 1 and 2||39.37|1.82|
73990716|NCT00623363|147526773|SUPERIORITY||Least Squares (LS) Mean|3.6|||||TWO_SIDED|95.0|-15.18|22.37||||||Change from Baseline||22.37|-15.18|
73990717|NCT00623363|147526773|SUPERIORITY||Least Squares (LS) Mean|36.59|||||TWO_SIDED|95.0|24.04|49.14||||||Average of Days 1 and 2||49.14|24.04|
73990718|NCT00623363|147526773|SUPERIORITY||Least Squares (LS) Mean|19.59||||0.16|TWO_SIDED|95.0|7.04|32.14|||ANCOVA|||Change from Baseline||32.14|7.04|0.160
73990719|NCT00823836|147526792|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of ropinirole PR/XR tablets to ropinirole IR tablets was assessed with a non-inferiority margin of 2.5.|Median Difference (Net)|0.34||||0.702|TWO_SIDED|95.0|-1.41|2.09||Analysis of covariance (ANCOVA) model: value of change from Week 0 at Week 24 = treatment group + Week 0 value|ANCOVA|||||2.09|-1.41|0.702
73990720|NCT02271230|147526854|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.78|1.11||||||||1.11|0.78|
73990721|NCT02271230|147526854|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.8|1.14||||||||1.14|0.80|
73990722|NCT02271230|147526855|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.81|1.09||||||||1.09|0.81|
73990723|NCT02271230|147526855|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.74|0.998||||||||0.998|0.74|
73990724|NCT02725528|147526856|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
73990725|NCT02725528|147526857|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
73876176|NCT02163824|147294126|SUPERIORITY||Difference in % of responders|22.5||||0.0003|TWO_SIDED|95.0|10.6|34.4|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||34.4|10.6|.0003
73876177|NCT02163824|147294127|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0007|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 8.|||||0.0007
73990726|NCT02725528|147526858|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
73990727|NCT02725528|147526859|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
73990728|NCT02725528|147526860|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
73990729|NCT02725528|147526861|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
74035329|NCT04507867|147623303|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Intragroup analysis of the intervention group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.||||0.04
74035330|NCT04507867|147623304|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Intergroup analysis between both groups to evaluate the number of defecations measured at day 3.||||0.014
73990730|NCT02725528|147526862|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
73990731|NCT02725528|147526863|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
73990732|NCT02725528|147526864|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
73990733|NCT03042299|147526868|EQUIVALENCE|The difference in the least square (LS) means between formulations (TAK-536 pediatric formulation \[granules\]-TAK-536 commercial formulation \[tablet\]) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included log-transformed (natural log) PK parameters AUC 48 as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0731|||||TWO_SIDED|90.0|-0.1088|-0.0373||||||||-0.0373|-0.1088|
73990734|NCT03042299|147526869|EQUIVALENCE|The difference in the LS means between formulations (TAK-536 pediatric formulation \[granules\]-TAK-536 commercial formulation \[tablet\]) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0909|||||TWO_SIDED|90.0|-0.1573|-0.0244||||||||-0.0244|-0.1573|
73990735|NCT04211389|147526891|SUPERIORITY||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.17|13.7||Stratification by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|IGA Success at Week 8 Odds Ratio||13.70|3.17|<0.0001
73990736|NCT04211389|147526892|SUPERIORITY||Hazard Ratio (HR)|4.207|||<|0.0001|TWO_SIDED|95.0|3.029|5.844|||Log Rank|Unstratified log-rank test|HR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization.|Time to Achieve PASI-50||5.844|3.029|<0.0001
73990737|NCT04211389|147526893|SUPERIORITY||Odds Ratio (OR)|10.42|||<|0.0001|TWO_SIDED|95.0|4.49|24.19|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-75 at Week 8 Odds Ratio||24.19|4.49|<0.0001
73990738|NCT04211389|147526894|SUPERIORITY||Odds Ratio (OR)|8.51||||0.0002|TWO_SIDED|95.0|2.45|28.86|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-90 at Week 8 Odds Ratio||28.86|2.45|0.0002
73990739|NCT04211389|147526895|SUPERIORITY||Odds Ratio (OR)|11.18||||0.0004|TWO_SIDED|95.0|2.33|53.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Success at Week 8 Odds Ratio||53.68|2.33|0.0004
73990740|NCT04211389|147526896|SUPERIORITY||Odds Ratio (OR)|15.27||||0.0002|TWO_SIDED|95.0|3.1|75.35|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA with multiple imputation of missing data.|I-IGA Clear at Week 8 Odds Ratio||75.35|3.10|0.0002
73990741|NCT04211389|147526897|SUPERIORITY|WI-NRS Success at Week 2 Odds Ratio|Odds Ratio (OR)|2.56||||0.0026|TWO_SIDED|95.0|1.43|4.58|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||4.58|1.43|0.0026
73990742|NCT04211389|147526897|SUPERIORITY|WI-NRS Success at Week 4 Odds Ratio|Odds Ratio (OR)|4.93|||<|0.0001|TWO_SIDED|95.0|2.65|9.18|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||9.18|2.65|<0.0001
73990743|NCT04211389|147526897|SUPERIORITY|WI-NRS Success at Week 8 Odds Ratio|Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.07|6.23|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||6.23|2.07|<0.0001
73990744|NCT04211389|147526898|SUPERIORITY||Mean Difference (Final Values)|-26.0|||<|0.0001|TWO_SIDED|95.0|-31.9|-20.0|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|LS Mean Difference at Week 4||-20.0|-31.9|<0.0001
74035331|NCT04507867|147623305|SUPERIORITY|||||||0.008|||||||Fisher Exact|the shapiro wilk test was used to analyze the distribution of the data.||Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay. Deceased patients were excluded.||||0.008
73876178|NCT02163824|147294127|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.044|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean grade AC at Day 8.|||||0.0440
73990745|NCT04211389|147526898|SUPERIORITY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-33.2|-19.7|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|LS Mean Difference at Week 8||-19.7|-33.2|<0.0001
73990746|NCT02357264|147526934|OTHER|||||||0.162|||||||Fisher Exact|||||||.162
73990747|NCT01062971|147526935|NON_INFERIORITY|Noninferiority was determined if the treatments did not show differences greater than 20%||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73990748|NCT01062971|147526936|NON_INFERIORITY|Noninferiority was determined if the treatments did not show differences greater than 20%.|||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73990749|NCT01161628|147526964|SUPERIORITY_OR_OTHER||||||<|0.5|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: p (CR rate) is 0.5 or less versus... Alternative hypothesis: p \>0.5 A sample size of 25 patients gives 90% power with an alpha = 0.05||||<0.5
73990750|NCT00097669|147527004|SUPERIORITY|"We used Kaplan-Meier methods to construct cumulative time-to-event curves for the two groups, with a comparison by use of the log-rank test.~We used a Cox proportional hazard model analysis to control for any potential imbalance in baseline characteristics and follow-up between the two groups."|Risk Ratio (RR)|0.91||||0.05|TWO_SIDED|95.0|0.82|1.0|||Log Rank|||||1.00|0.82|0.05
73990751|NCT00097669|147527004|SUPERIORITY||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.81|1.0|||Regression, Cox|Analysis before adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.||||1.00|0.81|<0.05
73990752|NCT00097669|147527004|SUPERIORITY||Hazard Ratio (HR)|0.91|||<|0.05|TWO_SIDED|95.0|0.81|1.03|||Regression, Cox|Analysis after adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.||||1.03|0.81|<0.05
73990753|NCT02330276|147527016|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
73990754|NCT02330276|147527017|OTHER|one way ANOVA between groups|Mean Difference (Final Values)|77.9|STANDARD_DEVIATION|11.9|<|0.05|TWO_SIDED|95.0|70.3|85.5||for change in heart rate at 24 hr post-dosing from baseline between the 3 doses|ANOVA|||Primary hypothesis: None of the doses of (+)-epicatechin will differ with regard to change from baseline in any of the major safety endpoints; heart rate, systolic and diastolic blood pressure.||85.5|70.3|<0.05
73990755|NCT02330276|147527018|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
73990756|NCT02330276|147527019|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
73990757|NCT02330276|147527020|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
73990758|NCT04486313|147527074|SUPERIORITY|||||||0.8786|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.8786
73876179|NCT02163824|147294128|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.0391|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 15.|||||0.0391
73990759|NCT04486313|147527075|SUPERIORITY|||||||0.074||||||Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness|Cochran-Mantel-Haenszel|||||||0.0740
73990760|NCT04486313|147527076|SUPERIORITY|||||||0.4479|||||||Cochran-Mantel-Haenszel|||Comparison of proportion positive for SARS-CoV-2 at Day 4||||0.4479
73876180|NCT02163824|147294128|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.1811|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 15.|||||0.1811
73876181|NCT02163824|147294129|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.1953|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean ocular pain grade at Day 8.|||||0.1953
73990761|NCT04486313|147527076|SUPERIORITY|||||||0.2814|||||||Cochran-Mantel-Haenszel|||Comparison of proportion positive for SARS-CoV-2 at Day 10||||0.2814
73990762|NCT04486313|147527077|SUPERIORITY|||||||0.0665|||||||t-test, 2 sided|||Comparison of change from Baseline to Day 4||||0.0665
73990763|NCT04486313|147527077|SUPERIORITY|||||||0.4974|||||||t-test, 2 sided|||Comparison of change from Baseline to Day 10||||0.4974
73990764|NCT04486313|147527078|SUPERIORITY|||||||0.1771|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.1771
73990765|NCT04486313|147527079|SUPERIORITY|||||||0.2399|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.2399
73990766|NCT04486313|147527080|SUPERIORITY|||||||0.09|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.09
73990767|NCT04486313|147527081|SUPERIORITY|||||||0.0077|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.0077
73990768|NCT04486313|147527082|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.05
73990769|NCT04486313|147527083|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.05
73990770|NCT04486313|147527084|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.08
73990771|NCT01657799|147527085|SUPERIORITY|||||||0.933|||||||Log Rank|Log-rank test stratified by graded prognostic assessment (GPA) score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.||||0.933
73990772|NCT01657799|147527085|SUPERIORITY|||||||0.909|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.||||0.909
73990773|NCT01657799|147527085|SUPERIORITY||Hazard Ratio (HR)|0.985||||0.927|TWO_SIDED|95.0|0.716|1.355|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||||1.355|0.716|0.927
73990774|NCT01657799|147527085|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.906|TWO_SIDED|95.0|0.71|1.354|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||||1.354|0.710|0.906
73990775|NCT01657799|147527086|SUPERIORITY|||||||0.535|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.535
73990776|NCT01657799|147527086|SUPERIORITY|||||||0.898|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.898
73990777|NCT01657799|147527087|SUPERIORITY|||||||0.314|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.314
73990778|NCT01657799|147527087|SUPERIORITY|||||||0.536|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.536
73990779|NCT01657799|147527087|SUPERIORITY||Hazard Ratio (HR)|1.301||||0.313|TWO_SIDED|95.0|0.78|2.168|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||2.168|0.780|0.313
73990780|NCT01657799|147527087|SUPERIORITY||Hazard Ratio (HR)|1.181||||0.534|TWO_SIDED|95.0|0.698|1.999|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||1.999|0.698|0.534
74035332|NCT04507867|147623307|SUPERIORITY|Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||||0.078|||||||Fisher Exact|||||||0.078
74035333|NCT04507867|147623308|SUPERIORITY|||||||0.098|||||||t-test, 1 sided|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded||||0.098
73990781|NCT01657799|147527088|SUPERIORITY|||||||0.864|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.864
73990782|NCT01657799|147527088|SUPERIORITY|||||||0.301|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.301
73990783|NCT01657799|147527088|SUPERIORITY||Hazard Ratio (HR)|1.047||||0.86|TWO_SIDED|95.0|0.626|1.754|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||1.754|0.626|0.860
73990784|NCT01657799|147527088|SUPERIORITY||Hazard Ratio (HR)|1.295||||0.289|TWO_SIDED|95.0|0.803|2.086|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||2.086|0.803|0.289
73990785|NCT01496365|147527097|SUPERIORITY||Least squares mean|-0.05||||0.8916|TWO_SIDED|95.0|-0.81|0.7|||ANCOVA|||||0.70|-0.81|0.8916
73990786|NCT01496365|147527097|SUPERIORITY||Least squares mean|-0.22||||0.5569|TWO_SIDED|95.0|-0.95|0.51|||ANCOVA|||||0.51|-0.95|0.5569
73990787|NCT01496365|147527097|SUPERIORITY||Least squares mean|-0.53||||0.1544|TWO_SIDED|95.0|-1.25|0.2|||ANCOVA|||||0.20|-1.25|0.1544
73990788|NCT01496365|147527097|SUPERIORITY||Least squares mean|-0.94||||0.0137|TWO_SIDED|95.0|-1.69|-0.19|||ANCOVA|||||-0.19|-1.69|0.0137
73990789|NCT01496365|147527097|SUPERIORITY||Least squares mean|-0.88||||0.0171|TWO_SIDED|95.0|-1.61|0.16|||ANCOVA|||||0.16|-1.61|0.0171
73990790|NCT01496365|147527097|SUPERIORITY||Least square means|-1.01||||0.006|TWO_SIDED|95.0|-1.74|-0.29|||ANCOVA|||||-0.29|-1.74|0.0060
73990791|NCT01496365|147527097|SUPERIORITY||Least squares mean|-0.17||||0.7051|TWO_SIDED|95.0|-1.03|0.69|||ANCOVA|||||0.69|-1.03|0.7051
73990792|NCT01496365|147527097|SUPERIORITY||Least squares mean|-0.47||||0.2772|TWO_SIDED|95.0|-1.33|0.38|||ANCOVA|||||0.38|-1.33|0.2772
73990793|NCT01496365|147527097|SUPERIORITY||Least squares mean|-0.89||||0.0458|TWO_SIDED|95.0|-1.77|-0.02|||ANCOVA|||||-0.02|-1.77|0.0458
73990794|NCT01496365|147527097|SUPERIORITY||Least squares mean|-0.83||||0.0569|TWO_SIDED|95.0|-1.69|0.02|||ANCOVA|||||0.02|-1.69|0.0569
73990795|NCT01496365|147527097|SUPERIORITY||Least squares mean|-0.96||||0.0271|TWO_SIDED|95.0|-1.81|-0.11|||ANCOVA|||||-0.11|-1.81|0.0271
73990796|NCT01015677|147527128|SUPERIORITY_OR_OTHER||Differrence in the least squares means|-6.28||||0.488|TWO_SIDED|95.0|-24.2|11.64|||Longitudinal Data Analysis (LDA)|LDA model terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||11.64|-24.20|0.488
73990797|NCT01015677|147527128|SUPERIORITY_OR_OTHER||Difference in the least squares means|-17.45||||0.069|TWO_SIDED|95.0|-36.28|1.38|||Longitudinal Data Analysis|LDA model with terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||1.38|-36.28|0.069
74035334|NCT04507867|147623309|OTHER|||||||0.195|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group to analyze the presentation of post covid syndrome at the end of follow-up at day 40.||||0.195
74035335|NCT04507867|147623310|SUPERIORITY|||||||0.135|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||0.135
73990798|NCT01015677|147527131|SUPERIORITY_OR_OTHER||Differrence in the least squares means|-6.05||||0.529|TWO_SIDED|95.0|-25.06|12.96|||Longitudinal Data Analysis (LDA)|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||12.96|-25.06|0.529
73990799|NCT01015677|147527131|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.22||||0.264|TWO_SIDED|95.0|-31.03|8.59|||Longitudinal Data Analysis|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||8.59|-31.03|0.264
73990800|NCT01015677|147527132|SUPERIORITY_OR_OTHER||Difference in LS means|0.94||||0.827|TWO_SIDED|90.0|-6.19|8.07|||ANCOVA|Analysis of covariance (ANCOVA) with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.||||8.07|-6.19|0.827
73990801|NCT01015677|147527132|SUPERIORITY_OR_OTHER||Difference in the LS means|-14.52||||0.001|TWO_SIDED|90.0|-21.73|-7.32|||ANCOVA|ANCOVA with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.||||-7.32|-21.73|0.001
73990802|NCT01646385|147527139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.836||||0.084|TWO_SIDED|95.0|0.683|1.025|||Regression, Cox|||Cox proportional hazards model adjusted for age, baseline steroid, smoking history, previous cancer, and body mass index was used for analysis.||1.025|0.683|0.084
73990803|NCT01646385|147527140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.512||||0.035|TWO_SIDED|95.0|0.276|0.952|||Regression, Cox|||Cox proportional hazards model adjusted for age was used for analysis.||0.952|0.276|0.035
73990804|NCT01646385|147527141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.019||||0.855|TWO_SIDED|95.0|0.831|1.251|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, baseline DMARDs, methotrexate, disease activity score based on 28-joints count (DAS28), and smoking history was used for analysis.||1.251|0.831|0.855
73990805|NCT01646385|147527142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.001|TWO_SIDED|95.0|0.564|0.87|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, and baseline health assessment questionnaire (HAQ) score was used for analysis.||0.870|0.564|0.001
73990806|NCT01646385|147527143|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717||||0.024|TWO_SIDED|95.0|0.537|0.958|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, baseline HAQ score, Charlson index, smoking history, and body mass index was used for analysis.||0.958|0.537|0.024
73876182|NCT02163824|147294129|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.0307|TWO_SIDED||||||ANCOVA||Estimated value is the between group difference of mean ocular pain grade at Day 8.|||||0.0307
73990807|NCT01646385|147527146|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73990808|NCT01646385|147527147|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 1: analysis was performed with Analysis of Covariance (ANCOVA) using the General Linear Model (GLM) method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
73990809|NCT01646385|147527147|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
73990810|NCT01646385|147527147|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
73990811|NCT01646385|147527147|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 4: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
73990812|NCT01646385|147527147|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Change at Year 5: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||0.01
73990813|NCT01646385|147527150|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73876183|NCT02163824|147294130|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.2589|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference on mean ocular pain score at Day 15.|||||0.2589
73876184|NCT02163824|147294130|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.2132|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean ocular pain score at Day 15.|||||0.2132
73876185|NCT04862065|147294189|SUPERIORITY||Clinical Specificity (%)|99.96|||||TWO_SIDED|95.0|99.92|99.99|||Binomial Distribution|Specificity sample size is a minimum of 15,000 donors.||||99.99|99.92|
73876186|NCT04862065|147294190|OTHER|95% Confidence Interval provided|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
73876187|NCT04862065|147294191|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|94.87|100.0|||Sensitivity|||Sensitivity||100.00|94.87|
73990814|NCT01646385|147527151|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 1: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
73990815|NCT01646385|147527151|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
73990816|NCT01646385|147527151|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
73990817|NCT03539068|147527161|SUPERIORITY||||||<|1e-05|||||||Chi-squared|||||||<0.00001
73990818|NCT04599855|147527166|SUPERIORITY||least square (LS) means difference|-5.1|STANDARD_ERROR_OF_MEAN|1.42|<|0.001|TWO_SIDED|95.0|-7.91|-2.33|||Mixed model for repeated measures|||||-2.33|-7.91|<0.001
73990819|NCT04599855|147527166|SUPERIORITY||LS means difference|-6.8|STANDARD_ERROR_OF_MEAN|1.38|<|0.001|TWO_SIDED|95.0|-9.48|-4.07|||Mixed model for repeated measures|||||-4.07|-9.48|<0.001
73990820|NCT04599855|147527167|SUPERIORITY||LS means difference|-3.8|STANDARD_ERROR_OF_MEAN|1.29|=|0.004|TWO_SIDED|95.0|-6.29|-1.22|||Mixed model for repeated measures|||||-1.22|-6.29|=0.004
73990821|NCT04599855|147527167|SUPERIORITY||LS means difference|-3.4|STANDARD_ERROR_OF_MEAN|1.24|=|0.006|TWO_SIDED|95.0|-5.89|-1.0|||Mixed model for repeated measures|||||-1.00|-5.89|=0.006
73990822|NCT02165397|147527168|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.148|0.42||The treatment effect was tested with a stratified log rank test.|Log Rank||The hazard ratio and its 95% confidence interval were based on a Cox regression model stratified by the randomization stratification factors.|||0.420|0.148|< 0.0001
73990823|NCT02165397|147527169|SUPERIORITY||Rate Ratio|2.526|||<|0.0001|TWO_SIDED|95.0|1.753|3.639||Response rate was compared using Cochran-Mantel-Haenszel (CMH) chi-square test.|Cochran-Mantel-Haenszel|||||3.639|1.753|< 0.0001
73990824|NCT02165397|147527170|SUPERIORITY||Hazard Ratio (HR)|0.102|||<|0.0001|TWO_SIDED|95.0|0.049|0.212||P-value is from a stratified log-rank test.|Log Rank||Hazard ratio is estimated using a stratified Cox regression model.|||0.212|0.049|< 0.0001
73990825|NCT02165397|147527171|SUPERIORITY||Rate Ratio|1.813|||<|0.0001|TWO_SIDED|95.0|1.357|2.421|||Chi-squared|||||2.421|1.357|< 0.0001
73990826|NCT02165397|147527172|SUPERIORITY||Rate Ratio|1.238||||0.1059|TWO_SIDED|95.0|0.955|1.603||CMH chi squared test|Cochran-Mantel-Haenszel|||||1.603|0.955|0.1059
73990827|NCT02165397|147527173|SUPERIORITY||Hazard Ratio (HR)|0.808||||0.643|TWO_SIDED|95.0|0.328|1.99||P-value is from unstratified log rank test.|Log Rank||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|Data cutoff 18 December 2019||1.99|0.328|0.643
73990828|NCT00424554|147527206|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
73990829|NCT00236184|147527217|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||||||<0.001
74035336|NCT04507867|147623311|SUPERIORITY|||||||0.266|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||0.266
73990830|NCT02312206|147527218|SUPERIORITY||Hazard Ratio (HR)|0.826||||0.3028|TWO_SIDED|95.0|0.5735|1.1889|||Log Rank|||||1.1889|0.5735|0.3028
73990831|NCT00364377|147527219|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||Paired comparisons (within groups) to examine differences between the baseline study and after 8-weeks of treatment were made using Student's two-tailed t-test for paired samples. Between-group comparisons were made using Student's two-tailed t-test for unpaired samples. Given the previously observed variation in fasting glucose||||>0.05
73990832|NCT00736125|147527236|EQUIVALENCE|nonparametric data were analyzed using Mann Whitney U Tests|||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73990833|NCT00736125|147527237|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
73990834|NCT02250534|147527248|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
73990835|NCT02250534|147527248|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.03 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 6.07 CPD between the 0.8 mg and 0.03 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-5.57|-9.51|<0.0001
73990836|NCT01182181|147527251|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.6|||||TWO_SIDED|90.0|92.34|98.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.95|92.34|
73990837|NCT01182181|147527252|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.3|||||TWO_SIDED|90.0|93.14|99.57|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.57|93.14|
73876188|NCT03170661|147294194|SUPERIORITY|||||||0.94|||||||GEEGLM|Effects of GEEGLM covariates: surgeon, p = 0.24; surgery length, p= 0.73 and body mass index, p= 0.22).||||||0.94
73990838|NCT03845075|147527256|SUPERIORITY||LS Mean Difference|3.6||||0.4671|TWO_SIDED|95.0|-6.58|13.78||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||13.78|-6.58|0.4671
74035337|NCT04507867|147623312|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.002|||||||Fisher Exact|||||||0.002
73990839|NCT03845075|147527256|SUPERIORITY||LS Mean Difference|10.11||||0.1808|TWO_SIDED|95.0|-5.14|25.36||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||25.36|-5.14|0.1808
73990840|NCT03845075|147527256|SUPERIORITY||LS Mean Difference|4.63||||0.4171|TWO_SIDED|95.0|-7.08|16.33||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||16.33|-7.08|0.4171
73990841|NCT03845075|147527256|SUPERIORITY||LS Mean Difference|5.33||||0.3116|TWO_SIDED|95.0|-5.43|16.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||16.10|-5.43|0.3116
73990842|NCT03845075|147527256|SUPERIORITY||LS Mean Difference|5.8||||0.2353|TWO_SIDED|95.0|-4.12|15.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||15.72|-4.12|0.2353
73990843|NCT03845075|147527256|SUPERIORITY||LS Mean Difference|5.86||||0.3037|TWO_SIDED|95.0|-5.76|17.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||17.48|-5.76|0.3037
73990844|NCT03845075|147527257|SUPERIORITY||LS Mean Difference|-1.31||||0.6543|TWO_SIDED|95.0|-7.33|4.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||4.72|-7.33|0.6543
73990845|NCT03845075|147527257|SUPERIORITY||LS Mean Difference|0.94||||0.7941|TWO_SIDED|95.0|-6.5|8.38||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||8.38|-6.50|0.7941
73990846|NCT03845075|147527257|SUPERIORITY||LS Mean Difference|-2.0||||0.5937|TWO_SIDED|95.0|-9.72|5.73||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||5.73|-9.72|0.5937
73990847|NCT03845075|147527257|SUPERIORITY||LS Mean Difference|2.56||||0.5423|TWO_SIDED|95.0|-6.11|11.23||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||11.23|-6.11|0.5423
73990848|NCT03845075|147527257|SUPERIORITY||LS Mean Difference|1.2||||0.7226|TWO_SIDED|95.0|-5.77|8.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||8.16|-5.77|0.7226
73990849|NCT03845075|147527257|SUPERIORITY||LS Mean Difference|1.15||||0.7912|TWO_SIDED|95.0|-7.85|10.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||10.16|-7.85|0.7912
73990850|NCT03845075|147527258|SUPERIORITY||LS Mean Difference|-1.35||||0.7023|TWO_SIDED|95.0|-8.67|5.97||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||5.97|-8.67|0.7023
73990851|NCT03845075|147527258|SUPERIORITY||LS Mean Difference|-0.48||||0.9012|TWO_SIDED|95.0|-8.58|7.61||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||7.61|-8.58|0.9012
73990852|NCT03845075|147527258|SUPERIORITY||LS Mean Difference|2.14||||0.6138|TWO_SIDED|95.0|-6.63|10.92||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||10.92|-6.63|0.6138
73990853|NCT03845075|147527258|SUPERIORITY||LS Mean Difference|1.23||||0.7889|TWO_SIDED|95.0|-8.26|10.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||10.72|-8.26|0.7889
74035338|NCT04507867|147623313|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.003|||||||Fisher Exact|||||||0.003
74035339|NCT04507867|147623314|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.004|||||||Fisher Exact|||||||0.004
74035340|NCT04507867|147623315|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.011|||||||Fisher Exact|||||||0.011
74035341|NCT04507867|147623316|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.031|||||||Fisher Exact|||||||0.031
74035342|NCT04507867|147623317|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.04|||||||Fisher Exact|||||||0.040
74035343|NCT04507867|147623318|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.047|||||||Fisher Exact|||||||0.047
73990854|NCT03845075|147527258|SUPERIORITY||LS Mean Difference|0.3||||0.9536|TWO_SIDED|95.0|-10.34|10.94||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||10.94|-10.34|0.9536
73990855|NCT03845075|147527258|SUPERIORITY||LS Mean Difference|2.7||||0.5551|TWO_SIDED|95.0|-6.72|12.12||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||12.12|-6.72|0.5551
73990856|NCT03845075|147527262|SUPERIORITY||LS Mean Difference|-2.52||||0.7782|TWO_SIDED|95.0|-21.23|16.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24||16.20|-21.23|0.7782
73990857|NCT03845075|147527262|SUPERIORITY||LS Mean Difference|-7.26||||0.313|TWO_SIDED|95.0|-22.09|7.56||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48||7.56|-22.09|0.3130
73990858|NCT03845075|147527262|SUPERIORITY||LS Mean Difference|-5.73||||0.4033|TWO_SIDED|95.0|-19.92|8.47||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48||8.47|-19.92|0.4033
73990859|NCT03845075|147527263|SUPERIORITY||LS Mean Difference|-7.5||||0.0325|TWO_SIDED|95.0|-14.29|-0.71||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24||-0.71|-14.29|0.0325
73990860|NCT03845075|147527263|SUPERIORITY||LS Mean Difference|-0.32||||0.9394|TWO_SIDED|95.0|-9.04|8.4||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48||8.40|-9.04|0.9394
73990861|NCT03845075|147527263|SUPERIORITY||LS Mean Difference|6.91||||0.0135|TWO_SIDED|95.0|1.65|12.18||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 28||12.18|1.65|0.0135
73990862|NCT03845075|147527264|SUPERIORITY||LS Mean Difference|-4.17||||0.1048|TWO_SIDED|95.0|-9.31|0.98||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed.||0.98|-9.31|0.1048
73990863|NCT03845075|147527264|SUPERIORITY||LS Mean Difference|-0.99||||0.7189|TWO_SIDED|95.0|-6.75|4.77||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT observed.||4.77|-6.75|0.7189
73990864|NCT03845075|147527264|SUPERIORITY||LS Mean Difference|3.09||||0.1053|TWO_SIDED|95.0|-0.73|6.91||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT observed.||6.91|-0.73|0.1053
73990865|NCT03845075|147527265|SUPERIORITY||LS Mean Difference|-3.12||||0.0033|TWO_SIDED|95.0|-5.02|-1.21||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed||-1.21|-5.02|0.0033
74035344|NCT02403830|147623319|SUPERIORITY||Mean Difference (Final Values)|-32.0||||0.261|TWO_SIDED|95.0|-90.0|25.0|||Mixed Models Analysis|||||25|-90|0.261
73990866|NCT03845075|147527265|SUPERIORITY||LS Mean Difference|0.58||||0.6663|TWO_SIDED|95.0|-2.24|3.41||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||3.41|-2.24|0.6663
73990867|NCT03845075|147527265|SUPERIORITY||LS Mean Difference|3.59||||0.0058|TWO_SIDED|95.0|1.21|5.98||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||5.98|1.21|0.0058
74039698|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.42|||<|0.0001|TWO_SIDED|95.0|1.62|3.62|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.62|1.62|<.0001
74039699|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6765|TWO_SIDED|95.0|0.72|1.65|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.65|0.72|0.6765
73876189|NCT01272232|147294200|SUPERIORITY_OR_OTHER||Treatment contrast|-3.97|||<|0.0001||95.0|-4.84|-3.11||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-3.11|-4.84|<0.0001
73876190|NCT01272232|147294200|SUPERIORITY_OR_OTHER||Treatment contrast|-2.62|||<|0.0001||95.0|-3.63|-1.62||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.62|-3.63|<0.0001
73876191|NCT01272232|147294200|SUPERIORITY_OR_OTHER||Treatment contrast|-1.35||||0.0024||95.0|-2.23|-0.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.48|-2.23|0.0024
73876192|NCT01272232|147294201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.81|||<|0.0001||95.0|4.34|10.68||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||10.68|4.34|<0.0001
73990868|NCT03845075|147527266|SUPERIORITY||LS Mean Difference|-3.02||||0.0713|TWO_SIDED|95.0|-6.34|0.3||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed||0.30|-6.34|0.0713
73990869|NCT03845075|147527266|SUPERIORITY||LS Mean Difference|-2.48||||0.1457|TWO_SIDED|95.0|-5.92|0.96||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||0.96|-5.92|0.1457
73990870|NCT03845075|147527266|SUPERIORITY||LS Mean Difference|0.85||||0.1837|TWO_SIDED|95.0|-0.45|2.15||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||2.15|-0.45|0.1837
73990871|NCT03845075|147527267|SUPERIORITY||LS Mean Difference|-0.05||||0.7926|TWO_SIDED|95.0|-0.42|0.33||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT LOCF||0.33|-0.42|0.7926
73990872|NCT03845075|147527267|SUPERIORITY||LS Mean Difference|-0.27||||0.2124|TWO_SIDED|95.0|-0.72|0.17||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||0.17|-0.72|0.2124
73990873|NCT03845075|147527267|SUPERIORITY||LS Mean Difference|-0.14||||0.6084|TWO_SIDED|95.0|-0.72|0.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||0.43|-0.72|0.6084
73990874|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|16.0||||0.0905|TWO_SIDED|95.0|-2.85|34.85||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to week 24; mITT observed. (Like to eat something fatty)||34.85|-2.85|0.0905
73990875|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|6.65||||0.6285|TWO_SIDED|95.0|-22.05|35.36||P-value from ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Like some meat/fish)||35.36|-22.05|0.6285
73990876|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|-6.81||||0.5884|TWO_SIDED|95.0|-33.05|19.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Eat something salty).||19.43|-33.05|0.5884
73990877|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|2.98||||0.8533|TWO_SIDED|95.0|-30.73|36.68||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Eat something sweet).||36.68|-30.73|0.8533
74039700|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0022|TWO_SIDED|95.0|1.23|2.54|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.54|1.23|0.0022
73876193|NCT01272232|147294201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69|||<|0.0001||95.0|2.24|6.09||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||6.09|2.24|<0.0001
73876194|NCT01272232|147294201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0008||95.0|1.29|2.64||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.64|1.29|0.0008
73990878|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|-17.33||||0.1529|TWO_SIDED|95.0|-41.87|7.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Like to eat something fatty).||7.20|-41.87|0.1529
73990879|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|-11.75||||0.3399|TWO_SIDED|95.0|-37.15|13.65||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Like some meat/fish).||13.65|-37.15|0.3399
73990880|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|-23.95||||0.0673|TWO_SIDED|95.0|-49.84|1.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Eat something salty).||1.93|-49.84|0.0673
73990881|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|-22.6||||0.1657|TWO_SIDED|95.0|-55.65|10.46||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Eat something sweet).||10.46|-55.65|0.1657
73990882|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|-30.18||||0.0108|TWO_SIDED|95.0|-52.31|-8.06||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Like to eat something fatty).||-8.06|-52.31|0.0108
73990883|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|-14.79||||0.171|TWO_SIDED|95.0|-36.71|7.13||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Like some meat/fish).||7.13|-36.71|0.1710
73990884|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|-19.86||||0.0083|TWO_SIDED|95.0|-33.8|-5.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Eat something salty).||-5.93|-33.80|0.0083
73990885|NCT03845075|147527268|SUPERIORITY||LS Mean Difference|-22.98||||0.0631|TWO_SIDED|95.0|-47.39|1.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Eat something sweet).||1.43|-47.39|0.0631
73990886|NCT03845075|147527269|SUPERIORITY||LS Mean Difference|-2.56||||0.8082|TWO_SIDED|95.0|-24.65|19.53||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed.||19.53|-24.65|0.8082
73990887|NCT03845075|147527269|SUPERIORITY||LS Mean Difference|-1.42||||0.9034|TWO_SIDED|95.0|-25.94|23.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF.||23.10|-25.94|0.9034
73990888|NCT03845075|147527269|SUPERIORITY||LS Mean Difference|-7.0||||0.4658|TWO_SIDED|95.0|-26.93|12.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF.||12.93|-26.93|0.4658
73990889|NCT03845075|147527270|SUPERIORITY||LS Mean Difference|-5.68||||0.0537|TWO_SIDED|95.0|-11.46|0.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT LOCF.||0.10|-11.46|0.0537
74039701|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.56|3.15|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.15|1.56|<.0001
73990890|NCT03845075|147527270|SUPERIORITY||LS Mean Difference|-2.69||||0.3772|TWO_SIDED|95.0|-8.98|3.61||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF.||3.61|-8.98|0.3772
73990891|NCT03845075|147527270|SUPERIORITY||LS Mean Difference|3.03||||0.1171|TWO_SIDED|95.0|-0.85|6.91||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF.||6.91|-0.85|0.1171
73990892|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|-0.05||||0.8623|TWO_SIDED|95.0|-0.59|0.5||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in total cholesterol)||0.50|-0.59|0.8623
73990893|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|0.03||||0.8327|TWO_SIDED|95.0|-0.25|0.3||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in HDL cholesterol)||0.30|-0.25|0.8327
73990894|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|-0.06||||0.808|TWO_SIDED|95.0|-0.53|0.42||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in LDL cholesterol)||0.42|-0.53|0.8080
73990895|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|0.22||||0.5791|TWO_SIDED|95.0|-0.62|1.07|||ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in triglycerides)||1.07|-0.62|0.5791
73990896|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|0.03||||0.9337|TWO_SIDED|95.0|-0.71|0.77||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in cholesterol)||0.77|-0.71|0.9337
73990897|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|0.01||||0.9305|TWO_SIDED|95.0|-0.21|0.23||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in HDL cholesterol)||0.23|-0.21|0.9305
73990898|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|0.09||||0.691|TWO_SIDED|95.0|-0.4|0.59||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in LDL cholesterol)||0.59|-0.40|0.6910
73990899|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|0.35||||0.2688|TWO_SIDED|95.0|-0.3|1.01||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in triglycerides)||1.01|-0.30|0.2688
74035345|NCT01954251|147623325|NON_INFERIORITY_OR_EQUIVALENCE|Comparison at one month after the last dose of HZ/su was performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non-inferior compared to the Control group in terms of immunogenicity if the UL of the 2-sided 95% CI of the ratio of GMs between the Control and the Co-Ad group (Control over GSK1437173A + GSK2321138A) was below 1.5.|Adjusted Geometric mean concentration ra|1.08|||||TWO_SIDED|95.0|0.97|1.2||||||Adjusted ratios of Control group over GSK1437173A + GSK2321138A group in anti-gE antibody ELISA concentrations GMCs at one month after last vaccine dose. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed concentrations of anti-gE. The fixed-effect model included the minimisation variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate.||1.20|0.97|
74039702|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.98||||0.027|TWO_SIDED|95.0|1.08|3.63|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.63|1.08|0.0270
73990900|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|0.06||||0.8262|TWO_SIDED|95.0|-0.54|0.67||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in cholesterol)||0.67|-0.54|0.8262
73990901|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|-0.02||||0.8293|TWO_SIDED|95.0|-0.2|0.17||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in HDL cholesterol)||0.17|-0.20|0.8293
74039703|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.43||||0.003|TWO_SIDED|95.0|1.35|4.38|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.38|1.35|0.0030
73990902|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|0.11||||0.5486|TWO_SIDED|95.0|-0.27|0.49||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in LDL cholesterol)||0.49|-0.27|0.5486
73990903|NCT03845075|147527271|SUPERIORITY||LS Mean Difference|0.24||||0.3226|TWO_SIDED|95.0|-0.26|0.75||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in triglycerides)||0.75|-0.26|0.3226
73990904|NCT03845075|147527272|SUPERIORITY||LS Mean Difference|0.59||||0.842|TWO_SIDED|95.0|-5.55|6.73||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Physical component score)||6.73|-5.55|0.8420
73990905|NCT03845075|147527272|SUPERIORITY||LS Mean Difference|-1.74||||0.6693|TWO_SIDED|95.0|-10.15|6.67||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Mental component score)||6.67|-10.15|0.6693
73990906|NCT03845075|147527272|SUPERIORITY||LS Mean Difference|-1.83||||0.5444|TWO_SIDED|95.0|-8.12|4.46||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; mITT LOCF. (Physical component score)||4.46|-8.12|0.5444
73990907|NCT03845075|147527272|SUPERIORITY||LS Mean Difference|-1.85||||0.5595|TWO_SIDED|95.0|-8.47|4.76||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; mITT LOCF. (Mental component score)||4.76|-8.47|0.5595
73990908|NCT03845075|147527272|SUPERIORITY||LS Mean Difference|-2.07||||0.4331|TWO_SIDED|95.0|-7.54|3.41||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Physical component score)||3.41|-7.54|0.4331
73990909|NCT03845075|147527272|SUPERIORITY||LS Mean Difference|-1.44||||0.6427|TWO_SIDED|95.0|-7.9|5.03||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Mental component score)||5.03|-7.90|0.6427
73990910|NCT03845075|147527274|SUPERIORITY||LS Mean Difference|5.86||||0.3037|TWO_SIDED|95.0|-5.76|17.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in systolic blood pressure)||17.48|-5.76|0.3037
74035346|NCT01954251|147623326|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.04|||||TWO_SIDED|95.0|0.88|1.22||||||For the Flu A/California/7/2009 H1N1 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.22|0.88|
74039704|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|0.74||||0.377|TWO_SIDED|95.0|0.38|1.44|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.44|0.38|0.3770
73990911|NCT03845075|147527274|SUPERIORITY||LS Mean Difference|1.15||||0.7912|TWO_SIDED|95.0|-7.85|10.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in diastolic blood pressure)||10.16|-7.85|0.7912
73990912|NCT03845075|147527274|SUPERIORITY||LS Mean Difference|10.29||||0.1773|TWO_SIDED|95.0|-5.25|25.83||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in systolic blood pressure)||25.83|-5.25|0.1773
73990913|NCT03845075|147527274|SUPERIORITY||LS Mean Difference|1.32||||0.798|TWO_SIDED|95.0|-9.55|12.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in diastolic blood pressure)||12.20|-9.55|0.7980
73990914|NCT03845075|147527274|SUPERIORITY||LS Mean Difference|7.77||||0.158|TWO_SIDED|95.0|-3.4|18.94||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in systolic blood pressure)||18.94|-3.40|0.1580
73990915|NCT03845075|147527274|SUPERIORITY||LS Mean Difference|1.64||||0.7021|TWO_SIDED|95.0|-7.36|10.64||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in diastolic blood pressure)||10.64|-7.36|0.7021
73876195|NCT01272232|147294202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.1|||<|0.0001||95.0|3.48|14.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||14.48|3.48|<0.0001
73990916|NCT03845075|147527275|SUPERIORITY||LS Mean Difference|1.5||||0.8728|TWO_SIDED|95.0|-18.17|21.18||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Change in systolic blood pressure mean)||21.18|-18.17|0.8728
73990917|NCT03845075|147527275|SUPERIORITY||LS Mean Difference|2.46||||0.5714|TWO_SIDED|95.0|-6.61|11.54||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Change in diastolic blood pressure mean)||11.54|-6.61|0.5714
73990918|NCT03845075|147527275|SUPERIORITY||LS Mean Difference|-10.15||||0.2322|TWO_SIDED|95.0|-27.51|7.22||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 12; mITT LOCF. (Change in systolic blood pressure mean)||7.22|-27.51|0.2322
73990919|NCT03845075|147527275|SUPERIORITY||LS Mean Difference|-3.46||||0.4321|TWO_SIDED|95.0|-12.61|5.68||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 12; mITT LOCF. (Change in diastolic blood pressure mean)||5.68|-12.61|0.4321
73990920|NCT03845075|147527278|SUPERIORITY||LS Mean Difference|2.7||||0.5551|TWO_SIDED|95.0|-6.72|12.12||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in heart rate)||12.12|-6.72|0.5551
73990921|NCT03845075|147527278|SUPERIORITY||LS Mean Difference|-2.13||||0.7256|TWO_SIDED|95.0|-14.88|10.63||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in heart rate)||10.63|-14.88|0.7256
73990922|NCT03845075|147527278|SUPERIORITY||LS Mean Difference|-3.29||||0.4822|TWO_SIDED|95.0|-13.05|6.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in heart rate)||6.48|-13.05|0.4822
73990923|NCT03856047|147527279|SUPERIORITY||Treatment difference (%-points)|-2.99|STANDARD_ERROR_OF_MEAN|0.81||0.0002|TWO_SIDED|95.0|-4.58|-1.4|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance (ANCOVA) model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-1.40|-4.58|0.0002
73990924|NCT03856047|147527279|SUPERIORITY||Treatment difference (%-points)|-3.78|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|-5.38|-2.17|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-2.17|-5.38|<.0001
73990925|NCT03856047|147527279|SUPERIORITY||Treatment difference (%-points)|-6.07|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|-7.77|-4.36|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-4.36|-7.77|<.0001
73990926|NCT03856047|147527279|SUPERIORITY||Treatment difference (%-points)|-6.68|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-8.28|-5.09|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-5.09|-8.28|<.0001
73990927|NCT03856047|147527279|SUPERIORITY||Treatment difference (%-points)|-7.79|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-9.42|-6.16|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-6.16|-9.42|<.0001
73990928|NCT03856047|147527279|SUPERIORITY||Treatment difference (%-points)|-5.98|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-7.61|-4.35|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-4.35|-7.61|<.0001
74039705|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0009|TWO_SIDED|95.0|1.49|4.79|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.79|1.49|0.0009
73876196|NCT01272232|147294202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84||||0.0008||95.0|1.75|8.41||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||8.41|1.75|0.0008
73990929|NCT03856047|147527279|SUPERIORITY||Treatment difference (%-points)|2.99|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|1.38|4.6|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||4.60|1.38|0.0003
73990930|NCT03856047|147527279|SUPERIORITY||Treatment difference (%-points)|2.2|STANDARD_ERROR_OF_MEAN|0.83||0.0082|TWO_SIDED|95.0|0.57|3.84|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||3.84|0.57|0.0082
73990931|NCT03856047|147527279|SUPERIORITY||Treatment difference (%-points)|-0.09|STANDARD_ERROR_OF_MEAN|0.88||0.9209|TWO_SIDED|95.0|-1.82|1.64|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||1.64|-1.82|0.9209
73990932|NCT03856047|147527279|SUPERIORITY||Treatment difference (%-points)|-0.7|STANDARD_ERROR_OF_MEAN|0.83||0.396|TWO_SIDED|95.0|-2.33|0.92|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||0.92|-2.33|0.3960
73990933|NCT03856047|147527279|SUPERIORITY||Treatment difference (%-points)|-1.81|STANDARD_ERROR_OF_MEAN|0.84||0.0316|TWO_SIDED|95.0|-3.46|-0.16|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-0.16|-3.46|0.0316
73990934|NCT00905359|147527313|NON_INFERIORITY_OR_EQUIVALENCE|t-test analysis performed using Multiple imputation and one-sided p-value testing non-inferiority of the percentage change from baseline at 10%. One-sided p-value is significant if \<0.025 or the upper limit of the CI is less than 10%.||||||0.172|||||||t-test, 1 sided|||||||0.172
73990935|NCT02138253|147527328|SUPERIORITY|For the primary efficacy analysis based on the Month 24 biopsy, subjects with a missing Month 24 biopsy had their Ishak fibrosis score imputed. Imputation of missing Ishak fibrosis scores was conducted using multiple imputation (MI). Results were imputed based on age, gender, baseline Ishak fibrosis score, and the Month 12 Ishak fibrosis score.|Risk Difference (RD)|2.9||||0.73|TWO_SIDED|95.0|-20.5|26.4||Stratified by baseline Ishak Fibrosis Score strata (F2, F3+F4+F5, and F6).|Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||26.4|-20.5|0.73
73876197|NCT01272232|147294202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.0099||95.0|1.16|2.95||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.95|1.16|0.0099
73990936|NCT02138253|147527329|SUPERIORITY||Risk Difference (RD)|4.4||||0.658|TWO_SIDED|95.0|-20.0|28.9|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||28.9|-20.0|0.658
73990937|NCT02138253|147527330|SUPERIORITY||Risk Difference (RD)|-7.9||||0.421|TWO_SIDED|95.0|-28.8|13.1|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||13.1|-28.8|0.421
73990938|NCT02654132|147527340|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0043|TWO_SIDED|95.0|0.32|0.82|||Log Rank|||||0.82|0.32|0.0043
73990939|NCT02654132|147527341|SUPERIORITY||Odds Ratio (OR)|4.62||||0.0002|TWO_SIDED|95.0|2.05|10.43|||Cochran-Mantel-Haenszel|||||10.43|2.05|0.0002
73990940|NCT02654132|147527342|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0217|TWO_SIDED|95.0|0.37|0.93|||Log Rank|||||0.93|0.37|0.0217
73990941|NCT00243022|147527379|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||||||0.9
73990942|NCT00243022|147527380|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||||||0.12
73990943|NCT00243022|147527381|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||||||0.8
73876198|NCT01272232|147294203|SUPERIORITY_OR_OTHER||Treatment contrast|-0.93|||<|0.0001||95.0|-1.08|-0.78||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.78|-1.08|<0.0001
73990944|NCT04706793|147527446|OTHER||Risk Difference (RD)|17.86|||||TWO_SIDED|95.0|-3.1|38.82||||||||38.82|-3.10|
73990945|NCT04706793|147527447|OTHER||Risk Difference (RD)|28.57|||||TWO_SIDED|95.0|6.28|50.86||||||||50.86|6.28|
73990946|NCT04706793|147527448|OTHER||Risk Difference (RD)|32.14|||||TWO_SIDED|95.0|9.58|54.71||||||||54.71|9.58|
73990947|NCT04706793|147527449|OTHER||Risk Difference (RD)|21.43|||||TWO_SIDED|95.0|-0.07|42.92||||||||42.92|-0.07|
73990948|NCT04706793|147527450|OTHER||Risk Difference (RD)|17.86|||||TWO_SIDED|95.0|-3.1|38.82||||||||38.82|-3.10|
73990949|NCT04706793|147527451|OTHER||Risk Difference (RD)|7.14|||||TWO_SIDED|95.0|-2.4|16.68||||||||16.68|-2.40|
74035347|NCT01954251|147623326|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.03|||||TWO_SIDED|95.0|0.91|1.17||||||For the Flu A/Texas/50/2012 H3N2 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.17|0.91|
73876199|NCT01272232|147294203|SUPERIORITY_OR_OTHER||Treatment contrast|-0.74|||<|0.0001||95.0|-0.91|-0.57||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.57|-0.91|<0.0001
73876200|NCT01272232|147294203|SUPERIORITY_OR_OTHER||Treatment contrast|-0.19||||0.0125||95.0|-0.34|-0.04||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.04|-0.34|0.0125
73990950|NCT03713320|147527462|SUPERIORITY|||||||0.9539|||||||Cochran-Mantel-Haenszel|||Comparison of the treatment groups is based on a Cochran-Mantel-Haenzel test controlling for the number of tumors at screening (at least one tumor at screening versus no tumors at screening) and number of prognostic factors (0-1 versus 2 prognostic factors). Prognostic factors include age at diagnosis \> 60 years and lactate dehydrogenase level \> upper limit of normal at diagnosis. Number of subjects achieving ORR4 and exact binomial (Clopper-Pearson) confidence intervals are presented.||||.9539
73990951|NCT03713320|147527463|SUPERIORITY|||||||0.011|||||||Regression, Cox|||Hazard ratio (cobomarsen/vorinostat) and p-value comparing the treatment groups is based on a Cox proportional hazards model. A hazard ratio \< 1 favors cobomarsen over vorinostat.||||0.011
73990952|NCT02601209|147527539|OTHER||Maximum Tolerated Dose (mg)|30.0|||||TWO_SIDED|||||||||||||
73990953|NCT02601209|147527540|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.1419|ONE_SIDED|85.0||1.7|||Log Rank|1-sided statistical test and p-value||||1.70||0.1419
73990954|NCT02804399|147527555|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|14.74|||||TWO_SIDED|90.0|12.78|17.01||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||17.01|12.78|
73990955|NCT02804399|147527556|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|23.88|||||TWO_SIDED|90.0|21.58|26.43||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||26.43|21.58|
73990956|NCT02804399|147527557|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|13.96|||||TWO_SIDED|90.0|12.09|16.12||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||16.12|12.09|
73990957|NCT03636373|147527576|NON_INFERIORITY|On a 10 point Likert Pain Scale, non-inferiority margin for the difference is 1.04. Using a Student t-test, there was 80% power for the difference in pain levels to exceed -1.04.||||||1|||||||t-test, 1 sided|||Mean Outcome measure Etanercept arm { ( 8 + 0 + 7)/3 = 5} Triamcinolone Arm { (3+0) /2 = 1.5 }||||1.00
73990958|NCT03636373|147527577|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.00
73990959|NCT03636373|147527578|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73990960|NCT03636373|147527579|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73990961|NCT03636373|147527580|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73990962|NCT03636373|147527581|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
73990963|NCT01182207|147527596|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.74|||||TWO_SIDED|90.0|86.82|107.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.79|86.82|
73990964|NCT01182207|147527597|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.16|||||TWO_SIDED|90.0|101.1|105.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.27|101.10|
73990965|NCT01182207|147527598|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.72|||||TWO_SIDED|90.0|100.67|104.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.80|100.67|
73990966|NCT01182207|147527599|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||TWO_SIDED|90.0|89.45|106.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.50|89.45|
73990967|NCT01182207|147527600|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.88|||||TWO_SIDED|90.0|95.62|102.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.25|95.62|
73990968|NCT01182207|147527601|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.2|||||TWO_SIDED|90.0|95.36|101.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.12|95.36|
73990969|NCT01427738|147527602|SUPERIORITY_OR_OTHER||Difference in proportion with clinical e|0.044|||||TWO_SIDED|95.1|-0.077|0.166||||||Repeated confidence intervals (RCIs) were used to control type I error.A interim analysis was conducted by a 99.7% CI. The final analyses use a 95.1% CI, based on the Lan-DeMets error-spending function corresponding to the O'Brien-Fleming boundary.76% of 100 participant in arm GV had cure or improvement of OC after 14 days of treatment, and 71.6% of 102 in arm nystatin had cure or improvement of OC. Difference in clinical efficacy rates between GV and nystatin 95.1% CI is 0.044 (-0.077, 0.166).||0.166|-0.077|
73990970|NCT02037256|147527637|OTHER||percentage|0.24|||||TWO_SIDED|95.0|0.07|0.5||||||Median time to engraftment||0.50|0.07|
73990971|NCT02166476|147527657|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Noninferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for the treatment difference for overall success at EOIVT was \>-15%.|Treatment difference|4.5|||||TWO_SIDED|95.0|0.7|9.1|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population||9.1|0.7|
73990972|NCT02166476|147527658|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the m-MITT Population.|Treatment difference|9.0|||||TWO_SIDED|95.0|-0.9|18.7|||||Treatment difference is the estimate of the difference in the Eradication rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population||18.7|-0.9|
73990973|NCT02166476|147527659|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the ME Population.|Treatment Difference|5.9|||||TWO_SIDED|95.0|-4.2|16.0|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the ME population||16.0|-4.2|
73990974|NCT01076244|147527696|SUPERIORITY_OR_OTHER||change from baseline|13.43|STANDARD_DEVIATION|16.55|<|0.0001|TWO_SIDED|95.0|8.42|18.43|||t-test, 2 sided|||||18.43|8.42|<0.0001
73990975|NCT01076244|147527698|SUPERIORITY_OR_OTHER||change from baseline|2.17|STANDARD_DEVIATION|3.29|<|0.0001|TWO_SIDED|95.0|1.17|3.16|||t-test, 2 sided|||||3.16|1.17|<0.0001
73990976|NCT02053610|147527702|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.41|0.58|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.58|0.41|<0.0001
73990977|NCT02053610|147527704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.33|0.54|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|Stratified by Binet stage at Baseline.|||0.54|0.33|<0.0001
73990978|NCT02053610|147527706|SUPERIORITY_OR_OTHER||Difference in Response Rates|13.22||||0.0001|TWO_SIDED|95.0|6.3|20.1|||Chi-squared|||Includes participants with EOTR: CR, CRi, PR or nPR.||20.1|6.3|0.0001
73990979|NCT02053610|147527707|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.92||||0.0002|TWO_SIDED|95.0|6.1|19.8|||Chi-squared|||Includes participants with best overall response: CR, CRi, PR or nPR.||19.8|6.1|0.0002
73990980|NCT02053610|147527708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.43|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.61|0.43|<0.0001
73990981|NCT02053610|147527709|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.76||||0.0245|TWO_SIDED|95.0|0.6|0.97|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.97|0.60|0.0245
73990982|NCT02053610|147527710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.41|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.61|0.41|<0.0001
73990983|NCT02053610|147527712|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.73|0.46|<0.0001
73990984|NCT02768597|147527733|SUPERIORITY|||||||0.552|||||||ANOVA|||||||.552
74035348|NCT01954251|147623326|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2||||||For the Flu B/Brisbane/60/2008 Victoria strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.20|0.95|
74035349|NCT01954251|147623326|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|0.98|||||TWO_SIDED|95.0|0.88|1.09||||||For the Flu B/Massachusetts/2/2012 Yamagata strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.09|0.88|
74035350|NCT00779324|147623340|OTHER||Difference in percents|-0.4||||0.9554|TWO_SIDED|95.0|-14.7|13.9|||Chi-squared|||||13.9|-14.7|0.9554
73876201|NCT01272232|147294204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.79|||<|0.0001||95.0|5.74|13.4||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||13.4|5.74|<0.0001
73990985|NCT02768597|147527734|SUPERIORITY|||||||0.558|||||||ANOVA|||||||.558
73990986|NCT02768597|147527735|SUPERIORITY|||||||0.274|||||||Kruskal-Wallis|||||||.274
73990987|NCT02768597|147527736|SUPERIORITY|||||||0.539|||||||Kruskal-Wallis|||||||.539
73990988|NCT02768597|147527737|SUPERIORITY|||||||0.478|||||||Kruskal-Wallis|||||||.478
73990989|NCT02768597|147527738|SUPERIORITY|||||||0.527|||||||ANOVA|||||||.527
73990990|NCT02768597|147527739|SUPERIORITY|||||||0.823|||||||ANOVA|||||||.823
73990991|NCT02768597|147527740|SUPERIORITY|||||||0.231|||||||ANOVA|||||||.231
73990992|NCT02768597|147527741|SUPERIORITY|||||||0.595|||||||Kruskal-Wallis|||||||.595
73990993|NCT02768597|147527742|SUPERIORITY|||||||0.789|||||||Kruskal-Wallis|||||||.789
73990994|NCT02232399|147527743|OTHER|||||||0.45||||||To test whether there were any significant differences between the two treatment groups over time (group vs time interaction), a repeated measurement mixed-model approach was used. This assumed an unstructured covariance pattern.|Mixed Models Analysis|Unstructured covariance pattern was assumed.||To test whether there were any significant differences between the two treatment groups over time (group vs time interaction), a repeated measurement mixed-model approach was used. This assumed an unstructured covariance pattern.||||0.45
73990995|NCT02232399|147527744|OTHER|||||||0.7|||||||Regression, Logistic|||||||0.70
73990996|NCT01777334|147527746|SUPERIORITY_OR_OTHER||Least squares mean difference|0.112|||<|0.001|TWO_SIDED|95.0|0.081|0.144|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.|||0.144|0.081|<0.001
73990997|NCT00763451|147527761|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED|95.0|-0.583|-0.232||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%) and screening BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.232|-0.583|<0.0001
74009215|NCT05293743|147569204|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.86||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 6.68.||The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by parent-reported brace logs.||||0.86
73990998|NCT00763451|147527761|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.67|-0.317||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%) and screening BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.317|-0.670|<0.0001
73990999|NCT05594589|147527779|SUPERIORITY||Least Squares Geometric Mean(LSGM) Ratio|0.377||||0.0133|TWO_SIDED|95.0|0.175|0.81|||ANCOVA|P-value was based on analysis of covariance (ANCOVA) model with log transformation of baseline LPS and treatment arms as fixed effects.|LSGM ratio was calculated as Lemborexant 5 mg/Placebo.|||0.810|0.175|0.0133
73991000|NCT05594589|147527780|SUPERIORITY||LSGM Ratio|0.48||||0.0619|TWO_SIDED|95.0|0.222|1.038|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSGM ratio was calculated as Lemborexant 10 mg/Placebo.|||1.038|0.222|0.0619
73991001|NCT05594589|147527781|SUPERIORITY||Least Square Mean (LSM) Difference|7.38||||0.0689|TWO_SIDED|95.0|-0.59|15.35|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSM difference was calculated as Lemborexant 5 mg - Placebo.|||15.35|-0.59|0.0689
73991002|NCT05594589|147527782|SUPERIORITY||LSM Difference|8.16||||0.0439|TWO_SIDED|95.0|0.23|16.09|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSM difference was calculated as Lemborexant 10 mg - Placebo.|||16.09|0.23|0.0439
73991003|NCT00087555|147527790|SUPERIORITY_OR_OTHER|||||||0.052||95.0|||||Chi-squared|||||||0.052
73991004|NCT00087555|147527790|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Chi-squared|||||||0.024
73991005|NCT00087555|147527790|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||||||0.035
73991006|NCT02554383|147527803|SUPERIORITY|||||||0.02||||||The interactions (1) between treatment \& pathogens and (2) between treatment \& colored nasal discharge are tested simultaneously.|Mixed Models Analysis|The p value is adjusted for PRSS score at enrollment, diary day, study site, treatment, pathogens, colored nasal discharge \& interaction (2).||Null hypothesis: The effect of treatment with antibiotics does not differ in the subgroups of children defined, respectively, by the presence and by the absence of pathogens in the nasopharynx at enrollment, i.e., there is no significant interaction between treatment and pathogens in the nasopharynx.||||0.02
73991007|NCT02554383|147527803|SUPERIORITY||Difference of least-squares means|-1.95|||||TWO_SIDED|95.0|-2.4|-1.51|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the presence of one or more pathogens in the nasopharynx at enrollment.||-1.51|-2.40|
73991008|NCT02554383|147527803|SUPERIORITY||Difference of least-squares means|-0.88|||||TWO_SIDED|95.0|-1.63|-0.12|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the absence of one or more pathogens in the nasopharynx at enrollment.||-0.12|-1.63|
73991009|NCT02554383|147527804|SUPERIORITY|||||||0.37||||||The interactions (1) between treatment \& pathogens and (2) between treatment \& colored nasal discharge are tested simultaneously.|Mixed Models Analysis|The p value is adjusted for PRSS score at enrollment, diary day, study site, treatment, pathogens, colored nasal discharge \& interaction (1).||Null hypothesis: The effect of treatment with antibiotics does not differ in the subgroups of children defined, respectively, by the presence and by the absence of colored nasal discharge at enrollment, i.e., there is no significant interaction between treatment and colored nasal discharge.||||0.37
73991010|NCT02554383|147527804|SUPERIORITY||Difference of least-squares means|-1.62|||||TWO_SIDED|95.0|-2.09|-1.16|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the presence of colored nasal discharge at enrollment.||-1.16|-2.09|
73991011|NCT02554383|147527804|SUPERIORITY||Difference of least-squares means|-1.7|||||TWO_SIDED|95.0|-2.38|-1.03|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the absence of colored nasal discharge at enrollment.||-1.03|-2.38|
73991012|NCT02554383|147527805|SUPERIORITY|||||||0.003|||||||Log-binomial regression|The p-value is adjusted for study site and and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children experiencing treatment failure.||||0.003
73991013|NCT02554383|147527806|SUPERIORITY|||||||0.007|||||||Fisher Exact|||Null hypothesis: There is no difference between the treatment groups in the proportion of children developing AOM over the first 10 days of follow-up.||||.007
73991014|NCT02554383|147527807|SUPERIORITY||||||<|0.001|||||||Log-binomial regression|The p-value is adjusted for study site and and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children receiving a systemic antibiotic over the first 10 days of follow-up.||||<0.001
73991015|NCT02554383|147527808|SUPERIORITY|||||||0.004|||||||Log-binomial regression|The p-value is adjusted for study site and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children for whom diarrhea or generalized rash was reported.||||0.004
73991016|NCT02554383|147527809|SUPERIORITY|||||||0.75|||||||Log-binomial regression|The p-value is adjusted for presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children compliant with study product.||||0.75
74035351|NCT00779324|147623341|OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
73876202|NCT01272232|147294204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.71|||<|0.0001||95.0|4.76|12.51||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||12.51|4.76|<0.0001
73876203|NCT01272232|147294204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5319||95.0|0.76|1.71||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||1.71|0.76|0.5319
73876204|NCT01272232|147294205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.61|||<|0.0001||95.0|6.05|15.26||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||15.26|6.05|<0.0001
73876205|NCT01272232|147294205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.98|||<|0.0001||95.0|3.59|9.97||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||9.97|3.59|<0.0001
73991017|NCT02554383|147527810|SUPERIORITY|||||||0.63|||||||Log-binomial regression|The p-value is adjusted for study site and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children with a nonsusceptible pathogen at the follow-up visit.||||0.63
73991018|NCT01185171|147527846|NON_INFERIORITY|The power of the study was conducted as a two-stage, non-inferiority phase II trial with a total sample size of 59 patients to detect a 15% lower rate than 80% achieved with TFHX, with alpha = 0.05 and beta = 0.20. In the first stage, 25 patients were recruited, with a plan to terminate if 16 or less complete responses (CR) were observed. Otherwise, additional 34 patients would be recruited and the treatment would be deemed not inferior to historical if more than 45 CRs were observed.|proportion|0.88|||<|0.01|TWO_SIDED|95.0|0.77|0.95||Ho: CR rate = 0.65 vs Ha: CR rate \> 0.65|Binomial test for a proportion|||||0.95|0.77|< 0.01
73991019|NCT00727506|147527851|SUPERIORITY_OR_OTHER|||||||0.148||95.0||||P-value is from an approximate normal test for the 6 month time point.|z-test|||||||0.148
73991020|NCT00727506|147527851|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value is an approximate normal test for the six month time point.|z-test|||||||0.008
73991021|NCT00727506|147527853|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0000
73991022|NCT00727506|147527853|SUPERIORITY_OR_OTHER|||||||0.1954||95.0|||||Fisher Exact|||||||0.1954
73991023|NCT00727506|147527854|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.78||||0.032|TWO_SIDED|95.0|1.088|2.912|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (\<=50 vs. \>50 years old) and baseline Karnofsky Performance Scale (KPS) score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.||2.912|1.088|0.0320
73991024|NCT00727506|147527854|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.392||||0.2044|TWO_SIDED|95.0|0.841|2.301|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (\<=50 vs. \>50 years old) and baseline KPS score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.||2.301|0.841|0.2044
73876206|NCT01272232|147294205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.0142||95.0|1.1|2.34||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.34|1.10|0.0142
73876207|NCT01272232|147294206|SUPERIORITY_OR_OTHER||Treatment contrast|-3.22|||<|0.0001||95.0|-4.2|-2.23||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-2.23|-4.20|<0.0001
73876208|NCT01272232|147294206|SUPERIORITY_OR_OTHER||Treatment contrast|-2.06||||0.0004||95.0|-3.2|-0.92||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.92|-3.20|0.0004
73876209|NCT01272232|147294206|SUPERIORITY_OR_OTHER||Treatment contrast|-1.16||||0.0224||95.0|-2.16|-0.16||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.16|-2.16|0.0224
73991025|NCT00715117|147527881|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
73991026|NCT00715117|147527881|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73991027|NCT00715117|147527882|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Bowel symptoms||||>0.05
73991028|NCT00715117|147527882|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||Social well-being||||0.035
73991029|NCT00715117|147527882|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Emotional well-being||||>0.05
73991030|NCT00715117|147527882|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED|95.0||||Systemic symptoms|t-test, 2 sided|||||||0.035
73991031|NCT00715117|147527882|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Body Image||||>0.05
73991032|NCT00715117|147527883|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Sleep disturbance||||1.0
73991033|NCT00715117|147527883|SUPERIORITY_OR_OTHER|||||||0.45|||||||Fisher Exact|||Unusual dreams||||0.45
73991034|NCT00715117|147527883|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Twitching||||1.0
73991035|NCT00715117|147527883|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Headaches||||1.0
73991036|NCT00715117|147527883|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Decreased appetite||||1.0
73991037|NCT00715117|147527883|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Nausea||||1.0
73991038|NCT00715117|147527883|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Hair loss||||1.0
73991039|NCT00715117|147527883|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Fatigue||||1.0
73991040|NCT00715117|147527883|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Flushed ears||||1.0
73991041|NCT00715117|147527883|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Papules, rash||||1.0
73991042|NCT00715117|147527883|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Double vision||||1.0
73991043|NCT01482429|147527884|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||binomial test|||||||0.03
73991044|NCT01482429|147527885|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73991045|NCT01214421|147527888|SUPERIORITY||Ratio of geometric means (final values)|0.99||||0.358|TWO_SIDED|95.0|0.96|1.02|||Mixed Models Analysis||||Derived from the least squares (LS) mean difference between the treatment groups at each visit using MMRM model with factors of treatment, visit, region, baseline, baseline hypertensive status, baseline renal volume status, baseline creatinine clearance status, interaction of treatment and visit, and interaction of baseline and visit.|1.02|0.96|0.358
73991046|NCT01214421|147527889|SUPERIORITY||LS mean difference (final values)|3.15||||0.0003|TWO_SIDED|95.0|1.462|4.836|||Mixed Models Analysis||||Derived from MMRM analysis with fixed factors of treatment, visit, treatment visit interaction, hypertensive status, renal volume status and creatinine clearance status at baseline, region, baseline value, and baseline visit interaction as covariates, and with a heterogeneous toeplitz variance covariance matrix.|4.836|1.462|0.0003
73991047|NCT01214421|147527890|NON_INFERIORITY|The non-inferiority for early-treatment and delayed-treatment groups.|Ratio of geometric means (final values)|1.011||||0.0462|TWO_SIDED|95.0|1.0|1.023|||Mixed Models Analysis||||Derived from testing interaction of time and treatment using linear mixed model in which intercept and time are treated as random effects.|1.023|1.000|0.0462
73991048|NCT01214421|147527891|NON_INFERIORITY|The non-inferiority for early-treatment and delayed-treatment groups.|Ratio of geometric means (final values)|-0.113||||0.7259|TWO_SIDED|95.0|-0.746|0.52|||Mixed Models Analysis||||Derived from testing interaction of time and treatment using linear mixed model in which intercept and time are treated as random effects.|0.520|-0.746|0.7259
73991049|NCT01214421|147527892|SUPERIORITY||Ratio of geometric means (final values)|0.992||||0.108|TWO_SIDED|95.0|0.982|1.002|||Mixed Models Analysis||||Derived from linear mixed model with terms of participant, treatment, time, interaction of treatment and time, interaction of participant and time, and baseline for intra-participant comparison between 251 and 271. Time and intercept are treated as random effects.|1.002|0.982|0.1080
73991050|NCT01214421|147527893|SUPERIORITY||Ratio of geometric means (final values)|0.361||||0.2265|TWO_SIDED|95.0|-0.224|0.946|||Mixed Models Analysis||||Derived from linear mixed model with terms of participant, treatment, time, interaction of treatment and time, interaction of participant and time, and baseline for intra-participant comparison between 251 and 271. Time and intercept are treated as random effects.|0.946|-0.224|0.2265
73991051|NCT04887506|147528016|EQUIVALENCE|If the 90% confidence interval (CI) fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|||||||The 90% CIs for the geometric mean ratio (GMR) were not evaluable.|Primary analysis of equivalence of TAVT 45 and R AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10).||||
73991052|NCT04887506|147528017|EQUIVALENCE|If the 90% CI fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|0.975|||||TWO_SIDED|90.0|0.944|1.007||||||Supplementary analysis of equivalence of TAVT-45 and R-AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10) in the CS-ITT population.||1.007|0.944|
74035352|NCT00779324|147623342|OTHER||Difference in percents|10.8||||0.1662|TWO_SIDED|95.0|-4.2|25.8|||Chi-squared|||||25.8|-4.2|0.1662
73991053|NCT04887506|147528018|EQUIVALENCE|If the 90% CI fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.978|1.002||||||Supplementary analysis of equivalence of TAVT-45 and R-AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10) in the mITT population.||1.002|0.978|
73991054|NCT04887506|147528019|EQUIVALENCE|Odds ratio generated using the Wald method.|Odds Ratio (OR)|1.69||||0.3408|TWO_SIDED|95.0|0.574|4.979|||Regression, Logistic|||||4.979|0.574|0.3408
73991055|NCT01999777|147528020|SUPERIORITY|||||||0.1972|||||||Wald asymptotic|P-value based on a standard Wald asymptotic test for equality without a continuity correction.||Assumptions included that the proportion of seizures occurring within 6 hours after placebo administration was \~65% and a relative reduction of 50% would result in a reduction of ≥ 32.5 percentage points. Based on a 2-sided 95% confidence interval (CI) for the differences in proportions, a sample size of 62 analyzable subjects was chosen to detect a 0.35 difference between group. Sample size estimations were based on nQuery Version 7.0 using the table for CIs for differences in 2 proportions.||||0.1972
73991056|NCT01999777|147528021|SUPERIORITY|||||||0.1388|||||||Log Rank|||||||0.1388
73991057|NCT01255761|147528048|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 2-sided 95 % CI was greater than -10 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing response to Certolizumab Pegol therapy at 12 weeks.|Difference in proportion|-0.119|||||TWO_SIDED|95.0|-0.184|-0.053||Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.|ANCOVA|Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -10 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."||-0.053|-0.184|
74035353|NCT00779324|147623343|OTHER|||||||0.3488|||||||Wilcoxon (Mann-Whitney)|||||||0.3488
74035354|NCT00779324|147623345|OTHER||Difference in percents|6.4||||0.38|TWO_SIDED|95.0|-7.2|20.0|||Chi-squared|||||20|-7.2|0.38
73876210|NCT01272232|147294207|SUPERIORITY_OR_OTHER||Treatment contrast|-2.17||||0.0002||95.0|-3.32|-1.02||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.02|-3.32|0.0002
73991058|NCT01255761|147528049|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 2-sided 95 % CI was greater than -15 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing percent of Week 12 responders achieving LDA at Week 52.|Difference in proportion|-0.013|||||TWO_SIDED|95.0|-0.093|0.066||Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.|ANCOVA|Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -15 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."||0.066|-0.093|
73991059|NCT03506347|147528087|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
73991060|NCT03506347|147528088|SUPERIORITY|||||||0.009|||||||ANOVA|||||||0.009
73991061|NCT05613088|147528101|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.4063|TWO_SIDED|95.0|0.76|2.0|||Log Rank|||||2.00|0.76|0.4063
73991062|NCT03912532|147528106|OTHER|The Multiple Comparison Procedure-Modelling (MCP-Mod) is a 2-stage procedure in which dose-response models are selected at the design stage. These candidate models are used for both dose-response testing (MCP step) and estimation (Mod step). The dose-response testing is performed using a multiple comparison method to account for the multiplicity issue associated with the multiple candidate models. Missing responses were imputed using multiple imputation under the assumption of missing at random.||||||0.5534|||||||Multiple comparison procedure step|||||||0.5534
73991063|NCT02647645|147528169|SUPERIORITY|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.02||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = 1.78).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, cluster of differentiation (CD4) cell count, and log viral load as covariates.||||0.02
73991064|NCT02647645|147528170|SUPERIORITY|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.34||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .71).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.||||0.34
73876211|NCT01272232|147294207|SUPERIORITY_OR_OTHER||Treatment contrast|-1.2||||0.0725||95.0|-2.51|0.11||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.11|-2.51|0.0725
73991065|NCT02647645|147528171|SUPERIORITY|Power calculation was based on the investigators' estimate of the impact of cognitive training with transcranial direct current stimulation (tDCS) on subjective cognitive problems, as similar studies were not available to develop effect size estimates.||||||0.33||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .63).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.||||0.33
73991066|NCT00356811|147528172|SUPERIORITY_OR_OTHER||percentage of participants|50.9|||||TWO_SIDED|95.0|37.3|64.4|||||The estimated value represents the percentage of participants with a confirmed CR or PR.|||64.4|37.3|
73991067|NCT02825251|147528251|NON_INFERIORITY|Non-inferiority of faster aspart was considered confirmed if the upper limit of the two-sided 95 % CI for the true treatment-difference D (faster aspart minus NovoRapid®) was below 0.4 %.|Treatment difference|0.09|||||TWO_SIDED|95.0|0.01|0.17|||ANOVA|||Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, strata (use of own continuous glucose monitoring), previous insulin use, and region as factors, and baseline HbA1c as a covariate.||0.17|0.01|
73991068|NCT02820597|147528347|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.||Null hypothesis is that the within-participant change from baseline in rTNSS is 0.||||<0.001
73876212|NCT01272232|147294207|SUPERIORITY_OR_OTHER||Treatment contrast|-0.97||||0.0717||95.0|-2.02|0.09||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.09|-2.02|0.0717
73876213|NCT01272232|147294209|SUPERIORITY_OR_OTHER||Treatment contrast|-2.49|||<|0.0001||95.0|-3.75|-1.24||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.24|-3.75|<0.0001
73991069|NCT02820597|147528348|SUPERIORITY||||||<|0.001||||||Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.|t-test, 2 sided|||Null hypothesis is that the within-participant change from baseline in rhinitis symptoms VAS is 0.||||<0.001
73991070|NCT00575042|147528351|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Sample size calculation estimated that with 20 patients, and assuming a 10% drop-out rate, the study would have 80% power to detect a response rate in 35% or more of the study patients. A two-sided p value\<0.05 was considered statistically significant.||||<0.0001
73876214|NCT01272232|147294209|SUPERIORITY_OR_OTHER||Treatment contrast|-1.47||||0.0457||95.0|-2.92|-0.03||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.03|-2.92|0.0457
73991071|NCT03898700|147528354|OTHER||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Performance scores from 31 coaching goals across 7 informal caregivers were used for analysis.||||<0.001
73991072|NCT03898700|147528354|OTHER||Median Difference (Net)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Satisfaction scores from 31 coaching goals across 7 informal caregivers were used for analysis.||||<0.001
73991073|NCT02666664|147528368|SUPERIORITY||Difference in LS mean|-18.1|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-20.0|-16.1|||ANCOVA|||||-16.1|-20|<0.001
73991074|NCT02666664|147528370|SUPERIORITY||Difference in LS mean|-16.1|STANDARD_ERROR_OF_MEAN|1.07|<|0.001|TWO_SIDED|95.0|-18.2|-14.0|||ANCOVA|||||-14|-18.2|<0.001
73991075|NCT02666664|147528371|SUPERIORITY||Difference in LS mean|-13.3|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-15.1|-11.6|||ANCOVA|||||-11.6|-15.1|<0.001
73991076|NCT02666664|147528372|SUPERIORITY||Difference in LS mean|-11.1|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-12.5|-9.8|||ANCOVA|||||-9.8|-12.5|<0.001
73991077|NCT02666664|147528373|SUPERIORITY||Difference in LS mean|-11.9|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-13.6|-10.2|||ANCOVA|||||-10.2|-13.6|<0.001
73876215|NCT01272232|147294209|SUPERIORITY_OR_OTHER||Treatment contrast|-1.02||||0.0961||95.0|-2.22|0.18||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.18|-2.22|0.0961
73991078|NCT02666664|147528374|SUPERIORITY||Location shift|-21.5|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-26.96|-16.0|||Wilcoxon (Mann-Whitney)|||||-16|-26.96|<0.001
73991079|NCT02666664|147528375|SUPERIORITY||Difference in LS mean|-13.6|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-15.8|-11.3|||ANCOVA|||||-11.3|-15.8|<0.001
73991080|NCT02666664|147528384|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73991081|NCT03616964|147528385|SUPERIORITY||Odds Ratio (OR)|1.07||||0.711|TWO_SIDED|95.0|0.75|1.53|||Regression, Logistic|||||1.53|0.75|0.711
73991082|NCT03616964|147528386|SUPERIORITY||Odds Ratio (OR)|1.05||||0.789|TWO_SIDED|95.0|0.73|1.5|||Regression, Logistic|||||1.50|0.73|0.789
73991083|NCT03616964|147528387|SUPERIORITY||Odds Ratio (OR)|1.1||||0.673|TWO_SIDED|95.0|0.72|1.68|||Regression, Logistic|||||1.68|0.72|0.673
73991084|NCT03616964|147528387|SUPERIORITY||Odds Ratio (OR)|1.15||||0.528|TWO_SIDED|95.0|0.75|1.75|||Regression, Logistic|||||1.75|0.75|0.528
73991085|NCT03616964|147528389|SUPERIORITY||Odds Ratio (OR)|0.91||||0.761|TWO_SIDED|95.0|0.51|1.64|||Regression, Logistic|||||1.64|0.51|0.761
73991086|NCT03616964|147528389|SUPERIORITY||Odds Ratio (OR)|1.17||||0.611|TWO_SIDED|95.0|0.65|2.1|||Regression, Logistic|||||2.10|0.65|0.611
73991087|NCT03616964|147528390|SUPERIORITY||LS Mean difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.2||0.698|TWO_SIDED|95.0|-0.47|0.32|||Mixed Models Analysis|||||0.32|-0.47|0.698
73991088|NCT03616964|147528390|SUPERIORITY||LS Mean difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.744|TWO_SIDED|95.0|-0.46|0.33|||Mixed Models Analysis|||||0.33|-0.46|0.744
73876216|NCT00628030|147294220|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Chi-squared|||||||.008
73991089|NCT03616964|147528391|SUPERIORITY||LS Mean difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.84||0.665|TWO_SIDED|95.0|-2.0|1.28|||Mixed Models Analysis|||||1.28|-2.00|0.665
73991090|NCT03616964|147528391|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.84||0.723|TWO_SIDED|95.0|-1.95|1.35|||Mixed Models Analysis|||||1.35|-1.95|0.723
73991091|NCT03616964|147528392|SUPERIORITY||Odds Ratio (OR)|0.69||||0.372|TWO_SIDED|95.0|0.31|1.55|||Regression, Logistic|||||1.55|0.31|0.372
73991092|NCT03616964|147528392|SUPERIORITY||Odds Ratio (OR)|0.78||||0.555|TWO_SIDED|95.0|0.34|1.78|||Regression, Logistic|||||1.78|0.34|0.555
73876217|NCT00628030|147294221|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Chi-squared|||||||.041
73991093|NCT03616964|147528393|SUPERIORITY||LS Mean difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.422||0.251|TWO_SIDED|95.0|-1.31|0.34|||Mixed Models Analysis|||||0.34|-1.31|0.251
73991094|NCT03616964|147528393|SUPERIORITY||LS Mean difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.425||0.333|TWO_SIDED|95.0|-1.74|-0.07|||Mixed Models Analysis|||||-0.07|-1.74|0.333
73991095|NCT03616964|147528394|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.282||0.284|TWO_SIDED|95.0|-0.86|0.25|||Mixed Models Analysis|||||0.25|-0.86|0.284
73991096|NCT03616964|147528394|SUPERIORITY||LS Mean difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.284||0.069|TWO_SIDED|95.0|-1.08|0.04|||Mixed Models Analysis|||||0.04|-1.08|0.069
73991097|NCT01458522|147528438|OTHER|||||||0.512|||||||Poisson regression model|||||||0.512
73991098|NCT04367480|147528478|SUPERIORITY||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.81||0.199|TWO_SIDED|95.0|-0.56|2.67|||ANCOVA|||"Missing data were accounted for using multiple imputation (MI) with the fully conditional specification (FCS) method. 100 replicates were imputed.~ANCOVA analysis was applied within each replicate. SAS PROC MI and MIANALYZE were used to calculate the reported estimates. (N: Active TENS=71, Placebo TENS=70)"||2.67|-0.56|0.199
73991099|NCT04367480|147528479|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.36||0.302|TWO_SIDED|95.0|-0.34|1.08|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.08|-0.34|0.302
73991100|NCT04367480|147528479|SUPERIORITY||Mean Difference (Final Values)|1.37|STANDARD_ERROR_OF_MEAN|0.85||0.112|TWO_SIDED|95.0|-0.33|3.08|||ANCOVA|||Subgroup analysis on participants who reported at least 4 out of 10 at baseline for Hot/Burning Pain. (N: Active TENS=22, Placebo TENS=22)||3.08|-0.33|0.112
74035355|NCT00779324|147623346|OTHER||Difference in percents|11.7||||0.1373|TWO_SIDED|95.0|-3.3|26.7|||Chi-squared|||||26.7|-3.3|0.1373
73991101|NCT04367480|147528480|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.35||0.351|TWO_SIDED|95.0|-0.37|1.02|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.02|-0.37|0.351
73991102|NCT04367480|147528480|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|0.78||0.128|TWO_SIDED|95.0|-0.36|2.79|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Sharp/Shooting Pain. (N: Active TENS=24, Placebo TENS=23)||2.79|-0.36|0.128
73991103|NCT04367480|147528481|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.38||0.166|TWO_SIDED|95.0|-0.22|1.27|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.27|-0.22|0.166
73991104|NCT04367480|147528481|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.39||0.492|TWO_SIDED|95.0|-0.51|1.05|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Numbness. (N: Active TENS=60, Placebo TENS=50)||1.05|-0.51|0.492
73991105|NCT04367480|147528482|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.38||0.622|TWO_SIDED|95.0|-0.56|0.94|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||0.94|-0.56|0.622
73991106|NCT04367480|147528482|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.43||0.587|TWO_SIDED|95.0|-0.61|1.08|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Tingling. (N: Active TENS=55, Placebo TENS=50)||1.08|-0.61|0.587
73991107|NCT04367480|147528483|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.34||0.058|TWO_SIDED|95.0|-0.02|1.31|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.31|-0.02|0.058
73991108|NCT04367480|147528483|SUPERIORITY||Mean Difference (Final Values)|1.35|STANDARD_ERROR_OF_MEAN|0.82||0.11|TWO_SIDED|95.0|-0.32|3.02|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Cramping. (N: Active TENS=18, Placebo TENS=18)||3.02|-0.32|0.110
73991109|NCT02641587|147528488|OTHER|"The analysis will test if the geometric LS mean level of MHBMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|85.01|||<|0.001|TWO_SIDED|95.0|82.06|87.47||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of MHBMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of MHBMA.||87.47|82.06|<0.001
73991110|NCT02641587|147528489|OTHER|"The analysis will test if the geometric LS mean level of 3-HPMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|40.2|||<|0.001|TWO_SIDED|95.0|30.25|48.73||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of 3-HPMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of 3-HPMA.||48.73|30.25|<0.001
73991111|NCT02641587|147528490|OTHER|"The analysis will test if the geometric LS mean level of S-PMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|83.9|||<|0.001|TWO_SIDED|95.0|81.61|85.9||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of S-PMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of S-PMA.||85.90|81.61|<0.001
73991112|NCT02641587|147528491|OTHER|"The analysis will test if the geometric LS mean level of COHb for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|55.74|||<|0.001|TWO_SIDED|95.0|49.03|61.56||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of COHb will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of COHb.||61.56|49.03|<0.001
73991113|NCT02641587|147528492|OTHER|"The analysis will test if the geometric LS mean level of Total NNAL for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|79.36|||<|0.001|TWO_SIDED|95.0|72.73|84.39||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of Total NNAL will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of Total NNAL.||84.39|72.73|<0.001
73991114|NCT01165177|147528493|OTHER|Criteria for the vaccine efficacy (VE) objective of herpes zoster subunit (HZ/su) vaccine against herpes zoster (HZ) disease, in the 50-59 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|96.6|||<|0.0001|TWO_SIDED|95.0|89.6|99.3||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group||99.3|89.6|<0.0001
73991115|NCT01165177|147528493|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 60-69 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.4|||<|0.0001|TWO_SIDED|95.0|90.1|99.7||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 60-69 YOA group and placebo over 60-69 YOA group||99.7|90.1|<0.0001
73991116|NCT01165177|147528493|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 70-79 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.9||||0.0001|TWO_SIDED|95.0|87.9|100.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 70 YOA group and placebo over 70 YOA group||100|87.9|0.0001
73991117|NCT01165177|147528493|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the overall age strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.2|||<|0.0001|TWO_SIDED|95.0|93.7|99.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A overall ages group and placebo overall ages group||99|93.7|<0.0001
73991118|NCT01165177|147528494|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the 50-59 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.0081|TWO_SIDED|95.0|40.9|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group||100|40.9|0.0081
74035356|NCT00779324|147623347|OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
73876218|NCT00628030|147294222|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Chi-squared|||||||.61
73991119|NCT01165177|147528494|OTHER|Criteria for VE objective of HZ/su vaccine against PHN in the 60-69 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.5097|TWO_SIDED|95.0|-442.8|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 60-69 YOA group and placebo 60-69 YOA group||100|-442.8|0.5097
73991120|NCT01165177|147528494|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the 70-79 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.0078|TWO_SIDED|95.0|41.4|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A over 70 YOA group and placebo over 70 YOA group||100|41.4|0.0078
73991121|NCT01165177|147528494|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the overall ages strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0|||<|0.0001|TWO_SIDED|95.0|77.1|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A overall ages group and placebo overall ages group||100|77.1|<0.0001
74035357|NCT00779324|147623348|OTHER|||||||0.0353|||||||Wilcoxon (Mann-Whitney)|||||||0.0353
74035358|NCT00677690|147623366|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||"All data were expressed as the mean ± SD. The level of significance for all tests was set at p \< 0.05.~Inter- and intra-group comparisons were performed using both paired and unpaired t tests for continuous variables and Chi squared for categorical variables."||||< 0.05
74035359|NCT00677690|147623367|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
74035360|NCT00677690|147623368|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
74035361|NCT00677690|147623369|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
74035362|NCT00677690|147623370|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
73876219|NCT00628030|147294223|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||0.13
73876220|NCT00628030|147294224|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||||||.024
73991122|NCT00634842|147528515|NON_INFERIORITY_OR_EQUIVALENCE|The primary hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level \< 7% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|1.86||||0.0411||95.0|1.03|3.37|||Test for Difference in Proportions|||To show non-inferiority for the primary endpoint, 100 subjects per group provides 80% power to show that the 95% CI for the difference of proportions between treatments is within the 20% margin under the assumption of equality of proportions. It is also sufficient to show superiority under the assumption that the first proportion is greater than the second by at least 20%. With a predicted withdrawal rate of 15%, 236 subjects were needed based on a treatment ratio of 1:1 for the two treatments.||3.37|1.03|0.0411
73991123|NCT00634842|147528516|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level \<= 6.5% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|2.34||||0.0064||95.0|1.27|4.3|||Regression, Logistic|||||4.30|1.27|0.0064
73991124|NCT00634842|147528517|SUPERIORITY_OR_OTHER||LSMean|-0.271||||0.0019||95.0|-0.441|-0.101|||ANCOVA|The analyses for HbA1c were adjusted for baseline HbA1c values.||||-0.101|-0.441|0.0019
73991125|NCT01642147|147528519|SUPERIORITY_OR_OTHER|||||||0.554||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same before anesthesia.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||0.554
73991126|NCT01642147|147528520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same at extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
73991127|NCT01642147|147528521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 30min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
73991128|NCT01642147|147528522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 60min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
73991129|NCT01642147|147528523|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 90min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
73991130|NCT01642147|147528524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 120min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
73991131|NCT04182113|147528550|SUPERIORITY||Mean Difference (Net)|-0.042||||0.32|TWO_SIDED|95.0|-0.129|0.044||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test comparing Target vs. Foil activity following 1Hz rTMS to Target vs. Foil activity following 20 Hz rTMS stimulation.||0.044|-0.129|0.32
73991132|NCT04182113|147528550|SUPERIORITY||Mean Difference (Net)|0.043||||0.25|TWO_SIDED|95.0|-0.03|0.12||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test between Target vs. Foil activation following 1 Hz rTMS and Target vs. Foil activation following Sham stimulation..||0.12|-0.03|0.25
73991133|NCT04182113|147528550|SUPERIORITY||Mean Difference (Net)|0.078||||0.13|TWO_SIDED|95.0|-0.024|0.181||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test between Target vs. Foil activity following 20 Hz rTMS and Target vs. Foil activity following Sham stimulation.||0.181|-0.024|0.13
73991134|NCT04182113|147528551|SUPERIORITY||Mean Difference (Net)|0.018||||0.038|TWO_SIDED|95.0|0.001|0.034||Not corrected for multiple comparisons.|t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 1Hz rTMS to precuneus connectivity following 20 Hz rTMS stimulation.||0.034|0.001|0.038
73991135|NCT04182113|147528551|SUPERIORITY||Mean Difference (Net)|0.009||||0.44|TWO_SIDED|95.0|-0.015|0.033|||t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 1Hz rTMS to precuneus connectivity following 20 Hz rTMS stimulation.||0.033|-0.015|0.44
73991136|NCT04182113|147528551|SUPERIORITY||Mean Difference (Net)|-0.012||||0.25|TWO_SIDED|95.0|-0.032|0.009|||t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 20Hz rTMS to precuneus connectivity following sham stimulation.||0.009|-0.032|0.25
73991137|NCT04182113|147528552|SUPERIORITY||Mean Difference (Net)|2.7||||0.2|TWO_SIDED|95.0|-1.6|6.9||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 1Hz rTMS to accuracy following 20 Hz rTMS.||6.9|-1.6|0.20
73991138|NCT04182113|147528552|SUPERIORITY||Mean Difference (Net)|4.0||||0.17|TWO_SIDED|95.0|-1.9|9.9||Not corrected for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 1Hz rTMS to accuracy following sham rTMS.||9.9|-1.9|0.17
74035363|NCT01106625|147623375|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-0.904|-0.524|||ANCOVA|||||-0.524|-0.904|<0.001
73876221|NCT03367858|147294240|SUPERIORITY|||||||0.0173||||||At 12 month follow up.|ANCOVA|||We conducted a repeated measures ANCOVA of Time (Post-Treatment: 3, 6, 12 months) × Treatment (MI, BAM) with the covariate of pre-treatment problem drinking.||||.0173
73876222|NCT03827655|147294291|SUPERIORITY||Hazard Ratio (HR)|0.92|||=|0.649|TWO_SIDED|90.0|0.63|1.33||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% confidence intervals (CIs) and associated Wald Chi-square p-values between TAK-954 dose levels and placebo were obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.33|0.63|=0.649
73991139|NCT04182113|147528552|SUPERIORITY||Mean Difference (Net)|-1.3||||0.77|TWO_SIDED|95.0|-10.8|8.2||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 20Hz rTMS to accuracy following 20 Hz rTMS.||8.2|-10.8|0.77
73991140|NCT01667406|147528553|OTHER|Fishers exact conditional test was used to confirm significance|Mean Difference (Final Values)|6.0|||||ONE_SIDED|95.0||||||||Data presented using descriptive statistics. Confidence intervals were derived for the difference between the means of different doses.||||
73991141|NCT01667406|147528553|OTHER||||||<|0.05|||||||Fisher Exact|||Phase 2||||<0.05
73991142|NCT01667406|147528553|OTHER||Odds Ratio (OR)|0.05|||<|0.05|ONE_SIDED|95.0|||||Regression, Logistic||Estimate of difference in success rates and estimate of odds ratio for success were derived, with P value comparing 2 treatment groups, 95% conﬁdence intervals.|Phase 3||||<0.05
73991143|NCT01667406|147528554|OTHER|secondary outcomes were analysed using descriptive statistics.||||||||||||||||Study data were summarised using standard descriptive methods. Continuous variables following a normal distribution have been summarised using mean and SD.|secondary outcomes were analysed using descriptive statistics.|||
73991144|NCT04294667|147528571|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the Cochran-Mantel-Haenszel (CMH) risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|14.6||||0.011|TWO_SIDED|95.0|3.3|25.8|||Cochran-Mantel-Haenszel|||||25.8|3.3|0.0110
73991145|NCT04294667|147528572|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|7.9||||0.1776|TWO_SIDED|95.0|-3.6|19.4|||Cochran-Mantel-Haenszel|||||19.4|-3.6|0.1776
73991146|NCT04294667|147528573|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|10.8||||0.0518|TWO_SIDED|95.0|-0.1|21.7|||Cochran-Mantel-Haenszel|||||21.7|-0.1|0.0518
73991147|NCT04294667|147528574|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|11.5||||0.0257|TWO_SIDED|95.0|1.4|21.6|||Cochran-Mantel-Haenszel|||||21.6|1.4|0.0257
73991148|NCT04294667|147528575|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the Cochran-Mantel-Haenszel (CMH) risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|7.2||||0.1042|TWO_SIDED|95.0|-1.5|16.0|||Cochran-Mantel-Haenszel|||||16.0|-1.5|0.1042
73991149|NCT04294667|147528576|SUPERIORITY||Difference of Change(DZP+SOC vs PBO+SOC)|-1.8||||0.0001|TWO_SIDED|95.0|-2.7|-0.9|||MMRM|The Least Squares (LS) Mean, the difference (DZP+SOC versus PBO+SOC), and the 95% CIs was computed from the MMRM.||||-0.9|-2.7|0.0001
73991150|NCT04294667|147528581|SUPERIORITY|||||||0.0111|||||||Log Rank|||||||0.0111
73991151|NCT04294667|147528582|SUPERIORITY|||||||0.0228|||||||Log Rank|||||||0.0228
73991152|NCT02818998|147528607|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|0.01|||<|0.0001|TWO_SIDED|95.0|-1.46|1.47||Non-inferiority was demonstrated if the p-value (adjusted for multiplicity using the Hochberg procedure) was \< 0.025|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||1.47|-1.46|<0.0001
73991153|NCT02818998|147528607|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|0.95|||<|0.0001|TWO_SIDED|95.0|-0.52|2.42||Non-inferiority was demonstrated if the p-value (adjusted for multiplicity using the Hochberg procedure) was \< 0.025|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||2.42|-0.52|<0.0001
73991154|NCT02818998|147528608|OTHER||Least Square mean difference|14.38||||0.0105|TWO_SIDED|95.0|3.39|25.37|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||25.37|3.39|0.0105
73991155|NCT02818998|147528608|OTHER||Least Square mean difference|21.22||||0.0023|TWO_SIDED|95.0|7.65|34.8|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||34.80|7.65|0.0023
73991156|NCT02818998|147528609|OTHER||Treatment Difference|0.68|||||TWO_SIDED|95.0|-3.14|4.49|||Cochran-Mantel-Haenszel|||≥ 15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||4.49|-3.14|
73991157|NCT02818998|147528609|OTHER||Treatment Difference|2.66|||||TWO_SIDED|95.0|-3.4|8.73|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||8.73|-3.40|
73991158|NCT02818998|147528609|OTHER||Treatment Difference|-0.66|||||TWO_SIDED|95.0|-1.94|0.63|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||0.63|-1.94|
73876223|NCT03827655|147294291|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.505|TWO_SIDED|90.0|0.69|1.43||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.43|0.69|=0.505
73991159|NCT02818998|147528609|OTHER||Treatment Difference|-0.13|||||TWO_SIDED|95.0|-3.68|3.41|||Cochran-Mantel-Haenszel|||≥15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||3.41|-3.68|
73991160|NCT02818998|147528609|OTHER||Treatment Difference|1.72|||||TWO_SIDED|95.0|-4.1|7.54|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||7.54|-4.10|
73991161|NCT02818998|147528609|OTHER||Treatment Difference|-0.68|||||TWO_SIDED|95.0|-2.0|0.65|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||0.65|-2.00|
73991162|NCT02818998|147528610|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-2.13|1.52|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||1.52|-2.13|<0.0001
73991163|NCT02818998|147528610|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|1.39|||<|0.0001|TWO_SIDED|95.0|-0.4|3.19|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||3.19|-0.40|<0.0001
73991164|NCT02818998|147528611|OTHER||Least Square mean difference|16.14||||0.0416|TWO_SIDED|95.0|0.62|31.66|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||31.66|0.62|0.0416
73991165|NCT02818998|147528611|OTHER||Least Square mean difference|4.12||||0.5524|TWO_SIDED|95.0|-9.52|17.77|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||17.77|-9.52|0.5524
73991166|NCT02818998|147528612|OTHER||Treatment Difference|0.67|||||TWO_SIDED|95.0|-2.72|4.05|||Cochran-Mantel-Haenszel|||≥ 15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||4.05|-2.72|
73991167|NCT02818998|147528612|OTHER||Treatment Difference|4.63|||||TWO_SIDED|95.0|-1.73|10.98|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||10.98|-1.73|
73991168|NCT02818998|147528612|OTHER||Treatment Difference|0.66|||||TWO_SIDED|95.0|-1.56|2.87|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||2.87|-1.56|
73991169|NCT02818998|147528612|OTHER||Treatment Difference|1.9|||||TWO_SIDED|95.0|-1.89|5.69|||Cochran-Mantel-Haenszel|||≥15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||5.69|-1.89|
73991170|NCT02818998|147528612|OTHER||Treatment Difference|7.54|||||TWO_SIDED|95.0|0.81|14.28|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||14.28|0.81|
73991171|NCT02818998|147528612|OTHER||Treatment Difference|0.63|||||TWO_SIDED|95.0|-1.61|2.88|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||2.88|-1.61|
73991172|NCT00632021|147528615|EQUIVALENCE|In the primary analysis we compared the number of clinically important medication errors by treatment group using unadjusted negative binomial regression.|Incidence Rate Ratio (IRR)|0.92|||||TWO_SIDED|95.0|0.77|1.09||||||||1.09|0.77|
73991173|NCT00632021|147528616|EQUIVALENCE|The association between intervention and time to first unplanned health care event (hospital readmission) was examined using multivariable Cox proportional hazards regression models.|Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.63|1.28||||||||1.28|0.63|
73991174|NCT03563313|147528617|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73991175|NCT03563313|147528618|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73991176|NCT03563313|147528619|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73991177|NCT03563313|147528620|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
73991178|NCT03563313|147528621|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73991179|NCT03563313|147528622|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
73991180|NCT00458393|147528670|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.577|STANDARD_ERROR_OF_MEAN|0.105||0.002|TWO_SIDED|95.0|0.404|0.824||secondary p-value given.|Log Rank|stratified by site|Efron correction for ties. Placebo is reference. Results typically quoted as efficacy = 100\*(1-HR)|Primary null hypothesis: Relative hazard of 0.7 or less. Secondary null hypothesis: Relative hazard of 1.0 or less.||.824|.404|0.002
73991181|NCT00458393|147528671|SUPERIORITY||Risk Ratio (RR)|1.33||||0.28|TWO_SIDED|95.0|0.79|2.25||p-value is not adjusted for multiple comparisons, a priori threshold for statistical significance was p \< 0.05|Fisher Exact||||Extensive analysis and methods published in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966916/|2.25|0.79|0.28
73991182|NCT00458393|147528672|SUPERIORITY||Risk Ratio (RR)|1.3||||0.54|TWO_SIDED|95.0|0.57|2.96|||Fisher Exact|||||2.96|.57|0.54
73991183|NCT00458393|147528673|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.5|TWO_SIDED|95.0|0.65|1.23|||Log Rank|||||1.23|0.65|0.50
73991184|NCT00458393|147528674|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.92|TWO_SIDED|95.0|0.79|1.23|||Log Rank|||||1.23|0.79|0.92
73991185|NCT00458393|147528675|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Null hypothesis of no difference||||1.00
73991186|NCT00458393|147528675|SUPERIORITY|Desc|Risk Difference (RD)|0.0||||1|TWO_SIDED||||||Fisher Exact|||||||1.00
73991187|NCT00458393|147528676|SUPERIORITY||Mean Difference (Net)|-0.91||||0.001|TWO_SIDED|||||\< 0.05 for statistical significance. no adjustment for multiple comparisons|Mixed Models Analysis|||||||0.001
73991188|NCT00458393|147528677|SUPERIORITY||Median Difference (Net)|-3.8||||0.009|TWO_SIDED|95.0|-6.6|-0.95|||median regression|||||-0.95|-6.6|0.009
73991189|NCT00458393|147528678|SUPERIORITY||Median Difference (Net)|0.0||||1|TWO_SIDED|95.0|-9.3|9.3|||median regression|||||9.3|-9.3|1.00
73991190|NCT00458393|147528679|SUPERIORITY||Median Difference (Net)|-2.2||||0.19|TWO_SIDED|95.0|-5.5|1.1|||median regression|||||1.1|-5.5|0.19
73991191|NCT00458393|147528680|SUPERIORITY||Mean Difference (Net)|0.08||||0.56|TWO_SIDED|95.0|-0.18|0.33|||t-test, 2 sided|||||0.33|-.18|0.56
73876224|NCT03827655|147294292|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.449|TWO_SIDED|90.0|0.71|1.49||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.49|0.71|=0.449
73876225|NCT03827655|147294292|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.507|TWO_SIDED|90.0|0.69|1.44||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.44|0.69|=0.507
73991192|NCT00458393|147528681|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||Null hypothesis is the proportion of mutations is identical.|Detailed resistance data is found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176446/|||1.00
73991193|NCT00458393|147528682|SUPERIORITY||Mean Difference (Net)|-7.0||||0.32|TWO_SIDED|95.0|-69.0|54.0|||Mixed Models Analysis|||||54|-69|0.32
73991194|NCT00458393|147528683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.005||||0.53|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||Null hypothesis is equal proportion of pills returned||0.01|-0.02|0.53
73991195|NCT00458393|147528684|SUPERIORITY||Mean Difference (Net)|0.25||||0.7|TWO_SIDED|95.0|-1.1|1.6|||t-test, 2 sided||||Detailed methods and results are available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110718/|1.6|-1.1|0.70
73991196|NCT00458393|147528685|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|||||Not adjusted for multiple comparisons and the a priori threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
73991197|NCT00458393|147528686|SUPERIORITY||Median Difference (Final Values)|0.0||||0.76|TWO_SIDED|95.0|-0.42|0.42||Not adjusted for multiple comparisons, a priori threshold for statistical significance, p \< 0.05|Wilcoxon (Mann-Whitney)||||Full details available in the methods section of https://www.ncbi.nlm.nih.gov/pubmed/24367497|.42|-.42|0.76
73991198|NCT00458393|147528687|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.008||||0.68|TWO_SIDED|95.0|-0.047|0.03|||Chi-squared|||Null is no difference between arms||0.030|-0.047|0.68
73876226|NCT03827655|147294293|SUPERIORITY||Hazard Ratio (HR)|1.05|||=|0.406|TWO_SIDED|90.0|0.73|1.52||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.52|0.73|=0.406
73991199|NCT00458393|147528688|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13||||0.3|TWO_SIDED|95.0|0.89|1.43|||Log Rank|||Null hypothesis of no difference between the arms||1.43|0.89|0.30
73991200|NCT00458393|147528689|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.41|TWO_SIDED|95.0|0.8|1.7|||Log Rank||||Details in the manuscript https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956614/|1.7|0.8|0.41
73991201|NCT00458393|147528690|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.09|TWO_SIDED|95.0|0.34|1.09|||Log Rank|||||1.09|0.34|0.09
73991202|NCT05043883|147528699|SUPERIORITY|This clinical investigation is intended to demonstrate that the performance of the PVI Analyzer software is superior to clinically relevant performance level, and therefore the study is designed as a 1-sample superiority test of the sampled outcome specificity. The lower bound 95% CI (α=0.05) and at a statistical power of 95% (β=0.05).|Percentage (%)|87.0||||0.006|ONE_SIDED|95.0||||The success of the PVI Analyzer output was assumed to follow a binominal distribution with a given true proportion of 87.50%. It was tested whether the specificity was superior to the 80% limit.|Z-test|A one-tailed test with a significance level of 95% (α = 0.05) was applied.||Specificity is the ability to correctly detect true negative values of the ground-truth negative EGM classifications. The PVI Analyzer software classifies an EGM in positive (isolated) or negative (non-isolated), compared to the SOC outcomes. EGMs prior-isolation were labeled as ground-truth negative (non-isolated), EGMs after isolation as ground-truth positive (isolated). The null hypothesis is that specificity is lower or equal to the superiority limit 80%.||||0.006
73991203|NCT05043883|147528699|SUPERIORITY|This clinical investigation is intended to demonstrate that the performance of the PVI Analyzer software is superior to clinically relevant performance level, and therefore the study is designed as a 1-sample superiority test of the sampled outcome Sensitivity. The lower bound 95% CI (α=0.05) and at a statistical power of 95% (β=0.05).|Percentage|86.0||||0.004|ONE_SIDED|95.0||||The success of the PVI Analyzer output was assumed to follow a binominal distribution with a given true proportion of 87.50%. It was tested whether the sensitivity was superior to the 80% limit.|Z-test|A one-tailed test with a significance level of 95% (α = 0.05) was applied.||Sensitivity of the PVI analyzer is determined by the capability to detect true positive among all ground-truth positive EGM classifications.The PVI Analyzer software classifies an EGM in positive (isolated) or negative (non-isolated), compared to the SOC outcomes. EGMs prior-isolation were labeled as ground-truth negative (non-isolated), EGMs after isolation as ground-truth positive (isolated). The null hypothesis is that sensitivity is lower or equal to the superiority limit 80%.||||0.004
73991204|NCT05043883|147528700|OTHER|Descriptive|Percentage|0.99|STANDARD_DEVIATION|0.1|||TWO_SIDED|95.0|0.02|5.39|||||Only one AE was reported for one subject ( which was considered moderate in severity and not related to the device, but related to the SOC procedure.|A descriptive analysis was performed to evaluate the AEs and device deficiencies, estimating the percentages and 95% CI on each category.||5.39|0.02|
73991205|NCT05043883|147528701|SUPERIORITY||Percentage (%)|94.0||||2e-05|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that specificity is below 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Radiofrequency procedure from EP procedure until study completion at discharge (an average of 24 hours), with a specificity superior to 80%. A superiority Z-test for Specificity was performed.||||0.00002
74035364|NCT01106625|147623375|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-1.114|-0.732|||ANCOVA|||||-0.732|-1.114|<0.001
73876227|NCT03827655|147294293|SUPERIORITY||Hazard Ratio (HR)|0.77|||=|0.88|TWO_SIDED|90.0|0.54|1.11||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.11|0.54|=0.880
73991206|NCT05043883|147528701|SUPERIORITY||Percentage (%)|82.0||||0.32|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that sensitivity is below 80% and alternative hypothesis that sensitivity is at or above 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Radiofrequency procedure from EP procedure until study completion at discharge (an average of 24 hours), with sensitivity superior to 80%. A superiority Z-test for Sensitivity was performed.||||0.32
73991207|NCT05043883|147528701|SUPERIORITY||Percentage (%)|79.0||||0.66|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that specificity is below 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Cryo-balloon procedure from EP procedure until study completion at discharge (an average of 24 hours), with a specificity superior to 80%. A superiority Z-test for Specificity was performed.||||0.66
73991208|NCT05043883|147528701|SUPERIORITY||Percentage (%)|92.0||||0.0008|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that sensitivity is below 80% and alternative hypothesis that sensitivity is at or above 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Cryo-balloon procedure from EP procedure until study completion at discharge (an average of 24 hours), with a sensitivity superior to 80%. A superiority Z-test for Sensitivity was performed.||||0.0008
73991209|NCT05043883|147528702|SUPERIORITY||Percentage (%)|96.0||||5e-06|TWO_SIDED|||||To compute the proportional agreement between two non-overlapping samples, a one-sample Z-test was performed with the alternative hypothesis that agreement was above 90%, which was considered sufficient for a real-time assessment.|Z-test|||This endpoint used the same EGMs extracted for the primary endpoint, including only EGMs from T Baseline and T Final measurements from patients in sinus rhythm.||||0.000005
74035365|NCT01106625|147623376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.42|||<|0.001|TWO_SIDED|95.0|2.48|7.87|||Regression, Logistic|||||7.87|2.48|<0.001
74035366|NCT01106625|147623376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.8|||<|0.001|TWO_SIDED|95.0|4.86|15.95|||Regression, Logistic|||||15.95|4.86|<0.001
73991210|NCT05043883|147528703|SUPERIORITY||Percentage (%)|54.0||||1|TWO_SIDED|||||The p values calculated are the result of running a one sample z-test with a null hypothesis that the specificity are below 80%.|Z-test|||The data analysis and processing were similar to those of the primary endpoint, but taking into consideration that subjects shall be in non-sinus rhythm during the duration of the EGM snippet. Apart from this, the processing was the same and the threshold was also defined as 50: values below 50 were classified as baseline, while values at or above 50 were considered as isolated veins.||||1
73991211|NCT05043883|147528703|SUPERIORITY||Percentage (%)|100.0||||0.0007|TWO_SIDED|||||The p values calculated are the result of running a one sample z-test with a null hypothesis that the sensitivity are below 80% and an alternative hypothesis that sensitivity is at or above 80%.|Z-test|||The data analysis and processing were similar to those of the primary endpoint, but taking into consideration that subjects shall be in non-sinus rhythm during the duration of the EGM snippet. Apart from this, the processing was the same and the threshold was also defined as 50: values below 50 were classified as baseline, while values at or above 50 were considered as isolated veins.||||0.0007
73991212|NCT05043883|147528704|SUPERIORITY||Percentage (%)|87.0||||0.04|TWO_SIDED||||||Z-test|The estimate was done using a one-sample Z-test with a null hypothesis that sensitivity is at or below 80% and a 95% significance level.||This secondary endpoint aimed to determine the sensitivity of the PVI Analyzer at the time of isolation, which requires the EGMs at the T PVI. A Z-test for sensitivity was performed to assess the sensitivity of the PVI Analyzer analysis to identify expert-defined isolation during the PVI ablation.||||0.04
74035367|NCT01106625|147623377|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|4.627|<|0.001|TWO_SIDED|95.0|-31.53|-13.16|||ANCOVA|||||-13.16|-31.53|<0.001
74035368|NCT01106625|147623377|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-34.6|STANDARD_ERROR_OF_MEAN|4.692|<|0.001|TWO_SIDED|95.0|-43.86|-25.42|||ANCOVA|||||-25.42|-43.86|<0.001
74035369|NCT01106625|147623378|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.1|-0.7|||ANCOVA|||||-0.7|-2.1|<0.001
74035370|NCT01106625|147623378|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.7|-1.3|||ANCOVA|||||-1.3|-2.7|<0.001
74035371|NCT01106625|147623379|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|1.262||0.077|TWO_SIDED|95.0|-4.719|0.241|||ANCOVA|||||0.241|-4.719|0.077
74035372|NCT01106625|147623379|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|1.266||0.201|TWO_SIDED|95.0|-4.111|0.866|||ANCOVA|||||0.866|-4.111|0.201
74035373|NCT01106625|147623380|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|5.4||0.256|TWO_SIDED|95.0|-16.9|4.5|||ANCOVA|||||4.5|-16.9|0.256
73991213|NCT05043883|147528705|OTHER|||||||0.0002||||||McNemar test assumes as a null hypothesis that the two datasets cause the PVI Analyzer to have a similar proportion of errors.|McNemars test|A paired McNemars test with an alpha value of 0.05, was applied to analyze the differences in classification performance.||A paired McNemar's Chi-Square test was performed to analyze the differences in classification performances||||0.0002
74035374|NCT01106625|147623380|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.5||0.571|TWO_SIDED|95.0|-13.8|7.6|||ANCOVA|||||7.6|-13.8|0.571
73876228|NCT03827655|147294294|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.446|TWO_SIDED|90.0|0.72|1.48||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.48|0.72|=0.446
73991214|NCT01587118|147528706|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance was p\</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.||||||<.0001
73991215|NCT01587118|147528707|SUPERIORITY_OR_OTHER|||||||0.0006||||||The a priori threshold for statistical significance was p\</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.||||||.0006
74035375|NCT01106625|147623381|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.7||0.153|TWO_SIDED|95.0|-0.9|5.9|||ANCOVA|||||5.9|-0.9|0.153
74035376|NCT01106625|147623381|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|1.8||0.056|TWO_SIDED|95.0|-0.1|6.8|||ANCOVA|||||6.8|-0.1|0.056
73876229|NCT03827655|147294294|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.892|TWO_SIDED|90.0|0.53|1.09||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.09|0.53|=0.892
73876230|NCT03827655|147294295|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.76|TWO_SIDED|90.0|0.6|1.23||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.23|0.60|=0.760
73991216|NCT00537329|147528708|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|86.1||||||95.0|70.5|95.3||||||Sample size enrollment of 100 subjects was planned. Assuming an overall response rate of 75 percent (%), a 95% confidence interval (CI) for the percentage of subjects responding to treatment would have ranged from 66.3% to 83.7% allowing for 5% nonevaluability. This would have provided a level of precision considered acceptable for this Asian regional study.||95.3|70.5|
73991217|NCT00537329|147528709|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|89.2||||||95.0|74.6|97.0||||||EOIT||97.0|74.6|
73991218|NCT00537329|147528709|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|82.8||||||95.0|64.2|94.2||||||2 Wks post EOT||94.2|64.2|
73991219|NCT00537329|147528709|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|89.5||||||95.0|66.9|98.7||||||6 Wks post EOT||98.7|66.9|
73991220|NCT00537329|147528709|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|72.7||||||95.0|49.8|89.3||||||12 Wks post baseline||89.3|49.8|
73991221|NCT00537329|147528710|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOIT: success (cure/improvement)||99.9|85.1|
73876231|NCT03827655|147294295|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.81|TWO_SIDED|90.0|0.58|1.18||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-squared test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.18|0.58|=0.810
73991222|NCT00537329|147528710|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.1||||||95.0|80.3|99.3||||||EOT: success (cure/improvement)||99.3|80.3|
73991223|NCT00537329|147528710|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|92.9||||||95.0|76.5|99.1||||||2 Wks post EOT: success (cure/improvement)||99.1|76.5|
73991224|NCT00537329|147528710|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (cure/improvement)||99.9|72.7|
73991225|NCT00537329|147528710|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|85.0||||||95.0|62.1|96.8||||||12 Wks post baseline: success (cure/improvement)||96.8|62.1|
73991226|NCT00537329|147528711|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.3||||||95.0|85.8|99.9||||||EOIT: success (erad/presumed erad)||99.9|85.8|
73991227|NCT00537329|147528711|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOT: success (erad/presumed erad)||99.9|85.1|
73991228|NCT00537329|147528711|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|86.2||||||95.0|68.3|96.1||||||2 Wks post EOT: success (erad/presumed erad)||96.1|68.3|
73991229|NCT00537329|147528711|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (erad/presumed erad)||99.9|72.7|
73991230|NCT00537329|147528711|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|84.2||||||95.0|60.4|96.6||||||12 Wks post baseline: success (erad/presumed erad)||96.6|60.4|
73991231|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|50.0||||||95.0|1.3|98.7||||||Neutropenic status: ANC ≤ 500/cmm||98.7|1.3|
73991232|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|75.7||||||95.0|58.8|88.2||||||Neutropenic status: ANC \> 500/cmm||88.2|58.8|
73991233|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|41.9|91.6||||||Baseline pathogen: Candida albicans||91.6|41.9|
73991234|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|66.7||||||95.0|22.3|95.7||||||Baseline pathogen: Candida glabrata||95.7|22.3|
73991235|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|39.8|100.0||||||Baseline pathogen: Candida parapsilosis||100.0|39.8|
73991236|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|2.5|100.0||||||Baseline pathogen: Candida rugosa||100.0|2.5|
73991237|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|72.2||||||95.0|46.5|90.3||||||Baseline pathogen: Candida tropicalis||90.3|46.5|
73991238|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|84.6||||||95.0|54.6|98.1||||||Previous surgery: Any surgery||98.1|54.6|
73991239|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|87.5||||||95.0|47.3|99.7||||||Previous surgery: Abdominal surgery||99.7|47.3|
73991240|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|58.8||||||95.0|32.9|81.6||||||Elderly: Age ≥ 65 years||81.6|32.9|
73991241|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|54.5||||||95.0|23.4|83.3||||||Renal insufficiency (CCC \< 30 mL/min)||83.3|23.4|
73991242|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|81.0||||||95.0|58.1|94.6||||||Use of Central venous catheter = Yes||94.6|58.1|
73991243|NCT00537329|147528718|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|29.0|96.3||||||Receiving chemotherapy = Yes||96.3|29.0|
73991244|NCT03178045|147528751|OTHER|Multivariable Logistic Regression|Estimated Increase|0.23|||||TWO_SIDED|95.0|-3.1|3.6||||||||3.6|-3.1|
73876232|NCT03827655|147294296|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.288|TWO_SIDED|90.0|0.78|1.64||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.64|0.78|=0.288
73991245|NCT03178045|147528752|OTHER|Multivariable logistic regression|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.69|1.31||||||||1.31|0.69|
73991246|NCT03178045|147528753|OTHER|Longitudinal mixed effects regression|Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.6|1.32||||||||1.32|0.60|
73991247|NCT03432390|147528765|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.0001
74035377|NCT02196038|147623394|SUPERIORITY||Mean Difference (Final Values)|1.5|||<|0.0001|TWO_SIDED|95.0|0.9|2.0|||joint model|Joint model of ANCOVA plus survival||||2.0|0.9|<0.0001
74035378|NCT02196038|147623395|SUPERIORITY||Rate Ratio|0.93||||0.59|TWO_SIDED|95.0|0.66|1.19|||Joint Model|Joint model of Poisson regression and survival||||1.19|0.66|0.59
73991248|NCT00267098|147528782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.729||||0.999|TWO_SIDED|95.0|0.592|0.889||BLOCK HF is a Bayesian study;a p-value was not used. Instead, a posterior probability,representing the probability that patients with BiV pacing have lower risk of events than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time until death, a HF urgent care event or visit in which the LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality, a heart failure urgent care visit, or significant increase in LVESVI as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a lower rate of this composite endpoint than patients with right ventricular pacing.||0.889|0.592|0.9990
73991249|NCT00267098|147528783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.843||||0.865|TWO_SIDED|95.0|0.632|1.142||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, posterior probabilities, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio for death can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality as corresponding patients who receive right ventricular pacing.||1.142|0.632|0.865
74009216|NCT05293743|147569204|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.21||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 6.94.||The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by iButton temperature sensors.||||0.21
74009217|NCT01380730|147569255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.1|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-71.48|-60.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.72|-71.48|<0.001
74009218|NCT01380730|147569255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.24|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-65.61|-54.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.88|-65.61|<0.001
74009219|NCT01380730|147569255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.82|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-47.18|-36.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.45|-47.18|<0.001
73991250|NCT00267098|147528784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.781||||0.9785|TWO_SIDED|95.0|0.615|0.991||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality or heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or first HF hospitalization than patients with right ventricular pacing.||0.991|0.615|0.9785
73991251|NCT00267098|147528785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695||||0.9886|TWO_SIDED|95.0|0.558|0.866||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to death or a visit in which LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or II who receive biventricular pacing have the same rate of mortality or significant increase in LVESVI as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or significant increase in LVESVI than patients with right ventricular pacing."||0.866|0.558|0.9886
73991252|NCT00267098|147528786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.9904|TWO_SIDED|95.0|0.522|0.947||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of first heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of first HF hospitalization than patients with right ventricular pacing.||0.947|0.522|0.9904
73991253|NCT00267098|147528787|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|-1.8||||0.637||||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Difference in Average Ranks|The subjects' individual rates of days hospitalized for HF were ranked, with lower ranks corresponding to fewer days hospitalized for HF.|The posterior probability that the BiV - RV difference in average ranks was below 0 (denoting that the BiV arm had lower ranks than the RV arm, on average) was calculated.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of days hospitalized for heart failure per year as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of days hospitalized for HF than patients with right ventricular pacing.||||0.637
73991254|NCT00267098|147528788|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.012||||0.591|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.591
73991255|NCT00267098|147528788|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.126||||0.986|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.986
74009220|NCT01380730|147569255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.33|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-56.04|-44.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.62|-56.04|<0.001
74035379|NCT01313520|147623465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||Constrained Longitudinal Data Analysis|||||-0.1|-0.4|<0.001
74035380|NCT01313520|147623466|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Fisher Exact|||||||0.048
74035381|NCT01313520|147623467|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Fisher Exact|||||||0.011
74035382|NCT01313520|147623468|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Constrained longitudinal data analysis|||||||<0.0001
73991256|NCT00267098|147528788|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.039||||0.726|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.726
73991257|NCT00267098|147528788|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.035||||0.701|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.701
73991258|NCT00267098|147528789|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.002||||0.534|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month change in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.534
73991259|NCT00267098|147528789|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.026||||0.825|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' change in HF stage from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.825
73991260|NCT00267098|147528789|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.01||||0.651|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 18 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote that the BiV arm had better outcomes over time than the RV arm.|Subjects' changes in HF stage from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.651
73991261|NCT00267098|147528789|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|-0.006||||0.425|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.425
73991262|NCT00267098|147528793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.9976|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 6 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 6 months than patients with right ventricular pacing."||||0.9976
74035383|NCT01313520|147623469|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||van Elteren test|||||||0.001
74035384|NCT01313520|147623470|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||van Elteren test|||||||0.0005
73876233|NCT03827655|147294296|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.453|TWO_SIDED|90.0|0.72|1.47||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.47|0.72|=0.453
73876234|NCT03827655|147294297|SUPERIORITY||Risk Difference (RD)|-0.09|||=|0.046|TWO_SIDED|90.0|-0.17|0.0||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.00|-0.17|=0.046
73876235|NCT03827655|147294297|SUPERIORITY||Risk Difference (RD)|0.0|||=|0.516|TWO_SIDED|90.0|-0.11|0.11||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.11|-0.11|=0.516
73876236|NCT03827655|147294298|SUPERIORITY||Risk Difference (RD)|-0.03|||=|0.296|TWO_SIDED|90.0|-0.12|0.06||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.06|-0.12|=0.296
73876237|NCT03827655|147294298|SUPERIORITY||Risk Difference (RD)|0.03|||=|0.677|TWO_SIDED|90.0|-0.07|0.13||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.13|-0.07|=0.677
73876238|NCT03827655|147294299|SUPERIORITY||Hazard Ratio (HR)|1.1|||=|0.338|TWO_SIDED|90.0|0.76|1.57||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.57|0.76|=0.338
73876239|NCT03827655|147294299|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.422|TWO_SIDED|90.0|0.73|1.49||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.49|0.73|=0.422
74035385|NCT01313520|147623471|SUPERIORITY_OR_OTHER||Effect Size|1.4|||||TWO_SIDED|90.0|0.92|1.87||||||||1.87|0.92|
73876240|NCT02552966|147294313|OTHER|||||||0.61|||||||t-test, 2 sided|This t-test was applied to determine if the mean salivary pepsin concentration changed between baseline and 2 week post UESAD measurements.||||||0.61
73991263|NCT00267098|147528794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.9641|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 12 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 12 months than patients with right ventricular pacing."||||0.9641
73876241|NCT02552966|147294314|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73876242|NCT02552966|147294315|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73876243|NCT02552966|147294316|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73876244|NCT00614380|147294329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34||||||95.0|0.22|0.53|||Cochran-Mantel-Haenszel|||||0.53|0.22|
73876245|NCT00614380|147294329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31||||||95.0|0.12|0.81|||Cochran-Mantel-Haenszel|||||0.81|0.12|
73876246|NCT00614380|147294329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||||95.0|0.06|0.13|||Cochran-Mantel-Haenszel|||||0.13|0.06|
73876247|NCT00614380|147294329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||||95.0|0.34|2.41|||Cochran-Mantel-Haenszel|||||2.41|0.34|
73876248|NCT00614380|147294329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25||||||95.0|0.16|0.39|||Cochran-Mantel-Haenszel|||||0.39|0.16|
73876249|NCT00614380|147294329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||||95.0|0.1|0.72|||Cochran-Mantel-Haenszel|||||0.72|0.10|
73876250|NCT03865446|147294401|OTHER||Geometric Means Ratio|130.91|||||TWO_SIDED|90.0|86.03|199.22|||||The model was an analysis of variance (ANOVA) model with unequal variance assumption and hepatic impairment group as fixed effect. Values were back-transformed from the log scale.|||199.22|86.03|
74035386|NCT01313520|147623472|SUPERIORITY_OR_OTHER||Effect Size|1.1|||||TWO_SIDED|90.0|0.64|1.55||||||||1.55|0.64|
74039706|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|3.29|||<|0.0001|TWO_SIDED|95.0|1.87|5.78|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||5.78|1.87|<.0001
73876251|NCT03865446|147294402|OTHER||Geometric Means Ratio|104.41|||||TWO_SIDED|90.0|72.12|151.16|||||The model was an ANOVA model with unequal variance assumption and hepatic impairment group as fixed effect. Values are back-transformed from the log scale.|||151.16|72.12|
73876252|NCT05274958|147294433|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Patient measures for both groups were first summarized descriptively with means and standard deviations. To compare the two groups, a t-test was used.||||<0.05
73991264|NCT00267098|147528795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.8416|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The parameter of interest was the BiV - RV difference in mean QOL change from randomization to 18 months.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 18 months than patients with right ventricular pacing."||||0.8416
73991265|NCT00267098|147528796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.727|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 24 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 24 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 24 months than patients with right ventricular pacing."||||0.7270
73991266|NCT00267098|147528797|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.334|||||TWO_SIDED|95.0|1.886|4.815||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 6 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 6 months than patients with right ventricular pacing."||4.815|1.886|
73991267|NCT00267098|147528798|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.232|||||TWO_SIDED|95.0|1.618|4.839||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 12 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 12 months than patients with right ventricular pacing.||4.839|1.618|
73991268|NCT00267098|147528799|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|2.24|||||TWO_SIDED|95.0|0.419|4.066||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF at 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 18 months than patients with right ventricular pacing.||4.066|0.419|
74009221|NCT01380730|147569255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.0|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-55.69|-44.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.31|-55.69|<0.001
74035387|NCT00789191|147623473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.001||95.0|-0.77|-0.33||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|Analysis of covariance (ANCOVA) was used; baseline HbA1c was included as covariate and treatment, stratification and country was included as factors||Null hypothesis: Difference between mean HbA1c in the two treatment arms is equal to zero. Power calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%||-0.33|-0.77|0.0010
74035388|NCT00789191|147623474|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2||||0.001||95.0|1.65|6.19||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||6.19|1.65|0.0010
74039707|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0011|TWO_SIDED|95.0|1.2|2.1|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.10|1.20|0.0011
73876253|NCT05579977|147294486|OTHER||LS Mean Difference|-0.95|||<|0.0001|TWO_SIDED|90.0|-1.2|-0.7|||Mixed Models Analysis|||||-0.70|-1.20|<.0001
73876254|NCT05579977|147294486|OTHER||LS Mean Difference|-1.3|||<|0.0001|TWO_SIDED|90.0|-1.55|-1.04|||Mixed Models Analysis|||||-1.04|-1.55|<.0001
73876255|NCT05579977|147294486|OTHER||LS Mean Difference|-1.37|||<|0.0001||90.0|-1.62|-1.11|||Mixed Models Analysis|||||-1.11|-1.62|<.0001
73991269|NCT00267098|147528800|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.623|||||TWO_SIDED|95.0|1.623|5.604||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 24 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 24 months than patients with right ventricular pacing.||5.604|1.623|
73991270|NCT00267098|147528801|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.204|||||TWO_SIDED|95.0|-10.12|-4.214||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 6 months than patients with right ventricular pacing."||-4.214|-10.12|
73991271|NCT00267098|147528802|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.255|||||TWO_SIDED|95.0|-10.59|-3.829||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 12 months than patients with right ventricular pacing.||-3.829|-10.590|
73991272|NCT00267098|147528803|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.242|||||TWO_SIDED|95.0|-11.86|-4.574||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 18 months than patients with right ventricular pacing.||-4.574|-11.860|
74035389|NCT00789191|147623475|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.008||95.0|1.26|4.81||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||4.81|1.26|0.0080
73876256|NCT05579977|147294486|OTHER||LS Mean Difference|-1.26|||<|0.0001|TWO_SIDED|90.0|-1.52|-1.01|||Mixed Models Analysis|||||-1.01|-1.52|<.0001
73876257|NCT05579977|147294486|OTHER||LS Mean Difference|-1.29|||<|0.0001||90.0|-1.55|-1.03|||Mixed Models Analysis|||||-1.03|-1.55|<.0001
74035390|NCT00789191|147623476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23||||0.063||95.0|0.96|5.2||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||5.20|0.96|0.063
74035391|NCT00789191|147623477|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07||||0.135||95.0|0.8|5.37||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic||Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate|Null hypothesis: Odds ratio is equal to one.||5.37|0.8|0.135
73876258|NCT05579977|147294486|OTHER||LS Mean Difference|-0.86|||<|0.0001|TWO_SIDED|90.0|-1.12|-0.61|||Mixed Models Analysis|||||-0.61|-1.12|<.0001
73876259|NCT05579977|147294487|OTHER||LS Mean Difference|-2.44||||0.0055|TWO_SIDED|90.0|-3.88|-1.0|||Mixed Models Analysis|||||-1.00|-3.88|0.0055
73876260|NCT05579977|147294487|OTHER||LS Mean Difference|-4.37|||<|0.0001|TWO_SIDED|90.0|-5.84|-2.89|||Mixed Models Analysis|||||-2.89|-5.84|<.0001
73876261|NCT05579977|147294487|OTHER||LS Mean Difference|-5.63|||<|0.0001|TWO_SIDED|90.0|-7.07|-4.18|||Mixed Models Analysis|||||-4.18|-7.07|<.0001
73876262|NCT05579977|147294487|OTHER||LS Mean Difference|-5.04|||<|0.0001|TWO_SIDED|90.0|-6.5|-3.58|||Mixed Models Analysis|||||-3.58|-6.50|<.0001
73876263|NCT05579977|147294487|OTHER||LS Mean Difference|-5.42|||<|0.0001|TWO_SIDED|90.0|-6.91|-3.93|||Mixed Models Analysis|||||-3.93|-6.91|<.0001
73991273|NCT00267098|147528804|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.268|||||TWO_SIDED|95.0|-11.69|-2.846||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 24 months than patients with right ventricular pacing.||-2.846|-11.690|
73991274|NCT00267098|147528805|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-5.858|||||TWO_SIDED|95.0|-9.085|-2.562||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 6 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 6 months than patients with right ventricular pacing.||-2.562|-9.085|
73991275|NCT00267098|147528806|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-5.807|||||TWO_SIDED|95.0|-9.467|-2.038||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 12 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 12 months than patients with right ventricular pacing."||-2.038|-9.467|
73991276|NCT00267098|147528807|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.844|||||TWO_SIDED|95.0|-12.91|-4.681||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 18 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 18 months than patients with right ventricular pacing."||-4.681|-12.910|
73991277|NCT00267098|147528808|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-6.615|||||TWO_SIDED|95.0|-11.37|-1.736||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 24 months than patients with right ventricular pacing.||-1.736|-11.370|
73991278|NCT00267098|147528809|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-3.894|||||TWO_SIDED|95.0|-12.13|3.953||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||3.953|-12.130|
74089962|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|1.37||||0.03|TWO_SIDED|95.0|0.16|2.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Stretching.||2.57|0.16|0.03
74089963|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|2.07||||0|TWO_SIDED|95.0|0.98|3.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Stretching.||3.16|0.98|0.00
73991279|NCT00267098|147528810|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-10.16|||||TWO_SIDED|95.0|-19.33|-0.857||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||-0.857|-19.330|
73991280|NCT00267098|147528811|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.316|||||TWO_SIDED|95.0|-18.19|1.623||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||1.623|-18.190|
73991281|NCT00267098|147528812|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-11.08|||||TWO_SIDED|95.0|-21.11|-0.956||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||-0.956|-21.110|
73991282|NCT00267098|147528813|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.126|||||TWO_SIDED|95.0|-0.235|-0.014||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.014|-0.235|
73991283|NCT00267098|147528814|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.162|||||TWO_SIDED|95.0|-0.287|-0.035||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.035|-0.287|
74009222|NCT01380730|147569255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.84|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-47.55|-36.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.13|-47.55|<0.001
74089964|NCT02312713|147732648|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.48||||0.33|TWO_SIDED|95.0|-1.46|0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Stretching.||0.5|-1.46|0.33
74009223|NCT01380730|147569256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.2|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-87.0|-71.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-71.5|-87.0|<0.001
74089965|NCT02312713|147732648|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.45||||0.32|TWO_SIDED|95.0|-0.44|1.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Stretching.||1.34|-0.44|0.32
74035392|NCT00789191|147623478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.121||95.0|-0.07|0.63||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||0.63|-0.07|0.121
74035393|NCT00789191|147623479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84||||0.109||95.0|-0.19|1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||1.88|-0.19|0.109
74035394|NCT00789191|147623480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.45||||0.001||95.0|-3.01|-1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||-1.88|-3.01|0.0010
73876264|NCT05579977|147294490|OTHER||LS Mean Difference|-0.86|||<|0.0001|TWO_SIDED|90.0|-1.12|-0.61|||Mixed Models Analysis|||||-0.61|-1.12|<.0001
74035395|NCT00789191|147623484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01||||||95.0|-2.5|-1.51|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before breakfast|||-1.51|-2.50|
74035396|NCT00789191|147623484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||||95.0|-2.4|-0.89|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of breakfast|||-0.89|-2.40|
74035397|NCT00789191|147623484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||||95.0|-1.69|-0.35|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before lunch|||-0.35|-1.69|
74035398|NCT00789191|147623484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||||95.0|-2.05|-0.56|||Linear mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of lunch|||-0.56|-2.05|
74035399|NCT00789191|147623484|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.77||||||95.0|-1.58|0.05|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before dinner|||0.05|-1.58|
74035400|NCT00789191|147623484|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.88||||||95.0|-1.75|-0.02|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of dinner|||-0.02|-1.75|
74035401|NCT00789191|147623484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||||95.0|-1.88|-0.2|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Bedtime|||-0.20|-1.88|
74035402|NCT00789191|147623484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||||95.0|-1.84|-0.49|||Linear Mixed Model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. At 03:00 a.m.|||-0.49|-1.84|
74035403|NCT00789191|147623484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||||95.0|-2.26|-1.34|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before breakfast the following day|||-1.34|-2.26|
74035404|NCT00442013|147623571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.086||0.12|TWO_SIDED|95.0|0.0|0.3|||Regression, Linear|Linear mixed effects model is robust to data that are missing at random that has characteristics similar to multiple imputation techniques.||All participants included in the analysis. The model includes the data (ACQ scores) from all time points including baseline. The treatment effect (delta-delta) comparing the difference from baseline at 6 months is estimated from the model. Longitudinal models estimated the change from baseline to 6 months in a measurement using generalized estimating equations with an unstructured or exchangeable covariance matrix to adjust for repeated measures.||0.3|0.0|0.12
74035405|NCT00442013|147623572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2593||0.65|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.65
73876265|NCT03628976|147294501|SUPERIORITY|||||||0.0096|||||||ANOVA|||||||0.0096
73876266|NCT03628976|147294502|SUPERIORITY|||||||0.764|||||||ANOVA|||||||0.764
73876267|NCT03628976|147294503|SUPERIORITY|||||||0.446|||||||ANOVA|||||||0.446
73876268|NCT01420926|147294504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Stratified 1-sided log-rank|||||||0.30
74035406|NCT00442013|147623573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0906||0.99|TWO_SIDED|95.0|-0.1|0.1|||Regression, Linear|||||0.1|-0.1|0.99
74035407|NCT00442013|147623574|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.3|TWO_SIDED|95.0|0.9|1.7|||negative binomial|||||1.7|0.9|0.30
74035408|NCT00442013|147623575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.14|TWO_SIDED|95.0|-0.07|0.01|||Regression, Linear|Model includes the data from all time points. Treatment effect (delta-delta) comparing the difference from baseline at 24 weeks is from the model.||||0.01|-0.07|0.14
73991284|NCT00267098|147528815|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.163|||||TWO_SIDED|95.0|-0.293|-0.03||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.030|-0.293|
73991285|NCT00267098|147528816|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.245|||||TWO_SIDED|95.0|-0.39|-0.097||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.097|-0.390|
73991286|NCT00267098|147528817|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.066|||||TWO_SIDED|95.0|-0.185|0.055||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.055|-0.185|
73991287|NCT00267098|147528818|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.104|||||TWO_SIDED|95.0|-0.236|0.029||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.029|-0.236|
73991288|NCT00267098|147528819|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.204|0.087||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.087|-0.204|
73991289|NCT00267098|147528820|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.18|||||TWO_SIDED|95.0|-0.339|-0.018||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVESD.||-0.018|-0.339|
73876269|NCT04564846|147294509|OTHER||Risk Ratio (RR)|0.974||||0.1628|TWO_SIDED|95.0|0.938|1.011|||Analysis of Covariance||Estimated Difference from Placebo Across All Time Points. Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|Comparison to Placebo Across All Time Points||1.011|0.938|0.1628
73991290|NCT00267098|147528821|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.683|||||TWO_SIDED|95.0|-2.828|1.506||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||1.506|-2.828|
73991291|NCT00267098|147528822|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.564|||||TWO_SIDED|95.0|-2.843|1.773||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||1.773|-2.843|
73991292|NCT00267098|147528823|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.016|||||TWO_SIDED|95.0|-2.379|2.425||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||2.425|-2.379|
73991293|NCT00267098|147528824|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.653|||||TWO_SIDED|95.0|-3.337|2.046||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||2.046|-3.337|
73991294|NCT00267098|147528825|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.08|||||TWO_SIDED|95.0|-0.031|0.195||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||0.195|-0.031|
73991295|NCT00267098|147528826|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.086|||||TWO_SIDED|95.0|-0.022|0.198||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||0.198|-0.022|
74009224|NCT01380730|147569256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.4|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-85.2|-69.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-69.6|-85.2|<0.001
74009225|NCT01380730|147569256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.7|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-58.5|-43.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.0|-58.5|<0.001
73876270|NCT04564846|147294511|OTHER||Risk Ratio (RR)|0.784||||0.0674|TWO_SIDED|95.0|0.605|1.017|||Analysis of Covariance|||Estimated Difference from Placebo Across All Time Points|Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|1.017|0.605|0.0674
73876271|NCT04564846|147294512|OTHER|Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|Risk Ratio, log|1.067||||0.8182|TWO_SIDED|95.0|0.976|1.167|||Analysis of Covariance|||Estimated Difference from Placebo Across All Time Points.||1.167|0.976|0.8182
73876272|NCT04564846|147294513|OTHER|AUC Parameters analyzed using an Analysis of Covariance model with treatment as the main effect and baseline HbA1c as a covariate.|Risk Ratio, log|1.007||||0.8182|TWO_SIDED|95.0|0.951|1.066|||Analysis of Covariance|||||1.066|0.951|0.8182
73876273|NCT04564846|147294514|OTHER||Analysis of Variance|0.4628|||||TWO_SIDED|||||Parameter analyzed using an Analysis of Variance model with treatment as the main effect.||||||||
73876274|NCT00865345|147294515|SUPERIORITY_OR_OTHER||Intercept from ANCOVA model|70.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.05|TWO_SIDED|95.0|60.0|100.0|||ANCOVA|null model ANOVA is used to calculate 95% CI around accuracy rate. Intercept was fit in the abscence of other predictors.||||100|60|<0.05
73991296|NCT00267098|147528827|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.081|||||TWO_SIDED|95.0|-0.218|0.058||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||0.058|-0.218|
73991297|NCT00267098|147528828|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.047|||||TWO_SIDED|95.0|-0.095|0.192||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||0.192|-0.095|
73991298|NCT00267098|147528829|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|29.3|||||TWO_SIDED|95.0|10.04|48.64||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value. A positive value reflected reduction in IVMD.||48.640|10.040|
74009226|NCT01380730|147569256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.1|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-68.6|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-53.7|-68.6|<0.001
73876275|NCT00387881|147294530|SUPERIORITY_OR_OTHER||Percent difference|18.0|||<|0.001||95.0|10.0|25.0||Endpoints were co-primary and both needed to have p-value of \<0.05 to be considered indicative of efficacy.|Cochran-Mantel-Haenszel||Analysis for Migraine Pain-Free at 2 hours Post-Dose|Pain-Free (2 hours)||25|10|<0.001
73876276|NCT00387881|147294530|SUPERIORITY_OR_OTHER||Percent difference|15.0|||<|0.001||95.0|8.0|22.0|||Cochran-Mantel-Haenszel||Analysis for Sustained Pain Free from 2-24 hours Post-dose|Sustained Pain-Free (2-24 hours)||22|8|<0.001
73876277|NCT01790594|147294541|SUPERIORITY||Mean Difference (Final Values)|2.088||||0.75|TWO_SIDED|95.0|-11.067|15.242|||Mixed Models Analysis|||The p-value compares Investigational arm and control arm.||15.242|-11.067|0.750
73876278|NCT00496015|147294583|SUPERIORITY|Superiority criteria: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) for the difference between groups (Synflorix PRE Group minus Synflorix I Group) was above 0%.|Difference in percentages|22.18|||||TWO_SIDED|95.0|11.78|32.11||||||||32.11|11.78|
73876279|NCT00527735|147294616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.806||||0.1302|TWO_SIDED|95.0|0.553|1.174|||1-sided log rank|||||1.174|0.553|0.1302
73876280|NCT00527735|147294616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.724||||0.0473|TWO_SIDED|95.0|0.495|1.059|||1-sided log rank|||||1.059|0.495|0.0473
73876281|NCT00527735|147294617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.2502|TWO_SIDED|95.0|0.612|1.271|||One-sided log rank|||||1.271|0.612|0.2502
73876282|NCT00527735|147294617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||0.024|TWO_SIDED|95.0|0.478|0.999|||One-sided log rank|||||0.999|0.478|0.0240
73876283|NCT00527735|147294618|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.4759|TWO_SIDED|95.0|0.669|1.46|||1-sided log rank|||||1.460|0.669|0.4759
73876284|NCT00527735|147294618|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.866||||0.234|TWO_SIDED|95.0|0.587|1.278|||1-sided log rank|||||1.278|0.587|0.2340
73876285|NCT00527735|147294625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.1098|TWO_SIDED|95.0|0.475|1.188|||1-sided log rank|||||1.188|0.475|0.1098
73876286|NCT00527735|147294625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0282|TWO_SIDED|95.0|0.403|1.1016|||1-sided log rank|||||1.1016|0.403|0.0282
73991299|NCT00267098|147528830|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|21.83|||||TWO_SIDED|95.0|2.841|40.87||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value. A positive value reflected reduction in IVMD.||40.870|2.841|
73991300|NCT00267098|147528831|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|26.53|||||TWO_SIDED|95.0|6.247|47.19||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value. A positive value reflected reduction in IVMD.||47.190|6.247|
73991301|NCT00267098|147528832|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|23.32|||||TWO_SIDED|95.0|1.999|44.53||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value. A positive value reflected reduction in IVMD.||44.530|1.999|
73991302|NCT00267098|147528833|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.047|||||TWO_SIDED|95.0|-0.18|0.089||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||0.089|-0.180|
73991303|NCT00267098|147528834|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.117|||||TWO_SIDED|95.0|-0.287|0.058||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||0.058|-0.287|
73991304|NCT00267098|147528835|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.041|||||TWO_SIDED|95.0|-0.136|0.22||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||0.220|-0.136|
73991305|NCT00267098|147528836|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.11|||||TWO_SIDED|95.0|-0.085|0.311||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||0.311|-0.085|
73876287|NCT00527735|147294634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.3846|TWO_SIDED|95.0|0.588|1.481|||1-sided Log Rank|||||1.481|0.588|0.3846
73876288|NCT00527735|147294634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.37|TWO_SIDED|95.0|0.591|1.453|||1-sided Log Rank|||||1.453|0.591|0.3700
73876289|NCT00527735|147294637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947||||0.4132|TWO_SIDED|95.0|0.585|1.536|||1-sided Log Rank|||||1.536|0.585|0.4132
73876290|NCT00527735|147294637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.753||||0.1287|TWO_SIDED|95.0|0.461|1.232|||1-sided Log Rank|||||1.232|0.461|0.1287
73991306|NCT00267098|147528837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1841||||0.9985||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9985
73991307|NCT00267098|147528838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2503||||0.9999||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9999
73991308|NCT00267098|147528839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1978||||0.9978||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9978
73991309|NCT00267098|147528840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2069||||0.9983||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9983
74035409|NCT00442013|147623576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.2|TWO_SIDED|95.0|-2.1|0.4|||Regression, Linear|||||0.4|-2.1|0.20
73876291|NCT02271698|147294676|SUPERIORITY_OR_OTHER|||||||0.052||||||6 hour pain at rest|t-test, 2 sided|||||||0.052
73876292|NCT02271698|147294676|SUPERIORITY_OR_OTHER|||||||0.064||||||6 hour pain with movement|t-test, 2 sided|||||||0.064
73876293|NCT02271698|147294676|SUPERIORITY_OR_OTHER|||||||0.139|||||||t-test, 2 sided|12 hour pain at rest||||||0.139
73876294|NCT02271698|147294676|SUPERIORITY_OR_OTHER|||||||0.35||||||12 hour pain at rest|t-test, 2 sided|||||||0.350
73876295|NCT02271698|147294676|SUPERIORITY_OR_OTHER|||||||0.021||||||18 hour pain at rest|t-test, 2 sided|||||||0.021
73876296|NCT02271698|147294676|SUPERIORITY_OR_OTHER|||||||0.198||||||18 hour pain with movement|t-test, 2 sided|||||||0.198
73876297|NCT02271698|147294676|SUPERIORITY_OR_OTHER|||||||0.806|||||||t-test, 2 sided|24 hour pain at rest||||||0.806
73876298|NCT02271698|147294676|SUPERIORITY_OR_OTHER|||||||0.228||||||24 hour pain with movement|t-test, 2 sided|||||||0.228
73876299|NCT02271698|147294676|SUPERIORITY_OR_OTHER|||||||0.457||||||36 hour pain at rest|t-test, 2 sided|||||||0.457
73876300|NCT02271698|147294676|SUPERIORITY_OR_OTHER|||||||0.394||||||36 hour pain with movement|t-test, 2 sided|||||||0.394
73876301|NCT02271698|147294677|SUPERIORITY_OR_OTHER|||||||0.181||||||6 hours|t-test, 2 sided|||||||0.181
73876302|NCT02271698|147294677|SUPERIORITY_OR_OTHER|||||||0.364||||||12 hours|t-test, 2 sided|||||||0.364
73876303|NCT02271698|147294677|SUPERIORITY_OR_OTHER|||||||0.605|||||||t-test, 2 sided|18 hours||||||0.605
73876304|NCT02271698|147294677|SUPERIORITY_OR_OTHER|||||||0.733|||||||t-test, 2 sided|24 hours||||||0.733
73876305|NCT02271698|147294677|SUPERIORITY_OR_OTHER|||||||0.6||||||36 hours|t-test, 2 sided|||||||0.600
73876306|NCT01755234|147294687|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.97
73876307|NCT01755234|147294688|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.96
73876308|NCT01755234|147294689|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.96
73876309|NCT01755234|147294690|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.84
73876310|NCT03001557|147294695|SUPERIORITY||Least square mean (LSM) difference|3.177||||0.1099|TWO_SIDED|95.0|-0.741|7.096||Based on a mixed model for repeated measure (MMRM) analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.096|-0.741|0.1099
73991310|NCT00267098|147528842|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.189|TWO_SIDED|95.0|0.78|2.01||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to first ventricular arrhythmia occurring post-randomization for each subject. Ventricular arrhythmias occurring prior to randomization were excluded. A 95% credible interval was used.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, NYHA classifications of I-III, and indicated for defibrillation therapy who receive biventricular (BiV) pacing have the same rate of experiencing their first ventricular arrhythmia as corresponding patients who receive right ventricular pacing. This was tested against the one-side hypothesis that patients with BiV pacing have a lower risk of ventricular arrhythmias than subjects with right ventricular pacing.||2.01|0.78|0.189
73991311|NCT02104505|147528989|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.18||0.04|TWO_SIDED||||||Mixed Models Analysis||Comparison of change in sputum %PMNs during active treatment vs placebo (crossover design).|||||0.04
73991312|NCT02104505|147528990|SUPERIORITY||Mean Difference (Net)|0.64|STANDARD_ERROR_OF_MEAN|0.22||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
73991313|NCT02104505|147528991|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.33||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.6
73991314|NCT02104505|147528992|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.33||0.34|TWO_SIDED||||||Mixed Models Analysis|||||||0.34
73991315|NCT02366143|147529006|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.74|||Log Rank|||ITT-WT population||0.74|0.52|<0.0001
73991316|NCT02366143|147529006|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.68|||Log Rank|||Teff-high WT Population||0.68|0.38|<0.0001
73991317|NCT02366143|147529007|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.78||||0.0164|TWO_SIDED|95.0|0.64|0.96|||Log Rank|||||0.96|0.64|0.0164
73876311|NCT03001557|147294695|SUPERIORITY||LSM Difference|2.802||||0.1576|TWO_SIDED|95.0|-1.119|6.723||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.723|-1.119|0.1576
73991318|NCT02366143|147529008|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.842||||0.0528|TWO_SIDED|95.0|0.707|1.002|||Log Rank|||||1.002|0.707|0.0528
73991319|NCT02366143|147529009|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Log Rank|||ITT-WT population||0.85|0.59|0.0002
73991320|NCT02366143|147529009|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.564||||0.0001|TWO_SIDED|95.0|0.418|0.76|||Log Rank|||Teff-high WT Population||0.760|0.418|0.0001
73991321|NCT02366143|147529010|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.492|||<|0.0001|TWO_SIDED|95.0|0.374|0.649|||Log Rank|||Teff-high Population||0.649|0.374|<.0001
73991322|NCT02366143|147529010|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.517|0.72|||Log Rank|||ITT Population||0.720|0.517|<.0001
73991323|NCT02366143|147529012|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.471|||<|0.0001|TWO_SIDED|95.0|0.352|0.647|||Log Rank|||TC2/3 or IC2/3 Subgroup||0.647|0.352|<.0001
73991324|NCT02366143|147529012|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.486|||<|0.0001|TWO_SIDED|95.0|0.386|0.639|||Log Rank|||TC1/2/3 or IC1/2/3 Subgroup||0.639|0.386|<.0001
73991325|NCT02366143|147529013|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.824||||0.2765|TWO_SIDED|95.0|0.58|1.169|||Log Rank|||TC2/3 or IC2/3, WT ITT||1.169|0.580|0.2765
73876312|NCT03001557|147294695|SUPERIORITY||LSM Difference|-0.96||||0.616|TWO_SIDED|95.0|-4.777|2.857||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.857|-4.777|0.6160
73876313|NCT03001557|147294695|SUPERIORITY||LSM Difference|0.713||||0.7135|TWO_SIDED|95.0|-3.16|4.585||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||4.585|-3.160|0.7135
73876314|NCT03001557|147294699|SUPERIORITY||LSM Difference|-5.098||||0.1582|TWO_SIDED|95.0|-12.24|2.045||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.045|-12.240|0.1582
73991326|NCT02366143|147529013|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.771||||0.0829|TWO_SIDED|95.0|0.575|1.035|||Log Rank|||TC1/2/3 or IC1/2/3, WT ITT||1.035|0.575|0.0829
73991327|NCT02366143|147529014|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.709||||0.0073|TWO_SIDED|95.0|0.551|0.913|||Log Rank|||TC1/2/3 or IC1/2/3 ITT-WT||0.913|0.551|0.0073
73991328|NCT02366143|147529014|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.662||||0.0097|TWO_SIDED|95.0|0.484|0.907|||Log Rank|||TC2/3 or IC2/3 Population||0.907|0.484|0.0097
73991329|NCT02366143|147529015|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.831||||0.2843|TWO_SIDED|95.0|0.592|1.167|||Log Rank|||Teff high-WT||1.167|0.592|0.2843
73991330|NCT02366143|147529015|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.802||||0.1861|TWO_SIDED|95.0|0.579|1.113|||Log Rank|||Teff high||1.113|0.579|0.1861
73991331|NCT02366143|147529015|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.764||||0.006|TWO_SIDED|95.0|0.63|0.926|||Log Rank|||ITT||0.926|0.630|0.0060
73991332|NCT02366143|147529016|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.786||||0.0894|TWO_SIDED|95.0|0.595|1.038|||Log Rank|||Teff high-WT||1.038|0.595|0.0894
73991333|NCT02366143|147529016|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.815||||0.1276|TWO_SIDED|95.0|0.626|1.061|||Log Rank|||Teff high||1.061|0.626|0.1276
73991334|NCT02366143|147529016|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.861||||0.0681|TWO_SIDED|95.0|0.733|1.011|||Log Rank|||ITT||1.011|0.733|0.0681
73991335|NCT02366143|147529017|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.901||||0.4599|TWO_SIDED|95.0|0.683|1.188|||Log Rank|||Teff high-WT ITT||1.188|0.683|0.4599
73991336|NCT02366143|147529018|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.523|||<|0.0001|TWO_SIDED|95.0|0.406|0.675|||Log Rank|||ITT-WT||0.675|0.406|<.0001
73991337|NCT02366143|147529018|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.283|0.624|||Log Rank|||Teff-high WT||0.624|0.283|<.0001
74089966|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.21|TWO_SIDED|95.0|-0.61|2.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Aerobic Exercise.||2.8|-0.61|0.21
73991338|NCT02366143|147529020|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|6.68||||0.0697|TWO_SIDED|95.0|-0.54|13.9|||Z-test|||1-Year ITT-WT Population||13.90|-0.54|0.0697
73991339|NCT02366143|147529020|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.71||||0.0347|TWO_SIDED|95.0|0.7|18.73|||Z-test|||2-Year ITT-WT Population||18.73|0.70|0.0347
73991340|NCT02366143|147529020|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.89||||0.089|TWO_SIDED|95.0|-1.51|21.29|||Z-test|||1-Year Teff-high WT Population||21.29|-1.51|0.0890
73991341|NCT02366143|147529020|OTHER|Stratified Analysis|Difference in Event Free Rate|10.34||||0.1336|TWO_SIDED|95.0|-3.17|23.84|||Z-test|||2-Year Teff-high WT Population||23.84|-3.17|0.1336
73991342|NCT02366143|147529021|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|4.18||||0.2624|TWO_SIDED|95.0|-3.13|11.48|||Z-test|||1-Year ITT-WT Population||11.48|-3.13|0.2624
73991343|NCT02366143|147529021|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.67||||0.0088|TWO_SIDED|95.0|2.43|16.9|||Z-test|||2-Year ITT-WT Population||16.90|2.43|0.0088
73991344|NCT02366143|147529021|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|10.56||||0.0649|TWO_SIDED|95.0|-0.65|21.77|||Z-test|||1-Year Teff-high WT Population||21.77|-0.65|0.0649
73991345|NCT02366143|147529021|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|7.27||||0.212|TWO_SIDED|95.0|-4.15|18.69|||Z-test|||2-Year Teff-high WT Population||18.69|-4.15|0.2120
73991346|NCT02366143|147529022|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.909||||0.6899|TWO_SIDED|95.0|0.571|1.45|||Log Rank|||Teff-high WT Population||1.450|0.571|0.6899
74089967|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|2.07||||0.04|TWO_SIDED|95.0|0.13|4.0|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Aerobic Exercise.||4|0.13|0.04
73991347|NCT02366143|147529022|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.671||||0.1043|TWO_SIDED|95.0|0.413|1.089|||Log Rank|||Teff-high WT Population||1.089|0.413|0.1043
73991348|NCT02366143|147529022|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.232||||0.173||95.0|0.912|1.665|||Log Rank|||ITT WT||1.665|0.912|0.1730
73991349|NCT02366143|147529022|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.084||||0.6145|TWO_SIDED|95.0|0.792|1.483|||Log Rank|||ITT WT||1.483|0.792|0.6145
73991350|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.041||||0.8816|TWO_SIDED|95.0|0.614|1.763|||Log Rank|||Cough for Teff-high WT ITT population||1.763|0.614|0.8816
73991351|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.741||||0.2995|TWO_SIDED|95.0|0.419|1.309|||Log Rank|||Cough for Teff-high WT ITT Population||1.309|0.419|0.2995
73991352|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.936||||0.7578|TWO_SIDED|95.0|0.616|1.422|||Log Rank|||Dyspnea in Teff-high WT Population||1.422|0.616|0.7578
74089968|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.03|TWO_SIDED|95.0|0.15|3.62|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Aerobic Exercise.||3.62|0.15|0.03
74089969|NCT02312713|147732648|SUPERIORITY||Mean Difference (Final Values)|1.99||||0.05|TWO_SIDED|95.0|0.01|3.97|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Aerobic Exercise.||3.97|0.01|0.05
73991353|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.041||||0.847|TWO_SIDED|95.0|0.694|1.56|||Log Rank|||Dyspnea in Teff-high WT Population||1.560|0.694|0.8470
73991354|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.659||||0.1289|TWO_SIDED|95.0|0.383|1.133|||Log Rank|||Pain in Chest in Teff-high WT Population||1.133|0.383|0.1289
73991355|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.729||||0.2381|TWO_SIDED|95.0|0.43|1.235|||Log Rank|||Pain in Chest in Teff-high WT Population||1.235|0.430|0.2381
73991356|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.09||||0.7163|TWO_SIDED|95.0|0.685|1.732|||Log Rank|||Arm and/or Shoulder Pain in Teff-high WT||1.732|0.685|0.7163
73991357|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.693||||0.1502|TWO_SIDED|95.0|0.42|1.145|||Log Rank|||Arm and/or Shoulder Pain in Teff-high WT||1.145|0.420|0.1502
73991358|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.01||||0.9568|TWO_SIDED|95.0|0.713|1.43|||Log Rank|||Cough in ITT-WT Population||1.430|0.713|0.9568
73991359|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.891||||0.5377|TWO_SIDED|95.0|0.619|1.284|||Log Rank|||Cough in ITT-WT Population||1.284|0.619|0.5377
73991360|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.893||||0.4012|TWO_SIDED|95.0|0.685|1.163|||Log Rank|||Dyspnea in ITT-WT Population||1.163|0.685|0.4012
73991361|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.05||||0.7149|TWO_SIDED|95.0|0.809|1.363|||Log Rank|||Dyspnea in ITT-WT Population||1.363|0.809|0.7149
73991362|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.057||||0.7126|TWO_SIDED|95.0|0.786|1.422|||Log Rank|||Arm and/or Shoulder Pain in ITT-WT||1.422|0.786|0.7126
73991363|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.921||||0.6053|TWO_SIDED|95.0|0.675|1.258|||Log Rank|||Arm and/or Shoulder Pain in ITT-WT||1.258|0.675|0.6053
73991364|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.829||||0.3134|TWO_SIDED|95.0|0.576|1.194|||Log Rank|||Pain in Chest in ITT-WT Population||1.194|0.576|0.3134
73991365|NCT02366143|147529023|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.91||||0.6115|TWO_SIDED|95.0|0.633|1.309|||Log Rank|||Pain in Chest in ITT-WT Population||1.309|0.633|0.6115
73991366|NCT01385748|147529040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.165|TWO_SIDED|95.0|0.387|1.186|||Log Rank|The log rank test at 5% significance level was used.||||1.186|0.387|0.165
73991367|NCT01385748|147529040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.817||||0.421|TWO_SIDED|95.0|0.495|1.35|||Log Rank|The log rank test at 5% significance level was used.||||1.35|0.495|0.421
73876315|NCT03001557|147294699|SUPERIORITY||LSM Difference|-6.105||||0.0961|TWO_SIDED|95.0|-13.332|1.122||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.122|-13.332|0.0961
73991368|NCT01385748|147529040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.754||||0.211|TWO_SIDED|95.0|0.484|1.175|||Log Rank|The log rank test at 5% significance level was used.||||1.175|0.484|0.211
73991369|NCT01385748|147529043|SUPERIORITY_OR_OTHER|||||||0.807||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)|||||||0.807
73991370|NCT01385748|147529043|SUPERIORITY_OR_OTHER|||||||0.971||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)|||||||0.971
73991371|NCT01385748|147529045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.698||||0.199|TWO_SIDED|95.0|0.398|1.223||Significance threshold = 5%|Log Rank|||||1.223|0.398|0.199
73991372|NCT01385748|147529045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.817||||0.424|TWO_SIDED|95.0|0.493|1.353|||Log Rank|Significance threshold = 5%||||1.353|0.493|0.424
73991373|NCT01385748|147529045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.235|TWO_SIDED|95.0|0.489|1.193|||Log Rank|Significance threshold = 5%||||1.193|0.489|0.235
73991374|NCT01385748|147529046|SUPERIORITY_OR_OTHER|||||||0.176|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.176
73991375|NCT01385748|147529046|SUPERIORITY_OR_OTHER|||||||0.61|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.61
73991376|NCT01385748|147529046|SUPERIORITY_OR_OTHER|||||||0.295|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.295
73991377|NCT01385748|147529047|SUPERIORITY_OR_OTHER|||||||0.063||||||Significance threshold = 5%|Chi-squared|||||||0.063
73991378|NCT01385748|147529047|SUPERIORITY_OR_OTHER|||||||0.169|||||||Chi-squared|||||||0.169
73991379|NCT01385748|147529047|SUPERIORITY_OR_OTHER|||||||0.064|||||||Chi-squared|Significance threshold = 5%||||||0.064
73876316|NCT03001557|147294699|SUPERIORITY||LSM Difference|0.68||||0.8449|TWO_SIDED|95.0|-6.262|7.623||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.623|-6.262|0.8449
73991380|NCT01385748|147529048|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.824||||0.388|TWO_SIDED|95.0|0.484|1.401|||Log Rank|Significance threshold = 5%||||1.401|0.484|0.388
73991381|NCT01385748|147529048|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601||||0.054|TWO_SIDED|95.0|0.357|1.012|||Log Rank|Significance threshold = 5%||||1.012|0.357|0.054
73991382|NCT01385748|147529048|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.102|TWO_SIDED|95.0|0.444|1.078|||Log Rank|Significance threshold = 5%||||1.078|0.444|0.102
73991383|NCT00656201|147529050|NON_INFERIORITY_OR_EQUIVALENCE|This was an equivalence comparison. The study was designed to detect a 14% pregnancy difference between the arms with 80% power and one interim analysis using O'Brien-Fleming parameters and an experiment-wise alpha level of 5%.|Odds Ratio (OR)|1.2|||<|0.05|TWO_SIDED|95.0|0.8|1.8|||Wilcoxon (Mann-Whitney)||Crinone is the numerator and IM Progesterone is the denominator.|||1.8|0.8|<0.05
73991384|NCT02007200|147529051|SUPERIORITY_OR_OTHER||||||<|0.005|||||||Linear Repeated Measures Model|||||||<0.005
73991385|NCT03865953|147529078|SUPERIORITY|Analysis used a two-period two-treatment crossover design|Mean Difference (Net)|-0.14||||0.67|TWO_SIDED|95.0|-0.76|0.49|||Mixed Models Analysis|||Subject numbers gave a 90% power to demonstrate a statistically significant difference in the mean change from baseline NPRS for the active treatment compared with placebo of at least 1 unit, with a two sided test at a 5% level of significance||0.49|-0.76|0.67
73991386|NCT01271504|147529111|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.56|1.5||||||||1.50|0.56|
73991387|NCT01271504|147529112|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.57|1.5||||||||1.50|0.57|
73991388|NCT01271504|147529114|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.6|1.62||||||||1.62|0.60|
73991389|NCT02229578|147529116|SUPERIORITY||Mean Difference (Final Values)|0.45|||<|0.05|TWO_SIDED|95.0|-1.2|2.1|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.||2.1|-1.2|<0.05
73876317|NCT03001557|147294699|SUPERIORITY||LSM Difference|-3.14||||0.3747|TWO_SIDED|95.0|-10.178|3.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||3.897|-10.178|0.3747
73876318|NCT03001557|147294703|SUPERIORITY||LSM Difference|1.932||||0.3966|TWO_SIDED|95.0|-2.601|6.465||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.465|-2.601|0.3966
73991390|NCT02229578|147529117|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.79|<|0.05|TWO_SIDED|95.0|-1.77|1.49|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.||1.49|-1.77|<0.05
73991391|NCT02229578|147529118|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|3.61|<|0.05|TWO_SIDED|95.0|-9.62|6.09|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop hydromorphone on 24 hour hydromorphone. This allows patient to serve as own control for intial values.||6.09|-9.62|<0.05
73991392|NCT02706951|147529123|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|26.5|||<|0.001|TWO_SIDED|95.0|17.5|35.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||35.6|17.5|<0.001
73991393|NCT02706951|147529123|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|30.0|||<|0.001|TWO_SIDED|95.0|21.0|38.9||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||38.9|21.0|<0.001
74009227|NCT01380730|147569256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.1|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-68.5|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-53.7|-68.5|<0.001
74089970|NCT02312713|147732648|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.27|TWO_SIDED|95.0|-0.62|2.2|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Aerobic Exercise.||2.2|-0.62|0.27
73991394|NCT02706951|147529124|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|25.3|||<|0.001|TWO_SIDED|95.0|16.8|33.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||33.7|16.8|<0.001
73991395|NCT02706951|147529124|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|33.6|||<|0.001|TWO_SIDED|95.0|25.1|42.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||42.1|25.1|<0.001
73991396|NCT02706951|147529125|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Least Squares (LS) Mean Difference|-1.08|||<|0.001|TWO_SIDED|95.0|-1.32|-0.85||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment as the fixed factor, and baseline value and geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.85|-1.32|<0.001
73991397|NCT02706951|147529125|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.64|-1.17||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-1.17|-1.64|<0.001
73991398|NCT02706951|147529126|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.43|-0.22||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.22|-0.43|<0.001
73991399|NCT02706951|147529126|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.51|-0.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.30|-0.51|<0.001
73991400|NCT02706951|147529127|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|3.97|||<|0.001|TWO_SIDED|95.0|2.52|5.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||5.42|2.52|<0.001
73991401|NCT02706951|147529127|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|5.87|||<|0.001|TWO_SIDED|95.0|4.42|7.32||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||7.32|4.42|<0.001
73991402|NCT02706951|147529128|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|12.8|26.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||26.8|12.8|<0.001
74089971|NCT02312713|147732648|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.07||||0.93|TWO_SIDED|95.0|-1.69|1.54|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Aerobic Exercise.||1.54|-1.69|0.93
73876319|NCT03001557|147294703|SUPERIORITY||LSM Difference|3.386||||0.1381|TWO_SIDED|95.0|-1.125|7.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.897|-1.125|0.1381
73876320|NCT03001557|147294703|SUPERIORITY||LSM Difference|1.337||||0.5487|TWO_SIDED|95.0|-3.104|5.778||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||5.778|-3.104|0.5487
73876321|NCT03001557|147294703|SUPERIORITY||LSM Difference|4.32||||0.0581|TWO_SIDED|95.0|-0.153|8.793||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||8.793|-0.153|0.0581
73876322|NCT03001557|147294707|SUPERIORITY||LSM Difference|-3.437||||0.1777|TWO_SIDED|95.0|-8.481|1.608||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.608|-8.481|0.1777
73876323|NCT03001557|147294707|SUPERIORITY||LSM Difference|1.458||||0.563|TWO_SIDED|95.0|-3.564|6.479||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.479|-3.564|0.5630
73876324|NCT03001557|147294707|SUPERIORITY||LSM Difference|-4.994||||0.0482|TWO_SIDED|95.0|-9.946|-0.041||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-0.041|-9.946|0.0482
73991403|NCT02706951|147529128|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|32.1|||<|0.001|TWO_SIDED|95.0|24.6|39.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||39.7|24.6|<0.001
73991404|NCT02706951|147529129|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-41.53||||0.001|TWO_SIDED|95.0|-66.56|-16.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-16.50|-66.56|0.001
73991405|NCT02706951|147529129|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-49.31|||<|0.001|TWO_SIDED|95.0|-74.23|-24.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-24.40|-74.23|<0.001
73991406|NCT02706951|147529130|SUPERIORITY||Response Rate Difference|26.7|||<|0.001|TWO_SIDED|95.0|18.5|34.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||34.8|18.5|<0.001
73876325|NCT03001557|147294707|SUPERIORITY||LSM Difference|-2.593||||0.3036|TWO_SIDED|95.0|-7.599|2.413||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.413|-7.599|0.3036
73876326|NCT03001557|147294711|SUPERIORITY||LSM Difference|4.845||||0.1991|TWO_SIDED|95.0|-2.624|12.313||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||12.313|-2.624|0.1991
73991407|NCT02706951|147529130|SUPERIORITY||Response Rate Difference|36.8|||<|0.001|TWO_SIDED|95.0|28.6|45.0||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||45.0|28.6|<0.001
74089972|NCT00767520|147732738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.148|||||||Un-stratified log-rank test|||||||0.148
74089973|NCT01338987|147732762|OTHER|||||||0.0075|||||||Wilcoxon's rank sum test|||||||0.0075
74089974|NCT02480582|147732796|SUPERIORITY_OR_OTHER||||||<|0.01||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.||||||<0.01
73876327|NCT03001557|147294711|SUPERIORITY||LSM Difference|-3.872||||0.2982|TWO_SIDED|95.0|-11.263|3.518||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||3.518|-11.263|0.2982
73876328|NCT03001557|147294711|SUPERIORITY||LSM Difference|6.776||||0.0664|TWO_SIDED|95.0|-0.474|14.025||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||14.025|-0.474|0.0664
73876329|NCT03001557|147294711|SUPERIORITY||LSM Difference|3.017||||0.4148|TWO_SIDED|95.0|-4.344|10.379||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||10.379|-4.344|0.4148
73876330|NCT03001557|147294715|SUPERIORITY||LSM Difference|0.063||||0.9599|TWO_SIDED|95.0|-2.452|2.579||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.579|-2.452|0.9599
73876331|NCT03001557|147294715|SUPERIORITY||LSM Difference|-0.238||||0.8541|TWO_SIDED|95.0|-2.817|2.342||Based on a MMRM analysis adjusted for baseline value, country, Visit and treatment by Visit interaction.|MMRM|||||2.342|-2.817|0.8541
73876332|NCT03001557|147294715|SUPERIORITY||LSM Difference|-0.293||||0.8117|TWO_SIDED|95.0|-2.745|2.16||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.160|-2.745|0.8117
73876333|NCT03001557|147294715|SUPERIORITY||LSM Difference|-1.557||||0.2274|TWO_SIDED|95.0|-4.113|1.0||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.000|-4.113|0.2274
73876334|NCT03001557|147294719|SUPERIORITY||LSM Difference|0.086||||0.2421|TWO_SIDED|95.0|-0.06|0.232||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.232|-0.060|0.2421
73876335|NCT03001557|147294719|SUPERIORITY||LSM Difference|-0.012||||0.8661|TWO_SIDED|95.0|-0.155|0.131||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.131|-0.155|0.8661
73876336|NCT03001557|147294719|SUPERIORITY||LSM Difference|0.057||||0.4251|TWO_SIDED|95.0|-0.085|0.199||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.199|-0.085|0.4251
73876337|NCT03001557|147294719|SUPERIORITY||LSM Difference|0.025||||0.7248|TWO_SIDED|95.0|-0.116|0.166||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.166|-0.116|0.7248
74035410|NCT01332019|147623582|SUPERIORITY_OR_OTHER||rate ratio|0.755||||0.0203|TWO_SIDED|95.0|0.595|0.957||q2w/q4w|negative binomial regression|||Based on negative binomial regression for each treatment group, with adjustment for EDSS (\<4 vs. \>=4), relapse rate (based on 1 year before 105MS301 and 105MS301), and age (\<40 vs. \>=40) at 105MS302 baseline.||0.957|0.595|0.0203
74035411|NCT01332019|147623583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0201|TWO_SIDED|95.0|0.59|0.96||Based on Cox proportion hazards model, adjusted for EDSS (\<4 vs \>= 4), age (\<40 vs \>=40), relapse rate (based on one year before 105MS301 and 105MS301), and gadolinium (Gd) enhancing lesions (presence vs. absence) at 105MS302 baseline.|Cox proportion hazards model|||q2w/q4w||0.96|0.59|0.0201
74089975|NCT02480582|147732797|SUPERIORITY_OR_OTHER||||||<|0.05||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in wanting for high fat foods between almonds, cheese savouries and no food.||||||<0.05
73876338|NCT03001557|147294723|SUPERIORITY||LSM Difference|-0.032||||0.2991|TWO_SIDED|95.0|-0.094|0.029||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.029|-0.094|0.2991
73876339|NCT03001557|147294723|SUPERIORITY||LSM Difference|0.033||||0.2861|TWO_SIDED|95.0|-0.028|0.095||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.095|-0.028|0.2861
73991408|NCT02706951|147529131|SUPERIORITY||Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.8|25.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||25.8|13.8|<0.001
73991409|NCT02706951|147529131|SUPERIORITY||Response Rate Difference|30.2|||<|0.001|TWO_SIDED|95.0|23.6|36.9||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||36.9|23.6|<0.001
73991410|NCT01841697|147529139|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 95% confidence interval for the mean difference between omarigilptin and sitagliptin is less than the non-inferiority margin, δ =0.3%, then omarigliptin will be declared non-inferior to sitagliptin in terms of A1C reduction at Week 24.|Difference in least squares mean|-0.03|||||TWO_SIDED|95.0|-0.15|0.08|||||Difference is omarigliptin minus sitagliptin.|Constrained longitudinal data analysis||0.08|-0.15|
74035412|NCT01332019|147623584|SUPERIORITY_OR_OTHER||lesion mean ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.63||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of T2 lesions.|negative binomial regression|||Week 48||0.63|0.41|<0.0001
74089976|NCT02480582|147732798|SUPERIORITY_OR_OTHER||||||<|0.001||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in hunger AUC between almonds, cheese savouries and no food.||||||<0.001
74089977|NCT02480582|147732799|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.||"Energy intake measured by ad-libitum test meals (breakfast, lunch, dinner) during each intervention condition.~Null hypothesis is that there was no difference in total energy intake between almonds, cheese savouries and no food."||||<0.05
74089978|NCT00720226|147732808|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||Participants demonstrating 5-35% emphysema on baseline CT scan||||0.06
73991411|NCT01841697|147529140|SUPERIORITY_OR_OTHER||Difference in percent|-4.3|||||TWO_SIDED|95.0|-11.8|3.2|||||Difference is omarigliptin minus sitagliptin.|||3.2|-11.8|
73876340|NCT03001557|147294723|SUPERIORITY||LSM Difference|-0.052||||0.0938|TWO_SIDED|95.0|-0.113|0.009||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.009|-0.113|0.0938
73876341|NCT03001557|147294723|SUPERIORITY||LSM Difference|0.005||||0.8618|TWO_SIDED|95.0|-0.055|0.066||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.066|-0.055|0.8618
73991412|NCT01841697|147529141|SUPERIORITY_OR_OTHER||Difference in percent|-1.3|||||TWO_SIDED|95.0|-3.6|0.8|||||Difference is omarigliptin minus sitagliptin.|||0.8|-3.6|
73991413|NCT01841697|147529142|SUPERIORITY_OR_OTHER||Difference in least squares mean|-4.2||||0.089|TWO_SIDED|95.0|-9.0|0.6|||Constrained logitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|Difference is omarigliptin minus sitagliptin.|||0.6|-9.0|0.089
73991414|NCT01841697|147529143|SUPERIORITY_OR_OTHER||Between-group rate difference|2.0||||0.619|TWO_SIDED|95.0|-5.9|9.9|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.||9.9|-5.9|0.619
73991415|NCT01841697|147529144|SUPERIORITY_OR_OTHER||Between-group rate difference|4.4||||0.212|TWO_SIDED|95.0|-2.5|11.4|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.||11.4|-2.5|0.212
74035413|NCT01332019|147623584|SUPERIORITY_OR_OTHER||lesion mean ratio|0.49|||<|0.0001|TWO_SIDED|95.0|0.39|0.62||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 302 baseline number of T2 lesions.|negative binomial regression|||Week 96||0.62|0.39|<0.0001
74035414|NCT01332019|147623585|SUPERIORITY_OR_OTHER||lesion mean ratio|0.54|||<|0.0001|TWO_SIDED|95.0|0.43|0.68||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 48||0.68|0.43|<0.0001
73876342|NCT03001557|147294727|SUPERIORITY||LSM Difference|-389.873||||0.0294|TWO_SIDED|95.0|-739.177|-40.569||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-40.569|-739.177|0.0294
74089979|NCT00720226|147732809|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Participants with 5-35% emphysema at baseline||||0.55
73876343|NCT03001557|147294727|SUPERIORITY||LSM Difference|-402.994||||0.0243|TWO_SIDED|95.0|-751.67|-54.319||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-54.319|-751.670|0.0243
73991416|NCT01390441|147529172|NON_INFERIORITY_OR_EQUIVALENCE|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.87|1.16|||ANOVA|||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.||1.16|0.87|
73991417|NCT01390441|147529174|SUPERIORITY_OR_OTHER||Percent difference|-17.2|||||TWO_SIDED|95.0|-38.6|3.6|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part A: MK-8808 500 mg/m\^2 - Part A: MabThera 500 mg/m\^2) when \>=4 participants in an arm experienced an event.||3.6|-38.6|
73991418|NCT01390441|147529174|SUPERIORITY_OR_OTHER||Percent difference|-17.5|||||TWO_SIDED|95.0|-44.4|10.9|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: MabThera 1000 mg) when \>=4 participants in an arm experienced an event.||10.9|-44.4|
73991419|NCT01390441|147529174|SUPERIORITY_OR_OTHER||Percent difference|-5.6|||||TWO_SIDED|95.0|-34.9|24.6|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: Rituxan® 1000 mg) when \>=4 participants in an arm experienced an event.||24.6|-34.9|
73991420|NCT01390441|147529174|SUPERIORITY_OR_OTHER||Percent differnce|12.0|||||TWO_SIDED|95.0|-15.6|38.9|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MabThera® 1000 mg - Part B: Rituxan® 1000 mg) when \>=4 participants in an arm experienced an event.||38.9|-15.6|
73991421|NCT01390441|147529176|NON_INFERIORITY_OR_EQUIVALENCE|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|0.98|||||TWO_SIDED|90.0|0.87|1.1|||ANOVA|||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.||1.1|0.87|
73991422|NCT01390441|147529180|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|The model included a term for treatment.||Estimated difference vs MabThera® at 6 weeks.||0.5|-0.9|
73991423|NCT01390441|147529180|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|The model included a term for treatment.||Estimated difference vs MabThera® at 12 weeks.||1.2|-0.4|
73991424|NCT01407276|147529183|SUPERIORITY_OR_OTHER||GMR|0.94|||||TWO_SIDED|90.0|0.8|1.11|||Geometric mean ratio (GMR)|GMR of Panel A:Panel B||||1.11|0.80|
73991425|NCT01407276|147529183|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.34|||||TWO_SIDED|90.0|1.12|1.61|||GMR of Panel C:Panel D|||||1.61|1.12|
73991426|NCT01407276|147529183|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.56|||||TWO_SIDED|90.0|1.32|1.85|||GMR of Panel E:Panel F|||||1.85|1.32|
73991427|NCT01407276|147529183|SUPERIORITY_OR_OTHER||GMR or Panel G:Panel H|1.89|||||TWO_SIDED|90.0|1.4|2.55|||GMR of Panel G:Panel H|||||2.55|1.40|
73991428|NCT01407276|147529183|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.97|||||TWO_SIDED|90.0|1.46|2.66|||GMR of Panel G:Panel H|||||2.66|1.46|
73991429|NCT01407276|147529184|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.94|||||TWO_SIDED|90.0|0.79|1.12|||GMR of Panel A:Panel B|||||1.12|0.79|
73991430|NCT01407276|147529184|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.13|||||TWO_SIDED|90.0|0.91|1.41|||GMR of Panel C:Panel D|||||1.41|0.91|
73991431|NCT01407276|147529184|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.9|||||TWO_SIDED|90.0|0.66|1.23|||GMR of Panel E:Panel F|||||1.23|0.66|
74089980|NCT01769274|147732970|OTHER|||||||1|||||||Hierarchical rank test|||||||1.0000
73876344|NCT03001557|147294727|SUPERIORITY||LSM Difference|-141.026||||0.4209|TWO_SIDED|95.0|-489.805|207.752||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||207.752|-489.805|0.4209
73991432|NCT01407276|147529184|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.74|||||TWO_SIDED|90.0|0.57|0.96|||GMR of Panel E:Panel F|||||0.96|0.57|
73991433|NCT01407276|147529184|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.73|||||TWO_SIDED|90.0|0.56|0.95|||GMR of Panel E:Panel F|||||0.95|0.56|
73991434|NCT01407276|147529185|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.92|||||TWO_SIDED|90.0|0.81|1.05|||GMR of Panel A:Panel B|||||1.05|0.81|
73991435|NCT01407276|147529185|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.33||||||90.0|1.07|1.65|||GMR of Panel C:Panel D|||||1.65|1.07|
73991436|NCT01407276|147529185|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.37|||||TWO_SIDED|90.0|1.13|1.65|||GMR of Panel E:Panel F|||||1.65|1.13|
73991437|NCT01407276|147529185|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.38|||||TWO_SIDED|90.0|1.06|1.79|||GMR of Panel G:Panel H|||||1.79|1.06|
73991438|NCT01407276|147529185|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.3|||||TWO_SIDED|90.0|1.0|1.68|||GMR of Panel G:Panel H|||||1.68|1.00|
73991439|NCT01407276|147529186|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.92|||||TWO_SIDED|90.0|0.75|1.12|||GMR of Panel A:Panel B|||||1.12|0.75|
73991440|NCT01407276|147529186|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.45|||||TWO_SIDED|90.0|1.19|1.76|||GMR of Panel C:Panel D|||||1.76|1.19|
73991441|NCT01407276|147529186|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.83|||||TWO_SIDED|90.0|1.49|2.24|||GMR of Panel E:Panel F|||||2.24|1.49|
73991442|NCT01407276|147529186|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.9|||||TWO_SIDED|90.0|1.41|2.54|||GMR of Panel G:Panel H|||||2.54|1.41|
74089981|NCT01769274|147732970|OTHER|||||||1|||||||Hierarchical rank test|||||||1.0000
73991443|NCT01407276|147529186|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.88|||||TWO_SIDED|90.0|1.4|2.52|||GMR of Panel G:Panel H|||||2.52|1.40|
73991444|NCT01407276|147529187|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|1.11|||||TWO_SIDED|90.0|0.87|1.42|||GMR of Panel A:Panel B|||||1.42|0.87|
73991445|NCT01407276|147529187|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.75|||||TWO_SIDED|90.0|0.53|1.07|||GMR of Panel C:Panel D|||||1.07|0.53|
74089982|NCT02377063|147732980|OTHER||Mean Difference (Final Values)|-11.2||||0.014|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Firmicutes after juice consumption||||0.014
74089983|NCT02377063|147732980|OTHER||Mean Difference (Final Values)|10.5||||0.026|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Bacteroidetes after juice consumption||||0.026
73991446|NCT01407276|147529187|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.68|||||TWO_SIDED|90.0|0.51|0.92|||GMR of Panel E:Panel F|||||0.92|0.51|
73991447|NCT01407276|147529187|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.7|||||TWO_SIDED|90.0|0.5|0.98|||GMR of Panel G:Panel H|||||0.98|0.50|
73991448|NCT01407276|147529187|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.8|||||TWO_SIDED|90.0|0.57|1.12|||GMR of Panel G:Panel H|||||1.12|0.57|
73991449|NCT01407276|147529188|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|1.06|||||TWO_SIDED|90.0|0.9|1.25|||GMR of Panel A:Panel B|||||1.25|0.90|
73991450|NCT01407276|147529188|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.75|||||TWO_SIDED|90.0|0.62|0.89|||GMR of Panel C:Panel D|||||0.89|0.62|
73991451|NCT01407276|147529188|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.64|||||TWO_SIDED|90.0|0.54|0.76|||GMR of Panel E:Panel F|||||0.76|0.54|
73991452|NCT01407276|147529188|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.53|||||TWO_SIDED|90.0|0.39|0.71|||GMR of Panel G:Panel H|||||0.71|0.39|
73991453|NCT01407276|147529188|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.51|||||TWO_SIDED|90.0|0.38|0.68|||GMR of Panel G:Panel H|||||0.68|0.38|
73991454|NCT01407276|147529189|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.93|||||TWO_SIDED|90.0|0.74|1.18|||GMR of Panel A:Panel B|||||1.18|0.74|
73991455|NCT01407276|147529189|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.73|||||TWO_SIDED|90.0|0.55|0.96|||GMR of Panel C:Panel D|||||0.96|0.55|
73991456|NCT01407276|147529189|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.42|||||TWO_SIDED|90.0|0.33|0.54|||GMR of Panel E:Panel F|||||0.54|0.33|
73991457|NCT01407276|147529190|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.86|||||TWO_SIDED|90.0|0.69|1.07|||GMR of Panel A:Panel B|||||1.07|0.69|
73991458|NCT01407276|147529190|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.9|||||TWO_SIDED|90.0|0.7|1.15|||GMR of Panel C:Panel D|||||1.15|0.70|
73991459|NCT01407276|147529190|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.5|||||TWO_SIDED|90.0|0.37|0.67|||GMR of Panel E:Panel F|||||0.67|0.37|
74035415|NCT01332019|147623585|SUPERIORITY_OR_OTHER||lesion mean ratio|0.55|||<|0.0001|TWO_SIDED|95.0|0.43|0.71||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 96||0.71|0.43|<0.0001
74035416|NCT01332019|147623586|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 48||||<0.0001
73991460|NCT01407276|147529191|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.86|||||TWO_SIDED|90.0|0.69|1.07|||GMR of Panel A:Panel B|||||1.07|0.69|
74035417|NCT01332019|147623586|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 96||||<0.0001
74035418|NCT01332019|147623587|SUPERIORITY_OR_OTHER|||||||0.0012||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 48||||0.0012
73991461|NCT01407276|147529191|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.9|||||TWO_SIDED|90.0|0.7|1.15|||GMR of Panel C:Panel D|||||1.15|0.70|
73991462|NCT01407276|147529191|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.5|||||TWO_SIDED|90.0|0.37|0.67|||GMR of Panel E:Panel F|||||0.67|0.37|
73991463|NCT02635386|147529196|SUPERIORITY||||||<|0.02|||||||ANOVA|nested repeated measure||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.02
73991464|NCT02635386|147529197|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
73991465|NCT02635386|147529198|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
73991466|NCT02635386|147529199|SUPERIORITY||||||<|0.0001|||||||ANOVA|one way with Bonferroni contrast||One way ANOVA with Bonferroni test to compare differences between groups if significant||||<0.0001
73991467|NCT02635386|147529200|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
73991468|NCT02635386|147529201|SUPERIORITY||||||<|0.05|||||||ANOVA|Nested repeated measure design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.05
73991469|NCT02635386|147529202|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
73991470|NCT02635386|147529203|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
73991471|NCT02635386|147529204|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
73991472|NCT02635386|147529205|SUPERIORITY||||||<|0.01|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.01
74035419|NCT01332019|147623587|SUPERIORITY_OR_OTHER|||||||0.0026||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 96||||0.0026
73876345|NCT03001557|147294727|SUPERIORITY||LSM Difference|-367.845||||0.0398|TWO_SIDED|95.0|-717.87|-17.82||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-17.820|-717.870|0.0398
73991473|NCT02635386|147529206|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
73991474|NCT02635386|147529207|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
73991475|NCT02635386|147529208|SUPERIORITY||||||<|0.02|||||||ANOVA|nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.02
73991476|NCT02635386|147529209|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
73991477|NCT02635386|147529210|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
73991478|NCT02635386|147529211|SUPERIORITY||||||<|0.04|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.04
73876346|NCT03001557|147294731|SUPERIORITY||LSM Difference|-1276.18||||0.1162|TWO_SIDED|95.0|-2878.587|326.226||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||326.226|-2878.587|0.1162
73876347|NCT03001557|147294731|SUPERIORITY||LSM Difference|227.464||||0.7781|TWO_SIDED|95.0|-1382.85|1837.777||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1837.777|-1382.850|0.7781
73991479|NCT02635386|147529212|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||>0.05
73991480|NCT02635386|147529213|SUPERIORITY||||||<|0.04|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.04
73991481|NCT02635386|147529214|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
73991482|NCT02635386|147529215|SUPERIORITY||||||<|0.05|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.05
73991483|NCT02635386|147529216|SUPERIORITY||||||<|0.001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.001
73991484|NCT02635386|147529217|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
73991485|NCT02635386|147529218|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
73991486|NCT02446613|147529219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.41|5.43|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1071.|||5.43|-1.41|
74089984|NCT03020719|147732990|SUPERIORITY||Mean Difference (Final Values)|-0.081||||0.2521|TWO_SIDED|95.0|-0.221|0.059|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\< 6 years, ≥ 6 years), and baseline weight-for-age z-score category (\< -0.52, ≥ -0.52).|Model incorporates Week 12 weight-for-age z-score, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.059|-0.221|0.2521
73876348|NCT03001557|147294731|SUPERIORITY||LSM Difference|-620.581||||0.4255|TWO_SIDED|95.0|-2170.342|929.179||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||929.179|-2170.342|0.4255
73991487|NCT02446613|147529220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.98|3.75|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2417.|||3.75|-1.98|
73991488|NCT02446613|147529221|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.4|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.08|1.87|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2876.|||1.87|-1.08|
73991489|NCT02446613|147529222|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.9|STANDARD_DEVIATION|0.006|||TWO_SIDED|95.0|-1.86|5.34|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1453.|||5.34|-1.86|
73991490|NCT02446613|147529223|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.6|STANDARD_DEVIATION|0.006|||TWO_SIDED|95.0|-10.7|19.71|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2665.|||19.71|-10.70|
73991491|NCT02446613|147529224|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.3|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-14.97|24.38|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.3266|||24.38|-14.97|
73991492|NCT02446613|147529225|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.1|STANDARD_DEVIATION|0.008|||TWO_SIDED|95.0|-17.47|19.2|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.4528|||19.20|-17.47|
73991493|NCT02446613|147529226|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.6|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-13.69|28.04|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2525|||28.04|-13.69|
73991494|NCT01062269|147529228|SUPERIORITY_OR_OTHER||||||<|0.05||||||Differences between test products were assessed by repeated measures analysis of variance. If sequence was not found to be statistically significant(p\>0.05),then it was removed from the final model.|measures analysis of variance|Differences between test powders assessed by repeated measures analysis of variance, pairwise comparisons between treatments by Scheffe procedure.||"The BASA scale components were derived from the parameters best shown to differentiate acceptability between different BAS preparations (taste and texture),as well as other parameters useful for differentiating between different BAS preparations(appearance and mixability). The scale was then weighted based upon an Importance of Acceptability questionnaire regarding the individual scale components. The developed scale should reasonably allow for future comparisons of differing BAS formulations."||||<0.05
73991495|NCT02706847|147529257|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|36.2|||<|0.001|TWO_SIDED|95.0|26.2|46.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||46.2|26.2|<0.001
73991496|NCT02706847|147529257|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.0|||<|0.001|TWO_SIDED|95.0|17.8|38.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||38.1|17.8|<0.001
73991497|NCT02706847|147529258|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|29.1|||<|0.001|TWO_SIDED|95.0|19.9|38.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||38.3|19.9|<0.001
73991498|NCT02706847|147529258|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.2|||<|0.001|TWO_SIDED|95.0|19.0|37.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||37.4|19.0|<0.001
73991499|NCT02706847|147529259|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.57|-1.01||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.01|-1.57|<0.001
74089985|NCT03020719|147732991|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.089|TWO_SIDED|95.0|-0.18|0.01|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.01|-0.18|0.0890
74089986|NCT03020719|147732992|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.573|TWO_SIDED|95.0|-0.28|0.15|||Mixed Models Analysis|Model adjusted from randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.15|-0.28|0.5730
73876349|NCT03001557|147294731|SUPERIORITY||LSM Difference|-577.82||||0.4672|TWO_SIDED|95.0|-2160.337|1004.697||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1004.697|-2160.337|0.4672
74009228|NCT01380730|147569256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.6|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-58.0|-43.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.1|-58.0|<0.001
74009229|NCT01380730|147569257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.4|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|-66.37|-56.43||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-56.43|-66.37|<0.001
74009230|NCT01380730|147569257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.42|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-60.37|-50.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-50.47|-60.37|<0.001
73876350|NCT03001557|147294735|SUPERIORITY||LSM Difference|-839.088||||0.2984|TWO_SIDED|95.0|-2440.854|762.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||762.678|-2440.854|0.2984
73876351|NCT03001557|147294735|SUPERIORITY||LSM Difference|651.922||||0.4218|TWO_SIDED|95.0|-962.835|2266.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2266.678|-962.835|0.4218
73991500|NCT02706847|147529259|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.28|||<|0.001|TWO_SIDED|95.0|-1.56|-0.99||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.99|-1.56|<0.001
73991501|NCT02706847|147529260|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.34|-0.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.10|-0.34|<0.001
73991502|NCT02706847|147529260|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.25|||<|0.001|TWO_SIDED|95.0|-0.38|-0.13||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.13|-0.38|<0.001
73991503|NCT02706847|147529261|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean DIfference|3.44|||<|0.001|TWO_SIDED|95.0|1.72|5.15||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.15|1.72|<0.001
73991504|NCT02706847|147529261|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.63|||<|0.001|TWO_SIDED|95.0|2.89|6.36||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.36|2.89|<0.001
73991505|NCT02706847|147529262|SUPERIORITY||Response Rate Difference|22.3|||<|0.001|TWO_SIDED|95.0|13.6|31.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||31.1|13.6|<0.001
73991506|NCT02706847|147529262|SUPERIORITY||Response Rate Difference|23.9|||<|0.001|TWO_SIDED|95.0|15.1|32.7||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||32.7|15.1|<0.001
73991507|NCT02706847|147529263|SUPERIORITY||Response Rate Difference|5.1||||0.11|TWO_SIDED|95.0|-1.1|11.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||11.2|-1.1|0.110
73991508|NCT02706847|147529263|SUPERIORITY||Response Rate Difference|16.5|||<|0.001|TWO_SIDED|95.0|9.1|23.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||23.9|9.1|<0.001
73991509|NCT02706847|147529264|SUPERIORITY||Response Rate Difference|16.8|||<|0.001|TWO_SIDED|95.0|8.5|25.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||25.1|8.5|<0.001
73991510|NCT02706847|147529264|SUPERIORITY||Response Rate Difference|14.2|||<|0.001|TWO_SIDED|95.0|6.1|22.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||22.3|6.1|<0.001
73991511|NCT01174264|147529265|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.75||||0.003|TWO_SIDED|90.0|1.3|2.34|||t-test, 2 sided|Performed on log-transformed data.||||2.34|1.30|0.003
73991512|NCT01174264|147529265|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.08||||0.65|TWO_SIDED|90.0|0.81|1.44||Performed on log-transformed data.|t-test, 2 sided|||||1.44|0.81|0.65
73991513|NCT01174264|147529266|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.74||||0.008|TWO_SIDED|90.0|1.25|2.42|||t-test, 2 sided|Performed on log-transformed data.||||2.42|1.25|0.008
73876352|NCT03001557|147294735|SUPERIORITY||LSM Difference|-447.245||||0.5655|TWO_SIDED|95.0|-1998.44|1103.95||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1103.950|-1998.440|0.5655
73991514|NCT01174264|147529266|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.12||||0.51|TWO_SIDED|90.0|0.84|1.49|||t-test, 2 sided|Performed on log-transformed data.||||1.49|0.84|0.51
73991515|NCT01174264|147529268|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.83
73991516|NCT01174264|147529268|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
73991517|NCT01174264|147529269|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
73991518|NCT01174264|147529269|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
73991519|NCT01174264|147529270|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.16||||0.17|TWO_SIDED|90.0|0.97|1.38|||t-test, 2 sided|Performed on log-transformed data.||||1.38|0.97|0.17
73991520|NCT01174264|147529271|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.13||||0.25|TWO_SIDED|90.0|0.95|1.35|||t-test, 2 sided|Performed on log-transformed data.||||1.35|0.95|0.25
73991521|NCT01174264|147529272|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.22||||0.096|TWO_SIDED|90.0|1.0|1.48||Performed on log-transformed data.|t-test, 2 sided|||||1.48|1.00|0.096
73991522|NCT01174264|147529273|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
73991523|NCT02353871|147529285|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
73991524|NCT02353871|147529286|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 8 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
73991525|NCT02353871|147529286|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 15 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
73991526|NCT02353871|147529286|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 57 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
73991527|NCT02353871|147529286|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 85 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
73991528|NCT02353871|147529286|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 113 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
73991529|NCT02353871|147529286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 148 - BTX-A-HAC NG solution (50 U) versus placebo||||0.0035
73991530|NCT02353871|147529286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0441||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 183 (End of Study) - BTX-A-HAC NG solution (50 U) versus placebo||||0.0441
73991531|NCT02353871|147529287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2422||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 57 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.2422
73991532|NCT02353871|147529287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0917||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 85 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.0917
73991533|NCT02353871|147529287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7064||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 113 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7064
73991534|NCT02353871|147529287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 148 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7010
73991535|NCT02353871|147529287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7894||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 183 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7894
73991536|NCT02353871|147529288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
73991537|NCT02353871|147529288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
73991538|NCT02353871|147529288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
73991539|NCT02353871|147529288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
73991540|NCT02353871|147529288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||<0.0001
73876353|NCT03001557|147294735|SUPERIORITY||LSM Difference|-130.603||||0.8686|TWO_SIDED|95.0|-1706.478|1445.272||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1445.272|-1706.478|0.8686
73991541|NCT02353871|147529288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
73991542|NCT02353871|147529288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0015||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.0015
73991543|NCT02353871|147529289|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
73991544|NCT02353871|147529289|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
73991545|NCT02353871|147529289|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
73991546|NCT02353871|147529289|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
73991547|NCT02353871|147529289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||0.0008
73991548|NCT02353871|147529289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0065||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||0.0065
73991549|NCT02353871|147529289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0643||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||0.0643
73991550|NCT02353871|147529289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.3670
74089987|NCT03020719|147732993|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.4259|TWO_SIDED|95.0|-0.17|0.4|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.40|-0.17|0.4259
73876354|NCT03001557|147294739|SUPERIORITY||LSM Difference|0.02||||0.4638|TWO_SIDED|95.0|-0.034|0.074||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.074|-0.034|0.4638
73991551|NCT02353871|147529290|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
73991552|NCT02353871|147529290|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
73991553|NCT02353871|147529290|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
73991554|NCT02353871|147529290|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
73991555|NCT02353871|147529290|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - Dysport 50 U versus Placebo at Day 85||||<0.0001
73991556|NCT02353871|147529290|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
74089988|NCT03020719|147732994|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.4666|TWO_SIDED|95.0|-2.06|0.96|||ANCOVA|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).||||0.96|-2.06|0.4666
73991557|NCT02353871|147529290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||0.0011
74089989|NCT03020719|147732995|SUPERIORITY||Difference in % of Participants with AE|0.0||||1|TWO_SIDED|95.0|-13.6|13.6|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.|||13.6|-13.6|1.0000
74089990|NCT03020719|147732995|SUPERIORITY||Difference in % of Participants with SAE|-13.3||||0.1945|TWO_SIDED|95.0|-30.5|2.9|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.|||2.9|-30.5|0.1945
74089991|NCT03020719|147732996|SUPERIORITY||Rate Ratio|1.21||||0.1087|TWO_SIDED|95.0|0.96|1.52|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.||1.52|0.96|0.1087
74089992|NCT03020719|147732996|SUPERIORITY||Rate Ratio|0.12||||0.0122|TWO_SIDED|95.0|0.01|0.67|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.||0.67|0.01|0.0122
73876355|NCT03001557|147294739|SUPERIORITY||LSM Difference|0.06||||0.0322|TWO_SIDED|95.0|0.005|0.115||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.115|0.005|0.0322
73991558|NCT02353871|147529290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0036||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.0036
73991559|NCT02353871|147529291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
73991560|NCT02353871|147529291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
73991561|NCT02353871|147529291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
73991562|NCT02353871|147529291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
73991563|NCT02353871|147529291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||<0.0001
73991564|NCT02353871|147529291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
73991565|NCT02353871|147529291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||<0.0001
74089993|NCT01392326|147732999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53|||<|0.0001|TWO_SIDED|95.0|3.46|8.85|||Regression, Logistic|||||8.85|3.46|<0.0001
73876356|NCT03001557|147294739|SUPERIORITY||LSM Difference|0.003||||0.9144|TWO_SIDED|95.0|-0.051|0.056||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.056|-0.051|0.9144
73991566|NCT02353871|147529291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||<0.0001
73991567|NCT02353871|147529292|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus Placebo||||<0.0001
73991568|NCT02353871|147529292|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.561|||<|0.0001|TWO_SIDED||||||Cox proportional hazard model|Centre, gender and ILA baseline severity score used as covariates.||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
73991569|NCT03434028|147529311|SUPERIORITY||difference in mortality rate|-0.9||||0.61|TWO_SIDED|95.0|-4.4|2.6|||Z-test|||||2.6|-4.4|0.61
73991570|NCT03434028|147529312|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||||The mean values is an estimate from the Kaplan-Meier curve, thus it is correct as reported.|||1.2|-0.5|
73991571|NCT03434028|147529313|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.4|1.6||||||||1.6|-0.4|
74089994|NCT01392326|147732999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.39|||<|0.0001|TWO_SIDED|95.0|3.37|8.62|||Regression, Logistic|||||8.62|3.37|<0.0001
74089995|NCT02508259|147733014|EQUIVALENCE|The null hypothesis was that before and after treatment ADOS scores were equivalent.|Mean Difference (Net)|-1.6|STANDARD_DEVIATION|0.55||0.0028|TWO_SIDED|95.0|-2.3|-0.9|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.9|-2.3|0.0028
73876357|NCT03001557|147294739|SUPERIORITY||LSM Difference|0.057||||0.0364|TWO_SIDED|95.0|0.004|0.11||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction|MMRM|||||0.110|0.004|0.0364
73991572|NCT03434028|147529314|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.8|1.2||||||||1.2|-0.8|
73991573|NCT03434028|147529315|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.5|1.3||||||||1.3|-0.5|
73991574|NCT03434028|147529316|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.8|1.0||||||||1.0|-0.8|
73991575|NCT03434028|147529317|SUPERIORITY||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-0.3|1.9||||||||1.9|-0.3|
73991576|NCT03434028|147529318|SUPERIORITY||Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-5.1|1.7||||||||1.7|-5.1|
73991577|NCT03434028|147529319|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.8|1.8||||||||1.8|-1.8|
73991578|NCT03434028|147529320|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
73991579|NCT03434028|147529321|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.3|0.4||||||||0.4|-0.3|
73991580|NCT03434028|147529322|SUPERIORITY||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-1.7|1.5||||||||1.5|-1.7|
73991581|NCT03434028|147529323|SUPERIORITY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-3.7|1.7||||||||1.7|-3.7|
73991582|NCT03434028|147529324|SUPERIORITY||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-3.6|4.7||||||||4.7|-3.6|
73991583|NCT02037776|147529325|SUPERIORITY|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups in Rikkunshito Placebo and Rikkunshito, based on the count of participants categorized in 1 (Significantly improved) through 7 (Much worse), using the Wilcoxon (Mann-Whitney).||||0.038
73991584|NCT02037776|147529326|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in all symptoms of modified FSSG||||0.027
73991585|NCT02037776|147529326|SUPERIORITY|||||||0.089|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in GERD symptoms of modified FSSG||||0.089
73991586|NCT02037776|147529326|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in dyspeptic symptoms of modified FSSG||||0.148
74089996|NCT02508259|147733015|EQUIVALENCE|The child-specific difference in EOWPVT scores were compared for equivalence before and 6-weeks after suramin treatment|Mean Difference (Net)|-4.2|STANDARD_DEVIATION|8.3||0.32|TWO_SIDED|95.0|-14.5|6.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||6.1|-14.5|0.32
73991587|NCT02037776|147529327|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in total score of PAGI-SYM||||0.051
73991588|NCT02037776|147529327|SUPERIORITY|||||||0.947|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Heartburn/Regurgitation of PAGI-SYM||||0.947
73991589|NCT02037776|147529327|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Nausea/Vomiting of PAGI-SYM||||0.157
73991590|NCT02037776|147529327|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Postprandial Fullness/Early satiety of PAGI-SYM||||0.004
73991591|NCT02037776|147529327|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Bloating of PAGI-SYM||||0.011
73991592|NCT02037776|147529327|SUPERIORITY|||||||0.245|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Upper Abdominal Pain of PAGI-SYM||||0.245
73991593|NCT02037776|147529327|SUPERIORITY|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Lower Abdominal Pain of PAGI-SYM||||0.387
73991594|NCT02037776|147529328|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||||||0.034
73991595|NCT02037776|147529329|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in PCS of SF-8||||0.270
73991596|NCT02037776|147529329|SUPERIORITY|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in MCS of SF-8||||0.342
73991597|NCT02037776|147529330|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in overall point score of HAD||||0.036
73991598|NCT02037776|147529330|SUPERIORITY|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in depression point score of HAD||||0.084
73991599|NCT02037776|147529330|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in anxiety point score of HAD||||0.022
73991600|NCT01963169|147529331|SUPERIORITY||Effect size|0.54|||<|0.001|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for Knowledge outcome using the revised Osteoporosis Knowledge Test.|At 8 week, both intervention groups received the same Bone Power Program intervention. Thus, the analysis for the 8-week outcomes was completed as a two-armed RCT.||||< 0.001
73991601|NCT01963169|147529331|SUPERIORITY||Effect size|0.33|||<|0.001|TWO_SIDED|||||\<0.05 (threshold)|Mixed Models Analysis||The above values are for the exercise behavior variable assessed by the 9-item Self-Efficacy for Exercise scale.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||<0.001
73991602|NCT01963169|147529331|SUPERIORITY||Effect size|0.2||||0.009|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for calcium outcome expectation..|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.009
73991603|NCT01963169|147529331|SUPERIORITY||Effect Size|0.18||||0.002|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise self-efficacy.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.002
73991604|NCT01963169|147529331|SUPERIORITY||Effect size|0.14||||0.032|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise outcome expectation.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.032
73991605|NCT03786744|147529339|SUPERIORITY||Mean Difference (Net)|9.0||||0.049367|TWO_SIDED|||||Alternative hypothesis: can be changed of speech, language, communication skills for Cord Blood versus Placebo groups in 2-month Threshold \<0.05|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.049367
74035420|NCT01332019|147623593|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.57||||0.006|TWO_SIDED|95.0|0.38|0.85||Based on Cox Proportional Hazards model, adjusted for 105MS302 baseline EDSS and age (\<40 vs \>=40).|Cox Proportional Hazards model||q2w/q4w|||0.85|0.38|0.0060
73991606|NCT03786744|147529339|SUPERIORITY||Median Difference (Net)|9.0||||0.004072|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 2-month of Health/Physical Development/Behaviour for Cord Blood versus Control groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.||||0.004072
73991607|NCT03786744|147529339|SUPERIORITY||Mean Difference (Net)|9.0||||0.017258|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 12-month of Health/Physical Development/Behaviour for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.||||0.017258
73991608|NCT03786744|147529339|SUPERIORITY||Mean Difference (Net)|10.0||||0.03121|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 1-month of total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.031210
73991609|NCT03786744|147529339|SUPERIORITY||Mean Difference (Net)|24.0||||0.00194|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 2-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.001940
73991610|NCT03786744|147529339|SUPERIORITY||Mean Difference (Net)|15.0||||0.03121|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 6-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.031210
73991611|NCT03786744|147529339|SUPERIORITY||Mean Difference (Net)|16.0||||0.01133|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 12-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.011330
73991612|NCT04683510|147529351|SUPERIORITY||Odds Ratio (OR)|1.647||||0.2345|TWO_SIDED|95.0|0.724|3.746|||Regression, Logistic|||||3.746|0.724|0.2345
73991613|NCT04683510|147529351|SUPERIORITY||Odds Ratio (OR)|1.897||||0.124|TWO_SIDED|95.0|0.839|4.291|||Regression, Logistic|||||4.291|0.839|0.124
73991614|NCT04683510|147529352|SUPERIORITY||Odds Ratio (OR)|0.905||||0.2352|TWO_SIDED|95.0|0.768|1.067|||Regression, Logistic|||||1.067|0.768|0.2352
73991615|NCT04683510|147529352|SUPERIORITY||Odds Ratio (OR)|0.924||||0.3418|TWO_SIDED|95.0|0.785|1.088|||Regression, Logistic|||||1.088|0.785|0.3418
73991616|NCT04683510|147529353|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1653|TWO_SIDED|95.0|0.921|1.615|||Regression, Logistic|||||1.615|0.921|0.1653
74035421|NCT02190747|147623670|OTHER|||||||0.1664|||||||Cochran-Armitage test of trend|||Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.1664
74035422|NCT02190747|147623671|OTHER|||||||0.2335|||||||Cochran-Armitage test of trend|||Week 6: Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.2335
74089997|NCT02508259|147733016|EQUIVALENCE|In this analysis, the null hypothesis was tested that the child-specific ABC subscores for stereotypy were unchanged before and after suramin treatment.|Mean Difference (Net)|-4.0|STANDARD_DEVIATION|2.3||0.019|TWO_SIDED|95.0|-6.9|-1.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-1.1|-6.9|0.019
74035423|NCT02190747|147623671|OTHER|||||||0.0837|||||||Cochran-Armitage test of trend|||Week 12: Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.0837
74089998|NCT02508259|147733017|EQUIVALENCE|In this analysis, we tested the equivalence of the child-specific ATEC subscore for language before and 6-weeks after treatment with suramin.|Mean Difference (Net)|-2.0|STANDARD_DEVIATION|1.4||0.034|TWO_SIDED|95.0|-2.7|-0.49|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.49|-2.7|0.034
73991617|NCT04683510|147529353|SUPERIORITY||Odds Ratio (OR)|1.213||||0.181|TWO_SIDED|95.0|0.914|1.609|||Regression, Logistic|||||1.609|0.914|0.181
73991618|NCT03522389|147529370|SUPERIORITY|||||||0.003|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.003
73991619|NCT03522389|147529370|SUPERIORITY||||||<|0.001|||||||ANOVA|||1-month follow up - Baseline (T3-T1)||||<0.001
73991620|NCT03522389|147529370|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
73991621|NCT03522389|147529370|SUPERIORITY|||||||0.006|||||||ANOVA|||Within group comparison||||0.006
73991622|NCT03522389|147529370|SUPERIORITY|||||||0.793|||||||ANOVA|||Within group comparison||||0.793
73991623|NCT03522389|147529371|SUPERIORITY||||||<|0.001|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||<0.001
73991624|NCT03522389|147529371|SUPERIORITY|||||||0.039|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.039
73991625|NCT03522389|147529371|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
73991626|NCT03522389|147529371|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
73991627|NCT03522389|147529371|SUPERIORITY|||||||0.117|||||||ANOVA|||Within group comparison||||0.117
73991628|NCT03522389|147529372|SUPERIORITY|||||||0.924|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.924
73991629|NCT03522389|147529372|SUPERIORITY|||||||0.855|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.855
73991630|NCT03522389|147529372|SUPERIORITY|||||||0.937|||||||ANOVA|||Within group comparison||||0.937
73991631|NCT03522389|147529372|SUPERIORITY|||||||0.97|||||||ANOVA|||Within group comparison||||0.970
73991632|NCT03522389|147529372|SUPERIORITY|||||||0.242|||||||ANOVA|||Within group comparison||||0.242
73991633|NCT03522389|147529373|SUPERIORITY|||||||0.161|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.161
73991634|NCT03522389|147529373|SUPERIORITY|||||||0.161|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.161
73991635|NCT03522389|147529373|SUPERIORITY|||||||0.076|||||||ANOVA|||Within group comparison||||0.076
73991636|NCT03522389|147529373|SUPERIORITY|||||||0.211|||||||ANOVA|||Within group comparison||||0.211
73991637|NCT03522389|147529373|SUPERIORITY|||||||0.573|||||||ANOVA|||Within group comparison||||0.573
73991638|NCT03522389|147529374|SUPERIORITY|||||||0.445|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.445
73991639|NCT03522389|147529374|SUPERIORITY|||||||0.046|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.046
73991640|NCT03522389|147529374|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
73991641|NCT03522389|147529374|SUPERIORITY|||||||0.028|||||||ANOVA|||Within group comparison||||0.028
73991642|NCT03522389|147529374|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
73991643|NCT04750577|147529375|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0245|||||||MCP-Mod exponential model fit|Model assumption: 20% of the maximum effect is achieved at 3 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0245
73991644|NCT04750577|147529375|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0294|||||||MCP-Mod linear model fit|Model assumption: No assumption was needed.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0294
73991645|NCT04750577|147529375|OTHER|A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||||0.0468||||||MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.|MCP-Mod quadratic model fit|Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||||||0.0468
73991646|NCT04750577|147529375|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0586|||||||MCP-Mod Emax model fit|Model assumption: 80% of the maximum effect is achieved at 6 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0586
73991647|NCT04750577|147529375|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0659|||||||MCP-Mod Sigmoid emax model fit|Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0659
73991648|NCT04750577|147529375|OTHER||Mean Difference (Net)|-0.103||||0.3224|TWO_SIDED|95.0|-0.309|0.102|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 1 mg BI 685509 TID- Least Squares Mean ofPlacebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.102|-0.309|0.3224
73991649|NCT04750577|147529375|OTHER||Mean Difference (Net)|-0.063||||0.5616|TWO_SIDED|95.0|-0.275|0.15|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 2 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.150|-0.275|0.5616
73991650|NCT04750577|147529375|OTHER||Mean Difference (Net)|-0.251||||0.0183|TWO_SIDED|95.0|-0.459|-0.043|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 3 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.043|-0.459|0.0183
73991651|NCT04750577|147529376|OTHER||Mean Difference (Net)|-0.211||||0.0396|TWO_SIDED|0.95|-0.413|-0.01|||Mixed Models Analysis||"Least Squares Mean of 1 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.010|-0.413|0.0396
73991652|NCT04750577|147529376|OTHER||Mean Difference (Net)|-0.12||||0.2568|TWO_SIDED|0.95|-0.327|0.088|||Mixed Models Analysis||"Least Squares Mean of 2 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.088|-0.327|0.2568
73991653|NCT04750577|147529376|OTHER||Mean Difference (Net)|-0.357||||0.0006|TWO_SIDED|0.95|-0.56|-0.154|||Mixed Models Analysis||"Least Squares Mean of 3 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.154|-0.560|0.0006
73991654|NCT04750577|147529377|OTHER||Odds Ratio (OR)|2.25||||0.0519|TWO_SIDED|95.0|0.99|5.1|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||5.10|0.99|0.0519
73991655|NCT04750577|147529377|OTHER||Odds Ratio (OR)|1.43||||0.4159|TWO_SIDED|95.0|0.61|3.36|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||3.36|0.61|0.4159
73991656|NCT04750577|147529377|OTHER||Odds Ratio (OR)|2.9||||0.0106|TWO_SIDED|95.0|1.28|6.55|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||6.55|1.28|0.0106
73991657|NCT04750577|147529378|OTHER||Odds Ratio (OR)|2.79||||0.0176|TWO_SIDED|95.0|1.2|6.53|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||6.53|1.20|0.0176
73991658|NCT04750577|147529378|OTHER||Odds Ratio (OR)|1.32||||0.5467|TWO_SIDED|95.0|0.53|3.29|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||3.29|0.53|0.5467
74035424|NCT02190747|147623672|OTHER||Least square (LS) mean|-86.35|STANDARD_ERROR_OF_MEAN|220.57||0.6984|TWO_SIDED||||||Pairwise test|||Week 6: Analysis of area of new HO||||0.6984
74035425|NCT02190747|147623672|OTHER||LS mean|-38.07|STANDARD_ERROR_OF_MEAN|252.192||0.8811|TWO_SIDED||||||Pairwise test|||Week 6: Analysis of area of new HO||||0.8811
74035426|NCT02190747|147623672|OTHER||LS mean|-764.38|STANDARD_ERROR_OF_MEAN|220.57||0.0017|TWO_SIDED||||||Pairwise test|||Week 12: Analysis of area of new HO||||0.0017
74035427|NCT02190747|147623672|OTHER||LS mean|-703.43|STANDARD_ERROR_OF_MEAN|252.192||0.0094|TWO_SIDED||||||Pairwise test|||Week 12: Analysis of area of new HO||||0.0094
74035428|NCT02190747|147623673|OTHER|||||||0.1503|||||||Cochran-Armitage test of trend|||Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.1503
73876358|NCT01794000|147294745|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.83||||0.117|TWO_SIDED|95.0|0.66|1.05|||Andersen-Gill model||The rate ratio and 2-sided 95% Confidence Interval (CI) were estimated from the Andersen-Gill model.|The time to a recurrent episode of VOC was analyzed using Andersen-Gill model. A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.||1.05|0.66|.117
73876359|NCT01794000|147294746|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.242||||0.912|TWO_SIDED|95.0|-4.564|4.079||Mixed Model Repeated Measures (MMRM) included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square (LS) Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||4.079|-4.564|.912
73876360|NCT01794000|147294747|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.0968||||0.365|TWO_SIDED|95.0|-0.1132|0.3068||MMRM model included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||0.3068|-0.1132|.365
73876361|NCT01794000|147294748|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.82||||0.109|TWO_SIDED|95.0|0.65|1.04||The time to a recurrent episode of painful crisis was analyzed using Andersen-Gill model.|Andersen-Gill Model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.04|0.65|.109
73876362|NCT01794000|147294749|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.94||||0.759|TWO_SIDED|95.0|0.65|1.37||The time to a recurrent episode of hospitalization was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.37|0.65|.759
73876363|NCT01794000|147294750|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.96||||0.916|TWO_SIDED|95.0|0.48|1.93||The time to a recurrent episode of acute chest syndrome was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.93|0.48|.916
73991659|NCT04750577|147529378|OTHER||Odds Ratio (OR)|4.46||||0.0005|TWO_SIDED|95.0|1.91|10.39|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||10.39|1.91|0.0005
73991660|NCT04599907|147529392|SUPERIORITY||||||<|0.05|||||||Cochran-Mantel-Haenszel|||||||<0.05
73991661|NCT04599907|147529393|SUPERIORITY||Mean Difference (Final Values)|-0.91|||<|0.05|TWO_SIDED|95.0|-1.42|-0.04|||Mixed Models Analysis|||"This is the data for the Level of Botherstatistical analysis"||-0.040|-1.42|<0.05
73876364|NCT01794000|147294751|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|1.17||||0.544|TWO_SIDED|95.0|0.71|1.91||The time to a recurrent episode of RBC transfusion was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.91|0.71|.544
73991662|NCT04599907|147529393|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.05|TWO_SIDED|95.0|-1.35|-0.4|||Mixed Models Analysis|||"This is the data for the Level of Impact on Daily Activities Statistical Analysis"||-0.40|-1.35|<0.05
73991663|NCT03733899|147529439|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|4.96|||TWO_SIDED|95.0|-7.3|12.4|||Linear Mixed Model||Difference was calculated as Test - Placebo|5-Mintues Post Treatment||12.4|-7.3|
73991664|NCT03733899|147529439|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-9.6|11.5|||Linear Mixed Model||Difference was calculated as Test - Placebo|10-Minutes Post Treatment||11.5|-9.6|
73876365|NCT01794000|147294752|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.513||||0.602|TWO_SIDED|95.0|-4.186|7.213||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||7.213|-4.186|.602
73991665|NCT03733899|147529439|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-8.2|9.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|5-Minutes Post Treatment||9.8|-8.2|
73991666|NCT03733899|147529439|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-6.5|12.2|||Linear Mixed Model||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment||12.2|-6.5|
74035429|NCT04124536|147623707|SUPERIORITY||Risk Difference (RD)|-21.9|||||TWO_SIDED|95.0|-35.9|-7.9|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||-7.9|-35.9|
74035430|NCT04124536|147623707|SUPERIORITY||Risk Difference (RD)|-30.7|||||TWO_SIDED|95.0|-40.6|-20.8|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||-20.8|-40.6|
74035431|NCT04124536|147623708|SUPERIORITY||Risk Difference (RD)|-5.4|||||TWO_SIDED|95.0|-13.6|2.8|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||2.8|-13.6|
74035432|NCT04124536|147623708|SUPERIORITY||||||||||||||||||The calculation of risk differences between study arms was originally planned. However, the linear-binomial model did not converge because of zero events in the intervention arm.|||
73876366|NCT01794000|147294753|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.272||||0.459|TWO_SIDED|95.0|-2.109|4.652||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||4.652|-2.109|.459
73876367|NCT01794000|147294755|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.94||||0.662|TWO_SIDED|95.0|-3.31|5.19||The ANCOVA model included the factors of treatment, hydroxyurea use, age group, and length of follow-up.|ANCOVA||The LS Mean difference of prasugrel minus placebo and 2-sided 95% CI were estimated from the ANCOVA model.|||5.19|-3.31|.662
73876368|NCT01794000|147294756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.317|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the First VOC||||.317
73876369|NCT01794000|147294756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.133|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the Second VOC||||.133
73991667|NCT03733899|147529439|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|4.37|||TWO_SIDED|95.0|-5.7|11.7|||Linear Mixed Model||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment||11.7|-5.7|
73991668|NCT03733899|147529439|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.7|STANDARD_ERROR_OF_MEAN|4.54|||TWO_SIDED|95.0|-1.4|16.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|10-Mintues Post Treatment||16.8|-1.4|
73991669|NCT03733899|147529440|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|6.22|||TWO_SIDED|95.0|-10.3|14.4|||Linear Mixed Model||Difference was calculated as Test - Placebo|5-Mintues Post Treatment||14.4|-10.3|
73991670|NCT03733899|147529440|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-12.1|12.9|||Linear Mixed Model||Difference was calculated as Test - Placebo|10-Minutes Post Treatment||12.9|-12.1|
73991671|NCT03733899|147529440|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-11.4|12.1|||Linear Mixed Model||difference was calculated as Test - Placebo.|5-Minutes Post Treatment||12.1|-11.4|
73991672|NCT03733899|147529440|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-9.2|14.0|||Linear Mixed Model||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment||14.0|-9.2|
73991673|NCT03733899|147529440|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-8.5|14.3|||Linear Mixed Model||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment||14.3|-8.5|
73991674|NCT03733899|147529440|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.67|||TWO_SIDED|95.0|-3.7|18.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|10-Mintues Post Treatment||18.8|-3.7|
73991675|NCT03733899|147529441|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|4.61|||TWO_SIDED|95.0|-13.2|5.1|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|5.1|-13.2|
73876370|NCT01794000|147294757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.638|||||||Fisher Exact|||||||.638
73991676|NCT03733899|147529441|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|4.85|||TWO_SIDED|95.0|-13.9|5.3|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|5.3|-13.9|
73991677|NCT03733899|147529441|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|4.04|||TWO_SIDED|95.0|-24.4|-8.3|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|-8.3|-24.4|
73991678|NCT03733899|147529441|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|4.14|||TWO_SIDED|95.0|-17.8|-1.4|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|-1.4|-17.8|
73876371|NCT02920892|147294779|SUPERIORITY||Slope|-0.1||||0.1587|TWO_SIDED|90.0|-0.22|0.02|||Mixed Models Analysis|||||0.02|-0.22|0.1587
73876372|NCT02920892|147294780|SUPERIORITY||Slope|-1.66||||0.1054|TWO_SIDED|90.0|-3.34|0.03|||Mixed Models Analysis|||||0.03|-3.34|0.1054
73876373|NCT02920892|147294781|SUPERIORITY||Slope|-0.67||||0.32|TWO_SIDED|90.0|-1.79|0.45|||Mixed Models Analysis|||||0.45|-1.79|0.32
73991679|NCT03733899|147529441|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|4.15|||TWO_SIDED|95.0|-20.6|-4.1|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|-4.1|-20.6|
73991680|NCT03733899|147529441|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|4.25|||TWO_SIDED|95.0|-16.7|0.2|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|0.2|-16.7|
73991681|NCT03733899|147529442|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|5.07|||TWO_SIDED|95.0|-8.7|11.6|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin|11.6|-8.7|
73991682|NCT03733899|147529442|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-1.0|18.0|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin|18.0|-1.0|
73991683|NCT03733899|147529442|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-3.5|17.0|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin|17.0|-3.5|
73991684|NCT03733899|147529442|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|11.2|STANDARD_ERROR_OF_MEAN|4.82|||TWO_SIDED|95.0|1.6|20.8|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin|20.8|1.6|
73991685|NCT03733899|147529443|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|6.12|||TWO_SIDED|95.0|-11.4|12.9|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 10-mintues post treatment - Pre Treatment.|12.9|-11.4|
73991686|NCT03733899|147529443|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-4.9|19.9|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 5-mintues post treatment - Pre Treatment.|19.9|-4.9|
73991687|NCT03733899|147529443|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|6.19|||TWO_SIDED|95.0|-9.3|15.2|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 10-mintues post treatment - Pre Treatment.|15.2|-9.3|
74089999|NCT02508259|147733018|EQUIVALENCE|In this analysis, overall ASD symptom scores, measured by CGI were compared between suramin and placebo groups.|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|1.04||0.05|TWO_SIDED|95.0|-3.4|-0.15|||ANOVA|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.15|-3.4|0.05
74090000|NCT02508259|147733019|EQUIVALENCE|In this analysis, the child-specific RBQ score was tested for equivalence before and 6-weeks after suramin treatment.|Mean Difference (Net)|-3.2|STANDARD_DEVIATION|5.8||0.28|TWO_SIDED|95.0|-10.4|4.0|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||4.0|-10.4|0.28
73876374|NCT02920892|147294782|SUPERIORITY||Slope|-0.29||||0.78|TWO_SIDED|90.0|-1.98|1.4|||Mixed Models Analysis|||||1.4|-1.98|0.78
73991688|NCT03733899|147529443|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|6.17|||TWO_SIDED|95.0|-4.9|19.6|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 5-mintues post treatment - Pre Treatment.|19.6|-4.9|
73991689|NCT03733899|147529444|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|-12.4|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-20.9|-3.9|||Mixed Models Analysis||||mean difference was calculated as postremoval minus pre-insertion with Test and corneal region.|-3.9|-20.9|
73991690|NCT01641653|147529457|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This is a pilot study no power calculation was performed. The Wilcoxon rank-sum test was used to assess differences in max intraop glucose between placebo and midazolam groups.||||0.87
73991691|NCT01641653|147529458|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||percent change in glucose levels from preoperative level to maximum perioperative measurement level||||0.56
73991692|NCT01641653|147529459|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|||||Chi-square with continuity correction|Chi-squared, Corrected|||||||0.12
73991693|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS X axis||||0.098
73991694|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.389|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS Y axis||||0.389
73991695|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS Z axis||||0.780
73991696|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point X axis||||0.054
73876375|NCT02920892|147294783|SUPERIORITY||Slope|0.1||||0.94|TWO_SIDED|90.0|-2.05|2.24|||Mixed Models Analysis|||||2.24|-2.05|0.94
73991697|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point Y axis||||0.323
73876376|NCT02920892|147294784|SUPERIORITY||Slope|-0.85||||0.1428|TWO_SIDED|90.0|-1.81|0.11|||Mixed Models Analysis|||||0.11|-1.81|0.1428
73876377|NCT02920892|147294785|SUPERIORITY||Odds Ratio (OR)|0.9462||||0.24|TWO_SIDED|90.0|0.8764|1.0215|||Mixed Models Analysis|||||1.0215|0.8764|0.24
73876378|NCT02920892|147294786|SUPERIORITY||Odds Ratio (OR)|0.95||||0.92|TWO_SIDED|90.0|0.4|2.27|||Mixed Models Analysis|||||2.27|0.4|0.92
73876379|NCT00721396|147294794|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence interval of the difference in the percentage of subjects with hSBA titer ≥1:5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against 44/76-SL strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||1|-1|
73876380|NCT00721396|147294794|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference %(B+R246 minus B246_R357)|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against 5/99 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||1|-1|
73876381|NCT00721396|147294794|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|-8.0|||||TWO_SIDED|95.0|-12.0|-4.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against NZ98/254 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||-4|-12|
74035433|NCT04124536|147623712|SUPERIORITY||Risk Difference (RD)|40.7|||||TWO_SIDED|95.0|23.0|58.4|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||58.4|23.0|
73876382|NCT00721396|147294795|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for diphtheria (≥0.1 IU/mL) was \>-10%.|Difference %(B+R234 minus R234)|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Diphtheria antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-1|
73876383|NCT00721396|147294795|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for tetanus toxoid (≥0.1 IU/mL) was \>-10%.|Difference %(B+R234 minus R234)|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|||Non-inferiority of immune response to Tetanus antigens when routine vaccines are administered concomitantly with rMen+OMV NZ vaccine.||2|-1|
73876384|NCT00721396|147294800|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||TWO_SIDED|95.0|-5.0|4.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen FHA when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||4|-5|
73876385|NCT00721396|147294800|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-2.0|||||TWO_SIDED|95.0|-7.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen pertactin antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-7|
73876386|NCT00721396|147294800|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen PT when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-4|
73876387|NCT03546621|147294801|SUPERIORITY||||||<|0.0001|||||||Bonferroni-Holm|||For each of the three Myrcludex B treatment groups, a null hypothesis of no clinically significant difference in proportion of responders compared to the control group (Tenofovir only), at week 24, were tested using the one-sided Wald test for superiority, at a one-sided overall significance level of 0.05 adjusted for multiple testing according to Bonferroni-Holm, with the superiority limit (test margin) set to 5%.||||<.0001
73876388|NCT03546621|147294802|SUPERIORITY|||||||0.9818||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||0.9818
74035434|NCT04124536|147623712|SUPERIORITY||Risk Difference (RD)|23.3|||||TWO_SIDED|95.0|10.7|36.0|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||36.0|10.7|
74090001|NCT00518622|147733021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.01||||||95.0|-2.87|-1.14|||||Mean (Day 8 - baseline) HCV RNA for MK7009 25 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.14|-2.87|
74090002|NCT00518622|147733021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.64||||||95.0|-3.49|-1.8|||||Mean (Day 8 - baseline) HCV RNA for MK7009 75 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.80|-3.49|
73876389|NCT03546621|147294802|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value as smaller than 0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||1.0000
73876390|NCT03546621|147294802|SUPERIORITY|||||||0.7132||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||0.7132
73876391|NCT03546621|147294803|SUPERIORITY|||||||0.0232||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.~This analysis, and presentation of descriptive statistics, was repeated for the subgroups of patients with normal/abnormal baseline ALT values."||||0.0232
73991698|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point X axis||||0.371
73991699|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level X axis||||0.011
73991700|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.426|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level Y axis||||0.426
73991701|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.621|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level Z axis||||0.621
73991702|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.275|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale X axis||||0.275
74090003|NCT00518622|147733021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||||95.0|-3.9|-1.9|||||Mean (Day 8 - baseline) HCV RNA for MK7009 250 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.90|-3.90|
73876392|NCT03546621|147294803|SUPERIORITY|||||||0.0047||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.||||0.0047
73991703|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.361|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale Y axis||||0.361
73991704|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale Z axis||||0.284
73991705|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale X axis||||0.119
73991706|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale Y axis||||0.019
73991707|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale Z axis||||0.034
73991708|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious X axis||||0.422
73991709|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious Y axis||||0.177
73991710|NCT01473745|147529464|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious Z axis||||0.133
73991711|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Intercanthal distance||||0.218
73991712|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.336|TWO_SIDED||||||t-test, 2 sided|P- value \< 0.05 was set as statistical significance.||nasal height||||0.336
73991713|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||t-test, 2 sided|P- value \< 0.05 was set as statistical significance||||||0.192
73991714|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.135|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||nasal tip protrusion||||0.135
74090004|NCT00518622|147733021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.38||||||95.0|-4.59|-2.17|||||Mean (Day 8 - baseline) HCV RNA for MK7009 500 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-2.17|-4.59|
74090005|NCT00518622|147733021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.73||||||95.0|-5.15|-4.31|||||Mean (Day 8 - baseline) HCV RNA for MK7009 700 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-4.31|-5.15|
74090006|NCT00518622|147733021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.93||||||95.0|-2.68|-1.18|||||Mean (Day 8 - baseline) HCV RNA for MK7009 125 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.18|-2.68|
73991715|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||nasal width||||0.277
73991716|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.505|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.505
73991717|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.299
73991718|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.738
73991719|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.008
73991720|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.116|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneious height of upper lip||||0.116
73991721|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.528|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.528
73876393|NCT03546621|147294803|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.||||0.0010
74035435|NCT01496430|147623740|SUPERIORITY_OR_OTHER|||||||0.007||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.007
74035436|NCT01496430|147623740|SUPERIORITY_OR_OTHER|||||||0.067||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.067
74035437|NCT01496430|147623741|SUPERIORITY_OR_OTHER|||||||0.86||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.860
74035438|NCT01496430|147623741|SUPERIORITY_OR_OTHER|||||||0.21||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.210
74035439|NCT02512068|147623769|SUPERIORITY||Least square (LS) mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001|TWO_SIDED|95.0|-0.966|-0.473|||ANCOVA|||||-0.473|-0.966|<0.0001
74035440|NCT02512068|147623772|OTHER||Point estimate|-0.28|||||TWO_SIDED|95.0|-0.385|-0.18||||||Change from baseline in HbA1c at Week 2 was compared between the treatment groups.||-0.180|-0.385|
73991722|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.123
73991723|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.250
74035441|NCT02512068|147623772|OTHER||Point estimate|-0.48|||||TWO_SIDED|95.0|-0.621|-0.338||||||Change from baseline in HbA1c at Week 4 was compared between the treatment groups.||-0.338|-0.621|
74035442|NCT02512068|147623772|OTHER||Point estimate|-0.58|||||TWO_SIDED|95.0|-0.797|-0.367||||||Change from baseline in HbA1c at Week 8 was compared between the treatment groups.||-0.367|-0.797|
74035443|NCT02512068|147623772|OTHER||Point estimate|-0.71|||||TWO_SIDED|95.0|-0.975|-0.441||||||Change from baseline in HbA1c at Week 12 was compared between the treatment groups.||-0.441|-0.975|
74035444|NCT02512068|147623772|OTHER||Point estimate|-0.7|||||TWO_SIDED|95.0|-0.948|-0.452||||||Change from baseline in HbA1c at End of Treatment Period I was compared between the treatment groups.||-0.452|-0.948|
74035445|NCT02512068|147623773|OTHER||Point estimate|1.7|||||TWO_SIDED|95.0|-6.598|9.919||||||The data of participants achieving \<6.0% at the end of Treatment Period I were compared between the treatment groups.||9.919|-6.598|
74035446|NCT02512068|147623773|OTHER||Point estimate|32.9|||||TWO_SIDED|95.0|14.194|51.66||||||The data of participants achieving \<7.0% at the end of Treatment Period I were compared between the treatment groups.||51.660|14.194|
74035447|NCT02512068|147623773|OTHER||Point estimate|45.6|||||TWO_SIDED|95.0|15.528|75.7||||||The data of participants achieving \<8.0% at the end of Treatment Period I were compared between the treatment groups.||75.700|15.528|
74035448|NCT02512068|147623774|OTHER||Point estimate|-15.2|||||TWO_SIDED|95.0|-23.59|-6.88||||||Change from baseline in fasting plasma glucose at Week 2 was compared between the treatment groups.||-6.88|-23.59|
74035449|NCT02512068|147623774|OTHER||Point estimate|-8.7|||||TWO_SIDED|95.0|-20.98|3.58||||||Change from baseline in fasting plasma glucose at Week 4 was compared between the treatment groups.||3.58|-20.98|
74035450|NCT02512068|147623774|OTHER||Point estimate|-8.3|||||TWO_SIDED|95.0|-18.76|2.11||||||Change from baseline in fasting plasma glucose at Week 8 was compared between the treatment groups.||2.11|-18.76|
74035451|NCT02512068|147623774|OTHER||Point estimate|-15.6|||||TWO_SIDED|95.0|-27.14|-4.03||||||Change from baseline in fasting plasma glucose at Week 12 was compared between the treatment groups.||-4.03|-27.14|
74035452|NCT02512068|147623774|OTHER||Point estimate|-15.6|||||TWO_SIDED|95.0|-26.67|-4.62||||||Change from baseline in fasting plasma glucose at End of Treatment Period I was compared between the treatment groups.||-4.62|-26.67|
74035453|NCT02512068|147623775|OTHER||Point estimate|-1.76|||||TWO_SIDED|95.0|-2.184|-1.34||||||Change from baseline in glycoalbumin at Week 2 was compared between the treatment groups.||-1.340|-2.184|
73991724|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.706
73991725|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.804|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||intercanthal distance||||0.804
73991726|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.114|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal height||||0.114
73991727|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.457|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Nasal length||||0.457
73991728|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.565|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Nasal tip protrusion||||0.565
73991729|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.781|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal width||||0.781
73991730|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.164
73991731|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.554
73991732|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.508|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.508
73991733|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.358
73991734|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneous height of upper lip||||0.049
73991735|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.057
73876394|NCT03546621|147294804|SUPERIORITY|||||||0.1642||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to week 24 and week 48 in ALT levels was performed using van Elteren tests.~Fisher's exact test was used to test a null hypothesis of no difference in proportions (of patients with normal ALT values) against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computed using the Bonferroni-Holm method."||||0.1642
73876395|NCT03546621|147294804|SUPERIORITY|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24||||0.0428
73991736|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.062
73991737|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.029
73991738|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.011
73991739|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.211|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||intercanthal distance||||0.211
73991740|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal height||||0.102
73991741|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.136|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal length||||0.136
73991742|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal tip protrusion||||0.113
73991743|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal width||||0.115
73991744|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.535|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.535
73991745|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.850
73991746|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.891|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.891
73876396|NCT03546621|147294804|SUPERIORITY|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24||||0.0428
73991747|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.262|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.262
73991748|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.344|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneous height of upper lip||||0.344
73991749|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.057
73991750|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.995|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.995
73991751|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.440
73991752|NCT01473745|147529465|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.078
73991753|NCT01473745|147529466|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED|||||intergroup difference of conventional group|t-test, 2 sided|P value \< 0.05 was set as statistical significance.||||||0.104
73991754|NCT01473745|147529466|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||Intergroup difference of modified group|t-test, 2 sided|P value \<0.05 was set as statistical significance.||||||0.043
73991755|NCT01473745|147529466|SUPERIORITY_OR_OTHER|||||||0.888|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||||||0.888
73991756|NCT00158197|147529470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98|||<|0.01|TWO_SIDED||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
73991757|NCT00158197|147529470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
73991758|NCT00158197|147529470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
73991759|NCT00158197|147529471|SUPERIORITY_OR_OTHER|||||||0.02||||||Yes, the a priori plan to handle post hoc multiple comparisons was to use the method of Bonferroni adjustment. Thus, the new alpha level for these comparisons was \<0.0125.|ANOVA|||||||0.02
73991760|NCT00158197|147529471|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73991761|NCT00158197|147529471|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73991762|NCT00158197|147529471|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
73991763|NCT00158197|147529472|SUPERIORITY_OR_OTHER|||||||0.78|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.78
73991764|NCT00158197|147529472|SUPERIORITY_OR_OTHER|||||||0.68|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.68
73991765|NCT00158197|147529472|SUPERIORITY_OR_OTHER|||||||0.2|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.20
74009231|NCT01380730|147569257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.44|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-43.39|-33.48||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-33.48|-43.39|<0.001
73876397|NCT03546621|147294804|SUPERIORITY|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Boferroni-Holm|||Week 48||||0.2388
74090007|NCT00518622|147733021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.46||||||95.0|-2.78|-2.13|||||Mean (Day 8 - baseline) HCV RNA for MK7009 600 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo|||-2.13|-2.78|
73876398|NCT03546621|147294804|SUPERIORITY|||||||0.7157||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.7157
73991766|NCT03121820|147529484|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|93.8||||0.05|TWO_SIDED|90.0|88.25|99.77|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg||99.77|88.25|0.05
73991767|NCT03121820|147529485|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|92.3||||0.05|TWO_SIDED|90.0|86.37|98.55|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg||98.55|86.37|0.05
73991768|NCT04836559|147529486|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.3571|TWO_SIDED|95.0|0.41|1.38|||t-test, 1 sided|||||1.38|0.41|0.3571
73991769|NCT04836559|147529486|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.6306|TWO_SIDED|95.0|0.4|1.75|||t-test, 1 sided|||||1.75|0.40|0.6306
73991770|NCT00730015|147529508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.72|||<|0.0001|TWO_SIDED|95.0|3.41|17.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be at least 90% based on study NCT00402337(MCP-103-201) data.||17.47|3.41|<0.0001
73991771|NCT00730015|147529508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.21|||<|0.0001|TWO_SIDED|95.0|3.14|16.59||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be greater than 96% based on study NCT00402337(MCP-103-201) data.||16.59|3.14|<0.0001
73991772|NCT00013611|147529519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.47|TWO_SIDED|95.0|0.7|1.18|||Regression, Cox|Stratification by CD4+ count stratum (50-199 or 200-299) and country of randomization.||Null hypothesis was that event rates in two groups are equal. Study was designed with 80%, two-sided alpha=.05, assuming a 28% reduction in the hazard of opportunistic disease or death.||1.18|0.70|0.47
73991773|NCT00013611|147529520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.73|TWO_SIDED|95.0|0.77|1.44|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.||||1.44|0.77|0.73
73991774|NCT00013611|147529521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1|TWO_SIDED|95.0|0.51|1.06|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.||||1.06|0.51|0.10
73991775|NCT00013611|147529522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.35|TWO_SIDED|95.0|0.9|1.34|||Regression, Cox|||||1.34|0.90|0.35
73991776|NCT00013611|147529523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.0|STANDARD_ERROR_OF_MEAN|6.5|<|0.001|TWO_SIDED|95.0|40.3|65.7|||Mixed Models Analysis|||||65.7|40.3|< 0.001
73991777|NCT01150045|147529525|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.12|TWO_SIDED|95.0|0.76|1.03|||Log Rank|||||1.03|0.76|0.12
73991778|NCT01663506|147529534|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 3||||<0.01
73991779|NCT01663506|147529534|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
73991780|NCT01663506|147529534|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
73991781|NCT01663506|147529536|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.001
73991782|NCT01663506|147529536|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.0001
74090008|NCT03821272|147733024|SUPERIORITY||non-recurrence rate|0.45||||0.31|TWO_SIDED|95.0|0.17|0.77|||Fisher Exact|||||0.77|0.17|0.31
74090009|NCT03821272|147733025|SUPERIORITY||non-recurrence rate|0.8||||0.31|TWO_SIDED|95.0|0.28|0.99|||Fisher Exact|||||0.99|0.28|0.31
74090010|NCT03821272|147733026|SUPERIORITY||non-recurrence rate|0.56||||0.58|TWO_SIDED|95.0|0.21|0.86|||Fisher Exact|||||0.86|0.21|0.58
74090011|NCT03821272|147733027|SUPERIORITY||non-recurrence rate|0.8||||0.58|TWO_SIDED|95.0|0.28|0.99|||Fisher Exact|||||0.99|0.28|0.58
74090012|NCT02960893|147733033|SUPERIORITY||LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.519|TWO_SIDED|95.0|-0.5|0.9||Significance was evaluated at a 2-sided alpha level of 0.05|Mixed Model with Repeated Measures|Fixed effects: treatment, baseline (BL) gait severity, visit, treatment-by-visit interaction; Covariate: BL Total SARA score; Random effect: subject||||0.9|-0.5|0.519
73991783|NCT01663506|147529537|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
73991784|NCT01663506|147529537|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.0001
73991785|NCT01663506|147529539|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
73991786|NCT01663506|147529539|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
73991787|NCT01663506|147529540|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
73876399|NCT03546621|147294804|SUPERIORITY|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.2388
73876400|NCT03546621|147294805|SUPERIORITY|||||||0.7416||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni-Holm method."||||0.7416
73876401|NCT03546621|147294805|SUPERIORITY|||||||0.4434||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.4434
73876402|NCT03546621|147294805|SUPERIORITY|||||||0.7371||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24.||||0.7371
73876403|NCT03546621|147294805|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
73876404|NCT03546621|147294805|SUPERIORITY|||||||0.9441||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.9441
73876405|NCT03546621|147294805|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
73876406|NCT03546621|147294806|SUPERIORITY||Bonferroni-Holm|||||0.5984||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to Week 24 in HBsAg was performed using van Elteren tests. Tests were performed on log-10 transformed data.~Separare comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted values were computed using the Bonferroni-Holm method."||||0.5984
73991788|NCT01663506|147529542|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.001
73991789|NCT01663506|147529542|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
73991790|NCT01663506|147529543|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
73876407|NCT03546621|147294806|SUPERIORITY|||||||0.7529||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.7529
73876408|NCT03546621|147294806|SUPERIORITY|||||||0.3305||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.3305
73876409|NCT03546621|147294806|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
73991791|NCT01663506|147529543|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
73991792|NCT01663506|147529545|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 6||||<0.01
73876410|NCT03546621|147294806|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
73876411|NCT03546621|147294806|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
73876412|NCT03546621|147294807|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Tests were performed on log-10 transformed data. Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni-Holm method."||||1.0000
73876413|NCT03546621|147294807|SUPERIORITY|||||||1|||||||Bonferroni-Holm|||Week 24.||||1.0000
73876414|NCT03546621|147294807|SUPERIORITY|||||||1|||||||Bonferroni-Holm|||Week 24||||1.0000
73876415|NCT03546621|147294807|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 48||||1.0000
73876416|NCT03546621|147294807|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
73876417|NCT03546621|147294807|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
73876418|NCT02365649|147294814|SUPERIORITY||Adjusted risk difference from placebo|9.9||||0.056|TWO_SIDED|95.0|-0.3|20.1||Statistical significance was prespecified at α = 0.1. Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||20.1|-0.3|0.056
73876419|NCT02365649|147294814|SUPERIORITY||Adjusted risk difference from placebo|7.4||||0.108|TWO_SIDED|95.0|-1.6|16.4||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.4|-1.6|0.108
73876420|NCT02365649|147294814|SUPERIORITY||Adjusted risk difference from placebo|7.7||||0.099|TWO_SIDED|95.0|-1.5|16.8||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.8|-1.5|0.099
73991793|NCT01663506|147529545|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 6||||<0.01
73991794|NCT01663506|147529545|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 12||||<0.001
73991795|NCT01663506|147529545|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 12||||<0.01
73991796|NCT01663506|147529546|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
73991797|NCT01663506|147529546|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.001
73991798|NCT01663506|147529547|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
73991799|NCT01663506|147529547|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.001
73876421|NCT02365649|147294814|SUPERIORITY||Adjusted risk difference from placebo|21.0||||0.004|TWO_SIDED|95.0|6.8|35.2||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||35.2|6.8|0.004
73991800|NCT02431052|147529554|OTHER|||||||0.0006|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.||||||0.0006
73991801|NCT02431052|147529555|OTHER|||||||0.0002|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.||||||0.0002
73991802|NCT02431052|147529556|OTHER|||||||0.0055|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (vehicle treatment groups included as single combined treatment group).||||||0.0055
73991803|NCT02094898|147529557|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
73876422|NCT02365649|147294814|SUPERIORITY||Adjusted risk difference from placebo|13.6||||0.025|TWO_SIDED|95.0|1.8|25.5||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||25.5|1.8|0.025
73991804|NCT02094898|147529557|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.05
73991805|NCT02094898|147529558|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
73991806|NCT02094898|147529559|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
73991807|NCT02094898|147529559|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
73991808|NCT02094898|147529559|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
73991809|NCT02094898|147529560|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
73991810|NCT02094898|147529561|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
73991811|NCT02094898|147529561|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
73991812|NCT02094898|147529562|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
73991813|NCT02094898|147529563|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
73991814|NCT02094898|147529563|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
73991815|NCT02094898|147529564|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
73991816|NCT02094898|147529565|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
73991817|NCT02094898|147529565|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
73876423|NCT02365649|147294815|SUPERIORITY||Adjusted risk difference from placebo|2.5||||0.74|TWO_SIDED|95.0|-12.3|17.3||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||17.3|-12.3|0.74
73876424|NCT02365649|147294815|SUPERIORITY||Adjusted risk difference from placebo|16.2||||0.082|TWO_SIDED|95.0|-2.0|34.3||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.3|-2.0|0.082
73991818|NCT02094898|147529566|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
73991819|NCT02094898|147529567|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.05
73991820|NCT02094898|147529567|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
73991821|NCT02094898|147529568|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
73991822|NCT02094898|147529569|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
73991823|NCT02094898|147529569|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
73991824|NCT01234883|147529575|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73991825|NCT00476242|147529589|SUPERIORITY_OR_OTHER|||||||0.047|||||||Log Rank|||||||.047
73991826|NCT02270671|147529591|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \>.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
73991827|NCT02270671|147529592|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: =.026|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
73991828|NCT02270671|147529593|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \>.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
73991829|NCT02270671|147529594|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \<.0001|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
73991830|NCT02270671|147529595|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: =.007|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
73991831|NCT05878873|147529652|OTHER||Mean Difference (Net)|-0.078|STANDARD_ERROR_OF_MEAN|0.027||0.007|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44.|This estimate calculation is TENS ON - TENS OFF.|Statistical analysis comparing cortical activation between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.007
73991832|NCT05878873|147529652|OTHER||Mean Difference (Net)|-0.089|STANDARD_ERROR_OF_MEAN|0.032||0.008|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF.|Statistical analysis comparing cortical activation between TENS ON and TENS OFF conditions in healthy controls.||||0.008
73991833|NCT05878873|147529653|OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.0141||0.014|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|This estimate calculation is TENS ON - TENS OFF at Visit 2.|Statistical analysis comparing savings between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.014
74035454|NCT02512068|147623775|OTHER||Point estimate|-2.45||||||95.0|-3.03|-1.87||||||Change from baseline in glycoalbumin at Week 4 was compared between the treatment groups.||-1.870|-3.030|
73876425|NCT02365649|147294815|SUPERIORITY||Adjusted risk difference from placebo|0.5||||0.952|TWO_SIDED|95.0|-14.1|15.0||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.0|-14.1|0.952
73991834|NCT05878873|147529653|OTHER||Mean Difference (Net)|-0.0058|STANDARD_ERROR_OF_MEAN|0.167||0.878|TWO_SIDED|||||This value was corrected with false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF at Visit 2|Statistical analysis comparing savings between TENS ON and TENS OFF conditions in healthy controls.||||0.878
73991835|NCT05878873|147529654|OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.018||0.898|TWO_SIDED|||||This value was corrected using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF|Statistical analysis comparing rate of adaptation between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.898
74035455|NCT02512068|147623775|OTHER||Point estimate|-2.48|||||TWO_SIDED|95.0|-3.289|-1.679||||||Change from baseline in glycoalbumin at Week 8 was compared between the treatment groups.||-1.679|-3.289|
74035456|NCT02512068|147623775|OTHER||Point estimate|-2.66|||||TWO_SIDED|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at Week 12 was compared between the treatment groups.||-1.715|-3.608|
73991836|NCT05878873|147529654|OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.698|TWO_SIDED|||||This value was corrected using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF|Statistical analysis comparing rate of adaptation between TENS ON and TENS OFF conditions in healthy controls.||||0.698
73991837|NCT00882115|147529660|OTHER||||||<|0.001|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison was made to the 24 h minus baseline change in both control phase and intervention phase.||||<0.001
73991838|NCT00882115|147529660|OTHER||||||<|0.01|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison waws made to the 6 hour minus baseline change in both control phase and intervention phase.||||<0.01
73991839|NCT02552147|147529661|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||.44
73991840|NCT02552147|147529662|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.38
73991841|NCT02552147|147529666|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.13
73991842|NCT02552147|147529667|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.13
73991843|NCT02552147|147529668|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.50
73991844|NCT02552147|147529669|SUPERIORITY|||||||1||||||P value was calculated to \>0.99 and thus rounded to 1.0.|Wilcoxon (Mann-Whitney)|Two-tailed||||||1.0
73991845|NCT02552147|147529670|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.25
73991846|NCT02552147|147529671|SUPERIORITY|||||||0.69|||||||Binomial test|||||||0.69
73991847|NCT02229227|147529677|NON_INFERIORITY|If the upper bound of the confidence interval is less than or equal to 0.3%, non-inferiority will be concluded.|Mean Difference (Net)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.05|0.17||Non-inferiority p-value. P-value from testing the null hypothesis that the difference in change from baseline least squares means (albiglutide-insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance.|t-test, 2 sided||Least Square mean of albiglutide + insulin glargine from insulin lispro + insulin glargine has been presented.|||0.17|-0.05|<0.0001
74035457|NCT02512068|147623775|OTHER||Point estimate|-2.66|||||TWO_SIDED|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at End of Treatment Period I was compared between the treatment groups.||-1.715|-3.608|
74035458|NCT01962714|147623795|NON_INFERIORITY|The primary outcome of non-inferiority of LKM relative to CPT-C was assessed using a non-inferiority margin of 5 points on the CAPS-5, which represents 0.5 SD of baseline PTSD symptoms based on data indicating the SD of baseline CAPS-5 scores is approximately 10 in a large sample (N=198) of treatment-seeking veterans.|Mean Difference (Final Values)|2.09|||||TWO_SIDED|95.0|-2.59|6.78|||||Non-inferiority of LKM to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.||6.78|-2.59|
73876426|NCT02365649|147294815|SUPERIORITY||Adjusted risk difference from placebo|11.2||||0.205|TWO_SIDED|95.0|-6.1|28.5||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||28.5|-6.1|0.205
73991848|NCT02229227|147529679|OTHER||Odds Ratio (OR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.31|0.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||0.60|0.31|<0.0001
73991849|NCT02229227|147529680|SUPERIORITY||Mean Difference (Net)|-4.37|||<|0.0001|TWO_SIDED|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-3.82|-4.93|<0.0001
73991850|NCT02229227|147529681|OTHER||Mean Difference (Net)|-1.21|||||TWO_SIDED|95.0|-1.43|-1.0|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 4 has been presented.|Week 4||-1.00|-1.43|
73991851|NCT02229227|147529681|OTHER||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-2.05|-1.55|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 5 has been presented.|Week 5||-1.55|-2.05|
73991852|NCT02229227|147529681|OTHER||Mean Difference (Net)|-3.17|||||TWO_SIDED|95.0|-3.51|-2.82|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 10 has been presented.|Week 10||-2.82|-3.51|
73876427|NCT02365649|147294815|SUPERIORITY||Adjusted risk difference from placebo|4.1||||0.607|TWO_SIDED|95.0|-11.5|19.6||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||19.6|-11.5|0.607
73876428|NCT02365649|147294816|SUPERIORITY||Adjusted risk difference from placebo|5.2||||0.564|TWO_SIDED|95.0|-12.5|22.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.9|-12.5|0.564
73876429|NCT02365649|147294816|SUPERIORITY||Adjusted risk difference from placebo|12.0||||0.221|TWO_SIDED|95.0|-7.2|31.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||31.2|-7.2|0.221
73991853|NCT02229227|147529681|OTHER||Mean Difference (Net)|-4.01|||||TWO_SIDED|95.0|-4.48|-3.54|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 18 has been presented.|Week 18||-3.54|-4.48|
73991854|NCT02229227|147529681|OTHER||Mean Difference (Net)|-4.37|||<|0.0001|TWO_SIDED|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 26 has been presented.|Week 26||-3.82|-4.93|<0.0001
73991855|NCT02229227|147529682|SUPERIORITY||Mean Difference (Final Values)|-60.83|||<|0.0001|TWO_SIDED|95.0|-66.57|-55.1|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-55.10|-66.57|<0.0001
73991856|NCT02229227|147529683|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.12|||<|0.0001|TWO_SIDED|95.0|-0.18|-0.07|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-0.07|-0.18|<0.0001
73991857|NCT02229227|147529683|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.09|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.02|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||-0.02|-0.15|<0.0001
73991858|NCT02229227|147529683|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.08|||<|0.0001|TWO_SIDED|95.0|-0.01|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||0.17|-0.01|<0.0001
73991859|NCT02229227|147529683|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.11|||<|0.0001|TWO_SIDED|95.0|0.01|0.21|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||0.21|0.01|<0.0001
73991860|NCT02229227|147529683|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.05|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||0.17|-0.05|<0.0001
73991861|NCT02229227|147529684|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0004|TWO_SIDED|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-0.25|-0.86|0.0004
73991862|NCT02229227|147529685|OTHER||Mean Difference (Net)|-0.54|||||TWO_SIDED|95.0|-0.84|-0.24|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-0.24|-0.84|
73876430|NCT02365649|147294816|SUPERIORITY||Adjusted risk difference from placebo|22.2||||0.036|TWO_SIDED|95.0|1.4|43.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||43|1.4|0.036
73991863|NCT02229227|147529685|OTHER||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.51|0.13|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||0.13|-0.51|
73991864|NCT02229227|147529685|OTHER||Mean Difference (Net)|-0.53|||||TWO_SIDED|95.0|-0.85|-0.22|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-0.22|-0.85|
73991865|NCT02229227|147529685|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0004|TWO_SIDED|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||-0.25|-0.86|0.0004
73991866|NCT02229227|147529686|OTHER||Odds Ratio (OR)|0.96||||0.7026|TWO_SIDED|95.0|0.71|1.31||Non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||1.31|0.71|0.7026
73991867|NCT02229227|147529687|OTHER||Odds Ratio (OR)|1.17||||0.2883|TWO_SIDED|95.0|0.84|1.64||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4|Week 4||1.64|0.84|0.2883
73876431|NCT02365649|147294816|SUPERIORITY||Adjusted risk difference from placebo|13.4||||0.179|TWO_SIDED|95.0|-6.2|33.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.1|-6.2|0.179
73876432|NCT02365649|147294816|SUPERIORITY||Adjusted risk difference from placebo|3.9||||0.677|TWO_SIDED|95.0|-14.3|22.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22|-14.3|0.677
73876433|NCT02365649|147294817|SUPERIORITY||Adjusted risk difference from placebo|10.4||||0.363|TWO_SIDED|95.0|-12.0|32.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.9|-12|0.363
73876434|NCT02365649|147294817|SUPERIORITY||Adjusted risk difference from placebo|17.3||||0.137|TWO_SIDED|95.0|-5.5|40.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40|-5.5|0.137
73991868|NCT02229227|147529687|OTHER||Odds Ratio (OR)|0.82||||0.3034|TWO_SIDED|95.0|0.59|1.15||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||1.15|0.59|0.3034
73991869|NCT02229227|147529687|OTHER||Odds Ratio (OR)|0.71||||0.0151|TWO_SIDED|95.0|0.52|0.98||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||0.98|0.52|0.0151
73991870|NCT02229227|147529687|OTHER||Odds Ratio (OR)|0.75||||0.0518|TWO_SIDED|95.0|0.54|1.03||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||1.03|0.54|0.0518
73991871|NCT02229227|147529687|OTHER||Odds Ratio (OR)|0.96||||0.7026|TWO_SIDED|95.0|0.71|1.31||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||1.31|0.71|0.7026
73991872|NCT02229227|147529688|OTHER||Odds Ratio (OR)|0.85||||0.2298|TWO_SIDED|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||1.17|0.63|0.2298
73991873|NCT02229227|147529689|OTHER||Odds Ratio (OR)|1.32||||0.2143|TWO_SIDED|95.0|0.78|2.23||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||2.23|0.78|0.2143
73991874|NCT02229227|147529689|OTHER||Odds Ratio (OR)|1.24||||0.4703|TWO_SIDED|95.0|0.8|1.91||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||1.91|0.80|0.4703
73991875|NCT02229227|147529689|OTHER||Odds Ratio (OR)|0.81||||0.2139|TWO_SIDED|95.0|0.58|1.14||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||1.14|0.58|0.2139
73991876|NCT02229227|147529689|OTHER||Odds Ratio (OR)|0.81||||0.079|TWO_SIDED|95.0|0.59|1.11||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||1.11|0.59|0.0790
73991877|NCT02229227|147529689|OTHER||Odds Ratio (OR)|0.85||||0.2298|TWO_SIDED|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||1.17|0.63|0.2298
73991878|NCT02229227|147529690|OTHER||Odds Ratio (OR)|1.08||||0.8292|TWO_SIDED|95.0|0.24|4.77||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||4.77|0.24|0.8292
73991879|NCT02229227|147529692|OTHER||Mean Difference (Final Values)|-56.38|||||TWO_SIDED|95.0|-59.19|-53.57|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-53.57|-59.19|
73991880|NCT02229227|147529692|OTHER||Mean Difference (Final Values)|-63.7|||||TWO_SIDED|95.0|-67.78|-59.62|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||-59.62|-67.78|
73991881|NCT02229227|147529692|OTHER||Mean Difference (Final Values)|-62.0|||||TWO_SIDED|95.0|-67.29|-56.7|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-56.70|-67.29|
73991882|NCT02229227|147529693|SUPERIORITY||Mean Difference (Final Values)|-0.97|||||TWO_SIDED|95.0|-2.25|0.3|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||0.30|-2.25|
73991883|NCT02229227|147529693|OTHER||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.64|2.33|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||2.33|-1.64|
73991884|NCT02229227|147529693|OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-2.21|2.69|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||2.69|-2.21|
73991885|NCT02229227|147529693|OTHER||Mean Difference (Final Values)|0.39||||0.7699|TWO_SIDED|95.0|-2.25|3.04|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||3.04|-2.25|0.7699
73991886|NCT02229227|147529694|OTHER||Mean Difference (Final Values)|-56.05|||||TWO_SIDED|95.0|-58.17|-53.94|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-53.94|-58.17|
73991887|NCT02229227|147529694|OTHER||Mean Difference (Final Values)|-64.76|||||TWO_SIDED|95.0|-67.68|-61.85|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||-61.85|-67.68|
73991888|NCT02229227|147529694|OTHER||Mean Difference (Final Values)|-62.92|||||TWO_SIDED|95.0|-66.69|-59.15|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-59.15|-66.69|
73991889|NCT02229227|147529694|SUPERIORITY||Mean Difference (Final Values)|-61.83|||<|0.0001|TWO_SIDED|95.0|-65.85|-57.81|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|week 26||-57.81|-65.85|<0.0001
73991890|NCT02229227|147529696|OTHER||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.52|4.86||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||4.86|2.52|<0.0001
73991891|NCT02229227|147529697|OTHER||Odds Ratio (OR)|2.36|||<|0.0001|TWO_SIDED|95.0|1.54|3.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||3.60|1.54|<0.0001
73991892|NCT02229227|147529698|OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.21|6.48||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||6.48|2.21|<0.0001
74035459|NCT01962714|147623796|NON_INFERIORITY|For depression, the non-inferiority margin was 4 points on the PROMIS depression measure, which has been defined as the minimally important difference and corresponds to a Cohen's d effect size of approximately 0.50.|Mean Difference (Final Values)|2.34|||||TWO_SIDED|95.0|-0.52|5.2|||||Non-inferiority of LKM with respect to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores from baseline for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.||5.20|-0.52|
74035460|NCT01098461|147623797|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.57|||t-test, 2 sided|||||-0.57|-1.22|<0.0001
74035461|NCT01098461|147623797|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.55|||<|0.0001|TWO_SIDED|95.0|-1.88|-1.23|||t-test, 2 sided|||||-1.23|-1.88|<0.0001
74090013|NCT01013649|147733057|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.62|TWO_SIDED|95.0|0.79|1.38||One-sided significance level = 0.15|Log Rank||Reference level = Arm I|A total of 200 deaths between the arms will provide 80% power to detect a signal for an increase in median overall survival from 22 to 28.8 months and 90% power to detect a signal for an increase in median overall survival from 22 to 30.6 months (HRs of 0.76 and 0.72, respectively, in favor of the erlotinib arm) with the addition of erlotinib and a 1-sided alpha of 0.15||1.38|0.79|0.62
73991893|NCT04560374|147529762|EQUIVALENCE|Power analysis was performed after the completion of the study. 98% power was obtained.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74035462|NCT01098461|147623797|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.43|-0.78|||t-test, 2 sided|||||-0.78|-1.43|<0.0001
74035463|NCT03615469|147623806|OTHER|t-test||||||0.22|||||||t-test, 2 sided|||||||0.22
74035464|NCT01153763|147623807|OTHER||percentage of participants|59.0|||||TWO_SIDED|95.0|48.2|70.3|||||The estimated value represents the percentage of participants with a confirmed CR or a confirmed PR.|||70.3|48.2|
74035465|NCT01153763|147623808|OTHER||percentage of participants|13.0|||||TWO_SIDED|95.0|0.0|28.7|||||The estimated value represents the percentage of participants with a investigator assessed CR or PR.|||28.7|0.0|
73991894|NCT02489734|147529787|SUPERIORITY||Relative risk (RR)|3.4||||0.003|TWO_SIDED|95.0|1.4|8.1|||Chi-squared|||||8.1|1.4|0.003
73991895|NCT03721172|147529788|SUPERIORITY||Adjusted difference|17.5|||<|0.0001|TWO_SIDED|95.0|12.2|22.8|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||22.8|12.2|<0.0001
73991896|NCT03721172|147529789|SUPERIORITY||Adjusted difference|25.6|||<|0.0001|TWO_SIDED|95.0|19.1|32.1|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||32.1|19.1|<0.0001
74035466|NCT01153763|147623813|OTHER||percentage of participants|20.0|||||TWO_SIDED|95.0|11.6|29.8|||||The estimated value represents the percentage of participants with overall survival.|||29.8|11.6|
74035467|NCT01153763|147623814|OTHER||percentage of participants|13.0|||||TWO_SIDED|95.0|2.2|34.6|||||The estimated value represents the percentage of participants with overall survival.|||34.6|2.2|
74035468|NCT00369668|147623886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0|STANDARD_ERROR_OF_MEAN|3.65|<|0.05|TWO_SIDED|95.0|22.5|37.4|||Mixed Models Analysis|Greenhouse-Geisser degrees of freedom adjustment was not necessary.||Group by Test Session ANOVA with repeated measures on second factor.||37.4|22.5|<0.05
74035469|NCT01552928|147623904|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANCOVA|||||||0.004
74035470|NCT01552928|147623904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035471|NCT01552928|147623904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035472|NCT01552928|147623905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035473|NCT01552928|147623905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035474|NCT01552928|147623905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
74035475|NCT01552928|147623906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANCOVA|||||||0.012
74035476|NCT01552928|147623906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044|||||||ANCOVA|||||||0.044
74035477|NCT01552928|147623906|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035478|NCT01552928|147623907|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035479|NCT01552928|147623907|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
73991897|NCT03721172|147529790|SUPERIORITY||Least squares mean difference|-3.38|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-4.04|-2.73|||Mixed-effect model for repeated measures|||||-2.73|-4.04|<0.0001
73991898|NCT03721172|147529791|SUPERIORITY||Least squares mean difference|-2.93|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.47|-2.39|||Mixed-effect model for repeated measures|||||-2.39|-3.47|<0.0001
73991899|NCT03721172|147529792|SUPERIORITY||Adjusted difference|38.0|||<|0.0001|TWO_SIDED|95.0|29.7|46.3|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||46.3|29.7|<0.0001
73991900|NCT03721172|147529793|SUPERIORITY||Adjusted difference|24.7|||<|0.0001|TWO_SIDED|95.0|16.5|32.8|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||32.8|16.5|<0.0001
73991901|NCT03721172|147529794|SUPERIORITY||Adjusted difference|27.4|||<|0.0001|TWO_SIDED|95.0|18.6|36.3|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||36.3|18.6|<0.0001
73991902|NCT03721172|147529795|SUPERIORITY||Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.7|-2.1|||Mixed-effect model for repeated measures|||||-2.1|-3.7|<0.0001
73991903|NCT00420784|147529797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.23|||<|0.001|TWO_SIDED|95.0|4.14|16.36|||Regression, Logistic|||||16.36|4.14|<0.001
73991904|NCT00420784|147529797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.52|||<|0.001|TWO_SIDED|95.0|4.72|19.2|||Regression, Logistic|||||19.20|4.72|<0.001
73991905|NCT00420784|147529797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31||||0.024|TWO_SIDED|95.0|1.12|4.75|||Regression, Logistic|||||4.75|1.12|0.024
73991906|NCT00420784|147529799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.64|||<|0.001|TWO_SIDED|95.0|3.41|12.96|||Regression, Logistic|||||12.96|3.41|<0.001
73991907|NCT00420784|147529799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.72|||<|0.001|TWO_SIDED|95.0|2.91|11.27|||Regression, Logistic|||||11.27|2.91|<0.001
73991908|NCT00420784|147529799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.067|TWO_SIDED|95.0|0.95|4.0|||Regression, Logistic|||||4.00|0.95|0.067
73991909|NCT02402322|147529806|NON_INFERIORITY_OR_EQUIVALENCE|In the preliminary analysis, we studied the possible group differences in demographic data and pretreatment measures with chi-square tests and analysis of variance (ANOVA).||||||0.05|TWO_SIDED||||||ANOVA|||The participants' pre- and posttreatment scores were studied with repeated measures ANOVA. Within- and between-group effect sizes were calculated using the pooled standard deviation, Cohen's d.||||0.05
73991910|NCT04593823|147529815|SUPERIORITY||Win Ratio|1.11|||||TWO_SIDED|95.0|0.48|2.5|||||A win ratio parameter signifies the percentage of wins that a treatment group has achieved when compared against a comparator.|||2.50|0.48|
73991911|NCT04593823|147529816|SUPERIORITY||Mean Difference (Final Values)|2.9|||>|0.999|TWO_SIDED|95.0|-17.0|15.9|||Chi-squared|||||15.9|-17.0|>0.999
73991912|NCT04593823|147529817|SUPERIORITY||Median Difference (Final Values)|-8.8||||0.459|TWO_SIDED|95.0|-36.4|13.6|||Chi-squared|||||13.6|-36.4|0.459
73991913|NCT04593823|147529819|SUPERIORITY||Least Squares Mean Difference|8.887||||0.547|TWO_SIDED|95.0|-20.01|37.784|||ANOVA|Repeated measures analysis||||37.784|-20.010|0.547
73991914|NCT04593823|147529820|SUPERIORITY|||||||0.336|||||||Wilcoxon (Mann-Whitney)|||||||0.336
73991915|NCT02472145|147529831|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4747|TWO_SIDED|95.0|0.8|2.8|||Chi-squared|||Statistical Analysis 1||2.8|0.8|0.4747
73991916|NCT02472145|147529832|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7817|TWO_SIDED|95.0|0.79|1.37|||Log Rank|||Statistical Analysis 1||1.37|0.79|0.7817
73991917|NCT01586975|147529861|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED|||||p-value is not adjusted, and no a priori threshold was used|Kruskal-Wallis|||Kruskal-Wallis non-parametric ANOVA test||||0.0742
73991918|NCT00745498|147529882|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||With study power of 80%, a significance level of 0.05, and the assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated.||||<0.05
73991919|NCT02353312|147529909|EQUIVALENCE|Pairwise comparisons of VO2 max means with equal variances between participant on and off treatment.||||||0.823|||||||t-test, 2 sided|||||||0.823
73991920|NCT01527162|147529911|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
73991921|NCT01527162|147529912|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||= 0.14
73991922|NCT01527162|147529913|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon Sign Rank TEst||||>.54
73991923|NCT01527162|147529913|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||= 0.20
73991924|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.99|||||TWO_SIDED|95.0|0.65|1.52||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.52|0.65|
73991925|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|2.11|||||TWO_SIDED|95.0|1.5|2.98||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.98|1.5|
74009232|NCT01380730|147569257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.58|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-52.72|-42.44||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-42.44|-52.72|<0.001
73991926|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.68|||||TWO_SIDED|95.0|0.43|1.06||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||1.06|0.43|
73991927|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.87|0.58|
73991928|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.0|||||TWO_SIDED|95.0|0.92|1.08||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.08|0.92|
73991929|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.78|||||TWO_SIDED|95.0|0.6|1.01||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||1.01|0.6|
73991930|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.27|||||TWO_SIDED|95.0|0.83|1.96||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.96|0.83|
73991931|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|1.6|||||TWO_SIDED|95.0|1.13|2.28||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.28|1.13|
73991932|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.52|||||TWO_SIDED|95.0|0.33|0.81||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||0.81|0.33|
73991933|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||TWO_SIDED|95.0|0.52|0.78||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.78|0.52|
73991934|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.96|||||TWO_SIDED|95.0|0.89|1.04||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.04|0.89|
73991935|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||TWO_SIDED|95.0|0.49|0.84||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||0.84|0.49|
74035480|NCT01552928|147623907|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035481|NCT01552928|147623908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|||||||0.003
74035482|NCT01552928|147623908|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035483|NCT01552928|147623908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||ANCOVA|||||||0.043
74035484|NCT01552928|147623913|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035485|NCT01552928|147623913|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035486|NCT01552928|147623913|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
73991936|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.02|||||TWO_SIDED|95.0|0.66|1.58||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.58|0.66|
73991937|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|1.62|||||TWO_SIDED|95.0|1.14|2.3||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.3|1.14|
73991938|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.74|||||TWO_SIDED|95.0|0.47|1.17||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||1.17|0.47|
73991939|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.46|||||TWO_SIDED|95.0|0.38|0.57||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.57|0.38|
74035487|NCT01552928|147623914|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035488|NCT01552928|147623914|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035489|NCT01552928|147623914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANCOVA|||||||0.004
74035490|NCT01552928|147623915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANCOVA|||||||0.005
74035491|NCT01552928|147623915|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035492|NCT01552928|147623915|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035493|NCT01552928|147623916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078|||||||ANCOVA|||||||0.078
74035494|NCT01552928|147623916|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74035495|NCT01552928|147623916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.156|||||||ANCOVA|||||||0.156
74035496|NCT01552928|147623917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.439|||||||ANCOVA|||||||0.439
74035497|NCT01552928|147623917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274|||||||ANCOVA|||||||0.274
73991940|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.94|||||TWO_SIDED|95.0|0.87|1.02||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.02|0.87|
73991941|NCT02035696|147529928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.57|||||TWO_SIDED|95.0|0.44|0.75||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||0.75|0.44|
73991942|NCT02035696|147529929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|10.0|||||TWO_SIDED|95.0|0.0|18.9||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||18.9|0|
73991943|NCT02035696|147529929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|2.0|||||TWO_SIDED|95.0|-4.0|8.0||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||8|-4|
73991944|NCT02035696|147529929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-11.0|||||TWO_SIDED|95.0|-21.1|-1.5||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-1.5|-21.1|
73991945|NCT02035696|147529929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|7.0|||||TWO_SIDED|95.0|-2.5|16.8||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||16.8|-2.5|
73991946|NCT02035696|147529929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-3.0|||||TWO_SIDED|95.0|-9.5|4.1||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||4.1|-9.5|
73991947|NCT02035696|147529929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-11.0|||||TWO_SIDED|95.0|-20.5|-1.0||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-1|-20.5|
73991948|NCT02035696|147529929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|6.0|||||TWO_SIDED|95.0|-4.2|15.4||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||15.4|-4.2|
73991949|NCT02035696|147529929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-6.0|||||TWO_SIDED|95.0|-13.4|1.3||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||1.3|-13.4|
73991950|NCT02035696|147529929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-18.0|||||TWO_SIDED|95.0|-27.8|-7.2||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-7.2|-27.8|
73991951|NCT02035696|147529930|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
73876435|NCT02365649|147294817|SUPERIORITY||Adjusted risk difference from placebo|7.5||||0.512|TWO_SIDED|95.0|-14.9|29.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.9|-14.9|0.512
73876436|NCT02365649|147294817|SUPERIORITY||Adjusted risk difference from placebo|25.0||||0.035|TWO_SIDED|95.0|-1.8|48.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.2|-1.8|0.035
73876437|NCT02365649|147294817|SUPERIORITY||Adjusted risk difference from placebo|12.5||||0.29|TWO_SIDED|95.0|-10.7|35.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||35.6|-10.7|0.29
73876438|NCT02365649|147294818|SUPERIORITY||Adjusted risk difference from placebo|-0.9||||0.896|TWO_SIDED|95.0|-15.0|13.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||13.1|-15.0|0.896
73991952|NCT02035696|147529930|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
73991953|NCT02035696|147529930|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
73991954|NCT00379769|147529960|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.2 for the upper limit of the 95 percent confidence interval in time to event analysis comparing RSG to MET/SU stratified by background medication|Hazard Ratio (HR)|0.99||||||95.0|0.85|1.16||||||||1.16|0.85|
73991955|NCT00379769|147529984|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||||95.0|0.68|1.08||||||||1.08|0.68|
73991956|NCT00379769|147529985|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.78|1.17||||||||1.17|0.78|
73991957|NCT00379769|147529986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||||95.0|0.79|1.18||||||||1.18|0.79|
73991958|NCT00379769|147529987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21||||||||1.21|0.68|
73991959|NCT00379769|147529988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21||||||||1.21|0.68|
73991960|NCT00379769|147529989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||||95.0|0.8|1.59||||||||1.59|0.80|
73991961|NCT00379769|147529990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||||95.0|0.82|1.62||||||||1.62|0.82|
73991962|NCT00379769|147529991|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||||95.0|0.54|1.14||||||||1.14|0.54|
73991963|NCT00379769|147529992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||||95.0|0.57|1.18||||||||1.18|0.57|
73991964|NCT01536587|147530068|SUPERIORITY_OR_OTHER|||||||0.5062||95.0|||||paired t-Test, 2-sided|||||||0.5062
73991965|NCT03382561|147530116|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.17|TWO_SIDED|95.0|0.55|1.11|||Log Rank||Hazard ratio: Arm A (CEN)/Arm B (CE)|||1.11|0.55|0.17
73991966|NCT01245140|147530122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5731||||0.9705|TWO_SIDED|95.0|-30.9738|32.12|||ANCOVA|||||32.1200|-30.9738|0.9705
73991967|NCT01245140|147530123|SUPERIORITY_OR_OTHER|||||||0.4564||95.0||||PPPASI 50 response|Fisher Exact|||||||0.4564
73991968|NCT01245140|147530123|SUPERIORITY_OR_OTHER|||||||0.6595||95.0||||PPPASI 75 response|Fisher Exact|||||||0.6595
73991969|NCT01245140|147530125|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||Change in Total Pustule Count: BL to Last Visit|Wilcoxon test: Exact Test|||||||0.51
73991970|NCT01245140|147530126|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||Relative change in mPASI score: BL to Last Visit|Wilcoxon test: Exact Test|||||||0.12
73991971|NCT01245140|147530127|SUPERIORITY_OR_OTHER||Least squared estimation|49.4927||||0.2358|TWO_SIDED|95.0|-49.083|148.07|||ANCOVA|||||148.07|-49.0830|0.2358
73991972|NCT01245140|147530128|SUPERIORITY_OR_OTHER|||||||0.1667||95.0||||mPASI 50 response|Fisher Exact|||||||0.1667
73991973|NCT01245140|147530128|SUPERIORITY_OR_OTHER|||||||0.1667||95.0||||mPASI 75 response|Fisher Exact|||||||0.1667
73991974|NCT01653210|147530154|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||||||0.023
73991975|NCT00513747|147530182|SUPERIORITY|||||||0.1521|||||||Log Rank|||||||0.1521
73991976|NCT00513747|147530183|SUPERIORITY|||||||0.0097|||||||Log Rank|||||||0.0097
73991977|NCT00513747|147530184|SUPERIORITY|||||||0.4645|||||||Log Rank|||||||0.4645
73991978|NCT01575873|147530204|NON_INFERIORITY|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of -1.1 percentage points for the glucocorticoid-initiating subpopulation.|LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.0|3.9||One-sided p-value based on the prespecified noninferiority margin for lumbar spine of -1.1%.|ANCOVA||Least Squares (LS) Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within the glucocorticoid-continuing and glucocorticoid-initiating subpopulations. A fixed-sequence testing procedure was used to control the experiment-wise type 1 error rate at a two-sided 5% significance level within each subpopulation.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD, sex, machine type, and baseline BMD-by-machine type interaction."||3.9|2.0|< 0.001
73991979|NCT01575873|147530204|NON_INFERIORITY|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of -0.7 percentage points for the glucocorticoid-continuing subpopulation.|LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.4|3.0||One-sided p-value based on the prespecified noninferiority margins for lumbar spine of -0.7%.|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.0|1.4|< 0.001
73991980|NCT01575873|147530205|SUPERIORITY||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.0|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||3.9|2.0|< 0.001
73991981|NCT01575873|147530205|SUPERIORITY||LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.4|3.0||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.0|1.4|< 0.001
73991982|NCT01575873|147530206|SUPERIORITY||LS Mean Difference|1.5|||<|0.001|TWO_SIDED|95.0|0.8|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||2.1|0.8|< 0.001
73876439|NCT02365649|147294818|SUPERIORITY||Adjusted risk difference from placebo|18.6||||0.05|TWO_SIDED|95.0|0.0|37.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.3|0.0|0.05
74009233|NCT01380730|147569257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.8|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-50.92|-40.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-40.67|-50.92|<0.001
74035498|NCT01552928|147623917|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
73991983|NCT01575873|147530206|SUPERIORITY||LS Mean Difference|1.5|||<|0.001|TWO_SIDED|95.0|1.0|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||2.1|1.0|< 0.001
73991984|NCT01575873|147530207|SUPERIORITY||LS Mean Difference|4.5|||<|0.001|TWO_SIDED|95.0|3.2|5.8||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||5.8|3.2|< 0.001
73991985|NCT01575873|147530207|SUPERIORITY||LS Mean Difference|3.2|||<|0.001|TWO_SIDED|95.0|2.0|4.3||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||4.3|2.0|< 0.001
73991986|NCT01575873|147530208|SUPERIORITY||LS Mean Difference|3.1|||<|0.001|TWO_SIDED|95.0|2.2|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||3.9|2.2|< 0.001
73991987|NCT01575873|147530208|SUPERIORITY||LS Mean Difference|2.5|||<|0.001|TWO_SIDED|95.0|1.7|3.2||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.2|1.7|< 0.001
73991988|NCT00965497|147530217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|95.0||||0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||There were 13 people that completed so there truly was no power to detect true differences; therefore only trends can be discussed.||||0.01
73991989|NCT01827046|147530227|SUPERIORITY||Risk Difference (RD)|2.0||||0.73|TWO_SIDED|95.0|-6.8|10.7|||Chi-squared|||||10.7|-6.8|0.73
73991990|NCT01827046|147530227|SUPERIORITY||Risk Difference (RD)|4.0||||0.33|TWO_SIDED|95.0|-4.0|12.0|||Multivariate logit model|||Adjusted for age, GCS, stability ICH volume, stability IVH volume, ICH deep location||12|-4|0.33
73991991|NCT01827046|147530228|SUPERIORITY||Risk Difference (RD)|0.03||||0.55|TWO_SIDED|95.0|-0.06|0.11|||Chi-squared|||||0.11|-0.06|0.55
73991992|NCT01827046|147530228|SUPERIORITY||Risk Difference (RD)|1.26||||0.27|TWO_SIDED|95.0|0.82|1.97|||Multivariate logit model|Adjusted for age, GCS, stability ICH volume, stability IVH volume and ICH deep location||||1.97|0.82|0.27
74035499|NCT04030104|147623918|SUPERIORITY|||||||0.0268||||||Threshold for statistical significance \<0.05|Random Reader, Random Mass|Curve Fitting Method: Empirical||||||0.0268
73991993|NCT01827046|147530229|SUPERIORITY|||||||0.08|TWO_SIDED|95.0|||||Log Rank|||||||0.08
73991994|NCT01827046|147530229|SUPERIORITY||Cox Proportional Hazard|0.67||||0.037|TWO_SIDED|95.0|0.45|0.98|||Adjusted Cox proportional Hazard|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location, diabetes, cardiovascular disease and race.||||0.98|0.45|0.037
73991995|NCT01827046|147530230|SUPERIORITY||Odds Ratio (OR)|0.7|||<|0.001|TWO_SIDED|95.0|0.62|0.8|||Logit model|||||0.80|0.62|<0.001
73991996|NCT01827046|147530230|SUPERIORITY||Odds Ratio (OR)|0.68|||<|0.001|TWO_SIDED|95.0|0.59|0.78|||Multivariate logit model|Adjusted for age, GCS, stability IVH volume, and ICH deep location||||0.78|0.59|<0.001
73991997|NCT01827046|147530231|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
73991998|NCT01827046|147530232|SUPERIORITY||Risk Difference (RD)|0.04||||0.34|TWO_SIDED|95.0|-0.04|0.11|||Chi-squared|||||0.11|-0.04|0.34
73991999|NCT01827046|147530233|SUPERIORITY||Risk Difference (RD)|-0.01||||0.76|TWO_SIDED|95.0|-0.1|0.07|||Chi-squared|||||0.07|-0.10|0.76
73992000|NCT01827046|147530233|SUPERIORITY||Odds Ratio (OR)|1.25||||0.31|TWO_SIDED|95.0|0.81|1.94|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location||||1.94|0.81|0.31
73992001|NCT01827046|147530234|SUPERIORITY||Risk Difference (RD)|0.01||||0.79|TWO_SIDED|95.0|-0.07|0.09|||Chi-squared|||||0.09|-0.07|0.79
73992002|NCT01827046|147530234|SUPERIORITY||Odds Ratio (OR)|1.24||||0.35|TWO_SIDED|95.0|0.79|1.97|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location||||1.97|0.79|0.35
73992003|NCT01827046|147530235|SUPERIORITY|||||||0.46|||||||Median test|||||||0.46
73992004|NCT01827046|147530236|SUPERIORITY|||||||0.75|||||||Median test|||||||0.75
73992005|NCT01827046|147530237|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
73992006|NCT01827046|147530238|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
73992007|NCT01827046|147530239|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
74035500|NCT04570657|147623922|SUPERIORITY||LS mean difference|0.036||||0.267|TWO_SIDED|80.0|-0.038|0.111||One-sided p-value|MMRM||Tozorakimab Dose A - Placebo|||0.111|-0.038|0.267
74035501|NCT04570657|147623922|SUPERIORITY||LS mean difference|0.004||||0.473|TWO_SIDED|80.0|-0.071|0.079||One-sided p-value|MMRM||Tozorakimab Dose B - Placebo|||0.079|-0.071|0.473
74035502|NCT04570657|147623923|SUPERIORITY||LS mean difference|-0.012||||0.437|TWO_SIDED|80.0|-0.11|0.086||One-sided p-value|MMRM||Week 8: Tozorakimab Dose A - Placebo|||0.086|-0.110|0.437
73992008|NCT01827046|147530240|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
73992009|NCT01827046|147530241|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
73992010|NCT01827046|147530242|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
73992011|NCT01827046|147530243|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
73992012|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|2.39|||||TWO_SIDED|95.0|1.39|4.1|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||4.1|1.39|
73992013|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|0.71|||||TWO_SIDED|95.0|0.42|1.2|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||1.2|0.42|
73992014|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|1.68|||||TWO_SIDED|95.0|0.98|2.9|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||2.9|0.98|
73992015|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|1.31|||||TWO_SIDED|95.0|0.59|2.91|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||2.91|0.59|
73992016|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|24.0|||||TWO_SIDED|95.0|11.0|52.0|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||52|11|
74090014|NCT01013649|147733058|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.38|TWO_SIDED|90.0|0.79|1.18||One-sided significance level = 0.05.|Log Rank||Reference level = Arm III|316 deaths from step 2 randomized patients provides 80% power, with 0.05 1-sided alpha, to detect an OS increase (HR=0.76 in favor of arm IV), corresponding to increasing median OS from 17 to 22.5 months with the addition of RT. For analysis triggered by patients having 5 years potential follow-up from step 2 randomization, it is projected that at least 265 events will be observed, providing at least 72% power. The trigger used for the primary analysis was 5-years of follow-up (270 deaths).||1.18|0.79|0.38
73992017|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|31.0|||||TWO_SIDED|95.0|14.0|69.0|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||69|14|
73992018|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|1.3|||||TWO_SIDED|95.0|0.7|2.42|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||2.42|0.7|
73992019|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|5.56|||||TWO_SIDED|95.0|3.01|10.0|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||10|3.01|
74090015|NCT01013649|147733059|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.8|1.31|||||Reference level = Arm I|||1.31|0.80|
73992020|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|7.22|||||TWO_SIDED|95.0|3.86|13.0|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||13|3.86|
73992021|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|2.64|||||TWO_SIDED|95.0|1.4|4.99|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||4.99|1.4|
73992022|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|1.05|||||TWO_SIDED|95.0|0.56|1.97|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||1.97|0.56|
73992023|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|2.78|||||TWO_SIDED|95.0|1.47|5.27|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||5.27|1.47|
73992024|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|0.52|||||TWO_SIDED|95.0|0.23|1.13|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||1.13|0.23|
73992025|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|45.0|||||TWO_SIDED|95.0|21.0|97.0|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||97|21|
73992026|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|23.0|||||TWO_SIDED|95.0|10.0|51.0|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||51|10|
73992027|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|0.4|||||TWO_SIDED|95.0|0.2|0.82|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||0.82|0.2|
73992028|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|24.0|||||TWO_SIDED|95.0|12.0|48.0|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||48|12|
73992029|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|9.61|||||TWO_SIDED|95.0|4.69|20.0|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||20|4.69|
74090016|NCT01013649|147733060|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|90.0|0.68|0.99|||||Reference level = Arm III|||0.99|0.68|
73992030|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|1.11|||||TWO_SIDED|95.0|0.55|2.21|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||2.21|0.55|
73992031|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|2.51|||||TWO_SIDED|95.0|1.27|4.96|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||4.96|1.27|
73992032|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|2.77|||||TWO_SIDED|95.0|1.38|5.57|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||5.57|1.38|
73992033|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|0.54|||||TWO_SIDED|95.0|0.28|1.04|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||1.04|0.28|
73992034|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|50.0|||||TWO_SIDED|95.0|26.0|94.0|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||94|26|
73992035|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|27.0|||||TWO_SIDED|95.0|14.0|52.0|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||52|14|
73992036|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|0.6|||||TWO_SIDED|95.0|0.34|1.04|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||1.04|0.34|
73992037|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|35.0|||||TWO_SIDED|95.0|20.0|60.0|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||60|20|
73992038|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|21.0|||||TWO_SIDED|95.0|12.0|36.0|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||36|12|
73992039|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|0.9|||||TWO_SIDED|95.0|0.48|1.69|||ANOVA|||Day 1, Men Y, Pairwise comparison of geometric mean titer||1.69|0.48|
73992040|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|3.61|||||TWO_SIDED|95.0|1.94|6.74||||||Day 1, Men Y, Pairwise comparison of geometric mean titer||6.74|1.94|
73992041|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|3.24|||||TWO_SIDED|95.0|1.71|6.13|||ANOVA|||Day 1, Men Y, Pairwise comparison of geometric mean titer||6.13|1.71|
73992042|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|0.33|||||TWO_SIDED|95.0|0.16|0.66|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||0.66|0.16|
73992043|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|121.0|||||TWO_SIDED|95.0|61.0|241.0|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||241|61|
73992044|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|40.0|||||TWO_SIDED|95.0|20.0|80.0|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||80|20|
73992045|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|0.58|||||TWO_SIDED|95.0|0.32|1.05|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||1.05|0.32|
73992046|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|33.0|||||TWO_SIDED|95.0|18.0|60.0|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||60|18|
73992047|NCT01018732|147530281|SUPERIORITY_OR_OTHER||ratio of titer|19.0|||||TWO_SIDED|95.0|10.0|35.0|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||35|10|
73992048|NCT02781311|147530391|SUPERIORITY||Least-squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|4.45||0.9239|TWO_SIDED|95.0|-8.38|9.23||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age and baseline TAHC value, with the Type III sum of squares.|ANCOVA|||||9.23|-8.38|0.9239
73992049|NCT02781311|147530392|SUPERIORITY||Least-squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.9101|TWO_SIDED|95.0|-0.42|0.37||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age, with the Type III sum of squares.|ANCOVA|||||0.37|-0.42|0.9101
73992050|NCT01056263|147530399|SUPERIORITY_OR_OTHER||Five year survival probability|20.6|||||TWO_SIDED|95.0|10.94|32.38||||||Five year survival probability was the probability of survival at 5 year after the date of the start of the study treatment based on the Kaplan-Meier estimate.||32.38|10.94|
73992051|NCT01310699|147530480|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
73992052|NCT01310699|147530481|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
73992053|NCT02201901|147530489|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 12 weeks (Group 1) over prespecified rate of 1% .||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
73992054|NCT02201901|147530489|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 weeks (Group 2) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
73992055|NCT02201901|147530489|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 24 weeks (Group 3) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
73992056|NCT02242643|147530497|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|Seroconversion rate (SCR) Difference (%)|-6.32|||||TWO_SIDED|95.0|-10.34|-2.27|||||For A/California/7/2009 (H1N1) vaccine strain.|||-2.27|-10.34|
73992057|NCT02242643|147530497|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-6.74|||||TWO_SIDED|95.0|-10.68|-2.8|||||For A/Texas/50/2012 (H3N2) vaccine strain|||-2.80|-10.68|
73992058|NCT02242643|147530497|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-16.38|||||TWO_SIDED|95.0|-20.68|-12.02|||||For B/Massachusetts/2/2012 (Yamagata) vaccine strain|||-12.02|-20.68|
73992059|NCT02242643|147530497|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-11.75|||||TWO_SIDED|95.0|-15.28|-8.21|||||For B/Brisbane/60/2008 (Victoria) vaccine strain.|||-8.21|-15.28|
73992060|NCT02242643|147530498|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.95|0.77|
74035503|NCT04570657|147623923|SUPERIORITY||LS mean difference|0.059||||0.221|TWO_SIDED|80.0|-0.039|0.157||One-sided p-value|MMRM||Week 8: Tozorakimab Dose B - Placebo|||0.157|-0.039|0.221
74009234|NCT01380730|147569257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-42.94|-32.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-32.65|-42.94|<0.001
74009235|NCT01380730|147569258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.45|STANDARD_ERROR_OF_MEAN|2.46|<|0.001|TWO_SIDED|95.0|-61.28|-51.61||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-51.61|-61.28|<0.001
74009236|NCT01380730|147569258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.15|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-54.97|-45.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-45.33|-54.97|<0.001
74009237|NCT01380730|147569258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.74|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-39.56|-29.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.92|-39.56|<0.001
74009238|NCT01380730|147569258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.03|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-47.16|-36.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-36.90|-47.16|<0.001
74009239|NCT01380730|147569258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.77|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-45.88|-35.66||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-35.66|-45.88|<0.001
73992061|NCT02242643|147530498|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.94|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.94|0.77|
73992062|NCT02242643|147530498|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.65|||||TWO_SIDED|95.0|0.59|0.71|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.71|0.59|
73992063|NCT02242643|147530498|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.62|||||TWO_SIDED|95.0|0.56|0.69|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.69|0.56|
73992064|NCT02633397|147530521|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.19
73992065|NCT02633397|147530522|SUPERIORITY|||||||0.42|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.42
73992066|NCT02633397|147530523|SUPERIORITY|||||||0.52|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.52
73992067|NCT02633397|147530525|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.69|TWO_SIDED|90.0|-0.7|0.42|||ANCOVA|||ANCOVA model adjusted for clinic site||0.42|-0.70|0.69
73992068|NCT02633397|147530526|SUPERIORITY||Mean Difference (Final Values)|-39.51||||0.4|TWO_SIDED|90.0|-117.05|38.02|||ANCOVA|||ANCOVA model adjusted for clinic site||38.02|-117.05|0.40
73992069|NCT02633397|147530527|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.23|TWO_SIDED|90.0|-0.11|0.73|||Regression, Linear|||Linear regression model adjusted for clinic site||0.73|-0.11|0.23
73992070|NCT02633397|147530528|SUPERIORITY||Mean Difference (Final Values)|-0.08||||-0.8|TWO_SIDED|90.0|-0.62|0.46|||ANCOVA|||ANCOVA model adjusted for clinic site||0.46|-0.62|-0.80
73992071|NCT02633397|147530529|SUPERIORITY||Mean Difference (Final Values)|-6.96|||<|0.001|TWO_SIDED|90.0|-10.22|-3.69|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in MAP as a function of time, the interaction between time and study arm, and clinic site.||-3.69|-10.22|<0.001
73992072|NCT02633397|147530530|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.15|TWO_SIDED|90.0|-0.31|0.02|||ANCOVA|||ANCOVA model adjusted for clinic site||0.02|-0.31|0.15
73992073|NCT02633397|147530531|SUPERIORITY||Mean Difference (Final Values)|-6.7||||0.003|TWO_SIDED|90.0|-10.28|-3.12|||ANCOVA|||ANCOVA model adjusted for clinic site||-3.12|-10.28|0.003
73992074|NCT02633397|147530532|SUPERIORITY||Mean Difference (Final Values)|3.52|||<|0.001|TWO_SIDED|90.0|2.0|5.04|||ANCOVA|||ANCOVA model adjusted for clinic site||5.04|2.00|<0.001
73992075|NCT02633397|147530533|SUPERIORITY||Mean Difference (Final Values)|286.56||||0.51|TWO_SIDED|90.0|-429.86|1002.99|||Regression, Linear|||Linear regression model adjusted for clinic site||1002.99|-429.86|0.51
73992076|NCT02633397|147530534|SUPERIORITY||Mean Difference (Final Values)|-82.18||||0.14|TWO_SIDED|90.0|-173.69|9.32|||Regression, Linear|||Linear regression model adjusted for clinic site||9.32|-173.69|0.14
73992077|NCT02633397|147530535|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare microalbuminuria frequency as a function of time and the interaction between time and study arm.||||0.78
73992078|NCT02633397|147530536|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare macroalbuminuria frequency as a function of time and the interaction between time and study arm.||||0.30
73876440|NCT02365649|147294818|SUPERIORITY||Adjusted risk difference from placebo|3.0||||0.702|TWO_SIDED|95.0|-12.4|18.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||18.4|-12.4|0.702
73992079|NCT02633397|147530537|SUPERIORITY||Mean Difference (Final Values)|-4.91||||0.06|TWO_SIDED|90.0|-9.21|-0.62|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in GFR as a function of time, the interaction between time and study arm, and clinic site.||-0.62|-9.21|0.06
73992080|NCT02633397|147530538|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare CKD stage frequency as a function of time and the interaction between time and study arm.||||0.56
73992081|NCT02633397|147530539|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.15|TWO_SIDED|90.0|-0.52|0.03|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in hemoglobin as a function of time, the interaction between time and study arm, and clinic site.||0.03|-0.52|0.15
73992082|NCT02633397|147530540|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.05|TWO_SIDED|90.0|0.22|2.72|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in reticulocyte count as a function of time, the interaction between time and study arm, and clinic site.||2.72|0.22|0.05
73992083|NCT02633397|147530541|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.75|TWO_SIDED|90.0|-0.93|0.63|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in WBC count as a function of time, the interaction between time and study arm, and clinic site.||0.63|-0.93|0.75
73992084|NCT02633397|147530542|SUPERIORITY||Mean Difference (Final Values)|-29.28||||0.17|TWO_SIDED|90.0|-64.63|6.08|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in WBC count as a function of time, the interaction between time and study arm, and clinic site.||6.08|-64.63|0.17
73992085|NCT02633397|147530543|SUPERIORITY||Mean Difference (Final Values)|-1.64||||0.07|TWO_SIDED|90.0|-3.13|-0.15|||Regression, Linear|||Linear regression model adjusted for clinic site||-0.15|-3.13|0.07
74035504|NCT04570657|147623923|SUPERIORITY||LS mean difference|-0.038||||0.308|TWO_SIDED|80.0|-0.136|0.06||One-sided p-value|MMRM||Week 16: Tozorakimab Dose A - Placebo|||0.060|-0.136|0.308
73992086|NCT03494985|147530547|OTHER||Least square mean difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.4|0.9||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||0.9|0.4|<0.0001
73992087|NCT03494985|147530547|OTHER||LS mean difference|0.9|||<|0.0001|TWO_SIDED|95.0|0.6|1.2||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||1.2|0.6|<0.0001
73992088|NCT03494985|147530547|OTHER||LS mean difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.3|0.9||p-value was adjusted using Dunnett's method for multiple comparisons.|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||0.9|0.3|<0.0001
73992089|NCT03036124|147530554|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.0001||95.0|0.65|0.85|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.85|0.65|<0.0001
73992090|NCT03036124|147530555|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.0001||95.0|0.65|0.85|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.85|0.65|<0.0001
73992091|NCT03036124|147530556|SUPERIORITY||Rate Ratio (RR)|0.75||||0.0002||95.0|0.65|0.88|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.88|0.65|0.0002
73992092|NCT03036124|147530557|SUPERIORITY||Win Ratio (WR)|1.18|||<|0.0001||95.0|1.11|1.26||The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score and stratified by T2DM status at randomization.|Win Ratio|Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.|The composite of change from baseline in total symptom score at 8 months, or death before 8 months.|||1.26|1.11|<0.0001
73992093|NCT03036124|147530558|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.1681||95.0|0.44|1.16|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including baseline eGFR as a covariate.||||1.16|0.44|0.1681
73992094|NCT03036124|147530559|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0217||95.0|0.71|0.97|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||||0.97|0.71|0.0217
73992095|NCT05093504|147530568|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
73992096|NCT02272244|147530578|SUPERIORITY||Odds Ratio (OR)|4.83|||<|0.001|TWO_SIDED|95.0|3.08|7.58|||Regression, Logistic|Model adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage||||7.58|3.08|<0.001
73992097|NCT02272244|147530579|SUPERIORITY||Odds Ratio (OR)|4.91|||<|0.001|TWO_SIDED|95.0|2.55|9.47|||Regression, Logistic|Model compares Forward Change to No Change or Backwards Change and is adjusted for all baseline covariates.||||9.47|2.55|<0.001
73992098|NCT02272244|147530580|SUPERIORITY||||||<|0.001|||||||Regression, Multinomial|Model compared rates of SBT, CX and none; model is adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage|||Reference for the outcome is No Screening; reference for the study group is the Standard Intervention group.|||<0.001
73992099|NCT02272244|147530580|SUPERIORITY||Odds Ratio (OR)|4.2||||0.001|TWO_SIDED|95.0|2.63|6.7|||Odds Ratio (OR)|Stool Blood Test vs None||||6.70|2.63|0.001
73992100|NCT02272244|147530580|SUPERIORITY|Colonscopy vs None|Odds Ratio (OR)|8.79||||0.001|TWO_SIDED|95.0|4.13|18.74|||Odds Ratio (OR)|||||18.74|4.13|0.001
73992101|NCT02272244|147530581|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.862|TWO_SIDED|95.0|-0.15|0.13|||Regression, Linear|Model of difference in Preventive Health Model (PHM) total score adjusts for all baseline covariates.|Model compares DSNI to SI.|||0.13|-0.15|0.862
73992102|NCT02272244|147530581|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.88|TWO_SIDED|95.0|-0.47|0.55|||Regression, Linear|Model of knowledge test score adjusts for all baseline covariates|Model compares DSNI to SI.|||.55|-.47|0.880
73992103|NCT03670277|147530582|OTHER|Statistically significance of difference. Statistical difference will be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|-0.013|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.081|0.056|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.||0.056|-0.081|
73992104|NCT03670277|147530583|OTHER|Statistically significance of difference. Statistical difference will be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|0.031|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.037|0.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.||0.100|-0.037|
73992105|NCT03670277|147530584|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|3.403|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|2.557|4.248|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|At -30°||4.248|2.557|
73992106|NCT03670277|147530584|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|2.431|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|1.585|3.277|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|At +30°||3.277|1.585|
74035505|NCT04570657|147623923|SUPERIORITY||LS mean difference|-0.025||||0.372|TWO_SIDED|80.0|-0.122|0.072||One-sided p-value|MMRM||Week 16: Tozorakimab Dose B - Placebo|||0.072|-0.122|0.372
74035506|NCT04570657|147623926|SUPERIORITY||LS mean difference|-0.03||||0.416|TWO_SIDED|80.0|-0.215|0.154||One-sided p-value|MMRM||Tozorakimab Dose A - Placebo|||0.154|-0.215|0.416
74035507|NCT04570657|147623926|SUPERIORITY||LS mean difference|-0.047||||0.371|TWO_SIDED|80.0|-0.231|0.137||One-sided p-value|MMRM||Tozorakimab Dose B - Placebo|||0.137|-0.231|0.371
74090017|NCT04285567|147733066|SUPERIORITY||Difference in Rates|26.6||||0.0004|TWO_SIDED|95.0|12.33|40.87|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.||40.87|12.33|0.0004
73992107|NCT03670277|147530585|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|3.039|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|95.0|1.854|4.225|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test - Control|At -30°||4.225|1.854|
73992108|NCT03670277|147530585|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|1.414|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|95.0|0.228|2.599|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test - Control|At +30°||2.599|0.228|
73992109|NCT02660112|147530586|SUPERIORITY|||||||0.336|||||||Wilcoxon (Mann-Whitney)|||||||0.336
73992110|NCT03728985|147530618|NON_INFERIORITY|Performance Goal 80%|Absolute Percentage with Success|77.5||||0.5908|TWO_SIDED|90.0|69.6|84.1|||Fisher Exact||The lower estimated confidence interval above the Performance Goal of 80% would be considered success.|||84.1|69.6|0.5908
73992111|NCT03728985|147530619|NON_INFERIORITY|Performance Goal 68%|Percentage with Success|70.6||||0.7017|TWO_SIDED|90.0|61.4|78.7|||Fisher Exact|||||78.7|61.4|0.7017
73992112|NCT01867047|147530654|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Statistical analysis for intraoperative mild hypotension||||0.140
73992113|NCT01867047|147530654|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Statistical analysis for postoperative mild hypotension||||1.000
73992114|NCT01867047|147530656|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||Analysis for number of participants given vasopressors intraoperatively||||0.102
73992115|NCT01867047|147530659|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.700
73992116|NCT01867047|147530660|SUPERIORITY|||||||0.702|||||||t-test, 2 sided|||||||0.702
73992117|NCT01434680|147530676|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons, MenC-CRM LIQ and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.82|||<|0.05|TWO_SIDED|95.0|0.67|1.0|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10 transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM LIQ to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).||1.00|0.67|<0.05
73992118|NCT01434680|147530676|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons,MenC-CRM ROS and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|1.14|||<|0.05|TWO_SIDED|95.0|0.92|1.41|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM ROS to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).||1.41|0.92|<0.05
73992119|NCT01434680|147530677|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval, the two vaccine groups would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.72|||<|0.05|TWO_SIDED|95.0|0.58|0.89|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The secondary objective was to be assessed only if both primary objectives were met. Because of this, no adjustment for multiplicity was required. MenC-CRM liquid would be declared equivalent to MenC-CRM ROS if the two-sided 95% CI for the ratio of the hSBA GMTs at approximately 28 days following vaccination was within the equivalence interval (0.5, 2.0).||0.89|0.58|<0.05
73992120|NCT01515943|147530679|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.56|TWO_SIDED|97.5|-19.0|11.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Biniomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Negative values for the treatment group difference favor the HB-PU group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-PU groups, assuming true population success percentages of 30% and 15% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (\<28 points vs ≥28 points), mean NPC break (\<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs \<15 pd).||11|-19|0.56
74009240|NCT01380730|147569258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.38|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-39.51|-29.25||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.25|-39.51|<0.001
74009241|NCT01380730|147569259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.74|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-52.18|-43.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.29|-52.18|<0.001
74090018|NCT04285567|147733068|SUPERIORITY||Difference in Rates|20.78||||0.0053|TWO_SIDED|95.0|6.66|34.9|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||34.90|6.66|0.0053
73992121|NCT01515943|147530680|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.52|TWO_SIDED|97.5|-12.0|22.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Binomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Positive values for the treatment group difference favor the HB-C group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-P groups, assuming true population success percentages of 30% and 10% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (\<28 points vs ≥28 points), mean NPC break (\<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs \<15 pd).||22|-12|0.52
74035508|NCT04570657|147623927|SUPERIORITY||Odds Ratio (OR)|1.2||||0.612|TWO_SIDED|80.0|0.76|1.9|||Chi-squared|||||1.90|0.76|0.612
74035509|NCT04570657|147623927|SUPERIORITY||Odds Ratio (OR)|1.41||||0.348|TWO_SIDED|80.0|0.88|2.25|||Chi-squared|||||2.25|0.88|0.348
73992122|NCT01515943|147530686|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.0|||<|0.01|TWO_SIDED|95.0|-27.0|17.0|||Bernard's exact test|A p-value was not reported in the manuscript results, but has been included here, reported directly from the analysis.||For the HB-C group, the association between completion of the computer vergence/accommodative therapy (CVAT) program (defined as achieving at least 15 stars for the jump vergence exercise) and overall success at 12 weeks was evaluated using Bernard's exact test.||17|-27|<0.01
73992123|NCT05224843|147530697|OTHER||Percentage of enrolled from eligible|82.5|||||TWO_SIDED|95.0|73.7|88.8||||||||88.8|73.7|
73992124|NCT05224843|147530698|OTHER||Percentage of enrolled from eligible|100.0|||||TWO_SIDED|95.0|95.4|100.0||||||||100|95.4|
73992125|NCT05224843|147530700|OTHER||Percentage screened positive for EM|7.5|||||TWO_SIDED|95.0|3.5|15.4||||||||15.4|3.5|
73992126|NCT05224843|147530702|OTHER||Percentage who changed after BNI|25.0|||||TWO_SIDED|95.0|4.6|69.9||||||||69.9|4.6|
73992127|NCT05224843|147530703|OTHER||Percentage reported APS from EM positive|20.0|||||TWO_SIDED|95.0|3.6|62.4||||||||62.4|3.6|
73992128|NCT02701062|147530745|SUPERIORITY|||||||0.2593|||||||Fisher Exact|||||||0.2593
73992129|NCT02701062|147530746|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73992130|NCT02701062|147530747|SUPERIORITY|||||||0.1238|||||||Fisher Exact|||||||0.1238
73992131|NCT02701062|147530748|SUPERIORITY|||||||0.6603|||||||t-test, 2 sided|||LOS (Total)||||0.6603
73992132|NCT02701062|147530748|SUPERIORITY|||||||0.0783|||||||t-test, 2 sided|||LOS (Post-Procedure)||||0.0783
74035510|NCT04570657|147623928|SUPERIORITY||Odds Ratio (OR)|0.81||||0.575|TWO_SIDED|80.0|0.5|1.31|||Chi-squared|||||1.31|0.50|0.575
74035511|NCT04570657|147623928|SUPERIORITY||Odds Ratio (OR)|0.86||||0.679|TWO_SIDED|80.0|0.53|1.38|||Chi-squared|||||1.38|0.53|0.679
74035512|NCT04570657|147623929|SUPERIORITY||LS mean difference|0.002||||0.5|TWO_SIDED|80.0|-3.825|3.828||One-sided p-value|MMRM||SGRQ Activity Total Score: Tozorakimab Dose A - Placebo|||3.828|-3.825|0.500
74035513|NCT04570657|147623929|SUPERIORITY||LS mean difference|-1.364||||0.324|TWO_SIDED|80.0|-5.198|2.47||One-sided p-value|MMRM||SGRQ Activity Total Score: Tozorakimab Dose B - Placebo|||2.470|-5.198|0.324
73992133|NCT02701062|147530748|SUPERIORITY|||||||0.4282|||||||t-test, 2 sided|||Readmission LOS (per subject)||||0.4282
73992134|NCT02701062|147530749|SUPERIORITY|||||||0.6603|||||||t-test, 2 sided|||||||0.6603
73992135|NCT02701062|147530749|SUPERIORITY|||||||0.0783|||||||t-test, 2 sided|||LOS (Post-Procedure)||||0.0783
73992136|NCT02701062|147530749|SUPERIORITY|||||||0.4282|||||||t-test, 2 sided|||Readmission LOS (per subject)||||0.4282
73992137|NCT02701062|147530750|SUPERIORITY|||||||0.5442|||||||Fisher Exact|||Reoperation||||0.5442
73992138|NCT02701062|147530750|SUPERIORITY|||||||0.2598|||||||Fisher Exact|||ED Visit||||0.2598
73992139|NCT02701062|147530750|SUPERIORITY|||||||0.5442|||||||Fisher Exact|||Neurologic Consult||||0.5442
73992140|NCT02701062|147530750|SUPERIORITY|||||||0.2921|||||||Fisher Exact|||Hospital Readmission (per subject)||||0.2921
73992141|NCT00781937|147530776|SUPERIORITY_OR_OTHER||Treatment Contrast|-6.06|||<|0.0001||95.0|-7.5|-4.62||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||-4.62|-7.50|<0.0001
73992142|NCT00781937|147530777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.82|||<|0.0001||95.0|3.01|7.71||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||7.71|3.01|<0.0001
73992143|NCT00781937|147530778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.44|6.09||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||6.09|2.44|<0.0001
73992144|NCT00781937|147530779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.3|||<|0.0001||95.0|2.79|10.08||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||10.08|2.79|<0.0001
74035514|NCT04570657|147623929|SUPERIORITY||LS mean difference|-1.421||||0.248|TWO_SIDED|80.0|-4.103|1.26||One-sided p-value|MMRM||SGRQ Impacts Total Score: Tozorakimab Dose A - Placebo|||1.260|-4.103|0.248
73992145|NCT00781937|147530780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09|||<|0.0001||95.0|0.03|0.26||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||0.26|0.03|<0.0001
73992146|NCT00781937|147530782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.86|||<|0.0001||95.0|3.12|10.98||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||10.98|3.12|<0.0001
73992147|NCT00781937|147530783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.02|||<|0.0001||95.0|3.65|9.92||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||9.92|3.65|<0.0001
73992148|NCT00781937|147530784|SUPERIORITY_OR_OTHER||Treatment Contrast|-5.86|||<|0.0001||95.0|-7.3|-4.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-4.43|-7.30|<0.0001
73992149|NCT00781937|147530785|SUPERIORITY_OR_OTHER||Treatment Contrast|-4.23|||<|0.0001||95.0|-6.04|-2.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.43|-6.04|<0.0001
73992150|NCT00781937|147530786|SUPERIORITY_OR_OTHER||Treatment Contrast|-2.72||||0.0068||95.0|-4.69|-0.76||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in systolic blood pressure.||-0.76|-4.69|0.0068
73992151|NCT00781937|147530786|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.34||||0.6386||95.0|-1.74|1.07||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in diastolic blood pressure.||1.07|-1.74|0.6386
73992152|NCT00781937|147530787|SUPERIORITY_OR_OTHER||Treatment Contrast|0.97||||0.1968||95.0|-0.51|2.45||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||2.45|-0.51|0.1968
73992153|NCT00781937|147530788|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.11||||0.031||95.0|-0.2|-0.01||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.01|-0.20|0.0310
73992154|NCT00781937|147530789|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.09||||0.1098||95.0|-0.2|0.02||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||0.02|-0.20|0.1098
73992155|NCT00781937|147530790|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.11||||0.1149||95.0|-0.24|0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||0.03|-0.24|0.1149
74035515|NCT04570657|147623929|SUPERIORITY||LS mean difference|-1.694||||0.21|TWO_SIDED|80.0|-4.383|0.996||One-sided p-value|MMRM||SGRQ Impacts Total Score: Tozorakimab Dose B - Placebo|||0.996|-4.383|0.210
74035516|NCT04570657|147623929|SUPERIORITY||LS mean difference|0.691||||0.42|TWO_SIDED|80.0|-3.715|5.096||One-sided p-value|MMRM||SGRQ Symptoms Total Score: Tozorakimab Dose A - Placebo|||5.096|-3.715|0.420
74035517|NCT04570657|147623929|SUPERIORITY||LS mean difference|-3.15||||0.181|TWO_SIDED|80.0|-7.579|1.28||One-sided p-value|MMRM||SGRQ Symptoms Total Score: Tozorakimab Dose B - Placebo|||1.280|-7.579|0.181
74035518|NCT04570657|147623929|SUPERIORITY||LS mean difference|-0.663||||0.38|TWO_SIDED|80.0|-3.454|2.129||One-sided p-value|MMRM||SGRQ Total Score: Tozorakimab Dose A - Placebo|||2.129|-3.454|0.380
74035519|NCT04570657|147623929|SUPERIORITY||LS mean difference|-1.896||||0.192|TWO_SIDED|80.0|-4.694|0.903||One-sided p-value|MMRM||SGRQ Total Score: Tozorakimab Dose B - Placebo|||0.903|-4.694|0.192
74035520|NCT04570657|147623930|SUPERIORITY||Odds Ratio (OR)|0.93||||0.828|TWO_SIDED|80.0|0.59|1.46|||Chi-squared|||||1.46|0.59|0.828
73876441|NCT02365649|147294818|SUPERIORITY||Adjusted risk difference from placebo|14.3||||0.117|TWO_SIDED|95.0|-3.6|32.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.2|-3.6|0.117
73992156|NCT00781937|147530791|SUPERIORITY_OR_OTHER||Treatment Contrast|-13.01||||0.0141||95.0|-23.4|-2.64||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.64|-23.40|0.0141
73992157|NCT00781937|147530792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.1199||95.0|0.36|1.12||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, and stratification factor(s) as fixed effects and metabolic status and weight at baseline as covariates.||||1.12|0.36|0.1199
73992158|NCT00781937|147530793|SUPERIORITY_OR_OTHER||Treatment Contrast|-3.5|||<|0.0001||95.0|-4.84|-2.15||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.15|-4.84|<0.0001
73992159|NCT00781937|147530794|SUPERIORITY_OR_OTHER||Treatment Contrast|-2.05|||<|0.0001||95.0|-2.53|-1.57||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-1.57|-2.53|<0.0001
73992160|NCT00781937|147530795|SUPERIORITY_OR_OTHER||Treatment Contrast|2.35||||0.3689||95.0|-2.79|7.49||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||7.49|-2.79|0.3689
73992161|NCT00781937|147530796|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.1||||0.0053||95.0|-0.16|-0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.03|-0.16|0.0053
73992162|NCT00781937|147530797|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.38|||<|0.0001||95.0|-0.5|-0.26||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.26|-0.50|<0.0001
73992163|NCT00781937|147530798|SUPERIORITY_OR_OTHER||Treatment Contrast|-1.85||||0.0147||95.0|-3.34|-0.37||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.37|-3.34|0.0147
73992164|NCT00781937|147530799|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.27|||<|0.0001||95.0|-0.33|-0.21||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.21|-0.33|<0.0001
73992165|NCT03520075|147530850|SUPERIORITY||Geometric Least Squares Mean (Geo LSM)|27.8|||||TWO_SIDED|90.0|8.5|91.2|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||91.2|8.50|
73992166|NCT03520075|147530850|SUPERIORITY||Geo LSM|38.8|||||TWO_SIDED|90.0|11.4|132.0|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||132|11.4|
73992167|NCT03520075|147530850|SUPERIORITY||Geo LSM|58.9|||||TWO_SIDED|90.0|15.7|222.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||222|15.7|
73992168|NCT03520075|147530850|SUPERIORITY||Geo LSM|47.2|||||TWO_SIDED|90.0|20.7|108.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||108|20.7|
73992169|NCT03520075|147530851|SUPERIORITY||Geo LSM|18.1|||||TWO_SIDED|90.0|5.28|61.9|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||61.9|5.28|
73992170|NCT03520075|147530851|SUPERIORITY||Geo LSM|44.1|||||TWO_SIDED|90.0|8.32|234.0|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||234|8.32|
73992171|NCT03520075|147530851|SUPERIORITY||Geo LSM|58.7|||||TWO_SIDED|90.0|15.7|220.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||220|15.7|
73992172|NCT03520075|147530851|SUPERIORITY||Geo LSM|40.2|||||TWO_SIDED|90.0|14.3|113.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||113|14.3|
73992173|NCT03520075|147530852|SUPERIORITY||Geo LSM|17.5|||||TWO_SIDED|90.0|5.62|54.3|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||54.3|5.62|
73992174|NCT03520075|147530852|SUPERIORITY||Geo LSM|34.5|||||TWO_SIDED|90.0|12.0|99.4|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||99.4|12.0|
73992175|NCT03520075|147530852|SUPERIORITY||Geo LSM|72.6|||||TWO_SIDED|90.0|17.6|299.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||299|17.6|
73992176|NCT03520075|147530852|SUPERIORITY||Geo LSM|72.5|||||TWO_SIDED|90.0|29.1|181.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||181|29.1|
73992177|NCT03520075|147530853|SUPERIORITY||Hodges-Lehmann Estimator|-2.275||||0.0388671|TWO_SIDED|90.0|-5.216|-0.083|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% confidence interval (CI) was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||-0.0830|-5.2160|0.0388671
73992178|NCT03520075|147530853|SUPERIORITY||Hodges-Lehmann Estimator|1.45||||0.4795001|TWO_SIDED|90.0|-0.917|5.15|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||5.1500|-0.9170|0.4795001
73992179|NCT03520075|147530853|SUPERIORITY||Hodges-Lehmann Estimator|-0.45||||0.8272593|TWO_SIDED|90.0|-2.467|0.95|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||0.9500|-2.4670|0.8272593
73992180|NCT03520075|147530853|SUPERIORITY||Hodges-Lehmann Estimator|0.583||||0.5126908|TWO_SIDED|90.0|-6.45|3.5|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||3.5000|-6.4500|0.5126908
74035521|NCT04570657|147623930|SUPERIORITY||Odds Ratio (OR)|1.07||||0.84|TWO_SIDED|80.0|0.68|1.7|||Chi-squared|||||1.70|0.68|0.840
73876442|NCT02365649|147294818|SUPERIORITY||Adjusted risk difference from placebo|-2.4||||0.736|TWO_SIDED|95.0|-16.4|11.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||11.6|-16.4|0.736
73992181|NCT01013961|147530903|SUPERIORITY_OR_OTHER_LEGACY|||||||0.722|TWO_SIDED||||||Fisher Exact|||||||0.722
73992182|NCT01013961|147530904|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
73992183|NCT01375751|147530923|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.82|STANDARD_ERROR_OF_MEAN|3.92|<|0.001|TWO_SIDED|95.0|-51.56|-36.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference.|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.||-36.09|-51.56|<0.001
73992184|NCT01375751|147530923|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.36|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-64.06|-48.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.||-48.67|-64.06|<0.001
73992185|NCT01375751|147530924|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-79.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-51.4|-79.6|<0.001
73992186|NCT01375751|147530924|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-84.7|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-98.8|-70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-70.7|-98.8|<0.001
73992187|NCT01375751|147530925|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.79|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-49.32|-34.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-34.26|-49.32|<0.001
73992188|NCT01375751|147530925|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.46|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-60.95|-45.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-45.97|-60.95|<0.001
73992189|NCT01375751|147530926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.75|STANDARD_ERROR_OF_MEAN|3.55|<|0.001|TWO_SIDED|95.0|-41.77|-27.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-27.74|-41.77|<0.001
73876443|NCT02365649|147294819|SUPERIORITY||Adjusted risk difference from placebo|2.9||||0.276|TWO_SIDED|95.0|-2.3|8.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||8.1|-2.3|0.276
73876444|NCT02365649|147294819|SUPERIORITY||Adjusted risk difference from placebo|4.9||||0.195|TWO_SIDED|95.0|-2.5|12.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||12.4|-2.5|0.195
73992190|NCT01375751|147530926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.2|STANDARD_ERROR_OF_MEAN|3.53|<|0.001|TWO_SIDED|95.0|-53.18|-39.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-39.23|-53.18|<0.001
73992191|NCT01375751|147530927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.66|STANDARD_ERROR_OF_MEAN|3.72|<|0.001|TWO_SIDED|95.0|-44.01|-29.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placbo is the reference|||-29.32|-44.01|<0.001
73992192|NCT01375751|147530927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.01|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-52.32|-37.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-37.70|-52.32|<0.001
73876445|NCT02365649|147294819|SUPERIORITY||Adjusted risk difference from placebo|2.6||||0.355|TWO_SIDED|95.0|-2.9|8.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||8.0|-2.9|0.355
73876446|NCT02365649|147294819|SUPERIORITY||Adjusted risk difference from placebo|7.7||||0.099|TWO_SIDED|95.0|-1.5|16.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.8|-1.5|0.099
73992193|NCT01375751|147530928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.92|STANDARD_ERROR_OF_MEAN|3.45|<|0.001|TWO_SIDED|95.0|-40.72|-27.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-27.11|-40.72|<0.001
73992194|NCT01375751|147530928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.64|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|-51.41|-37.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-37.86|-51.41|<0.001
73992195|NCT02980523|147530929|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.002|||||||Chi-squared|||||||0.002
73992196|NCT02980523|147530930|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.372|||||||Chi-squared, Corrected|||||||0.372
73992197|NCT02980523|147530931|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.341|||||||Chi-squared, Corrected|||||||0.341
73992198|NCT02980523|147530932|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.001|||||||Chi-squared, Corrected|||||||0.001
73992199|NCT02980523|147530933|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.003|||||||Chi-squared, Corrected|||||||0.003
73992200|NCT02980523|147530934|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.216|||||||Chi-squared, Corrected|||||||0.216
73992201|NCT02980523|147530935|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.829|||||||Chi-squared, Corrected|||||||0.829
73992202|NCT00559377|147530937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.42|TWO_SIDED||||||Regression, Cox|||This outcome is for comparing FMISO Hypoxic Volume to overall survival||||.42
73992203|NCT00559377|147530937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.87|TWO_SIDED||||||Regression, Cox|||This outcome is for comparing FMISO T:Bmax to overall survival||||.87
73992204|NCT00559377|147530938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.58|TWO_SIDED||||||Regression, Cox|||This outcome is for comparison of FMISO Hypoxic Volume to disease-free survival||||.58
73992205|NCT00559377|147530938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED||||||Regression, Cox|||This outcome is for comarison of FMISO T:Bmax to progression-free survival||||.98
73992206|NCT00559377|147530939|SUPERIORITY_OR_OTHER||Spearman Correlation|0.004|||<|0.05|TWO_SIDED||||||Spearman Correlation|||The correlation between IHC values and FMISO uptake were analyzed using Spearman correlation where p values less than 0.05 were considered significant.||||<0.05
73992207|NCT00940875|147530943|SUPERIORITY_OR_OTHER||Difference in Response Rates|-3.3|||||TWO_SIDED|95.0|-17.5|10.9|||||The 95% CI for the difference of 2 rates was estimated using the Hauck-Anderson method.|||10.9|-17.5|
73992208|NCT00940875|147530944|SUPERIORITY_OR_OTHER|||||||0.4798|TWO_SIDED||||||Log Rank|||Difference between treatment groups in PFS||||0.4798
73992209|NCT00940875|147530944|SUPERIORITY_OR_OTHER||Hazard Ratio, log|1.3||||0.4805|TWO_SIDED|95.0|0.63|2.68|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), disease stage, histology, and smoking status.|||2.68|0.63|0.4805
73992210|NCT00940875|147530945|SUPERIORITY_OR_OTHER||Difference in Response Rates|-11.54|||||TWO_SIDED|95.0|-40.3|17.2|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 8||17.2|-40.3|
73992211|NCT00940875|147530945|SUPERIORITY_OR_OTHER||Difference in Response Rates|-13.46|||||TWO_SIDED|95.0|-36.0|9.0|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 16||9.0|-36.0|
73992212|NCT00940875|147530947|SUPERIORITY_OR_OTHER|||||||0.5393|TWO_SIDED||||||Log Rank|||Difference between treatment groups in OS||||0.5393
73992213|NCT00940875|147530947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.5399|TWO_SIDED|95.0|0.38|1.66|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by ECOG PS, disease stage, histology, and smoking status.|||1.66|0.38|0.5399
73992214|NCT05186311|147530981|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit (CAL).||||||||||||||||One hundred (100) participants (with paired numerical data) per each analyte provide \> 90% power to ensure that mean biases and confidence intervals are within the clinical acceptance limit (CAL), at medically relevant points, assuming no true bias between the tube types, residual standard deviation (SD) or coefficient of variation (CV) = CAL and collected data cover medically relevant points.|"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73992215|NCT05186311|147530982|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73992216|NCT05186311|147530983|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73876447|NCT02365649|147294819|SUPERIORITY||Adjusted risk difference from placebo|5.2||||0.185|TWO_SIDED|95.0|-2.5|12.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||12.9|-2.5|0.185
73876448|NCT02365649|147294820|SUPERIORITY||Adjusted risk difference from placebo|13.2||||0.05|TWO_SIDED|95.0|0.0|26.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.5|0.0|0.05
73876449|NCT02365649|147294820|SUPERIORITY||Adjusted risk difference from placebo|29.5||||0.001|TWO_SIDED|95.0|11.9|47.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||47.1|11.9|0.001
73876450|NCT02365649|147294820|SUPERIORITY||Adjusted risk difference from placebo|25.2||||0.003|TWO_SIDED|95.0|8.5|42.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||42.0|8.5|0.003
73876451|NCT02365649|147294820|SUPERIORITY||Adjusted risk difference from placebo|36.5|||<|0.001|TWO_SIDED|95.0|17.6|55.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||55.4|17.6|< 0.001
73876452|NCT02365649|147294820|SUPERIORITY||Adjusted risk difference from placebo|32.0|||<|0.001|TWO_SIDED|95.0|13.9|50.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.2|13.9|< 0.001
73992217|NCT05186311|147530984|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73992218|NCT05186311|147530985|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73876453|NCT02365649|147294821|SUPERIORITY||Adjusted risk difference from placebo|10.5||||0.243|TWO_SIDED|95.0|-7.2|28.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||28.2|-7.2|0.243
74009242|NCT01380730|147569259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.38|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-47.81|-38.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-38.94|-47.81|<0.001
73876454|NCT02365649|147294821|SUPERIORITY||Adjusted risk difference from placebo|29.1||||0.006|TWO_SIDED|95.0|8.3|49.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.9|8.3|0.006
73876455|NCT02365649|147294821|SUPERIORITY||Adjusted risk difference from placebo|24.2||||0.017|TWO_SIDED|95.0|4.4|44.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||44.1|4.4|0.017
73876456|NCT02365649|147294821|SUPERIORITY||Adjusted risk difference from placebo|36.5|||<|0.001|TWO_SIDED|95.0|14.8|58.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.1|14.8|< 0.001
73876457|NCT02365649|147294821|SUPERIORITY||Adjusted risk difference from placebo|36.8|||<|0.001|TWO_SIDED|95.0|15.2|58.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.3|15.2|< 0.001
73876458|NCT02365649|147294822|SUPERIORITY||Adjusted risk difference from placebo|10.5||||0.353|TWO_SIDED|95.0|-11.7|32.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.7|-11.7|0.353
73876459|NCT02365649|147294822|SUPERIORITY||Adjusted risk difference from placebo|22.7||||0.05|TWO_SIDED|95.0|0.0|45.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||45.5|0.0|0.05
73876460|NCT02365649|147294822|SUPERIORITY||Adjusted risk difference from placebo|12.5||||0.268|TWO_SIDED|95.0|-9.6|34.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.6|-9.6|0.268
73876461|NCT02365649|147294822|SUPERIORITY||Adjusted risk difference from placebo|28.0||||0.018|TWO_SIDED|95.0|4.8|51.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||51.2|4.8|0.018
73876462|NCT02365649|147294822|SUPERIORITY||Adjusted risk difference from placebo|14.9||||0.204|TWO_SIDED|95.0|-8.1|37.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.8|-8.1|0.204
73876463|NCT02365649|147294823|SUPERIORITY||Adjusted risk difference from placebo|10.0||||0.421|TWO_SIDED|95.0|-14.4|34.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.4|-14.4|0.421
73876464|NCT02365649|147294823|SUPERIORITY||Adjusted risk difference from placebo|11.5||||0.371|TWO_SIDED|95.0|-13.8|36.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||36.8|-13.8|0.371
73876465|NCT02365649|147294823|SUPERIORITY||Adjusted risk difference from placebo|9.2||||0.445|TWO_SIDED|95.0|-14.4|32.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.8|-14.4|0.445
73992219|NCT05186311|147530986|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73876466|NCT02365649|147294823|SUPERIORITY||Adjusted risk difference from placebo|19.5||||0.198|TWO_SIDED|95.0|-10.2|49.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.3|-10.2|0.198
73992220|NCT05186311|147530987|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73992221|NCT05186311|147530988|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73992222|NCT05186311|147530989|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73992223|NCT05186311|147530990|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73992224|NCT05186311|147530991|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73876467|NCT02365649|147294823|SUPERIORITY||Adjusted risk difference from placebo|5.0||||0.654|TWO_SIDED|95.0|-17.0|27.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||27.0|-17.0|0.654
73876468|NCT02365649|147294824|SUPERIORITY||Adjusted risk difference from placebo|18.7||||0.093|TWO_SIDED|95.0|-3.1|40.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40.5|-3.1|0.093
73992225|NCT05186311|147530992|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
73992226|NCT03178344|147531001|EQUIVALENCE|ANOVA||||||0.7||||||P value threshold is 0.05|ANOVA|||||||0.70
73992227|NCT03178344|147531002|EQUIVALENCE|ANOVA||||||0.71||||||P value threshold is 0.05.|ANOVA|||||||0.71
73992228|NCT03603639|147531029|SUPERIORITY||LS Mean difference|1.38|||||TWO_SIDED|90.0|-0.72|3.48||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||3.48|-0.72|
73992229|NCT03603639|147531029|SUPERIORITY||LS Mean difference|1.07|||||TWO_SIDED|90.0|-0.49|2.63||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.63|-0.49|
73992230|NCT03603639|147531030|SUPERIORITY||LS Mean Difference|0.39|||||TWO_SIDED|90.0|-0.75|1.54||||||In eye closure condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||1.54|-0.75|
73992231|NCT03603639|147531030|SUPERIORITY||LS Mean Difference|0.3|||||TWO_SIDED|90.0|-0.6|1.21||||||In eye closure condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||1.21|-0.60|
73992232|NCT03603639|147531030|SUPERIORITY||LS Mean Difference|1.62|||||TWO_SIDED|90.0|-1.16|4.39||||||In eyes closed condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||4.39|-1.16|
73992233|NCT03603639|147531030|SUPERIORITY||LS Mean Difference|1.05|||||TWO_SIDED|90.0|-0.89|2.98||||||In eyes closed condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.98|-0.89|
73992234|NCT03603639|147531030|SUPERIORITY||LS Mean Difference|0.21|||||TWO_SIDED|90.0|-1.87|2.28||||||In eyes open condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.28|-1.87|
73992235|NCT03603639|147531030|SUPERIORITY||LS Mean Difference|1.27|||||TWO_SIDED|90.0|-0.57|3.11||||||In eyes open condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||3.11|-0.57|
73992236|NCT00607672|147531042|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Mixed Models Analysis|||||||0.28
73992237|NCT00607672|147531043|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Mixed Models Analysis|||||||0.84
73992238|NCT00607672|147531044|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Kruskal-Wallis|||||||0.67
73992239|NCT00607672|147531045|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||||||0.73
73992240|NCT00607672|147531046|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||For plasma transfusion comparison. Ramipril and Candesartan versus placebo|Chi-squared|||||||0.04
73992241|NCT00607672|147531047|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||Comparison for norepinephrine use|Chi-squared|||||||0.27
73992242|NCT00607672|147531048|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Chi-squared|||||||0.62
73992243|NCT00607672|147531049|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Chi-squared|||||||0.51
73992244|NCT00607672|147531050|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Chi-squared|||||||0.87
73992245|NCT00607672|147531051|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Kruskal-Wallis|||||||0.04
73992246|NCT00607672|147531052|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Mixed Models Analysis|||||||0.69
73992247|NCT00607672|147531053|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|||||||0.97
73992248|NCT00607672|147531054|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Mixed Models Analysis|||||||0.46
73992249|NCT00443209|147531106|SUPERIORITY_OR_OTHER||Treatment Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-10.4|-2.6|||Miettenen and Nurminen method||Treatment Difference was compared using the Miettinen and Nurminen (MN) method.|||-2.6|-10.4|<0.001
73992250|NCT00443209|147531107|SUPERIORITY_OR_OTHER||Treatment Difference|-5.2|||||TWO_SIDED|95.0|-11.7|1.4|||||Treatment Difference was compared using the MN method.|||1.4|-11.7|
73992251|NCT00443209|147531108|SUPERIORITY_OR_OTHER||Treatment Difference|0.3|||||TWO_SIDED|95.0|-2.0|2.0|||||Treatment Difference was compared using the MN method.|||2.0|-2.0|
73992252|NCT00443209|147531110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|95.0|0.45|0.75|||||Based on mixed logistic regression model with a fixed effect term for treatment, baseline pain severity and a random effect term for participant, with the random effect following a normal distribution. An odds ratio \>1 is in favor of telcagepant.|||0.75|0.45|
73992253|NCT00409409|147531118|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|||||||0.0010
73992254|NCT00820664|147531119|SUPERIORITY_OR_OTHER||Least Squares Mean|0.49|||<|0.001||95.0|0.31|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.||||1.00|0.31|<0.001
73992255|NCT00820664|147531119|SUPERIORITY_OR_OTHER||Least Squares Mean|0.19||||0.032||95.0|0.02|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.||||1.00|0.02|0.032
73992256|NCT03635086|147531121|OTHER||Geometric Mean Ratio Estimate|1.1||||0.9998|TWO_SIDED|95.0|0.2|4.9|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||4.9|0.2|0.9998
73992257|NCT03635086|147531121|OTHER||Geometric Mean Ratio Estimate|1.5||||0.9345|TWO_SIDED|95.0|0.3|7.5|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||7.5|0.3|0.9345
73992258|NCT03635086|147531121|OTHER||Geometric Mean Ratio Estimate|0.5||||0.5836|TWO_SIDED|95.0|0.1|2.1|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||2.1|0.1|0.5836
73992259|NCT03635086|147531121|OTHER||Geometric Mean Ratio Estimate|2.4||||0.4844|TWO_SIDED|95.0|0.5|10.6|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||10.6|0.5|0.4844
73992260|NCT03635086|147531121|OTHER||Geometric Mean Ratio Estimate|1.4||||0.9725|TWO_SIDED|95.0|0.3|6.8|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||6.8|0.3|0.9725
74035522|NCT04570657|147623931|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.239|TWO_SIDED|80.0|0.8|2.0||One-sided p-value|Regression, Cox|Cox regression model with treatment group, background medication, geographic region, and ICS total daily dose as covariates.||||2.0|0.8|0.239
73992261|NCT03635086|147531121|OTHER||Geometric Mean Ratio Estimate|0.4||||0.4715|TWO_SIDED|95.0|0.1|1.9|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||1.9|0.1|0.4715
73992262|NCT03635086|147531121|OTHER||Geometric Mean Ratio Estimate|2.2||||0.5969|TWO_SIDED|95.0|0.5|9.6|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||9.6|0.5|0.5969
74035523|NCT04570657|147623931|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.461|TWO_SIDED|80.0|0.6|1.7||One-sided p-value|Regression, Cox|Cox regression model with treatment group, background medication, geographic region, and ICS total daily dose as covariates.||||1.7|0.6|0.461
73992263|NCT03635086|147531121|OTHER||Geometric Mean Ratio Estimate|0.3||||0.2043|TWO_SIDED|95.0|0.1|1.4|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||1.4|0.1|0.2043
73992264|NCT03635086|147531121|OTHER||Geometric Mean Ratio Estimate|1.5||||0.9388|TWO_SIDED|95.0|0.3|7.4|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||7.4|0.3|0.9388
73876469|NCT02365649|147294824|SUPERIORITY||Adjusted risk difference from placebo|13.5||||0.176|TWO_SIDED|95.0|-6.1|33.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.1|-6.1|0.176
73876470|NCT02365649|147294824|SUPERIORITY||Adjusted risk difference from placebo|35.9||||0.017|TWO_SIDED|95.0|6.3|65.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||65.5|6.3|0.017
73992265|NCT03635086|147531121|OTHER||Geometric Mean Ratio Estimate|5.2||||0.0251|TWO_SIDED|95.0|1.2|23.1|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||23.1|1.2|0.0251
73992266|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups|Geometric Mean Ratio Estimate|0.6||||0.5263|TWO_SIDED|95.0|0.2|1.6|||ANOVA|||Day 0||1.6|0.2|0.5263
73876471|NCT02365649|147294824|SUPERIORITY||Adjusted risk difference from placebo|26.1||||0.044|TWO_SIDED|95.0|0.7|51.5|||Cochran-Mantel-Haenszel|||||51.5|0.7|0.044
73992267|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
73992268|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
73992269|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
73992270|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.7||||0.55|TWO_SIDED|95.0|0.6|4.7|||ANOVA|||Day 0||4.7|0.6|0.5500
73992271|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.7||||0.5263|TWO_SIDED|95.0|0.6|4.6|||ANOVA|||Day 0||4.6|0.6|0.5263
73992272|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.5263|TWO_SIDED|95.0|0.6|4.6|||ANOVA|||Day 0||4.6|0.6|0.5263
73992273|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
73992274|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
73876472|NCT02365649|147294824|SUPERIORITY||Adjusted risk difference from placebo|13.1||||0.121|TWO_SIDED|95.0|-3.5|29.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.6|-3.5|0.121
73876473|NCT02365649|147294825|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.564|TWO_SIDED|95.0|-8.1|14.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||14.9|-8.1|0.564
73992275|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
73992276|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.5321|TWO_SIDED|95.0|0.2|1.7|||ANOVA|||Day 28||1.7|0.2|0.5321
73992277|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9983|TWO_SIDED|95.0|0.3|3.9|||ANOVA|||Day 28||3.9|0.3|0.9983
73992278|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8234|TWO_SIDED|95.0|0.2|2.1|||ANOVA|||Day 28||2.1|0.2|0.8234
73992279|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9882|TWO_SIDED|95.0|0.2|2.7|||ANOVA|||Day 28||2.7|0.2|0.9882
73992280|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.2||||0.3778|TWO_SIDED|95.0|0.6|7.6|||ANOVA|||Day 28||7.6|0.6|0.3778
73992281|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9878|TWO_SIDED|95.0|0.4|4.1|||ANOVA|||Day 28||4.1|0.4|0.9878
73992282|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.8213|TWO_SIDED|95.0|0.5|5.3|||ANOVA|||Day 28||5.3|0.5|0.8213
73992283|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.6716|TWO_SIDED|95.0|0.2|1.9|||ANOVA|||Day 28||1.9|0.2|0.6716
73992284|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.938|TWO_SIDED|95.0|0.2|2.5|||ANOVA|||Day 28||2.5|0.2|0.9380
73992285|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9777|TWO_SIDED|95.0|0.4|4.3|||ANOVA|||Day 28||4.3|0.4|0.9777
73992286|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9997|TWO_SIDED|95.0|0.3|4.7|||ANOVA|||Day 56||4.7|0.3|0.9997
73992287|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9287|TWO_SIDED|95.0|0.3|7.2|||ANOVA|||Day 56||7.2|0.3|0.9287
73992288|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.5598|TWO_SIDED|95.0|0.1|2.0|||ANOVA|||Day 56||2.0|0.1|0.5598
73992289|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|3.0||||0.2117|TWO_SIDED|95.0|0.7|13.1|||ANOVA|||Day 56||13.1|0.7|0.2117
73992290|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9699|TWO_SIDED|95.0|0.3|6.6|||ANOVA|||Day 56||6.6|0.3|0.9699
73992291|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.4||||0.446|TWO_SIDED|95.0|0.1|1.8|||ANOVA|||Day 56||1.8|0.1|0.4460
73992292|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.8||||0.292|TWO_SIDED|95.0|0.6|11.9|||ANOVA|||Day 56||11.9|0.6|0.2920
73992293|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.184|TWO_SIDED|95.0|0.1|1.4|||ANOVA|||Day 56||1.4|0.1|0.1840
73992294|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7229|TWO_SIDED|95.0|0.4|9.2|||ANOVA|||Day 56||9.2|0.4|0.7229
73992295|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|6.6||||0.0052|TWO_SIDED|95.0|1.5|28.6|||ANOVA|||Day 56||28.6|1.5|0.0052
73992296|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9777|TWO_SIDED|95.0|0.2|3.0|||ANOVA|||Day 182||3.0|0.2|0.9777
73992297|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9812|TWO_SIDED|95.0|0.3|5.3|||ANOVA|||Day 182||5.3|0.3|0.9812
73992298|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9979|TWO_SIDED|95.0|0.3|4.5|||ANOVA|||Day 182||4.5|0.3|0.9979
73992299|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.588|TWO_SIDED|95.0|0.5|7.9|||ANOVA|||Day 182||7.9|0.5|0.5880
73992300|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7973|TWO_SIDED|95.0|0.4|7.0|||ANOVA|||Day 182||7.0|0.4|0.7973
73992301|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.8992|TWO_SIDED|95.0|0.4|6.0|||ANOVA|||Day 182||6.0|0.4|0.8992
73992302|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.7||||0.2602|TWO_SIDED|95.0|0.7|10.4|||ANOVA|||Day 182||10.4|0.7|0.2602
73992303|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.9||||0.9991|TWO_SIDED|95.0|0.2|3.6|||ANOVA|||Day 182||3.6|0.2|0.9991
73992304|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9028|TWO_SIDED|95.0|0.4|6.2|||ANOVA|||Day 182||6.2|0.4|0.9028
73992305|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7761|TWO_SIDED|95.0|0.4|6.8|||ANOVA|||Day 182||6.8|0.4|0.7761
73992306|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.7833|TWO_SIDED|95.0|0.2|2.1|||ANOVA|||Day 365||2.1|0.2|0.7833
73992307|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9915|TWO_SIDED|95.0|0.2|2.9|||ANOVA|||Day 365||2.9|0.2|0.9915
74090019|NCT04285567|147733069|SUPERIORITY||Difference in Rates|31.63|||<|0.0001|TWO_SIDED|95.0|16.55|46.71|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||46.71|16.55|< .0001
73992308|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.9||||0.998|TWO_SIDED|95.0|0.3|3.0|||ANOVA|||Day 365||3.0|0.3|0.9980
73992309|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.909|TWO_SIDED|95.0|0.4|4.9|||ANOVA|||Day 365||4.9|0.4|0.9090
73992310|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9651|TWO_SIDED|95.0|0.4|4.7|||ANOVA|||Day 365||4.7|0.4|0.9651
73992311|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9112|TWO_SIDED|95.0|0.4|4.7|||ANOVA|||Day 365||4.7|0.4|0.9112
73992312|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.4||||0.257|TWO_SIDED|95.0|0.7|7.8|||ANOVA|||Day 365||7.8|0.7|0.2570
73992313|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9999|TWO_SIDED|95.0|0.3|3.8|||ANOVA|||Day 365||3.8|0.3|0.9999
73992314|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.8||||0.6953|TWO_SIDED|95.0|0.5|6.2|||ANOVA|||Day 365||6.2|0.5|0.6953
73992315|NCT03635086|147531124|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7523|TWO_SIDED|95.0|0.5|5.4|||ANOVA|||Day 365||5.4|0.5|0.7523
73992316|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups|Geometric Mean Ratio Estimate|0.5||||0.5263|TWO_SIDED|95.0|0.1|1.7|||ANOVA|||Day 0||1.7|0.1|0.5263
73992317|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
73992318|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
73992319|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
73992320|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|2.0||||0.55|TWO_SIDED|95.0|0.6|7.0|||ANOVA|||Day 0||7.0|0.6|0.5500
73992321|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|2.0||||0.5263|TWO_SIDED|95.0|0.6|6.7|||ANOVA|||Day 0||6.7|0.6|0.5263
73992322|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.5263|TWO_SIDED|95.0|0.6|6.7|||ANOVA|||Day 0||6.7|0.6|0.5263
73992323|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
73992324|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
73992325|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
73992326|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.7708|TWO_SIDED|95.0|0.1|2.4|||ANOVA|||Day 28||2.4|0.1|0.7708
73992327|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9966|TWO_SIDED|95.0|0.3|5.4|||ANOVA|||Day 28||5.4|0.3|0.9966
73992328|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.9503|TWO_SIDED|95.0|0.2|3.0|||ANOVA|||Day 28||3.0|0.2|0.9503
73992329|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.9791|TWO_SIDED|95.0|0.2|3.2|||ANOVA|||Day 28||3.2|0.2|0.9791
73992330|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.2||||0.5739|TWO_SIDED|95.0|0.5|9.8|||ANOVA|||Day 28||9.8|0.5|0.5739
73992331|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9918|TWO_SIDED|95.0|0.3|5.4|||ANOVA|||Day 28||5.4|0.3|0.9918
73992332|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9748|TWO_SIDED|95.0|0.3|5.9|||ANOVA|||Day 28||5.9|0.3|0.9748
73992333|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.827|TWO_SIDED|95.0|0.1|2.6|||ANOVA|||Day 28||2.6|0.1|0.8270
73992334|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.893|TWO_SIDED|95.0|0.1|2.8|||ANOVA|||Day 28||2.8|0.1|0.8930
73992335|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9999|TWO_SIDED|95.0|0.3|4.7|||ANOVA|||Day 28||4.7|0.3|0.9999
73992336|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.9105|TWO_SIDED|95.0|0.1|3.2|||ANOVA|||Day 56||3.2|0.1|0.9105
73992337|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 56||5.5|0.2|1.0000
73876474|NCT02365649|147294825|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.584|TWO_SIDED|95.0|-8.8|15.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.7|-8.8|0.584
73992338|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.3047|TWO_SIDED|95.0|0.1|1.7|||ANOVA|||Day 56||1.7|0.1|0.3047
73992339|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|5.5||||0.0423|TWO_SIDED|95.0|1.0|29.2|||ANOVA|||Day 56||29.2|1.0|0.0423
73992340|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.9213|TWO_SIDED|95.0|0.3|9.1|||ANOVA|||Day 56||9.1|0.3|0.9213
73992341|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.8092|TWO_SIDED|95.0|0.1|2.8|||ANOVA|||Day 56||2.8|0.1|0.8092
73992342|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|9.1||||0.004|TWO_SIDED|95.0|1.7|48.5|||ANOVA|||Day 56||48.5|1.7|0.0040
73992343|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.3347|TWO_SIDED|95.0|0.1|1.8|||ANOVA|||Day 56||1.8|0.1|0.3347
73992344|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|5.6||||0.0488|TWO_SIDED|95.0|1.0|30.7|||ANOVA|||Day 56||30.7|1.0|0.0488
73992345|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|17.4||||0.0001|TWO_SIDED|95.0|3.3|92.2|||ANOVA|||Day 56||92.2|3.3|0.0001
73992346|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8831|TWO_SIDED|95.0|0.1|3.0|||ANOVA|||Day 182||3.0|0.1|0.8831
73992347|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.2|||ANOVA|||Day 182||5.2|0.2|1.0000
73992348|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8916|TWO_SIDED|95.0|0.1|3.1|||ANOVA|||Day 182||3.1|0.1|0.8916
73992349|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.9||||0.794|TWO_SIDED|95.0|0.4|9.9|||ANOVA|||Day 182||9.9|0.4|0.7940
73876475|NCT02365649|147294825|SUPERIORITY||Adjusted risk difference from placebo|8.7||||0.326|TWO_SIDED|95.0|-8.7|26.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.1|-8.7|0.326
73876476|NCT02365649|147294826|SUPERIORITY||Adjusted risk difference from placebo|12.2||||0.195|TWO_SIDED|95.0|-6.2|30.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||30.7|-6.2|0.195
73876477|NCT02365649|147294826|SUPERIORITY||Adjusted risk difference from placebo|17.9||||0.116|TWO_SIDED|95.0|-4.4|40.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40.1|-4.4|0.116
73992350|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.9169|TWO_SIDED|95.0|0.3|8.9|||ANOVA|||Day 182||8.9|0.3|0.9169
73992351|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.2|||ANOVA|||Day 182||5.2|0.2|1.0000
73992352|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|3.3||||0.2563|TWO_SIDED|95.0|0.6|17.1|||ANOVA|||Day 182||17.1|0.6|0.2563
73992353|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.9237|TWO_SIDED|95.0|0.1|3.3|||ANOVA|||Day 182||3.3|0.1|0.9237
73992354|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7708|TWO_SIDED|95.0|0.4|10.8|||ANOVA|||Day 182||10.8|0.4|0.7708
74035524|NCT04570657|147623932|SUPERIORITY||Rate ratio|0.87||||0.346|TWO_SIDED|80.0|0.56|1.36||One-sided p-value|Negative binomial regression|||||1.36|0.56|0.346
73992355|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|3.3||||0.2661|TWO_SIDED|95.0|0.6|16.9|||ANOVA|||Day 182||16.9|0.6|0.2661
73992356|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.7614|TWO_SIDED|95.0|0.1|2.6|||ANOVA|||Day 365||2.6|0.1|0.7614
73992357|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9905|TWO_SIDED|95.0|0.1|4.3|||ANOVA|||Day 365||4.3|0.1|0.9905
74035525|NCT04570657|147623932|SUPERIORITY||Rate ratio|0.7||||0.166|TWO_SIDED|80.0|0.43|1.12||One-sided p-value|Negative binomial regression|||||1.12|0.43|0.166
73876478|NCT02365649|147294826|SUPERIORITY||Adjusted risk difference from placebo|12.8||||0.178|TWO_SIDED|95.0|-5.8|31.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||31.5|-5.8|0.178
73876479|NCT02365649|147294826|SUPERIORITY||Adjusted risk difference from placebo|30.4||||0.031|TWO_SIDED|95.0|2.8|58.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.0|2.8|0.031
73876480|NCT02365649|147294826|SUPERIORITY||Adjusted risk difference from placebo|13.1||||0.121|TWO_SIDED|95.0|-3.5|29.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.6|-3.5|0.121
73876481|NCT02365649|147294827|SUPERIORITY||Adjusted risk difference from placebo|6.8||||0.392|TWO_SIDED|95.0|-8.7|22.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.2|-8.7|0.392
73992358|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.933|TWO_SIDED|95.0|0.1|3.3|||ANOVA|||Day 365||3.3|0.1|0.9330
73992359|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9945|TWO_SIDED|95.0|0.2|6.7|||ANOVA|||Day 365||6.7|0.2|0.9945
73992360|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9599|TWO_SIDED|95.0|0.3|8.4|||ANOVA|||Day 365||8.4|0.3|0.9599
73992361|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9942|TWO_SIDED|95.0|0.2|6.4|||ANOVA|||Day 365||6.4|0.2|0.9942
73992362|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.5||||0.4932|TWO_SIDED|95.0|0.5|12.9|||ANOVA|||Day 365||12.9|0.5|0.4932
73992363|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9983|TWO_SIDED|95.0|0.2|4.6|||ANOVA|||Day 365||4.6|0.2|0.9983
73992364|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.9112|TWO_SIDED|95.0|0.3|9.3|||ANOVA|||Day 365||9.3|0.3|0.9112
74035526|NCT04570657|147623933|SUPERIORITY||Geometric LS mean ratio|0.869||||0.029|TWO_SIDED|80.0|0.791|0.956||One-sided p-value|MMRM|||||0.956|0.791|0.029
74035527|NCT04570657|147623933|SUPERIORITY||Geometric LS mean ratio|0.879||||0.04|TWO_SIDED|80.0|0.8|0.966||One-sided p-value|MMRM|||||0.966|0.800|0.040
74035528|NCT04570657|147623934|SUPERIORITY||LS mean difference|0.023||||0.385|TWO_SIDED|80.0|-0.078|0.124||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose A - Placebo|1 Exacerbation in Last 12 Months||0.124|-0.078|0.385
74035529|NCT04570657|147623934|SUPERIORITY||LS mean difference|-0.123||||0.06|TWO_SIDED|80.0|-0.224|-0.022||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose B - Placebo|1 Exacerbation in Last 12 Months||-0.022|-0.224|0.060
73992365|NCT03635086|147531133|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7431|TWO_SIDED|95.0|0.4|10.2|||ANOVA|||Day 365||10.2|0.4|0.7431
73992366|NCT00825305|147531149|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 14 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean|-0.2|||||TWO_SIDED|95.0|-0.81|0.4|||ANOVA||Ratio of log2 mean (Zagreb/Essen) on day 14|||0.4|-0.81|
73992367|NCT00825305|147531150|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 7 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day7)|-0.21|||||TWO_SIDED|95.0|-0.77|0.35|||ANOVA||Ratio of log2 means (Zagreb/Essen) on day 7|||0.35|-0.77|
73992368|NCT00825305|147531150|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 42 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day 42)|-0.07|||||TWO_SIDED|95.0|-0.72|0.58|||ANOVA||Ratio of log2 mean (Zagreb/(Essen) on day 42|||0.58|-0.72|
73992369|NCT03617289|147531153|SUPERIORITY|||||||0.771||||||Threshold for statistical significance set at p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.771
73992370|NCT03617289|147531154|SUPERIORITY||||||<|0.046||||||Threshold for statistical significance was set at p\<0.05|Chi-squared|||||||<0.046
73992371|NCT02165826|147531180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.017|TWO_SIDED|95.0|0.47|0.93||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||0.93|0.47|0.017
73992372|NCT02165826|147531180|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.68|||||TWO_SIDED|95.0|0.51|0.92|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.||0.92|0.51|
73992373|NCT02165826|147531180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.114|TWO_SIDED|95.0|0.55|1.07||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||1.07|0.55|0.114
73992374|NCT02165826|147531180|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.77|||||TWO_SIDED|95.0|0.58|1.02|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.||1.02|0.58|
73992375|NCT02165826|147531181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.001|TWO_SIDED|95.0|0.47|0.83||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||0.83|0.47|0.001
73992376|NCT02165826|147531181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.091|TWO_SIDED|95.0|0.59|1.04||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||1.04|0.59|0.091
73992377|NCT01936467|147531200|OTHER||Sensitivity|93.7|||||TWO_SIDED|||||||||||||
73992378|NCT01936467|147531200|OTHER||Specificity|100.0|||||TWO_SIDED|||||||||||||
73992379|NCT01936467|147531201|OTHER||Sensitivity|88.6|||||TWO_SIDED|||||||||||||
73992380|NCT01936467|147531201|OTHER||Specificity|100.0|||||TWO_SIDED|||||||||||||
73992381|NCT01936467|147531202|OTHER|||||||0.47|||||||Chi-squared|||||||0.47
73992382|NCT01936467|147531203|SUPERIORITY_OR_OTHER|||||||0.71|||||||Chi-squared|||||||0.71
74090020|NCT04285567|147733070|SUPERIORITY||Difference in Response Rates|9.68||||0.1119|TWO_SIDED|95.0|-2.05|21.41|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||21.41|-2.05|0.1119
73992383|NCT01936467|147531204|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||||||0.15
73992384|NCT01936467|147531205|SUPERIORITY_OR_OTHER|||||||0.46|||||||Chi-squared|||||||0.46
73992385|NCT00349466|147531213|SUPERIORITY|||||||0.027|||||||ANCOVA|||||||0.027
73992386|NCT00349466|147531214|SUPERIORITY|||||||0.083|||||||ANCOVA|||||||0.083
73992387|NCT00349466|147531215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|TWO_SIDED|95.0|||||Fisher Exact|||||||0.028
73992388|NCT00349466|147531216|SUPERIORITY|||||||0.655|||||||Fisher Exact|||||||0.655
73992389|NCT00349466|147531217|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.387
73992390|NCT00349466|147531218|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
73992391|NCT00349466|147531219|SUPERIORITY|||||||0.807|||||||ANCOVA|||||||.807
73992392|NCT01952847|147531261|OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
73992393|NCT01952847|147531262|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
73992394|NCT01952847|147531265|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73992395|NCT01952847|147531266|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
73992396|NCT01952847|147531267|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
73992397|NCT01952847|147531268|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73992398|NCT01952847|147531269|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
73992399|NCT01952847|147531270|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
73992400|NCT01952847|147531271|SUPERIORITY|||||||0.57|||||||Log Rank|||||||0.57
73992401|NCT01952847|147531275|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
73992402|NCT01952847|147531276|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
73992403|NCT05146206|147531279|OTHER||||||<|0.001|||||||ANOVA|||||||<.001
73992404|NCT05146206|147531280|OTHER||||||<|0.001|||||||MANOVA|||||||<0.001
73992405|NCT02577003|147531281|SUPERIORITY||Difference in least squares means|-0.77|||<|0.001|TWO_SIDED|95.0|-0.98|-0.57|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-0.57|-0.98|<0.001
73992406|NCT02577003|147531284|SUPERIORITY||Difference in least squares means|-28.1|||<|0.001|TWO_SIDED|95.0|-34.8|-21.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-21.5|-34.8|<0.001
73992407|NCT02577003|147531285|SUPERIORITY||Difference in least squares means|-48.5|||<|0.001|TWO_SIDED|95.0|-59.6|-37.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-37.5|-59.6|<0.001
73876482|NCT02365649|147294827|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.584|TWO_SIDED|95.0|-8.8|15.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.7|-8.8|0.584
73992408|NCT02577003|147531286|SUPERIORITY||Difference in least squares means|-84.6|||<|0.001|TWO_SIDED|95.0|-102.6|-66.6|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-66.6|-102.6|<0.001
73992409|NCT02577003|147531287|SUPERIORITY||Difference in least squares means|-1.8|||<|0.001|TWO_SIDED|95.0|-2.5|-1.1|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-1.1|-2.5|<0.001
73992410|NCT03334253|147531290|SUPERIORITY|"The following assumptions were used in the power calculation:~* 2:1 randomization~* treatment group difference of 0.50D~* standard deviation of 0.80D~* type 1 error of 5% (2-sided)~* up to 10% loss to follow up"|Adjusted mean difference|-0.02|||||TWO_SIDED|95.0|-0.19|0.15|||||Atropine - Placebo Adjusted mean difference, adjusting for baseline refractive error, age, iris color (brown vs. not brown), and race (East Asian vs. non-East Asian).|Null Hypothesis: no difference in mean change in SER from baseline to 24 months between the atropine and placebo groups||0.15|-0.19|
73992411|NCT03334253|147531291|SUPERIORITY|"The following assumptions were used in the power calculation:~* 2:1 randomization~* treatment group difference of 0.50D~* standard deviation of 0.80D~* type 1 error of 5% (2-sided)~* up to 10% loss to follow up"|Adjusted mean difference|-0.04|||||TWO_SIDED|95.0|-0.25|0.17|||||Atropine-Placebo Adjusted mean difference, adjusting for baseline refractive error, age, iris color (brown vs. not brown), and race (East Asian vs. non-East Asian).|Null Hypothesis: no difference in mean change in SER from baseline to 24 months between the atropine and placebo groups||0.17|-0.25|
73992412|NCT00203047|147531292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.11820976||0.8023|TWO_SIDED|95.0|-0.26|0.2|||ANCOVA|||||0.20|-0.26|0.8023
73992413|NCT00340704|147531316|SUPERIORITY_OR_OTHER||Slope|1.0039|STANDARD_ERROR_OF_MEAN|0.1725||||95.0|0.6499|1.3579|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality for Cmax,ss was explored based on the regression model.||1.3579|0.6499|
73992414|NCT00340704|147531320|SUPERIORITY_OR_OTHER||Slope|0.98|STANDARD_ERROR_OF_MEAN|0.1884||||95.0|0.5934|1.3666|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of the slope.|Dose proportionality for AUCτ,ss was explored based on the regression model.||1.3666|0.5934|
73992415|NCT00121667|147531328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.92|-0.53||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.53|-0.92|<.0001
73992416|NCT00121667|147531328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-1.02|-0.63||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.63|-1.02|<.0001
73876483|NCT02365649|147294827|SUPERIORITY||Adjusted risk difference from placebo|13.0||||0.199|TWO_SIDED|95.0|-6.8|32.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.9|-6.8|0.199
73992417|NCT00121667|147531328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.52||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.52|-0.91|<.0001
73992418|NCT00121667|147531329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.55|STANDARD_ERROR_OF_MEAN|3.56|<|0.0001|TWO_SIDED|95.0|-22.55|-8.55||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-8.55|-22.55|<.0001
73992419|NCT00121667|147531329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.28|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-30.29|-16.27||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-16.27|-30.29|<.0001
73992420|NCT00121667|147531329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.74|STANDARD_ERROR_OF_MEAN|3.6|<|0.0001|TWO_SIDED|95.0|-28.81|-14.68||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-14.68|-28.81|<.0001
73992421|NCT00121667|147531330|SUPERIORITY_OR_OTHER||Difference in Proportions|20.5|||<|0.0001|TWO_SIDED|95.0|10.6|30.5||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||30.5|10.6|<.0001
73992422|NCT00121667|147531330|SUPERIORITY_OR_OTHER||Difference in Proportions|27.0|||<|0.0001|TWO_SIDED|95.0|17.0|36.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||36.7|17.0|<.0001
73992423|NCT00121667|147531330|SUPERIORITY_OR_OTHER||Difference in Proportions|27.9|||<|0.0001|TWO_SIDED|95.0|17.7|37.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||37.7|17.7|<.0001
73992424|NCT00121667|147531331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5599.0|STANDARD_ERROR_OF_MEAN|1168.2|<|0.0001|TWO_SIDED|95.0|-7894.0|-3305.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-3305|-7894|<.0001
73992425|NCT00121667|147531331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6294.0|STANDARD_ERROR_OF_MEAN|1176.8|<|0.0001|TWO_SIDED|95.0|-8606.0|-3983.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-3983|-8606|<.0001
73992426|NCT00121667|147531331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4845.0|STANDARD_ERROR_OF_MEAN|1175.1|<|0.0001|TWO_SIDED|95.0|-7153.0|-2537.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-2537|-7153|<.0001
73992427|NCT01453023|147531363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||||TWO_SIDED|95.0|-8.8|0.4|||||Day 1 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||0.4|-8.8|
73992428|NCT01453023|147531363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-1.1|8.5|||||Day 14 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||8.5|-1.1|
73992429|NCT01453023|147531364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-4.4|6.7|||||Day 1 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||6.7|-4.4|
73992430|NCT01453023|147531364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-6.0|5.5|||||Day 14 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||5.5|-6.0|
73992431|NCT04547023|147531407|OTHER||Mean Difference (Final Values)|18.7||||0.002|TWO_SIDED|95.0|7.2|30.1|||Fisher Exact|||||30.1|7.2|0.002
73992432|NCT01262092|147531435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2887||||0.035||95.0||||p values \<0.05 considered statistically significant|Mixed Models Analysis|Used proc GLIMMIX to model group by time (6 study visits)||"test null hypothesis that gbp and pla did not differ in terms of opioid-positive urines during the buprenorphine detox.~For the analysis, data from 2 participants in the GBP groups were excluded due to evidence of medication diversion (N=1) and not being maintained on the 1600 mg/day dose of GBP (N=1)."||||0.035
73992433|NCT03784820|147531436|SUPERIORITY||Odds Ratio (OR)|0.35||||0.36|TWO_SIDED|95.0|0.04|3.27||Comparison of Patients at Post (T2) \[CBT-E is the reference\]|Mixed Models Analysis|||||3.27|0.04|0.36
73992434|NCT03784820|147531436|SUPERIORITY||Odds Ratio (OR)|0.29||||0.38|TWO_SIDED|95.0|0.02|4.6||Comparison of Patients at 3 Month Fup (T3) \[CBT-E is the reference\]|Mixed Models Analysis|||||4.60|0.02|0.38
73992435|NCT03784820|147531436|SUPERIORITY||Odds Ratio (OR)|2.2||||0.54|TWO_SIDED|95.0|0.18|27.39||Comparison of Patients at 6 Month Fup (T4) \[CBT-E is the reference\]|Mixed Models Analysis|||||27.39|0.18|0.54
73992436|NCT03784820|147531437|SUPERIORITY||LS mean difference|0.51||||0.52|TWO_SIDED|95.0|-1.06|2.09||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||2.09|-1.06|0.52
73992437|NCT03784820|147531437|SUPERIORITY||LS mean difference|0.04||||0.97|TWO_SIDED|95.0|-1.99|2.07||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||2.07|-1.99|0.97
73992438|NCT03784820|147531437|SUPERIORITY||LS mean difference|0.62||||0.59|TWO_SIDED|95.0|-1.66|2.89||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||2.89|-1.66|0.59
73992439|NCT03784820|147531438|SUPERIORITY||LS mean difference|0.05||||0.86|TWO_SIDED|95.0|-0.45|0.54||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||0.54|-0.45|0.86
73992440|NCT03784820|147531438|SUPERIORITY||LS mean difference|0.3||||0.44|TWO_SIDED|95.0|-0.46|1.06||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||1.06|-0.46|0.44
73992441|NCT03784820|147531438|SUPERIORITY||LS mean difference|0.31||||0.36|TWO_SIDED|95.0|-0.36|0.98||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||0.98|-0.36|0.36
73992442|NCT03784820|147531439|SUPERIORITY||LS mean difference|2.47||||0.33|TWO_SIDED|95.0|-2.54|7.49||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||7.49|-2.54|0.33
73992443|NCT03784820|147531439|SUPERIORITY||LS mean difference|2.18||||0.46|TWO_SIDED|95.0|-3.59|7.95||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||7.95|-3.59|0.46
73992444|NCT03784820|147531439|SUPERIORITY||LS mean difference|3.83||||0.27|TWO_SIDED|95.0|-2.94|10.6||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||10.60|-2.94|0.27
73876484|NCT02365649|147294827|SUPERIORITY||Adjusted risk difference from placebo|6.9||||0.439|TWO_SIDED|95.0|-10.6|24.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||24.5|-10.6|0.439
73992445|NCT03784820|147531440|SUPERIORITY||LS mean difference|1.06||||0.62|TWO_SIDED|95.0|-3.14|5.25||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||5.25|-3.14|0.62
73992446|NCT03784820|147531440|SUPERIORITY||LS mean difference|1.83||||0.54|TWO_SIDED|95.0|-4.07|7.73||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||7.73|-4.07|0.54
73992447|NCT03784820|147531441|SUPERIORITY||LS mean difference|4.8||||0.1|TWO_SIDED|95.0|-0.91|10.51||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||10.51|-0.91|0.10
73992448|NCT03784820|147531441|SUPERIORITY||LS mean difference|1.08||||0.76|TWO_SIDED|95.0|-5.97|8.13||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||8.13|-5.97|0.76
73992449|NCT03784820|147531441|SUPERIORITY||LS mean difference|3.26||||0.23|TWO_SIDED|95.0|-2.03|8.55||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||8.55|-2.03|0.23
73992450|NCT03784820|147531441|SUPERIORITY||LS mean difference|-0.25||||0.94|TWO_SIDED|95.0|-6.63|6.14||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||6.14|-6.63|0.94
73992451|NCT03784820|147531441|SUPERIORITY||LS mean difference|-1.46||||0.68|TWO_SIDED|95.0|-8.38|5.46||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||5.46|-8.38|0.68
73992452|NCT03784820|147531441|SUPERIORITY||LS mean difference|-0.61||||0.89|TWO_SIDED|95.0|-9.06|7.84||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||7.84|-9.06|0.89
73992453|NCT03784820|147531442|SUPERIORITY||LS mean difference|-0.41||||0.91|TWO_SIDED|95.0|-7.61|6.79||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.79|-7.61|0.91
73992454|NCT03784820|147531442|SUPERIORITY||LS mean difference|4.72||||0.2|TWO_SIDED|95.0|-2.49|11.93||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||11.93|-2.49|0.20
73992455|NCT03784820|147531442|SUPERIORITY||LS mean difference|4.78||||0.14|TWO_SIDED|95.0|-1.63|11.2||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||11.20|-1.63|0.14
73992456|NCT03784820|147531442|SUPERIORITY||LS mean difference|3.86||||0.25|TWO_SIDED|95.0|-2.76|10.49||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||10.49|-2.76|0.25
73992457|NCT03784820|147531442|SUPERIORITY||LS mean difference|4.22||||0.14|TWO_SIDED|95.0|-1.45|9.89||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||9.89|-1.45|0.14
73992458|NCT03784820|147531442|SUPERIORITY||LS mean difference|3.15||||0.28|TWO_SIDED|95.0|-2.58|8.87||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||8.87|-2.58|0.28
73992459|NCT03784820|147531443|SUPERIORITY||LS mean difference|1.73||||0.85|TWO_SIDED|95.0|-16.73|20.19||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||20.19|-16.73|0.85
73992460|NCT03784820|147531443|SUPERIORITY||LS mean difference|7.94||||0.47|TWO_SIDED|95.0|-13.59|29.48||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||29.48|-13.59|0.47
73992461|NCT03784820|147531443|SUPERIORITY||LS mean difference|9.79||||0.37|TWO_SIDED|95.0|-11.5|31.08||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||31.08|-11.50|0.37
73992462|NCT03784820|147531443|SUPERIORITY||LS mean difference|0.36||||0.97|TWO_SIDED|95.0|-19.31|20.03||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||20.03|-19.31|0.97
73992463|NCT03784820|147531443|SUPERIORITY||LS mean difference|-5.88||||0.52|TWO_SIDED|95.0|-23.85|12.09||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||12.09|-23.85|0.52
73992464|NCT03784820|147531443|SUPERIORITY||LS mean difference|-3.55||||0.68|TWO_SIDED|95.0|-20.33|13.23||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||13.23|-20.33|0.68
73992465|NCT03784820|147531444|SUPERIORITY||LS mean difference|-0.27||||0.91|TWO_SIDED|95.0|-5.02|4.47||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||4.47|-5.02|0.91
73992466|NCT03784820|147531444|SUPERIORITY||LS mean difference|4.73||||0.07|TWO_SIDED|95.0|-0.36|9.81||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||9.81|-0.36|0.07
73992467|NCT03784820|147531444|SUPERIORITY||LS mean difference|1.75||||0.65|TWO_SIDED|95.0|-5.73|9.23||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||9.23|-5.73|0.65
73992468|NCT03784820|147531444|SUPERIORITY||LS mean difference|-2.05||||0.52|TWO_SIDED|95.0|-8.21|4.12|||Mixed Models Analysis|||Comparison of Partners at Post (T2)||4.12|-8.21|0.52
73992469|NCT03784820|147531444|SUPERIORITY||LS mean difference|-6.62||||0.07|TWO_SIDED|95.0|-13.74|0.51||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||0.51|-13.74|0.07
73992470|NCT03784820|147531444|SUPERIORITY||LS mean difference|-6.64||||0.03|TWO_SIDED|95.0|-12.73|-0.56||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||-0.56|-12.73|0.03
73992471|NCT03784820|147531445|SUPERIORITY||LS mean difference|0.88||||0.9|TWO_SIDED|95.0|-13.43|15.19||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||15.19|-13.43|0.90
73992472|NCT03784820|147531445|SUPERIORITY||LS mean difference|-0.64||||0.95|TWO_SIDED|95.0|-18.95|17.66||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||17.66|-18.95|0.95
73992473|NCT03784820|147531445|SUPERIORITY||LS mean difference|1.37||||0.89|TWO_SIDED|95.0|-17.17|19.9||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||19.90|-17.17|0.89
73992474|NCT03784820|147531445|SUPERIORITY||LS mean difference|5.81||||0.39|TWO_SIDED|95.0|-7.37|18.98|||Mixed Models Analysis|||Comparison of Partners at Post (T2)||18.98|-7.37|0.39
73992475|NCT03784820|147531445|SUPERIORITY||LS mean difference|6.29||||0.36|TWO_SIDED|95.0|-7.26|19.84||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||19.84|-7.26|0.36
73992476|NCT03784820|147531445|SUPERIORITY||LS mean difference|-1.55||||0.87|TWO_SIDED|95.0|-20.0|16.91||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||16.91|-20.00|0.87
73992477|NCT03784820|147531446|SUPERIORITY||LS mean difference|0.27||||0.84|TWO_SIDED|95.0|-2.29|2.83||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||2.83|-2.29|0.84
73992478|NCT03784820|147531446|SUPERIORITY||LS mean difference|-0.82||||0.57|TWO_SIDED|95.0|-3.66|2.01||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||2.01|-3.66|0.57
73992479|NCT03784820|147531446|SUPERIORITY||LS mean difference|0.6||||0.67|TWO_SIDED|95.0|-2.15|3.35||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||3.35|-2.15|0.67
73992480|NCT03784820|147531446|SUPERIORITY||LS mean difference|0.46||||0.63|TWO_SIDED|95.0|-1.43|2.35||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.35|-1.43|0.63
73992481|NCT03784820|147531446|SUPERIORITY||LS mean difference|1.44||||0.21|TWO_SIDED|95.0|-0.82|3.7||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||3.70|-0.82|0.21
73992482|NCT03784820|147531446|SUPERIORITY||LS mean difference|1.07||||0.34|TWO_SIDED|95.0|-1.14|3.28||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||3.28|-1.14|0.34
73992483|NCT03784820|147531447|SUPERIORITY||LS mean difference|-3.42||||0.5|TWO_SIDED|95.0|-13.36|6.52||Demand/Withdraw score: Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.52|-13.36|0.50
73992484|NCT03784820|147531447|SUPERIORITY||LS mean difference|-0.47||||0.89|TWO_SIDED|95.0|-7.49|6.54||Demand/Withdraw Score: Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||6.54|-7.49|0.89
73992485|NCT03784820|147531447|SUPERIORITY||LS mean difference|-0.63||||0.86|TWO_SIDED|95.0|-7.56|6.3||Demand/Withdraw Score: Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||6.30|-7.56|0.86
73992486|NCT03784820|147531447|SUPERIORITY||LS mean difference|2.55||||0.25|TWO_SIDED|95.0|-1.83|6.93||Constructive Communication Score: Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.93|-1.83|0.25
73992487|NCT03784820|147531447|SUPERIORITY||LS mean difference|2.05||||0.56|TWO_SIDED|95.0|-4.83|8.92||Constructive Communication Score: Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||8.92|-4.83|0.56
73992488|NCT03784820|147531447|SUPERIORITY||LS mean difference|3.13||||0.34|TWO_SIDED|95.0|-3.27|9.54||Constructive Communication Score: Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||9.54|-3.27|0.34
73992489|NCT03784820|147531447|SUPERIORITY||LS mean difference|-10.24||||0.02|TWO_SIDED|95.0|-19.05|-1.42||Demand/Withdraw score: Comparison of Partners at Post (T2)|Mixed Models Analysis|||||-1.42|-19.05|0.02
74090021|NCT04285567|147733071|SUPERIORITY||Difference in Response Rates|17.44||||0.0154|TWO_SIDED|95.0|1.96|32.93|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||32.93|1.96|0.0154
74090022|NCT04285567|147733072|SUPERIORITY||Difference in Rates|18.93||||0.0054|TWO_SIDED|95.0|0.91|36.95|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||36.95|0.91|0.0054
73992490|NCT03784820|147531447|SUPERIORITY||LS mean difference|-0.12||||0.98|TWO_SIDED|95.0|-8.18|7.95||Demand/Withdraw score: Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||7.95|-8.18|0.98
73992491|NCT03784820|147531447|SUPERIORITY||LS mean difference|-2.2||||0.59|TWO_SIDED|95.0|-10.1|5.7||Demand/Withdraw score: Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||5.70|-10.10|0.59
73992492|NCT03784820|147531447|SUPERIORITY||LS mean difference|2.41||||0.16|TWO_SIDED|95.0|-0.99|5.82||Constructive Communication Score: Comparison of Partners at Post (T2)|Mixed Models Analysis|||||5.82|-0.99|0.16
73992493|NCT03784820|147531447|SUPERIORITY||LS mean difference|3.94||||0.12|TWO_SIDED|95.0|-1.05|8.93||Constructive Communication Score: Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||8.93|-1.05|0.12
73992494|NCT03784820|147531447|SUPERIORITY||LS mean difference|2.26||||0.34|TWO_SIDED|95.0|-2.35|6.87||Constructive Communication Score: Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||6.87|-2.35|0.34
73992495|NCT03784820|147531448|SUPERIORITY||LS mean difference|0.09||||0.7|TWO_SIDED|95.0|-0.35|0.53||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||0.53|-0.35|0.70
73992496|NCT03784820|147531448|SUPERIORITY||LS mean difference|-0.03||||0.9|TWO_SIDED|95.0|-0.48|0.42||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||0.42|-0.48|0.90
73992497|NCT03784820|147531448|SUPERIORITY||LS mean difference|0.25||||0.38|TWO_SIDED|95.0|-0.31|0.82||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||0.82|-0.31|0.38
73992498|NCT03784820|147531449|SUPERIORITY||LS mean difference|-0.33||||0.89|TWO_SIDED|95.0|-5.1|4.43||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||4.43|-5.10|0.89
73992499|NCT03784820|147531449|SUPERIORITY||LS mean difference|0.45||||0.85|TWO_SIDED|95.0|-4.14|5.04||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||5.04|-4.14|0.85
73992500|NCT03784820|147531449|SUPERIORITY||LS mean difference|-0.85||||0.72|TWO_SIDED|95.0|-5.54|3.85||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||3.85|-5.54|0.72
73992501|NCT03784820|147531449|SUPERIORITY||LS mean difference|-3.05||||0.29|TWO_SIDED|95.0|-8.73|2.63||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.63|-8.73|0.29
73992502|NCT03784820|147531449|SUPERIORITY||LS mean difference|-4.69||||0.08|TWO_SIDED|95.0|-9.9|0.51||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||0.51|-9.90|0.08
74090023|NCT04285567|147733073|SUPERIORITY||Difference in Rates|26.79||||0.0038|TWO_SIDED|95.0|3.86|49.72|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||49.72|3.86|0.0038
73992503|NCT03784820|147531449|SUPERIORITY||LS mean difference|-3.29||||0.19|TWO_SIDED|95.0|-8.23|1.65||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||1.65|-8.23|0.19
74090024|NCT04285567|147733075|SUPERIORITY||Difference in Response Rates|3.05||||0.4199|TWO_SIDED|95.0|-5.73|11.84|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||11.84|-5.73|0.4199
74090025|NCT02011113|147733101|SUPERIORITY_OR_OTHER|||||||0.0027||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis(H0: p = 0.1)|Binomial test for dichotomized response|||||||0.0027
74090026|NCT03375320|147733142|SUPERIORITY||||||<|0.0001|||||||One-sided unstratified log-rank|||||||<0.0001
74090027|NCT03375320|147733142|SUPERIORITY||||||<|0.0001|||||||One-sided unstratified log-rank|||||||<0.0001
73992504|NCT03784820|147531450|SUPERIORITY||LS mean difference|-1.2||||0.41|TWO_SIDED|95.0|-4.08|1.67||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||1.67|-4.08|0.41
73992505|NCT03784820|147531450|SUPERIORITY||LS mean difference|0.33||||0.84|TWO_SIDED|95.0|-2.87|3.54||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||3.54|-2.87|0.84
73992506|NCT03784820|147531450|SUPERIORITY||LS mean difference|-1.21||||0.5|TWO_SIDED|95.0|-4.76|2.34||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||2.34|-4.76|0.50
73992507|NCT03784820|147531450|SUPERIORITY||LS mean difference|-1.09||||0.52|TWO_SIDED|95.0|-4.43|2.24||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.24|-4.43|0.52
73992508|NCT03784820|147531450|SUPERIORITY||LS mean difference|-1.38||||0.3|TWO_SIDED|95.0|-3.96|1.21||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||1.21|-3.96|0.30
73992509|NCT03784820|147531450|SUPERIORITY||LS mean difference|-2.52||||0.03|TWO_SIDED|95.0|-4.78|-0.25||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||-0.25|-4.78|0.03
73992510|NCT03784820|147531451|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.79|TWO_SIDED|95.0|-3.66|4.72||Comparison of Patients at Post (T2)|t-test, 2 sided|||||4.72|-3.66|0.79
73992511|NCT04147858|147531455|SUPERIORITY|||||||0.539|||||||t-test, 2 sided|||||||0.539
73992512|NCT04147858|147531455|SUPERIORITY|||||||0.425|||||||t-test, 2 sided|||||||0.425
73992513|NCT04147858|147531456|SUPERIORITY|||||||0.824|||||||t-test, 2 sided|||||||0.824
73992514|NCT04147858|147531456|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
73992515|NCT04147858|147531457|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
73992516|NCT04147858|147531457|SUPERIORITY|||||||0.603|||||||t-test, 2 sided|||||||0.603
73992517|NCT04147858|147531458|SUPERIORITY|||||||0.871|||||||t-test, 2 sided|||||||0.871
73992518|NCT04147858|147531458|SUPERIORITY|||||||0.352|||||||t-test, 2 sided|||||||0.352
73992519|NCT04147858|147531459|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
73992520|NCT04147858|147531459|SUPERIORITY|||||||0.626|||||||t-test, 2 sided|||||||0.626
73992521|NCT04147858|147531460|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||||||0.059
73992522|NCT04147858|147531460|SUPERIORITY|||||||0.726|||||||t-test, 2 sided|||||||0.726
73992523|NCT04147858|147531461|SUPERIORITY|||||||0.888|||||||t-test, 2 sided|||||||0.888
73992524|NCT04147858|147531461|SUPERIORITY|||||||0.832|||||||t-test, 2 sided|||||||0.832
73992525|NCT04147858|147531462|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||||||0.536
73992526|NCT04147858|147531462|SUPERIORITY|||||||0.982|||||||t-test, 2 sided|||||||0.982
73992527|NCT04147858|147531463|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.190
73992528|NCT04147858|147531463|SUPERIORITY|||||||0.764|||||||t-test, 2 sided|||||||0.764
73992529|NCT04147858|147531464|SUPERIORITY|||||||0.097|||||||t-test, 2 sided|||||||0.097
73992530|NCT04147858|147531464|SUPERIORITY|||||||0.849|||||||t-test, 2 sided|||||||0.849
73992531|NCT00658606|147531466|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.032
73992532|NCT00658606|147531467|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||No adjustments were made to multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.037
73992533|NCT00658606|147531468|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to 'Change from Baseline'||||0.001
73992534|NCT00658606|147531469|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'||||0.382
73992535|NCT00658606|147531470|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'||||0.052
73992536|NCT00658606|147531471|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'||||0.026
73992537|NCT00658606|147531472|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'PASI 90 = Yes'||||0.147
73992538|NCT00658606|147531473|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.566
73992539|NCT00658606|147531474|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.001
73992540|NCT00658606|147531475|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.007
73992541|NCT00658606|147531476|SUPERIORITY_OR_OTHER|||||||0.539||95.0||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'||||0.539
73992542|NCT03771638|147531477|SUPERIORITY|Minimum detectable effects: Under assumptions of the adherence of DBS TFV-DP levels \>=700 fmol/punch in the control condition as 60% and intraclass correlation of repeated binary measures of DBS TFV-DP of 0.69, and retention of 80% of participants at 24 weeks, we will have 80% power in 2-sided tests with a type-1 error rate of 5% to detect average between-group differences in adherence of 23 percentage points.|Risk Ratio (RR)|1.01||||0.94|TWO_SIDED|95.0|0.75|1.36||GEE poisson models with robust standard errors were used to assess DBS adherence rates, averaged across visits.|GEE Poisson models|||Null hypothesis: no difference in PrEP adherence levels between DOT Diary Intervention and Control arms||1.36|0.75|0.94
73992543|NCT03771638|147531478|OTHER||Kappa statistic|0.49|||||TWO_SIDED|95.0|0.36|0.62|||Kappa|||Kappa statistic to assess concordance between DBS measurement and self-reported PrEP use||0.62|0.36|
73992544|NCT06314438|147531483|EQUIVALENCE|paired samples t test with significance set at 0.05 p value||||||0.34|||||||t-test, 2 sided|||||||0.34
73992545|NCT06314438|147531484|EQUIVALENCE|paired samples t test with significance level at 0.05||||||0.05|||||||t-test, 2 sided|||||||0.05
73992546|NCT06314438|147531485|EQUIVALENCE|paired samples t test with significance set at 0.05 p value|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
74090028|NCT03375320|147733143|SUPERIORITY|||||||0.2438|||||||One-sided stratified log-rank|||||||0.2438
74090029|NCT03375320|147733143|SUPERIORITY|||||||0.4426|||||||One-sided stratified log-rank|||||||0.4426
74090030|NCT03375320|147733145|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
74090031|NCT03375320|147733145|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
73992547|NCT03170518|147531493|SUPERIORITY|Imputed datasets were analyzed using analysis of covariance (ANCOVA) with terms for treatment, stratification factors (antihyperglycemic agent background and age group), and baseline HbA1c.|Least square mean difference|-0.76|||=|0.002|TWO_SIDED|95.0|-1.25|-0.27|||ANCOVA|||||-0.27|-1.25|= 0.002
73876485|NCT02365649|147294828|SUPERIORITY||LS Mean Difference|-103.9||||0.788|TWO_SIDED|95.0|-865.69|657.87||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||657.87|-865.69|0.788
73876486|NCT02365649|147294828|SUPERIORITY||LS Mean Difference|-364.3||||0.325|TWO_SIDED|95.0|-1092.83|364.29||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||364.29|-1092.83|0.325
73876487|NCT02365649|147294828|SUPERIORITY||LS Mean Difference|-926.2||||0.015|TWO_SIDED|95.0|-1672.78|-179.63||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-179.63|-1672.78|0.015
73876488|NCT02365649|147294828|SUPERIORITY||LS Mean Difference|-763.1||||0.053|TWO_SIDED|95.0|-1534.52|8.39||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||8.39|-1534.52|0.053
73876489|NCT02365649|147294828|SUPERIORITY||LS Mean Difference|-359.5||||0.352|TWO_SIDED|95.0|-1119.52|400.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||400.56|-1119.52|0.352
73876490|NCT02365649|147294828|SUPERIORITY||LS Mean Difference|-396.2||||0.503|TWO_SIDED|95.0|-1565.39|772.9||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||772.90|-1565.39|0.503
73876491|NCT02365649|147294828|SUPERIORITY||LS Mean Difference|-364.3||||0.537|TWO_SIDED|95.0|-1531.04|802.44||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||802.44|-1531.04|0.537
73876492|NCT02365649|147294828|SUPERIORITY||LS Mean Difference|-483.2||||0.425|TWO_SIDED|95.0|-1677.87|711.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||711.52|-1677.87|0.425
73876493|NCT02365649|147294828|SUPERIORITY||LS Mean Difference|-1025.6||||0.134|TWO_SIDED|95.0|-2373.24|322.08||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||322.08|-2373.24|0.134
73992548|NCT03023423|147531548|SUPERIORITY||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.03|1.92||||||||1.92|0.03|
73992549|NCT03512197|147531558|SUPERIORITY||Hazard Ratio (HR)|1.0239|||||TWO_SIDED|95.0|0.8|1.31||||||||1.31|0.8|
73876494|NCT02365649|147294828|SUPERIORITY||LS Mean Difference|-637.9||||0.293|TWO_SIDED|95.0|-1833.82|557.96||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||557.96|-1833.82|0.293
73992550|NCT03512197|147531559|SUPERIORITY||Hazard Ratio (HR)|0.8728|||||TWO_SIDED|95.0|0.59|1.29||||||||1.29|0.59|
73992551|NCT03512197|147531564|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.6|1.63||||||||1.63|0.60|
73992552|NCT03512197|147531565|SUPERIORITY||Hazard Ratio (HR)|1.5866|||||TWO_SIDED|95.0|0.88|2.87||||||||2.87|0.88|
73992553|NCT03512197|147531566|SUPERIORITY||Hazard Ratio (HR)|0.7937|||||TWO_SIDED|95.0|0.41|1.54||||||||1.54|0.41|
73992554|NCT03512197|147531568|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.75|1.16||||||partial neutrophil recovery||1.16|0.75|
73992555|NCT03512197|147531568|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.72|1.14||||||full neutrophil recovery||1.14|0.72|
73992556|NCT03512197|147531569|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||partial platelet recovery||1.52|0.87|
73992557|NCT03512197|147531569|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.67|1.0||||||full platelet recovery||1.00|0.67|
73992558|NCT01227616|147531594|NON_INFERIORITY|The study protocol defined the margin for non-inferiority as 0.5 g/dL meaning non-inferiority would be established in a TP if the lower limit of the 95% confidence limit for the difference between ferumoxytol and iron sucrose mean change was ≥0.5 g/dL.|Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED||||||ANCOVA|Stats. of primary endpoint performed only for TP1 and TP2. 240 subjects retreated should yield 90% power to detect non-inferiority during TP2.||||||<0.05
73992559|NCT03358238|147531597|OTHER||Proportion|0.404|||||TWO_SIDED|95.0|0.264|0.557|||||Type of confidence interval = Clopper-Pearson|||0.557|0.264|
73992560|NCT03358238|147531598|SUPERIORITY||Difference in Average Proportions|0.0017||||0.99|TWO_SIDED|95.0|-0.1774|0.1807||Statistical significance was an alpha level of 0.05.|t-test, 2 sided|Two-sample t test. Degrees of freedom = 45.|Two-sample t confidence intervals|Null hypothesis was that the difference in average adherence rates of self-reporting between arms was zero.||0.1807|-0.1774|0.99
73992561|NCT03358238|147531599|SUPERIORITY||Risk Difference (RD)|-0.0189||||0.85|TWO_SIDED|95.0|-0.2215|0.1837||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|Two-sample t-test. Degrees of freedom = 45|Two-sample t confidence intervals|Null hypothesis was that the difference in average adherence rates to activity tracking between arms was zero.||0.1837|-0.2215|0.85
73992562|NCT03358238|147531600|OTHER||Proportion|0.5385|||||TWO_SIDED|95.0|0.3718|0.6991|||||Type of confidence interval = Clopper-Pearson|Estimating proportion of individuals with higher adherence rates for self-report over activity tracking among individuals with unequal adherence rates||0.6991|0.3718|
73992563|NCT03358238|147531600|SUPERIORITY|||||||0.0828|||||||Chi-squared|Degrees of freedom = 1||Null hypothesis is that among individuals with unequal adherence rates, the proportion of individuals with greater adherence to self-report over activity tracking in the Review Arm is equal to the proportion of individuals with greater adherence to self-report over activity tracking in the No Review Arm.||||0.0828
73876495|NCT02365649|147294829|SUPERIORITY||LS Mean Difference|0.5||||0.921|TWO_SIDED|95.0|-9.02|9.97||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||9.97|-9.02|0.921
73876496|NCT02365649|147294829|SUPERIORITY||LS Mean Difference|-1.6||||0.75|TWO_SIDED|95.0|-11.19|8.08||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||8.08|-11.19|0.75
73876497|NCT02365649|147294829|SUPERIORITY||LS Mean Difference|-1.9||||0.7|TWO_SIDED|95.0|-11.7|7.87||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||7.87|-11.7|0.7
73876498|NCT02365649|147294829|SUPERIORITY||LS Mean Difference|-11.4||||0.024|TWO_SIDED|95.0|-21.38|-1.51||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-1.51|-21.38|0.024
73876499|NCT02365649|147294829|SUPERIORITY||LS Mean Difference|-1.0||||0.845|TWO_SIDED|95.0|-10.72|8.79||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||8.79|-10.72|0.845
73992564|NCT03358238|147531601|OTHER||Mean Difference (Net)|0.79||||0.2|TWO_SIDED|95.0|-0.42|1.99||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|One-sample t-test. Degrees of freedom = 46.|"One participant had a single item missing on the Young Mania Rating Scale administered at study start. A zero was imputed for the missing item to recover a total score.~One-sample t confidence intervals."|"One participant had a single item missing on the Young Mania Rating Scale administered at study start. A zero was imputed for the missing item to recover a total score.~Null hypothesis was that the average change in total scores was zero."||1.99|-0.42|0.20
73992565|NCT03358238|147531602|OTHER||Mean Difference (Net)|0.89||||0.32|TWO_SIDED|95.0|-0.91|2.7||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|One-sample t test. Degrees of freedom = 46|One-sample t confidence intervals|Null hypothesis was that average change in scores on the structured interview guide for the Hamilton rating scale for depression is zero.||2.70|-0.91|0.32
73992566|NCT01431950|147531603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077||||||95.0|-0.039|0.192||||||||0.192|-0.039|
73992567|NCT04535544|147531869|SUPERIORITY||Difference of percentage|23.7||||0.011|TWO_SIDED|95.0|3.52|43.96|||Mantel-Haenszel|||Stratum-adjusted Mantel-Haenszel (MH) test was used to assess the difference of percentage based on stratification factor: HBeAg status at screening (positive vs negative).||43.96|3.52|0.011
73992568|NCT04535544|147531870|SUPERIORITY||Difference of percentage|26.8||||0.003|TWO_SIDED|95.0|7.38|46.21|||Mantel-Haenszel|||Stratum-adjusted MH test was used to assess the difference of percentage based on stratification factor: HBeAg status at screening (positive vs negative).||46.21|7.38|0.003
73992569|NCT01124838|147531889|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.004|TWO_SIDED|95.0|0.39|0.84|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.||0.84|0.39|0.004
73992570|NCT01124838|147531889|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.37|0.74|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.||0.74|0.37|<0.001
73992571|NCT01124838|147531890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.14||||0.218|TWO_SIDED|95.0|-0.37|0.08|||ANOVA|From ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.08|-0.37|0.218
73992572|NCT01124838|147531890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.15||||0.164|TWO_SIDED|95.0|-0.36|0.06|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.06|-0.36|0.164
73876500|NCT02365649|147294830|SUPERIORITY||LS Mean Difference|1.7||||0.83|TWO_SIDED|95.0|-13.6|16.92||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||16.92|-13.60|0.830
73876501|NCT02365649|147294830|SUPERIORITY||LS Mean Difference|17.5||||0.027|TWO_SIDED|95.0|2.03|33.0||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||33.00|2.03|0.027
73876502|NCT02365649|147294830|SUPERIORITY||LS Mean Difference|8.9||||0.263|TWO_SIDED|95.0|-6.72|24.47||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||24.47|-6.72|0.263
73876503|NCT02365649|147294830|SUPERIORITY||LS Mean Difference|21.6||||0.008|TWO_SIDED|95.0|5.68|37.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||37.52|5.68|0.008
73876504|NCT02365649|147294830|SUPERIORITY||LS Mean Difference|8.8||||0.269|TWO_SIDED|95.0|-6.88|24.53||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||24.53|-6.88|0.269
73876505|NCT02365649|147294830|SUPERIORITY||LS Mean Difference|10.3||||0.231|TWO_SIDED|95.0|-6.63|27.25||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||27.25|-6.63|0.231
73992573|NCT01124838|147531891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.13||||0.07|TWO_SIDED|95.0|-0.28|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.01|-0.28|0.070
73992574|NCT01124838|147531891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.17||||0.016|TWO_SIDED|95.0|-0.31|-0.03|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.03|-0.31|0.016
73992575|NCT01124838|147531892|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.04||||0.096|TWO_SIDED|95.0|-0.08|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.01|-0.08|0.096
73992576|NCT01124838|147531892|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.04||||0.044|TWO_SIDED|95.0|-0.09|0.0|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.00|-0.09|0.044
73992577|NCT01124838|147531893|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.491|TWO_SIDED|95.0|0.34|1.69|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.69|0.34|0.491
73992578|NCT01124838|147531893|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6||||0.185|TWO_SIDED|95.0|0.28|1.28|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.28|0.28|0.185
73992579|NCT01124838|147531894|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-2.3||||0.451|TWO_SIDED|95.0|-8.5|3.8|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||3.8|-8.5|0.451
73992580|NCT01124838|147531894|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-3.9||||0.174|TWO_SIDED|95.0|-9.7|1.8|||ANOVA|From ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.8|-9.7|0.174
73992581|NCT01124838|147531895|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|2.12||||0.16|TWO_SIDED|95.0|-0.84|5.08|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.08|-0.84|0.160
74035530|NCT04570657|147623934|SUPERIORITY||LS mean Difference|0.077||||0.186|TWO_SIDED|80.0|-0.034|0.187||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose A - Placebo|≥ 2 Exacerbation in Last 12 Months||0.187|-0.034|0.186
74009243|NCT01380730|147569259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.4|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-35.83|-26.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-26.97|-35.83|<0.001
74009244|NCT01380730|147569259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.65|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-39.99|-31.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-31.32|-39.99|<0.001
73876506|NCT02365649|147294830|SUPERIORITY||LS Mean Difference|27.9||||0.002|TWO_SIDED|95.0|10.68|45.15||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||45.15|10.68|0.002
73876507|NCT02365649|147294830|SUPERIORITY||LS Mean Difference|17.1||||0.057|TWO_SIDED|95.0|-0.51|34.72||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||34.72|-0.51|0.057
73876508|NCT02365649|147294830|SUPERIORITY||LS Mean Difference|28.8||||0.002|TWO_SIDED|95.0|11.12|46.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||46.56|11.12|0.002
73876509|NCT02365649|147294830|SUPERIORITY||LS Mean Difference|12.3||||0.165|TWO_SIDED|95.0|-5.12|29.72||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||29.72|-5.12|0.165
73992582|NCT01124838|147531895|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.77||||0.205|TWO_SIDED|95.0|-0.97|4.52|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.52|-0.97|0.205
73992583|NCT01124838|147531896|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.88||||0.401|TWO_SIDED|95.0|-2.53|6.29|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.29|-2.53|0.401
74035531|NCT04570657|147623934|SUPERIORITY||LS mean difference|0.212||||0.007|TWO_SIDED|80.0|0.102|0.322||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose B - Placebo|≥ 2 Exacerbation in Last 12 Months||0.322|0.102|0.007
73992584|NCT01124838|147531896|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|2.36||||0.256|TWO_SIDED|95.0|-1.73|6.45|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.45|-1.73|0.256
73992585|NCT01124838|147531897|SUPERIORITY_OR_OTHER_LEGACY||Mena Difference|-0.1||||0.967|TWO_SIDED|95.0|-4.81|4.61|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.61|-4.81|0.967
73992586|NCT01124838|147531897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.87||||0.714|TWO_SIDED|95.0|-5.53|3.79|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||3.79|-5.53|0.714
73876510|NCT02365649|147294831|SUPERIORITY||Adjusted risk difference from placebo|20.0||||0.167|TWO_SIDED|95.0|-8.4|48.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.4|-8.4|0.167
73876511|NCT02365649|147294831|SUPERIORITY||Adjusted risk difference from placebo|16.7||||0.221|TWO_SIDED|95.0|-10.0|43.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||43.3|-10.0|0.221
73992587|NCT01124838|147531898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|0.56||||0.83|TWO_SIDED|95.0|-4.56|5.68|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.68|-4.56|0.830
73992588|NCT01124838|147531898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.49||||0.842|TWO_SIDED|95.0|-5.32|4.34|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese vs. non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.34|-5.32|0.842
74035532|NCT04570657|147623935|SUPERIORITY||Geometric LS Mean Ratio|0.63|||<|0.001|TWO_SIDED|80.0|0.559|0.71||One-sided p-value|MMRM|||Analysis at Week 16 based on MMRM which included fixed effects for baseline, background medication, geographic region, baseline ICS total daily dose, visit, treatment and the baseline by visit and treatment by visit interactions.||0.710|0.559|< 0.001
73876512|NCT02365649|147294831|SUPERIORITY||Adjusted risk difference from placebo|20.0||||0.18|TWO_SIDED|95.0|-9.2|49.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.2|-9.2|0.18
73876513|NCT02365649|147294831|SUPERIORITY||LS Mean Difference|20.0||||0.167|TWO_SIDED|95.0|-8.4|48.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.4|-8.4|0.167
73876514|NCT02365649|147294832|SUPERIORITY||Adjusted risk difference from placebo|5.5||||0.607|TWO_SIDED|95.0|-15.5|26.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.5|-15.5|0.607
73992589|NCT04297618|147531899|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73992590|NCT04297618|147531900|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74035533|NCT04570657|147623935|SUPERIORITY||Geometric LS Mean Ratio|0.675|||<|0.001|TWO_SIDED|80.0|0.599|0.76||One-sided p-value|MMRM|||Analysis at Week 16 based on MMRM which included fixed effects for baseline, background medication, geographic region, baseline ICS total daily dose, visit, treatment and the baseline by visit and treatment by visit interactions.||0.760|0.599|< 0.001
74035534|NCT04047121|147623947|SUPERIORITY|||||||0.2531|||||||Chi-squared|||||||0.2531
74035535|NCT04047121|147623947|SUPERIORITY|||||||0.0295|||||||Chi-squared|||||||0.0295
74035536|NCT04047121|147623947|SUPERIORITY|||||||0.1857|||||||Chi-squared|||||||0.1857
74035537|NCT04047121|147623947|SUPERIORITY||Odds Ratio (OR)|0.8401||||0.3297|TWO_SIDED|95.0|0.5919|1.1925|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.1925|0.5919|0.3297
74035538|NCT04047121|147623947|SUPERIORITY||Odds Ratio (OR)|1.5066||||0.2003|TWO_SIDED|95.0|0.8046|2.8209|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.8209|0.8046|0.2003
74035539|NCT04047121|147623947|SUPERIORITY||Odds Ratio (OR)|1.4052||||0.2276|TWO_SIDED|95.0|0.8086|2.442|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.4420|0.8086|0.2276
74035540|NCT04047121|147623948|SUPERIORITY|||||||0.8786|||||||Chi-squared|||||||0.8786
74035541|NCT04047121|147623948|SUPERIORITY|||||||0.1178|||||||Chi-squared|||||||0.1178
73876515|NCT02365649|147294832|SUPERIORITY||Adjusted risk difference from placebo|12.2||||0.272|TWO_SIDED|95.0|-9.6|33.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.9|-9.6|0.272
73992591|NCT02726945|147531902|SUPERIORITY|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."||||0.023
73992592|NCT02726945|147531902|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."||||0.043
73992593|NCT02783573|147531981|SUPERIORITY||LS Mean Difference (Final Values)|2.51|STANDARD_ERROR_OF_MEAN|1.64||0.129|TWO_SIDED|95.0|-0.752|5.776|||Mixed Models Analysis|||||5.776|-0.752|0.129
73992594|NCT02783573|147531981|SUPERIORITY||LS Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.76||0.903|TWO_SIDED|95.0|-3.725|3.296|||Mixed Models Analysis|||||3.296|-3.725|0.903
73992595|NCT02783573|147531982|SUPERIORITY||LS Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|1.78||0.1|TWO_SIDED|95.0|-6.488|0.58|||Mixed Models Analysis|||||0.580|-6.488|0.100
73992596|NCT02783573|147531982|SUPERIORITY||LS Mean Difference (Final Values)|-3.18|STANDARD_ERROR_OF_MEAN|1.86||0.092|TWO_SIDED|95.0|-6.876|0.525|||Mixed Models Analysis|||||0.525|-6.876|0.092
73992597|NCT02783573|147531983|SUPERIORITY||LS Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.14||0.285|TWO_SIDED|95.0|-1.045|3.499|||Mixed Models Analysis|||||3.499|-1.045|0.285
73992598|NCT02783573|147531983|SUPERIORITY||LS Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|1.19||0.661|TWO_SIDED|95.0|-2.889|1.843|||Mixed Models Analysis|||||1.843|-2.889|0.661
74035542|NCT04047121|147623948|SUPERIORITY|||||||0.5337|||||||Chi-squared|||||||0.5337
74035543|NCT04047121|147623948|SUPERIORITY||Odds Ratio (OR)|1.0283||||0.9212|TWO_SIDED|95.0|0.5911|1.789|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7890|0.5911|0.9212
73992599|NCT02783573|147531984|SUPERIORITY||LS Mean Difference (Final Values)|-4.77|STANDARD_ERROR_OF_MEAN|2.69||0.079|TWO_SIDED|95.0|-10.103|0.56|||Mixed Models Analysis|||||0.56|-10.103|0.079
73992600|NCT02783573|147531984|SUPERIORITY||LS Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|2.82||0.486|TWO_SIDED|95.0|-7.573|3.62|||Mixed Models Analysis|||||3.62|-7.573|0.486
73992601|NCT02783573|147531985|SUPERIORITY||LS Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.57||0.663|TWO_SIDED|95.0|-0.89|1.391|||Mixed Models Analysis|||||1.391|-0.890|0.663
73992602|NCT02783573|147531985|SUPERIORITY||LS Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.6||0.717|TWO_SIDED|95.0|-1.423|0.983|||Mixed Models Analysis|||||0.983|-1.423|0.717
73992603|NCT02783573|147531987|SUPERIORITY||LS Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|2.34||0.899|TWO_SIDED|95.0|-4.297|4.889|||Mixed Models Analysis|||||4.889|-4.297|0.899
73992604|NCT02783573|147531987|SUPERIORITY||LS Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|2.16||0.164|TWO_SIDED|95.0|-7.267|1.238|||Mixed Models Analysis|||||1.238|-7.267|0.164
73992605|NCT02783573|147531988|SUPERIORITY||LS Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.82||0.126|TWO_SIDED|95.0|-2.891|0.362|||Mixed Models Analysis|||||0.362|-2.891|0.126
73876516|NCT02365649|147294832|SUPERIORITY||Adjusted risk difference from placebo|15.9||||-0.157|TWO_SIDED|95.0|-6.1|37.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.9|-6.1|-0.157
73876517|NCT02365649|147294832|SUPERIORITY||LS Mean Difference|27.7||||0.017|TWO_SIDED|95.0|4.9|50.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.6|4.9|0.017
73992606|NCT02783573|147531988|SUPERIORITY||LS Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.86||0.862|TWO_SIDED|95.0|-1.867|1.566|||Mixed Models Analysis|||||1.566|-1.867|0.862
73992607|NCT02783573|147531989|SUPERIORITY||LS Mean Difference (Final Values)|-37.55|STANDARD_ERROR_OF_MEAN|37.49||0.343|TWO_SIDED|95.0|-122.35|47.26|||ANCOVA|||||47.26|-122.35|0.343
73992608|NCT02783573|147531989|SUPERIORITY||LS Mean Difference (Final Values)|-40.72|STANDARD_ERROR_OF_MEAN|35.12||0.276|TWO_SIDED|95.0|-120.17|38.73|||ANCOVA|||||38.73|-120.17|0.276
73992609|NCT02783573|147531990|SUPERIORITY||LS Mean Difference (Final Values)|-61.94|STANDARD_ERROR_OF_MEAN|31.3||0.079|TWO_SIDED|95.0|-132.75|8.87|||ANCOVA|||||8.87|-132.75|0.079
73992610|NCT02783573|147531990|SUPERIORITY||LS Mean Difference (Final Values)|-34.15|STANDARD_ERROR_OF_MEAN|31.27||0.303|TWO_SIDED|95.0|-104.88|36.59|||ANCOVA|||||36.59|-104.88|0.303
73992611|NCT02783573|147531991|SUPERIORITY||LS Mean Difference (Final Values)|16.32|STANDARD_ERROR_OF_MEAN|14.29||0.283|TWO_SIDED|95.0|-16.015|48.659|||ANCOVA|||||48.659|-16.015|0.283
73992612|NCT02783573|147531991|SUPERIORITY||LS Mean Difference (Final Values)|-13.05|STANDARD_ERROR_OF_MEAN|13.21||0.349|TWO_SIDED|95.0|-42.929|16.82|||ANCOVA|||||16.820|-42.929|0.349
73992613|NCT02783573|147531992|SUPERIORITY||LS Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|2.23||0.494|TWO_SIDED|95.0|-3.457|6.64|||ANCOVA|||||6.640|-3.457|0.494
74035544|NCT04047121|147623948|SUPERIORITY||Odds Ratio (OR)|0.7464||||0.4693|TWO_SIDED|95.0|0.338|1.6482|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6482|0.3380|0.4693
74035545|NCT04047121|147623948|SUPERIORITY||Odds Ratio (OR)|0.8212||||0.5593|TWO_SIDED|95.0|0.4239|1.591|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5910|0.4239|0.5593
74035546|NCT04047121|147623949|SUPERIORITY|||||||0.6205|||||||Chi-squared|||||||0.6205
74035547|NCT04047121|147623949|SUPERIORITY|||||||0.4924|||||||Chi-squared|||||||0.4924
73876518|NCT02365649|147294832|SUPERIORITY||Adjusted risk difference from placebo|2.8||||0.798|TWO_SIDED|95.0|-18.4|23.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||23.9|-18.4|0.798
73876519|NCT02365649|147294833|SUPERIORITY||Adjusted risk difference from placebo|9.8||||0.119|TWO_SIDED|95.0|-2.5|22.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.1|-2.5|0.119
73876520|NCT02365649|147294833|SUPERIORITY||Adjusted risk difference from placebo|15.4||||0.034|TWO_SIDED|95.0|1.1|29.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.7|1.1|0.034
73876521|NCT02365649|147294833|SUPERIORITY||Adjusted risk difference from placebo|23.2||||0.004|TWO_SIDED|95.0|7.3|39.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||39.2|7.3|0.004
73876522|NCT02365649|147294833|SUPERIORITY||Adjusted risk difference from placebo|32.4|||<|0.001|TWO_SIDED|95.0|14.2|50.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.5|14.2|< 0.001
73876523|NCT02365649|147294833|SUPERIORITY||Adjusted risk difference from placebo|22.9|||<|0.006|TWO_SIDED|95.0|6.6|39.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||39.2|6.6|< 0.006
73876524|NCT02365649|147294834|SUPERIORITY||Adjusted risk difference from placebo|3.9||||0.647|TWO_SIDED|95.0|-12.7|20.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||20.5|-12.7|0.647
73876525|NCT02365649|147294834|SUPERIORITY||Adjusted risk difference from placebo|17.1||||0.093|TWO_SIDED|95.0|-2.9|37.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.1|-2.9|0.093
73876526|NCT02365649|147294834|SUPERIORITY||Adjusted risk difference from placebo|13.6||||0.165|TWO_SIDED|95.0|-5.6|32.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.8|-5.6|0.165
73876527|NCT02365649|147294834|SUPERIORITY||Adjusted risk difference from placebo|24.9||||0.023|TWO_SIDED|95.0|3.4|46.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||46.3|3.4|0.023
73876528|NCT02365649|147294834|SUPERIORITY||Adjusted risk difference from placebo|7.0||||0.448|TWO_SIDED|95.0|-11.0|25.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||25.0|-11.0|0.448
73876529|NCT02365649|147294835|SUPERIORITY||LS Mean Difference|0.4||||0.412|TWO_SIDED|95.0|-0.62|1.5||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||1.5|-0.62|0.412
73876530|NCT02365649|147294835|SUPERIORITY||LS Mean Difference|-1.4||||0.01|TWO_SIDED|95.0|-2.47|-0.34||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.34|-2.47|0.01
73876531|NCT02365649|147294835|SUPERIORITY||LS Mean Difference|-1.0||||0.082|TWO_SIDED|95.0|-2.13|0.13||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.13|-2.13|0.082
73876532|NCT02365649|147294835|SUPERIORITY||LS Mean Difference|-1.6||||0.004|TWO_SIDED|95.0|-2.73|-0.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.52|-2.73|0.004
73876533|NCT02365649|147294835|SUPERIORITY||LS Mean Difference|0.2||||0.766|TWO_SIDED|95.0|-0.93|1.26||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||1.26|-0.93|0.766
73876534|NCT02365649|147294836|SUPERIORITY||LS Mean Difference|-0.6||||0.314|TWO_SIDED|95.0|-1.75|0.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.56|-1.75|0.314
73992614|NCT02783573|147531992|SUPERIORITY||LS Mean Difference (Final Values)|-2.13|STANDARD_ERROR_OF_MEAN|2.04||0.323|TWO_SIDED|95.0|-6.743|2.481|||ANCOVA|||||2.481|-6.743|0.323
73876535|NCT02365649|147294836|SUPERIORITY||LS Mean Difference|-1.8||||0.002|TWO_SIDED|95.0|-3.01|-0.68||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.68|-3.01|0.002
73876536|NCT02365649|147294836|SUPERIORITY||LS Mean Difference|-0.7||||0.255|TWO_SIDED|95.0|-1.94|0.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.52|-1.94|0.255
73876537|NCT02365649|147294836|SUPERIORITY||LS Mean Difference|-1.4||||0.022|TWO_SIDED|95.0|-2.61|-0.2||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.2|-2.61|0.022
73876538|NCT02365649|147294836|SUPERIORITY||LS Mean Difference|-0.7||||0.239|TWO_SIDED|95.0|-1.92|0.48||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.48|-1.92|0.239
73876539|NCT02365649|147294837|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-36.4|21.4||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||21.4|-36.4|1.000
73992615|NCT02783573|147531993|SUPERIORITY||LS Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|13.76||0.873|TWO_SIDED|95.0|-26.569|31.017|||ANCOVA|||||31.017|-26.569|0.873
73992616|NCT02783573|147531993|SUPERIORITY||LS Mean Difference (Final Values)|-15.2|STANDARD_ERROR_OF_MEAN|15.43||0.337|TWO_SIDED|95.0|-47.488|17.096|||ANCOVA|||||17.096|-47.488|0.337
74035548|NCT04047121|147623949|SUPERIORITY|||||||0.4982|||||||Chi-squared|||||||0.4982
73992617|NCT02783573|147531994|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.927|TWO_SIDED|95.0|-0.015|0.017|||ANCOVA|||||0.017|-0.015|0.927
73992618|NCT02783573|147531994|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.93|TWO_SIDED|95.0|-0.015|0.017|||ANCOVA|||||0.017|-0.015|0.930
73992619|NCT02783573|147531995|SUPERIORITY||LS Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|1.06||0.127|TWO_SIDED|95.0|-3.708|0.464|||ANCOVA|||||0.464|-3.708|0.127
73992620|NCT02783573|147531995|SUPERIORITY||LS Mean Difference (Final Values)|-3.08|STANDARD_ERROR_OF_MEAN|1.06||0.004|TWO_SIDED|95.0|-5.172|-0.991|||ANCOVA|||||-0.991|-5.172|0.004
73992621|NCT00233480|147531998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|TWO_SIDED|95.0|||||paired t test|||||||0.025
73992622|NCT00581893|147532004|SUPERIORITY|||||||0.5|||||||McNemar|||||||0.50
73992623|NCT00159263|147532005|OTHER|Friedman ANOVA followed Dunn's pairwise comparisons||||||0.04|||||||ANOVA|||||||0.04
73992624|NCT00159263|147532006|OTHER|Friedman Anova||||||0.01|||||||ANOVA|||||||0.01
73992625|NCT00159263|147532007|OTHER|Friedman Anova||||||0.04|||||||ANOVA|||||||0.04
73992626|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.2|STANDARD_DEVIATION|3.4||||95.0|17.2|17.3||||||IOP 1 year (n=11602)||17.3|17.2|
73992627|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|2.9||||95.0|16.8|17.0||||||IOP 1 year (n=4450)||17.0|16.8|
73992628|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.3|STANDARD_DEVIATION|2.2||||95.0|17.1|17.5||||||IOP 1 year (n=357)||17.5|17.1|
73992629|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|3.2||||95.0|16.4|17.3||||||IOP 1 year (n=220)||17.3|16.4|
73992630|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.6|STANDARD_DEVIATION|4.1||||95.0|17.5|17.8||||||IOP 1 year (n=3277)||17.8|17.5|
73992631|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.0|STANDARD_DEVIATION|3.4||||95.0|17.0|17.1||||||IOP 2 years (n=8051)||17.1|17.0|
73992632|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.8|STANDARD_DEVIATION|2.9||||95.0|16.7|16.9||||||IOP 2 years (n=2808)||16.9|16.7|
73992633|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.2|STANDARD_DEVIATION|1.8||||95.0|17.0|17.5||||||IOP 2 years (n=175)||17.5|17.0|
73992634|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.6|STANDARD_DEVIATION|2.8||||95.0|15.9|17.2||||||IOP 2 years (n=83)||17.2|15.9|
73992635|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.1|STANDARD_DEVIATION|3.7||||95.0|16.9|17.2||||||IOP 2 years (n=2002)||17.2|16.9|
73992636|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.0|STANDARD_DEVIATION|3.4||||95.0|16.9|17.1||||||IOP 3 years (n=5469)||17.1|16.9|
73992637|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.8|STANDARD_DEVIATION|3.2||||95.0|16.7|17.0||||||IOP 3 years (n=1932)||17.0|16.7|
73992638|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.5|STANDARD_DEVIATION|2.5||||95.0|16.9|18.1||||||IOP 3 years (n=64)||18.1|16.9|
73992639|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.5|STANDARD_DEVIATION|2.8||||95.0|15.7|17.4||||||IOP 3 years (n=44)||17.4|15.7|
73992640|NCT01012245|147532008|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|3.6||||95.0|16.7|17.1||||||IOP 3 years (n=1251)||17.1|16.7|
73992641|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.46|STANDARD_DEVIATION|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 1 year (n=11966)||0.47|0.46|
73992642|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.44|STANDARD_DEVIATION|0.24||||95.0|0.43|0.44||||||Vertical C/D ratio 1 year (n=4944)||0.44|0.43|
73992643|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.39|STANDARD_DEVIATION|0.19||||95.0|0.35|0.43||||||Vertical C/D ratio 1 year (n=88)||0.43|0.35|
73992644|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.24||||95.0|0.47|0.53||||||Vertical C/D ratio 1 year (n=241)||0.53|0.47|
73992645|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.52||||||Vertical C/D ratio 1 year (n=2949)||0.52|0.50|
73992646|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.46|STANDARD_DEVIATION|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 2 years (n=8783)||0.47|0.46|
73992647|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.43|STANDARD_DEVIATION|0.23||||95.0|0.42|0.44||||||Vertical C/D ratio 2 years (n=3396)||0.44|0.42|
73992648|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.39|STANDARD_DEVIATION|0.16||||95.0|0.33|0.45||||||Vertical C/D ratio 2 years (n=31)||0.45|0.33|
73992649|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.24||||95.0|0.44|0.54||||||Vertical C/D ratio 2 years (n=95)||0.54|0.44|
73992650|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.53||||||Vertical C/D ratio 2 years (n=1934)||0.53|0.50|
73992651|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.24||||95.0|0.44|0.45||||||Vertical C/D ratio 3 years (n=6344)||0.45|0.44|
73992652|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.42|STANDARD_DEVIATION|0.22||||95.0|0.41|0.43||||||Vertical C/D ratio 3 years (n=2372)||0.43|0.41|
73992653|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.33|STANDARD_DEVIATION|0.14||||95.0|0.27|0.39||||||Vertical C/D ratio 3 years (n=25)||0.39|0.27|
73992654|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.47|STANDARD_DEVIATION|0.18||||95.0|0.41|0.53||||||Vertical C/D ratio 3 years (n=36)||0.53|0.41|
73992655|NCT01012245|147532010|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.26||||95.0|0.48|0.51||||||Vertical C/D ratio 3 years (n=1283)||0.51|0.48|
73992656|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.25||||95.0|0.45|0.46||||||Horizontal C/D ratio 1 year (n=11433)||0.46|0.45|
73992657|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.42|STANDARD_DEVIATION|0.23||||95.0|0.42|0.43||||||Horizontal C/D ratio 1 year (n=4810)||0.43|0.42|
73992658|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.37|STANDARD_DEVIATION|0.19||||95.0|0.33|0.42||||||Horizontal C/D ratio 1 year (n=87)||0.42|0.33|
73992659|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.25||||95.0|0.47|0.53||||||Horizontal C/D ratio 1 year (n=232)||0.53|0.47|
73992660|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.52||||||Horizontal C/D ratio 1 year (n=2703)||0.52|0.50|
73992661|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.25||||95.0|0.44|0.45||||||Horizontal C/D ratio 2 years (n=8427)||0.45|0.44|
73992662|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.41|STANDARD_DEVIATION|0.23||||95.0|0.4|0.42||||||Horizontal C/D ratio 2 years (n=3276)||0.42|0.40|
73992663|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.38|STANDARD_DEVIATION|0.19||||95.0|0.31|0.45||||||Horizontal C/D ratio 2 years (n=31)||0.45|0.31|
73992664|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.25||||95.0|0.45|0.56||||||Horizontal C/D ratio 2 years (n=92)||0.56|0.45|
73992665|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.49|0.52||||||Horizontal C/D ratio 2 years (n=1812)||0.52|0.49|
73992666|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.43|STANDARD_DEVIATION|0.24||||95.0|0.43|0.44||||||Horizontal C/D ratio 3 years (n=6102)||0.44|0.43|
73992667|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.4|STANDARD_DEVIATION|0.22||||95.0|0.39|0.41||||||Horizontal C/D ratio 3 years (n=2289)||0.41|0.39|
73992668|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.31|STANDARD_DEVIATION|0.15||||95.0|0.25|0.38||||||Horizontal C/D ratio 3 years (n=25)||0.38|0.25|
73992669|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.21||||95.0|0.42|0.57||||||Horizontal C/D ratio 3 years (n=35)||0.57|0.42|
73992670|NCT01012245|147532011|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.48|STANDARD_DEVIATION|0.26||||95.0|0.47|0.5||||||Horizontal C/D ratio 3 years (n=1204)||0.50|0.47|
73992671|NCT00132678|147532050|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.001||95.0|0.27|0.59|||Log Rank|Adjusting for country|RISPERDAL CONSTA hazard in numerator, placebo hazard in denominator.|||0.59|0.27|<0.001
73992672|NCT00132678|147532051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.09|<|0.001||95.0|-8.08|-3.79|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.|||-3.79|-8.08|<0.001
74035549|NCT04047121|147623949|SUPERIORITY||Odds Ratio (OR)|1.3182||||0.5494|TWO_SIDED|95.0|0.5335|3.257|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.2570|0.5335|0.5494
73992673|NCT00132678|147532052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.87||0.02||95.0|-3.75|-0.32|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.|||-0.32|-3.75|0.020
73992674|NCT01124097|147532086|SUPERIORITY_OR_OTHER|||||||0.9321|||||||Dunnett's test|||||||0.9321
73992675|NCT01124097|147532086|SUPERIORITY_OR_OTHER|||||||0.261|||||||Dunnett's test|||||||0.2610
73992676|NCT01124097|147532086|SUPERIORITY_OR_OTHER|||||||0.4764|||||||Dunnett's test|||||||0.4764
73992677|NCT01677299|147532088|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-22.5|||<|0.05|TWO_SIDED|95.0|-37.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment A.||||-8|-37|<0.05
73992678|NCT01677299|147532088|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-20.0|||<|0.05|TWO_SIDED|95.0|-30.0|-9.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment B.||||-9|-30|<0.05
73992679|NCT01677299|147532088|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-16.0|||<|0.05|TWO_SIDED|95.0|-24.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment C.||||-8|-24|<0.05
73992680|NCT01677299|147532088|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-21.0|||<|0.05|TWO_SIDED|95.0|-31.0|-11.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment D.||||-11|-31|<0.05
73992681|NCT01677299|147532089|SUPERIORITY_OR_OTHER||Geometric LS mean ration|1.6|||<|0.05|TWO_SIDED|95.0|1.4|1.9|||Mixed Models Analysis|||||1.9|1.4|<0.05
73992682|NCT01677299|147532089|SUPERIORITY_OR_OTHER||Geo LSmean ratio of (Day 5/Baseline)|1.9|||<|0.05|TWO_SIDED|95.0|1.5|2.3|||Mixed Models Analysis|||||2.3|1.5|<0.05
73992683|NCT01677299|147532089|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.7|||<|0.05|TWO_SIDED|95.0|1.4|2.0|||Mixed Models Analysis|||||2.0|1.4|<0.05
74035550|NCT04047121|147623949|SUPERIORITY||Odds Ratio (OR)|1.1664||||0.783|TWO_SIDED|95.0|0.39|3.4883|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.4883|0.3900|0.7830
73992684|NCT01677299|147532089|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.9|||<|0.05|TWO_SIDED|95.0|1.5|2.3|||Mixed Models Analysis|||||2.3|1.5|<0.05
73992685|NCT01677299|147532090|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.4|1.8|||Mixed Models Analysis|||||1.8|1.4|<0.05
73992686|NCT01677299|147532090|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.4|||<|0.05|TWO_SIDED|95.0|1.2|1.6|||Mixed Models Analysis|||||1.6|1.2|<0.05
73992687|NCT01677299|147532090|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.3|1.6|||Mixed Models Analysis|||||1.6|1.3|<0.05
73992688|NCT01677299|147532090|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.4|1.6|||Mixed Models Analysis|||||1.6|1.4|<0.05
73992689|NCT00150618|147532142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0|||||ANCOVA|||||||0.0041
73992690|NCT00150618|147532142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0176||95.0|||||ANCOVA|||||||0.0176
73992691|NCT00150618|147532142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||ANCOVA|||||||0.0016
73992692|NCT00150618|147532142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
73992693|NCT00150618|147532143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.0010
73992694|NCT00150618|147532143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0468||95.0|||||ANCOVA|||||||0.0468
73992695|NCT00150618|147532143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||ANCOVA|||||||0.0056
74035551|NCT04047121|147623950|SUPERIORITY|||||||0.3817|||||||Chi-squared|||||||0.3817
74035552|NCT04047121|147623950|SUPERIORITY|||||||0.7397|||||||Chi-squared|||||||0.7397
74035553|NCT04047121|147623950|SUPERIORITY|||||||0.7942|||||||Chi-squared|||||||0.7942
73876540|NCT02365649|147294837|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-22.5|32.5||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||32.5|-22.5|1.000
73876541|NCT02365649|147294837|SUPERIORITY||Risk Difference (RD)|-20.0||||0.272|TWO_SIDED|95.0|-37.5|-2.5||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||-2.5|-37.5|0.272
73876542|NCT02365649|147294837|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-2.7|8.6||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||8.6|-2.7|1.000
73992696|NCT00150618|147532143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0237||95.0|||||ANCOVA|||||||0.0237
73992697|NCT00150618|147532144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0074||95.0|||||Cochran-Mantel-Haenszel|||||||0.0074
73992698|NCT00150618|147532144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1404||95.0|||||Cochran-Mantel-Haenszel|||||||0.1404
73992699|NCT00150618|147532144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0055||95.0|||||Cochran-Mantel-Haenszel|||||||0.0055
74090032|NCT05611996|147733159|SUPERIORITY||Mean Difference (Net)|-1.783|STANDARD_ERROR_OF_MEAN|0.772||0.025|TWO_SIDED|95.0|-3.336|-0.23||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis||Score difference = Post-intervention - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention for all study participants.||-0.230|-3.336|0.025
73876543|NCT02365649|147294837|SUPERIORITY||Risk Difference (RD)|13.0||||0.068|TWO_SIDED|95.0|-0.7|26.8||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||26.8|-0.7|0.068
73876544|NCT02365649|147294837|SUPERIORITY||Risk Difference (RD)|-5.4||||1|TWO_SIDED|95.0|-23.1|12.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||12.3|-23.1|1.0000
73992700|NCT00150618|147532144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0|||||Cochran-Mantel-Haenszel|||||||0.0041
73992701|NCT00150618|147532145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0303||95.0|||||Cochran-Mantel-Haenszel|||||||0.0303
73992702|NCT00150618|147532145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4982||95.0|||||Cochran-Mantel-Haenszel|||||||0.4982
73992703|NCT00150618|147532145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|||||||0.0017
73992704|NCT00150618|147532145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Cochran-Mantel-Haenszel|||||||0.0063
73992705|NCT00150618|147532146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0383||95.0|||||ANCOVA|||Psychosocial category||||0.0383
73992706|NCT00150618|147532146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5859||95.0|||||ANCOVA|||Psychosocial category||||0.5859
73992707|NCT00150618|147532146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2136||95.0|||||ANCOVA|||Psychosocial category||||0.2136
73992708|NCT00150618|147532146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1483||95.0|||||ANCOVA|||Psychosocial category||||0.1483
74090033|NCT05611996|147733159|SUPERIORITY||Mean Difference (Net)|-2.42|STANDARD_ERROR_OF_MEAN|0.814||0.005|TWO_SIDED|95.0|-4.057|-0.784||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis||Score difference = 3-month - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 3-month for all study participants.||-0.784|-4.057|0.005
73992709|NCT00250432|147532155|NON_INFERIORITY_OR_EQUIVALENCE|Safety with caspofungin 150 mg daily will be non-inferior to that of caspofungin 70/50 mg. Non-inferiority was defined as upper limit of the 2-sided, 95% confidence interval for the difference (150-mg group - 70/50-mg group) must be less than 0.15 (15 percentage points).|Rate Difference|1.1|STANDARD_ERROR_OF_MEAN|5.6||||95.0|-4.1|6.8|||||The confidence interval computation was based on the method by Miettinen and Nurminen.|A significant drug-related adverse event was defined as either a drug-related serious adverse event or a drug-related adverse event leading to discontinuation of caspofungin therapy. Comparison between the 2 caspofungin groups was based on upper bound of the 95% confidence interval for the difference.||6.8|-4.1|
73992710|NCT00250432|147532156|SUPERIORITY_OR_OTHER||Rate Difference|6.3|STANDARD_ERROR_OF_MEAN|12.1||||95.0|-5.9|18.4|||||The 95% confidence interval on the difference will be based on the method of Miettinen and Nurminen.|There was no formal hypothesis testing for efficacy in this study. The main efficacy analysis was the number (percentage) of patients with a favorable overall response at the end of caspofungin study therapy, together with the within treatment 95% exact binomial confidence intervals, and the estimated treatment difference, and its 95% confidence interval.||18.4|-5.9|
73992711|NCT01210651|147532187|SUPERIORITY_OR_OTHER|||||||0.034||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with p-value \< 0.05 required a priori to reject the null hypothesis.|Regression, Generalized Least Squares|||A random-effects, generalized least squares (GLS) regression model for depression severity was used to analyze participant BDI scores measured just before 1st assigned session at 0 wks, and just after assigned sessions at 2 wks, 4 wks, 6 wks and 8 wks. BDI Scores were modeled as correlated within participants but independent between participants. The GLS regression model tested the null hypothesis that no significant effects on BDI scores would be found by intervention and intervention-by-time.||||0.034
73992712|NCT01210651|147532188|SUPERIORITY_OR_OTHER|||||||0.02||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on BDI, using two sample t-test to evaluate the null hypothesis that the Total Change Score on BDI for each intervention group would be statistically comparable.||||0.02
73992713|NCT01210651|147532189|SUPERIORITY_OR_OTHER|||||||0.018||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with a p-value \< 0.05 required a priori to reject the null hypothesis.|Fisher Exact|||Fisher's Exact test evaluated null hypothesis that the proportion of study completers with remitted depression would be statistically comparable in the 2 intervention groups.||||0.018
73992714|NCT01210651|147532190|SUPERIORITY_OR_OTHER|||||||0.5||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on GSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on GSES for each intervention group would be statistically comparable.||||0.50
73992715|NCT01210651|147532191|SUPERIORITY_OR_OTHER|||||||0.053||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on RSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on RSES for each intervention group would be statistically comparable.||||0.053
73992716|NCT02559310|147532197|NON_INFERIORITY|Non-inferiority Margin = 12.5%.|Treatment Difference (Lef - Mox)|-2.9|||||TWO_SIDED|95.0|-8.5|2.8|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic.|||2.8|-8.5|
73992717|NCT02559310|147532198|NON_INFERIORITY|Non-inferiority Margin = 10%.|Treatment Difference (Lef - Mox)|-2.6|||||TWO_SIDED|95.0|-8.9|3.9|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.9|-8.9|
73992718|NCT02559310|147532198|NON_INFERIORITY|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.6|||||TWO_SIDED|95.0|-9.2|4.1|||||Difference in percentage of Success for IACR at test of cure visit. CI computed using continuity-corrected Z-statistic.|||4.1|-9.2|
73992719|NCT02559310|147532199|NON_INFERIORITY|Non-Inferiority Margin = 10%.|Treatment Difference|-2.5|||||TWO_SIDED|95.0|-8.4|3.4|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.4|-8.4|
73992720|NCT02559310|147532199|NON_INFERIORITY|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.5|||||TWO_SIDED|95.0|-8.7|3.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic|||3.7|-8.7|
73992721|NCT04855734|147532228|SUPERIORITY||Mean ratio|0.962||||0.835|TWO_SIDED|95.0|0.661|1.396||Threshold for significance was \<0.05.|Mixed Models Analysis|||||1.396|0.661|0.835
73992722|NCT04855734|147532229|SUPERIORITY||Mean ratio|0.826||||0.032|TWO_SIDED|95.0|0.75|0.986||\<0.05 was threshold for significance level.|Mixed Models Analysis|||Meaning/Peace subscale which was a primary outcome.||0.986|0.75|0.032
73992723|NCT04855734|147532235|SUPERIORITY||Mean ratio|1.052||||0.284|TWO_SIDED|95.0|0.959|1.157||\<0.05 threshold for significance level.|Mixed Models Analysis|||Caregiver strain subscale scores at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||1.157|0.959|0.284
73992724|NCT04855734|147532235|SUPERIORITY||Mean ratioj|0.931||||0.228|TWO_SIDED|95.0|0.827|1.048||\<0.05 threshold for significance level.|Mixed Models Analysis|||Caregiver distress subscale controlling for baseline levels.||1.048|0.827|0.228
73992725|NCT04855734|147532235|SUPERIORITY||Mean ratio|0.984||||0.504|TWO_SIDED|95.0|0.94|1.032||\<0.05 significance level.|Mixed Models Analysis|||Family well-being subscale controlling for baseline levels.||1.032|0.94|0.504
73992726|NCT04855734|147532235|SUPERIORITY||Mean ratio|0.995||||0.741|TWO_SIDED|95.0|0.967|1.024||\<0.05 significance level.|Mixed Models Analysis|||Positive Caregiving Appraisals subscale at 3 month follow up, controlling for baseline levels.||1.024|0.967|0.741
73992727|NCT05131477|147532248|SUPERIORITY||LS Mean Difference|-32.1|STANDARD_ERROR_OF_MEAN|6.01|<|0.0001|TWO_SIDED|95.0|-43.9|-20.3|||ANCOVA||LS Mean Difference|||-20.3|-43.9|<0.0001
73992728|NCT05131477|147532248|SUPERIORITY||LS Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|5.98|<|0.0001|TWO_SIDED|95.0|-39.1|-15.6|||ANCOVA||LS Mean Difference|||-15.6|-39.1|<0.0001
73992729|NCT05131477|147532248|SUPERIORITY||LS Mean Difference|-22.2|STANDARD_ERROR_OF_MEAN|6.01||0.0002|TWO_SIDED|95.0|-34.0|-10.4|||ANCOVA||LS Mean Difference|||-10.4|-34.0|0.0002
73992730|NCT05131477|147532248|SUPERIORITY||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|5.95|<|0.0001|TWO_SIDED|95.0|-41.9|-18.5|||ANCOVA|||||-18.5|-41.9|<0.0001
73992731|NCT05131477|147532249|SUPERIORITY||LS Mean Difference|-36.8|STANDARD_ERROR_OF_MEAN|6.62|<|0.0001|TWO_SIDED|95.0|-49.8|-23.8|||ANCOVA||LS Mean Difference|||-23.8|-49.8|<0.0001
73992732|NCT05131477|147532249|SUPERIORITY||LS Mean Difference|-24.6|STANDARD_ERROR_OF_MEAN|6.67||0.0002|TWO_SIDED|95.0|-37.7|-11.6|||ANCOVA||LS Mean Difference|||-11.6|-37.7|0.0002
74090034|NCT05611996|147733159|SUPERIORITY||Mean Difference (Net)|-0.5468|STANDARD_ERROR_OF_MEAN|0.1744||0.004|TWO_SIDED|95.0|-0.9039|-0.1897||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis||The mean difference of the PHQ-9 score by each unit increase of the time(each week increase)|Null hypothesis: There is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores over time for all study participants.||-0.1897|-0.9039|0.0040
73992733|NCT05131477|147532249|SUPERIORITY||LS Mean Difference|-26.2|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|-39.2|-13.1|||ANCOVA||LS Mean Difference|||-13.1|-39.2|<0.0001
73992734|NCT05131477|147532249|SUPERIORITY||LS Mean Difference|-26.8|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|-39.7|-13.9|||ANCOVA||LS Mean Difference|||-13.9|-39.7|<0.0001
73992735|NCT05131477|147532250|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.42|||Cochran-Mantel-Haenszel|||Week 16||0.42|0.16|< 0.0001
73992736|NCT05131477|147532250|SUPERIORITY||Proportion Difference|0.27|||<|0.0001|TWO_SIDED|95.0|0.14|0.4|||Cochran-Mantel-Haenszel|||Week 16||0.40|0.14|< 0.0001
73992737|NCT05131477|147532250|SUPERIORITY||Proportion Difference|0.31|||<|0.0001|TWO_SIDED|95.0|0.18|0.44|||Cochran-Mantel-Haenszel|||Week 16||0.44|0.18|<0.0001
73992738|NCT05131477|147532250|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.42|||Cochran-Mantel-Haenszel|||Week 16||0.42|0.16|<0.0001
73876545|NCT02365649|147294837|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-15.7|18.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||18.3|-15.7|1.000
73992739|NCT05131477|147532250|SUPERIORITY||Proportion Difference|0.36|||<|0.0001|TWO_SIDED|95.0|0.23|0.5|||Cochran-Mantel-Haenszel|||Week 24||0.5|0.23|<0.0001
73992740|NCT05131477|147532250|SUPERIORITY||Proportion Difference|0.21||||0.004|TWO_SIDED|95.0|0.07|0.34|||Cochran-Mantel-Haenszel|||Week 24||0.34|0.07|0.0040
73992741|NCT05131477|147532250|SUPERIORITY||Proportion Difference|0.31|||<|0.0001|TWO_SIDED|95.0|0.17|0.45|||Cochran-Mantel-Haenszel|||||0.45|0.17|<0.0001
73992742|NCT05131477|147532250|SUPERIORITY||Proportion Difference|0.23||||0.0016|TWO_SIDED|95.0|0.09|0.36|||Cochran-Mantel-Haenszel|||||0.36|0.09|0.0016
73992743|NCT05131477|147532251|SUPERIORITY||Proportion Difference|0.17||||0.0022|TWO_SIDED|95.0|0.06|0.27|||Cochran-Mantel-Haenszel|||Week 16||0.27|0.06|0.0022
73992744|NCT05131477|147532251|SUPERIORITY||Proportion Difference|0.09||||0.0562|TWO_SIDED|95.0|0.0|0.18|||Cochran-Mantel-Haenszel|||Week 16||0.18|0|0.0562
73992745|NCT05131477|147532251|SUPERIORITY||Proportion Difference|0.14||||0.0054|TWO_SIDED|95.0|0.04|0.24|||Cochran-Mantel-Haenszel|||Week 16||0.24|0.04|0.0054
73992746|NCT05131477|147532251|SUPERIORITY||Proportion Difference|0.2||||0.0003|TWO_SIDED|95.0|0.1|0.31|||Cochran-Mantel-Haenszel|||Week 16||0.31|0.1|0.0003
73992747|NCT05131477|147532251|SUPERIORITY||Proportion Difference|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||Cochran-Mantel-Haenszel|||Week 24||0.47|0.21|<0.0001
73992748|NCT05131477|147532251|SUPERIORITY||Proportion Difference|0.22||||0.0008|TWO_SIDED|95.0|0.1|0.34|||Cochran-Mantel-Haenszel|||Week 24||0.34|0.1|0.0008
74090035|NCT04572243|147733172|SUPERIORITY||Median Difference (Final Values)|-86.08|||||TWO_SIDED|95.0|-144.01|-28.14||||||||-28.14|-144.01|
74090036|NCT04572243|147733173|SUPERIORITY||Odds Ratio (OR)|6.0|||||TWO_SIDED|95.0|0.81|44.35||||||||44.35|0.81|
73876546|NCT02365649|147294837|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-16.7|23.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||23.3|-16.7|1.000
73992749|NCT05131477|147532251|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.41|||Cochran-Mantel-Haenszel|||Week 24||0.41|0.16|<0.0001
73992750|NCT05131477|147532251|SUPERIORITY||Proportion Difference|0.18||||0.0046|TWO_SIDED|95.0|0.06|0.3|||Cochran-Mantel-Haenszel|||Week 24||0.3|0.06|0.0046
73992751|NCT05131477|147532252|SUPERIORITY||Proportion Difference|0.19||||0.0006|TWO_SIDED|95.0|0.09|0.3|||Cochran-Mantel-Haenszel|||Week 16||0.3|0.09|0.0006
73992752|NCT05131477|147532252|SUPERIORITY||Proportion Difference|0.14||||0.0057|TWO_SIDED|95.0|0.04|0.24|||Cochran-Mantel-Haenszel|||Week 16||0.24|0.04|0.0057
73992753|NCT05131477|147532252|SUPERIORITY||Proportion Difference|0.16||||0.0038|TWO_SIDED|95.0|0.05|0.26|||Cochran-Mantel-Haenszel|||Week 16||0.26|0.05|0.0038
73992754|NCT05131477|147532252|SUPERIORITY||Proportion Difference|0.18||||0.0011|TWO_SIDED|95.0|0.07|0.28|||Cochran-Mantel-Haenszel|||Week 16||0.28|0.07|0.0011
73992755|NCT05131477|147532252|SUPERIORITY||Proportion Difference|0.23||||0.0002|TWO_SIDED|95.0|0.11|0.35|||Cochran-Mantel-Haenszel|||Week 24||0.35|0.11|0.0002
73992756|NCT05131477|147532252|SUPERIORITY||Proportion Difference|0.17||||0.0038|TWO_SIDED|95.0|0.06|0.28|||Cochran-Mantel-Haenszel|||Week 24||0.28|0.06|0.0038
73992757|NCT05131477|147532252|SUPERIORITY||Proportion Difference|0.21||||0.0006|TWO_SIDED|95.0|0.09|0.32|||Cochran-Mantel-Haenszel|||Week 24||0.32|0.09|0.0006
73992758|NCT05131477|147532252|SUPERIORITY||Proportion Difference|20.0||||0.0008|TWO_SIDED|95.0|9.0|32.0|||Cochran-Mantel-Haenszel|||Week 24||32|9|0.0008
73992759|NCT05101993|147532304|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73992760|NCT01475305|147532349|SUPERIORITY_OR_OTHER||Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|||2.05|0.00|
73992761|NCT01475305|147532350|SUPERIORITY_OR_OTHER||Relative Risk|1.0|||||TWO_SIDED|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by quantitative real-time RT-PCR||6.24|0.16|
73992762|NCT01475305|147532350|SUPERIORITY_OR_OTHER||Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by DFA||2.05|0.00|
73992763|NCT01475305|147532350|SUPERIORITY_OR_OTHER||Relative Risk|1.0|||||TWO_SIDED|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by Any Method||6.24|0.16|
73992764|NCT00592293|147532373|OTHER||Cumulative incidence|17.0|||||TWO_SIDED|95.0|9.1|27.6||||||||27.6|9.1|
73992765|NCT00592293|147532374|OTHER||Percent Survival, Local Control|87.1|||||TWO_SIDED|95.0|78.1|93.7||||||||93.7|78.1|
73992766|NCT01606319|147532376|SUPERIORITY_OR_OTHER||relative rate|0.94||||0.67|TWO_SIDED|95.0|0.69|1.28|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator|||1.28|.69|0.67
73992767|NCT01606319|147532377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5|TWO_SIDED|95.0|-0.039|0.0019|||ANCOVA|||||.0019|-0.039|0.5
73992768|NCT01606319|147532378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.69|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||||0.6|-0.9|0.69
74090037|NCT03856593|147733204|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|95.0|-0.2|-0.07|||Mixed Models Analysis||This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly MME post-letter in the Outcome Measure Data table.|Please note that 10% of means in the pre-intervention period were trimmed to remove outliers.||-0.07|-0.20|<0.05
73876547|NCT02365649|147294837|SUPERIORITY||Risk Difference (RD)|4.8||||1|TWO_SIDED|95.0|-4.3|13.9||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders||13.9|-4.3|1.000
73876548|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-35.5|35.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||35.5|-35.5|1.000
73876549|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|12.5||||0.483|TWO_SIDED|95.0|-17.9|42.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||42.9|-17.9|0.483
73876550|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|-15.0||||0.633|TWO_SIDED|95.0|-41.6|11.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||11.6|-41.6|0.633
73992769|NCT01606319|147532379|SUPERIORITY_OR_OTHER||relative rate|0.99||||0.94|TWO_SIDED|95.0|0.72|1.37|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator|||1.37|0.72|.94
74090038|NCT03856593|147733205|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|95.0|-0.15|-0.02|||Mixed Models Analysis||This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly VME post-letter in the Outcome Measure Data table.|||-0.02|-0.15|<0.05
73876551|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|6.9||||0.424|TWO_SIDED|95.0|-12.7|26.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||26.4|-12.7|0.424
73876552|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|5.7||||0.614|TWO_SIDED|95.0|-5.6|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||17.0|-5.6|0.614
73876553|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|14.3||||0.149|TWO_SIDED|95.0|-2.4|30.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||30.9|-2.4|0.149
73876554|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|5.8||||0.684|TWO_SIDED|95.0|-19.1|30.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||30.7|-19.1|0.684
73876555|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|8.5||||0.404|TWO_SIDED|95.0|-11.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.5|-11.5|0.404
73876556|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|10.7||||0.47|TWO_SIDED|95.0|-12.8|34.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||34.1|-12.8|0.470
73876557|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
73876558|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|4.5||||1|TWO_SIDED|95.0|-11.3|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||20.3|-11.3|1.000
73992770|NCT00790205|147532431|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|TWO_SIDED|95.0|0.88|1.09|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.09|0.88|<0.001
74009245|NCT01380730|147569259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.97|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-40.29|-31.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-31.65|-40.29|<0.001
74090039|NCT01949116|147733206|NON_INFERIORITY|The P-value for the risk difference is from an asymptotic non-inferiority analysis for the proportion (risk) difference with a 15% non-inferiority margin.|Risk Difference (RD)|0.072||||0.0367|ONE_SIDED|90.0||0.134|||Farrington-Manning score (exact)||LDMTX - Placebo|||0.134||0.0367
73992771|NCT00790205|147532432|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|TWO_SIDED|95.0|0.89|1.08|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.08|0.89|<0.001
73992772|NCT00790205|147532433|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.11|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.11|0.89|<0.001
73992773|NCT00790205|147532434|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.1|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.10|0.89|<0.001
73992774|NCT00790205|147532435|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.06||||0.435|TWO_SIDED|95.0|0.91|1.24|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.24|0.91|0.435
73992775|NCT00790205|147532436|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.875|TWO_SIDED|95.0|0.9|1.14|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.14|0.90|0.875
73992776|NCT00790205|147532437|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.858|TWO_SIDED|95.0|0.81|1.19|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.19|0.81|0.858
73992777|NCT00790205|147532438|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.983|TWO_SIDED|95.0|0.83|1.2|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.20|0.83|0.983
73992778|NCT00790205|147532445|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.001|TWO_SIDED|95.0|0.61|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.77|0.61|<0.001
73992779|NCT00790205|147532446|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.79|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.79|0.63|<0.001
73992780|NCT00790205|147532447|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.65|0.75|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.75|0.65|<0.001
73992781|NCT00790205|147532448|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.68|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.77|0.68|<0.001
73992782|NCT01512797|147532451|OTHER|||||||0.028||||||P-value refers to paired t-test comparing pre-intervention and post-intervention timepoints in Sitagliptin group.|t-test, 2 sided|||Power analysis. Based on the effect of DPP-4 inhibitors in non-operated subjects with type 2 diabetes, showing a significant decrease in 120' post-prandial glucose by 1.67 mmol/L ± 0.98 mmol/L after a MMT, we estimated that a sample size of 16 subjects per group will show post-prandial glucose differences between placebo and sitagliptin group with α = 0.05 for a power \> 90%.||||0.028
73992783|NCT01080300|147532464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.311||0.0003|TWO_SIDED|95.0|-2.31|-1.09||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Eltereen|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 4."||-1.09|-2.31|0.0003
74090040|NCT01949116|147733207|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.55|TWO_SIDED|95.0|-0.67|0.85|||Wilcoxon (Mann-Whitney)|Stratified by Statin Use (study stratification factor)||||0.85|-0.67|0.55
74090041|NCT02858726|147733220|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.8|-2.8|<0.001
73992784|NCT01080300|147532464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.335||0.1|TWO_SIDED|95.0|-1.8|-0.48||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 12."||-0.48|-1.80|0.1000
74035554|NCT04047121|147623950|SUPERIORITY||Odds Ratio (OR)|1.0682||||0.7924|TWO_SIDED|95.0|0.6537|1.7455|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7455|0.6537|0.7924
74035555|NCT04047121|147623950|SUPERIORITY||Odds Ratio (OR)|1.0414||||0.9339|TWO_SIDED|95.0|0.3997|2.7134|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.7134|0.3997|0.9339
73992785|NCT01080300|147532465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.31|-0.1||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 4."||-0.10|-0.31|<0.0001
73992786|NCT01080300|147532465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.072||0.0004|TWO_SIDED|95.0|-0.33|-0.04||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 12."||-0.04|-0.33|0.0004
73992787|NCT01080300|147532466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.08|STANDARD_ERROR_OF_MEAN|0.453||0.151|TWO_SIDED|95.0|-1.98|-0.19|||Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily number of moderate to severe hot flashes at Week 24."||-0.19|-1.98|0.1510
73992788|NCT01080300|147532467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0004|TWO_SIDED|95.0|-0.44|0.0|||Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily severity score of moderate to severe hot flashes at Week 24."||-0.00|-0.44|0.0004
73992789|NCT01080300|147532468|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.6||||0.0008|TWO_SIDED|95.0|5.7|21.6|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the PGIC score at week 12.."||21.6|5.7|0.0008
73992790|NCT01080300|147532468|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.4||||0.0009|TWO_SIDED|95.0|5.5|21.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 24."||21.3|5.5|0.0009
73992791|NCT01080300|147532469|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.4|||<|0.0001|TWO_SIDED|95.0|8.4|24.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in CGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the CGIC score at week 12."||24.3|8.4|<0.0001
73992792|NCT01080300|147532469|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.0||||0.007|TWO_SIDED|95.0|3.0|19.0|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||19.0|3.0|0.0070
73992793|NCT01080300|147532470|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.5||||0.0609|TWO_SIDED|95.0|-0.3|15.2|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12||15.2|-0.3|0.0609
73992794|NCT01080300|147532470|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.3||||0.072|TWO_SIDED|95.0|-0.7|15.3|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||15.3|-0.7|0.0720
73992795|NCT01080300|147532471|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.8||||0.1825|TWO_SIDED|95.0|-1.8|9.4|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12||9.4|-1.8|0.1825
74035556|NCT04047121|147623950|SUPERIORITY||Odds Ratio (OR)|0.8195||||0.6497|TWO_SIDED|95.0|0.347|1.935|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.9350|0.3470|0.6497
74035557|NCT04047121|147623951|SUPERIORITY|||||||0.7936|||||||Chi-squared|||||||0.7936
74035558|NCT04047121|147623951|SUPERIORITY|||||||0.5621|||||||Chi-squared|||||||0.5621
74035559|NCT04047121|147623951|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.6800
74035560|NCT04047121|147623951|SUPERIORITY||Odds Ratio (OR)|1.1438||||0.5051|TWO_SIDED|95.0|0.7705|1.6978|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6978|0.7705|0.5051
74035561|NCT04047121|147623951|SUPERIORITY||Odds Ratio (OR)|0.8576||||0.7131|TWO_SIDED|95.0|0.3781|1.9452|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.9452|0.3781|0.7131
73992796|NCT01080300|147532471|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|4.4||||0.1662|TWO_SIDED|95.0|-1.8|10.7|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||10.7|-1.8|0.1662
74090042|NCT02858726|147733220|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.107|TWO_SIDED|95.0|-1.9|0.2|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||0.2|-1.9|0.107
74090043|NCT02858726|147733220|SUPERIORITY||Median Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.5||0.019|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.2|-2.3|0.019
73992797|NCT01080300|147532472|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.36|STANDARD_ERROR_OF_MEAN|0.196|<|0.0001|TWO_SIDED|95.0|-1.75|-0.97||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily sleep interference rating.||-0.97|-1.75|<0.0001
73992798|NCT01080300|147532472|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|0.226|<|0.0001|TWO_SIDED|95.0|-1.36|-0.47||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily sleep interference rating.||-0.47|-1.36|<0.0001
73992799|NCT01080300|147532472|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.237|<|0.0001|TWO_SIDED|95.0|-1.42|-0.49||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily sleep interference rating.||-0.49|-1.42|<0.0001
73992800|NCT01080300|147532473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.62|STANDARD_ERROR_OF_MEAN|0.537|<|0.0001|TWO_SIDED|95.0|-3.67|-1.56||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily insomnia severity index (ISI) rating.||-1.56|-3.67|<0.0001
74090044|NCT02858726|147733221|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-16.0|-4.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-4.8|-16.0|<0.001
73992801|NCT01080300|147532473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|0.543||0.0007|TWO_SIDED|95.0|-2.92|-0.78||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily insomnia severity index (ISI) rating.||-0.78|-2.92|0.0007
73992802|NCT01080300|147532473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.76|STANDARD_ERROR_OF_MEAN|0.548||0.0014|TWO_SIDED|95.0|-2.84|-0.69|||ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily insomnia severity index (ISI) rating.||-0.69|-2.84|0.0014
73992803|NCT01080300|147532474|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.084||0.0137|TWO_SIDED|95.0|-0.37|-0.04||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 4||-0.04|-0.37|0.0137
73992804|NCT01080300|147532474|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.084||0.0872|TWO_SIDED|95.0|-0.31|0.02||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 12||0.02|-0.31|0.0872
73992805|NCT01080300|147532474|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.091||0.5607|TWO_SIDED|95.0|-0.23|0.13||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 24||0.13|-0.23|0.5607
73992806|NCT00855413|147532528|OTHER|one sided ANOVA.|Mean Difference (Final Values)|4.23|STANDARD_DEVIATION|0.15||0.03|TWO_SIDED|||||The degrees of freedom (df) for the within factor (number of visits - 1) was 2, and the second df is the error df of 17.|ANOVA|||An overall summary score of neurocognitive functioning was created by averaging all tests. Best available demographically corrected normative data were utilized to create z scores and then deficit scores for impairment ratings.Change in neurocognitive functioning was analyzed using a one sided repeated measures ANOVA with neurocognitive performance as the dependent variable (total z score) and time (visit) as the independent variable. Degrees of freedom were 2,17.||||0.03
74009246|NCT01380730|147569259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.73|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-32.06|-23.39||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-23.39|-32.06|<0.001
74090045|NCT02858726|147733221|SUPERIORITY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|3.0||0.016|TWO_SIDED|95.0|-13.1|-1.4|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-1.4|-13.1|0.016
73992807|NCT00855413|147532530|OTHER|Spearman correlation|spearman correlation|-0.82|||<|0.005|TWO_SIDED|||||R = -0.82|Spearman correlation|||Correlation between time (days) to HIV RNA suppression \<200 copies/mL and total z score (mean) was assessed by Spearman correlation|Correlation between time (days) to HIV RNA suppression \<200 copies/mL and total z score (mean) was assessed by Spearman correlation|||<.005
73992808|NCT02493946|147532532|SUPERIORITY||Treatment difference|80.8|||<|0.0001|TWO_SIDED|95.0|73.7|88.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders.||88.0|73.7|<0.0001
73992809|NCT02493946|147532533|SUPERIORITY||Treatment difference|75.0|||<|0.0001|TWO_SIDED|95.0|67.1|82.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||82.8|67.1|<0.0001
73992810|NCT02493946|147532533|SUPERIORITY||Treatment difference|74.1|||<|0.0001|TWO_SIDED|95.0|66.2|82.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||82.1|66.2|<0.0001
73992811|NCT02493946|147532533|SUPERIORITY||Treatment difference|53.6|||<|0.0001|TWO_SIDED|95.0|44.2|63.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||63.1|44.2|<0.0001
73992812|NCT02493946|147532535|SUPERIORITY||Treatment difference|58.0|||<|0.0001|TWO_SIDED|95.0|44.5|71.6||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||71.6|44.5|<0.0001
73992813|NCT02493946|147532535|SUPERIORITY||Treatment difference|56.8|||<|0.0001|TWO_SIDED|95.0|44.5|69.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||69.0|44.5|<0.0001
73992814|NCT02493946|147532535|SUPERIORITY||Treatment difference|62.5|||<|0.0001|TWO_SIDED|95.0|52.1|72.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||72.9|52.1|<0.0001
73992815|NCT02493946|147532535|SUPERIORITY||Treatment difference|42.6|||<|0.0001|TWO_SIDED|95.0|29.5|55.7||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||55.7|29.5|<0.0001
73992816|NCT02493946|147532536|SUPERIORITY||Treatment difference|61.1|||<|0.0001|TWO_SIDED|95.0|51.9|70.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||70.3|51.9|<0.0001
73992817|NCT02493946|147532536|SUPERIORITY||Treatment difference|65.8|||<|0.0001|TWO_SIDED|95.0|56.8|74.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||74.8|56.8|<0.0001
73992818|NCT02493946|147532536|SUPERIORITY||Treatment difference|70.5|||<|0.0001|TWO_SIDED|95.0|62.2|78.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||78.8|62.2|<0.0001
73992819|NCT02493946|147532536|SUPERIORITY||Treatment difference|33.0|||<|0.0001|TWO_SIDED|95.0|24.0|42.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||42.0|24.0|<0.0001
74090046|NCT02858726|147733221|SUPERIORITY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.0||0.026|TWO_SIDED|95.0|-12.8|-0.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.8|-12.8|0.026
74090047|NCT02655016|147733222|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.502|0.755||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and homologous recombination deficiency (HRD) status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||0.755|0.502|<0.0001
73992820|NCT02493946|147532537|SUPERIORITY||Treatment difference|68.2|||<|0.0001|TWO_SIDED|95.0|58.2|78.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Linear|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||78.3|58.2|<0.0001
74009247|NCT01380730|147569260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.44|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-58.23|-48.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-48.65|-58.23|<0.001
73876559|NCT02365649|147294838|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
73876560|NCT02365649|147294839|SUPERIORITY||Risk Difference (RD)|-16.9||||0.624|TWO_SIDED|95.0|-48.4|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||14.6|-48.4|0.624
73876561|NCT02365649|147294839|SUPERIORITY||Risk Difference (RD)|3.9||||1|TWO_SIDED|95.0|-28.3|36.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||36.1|-28.3|1.000
73876562|NCT02365649|147294839|SUPERIORITY||Risk Difference (RD)|-19.4||||0.363|TWO_SIDED|95.0|-48.0|9.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||9.1|-48.0|0.363
73876563|NCT02365649|147294839|SUPERIORITY||Risk Difference (RD)|6.1||||0.495|TWO_SIDED|95.0|-2.1|14.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||14.2|-2.1|0.495
73876564|NCT02365649|147294839|SUPERIORITY||Risk Difference (RD)|15.0||||0.066|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||30.6|-0.6|0.066
73992821|NCT02493946|147532537|SUPERIORITY||Treatment difference|77.4|||<|0.0001|TWO_SIDED|95.0|68.6|86.2||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||86.2|68.6|<0.0001
73992822|NCT02493946|147532537|SUPERIORITY||Treatment difference|74.4|||<|0.0001|TWO_SIDED|95.0|65.7|83.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||83.1|65.7|<0.0001
73992823|NCT02493946|147532537|SUPERIORITY||Treatment difference|51.0|||<|0.0001|TWO_SIDED|95.0|42.0|59.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||59.9|42.0|<0.0001
74090048|NCT02655016|147733223|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1238|TWO_SIDED|95.0|0.442|1.106||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||1.106|0.442|0.1238
73876565|NCT02365649|147294839|SUPERIORITY||Risk Difference (RD)|-10.7||||0.645|TWO_SIDED|95.0|-30.3|8.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||8.9|-30.3|0.645
73992824|NCT02493946|147532538|SUPERIORITY||Hazard Ratio (HR)|15.296|||<|0.0001|TWO_SIDED||||||Cox proportional hazard model|The cox proportional hazard model used centre, gender and ILA baseline severity score as covariates.||Treatment difference in median time to onset of treatment response.||||<0.0001
73992825|NCT02493946|147532539|SUPERIORITY||Treatment difference|8.6|||<|0.0001|TWO_SIDED|95.0|5.2|12.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference ( BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||12.0|5.2|<0.0001
73992826|NCT02493946|147532539|SUPERIORITY||Treatment difference|11.1|||<|0.0001|TWO_SIDED|95.0|7.4|14.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||14.8|7.4|<0.0001
73992827|NCT02493946|147532539|SUPERIORITY||Treatment difference|10.4|||<|0.0001|TWO_SIDED|95.0|6.8|14.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||14.0|6.8|<0.0001
73992828|NCT02493946|147532539|SUPERIORITY||Treatment difference|9.6|||<|0.0001|TWO_SIDED|95.0|5.9|13.3||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||13.3|5.9|<0.0001
73992829|NCT02493946|147532540|SUPERIORITY||Treatment difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.0|13.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||13.6|5.0|<0.0001
74035562|NCT04047121|147623951|SUPERIORITY||Odds Ratio (OR)|0.8415||||0.649|TWO_SIDED|95.0|0.4003|1.769|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7690|0.4003|0.6490
74090049|NCT02655016|147733224|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0001|TWO_SIDED|95.0|0.521|0.802||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||0.802|0.521|0.0001
73992830|NCT02493946|147532540|SUPERIORITY||Treatment difference|11.4|||<|0.0001|TWO_SIDED|95.0|6.7|16.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||16.0|6.7|<0.0001
73992831|NCT02493946|147532540|SUPERIORITY||Treatment difference|11.2|||<|0.0001|TWO_SIDED|95.0|6.4|15.9||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||15.9|6.4|<0.0001
73992832|NCT02493946|147532540|SUPERIORITY||Treatment difference|8.1||||0.0004|TWO_SIDED|95.0|3.7|12.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||12.6|3.7|0.0004
73992833|NCT02493946|147532541|SUPERIORITY||Treatment difference|-0.6||||0.0174|TWO_SIDED|95.0|-1.1|-0.1||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||-0.1|-1.1|0.0174
73992834|NCT02493946|147532541|SUPERIORITY||Treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||-0.6|-1.7|<0.0001
73992835|NCT02493946|147532541|SUPERIORITY||Treatment difference|-1.4||||0.0001|TWO_SIDED|95.0|-2.0|-0.7||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||-0.7|-2.0|0.0001
73992836|NCT02493946|147532541|SUPERIORITY||Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.1|-0.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||-0.8|-2.1|<0.0001
73992837|NCT00848484|147532551|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.277
73992838|NCT00848484|147532552|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
74035563|NCT04047121|147623952|SUPERIORITY|||||||0.5217|||||||Chi-squared|||||||0.5217
73992839|NCT00848484|147532553|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.933
73992840|NCT00848484|147532554|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
73992841|NCT00848484|147532555|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|Wilcoxon (Mann-Whitney)|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
73992842|NCT00848484|147532556|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
73992843|NCT04069585|147532586|NON_INFERIORITY|To achieve non-inferiority, the observed p-value must be \<= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).|||||<|0.0002||||||One-sided paired t-test|t-test, 1 sided|||||||<0.0002
73992844|NCT00762476|147532595|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|95.0|||||Poisson regression|||||||>0.5000
74035564|NCT04047121|147623952|SUPERIORITY|||||||0.0432|||||||Chi-squared|||||||0.0432
74035565|NCT04047121|147623952|SUPERIORITY|||||||0.2573|||||||Chi-squared|||||||0.2573
74035566|NCT04047121|147623952|SUPERIORITY||Odds Ratio (OR)|1.1637||||0.5368|TWO_SIDED|95.0|0.7193|1.8827|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.8827|0.7193|0.5368
73992845|NCT00762476|147532596|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|95.0|||||Poisson regression|||||||>0.5000
73992846|NCT00762476|147532597|SUPERIORITY_OR_OTHER|||||||0.3451|TWO_SIDED|95.0|||||Poisson regression|||||||0.3451
73992847|NCT01637077|147532653|SUPERIORITY|||||||0.56|||||||Kruskal-Wallis|||||||0.56
73992848|NCT01637077|147532654|SUPERIORITY|||||||0.48|||||||Kruskal-Wallis|||||||0.48
73992849|NCT01637077|147532655|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||Worst pain over the past 24 hours||||0.62
73992850|NCT01637077|147532655|SUPERIORITY|||||||0.22|||||||Kruskal-Wallis|||Average pain over the past 24 hours||||0.22
73992851|NCT01637077|147532655|SUPERIORITY|||||||0.07|||||||Kruskal-Wallis|||Least pain over the past 24 hours||||0.07
73992852|NCT01637077|147532657|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
73992853|NCT01637077|147532658|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
73876566|NCT02365649|147294839|SUPERIORITY||Risk Difference (RD)|4.4||||0.686|TWO_SIDED|95.0|-16.8|25.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||25.5|-16.8|0.686
73992854|NCT01637077|147532659|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
73992855|NCT01637077|147532660|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||||||0.12
73992856|NCT01637077|147532661|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||0.78
73992857|NCT01637077|147532662|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
73992858|NCT01637077|147532663|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||Sensory neuropathy||||0.46
73992859|NCT01637077|147532663|SUPERIORITY|||||||0.86|||||||Kruskal-Wallis|||Autonomic neuropathy||||0.86
73992860|NCT01637077|147532663|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Motor neuropathy||||0.40
73992861|NCT01055704|147532703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.389||0.902|TWO_SIDED|95.0|-0.835|0.739|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.739|-0.835|0.902
73992862|NCT01055704|147532703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.351||0.709|TWO_SIDED|95.0|-0.578|0.841|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.841|-0.578|0.709
73992863|NCT01055704|147532704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.971|STANDARD_ERROR_OF_MEAN|4.669||0.675|TWO_SIDED|95.0|-11.415|7.472|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||7.472|-11.415|0.675
73992864|NCT01055704|147532704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|4.208||0.591|TWO_SIDED|95.0|-10.792|6.233|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||6.233|-10.792|0.591
73992865|NCT01055704|147532705|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-34.425|STANDARD_ERROR_OF_MEAN|14.67||0.024|TWO_SIDED|95.0|-64.097|-4.753|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||-4.753|-64.097|0.024
73992866|NCT01055704|147532705|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.181|STANDARD_ERROR_OF_MEAN|13.24||0.989|TWO_SIDED|95.0|-26.962|26.598|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||26.598|-26.962|0.989
73992867|NCT01055704|147532706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.401|STANDARD_ERROR_OF_MEAN|0.211||0.064|TWO_SIDED|95.0|-0.827|0.025|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.025|-0.827|0.064
73992868|NCT01055704|147532706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.19||0.61|TWO_SIDED|95.0|-0.287|0.482|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.482|-0.287|0.610
73992869|NCT01055704|147532707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.728|STANDARD_ERROR_OF_MEAN|0.497||0.151|TWO_SIDED|95.0|-0.278|1.734|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||1.734|-0.278|0.151
73992870|NCT01055704|147532707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.448||0.806|TWO_SIDED|95.0|-0.795|1.017|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||1.017|-0.795|0.806
73992871|NCT01055704|147532708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.772|STANDARD_ERROR_OF_MEAN|12.583||0.889|TWO_SIDED|95.0|-23.678|27.223|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI as covariates||27.223|-23.678|0.889
73992872|NCT01055704|147532708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.607|STANDARD_ERROR_OF_MEAN|11.356||0.274|TWO_SIDED|95.0|-10.362|35.577|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||35.577|-10.362|0.274
73992873|NCT01055704|147532709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.178||0.236|TWO_SIDED|95.0|-0.572|0.145|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.145|-0.572|0.236
73992874|NCT01055704|147532709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.19||0.885|TWO_SIDED|95.0|-0.412|0.357|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.357|-0.412|0.885
73992875|NCT01055704|147532710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.497|STANDARD_ERROR_OF_MEAN|0.374||0.192|TWO_SIDED|95.0|-1.255|0.261|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.261|-1.255|0.192
73992876|NCT01055704|147532710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.342||0.855|TWO_SIDED|95.0|-0.756|0.63|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.630|-0.756|0.855
73992877|NCT01299480|147532716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992878|NCT01299480|147532716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992879|NCT01299480|147532716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992880|NCT01299480|147532716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992881|NCT01299480|147532716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992882|NCT01299480|147532716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992883|NCT01299480|147532716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992884|NCT01299480|147532716|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992885|NCT01299480|147532718|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992886|NCT01299480|147532718|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992887|NCT01299480|147532718|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992888|NCT01299480|147532718|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
73992889|NCT02296892|147532731|SUPERIORITY||Difference in Rates|0.7588|||<|0.0001|TWO_SIDED|95.0|0.6903|0.8274|||Cochran-Mantel-Haenszel|||||0.8274|0.6903|<0.0001
73992890|NCT01814072|147532743|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73992891|NCT01814072|147532744|SUPERIORITY||Estimated Change|0.1244||||0.567|TWO_SIDED|95.0|-0.3026|0.5513|||Mixed Models Analysis|||||.5513|-.3026|0.567
73992892|NCT01814072|147532744|SUPERIORITY||Estimated Change|-0.0226||||0.917|TWO_SIDED|95.0|-0.4495|0.4044|||Mixed Models Analysis|||||.4044|-.4495|0.917
73992893|NCT01814072|147532744|SUPERIORITY||Estimated Change|0.084||||0.699|TWO_SIDED|95.0|-0.3429|0.5109|||Mixed Models Analysis|||||.5109|-.3429|0.699
73992894|NCT01814072|147532744|SUPERIORITY||Estimated Change|0.1081||||0.619|TWO_SIDED|95.0|-0.3188|0.535|||Mixed Models Analysis|||||.5350|-.3188|0.619
73992895|NCT01814072|147532744|SUPERIORITY||Estimated Change|-0.4353||||0.046|TWO_SIDED|95.0|-0.8622|-0.0084|||Mixed Models Analysis|||||-.0084|-.8622|0.046
73992896|NCT01814072|147532745|OTHER||Estimated Change|0.424||||0.051|TWO_SIDED|95.0|-0.002|0.85|||Mixed Models Analysis|||Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.||0.850|-0.002|0.051
73992897|NCT01011868|147532759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|97.5|-0.78|-0.33||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~* H0,1: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo~* H1,1: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo"||-0.33|-0.78|<0.0001
73992898|NCT01011868|147532759|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|97.5|-0.93|-0.47||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~* H0,2: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo~* H1,2: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo"||-0.47|-0.93|<0.0001
73992899|NCT01011868|147532760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.518|||<|0.0001|TWO_SIDED|95.0|3.262|9.334|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c.||Empagliflozin 10 mg vs Placebo at 18 weeks||9.334|3.262|<0.0001
73992900|NCT01011868|147532760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.883|||<|0.0001|TWO_SIDED|95.0|2.859|8.338|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks||8.338|2.859|<0.0001
73992901|NCT01011868|147532760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.471|||<|0.0001|TWO_SIDED|95.0|2.077|5.802|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks||5.802|2.077|<0.0001
73992902|NCT01011868|147532760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.825|||<|0.0001|TWO_SIDED|95.0|2.268|6.451|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks||6.451|2.268|<0.0001
73992903|NCT01011868|147532760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.802||||0.0002|TWO_SIDED|95.0|1.639|4.789|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks||4.789|1.639|0.0002
73992904|NCT01011868|147532760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.527|||<|0.0001|TWO_SIDED|95.0|2.051|6.066|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks||6.066|2.051|<0.0001
73992905|NCT01011868|147532761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.4|STANDARD_ERROR_OF_MEAN|4.65|<|0.0001|TWO_SIDED|95.0|-37.54|-19.27|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-19.27|-37.54|<0.0001
73992906|NCT01011868|147532761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.21|STANDARD_ERROR_OF_MEAN|4.81|<|0.0001|TWO_SIDED|95.0|-43.67|-24.76|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo at 18 weeks||-24.76|-43.67|<0.0001
73992907|NCT01011868|147532761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.75|STANDARD_ERROR_OF_MEAN|5.02||0.0328|TWO_SIDED|95.0|-20.62|-0.89|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo at 18 weeks||-0.89|-20.62|0.0328
74035567|NCT04047121|147623952|SUPERIORITY||Odds Ratio (OR)|0.7757||||0.4685|TWO_SIDED|95.0|0.3904|1.5413|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5413|0.3904|0.4685
73992908|NCT01011868|147532761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.16|STANDARD_ERROR_OF_MEAN|5.16||0.0002|TWO_SIDED|95.0|-29.31|-9.01|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-9.01|-29.31|0.0002
73992909|NCT01011868|147532761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.03|STANDARD_ERROR_OF_MEAN|5.07||0.3216|TWO_SIDED|95.0|-15.01|4.94|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||4.94|-15.01|0.3216
73992910|NCT01011868|147532761|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.95|STANDARD_ERROR_OF_MEAN|5.23||0.0229|TWO_SIDED|95.0|-22.24|-1.67|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-1.67|-22.24|0.0229
73992911|NCT01011868|147532762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.12|STANDARD_ERROR_OF_MEAN|5.22|<|0.0001|TWO_SIDED|95.0|-35.38|-14.86|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-14.86|-35.38|<0.0001
73992912|NCT01011868|147532762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.01|||<|0.0001|TWO_SIDED|95.0|-41.62|-20.39|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo||-20.39|-41.62|<0.0001
73992913|NCT01011868|147532762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.2|STANDARD_ERROR_OF_MEAN|5.15|<|0.0484|TWO_SIDED|95.0|-20.33|-0.07|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-0.07|-20.33|<0.0484
73992914|NCT01011868|147532762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.42|STANDARD_ERROR_OF_MEAN|5.3||0.0003|TWO_SIDED|95.0|-29.84|-8.99|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-8.99|-29.84|0.0003
73992915|NCT01011868|147532762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.73|STANDARD_ERROR_OF_MEAN|5.07||0.3517||95.0|-14.71|5.25|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||5.25|-14.71|0.3517
74035568|NCT04047121|147623952|SUPERIORITY||Odds Ratio (OR)|0.7354||||0.3112|TWO_SIDED|95.0|0.4057|1.333|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.3330|0.4057|0.3112
74035569|NCT04047121|147623953|SUPERIORITY|||||||0.8122|||||||Log Rank|||||||0.8122
74035570|NCT04047121|147623953|SUPERIORITY|||||||0.7766|||||||Log Rank|||||||0.7766
74035571|NCT04047121|147623953|SUPERIORITY|||||||0.8305|||||||Log Rank|||||||0.8305
73876567|NCT02365649|147294839|SUPERIORITY||Risk Difference (RD)|4.4||||0.721|TWO_SIDED|95.0|-19.5|28.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.2|-19.5|0.721
73876568|NCT02365649|147294839|SUPERIORITY||Risk Difference (RD)|4.8||||1|TWO_SIDED|95.0|-4.3|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||13.9|-4.3|1.000
73876569|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||32.5|-47.5|1.000
73992916|NCT01011868|147532762|SUPERIORITY_OR_OTHER||Adjusted mean difference|-12.39|STANDARD_ERROR_OF_MEAN|5.23||0.0185|TWO_SIDED|95.0|-22.69|-2.1|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-2.10|-22.69|0.0185
73992917|NCT01011868|147532763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.58|STANDARD_ERROR_OF_MEAN|2.4||0.0213|TWO_SIDED|95.0|-10.32|-0.84|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effects.|Empagliflozin versus Placebo 10 mg at 54 weeks||-0.84|-10.32|0.0213
73992918|NCT01011868|147532763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.69|STANDARD_ERROR_OF_MEAN|2.49||0.0237|TWO_SIDED|95.0|-10.62|-0.77|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Empagliflozin versus Placebo 25 mg at 54 weeks||-0.77|-10.62|0.0237
73992919|NCT01011868|147532763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.66|STANDARD_ERROR_OF_MEAN|2.18||0.0024|TWO_SIDED|97.5|-11.56|-1.77||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 10 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo"||-1.77|-11.56|0.0024
73992920|NCT01011868|147532763|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.92|STANDARD_ERROR_OF_MEAN|2.25||0.009|TWO_SIDED|97.5|-11.0|-0.85||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 25 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo"||-0.85|-11.00|0.0090
73992921|NCT01011868|147532764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.04|STANDARD_ERROR_OF_MEAN|0.95||0.032|TWO_SIDED|95.0|-3.9|-0.18|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-0.18|-3.90|0.0320
73992922|NCT01011868|147532764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.99||0.3818|TWO_SIDED|95.0|-2.81|1.08|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 25 mg vs Placebo||1.08|-2.81|0.3818
73992923|NCT01011868|147532764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-2.89|-1.05|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-1.05|-2.89|<0.0001
73992924|NCT01011868|147532764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.17|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-3.13|-1.22|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-1.22|-3.13|<0.0001
73992925|NCT01011868|147532764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.63|STANDARD_ERROR_OF_MEAN|1.1||0.0012|TWO_SIDED|95.0|-5.81|-1.45|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||-1.45|-5.81|0.0012
73992926|NCT01011868|147532764|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.12|STANDARD_ERROR_OF_MEAN|1.15||0.0073|TWO_SIDED|95.0|-5.39|-0.85|||Mixed Models Analysis|Model includes, baseline weight, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects|Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-0.85|-5.39|0.0073
73992927|NCT01011868|147532766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.68|-0.26|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-0.26|-0.68|<0.0001
73876570|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|5.0||||0.765|TWO_SIDED|95.0|-27.8|37.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||37.8|-27.8|0.765
73992928|NCT01011868|147532766|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.95|-0.52|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-0.52|-0.95|<0.0001
73992929|NCT01011868|147532766|NON_INFERIORITY_OR_EQUIVALENCE|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|97.5|-0.73|-0.19||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 10 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo \<0.3%"||-0.19|-0.73|0.0001
73992930|NCT01011868|147532766|NON_INFERIORITY_OR_EQUIVALENCE|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|97.5|-0.9|-0.34||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 25 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo \<0.3%"||-0.34|-0.90|<0.0001
73992931|NCT01011868|147532768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.096||||0.0005|TWO_SIDED|95.0|1.846|9.088|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 18 weeks||9.088|1.846|0.0005
73992932|NCT01011868|147532768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.636||||0.0002|TWO_SIDED|95.0|2.083|10.321|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks||10.321|2.083|0.0002
73992933|NCT01011868|147532768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.1248|TWO_SIDED|95.0|0.856|3.575|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks||3.575|0.856|0.1248
73992934|NCT01011868|147532768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.423||||0.0132|TWO_SIDED|95.0|1.203|4.879|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks||4.879|1.203|0.0132
73992935|NCT01011868|147532768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.939||||0.0986|TWO_SIDED|95.0|0.884|4.256|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks||4.256|0.884|0.0986
73992936|NCT01011868|147532768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.239||||0.0024|TWO_SIDED|95.0|1.518|6.911|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks||6.911|1.518|0.0024
73992937|NCT01782690|147532787|SUPERIORITY_OR_OTHER|||||||0.2361|||||||Log Rank|||Comparison of Rash=Yes versus Rash=No within Erlotinib plus Gemcitabine arm||||0.2361
73992938|NCT04121897|147532810|OTHER|||||||0.024|||||||t-test, 2 sided|||||||0.024
73992939|NCT01948076|147532818|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
73876571|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.4|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||32.4|-42.4|1.000
73992940|NCT01948076|147532819|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|95.0|||||McNemar|||||||0.043
73992941|NCT03732677|147532834|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0005|TWO_SIDED|95.0|1.227|2.084|||Regression, Logistic|Strata adjusted odds ratio by the logistic regression method adjusting for stratification factors: renal function , tumor stage and PDL1 status .||||2.084|1.227|0.0005
73992942|NCT03732677|147532835|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.877|0.554|824.0||Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)||95% CI for hazard ratio: 0.558 - 0.817|0824|0.554|<0.0001
73992943|NCT03732677|147532836|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0021|TWO_SIDED|95.0|0.62|0.9|||Chi-squared|P-value is based on a chi-squared test with one degree of freedom.|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.90|0.62|0.0021
74009248|NCT01380730|147569260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.3|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-52.08|-42.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-42.52|-52.08|<0.001
73992944|NCT03732677|147532837|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0265|TWO_SIDED|95.0|1.047|2.095|||Regression, Logistic|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|Strata adjusted odds ratio by the logistic regression method. Stratified by adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative).|||2.095|1.047|0.0265
73992945|NCT03732677|147532838|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0106|TWO_SIDED|98.457|0.563|0.985|||Log Rank|Stratified by renal function (adequate vs borderline),tumor stage(T2N0vs \>T2N0), PDL1 status(high vs low/negative)|||95% CI: 0.594 to 0.934|0.985|0.563|0.0106
73992946|NCT03732677|147532839|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0002|TWO_SIDED|95.0|0.541|0.826|||Log Rank|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.826|0.541|0.0002
73992947|NCT03732677|147532840|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0081|TWO_SIDED|95.0|0.516|0.907|||Log Rank|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.907|0.516|0.0081
73992948|NCT02065882|147532906|OTHER|Confirmatory t-test testing of the MCF difference (1 h post-dose minus pre-dose)|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73992949|NCT02473965|147532942|SUPERIORITY||Odds Ratio (OR)|0.868|||=|1|TWO_SIDED|95.0|0.27|2.787||The statistical inference was tested as 2-sided with alpha=0.05.|Fisher Exact|||An unstratified analysis using Fisher's exact test was used for treatment comparison without adjustment for stratified baseline prednisone equivalent dose level due to the small cell size. The odds ratio and confidence intervals are calculated overall (i.e. all mITT subjects).||2.787|0.270|=1.00
73992950|NCT02473965|147532943|SUPERIORITY||LS mean difference|1.58|STANDARD_ERROR_OF_MEAN|12.536|=|0.9|TWO_SIDED|95.0|-23.52|26.68|||ANCOVA|||Treatment comparison of percent change in daily CS dose from baseline to Week 39. The Analysis of Covariance model included the percent change from baseline in daily CS dose as the dependent variable, treatment as a fixed effect and baseline daily CS dose as covariate.||26.68|-23.52|=0.900
73992951|NCT00078377|147533001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.0024||95.0|1.02|4.61|||ANCOVA|The corresponding baseline value as a covariate.||Statistical data is for the Armodafinil Combined treatment (250 mg/day and 150 mg/day groups) compared to the placebo treatment group||4.61|1.02|0.0024
73992952|NCT00078377|147533002|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73992953|NCT00953147|147533005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.0001|TWO_SIDED|95.0|0.35|1.04||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.||1.04|0.35|<0.0001
74035572|NCT04047121|147623953|SUPERIORITY||Hazard Ratio (HR)|0.5814||||0.1845|TWO_SIDED|95.0|0.261|1.2952|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.2952|0.2610|0.1845
73876572|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||32.5|-47.5|1.000
73992954|NCT00953147|147533005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54||||0.0005|TWO_SIDED|95.0|0.24|0.84||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.||0.84|0.24|0.0005
73992955|NCT00953147|147533006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0014|TWO_SIDED|95.0|0.25|0.92|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.92|0.25|0.0014
73992956|NCT00953147|147533006|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.42||||0.0122|TWO_SIDED|95.0|0.12|0.72|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.72|0.12|0.0122
73992957|NCT00475644|147533047|SUPERIORITY||Odds Ratio (OR)|0.031|||||TWO_SIDED|95.0|0.001|0.86||||||||0.860|0.001|
73992958|NCT01411241|147533048|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% Confidence Interval (CI) of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-diphtheria. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
73992959|NCT01411241|147533048|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.14|2.07||||||Non-inferiority (Group 1 - Group 2); Anti-tetanus. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.07|-1.14|
74035573|NCT04047121|147623953|SUPERIORITY||Hazard Ratio (HR)|1.5908||||0.2951|TWO_SIDED|95.0|0.6671|3.7936|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.7936|0.6671|0.2951
73876573|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|11.3||||0.502|TWO_SIDED|95.0|-21.4|43.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||43.9|-21.4|0.502
73876574|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-32.9|42.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||42.9|-32.9|1.000
73876575|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-2.5||||1|TWO_SIDED|95.0|-42.3|37.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||37.3|-42.3|1.000
73876576|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|22.5||||0.18|TWO_SIDED|95.0|-9.5|54.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||54.5|-9.5|0.180
73992960|NCT01411241|147533048|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.14|2.08||||||Non-inferiority (Group 1 - Group 2); Anti-polio 1. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.08|-1.14|
74035574|NCT04047121|147623953|SUPERIORITY||Hazard Ratio (HR)|1.3546||||0.4907|TWO_SIDED|95.0|0.6584|2.787|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.7870|0.6584|0.4907
74035575|NCT04047121|147623954|SUPERIORITY|||||||0.6006|||||||Log Rank|||||||0.6006
73876577|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-10.0||||0.702|TWO_SIDED|95.0|-45.6|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||25.6|-45.6|0.702
73876578|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-27.5||||0.214|TWO_SIDED|95.0|-58.9|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||3.9|-58.9|0.214
73876579|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|28.8||||0.086|TWO_SIDED|95.0|-2.5|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.0|-2.5|0.086
73992961|NCT01411241|147533048|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-polio 2. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
73992962|NCT01411241|147533048|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.15|2.09||||||Non-inferiority (Group 1 - Group 2); Anti-polio 3. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.09|-1.15|
74035576|NCT04047121|147623954|SUPERIORITY|||||||0.2941|||||||Log Rank|||||||0.2941
74035577|NCT04047121|147623954|SUPERIORITY|||||||0.961|||||||Log Rank|||||||0.9610
74035578|NCT04047121|147623954|SUPERIORITY||Hazard Ratio (HR)|0.5571||||0.0455|TWO_SIDED|95.0|0.314|0.9884|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||0.9884|0.3140|0.0455
74035579|NCT04047121|147623954|SUPERIORITY||Hazard Ratio (HR)|2.1781||||0.0274|TWO_SIDED|95.0|1.0904|4.3506|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||4.3506|1.0904|0.0274
74035580|NCT04047121|147623954|SUPERIORITY||Hazard Ratio (HR)|0.8896||||0.6787|TWO_SIDED|95.0|0.5114|1.5475|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5475|0.5114|0.6787
74035581|NCT04047121|147623955|SUPERIORITY|||||||0.9084|||||||Log Rank|||||||0.9084
74035582|NCT04047121|147623955|SUPERIORITY|||||||0.8325|||||||Log Rank|||||||0.8325
74035583|NCT04047121|147623955|SUPERIORITY|||||||0.963|||||||Log Rank|||||||0.9630
74090050|NCT02655016|147733225|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.2242|TWO_SIDED|95.0|0.577|1.139||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||1.139|0.577|0.2242
73992963|NCT01411241|147533048|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-PRP. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
74035584|NCT04047121|147623955|SUPERIORITY||Hazard Ratio (HR)|1.0508||||0.7909|TWO_SIDED|95.0|0.7284|1.516|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5160|0.7284|0.7909
73992964|NCT01411241|147533048|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.56|||||TWO_SIDED|95.0|-3.93|2.69||||||Non-inferiority (Group 1 - Group 2); Anti-PT. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.69|-3.93|
73992965|NCT01411241|147533048|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.36|||||TWO_SIDED|95.0|-4.87|4.06||||||Non-inferiority (Group 1 - Group 2); Anti-FHA. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||4.06|-4.87|
73992966|NCT02980042|147533058|SUPERIORITY||Risk Ratio (RR)|0.6616||||0.1996|TWO_SIDED|95.0|0.3666|1.1942|||Generalized estimating equations|GEE was necessary because there are repeated measures on subjects.|This is comparing the Switching group to the Comparator group|||1.1942|.3666|0.1996
73992967|NCT02980042|147533059|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.5299|1.8872|||Generalized estimating equations|GEE was used because there are repeated measures on subjects|Comparing Switching group Day 1 to combined Comparator group|||1.8872|.5299|1.0000
73992968|NCT02980042|147533059|SUPERIORITY||Risk Ratio (RR)|0.2857||||0.0053|TWO_SIDED|95.0|0.1006|0.8114|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.|Switching group Day 15 was compared to combined Comparator group.|||.8114|.1006|0.0053
73992969|NCT02980042|147533059|SUPERIORITY||Risk Ratio (RR)|0.8571||||0.6474|TWO_SIDED|95.0|0.4385|1.6753|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||1.6753|.4385|0.6474
74090051|NCT00380692|147733317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-10.0|-3.4||P-value for treatment group differences over time.|Mixed Models Analysis|||||-3.4|-10.0|<0.001
73992970|NCT02980042|147533063|SUPERIORITY||Risk Ratio (RR)|0.2857||||0.0075|TWO_SIDED|95.0|0.1072|0.7613|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||.7613|.1072|0.0075
73992971|NCT02980042|147533063|SUPERIORITY||Risk Ratio (RR)|0.8571||||0.593|TWO_SIDED|95.0|0.4868|1.5093|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||1.5093|.4868|0.5930
73992972|NCT02980042|147533063|SUPERIORITY||Risk Ratio (RR)|3.0||||0.0209|TWO_SIDED|95.0|1.126|7.9932|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||7.9932|1.1260|0.0209
73992973|NCT02980042|147533068|OTHER||Mean Difference (Net)|0.0||||0.005|TWO_SIDED|95.0|-27.05|-5.01||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.01|-27.05|0.005
73992974|NCT02980042|147533069|OTHER||Mean Difference (Net)|2.55|||<|0.0001|TWO_SIDED|95.0|1.54|3.56||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||3.56|1.54|<0.0001
73992975|NCT02980042|147533070|OTHER||Median Difference (Net)|8.58|||<|0.0001|TWO_SIDED|95.0|6.33|10.82||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||10.82|6.33|<0.0001
73992976|NCT02980042|147533071|OTHER||Mean Difference (Net)|-7.37|||<|0.0001|TWO_SIDED|95.0|-10.19|-4.55||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.55|-10.19|<0.0001
74035585|NCT04047121|147623955|SUPERIORITY||Hazard Ratio (HR)|0.8117||||0.6027|TWO_SIDED|95.0|0.37|1.7808|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7808|0.3700|0.6027
74090052|NCT00380692|147733318|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.921||95.0|-0.5|0.4||P-value for treatment differences over time.|Mixed Models Analysis|||||0.4|-0.5|0.921
74090053|NCT00380692|147733319|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.61||0.369||95.0|-1.8|0.7||P-value for treatment differences in Oppositional Score at 8 weeks.|ANCOVA|||||0.7|-1.8|0.369
73992977|NCT02980042|147533072|OTHER||Mean Difference (Net)|44.32|||<|0.0001|TWO_SIDED|95.0|29.59|59.05||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||59.05|29.59|<0.0001
73992978|NCT02980042|147533073|OTHER||Mean Difference (Net)|353.35||||0.0002|TWO_SIDED|95.0|175.23|531.46||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||531.46|175.23|0.0002
73992979|NCT02980042|147533074|OTHER||Mean Difference (Net)|176.9|||<|0.0001|TWO_SIDED|95.0|124.5|229.31||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||229.31|124.50|<0.0001
73992980|NCT02980042|147533075|OTHER||Mean Difference (Net)|0.19||||0.002|TWO_SIDED|95.0|0.07|0.32||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.32|0.07|0.0020
73992981|NCT02980042|147533076|OTHER||Mean Difference (Net)|0.55|||<|0.0001|TWO_SIDED|95.0|0.32|0.77||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.77|0.32|<0.0001
73992982|NCT02980042|147533077|OTHER||Mean Difference (Net)|-46.16||||0.0091|TWO_SIDED|95.0|-80.61|-11.72||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-11.72|-80.61|0.0091
73992983|NCT02980042|147533078|OTHER||Mean Difference (Net)|55.26||||0.0002|TWO_SIDED|95.0|27.0|83.52||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||83.52|27.00|0.0002
73992984|NCT02980042|147533079|OTHER||Mean Difference (Net)|-17.24||||0.0044|TWO_SIDED|95.0|-28.96|-5.51||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.51|-28.96|0.0044
73992985|NCT02980042|147533080|OTHER||Mean Difference (Net)|16.01|||<|0.0001|TWO_SIDED|95.0|9.75|22.28||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||22.28|9.75|<0.0001
73992986|NCT02980042|147533081|OTHER||Mean Difference (Net)|429.08|||<|0.0001|TWO_SIDED|95.0|296.07|562.1||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||562.10|296.07|<0.0001
74090054|NCT00380692|147733319|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|0.87||0.024||95.0|-3.7|-0.3||P-value for treatment differences in Hyperactivity score at 8 weeks|ANCOVA|||||-0.3|-3.7|0.024
73992987|NCT02980042|147533082|OTHER||Mean Difference (Net)|1.23||||0.0101|TWO_SIDED|95.0|0.3|2.16||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.16|0.30|0.0101
73992988|NCT02980042|147533083|OTHER||Mean Difference (Net)|8.69|||<|0.0001|TWO_SIDED|95.0|4.87|12.52||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||12.52|4.87|<0.0001
73992989|NCT02980042|147533084|OTHER||Mean Difference (Net)|1.53|||<|0.0001|TWO_SIDED|95.0|1.04|2.03||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.03|1.04|<0.0001
73992990|NCT02980042|147533085|OTHER||Mean Difference (Net)|-33.17|||<|0.0001|TWO_SIDED|95.0|-38.91|-27.44||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-27.44|-38.91|<0.0001
73992991|NCT02980042|147533086|OTHER||Mean Difference (Net)|-0.62||||0.0008|TWO_SIDED|95.0|-0.98|-0.26||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.26|-0.98|0.0008
73992992|NCT02980042|147533087|OTHER||Mean Difference (Net)|2.01|||<|0.0001|TWO_SIDED|95.0|1.23|2.79||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.79|1.23|<0.0001
74090055|NCT00380692|147733319|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.51||0.179||95.0|-1.7|0.3||P-value for treatment differences in Cognititve/Attention score at 8 weeks.|ANCOVA|||||0.3|-1.7|0.179
74090056|NCT00380692|147733319|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.48||0.077||95.0|-5.6|0.3||P-value for treatment differences in ADHD score at 8 weeks|ANCOVA|||||0.3|-5.6|0.077
73992993|NCT02980042|147533088|OTHER||Mean Difference (Net)|-7.84|||<|0.0001|TWO_SIDED|95.0|-9.87|-5.81||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.81|-9.87|<0.0001
73992994|NCT02980042|147533089|OTHER||Mean Difference (Net)|-14.2||||0.0022|TWO_SIDED|95.0|-23.15|-5.25||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.25|-23.15|0.0022
73992995|NCT02980042|147533090|OTHER||Mean Difference (Net)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.43||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.43|0.17|<0.0001
73992996|NCT02980042|147533091|OTHER||Mean Difference (Net)|0.41|||<|0.0001|TWO_SIDED|95.0|0.22|0.61||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.61|0.22|<0.0001
73992997|NCT02980042|147533092|OTHER||Mean Difference (Net)|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.5||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.50|-0.95|<0.0001
73992998|NCT02980042|147533093|OTHER||Mean Difference (Net)|-19.31|||<|0.0001|TWO_SIDED|95.0|-22.64|-15.98||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-15.98|-22.64|<0.0001
73992999|NCT02980042|147533094|OTHER||Mean Difference (Net)|-6.96|||<|0.0001|TWO_SIDED|95.0|-9.85|-4.08||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.08|-9.85|<0.0001
73993000|NCT02980042|147533095|OTHER||Mean Difference (Net)|-23.22||||0.0061|TWO_SIDED|95.0|-39.66|-6.78||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-6.78|-39.66|0.0061
73993001|NCT02980042|147533096|OTHER||Mean Difference (Net)|-5.69|||<|0.0001|TWO_SIDED|95.0|-7.24|-4.14||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.14|-7.24|<0.0001
73993002|NCT02980042|147533097|OTHER||Mean Difference (Net)|-0.84||||0.0077|TWO_SIDED|95.0|-1.45|-0.23||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.23|-1.45|0.0077
74009249|NCT01380730|147569260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.75|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-39.53|-29.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.97|-39.53|<0.001
74009250|NCT01380730|147569260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.93|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-48.36|-37.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-37.50|-48.36|<0.001
74009251|NCT01380730|147569260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.4|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-47.81|-36.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-36.98|-47.81|<0.001
74009252|NCT01380730|147569260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.77|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-39.2|-28.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-28.33|-39.20|<0.001
74009253|NCT00119041|147569261|SUPERIORITY_OR_OTHER||||||>|0.153|TWO_SIDED|||||Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|||Comparisons were made between the intervention and control groups at baseline||||>0.153
74009254|NCT00119041|147569261|SUPERIORITY_OR_OTHER||||||>|0.25|TWO_SIDED|||||Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.||Comparisons were made between the intervention and control groups at 18 months||||>0.25
74009255|NCT01195090|147569320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.165|TWO_SIDED|95.0|-0.58|0.08||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor 'treatment' and baseline A1C as covariate.|ANCOVA|||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor 'treatment' and baseline A1C as covariate.||0.08|-0.58|0.165
74009256|NCT01195090|147569336|NON_INFERIORITY_OR_EQUIVALENCE|Chi-square test|Chi-Square|0.0034||||0.954||||||Chi-square test|Chi-squared|||Chi-square test for percentages of patient achieving an A1C \<7%||||0.954
73993003|NCT02980042|147533098|OTHER||Mean Difference (Net)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.27||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.27|-0.37|<0.0001
73993004|NCT00725270|147533099|SUPERIORITY_OR_OTHER|||||||0.812|||||||Mixed Models Analysis|||Repeated Measures ANOVA was run on the Positive Symptom Scale of the Brief Psychiatric Rating Scale, using Baseline and Day 9 ratings. Below is the medication \* time interaction.||||.812
73993005|NCT00725270|147533100|SUPERIORITY_OR_OTHER||eta sq|0.157||||0.203|TWO_SIDED||||||Mixed Models Analysis|||||||.203
73993006|NCT01020877|147533104|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test\[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.0|||||TWO_SIDED|90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||117|103|
73993007|NCT01020877|147533105|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||TWO_SIDED|90.0|98.2|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115|98.2|
73993008|NCT01020877|147533106|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||TWO_SIDED|90.0|97.6|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115|97.6|
73993009|NCT00790400|147533107|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Clopper-Pearson|||||||<0.0001
73993010|NCT00078338|147533120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.943||||0.643|TWO_SIDED|95.0|0.74|1.21|||Cox proportional hazards model|||||1.21|0.74|0.643
73993011|NCT04292470|147533121|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
73993012|NCT04292470|147533122|SUPERIORITY|||||||0.09|||||||ANOVA|||For statistical testing, we used a general linear model of change in GERD symptoms from baseline to 8 weeks adjusted for the natural log of the index value (of the ratio of the change in skin conductance between patient and physician at baseline) and randomization assignment.||||0.09
73993013|NCT02906020|147533137|SUPERIORITY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.87|=|0.1679|TWO_SIDED|95.0|-1.1|6.27||The threshold for statistical significance was 0.05.|MMRM|||Least-squares (LS) mean, standard errors (SE) and p-value were estimated from mixed-effect model with repeated measures (MMRM) analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time point interaction.||6.27|-1.10|=0.1679
73993014|NCT02906020|147533138|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|1.85|=|0.5996|TWO_SIDED|95.0|-4.63|2.68||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value were estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time point interaction.||2.68|-4.63|=0.5996
73993015|NCT02906020|147533139|SUPERIORITY||LS mean difference|4.13|STANDARD_ERROR_OF_MEAN|2.13|=|0.0535|TWO_SIDED|95.0|-0.06|8.32||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value were estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time-interaction||8.32|-0.06|=0.0535
74009257|NCT05111041|147569349|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.302|3.309||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.309|0.302|1.000
74009258|NCT05111041|147569350|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7389|TWO_SIDED|95.0|0.215|2.972||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||2.972|0.215|0.7389
74009259|NCT05111041|147569352|SUPERIORITY||Odds Ratio (OR)|1.306||||0.6058|TWO_SIDED|95.0|0.474|3.602||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.602|0.474|0.6058
74009260|NCT05111041|147569353|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.349|2.866||||||||2.866|0.349|
74009261|NCT05111041|147569354|SUPERIORITY||Odds Ratio (OR)|1.333||||0.5925|TWO_SIDED|95.0|0.465|3.823||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.823|0.465|0.5925
74009262|NCT01205230|147569355|SUPERIORITY_OR_OTHER||Ratio of least square geometric means|1.66|||||TWO_SIDED|90.0|1.39|1.99|||||Ratio of least square (LS) geometric means (Pazopanib + Ketoconozole : Pazopanib alone)|||1.99|1.39|
74009263|NCT01205230|147569355|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|0.6|||||TWO_SIDED|90.0|0.52|0.7|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)|||0.70|0.52|
74009264|NCT01205230|147569356|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|1.45|||||TWO_SIDED|90.0|1.14|1.86|||||Ratio of LS geometric means (Pazopanib + Ketoconozole : Pazopanib alone)|||1.86|1.14|
74009265|NCT01205230|147569356|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|0.58|||||TWO_SIDED|90.0|0.5|0.67|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)|||0.67|0.50|
74009266|NCT01205230|147569357|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.45|||||TWO_SIDED|90.0|-1.06|0.06||||||||0.06|-1.06|
74009267|NCT01205230|147569357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|||||TWO_SIDED|90.0|-0.1|2.44||||||||2.44|-0.10|
73876580|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-37.2|37.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||37.2|-37.2|1.000
73876581|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|7.5||||1|TWO_SIDED|95.0|-31.6|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||46.6|-31.6|1.000
73876582|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|32.5||||0.051|TWO_SIDED|95.0|1.4|63.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||63.6|1.4|0.051
73993016|NCT02906020|147533140|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.08|=|0.74|TWO_SIDED|95.0|-0.12|0.17||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value: estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time-interaction.||0.17|-0.12|=0.7400
73993017|NCT02179177|147533144|OTHER||Mean Difference (Net)|1.0||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
74090057|NCT00380692|147733321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.028||95.0|-1.0|-0.1||P-value for treatment differences in Time to fall asleep score at 8 weeks.|ANCOVA|||||-0.1|-1.0|0.028
73876583|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-34.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||34.8|-34.8|1.000
73876584|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||60.0|-5.0|0.075
73876585|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-3.7||||0.705|TWO_SIDED|95.0|-18.6|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||11.2|-18.6|0.705
73993018|NCT01634269|147533150|SUPERIORITY_OR_OTHER_LEGACY||Proportion of IF implanted subjects|87.5||||0.002|TWO_SIDED|95.0|61.7|98.4|||Exact binomial|||||98.4|61.7|0.002
73876586|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-20.0|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||12.4|-20.0|1.000
73993019|NCT01516749|147533232|SUPERIORITY_OR_OTHER|||||||0.024||||||significance was accepted at p\<0.05|t-test, 2 sided|||Significance of decrease in modified Sartorius score from Baseline to 8 weeks||||0.024
73993020|NCT01516749|147533233|SUPERIORITY_OR_OTHER|||||||0.006||||||Significance was accepted at p\<0.05|t-test, 2 sided|||Significance of reductions in Physican Global Assessment mean values between baseline and 8 weeks of therapy||||0.006
73993021|NCT01516749|147533233|SUPERIORITY_OR_OTHER|||||||0.019||||||Significance was accepted at p\<0.05|t-test, 2 sided|||Significance of reductions in Patient Global Assessment mean values between baseline and 8 weeks of therapy||||0.019
73993022|NCT01607879|147533236|SUPERIORITY|||||||0.1497|||||||t-test, 1 sided|||||||0.1497
73993023|NCT01607879|147533237|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
73993024|NCT01607879|147533238|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
73993025|NCT01607879|147533239|SUPERIORITY|||||||0.925|||||||Wilcoxon (Mann-Whitney)|||||||0.925
74090058|NCT00380692|147733321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.407||95.0|-0.3|0.9||P-value for treatment differences in Difficulty falling asleep score at 8 weeks.|ANCOVA|||||0.9|-0.3|0.407
73993026|NCT01607879|147533240|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
73993027|NCT03994731|147533241|SUPERIORITY||Stratified difference in proportions|32.31|STANDARD_ERROR_OF_MEAN|8.157|<|0.0001|TWO_SIDED|95.0|16.3|48.3||The 2-sided p-value was calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (Pegloticase+MTX - Pegloticase+Placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tophi presence at baseline: yes, no) were combined with Cochran-Mantel-Haenszel (CMH) weights.|||48.3|16.3|< 0.0001
73993028|NCT03994731|147533242|SUPERIORITY||response rate difference|29.05|STANDARD_ERROR_OF_MEAN|8.084||0.0003|TWO_SIDED|95.0|13.2|44.9||The 2-sided p-value was calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||response rate difference (Peg+MTX - Peg+Placebo)|||44.9|13.2|0.0003
74009268|NCT00922480|147569366|NON_INFERIORITY|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test||||||0.0001
74090059|NCT00380692|147733321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.652||95.0|-0.6|0.4||P-value for treatment differences in Total hours of sleep score at 8 weeks.|ANCOVA|||||0.4|-0.6|0.652
74090060|NCT00380692|147733321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.49||0.112||95.0|-1.7|0.2||P-value for treatment differences in Quality of sleep score at 8 weeks.|ANCOVA|||||0.2|-1.7|0.112
73876587|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||60.0|-5.0|0.075
73876588|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-3.7||||0.705|TWO_SIDED|95.0|-18.6|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||11.2|-18.6|0.705
73876589|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|0.5||||1|TWO_SIDED|95.0|-17.4|18.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||18.5|-17.4|1.000
73876590|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.8|-20.5|1.000
73876591|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-6.4||||0.348|TWO_SIDED|95.0|-18.0|5.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||5.2|-18.0|0.348
73993029|NCT03994731|147533243|SUPERIORITY||Difference|22.8||||0.0482|TWO_SIDED|95.0|1.2|44.4||The comparison of complete response between groups is performed using an unstratified chi-squared test.|Chi-squared||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||44.4|1.2|0.0482
74035586|NCT04047121|147623955|SUPERIORITY||Hazard Ratio (HR)|1.1742||||0.6978|TWO_SIDED|95.0|0.5222|2.6404|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.6404|0.5222|0.6978
74035587|NCT04047121|147623956|SUPERIORITY|||||||0.1736|||||||Log Rank|||||||0.1736
73876592|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||20.7|-13.4|0.686
73876593|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|7.5||||0.616|TWO_SIDED|95.0|-19.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||34.8|-19.8|0.616
73876594|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-6.6||||0.42|TWO_SIDED|95.0|-20.5|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||7.3|-20.5|0.420
73876595|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-20.0|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||12.4|-20.0|1.000
73876596|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||21.8|-20.5|1.000
73993030|NCT03994731|147533244|SUPERIORITY||Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.084||0.6287|TWO_SIDED|95.0|-0.21|0.13||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||0.13|-0.21|0.6287
73876597|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-0.6||||1|TWO_SIDED|95.0|-14.4|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||13.3|-14.4|1.000
74035588|NCT04047121|147623956|SUPERIORITY|||||||0.0195|||||||Log Rank|||||||0.0195
74035589|NCT04047121|147623956|SUPERIORITY|||||||0.2104|||||||Log Rank|||||||0.2104
74035590|NCT04047121|147623956|SUPERIORITY||Hazard Ratio (HR)|1.1723||||0.167|TWO_SIDED|95.0|0.9357|1.4687|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.4687|0.9357|0.1670
74035591|NCT04047121|147623956|SUPERIORITY||Hazard Ratio (HR)|0.7228||||0.1087|TWO_SIDED|95.0|0.4861|1.0747|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.0747|0.4861|0.1087
73876598|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||20.7|-13.4|0.686
73876599|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|9.4||||0.555|TWO_SIDED|95.0|-21.9|40.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||40.6|-21.9|0.555
73876600|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-2.7||||0.83|TWO_SIDED|95.0|-27.2|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||21.8|-27.2|0.830
73876601|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-9.0||||0.518|TWO_SIDED|95.0|-36.0|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||17.9|-36.0|0.518
73993031|NCT03994731|147533245|SUPERIORITY||Difference|-8.43|STANDARD_ERROR_OF_MEAN|3.766||0.0272|TWO_SIDED|95.0|-15.88|-0.97||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||-0.97|-15.88|0.0272
73993032|NCT03994731|147533246|SUPERIORITY||Difference|-10.16|STANDARD_ERROR_OF_MEAN|2.531||0.0222|TWO_SIDED|95.0|-18.84|-1.48||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||-1.48|-18.84|0.0222
73993033|NCT02838979|147533257|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.34||0.15|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.15
73993034|NCT02838979|147533258|SUPERIORITY||Mean Difference (Final Values)|-7.39|STANDARD_DEVIATION|22.18||0.86|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.86
73993035|NCT02838979|147533259|SUPERIORITY||Median Difference (Final Values)|-0.1|STANDARD_DEVIATION|1.04||0.44|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.44
73993036|NCT02838979|147533260|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.21||0.36|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.36
73993037|NCT02838979|147533261|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_DEVIATION|7.87||0.6|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.60
73993038|NCT00609947|147533262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.2|STANDARD_DEVIATION|21.8|<|0.001|ONE_SIDED|95.0||||"The null and alternative hypotheses were:~H0: µSVS ≥µM H1: µSVS \< µM where µSVS was the mean in-segment 8-month percent diameter stenosis for the SVS study and µM was the mean in-segment 6-month percent diameter stenosis for Micro-Driver."|t-test, 2 sided|The sample size was not reduced below 158 evaluable subjects in order to support the analysis of the primary safety endpoint.||The 8-month in-segment percent diameter stenosis from Endeavor SVS subjects was compared to the 6-month in-segment percent diameter stenosis from Micro Driver subjects. This study assessed the superiority of SVS against the Micro-Driver regarding in-segment percent diameter stenosis at 8 months post procedure.||||<0.001
73993039|NCT00609947|147533263|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|13.5|STANDARD_ERROR_OF_MEAN|6.5||0.0041|ONE_SIDED|95.0||20.0|||t-test, 1 sided|||"The null and alternative hypotheses of interest are:~H0: xSVS \>= 20% vs. H1: xSVS \< 20%, where x is the true SVS 12-month MACE rate.~The assessment of the null hypothesis will be carried out at the one-sided 0.05 level of significance. Rejection of the null hypothesis indicates the SVS 12-month MACE rate is significantly below 20%."||20||0.0041
73993040|NCT01304498|147533264|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16||1.11|0.85|<0.001
73993041|NCT01304498|147533264|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.91|1.29|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18||1.29|0.91|<0.001
73993042|NCT04937920|147533277|OTHER||Mean Paired Change from Baseline|-29620.0||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 5 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||0.2
73993043|NCT04937920|147533277|OTHER||Mean Paired Change from Baseline|127195.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 14 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||1.0
73993044|NCT04937920|147533277|OTHER||Mean Paired Change from Baseline|-41659.0||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 5 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||0.6
74009269|NCT00922480|147569367|NON_INFERIORITY|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test||||||0.0001
73993045|NCT04937920|147533277|OTHER||Mean Paired Change from Baseline|-483.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 14 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||1.0
73993046|NCT01667549|147533283|OTHER|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).||||||0.02||||||Bonferroni adjustment was made and only planned pairwise comparisons with calculated p values of 0.02 or lower significant.|planned comparison|Bonferroni adjustment was calculated and only planned pair-wise comparisons with calculated p value 0.02 or lower were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||0.02
73993047|NCT01667549|147533284|OTHER||||||<|0.02|||||||ANOVA|||Repeated measures ANOVAs were conducted on maternal gLMS ratings with type of juice and time as the within-subject factors and experimental group as the grouping factor||||<0.02
73993048|NCT01667549|147533285|OTHER|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).|||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.|planned comparison|a Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||<0.02
73993049|NCT01667549|147533286|OTHER||||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P\<0.02 were considered significant.|planned comparison|A Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||<0.02
73993050|NCT01667549|147533287|OTHER||||||<|0.05|||||||ANOVA|||General linear models were conducted on WLZ scores with time as the within-subjects factor and Group as the between-subjects factor to determine there were differences in growth of the infants over time. This was not done to test hypothesis but to monitor growth of infants during course of trial.||||<0.05
73993051|NCT02844777|147533288|OTHER|||||||0.9518|||||||ANCOVA|||||||0.9518
73993052|NCT02844777|147533288|OTHER|||||||0.2458|||||||ANCOVA|||||||0.2458
73993053|NCT02844777|147533289|OTHER|||||||0.6201|||||||Fisher Exact|||||||0.6201
74090061|NCT00380692|147733321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.87||0.188||95.0|-2.9|0.6||P-value for treatment differences in Functional outcome during day score at 8 weeks.|ANCOVA|||||0.6|-2.9|0.188
73993054|NCT02844777|147533289|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73993055|NCT02844777|147533290|OTHER|||||||0.2912|||||||ANCOVA|||||||0.2912
73993056|NCT02844777|147533290|OTHER|||||||0.4168|||||||ANCOVA|||||||0.4168
73993057|NCT02844777|147533291|OTHER|||||||0.6458|||||||ANCOVA|||||||0.6458
73993058|NCT02844777|147533291|OTHER|||||||0.0721|||||||ANCOVA|||||||0.0721
73993059|NCT02844777|147533292|OTHER|||||||0.42|||||||ANCOVA|||||||0.4200
73993060|NCT02844777|147533292|OTHER|||||||0.0241|||||||ANCOVA|||||||0.0241
73993061|NCT04092452|147533293|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|9.69||0.4696|TWO_SIDED|90.0|-15.2|16.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||16.7|-15.2|0.4696
74009270|NCT04784897|147569368|SUPERIORITY||Cox Proportional Hazard|0.9289||||0.7273|TWO_SIDED|90.0|0.6585|1.3102|||Log Rank|||Main comparison is between Brilacidin 5-dose and Pooled Placebo||1.3102|0.6585|0.7273
74009271|NCT04784897|147569368|SUPERIORITY||Cox Proportional Hazard|0.8968||||0.5975|TWO_SIDED|90.0|0.5464|1.472|||Log Rank|||Secondary comparison between Brilacidin 3-dose and Pooled Placebo||1.4720|0.5464|0.5975
74009272|NCT04667377|147569396|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
73876602|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|12.5||||0.428|TWO_SIDED|95.0|-18.6|43.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||43.6|-18.6|0.428
73876603|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|3.9||||0.757|TWO_SIDED|95.0|-20.7|28.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||28.4|-20.7|0.757
73876604|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|4.6||||0.745|TWO_SIDED|95.0|-23.2|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||32.4|-23.2|0.745
73876605|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-5.8||||1|TWO_SIDED|95.0|-34.6|23.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.0|-34.6|1.000
73876606|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|3.6||||0.773|TWO_SIDED|95.0|-20.6|27.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||27.7|-20.6|0.773
73876607|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-2.8||||0.838|TWO_SIDED|95.0|-29.4|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-29.4|0.838
73993062|NCT04092452|147533293|SUPERIORITY||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|9.71||0.0298|TWO_SIDED|90.0|2.7|34.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||34.6|2.7|0.0298
73993063|NCT04092452|147533293|SUPERIORITY||Risk Difference (RD)|3.5|STANDARD_ERROR_OF_MEAN|9.79||0.3606|TWO_SIDED|90.0|-12.6|19.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||19.6|-12.6|0.3606
73876608|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-12.9||||0.497|TWO_SIDED|95.0|-40.0|14.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||14.1|-40.0|0.497
73876609|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|10.5||||0.404|TWO_SIDED|95.0|-14.0|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||34.9|-14.0|0.404
73876610|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-2.8||||0.838|TWO_SIDED|95.0|-29.4|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.8|-29.4|0.838
73876611|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|3.6||||1|TWO_SIDED|95.0|-24.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||31.6|-24.4|1.000
73876612|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|16.4||||0.174|TWO_SIDED|95.0|-7.0|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||39.8|-7.0|0.174
73876613|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|6.6||||0.611|TWO_SIDED|95.0|-19.1|32.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||32.3|-19.1|0.611
74090062|NCT00380692|147733322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|1.29||0.452||95.0|-3.5|1.6||P-value for treatment differences in Irritability score at 8 weeks.|ANCOVA|||||1.6|-3.5|0.452
74090063|NCT00380692|147733322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|1.1||0.85||95.0|-2.4|2.0||P-value for treatment differences in Lethargy score at 8 weeks.|ANCOVA|||||2.0|-2.4|0.850
73876614|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|1.000
73876615|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-5.0||||0.488|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|0.488
73876616|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|1.000
73993064|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|-3.8|STANDARD_ERROR_OF_MEAN|7.19|||TWO_SIDED|90.0|-15.6|8.0||||||Week 1||8.0|-15.6|
73993065|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|7.28|||TWO_SIDED|90.0|-12.9|11.1||||||Week 1||11.1|-12.9|
73993066|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|4.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|90.0|-8.5|17.8||||||Week 1||17.8|-8.5|
73993067|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|7.9|STANDARD_ERROR_OF_MEAN|9.02|||TWO_SIDED|90.0|-6.9|22.8||||||Week 2||22.8|-6.9|
73993068|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|7.5|STANDARD_ERROR_OF_MEAN|8.91|||TWO_SIDED|90.0|-7.1|22.2||||||Week 2||22.2|-7.1|
73993069|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|3.5|STANDARD_ERROR_OF_MEAN|9.0|||TWO_SIDED|90.0|-11.3|18.3||||||Week 2||18.3|-11.3|
73993070|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|9.0|STANDARD_ERROR_OF_MEAN|9.79|||TWO_SIDED|90.0|-7.1|25.1||||||Week 4||25.1|-7.1|
73993071|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|7.7|STANDARD_ERROR_OF_MEAN|9.57|||TWO_SIDED|90.0|-8.0|23.5||||||Week 4||23.5|-8.0|
73993072|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|9.37|||TWO_SIDED|90.0|-19.4|11.4||||||Week 4||11.4|-19.4|
73993073|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|0.8|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|90.0|-15.6|17.2||||||Week 6||17.2|-15.6|
73993074|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|6.7|STANDARD_ERROR_OF_MEAN|9.81|||TWO_SIDED|90.0|-9.4|22.9||||||Week 6||22.9|-9.4|
73993075|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|3.7|STANDARD_ERROR_OF_MEAN|10.05|||TWO_SIDED|90.0|-12.8|20.2||||||Week 6||20.2|-12.8|
73993076|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|-7.8|STANDARD_ERROR_OF_MEAN|9.98||0.7798|TWO_SIDED|90.0|-24.2|8.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||8.7|-24.2|0.7798
73876617|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
73876618|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-5.0||||0.488|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|0.488
73993077|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|9.92||0.4819|TWO_SIDED|90.0|-15.9|16.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||16.8|-15.9|0.4819
73993078|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|10.19||0.5933|TWO_SIDED|90.0|-19.2|14.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||14.4|-19.2|0.5933
73993079|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|-9.9|STANDARD_ERROR_OF_MEAN|9.81||0.8421|TWO_SIDED|90.0|-26.1|6.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||6.2|-26.1|0.8421
73993080|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|8.0|STANDARD_ERROR_OF_MEAN|9.85||0.209|TWO_SIDED|90.0|-8.2|24.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||24.2|-8.2|0.2090
73993081|NCT04092452|147533294|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|10.12||0.5183|TWO_SIDED|90.0|-17.1|16.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||16.2|-17.1|0.5183
73993082|NCT04092452|147533295|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|7.54||0.515|TWO_SIDED|90.0|-12.7|12.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||12.1|-12.7|0.5150
73993083|NCT04092452|147533295|SUPERIORITY||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|8.28||0.0737|TWO_SIDED|90.0|-1.4|25.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||25.8|-1.4|0.0737
73993084|NCT04092452|147533295|SUPERIORITY||Risk Difference (RD)|6.6|STANDARD_ERROR_OF_MEAN|8.11||0.2081|TWO_SIDED|90.0|-6.7|20.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||20.0|-6.7|0.2081
74039708|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.87|||<|0.0001|TWO_SIDED|95.0|1.41|2.47|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.47|1.41|<.0001
73876619|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
73993085|NCT04092452|147533295|SUPERIORITY||Risk Difference (RD)|4.8|STANDARD_ERROR_OF_MEAN|8.9||0.2957|TWO_SIDED|90.0|-9.9|19.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||19.4|-9.9|0.2957
73993086|NCT04092452|147533295|SUPERIORITY||Risk Difference (RD)|15.6|STANDARD_ERROR_OF_MEAN|9.07||0.0456|TWO_SIDED|90.0|0.7|30.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||30.5|0.7|0.0456
73993087|NCT04092452|147533295|SUPERIORITY||Risk Difference (RD)|9.2|STANDARD_ERROR_OF_MEAN|9.05||0.1558|TWO_SIDED|90.0|-5.7|24.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||24.1|-5.7|0.1558
73993088|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-11.98|STANDARD_ERROR_OF_MEAN|8.622|||TWO_SIDED|90.0|-26.16|2.2||||||Week 1||2.20|-26.16|
73993089|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-15.07|STANDARD_ERROR_OF_MEAN|8.526|||TWO_SIDED|90.0|-29.09|-1.04||||||Week 1||-1.04|-29.09|
73993090|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-17.45|STANDARD_ERROR_OF_MEAN|8.758|||TWO_SIDED|90.0|-31.86|-3.05||||||Week 1||-3.05|-31.86|
73993091|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-12.52|STANDARD_ERROR_OF_MEAN|9.465|||TWO_SIDED|90.0|-28.09|3.05||||||Week 2||3.05|-28.09|
73993092|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-2.86|STANDARD_ERROR_OF_MEAN|9.338|||TWO_SIDED|90.0|-18.22|12.5||||||Week 2||12.50|-18.22|
73993093|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-5.5|STANDARD_ERROR_OF_MEAN|9.438|||TWO_SIDED|90.0|-21.02|10.03||||||Week 2||10.03|-21.02|
74035592|NCT04047121|147623956|SUPERIORITY||Hazard Ratio (HR)|0.8402||||0.3212|TWO_SIDED|95.0|0.5957|1.1852|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.1852|0.5957|0.3212
73876620|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||4.6|-14.6|1.000
73993094|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-4.52|STANDARD_ERROR_OF_MEAN|11.214|||TWO_SIDED|90.0|-22.96|13.93||||||Week 4||13.93|-22.96|
73993095|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-17.54|STANDARD_ERROR_OF_MEAN|11.131|||TWO_SIDED|90.0|-35.84|0.77||||||Week 4||0.77|-35.84|
73876621|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||13.0|-13.4|1.000
73993096|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-3.92|STANDARD_ERROR_OF_MEAN|11.507|||TWO_SIDED|90.0|-22.85|15.0||||||Week 4||15.00|-22.85|
73993097|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|7.09|STANDARD_ERROR_OF_MEAN|13.452|||TWO_SIDED|90.0|-15.04|29.22||||||Week 6||29.22|-15.04|
73993098|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-14.57|STANDARD_ERROR_OF_MEAN|13.688|||TWO_SIDED|90.0|-37.08|7.95||||||Week 6||7.95|-37.08|
73993099|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-8.95|STANDARD_ERROR_OF_MEAN|13.808|||TWO_SIDED|90.0|-31.66|13.76||||||Week 6||13.76|-31.66|
73993100|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|11.5|STANDARD_ERROR_OF_MEAN|13.057||0.8108|TWO_SIDED|90.0|-9.98|32.98||One-sided p-value|ANCOVA|||Week 8||32.98|-9.98|0.8108
74035593|NCT04047121|147623957|SUPERIORITY|||||||0.9361|||||||Chi-squared|||||||0.9361
73993101|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-16.15|STANDARD_ERROR_OF_MEAN|12.845||0.1043|TWO_SIDED|90.0|-37.28|4.98||One-sided p-value|ANCOVA|||Week 8||4.98|-37.28|0.1043
73993102|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-15.07|STANDARD_ERROR_OF_MEAN|13.355||0.1296|TWO_SIDED|90.0|-37.04|6.9||One-sided p-value|ANCOVA|||Week 8||6.90|-37.04|0.1296
73993103|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-6.54|STANDARD_ERROR_OF_MEAN|16.384||0.345|TWO_SIDED|90.0|-33.49|20.42||One-sided p-value|ANCOVA|||Week 12||20.42|-33.49|0.3450
73993104|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-17.18|STANDARD_ERROR_OF_MEAN|14.116||0.1119|TWO_SIDED|90.0|-40.4|6.04||One-sided p-value|ANCOVA|||Week 12||6.04|-40.40|0.1119
73993105|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-19.99|STANDARD_ERROR_OF_MEAN|14.806||0.0885|TWO_SIDED|90.0|-44.34|4.37||One-sided p-value|ANCOVA|||Week 12||4.37|-44.34|0.0885
73993106|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|10.85|STANDARD_ERROR_OF_MEAN|20.14||0.705|TWO_SIDED|90.0|-22.28|43.98||One-sided p-value|ANCOVA|||Week 16||43.98|-22.28|0.7050
74035594|NCT04047121|147623957|SUPERIORITY|||||||0.3851|||||||Chi-squared|||||||0.3851
74035595|NCT04047121|147623957|SUPERIORITY|||||||0.599|||||||Chi-squared|||||||0.5990
74035596|NCT04047121|147623957|SUPERIORITY||Odds Ratio (OR)|0.9954||||0.986|TWO_SIDED|95.0|0.5962|1.662|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6620|0.5962|0.9860
74035597|NCT04047121|147623957|SUPERIORITY||Odds Ratio (OR)|1.2959||||0.5813|TWO_SIDED|95.0|0.5158|3.2558|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.2558|0.5158|0.5813
73993107|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-17.62|STANDARD_ERROR_OF_MEAN|19.519||0.1833|TWO_SIDED|90.0|-49.73|14.48||One-sided p-value|ANCOVA|||Week 16||14.48|-49.73|0.1833
73993108|NCT04092452|147533296|SUPERIORITY||Risk Difference (RD)|-9.41|STANDARD_ERROR_OF_MEAN|20.277||0.3213|TWO_SIDED|90.0|-42.76|23.94||One-sided p-value|ANCOVA|||Week 16||23.94|-42.76|0.3213
73993109|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|90.0|-5.9|2.9||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.9|-5.9|
73993110|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|90.0|-6.3|2.2||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.2|-6.3|
73993111|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|90.0|-5.9|2.9||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.9|-5.9|
73993112|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|2.59|||TWO_SIDED|90.0|-5.2|3.3||||||Week 2 - Statistical Analysis (MI) - Absolute Score||3.3|-5.2|
73993113|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|90.0|-4.3|4.1||||||Week 2 - Statistical Analysis (MI) - Absolute Score||4.1|-4.3|
73993114|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|90.0|-4.3|4.3||||||Week 2 - Statistical Analysis (MI) - Absolute Score||4.3|-4.3|
73993115|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|90.0|-4.5|3.8||||||Week 4 - Statistical Analysis (MI) - Absolute Score||3.8|-4.5|
73993116|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|90.0|-5.4|2.8||||||Week 4 - Statistical Analysis (MI) - Absolute Score||2.8|-5.4|
73993117|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-4.5|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|90.0|-8.8|-0.3||||||Week 4 - Statistical Analysis (MI) - Absolute Score||-0.3|-8.8|
74035598|NCT04047121|147623957|SUPERIORITY||Odds Ratio (OR)|1.8182||||0.1789|TWO_SIDED|95.0|0.7604|4.3473|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.3473|0.7604|0.1789
73993118|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-1.6|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|90.0|-6.5|3.3||||||Week 6 - Statistical Analysis (MI) - Absolute Score||3.3|-6.5|
73993119|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-4.7|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|90.0|-9.5|0.1||||||Week 6 - Statistical Analysis (MI) - Absolute Score||0.1|-9.5|
73993120|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-5.4|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|90.0|-10.5|-0.4||||||Week 6 - Statistical Analysis (MI) - Absolute Score||-0.4|-10.5|
73993121|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|1.0|STANDARD_ERROR_OF_MEAN|2.78||0.6393|TWO_SIDED|90.0|-3.6|5.6||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||5.6|-3.6|0.6393
73993122|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|2.72||0.5178|TWO_SIDED|90.0|-4.4|4.6||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||4.6|-4.4|0.5178
73993123|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-3.8|STANDARD_ERROR_OF_MEAN|2.82||0.0864|TWO_SIDED|90.0|-8.5|0.8||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||0.8|-8.5|0.0864
73993124|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|2.61||0.3172|TWO_SIDED|90.0|-5.5|3.1||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||3.1|-5.5|0.3172
73993125|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-2.7|STANDARD_ERROR_OF_MEAN|2.51||0.1384|TWO_SIDED|90.0|-6.8|1.4||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||1.4|-6.8|0.1384
74090064|NCT00380692|147733322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.63||0.014||95.0|-2.8|-0.3||P-value for treatment differences in Stereotypic score at 8 weeks.|ANCOVA|||||-0.3|-2.8|0.014
74090065|NCT00380692|147733322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|1.68||0.01||95.0|-7.8|-1.1||P-value for treatment differences in Hyperactivity score at 8 weeks.|ANCOVA|||||-1.1|-7.8|0.010
74090066|NCT00380692|147733322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.42||0.045||95.0|-1.7|0.0||P-value for treatment differences in Inappropriate speech score at 8 weeks.|ANCOVA|||||-0.0|-1.7|0.045
73993126|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-2.8|STANDARD_ERROR_OF_MEAN|2.66||0.1427|TWO_SIDED|90.0|-7.2|1.5||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||1.5|-7.2|0.1427
73993127|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-2.5|STANDARD_ERROR_OF_MEAN|2.99||0.1975|TWO_SIDED|90.0|-7.5|2.4||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||2.4|-7.5|0.1975
74090067|NCT00380692|147733323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|2.13||0.069||95.0|-8.1|0.3||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||0.3|-8.1|0.069
74090068|NCT00380692|147733324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.64||0.598||95.0|-1.6|0.9||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||0.9|-1.6|0.598
74090069|NCT00380692|147733325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|STANDARD_ERROR_OF_MEAN|11.12||0.318||95.0|-33.3|11.0||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||11.0|-33.3|0.318
73993128|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|2.76||0.0755|TWO_SIDED|90.0|-8.5|0.6||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||0.6|-8.5|0.0755
74035599|NCT04047121|147623958|SUPERIORITY|||||||0.4009|||||||Chi-squared|||||||0.4009
74035600|NCT04047121|147623958|SUPERIORITY|||||||0.9765|||||||Chi-squared|||||||0.9765
74035601|NCT04047121|147623958|SUPERIORITY|||||||0.2849|||||||Chi-squared|||||||0.2849
74035602|NCT04047121|147623958|SUPERIORITY||Odds Ratio (OR)|0.8252||||0.5289|TWO_SIDED|95.0|0.4538|1.5007|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.5007|0.4538|0.5289
73993129|NCT04092452|147533297|SUPERIORITY||Risk Difference (RD)|-2.6|STANDARD_ERROR_OF_MEAN|2.89||0.1869|TWO_SIDED|90.0|-7.3|2.2||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||2.2|-7.3|0.1869
73993130|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-3.65|STANDARD_ERROR_OF_MEAN|8.659|||TWO_SIDED|90.0|-17.9|10.59||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||10.59|-17.90|
73993131|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-13.77|STANDARD_ERROR_OF_MEAN|8.749|||TWO_SIDED|90.0|-28.16|0.62||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||0.62|-28.16|
73993132|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-17.51|STANDARD_ERROR_OF_MEAN|8.752|||TWO_SIDED|90.0|-31.91|-3.12||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||-3.12|-31.91|
73993133|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-4.29|STANDARD_ERROR_OF_MEAN|10.103|||TWO_SIDED|90.0|-20.91|12.33||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||12.33|-20.91|
73993134|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-2.05|STANDARD_ERROR_OF_MEAN|9.904|||TWO_SIDED|90.0|-18.34|14.24||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||14.24|-18.34|
73993135|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|10.039|||TWO_SIDED|90.0|-16.34|16.68||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||16.68|-16.34|
73993136|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|10.227|||TWO_SIDED|90.0|-17.29|16.36||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||16.36|-17.29|
73993137|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-8.07|STANDARD_ERROR_OF_MEAN|10.155|||TWO_SIDED|90.0|-24.77|8.63||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||8.63|-24.77|
73993138|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-6.06|STANDARD_ERROR_OF_MEAN|10.509|||TWO_SIDED|90.0|-23.35|11.22||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||11.22|-23.35|
73993139|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-3.54|STANDARD_ERROR_OF_MEAN|12.262|||TWO_SIDED|90.0|-23.71|16.63||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||16.63|-23.71|
73993140|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-16.26|STANDARD_ERROR_OF_MEAN|12.51|||TWO_SIDED|90.0|-36.84|4.32||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||4.32|-36.84|
73993141|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-12.52|STANDARD_ERROR_OF_MEAN|12.61|||TWO_SIDED|90.0|-33.27|8.22||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||8.22|-33.27|
73993142|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|5.79|STANDARD_ERROR_OF_MEAN|11.045||0.7|TWO_SIDED|90.0|-12.38|23.96||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||23.96|-12.38|0.7000
73993143|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-5.81|STANDARD_ERROR_OF_MEAN|10.876||0.2965|TWO_SIDED|90.0|-23.7|12.08||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||12.08|-23.70|0.2965
74090070|NCT00380692|147733326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.7||0.948||95.0|-5.5|5.2||P-value for treatment differences in Error Rate over time.|Mixed Models Analysis|||||5.2|-5.5|0.948
73993144|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-11.33|STANDARD_ERROR_OF_MEAN|11.247||0.1568|TWO_SIDED|90.0|-29.83|7.17||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||7.17|-29.83|0.1568
73993145|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-6.78|STANDARD_ERROR_OF_MEAN|10.912||0.2672|TWO_SIDED|90.0|-24.73|11.17||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||11.17|-24.73|0.2672
73993146|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-16.57|STANDARD_ERROR_OF_MEAN|10.517||0.0576|TWO_SIDED|90.0|-33.87|0.73||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||0.73|-33.87|0.0576
73993147|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-13.65|STANDARD_ERROR_OF_MEAN|11.603||0.1197|TWO_SIDED|90.0|-32.74|5.44||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||5.44|-32.74|0.1197
73993148|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-5.63|STANDARD_ERROR_OF_MEAN|13.545||0.3388|TWO_SIDED|90.0|-27.91|16.65||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Percent Change from Baseline||16.65|-27.91|0.3388
73993149|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-14.8|STANDARD_ERROR_OF_MEAN|13.567||0.1376|TWO_SIDED|90.0|-37.12|7.51||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Percent Change from Baseline||7.51|-37.12|0.1376
73993150|NCT04092452|147533298|SUPERIORITY||Risk Difference (RD)|-8.32|STANDARD_ERROR_OF_MEAN|13.86||0.2741|TWO_SIDED|90.0|-31.12|14.48||One-sided p-value|ANCOVA|||Week 16||14.48|-31.12|0.2741
73993151|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|7.06|||TWO_SIDED|90.0|-13.0|10.3||||||Week 4||10.3|-13.0|
73993152|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|-8.5|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|90.0|-18.7|1.8||||||Week 4||1.8|-18.7|
73993153|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|7.55|||TWO_SIDED|90.0|-10.7|14.1||||||Week 4||14.1|-10.7|
73993154|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|6.6|STANDARD_ERROR_OF_MEAN|6.8||0.8372|TWO_SIDED|90.0|-4.6|17.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||17.7|-4.6|0.8372
74090071|NCT00380692|147733326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|3.5||0.399||95.0|-9.7|3.9||P-value for Treatment\*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis|||||3.9|-9.7|0.399
74090072|NCT00380692|147733326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_DEVIATION|3.1||0.57||95.0|-4.3|7.8||P-value for Treatment\*Condition Error Rate relevant nontargets over time.|Mixed Models Analysis|||||7.8|-4.3|0.570
74090073|NCT00380692|147733327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.9|STANDARD_ERROR_OF_MEAN|66.0||0.352||95.0|-193.5|69.8||P-value for Treatment differences in Reaction time over time.|Mixed Models Analysis|||||69.8|-193.5|0.352
74090074|NCT00380692|147733327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.1|STANDARD_ERROR_OF_MEAN|62.3||0.553||95.0|-160.3|86.2||P-value for Treatment\*Condition Mean Reaction Time correct rejections irrelevant target over time.|Mixed Models Analysis|||||86.2|-160.3|0.553
74090075|NCT00380692|147733327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_ERROR_OF_MEAN|57.7||0.904||95.0|-107.1|121.1||P-value for Treatment\*Condition Mean Reaction Time correct rejections relevant nontarget over time.|Mixed Models Analysis|||||121.1|-107.1|0.904
73993155|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|-6.4|STANDARD_ERROR_OF_MEAN|4.68||0.0819|TWO_SIDED|90.0|-14.1|1.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||1.3|-14.1|0.0819
73993156|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|-8.0|STANDARD_ERROR_OF_MEAN|4.34||0.0242|TWO_SIDED|90.0|-15.2|-0.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||-0.9|-15.2|0.0242
73993157|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|-12.7|STANDARD_ERROR_OF_MEAN|6.33||0.0264|TWO_SIDED|90.0|-23.1|-2.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-2.3|-23.1|0.0264
73993158|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|-14.5|STANDARD_ERROR_OF_MEAN|6.47||0.0127|TWO_SIDED|90.0|-25.1|-3.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-3.9|-25.1|0.0127
73993159|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|-16.6|STANDARD_ERROR_OF_MEAN|6.33||0.0059|TWO_SIDED|90.0|-27.0|-6.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-6.2|-27.0|0.0059
73993160|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|-9.6|STANDARD_ERROR_OF_MEAN|7.97||0.1185|TWO_SIDED|90.0|-22.7|3.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||3.5|-22.7|0.1185
73993161|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|-16.1|STANDARD_ERROR_OF_MEAN|6.39||0.004|TWO_SIDED|90.0|-26.6|-5.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||-5.6|-26.6|0.0040
73993162|NCT04092452|147533299|SUPERIORITY||Risk Difference (RD)|-12.8|STANDARD_ERROR_OF_MEAN|7.09||0.0418|TWO_SIDED|90.0|-24.5|-1.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||-1.1|-24.5|0.0418
73993163|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|12.1|STANDARD_ERROR_OF_MEAN|7.75||0.0559|TWO_SIDED|90.0|-0.7|24.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||24.8|-0.7|0.0559
73993164|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|9.8|STANDARD_ERROR_OF_MEAN|7.09||0.0758|TWO_SIDED|90.0|-1.9|21.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||21.4|-1.9|0.0758
73993165|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|11.3|STANDARD_ERROR_OF_MEAN|7.21||0.0637|TWO_SIDED|90.0|-0.6|23.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||23.2|-0.6|0.0637
73993166|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|4.2|STANDARD_ERROR_OF_MEAN|8.84||0.3179|TWO_SIDED|90.0|-10.3|18.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||18.8|-10.3|0.3179
73993167|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|11.0|STANDARD_ERROR_OF_MEAN|8.82||0.1078|TWO_SIDED|90.0|-3.5|25.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||25.5|-3.5|0.1078
73993168|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|8.86||0.1976|TWO_SIDED|90.0|-7.0|22.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||22.2|-7.0|0.1976
73993169|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|-18.9|STANDARD_ERROR_OF_MEAN|9.32||0.9738|TWO_SIDED|90.0|-34.3|-3.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||-3.6|-34.3|0.9738
73993170|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|10.4||0.2925|TWO_SIDED|90.0|-11.3|22.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||22.9|-11.3|0.2925
73993171|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|-3.1|STANDARD_ERROR_OF_MEAN|10.18||0.6178|TWO_SIDED|90.0|-19.8|13.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||13.7|-19.8|0.6178
73993172|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|-20.9|STANDARD_ERROR_OF_MEAN|10.04||0.9769|TWO_SIDED|90.0|-37.4|-4.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||-4.4|-37.4|0.9769
74090076|NCT00380692|147733328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|65.9||0.748||95.0|-152.8|110.3||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis|||||110.3|-152.8|0.748
74090077|NCT00380692|147733328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-80.9|STANDARD_ERROR_OF_MEAN|77.5||0.299||95.0|-234.3|72.5||P-value for Treatment\*Condition Standard Deviation correct rejections irrelevant target over time.|Mixed Models Analysis|||||72.5|-234.3|0.299
74090078|NCT00380692|147733328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.6|STANDARD_ERROR_OF_MEAN|67.1||0.84||95.0|-119.3|146.5||P-value for Treatment\*Condition Standard Deviation correct rejections relevant nontarget over time.|Mixed Models Analysis|||||146.5|-119.3|0.840
74090079|NCT00380692|147733329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3|STANDARD_ERROR_OF_MEAN|2.8||0.126||95.0|-1.2|9.9||P-value for Treatment differences in Error Rate over time.|Mixed Models Analysis|||||9.9|-1.2|0.126
73876622|NCT02365649|147294840|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||4.6|-14.6|1.000
73993173|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|-4.2|STANDARD_ERROR_OF_MEAN|10.57||0.6529|TWO_SIDED|90.0|-21.6|13.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||13.2|-21.6|0.6529
73993174|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|-12.8|STANDARD_ERROR_OF_MEAN|10.36||0.8878|TWO_SIDED|90.0|-29.8|4.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||4.3|-29.8|0.8878
73993175|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|-6.2|STANDARD_ERROR_OF_MEAN|10.11||0.7259|TWO_SIDED|90.0|-22.9|10.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||10.4|-22.9|0.7259
73993176|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|14.8|STANDARD_ERROR_OF_MEAN|10.24||0.0826|TWO_SIDED|90.0|-2.1|31.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||31.6|-2.1|0.0826
73993177|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|-8.0|STANDARD_ERROR_OF_MEAN|9.75||0.7884|TWO_SIDED|90.0|-24.1|8.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||8.0|-24.1|0.7884
73993178|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|-16.1|STANDARD_ERROR_OF_MEAN|10.43||0.9326|TWO_SIDED|90.0|-33.2|1.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||1.1|-33.2|0.9326
73993179|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|-4.9|STANDARD_ERROR_OF_MEAN|10.41||0.681|TWO_SIDED|90.0|-22.1|12.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||12.2|-22.1|0.6810
73993180|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|-10.3|STANDARD_ERROR_OF_MEAN|10.52||0.8308|TWO_SIDED|90.0|-27.6|7.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||7.0|-27.6|0.8308
73993181|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|-8.5|STANDARD_ERROR_OF_MEAN|9.71||0.8063|TWO_SIDED|90.0|-24.5|7.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||7.4|-24.5|0.8063
73993182|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|6.5|STANDARD_ERROR_OF_MEAN|10.27||0.2649|TWO_SIDED|90.0|-10.4|23.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||23.4|-10.4|0.2649
73993183|NCT04092452|147533300|SUPERIORITY||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|10.35||0.3029|TWO_SIDED|90.0|-11.7|22.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||22.4|-11.7|0.3029
73993184|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|7.7|STANDARD_ERROR_OF_MEAN|8.2||0.1687|TWO_SIDED|90.0|-5.7|21.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||21.2|-5.7|0.1687
73993185|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|13.8|STANDARD_ERROR_OF_MEAN|8.03||0.0376|TWO_SIDED|90.0|0.6|27.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||27.0|0.6|0.0376
73993186|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|6.9||0.5883|TWO_SIDED|90.0|-12.9|9.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||9.8|-12.9|0.5883
73993187|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|2.7|STANDARD_ERROR_OF_MEAN|9.07||0.3829|TWO_SIDED|90.0|-12.2|17.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||17.6|-12.2|0.3829
73993188|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|18.2|STANDARD_ERROR_OF_MEAN|9.54||0.0316|TWO_SIDED|90.0|2.5|33.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||33.9|2.5|0.0316
73993189|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|4.6|STANDARD_ERROR_OF_MEAN|9.17||0.3072|TWO_SIDED|90.0|-10.5|19.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||19.7|-10.5|0.3072
73993190|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|-13.1|STANDARD_ERROR_OF_MEAN|10.18||0.8952|TWO_SIDED|90.0|-29.8|3.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||3.7|-29.8|0.8952
73993191|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|13.1|STANDARD_ERROR_OF_MEAN|10.76||0.1157|TWO_SIDED|90.0|-4.6|30.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||30.8|-4.6|0.1157
73876623|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||45.5|-72.2|1.000
73876624|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||33.1|-50.2|1.000
73993192|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|10.93||0.4672|TWO_SIDED|90.0|-17.1|18.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||18.9|-17.1|0.4672
73876625|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|20.0||||1|TWO_SIDED|95.0|-4.8|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||44.8|-4.8|1.000
73876626|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-23.3||||0.423|TWO_SIDED|95.0|-79.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||33.2|-79.8|0.423
73993193|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|-16.9|STANDARD_ERROR_OF_MEAN|11.29||0.9287|TWO_SIDED|90.0|-35.5|1.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||1.6|-35.5|0.9287
73993194|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|10.85||0.4984|TWO_SIDED|90.0|-17.8|17.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||17.9|-17.8|0.4984
73993195|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|-14.7|STANDARD_ERROR_OF_MEAN|11.27||0.9001|TWO_SIDED|90.0|-33.2|3.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||3.9|-33.2|0.9001
73993196|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|-10.3|STANDARD_ERROR_OF_MEAN|10.53||0.8319|TWO_SIDED|90.0|-27.6|7.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||7.0|-27.6|0.8319
73993197|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|19.7|STANDARD_ERROR_OF_MEAN|10.55||0.034|TWO_SIDED|90.0|2.3|37.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||37.0|2.3|0.0340
73993198|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|-6.8|STANDARD_ERROR_OF_MEAN|10.7||0.7359|TWO_SIDED|90.0|-24.4|10.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||10.8|-24.4|0.7359
73993199|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|-16.0|STANDARD_ERROR_OF_MEAN|10.51||0.9291|TWO_SIDED|90.0|-33.3|1.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||1.3|-33.3|0.9291
73993200|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|10.44||0.5087|TWO_SIDED|90.0|-17.4|16.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||16.9|-17.4|0.5087
73993201|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|-9.5|STANDARD_ERROR_OF_MEAN|10.74||0.8098|TWO_SIDED|90.0|-27.2|8.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||8.1|-27.2|0.8098
73993202|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|-8.8|STANDARD_ERROR_OF_MEAN|9.76||0.8114|TWO_SIDED|90.0|-24.8|7.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||7.2|-24.8|0.8114
73993203|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|10.8|STANDARD_ERROR_OF_MEAN|10.44||0.1531|TWO_SIDED|90.0|-6.4|28.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||28.0|-6.4|0.1531
73993204|NCT04092452|147533301|SUPERIORITY||Risk Difference (RD)|3.3|STANDARD_ERROR_OF_MEAN|10.58||0.3784|TWO_SIDED|90.0|-14.1|20.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||20.7|-14.1|0.3784
73993205|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-7.44|STANDARD_ERROR_OF_MEAN|6.661||0.1321|TWO_SIDED|90.0|-18.39|3.52||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||3.52|-18.39|0.1321
73993206|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-10.52|STANDARD_ERROR_OF_MEAN|6.308||0.0477|TWO_SIDED|90.0|-20.9|-0.14||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||-0.14|-20.90|0.0477
73993207|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-14.13|STANDARD_ERROR_OF_MEAN|6.379||0.0134|TWO_SIDED|90.0|-24.62|-3.63||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||-3.63|-24.62|0.0134
74035603|NCT04047121|147623958|SUPERIORITY||Odds Ratio (OR)|0.9408||||0.927|TWO_SIDED|95.0|0.2553|3.4678|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.4678|0.2553|0.9270
74035604|NCT04047121|147623958|SUPERIORITY||Odds Ratio (OR)|0.3968||||0.0707|TWO_SIDED|95.0|0.1456|1.0812|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0812|0.1456|0.0707
74035605|NCT04047121|147623959|SUPERIORITY|||||||0.2061|||||||Chi-squared|||||||0.2061
74035606|NCT04047121|147623959|SUPERIORITY|||||||0.1908|||||||Chi-squared|||||||0.1908
73993208|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-5.66|STANDARD_ERROR_OF_MEAN|8.38||0.2496|TWO_SIDED|90.0|-19.45|8.12||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||8.12|-19.45|0.2496
73993209|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-11.92|STANDARD_ERROR_OF_MEAN|7.972||0.0675|TWO_SIDED|90.0|-25.03|1.2||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||1.20|-25.03|0.0675
74035607|NCT04047121|147623960|SUPERIORITY|||||||0.8033|||||||Chi-squared|||||||0.8033
73993210|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-11.71|STANDARD_ERROR_OF_MEAN|8.054||0.073|TWO_SIDED|90.0|-24.96|1.54||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||1.54|-24.96|0.0730
74035608|NCT04047121|147623960|SUPERIORITY|||||||0.6669|||||||Chi-squared|||||||0.6669
74035609|NCT04047121|147623960|SUPERIORITY|||||||0.6477|||||||Chi-squared|||||||0.6477
73993211|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|3.25|STANDARD_ERROR_OF_MEAN|8.892||0.6426|TWO_SIDED|90.0|-11.38|17.88||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||17.88|-11.38|0.6426
73993212|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-7.82|STANDARD_ERROR_OF_MEAN|8.457||0.1776|TWO_SIDED|90.0|-21.73|6.09||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||6.09|-21.73|0.1776
74035610|NCT04047121|147623960|SUPERIORITY||Odds Ratio (OR)|0.7948||||0.5509|TWO_SIDED|95.0|0.3736|1.6907|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6907|0.3736|0.5509
74035611|NCT04047121|147623960|SUPERIORITY||Odds Ratio (OR)|0.6814||||0.6216|TWO_SIDED|95.0|0.1486|3.125|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.1250|0.1486|0.6216
74035612|NCT04047121|147623960|SUPERIORITY||Odds Ratio (OR)|0.6974||||0.5506|TWO_SIDED|95.0|0.2135|2.2781|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2781|0.2135|0.5506
74035613|NCT04047121|147623961|SUPERIORITY|||||||0.103|||||||Chi-squared|||||||0.1030
74035614|NCT04047121|147623961|SUPERIORITY|||||||0.9317|||||||Chi-squared|||||||0.9317
74035615|NCT04047121|147623961|SUPERIORITY|||||||0.242|||||||Chi-squared|||||||0.2420
74035616|NCT04047121|147623961|SUPERIORITY||Odds Ratio (OR)|1.7474||||0.0869|TWO_SIDED|95.0|0.9222|3.3107|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.3107|0.9222|0.0869
74035617|NCT04047121|147623961|SUPERIORITY||Odds Ratio (OR)|1.1346||||0.8228|TWO_SIDED|95.0|0.3757|3.4266|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.4266|0.3757|0.8228
74035618|NCT04047121|147623961|SUPERIORITY||Odds Ratio (OR)|1.565||||0.4855|TWO_SIDED|95.0|0.4446|5.5086|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.5086|0.4446|0.4855
74035619|NCT04047121|147623963|SUPERIORITY|||||||0.5092|||||||Chi-squared|||||||0.5092
74035620|NCT04047121|147623963|SUPERIORITY|||||||0.0201|||||||Chi-squared|||||||0.0201
74035621|NCT04047121|147623963|SUPERIORITY|||||||0.2799|||||||Chi-squared|||||||0.2799
74035622|NCT04047121|147623963|SUPERIORITY||Odds Ratio (OR)|0.9021||||0.5772|TWO_SIDED|95.0|0.6281|1.2958|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2958|0.6281|0.5772
74035623|NCT04047121|147623963|SUPERIORITY||Odds Ratio (OR)|1.3953||||0.3272|TWO_SIDED|95.0|0.7166|2.7169|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.7169|0.7166|0.3272
74035624|NCT04047121|147623963|SUPERIORITY||Odds Ratio (OR)|1.3527||||0.3011|TWO_SIDED|95.0|0.763|2.3983|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3983|0.7630|0.3011
74035625|NCT04047121|147623964|SUPERIORITY|||||||0.2931|||||||Chi-squared|||||||0.2931
74035626|NCT04047121|147623964|SUPERIORITY|||||||0.3135|||||||Chi-squared|||||||0.3135
74035627|NCT04047121|147623964|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74090080|NCT00380692|147733329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.7||0.297||95.0|-5.2|1.6||P-value for Treatment\*Error Rate absent over time.|Mixed Models Analysis|||||1.6|-5.2|0.297
74090081|NCT00380692|147733329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|STANDARD_ERROR_OF_MEAN|2.1||0.023||95.0|-9.4|-0.7||P-value for Treatment\*Targets Load 1 over time.|Mixed Models Analysis|||||-0.7|-9.4|0.023
74090082|NCT00380692|147733330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.2|STANDARD_ERROR_OF_MEAN|71.7||0.228||95.0|-230.4|56.0||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis|||||56.0|-230.4|0.228
74035628|NCT04047121|147623964|SUPERIORITY||Odds Ratio (OR)|0.8369||||0.6772|TWO_SIDED|95.0|0.3618|1.9356|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.9356|0.3618|0.6772
74035629|NCT04047121|147623964|SUPERIORITY||Odds Ratio (OR)|5.253||||0.0013|TWO_SIDED|95.0|1.9061|14.477|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||14.4770|1.9061|0.0013
74035630|NCT04047121|147623965|SUPERIORITY|||||||0.5217|||||||Chi-squared|||||||0.5217
74035631|NCT04047121|147623965|SUPERIORITY|||||||0.0432|||||||Chi-squared|||||||0.0432
74035632|NCT04047121|147623965|SUPERIORITY|||||||0.2573|||||||Chi-squared|||||||0.2573
74090083|NCT00380692|147733330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.6|STANDARD_ERROR_OF_MEAN|77.3||0.26||95.0|-65.6|240.8||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 1 over time.|Mixed Models Analysis|||||240.8|-65.6|0.260
74035633|NCT04047121|147623965|SUPERIORITY||Odds Ratio (OR)|0.8593||||0.5368|TWO_SIDED|95.0|0.5311|1.3902|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.3902|0.5311|0.5368
74090084|NCT00380692|147733330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|70.4|STANDARD_ERROR_OF_MEAN|59.5||0.239||95.0|-47.3|188.2||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis|||||188.2|-47.3|0.239
74090085|NCT00380692|147733330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.7|STANDARD_ERROR_OF_MEAN|80.1||0.128||95.0|-35.9|281.4||P-value for Treatment\*Condition Mean Reaction Time hits Load 1 over time.|Mixed Models Analysis|||||281.4|-35.9|0.128
74035634|NCT04047121|147623965|SUPERIORITY||Odds Ratio (OR)|1.2892||||0.4685|TWO_SIDED|95.0|0.6488|2.5616|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.5616|0.6488|0.4685
74035635|NCT04047121|147623965|SUPERIORITY||Odds Ratio (OR)|1.3598||||0.3112|TWO_SIDED|95.0|0.7502|2.4648|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.4648|0.7502|0.3112
74035636|NCT04047121|147623966|SUPERIORITY|||||||0.409|||||||Chi-squared|||||||0.4090
74035637|NCT04047121|147623966|SUPERIORITY|||||||0.0249|||||||Chi-squared|||||||0.0249
74035638|NCT04047121|147623966|SUPERIORITY|||||||0.0103|||||||Chi-squared|||||||0.0103
74035639|NCT04047121|147623966|SUPERIORITY||Odds Ratio (OR)|1.1302||||0.5415|TWO_SIDED|95.0|0.763|1.6741|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6741|0.7630|0.5415
74035640|NCT04047121|147623966|SUPERIORITY||Odds Ratio (OR)|2.0118||||0.0596|TWO_SIDED|95.0|0.9722|4.1632|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.1632|0.9722|0.0596
74035641|NCT04047121|147623966|SUPERIORITY||Odds Ratio (OR)|3.4823||||0.0002|TWO_SIDED|95.0|1.793|6.7633|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.7633|1.7930|0.0002
74035642|NCT04047121|147623967|SUPERIORITY|||||||0.2361|||||||Chi-squared|||||||0.2361
74035643|NCT04047121|147623967|SUPERIORITY|||||||0.7474|||||||Chi-squared|||||||0.7474
74035644|NCT04047121|147623967|SUPERIORITY|||||||0.2118|||||||Chi-squared|||||||0.2118
74035645|NCT04047121|147623967|SUPERIORITY||Odds Ratio (OR)|1.3811||||0.1978|TWO_SIDED|95.0|0.8449|2.2576|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2576|0.8449|0.1978
74035646|NCT04047121|147623967|SUPERIORITY||Odds Ratio (OR)|1.0614||||0.8893|TWO_SIDED|95.0|0.4587|2.4559|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.4559|0.4587|0.8893
74035647|NCT04047121|147623967|SUPERIORITY||Odds Ratio (OR)|0.5811||||0.1553|TWO_SIDED|95.0|0.2748|1.2286|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2286|0.2748|0.1553
74035648|NCT04047121|147623968|SUPERIORITY|||||||0.6767|||||||Chi-squared|||||||0.6767
74035649|NCT04047121|147623968|SUPERIORITY|||||||0.1141|||||||Chi-squared|||||||0.1141
74035650|NCT04047121|147623968|SUPERIORITY|||||||0.1497|||||||Chi-squared|||||||0.1497
74090086|NCT00380692|147733331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-175.5|STANDARD_ERROR_OF_MEAN|88.0||0.051||95.0|-351.5|0.5||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis|||||0.5|-351.5|0.051
74090087|NCT00380692|147733331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|218.1|STANDARD_ERROR_OF_MEAN|90.8||0.018||95.0|38.0|398.2||P-value for Treatment\*Condition Standard Deviation correct rejections Load 1 over time.|Mixed Models Analysis|||||398.2|38.0|0.018
73993213|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-1.17|STANDARD_ERROR_OF_MEAN|8.579||0.4458|TWO_SIDED|90.0|-15.28|12.94||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||12.94|-15.28|0.4458
73993214|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|7.94|STANDARD_ERROR_OF_MEAN|9.566||0.7969|TWO_SIDED|90.0|-7.79|23.68||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||23.68|-7.79|0.7969
73993215|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-11.09|STANDARD_ERROR_OF_MEAN|9.12||0.112|TWO_SIDED|90.0|-26.09|3.91||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||3.91|-26.09|0.1120
73993216|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|9.188||0.5021|TWO_SIDED|90.0|-15.06|15.16||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||15.16|-15.06|0.5021
73993217|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|2.83|STANDARD_ERROR_OF_MEAN|9.296||0.6197|TWO_SIDED|90.0|-12.46|18.12||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||18.12|-12.46|0.6197
73993218|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-11.3|STANDARD_ERROR_OF_MEAN|8.825||0.1003|TWO_SIDED|90.0|-25.81|3.22||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||3.22|-25.81|0.1003
73993219|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|8.908||0.507|TWO_SIDED|90.0|-14.5|14.81||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||14.81|-14.50|0.5070
73993220|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|0.67|STANDARD_ERROR_OF_MEAN|9.368||0.5283|TWO_SIDED|90.0|-14.74|16.08||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||16.08|-14.74|0.5283
73993221|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-15.31|STANDARD_ERROR_OF_MEAN|8.921||0.0431|TWO_SIDED|90.0|-29.98|-0.63||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||-0.63|-29.98|0.0431
73993222|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-6.39|STANDARD_ERROR_OF_MEAN|9.02||0.2395|TWO_SIDED|90.0|-21.22|8.45||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||8.45|-21.22|0.2395
73993223|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|2.57|STANDARD_ERROR_OF_MEAN|9.617||0.6054|TWO_SIDED|90.0|-13.25|18.39||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||18.39|-13.25|0.6054
73993224|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-21.54|STANDARD_ERROR_OF_MEAN|9.344||0.0106|TWO_SIDED|90.0|-36.91|-6.17||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||-6.17|-36.91|0.0106
73993225|NCT04092452|147533302|SUPERIORITY||Risk Difference (RD)|-12.54|STANDARD_ERROR_OF_MEAN|9.305||0.089|TWO_SIDED|90.0|-27.84|2.77||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||2.77|-27.84|0.0890
73993226|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-6.17|STANDARD_ERROR_OF_MEAN|5.963||0.1505|TWO_SIDED|90.0|-15.98|3.64||One-sided p-value|ANCOVA|||Week 1 Average Pain||3.64|-15.98|0.1505
73993227|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-11.06|STANDARD_ERROR_OF_MEAN|5.555||0.0233|TWO_SIDED|90.0|-20.19|-1.92||One-sided p-value|ANCOVA|||Week 1 Average Pain||-1.92|-20.19|0.0233
73993228|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-6.34|STANDARD_ERROR_OF_MEAN|5.926||0.1423|TWO_SIDED|90.0|-16.09|3.41||One-sided p-value|ANCOVA|||Week 1 Average Pain||3.41|-16.09|0.1423
73993229|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-2.15|STANDARD_ERROR_OF_MEAN|7.202||0.3827|TWO_SIDED|90.0|-14.0|9.7||One-sided p-value|ANCOVA|||Week 2 Average Pain||9.70|-14.00|0.3827
73993230|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-10.35|STANDARD_ERROR_OF_MEAN|6.741||0.0624|TWO_SIDED|90.0|-21.44|0.74||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.74|-21.44|0.0624
73993231|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-2.25|STANDARD_ERROR_OF_MEAN|7.171||0.3771|TWO_SIDED|90.0|-14.04|9.55||One-sided p-value|ANCOVA|||Week 2 Average Pain||9.55|-14.04|0.3771
73993232|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|8.04|STANDARD_ERROR_OF_MEAN|8.614||0.8247|TWO_SIDED|90.0|-6.13|22.21||One-sided p-value|ANCOVA|||Week 4 Average Pain||22.21|-6.13|0.8247
74090088|NCT00380692|147733331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|173.6|STANDARD_ERROR_OF_MEAN|105.6||0.103||95.0|-35.7|383.0||P-value for Treatment\*Condition Standard Deviation correct rejections Load 2 over time.|Mixed Models Analysis|||||383.0|-35.7|0.103
73993233|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-8.97|STANDARD_ERROR_OF_MEAN|8.09||0.1337|TWO_SIDED|90.0|-22.28|4.33||One-sided p-value|ANCOVA|||Week 4 Average Pain||4.33|-22.28|0.1337
73993234|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|5.37|STANDARD_ERROR_OF_MEAN|8.523||0.7357|TWO_SIDED|90.0|-8.65|19.39||One-sided p-value|ANCOVA|||Week 4 Average Pain||19.39|-8.65|0.7357
73993235|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|13.78|STANDARD_ERROR_OF_MEAN|8.977||0.9377|TWO_SIDED|90.0|-0.98|28.55||One-sided p-value|ANCOVA|||Week 6 Average Pain||28.55|-0.98|0.9377
73993236|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-9.39|STANDARD_ERROR_OF_MEAN|8.45||0.1332|TWO_SIDED|90.0|-23.29|4.51||One-sided p-value|ANCOVA|||Week 6 Average Pain||4.51|-23.29|0.1332
73993237|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|6.05|STANDARD_ERROR_OF_MEAN|8.907||0.7514|TWO_SIDED|90.0|-8.6|20.7||One-sided p-value|ANCOVA|||Week 6 Average Pain||20.70|-8.60|0.7514
73993238|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|8.97|STANDARD_ERROR_OF_MEAN|8.902||0.8433|TWO_SIDED|90.0|-5.67|23.62||One-sided p-value|ANCOVA|||Week 8 Average Pain||23.62|-5.67|0.8433
73993239|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-8.84|STANDARD_ERROR_OF_MEAN|8.392||0.1461|TWO_SIDED|90.0|-22.64|4.96||One-sided p-value|ANCOVA|||Week 8 Average Pain||4.96|-22.64|0.1461
73993240|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|8.64|STANDARD_ERROR_OF_MEAN|8.818||0.8364|TWO_SIDED|90.0|-5.86|23.15||One-sided p-value|ANCOVA|||Week 8 Average Pain||23.15|-5.86|0.8364
73993241|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|2.35|STANDARD_ERROR_OF_MEAN|8.527||0.6085|TWO_SIDED|90.0|-11.68|16.37||One-sided p-value|ANCOVA|||Week 12 Average Pain||16.37|-11.68|0.6085
73993242|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-14.38|STANDARD_ERROR_OF_MEAN|8.022||0.0365|TWO_SIDED|90.0|-27.58|-1.19||One-sided p-value|ANCOVA|||Week 12 Average Pain||-1.19|-27.58|0.0365
73993243|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|8.469||0.5201|TWO_SIDED|90.0|-13.5|14.36||One-sided p-value|ANCOVA|||Week 12 Average Pain||14.36|-13.50|0.5201
73993244|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|4.04|STANDARD_ERROR_OF_MEAN|8.564||0.6813|TWO_SIDED|90.0|-10.05|18.12||One-sided p-value|ANCOVA|||Week 16 Average Pain||18.12|-10.05|0.6813
73993245|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-18.38|STANDARD_ERROR_OF_MEAN|8.23||0.0128|TWO_SIDED|90.0|-31.91|-4.84||One-sided p-value|ANCOVA|||Week 16 Average Pain||-4.84|-31.91|0.0128
73993246|NCT04092452|147533303|SUPERIORITY||Risk Difference (RD)|-4.09|STANDARD_ERROR_OF_MEAN|8.639||0.3181|TWO_SIDED|90.0|-18.3|10.12||One-sided p-value|ANCOVA|||Week 16 Average Pain||10.12|-18.30|0.3181
73993247|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.301||0.1536|TWO_SIDED|90.0|-0.8|0.19||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.19|-0.80|0.1536
73993248|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.289||0.0581|TWO_SIDED|90.0|-0.93|0.02||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.02|-0.93|0.0581
73993249|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.3||0.0532|TWO_SIDED|90.0|-0.98|0.01||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.01|-0.98|0.0532
73993250|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.383||0.2007|TWO_SIDED|90.0|-0.95|0.31||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.31|-0.95|0.2007
73993251|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-0.55|STANDARD_ERROR_OF_MEAN|0.37||0.0694|TWO_SIDED|90.0|-1.16|0.06||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.06|-1.16|0.0694
73993252|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.382||0.1509|TWO_SIDED|90.0|-1.02|0.23||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.23|-1.02|0.1509
73993253|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.431||0.5663|TWO_SIDED|90.0|-0.64|0.78||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.78|-0.64|0.5663
73993254|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.416||0.1396|TWO_SIDED|90.0|-1.13|0.23||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.23|-1.13|0.1396
73993255|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.432||0.5227|TWO_SIDED|90.0|-0.69|0.74||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.74|-0.69|0.5227
73993256|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.45||0.8656|TWO_SIDED|90.0|-0.24|1.24||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||1.24|-0.24|0.8656
73993257|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.434||0.1671|TWO_SIDED|90.0|-1.13|0.29||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||0.29|-1.13|0.1671
73993258|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.45||0.6063|TWO_SIDED|90.0|-0.62|0.86||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||0.86|-0.62|0.6063
73993259|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.458||0.6402|TWO_SIDED|90.0|-0.59|0.92||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.92|-0.59|0.6402
73993260|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-0.38|STANDARD_ERROR_OF_MEAN|0.441||0.1916|TWO_SIDED|90.0|-1.11|0.34||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.34|-1.11|0.1916
73993261|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|0.13|STANDARD_ERROR_OF_MEAN|0.456||0.6119|TWO_SIDED|90.0|-0.62|0.88||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.88|-0.62|0.6119
73993262|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.45||0.5568|TWO_SIDED|90.0|-0.68|0.8||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.80|-0.68|0.5568
73993263|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.433||0.0976|TWO_SIDED|90.0|-1.27|0.15||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.15|-1.27|0.0976
73993264|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.451||0.5001|TWO_SIDED|90.0|-0.74|0.74||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.74|-0.74|0.5001
73993265|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.451||0.581|TWO_SIDED|90.0|-0.65|0.83||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||0.83|-0.65|0.5810
73993266|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-1.07|STANDARD_ERROR_OF_MEAN|0.442||0.0079|TWO_SIDED|90.0|-1.8|-0.34||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||-0.34|-1.80|0.0079
73993267|NCT04092452|147533304|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.455||0.1068|TWO_SIDED|90.0|-1.31|0.18||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||0.18|-1.31|0.1068
73993268|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.284||0.1898|TWO_SIDED|90.0|-0.72|0.22||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.22|-0.72|0.1898
73993269|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.43|STANDARD_ERROR_OF_MEAN|0.273||0.0562|TWO_SIDED|90.0|-0.88|0.02||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.02|-0.88|0.0562
73993270|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.284||0.1382|TWO_SIDED|90.0|-0.78|0.16||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.16|-0.78|0.1382
73993271|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.343||0.2039|TWO_SIDED|90.0|-0.85|0.28||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.28|-0.85|0.2039
73993272|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.332||0.0855|TWO_SIDED|90.0|-1.0|0.09||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.09|-1.00|0.0855
73993273|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.344||0.3089|TWO_SIDED|90.0|-0.74|0.39||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.39|-0.74|0.3089
73993274|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.407||0.6124|TWO_SIDED|90.0|-0.55|0.79||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.79|-0.55|0.6124
73993275|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|0.395||0.1003|TWO_SIDED|90.0|-1.15|0.14||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.14|-1.15|0.1003
73993276|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.408||0.6875|TWO_SIDED|90.0|-0.47|0.87||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.87|-0.47|0.6875
74090089|NCT00380692|147733331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|205.5|STANDARD_ERROR_OF_MEAN|99.9||0.042||95.0|7.5|403.6||P-value for Treatment\*Condition Standard Deviation hits Load 1 over time.|Mixed Models Analysis|||||403.6|7.5|0.042
74090090|NCT00380692|147733332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.3|STANDARD_ERROR_OF_MEAN|4.6||0.128||95.0|-16.9|2.3||P-value for Treatment difference in Accuracy over time.|Mixed Models Analysis|||||2.3|-16.9|0.128
74090091|NCT00380692|147733333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.4||0.022||95.0|-11.2|-1.0||P-value for Treatment difference in Stability of Movement over time.|Mixed Models Analysis|||||-1.0|-11.2|0.022
73993277|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|0.51|STANDARD_ERROR_OF_MEAN|0.427||0.8833|TWO_SIDED|90.0|-0.19|1.21||One-sided p-value|ANCOVA|||Week 6 Average Pain||1.21|-0.19|0.8833
73993278|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.43|STANDARD_ERROR_OF_MEAN|0.413||0.1502|TWO_SIDED|90.0|-1.11|0.25||One-sided p-value|ANCOVA|||Week 6 Average Pain||0.25|-1.11|0.1502
73993279|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.428||0.6788|TWO_SIDED|90.0|-0.5|0.9||One-sided p-value|ANCOVA|||Week 6 Average Pain||0.90|-0.50|0.6788
73993280|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.441||0.6835|TWO_SIDED|90.0|-0.51|0.94||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.94|-0.51|0.6835
73993281|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.425||0.2237|TWO_SIDED|90.0|-1.02|0.38||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.38|-1.02|0.2237
73993282|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.439||0.7234|TWO_SIDED|90.0|-0.46|0.98||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.98|-0.46|0.7234
73993283|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.424||0.4773|TWO_SIDED|90.0|-0.72|0.67||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.67|-0.72|0.4773
74090092|NCT00380692|147733334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|2.0||0.43||95.0|-2.4|5.7||P-value for Treatment difference in Error Rate over time.|Mixed Models Analysis|||||5.7|-2.4|0.430
73993284|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.41||0.0818|TWO_SIDED|90.0|-1.25|0.1||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.10|-1.25|0.0818
73993285|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.424||0.6397|TWO_SIDED|90.0|-0.55|0.85||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.85|-0.55|0.6397
74090093|NCT00380692|147733334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0|STANDARD_ERROR_OF_MEAN|2.4||0.005||95.0|-11.8|-2.2||P-value for Treatment\*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis|||||-2.2|-11.8|0.005
74090094|NCT00380692|147733335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|2.9||0.221||95.0|-9.6|2.3||P-value for Treatment differences in Error Rates over time.|Mixed Models Analysis|||||2.3|-9.6|0.221
74090095|NCT00380692|147733335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|2.0||0.307||95.0|-2.1|6.3||P-value for Treatment\*Condition Error Rates compatible signals over time.|Mixed Models Analysis|||||6.3|-2.1|0.307
73993286|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|0.03|STANDARD_ERROR_OF_MEAN|0.428||0.5321|TWO_SIDED|90.0|-0.67|0.74||One-sided p-value|ANCOVA|||Week 16 Average Pain||0.74|-0.67|0.5321
73993287|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.89|STANDARD_ERROR_OF_MEAN|0.42||0.0167|TWO_SIDED|90.0|-1.59|-0.2||One-sided p-value|ANCOVA|||Week 16 Average Pain||-0.20|-1.59|0.0167
73993288|NCT04092452|147533305|SUPERIORITY||Risk Difference (RD)|-0.37|STANDARD_ERROR_OF_MEAN|0.434||0.1963|TWO_SIDED|90.0|-1.09|0.34||One-sided p-value|ANCOVA|||Week 16 Average Pain||0.34|-1.09|0.1963
73993289|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|90.0|-10.3|6.0||||||Week 1||6.0|-10.3|
73993290|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|2.0|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-7.3|11.3||||||Week 1||11.3|-7.3|
73993291|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|6.8|STANDARD_ERROR_OF_MEAN|6.47|||TWO_SIDED|90.0|-3.9|17.4||||||Week 1||17.4|-3.9|
73993292|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|10.7|STANDARD_ERROR_OF_MEAN|7.74|||TWO_SIDED|90.0|-2.0|23.4||||||Week 2||23.4|-2.0|
73993293|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|7.34|||TWO_SIDED|90.0|-4.5|19.7||||||Week 2||19.7|-4.5|
73993294|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|7.5|STANDARD_ERROR_OF_MEAN|7.36|||TWO_SIDED|90.0|-4.6|19.6||||||Week 2||19.6|-4.6|
73993295|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|7.4|STANDARD_ERROR_OF_MEAN|7.95|||TWO_SIDED|90.0|-5.7|20.5||||||Week 4||20.5|-5.7|
73993296|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|15.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|90.0|1.4|28.7||||||Week 4||28.7|1.4|
73993297|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|4.8|STANDARD_ERROR_OF_MEAN|7.74|||TWO_SIDED|90.0|-8.0|17.5||||||Week 4||17.5|-8.0|
73993298|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|14.3|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|90.0|0.7|28.0||||||Week 6||28.0|0.7|
73993299|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|10.9|STANDARD_ERROR_OF_MEAN|7.96|||TWO_SIDED|90.0|-2.2|24.0||||||Week 6||24.0|-2.2|
73993300|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|10.6|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|90.0|-2.6|23.9||||||Week 6||23.9|-2.6|
73993301|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|10.1|STANDARD_ERROR_OF_MEAN|8.38||0.1162|TWO_SIDED|90.0|-3.6|23.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||23.9|-3.6|0.1162
74090096|NCT00380692|147733336|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.0|STANDARD_ERROR_OF_MEAN|68.9||0.752||95.0|-163.1|119.1||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis|||||119.1|-163.1|0.752
73876627|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-32.9||||0.25|TWO_SIDED|95.0|-74.0|8.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||8.2|-74.0|0.250
73876628|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-8.6|28.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||28.6|-8.6|1.000
73876629|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|20.0||||1|TWO_SIDED|95.0|-4.8|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.8|-4.8|1.000
73993302|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|13.1|STANDARD_ERROR_OF_MEAN|8.43||0.0642|TWO_SIDED|90.0|-0.8|27.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||27.0|-0.8|0.0642
73993303|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|8.1|STANDARD_ERROR_OF_MEAN|8.36||0.1664|TWO_SIDED|90.0|-5.7|21.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||21.8|-5.7|0.1664
73993304|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|7.2|STANDARD_ERROR_OF_MEAN|8.1||0.1882|TWO_SIDED|90.0|-6.1|20.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||20.5|-6.1|0.1882
73993305|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|14.9|STANDARD_ERROR_OF_MEAN|8.43||0.0423|TWO_SIDED|90.0|1.1|28.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||28.8|1.1|0.0423
73993306|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|3.3|STANDARD_ERROR_OF_MEAN|7.9||0.3396|TWO_SIDED|90.0|-9.7|16.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||16.3|-9.7|0.3396
73993307|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|2.7|STANDARD_ERROR_OF_MEAN|7.35||0.3584|TWO_SIDED|90.0|-9.4|14.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||14.8|-9.4|0.3584
73993308|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|14.9|STANDARD_ERROR_OF_MEAN|8.17||0.0367|TWO_SIDED|90.0|1.5|28.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||28.3|1.5|0.0367
73993309|NCT04092452|147533306|SUPERIORITY||Risk Difference (RD)|5.2|STANDARD_ERROR_OF_MEAN|7.65||0.2486|TWO_SIDED|90.0|-7.4|17.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||17.8|-7.4|0.2486
73993310|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.69|0.29||||||Week 1-HSS0101-Pain At It's Worst||0.29|-0.69|
74090097|NCT00380692|147733336|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.6|STANDARD_ERROR_OF_MEAN|31.9||0.564||95.0|-47.0|84.3||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis|||||84.3|-47.0|0.564
73876630|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||33.1|-50.2|1.000
74090098|NCT02177136|147733362|SUPERIORITY|||||||0.0434|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.||||||0.0434
73993311|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|90.0|-0.96|-0.01||||||Week 1-HSS0101-Pain At It's Worst||-0.01|-0.96|
73993312|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.91|0.06||||||Week 1-HSS0101-Pain At It's Worst||0.06|-0.91|
73993313|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|90.0|-0.95|0.35||||||Week 2-HSS0101-Pain At It's Worst||0.35|-0.95|
74090099|NCT02177136|147733362|SUPERIORITY|||||||0.0665|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.||||||0.0665
74090100|NCT02054130|147733393|SUPERIORITY||Rate ratio|0.38|||<|0.001|TWO_SIDED|95.0|0.23|0.63|||Negative binomial regression|||||0.63|0.23|<0.001
73993314|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.71|STANDARD_ERROR_OF_MEAN|0.377|||TWO_SIDED|90.0|-1.33|-0.08||||||Week 2-HSS0101-Pain At It's Worst||-0.08|-1.33|
73993315|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.391|||TWO_SIDED|90.0|-1.21|0.08||||||Week 2-HSS0101-Pain At It's Worst||0.08|-1.21|
73993316|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.481|||TWO_SIDED|90.0|-0.54|1.05||||||Week 4-HSS0101-Pain At It's Worst||1.05|-0.54|
73993317|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|90.0|-1.15|0.37||||||Week 4-HSS0101-Pain At It's Worst||0.37|-1.15|
74090101|NCT02054130|147733393|SUPERIORITY||Rate ratio|0.29|||<|0.001|TWO_SIDED|95.0|0.16|0.51|||Negative binomial regression|||||0.51|0.16|<0.001
74090102|NCT02054130|147733393|SUPERIORITY||Rate ratio|0.34|||<|0.001|TWO_SIDED|95.0|0.2|0.58|||Negative bnomial regression|||||0.58|0.20|<0.001
74090103|NCT00094458|147733451|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||<0.001
73876631|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||45.5|-72.2|1.000
73876632|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-46.7||||0.203|TWO_SIDED|95.0|-100.0|12.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||12.2|-100.0|0.203
73993318|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.478|||TWO_SIDED|90.0|-0.85|0.73||||||Week 4-HSS0101-Pain At It's Worst||0.73|-0.85|
73993319|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.62|STANDARD_ERROR_OF_MEAN|0.524|||TWO_SIDED|90.0|-0.24|1.49||||||Week 6-HSS0101-Pain At It's Worst||1.49|-0.24|
73993320|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.19|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.03|0.64||||||Week 6-HSS0101-Pain At It's Worst||0.64|-1.03|
73993321|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|90.0|-0.66|1.08||||||Week 6-HSS0101-Pain At It's Worst||1.08|-0.66|
73993322|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.558|||TWO_SIDED|90.0|-0.69|1.16||||||Week 8-HSS0101-Pain At It's Worst||1.16|-0.69|
73993323|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.539|||TWO_SIDED|90.0|-1.21|0.57||||||Week 8-HSS0101-Pain At It's Worst||0.57|-1.21|
73993324|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|90.0|-0.49|1.38||||||Week 8-HSS0101-Pain At It's Worst||1.38|-0.49|
73993325|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.578|||TWO_SIDED|90.0|-0.79|1.12||||||Week 12-HSS0101-Pain At It's Worst||1.12|-0.79|
73993326|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-1.59|0.23||||||Week 12-HSS0101-Pain At It's Worst||0.23|-1.59|
73993327|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.576|||TWO_SIDED|90.0|-0.88|1.03||||||Week 12-HSS0101-Pain At It's Worst||1.03|-0.88|
73993328|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.631|||TWO_SIDED|90.0|-0.96|1.13||||||Week 16-HSS0101-Pain At It's Worst||1.13|-0.96|
73993329|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-1.25|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.24|-0.25||||||Week 16-HSS0101-Pain At It's Worst||-0.25|-2.24|
73993330|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.91|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|90.0|-1.95|0.13||||||Week 16-HSS0101-Pain At It's Worst||0.13|-1.95|
73993331|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.47|0.48||||||Week 1-HSS0102-Tenderness At It's Worst||0.48|-0.47|
73993332|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.75|0.18||||||Week 1-HSS0102-Tenderness At It's Worst||0.18|-0.75|
73993333|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.78|0.17||||||Week 1-HSS0102-Tenderness At It's Worst||0.17|-0.78|
73993334|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.22|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|90.0|-0.81|0.38||||||Week 2-HSS0102-Tenderness At It's Worst||0.38|-0.81|
73993335|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.347|||TWO_SIDED|90.0|-0.97|0.18||||||Week 2-HSS0102-Tenderness At It's Worst||0.18|-0.97|
73993336|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.14||||||Week 2-HSS0102-Tenderness At It's Worst||0.14|-1.05|
74090104|NCT00094458|147733451|SUPERIORITY_OR_OTHER|||||||0.006|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.006
74090105|NCT00094458|147733451|SUPERIORITY_OR_OTHER|||||||0.022|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.022
74090106|NCT00094458|147733452|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||<0.001
74090107|NCT00094458|147733452|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.023
74090108|NCT00094458|147733452|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.055
73993337|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.471|||TWO_SIDED|90.0|-0.56|1.0||||||Week 4-HSS0102-Tenderness At It's Worst||1.00|-0.56|
73993338|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|90.0|-0.99|0.49||||||Week 4-HSS0102-Tenderness At It's Worst||0.49|-0.99|
73993339|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.11|STANDARD_ERROR_OF_MEAN|0.468|||TWO_SIDED|90.0|-0.88|0.67||||||Week 4-HSS0102-Tenderness At It's Worst||0.67|-0.88|
73993340|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.48|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|-0.38|1.34||||||Week 6-HSS0102-Tenderness At It's Worst||1.34|-0.38|
73993341|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-1.06|0.6||||||Week 6-HSS0102-Tenderness At It's Worst||0.60|-1.06|
74090109|NCT03265288|147733460|SUPERIORITY||Least square means difference|0.7716||||0.3449|TWO_SIDED|95.0|-0.8397|2.3828||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Primary analysis of the treatment effect at the Week 24 visit on the intent to treat population (ITT) Null hypothesis is no treatment difference||2.3828|-0.8397|0.3449
74090110|NCT03265288|147733460|SUPERIORITY||Least square means difference|1.0053||||0.0667|TWO_SIDED|95.0|-0.07|2.0807||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Analysis of the overall treatment effect from baseline through Week 24 in the intent to treat population (ITT), Null hypothesis is no treatment difference||2.0807|-0.0700|0.0667
73993342|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-0.86|0.87||||||Week 6-HSS0102-Tenderness At It's Worst||0.87|-0.86|
73993343|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.542|||TWO_SIDED|90.0|-0.81|0.99||||||Week 8-HSS0102-Tenderness At It's Worst||0.99|-0.81|
73993344|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.11|0.62||||||Week 8-HSS0102-Tenderness At It's Worst||0.62|-1.11|
73993345|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.549|||TWO_SIDED|90.0|-0.56|1.25||||||Week 8-HSS0102-Tenderness At It's Worst||1.25|-0.56|
73993346|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.554|||TWO_SIDED|90.0|-0.87|0.97||||||Week 12-HSS0102-Tenderness At It's Worst||0.97|-0.87|
73993347|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.49|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.36|0.38||||||Week 12-HSS0102-Tenderness At It's Worst||0.38|-1.36|
73993348|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.552|||TWO_SIDED|90.0|-0.9|0.93||||||Week 12-HSS0102-Tenderness At It's Worst||0.93|-0.90|
73993349|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.606|||TWO_SIDED|90.0|-0.96|1.04||||||Week 16-HSS0102-Tenderness At It's Worst||1.04|-0.96|
73993350|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-1.24|STANDARD_ERROR_OF_MEAN|0.577|||TWO_SIDED|90.0|-2.19|-0.29||||||Week 16-HSS0102-Tenderness At It's Worst||-0.29|-2.19|
73993351|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 16-HSS0102-Tenderness At It's Worst||-0.11|-2.11|
73993352|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.284|||TWO_SIDED|90.0|-0.57|0.37||||||Week 1-HSS0103-Swelling At It's Worst||0.37|-0.57|
73993353|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.69|0.22||||||Week 1-HSS0103-Swelling At It's Worst||0.22|-0.69|
73993354|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.285|||TWO_SIDED|90.0|-0.94|0.01||||||Week 1-HSS0103-Swelling At It's Worst||0.01|-0.94|
73993355|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.24|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.83|0.35||||||Week 2-HSS0103-Swelling At It's Worst||0.35|-0.83|
74035651|NCT04047121|147623968|SUPERIORITY||Odds Ratio (OR)|0.8556||||0.5228|TWO_SIDED|95.0|0.5303|1.3804|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.3804|0.5303|0.5228
74035652|NCT04047121|147623968|SUPERIORITY||Odds Ratio (OR)|2.5125||||0.0277|TWO_SIDED|95.0|1.1062|5.7063|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.7063|1.1062|0.0277
74035653|NCT04047121|147623968|SUPERIORITY||Odds Ratio (OR)|0.6993||||0.324|TWO_SIDED|95.0|0.3435|1.4236|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4236|0.3435|0.3240
73993356|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|90.0|-1.03|0.11||||||Week 2-HSS0103-Swelling At It's Worst||0.11|-1.03|
73993357|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.99|0.19||||||Week 2-HSS0103-Swelling At It's Worst||0.19|-0.99|
73993358|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.446|||TWO_SIDED|90.0|-0.58|0.9||||||Week 4-HSS0103-Swelling At It's Worst||0.90|-0.58|
73993359|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.424|||TWO_SIDED|90.0|-0.87|0.53||||||Week 4-HSS0103-Swelling At It's Worst||0.53|-0.87|
73993360|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|90.0|-0.65|0.82||||||Week 4-HSS0103-Swelling At It's Worst||0.82|-0.65|
73993361|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|90.0|-0.15|1.54||||||Week 6-HSS0103-Swelling At It's Worst||1.54|-0.15|
73993362|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.493|||TWO_SIDED|90.0|-0.83|0.8||||||Week 6-HSS0103-Swelling At It's Worst||0.80|-0.83|
73993363|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.513|||TWO_SIDED|90.0|-0.62|1.08||||||Week 6-HSS0103-Swelling At It's Worst||1.08|-0.62|
73993364|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.29|STANDARD_ERROR_OF_MEAN|0.507|||TWO_SIDED|90.0|-0.55|1.13||||||Week 8-HSS0103-Swelling At It's Worst||1.13|-0.55|
73993365|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-0.81|0.81||||||Week 8-HSS0103-Swelling At It's Worst||0.81|-0.81|
73993366|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.514|||TWO_SIDED|90.0|-0.35|1.35||||||Week 8-HSS0103-Swelling At It's Worst||1.35|-0.35|
74035654|NCT04047121|147623969|SUPERIORITY|||||||0.6318|||||||t-test, 2 sided|||||||0.6318
74035655|NCT04047121|147623969|SUPERIORITY|||||||0.3802|||||||t-test, 2 sided|||||||0.3802
74035656|NCT04047121|147623969|SUPERIORITY|||||||0.2424|||||||t-test, 2 sided|||||||0.2424
74035657|NCT04047121|147623969|SUPERIORITY||Odds Ratio (OR)|0.0347||||0.1753|TWO_SIDED|95.0|-0.0155|0.0848|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0848|-0.0155|0.1753
74035658|NCT04047121|147623969|SUPERIORITY||Odds Ratio (OR)|0.0194||||0.6114|TWO_SIDED|95.0|-0.0553|0.0941|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0941|-0.0553|0.6114
74035659|NCT04047121|147623969|SUPERIORITY||Odds Ratio (OR)|0.0345||||0.2977|TWO_SIDED|95.0|-0.0304|0.0993|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0993|-0.0304|0.2977
73993367|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-0.81|0.95||||||Week 12-HSS0103-Swelling At It's Worst||0.95|-0.81|
73993368|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.3|0.37||||||Week 12-HSS0103-Swelling At It's Worst||0.37|-1.30|
73993369|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.92|0.84||||||Week 12-HSS0103-Swelling At It's Worst||0.84|-0.92|
73993370|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|90.0|-0.75|1.2||||||Week 16-HSS0103-Swelling At It's Worst||1.20|-0.75|
73993371|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-1.06|STANDARD_ERROR_OF_MEAN|0.561|||TWO_SIDED|90.0|-1.99|-0.13||||||Week 16-HSS0103-Swelling At It's Worst||-0.13|-1.99|
73993372|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-1.02|STANDARD_ERROR_OF_MEAN|0.586|||TWO_SIDED|90.0|-1.99|-0.05||||||Week 16-HSS0103-Swelling At It's Worst||-0.05|-1.99|
73993373|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.27|0.59||||||Week 1-HSS0104-Tiredness At It's Worst||0.59|-0.27|
73993374|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|-0.99|-0.15||||||Week 1-HSS0104-Tiredness At It's Worst||-0.15|-0.99|
73993375|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.35|0.52||||||Week 1-HSS0104-Tiredness At It's Worst||0.52|-0.35|
73993376|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.54|0.65||||||Week 2-HSS0104-Tiredness At It's Worst||0.65|-0.54|
73993377|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.44|STANDARD_ERROR_OF_MEAN|0.344|||TWO_SIDED|90.0|-1.01|0.13||||||Week 2-HSS0104-Tiredness At It's Worst||0.13|-1.01|
73993378|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.356|||TWO_SIDED|90.0|-0.33|0.85||||||Week 2-HSS0104-Tiredness At It's Worst||0.85|-0.33|
73993379|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.12|STANDARD_ERROR_OF_MEAN|0.434|||TWO_SIDED|90.0|-0.83|0.6||||||Week 4-HSS0104-Tiredness At It's Worst||0.60|-0.83|
73993380|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.414|||TWO_SIDED|90.0|-1.49|-0.12||||||Week 4-HSS0104-Tiredness At It's Worst||-0.12|-1.49|
73993381|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.14|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|90.0|-0.86|0.57||||||Week 4-HSS0104-Tiredness At It's Worst||0.57|-0.86|
73993382|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.76|0.84||||||Week 6-HSS0104-Tiredness At It's Worst||0.84|-0.76|
73993383|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.52|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.29|0.26||||||Week 6-HSS0104-Tiredness At It's Worst||0.26|-1.29|
73993384|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.485|||TWO_SIDED|90.0|-0.68|0.92||||||Week 6-HSS0104-Tiredness At It's Worst||0.92|-0.68|
73993385|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.96|0.63||||||Week 8-HSS0104-Tiredness At It's Worst||0.63|-0.96|
73993386|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.53|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.31|0.24||||||Week 8-HSS0104-Tiredness At It's Worst||0.24|-1.31|
73993387|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.11|STANDARD_ERROR_OF_MEAN|0.488|||TWO_SIDED|90.0|-0.69|0.92||||||Week 8-HSS0104-Tiredness At It's Worst||0.92|-0.69|
73993388|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.34|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.21|0.53||||||Week 12-HSS0104-Tiredness At It's Worst||0.53|-1.21|
73993389|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-1.64|0.02||||||Week 12-HSS0104-Tiredness At It's Worst||0.02|-1.64|
73993390|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-0.72|1.02||||||Week 12-HSS0104-Tiredness At It's Worst||1.02|-0.72|
73993391|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-0.7|1.15||||||Week 16-HSS0104-Tiredness At It's Worst||1.15|-0.70|
73993392|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-1.44|0.32||||||Week 16-HSS0104-Tiredness At It's Worst||0.32|-1.44|
73993393|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.557|||TWO_SIDED|90.0|-0.83|1.01||||||Week 16-HSS0104-Tiredness At It's Worst||1.01|-0.83|
73993394|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|90.0|-0.39|0.49||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.49|-0.39|
73993395|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.257|||TWO_SIDED|90.0|-0.75|0.1||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.10|-0.75|
73993396|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.46|0.42||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.42|-0.46|
73993397|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.65|0.45||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.45|-0.65|
73993398|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|90.0|-1.33|-0.27||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||-0.27|-1.33|
73993399|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.36|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.91|0.19||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.19|-0.91|
73993400|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.36|1.0||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||1.00|-0.36|
73993401|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.94|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|90.0|-1.59|-0.29||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||-0.29|-1.59|
73993402|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.29|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.97|0.39||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||0.39|-0.97|
73993403|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.55|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-0.2|1.3||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||1.30|-0.20|
73993404|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.69|STANDARD_ERROR_OF_MEAN|0.439|||TWO_SIDED|90.0|-1.41|0.04||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.04|-1.41|
73993405|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.456|||TWO_SIDED|90.0|-0.85|0.66||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.85|
73993406|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.491|||TWO_SIDED|90.0|-0.96|0.66||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.96|
73993407|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|90.0|-1.89|-0.33||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||-0.33|-1.89|
73993408|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.497|||TWO_SIDED|90.0|-1.13|0.52||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.52|-1.13|
73993409|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.86|0.95||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||0.95|-0.86|
73993410|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.87|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.73|-0.01||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||-0.01|-1.73|
73993411|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.78|1.03||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||1.03|-0.78|
73993412|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.602|||TWO_SIDED|90.0|-0.6|1.39||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||1.39|-0.60|
73876633|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||33.1|-50.2|1.000
73876634|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||45.5|-72.2|1.000
73993413|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.95|STANDARD_ERROR_OF_MEAN|0.574|||TWO_SIDED|90.0|-1.9|0.0||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.00|-1.90|
73993414|NCT04092452|147533312|SUPERIORITY||Risk Difference (RD)|-0.01|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.0|0.99||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.99|-1.00|
73993415|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.69|0.29||||||Week 1-HSS0101-Pain At It's Worst||0.29|-0.69|
73993416|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|90.0|-0.96|-0.01||||||Week 1-HSS0101-Pain At It's Worst||-0.01|-0.96|
74035660|NCT04047121|147623970|SUPERIORITY|||||||0.1473|||||||t-test, 2 sided|||||||0.1473
73993417|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.91|0.06||||||Week 1-HSS0101-Pain At It's Worst||0.06|-0.91|
73993418|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|90.0|-0.95|0.35||||||Week 2-HSS0101-Pain At It's Worst||0.35|-0.95|
73993419|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.71|STANDARD_ERROR_OF_MEAN|0.377|||TWO_SIDED|90.0|-1.33|-0.08||||||Week 2-HSS0101-Pain At It's Worst||-0.08|-1.33|
73993420|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.391|||TWO_SIDED|90.0|-1.21|0.08||||||Week 2-HSS0101-Pain At It's Worst||0.08|-1.21|
73993421|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.481|||TWO_SIDED|90.0|-0.54|1.05||||||Week 4-HSS0101-Pain At It's Worst||1.05|-0.54|
73993422|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|90.0|-1.15|0.37||||||Week 4-HSS0101-Pain At It's Worst||0.37|-1.15|
73993423|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.478|||TWO_SIDED|90.0|-0.85|0.73||||||Week 4-HSS0101-Pain At It's Worst||0.73|-0.85|
73993424|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.62|STANDARD_ERROR_OF_MEAN|0.524|||TWO_SIDED|90.0|-0.24|1.49||||||Week 6-HSS0101-Pain At It's Worst||1.49|-0.24|
73993425|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.19|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.03|0.64||||||Week 6-HSS0101-Pain At It's Worst||0.64|-1.03|
73993426|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|90.0|-0.66|1.08||||||Week 6-HSS0101-Pain At It's Worst||1.08|-0.66|
73993427|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.558|||TWO_SIDED|90.0|-0.69|1.16||||||Week 8-HSS0101-Pain At It's Worst||1.16|-0.69|
73993428|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.539|||TWO_SIDED|90.0|-1.21|0.57||||||Week 8-HSS0101-Pain At It's Worst||0.57|-1.21|
73993429|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|90.0|-0.49|1.38||||||Week 8-HSS0101-Pain At It's Worst||1.38|-0.49|
73993430|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.578|||TWO_SIDED|90.0|-0.79|1.12||||||Week 12-HSS0101-Pain At It's Worst||1.12|-0.79|
73993431|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-1.59|0.23||||||Week 12-HSS0101-Pain At It's Worst||0.23|-1.59|
73993432|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.576|||TWO_SIDED|90.0|-0.88|1.03||||||Week 12-HSS0101-Pain At It's Worst||1.03|-0.88|
73993433|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.631|||TWO_SIDED|90.0|-0.96|1.13||||||Week 16-HSS0101-Pain At It's Worst||1.13|-0.96|
73993434|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-1.25|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.24|-0.25||||||Week 16-HSS0101-Pain At It's Worst||-0.25|-2.24|
73993435|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.91|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|90.0|-1.95|0.13||||||Week 16-HSS0101-Pain At It's Worst||0.13|-1.95|
74035661|NCT04047121|147623970|SUPERIORITY|||||||0.8747|||||||t-test, 2 sided|||||||0.8747
74035662|NCT04047121|147623970|SUPERIORITY|||||||0.5265|||||||t-test, 2 sided|||||||0.5265
74035663|NCT04047121|147623970|SUPERIORITY||Odds Ratio (OR)|-0.0457||||0.2522|TWO_SIDED|95.0|-0.1239|0.0325|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0325|-0.1239|0.2522
74039709|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0273|TWO_SIDED|95.0|1.03|1.72|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.72|1.03|0.0273
73876635|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-54.7|68.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||68.0|-54.7|1.000
73876636|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|11.4||||1|TWO_SIDED|95.0|-33.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||56.6|-33.8|1.000
73876637|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-54.7|68.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||68.0|-54.7|1.000
73876638|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
73993436|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.47|0.48||||||Week 1-HSS0102-Tenderness At It's Worst||0.48|-0.47|
73993437|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.75|0.18||||||Week 1-HSS0102-Tenderness At It's Worst||0.18|-0.75|
73993438|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.78|0.17||||||Week 1-HSS0102-Tenderness At It's Worst||0.17|-0.78|
73993439|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.22|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|90.0|-0.81|0.38||||||Week 2-HSS0102-Tenderness At It's Worst||0.38|-0.81|
73993440|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.347|||TWO_SIDED|90.0|-0.97|0.18||||||Week 2-HSS0102-Tenderness At It's Worst||0.18|-0.97|
73876639|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-100.0|1.000
73993441|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.14||||||Week 2-HSS0102-Tenderness At It's Worst||0.14|-1.05|
73993442|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.471|||TWO_SIDED|90.0|-0.56|1.0||||||Week 4-HSS0102-Tenderness At It's Worst||1.00|-0.56|
73993443|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|90.0|-0.99|0.49||||||Week 4-HSS0102-Tenderness At It's Worst||0.49|-0.99|
73993444|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.11|STANDARD_ERROR_OF_MEAN|0.468|||TWO_SIDED|90.0|-0.88|0.67||||||Week 4-HSS0102-Tenderness At It's Worst||0.67|-0.88|
73993445|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.48|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|-0.38|1.34||||||Week 6-HSS0102-Tenderness At It's Worst||1.34|-0.38|
74035664|NCT04047121|147623970|SUPERIORITY||Odds Ratio (OR)|0.0278||||0.6701|TWO_SIDED|95.0|-0.1003|0.1559|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1559|-0.1003|0.6701
73993446|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-1.06|0.6||||||Week 6-HSS0102-Tenderness At It's Worst||0.60|-1.06|
73993447|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-0.86|0.87||||||Week 6-HSS0102-Tenderness At It's Worst||0.87|-0.86|
73993448|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.542|||TWO_SIDED|90.0|-0.81|0.99||||||Week 8-HSS0102-Tenderness At It's Worst||0.99|-0.81|
73993449|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.11|0.62||||||Week 8-HSS0102-Tenderness At It's Worst||0.62|-1.11|
73993450|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.549|||TWO_SIDED|90.0|-0.56|1.25||||||Week 8-HSS0102-Tenderness At It's Worst||1.25|-0.56|
73993451|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.554|||TWO_SIDED|90.0|-0.87|0.97||||||Week 12-HSS0102-Tenderness At It's Worst||0.97|-0.87|
73993452|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.49|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.36|0.38||||||Week 12-HSS0102-Tenderness At It's Worst||0.38|-1.36|
73993453|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.552|||TWO_SIDED|90.0|-0.9|0.93||||||Week 12-HSS0102-Tenderness At It's Worst||0.93|-0.90|
73993454|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.606|||TWO_SIDED|90.0|-0.96|1.04||||||Week 16-HSS0102-Tenderness At It's Worst||1.04|-0.96|
73993455|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-1.24|STANDARD_ERROR_OF_MEAN|0.577|||TWO_SIDED|90.0|-2.19|-0.29||||||Week 16-HSS0102-Tenderness At It's Worst||-0.29|-2.19|
74035665|NCT04047121|147623970|SUPERIORITY||Odds Ratio (OR)|0.1693||||0.1017|TWO_SIDED|95.0|-0.0334|0.372|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3720|-0.0334|0.1017
74035666|NCT04047121|147623971|SUPERIORITY|||||||0.2246|||||||t-test, 2 sided|||||||0.2246
74035667|NCT04047121|147623971|SUPERIORITY|||||||0.2101|||||||t-test, 2 sided|||||||0.2101
74035668|NCT04047121|147623971|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.0030
73993456|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 16-HSS0102-Tenderness At It's Worst||-0.11|-2.11|
73993457|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.284|||TWO_SIDED|90.0|-0.57|0.37||||||Week 1-HSS0103-Swelling At It's Worst||0.37|-0.57|
73993458|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.69|0.22||||||Week 1-HSS0103-Swelling At It's Worst||0.22|-0.69|
73993459|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.285|||TWO_SIDED|90.0|-0.94|0.01||||||Week 1-HSS0103-Swelling At It's Worst||0.01|-0.94|
73993460|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.24|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.83|0.35||||||Week 2-HSS0103-Swelling At It's Worst||0.35|-0.83|
73993461|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|90.0|-1.03|0.11||||||Week 2-HSS0103-Swelling At It's Worst||0.11|-1.03|
73993462|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.99|0.19||||||Week 2-HSS0103-Swelling At It's Worst||0.19|-0.99|
73993463|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.446|||TWO_SIDED|90.0|-0.58|0.9||||||Week 4-HSS0103-Swelling At It's Worst||0.90|-0.58|
73993464|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.424|||TWO_SIDED|90.0|-0.87|0.53||||||Week 4-HSS0103-Swelling At It's Worst||0.53|-0.87|
73993465|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|90.0|-0.65|0.82||||||Week 4-HSS0103-Swelling At It's Worst||0.82|-0.65|
73993466|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|90.0|-0.15|1.54||||||Week 6-HSS0103-Swelling At It's Worst||1.54|-0.15|
73993467|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.493|||TWO_SIDED|90.0|-0.83|0.8||||||Week 6-HSS0103-Swelling At It's Worst||0.80|-0.83|
73993468|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.513|||TWO_SIDED|90.0|-0.62|1.08||||||Week 6-HSS0103-Swelling At It's Worst||1.08|-0.62|
73993469|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.29|STANDARD_ERROR_OF_MEAN|0.507|||TWO_SIDED|90.0|-0.55|1.13||||||Week 8-HSS0103-Swelling At It's Worst||1.13|-0.55|
73993470|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-0.81|0.81||||||Week 8-HSS0103-Swelling At It's Worst||0.81|-0.81|
73993471|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.514|||TWO_SIDED|90.0|-0.35|1.35||||||Week 8-HSS0103-Swelling At It's Worst||1.35|-0.35|
73993472|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-0.81|0.95||||||Week 12-HSS0103-Swelling At It's Worst||0.95|-0.81|
73993473|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.3|0.37||||||Week 12-HSS0103-Swelling At It's Worst||0.37|-1.30|
74090111|NCT03265288|147733460|SUPERIORITY||Least square means difference|1.2258||||0.0486|TWO_SIDED|95.0|0.0078|2.4438||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Secondary analysis of the overall treatment effect from baseline through Week 24 on the per protocol population (PP), null hypothesis is no treatment difference||2.4438|0.0078|0.0486
74090112|NCT03265288|147733460|SUPERIORITY||Least square means difference|2.6628||||0.0687|TWO_SIDED|95.0|-0.2069|5.5325||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for stratification factor ppFEV1 (\<70% or ≥70%) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup ≥70%, n=29 (LAU-7b), n=27 (Placebo)"||5.5325|-0.2069|0.0687
73993474|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.92|0.84||||||Week 12-HSS0103-Swelling At It's Worst||0.84|-0.92|
73993475|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|90.0|-0.75|1.2||||||Week 16-HSS0103-Swelling At It's Worst||1.20|-0.75|
73993476|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-1.06|STANDARD_ERROR_OF_MEAN|0.561|||TWO_SIDED|90.0|-1.99|-0.13||||||Week 16-HSS0103-Swelling At It's Worst||-0.13|-1.99|
73993477|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-1.02|STANDARD_ERROR_OF_MEAN|0.586|||TWO_SIDED|90.0|-1.99|-0.05||||||Week 16-HSS0103-Swelling At It's Worst||-0.05|-1.99|
73993478|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.27|0.59||||||Week 1-HSS0104-Tiredness At It's Worst||0.59|-0.27|
73993479|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|-0.99|-0.15||||||Week 1-HSS0104-Tiredness At It's Worst||-0.15|-0.99|
73993480|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.35|0.52||||||Week 1-HSS0104-Tiredness At It's Worst||0.52|-0.35|
73993481|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.54|0.65||||||Week 2-HSS0104-Tiredness At It's Worst||0.65|-0.54|
73993482|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.44|STANDARD_ERROR_OF_MEAN|0.344|||TWO_SIDED|90.0|-1.01|0.13||||||Week 2-HSS0104-Tiredness At It's Worst||0.13|-1.01|
73993483|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.356|||TWO_SIDED|90.0|-0.33|0.85||||||Week 2-HSS0104-Tiredness At It's Worst||0.85|-0.33|
73993484|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.12|STANDARD_ERROR_OF_MEAN|0.434|||TWO_SIDED|90.0|-0.83|0.6||||||Week 4-HSS0104-Tiredness At It's Worst||0.60|-0.83|
73993485|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.414|||TWO_SIDED|90.0|-1.49|-0.12||||||Week 4-HSS0104-Tiredness At It's Worst||-0.12|-1.49|
73993486|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.14|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|90.0|-0.86|0.57||||||Week 4-HSS0104-Tiredness At It's Worst||0.57|-0.86|
73993487|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.76|0.84||||||Week 6-HSS0104-Tiredness At It's Worst||0.84|-0.76|
73993488|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.52|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.29|0.26||||||Week 6-HSS0104-Tiredness At It's Worst||0.26|-1.29|
73993489|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.485|||TWO_SIDED|90.0|-0.68|0.92||||||Week 6-HSS0104-Tiredness At It's Worst||0.92|-0.68|
73993490|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.96|0.63||||||Week 8-HSS0104-Tiredness At It's Worst||0.63|-0.96|
73993491|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.53|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.31|0.24||||||Week 8-HSS0104-Tiredness At It's Worst||0.24|-1.31|
73993492|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.11|STANDARD_ERROR_OF_MEAN|0.488|||TWO_SIDED|90.0|-0.69|0.92||||||Week 8-HSS0104-Tiredness At It's Worst||0.92|-0.69|
73993493|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.34|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.21|0.53||||||Week 12-HSS0104-Tiredness At It's Worst||0.53|-1.21|
73993494|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-1.64|0.02||||||Week 12-HSS0104-Tiredness At It's Worst||0.02|-1.64|
73993495|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-0.72|1.02||||||Week 12-HSS0104-Tiredness At It's Worst||1.02|-0.72|
73993496|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-0.7|1.15||||||Week 16-HSS0104-Tiredness At It's Worst||1.15|-0.70|
73993497|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-1.44|0.32||||||Week 16-HSS0104-Tiredness At It's Worst||0.32|-1.44|
74035669|NCT04047121|147623971|SUPERIORITY||Odds Ratio (OR)|0.414||||0.3324|TWO_SIDED|95.0|-0.4231|1.2511|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2511|-0.4231|0.3324
73993498|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.557|||TWO_SIDED|90.0|-0.83|1.01||||||Week 16-HSS0104-Tiredness At It's Worst||1.01|-0.83|
73993499|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|90.0|-0.39|0.49||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.49|-0.39|
73993500|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.257|||TWO_SIDED|90.0|-0.75|0.1||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.10|-0.75|
73993501|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.46|0.42||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.42|-0.46|
73993502|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.65|0.45||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.45|-0.65|
73993503|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|90.0|-1.33|-0.27||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||-0.27|-1.33|
73993504|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.36|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.91|0.19||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.19|-0.91|
73993505|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.36|1.0||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||1.00|-0.36|
73993506|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.94|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|90.0|-1.59|-0.29||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||-0.29|-1.59|
73993507|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.29|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.97|0.39||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||0.39|-0.97|
73993508|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.55|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-0.2|1.3||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||1.30|-0.20|
73993509|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.69|STANDARD_ERROR_OF_MEAN|0.439|||TWO_SIDED|90.0|-1.41|0.04||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.04|-1.41|
73993510|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.456|||TWO_SIDED|90.0|-0.85|0.66||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.85|
73993511|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.491|||TWO_SIDED|90.0|-0.96|0.66||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.96|
73993512|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|90.0|-1.89|-0.33||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||-0.33|-1.89|
73993513|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.497|||TWO_SIDED|90.0|-1.13|0.52||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.52|-1.13|
73993514|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.86|0.95||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||0.95|-0.86|
73993515|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.87|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.73|-0.01||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||-0.01|-1.73|
73993516|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.78|1.03||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||1.03|-0.78|
73993517|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.602|||TWO_SIDED|90.0|-0.6|1.39||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||1.39|-0.60|
73993518|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.95|STANDARD_ERROR_OF_MEAN|0.574|||TWO_SIDED|90.0|-1.9|0.0||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.00|-1.90|
73993519|NCT04092452|147533313|SUPERIORITY||Risk Difference (RD)|-0.01|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.0|0.99||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.99|-1.00|
74035670|NCT04047121|147623971|SUPERIORITY||Odds Ratio (OR)|1.1712||||0.1367|TWO_SIDED|95.0|-0.3713|2.7138|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.7138|-0.3713|0.1367
74035671|NCT04047121|147623971|SUPERIORITY||Odds Ratio (OR)|1.8099||||0.0028|TWO_SIDED|95.0|0.6219|2.9978|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.9978|0.6219|0.0028
74035672|NCT04047121|147623972|SUPERIORITY|||||||0.2667|||||||t-test, 2 sided|||||||0.2667
74035673|NCT04047121|147623972|SUPERIORITY|||||||0.657|||||||t-test, 2 sided|||||||0.6570
74035674|NCT04047121|147623972|SUPERIORITY|||||||0.5403|||||||t-test, 2 sided|||||||0.5403
73876640|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
73876641|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||86.7|-20.0|1.000
73876642|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||70.8|-100.0|1.000
73876643|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||86.7|-20.0|1.000
73876644|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-100.0|42.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||42.1|-100.0|1.000
73876645|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||70.8|-100.0|1.000
73876646|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||86.7|-20.0|1.000
73993520|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-1.7|2.6||||||Week 4||2.6|-1.7|
73993521|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-2.7|1.7||||||Week 4||1.7|-2.7|
73993522|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.4|3.2||||||Week 4||3.2|-1.4|
73993523|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-2.7|1.6||||||Week 8||1.6|-2.7|
73993524|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|-1.1|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.3|1.0||||||Week 8||1.0|-3.3|
74090113|NCT03265288|147733460|SUPERIORITY||Least square means difference|1.391||||0.236|TWO_SIDED|95.0|-0.922|3.7041||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for stratification factor co-administration of CFTR modulator (yes/no) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup receiving CFTR modulators, n=41 (LAU-7b), n=46 (Placebo)"||3.7041|-0.9220|0.236
73993525|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|90.0|-2.2|2.2||||||Week 8||2.2|-2.2|
73993526|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|90.0|-3.2|1.6||||||Week 12||1.6|-3.2|
73993527|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|90.0|-4.3|0.3||||||Week 12||0.3|-4.3|
73993528|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-2.6|2.2||||||Week 12||2.2|-2.6|
73993529|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.7|4.2||||||Week 16||4.2|-0.7|
73993530|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-3.6|1.2||||||Week 16||1.2|-3.6|
73993531|NCT04092452|147533314|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.4|2.6||||||Week 16||2.6|-2.4|
73993532|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-1.7|2.6||||||Week 4||2.6|-1.7|
73993533|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-2.7|1.7||||||Week 4||1.7|-2.7|
73993534|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.4|3.2||||||Week 4||3.2|-1.4|
73993535|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-2.7|1.6||||||Week 8||1.6|-2.7|
73993536|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|-1.1|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.3|1.0||||||Week 8||1.0|-3.3|
73993537|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|90.0|-2.2|2.2||||||Week 8||2.2|-2.2|
73993538|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|90.0|-3.2|1.6||||||Week 12||1.6|-3.2|
73993539|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|90.0|-4.3|0.3||||||Week 12||0.3|-4.3|
73876647|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-75.4|75.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||75.4|-75.4|1.000
73993540|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-2.6|2.2||||||Week 12||2.2|-2.6|
73993541|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.7|4.2||||||Week 16||4.2|-0.7|
73993542|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-3.6|1.2||||||Week 16||1.2|-3.6|
73993543|NCT04092452|147533315|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.4|2.6||||||Week 16||2.6|-2.4|
73993544|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-9.1|9.5||||||Week 4||9.5|-9.1|
73993545|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|1.2|STANDARD_ERROR_OF_MEAN|5.25|||TWO_SIDED|90.0|-7.4|9.8||||||Week 4||9.8|-7.4|
73993546|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|4.52|||TWO_SIDED|90.0|-11.4|3.4||||||Week 4||3.4|-11.4|
73993547|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|4.3|STANDARD_ERROR_OF_MEAN|4.57|||TWO_SIDED|90.0|-3.3|11.8||||||Week 8||11.8|-3.3|
73993548|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|6.2|STANDARD_ERROR_OF_MEAN|4.87|||TWO_SIDED|90.0|-1.8|14.2||||||Week 8||14.2|-1.8|
73993549|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|2.5|STANDARD_DEVIATION|4.42|||TWO_SIDED|90.0|-4.8|9.8||||||Week 8||9.8|-4.8|
73876648|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||70.8|-100.0|1.000
73993550|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|5.43|||TWO_SIDED|90.0|-1.3|16.5||||||Week 12||16.5|-1.3|
73993551|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|6.9|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|90.0|-2.0|15.7||||||Week 12||15.7|-2.0|
73993552|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|2.9|STANDARD_ERROR_OF_MEAN|5.09|||TWO_SIDED|90.0|-5.5|11.3||||||Week 12||11.3|-5.5|
74090114|NCT03265288|147733460|SUPERIORITY||Least square means difference|1.1302||||0.5323|TWO_SIDED|95.0|-2.4447|4.7052||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for à priori defined subgroup co-administration of ETI - elexacaftor/tezacaftor/ivacaftor (yes/no) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup receiving ETI, n=18 (LAU-7b), n=23 (Placebo)"||4.7052|-2.4447|0.5323
73993553|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.88|||TWO_SIDED|90.0|-6.3|6.4||||||Week 16||6.4|-6.3|
73993554|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|6.5|STANDARD_ERROR_OF_MEAN|5.63|||TWO_SIDED|90.0|-2.8|15.7||||||Week 16||15.7|-2.8|
74090115|NCT03265288|147733462|SUPERIORITY||Odds Ratio (OR)|0.5036||||0.1047|TWO_SIDED|95.0|0.2199|1.1532||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of Arachidonic Acid (AA) during treatment Intent to treat population (ITT), null hypothesis is no treatment effect||1.1532|0.2199|0.1047
73993555|NCT04092452|147533316|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-1.6|16.9||||||Week 16||16.9|-1.6|
73993556|NCT02127125|147533318|SUPERIORITY||||||<|0.025||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||<0.025
73993557|NCT02127125|147533318|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
73993558|NCT02127125|147533319|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
73993559|NCT02127125|147533319|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
73993560|NCT02127125|147533320|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.||||>0.05
73993561|NCT02127125|147533320|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.||||>0.05
73993562|NCT02097303|147533323|OTHER||||||<|1e-05||||||Comparison of ALP levels before and after treatment|t-test, 2 sided|||||||<.00001
73993563|NCT02097303|147533323|OTHER|||||||0.487||||||Comparison of PSA levels before and after treatment|t-test, 2 sided|||||||0.4870
73993564|NCT02975102|147533328|NON_INFERIORITY|A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-101 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.2|0.3|||||Treatment difference : CBL-101 - Vismed Multi|||0.3|-1.2|
73993565|NCT02975102|147533329|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
73993566|NCT02975102|147533330|SUPERIORITY|||||||0.0002||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0002
73993567|NCT02975102|147533331|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
73993568|NCT02975102|147533332|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
73993569|NCT02975102|147533333|SUPERIORITY|||||||0.0186||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0186
73993570|NCT02975102|147533334|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
73876649|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||86.7|-20.0|1.000
73993571|NCT02975102|147533335|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
73993572|NCT02975102|147533336|SUPERIORITY|||||||0.0011||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0011
73993573|NCT02975102|147533337|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
74090116|NCT03265288|147733462|SUPERIORITY||Odds Ratio (OR)|0.8773||||0.7596|TWO_SIDED|95.0|0.3793|2.0291||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of Docosahexaenoic Acid (DHA) during treatment Intent to treat population (ITT, null hypothesis is no treatment effect||2.0291|0.3793|0.7596
73993574|NCT02975102|147533338|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
73993575|NCT02975102|147533339|SUPERIORITY|||||||0.005||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.005
73993576|NCT02975102|147533340|SUPERIORITY|||||||0.0008||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0008
73993577|NCT02975102|147533341|SUPERIORITY|||||||0.0026||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0026
73876650|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-75.4|75.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||75.4|-75.4|1.000
73993578|NCT02975102|147533342|SUPERIORITY|||||||0.077||||||Significance level of 0.05 . P-Value result provided only for Global Question|ANCOVA|Adjustment for baseline||||||0.077
73993579|NCT02975102|147533343|SUPERIORITY|||||||0.6097||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.6097
73993580|NCT02975102|147533344|SUPERIORITY|||||||0.231||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.231
73993581|NCT02975102|147533345|SUPERIORITY|||||||0.0135||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0135
73993582|NCT02975102|147533346|SUPERIORITY|||||||0.575||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.575
73993583|NCT01727505|147533354|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon signed rank test|||||||0.44
73993584|NCT01727505|147533355|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon signed rank test|||||||.75
73993585|NCT01727505|147533356|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon signed rank test|||||||0.2
73993586|NCT01727505|147533357|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon signed rank test|||||||0.02
73993587|NCT01727505|147533358|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon signed rank test|||||||.049
73993588|NCT01727505|147533359|SUPERIORITY_OR_OTHER|||||||0.006|||||||Paired t-test|||||||0.006
73993589|NCT01441635|147533360|SUPERIORITY||LS Mean Difference|-205.9|STANDARD_ERROR_OF_MEAN|45.1|<|0.001|TWO_SIDED|95.0|-295.77|-116.01|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-116.01|-295.77|< 0.001
73993590|NCT01441635|147533360|SUPERIORITY||LS Mean Difference|-189.9|STANDARD_ERROR_OF_MEAN|44.36|<|0.001|TWO_SIDED|95.0|-278.33|-101.53|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-101.53|-278.33|< 0.001
73993591|NCT01441635|147533360|SUPERIORITY||LS Mean Difference|-138.0|STANDARD_ERROR_OF_MEAN|40.86||0.001|TWO_SIDED|95.0|-220.18|-55.76|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-55.76|-220.18|0.001
73993592|NCT01441635|147533360|SUPERIORITY||LS Mean Difference|-130.6|STANDARD_ERROR_OF_MEAN|37.68||0.001|TWO_SIDED|95.0|-206.7|-54.6|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-54.60|-206.70|0.001
73993593|NCT01441635|147533361|SUPERIORITY||LS Mean Difference|-75.6|STANDARD_ERROR_OF_MEAN|13.71|<|0.001|TWO_SIDED|95.0|-102.93|-48.28|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-48.28|-102.93|< 0.001
73993594|NCT01441635|147533361|SUPERIORITY||LS Mean Difference|-64.27|STANDARD_ERROR_OF_MEAN|13.48|<|0.001|TWO_SIDED|95.0|-91.14|-37.39|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-37.39|-91.14|< 0.001
73993595|NCT01441635|147533361|SUPERIORITY||LS Mean Difference|-67.67|STANDARD_ERROR_OF_MEAN|22.73||0.005|TWO_SIDED|95.0|-113.39|-21.96|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-21.96|-113.39|0.005
73993596|NCT01441635|147533361|SUPERIORITY||LS mean Difference|-56.84|STANDARD_ERROR_OF_MEAN|8.12|<|0.001|TWO_SIDED|95.0|-73.24|-40.45|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-40.45|-73.24|< 0.001
73993597|NCT01441635|147533362|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73876651|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-86.7|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||20.0|-86.7|1.000
73876652|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|66.7||||1|TWO_SIDED|95.0|13.3|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|13.3|1.000
73876653|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|6.4||||1|TWO_SIDED|90.0|-31.2|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||44.0|-31.2|1.000
73876654|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||28.1|-48.6|0.655
73876655|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|23.1||||0.541|TWO_SIDED|95.0|0.2|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||46.0|0.2|0.541
73876656|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-1.3||||1|TWO_SIDED|95.0|-37.0|34.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||34.4|-37.0|1.000
73876657|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-29.1||||0.178|TWO_SIDED|95.0|-67.0|8.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||8.9|-67.0|0.178
73876658|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|15.4||||1|TWO_SIDED|95.0|-4.2|35.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||35.0|-4.2|1.000
73993598|NCT01441635|147533362|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73993599|NCT01441635|147533362|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73993600|NCT01441635|147533362|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73993601|NCT01441635|147533363|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73876659|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-10.3||||1|TWO_SIDED|95.0|-54.4|33.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||33.9|-54.4|1.000
73993602|NCT01441635|147533363|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73993603|NCT01441635|147533363|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73993604|NCT01441635|147533363|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73993605|NCT01441635|147533364|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73993606|NCT01441635|147533364|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73993607|NCT01441635|147533364|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73993608|NCT01441635|147533364|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73993609|NCT01441635|147533366|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|0.97|2.56|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||2.56|0.97|< 0.001
73993610|NCT01441635|147533366|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|1.0|2.56|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||2.56|1.00|< 0.001
73993611|NCT01441635|147533366|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.4||0.024|TWO_SIDED|95.0|0.13|1.75|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.75|0.13|0.024
73993612|NCT01441635|147533366|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|0.28|1.51|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.51|0.28|0.005
73993613|NCT01441635|147533367|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.14||0.011|TWO_SIDED|95.0|-0.63|-0.08|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.08|-0.63|0.011
73993614|NCT01441635|147533367|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.03|TWO_SIDED|95.0|-0.59|-0.03|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.03|-0.59|0.030
73993615|NCT01441635|147533367|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.109|TWO_SIDED|95.0|-0.59|0.06|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||0.06|-0.59|0.109
73993616|NCT01441635|147533367|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.002|TWO_SIDED|95.0|-0.8|-0.19|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.19|-0.80|0.002
73993617|NCT01441635|147533368|SUPERIORITY||LS Mean Difference|-10.29|STANDARD_ERROR_OF_MEAN|4.32||0.02|TWO_SIDED|95.0|-18.9|-1.67|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-1.67|-18.90|0.020
73876660|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||28.1|-48.6|0.655
73876661|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-1.9||||1|TWO_SIDED|95.0|-50.1|46.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||46.3|-50.1|1.000
73876662|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-26.9||||0.32|TWO_SIDED|95.0|-73.0|19.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||19.2|-73.0|0.320
73876663|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||28.1|-48.6|0.655
73876664|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-1.9||||1|TWO_SIDED|95.0|-50.1|46.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.3|-50.1|1.000
73876665|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-52.2|44.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||44.5|-52.2|1.000
73876666|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|1.7||||1|TWO_SIDED|95.0|-40.6|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||44.0|-40.6|1.000
73993618|NCT01441635|147533368|SUPERIORITY||LS Mean Difference|-7.62|STANDARD_ERROR_OF_MEAN|4.39||0.087|TWO_SIDED|95.0|-16.36|1.13|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.13|-16.36|0.087
73993619|NCT01441635|147533368|SUPERIORITY||LS Mean Difference|-8.81|STANDARD_ERROR_OF_MEAN|4.28||0.045|TWO_SIDED|95.0|-17.43|-0.19|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.19|-17.43|0.045
73993620|NCT01441635|147533368|SUPERIORITY||LS Mean Difference|-13.69|STANDARD_ERROR_OF_MEAN|4.14||0.002|TWO_SIDED|95.0|-22.06|-5.32|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-5.32|-22.06|0.002
74090117|NCT03265288|147733462|SUPERIORITY||Odds Ratio (OR)|1.0532||||0.8852|TWO_SIDED|95.0|0.5209|2.1296||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of AA/DHA ratio during treatment Intent to treat population (ITT), null hypothesis is no treatment effect||2.1296|0.5209|0.8852
73876667|NCT02365649|147294841|SUPERIORITY||Risk Difference (RD)|21.2||||0.603|TWO_SIDED|95.0|-29.2|71.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||71.5|-29.2|0.603
74090118|NCT03265288|147733465|SUPERIORITY|||||||0.3025|||||||Log Rank|||||||0.3025
74090119|NCT03265288|147733466|SUPERIORITY||Risk Ratio (RR)|1.55||||0.3366|TWO_SIDED|95.0|0.63|3.8||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|Protocol-Defined IV antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||3.80|0.63|0.3366
73876668|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|15.4||||0.673|TWO_SIDED|95.0|-25.6|56.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||56.5|-25.6|0.673
73993621|NCT01441635|147533369|SUPERIORITY||LS Mean Difference|-5.51|STANDARD_ERROR_OF_MEAN|2.03||0.008|TWO_SIDED|95.0|-9.56|-1.47|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-1.47|-9.56|0.008
73993622|NCT01441635|147533369|SUPERIORITY||LS Mean Difference|-4.95|STANDARD_ERROR_OF_MEAN|2.08||0.02|TWO_SIDED|95.0|-9.11|-0.8|||ANCOVA|||||-0.80|-9.11|0.020
73993623|NCT01441635|147533369|SUPERIORITY||LS Mean Difference|-3.63|STANDARD_ERROR_OF_MEAN|2.75||0.194|TWO_SIDED|95.0|-9.18|1.91|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.91|-9.18|0.194
73993624|NCT01441635|147533369|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.04||0.001|TWO_SIDED|95.0|-11.33|-3.07|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-3.07|-11.33|0.001
73993625|NCT01441635|147533372|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
73876669|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|19.6||||0.265|TWO_SIDED|95.0|-14.0|53.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||53.3|-14.0|0.265
73876670|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|12.9||||0.695|TWO_SIDED|95.0|-25.6|51.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||51.5|-25.6|0.695
73876671|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-20.6||||0.394|TWO_SIDED|95.0|-61.4|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||20.3|-61.4|0.394
73876672|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-3.9||||1|TWO_SIDED|95.0|-36.1|28.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||28.3|-36.1|1.000
74090120|NCT03265288|147733466|OTHER||Risk Ratio (RR)|1.34||||0.3936|TWO_SIDED|95.0|0.68|2.64||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|ALL IV antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||2.64|0.68|0.3936
73993626|NCT01441635|147533372|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
73993627|NCT01441635|147533372|SUPERIORITY|||||||0.052|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.052
73993628|NCT01441635|147533372|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
73993629|NCT01441635|147533373|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
73993630|NCT01441635|147533373|SUPERIORITY|||||||0.016|||||||Fisher Exact|||||||0.016
73876673|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-10.6||||0.683|TWO_SIDED|95.0|-47.9|26.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||26.7|-47.9|0.683
73876674|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|28.7||||0.205|TWO_SIDED|95.0|-4.1|61.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||61.4|-4.1|0.205
73876675|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|14.5||||0.388|TWO_SIDED|95.0|-17.9|46.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||46.9|-17.9|0.388
73993631|NCT01441635|147533373|SUPERIORITY|||||||0.012|||||||Fisher Exact|||||||0.012
73993632|NCT01441635|147533373|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
73993633|NCT01441635|147533374|SUPERIORITY|||||||0.161|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor||||||0.161
73993634|NCT01441635|147533374|SUPERIORITY|||||||0.173|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.173
73993635|NCT01441635|147533374|SUPERIORITY|||||||0.072|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.072
73993636|NCT01441635|147533374|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.003
73993637|NCT01441635|147533375|SUPERIORITY|||||||0.203|||||||Fisher Exact|||||||0.203
73993638|NCT01441635|147533375|SUPERIORITY|||||||0.342|||||||Fisher Exact|||||||0.342
73993639|NCT01441635|147533375|SUPERIORITY|||||||0.038|||||||Fisher Exact|||||||0.038
73993640|NCT01441635|147533375|SUPERIORITY|||||||0.111|||||||Fisher Exact|||||||0.111
73993641|NCT03274895|147533382|NON_INFERIORITY|Non-inferiority margin= 0.20|difference in proportion of resolution r|-0.036|||||TWO_SIDED|95.0|-0.154|0.081||||||||0.081|-0.154|
73993642|NCT03274895|147533383|OTHER|||||||0.042|||||||Log Rank|||||||0.042
73993643|NCT03274895|147533384|OTHER|||||||0.577|||||||ANCOVA|||||||0.577
73993644|NCT03518567|147533419|SUPERIORITY||Slope|0.78||||4e-08|TWO_SIDED||||||Regression, Linear|"hits purchased on the MPT predicting hits actually purchased and smoked in the laboratory.~covariate: baseline total individual income"||||||.00000004
73993645|NCT03518567|147533420|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_DEVIATION|1.09||9e-09|TWO_SIDED||||||t-test, 2 sided|||||||.000000009
73993646|NCT03518567|147533421|SUPERIORITY||correlation|0.02||||0.87|TWO_SIDED||||||correlation|Correlation between puffs on the topography device and grams of cannabis used per week.||||||.87
73993647|NCT04982575|147533430|OTHER||Treatment difference|-0.3||||0.2284|TWO_SIDED|95.0|-0.79|0.19|||Mixed Models Analysis|||The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor as factors and baseline HbA1c as a covariate using retrieved participants multiple imputation of missing data regardless of treatment or stratification.||0.19|-0.79|0.2284
73993648|NCT01151423|147533440|SUPERIORITY||Hazard Ratio (HR)|2.2|||=|0.005|TWO_SIDED|95.0|1.28|3.78||Caplacizumab was compared to placebo using a one-sided log-rank test in order to assess superiority at 2.5% significance level.|Stratified log-rank test||The HR was estimated from a Cox proportional Hazards regression model with presence (yes) / absence (no) of 1 PE session prior to randomization as covariate.|The primary analysis consisted of a Kaplan-Meier analysis with time-to-response as endpoint and treatment group as the independent variable and stratified for absence/presence of one PE session prior to randomization.||3.78|1.28|= 0.005
73993649|NCT01483144|147533492|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.121|TWO_SIDED|95.0|0.4|1.3||The threshold for statistical significance is p=0.05|stratified Cox proportional (Score)||Eflornithine plus sulindac is the numerator and sulindac plus eflornithine placebo is the denominator.|Intent to treat population with all FAP-related events||1.3|0.4|0.1210
73993650|NCT01483144|147533492|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.1076|TWO_SIDED|95.0|0.4|1.2||The threshold for statistical significance is p=0.05|stratified Cox proportional (Score)||Eflornithine plus sulindac is the numerator and eflornithine plus sulindac placebo is the denominator.|Intent to treat population with all FAP-related events||1.2|0.4|0.1076
73993651|NCT01483144|147533492|SUPERIORITY||Hazard Ratio (HR)|0.2||||0.0201|TWO_SIDED|95.0|0.0|0.8||Threshold for statistical significance was p=0.05|stratified Cox proportional (Score)||Eflornithine and sulindac is the numerator and sulindac and eflornithine placebo is the denominator. Reduction in relative risk for FAP-related events with the combination.|Lower GI population||0.8|0.0|0.0201
73993652|NCT01483144|147533492|SUPERIORITY||Hazard Ratio (HR)|0.17||||0.0101|TWO_SIDED|95.0|0.0|0.7||Threshold of significance was p=0.05|stratified Cox proportional (Score)||Eflornithine and sulindac is the numerator and eflornithine and sulindac placebo is the denominator.|Lower GI population||0.7|0|0.0101
73993653|NCT01483144|147533493|SUPERIORITY|||||||0.8127||||||The threshold of significance was p=0.05|Mantel Haenszel|||||||0.8127
73993654|NCT01483144|147533493|SUPERIORITY|||||||0.8133||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.8133
73993655|NCT01483144|147533494|SUPERIORITY|||||||0.999||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.999
73993656|NCT01483144|147533494|SUPERIORITY|||||||0.2152||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.2152
73993657|NCT03258723|147533506|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||<0.0001
73993658|NCT03258723|147533507|SUPERIORITY|||||||0.0005|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.0005
73993659|NCT03258723|147533508|SUPERIORITY|||||||0.1809|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.1809
73993660|NCT03258723|147533509|SUPERIORITY|||||||0.0973|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.0973
73993661|NCT03258723|147533511|SUPERIORITY|||||||0.1992|||||||t-test, 2 sided|||Within subject change on matched cases.||||0.1992
73993662|NCT03258723|147533512|SUPERIORITY|||||||0.7017|||||||t-test, 2 sided|||Within subject change on matched cases.||||0.7017
73993663|NCT03258723|147533513|SUPERIORITY|||||||0.1573|||||||McNemar|||Within group change from baseline assessed on matched cases in low activity group at baseline.||||0.1573
73993664|NCT03258723|147533513|SUPERIORITY|||||||0.4328|||||||McNemar|||Within group change from baseline assessed on matched cases in medium activity group at baseline.||||0.4328
73993665|NCT03258723|147533513|SUPERIORITY|||||||0.6698|||||||McNemar|||Within group change from baseline assessed on matched cases in high activity group at baseline.||||0.6698
73993666|NCT03258723|147533514|SUPERIORITY|||||||0.5271|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.5271
73993667|NCT03258723|147533515|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||<0.0001
73993668|NCT02356705|147533516|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
73993669|NCT02356705|147533517|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
73993670|NCT02356705|147533518|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||0.88
73993671|NCT02356705|147533520|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
73993672|NCT02356705|147533521|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
73993673|NCT01107899|147533526|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the overall effect of initial inhibition on the day to return to baseline platelet function.|Regression, Linear|||||||<0.001
73993674|NCT01107899|147533528|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||<0.001
73993675|NCT01107899|147533528|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||<0.001
73993676|NCT01107899|147533528|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||0.025
73993677|NCT01810939|147533587|SUPERIORITY_OR_OTHER_LEGACY||Proportion|0.76|||||TWO_SIDED|95.0|0.7|0.81||||||||0.81|0.7|
73993678|NCT01810939|147533588|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.5 mEq/L||||<0.001
73993679|NCT01810939|147533589|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.1 mEq/L||||<0.001
73993680|NCT01810939|147533590|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Longitudinal mixed models|Test that the mean change is significantly different from zero.||Estimation of mean change in serum potassium from Part A Baseline to Part A Week 4 and test mean change different from zero.||||<0.001
73993681|NCT01810939|147533591|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Test for difference between treatment groups in serum potassium change in Part B||||< 0.001
74035675|NCT04047121|147623972|SUPERIORITY||Odds Ratio (OR)|0.9159||||0.1167|TWO_SIDED|95.0|-0.2283|2.06|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.0600|-0.2283|0.1167
74035676|NCT04047121|147623972|SUPERIORITY||Odds Ratio (OR)|-0.0336||||0.9722|TWO_SIDED|95.0|-1.9238|1.8567|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.8567|-1.9238|0.9722
74035677|NCT04047121|147623972|SUPERIORITY||Odds Ratio (OR)|0.2064||||0.8455|TWO_SIDED|95.0|-1.8689|2.2817|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2817|-1.8689|0.8455
74035678|NCT04047121|147623973|SUPERIORITY|||||||0.3142|||||||t-test, 2 sided|||||||0.3142
74035679|NCT04047121|147623973|SUPERIORITY|||||||0.2465|||||||t-test, 2 sided|||||||0.2465
74035680|NCT04047121|147623973|SUPERIORITY|||||||0.5933|||||||t-test, 2 sided|||||||0.5933
74035681|NCT04047121|147623973|SUPERIORITY||Odds Ratio (OR)|-0.0089||||0.7815|TWO_SIDED|95.0|-0.0716|0.0538|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0538|-0.0716|0.7815
73876676|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-28.8||||0.236|TWO_SIDED|95.0|-65.6|8.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||8.0|-65.6|0.236
73876677|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-9.6||||1|TWO_SIDED|95.0|-50.6|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.5|-50.6|1.000
74035682|NCT04047121|147623973|SUPERIORITY||Odds Ratio (OR)|0.0337||||0.4446|TWO_SIDED|95.0|-0.0528|0.1202|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1202|-0.0528|0.4446
74035683|NCT04047121|147623973|SUPERIORITY||Odds Ratio (OR)|-0.0333||||0.4733|TWO_SIDED|95.0|-0.1243|0.0577|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0577|-0.1243|0.4733
74035684|NCT04047121|147623974|SUPERIORITY|||||||0.0658|||||||t-test, 2 sided|||||||0.0658
74035685|NCT04047121|147623974|SUPERIORITY|||||||0.3785|||||||t-test, 2 sided|||||||0.3785
74035686|NCT04047121|147623974|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
74035687|NCT04047121|147623974|SUPERIORITY||Odds Ratio (OR)|-0.0425||||0.2523|TWO_SIDED|95.0|-0.1154|0.0303|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0303|-0.1154|0.2523
74035688|NCT04047121|147623974|SUPERIORITY||Odds Ratio (OR)|-0.0388||||0.4068|TWO_SIDED|95.0|-0.1305|0.0529|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0529|-0.1305|0.4068
74035689|NCT04047121|147623974|SUPERIORITY||Odds Ratio (OR)|0.0706||||0.5858|TWO_SIDED|95.0|-0.1833|0.3244|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3244|-0.1833|0.5858
74035690|NCT04047121|147623975|SUPERIORITY|||||||0.3832|||||||t-test, 2 sided|||||||0.3832
74035691|NCT04047121|147623975|SUPERIORITY|||||||0.4631|||||||t-test, 2 sided|||||||0.4631
74035692|NCT04047121|147623975|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
74035693|NCT04047121|147623975|SUPERIORITY||Odds Ratio (OR)|-0.5353||||0.3158|TWO_SIDED|95.0|-1.5812|0.5107|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.5107|-1.5812|0.3158
74035694|NCT04047121|147623975|SUPERIORITY||Odds Ratio (OR)|1.3543||||0.1016|TWO_SIDED|95.0|-0.2669|2.9755|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.9755|-0.2669|0.1016
74035695|NCT04047121|147623975|SUPERIORITY||Odds Ratio (OR)|0.8677||||0.2576|TWO_SIDED|95.0|-0.6347|2.37|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3700|-0.6347|0.2576
74035696|NCT04047121|147623976|SUPERIORITY|||||||0.3107|||||||t-test, 2 sided|||||||0.3107
74035697|NCT04047121|147623976|SUPERIORITY|||||||0.3735|||||||t-test, 2 sided|||||||0.3735
74035698|NCT04047121|147623976|SUPERIORITY|||||||0.3863|||||||t-test, 2 sided|||||||0.3863
74035699|NCT04047121|147623976|SUPERIORITY||Odds Ratio (OR)|-1.0337||||0.1918|TWO_SIDED|95.0|-2.5858|0.5184|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.5184|-2.5858|0.1918
74035700|NCT04047121|147623976|SUPERIORITY||Odds Ratio (OR)|-0.9749||||0.4281|TWO_SIDED|95.0|-3.3864|1.4366|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4366|-3.3864|0.4281
74035701|NCT04047121|147623976|SUPERIORITY||Odds Ratio (OR)|-1.8599||||0.1014|TWO_SIDED|95.0|-4.0854|0.3657|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3657|-4.0854|0.1014
73993682|NCT02349152|147533597|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.|Risk Ratio (RR)|1.9||||0.001|TWO_SIDED|95.0|1.3|3.0|||Chi-squared|||The null hypothesis that there was no difference in the percentage of patients with two or more blood glucose values greater than 180mg/dl between the two groups. Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%.||3.0|1.3|0.001
73993683|NCT02349152|147533598|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided|||||||0.004
73993684|NCT02349152|147533599|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.||||||0.01|||||||Fisher Exact|||||||0.01
73993685|NCT02349152|147533600|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0001|||||||t-test, 2 sided|||Mean Intraoperative Blood Glucose||||0.0001
73993686|NCT02349152|147533600|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0003|||||||t-test, 2 sided|||Peak Intraoperative Blood Glucose||||0.0003
73993687|NCT02349152|147533600|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.98|||||||t-test, 2 sided|||Lowest Intraoperative Blood Glucose||||0.98
73993688|NCT02349152|147533601|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.14|||||||t-test, 2 sided|||Mean post-operative glucose||||0.14
73993689|NCT02349152|147533601|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.25|||||||t-test, 2 sided|||Peak Postoperative Blood Glucose||||0.25
73993690|NCT02349152|147533602|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.49|||||||t-test, 2 sided|||||||0.49
73876678|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|26.3||||0.131|TWO_SIDED|95.0|-6.3|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||58.9|-6.3|0.131
73993691|NCT02349152|147533604|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.401|||||||t-test, 2 sided|||Prebypass||||0.401
73993692|NCT02349152|147533604|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||30 minutes after the start of CPB||||<0.0001
73993693|NCT02349152|147533604|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of CPB||||<0.0001
74035702|NCT04047121|147623977|SUPERIORITY|||||||0.4555|||||||t-test, 2 sided|||||||0.4555
74035703|NCT04047121|147623977|SUPERIORITY|||||||0.7164|||||||t-test, 2 sided|||||||0.7164
74035704|NCT04047121|147623977|SUPERIORITY|||||||0.2456|||||||t-test, 2 sided|||||||0.2456
73993694|NCT02349152|147533604|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of Surgery||||<0.0001
73993695|NCT02349152|147533604|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.021|||||||t-test, 2 sided|||Postoperative (8 hours)||||0.021
73993696|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.58|||||||t-test, 2 sided|||Analyzing the IL-1b Pre bypass||||0.580
73993697|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.815|||||||t-test, 2 sided|||Analyzing the IL-1b CPB-30||||0.815
73993698|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.715|||||||t-test, 2 sided|||Analyzing the CPB-END||||0.715
73993699|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.33|||||||t-test, 2 sided|||Analyzing the IL-1b post-bypass||||0.330
73993700|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.651|||||||t-test, 2 sided|||Analyzing the IL-1b 8 HR||||0.651
73993701|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.439|||||||t-test, 2 sided|||Analyzing the IL-6 Pre bypass||||0.439
73993702|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.284|||||||t-test, 2 sided|||Analyzing the IL-6 CPB-30||||0.284
73993703|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.779|||||||t-test, 2 sided|||Analyzing the CPB-END||||0.779
73993704|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.274|||||||t-test, 2 sided|||Analyzing the IL-6 post-bypass||||0.274
73993705|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.601|||||||t-test, 2 sided|||Analyzing the IL-6 8HR||||0.601
73993706|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.315|||||||t-test, 2 sided|||Analyzing the TNFa Pre-bypass||||0.315
74035705|NCT04047121|147623977|SUPERIORITY||Odds Ratio (OR)|0.0568||||0.0962|TWO_SIDED|95.0|-0.0101|0.1238|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1238|-0.0101|0.0962
73993707|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the TNFa CPB-30||||0.062
73993708|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.09|||||||t-test, 2 sided|||Analyzing the TNFa CPB-END||||0.090
73993709|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided|||Analyzing the TNFa- post-bypass||||0.004
73993710|NCT02349152|147533605|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.074|||||||t-test, 2 sided|||Analyzing the TNFa-8HR||||0.074
73993711|NCT02349152|147533606|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.74|||||||t-test, 2 sided|||Analyzing the ACTH Pre-bypass group||||0.740
73993712|NCT02349152|147533606|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-30 group.||||<0.0001
73993713|NCT02349152|147533606|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-END||||<0.0001
74035706|NCT04047121|147623977|SUPERIORITY||Odds Ratio (OR)|-0.0432||||0.3844|TWO_SIDED|95.0|-0.1405|0.0541|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0541|-0.1405|0.3844
73876679|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-7.1||||1|TWO_SIDED|95.0|-45.6|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.5|-45.6|1.000
73876680|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|21.3||||0.411|TWO_SIDED|95.0|-19.6|62.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||62.2|-19.6|0.411
73993714|NCT02349152|147533606|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH post-bypass||||<0.0001
73993715|NCT02349152|147533606|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.014|||||||t-test, 2 sided|||Analyzing the ACTH 8-hr||||0.014
73993716|NCT02349152|147533606|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.1|||||||t-test, 2 sided|||Analyzing the GH- Pre-bypass||||0.100
73993717|NCT02349152|147533606|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||GH-CPB-30||||<0.0001
73993718|NCT02349152|147533606|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.009|||||||t-test, 2 sided|||Analyzing the GH-CPB-END||||0.009
73993719|NCT02349152|147533606|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.046|||||||t-test, 2 sided|||GH-Post-bypass||||0.046
73993720|NCT02349152|147533606|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.695|||||||t-test, 2 sided|||Analyzing the GH-8-hr||||0.695
73993721|NCT02349152|147533606|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.455|||||||t-test, 2 sided|||Analyzing the Glucagon Pre Bypass||||0.455
73876681|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|32.2||||0.067|TWO_SIDED|95.0|-0.2|64.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||64.5|-0.2|0.067
73876682|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-1.2||||1|TWO_SIDED|95.0|-39.5|37.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||37.2|-39.5|1.000
73993722|NCT02349152|147533606|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.059|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-30||||0.059
73993723|NCT02349152|147533606|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.175|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-END||||0.175
73993724|NCT02349152|147533606|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the Glucagon Post-bypass||||0.062
73993725|NCT02349152|147533606|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.261|||||||t-test, 2 sided|||Analyzing the Glucagon 8-hr||||0.261
73993726|NCT02349152|147533607|SUPERIORITY|||||||0.06|||||||Chi-squared|||30-day mortality||||0.06
73993727|NCT02349152|147533607|SUPERIORITY|||||||0.03|||||||Chi-squared|||30-day readmission||||0.03
73993728|NCT02349152|147533607|SUPERIORITY|||||||0.24|||||||Chi-squared|||Cerebral Vascular Accident||||0.24
73993729|NCT02349152|147533607|SUPERIORITY|||||||0.93|||||||Chi-squared|||Prolonged Mechanical Ventilation||||0.93
73993730|NCT02349152|147533607|SUPERIORITY|||||||1|||||||Chi-squared|||Renal Failure||||1
73993731|NCT02349152|147533607|SUPERIORITY|||||||0.1|||||||Chi-squared|||Atrial Fibrillation||||0.10
73993732|NCT02349152|147533607|SUPERIORITY|||||||1|||||||Chi-squared|||cardiac arrest||||1
73993733|NCT02349152|147533608|SUPERIORITY|||||||0.205|||||||t-test, 2 sided|||Hrs 0-6||||0.205
73993734|NCT02349152|147533608|SUPERIORITY|||||||0.339|||||||t-test, 2 sided|||Hrs 7-12||||0.339
73993735|NCT02349152|147533608|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Hrs 13-18||||0.006
73993736|NCT02349152|147533608|SUPERIORITY|||||||0.747|||||||t-test, 2 sided|||Hrs 19-24||||0.747
73993737|NCT02349152|147533608|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Hrs 25-30||||0.568
73993738|NCT02349152|147533608|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||Hrs 31-36||||0.924
73993739|NCT02349152|147533608|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||Hrs 37-42||||0.501
73993740|NCT02349152|147533608|SUPERIORITY|||||||0.977|||||||t-test, 2 sided|||Hrs 43-48||||0.977
73993741|NCT02349152|147533612|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.350
73993742|NCT02330094|147533613|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
73993743|NCT02330094|147533614|SUPERIORITY|||||||0.79|||||||ANOVA|||||||0.79
73993744|NCT02330094|147533615|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
73993745|NCT00945672|147533682|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|3.959||0.9779|TWO_SIDED|90.0|-6.49|6.71|||Mixed Models Analysis|||Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.71|-6.49|0.9779
73993746|NCT00945672|147533682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|3.815||0.8801|TWO_SIDED|90.0|-5.79|6.94|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.94|-5.79|0.8801
74090121|NCT03265288|147733466|SUPERIORITY||Risk Ratio (RR)|1.16||||0.5011|TWO_SIDED|95.0|0.75|1.79||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|Combined IV- or Oral antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||1.79|0.75|0.5011
74090122|NCT03265288|147733467|SUPERIORITY|||||||0.1955|||||||Log Rank|||||||0.1955
73876683|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|26.6||||0.178|TWO_SIDED|95.0|-8.8|62.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||62.0|-8.8|0.178
73993747|NCT00945672|147533682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|3.845||0.9412|TWO_SIDED|90.0|-6.13|6.7|||Mixed Models Analysis|||Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.70|-6.13|0.9412
73993748|NCT00945672|147533682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|4.223||0.7486|TWO_SIDED|90.0|-8.38|5.66|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||5.66|-8.38|0.7486
73993749|NCT00945672|147533682|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|8.18|STANDARD_ERROR_OF_MEAN|4.171||0.0534|TWO_SIDED|90.0|1.24|15.12|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||15.12|1.24|0.0534
73993750|NCT00945672|147533682|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|3.776||0.998|TWO_SIDED|90.0|-6.29|6.31|||Mixed Models Analysis|||Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.31|-6.29|0.9980
73993751|NCT00945672|147533682|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|3.35|STANDARD_ERROR_OF_MEAN|3.958||0.4004|TWO_SIDED|90.0|-3.25|9.94|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||9.94|-3.25|0.4004
73993752|NCT00945672|147533682|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|1.81|STANDARD_ERROR_OF_MEAN|4.214||0.6685|TWO_SIDED|90.0|-5.2|8.82|||Mixed Models Analysis|||Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||8.82|-5.20|0.6685
73993753|NCT00945672|147533682|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|4.74|STANDARD_ERROR_OF_MEAN|4.522||0.2968|TWO_SIDED|90.0|-2.77|12.25|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.25|-2.77|0.2968
73993754|NCT00945672|147533682|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|4.494||0.772|TWO_SIDED|90.0|-8.77|6.16|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.16|-8.77|0.7720
73993755|NCT00945672|147533683|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.789||0.8205|TWO_SIDED|90.0|-12.68|16.69|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||16.69|-12.68|0.8205
73993756|NCT00945672|147533683|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.37|STANDARD_ERROR_OF_MEAN|8.789||0.2007|TWO_SIDED|90.0|-3.31|26.06|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||26.06|-3.31|0.2007
73993757|NCT00945672|147533683|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|8.9|STANDARD_ERROR_OF_MEAN|0.8789||0.3152|TWO_SIDED|90.0|-5.78|23.59|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||23.59|-5.78|0.3152
73993758|NCT00945672|147533683|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|8.964||0.8071|TWO_SIDED|90.0|-17.18|12.79|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.79|-17.18|0.8071
73993759|NCT00945672|147533683|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|9.354||0.9918|TWO_SIDED|90.0|-15.72|15.52|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||15.52|-15.72|0.9918
73993760|NCT00945672|147533683|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.01|STANDARD_ERROR_OF_MEAN|9.415||0.7498|TWO_SIDED|90.0|-18.73|12.7|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.70|-18.73|0.7498
73876684|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.7||||0.72|TWO_SIDED|95.0|-23.8|12.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||12.3|-23.8|0.720
73993761|NCT00945672|147533684|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|1.91||0.4855|TWO_SIDED|90.0|-1.9|4.6|||ANCOVA|||Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.||4.60|-1.90|0.4855
73993762|NCT00945672|147533684|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.45|STANDARD_ERROR_OF_MEAN|2.185||0.5132|TWO_SIDED|90.0|-2.27|5.16|||ANCOVA|||Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.||5.16|-2.27|0.5132
73993763|NCT01150461|147533728|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test||||0.02
73993764|NCT01150461|147533729|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test||||0.06
73993765|NCT01681992|147533730|NON_INFERIORITY|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-5.48|||||TWO_SIDED|97.5|-7.65|-3.43|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.||-3.43|-7.65|
73993766|NCT01681992|147533730|NON_INFERIORITY|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-2.08|||||TWO_SIDED|97.5|-3.96|-0.27|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.||-0.27|-3.96|
73993767|NCT01681992|147533731|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.42|||||TWO_SIDED|97.5|-1.91|1.04|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||1.04|-1.91|
73993768|NCT01681992|147533731|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.58|||||TWO_SIDED|97.5|-2.11|0.91|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||0.91|-2.11|
73993769|NCT01681992|147533732|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-9.41|||||TWO_SIDED|97.5|-13.2|-5.62|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||-5.62|-13.20|
73993770|NCT01681992|147533732|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-7.22|||||TWO_SIDED|97.5|-10.94|-3.49|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||-3.49|-10.94|
73993771|NCT01681992|147533733|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.71|||||TWO_SIDED|97.5|-3.11|-0.42|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.||-0.42|-3.11|
73993772|NCT01681992|147533733|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.18|||||TWO_SIDED|97.5|-2.5|0.05|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.||0.05|-2.50|
73993773|NCT01681992|147533734|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.79|||||TWO_SIDED|97.5|0.72|0.88|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.||0.88|0.72|
74035707|NCT04047121|147623977|SUPERIORITY||Odds Ratio (OR)|0.0233||||0.5899|TWO_SIDED|95.0|-0.0615|0.1082|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1082|-0.0615|0.5899
74035708|NCT04047121|147623978|SUPERIORITY|||||||0.4133|||||||t-test, 2 sided|||||||0.4133
74035709|NCT04047121|147623978|SUPERIORITY|||||||0.7171|||||||t-test, 2 sided|||||||0.7171
74035710|NCT04047121|147623978|SUPERIORITY|||||||0.8609|||||||t-test, 2 sided|||||||0.8609
74035711|NCT04047121|147623978|SUPERIORITY||Odds Ratio (OR)|-0.0445||||0.6224|TWO_SIDED|95.0|-0.2218|0.1327|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1327|-0.2218|0.6224
74035712|NCT04047121|147623978|SUPERIORITY||Odds Ratio (OR)|-0.0884||||0.5655|TWO_SIDED|95.0|-0.39|0.2132|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.2132|-0.3900|0.5655
73993774|NCT01681992|147533734|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.91|||||TWO_SIDED|97.5|0.83|1.01|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.||1.01|0.83|
73993775|NCT01681992|147533735|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.82|||||TWO_SIDED|97.5|0.76|0.89|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.89|0.76|
73993776|NCT01681992|147533735|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.84|||||TWO_SIDED|97.5|0.78|0.91|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.91|0.78|
73993777|NCT01681992|147533736|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.6|||||TWO_SIDED|97.5|0.53|0.68|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.68|0.53|
73993778|NCT01681992|147533736|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.65|||||TWO_SIDED|97.5|0.57|0.74|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.74|0.57|
73993779|NCT01681992|147533737|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.89|||||TWO_SIDED|97.5|0.83|0.95|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.||0.95|0.83|
73993780|NCT01681992|147533737|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.88|||||TWO_SIDED|97.5|0.83|0.95|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.||0.95|0.83|
73993781|NCT01028677|147533758|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 1 sided|||Analysis of fear emotion||||.61
73993782|NCT01028677|147533759|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||Positive Symptoms||||0.008
74035713|NCT04047121|147623978|SUPERIORITY||Odds Ratio (OR)|0.1809||||0.4044|TWO_SIDED|95.0|-0.2444|0.6062|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.6062|-0.2444|0.4044
73993783|NCT01028677|147533759|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Negative Symptoms||||0.002
73993784|NCT01028677|147533759|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||General Symptoms||||0.04
73993785|NCT01028677|147533759|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Positive Symptoms||||0.05
73993786|NCT01028677|147533759|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Negative Symptoms||||0.08
73993787|NCT01028677|147533759|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||General Symptoms||||0.025
73993788|NCT01028677|147533761|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.03
73993789|NCT01028677|147533763|SUPERIORITY_OR_OTHER|||||||0.784|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||IRI-total||||.784
73993790|NCT01028677|147533763|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||Distress analysis||||1.00
73993791|NCT01028677|147533763|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||Perspective-Taking||||.03
73993792|NCT01028677|147533763|SUPERIORITY_OR_OTHER|||||||0.135|||||||t-test, 2 sided|||Emotional empathy analysis||||.135
73993793|NCT01028677|147533763|SUPERIORITY_OR_OTHER|||||||0.681|TWO_SIDED||||||t-test, 2 sided|||Fantasy Analysis||||.681
73993794|NCT01028677|147533763|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||Distress analysis||||1.00
74035714|NCT04047121|147623979|SUPERIORITY|||||||0.0104|||||||t-test, 2 sided|||||||0.0104
74035715|NCT04047121|147623979|SUPERIORITY|||||||0.5949|||||||t-test, 2 sided|||||||0.5949
74035716|NCT04047121|147623979|SUPERIORITY|||||||0.0801|||||||t-test, 2 sided|||||||0.0801
74035717|NCT04047121|147623979|SUPERIORITY||Odds Ratio (OR)|-3.7075||||0.0072|TWO_SIDED|95.0|-6.411|-1.004|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||-1.0040|-6.4110|0.0072
74039710|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1736|TWO_SIDED|95.0|0.93|1.54|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.54|0.93|0.1736
73876685|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-7.9||||0.683|TWO_SIDED|95.0|-27.2|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||11.5|-27.2|0.683
73876686|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|23.0||||0.215|TWO_SIDED|95.0|-12.8|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||58.9|-12.8|0.215
73876687|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-12.3||||0.279|TWO_SIDED|95.0|-30.4|5.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||5.8|-30.4|0.279
73993795|NCT04148989|147533812|SUPERIORITY||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-18.6|-7.0|||Regression, gamma||Change in emergency department door-to-antibiotic time (minutes) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||-7.0|-18.6|<0.001
73993796|NCT04148989|147533813|SUPERIORITY||Odds Ratio (OR)|0.89||||0.45|TWO_SIDED|95.0|0.68|1.19|||Regression, Logistic||Change in all-cause 30-day mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.19|0.68|0.45
73993797|NCT04148989|147533814|SUPERIORITY||Odds Ratio (OR)|0.83||||0.1|TWO_SIDED|95.0|0.67|1.04|||Regression, Logistic||Change in all-cause 1-year mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.04|0.67|0.10
73993798|NCT04148989|147533815|SUPERIORITY||Odds Ratio (OR)|0.77||||0.15|TWO_SIDED|95.0|0.53|1.1|||Regression, Logistic|||Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Change in all-cause in-hospital mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|1.10|0.53|0.15
73993799|NCT04148989|147533816|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.71|TWO_SIDED|95.0|-1.4|2.1|||Regression, gamma||Change in hospital charges ($1000s) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||2.1|-1.4|0.71
74035718|NCT04047121|147623979|SUPERIORITY||Odds Ratio (OR)|-1.4296||||0.5406|TWO_SIDED|95.0|-6.008|3.1489|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.1489|-6.0080|0.5406
74035719|NCT04047121|147623979|SUPERIORITY||Odds Ratio (OR)|-0.3527||||0.8603|TWO_SIDED|95.0|-4.279|3.5737|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.5737|-4.2790|0.8603
74035720|NCT04047121|147623980|SUPERIORITY|||||||0.6344|||||||t-test, 2 sided|||||||0.6344
74035721|NCT04047121|147623980|SUPERIORITY|||||||0.3037|||||||t-test, 2 sided|||||||0.3037
74035722|NCT04047121|147623980|SUPERIORITY|||||||0.1344|||||||t-test, 2 sided|||||||0.1344
74035723|NCT04047121|147623980|SUPERIORITY||Odds Ratio (OR)|1.2586||||0.5092|TWO_SIDED|95.0|-2.4787|4.9958|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.9958|-2.4787|0.5092
74035724|NCT04047121|147623980|SUPERIORITY||Odds Ratio (OR)|-0.7696||||0.8047|TWO_SIDED|95.0|-6.8683|5.3292|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.3292|-6.8683|0.8047
73876688|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-6.4||||0.716|TWO_SIDED|95.0|-28.2|15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||15.4|-28.2|0.716
73876689|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-3.2||||1|TWO_SIDED|95.0|-27.5|21.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.1|-27.5|1.000
73876690|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-8.2||||0.4|TWO_SIDED|95.0|-23.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||7.1|-23.5|0.400
73993800|NCT04148989|147533817|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.19|TWO_SIDED|95.0|-0.4|0.1|||Regression, gamma||Change in hospital length of stay (days) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||0.1|-0.4|0.19
73993801|NCT04148989|147533818|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.1||||0.005|TWO_SIDED|95.0|1.03|1.17||Model adjusted for age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Regression, Logistic||Change in antimicrobial treatment risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||1.17|1.03|0.005
73993802|NCT04148989|147533819|SUPERIORITY||Odds Ratio (OR)|1.09||||0.73|TWO_SIDED|95.0|0.68|1.75|||Regression, Logistic||Change in risk for possible antimicrobial-associated adverse event associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.75|0.68|0.73
73993803|NCT04148989|147533820|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.02||||0.9|TWO_SIDED|95.0|0.78|1.33||Model adjusted for age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Regression, Logistic|||Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.|Change in risk for possible antimicrobial-associated adverse event associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|1.33|0.78|0.90
73993804|NCT04148989|147533821|SUPERIORITY||Odds Ratio (OR)|1.03||||0.94|TWO_SIDED|95.0|0.49|2.17|||Regression, Logistic||Change in new-onset Clostridium difficile colitis risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||2.17|0.49|0.94
73993805|NCT04148989|147533822|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.41||||0.1|TWO_SIDED|95.0|0.93|2.14|||Regression, Logistic||Change in new-onset Clostridium difficile colitis risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||2.14|0.93|0.10
73993806|NCT04148989|147533823|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.1% of eligible patients.|Odds Ratio (OR)|1.15||||0.59|TWO_SIDED|95.0|0.69|1.93|||Regression, Logistic||Change in risk for antimicrobial administration in the ED associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||1.93|0.69|0.59
74035725|NCT04047121|147623980|SUPERIORITY||Odds Ratio (OR)|0.094||||0.9757|TWO_SIDED|95.0|-5.9628|6.1507|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.1507|-5.9628|0.9757
74035726|NCT04047121|147623981|SUPERIORITY|||||||0.0839|||||||t-test, 2 sided|||||||0.0839
74035727|NCT04047121|147623981|SUPERIORITY|||||||0.9577|||||||t-test, 2 sided|||||||0.9577
74035728|NCT04047121|147623981|SUPERIORITY|||||||0.9497|||||||t-test, 2 sided|||||||0.9497
74035729|NCT04047121|147623981|SUPERIORITY||Odds Ratio (OR)|-0.031||||0.4873|TWO_SIDED|95.0|-0.1185|0.0565|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0565|-0.1185|0.4873
73993807|NCT04148989|147533824|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.02|TWO_SIDED|95.0|0.06|0.58|||Regression, Linear||Change in total spectrum score of antibiotics administered within 24 hours of ED arrival associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable ??? regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||0.58|0.06|0.02
73993808|NCT04148989|147533825|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 2.0% of eligible patients.|Mean Difference (Final Values)|0.17||||0.02|TWO_SIDED|95.0|0.03|0.31|||Regression, Linear||Change in total spectrum score of antibiotics administered within 24 hours of ED arrival associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable linear regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||0.31|0.03|0.02
73993809|NCT03812029|147533826|SUPERIORITY|||||||0.0015||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0015
73993810|NCT03812029|147533826|SUPERIORITY|||||||0.0121||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0121
73993811|NCT03812029|147533826|SUPERIORITY|||||||0.0371||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0371
73993812|NCT03812029|147533827|SUPERIORITY|||||||0.003||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.003
73993813|NCT03812029|147533827|SUPERIORITY|||||||0.04||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.04
73993814|NCT03812029|147533828|SUPERIORITY|||||||0.0017||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0017
73993815|NCT03812029|147533828|SUPERIORITY|||||||0.018||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.018
73993816|NCT03812029|147533828|SUPERIORITY|||||||0.13||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.13
73993817|NCT03812029|147533829|SUPERIORITY|||||||0.001||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.001
73993818|NCT03812029|147533829|SUPERIORITY|||||||0.002||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.002
73993819|NCT03812029|147533829|SUPERIORITY|||||||0.018||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.018
73993820|NCT03812029|147533830|SUPERIORITY|||||||0.09||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.09
73993821|NCT03812029|147533830|SUPERIORITY|||||||0.47||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.47
73993822|NCT03812029|147533830|SUPERIORITY|||||||0.14||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.14
73993823|NCT03812029|147533831|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||<0.0001
73993824|NCT03812029|147533831|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||<0.0001
73993825|NCT03812029|147533831|SUPERIORITY|||||||0.0002||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0002
73993826|NCT03812029|147533832|SUPERIORITY|||||||0.017||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.017
73993827|NCT03812029|147533832|SUPERIORITY|||||||0.0006||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0006
74035730|NCT04047121|147623981|SUPERIORITY||Odds Ratio (OR)|-0.0312||||0.678|TWO_SIDED|95.0|-0.1783|0.1159|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1159|-0.1783|0.6780
73993828|NCT03812029|147533832|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.006
73993829|NCT03812029|147533833|SUPERIORITY|||||||0.16||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.16
73993830|NCT03812029|147533833|SUPERIORITY|||||||0.01||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.01
73993831|NCT03812029|147533833|SUPERIORITY|||||||0.57||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.57
73993832|NCT03812029|147533834|SUPERIORITY|||||||0.0017||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0017
73993833|NCT03812029|147533834|SUPERIORITY|||||||0.0093||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0093
73993834|NCT03355209|147533894|SUPERIORITY||Median Difference (A-P)|-19.88||||0.0008|TWO_SIDED|95.0|-31.02|-8.74|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann (HL) method|||-8.74|-31.02|0.0008
73993835|NCT03355209|147533897|SUPERIORITY||Median Difference (A-P)|-10.5||||0.146|TWO_SIDED|95.0|-24.99|3.99|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann (HL) method|||3.99|-24.99|0.1460
73993836|NCT03355209|147533898|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0051|TWO_SIDED|95.0|1.43|7.59|||Regression, Logistic|||||7.59|1.43|0.0051
73993837|NCT03355209|147533898|SUPERIORITY||Odds Ratio (OR)|2.87||||0.015|TWO_SIDED|95.0|1.23|6.7|||Regression, Logistic|||||6.70|1.23|0.0150
73993838|NCT03355209|147533899|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1565|TWO_SIDED|95.0|0.84|2.97|||Cochran-Mantel-Haenszel|||Visit 12||2.97|0.84|0.1565
73993839|NCT03355209|147533899|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0567|TWO_SIDED|95.0|0.98|3.52|||Cochran-Mantel-Haenszel|||Visit 12||3.52|0.98|0.0567
73993840|NCT01825577|147534014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||.55
73993841|NCT01825577|147534015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.67|TWO_SIDED||||||t-test, 2 sided|||||||.67
73993842|NCT00358644|147534016|SUPERIORITY_OR_OTHER||Percentage of Participants|23.6||||||95.0|13.2|37.0||||||||37.0|13.2|
73993843|NCT03332784|147534059|SUPERIORITY||||||<|0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||<0.0001
73876691|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|0.7||||1|TWO_SIDED|95.0|-19.6|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.0|-19.6|1.000
73876692|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|7.9||||0.62|TWO_SIDED|95.0|-22.2|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||38.0|-22.2|0.620
73876693|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-8.2||||0.4|TWO_SIDED|95.0|-23.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||7.1|-23.5|0.400
73876694|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-4.3||||1|TWO_SIDED|95.0|-22.7|14.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.2|-22.7|1.000
73876695|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|4.0||||1|TWO_SIDED|95.0|-18.7|26.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||26.6|-18.7|1.000
73876696|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|5.0||||0.678|TWO_SIDED|95.0|-9.7|19.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||19.6|-9.7|0.678
73876697|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|7.9||||0.636|TWO_SIDED|95.0|-10.5|26.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||26.2|-10.5|0.636
73876698|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|21.4||||0.19|TWO_SIDED|95.0|-9.7|52.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||52.5|-9.7|0.190
73876699|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|9.0||||0.504|TWO_SIDED|95.0|-17.3|35.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||35.3|-17.3|0.504
73876700|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|1.6||||0.916|TWO_SIDED|95.0|-27.8|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||31.0|-27.8|0.916
73993844|NCT03332784|147534059|SUPERIORITY||||||<|0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||<0.0001
73876701|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-31.7|31.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||31.7|-31.7|1.000
73993845|NCT03332784|147534059|SUPERIORITY|||||||0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||0.0001
73876702|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-9.0||||0.504|TWO_SIDED|95.0|-35.3|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||17.3|-35.3|0.504
73993846|NCT00401258|147534060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
73993847|NCT00401258|147534061|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Average pain severity statistical analysis||||<.001
73993848|NCT00401258|147534061|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Average pain interference statistical analysis||||<.001
73993849|NCT00401258|147534062|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||.001
73993850|NCT00401258|147534063|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73993851|NCT00401258|147534065|SUPERIORITY_OR_OTHER|||||||0.031|||||||Mixed Models Analysis|||||||0.031
73993852|NCT00401258|147534066|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73993853|NCT00401258|147534067|SUPERIORITY_OR_OTHER|||||||0.004||||||Refers to work/school sub-scale|Mixed Models Analysis|||||||0.004
73993854|NCT00401258|147534067|SUPERIORITY_OR_OTHER|||||||0.087||||||Refers to social sub scale|Mixed Models Analysis|||||||0.087
73876703|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-7.1||||0.635|TWO_SIDED|95.0|-36.6|22.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||22.3|-36.6|0.635
73876704|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|10.7||||0.513|TWO_SIDED|95.0|-21.1|42.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||42.5|-21.1|0.513
73876705|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|1.7||||0.898|TWO_SIDED|95.0|-24.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||28.1|-24.7|0.898
73876706|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-13.1||||0.379|TWO_SIDED|95.0|-41.7|15.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||15.5|-41.7|0.379
73876707|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-3.6||||0.822|TWO_SIDED|95.0|-34.5|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||27.4|-34.5|0.822
73876708|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|8.9||||0.508|TWO_SIDED|95.0|-17.3|35.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||35.0|-17.3|0.508
73876709|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-6.0||||0.683|TWO_SIDED|95.0|-34.3|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||22.4|-34.3|0.683
73876710|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|14.3||||0.49|TWO_SIDED|95.0|-16.6|45.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||45.1|-16.6|0.490
73876711|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|23.3||||0.078|TWO_SIDED|95.0|-1.9|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||48.5|-1.9|0.078
73876712|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|10.3||||0.466|TWO_SIDED|95.0|-17.7|38.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||38.4|-17.7|0.466
73876713|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|1.000
73876714|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|0.447
73876715|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|1.000
73876716|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-11.8||||1|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|1.000
73876717|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-11.8||||0.193|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|0.193
73993855|NCT00401258|147534067|SUPERIORITY_OR_OTHER|||||||0.006||||||Refers to family sub scale|Mixed Models Analysis|||||||0.006
73876718|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-11.8||||0.498|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|0.498
73876719|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|1.000
73876720|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|0.447
73876721|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|1.000
73993856|NCT01430468|147534068|EQUIVALENCE|With use of previously established criteria for a malpositioned glenoid, deviations of greater than 10 degrees of version from the planned placement were considered relevant.||||||0.11||||||P-value was calculated. Threshold for statistical significance (p\<0.05)|t-test, 2 sided|||The absolute difference between the actual outcome and the planned outcome was compared between the standard surgical group and the glenoid positioning system group with use of a Student t test. Results were considered to be significant at p \< 0.05.||||0.11
73993857|NCT05672771|147534070|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.355|TWO_SIDED||||||ANOVA|||||||0.355
73993858|NCT05672771|147534071|SUPERIORITY||Mean Difference (Final Values)|0.56|||<|0.02|TWO_SIDED||||||ANOVA||This is the difference between the Different Mixed and Placebo Control conditions.|||||<.02
73993859|NCT05672771|147534072|OTHER||||||<|0.05||||||for contrasts of DM, DS, and ST groups relative to the PC group.|Mixed Models Analysis|||||||<.05
73993860|NCT00760747|147534073|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|-0.7|STANDARD_ERROR_OF_MEAN|1.7||0.692|TWO_SIDED|95.0|-4.0|2.6|||Mixed Models Analysis|||||2.6|-4.0|0.692
73993861|NCT00760747|147534074|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.456|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|0.456
73993862|NCT00760747|147534075|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.517|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|0.517
73993863|NCT00760747|147534076|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.526|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||||0.6|-0.3|0.526
73993864|NCT00760747|147534077|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.898|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|||||0.4|-0.4|0.898
73993865|NCT00760747|147534082|SUPERIORITY_OR_OTHER||Least square mean differences at week 2|-0.1|STANDARD_ERROR_OF_MEAN|1.4||0.927|TWO_SIDED|95.0|-2.9|2.6|||Mixed Models Analysis|||||2.6|-2.9|0.927
73993866|NCT00455741|147534122|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||effect of age on estrogen negative feedback ( nadir LH as % of baseline LH)||||0.90
73993867|NCT00455741|147534122|SUPERIORITY||||||<|0.03||||||a priori threshold for significance is p\<0.05|ANOVA|||positive feedback||||<0.03
73993868|NCT00455741|147534123|SUPERIORITY||||||=|0.03||||||a priori significance level p\<0.05|ANOVA|||||||=0.03
73993869|NCT00455741|147534124|SUPERIORITY|||||||0.49||||||threshold for significance p\<0.05|t-test, 2 sided|||||||0.49
74035731|NCT04047121|147623981|SUPERIORITY||Odds Ratio (OR)|0.0099||||0.9327|TWO_SIDED|95.0|-0.2207|0.2406|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.2406|-0.2207|0.9327
74035732|NCT04047121|147623982|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
74035733|NCT04047121|147623982|SUPERIORITY|||||||0.5396|||||||t-test, 2 sided|||||||0.5396
73993870|NCT00455741|147534125|SUPERIORITY||||||<|0.02||||||a priori threshold for significance p\<0.05|t-test, 2 sided|||||||<0.02
73993871|NCT00455741|147534126|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
73993872|NCT00455741|147534127|SUPERIORITY|||||||0.07||||||a priori significance set at p\<0.05|t-test, 2 sided|||||||0.07
74009273|NCT04667377|147569396|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Exponential model fit|Model Assumption: 50% of maximum effect achieved at dose 3.6 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
74035734|NCT04047121|147623982|SUPERIORITY|||||||0.6121|||||||t-test, 2 sided|||||||0.6121
74035735|NCT04047121|147623982|SUPERIORITY||Odds Ratio (OR)|-0.1895||||0.0303|TWO_SIDED|95.0|-0.361|-0.0181|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||-0.0181|-0.3610|0.0303
73876722|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|1.000
73876723|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|0.447
73876724|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|1.000
73876725|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||5.3|-17.1|1.000
73876726|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-1.1||||1|TWO_SIDED|95.0|-15.5|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||13.3|-15.5|1.000
73876727|NCT02365649|147294842|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||5.3|-17.1|1.000
73876728|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-57.2|43.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||43.9|-57.2|1.000
73876729|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||55.8|-9.2|0.323
73876730|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|33.3||||0.516|TWO_SIDED|95.0|6.7|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||60.0|6.7|0.516
73876731|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-31.7||||0.191|TWO_SIDED|95.0|-77.4|14.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||14.0|-77.4|0.191
73876732|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-26.0|22.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||22.6|-26.0|1.000
73876733|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-7.3|24.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||24.0|-7.3|1.000
73876734|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|33.3||||0.261|TWO_SIDED|95.0|6.7|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||60.0|6.7|0.261
73876735|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||55.8|-9.2|0.323
73876736|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-41.8|58.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||58.5|-41.8|1.000
73876737|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-26.7||||0.593|TWO_SIDED|95.0|-77.2|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||23.9|-77.2|0.593
73993873|NCT00935532|147534171|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of exenatide QW to insulin glargine with respect to change in HbA1c was to be concluded if the upper limit of the 95% confidence interval (CI) for the treatment difference was less than 0.4%. Change in HbA1c from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, baseline HbA1c stratum (\<8.5%, \>=8.5%), background OAD, and presence/absence of pretreatment with SU as factors and baseline HbA1c as a covariate.|Least Squares Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.59|-0.26||No adjustments for multiplicity will be performed|ANCOVA|||The expected changes in HbA1c from baseline were considered to be the same between the groups, and the common standard deviation assumed to be 1.2%. Assuming a type I error of 0.025 (one-sided), a power of 0.9 and a noninferiority margin of 0.4%, 191 subjects per group would be necessary to confirm the noninferiority by the two-sample t-test. When the proportion of the subjects missing post-baseline data was assumed to be 10%, the target number of subjects were 420 in total (210 subjects/group).||-0.26|-0.59|<.001
74090123|NCT03265288|147733468|SUPERIORITY||Risk Ratio (RR)|1.35||||0.1909|TWO_SIDED|95.0|0.86|2.12||alpha is set to 0.05|Poisson regression||Odds ratio \< 1 means lower odds of an antibiotic treatment with LAU-7b, odds ratio \> 1 means higher odds of an antibiotic treatment with LAU-7b|Number per subject of intravenous antibiotic treatments required for a pulmonary exacerbation, excludes Cycle 1 pulmonary exacerbations Intent to treat population (ITT), null hypothesis is no treatment effect||2.12|0.86|0.1909
73876738|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.8|-9.2|0.323
73876739|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-41.8|58.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||58.5|-41.8|1.000
73876740|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|21.7||||0.6|TWO_SIDED|95.0|-23.1|66.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||66.5|-23.1|0.600
73993874|NCT00935532|147534172|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c\<=7% at endpoint were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.||||<.001
73993875|NCT00935532|147534173|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c\<=6.5% at endpoint were compared between treatments using a CMH test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.||||<.001
73993876|NCT00935532|147534174|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.28|STANDARD_ERROR_OF_MEAN|3.23||0.103|TWO_SIDED|95.0|-11.62|1.07|||ANCOVA|||Change in FSG from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline FSG as a covariate.||1.07|-11.62|0.103
73993877|NCT00935532|147534175|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.46|-1.56|||ANCOVA|||Change in body weight from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline body weight as a covariate.||-1.56|-2.46|<.001
73993878|NCT00935532|147534176|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-12.33|-3.45|||ANCOVA|||Change in total cholesterol from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline total cholesterol as a covariate.||-3.45|-12.33|<.001
73993879|NCT00935532|147534177|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.69||0.689|TWO_SIDED|95.0|-1.64|1.09|||ANCOVA|||Change in HDL-C from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pre-treatment with SU as factors and baseline HDL-C as a covariate.||1.09|-1.64|0.689
73993880|NCT00935532|147534178|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|1.03||0.99|TWO_SIDED|95.0|0.94|1.06|||ANCOVA|||Triglycerides data were logarithm-transformed and the change at endpoint to baseline, expressed as the ratio, was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline triglycerides as a covariate.||1.06|0.94|0.990
73993881|NCT04954326|147534182|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for AUCinf should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|102.8||||0.05|TWO_SIDED|90.0|91.4|115.6|||ANOVA|||AUCinf was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||115.6|91.4|0.05
73993882|NCT04954326|147534183|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for Cmax should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|93.5||||0.05|TWO_SIDED|90.0|82.9|105.5|||ANOVA|||Cmax was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||105.5|82.9|0.05
73876741|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|31.7||||0.162|TWO_SIDED|95.0|-1.9|65.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||65.2|-1.9|0.162
73876742|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-34.1|67.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||67.4|-34.1|1.000
73876743|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-50.5|77.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||77.2|-50.5|1.000
73876744|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-100.0|1.000
73876745|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
73876746|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-40.0||||0.464|TWO_SIDED|95.0|-82.9|2.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||2.9|-82.9|0.464
73876747|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-50.0||||0.4|TWO_SIDED|95.0|-100.0|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||19.3|-100.0|0.400
73993883|NCT04954326|147534184|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for Cday14 should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|121.5||||0.05|TWO_SIDED|90.0|98.7|149.6|||ANOVA|||Cday14 was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||149.6|98.7|0.05
73993884|NCT00475228|147534187|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.05
73876748|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-46.7||||0.464|TWO_SIDED|95.0|-100.0|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||17.2|-100.0|0.464
73993885|NCT03931746|147534190|SUPERIORITY||Hodges-Lehmann median difference|-3.5||||0.04|TWO_SIDED|95.0|-8.0|-0.5|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||-0.5|-8.0|0.04
73993886|NCT03931746|147534191|SUPERIORITY||Hodges-Lehmann median difference|-2.5||||0.75|TWO_SIDED|95.0|-9.0|12.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft minus No Porcine Xenograft.|||12|-9|0.75
73876749|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||70.8|-100.0|1.000
73876750|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||86.7|-20.0|1.000
73876751|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-26.7||||1|TWO_SIDED|95.0|-95.1|41.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||41.8|-95.1|1.000
73876752|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||70.8|-100.0|1.000
74035736|NCT04047121|147623982|SUPERIORITY||Odds Ratio (OR)|-0.1901||||0.1807|TWO_SIDED|95.0|-0.4685|0.0883|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0883|-0.4685|0.1807
74035737|NCT04047121|147623982|SUPERIORITY||Odds Ratio (OR)|0.1594||||0.7445|TWO_SIDED|95.0|-0.7991|1.1178|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1178|-0.7991|0.7445
73876753|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||86.7|-20.0|1.000
73876754|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-77.2|50.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||50.5|-77.2|1.000
73876755|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-70.8|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|-70.8|1.000
73993887|NCT03931746|147534192|SUPERIORITY||Hodges-Lehmann median difference|1.0||||1|TWO_SIDED|95.0|-19.0|20.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||20.0|-19.0|1
73993888|NCT03931746|147534193|SUPERIORITY||Hodges-Lehmann median difference|0.01||||1|TWO_SIDED|95.0|-0.26|0.33|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft vs. No Porcine Xenograft.|||0.33|-0.26|1
74035738|NCT04047121|147623983|SUPERIORITY|||||||0.0035|||||||t-test, 2 sided|||||||0.0035
73876756|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|66.7||||1|TWO_SIDED|95.0|13.3|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|13.3|1.000
73876757|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-33.8|40.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||40.4|-33.8|1.000
73993889|NCT03931746|147534194|SUPERIORITY||Hodges-Lehmann median difference|0.0||||1|TWO_SIDED|95.0|-6.0|4.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||4|-6|1
73993890|NCT03931746|147534195|SUPERIORITY||Hodges-Lehmann median difference|0.5||||0.54|TWO_SIDED|95.0|-1.0|2.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||2|-1|0.54
74035739|NCT04047121|147623983|SUPERIORITY|||||||0.504|||||||t-test, 2 sided|||||||0.5040
74035740|NCT04047121|147623983|SUPERIORITY|||||||0.1366|||||||t-test, 2 sided|||||||0.1366
74035741|NCT04047121|147623983|SUPERIORITY||Odds Ratio (OR)|-3.4084||||0.082|TWO_SIDED|95.0|-7.2497|0.433|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.4330|-7.2497|0.0820
74035742|NCT04047121|147623983|SUPERIORITY||Odds Ratio (OR)|-1.5342||||0.5845|TWO_SIDED|95.0|-7.0336|3.9652|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.9652|-7.0336|0.5845
74035743|NCT04047121|147623983|SUPERIORITY||Odds Ratio (OR)|0.987||||0.7284|TWO_SIDED|95.0|-4.583|6.557|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.5570|-4.5830|0.7284
74035744|NCT04047121|147623984|SUPERIORITY|||||||0.1125|||||||t-test, 2 sided|||||||0.1125
74035745|NCT04047121|147623984|SUPERIORITY|||||||0.7156|||||||t-test, 2 sided|||||||0.7156
74035746|NCT04047121|147623984|SUPERIORITY|||||||0.2056|||||||t-test, 2 sided|||||||0.2056
74035747|NCT04047121|147623984|SUPERIORITY||Odds Ratio (OR)|-1.8061||||0.4288|TWO_SIDED|95.0|-6.2797|2.6675|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.6675|-6.2797|0.4288
74035748|NCT04047121|147623984|SUPERIORITY||Odds Ratio (OR)|-1.6946||||0.6303|TWO_SIDED|95.0|-8.5962|5.2069|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.2069|-8.5962|0.6303
74035749|NCT04047121|147623984|SUPERIORITY||Odds Ratio (OR)|-0.9873||||0.7477|TWO_SIDED|95.0|-7.0028|5.0281|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.0281|-7.0028|0.7477
74035750|NCT04047121|147623985|SUPERIORITY|||||||0.3919|||||||t-test, 2 sided|||||||0.3919
74090124|NCT03265288|147733469|SUPERIORITY||Risk Ratio (RR)|1.11||||0.7473|TWO_SIDED|95.0|0.6|2.04||alpha is set to 0.05|Poisson regression||Odds ratio \< 1 means lower odds in terms of days of antibiotics with LAU-7b, odds ratio close to 1 means similar odds in terms of days of antibiotics with LAU-7b or placebo, odds ratio \> 1 means higher odds in terms of days of antibiotics with LAU-7b|Number of days of intravenous antibiotics required for a pulmonary exacerbation, excludes Cycle 1 pulmonary exacerbations, Intent to treat population (ITT), null hypothesis is no treatment effect||2.04|0.60|0.7473
74090125|NCT03265288|147733470|SUPERIORITY||Least Squares Means difference|-2.89||||0.0822|TWO_SIDED|95.0|-6.154|0.374||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|C-Reactive Protein (CRP), Intent-to-Treat population (ITT), null hypothesis is no treatment effect||0.374|-6.154|0.0822
73993891|NCT03931746|147534196|SUPERIORITY||Odds Ratio (OR)|0.69||||1|TWO_SIDED|95.0|0.03|13.3|||Fisher Exact||"The No Porcine Xenograft group is the reference group."|||13.3|0.03|1
73993892|NCT03931746|147534197|SUPERIORITY||Risk Difference (RD)|-0.167||||0.43|TWO_SIDED|95.0|-0.564|0.185|||Fisher Exact||"The risk difference is calculated as the outcome risk in the Porcine Xenograft group minus the outcome risk in the No Porcine Xenograft group. The confidence interval for the risk difference was calculated using the Newcombe hybrid score method."|||0.185|-0.564|0.43
73993893|NCT03931746|147534198|SUPERIORITY||Odds Ratio (OR)|0.6||||1|TWO_SIDED|95.0|0.006|55.9|||Fisher Exact||"The No Porcine Xenograft group is the reference group."|||55.9|0.006|1
73993894|NCT01183390|147534202|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.6|||||TWO_SIDED|90.0|95.1|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.28|95.10|
73993895|NCT01183390|147534203|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||TWO_SIDED|90.0|96.99|101.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.80|96.99|
73993896|NCT02358668|147534204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.46||||0.57|TWO_SIDED|95.0|-6.28|11.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||11.20|-6.28|0.57
73993897|NCT02358668|147534204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.57||||0.72|TWO_SIDED|95.0|-10.3|7.11||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||7.11|-10.3|0.72
73993898|NCT02358668|147534205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.66|TWO_SIDED|95.0|-0.91|1.42||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.42|-0.91|0.66
73993899|NCT02358668|147534205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.9|TWO_SIDED|95.0|-1.03|1.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.18|-1.03|0.90
73993900|NCT02358668|147534206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.86|TWO_SIDED|95.0|-0.5|0.59||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.59|-0.50|0.86
73993901|NCT02358668|147534206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.59|TWO_SIDED|95.0|-0.66|0.38||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.38|-0.66|0.59
73993902|NCT02358668|147534207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.62|TWO_SIDED|95.0|-0.44|0.73||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.73|-0.44|0.62
73993903|NCT02358668|147534207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.97|TWO_SIDED|95.0|-0.52|0.55||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.55|-0.52|0.97
73993904|NCT02358668|147534208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.4|TWO_SIDED|95.0|-0.2|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.51|-0.20|0.40
73993905|NCT02358668|147534208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.49|TWO_SIDED|95.0|-0.21|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.44|-0.21|0.49
73993906|NCT02358668|147534209|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84||||0.41|TWO_SIDED|95.0|-2.88|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.21|-2.88|0.41
73993907|NCT02358668|147534209|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.34||||0.15|TWO_SIDED|95.0|-3.18|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.51|-3.18|0.15
73993908|NCT02358668|147534210|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.64|TWO_SIDED|95.0|-0.29|0.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.18|-0.29|0.64
73993909|NCT02358668|147534210|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.41|TWO_SIDED|95.0|-0.3|0.12||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.12|-0.30|0.41
73993910|NCT02358668|147534211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.19||||0.46|TWO_SIDED|95.0|-4.43|2.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||2.05|-4.43|0.46
73993911|NCT02358668|147534211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.75||||0.24|TWO_SIDED|95.0|-4.72|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.21|-4.72|0.24
73993912|NCT02358668|147534212|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.13|0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.10|-0.13|0.83
73993913|NCT02358668|147534212|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.48|TWO_SIDED|95.0|-0.16|0.08||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.08|-0.16|0.48
73993914|NCT02358668|147534213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.14||||0.83|TWO_SIDED|95.0|-9.17|11.45||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||11.45|-9.17|0.83
73993915|NCT02358668|147534213|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92||||0.86|TWO_SIDED|95.0|-11.1|9.27||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||9.27|-11.1|0.86
73993916|NCT02358668|147534214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6||||0.75|TWO_SIDED|95.0|-99.6|72.3||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||72.3|-99.6|0.75
73993917|NCT02358668|147534214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|40.0||||0.34|TWO_SIDED|95.0|-43.9|123.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||123.9|-43.9|0.34
73993918|NCT02358668|147534215|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-980.0||||0.23|TWO_SIDED|95.0|-2604.0|643.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||643.8|-2604|0.23
73993919|NCT02358668|147534215|SUPERIORITY_OR_OTHER||Mean Difference (Net)|323.9||||0.68|TWO_SIDED|95.0|-1269.0|1916.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1916.6|-1269|0.68
73993920|NCT02358668|147534216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0||||0.79|TWO_SIDED|95.0|-99.6|129.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||129.6|-99.6|0.79
73993921|NCT02358668|147534216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|60.1||||0.29|TWO_SIDED|95.0|-52.5|172.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||172.6|-52.5|0.29
73993922|NCT02358668|147534217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-120.2||||0.37|TWO_SIDED|95.0|-385.3|144.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||144.9|-385.3|0.37
73993923|NCT02358668|147534217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0||||0.69|TWO_SIDED|95.0|-198.1|296.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||296.2|-198.1|0.69
73993924|NCT02358668|147534219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.57|TWO_SIDED|95.0|-9.8|5.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||5.5|-9.8|0.57
73993925|NCT02358668|147534219|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.79|TWO_SIDED|95.0|-6.6|8.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||8.6|-6.6|0.79
73993926|NCT02358668|147534220|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.54|TWO_SIDED|95.0|-3.4|1.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.8|-3.4|0.54
73993927|NCT02358668|147534220|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.68|TWO_SIDED|95.0|-2.0|3.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||3.1|-2.0|0.68
73993928|NCT02358668|147534221|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.03|TWO_SIDED|95.0|-3.2|-0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||-0.1|-3.2|0.03
73993929|NCT02358668|147534221|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.86|TWO_SIDED|95.0|-1.7|1.4||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.4|-1.7|0.86
73993930|NCT02358668|147534222|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.9|TWO_SIDED|95.0|-0.39|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.44|-0.39|0.90
74035751|NCT04047121|147623985|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74035752|NCT04047121|147623985|SUPERIORITY|||||||0.0193|||||||t-test, 2 sided|||||||0.0193
73993931|NCT02358668|147534222|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.3|TWO_SIDED|95.0|-0.63|0.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.20|-0.63|0.30
73993932|NCT02358668|147534223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62||||0.52|TWO_SIDED|95.0|-1.32|2.57||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||2.57|-1.32|0.52
73993933|NCT02358668|147534223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.13||||0.24|TWO_SIDED|95.0|-0.75|3.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||3.05|-0.75|0.24
73993934|NCT02358668|147534224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.002||||0.93|TWO_SIDED|95.0|-0.035|0.038||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.038|-0.035|0.93
73993935|NCT02358668|147534224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015||||0.4|TWO_SIDED|95.0|-0.021|0.051||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.051|-0.021|0.40
73993936|NCT02358668|147534225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.36|TWO_SIDED|95.0|-1.2|0.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.5|-1.2|0.36
74035753|NCT04047121|147623985|SUPERIORITY||Cost Ratio|1.2232||||0.057|TWO_SIDED|95.0|0.994|1.5053|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a generalized linear model (GLM). Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.5053|0.9940|0.0570
74035754|NCT04047121|147623985|SUPERIORITY||Cost Ratio|1.8479|||<|0.0001|TWO_SIDED|95.0|1.4378|2.3749|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3749|1.4378|<0.0001
73993937|NCT02358668|147534225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.36|TWO_SIDED|95.0|-0.4|1.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.2|-0.4|0.36
73993938|NCT02358668|147534226|SUPERIORITY_OR_OTHER|||||||0.09||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.09
73993939|NCT02358668|147534226|SUPERIORITY_OR_OTHER|||||||0.82||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.82
73993940|NCT02358668|147534227|SUPERIORITY_OR_OTHER|||||||0.68||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.68
73993941|NCT02358668|147534227|SUPERIORITY_OR_OTHER|||||||0.26||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.26
73993942|NCT02358668|147534228|SUPERIORITY_OR_OTHER|||||||0.67||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.67
73993943|NCT02358668|147534228|SUPERIORITY_OR_OTHER|||||||0.3||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.30
73993944|NCT02358668|147534229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||<|0.01|TWO_SIDED|95.0|-0.48|-0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.11|-0.48|<0.01
73993945|NCT02358668|147534229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.13|TWO_SIDED|95.0|-0.32|0.04||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.04|-0.32|0.13
73993946|NCT02358668|147534230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.01|TWO_SIDED|95.0|-1.01|-0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.18|-1.01|0.01
73993947|NCT02358668|147534230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.42|TWO_SIDED|95.0|-0.57|0.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.24|-0.57|0.42
73993948|NCT02358668|147534231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74||||0.02|TWO_SIDED|95.0|-1.35|-0.14||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.14|-1.35|0.02
73993949|NCT02358668|147534231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.57|TWO_SIDED|95.0|-0.75|0.42||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.42|-0.75|0.57
74035755|NCT04047121|147623985|SUPERIORITY||Cost Ratio|1.1868||||0.0924|TWO_SIDED|95.0|0.9722|1.4487|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4487|0.9722|0.0924
74035756|NCT04047121|147623986|SUPERIORITY|||||||0.6184|||||||t-test, 2 sided|||||||0.6184
74035757|NCT04047121|147623986|SUPERIORITY|||||||0.1952|||||||t-test, 2 sided|||||||0.1952
74035758|NCT04047121|147623986|SUPERIORITY|||||||0.1638|||||||t-test, 2 sided|||||||0.1638
73993950|NCT02358668|147534232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|||<|0.01|TWO_SIDED|95.0|-0.52|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.12|-0.52|<0.01
73993951|NCT02358668|147534232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.14|TWO_SIDED|95.0|-0.34|0.05||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.05|-0.34|0.14
73993952|NCT02358668|147534233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|||<|0.01|TWO_SIDED|95.0|-0.52|-0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.10|-0.52|<0.01
73993953|NCT02358668|147534233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.38|TWO_SIDED|95.0|-0.3|0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.12|-0.30|0.38
73993954|NCT02358668|147534234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.01|TWO_SIDED|95.0|-0.48|-0.07||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.07|-0.48|0.01
73993955|NCT02358668|147534234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.41|TWO_SIDED|95.0|-0.28|0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.11|-0.28|0.41
73993956|NCT02358668|147534235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.08|TWO_SIDED|95.0|-0.4|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.03|-0.40|0.08
73993957|NCT02358668|147534235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.1|TWO_SIDED|95.0|-0.38|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.03|-0.38|0.10
73993958|NCT02358668|147534236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.01|TWO_SIDED|95.0|-0.67|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.12|-0.67|0.01
73993959|NCT02358668|147534236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.54|TWO_SIDED|95.0|-0.35|0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.18|-0.35|0.54
73993960|NCT02358668|147534237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.03|TWO_SIDED|95.0|-0.81|-0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.03|-0.81|0.03
73993961|NCT02358668|147534237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.63|TWO_SIDED|95.0|-0.48|0.29||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.29|-0.48|0.63
73993962|NCT02358668|147534238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.18|TWO_SIDED|95.0|-0.13|0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.02|-0.13|0.18
73993963|NCT02358668|147534238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.73|TWO_SIDED|95.0|-0.06|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.09|-0.06|0.73
73993964|NCT02358668|147534239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.06|TWO_SIDED|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.00|-0.15|0.06
73993965|NCT02358668|147534239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.10|-0.05|0.46
73993966|NCT02358668|147534240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.06|TWO_SIDED|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.00|-0.15|0.06
73993967|NCT02358668|147534240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.10|-0.05|0.46
73993968|NCT02358668|147534241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.03|TWO_SIDED|95.0|-0.31|-0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.02|-0.31|0.03
73993969|NCT02358668|147534241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.87|TWO_SIDED|95.0|-0.13|0.15||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.15|-0.13|0.87
73993970|NCT02358668|147534242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.34|TWO_SIDED|95.0|-1.46|0.5||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.50|-1.46|0.34
73993971|NCT02358668|147534242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.64|TWO_SIDED|95.0|-0.73|1.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.18|-0.73|0.64
73993972|NCT02358668|147534243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.17|TWO_SIDED|95.0|-1.5|0.26||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.26|-1.50|0.17
73993973|NCT02358668|147534243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.37|TWO_SIDED|95.0|-0.46|1.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.24|-0.46|0.37
73993974|NCT02358668|147534244|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.18|TWO_SIDED|95.0|-1.62|0.31||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.31|-1.62|0.18
73993975|NCT02358668|147534244|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.37|TWO_SIDED|95.0|-0.51|1.36||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.36|-0.51|0.37
73993976|NCT02358668|147534245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.14||||0.06|TWO_SIDED|95.0|-4.36|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.09|-4.36|0.06
73993977|NCT02358668|147534245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43||||0.69|TWO_SIDED|95.0|-1.71|2.58||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||2.58|-1.71|0.69
73993978|NCT02358668|147534246|SUPERIORITY_OR_OTHER|||||||0.29||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.29
73993979|NCT02358668|147534246|SUPERIORITY_OR_OTHER|||||||0.22||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.22
73993980|NCT02358668|147534247|SUPERIORITY_OR_OTHER|||||||0.41||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.41
73993981|NCT02358668|147534247|SUPERIORITY_OR_OTHER|||||||0.48||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.48
73993982|NCT02358668|147534248|SUPERIORITY_OR_OTHER|||||||0.61||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.61
73993983|NCT02358668|147534248|SUPERIORITY_OR_OTHER|||||||0.89||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.89
73993984|NCT04057573|147534249|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0004|TWO_SIDED|95.0|1.737|6.835||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.835|1.737|0.0004
73993985|NCT04057573|147534250|SUPERIORITY||Odds Ratio (OR)|3.99|||<|0.0001|TWO_SIDED|95.0|2.296|6.949||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.949|2.296|< 0.0001
73993986|NCT04057573|147534251|SUPERIORITY||Odds Ratio (OR)|15.29||||0.0065|TWO_SIDED|95.0|2.15|108.739||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||108.739|2.150|0.0065
73993987|NCT04057573|147534252|SUPERIORITY||Odds Ratio (OR)|4.29||||0.0006|TWO_SIDED|95.0|1.865|9.853||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.853|1.865|0.0006
73993988|NCT04057573|147534253|SUPERIORITY||Odds Ratio (OR)|4.86||||0.0013|TWO_SIDED|95.0|1.851|12.755||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||12.755|1.851|0.0013
73993989|NCT04057573|147534254|SUPERIORITY||Least squares mean difference|-19.5|STANDARD_ERROR_OF_MEAN|4.59|<|0.0001|TWO_SIDED|95.0|-28.46|-10.45||Response Variable = Treatment + Stratification Factors (Skin Type Fitzpatrick scale Type I, II versus Type III, IV, V, and VI, Region North America/Europe) + Baseline|ANCOVA|||||-10.45|-28.46|< 0.0001
73993990|NCT04057573|147534257|SUPERIORITY||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.267|6.246||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.246|2.267|< 0.0001
73993991|NCT04057573|147534259|SUPERIORITY||Least squares mean difference|-28.59|STANDARD_ERROR_OF_MEAN|4.94|<|0.0001|TWO_SIDED|95.0|-38.33|-18.86|||mixed-effect model; repeated measurement|||||-18.86|-38.33|<0.0001
73993992|NCT04057573|147534262|SUPERIORITY||least squares mean difference|-19.85|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-26.55|-13.16|||mixed-effect model; repeated measurement|||||-13.16|-26.55|<0.0001
73993993|NCT04057573|147534264|SUPERIORITY||least squares mean difference|-11.95|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-17.23|-6.67|||mixed-effect model; repeated measurement|||||-6.67|-17.23|<0.0001
73993994|NCT04057573|147534266|SUPERIORITY||Odds Ratio (OR)|3.75|||<|0.0001|TWO_SIDED|95.0|2.121|6.63||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI25||6.630|2.121|< 0.0001
73993995|NCT04057573|147534266|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0436|TWO_SIDED|95.0|1.045|20.192||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI75||20.192|1.045|0.0436
73993996|NCT04057573|147534266|SUPERIORITY||Odds Ratio (OR)|1.35||||||||||The p value was not evaluable because the response rate in the vehicle group was too low.||||T-VASI90||||
73993997|NCT04057573|147534269|SUPERIORITY||least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.235|TWO_SIDED|95.0|-1.6|0.39|||mixed-effect model; repeated measurement|||||0.39|-1.60|0.2350
74035759|NCT04047121|147623986|SUPERIORITY||Cost Ratio|0.9773||||0.6732|TWO_SIDED|95.0|0.8782|1.0875|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0875|0.8782|0.6732
73993998|NCT01730950|147534275|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.46|TWO_SIDED|95.0|0.7|1.38|||Log Rank|Two-side significance level = 0.05|Reference level = Bevacizumab|Null hypothesis: median survival time for both arms is 9 months; alternative hypothesis: participants receiving radiation therapy plus bevacizumab will have an improvement in median survival time to 13 months. One hundred and sixty eligible participants provides 80% power to detect a 31% reduction in the hazard ratio to 0.69 at a one-sided significance level of 0.10. Analysis was planned to occur when 135 deaths were reported, expected to occur 16 to 21 months after trial closure.||1.38|0.70|0.46
73993999|NCT01730950|147534276|SUPERIORITY|||||||0.18|||||||Chi-squared|Two-sided significance level = 0.05||||||0.18
73994000|NCT01730950|147534277|SUPERIORITY|||||||0.001|||||||Chi-squared|Two-sided significance level = 0.05||||||0.001
73994001|NCT01730950|147534278|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.05|TWO_SIDED|95.0|0.53|1.0|||Log Rank|Two-sided significance level = 0.05|Reference level = Bevacizumab|||1.00|0.53|0.05
73994002|NCT00667459|147534281|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.032||||0.995|TWO_SIDED|95.0|-0.07|0.134||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.134|-0.070|0.995
73994003|NCT00667459|147534281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.736||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.||||0.736
73994004|NCT00667459|147534282|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.048||||1|TWO_SIDED|95.0|-0.02|0.118||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the success rates of NDI in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational group will be claimed for this endpoint."||0.118|-0.020|1.0
73994005|NCT00667459|147534282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.912||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.912
73994006|NCT00667459|147534283|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.099||||1|TWO_SIDED|95.0|0.038|0.161||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.161|0.038|1.0
73994007|NCT00667459|147534283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.999
74035760|NCT04047121|147623986|SUPERIORITY||Cost Ratio|0.9629||||0.6345|TWO_SIDED|95.0|0.824|1.1253|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1253|0.8240|0.6345
73994008|NCT00667459|147534284|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.034||||0.992|TWO_SIDED|95.0|-0.085|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.021|-0.085|0.992
73994009|NCT00667459|147534284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.097||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.097
73994010|NCT00667459|147534285|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.01||||1|TWO_SIDED|95.0|-0.043|0.023||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.023|-0.043|1.0
73994011|NCT00667459|147534285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.273
73994012|NCT00667459|147534286|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.019||||1|TWO_SIDED|95.0|-0.018|0.058||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.058|-0.018|1.0
73994013|NCT00667459|147534286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.845||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.845
73994014|NCT00667459|147534287|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.047||||0.936|TWO_SIDED|95.0|-0.113|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.021|-0.113|0.936
73994015|NCT00667459|147534288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.105||||1|TWO_SIDED|95.0|0.02|0.19||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.190|0.020|1.0
74035761|NCT04047121|147623986|SUPERIORITY||Cost Ratio|0.8327||||0.0029|TWO_SIDED|95.0|0.738|0.9395|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.9395|0.7380|0.0029
74035762|NCT04047121|147623987|SUPERIORITY|||||||0.3087|||||||t-test, 2 sided|||||||0.3087
74035763|NCT04047121|147623987|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
73994016|NCT00667459|147534288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.992
73876758|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||48.5|-15.2|0.408
73994017|NCT00667459|147534290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the operative time in two treatment groups was assessed.||||0.013
73994018|NCT00667459|147534291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.769||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the blood loss in two treatment groups was assessed.||||0.769
73994019|NCT00667459|147534292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the hospital stay in two treatment groups was assessed.||||0.273
73994020|NCT01381575|147534299|NON_INFERIORITY|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.08|0.78||||||Immune response to anti-HPV-16 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.78|-1.08|
73994021|NCT01381575|147534299|NON_INFERIORITY|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.0|0.77||||||Immune response to anti-HPV-18 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.77|-1.00|
73994022|NCT01381575|147534300|NON_INFERIORITY|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|1.09|||||TWO_SIDED|95.0|0.97|1.22||||||Immune response to anti-HPV-16 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||1.22|0.97|
73994023|NCT01381575|147534300|NON_INFERIORITY|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|0.85|||||TWO_SIDED|95.0|0.76|0.95||||||Immune response to anti-HPV-18 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.95|0.76|
73994024|NCT01443403|147534323|SUPERIORITY_OR_OTHER||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.605||0.0003|TWO_SIDED|95.0|1.02|3.41|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as a term and baseline value as a covariate.||||3.41|1.02|0.0003
73994025|NCT01443403|147534323|SUPERIORITY_OR_OTHER||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|0.604||0.0014|TWO_SIDED|95.0|0.76|3.14|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.14|0.76|0.0014
73994026|NCT01443403|147534323|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|0.599||0.3504|TWO_SIDED|95.0|-0.62|1.74|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.74|-0.62|0.3504
73994027|NCT01443403|147534325|SUPERIORITY_OR_OTHER||LS Mean Difference|1.93|STANDARD_ERROR_OF_MEAN|0.568||0.0008|TWO_SIDED|95.0|0.81|3.05|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.05|0.81|0.0008
73994028|NCT01443403|147534325|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|0.569||0.0009|TWO_SIDED|95.0|0.79|3.04|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.04|0.79|0.0009
74035764|NCT04047121|147623987|SUPERIORITY|||||||0.0647|||||||t-test, 2 sided|||||||0.0647
74035765|NCT04047121|147623987|SUPERIORITY||Cost Ratio|0.9762||||0.7684|TWO_SIDED|95.0|0.8316|1.146|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1460|0.8316|0.7684
74035766|NCT04047121|147623987|SUPERIORITY||Cost Ratio|1.3862||||0.0012|TWO_SIDED|95.0|1.1379|1.6886|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6886|1.1379|0.0012
73994029|NCT01443403|147534325|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.558||0.2572|TWO_SIDED|95.0|-0.47|1.73|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.73|-0.47|0.2572
73994030|NCT01443403|147534327|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.484||0.0065|TWO_SIDED|95.0|0.38|2.28|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.28|0.38|0.0065
73994031|NCT01443403|147534327|SUPERIORITY_OR_OTHER||LS Mean Difference|1.64|STANDARD_ERROR_OF_MEAN|0.482||0.0008|TWO_SIDED|95.0|0.69|2.58|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.58|0.69|0.0008
73994032|NCT01443403|147534327|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.476||0.2921|TWO_SIDED|95.0|-0.43|1.44|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.44|-0.43|0.2921
74035767|NCT04047121|147623987|SUPERIORITY||Cost Ratio|1.0065||||0.9422|TWO_SIDED|95.0|0.8452|1.1985|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1985|0.8452|0.9422
74035768|NCT04047121|147623988|SUPERIORITY|||||||0.0421|||||||t-test, 2 sided|||||||0.0421
74035769|NCT04047121|147623988|SUPERIORITY|||||||0.8137|||||||t-test, 2 sided|||||||0.8137
74035770|NCT04047121|147623988|SUPERIORITY|||||||0.9416|||||||t-test, 2 sided|||||||0.9416
73876759|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|33.3||||0.266|TWO_SIDED|95.0|9.5|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.2|9.5|0.266
73994033|NCT01443403|147534329|SUPERIORITY_OR_OTHER||LS Mean Difference|1.44|STANDARD_ERROR_OF_MEAN|0.495||0.0039|TWO_SIDED|95.0|0.47|2.42|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.42|0.47|0.0039
73994034|NCT01443403|147534329|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.492||0.0007|TWO_SIDED|95.0|0.73|2.67|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.67|0.73|0.0007
73994035|NCT01443403|147534329|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.488||0.3077|TWO_SIDED|95.0|-0.46|1.46|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.46|-0.46|0.3077
73994036|NCT01443403|147534331|SUPERIORITY_OR_OTHER||Difference|27.3||||0.003|TWO_SIDED|95.0|10.0|44.6|||Chi-squared|||||44.6|10.0|0.0030
73994037|NCT01443403|147534331|SUPERIORITY_OR_OTHER||Difference|31.8||||0.0005|TWO_SIDED|95.0|15.0|48.7|||Chi-squared|||||48.7|15.0|0.0005
73994038|NCT01443403|147534331|SUPERIORITY_OR_OTHER||Difference|13.1||||0.1461|TWO_SIDED|95.0|-4.4|30.6|||Chi-squared|||||30.6|-4.4|0.1461
73994039|NCT01443403|147534333|SUPERIORITY_OR_OTHER||Difference|24.3||||0.005|TWO_SIDED|95.0|7.8|40.8|||Chi-squared|||||40.8|7.8|0.0050
73994040|NCT01443403|147534333|SUPERIORITY_OR_OTHER||Difference|24.5||||0.0045|TWO_SIDED|95.0|8.1|40.8|||Chi-squared|||||40.8|8.1|0.0045
73994041|NCT01443403|147534333|SUPERIORITY_OR_OTHER||Difference|8.2||||0.2984|TWO_SIDED|95.0|-7.2|23.6|||Chi-squared|||||23.6|-7.2|0.2984
73994042|NCT01443403|147534335|SUPERIORITY_OR_OTHER||LS Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|0.9|2.17|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.17|0.90|<0.0001
74035771|NCT04047121|147623988|SUPERIORITY||Cost Ratio|0.9515||||0.319|TWO_SIDED|95.0|0.8628|1.0493|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0493|0.8628|0.3190
74035772|NCT04047121|147623988|SUPERIORITY||Cost Ratio|0.8991||||0.1368|TWO_SIDED|95.0|0.7815|1.0343|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0343|0.7815|0.1368
74035773|NCT04047121|147623988|SUPERIORITY||Cost Ratio|0.8514||||0.0231|TWO_SIDED|95.0|0.7411|0.9782|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.9782|0.7411|0.0231
74035774|NCT02604810|147623994|NON_INFERIORITY|Method of estimation = least-squares means based on analysis of variance (ANOVA) with a mixed-effect model. The lower bound of the 90% confidence interval (CI) for the geometric LSM ratio (SC/IV) of the primary PK endpoint of steady state AUC0-7 days for the PK population should be above 0.80.|Geometric least-squares mean ratio|1.04|||||TWO_SIDED|90.0|1.0|1.07||||||||1.07|1.00|
74035775|NCT02625324|147623997|SUPERIORITY||Event Rate|0.023|||<|0.0001|ONE_SIDED|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p \<16%, where p denotes the true event rate of primary study endpoint in the target population."||0.081||<0.0001
74035776|NCT00424528|147624037|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as covariate and treatment group as fixed effect.||||||<0.001
74035777|NCT00424528|147624037|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study Baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
74035778|NCT00424528|147624037|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Primary analysis:Group 2 vs 3. Key secondary analysis: Group 1 vs 3. Multiple comparisons for the analysis of the primary endpoint were controlled at the 5% level.|ANCOVA|Study baseline FEV1 as a covariate and treatment group as fixed effect.||||||<0.001
73876760|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-33.3||||0.121|TWO_SIDED|95.0|-66.2|-0.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||-0.5|-66.2|0.121
73994043|NCT01443403|147534335|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.32||0.0002|TWO_SIDED|95.0|0.59|1.85|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.85|0.59|0.0002
73994044|NCT01443403|147534335|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.317||0.0698|TWO_SIDED|95.0|-0.05|1.2|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.20|-0.05|0.0698
73994045|NCT01443403|147534337|SUPERIORITY_OR_OTHER||LS Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|0.307||0.0001|TWO_SIDED|95.0|0.58|1.79|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.79|0.58|0.0001
73994046|NCT01443403|147534337|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.305||0.0004|TWO_SIDED|95.0|0.49|1.7|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.70|0.49|0.0004
73994047|NCT01443403|147534337|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.302||0.1648|TWO_SIDED|95.0|-0.17|1.02|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.02|-0.17|0.1648
73994048|NCT01443403|147534339|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
73994049|NCT01443403|147534339|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73876761|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-10.0||||-10|TWO_SIDED|95.0|-34.6|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||14.6|-34.6|-10.0
73994050|NCT01443403|147534339|SUPERIORITY_OR_OTHER|||||||0.0118||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0118
74035779|NCT00424528|147624038|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
73876762|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-6.0|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||19.3|-6.0|1.000
73994051|NCT01443403|147534340|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73994052|NCT01443403|147534340|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0011
73994053|NCT01443403|147534340|SUPERIORITY_OR_OTHER|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
73994054|NCT01443403|147534343|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.358||0.0003|TWO_SIDED|95.0|0.62|2.03|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.03|0.62|0.0003
73994055|NCT01443403|147534343|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|STANDARD_ERROR_OF_MEAN|0.359|<|0.0001|TWO_SIDED|95.0|0.8|2.22|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.22|0.80|<0.0001
73994056|NCT01443403|147534343|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.352||0.1211|TWO_SIDED|95.0|-0.15|1.24|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.24|-0.15|0.1211
73994057|NCT01443403|147534345|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|STANDARD_ERROR_OF_MEAN|0.551|<|0.0001|TWO_SIDED|95.0|1.28|3.45|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.45|1.28|<0.0001
73994058|NCT01443403|147534345|SUPERIORITY_OR_OTHER||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.549||0.0002|TWO_SIDED|95.0|0.99|3.15|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.15|0.99|0.0002
73994059|NCT01443403|147534345|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.542||0.2022|TWO_SIDED|95.0|-0.37|1.76|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.76|-0.37|0.2022
73994060|NCT01443403|147534348|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0272
73994061|NCT01443403|147534348|SUPERIORITY_OR_OTHER|||||||0.1355||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1355
73994062|NCT01443403|147534348|SUPERIORITY_OR_OTHER|||||||0.3689||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3689
73994063|NCT01443403|147534350|SUPERIORITY_OR_OTHER|||||||0.2126||95.0|||||Welch's t-test|||||||0.2126
73994064|NCT01443403|147534350|SUPERIORITY_OR_OTHER|||||||0.2799||95.0|||||Welch's t-test|||||||0.2799
73994065|NCT01443403|147534350|SUPERIORITY_OR_OTHER|||||||0.6466||95.0|||||Welch's t-test|||||||0.6466
73994066|NCT01443403|147534352|SUPERIORITY_OR_OTHER|||||||0.9826||95.0|||||Welch's t-test|||||||0.9826
73994067|NCT01443403|147534352|SUPERIORITY_OR_OTHER|||||||0.5188||95.0|||||Welch's t-test|||||||0.5188
73994068|NCT01443403|147534352|SUPERIORITY_OR_OTHER|||||||0.5029||95.0|||||Welch's t-test|||||||0.5029
73994069|NCT00474526|147534362|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.53|||||TWO_SIDED|95.0|3.04|6.74|||ANOVA||A (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||6.74|3.04|
74035780|NCT00424528|147624038|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.001
74035781|NCT00424528|147624039|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.001
74035782|NCT00424528|147624039|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
74035783|NCT00424528|147624040|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.073
74035784|NCT00424528|147624040|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.050
73876763|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-45.3|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||31.9|-45.3|1.000
73876764|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||48.5|-15.2|0.408
73876765|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-29.1|55.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||55.7|-29.1|1.000
73876766|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-26.7||||0.241|TWO_SIDED|95.0|-65.3|11.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||11.9|-65.3|0.241
73876767|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||48.5|-15.2|0.408
73876768|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-29.1|55.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||55.7|-29.1|1.000
73876769|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|-3.3||||1|TWO_SIDED|95.0|-43.3|36.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||36.6|-43.3|1.000
73876770|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|30.0||||0.217|TWO_SIDED|95.0|-2.9|62.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||62.9|-2.9|0.217
73876771|NCT02365649|147294843|SUPERIORITY||Risk Difference (RD)|26.7||||0.603|TWO_SIDED|95.0|-16.5|69.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||69.9|-16.5|0.603
73876772|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|12.5||||0.686|TWO_SIDED|95.0|-27.6|52.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||52.6|-27.6|0.686
73876773|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.3|-12.8|0.257
73876774|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||27.4|-47.4|0.709
73994070|NCT00474526|147534362|SUPERIORITY_OR_OTHER||Ratio of GMTs|6.39|||||TWO_SIDED|95.0|4.16|9.79|||ANOVA||C (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||9.79|4.16|
73876775|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|3.7||||1|TWO_SIDED|95.0|-16.6|24.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||24.1|-16.6|1.000
73994071|NCT00474526|147534362|SUPERIORITY_OR_OTHER||Ratio of GMTs|37.0|||||TWO_SIDED|95.0|24.0|58.0|||ANOVA||W (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||58|24|
73994072|NCT00474526|147534362|SUPERIORITY_OR_OTHER||Ratio of GMTs|38.0|||||TWO_SIDED|95.0|24.0|60.0|||ANOVA||Y (Post-vaccination GMT; group ratio US1A:US2)|"Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.~Ratio of GMTs"||60|24|
73994073|NCT00474526|147534371|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.55|0.95|||ANOVA|||Serogroup A (Post-vaccination GMT; group ratio LA1:LA3)||0.95|0.55|
73994074|NCT00474526|147534371|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.81|1.31|||ANOVA|||Serogroup C (Post-vaccination GMT; group ratio LA1:LA3)||1.31|0.81|
73994075|NCT00474526|147534371|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.42|||||TWO_SIDED|95.0|1.18|1.72|||ANOVA|||Serogroup W (Post-vaccination GMT; group ratio LA1:LA3)||1.72|1.18|
74035785|NCT00424528|147624043|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANCOVA|Week 0 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0 comparisons||||0.060
73994076|NCT00474526|147534371|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.27|||||TWO_SIDED|95.0|1.02|1.58|||ANOVA|||Serogroup Y (Post-vaccination GMT; group ratio LA1:LA3)||1.58|1.02|
73994077|NCT00474526|147534374|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-15.0|||||TWO_SIDED|95.0|-21.2|-8.5|||ANOVA|||Serogroup A (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||-8.5|-21.2|
73994078|NCT00474526|147534374|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-3.0|||||TWO_SIDED|95.0|-7.0|0.3|||ANOVA|||Serogroup C (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||0.3|-7|
74090126|NCT03265288|147733470|SUPERIORITY||Least Squares Means difference|-576.0||||0.0603|TWO_SIDED|95.0|-1177.0|25.4||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|Calprotectin, Intent-to-Treat population (ITT), null hypothesis is no treatment effect||25.4|-1177|0.0603
73994079|NCT00474526|147534374|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|1.0|||||TWO_SIDED|95.0|-1.3|3.1|||ANOVA|||Serogroup W (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||3.1|-1.3|
73994080|NCT00474526|147534374|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-1.0|||||TWO_SIDED|95.0|-4.0|1.7|||ANOVA|||Serogroup Y (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||1.7|-4|
73994081|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.87|||||TWO_SIDED|95.0|0.74|1.04|||ANOVA|||Diphtheria (Post-vaccination GMT; group ratio US1:US2)||1.04|0.74|
74090127|NCT03265288|147733470|SUPERIORITY||Least Square Means difference|-3.853||||0.0287|TWO_SIDED|95.0|-7.297|-0.408||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|C-Reactive Protein (CRP), Per-Protocol population (PP), null hypothesis is no treatment effect||-0.408|-7.297|0.0287
73994082|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.08|||||TWO_SIDED|95.0|0.92|1.28|||ANOVA|||Tetanus (Post-vaccination GMT; group ratio US1:US2)||1.28|0.92|
73994083|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.79|1.26|||ANOVA|||PT (Post-vaccination GMT; group ratio US1:US2)||1.26|0.79|
73994084|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||FHA (Post-vaccination GMT; group ratio US1:US2)||1.25|0.85|
73994085|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.04|||||TWO_SIDED|95.0|0.83|1.32|||ANOVA|||Pertactin (Post-vaccination GMT; group ratio US1:US2||1.32|0.83|
74035786|NCT00424528|147624043|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0||||<0.001
74035787|NCT00424528|147624043|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons||||0.004
74035788|NCT00424528|147624043|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons||||0.002
74035789|NCT00424528|147624046|SUPERIORITY_OR_OTHER|||||||0.206||95.0|||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.||||||0.206
74035790|NCT00424528|147624046|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.||||||0.025
74035791|NCT00967226|147624057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_DEVIATION|0.05||0.77|||||||t-test, 2 sided|||intention to treat analysis||||0.77
73994086|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.96|||||TWO_SIDED|95.0|0.75|1.23|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio US1:US2)||1.23|0.75|
73994087|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.2|||||TWO_SIDED|95.0|0.93|1.55|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio US1:US2)||1.55|0.93|
74090128|NCT03265288|147733470|SUPERIORITY||Least Square Means difference|-620.0||||0.0459|TWO_SIDED|95.0|-1228.0|12.0||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|Calprotectin, Per-Protocol population (PP), null hypothesis is no treatment effect||12|-1228|0.0459
73994088|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.15|||||TWO_SIDED|95.0|0.85|1.56|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio US1:US2)||1.56|0.85|
74090129|NCT03265288|147733471|SUPERIORITY||Least Squares Means difference|-0.39||||0.1006|TWO_SIDED|95.0|-0.86|0.08||alpha is set to 0.05|Mixed Model for Repeated Measures|||Body weight, Intent to treat population (ITT), null hypothesis is no treatment effect||0.08|-0.86|0.1006
73994089|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.88||||||95.0|0.65|1.2|||ANOVA|||Hepatitis B (Post-vaccination GMT; group ratio US1:US2)||1.2|0.65|
74090130|NCT03265288|147733472|SUPERIORITY||Least Squares Means difference|-0.137||||0.1246|TWO_SIDED|95.0|-0.312|0.038||alpha is set to 0.05|Mixed Model for Repeated Measures|||Body mass index, intent to treat population (ITT), null hypothesis is no treatment effect||0.038|-0.312|0.1246
74090131|NCT03265288|147733473|SUPERIORITY|||||||0.764||||||alpha is set to 0.05|ANOVA|||Intent to treat population (ITT), null hypothesis is no treatment effect||||0.7640
74090132|NCT03265288|147733474|SUPERIORITY||Least Squares Means difference|-2.758||||0.2996|TWO_SIDED|95.0|-7.998|2.482||alpha is set to 0.05|Mixed Model for Repeated Measures|||CFQ-R Respiratory subscore, intent to treat population (ITT), null hypothesis is no treatment effect||2.482|-7.998|0.2996
73994090|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.31|||||TWO_SIDED|95.0|0.97|1.77|||ANOVA|||HIb (Post-vaccination GMT; group ratio US1:US2)||1.77|0.97|
73876776|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|8.5||||0.428|TWO_SIDED|95.0|-6.1|23.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||23.0|-6.1|0.428
73876777|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|6.8||||0.639|TWO_SIDED|95.0|-9.3|22.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||22.9|-9.3|0.639
73876778|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|8.5||||0.583|TWO_SIDED|95.0|-22.2|39.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||39.2|-22.2|0.583
73876779|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|17.3||||0.171|TWO_SIDED|95.0|-7.2|41.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||41.9|-7.2|0.171
73876780|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|2.5||||0.859|TWO_SIDED|95.0|-24.8|29.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.7|-24.8|0.859
73876781|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
73876782|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||13.0|-13.4|1.000
73876783|NCT02365649|147294844|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
73876784|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-23.9|28.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||28.9|-23.9|1.000
73876785|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|21.3||||0.204|TWO_SIDED|95.0|-5.0|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||47.5|-5.0|0.204
73876786|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|-10.0||||0.54|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||3.1|-23.1|0.540
73876787|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|-6.3||||1|TWO_SIDED|95.0|-14.6|2.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||2.1|-14.6|1.000
73994091|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.84|||||TWO_SIDED|95.0|0.7|1.0|||ANOVA|||PnC 4 (Post-vaccination GMT; group ratio US1:US2)||1|0.7|
73876788|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|2.6||||1|TWO_SIDED|95.0|-10.1|15.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.3|-10.1|1.000
73994092|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.56|1.03|||ANOVA|||PnC 6B (Post-vaccination GMT; group ratio US1:US2)||1.03|0.56|
73994093|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.85||||||95.0|0.7|1.04|||ANOVA|||PnC 9V (Post-vaccination GMT; group ratio US1:US2)||1.04|0.7|
74039711|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0092|TWO_SIDED|95.0|1.09|1.81|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.81|1.09|0.0092
73994094|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.26|||ANOVA|||PnC 14 (Post-vaccination GMT; group ratio US1:US2)||1.26|0.84|
73994095|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.77|||||TWO_SIDED|95.0|0.64|0.93|||ANOVA|||PnC 18C (Post-vaccination GMT; group ratio US1:US2)||0.93|0.64|
73994096|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.82|||||TWO_SIDED|95.0|0.69|0.97|||ANOVA|||PnC 19F (Post-vaccination GMT; group ratio US1:US2)||0.97|0.69|
73994097|NCT00474526|147534376|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.79|||||TWO_SIDED|95.0|0.62|1.02|||ANOVA|||PnC 23F (Post-vaccination GMT; group ratio US1:US2)||1.02|0.62|
73994098|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Diphtheria (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
73994099|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Tetanus (Seroconversion percentage difference (PUS1 - PUS2))||4|-2|
73876789|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|2.4||||1|TWO_SIDED|95.0|-11.8|16.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||16.7|-11.8|1.000
73876790|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|0.9||||1|TWO_SIDED|95.0|-15.0|16.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||16.8|-15.0|1.000
73994100|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-7.0|12.0|||ANOVA|||PT (Seroconversion percentage difference (PUS1 - PUS2))||12|-7|
73994101|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|6.0|||||TWO_SIDED|95.0|-4.0|17.0|||ANOVA|||FHA(Seroconversion percentage difference (PUS1 - PUS2))||17|-4|
73994102|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-12.0|10.0|||ANOVA|||Pertactin (Seroconversion percentage difference (PUS1 - PUS2))||10|-12|
74035792|NCT00165841|147624077|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was adjusted for multiple comparisons.|t-test, 2 sided|The primary analysis was on the ITT population using all observed data collected from Day 1 of the maintenance phase until the endpoint.||Efficacy analyses were based on the intent-to-treat (ITT) population, which was comprised of all patients in the safety-evaluable population who had a baseline and ≥1 post-randomization primary efficacy endpoint evaluation and who had received ≥1 dose of study medication during the maintenance phase.||||<0.0001
73994103|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
73994104|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PUS1 - PUS2))||4|-2|
73994105|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
73994106|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||ANOVA|||Hepatitis B(Seroconversion percentage difference (PUS1 - PUS2))||3|-4|
74035793|NCT02568345|147624118|SUPERIORITY_OR_OTHER||isotonic regression functions through PA|2.2|||||TWO_SIDED|||||The isotonic regression functions through PAVA algorithm were used (pooled adjacent violators algorithm), to determine the ED90, and bootstrapping to calculate the respective 95% confidence interval with the statistical program R||||||||
74035794|NCT00831441|147624146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.5094|TWO_SIDED|95.0|0.8|1.11|||Cox proportional hazard models|||A test of superiority at the one-sided α = 0.025 significance level for the primary efficacy outcome was performed.||1.11|0.80|0.5094
73994107|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
73994108|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|5.0|||||TWO_SIDED|95.0|-3.0|14.0|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))||14|-3|
73994109|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-5.0|2.0|||ANOVA|||PnC 4(Seroconversion percentage difference (PUS1 - PUS2))||2|-5|
73994110|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-8.0|||||TWO_SIDED|95.0|-14.0|-1.0|||ANOVA|||PnC 6B(Seroconversion percentage difference (PUS1 - PUS2))||-1|-14|
73994111|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-4.0|5.0|||ANOVA|||PnC 9V (Seroconversion percentage difference (PUS1 - PUS2))||5|-4|
73994112|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Diphtheria (Seroconversion percentage di|1.0|||||TWO_SIDED|95.0|-1.0|5.0|||ANOVA|||PnC 14 (Seroconversion percentage difference (PUS1 - PUS2))||5|-1|
73994113|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-3.0|||||TWO_SIDED|95.0|-6.0|1.0|||ANOVA|||PnC 18C (Seroconversion percentage difference (PUS1 - PUS2))||1|-6|
73994114|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||ANOVA|||PnC 19F (Seroconversion percentage difference (PUS1 - PUS2))||3|-4|
73994115|NCT00474526|147534377|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-8.0|5.0|||ANOVA|||PnC 23F (Seroconversion percentage difference (PUS1 - PUS2))||5|-8|
73994116|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.16|||||TWO_SIDED|95.0|0.96|1.4|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA1:LA2)||1.4|0.96|
74035795|NCT00831441|147624147|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.6702|TWO_SIDED|95.0|0.7|1.26|||Cox proportional hazard models|||||1.26|0.70|0.6702
74035796|NCT00831441|147624148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.6311|TWO_SIDED|95.0|0.57|1.4|||Cox proportional hazard models|||||1.40|0.57|0.6311
74090133|NCT03197558|147733479|SUPERIORITY|Upper confidence limit of mean VAS score hypothesized to be less than (superior) to a performance goal of 45 mm.|Bootstrap method|14.35|||||ONE_SIDED|97.5||14.35||||||Mean VAS score compared to performance goal using a bootstrap method test at 2.5% significance.||14.35||
74090134|NCT00468728|147733482|NON_INFERIORITY_OR_EQUIVALENCE|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.8|6.8||||||H0: C(OPT-80) - C(VAN) \<= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.||6.8|-4.8|
74090135|NCT00468728|147733483|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-14.4|||<|0.001|TWO_SIDED|95.0|-21.6|-7.0|||Chi-squared|||||-7.0|-21.6|<0.001
73994117|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.1|||||TWO_SIDED|95.0|0.96|1.27|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA1:LA2)||1.27|0.96|
74035797|NCT00831441|147624149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5086|TWO_SIDED|95.0|0.76|1.14|||Cox proportional hazard models|||||1.14|0.76|0.5086
74035798|NCT00831441|147624150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1502|TWO_SIDED|95.0|0.47|1.12|||Cox proportional hazard models|||||1.12|0.47|0.1502
74035799|NCT00831441|147624151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4317|TWO_SIDED|95.0|0.82|1.09|||Cox proportional hazard models|||||1.09|0.82|0.4317
74035800|NCT00831441|147624152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.8015|TWO_SIDED|95.0|0.83|1.15|||Cox proportional hazard models|||||1.15|0.83|0.8015
74090136|NCT00468728|147733484|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.4||||0.001||95.0|5.4|21.1|||Chi-squared|||||21.1|5.4|0.001
74090137|NCT03463993|147733492|SUPERIORITY|||||||0.549||||||The p-value above is the calculated P value based on hematocrit.|Chi-squared|||The null hypothesis was that intravenous Tranexamic Acid (TXA) 10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section||||0.549
74035801|NCT00831441|147624153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8948|TWO_SIDED|95.0|0.85|1.15|||Cox proportional hazard models|||||1.15|0.85|0.8948
73994118|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.04|||||TWO_SIDED|95.0|0.87|1.25|||ANOVA|||PT (Post-vaccination GMC; group ratio LA1:LA2)||1.25|0.87|
73994119|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.05|||||TWO_SIDED|95.0|0.89|1.23|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA1:LA2)||1.23|0.89|
73994120|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.99|||||TWO_SIDED|95.0|0.81|1.21|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA1:LA2)||1.21|0.81|
73994121|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.68|1.17|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio LA1:LA2)||1.17|0.68|
73994122|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.97|||||TWO_SIDED|95.0|0.73|1.28|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio LA1:LA2)||1.28|0.73|
73994123|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.95||||||95.0|0.69|1.31|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio LA1:LA2)||1.31|0.69|
73994124|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.11|||||TWO_SIDED|95.0|0.88|1.4|||ANOVA|||Hepatitis B (Post-vaccination GMC; group ratio LA1:LA2)||1.4|0.88|
73994125|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.27|||||TWO_SIDED|95.0|0.98|1.65|||ANOVA|||HIb (Post-vaccination GMC; group ratio LA1:LA2)||1.65|0.98|
73994126|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.92|||||TWO_SIDED|95.0|0.78|1.09|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio LA1:LA2)||1.09|0.78|
73994127|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.97|||||TWO_SIDED|95.0|0.74|1.27|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA1:LA2)||1.27|0.74|
73994128|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.71|1.04|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA1:LA2)||1.04|0.71|
73994129|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.72|1.14|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA1:LA2)||1.14|0.72|
73994130|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.74|1.08|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA1:LA2)||1.08|0.74|
73994131|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.74|1.1|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA1:LA2)||1.1|0.74|
73994132|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.6|0.99|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA1:LA2)||0.99|0.6|
73994133|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.69|0.99|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA3:LA4)||0.99|0.69|
73994134|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.83|1.09|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA3:LA4)||1.09|0.83|
73994135|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.93||||||95.0|0.78|1.1|||ANOVA|||PT (Post-vaccination GMC; group ratio LA3:LA4)||1.1|0.78|
73994136|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||TWO_SIDED|95.0|0.75|1.03|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA3:LA4)||1.03|0.75|
73994137|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.66|0.97|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA3:LA4||0.97|0.66|
73994138|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.78|||||TWO_SIDED|95.0|0.6|1.02|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio LA3:LA4)||1.02|0.6|
73994139|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.63|1.09|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio LA3:LA4)||1.09|0.63|
73994140|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.59|1.11|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio LA3:LA4)||1.11|0.59|
73994141|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.76|1.19|||ANOVA|||Hepatitis B (Post-vaccination GMT; group ratio LA3:LA4)||1.19|0.76|
73994142|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|1.07|||||TWO_SIDED|95.0|0.83|1.37|||ANOVA|||HIb (Post-vaccination GMC; group ratio LA3:LA4)||1.37|0.83|
73994143|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.68|0.95|||ANOVA|||PnC 4 (Post-vaccination GMT; group ratio LA3:LA4)||0.95|0.68|
73994144|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.87|||||TWO_SIDED|95.0|0.67|1.14|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA3:LA4)||1.14|0.67|
73994145|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.83|||||TWO_SIDED|95.0|0.69|1.0|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA3:LA4)||1|0.69|
74035802|NCT00831441|147624154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.59||||0.0006|TWO_SIDED|95.0|1.5|4.46|||Cox Proportional Hazard model|||A point estimate and two-sided 95% confidence interval (CI) for relative risk, as measured by the hazard ratio and a p-value for the test of equality of rates (HR = 1) was calculated.||4.46|1.50|0.0006
74090138|NCT03463993|147733492|SUPERIORITY|||||||0.138||||||This is the calculated p-value based on hemoglobin .|Chi-squared|||The null hypothesis was that intravenous Tranexamic Acid (TXA)10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section||||0.138
74035803|NCT00831441|147624155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.48|||<|0.0001|TWO_SIDED|95.0|1.72|3.58|||Cox Proportional Hazard model|||||3.58|1.72|<0.0001
74035804|NCT00831441|147624156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.87|3.72|||Cox Proportional Hazard model|||||3.72|1.87|<0.0001
74035805|NCT00831441|147624157|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36|||<|0.0001|TWO_SIDED|95.0|2.06|2.7|||Cox Proportional Hazard model|||||2.70|2.06|<0.0001
74090139|NCT03463993|147733493|SUPERIORITY|||||||0.789||||||0.789 is the calculated p-value for visually estimated blood loss: Visually estimated blood loss (ml): Group A mean 483.73 (standard deviation182.56); Group B 479.61 (139.49); p-value 0.789|t-test, 2 sided|||||||0.789
74090140|NCT03463993|147733493|SUPERIORITY|||||||0.968||||||0.968 is the calculated p-value based on hematocrit. Hematocrit-based calculation of estimated blood loss(ml): Group A mean 650.06 (standard deviation 631.50); Group B 653.05 (796.03); p-value 0.968|t-test, 2 sided|||||||0.968
74090141|NCT03463993|147733493|SUPERIORITY|||||||0.447||||||Hemoglobin-based calculation of estimated blood loss(ml) mean(standard deviation): Group A 644.30 (692.27); Group B 707.68 (948.01); p-value 0.447|t-test, 2 sided|||||||0.447
74090142|NCT03463993|147733494|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73876791|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|14.4||||0.135|TWO_SIDED|95.0|-2.5|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-2.5|0.135
74090143|NCT03463993|147733495|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
74090144|NCT04323098|147733505|SUPERIORITY|||||||0.0057||||||P-value was based on two-sided t-test against 0.|t-test, 2 sided|||||||0.0057
73876792|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|4.3||||0.623|TWO_SIDED|95.0|-11.9|20.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||20.4|-11.9|0.623
73876793|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||3.1|-23.1|1.000
73876794|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||17.7|-18.7|1.000
73994146|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.84||||||95.0|0.67|1.05|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA3:LA4)||1.05|0.67|
73994147|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.62|0.9|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA3:LA4)||0.9|0.62|
73994148|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.75|1.1|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA3:LA4)||1.1|0.75|
73994149|NCT00474526|147534378|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||TWO_SIDED|95.0|0.69|1.12|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA3:LA4)||1.12|0.69|
73994150|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.2|4.4|||ANOVA|||Diphtheria (Seroconversion percentage difference (PLA1 - PLA2))||4.4|-2.2|
73994151|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-1.9|2.6|||ANOVA|||Tetanus (Seroconversion percentage difference (PLA1 - PLA2))||2.6|-1.9|
73994152|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-7.7|7.1|||ANOVA|||PT (Seroconversion percentage difference (PLA1 - PLA2))||7.1|-7.7|
74090145|NCT02278718|147733521|SUPERIORITY|||||||0.0008|||||||Generalized Wilcoxon-Gehan Test|||Wilcoxon test statistic was estimated using generalized Wilcoxon-Gehan test stratified by center group, age group, % TBSA group, proportion of FT area group and number of TWs group. A negative (positive) statistic is associated with longer (shorter) time to the event when treated with NexoBrid vs. Standard of Care. P-value was calculated using the re-randomization test.||||0.0008
74090146|NCT02278718|147733522|SUPERIORITY||Odds Ratio (OR)|0.025|||<|0.0001|TWO_SIDED|95.0|0.007|0.09|||Fisher Exact|||Incidence of Surgical Excision for Eschar Removal for NexoBrid vs SOC||0.090|0.007|<0.0001
74090147|NCT02278718|147733523|SUPERIORITY|||||||0.1374|||||||t-test, 2 sided|||||||0.1374
74090148|NCT02278718|147733524|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.5045|TWO_SIDED||||||t-test, 2 sided|||||||0.5045
74090149|NCT02278718|147733525|SUPERIORITY||Odds Ratio (OR)|0.414||||0.0545|TWO_SIDED|95.0|0.163|1.054|||t-test, 2 sided|||||1.054|0.163|0.0545
74090150|NCT04440449|147733526|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
74090151|NCT04440449|147733527|SUPERIORITY|||||||0.108|||||||t-test, 2 sided|||||||0.108
74090152|NCT01763918|147733536|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-59.23|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-65.11|-53.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.35|-65.11|<0.001
73876795|NCT02365649|147294845|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||3.1|-23.1|0.501
73876796|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-23.9|28.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||28.9|-23.9|1.000
73994153|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-9.2|5.8|||ANOVA|||FHA(Seroconversion percentage difference (PLA1 - PLA2))||5.8|-9.2|
73994154|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-6.0||||||95.0|-12.9|2.2|||ANOVA|||Pertactin (Seroconversion percentage difference (PLA1 - PLA2))||2.2|-12.9|
73994155|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|1.0|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PLA1 - PLA2))||1.0|-4.8|
73994156|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.6|2.3|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PLA1 - PLA2))||2.3|-4.6|
73994157|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.2|5.1|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PLA1 - PLA2))||5.1|-3.2|
73994158|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-1.5|3.5|||ANOVA|||Hepatitis B (Seroconversion percentage difference (PLA1 - PLA2))||3.5|-1.5|
73994159|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-1.1|5.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))||5|-1.1|
73994160|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0||||||95.0|-2.8|7.7|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))||7.7|-2.8|
73994161|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.3|||ANOVA|||PnC 4(Seroconversion percentage difference (PLA1 - PLA2))||3.3|-3|
73994162|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|4.0|||||TWO_SIDED|95.0|-2.2|12.3|||ANOVA|||PnC 6B(Seroconversion percentage difference (PLA1 - PLA2))||12.3|-2.2|
73994163|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.9|3.6|||ANOVA|||PnC 9V (Seroconversion percentage difference (PLA1 - PLA2))||3.6|-3.9|
74090153|NCT01763918|147733536|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-61.27|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-69.0|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.55|-69.00|<0.001
73994164|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-1.1|6.2|||ANOVA|||PnC 14 (Seroconversion percentage difference (PLA1 - PLA2))||6.2|-1.1|
73994165|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|2.9|||ANOVA|||PnC 18C (Seroconversion percentage difference (PLA1 - PLA2))||2.9|-4.8|
73994166|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|2.9|||ANOVA|||PnC 19F (Seroconversion percentage difference (PLA1 - PLA2))||2.9|-4.8|
73994167|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-4.0|||||TWO_SIDED|95.0|-8.0|1.9|||ANOVA|||PnC 23F (Seroconversion percentage difference (PLA1 - PLA2))||1.9|-8|
73994168|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.3|3.8|||ANOVA|||Diphtheria (Seroconversion percentage difference (PLA3 - PLA4))||3.8|-2.3|
73994169|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0||||||95.0|-1.3|2.7|||ANOVA|||Tetanus (Seroconversion percentage difference (PLA3 - PLA4))||2.7|-1.3|
73994170|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-4.8|10.7|||Seroconversion Percentage difference|||PT (Seroconversion percentage difference (PLA3 - PLA4))||10.7|-4.8|
73994171|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-7.1|8.8|||ANOVA|||FHA(Seroconversion percentage difference (PLA3 - PLA4))||8.8|-7.1|
73994172|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-8.0|5.7|||ANOVA|||Pertactin (Seroconversion percentage difference (PLA3 - PLA4))||5.7|-8|
73994173|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.7|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PLA3 - PLA4))||4.7|-2|
73994174|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|4.8|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PLA3 - PLA4))||4.8|-3|
73994175|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.4|4.5|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PLA3 - PLA4))||4.5|-4.4|
73994176|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.3|2.7|||ANOVA|||Hepatitis B (Seroconversion percentage difference (PLA3 - PLA4))||2.7|-2.3|
73994177|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-5.3|1.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))||1|-5.3|
73994178|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0||||||95.0|-6.6|3.0|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))||3|-6.6|
73994179|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.2|3.0|||ANOVA|||PnC 4 (Seroconversion percentage difference (PLA3 - PLA4))||3|-4.2|
73994180|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-4.0|9.0|||ANOVA|||PnC 6B (Seroconversion percentage difference (PLA3 - PLA4))||9|-4|
73994181|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-2.8|6.0|||ANOVA|||PnC 9V (Seroconversion percentage difference (PLA3 - PLA4))||6|-2.8|
73994182|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.7|3.4|||ANOVA|||PnC 14 (Seroconversion percentage difference (PLA3 - PLA4))||3.4|-3.7|
73994183|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-3.0|||||TWO_SIDED|95.0|-7.2|0.8|||ANOVA|||PnC 18C (Seroconversion percentage difference (PLA3 - PLA4))||0.8|-7.2|
73994184|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-0.8|7.5|||ANOVA|||PnC 19F (Seroconversion percentage difference (PLA3 - PLA4))||7.5|-0.8|
73994185|NCT00474526|147534379|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0||||||95.0|-3.7|7.0|||ANOVA|||PnC 23F (Seroconversion percentage difference (PLA3 - PLA4))||7|-3.7|
73994186|NCT00474526|147534394|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.67|1.2|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio US1A:US1B)||1.2|0.67|
73994187|NCT00474526|147534394|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.62|1.02|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio US1A:US1B)||1.02|0.62|
73994188|NCT00474526|147534394|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.67|1.2|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio US1A:US1B)||1.2|0.67|
73994189|NCT00474526|147534394|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.63|1.03|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio US1A:US1B)||1.03|0.63|
73994190|NCT00474526|147534394|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.02|||||TWO_SIDED|95.0|0.78|1.34|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio US1A:US1B)||1.34|0.78|
73994191|NCT00474526|147534394|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.04||||||95.0|0.81|1.34|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio US1A:US1B)||1.34|0.81|
73994192|NCT00474526|147534394|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.69|1.29|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio US1A:US1B)||1.29|0.69|
73994193|NCT00474526|147534395|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|1.0|||||TWO_SIDED|95.0|-8.0|10.0|||ANOVA|||PnC 4 (percentage difference (US1A - US1B))||10|-8|
73994194|NCT00474526|147534395|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||TWO_SIDED|95.0|0.0|10.0|||ANOVA|||PnC 6B (percentage difference (US1A - US1B))||10|0|
73994195|NCT00474526|147534395|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-4.0|||||TWO_SIDED|95.0|-13.0|5.0|||ANOVA|||PnC 9V (percentage difference (US1A - US1B))||5|-13|
73994196|NCT00474526|147534395|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0|||ANOVA|||PnC 14 (percentage difference (US1A - US1B))||3|-6|
74035806|NCT00960934|147624166|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.56||||0.749|TWO_SIDED|95.0|-1.04|2.16||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.16|-1.04|0.749
73876797|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|21.3||||0.204|TWO_SIDED|95.0|-5.0|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||47.5|-5.0|0.204
73994197|NCT00474526|147534395|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-6.0|||||TWO_SIDED|95.0|-15.0|3.0|||ANOVA|||PnC 18C (percentage difference (US1A:US1B))||3|-15|
73994198|NCT00474526|147534395|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||TWO_SIDED|95.0|-4.0|11.0|||ANOVA|||PnC 19F (percentage difference (US1A:US1B))||11|-4|
73994199|NCT00474526|147534395|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-10.0|5.0|||ANOVA|||PnC 239F (percentage difference (US1A:US1B))||5|-10|
73994200|NCT00474526|147534396|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.61|1.02|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio LA1A:LA1B)||1.02|0.61|
73994201|NCT00474526|147534396|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.81|||||TWO_SIDED|95.0|0.54|1.2|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA1A:LA1B)||1.2|0.54|
73994202|NCT00474526|147534396|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||TWO_SIDED|95.0|0.58|0.94|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA1A:LA1B)||0.94|0.58|
73994203|NCT00474526|147534396|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.65|||||TWO_SIDED|95.0|0.51|0.82|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA1A:LA1B)||0.82|0.51|
73994204|NCT00474526|147534396|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.78|||||TWO_SIDED|95.0|0.6|1.01|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA1A:LA1B)||1.01|0.6|
73994205|NCT00474526|147534396|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.56|1.04|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA1A:LA1B)||1.04|0.56|
73994206|NCT00474526|147534396|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||TWO_SIDED|95.0|0.54|1.01|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA1A:LA1B)||1.01|0.54|
73994207|NCT00474526|147534397|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-9.6|5.2|||ANOVA|||PnC 4 (percentage difference (LA1A - LA1B))||5.2|-9.6|
73994208|NCT00474526|147534397|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-11.9|7.3|||ANOVA|||PnC 6B (percentage difference (LA1A - LA1B))||7.3|-11.9|
73994209|NCT00474526|147534397|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||TWO_SIDED|95.0|-10.9|4.3|||ANOVA|||PnC 9V (percentage difference (LA1A - LA1B))||4.3|-10.9|
73994210|NCT00474526|147534397|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-5.6|2.7|||ANOVA|||PnC 14 (percentage difference (LA1A - LA1B))||2.7|-5.6|
73994211|NCT00474526|147534397|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-14.0|||||TWO_SIDED|95.0|-24.1|-5.6|||ANOVA|||PnC 18C (percentage difference (LA1A - LA1B))||-5.6|-24.1|
73994212|NCT00474526|147534397|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||TWO_SIDED|95.0|-11.6|5.2|||ANOVA|||PnC 19F (percentage difference (LA1A - LA1B))||5.2|-11.6|
73994213|NCT00474526|147534397|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|0.0|||||TWO_SIDED|95.0|-7.0|7.0|||ANOVA|||PnC 23F (percentage difference (LA1A - LA1B))||7|-7|
73994214|NCT00474526|147534398|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A/GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.05|||||TWO_SIDED|95.0|0.86|1.27|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA3A:LA3B)||1.27|0.86|
74090154|NCT01763918|147733537|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.15|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-65.83|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.46|-65.83|<0.001
73994215|NCT00474526|147534398|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.75|1.18|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA3A:LA3B)||1.18|0.75|
73994216|NCT00474526|147534398|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.11|||||TWO_SIDED|95.0|0.88|1.4|||ANOVA|||PT (Post-vaccination GMC; group ratio LA3A:LA3B)||1.4|0.88|
73994217|NCT00474526|147534398|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.14|||||TWO_SIDED|95.0|0.9|1.44|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA3A:LA3B)||1.44|0.9|
73994218|NCT00474526|147534398|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.21|||||TWO_SIDED|95.0|0.92|1.59|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA3A:LA3B||1.59|0.92|
73994219|NCT00474526|147534398|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.63|1.16|||ANOVA|||Hib (Post-vaccination GMC; group ratio LA3A:LA3B)||1.16|0.63|
73994220|NCT00474526|147534399|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0||||||95.0|-4.2|5.4|||ANOVA|||Diphtheria (percentage difference (LA3A - LA3B))||5.4|-4.2|
73994221|NCT00474526|147534399|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||TWO_SIDED|95.0|-4.2|5.4|||ANOVA|||Tetanus (percentage difference (LA3A - LA3B))||5.4|-4.2|
73994222|NCT00474526|147534399|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|6.0||||||95.0|-3.6|15.2|||ANOVA|||PT (percentage difference (LA3A - LA3B))||15.2|-3.6|
73994223|NCT00474526|147534399|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|-1.0|||||TWO_SIDED|95.0|-10.2|8.2|||ANOVA|||FHA (percentage difference (LA3A - LA3B))||8.2|-10.2|
73994224|NCT00474526|147534399|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|2.0|||||TWO_SIDED|95.0|-7.2|10.6|||ANOVA|||Pertactin (percentage difference (LA3A - LA3B))||10.6|-7.2|
73994225|NCT00474526|147534399|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.1|3.6|||ANOVA|||Hib (≥ 0.15 μg/mL) (percentage difference (LA3A - LA3B))||3.6|-3.1|
73994226|NCT00474526|147534399|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.2|5.3|||ANOVA|||Hib (≥1.0 μg/mL) (percentage difference (LA3A - LA3B))||5.3|-2.2|
73994227|NCT04546217|147534403|SUPERIORITY|Since this is a descriptive analysis, no power calculation was conducted.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
73994228|NCT04546217|147534404|OTHER|Since this is a descriptive analysis, no power calculation was conducted.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
74035807|NCT00960934|147624166|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.12||||0.333|TWO_SIDED|95.0|-0.6|2.83||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.83|-0.60|0.333
74035808|NCT00960934|147624166|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.35||||0.823|TWO_SIDED|95.0|-1.14|1.84||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.84|-1.14|0.823
74039712|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0015|TWO_SIDED|95.0|1.2|2.2|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.20|0.0015
73994229|NCT04546217|147534405|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
73994230|NCT04546217|147534406|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
73994231|NCT04546217|147534407|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
73994232|NCT04546217|147534408|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
73994233|NCT01251770|147534417|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||Serum Sodium difference at the beginning||||0.030
73994234|NCT01251770|147534417|SUPERIORITY_OR_OTHER|||||||0.871||95.0|||||t-test, 2 sided|||Serum Sodium at the end of the study||||0.871
73994235|NCT01251770|147534418|SUPERIORITY_OR_OTHER|||||||0.895|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.895
73994236|NCT01888874|147534433|SUPERIORITY||Difference in percentage rates|11.9||||0.1236|TWO_SIDED|95.0|-3.1|26.9|||Regression, Logistic|P-value has been corrected for multiplicity according to Hommel's closed-testing method.||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||26.9|-3.1|0.1236
73994237|NCT01888874|147534433|SUPERIORITY||Difference in percentage rates|19.3||||0.0435|TWO_SIDED|95.0|4.7|34.0||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||34|4.7|0.0435
73994238|NCT01888874|147534433|SUPERIORITY||Difference in percentage rates|24.4||||0.0068|TWO_SIDED|95.0|10.1|38.8||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||38.8|10.1|0.0068
73994239|NCT01888874|147534433|SUPERIORITY||Difference in percentage rates|12.8||||0.1236|TWO_SIDED|95.0|-2.0|27.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||27.6|-2|0.1236
73994240|NCT01888874|147534433|SUPERIORITY||Difference in percentage rates|15.8||||0.1056|TWO_SIDED|95.0|1.0|30.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||30.6|1|0.1056
73994241|NCT01888874|147534433|SUPERIORITY||Difference in percentage rates|34.4|||<|0.0001|TWO_SIDED|95.0|20.7|48.1||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||48.1|20.7|< 0.0001
73994242|NCT04052425|147534472|SUPERIORITY||Odds Ratio (OR)|5.28|||<|0.0001|TWO_SIDED|95.0|2.341|11.903||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||11.903|2.341|< 0.0001
73994243|NCT04052425|147534473|SUPERIORITY||Odds Ratio (OR)|5.18|||<|0.0001|TWO_SIDED|95.0|2.831|9.482||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.482|2.831|< 0.0001
73994244|NCT04052425|147534474|SUPERIORITY||Odds Ratio (OR)|8.49||||0.0038|TWO_SIDED|95.0|1.997|36.048||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||36.048|1.997|0.0038
73994245|NCT04052425|147534475|SUPERIORITY||Odds Ratio (OR)|4.93||||0.002|TWO_SIDED|95.0|1.795|13.566||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||13.566|1.795|0.0020
73994246|NCT04052425|147534476|SUPERIORITY||Odds Ratio (OR)|9.53||||0.0002|TWO_SIDED|95.0|2.9|31.29||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||31.290|2.900|0.0002
73994247|NCT04052425|147534477|SUPERIORITY||least squares mean difference|-19.3|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-27.05|-11.64||Response Variable = Treatment + Stratification Factors (Skin Type Fitzpatrick scale Type I, II versus Type III, IV, V, and VI, Region North America/Europe) + Baseline|ANCOVA|||||-11.64|-27.05|< 0.0001
73994248|NCT04052425|147534480|SUPERIORITY||Odds Ratio (OR)|5.56|||<|0.0001|TWO_SIDED|95.0|3.226|9.578||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.578|3.226|< 0.0001
74090155|NCT01763918|147733537|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.55|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-71.27|-59.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-59.83|-71.27|<0.001
73994249|NCT04052425|147534482|SUPERIORITY||least squares mean difference|-30.61|STANDARD_ERROR_OF_MEAN|4.28|<|0.0001|TWO_SIDED|95.0|-39.03|-22.19|||mixed-effect model; repeated measurement|||||-22.19|-39.03|<0.0001
73994250|NCT04052425|147534485|SUPERIORITY||least squares mean difference|-16.98|STANDARD_ERROR_OF_MEAN|3.2|<|0.0001|TWO_SIDED|95.0|-23.28|-10.68|||mixed-effect model; repeated measurement|||||-10.68|-23.28|<0.0001
73994251|NCT04052425|147534487|SUPERIORITY||least squares mean difference|-9.07|STANDARD_ERROR_OF_MEAN|2.49||0.0003|TWO_SIDED|95.0|-13.96|-4.18|||mixed-effect model; repeated measurement|||||-4.18|-13.96|0.0003
73994252|NCT04052425|147534489|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.746|5.307||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI25||5.307|1.746|< 0.0001
73994253|NCT04052425|147534489|SUPERIORITY||Odds Ratio (OR)|2.3||||0.2921|TWO_SIDED|95.0|0.489|10.823||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI75||10.823|0.489|0.2921
73994254|NCT04052425|147534489|SUPERIORITY||Odds Ratio (OR)|0.49||||||||||The p value was not evaluable because the response rate in the vehicle group was too low.||||T-VASI90||||
73994255|NCT04052425|147534492|SUPERIORITY||least squares mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.48||0.497|TWO_SIDED|95.0|-1.26|0.62|||mixed-effect model; repeated measurement|||||0.62|-1.26|0.4970
73994256|NCT01189110|147534534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81|STANDARD_ERROR_OF_MEAN|0.42||0.74|TWO_SIDED|95.0|0.23|2.83|||Chi-squared|||A two-proportion z-test was used to compare the proportion of self-reported abstinence at 3 weeks between groups.||2.83|0.23|0.74
73994257|NCT01732549|147534535|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.0315||||||Log-rank test adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). Two-sided p-value.|Log Rank|||Stratified\[a\]||||=0.0315
73994258|NCT01732549|147534535|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.0344|||||||Log Rank|||Unstratified\[b\]||||=0.0344
73994259|NCT01732549|147534536|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.443|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.4430
73994260|NCT01732549|147534537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5219|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||0.5219
73994261|NCT01732549|147534538|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.5442|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.5442
73994262|NCT01732549|147534539|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.112|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.1120
73994263|NCT01732549|147534540|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2491|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use (or not) \& region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.2491
73994264|NCT00584077|147534543|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||Each subject served as their own control as a comparison of the airway innervated (contralateral native lung) with the denervated airway (allograft)||||<0.01
73994265|NCT00584077|147534544|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value was adjusted for multiple comparisons using Bonferroni test|ANOVA|||For the cross-sectional and longitudinal groups, a comparison of cough frequency after airway irritation of the main carina, and the proximal and distal anastomotic sites was performed using one-way analysis of variance with Bonferroni test. In the longitudinal cohort, a comparison of the cough frequencies at different airway sites at 1.5 and 12 months was performed using one-way analysis of variance with Bonferroni test.||||<0.01
73994266|NCT00447590|147534551|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||2-sided Exact Binomial Test|||p-Value is from a 2-sided exact binomial test to test the null hypothesis that 30% of subjects have at least 30% EWL.||||<0.0001
73994267|NCT04079634|147534562|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
73994268|NCT02103114|147534565|EQUIVALENCE|T1 (Baseline)||||||0.982|||||||t-test, 2 sided|||||||0.982
73994269|NCT02103114|147534565|EQUIVALENCE|T2 (30 minutes after study drug)|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73994270|NCT02103114|147534565|EQUIVALENCE|T3 (30 minutes on CPB)||||||0.001|||||||t-test, 2 sided|||||||0.001
73994271|NCT02103114|147534565|EQUIVALENCE|T5 (Arrival in ICU)||||||0.003|||||||t-test, 2 sided|||||||0.003
73994272|NCT02103114|147534565|EQUIVALENCE|T6 (POD 2)||||||0.84|||||||t-test, 2 sided|||||||0.840
73994273|NCT02103114|147534565|EQUIVALENCE|T7 (POD 4)||||||0.475|||||||t-test, 2 sided|||||||0.475
73994274|NCT02103114|147534566|EQUIVALENCE|T4 (just prior to coming off of CPB)||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
73994275|NCT02103114|147534567|EQUIVALENCE|T1 (Baseline)||||||0.855|||||||Wilcoxon (Mann-Whitney)|||||||0.855
73994276|NCT02103114|147534567|EQUIVALENCE|T5 (Arrival in ICU)||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
73994277|NCT02103114|147534567|EQUIVALENCE|T6 (POD 2)||||||0.313|||||||Wilcoxon (Mann-Whitney)|||||||0.313
73994278|NCT02103114|147534567|EQUIVALENCE|T7 (POD 4)||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
73994279|NCT02103114|147534570|EQUIVALENCE|T1 (Baseline) to T5 (Arrival in ICU)||||||0.056|||||||Wilcoxon (Mann-Whitney)|||||||0.056
73994280|NCT02103114|147534571|EQUIVALENCE|T1 (Baseline) to T5 (Arrival in ICU)||||||0.545|||||||Wilcoxon (Mann-Whitney)|||||||0.545
73994281|NCT02103114|147534573|EQUIVALENCE|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||||0.757|||||||Wilcoxon (Mann-Whitney)|||||||0.757
73994282|NCT02103114|147534576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2741|||||||t-test, 2 sided|24 hour postop Fresh Frozen Plasma exposures||||||0.2741
73876798|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|-10.0||||0.54|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||3.1|-23.1|0.540
73994283|NCT02103114|147534576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0351|||||||t-test, 2 sided|24 hour postop Platelet exposures||||||0.0351
73994284|NCT02103114|147534576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||t-test, 2 sided|24 hour postop Cryoprecipitate exposures||||||0.073
73994285|NCT02103114|147534576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196|||||||t-test, 2 sided|24 hour postop Red Blood Cell exposures||||||0.0196
73994286|NCT02103114|147534577|EQUIVALENCE|protamine time plus 24 hours||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
73994287|NCT02103114|147534579|EQUIVALENCE|24 Hours Post-Operatively||||||0.0004|||||||Fisher Exact|||||||0.0004
73994288|NCT02103114|147534580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.927|||||||t-test, 2 sided|||||||0.927
73994289|NCT02103114|147534581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738|||||||t-test, 2 sided|||||||0.738
73994290|NCT02103114|147534582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|||||||Fisher Exact|||||||0.231
73994291|NCT02103114|147534583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.661|||||||Fisher Exact|||||||0.661
73994292|NCT02103114|147534585|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||||||1.0
73994293|NCT02103114|147534586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.342|||||||Fisher Exact|||||||0.342
73994294|NCT02103114|147534587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961|||||||t-test, 2 sided|||||||0.961
73994295|NCT03933462|147534588|SUPERIORITY|"Categorical preference endpoints that answered at the final visit (e.g., Which device do you prefer?) were analyzed with a One-sample Binomial Test that compared the observed proportion to a 50/50 split."|||||<|0.001|||||||One Sample Binomial|||||||<0.001
73994296|NCT01937975|147534597|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.87|1.09|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.09|0.87|
73994297|NCT01937975|147534597|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.58|1.25|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.25|0.58|
73994298|NCT01937975|147534597|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.83|||||TWO_SIDED|90.0|0.56|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.22|0.56|
73994299|NCT01937975|147534597|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.65|||||TWO_SIDED|90.0|1.09|2.49|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.49|1.09|
73994300|NCT01937975|147534598|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.81|1.19|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.19|0.81|
73994301|NCT01937975|147534598|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.54|1.16|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.16|0.54|
73994302|NCT01937975|147534598|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.78|||||TWO_SIDED|90.0|0.53|1.14|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.14|0.53|
73994303|NCT01937975|147534598|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.6|||||TWO_SIDED|90.0|1.06|2.42|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.42|1.06|
73994304|NCT01937975|147534599|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.96|||||TWO_SIDED|90.0|0.75|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.22|0.75|
73994305|NCT01937975|147534599|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.57|1.48|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.48|0.57|
73994306|NCT01937975|147534599|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.54|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.42|0.54|
73994307|NCT01937975|147534599|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|0.99|2.77|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.77|0.99|
73994308|NCT01937975|147534602|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.92|1.15|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.15|0.92|
73994309|NCT01937975|147534602|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.8|1.73|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.73|0.80|
73994310|NCT01937975|147534602|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.21|||||TWO_SIDED|90.0|0.82|1.78|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.78|0.82|
73994311|NCT01937975|147534602|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.61|||||TWO_SIDED|90.0|0.4|0.92|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||0.92|0.40|
73994312|NCT01937975|147534603|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.63|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|||1.42|0.63|
73994313|NCT01937975|147534603|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.61|||||TWO_SIDED|90.0|0.39|0.94|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|||0.94|0.39|
73994314|NCT01937975|147534604|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.14|||||TWO_SIDED|90.0|1.08|1.21|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.21|1.08|
73994315|NCT01937975|147534604|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.86|||||TWO_SIDED|90.0|0.65|1.14|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.14|0.65|
73994316|NCT01937975|147534604|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.75|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.30|0.75|
73994317|NCT01937975|147534604|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.86|||||TWO_SIDED|90.0|1.38|2.51|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.51|1.38|
73994318|NCT01937975|147534605|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.24|||||TWO_SIDED|90.0|1.17|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.32|1.17|
74090156|NCT01763918|147733538|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-95.2|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-105.1|-85.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-85.2|-105.1|<0.001
73994319|NCT01937975|147534605|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77|||||TWO_SIDED|90.0|0.56|1.06|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.06|0.56|
73994320|NCT01937975|147534605|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.69|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.32|0.69|
73994321|NCT01937975|147534605|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.07|||||TWO_SIDED|90.0|1.46|2.93|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.93|1.46|
73994322|NCT01937975|147534606|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|1.0|1.26|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.26|1.00|
73994323|NCT01937975|147534606|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.84|||||TWO_SIDED|90.0|0.62|1.13|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.13|0.62|
73994324|NCT01937975|147534606|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.7|1.27|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.27|0.70|
73994325|NCT01937975|147534606|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|1.21|2.28|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.28|1.21|
73994326|NCT01937975|147534609|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.83|0.92|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||0.92|0.83|
73994327|NCT01937975|147534609|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.16|||||TWO_SIDED|90.0|0.88|1.53|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.53|0.88|
73994328|NCT01937975|147534609|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.77|1.34|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.34|0.77|
73994329|NCT01937975|147534609|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.54|||||TWO_SIDED|90.0|0.4|0.72|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||0.72|0.40|
73994330|NCT01937975|147534610|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.7|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|||1.30|0.70|
73994331|NCT01937975|147534610|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.63|||||TWO_SIDED|90.0|0.45|0.89|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|||0.89|0.45|
73994332|NCT00706654|147534612|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority of was performed using a 95% confidence interval (CI, 2-sided) for the difference in the estimated percentage of patients meeting exacerbation of psychotic symptoms/impending relapse criteria by the end of Week 26. Non-inferiority was considered confirmed if the upper bound of the 2-sided 95% CI was below the predefined margin, 11.5%.|Mean Difference (Final Values)|-0.64||||0.7871|TWO_SIDED|95.0|-5.26|3.99|||z-statistics||The 95% CI of the difference in proportions of subjects with impending relapse events between aripiprazole IM depot 300 or 400 mg mg and oral aripiprazole were provided using the pooled SE with assumption of normality of the estimated difference.|Sample sizes were estimated to achieve 93% power for the primary non-inferiority 2-sided comparison at 0.05 significance using large sample normal approximations for the distribution of the difference in binomial proportions. The assumed proportion of impending relapse at or before Week 26 for the oral aripiprazole 10-30 mg arm was 18% and the predefined non-inferiority margin was 11.5%. The sample size was projected to be 260 each for the IM depot 300 or 400 mg and oral 10-30 mg arms.||3.99|-5.26|0.7871
73994333|NCT00706654|147534612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.68||||0.0006|TWO_SIDED|95.0|-23.09|-6.27||Once non-inferiority was declared, superiority of depot 300/400 mg over depot 25/50 mg was tested by the difference between the proportion of subjects experiencing impending relapse by the end of Week 26 (2-sided 0.05 significance level z-statistic).|z-statistics|The same method was used to compare IM depot 300 or 400 mg with IM depot 25 or 50 mg in the estimated proportion of subjects with impending relapse.||For the superiority comparison (assay sensitivity analysis) of IM depot 300 or 400 mg to IM depot 25 or 50 mg, on a 2:1 randomization, sample sizes of 260 and 130, respectively, were calculated to provide about 95% power at the 0.05 significance level (2-sided). A superiority margin of 17% was assumed.||-6.27|-23.09|0.0006
73994334|NCT00706654|147534614|SUPERIORITY_OR_OTHER|||||||0.875||95.0|||||z-statistics|||||||0.8750
73994335|NCT00706654|147534614|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||z-statistics|||||||0.0001
73994336|NCT00706654|147534615|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||z-statistics|||||||0.3700
73994337|NCT00706654|147534615|SUPERIORITY_OR_OTHER|||||||0.1097||95.0|||||z-statistics|||||||0.1097
73994338|NCT00594022|147534619|SUPERIORITY_OR_OTHER|||||||0.1275|||||||t-test, 1 sided|||||||.1275
73994339|NCT03321253|147534657|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
73994340|NCT00664534|147534685|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin is defined as 0.4%. If the upper 95%CI for difference in LSMeans is below 0.4% then MIX arm will be declared noninferior to GLAR arm|Least squares mean difference|-0.14|||||TWO_SIDED|95.0|-0.42|0.13|||||Least squares mean difference = (Premix insulin Lispro -Glargine)|||0.13|-0.42|
74090157|NCT01763918|147733538|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-97.4|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-107.1|-87.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-87.7|-107.1|<0.001
74035809|NCT00960934|147624166|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.93||||0.457|TWO_SIDED|95.0|-0.75|2.61||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.61|-0.75|0.457
74035810|NCT00960934|147624166|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.823|TWO_SIDED|95.0|-1.17|1.5||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.50|-1.17|0.823
74035811|NCT00960934|147624167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.8|||<|0.001||95.0|56.5|80.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||80.0|56.5|<0.001
74090158|NCT01763918|147733539|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-92.9|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-102.9|-82.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-82.8|-102.9|<0.001
73994341|NCT00664534|147534687|SUPERIORITY_OR_OTHER||Least squares mean difference|0.05|||||TWO_SIDED|95.0|-0.18|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 16 weeks|||0.29|-0.18|
73994342|NCT00664534|147534687|SUPERIORITY_OR_OTHER||Least squares mean difference|0.04|||||TWO_SIDED|95.0|-0.22|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 32 weeks|||0.29|-0.22|
73994343|NCT00664534|147534687|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.08|||||TWO_SIDED|95.0|-0.33|0.18|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 48 weeks|||0.18|-0.33|
74035812|NCT00960934|147624167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.1|||<|0.001|TWO_SIDED|95.0|39.6|65.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||65.2|39.6|<0.001
73994344|NCT00664534|147534688|SUPERIORITY_OR_OTHER|||||||0.2127||95.0||||P-value is for Week 16 HbA1c \<=7.0%.|Chi-squared|||||||0.2127
73994345|NCT00664534|147534688|SUPERIORITY_OR_OTHER|||||||0.3281||95.0||||P-value is for Week 16 HbA1c \<=6.5%|Chi-squared|||||||0.3281
73994346|NCT00664534|147534688|SUPERIORITY_OR_OTHER|||||||0.2812||95.0||||P-value is for Week 32 HbA1c \<=7.0%|Chi-squared|||||||0.2812
73994347|NCT00664534|147534688|SUPERIORITY_OR_OTHER|||||||0.6963||95.0||||P-value is for Week 32 HbA1c \<=6.5%|Chi-squared|||||||0.6963
73994348|NCT00664534|147534688|SUPERIORITY_OR_OTHER|||||||0.0643||95.0||||P-value is for Week 48 HbA1c \<=7.0%|Chi-squared|||||||0.0643
73994349|NCT00664534|147534688|SUPERIORITY_OR_OTHER|||||||0.2524||95.0||||P-value is for Week 48 HbA1c \<=6.5%|Chi-squared|||||||0.2524
73994350|NCT00664534|147534690|SUPERIORITY_OR_OTHER|||||||0.6615||95.0||||P-value for Baseline|Wilcoxon (Mann-Whitney)|||||||0.6615
73994351|NCT00664534|147534690|SUPERIORITY_OR_OTHER|||||||0.9798||95.0||||P-value is for Week 16|Wilcoxon (Mann-Whitney)|||||||0.9798
73994352|NCT00664534|147534690|SUPERIORITY_OR_OTHER|||||||0.6169||95.0||||P-value for Week 32|Wilcoxon (Mann-Whitney)|||||||0.6169
73994353|NCT00664534|147534690|SUPERIORITY_OR_OTHER|||||||0.7834||95.0||||P-value for Week 48|Wilcoxon (Mann-Whitney)|||||||0.7834
73994354|NCT00664534|147534692|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.89|0.7|||||Least Squares Mean Difference = Premix Insulin Lispro minus Glargine.|||0.70|-0.89|
73994355|NCT00664534|147534693|SUPERIORITY_OR_OTHER|||||||0.4935||95.0|||||Fisher Exact|||||||0.4935
73994356|NCT03041792|147534702|SUPERIORITY||Least Square Mean Difference|-235.75|STANDARD_ERROR_OF_MEAN|43.13||0|TWO_SIDED|95.0|-322.25|-149.25||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 4||-149.25|-322.25|0.0000
74035813|NCT00960934|147624167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.6|||<|0.001|TWO_SIDED|95.0|17.6|42.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||42.4|17.6|<0.001
74035814|NCT00960934|147624167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.1|||<|0.001|TWO_SIDED|95.0|17.0|42.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||42.0|17.0|<0.001
74035815|NCT00960934|147624167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.254|TWO_SIDED|95.0|-4.1|14.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||14.4|-4.1|0.254
74035816|NCT00960934|147624168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.6|||<|0.001|TWO_SIDED|95.0|34.9|60.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||60.0|34.9|<0.001
73876799|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|-3.1||||1|TWO_SIDED|95.0|-9.2|2.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||2.9|-9.2|1.000
73876800|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|5.7||||0.614|TWO_SIDED|95.0|-5.6|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||17.0|-5.6|0.614
73876801|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|1.2||||1|TWO_SIDED|95.0|-9.1|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||11.5|-9.1|1.000
73876802|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|0.9||||1|TWO_SIDED|95.0|-15.0|16.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||16.8|-15.0|1.000
73876803|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|14.4||||0.135|TWO_SIDED|95.0|-2.5|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-2.5|0.135
73876804|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-14.1|12.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||12.1|-14.1|1.000
73876805|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
73876806|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|4.5||||1|TWO_SIDED|95.0|-11.3|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||20.3|-11.3|1.000
73876807|NCT02365649|147294846|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
73876808|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|15.0||||0.669|TWO_SIDED|95.0|-21.9|51.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||51.9|-21.9|0.669
73876809|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|15.0||||0.343|TWO_SIDED|95.0|-15.2|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||45.2|-15.2|0.343
73876810|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|-20.0||||0.442|TWO_SIDED|95.0|-57.2|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||17.2|-57.2|0.442
73876811|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-23.4|32.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||32.2|-23.4|1.000
73876812|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|5.0||||0.601|TWO_SIDED|95.0|-13.6|23.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||23.5|-13.6|0.601
73876813|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|1.8||||1|TWO_SIDED|95.0|-18.2|21.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||21.7|-18.2|1.000
73994357|NCT03041792|147534702|SUPERIORITY||Least Square Mean Difference|-243.63|STANDARD_ERROR_OF_MEAN|47.6||0|TWO_SIDED|95.0|-339.1|-148.15||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 5||-148.15|-339.10|0.0000
74039713|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.45|2.63|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.63|1.45|<.0001
74090159|NCT01763918|147733539|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-91.3|STANDARD_ERROR_OF_MEAN|6.3|<|0.001|TWO_SIDED|95.0|-103.8|-78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-78.9|-103.8|<0.001
73876814|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|16.5||||0.301|TWO_SIDED|95.0|-14.5|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||47.5|-14.5|0.301
73994358|NCT03041792|147534707|SUPERIORITY||Least Square Mean Difference|-859.58|STANDARD_ERROR_OF_MEAN|167.76||0|TWO_SIDED|95.0|-1196.1|-523.1||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 4||-523.10|-1196.1|0.0000
73994359|NCT03041792|147534707|SUPERIORITY||Least Square Mean Difference|-928.56|STANDARD_ERROR_OF_MEAN|193.8||0|TWO_SIDED|95.0|-1317.3|-539.86||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 5||-539.86|-1317.3|0.0000
74090160|NCT01763918|147733540|SUPERIORITY_OR_OTHER||Treatment Difference|65.1|||<|0.001|TWO_SIDED|95.0|52.8|73.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||73.4|52.8|<0.001
74090161|NCT01763918|147733540|SUPERIORITY_OR_OTHER||Treatment Difference|78.5|||<|0.001|TWO_SIDED|95.0|66.9|85.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||85.1|66.9|<0.001
73876815|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|14.5||||0.256|TWO_SIDED|95.0|-10.3|39.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||39.4|-10.3|0.256
73876816|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|1.5||||0.917|TWO_SIDED|95.0|-26.5|29.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.5|-26.5|0.917
73876817|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|-20.2||||1|TWO_SIDED|95.0|-37.5|-2.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||-2.5|-37.5|1.000
73994360|NCT03041792|147534708|SUPERIORITY||Least Square Mean Difference|4.95|STANDARD_ERROR_OF_MEAN|2.16||0.0263|TWO_SIDED|95.0|0.61|9.29|||Mixed Models Analysis|||Visit 4||9.29|0.61|0.0263
73994361|NCT03041792|147534708|SUPERIORITY||Least Square Mean Difference|5.35|STANDARD_ERROR_OF_MEAN|2.06||0.0121|TWO_SIDED|95.0|1.22|9.48|||Mixed Models Analysis|||Visit 5||9.48|1.22|0.0121
73994362|NCT03041792|147534709|SUPERIORITY||Least Square Mean Difference|3.98|STANDARD_ERROR_OF_MEAN|2.91||0.1768|TWO_SIDED|95.0|-1.85|9.82|||Mixed Models Analysis|||Satiety (Visit 4)||9.82|-1.85|0.1768
73994363|NCT03041792|147534709|SUPERIORITY||Least Square Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|2.13||0.1137|TWO_SIDED|95.0|-0.85|7.7|||Mixed Models Analysis|||Satiety (Visit 5)||7.70|-0.85|0.1137
73994364|NCT03041792|147534709|SUPERIORITY||Least Square Mean Difference|2.85|STANDARD_ERROR_OF_MEAN|2.12||0.1858|TWO_SIDED|95.0|-1.41|7.11|||Mixed Models Analysis|||Fullness (Visit 4)||7.11|-1.41|0.1858
73994365|NCT03041792|147534709|SUPERIORITY||Least Square Mean Difference|1.41|STANDARD_ERROR_OF_MEAN|2.22||0.5288|TWO_SIDED|95.0|-3.05|5.86|||Mixed Models Analysis|||Fullness (Visit 5)||5.86|-3.05|0.5288
73994366|NCT03041792|147534709|SUPERIORITY||Least Square Mean Difference|-8.46|STANDARD_ERROR_OF_MEAN|2.91||0.0054|TWO_SIDED|95.0|-14.3|-2.61|||Mixed Models Analysis|||Prospective food consumption (Visit 4)||-2.61|-14.30|0.0054
73994367|NCT03041792|147534709|SUPERIORITY||Least Square Mean Difference|-9.78|STANDARD_ERROR_OF_MEAN|3.75||0.0117|TWO_SIDED|95.0|-17.29|-2.27|||Mixed Models Analysis|||Prospective food consumption (Visit 5)||-2.27|-17.29|0.0117
73994368|NCT03041792|147534709|SUPERIORITY||Least Square Mean Difference|-6.58|STANDARD_ERROR_OF_MEAN|2.44||0.0093|TWO_SIDED|95.0|-11.48|-1.69|||Mixed Models Analysis|||Hunger (Visit 4)||-1.69|-11.48|0.0093
73994369|NCT03041792|147534709|SUPERIORITY||Least Square Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|2.86||0.0296|TWO_SIDED|95.0|-12.12|-0.66|||Mixed Models Analysis|||Hunger (Visit 5)||-0.66|-12.12|0.0296
73994370|NCT03041792|147534710|SUPERIORITY||Least Square Mean Difference|35.56|STANDARD_ERROR_OF_MEAN|52.46||0.5008|TWO_SIDED|95.0|-69.64|140.76|||Mixed Models Analysis|||AUC0-60min (Visit 4)||140.76|-69.64|0.5008
73994371|NCT03041792|147534710|SUPERIORITY||Least Square Mean Difference|106.15|STANDARD_ERROR_OF_MEAN|48.95||0.0348|TWO_SIDED|95.0|7.86|204.44|||Mixed Models Analysis|||AUC0-60min (Visit 5)||204.44|7.86|0.0348
73994372|NCT03041792|147534710|SUPERIORITY||Least Square Mean Difference|214.24|STANDARD_ERROR_OF_MEAN|129.48||0.104|TWO_SIDED|95.0|-45.59|474.07|||Mixed Models Analysis|||AUC0-300min (Visit 4)||474.07|-45.59|0.1040
73994373|NCT03041792|147534710|SUPERIORITY||Least Square Mean Difference|348.43|STANDARD_ERROR_OF_MEAN|138.29||0.0152|TWO_SIDED|95.0|70.2|626.66|||Mixed Models Analysis|||AUC0-300min (Visit 5)||626.66|70.20|0.0152
73994374|NCT00305344|147534835|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Fisher Exact|||Null hypothesis: there will be no difference between AUC C-peptide at baseline and 1 or 2 years post cord blood infusion||||>0.05
73994375|NCT02209181|147534856|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.38|STANDARD_ERROR_OF_MEAN|2.522|<|0.001|TWO_SIDED|95.0|11.42|21.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.35|11.42|<0.001
73876818|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|-5.7||||0.697|TWO_SIDED|95.0|-28.8|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||17.3|-28.8|0.697
73994376|NCT02209181|147534856|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.58|STANDARD_ERROR_OF_MEAN|2.503||0.068|TWO_SIDED|95.0|-0.35|9.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||9.51|-0.35|0.068
73994377|NCT02209181|147534856|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.2|STANDARD_ERROR_OF_MEAN|2.531|<|0.001|TWO_SIDED|95.0|11.21|21.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.18|11.21|<0.001
73994378|NCT02209181|147534856|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.81|STANDARD_ERROR_OF_MEAN|2.503|<|0.001|TWO_SIDED|95.0|-16.73|-6.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-6.88|-16.73|<0.001
73994379|NCT02209181|147534856|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|2.531||0.941|TWO_SIDED|95.0|-5.17|4.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.80|-5.17|0.941
73994380|NCT02209181|147534857|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.15||0.448|TWO_SIDED|95.0|-0.19|0.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.42|-0.19|0.448
73994381|NCT02209181|147534857|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.15||0.618|TWO_SIDED|95.0|-0.38|0.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.22|-0.38|0.618
74090162|NCT01763918|147733541|SUPERIORITY_OR_OTHER||Treatment Difference|66.3|||<|0.001|TWO_SIDED|95.0|53.7|74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use||||74.6|53.7|<0.001
73994382|NCT02209181|147534857|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15||0.621|TWO_SIDED|95.0|-0.23|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.23|0.621
73994383|NCT02209181|147534857|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.207|TWO_SIDED|95.0|-0.49|0.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.11|-0.49|0.207
73994384|NCT02209181|147534857|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.794|TWO_SIDED|95.0|-0.34|0.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.26|-0.34|0.794
73994385|NCT02209181|147534858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|0.82|1.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.86|0.82|<0.001
73994386|NCT02209181|147534858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.26||0.42|TWO_SIDED|95.0|-0.3|0.72||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.72|-0.30|0.420
73994387|NCT02209181|147534858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.26||0.083|TWO_SIDED|95.0|-0.06|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-0.06|0.083
73994388|NCT02209181|147534858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.64|-0.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.62|-1.64|<0.001
73994389|NCT02209181|147534858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.4|-0.37||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.37|-1.40|<0.001
73994390|NCT02209181|147534859|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.93|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|2.28|3.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.59|2.28|<0.001
73994391|NCT02209181|147534859|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.33||0.058|TWO_SIDED|95.0|-0.02|1.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.29|-0.02|0.058
73994392|NCT02209181|147534859|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.23|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|0.57|1.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.89|0.57|<0.001
73994393|NCT02209181|147534859|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-2.96|-1.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.65|-2.96|<0.001
73994394|NCT02209181|147534859|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.37|-1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.04|-2.37|<0.001
73994395|NCT02209181|147534860|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|3.01|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.46|3.01|<0.001
73994396|NCT02209181|147534860|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.36||0.035|TWO_SIDED|95.0|0.06|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.49|0.06|0.035
74035817|NCT00960934|147624168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.9|||<|0.001|TWO_SIDED|95.0|24.1|48.5|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||48.5|24.1|<0.001
74035818|NCT00960934|147624168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.2||||0.001|TWO_SIDED|95.0|7.7|28.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||28.7|7.7|0.001
73994397|NCT02209181|147534860|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.94|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|1.21|2.67||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.67|1.21|<0.001
73994398|NCT02209181|147534860|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.96|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-3.68|-2.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.24|-3.68|<0.001
73994399|NCT02209181|147534860|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.52|-1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.07|-2.52|<0.001
73994400|NCT02209181|147534861|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.99|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|3.21|4.77||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.77|3.21|<0.001
73994401|NCT02209181|147534861|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.39||0.028|TWO_SIDED|95.0|0.09|1.64||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.64|0.09|0.028
73994402|NCT02209181|147534861|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.48|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.7|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.26|1.70|<0.001
73994403|NCT02209181|147534861|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-3.9|-2.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.35|-3.90|<0.001
73994404|NCT02209181|147534861|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.29|-0.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.73|-2.29|<0.001
74039714|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0164|TWO_SIDED|95.0|1.06|1.86|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|1.06|0.0164
74039715|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2857|TWO_SIDED|95.0|0.89|1.51|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.51|0.89|0.2857
74039716|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0149|TWO_SIDED|95.0|1.07|1.8|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.80|1.07|0.0149
73876819|NCT02365649|147294847|SUPERIORITY||Risk Difference (RD)|-20.0||||0.126|TWO_SIDED|95.0|-37.5|-2.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||-2.5|-37.5|0.126
73876820|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|10.0||||0.691|TWO_SIDED|95.0|-30.8|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.8|-30.8|0.691
73994405|NCT02209181|147534862|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|2.92|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.65|2.92|<0.001
73994406|NCT02209181|147534862|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.44||0.021|TWO_SIDED|95.0|0.16|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.88|0.16|0.021
73994407|NCT02209181|147534862|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|2.19|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.93|2.19|<0.001
73994408|NCT02209181|147534862|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.63|-1.91||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.91|-3.63|<0.001
73994409|NCT02209181|147534862|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.44||0.104|TWO_SIDED|95.0|-1.59|0.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.15|-1.59|0.104
73994410|NCT02209181|147534863|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|2.18|4.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.07|2.18|<0.001
73994411|NCT02209181|147534863|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.98|STANDARD_ERROR_OF_MEAN|0.48||0.041|TWO_SIDED|95.0|0.04|1.92||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.92|0.04|0.041
73994412|NCT02209181|147534863|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.14|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|2.19|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.09|2.19|<0.001
73994413|NCT02209181|147534863|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.15|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.09|-1.21||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.21|-3.09|<0.001
73994414|NCT02209181|147534863|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.48||0.973|TWO_SIDED|95.0|-0.93|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-0.93|0.973
73994415|NCT02209181|147534864|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.87|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.87|3.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.87|1.87|<0.001
73994416|NCT02209181|147534864|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.89|STANDARD_ERROR_OF_MEAN|0.5||0.079|TWO_SIDED|95.0|-0.1|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.88|-0.10|0.079
73994417|NCT02209181|147534864|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.27|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|2.27|4.27||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.27|2.27|<0.001
73994418|NCT02209181|147534864|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.98|-1.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.00|-2.98|<0.001
73994419|NCT02209181|147534864|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.51||0.44|TWO_SIDED|95.0|-0.61|1.4||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.40|-0.61|0.440
73994420|NCT02209181|147534865|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.55|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.52|3.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.57|1.52|<0.001
73994421|NCT02209181|147534865|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.52||0.118|TWO_SIDED|95.0|-0.21|1.83||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.83|-0.21|0.118
73994422|NCT02209181|147534865|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.1|4.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.16|2.10|<0.001
73994423|NCT02209181|147534865|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.75|-0.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.71|-2.75|<0.001
73994424|NCT02209181|147534865|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.52||0.262|TWO_SIDED|95.0|-0.44|1.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.62|-0.44|0.262
73994425|NCT02209181|147534866|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|0.88|2.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.96|0.88|<0.001
73994426|NCT02209181|147534866|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.52||0.271|TWO_SIDED|95.0|-0.45|1.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.61|-0.45|0.271
73994427|NCT02209181|147534866|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.95|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|1.91|3.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.99|1.91|<0.001
73994428|NCT02209181|147534866|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.52||0.011|TWO_SIDED|95.0|-2.37|-0.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.32|-2.37|0.011
73994429|NCT02209181|147534866|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.53||0.052|TWO_SIDED|95.0|-0.01|2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.07|-0.01|0.052
73994430|NCT02209181|147534867|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.25|STANDARD_ERROR_OF_MEAN|0.53||0.018|TWO_SIDED|95.0|0.21|2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.29|0.21|0.018
73994431|NCT02209181|147534867|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.52||0.31|TWO_SIDED|95.0|-0.5|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.56|-0.50|0.310
73994432|NCT02209181|147534867|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|1.76|3.85||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.85|1.76|<0.001
73994433|NCT02209181|147534867|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.52||0.172|TWO_SIDED|95.0|-1.75|0.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.31|-1.75|0.172
73994434|NCT02209181|147534867|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.55|STANDARD_ERROR_OF_MEAN|0.53||0.004|TWO_SIDED|95.0|0.51|2.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.60|0.51|0.004
73994435|NCT02209181|147534868|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.51||0.102|TWO_SIDED|95.0|-0.17|1.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.84|-0.17|0.102
73994436|NCT02209181|147534868|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.51||0.479|TWO_SIDED|95.0|-0.64|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.35|-0.64|0.479
73994437|NCT02209181|147534868|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.85|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.85|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.86|1.85|<0.001
73994438|NCT02209181|147534868|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.51||0.345|TWO_SIDED|95.0|-1.47|0.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-1.47|0.345
73994439|NCT02209181|147534868|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.01|3.02||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.02|1.01|<0.001
73994440|NCT02209181|147534869|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.51||0.338|TWO_SIDED|95.0|-0.52|1.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.51|-0.52|0.338
73994441|NCT02209181|147534869|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.51||0.299|TWO_SIDED|95.0|-0.47|1.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.54|-0.47|0.299
73994442|NCT02209181|147534869|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.72|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.7|3.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.73|1.70|<0.001
73994443|NCT02209181|147534869|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.942|TWO_SIDED|95.0|-0.97|1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.04|-0.97|0.942
73994444|NCT02209181|147534869|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.21|3.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.24|1.21|<0.001
73994445|NCT02209181|147534870|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.51||0.306|TWO_SIDED|95.0|-0.48|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.53|-0.48|0.306
73994446|NCT02209181|147534870|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.51||0.335|TWO_SIDED|95.0|-0.51|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.49|-0.51|0.335
73994447|NCT02209181|147534870|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.78|3.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.80|1.78|<0.001
74035819|NCT00960934|147624168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1||||0.05|TWO_SIDED|95.0|0.0|18.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||18.2|-0.0|0.050
74035820|NCT00960934|147624168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.313|TWO_SIDED|95.0|-8.5|4.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||4.2|-8.5|0.313
74035821|NCT00960934|147624169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.8|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.8|-5.8|>0.999
74035822|NCT00960934|147624169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.7|-5.8|>0.999
74035823|NCT00960934|147624169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.7|-5.8|>0.999
74035824|NCT00960934|147624169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.313|TWO_SIDED|95.0|-4.2|8.6|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||8.6|-4.2|0.313
73994448|NCT02209181|147534870|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.51||0.946|TWO_SIDED|95.0|-1.03|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-1.03|0.946
73994449|NCT02209181|147534870|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.27|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.25|3.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.28|1.25|<0.001
73994450|NCT02209181|147534871|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.51||0.279|TWO_SIDED|95.0|-0.45|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.56|-0.45|0.279
73994451|NCT02209181|147534871|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|0.51||0.292|TWO_SIDED|95.0|-0.46|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.53|-0.46|0.292
73994452|NCT02209181|147534871|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.66|3.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.68|1.66|<0.001
73994453|NCT02209181|147534871|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.51||0.971|TWO_SIDED|95.0|-1.02|0.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.98|-1.02|0.971
73994454|NCT02209181|147534871|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.11|3.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.12|1.11|<0.001
73994455|NCT02209181|147534872|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.329|TWO_SIDED|95.0|-0.5|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-0.50|0.329
73994456|NCT02209181|147534872|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.5||0.531|TWO_SIDED|95.0|-0.68|1.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.31|-0.68|0.531
73994457|NCT02209181|147534872|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.53|3.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.54|1.53|<0.001
73994458|NCT02209181|147534872|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.5||0.722|TWO_SIDED|95.0|-1.17|0.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.81|-1.17|0.722
73994459|NCT02209181|147534872|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.03|3.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.04|1.03|<0.001
74090163|NCT01763918|147733541|SUPERIORITY_OR_OTHER||Treatment Difference|60.9|||<|0.001|TWO_SIDED|95.0|47.6|69.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||69.8|47.6|<0.001
73994460|NCT02209181|147534873|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.5||0.38|TWO_SIDED|95.0|-0.54|1.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.42|-0.54|0.380
73994461|NCT02209181|147534873|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.49||0.767|TWO_SIDED|95.0|-0.83|1.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.12|-0.83|0.767
73994462|NCT02209181|147534873|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.52|3.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.49|1.52|<0.001
73994463|NCT02209181|147534873|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.49||0.557|TWO_SIDED|95.0|-1.27|0.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.68|-1.27|0.557
73994464|NCT02209181|147534873|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.06|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.08|3.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.05|1.08|<0.001
73994465|NCT02209181|147534874|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.55||0.64|TWO_SIDED|95.0|-0.83|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.35|-0.83|0.640
73994466|NCT02209181|147534874|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.55||0.798|TWO_SIDED|95.0|-0.94|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-0.94|0.798
73994467|NCT02209181|147534874|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.32|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.23|3.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.42|1.23|<0.001
73994468|NCT02209181|147534874|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.55||0.829|TWO_SIDED|95.0|-1.2|0.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.96|-1.20|0.829
73994469|NCT02209181|147534874|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.06|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|0.97|3.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.16|0.97|<0.001
73994470|NCT02209181|147534875|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.16||0.117|TWO_SIDED|95.0|-0.06|0.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.06|0.117
73994471|NCT02209181|147534875|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.687|TWO_SIDED|95.0|-0.25|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.25|0.687
73994472|NCT02209181|147534875|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.497|TWO_SIDED|95.0|-0.21|0.43||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.43|-0.21|0.497
73994473|NCT02209181|147534875|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.239|TWO_SIDED|95.0|-0.51|0.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.13|-0.51|0.239
73994474|NCT02209181|147534875|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.376|TWO_SIDED|95.0|-0.46|0.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.18|-0.46|0.376
73994475|NCT02209181|147534876|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.78|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|1.14|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.42|1.14|<0.001
73994476|NCT02209181|147534876|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.32||0.35|TWO_SIDED|95.0|-0.33|0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.94|-0.33|0.350
73994477|NCT02209181|147534876|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.33||0.183|TWO_SIDED|95.0|-0.21|1.08||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.08|-0.21|0.183
73994478|NCT02209181|147534876|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-2.11|-0.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.84|-2.11|<0.001
73994479|NCT02209181|147534876|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.98|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.70|-1.98|<0.001
73994480|NCT02209181|147534877|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|2.94|4.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.61|2.94|<0.001
73994481|NCT02209181|147534877|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.42||0.037|TWO_SIDED|95.0|0.05|1.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.71|0.05|0.037
73994482|NCT02209181|147534877|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.47|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|0.63|2.3||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.30|0.63|<0.001
73994483|NCT02209181|147534877|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.73|-2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.07|-3.73|<0.001
73994484|NCT02209181|147534877|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.15|-1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.47|-3.15|<0.001
73994485|NCT02209181|147534878|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.34|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|3.43|5.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.25|3.43|<0.001
73994486|NCT02209181|147534878|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.46||0.067|TWO_SIDED|95.0|-0.06|1.75||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.75|-0.06|0.067
73994487|NCT02209181|147534878|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.26|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|1.34|3.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.17|1.34|<0.001
73994488|NCT02209181|147534878|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.49|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-4.4|-2.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.59|-4.40|<0.001
73994489|NCT02209181|147534878|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-3.0|-1.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.17|-3.00|<0.001
73994490|NCT02209181|147534879|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.87|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|3.9|5.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.84|3.90|<0.001
73994491|NCT02209181|147534879|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.49||0.023|TWO_SIDED|95.0|0.16|2.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.09|0.16|0.023
73994492|NCT02209181|147534879|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.96|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.98|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.93|1.98|<0.001
73994493|NCT02209181|147534879|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.75|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-4.71|-2.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.78|-4.71|<0.001
73994494|NCT02209181|147534879|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.89|-0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.94|-2.89|<0.001
73994495|NCT02209181|147534880|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.71|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|3.64|5.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.78|3.64|<0.001
73994496|NCT02209181|147534880|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|0.54||0.012|TWO_SIDED|95.0|0.3|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.42|0.30|0.012
73994497|NCT02209181|147534880|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|2.66|4.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.81|2.66|<0.001
73994498|NCT02209181|147534880|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.35|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|-4.41|-2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.29|-4.41|<0.001
73994499|NCT02209181|147534880|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.54||0.074|TWO_SIDED|95.0|-2.05|0.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.09|-2.05|0.074
73994500|NCT02209181|147534881|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|2.63|4.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.97|2.63|<0.001
73994501|NCT02209181|147534881|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|0.59||0.026|TWO_SIDED|95.0|0.16|2.48||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.48|0.16|0.026
73994502|NCT02209181|147534881|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.82|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|2.64|4.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.99|2.64|<0.001
73994503|NCT02209181|147534881|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.64|-1.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.32|-3.64|<0.001
73994504|NCT02209181|147534881|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.6||0.978|TWO_SIDED|95.0|-1.16|1.19||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.19|-1.16|0.978
73994505|NCT02209181|147534882|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|2.18|4.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.62|2.18|<0.001
73994506|NCT02209181|147534882|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|0.61||0.081|TWO_SIDED|95.0|-0.13|2.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.28|-0.13|0.081
73994507|NCT02209181|147534882|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.91|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|2.69|5.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.14|2.69|<0.001
74035825|NCT00960934|147624169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.321|TWO_SIDED|95.0|-4.3|8.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||8.4|-4.3|0.321
73994508|NCT02209181|147534882|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.53|-1.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.11|-3.53|<0.001
74035826|NCT00960934|147624171|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.24||||0.959|TWO_SIDED|95.0|-1.03|1.51||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.51|-1.03|0.959
73994509|NCT02209181|147534882|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.62||0.407|TWO_SIDED|95.0|-0.71|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.74|-0.71|0.407
73994510|NCT02209181|147534883|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.56|4.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.10|1.56|<0.001
73994511|NCT02209181|147534883|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.64||0.17|TWO_SIDED|95.0|-0.38|2.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.14|-0.38|0.170
73994512|NCT02209181|147534883|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|2.33|4.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.87|2.33|<0.001
73994513|NCT02209181|147534883|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.64||0.002|TWO_SIDED|95.0|-3.21|-0.69||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.69|-3.21|0.002
73994514|NCT02209181|147534883|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.77|STANDARD_ERROR_OF_MEAN|0.65||0.235|TWO_SIDED|95.0|-0.5|2.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.04|-0.50|0.235
73994515|NCT02209181|147534884|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|0.65||0.001|TWO_SIDED|95.0|0.82|3.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.39|0.82|0.001
74035827|NCT00960934|147624171|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.02||||0.971|TWO_SIDED|95.0|-1.08|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.04|-1.08|0.971
73994516|NCT02209181|147534884|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.65||0.355|TWO_SIDED|95.0|-0.68|1.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.87|-0.68|0.355
73994517|NCT02209181|147534884|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.36|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|2.07|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.65|2.07|<0.001
73994518|NCT02209181|147534884|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.65||0.021|TWO_SIDED|95.0|-2.78|-0.23||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.23|-2.78|0.021
73994519|NCT02209181|147534884|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.65||0.056|TWO_SIDED|95.0|-0.03|2.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.55|-0.03|0.056
73994520|NCT02209181|147534885|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|0.66||0.067|TWO_SIDED|95.0|-0.09|2.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.50|-0.09|0.067
73994521|NCT02209181|147534885|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.65||0.547|TWO_SIDED|95.0|-0.89|1.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.68|-0.89|0.547
73994522|NCT02209181|147534885|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.16|STANDARD_ERROR_OF_MEAN|0.66|<|0.001|TWO_SIDED|95.0|1.86|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.46|1.86|<0.001
73994523|NCT02209181|147534885|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.65||0.214|TWO_SIDED|95.0|-2.1|0.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.47|-2.10|0.214
73994524|NCT02209181|147534885|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.96|STANDARD_ERROR_OF_MEAN|0.66||0.003|TWO_SIDED|95.0|0.66|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.26|0.66|0.003
73994525|NCT02209181|147534886|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.64||0.281|TWO_SIDED|95.0|-0.57|1.95||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.95|-0.57|0.281
73994526|NCT02209181|147534886|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.63||0.729|TWO_SIDED|95.0|-1.03|1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.47|-1.03|0.729
73994527|NCT02209181|147534886|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.21|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.95|4.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.47|1.95|<0.001
73994528|NCT02209181|147534886|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.63||0.459|TWO_SIDED|95.0|-1.72|0.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.78|-1.72|0.459
73994529|NCT02209181|147534886|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.52|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.26|3.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.78|1.26|<0.001
73994530|NCT02209181|147534887|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.65||0.674|TWO_SIDED|95.0|-1.0|1.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.55|-1.00|0.674
73994531|NCT02209181|147534887|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.64||0.417|TWO_SIDED|95.0|-0.74|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.79|-0.74|0.417
73994532|NCT02209181|147534887|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.05|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.77|4.33||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.33|1.77|<0.001
73994533|NCT02209181|147534887|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.64||0.698|TWO_SIDED|95.0|-1.02|1.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.52|-1.02|0.698
73876821|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|28.8||||0.086|TWO_SIDED|95.0|-2.5|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||60.0|-2.5|0.086
73994534|NCT02209181|147534887|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.49|4.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.05|1.49|<0.001
73994535|NCT02209181|147534888|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.64||0.541|TWO_SIDED|95.0|-0.87|1.66||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.66|-0.87|0.541
73994536|NCT02209181|147534888|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.64||0.409|TWO_SIDED|95.0|-0.73|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.79|-0.73|0.409
73994537|NCT02209181|147534888|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.12|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.85|4.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.39|1.85|<0.001
73994538|NCT02209181|147534888|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.64||0.834|TWO_SIDED|95.0|-1.12|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.39|-1.12|0.834
73994539|NCT02209181|147534888|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.73|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.45|4.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.00|1.45|<0.001
73994540|NCT02209181|147534889|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.64||0.573|TWO_SIDED|95.0|-0.9|1.63||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.63|-0.90|0.573
73994541|NCT02209181|147534889|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.64||0.448|TWO_SIDED|95.0|-0.77|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.74|-0.77|0.448
73994542|NCT02209181|147534889|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.98|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.71|4.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.25|1.71|<0.001
73876822|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|-10.0||||0.702|TWO_SIDED|95.0|-45.6|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||25.6|-45.6|0.702
73994543|NCT02209181|147534889|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.64||0.848|TWO_SIDED|95.0|-1.13|1.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.38|-1.13|0.848
73994544|NCT02209181|147534889|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.35|3.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.89|1.35|<0.001
73994545|NCT02209181|147534890|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.64||0.72|TWO_SIDED|95.0|-1.04|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-1.04|0.720
74035828|NCT00960934|147624171|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.24||||0.959|TWO_SIDED|95.0|-0.95|1.42||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.42|-0.95|0.959
74035829|NCT00960934|147624171|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.41||||0.915|TWO_SIDED|95.0|-1.78|0.97||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.97|-1.78|0.915
74035830|NCT00960934|147624171|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.28||||0.959|TWO_SIDED|95.0|-1.6|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.04|-1.60|0.959
74035831|NCT00960934|147624172|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.58||||0.849|TWO_SIDED|95.0|-1.22|2.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.37|-1.22|0.849
74035832|NCT00960934|147624172|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.16||||0.964|TWO_SIDED|95.0|-1.79|1.47||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.47|-1.79|0.964
73876823|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|-12.5||||0.557|TWO_SIDED|95.0|-24.0|-1.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||-1.0|-24.0|0.557
73994546|NCT02209181|147534890|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.64||0.763|TWO_SIDED|95.0|-1.07|1.45||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.45|-1.07|0.763
73994547|NCT02209181|147534890|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.82|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.55|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.09|1.55|<0.001
73994548|NCT02209181|147534890|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.64||0.952|TWO_SIDED|95.0|-1.3|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-1.30|0.952
73994549|NCT02209181|147534890|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.59|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.31|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.86|1.31|<0.001
73994550|NCT02209181|147534891|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.63||0.821|TWO_SIDED|95.0|-1.1|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.39|-1.10|0.821
73994551|NCT02209181|147534891|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.63||0.978|TWO_SIDED|95.0|-1.25|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-1.25|0.978
73994552|NCT02209181|147534891|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.88|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|1.63|4.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.13|1.63|<0.001
73876824|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.5|15.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.0|-16.5|1.000
73994553|NCT02209181|147534891|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.63||0.799|TWO_SIDED|95.0|-1.39|1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.07|-1.39|0.799
73994554|NCT02209181|147534891|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.73|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|1.49|3.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.98|1.49|<0.001
73994555|NCT02209181|147534892|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.7||0.726|TWO_SIDED|95.0|-1.62|1.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.13|-1.62|0.726
74035833|NCT00960934|147624172|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.964|TWO_SIDED|95.0|-1.27|1.59||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.59|-1.27|0.964
74035834|NCT00960934|147624172|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.48||||0.855|TWO_SIDED|95.0|-2.23|1.27||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.27|-2.23|0.855
74035835|NCT00960934|147624172|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.27||||0.287|TWO_SIDED|95.0|-0.58|3.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.12|-0.58|0.287
74035836|NCT00960934|147624173|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.6||||0.933|TWO_SIDED|95.0|-1.56|2.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.77|-1.56|0.933
73994556|NCT02209181|147534892|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.69||0.869|TWO_SIDED|95.0|-1.48|1.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.25|-1.48|0.869
73994557|NCT02209181|147534892|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.52|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.13|3.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.90|1.13|<0.001
73994558|NCT02209181|147534892|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.69||0.851|TWO_SIDED|95.0|-1.24|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-1.24|0.851
73994559|NCT02209181|147534892|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.76|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.38|4.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.15|1.38|<0.001
73994560|NCT02209181|147534893|SUPERIORITY_OR_OTHER|||||||0.042||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.042
73994561|NCT02209181|147534893|SUPERIORITY_OR_OTHER|||||||0.779||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.779
73994562|NCT02209181|147534893|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||<0.001
73994563|NCT02209181|147534893|SUPERIORITY_OR_OTHER|||||||0.196||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.196
73994564|NCT02209181|147534893|SUPERIORITY_OR_OTHER|||||||0.006||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.006
73994565|NCT02209181|147534894|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|1.1|1.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.9|1.1|<0.001
73994566|NCT02209181|147534894|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.077|TWO_SIDED|95.0|0.0|0.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.8|-0.0|0.077
73994567|NCT02209181|147534894|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|0.8|1.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.6|0.8|<0.001
73994568|NCT02209181|147534894|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.6|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.7|-1.6|<0.001
73994569|NCT02209181|147534894|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.148|TWO_SIDED|95.0|-0.7|0.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.1|-0.7|0.148
73994570|NCT04307940|147534990|SUPERIORITY||LS Mean Difference|14.81||||0.001|TWO_SIDED|95.0|6.1|23.51||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||23.51|6.10|0.001
73994571|NCT04307940|147534990|SUPERIORITY||LS Mean Difference|39.63|||<|0.001|TWO_SIDED|95.0|29.08|50.18||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||50.18|29.08|<0.001
73994572|NCT04307940|147534990|SUPERIORITY||LS Mean Difference|24.82|||<|0.001|TWO_SIDED|95.0|14.26|35.39||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||35.39|14.26|<0.001
73994573|NCT04896008|147535013|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.13|0.43||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||HR and associated 95% confidence interval were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||0.43|0.13|<0.0001
73994574|NCT04896008|147535014|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0313|TWO_SIDED|95.0|0.17|1.07||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||1.07|0.17|0.0313
73994575|NCT04896008|147535015|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.0039|TWO_SIDED|95.0|0.15|0.78||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||0.78|0.15|0.0039
73994576|NCT04896008|147535016|SUPERIORITY||Treatment Difference|-7.29||||0.135|TWO_SIDED|95.0|-17.65|2.41||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype)|||2.41|-17.65|0.135
73994577|NCT04896008|147535017|SUPERIORITY||Treatment Difference|-3.1|||<|0.001|TWO_SIDED|95.0|-4.25|-1.88||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by a randomization stratification factor (PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by a randomization stratification factor (PAH subtype).|||-1.88|-4.25|<0.001
73994578|NCT04896008|147535018|SUPERIORITY||Treatment Difference|33.05|||<|0.001|TWO_SIDED|95.0|18.41|46.98||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by a randomization stratification factor (PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by a randomization stratification factors (PAH subtype).|||46.98|18.41|<0.001
73994579|NCT04896008|147535019|SUPERIORITY||Treatment Difference|-2339.1|||<|0.001|TWO_SIDED|95.0|-3378.74|-1299.44||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-1299.44|-3378.74|<0.001
73994580|NCT04896008|147535020|SUPERIORITY||Treatment Difference|-21.2|||<|0.001|TWO_SIDED|95.0|-27.78|-14.59||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-14.59|-27.78|<0.001
73994581|NCT04896008|147535021|SUPERIORITY||Treatment Difference|-339.6|||<|0.001|TWO_SIDED|95.0|-511.09|-168.06||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-168.06|-511.09|<0.001
73994582|NCT04896008|147535022|SUPERIORITY||Treatment Difference|27.41|||<|0.001|TWO_SIDED|95.0|12.85|40.98||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||40.98|12.85|<0.001
73994583|NCT04896008|147535023|SUPERIORITY||Treatment Difference|63.0|||<|0.001|TWO_SIDED|95.0|23.22|102.73||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|||102.73|23.22|<0.001
73994584|NCT04896008|147535024|SUPERIORITY||Treatment Difference|0.5||||0.119|TWO_SIDED|95.0|-0.18|1.16||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype)|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|||1.16|-0.18|0.119
73994585|NCT01270828|147535026|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.||||<0.0001
73994586|NCT01270828|147535027|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.||||<0.0001
73994587|NCT01270828|147535028|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.||||<0.0001
73994588|NCT01270828|147535029|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.||||<0.0001
73994589|NCT01270828|147535030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.26|-0.62|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.62|-1.26|<0.0001
73994590|NCT01270828|147535030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.21|-0.61|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.61|-1.21|<0.0001
73994591|NCT01270828|147535031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.47|-0.75|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.75|-1.47|<0.0001
73994592|NCT01270828|147535031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.65|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.65|-1.34|<0.0001
73994593|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.0324|TWO_SIDED|95.0|-6.1|-0.3|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.3|-6.1|0.0324
73994594|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.0223|TWO_SIDED|95.0|-6.1|-0.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.5|-6.1|0.0223
73994595|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8||||0.0098|TWO_SIDED|95.0|-6.6|-0.9|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-0.9|-6.6|0.0098
73994596|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0||||0.0033|TWO_SIDED|95.0|-6.7|-1.4|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-1.4|-6.7|0.0033
74035837|NCT00960934|147624173|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.01||||0.999|TWO_SIDED|95.0|-1.69|1.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.68|-1.69|0.999
73876825|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|4.9||||0.707|TWO_SIDED|95.0|-14.4|24.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||24.2|-14.4|0.707
73876826|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|0.4||||1|TWO_SIDED|95.0|-27.9|28.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.8|-27.9|1.000
73994597|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3||||0.0002|TWO_SIDED|95.0|-11.1|-3.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-3.5|-11.1|0.0002
73994598|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-12.2|-5.2|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-5.2|-12.2|<0.0001
73994599|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.5264|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|||This ANCOVA model analysis is for Snoring-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.6|-2.8|0.5264
73994600|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.452|TWO_SIDED|95.0|-5.2|2.3|||ANCOVA|||This ANCOVA model analysis is for Snoring-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.3|-5.2|0.4520
73994601|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.3714|TWO_SIDED|95.0|-4.7|1.8|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||1.8|-4.7|0.3714
73994602|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.5639|TWO_SIDED|95.0|-4.2|2.3|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||2.3|-4.2|0.5639
73994603|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.3223|TWO_SIDED|95.0|-2.4|7.3|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.3|-2.4|0.3223
73994604|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.7||||0.2742|TWO_SIDED|95.0|-2.2|7.6|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.6|-2.2|0.2742
73994605|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9816|TWO_SIDED|95.0|-3.2|3.1|||ANCOVA|||This ANCOVA model analysis is for Somnolence-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.1|-3.2|0.9816
74035838|NCT00960934|147624173|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.05||||0.999|TWO_SIDED|95.0|-1.84|1.93||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.93|-1.84|0.999
73994606|NCT01270828|147535032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9282|TWO_SIDED|95.0|-2.9|3.2|||ANCOVA|||This ANCOVA model analysis is for Somnolence-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.2|-2.9|0.9282
73994607|NCT01270828|147535033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.1635|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||0.4|-0.1|0.1635
73994608|NCT01270828|147535033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.0363||95.0|0.0|0.5|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||0.5|0.0|0.0363
73994609|NCT01270828|147535034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432|||||||Chi-squared|||This analysis is for Week 6||||0.432
73994610|NCT01270828|147535034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.987|||||||Chi-squared|||This analysis is for Week 19||||0.987
73994611|NCT01270828|147535035|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85||||0.0007|TWO_SIDED|95.0|1.3|2.65|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio \> 1 is in favor of Pregabalin DB."|This analysis is for the original score. Proportional odds Logistic regression with a term for treatment in the model.||2.65|1.30|0.0007
73994612|NCT01270828|147535035|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.32||||0.0009|TWO_SIDED|95.0|1.41|3.81|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio \> 1 is in favor of Pregabalin DB."|This analysis is for the categorized score. Proportional odds Logistic regression with a term for treatment in the model.||3.81|1.41|0.0009
73994613|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.4||||0.0003|TWO_SIDED|95.0|3.4|11.5|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||11.5|3.4|0.0003
73994614|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.7|||<|0.0001|TWO_SIDED|95.0|4.0|11.3|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||11.3|4.0|<0.0001
73994615|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2||||0.0275|TWO_SIDED|95.0|0.4|6.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||6.0|0.4|0.0275
73994616|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4|||<|0.0001|TWO_SIDED|95.0|2.8|8.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||8.0|2.8|<0.0001
73994617|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.0735|TWO_SIDED|95.0|-0.3|6.4|||ANCOVA|||This ANCOVA model analysis is for Vitality-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.4|-0.3|0.0735
73994618|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.0684|TWO_SIDED|95.0|-0.2|6.2|||ANCOVA|||This ANCOVA model analysis is for Vitality-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.2|-0.2|0.0684
73994619|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1197|TWO_SIDED|95.0|-0.7|6.4|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.4|-0.7|0.1197
73994620|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1||||0.221|TWO_SIDED|95.0|-1.3|5.5|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.5|-1.3|0.2210
73994621|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3||||0.0847|TWO_SIDED|95.0|-0.5|7.1|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.1|-0.5|0.0847
73994622|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0||||0.0365|TWO_SIDED|95.0|0.3|7.8|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.8|0.3|0.0365
73994623|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.2749|TWO_SIDED|95.0|-1.2|4.3|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||4.3|-1.2|0.2749
73994624|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.0806|TWO_SIDED|95.0|-0.3|5.2|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.2|-0.3|0.0806
73994625|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0||||0.0082|TWO_SIDED|95.0|0.5|3.4|||ANCOVA|||This ANCOVA model analysis is for Physical component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.4|0.5|0.0082
73994626|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.0008|TWO_SIDED|95.0|1.0|3.7|||ANCOVA|||This ANCOVA model analysis is for Physical component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.7|1.0|0.0008
73994627|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.2097|TWO_SIDED|95.0|-0.8|2.5|||ANCOVA|||This ANCOVA model analysis is for Mental component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.5|-0.8|0.2097
73994628|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.1669|TWO_SIDED|95.0|-0.5|2.8|||ANCOVA|||This ANCOVA model analysis is for Mental component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.8|-0.5|0.1669
73994629|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1466|TWO_SIDED|95.0|-1.0|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.7|-1.0|0.1466
73994630|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4||||0.0439|TWO_SIDED|95.0|0.1|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.7|0.1|0.0439
73994631|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.9||||0.025|TWO_SIDED|95.0|0.6|9.3|||ANCOVA|||This ANCOVA model analysis is for Role Physical-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||9.3|0.6|0.0250
73994632|NCT01270828|147535036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4||||0.0107|TWO_SIDED|95.0|1.3|9.5|||ANCOVA|||This ANCOVA model analysis is for Role Physical-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||9.5|1.3|0.0107
73994633|NCT01270828|147535037|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.23|-0.64|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19.Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.64|-1.23|<0.0001
74090164|NCT01763918|147733542|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-56.0|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-61.41|-50.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.59|-61.41|<0.001
74090165|NCT01763918|147733542|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.01|STANDARD_ERROR_OF_MEAN|2.65|<|0.001|TWO_SIDED|95.0|-65.24|-54.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-54.77|-65.24|<0.001
73994634|NCT01270828|147535037|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.12|-0.58|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.58|-1.12|<0.0001
73994635|NCT01270828|147535038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0154|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.2|0.0154
73994636|NCT01270828|147535038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0027|TWO_SIDED|95.0|-1.3|-0.3|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.3|-1.3|0.0027
73994637|NCT01270828|147535038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0166|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.2|0.0166
73994638|NCT01270828|147535038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0217|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.1|0.0217
73994639|NCT01270828|147535039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.5|-3.0|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-3.0|-5.5|<0.0001
73994640|NCT01270828|147535039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.7|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-2.7|-5.0|<0.0001
73994641|NCT01270828|147535039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|||<|0.0001|TWO_SIDED|95.0|-6.5|-2.7|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-2.7|-6.5|<0.0001
73994642|NCT01270828|147535039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|||<|0.0001|TWO_SIDED|95.0|-6.0|-2.4|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-2.4|-6.0|<0.0001
73994643|NCT01270828|147535040|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.77||||0.0161|TWO_SIDED|95.0|1.34|17.0|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Benefit from treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||17.00|1.34|0.0161
73994644|NCT01270828|147535040|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.48||||0.0378|TWO_SIDED|95.0|1.05|5.85|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Satisfaction with treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||5.85|1.05|0.0378
73994645|NCT01270828|147535040|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.0901|TWO_SIDED|95.0|0.93|2.81|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Willingness to continue treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||2.81|0.93|0.0901
74035839|NCT00960934|147624173|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.45||||0.959|TWO_SIDED|95.0|-1.67|2.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.57|-1.67|0.959
74035840|NCT00960934|147624173|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.08||||0.999|TWO_SIDED|95.0|-2.1|1.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.94|-2.10|0.999
74035841|NCT00960934|147624174|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.17||||0.976|TWO_SIDED|95.0|-1.12|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.77|-1.12|0.976
74035842|NCT00960934|147624174|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.06||||0.982|TWO_SIDED|95.0|-0.93|0.8||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.80|-0.93|0.982
74035843|NCT00960934|147624174|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.53||||0.489|TWO_SIDED|95.0|-0.43|1.49||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.49|-0.43|0.489
74035844|NCT00960934|147624174|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.02||||0.982|TWO_SIDED|95.0|-0.75|0.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.78|-0.75|0.982
74035845|NCT00960934|147624174|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.976|TWO_SIDED|95.0|-0.76|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.08|-0.76|0.976
74090166|NCT01763918|147733543|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.79|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-60.47|-49.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-49.12|-60.47|<0.001
74035846|NCT00960934|147624175|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.35||||0.961|TWO_SIDED|95.0|-2.0|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.31|-2.00|0.961
74035847|NCT00960934|147624175|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.28||||0.961|TWO_SIDED|95.0|-1.9|1.34||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.34|-1.90|0.961
73994646|NCT00709228|147535055|SUPERIORITY_OR_OTHER||simple proportion|0.097|||||TWO_SIDED|95.0|0.06|0.15||||||||0.15|0.06|
73994647|NCT00789360|147535070|OTHER||Maximum LS mean change difference|0.0917|||||TWO_SIDED|90.0|-0.028|0.212|||||Maximum difference occurred at 10 hours|The largest treatment difference (Loxapine - Placebo) in change in FEV1 from baseline by spirometry||0.212|-0.028|
74090167|NCT01763918|147733543|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.95|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-61.95|-47.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-47.96|-61.95|<0.001
73994648|NCT00789360|147535071|OTHER||Maximum LS mean change difference|-0.154|||||TWO_SIDED|90.0|-0.29|-0.019|||||Greatest difference occurred at 9 hours after Dose 1|||-0.019|-0.290|
73994649|NCT03322540|147535088|SUPERIORITY||Difference in Percentages|-6.5||||0.8|TWO_SIDED|95.0|-21.5|8.7|||Stratified Miettinen and Nurminen method|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Point estimate was assessed based on Miettinen \& Nurminen method stratified by predominant tumor histology (squamous vs non-squamous).|||8.7|-21.5|0.8000
73994650|NCT03926195|147535130|OTHER||Difference in Percentage|5.8|||||TWO_SIDED|95.0|-7.5|19.2|||||Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test.|||19.2|-7.5|
73994651|NCT03926195|147535132|OTHER||Median Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-6.4|3.5|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||3.5|-6.4|
74090168|NCT01763918|147733544|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.39|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-54.32|-44.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-44.46|-54.32|<0.001
73994652|NCT03926195|147535134|OTHER||Median Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-37.1|36.8|||||Difference in medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||36.8|-37.1|
73994653|NCT03926195|147535136|OTHER||Median Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-6.0|20.8|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||20.8|-6.0|
73994654|NCT03926195|147535138|OTHER||Median Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.6|0.1|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||0.1|-0.6|
73994655|NCT03926195|147535140|OTHER||Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||1|-3|
73994656|NCT03054337|147535142|SUPERIORITY||Least squares mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.301||0.0045|TWO_SIDED|95.0|0.29|1.51|||ANCOVA|The analysis of covariance (ANCOVA) model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||1.51|0.29|0.0045
73994657|NCT03054337|147535142|SUPERIORITY||Least squares mean difference|1.59|STANDARD_ERROR_OF_MEAN|0.306|<|0.0001|TWO_SIDED|95.0|0.98|2.21|||ANCOVA|The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.21|0.98|<0.0001
74035848|NCT00960934|147624175|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.66||||0.778|TWO_SIDED|95.0|-1.01|2.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.33|-1.01|0.778
73876827|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|16.7||||0.175|TWO_SIDED|95.0|-7.2|40.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||40.6|-7.2|0.175
73994658|NCT03054337|147535142|SUPERIORITY||Least squares mean difference|2.09|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|1.49|2.7|||ANCOVA|The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.70|1.49|<0.0001
73994659|NCT03054337|147535148|SUPERIORITY||Least squares mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.103||0.0018|TWO_SIDED|95.0|0.13|0.55|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.55|0.13|0.0018
73994660|NCT03054337|147535148|SUPERIORITY||Least squares mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.103|<|0.0001|TWO_SIDED|95.0|0.3|0.72|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.72|0.30|<0.0001
73994661|NCT03054337|147535148|SUPERIORITY||Least squares mean difference|0.66|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|0.45|0.86|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.86|0.45|<0.0001
73994662|NCT03054337|147535148|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.005||0.7804|TWO_SIDED|95.0|-0.01|0.01|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.01|-0.01|0.7804
73994663|NCT03054337|147535148|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.0986|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.00|0.0986
73994664|NCT03054337|147535148|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.1661|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.00|0.1661
73994665|NCT03054337|147535150|SUPERIORITY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|0.942||0.001|TWO_SIDED|95.0|1.4|5.2|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||5.20|1.40|0.0010
73994666|NCT03054337|147535150|SUPERIORITY||Least squares mean difference|5.3|STANDARD_ERROR_OF_MEAN|0.953|<|0.0001|TWO_SIDED|95.0|3.38|7.22|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||7.22|3.38|<0.0001
73994667|NCT03054337|147535150|SUPERIORITY||Least squares mean difference|7.24|STANDARD_ERROR_OF_MEAN|0.93|<|0.0001|TWO_SIDED|95.0|5.37|9.11|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||9.11|5.37|<0.0001
73994668|NCT03054337|147535150|SUPERIORITY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.152||0.5889|TWO_SIDED|95.0|-0.39|0.22|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.22|-0.39|0.5889
73994669|NCT03054337|147535150|SUPERIORITY||Least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.151||0.8074|TWO_SIDED|95.0|-0.27|0.34|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.34|-0.27|0.8074
73994670|NCT03054337|147535150|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.148||0.6952|TWO_SIDED|95.0|-0.36|0.24|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.24|-0.36|0.6952
73994671|NCT03054337|147535152|SUPERIORITY|||||||0.3702|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.3702
73994672|NCT03054337|147535152|SUPERIORITY|||||||0.5524|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.5524
73994673|NCT03054337|147535152|SUPERIORITY|||||||0.1589|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.1589
73994674|NCT03054337|147535152|SUPERIORITY|||||||0.0092|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0092
73994675|NCT03054337|147535152|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||<0.0001
73994676|NCT03054337|147535152|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||<0.0001
73994677|NCT03054337|147535154|SUPERIORITY|||||||0.9092|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.9092
73994678|NCT03054337|147535154|SUPERIORITY|||||||0.1484|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.1484
73994679|NCT03054337|147535154|SUPERIORITY|||||||0.1313|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.1313
73994680|NCT03054337|147535156|SUPERIORITY|||||||0.108|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.1080
73994681|NCT03054337|147535156|SUPERIORITY|||||||0.0002|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0002
73994682|NCT03054337|147535156|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||<0.0001
73994683|NCT03054337|147535156|SUPERIORITY|||||||0.0672|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0672
73994684|NCT03054337|147535156|SUPERIORITY|||||||0.0004|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0004
73994685|NCT03054337|147535156|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||<0.0001
73994686|NCT03054337|147535163|SUPERIORITY|||||||0.0895|||||||Fisher Exact|||||||0.0895
73994687|NCT03054337|147535163|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73994688|NCT03054337|147535163|SUPERIORITY|||||||0.3845|||||||Fisher Exact|||||||0.3845
73994689|NCT01762904|147535168|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
73994690|NCT01762904|147535169|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
73994691|NCT01762904|147535170|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
73994692|NCT03738475|147535172|SUPERIORITY|||||||0.0056||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.0056
73994693|NCT03738475|147535176|SUPERIORITY|||||||0.0799||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.0799
73994694|NCT03738475|147535178|SUPERIORITY|||||||0.289||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.2890
73994695|NCT00755417|147535286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.38||0.0117|TWO_SIDED|97.5|-1.81|-0.11||Based on F test of type III analysis for pairwise comparison at 0.025 level.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4||-0.11|-1.81|0.0117
73994696|NCT00755417|147535286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|97.5|-2.35|-0.66||Based on F test of type III analysis|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4.||-0.66|-2.35|<0.0001
73994697|NCT00755417|147535287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.42||0.183|TWO_SIDED|97.5|-1.49|0.38||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12||0.38|-1.49|0.1830
73994698|NCT00755417|147535287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.41||0.1975|TWO_SIDED|97.5|-1.46|0.4||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12.||0.40|-1.46|0.1975
73994699|NCT00755417|147535288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.0016|TWO_SIDED|97.5|-0.44|-0.08||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.||-0.08|-0.44|0.0016
73994700|NCT00755417|147535288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|97.5|-0.51|-0.14||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.||-0.14|-0.51|<0.0001
73994701|NCT00755417|147535289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0433|TWO_SIDED|97.5|-0.43|0.02||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.||0.02|-0.43|0.0433
73994702|NCT00755417|147535289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0468|TWO_SIDED|97.5|-0.42|0.03||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.||0.03|-0.42|0.0468
73994703|NCT02362503|147535291|SUPERIORITY||Mean Difference (Net)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.81|-0.441||Hypothesis test:µfostemsavir=µPlacebo where µ is a common intercept.|ANCOVA||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||-0.441|-0.810|<0.0001
73994704|NCT02362503|147535292|OTHER||Mean Difference (Net)|45.69|||||TWO_SIDED|95.0|32.95|55.45|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \>0.5 log10 c/mL.|||55.45|32.95|
73994705|NCT02362503|147535292|OTHER||Mean Difference (Net)|35.67|||||TWO_SIDED|95.0|24.16|44.25|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \>1.0 log10 c/mL.|||44.25|24.16|
73994706|NCT02362503|147535298|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-16.8|16.0|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||16.0|-16.8|
73994707|NCT02362503|147535299|OTHER||Mean Difference (Net)|0.617|||||TWO_SIDED|95.0|0.082|1.151|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||1.151|0.082|
73994708|NCT01993849|147535316|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.69|TWO_SIDED|95.0|-3.81|2.59||The p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||||2.59|-3.81|0.69
73994709|NCT03443414|147535335|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.139|||<|0.001|TWO_SIDED|95.0|0.069|0.21|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).||0.210|0.069|<0.001
73994710|NCT03443414|147535335|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.2|||<|0.001|TWO_SIDED|95.0|0.131|0.27|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).||0.270|0.131|<0.001
74035849|NCT00960934|147624175|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.11||||0.961|TWO_SIDED|95.0|-1.45|1.24||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.24|-1.45|0.961
74035850|NCT00960934|147624175|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.25||||0.961|TWO_SIDED|95.0|-1.77|1.26||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.26|-1.77|0.961
74035851|NCT00960934|147624176|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.43||||0.901|TWO_SIDED|95.0|-2.03|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.17|-2.03|0.901
74035852|NCT00960934|147624176|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.51||||0.901|TWO_SIDED|95.0|-2.18|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.17|-2.18|0.901
73876828|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|8.7||||0.517|TWO_SIDED|95.0|-18.0|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.4|-18.0|0.517
73994711|NCT03443414|147535335|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.153|||<|0.001|TWO_SIDED|95.0|0.083|0.222|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).||0.222|0.083|<0.001
74035853|NCT00960934|147624176|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.52||||0.901|TWO_SIDED|95.0|-2.17|1.13||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.13|-2.17|0.901
73994712|NCT03443414|147535335|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.146|||<|0.001|TWO_SIDED|95.0|0.075|0.216|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).||0.216|0.075|<0.001
73994713|NCT03443414|147535336|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.002|||=|0.953|TWO_SIDED|95.0|-0.061|0.065|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).||0.065|-0.061|=0.953
73994714|NCT03443414|147535336|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.068|||=|0.032|TWO_SIDED|95.0|0.006|0.13|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).||0.130|0.006|=0.032
73994715|NCT03443414|147535336|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.009|||=|0.773|TWO_SIDED|95.0|-0.053|0.072|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).||0.072|-0.053|=0.773
73994716|NCT03443414|147535336|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.035|||=|0.272|TWO_SIDED|95.0|-0.028|0.099|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).||0.099|-0.028|=0.272
73994717|NCT03443414|147535337|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.087|||<|0.001|TWO_SIDED|95.0|0.045|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Day 1.||0.129|0.045|<0.001
73994718|NCT03443414|147535337|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.095|||<|0.001|TWO_SIDED|95.0|0.053|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Day 1.||0.137|0.053|<0.001
73994719|NCT03443414|147535337|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.07|||=|0.001|TWO_SIDED|95.0|0.028|0.112|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Day 1.||0.112|0.028|=0.001
73994720|NCT03443414|147535337|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.08|||<|0.001|TWO_SIDED|95.0|0.038|0.122|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Day 1.||0.122|0.038|<0.001
73994721|NCT03443414|147535337|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.065|||=|0.048|TWO_SIDED|95.0|0.001|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Week 4.||0.129|0.001|=0.048
73994722|NCT03443414|147535337|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.119|||<|0.001|TWO_SIDED|95.0|0.055|0.183|||LS mean difference|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Week 4.||0.183|0.055|<0.001
73994723|NCT03443414|147535337|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.085|||=|0.008|TWO_SIDED|95.0|0.022|0.149|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Week 4.||0.149|0.022|=0.008
73994724|NCT03443414|147535337|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.072|||=|0.028|TWO_SIDED|95.0|0.008|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Week 4.||0.137|0.008|=0.028
73994725|NCT03325777|147535353|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.29|=|0.014|TWO_SIDED|95.0|0.14|1.27||a priori threshold is p\<.05|Mixed Models Analysis|Generalized Linear Mixed Models||||1.27|.14|=.014
73994726|NCT03325777|147535354|SUPERIORITY||Mean Difference (Final Values)|172.0|STANDARD_ERROR_OF_MEAN|33.2|<|0.001|TWO_SIDED|95.0|106.0|238.0||a priori threshold for significance was p\<.05|Mixed Models Analysis|||||238|106|<.001
73994727|NCT03004404|147535359|OTHER||Slope|0.748|STANDARD_ERROR_OF_MEAN|0.0743|||TWO_SIDED|95.0|0.5959|0.9001|||||Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|In the SRD part of the trial, dose proportionality for AUC0-inf was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).||0.9001|0.5959|
73994728|NCT03004404|147535359|OTHER||Ratio T/R|118.71|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|94.57|149.03|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.|Relative bioavailability of AUC0-inf for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an Analysis of Variance (ANOVA) model on the logarithmic scale.||149.03|94.57|
73994729|NCT03004404|147535359|OTHER||Geometric mean ratio T1/R (%)|124.79|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|90.0|116.858|133.255|||||Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.|Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Auc0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.|133.255|116.858|
73994730|NCT03004404|147535359|OTHER||Geometric mean ratio T2/R (%)|125.17|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|112.89|138.8|||||Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.|Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for tablet fed (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of AUC0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.|138.80|112.89|
73994731|NCT03004404|147535360|OTHER||Slope|0.7065|STANDARD_ERROR_OF_MEAN|0.0587|||TWO_SIDED|95.0|0.5863|0.8267|||||Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1|In the SRD part of the trial, dose proportionality for Cmax was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).||0.8267|0.5863|
73994732|NCT03004404|147535360|OTHER||Ratio T/R|151.22|STANDARD_ERROR_OF_MEAN|1.107|||TWO_SIDED|90.0|122.781|186.248|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.|Relative bioavailability of the Cmax for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an ANOVA model on the logarithmic scale.||186.248|122.781|
73994733|NCT03004404|147535360|OTHER||Geometric mean ratio T1/R (%)|293.21|STANDARD_ERROR_OF_MEAN|1.069|||TWO_SIDED|90.0|259.044|331.891|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.|Estimation of relative bioavailability of Cmax based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.|331.891|259.044|
73994734|NCT03004404|147535360|OTHER||Geometric mean ratio T2/R (%)|180.53|STANDARD_ERROR_OF_MEAN|1.059|||TWO_SIDED|90.0|162.369|200.732|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.|Estimation of relative bioavailability of Cmax was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for tablet fasted (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.|200.732|162.369|
73994735|NCT04692467|147535368|SUPERIORITY||Mean Difference (Final Values)|-5.88|||<|0.0001|TWO_SIDED|95.0|-8.77|-3.01|||Mixed Models Analysis||The mean difference reflects the difference in mean change (i.e., mean change = 12 months minus baseline for each arm) between the intervention arm and SOC arm (direction = intervention arm minus SOC arm).|||-3.01|-8.77|<0.0001
73994736|NCT00422734|147535389|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
73994737|NCT00422734|147535390|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Subject. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
73994738|NCT00422734|147535390|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Partner. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
73994739|NCT00422734|147535391|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994740|NCT00422734|147535392|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994741|NCT00422734|147535393|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for subject scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
73994742|NCT00422734|147535393|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for partner scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
73994743|NCT00422734|147535394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for SEP Question 2. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
73994744|NCT00422734|147535394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for SEP Question 3. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
73994745|NCT00422734|147535395|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for SEP Question 4|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994746|NCT00422734|147535395|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for SEP Question 5|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994747|NCT00422734|147535396|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994748|NCT00422734|147535397|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994749|NCT00422734|147535398|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
73994750|NCT00422734|147535398|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
73994751|NCT00422734|147535399|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
73994752|NCT00422734|147535399|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
73994753|NCT00422734|147535400|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEP Question 1|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
74035854|NCT00960934|147624176|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.03||||0.997|TWO_SIDED|95.0|-1.29|1.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.35|-1.29|0.997
74035855|NCT00960934|147624176|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.04||||0.997|TWO_SIDED|95.0|-1.51|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.43|-1.51|0.997
73994754|NCT00422734|147535400|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEP Question 2|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994755|NCT00422734|147535401|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Total Score|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994756|NCT00422734|147535401|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Sexual Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994757|NCT00422734|147535401|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Confidence|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994758|NCT00422734|147535402|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Self-Esteem|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994759|NCT00422734|147535402|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Overall Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
73994760|NCT02567708|147535405|OTHER||Posterior median difference.|0.007|STANDARD_DEVIATION|0.0468||0.57|TWO_SIDED|95.0|-0.083|0.102||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.102|-0.083|0.57
73994761|NCT02567708|147535406|OTHER||Posterior median difference.|0.013|STANDARD_DEVIATION|0.0501||0.61|TWO_SIDED|95.0|-0.084|0.113||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.113|-0.084|0.61
73994762|NCT02567708|147535407|OTHER|The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Posterior median difference|0.05|STANDARD_DEVIATION|0.0818||0.731|TWO_SIDED|95.0|-0.111|0.21|||Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.210|-0.111|0.731
74035856|NCT00960934|147624177|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.37||||0.979|TWO_SIDED|95.0|-2.73|1.99||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.99|-2.73|0.979
74035857|NCT00960934|147624177|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.92||||0.363|TWO_SIDED|95.0|-1.1|4.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||4.95|-1.10|0.363
74035858|NCT00960934|147624177|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.4||||0.979|TWO_SIDED|95.0|-2.18|2.98||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.98|-2.18|0.979
73994763|NCT02567708|147535408|OTHER||Posterior median difference|-0.009|STANDARD_DEVIATION|0.0712||0.44|TWO_SIDED|95.0|-0.151|0.131||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.131|-0.151|0.44
73994764|NCT02567708|147535408|OTHER||Posterior median difference|0.024|STANDARD_DEVIATION|0.057||0.66|TWO_SIDED|95.0|-0.087|0.137||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.137|-0.087|0.66
73994765|NCT02567708|147535409|OTHER||Posterior median difference|-0.021|STANDARD_DEVIATION|0.0609||0.35|TWO_SIDED|95.0|-0.14|0.099||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.099|-0.140|0.35
73994766|NCT02567708|147535409|OTHER||Posterior median difference|0.04|STANDARD_DEVIATION|0.0578||0.76|TWO_SIDED|95.0|-0.071|0.156||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.156|-0.071|0.76
73994767|NCT02567708|147535409|OTHER||Posterior median difference|0.038|STANDARD_DEVIATION|0.0559||0.76|TWO_SIDED|95.0|-0.073|0.148||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.148|-0.073|0.76
73994768|NCT02567708|147535410|OTHER||Posterior median difference|0.083|STANDARD_DEVIATION|0.6175||0.56|TWO_SIDED|95.0|-1.102|1.346||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.346|-1.102|0.56
73994769|NCT02567708|147535410|OTHER||Posterior median difference|0.014|STANDARD_DEVIATION|0.6672||0.51|TWO_SIDED|95.0|-1.271|1.341||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.341|-1.271|0.51
74035859|NCT00960934|147624177|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.49||||0.979|TWO_SIDED|95.0|-3.27|2.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.30|-3.27|0.979
74035860|NCT00960934|147624177|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.51||||0.979|TWO_SIDED|95.0|-2.34|3.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.37|-2.34|0.979
73994770|NCT02567708|147535410|OTHER||Posterior median difference|-0.113|STANDARD_DEVIATION|0.5148||0.41|TWO_SIDED|95.0|-1.125|0.908||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo..|||0.908|-1.125|0.41
74035861|NCT00960934|147624178|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|19.77||||0.02|TWO_SIDED|95.0|2.26|37.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||37.46|2.26|0.020
74039717|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0001|TWO_SIDED|95.0|1.43|3.02|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.02|1.43|0.0001
74039718|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.57|3.28|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.28|1.57|<.0001
74039719|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.34||||0.118|TWO_SIDED|95.0|0.93|1.92|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.92|0.93|0.1180
74039720|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0062|TWO_SIDED|95.0|1.13|2.14|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.14|1.13|0.0062
73994771|NCT02567708|147535411|OTHER||Posterior median difference|0.5|STANDARD_DEVIATION|0.59||0.81|TWO_SIDED|95.0|-0.6|1.7||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.7|-0.6|0.81
73994772|NCT02567708|147535414|OTHER||Posterior median ratio|0.89|STANDARD_DEVIATION|0.063||0.97|TWO_SIDED|95.0|0.78|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.00|0.78|0.97
73994773|NCT02567708|147535414|OTHER||Posterior median ratio|0.95|STANDARD_DEVIATION|0.071||0.76|TWO_SIDED|95.0|0.83|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.09|0.83|0.76
73994774|NCT02567708|147535414|OTHER||Posterior median ratio|1.0|STANDARD_DEVIATION|0.085||0.51|TWO_SIDED|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than one.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.18|0.84|0.51
73994775|NCT05262751|147535428|OTHER||gMean Ratio|16.69|||||TWO_SIDED|90.0|7.28|38.24|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 34.1|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||38.24|7.28|
73994776|NCT05262751|147535428|OTHER||gMean Ratio|13.54|||||TWO_SIDED|90.0|8.1|22.64|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 34.1|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||22.64|8.10|
73994777|NCT05262751|147535428|OTHER||gMean Ratio|41.8|||||TWO_SIDED|90.0|34.24|51.04|||||gMean Ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 28.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||51.04|34.24|
73994778|NCT05262751|147535428|OTHER||gMean Ratio|42.91|||||TWO_SIDED|90.0|34.9|52.76|||||gMean Ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 28.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||52.76|34.90|
73994779|NCT05262751|147535429|OTHER||gMean Ratio|9.36|||||TWO_SIDED|90.0|5.91|14.8|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 44.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||14.80|5.91|
73994780|NCT05262751|147535429|OTHER||gMean Ratio|12.41|||||TWO_SIDED|90.0|7.93|19.43|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 44.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||19.43|7.93|
73994781|NCT05262751|147535429|OTHER||gMean Ratio|37.9|||||TWO_SIDED|90.0|29.25|49.11|||||gMean Ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 40.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||49.11|29.25|
73994782|NCT05262751|147535429|OTHER||gMean Ratio|35.89|||||TWO_SIDED|90.0|27.66|46.55|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 40.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||46.55|27.66|
73994783|NCT05262751|147535430|OTHER||gMean Ratio|12.09|||||TWO_SIDED|90.0|6.73|21.71|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 58.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||21.71|6.73|
73994784|NCT05262751|147535430|OTHER||gMean Ratio|23.94|||||TWO_SIDED|90.0|13.51|42.42|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 58.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||42.42|13.51|
73994785|NCT05262751|147535430|OTHER||gMean Ratio|68.55|||||TWO_SIDED|90.0|50.07|93.86|||||gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 50.0|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||93.86|50.07|
74035862|NCT00960934|147624178|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|10.08||||0.357|TWO_SIDED|95.0|-6.16|26.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||26.41|-6.16|0.357
73994786|NCT05262751|147535430|OTHER||gMean Ratio|66.85|||||TWO_SIDED|90.0|48.77|91.64|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 50.0|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||91.64|48.77|
73994787|NCT05262751|147535431|OTHER||gMean Ratio|11.96|||||TWO_SIDED|90.0|8.88|16.11|||||gMean ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 23.5|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||16.11|8.88|
73994788|NCT05262751|147535431|OTHER||gMean Ratio|13.98|||||TWO_SIDED|90.0|10.59|18.46|||||gMean ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 23.5|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||18.46|10.59|
73994789|NCT05262751|147535431|OTHER||gMean Ratio|32.13|||||TWO_SIDED|90.0|26.46|39.01|||||gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 29.3.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||39.01|26.46|
73994790|NCT05262751|147535431|OTHER||gMean Ratio|31.38|||||TWO_SIDED|90.0|25.71|38.3|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 29.3.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||38.30|25.71|
73994791|NCT01151215|147535434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.485|TWO_SIDED|95.0|0.77|1.75||Statistical significance threshold at this interim analysis was 5%|Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard Ratio is for AZD8931 40mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio \<1 favours AZD8931 40mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.60, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.||1.75|0.77|0.485
73994792|NCT01151215|147535434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.135|TWO_SIDED|95.0|0.91|2.06|||Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard ratio is for AZD8931 20mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio \< 1 favours AZD8931 20mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.6, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.||2.06|0.91|0.135
73994793|NCT01721954|147535436|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.43|TWO_SIDED|95.0|||||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is overall survival (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is OS time for SIRT/FOLFOX treatment lower to that of FOLFOX.||||0.43
73994794|NCT01721954|147535437|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED||||||Log Rank|||A sample size of at least 209 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 14.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 209. The Null hypothesis is no difference between the treatment arms with respect to PFS.||||<0.05
73994795|NCT03392168|147535439|SUPERIORITY||Least squares mean difference|-28.5||||0.0007|TWO_SIDED|95.0|-44.6|-12.4|||Mixed Models Analysis|||LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-12.4|-44.6|0.0007
73876829|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
73994796|NCT03392168|147535439|SUPERIORITY||Least squares mean difference|-27.8||||0.0011|TWO_SIDED|95.0|-44.2|-11.5|||Mixed Models Analysis|||LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-11.5|-44.2|0.0011
73994797|NCT03392168|147535440|SUPERIORITY||Least squares mean difference|-3.2||||0.5493|TWO_SIDED|95.0|-13.7|7.3|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||7.3|-13.7|0.5493
73994798|NCT03392168|147535440|SUPERIORITY||Least squares mean difference|-4.9||||0.365|TWO_SIDED|95.0|-15.7|5.9|||Mixed Models Analysis|||At week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.9|-15.7|0.3650
74035863|NCT00960934|147624178|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-2.83||||0.642|TWO_SIDED|95.0|-14.81|9.14||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||9.14|-14.81|0.642
74039721|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0009|TWO_SIDED|95.0|1.24|2.32|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|1.24|0.0009
73994799|NCT03392168|147535440|SUPERIORITY||Least squares mean difference|-18.3||||0.0064|TWO_SIDED|95.0|-31.3|-5.3|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-5.3|-31.3|0.0064
73994800|NCT03392168|147535440|SUPERIORITY||Least squares mean difference|-19.8||||0.0039|TWO_SIDED|95.0|-33.0|-6.5|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-6.5|-33.0|0.0039
73994801|NCT03392168|147535440|SUPERIORITY||Least squares mean difference|-28.9||||0.0001|TWO_SIDED|95.0|-42.9|-14.8|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-14.8|-42.9|0.0001
73994802|NCT03392168|147535440|SUPERIORITY||Least squares mean difference|-23.0||||0.0019|TWO_SIDED|95.0|-37.3|-8.7|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-8.7|-37.3|0.0019
73994803|NCT03392168|147535441|SUPERIORITY||Least squares mean difference|-4.3||||0.3626|TWO_SIDED|95.0|-13.6|5.0|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.0|-13.6|0.3626
73994804|NCT03392168|147535441|SUPERIORITY||Least squares mean difference|-8.1||||0.1011|TWO_SIDED|95.0|-17.8|1.6|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||1.6|-17.8|0.1011
73994805|NCT03392168|147535441|SUPERIORITY||Least squares mean difference|-15.5||||0.0017|TWO_SIDED|95.0|-25.1|-6.0|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-6.0|-25.1|0.0017
73994806|NCT03392168|147535441|SUPERIORITY||Least squares mean difference|-19.3||||0.0002|TWO_SIDED|95.0|-29.1|-9.4|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-9.4|-29.1|0.0002
73994807|NCT03392168|147535441|SUPERIORITY||Least squares mean difference|-21.3||||0.0003|TWO_SIDED|95.0|-32.4|-10.2|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.2|-32.4|0.0003
73994808|NCT03392168|147535441|SUPERIORITY||Least squares mean difference|-21.8||||0.0003|TWO_SIDED|95.0|-33.2|-10.4|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.4|-33.2|0.0003
73994809|NCT03392168|147535441|SUPERIORITY||Least squares mean difference|-18.7||||0.001|TWO_SIDED|95.0|-29.5|-7.8|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-7.8|-29.5|0.0010
73994810|NCT03392168|147535441|SUPERIORITY||Least squares mean difference|-21.8||||0.0002|TWO_SIDED|95.0|-32.9|-10.6|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.6|-32.9|0.0002
73994811|NCT03392168|147535442|SUPERIORITY||Least squares mean difference|2.67||||0.3209|TWO_SIDED|95.0|-2.65|7.99|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||7.99|-2.65|0.3209
73994812|NCT03392168|147535442|SUPERIORITY||Least squares mean difference|3.6||||0.1947|TWO_SIDED|95.0|-1.88|9.08|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||9.08|-1.88|0.1947
73994813|NCT03392168|147535442|SUPERIORITY||Least squares mean difference|-4.58||||0.3561|TWO_SIDED|95.0|-14.4|5.24|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.24|-14.40|0.3561
74035864|NCT00960934|147624178|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.44||||0.434|TWO_SIDED|95.0|-7.09|24.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||24.04|-7.09|0.434
73994814|NCT03392168|147535442|SUPERIORITY||Least squares mean difference|-5.82||||0.249|TWO_SIDED|95.0|-15.79|4.16|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||4.16|-15.79|0.2490
73994815|NCT03392168|147535442|SUPERIORITY||Least squares mean difference|-12.68||||0.0276|TWO_SIDED|95.0|-23.992|-1.44|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-1.44|-23.992|0.0276
73994816|NCT03392168|147535442|SUPERIORITY||Least squares mean difference|-7.04||||0.2223|TWO_SIDED|95.0|-18.44|4.36|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||4.36|-18.44|0.2223
73994817|NCT03392168|147535442|SUPERIORITY||Least squares mean difference|-20.27||||0.0108|TWO_SIDED|95.0|-35.72|-4.82|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-4.82|-35.72|0.0108
73994818|NCT03392168|147535442|SUPERIORITY||Least squares mean difference|-16.67||||0.0372|TWO_SIDED|95.0|-32.34|-1.01|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-1.01|-32.34|0.0372
73876830|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
73994819|NCT02627118|147535447|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
73994820|NCT01154140|147535448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.454|||<|0.0001|TWO_SIDED|95.0|0.346|0.596||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group performance status (ECOG PS),race,brain metastases. 1-sided log-rank test at 0.0247 level of significance was used to compare PFS between the 2 arms.|Log Rank|||||0.596|0.346|<0.0001
73994821|NCT01154140|147535449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0489|TWO_SIDED|95.0|0.548|1.053||P-value was obtained from 1-sided log rank test, stratified by ECOG PS, race group and brain metastases.|Log Rank||HR was calculated based on the Cox Proportional hazards model stratified by ECOG PS, race group, and brain metastases. Assuming proportional hazards, a hazard ratio (less than)\<1 indicates a reduction in hazard rate in favor of crizotinib.|||1.053|0.548|0.0489
73994822|NCT01154140|147535451|SUPERIORITY_OR_OTHER||Difference in Percentage|29.4|||<|0.0001|TWO_SIDED|95.0|19.5|39.3||P-value was obtained from a Pearson chi-square test.|Pearson chi-square test||95% CI was calculated based on normal distribution.|If the PFS endpoint was significant, ORR was to be considered significant if the 2-sided p-value from Pearson chi-square test was (less than or equal to)\<= 0.0494.||39.3|19.5|<0.0001
73994823|NCT01154140|147535454|SUPERIORITY_OR_OTHER||Difference in Percentage|10.067||||0.0381|TWO_SIDED|95.0|0.8|19.4|||Pearson chi-square test|||The confidence interval for the difference in percentage was based on normal distribution.||19.4|0.8|0.0381
73994824|NCT01154140|147535455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.441|||<|0.0001|TWO_SIDED|95.0|0.335|0.582||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR \<1 indicated a reduction in hazard rate in favor of Crizotinib.||0.582|0.335|<0.0001
73994825|NCT01154140|147535456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.595||||0.0347|TWO_SIDED|95.0|0.338|1.048||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.||1.048|0.338|0.0347
73994826|NCT01154140|147535457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.286|0.524||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.||0.524|0.286|<0.0001
73994827|NCT01154140|147535464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.591||||0.0002|TWO_SIDED|95.0|0.452|0.773||Two-sided p-value from the unstratified log rank test was used.|Log Rank|||HR was calculated based on the Cox Proportional hazards model. Assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of crizotinib.||0.773|0.452|0.0002
73994828|NCT01154140|147535465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.8303|||<|0.0001|TWO_SIDED|95.0|10.74|16.92|||Mixed Models Analysis|||QLQ-C30 Global QoL: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||16.92|10.74|<0.0001
73994829|NCT01154140|147535465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3532||||0.017|TWO_SIDED|95.0|0.6|6.11|||Mixed Models Analysis|||QLQ-C30 cognitive functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||6.11|0.60|0.0170
73994830|NCT01154140|147535465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5165|||<|0.0001|TWO_SIDED|95.0|4.57|10.46|||Mixed Models Analysis|||QLQ-C30 emotional functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||10.46|4.57|<0.0001
73994831|NCT01154140|147535465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.4035|||<|0.0001|TWO_SIDED|95.0|7.48|13.32|||Mixed Models Analysis|||QLQ-C30 physical functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||13.32|7.48|<0.0001
73994832|NCT01154140|147535465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.5513|||<|0.0001|TWO_SIDED|95.0|11.29|19.81|||Mixed Models Analysis|||QLQ-C30 role functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||19.81|11.29|<0.0001
73994833|NCT01154140|147535465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7641|||<|0.0001|TWO_SIDED|95.0|4.69|12.84|||Mixed Models Analysis|||QLQ-C30 social functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||12.84|4.69|<0.0001
73994834|NCT01154140|147535466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.4976|||<|0.0001|TWO_SIDED|95.0|-18.03|-8.97|||Mixed Models Analysis|||QLQ-C30 appetite loss: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-8.97|-18.03|<0.0001
73994835|NCT01154140|147535466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4336||||0.057|TWO_SIDED|95.0|-9.0|0.13|||Mixed Models Analysis|||QLQ-C30 constipation: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||0.13|-9.00|0.0570
73994836|NCT01154140|147535466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.4906|||<|0.0001|TWO_SIDED|95.0|8.98|16.0|||Mixed Models Analysis|||QLQ-C30 diarrhea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||16.00|8.98|<0.0001
73994837|NCT01154140|147535466|SUPERIORITY_OR_OTHER||Median Difference (Net)|-13.4622|||<|0.0001|TWO_SIDED|95.0|-17.2|-9.73|||Mixed Models Analysis|||QLQ-C30 dysponea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-9.73|-17.20|<0.0001
73994838|NCT01154140|147535466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.9987|||<|0.0001|TWO_SIDED|95.0|-18.52|-11.48|||Mixed Models Analysis|||QLQ-C30 fatigue: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-11.48|-18.52|<0.0001
73994839|NCT01154140|147535466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8186||||0.6681|TWO_SIDED|95.0|-4.56|2.92|||Mixed Models Analysis|||QLQ-C30 financial difficulties: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||2.92|-4.56|0.6681
73994840|NCT01154140|147535466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.043|||<|0.0001|TWO_SIDED|95.0|-14.22|-5.87|||Mixed Models Analysis|||QLQ-C30 insomnia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-5.87|-14.22|<0.0001
73994841|NCT01154140|147535466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4446||||0.0468|TWO_SIDED|95.0|-6.84|-0.05|||Mixed Models Analysis|||QLQ-C30 nausea and vomiting: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-0.05|-6.84|0.0468
73994842|NCT01154140|147535466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.9277|||<|0.0001|TWO_SIDED|95.0|-13.23|-6.62|||Mixed Models Analysis|||QLQ-C30 pain: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-6.62|-13.23|<0.0001
73994843|NCT01154140|147535467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8149||||0.0108|TWO_SIDED|95.0|-8.52|-1.11|||Mixed Models Analysis|||QLQ-LC13 alopecia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-1.11|-8.52|0.0108
73994844|NCT01154140|147535467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.3926|||<|0.0001|TWO_SIDED|95.0|-12.06|-4.72|||Mixed Models Analysis|||QLQ-LC13 coughing: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-4.72|-12.06|<0.0001
73994845|NCT01154140|147535467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6651||||0.5938|TWO_SIDED|95.0|-1.78|3.11|||Mixed Models Analysis|||QLQ-LC13 dysphagia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||3.11|-1.78|0.5938
73994846|NCT01154140|147535467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.008|||<|0.0001|TWO_SIDED|95.0|-11.96|-6.06|||Mixed Models Analysis|||QLQ-LC13 dyspnoea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-6.06|-11.96|<0.0001
73994847|NCT01154140|147535467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8828||||0.0656|TWO_SIDED|95.0|-1.82|0.06|||Mixed Models Analysis|||QLQ-LC13 haemoptysis: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||0.06|-1.82|0.0656
74035865|NCT00960934|147624178|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|5.72||||0.579||95.0|-8.62|20.1||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||20.10|-8.62|0.579
74035866|NCT00960934|147624179|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|34.26|||<|0.001|TWO_SIDED|95.0|15.27|53.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||53.56|15.27|<0.001
74035867|NCT00960934|147624179|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|20.57||||0.014|TWO_SIDED|95.0|3.28|38.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||38.02|3.28|0.014
74090169|NCT01763918|147733544|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.98|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-59.58|-50.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.38|-59.58|<0.001
74090170|NCT01763918|147733545|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.09|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-54.55|-43.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-43.63|-54.55|<0.001
73994848|NCT01154140|147535467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.0475||||0.0002|TWO_SIDED|95.0|-9.22|-2.88|||Mixed Models Analysis|||QLQ-LC13 pain in arm or shoulder: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-2.88|-9.22|0.0002
74035868|NCT00960934|147624179|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|9.97||||0.307|TWO_SIDED|95.0|-5.69|25.7||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||25.70|-5.69|0.307
74035869|NCT00960934|147624179|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|9.02||||0.307|TWO_SIDED|95.0|-5.85|23.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||23.95|-5.85|0.307
74035870|NCT00960934|147624179|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.5||||0.937|TWO_SIDED|95.0|-12.92|11.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||11.92|-12.92|0.937
74035871|NCT00960934|147624180|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|19.19|||<|0.001|TWO_SIDED|95.0|7.42|31.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||31.02|7.42|<0.001
74090171|NCT01763918|147733545|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.41|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|-55.73|-43.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-43.10|-55.73|<0.001
74090172|NCT01763918|147733546|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.59|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-51.43|-41.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-41.76|-51.43|<0.001
74090173|NCT01763918|147733546|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.16|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-54.21|-44.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-44.11|-54.21|<0.001
74090174|NCT01763918|147733547|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.08|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|-51.27|-40.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-40.88|-51.27|<0.001
73994849|NCT01154140|147535467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0959|||<|0.0001|TWO_SIDED|95.0|-11.35|-4.84|||Mixed Models Analysis|||QLQ-LC13 pain in chest: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-4.84|-11.35|<0.0001
73994850|NCT01154140|147535467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7717||||0.0001|TWO_SIDED|95.0|-10.24|-3.31|||Mixed Models Analysis|||QLQ-LC13 pain in other parts: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-3.31|-10.24|0.0001
73876831|NCT02365649|147294848|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
73876832|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-41.0|41.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||41.0|-41.0|1.000
73994851|NCT01154140|147535467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3521||||0.0427|TWO_SIDED|95.0|0.11|6.59|||Mixed Models Analysis|||QLQ-LC13 peripheral neuropathy: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||6.59|0.11|0.0427
73994852|NCT01154140|147535467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1521||||0.1382|TWO_SIDED|95.0|-5.0|0.69|||Mixed Models Analysis|||QLQ-LC13 sore mouth: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||0.69|-5.00|0.1382
73994853|NCT01154140|147535468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.9908||||0.0139|TWO_SIDED|95.0|0.81|7.17|||Mixed Models Analysis|||Analysis was based on a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EQ-5D VAS subscale baseline score (intercept and time from first dose were included as random effects).||7.17|0.81|0.0139
74039722|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0003|TWO_SIDED|95.0|1.56|4.61|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.61|1.56|0.0003
74039723|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|1.82|5.28|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||5.28|1.82|<.0001
74039724|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.33||||0.312|TWO_SIDED|95.0|0.76|2.32|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|0.76|0.3120
74039725|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0019|TWO_SIDED|95.0|1.3|3.14|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.14|1.30|0.0019
74039726|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0001|TWO_SIDED|95.0|1.52|3.59|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.59|1.52|0.0001
74039727|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0064|TWO_SIDED|95.0|1.12|1.95|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.95|1.12|0.0064
74039728|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0001|TWO_SIDED|95.0|1.32|2.31|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.31|1.32|0.0001
74039729|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2757|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.48|0.89|0.2757
74039730|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0575|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.65|0.99|0.0575
74039731|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0015|TWO_SIDED|95.0|1.17|1.96|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.96|1.17|0.0015
74039732|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0007|TWO_SIDED|95.0|1.23|2.16|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.16|1.23|0.0007
74039733|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0001|TWO_SIDED|95.0|1.31|2.31|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.31|1.31|0.0001
74039734|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0124|TWO_SIDED|95.0|1.07|1.79|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.79|1.07|0.0124
73994854|NCT02992691|147535481|OTHER||Mean Difference (Net)|-0.01||||0.6674|TWO_SIDED|95.0|-0.06|0.04||From ANCOVA analysis for change from pre-brushing with treatment and period as fixed effect, participant as random effect, participant-level baseline and period level minus participant-level baseline as covariates.|ANCOVA|||This comparison was tested under a null hypothesis of no difference against alternative hypothesis of a difference between treatments||0.04|-0.06|0.6674
73994855|NCT00392925|147535506|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANCOVA|||Based on an Analysis of Covariance model including factors for treatment group, sex, enrollment body mass index (BMI) category, lead-in body weight loss category, and baseline (Day 1) weight as a covariate. The p-value is for testing the null hypothesis of no difference between treatments. Analysis performed two-sided at a 5% significance level to compare treatment groups.||||0.0004
73994856|NCT02078492|147535535|NON_INFERIORITY_OR_EQUIVALENCE|We assumed a minimal clinically significant difference (MCSD) of 1.3 between the three ketorolac groups at the 30-minute pain assessment and a standard deviation of 3.0. A power analysis determined that a sample of 78 subjects per group provided at least 80% power to detect an MCSD of at least 1.3 at 30 minutes with α=0.05.||||||0.783|||||||ANOVA|2 degrees of freedom||The main hypothesis was that there would be equivalence of dose effect across the three groups at every time point, and the primary comparison consisted of the pain assessment at 30 minutes.||||.783
73994857|NCT01681277|147535591|SUPERIORITY_OR_OTHER||Slope|1.2208|STANDARD_ERROR_OF_MEAN|0.1386|||TWO_SIDED|95.0|0.9354|1.5062|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for Cmax,ss was analysed.||1.5062|0.9354|
73994858|NCT01681277|147535593|SUPERIORITY_OR_OTHER||Slope|1.3135|STANDARD_ERROR_OF_MEAN|0.1206|||TWO_SIDED|95.0|1.0652|1.5618|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for AUCt,ss was analysed.||1.5618|1.0652|
73994859|NCT04486625|147535598|OTHER|Analysis of variance (ANOVA) was used to compare the natural log transformed AUC0-24,ss between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% confidence intervals (CIs) for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|79.48|||||TWO_SIDED|90.0|66.52|94.96||||||||94.96|66.52|
73994860|NCT04486625|147535599|OTHER|ANOVA was used to compare the natural log transformed Cmax between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|75.58|||||TWO_SIDED|90.0|66.1|86.43||||||||86.43|66.10|
73994861|NCT04486625|147535600|OTHER|ANOVA was used to compare the natural log transformed AUC0-24,ss between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of of adjusted geometric means|124.19|||||TWO_SIDED|90.0|100.18|153.97||||||||153.97|100.18|
73994862|NCT04486625|147535601|OTHER|ANOVA was used to compare the natural log transformed Cmax between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|102.42|||||TWO_SIDED|90.0|87.55|119.83||||||||119.83|87.55|
73994863|NCT02271984|147535628|SUPERIORITY_OR_OTHER||Ratio (%)|39.9|||||TWO_SIDED|90.0|34.7|46.0|||||Percentage of Geometric Least Squares (LS) Mean Ratio (Treatment A/Treatment B) is reported.|||46.0|34.7|
73994864|NCT02271984|147535628|SUPERIORITY_OR_OTHER||Ratio (%)|27.3|||||TWO_SIDED|90.0|22.5|33.2|||||Percentage of Geometric LS Mean Ratio (Treatment C1/Treatment A) is reported.|||33.2|22.5|
73994865|NCT02271984|147535628|SUPERIORITY_OR_OTHER||Ratio (%)|260.2|||||TWO_SIDED|90.0|214.0|316.4|||||Percentage of Geometric LS Mean Ratio (Treatment C2/Treatment A) is reported.|||316.4|214.0|
73876833|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.3|-12.8|0.257
73876834|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|-20.0||||0.44|TWO_SIDED|95.0|-55.9|15.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||15.9|-55.9|0.440
73994866|NCT02271984|147535628|SUPERIORITY_OR_OTHER||Ratio (%)|167.1|||||TWO_SIDED|90.0|143.9|194.0|||||Percentage of Geometric LS Mean Ratio (Treatment A/Treatment D) is reported.|||194.0|143.9|
73994867|NCT02271984|147535628|SUPERIORITY_OR_OTHER||Ratio (%)|115.7|||||TWO_SIDED|90.0|99.8|134.1|||||Percentage of Geometric LS Mean Ratio (Treatment E/Treatment A) is reported.|||134.1|99.8|
73994868|NCT04024462|147535650|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8.|Geometric Mean Ratio|1.07|||||TWO_SIDED|90.0|0.99|1.15|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of pertuzumab (Arm B) relative to the pertuzumab IV dose (Arm A).|The null hypothesis was that the pertuzumab Arm B SC dose is inferior to the pertuzumab Arm A IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of pertuzumab relative to the IV dose is not greater than 0.8).||1.15|0.99|
74039735|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0025|TWO_SIDED|95.0|1.15|1.91|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.91|1.15|0.0025
73876835|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|-2.5||||1|TWO_SIDED|95.0|-24.3|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||19.3|-24.3|1.000
73994869|NCT04024462|147535651|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8. Non-inferiority was tested in hierarchical order after the primary outcome measure, to adjust for multiple statistical testing and control the type I error at one sided 5% significance level.|Geometric Mean Ratio|1.55|||||TWO_SIDED|90.0|1.44|1.67|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of trastuzumab (Arm B) relative to the trastuzumab IV dose (Arm A).|The null hypothesis was that the trastuzumab Arm B SC dose is inferior to the Arm A trastuzumab IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of trastuzumab relative to the IV dose is not greater than 0.8).||1.67|1.44|
73994870|NCT04024462|147535652|OTHER|Descriptive analysis only. tpCR was analyzed outside of a hypothesis-testing framework and according to the methodology outlined in the outcome measure description.|Difference in tpCR Rate|-0.88|||||TWO_SIDED|95.0|-15.21|13.45|||||Difference in tpCR rate was calculated as Arm B: PH FDC SC minus Arm A: P+H IV.|||13.45|-15.21|
73994871|NCT02870972|147535675|SUPERIORITY||Difference in Least Square Means|-0.458|||<|0.001|TWO_SIDED|95.0|-0.703|-0.214|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.214|-0.703|<0.001
73994872|NCT02870972|147535675|SUPERIORITY||Difference in Least Square Means|-0.433||||0.006|TWO_SIDED|95.0|-0.74|-0.127|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.127|-0.740|0.006
73994873|NCT02870972|147535675|SUPERIORITY||Difference in Least Square Means|-0.425||||0.012|TWO_SIDED|95.0|-0.755|-0.095|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.095|-0.755|0.012
73994874|NCT02870972|147535675|SUPERIORITY||Difference in Least Square Means|-0.703|||<|0.001|TWO_SIDED|95.0|-1.033|0.373|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.373|-1.033|<0.001
73994875|NCT02870972|147535675|SUPERIORITY||Difference in Least Square Means|-0.1||||0.639|TWO_SIDED|95.0|-0.52|0.32|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.32|-0.52|0.639
73994876|NCT02870972|147535676|SUPERIORITY||Difference vs placebo (%)|17.7||||0.155|TWO_SIDED|95.0|-3.4|38.8|||Fisher Exact|||||38.8|-3.4|0.155
73994877|NCT02870972|147535676|SUPERIORITY||Difference vs placebo (%)|16.9||||0.277|TWO_SIDED|95.0|-6.3|40.1|||Fisher Exact|||||40.1|-6.3|0.277
73994878|NCT02870972|147535676|SUPERIORITY||Difference vs placebo (%)|24.0||||0.064|TWO_SIDED|95.0|-1.2|49.2|||Fisher Exact|||||49.2|-1.2|0.064
73994879|NCT02870972|147535676|SUPERIORITY||Difference vs placebo (%)|-4.5||||1|TWO_SIDED|95.0|-13.2|4.2|||Fisher Exact|||||4.2|-13.2|1.000
73994880|NCT02870972|147535676|SUPERIORITY||Difference vs placebo (%)|-16.2||||0.097|TWO_SIDED|95.0|-30.2|-2.2|||Fisher Exact|||||-2.2|-30.2|0.097
73994881|NCT02870972|147535677|SUPERIORITY||Difference in Least Square Means|-0.061||||0.439|TWO_SIDED|95.0|-0.216|0.094|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.094|-0.216|0.439
74090175|NCT01763918|147733547|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.42|STANDARD_ERROR_OF_MEAN|3.77|<|0.001|TWO_SIDED|95.0|-52.86|-37.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-37.98|-52.86|<0.001
73994882|NCT02870972|147535677|SUPERIORITY||Difference in Least Square Means|-0.004||||0.968|TWO_SIDED|95.0|-0.198|0.19|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.190|-0.198|0.968
73994883|NCT02870972|147535677|SUPERIORITY||Difference in Least Square Means|-0.045||||0.667|TWO_SIDED|95.0|-0.254|0.164|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.164|-0.254|0.667
73994884|NCT02870972|147535677|SUPERIORITY||Difference in Least Square Means|-0.197||||0.065|TWO_SIDED|95.0|-0.406|0.012|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.012|-0.406|0.065
73994885|NCT02870972|147535677|SUPERIORITY||Difference in Least Square Means|0.035||||0.797|TWO_SIDED|95.0|-0.232|0.301|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.301|-0.232|0.797
73994886|NCT02870972|147535678|SUPERIORITY||Difference in Least Square Means|-0.364|||<|0.001|TWO_SIDED|95.0|-0.547|-0.181|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.181|-0.547|<0.001
73994887|NCT02870972|147535678|SUPERIORITY||Difference in Least Square Means|-0.384||||0.001|TWO_SIDED|95.0|-0.613|-0.154|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.154|-0.613|0.001
73994888|NCT02870972|147535678|SUPERIORITY||Difference in Least Square Means|-0.401||||0.002|TWO_SIDED|95.0|-0.647|-0.154|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.154|-0.647|0.002
73994889|NCT02870972|147535678|SUPERIORITY||Difference in Least Square Means|-0.445|||<|0.001|TWO_SIDED|95.0|-0.692|-0.198|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.198|-0.692|<0.001
73994890|NCT02870972|147535678|SUPERIORITY||Difference in Least Square Means|-0.08||||0.614|TWO_SIDED|95.0|-0.394|0.234|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.234|-0.394|0.614
73994891|NCT02870972|147535679|SUPERIORITY||Difference in Least Square Means|-0.326||||0.006|TWO_SIDED|95.0|-0.557|-0.095|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.095|-0.557|0.006
73994892|NCT02870972|147535679|SUPERIORITY||Difference in Least Square Means|-0.293||||0.047|TWO_SIDED|95.0|-0.582|0.004|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.004|-0.582|0.047
73876836|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.5|15.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.0|-16.5|1.000
73994893|NCT02870972|147535679|SUPERIORITY||Difference in Least Square Means|-0.327||||0.04|TWO_SIDED|95.0|-0.638|-0.016|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.016|-0.638|0.040
73994894|NCT02870972|147535679|SUPERIORITY||Difference in Least Square Means|-0.558|||<|0.001|TWO_SIDED|95.0|-0.87|-0.247|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.247|-0.870|<0.001
73994895|NCT02870972|147535679|SUPERIORITY||Difference in Least Square Means|0.057||||0.775|TWO_SIDED|95.0|-0.339|0.454|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.454|-0.339|0.775
73994896|NCT02870972|147535680|SUPERIORITY||Difference in Least Square Means|-4.449||||0.209|TWO_SIDED|95.0|-11.453|2.555|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.555|-11.453|0.209
73994897|NCT02870972|147535680|SUPERIORITY||Difference in Least Square Means|-9.103||||0.019|TWO_SIDED|95.0|-16.639|-1.567|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-1.567|-16.639|0.019
74035872|NCT00960934|147624180|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|23.38|||<|0.001|TWO_SIDED|95.0|11.02|35.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||35.82|11.02|<0.001
73876837|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|-20.0||||0.44|TWO_SIDED|95.0|-55.9|15.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.9|-55.9|0.440
73994898|NCT02870972|147535680|SUPERIORITY||Difference in Least Square Means|-11.263||||0.004|TWO_SIDED|95.0|-18.808|-3.718|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-3.718|-18.808|0.004
73994899|NCT02870972|147535680|SUPERIORITY||Difference in Least Square Means|4.04||||0.405|TWO_SIDED|95.0|-5.586|13.665|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||13.665|-5.586|0.405
73994900|NCT02870972|147535681|SUPERIORITY||Difference in Least Square Means|-8.12||||0.135|TWO_SIDED|95.0|-18.826|2.584|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.584|-18.826|0.135
74090176|NCT01763918|147733548|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.17|STANDARD_ERROR_OF_MEAN|2.62|<|0.001|TWO_SIDED|95.0|-58.35|-47.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-47.99|-58.35|<0.001
73994901|NCT02870972|147535681|SUPERIORITY||Difference in Least Square Means|-8.92||||0.121|TWO_SIDED|95.0|-20.26|2.41|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.410|-20.260|0.121
73994902|NCT02870972|147535681|SUPERIORITY||Difference in Least Square Means|-24.49|||<|0.001|TWO_SIDED|95.0|-35.834|-13.137|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-13.137|-35.834|<0.001
73994903|NCT02870972|147535681|SUPERIORITY||Difference in Least Square Means|-7.84||||0.284|TWO_SIDED|95.0|-22.316|6.64|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||6.640|-22.316|0.284
73994904|NCT02870972|147535682|SUPERIORITY||Difference in Least Square Means|-8.27||||0.067|TWO_SIDED|95.0|-17.132|0.592|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.592|-17.132|0.067
73994905|NCT02870972|147535682|SUPERIORITY||Difference in Least Square Means|-7.073||||0.136|TWO_SIDED|95.0|-16.432|2.287|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.287|-16.432|0.136
74035873|NCT00960934|147624180|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|10.45||||0.061|TWO_SIDED|95.0|-0.37|21.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||21.30|-0.37|0.061
74090177|NCT01763918|147733548|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-55.56|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-61.08|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.05|-61.08|<0.001
73994906|NCT02870972|147535682|SUPERIORITY||Difference in Least Square Means|-11.484||||0.015|TWO_SIDED|95.0|-20.642|-2.325|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-2.325|-20.642|0.015
73876838|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-28.7|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-28.7|1.000
73994907|NCT02870972|147535682|SUPERIORITY||Difference in Least Square Means|-9.785||||0.114|TWO_SIDED|95.0|-22.001|2.431|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.431|-22.001|0.114
73994908|NCT03559062|147535705|OTHER||||||<|0.0001|||||||Mixed-effects model for repeated measure|||||||<0.0001
73994909|NCT03559062|147535706|OTHER||||||<|0.0001|||||||Mixed-effects model for repeated measure|||||||<0.0001
73994910|NCT03559062|147535707|OTHER|||||||0.0546|||||||Mixed-effects model for repeated measure|||||||0.0546
73994911|NCT03445533|147535709|SUPERIORITY|||||||0.9394||||||p-value was calculated for percentage difference (B-A) using a Cochran-Mantel-Haenszel (CMH) test stratified by metastasis stage and BRAF mutation.|Cochran-Mantel-Haenszel|ORR and OS comprise a primary endpoint family; both have a priori hypotheses and were tested for statistical significance.||The ORR was defined as a percentage of subjects meeting criteria of CR and PR to calculate the p-value.||||0.9394
73994912|NCT03445533|147535710|SUPERIORITY||Cox Proportional Hazard|0.955||||0.6775|TWO_SIDED|95.0|0.77|1.186||The p-value was calculated using the log rank test stratified by metastasis stage and BRAF mutation.|Log Rank|ORR and OS comprise a primary endpoint family; both have a priori hypotheses. ORR will be tested first followed by OS.|Hazard ratio and 95% CI (B/A) are estimated using a Cox proportional hazards model stratified by metastasis stage and BRAF mutation.|||1.186|0.770|0.6775
73994913|NCT00874731|147535767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|||||TWO_SIDED|90.0|-2.8|3.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|3.76|-2.80|
73994914|NCT00874731|147535770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||||TWO_SIDED|95.0|-3.83|2.74|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|2.74|-3.83|
74035874|NCT00960934|147624180|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|6.31||||0.283|TWO_SIDED|95.0|-3.81|16.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||16.45|-3.81|0.283
74035875|NCT00960934|147624180|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|5.46||||0.283|TWO_SIDED|95.0|-3.39|14.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||14.31|-3.39|0.283
74035876|NCT00960934|147624181|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|56.77|||<|0.001|TWO_SIDED|95.0|37.62|76.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||76.35|37.62|<.001
74035877|NCT00960934|147624181|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|39.66|||<|0.001|TWO_SIDED|95.0|22.44|57.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||57.17|22.44|<.001
73994915|NCT00874731|147535771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-4.5|2.14|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|2.14|-4.50|
74035878|NCT00960934|147624181|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|20.68||||0.003|TWO_SIDED|95.0|5.72|35.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||35.78|5.72|0.003
74035879|NCT00960934|147624181|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.59||||0.265|TWO_SIDED|95.0|-4.81|22.05||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||22.05|-4.81|0.265
74035880|NCT00960934|147624181|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.39||||0.265|TWO_SIDED|95.0|-3.4|20.21||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||20.21|-3.40|0.265
74035881|NCT00960934|147624182|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|53.05|||<|0.001|TWO_SIDED|95.0|37.83|68.53||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||68.53|37.83|<0.001
74035882|NCT00960934|147624182|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|41.41|||<|0.001|TWO_SIDED|95.0|27.36|55.65||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||55.65|27.36|<0.001
74035883|NCT00960934|147624182|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|24.81|||<|0.001|TWO_SIDED|95.0|12.39|37.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||37.33|12.39|<0.001
74035884|NCT00960934|147624182|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|12.87||||0.02|TWO_SIDED|95.0|1.73|24.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||24.06|1.73|0.020
73994916|NCT00874731|147535772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-2.85|3.79|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|3.79|-2.85|
73994917|NCT00874731|147535773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|||||TWO_SIDED|95.0|-2.1|4.47|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|4.47|-2.10|
73994918|NCT00874731|147535774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||||TWO_SIDED|95.0|-0.79|5.78|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|5.78|-0.79|
73994919|NCT00874731|147535775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||||TWO_SIDED|95.0|-0.8|5.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|5.76|-0.80|
73994920|NCT00874731|147535776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.89|||||TWO_SIDED|95.0|0.6|7.17|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|7.17|0.60|
74035885|NCT00960934|147624182|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|4.02||||0.397|TWO_SIDED|95.0|-5.31|13.36||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||13.36|-5.31|0.397
74035886|NCT00839423|147624196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|1.42|<|0.0001|TWO_SIDED|95.0|-8.49|-2.91||"A hierarchical hypothesis testing procedure was used. The comparison of 10 mg to placebo was primary.~Since p-value was \<0.05, hierarchically testing continued."|ANCOVA|||"The statistical model was an analysis of covariance (ANCOVA) of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 6.~With 96 patients in each treatment arm and a standard deviation of 9 points, the power to detect a true effect of 3.7 points on the MADRS total score at Week 6 will be 80%."||-2.91|-8.49|<0.0001
74035887|NCT00839423|147624196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.39|<|0.0001|TWO_SIDED|95.0|-8.64|-3.17||"The hierarchical hypothesis testing meant that comparison of 5 mg to placebo was performed at a 5% significance level since significance was achieved for the primary comparison of 10 mg to placebo.~Since p-value \<0.05, hierarchically testing contd."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 6."||-3.17|-8.64|<0.0001
74035888|NCT00839423|147624196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-9.13|-3.72||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-3.72|-9.13|<0.0001
73876839|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|10.5||||0.404|TWO_SIDED|95.0|-14.0|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||34.9|-14.0|0.404
73994921|NCT00874731|147535777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-4.85|1.86|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|1.86|-4.85|
74035889|NCT00839423|147624197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.69||0.2377|TWO_SIDED|95.0|-2.17|0.54||"The hierarchical procedure meant that the above hypothesis was tested at a 5% significance level since significance was achieved for both 10 and 5 mg at Week 6.~Since p-value was \>0.05, hierarchically testing stopped here."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 1."||0.54|-2.17|0.2377
74035890|NCT00839423|147624197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.67||0.7489|TWO_SIDED|95.0|-1.54|1.11||The hierarchical procedure meant that the above hypothesis was not tested since significance was not achieved for 10 mg at Week 1. A nominal p-value is provided.|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 1."||1.11|-1.54|0.7489
74035891|NCT00839423|147624197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.67||0.4142|TWO_SIDED|95.0|-0.77|1.85||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||1.85|-0.77|0.4142
74035892|NCT00839423|147624198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.28|STANDARD_ERROR_OF_MEAN|1.22|<|0.0001|TWO_SIDED|95.0|-7.69|-2.88||A nominal p-value is provided.|ANCOVA|||||-2.88|-7.69|<0.0001
74035893|NCT00839423|147624198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.33|STANDARD_ERROR_OF_MEAN|1.25|<|0.0001|TWO_SIDED|95.0|-7.79|-2.88||A nominal p-value is provided.|ANCOVA|||||-2.88|-7.79|<0.0001
74035894|NCT00839423|147624199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.0||0.0011|TWO_SIDED|95.0|-5.27|-1.33||A nominal p-value is provided.|ANCOVA|||||-1.33|-5.27|0.0011
74035895|NCT00839423|147624199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.02||0.0034|TWO_SIDED|95.0|-5.01|-1.0||A nominal p-value is provided.|ANCOVA|||||-1.00|-5.01|0.0034
74035896|NCT00839423|147624200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.28|-0.52||A nominal p-value is provided.|ANCOVA|||||-0.52|-1.28|<0.0001
73994922|NCT00955708|147535778|OTHER|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|95.3|||||ONE_SIDED|95.0|94.0||||||The lower one-sided 95% confidence bound was pre-specified to be greater than 92.5%.|The endpoint data reflected here is a modified primary endpoint analysis requested by the Food and Drug Administration early in the registry to include data that is related to the left ventricular lead function in a chronic setting.|||94.0|
73994923|NCT00955708|147535778|OTHER|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|100.0|||||ONE_SIDED|95.0|100.0|||||||The non-modified primary endpoint analysis initially included confirmed chronic LV lead related complications that result in permanent loss of therapy, invasive intervention, injury or death, and are deemed attributable to a structural lead failure by an independent Clinical Events Committee (CEC). These results are represented here.|||100|
73994924|NCT01016262|147535796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between MAX-002 and placebo during the DB phase with respect to the primary outcome measure was the single pre-specified primary analysis, and the null hypothesis was that the percentages were equal between the two groups.||||0.0047
73994925|NCT01016262|147535796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0346||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between Canasa® and placebo during the DB phase with respect to the primary outcome measure was a pre-specified tertiary analysis only.||||0.0346
73994926|NCT00479882|147535816|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least squares mean|2.4|||||TWO_SIDED|95.0|1.3|3.4|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||3.4|1.3|
73994927|NCT00479882|147535816|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least Squares Mean|1.4|||||TWO_SIDED|95.0|0.4|2.4|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||2.4|0.4|
73994928|NCT00479882|147535817|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.2|||||TWO_SIDED|95.0|-1.4|1.0|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||1.0|-1.4|
73994929|NCT00479882|147535817|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.8|||||TWO_SIDED|95.0|-1.9|0.2|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||0.2|-1.9|
73994930|NCT00479882|147535818|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2||||0.685|TWO_SIDED|95.0|-1.2|0.8|||Fisher Exact||Wilson's Method|Periods I/II||0.8|-1.2|0.685
73994931|NCT00479882|147535818|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.8|1.1|||||Wilson's Method|Period III||1.1|-1.8|
73994932|NCT00479882|147535818|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3||||0.753|TWO_SIDED|95.0|-1.6|0.9|||Fisher Exact||Wilson's Method|Periods I/II||0.9|-1.6|0.753
73994933|NCT00479882|147535818|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.8|1.4|||||Wilson's Method|Period III||1.4|-0.8|
74035897|NCT00839423|147624200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.34|-0.56||A nominal p-value is provided.|ANCOVA|||||-0.56|-1.34|<0.0001
73994934|NCT00479882|147535819|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
73994935|NCT00479882|147535819|SUPERIORITY_OR_OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-0.5|1.5|||||Wilson's Method|Period III||1.5|-0.5|
73994936|NCT00479882|147535819|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.617|TWO_SIDED|95.0|-0.6|1.1|||Fisher Exact||Wilson's Method|Periods I/II||1.1|-0.6|0.617
73994937|NCT00479882|147535819|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
73994938|NCT00479882|147535820|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
73994939|NCT00479882|147535820|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.9|0.8|||||Wilson's Method|Period III||0.8|-0.9|
73994940|NCT00479882|147535820|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.7|||Fisher Exact||Wilson's Method|Periods I/II||0.7|-0.6|
74035898|NCT00839423|147624201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.9|-0.27||A nominal p-value is provided.|ANCOVA|||||-0.27|-0.90|0.0003
74035899|NCT00839423|147624201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.92|-0.27||A nominal p-value is provided.|ANCOVA|||||-0.27|-0.92|0.0003
73994941|NCT00479882|147535820|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
73994942|NCT00479882|147535821|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
73994943|NCT00479882|147535821|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.9|0.8|||||Wilson's Method|Period III||0.8|-0.9|
73994944|NCT00479882|147535821|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.7|||Fisher Exact||Wilson's Method|Periods I/II||0.7|-0.6|
73994945|NCT00479882|147535821|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
73994946|NCT00479882|147535822|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2||||0.497|TWO_SIDED|95.0|-0.9|0.5|||Fisher Exact|||Periods I/II||0.5|-0.9|0.497
73994947|NCT00479882|147535823|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3||||0.449|TWO_SIDED|95.0|-1.4|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-1.4|0.449
74035900|NCT00839423|147624202|SUPERIORITY_OR_OTHER||Difference %|21.9||||0.002|TWO_SIDED|95.0|8.89|34.92||A nominal p-value is provided.|Fisher Exact|||||34.92|8.89|0.002
74090178|NCT01763918|147733549|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.28|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-60.16|-48.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-48.41|-60.16|<0.001
73994948|NCT00479882|147535823|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.6|0.9|||||Wilson's Method|Period III||0.9|-1.6|
73994949|NCT00479882|147535823|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.685|TWO_SIDED|95.0|-0.8|1.2|||Fisher Exact||Wilson's Method|Period I/II||1.2|-0.8|0.685
73994950|NCT00479882|147535823|SUPERIORITY_OR_OTHER||Difference in Percentage|0.3|||||TWO_SIDED|95.0|-1.0|1.6|||||Wilson's Method|Period III||1.6|-1.0|
73994951|NCT00479882|147535824|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.2||||0.02|TWO_SIDED|95.0|-2.4|-0.2|||Fisher Exact||Wilson's Method|Periods I/II||-0.2|-2.4|0.020
73994952|NCT00479882|147535824|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.6|0.9|||||Wilson's Method|Period III||0.9|-1.6|
73994953|NCT00479882|147535824|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.5||||0.452|TWO_SIDED|95.0|-1.6|0.5|||Fisher Exact||Wilson's Method|Periods I/II||0.5|-1.6|0.452
73994954|NCT00479882|147535824|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4|||||TWO_SIDED|95.0|-1.9|1.0|||||Wilson's Method|Period III||1.0|-1.9|
73994955|NCT00479882|147535825|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||||Wilson's Method|Periods I/II||0.6|-0.6|
73994956|NCT00479882|147535825|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.7|1.2|||||Wilson's Method|Period III||1.2|-0.7|
73994957|NCT00479882|147535825|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.5|0.9|||||Wilson's Method|Periods I/II||0.9|-0.5|
73994958|NCT00479882|147535825|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.6|1.3|||||Wilson's Method|Period III||1.3|-0.6|
73994959|NCT00479882|147535826|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.4|||||TWO_SIDED|95.0|-6.6|3.8|||||Wilson's Score Method|Periods I/II||3.8|-6.6|
73994960|NCT00479882|147535826|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.9|||||TWO_SIDED|95.0|-8.1|4.3|||||Wilson's Score Method|Period III||4.3|-8.1|
73994961|NCT00479882|147535826|SUPERIORITY_OR_OTHER||Difference in Percentage|0.1|||||TWO_SIDED|95.0|-5.2|5.3|||||Wilson's Score Method|Periods I/II||5.3|-5.2|
73994962|NCT00479882|147535826|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8|||||TWO_SIDED|95.0|-8.9|3.4|||||Wilson's Score Method|Period III||3.4|-8.9|
73994963|NCT00479882|147535827|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||TWO_SIDED|95.0|-2.5|2.1|||||Wilson's Score Method|Periods I/II||2.1|-2.5|
73994964|NCT00479882|147535827|SUPERIORITY_OR_OTHER||Difference in Percentage|2.3|||||TWO_SIDED|95.0|-0.5|5.2|||||Wilson's Score Method|Period III||5.2|-0.5|
73994965|NCT00479882|147535827|SUPERIORITY_OR_OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-1.0|4.2|||||Wilson's Score Method|Periods I/II||4.2|-1.0|
73994966|NCT00479882|147535827|SUPERIORITY_OR_OTHER||Difference in Percentage|2.0|||||TWO_SIDED|95.0|-0.8|5.0|||||Wilson's Score Method|Period III||5.0|-0.8|
73994967|NCT00479882|147535830|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.5|0.9|||||Wilson's Score Method|Periods I/II||0.9|-0.5|
73994968|NCT00479882|147535830|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||||Wilson's Score Method|Periods I/II||0.5|-0.9|
73994969|NCT00479882|147535831|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.0||||0.341|TWO_SIDED|95.0|-1.1|3.1|||ANOVA|Factors for treatment, country and gender||||3.1|-1.1|0.341
73994970|NCT00479882|147535831|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.7||||0.004|TWO_SIDED|95.0|1.2|6.1|||ANOVA|Factors for treatment, country and gender.||||6.1|1.2|0.004
73994971|NCT00479882|147535832|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.4||||0.69|TWO_SIDED|95.0|-2.3|1.5|||ANOVA|Factors for treatment, country and gender||||1.5|-2.3|0.690
73994972|NCT00479882|147535832|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.2||||0.879|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|Factors for treatment, country and gender||||2.3|-1.9|0.879
73994973|NCT01370655|147535850|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis supported if the upper bound of the two-sided 80% confidence interval (CI; equivalent to a one-sided upper 90% CI) is~≤0 mmHg"|Difference in Least square (LS) means|-7.4|||||TWO_SIDED|80.0|-10.6|-4.1|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.||-4.1|-10.6|
73994974|NCT01370655|147535850|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis supported if the upper bound of the two-sided 90% CI (equivalent to a one-sided upper 95% CI) for the difference ≤ 3.8 mmHg.|Difference in LS means|-5.4|||||TWO_SIDED|90.0|-9.2|-1.6|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|Type I error rate of alpha=0.05 (1-sided) is specified for testing of the hypothesis.||-1.6|-9.2|
73994975|NCT01370655|147535850|SUPERIORITY_OR_OTHER||Difference in LS means|-4.8|||||TWO_SIDED|90.0|-9.0|-0.5|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-0.5|-9.0|
73994976|NCT01370655|147535850|SUPERIORITY_OR_OTHER||Difference in LS Means|-6.7|||||TWO_SIDED|90.0|-11.2|-2.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||-2.2|-11.2|
73994977|NCT01370655|147535850|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9|||||TWO_SIDED|90.0|-6.2|2.3|||||HCTZ 25 mg LS mean minus Placebo LS mean|||2.3|-6.2|
73994978|NCT01370655|147535851|SUPERIORITY_OR_OTHER||Difference in LS means|-3.2|||||TWO_SIDED|90.0|-6.1|-0.3|||||MK-7145 6 mg LS mean minus Placebo LS mean|||-0.3|-6.1|
73994979|NCT01370655|147535851|SUPERIORITY_OR_OTHER||Difference in LS means|-2.9|||||TWO_SIDED|90.0|-5.5|-0.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||-0.2|-5.5|
73994980|NCT01370655|147535851|SUPERIORITY_OR_OTHER||Difference in LS means|-3.0|||||TWO_SIDED|90.0|-6.0|-0.1|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-0.1|-6.0|
73994981|NCT01370655|147535851|SUPERIORITY_OR_OTHER||Difference in LS means|-3.4|||||TWO_SIDED|90.0|-6.5|-0.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||-0.2|-6.5|
74090179|NCT01763918|147733549|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.55|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-58.14|-40.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-40.96|-58.14|<0.001
73994982|NCT01370655|147535851|SUPERIORITY_OR_OTHER||Difference in LS means|-0.3|||||TWO_SIDED|90.0|-3.3|2.7|||||HCTZ 25 mg LS mean minus Placebo LS mean|||2.7|-3.3|
73994983|NCT01370655|147535852|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis supported if the lower bound of the two-sided 80% CI (equivalent to a one-sided lower 90% CI) is \> 89.0 mmol/day.|Difference in LS means|76.5|||||TWO_SIDED|80.0|49.2|103.8|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.||103.8|49.2|
73994984|NCT01370655|147535852|SUPERIORITY_OR_OTHER||Difference in LS means|-63.7|||||TWO_SIDED|90.0|-100.8|-26.7|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-26.7|-100.8|
73994985|NCT01370655|147535852|SUPERIORITY_OR_OTHER||Difference in LS means|-18.1|||||TWO_SIDED|90.0|-49.1|12.9|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||12.9|-49.1|
73994986|NCT01370655|147535852|SUPERIORITY_OR_OTHER||Difference in LS means|30.9|||||TWO_SIDED|90.0|-7.0|68.7|||||MK-7145 3 mg LS mean minus Placebo LS mean|||68.7|-7.0|
73994987|NCT01370655|147535852|SUPERIORITY_OR_OTHER||Difference in LS means|94.6|||||TWO_SIDED|90.0|58.8|130.4|||||HCTZ 25 mg LS mean minus Placebo LS mean|||130.4|58.8|
73994988|NCT01370655|147535856|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is \<13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 - placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|7.9|||||TWO_SIDED|80.0|-2.3|18.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||18.2|-2.3|
73994989|NCT01370655|147535856|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is \<13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 - placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|1.1|||||TWO_SIDED|80.0|-8.5|10.7|||||MK-7145 6 mg LS mean minus Placebo LS mean|||10.7|-8.5|
73994990|NCT01370655|147535856|SUPERIORITY_OR_OTHER||Difference in LS means|3.0|||||TWO_SIDED|90.0|-9.6|15.6|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||15.6|-9.6|
73994991|NCT01370655|147535856|SUPERIORITY_OR_OTHER||Difference in LS means|-3.9|||||TWO_SIDED|90.0|-15.0|7.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||7.2|-15.0|
73994992|NCT01370655|147535856|SUPERIORITY_OR_OTHER||Difference in LS means|5.0|||||TWO_SIDED|90.0|-7.7|17.6|||||HCTZ 25 mg LS mean minus Placebo LS mean|||17.6|-7.7|
73994993|NCT03119233|147535916|OTHER||Lower 97.5% Exact Confidence Limit|68.1|||||ONE_SIDED|97.5|60.9|||||||"The primary effectiveness endpoint is defined as primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR)~≤2.5 from DUS and no clinically-driven re-intervention within the stented segment. The primary effectiveness endpoint hypotheses are:~* H0: 12-month success rate of the PQ Bypass System ≤60.4%~* HA: 12-month success rate of the PQ Bypass System \>60.4%"|||60.9|
74035901|NCT00839423|147624202|SUPERIORITY_OR_OTHER||Difference %|23.34||||0.001|TWO_SIDED|95.0|10.05|36.43||A nominal p-value is provided.|Fisher Exact|||||36.43|10.05|0.001
73994994|NCT03119233|147535917|OTHER|The rate of freedom from 30-day MAE is expected to be no less than 92%. Based on a PG of 84% and an estimated 30-day freedom from MAE rate of 92% for the PQ Bypass System, a sample size of 169 evaluable subjects provides 88% power to test the primary safety hypothesis at the one-sided alpha level of 0.025. The Exact Test Method and Commercial software PASS14 was used to determine the sample size.|Lower 97.5% Exact Confidence Limit|93.0|||||ONE_SIDED|97.5|88.5|||||||"The primary safety endpoint hypotheses are:~* H0: 30-day Freedom from MAE rate of the PQ Bypass System~  ≤84%~* HA: 30-day Freedom from MAE rate of the PQ Bypass System \>84%"|||88.5|
73994995|NCT02057575|147535921|SUPERIORITY||||||<|0.0001||||||PG324 0.01% vs netarsudil|t-test, 2 sided|||||||<0.0001
73994996|NCT02057575|147535921|SUPERIORITY||||||<|0.0001||||||PG324 0.02% vs. netarsudil|t-test, 2 sided|||||||<0.0001
73994997|NCT02057575|147535921|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 0.01% vs. latanoprost||||||<0.0001
73994998|NCT02057575|147535921|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 0.02% vs. latanoprost||||||<0.0001
73994999|NCT01735175|147535925|EQUIVALENCE|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|TWO_SIDED|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|The difference between LA-EP2006 and reference pegfilgrastim was 0.07 days (95% CI \[-0.12, 0.26\]). 95% CIs were within the predefined margin of ±1 day confirming equivalence.|"The hierarchical test procedure aimed to show that~1. LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~2. LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."||0.26|-0.12|0.05
73995000|NCT01735175|147535925|NON_INFERIORITY|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|TWO_SIDED|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|LA-EP2006 is non-inferior to Neulasta® because the lower bound of the 95% CI is entirely above the non-inferiority margin of -0.6 days.|"The hierarchical test procedure aimed to show that~1. LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~2. LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."||0.26|-0.12|0.05
73995001|NCT00659880|147535933|SUPERIORITY_OR_OTHER|||||||0.06|||||||Friedman|||||||0.06
74035902|NCT00839423|147624203|SUPERIORITY_OR_OTHER||Difference %|22.41||||0.001|TWO_SIDED|95.0|9.74|35.07||A nominal p-value is provided.|Fisher Exact|||||35.07|9.74|0.001
74035903|NCT00839423|147624203|SUPERIORITY_OR_OTHER||Difference %|22.33||||0.001|TWO_SIDED|95.0|9.39|35.28||A nominal p-value is provided.|Fisher Exact|||||35.28|9.39|0.001
74035904|NCT04348656|147624204|SUPERIORITY||Risk Ratio (RR)|1.16||||0.18|TWO_SIDED|95.0|0.94|1.43|||wald test|||||1.43|0.94|0.18
74035905|NCT04348656|147624205|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.3|TWO_SIDED|95.0|0.89|1.47|||Regression, Cox|||||1.47|0.89|0.30
74035906|NCT04348656|147624206|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.41|TWO_SIDED|95.0|-2.1|0.7|||t-test, 2 sided|bootstrap estimates based on resampling process|bootstrap estimates based on resampling process|||0.7|-2.1|0.41
74035907|NCT04348656|147624207|SUPERIORITY||Risk Ratio (RR)|1.12||||0.4|TWO_SIDED|95.0|0.86|1.46|||wald test|||||1.46|0.86|0.40
74035908|NCT04348656|147624208|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.22|TWO_SIDED|95.0|-0.3|1.7|||t-test, 2 sided|||||1.7|-0.3|0.22
74035909|NCT04348656|147624209|SUPERIORITY||Risk Ratio (RR)|0.83||||0.72|TWO_SIDED|95.0|0.31|2.27|||t-test, 2 sided|bootstrap estimates based on resampling process|bootstrap estimates based on resampling process|||2.27|0.31|0.72
73995002|NCT01266161|147535956|SUPERIORITY||Mean Difference (Final Values)|23.76|||<|0.001|TWO_SIDED|95.0|16.45|31.07||p-Value from analysis of variance (ANOVA) model, with treatment, baseline PSR, gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA|||||31.07|16.45|<0.001
73995003|NCT01266161|147535957|SUPERIORITY||Mean Difference (Final Values)|8.42|||<|0.001|TWO_SIDED|95.0|4.13|12.71||p-Value from ANOVA model, with treatment, baseline PSR, and gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA|||||12.71|4.13|<0.001
73995004|NCT01266161|147535958|SUPERIORITY||Least-squares means|8.95|||<|0.001|TWO_SIDED|95.0|5.94|11.95||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-12.||11.95|5.94|<0.001
73995005|NCT01266161|147535958|SUPERIORITY||Least-squares means|3.15|||<|0.001|TWO_SIDED|95.0|1.45|4.85||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 8-12.||4.85|1.45|<0.001
74035910|NCT04348656|147624212|SUPERIORITY||Risk Ratio (RR)|1.13||||0.33|TWO_SIDED|95.0|0.88|1.45|||wald test|||||1.45|0.88|0.33
74035911|NCT04348656|147624213|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.91|TWO_SIDED|95.0|0.76|1.35|||Regression, Cox|competing risk analysis|competing risk analysis|||1.35|0.76|0.91
73995006|NCT01266161|147535958|SUPERIORITY||Least-squares means|6.56|||<|0.001|TWO_SIDED|95.0|2.84|10.27||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 12-24.||10.27|2.84|<0.001
73995007|NCT01266161|147535958|SUPERIORITY||Least-squares means|2.02||||0.091|TWO_SIDED|95.0|-0.33|4.37||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 20-24.||4.37|-0.33|0.091
74035912|NCT04348656|147624214|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.18|TWO_SIDED|95.0|0.8|1.04|||Regression, Cox|||||1.04|0.80|0.18
74035913|NCT04348656|147624215|SUPERIORITY||Risk Ratio (RR)|1.53||||0.03|TWO_SIDED|95.0|1.04|2.26|||wald test|||||2.26|1.04|0.03
74035914|NCT04348656|147624215|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.02|TWO_SIDED|95.0|1.08|2.69|||Regression, Cox|competing risk analysis|competing risk analysis|The cumulative incidence of Grade 3 and 4 serious AEs is described as a hazard ratio.||2.69|1.08|0.02
74035915|NCT04348656|147624217|SUPERIORITY||Risk Ratio (RR)|1.27||||0.03|TWO_SIDED|95.0|1.02|1.57|||wald test|||||1.57|1.02|0.03
74035916|NCT04348656|147624220|OTHER|Incremental cost per quality-adjusted life day gained (ICER)- this is a summary measure of the cost-effectiveness of the intervention, compared to the control group. This is calculated using the cost (derived from cost of the intervention and cost of hospital stay based on the payer's perspective) per patient and the quality-adjusted life days calculated using the EQ-5D-5L results.|ICER (CAD)|-44623.01|||||TWO_SIDED|95.0|-525369.24|436123.22|||||ICER is reported in Canadian dollars. 95% CI is calculated by 1000 bootstrap sampling using bias-corrected accelerated method.|||436123.22|-525369.24|
73995008|NCT01266161|147535958|SUPERIORITY||Least-squares means|14.95|||<|0.001|TWO_SIDED|95.0|9.12|20.79||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-24.||20.79|9.12|<0.001
74035917|NCT03072719|147624221|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.19||||0.1774|TWO_SIDED|95.0|-0.46|0.09||From ANCOVA model: Treatment as fixed factor, baseline Schiff Sensitivity score as covariate.|ANCOVA||Difference is 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"H0 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is zero.~H1 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is not zero."||0.09|-0.46|0.1774
74035918|NCT02387372|147624242|OTHER||Geometric least squares mean ratio (GMR)|1.38|||||TWO_SIDED|90.0|1.21|1.56|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.56|1.21|
74035919|NCT02387372|147624242|OTHER||GMR|1.15|||||TWO_SIDED|90.0|1.03|1.29|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.29|1.03|
74035920|NCT02387372|147624245|OTHER||Geometric least squares mean ratio (GMR)|1.71|||||TWO_SIDED|90.0|1.5|1.96|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.96|1.50|
74035921|NCT02387372|147624245|OTHER||GMR|1.33|||||TWO_SIDED|90.0|1.14|1.55|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.55|1.14|
74035922|NCT02387372|147624247|OTHER||Geometric least squares mean ratio (GMR)|1.61|||||TWO_SIDED|90.0|1.44|1.81|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.81|1.44|
74035923|NCT02387372|147624247|OTHER||GMR|1.24|||||TWO_SIDED|90.0|1.11|1.39|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.39|1.11|
74035924|NCT02387372|147624248|OTHER||Geometric least squares mean ratio (GMR)|1.71|||||TWO_SIDED|90.0|1.51|1.95|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.95|1.51|
74035925|NCT02387372|147624248|OTHER||GMR|1.2|||||TWO_SIDED|90.0|1.09|1.33|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.33|1.09|
74035926|NCT03709810|147624337|SUPERIORITY||Geometric Mean Ratio|0.19|||<|0.0001|TWO_SIDED|95.0|0.12|0.3|||ANOVA|Log10 peanuts mass as response variable, study product and period as fixed explanatory effects, and participant as a random effect.|GMR=(Experimental denture adhesive/ No Adhesive)|||0.30|0.12|<0.0001
74035927|NCT02175771|147624362|SUPERIORITY||geometric mean ratio|1.32|||||TWO_SIDED|90.0|1.02|1.72|||||Fp MDPI / FLOVENT HFA|Mid-strength comparison||1.72|1.02|
74035928|NCT02175771|147624362|SUPERIORITY||geometric mean ratio|0.81|||||TWO_SIDED|90.0|0.63|1.04|||||Fp MDPI / FLOVENT HFA|High-strength comparison||1.04|0.63|
73995009|NCT01266161|147535958|SUPERIORITY||Least-squares means|5.87||||0.01|TWO_SIDED|95.0|1.42|10.33||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-36.||10.33|1.42|0.010
73995010|NCT01266161|147535958|SUPERIORITY||Least-squares means|3.48||||0.004|TWO_SIDED|95.0|1.13|5.83||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 32-36.||5.83|1.13|0.004
73995011|NCT01266161|147535958|SUPERIORITY||Least-squares means|6.09||||0.006|TWO_SIDED|95.0|1.82|10.36||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 36-48.||10.36|1.82|0.006
73995012|NCT01266161|147535958|SUPERIORITY||Least-squares means|2.41||||0.042|TWO_SIDED|95.0|0.09|4.73||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 44-48.||4.73|0.09|0.042
73995013|NCT01266161|147535958|SUPERIORITY||Least-squares means|10.97||||0.004|TWO_SIDED|95.0|3.49|18.45||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-48.||18.45|3.49|0.004
73995014|NCT01266161|147535959|SUPERIORITY||Hazard Ratio (HR)|0.18|||<|0.001||95.0|0.1|0.34|||proportional hazards model|||||0.34|0.10|<0.001
73995015|NCT01266161|147535960|SUPERIORITY||Treatment Difference|-48.01|||<|0.001||95.0|-64.46|-31.56||p-Values from the Cochran-Mantel-Haenszel (CMH) test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the first dosing interval (0 to 12 hours).||-31.56|-64.46|<0.001
73995016|NCT01266161|147535960|SUPERIORITY||Treatment Difference|-25.53|||<|0.001||95.0|-39.78|-11.28||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the second dosing interval (12 to 24 hours).||-11.28|-39.78|<0.001
73995017|NCT01266161|147535960|SUPERIORITY||Treatment Difference|-24.05||||0.002||95.0|-38.93|-9.18||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the third dosing interval (24 to 36 hours).||-9.18|-38.93|0.002
73995018|NCT01266161|147535960|SUPERIORITY||Treatment Difference|-13.6||||0.035||95.0|-26.41|-0.79||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the fourth dosing interval (36 to 48 hours).||-0.79|-26.41|0.035
73995019|NCT01266161|147535960|SUPERIORITY||Treatment Difference|-48.01|||<|0.001||95.0|-64.42|-31.6||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the study overall (0 to 48 hours).||-31.60|-64.42|<0.001
73995020|NCT01266161|147535960|SUPERIORITY||Cox proportional hazard models|0.086||||0.011|TWO_SIDED|95.0|0.01|0.57|||Andersen-Gill (AG)|||Time to First Dose Rescue Medication Over Entire Study Period (0-48 Hours)||0.57|0.01|0.011
73995021|NCT01266161|147535961|SUPERIORITY||Least squares means|0.84|||<|0.001||95.0|0.5|1.19||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||1.19|0.50|<0.001
74035929|NCT02175771|147624362|SUPERIORITY||geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.75|1.24|||||FS MDPI / ADVAIR DISKUS|Mid-strength comparison||1.24|0.75|
73995022|NCT01266161|147535961|SUPERIORITY||Least squares means|1.53|||<|0.001||95.0|1.11|1.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||1.94|1.11|<0.001
74035930|NCT02175771|147624362|SUPERIORITY||geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.67|1.06|||||FS MDPI / ADVAIR DISKUS|High-strength comparison||1.06|0.67|
73995023|NCT01266161|147535961|SUPERIORITY||Least squares means|2.0|||<|0.001||95.0|1.56|2.44||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||2.44|1.56|<0.001
73995024|NCT01266161|147535961|SUPERIORITY||Least squares means|2.29|||<|0.001||95.0|1.86|2.73||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||2.73|1.86|<0.001
73995025|NCT01266161|147535961|SUPERIORITY||Least squares means|2.18|||<|0.001||95.0|1.69|2.68||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||2.68|1.69|<0.001
73995026|NCT01266161|147535961|SUPERIORITY||Least squares means|0.92|||<|0.001||95.0|0.46|1.38||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on least-squares means from the ANOVA model.|Ibuprofen versus placebo at 6 hours.||1.38|0.46|<0.001
73995027|NCT01266161|147535961|SUPERIORITY||Least squares means|1.04|||<|0.001||95.0|0.54|1.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||1.54|0.54|<0.001
73995028|NCT01266161|147535961|SUPERIORITY||Least squares means|1.1|||<|0.001||95.0|0.59|1.6||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||1.60|0.59|<0.001
73995029|NCT01266161|147535961|SUPERIORITY||Least squares means|0.5||||0.052||95.0|0.0|1.01||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||1.01|-0.00|0.052
73995030|NCT01266161|147535962|SUPERIORITY||Least squares means|0.37|||<|0.001||95.0|0.16|0.59||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||0.59|0.16|<0.001
73995031|NCT01266161|147535962|SUPERIORITY||Least squares means|0.9|||<|0.001||95.0|0.63|1.18||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||1.18|0.63|<0.001
73995032|NCT01266161|147535962|SUPERIORITY||Least squares means|1.22|||<|0.001||95.0|0.91|1.52||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||1.52|0.91|<0.001
74035931|NCT02175771|147624363|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.009|STANDARD_ERROR_OF_MEAN|0.0476||0.8451|TWO_SIDED|95.0|-0.084|0.103|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|Mid-strength comparison||0.103|-0.084|0.8451
74035932|NCT02175771|147624363|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|-0.013|STANDARD_ERROR_OF_MEAN|0.0479||0.7877|TWO_SIDED|95.0|-0.107|0.081|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|High-strength comparison||0.081|-0.107|0.7877
73995033|NCT01266161|147535962|SUPERIORITY||Least squares means|1.4|||<|0.001||95.0|1.1|1.71||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||1.71|1.10|<0.001
73995034|NCT01266161|147535962|SUPERIORITY||Least squares means|1.32|||<|0.001||95.0|0.97|1.67||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||1.67|0.97|<0.001
73995035|NCT01266161|147535962|SUPERIORITY||Least squares means|0.61|||<|0.001||95.0|0.3|0.91||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.||0.91|0.30|<0.001
73995036|NCT01266161|147535962|SUPERIORITY||Least squares means|0.64|||<|0.001||95.0|0.31|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||0.97|0.31|<0.001
73995037|NCT01266161|147535962|SUPERIORITY||Least squares means|0.66|||<|0.001||95.0|0.36|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||0.97|0.36|<0.001
73995038|NCT01266161|147535962|SUPERIORITY||Least squares means|0.27||||0.089||95.0|-0.04|0.59||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||0.59|-0.04|0.089
73995039|NCT01266161|147535962|SUPERIORITY||Least squares means|1.0|||<|0.001||95.0|0.7|1.29||Ibuprofen versus placebo at 0.5 hours.|ANOVA|||Ibuprofen versus placebo at 16 hours.||1.29|0.70|<0.001
73995040|NCT01266161|147535962|SUPERIORITY||Least squares means|0.47||||0.004||95.0|0.15|0.78||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 20 hours.||0.78|0.15|0.004
73995041|NCT01266161|147535962|SUPERIORITY||Least squares means|0.04||||0.821||95.0|-0.28|0.35||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 24 hours.||0.35|-0.28|0.821
73995042|NCT01266161|147535962|SUPERIORITY||Least squares means|0.56||||0.001||95.0|0.23|0.9||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 28 hours.||0.90|0.23|0.001
73995043|NCT01266161|147535962|SUPERIORITY||Least squares means|0.62|||<|0.001||95.0|0.3|0.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 32 hours.||0.94|0.30|<0.001
73995044|NCT01266161|147535962|SUPERIORITY||Least squares means|0.25||||0.127||95.0|-0.07|0.57||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 36 hours.||0.57|-0.07|0.127
73995045|NCT01266161|147535962|SUPERIORITY||Least squares means|0.67|||<|0.001||95.0|0.35|1.0||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 40 hours.||1.00|0.35|<0.001
73995046|NCT01266161|147535962|SUPERIORITY||Least squares means|0.34||||0.036||95.0|0.02|0.67||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 44 hours.||0.67|0.02|0.036
73995047|NCT01266161|147535962|SUPERIORITY||Least squares means|0.26||||0.091||95.0|-0.04|0.56||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 48 hours.||0.56|-0.04|0.091
73995048|NCT01266161|147535963|SUPERIORITY||Least squares means|1.22|||<|0.001||95.0|0.69|1.74||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||1.74|0.69|<0.001
73995049|NCT01266161|147535963|SUPERIORITY||Least squares means|2.43|||<|0.001||95.0|1.77|3.09||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||3.09|1.77|<0.001
73995050|NCT01266161|147535963|SUPERIORITY||Least squares means|3.22|||<|0.001||95.0|2.49|3.95||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||3.95|2.49|<0.001
73995051|NCT01266161|147535963|SUPERIORITY||Least squares means|3.7|||<|0.001||95.0|2.98|4.42||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||4.42|2.98|<0.001
73995052|NCT01266161|147535963|SUPERIORITY||Least squares means|3.5|||<|0.001||95.0|2.67|4.33||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||4.33|2.67|<0.001
73995053|NCT01266161|147535963|SUPERIORITY||Least squares means|1.53|||<|0.001||95.0|0.79|2.27||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.||2.27|0.79|<0.001
73995054|NCT01266161|147535963|SUPERIORITY||Least squares means|1.67|||<|0.001||95.0|0.87|2.48||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||2.48|0.87|<0.001
73995055|NCT01266161|147535963|SUPERIORITY||Least squares means|1.76|||<|0.001||95.0|0.97|2.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||2.54|0.97|<0.001
73995056|NCT01266161|147535963|SUPERIORITY||Least squares means|0.78||||0.056||95.0|-0.02|1.58||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||1.58|-0.02|0.056
73995057|NCT01266161|147535964|SUPERIORITY||Least squares means|14.82|||<|0.001|TWO_SIDED|95.0|10.38|19.25||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0 to 12 hours.||19.25|10.38|<0.001
73995058|NCT01266161|147535964|SUPERIORITY||Least squares means|5.27|||<|0.001|TWO_SIDED|95.0|2.57|7.98||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo from 8 to 12 hours.||7.98|2.57|<0.001
73995059|NCT01266161|147535965|SUPERIORITY||CMH-adjusted proportion|-0.73|||<|0.001|TWO_SIDED|95.0|-0.91|-0.55||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the first dosing interval.||-0.55|-0.91|<0.001
73995060|NCT01266161|147535965|SUPERIORITY||CMH-adjusted proportions|-0.72|||<|0.001|TWO_SIDED|95.0|-1.05|-0.4||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on CMH-adjusted proportions and corresponding standard errors.|Cochran-Mantel-Haenszel|||For the second dosing interval.||-0.40|-1.05|<0.001
73995061|NCT01266161|147535965|SUPERIORITY||CMH-adjusted proportions|-0.48||||0.002|TWO_SIDED|95.0|-0.9|-0.06||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the third dosing interval.||-0.06|-0.90|0.002
73995062|NCT01266161|147535965|SUPERIORITY||CMH-adjusted proportion|-0.68||||0.021|TWO_SIDED|95.0|-1.02|-0.35||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the fourth dosing interval.||-0.35|-1.02|0.021
73995063|NCT01266161|147535965|SUPERIORITY||CMH-adjusted proportion|-0.7|||<|0.001|TWO_SIDED|95.0|-0.89|-0.51||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the overall study duration.||-0.51|-0.89|<0.001
73995064|NCT01266161|147535968|SUPERIORITY||Gamma statistic|0.85|||<|0.001|TWO_SIDED|95.0|0.74|0.95||p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.|Cochran-Mantel-Haenszel|||Ibuprofen versus placebo at 24 hours||0.95|0.74|<0.001
73995065|NCT01266161|147535968|SUPERIORITY||Gamma statistic|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.92|||Cochran-Mantel-Haenszel|p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.||Ibuprofen versus placebo at 48 hours||0.92|0.66|<0.001
73995066|NCT05239598|147536026|SUPERIORITY||Mean Difference (Net)|4.5||||0.287|TWO_SIDED|95.0|-4.0|13.0|||t-test, 2 sided|||||13.0|-4.0|0.287
73995067|NCT05239598|147536027|SUPERIORITY||Mean Difference (Net)|1.7||||0.625|TWO_SIDED|95.0|-5.2|8.6|||t-test, 2 sided|||5 minutes post intervention||8.6|-5.2|0.625
73995068|NCT05239598|147536027|SUPERIORITY||Mean Difference (Net)|2.5||||0.526|TWO_SIDED|95.0|-5.5|10.5|||t-test, 2 sided|||30 minutes post intervention||10.5|-5.5|0.526
73995069|NCT05239598|147536028|SUPERIORITY||Median Difference (Net)|0.04||||0.511|TWO_SIDED|95.0|-4.2|8.1|||Signed Rank|||Povidone-iodine: 5 minutes Post-Intervention||8.1|-4.2|0.511
73995070|NCT05239598|147536028|SUPERIORITY||Median Difference (Net)|5.4||||0.408|TWO_SIDED|95.0|-10.7|18.6|||Signed Rank|||Povidone-iodine: 30 minutes post-intervention||18.6|-10.7|0.408
73995071|NCT05239598|147536028|SUPERIORITY||Median Difference (Net)|-4.9||||0.907|TWO_SIDED|95.0|-15.2|17.5|||Signed Rank|||Povidone-iodine: 60 minutes post-intervention||17.5|-15.2|0.907
73995072|NCT05239598|147536028|SUPERIORITY||Median Difference (Net)|-2.4||||0.008|TWO_SIDED|95.0|-6.5|-0.9|||Signed Rank|||Placebo: 5 minutes post intervention||-0.9|-6.5|0.008
73995073|NCT05239598|147536028|SUPERIORITY||Median Difference (Net)|-6.6||||0.08|TWO_SIDED|95.0|-10.1|-2.2|||Signed Rank|||Placebo: 30 minutes post-intervention||-2.2|-10.1|0.080
73995074|NCT05239598|147536028|SUPERIORITY||Median Difference (Net)|-8.6||||0.001|TWO_SIDED|95.0|-22.3|-3.9|||Signed Rank|||Placebo: 60 minutes post-intervention||-3.9|-22.3|0.001
73995075|NCT05239598|147536029|SUPERIORITY||Median Difference (Net)|3.1||||0.212|TWO_SIDED|95.0|-2.2|5.8|||Signed Rank|||Povidone-iodine 5 minutes post-intervention||5.8|-2.2|0.212
73995076|NCT05239598|147536029|SUPERIORITY||Median Difference (Net)|1.8||||0.334|TWO_SIDED|95.0|-2.3|6.9|||Signed Rank|||Povidone-iodine 30 minutes post-intervention||6.9|-2.3|0.334
73995077|NCT05239598|147536029|SUPERIORITY||Median Difference (Net)|1.5||||0.269|TWO_SIDED|95.0|-3.1|6.8|||Signed Rank|||Povidone-iodine 60 minutes post-intervention||6.8|-3.1|0.269
73995078|NCT05239598|147536029|SUPERIORITY||Median Difference (Net)|-4.1||||0.026|TWO_SIDED|95.0|-7.1|-0.7|||Signed Rank|||Placebo 5 minutes post-intervention||-0.7|-7.1|0.026
73995079|NCT05239598|147536029|SUPERIORITY||Median Difference (Net)|-0.7||||0.182|TWO_SIDED|95.0|-9.4|2.0|||Signed Rank|||Placebo 30 minutes post-intervention||2.0|-9.4|0.182
73995080|NCT05239598|147536029|SUPERIORITY||Median Difference (Net)|-3.6||||0.353|TWO_SIDED|95.0|-7.7|4.0|||Signed Rank|||Placebo 60 minutes post-intervention||4.0|-7.7|0.353
73995081|NCT02614183|147536039|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.48|-1.37|||Mixed Models Analysis|||||-1.37|-2.48|<.001
73995082|NCT02614183|147536039|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.31|-1.2|||Mixed Models Analysis|||||-1.20|-2.31|<.001
73995083|NCT02614183|147536040|SUPERIORITY||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|2.05|3.37||||||Reduction from Baseline ≥50%||3.37|2.05|
73995084|NCT02614183|147536040|SUPERIORITY||Odds Ratio (OR)|2.48|||||TWO_SIDED|95.0|1.94|3.18||||||Reduction from Baseline ≥50%||3.18|1.94|
73995085|NCT02614183|147536040|SUPERIORITY||Odds Ratio (OR)|2.65|||||TWO_SIDED|95.0|2.04|3.45||||||Reduction from Baseline ≥75%||3.45|2.04|
73995086|NCT02614183|147536040|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|2.01|3.41||||||Reduction from Baseline ≥75%||3.41|2.01|
73995087|NCT02614183|147536040|SUPERIORITY||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|1.96|4.01||||||Reduction from Baseline = 100%||4.01|1.96|
73995088|NCT02614183|147536040|SUPERIORITY||Odds Ratio (OR)|2.61|||||TWO_SIDED|95.0|1.81|3.75||||||Reduction from Baseline = 100%||3.75|1.81|
73995089|NCT02614183|147536041|SUPERIORITY||Mean Difference (Final Values)|7.74|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|5.2|10.28|||Mixed Models Analysis|||||10.28|5.20|<.001
73995090|NCT02614183|147536041|SUPERIORITY||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|1.31|<|0.001|TWO_SIDED|95.0|4.83|9.97|||Mixed Models Analysis|||||9.97|4.83|<.001
73995091|NCT02614183|147536042|SUPERIORITY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.28|-1.33|||Mixed Models Analysis|||||-1.33|-2.28|<.001
73995092|NCT02614183|147536042|SUPERIORITY||Odds Ratio (OR)|-1.61|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.09|-1.14|||Mixed Models Analysis|||||-1.14|-2.09|<.001
73995093|NCT02614183|147536043|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.12|||Mixed Models Analysis|||||-0.12|-0.52|<.001
73995094|NCT02614183|147536043|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.48|-0.07|||Mixed Models Analysis|||||-0.07|-0.48|<.001
73995095|NCT02614183|147536044|SUPERIORITY||Mean Difference (Final Values)|-13.98|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|-18.99|-8.97|||Mixed Models Analysis|||||-8.97|-18.99|<.001
73995096|NCT02614183|147536044|SUPERIORITY||Mean Difference (Final Values)|-13.64|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-18.68|-8.6|||Mixed Models Analysis|||||-8.60|-18.68|<.001
73995097|NCT02614183|147536045|SUPERIORITY||Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|1.61|<|0.001|TWO_SIDED|95.0|-9.45|-3.13|||Mixed Models Analysis|||||-3.13|-9.45|<.001
73995098|NCT02614183|147536045|SUPERIORITY||Mean Difference (Final Values)|-5.19|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-8.39|-1.98|||Mixed Models Analysis|||||-1.98|-8.39|<.001
73995099|NCT02614183|147536046|SUPERIORITY||||||<|0.16|||||||Fisher Exact|||TE ADA Positive.||||<.160
73995100|NCT02614183|147536046|SUPERIORITY|||||||0.02|||||||Fisher Exact|||TE ADA Positive.||||.020
73995101|NCT02614183|147536046|SUPERIORITY|||||||0.131|||||||Fisher Exact|||Neutralizing Antibodies.||||.131
73995102|NCT02614183|147536046|SUPERIORITY|||||||0.009|||||||Fisher Exact|||Neutralizing Antibodies.||||.009
73995103|NCT04991753|147536049|SUPERIORITY||Least square mean difference|-0.45|||=|0.224|TWO_SIDED|95.0|-1.17|0.28|||ANCOVA|||||0.28|-1.17|=0.224
73995104|NCT03299049|147536061|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the two-sided 95% confidence interval (CI) for the Cochran-Mantel Haenzel (CMH) adjusted treatment difference (Q8W minus Q4W) is less than 4%.|Adjusted difference|0.8|||||TWO_SIDED|95.0|-0.6|2.2|||||Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 \>=50 c/mL between each treatment group (Q8W - Q4W) and corresponding 95% CI is presented.|||2.2|-0.6|
73995105|NCT03299049|147536062|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the two-sided 95% CI for the CMH adjusted treatment difference (Q8W minus Q4W) is greater than -10%|Adjusted difference|0.8|||||TWO_SIDED|95.0|-2.1|3.7|||||Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 \<50 c/mL between each treatment group (Q8W-Q4W) and corresponding 95% CI is presented.|||3.7|-2.1|
73995106|NCT01901419|147536109|SUPERIORITY|||||||0.618|||||||t-test, 2 sided|||||||0.618
73995107|NCT01901419|147536110|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.410
73995108|NCT01901419|147536111|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
73995109|NCT01901419|147536112|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
73995110|NCT01901419|147536113|SUPERIORITY|||||||0.512|||||||t-test, 2 sided|||||||0.512
73995111|NCT01901419|147536114|SUPERIORITY|||||||0.144|||||||t-test, 2 sided|||||||0.144
73995112|NCT01901419|147536115|SUPERIORITY|||||||0.338|||||||t-test, 2 sided|||||||0.338
73995113|NCT01901419|147536116|SUPERIORITY|||||||0.356|||||||t-test, 2 sided|||||||0.356
73995114|NCT01901419|147536117|SUPERIORITY|||||||0.478|||||||t-test, 2 sided|||||||0.478
73995115|NCT01901419|147536118|SUPERIORITY|||||||0.515|||||||t-test, 2 sided|||||||0.515
73995116|NCT01901419|147536119|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73995117|NCT01901419|147536120|SUPERIORITY|||||||0.227|||||||t-test, 2 sided|||||||0.227
73995118|NCT01901419|147536121|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
73995119|NCT01901419|147536122|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
73995120|NCT01901419|147536123|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.800
73995121|NCT01901419|147536124|SUPERIORITY|||||||0.948|||||||t-test, 2 sided|||||||0.948
73995122|NCT01901419|147536125|SUPERIORITY|||||||0.682|||||||t-test, 2 sided|||||||0.682
73995123|NCT01901419|147536126|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||||||0.928
73995124|NCT01901419|147536127|SUPERIORITY|||||||0.672|||||||t-test, 2 sided|||||||0.672
73995125|NCT01901419|147536128|SUPERIORITY|||||||0.894|||||||t-test, 2 sided|||||||0.894
73995126|NCT01901419|147536129|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||||||0.135
73995127|NCT01901419|147536130|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||||||0.038
73995128|NCT01901419|147536131|SUPERIORITY|||||||0.852|||||||t-test, 2 sided|||||||0.852
73995129|NCT01901419|147536132|SUPERIORITY|||||||0.454|||||||t-test, 2 sided|||||||0.454
73995130|NCT01901419|147536133|SUPERIORITY|||||||0.663|||||||t-test, 2 sided|||||||0.663
73995131|NCT01901419|147536134|SUPERIORITY|||||||0.872|||||||t-test, 2 sided|||||||0.872
73995132|NCT01901419|147536135|SUPERIORITY|||||||0.318|||||||t-test, 2 sided|||||||0.318
73995133|NCT01901419|147536136|SUPERIORITY|||||||0.365|||||||t-test, 2 sided|||||||0.365
73995134|NCT01901419|147536137|SUPERIORITY|||||||0.077|||||||t-test, 2 sided|||||||0.077
73995135|NCT01901419|147536138|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.640
73995136|NCT02412735|147536143|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2072.|||
73995137|NCT02412735|147536143|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.6427.|||
73995138|NCT02412735|147536144|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2754.|||
73995139|NCT02412735|147536144|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.9087.|||
73995140|NCT02412735|147536145|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2835.|||
73995141|NCT02412735|147536145|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.4739.|||
73995142|NCT02412735|147536146|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2650.|||
73995143|NCT02412735|147536146|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.7004.|||
73995144|NCT02412735|147536147|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.1945.|||
73995145|NCT02412735|147536147|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.8093.|||
73995146|NCT02412735|147536148|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.7842|TWO_SIDED|95.0|0.5|2.46|||Regression, Cox|P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|Hazard ratio and 95% confidence interval (CI) were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|||2.46|0.50|0.7842
73995147|NCT02412735|147536148|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.8754|TWO_SIDED|95.0|0.41|2.14|||Regression, Cox|P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|Hazard ratio and 95% CI were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|||2.14|0.41|0.8754
73995148|NCT02412735|147536149|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2309.|||
73995149|NCT02412735|147536149|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.1241.|||
73995150|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|3.08||0.9072|TWO_SIDED|95.0|-5.71|6.43|||Mixed Model for Repeated Measures (MMRM)|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 1||6.43|-5.71|0.9072
73995151|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|3.14||0.2883|TWO_SIDED|95.0|-9.51|2.83|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 1||2.83|-9.51|0.2883
73995152|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|3.23||0.6314|TWO_SIDED|95.0|-7.9|4.8|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 3||4.80|-7.90|0.6314
73995153|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|3.29||0.1366|TWO_SIDED|95.0|-11.37|1.56|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 3||1.56|-11.37|0.1366
73995154|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.34||0.2497|TWO_SIDED|95.0|-10.43|2.72|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 6||2.72|-10.43|0.2497
73995155|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|3.42||0.0666|TWO_SIDED|95.0|-13.0|0.43|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 6||0.43|-13.00|0.0666
73995156|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.4||0.2147|TWO_SIDED|95.0|-10.91|2.46|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 12||2.46|-10.91|0.2147
73995157|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|3.47||0.0162|TWO_SIDED|95.0|-15.19|-1.55|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 12||-1.55|-15.19|0.0162
73995158|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|3.67||0.223|TWO_SIDED|95.0|-11.69|2.74|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 18||2.74|-11.69|0.2230
73995159|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|3.74||0.1152|TWO_SIDED|95.0|-13.27|1.45|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 18||1.45|-13.27|0.1152
73995160|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|3.66||0.4884|TWO_SIDED|95.0|-9.75|4.67|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 24||4.67|-9.75|0.4884
73995161|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|3.74||0.0426|TWO_SIDED|95.0|-14.98|-0.25|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 24||-0.25|-14.98|0.0426
73995162|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.77||0.3056|TWO_SIDED|95.0|-11.27|3.54|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 36||3.54|-11.27|0.3056
73995163|NCT02412735|147536150|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.85||0.1184|TWO_SIDED|95.0|-13.59|1.54|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 36||1.54|-13.59|0.1184
73995164|NCT04624243|147536163|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS change from baseline|LS Mean Difference|-2.8||||0.241|TWO_SIDED|97.5|-8.3|2.6|||ANCOVA|||||2.6|-8.3|0.241
73995165|NCT04624243|147536163|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS change from baseline|LS Mean Difference|-0.7||||0.784|TWO_SIDED|97.5|-6.3|4.9|||ANCOVA|||||4.9|-6.3|0.784
74035933|NCT02175771|147624363|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.0485||0.9966|TWO_SIDED|95.0|-0.095|0.095|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|Mid-strength comparison||0.095|-0.095|0.9966
73995166|NCT04624243|147536165|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline|LS Mean Difference|-1.3||||0.096|TWO_SIDED|97.5|-3.1|0.5|||ANCOVA|||||0.5|-3.1|0.096
73995167|NCT04624243|147536165|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline|LS Mean Difference|-1.4||||0.094|TWO_SIDED|97.5|-3.2|0.5|||ANCOVA|||||0.5|-3.2|0.094
73995168|NCT04624243|147536166|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 CGI-S change from baseline|LS Mean Difference|-0.2||||0.254|TWO_SIDED|97.5|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.254
73995169|NCT04624243|147536166|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 CGI-S change from baseline|LS Mean Difference|0.0||||0.959|TWO_SIDED|97.5|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.959
73995170|NCT04624243|147536170|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-8.5|||<|0.001|TWO_SIDED|97.5|-10.4|-6.5|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-6.5|-10.4|<0.001
73995171|NCT04624243|147536170|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-7.3|||<|0.001|TWO_SIDED|97.5|-9.3|-5.2|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-5.2|-9.3|<0.001
73995172|NCT04624243|147536171|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-6.0|||<|0.001|TWO_SIDED|97.5|-7.4|-4.6|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-4.6|-7.4|<0.001
73995173|NCT04624243|147536171|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|97.5|-7.0|-4.2|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-4.2|-7.0|<0.001
73995174|NCT01294397|147536174|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio of Day 22/Day 1|0.96|||||TWO_SIDED|90.0|0.85|1.08|||||Two one-sided tests|Log-transformed AUC0-168 was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.||1.08|0.85|
73995175|NCT01294397|147536175|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio of Day 22/Day 1|0.92|||||TWO_SIDED|90.0|0.81|1.05|||||Two one-sided tests|Log-transformed Cmax was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.||1.05|0.81|
73995176|NCT01602510|147536214|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.438|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with Treatment Group as covariate|||1.25|0.59|=0.438
73995177|NCT01602510|147536214|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.212|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with Site as covariate|||1.25|0.59|=0.212
74035934|NCT02175771|147624363|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.059|STANDARD_ERROR_OF_MEAN|0.0464||0.2056|TWO_SIDED|95.0|-0.032|0.15|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|High-strength comparison||0.150|-0.032|0.2056
73995178|NCT01602510|147536214|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.724|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.25|0.59|=0.724
73995179|NCT01602510|147536215|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.869|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with Treatment Group as covariate|||1.66|0.55|=0.869
73995180|NCT01602510|147536215|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.061|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with Site as covariate|||1.66|0.55|=0.061
73995181|NCT01602510|147536215|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.505|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.66|0.55|=0.505
73995182|NCT01602510|147536216|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.369|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with Treatment Group as covariate|||1.32|0.48|=0.369
73995183|NCT01602510|147536216|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.955|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with Site as covariate|||1.32|0.48|=0.955
74035935|NCT04096326|147624364|SUPERIORITY||Rate difference|40.6||||0.0096|TWO_SIDED|95.0|23.6|57.6||P-value was based on Cochran-Mantel-Haenszel (CMH) tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||57.6|23.6|0.0096
74035936|NCT04096326|147624364|SUPERIORITY||Rate difference|46.4||||0.0094|TWO_SIDED|95.0|28.0|64.9||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||64.9|28.0|0.0094
73995184|NCT01602510|147536216|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.874|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.32|0.48|=0.874
73995185|NCT01602510|147536217|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.927|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with Treatment Group as covariate|||1.40|0.73|=0.927
73995186|NCT01602510|147536217|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.036|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with Site as covariate|||1.40|0.73|=0.036
73995187|NCT01602510|147536217|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.509|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.40|0.73|=0.509
73995188|NCT01602510|147536218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||=|0.833|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||||0.5|-0.4|=0.833
73995189|NCT01602510|147536219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||=|0.245|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.245
73995190|NCT01602510|147536220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.155|TWO_SIDED|95.0|-3.0|0.5|||ANCOVA|||||0.5|-3.0|=0.155
73995191|NCT01602510|147536221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||=|0.661|TWO_SIDED|95.0|-1.4|2.2|||ANCOVA|||||2.2|-1.4|= 0.661
73995192|NCT01602510|147536222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||=|0.945|TWO_SIDED|95.0|-3.7|3.5|||ANCOVA|||||3.5|-3.7|= 0.945
73995193|NCT01602510|147536223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||=|0.047|TWO_SIDED|95.0|-1.66|-0.01|||ANCOVA|||||-0.01|-1.66|=0.047
74035937|NCT04096326|147624364|SUPERIORITY||Rate difference|52.2||||0.0044|TWO_SIDED|95.0|23.6|80.8||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||80.8|23.6|0.0044
74035938|NCT04096326|147624364|SUPERIORITY||Rate difference|63.3||||0.0026|TWO_SIDED|95.0|35.2|91.5||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||91.5|35.2|0.0026
73995194|NCT03519204|147536224|SUPERIORITY||Responder Rate Difference|84.7|||<|0.0001|TWO_SIDED|95.0|68.2|94.2||P-value was based on 2-sided Fisher's exact test comparing responder rate between treatment group and no-treated control group.|Fisher Exact|||||94.2|68.2|<0.0001
73995195|NCT03519204|147536226|SUPERIORITY||Median Difference|0.558|STANDARD_ERROR_OF_MEAN|0.109492|<|0.0001|TWO_SIDED|95.0|0.3447|0.7739||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.|||0.77390|0.34470|<0.0001
73995196|NCT03519204|147536227|SUPERIORITY||Median Difference|13.04|STANDARD_ERROR_OF_MEAN|2.122|<|0.0001|TWO_SIDED|95.0|8.861|17.18||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.|||17.180|8.861|<0.0001
73995197|NCT00478192|147536231|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||0.028
73995198|NCT00478192|147536231|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||0.019
73995199|NCT00478192|147536231|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||<0.001
73995200|NCT00478192|147536236|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||ANCOVA|||||||0.079
73995201|NCT00402051|147536261|SUPERIORITY_OR_OTHER||6-Month PFS Rate|52.8|||||TWO_SIDED|95.0|40.3|65.3||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).||65.3|40.3|
73995202|NCT00402051|147536261|SUPERIORITY_OR_OTHER||6-Month PFS Rate|39.3|||||TWO_SIDED|95.0|27.8|50.8||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).||50.8|27.8|
73876840|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|2.5||||0.859|TWO_SIDED|95.0|-24.8|29.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.7|-24.8|0.859
73876841|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
73995203|NCT00402051|147536263|SUPERIORITY_OR_OTHER||Best Overall Response Rate (%)|32.3||||||95.0|21.2|45.1||||||Response rates were evaluated separately for each treatment arm||45.1|21.2|
73995204|NCT00402051|147536263|SUPERIORITY_OR_OTHER||Best Overall Response Rate (%)|20.0||||||95.0|11.1|31.8||||||Response rates were evaluated separately for each treatment arm||31.8|11.1|
73995205|NCT02514551|147536266|SUPERIORITY||Hazard Ratio (HR)|0.617|||||TWO_SIDED|95.0|0.447|0.853|||||Unstratified cox proportional hazards model comparing Ramucirumab I4T-MC-JVCZ and I4T-IE-JVBE (NCT01170663)|"This analysis were comparison of PFS for participants treated with ramucirumab 12 mg/kg plus paclitaxel in Study I4T-MC-JVCZ versus placebo plus paclitaxel in I4T-IE-JVBE (NCT01170663) using meta-analysis.~Placebo + 80 mg/m² Paclitaxel in I4T-IE-JVBE Number of participants: 335, Median (95% CI), months: 2.86 (2.79 to 3.02)"||0.853|0.447|
73995206|NCT02514551|147536267|SUPERIORITY||Hazard Ratio (HR)|0.963|||||TWO_SIDED|95.0|0.727|1.274|||||Unstratified cox proportional hazards model.|||1.274|0.727|
73995207|NCT01791972|147536282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|STANDARD_ERROR_OF_MEAN|1.982|<|0.0001|TWO_SIDED|95.0|-20.19|-12.14||Significance level is 0.05.|mixed-effect analysis of covariance|Fixed effects of sequence, trt group, period, and center, within period baseline FEV1 as a covariate, and random effect for patient within sequence.||||-12.14|-20.19|<0.0001
73995208|NCT01791972|147536283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|0.53|0.84||Terms for treatment and period, computed with the generalized estimating equations (GEE) algorithm, which adjusts for potential correlation between measurements on the same patient. Significance level of 0.05.|Regression, Logistic|||||0.84|0.53|<0.0001
73995209|NCT00630734|147536297|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||Threshold of significance was P\<0.05.|ANOVA|||Relative change data were compared between SLCO1B1 diplotype groups using one-way ANOVA (with post-hoc Bonferroni tests).||||0.43
73995210|NCT00630734|147536298|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||||||0.28
73995211|NCT00630734|147536299|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||ANOVA|||||||0.66
73995212|NCT00630734|147536300|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
73995213|NCT00630734|147536301|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||||||0.11
73995214|NCT00630734|147536302|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
73995215|NCT00630734|147536303|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
73995216|NCT00630734|147536304|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
73995217|NCT00630734|147536305|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||||||0.006
73995218|NCT00630734|147536306|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.08
73995219|NCT02755129|147536356|OTHER||||||||||||||||||"To assess the similarity between the Reveal LINQ measures and those from the reference system, correlation coefficients were used.~The correlation coefficient was calculated over windows of 4 seconds and averaged for each exercise. Then, the average correlation coefficient over all patients and exercise was calculated."|||
73995220|NCT05472740|147536440|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
73995221|NCT03238963|147536472|OTHER||Risk Difference (RD)|0.057|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|-0.053|0.192|||Chan and Zhang method|95% confidence interval was calculating using the Chan and Zhang method.|Risk difference of BI 1467335 10 milligram (mg) group minus Placebo group.|||0.192|-0.053|
73995222|NCT01424813|147536477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.128|<|0.0001|TWO_SIDED|95.0|0.57|1.08||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.08|0.57|<0.0001
73995223|NCT01424813|147536478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|STANDARD_ERROR_OF_MEAN|0.198|<|0.0001|TWO_SIDED|95.0|0.68|1.46||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.46|0.68|<0.0001
73995224|NCT01424813|147536493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.164|<|0.0001|TWO_SIDED|95.0|0.41|1.06||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.06|0.41|<0.0001
73995225|NCT01424813|147536494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|0.38|0.99||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||0.99|0.38|<0.0001
73995226|NCT04944290|147536499|EQUIVALENCE|8AM Day 14|Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-0.71|0.51||||||||0.51|-0.71|
73995227|NCT04944290|147536499|EQUIVALENCE|10AM Day 14|Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.86|0.26||||||10AM Day 14||0.26|-0.86|
73995228|NCT04944290|147536499|EQUIVALENCE|8AM Day 42|Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.58|0.58||||||||0.58|-0.58|
73995229|NCT04944290|147536499|EQUIVALENCE|10AM Day 42|Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.7|0.47||||||||0.47|-0.70|
73995230|NCT03838731|147536500|SUPERIORITY||Hazard Ratio (HR)|0.36|||=|0.0083|TWO_SIDED|95.0|0.17|0.77|||Cox Proportional Hazard|||||0.77|0.17|= 0.0083
73995231|NCT03838731|147536501|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.12|0.48|||Cox Hazard Model|||Day 29||0.48|0.12|< 0.0001
73995232|NCT03838731|147536501|SUPERIORITY||Hazard Ratio (HR)|0.45|||=|0.0222||95.0|0.22|0.89|||Cox Hazard Model|||Day 57||0.89|0.22|= 0.0222
73995233|NCT03838731|147536501|SUPERIORITY||Hazard Ratio (HR)|0.27|||=|0.0003||95.0|0.13|0.56|||Cox Hazard Model|||Day 85||0.56|0.13|= 0.0003
73995234|NCT03838731|147536502|SUPERIORITY|Day 8|LS Mean Difference|13.56|STANDARD_ERROR_OF_MEAN|3.59|<|0.001|TWO_SIDED|95.0|6.35|20.77|||MMRM|||||20.77|6.35|<0.001
73995235|NCT03838731|147536502|SUPERIORITY|Day 29|LS Mean Difference|16.21|STANDARD_ERROR_OF_MEAN|4.97|=|0.002|TWO_SIDED|95.0|6.18|26.24|||MMRM|||||26.24|6.18|= 0.002
73995236|NCT03838731|147536502|SUPERIORITY|Day 57|LS Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|4.94|=|0.016|TWO_SIDED|95.0|2.4|22.2|||MMRM|||||22.20|2.40|= 0.016
73995237|NCT03838731|147536502|SUPERIORITY|Day 85|LS Mean Difference|12.54|STANDARD_ERROR_OF_MEAN|4.54|=|0.008|TWO_SIDED|95.0|3.43|21.65|||MMRM|||||21.65|3.43|= 0.008
73995238|NCT03838731|147536503|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.21|0.53|||MMRM|||Day 8||0.53|0.21|< 0.001
73995239|NCT03838731|147536503|SUPERIORITY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.23|0.68|||MMRM|||Day 29||0.68|0.23|<0.001
73995240|NCT03838731|147536503|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|0.13|0.55|||MMRM|||Day 57||0.55|0.13|= 0.002
73995241|NCT03838731|147536503|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|0.15|0.47|||MMRM|||Day 85||0.47|0.15|= 0.002
73995242|NCT03838731|147536504|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.53|=|0.675|TWO_SIDED|95.0|-0.85|1.29|||MMRM|||Day 8||1.29|-0.85|= 0.675
73995243|NCT03838731|147536504|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.51|=|0.182|TWO_SIDED|95.0|-1.7|0.33|||MMRM|||Day 29||0.33|-1.70|= 0.182
73995244|NCT03838731|147536504|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61|=|0.866|TWO_SIDED|95.0|-1.12|1.32|||MMRM|||Day 57||1.32|-1.12|= 0.866
73995245|NCT03838731|147536504|SUPERIORITY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.6|=|0.146|TWO_SIDED|95.0|-2.08|0.32|||MMRM|||Day 85||0.32|-2.08|= 0.146
73995246|NCT03838731|147536505|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.24|=|0.572|TWO_SIDED|95.0|-0.35|0.63|||MMRM|||Day 8||0.63|-0.35|= 0.572
74035939|NCT04096326|147624364|SUPERIORITY||Rate difference|85.7||||0|TWO_SIDED|95.0|64.2|100.0||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||100.0|64.2|0.0000
74035940|NCT00194025|147624370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||<0.001
74035941|NCT00194025|147624371|SUPERIORITY_OR_OTHER|||||||0.585||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.585
73995247|NCT03838731|147536505|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2|=|0.997|TWO_SIDED|95.0|-0.41|0.41|||MMRM|||Day 29||0.41|-0.41|= 0.997
73995248|NCT03838731|147536505|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.21|=|0.756|TWO_SIDED|95.0|-0.36|0.49|||MMRM|||Day 57||0.49|-0.36|= 0.756
73995249|NCT03838731|147536505|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.15|=|0.333|TWO_SIDED|95.0|-0.46|0.16|||MMRM|||Day 85||0.16|-0.46|= 0.333
73995250|NCT03838731|147536506|SUPERIORITY||LS Mean Difference|39.5|STANDARD_ERROR_OF_MEAN|12.5|=|0.003|TWO_SIDED|95.0|14.36|64.65|||MMRM|||Day 8||64.65|14.36|= 0.003
74035942|NCT00194025|147624372|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||<0.001
74035943|NCT00194025|147624373|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.017
74035944|NCT00194025|147624374|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.027
74035945|NCT00194025|147624375|SUPERIORITY_OR_OTHER|||||||0.569||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.569
73995251|NCT03838731|147536506|SUPERIORITY||LS Mean Difference|54.07|STANDARD_ERROR_OF_MEAN|11.97|<|0.001|TWO_SIDED|95.0|30.01|78.12|||MMRM|||Day 29||78.12|30.01|< 0.001
73995252|NCT03838731|147536506|SUPERIORITY||LS Mean Difference|33.44|STANDARD_ERROR_OF_MEAN|14.28|=|0.023|TWO_SIDED|95.0|4.79|62.08|||MMRM|||Day 57||62.08|4.79|= 0.023
73995253|NCT03838731|147536506|SUPERIORITY||LS Mean Difference|41.1|STANDARD_ERROR_OF_MEAN|12.92|=|0.003|TWO_SIDED|95.0|15.1|67.09|||MMRM|||Day 85||67.09|15.10|= 0.003
73995254|NCT03838731|147536507|SUPERIORITY||LS Mean Difference|205.43|STANDARD_ERROR_OF_MEAN|102.09|=|0.049|TWO_SIDED|95.0|0.69|410.17|||MMRM|||Day 8||410.17|0.69|= 0.049
73995255|NCT03838731|147536507|SUPERIORITY||LS Mean Difference|244.6|STANDARD_ERROR_OF_MEAN|99.05|=|0.017|TWO_SIDED|95.0|45.6|443.59|||MMRM|||Day 29||443.59|45.60|= 0.017
73995256|NCT03838731|147536507|SUPERIORITY||LS Mean Difference|183.03|STANDARD_ERROR_OF_MEAN|96.91|=|0.064|TWO_SIDED|95.0|-11.29|377.35|||MMRM|||Day 57||377.35|-11.29|= 0.064
73995257|NCT03838731|147536507|SUPERIORITY||LS Mean Difference|241.01|STANDARD_ERROR_OF_MEAN|114.0|=|0.039|TWO_SIDED|95.0|12.44|469.57|||MMRM|||Day 85||469.57|12.44|= 0.039
73995258|NCT01088984|147536512|SUPERIORITY_OR_OTHER|||||||1||||||1-sided p-value is calculated against the null hypothesis of a response rate of 5%.|binomial parameter exact method|||||||1.0000
73995259|NCT01006980|147536551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.26|0.55|||Log Rank||The hazard ratio for death for vemurafenib relative to dacarbazine and the associated 95% confidence interval were computed using an unstratified Cox regression model.|The trial had a power of 80% to detect a hazard ratio of 0.65 for overall survival with an alpha level of 0.045 (an increase in median survival from 8 months for dacarbazine to 12.3 months for vemurafenib), one interim analysis for overall survival at 50% information.||0.55|0.26|<0.0001
73995260|NCT01006980|147536552|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.2|0.33|||Log Rank||Hazard ratios for treatment with vemurafenib, as compared with dacarbazine, were estimated with the use of unstratified Cox regression.|The trial had a power of 90% to detect a hazard ratio of 0.55 for progression-free survival with an alpha level of 0.005 (an increase in median survival from 2.5 months for dacarbazine to 4.5 months for vemurafenib).||0.33|0.20|<.0001
73995261|NCT01182441|147536602|SUPERIORITY|Success for this endpoint was achieved if the probability of experiencing an event was statistically less than the performance goal, defined as 2.67%, with an upper bound of the one-sided 95% credible interval less than the performance goal.|probability of experiencing an event|2.2|||||ONE_SIDED|95.0||2.652||||||Bayesian calculations were used to incorporate the data from PROTECT AF CAP Registry through a conjugate beta-binomial model. A one-sided upper 95% credible interval for the event rate was calculated based off this posterior distribution.||2.652||
73995262|NCT01182441|147536603|NON_INFERIORITY|This endpoint is met if the 95% Credible Interval for the rate ratio of WATCHMAN versus Warfarin is entirely less than 1.75.|Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.57|1.89||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval model were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately by treatment group and event type. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||1.89|0.57|
73995263|NCT01182441|147536604|NON_INFERIORITY|This endpoint is met if either the 95% Credible Interval for the risk ratio \< 2.0 or the 95% Credible Interval for the risk difference is \< 0.0275.|Risk Difference (RD)|0.0053|||||TWO_SIDED|95.0|-0.019|0.0273||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||0.0273|-0.0190|
73995264|NCT01182441|147536604|NON_INFERIORITY|This endpoint is met if either the 95% Credible Interval for the risk ratio \< 2.0 or the 95% Credible Interval for the risk difference is \< 0.0275.|Risk Ratio (RR)|1.6|||||TWO_SIDED|95.0|0.5|4.2||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||4.2|0.5|
73995265|NCT00186017|147536692|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
73995266|NCT00186017|147536693|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon (Mann-Whitney)|||||||>.1
73995267|NCT00186017|147536694|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon (Mann-Whitney)|||||||>.1
74035946|NCT00194025|147624376|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.038
74035947|NCT00194025|147624377|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.199
74035948|NCT00194025|147624378|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||The t-test was applied to the values at baseline vs. the values at 12 weeks.||||0.21
74035949|NCT05373706|147624383|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.95||||0.68|TWO_SIDED|95.0|0.76|1.2|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.20|0.76|0.68
74039736|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0002|TWO_SIDED|95.0|1.33|2.51|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.51|1.33|0.0002
73995268|NCT03596762|147536722|SUPERIORITY||Difference in LS means|-1.52|||=|0.1946|TWO_SIDED|95.0|-3.83|0.78|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.78|-3.83|= 0.1946
73995269|NCT03596762|147536722|SUPERIORITY||Difference in LS means|1.29|||=|0.3682|TWO_SIDED|95.0|-4.11|1.53|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||1.53|-4.11|= 0.3682
73995270|NCT03596762|147536722|SUPERIORITY||Difference in LS means|-3.93|||=|0.0002|TWO_SIDED|95.0|-5.94|-1.92|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||-1.92|-5.94|= 0.0002
73995271|NCT03596762|147536722|SUPERIORITY||Difference in LS means|-2.63|||=|0.0115|TWO_SIDED|95.0|-4.66|-0.6|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||-0.6|-4.66|= 0.0115
73995272|NCT03596762|147536723|SUPERIORITY||Difference in LS means|-1.67|||=|0.2097|TWO_SIDED|95.0|-4.28|-0.95|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||-0.95|-4.28|= 0.2097
73995273|NCT03596762|147536723|SUPERIORITY||Difference in LS means|-0.77|||=|0.6369|TWO_SIDED|95.0|-3.97|2.44|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||2.44|-3.97|= 0.6369
73995274|NCT03596762|147536723|SUPERIORITY||Difference in LS means|-2.95|||=|0.0116|TWO_SIDED|95.0|-5.22|-0.67|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||-0.67|-5.22|= 0.0116
73995275|NCT03596762|147536723|SUPERIORITY||Difference in LS means|-1.78|||=|0.1346|TWO_SIDED|95.0|-4.12|0.56|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.56|-4.12|= 0.1346
73995276|NCT03596762|147536724|SUPERIORITY||Difference in LS means|-0.05|||=|0.7033|TWO_SIDED|95.0|-0.3|0.2|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.2|-0.3|= 0.7033
73995277|NCT03596762|147536724|SUPERIORITY||Difference in LS means|-0.14|||=|0.3724|TWO_SIDED|95.0|-0.45|0.17|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.17|-0.45|= 0.3724
73995278|NCT03596762|147536724|SUPERIORITY||Difference in LS means|-0.19|||=|0.0896|TWO_SIDED|95.0|-0.41|0.03|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.03|-0.41|= 0.0896
73995279|NCT03596762|147536724|SUPERIORITY||Difference in LS means|-0.19|||=|0.09|TWO_SIDED|95.0|-0.41|0.03|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.03|-0.41|= 0.09
73995280|NCT03596762|147536725|SUPERIORITY||Difference in LS means|-0.09|||=|0.5511|TWO_SIDED|95.0|-0.39|0.21|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.21|-0.39|= 0.5511
73995281|NCT03596762|147536725|SUPERIORITY||Difference in LS means|0.16|||=|0.3822|TWO_SIDED|95.0|-0.2|0.52|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.52|-0.2|= 0.3822
73995282|NCT03596762|147536725|SUPERIORITY||Difference in LS means|-0.15|||=|0.2606|TWO_SIDED|95.0|-0.41|0.11|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.11|-0.41|= 0.2606
73995283|NCT03596762|147536725|SUPERIORITY||Difference in LS means|-0.27|||=|0.0479|TWO_SIDED|95.0|-0.53|0.0|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0|-0.53|= 0.0479
73995284|NCT00504777|147536868|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73995285|NCT00504777|147536871|SUPERIORITY_OR_OTHER|||||||0.0054|||||||t-test, 2 sided|||||||0.0054
73995286|NCT01572740|147536872|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.3|||<|0.0001||95.0|-1.47|-1.13|||ANCOVA|||||-1.13|-1.47|<0.0001
73995287|NCT01572740|147536873|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.81|||<|0.0001||95.0|-0.99|-0.63|||ANCOVA|||||-0.63|-0.99|<0.0001
73995288|NCT01572740|147536874|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.83|||<|0.0006||95.0|-1.3|-0.36|||ANCOVA|||||-0.36|-1.30|<0.0006
73995289|NCT01572740|147536875|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.26||||0.2511||95.0|-0.7|0.18|||ANCOVA|||||0.18|-0.70|0.2511
73995290|NCT01572740|147536876|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.87|||<|0.0001||95.0|-2.37|-1.38|||ANCOVA|||||-1.38|-2.37|<0.0001
73995291|NCT01572740|147536877|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.28|||<|0.0001||95.0|-1.73|-0.83|||ANCOVA|||||-0.83|-1.73|<0.0001
73995292|NCT01572740|147536878|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.73||||0.0023||95.0|-1.2|-0.26|||ANCOVA|||||-0.26|-1.20|0.0023
73995293|NCT01572740|147536879|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.39||||0.1787||95.0|-0.97|0.18|||ANCOVA|||||0.18|-0.97|0.1787
73995294|NCT01572740|147536880|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.14||||0.4806||95.0|-0.54|0.25|||ANCOVA|||||0.25|-0.54|0.4806
73995295|NCT01572740|147536881|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.35||||0.2074||95.0|-0.91|0.2|||ANCOVA|||||0.20|-0.91|0.2074
73995296|NCT00137969|147536891|SUPERIORITY_OR_OTHER|||||||0.4875||||||One-sided p-value.|Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)||||0.4875
73995297|NCT00137969|147536892|SUPERIORITY_OR_OTHER|||||||0.823|||||||Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)||||0.8230
73995298|NCT00137969|147536893|SUPERIORITY_OR_OTHER|||||||0.4318|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.4318
73995299|NCT00137969|147536894|SUPERIORITY_OR_OTHER|||||||0.9069|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.9069
73995300|NCT00137969|147536895|SUPERIORITY_OR_OTHER|||||||0.5602|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.5602
73995301|NCT00137969|147536896|SUPERIORITY_OR_OTHER|||||||0.8979|||||||Log Rank|||Stratified by randomization factors (race and initial prednisone dose)||||0.8979
73995302|NCT00137969|147536897|SUPERIORITY_OR_OTHER|||||||0.1277|||||||ANCOVA|||Stratified by randomization factors (race and initial prednisone dose)||||0.1277
73995303|NCT00137969|147536898|SUPERIORITY_OR_OTHER|||||||0.6202|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.6202
73995304|NCT00477490|147536899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9303|TWO_SIDED|95.0|-0.221|0.242||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||0.242|-0.221|0.9303
73876842|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
73995305|NCT00477490|147536899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.3104|TWO_SIDED|95.0|-0.353|0.112||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||0.112|-0.353|0.3104
73995306|NCT00477490|147536899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277||||0.0207|TWO_SIDED|95.0|-0.511|-0.042||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||-0.042|-0.511|0.0207
73995307|NCT00477490|147536899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.848|-0.378||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||-0.378|-0.848|<0.0001
73995308|NCT00477490|147536900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.017||||0.942|TWO_SIDED|95.0|0.647|1.598||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids||||1.598|0.647|0.9420
73995309|NCT00477490|147536900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.147||||0.5527|TWO_SIDED|95.0|0.729|1.807||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||1.807|0.729|0.5527
74039737|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.0001|TWO_SIDED|95.0|1.48|2.79|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.79|1.48|<.0001
74039738|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5701|TWO_SIDED|95.0|0.8|1.49|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.49|0.80|0.5701
74039739|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.67||||0.0004|TWO_SIDED|95.0|1.26|2.22|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.22|1.26|0.0004
74039740|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.0001|TWO_SIDED|95.0|1.4|2.46|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.46|1.40|<.0001
74039741|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0008|TWO_SIDED|95.0|1.35|3.17|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.17|1.35|0.0008
74039742|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0059|TWO_SIDED|95.0|1.19|2.83|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.83|1.19|0.0059
74039743|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7741|TWO_SIDED|95.0|0.6|1.46|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.46|0.60|0.7741
74039744|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.5|3.25|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.25|1.50|<.0001
74039745|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0008|TWO_SIDED|95.0|1.32|2.9|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.90|1.32|0.0008
74039746|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.25||||0.089|TWO_SIDED|95.0|0.97|1.6|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.97|0.0890
74039747|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0067|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.83|1.10|0.0067
74039748|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0072|TWO_SIDED|95.0|1.1|1.85|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.85|1.10|0.0072
74039749|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0004|TWO_SIDED|95.0|1.23|2.06|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.06|1.23|0.0004
74039750|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0013|TWO_SIDED|95.0|1.2|2.15|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.15|1.20|0.0013
73995310|NCT00477490|147536900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.296||||0.2662|TWO_SIDED|95.0|0.821|2.05||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||2.050|0.821|0.2662
73995311|NCT00477490|147536900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.893|||<|0.0001|TWO_SIDED|95.0|1.795|4.715||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||4.715|1.795|<0.0001
73995312|NCT01465763|147536920|SUPERIORITY_OR_OTHER||Percent Difference|10.3||||0.007|TWO_SIDED|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).||16.3|4.3|0.0070
73995313|NCT01465763|147536921|SUPERIORITY_OR_OTHER||Percent Difference|15.7||||0.0005|TWO_SIDED|95.0|8.1|23.4|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.4|8.1|0.0005
73995314|NCT01465763|147536922|SUPERIORITY_OR_OTHER||Percent Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.7|36.5|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||36.5|17.7|<0.0001
73995315|NCT01465763|147536923|SUPERIORITY_OR_OTHER||Percent Difference|5.1||||0.0345|TWO_SIDED|95.0|1.9|8.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.3|1.9|0.0345
73995316|NCT01465763|147536924|SUPERIORITY_OR_OTHER||Percent Difference|10.3||||0.007|TWO_SIDED|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.3|4.3|0.0070
73995317|NCT01465763|147536925|SUPERIORITY_OR_OTHER||Percent Difference|6.0||||0.0601|TWO_SIDED|95.0|1.0|11.1|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||11.1|1.0|0.0601
73995318|NCT01465763|147536926|SUPERIORITY_OR_OTHER||Percent Difference|6.5||||0.0043|TWO_SIDED|95.0|4.3|8.7|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.7|4.3|0.0043
73995319|NCT01465763|147536928|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed-Effects Model|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-0.5|-1.3|<0.0001
73995320|NCT01465763|147536928|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed-Effects Model|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-0.7|-1.5|<0.0001
73995321|NCT01465763|147536928|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.9|-1.1|||Mixed-Effects Model|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-1.1|-1.9|<0.0001
73995322|NCT01465763|147536929|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.5|-1.4|||ANCOVA|||The change from Baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.||-1.4|-2.5|<0.0001
73995323|NCT01646177|147536930|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995324|NCT01646177|147536930|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995325|NCT01646177|147536930|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995326|NCT01646177|147536931|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995327|NCT01646177|147536931|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995328|NCT01646177|147536931|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995329|NCT01646177|147536932|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74035950|NCT05373706|147624383|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.1||||0.56|TWO_SIDED|95.0|0.81|1.49|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.49|0.81|0.56
74035951|NCT05373706|147624384|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.93||||0.68|TWO_SIDED|95.0|0.64|1.33|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.33|0.64|0.68
74035952|NCT05373706|147624384|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.24||||0.3|TWO_SIDED|95.0|0.82|1.88|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.88|0.82|0.30
74035953|NCT05373706|147624385|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.89||||0.36|TWO_SIDED|95.0|0.69|1.15|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.15|0.69|0.36
74035954|NCT05373706|147624385|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.05||||0.73|TWO_SIDED|95.0|0.8|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.80|0.73
74035955|NCT05373706|147624386|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.83||||0.11|TWO_SIDED|95.0|0.66|1.04|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.04|0.66|0.11
73876843|NCT02365649|147294849|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
74035956|NCT05373706|147624386|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|0.88||||0.38|TWO_SIDED|95.0|0.66|1.17|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.17|0.66|0.38
74035957|NCT02402218|147624392|SUPERIORITY|||||||0.11||||||For the primary and secondary outcomes, the proportion of participants with the outcome in each group was compared using a chi-square test.|Chi-squared|||Sample size was based on an estimated HCV treatment initiation rate of 50% in the UC group (based on a 33% rate observed during the interferon era) and 80% in the intervention groups, a significance level of 0.05, a desired ratio of participants in the intervention group compared to UC group of 3 to 2, and power of 80% to detect this difference between groups. The study was not powered to detect differences between the peer and cash groups.||||.11
74035958|NCT02402218|147624393|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||.22
74035959|NCT02402218|147624395|SUPERIORITY|||||||0.33|||||||Chi-squared|||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.||||0.33
74035960|NCT02402218|147624396|SUPERIORITY|||||||0.3||||||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.|Chi-squared|||||||0.30
74035961|NCT00807846|147624402|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.274|TWO_SIDED|90.0|-0.56|2.76|||ANCOVA|||The primary analysis was based on 90% confidence interval (CI) for the difference across treatment groups (celecoxib - naproxen) in mean change from baseline in SBP. Change from Baseline in BP was analyzed using analysis of covariance (ANCOVA) with model terms for treatment with baseline height, baseline weight, baseline age, and baseline SBP as covariates. No formal hypothesis testing was applied to the primary analysis.||2.76|-0.56|0.274
74035962|NCT00807846|147624403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.088||||0.148|TWO_SIDED|95.0|-0.39|2.57|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||2.57|-0.39|0.148
74035963|NCT00807846|147624404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.837||||0.027|TWO_SIDED|95.0|0.21|3.46|||ANCOVA|||"For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in blood pressure was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.~Secondary analyses were conducted using a two-sided test with α=0.05."||3.46|0.21|0.027
74090180|NCT01763918|147733550|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.37|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-38.33|-24.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-24.41|-38.33|<0.001
74090181|NCT01763918|147733550|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.0|STANDARD_ERROR_OF_MEAN|3.5|<|0.001|TWO_SIDED|95.0|-37.91|-24.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-24.09|-37.91|<0.001
73995330|NCT01646177|147536932|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995331|NCT01646177|147536932|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995332|NCT01646177|147536933|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995333|NCT01646177|147536933|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995334|NCT01646177|147536933|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995335|NCT01646177|147536934|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995336|NCT01646177|147536934|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995337|NCT01646177|147536934|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995338|NCT01646177|147536935|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995339|NCT01646177|147536935|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995340|NCT01646177|147536935|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995341|NCT01646177|147536936|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995342|NCT01646177|147536936|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995343|NCT01646177|147536936|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995344|NCT01646177|147536937|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995345|NCT01646177|147536937|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995346|NCT01646177|147536937|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995347|NCT01646177|147536938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995348|NCT01646177|147536938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995349|NCT01646177|147536938|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995350|NCT01646177|147536939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995351|NCT01646177|147536939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995352|NCT01646177|147536939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995353|NCT01646177|147536940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.473|TWO_SIDED||||||ANCOVA|||||||0.473
73995354|NCT01646177|147536940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED||||||ANCOVA|||||||0.015
73995355|NCT01646177|147536940|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
73995356|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.006
73995357|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.045
73995358|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.012
73995359|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
73995360|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
73995361|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
73995362|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
73995363|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
73995364|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
73995365|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
73995366|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
73995367|NCT01646177|147536941|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
73995368|NCT01646177|147536942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
73995369|NCT01646177|147536942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
73995370|NCT01646177|147536942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
73995371|NCT01646177|147536942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||0.031
73995372|NCT01646177|147536942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||<0.001
73995373|NCT01646177|147536942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||<0.001
73995374|NCT01646177|147536943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995375|NCT01646177|147536943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995376|NCT01646177|147536943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73995377|NCT01646177|147536944|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995378|NCT01646177|147536944|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995379|NCT01646177|147536944|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995380|NCT01646177|147536945|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995381|NCT01646177|147536945|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995382|NCT01646177|147536945|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995383|NCT01646177|147536946|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995384|NCT01646177|147536946|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995385|NCT01646177|147536946|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73995386|NCT01711853|147536961|SUPERIORITY_OR_OTHER|||||||0.5186|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR (Glomerular filtration rate), 2: \> median GFR).~Median is calculated based on trial data of treated set"||||0.5186
73995387|NCT01711853|147536961|SUPERIORITY_OR_OTHER|||||||0.9883|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: \> median age).~Median is calculated based on trial data of treated set"||||0.9883
73995388|NCT01711853|147536961|SUPERIORITY_OR_OTHER|||||||0.7853|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.||||0.7853
73995389|NCT01711853|147536962|SUPERIORITY_OR_OTHER|||||||0.4692|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR, 2: \> median GFR).~Median is calculated based on trial data of treated set"||||0.4692
73995390|NCT01711853|147536962|SUPERIORITY_OR_OTHER|||||||0.9734|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: \> median age).~Median is calculated based on trial data of treated set"||||0.9734
73995391|NCT01711853|147536962|SUPERIORITY_OR_OTHER|||||||0.9201|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.||||0.9201
73995392|NCT01621776|147537003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|145.1|STANDARD_DEVIATION|78.04||0.971||95.0|129.73|160.47|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||160.47|129.73|.971
73995393|NCT01621776|147537004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|161.09|STANDARD_DEVIATION|62.67||0.698|TWO_SIDED|95.0|144.91|177.28|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||177.28|144.91|.698
73995394|NCT01621776|147537005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|220.46|STANDARD_DEVIATION|89.97||0.806|TWO_SIDED|95.0|197.22|243.71|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||243.71|197.22|.806
74039751|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.34|2.39|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.39|1.34|<.0001
73995395|NCT02269423|147537014|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
73995396|NCT02269423|147537014|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
73995397|NCT02269423|147537014|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
73995398|NCT02269423|147537014|OTHER|||||||0.161||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.161
73995399|NCT02269423|147537014|OTHER|||||||0.008||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.008
73995400|NCT02269423|147537014|OTHER|||||||0.173||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.173
74035964|NCT00807846|147624405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.207||||0.106|TWO_SIDED|95.0|-2.67|0.26|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||0.26|-2.67|0.106
74035965|NCT00807846|147624406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22||||0.776|TWO_SIDED|95.0|-1.3|1.74|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||1.74|-1.30|0.776
74035966|NCT00807846|147624407|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.179||||0.815|TWO_SIDED|95.0|-1.69|1.33|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline blood pressure as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||1.33|-1.69|0.815
74035967|NCT00807846|147624408|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.033||||0.303|TWO_SIDED|95.0|-2.76|8.82|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.||8.82|-2.76|0.303
74035968|NCT00807846|147624409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.061||||0.392|TWO_SIDED|95.0|-0.202|0.079|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of subjects with at least a 30% improvement in Parent/Guardian's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.||0.079|-0.202|0.392
73995401|NCT02269423|147537015|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
73876844|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|10.0||||0.606|TWO_SIDED|95.0|-23.8|43.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||43.8|-23.8|0.606
73995402|NCT02269423|147537015|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
74035969|NCT00807846|147624410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.402||||0.897|TWO_SIDED|95.0|-6.5|5.69|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.||5.69|-6.50|0.897
74035970|NCT00807846|147624411|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.102||||0.2|TWO_SIDED|95.0|-0.257|0.053|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of participants with at least a 30% improvement in participant's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.||0.053|-0.257|0.200
74035971|NCT02491073|147624436|OTHER||geometric mean ratio|1.05||||1.05|TWO_SIDED|90.0|0.98|1.09|||geometric mean ration||The parameter dispersion type:Geometric coefficient of variation Dispersion Value: FT4: 0.220|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.09|0.98|1.05
74035972|NCT02491073|147624436|OTHER||Geometric Mean Ratio|1.15|||||TWO_SIDED|90.0|1.09|1.22|||Geometric Mean Ratio||parameter dispersion type: Geometric Coefficient of Variation Dispersion Value : FT3: 0.178|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.22|1.09|
74039752|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.51|3.3|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.30|1.51|<.0001
74039753|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|2.53|||<|0.0001|TWO_SIDED|95.0|1.72|3.71|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.71|1.72|<.0001
74039754|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0732|TWO_SIDED|95.0|0.98|1.62|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.62|0.98|0.0732
74039755|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.3||||0.0399|TWO_SIDED|95.0|1.01|1.68|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.68|1.01|0.0399
73876845|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|35.0||||0.034|TWO_SIDED|95.0|5.9|64.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significant at the 0.5 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||64.1|5.9|0.034
73995403|NCT02269423|147537015|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
73995404|NCT02269423|147537015|OTHER|||||||0.102||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.102
73995405|NCT02269423|147537015|OTHER|||||||0.124||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.124
73995406|NCT02269423|147537015|OTHER|||||||0.918||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.918
73995407|NCT00755105|147537022|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||< 0.05
73995408|NCT01281839|147537024|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|43.8|||<|0.001|TWO_SIDED|95.0|34.6|53.0|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.||53.0|34.6|<0.001
73995409|NCT01281839|147537025|SUPERIORITY_OR_OTHER||Difference in proportions of SVR72|43.3|||<|0.001|TWO_SIDED|95.0|34.1|52.5|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR72 between the treatment groups.||52.5|34.1|<0.001
73995410|NCT01281839|147537026|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|44.1|||<|0.001|TWO_SIDED|95.0|34.9|53.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||53.2|34.9|<0.001
73995411|NCT01281839|147537027|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|41.0|||<|0.001|TWO_SIDED|95.0|32.1|49.9|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||49.9|32.1|<0.001
73995412|NCT03168542|147537086|SUPERIORITY|Superiority was concluded if the lower 95% of the confidence limit of the proportion of subjects who require no more than one modification was greater than 50%.|Proportion|0.952|||||TWO_SIDED|95.0|0.756|1.0|||Agresti-Coull confidence interval|Agresti-Coull method was used to estimate the confidence interval of the binomial proportions.||||1.000|0.756|
73995413|NCT00203268|147537097|SUPERIORITY_OR_OTHER|||||||0.3025|||||||clustered survival analysis|||||||.3025
73995414|NCT02819024|147537122|OTHER|||||||0.087|||||||t-test, 2 sided|||||||0.087
73995415|NCT03832595|147537136|EQUIVALENCE|We determined that 1,653 patients provide 80% power to detect a hazard ratio of 0.64, or a 5% absolute risk reduction in intervention arm, assuming a primary end-point rate of 15% in the usual care group at 24 months, 20% loss to follow-up, α = 0.05, and within-practice intra-class correlation of 0.01|Hazard Ratio (HR)|0.96||||0.82|TWO_SIDED|95.0|0.67|1.38|||Mixed Models Analysis|||||1.38|0.67|0.82
73995416|NCT03832595|147537137|EQUIVALENCE|α = 0.05|Slope difference|0.011|||||TWO_SIDED|95.0|-0.008|0.029||||||||0.029|-0.008|
73995417|NCT03832595|147537138|EQUIVALENCE|α = 0.05|Rate ratio|1.21|||||TWO_SIDED|95.0|1.02|1.43||||||||1.43|1.02|
73995418|NCT03832595|147537139|EQUIVALENCE|α = 0.05|Rate ratio|0.8|||||TWO_SIDED|95.0|0.51|1.25||||||||1.25|0.51|
73995419|NCT03832595|147537140|EQUIVALENCE|α = 0.05|Rate ratio|1.18|||||TWO_SIDED|95.0|0.03|53.78||||||||53.78|0.03|
73995420|NCT03832595|147537141|EQUIVALENCE|α = 0.05|Rate ratio|1.12|||||TWO_SIDED|95.0|0.12|9.96||||||||9.96|0.12|
73995421|NCT02304705|147537172|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||.052
73995422|NCT00770029|147537186|SUPERIORITY_OR_OTHER||Difference response rate|0.6|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|0.52|0.68|||Fisher Exact|||The efficacy of the treatment was confirmed if H0 was rejected at a given α of 5%, that means if the two sided p-value was ≤0.05. Power of 90%||0.68|0.52|<0.0001
74039756|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0536|TWO_SIDED|95.0|1.0|1.67|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.67|1.00|0.0536
74039757|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0043|TWO_SIDED|95.0|1.12|1.88|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.88|1.12|0.0043
73995423|NCT05504954|147537197|SUPERIORITY||Odds Ratio (OR)|0.26||||0.15|TWO_SIDED|95.0|0.04|1.59|||Regression, Logistic|||||1.59|0.04|0.15
73995424|NCT05504954|147537199|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1|TWO_SIDED|95.0|0.81|9.89|||Regression, Logistic|||||9.89|0.81|0.10
73995425|NCT05504954|147537200|SUPERIORITY||beta coefficient|5.0||||0.65|TWO_SIDED|95.0|-17.78|27.78|||Regression, Linear|||||27.78|-17.78|0.65
73995426|NCT05504954|147537201|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
73995427|NCT05504954|147537202|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||.70
73995428|NCT05504954|147537203|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73995429|NCT05504954|147537204|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.64
73995430|NCT01757197|147537215|OTHER|Not evaluable.|Other|0.0|||||TWO_SIDED|||||Not evaluable.||||Not evaluable.|Not evaluable.|||
73995431|NCT01174446|147537228|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence will be established if 90% C.I. of ratio is contained completely in the margins of equivalence of 0.8 to 1.25.|Ratio of Geometric Means|1.063|||||TWO_SIDED|90.0|1.03|1.09||||||||1.09|1.03|
73995432|NCT01174446|147537255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779||95.0|||||Paired t-test|||||||0.7790
73995433|NCT01174446|147537255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8999||95.0|||||Paired t-test|||||||0.8999
73995434|NCT01174446|147537256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||Paired t-test|||||||0.0056
73995435|NCT01174446|147537256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413||95.0|||||Paired t-test|||||||0.4130
73995436|NCT01174446|147537257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9059||95.0|||||Paired t-test|||||||0.9059
73995437|NCT01174446|147537257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4098||95.0|||||Paired t-test|||||||0.4098
73995438|NCT01174446|147537258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0189||95.0|||||Paired t-test|||||||0.0189
73995439|NCT01174446|147537258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2974||95.0|||||Paired t-test|||||||0.2974
73995440|NCT01174446|147537259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2009||95.0|||||Paired t-test|||||||0.2009
73995441|NCT01174446|147537259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3552||95.0|||||Paired t-test|||||||0.3552
73995442|NCT01174446|147537260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5143||95.0|||||Paired t-test|||||||0.5143
73995443|NCT01174446|147537260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9223||95.0|||||Paired t-test|||||||0.9223
73995444|NCT01174446|147537261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0162||95.0|||||Paired t-test|||||||0.0162
73995445|NCT01174446|147537261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3176||95.0|||||Paired t-test|||||||0.3176
73995446|NCT01174446|147537262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.821||95.0|||||Paired t-test|||||||0.8210
73995447|NCT01174446|147537262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5565||95.0|||||Paired t-test|||||||0.5565
73995448|NCT01174446|147537263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146||95.0|||||Paired t-test|||||||0.0146
73995449|NCT01174446|147537263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4048||95.0|||||Paired t-test|||||||0.4048
73995450|NCT01174446|147537264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1258||95.0|||||Paired t-test|||||||0.1258
73995451|NCT01174446|147537264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2567||95.0|||||Paired t-test|||||||0.2567
73995452|NCT01174446|147537265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1048||95.0|||||Paired t-test|||||||0.1048
73995453|NCT01174446|147537265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641||95.0|||||Paired t-test|||||||0.6410
73995454|NCT01174446|147537266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0663||95.0|||||Paired t-test|||||||0.0663
73995455|NCT01174446|147537266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.489||95.0|||||Paired t-test|||||||0.4890
73995456|NCT01174446|147537267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0562||95.0|||||Paired t-test|||||||0.0562
73995457|NCT01174446|147537267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3864||95.0|||||Paired t-test|||||||0.3864
73995458|NCT01174446|147537268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5792||95.0|||||Paired t-test|||||||0.5792
73995459|NCT01174446|147537269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4208||95.0|||||Paired t-test|||||||0.4208
73995460|NCT01174446|147537270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Paired t-test|||||||0.5000
73995461|NCT01174446|147537271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0633||95.0|||||Paired t-test|||||||0.0633
73995462|NCT01174446|147537271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9363||95.0|||||Paired t-test|||||||0.9363
73995463|NCT00847626|147537285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.8|-9.5||Tested at 5% significance level.|ANCOVA|||Analysis of covariance model (ANCOVA) using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-9.5|-15.8|<0.001
73995464|NCT00847626|147537285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|||<|0.001|TWO_SIDED|95.0|-16.7|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-10.9|-16.7|<0.001
73995465|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7|||<|0.001|TWO_SIDED|95.0|-16.2|-9.2||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.2|-16.2|<0.001
73995466|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9|||<|0.001|TWO_SIDED|95.0|-13.4|-6.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-6.4|-13.4|<0.001
73995467|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|||<|0.001|TWO_SIDED|95.0|-19.2|-12.1||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.1|-19.2|<0.001
73995468|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.001|TWO_SIDED|95.0|-15.8|-8.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.9|-15.8|<0.001
73995469|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.8|||<|0.001|TWO_SIDED|95.0|-19.3|-12.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.3|-19.3|<0.001
73995470|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-16.5|-9.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.5|-16.5|<0.001
73995471|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|||<|0.001|TWO_SIDED|95.0|-17.5|-10.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.5|-17.5|<0.001
73995472|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||<|0.001|TWO_SIDED|95.0|-20.6|-13.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-13.7|-20.6|<0.001
73995473|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.5|||<|0.001|TWO_SIDED|95.0|-17.0|-9.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.9|-17.0|<0.001
73995474|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|||<|0.001|TWO_SIDED|95.0|-19.7|-12.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.7|-19.7|<0.001
73995475|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-16.3|-9.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.3|-16.3|<0.001
73995476|NCT00847626|147537286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.0|||<|0.001|TWO_SIDED|95.0|-19.4|-12.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.6|-19.4|<0.001
73995477|NCT00847626|147537287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.255|TWO_SIDED|95.0|-13.0|3.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||3.5|-13.0|0.255
73995478|NCT00847626|147537287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.2|||<|0.001|TWO_SIDED|95.0|-25.9|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-10.6|-25.9|<0.001
73995479|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-13.6|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.0|-13.6|< 0.001
73995480|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||<|0.001|TWO_SIDED|95.0|-13.7|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.0|-13.7|<0.001
73995481|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|||<|0.001|TWO_SIDED|95.0|-15.1|-8.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.4|-15.1|<0.001
73995482|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|||<|0.001|TWO_SIDED|95.0|-17.3|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.6|-17.3|<0.001
73995483|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.001|TWO_SIDED|95.0|-17.1|-10.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.3|-17.1|<0.001
73995484|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0|||<|0.001|TWO_SIDED|95.0|-15.4|-8.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.7|-15.4|<0.001
73995485|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-14.2|-7.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.6|-14.2|<0.001
73995486|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|||<|0.001|TWO_SIDED|95.0|-17.6|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.9|-17.6|<0.001
73995487|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||<|0.001|TWO_SIDED|95.0|-15.0|-8.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.3|-15.0|<0.001
73995488|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-20.4|-13.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-13.6|-20.4|<0.001
73995489|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-14.7|-7.8||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.8|-14.7|<0.001
74090182|NCT01763918|147733551|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.57|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-39.28|-23.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-23.87|-39.28|<0.001
73995490|NCT00847626|147537300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-16.2|-9.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.4|-16.2|<0.001
73995491|NCT01128270|147537378|SUPERIORITY_OR_OTHER||Mean of one group (2A)|1.64|STANDARD_DEVIATION|0.4|||TWO_SIDED|95.0|1.31|1.97||||Analysis applies only to Arm 2A. (Period 3)|Only arm 2A is relevant to this variable. There is no intended statistical comparison, but the point estimate for the mean level and 95% confidence interval are provided.|No comparison is relevant. The statistical method is how we obtained the point estimate and confidence interval. No test was intended.||1.97|1.31|
73995492|NCT01128270|147537379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2432.0|STANDARD_DEVIATION|1403.0||0.0017|TWO_SIDED|95.0|1260.0|3606.0|||t-test, 2 sided|||Only relevant to Arm 2B.||3606|1260|0.0017
73995493|NCT01128270|147537380|SUPERIORITY_OR_OTHER||Mean|0.38|STANDARD_DEVIATION|0.17|||TWO_SIDED|95.0|0.24|0.51||||||Only relevant for arm 2B||0.51|0.24|
73995494|NCT03296800|147537382|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|118.66|||||TWO_SIDED|90.0|111.12|126.72|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||126.72|111.12|
73995495|NCT03296800|147537382|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|119.62|||||TWO_SIDED|90.0|94.39|151.59||||||Geometric LS Mean was used as PK parameters|Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|151.59|94.39|
73995496|NCT03296800|147537382|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|106.05|||||TWO_SIDED|90.0|88.81|126.65||||||Geometric LS Mean was used as PK parameters|Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|126.65|88.81|
73995497|NCT03296800|147537385|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|140.98|||||TWO_SIDED|90.0|131.39|151.26|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||151.26|131.39|
73995498|NCT03296800|147537385|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|86.12|||||TWO_SIDED|90.0|70.24|105.59|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||105.59|70.24|
73995499|NCT03296800|147537385|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|97.93|||||TWO_SIDED|90.0|90.26|106.26|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||106.26|90.26|
73995500|NCT02224703|147537426|SUPERIORITY||Treatment Ratio|0.743||||0.0299|TWO_SIDED|95.0|0.568|0.971|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.||0.971|0.568|0.0299
73995501|NCT02224703|147537426|SUPERIORITY||Treatment Ratio|0.702||||0.0095|TWO_SIDED|95.0|0.538|0.916|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.||0.916|0.538|0.0095
73995502|NCT02224703|147537427|SUPERIORITY||Treatment Ratio|0.749||||0.0255|TWO_SIDED|95.0|0.581|0.965|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.||0.965|0.581|0.0255
73995503|NCT02224703|147537427|SUPERIORITY||Treatment Ratio|0.62||||0.0003|TWO_SIDED|95.0|0.481|0.799|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.||0.799|0.481|0.0003
73995504|NCT02224703|147537428|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0069|TWO_SIDED|95.0|1.32|5.7|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-12, and 13-18 years).||||5.70|1.32|0.0069
73995505|NCT02224703|147537428|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0332|TWO_SIDED|95.0|1.06|4.62|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-12, and 13-18 years).||||4.62|1.06|0.0332
73995506|NCT02224703|147537429|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0279|TWO_SIDED|95.0|1.08|3.78|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.|||3.78|1.08|0.0279
73995507|NCT02224703|147537429|SUPERIORITY||Odds Ratio (OR)|2.93||||0.0009|TWO_SIDED|95.0|1.56|5.53|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.|||5.53|1.56|0.0009
73995508|NCT03995316|147537433|SUPERIORITY||Slope|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.003
73995509|NCT03995316|147537434|SUPERIORITY||Slope|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.283|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.283
73995510|NCT03995316|147537435|SUPERIORITY||Slope|-0.51|STANDARD_ERROR_OF_MEAN|0.22||0.019|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.019
73995511|NCT03995316|147537436|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.44||0.44|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.440
73995512|NCT03995316|147537437|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.055|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.055
73995513|NCT03995316|147537438|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.041|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.041
73995514|NCT03617835|147537492|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|93.67|||||TWO_SIDED|90.0|78.48|111.8|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||111.80|78.48|
74039758|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0143|TWO_SIDED|95.0|1.07|1.91|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.91|1.07|0.0143
73995515|NCT03617835|147537492|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|139.95|||||TWO_SIDED|90.0|117.26|167.03|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||167.03|117.26|
73995516|NCT03617835|147537493|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|121.84|||||TWO_SIDED|90.0|102.08|145.41|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||145.41|102.08|
73995517|NCT03617835|147537494|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|99.17|||||TWO_SIDED|90.0|83.77|117.39|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||117.39|83.77|
73995518|NCT03617835|147537494|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|156.2|||||TWO_SIDED|90.0|131.95|184.9|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||184.90|131.95|
73995519|NCT03617835|147537495|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|138.34|||||TWO_SIDED|90.0|116.87|163.77|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||163.77|116.87|
73995520|NCT03617835|147537496|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|93.58|||||TWO_SIDED|90.0|78.11|112.11|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||112.11|78.11|
73995521|NCT03617835|147537496|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|139.73|||||TWO_SIDED|90.0|116.64|167.4|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||167.40|116.64|
73995522|NCT03617835|147537497|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|121.34|||||TWO_SIDED|90.0|101.28|145.37|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||145.37|101.28|
73995523|NCT03197766|147537498|SUPERIORITY||||||<|0.0001||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analysis for the primary endpoint.|ANCOVA|Two subjects in the BMN 111 group discontinued from the study before Week 52. The values for these 2 subjects were imputed for this analysis.||||||< 0.0001
73995524|NCT03197766|147537499|SUPERIORITY||||||<|0.0001||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analyses for the two key secondary endpoints.|ANCOVA|Missing assessments at Week 52 were imputed||||||< 0.0001
73995525|NCT03197766|147537500|SUPERIORITY||||||=|0.506||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analyses for the two key secondary endpoints.|ANCOVA|Missing assessments at Week 52 were imputed||||||= 0.506
74039759|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0007|TWO_SIDED|95.0|1.23|2.16|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.16|1.23|0.0007
74039760|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.67||||0.005|TWO_SIDED|95.0|1.17|2.38|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.38|1.17|0.0050
74039761|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0043|TWO_SIDED|95.0|1.18|2.4|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.40|1.18|0.0043
74090183|NCT01763918|147733551|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-28.24|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-35.61|-20.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-20.88|-35.61|<0.001
73995526|NCT00672737|147537502|SUPERIORITY_OR_OTHER||Slope|0.0025|||<|0.05|TWO_SIDED|95.0|0.0009|0.0041|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level the cold pain threshold will additionally increase by 0.0025 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.||0.0041|0.0009|<0.05
73995527|NCT00672737|147537502|SUPERIORITY_OR_OTHER||Slope|-0.9694||||0.05|TWO_SIDED|95.0|-1.9127|-0.0261|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2 the cold pain threshold will additionally increase by 0.9694 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.||-0.0261|-1.9127|0.05
73995528|NCT00672737|147537503|SUPERIORITY_OR_OTHER||Slope|-0.0001|||<|0.05|TWO_SIDED|95.0|-0.0001|-0.0001|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level, the heat pain threshold will additionally decrease by 0.0001 'C for every 1-mcg/mL increase in the plasma level of remifentanil.||-0.0001|-0.0001|<0.05
73995529|NCT00672737|147537503|SUPERIORITY_OR_OTHER||Slope|-0.0172|||<|0.05|TWO_SIDED|95.0|-0.018|0.0556|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2, the heat pain threshold will additionally increase by 0.0172 'C for every 1-mcg/mL increase in the plasma level of remifentanil.||0.0556|-0.018|<0.05
73995530|NCT00972322|147537506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.34|STANDARD_ERROR_OF_MEAN|8.7||0.083|TWO_SIDED|90.0|-29.87|-0.82|||Least Squares Means Difference||Placebo - MK-8245 on Day 28|||-0.82|-29.87|0.083
73995531|NCT01460225|147537513|EQUIVALENCE|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.003|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 2 hours post meal||||0.003
73995532|NCT01460225|147537513|EQUIVALENCE|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.122|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 4 hours post meal||||0.122
73995533|NCT05140915|147537515|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||.77
73995534|NCT03852719|147537556|OTHER||Difference in percentages|46.0|||<|0.0001|TWO_SIDED|96.0|30.5|61.4||Fisher's exact test was used for comparison of bulevirtide 10 mg versus Delayed Treatment using a significance level of 0.04 at Week 48.|Fisher Exact|||||61.4|30.5|<0.0001
73995535|NCT03852719|147537556|OTHER||Difference in percentages|42.9|||<|0.0001|TWO_SIDED|96.0|27.0|58.5||Fisher's exact test was used for comparison of bulevirtide 2 mg versus Delayed Treatment using a significance level of 0.04 at Week 48.|Fisher Exact|||||58.5|27.0|<0.0001
73995536|NCT03852719|147537557|OTHER||Difference in percentages|7.8||||0.4139|TWO_SIDED|96.0|-8.5|24.3||Fisher's exact test was used for the comparison of bulevirtide 10 mg versus bulevirtide 2 mg using a significance level of 0.04 at Week 48.|Fisher Exact|||||24.3|-8.5|0.4139
73995537|NCT03852719|147537558|OTHER||Difference in percentages|39.3|||<|0.0001|TWO_SIDED|95.0|20.0|55.8||Fisher's exact test was used for comparison of bulevirtide 2 mg versus Delayed treatment using a significance level of 0.05.|Fisher Exact|||||55.8|20.0|<0.0001
74090184|NCT01763918|147733552|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.36|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-29.48|-15.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-15.24|-29.48|<0.001
73995538|NCT03852719|147537558|OTHER||Difference in percentage|44.2|||<|0.0001|TWO_SIDED|95.0|25.8|59.9||Fisher's exact test was used for comparison of bulevirtide 10 mg versus Delayed treatment using a significance level of 0.05.|Fisher Exact|||||59.9|25.8|<0.0001
73995539|NCT03852719|147537559|OTHER||Difference in LS Mean|-4.02||||0.001|TWO_SIDED|95.0|-6.39|-1.65|||ANCOVA|||||-1.65|-6.39|0.0010
73995540|NCT03852719|147537559|OTHER||Difference in LS Mean|-3.93||||0.0009|TWO_SIDED|95.0|-6.23|-1.63|||ANCOVA|||||-1.63|-6.23|0.0009
73995541|NCT03852719|147537560|OTHER||Difference in Least Square (LS) Mean|0.57||||0.5156|TWO_SIDED|95.0|-1.16|2.3|||MMRM|||||2.30|-1.16|0.5156
73995542|NCT03852719|147537561|OTHER||Difference in Least Square (LS) Mean|-1.21||||0.2977|TWO_SIDED|95.0|-3.5|1.08|||MMRM|||||1.08|-3.50|0.2977
73995543|NCT03852719|147537562|SUPERIORITY||LS-Mean of Diffrence|-0.04||||0.9719|TWO_SIDED|95.0|-2.23|2.15||P-value was based on the mixed-effects model for repeated measurements (MMRM) model.|MMRM||Least squares (LS) means, standard errors (SE), 95% CIs and p-values were based on the mixed-effects model for repeated measurements (MMRM) model for change from baseline.|||2.15|-2.23|0.9719
73995544|NCT03852719|147537563|SUPERIORITY|P-value was based on the mixed-effects model for repeated measurements (MMRM) model.|LS-Mean of Difference|2.11||||0.2369|TWO_SIDED|95.0|-1.41|5.63|||MMRM||Least squares (LS) means, standard errors (SE), 95% CIs and p-values were based on the mixed-effects model for repeated measurements (MMRM) model for change from baseline.|||5.63|-1.41|0.2369
73995545|NCT03852719|147537564|SUPERIORITY||Response Rate Difference|7.6||||0.4695|TWO_SIDED|95.0|-9.6|24.4||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented.|||24.4|-9.6|0.4695
73995546|NCT03852719|147537564|SUPERIORITY||Response Rate Difference|-0.4||||1|TWO_SIDED|95.0|-16.3|15.5||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented|||15.5|-16.3|1.0000
74090185|NCT01763918|147733552|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.74|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-24.43|-9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-9.05|-24.43|<0.001
73876846|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|-15.0||||0.532|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||0.6|-30.6|0.532
73995547|NCT03852719|147537565|SUPERIORITY||Response Rate Difference|7.7||||0.4539|TWO_SIDED|95.0|-8.8|24.0||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented|||24.0|-8.8|0.4539
73995548|NCT03852719|147537565|SUPERIORITY||Response Rate Difference|-0.3||||1|TWO_SIDED|95.0|-15.6|15.5||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented.|||15.5|-15.6|1.0000
73995549|NCT03746392|147537567|SUPERIORITY|||||||0.036|||||||Fisher Exact|||||||0.036
73995550|NCT04777864|147537585|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Parent group only||||0.18
73995551|NCT04777864|147537585|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Adolescent group only||||0.91
73995552|NCT04777864|147537586|SUPERIORITY|||||||0.975|||||||Regression, Linear|||Parent: Post-Index Visit||||0.975
73876847|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||21.8|-20.5|1.000
73995553|NCT04777864|147537586|SUPERIORITY|||||||0.854|||||||Regression, Linear|||Adolescent: Post-Index Visit||||0.854
73995554|NCT04777864|147537589|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Post-Index Visit||||0.03
74090186|NCT01763918|147733553|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-19.59|STANDARD_ERROR_OF_MEAN|4.22|<|0.001|TWO_SIDED|95.0|-27.92|-11.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-11.26|-27.92|<0.001
73876848|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|-0.6||||1|TWO_SIDED|95.0|-14.4|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||13.3|-14.4|1.000
73995555|NCT04777864|147537589|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||3 months after initial clinic visit||||0.21
73995556|NCT04777864|147537590|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Baseline||||0.76
73995557|NCT04777864|147537590|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Post-Index Visit||||0.96
73995558|NCT04777864|147537590|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||3 months after initial clinic visit||||0.96
73995559|NCT01647542|147537591|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.27|-0.78||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was \<=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2-sided significance level of 0.05.||-0.78|-1.27|<0.001
73995560|NCT01647542|147537591|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.07|-0.57||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was \<=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2-sided significance level of 0.05.||-0.57|-1.07|<0.001
73995561|NCT01647542|147537592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.001|TWO_SIDED|95.0|2.99|10.72||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.||||10.72|2.99|<0.001
73995562|NCT01647542|147537592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|1.81|6.49||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.||||6.49|1.81|<0.001
73995563|NCT01647542|147537593|SUPERIORITY_OR_OTHER||Least squares mean difference|-35.6|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-44.2|-26.9||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value covariate.||||-26.9|-44.2|<0.001
73995564|NCT01647542|147537593|SUPERIORITY_OR_OTHER||Least Squares mean Difference|-35.7|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-44.3|-27.1||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||||-27.1|-44.3|<0.001
73995565|NCT01647542|147537594|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|29.72||0.846|TWO_SIDED|95.0|-57.9|69.6||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.||||69.6|-57.9|0.846
73995566|NCT01647542|147537594|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-24.9|STANDARD_ERROR_OF_MEAN|30.4||0.427|TWO_SIDED|95.0|-90.1|40.3||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.||||40.3|-90.1|0.427
74035973|NCT02491073|147624437|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|1.01|1.03|||||Parameter dispersion type: geometric coefficient of variation dispersion value 0.024|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.03|1.01|
74039762|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2777|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.48|0.89|0.2777
74039763|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0326|TWO_SIDED|95.0|1.02|1.7|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.70|1.02|0.0326
74039764|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1823|TWO_SIDED|95.0|0.92|1.55|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.55|0.92|0.1823
74039765|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.32||||0.035|TWO_SIDED|95.0|1.02|1.71|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.71|1.02|0.0350
74039766|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0164|TWO_SIDED|95.0|1.07|1.88|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.88|1.07|0.0164
74039767|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0257|TWO_SIDED|95.0|1.04|1.84|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.84|1.04|0.0257
74039768|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.64||||0.007|TWO_SIDED|95.0|1.14|2.35|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.35|1.14|0.0070
74039769|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0085|TWO_SIDED|95.0|1.13|2.32|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|1.13|0.0085
74039770|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.09||||0.4925|TWO_SIDED|95.0|0.85|1.41|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.41|0.85|0.4925
74039771|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1534|TWO_SIDED|95.0|0.93|1.55|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.55|0.93|0.1534
74039772|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1202|TWO_SIDED|95.0|0.95|1.6|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.95|0.1202
74039773|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1222|TWO_SIDED|95.0|0.95|1.6|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.95|0.1222
74039774|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0179|TWO_SIDED|95.0|1.06|1.9|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.90|1.06|0.0179
74039775|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0065|TWO_SIDED|95.0|1.12|1.99|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.99|1.12|0.0065
74039776|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0223|TWO_SIDED|95.0|1.06|2.2|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.06|0.0223
74039777|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0045|TWO_SIDED|95.0|1.17|2.4|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.40|1.17|0.0045
74039778|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9385|TWO_SIDED|95.0|0.77|1.28|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.28|0.77|0.9385
74039779|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1093|TWO_SIDED|95.0|0.95|1.59|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.59|0.95|0.1093
74039780|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.21||||0.1631|TWO_SIDED|95.0|0.93|1.57|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.57|0.93|0.1631
74039781|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0285|TWO_SIDED|95.0|1.03|1.74|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.74|1.03|0.0285
74039782|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0389|TWO_SIDED|95.0|1.02|1.81|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.81|1.02|0.0389
74039783|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.39||||0.024|TWO_SIDED|95.0|1.04|1.86|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|1.04|0.0240
73995567|NCT03086655|147537595|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.9|1.93|||||This is the 'inflation part' of the zero inflated negative binomial model. We used cluster robust standard errors due to the multiple observations over time being nested within participant. Result shows odds of intervention group relative to control.|"We used zero inflated negative binomial regression due to the count variable being overdispersed and containing a large number of 0. The analysis aggregated over multiple time points per participant. It simultaneously tests the odds of having 0 openings and the difference in the rate of openings between the 2 intervention groups. These 2 results are reported separately.~Null hypothesis 1: the odds of having 0 openings is lower in intervention than control group."||1.93|0.90|
73995568|NCT03086655|147537595|SUPERIORITY||incidence rate ratio (IRR)|0.77|||||TWO_SIDED|95.0|0.61|0.98|||||This is the negative binomial part of the model. We used cluster robust standard errors due to the multiple observations being nested within participant. Result shows intervention group had lower rate of openings relative to control.|"We used zero inflated negative binomial regression due to the count variable being overdispersed and containing many 0s. The analysis aggregated over multiple time points per participant. It simultaneously tests the odds of having 0 openings and the difference in the rate of openings between the 2 intervention groups. These 2 results are reported separately.~Null hypothesis 2: the incidence rate ratio for # days with box opening is \>1, i.e. more openings in intervention than control group."||0.98|0.61|
73995569|NCT03086655|147537596|SUPERIORITY|||||||0.08|||||||Chi-squared|overall Wald chi2 (2 d.f.), simultaneously testing if parameters for both 6 mo. by intervention and 12 mo. by intervention are different from 0.||"statistical analyses is a GEE model with logit link function and binomial distribution with odds of undetectable VL as outcome and as predictors: intervention, time and time\*intervention. We hypothesize that over time, the odds of undetectable VL will be higher for the intervention than the control group, which would be reflected in a significant interaction effect time\*intervention.~H0: no significant interaction effect time\*intervention"||||0.08
73995570|NCT03086655|147537597|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|95.0|-0.11|0.43||a priori threshold for statistical significance was p=0.05.|t-test, 2 sided|(equal variances assumed)|Difference = control group - treatment group|||0.43|-0.11|<0.05
74039784|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0063|TWO_SIDED|95.0|1.15|2.34|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.34|1.15|0.0063
74039785|NCT02528253|147632451|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0021|TWO_SIDED|95.0|1.22|2.47|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.47|1.22|0.0021
74039786|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.13||0.0003|TWO_SIDED|95.0|-0.75|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.75|0.0003
74039787|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.85|-0.33|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.33|-0.85|<.0001
74039788|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0615|TWO_SIDED|95.0|-0.47|0.01|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.47|0.0615
74039789|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.0356|TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.50|0.0356
74039790|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.0032|TWO_SIDED|95.0|-0.6|-0.12|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.60|0.0032
74039791|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.88|-0.27|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.27|-0.88|0.0003
74039792|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.08|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.46|-1.08|<.0001
74039793|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.15||0.0844|TWO_SIDED|95.0|-0.54|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.54|0.0844
74090187|NCT01763918|147733553|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.56|STANDARD_ERROR_OF_MEAN|4.97|<|0.001|TWO_SIDED|95.0|-21.38|-1.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-1.74|-21.38|<0.001
74090188|NCT01763918|147733554|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|8.38|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|4.36|12.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||12.40|4.36|<0.001
74090189|NCT01763918|147733554|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.48|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|5.1|13.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||13.85|5.10|<0.001
74090190|NCT01763918|147733555|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.2|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|4.66|13.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||13.74|4.66|<0.001
74090191|NCT01763918|147733555|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.07|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|3.48|1466.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||1466|3.48|<0.001
73995571|NCT03086655|147537598|SUPERIORITY|||||||0.08|||||||Chi-squared|overall Wald chi2 (4 d.f.), simultaneously testing if parameters for all follow-ups by intervention are different from 0.||"statistical analyses is a GEE model with logit link function and binomial distribution with odds of optimal adherence as outcome and as predictors: intervention, time and time\*intervention. We hypothesize that over time, the odds of optimal adherence will be higher for the intervention than the control group, which would be reflected in a significant interaction effect time\*intervention.~H0: no significant interaction effect time\*intervention"||||0.08
73995572|NCT05576662|147537600|OTHER||Pooled treatment coefficient|0.026||||0.903|TWO_SIDED|||||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Nonparametric permutation test||Weighted average of treatment coefficients. A pooled treatment coefficient \< 0 favors nirmatrelvir plus ritonavir; a pooled treatment coefficient \> 0 favors placebo plus ritonavir.|A proportional odds logistic regression model was fit for severity of each core symptom at week 10, adjusting for baseline severity of the corresponding symptom and fit using only those who experienced the symptom at baseline. A test statistic for overall efficacy was calculated as the weighted average of the treatment coefficient in the proportional odds model for each symptom with inverse variance weighting. The p-value was obtained by a nonparametric permutation test.||||0.903
73995573|NCT05576662|147537601|OTHER||Odds Ratio (OR)|1.55||||0.174|TWO_SIDED|95.0|0.82|2.94||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of fatigue score at day 15||2.94|0.82|0.174
73995574|NCT05576662|147537601|OTHER||Odds Ratio (OR)|1.21||||0.548|TWO_SIDED|95.0|0.65|2.25||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of brain fog score at day 15||2.25|0.65|0.548
73995575|NCT05576662|147537601|OTHER||Odds Ratio (OR)|0.62||||0.134|TWO_SIDED|95.0|0.33|1.16||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of dyspnea score at day 15||1.16|0.33|0.134
73995576|NCT05576662|147537601|OTHER||Odds Ratio (OR)|1.45||||0.241|TWO_SIDED|95.0|0.78|2.69||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of body aches score at day 15||2.69|0.78|0.241
73995577|NCT05576662|147537601|OTHER||Odds Ratio (OR)|1.03||||0.922|TWO_SIDED|95.0|0.55|1.92||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of gastrointestinal symptoms score at day 15||1.92|0.55|0.922
73995578|NCT05576662|147537601|OTHER||Odds Ratio (OR)|0.5||||0.032|TWO_SIDED|95.0|0.26|0.94||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of cardiovascular symptoms score at day 15||0.94|0.26|0.032
73995579|NCT05576662|147537602|OTHER||Odds Ratio (OR)|0.55||||0.09|TWO_SIDED|95.0|0.27|1.09||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|||1.09|0.27|0.09
73995580|NCT05576662|147537603|OTHER||Odds Ratio (OR)|0.72||||0.6|TWO_SIDED|95.0|0.21|2.44||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|||2.44|0.21|.60
73995581|NCT05576662|147537604|OTHER||Odds Ratio (OR)|1.62||||0.156|TWO_SIDED|95.0|0.83|3.15||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 5||3.15|0.83|0.156
73995582|NCT05576662|147537604|OTHER||Odds Ratio (OR)|1.99||||0.03|TWO_SIDED|95.0|1.06|3.72||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 10||3.72|1.06|0.03
73995583|NCT05576662|147537604|OTHER||Odds Ratio (OR)|2.42||||0.01|TWO_SIDED|95.0|1.27|4.6||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 15||4.60|1.27|0.01
73995584|NCT05576662|147537605|OTHER||Hazard Ratio (HR)|0.9||||0.744|TWO_SIDED|95.0|0.45|1.77||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - fatigue"||1.77|0.45|0.744
73995585|NCT05576662|147537605|OTHER||Hazard Ratio (HR)|0.67||||0.259|TWO_SIDED|95.0|0.32|1.37||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - brain fog"||1.37|0.32|0.259
73995586|NCT05576662|147537605|OTHER||Hazard Ratio (HR)|1.61||||0.286|TWO_SIDED|95.0|0.65|3.99||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - body aches"||3.99|0.65|0.286
73995587|NCT05576662|147537605|OTHER||Hazard Ratio (HR)|0.92||||0.846|TWO_SIDED|95.0|0.38|2.24||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - cardiovascular symptoms"||2.24|0.38|0.846
73995588|NCT05576662|147537605|OTHER||Hazard Ratio (HR)|1.56||||0.41|TWO_SIDED|95.0|0.51|4.73||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test|A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.||"Analysis of data for Time to relief - shortness of breath"||4.73|0.51|0.410
73995589|NCT05576662|147537605|OTHER||Hazard Ratio (HR)|0.94||||0.88|TWO_SIDED|95.0|0.42|2.11||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - gastrointestinal symptoms"||2.11|0.42|0.880
73995590|NCT05576662|147537606|OTHER||Hazard Ratio (HR)|0.74||||0.33|TWO_SIDED|95.0|0.4|1.38||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|||1.38|0.40|0.33
73995591|NCT05576662|147537607|OTHER||Mean Difference (Net)|0.57||||0.66|TWO_SIDED|95.0|-1.96|3.1||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.10|-1.96|.66
73995592|NCT05576662|147537608|OTHER||Mean Difference (Net)|0.38||||0.79|TWO_SIDED|95.0|-2.4|3.15||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||3.15|-2.40|0.79
73995593|NCT05576662|147537609|OTHER||Mean Difference (Net)|0.6||||0.7|TWO_SIDED|95.0|-2.55|3.75||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||3.75|-2.55|.70
73995594|NCT05576662|147537610|OTHER||Mean Difference (Net)|0.03||||0.98|TWO_SIDED|95.0|-3.21|3.28||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.28|-3.21|.98
73995595|NCT05576662|147537611|OTHER||Mean Difference (Net)|1.73||||0.555|TWO_SIDED|95.0|-4.06|7.53||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of data for change of systolic blood pressure||7.53|-4.06|0.555
73995596|NCT05576662|147537611|OTHER||Mean Difference (Net)|-0.68||||0.764|TWO_SIDED|95.0|-5.15|3.79||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of data for change of diastolic blood pressure||3.79|-5.15|0.764
73995597|NCT05576662|147537612|OTHER||Mean Difference (Net)|-0.51||||0.856|TWO_SIDED|95.0|-6.15|5.12||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||5.12|-6.15|0.856
73995598|NCT05576662|147537613|OTHER||Mean Difference (Net)|-0.41||||0.833|TWO_SIDED|95.0|-4.24|3.42||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.42|-4.24|0.833
73995599|NCT05576662|147537614|OTHER||Mean Difference (Final Values)|0.32||||0.096|TWO_SIDED|95.0|-0.06|0.7||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of day 15 data||0.70|-0.06|0.096
73995600|NCT05576662|147537614|OTHER||Mean Difference (Final Values)|0.22||||0.293|TWO_SIDED|95.0|-0.2|0.64||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||0.64|-0.20|0.293
73995601|NCT05576662|147537614|OTHER||Mean Difference (Final Values)|0.19||||0.396|TWO_SIDED|95.0|-0.25|0.62||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.62|-0.25|0.396
73995602|NCT05576662|147537614|OTHER||Mean Difference (Final Values)|0.37||||0.064|TWO_SIDED|95.0|-0.02|0.77||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||0.77|-0.02|0.064
73995603|NCT05576662|147537615|OTHER||Mean Difference (Final Values)|0.19||||0.444|TWO_SIDED|95.0|-0.3|0.67||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of day 15 data||0.67|-0.30|0.444
73995604|NCT05576662|147537615|OTHER||Mean Difference (Final Values)|-0.25||||0.346|TWO_SIDED|95.0|-0.78|0.28||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||0.28|-0.78|0.346
73995605|NCT05576662|147537615|OTHER||Mean Difference (Final Values)|0.1||||0.738|TWO_SIDED|95.0|-0.48|0.67||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.67|-0.48|0.738
73995606|NCT05576662|147537615|OTHER||Mean Difference (Final Values)|0.17||||0.578|TWO_SIDED|95.0|-0.43|0.76||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||0.76|-0.43|0.578
73995607|NCT05576662|147537616|OTHER||Mean Difference (Final Values)|-0.19||||0.758|TWO_SIDED|95.0|-1.41|1.03||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||1.03|-1.41|0.758
73995608|NCT05576662|147537616|OTHER||Mean Difference (Final Values)|-0.24||||0.693|TWO_SIDED|95.0|-1.46|0.97||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.97|-1.46|0.693
73995609|NCT05576662|147537616|OTHER||Mean Difference (Final Values)|0.37||||0.558|TWO_SIDED|95.0|-0.87|1.61||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||1.61|-0.87|0.558
73995610|NCT05576662|147537617|OTHER||Odds Ratio (OR)|0.55||||0.02|TWO_SIDED|95.0|0.33|0.92||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of fatigue data||0.92|0.33|0.02
73995611|NCT05576662|147537617|OTHER||Odds Ratio (OR)|0.5||||0.01|TWO_SIDED|95.0|0.31|0.82||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of brain fog data||0.82|0.31|0.01
73995612|NCT05576662|147537617|OTHER||Odds Ratio (OR)|1.32||||0.34|TWO_SIDED|95.0|0.74|2.33||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of body aches data||2.33|0.74|0.34
73995613|NCT05576662|147537617|OTHER||Odds Ratio (OR)|1.37||||0.29|TWO_SIDED|95.0|0.76|2.48||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of cardiovascular symptoms data||2.48|0.76|0.29
73995614|NCT05576662|147537617|OTHER||Odds Ratio (OR)|1.32||||0.35|TWO_SIDED|95.0|0.73|2.38||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of shortness of breath data||2.38|0.73|0.35
73995615|NCT05576662|147537617|OTHER||Odds Ratio (OR)|1.4||||0.25|TWO_SIDED|95.0|0.79|2.47||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of gastrointestinal symptoms data||2.47|0.79|0.25
73995616|NCT03008005|147537618|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< 0.05
73995617|NCT03008005|147537619|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||< 0.05
73995618|NCT01040169|147537647|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73995619|NCT01040169|147537648|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73995620|NCT00558792|147537689|SUPERIORITY_OR_OTHER|||||||0.0099||95.0|||||Chi-squared|||||||0.0099
73995621|NCT00558792|147537690|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
73995622|NCT00558792|147537691|SUPERIORITY_OR_OTHER|||||||0.1212||95.0|||||Chi-squared|||||||0.1212
73995623|NCT00558792|147537693|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.0200
73995624|NCT00558792|147537694|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||ANOVA|||||||0.0044
73995625|NCT00558792|147537695|SUPERIORITY_OR_OTHER|||||||0.0371||95.0|||||ANOVA|||||||0.0371
73995626|NCT00558792|147537696|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|14.1||||0.2758|TWO_SIDED|95.0|-11.4|39.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||39.6|-11.4|0.2758
73995627|NCT00558792|147537696|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|12.3||||0.3102|TWO_SIDED|95.0|-11.1|35.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||35.6|-11.1|0.3102
73995628|NCT00558792|147537696|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|1.9||||0.8893|TWO_SIDED|95.0|-24.6|28.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||28.4|-24.6|0.8893
73995629|NCT00558792|147537697|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-1.7||||0.2511|TWO_SIDED|95.0|-4.7|1.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.3|-4.7|0.2511
73995630|NCT00558792|147537697|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|1.3||||0.4985|TWO_SIDED|95.0|-2.6|5.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||5.3|-2.6|0.4985
73995631|NCT00558792|147537697|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-3.1||||0.0693|TWO_SIDED|95.0|-6.5|0.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||0.4|-6.5|0.0693
73995632|NCT00558792|147537698|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|-1.5||||0.9104|TWO_SIDED|95.0|-27.9|24.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||24.8|-27.9|0.9104
73995633|NCT00558792|147537698|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|-12.6||||0.2857|TWO_SIDED|95.0|-35.7|10.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||10.5|-35.7|0.2857
73995634|NCT00558792|147537698|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|11.1||||0.3664|TWO_SIDED|95.0|-13.3|35.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||35.5|-13.3|0.3664
73995635|NCT00558792|147537699|SUPERIORITY_OR_OTHER||Difference in Specifcity between Doses|-3.7||||0.1322|TWO_SIDED|95.0|-8.7|1.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.2|-8.7|0.1322
73995636|NCT00558792|147537699|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-1.3||||0.6381|TWO_SIDED|95.0|-6.9|4.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||4.2|-6.9|0.6381
73995637|NCT00558792|147537699|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-2.4||||0.3217|TWO_SIDED|95.0|-7.2|2.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||2.4|-7.2|0.3217
73995638|NCT00558792|147537700|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|7.6||||0.5843|TWO_SIDED|95.0|-19.6|34.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||34.7|-19.6|0.5843
73995639|NCT00558792|147537700|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|4.6||||0.7197|TWO_SIDED|95.0|-20.5|29.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||29.7|-20.5|0.7197
73995640|NCT00558792|147537700|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|3.0||||0.8292|TWO_SIDED|95.0|-24.1|30.1||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||30.1|-24.1|0.8292
73995641|NCT00558792|147537701|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-4.2||||0.0888|TWO_SIDED|95.0|-9.0|0.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||0.7|-9.0|0.0888
73995642|NCT00558792|147537701|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-0.8||||0.7796|TWO_SIDED|95.0|-6.4|4.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||4.8|-6.4|0.7796
73995643|NCT00558792|147537701|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-3.4||||0.1662|TWO_SIDED|95.0|-8.2|1.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.5|-8.2|0.1662
73995644|NCT04092530|147537761|OTHER||Risk Ratio (RR)|0.82||||0.12|TWO_SIDED|95.0|0.64|1.05|||Mixed Models Analysis|Adjusted for time; clustering by clinical site accounted for with random intercept||Please note that there were only 7 units (community health clinics) analyzed at Level 2 of this multilevel study, but due to the crossover design of the study, they were each observed under both the Control and Intervention conditions. Therefore, the Units Analyzed entered above reflect the 7 clinics under both conditions and should not be summed to 14.||1.05|0.64|0.12
73995645|NCT04092530|147537762|OTHER||Risk Ratio (RR)|0.89||||0.33|TWO_SIDED|95.0|0.7|1.13|||Mixed Models Analysis|Adjusted for time; random intercept for clinical site||||1.13|0.70|0.33
73995646|NCT04092530|147537763|OTHER||Risk Ratio (RR)|1.1||||0.88|TWO_SIDED|95.0|0.33|3.73|||Mixed Models Analysis|Adjusted for time; random intercept for clinical site||||3.73|0.33|0.88
73995647|NCT03317990|147537812|SUPERIORITY||Mean Difference (Final Values)|3.18|||<|0.0001|TWO_SIDED|95.0|1.62|4.75|||Regression, Linear|||Normal linear regression model adjusted for recruitment site, participant's age, and IIEF-5 at baseline, in participants with available data||4.75|1.62|<0.0001
73995648|NCT03317990|147537813|SUPERIORITY||Mean Difference (Final Values)|-1.41||||0.006|TWO_SIDED|95.0|-2.42|-0.41|||Regression, Linear|||||-0.41|-2.42|0.006
73995649|NCT04421950|147537892|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73995650|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference :|-13.5|||||TWO_SIDED|95.0|-18.3|-8.7|||||2-Sided 95% CIs were calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.|Serotype 1||-8.7|-18.3|
73995651|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-17.9|||||TWO_SIDED|95.0|-23.2|-12.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 3||-12.4|-23.2|
73995652|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-11.0|||||TWO_SIDED|95.0|-16.0|-5.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 4||-5.9|-16.0|
73995653|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-12.6|||||TWO_SIDED|95.0|-17.8|-7.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 5||-7.2|-17.8|
73995654|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-14.1|||||TWO_SIDED|95.0|-19.5|-8.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6A||-8.6|-19.5|
73995655|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-15.8|||||TWO_SIDED|95.0|-21.0|-10.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6B||-10.6|-21.0|
73995656|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-2.6|||||TWO_SIDED|95.0|-6.3|1.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 7F||1.1|-6.3|
73995657|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-14.3|||||TWO_SIDED|95.0|-19.7|-8.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 9V||-8.9|-19.7|
73995658|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-3.3|||||TWO_SIDED|95.0|-7.9|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 14||1.4|-7.9|
73995659|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-5.5|||||TWO_SIDED|95.0|-10.6|-0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 18C||-0.4|-10.6|
73995660|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-1.7|||||TWO_SIDED|95.0|-4.8|1.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19A||1.3|-4.8|
73995661|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-1.4|||||TWO_SIDED|95.0|-4.0|1.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19F||1.2|-4.0|
73995662|NCT04546425|147537918|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-18.3|||||TWO_SIDED|95.0|-23.6|-12.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 23F||-12.9|-23.6|
73995663|NCT04546425|147537918|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|59.9|||||TWO_SIDED|95.0|55.6|64.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 8||64.1|55.6|
73995664|NCT04546425|147537918|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|-7.6|||||TWO_SIDED|95.0|-13.1|-2.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 10A||-2.1|-13.1|
73995665|NCT04546425|147537918|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.6|||||TWO_SIDED|95.0|53.1|61.9|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 11A||61.9|53.1|
73995666|NCT04546425|147537918|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|-6.2|||||TWO_SIDED|95.0|-11.7|-0.7|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 12F||-0.7|-11.7|
73995667|NCT04546425|147537918|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.8|||||TWO_SIDED|95.0|53.3|62.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 15B||62.1|53.3|
73995668|NCT04546425|147537918|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.8|||||TWO_SIDED|95.0|53.3|62.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 22F||62.1|53.3|
73995669|NCT04546425|147537918|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|10.3|||||TWO_SIDED|95.0|4.5|16.0|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 33F||16.0|4.5|
73995670|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.61|||||TWO_SIDED|95.0|0.54|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 1||0.69|0.54|
73995671|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.64|0.79|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 3||0.79|0.64|
73995672|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 4||0.69|0.52|
73995673|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.7|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 5||0.70|0.52|
73995674|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.54|||||TWO_SIDED|95.0|0.45|0.65|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6A||0.65|0.45|
73995675|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.51|||||TWO_SIDED|95.0|0.43|0.61|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6B||0.61|0.43|
73995676|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.8|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 7F||0.80|0.64|
73995677|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.59|||||TWO_SIDED|95.0|0.5|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 9V||0.69|0.50|
74035974|NCT02491073|147624437|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|1.03|1.04|||||parameter dispersion value - geometric coefficient of variation dispersion value - 0.020|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.04|1.03|
74035975|NCT02491073|147624437|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.05|||||TWO_SIDED|90.0|1.05|1.06|||||parameter dispersion type - geometric coefficient variation dispersion value - 0.021|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.06|1.05|
74035976|NCT02491073|147624437|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.02|||||parameter dispersion type -geometric coefficient of variation dispersion value - 0.040|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.02|0.99|
74035977|NCT02491073|147624437|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geotmetric mean ratio|1.02|||||TWO_SIDED|90.0|1.0|1.03|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.03|1.00|
73876849|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.0|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||14.6|-16.0|1.000
73995678|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.96|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 14||0.96|0.70|
73995679|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 18C||0.92|0.67|
74035978|NCT02491073|147624437|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.03|||||TWO_SIDED|90.0|1.02|1.04|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.04|1.02|
74035979|NCT02491073|147624438|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
74035980|NCT02491073|147624438|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
74035981|NCT02491073|147624438|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH||1.01|1.00|
73995680|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.59|||||TWO_SIDED|95.0|0.51|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19A||0.69|0.51|
74090192|NCT01763918|147733556|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.63|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-29.46|-15.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-15.81|-29.46|<0.001
74090193|NCT01763918|147733556|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-15.54|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-23.25|-7.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-7.84|-23.25|<0.001
74090194|NCT01763918|147733557|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.97|STANDARD_ERROR_OF_MEAN|4.21|<|0.001|TWO_SIDED|95.0|-29.29|-12.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-12.66|-29.29|<0.001
74090195|NCT01763918|147733557|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-9.17|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|95.0|-19.01|0.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||0.68|-19.01|<0.001
74090196|NCT01553747|147733558|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
74090197|NCT01553747|147733558|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
73995681|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.82|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19F||0.82|0.64|
73995682|NCT04546425|147537919|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.52|||||TWO_SIDED|95.0|0.44|0.62|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 23F||0.62|0.44|
73995683|NCT04546425|147537919|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|26.55|||||TWO_SIDED|95.0|22.98|30.67|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 8||30.67|22.98|
74090198|NCT01553747|147733559|SUPERIORITY|||||||0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.001
74090199|NCT01553747|147733559|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
74090200|NCT01490931|147733592|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P value adjusted with Bonferroni corrections for multiple comparisons|t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
74090201|NCT01490931|147733596|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
73995684|NCT04546425|147537919|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.67|||||TWO_SIDED|95.0|2.25|3.17|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 10A||3.17|2.25|
74090202|NCT01490931|147733597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
74090203|NCT01490931|147733598|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
73995685|NCT04546425|147537919|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|26.6|||||TWO_SIDED|95.0|22.95|30.82|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 11A||30.82|22.95|
74090204|NCT01490931|147733599|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
74090205|NCT01490931|147733600|SUPERIORITY_OR_OTHER||||||<|1|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0001
74090206|NCT01490931|147733601|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
74090207|NCT01490931|147733602|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
73995686|NCT04546425|147537919|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.48|||||TWO_SIDED|95.0|2.08|2.97|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 12F||2.97|2.08|
73995687|NCT04546425|147537919|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|54.6|||||TWO_SIDED|95.0|46.35|64.3|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 15B||64.30|46.35|
73995688|NCT04546425|147537919|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|36.8|||||TWO_SIDED|95.0|31.57|42.89|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 22F||42.89|31.57|
73995689|NCT04546425|147537919|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.03|||||TWO_SIDED|95.0|4.27|5.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 33F||5.92|4.27|
73995690|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.67|||||TWO_SIDED|95.0|0.6|0.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 1||0.75|0.60|
74039794|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.14||0.0258|TWO_SIDED|95.0|-0.6|-0.04|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.60|0.0258
74039795|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|95.0|-0.8|-0.23|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.23|-0.80|0.0004
74039796|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.17||0.0079|TWO_SIDED|95.0|-0.78|-0.12|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.78|0.0079
74039797|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.08|-0.41|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.41|-1.08|<.0001
74039798|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.0977|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.57|0.0977
74039799|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.215|TWO_SIDED|95.0|-0.5|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.50|0.2150
73995691|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.59|0.73|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 3||0.73|0.59|
73995692|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 4||0.87|0.68|
73995693|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 5||0.81|0.64|
73995694|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.57|0.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6A||0.75|0.57|
73995695|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.57|||||TWO_SIDED|95.0|0.48|0.67|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6B||0.67|0.48|
73995696|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.73|||||TWO_SIDED|95.0|0.67|0.8|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 7F||0.80|0.67|
73995697|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.73|||||TWO_SIDED|95.0|0.66|0.81|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 9V||0.81|0.66|
73995698|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.8|||||TWO_SIDED|95.0|0.69|0.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 14||0.92|0.69|
73995699|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.75|||||TWO_SIDED|95.0|0.67|0.84|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 18C||0.84|0.67|
73995700|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.93|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19A||0.93|0.72|
73995701|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19F||0.87|0.68|
73995702|NCT04546425|147537920|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 23F||0.69|0.52|
73995703|NCT04546425|147537920|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.48|||||TWO_SIDED|95.0|1.32|1.66|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 8||1.66|1.32|
73995704|NCT04546425|147537920|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.02|||||TWO_SIDED|95.0|1.77|2.3|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 10A||2.30|1.77|
73876850|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|12.1||||0.35|TWO_SIDED|95.0|-11.7|35.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.8|-11.7|0.350
73995705|NCT04546425|147537920|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.55|||||TWO_SIDED|95.0|1.37|1.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 11A||1.75|1.37|
73995706|NCT04546425|147537920|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 12F||0.87|0.68|
73995707|NCT04546425|147537920|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.42|||||TWO_SIDED|95.0|4.82|6.1|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 15B||6.10|4.82|
73995708|NCT04546425|147537920|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|3.84|||||TWO_SIDED|95.0|3.4|4.34|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 22F||4.34|3.40|
73995709|NCT04546425|147537920|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.64|||||TWO_SIDED|95.0|2.33|2.99|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 33F||2.99|2.33|
73995710|NCT04546425|147537921|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC -13vPnC) was greater than -10%.|Percent difference|-0.2|||||TWO_SIDED|95.0|-1.3|0.8|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Diphtheria||0.8|-1.3|
73995711|NCT04546425|147537921|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|-0.6|||||TWO_SIDED|95.0|-1.8|0.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Tetanus||0.2|-1.8|
73995712|NCT04546425|147537921|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|-2.3|||||TWO_SIDED|95.0|-5.3|0.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|PT||0.7|-5.3|
73995713|NCT04546425|147537921|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.2|||||TWO_SIDED|95.0|-2.6|2.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|FHA||2.9|-2.6|
73995714|NCT04546425|147537921|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|1.6|||||TWO_SIDED|95.0|-0.9|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|PRN||4.2|-0.9|
73995715|NCT04546425|147537921|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|1.1|||||TWO_SIDED|95.0|-1.1|4.0|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Hepatitis B||4.0|-1.1|
73995716|NCT04546425|147537921|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC -13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 1||4.2|-4.6|
73995717|NCT04546425|147537921|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 2||4.2|-4.6|
74039800|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.15||0.0016|TWO_SIDED|95.0|-0.79|-0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.79|0.0016
73876851|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|21.7||||0.034|TWO_SIDED|95.0|2.0|41.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significant at the 0.5 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||41.3|2.0|0.034
73995718|NCT04546425|147537921|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 3||4.2|-4.6|
73995719|NCT04546425|147537921|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.0|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Hib||2.2|-2.0|
73995720|NCT04546425|147537922|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.79|1.42|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Measles||1.42|0.79|
73995721|NCT04546425|147537923|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.76|1.44|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Mumps||1.44|0.76|
73995722|NCT04546425|147537924|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.83|||||TWO_SIDED|95.0|0.63|1.1|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Rubella||1.10|0.63|
73995723|NCT04546425|147537925|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.24|||||TWO_SIDED|95.0|0.98|1.57|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Varicella||1.57|0.98|
73995724|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-1.0|||||TWO_SIDED|95.0|-3.1|0.9|||||2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.|Serotype 1 \\||0.9|-3.1|
73995725|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-10.6|||||TWO_SIDED|95.0|-14.7|-6.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 3||-6.7|-14.7|
73995726|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.4|1.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 4||1.3|-1.4|
73995727|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.4|||||TWO_SIDED|95.0|-1.4|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 5||2.2|-1.4|
73995728|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.6|1.5|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6A||1.5|-1.6|
73995729|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.8|||||TWO_SIDED|95.0|-1.1|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6B||2.7|-1.1|
73995730|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 7F||0.4|-1.5|
73995731|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.4|||||TWO_SIDED|95.0|-1.0|1.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 9V||1.9|-1.0|
73995732|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-1.5|||||TWO_SIDED|95.0|-3.7|0.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 14||0.6|-3.7|
73995733|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|1.0|||||TWO_SIDED|95.0|-0.5|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 18C||2.7|-0.5|
73995734|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19A||1.1|-1.1|
73995735|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.2|||||TWO_SIDED|95.0|-0.9|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19F||1.4|-0.9|
73995736|NCT04546425|147537939|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-0.9|||||TWO_SIDED|95.0|-3.2|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 23F||1.4|-3.2|
73995737|NCT04546425|147537939|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.0|||||TWO_SIDED|95.0|0.4|3.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 8||3.9|0.4|
73995738|NCT04546425|147537939|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.5|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 10A||2.7|-1.5|
73995739|NCT04546425|147537939|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|1.2|||||TWO_SIDED|95.0|-0.7|3.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 11A||3.2|-0.7|
73995740|NCT04546425|147537939|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|-0.6|||||TWO_SIDED|95.0|-2.9|1.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 12F||1.6|-2.9|
73995741|NCT04546425|147537939|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.2|||||TWO_SIDED|95.0|0.7|4.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 15B||4.1|0.7|
73995742|NCT04546425|147537939|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.0|||||TWO_SIDED|95.0|0.4|3.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 22F||3.9|0.4|
73995743|NCT04546425|147537939|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|1.4|||||TWO_SIDED|95.0|-0.4|3.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 33F||3.4|-0.4|
73995744|NCT04546425|147537943|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-4.5|||||TWO_SIDED|95.0|-11.2|2.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Diphtheria||2.1|-11.2|
73995745|NCT04546425|147537943|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-3.0|||||TWO_SIDED|95.0|-7.0|0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Tetanus||0.4|-7.0|
73995746|NCT04546425|147537943|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-0.5|||||TWO_SIDED|95.0|-5.2|4.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|PT||4.1|-5.2|
73995747|NCT04546425|147537943|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-1.5|||||TWO_SIDED|95.0|-6.4|3.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|FHA||3.3|-6.4|
73995748|NCT04546425|147537943|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-1.5|||||TWO_SIDED|95.0|-6.4|3.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|PRN||3.3|-6.4|
73995749|NCT04546425|147537943|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-3.3|||||TWO_SIDED|95.0|-10.0|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 1||2.2|-10.0|
73995750|NCT04546425|147537943|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-2.8|||||TWO_SIDED|95.0|-11.8|5.8|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 2||5.8|-11.8|
73995751|NCT04546425|147537943|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-4.2|||||TWO_SIDED|95.0|-10.2|-0.5|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 3||-0.5|-10.2|
73995752|NCT04546425|147537943|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|0.0|||||TWO_SIDED|95.0|-1.8|2.0|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Hib||2.0|-1.8|
73995753|NCT01725126|147537992|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.38|1.75|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in body weight.||1.75|-1.38|
73995754|NCT01725126|147537992|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.08|||||TWO_SIDED|95.0|-0.2|2.36|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in body weight.||2.36|-0.20|
74090208|NCT01490931|147733603|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
73995755|NCT01725126|147537993|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-1.64|1.87|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 percent change from Baseline in body weight.||1.87|-1.64|
74090209|NCT03407118|147733634|SUPERIORITY||ratio of least square means|0.967|||||TWO_SIDED|95.0|0.803|1.17||||||||1.17|0.803|
74090210|NCT03050918|147733640|SUPERIORITY|||||||0.05||||||we used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||.05
74090211|NCT03050918|147733641|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
74090212|NCT03050918|147733641|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||.05
74090213|NCT03050918|147733642|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
74090214|NCT03050918|147733642|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||.05
74090215|NCT03050918|147733643|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||.05
74090216|NCT03050918|147733644|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||0.05
74090217|NCT03050918|147733645|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
74090218|NCT03050918|147733647|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
73876852|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|1.2||||1|TWO_SIDED|95.0|-15.9|18.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||18.3|-15.9|1.000
73995756|NCT01725126|147537993|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|-0.24|2.75|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 percent change from Baseline in body weight.||2.75|-0.24|
73995757|NCT01725126|147537994|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.182|||||TWO_SIDED|95.0|-1.694|1.331|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.||1.331|-1.694|
73995758|NCT01725126|147537994|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.356|||||TWO_SIDED|95.0|-1.409|0.698|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.||0.698|-1.409|
74090219|NCT03832738|147733651|SUPERIORITY||Odds Ratio (OR)|1.5||||0.558|TWO_SIDED|95.0|0.39|5.8||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||5.80|0.39|0.558
74090220|NCT03832738|147733651|SUPERIORITY||Odds Ratio (OR)|3.74||||0.035|TWO_SIDED|95.0|1.07|13.1||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||13.10|1.07|0.035
74090221|NCT03832738|147733652|SUPERIORITY||Odds Ratio (OR)|2.26||||0.086|TWO_SIDED|95.0|0.89|5.75||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||5.75|0.89|0.086
74090222|NCT03832738|147733652|SUPERIORITY||Odds Ratio (OR)|3.76||||0.006|TWO_SIDED|95.0|1.45|9.75||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||9.75|1.45|0.006
74090223|NCT03832738|147733653|SUPERIORITY||Odds Ratio (OR)|1.0|||>|0.999|TWO_SIDED|95.0|0.06|17.25||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||17.25|0.06|>0.999
74090224|NCT03832738|147733653|SUPERIORITY||Odds Ratio (OR)|3.86||||0.244|TWO_SIDED|95.0|0.36|41.2||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||41.20|0.36|0.244
74090225|NCT03832738|147733655|SUPERIORITY||Odds Ratio (OR)|5.21||||0.009|TWO_SIDED|95.0|1.38|19.62||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||19.62|1.38|0.009
74090226|NCT03832738|147733655|SUPERIORITY||Odds Ratio (OR)|7.35||||0.002|TWO_SIDED|95.0|1.86|29.08||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||29.08|1.86|0.002
74090227|NCT00430950|147733715|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.2648||95.0|-1.51|0.42|||ANCOVA|||"The ANCOVA model included treatment as main effect and baseline mean trough sitting dBP as covariate.~Significance level alpha = 5%. Power = 80%.~The following statistical superiority hypothesis was tested:~Superiority of OM/HCTZ combination therapy 40/25 mg over OM/HCTZ 20/25 mg"||0.42|-1.51|0.2648
74090228|NCT00430950|147733716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.4246||95.0|-1.26|0.53|||ANCOVA|||||0.53|-1.26|0.4246
74090229|NCT00430950|147733717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7019||95.0|-1.84|1.24|||ANCOVA||refers to 8 week change; from week 8 to week 16|||1.24|-1.84|0.7019
74090230|NCT00430950|147733717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7328||95.0|-1.71|1.21|||ANCOVA||refers to 4 week change; from week 8 to week 12|||1.21|-1.71|0.7328
74090231|NCT00430950|147733718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0016||95.0|-2.58|-0.6|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.60|-2.58|0.0016
74090232|NCT00430950|147733718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0031||95.0|-2.61|-0.53|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.53|-2.61|0.0031
73995759|NCT01725126|147537994|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.853|||||TWO_SIDED|95.0|-2.232|0.526|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.||0.526|-2.232|
73995760|NCT01725126|147537994|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-1.219|||||TWO_SIDED|95.0|-2.447|0.009|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.||0.009|-2.447|
73995761|NCT01725126|147537995|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.155|||||TWO_SIDED|95.0|-1.277|1.587|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B -Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in fasting glucose.||1.587|-1.277|
73995762|NCT01725126|147537995|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.524|||||TWO_SIDED|95.0|-1.939|0.892|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in fasting glucose.||0.892|-1.939|
73995763|NCT01725126|147537997|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.065|||||TWO_SIDED|95.0|-0.495|0.365|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in HbA1c.||0.365|-0.495|
73995764|NCT01725126|147537997|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.219|||||TWO_SIDED|95.0|-0.91|0.472|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in HbA1c.||0.472|-0.910|
73995765|NCT01725126|147538001|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.046|||||TWO_SIDED|90.0|0.729|1.5008|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.||1.5008|0.7290|
73995766|NCT01725126|147538002|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.0334|||||TWO_SIDED|90.0|0.781|1.3673|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.||1.3673|0.7810|
74090233|NCT00430950|147733718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0073||95.0|-2.58|-0.4|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.40|-2.58|0.0073
74090234|NCT00430950|147733718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0021||95.0|-3.71|-0.82|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.82|-3.71|0.0021
74090235|NCT00430950|147733718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0031||95.0|-3.76|-0.76|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.76|-3.76|0.0031
74090236|NCT00430950|147733718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.0104||95.0|-3.61|-0.48|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.48|-3.61|0.0104
74090237|NCT00430950|147733719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||||95.0|0.85|1.4|||Regression, Logistic|||||1.40|0.85|
74090238|NCT01564459|147733732|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.587||||0.269|TWO_SIDED|95.0|-1.637|0.464|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction||||0.464|-1.637|0.269
73995767|NCT01725126|147538004|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.675|||||TWO_SIDED|90.0|0.585|0.779|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.||0.779|0.585|
73995768|NCT01725126|147538005|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.662|||||TWO_SIDED|90.0|0.578|0.757|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.||0.757|0.578|
74090239|NCT01564459|147733733|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.687||||0.108|TWO_SIDED|95.0|-1.527|0.154|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction||||0.154|-1.527|0.108
74090240|NCT01138111|147733772|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The baseline neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0001
74090241|NCT01138111|147733772|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The 12 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0011
73995769|NCT03031496|147538057|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|91.52|||||TWO_SIDED|90.0|87.77|95.43|||||Comparison of AUC (0-t) of hydrochlorothiazide for test and reference product has been presented.|||95.43|87.77|
73995770|NCT03031496|147538057|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|102.42|||||TWO_SIDED|90.0|98.12|106.91|||||Comparison of AUC (0-t) of amiloride for test and reference product has been presented.|||106.91|98.12|
73995771|NCT03031496|147538058|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|82.86|||||TWO_SIDED|90.0|77.37|88.74|||||Comparison of Cmax of hydrochlorothiazide for test and reference product has been presented.|||88.74|77.37|
73995772|NCT03031496|147538058|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|103.92|||||TWO_SIDED|90.0|97.42|110.86|||||Comparison of Cmax of amiloride for test and reference product has been presented.|||110.86|97.42|
73995773|NCT03031496|147538059|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|92.37|||||TWO_SIDED|90.0|88.75|96.12|||||Comparison of Tmax of hydrochlorothiazide for test and reference product has been presented.|||96.12|88.75|
73995774|NCT03031496|147538059|OTHER||Least square mean ratio|101.47|||||TWO_SIDED|90.0|97.84|105.23|||||Comparison of Tmax of amiloride for test and reference product has been presented.|||105.23|97.84|
73995775|NCT01254552|147538073|OTHER||rate|0.071|||||TWO_SIDED|95.0|0.043|0.1||||||||0.100|0.043|
73995776|NCT00895895|147538095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.424|TWO_SIDED|95.0|-1.0|2.3|||Mixed Models Analysis|Mixed Model with repeated measures: change=Mini Mental State Examination (MMSE) Japan baseline baseline times(\*)visit visit treatment treatment\*visit.||Analysis of adjusted difference in change from baseline.||2.3|-1.0|0.424
73995777|NCT00895895|147538095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.849|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change equals (=) MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.5|-1.8|0.849
73995778|NCT00895895|147538095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.52|TWO_SIDED|95.0|-2.2|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-2.2|0.520
73995779|NCT00895895|147538095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.258|TWO_SIDED|95.0|-2.6|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-2.6|0.258
73995780|NCT00895895|147538096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.367|TWO_SIDED|95.0|-5.2|1.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.9|-5.2|0.367
73995781|NCT00895895|147538096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.91|TWO_SIDED|95.0|-3.3|3.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||3.7|-3.3|0.910
73995782|NCT00895895|147538096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.16|TWO_SIDED|95.0|-1.0|6.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.0|-1.0|0.160
73995783|NCT00895895|147538096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.06|TWO_SIDED|95.0|-0.1|6.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.9|-0.1|0.060
73995784|NCT00895895|147538097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.931|TWO_SIDED|95.0|-2.8|3.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||3.1|-2.8|0.931
73995785|NCT00895895|147538097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.054|TWO_SIDED|95.0|-5.8|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.1|-5.8|0.054
73995786|NCT00895895|147538097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.246|TWO_SIDED|95.0|-4.6|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-4.6|0.246
74090242|NCT01138111|147733772|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||The 24 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0008
74090243|NCT00775684|147733786|SUPERIORITY||||||=|0.1|||||||t-test, 2 sided|||Student t test||||=0.1
74090244|NCT00775684|147733786|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Repeated measure (baseline and 6 months)||||< 0.05
74090245|NCT00775684|147733787|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||Within group changes over 6 months (delta= final - baseline) were compared.||||>0.1
73995787|NCT00895895|147538097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.426|TWO_SIDED|95.0|-4.1|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-4.1|0.426
73995788|NCT00895895|147538098|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.265
73995789|NCT00895895|147538098|SUPERIORITY_OR_OTHER|||||||0.682|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.682
73995790|NCT00895895|147538098|SUPERIORITY_OR_OTHER|||||||0.532|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.532
73995791|NCT00895895|147538098|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.087
73995792|NCT00895895|147538098|SUPERIORITY_OR_OTHER|||||||0.751|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.751
73995793|NCT00895895|147538099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.553|TWO_SIDED|95.0|-3.9|7.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.3|-3.9|0.553
73995794|NCT00895895|147538099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.886|TWO_SIDED|95.0|-6.0|5.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||5.2|-6.0|0.886
73995795|NCT00895895|147538099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.712|TWO_SIDED|95.0|-6.6|4.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||4.5|-6.6|0.712
73995796|NCT00895895|147538099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.785|TWO_SIDED|95.0|-4.8|6.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.4|-4.8|0.785
73995797|NCT00895895|147538100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.251|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.1|-0.5|0.251
74090246|NCT00775684|147733788|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||To determine if exenatide or sitagliptin induced significant changes from baseline, the change for each measure (Δ = final - baseline) for each group was compared with the change in the glimepiride group using independent Student t tests||||>0.1
74090247|NCT00775684|147733789|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||||||>0.1
74090248|NCT02999477|147733792|EQUIVALENCE|The null hypothesis is no change in the amount of PD-L1 expression from baseline to after a two-week run in of nabpaclitaxel. The test was using one-sided alpha (type I error) of 0.05. The margin is zero.||||||1|||||||McNemar|||||||1.0
74090249|NCT02999477|147733792|EQUIVALENCE|The null hypothesis is no change in the amount of PD-L1 expression from baseline to after a two-week run in of nabpaclitaxel or pembrolizumab. The test was using one-sided alpha (type I error) of 0.05.||||||1|||||||McNemar|||||||1.0
74090250|NCT04266795|147733812|SUPERIORITY||Hazard Ratio (HR)|0.99|||=|0.477|TWO_SIDED|95.0|0.61|1.6|||Log Rank|P-value was comparison of EFS between treatment groups and was based on the 1-sided stratified log-rank test statistic.|Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (randomization strata of age and AML subtype) and treatment as a factor in the model.|||1.60|0.61|=0.477
74090251|NCT04818034|147733889|OTHER|paired t-test|paired t-test|0.965|STANDARD_DEVIATION|37.0||0.965|ONE_SIDED|96.0|||||paired t-test|||||||0.965
74090252|NCT00603291|147733890|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.14|||<|0.0001|TWO_SIDED|95.0|2.05|4.8|||Regression, Logistic|Adjustment for baseline body weight, baseline HbA1c stratum, and prior antihyperglycemic medication stratum||||4.80|2.05|<0.0001
74090253|NCT00603291|147733891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.06|||<|0.0001|TWO_SIDED|95.0|-3.92|-2.2|||ANCOVA|||||-2.20|-3.92|<0.0001
74090254|NCT04495283|147733898|SUPERIORITY||LS Mean Difference|-114.43|STANDARD_ERROR_OF_MEAN|26.65|<|0.001|ONE_SIDED|90.0||-80.01|||ANOVA|||||-80.01||<0.001
73995798|NCT00895895|147538100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.3|-0.3|0.993
73995799|NCT00895895|147538100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.553|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-0.4|0.553
73995800|NCT00895895|147538100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.611|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-0.4|0.611
73995801|NCT00895895|147538101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.34|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.5|-1.5|0.340
73995802|NCT00895895|147538101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.63|TWO_SIDED|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-0.8|0.630
74090255|NCT04495283|147733899|SUPERIORITY||LS Mean Difference|-70.16|STANDARD_ERROR_OF_MEAN|21.549|<|0.001|ONE_SIDED|90.0||-42.32|||ANOVA|||||-42.32||<0.001
73876853|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
73876854|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
73995803|NCT00895895|147538101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.678|TWO_SIDED|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-0.8|0.678
73995804|NCT00895895|147538101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.518|TWO_SIDED|95.0|-1.3|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-1.3|0.518
73995805|NCT00895895|147538102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.953|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-0.7|0.953
73995806|NCT00895895|147538102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.956|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.6|-0.7|0.956
73995807|NCT00895895|147538102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.216|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-1.1|0.216
73995808|NCT00895895|147538102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.665|TWO_SIDED|95.0|-0.8|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.5|-0.8|0.665
73995809|NCT00895895|147538103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.373|TWO_SIDED|95.0|-0.6|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-0.6|0.373
73995810|NCT00895895|147538103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.781|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.3|-1.0|0.781
73995811|NCT00895895|147538103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.417|TWO_SIDED|95.0|-0.7|1.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.6|-0.7|0.417
73995812|NCT00895895|147538103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.853|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.0|-1.3|0.853
73995813|NCT00895895|147538104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.428|TWO_SIDED|95.0|-2.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-2.6|0.428
73995814|NCT00895895|147538104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.763|TWO_SIDED|95.0|-2.1|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.5|-2.1|0.763
73995815|NCT00895895|147538104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.312|TWO_SIDED|95.0|-2.7|0.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.9|-2.7|0.312
73995816|NCT00895895|147538104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.215|TWO_SIDED|95.0|-3.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-3.0|0.215
73995817|NCT00895895|147538105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.956|TWO_SIDED|95.0|-2.7|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.5|-2.7|0.956
73995818|NCT00895895|147538105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-2.6|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.5|-2.6|0.988
73995819|NCT00895895|147538105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.89|TWO_SIDED|95.0|-2.7|2.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.4|-2.7|0.890
73995820|NCT00895895|147538105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.28|TWO_SIDED|95.0|-4.0|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-4.0|0.280
73995821|NCT00895895|147538106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.154|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-1.5|0.154
74090256|NCT02287909|147733945|SUPERIORITY||least square mean difference|-6.9|||>|0.05|TWO_SIDED|985.0|-38.0|24.0|||ANCOVA|||||24|-38|>0.05
73995822|NCT00895895|147538106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.74|TWO_SIDED|95.0|-1.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-1.0|0.740
73995823|NCT00895895|147538106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.179|TWO_SIDED|95.0|-1.4|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.3|-1.4|0.179
73995824|NCT00895895|147538106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.543|TWO_SIDED|95.0|-0.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-0.6|0.543
73995825|NCT00895895|147538107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.4||||0.861|TWO_SIDED|95.0|-739.7|618.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||618.8|-739.7|0.861
73995826|NCT00895895|147538107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-926.6||||0.007|TWO_SIDED|95.0|-1596.9|-256.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||-256.3|-1596.9|0.007
73995827|NCT00895895|147538107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|141.3||||0.676|TWO_SIDED|95.0|-522.1|804.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||804.6|-522.1|0.676
73995828|NCT00895895|147538107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|230.6||||0.505|TWO_SIDED|95.0|-449.7|910.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||910.9|-449.7|0.505
73995829|NCT00895895|147538108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.267|TWO_SIDED|95.0|-2.2|7.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.8|-2.2|0.267
73995830|NCT00895895|147538108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.145|TWO_SIDED|95.0|-1.3|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||8.6|-1.3|0.145
73995831|NCT00895895|147538108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.139|TWO_SIDED|95.0|-1.2|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||8.6|-1.2|0.139
73995832|NCT00895895|147538108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.386|TWO_SIDED|95.0|-2.8|7.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.2|-2.8|0.386
73995833|NCT00895895|147538109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.032|TWO_SIDED|95.0|-2.3|-0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||-0.1|-2.3|0.032
73995834|NCT00895895|147538109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.264|TWO_SIDED|95.0|-0.5|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-0.5|0.264
73995835|NCT00895895|147538109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.893|TWO_SIDED|95.0|-1.0|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-1.0|0.893
73995836|NCT00895895|147538109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.525|TWO_SIDED|95.0|-0.7|1.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.4|-0.7|0.525
73995837|NCT00895895|147538110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|60.9||||0.056|TWO_SIDED|95.0|-1.6|123.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||123.5|-1.6|0.056
73995838|NCT00895895|147538110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.8||||0.488|TWO_SIDED|95.0|-40.0|83.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||83.5|-40.0|0.488
73995839|NCT00895895|147538110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6||||0.783|TWO_SIDED|95.0|-52.6|69.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||69.8|-52.6|0.783
73995840|NCT00895895|147538110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6||||0.578|TWO_SIDED|95.0|-44.6|79.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||79.8|-44.6|0.578
73995841|NCT00895895|147538111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.1||||0.175|TWO_SIDED|95.0|-13.9|76.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||76.1|-13.9|0.175
73995842|NCT00895895|147538111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.0||||0.352|TWO_SIDED|95.0|-23.3|65.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||65.4|-23.3|0.352
73995843|NCT00895895|147538111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7||||0.797|TWO_SIDED|95.0|-38.1|49.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||49.6|-38.1|0.797
74090257|NCT01032018|147733946|SUPERIORITY_OR_OTHER||Difference of back-transformed means.|-3.5||||0.01||95.0|-6.1|-0.7|||Mixed Models Analysis|||The trial was powered to detect a between-group difference in the 6-month change in depression symptoms. Assuming 5% attrition rate, we estimated that a sample of 150 patients would be needed to have 80% power to detect a clinically meaningful differential change in depression scores between groups of 0.46 SD.||-0.7|-6.1|0.01
73995844|NCT00895895|147538111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.633|TWO_SIDED|95.0|-55.6|33.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||33.9|-55.6|0.633
73995845|NCT00895895|147538112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.2||||0.066|TWO_SIDED|95.0|-4.7|147.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||147.0|-4.7|0.066
73995846|NCT00895895|147538112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0||||0.598|TWO_SIDED|95.0|-54.6|94.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||94.7|-54.6|0.598
73995847|NCT00895895|147538112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.766|TWO_SIDED|95.0|-62.9|85.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||85.3|-62.9|0.766
73995848|NCT00895895|147538112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.8||||0.378|TWO_SIDED|95.0|-41.5|109.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||109.1|-41.5|0.378
73995849|NCT00895895|147538113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5||||0.481|TWO_SIDED|95.0|-40.2|85.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||85.2|-40.2|0.481
73995850|NCT00895895|147538113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.894|TWO_SIDED|95.0|-57.5|65.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||65.9|-57.5|0.894
73995851|NCT00895895|147538113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.991|TWO_SIDED|95.0|-61.5|60.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||60.8|-61.5|0.991
73995852|NCT00895895|147538113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.5||||0.422|TWO_SIDED|95.0|-87.9|36.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||36.9|-87.9|0.422
73995853|NCT00895895|147538114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.581|TWO_SIDED|95.0|0.24|2.22|||Regression, Logistic|||||2.22|0.24|0.581
73876855|NCT02365649|147294850|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
73995854|NCT00895895|147538114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.77|TWO_SIDED|95.0|0.42|3.19|||Regression, Logistic|||||3.19|0.42|0.770
73995855|NCT00895895|147538114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.216|TWO_SIDED|95.0|0.71|4.55|||Regression, Logistic|||||4.55|0.71|0.216
73995856|NCT00895895|147538114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.037|TWO_SIDED|95.0|1.06|6.42|||Regression, Logistic|||||6.42|1.06|0.037
74090258|NCT01939496|147733990|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-3.29|STANDARD_ERROR_OF_MEAN|1.748||0.062|TWO_SIDED|95.0|-6.743|0.163|||ANCOVA|||||0.163|-6.743|0.062
74090259|NCT01939496|147733990|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-4.93|STANDARD_ERROR_OF_MEAN|1.75||0.006|TWO_SIDED|95.0|-8.382|-1.469|||ANCOVA|||||-1.469|-8.382|0.006
73995857|NCT02284009|147538147|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|0.0|0.24|||||Analysis was performed using a Bayesian model incorporating historical placebo data using a robust mixture prior. Values above are 95% credible intervals. Probability of treatment difference (Albiglutide - Placebo) \>= 0.2 nmol/L = 0.097.|||0.24|0.00|
73995858|NCT04833127|147538296|EQUIVALENCE|Null hypothesis: no difference between the groups|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.56|1.8||generalized linear models (GLM) and generalized estimating equations (GEE) for clustering within recruitment chain|GLM (logit link) with GEE|||||1.80|0.56|1.0
73995859|NCT04833127|147538296|EQUIVALENCE|Null H: No difference between the groups|Odds Ratio (OR)|1.13||||0.69|TWO_SIDED|95.0|0.62|2.07||GLM with GEE to account for clustering by recruitment chain.|GLM (logit link) with GEE|Adjusted for age, education, if has a main male partner, which differed between the two groups at baseline.||||2.07|0.62|0.69
73995860|NCT04833127|147538297|EQUIVALENCE|Null hypothesis: No difference between the groups.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.35|2.85|||GLM with GEE|GLM with GEE accounting for clustering by recruitment chain||||2.85|0.35|1.00
73995861|NCT04833127|147538297|EQUIVALENCE|Null H: No difference between the 2 groups|Odds Ratio (OR)|0.95||||0.927|TWO_SIDED|95.0|0.31|2.9||GLM (logit link) with GEE to account for clustering by recruitment chain|GLM (logit link) with GEE|adjusted for baseline differences in age, educational status, and whether has a primary male partner.||||2.90|0.31|0.927
73995862|NCT04833127|147538298|EQUIVALENCE|Null Hypothesis: No difference between the groups|Odds Ratio (OR)|1.72||||0.215|TWO_SIDED|95.0|0.73|4.04|||GLM (logit link) with GEE|Used GEE to account for clustering by recruitment chain.||||4.04|0.73|0.215
73995863|NCT04833127|147538298|EQUIVALENCE|Null hypothesis: No difference between the groups|Odds Ratio (OR)|1.64||||0.295|TWO_SIDED|95.0|0.65|4.13|||GLM (logit link) with GEE|GEE used to account for clustering by recruitment chain|adjusted for baseline differences in age, education, and whether has a main male partner.|||4.13|0.65|0.295
74090260|NCT02274844|147734048|SUPERIORITY|The outcomes were all continuous or ordinal measures, thus unadjusted hypothesis tests used t-tests or the Wilcoxon-Mann-Whitney test, as appropriate, and statistical modeling used linear regression. ANCOVA was used to adjust for baseline covariates with imbalance across treatment arms (race) and baseline values of the measures.|Mean Difference (Final Values)|-0.09||||0.22|TWO_SIDED|95.0|-0.23|0.05||The main hypotheses tested were that intervention participants would have higher medication adherence and significantly greater improvement in A1c, BP, LDL-C, and measures of quality of life, and self-efficacy compared to control participants.|ANCOVA|||The study was powered to detect clinically meaningful differences in physiologic risk factors; it had four primary outcomes.Power estimates accounted for clustering of patients within towns, using a variance inflation factor, conservatively estimating power for ICC=0.01-0.05. Process measures were selected to understand which aspects of the intervention were particularly effective, assessing both program satisfaction and peer coach effectiveness.||0.05|-0.23|0.22
74090261|NCT02712333|147734065|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|7.53|||<|0.05|TWO_SIDED|95.0|4.65|10.41||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum cortisol levels (presented as relative intensities in high perfomance liquid chromatography-mass spectrum) by treatments (intervention group vs control group)||10.41|4.65|<0.05
74090262|NCT02712333|147734065|SUPERIORITY_OR_OTHER||fold change|1.33|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
74090263|NCT02712333|147734066|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|3.69|||<|0.01|TWO_SIDED|95.0|1.85|5.54||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum cortisone levels by treatment (intervention group vs control group)||5.54|1.85|<0.01
74090264|NCT02712333|147734066|SUPERIORITY_OR_OTHER||fold change|1.18|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
73995864|NCT00461981|147538309|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-60.6||||||95.0|-79.7|-31.7||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-31.7|-79.7|
73995865|NCT00461981|147538310|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-60.9||||||95.0|-83.8|-26.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-26.0|-83.8|
73995866|NCT00461981|147538311|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|44.2||||||95.0|12.0|67.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||67.8|12.0|
73995867|NCT00461981|147538312|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|16.2||||||95.0|-17.6|45.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||45.4|-17.6|
73995868|NCT00461981|147538313|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-18.2||||||95.0|-40.0|4.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||4.9|-40.0|
73995869|NCT00461981|147538314|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-5.6||||||95.0|-27.4|13.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||13.3|-27.4|
73995870|NCT00461981|147538315|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|35.7||||||95.0|9.5|57.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||57.1|9.5|
73995871|NCT00461981|147538316|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-5.0||||||95.0|-27.7|16.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||16.0|-27.7|
73995872|NCT00461981|147538317|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|14.7||||||95.0|-6.5|38.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||38.4|-6.5|
73995873|NCT00461981|147538318|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|38.1||||||95.0|0.9|65.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||65.9|0.9|
74090265|NCT02712333|147734067|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|5.17|||<|0.01|TWO_SIDED|95.0|3.21|7.14||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum epinephrine levels by treatment (intervention group vs control group)||7.14|3.21|<0.01
74090266|NCT02712333|147734067|SUPERIORITY_OR_OTHER||fold change|1.2|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
74090267|NCT02712333|147734068|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|11.28|||<|0.01|TWO_SIDED|95.0|7.37|15.21||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum norepinephrine levels by treatment (intervention group vs control group)||15.21|7.37|<0.01
74090268|NCT02712333|147734068|SUPERIORITY_OR_OTHER||fold change|1.57|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
74090269|NCT02712333|147734069|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|0.84|||<|0.01|TWO_SIDED|95.0|0.09|1.59|||Mixed Models Analysis|||we analyzed the serum SBP levels by treatment (intervention group vs control group)||1.59|0.09|<0.01
74090270|NCT02712333|147734070|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|0.31|||>|0.05|TWO_SIDED|95.0|-1.59|0.96|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)||0.96|-1.59|>0.05
74090271|NCT02712333|147734071|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|1.24|||>|0.05|TWO_SIDED|95.0|-1.14|3.63|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)||3.63|-1.14|>0.05
74090272|NCT05528861|147734104|SUPERIORITY||LSM Difference from Placebo|0.5|STANDARD_ERROR_OF_MEAN|2.1||0.8174|TWO_SIDED|95.0|-3.6|4.5|||ANCOVA|||||4.5|-3.6|0.8174
74090273|NCT05528861|147734105|SUPERIORITY||LSM Difference from Placebo|0.6|STANDARD_ERROR_OF_MEAN|1.1||0.5857|TWO_SIDED|95.0|-1.6|2.8|||Mixed Models Analysis|||||2.8|-1.6|0.5857
73995874|NCT00461981|147538319|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|11.7||||||95.0|-13.0|34.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||34.9|-13.0|
74090274|NCT05528861|147734106|SUPERIORITY||LSM Difference from Placebo|-0.1|STANDARD_ERROR_OF_MEAN|1.1||0.9633|TWO_SIDED|95.0|-2.2|2.1|||Mixed Models Analysis|||||2.1|-2.2|0.9633
74090275|NCT05528861|147734107|SUPERIORITY||Risk Difference (RD)|6.25||||0.1201|TWO_SIDED|95.0|-11.4|23.78|||Fisher Exact|||||23.78|-11.40|0.1201
74090276|NCT01602172|147734110|EQUIVALENCE|Results of the regression models were used to reject null hypotheses of equivalence with p-values of comparisons across groups in changes in alcohol related measures using p-values \< 0.05 as significant.||||||0.05||||||First, significance of the regression model was viewed. When the overall model was significant, tests of the co-efficients were viewed. Primary effects of interest were the treatment group X time interactions.|Mixed Models Analysis|||Measures were compared with linear mixed effects regression models to compare impact of BI compared to usual care conditions. Analyses reported here included only those that completed the 6 month interview (71/82 baseline participants).||||.05
74091677|NCT04972123|147737031|SUPERIORITY|The primary end point was evaluated via a large sample Z-test for proportions. The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.||||||0.521||||||The primary end point was evaluated via a large sample Z-test for proportions. The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.|Large sample Z-test for population prop|The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.||Primary endpoint -- ITT primary endpoint analysis||||0.521
73995875|NCT00461981|147538320|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-15.8||||||95.0|-40.7|8.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||8.0|-40.7|
73995876|NCT00461981|147538321|SUPERIORITY_OR_OTHER_LEGACY||GMT ratio|0.43||||||95.0|0.24|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.87|0.24|
73995877|NCT00461981|147538322|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.2||||||95.0|0.09|0.48||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.48|0.09|
74091678|NCT04972123|147737032|SUPERIORITY|Time to event was compared between groups via a log-rank test.||||||0.574||||||Time to event was compared between groups via a log-rank test.|Log Rank|||Secondary endpoint -- Time to event for evaluable ITT population who had a primary event.||||0.574
74091679|NCT04972123|147737033|SUPERIORITY|Incidence of asystole were compared between groups using Fisher exact test.||||||1||||||Incidence of asystole were compared between groups using Fisher exact test.|Fisher Exact|Incidence of asystole were compared between groups using Fisher exact test.||Secondary endpoint -- Incidence of asystolic pause \> 3 seconds for evaluable ITT population who had a primary event.||||1.000
73995878|NCT00461981|147538323|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|3.36||||||95.0|1.54|7.13||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||7.13|1.54|
73995879|NCT00461981|147538324|SUPERIORITY_OR_OTHER_LEGACY||GMT ratio|3.26||||||95.0|1.44|7.19||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||7.19|1.44|
73995880|NCT00461981|147538325|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.06||||||95.0|0.56|1.96||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.96|0.56|
73995881|NCT00461981|147538326|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.58||||||95.0|0.31|1.12||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.12|0.31|
73995882|NCT00461981|147538327|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|2.4||||||95.0|1.48|3.97||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.97|1.48|
73995883|NCT00461981|147538328|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.48||||||95.0|0.27|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.87|0.27|
73995884|NCT00461981|147538329|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.45||||||95.0|0.8|2.66||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||2.66|0.80|
74035982|NCT02491073|147624438|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator.|1.02|0.99|
74035983|NCT02491073|147624438|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Slope|1.01|||||TWO_SIDED|90.0|1.0|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.033|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.02|1.00|
74035984|NCT02491073|147624438|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.036|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.99|
74035985|NCT02491073|147624438|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.047|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.98|
74035986|NCT02491073|147624438|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.043|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.98|
74035987|NCT02491073|147624438|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.97|1.0|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.048|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.00|0.97|
73995885|NCT00461981|147538330|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.75||||||95.0|0.88|3.39||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.39|0.88|
73995886|NCT00461981|147538331|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.49||||||95.0|0.8|2.69||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||2.69|0.80|
73995887|NCT00461981|147538332|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.62||||||95.0|0.33|1.16||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.16|0.33|
73995888|NCT00461981|147538333|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-45.9||||||95.0|-71.7|-11.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-11.6|-71.7|
73995889|NCT00461981|147538334|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-25.0||||||95.0|-57.2|4.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||4.8|-57.2|
73995890|NCT00461981|147538335|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|65.0||||||95.0|34.4|85.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||85.3|34.4|
73995891|NCT00461981|147538336|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-0.6||||||95.0|-30.4|30.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||30.3|-30.4|
73995892|NCT00461981|147538337|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-37.0||||||95.0|-57.8|-17.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-17.5|-57.8|
74035988|NCT02491073|147624439|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.06|1.16|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.148|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.16|1.06|
74035989|NCT02491073|147624439|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.13|||||TWO_SIDED|90.0|1.07|1.2|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.202|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.20|1.07|
73995893|NCT00461981|147538338|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-8.3||||||95.0|-38.5|14.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||14.5|-38.5|
73995894|NCT00461981|147538339|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|21.9||||||95.0|-6.7|48.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||48.1|-6.7|
74035990|NCT02491073|147624439|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.04|1.18|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.18|1.04|
74091680|NCT04972123|147737034|SUPERIORITY|Reporting for the 1 hour fatigue score only.||||||0.732||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.732
73995895|NCT00461981|147538340|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-22.4||||||95.0|-54.4|12.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||12.2|-54.4|
73995896|NCT00461981|147538341|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|33.3||||||95.0|-81.1|90.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||90.6|-81.1|
73995897|NCT00461981|147538342|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|0.0||||||95.0|-97.5|84.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||84.2|-97.5|
73995898|NCT00461981|147538343|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-9.5||||||95.0|-65.2|58.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||58.8|-65.2|
73995899|NCT00461981|147538344|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-20.0||||||95.0|-71.6|33.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||33.9|-71.6|
73995900|NCT00461981|147538345|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.23||||||95.0|0.15|0.35||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.35|0.15|
73995901|NCT00461981|147538346|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.11||||||95.0|0.05|0.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.22|0.05|
73995902|NCT00461981|147538347|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|4.85||||||95.0|2.51|9.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||9.22|2.51|
73995903|NCT00461981|147538348|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|3.31||||||95.0|1.46|7.54||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||7.54|1.46|
73995904|NCT00461981|147538349|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.35||||||95.0|0.58|3.04||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.04|0.58|
73995905|NCT00461981|147538350|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.44||||||95.0|0.16|1.07||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.07|0.16|
73995906|NCT00461981|147538351|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|2.46||||||95.0|1.26|5.06||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||5.06|1.26|
73995907|NCT00461981|147538352|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.89||||||95.0|0.7|1.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.00|0.70|
73995908|NCT00461981|147538353|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.51||||||95.0|0.23|1.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.22|0.23|
73995909|NCT00461981|147538354|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|4.0||||||95.0|4.0|4.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||4.00|4.00|
73995910|NCT00461981|147538355|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.8||||||95.0|0.22|3.63||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.63|0.22|
73995911|NCT00461981|147538356|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.66||||||95.0|0.25|1.73||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.73|0.25|
73995912|NCT00461981|147538361|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence|||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
73995913|NCT03301155|147538402|SUPERIORITY|||||||0.001|||||||Regression, Logistic|Comparison performed on the regression parameters scale. Estimates for mean time obtained under assumption of exponentially distributed time-to-event.||||||0.001
73995914|NCT03301155|147538402|SUPERIORITY|superiority margin for hazard ratio was prespecified as 0.846. Lower hazard is better thus the upper confidence limit of HR expected to be lesser than margin|Hazard Ratio (HR)|0.645||||0.0218|TWO_SIDED|95.0|0.496|0.839|||Regression, Cox||Lower HR is better|||0.839|0.496|0.0218
73995915|NCT03301155|147538403|SUPERIORITY|||||||0.0003||||||Adjusted with Holm method for multiple comparrisons|Fisher Exact|||Comparison between groups on week 4||||0.0003
73995916|NCT03301155|147538403|SUPERIORITY|Adjusted with Holm method for multiple comparrisons||||||0.0003|||||||Fisher Exact|||Comparison between groups on week 8||||0.0003
73995917|NCT03301155|147538403|SUPERIORITY|||||||0.0021|||||||Fisher Exact|||Comparison between groups on week 12||||0.0021
73995918|NCT03301155|147538404|SUPERIORITY|||||||0.1372|||||||Fisher Exact|||||||0.1372
73995919|NCT03301155|147538405|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
73995920|NCT03301155|147538406|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
73995921|NCT00731133|147538407|SUPERIORITY_OR_OTHER||Slope|2.6466|STANDARD_ERROR_OF_MEAN|0.9016||0.05|TWO_SIDED|95.0|0.7858|4.5073|||Mixed Models Analysis|7,24||Open-label study testing for change in side-effects ratings over time (i.e., slope).||4.5073|.7858|0.05
73995922|NCT00731133|147538408|SUPERIORITY_OR_OTHER||Slope|-0.373|STANDARD_ERROR_OF_MEAN|0.2196||0.05|TWO_SIDED|95.0|-0.8075|0.0615|||Mixed Models Analysis|7,24||Open label study testing changes in amphetamine use over time (i.e., slope).||0.06150|-0.8075|0.05
74035991|NCT02491073|147624439|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.99|1.1|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.179|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.10|0.99|
73995923|NCT00384189|147538429|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|4.3||0.0116|TWO_SIDED|95.0|1.4|18.3|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||18.3|1.4|0.0116
73995924|NCT00384189|147538429|SUPERIORITY_OR_OTHER||Least Square Means Difference|9.4|STANDARD_ERROR_OF_MEAN|4.3||0.0148|TWO_SIDED|95.0|0.9|17.8|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||17.8|0.9|0.0148
73995925|NCT00384189|147538429|SUPERIORITY_OR_OTHER||Least Squares Means Difference|12.0|STANDARD_ERROR_OF_MEAN|4.3||0.0028|TWO_SIDED|95.0|3.5|20.4|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||20.4|3.5|0.0028
73995926|NCT00384189|147538430|SUPERIORITY_OR_OTHER|||||||0.1362||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.1362
73995927|NCT00384189|147538430|SUPERIORITY_OR_OTHER|||||||0.0891||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.0891
73995928|NCT00384189|147538430|SUPERIORITY_OR_OTHER|||||||0.1574||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.1574
73995929|NCT00384189|147538431|SUPERIORITY_OR_OTHER|||||||0.001||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0010
73995930|NCT00384189|147538431|SUPERIORITY_OR_OTHER|||||||0.0006||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0006
73995931|NCT00384189|147538431|SUPERIORITY_OR_OTHER|||||||0.0002||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0002
73995932|NCT01399697|147538483|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||ANCOVA|||||||0.700
73995933|NCT01399697|147538484|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED||||||Chi-squared|||||||0.328
73995934|NCT01399697|147538485|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED||||||Chi-squared|||||||0.518
73995935|NCT01399697|147538486|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||Chi-squared|||||||0.358
73995936|NCT01399697|147538487|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Mean|0.032||||0.674|TWO_SIDED|95.0|-0.119|0.184|||ANCOVA||Analysis of covariance (ANCOVA) model with treatment as factor and DAS28 value at Week 16 as covariate.|||0.184|-0.119|0.674
73995937|NCT01399697|147538488|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.873||||0.204|TWO_SIDED|95.0|-4.775|1.03|||ANCOVA||ANCOVA model with treatment as factor and mental component score (MCS) as covariate.|||1.030|-4.775|0.204
73995938|NCT01399697|147538489|SUPERIORITY_OR_OTHER||Difference in LS Mean|3.376||||0.015|TWO_SIDED|95.0|0.676|6.076|||ANCOVA||ANCOVA model with treatment as factor and physical component score (PCS) as covariate.|||6.076|0.676|0.015
73995939|NCT01399697|147538490|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.969||||0.769|TWO_SIDED|95.0|-5.526|7.464|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the participant at Week 16 as a covariate.|||7.464|-5.526|0.769
73995940|NCT01399697|147538491|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.216||||0.655|TWO_SIDED|95.0|-6.573|4.141|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the investigator at Week 16 as covariate.|||4.141|-6.573|0.655
73995941|NCT02579135|147538493|SUPERIORITY|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.32|TWO_SIDED||||||Regression, Linear|||Third, to assess the effectiveness of the HEART intervention from pretest to immediate posttest, we used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.||||.32
73995942|NCT02579135|147538494|SUPERIORITY|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|8.31|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED||||||Regression, Linear|||We used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.||||<.001
73995943|NCT01146600|147538495|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|ANOVA, comparing baseline, clarithromycin, and placebo||||||0.47
73995944|NCT01146600|147538496|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.63
73995945|NCT01146600|147538497|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.64
73995946|NCT01146600|147538498|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.002
73995947|NCT01146600|147538499|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.002
73876856|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|15.0||||0.536|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||30.6|-0.6|0.536
73995948|NCT01146600|147538500|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.01
73995949|NCT01146600|147538501|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.76
73995950|NCT02964325|147538511|NON_INFERIORITY|An NI analysis was carried out to assess the primary efficacy endpoint with the null hypothesis being the MIRASOL group is inferior to the CONTROL group and the alternative hypothesis being the MIRASOL group is non-inferior to the CONTROL group. In this study, the NI margin was 1.6.|Relative Rate|2.79|||||TWO_SIDED|95.0|1.67|4.67|||||The MIRASOL group represents the numerator and the CONTROL group represents the denominator for the relative rate. For days during off-protocol intervals, bleeding data were simulated using an estimate of the individual-specific bleeding rate.|The MIRASOL and CONTROL groups were compared with respect to the number of days of WHO ≥ Grade 2 bleeding. This was carried out by fitting a negative binomial regression model with an offset defined as the natural logarithm (LN) of the number of days that bleeding was assessed in order to account for the fact that subjects had different numbers of bleeding assessment days.||4.67|1.67|
73995951|NCT02964325|147538513|NON_INFERIORITY|A non-inferiority margin of 1.2 was used to evaluated this endpoint.|Relative Risk|1.32||||0.7274|TWO_SIDED|95.0|0.97|1.81|||Wald Non-inferiority Test||The MIRASOL group represents the numerator and the CONTROL group represents the denominator for the relative risk.|The null hypothesis was H0: pt/pc \> 1.2 (ie, MIRASOL had more than a 20% higher probability of a patient experiencing at least one WHO ≥ Grade 2 bleed compared to CONTROL).||1.81|0.97|0.7274
73995952|NCT02964325|147538514|OTHER|||||||0.07|||||||Log-rank test|||||||0.07
73995953|NCT02964325|147538515|OTHER|||||||0.1649|||||||Fisher Exact|||||||0.1649
73995954|NCT02964325|147538516|OTHER||Risk Ratio (RR)|2.15||||0.0015|TWO_SIDED|95.0|1.32|3.49|||Fisher Exact|||||3.49|1.32|0.0015
73995955|NCT00588692|147538606|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For 25-49% Ejection Fraction Subgroup||||<0.05
73995956|NCT00588692|147538606|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||35-49% Ejection Fraction Subgroup||||<0.05
73995957|NCT00588692|147538608|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||||||0.06
73995958|NCT00588692|147538609|SUPERIORITY_OR_OTHER|||||||0.5|||||||ANOVA|||||||0.5
73995959|NCT00588692|147538609|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995960|NCT00588692|147538609|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995961|NCT00588692|147538610|SUPERIORITY_OR_OTHER|||||||0.26|||||||ANOVA|||||||0.26
73995962|NCT00588692|147538610|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995963|NCT00588692|147538610|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995964|NCT00588692|147538611|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|||||||0.4
73995965|NCT00588692|147538612|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
73995966|NCT00588692|147538612|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
74090277|NCT00518882|147734115|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test is below 0.4%|Estimated treatment difference, LS Mean|-0.33|||<|0.0001||95.0|-0.47|-0.18||No multiplicity concerns|ANCOVA|||"ANCOVA with treatment, country and previous OAD treatment as fixed effects and baseline HbA1c as covariate.~2 hypotheses were tested: H01: µliraglutide ≥ µexenatide + Δ, HA1: µliraglutide \< µexenatide + Δ; Δ=0.4%. If non-inferiority was concluded, a test for superiority was established by a 1-sided test of the hypothesis H02: µliraglutide ≥ µexenatide against HA2: µliraglutide \< µexenatide. Superiority was concluded if the upper limit of the 2-sided 95% CI for the difference was below 0%."||-0.18|-0.47|<.0001
74090278|NCT00518882|147734116|SUPERIORITY_OR_OTHER||Mean|0.25|STANDARD_DEVIATION|0.803|<|0.0001||95.0|0.139|0.364|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.364|0.139|<0.0001
74090279|NCT00518882|147734116|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.924||0.9872||95.0|-1.36|0.134|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.134|-1.36|0.9872
74090280|NCT00518882|147734117|SUPERIORITY_OR_OTHER||Mean|-0.98|STANDARD_DEVIATION|1.119|<|0.0001||95.0|-1.137|-0.823|||Paired t-test|||The analysis was made with a paired t test within the treatment group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.||-0.823|-1.137|<0.0001
73995967|NCT00588692|147538612|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
74090281|NCT00518882|147734117|SUPERIORITY_OR_OTHER||Mean|-0.85|STANDARD_DEVIATION|1.105|<|0.0001||95.0|-1.01|-0.687|||Paired t-test|||The analysis was made with a paired t test within the exenatide→liraglutide group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.||-0.687|-1.010|<0.0001
73995968|NCT00588692|147538613|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
73995969|NCT00588692|147538614|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
73995970|NCT00588692|147538615|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||||||0.3
73995971|NCT00588692|147538616|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
73995972|NCT00588692|147538616|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995973|NCT00588692|147538616|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
73995974|NCT00588692|147538617|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANOVA|||||||0.6
74090282|NCT00518882|147734120|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.38||||0.2235||95.0|-0.99|0.23||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline body weight as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the body weight in the liraglutide arm and exenatide arm, respectively.||0.23|-0.99|0.2235
73995975|NCT00588692|147538618|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
73995976|NCT00588692|147538618|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995977|NCT00588692|147538618|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995978|NCT00588692|147538619|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||||||0.11
73995979|NCT00588692|147538619|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995980|NCT00588692|147538619|SUPERIORITY_OR_OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
73995981|NCT00588692|147538620|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|||||||0.4
73995982|NCT00588692|147538620|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995983|NCT00588692|147538620|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995984|NCT00588692|147538621|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
73995985|NCT00588692|147538621|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995986|NCT00588692|147538621|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
73995987|NCT01077518|147538658|SUPERIORITY||Stratified Cox propor.hazards regression|0.82||||0.139|TWO_SIDED|95.0|0.62|1.07|||Stratified Log-Rank|||||1.07|0.62|0.1390
73995988|NCT01077518|147538659|OTHER||Stratified Cox propor.hazards regression|0.76||||0.1076|TWO_SIDED|95.0|0.55|1.06|||Stratified Log-Rank|||||1.06|0.55|0.1076
73995989|NCT01077518|147538660|OTHER|||||||0.8003|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for All participants||||0.8003
73995990|NCT01077518|147538661|OTHER|||||||0.613|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for Follicular Lymphoma (FL) participants||||0.6130
73995991|NCT01077518|147538662|OTHER||Hazard Ratio (HR)|0.87||||0.4046|TWO_SIDED|95.0|0.62|1.21|||Stratified Log Rank|||for All patients||1.21|0.62|0.4046
73995992|NCT01077518|147538663|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3768|TWO_SIDED|95.0|0.55|1.25|||Stratified Log Rank|||for FL participants||1.25|0.55|0.3768
73995993|NCT02387970|147538686|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
73995994|NCT02387970|147538687|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||||||0.235
73995995|NCT02387970|147538688|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||||||0.165
73995996|NCT02387970|147538689|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
73995997|NCT02387970|147538690|SUPERIORITY|||||||0.121|||||||t-test, 2 sided|||||||0.121
73995998|NCT02387970|147538691|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|||||||0.248
73995999|NCT02387970|147538692|SUPERIORITY|||||||0.854|||||||t-test, 2 sided|||||||0.854
73996000|NCT01310231|147538693|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.71|TWO_SIDED|95.0|0.63|2.31||One-sided p-value for group-effect obtained from Cox model. The prespecified threshold was 0.20 (one-sided).|Regression, Cox|Cox model for PFS with metf/plac and the two randomization stratification variables line of chemotherapy and hormone receptor status.|Ratio of hazard of progression in the Metformin group relative to hazard in the Placebo group|Power: Final study plan called for 40 progression events, giving 80% power to detect a hazard ratio (HR) of 0.58 for PFS with a one-sided type I error of 20%, where the relatively high type I error reflects the Phase II status of the trial||2.31|0.63|0.71
73996001|NCT01310231|147538694|SUPERIORITY||Odds Ratio (OR)|1.77||||0.41|TWO_SIDED|95.0|0.45|6.99||Two-side p-value from a logistic regression model.|Regression, Logistic|Logistic regression model included metf/plac and the two stratification variables line of chemotherapy and hormone receptor status.||||6.99|0.45|0.41
73996002|NCT04662060|147538703|OTHER||Hazard Ratio (HR)|0.6||||0.07|TWO_SIDED|95.0|0.34|1.04||A p-value of \<0.05 would be considered statistically significant.|Cox proportional hazards model|Two-sided Cox proportional hazards model adjusted for age, sex, and receipt of baseline receipt of monoclonal antibodies.||A two-sided log rank test at the 0.04999 level of significance for the final analysis required 78 events (i.e., sustained symptom resolution) to provide 80% power to detect a hazard ratio of 1.91. Based on previous outpatient COVID-19 trials at Stanford, assumed placebo and treatment arm median time to symptom resolution of 10 and 5 days, respectively, for a total sample size of 120 patients. Participants with missing data lasting through Day 28 were censored on Day 28.||1.04|0.34|0.07
73996003|NCT04662060|147538704|OTHER|||||||0.2||||||A p-value of \<0.05 would be considered statistically significant.|Linear mixed-effects regression model|||A generalized linear mixed effects model with parameterization was utilized to capture the difference in change in viral shedding at day 10 between treatment arms. SARS-CoV2 viral RNA CT values were transformed using a standard Reference curve.||||0.20
73996004|NCT04662060|147538706|OTHER||Hazard Ratio (HR)|0.62||||0.05|TWO_SIDED|95.0|0.38|1.01|||Linear mixed-effects regression model|||||1.01|0.38|0.05
73996005|NCT04662060|147538707|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.34|1.01||||||||1.01|0.34|
73996006|NCT04662060|147538708|OTHER|||||||0.21||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||Difference in incidence of ED visits||||0.21
73996007|NCT01495598|147538714|OTHER|Other = Kaplan Meier||||||0.43|||||||Log Rank|||||||0.43
73996008|NCT01495598|147538724|OTHER|\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.19||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.19
73996009|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.72||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.72
73996010|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.03
73996011|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
73996012|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
73996013|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
73996014|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.005||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.005
73996015|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.06
74090283|NCT00518882|147734121|SUPERIORITY_OR_OTHER||Mean|-0.4|STANDARD_DEVIATION|3.24||0.0793||95.0|-0.86|0.05|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.05|-0.86|0.0793
73996016|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
73996017|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0003||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0003
73996018|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0002||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0002
73996019|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.01||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.01
73996020|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.03
73996021|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.91||||||The reported p-value is representative of the changes in levels of IL10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.91
73996022|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.64||||||The reported p-value is representative of the changes in levels of IL10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.64
73996023|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.7||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.70
73996024|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.59||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.59
73996025|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.26||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.26
73996026|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0008||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0008
73996027|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
73996028|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
73996029|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.005||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.005
73996030|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
73996031|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
73996032|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.42||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.42
73996033|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.85||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.85
74091681|NCT04972123|147737034|SUPERIORITY|Reporting for the 4 hour fatigue score only.||||||0.591||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.591
73996034|NCT01495598|147538724|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.16||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.16
73996035|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.07||||||The reported p-value is representative of the changes in levels of CD4+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.07
74035992|NCT02491073|147624439|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.21|||||TWO_SIDED|90.0|1.15|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.178|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.52|1.15|
74039801|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.0058|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.88|0.0058
73996036|NCT01495598|147538725|NON_INFERIORITY|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.|Wilcoxon signed rank test|||||||0.13
73996037|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.15||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.|Wilcoxon signed rank test|||||||0.15
73996038|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.03
73996039|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.06
73996040|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.79||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon rank sum test|||||||0.79
73996041|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.03
73996042|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.008||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.008
73996043|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.12||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.12
73996044|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.02||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.02
73996045|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.02||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.02
73996046|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.36||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.36
73996047|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.002||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.002
73996048|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0002||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.0002
73996049|NCT01495598|147538725|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||<0.0001
73996050|NCT01495598|147538726|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.13|||||||Wilcoxon signed rank test|||||||0.13
73996051|NCT01495598|147538726|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.65|||||||Wilcoxon signed rank test|||||||0.65
73996052|NCT01495598|147538726|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.32|||||||Wilcoxon signed rank test|||||||0.32
73996053|NCT01495598|147538726|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06|||||||Wilcoxon signed rank test|||||||0.06
73996054|NCT01495598|147538726|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007|||||||Wilcoxon signed rank test|||||||0.007
73996055|NCT01495598|147538727|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
73996056|NCT01495598|147538727|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.65|||||||Wilcoxon signed rank test|||||||0.65
73996057|NCT01495598|147538727|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
73996058|NCT02671500|147538734|SUPERIORITY||||||<|0.001|||||||2-sided 1 sample exact binomial test|||A sample size of 260 participants in Region 1 would provide more than 80% power to detect an improvement of at least 6 percentage points in SVR12 rate from the performance goal of 85% by using a two-sided exact one-sample binomial test at the significance level of 0.05.||||<0.001
73996059|NCT05292586|147538774|SUPERIORITY||Adjusted mean difference|0.104|||<|0.001|TWO_SIDED|95.0|0.061|0.148|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.148|0.061|<0.001
73996060|NCT05292586|147538775|SUPERIORITY||Adjusted mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.076|0.173|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.173|0.076|<0.001
73996061|NCT05292586|147538776|SUPERIORITY||Adjusted mean difference|0.101|||<|0.001|TWO_SIDED|95.0|0.063|0.139|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.139|0.063|<0.001
73996062|NCT05292586|147538777|SUPERIORITY||Adjusted mean difference|0.113|||<|0.001|TWO_SIDED|95.0|0.071|0.154|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.154|0.071|<0.001
73996063|NCT05292586|147538778|SUPERIORITY||Adjusted mean difference|0.069||||0.003|TWO_SIDED|95.0|0.023|0.115|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.115|0.023|0.003
73996064|NCT05292586|147538779|SUPERIORITY||Adjusted mean difference|0.044||||0.05|TWO_SIDED|95.0|0.0|0.088|||ANCOVA|||"1\_Change from baseline -- Week 4~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.088|0.000|0.050
73996065|NCT05292586|147538779|SUPERIORITY||Adjusted mean difference|0.041||||0.098|TWO_SIDED|95.0|-0.007|0.089|||ANCOVA|||"2\_Change from baseline -- Week 8~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.089|-0.007|0.098
73996066|NCT05292586|147538779|SUPERIORITY||Adjusted mean difference|0.043||||0.056|TWO_SIDED|95.0|-0.001|0.086|||ANCOVA|||"3\_Change from baseline -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.086|-0.001|0.056
73996067|NCT05292586|147538780|SUPERIORITY||Odds Ratio (OR)|1.327||||0.098|TWO_SIDED|95.0|0.949|1.855|||Logistic regression model|||1\_Responders at Week 4||1.855|0.949|0.098
73996068|NCT05292586|147538780|SUPERIORITY||Odds Ratio (OR)|1.262||||0.18|TWO_SIDED|95.0|0.898|1.772|||Logistic regression model|||2\_Responders at Week 8||1.772|0.898|0.180
73996069|NCT05292586|147538780|SUPERIORITY||Odds Ratio (OR)|1.568||||0.009|TWO_SIDED|95.0|1.117|2.203|||Logistic regression model|||3\_Responders at Week 12||2.203|1.117|0.009
73996070|NCT05292586|147538781|SUPERIORITY||Odds Ratio (OR)|1.822|||<|0.001|TWO_SIDED|95.0|1.284|2.587|||Logistic regression model|||1\_Responders at Week 12||2.587|1.284|<0.001
73996071|NCT05292586|147538782|SUPERIORITY||Adjusted mean difference|8.78||||0.002|TWO_SIDED|95.0|3.3|14.27|||ANCOVA|||"1\_Change From Baseline; Week 0 -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||14.27|3.30|0.002
74090284|NCT00518882|147734121|SUPERIORITY_OR_OTHER||Mean|-0.7|STANDARD_DEVIATION|3.67||0.0075||95.0|-1.26|-0.2|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.20|-1.26|0.0075
73996072|NCT05292586|147538783|SUPERIORITY||Adjusted mean difference|8.73||||0.002|TWO_SIDED|95.0|3.32|14.14|||ANCOVA|||"1\_Change From Baseline; Week 0 -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||14.14|3.32|0.002
74090285|NCT00518882|147734122|SUPERIORITY_OR_OTHER||Mean|-3.3|STANDARD_DEVIATION|4.63|<|0.0001||95.0|-3.9|-2.61|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.61|-3.90|<0.0001
74090286|NCT00518882|147734122|SUPERIORITY_OR_OTHER||Mean|-3.2|STANDARD_DEVIATION|4.44|<|0.0001||95.0|-3.85|-2.55|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.55|-3.85|<0.0001
74090287|NCT00518882|147734123|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-1.01|||<|0.0001||95.0|-1.37|-0.65||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline fasting plasma glucose as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the fasting plasma glucose in the liraglutide and exenatide arm, respectively.||-0.65|-1.37|<0.0001
74090288|NCT00518882|147734124|SUPERIORITY_OR_OTHER||Mean|0.7|STANDARD_DEVIATION|1.84|<|0.0001||95.0|0.48|1.0|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78- µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||1.00|0.48|<0.0001
74090289|NCT00518882|147734124|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|2.42||0.4864||95.0|-0.48|0.23|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.23|-0.48|0.4864
74090290|NCT00518882|147734125|SUPERIORITY_OR_OTHER||Mean|-1.3|STANDARD_DEVIATION|2.5|<|0.0001||95.0|-1.62|-0.92|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.92|-1.62|<0.0001
74090291|NCT00518882|147734125|SUPERIORITY_OR_OTHER||Mean|-0.8|STANDARD_DEVIATION|2.76|<|0.0001||95.0|-1.23|-0.42|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.42|-1.23|<0.0001
74090292|NCT00518882|147734126|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|1.33|||<|0.0001||95.0|0.8|1.86||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.86|0.80|<.0001
74091682|NCT04972123|147737034|SUPERIORITY|Reporting for the 8 hour fatigue score only.||||||0.034||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.034
73996073|NCT05292586|147538784|SUPERIORITY||Adjusted mean difference|-0.112||||0.026|TWO_SIDED|95.0|-0.211|-0.013|||ANCOVA|||"1\_Change From Baseline in ACQ-7 at Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||-0.013|-0.211|0.026
73996074|NCT05292586|147538784|SUPERIORITY||Adjusted mean difference|0.02||||0.686|TWO_SIDED|95.0|-0.077|0.118|||ANCOVA|||"2\_Change from baseline in ACQ-5 at Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.118|-0.077|0.686
73996075|NCT05292586|147538785|SUPERIORITY||Adjusted mean difference|3.82||||0.033|TWO_SIDED|95.0|0.31|7.33|||ANCOVA|||"1\_Change From Baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||7.330|0.310|0.033
73996076|NCT05292586|147538786|SUPERIORITY||Adjusted mean difference|3.78||||0.078|TWO_SIDED|95.0|-0.425|7.985|||ANCOVA|||"1\_Change From Baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||7.985|-0.425|0.078
73996077|NCT04531982|147538787|SUPERIORITY|||||||0.4825||||||Two-sided p-value for treatment difference at Week 26 from MMRM analysis.|Mixed Models Analysis|||Difference between LSM changes for adjunctive pimavanserin and adjunctive placebo (pimavanserin - placebo) at the specified visit from MMRM analysis.||||0.4825
73996078|NCT04531982|147538788|SUPERIORITY|||||||0.8872||||||Two-sided p-value for treatment difference at Week 26 from MMRM analysis.|Mixed Models Analysis|||||||0.8872
73996079|NCT03841526|147538792|OTHER|Parameters that did not meet normality criterion were analyzed non-parametrically. Overall treatment effect was assessed using Friedman's test.||||||0.0002|||||||ANOVA|||The primary efficacy analysis was analyzed by analysis of variance (ANOVA) comparing the mean incidence rates among the 3 treatment groups in the Outpatient Phase. If the performed Friedman's test yielded an overall p-value less than 0.05, post-hoc analysis of groups means were conducted to statistically determine which group means differed.||||0.0002
74090293|NCT00518882|147734127|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.01||||0.9849||95.0|-0.52|0.53||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.53|-0.52|0.9849
74090294|NCT00518882|147734128|SUPERIORITY_OR_OTHER||LS Mean|1.01||||0.0005||95.0|0.44|1.57||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.57|0.44|0.0005
74090295|NCT00518882|147734129|SUPERIORITY_OR_OTHER||Mean|-0.22|STANDARD_DEVIATION|2.866||0.2972||95.0|-0.626|0.192|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.192|-0.626|0.2972
74090296|NCT00518882|147734129|SUPERIORITY_OR_OTHER||Mean|1.15|STANDARD_DEVIATION|3.253|<|0.0001||95.0|0.66|1.637|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.637|0.660|<0.0001
74090297|NCT00518882|147734130|SUPERIORITY_OR_OTHER||Mean|0.05|STANDARD_DEVIATION|3.307||0.8396||95.0|-0.424|0.521|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.521|-0.424|0.8396
74090298|NCT00518882|147734130|SUPERIORITY_OR_OTHER||Mean|-0.09|STANDARD_DEVIATION|3.419||0.7278||95.0|-0.604|0.423|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.423|-0.604|0.7278
73876857|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|15.0||||0.238|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||30.6|-0.6|0.238
73996080|NCT03841526|147538792|OTHER||||||<|0.0001|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||<0.0001
73996081|NCT03841526|147538792|OTHER|||||||0.0032|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||0.0032
73996082|NCT03841526|147538792|OTHER|||||||0.2072|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||0.2072
73996083|NCT03841526|147538795|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73996084|NCT03841526|147538796|OTHER|||||||0.859|||||||Chi-squared|||||||0.8590
74090299|NCT00518882|147734131|SUPERIORITY_OR_OTHER||Mean|0.22|STANDARD_DEVIATION|3.053||0.3271||95.0|-0.219|0.654|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.654|-0.219|0.3271
74090300|NCT00518882|147734131|SUPERIORITY_OR_OTHER||Mean|1.07|STANDARD_DEVIATION|3.775||0.0003||95.0|0.497|1.634|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.634|0.497|0.0003
73996085|NCT04854850|147538804|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73996086|NCT01123070|147538832|EQUIVALENCE|Bioequivalence declared if the back transformed 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.93||||0.4265|TWO_SIDED|90.0|0.797|1.084|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator and MabThera arm is the denominator|||1.084|0.797|0.4265
73996087|NCT01123070|147538833|EQUIVALENCE|Bioequivalence declared if the back transformed 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.862||||0.0368|TWO_SIDED|90.0|0.768|0.968|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator, MabThera arm is the denominator|||0.968|0.768|0.0368
73996088|NCT01123070|147538835|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.909||||0.1484|TWO_SIDED|90.0|0.814|1.014|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|Cmax1||1.014|0.814|0.1484
73876858|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-34.3|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||24.3|-34.3|1.000
73996089|NCT01123070|147538835|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.766||||0.0241|TWO_SIDED|90.0|0.633|0.927|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|Cmax2||0.927|0.633|0.0241
73996090|NCT01123070|147538836|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.969||||0.652|TWO_SIDED|90.0|0.863|1.088|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator, MabThera arm is the denominator|AUC1||1.088|0.863|0.6520
73996091|NCT01123070|147538836|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.961||||0.7835|TWO_SIDED|90.0|0.757|1.222|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|AUC2||1.222|0.757|0.7835
74035993|NCT02491073|147624439|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.42|||||TWO_SIDED|90.0|1.33|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.224|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.52|1.33|
73996092|NCT01498887|147538896|SUPERIORITY_OR_OTHER|||||||0.3118|||||||Wilcoxon (Mann-Whitney)|||||||0.3118
73996093|NCT03079297|147538903|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.5||0.4128|TWO_SIDED|95.0|-3.56|7.56|||t-test, 2 sided|||||7.56|-3.56|0.4128
73996094|NCT03079297|147538904|SUPERIORITY|||||||0.4286|||||||Fisher Exact|||||||0.4286
73996095|NCT03079297|147538905|SUPERIORITY|||||||0.999|||||||Fisher Exact|||||||.999
73996096|NCT03079297|147538906|SUPERIORITY|||||||0.9932||||||P-value for Adverse effect burden 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9932
74035994|NCT02491073|147624439|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||TWO_SIDED|90.0|1.12|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.27|1.12|
74035995|NCT02491073|147624439|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||TWO_SIDED|90.0|1.11|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.215|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.27|1.11|
74035996|NCT02491073|147624440|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
74039802|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.19||0.0038|TWO_SIDED|95.0|-0.91|-0.18|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.91|0.0038
74039803|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.17||0.1707|TWO_SIDED|95.0|-0.58|0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.58|0.1707
74039804|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.17||0.1083|TWO_SIDED|95.0|-0.62|0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.62|0.1083
74039805|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.0734|TWO_SIDED|95.0|-0.64|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.64|0.0734
74039806|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.21||0.4603|TWO_SIDED|95.0|-0.56|0.25|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.25|-0.56|0.4603
74090301|NCT00518882|147734132|SUPERIORITY_OR_OTHER||Mean|-1.08|STANDARD_DEVIATION|3.662|<|0.0001||95.0|-1.605|-0.562|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.562|-1.605|<0.0001
74090302|NCT00518882|147734132|SUPERIORITY_OR_OTHER||Mean|-0.99|STANDARD_DEVIATION|3.467||0.0003||95.0|-1.517|-0.458|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.458|-1.517|0.0003
74090303|NCT00518882|147734133|SUPERIORITY_OR_OTHER||Mean|0.26|STANDARD_DEVIATION|4.158||0.3859||95.0|-0.331|0.853|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.853|-0.331|0.3859
74090304|NCT00518882|147734133|SUPERIORITY_OR_OTHER||Mean|-0.37|STANDARD_DEVIATION|3.838||0.2119||95.0|-0.956|0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.214|-0.956|0.2119
73996097|NCT03079297|147538906|SUPERIORITY|||||||0.9932||||||P-value for Adverse effect burden 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9932
73996098|NCT03079297|147538906|SUPERIORITY|||||||0.2242||||||P-value for Adverse effect burden 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2242
73996099|NCT03079297|147538907|SUPERIORITY|||||||0.7282||||||P-value for General fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7282
73996100|NCT03079297|147538907|SUPERIORITY|||||||0.8781||||||P-value for General fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.8781
73996101|NCT03079297|147538907|SUPERIORITY|||||||0.226||||||P-value for General fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.226
73996102|NCT03079297|147538907|SUPERIORITY|||||||0.2158||||||P-value for Mental fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2158
73996103|NCT03079297|147538907|SUPERIORITY|||||||0.0081||||||P-value for Mental fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0081
73996104|NCT03079297|147538907|SUPERIORITY|||||||0.6768||||||P-value for Mental fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.6768
73996105|NCT03079297|147538907|SUPERIORITY|||||||0.0076||||||P-value for Physical fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0076
74090305|NCT00518882|147734134|SUPERIORITY_OR_OTHER||Mean|-0.35|STANDARD_DEVIATION|3.975||0.229||95.0|-0.917|0.2211|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.2211|-0.917|0.2290
73996106|NCT03079297|147538907|SUPERIORITY|||||||0.0858||||||P-value for Physical fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0858
73996107|NCT03079297|147538907|SUPERIORITY|||||||0.2065||||||P-value for Physical fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2065
73996108|NCT03079297|147538907|SUPERIORITY|||||||0.9712||||||P-value for Reduced motivation 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9712
73996109|NCT03079297|147538907|SUPERIORITY|||||||0.7572||||||P-value for Reduced motivation 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7572
73996110|NCT03079297|147538907|SUPERIORITY|||||||0.0588||||||P-value for Reduced motivation 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0588
73996111|NCT03079297|147538907|SUPERIORITY|||||||0.1857||||||P-value for Reduced activity 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.1857
73996112|NCT03079297|147538907|SUPERIORITY|||||||0.9225||||||P-value for Reduced activity 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9225
73996113|NCT03079297|147538907|SUPERIORITY|||||||0.0414||||||P-value for Reduced activity 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0414
73996114|NCT03079297|147538908|SUPERIORITY|||||||0.4603||||||P-value for Psychosocial function 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.4603
73996115|NCT03079297|147538908|SUPERIORITY|||||||0.2521||||||P-value for Psychosocial function 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2521
73996116|NCT03079297|147538908|SUPERIORITY|||||||0.6635||||||P-value for Psychosocial function 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.6635
73996117|NCT03079297|147538909|SUPERIORITY|||||||0.7839||||||P-value for Anhedonia 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7839
73996118|NCT03079297|147538909|SUPERIORITY|||||||0.0248||||||P-value for Anhedonia function 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0248
73996119|NCT03079297|147538909|SUPERIORITY|||||||0.0199||||||P-value for Anhedonia 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0199
73996120|NCT01346072|147538919|SUPERIORITY|||||||0.853|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported||||||0.853
73996121|NCT01346072|147538920|SUPERIORITY|||||||0.035|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported||||||0.035
73996122|NCT03635099|147538921|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
73996123|NCT03635099|147538921|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
73996124|NCT03635099|147538921|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
73996125|NCT03635099|147538921|OTHER||Risk Difference (RD)|30.0||||0.0062|TWO_SIDED|95.0|15.8|44.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||44.2|15.8|0.0062
73996126|NCT03635099|147538921|OTHER||Risk Difference (RD)|25.6|||||TWO_SIDED|95.0|12.5|38.6|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||38.6|12.5|
73996127|NCT03635099|147538921|OTHER||Risk Difference (RD)|23.8|||||TWO_SIDED|95.0|10.9|36.7|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||36.7|10.9|
73996128|NCT03635099|147538921|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Linear model fit.|||||||0.0004
73996129|NCT03635099|147538921|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0012||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Logistic model fit.|Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.||||||0.0012
73996130|NCT03635099|147538921|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0008||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax1 model fit.|Model assumption: 30% of the maximum effect is achieved at 50 mg.||||||0.0008
73996131|NCT03635099|147538921|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0217||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax2 model fit.|Model assumption: 80% of the maximum effect is achieved at 50 mg.||||||0.0217
73996132|NCT03635099|147538921|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Exponential model fit.|Model assumption: 5% of the maximum effect is achieved at 25 mg.||||||0.0004
73996133|NCT03635099|147538922|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
73996134|NCT03635099|147538922|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
73996135|NCT03635099|147538922|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
73996136|NCT03635099|147538922|OTHER||Risk Difference (RD)|27.5||||0.0095|TWO_SIDED|95.0|13.7|41.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||41.3|13.7|0.0095
73996137|NCT03635099|147538922|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0007||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Linear model fit.|||||||0.0007
73996138|NCT03635099|147538922|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0023||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Logistic model fit.|Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.||||||0.0023
74090306|NCT00518882|147734134|SUPERIORITY_OR_OTHER||Mean|-0.95|STANDARD_DEVIATION|3.23||0.0002||95.0|-1.449|-0.459|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.459|-1.449|0.0002
74090307|NCT00518882|147734135|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.73||||0.0124||95.0|0.16|1.31||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.31|0.16|0.0124
74090308|NCT00518882|147734136|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.39||||0.143||95.0|-0.91|0.13||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.13|-0.91|0.1430
74090309|NCT00518882|147734137|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.54||||0.038||95.0|0.03|1.05||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.05|0.03|0.0380
74090310|NCT00518882|147734138|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|2.827||0.77||95.0|-0.344|0.463|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.463|-0.344|0.7700
74090311|NCT00518882|147734138|SUPERIORITY_OR_OTHER||Mean|0.72|STANDARD_DEVIATION|3.27||0.0042||95.0|0.23|1.212|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||1.212|0.230|0.0042
73996139|NCT03635099|147538922|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0018||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax1 model fit.|Model assumption: 30% of the maximum effect is achieved at 50 mg.||||||0.0018
73996140|NCT03635099|147538922|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0386||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax2 model fit.|Model assumption: 80% of the maximum effect is achieved at 50 mg.||||||0.0386
73996141|NCT03635099|147538922|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Exponential model fit.|Model assumption: 5% of the maximum effect is achieved at 25 mg.||||||0.0004
73996142|NCT03635099|147538923|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-11.7|11.7|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.7|-11.7|1.0000
73996143|NCT03635099|147538923|OTHER||Risk Difference (RD)|20.6||||0.054|TWO_SIDED|95.0|3.9|37.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||37.3|3.9|0.0540
73996144|NCT03635099|147538923|OTHER||Risk Difference (RD)|15.5||||0.1167|TWO_SIDED|95.0|-0.4|31.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||31.4|-0.4|0.1167
73996145|NCT03635099|147538923|OTHER||Risk Difference (RD)|45.0||||0.0006|TWO_SIDED|95.0|26.8|63.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||63.2|26.8|0.0006
73996146|NCT03635099|147538923|OTHER||Risk Difference (RD)|45.8|||||TWO_SIDED|95.0|22.0|69.6|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||69.6|22.0|
74090312|NCT00518882|147734139|SUPERIORITY_OR_OTHER||Mean|0.67|STANDARD_DEVIATION|3.041||0.0026||95.0|0.238|1.106|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.106|0.238|0.0026
74091683|NCT00895947|147737045|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||Overall comparison of treatment groups for incidence of ILI|Chi-squared|||||||0.25
74091684|NCT00895947|147737045|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Comparision of ILI incidence in subjects age 50 and older at baseline.|Chi-squared|||||||0.01
73996147|NCT03635099|147538923|OTHER||Risk Difference (RD)|35.2|||||TWO_SIDED|95.0|11.3|59.2|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||59.2|11.3|
73996148|NCT03635099|147538924|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
73996149|NCT03635099|147538924|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
73996150|NCT03635099|147538924|OTHER||Risk Difference (RD)|17.5||||0.0465|TWO_SIDED|95.0|5.7|29.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||29.3|5.7|0.0465
74035997|NCT02491073|147624440|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
74035998|NCT02491073|147624440|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH||1.01|1.00|
74035999|NCT00516269|147624505|SUPERIORITY_OR_OTHER||mean difference in treat versus control|0.42|STANDARD_DEVIATION|3.3||0.54||95.0|||||Wilcoxon signed rank test|||As a crossover study, the potential carryover effect was examined first. The pooled data (the 2-week treatment for each intervention i.e. period 1 \& period 2) was used to assess the treatment effect (A versus B).||||0.54
74036000|NCT01079962|147624506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.701||||0.5943|TWO_SIDED|95.0|-1.89|3.29||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided|||Change in APP at Week 12: p-value was calculated by 2 sided t-test.||3.29|-1.89|0.5943
74090313|NCT00518882|147734139|SUPERIORITY_OR_OTHER||Mean|-0.09|STANDARD_DEVIATION|2.989||0.6845||95.0|-0.541|0.356|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.356|-0.541|0.6845
73996151|NCT03635099|147538924|OTHER||Risk Difference (RD)|9.3|||||TWO_SIDED|95.0|0.6|18.0|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||18.0|0.6|
73996152|NCT03635099|147538924|OTHER||Risk Difference (RD)|4.8|||||TWO_SIDED|95.0|-1.7|11.2|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||11.2|-1.7|
73996153|NCT03635099|147538925|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
73996154|NCT03635099|147538925|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
74036001|NCT01079962|147624507|SUPERIORITY_OR_OTHER|||||||0.8589||95.0|||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.||||0.8589
74036002|NCT01079962|147624507|SUPERIORITY_OR_OTHER|||||||0.2223||95.0|||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.||||0.2223
74036003|NCT01079962|147624507|SUPERIORITY_OR_OTHER|||||||0.2443||95.0|||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.||||0.2443
74036004|NCT01079962|147624507|SUPERIORITY_OR_OTHER|||||||0.1481||95.0|||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.||||0.1481
74036005|NCT01079962|147624507|SUPERIORITY_OR_OTHER|||||||0.4188||95.0|||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.||||0.4188
74036006|NCT01079962|147624507|SUPERIORITY_OR_OTHER|||||||0.1586||95.0|||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.||||0.1586
74036007|NCT01079962|147624508|SUPERIORITY_OR_OTHER|||||||0.2987||95.0|||||t-test, 2 sided|||Change in AIx at Week 4: p-value was calculated by 2 sided t-test.||||0.2987
74036008|NCT01079962|147624508|SUPERIORITY_OR_OTHER|||||||0.6584||95.0|||||t-test, 2 sided|||Change in AIx at Week 12: p-value was calculated by 2 sided t-test.||||0.6584
74036009|NCT01079962|147624509|SUPERIORITY_OR_OTHER|||||||0.2511||95.0|||||t-test, 2 sided|||Change in cfPWV at Week 4: p-value was calculated by 2 sided t-test.||||0.2511
74036010|NCT01079962|147624509|SUPERIORITY_OR_OTHER|||||||0.5007||95.0|||||t-test, 2 sided|||Change in cfPWV at Week 12: p-value was calculated by 2 sided t-test.||||0.5007
74036011|NCT01079962|147624510|SUPERIORITY_OR_OTHER|||||||0.9943||95.0|||||t-test, 2 sided|||Change in heart rate at Week 4: p-value was calculated by 2 sided t-test.||||0.9943
74091685|NCT00895947|147737045|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Comparison of ILI in subjects age \< 50 at baseline|Chi-squared|||||||0.32
74036012|NCT01079962|147624510|SUPERIORITY_OR_OTHER|||||||0.523||95.0|||||t-test, 2 sided|||Change in heart rate at Week 12: p-value was calculated by 2 sided t-test.||||0.5230
74036013|NCT01079962|147624511|SUPERIORITY_OR_OTHER|||||||0.4447||95.0|||||t-test, 2 sided|||||||0.4447
74036014|NCT01079962|147624512|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||t-test, 2 sided|||Change in Total cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.3960
73996155|NCT03635099|147538925|OTHER||Risk Difference (RD)|2.3|||||TWO_SIDED|95.0|-2.2|6.8|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||6.8|-2.2|
73996156|NCT03635099|147538925|OTHER||Risk Difference (RD)|2.4|||||TWO_SIDED|95.0|-2.2|7.0|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||7.0|-2.2|
73996157|NCT03635099|147538926|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
73996158|NCT03635099|147538926|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
73996159|NCT03635099|147538926|OTHER||Risk Difference (RD)|12.8||||0.0942|TWO_SIDED|95.0|2.3|23.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||23.3|2.3|0.0942
73996160|NCT03635099|147538926|OTHER||Risk Difference (RD)|27.5||||0.0095|TWO_SIDED|95.0|13.7|41.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||41.3|13.7|0.0095
73996161|NCT03635099|147538926|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
73996162|NCT03635099|147538926|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
73996163|NCT03635099|147538926|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
73996164|NCT03635099|147538926|OTHER||Risk Difference (RD)|32.5||||0.004|TWO_SIDED|95.0|18.0|47.0|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||47.0|18.0|0.0040
73996165|NCT03635099|147538926|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
73996166|NCT03635099|147538926|OTHER||Risk Difference (RD)|35.0||||0.0025|TWO_SIDED|95.0|20.2|49.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||49.8|20.2|0.0025
73996167|NCT03635099|147538927|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
73996168|NCT03635099|147538927|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
73996169|NCT03635099|147538928|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
73996170|NCT03635099|147538928|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
73996171|NCT03635099|147538928|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
73996172|NCT03635099|147538928|OTHER||Risk Difference (RD)|30.0||||0.0062|TWO_SIDED|95.0|15.8|44.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||44.2|15.8|0.0062
73996173|NCT03635099|147538928|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
73996174|NCT03635099|147538928|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
73996175|NCT03635099|147538928|OTHER||Risk Difference (RD)|25.0||||0.0143|TWO_SIDED|95.0|11.6|38.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||38.4|11.6|0.0143
74091686|NCT00895947|147737045|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Comparison of ILI incidence in subjects vaccinated against seasonal influenza prior to enrollment.|Chi-squared|||||||0.01
73996176|NCT03635099|147538928|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
73996177|NCT03635099|147538928|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
73996178|NCT03635099|147538928|OTHER||Risk Difference (RD)|32.5||||0.004|TWO_SIDED|95.0|18.0|47.0|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||47.0|18.0|0.0040
73996179|NCT03635099|147538929|OTHER||Adjusted mean|0.5|STANDARD_ERROR_OF_MEAN|1.2||0.7008|TWO_SIDED|95.0|-1.9|2.8|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||2.8|-1.9|0.7008
73996180|NCT03635099|147538929|OTHER||Adjusted mean|0.6|STANDARD_ERROR_OF_MEAN|1.2||0.6268|TWO_SIDED|95.0|-1.8|3.0|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||3.0|-1.8|0.6268
74036015|NCT01079962|147624512|SUPERIORITY_OR_OTHER|||||||0.1919||95.0|||||t-test, 2 sided|||Change in LDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.1919
74036016|NCT01079962|147624512|SUPERIORITY_OR_OTHER|||||||0.1896||95.0|||||t-test, 2 sided|||Change in HDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.1896
74036017|NCT01079962|147624513|SUPERIORITY_OR_OTHER|||||||0.9244||95.0|||||t-test, 2 sided|||||||0.9244
73996181|NCT03635099|147538929|OTHER||Adjusted mean|2.7|STANDARD_ERROR_OF_MEAN|1.2||0.0266|TWO_SIDED|95.0|0.3|5.1|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.1|0.3|0.0266
73996182|NCT03635099|147538929|OTHER||Adjusted mean|4.0|STANDARD_ERROR_OF_MEAN|1.2||0.0009|TWO_SIDED|95.0|1.7|6.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||6.3|1.7|0.0009
73996183|NCT03635099|147538929|OTHER||Adjusted mean|3.1|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|0.4|5.8|||||MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.8|0.4|
73996184|NCT03635099|147538929|OTHER||Adjusted mean|3.1|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|0.4|5.8|||||MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.8|0.4|
73996185|NCT03635099|147538930|OTHER||Risk Difference (RD)|2.5||||0.7144|TWO_SIDED|95.0|-10.1|15.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.1|-10.1|0.7144
73996186|NCT03635099|147538930|OTHER||Risk Difference (RD)|2.7||||0.697|TWO_SIDED|95.0|-10.0|15.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.4|-10.0|0.6970
73996187|NCT03635099|147538930|OTHER||Risk Difference (RD)|2.7||||0.697|TWO_SIDED|95.0|-10.0|15.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.4|-10.0|0.6970
73996188|NCT03635099|147538930|OTHER||Risk Difference (RD)|15.0||||0.125|TWO_SIDED|95.0|-0.6|30.6|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||30.6|-0.6|0.1250
73996189|NCT03635099|147538930|OTHER||Risk Difference (RD)|7.9|||||TWO_SIDED|95.0|-20.3|36.1|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||36.1|-20.3|
73996190|NCT03635099|147538930|OTHER||Risk Difference (RD)|6.2|||||TWO_SIDED|95.0|-21.9|34.3|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||34.3|-21.9|
73996191|NCT01038427|147538975|EQUIVALENCE|If the 90% confidence intervals were contained within the interval 80.0% to 125.0%, then the two products were considered to be therapeutically equivalent.|Ratio Test/Ref. Least Squares (LS) Means|106.644|||||TWO_SIDED|90.0|91.86|123.997||||||||123.997|91.860|
73996192|NCT01038427|147538976|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73996193|NCT01038427|147538976|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
73996194|NCT01038427|147538977|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|109.716|||||TWO_SIDED|90.0|93.316|129.159||||||||129.159|93.316|
73996195|NCT01038427|147538978|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73996196|NCT01038427|147538978|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73996197|NCT01038427|147538979|SUPERIORITY|||||||0.2655|||||||Cochran-Mantel-Haenszel|||||||0.2655
73996198|NCT01038427|147538979|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||||||0.0009
73996199|NCT01038427|147538979|SUPERIORITY|||||||0.1093|||||||Cochran-Mantel-Haenszel|||||||0.1093
73996200|NCT01038427|147538980|SUPERIORITY|||||||0.9915|||||||Cochran-Mantel-Haenszel|||||||0.9915
73996201|NCT01038427|147538980|SUPERIORITY|||||||0.0312|||||||Cochran-Mantel-Haenszel|||||||0.0312
73996202|NCT01038427|147538980|SUPERIORITY|||||||0.0487|||||||Cochran-Mantel-Haenszel|||||||0.0487
73996203|NCT04145700|147539025|SUPERIORITY||Posterior Mean Hazard Ratio|2.62||||0.051|TWO_SIDED|80.0|1.19|4.46|||Bayesian hierarchical model|||To conclude success for the intervention, the Bayesian analysis must yield a minimum of 99% posterior probability for PFS Hazard ratio less than 1 \[i.e., Pr(HR \< 1) \> 99%\]. The Bayesian analyses below include posterior mean of Hazard ratio, posterior probabilities instead of p-values, and credible intervals instead of confidence intervals.||4.46|1.19|0.051
73996204|NCT04978493|147539038|OTHER||Difference of adjusted means|1.92|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|95.0|-0.99|4.84|||||(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)|The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.||4.84|-0.99|
74036018|NCT01079962|147624514|SUPERIORITY_OR_OTHER|||||||0.9692||95.0|||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.||||0.9692
74036019|NCT01079962|147624514|SUPERIORITY_OR_OTHER|||||||0.4731||95.0|||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.||||0.4731
74036020|NCT01079962|147624514|SUPERIORITY_OR_OTHER|||||||0.2876||95.0|||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.||||0.2876
74036021|NCT01079962|147624514|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.||||0.0420
74036022|NCT01079962|147624514|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.||||0.5100
74090314|NCT00518882|147734140|SUPERIORITY_OR_OTHER||Mean|0.32|STANDARD_DEVIATION|2.705||0.1041||95.0|-0.066|0.706|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.706|-0.066|0.1041
74090315|NCT00518882|147734140|SUPERIORITY_OR_OTHER||Mean|0.58|STANDARD_DEVIATION|3.114||0.0151||95.0|0.114|1.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.052|0.114|0.0151
74090316|NCT00518882|147734141|SUPERIORITY_OR_OTHER||Mean|-3.31|STANDARD_DEVIATION|3.857|<|0.0001||95.0|-3.861|-2.763|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.763|-3.861|<0.0001
74090317|NCT00518882|147734141|SUPERIORITY_OR_OTHER||Mean|-3.13|STANDARD_DEVIATION|3.56|<|0.0001||95.0|-3.673|-2.589|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.589|-3.673|<0.0001
74090318|NCT00518882|147734142|SUPERIORITY_OR_OTHER||Mean|-1.93|STANDARD_DEVIATION|3.703|<|0.0001||95.0|-2.457|-1.403|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.403|-2.457|<0.0001
74090319|NCT00518882|147734142|SUPERIORITY_OR_OTHER||Mean|-2.17|STANDARD_DEVIATION|3.654|<|0.0001||95.0|-2.731|-1.618|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.618|-2.731|<0.0001
74090320|NCT00518882|147734143|SUPERIORITY_OR_OTHER||Mean|-2.21|STANDARD_DEVIATION|3.752|<|0.0001||95.0|-2.747|-1.676|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.676|-2.747|<0.0001
74090321|NCT00518882|147734143|SUPERIORITY_OR_OTHER||Mean|-2.55|STANDARD_DEVIATION|3.625|<|0.0001||95.0|-3.104|-1.997|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.997|-3.104|<0.0001
74090322|NCT00518882|147734144|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|29.37|||<|0.0001||95.0|16.81|41.93||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||41.93|16.81|<.0001
73996205|NCT04978493|147539039|OTHER||Difference of adjusted means|13.34|STANDARD_ERROR_OF_MEAN|11.32|||TWO_SIDED|95.0|-9.46|36.14|||||(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)|The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.||36.14|-9.46|
73996206|NCT04978493|147539040|OTHER||Unadjusted risk difference|-27.5|||||TWO_SIDED|95.0|-48.42|-2.64|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||-2.64|-48.42|
74090323|NCT00518882|147734145|SUPERIORITY_OR_OTHER||Mean|-18.18|STANDARD_DEVIATION|62.811|<|0.0001||95.0|-26.988|-9.382|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-9.382|-26.988|<0.0001
74090324|NCT00518882|147734145|SUPERIORITY_OR_OTHER||Mean|2.49|STANDARD_DEVIATION|52.997||0.5304||95.0|-5.327|10.307|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||10.307|-5.327|0.5304
73996207|NCT04978493|147539041|OTHER||Unadjusted risk difference|0.67|||||TWO_SIDED|95.0|-20.49|22.12|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||22.12|-20.49|
74090325|NCT00518882|147734146|SUPERIORITY_OR_OTHER||Mean|24.86|STANDARD_DEVIATION|59.326|<|0.0001||95.0|16.348|33.374|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||33.374|16.348|<0.0001
74090326|NCT00518882|147734146|SUPERIORITY_OR_OTHER||Mean|11.13|STANDARD_DEVIATION|87.145||0.092||95.0|-1.835|24.093|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||24.093|-1.835|0.0920
74091687|NCT00895947|147737045|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Comparison of ILI incidence in subjects not vaccinated against seasonal influenza prior to enrollment|Chi-squared|||||||0.45
74090327|NCT00518882|147734147|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.11||||0.0946||95.0|-0.23|0.02||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.02|-0.23|0.0946
74090328|NCT00518882|147734148|SUPERIORITY_OR_OTHER||Mean|0.11|STANDARD_DEVIATION|0.774||0.0513||95.0|-0.001|0.216|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.216|-0.001|0.0513
74090329|NCT00518882|147734148|SUPERIORITY_OR_OTHER||Mean|0.12|STANDARD_DEVIATION|0.804||0.0513||95.0|-0.001|0.233|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.233|-0.001|0.0513
74090330|NCT00518882|147734149|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.859||0.2764||95.0|-0.187|0.054|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.054|-0.187|0.2764
74090331|NCT00518882|147734149|SUPERIORITY_OR_OTHER||Mean|0.09|STANDARD_DEVIATION|0.89||0.1911||95.0|-0.043|0.216|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.216|-0.043|0.1911
73996208|NCT04978493|147539042|OTHER||Unadjusted risk difference|-3.83|||||TWO_SIDED|95.0|-21.14|13.25|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||13.25|-21.14|
73996209|NCT04978493|147539043|OTHER||Unadjusted risk difference|0.33|||||TWO_SIDED|95.0|-17.67|18.78|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||18.78|-17.67|
73996210|NCT04978493|147539044|OTHER||Unadjusted risk difference|-3.33|||||TWO_SIDED|95.0|-24.91|18.85|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||18.85|-24.91|
73996211|NCT04978493|147539045|OTHER||Unadjusted risk difference|-3.5|||||TWO_SIDED|95.0|-23.86|17.34|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||17.34|-23.86|
73996212|NCT04978493|147539046|OTHER||Unadjusted risk difference|-18.5|||||TWO_SIDED|95.0|-42.32|8.89|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||8.89|-42.32|
73996213|NCT04978493|147539047|OTHER||Unadjusted risk difference|0.83|||||TWO_SIDED|95.0|-21.53|23.41|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||23.41|-21.53|
74090332|NCT00518882|147734150|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.04||||0.4412||95.0|-0.15|0.06||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.06|-0.15|0.4412
73996214|NCT04978493|147539048|OTHER||Unadjusted risk difference|-22.17|||||TWO_SIDED|95.0|-45.42|5.19|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||5.19|-45.42|
73996215|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.86||||0.0648|TWO_SIDED|95.0|0.75|0.99||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H11: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 300 mg dose group is greater than or equal to the hazard rate of the placebo group||0.99|0.75|0.0648
73996216|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.85||||0.0241|TWO_SIDED|95.0|0.74|0.98||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H21: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 150 mg dose group is greater than or equal to the hazard rate of the placebo group||0.98|0.74|0.0241
73996217|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.93||||0.1895|TWO_SIDED|95.0|0.8|1.07||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H31: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 50 mg dose group is greater than or equal to the hazard rate of the placebo group.||1.07|0.80|0.1895
73996218|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.572|TWO_SIDED|95.0|0.77|1.16||2-sided unadjusted p-value|Regression, Cox||CV death|||1.16|0.77|0.572
74090333|NCT00518882|147734151|SUPERIORITY_OR_OTHER||Mean|0.03|STANDARD_DEVIATION|0.606||0.4746||95.0|-0.054|0.115|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.115|-0.054|0.4746
73996219|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.296|TWO_SIDED|95.0|0.73|1.1||2-sided unadjusted p-value|Regression, Cox||CV death|||1.10|0.73|0.296
73996220|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.91||||0.369|TWO_SIDED|95.0|0.73|1.12||2-sided unadjusted p-value|Regression, Cox||CV death|||1.12|0.73|0.369
73996221|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.84||||0.067|TWO_SIDED|95.0|0.69|1.01||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||1.01|0.69|0.067
73996222|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.76||||0.006|TWO_SIDED|95.0|0.63|0.92||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||0.92|0.63|0.006
73996223|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.542|TWO_SIDED|95.0|0.78|1.14||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||1.14|0.78|0.542
73996224|NCT01327846|147539054|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.68|1.0|||||MI (non-fatal)|||1.00|0.68|
73996225|NCT01327846|147539054|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.62|0.92|||||MI (non-fatal)|||0.92|0.62|
73996226|NCT01327846|147539054|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.78|1.14|||||MI (non-fatal)|||1.14|0.78|
73996227|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.8||||0.19|TWO_SIDED|95.0|0.56|1.12||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.12|0.56|0.190
73996228|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.912|TWO_SIDED|95.0|0.71|1.35||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.35|0.71|0.912
73996229|NCT01327846|147539054|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.03||||0.871|TWO_SIDED|95.0|0.74|1.43||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.43|0.74|0.871
73996230|NCT01327846|147539054|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.57|1.13|||||Stroke (nonfatal)|||1.13|0.57|
73996231|NCT01327846|147539054|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.72|1.37|||||Stroke (nonfatal)|||1.37|0.72|
73996232|NCT01327846|147539054|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.75|1.45|||||Stroke (nonfatal)|||1.45|0.75|
73996233|NCT01327846|147539057|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.82||||0.0648|TWO_SIDED|95.0|0.72|0.94||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||0.94|0.72|0.0648
73996234|NCT01327846|147539057|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.83||||0.0241|TWO_SIDED|95.0|0.73|0.95||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||0.95|0.73|0.0241
73996235|NCT01327846|147539057|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.1895|TWO_SIDED|95.0|0.79|1.03||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||1.03|0.79|0.1895
73996236|NCT01327846|147539057|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.58||||0.007|TWO_SIDED|95.0|0.39|0.86||2-sided unadjusted p-value|Regression, Cox||unstable angina|||0.86|0.39|0.007
73996237|NCT01327846|147539057|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.64||||0.022|TWO_SIDED|95.0|0.44|0.94||2-sided unadjusted p-value|Regression, Cox||unstable angina|||0.94|0.44|0.022
73996238|NCT01327846|147539057|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.71||||0.086|TWO_SIDED|95.0|0.48|1.05||2-sided unadjusted p-value|Regression, Cox||unstable angina|||1.05|0.48|0.086
73996239|NCT01327846|147539058|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.01||||0.8456|TWO_SIDED|95.0|0.83|1.23||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.23|0.83|0.8456
73996240|NCT01327846|147539058|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.06||||0.8456|TWO_SIDED|95.0|0.87|1.29||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.29|0.87|0.8456
73996241|NCT01327846|147539058|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.6541|TWO_SIDED|95.0|0.8|1.2||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.20|0.80|0.6541
73996242|NCT01327846|147539059|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.028|TWO_SIDED|95.0|0.77|0.99||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||0.99|0.77|0.028
73996243|NCT01327846|147539059|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.011|TWO_SIDED|95.0|0.75|0.96||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||0.96|0.75|0.011
74090334|NCT00518882|147734151|SUPERIORITY_OR_OTHER||Mean|0.08|STANDARD_DEVIATION|0.72||0.1281||95.0|-0.024|0.188|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.188|-0.024|0.1281
74090335|NCT00518882|147734152|SUPERIORITY_OR_OTHER||Mean|-0.3|STANDARD_DEVIATION|0.604|<|0.0001||95.0|-0.39|-0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.214|-0.390|<0.0001
74090336|NCT00518882|147734152|SUPERIORITY_OR_OTHER||Mean|-0.21|STANDARD_DEVIATION|0.647|<|0.0001||95.0|-0.303|-0.11|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.110|-0.303|<0.0001
74091688|NCT00895947|147737045|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Comparison of ILI incidence in male subjects|Chi-squared|||||||0.03
74091689|NCT00895947|147737045|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||Comparison of ILI incidence in female subjects|Chi-squared|||||||0.99
74090337|NCT00518882|147734153|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.07||||0.0277||95.0|-0.13|-0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.01|-0.13|0.0277
74091690|NCT00895947|147737046|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Proportion of subjects reporting any cold/flu symptoms during treatment|Chi-squared|||||||0.16
74091691|NCT00895947|147737046|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects reporting moderate to severe feverishness|Chi-squared|||||||0.03
74091692|NCT00895947|147737046|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Proportion of subjects reporting moderate to severe head congestion|Chi-squared|||||||0.04
74091693|NCT00895947|147737046|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||Proportion of subjects reporting moderate to severe sore throat|Chi-squared|||||||0.07
74091694|NCT00895947|147737047|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to think clearly|Chi-squared|||||||0.39
74091695|NCT00895947|147737047|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to sleep well|Chi-squared|||||||0.15
73996244|NCT01327846|147539059|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.377|TWO_SIDED|95.0|0.83|1.07||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||1.07|0.83|0.377
73996245|NCT01327846|147539060|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.93||||0.406|TWO_SIDED|95.0|0.79|1.1||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.10|0.79|0.406
73996246|NCT01327846|147539060|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.92||||0.329|TWO_SIDED|95.0|0.78|1.09||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.09|0.78|0.329
73996247|NCT01327846|147539060|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.96||||0.597|TWO_SIDED|95.0|0.81|1.13||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.13|0.81|0.597
73996248|NCT01840410|147539071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.94|STANDARD_ERROR_OF_MEAN|1.502|<|0.001|TWO_SIDED|95.0|6.97|12.91|||Mixed Models Analysis|||||12.91|6.97|<0.001
74036023|NCT01079962|147624514|SUPERIORITY_OR_OTHER|||||||0.1207||95.0|||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.||||0.1207
74036024|NCT01079962|147624516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.442||||0.7561||95.0|-2.36|3.24||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided|||||3.24|-2.36|0.7561
74036025|NCT01072539|147624519|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of Infection Sites: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.||||<0.0001
74036026|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0067||||||Statistical significant level: 0.05|Chi-squared|||Geriatrc: \<65 Years Versus (VS) Geriatrc: \>=65 Years||||0.0067
74036027|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0412||||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age categories: \<30 Years, 30 to 39 Years, 40 to 49 Years, 50 to 64 Years, and \>=65 Years.||||0.0412
74036028|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4792||||||Statistical significant level: 0.05|Chi-squared|||Sex: Male VS Sex: Female||||0.4792
74036029|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9669||||||Statistical significant level: 0.05|Chi-squared|||Comparson among Duration of Disease categories: \<3 Months, \>=3 Months and \<6 Months, and \>=6 Months||||0.9669
74036030|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0064||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of infection site: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.||||0.0064
74036031|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Satistical significant level: 0.05|Chi-squared|||Comparison among severity of infection subgroups: Mild, Moderate, and Severe.||||<0.0001
74036032|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History: Yes VS General Medical History: No||||<0.0001
74036033|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Present): Yes VS General Medical History (Present): No||||<0.0001
74036034|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Past): Yes VS General Medical History (Past): No||||0.0006
74036035|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Kidney Disorder: Yes VS Kidney Disorder: No||||<0.0001
74036036|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Liver Disorder: Yes VS Liver Disorder: No||||<0.0001
74036037|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0153||||||Statistical significant level: 0.05|Chi-squared|||Comparison among subgroups of Total Treatment Period of Tygacil: \<7 Days, 7 to 14 Days, and \>14 Days||||0.0153
74036038|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level 0.05|Fisher Exact|||Comparison among subgroups of Mean Daily Dose of Tygacil: \<50 mg, 50 to \<100 mg, 100 to \<200 mg, and \>=200 mg.||||<0.0001
74036039|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0376||||||Statistical significant level: 0.05|Chi-squared|||Past Medication and Therapy: Yes VS Past Medication and Therapy: No||||0.0376
74036040|NCT01072539|147624520|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Concomitant Medications: Yes VS Concomitant Medications: No||||<0.0001
74036041|NCT01008995|147624551|SUPERIORITY_OR_OTHER||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight \[≤ 65kg vs \> 65 kg)\].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. Power calculations were based on two sample size assumptions: 220 (1:1 ratio) and 320 participants (1:1 ratio). Simulation studies evaluated the power to detect a treatment difference between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight \[\<=65 kg vs \> 65 kg). The power was \>99% for both sample size assumptions.||||<0.001
74036042|NCT01008995|147624552|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight \[≤ 65kg vs \> 65 kg)\].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
74036043|NCT01008995|147624553|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs \> 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
74036044|NCT02856269|147624554|OTHER|Wilcoxon rank sum tests, X2 tests, Fisher exact tests, Kolmogorov-Smirnov|Cohen's D value|0.8|||||TWO_SIDED||||||||The Cohen's d is calculated after Box-Cox transformation. Small effect \<= 0.2, Medium effect \[0.3, 0.8\]; Large effect \>0.8|||||
74036045|NCT02020031|147624574|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 3 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
74036046|NCT02020031|147624574|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 30 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
74090338|NCT00518882|147734154|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|0.29||0.003||95.0|0.021|0.102|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.102|0.021|0.0030
74090339|NCT00518882|147734154|SUPERIORITY_OR_OTHER||Mean|0.03|STANDARD_DEVIATION|0.307||0.1452||95.0|-0.012|0.079|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.079|-0.012|0.1452
74036047|NCT02020031|147624574|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 50 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
74036048|NCT02020031|147624574|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 115 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
74036049|NCT02020031|147624574|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 150 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
74036050|NCT02020031|147624574|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 180 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
74036051|NCT03534063|147624579|SUPERIORITY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|Comparisons for opioid consumption and composite pain intensity were performed by analysis of covariance, adjusting for baseline differences in groups||||||.047
74036052|NCT03534063|147624580|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|||||||.638
74036053|NCT01042613|147624588|SUPERIORITY_OR_OTHER||Difference of the Binomial Proportions|0.02||||0.851||95.0|||||Fisher Exact|||||||.851
74036054|NCT01042613|147624589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.105||95.0|||||Wilcoxon (Mann-Whitney)|||||||.105
74036055|NCT01042613|147624590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||.8
74090340|NCT00518882|147734155|SUPERIORITY_OR_OTHER||Mean|0.27|STANDARD_DEVIATION|0.306|<|0.0001||95.0|0.223|0.315|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.315|0.223|<0.0001
74090341|NCT00518882|147734155|SUPERIORITY_OR_OTHER||Mean|0.31|STANDARD_DEVIATION|0.346|<|0.0001||95.0|0.259|0.364|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.364|0.259|<0.0001
74091696|NCT00895947|147737047|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to breathe easily|Chi-squared|||||||0.66
74036056|NCT02338492|147624612|SUPERIORITY|||||||0.615||||||P-value not adjusted for multiple comparisons as the second co-primary endpoint will only be tested if the p-value for VAS improvement is \<0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) model employed, including the baseline VAS score. Missing values will be imputed.||Null hypothesis: Mean improvement in VAS over 90 days \<= 53.8 (i.e. 80% of reference based on historical control data). The study was powered to 80% with 68 evaluable subjects, a standard deviation of 13.3 at each visit, a true mean improvement from baseline VAS across post-baseline visits of 57 and a within-patient correlation of VAS of 0.4. The historical control data comes from 4 selected articles (Gregory et al. 2011, Kim et al. 2011, Deschamps et al. 2012, and Pretell et al. 2010).||||0.615
74036057|NCT02338492|147624614|OTHER||Percentage of Subjects|100.0|||||TWO_SIDED|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications||100|96|
74036058|NCT02338492|147624614|OTHER||Percentage of Subjects|100.0|||||TWO_SIDED|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: No additional surgical interventions of revisions, supplements, fixations or removals||100|96|
74036059|NCT02338492|147624614|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||100|93|
74036060|NCT02338492|147624614|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Safety Success||100|93|
74036061|NCT02338492|147624614|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications||100|93|
74090342|NCT00518882|147734156|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.01||||0.5105||95.0|-0.02|0.04||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.04|-0.02|0.5105
74090343|NCT00518882|147734157|SUPERIORITY_OR_OTHER||Mean|-0.01|STANDARD_DEVIATION|0.15||0.222||95.0|-0.034|0.008|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.008|-0.034|0.2220
74036062|NCT02338492|147624614|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: No additional surgical interventions of revisions, supplements, fixations or removals||100|93|
74036063|NCT02338492|147624614|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||99|90|
74036064|NCT02338492|147624614|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Safety Success||99|90|
74036065|NCT02338492|147624614|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no serious device related complications||99|90|
74090344|NCT00518882|147734157|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.141||0.7923||95.0|-0.018|0.024|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.024|-0.018|0.7923
74090345|NCT00518882|147734158|SUPERIORITY_OR_OTHER||Mean|-0.03|STANDARD_DEVIATION|0.159||0.0254||95.0|-0.05|-0.003|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.003|-0.050|0.0254
74036066|NCT02338492|147624614|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: No additional surgical interventions of revisions, supplements, fixations or removals||100|93|
74036067|NCT02338492|147624614|OTHER||Percentage of Subjects|93.8|||||TWO_SIDED|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||98|86|
74036068|NCT02338492|147624614|OTHER||Percentage of Subjects|92.6|||||TWO_SIDED|95.0|85.0|97.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Safety Success||97|85|
74036069|NCT02338492|147624614|OTHER||Percentage of Subjects|93.8|||||TWO_SIDED|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no serious device related complications||98|86|
74036070|NCT02338492|147624614|OTHER||Percentage of Subjects|95.1|||||TWO_SIDED|95.0|88.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: No additional surgical interventions of revisions, supplements, fixations or removals||99|88|
74036071|NCT02338492|147624614|OTHER||Percentage of Subjects|86.4|||||TWO_SIDED|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||93|77|
74036072|NCT02338492|147624614|OTHER||Percentage of Subjects|86.4|||||TWO_SIDED|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Safety Success||93|77|
74090346|NCT00518882|147734158|SUPERIORITY_OR_OTHER||Mean|-0.02|STANDARD_DEVIATION|0.165||0.2244||95.0|-0.04|0.009|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.009|-0.040|0.2244
74091697|NCT00895947|147737047|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to walk, climb stairs and exercise|Chi-squared|||||||0.48
74036073|NCT02338492|147624614|OTHER||Percentage of Subjects|91.4|||||TWO_SIDED|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no serious device related complications||96|83|
74036074|NCT02338492|147624614|OTHER||Percentage of Subjects|91.4|||||TWO_SIDED|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: No additional surgical interventions of revisions, supplements, fixations or removals||96|83|
74036075|NCT02338492|147624614|OTHER||Percentage of Subjects|82.7|||||TWO_SIDED|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||90|73|
74036076|NCT02338492|147624614|OTHER||Percentage of Subjects|82.7|||||TWO_SIDED|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Safety Success||90|73|
74036077|NCT03607838|147624643|SUPERIORITY||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|3.35||0.0263|TWO_SIDED|95.0|-14.1|-0.9|||Mixed Models Analysis|||||-0.9|-14.1|0.0263
74036078|NCT03607838|147624644|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|3.4||0.0558|TWO_SIDED|95.0|-13.2|0.2||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||0.2|-13.2|0.0558
74036079|NCT03607838|147624645|SUPERIORITY||Mean Difference (Final Values)|-25.8|STANDARD_ERROR_OF_MEAN|15.24||0.092|TWO_SIDED|95.0|-55.7|4.2||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||4.2|-55.7|0.0920
74036080|NCT03607838|147624646|SUPERIORITY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.95||0.0336|TWO_SIDED|95.0|-8.0|-0.3||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||-0.3|-8.0|0.0336
74036081|NCT03546413|147624657|SUPERIORITY||||||<|0.001||||||This is the calculated p-value|Regression, Logistic|||Test for equivalence between the groups||||<0.001
74036082|NCT03546413|147624658|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.055|||||||Regression, Logistic|||Test for equivalence between the groups||||0.055
74036083|NCT03546413|147624659|SUPERIORITY||||||<|0.001||||||This is the calculated p-value|Wilcoxon (Mann-Whitney)|||||||<0.001
74036084|NCT03546413|147624659|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.|||||<|0.001||||||This is the calculated p-value|Regression, Linear|||||||<0.001
74036085|NCT03546413|147624659|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.939|||||||Regression, Linear|||||||0.939
74036086|NCT03546413|147624659|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.002|||||||Regression, Linear|||||||0.002
74036087|NCT03546413|147624660|SUPERIORITY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
74036088|NCT03546413|147624660|SUPERIORITY|A linear regression model was used on the log of peanut skin prick test with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.208|||||||Regression, Linear|||||||0.208
74036089|NCT03546413|147624660|SUPERIORITY|A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.587|||||||Regression, Linear|||||||0.587
74036090|NCT03546413|147624660|SUPERIORITY|A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.268|||||||Regression, Linear|||||||0.268
74036091|NCT03546413|147624661|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||||||0.985
74036092|NCT03546413|147624661|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.371|||||||Regression, Linear|||||||0.371
74036093|NCT03546413|147624661|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.483|||||||Regression, Linear|||||||0.483
74091698|NCT00895947|147737047|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to perform daily activities|Chi-squared|||||||0.26
74036094|NCT03546413|147624661|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.643|||||||Regression, Linear|||||||0.643
74036095|NCT03546413|147624662|SUPERIORITY|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
74036096|NCT03546413|147624662|SUPERIORITY|A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.857|||||||Regression, Linear|||||||0.857
74036097|NCT03546413|147624662|SUPERIORITY|A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.87|||||||Regression, Linear|||||||0.870
74036098|NCT03546413|147624663|SUPERIORITY|||||||0.658|||||||Regression, Logistic|||||||0.658
74036099|NCT03546413|147624663|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.1|||||||Regression, Logistic|||||||0.100
74036100|NCT03546413|147624663|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.502|||||||Regression, Linear|||||||0.502
74036101|NCT03546413|147624663|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.397|||||||Regression, Linear|||||||0.397
74036102|NCT03546413|147624664|SUPERIORITY|||||||0.659|||||||Regression, Logistic|||||||0.659
74091699|NCT00895947|147737047|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work outside the home|Chi-squared|||||||0.25
74091700|NCT00895947|147737047|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work inside the home|Chi-squared|||||||0.20
74036103|NCT03546413|147624664|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.26|||||||Regression, Logistic|||||||0.260
74036104|NCT03546413|147624664|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.075|||||||Regression, Linear|||||||0.075
74036105|NCT03546413|147624664|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.192|||||||Regression, Logistic|||||||0.192
74036106|NCT03546413|147624665|SUPERIORITY|||||||0.729|||||||Regression, Logistic|||||||0.729
74036107|NCT03546413|147624665|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.75|||||||Regression, Logistic|||||||0.750
74036108|NCT03546413|147624665|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.155|||||||Regression, Logistic|||||||0.155
74036109|NCT03546413|147624665|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.458|||||||Regression, Logistic|||||||0.458
74090347|NCT00518882|147734159|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.18||||0.0485||95.0|-0.37|0.0||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.00|-0.37|0.0485
74036110|NCT03546413|147624666|SUPERIORITY|||||||0.33|||||||Regression, Logistic|||||||0.330
74036111|NCT03546413|147624666|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.351|||||||Regression, Logistic|||||||0.351
74090348|NCT00518882|147734160|SUPERIORITY_OR_OTHER||Mean|0.1|STANDARD_DEVIATION|0.82||0.1161||95.0|-0.02|0.21|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.21|-0.02|0.1161
74036112|NCT03546413|147624666|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.502|||||||Regression, Logistic|||||||0.502
74036113|NCT03546413|147624666|SUPERIORITY|||||||0.732||||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.|Regression, Logistic|||||||0.732
74090349|NCT00518882|147734160|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.96||0.7888||95.0|-0.16|0.12|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.12|-0.16|0.7888
74036114|NCT03546413|147624667|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.202|||||||Regression, Logistic|||||||0.202
74090350|NCT00518882|147734161|SUPERIORITY_OR_OTHER||Mean|-0.3|STANDARD_DEVIATION|1.07||0.0003||95.0|-0.43|-0.13|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.13|-0.43|0.0003
74090351|NCT00518882|147734161|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|1.47||0.2078||95.0|-0.35|0.08|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.08|-0.35|0.2078
74036115|NCT03546413|147624667|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in older siblings.|||
74036116|NCT03546413|147624667|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in parents.|||
74036117|NCT03546413|147624668|SUPERIORITY|||||||0.029|||||||Regression, Logistic|||||||0.029
74036118|NCT03546413|147624668|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.489|||||||Regression, Logistic|||||||0.489
74036119|NCT03546413|147624668|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the model was unable to converge due to the low percentage of peanut-related adverse events in older siblings.|||
74036120|NCT04866303|147624672|OTHER|unadjusted logistic regression model|Odds Ratio (OR)|1.79||||0.04|TWO_SIDED|95.0|1.03|2.8|||Regression, Logistic|||Minimum testing kit completion rate of 70% in the passive study arm, and calculated that 400 total subjects would provide us with 90% power to detect an effect size associated with a rate ratio of 1.20, or an absolute difference of 14% (70% in passive, 84% in active). A futility boundary of 60% was identified by Community Advisory Board members as justification to prematurely halt trial enrollment if, after completing 25% of expected enrollment, successful test completion fell below that rate.||2.80|1.03|0.04
74090352|NCT00518882|147734162|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.07||||0.0014||95.0|-0.11|-0.03||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.03|-0.11|0.0014
73996249|NCT04608773|147539138|SUPERIORITY||||||<|0.501|||||||ANCOVA|||Null hypothesis is that there was no difference in change of Dry mouth score between Refresh and Biotene. ANCOVA model was performed by regressing the difference in after-treatment measurement between Refresh and Biotene over the difference of baseline between Refresh and Biotene. The test was performed with a significance level of 0.05 (two- sided)||||<0.501
73996250|NCT04608773|147539139|SUPERIORITY|||||||0.109|||||||ANCOVA|||||||.109
73996251|NCT04608773|147539140|SUPERIORITY|||||||0.107|||||||ANCOVA|||||||.107
73996252|NCT04608773|147539141|SUPERIORITY|||||||0.489|||||||ANCOVA|||||||.489
73996253|NCT04608773|147539142|SUPERIORITY|||||||0.213|||||||ANCOVA|||||||.213
73996254|NCT04608773|147539143|SUPERIORITY|||||||0.486|||||||ANCOVA|||||||.486
73996255|NCT02833077|147539145|SUPERIORITY||Responder Rate Difference|28.85||||0.0019|TWO_SIDED|95.0|11.16|45.6||If the 2-sided p-value is \< 0.05, the responder rate is greater for treatment than for control group, and point estimate of the responder rater for treatment group is greater than 50%, then treatment will be considered superior to control group.|Fisher's exact test|||Superiority of treatment group was established if responder rate at month 6 was statistically greater than that for the control group at month 6 and the observed responder rate at month 6 for the treatment group was greater than 50%.||45.60|11.16|0.0019
73996256|NCT02833077|147539146|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean overall satisfaction score at month 6 visit is statistically greater than that at the baseline for the treatment group.|Two sided paired t-test|||||||<.0001
73996257|NCT00316017|147539149|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to day 28 day between the three groups.||||0.91
73996258|NCT00316017|147539150|SUPERIORITY_OR_OTHER|||||||0.94||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in ARDS-free survival through day 28 between the three groups.||||0.94
73996259|NCT00316017|147539151|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.||||0.73
73996260|NCT00316017|147539152|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients with the Presence of Nosocomial Infection through day 28 between the three groups.||||0.8
73996261|NCT00316017|147539153|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.||||0.69
73996262|NCT00316017|147539154|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of Total fluids given within the first 24 hours between the three groups.||||0.57
73996263|NCT00316017|147539155|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.||||0.66
73996264|NCT00316017|147539156|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the ICU through day 28 between the three groups.||||0.82
73996265|NCT00316017|147539157|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the hospital through day 28 between the three groups.||||0.98
73996266|NCT00316017|147539158|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to hospital discharge between the three groups.||||0.85
73996267|NCT00316017|147539159|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received zero units of PRBC in the first 24 hours between the three groups.||||0.48
74090353|NCT00518882|147734163|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|0.269||0.0018||95.0|0.023|0.098|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.098|0.023|0.0018
74091701|NCT00895947|147737047|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to interact with others|Chi-squared|||||||0.20
74091702|NCT00895947|147737047|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to live personal life|Chi-squared|||||||0.32
74036121|NCT04866303|147624673|OTHER||Odds Ratio (OR)|1.39||||0.18|TWO_SIDED|95.0|0.86|2.26|||Regression, Logistic|||Minimum testing kit completion rate of 70% in the passive study arm, and calculated that 400 total subjects would provide us with 90% power to detect an effect size associated with a rate ratio of 1.20, or an absolute difference of 14% (70% in passive, 84% in active). A futility boundary of 60% was identified by Community Advisory Board members as justification to prematurely halt trial enrollment if, after completing 25% of expected enrollment, successful test completion fell below that rate||2.26|0.86|0.18
74036122|NCT02665364|147624693|SUPERIORITY||arithmetic mean|-30.2802|STANDARD_ERROR_OF_MEAN|5.2588|<|0.0001|TWO_SIDED|95.0|-40.6653|-19.8951|||ANCOVA|||The percent of change from baseline to last available value between W24 and W36 of treatment in the expression of IFN-induced genes was analyzed using an analysis of covariance (ANCOVA) model.||-19.8951|-40.6653|< 0.0001
74036123|NCT02665364|147624694|SUPERIORITY||Odds Ratio (OR)|1.38||||0.34|TWO_SIDED|95.0|0.716|2.657|||Regression, Logistic|||Descriptive statistics for the response to treatment according to BICLA at week 36 were presented by treatment group. The response to treatment according to BICLA was analyzed using a logistic regression with the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.||2.657|0.716|0.34
74036124|NCT02665364|147624695|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6243|TWO_SIDED|95.0|0.602|2.329|||Regression, Logistic|||The SRI-4 response was analyzed using a logistic regression using the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.||2.329|0.602|0.6243
74036125|NCT02665364|147624696|SUPERIORITY|||||||0.0022|||||||Pearson's Chi-squared|||||||0.0022
74036126|NCT02665364|147624697|SUPERIORITY|||||||0.7946|||||||Wilcoxon (Mann-Whitney)|||Baseline to last available value between W24 and W36||||0.7946
74036127|NCT02665364|147624698|SUPERIORITY|||||||0.9224|||||||student - pooled|||||||0.9224
74036128|NCT02665364|147624699|SUPERIORITY|||||||0.3258|||||||student - pooled|||||||0.3258
74036129|NCT02665364|147624700|SUPERIORITY|||||||0.6169|||||||Student - Satterthwaite|||||||0.6169
74036130|NCT02665364|147624701|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0796|TWO_SIDED|95.0|0.932|3.524|||Regression, Logistic|||||3.524|0.932|0.0796
74036131|NCT02665364|147624702|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0762|TWO_SIDED|95.0|0.938|3.574|||Regression, Logistic|||||3.574|0.938|0.0762
74036132|NCT02665364|147624705|SUPERIORITY|||||||0.0097|||||||Student - Satterthwaite|||||||0.0097
74036133|NCT02665364|147624706|SUPERIORITY|||||||0.0425|||||||Pearson's Chi-squared|||||||0.0425
74036134|NCT02665364|147624707|SUPERIORITY|||||||0.0396|||||||Pearson's Chi-squared|||||||0.0396
74036135|NCT03888391|147624708|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|Time: F = 1.72, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.20
74036136|NCT03888391|147624710|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 44.47, df = 1/33||Outcomes fitted via a mixed model with time as a predictor.||||<.0001
74036137|NCT03888391|147624711|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|Time: F = 15.74, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.0004
74036138|NCT03888391|147624712|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|Time: F = .28, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.60
74036139|NCT03888391|147624713|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|Time: F = 1.04, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.32
74036140|NCT03888391|147624714|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|Time: F = 1.27, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.27
74036141|NCT00423735|147624730|SUPERIORITY|||||||0.99|||||||Fisher Exact|2-sided test||||||0.99
74036142|NCT01722487|147624742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.09|0.28|||Log Rank|||||0.28|0.09|<0.0001
74036143|NCT01722487|147624743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.001|TWO_SIDED|95.0|0.05|0.56|||Log Rank|||||0.56|0.05|0.0010
74036144|NCT01722487|147624744|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74036145|NCT01722487|147624745|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74036146|NCT01722487|147624746|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74036147|NCT01722487|147624747|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Chi-squared|||||||.0009
74036148|NCT01722487|147624748|SUPERIORITY_OR_OTHER|||||||0.0054|||||||Chi-squared|||||||.0054
74036149|NCT02232087|147624756|EQUIVALENCE|The potency of the test and reference product was considered equivalent if the 90% CI for the estimate of relative potency was completely contained within the limits of 0.67 to 1.50|Odds Ratio, log|1.0|||>|0.1|TWO_SIDED|90.0|0.67|1.5||test for parallelism of dose response lines|ANOVA||Test is the numerator|The measurement of relative potency was conducted for the pair of doses which met the above criteria and lay on the steepest linear portion of the dose response curve. The log estimate of relative potency was obtained as the ratio of the estimated treatment effect as measured by the difference in the intercepts of the parallel lines divided by the estimate of the common slope for log dose.||1.50|0.67|>0.10
74039807|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.0799|TWO_SIDED|95.0|-0.74|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.74|0.0799
74091703|NCT00895947|147737048|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Proportion of subjects in each group reporting one or more days they felt sick|Chi-squared|||||||0.66
74091704|NCT00895947|147737048|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||Proportion of subjects in each group reporting one or more days they missed work|Chi-squared|||||||0.88
74091705|NCT00895947|147737048|SUPERIORITY_OR_OTHER|||||||1||95.0||||Proportion of subjects in each group reporting one or more days they visited the doctor|Chi-squared|||||||1.0
74091706|NCT00895947|147737048|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||Proportion of subjects in each group reporting one or more days they visited the pharmacy|Chi-squared|||||||0.54
74091707|NCT00895947|147737048|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||Proportion of subjects in each group reporting one or more days they took cold/flu medication|Chi-squared|||||||0.24
74091708|NCT00895947|147737048|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||Proportion of subjects in each group reporting one or more days they skipped a planned activity|Chi-squared|||||||0.89
73996268|NCT00316017|147539160|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in field or ED between the three groups among the patients who received zero units of PRBC.||||<0.01
73996269|NCT00316017|147539161|SUPERIORITY_OR_OTHER||||||<|0.02||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in percent of patients who died within 6 hours of admission to the hospital between the three groups among patients who received zero units of PRBC.||||<0.02
73996270|NCT00316017|147539162|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received zero units of PRBC.||||<0.01
73996271|NCT00316017|147539163|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received 1-9 units PRBC in the first 24 hours between the three groups.||||0.51
73996272|NCT00316017|147539164|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in Field or ED between the three groups among the patients who received 1-9 units of PRBC.||||0.73
73996273|NCT00316017|147539165|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received 1-9 units of PRBC.||||0.83
73996274|NCT00316017|147539166|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received 1-9 units of PRBC.||||0.31
73996275|NCT00316017|147539167|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received greater than 10 units of PRBC in first 24 hours between the three groups.||||0.97
73996276|NCT00316017|147539169|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received greater than 10 units of PRBC.||||0.35
73996277|NCT00316017|147539170|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received greater than 10 units of PRBC.||||0.34
73996278|NCT00225017|147539184|NON_INFERIORITY_OR_EQUIVALENCE|25 subjects per arm will have 80% power to detect a difference between groups in mean FMD change of 2.9%, and 90% power to detect a mean FMD change of 3.4%|Mean Difference (Net)|-0.384|STANDARD_DEVIATION|1.0||0.601|TWO_SIDED|95.0|-2.08|1.312|||Wilcoxon (Mann-Whitney)|||||1.312|-2.080|0.601
73996279|NCT00225017|147539185|SUPERIORITY_OR_OTHER||||||<|0.009||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.009
73996280|NCT00225017|147539186|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.141
73996281|NCT02993406|147539191|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.004|TWO_SIDED|95.0|0.79|0.96|||Log Rank|||||0.96|0.79|0.004
73996282|NCT02993406|147539192|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0058|TWO_SIDED|95.0|0.76|0.96|||Log Rank|||||0.96|0.76|0.0058
73996283|NCT02993406|147539193|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0016|TWO_SIDED|95.0|0.66|0.91|||Log Rank|||||0.91|0.66|0.0016
73996284|NCT02993406|147539194|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0013|TWO_SIDED|95.0|0.72|0.92|||Log Rank|||||0.92|0.72|0.0013
73996285|NCT02993406|147539195|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1593|TWO_SIDED|95.0|0.67|1.07|||Log Rank|||||1.07|0.67|0.1593
73996286|NCT02993406|147539196|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6227|TWO_SIDED|95.0|0.88|1.24|||Log Rank|||||1.24|0.88|0.6227
73996287|NCT02993406|147539197|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6608|TWO_SIDED|95.0|0.9|1.18|||Log Rank|||||1.18|0.90|0.6608
73996288|NCT05262517|147539214|OTHER||Least square (LS) mean difference|-0.15|||||TWO_SIDED|95.0|-1.78|1.48||||||LS means and CIs were estimated by an analysis of covariance (ANCOVA) model, using restricted maximum likelihood (REML) with baseline NRS value as a covariate and treatment group and stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms) as the main effects.||1.48|-1.78|
73996289|NCT05262517|147539215|OTHER||LS mean difference|5.12|||||TWO_SIDED|95.0|-21.35|31.59||||||LS means and CIs were estimated by an analysis of covariance model using REML with baseline NRS value as a covariate and treatment group and stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms) as the main effects.||31.59|-21.35|
73996290|NCT05262517|147539216|OTHER||LS mean difference|0.21|||||TWO_SIDED|95.0|-0.99|1.41||||||LS means, and CIs were based on a generalized linear mixed effect model (GLMEM) that included the baseline value as a covariate and fixed effects for treatment group, stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms; yes or no), scheduled time point, and time point by-treatment group interaction.||1.41|-0.99|
73996291|NCT05262517|147539217|OTHER||Difference in percentage|-5.2|||||TWO_SIDED|95.0|-21.3|10.9||||||Stratified by use of daily medications/ oral devices to reduce the intensity of TMD symptoms at randomization with Mantel-Haenzsel weighting.||10.9|-21.3|
74090354|NCT00518882|147734163|SUPERIORITY_OR_OTHER||Mean|0.01|STANDARD_DEVIATION|0.272||0.5499||95.0|-0.028|0.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.052|-0.028|0.5499
73996292|NCT05262517|147539220|OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-8.7|16.6||||||Stratified by use of daily medications/oral devices to reduce the intensity of TMD symptoms at randomization with Mantel-Haenszel weighting.||16.6|-8.7|
73996293|NCT04325282|147539221|OTHER|||||||0.04||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Within-group analysis of change after active rTMS (post-rTMS compared to pre-rTMS).||||0.04
73996294|NCT04325282|147539221|OTHER|||||||0.46||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Within-group analysis of change after sham rTMS (post-rTMS compared to pre-rTMS).||||0.46
73996295|NCT04325282|147539221|OTHER|||||||0.12||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Between-group analysis of change induced by active rTMS versus sham rTMS||||0.12
73996296|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed-rank test|||Within-group analysis of change in cF-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||<0.0001
73996297|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.69||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.69
73996298|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-iT connectivity induced by active versus sham rTMS.||||<0.0001
73996299|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||<0.0001
73996300|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.43||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.43
73996301|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cM-iT connectivity induced by active versus sham rTMS.||||<0.0001
73996302|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.002||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.002
73996303|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.54||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.54
73996304|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.007||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cM connectivity induced by active versus sham rTMS.||||0.007
73996305|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.002||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.002
74091709|NCT00895947|147737049|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||Proportion of subjects in each group with a confirmed viral respiratory infection|Chi-squared|||||||0.61
73996306|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.32||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.32
73996307|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-iT connectivity induced by active versus sham rTMS.||||0.01
73996308|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.003||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cF connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.003
73996309|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.29||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cF connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.29
73996310|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.02||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cF connectivity induced by active versus sham rTMS.||||0.02
73996311|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.003||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.003
73996312|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.66||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.66
73996313|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.008||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-cT connectivity induced by active versus sham rTMS.||||0.008
73996314|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.005||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.005
73996315|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.87||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.87
74039808|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.21||0.2339|TWO_SIDED|95.0|-0.66|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.66|0.2339
74039809|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.21||0.1199|TWO_SIDED|95.0|-0.73|0.08|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.08|-0.73|0.1199
74039810|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.21||0.384|TWO_SIDED|95.0|-0.6|0.23|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.60|0.3840
74090355|NCT00518882|147734164|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|0.273|<|0.0001||95.0|-0.14|-0.062|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.062|-0.140|<0.0001
74090356|NCT00518882|147734164|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.302||0.0012||95.0|-0.118|-0.03|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.030|-0.118|0.0012
74090357|NCT00518882|147734165|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.02||||0.1119||95.0|-0.05|0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.01|-0.05|0.1119
74090358|NCT00518882|147734166|SUPERIORITY_OR_OTHER||Mean|-0.02|STANDARD_DEVIATION|0.168||0.1342||95.0|-0.041|0.006|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.006|-0.041|0.1342
73996316|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.11||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cT connectivity induced by active versus sham rTMS.||||0.11
73996317|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.012||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.012
73996318|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.46||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.46
73996319|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.02||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-iM connectivity induced by active versus sham rTMS.||||0.02
73996320|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iT-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.01
73996321|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.99||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iT-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.99
73996322|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iT-cT connectivity induced by active versus sham rTMS.||||0.04
73996323|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.01
73996324|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.31||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.31
74090359|NCT00518882|147734166|SUPERIORITY_OR_OTHER||Mean|-0.03|STANDARD_DEVIATION|0.189||0.0344||95.0|-0.057|-0.002|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.002|-0.057|0.0344
74091710|NCT00895947|147737049|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Proportion of subjects in each group with a moderate/severe viral respiratory infection|Chi-squared|||||||0.003
74091711|NCT00895947|147737049|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects in each group with a moderate/severe influenza infection|Chi-squared|||||||0.03
73996325|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.05||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-cT connectivity induced by active versus sham rTMS.||||0.05
73996326|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.03|||||||Wilcoxon signed rank test|The threshold for statistical significance was p \< 0.0076.||Within-group analysis of change in cF-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.03
73996327|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.2||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.20
73996328|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-cM connectivity induced by active versus sham rTMS.||||0.04
73996329|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.05||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.05
73996330|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.59||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.59
73996331|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-iM connectivity induced by active versus sham rTMS.||||0.12
73996332|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.1||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.10
73996333|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.57||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.57
73996334|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.06||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-iT connectivity induced by active versus sham rTMS.||||0.06
73996335|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.12
74036150|NCT02232087|147624757|EQUIVALENCE|The potency of the test and reference product was considered equivalent if the 90% CI for the estimate of relative potency was completely contained within the limits of 0.67 to 1.50|Odds Ratio, log|1.0|||>|0.1|TWO_SIDED|90.0|0.67|1.5||test for parallelism of dose response lines|ANOVA||Test is the numerator|The measurement of relative potency was conducted for the pair of doses which met the above criteria and lay on the steepest linear portion of the dose response curve. The log estimate of relative potency was obtained as the ratio of the estimated treatment effect as measured by the difference in the intercepts of the parallel lines divided by the estimate of the common slope for log dose.||1.50|0.67|>0.10
74036151|NCT02232087|147624758|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.55|TWO_SIDED|95.0|-2.5|1.4||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.4|-2.5|0.55
73996336|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.69||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.69
74036152|NCT02232087|147624758|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|1.0||||0.53|TWO_SIDED|95.0|-2.5|1.3||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.3|-2.5|0.53
74036153|NCT02232087|147624758|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|1.0||||0.011|TWO_SIDED|95.0|-2.5|1.3||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.3|-2.5|0.011
74036154|NCT02232087|147624759|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.26|TWO_SIDED|95.0|-0.03|0.1||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.10|-0.03|0.26
74036155|NCT02232087|147624759|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.06|0.06||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.06|-0.06|0.93
74036156|NCT02232087|147624759|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.48|TWO_SIDED|95.0|-0.04|0.08||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.08|-0.04|0.48
74036157|NCT02232087|147624760|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0||||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||||0.93
74036158|NCT02232087|147624760|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.42|TWO_SIDED|95.0|-0.224|0.093||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.093|-0.224|0.42
73996337|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.14||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cM-cT connectivity induced by active versus sham rTMS.||||0.14
73996338|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.12
73996339|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.6||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.60
73996340|NCT04325282|147539222|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-cM connectivity induced by active versus sham rTMS.||||0.04
74036159|NCT02232087|147624760|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.078|TWO_SIDED|95.0|-0.302|0.016||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.016|-0.302|0.078
73996341|NCT02783027|147539250|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|Two sample t-test on the change in sleep quality from baseline to 4 months.||||||0.76
73996342|NCT02783027|147539251|SUPERIORITY||||||<|0.0001||||||Test for group\*time interaction.|Mixed Models Analysis|||||||<0.0001
73996343|NCT02783027|147539252|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Test for group\*time interaction.||||||<0.0001
74036160|NCT02232087|147624761|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.71|TWO_SIDED|95.0|-3.9|5.7||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||5.7|-3.9|0.71
74091712|NCT00895947|147737049|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects in each group with a moderate/severe viral respiratory infection other than influenza|Chi-squared|||||||0.03
74091713|NCT00895947|147737050|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||Proportion of subjects meeting the definition of acute respiratory illness during treatment|Chi-squared|||||||0.54
73996344|NCT02783027|147539253|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Test for group\*time interaction.||||||<0.0001
73996345|NCT02783027|147539254|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|Two sample t-test for change in Occupational Fatigue Exhaustion Recovery (OFER) inter-shift recovery between groups||||||0.91
73996346|NCT04552899|147539258|SUPERIORITY||Difference in Change from Baseline|-20.83|STANDARD_ERROR_OF_MEAN|34.11||0.54|TWO_SIDED|95.0|-87.94|46.29|||RCRM|Random Coefficient Regression Model (RCRM)||||46.29|-87.94|0.54
73996347|NCT04552899|147539261|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.2512|TWO_SIDED|95.0|0.91|1.47|||Log Rank|||||1.47|0.91|0.2512
73996348|NCT04552899|147539262|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9833|TWO_SIDED|95.0|0.51|1.97|||Log Rank|||||1.97|0.51|0.9833
73996349|NCT04552899|147539265|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.7005|TWO_SIDED|95.0|0.4|1.86|||Log Rank|||||1.86|0.40|0.7005
73996350|NCT03098563|147539282|SUPERIORITY|||||||0.021|||||||ANOVA|||||||.021
73996351|NCT02383940|147539283|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.207||0.1|TWO_SIDED|95.0|-0.76|0.06||Threshold for significance = 0.05|MMRM||Difference is sotagliflozin - placebo|Between-group comparison was based on MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (\<=10%, \>10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.||0.06|-0.76|0.10
73996352|NCT04308590|147539288|EQUIVALENCE|The primary analysis will determine whether there is a difference between treatment groups in terms of change from Baseline to Week 22 in 24-hour average SBP. This was performed using a linear mixed-model-for-repeated-measures (MMRM) analysis using a placebo wash-out multiple imputation for treatment discontinuation and for patients that use rescue medication.|Least squares mean difference|-2.67||||0.416|TWO_SIDED|95.0|-9.096|3.766|||Mixed Models Analysis|||||3.766|-9.096|0.4160
73996353|NCT01401153|147539306|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation based on parallel group design --\> revealed that 68 children are needed to detect a difference of 45ms in the mean reaction time between the groups, with α=.05 and a power of 0.8.||||||0.79|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||Power calculation had been performed.||||0.79
73996354|NCT01401153|147539307|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.07|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.07
73996355|NCT01401153|147539308|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.61|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.61
73996356|NCT01401153|147539309|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been perfomed based on this measure||||||0.03|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.03
74091714|NCT00895947|147737050|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||Proportion of subjects meeting with moderate/severe acute respiratory illness during treatment|Chi-squared|||||||0.06
73996357|NCT01401153|147539310|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.25|||||||Generalized linear models|The fixed statement considered treatment, test day and the interaction between treatment and test day||||||0.25
73996358|NCT01401153|147539311|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.7|||||||Generalized linear models|||||||0.70
73996359|NCT01401153|147539312|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.33|||||||Generalized linear models|||||||0.33
73996360|NCT01401153|147539313|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.63|||||||Generalized linear models|||||||0.63
73996361|NCT01401153|147539314|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.62|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.62
73996362|NCT01401153|147539315|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.11|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.11
73996363|NCT01401153|147539316|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.45|||||||t-test, 2 sided|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.45
73996364|NCT01401153|147539317|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.13
73996365|NCT01401153|147539318|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.68|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.68
73996366|NCT01401153|147539319|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.67|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.67
74036161|NCT02232087|147624761|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-4.7|4.7||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||4.7|-4.7|1.00
74036162|NCT02232087|147624761|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|-2.0||||0.016|TWO_SIDED|95.0|-10.6|-1.1||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||-1.1|-10.6|0.016
74036163|NCT03025217|147624762|OTHER||Cohen's d|0.33||||0.095|TWO_SIDED||||||t-test, 2 sided|||||||.095
74036164|NCT03025217|147624763|OTHER||Cohen's d|0.75||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
73996367|NCT00798434|147539356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.12|-0.97|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline urgency episodes.||Based on a 2-sided t-test (5% significance). Null hypothesis: no difference in mean change in mean micturition-related urgency episodes per 24 hours at Week 12 for the 2 groups. Last observation carried forward (LOCF) method used for statistical analyses of the FAS (change from baseline to Week 12).||-0.97|-2.12|<0.0001
73996368|NCT00798434|147539357|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-14.44|||<|0.0001|TWO_SIDED|95.0|-14.67|-14.25|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and confidence interval (CI)|Week 12 LOCF||-14.25|-14.67|<0.0001
73996369|NCT00798434|147539358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.22||0.0001|TWO_SIDED|95.0|-1.28|-0.42|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline severe urgency episodes||Week 12 LOCF||-0.42|-1.28|0.0001
73996370|NCT00798434|147539359|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0005|TWO_SIDED|95.0|0.0|0.0|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF||0.00|0.00|0.0005
73996371|NCT00798434|147539360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.33|-0.64|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of micturitions||Week 12 LOCF||-0.64|-1.33|<0.0001
73996372|NCT00798434|147539361|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.31|||<|0.0001|TWO_SIDED|95.0|-7.4|-7.19|||2-sided Van Elteren's test|||Week 12 LOCF||-7.19|-7.40|<0.0001
73996373|NCT00798434|147539362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.0026|TWO_SIDED|95.0|-0.4|-0.09|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of night-time micturitions||Week 12 LOCF||-0.09|-0.40|0.0026
73996374|NCT00798434|147539363|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-9.52||||0.0012|TWO_SIDED|95.0|-9.52|-9.09|||2-sided Van Elteren's test|||Week 12 LOCF||-9.09|-9.52|0.0012
73996375|NCT00798434|147539364|SUPERIORITY_OR_OTHER||Hodges-Lehman estimate|0.0||||0.1005|TWO_SIDED|95.0|0.0|0.0||The protocol-defined analysis (ANOVA, parametric) not presented because normality assumptions were not met, instead an alternative analysis (Van-Elteren'ts test, non-parametric) as defined in the statistical analysis plan presented.|Van-Elteren's Test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF||0.00|0.00|0.1005
73996376|NCT00798434|147539365|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0218|TWO_SIDED|95.0|0.0|0.0|||2-sided Van Elteren's test|||Week 12 LOCF||0.00|0.00|0.0218
73996377|NCT00798434|147539366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-6.3|-3.1|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and daily sum rating of USS at baseline||Week 12 LOCF||-3.10|-6.30|<0.0001
73996378|NCT00798434|147539367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.515||||0.1113|TWO_SIDED|95.0|0.909|2.528||Logistic regression determined the odds of improvement versus no improvement in dryness, where improvement was defined as dry at both weeks 8 and 12 relative to baseline incontinence.|Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||LOCF||2.528|0.909|0.1113
73996379|NCT00798434|147539368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.11||0.023|TWO_SIDED|95.0|-0.47|-0.04|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of pads per 24 hours||Incontinence pads at Week 12 LOCF||-0.04|-0.47|0.0230
74091715|NCT00895947|147737050|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects with moderate/severe febrile acute respiratory illness during treatment|Chi-squared|||||||0.03
73996380|NCT00798434|147539368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0909|TWO_SIDED|95.0|-0.12|0.01|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of creams per 24 hours||Creams at Week 12 LOCF||0.01|-0.12|0.0909
73996381|NCT00798434|147539368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.2039|TWO_SIDED|95.0|-0.08|0.02|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of powders per 24 hours||Powder at Week 12 LOCF||0.02|-0.08|0.2039
73996382|NCT00798434|147539369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.096|||<|0.0001|TWO_SIDED|95.0|2.181|4.395|||Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||Week 12 LOCF||4.395|2.181|<0.0001
73996383|NCT00798434|147539372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.506|||<|0.0001|TWO_SIDED|95.0|1.767|3.556||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as a negative change from baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPBC category||Week 12 LOCF||3.556|1.767|<0.0001
73996384|NCT00798434|147539376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.916||||0.0009|TWO_SIDED|95.0|1.305|2.811||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as an increase of 1 or more points in difference of scores relative to baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPUS category||LOCF||2.811|1.305|0.0009
73996385|NCT00798434|147539378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.12|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|-9.65|-4.59|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline symptom/bother score||Week 12 LOCF||-4.59|-9.65|<0.0001
73996386|NCT00798434|147539379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.48|STANDARD_ERROR_OF_MEAN|1.14|<|0.0001|TWO_SIDED|95.0|2.24|6.73|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total health-related quality of life (HRQL) score.||Week 12 LOCF||6.73|2.24|<0.0001
73996387|NCT00798434|147539380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|1.44||0.0002|TWO_SIDED|95.0|2.57|8.22|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Coping Subscale at Week 12; LOCF||8.22|2.57|0.0002
73996388|NCT00798434|147539380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|2.84|7.93|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Concern Subscale at Week 12; LOCF||7.93|2.84|<0.0001
74090360|NCT00518882|147734167|SUPERIORITY_OR_OTHER||Mean|-0.08|STANDARD_DEVIATION|0.176|<|0.0001||95.0|-0.105|-0.056|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.056|-0.105|<0.0001
74090361|NCT00518882|147734167|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.192|<|0.0001||95.0|-0.094|-0.038|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.038|-0.094|<0.0001
74090362|NCT03395639|147734170|OTHER|Difference in adjudicated major or CRNM bleeding rates were assessed.|Annualized rate difference|-0.03|||||TWO_SIDED|95.0|-0.18|0.12||||||||0.12|-0.18|
73996389|NCT00798434|147539380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|STANDARD_ERROR_OF_MEAN|1.38||0.0032|TWO_SIDED|95.0|1.38|6.81|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Sleep Subscale at Week 12; LOCF||6.81|1.38|0.0032
73996390|NCT00798434|147539380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.51|STANDARD_ERROR_OF_MEAN|1.03||0.0152|TWO_SIDED|95.0|0.49|4.53|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Social Subscale at Week 12; LOCF||4.53|0.49|0.0152
73996391|NCT00798434|147539381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.537|||<|0.001|TWO_SIDED|95.0|2.281|5.484||Analysis determined the odds of responding on the OAB-S scale (satisfaction with OAB control) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF||5.484|2.281|<0.001
73996392|NCT00798434|147539382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.881|||<|0.0001|TWO_SIDED|95.0|2.045|4.058||Analysis determined the odds of responding on the OAB-S scale (OAB medication expectation) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF||4.058|2.045|<0.0001
73996393|NCT00798434|147539383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|4.12||0.3163|TWO_SIDED|95.0|-4.13|12.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||General Health Perception; LOCF||12.49|-4.13|0.3163
73996394|NCT00798434|147539383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|8.63||0.4698|TWO_SIDED|95.0|-23.7|11.11|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Incontinence Impact; LOCF||11.11|-23.70|0.4698
73996395|NCT00798434|147539383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|STANDARD_ERROR_OF_MEAN|9.28||0.5321|TWO_SIDED|95.0|-24.58|12.88|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Role Limitations; LOCF||12.88|-24.58|0.5321
73996396|NCT00798434|147539383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|8.39||0.6523|TWO_SIDED|95.0|-20.74|13.12|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Physical Limitations; LOCF||13.12|-20.74|0.6523
73996397|NCT00798434|147539383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|6.8||0.6344|TWO_SIDED|95.0|-10.47|16.99|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Social Limitations; LOCF||16.99|-10.47|0.6344
73996398|NCT00798434|147539383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|STANDARD_ERROR_OF_MEAN|8.38||0.2013|TWO_SIDED|95.0|-28.71|6.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Personal Relationships; LOCF||6.49|-28.71|0.2013
73996399|NCT00798434|147539383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.07|STANDARD_ERROR_OF_MEAN|6.88||0.3831|TWO_SIDED|95.0|-19.96|7.83|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Emotions; LOCF||7.83|-19.96|0.3831
74090363|NCT03395639|147734170|OTHER|Difference in adjudicated major bleeding rates were assessed.|Annualized rate difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
74090364|NCT03395639|147734170|OTHER|Difference in all adjudicated bleeding (major, CRNM, minor) rates were assessed.|Annualized rate difference|0.0|||||TWO_SIDED|95.0|-0.24|0.25||||||||0.25|-0.24|
73996400|NCT00798434|147539383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|6.82||0.5167|TWO_SIDED|95.0|-9.3|18.23|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Sleep/Energy; LOCF||18.23|-9.30|0.5167
73996401|NCT00798434|147539383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.19|STANDARD_ERROR_OF_MEAN|5.12||0.0532|TWO_SIDED|95.0|-20.53|0.15|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Severity of Urinary Symptoms; LOCF||0.15|-20.53|0.0532
74090365|NCT00942331|147734178|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.1707|TWO_SIDED|95.0|0.72|1.06|||Log Rank|Stratified log rank||||1.06|0.72|0.1707
74090366|NCT02696031|147734201|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0197|TWO_SIDED|95.0|1.09|2.7||unadjusted p-value|Regression, Logistic|||week 16||2.70|1.09|0.0197
74090367|NCT02696031|147734201|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0146|TWO_SIDED|95.0|1.12|2.76||unadjusted p-value|Regression, Logistic|||week 16||2.76|1.12|0.0146
74090368|NCT02696031|147734202|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0017|TWO_SIDED|95.0|1.35|3.63||unadjusted p-value|Regression, Logistic|||week 52||3.63|1.35|0.0017
74090369|NCT02696031|147734202|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|1.64|4.36||unadjusted p-value|Regression, Logistic|||week 52||4.36|1.64|<.0001
73996402|NCT00798434|147539384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0016|STANDARD_ERROR_OF_MEAN|0.0125||0.8959|TWO_SIDED|95.0|-0.0229|0.0262|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline single utility score||||0.0262|-0.0229|0.8959
74090370|NCT02696031|147734203|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0108|TWO_SIDED|95.0|1.14|2.74||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.74|1.14|0.0108
74090371|NCT02696031|147734203|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0087|TWO_SIDED|95.0|1.16|2.78||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.78|1.16|0.0087
73996403|NCT03898167|147539393|OTHER||Relative Participation|2.36|||||TWO_SIDED|95.0|1.99|2.8||95% CIs were calculated.||||Bivariable tables, Pearson chi-square and Kruskal-Wallis nonparametric tests were used to compare demographic/health care characteristics by study group. Log binomial regression was used to calculate screening proportion, participation difference, and relative participation (calculated as relative risk), with 95% CIs. Overall participation difference and relative participation for SC and SC with patient navigation vs TR were calculated by combining numerators and denominators from each group.||2.80|1.99|
73996404|NCT05177354|147539396|SUPERIORITY||Proportion|89.3|||<|0.001|ONE_SIDED|97.5|71.8|||"It is hypothesized that the proportion of low-back and leg pain subjects with a reduction in overstimulation sensation during Closed Loop On compared to Closed Loop Off period exceeds a performance goal of 50%.~H0: p ≤ 50% HA: p \> 50%"|Binomial Exact Test||||||71.8|<0.001
73996405|NCT03548220|147539405|SUPERIORITY||||||<|0.0001||||||2-sided p-value|Exact Cochran-Mantel-Haenszel|||||||<0.0001
73996406|NCT03548220|147539406|SUPERIORITY||LS Mean Difference|18.21|||<|0.0001|TWO_SIDED|95.0|12.41|24.01|||Mixed-effect Model Repeated Measure||Standard error = 2.913|||24.01|12.41|<0.0001
73996407|NCT03548220|147539409|SUPERIORITY||LS Mean Difference|-26.26|||<|0.0001|TWO_SIDED|95.0|-37.82|-14.7|||Mixed-effect Model Repeated Measure||Standard error = 5.788|||-14.70|-37.82|<0.0001
73996408|NCT03548220|147539410|SUPERIORITY||LS Mean Difference|-70.81||||0.0027|TWO_SIDED|95.0|-115.88|-25.74|||Mixed-effect Model Repeated Measure||Standard error = 22.488|||-25.74|-115.88|0.0027
73996409|NCT03548220|147539411|SUPERIORITY||LS Mean Difference|0.158||||0.0079|TWO_SIDED|95.0|0.043|0.273|||Mixed-effect Model Repeated Measure||Standard error = 0.0578|||0.273|0.043|0.0079
73996410|NCT03548220|147539412|SUPERIORITY||LS Mean Difference|-0.1011|||<|0.0001|TWO_SIDED|95.0|-0.1391|-0.0632|||Mixed-effect Model Repeated Measure||Standard error = 0.01904|||-0.0632|-0.1391|<0.0001
73996411|NCT03548220|147539413|SUPERIORITY||LS Mean Difference|-3.11||||0.0247|TWO_SIDED|95.0|-5.8|-0.41|||Mixed-effect Model Repeated Measure||Standard error = 1.352|||-0.41|-5.80|0.0247
73996412|NCT03548220|147539414|SUPERIORITY||LS Mean Difference|-3.25||||0.0421|TWO_SIDED|95.0|-6.39|-0.12|||Mixed-effect Model Repeated Measure||Standard error = 1.574|||-0.12|-6.39|0.0421
73996413|NCT03570892|147539448|SUPERIORITY||Unadjusted stratified cox model hazard r|1.07|||=|0.694|TWO_SIDED|95.0|0.82|1.4|||Stratified log-rank test one-sided|||||1.40|0.82|= 0.694
73996414|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|77.4||||||95.0||||||||||||
73996415|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|28.4||||||95.0||||||||||||
74090372|NCT02696031|147734203|SUPERIORITY|week 52|Odds Ratio (OR)|2.16||||0.0016|TWO_SIDED|95.0|1.34|3.49||unadjusted p-value|Regression, Linear||||Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|3.49|1.34|0.0016
73996416|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|5.7||||||95.0||||||||||||
73996417|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|4.9||||||95.0||||||||||||
73996418|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|79.2||||||95.0||||||||||||
73996419|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|23.1||||||95.0||||||||||||
74091716|NCT00895947|147737050|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Proportion of subjects with moderate/severe afebrile acute respiratory illness during treatment|Chi-squared|||||||0.60
73996420|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|3.8||||||95.0||||||||||||
73996421|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|6.1||||||95.0||||||||||||
73996422|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|82.4||||||95.0||||||||||||
73996423|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|23.5||||||95.0||||||||||||
73996424|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|5.9||||||95.0||||||||||||
73996425|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|5.8||||||95.0||||||||||||
73996426|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|76.9||||||95.0||||||||||||
73996427|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|20.0||||||95.0||||||||||||
73996428|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|6.2||||||95.0||||||||||||
73996429|NCT00379288|147539481|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|3.1||||||95.0||||||||||||
73996430|NCT00515671|147539502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8868|TWO_SIDED||||||Mixed Models Analysis|||||||.8868
73996431|NCT00515671|147539503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3328|TWO_SIDED||||||Mixed Models Analysis|||||||.3328
73996432|NCT00288639|147539505|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.72|STANDARD_DEVIATION|55.232||||95.0|-34.16|-11.28|||||Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-11.28|-34.16|
73996433|NCT00288639|147539506|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-17.26|STANDARD_DEVIATION|48.797||||95.0|-27.36|-7.15|||||Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-7.15|-27.36|
73996434|NCT00288639|147539507|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.43|STANDARD_DEVIATION|56.615||||95.0|-34.16|-10.71|||||1-28 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts.Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-10.71|-34.16|
73996435|NCT00288639|147539507|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.83|STANDARD_DEVIATION|57.543||||95.0|-34.74|-10.91|||||29-56 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-10.91|-34.74|
73996436|NCT00288639|147539507|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-27.18|STANDARD_DEVIATION|59.323||||95.0|-39.9|-14.46|||||57-84 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency. .|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-14.46|-39.90|
73996437|NCT00288639|147539507|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-30.75|STANDARD_DEVIATION|58.11||||95.0|-43.44|-18.06|||||85-112 Days. Response ratio=100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-18.06|-43.44|
73996438|NCT00288639|147539507|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-38.75|STANDARD_DEVIATION|59.368||||95.0|-51.79|-25.7|||||113-140 Days. Response ratio=100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-25.70|-51.79|
73996439|NCT00288639|147539507|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-44.24|STANDARD_DEVIATION|62.703||||95.0|-58.47|-30.01|||||\>140 Days. Response ratio= 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-30.01|-58.47|
73996440|NCT00288639|147539508|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|7.19|STANDARD_DEVIATION|84.425||||95.0|-17.6|31.98|||||Simple Partial Seizures. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||31.98|-17.60|
73996441|NCT00288639|147539508|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.24|STANDARD_DEVIATION|68.058||||95.0|-37.8|-6.69|||||Complex Partial Seizures. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.69|-37.80|
73996442|NCT00288639|147539508|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-23.85|STANDARD_DEVIATION|84.313||||95.0|-55.33|7.64|||||Evolved to Generalized. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||7.64|-55.33|
73996443|NCT00288639|147539512|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-24.93|STANDARD_DEVIATION|60.867||||95.0|-43.66|-6.2|||||Seizure freq. ≤3 / 28 d. Resp. ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.20|-43.66|
74090373|NCT02696031|147734203|SUPERIORITY|week 52|Median Difference (Net)|2.61|||<|0.0001|TWO_SIDED|95.0|1.62|4.19||unadjusted p-value|Regression, Linear||||Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|4.19|1.62|<.0001
74090374|NCT02696031|147734204|SUPERIORITY||Odds Ratio (OR)|1.6||||0.026|TWO_SIDED|95.0|1.06|2.43||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.43|1.06|0.0260
74090375|NCT02696031|147734204|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0149|TWO_SIDED|95.0|1.11|2.54||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.54|1.11|0.0149
74090376|NCT02696031|147734205|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0005|TWO_SIDED|95.0|1.43|3.58||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|3.58|1.43|0.0005
74090377|NCT02696031|147734205|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0094|TWO_SIDED|95.0|1.16|2.94||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|2.94|1.16|0.0094
74090378|NCT02696031|147734206|SUPERIORITY||Odds Ratio (OR)|3.8|||<|0.0001|TWO_SIDED|95.0|1.95|7.39||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|7.39|1.95|<.0001
73996444|NCT00288639|147539512|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-20.78|STANDARD_DEVIATION|50.334||||95.0|-35.24|-6.33|||||Seizure freq. \>3 / 28 d. Resp. ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.33|-35.24|
73996445|NCT02385240|147539532|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.034|||||TWO_SIDED|90.0|-7.52|10.72|||Wald's method|||||10.72|-7.52|
73996446|NCT02385240|147539533|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.05|||||TWO_SIDED|90.0|-6.94|11.33|||Wald's method|||||11.33|-6.94|
74090379|NCT02696031|147734206|SUPERIORITY||Odds Ratio (OR)|3.64||||0.0001|TWO_SIDED|95.0|1.87|7.1||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|7.10|1.87|0.0001
73996447|NCT02385240|147539534|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.26|||||TWO_SIDED|90.0|-1.77|15.46|||Wald's method|||||15.46|-1.77|
73996448|NCT01014208|147539535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.333|TWO_SIDED|95.0|0.89|1.42||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-rank test||The Pike estimator was the statistical method used to estimate the hazard ratio.|||1.42|0.89|0.333
73996449|NCT01014208|147539536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4053|TWO_SIDED|95.0|0.56|1.24||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR|||1.24|0.56|0.4053
73996450|NCT01014208|147539536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1167|TWO_SIDED|95.0|0.39|1.1||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR|||1.10|0.39|0.1167
73996451|NCT01014208|147539537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.8209|TWO_SIDED|95.0|0.55|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR|||2.43|0.55|0.8209
73996452|NCT01014208|147539537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6313|TWO_SIDED|95.0|0.62|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR|||2.43|0.62|0.6313
73996453|NCT01014208|147539538|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.346|TWO_SIDED|95.0|0.9|1.36||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.36|0.90|0.346
74090380|NCT02696031|147734207|SUPERIORITY||LS Mean|-0.75|STANDARD_ERROR_OF_MEAN|0.259||0.0041|TWO_SIDED|95.0|-1.26|-0.24||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.24|-1.26|0.0041
74090381|NCT02696031|147734207|SUPERIORITY||LS Mean|-0.64|STANDARD_ERROR_OF_MEAN|0.259||0.0143|TWO_SIDED|95.0|-1.15|-0.13||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.13|-1.15|0.0143
73996454|NCT01014208|147539539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.377|TWO_SIDED|95.0|0.7|1.15||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.15|0.70|0.377
73996455|NCT01014208|147539540|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.57||||0.1161|TWO_SIDED|95.0|0.83|9.5||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel|||||9.50|0.83|0.1161
73996456|NCT01014208|147539541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4481|TWO_SIDED|95.0|0.56|1.27||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||Statistics are presented for Completion rate|||1.27|0.56|0.4481
73996457|NCT01014208|147539542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.978|TWO_SIDED|95.0|-2.11|2.17|||ANCOVA|||||2.170|-2.110|0.978
73996458|NCT01014208|147539543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.129||||0.387|TWO_SIDED|95.0|-1.434|3.691|||ANCOVA|||||3.691|-1.434|0.387
73996459|NCT01014208|147539544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.479|TWO_SIDED|95.0|0.74|1.16||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.16|0.74|0.479
73996460|NCT01014208|147539544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.059|TWO_SIDED|95.0|0.64|1.02||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.02|0.64|0.059
73996461|NCT01014208|147539544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.451|TWO_SIDED|95.0|0.83|1.48||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.48|0.83|0.451
73996462|NCT01014208|147539544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.597|TWO_SIDED|95.0|0.86|1.29||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.29|0.86|0.597
73996463|NCT01014208|147539544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.199|TWO_SIDED|95.0|0.7|1.1||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.10|0.70|0.199
73996464|NCT01014208|147539544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.102|TWO_SIDED|95.0|0.93|1.59||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.59|0.93|0.102
73996465|NCT01014208|147539545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.035|TWO_SIDED|95.0|0.36|1.0||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.00|0.36|0.035
73996466|NCT00527787|147539555|SUPERIORITY_OR_OTHER||proportions|4.1||||0.001|TWO_SIDED|95.0|1.9|7.7|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||7.7|1.9|0.001
73996467|NCT00527787|147539556|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
73996468|NCT00527787|147539557|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
73996469|NCT00527787|147539558|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Cochran-Mantel-Haenszel|||||||0.003
73996470|NCT00527787|147539559|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
73996471|NCT02672852|147539615|OTHER||Adjusted percentage difference|70.8|||<|0.001|TWO_SIDED|95.0|65.7|76.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||76.0|65.7|< 0.001
73996472|NCT02672852|147539616|OTHER||Adjusted percentage difference|76.5|||<|0.001|TWO_SIDED|95.0|70.4|82.5|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||82.5|70.4|< 0.001
73996473|NCT02672852|147539617|OTHER||Adjusted percentage difference|25.9|||<|0.001|TWO_SIDED|95.0|17.3|34.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||34.6|17.3|< 0.001
73996474|NCT02672852|147539618|OTHER||Adjusted percentage difference|80.6|||<|0.001|TWO_SIDED|95.0|74.5|86.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||86.6|74.5|< 0.001
73996475|NCT02672852|147539619|OTHER||Adjusted percentage difference|45.5|||<|0.001|TWO_SIDED|95.0|40.3|50.8|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||50.8|40.3|< 0.001
73876859|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-10.0||||0.606|TWO_SIDED|95.0|-43.8|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||23.8|-43.8|0.606
73996476|NCT02672852|147539620|OTHER||Adjusted percentage difference|44.8|||<|0.001|TWO_SIDED|95.0|39.5|50.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||50.0|39.5|< 0.001
73996477|NCT02672852|147539621|OTHER||Adjusted percentage difference|62.1|||<|0.001|TWO_SIDED|95.0|56.4|67.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||67.9|56.4|< 0.001
73996478|NCT02672852|147539622|OTHER||Adjusted percentage difference|73.9|||<|0.001|TWO_SIDED|95.0|66.0|81.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||81.9|66.0|< 0.001
73996479|NCT02672852|147539623|OTHER||Adjusted percentage difference|21.2|||<|0.001|TWO_SIDED|95.0|13.7|28.7|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||28.7|13.7|< 0.001
73996480|NCT02672852|147539624|OTHER||Adjusted percentage difference|33.1|||<|0.001|TWO_SIDED|95.0|24.0|42.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||42.2|24.0|< 0.001
73996481|NCT02672852|147539625|OTHER||Adjusted percentage difference|33.7|||<|0.001|TWO_SIDED|95.0|23.2|44.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||44.2|23.2|< 0.001
73996482|NCT02175641|147539630|OTHER|Generalized linear mixed-effects models with a logistic link|Odds Ratio (OR)|1.07|||>|0.05|TWO_SIDED|95.0|0.62|1.84|||Regression, Logistic|||||1.84|0.62|>0.05
73996483|NCT02175641|147539631|OTHER|Mixed effect models controlling for study site.|Time by treatment interaction coefficien|0.15|STANDARD_ERROR_OF_MEAN|0.59||0.804|TWO_SIDED||||||Mixed Models Analysis|||||||0.804
73996484|NCT02175641|147539632|OTHER||Time*treatment interaction coefficient|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
73996485|NCT02175641|147539633|OTHER|Mixed effect models controlling for study site.|time*treatment interaction coefficient|-0.34|STANDARD_ERROR_OF_MEAN|0.74||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
73996486|NCT02175641|147539634|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.38|TWO_SIDED||||||Mixed Models Analysis|||||||0.38
73996487|NCT02175641|147539635|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||0.39
73996488|NCT02175641|147539636|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.23|STANDARD_ERROR_OF_MEAN|0.37||0.52|TWO_SIDED||||||Mixed Models Analysis|||||||0.52
73996489|NCT02175641|147539637|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|3.83|STANDARD_ERROR_OF_MEAN|3.28||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
73996490|NCT02574845|147539665|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|101.95|||||TWO_SIDED|90.0|89.49|116.15|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||116.15|89.49|
73996491|NCT02574845|147539665|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|106.09|||||TWO_SIDED|90.0|96.12|117.11|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||117.11|96.12|
74036165|NCT04069156|147624764|NON_INFERIORITY|The primary end point assessing non-inferiority of placebo was considered met if the lower boundary of the one-sided 97.5% confidence limit of the difference in the composite success rate between treatment arms (placebo minus aspirin) was greater than the non-inferiority margin (-10%) by the Farrington-Manning test at 12-months in the principal analysis population.|Risk Difference (RD)|6.0|||<|0.0001|ONE_SIDED|97.5|-1.6||||Farrington-Manning risk difference||||||-1.6|<0.0001
74090382|NCT02696031|147734208|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0001|TWO_SIDED|95.0|1.58|4.07||unadjusted p-value|Regression, Logistic|||week 16|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|4.07|1.58|0.0001
74090383|NCT02696031|147734208|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0002|TWO_SIDED|95.0|1.51|3.89||unadjusted p-value|Regression, Logistic|||week 16|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.89|1.51|0.0002
73876860|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-28.5|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||21.0|-28.5|1.000
73996492|NCT02574845|147539665|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|152.18|||||TWO_SIDED|90.0|135.12|171.41|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||171.41|135.12|
73996493|NCT02574845|147539665|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|106.97|||||TWO_SIDED|90.0|94.34|121.3|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||121.30|94.34|
73996494|NCT02574845|147539665|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|115.92|||||TWO_SIDED|90.0|101.93|131.82|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||131.82|101.93|
73996495|NCT02574845|147539666|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|102.47|||||TWO_SIDED|90.0|87.19|120.42|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||120.42|87.19|
73996496|NCT02574845|147539666|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|106.98|||||TWO_SIDED|90.0|92.54|123.69|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||123.69|92.54|
73996497|NCT02574845|147539666|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|154.07|||||TWO_SIDED|90.0|131.7|180.24|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||180.24|131.70|
73996498|NCT02574845|147539666|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|106.81|||||TWO_SIDED|90.0|91.78|124.3|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||124.30|91.78|
73876861|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-25.0||||0.181|TWO_SIDED|95.0|-59.2|9.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||9.2|-59.2|0.181
73996499|NCT02574845|147539666|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|117.98|||||TWO_SIDED|90.0|98.27|141.65|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||141.65|98.27|
73996500|NCT02574845|147539667|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|101.22|||||TWO_SIDED|90.0|89.23|114.82|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||114.82|89.23|
73996501|NCT02574845|147539667|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|107.26|||||TWO_SIDED|90.0|97.65|117.81|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||117.81|97.65|
73996502|NCT02574845|147539667|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|146.45|||||TWO_SIDED|90.0|135.21|158.62|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||158.62|135.21|
73996503|NCT02574845|147539667|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|105.63|||||TWO_SIDED|90.0|92.2|121.0|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||121.00|92.20|
73996504|NCT02574845|147539667|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|118.1|||||TWO_SIDED|90.0|106.75|130.67|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||130.67|106.75|
74036166|NCT04804033|147624783|OTHER||Difference in least square mean (LSM)|-1.4|||||TWO_SIDED|97.5|-2.72|-0.12|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||-0.12|-2.72|
73996505|NCT04091061|147539679|OTHER|90% Confidence Intervals (CIs) for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.99|||||TWO_SIDED|90.0|83.14|296.44|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference.|||296.44|83.14|
74036167|NCT04804033|147624783|OTHER||Difference in LSM|-0.7|||||TWO_SIDED|97.5|-2.07|0.69|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.69|-2.07|
74036168|NCT04804033|147624784|OTHER||Difference in percentage|16.6|||||TWO_SIDED|97.5|4.4|28.8|||||Stratified by randomization stratum using Mantel-Haenszel risk estimation.|||28.8|4.4|
74036169|NCT04804033|147624784|OTHER||Difference in percentage|6.6|||||TWO_SIDED|97.5|-5.6|18.9|||||Stratified by randomization stratum using Mantel-Haenszel risk estimation.|||18.9|-5.6|
74036170|NCT04804033|147624785|OTHER||Difference in LSM|-1.0|||||TWO_SIDED|97.5|-2.68|0.58|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.58|-2.68|
74036171|NCT04804033|147624785|OTHER||Difference in LSM|-0.4|||||TWO_SIDED|97.5|-2.1|1.31|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||1.31|-2.10|
74036172|NCT04804033|147624786|OTHER||Difference in LSM|-1.8|||||TWO_SIDED|97.5|-3.16|-0.42|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||-0.42|-3.16|
74036173|NCT04804033|147624786|OTHER||Difference in LSM|-1.2|||||TWO_SIDED|97.5|-2.53|0.22|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.22|-2.53|
74036174|NCT04804033|147624787|OTHER||Difference in LSM|-0.8|||||TWO_SIDED|97.5|-1.59|0.05|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.05|-1.59|
74036175|NCT04804033|147624787|OTHER||Difference in LSM|-0.2|||||TWO_SIDED|97.5|-1.06|0.74|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.74|-1.06|
74036176|NCT04804033|147624788|OTHER||Difference in LSM|3.9|||||TWO_SIDED|97.5|-1.5|9.39|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||9.39|-1.50|
74036177|NCT04804033|147624788|OTHER||Difference in LSM|0.1|||||TWO_SIDED|97.5|-5.66|5.86|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||5.86|-5.66|
74036178|NCT04804033|147624789|OTHER||Difference in LSM|-9.0|||||TWO_SIDED|97.5|-18.1|0.19|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||0.19|-18.10|
74036179|NCT04804033|147624789|OTHER||Difference in LSM|-9.3|||||TWO_SIDED|97.5|-18.95|0.41|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||0.41|-18.95|
74036180|NCT00543569|147624805|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|13.6|||||TWO_SIDED|90.0|3.2|23.9|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||23.9|3.2|
74036181|NCT00543569|147624805|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|6.1|||||TWO_SIDED|90.0|-3.6|15.8|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||15.8|-3.6|
74036182|NCT00543569|147624805|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|4.0|||||TWO_SIDED|90.0|-5.3|13.3|||||A positive difference indicated a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||13.3|-5.3|
73996506|NCT04091061|147539679|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|125.58|||||TWO_SIDED|90.0|66.51|237.13|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||237.13|66.51|
74036183|NCT00543569|147624806|SUPERIORITY_OR_OTHER||Difference|-1.4|||||TWO_SIDED|90.0|-6.9|4.1||||||Patient survival at 6 months||4.1|-6.9|
74036184|NCT00543569|147624806|SUPERIORITY_OR_OTHER||Difference|1.1|||||TWO_SIDED|90.0|-3.5|5.8||||||Patient survival at 6 months||5.8|-3.5|
74036185|NCT00543569|147624806|SUPERIORITY_OR_OTHER||Difference|-2.6|||||TWO_SIDED|90.0|-8.4|3.2||||||Patient survival at 6 months||3.2|-8.4|
73996507|NCT04091061|147539679|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|123.75|||||TWO_SIDED|90.0|65.54|233.68|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||233.68|65.54|
73996508|NCT04091061|147539680|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.25|||||TWO_SIDED|90.0|81.07|301.16|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||301.16|81.07|
73996509|NCT04091061|147539680|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|165.66|||||TWO_SIDED|90.0|85.95|319.29|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||319.29|85.95|
73996510|NCT04091061|147539680|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|152.18|||||TWO_SIDED|90.0|78.96|293.32|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||293.32|78.96|
73996511|NCT04091061|147539681|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.0|||||TWO_SIDED|90.0|80.95|300.6|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||300.60|80.95|
73996512|NCT04091061|147539681|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|165.38|||||TWO_SIDED|90.0|85.82|318.67|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||318.67|85.82|
73996513|NCT04091061|147539681|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|152.2|||||TWO_SIDED|90.0|78.99|293.29|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||293.29|78.99|
73996514|NCT00821587|147539686|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||We hypothesize that subjects on CsA are more likely to achieve undetectable viral level in patients receiving antiviral therapy for recurrent HCV after Liver Transplant|Chi-squared|||We hypothesize that subjects on CsA are more likely to achieve undetectable viral levels after liver transplant. Comparisons between the two groups (Undetectable viral level vs. Detectable viral level) were performed with Pearson Chi-square tests or Fisher's exact test for categorical variables, and Mann-Whitney U test for continuous variables.||||<0.05
73996515|NCT01145898|147539701|SUPERIORITY_OR_OTHER|||||||0.6261||95.0|||||ANCOVA|||There will be (as shown) differences in the number of subjects based upon the time of analysis due to patient loss, data of insufficient quality at visit, or change in the drug use during period of study (patient switched off treatment by their doctor) so the number of data points varies throughout the analysis by availability.||||.6261
73876862|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.281
73996516|NCT01145898|147539702|SUPERIORITY_OR_OTHER|||||||0.6081||95.0|||||ANCOVA|||||||.6081
73996517|NCT01145898|147539703|SUPERIORITY_OR_OTHER|||||||0.1822||95.0|||||ANCOVA|||||||.1822
73996518|NCT01145898|147539704|SUPERIORITY_OR_OTHER|||||||0.2383||95.0|||||ANCOVA|||||||.2383
73996519|NCT01145898|147539705|SUPERIORITY_OR_OTHER|||||||0.2383||95.0|||||ANCOVA|||||||.2383
73996520|NCT01145898|147539706|SUPERIORITY_OR_OTHER|||||||0.1564||95.0|||||ANCOVA|||||||.1564
73996521|NCT01145898|147539707|SUPERIORITY_OR_OTHER|||||||0.2265||95.0|||||ANCOVA|||||||.2265
73996522|NCT01145898|147539708|SUPERIORITY_OR_OTHER|||||||0.4645||95.0|||||ANCOVA|||||||.4645
73996523|NCT01145898|147539709|SUPERIORITY_OR_OTHER|||||||0.5998||95.0|||||ANCOVA|||||||.5998
73996524|NCT01145898|147539710|SUPERIORITY_OR_OTHER|||||||0.8119||95.0|||||ANCOVA|||||||.8119
73996525|NCT01145898|147539711|SUPERIORITY_OR_OTHER|||||||0.1319||95.0|||||ANCOVA|||||||.1319
73996526|NCT01145898|147539712|SUPERIORITY_OR_OTHER|||||||0.0199||95.0|||||ANCOVA|||||||.0199
73996527|NCT01145898|147539713|SUPERIORITY_OR_OTHER|||||||0.7597||95.0|||||ANCOVA|||||||.7597
73996528|NCT01145898|147539714|SUPERIORITY_OR_OTHER|||||||0.2528||95.0|||||ANCOVA|||||||.2528
73996529|NCT01712061|147539715|SUPERIORITY_OR_OTHER||Ratio of geometric mean changes|0.92|||||TWO_SIDED|95.0|0.75|1.09|||ANCOVA|Bayesian ANCOVA with covariates for baseline UACR and systolic blood pressure (SBP).||||1.09|0.75|
73996530|NCT02551653|147539736|OTHER||Mean Ratio|0.832|||||TWO_SIDED|95.0|0.682|0.979|||||||Volume of Distribution - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|0.979|0.682|
73996531|NCT02551653|147539736|OTHER||Mean Ratio|1.472|||||TWO_SIDED|95.0|1.113|1.891|||||||Volume of Distribution - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.891|1.113|
73996532|NCT02551653|147539736|OTHER||Mean Ratio|0.958|||||TWO_SIDED|95.0|0.692|1.241|||||||Volume of Distribution - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.241|0.692|
73996533|NCT02551653|147539737|OTHER||Mean Ratio|1.013|||||TWO_SIDED|95.0|0.846|1.189|||||||Mean Standardized Uptake Values - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.189|0.846|
73996534|NCT02551653|147539737|OTHER||Mean Ratio|1.056|||||TWO_SIDED|95.0|0.853|1.269|||||||Mean Standardized Uptake Values - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.269|0.853|
73996535|NCT02551653|147539737|OTHER||Mean Ratio|1.047|||||TWO_SIDED|95.0|0.786|1.34|||||||Mean Standardized Uptake Values - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.340|0.786|
73996536|NCT02683785|147539738|OTHER||Mean Difference (Net)|-0.36||||0.442|TWO_SIDED|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value,Treatment Group,Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used.p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented.|||0.58|-1.31|0.442
73996537|NCT02683785|147539739|OTHER||Mean Difference (Net)|-0.46||||0.046|TWO_SIDED|95.0|-0.9|-0.01||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||-0.01|-0.90|0.046
73996538|NCT02683785|147539739|OTHER||Mean Difference (Net)|-0.38||||0.257|TWO_SIDED|95.0|-1.05|0.29||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||0.29|-1.05|0.257
73996539|NCT02683785|147539739|OTHER||Mean Difference (Net)|-0.5||||0.22|TWO_SIDED|95.0|-1.31|0.31||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented|||0.31|-1.31|0.220
73996540|NCT02683785|147539739|OTHER||Mean Difference (Net)|-0.74||||0.085|TWO_SIDED|95.0|-1.59|0.11||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.11|-1.59|0.085
73996541|NCT02683785|147539739|OTHER||Mean Difference (Net)|-0.36||||0.442|TWO_SIDED|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||0.58|-1.31|0.442
73996542|NCT02683785|147539739|OTHER||Mean Difference (Net)|-0.83||||0.139|TWO_SIDED|95.0|-1.93|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.28|-1.93|0.139
73996543|NCT02683785|147539739|OTHER||Mean Difference (Net)|-0.9||||0.103|TWO_SIDED|95.0|-2.0|0.19||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||0.19|-2.00|0.103
73996544|NCT02683785|147539739|OTHER||Mean Difference (Net)|-0.89||||0.132|TWO_SIDED|95.0|-2.06|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.|||0.28|-2.06|0.132
73996545|NCT02683785|147539740|OTHER||Mean Difference (Net)|-0.45||||0.082|TWO_SIDED|95.0|-0.97|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented.|||0.06|-0.97|0.082
73996546|NCT02683785|147539740|OTHER||Mean Difference (Net)|-0.27||||0.426|TWO_SIDED|95.0|-0.96|0.41||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||0.41|-0.96|0.426
73996547|NCT02683785|147539740|OTHER||Mean Difference (Net)|-0.6||||0.129|TWO_SIDED|95.0|-1.38|0.18||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented|||0.18|-1.38|0.129
73996548|NCT02683785|147539740|OTHER||Mean Difference (Net)|-0.78||||0.067|TWO_SIDED|95.0|-1.63|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented.|||0.06|-1.63|0.067
74036186|NCT00543569|147624806|SUPERIORITY_OR_OTHER||Difference|4.9|||||TWO_SIDED|90.0|-3.1|12.8||||||Patient survival at 12 months||12.8|-3.1|
74036187|NCT00543569|147624806|SUPERIORITY_OR_OTHER||Difference|0.5|||||TWO_SIDED|90.0|-8.3|9.2||||||Patient survival at 12 months||9.2|-8.3|
74036188|NCT00543569|147624806|SUPERIORITY_OR_OTHER||Difference|2.4|||||TWO_SIDED|90.0|-6.0|10.8||||||Patient survival at 12 months||10.8|-6.0|
74036189|NCT00543569|147624807|SUPERIORITY_OR_OTHER||Difference|-2.7|||||TWO_SIDED|90.0|-8.5|3.1||||||Graft survival at 6 months||3.1|-8.5|
74036190|NCT00543569|147624807|SUPERIORITY_OR_OTHER||Difference|-0.2|||||TWO_SIDED|90.0|-5.3|4.9||||||Graft survival at 6 months||4.9|-5.3|
73996549|NCT02683785|147539740|OTHER||Mean Difference (Net)|-0.33||||0.494|TWO_SIDED|95.0|-1.28|0.63||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||0.63|-1.28|0.494
73996550|NCT02683785|147539740|OTHER||Mean Difference (Net)|-0.94||||0.107|TWO_SIDED|95.0|-2.08|0.21||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented.|||0.21|-2.08|0.107
73996551|NCT02683785|147539740|OTHER||Mean Difference (Net)|-0.98||||0.092|TWO_SIDED|95.0|-2.13|0.17||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented.|||0.17|-2.13|0.092
74090384|NCT02696031|147734208|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0056|TWO_SIDED|95.0|1.22|3.24||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.24|1.22|0.0056
74090385|NCT02696031|147734208|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0005|TWO_SIDED|95.0|1.45|3.78||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.78|1.45|0.0005
74036191|NCT00543569|147624807|SUPERIORITY_OR_OTHER||Difference|-3.9|||||TWO_SIDED|90.0|-10.0|2.2||||||Graft survival at 6 months||2.2|-10.0|
74036192|NCT00543569|147624807|SUPERIORITY_OR_OTHER||Difference|3.6|||||TWO_SIDED|90.0|-4.6|11.7||||||Graft survival at 12 months||11.7|-4.6|
74036193|NCT00543569|147624807|SUPERIORITY_OR_OTHER||Difference|-0.9|||||TWO_SIDED|90.0|-9.9|8.1||||||Graft survival at 12 months||8.1|-9.9|
74036194|NCT00543569|147624807|SUPERIORITY_OR_OTHER||Difference|-1.6|||||TWO_SIDED|90.0|-10.6|7.4||||||Graft survival at 12 months||7.4|-10.6|
73876863|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
73996552|NCT02683785|147539740|OTHER||Mean Difference (Net)|-1.01||||0.098|TWO_SIDED|95.0|-2.22|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.|||0.20|-2.22|0.098
74036195|NCT00543569|147624808|SUPERIORITY_OR_OTHER||Difference|13.7|||||TWO_SIDED|90.0|2.8|24.6||||||||24.6|2.8|
74036196|NCT00543569|147624808|SUPERIORITY_OR_OTHER||Difference|4.8|||||TWO_SIDED|90.0|-5.4|15.0||||||||15.0|-5.4|
74036197|NCT00543569|147624808|SUPERIORITY_OR_OTHER||Difference|2.8|||||TWO_SIDED|90.0|-7.1|12.6||||||||12.6|-7.1|
74036198|NCT00543569|147624809|SUPERIORITY_OR_OTHER||Difference|10.6|||||TWO_SIDED|90.0|1.8|19.5||||||BCAR at Month 6||19.5|1.8|
74036199|NCT00543569|147624809|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||BCAR at Month 6||12.3|-3.6|
73996553|NCT02683785|147539745|OTHER||Mean Difference (Net)|-2.8||||0.061|TWO_SIDED|95.0|-5.6|0.1||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 1|||0.1|-5.6|0.061
74036200|NCT00543569|147624809|SUPERIORITY_OR_OTHER||Difference|6.4|||||TWO_SIDED|90.0|-1.7|14.6||||||BCAR at Month 6||14.6|-1.7|
74036201|NCT00543569|147624809|SUPERIORITY_OR_OTHER||Difference|12.0|||||TWO_SIDED|90.0|3.0|21.0||||||BCAR at Month 12||21.0|3.0|
74036202|NCT00543569|147624809|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||BCAR at Month 12||12.3|-3.6|
74036203|NCT00543569|147624809|SUPERIORITY_OR_OTHER||Difference|7.8|||||TWO_SIDED|90.0|-0.6|16.2||||||BCAR at Month 12||16.2|-0.6|
74036204|NCT00543569|147624810|SUPERIORITY_OR_OTHER||Difference|12.2|||||TWO_SIDED|90.0|2.0|22.5||||||T-cell Mediated BCAR at Month 6||22.5|2.0|
74036205|NCT00543569|147624810|SUPERIORITY_OR_OTHER||Difference|6.1|||||TWO_SIDED|90.0|-3.6|15.8||||||T-cell Mediated BCAR at Month 6||15.8|-3.6|
74036206|NCT00543569|147624810|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|90.0|-5.3|13.3||||||T-cell Mediated BCAR at Month 6||13.3|-5.3|
74036207|NCT00543569|147624810|SUPERIORITY_OR_OTHER||Difference|13.6|||||TWO_SIDED|90.0|3.0|24.3||||||T-cell Mediated BCAR at Month 12||24.3|3.0|
74036208|NCT00543569|147624810|SUPERIORITY_OR_OTHER||Difference|4.8|||||TWO_SIDED|90.0|-5.1|14.6||||||T-cell Mediated BCAR at Month 12||14.6|-5.1|
74036209|NCT00543569|147624810|SUPERIORITY_OR_OTHER||Difference|4.1|||||TWO_SIDED|90.0|-5.6|13.8||||||T-cell Mediated BCAR at Month 12||13.8|-5.6|
74036210|NCT00543569|147624811|SUPERIORITY_OR_OTHER||Difference|9.3|||||TWO_SIDED|90.0|0.7|18.0||||||T-cell Mediated BCAR at Month 6||18.0|0.7|
74036211|NCT00543569|147624811|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 6||12.3|-3.6|
74036212|NCT00543569|147624811|SUPERIORITY_OR_OTHER||Difference|6.4|||||TWO_SIDED|90.0|-1.7|14.6||||||T-cell Mediated BCAR at Month 6||14.6|-1.7|
74036213|NCT00543569|147624811|SUPERIORITY_OR_OTHER||Difference|10.7|||||TWO_SIDED|90.0|1.8|19.5||||||T-cell Mediated BCAR at Month 12||19.5|1.8|
74036214|NCT00543569|147624811|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 12||12.3|-3.6|
74036215|NCT00543569|147624811|SUPERIORITY_OR_OTHER||Difference|7.8|||||TWO_SIDED|90.0|-0.6|16.2||||||T-cell Mediated BCAR at Month 12||16.2|-0.6|
74036216|NCT00543569|147624815|SUPERIORITY_OR_OTHER||Difference|14.7|||||TWO_SIDED|90.0|3.8|25.5||||||Efficacy Failure at Month 6||25.5|3.8|
73996554|NCT02683785|147539745|OTHER||Mean Difference (Net)|-2.0||||0.282|TWO_SIDED|95.0|-5.6|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Pain component, Week 2|||1.7|-5.6|0.282
73996555|NCT02683785|147539745|OTHER||Mean Difference (Net)|-3.7||||0.113|TWO_SIDED|95.0|-8.4|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component Week 4|||0.9|-8.4|0.113
73996556|NCT02683785|147539745|OTHER||Mean Difference (Net)|-1.0||||0.695|TWO_SIDED|95.0|-5.9|4.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 6|||4.0|-5.9|0.695
73996557|NCT02683785|147539745|OTHER||Mean Difference (Net)|-3.8||||0.176|TWO_SIDED|95.0|-9.4|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 8|||1.8|-9.4|0.176
73996558|NCT02683785|147539745|OTHER||Mean Difference (Net)|-5.5||||0.041|TWO_SIDED|95.0|-10.8|-0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 10|||-0.2|-10.8|0.041
73996559|NCT02683785|147539745|OTHER||Mean Difference (Net)|-4.7||||0.082|TWO_SIDED|95.0|-10.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 12|||0.6|-10.1|0.082
73996560|NCT02683785|147539745|OTHER||Mean Difference (Net)|-0.2||||0.587|TWO_SIDED|95.0|-1.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 1|||0.6|-1.1|0.587
73996561|NCT02683785|147539745|OTHER||Mean Difference (Net)|-0.4||||0.457|TWO_SIDED|95.0|-1.3|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 2|||0.6|-1.3|0.457
73996562|NCT02683785|147539745|OTHER||Mean Difference (Net)|-0.6||||0.298|TWO_SIDED|95.0|-1.8|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 4|||0.6|-1.8|0.298
73996563|NCT02683785|147539745|OTHER||Mean Difference (Net)|-0.2||||0.726|TWO_SIDED|95.0|-1.3|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 6|||0.9|-1.3|0.726
73996564|NCT02683785|147539745|OTHER||Mean Difference (Net)|-0.7||||0.213|TWO_SIDED|95.0|-1.9|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 8|||0.4|-1.9|0.213
73996565|NCT02683785|147539745|OTHER||Mean Difference (Net)|-0.6||||0.331|TWO_SIDED|95.0|-1.9|0.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 10|||0.7|-1.9|0.331
73996566|NCT02683785|147539745|OTHER||Mean Difference (Net)|-0.8||||0.248|TWO_SIDED|95.0|-2.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 12|||0.6|-2.1|0.248
74036217|NCT00543569|147624815|SUPERIORITY_OR_OTHER||Difference|7.5|||||TWO_SIDED|90.0|-2.9|17.8||||||Efficacy Failure at Month 6||17.8|-2.9|
74036218|NCT00543569|147624815|SUPERIORITY_OR_OTHER||Difference|7.9|||||TWO_SIDED|90.0|-2.4|18.2||||||Efficacy Failure at Month 6||18.2|-2.4|
73996567|NCT02683785|147539745|OTHER||Mean Difference (Net)|-2.9||||0.35|TWO_SIDED|95.0|-9.0|3.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 1|||3.3|-9.0|0.350
73996568|NCT02683785|147539745|OTHER||Mean Difference (Net)|-3.0||||0.383|TWO_SIDED|95.0|-9.8|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 2|||3.8|-9.8|0.383
73996569|NCT02683785|147539745|OTHER||Mean Difference (Net)|-4.8||||0.271|TWO_SIDED|95.0|-13.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 4|||3.9|-13.5|0.271
74036219|NCT00543569|147624815|SUPERIORITY_OR_OTHER||Difference|8.4|||||TWO_SIDED|90.0|-3.5|20.4||||||Efficacy Failure at Month12||20.4|-3.5|
73876864|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-25.0||||0.231|TWO_SIDED|95.0|-61.3|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||11.3|-61.3|0.231
73996570|NCT02683785|147539745|OTHER||Mean Difference (Net)|-2.7||||0.565|TWO_SIDED|95.0|-12.1|6.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 6|||6.7|-12.1|0.565
73996571|NCT02683785|147539745|OTHER||Mean Difference (Net)|-4.9||||0.343|TWO_SIDED|95.0|-15.2|5.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 8|||5.4|-15.2|0.343
73996572|NCT02683785|147539745|OTHER||Mean Difference (Net)|-6.2||||0.266|TWO_SIDED|95.0|-17.3|4.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 10|||4.9|-17.3|0.266
73996573|NCT02683785|147539745|OTHER||Mean Difference (Net)|-8.2||||0.136|TWO_SIDED|95.0|-19.1|2.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 12|||2.7|-19.1|0.136
73996574|NCT02683785|147539745|OTHER||Mean Difference (Net)|-5.5||||0.23|TWO_SIDED|95.0|-14.5|3.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 1|||3.6|-14.5|0.230
73996575|NCT02683785|147539745|OTHER||Mean Difference (Net)|-4.6||||0.381|TWO_SIDED|95.0|-15.2|5.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 2|||5.9|-15.2|0.381
73996576|NCT02683785|147539745|OTHER||Mean Difference (Net)|-8.7||||0.207|TWO_SIDED|95.0|-22.4|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 4|||5.0|-22.4|0.207
73996577|NCT02683785|147539745|OTHER||Mean Difference (Net)|-3.4||||0.648|TWO_SIDED|95.0|-18.4|11.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 6|||11.6|-18.4|0.648
74036220|NCT00543569|147624815|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|90.0|-7.8|15.8||||||Efficacy Failure at Month 12||15.8|-7.8|
74036221|NCT00543569|147624815|SUPERIORITY_OR_OTHER||Difference|4.2|||||TWO_SIDED|90.0|-7.5|15.9||||||Efficacy Failure at Month12||15.9|-7.5|
73996578|NCT02683785|147539745|OTHER||Mean Difference (Net)|-9.0||||0.278|TWO_SIDED|95.0|-25.4|7.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 8|||7.5|-25.4|0.278
73996579|NCT02683785|147539745|OTHER||Mean Difference (Net)|-12.1||||0.16|TWO_SIDED|95.0|-29.1|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 10|||5.0|-29.1|0.160
74036222|NCT00543569|147624816|SUPERIORITY_OR_OTHER||Difference|10.7|||||TWO_SIDED|90.0|0.9|20.4||||||Efficacy Failure at Month 6||20.4|0.9|
73996580|NCT02683785|147539745|OTHER||Mean Difference (Net)|-13.3||||0.127|TWO_SIDED|95.0|-30.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 12|||3.9|-30.5|0.127
74036223|NCT00543569|147624816|SUPERIORITY_OR_OTHER||Difference|4.6|||||TWO_SIDED|90.0|-4.5|13.7||||||Efficacy Failure at Month 6||13.7|-4.5|
74036224|NCT00543569|147624816|SUPERIORITY_OR_OTHER||Difference|9.1|||||TWO_SIDED|90.0|-0.4|18.7||||||Efficacy Failure at Month 6||18.7|-0.4|
74036225|NCT00543569|147624816|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|90.0|-4.0|18.0||||||Efficacy Failure at Month 12||18.0|-4.0|
74036226|NCT00543569|147624816|SUPERIORITY_OR_OTHER||Difference|2.3|||||TWO_SIDED|90.0|-8.3|13.0||||||Efficacy Failure at Month 12||13.0|-8.3|
73996581|NCT02683785|147539746|OTHER||Mean Difference (Net)|0.0||||0.957|TWO_SIDED|95.0|-1.9|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||1.8|-1.9|0.957
73996582|NCT02683785|147539746|OTHER||Mean Difference (Net)|0.3||||0.775|TWO_SIDED|95.0|-2.1|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||2.8|-2.1|0.775
74036227|NCT00543569|147624816|SUPERIORITY_OR_OTHER||Difference|6.7|||||TWO_SIDED|90.0|-4.2|17.6||||||Efficacy Failure at Month 12||17.6|-4.2|
73996583|NCT02683785|147539746|OTHER||Mean Difference (Net)|-0.5||||0.624|TWO_SIDED|95.0|-2.7|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||1.7|-2.7|0.624
73996584|NCT02683785|147539746|OTHER||Mean Difference (Net)|1.4||||0.243|TWO_SIDED|95.0|-1.0|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||3.8|-1.0|0.243
73996585|NCT02683785|147539746|OTHER||Mean Difference (Net)|0.2||||0.875|TWO_SIDED|95.0|-2.5|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||2.9|-2.5|0.875
73996586|NCT02683785|147539746|OTHER||Mean Difference (Net)|-0.3||||0.848|TWO_SIDED|95.0|-3.4|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||2.8|-3.4|0.848
73996587|NCT02683785|147539746|OTHER||Mean Difference (Net)|-0.2||||0.883|TWO_SIDED|95.0|-2.8|2.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||2.4|-2.8|0.883
73996588|NCT02683785|147539747|OTHER||Mean Difference (Net)|-1.2||||0.463|TWO_SIDED|95.0|-4.4|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||2.0|-4.4|0.463
73996589|NCT02683785|147539747|OTHER||Mean Difference (Net)|-0.4||||0.809|TWO_SIDED|95.0|-3.7|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||2.9|-3.7|0.809
73996590|NCT02683785|147539747|OTHER||Mean Difference (Net)|-1.9||||0.324|TWO_SIDED|95.0|-5.8|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||2.0|-5.8|0.324
73996591|NCT02683785|147539747|OTHER||Mean Difference (Net)|-0.5||||0.783|TWO_SIDED|95.0|-4.2|3.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||3.2|-4.2|0.783
73996592|NCT02683785|147539747|OTHER||Mean Difference (Net)|-1.4||||0.464|TWO_SIDED|95.0|-5.4|2.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||2.5|-5.4|0.464
73996593|NCT02683785|147539747|OTHER||Mean Difference (Net)|-0.7||||0.736|TWO_SIDED|95.0|-4.9|3.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||3.5|-4.9|0.736
73996594|NCT02683785|147539747|OTHER||Mean Difference (Net)|-0.5||||0.806|TWO_SIDED|95.0|-4.8|3.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||3.7|-4.8|0.806
73996595|NCT02683785|147539748|OTHER||Mean Difference (Net)|0.3||||0.586|TWO_SIDED|95.0|-0.9|1.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||1.6|-0.9|0.586
73996596|NCT02683785|147539748|OTHER||Mean Difference (Net)|-0.5||||0.416|TWO_SIDED|95.0|-1.9|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.8|-1.9|0.416
73996597|NCT02683785|147539748|OTHER||Mean Difference (Net)|-1.2||||0.12|TWO_SIDED|95.0|-2.8|0.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.3|-2.8|0.120
74036228|NCT00543569|147624826|SUPERIORITY_OR_OTHER||Difference|11.1|||||TWO_SIDED|90.0|-1.1|23.3||||||Treatment Failure at Month 6||23.3|-1.1|
74036229|NCT00543569|147624826|SUPERIORITY_OR_OTHER||Difference|11.8|||||TWO_SIDED|90.0|-0.7|24.2||||||Treatment Failure at Month 6||24.2|-0.7|
74036230|NCT00543569|147624826|SUPERIORITY_OR_OTHER||Difference|2.9|||||TWO_SIDED|90.0|-8.9|14.7||||||Treatment Failure at Month 6||14.7|-8.9|
74036231|NCT00543569|147624826|SUPERIORITY_OR_OTHER||Difference|10.0|||||TWO_SIDED|90.0|-2.9|22.8||||||Treatment Failure at Month 12||22.8|-2.9|
74036232|NCT00543569|147624826|SUPERIORITY_OR_OTHER||Difference|9.7|||||TWO_SIDED|90.0|-3.3|22.8||||||Treatment Failure at Month 12||22.8|-3.3|
73996598|NCT02683785|147539748|OTHER||Mean Difference (Net)|-0.3||||0.687|TWO_SIDED|95.0|-2.1|1.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||1.4|-2.1|0.687
73996599|NCT02683785|147539749|OTHER||Mean Difference (Net)|-0.2||||0.651|TWO_SIDED|95.0|-1.3|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented.|||0.8|-1.3|0.651
73996600|NCT02683785|147539749|OTHER||Mean Difference (Net)|-0.7||||0.271|TWO_SIDED|95.0|-1.9|0.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.5|-1.9|0.271
73996601|NCT02683785|147539749|OTHER||Mean Difference (Net)|-0.9||||0.186|TWO_SIDED|95.0|-2.2|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.4|-2.2|0.186
73996602|NCT02683785|147539749|OTHER||Mean Difference (Net)|-1.1||||0.109|TWO_SIDED|95.0|-2.4|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||0.2|-2.4|0.109
73996603|NCT02278484|147539762|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73996604|NCT02233803|147539807|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority (NI) is demonstrated as the lower limit of CI for the difference is greater than the pre-specified NI margin of -1.25ML. The lower limit of the 95% CI for the treatment difference (NEUMOTEROL 400 -Symbicort Forte) was greater than the pre-specified non-inferiority margin of -1.25 mL.|Difference of LS means|0.044|||||TWO_SIDED|95.0|-0.008|0.096||||||Sample size calculations are based on the primary efficacy endpoint (change from baseline in trough FEV1 at day 29). Assuming a within-subject standard deviation of 210 mL, 168 completed subjects are required to demonstrate the non-inferiority of BFF 400/12 mcg SINGLE CAPSULE INHALER and BFF 320/9 mcg TURBUHALER BID, assuming a true difference of -50 mL with 90% power and a 2.5% one-sided significance level. The pre-specified NI margin is set at -1.25mL.||0.096|-0.008|
73996605|NCT02233803|147539808|SUPERIORITY_OR_OTHER||Difference of LS means|0.98|||||TWO_SIDED|95.0|0.576|1.384||||||||1.384|0.576|
74090386|NCT02696031|147734209|SUPERIORITY||LS Mean of treatment difference|-0.89|STANDARD_ERROR_OF_MEAN|0.256||0.0006|TWO_SIDED|95.0|-1.39|-0.38||unadjusted p-value|mixed model repeated measures (MMRM)|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.38|-1.39|0.0006
73996606|NCT02233803|147539809|SUPERIORITY_OR_OTHER||Difference of LS means|0.6|||||TWO_SIDED|95.0|0.1|1.1||||||||1.1|0.1|
73996607|NCT03846453|147539810|SUPERIORITY||Least Squares (LS) Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.064||0.1871|TWO_SIDED|95.0|-0.04|0.21||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.21|-0.04|0.1871
73996608|NCT03846453|147539811|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.5549|TWO_SIDED|95.0|-0.12|0.23|||ANCOVA|P-value calculated using a model with treatment, baseline score, and site as covariates.||||0.23|-0.12|0.5549
73996609|NCT00368927|147539918|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Fisher Exact|||With a sample size of 60 evaluable participants per intervention arm, we would have 90% power to detect a bronchial dysplasia response rate of 54% and 82% power to detect a bronchial dysplasia response rate of\> 51% among participants assigned to receive active sulindac (2-sided chi-square test with continuity correction; alpha=0.05).||||0.85
73996610|NCT00368927|147539919|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||A sample size of 60 participants per intervention arm would provide 90% power and 80% power to detect effect sizes of 60% and 52%, respectively, using a two-sample t-test(alpha=0.05).||||0.63
73996611|NCT03578887|147539971|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73996612|NCT03578887|147539972|SUPERIORITY|||||||0.85|||||||ANOVA|||||||0.85
73996613|NCT05718466|147539980|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
73996614|NCT05718466|147539981|SUPERIORITY|||||||0.001|||||||Log Rank|||||||0.001
73996615|NCT00918879|147540038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.139||0.0011||95.0|-0.73|-0.18|||ANCOVA|\* adjusted for baseline HbA1c||||-0.18|-0.73|0.0011
73996616|NCT00918879|147540039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.19|STANDARD_ERROR_OF_MEAN|5.438||0.0623||95.0|-20.91|0.53|||ANCOVA|\* Adjusted for baseline FPG||||0.53|-20.91|0.0623
73996617|NCT00918879|147540040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.302||0.0623||95.0|-1.17|0.02|||ANCOVA|\* Adjusted for baseline FPG||||0.02|-1.17|0.0623
73996618|NCT00918879|147540041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.8||||||95.0|-1.7|19.3|||Fisher Exact|||||19.3|-1.7|
73996619|NCT01008553|147540043|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Log Rank|||||||0.0003
73996620|NCT01008410|147540069|SUPERIORITY|||||||0.0324||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).||||0.0324
73996621|NCT05602727|147540108|SUPERIORITY|Difference in LS Means (MK-1942 - Placebo)|LS Mean Difference|2.1||||0.186|TWO_SIDED|97.5|-1.6|5.8|||Longitudinal ANCOVA|||||5.8|-1.6|0.186
73996622|NCT05602727|147540108|SUPERIORITY|Difference in LS Means (MK-1942 - Placebo)|LS Mean Difference|-1.4||||0.4|TWO_SIDED|97.5|-5.2|2.4|||Longitudinal ANCOVA|||||2.4|-5.2|0.400
73996623|NCT05602727|147540112|SUPERIORITY|Difference in LS Means|LS Mean Difference|-2.9||||0.196|TWO_SIDED|97.5|-8.0|2.2|||Longitudinal ANCOVA|||||2.2|-8.0|0.196
73996624|NCT05602727|147540112|SUPERIORITY|Difference in LS Means|LS Mean Difference|-4.2||||0.081|TWO_SIDED|97.5|-9.6|1.3|||Longitudinal ANCOVA|||||1.3|-9.6|0.081
73996625|NCT02187159|147540113|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.183||0.0008|TWO_SIDED|95.0|-0.97|-0.25|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.25|-0.97|0.0008
73996626|NCT02187159|147540113|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.183||0.0392|TWO_SIDED|95.0|-0.74|-0.02|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.02|-0.74|0.0392
73996627|NCT02187159|147540113|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.183||0.2192|TWO_SIDED|95.0|-0.58|0.13|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.13|-0.58|0.2192
73996628|NCT02187159|147540113|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.184||0.2095|TWO_SIDED|95.0|-0.13|0.59|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.59|-0.13|0.2095
73996629|NCT02187159|147540113|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.185||0.0381|TWO_SIDED|95.0|0.02|0.75|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.75|0.02|0.0381
73996630|NCT02187159|147540115|SUPERIORITY||Mean Difference (Final Values)|-7.67|STANDARD_ERROR_OF_MEAN|1.598|<|0.0001|TWO_SIDED|95.0|-10.71|-4.44|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-4.44|-10.71|<0.0001
73996631|NCT02187159|147540115|SUPERIORITY||Mean Difference (Final Values)|-3.52|STANDARD_ERROR_OF_MEAN|1.613||0.0289|TWO_SIDED|95.0|-6.68|-0.36|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.36|-6.68|0.0289
73996632|NCT02187159|147540115|SUPERIORITY||Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|1.625||0.1148|TWO_SIDED|95.0|-5.75|0.62|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.62|-5.75|0.1148
73876865|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|37.5||||0.099|TWO_SIDED|95.0|5.8|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||69.2|5.8|0.099
74036233|NCT00543569|147624826|SUPERIORITY_OR_OTHER||Difference|-0.8|||||TWO_SIDED|90.0|-13.3|11.7||||||Treatment Failure at Month 12||11.7|-13.3|
73996633|NCT02187159|147540115|SUPERIORITY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|1.621||0.0125|TWO_SIDED|95.0|0.87|7.23|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||7.23|0.87|0.0125
73996634|NCT02187159|147540115|SUPERIORITY||Mean Difference (Final Values)|5.01|STANDARD_ERROR_OF_MEAN|1.647||0.0023|TWO_SIDED|95.0|1.78|8.24|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||8.24|1.78|0.0023
73996635|NCT02187159|147540117|SUPERIORITY||Difference in least squares means|-1.2|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-1.8|-0.7|||ANCOVA|||||-0.7|-1.8|<0.0001
73996636|NCT02187159|147540117|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0247|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||||-0.1|-1.2|0.0247
74036234|NCT01088438|147624844|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|1 degree of freedom||Null hypothesis: proportion of encounters with contextual red flag in which appropriate treatment is planned is the same in the two groups.||||<0.001
73996637|NCT02187159|147540117|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0411|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||||-0.0|-1.1|0.0411
73996638|NCT02187159|147540117|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0352|TWO_SIDED|95.0|0.0|1.2|||ANCOVA|||||1.2|0.0|0.0352
73996639|NCT02187159|147540117|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0214|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||||1.2|0.1|0.0214
73996640|NCT02187159|147540118|SUPERIORITY||Difference of least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.26||0.0003|TWO_SIDED|95.0|-1.5|-0.4|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||-0.4|-1.5|0.0003
73996641|NCT02187159|147540118|SUPERIORITY||Difference of least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5066|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.3|-0.7|0.5066
73996642|NCT02187159|147540118|SUPERIORITY||Difference of least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.26||0.1462|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.1|-0.9|0.1462
73996643|NCT02187159|147540118|SUPERIORITY||Difference of least squares means|0.8|STANDARD_ERROR_OF_MEAN|0.26||0.0035|TWO_SIDED|95.0|0.3|1.3|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.3|0.3|0.0035
73996644|NCT02187159|147540118|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.26||0.0338|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.1|0.0|0.0338
73996645|NCT02187159|147540118|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.28||0.0116|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||-0.2|-1.3|0.0116
73996646|NCT02187159|147540118|SUPERIORITY||Difference of least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7085|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0.4|-0.7|0.7085
73996647|NCT02187159|147540118|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.9392|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||0.6|-0.5|0.9392
73996648|NCT02187159|147540118|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0311|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.2|0.1|0.0311
74036235|NCT01088438|147624845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|1 degree of freedom||Null hypothesis is equal proportion of contextual red flags probed in control and intervention groups.||||<.001
73996649|NCT02187159|147540118|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|0.28||0.0094|TWO_SIDED|95.0|0.2|1.3|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.3|0.2|0.0094
73996650|NCT02187159|147540119|SUPERIORITY||Difference in least squares means|1.256|STANDARD_ERROR_OF_MEAN|0.6027||0.0373|TWO_SIDED|95.0|0.074|2.439|||ANCOVA|||Physical Component: Placebo vs Pregabalin||2.439|0.074|0.0373
74090387|NCT02696031|147734209|SUPERIORITY||LS Mean of Treatment Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.255||0.0002|TWO_SIDED|95.0|-1.47|-0.47||unadjusted p-value|mixed model repeated measures (MMRM)|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.47|-1.47|0.0002
73996651|NCT02187159|147540119|SUPERIORITY||Difference of least squares means|0.364|STANDARD_ERROR_OF_MEAN|0.602||0.5458|TWO_SIDED|95.0|-0.817|1.545|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||1.545|-0.817|0.5458
73996652|NCT02187159|147540119|SUPERIORITY||Difference in least squares means|0.235|STANDARD_ERROR_OF_MEAN|0.6038||0.6968|TWO_SIDED|95.0|-0.949|1.42|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||1.420|-0.949|0.6968
73996653|NCT02187159|147540119|SUPERIORITY||Difference in least squares means|-0.893|STANDARD_ERROR_OF_MEAN|0.6014||0.1379|TWO_SIDED|95.0|-2.073|0.287|||ANCOVA|||Physical Component: Pregabalin vs DS-5565 15 mg QD||0.287|-2.073|0.1379
73996654|NCT02187159|147540119|SUPERIORITY||Difference in least squares means|-1.021|STANDARD_ERROR_OF_MEAN|0.6033||0.0908|TWO_SIDED|95.0|-2.205|0.163|||ANCOVA|||Physical Component: Pregabalin vs DS-5565 15 mg BID||0.163|-2.205|0.0908
73996655|NCT02187159|147540119|SUPERIORITY||Difference in least squares means|1.89|STANDARD_ERROR_OF_MEAN|0.6965||0.0068|TWO_SIDED|95.0|0.523|3.256|||ANCOVA|||Mental Component: Placebo vs Pregabalin||3.256|0.523|0.0068
73996656|NCT02187159|147540119|SUPERIORITY||Difference in least squares means|0.406|STANDARD_ERROR_OF_MEAN|0.6956||0.5594|TWO_SIDED|95.0|-0.959|1.771|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.771|-0.959|0.5594
73996657|NCT02187159|147540119|SUPERIORITY||Difference in least squares means|0.023|STANDARD_ERROR_OF_MEAN|0.6979||0.9736|TWO_SIDED|95.0|-1.346|1.392|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||1.392|-1.346|0.9736
73996658|NCT02187159|147540119|SUPERIORITY||Difference in least squares means|-1.484|STANDARD_ERROR_OF_MEAN|0.6953||0.0331|TWO_SIDED|95.0|-2.848|-0.119|||ANCOVA|||Mental Component: Pregabalin vs DS-5565 15 mg QD||-0.119|-2.848|0.0331
73996659|NCT02187159|147540119|SUPERIORITY||Difference in least squares means|-1.867|STANDARD_ERROR_OF_MEAN|0.6976||0.0076|TWO_SIDED|95.0|-3.235|-0.498|||ANCOVA|||Mental Component: Pregabalin vs DS-5565 15 mg BID||-0.498|-3.235|0.0076
73996660|NCT02187159|147540120|SUPERIORITY||Difference in least squares means|0.0309|STANDARD_ERROR_OF_MEAN|0.01328||0.0201|TWO_SIDED|95.0|0.0048|0.057|||ANCOVA|||||0.0570|0.0048|0.0201
73996661|NCT02187159|147540120|SUPERIORITY||Difference of least squares means|0.0178|STANDARD_ERROR_OF_MEAN|0.01324||0.1798|TWO_SIDED|95.0|-0.0082|0.0438|||ANCOVA|||||0.0438|-0.0082|0.1798
73996662|NCT02187159|147540120|SUPERIORITY||Difference of least squares means|0.0071|STANDARD_ERROR_OF_MEAN|0.01329||0.5922|TWO_SIDED|95.0|-0.0189|0.0332|||ANCOVA|||||0.0332|-0.0189|0.5922
73996663|NCT02187159|147540120|SUPERIORITY||Difference in least squares means|-0.0131|STANDARD_ERROR_OF_MEAN|0.01326||0.3221|TWO_SIDED|95.0|-0.0392|0.0129|||ANCOVA|||||0.0129|-0.0392|0.3221
73996664|NCT02187159|147540120|SUPERIORITY||Difference in least squares means|-0.0238|STANDARD_ERROR_OF_MEAN|0.0133||0.0739|TWO_SIDED|95.0|-0.0499|0.0023|||ANCOVA|||||0.0023|-0.0499|0.0739
73996665|NCT02187159|147540121|SUPERIORITY||Difference in least squares means|-0.49|STANDARD_ERROR_OF_MEAN|0.153||0.0015|TWO_SIDED|95.0|-0.79|-0.19|||Mixed Models Analysis|||||-0.19|-0.79|0.0015
73996666|NCT02187159|147540121|SUPERIORITY||Difference in least squares means|-0.56|STANDARD_ERROR_OF_MEAN|0.153||0.0003|TWO_SIDED|95.0|-0.86|-0.26|||Mixed Models Analysis|||||-0.26|-0.86|0.0003
73996667|NCT02187159|147540121|SUPERIORITY||Difference in least squares means|-0.51|STANDARD_ERROR_OF_MEAN|0.153||0.0008|TWO_SIDED|95.0|-0.81|-0.21|||Mixed Models Analysis|||||-0.21|-0.81|0.0008
74090388|NCT02696031|147734210|SUPERIORITY||LS Mean|-1.61|STANDARD_ERROR_OF_MEAN|0.478||0.0008|TWO_SIDED|95.0|-2.54|-0.67||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.67|-2.54|0.0008
73996668|NCT02187159|147540121|SUPERIORITY||Difference in least squares means|-0.07|STANDARD_ERROR_OF_MEAN|0.154||0.6464|TWO_SIDED|95.0|-0.37|0.23|||Mixed Models Analysis|||||0.23|-0.37|0.6464
73996669|NCT02187159|147540121|SUPERIORITY||Difference in least squares means|-0.03|STANDARD_ERROR_OF_MEAN|0.154||0.8543|TWO_SIDED|95.0|-0.33|0.27|||Mixed Models Analysis|||||0.27|-0.33|0.8543
73996670|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0014|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||0.2|-1.0|0.0014
73996671|NCT02187159|147540123|SUPERIORITY||Difference of least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1285|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.1285
73996672|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.6595|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.6595
73996673|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0938|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0938
73996674|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0061|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0061
73996675|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0235|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||-0.1|-0.8|0.0235
73996676|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3652|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.2|-0.5|0.3652
74090389|NCT02696031|147734210|SUPERIORITY||LS Mean|-1.78|STANDARD_ERROR_OF_MEAN|0.479||0.0002|TWO_SIDED|95.0|-2.72|-0.84||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.84|-2.72|0.0002
73996677|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.6885|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||0.3|-0.4|0.6885
73996678|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1726|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.1|0.1726
73996679|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0627|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.0|0.0627
74090390|NCT02696031|147734211|SUPERIORITY|||||||0.0012||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||0.0012
73996680|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.0026|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||-0.2|-0.8|0.0026
74090391|NCT02696031|147734211|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
73996681|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1362|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||0.1|-0.6|0.1362
73996682|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.4344|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||0.2|-0.4|0.4344
73996683|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1264|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.1|0.1264
73996684|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.16||0.026|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|0.0|0.0260
73996685|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|0.0002
73996686|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0597|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0597
73996687|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1198|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||0.1|-0.7|0.1198
73996688|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.563|STANDARD_ERROR_OF_MEAN|0.1644||0.0006|TWO_SIDED|95.0|-0.885|-0.24|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||-0.240|-0.885|0.0006
73996689|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.261|STANDARD_ERROR_OF_MEAN|0.164||0.1118|TWO_SIDED|95.0|-0.583|0.061|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.061|-0.583|0.1118
74090392|NCT02696031|147734212|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0577|TWO_SIDED|95.0|0.98|3.45||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders. Patients were considered as non-responders after treatment switch decision."|3.45|0.98|0.0577
74090393|NCT02696031|147734212|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0003|TWO_SIDED|95.0|1.65|5.41||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders. Patients were considered as non-responders after treatment switch decision."|5.41|1.65|0.0003
73996690|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.142|STANDARD_ERROR_OF_MEAN|0.1646||0.387|TWO_SIDED|95.0|-0.465|0.18|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||0.180|-0.465|0.3870
73996691|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.302|STANDARD_ERROR_OF_MEAN|0.1642||0.0633|TWO_SIDED|95.0|-0.02|0.624|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.624|-0.020|0.0633
73996692|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.42|STANDARD_ERROR_OF_MEAN|0.1647||0.0108|TWO_SIDED|95.0|0.097|0.744|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.744|0.097|0.0108
73996693|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|7.5|STANDARD_ERROR_OF_MEAN|2.41||0.002|TWO_SIDED|95.0|2.7|12.2|||ANCOVA|||Relief by treatment of pain: Placebo vs Pregabalin 150 mg BID||12.2|2.7|0.0020
73996694|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|3.0|STANDARD_ERROR_OF_MEAN|2.41||0.2188|TWO_SIDED|95.0|-1.8|7.7|||ANCOVA|||Relief by treatment of pain: Placebo vs DS-5565 15 mg QD||7.7|-1.8|0.2188
73996695|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|4.0|STANDARD_ERROR_OF_MEAN|2.41||0.0991|TWO_SIDED|95.0|-0.8|8.7|||ANCOVA|||Relief by treatment of pain: Placebo vs DS-5565 15 mg BID||8.7|-0.8|0.0991
73996696|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-4.5|STANDARD_ERROR_OF_MEAN|2.41||0.0611|TWO_SIDED|95.0|-9.2|0.2|||ANCOVA|||Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.2|-9.2|0.0611
73996697|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-3.5|STANDARD_ERROR_OF_MEAN|2.41||0.1489|TWO_SIDED|95.0|-8.2|1.2|||ANCOVA|||Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.2|-8.2|0.1489
73996698|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-6.04|STANDARD_ERROR_OF_MEAN|1.751||0.0006|TWO_SIDED|95.0|-9.47|-2.6|||ANCOVA|||Interference: Placebo vs Pregabalin 150 mg BID||-2.60|-9.47|0.0006
73996699|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-4.09|STANDARD_ERROR_OF_MEAN|1.747||0.0193|TWO_SIDED|95.0|-7.52|-0.67|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg QD||-0.67|-7.52|0.0193
74090394|NCT02696031|147734213|SUPERIORITY||Relative Treatment Effect|0.7||||0.0002|TWO_SIDED|95.0|0.58|0.84||unadjusted p-value|MMRM|||week 16|Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value were from mixed-effect model repeated measures (MMRM) with treatment, visit, stratification factor and TNFi status as factors, log(e) baseline and weight as covariates, treatment by visit and log(e) baseline by visit as interaction terms and an unstructured covariance|0.84|0.58|0.0002
74090395|NCT02696031|147734213|SUPERIORITY||Relative Treatment Effect|0.7||||0.0002||95.0|0.58|0.84||unadjusted p-value|MMRM|||week 16|Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value were from mixed-effect model repeated measures (MMRM) with treatment, visit, stratification factor and TNFi status as factors, log(e) baseline and weight as covariates, treatment by visit and log(e) baseline by visit as interaction terms and an unstructured covariance structure.|0.84|0.58|0.0002
74090396|NCT02696031|147734214|SUPERIORITY||LS Mean of Treatment Difference|2.77|STANDARD_ERROR_OF_MEAN|0.799||0.0006|TWO_SIDED|95.0|1.2|4.34||unadjusted p-value|ANCOVA|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|4.34|1.20|0.0006
73876866|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|31.3||||0.052|TWO_SIDED|95.0|2.2|60.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.3|2.2|0.052
73876867|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||27.4|-47.4|0.709
73996700|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-1.64|STANDARD_ERROR_OF_MEAN|1.752||0.3506|TWO_SIDED|95.0|-5.07|1.8|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg BID||1.80|-5.07|0.3506
73996701|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|1.94|STANDARD_ERROR_OF_MEAN|1.748||0.266|TWO_SIDED|95.0|-1.48|5.37|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD||5.37|-1.48|0.2660
73996702|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|4.4|STANDARD_ERROR_OF_MEAN|1.754||0.0122|TWO_SIDED|95.0|0.96|7.84|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID||7.84|0.96|0.0122
73996703|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0119|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||General activity: Placebo vs Pregabalin 150 mg BID||-0.1|-0.9|0.0119
73996704|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0659|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0659
73996705|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5104|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.5104
73996706|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.4934|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.4934
73996707|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0634|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0634
73996708|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0007|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||Mood: Placebo vs Pregabalin 150 mg BID||-0.3|-1.1|0.0007
73996709|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0837|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0837
73996710|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2379|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg BID||0.2|-0.7|0.2379
73996711|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.098|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.0980
73996712|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0283|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.0|0.0283
73996713|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2179|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Walking ability: Placebo vs Pregabalin 150 mg BID||0.2|-0.7|0.2179
73996714|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6683|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.6683
73996715|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2247|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg BID||0.7|-0.2|0.2247
73996716|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4198|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.2|0.4198
73996717|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0146|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0146
73996718|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0662|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Normal work: Placebo vs Pregabalin 150 mg BID||0.0|-0.8|0.0662
73996719|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2282|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg QD||0.2|-0.7|0.2282
73996720|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7336|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.7336
73996721|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.524|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.5240
73996722|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1349|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1349
73996723|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0464|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs Pregabalin 150 mg BID||-0.0|-0.8|0.0464
73996724|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.0975|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.0975
73996725|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6088|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg BID||0.5|-0.3|0.6088
73996726|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7341|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.7341
73996727|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0125|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0125
73996728|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.4|-0.5|||ANCOVA|||Sleep: Placebo vs Pregabalin 150 mg BID||-0.5|-1.4|<0.0001
73996729|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg QD||-0.4|-1.3|0.0003
73996730|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.1|-0.2|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg BID||-0.2|-1.1|0.0040
73996731|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.5801|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.3|0.5801
73996732|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.1869|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1869
73996733|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0002|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|||Enjoyment of life: Placebo vs Pregabalin 150 mg BID||-0.4|-1.3|0.0002
73996734|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0271|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg QD||-0.1|-0.9|0.0271
73996735|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.1123|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg BID||0.1|-0.8|0.1123
73996736|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1183|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.1183
73996737|NCT02187159|147540123|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0299|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.0|0.0299
73996738|NCT02187159|147540124|SUPERIORITY||Difference in least squares means|-0.015|STANDARD_ERROR_OF_MEAN|0.0249||0.5578|TWO_SIDED|95.0|-0.063|0.034|||ANCOVA|||||0.034|-0.063|0.5578
73996739|NCT02187159|147540124|SUPERIORITY||Difference in least squares means|-0.009|STANDARD_ERROR_OF_MEAN|0.0248||0.7034|TWO_SIDED|95.0|-0.058|0.039|||ANCOVA|||||0.039|-0.058|0.7034
73996740|NCT02187159|147540124|SUPERIORITY||Difference in least squares means|-0.02|STANDARD_ERROR_OF_MEAN|0.0249||0.4143|TWO_SIDED|95.0|-0.069|0.028|||ANCOVA|||||0.028|-0.069|0.4143
73996741|NCT02187159|147540124|SUPERIORITY||Difference in least squares means|0.005|STANDARD_ERROR_OF_MEAN|0.0249||0.8365|TWO_SIDED|95.0|-0.044|0.054|||ANCOVA|||||0.054|-0.044|0.8365
73996742|NCT02187159|147540124|SUPERIORITY||Difference in least squares means|-0.006|STANDARD_ERROR_OF_MEAN|0.0249||0.8189|TWO_SIDED|95.0|-0.055|0.043|||ANCOVA|||||0.043|-0.055|0.8189
73996743|NCT04020185|147540125|OTHER||maximum tolerated dose (monotherapy)|1200.0|||||TWO_SIDED|||||||||||||
73996744|NCT00567567|147540127|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|6.9883||||0.0082|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - Single HST (CEM) and randomized to Regimen B - Tandem HST (CEM) were compared using the log-rank test.||||0.0082
73996745|NCT00567567|147540128|SUPERIORITY_OR_OTHER_LEGACY||Chi-squared test statistic|8.5751||||0.0034|TWO_SIDED|95.0|||||Chi-squared|||Chi-square test of proportions in all patients to compare the proportion of responders (complete response \[CR\]+ very good partial response \[VGPR\]) at the end of induction therapy in this study to an analogous cohort of responders in A3973.||||0.0034
73996746|NCT00567567|147540129|SUPERIORITY_OR_OTHER_LEGACY||Gray's test statistic|0.33709||||0.5615|TWO_SIDED|95.0|||||Gray's test for competing risks|||The cumulative incidence rates of local recurrence between patients from ANBL0532 randomized or assigned to receive single CEM transplant and boost radiation and A3973 patients who were transplanted and received boost radiation were compared using Gray's test.||||0.5615
73996747|NCT00567567|147540130|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.0557||||0.0939|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.0939
73996748|NCT00567567|147540131|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.0543||||0.3277|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.3277
73996749|NCT00567567|147540132|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4328||||0.7598|TWO_SIDED|95.0|0.4105|5.001|||Fisher Exact|Fisher's exact test was used instead of chi-square test due to small expected cell counts.||Null Hypothesis: The response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population||5.001|0.4105|0.7598
73996750|NCT00567567|147540136|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.015||||0.6853|TWO_SIDED|95.0|||||Regression, Cox|||The relationship between the peak serum isotretinoin concentration level with event-free survival was explored with a Cox proportional hazards model. Eligible patients treated with isotretinoin on A3973, ANBL0032, ANBL0532, or ANBL0931 with peak serum concentration level data were included in the analysis.||||0.6853
73996751|NCT03433677|147540144|SUPERIORITY||Median Difference (Final Values)|0.0||||0.375|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon signed-rank test|||||0.00|0.00|0.375
73996752|NCT03433677|147540145|SUPERIORITY|||||||0.468|||||||Prescott's Exact test|||||||0.468
73996753|NCT03433677|147540146|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
73996754|NCT03433677|147540147|SUPERIORITY||LSMean Difference|-1.8||||0.304|TWO_SIDED|95.0|-5.3|1.7|||Mixed Models Analysis|||||1.7|-5.3|0.304
73996755|NCT03433677|147540148|SUPERIORITY||LSMean Difference|-2.4||||0.057|TWO_SIDED|95.0|-4.8|0.1|||Mixed Models Analysis|||||0.1|-4.8|0.057
73996756|NCT03433677|147540149|SUPERIORITY||LSMeans|0.11||||0.177|TWO_SIDED|95.0|-0.05|0.27|||Mixed Models Analysis||LSMean Difference|||0.27|-0.05|0.177
73996757|NCT03268603|147540195|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
73996758|NCT03921723|147540287|EQUIVALENCE|Bioequivalence is established when the 90 percent (%) confidence interval of the ratio for AUC (0 to t) between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
73996759|NCT03921723|147540287|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to t) between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.12|||||TWO_SIDED|90.0|1.05|1.2||||||||1.20|1.05|
73996760|NCT03921723|147540306|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to inf) between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|0.96|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
73996761|NCT03921723|147540306|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to inf) between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.13||||||90.0|1.06|1.2||||||||1.20|1.06|
73996762|NCT03921723|147540307|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for Cmax between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.09|||||TWO_SIDED|90.0|1.01|1.19||||||||1.19|1.01|
73996763|NCT03921723|147540307|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for Cmax between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.22|||||TWO_SIDED|90.0|1.13|1.33||||||||1.33|1.13|
73996764|NCT00406692|147540321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.5|<|0.0003|TWO_SIDED|95.0||||Null Hypothesis: No difference in the mean daily standard drinks consumed for the baseline period and the zonisamide treatment weeks|Mixed Models Analysis|||Null Hypothesis: No difference in the mean daily standard drinks consumed between the baseline period and the zonisamide treatment weeks.||||<0.0003
73996765|NCT00406692|147540322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7|STANDARD_ERROR_OF_MEAN|3.9|<|0.22|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant change in the mean number of words produced during phonetic portion of the Controlled Word Association Test between the baseline period and the treatment weeks.||||<0.22
73996766|NCT00406692|147540323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|4.0|<|0.55|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant difference for mean scores obtained for baseline, week 4 and week 12.||||< 0.55
73996767|NCT02193490|147540340|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
73996768|NCT02193490|147540341|OTHER|||||||0.078|||||||Kruskal-Wallis|||||||0.078
73996769|NCT02193490|147540342|OTHER||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
73996770|NCT02299414|147540343|SUPERIORITY||Risk Ratio (RR)|0.82|||<|0.001|TWO_SIDED|95.0|0.73|0.92|||Chi-squared|||||.92|.73|<0.001
73996771|NCT02299414|147540343|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.7|0.9||||||||.90|.70|
73996772|NCT02299414|147540343|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.6|0.89||||||||.89|.60|
73996773|NCT02299414|147540343|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.49|1.64||||||||1.64|.49|
73996774|NCT02299414|147540343|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.54|1.21||||||||1.21|.54|
73996775|NCT02299414|147540344|SUPERIORITY||Risk Ratio (RR)|1.07||||0.56|TWO_SIDED|95.0|0.85|1.36|||Chi-squared|||||1.36|0.85|0.56
73996776|NCT02299414|147540345|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.45|1.26||||||||1.26|.45|
73996777|NCT02299414|147540346|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.77|0.91||||||||0.91|0.77|
73996778|NCT02299414|147540347|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.77|0.99||||||||.99|.77|
73996779|NCT02299414|147540348|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.45|1.3||||||||1.3|.45|
73996780|NCT02299414|147540349|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.98|1.18||||||||1.18|.98|
73996781|NCT02299414|147540350|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.69|0.89||||||||.89|.69|
73996782|NCT02299414|147540351|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.68|1.04||||||||1.04|0.68|
73996783|NCT02299414|147540352|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.74|0.9||||||||.90|.74|
73996784|NCT02299414|147540353|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.93|1.1||||||||1.10|.93|
73996785|NCT02299414|147540354|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.59|1.27||||||||1.27|.59|
73996786|NCT02299414|147540355|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.81|1.02||||||||1.02|.81|
73996787|NCT02299414|147540356|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.71|0.97||||||||.97|.71|
73996788|NCT02299414|147540357|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.11|0.43||||||||0.43|-0.11|
73996789|NCT02299414|147540358|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|0.05|0.56||||||||0.56|0.05|
73996790|NCT02299414|147540359|SUPERIORITY||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-17.6|20.9||||||||20.9|-17.6|
73996791|NCT02299414|147540360|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|.81|
73996792|NCT02299414|147540361|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.55|1.42||||||||1.42|.55|
73996793|NCT02299414|147540362|SUPERIORITY||Risk Ratio (RR)|0.43|||||TWO_SIDED|95.0|0.18|1.05||||||||1.05|.18|
73996794|NCT02299414|147540363|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.71|1.06||||||||1.06|.71|
73996795|NCT02299414|147540364|SUPERIORITY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.24|1.35||||||||1.35|.24|
73996796|NCT02299414|147540365|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.85|1.12||||||||1.12|.85|
73996797|NCT02299414|147540366|SUPERIORITY||Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.3|1.37||||||||1.37|0.30|
73996798|NCT02299414|147540367|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.14|7.06||||||||7.06|.14|
73996799|NCT02299414|147540368|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.81|1.08||||||||1.08|.81|
73996800|NCT02299414|147540369|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.62|1.16||||||||1.16|0.62|
73996801|NCT02299414|147540370|SUPERIORITY||Risk Ratio (RR)|0.61|||||TWO_SIDED|95.0|0.36|1.05||||||||1.05|.36|
73996802|NCT02299414|147540371|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.2|0.03||||||||0.03|-0.2|
73996803|NCT02299414|147540372|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
73996804|NCT02299414|147540373|SUPERIORITY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.12|0.002||||||||0.002|-0.12|
73996805|NCT02299414|147540374|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||||0.04|-0.02|
73996806|NCT02299414|147540375|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.9|1.06||||||||1.06|0.90|
73996807|NCT02628028|147540386|SUPERIORITY|||||||0.473|||||||Regression, Logistic|||||||0.473
73996808|NCT02628028|147540386|SUPERIORITY|||||||0.67|||||||Regression, Logistic|||||||0.670
73996809|NCT02628028|147540386|SUPERIORITY|||||||0.823|||||||Regression, Logistic|||||||0.823
73996810|NCT02628028|147540387|SUPERIORITY|||||||0.743|||||||Regression, Logistic|||||||0.743
73996811|NCT02628028|147540387|SUPERIORITY|||||||0.124|||||||Regression, Logistic|||||||0.124
73996812|NCT02628028|147540387|SUPERIORITY|||||||0.858|||||||Regression, Logistic|||||||0.858
73996813|NCT02628028|147540388|SUPERIORITY|||||||0.199|||||||Regression, Logistic|||||||0.199
73996814|NCT02628028|147540388|SUPERIORITY|||||||0.028|||||||Regression, Logistic|||||||0.028
73996815|NCT02628028|147540388|SUPERIORITY|||||||0.863|||||||Regression, Logistic|||||||0.863
73996816|NCT02628028|147540389|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.25||0.863|TWO_SIDED|95.0|-0.53|0.44|||Mixed-effects Model for Repeated Measure|||||0.44|-0.53|0.863
73996817|NCT02628028|147540389|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.25||0.503|TWO_SIDED|95.0|-0.32|0.65|||Mixed-effects Model for Repeated Measure|||||0.65|-0.32|0.503
73996818|NCT02628028|147540389|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.25||0.289|TWO_SIDED|95.0|-0.77|0.23|||Mixed-effects Model for Repeated Measure|||||0.23|-0.77|0.289
73996819|NCT02628028|147540390|SUPERIORITY|||||||0.626|||||||Regression, Logistic|||||||0.626
73996820|NCT02628028|147540390|SUPERIORITY|||||||0.418|||||||Regression, Logistic|||||||0.418
73996821|NCT02628028|147540390|SUPERIORITY|||||||0.951|||||||Regression, Logistic|||||||0.951
73996822|NCT02628028|147540391|SUPERIORITY|||||||0.905|||||||Regression, Logistic|||||||0.905
73996823|NCT02628028|147540391|SUPERIORITY|||||||0.069|||||||Regression, Logistic|||||||0.069
73996824|NCT02628028|147540391|SUPERIORITY|||||||0.547|||||||Regression, Logistic|||||||0.547
73996825|NCT02145468|147540393|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.238|TWO_SIDED|95.0|0.91|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|||1.47|0.91|0.238
73996826|NCT02145468|147540394|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.329|TWO_SIDED|95.0|0.9|1.38|||Log Rank||"Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk.~with the treatment compared with placebo."|||1.38|0.90|0.329
73996827|NCT02145468|147540395|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.338|TWO_SIDED|95.0|0.88|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.47|0.88|0.338
73996828|NCT02145468|147540395|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.41|TWO_SIDED|95.0|0.88|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.38|0.88|0.410
73996829|NCT02145468|147540396|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.472|TWO_SIDED|95.0|0.86|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death, MI or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.38|0.86|0.472
73996830|NCT02145468|147540397|SUPERIORITY||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.91|1.44|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of arterial CV events (CV death, MI, SRI-UR or stroke), Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.44|0.91|
73996831|NCT02145468|147540398|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.505|TWO_SIDED|95.0|0.86|1.36|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of coronary events (CHD death, MI, SRI-UR or any unplanned coronary artery revascularization), Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.36|0.86|0.505
73996832|NCT02145468|147540399|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.536|TWO_SIDED|95.0|0.64|1.26|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.26|0.64|0.536
73996833|NCT02145468|147540399|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6|TWO_SIDED|95.0|0.69|1.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.24|0.69|0.6
74036236|NCT01088438|147624846|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Chi-squared|1 df||Null hypothesis is equal proportion of encounters probed in control and intervention groups.||||0.85
73996834|NCT02145468|147540400|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.356|TWO_SIDED|95.0|0.88|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI or stroke, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.43|0.88|0.356
73876868|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|32.5||||0.194|TWO_SIDED|95.0|0.9|64.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||64.1|0.9|0.194
73996835|NCT02145468|147540401|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.329|TWO_SIDED|95.0|0.9|1.39|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI, SRI-UR, stroke or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.39|0.9|0.329
73996836|NCT02145468|147540402|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.285|TWO_SIDED|95.0|0.89|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death, MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.47|0.89|0.285
73996837|NCT02145468|147540403|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.401|TWO_SIDED|95.0|0.86|1.46|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.46|0.86|0.401
73996838|NCT02145468|147540404|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.295|TWO_SIDED|95.0|0.89|1.44|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death, MI or SRI-UR,Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.44|0.89|0.295
73996839|NCT02145468|147540405|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.412|TWO_SIDED|95.0|0.86|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.43|0.86|0.412
73996840|NCT02145468|147540406|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.469|TWO_SIDED|95.0|0.83|1.49|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, type I (spontaneous) MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.49|0.83|0.469
73996841|NCT02145468|147540407|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.664|TWO_SIDED|95.0|0.78|1.48|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or type I (spontaneous) MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.48|0.78|0.664
73996842|NCT02145468|147540408|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.13|TWO_SIDED|95.0|0.27|1.19|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Participants with first occurrence of definite or probable stent thrombosis, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.19|0.27|0.130
73996843|NCT02145468|147540409|SUPERIORITY||Odds Ratio (OR)|1.03||||0.744|TWO_SIDED|95.0|0.84|1.27|||Wald chi-squared||Odds ratio is estimated using a logistic regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. An odds ratio \<1 indicates a lower risk with the treatment compared with placebo.|||1.27|0.84|0.744
73996844|NCT02145468|147540410|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.309|TWO_SIDED|95.0|0.53|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Participants with all-cause mortality, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.22|0.53|0.309
73996845|NCT02145468|147540411|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.398|TWO_SIDED|95.0|0.53|1.28|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.28|0.53|0.398
73996846|NCT02145468|147540411|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.264|TWO_SIDED|95.0|0.55|1.18|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.18|0.55|0.264
73996847|NCT02145468|147540412|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.251|TWO_SIDED|95.0|0.47|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CHD death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.22|0.47|0.251
73876869|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|13.8||||0.4|TWO_SIDED|95.0|-17.7|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||45.2|-17.7|0.400
73996848|NCT02145468|147540413|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.182|TWO_SIDED|95.0|0.91|1.67|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.67|0.91|0.182
73996849|NCT02145468|147540413|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.158|TWO_SIDED|95.0|0.93|1.58|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.58|0.93|0.158
73996850|NCT02145468|147540414|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.21|TWO_SIDED|95.0|0.85|2.12|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Type I (spontaneous) MI events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||2.12|0.85|0.21
73996851|NCT02145468|147540415|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.697|TWO_SIDED|95.0|0.58|2.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|SRI-UR events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||2.24|0.58|0.697
73996852|NCT02145468|147540416|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.883|TWO_SIDED|95.0|0.46|1.96|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Stroke (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.96|0.46|0.883
73996853|NCT02145468|147540417|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.457|TWO_SIDED|95.0|0.54|1.32|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.32|0.54|0.457
73996854|NCT02145468|147540417|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.736|TWO_SIDED|95.0|0.63|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.38|0.63|0.736
73996855|NCT02145468|147540418|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.581|TWO_SIDED|95.0|0.77|1.59|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Any unplanned coronary revascularization, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.59|0.77|0.581
73996856|NCT04157400|147540419|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
73996857|NCT04157400|147540420|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73996858|NCT04157400|147540421|OTHER||||||||||||||||||Segments of EMG recorded during walking at self-selected walking speed were used to investigate complexity of muscle synergies using a nonnegative matrix factorization (NNMF) algorithm (MATLAB®, Mathworks, Natick, MA). The approach involves calculation of an mxt matrix of the original EMG data (EMG0), where m represents the number of muscles being measured and t represents a time base normalized to percentage of gait cycle. The algorithm also calculates two surrogate matrices, mxn and nxt, where n is the amplitude of muscle activation. The product of the surrogate matrices are considered a reconstruction of EMG (EMGr). EMGr for each module is then compared to EMG0 by finding the variability accounted for (VAF). A threshold necessary for module classification was chosen to be 90% for all conditions (8 muscles + 6 phases of gait) based on similar studies in the literature. Classifications were not increased unless the higher module VAF was at least 5% higher than the preceding module.|||
73996859|NCT05014568|147540545|SUPERIORITY||Risk Ratio, log|2.6|||<|0.0001|TWO_SIDED|95.0|1.66|4.09|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|H0: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is equal between tapinarof cream, 1% and vehicle cream; H1: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is different between the tapinarof cream, 1% and vehicle cream.||4.09|1.66|<0.0001
73996860|NCT05014568|147540546|SUPERIORITY||Risk Ratio, log|2.17|||<|0.0001|TWO_SIDED|95.0|1.57|3.0|||Cochran-Mantel-Haenszel|Stratified by vIGA-AD score at Baseline (vIGA-AD scores of 3 or 4) and age group (2-6 yrs, 7-11 yrs, 12-17 yrs, 18+ yrs)|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.00|1.57|<0.0001
73996861|NCT05014568|147540547|SUPERIORITY||Least squares mean difference|-6.17|STANDARD_ERROR_OF_MEAN|0.657|<|0.0001|TWO_SIDED|95.0|-7.69|-4.66|||ANCOVA|age\*vIGA cohort and treatment as categorical covariates, and baseline %BSA as a continuous covariate||||-4.66|-7.69|<0.0001
73996862|NCT05014568|147540548|SUPERIORITY||Risk Ratio, log|3.74|||<|0.0001|TWO_SIDED|95.0|1.98|7.09|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||7.09|1.98|<0.0001
73996863|NCT05014568|147540549|SUPERIORITY||Risk Ratio, log|1.54||||0.0366|TWO_SIDED|95.0|1.03|2.31|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||2.31|1.03|0.0366
73996864|NCT04893460|147540550|SUPERIORITY|This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Cost activity|Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.33||0.003|TWO_SIDED||||||t-test, 2 sided|||||||.003
73996865|NCT04893460|147540550|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Quit Letter activity||||<.001
73996866|NCT04893460|147540550|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.41||0.004|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Pitfalls activity||||.004
73996867|NCT04893460|147540550|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.48||0.098|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Smoke Free activity||||.098
73996868|NCT04893460|147540550|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|0.68||0.042|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Letter to Youth activity||||.042
73996869|NCT04893460|147540550|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.22||0.364|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to 6 weeks post baseline.||||.364
73996870|NCT04893460|147540551|SUPERIORITY||median pairwise average|17.67|||<|0.001|TWO_SIDED||||||Wilcoxson Signed Rank Test|||The non-parametric Wilcoxon signed-rank test was used to evaluate whether participants were smoking fewer cigarettes per day.||||<.001
73996871|NCT04893460|147540552|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Cost activity|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.42||0.776|TWO_SIDED||||||t-test, 2 sided|||||||.776
73996872|NCT04893460|147540552|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Quit Latter activity|Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.45||0.219|TWO_SIDED||||||t-test, 2 sided|||||||.219
73996873|NCT04893460|147540552|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Pitfalls activity|Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.55||0.043|TWO_SIDED||||||t-test, 2 sided|||||||.043
73996874|NCT04893460|147540552|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Smoke Free activity|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.67||0.219|TWO_SIDED||||||t-test, 2 sided|||||||.219
73996875|NCT04893460|147540552|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Letter to Youth activity|Mean Difference (Final Values)|-1.41|STANDARD_ERROR_OF_MEAN|0.54||0.11|TWO_SIDED||||||t-test, 2 sided|||||||.110
73996876|NCT04893460|147540552|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to 6 week post baseline assessment|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.26||0.868|TWO_SIDED||||||t-test, 2 sided|||||||.868
74008548|NCT05314712|147566900|OTHER|Linear Mixed Model (repeated measures model) of sleep trouble||||||||||||There was no hypothesis test. All participants received the 7-week intervention - there was no comparison group. A variable selection approach (AIC) was used for including the final variables in the model.||||Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. Under the assumption that the likert scale data was treated as continuous, the data was analyzed using a linear mixed model. Variables in final model were included after variable selection (details below).|Using an exhaustive search of all models (dredge) that could be formed from predictor variables partner sleep rating, perceived stress, DASS scale, 8-item diet scale, amount of screen time, amount of time between bed time and wake time, amount of time to fall asleep, hours of sleep, sleep rating score, indicator variable if the child played outside, bed time, and wake time, adult height in inches, adult BMI, adult's highest education attained, the number of children in the household, grade of the child, child height in inches, child BMI, age of the child, and gender of the child, requiring the the timing of the survey be in the model, and accounting for repeated measurements over time, using AIC as the selection criterion we looked for the model with the smallest AIC value. The final sleep trouble model included the covariates timing of survey, DASS scale, and indicator variable if child played outside.|||
74008549|NCT05314712|147566900|OTHER|Mixed effects linear regression model of hours slept||||||||||||There was no hypothesis test. All participants received the 7-week intervention - there was no comparison group. A variable selection approach (AIC) was used for including the final variables in the model.||||Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. The data was analyzed using a mixed effects linear regression model. Variables in final model were included after variable selection (details below).|Using an exhaustive search of all models (dredge) that could be formed from predictor variables partner sleep rating, perceived stress, DASS scale, 8-item diet scale, amount of screen time, amount of time between bed time and wake time, amount of time to fall asleep, hours of sleep, sleep rating score, indicator variable if the child played outside, bed time, and wake time, adult height in inches, adult BMI, adult's highest education attained, the number of children in the household, grade of the child, child height in inches, child BMI, age of the child, and gender of the child, requiring the the timing of the survey be in the model, and accounting for repeated measurements over time, using AIC as the selection criterion we looked for the model with the smallest AIC value. The final model for hours slept included the covariates number of children in the household, indicator variable if child played outside, and baseline hours slept.|||
74008550|NCT00782288|147566901|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Measures were compared between Baseline, Treatment \& Recovery periods to determine if changes from baseline differed between placebo and the two digitoxin dose levels. Kruskal-Wallis equity of population rank test was performed on the changes Day 28 minus Day 1. To compare the change from baseline to treatment period between the two arms, a Wilcoxon rank sum test was performed. To determine whether induced sputum Il-8 returned to baseline at the final visit, a one sample sign test was performed.||||>0.05
74008551|NCT00782288|147566907|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline,Treatment and Recovery periods were compared to determine if changes from baseline differed between placebo and the two digitoxin doses.||||>0.05
74008552|NCT00088907|147566956|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Log Rank|||||||0.60
74008553|NCT00088907|147566957|SUPERIORITY_OR_OTHER|||||||0.19|||||||Log Rank|||||||0.19
73996877|NCT01253135|147540553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|4.7||0.3393|TWO_SIDED|95.0|-3.08|0.84|||Prentice-Wilcoxon test||The Confidence Interval was based on a t-distribution|||0.84|-3.08|.3393
73996878|NCT01253135|147540554|SUPERIORITY_OR_OTHER|||||||0.4771|TWO_SIDED||||||Log Rank|Testing was by a Log Rank test with significance being at P \< 0.05||||||.4771
73996879|NCT03248882|147540576|SUPERIORITY||Mean Difference (Net)|-10.7|||||TWO_SIDED|80.0|-19.4|-1.1||||||||-1.1|-19.4|
73996880|NCT03248882|147540576|SUPERIORITY||Mean Difference (Net)|-46.0|||||TWO_SIDED|80.0|-51.3|-40.1||||||||-40.1|-51.3|
73996881|NCT03248882|147540576|SUPERIORITY||Mean Difference (Net)|-52.4|||||TWO_SIDED|80.0|-57.2|-47.1||||||||-47.1|-57.2|
73996882|NCT03248882|147540576|SUPERIORITY||Mean Difference (Net)|-62.1|||||TWO_SIDED|80.0|-66.0|-57.8||||||||-57.8|-66.0|
73996883|NCT03248882|147540577|SUPERIORITY||Mean Difference (Net)|-4.4|||||TWO_SIDED|80.0|-14.0|6.3||||||||6.3|-14.0|
73996884|NCT03248882|147540577|SUPERIORITY||Mean Difference (Net)|-21.0|||||TWO_SIDED|80.0|-29.0|-12.2||||||||-12.2|-29.0|
73996885|NCT03248882|147540577|SUPERIORITY||Mean Difference (Net)|-25.0|||||TWO_SIDED|80.0|-32.8|-16.1||||||||-16.1|-32.8|
73996886|NCT03248882|147540577|SUPERIORITY||Mean Difference (Net)|-41.8|||||TWO_SIDED|80.0|-47.9|-35.0||||||||-35.0|-47.9|
73996887|NCT03733314|147540668|SUPERIORITY||Difference|10.3|||||TWO_SIDED|95.0|-24.9|45.4|||||The difference of percentage was calculated as E6011 minus placebo.|||45.4|-24.9|
73996888|NCT03733314|147540673|SUPERIORITY||Difference|-7.1|||||TWO_SIDED|95.0|-32.1|18.0|||||The difference of percentage was calculated as E6011 minus placebo.|||18.0|-32.1|
73996889|NCT03733314|147540674|SUPERIORITY||Difference|8.3|||||TWO_SIDED|95.0|-7.3|24.0|||||The difference of percentage was calculated as E6011 minus placebo.|||24.0|-7.3|
73996890|NCT01240915|147540685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.223||0.96|TWO_SIDED|80.0|0.12|0.69||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||0.69|0.12|0.96
73996891|NCT01240915|147540686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.161||0.54|TWO_SIDED|80.0|-0.19|0.22||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 4)||0.22|-0.19|0.54
73996892|NCT01240915|147540687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.174||0.67|TWO_SIDED|80.0|-0.15|0.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 8)||0.30|-0.15|0.67
73996893|NCT01240915|147540694|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.02||||0.53|TWO_SIDED|80.0|0.73|1.42||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||1.42|0.73|0.53
73996894|NCT01240915|147540694|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.48||||0.91|TWO_SIDED|80.0|1.02|2.14||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||2.14|1.02|0.91
73996895|NCT01240915|147540694|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.38||||0.81|TWO_SIDED|80.0|0.86|2.23||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||2.23|0.86|0.81
73996896|NCT01240915|147540694|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94||||0.44|TWO_SIDED|80.0|0.59|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.51|0.59|0.44
73996897|NCT01240915|147540694|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.18||||0.67|TWO_SIDED|80.0|0.72|1.94||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.94|0.72|0.67
73996898|NCT01240915|147540694|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12||||0.62|TWO_SIDED|80.0|0.68|1.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||1.84|0.68|0.62
73996899|NCT01240915|147540694|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95||||0.95|TWO_SIDED|80.0|0.58|1.57||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.57|0.58|0.95
73996900|NCT01240915|147540694|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.81||||0.3|TWO_SIDED|80.0|0.49|1.36||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.36|0.49|0.30
73996901|NCT01240915|147540695|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.17||||0.79|TWO_SIDED|80.0|0.91|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||1.51|0.91|0.79
73996902|NCT01240915|147540695|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.21||||0.8|TWO_SIDED|80.0|0.9|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||1.63|0.90|0.80
73996903|NCT01240915|147540695|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.75||||0.99|TWO_SIDED|80.0|1.63|4.64||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||4.64|1.63|0.99
73996904|NCT01240915|147540695|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.96||||0.96|TWO_SIDED|80.0|1.19|3.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||3.25|1.19|0.96
73996905|NCT01240915|147540695|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.98||||0.95|TWO_SIDED|80.0|1.15|3.41||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||3.41|1.15|0.95
73996906|NCT01240915|147540695|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.3||||0.99|TWO_SIDED|80.0|1.52|3.48||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||3.48|1.52|0.99
73996907|NCT01240915|147540695|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1||||0.62|TWO_SIDED|80.0|0.74|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.63|0.74|0.62
73996908|NCT01240915|147540695|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.51||||0.89|TWO_SIDED|80.0|0.98|2.32||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||2.32|0.98|0.89
73996909|NCT01240915|147540696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.34|TWO_SIDED|80.0|0.66|2.19||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)||2.19|0.66|0.34
73996910|NCT01240915|147540696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.33|TWO_SIDED|80.0|0.68|2.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)||2.23|0.68|0.33
73996911|NCT01240915|147540696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.1|TWO_SIDED|80.0|0.99|5.67||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)||5.67|0.99|0.10
73996912|NCT01240915|147540696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.74|TWO_SIDED|80.0|0.28|1.55||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.55|0.28|0.74
73996913|NCT01240915|147540696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.48|TWO_SIDED|80.0|0.41|2.64||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)||2.64|0.41|0.48
73996914|NCT01240915|147540696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.58|TWO_SIDED|80.0|0.38|2.03||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.03|0.38|0.58
73996915|NCT01240915|147540696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.68|TWO_SIDED|80.0|0.33|1.66||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.66|0.33|0.68
73996916|NCT01240915|147540696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.84|TWO_SIDED|80.0|0.21|1.23||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.23|0.21|0.84
73996917|NCT01240915|147540697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.57|TWO_SIDED|80.0|0.22|3.07||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||3.07|0.22|0.57
73996918|NCT01240915|147540698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.85|TWO_SIDED|80.0|0.12|1.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||1.23|0.12|0.85
73996919|NCT01240915|147540699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27||||0.05|TWO_SIDED|80.0|1.21|4.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)||4.24|1.21|0.05
73996920|NCT01240915|147540699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.43|TWO_SIDED|80.0|0.61|1.95||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)||1.95|0.61|0.43
73996921|NCT01240915|147540699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.44|TWO_SIDED|80.0|0.45|2.76||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)||2.76|0.45|0.44
73996922|NCT01240915|147540699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.38|TWO_SIDED|80.0|0.5|3.04||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)||3.04|0.50|0.38
73996923|NCT01240915|147540699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.89|TWO_SIDED|80.0|0.14|1.04||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.04|0.14|0.89
73996924|NCT01240915|147540699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.47|TWO_SIDED|80.0|0.45|2.42||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.42|0.45|0.47
73996925|NCT01240915|147540699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.24|TWO_SIDED|80.0|0.7|3.57||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)||3.57|0.70|0.24
73996926|NCT01240915|147540699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.81|TWO_SIDED|80.0|0.22|1.32||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.32|0.22|0.81
73996927|NCT01240915|147540700|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.84|TWO_SIDED|80.0|0.2|1.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||1.24|0.20|0.84
73996928|NCT01240915|147540701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.96|TWO_SIDED|80.0|0.12|0.73||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||0.73|0.12|0.96
73996929|NCT01240915|147540702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.513||0.87|TWO_SIDED|80.0|-0.08|1.24||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||1.24|-0.08|0.87
73876870|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.9|32.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||32.9|-42.9|1.000
73996930|NCT01240915|147540703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.345||0.8|TWO_SIDED|80.0|-0.15|0.74||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||0.74|-0.15|0.80
73996931|NCT01240915|147540703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.418||0.77|TWO_SIDED|80.0|-0.23|0.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||0.84|-0.23|0.77
73996932|NCT01240915|147540703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.666||0.74|TWO_SIDED|80.0|-0.42|1.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||1.30|-0.42|0.74
73996933|NCT01240915|147540703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.645||0.88|TWO_SIDED|80.0|-0.08|1.59||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.59|-0.08|0.88
73996934|NCT01240915|147540703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.705||0.72|TWO_SIDED|80.0|-0.5|1.33||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.33|-0.50|0.72
73996935|NCT01240915|147540703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|0.656||0.97|TWO_SIDED|80.0|0.37|2.06||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.06|0.37|0.97
73996936|NCT01240915|147540703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.635||0.75|TWO_SIDED|80.0|-0.39|1.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.25|-0.39|0.75
73996937|NCT01240915|147540703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.692||0.85|TWO_SIDED|80.0|-0.16|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.63|-0.16|0.85
73996938|NCT01240915|147540704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.753||0.75|TWO_SIDED|80.0|-0.46|1.49||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||1.49|-0.46|0.75
73996939|NCT01240915|147540705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.144||0.51|TWO_SIDED|80.0|-0.18|0.19||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||0.19|-0.18|0.51
73996940|NCT01240915|147540705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.158||0.62|TWO_SIDED|80.0|-0.16|0.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||0.25|-0.16|0.62
73996941|NCT01240915|147540705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.213||0.29|TWO_SIDED|80.0|-0.39|0.16||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||0.16|-0.39|0.29
73996942|NCT01240915|147540705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.209||0.74|TWO_SIDED|80.0|-0.14|0.4||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||0.40|-0.14|0.74
73996943|NCT01240915|147540705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.226||0.36|TWO_SIDED|80.0|-0.37|0.21||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||0.21|-0.37|0.36
73996944|NCT01240915|147540705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.234||0.56|TWO_SIDED|80.0|-0.26|0.34||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||0.34|-0.26|0.56
73996945|NCT01240915|147540705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.231||0.18|TWO_SIDED|80.0|-0.51|0.09||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||0.09|-0.51|0.18
73996946|NCT01240915|147540705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.31|TWO_SIDED|80.0|-0.45|0.2||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||0.20|-0.45|0.31
73996947|NCT04514510|147540706|SUPERIORITY|||||||0.64|||||||ANCOVA with Multiple Imputation|||||||0.64
73996948|NCT04514510|147540712|SUPERIORITY|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
73996949|NCT04488770|147540764|OTHER||Ratio of Geometric Mean|0.75|||||TWO_SIDED|90.0|0.61|0.93|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-24). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Unstructured covariance structure is used.|||0.93|0.61|
73996950|NCT04488770|147540765|OTHER||Ratio of Geometric Mean|0.8|||||TWO_SIDED|90.0|0.65|0.98|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.98|0.65|
73996951|NCT04488770|147540766|OTHER||Ratio of Geometric Mean|0.8|||||TWO_SIDED|90.0|0.65|0.98|||||Mixed Effect Model was used to assess Food Effect for log transformed parameter AUC(0-infinity). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.98|0.65|
73996952|NCT04488770|147540767|OTHER||Ratio of Geometric Mean|0.59|||||TWO_SIDED|90.0|0.46|0.75|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.75|0.46|
73996953|NCT04488770|147540768|OTHER||Ratio of Geometric Mean|0.91|||||TWO_SIDED|90.0|0.74|1.11|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter C24h. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||1.11|0.74|
73996954|NCT04488770|147540769|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|90.0|0.0|2.0|||||Wilcoxon matched pair test was used to assess Food Effect for the parameter Tmax.|||2.000|0.000|
73996955|NCT04488770|147540770|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|90.0|0.0|0.25|||||Wilcoxon matched pair test was used to assess Food Effect for the parameter Tlag.|||0.250|0.000|
73996956|NCT03653208|147540797|OTHER||Slope|1.01||||0.1075|TWO_SIDED|90.0|||||Kruskal-Wallis|||||||0.1075
73996957|NCT03653208|147540798|OTHER||Slope|1.2||||0.0548|TWO_SIDED|90.0|||||Kruskal-Wallis|||||||0.0548
73996958|NCT03752970|147540802|OTHER||Risk Difference (RD)|-0.609|||||TWO_SIDED|95.0|-0.88|-0.186||||||||-0.186|-0.880|
73996959|NCT03752970|147540803|OTHER||Risk Difference (RD)|-0.509|||||TWO_SIDED|95.0|-0.816|-0.087||||||||-0.087|-0.816|
73996960|NCT03752970|147540804|OTHER||Risk Difference (RD)|-0.509|||||TWO_SIDED|95.0|-0.816|-0.087||||||||-0.087|-0.816|
73996961|NCT00573859|147540816|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||A 2 (ADHD medication versus Placebo) repeated measure ANOVA||||<0.05
73996962|NCT00573859|147540817|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Four-way repeated measure ANOVA||||<0.05
73996963|NCT00573859|147540818|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||Friedman's two analysis of ranks|||Friedman's two-way analysis of variance by ranks.||||<0.05
73996964|NCT05319912|147540819|OTHER||Geometric Mean Ratio (%)|75.81|||||TWO_SIDED|90.0|52.23|110.02||||||Analysis was performed using analysis of variance (ANOVA).||110.02|52.23|
73996965|NCT05319912|147540819|OTHER||Geometric Mean Ratio (%)|25.2|||||TWO_SIDED|90.0|17.21|36.89||||||Analysis was performed using ANOVA.||36.89|17.21|
73996966|NCT05319912|147540820|OTHER||Geometric Mean Ratio (%)|82.65|||||TWO_SIDED|90.0|63.91|106.9||||||Analysis was performed using ANOVA.||106.90|63.91|
73996967|NCT05319912|147540820|OTHER||Geometric Mean Ratio (%)|40.49|||||TWO_SIDED|90.0|31.12|52.68||||||Analysis was performed using ANOVA.||52.68|31.12|
73996968|NCT02229851|147540822|SUPERIORITY||Treatment difference|-1.53|||=|0.009|TWO_SIDED|95.0|-2.68|-0.38|||ANCOVA||Somapacitan-Placebo|Changes in truncal fat percentage from baseline to the 34 week's measurements was analysed using an analysis of covariance model with treatment, growth hormone deficiency (GHD) onset type, sex, region, diabetes mellitus (DM) and sex by region by DM interaction as factors and baseline as a covariate. The analysis was conducted using a multiple imputation technique where trajectory after a withdrawn subjects last observation was imputed based on data from the placebo arm.||-0.38|-2.68|=0.0090
74008554|NCT03426787|147566967|SUPERIORITY||Mean Difference (Final Values)|-12.30216|||<|0.001|TWO_SIDED|95.0|-18.95|-5.6531|||t-test, 2 sided|||||-5.6531|-18.95|<0.001
74008555|NCT03426787|147566968|SUPERIORITY||Mean Difference (Final Values)|-0.4717||||0.0463|TWO_SIDED|95.0|-0.9355|-0.00793|||t-test, 2 sided|||||-0.00793|-0.9355|0.0463
74008556|NCT03426787|147566969|SUPERIORITY||Median Difference (Final Values)|-1.936|||>|0.05|TWO_SIDED|95.0|-7.4086|3.5365|||t-test, 2 sided|||||3.5365|-7.4086|>0.05
74008557|NCT01086410|147566982|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.99|||||TWO_SIDED|95.0|0.87|1.12|||||Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.|||1.12|0.87|
74008558|NCT01086410|147566982|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.97|||||TWO_SIDED|95.0|0.86|1.1|||||Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|||1.10|0.86|
73996969|NCT00864253|147540987|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.792||||0.044|TWO_SIDED|95.1|0.631|0.992||An interim safety review was performed by DMC. An alpha spending function was utilized to preserve the overall Type 1 error at 0.050. The spending function allocated alpha of 0.001 and 0.049 to the interim and final analyses of PFS, respectively.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||Two hundred fifty-seven (257) patients were to be randomized to each treatment group for a total of 514 patients. This sample size was chosen to provide at least 80% power for the final analysis (with a two-sided type I error of 0.049) to reject the null hypothesis that the ABI 007/dacarbazine hazard ratio (HR) for PFS is equal to 1.0. This sample size calculation was based on estimates of HR = 0.750. Proportional hazards were assumed.||0.992|0.631|0.044
73996970|NCT00864253|147540988|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.831||||0.094|TWO_SIDED|99.9|0.578|1.196||At the time of the final PFS analysis, an interim analysis of survival was reported. The spending function allocated an alpha of 0.001 and 0.049 for the interim and final analysis, respectively, to preserve the overall Type I error at 0.050.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||For the participant survival, at the time at least 417 events are recorded, this sample size provides at least 80% power with a two-sided Type 1 error of 0.049 to reject the null hypothesis that the ABI-007/dacarbazine hazard ratio is equal to 1.0. This was based on a HR = 0.760. Proportional hazards were assumed.||1.196|0.578|0.094
73996971|NCT00864253|147540989|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.845||||0.086|TWO_SIDED|95.0|0.696|1.025|||Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||||1.025|0.696|0.086
73996972|NCT00864253|147540990|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.305||||0.239|TWO_SIDED|95.0|0.837|2.035|||Chi-squared|||||2.035|0.837|0.239
73996973|NCT00864253|147540991|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.442||||0.004|TWO_SIDED|95.0|1.123|1.582|||Chi-squared|||||1.582|1.123|0.004
73996974|NCT00864253|147540992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.201||||0.057|TWO_SIDED|95.0|0.959|5.053|||Log Rank|||||5.053|0.959|0.057
73996975|NCT02206061|147541078|OTHER|Repeated measure analyses testing the overall treatment effect were performed by fitting the Generalized Estimating Equation (GEE) with SFD at the three follow-up time points (3, 5, 7 months) as the dependent variable and treatment as independent variable. Normal error and identity link was specified and standard error was calculated using Sandwich estimator. Baseline SFDs, poverty level, and the presence of smokers in the home were controlled in the regression model.|Mean Difference (Net)|0.9|STANDARD_DEVIATION|2.6|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<.05
74036237|NCT00511342|147624849|SUPERIORITY_OR_OTHER_LEGACY||Difference of adjusted means|-0.078||||0.19|TWO_SIDED|95.0|-0.198|0.041||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for lumbar spine (L2-L4)|||0.041|-0.198|0.19
74036238|NCT00511342|147624849|SUPERIORITY_OR_OTHER_LEGACY||Difference of adjusted means|-0.03||||0.57|TWO_SIDED|95.0|-0.136|0.075||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for femoral neck|||0.075|-0.136|0.57
74036239|NCT01606761|147624909|SUPERIORITY_OR_OTHER||Percentage Difference|15.9|||<|0.001|TWO_SIDED|95.0|8.5|23.2|||Cochran-Mantel-Haenszel|||||23.2|8.5|< 0.001
74036240|NCT01606761|147624909|SUPERIORITY_OR_OTHER||Percentage Difference|21.0|||<|0.001|TWO_SIDED|95.0|13.6|28.5|||Cochran-Mantel-Haenszel|||||28.5|13.6|< 0.001
74036241|NCT01606761|147624910|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.251|-0.088|||ANCOVA|||||-0.088|-0.251|< 0.001
73996976|NCT01607476|147541079|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73996977|NCT01607476|147541079|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73996978|NCT01607476|147541079|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73996979|NCT01607476|147541080|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73996980|NCT01607476|147541080|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74036242|NCT01606761|147624910|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.194|||<|0.001|TWO_SIDED|95.0|-0.275|-0.112|||ANCOVA|||||-0.112|-0.275|< 0.001
74036243|NCT01606761|147624911|SUPERIORITY_OR_OTHER||Percentage Difference|12.0|||<|0.001|TWO_SIDED|95.0|6.4|17.7|||Cochran-Mantel-Haenszel|||||17.7|6.4|< 0.001
74036244|NCT01606761|147624911|SUPERIORITY_OR_OTHER||Percentage Difference|12.7|||<|0.001|TWO_SIDED|95.0|7.0|18.4|||Cochran-Mantel-Haenszel|||||18.4|7.0|< 0.001
74036245|NCT01606761|147624912|SUPERIORITY_OR_OTHER||Percentage Difference|11.0|||<|0.001|TWO_SIDED|95.0|5.5|16.5|||Cochran-Mantel-Haenszel|||||16.5|5.5|< 0.001
74036246|NCT01606761|147624912|SUPERIORITY_OR_OTHER||Percentage Difference|13.4|||<|0.001|TWO_SIDED|95.0|7.8|19.1|||Cochran-Mantel-Haenszel|||||19.1|7.8|< 0.001
74036247|NCT05086289|147624913|SUPERIORITY||Posterior Mean Difference|-0.38|||||TWO_SIDED|95.0|-0.89|0.13|||||Posterior mean difference with 95% credible interval is reported.|||0.13|-0.89|
74036248|NCT05086289|147624914|SUPERIORITY||Posterior Mean Difference|-0.28|||||TWO_SIDED|95.0|-0.85|0.3|||||Posterior mean difference with 95% credible interval is reported.|||0.30|-0.85|
74036249|NCT05086289|147624915|SUPERIORITY||Posterior Mean Difference|-0.62|||||TWO_SIDED|95.0|-1.91|0.68|||||Posterior mean difference with 95% credible interval is reported.|||0.68|-1.91|
73996981|NCT01607476|147541080|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74036250|NCT05086289|147624916|SUPERIORITY||Posterior Mean Difference|-1.17|||||TWO_SIDED|95.0|-2.54|0.18|||||Posterior mean difference with 95% credible interval is reported.|||0.18|-2.54|
74036251|NCT05086289|147624917|SUPERIORITY||Posterior Mean Difference|-0.12|||||TWO_SIDED|95.0|-0.44|0.19|||||Posterior mean difference with 95% credible interval is reported.|||0.19|-0.44|
74036252|NCT05086289|147624918|SUPERIORITY||Posterior Mean Difference|-0.26|||||TWO_SIDED|95.0|-0.67|0.14|||||Posterior mean difference with 95% credible interval is reported.|||0.14|-0.67|
74036253|NCT05086289|147624919|SUPERIORITY||Posterior Mean Difference|-0.48|||||TWO_SIDED|95.0|-1.05|0.09|||||Posterior mean difference with 95% credible interval is reported.|||0.09|-1.05|
74036254|NCT05086289|147624920|SUPERIORITY||Posterior Mean Difference|-0.51|||||TWO_SIDED|95.0|-1.17|0.16|||||Posterior mean difference with 95% credible interval is reported.|||0.16|-1.17|
73996982|NCT01114880|147541087|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
73996983|NCT01114880|147541089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
73996984|NCT01114880|147541091|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
73996985|NCT01114880|147541093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
73996986|NCT01114880|147541095|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
73996987|NCT01114880|147541097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||||||< 0.001
73996988|NCT01114880|147541099|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
73996989|NCT01114880|147541101|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
73996990|NCT01114880|147541103|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
73996991|NCT01114880|147541105|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
73996992|NCT01114880|147541107|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
73996993|NCT04655027|147541118|OTHER|Treatment effect|Difference in Estimate (LSM)|19.5|STANDARD_ERROR_OF_MEAN|15.62||0.212|TWO_SIDED|95.0|-11.155|50.15|||ANCOVA|||||50.150|-11.155|0.212
73996994|NCT04655027|147541119|OTHER|Baseline hepcidin by treatment effect|Difference in Estimate|-0.13|STANDARD_ERROR_OF_MEAN|0.17||0.441|TWO_SIDED|95.0|-0.477|0.208|||ANCOVA|||||0.208|-0.477|0.441
73996995|NCT04655027|147541119|OTHER|Baseline hs CRP by treatment effect|Difference in Estimates|-2.34|STANDARD_ERROR_OF_MEAN|3.76||0.532|TWO_SIDED|95.0|-9.707|5.017|||ANCOVA|||||5.017|-9.707|0.532
73996996|NCT04655027|147541120|OTHER|Treatment effect|Ratio of Estimates|1.09|STANDARD_ERROR_OF_MEAN|1.23||0.688|TWO_SIDED|95.0|0.723|1.635|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.635|0.723|0.688
73996997|NCT04655027|147541120|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.43|STANDARD_ERROR_OF_MEAN|0.2||0.029|TWO_SIDED|95.0|0.045|0.822|||ANCOVA|||||0.822|0.045|0.029
73996998|NCT04655027|147541120|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.568|TWO_SIDED|95.0|-0.201|0.366|||ANCOVA|||||0.366|-0.201|0.568
73996999|NCT04655027|147541121|OTHER|Treatment effect|Ratio of Estimates|0.84|STANDARD_ERROR_OF_MEAN|1.11||0.096|TWO_SIDED|95.0|0.687|1.031|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.031|0.687|0.096
73997000|NCT04655027|147541121|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.63|TWO_SIDED|95.0|-0.282|0.171|||ANCOVA|||||0.171|-0.282|0.630
73997001|NCT04655027|147541121|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.19|STANDARD_ERROR_OF_MEAN|0.08||0.015|TWO_SIDED|95.0|0.037|0.342|||ANCOVA|||||0.342|0.037|0.015
73997002|NCT04655027|147541122|OTHER|Treatment effect|Ratio of Estimates|1.23|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.123|1.354|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.354|1.123|< 0.001
73997003|NCT04655027|147541122|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.171|TWO_SIDED|95.0|-0.027|0.149|||ANCOVA|||||0.149|-0.027|0.171
73997004|NCT04655027|147541122|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.387|TWO_SIDED|95.0|-0.039|0.101|||ANCOVA|||||0.101|-0.039|0.387
73997005|NCT04655027|147541123|OTHER|Treatment effect|Ratio of Estimates|0.89|STANDARD_ERROR_OF_MEAN|1.22||0.561|TWO_SIDED|95.0|0.606|1.312|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.312|0.606|0.561
73997006|NCT04655027|147541123|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.38|STANDARD_ERROR_OF_MEAN|0.19||0.043|TWO_SIDED|95.0|0.013|0.75|||ANCOVA|||||0.750|0.013|0.043
73997007|NCT04655027|147541123|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.766|TWO_SIDED|95.0|-0.222|0.302|||ANCOVA|||||0.302|-0.222|0.766
73997008|NCT04655027|147541124|OTHER|Treatment effect|Ratio of Estimates|1.23|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.108|1.369|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.369|1.108|< 0.001
73997009|NCT04655027|147541124|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.351|TWO_SIDED|95.0|-0.059|0.159|||ANCOVA|||||0.159|-0.059|0.351
73997010|NCT04655027|147541124|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.248|TWO_SIDED|95.0|-0.031|0.114|||ANCOVA|||||0.114|-0.031|0.248
73997011|NCT04655027|147541125|OTHER|Treatment effect|Ratio of Estimates|1.29|STANDARD_ERROR_OF_MEAN|1.11||0.021|TWO_SIDED|95.0|1.043|1.598|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.598|1.043|0.021
73997012|NCT04655027|147541125|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.03|STANDARD_ERROR_OF_MEAN|0.12||0.826|TWO_SIDED|95.0|-0.276|0.223|||ANCOVA|||||0.223|-0.276|0.826
73997013|NCT04655027|147541125|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.634|TWO_SIDED|95.0|-0.212|0.132|||ANCOVA|||||0.132|-0.212|0.634
73997014|NCT04655027|147541126|OTHER|Treatment effect|Ratio of Estimates|0.45|STANDARD_ERROR_OF_MEAN|1.31||0.007|TWO_SIDED|95.0|0.257|0.786|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||0.786|0.257|0.007
73997015|NCT04655027|147541126|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.16|STANDARD_ERROR_OF_MEAN|0.31||0.61|TWO_SIDED|95.0|-0.798|0.48|||ANCOVA|||||0.480|-0.798|0.610
73997016|NCT04655027|147541126|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.07|STANDARD_ERROR_OF_MEAN|0.22||0.74|TWO_SIDED|95.0|-0.387|0.536|||ANCOVA|||||0.536|-0.387|0.740
73997017|NCT00186888|147541149|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportion|88.9|||||TWO_SIDED|95.0|71.3|96.9||||||||96.9|71.3|
73997018|NCT00186888|147541150|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportion|91.7|||||TWO_SIDED|95.0|65.1|99.6||||||||99.6|65.1|
73997019|NCT00186888|147541151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.452||95.0|||||ANOVA|||CYP3A4\*1B: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.452
73997020|NCT00186888|147541151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.106||95.0|||||ANOVA|||CYP3A5\*3: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.106
73997021|NCT00186888|147541152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||95.0|||||ANOVA|||BCRP 1143: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.245
73997022|NCT00186888|147541152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0|||||ANOVA|||BCRP 15622: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.297
73997023|NCT00186888|147541152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||95.0|||||ANOVA|||BCRP Exon 2: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.372
73997024|NCT00186888|147541152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.844||95.0|||||ANOVA|||BCRP Exon 5: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.844
73997025|NCT00186888|147541152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.616||95.0|||||ANOVA|||Pgp Exon 21: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.616
74036255|NCT05086289|147624921|SUPERIORITY||Posterior Mean Difference|-4.95|||||TWO_SIDED|95.0|-11.07|1.27|||||Posterior mean difference with 95% credible interval is reported.|||1.27|-11.07|
74036256|NCT05086289|147624922|SUPERIORITY||Posterior Mean Difference|-4.78|||||TWO_SIDED|95.0|-11.73|2.15|||||Posterior mean difference with 95% credible interval is reported.|||2.15|-11.73|
74036257|NCT05086289|147624923|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.46|0.21|||||Posterior mean difference with 95% credible interval is reported.|||0.21|-0.46|
74036258|NCT05086289|147624924|SUPERIORITY||Posterior Mean Difference|1.52|||||TWO_SIDED|95.0|-6.2|9.2|||||Posterior mean difference with 95% credible interval is reported.|||9.20|-6.20|
74036259|NCT05086289|147624925|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.06|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.06|
74036260|NCT05086289|147624926|SUPERIORITY||Posterior Mean Difference|0.02|||||TWO_SIDED|95.0|-0.05|0.1|||||Posterior mean difference with 95% credible interval is reported.|||0.10|-0.05|
74036261|NCT05086289|147624927|SUPERIORITY||Posterior Mean Difference|41.72|||||TWO_SIDED|95.0|-95.92|179.76|||||Posterior mean difference with 95% credible interval is reported.|||179.76|-95.92|
74036262|NCT05086289|147624928|SUPERIORITY||Posterior Mean Difference|9.73|||||TWO_SIDED|95.0|-151.11|170.52|||||Posterior mean difference with 95% credible interval is reported.|||170.52|-151.11|
74036263|NCT03150108|147624935|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% confidence interval (CI).|Geometric mean ratio|1.119|||||TWO_SIDED|90.0|0.875|1.43||||||||1.430|0.875|
73997026|NCT00186888|147541152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.424||95.0|||||ANOVA|||Pgp Exon 26: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.424
73997027|NCT02344290|147541193|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.48|0.84|||||Hazard ratio is shown as pitavastatin/placebo. Two-sided 95% repeated confidence interval that adjusts for interim looks according to the realized Lan and DeMets implementation of the O'Brien-Fleming sequential stopping boundary is presented.|||0.84|0.48|
73997028|NCT02344290|147541194|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.36|0.87|||||Hazard ratio is shown as pitavastatin/placebo.|||0.87|0.36|
73997029|NCT02344290|147541195|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.4|0.97|||||Hazard ratio is shown as pitavastatin/placebo.|||0.97|0.40|
73997030|NCT02344290|147541196|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.11|4.02|||||Hazard ratio is shown as pitavastatin/placebo.|||4.02|0.11|
74036264|NCT03150108|147624935|OTHER|Dose proportionality|Increase in Cmax per Dose Doubling|1.76|||||TWO_SIDED|90.0|1.52|2.03|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted Cmax using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.03|1.52|
73997031|NCT02344290|147541197|SUPERIORITY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.35|1.38|||||Hazard ratio is shown as pitavastatin/placebo.|||1.38|0.35|
73997032|NCT02344290|147541198|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||Hazard ratio is shown as pitavastatin/placebo.|||1.03|0.44|
73997033|NCT02344290|147541199|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.36|1.05|||||||Hazard ratio is shown as pitavastatin/placebo.|1.05|0.36|
73997034|NCT02344290|147541201|SUPERIORITY||Hazard Ratio (HR)|0.0|||||TWO_SIDED|95.0|0.0|0.54|||||||Hazard ratio is shown as pitavastatin/placebo. Estimation of the confidence interval used a Bayes analysis with a non-informative prior using adaptive rejection Metropolis sampling. In this case, the interval shown is a 95% highest posterior density (HPD) interval.|0.54|0.00|
73997035|NCT02344290|147541202|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.64|0.94|||||Hazard ratio is shown as pitavastatin/placebo.|||0.94|0.64|
73997036|NCT02344290|147541203|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.7|1.12|||||Hazard ratio is shown as pitavastatin/placebo.|||1.12|0.70|
74036265|NCT03150108|147624937|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUClast values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.8|1.23||||||||1.23|0.80|
74036266|NCT03150108|147624937|OTHER|Dose proportionality|Increase in AUClast per Dose Doubling|2.35||||||90.0|2.06|2.7|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUClast using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.70|2.06|
73997037|NCT02344290|147541204|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.76|1.13|||||Hazard ratio is shown as pitavastatin/placebo.|||1.13|0.76|
73997038|NCT02344290|147541205|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.71|1.2|||||Hazard ratio is shown as pitavastatin/placebo.|||1.20|0.71|
73997039|NCT02344290|147541206|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.68|1.31|||||Hazard ratio is shown as pitavastatin/placebo.|||1.31|0.68|
73997040|NCT02344290|147541207|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.14|2.51|||||Hazard ratio is shown as pitavastatin/placebo.|||2.51|0.14|
73997041|NCT02344290|147541208|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.42|2.02|||||Hazard ratio is shown as pitavastatin/placebo.|||2.02|0.42|
73997042|NCT02344290|147541209|SUPERIORITY||Incidence rate ratio|1.0|||||TWO_SIDED|95.0|0.9|1.1|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.10|0.90|
73997043|NCT02344290|147541210|SUPERIORITY||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|1.07|1.57|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.57|1.07|
73997044|NCT02344290|147541211|SUPERIORITY||Incidence rate ratio|1.58|||||TWO_SIDED|95.0|1.14|2.19|||||Incidence rate ratio is shown as pitavastatin/placebo.|||2.19|1.14|
73997045|NCT02344290|147541212|SUPERIORITY||Incidence rate ratio|0.75|||||TWO_SIDED|95.0|0.17|3.37|||||Incidence rate ratio is shown as pitavastatin/placebo.|||3.37|0.17|
73997046|NCT02344290|147541213|SUPERIORITY||Incidence rate ratio|1.34|||||TWO_SIDED|95.0|0.56|3.18|||||Incidence rate ratio is shown as pitavastatin/placebo.|||3.18|0.56|
73997047|NCT02344290|147541214|SUPERIORITY||Incidence rate ratio|1.04|||||TWO_SIDED|95.0|0.97|1.12|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.12|0.97|
73997048|NCT02344290|147541217|SUPERIORITY||Incidence rate ratio|0.75|||||TWO_SIDED|95.0|0.52|1.08|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.08|0.52|
73997049|NCT02344290|147541218|SUPERIORITY||Incidence rate ratio|1.05|||||TWO_SIDED|95.0|0.96|1.16|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.16|0.96|
73997050|NCT02344290|147541219|SUPERIORITY||Mean Difference (Net)|-4.3||||0.04|TWO_SIDED|95.0|-8.6|-0.1|||Regression, Linear||Treatment group difference was estimated as baseline-adjusted mean difference in change at year 2, using linear regression.|||-0.1|-8.6|0.04
73997051|NCT02344290|147541220|SUPERIORITY||Risk Ratio (RR)|0.67||||0.003|TWO_SIDED|95.0|0.52|0.88|||Chi-squared||Treatment effect was estimated as relative risk (pitavastatin/placebo), adjusted for presence of NCP at entry.|||0.88|0.52|0.003
73997052|NCT02344290|147541221|SUPERIORITY||Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-9.2|0.62|||||Treatment group difference was estimated as baseline-adjusted difference in mean change at year 2, using linear regression.|||0.62|-9.2|
73997053|NCT02344290|147541222|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of LpPla2 Levels at Month 24||||<0.001
73997054|NCT02344290|147541223|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in LpPla2 from Baseline at Month 24||||<0.001
73997055|NCT02344290|147541224|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Comparison of hsCRP Levels at Month 24||||0.02
73997056|NCT02344290|147541225|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in hsCRP from Baseline at Month 24||||0.09
73997057|NCT02344290|147541226|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Comparison of soluble CD163 Levels at Month 24.||||0.65
73997058|NCT02344290|147541227|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in soluble CD163 from Baseline at Month 24||||0.88
73997059|NCT02344290|147541228|SUPERIORITY|||||||0.98|||||||Regression, Cox|Treatment effect modification by sex was evaluated via interaction of treatment and sex in the Cox proportional hazards regression model.||Evaluation of treatment effect modification by sex (i.e. pitavastatin effect differing in females compared to males).||||0.98
73997060|NCT02344290|147541228|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.39|1.04|||||Hazard ratio is shown as pitavastatin/placebo among females.|Evaluation of pitavastatin effect among females.||1.04|0.39|
73997061|NCT02344290|147541228|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.48|0.86|||||Hazard ratio is shown as pitavastatin/placebo among males.|Evaluation of pitavastatin effect among males.||0.86|0.48|
73997062|NCT02344290|147541229|SUPERIORITY|||||||0.14|||||||Regression, Cox|Treatment effect modification by race was evaluated via interaction of treatment and race in the Cox proportional hazards regression model.||Evaluation of treatment effect modification by race (i.e. pitavastatin effect differing between races).||||0.14
73997063|NCT02344290|147541229|SUPERIORITY||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.09|0.59||||||Pitavastatin effect among Asians from subgroup analysis by race.|Hazard ratio is shown as pitavastatin/placebo among Asians.|0.59|0.09|
73997064|NCT02344290|147541229|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.46|0.96|||||Hazard ratio is shown as pitavastatin/placebo among Blacks.|Pitavastatin effect among Blacks from subgroup analysis by race.||0.96|0.46|
73997065|NCT02344290|147541229|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.49|1.13|||||Hazard ratio is shown as pitavastatin/placebo among Whites.|Pitavastatin effect among Whites from subgroup analysis by race.||1.13|0.49|
73997066|NCT02344290|147541229|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.36|2.1||||||Pitavastatin effect among Other race from subgroup analysis by race.|Hazard ratio is shown as pitavastatin/placebo among Other race.|2.10|0.36|
73997067|NCT03826030|147541230|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||The null hypothesis was no overall difference in FM-UE scale change between the three groups on day 15. The change in FM-UE was modelled using a linear mixed-effects repeated measures model adjusted for visit (ie, day 15, day 45, and day 105), treatment group, treatment group by visit interaction, baseline FM-UE, time from stroke (30-90 vs. 91-180 days), and enrolment site. An AR(1) autocorrelation structure was used for visit, and variance components structure for sites.||||0.39
73997068|NCT01325311|147541352|SUPERIORITY_OR_OTHER|||||||0.922|TWO_SIDED||||||t-test, 2 sided|||Using the Student t-test. If the normality assumption is tenuous, an appropriate transformation of the data such as logarithm will be considered for Student t-test or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison.||||0.922
73997069|NCT00384774|147541373|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Headache Response||||1.0000
73997070|NCT00384774|147541373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0991|||||||Fisher Exact|||Headache Response||||0.0991
73997071|NCT00384774|147541373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4851|||||||Chi-squared|||Headache Response||||0.4851
73997072|NCT00384774|147541373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1178|||||||Chi-squared|||Headache Response||||0.1178
73997073|NCT00384774|147541373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1093|||||||Chi-squared|||Headache Response||||0.1093
73997074|NCT00384774|147541373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3364|||||||Fisher Exact|||Headache Response||||0.3364
73997075|NCT00568178|147541388|SUPERIORITY_OR_OTHER_LEGACY||Ratio in Geometric Mean|0.63||||0.001|TWO_SIDED|95.0|0.54|0.74|||Mixed Models Analysis|||||0.74|0.54|0.001
73997076|NCT00568178|147541389|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4||||||95.0|-9.9|-1.0|||Mixed Models Analysis|||||-1.0|-9.9|
73997077|NCT00568178|147541390|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6||||||95.0|-9.2|-0.1|||Mixed Models Analysis|||||-0.1|-9.2|
73997078|NCT00568178|147541391|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio|1.18|||||TWO_SIDED|95.0|0.86|1.6||No P Value was calculated for this outcome.|Mixed Models Analysis|An unstructured variance-covariance was used.||||1.60|0.86|
73997079|NCT00568178|147541392|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-3.8||||||95.0|-15.2|7.6||A P-Value was not calculated for this outcome.|Mixed Models Analysis|||||7.6|-15.2|
73997080|NCT01531673|147541394|SUPERIORITY||Least Squares (LS) Mean Difference|4.77||||0.0647|TWO_SIDED|95.0|-0.3|9.84|||Mixed-effect repeated measure (MMRM)|||||9.84|-0.3|0.0647
73997081|NCT01531673|147541394|SUPERIORITY||LS Mean Difference|-3.91||||0.1686|TWO_SIDED|95.0|-9.5|1.68|||MMRM|||||1.68|-9.5|0.1686
73997082|NCT01531673|147541394|SUPERIORITY||LS Mean Difference|-4.2||||0.0348|TWO_SIDED|95.0|-8.1|-0.31|||MMRM|||||-0.31|-8.1|0.0348
73997083|NCT01531673|147541394|SUPERIORITY||LS Mean Difference|-19.58|||<|0.0001|TWO_SIDED|95.0|-24.57|-14.59|||MMRM|||||-14.59|-24.57|<0.0001
73997084|NCT01531673|147541394|SUPERIORITY||LS Mean Difference|-5.14||||0.0101|TWO_SIDED|95.0|-9.03|-1.25|||MMRM|||||-1.25|-9.03|0.0101
73997085|NCT01531673|147541394|SUPERIORITY||LS Mean Difference|-5.19||||0.011|TWO_SIDED|95.0|-9.16|-1.21|||MMRM|||||-1.21|-9.16|0.011
73997086|NCT01531673|147541394|SUPERIORITY||LS Mean Difference|-9.6||||0.0001|TWO_SIDED|95.0|-14.38|-4.82|||MMRM|||||-4.82|-14.38|0.0001
73997087|NCT01531673|147541394|SUPERIORITY||LS Mean Difference|-1.77||||0.3745|TWO_SIDED|95.0|-5.71|2.17|||MMRM|||||2.17|-5.71|0.3745
73997088|NCT01531673|147541395|SUPERIORITY||LS Mean Difference|-6.7||||0.0357|TWO_SIDED|95.0|-12.94|-0.46|||MMRM|||||-0.46|-12.94|0.0357
73997089|NCT01531673|147541396|SUPERIORITY||LS Mean Difference|-17.2||||0.0238|TWO_SIDED|95.0|-31.75|-2.65|||MMRM|||||-2.65|-31.75|0.0238
73997090|NCT00264303|147541411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.005||95.0|0.08|0.43|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate.||||0.43|0.08|0.005
73997091|NCT00264303|147541412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.041||95.0|0.01|0.34|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate||||0.34|0.01|0.041
73997092|NCT00264303|147541413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.004||95.0|0.04|0.22|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus severity score as covariate.||||0.22|0.04|0.004
73997093|NCT00264303|147541414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.002||95.0|0.06|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus duration as covariate.||||0.26|0.06|0.002
73997094|NCT00264303|147541415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.009||95.0|0.03|0.22|||ANCOVA|ANCOVA with treatment and pooled centers as factors and baseline pruritus duration score as covariate.||||0.22|0.03|0.009
73997095|NCT00264303|147541416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|||<|0.001||95.0|0.07|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline severity as covariate.||The primary hypothesis to be tested in this study was that the clinical efficacy of Levocetirizine 5 mg is superior to that of Desloratidine 5 mg||0.26|0.07|<0.001
73997096|NCT02815579|147541417|SUPERIORITY||Difference in log odds|-0.08||||0.86|TWO_SIDED|95.0|-1.0|0.84|||Mixed Models Analysis|||The investigators produced a difference-in-difference estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.84|-1.0|0.86
73997097|NCT02815579|147541418|SUPERIORITY||Difference in log odds|0.32||||0.23|TWO_SIDED|95.0|-0.28|0.92|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.92|-0.28|0.23
73997098|NCT02815579|147541419|SUPERIORITY||Mean Difference (Net)|1.39||||0.26|TWO_SIDED|95.0|-1.01|3.78|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||3.78|-1.01|0.26
73997099|NCT02815579|147541420|SUPERIORITY||Difference in log odds|0.84||||0.31|TWO_SIDED|95.0|-0.79|2.47|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||2.47|-0.79|0.31
73997100|NCT02815579|147541421|SUPERIORITY||Difference in log odds|-0.34||||0.44|TWO_SIDED|95.0|-1.22|0.53|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.53|-1.22|0.44
73997101|NCT02815579|147541422|SUPERIORITY||Mean Difference (Net)|-3.54|||<|0.001|TWO_SIDED|95.0|-4.16|-2.92|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-2.92|-4.16|<0.001
73997102|NCT02815579|147541423|SUPERIORITY||Mean Difference (Net)|-0.21||||0.02|TWO_SIDED|95.0|-0.39|-0.04|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-0.04|-0.39|0.02
73997103|NCT02815579|147541424|SUPERIORITY||Mean Difference (Net)|0.01||||0.98|TWO_SIDED|95.0|-0.82|0.84|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||0.84|-0.82|0.98
73997104|NCT02815579|147541425|SUPERIORITY||Mean Difference (Net)|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-0.15|-0.59|0.001
73997105|NCT02815579|147541426|SUPERIORITY||Difference in log odds|-0.83||||0.001|TWO_SIDED|95.0|-1.45|-0.2|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||-0.20|-1.45|0.001
73997106|NCT02815579|147541427|SUPERIORITY||Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.52|-0.31|||Mixed Models Analysis|||||-0.31|-0.52|<0.001
73997107|NCT02389452|147541428|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
73997108|NCT02311673|147541446|OTHER||Least Squares (LS) Mean Difference|-0.3||||0.42|TWO_SIDED|95.0|-3.1|2.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.5|-3.1|0.420
73997109|NCT02311673|147541446|OTHER||LS Mean Difference|-0.4||||0.348|TWO_SIDED|95.0|-2.3|1.6|||Longitudinal mixed analysis of variance|One sided p-value.|A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.6|-2.3|0.348
73997110|NCT02311673|147541446|OTHER||LS Mean Difference|0.8||||0.779|TWO_SIDED|95.0|-1.3|2.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.9|-1.3|0.779
73997111|NCT02311673|147541448|OTHER||LS Mean Difference|21.5||||0.901|TWO_SIDED|95.0|-11.8|54.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||54.8|-11.8|0.901
73997112|NCT02311673|147541448|OTHER||LS Mean Difference|-3.9||||0.362|TWO_SIDED|95.0|-26.3|18.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||18.5|-26.3|0.362
73997113|NCT02311673|147541448|OTHER||LS Mean Difference|-3.7||||0.378|TWO_SIDED|95.0|-28.0|20.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||20.5|-28.0|0.378
73997114|NCT02311673|147541449|OTHER||LS Mean Difference|20.6||||0.84|TWO_SIDED|95.0|-20.9|62.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||62.2|-20.9|0.840
73997115|NCT02311673|147541449|OTHER||LS Mean Difference|-10.2||||0.236|TWO_SIDED|95.0|-38.7|18.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||18.4|-38.7|0.236
73997116|NCT02311673|147541449|OTHER||LS Mean Difference|-13.4||||0.191|TWO_SIDED|95.0|-44.2|17.4|||Longitudinal mixed analysis of variance|One sided p-value.||||17.4|-44.2|0.191
73997117|NCT02311673|147541450|OTHER||LS Mean Difference|19.5||||0.812|TWO_SIDED|95.0|-24.8|63.8||One sided p-value.|Longitudinal mixed analysis of variance||||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|63.8|-24.8|0.812
73997118|NCT02311673|147541450|OTHER||LS Mean Difference|-1.3||||0.464|TWO_SIDED|95.0|-29.9|27.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||27.4|-29.9|0.464
73997119|NCT02311673|147541450|OTHER||LS Mean Difference|-2.6||||0.432|TWO_SIDED|95.0|-33.6|28.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||28.4|-33.6|0.432
73997120|NCT02311673|147541451|OTHER||LS Mean Difference|49.9||||0.988|TWO_SIDED|95.0|6.7|93.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||93.2|6.7|0.988
73997121|NCT02311673|147541451|OTHER||LS Mean Difference|16.0||||0.859|TWO_SIDED|95.0|-13.7|45.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||45.6|-13.7|0.859
73997122|NCT02311673|147541451|OTHER||LS Mean Difference|22.2||||0.916|TWO_SIDED|95.0|-9.8|54.3||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||54.3|-9.8|0.916
73997123|NCT02311673|147541452|OTHER||LS Mean Difference|32.7||||0.943|TWO_SIDED|95.0|-8.4|73.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||73.8|-8.4|0.943
73997124|NCT02311673|147541452|OTHER||LS Mean Difference|-4.2||||0.339|TWO_SIDED|95.0|-24.4|16.1||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||16.1|-24.4|0.339
73997125|NCT02311673|147541452|OTHER||LS Mean Difference|1.1||||0.533|TWO_SIDED|95.0|-25.0|27.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||27.2|-25.0|0.533
73997126|NCT02311673|147541460|OTHER||LS Mean Difference|-0.2||||0.439|TWO_SIDED|95.0|-3.0|2.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.6|-3.0|0.439
73997127|NCT02311673|147541460|OTHER||LS Mean Difference|-0.3||||0.366|TWO_SIDED|95.0|-2.3|1.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.6|-2.3|0.366
73997128|NCT02311673|147541460|OTHER||LS Mean Difference|0.7||||0.744|TWO_SIDED|95.0|-1.4|2.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.8|-1.4|0.744
73997129|NCT02311673|147541461|OTHER||LS Mean Difference|1.0||||0.883|TWO_SIDED|95.0|-0.7|2.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.8|-0.7|0.883
73997130|NCT02311673|147541461|OTHER||LS Mean Difference|-0.2||||0.338|TWO_SIDED|95.0|-1.3|0.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||0.9|-1.3|0.338
73997131|NCT02311673|147541461|OTHER||LS Mean Difference|-0.2||||0.381|TWO_SIDED|95.0|-1.6|1.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.2|-1.6|0.381
73997132|NCT02311673|147541463|OTHER||LS Mean Difference|1.3||||0.679|TWO_SIDED|95.0|-4.5|7.0||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||7.0|-4.5|0.679
73997133|NCT02311673|147541463|OTHER||LS Mean Difference|0.7||||0.641|TWO_SIDED|95.0|-3.3|4.7||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||4.7|-3.3|0.641
73997134|NCT02311673|147541463|OTHER||LS Mean Difference|1.9||||0.809|TWO_SIDED|95.0|-2.6|6.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||6.4|-2.6|0.809
73997135|NCT02311673|147541464|OTHER||LS Mean Difference|0.5||||0.633|TWO_SIDED|95.0|-2.6|3.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||3.6|-2.6|0.633
73997136|NCT02311673|147541464|OTHER||LS Mean Difference|0.1||||0.528|TWO_SIDED|95.0|-2.1|2.3||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.3|-2.1|0.528
73997137|NCT02311673|147541464|OTHER||LS Mean Difference|0.5||||0.648|TWO_SIDED|95.0|-2.0|2.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.9|-2.0|0.648
73997138|NCT02311673|147541466|OTHER||LS Mean Difference|0.7||||0.712|TWO_SIDED|95.0|-1.8|3.1||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||3.1|-1.8|0.712
73997139|NCT02311673|147541466|OTHER||LS Mean Difference|-0.2||||0.414|TWO_SIDED|95.0|-1.9|1.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.5|-1.9|0.414
73997140|NCT02311673|147541466|OTHER||LS Mean Difference|0.6||||0.732|TWO_SIDED|95.0|-1.3|2.5||One sided p-value|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.5|-1.3|0.732
73997141|NCT01006252|147541468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|||||||0.121
73997142|NCT01006252|147541469|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.048||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|Analysis adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group||||||0.048
73997143|NCT01006252|147541470|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates||||||0.396
73876871|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|16.3||||0.477|TWO_SIDED|95.0|-18.6|51.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||51.1|-18.6|0.477
73997144|NCT01006252|147541472|SUPERIORITY_OR_OTHER|||||||0.483||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates.||||||0.483
73997145|NCT01006252|147541473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.505||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|||||||0.505
73997146|NCT01006252|147541474|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.902
73997147|NCT01006252|147541474|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.970
73997148|NCT01006252|147541476|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.902
73997149|NCT01006252|147541476|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||P-value given for Overall Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.970
73997150|NCT01006252|147541477|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.547
73997151|NCT01006252|147541477|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.414
73997152|NCT01006252|147541479|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.547
73997153|NCT01006252|147541479|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.414
73997154|NCT02683772|147541511|NON_INFERIORITY|The method proposed for this analysis was a one-sided paired t-test using a significance level of 0.05 and a non-inferiority margin of 2 events/hour|Mean Difference (Final Values)|-4.45|STANDARD_DEVIATION|17.23||0.0134|TWO_SIDED||||||t-test, 1 sided|||||||0.0134
73997155|NCT00414908|147541519|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.||||<0.0001
73997156|NCT00414908|147541520|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.||||0.0002
73997157|NCT00414908|147541521|SUPERIORITY_OR_OTHER||LS Means difference|-112.45|||<|0.0001||95.0|-147.04|-77.87|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool fat at baseline as a covariate."||-77.87|-147.04|<0.0001
73997158|NCT00414908|147541522|SUPERIORITY_OR_OTHER||LS Means difference|-11.68|||<|0.0001||95.0|-17.3|-6.06|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo. For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool nitrogen at baseline as a covariate."||-6.06|-17.30|<0.0001
73997159|NCT00414908|147541523|SUPERIORITY_OR_OTHER||LS Means difference|-0.76||||0.005||95.0|-1.27|-0.24|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal). The hypothesis was to show superior efficacy of pancrelipase capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool frequency at baseline as a covariate."||-0.24|-1.27|0.005
73997160|NCT00414908|147541527|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|Mean difference based on all subjects combined using the paired t-test between baseline and visit 8 or early termination||||||<0.001
73997161|NCT00921687|147541560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.04|TWO_SIDED|95.0|1.01|2.3|||Generalized Estimating Equation||Intervention clinic (vs control clinic)|||2.30|1.01|0.04
73997162|NCT00921687|147541561|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.44||95.0|0.84|1.49|||Generalized Estimating Equation||Intervention clinic (vs control clinic)|||1.49|0.84|0.44
73997163|NCT00316602|147541565|NON_INFERIORITY|The non-inferiority margin to show that Group 2 (Atopic Dermatitis Participants) is non-inferior to Group 1 (Healthy Participants) in terms of seroconversion rate at Week 6 was predefined as -5% for the difference in seroconversion rates.|Difference in seroconversion rates (%)|-1.2|||||ONE_SIDED|97.5|-4.3||||||||||-4.3|
73997164|NCT00626990|147541581|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.76|TWO_SIDED|99.1|0.73|1.28|||Regression, Cox|||||1.28|0.73|0.76
73997165|NCT00626990|147541581|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.79|||Regression, Cox|||||0.79|0.52|<0.0001
73997166|NCT00626990|147541582|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.11|TWO_SIDED|95.0|0.72|1.03|||Regression, Cox|||||1.03|0.72|0.11
73997167|NCT00626990|147541582|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.49|0.7|||Regression, Cox|||||0.70|0.49|<0.0001
73997168|NCT00297427|147541615|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
73997169|NCT00297427|147541616|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 2 sided|||||||0.32
73997170|NCT00297427|147541617|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.16
73997171|NCT00297427|147541618|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.18
73997172|NCT00297427|147541620|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
73997173|NCT00297427|147541621|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.38
73997174|NCT00297427|147541622|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.43
73997175|NCT00297427|147541624|SUPERIORITY_OR_OTHER|||||||0.04|||||||Repeated measures using GEE|||||||0.04
73997176|NCT00297427|147541625|SUPERIORITY_OR_OTHER|||||||0.01|||||||Repeated measures using GEE|||||||0.01
73997177|NCT00297427|147541626|SUPERIORITY_OR_OTHER|||||||0.41|||||||Repeated measures using GEE|||||||0.41
73997178|NCT00297427|147541627|SUPERIORITY_OR_OTHER|||||||0.04||||||Bivariate (unadjusted) analysis|t-test, 2 sided|||||||0.04
73997179|NCT00297427|147541627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.208||||0.014|TWO_SIDED|95.0|1.039|1.405|||Regression, Logistic||These are the adjusted results of a multivariate logistic regression.|||1.405|1.039|0.014
73997180|NCT00297427|147541628|SUPERIORITY_OR_OTHER|||||||0.023||||||This is the result from the bivariate (unadjusted) analysis.|t-test, 2 sided|||||||0.023
73997181|NCT00297427|147541628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.936||||0.03|TWO_SIDED|95.0|0.881|0.994|||Regression, Logistic||These are the adjusted results from a multivariate logistic regression analysis.|||0.994|0.881|0.030
73997182|NCT00297427|147541629|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
73997183|NCT00297427|147541630|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
73997184|NCT00297427|147541632|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<.001
73997185|NCT00297427|147541633|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
73997186|NCT00297427|147541634|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||||||0.86
73997187|NCT02787044|147541641|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.21|TWO_SIDED|95.0|0.97|1.17|||Regression, Cox|||Note, each participant can be included in the primary analysis up to 3 times (participating seasons).||1.17|0.97|0.21
73997188|NCT02787044|147541642|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.44|TWO_SIDED|95.0|0.94|1.15|||Regression, Cox|||||1.15|0.94|0.44
73997189|NCT02787044|147541643|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.16|TWO_SIDED|95.0|0.97|1.2|||Regression, Cox|||Each participant can be analyzed up to three times (seasons)||1.2|.97|0.16
73997190|NCT02787044|147541644|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.26|TWO_SIDED|95.0|0.96|1.15|||Regression, Cox|||||1.15|.96|0.26
73997191|NCT02787044|147541645|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96|TWO_SIDED|95.0|0.84|1.21|||Regression, Cox|||||1.21|0.84|0.96
73997192|NCT04155047|147541680|SUPERIORITY||Least Squares Mean Difference|-0.323|STANDARD_ERROR_OF_MEAN|0.1861||0.0987|TWO_SIDED|95.0|-0.711|0.066|||Mixed Models Analysis|||||0.066|-0.711|0.0987
73997193|NCT03361605|147541683|SUPERIORITY|"Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the Superiority indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli."|Mean Difference (Net)|-0.349|STANDARD_DEVIATION|0.223|<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = BOLD Response During Sedation - BOLD Response During Baseline|The null hypothesis is no difference in BOLD response between sedated state and baseline.||||<0.0001
73997194|NCT03361605|147541684|SUPERIORITY|"Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the Superiority indicates if propofol administration has a statistically significant impact on the squeeze pressure in response to verbal instructions."|Mean Difference (Net)|-2.16|STANDARD_DEVIATION|3.09||0.00148|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline|The null hypothesis is no difference in squeeze pressure between sedated state and baseline.||||0.00148
73997195|NCT02003222|147541707|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.003|TWO_SIDED|95.0|0.25|0.76|||Log Rank||hazard ratio: blinatumomab + chemotherapy vs. chemotherapy alone|||0.76|0.25|0.003
73997196|NCT02003222|147541708|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.015|TWO_SIDED|95.0|0.31|0.89|||Log Rank||hazard ratio: Blinatumomab + Chemotherapy vs. Chemotherapy alone|||0.89|0.31|0.015
73997197|NCT02003222|147541709|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.67|TWO_SIDED|95.0|0.22|2.65|||Log Rank|||||2.65|0.22|0.67
73997198|NCT02003222|147541710|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.28|3.63|||Log Rank|||||3.63|0.28|1.00
73997199|NCT02003222|147541711|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.41|TWO_SIDED|95.0|0.17|2.11|||Log Rank||hazard ratio: blinatumomab + chemotherapy vs. chemotherapy alone|||2.11|0.17|0.41
73997200|NCT00403767|147541733|NON_INFERIORITY_OR_EQUIVALENCE|Alternative hypothesis of non-inferiority (NI) by a NI margin of 1.46 in hazard ratio (HR) based on on-treatment data from the per protocol population. The required number of primary efficacy endpoint events was determined based on the following assumptions: NI margin of 1.46, 1-sided alpha of 0.025, power of \>95% when true HR is 1, and exponential distributions. The margin was selected based on clinical appropriateness and quantitative analysis of relevant studies in Hart et al.|Hazard Ratio (HR)|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.025 (1-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||||0.96|0.66|<0.001
73997201|NCT00403767|147541734|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.015|TWO_SIDED|95.0|0.65|0.95||The p-value Is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.95|0.65|0.015
73997202|NCT00403767|147541735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.442|TWO_SIDED|95.0|0.96|1.11||The p-value is not adjusted for mulitple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternate hypothesis of superiority based on on-treatment data from the safety population.||1.11|0.96|0.442
73997203|NCT00403767|147541736|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.034|TWO_SIDED|95.0|0.74|0.99||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.99|0.74|0.034
73997204|NCT00403767|147541737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.01|TWO_SIDED|95.0|0.74|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.96|0.74|0.010
73997205|NCT00403767|147541738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.092|TWO_SIDED|95.0|0.7|1.03||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.03|0.70|0.092
73997206|NCT00403767|147541739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.23||||0.003|TWO_SIDED|95.0|0.09|0.61||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.61|0.09|0.003
73997207|NCT00403767|147541740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.121|TWO_SIDED|95.0|0.63|1.06||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.06|0.63|0.121
73997208|NCT00403767|147541741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.289|TWO_SIDED|95.0|0.73|1.1||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.10|0.73|0.289
73997209|NCT00403767|147541742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.073|TWO_SIDED|95.0|0.7|1.02||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.02|0.70|0.073
73997210|NCT01696955|147541743|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
73997211|NCT01696955|147541746|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
73997212|NCT01696955|147541747|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
73997213|NCT01696955|147541748|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
73997214|NCT03192475|147541752|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
73997215|NCT03192475|147541753|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
73997216|NCT03192475|147541754|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
73997217|NCT03192475|147541755|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
73997218|NCT03192475|147541756|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
73997219|NCT03192475|147541757|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|||||||0.53
73997220|NCT03192475|147541758|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
73997221|NCT03192475|147541759|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||||||0.60
73997222|NCT03192475|147541760|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
73997223|NCT03192475|147541761|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
73997224|NCT03192475|147541762|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
73997225|NCT03192475|147541763|SUPERIORITY|||||||0.0009|||||||Mantel Haenszel|||||||0.0009
73997226|NCT03192475|147541764|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||0.18
73997227|NCT03192475|147541765|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.34
73997228|NCT03192475|147541766|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
73997229|NCT01204710|147541805|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.29||||0.2201|TWO_SIDED|95.0|0.87|1.9||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as IMC-3G3 + Mitoxantrone / Mitoxantrone and estimated from Cox model.|||1.90|0.87|0.2201
73997230|NCT01204710|147541806|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.7291|TWO_SIDED|95.0|0.72|1.61||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as Olaratumab + Mitoxantrone / Mitoxantrone and estimated from Cox model.|||1.61|0.72|0.7291
73997231|NCT01204710|147541807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3465|TWO_SIDED||||||Fisher Exact|||||||0.3465
73997232|NCT01204710|147541808|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6571|TWO_SIDED||||||Fisher Exact|||||||0.6571
73997233|NCT01204710|147541809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4986|TWO_SIDED||||||Fisher Exact|||||||0.4986
73997234|NCT01276379|147541817|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.004|TWO_SIDED|95.0|1.23|3.29|||Log Rank|||||3.29|1.23|0.004
73997235|NCT01276379|147541818|SUPERIORITY||Hazard Ratio (HR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.33|3.96|||Log Rank|||||3.96|1.33|<0.0001
73997236|NCT02001064|147541839|SUPERIORITY||Odds Ratio (OR)|2.3||||0.32|TWO_SIDED||||||t-test, 1 sided|||||||0.32
73997237|NCT02001064|147541840|SUPERIORITY|||||||0.073||||||Cohen's d (ranks) = -.049|Wilcoxon (Mann-Whitney)|||||||0.073
73997238|NCT02001064|147541841|SUPERIORITY|||||||0.24||||||Cohen's d=0.31|Wilcoxon (Mann-Whitney)|||||||0.24
73997239|NCT01732822|147541880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.65|TWO_SIDED|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.13|0.92|0.650
73997240|NCT01732822|147541881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.738|TWO_SIDED|95.0|0.92|1.12||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.12|0.92|0.738
73997241|NCT01732822|147541882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.4|TWO_SIDED|95.0|0.92|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.23|0.92|0.400
73997242|NCT01732822|147541883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.482|TWO_SIDED|95.0|0.91|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.23|0.91|0.482
73997243|NCT01732822|147541884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.913|TWO_SIDED|95.0|0.89|1.11||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.11|0.89|0.913
73997244|NCT01732822|147541885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.724|TWO_SIDED|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.13|0.92|0.724
73997245|NCT01732822|147541886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.846|TWO_SIDED|95.0|0.79|1.33||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.33|0.79|0.846
73997246|NCT01732822|147541887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.298|TWO_SIDED|95.0|0.87|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.05|0.87|0.298
73997247|NCT01732822|147541888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.462|TWO_SIDED|95.0|0.9|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.05|0.90|0.462
73997248|NCT01732822|147541889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.793|TWO_SIDED|95.0|0.92|1.12|||Regression, Cox|||||1.12|0.92|0.793
73997249|NCT01732822|147541890|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.92|1.09|||Regression, Cox|||||1.09|0.92|1.000
73997250|NCT01732822|147541891|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.829|TWO_SIDED|95.0|0.91|1.08|||Regression, Cox|||||1.08|0.91|0.829
73997251|NCT01732822|147541892|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.949|TWO_SIDED|95.0|0.92|1.08|||Regression, Cox|||||1.08|0.92|0.949
73997252|NCT01732822|147541893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.377|TWO_SIDED|95.0|0.78|1.1|||Regression, Cox|||||1.10|0.78|0.377
73997253|NCT01732822|147541897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.164|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox|||||1.06|0.71|0.164
73997254|NCT01732822|147541898|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.306|TWO_SIDED|95.0|0.67|1.14|||Regression, Cox|||||1.14|0.67|0.306
73997255|NCT01732822|147541899|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.887|TWO_SIDED|95.0|0.93|1.09|||Regression, Cox|||||1.09|0.93|0.887
73997256|NCT01732822|147541900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.489|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|||||1.43|0.84|0.489
73997257|NCT01732822|147541901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.138|TWO_SIDED|95.0|0.95|1.43|||Regression, Cox|||||1.43|0.95|0.138
73997258|NCT01732822|147541902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.139|TWO_SIDED|95.0|0.95|1.41|||Regression, Cox|||||1.41|0.95|0.139
74090397|NCT02696031|147734214|SUPERIORITY||LS Mean of Treatment Difference|2.64|STANDARD_ERROR_OF_MEAN|0.803||0.0011|TWO_SIDED|95.0|1.06|4.22||unadjusted p-value|ANCOVA|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|4.22|1.06|0.0011
73997259|NCT01732822|147541903|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58|||<|0.001|TWO_SIDED|95.0|1.24|2.0|||Regression, Cox|||||2.00|1.24|<0.001
73997260|NCT02314780|147541904|OTHER||||||=|0.001|||||||ANOVA|||||||=0.001
73997261|NCT02314780|147541905|OTHER||||||=|0.002|||||||ANOVA|||||||=0.002
73997262|NCT02314780|147541906|OTHER||||||=|0.002|||||||ANOVA|||||||=0.002
73997263|NCT02314780|147541907|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73997264|NCT02314780|147541908|OTHER||||||=|0.138|||||||ANOVA|||||||=0.138
73997265|NCT02314780|147541909|OTHER||||||=|0.696|||||||ANOVA|||||||=0.696
73997266|NCT00215137|147541920|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||A Wilcoxon Signed Rank test was performed on the difference between the open label endpoint and baseline YBOCS scores.||||0.0002
73997267|NCT00215137|147541920|SUPERIORITY_OR_OTHER|||||||0.0417|TWO_SIDED|95.0|||||Wilcoxon Rank Sum Test|||A Wilcoxon Rank Sum Test was performed on the difference in the pre and post randomization YBOCS scores, using grouping to either escitalopram or placebo as a grouping variable.||||.0417
73997268|NCT00926497|147541937|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||The trial was designed to obtain a power of 90% to detect a 30% difference between the two groups in the duration of antibiotic therapy with an estimated standard deviation of 50%.||||0.002
73997269|NCT00926497|147541938|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|||||||0.012
73997270|NCT00926497|147541938|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
73997271|NCT03151993|147541970|NON_INFERIORITY|The non-inferiority hypothesis would be declared if the lower limit of the 95% CI for an mRS score of 0-1 on day 90 did not cross the margin of noninferiority of 16%. The non-inferiority hypothesis was tested using Welch's t-test for the primary outcome only.|Odds Ratio (OR)|9.5|||<|0.01|TWO_SIDED|95.0|-1.7|20.7|||Welch's t-test|||||20.7|-1.7|<0.01
73997272|NCT03547739|147541988|SUPERIORITY||Risk Ratio (RR)|4.22|||<|0.001|TWO_SIDED|95.0|2.88|6.18|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and couple age disparity.|Home visits as compared to Standard Care||6.18|2.88|<0.001
73997273|NCT03547739|147541988|SUPERIORITY||Risk Ratio (RR)|3.69|||<|0.001|TWO_SIDED|95.0|2.5|5.45|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and couple age disparity.|HIV Self-testing as compared to Standard Care||5.45|2.50|<0.001
73997274|NCT03547739|147541989|SUPERIORITY||Risk Ratio (RR)|1.21||||0.001|TWO_SIDED|95.0|1.12|1.31|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and and couple age disparity.|Comparison of the Home Visit arm with Standard Care||1.31|1.12|.001
73997275|NCT03547739|147541989|SUPERIORITY||Risk Ratio (RR)|1.26||||0.001|TWO_SIDED|95.0|1.17|1.36|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and and couple age disparity.|Comparison of HIVST arm with Standard Care arm||1.36|1.17|.001
73997276|NCT03547739|147542003|SUPERIORITY||Risk Ratio (RR)|1.08||||0.011|TWO_SIDED|95.0|1.03|1.12|||Chi-squared||Generalized Estimating Equation model (binomial family and log link) with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth, length of couple relationship, and couple age disparity.|Comparison of the Home Visit arm with Standard Care||1.12|1.03|.011
73997277|NCT03547739|147542003|SUPERIORITY||Risk Ratio (RR)|1.02||||0.011|TWO_SIDED|95.0|0.97|1.08|||Chi-squared||Generalized Estimating Equation model (binomial family and log link) with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth, length of couple relationship, and couple age disparity.|Comparison of the HIVST arm with Standard Care||1.08|0.97|0.011
73997278|NCT03547739|147542004|OTHER||Kaplan Meier estimates|0.92||||0.087|TWO_SIDED|95.0|0.86|0.95|||Log Rank|||||0.95|0.86|0.087
73997279|NCT03547739|147542004|OTHER||Kaplan Meier estimates|0.96||||0.087|TWO_SIDED|95.0|0.91|0.98|||Log Rank|||||0.98|0.91|0.087
73997280|NCT03547739|147542004|OTHER||Kaplan Meier estimates|0.98||||0.087|TWO_SIDED|95.0|0.93|0.99|||Log Rank|||||0.99|0.93|0.087
73997281|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|7.11|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997282|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 50 lux is reported."|Slope|5.98|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997283|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 50 lux is reported."|Slope|7.17||||0.0006|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0006
73997284|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 50 lux is reported."|Slope|4.75|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73876872|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-2.6||||0.833|TWO_SIDED|95.0|-26.4|21.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||21.3|-26.4|0.833
73997285|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|5.95||||0.0002|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0002
73997286|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D2m at 500 lux is reported."|Slope|6.92||||0.0285|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0285
73997287|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 500 lux is reported."|Slope|6.99|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997288|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|6.8|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73876873|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-4.6||||0.732|TWO_SIDED|95.0|-30.9|21.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||21.7|-30.9|0.732
73997289|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 500 lux is reported."|Slope|5.94||||0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0001
73997290|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 500 lux is reported."|Slope|5.85||||0.012|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.012
74090398|NCT02696031|147734215|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|ANCOVA|||week 16|"LS Mean, 95% CI, and p-value were from an ANCOVA model with treatment group and stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates.~Missing data were imputed using multiple imputation (MI, MAR assumption) prior to running ANCOVA."|||<0.0001
74090399|NCT02696031|147734215|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|ANCOVA|||week 16|"LS Mean, 95% CI, and p-value were from an ANCOVA model with treatment group and stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates.~Missing data were imputed using multiple imputation (MI, MAR assumption) prior to running ANCOVA."|||<0.0001
74090400|NCT02696031|147734216|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
73997291|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NYmass at 500 lux is reported."|Slope|-9.62||||0.0174|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0174
73997292|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D1m at 500 lux is reported."|Slope|-9.15||||0.013|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.013
73997293|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 50 lux is reported."|Slope|-4.06|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997294|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|0.99||||0.0068|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0068
73997295|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|1.12||||0.0485|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0485
73997296|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 50 lux is reported."|Slope|2.08||||0.0031|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0031
73997297|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|1.18||||0.0036|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0036
74090401|NCT02696031|147734216|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
73997298|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|1.05||||0.0089|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0089
73997299|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 500 lux is reported."|Slope|-4.04|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997300|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 500 lux is reported."|Slope|1.62||||0.0239|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0239
73997301|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|0.93||||0.0435|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0435
73997302|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 500 lux is reported."|Slope|1.26||||0.0126|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0126
73997303|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 50 lux is reported."|Slope|-0.73||||0.0294|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0294
73997304|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D1m at 50 lux is reported."|Slope|0.96||||0.0204|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0204
73997305|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D2m at 50 lux is reported."|Slope|1.41||||0.0004|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0004
73997306|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|-0.95||||0.0013|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0013
73997307|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|-0.77||||0.0003|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0003
73997308|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|-0.94|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997309|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Redness at 50 lux is reported."|Slope|0.81|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997310|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 500 lux is reported."|Slope|-0.87||||0.0096|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0096
73997311|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Redness at 500 lux is reported."|Slope|0.36||||0.0003|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0003
73997312|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM10 at 50 lux is reported."|Slope|2.13||||0.0063|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0063
73997313|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 50 lux is reported."|Slope|2.3||||0.0018|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0018
73997314|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Pa at 50 lux is reported."|Slope|3.22||||0.0134|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0134
73997315|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|-1.48|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997316|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|-2.48|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997317|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 50 lux is reported."|Slope|-1.264|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997318|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 50 lux is reported."|Slope|-1.47|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997319|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|-1.64|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997320|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|-1.63|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997321|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for PESC at 50 lux is reported."|Slope|1.43||||0.0313|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0313
73997322|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM5 at 500 lux is reported."|Slope|1.92||||0.0481|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0481
74008559|NCT01086410|147566982|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.34|||||TWO_SIDED|95.0|0.28|0.41|||||Analysis performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|||0.41|0.28|
74091717|NCT05472662|147737051|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|1.86||||0.113|TWO_SIDED|95.0|-0.48|4.2|||ANCOVA|||"Statistical analysis performed on the data at 15 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||4.20|-0.48|0.113
74008560|NCT04196803|147567004|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||<0.05
74008561|NCT04196803|147567005|SUPERIORITY||||||>|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||>0.05
74008562|NCT04196803|147567006|SUPERIORITY||||||>|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||>0.05
74008563|NCT04196803|147567007|SUPERIORITY||||||=|0.08|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||=0.08
74008564|NCT05097716|147567027|EQUIVALENCE|90% CI|ratio of adjusted geometric means|103.01|||||TWO_SIDED|90.0|96.66|109.77|||||The comparison was Test vs. Reference (Ritlecitinib + Tolbutamide vs. Tolbutamide).|||109.77|96.66|
73997323|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM10 at 500 lux is reported."|Slope|2.57||||0.0171|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0171
73997324|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 500 lux is reported."|Slope|3.84||||0.0007|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0007
73997325|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for dbase at 500 lux is reported."|Slope|-2.15|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997326|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 500 lux is reported."|Slope|-2.2|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997327|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|-2.44|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997328|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 500 lux is reported."|Slope|-3.01|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997329|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 500 lux is reported."|Slope|-1.82|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
73997330|NCT05731999|147542014|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 500 lux is reported."|Slope|-1.83|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
74008565|NCT05097716|147567028|EQUIVALENCE|90% CI|ratio of adjusted geometric means|99.05|||||TWO_SIDED|90.0|92.01|106.62|||||The comparison was Test vs. Reference (Ritlecitinib + Tolbutamide vs. Tolbutamide).|||106.62|92.01|
74008566|NCT01509079|147567035|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANOVA|||||||0.38
74008567|NCT00314249|147567080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.38||||||95.0|-8.56|-4.19|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-4.19|-8.56|
74008568|NCT00314249|147567081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||||95.0|-0.69|-0.38|||ANOVA|||This parameter was analyzed using an ANOVA model with treatment group and study center as factors.||-0.38|-0.69|
74090402|NCT01901874|147734218|OTHER|"Acceptable performance: favorably exclude PG=16.9% with 95.1% confidence.~Wa = expected weight (proportion) anatomic = 35% Pa = CEA expected anatomic MAE = 11% Wc = expected weight (proportion) comorbid = 65% Pc = CEA expected comorbid MAE = 14% D = noninferiority delta = 4%~PG = 0.35 x 11% + 0.65 x 14% + 4% = 16.9%"|Weighted binomial proportion|0.0448|STANDARD_ERROR_OF_MEAN|0.0241|<|1e-05|ONE_SIDED|95.1||0.0846||A priori 1-sided alpha = 0.049 (from simulation) to ensure overall type-1 error rate ≤ 0.05.|Binomial test (normal approximation)||Weighted by expected fractions of anatomic and comorbid high risk subjects (35% and 65%, respectively). Standard error based on H0.|"Test null hypothesis of equal or greater proportion with 1-year MAE compared to a performance goal (PG).~H0: P ≥ 16.9% vs H1: P \< 16.9%, where P is the true proportion of CAS subjects with 1-year MAE and 16.9% is the PG based on outcomes reported for patients treated with carotid endarterectomy (CEA).~N=280 subjects provide ≥90% power to exclude PG with 95.1% confidence if P=10.2% under H1."||0.0846||<0.00001
74090403|NCT01901874|147734226|OTHER||Cumulative probability|0.018|||||TWO_SIDED|95.0|0.007|0.047|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)|||0.047|0.007|
74090404|NCT01901874|147734227|OTHER||Cumulative probability|0.022|||||TWO_SIDED|95.0|0.009|0.052|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)|||0.052|0.009|
74090405|NCT04632706|147734231|OTHER|||||||0.803||||||If the p-value is more than 0.05 then dose proportionality can not be confirmed.|Mixed Models Analysis|||Assessment of dose proportionality on D2 and D28||||0.803
74090406|NCT04632706|147734233|OTHER|||||||0.689||||||If the p-value is more than 0.05 then dose proportionality can not be confirmed.|Mixed Models Analysis|||Assessment of dose proportionality on D2 and D28||||0.689
74090407|NCT01843348|147734248|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|Least square mean|-9.35|||<|0.0001|TWO_SIDED|95.0|-13.82|-4.88|||ANOVA|||The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin||-4.88|-13.82|<0.0001
74090408|NCT01843348|147734248|NON_INFERIORITY_OR_EQUIVALENCE|The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin|Least squares mean|-5.56||||0.0067|TWO_SIDED|95.0|-9.56|-1.55||Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|ANOVA|||||-1.55|-9.56|0.0067
74090409|NCT01843348|147734249|SUPERIORITY_OR_OTHER||Point estimate|0.032|||||TWO_SIDED|95.0|-0.029|0.093||||||TAC+Certican - TAC+MPA - difference between groups||0.093|-0.029|
74090410|NCT01843348|147734249|SUPERIORITY_OR_OTHER||Point estimate|0.149|||||TWO_SIDED|95.0|0.076|0.221||||||CycA+Certican -Tac+MPA - difference between groups||0.221|0.076|
74090411|NCT01843348|147734253|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.028|||<|0.001|TWO_SIDED|95.0|-0.032|0.087|||Pearson's chi-square test|||BPAR - treatment differences at Month 12||0.087|-0.032|< 0.001
73997331|NCT05731999|147542016|OTHER||probability|0.000244|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The smallest odds ratio from the group false positives and false negative is reported.||||<0.05
73997332|NCT05731999|147542016|OTHER||probability|0.00586|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
73997333|NCT05731999|147542016|OTHER||probability|0.0193|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
73997334|NCT05731999|147542016|OTHER||probability|0.000488|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
73997335|NCT05731999|147542016|OTHER||probability|0.1133|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
74090412|NCT02994355|147734278|SUPERIORITY||Prevalence rate ratio|1.33|||<|0.05|TWO_SIDED|95.0|1.16|1.52|||Poisson Regression|||||1.52|1.16|<0.05
73997336|NCT05731999|147542016|OTHER||probability|0.0107|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
74090413|NCT02994355|147734279|SUPERIORITY||Prevalence rate ratio|1.27|||<|0.05|TWO_SIDED|95.0|1.15|1.3|||Poisson regression|||||1.30|1.15|<0.05
74090414|NCT02994355|147734280|SUPERIORITY||Prevalence rate ratio|3.23|||<|0.05|TWO_SIDED|95.0|2.29|4.55|||Poisson regression|||||4.55|2.29|<0.05
74090415|NCT00703508|147734291|SUPERIORITY_OR_OTHER|||||||0.0234||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.0234
74090416|NCT00703508|147734291|SUPERIORITY_OR_OTHER|||||||0.074||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.0740
74090417|NCT00703508|147734291|SUPERIORITY_OR_OTHER|||||||0.4698||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.4698
74090418|NCT00703508|147734291|SUPERIORITY_OR_OTHER|||||||0.118||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.1180
74090419|NCT00703508|147734291|SUPERIORITY_OR_OTHER|||||||0.0311||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.0311
74090420|NCT00703508|147734291|SUPERIORITY_OR_OTHER|||||||0.1586||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.1586
74090421|NCT01064323|147734302|OTHER|Paired T-test to detect if there was a change from baseline to 5 minutes into intermittent pneumatic compression (IPC)||||||0.02|||||||Paired t-test|||||||0.02
73876874|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|19.4||||0.468|TWO_SIDED|95.0|-15.4|54.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||54.2|-15.4|0.468
73997337|NCT01167452|147542120|SUPERIORITY_OR_OTHER||Slope|-0.74|STANDARD_DEVIATION|0.19||0.0004|TWO_SIDED||||||Regression, Linear|Multivariate adaptive regression spline (MARS) analysis||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed weight for each participant.||||0.0004
73997338|NCT01167452|147542120|SUPERIORITY_OR_OTHER||Slope|-0.56|STANDARD_DEVIATION|0.2|<|0.0001|TWO_SIDED||||||Regression, Linear|Multiple Adaptive Regression Spline (MARS)||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed body mass index for each participant.||||<0.0001
73997339|NCT01417104|147542181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.16|||<|0.031|TWO_SIDED|95.0|0.85|9.47|||t-test, 2 sided|||||9.47|0.85|<0.031
73997340|NCT01417104|147542182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.041|TWO_SIDED|95.0|0.44|4.36|||t-test, 2 sided|||||4.36|0.44|0.041
73997341|NCT01305408|147542184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2717|TWO_SIDED|95.0|-3.76|1.06||Statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||1.06|-3.76|0.2717
73997342|NCT03101462|147542207|OTHER|ANOVA||||||0.89|||||||t-test, 2 sided|||A/H1N1 Day 0||||0.89
73997343|NCT03101462|147542207|OTHER|||||||0.00082||||||This is the calculated p-value.|t-test, 2 sided|||A/H1N1 Day 7||||0.00082
73997344|NCT03101462|147542207|OTHER|||||||7.6e-05||||||This is the calculated p-value|t-test, 2 sided|||A/H1N1 Day 45||||0.000076
73997345|NCT03101462|147542207|OTHER|||||||0.63|||||||t-test, 2 sided|||A/H3N2 Day 0||||0.63
73997346|NCT03101462|147542207|OTHER|||||||0.0186||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 7||||0.0186
73997347|NCT03101462|147542207|OTHER|||||||0.0052||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 45||||0.0052
73997348|NCT03101462|147542207|OTHER|||||||0.25|||||||t-test, 2 sided|||Influenza B Day 0||||0.25
73997349|NCT03101462|147542207|OTHER|||||||0.061|||||||t-test, 2 sided|||Influenza B Day 7||||0.061
73997350|NCT03101462|147542207|OTHER|||||||0.0025|||||||t-test, 2 sided|||Influenza B Day 45||||0.0025
73997351|NCT03101462|147542208|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7||||0.24
73997352|NCT03101462|147542208|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45||||0.76
73997353|NCT03101462|147542208|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7||||0.06
73997354|NCT03101462|147542208|OTHER|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45||||0.56
73997355|NCT03101462|147542208|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7||||0.04
73997356|NCT03101462|147542208|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45||||0.16
73997357|NCT03101462|147542208|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7||||0.02
73997358|NCT03101462|147542208|OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45||||0.94
73997359|NCT03101462|147542208|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7||||0.002
73997360|NCT03101462|147542208|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45||||0.16
73997361|NCT03101462|147542208|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7||||0.02
73997362|NCT03101462|147542208|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45||||0.98
73997363|NCT03101462|147542209|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.04
73997364|NCT03101462|147542209|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.02
73997365|NCT03101462|147542209|OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.95
73997366|NCT03101462|147542209|OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.17
73997367|NCT03101462|147542209|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.06
73997368|NCT03101462|147542209|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.14
73997369|NCT03101462|147542209|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.02
73997370|NCT03101462|147542209|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.09
73997371|NCT03101462|147542209|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.01
73997372|NCT03101462|147542209|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.08
73997373|NCT03101462|147542209|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.16
73997374|NCT03101462|147542209|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.76
73997375|NCT03101462|147542209|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.84
73997376|NCT03101462|147542209|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.04
73997377|NCT03101462|147542209|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.07
73997378|NCT03101462|147542209|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.27
73997379|NCT03101462|147542209|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.11
73997380|NCT03101462|147542209|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.46
73997381|NCT03101462|147542209|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.006
73876875|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-11.2||||0.339|TWO_SIDED|95.0|-34.1|11.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||11.7|-34.1|0.339
73876876|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-14.5||||0.263|TWO_SIDED|95.0|-39.3|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||10.2|-39.3|0.263
73876877|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|11.9||||0.697|TWO_SIDED|95.0|-22.3|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||46.0|-22.3|0.697
73876878|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||19.9|-23.2|0.880
73876879|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||11.2|-32.7|0.355
73997382|NCT03101462|147542209|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.41
73997383|NCT03101462|147542210|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45||||0.72
73997384|NCT03101462|147542210|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and 45||||0.06
73997385|NCT03101462|147542210|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45||||0.75
74036267|NCT03150108|147624938|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-8 values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.87|1.35||||||||1.35|0.87|
74090422|NCT01064323|147734309|OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.2
73876880|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-27.1|37.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||37.1|-27.1|1.000
73997386|NCT03101462|147542210|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45||||0.05
73997387|NCT03101462|147542210|OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and Day 45||||0.0004
73876881|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|1.5||||0.891|TWO_SIDED|95.0|-19.6|22.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||22.6|-19.6|0.891
73876882|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-3.3||||0.779|TWO_SIDED|95.0|-25.8|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||19.3|-25.8|0.779
73997388|NCT03101462|147542210|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45||||0.02
73997389|NCT03101462|147542211|OTHER|||||||0.02|||||||Fisher Exact|||Fold increase IgA anti-H1N1 HA, Day 7||||0.02
73997390|NCT03101462|147542211|OTHER|||||||0.67|||||||Fisher Exact|||Fold increase IgA anti-H3N2, Day 7||||0.67
73997391|NCT03101462|147542211|OTHER|||||||0.3|||||||Fisher Exact|||Fold increase IgA anti-influenza B HA, Day 7||||0.30
73997392|NCT02770612|147542215|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||We used a one sided one sample Wilcoxon test to compare the median number of oxycodone tablets chosen and prescribed to the institutional standard of 40 tablets of oxycodone 5mg on discharge||||<0.001
73997393|NCT02369068|147542219|OTHER|||||||0.072|||||||Kruskal-Wallis|This test was selected since the distribution of the change in pain was not normal nor approximately symmetric.||The null hypothesis assumed there were no differences in the pain score change between groups. Significance level was set at 0.05.||||0.072
73997394|NCT02369068|147542220|OTHER|||||||0.624|||||||Kruskal-Wallis|||The null hypothesis assumed there were no differences in the median change pain severity between the groups. Significance level was set at 0.05||||0.624
73997395|NCT02369068|147542221|OTHER|||||||0.571|||||||Kruskal-Wallis|||The null hypothesis assumed that there is no difference in the change in pain interference between the groups. Statistical significance was set at 0.05||||0.571
73997396|NCT02369068|147542222|OTHER|||||||0.285|||||||Kruskal-Wallis|||The null hypothesis assumed that there was no difference in the distribution between the groups. Significance level was set at 0.05||||0.285
73997397|NCT00799981|147542244|OTHER|||||||0.8762|||||||Wilcoxon (Mann-Whitney)|||The hypothesis that a 10 cm catheter provides equal emptying of the bladder as a 7 cm catheter was tested.||||0.8762
74090423|NCT00653991|147734328|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
74090424|NCT03431974|147734330|SUPERIORITY|||||||0.43|||||||Fisher Exact|||The efficacy of LD-AMT established using a step-down analysis approach with one-sided Fisher's exact tests. First, the analysis for subjects attaining PASI 75 will be performed, then, if that analysis shows a significant treatment effect, analysis for subjects attaining a sPGA success will be performed.||||0.43
73876883|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||39.9|-23.7|0.678
73876884|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|4.6||||0.663|TWO_SIDED|95.0|-16.0|25.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||25.2|-16.0|0.663
73876885|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-8.8||||0.494|TWO_SIDED|95.0|-28.7|11.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||11.0|-28.7|0.494
73876886|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|21.9||||0.083|TWO_SIDED|95.0|7.6|36.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||36.2|7.6|0.083
73876887|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|15.0||||0.151|TWO_SIDED|95.0|-2.1|32.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||32.0|-2.1|0.151
73997398|NCT00799981|147542245|OTHER|||||||0.7905|||||||McNemar|||||||0.7905
73997399|NCT00799981|147542246|OTHER|||||||1|||||||McNemar|||||||1.00
73997400|NCT00799981|147542249|OTHER|||||||0.0273|||||||Wilcoxon (Mann-Whitney)|||In the table 0=No and 1=Yes.||||0.0273
73997401|NCT01669577|147542327|SUPERIORITY_OR_OTHER||GEE(Generalyzed Estimation Equation)|0.989214|||<|0.001|TWO_SIDED|95.0|0.982855|0.995613||arterial hemoglobin Oxygen saturation|ANOVA|Non parametric(NPar) ANOVA|GEE model (dichotomous response variable)with logit link function. The NPar ANOVA (p\<0.1 for death) was the test used for inclusion in the model variables for the final models - backward method, with alpha equal to 0.05.|"significance level of 0.05, power of 0.80, moderate correlation of 0.5 between time periods and assumption that the variability is equal within each factor (non-sphericity). Due to the effect size between 0.1 and 0.5, there was no need for samples larger than 140 patients. A total of 200 patients was defined conservatively, with a margin for possible deaths. The software G\*Power 3.1.7 was used for sample size calculation.~Fischer's test, Mann-Whitney, t-test; Non parametric ANOVA and GEE"||0.995613|0.982855|< 0.001
73997402|NCT01669577|147542327|SUPERIORITY_OR_OTHER||GEE|0.99728|||<|0.001|TWO_SIDED|95.0|0.995791|0.998772|||ANOVA|||diastolic arterial blood pressure||0.998772|0.995791|< 0.001
73876888|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-22.4|24.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||24.1|-22.4|1.000
73997403|NCT01669577|147542327|SUPERIORITY_OR_OTHER||GEE|1.046961|||<|0.004|TWO_SIDED|95.0|1.012521|1.082572|||ANOVA|||lactate||1.082572|1.012521|< 0.004
73997404|NCT01669577|147542327|SUPERIORITY_OR_OTHER||GEE|0.973987|||<|0.001|TWO_SIDED|95.0|0.965308|0.982744|||ANOVA|||Glasgow coma score||0.982744|0.965308|<0.001
73997405|NCT01669577|147542327|SUPERIORITY_OR_OTHER||GEE|1.000013|||<|0.023|TWO_SIDED|95.0|1.0|1.000025|||ANOVA|||amount of Infused crystalloids||1.000025|1.000000|<0.023
73876889|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|0.4||||1|TWO_SIDED|95.0|-25.4|26.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||26.3|-25.4|1.000
73997406|NCT01989169|147542381|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios were within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.215|||||TWO_SIDED|90.0|1.116|1.323|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUCinf, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.323|1.116|
74008569|NCT00314249|147567082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||||95.0|-3.27|-0.11|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-0.11|-3.27|
74008570|NCT00314249|147567083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06|||<|0.001||95.0|1.45|2.94||Closed testing procedure used to control overall type 1 error rate at 5%: fibromyalgia syndrome tested prior to fibromyalgia pain|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with treatment group, baseline pain score, and baseline SF-36 PCS score as explanatory variables.||2.94|1.45|<0.001
73876890|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-9.2||||0.417|TWO_SIDED|95.0|-31.3|12.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||12.9|-31.3|0.417
73997407|NCT01989169|147542382|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.216|||||TWO_SIDED|90.0|1.115|1.327|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUClast, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.327|1.115|
73997408|NCT01989169|147542383|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.383|||||TWO_SIDED|90.0|1.282|1.491|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in Cmax, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.491|1.282|
73997409|NCT02406677|147542384|SUPERIORITY||Hazard Ratio (HR)|1.073||||0.3503|TWO_SIDED|95.0|0.925|1.246|||Regression, Cox|Cox proportional hazards model accounting for within hospital clustering using robust standard errors|Usual Care arm is the reference group|||1.246|0.925|0.3503
73997410|NCT02406677|147542385|SUPERIORITY||Odds Ratio (OR)|0.838||||0.026|TWO_SIDED|95.0|0.717|0.979|||Regression, Logistic|Logistic regression model with parameters estimated using GEE to account for within hospital clustering for selected patient characteristics||||0.979|0.717|0.0260
73997411|NCT02406677|147542386|SUPERIORITY||Odds Ratio (OR)|2.035|||<|0.0001|TWO_SIDED|95.0|1.564|2.649|||Regression, Logistic|Logistic regression with GEE to account for within hospital clustering||||2.649|1.564|<0.0001
73997412|NCT05384938|147542479|OTHER|Single group|Median time to response|100.0|||||TWO_SIDED|95.0|65.0|160.0|||||Estimate for Time to Response using Kaplan-Meier method|Estimate for Time to Response (Days)||160.0|65.00|
73997413|NCT05384938|147542483|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 4 (Visit 2)||||<0.0001
73997414|NCT05384938|147542483|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 16 (Visit 4)||||<0.0001
73997415|NCT05384938|147542483|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 24 (Visit 5)||||<0.0001
74090425|NCT03864042|147734351|OTHER||Geometric LS Mean Ratio|1.17|||||TWO_SIDED|90.0|0.978|1.4|||||Day 1 / Day -7|||1.40|0.978|
74090426|NCT03864042|147734351|OTHER||Geometric LS Mean Ratio|0.258|||||TWO_SIDED|90.0|0.215|0.308|||||Day 14 / Day -7|||0.308|0.215|
74090427|NCT03864042|147734352|OTHER||Geometric LS Mean Ratio|1.12|||||TWO_SIDED|90.0|0.998|1.25|||||Day 1 / Day -7|||1.25|0.998|
74090428|NCT03864042|147734352|OTHER||Geometric LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.12|1.4|||||Day 14 / Day -7|||1.40|1.12|
74090429|NCT03864042|147734353|OTHER||Geometric LS Mean Ratio|1.34|||||TWO_SIDED|90.0|1.12|1.62|||||Day 1 / Day -7|||1.62|1.12|
73997416|NCT02626455|147542485|SUPERIORITY|Comparison of PFS|Hazard Ratio (HR)|1.125|||=|0.827974|TWO_SIDED|95.0|0.881|1.437||Significance level is 0.025.|Log Rank|PFS was evaluated with a one-sided stratified log- rank test. HR and 95% CI are based on the stratified Cox regression model.||||1.437|0.881|= 0.827974
73997417|NCT02626455|147542488|SUPERIORITY|ORR of Copa+R-B/R-CHOP minus ORR of Pbo+R-B/R-CHOP|Difference|-1.25|||=|0.658652|TWO_SIDED|95.0|-7.25|4.75||Significance level is 0.025. P-values are descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||4.75|-7.25|= 0.658652
73876891|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-20.2||||0.125|TWO_SIDED|95.0|-46.7|6.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||6.2|-46.7|0.125
73997418|NCT02626455|147542489|SUPERIORITY|ORR of Copa+R-B/R-CHOP minus ORR of Pbo+R-B/R-CHOP|Difference|-0.8|||=|0.605183|TWO_SIDED|95.0|-6.64|5.05||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||5.05|-6.64|=0.605183
73997419|NCT02626455|147542490|SUPERIORITY|Comparison of DOR|Hazard Ratio (HR)|1.145|||=|0.846204|TWO_SIDED|95.0|0.883|1.484||Significance level is 0.025, P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|DOR was evaluated with a one-sided stratified log-rank test. HR and its 95% CI were based on the stratified Cox regression model.||||1.484|0.883|= 0.846204
74090430|NCT03864042|147734353|OTHER||Geometric LS Mean Ratio|0.622|||||TWO_SIDED|90.0|0.517|0.748|||||Day 14 / Day -7|||0.748|0.517|
74090431|NCT03864042|147734354|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.975|1.23|||||Day 1 / Day -7|||1.23|0.975|
74090432|NCT03864042|147734354|OTHER||Geometric LS Mean Ratio|1.3|||||TWO_SIDED|90.0|1.16|1.46|||||Day 14 / Day -7|||1.46|1.16|
74090433|NCT03864042|147734355|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.922|1.2|||||Day 1 / Day -7|||1.20|0.922|
74090434|NCT03864042|147734355|OTHER||Geometric LS Mean Ratio|1.13|||||TWO_SIDED|90.0|0.992|1.29|||||Day 14 / Day -7|||1.29|0.992|
74090435|NCT03864042|147734356|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.99|1.19|||||Day 1 / Day -7|||1.19|0.990|
74090436|NCT03864042|147734356|OTHER||Geometric LS Mean Ratio|1.1|||||TWO_SIDED|90.0|1.0|1.22|||||Day 14 / Day -7|||1.22|1.00|
74090437|NCT03864042|147734357|OTHER||Geometric LS Mean Ratio|0.894|||||TWO_SIDED|90.0|0.741|1.08|||||Day 1 / Day -7|||1.08|0.741|
74090438|NCT03864042|147734357|OTHER||Geometric LS Mean Ratio|0.692|||||TWO_SIDED|90.0|0.573|0.835|||||Day 14 / Day -7|||0.835|0.573|
74090439|NCT03864042|147734358|OTHER||Geometric LS Mean Ratio|1.32|||||TWO_SIDED|90.0|0.861|2.04|||||Day 1 / Day -7|||2.04|0.861|
74090440|NCT03864042|147734358|OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.659|1.56|||||Day 14 / Day -7|||1.56|0.659|
73997420|NCT02626455|147542491|SUPERIORITY|Comparison of DOR|Hazard Ratio (HR)|1.117|||=|0.801735|TWO_SIDED|95.0|0.865|1.443||Significance level is 0.025, P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|DOR was evaluated with a one-sided stratified log-rank test. HR and its 95% CI were based on the stratified Cox regression model.||||1.443|0.865|= 0.801735
73997421|NCT02626455|147542492|SUPERIORITY|CRR of Copa+R-B/R-CHOP minus CRR of Pbo+R-B/R-CHOP|Difference|-2.74|||=|0.741153|TWO_SIDED|95.0|-11.06|5.57||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||5.57|-11.06|= 0.741153
73997422|NCT02626455|147542493|SUPERIORITY|CRR of Copa+R-B/R-CHOP minus CRR of Pbo+R-B/R-CHOP|Difference|-2.21|||=|0.696482|TWO_SIDED|95.0|-10.62|6.2||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||6.20|-10.62|= 0.696482
73997423|NCT02626455|147542494|SUPERIORITY|DCR of Copa+R-B/R-CHOP minus DCR of Pbo+R-B/R-CHOP|Difference|-3.95|||=|0.936009|TWO_SIDED|95.0|-9.04|1.14||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference||||1.14|-9.04|= 0.936009
73997424|NCT02626455|147542495|SUPERIORITY|DCR of Copa+R-B/R-CHOP minus DCR of Pbo+R-B/R-CHOP|Difference|-3.89|||=|0.944242|TWO_SIDED|95.0|-8.68|0.9||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference||||0.90|-8.68|= 0.944242
73997425|NCT02626455|147542496|SUPERIORITY|Comparison of TTP|Hazard Ratio (HR)|1.006|||=|0.517849|TWO_SIDED|95.0|0.777|1.303||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTP was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.303|0.777|= 0.517849
73997426|NCT02626455|147542497|SUPERIORITY|Comparison of TTP|Hazard Ratio (HR)|0.971|||=|0.411398|TWO_SIDED|95.0|0.75|1.257||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTP was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.257|0.750|= 0.411398
73997427|NCT02626455|147542498|SUPERIORITY|Comparison of TTNT|Hazard Ratio (HR)|1.289|||=|0.955865|TWO_SIDED|95.0|0.962|1.728||Significance level IS 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTNT was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.728|0.962|= 0.955865
73997428|NCT02626455|147542499|SUPERIORITY|Comparison of OS|Hazard Ratio (HR)|1.132|||=|0.758563|TWO_SIDED|95.0|0.8|1.603||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|OS was evaluated with a one-sided stratified log-rank test. HR and 95% CI are based on the stratified Cox regression model.||||1.603|0.800|= 0.758563
73997429|NCT02626455|147542500|SUPERIORITY|Comparison of time to deterioration in DRS-P|Hazard Ratio (HR)|1.394|||=|0.999695|TWO_SIDED|95.0|1.149|1.691||Significance level IS 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|Time to deterioration in DRS-P was evaluated with one-sided stratified log-rank test.HR and its 95% CI are based on stratified Cox regression model.||||1.691|1.149|= 0.999695
74036268|NCT03150108|147624938|OTHER|Dose proportionality|Increase in AUC0-8 per Dose Doubling|2.23|||||TWO_SIDED|90.0|1.98|2.51|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUC0-8 using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.51|1.98|
73997430|NCT02626455|147542501|SUPERIORITY|Comparison of time to improvement in DRS-P|Hazard Ratio (HR)|0.81|||=|0.965639|TWO_SIDED|95.0|0.642|1.02||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|Time to improvement in DRS-P was evaluated with one-sided stratified log-rank test.HR and its 95% CI are based on the stratified Cox regression model.||||1.020|0.642|= 0.965639
73997431|NCT00128102|147542537|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.858|TWO_SIDED|95.0|0.83|1.17|||Log Rank|||||1.17|0.83|0.858
73997432|NCT00128102|147542541|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.63|0.88|||Likelihood Based Score Test|||||0.88|0.63|<0.001
73997433|NCT00128102|147542542|SUPERIORITY||Difference in Percentage|0.3||||0.621|TWO_SIDED|95.0|-1.18|1.97|||Fisher Exact|||||1.97|-1.18|0.621
73997434|NCT00128102|147542543|SUPERIORITY||Difference in Percent Change|-52.4||||0.259|TWO_SIDED|95.0|-143.5|38.6|||Longitudinal Model|||||38.6|-143.5|0.259
73997435|NCT00128102|147542544|SUPERIORITY||Difference in Percentage|-1.3||||0.736|TWO_SIDED|95.0|-7.2|4.53|||Fisher Exact|||||4.53|-7.20|0.736
73997436|NCT00128102|147542545|SUPERIORITY||Difference in Percent Change|-0.06||||0.979|TWO_SIDED|95.0|-4.61|4.49|||Longitudinal Model|||||4.49|-4.61|0.979
73997437|NCT00128102|147542546|SUPERIORITY||Difference in Percentage|3.1||||0.488|TWO_SIDED|95.0|-4.97|11.17|||Fisher Exact|||||11.17|-4.97|0.488
73997438|NCT04143945|147542635|OTHER|Comparison|Estimated treatment difference|2.6||||0.0395|TWO_SIDED|95.0|0.1|5.1|||ANOVA|||The intensity of pain was analysed by a fixed analysis of variance model with VAS pain score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||5.1|0.1|0.0395
73997439|NCT00833833|147542653|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.73|||||TWO_SIDED|95.0|0.54|0.99||||||With a 12-month accrual period and 12-month follow-up after the study closed to accrual, assuming a 10% drop out rate, 96 participants in each treatment arm would have had 85% power to detect a hazard rate ratio of 1.67 using a one-sided log rank test with an overall significance level of 0.025 adjusted for one interim analysis) and a significance level of 0.0245 for the final analysis.||0.99|0.54|
73997440|NCT00833833|147542658|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|6.25|||||TWO_SIDED|95.0|0.84|46.66||||||||46.66|0.84|
73997441|NCT00833833|147542659|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.070
73997442|NCT00833833|147542660|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.85|||||TWO_SIDED|95.0|0.57|1.29||||||||1.29|0.57|
74090441|NCT03864042|147734359|OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.762|1.33|||||Day 1 / Day -7|||1.33|0.762|
73997443|NCT00574873|147542694|SUPERIORITY_OR_OTHER|||||||0.667||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel|||||||0.667
73997444|NCT00574873|147542695|SUPERIORITY_OR_OTHER|||||||0.002||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel|||||||0.002
73997445|NCT00574873|147542696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.31|1.31|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||1.31|0.31|
74090442|NCT03864042|147734359|OTHER||Geometric LS Mean Ratio|0.718|||||TWO_SIDED|90.0|0.543|0.948|||||Day 14 / Day -7|||0.948|0.543|
74090443|NCT03864042|147734360|OTHER||Geometric LS Mean Ratio|4.34|||||TWO_SIDED|90.0|2.94|6.4|||||Day 1 / Day -7|||6.40|2.94|
73997446|NCT00574873|147542697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.32|1.08|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||1.08|0.32|
73997447|NCT00574873|147542698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.25|||||TWO_SIDED|95.0|0.9|11.72|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||11.72|0.90|
73997448|NCT00574873|147542699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.13|1.29|||||The hazard ratio (95% confidence interval) is obtained from a Cox model for cause-specific hazard as a function of the covariate treatment (bosutinib compared with imatinib) with stratification by region and Sokal risk group at randomization.|||1.29|0.13|
73997449|NCT03568318|147542723|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|43.8|57.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.4|43.8|<0.001
73997450|NCT03568318|147542723|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|30.8|45.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.4|30.8|<0.001
73997451|NCT03568318|147542724|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.6|||<|0.001|TWO_SIDED|95.0|41.1|54.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||54.0|41.1|<0.001
73997452|NCT03568318|147542724|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|28.5|||<|0.001|TWO_SIDED|95.0|22.1|34.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||34.9|22.1|<0.001
73997453|NCT03568318|147542725|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.8|||<|0.001|TWO_SIDED|95.0|41.9|55.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||55.7|41.9|<0.001
73997454|NCT03568318|147542725|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|36.8|||<|0.001|TWO_SIDED|95.0|29.7|43.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.8|29.7|<0.001
74008571|NCT00314249|147567084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86|||<|0.001||95.0|1.38|2.51||Closed testing procedure was used to control overall type 1 error rate at 5%: fibromyalgia pain tested after statistically significant fibromyalgia syndrome test|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with the treatment group and baseline pain score as explanatory variables.||2.51|1.38|<0.001
74090444|NCT03864042|147734360|OTHER||Geometric LS Mean Ratio|2.68|||||TWO_SIDED|90.0|1.82|3.96|||||Day 14 / Day -7|||3.96|1.82|
74090445|NCT03864042|147734361|OTHER||Geometric LS Mean Ratio|0.754|||||TWO_SIDED|90.0|0.595|0.954|||||Day 1 / Day -7|||0.954|0.595|
74090446|NCT03864042|147734361|OTHER||Geometric LS Mean Ratio|0.755|||||TWO_SIDED|90.0|0.596|0.957|||||Day 14 / Day -7|||0.957|0.596|
74090447|NCT03864042|147734362|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.864|1.27|||||Day 1 / Day -7|||1.27|0.864|
74090448|NCT03864042|147734362|OTHER||Geometric LS Mean Ratio|1.42|||||TWO_SIDED|90.0|1.17|1.72|||||Day 14 / Day -7|||1.72|1.17|
74090449|NCT03864042|147734363|OTHER||Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.92|1.25|||||Day 1 / Day -7|||1.25|0.920|
73876892|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|12.9||||0.497|TWO_SIDED|95.0|-14.1|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||40.0|-14.1|0.497
73997455|NCT03568318|147542726|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|49.9|||<|0.001|TWO_SIDED|95.0|43.3|56.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.4|43.3|<0.001
73997456|NCT03568318|147542726|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|29.5|||<|0.001|TWO_SIDED|95.0|22.8|36.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||36.3|22.8|<0.001
73997457|NCT03568318|147542727|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|43.8|57.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.3|43.8|<0.001
73997458|NCT03568318|147542727|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.4|||<|0.001|TWO_SIDED|95.0|30.4|44.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.3|30.4|<0.001
74090450|NCT03864042|147734363|OTHER||Geometric LS Mean Ratio|0.175|||||TWO_SIDED|90.0|0.151|0.204|||||Day 14 / Day -7|||0.204|0.151|
73997459|NCT03568318|147542728|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.6|||<|0.001|TWO_SIDED|95.0|51.2|63.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||63.9|51.2|<0.001
73997460|NCT03568318|147542728|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|43.8|||<|0.001|TWO_SIDED|95.0|37.0|50.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.5|37.0|<0.001
73997461|NCT03568318|147542729|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.2|||<|0.001|TWO_SIDED|95.0|31.0|43.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.3|31.0|<0.001
73997462|NCT03568318|147542729|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|24.0|||<|0.001|TWO_SIDED|95.0|18.1|29.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||29.9|18.1|<0.001
73997463|NCT03568318|147542730|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.8|||<|0.001|TWO_SIDED|95.0|32.8|44.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.8|32.8|<0.001
74008572|NCT00314249|147567085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||||95.0|0.86|2.44|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||2.44|0.86|
73876893|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-0.1||||0.993|TWO_SIDED|95.0|-24.0|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-24.0|0.993
74008573|NCT00962390|147567117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.4678|TWO_SIDED|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.1|-0.5|0.4678
73876894|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-18.3||||0.2|TWO_SIDED|95.0|-46.1|9.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||9.6|-46.1|0.200
73876895|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|21.4||||0.177|TWO_SIDED|95.0|-7.9|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||50.8|-7.9|0.177
73876896|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|22.4||||0.074|TWO_SIDED|95.0|-1.4|46.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.2|-1.4|0.074
73876897|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||20.3|-36.1|0.585
73997464|NCT03568318|147542730|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|23.3|||<|0.001|TWO_SIDED|95.0|17.7|28.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||28.9|17.7|<0.001
73997465|NCT03568318|147542731|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|16.3|26.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||26.1|16.3|<0.001
73997466|NCT03568318|147542732|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|16.2|||<|0.001|TWO_SIDED|95.0|11.3|21.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||21.1|11.3|<0.001
73997467|NCT03568318|147542732|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|9.2|||<|0.001|TWO_SIDED|95.0|4.9|13.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||13.4|4.9|<0.001
73997468|NCT03568318|147542733|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-41.79|STANDARD_ERROR_OF_MEAN|4.417|<|0.001|TWO_SIDED|95.0|-50.46|-33.11|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.11|-50.46|<0.001
74008574|NCT00962390|147567117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.4892|TWO_SIDED|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.1|-0.5|0.4892
73876898|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|21.4||||0.177|TWO_SIDED|95.0|-7.9|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||50.8|-7.9|0.177
73876899|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|12.1||||0.343|TWO_SIDED|95.0|-12.7|36.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||36.8|-12.7|0.343
74008575|NCT00962390|147567117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.8185|TWO_SIDED|95.0|-0.8|1.0||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.0|-0.8|0.8185
73876900|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||20.3|-36.1|0.585
73876901|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-30.0||||0.539|TWO_SIDED|95.0|-50.1|-9.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||-9.9|-50.1|0.539
73876902|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-15.7||||0.277|TWO_SIDED|95.0|-40.8|9.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||9.3|-40.8|0.277
73876903|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-15.7||||0.422|TWO_SIDED|95.0|-42.9|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||11.5|-42.9|0.422
73876904|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-46.5|46.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||46.5|-46.5|1.000
73876905|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-10.7||||0.454|TWO_SIDED|95.0|-34.9|13.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||13.5|-34.9|0.454
73876906|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-17.9||||0.364|TWO_SIDED|95.0|-41.1|5.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||5.4|-41.1|0.364
73997469|NCT03568318|147542733|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|LS Mean Difference|-33.08|STANDARD_ERROR_OF_MEAN|4.403|<|0.001|TWO_SIDED|95.0|-41.72|-24.44|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-24.44|-41.72|<0.001
73997470|NCT03568318|147542734|SUPERIORITY||LS Mean Difference|-41.45|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|-46.68|-36.22|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.||-36.22|-46.68|<0.001
73997471|NCT03568318|147542734|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-32.13|STANDARD_ERROR_OF_MEAN|2.659|<|0.001|TWO_SIDED|95.0|-37.35|-26.91|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-26.91|-37.35|<0.001
73876907|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||55.2|-35.2|0.544
73997472|NCT03568318|147542735|SUPERIORITY||Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|38.8|67.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.4|38.8|<0.001
73997473|NCT03568318|147542735|SUPERIORITY||Adjusted Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|16.3|49.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||49.0|16.3|<0.001
73876908|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||14.6|-25.5|0.663
73997474|NCT03568318|147542736|SUPERIORITY||Adjusted Response Rate Difference|55.4|||<|0.001|TWO_SIDED|95.0|41.4|69.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.5|41.4|<0.001
73997475|NCT03568318|147542736|SUPERIORITY||Adjusted Response Rate Difference|26.3|||<|0.001|TWO_SIDED|95.0|12.1|40.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.4|12.1|<0.001
73997476|NCT03568318|147542737|SUPERIORITY||Adjusted Response Rate Difference|30.5|||<|0.001|TWO_SIDED|95.0|14.1|46.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||46.8|14.1|<0.001
73997477|NCT03568318|147542737|SUPERIORITY||Adjusted Response Rate Difference|24.5||||0.003|TWO_SIDED|95.0|8.2|40.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.8|8.2|0.003
73997478|NCT03568318|147542738|SUPERIORITY||Adjusted Response Rate Difference|52.0|||<|0.001|TWO_SIDED|95.0|37.3|66.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.7|37.3|<0.001
73997479|NCT03568318|147542738|SUPERIORITY||Adjusted Response Rate Difference|27.1||||0.001|TWO_SIDED|95.0|11.1|43.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.1|11.1|0.001
73997480|NCT03568318|147542739|SUPERIORITY||Adjusted Response Rate Difference|23.5||||0.006|TWO_SIDED|95.0|6.9|40.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.1|6.9|0.006
73997481|NCT03568318|147542739|SUPERIORITY||Adjusted Response Rate Difference|22.7||||0.007|TWO_SIDED|95.0|6.2|39.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||39.2|6.2|0.007
73997482|NCT03568318|147542740|SUPERIORITY||Adjusted Response Rate Difference|49.3|||<|0.001|TWO_SIDED|95.0|34.1|64.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||64.6|34.1|<0.001
73997483|NCT03568318|147542740|SUPERIORITY||Adjusted Response Rate Difference|26.2||||0.002|TWO_SIDED|95.0|9.4|43.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.1|9.4|0.002
73997484|NCT03568318|147542741|SUPERIORITY||Adjusted Response Rate Difference|41.5|||<|0.001|TWO_SIDED|95.0|27.8|55.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||55.1|27.8|<0.001
73997485|NCT03568318|147542741|SUPERIORITY||Adjusted Response Rate Difference|24.4||||0.001|TWO_SIDED|95.0|10.3|38.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||38.4|10.3|0.001
73997486|NCT03568318|147542742|SUPERIORITY||Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|20.6|49.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||49.3|20.6|<0.001
73997487|NCT03568318|147542742|SUPERIORITY||Adjusted Response Rate Difference|24.5||||0.001|TWO_SIDED|95.0|10.4|38.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||38.7|10.4|0.001
73997488|NCT03568318|147542743|SUPERIORITY||Adjusted Response Rate Difference|19.8||||0.001|TWO_SIDED|95.0|7.8|31.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||31.8|7.8|0.001
73997489|NCT03568318|147542744|SUPERIORITY||Adjusted Response Rate Difference|6.2||||0.306|TWO_SIDED|95.0|-5.7|18.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||18.2|-5.7|0.306
73997490|NCT03568318|147542744|SUPERIORITY||Adjusted Response Rate Difference|-1.0||||0.855|TWO_SIDED|95.0|-11.2|9.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||9.3|-11.2|0.855
73997491|NCT03568318|147542745|SUPERIORITY||LS Mean Difference|-16.05|STANDARD_ERROR_OF_MEAN|11.956||0.18|TWO_SIDED|95.0|-39.59|7.48|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||7.48|-39.59|0.180
73997492|NCT03568318|147542745|SUPERIORITY||LS Mean Difference|-26.38|STANDARD_ERROR_OF_MEAN|11.986||0.029|TWO_SIDED|95.0|-49.97|-2.79|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-2.79|-49.97|0.029
73997493|NCT03568318|147542746|SUPERIORITY||LS Mean Difference|-35.69|STANDARD_ERROR_OF_MEAN|5.354|<|0.001|TWO_SIDED|95.0|-46.28|-25.11|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-25.11|-46.28|<0.001
73997494|NCT03568318|147542746|SUPERIORITY||LS Mean Difference|-24.37|STANDARD_ERROR_OF_MEAN|5.423|<|0.001|TWO_SIDED|95.0|-35.1|-13.65|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-13.65|-35.10|<0.001
73997495|NCT01638429|147542749|SUPERIORITY_OR_OTHER|||||||0.16|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.16
73997496|NCT01638429|147542751|SUPERIORITY_OR_OTHER|||||||0.028|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment||||0.028
73997497|NCT01638429|147542752|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment||||0.01
73997498|NCT01638429|147542753|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.97
73997499|NCT01638429|147542753|SUPERIORITY_OR_OTHER|||||||0.85|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.85
73997500|NCT01638429|147542754|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.61
73997501|NCT01638429|147542754|SUPERIORITY_OR_OTHER|||||||0.45|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.45
74090451|NCT03864042|147734364|OTHER||Geometric LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.18|1.38|||||Day 1 / Day -7|||1.38|1.18|
73997502|NCT01638429|147542755|SUPERIORITY_OR_OTHER|||||||0.018|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.018
73997503|NCT01638429|147542755|SUPERIORITY_OR_OTHER|||||||0.14|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.14
73997504|NCT01638429|147542756|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.43
73997505|NCT01638429|147542756|SUPERIORITY_OR_OTHER|||||||0.44|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.44
73997506|NCT01638429|147542757|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.13
73997507|NCT01638429|147542757|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.25
73997508|NCT01638429|147542758|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.29
73997509|NCT01638429|147542758|SUPERIORITY_OR_OTHER|||||||0.27|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.27
73997510|NCT01638429|147542759|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.22
73997511|NCT01638429|147542759|SUPERIORITY_OR_OTHER|||||||0.059|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.059
73997512|NCT01638429|147542760|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.33
73997513|NCT01638429|147542760|SUPERIORITY_OR_OTHER|||||||0.075|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.075
73997514|NCT02040584|147542767|SUPERIORITY_OR_OTHER|||||||0.9423|||||||Fisher Exact|Week 52||"Null hypothesis (H0): there were no differences in kidney function between the two groups, in contrast with the alternative hypothesis (H1), in which there were differences:~HO: CBS = CBC versus H1: CBS ≠ CBC, where CBS and CBC were percentages of patients who showed clinical benefit at Week 52 for the study group and control group, respectively."||||0.9423
73997515|NCT00734591|147542823|SUPERIORITY_OR_OTHER||Exact method|2.81|||||TWO_SIDED|95.0|0.5|28.46|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||28.46|0.50|
73997516|NCT00734591|147542824|SUPERIORITY_OR_OTHER||Exact method|2.29|||||TWO_SIDED|95.0|0.37|24.01|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||24.01|0.37|
73997517|NCT00734591|147542825|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.6|1.1||||||||1.10|0.60|
73997518|NCT00734591|147542826|SUPERIORITY_OR_OTHER||Exact method|3.75|||||TWO_SIDED|95.0|1.01|20.68|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||20.68|1.01|
73997519|NCT02236988|147542828|OTHER||Ratio of Adjusted Geometric Means|65.3|||||TWO_SIDED|90.0|55.0|77.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an analysis of variance (ANOVA) was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||77.6|55.0|
73997520|NCT02236988|147542828|OTHER||Ratio of Adjusted Geometric Means|80.4|||||TWO_SIDED|90.0|67.8|95.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||95.5|67.8|
73997521|NCT02236988|147542828|OTHER||Ratio of Adjusted Geometric Means|84.2|||||TWO_SIDED|90.0|70.9|99.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||99.9|70.9|
73997522|NCT02236988|147542830|OTHER||Ratio of Adjusted Geometric Means|61.8|||||TWO_SIDED|90.0|51.7|73.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||73.9|51.7|
73997523|NCT02236988|147542830|OTHER||Ratio of Adjusted Geometric Means|71.2|||||TWO_SIDED|90.0|59.6|85.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.1|59.6|
73997524|NCT02236988|147542830|OTHER||Ratio of Adjusted Geometric Means|73.8|||||TWO_SIDED|90.0|61.7|88.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.2|61.7|
73997525|NCT02236988|147542831|OTHER||Ratio of Adjusted Geometric Means|62.3|||||TWO_SIDED|90.0|52.1|74.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.4|52.1|
73997526|NCT02236988|147542831|OTHER||Ratio of Adjusted Geometric Means|71.3|||||TWO_SIDED|90.0|59.7|85.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.2|59.7|
73997527|NCT02236988|147542831|OTHER||Ratio of Adjusted Geometric Means|74.0|||||TWO_SIDED|90.0|62.0|88.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.4|62.0|
73997528|NCT02236988|147542832|OTHER||Median Difference|1.0||||0.009|TWO_SIDED|90.0|0.5|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 1 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.5|0.0090
73997529|NCT02236988|147542832|OTHER||Median Difference|1.26||||0.0073|TWO_SIDED|90.0|0.5|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 2 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|0.50|0.0073
73997530|NCT02236988|147542832|OTHER||Median Difference|2.0|||<|0.0001|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 3 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|<0.0001
73997531|NCT02236988|147542838|OTHER||Ratio of Adjusted Geometric Means|90.9|||||TWO_SIDED|90.0|81.8|101.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||101.1|81.8|
73997532|NCT02236988|147542838|OTHER||Ratio of Adjusted Geometric Means|73.7|||||TWO_SIDED|90.0|66.3|82.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||82.0|66.3|
73997533|NCT02236988|147542838|OTHER||Ratio of Adjusted Geometric Means|80.2|||||TWO_SIDED|90.0|72.2|89.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||89.2|72.2|
73997534|NCT02236988|147542839|OTHER||Ratio of Adjusted Geometric Means|84.9|||||TWO_SIDED|90.0|77.5|93.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||93.0|77.5|
73997535|NCT02236988|147542839|OTHER||Ratio of Adjusted Geometric Means|72.0|||||TWO_SIDED|90.0|65.8|78.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||78.9|65.8|
73997536|NCT02236988|147542839|OTHER||Ratio of Adjusted Geometric Means|78.0|||||TWO_SIDED|90.0|71.2|85.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.5|71.2|
73997537|NCT02236988|147542840|OTHER||Ratio of Adjusted Geometric Means|85.5|||||TWO_SIDED|90.0|78.1|93.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||93.6|78.1|
73997538|NCT02236988|147542840|OTHER||Ratio of Adjusted Geometric Means|72.6|||||TWO_SIDED|90.0|66.3|79.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||79.5|66.3|
73997539|NCT02236988|147542840|OTHER||Ratio of Adjusted Geometric Means|78.9|||||TWO_SIDED|90.0|72.0|86.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||86.4|72.0|
73997540|NCT02236988|147542841|OTHER||Median Difference|2.0||||0.0002|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 4 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|0.0002
73997541|NCT02236988|147542841|OTHER||Median Difference|1.02||||0.0049|TWO_SIDED|90.0|0.5|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 5 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.50|0.0049
74008576|NCT01621542|147567165|OTHER|None specified||||||||||||||||The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg|The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg|||
73997542|NCT02236988|147542841|OTHER||Median Difference|1.5||||0.001|TWO_SIDED|90.0|1.0|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 6 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|1.00|0.0010
73997543|NCT02236988|147542847|OTHER||Ratio of Adjusted Geometric Means|91.0|||||TWO_SIDED|90.0|80.4|103.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||103.0|80.4|
73997544|NCT02236988|147542847|OTHER||Ratio of Adjusted Geometric Means|88.4|||||TWO_SIDED|90.0|78.1|100.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||100.0|78.1|
73997545|NCT02236988|147542848|OTHER||Ratio of Adjusted Geometric Means|80.6|||||TWO_SIDED|90.0|73.8|88.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.0|73.8|
73997546|NCT02236988|147542848|OTHER||Ratio of Adjusted Geometric Means|78.5|||||TWO_SIDED|90.0|71.9|85.7|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.7|71.9|
73997547|NCT02236988|147542849|OTHER||Ratio of Adjusted Geometric Means|81.1|||||TWO_SIDED|90.0|74.3|88.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.6|74.3|
73997548|NCT02236988|147542849|OTHER||Ratio of Adjusted Geometric Means|79.0|||||TWO_SIDED|90.0|72.3|86.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||86.3|72.3|
73997549|NCT02236988|147542850|OTHER||Median Difference|0.98||||0.0374|TWO_SIDED|90.0|0.02|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 8 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.02|0.0374
73997550|NCT02236988|147542850|OTHER||Median Difference|0.51||||0.1907|TWO_SIDED|90.0|0.0|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 9 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.00|0.1907
73997551|NCT02236988|147542856|OTHER||Ratio of Adjusted Geometric Means|109.4|||||TWO_SIDED|90.0|98.6|121.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||121.3|98.6|
73997552|NCT02236988|147542856|OTHER||Ratio of Adjusted Geometric Means|107.2|||||TWO_SIDED|90.0|96.4|119.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||119.2|96.4|
73997553|NCT02236988|147542856|OTHER||Ratio of Adjusted Geometric Means|72.7|||||TWO_SIDED|90.0|65.5|80.8|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||80.8|65.5|
73997554|NCT02236988|147542856|OTHER||Ratio of Adjusted Geometric Means|103.5|||||TWO_SIDED|90.0|93.1|114.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||114.9|93.1|
74008577|NCT01368042|147567168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|STANDARD_DEVIATION|32.9||0.03|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.03
74008578|NCT01368042|147567169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_DEVIATION|57.2||0.05|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)|||||0.05
74008579|NCT01368042|147567170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8|STANDARD_DEVIATION|56.4||0.003|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)|||||0.003
74090452|NCT03864042|147734364|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.974|1.14|||||Day 14 / Day -7|||1.14|0.974|
74008580|NCT01368042|147567171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_DEVIATION|30.5|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
74008581|NCT01368042|147567172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_DEVIATION|27.2|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
73997555|NCT02236988|147542857|OTHER||Ratio of Adjusted Geometric Means|81.5|||||TWO_SIDED|90.0|75.2|88.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.3|75.2|
73997556|NCT02236988|147542857|OTHER||Ratio of Adjusted Geometric Means|82.4|||||TWO_SIDED|90.0|75.9|89.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||89.5|75.9|
73997557|NCT02236988|147542857|OTHER||Ratio of Adjusted Geometric Means|68.2|||||TWO_SIDED|90.0|62.9|74.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.0|62.9|
73997558|NCT02236988|147542857|OTHER||Ratio of Adjusted Geometric Means|77.4|||||TWO_SIDED|90.0|71.3|84.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||84.0|71.3|
73997559|NCT02236988|147542858|OTHER||Ratio of Adjusted Geometric Means|81.9|||||TWO_SIDED|90.0|75.6|88.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.6|75.6|
73997560|NCT02236988|147542858|OTHER||Ratio of Adjusted Geometric Means|83.0|||||TWO_SIDED|90.0|76.5|90.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||90.1|76.5|
73997561|NCT02236988|147542858|OTHER||Ratio of Adjusted Geometric Means|68.8|||||TWO_SIDED|90.0|63.4|74.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.5|63.4|
73997562|NCT02236988|147542858|OTHER||Ratio of Adjusted Geometric Means|77.8|||||TWO_SIDED|90.0|71.8|84.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||84.4|71.8|
73997563|NCT02236988|147542859|OTHER||Median Difference|0.98||||0.0523|TWO_SIDED|90.0|0.03|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 11 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.03|0.0523
73997564|NCT02236988|147542859|OTHER||Median Difference|0.5||||0.2598|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 12 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.00|0.00|0.2598
73997565|NCT02236988|147542859|OTHER||Median Difference|1.5||||0.0053|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 13 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|0.0053
73997566|NCT02236988|147542859|OTHER||Median Difference|0.5||||0.1093|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 14 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.00|0.00|0.1093
73997567|NCT02045875|147542905|SUPERIORITY|||||||0.046||||||Effect of interaction of time and treatment group|ANOVA|||||||0.046
73997568|NCT02045875|147542906|OTHER||correlation coefficient|-0.508|||||TWO_SIDED||||||||correlation of asthma control and adherence|||||
73997569|NCT01743989|147542915|SUPERIORITY|||||||0.383|||||||Chi-squared|||||||0.383
73997570|NCT00515723|147542938|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) as the independent variable, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).||||0.002
73997571|NCT00515723|147542938|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) and treatment group as independent variables, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).||||0.002
74008582|NCT01368042|147567173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.3|STANDARD_DEVIATION|35.3|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
73997572|NCT00515723|147542939|SUPERIORITY|||||||0.05||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) as the independent variable, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).||||0.05
73997573|NCT00515723|147542939|SUPERIORITY|||||||0.22||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) and treatment group as the independent variables, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).||||0.22
74036269|NCT03150108|147624939|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-inf values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.77|1.33||||||||1.33|0.77|
74036270|NCT03150108|147624939|OTHER|Dose proportionality|Increase in AUC0-inf per Dose Doubling|2.31|||||TWO_SIDED|90.0|1.96|2.71|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUC0-inf using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.71|1.96|
73997574|NCT03843554|147542965|SUPERIORITY|Primary hypothesis. Null hypothesis is that the proportion of patients with a successful outcome of WHO OM severity grades 0-2 at the post study evaluation will not differ between the two randomized intervention groups. The estimated proportion of successes from our pilot trial is 0.30 with SOC. The alternative hypothesis is that the proportion of patients with a successful outcome differs between the two groups from the SOC proportion of 0.30 by +/-0.265 or more.||||||0.999|||||||Fisher Exact|OM WHO grading scale (less or equal to 2) severity employed a two-sided Fisher's exact test to compare the two arms at Visit 9.||||||0.999
73997575|NCT03843554|147542966|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|174.6||0.6336|TWO_SIDED|95.0||||The above t-test p-value is for IL1a.|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t-test was used to compare the change in inflammatory markers between the two groups.||||0.6336
73997576|NCT03843554|147542966|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|52.1||0.351|TWO_SIDED|95.0||||IL1b|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.3510
73997577|NCT03843554|147542966|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-102.2|STANDARD_ERROR_OF_MEAN|252.8||0.351|TWO_SIDED|95.0||||IL2|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.3510
73997578|NCT03843554|147542966|SUPERIORITY|IL4|Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|46.0||0.8371|TWO_SIDED|95.0|||||t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.8371
73997579|NCT03843554|147542966|SUPERIORITY|IL5|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|10.7||0.2991|TWO_SIDED|95.0|||||t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.2991
73997580|NCT03843554|147542967|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-0.2293|STANDARD_ERROR_OF_MEAN|0.8555||0.2373|TWO_SIDED|95.0|-1.906|1.4475|||t-test, 2 sided|||||1.4475|-1.9060|0.2373
73997581|NCT03843554|147542968|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|0.0569|STANDARD_ERROR_OF_MEAN|0.116||0.6263|TWO_SIDED|95.0|-0.1755|0.2893||A Week 8 general linear mixed effects model (GLM) was used to compare the change in saliva flow rate from Baseline (day 0) to week 8 (day 56) between the two groups. The change was calculated by subtracting week 8 saliva flow rate from the Baseline.|ANCOVA||Estimation of the difference in least-square means for the change from Baseline to FIV in saliva flow rate.|||0.2893|-0.1755|0.6263
73997582|NCT03843554|147542969|SUPERIORITY|OMDP-STANDARD|Mean Difference (Net)|-1.94||||0.6956|TWO_SIDED|95.0|||||Regression, Linear|A Week 8 (Day 56) GLM analyzing the pain change Week 8 relative to Baseline (Day 0) was used with treatment and Baseline pain as covariates.|Difference in least-square mean change from baseline to Visit 9 in pain score.|||||0.6956
73997583|NCT03843554|147542970|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-0.188|STANDARD_ERROR_OF_MEAN|0.113||0.1153|TWO_SIDED|95.0|-0.4095|0.0334|||ANCOVA|ANCOVA via generalized linear mixed repeated measures model (GLMER)||The statistical analysis comprised an ANCOVA for a longitudinal response based on a generalized linear mixed effects repeated measures model (GLMER). The response variable is the mean change from Baseline to Visit 9 in EORTC QLQ-C30 Questions 31-48 (total).||0.0334|-0.4095|0.1153
73997584|NCT01882543|147542971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.061|TWO_SIDED|95.0|-2.1|0.0|||ANCOVA|||A sample size of 28 subjects per group had 80% power to detect a 1.5-point difference in the change from baseline pain score between AQX-1125 and placebo assuming a between-subject SD of 2.0 and a 2-sided 5% significance level. Average daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the primary efficacy end point of average daily pain score||0.0|-2.1|0.061
74090453|NCT03864042|147734365|OTHER||Geometric LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.09|1.43|||||Day 1 / Day -7|||1.43|1.09|
73997585|NCT01882543|147542972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.03|TWO_SIDED|95.0|-2.5|-0.1|||ANCOVA|||E-diary maximum daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the secondary efficacy variable of maximum daily pain score||-0.1|-2.5|0.030
73997586|NCT01882543|147542973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.008|TWO_SIDED|95.0|-2.8|-0.5|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.5|-2.8|0.008
73997587|NCT01882543|147542974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.028|TWO_SIDED|95.0|-3.0|-0.2|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.2|-3.0|0.028
73997588|NCT01882543|147542975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.011|TWO_SIDED|95.0|-9.5|-1.3|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-1.3|-9.5|0.011
73997589|NCT01882543|147542976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.007|TWO_SIDED|95.0|-8.8|-1.4||ICSI/PI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-1.4|-8.8|0.007
73997590|NCT01882543|147542976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.005|TWO_SIDED|95.0|-4.6|-0.9||ICSI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.9|-4.6|0.005
73997591|NCT01882543|147542976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.014|TWO_SIDED|95.0|-4.5|-0.5||ICPI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.5|-4.5|0.014
73997592|NCT01882543|147542977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.592|TWO_SIDED|95.0|-6.3|3.6||Mental Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||3.6|-6.3|0.592
73997593|NCT01882543|147542977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.221|TWO_SIDED|95.0|-1.6|6.7||Physical Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||6.7|-1.6|0.221
73997594|NCT01882543|147542978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.04|TWO_SIDED|95.0|-5.5|-0.1|||ANOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.1|-5.5|0.040
73997595|NCT00503139|147543011|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that mHAQ scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.||||<0.001
73997596|NCT00503139|147543012|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that VAS Fatigue scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.||||<0.001
73997597|NCT00996476|147543014|SUPERIORITY_OR_OTHER||LS means difference|-2.4|||||TWO_SIDED|95.0|-2.83|-1.97|||ANCOVA||TMC435 50 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group||-1.97|-2.83|
73997598|NCT00996476|147543014|SUPERIORITY_OR_OTHER||LS Means difference|-2.41|||||TWO_SIDED|95.0|-2.85|-1.98|||ANCOVA||TMC435 100 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group||-1.98|-2.85|
73997599|NCT00996476|147543019|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-24.6|||||TWO_SIDED|95.0|-58.3|11.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 50 mg treatment group and the PR48 control group||11.8|-58.3|
73997600|NCT00996476|147543019|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-27.5|||||TWO_SIDED|95.0|-61.1|9.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 100 mg treatment group and the PR48 control group||9.8|-61.1|
73997601|NCT00996476|147543019|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-23.3|||||TWO_SIDED|95.0|-59.9|19.4|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 50 mg treatment group and the PR48 control group||19.4|-59.9|
73997602|NCT00996476|147543019|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-32.3|||||TWO_SIDED|95.0|-66.6|8.3|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 100 mg treatment group and the PR48 control group||8.3|-66.6|
73997603|NCT05540717|147543028|SUPERIORITY||relative difference (%)|-20.25||||0.00048|TWO_SIDED|95.0|-31.0|-9.49|||Mixed Models Analysis|||Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||-9.49|-31.0|0.00048
73997604|NCT05540717|147543029|SUPERIORITY||relative difference (%)|-20.2||||0.00032|TWO_SIDED|95.0|-30.13|-10.27|||Mixed Models Analysis|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||-10.27|-30.13|0.00032
73997605|NCT05540717|147543030|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-26.54||||0.0008|TWO_SIDED|95.0|-41.15|-11.94|||Mixed Models Analysis|||Comparison of dMS of CSMS on peak GPS||-11.94|-41.15|0.00080
73997606|NCT05540717|147543030|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect.|relative difference (%)|-26.6||||0.00031|TWO_SIDED|95.0|-40.49|-12.72|||Mixed Models Analysis|||Comparison of dMS of CSMS on entire GPS||-12.72|-40.49|0.00031
73997607|NCT05540717|147543031|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-16.35||||0.00223|TWO_SIDED|95.0|-26.27|-6.44|||Mixed Models Analysis|||Comparison of dSS of CSMS on peak GPS||-6.44|-26.27|0.00223
73997608|NCT05540717|147543031|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-16.58||||0.00076|TWO_SIDED|95.0|||||Mixed Models Analysis|||Comparison of dSS of CSMS on entire GPS||||0.00076
73997609|NCT05540717|147543032|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.00032|TWO_SIDED|95.0|-0.76|-0.23|||Mixed Models Analysis|Linear mixed model using treatment group as fixed effect, Baseline total RQLQ score as covariate and pooled geographical region as random effect||Average Total RQLQ Score During Peak GPS||-0.23|-0.76|0.00032
73997610|NCT05540717|147543033|SUPERIORITY||Mean Difference (Final Values)|3.99|||<|1e-05|TWO_SIDED|95.0|3.28|4.7|||Mixed Models Analysis|||Change from baseline to Visit 7 of serum grass-specific IgG4 \[mg/L\]||4.7|3.28|<0.00001
74008583|NCT01368042|147567174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7|STANDARD_DEVIATION|34.8|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||<0.001
73997611|NCT05540717|147543034|SUPERIORITY||Odds Ratio (OR)|1.254||||0.10846|TWO_SIDED|95.0|0.951|1.652|||Regression, Logistic|The probability of a well day was calculated using a generalized estimating equation (GEE) or similar approaches as appropriate.||Probability of Well Days During Peak (truncated) GPS||1.652|0.951|0.10846
73997612|NCT01470001|147543054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.7||||0.1135|TWO_SIDED|95.0|-4.3|39.7|||Mixed Models Analysis|mixed model with repeated measurements||A planned sample size of 56 subjects per group provided 80% power to detect a difference of 0.25 between post void dribbling response rates (assumed to be 0.35 under the null hypothesis and 0.60 under the alternative hypothesis) at a one-sided 0.05 significance level.||39.7|-4.3|.1135
73997613|NCT01470001|147543055|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.3||||0.0919|TWO_SIDED|95.0|-2.3|30.8|||Regression, Logistic|logistic regression with repeated measurements||||30.8|-2.3|.0919
73997614|NCT01470001|147543056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.44|TWO_SIDED|95.0|-17.5|6.2||p value was adjusted for age.|ANCOVA||we calculated the estimated difference in change between the placebo and treatment groups.|the difference in change between the groups was measured||6.2|-17.5|0.44
73997615|NCT04032613|147543065|OTHER|Paired sample t-test||||||0.2||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.20
73997616|NCT04032613|147543066|OTHER|Paired sample t-test||||||0.05||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.05
73997617|NCT04032613|147543067|OTHER|Paired sample t-test||||||0.004||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.004
73997618|NCT04032613|147543068|OTHER|Paired sample t-test||||||0.14||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.14
73997619|NCT02071290|147543077|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
73997620|NCT02071290|147543078|SUPERIORITY|||||||0.287|||||||Mixed Models Analysis|||||||0.287
73997621|NCT02071290|147543079|SUPERIORITY|||||||0.597|||||||Mixed Models Analysis|||||||0.597
73997622|NCT02071290|147543080|SUPERIORITY|||||||0.307|||||||Mixed Models Analysis|||||||0.307
73997623|NCT02071290|147543081|SUPERIORITY|||||||0.646|||||||Mixed Models Analysis|||||||0.646
73997624|NCT02071290|147543082|SUPERIORITY|||||||0.757|||||||Mixed Models Analysis|||||||0.757
73997625|NCT02071290|147543083|SUPERIORITY|||||||0.075|||||||Mixed Models Analysis|||||||0.075
74036271|NCT03150108|147624945|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.13|||||TWO_SIDED|90.0|0.9|1.4||||||||1.40|0.90|
74036272|NCT03150108|147624947|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.25||||||||1.25|0.93|
74036273|NCT01975935|147624956|SUPERIORITY|||||||0.05||||||This is the calculated p value and not the threshold for statistical significance.|t-test, 2 sided|||||||0.05
74090454|NCT03864042|147734365|OTHER||Geometric LS Mean Ratio|0.513|||||TWO_SIDED|90.0|0.449|0.587|||||Day 14 / Day -7|||0.587|0.449|
73997626|NCT02071290|147543084|SUPERIORITY|||||||0.967|||||||Mixed Models Analysis|||||||0.967
73997627|NCT02071290|147543085|SUPERIORITY|||||||0.637|||||||Mixed Models Analysis|||||||0.637
73997628|NCT02071290|147543086|SUPERIORITY|||||||0.664|||||||Mixed Models Analysis|||||||0.664
73997629|NCT02071290|147543087|SUPERIORITY|||||||0.661|||||||Mixed Models Analysis|||||||0.661
73997630|NCT02071290|147543088|SUPERIORITY|||||||0.916|||||||Mixed Models Analysis|||||||0.916
73997631|NCT02071290|147543089|SUPERIORITY|||||||0.437|||||||Mixed Models Analysis|||||||0.437
73997632|NCT02071290|147543090|SUPERIORITY|||||||0.353|||||||Mixed Models Analysis|||||||0.353
73997633|NCT02071290|147543091|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||||||0.99
73997634|NCT02071290|147543092|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||||||0.085
73997635|NCT02071290|147543093|SUPERIORITY|||||||0.371|||||||Mixed Models Analysis|||||||0.371
73997636|NCT02071290|147543094|SUPERIORITY|||||||0.106|||||||Mixed Models Analysis|||||||0.106
73997637|NCT02071290|147543095|SUPERIORITY|||||||0.829|||||||Mixed Models Analysis|||||||0.829
73997638|NCT02071290|147543096|SUPERIORITY|||||||0.323|||||||Wilcoxon (Mann-Whitney)|||||||0.323
73997639|NCT02071290|147543097|SUPERIORITY|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||||||0.287
73997640|NCT02071290|147543098|SUPERIORITY|||||||0.151|||||||Wilcoxon (Mann-Whitney)|||||||0.151
73997641|NCT02071290|147543099|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.510
73997642|NCT02071290|147543100|SUPERIORITY|||||||0.348|||||||Chi-squared|||||||0.348
73997643|NCT02071290|147543101|SUPERIORITY|||||||0.911|||||||Chi-squared|||||||0.911
73997644|NCT01072630|147543110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1302|TWO_SIDED|95.0|-4.67|0.6||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||0.60|-4.67|0.1302
73997645|NCT01072630|147543110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.135|TWO_SIDED|95.0|-4.51|0.61||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||0.61|-4.51|0.1350
73997646|NCT01232738|147543133|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.07|TWO_SIDED|95.0|-0.53|0.02|||Chi-squared|||Difference in slope of decline||0.02|-0.53|0.07
73997647|NCT01232738|147543134|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
73997648|NCT00338962|147543143|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Bonferonni adjustments were applied. Mixed effects models were used to assess changes in PTSD symptoms over time.|Mixed Models Analysis|F=49.633||||||0.00
73997649|NCT00338962|147543145|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANOVA|||Gastrointestinal symptoms compared||||0.007
74036274|NCT01975935|147624957|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
74036275|NCT01975935|147624958|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
74090455|NCT03864042|147734366|OTHER||Geometric LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.17|1.39|||||Day 1 / Day -7|||1.39|1.17|
73876909|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||0.6|-30.6|0.251
73876910|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Clinical non-responders, Week 44||3.1|-23.1|1.000
73876911|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-5.2||||0.606|TWO_SIDED|95.0|-21.2|10.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.8|-21.2|0.606
73876912|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-2.9||||1|TWO_SIDED|95.0|-21.7|16.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||16.0|-21.7|1.000
73997650|NCT02917603|147543153|EQUIVALENCE|Null hypothesis is that there would be no mean difference between baseline and last measure between intervention and control groups with p\<.05|Mean Difference (Net)|0.12|||<|0.009|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the mean differences between baseline and last measure in the PHQ- 9 score will not differ between groups. Study is powered a two-tailed test of significance, allowing the detection of a significant difference in either direction and the following assumptions: expected difference in PHQ-9 is 5 points, the documented clinically significant effect;78 (2) the variance of scores is 5.33; (3) error protection: α =.10, β = .20 and, (4) anticipated attrition of 15%||||<.009
73997651|NCT02917603|147543154|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.46|||<|0.21|TWO_SIDED||||||t-test, 2 sided|||||||<.21
73997652|NCT02917603|147543155|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|1.02|||<|0.06|TWO_SIDED||||||t-test, 2 sided|||||||<.06
73997653|NCT02917603|147543156|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.23|||<|0.73|TWO_SIDED||||||t-test, 2 sided|||||||<.73
73997654|NCT01253018|147543157|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||"Sample size and power calculations were performed based on the difference in the FM score between the two groups with an assumed within group SD of 15.9, the correlation of 0.5 among repeated measures. 30 subjects enrolled in each arm of the study would give 80% power for detecting a difference of 8 points on the FM.~Two sample t-tests were conducted to compare changes in FM between the two interventions groups at final training (12 week)."||||<0.05
73997655|NCT01253018|147543157|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in FM between the two interventions groups at retention (24 weeks).||||<0.05
73997656|NCT01253018|147543159|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at final training 12 week.||||<0.05
73997657|NCT01253018|147543159|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at retention 24 weeks.||||<0.05
73997658|NCT01253018|147543160|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at final training week 12.||||<0.05
73997659|NCT01253018|147543160|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at retention week 24.||||<0.05
73997660|NCT00422812|147543191|SUPERIORITY|||||||0.0012||||||Overall effect at 2 hr (by Cochran-Mantel-Haenszel) for TREATMENT|Cochran-Mantel-Haenszel|||||||0.0012
73997661|NCT00422812|147543192|SUPERIORITY|||||||0.281|||||||Fisher Exact|||||||0.281
73997662|NCT00422812|147543192|SUPERIORITY|||||||0.0226|||||||Fisher Exact|||||||0.0226
73997663|NCT00422812|147543192|SUPERIORITY|||||||0.0019|||||||Fisher Exact|||||||0.0019
73997664|NCT00422812|147543193|SUPERIORITY|||||||0.0007||||||Overall effect (0-4 hr) for TREATMENT by Log-rank p-value|Log Rank|There was no adjustment for multiple comparisons.||||||0.0007
73997665|NCT00422812|147543193|SUPERIORITY|||||||0.0008|||||||Log Rank|No adjustments were made for multiple comparisons||||||0.0008
73997666|NCT00422812|147543193|SUPERIORITY|||||||0.0008||||||No adjustments were made for multiple comparisons|Log Rank|||||||0.0008
73997667|NCT00422812|147543193|SUPERIORITY|||||||0.0003||||||No adjustments were made for multiple comparisons|Log Rank|||||||0.0003
73997668|NCT03691909|147543215|OTHER|||||||0.743|||||||Wilcoxon-signed rank test|Effect Size: 0.09||||||0.743
73997669|NCT03691909|147543216|OTHER|||||||0.714|||||||Wilcoxon-signed rank test|Effect Size: 0.10||||||0.714
73997670|NCT03691909|147543217|OTHER|||||||0.183|||||||Wilcoxon-signed rank test|Effect Size: 0.37||||||0.183
73997671|NCT03691909|147543218|OTHER|||||||0.775|||||||Wilcoxon-signed rank test|Effect Size: 0.05||||||0.775
73997672|NCT03691909|147543219|OTHER|||||||0.0008|||||||Wilcoxon-signed rank test|Effect Size: 0.93||Tender Joint Count||||0.0008
73997673|NCT03691909|147543219|OTHER|||||||0.003|||||||Wilcoxon-signed rank test|Effect Size: 0.83||Swollen Joint Count||||0.003
73997674|NCT05260021|147543224|SUPERIORITY||LS Mean difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|-2.35|-1.25|||ANCOVA|||||-1.25|-2.35|<0.001
73997675|NCT05260021|147543225|SUPERIORITY||LS Mean difference (Final Values)|-1.67|||<|0.001|TWO_SIDED|95.0|-2.31|-1.02|||ANCOVA|||||-1.02|-2.31|<0.001
73997676|NCT05260021|147543225|SUPERIORITY||LS Mean difference (Final Values)|-1.93|||<|0.001|TWO_SIDED|95.0|-2.57|-1.29|||ANCOVA|||||-1.29|-2.57|<0.001
74090456|NCT03864042|147734366|OTHER||Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.979|1.16|||||Day 14 / Day -7|||1.16|0.979|
73997677|NCT05260021|147543226|SUPERIORITY||Risk Difference (RD)|40.1|||<|0.001|TWO_SIDED|95.0|18.6|61.7|||Regression, Logistic|||||61.7|18.6|<0.001
73997678|NCT05260021|147543226|SUPERIORITY||Risk Difference (RD)|51.6|||<|0.001|TWO_SIDED|95.0|31.1|72.2|||Regression, Logistic|||||72.2|31.1|<0.001
74090457|NCT03864042|147734367|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.947|1.26|||||Day 1 / Day -7|||1.26|0.947|
73997679|NCT05260021|147543226|SUPERIORITY||Risk Difference (RD)|45.8|||<|0.001|TWO_SIDED|95.0|27.5|64.1|||Regression, Logistic|||||64.1|27.5|<0.001
73997680|NCT05260021|147543227|SUPERIORITY||LS Mean difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.55|-0.16|||ANCOVA|||||-0.16|-0.55|< 0.001
73997681|NCT05260021|147543227|SUPERIORITY||LS Mean difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.86|-0.47|||ANCOVA|||||-0.47|-0.86|<0.001
73997682|NCT05260021|147543227|SUPERIORITY||LS Mean difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.34|||ANCOVA|||||-0.34|-0.68|< 0.001
73997683|NCT05260021|147543228|SUPERIORITY||LS Mean difference (Final Values)|-28.9||||0.007|TWO_SIDED|95.0|-49.7|-8.0|||ANCOVA|||||-8.0|-49.7|0.007
73997684|NCT05260021|147543228|SUPERIORITY||LS Mean difference (Final Values)|-44.0|||<|0.001|TWO_SIDED|95.0|-64.3|-23.6|||ANCOVA|||||-23.6|-64.3|< 0.001
73997685|NCT05260021|147543228|SUPERIORITY||LS Mean difference (Final Values)|-36.4|||<|0.001|TWO_SIDED|95.0|-54.2|-18.6|||ANCOVA|||||-18.6|-54.2|< 0.001
73997686|NCT05260021|147543229|SUPERIORITY||LS Mean difference (Final Values)|-6.18|||<|0.001|TWO_SIDED|95.0|-9.31|-3.05|||ANCOVA|||||-3.05|-9.31|< 0.001
73997687|NCT05260021|147543229|SUPERIORITY||LS Mean difference (Final Values)|-10.52|||<|0.001|TWO_SIDED|95.0|-13.67|-7.38|||ANCOVA|||||-7.38|-13.67|< 0.001
73997688|NCT05260021|147543229|SUPERIORITY||LS Mean difference (Final Values)|-8.35|||<|0.001|TWO_SIDED|95.0|-11.05|-5.66|||ANCOVA|||||-5.66|-11.05|< 0.001
73997689|NCT05260021|147543230|SUPERIORITY||Risk Difference (RD)|29.5||||0.006|TWO_SIDED|95.0|8.6|50.3|||Regression, Logistic|||||50.3|8.6|0.006
73997690|NCT05260021|147543230|SUPERIORITY||Risk Difference (RD)|39.5|||<|0.001|TWO_SIDED|95.0|18.8|60.2|||Regression, Logistic|||||60.2|18.8|< 0.001
73997691|NCT05260021|147543230|SUPERIORITY||Risk Difference (RD)|34.6|||<|0.001|TWO_SIDED|95.0|17.0|52.1|||Regression, Logistic|||||52.1|17|< 0.001
73997692|NCT05260021|147543231|SUPERIORITY||Risk Difference (RD)|43.4|||<|0.001|TWO_SIDED|95.0|22.3|64.4|||Regression, Logistic|||||64.4|22.3|< 0.001
73997693|NCT05260021|147543231|SUPERIORITY||Risk Difference (RD)|47.1|||<|0.001|TWO_SIDED|95.0|26.4|67.7|||Regression, Logistic|||||67.7|26.4|< 0.001
73997694|NCT05260021|147543231|SUPERIORITY||Risk Difference (RD)|45.2|||<|0.001|TWO_SIDED|95.0|26.3|64.1|||Regression, Logistic|||||64.1|26.3|< 0.001
74090458|NCT03864042|147734367|OTHER||Geometric LS Mean Ratio|1.27|||||TWO_SIDED|90.0|1.1|1.46|||||Day 14 / Day -7|||1.46|1.10|
74090459|NCT03864042|147734368|OTHER||Geometric LS Mean Ratio|1.12|||||TWO_SIDED|90.0|1.02|1.23|||||Day 1 / Day -7|||1.23|1.02|
73997695|NCT05260021|147543233|SUPERIORITY||LS Mean difference (Final Values)|0.014||||0.708|TWO_SIDED|95.0|-0.061|0.089|||Mixed Models Analysis|||||0.089|-0.061|0.708
73997696|NCT05260021|147543233|SUPERIORITY||LS Mean difference (Final Values)|-0.001||||0.976|TWO_SIDED|95.0|-0.076|0.074|||Mixed Models Analysis|||||0.074|-0.076|0.976
73997697|NCT05260021|147543233|SUPERIORITY||LS Mean difference (Final Values)|0.007||||0.841|TWO_SIDED|95.0|-0.058|0.071|||Mixed Models Analysis|||||0.071|-0.058|0.841
73997698|NCT05260021|147543234|SUPERIORITY||LS Mean difference (Final Values)|-0.29|||<|0.001|TWO_SIDED|95.0|-0.45|-0.12|||Mixed Models Analysis|||||-0.12|-0.45|< 0.001
73997699|NCT05260021|147543234|SUPERIORITY||LS Mean difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.57|-0.24|||Mixed Models Analysis|||||-0.24|-0.57|< 0.001
73997700|NCT05260021|147543234|SUPERIORITY||LS Mean difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.49|-0.2|||Mixed Models Analysis|||||-0.2|-0.49|< 0.001
73997701|NCT04679935|147543266|OTHER|Analysis was purely descriptive.|Difference|-3.74|STANDARD_ERROR_OF_MEAN|1.84|||TWO_SIDED|95.0|-7.47|-0.01|||MMRM model|||Week 40||-0.01|-7.47|
73997702|NCT04679935|147543266|OTHER|Analysis was purely descriptive.|Difference|-4.15|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-8.78|-0.48|||MMRM model|||Week 44||-0.48|-8.78|
73997703|NCT04679935|147543266|OTHER|Analysis was purely descriptive.|Difference|-5.35|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-10.13|-0.58|||MMRM model|||Week 48||-0.58|-10.13|
73997704|NCT04679935|147543266|OTHER|Analysis was purely descriptive.|Difference|-4.19|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-8.77|0.39|||MMRM model|||Week 52||0.39|-8.77|
73997705|NCT04679935|147543266|OTHER|Analysis was purely descriptive.|Difference|-4.36|STANDARD_ERROR_OF_MEAN|2.09|||TWO_SIDED|95.0|-8.56|-0.16|||MMRM model|||Mean of Week 40 to Week 52||-0.16|-8.56|
73997706|NCT04679935|147543274|OTHER|Analysis was purely descriptive.|Difference|-4.19|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-8.77|-0.39|||MMRM model|||Week 52||-0.39|-8.77|
73997707|NCT04362189|147543292|SUPERIORITY||Slope|-1.93|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
73997708|NCT04362189|147543293|SUPERIORITY||Slope|-1.31|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|||||
73997709|NCT04362189|147543294|SUPERIORITY||Slope|1.36|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
73997710|NCT04362189|147543295|SUPERIORITY||Slope|0.23|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
73997711|NCT04362189|147543296|SUPERIORITY||Slope|-0.15|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
73997712|NCT04362189|147543297|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED||||||||HB-adMSCs represents Numerator and Placebo represents Denominator.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
74090460|NCT03864042|147734368|OTHER||Geometric LS Mean Ratio|1.26|||||TWO_SIDED|90.0|1.14|1.38|||||Day 14 / Day -7|||1.38|1.14|
74090461|NCT03864042|147734369|OTHER||Geometric LS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.721|1.12|||||Day 1 / Day -7|||1.12|0.721|
74090462|NCT03864042|147734369|OTHER||Geometric LS Mean Ratio|0.679|||||TWO_SIDED|90.0|0.544|0.848|||||Day 14 / Day -7|||0.848|0.544|
74090463|NCT03864042|147734370|OTHER||Geometric LS Mean Ratio|1.26|||||TWO_SIDED|90.0|0.8|1.98|||||Day 1 / Day -7|||1.98|0.800|
73997713|NCT04362189|147543304|SUPERIORITY||Slope|-0.17|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
73997714|NCT04362189|147543305|SUPERIORITY||Slope|0.55|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
73997715|NCT04362189|147543306|SUPERIORITY||Slope|0.26|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
73997716|NCT04362189|147543307|SUPERIORITY||Slope|0.81|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
73997717|NCT05116540|147543367|SUPERIORITY||Mean Difference (Final Values)|22.121|STANDARD_ERROR_OF_MEAN|4.616||0.0002|TWO_SIDED|95.0|12.282|31.959|||ANCOVA|||||31.959|12.282|0.0002
73997718|NCT05116540|147543368|SUPERIORITY||Mean Difference (Final Values)|15.764|STANDARD_ERROR_OF_MEAN|5.844||0.0166|TWO_SIDED|95.0|3.307|28.221|||ANCOVA|||||28.221|3.307|0.0166
73997719|NCT05116540|147543369|SUPERIORITY||Mean Difference (Final Values)|22.137|STANDARD_DEVIATION|4.962||0.9905|TWO_SIDED|95.0|12.361|32.006|||ANCOVA|||||32.006|12.361|0.9905
73997720|NCT05116540|147543370|SUPERIORITY||Mean Difference (Final Values)|15.747|STANDARD_DEVIATION|6.274||0.8292|TWO_SIDED|95.0|3.329|28.177|||ANCOVA|||||28.177|3.329|0.8292
73997721|NCT05116540|147543371|SUPERIORITY||Mean Difference (Final Values)|-1.554|STANDARD_ERROR_OF_MEAN|0.638||0.0278|TWO_SIDED|95.0|-2.914|-0.195|||ANCOVA|||||-0.195|-2.914|0.0278
73997722|NCT05116540|147543372|SUPERIORITY||Mean Difference (Final Values)|5.453|STANDARD_ERROR_OF_MEAN|2.757||0.0666|TWO_SIDED|95.0|-0.424|11.33|||ANCOVA|||||11.330|-0.424|0.0666
73997723|NCT05116540|147543373|SUPERIORITY||Mean Difference (Final Values)|10.112|STANDARD_ERROR_OF_MEAN|5.508||0.0863|TWO_SIDED|95.0|-1.629|21.853|||ANCOVA|||||21.853|-1.629|0.0863
73997724|NCT05116540|147543374|SUPERIORITY||Mean Difference (Final Values)|0.977|STANDARD_ERROR_OF_MEAN|1.633||0.5588|TWO_SIDED|95.0|-2.504|4.457|||ANCOVA|||||4.457|-2.504|0.5588
73997725|NCT05116540|147543375|SUPERIORITY||Mean Difference (Final Values)|-4.593|STANDARD_ERROR_OF_MEAN|1.023||0.0004|TWO_SIDED|95.0|-6.773|-2.413|||ANCOVA|||||-2.413|-6.773|0.0004
73997726|NCT04348435|147543412|SUPERIORITY||Mean Difference (Net)|0.253|STANDARD_ERROR_OF_MEAN|0.49||0.6113|TWO_SIDED|95.0|||||ANCOVA|||||||0.6113
73997727|NCT04348435|147543412|SUPERIORITY||Mean Difference (Net)|-0.434|STANDARD_ERROR_OF_MEAN|0.638||0.5039|TWO_SIDED|95.0|||||ANCOVA|||||||0.5039
73997728|NCT04348435|147543412|SUPERIORITY||Mean Difference (Net)|0.077|STANDARD_ERROR_OF_MEAN|0.555||0.8903|TWO_SIDED|95.0|||||ANCOVA|||||||0.8903
74036276|NCT01419665|147624970|EQUIVALENCE|The equivalence margin of + or - 12% was determined considering the variability of the point estimate of the add-on effect by taking a value lower than the lower boundary of the 95% CI for Rituximab+chemotherapy versus chemotherapy obtained from historical data.|difference in overall response rate|-0.4|||||TWO_SIDED|95.0|-5.94|5.14|||Binomial approximation|||||5.14|-5.94|
73997729|NCT04348435|147543413|SUPERIORITY||Mean Difference (Net)|-0.247|STANDARD_ERROR_OF_MEAN|1.056||0.8171|TWO_SIDED|95.0|||||ANCOVA|||||||0.8171
73997730|NCT04348435|147543413|SUPERIORITY||Mean Difference (Net)|-0.913|STANDARD_ERROR_OF_MEAN|1.342||0.5034|TWO_SIDED|95.0|||||ANCOVA|||||||0.5034
73997731|NCT04348435|147543413|SUPERIORITY||Mean Difference (Net)|0.008|STANDARD_ERROR_OF_MEAN|1.193||0.9948|TWO_SIDED|95.0|||||ANCOVA|||||||0.9948
73997732|NCT04348435|147543414|SUPERIORITY||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.156||0.2641|TWO_SIDED|95.0|||||ANCOVA|||||||0.2641
73997733|NCT04348435|147543414|SUPERIORITY||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.198||0.822|TWO_SIDED|95.0|||||ANCOVA|||||||0.8220
73997734|NCT04348435|147543414|SUPERIORITY||Median Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.171||0.3097|TWO_SIDED|95.0|||||ANCOVA|||||||0.3097
73997735|NCT04348435|147543415|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.07||1|TWO_SIDED|95.0|||||ANCOVA|||||||1.000
73997736|NCT04348435|147543415|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.087||1|TWO_SIDED|95.0|||||ANCOVA|||||||1.000
73997737|NCT04348435|147543415|SUPERIORITY||Mean Difference (Net)|0.112|STANDARD_ERROR_OF_MEAN|0.079||0.1713|TWO_SIDED|95.0|||||ANCOVA|||||||0.1713
73997738|NCT04348435|147543416|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.091||0.3868|TWO_SIDED|95.0|||||ANCOVA|||||||0.3868
73997739|NCT04348435|147543416|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|0.115||0.9429|TWO_SIDED|95.0|||||ANCOVA|||||||0.9429
73997740|NCT04348435|147543416|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|0.103||0.9362|TWO_SIDED|95.0|||||ANCOVA|||||||0.9362
73997741|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|-0.708|STANDARD_ERROR_OF_MEAN|8.38||0.9333|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.9333
73997742|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|8.78|STANDARD_ERROR_OF_MEAN|9.483||0.3627|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.3627
73997743|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|6.282|STANDARD_ERROR_OF_MEAN|7.604||0.416|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.4160
73997744|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|3.32||0.8768|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.8768
73997745|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|-7.719|STANDARD_ERROR_OF_MEAN|4.344||0.0869|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.0869
73997746|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|1.434|STANDARD_ERROR_OF_MEAN|3.514||0.6864|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.6864
73997747|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|-4.12|STANDARD_ERROR_OF_MEAN|3.571||0.2587|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.2587
73997748|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|8.417|STANDARD_ERROR_OF_MEAN|5.316||0.125|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.1250
73997749|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|-0.104|STANDARD_ERROR_OF_MEAN|3.732||0.978|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.9780
73997750|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|0.963|STANDARD_ERROR_OF_MEAN|5.925||0.8721|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.8721
73997751|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|3.34|STANDARD_ERROR_OF_MEAN|7.735||0.6694|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.6694
73997752|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|5.498|STANDARD_ERROR_OF_MEAN|6.073||0.3733|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.3733
73997753|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|2.433|STANDARD_ERROR_OF_MEAN|4.116||0.5594|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.5594
73997754|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|6.878|STANDARD_ERROR_OF_MEAN|5.389||0.2127|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.2127
74036277|NCT01419665|147624973|OTHER|descriptive purposes, not powered for hypothesis testing|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.97|1.76|||Regression, Cox|||||1.76|0.97|
74036278|NCT01419665|147624974|OTHER|descriptive purposes, not powered for hypothesis testing|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.55|1.52|||Regression, Cox|||||1.52|0.55|
74036279|NCT01752842|147625009|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-0.75||||0.07|TWO_SIDED|95.0|-1.56|0.04||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of cardiac diastolic function adjusting for body fat percent, baseline values of BMI, diastolic/systolic blood pressure, HbA1c, fasting glucose, triglycerides, ethnicity, gender and race.|Null hypothesis is no difference of mean change of cardiac diastolic function as measured by E' (cm/s) between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|0.04|-1.56|0.07
74090464|NCT03864042|147734370|OTHER||Geometric LS Mean Ratio|0.827|||||TWO_SIDED|90.0|0.526|1.3|||||Day 14 / Day -7|||1.30|0.526|
73997755|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|3.67|STANDARD_ERROR_OF_MEAN|4.303||0.4012|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.4012
73997756|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|11.678|STANDARD_ERROR_OF_MEAN|5.748||0.0521|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.0521
73997757|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|5.635|STANDARD_ERROR_OF_MEAN|7.696||0.4704|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.4704
73997758|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|12.101|STANDARD_ERROR_OF_MEAN|6.017||0.0544|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.0544
73997759|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|2.333|STANDARD_ERROR_OF_MEAN|3.888||0.5535|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.5535
74036280|NCT01752842|147625010|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|0.0058||||0.8128|TWO_SIDED|95.0|-0.0418|0.0543||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.|Null hypothesis is no difference of mean change of fractional shortening percent between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|0.0543|-0.0418|0.8128
73997760|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|3.689|STANDARD_ERROR_OF_MEAN|4.969||0.4642|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.4642
73997761|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|2.268|STANDARD_ERROR_OF_MEAN|3.936||0.5692|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.5692
73997762|NCT04348435|147543417|SUPERIORITY||Median Difference (Net)|2.667|STANDARD_ERROR_OF_MEAN|3.592||0.4642|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||0.4642
74036281|NCT01752842|147625011|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-1.79||||0.0034|TWO_SIDED|95.0|-2.93|-0.65||This P-value is based on ANCOVA.|ANCOVA|ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.||Null hypothesis is no difference of mean change of C24:0/C16:0 ceramide ratio between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|-0.65|-2.93|0.0034
74036282|NCT01683071|147625012|SUPERIORITY||LSMD|2.9||||0.9494|TWO_SIDED|95.0|-88.0|94.0|||ANCOVA|||||94|-88|0.9494
74036283|NCT01683071|147625012|SUPERIORITY||LSMD|-103.3||||0.0237|TWO_SIDED|95.0|-192.0|-14.0|||ANCOVA|||||-14|-192|0.0237
74036284|NCT01683071|147625012|SUPERIORITY||LSMD|-94.3||||0.0386|TWO_SIDED|95.0|-184.0|-5.0|||ANCOVA|||||-5|-184|0.0386
74036285|NCT01683071|147625012|SUPERIORITY||LSMD|-96.5|||<|0.0001|TWO_SIDED|95.0|-144.0|-49.0|||ANCOVA|||||-49|-144|<0.0001
74036286|NCT01683071|147625013|SUPERIORITY||Geometric LSM ratio|0.9||||0.6182|TWO_SIDED|95.0|0.6|1.3|||ANOVA|||||1.3|0.6|0.6182
74036287|NCT01683071|147625013|SUPERIORITY||Geometric LSM ratio|0.73||||0.1097|TWO_SIDED|95.0|0.5|1.1|||ANOVA|||||1.1|0.5|0.1097
74036288|NCT01683071|147625013|SUPERIORITY||Geometric LSM ratio|0.85||||0.4046|TWO_SIDED|95.0|0.6|1.3|||ANOVA|||||1.3|0.6|0.4046
74090465|NCT03864042|147734371|OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.688|1.39|||||Day 1 / Day -7|||1.39|0.688|
74090466|NCT03864042|147734371|OTHER||Geometric LS Mean Ratio|0.633|||||TWO_SIDED|90.0|0.445|0.9|||||Day 14 / Day -7|||0.900|0.445|
74090467|NCT03864042|147734372|OTHER||Geometric LS Mean Ratio|2.79|||||TWO_SIDED|90.0|2.08|3.74|||||Day 1 / Day -7|||3.74|2.08|
73997763|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|4.444||1|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||1.0000
73876913|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|1.000
73876914|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||17.7|-18.7|1.000
73997764|NCT04348435|147543417|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|3.526||1|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||1.0000
73997765|NCT04348435|147543418|SUPERIORITY||Mean Difference (Net)|-0.144|STANDARD_ERROR_OF_MEAN|0.825||0.8628|TWO_SIDED|95.0|||||ANCOVA|||||||0.8628
73997766|NCT04348435|147543418|SUPERIORITY||Mean Difference (Net)|-0.605|STANDARD_ERROR_OF_MEAN|0.94||0.5257|TWO_SIDED|95.0|||||ANCOVA|||||||0.5257
73997767|NCT04348435|147543418|SUPERIORITY||Mean Difference (Net)|-0.403|STANDARD_ERROR_OF_MEAN|0.659||0.5467|TWO_SIDED|95.0|||||ANCOVA|||||||0.5467
73997768|NCT03333876|147543427|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Each group was compared to baseline.||||<.001
73997769|NCT00095498|147543432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.264|||||||van Elteren stratified rank test|||||||0.264
73997770|NCT00095498|147543432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||van Elteren stratified rank test|||||||0.018
73997771|NCT00095498|147543433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|||||||van Elteren Stratified Rank Test|||||||0.032
73997772|NCT00095498|147543433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||van Elteren Stratified Rank Test|||||||0.180
73997773|NCT00095498|147543434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.602|||||||van Elteren Stratified Rank Test|||||||0.602
73997774|NCT00095498|147543434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||van Elteren Stratified Rank Test|||||||0.181
73997775|NCT00095498|147543435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||van Elteren Stratified Rank Test|||||||0.012
73997776|NCT00095498|147543435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||van Elteren Stratified Rank Test|||||||0.007
73876915|NCT02365649|147294851|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|0.501
73997777|NCT00095498|147543436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277|||||||van Elteren Stratified Rank Test|||||||0.277
73997778|NCT00095498|147543436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||van Elteren Stratified Rank Test|||||||0.019
73997779|NCT00095498|147543437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.382|||||||van Elteren Stratified Rank Test|||||||0.382
73997780|NCT00095498|147543437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.488|||||||van Elteren Stratified Rank Test|||||||0.488
73997781|NCT00095498|147543438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|||||||van Elteren Stratified Rank Test|||||||0.236
73997782|NCT00095498|147543438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.712|||||||van Elteren Stratified Rank Test|||||||0.712
73997783|NCT00095498|147543439|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93||||0.026||95.0|0.11|1.74|||Repeated Measures Model|||||1.74|0.11|0.026
73997784|NCT00095498|147543439|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.59||||0.155||95.0|-0.23|1.41|||Repeated measures model|||||1.41|-0.23|0.155
73997785|NCT00095498|147543440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.67||||0.002||95.0|0.62|2.72|||Repeated Measures Model|||||2.72|0.62|0.002
73997786|NCT00095498|147543440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.89|||<|0.001||95.0|0.84|2.94|||Repeated Measures Model|||||2.94|0.84|<0.001
73997787|NCT00095498|147543441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|||<|0.001||95.0|1.1|3.29|||Repeated Measures Model|||||3.29|1.1|<0.001
73997788|NCT00095498|147543441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.29|||<|0.001||95.0|2.18|4.39|||Repeated Measures Model|||||4.39|2.18|<0.001
73997789|NCT00095498|147543442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.986||95.0|-1.06|1.08|||Repeated Measures Model|||||1.08|-1.06|0.986
73997790|NCT00095498|147543442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.141||95.0|-0.27|1.86|||Repeated Measures Model|||||1.86|-0.27|0.141
73997791|NCT00095498|147543443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.95||||0.073||95.0|-0.09|1.99|||Repeated Measures Model|||||1.99|-0.09|0.073
73997792|NCT00095498|147543443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89||||0.09||95.0|-0.14|1.93|||Repeated Measures Model|||||1.93|-0.14|0.09
73997793|NCT00095498|147543444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.81||||0.007||95.0|0.51|3.12|||Repeated Measures Model|||||3.12|0.51|0.007
73997794|NCT00095498|147543444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.98||||0.003||95.0|0.67|3.29|||Repeated Measures Model|||||3.29|0.67|0.003
73997795|NCT00095498|147543445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.938||95.0|-0.58|0.63|||Repeated Measures Model|||||0.63|-0.58|0.938
73997796|NCT00095498|147543445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08||||0.787||95.0|-0.53|0.69|||Repeated Measures Model|||||0.69|-0.53|0.787
73997797|NCT00095498|147543446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.004||95.0|0.33|1.67|||Repeated Measures Model|||||1.67|0.33|0.004
73997798|NCT00095498|147543446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18|||<|0.001||95.0|0.51|1.85|||Repeated Measures Model|||||1.85|0.51|<0.001
73997799|NCT00095498|147543447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.94|||<|0.001||95.0|1.02|2.85|||Repeated Measures Model|||||2.85|1.02|<0.001
74036289|NCT01683071|147625013|SUPERIORITY||Geometric LSM ratio|0.74||||0.0016|TWO_SIDED|95.0|0.6|0.9|||ANOVA|||||0.9|0.6|0.0016
74036290|NCT01968187|147625042|OTHER||LS Mean Difference|-6.7||||0.029|ONE_SIDED|90.0||-2.2|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effect and HPWSQ-R total score at baseline as covariate.||||-2.2||0.0290
74036291|NCT01968187|147625043|OTHER||LS Mean Difference|-0.8||||0.0233|ONE_SIDED|90.0||-0.3|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and CGI-S score as a covariate.||||-0.3||0.0233
74036292|NCT01968187|147625044|OTHER||LS Mean Difference|-2.0||||0.1172|ONE_SIDED|90.0||0.2|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score at baseline as a covariate.||HPWSQ-R Domain score: Behavior||0.2||0.1172
73876916|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|17.5||||0.633|TWO_SIDED|95.0|-13.0|48.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||48.0|-13.0|0.633
73997800|NCT00095498|147543447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.04|||<|0.001||95.0|1.13|2.96|||Repeated Measures Model|||||2.96|1.13|<0.001
73997801|NCT00095498|147543448|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997802|NCT00095498|147543448|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997803|NCT00095498|147543449|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997804|NCT00095498|147543449|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997805|NCT00095498|147543450|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997806|NCT00095498|147543450|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997807|NCT00095498|147543451|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997808|NCT00095498|147543451|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997809|NCT00095498|147543452|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
74036293|NCT01968187|147625044|OTHER||LS Mean Difference|-1.6||||0.1436|ONE_SIDED|90.0||0.3|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score -at baseline as a covariate.||HPWSQ-R Domain score: Drive||0.3||0.1436
74036294|NCT01968187|147625044|OTHER||LS Mean Difference|-1.5||||0.0248|ONE_SIDED|90.0||-0.5|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score -at baseline as a covariate.||HPWSQ-R Domain score: Severity||-0.5||0.0248
73997810|NCT00095498|147543452|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997811|NCT00095498|147543453|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|||||||van Elteren Stratified Rank Test|||||||0.016
73997812|NCT00095498|147543453|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997813|NCT00095498|147543454|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997814|NCT00095498|147543454|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
73997815|NCT00095498|147543455|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|||||||van Elteren Stratified Rank Test|||||||0.673
74036295|NCT01968187|147625045|OTHER||LS mean difference|-6.2||||0.0047|ONE_SIDED|90.0||-3.3|||ANCOVA|From ANCOVA model with treatment and site as fixed effects and CY-BOCS total score at baseline as a covariate.||||-3.3||0.0047
74036296|NCT01968187|147625046|OTHER||LS mean difference|-4.4||||0.0132|ONE_SIDED|90.0||-1.9|||ANCOVA|Compared using ANCOVA model with treatment and site as fixed effects and Food Domain Score of Reiss Profile at baseline as a covariate.||||-1.9||0.0132
74036297|NCT04095286|147625051|OTHER||Ratio of adjusted geometric mean|1.03|||||TWO_SIDED|90.0|0.96|1.11|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.11|0.96|
74036298|NCT04095286|147625051|OTHER||Ratio of adjusted geometric mean|0.91|||||TWO_SIDED|90.0|0.85|0.98|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||0.98|0.85|
74036299|NCT04095286|147625054|OTHER||Ratio of adjusted geometric mean|1.05|||||TWO_SIDED|90.0|1.02|1.09|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.09|1.02|
73997816|NCT00095498|147543455|SUPERIORITY_OR_OTHER_LEGACY|||||||0.589|||||||van Elteren Stratified Rank Test|||||||0.589
73997817|NCT00095498|147543456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||van Elteren Stratified Rank Test|||||||0.175
73997818|NCT00095498|147543456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.133|||||||van Elteren Stratified Rank Test|||||||0.133
73997819|NCT03439254|147543589|OTHER||Response ratio(Mantel-Haenszel estimate)|1.13||||0.6172|TWO_SIDED|95.0|0.71|1.79|||Cochran-Mantel-Haenszel||Treatment / Placebo Response Ratio = Percentage of Responders in Active Treatment Arm / Percentage of Responders in Placebo, stratified by Baseline diabetes status (yes/no).|||1.79|0.71|0.6172
73997820|NCT03439254|147543589|OTHER||Response ratio(Mantel-Haenszel estimate)|1.2||||0.4184|TWO_SIDED|95.0|0.77|1.89|||Cochran-Mantel-Haenszel||Treatment / Placebo Response Ratio = Percentage of Responders in Active Treatment Arm / Percentage of Responders in Placebo, stratified by Baseline diabetes status (yes/no).|||1.89|0.77|0.4184
73997821|NCT02075476|147543603|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.048|||||||Mixed Models Analysis|||||||0.048
73997822|NCT02075476|147543604|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.001|||||||Mixed Models Analysis|||||||0.001
73997823|NCT02075476|147543605|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.011|||||||Mixed Models Analysis|||||||0.011
73997824|NCT02731690|147543625|SUPERIORITY|||||||0.5303||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.5303
73876917|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|30.0||||0.0024|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.0024
73876918|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-34.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||34.8|-34.8|1.000
73876919|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-39.8|29.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||29.8|-39.8|1.000
73997825|NCT02731690|147543625|SUPERIORITY|||||||0.1646||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.1646
73997826|NCT02731690|147543625|SUPERIORITY|||||||0.1189||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.1189
73997827|NCT02731690|147543625|SUPERIORITY|||||||0.0706||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0706
73997828|NCT02731690|147543626|SUPERIORITY|||||||0.0715||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0715
73997829|NCT02731690|147543626|SUPERIORITY|||||||0.1697||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.1697
73997830|NCT02731690|147543626|SUPERIORITY|||||||0.3428||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.3428
73997831|NCT02731690|147543626|SUPERIORITY|||||||0.0642||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0642
73876920|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-24.7|27.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||27.2|-24.7|1.000
73876921|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-20.0||||0.384|TWO_SIDED|95.0|-55.1|15.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||15.1|-55.1|0.384
73997832|NCT02731690|147543627|SUPERIORITY|||||||0.0568||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0568
73997833|NCT02731690|147543627|SUPERIORITY|||||||0.0533||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0533
73997834|NCT02731690|147543627|SUPERIORITY|||||||0.0459||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0459
73997835|NCT02731690|147543627|SUPERIORITY|||||||0.5678||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.5678
73997836|NCT02731690|147543628|SUPERIORITY|||||||0.581||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.5810
73997837|NCT02731690|147543628|SUPERIORITY|||||||0.0465||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0465
73997838|NCT02731690|147543628|SUPERIORITY|||||||0.1047||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.1047
73997839|NCT02731690|147543628|SUPERIORITY|||||||0.0661||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0661
74036300|NCT04095286|147625054|OTHER||Ratio of adjusted geometric mean|1.04|||||TWO_SIDED|90.0|1.0|1.08|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.08|1.00|
73997840|NCT02731690|147543629|SUPERIORITY|||||||0.1615||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.1615
73997841|NCT02731690|147543629|SUPERIORITY|||||||0.6201||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.6201
73997842|NCT02731690|147543629|SUPERIORITY|||||||0.9229||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.9229
73997843|NCT02731690|147543629|SUPERIORITY|||||||0.6307||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.6307
73997844|NCT02731690|147543630|SUPERIORITY|||||||0.0088||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0088
73997845|NCT02731690|147543630|SUPERIORITY|||||||0.2213||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.2213
73997846|NCT02731690|147543630|SUPERIORITY|||||||0.018||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0180
73997847|NCT02731690|147543630|SUPERIORITY|||||||0.197||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.1970
73997848|NCT02731690|147543631|SUPERIORITY|||||||0.0752||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0752
73997849|NCT02731690|147543631|SUPERIORITY|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.6403||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.6403
74090468|NCT03864042|147734372|OTHER||Geometric LS Mean Ratio|1.57|||||TWO_SIDED|90.0|1.17|2.11|||||Day 14 / Day -7|||2.11|1.17|
73997850|NCT02731690|147543631|SUPERIORITY|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.2316||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.2316
73997851|NCT02731690|147543631|SUPERIORITY|||||||0.7635||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.7635
73997852|NCT02731690|147543632|SUPERIORITY|||||||0.0872||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0872
73997853|NCT02731690|147543632|SUPERIORITY|||||||0.0073||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0073
73997854|NCT02731690|147543632|SUPERIORITY|||||||0.0086||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0086
73997855|NCT02731690|147543632|SUPERIORITY|||||||0.0489||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0489
73997856|NCT00923260|147543634|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||t-test, 2 sided|||||||0.79
73997857|NCT00923260|147543635|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.49
73997858|NCT00923260|147543636|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
73997859|NCT00923260|147543637|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||||||.86
73997860|NCT00923260|147543638|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
73997861|NCT00923260|147543639|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|||||||0.76
73997862|NCT00923260|147543640|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||||||0.45
73997863|NCT00923260|147543641|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||||||0.81
73997864|NCT00923260|147543642|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||t-test, 2 sided|||||||0.92
73997865|NCT00923260|147543643|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
73997866|NCT00923260|147543644|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|||||||0.15
73997867|NCT00923260|147543645|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 2 sided|||||||0.20
74090469|NCT03864042|147734373|OTHER||Geometric LS Mean Ratio|0.769|||||TWO_SIDED|90.0|0.637|0.928|||||Day 1 / Day -7|||0.928|0.637|
74090470|NCT03864042|147734373|OTHER||Geometric LS Mean Ratio|0.736|||||TWO_SIDED|90.0|0.61|0.889|||||Day 14 / Day -7|||0.889|0.610|
74090471|NCT03864042|147734374|OTHER||Geometric LS Mean Ratio|0.993|||||TWO_SIDED|90.0|0.803|1.23|||||Day 1 / Day -7|||1.23|0.803|
73876922|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.281
73876923|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
73876924|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-35.0||||0.108|TWO_SIDED|95.0|-70.8|0.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||0.8|-70.8|0.108
73997868|NCT00923260|147543646|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
73997869|NCT00923260|147543647|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||t-test, 2 sided|||||||0.92
73997870|NCT00923260|147543648|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
73997871|NCT00923260|147543649|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||||||0.21
73997872|NCT00923260|147543650|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|||||||0.65
73997873|NCT00923260|147543651|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||t-test, 2 sided|||||||0.33
73997874|NCT00923260|147543652|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||t-test, 2 sided|||||||0.39
73997875|NCT00923260|147543653|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||||||0.47
73876925|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|12.5||||0.686|TWO_SIDED|95.0|-27.6|52.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||52.6|-27.6|0.686
73997876|NCT00923260|147543654|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||t-test, 2 sided|||||||0.75
73997877|NCT00923260|147543655|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||||||0.94
73997878|NCT00923260|147543656|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||||||0.74
73997879|NCT00923260|147543657|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
73876926|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|25.0||||0.126|TWO_SIDED|95.0|-5.5|55.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.5|-5.5|0.126
73876927|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||27.4|-47.4|0.709
73997880|NCT00923260|147543658|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||t-test, 2 sided|||||||0.67
73997881|NCT00923260|147543659|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
73997882|NCT00923260|147543660|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||||||0.038
73997883|NCT00923260|147543661|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||||||0.14
73997884|NCT00923260|147543662|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||||||0.21
73997885|NCT00923260|147543663|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||||||0.42
73997886|NCT00923260|147543664|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||t-test, 2 sided|||||||0.18
73997887|NCT00923260|147543665|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
73997888|NCT00923260|147543666|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
73997889|NCT00923260|147543667|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||t-test, 2 sided|||||||0.18
73997890|NCT00923260|147543668|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|||||||0.40
73997891|NCT00923260|147543669|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
73997892|NCT00923260|147543670|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||||||0.035
73997893|NCT00923260|147543671|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
73997894|NCT00923260|147543672|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||t-test, 2 sided|||||||0.99
73997895|NCT00923260|147543673|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
73997896|NCT00923260|147543674|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
73997897|NCT00923260|147543675|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||t-test, 2 sided|||||||0.97
73997898|NCT00923260|147543676|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||||||0.85
73997899|NCT00923260|147543677|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||||||0.61
73997900|NCT00923260|147543678|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||||||0.55
73997901|NCT00923260|147543679|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|||||||0.65
73997902|NCT00923260|147543680|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||||||0.74
73997903|NCT00923260|147543681|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||||||0.57
73997904|NCT00923260|147543682|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||t-test, 2 sided|||||||0.87
73997905|NCT00923260|147543683|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||||||0.28
73997906|NCT00923260|147543684|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
73997907|NCT00923260|147543685|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||||||0.42
73997908|NCT00923260|147543686|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
73876928|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|37.5||||0.099|TWO_SIDED|95.0|5.8|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||69.2|5.8|0.099
73876929|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||50.3|-12.8|0.257
73876930|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-38.0|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||38.0|-38.0|1.000
73997909|NCT00923260|147543687|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||||||0.68
73997910|NCT00923260|147543688|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
73997911|NCT00923260|147543689|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||t-test, 2 sided|||||||0.71
73997912|NCT00923260|147543690|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 2 sided|||||||0.32
73997913|NCT00923260|147543691|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
73997914|NCT00923260|147543692|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||t-test, 2 sided|||||||0.52
73997915|NCT00923260|147543693|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||t-test, 2 sided|||||||0.59
73997916|NCT00923260|147543694|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||||||0.57
73997917|NCT00923260|147543695|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
73997918|NCT00923260|147543696|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
73997919|NCT00923260|147543697|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||t-test, 2 sided|||||||0.56
73997920|NCT00660543|147543698|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.||||||.003
73997921|NCT00660543|147543698|SUPERIORITY_OR_OTHER|||||||0.008|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.||||||.008
73997922|NCT01262677|147543700|SUPERIORITY||Mean Difference|-0.99||||0.9076|TWO_SIDED|95.0|-16.28|17.11||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.||17.11|-16.28|0.9076
73997923|NCT01262677|147543700|SUPERIORITY||Mean Difference|-13.05||||0.0907|TWO_SIDED|95.0|-26.07|2.25||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.||2.25|-26.07|0.0907
74036301|NCT04095286|147625055|OTHER||Ratio of adjusted geometric mean|1.05|||||TWO_SIDED|90.0|1.02|1.08|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.08|1.02|
74036302|NCT04095286|147625055|OTHER||Ratio of adjusted geometric mean|1.04|||||TWO_SIDED|90.0|1.01|1.07|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.07|1.01|
74036303|NCT02115113|147625075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.24|STANDARD_ERROR_OF_MEAN|5.01||0.3013|TWO_SIDED|95.0|-4.86|15.34|||ANOVA|||||15.34|-4.86|0.3013
74036304|NCT03736629|147625082|SUPERIORITY||Mean Difference (Net)|-0.67|STANDARD_ERROR_OF_MEAN|1.72||0.72|TWO_SIDED|95.0|-6.14|4.81|||t-test, 2 sided|||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.||4.81|-6.14|0.72
74036305|NCT03736629|147625083|SUPERIORITY||Mean Difference (Net)|-5.67||||0.59|TWO_SIDED|95.0|-35.98|24.65|||t-test, 2 sided||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.|||24.65|-35.98|0.59
74036306|NCT03736629|147625086|SUPERIORITY|||||||1|||||||Fisher Exact|||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.||||1.0
74036307|NCT02622724|147625092|SUPERIORITY|||||||0.8219|||||||Van Elteren hypothesis test|||A non-parametric analysis has been used as the data distribution was skewed. This involved a generalised Wilcoxon rank sum-based stratification test which assigns ranks within strata and compares two treatments within strata (Van Elteren hypothesis test).||||0.8219
74036308|NCT02622724|147625099|SUPERIORITY|||||||0.4678|||||||Van Elteren p-values|||Van Elteren hypothesis test was used as the distribution was non-normal and negatively skewed by patients who are assigned scores of zero in the event of death.||||0.4678
74036309|NCT02622724|147625104|SUPERIORITY||||||<|0.05|||||||ANCOVA|Analysis of covariance (ANCOVA) model using Type III sums of squares with Treatment, Severity, and Country fixed effect factors, Baseline as covariate||||||<0.05
74036310|NCT02622724|147625107|OTHER||Least Squares Mean|31.1|||>|0.05|TWO_SIDED|95.0|-37.7|99.9|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95% Confidence Intervals) for the overall treatment difference for maximum distance walked on Day 180.||99.9|-37.7|>0.05
73997924|NCT01262677|147543701|SUPERIORITY|||||||0.752||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.||||0.752
73876931|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|15.6||||0.465|TWO_SIDED|95.0|-19.5|50.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||50.7|-19.5|0.465
73997925|NCT01262677|147543701|SUPERIORITY|||||||0.125||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.||||0.125
74090472|NCT03864042|147734374|OTHER||Geometric LS Mean Ratio|1.48|||||TWO_SIDED|90.0|1.2|1.83|||||Day 14 / Day -7|||1.83|1.20|
74090473|NCT03864042|147734375|OTHER||Geometric LS Mean Ratio|1.45|||||TWO_SIDED|90.0|0.902|2.32|||||Day 1 / Day -7|||2.32|0.902|
74090474|NCT03864042|147734375|OTHER||Geometric LS Mean Ratio|1.18|||||TWO_SIDED|90.0|0.72|1.93|||||Day 14 / Day -7|||1.93|0.720|
74090475|NCT03864042|147734376|OTHER||Geometric LS Mean Ratio|1.47|||||TWO_SIDED|90.0|0.915|2.36|||||Day 1 / Day -7|||2.36|0.915|
74090476|NCT03864042|147734376|OTHER||Geometric LS Mean Ratio|0.851|||||TWO_SIDED|90.0|0.519|1.39|||||Day 14 / Day -7|||1.39|0.519|
74090477|NCT03864042|147734377|OTHER||Geometric LS Mean Ratio|1.2|||||TWO_SIDED|90.0|0.775|1.87|||||Day 1 / Day -7|||1.87|0.775|
74090478|NCT03864042|147734377|OTHER||Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.593|1.49|||||Day 14 / Day -7|||1.49|0.593|
74090479|NCT03864042|147734378|OTHER||Geometric LS Mean Ratio|1.18|||||TWO_SIDED|90.0|0.83|1.67|||||Day 1 / Day -7|||1.67|0.830|
74090480|NCT03864042|147734378|OTHER||Geometric LS Mean Ratio|0.979|||||TWO_SIDED|90.0|0.68|1.41|||||Day 14 / Day -7|||1.41|0.680|
73876932|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|3.9||||0.745|TWO_SIDED|95.0|-19.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||27.0|-19.3|0.745
73997926|NCT01262677|147543702|SUPERIORITY||LS Mean Difference|-9.3||||0.5404|TWO_SIDED|95.0|-39.16|20.56||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.||20.56|-39.16|0.5404
73997927|NCT01262677|147543702|SUPERIORITY||LS Mean Difference|-25.84||||0.0786|TWO_SIDED|95.0|-54.64|2.97||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.||2.97|-54.64|0.0786
73997928|NCT01262677|147543703|SUPERIORITY||LS Mean Difference|-0.11||||0.6073|TWO_SIDED|95.0|-0.53|0.31||Statistical testing was done at alpha = 0.05 level, two-sided.|Generalized linear model (GLM)|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.||0.31|-0.53|0.6073
73997929|NCT01262677|147543703|SUPERIORITY||LS Mean Difference|-0.16||||0.4109|TWO_SIDED|95.0|-0.53|0.22||Statistical testing was done at alpha = 0.05 level, two-sided.|GLM|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.||0.22|-0.53|0.4109
74090481|NCT03864042|147734379|OTHER||Geometric LS Mean Ratio|0.798|||||TWO_SIDED|90.0|0.585|1.09|||||Day 21 / Day 14|||1.09|0.585|
74090482|NCT03864042|147734380|OTHER||Geometric LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.935|1.11|||||Day 21 / Day 14|||1.11|0.935|
74090483|NCT03864042|147734381|OTHER||Geometric LS Mean Ratio|0.762|||||TWO_SIDED|90.0|0.613|0.945|||||Day 21 / Day 14|||0.945|0.613|
74090484|NCT03864042|147734382|OTHER||Geometric LS Mean Ratio|1.06|||||TWO_SIDED|90.0|0.929|1.22|||||Day 21 / Day 14|||1.22|0.929|
74090485|NCT02220725|147734500|SUPERIORITY||Hodges-Lehman estimate of shift|-70.14|||<|0.0001|TWO_SIDED|95.0|-85.43|-65.91|||2-sided test exact Wilcoxon rank-sum tes|||||-65.91|-85.43|<0.0001
74090486|NCT02220725|147734500|SUPERIORITY||Hodges-Lehman estimate of shift|-51.87|||<|0.0001|TWO_SIDED|95.0|-57.95|-47.03|||2-sided test exact Wilcoxon rank-sum tes|||||-47.03|-57.95|<0.0001
74090487|NCT02220725|147734501|SUPERIORITY||Hodges-Lehman estimate of shift|-74.45|||<|0.0001|TWO_SIDED|95.0|-78.92|-64.45|||2-sided test exact Wilcoxon rank-sum tes|||||-64.45|-78.92|<0.0001
74090488|NCT02220725|147734503|SUPERIORITY||Hodges-Lehmann Estimate of Shift|-18.0|||<|0.0001|TWO_SIDED|95.0|-23.05|-12.73|||2-sided test exact Wilcoxon rank-sum tes|||||-12.73|-23.05|<0.0001
74090489|NCT02220725|147734504|SUPERIORITY||Hodges-Lehman estimate of shift|1142.66|||<|0.0001|TWO_SIDED|95.0|1006.1|1281.4|||2-sided test exact Wilcoxon rank-sum tes|||||1281.40|1006.10|<0.0001
74090490|NCT02220725|147734504|SUPERIORITY||Hodges-Lehman estimate of shift|1205.05|||<|0.0001|TWO_SIDED|95.0|1034.17|1400.79|||2-sided test exact Wilcoxon rank-sum tes|||||1400.79|1034.17|<0.0001
74090491|NCT02340221|147734508|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0037|TWO_SIDED|95.0|0.56|0.89|||Log Rank|||||0.89|0.56|0.0037
74090492|NCT02340221|147734509|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0008|TWO_SIDED|95.0|0.58|0.87|||Log Rank|||||0.87|0.58|0.0008
74090493|NCT02340221|147734510|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0002|TWO_SIDED|95.0|1.6|5.4|||Cochran-Mantel-Haenszel|||||5.4|1.6|0.0002
74090494|NCT02340221|147734511|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|1.7|5.4|||Cochran-Mantel-Haenszel|||||5.4|1.7|<0.0001
74090495|NCT02340221|147734512|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4151|TWO_SIDED|95.0|0.58|1.25|||Log Rank|||||1.25|0.58|0.4151
74090496|NCT02340221|147734513|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9974|TWO_SIDED|95.0|0.75|1.33|||Log Rank|||||1.33|0.75|0.9974
74090497|NCT02340221|147734514|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.2|2.9||||||||2.9|1.2|
74090498|NCT02340221|147734515|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.2|3.0||||||||3.0|1.2|
74090499|NCT02340221|147734516|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.6708|TWO_SIDED|95.0|0.23|2.59|||Log Rank|||||2.59|0.23|0.6708
74090500|NCT02340221|147734517|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8286|TWO_SIDED|95.0|0.51|2.35|||Log Rank|||||2.35|0.51|0.8286
74090501|NCT02340221|147734518|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0023|TWO_SIDED|95.0|0.51|0.86|||Log Rank|||||0.86|0.51|0.0023
74090502|NCT02340221|147734519|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0095|TWO_SIDED|95.0|0.56|0.92|||Log Rank|||||0.92|0.56|0.0095
73876933|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-8.3||||0.512|TWO_SIDED|95.0|-32.6|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||16.1|-32.6|0.512
73876934|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|22.5||||0.281|TWO_SIDED|95.0|-12.2|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||57.2|-12.2|0.281
73997930|NCT01262677|147543704|SUPERIORITY||LS Mean Difference|-1.38||||0.8268|TWO_SIDED|95.0|-12.97|11.75||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||11.75|-12.97|0.8268
73997931|NCT01262677|147543704|SUPERIORITY||LS Mean Difference|0.75||||0.9024|TWO_SIDED|95.0|-10.69|13.66||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||13.66|-10.69|0.9024
73997932|NCT01262677|147543705|SUPERIORITY|||||||0.67||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.||||0.670
73997933|NCT01262677|147543705|SUPERIORITY|||||||0.927||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.||||0.927
73997934|NCT01262677|147543706|SUPERIORITY||LS Mean Difference|2.28||||0.8034|TWO_SIDED|95.0|-14.37|22.15||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||22.15|-14.37|0.8034
73997935|NCT01262677|147543706|SUPERIORITY||LS Mean Difference|-10.78||||0.1905|TWO_SIDED|95.0|-24.81|5.87||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.87|-24.81|0.1905
73997936|NCT01262677|147543707|SUPERIORITY||LS Mean Difference|-0.3||||0.465|TWO_SIDED|95.0|-1.1|0.5||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.5|-1.1|0.4650
73997937|NCT01262677|147543707|SUPERIORITY||LS Mean Difference|0.0||||0.9692|TWO_SIDED|95.0|-0.8|0.8||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.8|-0.8|0.9692
73997938|NCT01262677|147543708|SUPERIORITY||LS Mean Difference|-0.5||||0.2693|TWO_SIDED|95.0|-1.3|0.4||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.4|-1.3|0.2693
74008584|NCT01368042|147567175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|20.9||0.38|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.38
74090503|NCT00103402|147734526|SUPERIORITY|The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.|Risk Difference (RD)|0.1||||0.99|TWO_SIDED|95.0|-11.2|11.0|||Mantel Haenszel|The exact conditional test version of the Mantel-Haenszel test was used to control for clustering by clinical center.||Sample-size calculations were based on a 2-sided alpha of 0.05 with 80% power to detect a difference of 20 between response rates (40% placebo and 60% alfuzosin) for the Fisher's exact test. We calculated that a total sample of 270 participants would be required (135 per study group). This proposed sample size included a 20% increase to adjust for clustering within clinical sites and a 5% increase for interim monitoring.||11.0|-11.2|0.99
74090504|NCT00103402|147734527|SUPERIORITY|The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.|Risk Difference (RD)|1.8||||0.9|TWO_SIDED|95.0|-9.0|2.5|||Mantel Haenszel|||Marked or moderate improvement at 12 weeks Absolute Difference in Rates % (95% CI)||2.5|-9.0|0.90
74090505|NCT00103402|147734528|SUPERIORITY||Mean Difference (Net)|-0.5||||0.7|TWO_SIDED|95.0|-2.7|1.5|||t-test, 2 sided|||Total score (0-43) change from baseline||1.5|-2.7|0.70
73876935|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-8.1||||0.486|TWO_SIDED|95.0|-30.8|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||14.6|-30.8|0.486
73876936|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-15.8||||0.212|TWO_SIDED|95.0|-39.5|8.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||8.0|-39.5|0.212
73997939|NCT01262677|147543708|SUPERIORITY||LS Mean Difference|-0.5||||0.1893|TWO_SIDED|95.0|-1.4|0.3||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.3|-1.4|0.1893
73997940|NCT01262677|147543709|SUPERIORITY||LS Mean Difference|-0.8||||0.7347|TWO_SIDED|95.0|-5.2|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.6|-5.2|0.7347
73997941|NCT01262677|147543709|SUPERIORITY||LS Mean Difference|0.3||||0.8971|TWO_SIDED|95.0|-4.0|4.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.6|-4.0|0.8971
73997942|NCT01262677|147543710|SUPERIORITY||LS Mean Difference|-2.7||||0.3972|TWO_SIDED|95.0|-9.1|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.6|-9.1|0.3972
73997943|NCT01262677|147543710|SUPERIORITY||LS Mean Difference|6.7||||0.0319|TWO_SIDED|95.0|0.6|12.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||12.9|0.6|0.0319
73997944|NCT01262677|147543711|SUPERIORITY||LS Mean Difference|0.8||||0.7708|TWO_SIDED|95.0|-4.4|5.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.9|-4.4|0.7708
73997945|NCT01262677|147543711|SUPERIORITY||LS Mean Difference|2.4||||0.356|TWO_SIDED|95.0|-2.7|7.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||7.4|-2.7|0.3560
73997946|NCT01262677|147543712|SUPERIORITY||LS Mean Difference|0.2||||0.1129|TWO_SIDED|95.0|-0.1|0.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||0.5|-0.1|0.1129
73997947|NCT01262677|147543712|SUPERIORITY||LS Mean Difference|0.0||||0.9388|TWO_SIDED|95.0|-0.3|0.3||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||0.3|-0.3|0.9388
73997948|NCT01262677|147543713|SUPERIORITY||LS Mean Difference|-0.4||||0.9053|TWO_SIDED|95.0|-7.5|6.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||6.6|-7.5|0.9053
74090506|NCT00103402|147734528|SUPERIORITY||Mean Difference (Net)|-0.3||||0.64|TWO_SIDED|95.0|-1.4|0.8|||t-test, 2 sided|||Pain score (0-21) change from baseline||0.8|-1.4|0.64
74090507|NCT00103402|147734528|SUPERIORITY||Mean Difference (Net)|-0.2||||0.62|TWO_SIDED|95.0|-0.8|0.4|||t-test, 2 sided|||Urinary score (0-10) change from baseline||0.4|-0.8|0.62
73876937|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|11.9||||0.697|TWO_SIDED|95.0|-22.3|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||46.0|-22.3|0.697
73997949|NCT01262677|147543713|SUPERIORITY||LS Mean Difference|-1.6||||0.6371|TWO_SIDED|95.0|-8.5|5.2||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.2|-8.5|0.6371
74008585|NCT01368042|147567176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_DEVIATION|32.0|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
73997950|NCT01262677|147543714|SUPERIORITY||LS Mean Difference|-6.4||||0.0119|TWO_SIDED|95.0|-11.4|-1.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||-1.4|-11.4|0.0119
73997951|NCT01262677|147543714|SUPERIORITY||LS Mean Difference|0.0||||0.9909|TWO_SIDED|95.0|-4.9|4.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.8|-4.9|0.9909
73997952|NCT01262677|147543715|SUPERIORITY||LS Mean Difference|-1.1||||0.5903|TWO_SIDED|95.0|-5.0|2.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||2.8|-5.0|0.5903
73997953|NCT01262677|147543715|SUPERIORITY||LS Mean Difference|0.7||||0.7126|TWO_SIDED|95.0|-3.1|4.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.5|-3.1|0.7126
73997954|NCT01262677|147543716|SUPERIORITY||LS Mean Difference|-2.1||||0.2431|TWO_SIDED|95.0|-5.8|1.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||1.5|-5.8|0.2431
73997955|NCT01262677|147543716|SUPERIORITY||LS Mean Difference|0.3||||0.8654|TWO_SIDED|95.0|-3.2|3.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.8|-3.2|0.8654
73997956|NCT01262677|147543717|SUPERIORITY||Odds Ratio (OR)|1.36||||0.3241|TWO_SIDED|95.0|0.74|2.5||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.||2.50|0.74|0.3241
73997957|NCT01262677|147543717|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8932|TWO_SIDED|95.0|0.54|1.71||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.||1.71|0.54|0.8932
73997958|NCT02055781|147543740|SUPERIORITY|||||||0.0011|||||||Fisher Exact|||BAT arm compared to pooled pacritinib arms (QD + BID - ITT Efficacy)||||0.0011
73997959|NCT02055781|147543740|SUPERIORITY|||||||0.0173|||||||Fisher Exact|||||||0.0173
73997960|NCT02055781|147543740|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||||||0.0007
73997961|NCT02055781|147543741|SUPERIORITY|||||||0.0791|||||||Fisher Exact|||BAT arm compared to pooled pacritinib arms (QD + BID - ITT Efficacy)||||0.0791
73997962|NCT02055781|147543741|SUPERIORITY|||||||0.6524|||||||Fisher Exact|||||||0.6524
73997963|NCT02055781|147543741|SUPERIORITY|||||||0.0106|||||||Fisher Exact|||||||0.0106
73997964|NCT00201643|147543742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.1162||0.002|TWO_SIDED|95.0|0.27|0.75||Analysis were also conducted in all randomized women with a known outcome \& in randomized treatment group(modified intent to treat). Analysis of the primary outcome used a repeated measures approach where each baby was considered a repeated measure|Fisher Exact|||Our Hypothesis was that administration of a rescue ACS would show a 40% reduction in incidence of composite neonatal morbity in patients delivering \< 34 weeks. Sample size estimates based on composite morbidity of 28%. Each arm required 217 subjects to have 80% power to detect a 40% reduction to 16.8%(2-tailed,alpha =0.05)using comparison for proportions/groups(Fisher exact test) OR,95% CI \& P values were determined using a repeated measure model where each twin is considered a repeat measure.||0.75|0.27|0.002
73997965|NCT03446781|147543776|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.002
73997966|NCT03446781|147543777|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73997967|NCT03446781|147543778|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73997968|NCT03446781|147543779|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73997969|NCT03446781|147543780|SUPERIORITY|||||||0.033|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.033
73997970|NCT03446781|147543781|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73997971|NCT03446781|147543782|SUPERIORITY||||||<|0.001|||||||ANCOVA|With factors of treatment group and analysis center adjusted for baseline values in the model||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73997972|NCT03446781|147543783|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73997973|NCT03446781|147543784|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
73997974|NCT04410523|147543797|SUPERIORITY||Least Squares mean|0.122|STANDARD_ERROR_OF_MEAN|0.0541||0.025|TWO_SIDED|95.0|0.016|0.229|||MMRM||Treatment difference (CSJ117-placebo)|||0.229|0.016|0.025
73997975|NCT04410523|147543797|SUPERIORITY||Least Squares mean|0.058|STANDARD_ERROR_OF_MEAN|0.0542||0.286|TWO_SIDED|95.0|-0.049|0.165|||MMRM||Treatment difference (CCSJ117-placebo)|||0.165|-0.049|0.286
73997976|NCT04410523|147543797|SUPERIORITY||Least Squares mean|0.065|STANDARD_ERROR_OF_MEAN|0.0521||0.212|TWO_SIDED|95.0|-0.037|0.168|||MMRM||Treatment difference (CCSJ117-placebo)|||0.168|-0.037|0.212
73997977|NCT04410523|147543797|SUPERIORITY||Least Squares mean|0.009|STANDARD_ERROR_OF_MEAN|0.043||0.831|TWO_SIDED|95.0|-0.076|0.094|||MMRM||Treatment difference (CCSJ117-placebo)|||0.094|-0.076|0.831
73997978|NCT04410523|147543797|SUPERIORITY||Least Squares mean|-0.008|STANDARD_ERROR_OF_MEAN|0.0434||0.852|TWO_SIDED|95.0|-0.094|0.077|||MMRM||Treatment difference (CCSJ117-placebo)|||0.077|-0.094|0.852
73997979|NCT04410523|147543798|SUPERIORITY||Least Squares mean|-1.568|STANDARD_ERROR_OF_MEAN|2.363||0.508|TWO_SIDED|95.0|-6.219|3.083|||MMRM||Treatment difference (CSJ117-placebo)|||3.083|-6.219|0.508
73997980|NCT04410523|147543798|SUPERIORITY||Least Squares mean|-3.998|STANDARD_ERROR_OF_MEAN|2.384||0.095|TWO_SIDED|95.0|-8.691|0.695|||MMRM||Treatment difference (CCSJ117-placebo)|||0.695|-8.691|0.095
74036311|NCT02622724|147625121|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL -1ra - changes in levels from baseline to Day 14||||>0.05
74036312|NCT02622724|147625121|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL- 6 - changes in levels from baseline to Day 14||||>0.05
74036313|NCT02622724|147625121|OTHER||LS Means difference|0.0|||<|0.05|ONE_SIDED|95.0|||||ANCOVA|ANCOVA estimates (LS means and a 95% CI for the treatment difference) were presented for all numeric biomarker variables.||FGF basic - changes in levels from baseline to Day 14||||<0.05
74036314|NCT02622724|147625121|OTHER||LS Means difference|0.0|||<|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IP-10 - changes in levels from baseline to Day 14.||||<0.05
74036315|NCT02622724|147625121|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||TNF-α - changes in levels from baseline to Day 14||||>0.05
74036316|NCT02622724|147625122|OTHER||||||<|0.007||||||The p-value is not adjusted for multiple comparisons.|Chi-squared|||||||<0.007
74036317|NCT02622724|147625125|OTHER||Least Squares Mean|28.0|||>|0.05|TWO_SIDED|95.0|-54.0|110.1|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95 % Confidence Intervals) for the overall treatment difference for maximun distance walked on Day 360.||110.1|-54|>0.05
74036318|NCT00487084|147625128|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Log Rank|||A sample of 56 was estimated to have an 80% power to detect a 30% difference in the proportion of subjects with continuing analgesia in the MCS versus the SCM groups when 50% of the subjects in the SCM had requested supplemental analgesia. 28 subjects was added to compare the influence of time of morphine and 2-chloroprocaine administration to lidocaine-morphine analgesia. The primary outcome was compared using Kaplan-Meier survival analysis and the log-rank test.||||0.006
74036319|NCT00487084|147625128|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Log Rank|||||||0.83
74036320|NCT00487084|147625128|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Log Rank|||||||0.009
74036321|NCT00487084|147625129|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||||||<0.05
74036322|NCT00487084|147625129|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||||||<0.05
74036323|NCT00487084|147625130|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
74090508|NCT00103402|147734528|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|||Quality of life score (0-12) change from baseline||0.4|-0.4|.99
74090509|NCT00103402|147734529|SUPERIORITY||Mean Difference (Net)|-0.3||||0.45|TWO_SIDED|95.0|-1.8|1.2|||t-test, 2 sided|||McGill Total Score||1.2|-1.8|0.45
73997981|NCT04410523|147543798|SUPERIORITY||Least Squares mean|-2.889|STANDARD_ERROR_OF_MEAN|2.2943||0.209|TWO_SIDED|95.0|-7.405|1.627|||MMRM||Treatment difference (CCSJ117-placebo)|||1.627|-7.405|0.209
74036324|NCT00487084|147625130|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
74036325|NCT00487084|147625131|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared, Corrected|||||||0.20
74036326|NCT00333619|147625143|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||ANOVA|||||||0.10
74036327|NCT00333619|147625144|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
74036328|NCT03209440|147625145|SUPERIORITY||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|0.73||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
74036329|NCT03209440|147625145|SUPERIORITY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|0.74||0.005|TWO_SIDED||||||Regression, Linear|||||||0.005
74036330|NCT03209440|147625146|SUPERIORITY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|0.49||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
74036331|NCT03209440|147625146|SUPERIORITY||Median Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.5||0.12|TWO_SIDED||||||Regression, Linear|||||||0.12
74036332|NCT03209440|147625147|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.72||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
74036333|NCT03209440|147625147|SUPERIORITY||Mean Difference (Net)|0.91|STANDARD_ERROR_OF_MEAN|0.73||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
74036334|NCT03209440|147625148|SUPERIORITY||Odds Ratio, log|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.11|TWO_SIDED||||||Regression, Logistic|||||||0.11
74036335|NCT03209440|147625148|SUPERIORITY||Odds Ratio, log|0.96|STANDARD_ERROR_OF_MEAN|0.64||0.14|TWO_SIDED||||||Regression, Logistic|||||||0.14
74036336|NCT03209440|147625149|SUPERIORITY||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED||||||Regression, Linear|"The outcome variable was scored as 1= prolong life; treat everything to 4 = provide comfort care only."||||||0.05
74036337|NCT03209440|147625149|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.46|TWO_SIDED||||||Regression, Linear|"The outcome variable was scored as 1= prolong life; treat everything to 4 = provide comfort care only."||||||0.46
74036338|NCT00485589|147625169|NON_INFERIORITY|Pre-specified analysis||||||0.001|||||||Van Elteren's test|||||||0.001
74036339|NCT00485589|147625169|NON_INFERIORITY|Pre-specified analysis||||||0.0033|||||||Van Elteren's test|||||||0.0033
74090510|NCT00103402|147734529|SUPERIORITY||Mean Difference (Net)|-0.2||||0.47|TWO_SIDED|95.0|-1.4|1.0|||t-test, 2 sided|||McGill Sensory Score||1.0|-1.4|0.47
74036340|NCT03377244|147625182|SUPERIORITY|||||||0.1013||||||The p-value above reflects results of between-arms analysis of percent change in weight from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.1013
73997982|NCT04410523|147543798|SUPERIORITY||Least Squares mean|-0.287|STANDARD_ERROR_OF_MEAN|1.8718||0.878|TWO_SIDED|95.0|-3.971|3.398|||MMRM||Treatment difference (CCSJ117-placebo)|||3.398|-3.971|0.878
73997983|NCT04410523|147543798|SUPERIORITY||Least Squares mean|1.093|STANDARD_ERROR_OF_MEAN|1.8652||0.558|TWO_SIDED|95.0|-2.578|4.765|||MMRM||Treatment difference (CCSJ117-placebo)|||4.765|-2.578|0.558
73997984|NCT04410523|147543801|SUPERIORITY||Least Squares mean|-0.042|STANDARD_ERROR_OF_MEAN|0.1493||0.78|TWO_SIDED|95.0|-0.336|0.252|||MMRM||Treatment difference (CSJ117-placebo)|||0.252|-0.336|0.780
74036341|NCT03377244|147625183|SUPERIORITY|||||||0.495||||||The p-value above reflects results of between-arms analysis of change in mean HbA1c from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment.||||||0.4950
73997985|NCT04410523|147543801|SUPERIORITY||Least Squares mean|-0.42|STANDARD_ERROR_OF_MEAN|0.1489||0.005|TWO_SIDED|95.0|-0.713|-0.127|||MMRM||Treatment difference (CCSJ117-placebo)|||-0.127|-0.713|0.005
74036342|NCT03377244|147625184|SUPERIORITY|||||||0.7416||||||The p-value above reflects results of between-arms analysis of change in systolic blood pressure from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.7416
74036343|NCT03377244|147625185|SUPERIORITY|||||||0.0702||||||The p-value above reflects results of between-arms analysis of change in diastolic blood pressure from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0702
74036344|NCT03377244|147625186|SUPERIORITY|||||||0.007||||||The p-value above reflects results of between-arms analysis of change in eating habits self-efficacy scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0070
74036345|NCT03377244|147625187|SUPERIORITY|||||||0.0009||||||The p-value above reflects results of between-arms analysis of change in physical activity self-efficacy scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0009
74036346|NCT03377244|147625188|SUPERIORITY|||||||0.374||||||The p-value above reflects results of between-arms analysis for the probability of participants to engage in sufficient physical activity at 6 months post-intervention.|Regression, Logistic|Model adjusted for age, sex, education, marital status, employment status, and baseline physical activity.||||||0.3740
74090511|NCT00103402|147734529|SUPERIORITY||Mean Difference (Net)|-0.1||||0.89|TWO_SIDED|95.0|-0.6|0.4|||t-test, 2 sided|||McGill Affective Score||0.4|-0.6|0.89
73997986|NCT04410523|147543801|SUPERIORITY||Least Squares mean|-0.289|STANDARD_ERROR_OF_MEAN|0.1446||0.047|TWO_SIDED|95.0|-0.573|0.004|||MMRM||Treatment difference (CCSJ117-placebo)|||0.004|-0.573|0.047
73997987|NCT04410523|147543801|SUPERIORITY||Least Squares mean|-0.017|STANDARD_ERROR_OF_MEAN|0.1182||0.887|TWO_SIDED|95.0|-0.249|0.216|||MMRM||Treatment difference (CCSJ117-placebo)|||0.216|-0.249|0.887
73997988|NCT04410523|147543801|SUPERIORITY||Least Squares mean|-0.115|STANDARD_ERROR_OF_MEAN|0.1184||0.333|TWO_SIDED|95.0|-0.348|0.118|||MMRM||Treatment difference (CCSJ117-placebo)|||0.118|-0.348|0.333
74036347|NCT03377244|147625189|SUPERIORITY|||||||0.9556||||||The p-value above reflects results of between-arms analysis of change in participants' sugar-sweetened beverage consumption per day from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.9556
74036348|NCT03377244|147625190|SUPERIORITY|||||||0.1726||||||The p-value above reflects results of between-arms analysis of change in participants' fruit and vegetable consumption scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.1726
74036349|NCT03377244|147625191|SUPERIORITY|||||||0.0478||||||The p-value above reflects results of between-arms analysis of change in participants' family support scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0478
73997989|NCT04410523|147543802|SUPERIORITY||Least Squares mean|-0.097|STANDARD_ERROR_OF_MEAN|0.1485||0.515|TWO_SIDED|95.0|-0.389|0.195|||MMRM||Treatment difference (CSJ117-placebo)|||0.195|-0.389|0.515
74036350|NCT00174785|147625193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.69|0.84||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason or death for the dronedarone group compared with the placebo group.|||0.84|0.69|<0.0001
74036351|NCT00174785|147625194|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.18||95.0|0.66|1.08||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the dronedarone group compared with the placebo group.|||1.08|0.66|0.18
74036352|NCT00174785|147625195|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||<|0.0001||95.0|0.67|0.82||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason for the dronedarone group compared with the placebo group.|||0.82|0.67|<0.0001
74036353|NCT00174785|147625196|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.025||95.0|0.51|0.96||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of cardiovascular death for the dronedarone group compared with the placebo group.|||0.96|0.51|0.025
73997990|NCT04410523|147543802|SUPERIORITY||Least Squares mean|0.218|STANDARD_ERROR_OF_MEAN|0.1484||0.143|TWO_SIDED|95.0|-0.074|0.51|||MMRM||Treatment difference (CCSJ117-placebo)|||0.510|-0.074|0.143
73997991|NCT04410523|147543802|SUPERIORITY||Least Squares mean|0.078|STANDARD_ERROR_OF_MEAN|0.145||0.59|TWO_SIDED|95.0|-0.207|0.364|||MMRM||Treatment difference (CCSJ117-placebo)|||0.364|-0.207|0.590
73997992|NCT04410523|147543802|SUPERIORITY||Least Squares mean|0.033|STANDARD_ERROR_OF_MEAN|0.118||0.778|TWO_SIDED|95.0|-0.199|0.265|||MMRM||Treatment difference (CCSJ117-placebo)|||0.265|-0.199|0.778
73997993|NCT04410523|147543802|SUPERIORITY||Least Squares mean|0.073|STANDARD_ERROR_OF_MEAN|0.118||0.539|TWO_SIDED|95.0|-0.16|0.305|||MMRM||Treatment difference (CCSJ117-placebo)|||0.305|-0.160|0.539
73997994|NCT03651622|147543836|SUPERIORITY|||||||0.98|||||||ANOVA|||||||0.98
73997995|NCT03651622|147543837|SUPERIORITY|||||||0.85|||||||ANOVA|||||||0.85
73997996|NCT03651622|147543838|SUPERIORITY|||||||0.4|||||||ANOVA|||||||0.40
73997997|NCT03651622|147543839|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.02
73997998|NCT03651622|147543840|SUPERIORITY|||||||0.38|||||||ANOVA|||||||0.38
73997999|NCT03651622|147543841|SUPERIORITY|||||||0.18|||||||ANOVA|||||||0.18
73998000|NCT03651622|147543842|SUPERIORITY|||||||0.79|||||||ANOVA|||||||0.79
73998001|NCT03651622|147543843|SUPERIORITY|||||||0.39|||||||ANOVA|||The proposed sample size of n=72 was sufficient to ensure 60% power to detect a moderate effect size (Cohen h=0.68) and 80% to detect a large effect size (Cohen h=0.85) at a significance level of 0.10 for comparing difference in change among the 3 diets. By design, our primary goal for this pilot work is to inform the final efficacy design of a fully powered SMART, and the pilot SMART was therefore not designed to be fully powered for all analyses.||||0.39
73998002|NCT03651622|147543844|SUPERIORITY|||||||0.75|||||||ANOVA|||||||0.75
73998003|NCT03651622|147543845|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
73998004|NCT03651622|147543846|SUPERIORITY|||||||0.96|||||||ANOVA|||||||0.96
73998005|NCT03651622|147543847|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.34
73998006|NCT03651622|147543848|SUPERIORITY|||||||0.58|||||||ANOVA|||||||0.58
73998007|NCT03651622|147543849|SUPERIORITY|||||||0.95|||||||ANOVA|||||||0.95
73998008|NCT03651622|147543850|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
73998009|NCT00127205|147543889|OTHER|||||||0.49|||||||Log Rank|||||||0.49
73998010|NCT00127205|147543889|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.24|TWO_SIDED|95.0|0.94|1.26|||Regression, Cox|||||1.26|0.94|0.24
73998011|NCT00127205|147543889|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.5|TWO_SIDED|95.0|0.9|1.24|||Regression, Cox|||||1.24|0.90|0.50
73998012|NCT00127205|147543890|OTHER|||||||0.5|||||||Log Rank|||||||0.50
73998013|NCT00127205|147543891|OTHER|||||||0.93|||||||Log Rank|||Statistical analysis for recurrence to bone||||0.93
73998014|NCT03582943|147543896|SUPERIORITY|A priori power analyses was designed to detect at least a 3 second difference in change in balance scores between groups.|Mean Difference (Net)|0.74||||0.984|TWO_SIDED|||||Test of differences between groups.|Mixed Models Analysis|||||||0.984
73998015|NCT03582943|147543896|SUPERIORITY||Mean Difference (Net)|-0.023||||0.455|TWO_SIDED|||||Test of interaction between age and RLIC vs. sham|Mixed Models Analysis|||||||.455
73998016|NCT03582943|147543896|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.803|TWO_SIDED|||||Test of interaction between sex and RLIC vs. sham conditioning|Mixed Models Analysis|||||||0.803
74090512|NCT00103402|147734530|SUPERIORITY||Mean Difference (Net)|-0.5||||0.6|TWO_SIDED|95.0|-2.3|1.3|||t-test, 2 sided|||Physical component summary (0-100) change in scores||1.3|-2.3|0.60
74090513|NCT00103402|147734530|SUPERIORITY||Mean Difference (Net)|2.1||||0.16|TWO_SIDED|95.0|-0.4|4.6|||t-test, 2 sided|||Mental component summary (0-100) Absolute Difference between Groups (95% CI)||4.6|-0.4|0.16
74090514|NCT00103402|147734531|SUPERIORITY||Mean Difference (Net)|-1.1||||0.08|TWO_SIDED|95.0|-2.4|0.2|||t-test, 2 sided|||||0.2|-2.4|0.08
73998017|NCT03582943|147543896|SUPERIORITY||Mean Difference (Net)|0.25||||0.233|TWO_SIDED|||||Test of interaction between BMI and RLIC vs. sham conditioning|Mixed Models Analysis|||||||0.233
73998018|NCT03582943|147543896|SUPERIORITY|Test of interaction between presence of co-morbidities and RLIC vs. sham conditioning|Mean Difference (Net)|4.12||||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.29
73998019|NCT05126563|147543897|SUPERIORITY||LS Means|0.054|STANDARD_ERROR_OF_MEAN|0.738||0.9416|TWO_SIDED|95.0|-1.42|1.53|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Extreme fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.53|-1.42|0.9416
73998020|NCT05126563|147543898|SUPERIORITY||LS Means|-0.172|STANDARD_ERROR_OF_MEAN|0.685||0.8021|TWO_SIDED|95.0|-1.54|1.2|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.20|-1.54|0.8021
73998021|NCT05126563|147543899|SUPERIORITY||LS Means|0.399|STANDARD_ERROR_OF_MEAN|0.515||0.4417|TWO_SIDED|95.0|-0.63|1.43|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms. - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.43|-0.63|0.4417
73998022|NCT05126563|147543900|SUPERIORITY||Slope|0.542|STANDARD_ERROR_OF_MEAN|0.721||0.455|TWO_SIDED|95.0|-0.9|1.98|||ANCOVA|||The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.98|-0.90|0.4550
73998023|NCT05126563|147543901|SUPERIORITY||LS Means|-0.047|STANDARD_ERROR_OF_MEAN|0.466||0.92|TWO_SIDED|95.0|-0.98|0.89|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.89|-0.98|0.9200
74008586|NCT01368042|147567177|SUPERIORITY_OR_OTHER|||||||0.03|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Physical functioning scale||||0.03
73876938|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||19.9|-23.2|0.880
73998024|NCT05126563|147543902|SUPERIORITY||LS Means|-0.16|STANDARD_ERROR_OF_MEAN|0.36||0.6589|TWO_SIDED|95.0|-0.88|0.56|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.56|-0.88|0.6589
73998025|NCT05126563|147543903|SUPERIORITY||LS Means|0.162|STANDARD_ERROR_OF_MEAN|0.725||0.824|TWO_SIDED|95.0|-1.29|1.61|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms Extreme Fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.61|-1.29|0.8240
73998026|NCT05126563|147543904|SUPERIORITY||LS Means|-0.009|STANDARD_ERROR_OF_MEAN|0.686||0.9892|TWO_SIDED|95.0|-1.38|1.36|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain Fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.36|-1.38|0.9892
73998027|NCT05126563|147543905|SUPERIORITY||LS Means|0.439|STANDARD_ERROR_OF_MEAN|0.513||0.3952|TWO_SIDED|95.0|-0.59|1.47|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.47|-0.59|0.3952
73998028|NCT05126563|147543906|SUPERIORITY||LS Means|0.535|STANDARD_ERROR_OF_MEAN|0.704||0.4504|TWO_SIDED|95.0|-0.87|1.94|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep Disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.94|-0.87|0.4504
73998029|NCT05126563|147543907|SUPERIORITY||LS Means|-0.161|STANDARD_ERROR_OF_MEAN|0.469||0.7318|TWO_SIDED|95.0|-1.1|0.78|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.78|-1.10|0.7318
73998030|NCT05126563|147543908|SUPERIORITY||LS Means|-0.215|STANDARD_ERROR_OF_MEAN|0.357||0.5485|TWO_SIDED|95.0|-0.93|0.5|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Smell scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.50|-0.93|0.5485
73998031|NCT05126563|147543939|SUPERIORITY||LS Means|-0.377|STANDARD_ERROR_OF_MEAN|0.407||0.3577|TWO_SIDED|95.0|-1.19|0.44|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at rest scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.44|-1.19|0.3577
73998032|NCT05126563|147543940|SUPERIORITY||LS Means|-0.203|STANDARD_ERROR_OF_MEAN|0.563||0.7196|TWO_SIDED|95.0|-1.33|0.92|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea during activity scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.92|-1.33|0.7196
73998033|NCT05126563|147543941|SUPERIORITY||LS Means|-0.306|STANDARD_ERROR_OF_MEAN|0.435||0.4847|TWO_SIDED|95.0|-1.18|0.56|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Cough scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.56|-1.18|0.4847
73998034|NCT05126563|147543942|SUPERIORITY||LS Means|0.619|STANDARD_ERROR_OF_MEAN|0.661||0.3535|TWO_SIDED|95.0|-0.71|1.94|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Body aches scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.94|-0.71|0.3535
73876939|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||11.2|-32.7|0.355
73998035|NCT05126563|147543943|SUPERIORITY||LS Means|0.472|STANDARD_ERROR_OF_MEAN|0.655||0.4746|TWO_SIDED|95.0|-0.84|1.78|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.78|-0.84|0.4746
74090515|NCT00103402|147734532|SUPERIORITY||Risk Difference (RD)|0.7||||0.94|TWO_SIDED|95.0|-2.6|4.0|||t-test, 2 sided|||||4.0|-2.6|0.94
74090516|NCT00103402|147734533|SUPERIORITY||Mean Difference (Net)|1.1||||0.06|TWO_SIDED|95.0|-0.3|2.5|||t-test, 2 sided|||||2.5|-0.3|0.06
74090517|NCT00986453|147734578|SUPERIORITY_OR_OTHER|||||||0.4697||95.0|||||t-test, 2 sided|||||||0.4697
74090518|NCT00986453|147734579|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||t-test, 2 sided|||||||0.1470
74090519|NCT00986453|147734580|SUPERIORITY_OR_OTHER|||||||0.0428||95.0|||||t-test, 2 sided|||||||0.0428
74090520|NCT00986453|147734581|SUPERIORITY_OR_OTHER|||||||0.0776||95.0|||||t-test, 2 sided|||||||0.0776
73876940|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||39.9|-23.7|0.678
73876941|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|1.7||||0.873|TWO_SIDED|95.0|-18.6|21.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||21.9|-18.6|0.873
73998036|NCT05126563|147543944|SUPERIORITY||LS Means|-1.433|STANDARD_ERROR_OF_MEAN|2.141||0.5059|TWO_SIDED|95.0|-5.72|2.85|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Subject's energy - Fatigue Assessment form scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||2.85|-5.72|0.5059
73998037|NCT05126563|147543945|SUPERIORITY||LS Means|-6.095|STANDARD_ERROR_OF_MEAN|4.99||0.2269|TWO_SIDED|95.0|-16.08|3.89|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups.|The null hypothesis is that the difference in change from baseline to Weeks 26 in Short Form 36 Health Survey Questionnaire (General Health) between treatment groups (HB-adMSCs - Placebo) is equal to zero.||3.89|-16.08|0.2269
73998038|NCT05126563|147543946|SUPERIORITY||LS Means|-0.122|STANDARD_ERROR_OF_MEAN|1.392||0.8735|TWO_SIDED|95.0|-2.91|2.66|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||2.66|-2.91|0.8735
73998039|NCT05126563|147543947|SUPERIORITY||LS Means|-3.424|STANDARD_ERROR_OF_MEAN|4.82||0.4802|TWO_SIDED|95.0|-13.07|6.22|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||6.22|-13.07|0.4802
73998040|NCT06612255|147543948|OTHER|Ratio (%) of adjusted geometric means with comparison presented as test (powder)/reference (tablet).|Fixed Effect Analysis|51.68|||||TWO_SIDED|90.0|45.71|58.43||||||Results obtained from mixed effects model of natural log transformed pharmacokinetic parameters including terms for regimen, period and sequence fitted as fixed effects and subject nested within sequence fitted as a random effect.||58.43|45.71|
73998041|NCT05032872|147543952|SUPERIORITY|||||||0.49||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time by condition interaction||||.49
73998042|NCT05032872|147543953|SUPERIORITY|||||||0.48||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.48
73998043|NCT05032872|147543954|SUPERIORITY|||||||0.04||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting satisfaction with contact quality||||.04
73998044|NCT05032872|147543954|SUPERIORITY|||||||0.44||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting dissatisfaction with contact quantity||||.44
73998045|NCT05032872|147543954|SUPERIORITY|||||||0.99||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting satisfaction with contact quantity||||.99
73998046|NCT05032872|147543954|SUPERIORITY|||||||0.87||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting knowing others' experience||||.87
73998047|NCT05032872|147543954|SUPERIORITY|||||||0.98||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting shared understanding||||.98
73998048|NCT05032872|147543954|SUPERIORITY|||||||0.76||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting relationship salience||||.76
73998049|NCT05032872|147543955|SUPERIORITY|||||||0.29||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.29
73998050|NCT05032872|147543956|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition predicting positive affect||||.51
73998051|NCT05032872|147543956|SUPERIORITY|||||||0.83||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition predicting negative affect||||.83
73998052|NCT05032872|147543957|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.51
73998053|NCT05032872|147543958|SUPERIORITY|||||||0.65||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.65
73998054|NCT05032872|147543959|SUPERIORITY|||||||0.01||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of distress||||.01
73998055|NCT05032872|147543959|SUPERIORITY|||||||0.75||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||time x condition interaction predicting caregiver overload||||.75
73998056|NCT05032872|147543959|SUPERIORITY|||||||0.59||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting relational deprivation||||.59
73998057|NCT05032872|147543959|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting job caregiving conflict||||.51
73998058|NCT05032872|147543959|SUPERIORITY|||||||0.25||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting role captivity||||.25
73998059|NCT05032872|147543959|SUPERIORITY|||||||0.34||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting sense of self||||.34
74090521|NCT00986453|147734582|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
73956680|NCT01018511|147449430|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41||0.028|TWO_SIDED|97.5|-1.22|0.64||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The non-inferiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.64|-1.22|0.028
73876942|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-0.1||||0.99|TWO_SIDED|95.0|-22.3|22.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||22.0|-22.3|0.990
73956681|NCT01018511|147449430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|TWO_SIDED|||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.||||0.048
73956682|NCT01018511|147449430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|TWO_SIDED|||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.||||0.483
73956683|NCT01018511|147449430|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-0.9||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of the FDC vs placebo on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||-0.9|-2.4|<0.001
73956684|NCT01018511|147449430|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.006|TWO_SIDED|95.0|-1.9|-0.3||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of the FDC vs. placebo on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||-0.3|-1.9|0.006
73956685|NCT01018511|147449430|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.039|TWO_SIDED|95.0|-1.6|0.0||No adjustments for multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in total IPSS. With a sample size of 274 participants per arm, the overall power to meet this outcome measure was 97% power for superiority vs placebo for total IPSS.||-0.0|-1.6|0.039
73956686|NCT01018511|147449431|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.64||0.025|TWO_SIDED|97.5|-2.9|0.0||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.0|-2.9|0.025
73998060|NCT05032872|147543959|SUPERIORITY|||||||0.75||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting personal gain||||.75
73998061|NCT05032872|147543959|SUPERIORITY|||||||0.99||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting caregiving competence||||.99
73998062|NCT05032872|147543959|SUPERIORITY|||||||0.61||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of situition||||.61
73998063|NCT05032872|147543959|SUPERIORITY|||||||0.92||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of meaning||||.92
73998064|NCT05032872|147543959|SUPERIORITY|||||||0.96||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting expressive support||||.96
73998065|NCT05032872|147543960|SUPERIORITY|||||||0.37||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.37
73998066|NCT05032872|147543961|SUPERIORITY|||||||0.89||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.89
73998067|NCT05032872|147543962|SUPERIORITY|||||||0.3||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.30
74090522|NCT01583218|147734583|SUPERIORITY||Relative Risk Reduction (RRR)|0.209||||0.038|TWO_SIDED|95.0|0.013|0.366|||Cochran-Mantel-Haenszel|||||0.366|0.013|0.038
74090523|NCT01583218|147734584|SUPERIORITY||Relative Risk Reduction (RRR)|0.216||||0.018|TWO_SIDED|95.0|0.041|0.359|||Cochran-Mantel-Haenszel|||||0.359|0.041|0.018
74090524|NCT01583218|147734585|SUPERIORITY||Relative Risk Reduction (RRR)|0.254||||0.003|TWO_SIDED|95.0|0.092|0.387|||Cochran-Mantel-Haenszel|||||0.387|0.092|0.003
73956687|NCT01018511|147449431|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.64||0.162|TWO_SIDED|97.5|-2.3|0.5||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.5|-2.3|0.162
73956688|NCT01018511|147449431|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-4.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. placebo on the change from baseline to end of treatment in TUS.||-2.5|-4.9|<0.001
73956689|NCT01018511|147449431|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.4|-1.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/9 mg vs. placebo on the change from baseline to end of treatment in TUS.||-1.9|-4.4|<0.001
73956690|NCT01018511|147449431|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-3.5|-1.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in TUS.||-1.0|-3.5|<0.001
74090525|NCT01583218|147734586|SUPERIORITY|||||||0.554|||||||Chi-squared|||||||0.554
74090526|NCT01583218|147734587|SUPERIORITY||Relative Risk Reduction (RRR)|0.326||||0.092|TWO_SIDED|95.0|-0.069|0.576|||Cochran-Mantel-Haenszel|||||0.576|-0.069|0.092
74090527|NCT01583218|147734588|SUPERIORITY||Relative Risk Reduction (RRR)|0.295||||0.11|TWO_SIDED|95.0|-0.085|0.542|||Cochran-Mantel-Haenszel|||||0.542|-0.085|0.11
73956691|NCT01018511|147449432|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.0|-0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.3|-1.0|<0.001
74090528|NCT01583218|147734589|SUPERIORITY||Relative Risk Reduction (RRR)|0.358||||0.039|TWO_SIDED|95.0|0.02|0.58|||Cochran-Mantel-Haenszel|||||0.580|0.020|0.039
73998068|NCT05032872|147543963|SUPERIORITY|||||||0.52||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.52
73998069|NCT05032872|147543964|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Independent sample T-test comparing the treatment and control group||||.45
73998070|NCT02946853|147544012|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.14|7.21|||Regression, Logistic|||||7.21|0.14|1.00
73998071|NCT02946853|147544013|SUPERIORITY||Mean Difference (Net)|-1.0||||0.974|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.974
73998072|NCT02946853|147544014|SUPERIORITY||Mean Difference (Net)|0.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Some patients did not undergo 6 month echocardiogram due to restrictions related to COVID-19.||||1.00
73998073|NCT02946853|147544015|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.1|84.4|||Fisher Exact|||||84.4|0.1|1.00
73998074|NCT02946853|147544016|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1.00
73998075|NCT02946853|147544017|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|42.0|||Fisher Exact|||||42.00|0.00|1.00
73998076|NCT02946853|147544018|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.005
73998077|NCT02946853|147544019|SUPERIORITY||Median Difference (Final Values)|23.7||||0.565|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.565
73998078|NCT02946853|147544020|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|42.0|||Fisher Exact|||||42.0|0.0|1.00
73998079|NCT01404429|147544023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.6|TWO_SIDED|95.0|-0.26|0.54|||t-test, 2 sided|||||0.54|-0.26|0.6
74090529|NCT03334721|147734596|SUPERIORITY|"Given the crossover design through which the data were collected, the statistical model also included a Visit (1 vs. 2) factor and a Visit by Treatment Condition interaction term. Analysis used Linear Mixed Modeling with Fixed Factors."|Test III Tests of Fixed Effects (F)|0.141||||0.711|TWO_SIDED|||||Treatment Condition Factor (0 = Placebo, 1 = Gabapentin)|Mixed Models Analysis|df = 1, 20.183|||"Given the crossover design through which the data were collected, the statistical model also included a Visit (1 vs. 2) factor and a Visit by Treatment Condition interaction term."|||0.711
74090530|NCT02246439|147734604|SUPERIORITY||Odds Ratio (OR)|1.6081||||0.0406|TWO_SIDED|95.0|1.0194|2.5368||"This P-Value is for the All ages group"|Cochran-Mantel-Haenszel|Stratified by age.||The odds ratio and p-value were from a Cochran-Mantel-Haenszel test. For the 'All ages' category, the odds ratio and p-value were stratified by age.||2.5368|1.0194|0.0406
74090531|NCT02246439|147734604|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0729|TWO_SIDED|95.0|0.847|27.2024||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||27.2024|0.8470|0.0729
74090532|NCT02246439|147734604|SUPERIORITY||Odds Ratio (OR)|1.4755||||0.1089|TWO_SIDED|95.0|0.917|2.3741||"This P-Value is for the 18 years of age and older group"|Cochran-Mantel-Haenszel|||||2.3741|0.9170|0.1089
74090533|NCT02246439|147734605|SUPERIORITY||Odds Ratio (OR)|1.3545||||0.1843|TWO_SIDED|95.0|0.8647|2.1216|||Cochran-Mantel-Haenszel|Stratified by age.||||2.1216|0.8647|0.1843
74090534|NCT02246439|147734606|SUPERIORITY||Odds Ratio (OR)|1.752||||0.0166|TWO_SIDED|95.0|1.1058|2.776|||Cochran-Mantel-Haenszel|Stratified by age.||||2.7760|1.1058|0.0166
74090535|NCT02246439|147734607|SUPERIORITY||Odds Ratio (OR)|0.6677||||0.1049|TWO_SIDED|95.0|0.4093|1.0892|||Cochran-Mantel-Haenszel|Stratified by age.||||1.0892|0.4093|0.1049
73998080|NCT02310100|147544041|OTHER|This is a one-group comparison to a performance goal.|binomial proportion|0.673||||0.0008|ONE_SIDED|95.0|0.608||||Exact binomial|||H0: PE ≤ 54.9% Ha: PE \> 54.9% Where PE is the primary effectiveness endpoint rate.|||0.608|0.0008
73998081|NCT02310100|147544042|OTHER|One group comparison to a performance goal.|binomial proportion|0.081||||0.0013|ONE_SIDED|95.0||0.124|||Exact binomial|||H0: PS ≥ 16.2% Ha: PS \< 16.2% where PS is the primary safety endpoint rate||0.124||0.0013
74036354|NCT00174785|147625197|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.03||95.0|0.51|0.98||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The comparison was performed at the 5% level using a 2-sided Log rank|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of adjudicated cardiovascular death for the dronedarone group compared with the placebo group.|||0.98|0.51|0.03
73998082|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 4||3.3|-6.8|
73998083|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 6B||4.3|-4.6|
74036355|NCT00120289|147625204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8|TWO_SIDED|95.0|0.87|1.21|||Regression, Cox|Adjusting for gender and history of diabetes (randomization stratification factors).||||1.21|0.87|0.80
74036356|NCT00120289|147625205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.49|TWO_SIDED|95.0|0.87|1.34|||Regression, Cox|||||1.34|0.87|.49
74036357|NCT00120289|147625206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.3|TWO_SIDED|95.0|0.9|1.42|||Regression, Cox|||||1.42|0.90|.30
74036358|NCT00120289|147625207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.47|TWO_SIDED|95.0|0.76|1.8|||Regression, Cox|||||1.80|0.76|0.47
74036359|NCT02504268|147625358|SUPERIORITY|||||||0.2359|||||||Regression, Logistic|||||||0.2359
74036360|NCT02504268|147625359|SUPERIORITY|||||||0.0112|||||||Regression, Logistic|||||||0.0112
74036361|NCT02504268|147625360|SUPERIORITY|||||||0.0021|||||||Regression, Logistic|||||||0.0021
74036362|NCT02504268|147625361|SUPERIORITY||||||<|0.0001|||||||rank-based ANCOVA|||||||< 0.0001
74036363|NCT02504268|147625362|SUPERIORITY|||||||0.0006|||||||Regression, Logistic|||||||0.0006
73998084|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 9V||3.3|-6.8|
74036364|NCT00862849|147625372|SUPERIORITY_OR_OTHER||LS Mean Difference|26.47|||<|0.0001|TWO_SIDED|90.0|18.22|34.71||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||34.71|18.22|<0.0001
74036365|NCT00862849|147625372|SUPERIORITY_OR_OTHER||LS Mean Difference|16.7||||0.0015|TWO_SIDED|90.0|8.45|24.94||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed||||24.94|8.45|0.0015
74036366|NCT01580592|147625440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_DEVIATION|7.6||0.001|TWO_SIDED||||||ANOVA||for omalizumab 150mg|||||0.001
74036367|NCT01580592|147625440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4|STANDARD_DEVIATION|9.4||0.01|TWO_SIDED||||||ANOVA|||||||0.01
74036368|NCT01580592|147625440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|3.9|||TWO_SIDED|||||||||||||
74036369|NCT01580592|147625441|SUPERIORITY_OR_OTHER|||||||0.988|||||||Chi-squared|||||||0.988
74036370|NCT03471767|147625448|SUPERIORITY|Multilevel modeling (MLM) was used to model daily reports of cigarettes smoked as a function of week, treatment (AXS-05 vs. bupropion), and the interaction between week and treatment. The contrast between the two treatment groups in change in smoking intensity from baseline to week 3 was estimated within the context of the model.|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.54||0.05|TWO_SIDED|95.0|-2.75|-0.65||This was not adjusted for multiple comparisons, because the primary hypothesis was established a-priori.|t-test, 2 sided|||||-0.65|-2.75|0.05
74036371|NCT03471767|147625454|OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
74036372|NCT00678587|147625455|SUPERIORITY_OR_OTHER||Absolute difference in proportions|52.8|||<|0.0001|TWO_SIDED|95.0|43.2|62.4|||Cochran-Mantel-Haenszel|||||62.4|43.2|<0.0001
74036373|NCT00678587|147625456|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.9|||||TWO_SIDED|95.0|-15.1|3.3||||||||3.3|-15.1|
74036374|NCT00678587|147625457|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74036375|NCT00305253|147625476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.019|TWO_SIDED|95.0|0.17|0.85|||Regression, Logistic|Independent variables were selected on the basis of their significant association with EAO in bivariate analyses (t-tests and logistic regression).|Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|"Relative risks and confidence intervals were computed for the primary outcome, Extreme Adverse Outcomes (EAO) - a combined measure of maternal mortality or severe mobidity.~To estimate the independent effect of the intervention net of the effects of other baseline characteristics, a multiple logistic regression model was used."||0.85|0.17|0.019
74036376|NCT00305253|147625477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.79|||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Mean measured volume of blood loss in the drape was compared across phases with t-tests.||||<0.0001
74090536|NCT02246439|147734608|SUPERIORITY||Odds Ratio (OR)|0.6566||||0.1235|TWO_SIDED|95.0|0.3826|1.1268|||Cochran-Mantel-Haenszel|Stratified by age.||||1.1268|0.3826|0.1235
73876943|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||39.9|-23.7|0.678
73998085|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 14||4.3|-4.6|
73998086|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 18C||4.3|-4.6|
73998087|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 19F||3.3|-6.8|
73998088|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-5.0|||||TWO_SIDED|95.0|-12.3|-0.3|||Chan and Zhang|||Common serotypes - serotype 23F||-0.3|-12.3|
73998089|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|96.3|||||TWO_SIDED|95.0|89.4|99.2|||Chan and Zhang|||Additional serotypes - serotype 1||99.2|89.4|
73998090|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.1|||||TWO_SIDED|95.0|87.7|98.6|||Chan and Zhang|||Additional serotypes - serotype 3||98.6|87.7|
73998091|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|37.2|||||TWO_SIDED|95.0|26.2|48.9|||Chan and Zhang|||Additional serotypes - serotype 5||48.9|26.2|
73998092|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|22.9|||||TWO_SIDED|95.0|14.4|33.4|||Chan and Zhang|||Additional serotypes - serotype 6A||33.4|14.4|
73998093|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|97.6|||||TWO_SIDED|95.0|91.6|99.7|||Chan and Zhang|||Additional serotypes - serotype 7F||99.7|91.6|
73998094|NCT00688870|147544046|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.5|||Chan and Zhang|||Additional serotypes - serotype 19A||4.5|-4.6|
73998095|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 4||3.1|-6.9|
73998096|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 6B||4.4|-4.6|
73998097|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 9V||3.1|-6.9|
73998098|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 14||4.4|-4.6|
74090537|NCT02246439|147734610|SUPERIORITY|||||||0.589||||||This P-Value is for the BSS=7 group.|Wilcoxon (Mann-Whitney)|||||||0.5890
74090538|NCT02246439|147734611|SUPERIORITY||Hazard Ratio (HR)|0.9782||||0.8487|TWO_SIDED|95.0|0.7803|1.2264||"This P-Value is for the All ages group."|Cox proportioanl hazards method|Stratified by age.||||1.2264|0.7803|0.8487
74090539|NCT02246439|147734611|SUPERIORITY||Hazard Ratio (HR)|1.4756||||0.3479|TWO_SIDED|95.0|0.6549|3.325||"This P-Value is for the \<18 years of age group."|Cox proportional hazards method|||||3.3250|0.6549|0.3479
74090540|NCT02246439|147734611|SUPERIORITY||Hazard Ratio (HR)|0.9445||||0.6332|TWO_SIDED|95.0|0.7469|1.1943||"This P-Value is for the 18 years of age of older group."|Cox proportional hazards method|||||1.1943|0.7469|0.6332
74090541|NCT02246439|147734612|SUPERIORITY||Hazard Ratio (HR)|1.0275||||0.8289|TWO_SIDED|95.0|0.8036|1.3138||"This P-Value was for the All ages group."|Cox proportional hazards method|Stratified by age.||||1.3138|0.8036|0.8289
74090542|NCT02246439|147734612|SUPERIORITY||Hazard Ratio (HR)|1.5744||||0.3241|TWO_SIDED|95.0|0.6388|3.8802||"This P-Value is for the \<18 years of age group."|Cox proportional hazards method|||||3.8802|0.6388|0.3241
74090543|NCT02246439|147734612|SUPERIORITY||Hazard Ratio (HR)|0.992||||0.9511|TWO_SIDED|95.0|0.7688|1.2801||"This P-Value is for the 18 years of age or older group."|Cox proportional hazards method|||||1.2801|0.7688|0.9511
74090544|NCT02246439|147734613|SUPERIORITY||Odds Ratio (OR)|2.3012||||0.2005|TWO_SIDED|95.0|0.6221|8.5129|||Cochran-Mantel-Haenszel|||||8.5129|0.6221|0.2005
74090545|NCT02246439|147734614|SUPERIORITY||Odds Ratio (OR)|0.6674||||0.572|TWO_SIDED|95.0|0.1638|2.7191|||Cochran-Mantel-Haenszel|||||2.7191|0.1638|0.5720
73876944|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|4.6||||0.663|TWO_SIDED|95.0|-16.0|25.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||25.2|-16.0|0.663
73876945|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-8.8||||0.494|TWO_SIDED|95.0|-28.7|11.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||11.0|-28.7|0.494
73876946|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|23.2||||0.169|TWO_SIDED|95.0|-1.6|48.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||48.1|-1.6|0.169
73876947|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|30.6||||0.005|TWO_SIDED|95.0|11.5|49.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||49.7|11.5|0.005
73876948|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|0.7||||0.963|TWO_SIDED|95.0|-26.8|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||28.1|-26.8|0.963
73956692|NCT01018511|147449432|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.1|-0.6|0.223
73876949|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|6.7||||0.729|TWO_SIDED|95.0|-19.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||33.2|-19.8|0.729
73876950|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-2.9||||0.804|TWO_SIDED|95.0|-25.8|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||20.0|-25.8|0.804
73876951|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-14.0||||0.306|TWO_SIDED|95.0|-41.1|13.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||13.1|-41.1|0.306
73876952|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|12.9||||0.497|TWO_SIDED|95.0|-14.1|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||40.0|-14.1|0.497
73956693|NCT01018511|147449432|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.5|-0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.8|-1.5|< 0.001
73956694|NCT01018511|147449432|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||-0.4|-1.1|< 0.001
73956695|NCT01018511|147449432|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.002|TWO_SIDED|95.0|-0.9|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.9|0.002
73956696|NCT01018511|147449433|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|23.1|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|16.6|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.6|16.6|< 0.001
73956697|NCT01018511|147449433|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|23.2|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|16.6|29.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.8|16.6|< 0.001
73956698|NCT01018511|147449433|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|27.4|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|21.0|33.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.9|21.0|< 0.001
73956699|NCT01018511|147449433|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|27.6|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|21.1|34.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||34.1|21.1|< 0.001
74036377|NCT00305253|147625478|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||<|0.05|TWO_SIDED|95.0|0.21|0.8|||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Relative risks and confidence intervals were computed for emergency hysterectomy.||0.80|0.21|<0.05
74036378|NCT01019486|147625484|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis||||<0.05
74036379|NCT01019486|147625484|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis.||||<0.05
74036380|NCT01019486|147625484|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between groups with two-tailed analysis||||<0.05
74036381|NCT01019486|147625485|NON_INFERIORITY_OR_EQUIVALENCE|If sufficient subjects were enrolled then it would be expected that the MRI measurement of myocardial blood flow MBF would similar or equivalent to the invasively measured CFR in response to intravenous regadenoson administration.|None insufficient data|2.0||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||No analysis was performed due to limited data.||||0.05
74036382|NCT01019486|147625486|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Comparison between groups using a two-tailed Student t test||||<.05
74039811|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2|TWO_SIDED|95.0|-0.68|0.14|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.14|-0.68|0.2000
73876953|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-0.1||||0.993|TWO_SIDED|95.0|-24.0|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-24.0|0.993
73956700|NCT01018511|147449433|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|3.32||0.189|TWO_SIDED|95.0|-2.2|10.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||10.9|-2.2|0.189
73956701|NCT01018511|147449434|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|14.5|STANDARD_ERROR_OF_MEAN|7.51||0.053|TWO_SIDED|95.0|-0.2|29.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.3|-0.2|0.053
74008587|NCT01368042|147567177|SUPERIORITY_OR_OTHER|||||||0.02|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to physical health scale||||0.02
74008588|NCT01368042|147567177|SUPERIORITY_OR_OTHER|||||||0.01|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to emotional problems scale||||0.01
74008589|NCT01368042|147567177|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Energy/fatigue scale||||<0.001
74008590|NCT01368042|147567177|SUPERIORITY_OR_OTHER|||||||0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Emotional well-being scale||||0.002
74008591|NCT01368042|147567177|SUPERIORITY_OR_OTHER|||||||0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Social functioning scale||||0.002
74008592|NCT01368042|147567177|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Bodily pain scale||||<0.001
74008593|NCT01368042|147567177|SUPERIORITY_OR_OTHER|||||||0.56|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||General health perceptions scale||||0.56
74008594|NCT01368042|147567178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_DEVIATION|41.6||0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.001
74008595|NCT01368042|147567179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|1.4||0.03|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.03
74008596|NCT01368042|147567180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.9||0.06|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.06
74008597|NCT01368042|147567181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|1.7||0.84|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.84
74008598|NCT01368042|147567182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|16.5||0.67|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.67
74008599|NCT01368042|147567183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4|STANDARD_DEVIATION|324.8||0.02|||||||Wilcoxon signed rank test-paired samples||n= 215 (paired samples)|||||0.02
74008600|NCT01368042|147567184|SUPERIORITY_OR_OTHER|||||||0.12|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||||||0.12
74008601|NCT02663271|147567196|SUPERIORITY|We used one-sample log rank test to compare to historical control.|Hazard Ratio (HR)|0.3|||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
74008602|NCT01572675|147567206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||p-student|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for duration of prescription at enrollment||||<0.001
74008603|NCT01572675|147567206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||p-student|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for duration of prescription at enrollment||||<0.001
74008604|NCT01572675|147567211|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||Duration of treatment comparison (More than one year vs Up to thirty days) for intermittent selective COX-2 inhibitor use. The analysis assessed whether long-term treatment was more correlated with intermittent selective COX-2 inhibitor use compared to short-term treatment.||||<0.001
74008605|NCT01572675|147567214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.104
73998099|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 18C||4.4|-4.6|
73998100|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 19F||3.1|-6.9|
73998101|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 23F||4.4|-4.6|
73998102|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.0|||||TWO_SIDED|95.0|87.7|98.6|||Chan and Zhang|||Additional serotypes - serotype 1||98.6|87.7|
73998103|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|82.5|||||TWO_SIDED|95.0|72.0|90.1|||Chan and Zhang|||Additional serotypes - serotype 3||90.1|72.0|
73998104|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|9.6|||||TWO_SIDED|95.0|3.8|18.1|||Chan and Zhang|||Additional serotypes - serotype 5||18.1|3.8|
73998105|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Additional serotypes - serotype 6A||4.4|-4.6|
73998106|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|93.8|||||TWO_SIDED|95.0|86.0|97.9|||Chan and Zhang|||Additional serotypes - serotype 7F||97.9|86.0|
73998107|NCT00688870|147544047|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.2|||||TWO_SIDED|95.0|-3.4|6.5|||Chan and Zhang|||Additional serotypes - serotype 19A||6.5|-3.4|
73998108|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.62|||||TWO_SIDED|95.0|0.5|0.78|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4||0.78|0.50|
73998109|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.7|1.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B||1.17|0.70|
73998110|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.67|||||TWO_SIDED|95.0|0.55|0.82|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V||0.82|0.55|
73998111|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.67|1.06|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14||1.06|0.67|
73998112|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.78|||||TWO_SIDED|95.0|0.63|0.97|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 18C||0.97|0.63|
73998113|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.6|0.94|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F||0.94|0.60|
73998114|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.59|||||TWO_SIDED|95.0|0.46|0.77|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F||0.77|0.46|
73876954|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-23.5||||0.101|TWO_SIDED|95.0|-51.2|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||4.1|-51.2|0.101
73998115|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|202.58|||||TWO_SIDED|95.0|157.04|261.32|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1||261.32|157.04|
73998116|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|24.11|||||TWO_SIDED|95.0|18.46|31.49|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3||31.49|18.46|
73998117|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|5.69|||||TWO_SIDED|95.0|4.37|7.41|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 5||7.41|4.37|
73956702|NCT01018511|147449434|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|14.7|STANDARD_ERROR_OF_MEAN|7.59||0.053|TWO_SIDED|95.0|-0.2|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.6|-0.2|0.053
73998118|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|5.82|||||TWO_SIDED|95.0|4.42|7.67|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A||7.67|4.42|
74090546|NCT02246439|147734615|SUPERIORITY||Odds Ratio (OR)|2.1591||||0.3186|TWO_SIDED|95.0|0.477|9.7735||"This P-Value is for the No nausea or mild nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||9.7735|0.4770|0.3186
73956703|NCT01018511|147449434|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|18.5|STANDARD_ERROR_OF_MEAN|7.37||0.012|TWO_SIDED|95.0|4.1|33.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.0|4.1|0.012
73956704|NCT01018511|147449434|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|18.7|STANDARD_ERROR_OF_MEAN|7.45||0.012|TWO_SIDED|95.0|4.1|33.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.4|4.1|0.012
73998119|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|96.1|||||TWO_SIDED|95.0|75.6|122.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F||122.17|75.60|
73998120|NCT00688870|147544048|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.5|||||TWO_SIDED|95.0|1.23|1.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A||1.83|1.23|
73998121|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMC|0.64|||||TWO_SIDED|95.0|0.49|0.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4||0.84|0.49|
73998122|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.03|||||TWO_SIDED|95.0|0.77|1.36|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B||1.36|0.77|
73998123|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.64|1.05|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V||1.05|0.64|
73998124|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.68|||||TWO_SIDED|95.0|0.51|0.91|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14||0.91|0.51|
73998125|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.57|0.99|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 18C||0.99|0.57|
73998126|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.09|||||TWO_SIDED|95.0|0.83|1.43|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F||1.43|0.83|
73998127|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F||0.92|0.52|
73998128|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|303.73|||||TWO_SIDED|95.0|213.63|431.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1||431.83|213.63|
73998129|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|10.65|||||TWO_SIDED|95.0|7.77|14.62|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3||14.62|7.77|
73998130|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|4.79|||||TWO_SIDED|95.0|3.78|6.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 5||6.08|3.78|
73998131|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|3.05|||||TWO_SIDED|95.0|2.28|4.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A||4.08|2.28|
73998132|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|105.0|||||TWO_SIDED|95.0|75.6|145.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F||145.84|75.60|
74090547|NCT02246439|147734615|SUPERIORITY||Odds Ratio (OR)|1.575||||0.3473|TWO_SIDED|95.0|0.6096|4.0696||"This P-Value is for the Moderate nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.0696|0.6096|0.3473
74090548|NCT02246439|147734615|SUPERIORITY||Odds Ratio (OR)|2.0971||||0.0633|TWO_SIDED|95.0|0.9614|4.5747||"This P-Value is for the Severe nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.5747|0.9614|0.0633
74090549|NCT02246439|147734615|SUPERIORITY||Odds Ratio (OR)|1.6397||||0.2797|TWO_SIDED|95.0|0.6649|4.0437||"This P-Value is for the Nausea as bad as it could have been group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.0437|0.6649|0.2797
74090550|NCT02246439|147734616|SUPERIORITY||Odds Ratio (OR)|1.8673||||0.0103|TWO_SIDED|95.0|1.1572|3.0131||"This P-Value is for the All ages group."|Cochran-Mantel-Haenszel|Stratified by age.||||3.0131|1.1572|0.0103
73998133|NCT00688870|147544049|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|4.45|||||TWO_SIDED|95.0|3.54|5.6|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A||5.60|3.54|
73998134|NCT00688870|147544050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||0.735
73998135|NCT00688870|147544050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||0.533
73998136|NCT00688870|147544050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.039
73998137|NCT00688870|147544050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.059
73998138|NCT00688870|147544050|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||>0.99
73998139|NCT00688870|147544050|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||>0.99
73998140|NCT00688870|147544050|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
73998141|NCT00688870|147544050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.275
73998142|NCT00688870|147544051|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||>0.99
73998143|NCT00688870|147544051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||0.617
73998144|NCT00688870|147544051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.810
73998145|NCT00688870|147544051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.810
73998146|NCT00688870|147544051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.674||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.674
73998147|NCT00688870|147544051|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
73998148|NCT00688870|147544051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.497||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.497
73998149|NCT00688870|147544052|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||>0.99
73998150|NCT00688870|147544052|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||>0.99
73998151|NCT00688870|147544052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.044
73998152|NCT00688870|147544052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.076
73998153|NCT00688870|147544052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.496||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||0.496
73998154|NCT00688870|147544052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.361
73998155|NCT00688870|147544052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.635||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||0.635
74090551|NCT02246439|147734616|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0934|TWO_SIDED|95.0|0.7699|25.145||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||25.1450|0.7699|0.0934
73998156|NCT00688870|147544052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.244
73998157|NCT00688870|147544053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||0.076
73998158|NCT00688870|147544053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.735
73998159|NCT00688870|147544053|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||>0.99
73998160|NCT00688870|147544053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||0.477
73998161|NCT00688870|147544053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.805||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.805
73998162|NCT00688870|147544053|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
73998163|NCT00688870|147544053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.477
73998164|NCT00688870|147544054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.633||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.633
73998165|NCT00688870|147544054|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
73998166|NCT00688870|147544054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.527
73998167|NCT00688870|147544054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.613||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.613
74090552|NCT02246439|147734616|SUPERIORITY||Odds Ratio (OR)|1.7356||||0.0303|TWO_SIDED|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel|||||2.8615|1.0527|0.0303
74090553|NCT02246439|147734617|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0924|TWO_SIDED|95.0|0.7699|25.145||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||25.1450|0.7699|0.0924
73876955|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|7.1||||0.655|TWO_SIDED|95.0|-24.0|38.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||38.3|-24.0|0.655
74036383|NCT03483506|147625660|OTHER||Geometric mean ratio|8.34|STANDARD_DEVIATION|50.5|||TWO_SIDED|90.0|5.88|11.82|||ANOVA||"Standard deviation is actually intra individual geometric coefficient of variation. BI 1467335 tab arm is the numerator, while BI 1467335 (C-14) iv arm is the denominator."|The statistical model used for the analysis of the primary PK endpoints was an ANOVA (analysis of variance) model on the logarithmic scale. The model included effects accounting for 'subject' and 'formulation' as sources of variation; 'subject' was considered as a random effect, whereas 'formulation' was considered as a fixed effect.||11.82|5.88|
73998168|NCT00688870|147544054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.753
73998169|NCT00688870|147544054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.748||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.748
73998170|NCT00688870|147544055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.327
73998171|NCT00688870|147544055|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
73998172|NCT00688870|147544055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.522
73998173|NCT00688870|147544055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.872||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.872
73998174|NCT00688870|147544055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.868
73998175|NCT00688870|147544055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.237
73998176|NCT00688870|147544056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.329
73998177|NCT00688870|147544056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||0.492
73998178|NCT00688870|147544056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.496||95.0|||||Fisher Exact|||For Fever \>40 degrees C, Fisher exact test was used to calculate p-value.||||0.496
73998179|NCT00688870|147544056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.322
73998180|NCT00688870|147544056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.610
73998181|NCT00688870|147544056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.726||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.726
73998182|NCT00688870|147544056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.855||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.855
73998183|NCT00688870|147544057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.326
73998184|NCT00688870|147544057|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
73998185|NCT00688870|147544057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.714||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.714
73998186|NCT00688870|147544057|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||>0.99
73998187|NCT00688870|147544057|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||>0.99
74036384|NCT03483506|147625662|OTHER||Geometric mean ratio|62.14|STANDARD_DEVIATION|24.4|||TWO_SIDED|90.0|52.08|74.14|||ANOVA||"Standard deviation is actually intra individual geometric coefficient of variation. BI 1467335 tab arm is the numerator, while BI 1467335 (C-14) iv arm is the denominator."|The statistical model used for the analysis of the primary PK endpoints was an ANOVA (analysis of variance) model on the logarithmic scale. The model included effects accounting for 'subject' and 'formulation' as sources of variation; 'subject' was considered as a random effect, whereas 'formulation' was considered as a fixed effect.||74.14|52.08|
74090554|NCT02246439|147734617|SUPERIORITY||Odds Ratio (OR)|1.7356||||0.0303|TWO_SIDED|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel|||||2.8615|1.0527|0.0303
74090555|NCT02246439|147734618|SUPERIORITY||Odds Ratio (OR)|1.7922||||0.0152|TWO_SIDED|95.0|1.1188|2.871|||Regression, Logistic|||||2.8710|1.1188|0.0152
73998188|NCT00688870|147544057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.525||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.525
73998189|NCT01821352|147544070|SUPERIORITY_OR_OTHER||||||<|5e-05|TWO_SIDED||||||Fisher Exact|||||||<0.00005
73998190|NCT01821352|147544071|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
73998191|NCT01821352|147544072|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73998192|NCT05745701|147544082|OTHER||test/reference ratios|195.9|||||TWO_SIDED|90.0|162.13|236.71||||||Natural loge transformed Cmax of PF-07081532 administered without cyclosporine (Reference) or coadministered with cyclosporine (Test) were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test/Reference) and corresponding 90% CIs was obtained from the models. The ratios (and 90% CIs) were expressed as percentages.||236.71|162.13|
74090556|NCT02246439|147734619|SUPERIORITY||Odds Ratio (OR)|2.0789||||0.0037|TWO_SIDED|95.0|1.2676|3.4095|||Regression, Logistic|||||3.4095|1.2676|0.0037
74090557|NCT03439852|147734620|SUPERIORITY||Mean Difference (Net)|0.83|||<|0.05|TWO_SIDED|95.0|0.26|1.39|||Mixed Models Analysis|||Multilevel modeling for repeated measures was conducted to compare 2 conditions over time. The model included group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||1.39|0.26|<0.05
73998193|NCT05745701|147544082|OTHER||test/reference ratios|282.13|||||TWO_SIDED|90.0|258.81|307.55||||||Natural loge transformed Cmax of PF-07081532 administered without itraconazole (Reference) or coadministered with itraconazole (Test) were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test/Reference) and corresponding 90% CIs was obtained from the models. The ratios (and 90% CIs) were expressed as percentages.||307.55|258.81|
73998194|NCT01397422|147544103|SUPERIORITY||Least Squares Mean Difference|-11.3||||0.0051|TWO_SIDED|95.0|-19.1|-3.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||20 subjects per treatment arm provided 80% power using a 2-sided 2-sample test at 5% significance. The null hypothesis for the primary endpoint was that the response of the ADS-5102 340 mg group was equal to that of the placebo group.||-3.5|-19.1|0.0051
73998195|NCT01397422|147544103|SUPERIORITY||Least Squares Mean Difference|-10.0||||0.0131|TWO_SIDED|95.0|-17.8|-2.2|||ANCOVA|||||-2.2|-17.8|0.0131
73998196|NCT01397422|147544103|SUPERIORITY||Least Squares Mean Difference|-5.6||||0.1595|TWO_SIDED|95.0|-13.4|2.2|||ANCOVA|||||2.2|-13.4|0.1595
73998197|NCT01397422|147544104|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.4314|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA|||||0.5|-1.1|0.4314
73998198|NCT01397422|147544104|SUPERIORITY||Least Squares Mean Difference|0.3||||0.5223|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||||1.0|-0.5|0.5223
73998199|NCT01397422|147544104|SUPERIORITY||Least Squares Mean Difference|0.2||||0.6298|TWO_SIDED|95.0|-0.6|1.0|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, baseline value is a covariate||||1.0|-0.6|0.6298
73998200|NCT01397422|147544105|SUPERIORITY||Least Squares Mean Difference|-5.2||||0.0038|TWO_SIDED|95.0|-8.7|-1.7|||ANCOVA|||||-1.7|-8.7|0.0038
73998201|NCT01397422|147544105|SUPERIORITY||Least Squares Mean Difference|-6.4||||0.0004|TWO_SIDED|95.0|-9.8|-2.9|||ANCOVA|||||-2.9|-9.8|0.0004
73998202|NCT01397422|147544105|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.1469|TWO_SIDED|95.0|-6.0|0.9|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||||0.9|-6.0|0.1469
73998203|NCT01397422|147544106|SUPERIORITY||Least Squares Mean Difference|3.0||||0.0078|TWO_SIDED|95.0|0.8|5.2|||ANCOVA|||||5.2|0.8|0.0078
73998204|NCT01397422|147544106|SUPERIORITY||Least Squares Mean Difference|2.7||||0.0179|TWO_SIDED|95.0|0.5|5.0|||ANCOVA|||||5.0|0.5|0.0179
73998205|NCT01397422|147544106|SUPERIORITY||Least Squares Mean Difference|3.3||||0.004|TWO_SIDED|95.0|1.1|5.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate||||5.5|1.1|0.0040
73998206|NCT01397422|147544107|SUPERIORITY||Least Squares Mean Difference|-2.2||||0.6355|TWO_SIDED|95.0|-11.2|6.9|||ANCOVA|||||6.9|-11.2|0.6355
73998207|NCT01397422|147544107|SUPERIORITY||Least Squares Mean Difference|1.7||||0.7053|TWO_SIDED|95.0|-7.2|10.6|||ANCOVA|||||10.6|-7.2|0.7053
73998208|NCT01397422|147544107|SUPERIORITY||Least Squares Mean Difference|1.2||||0.7862|TWO_SIDED|95.0|-7.7|10.1|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate||||10.1|-7.7|0.7862
74036385|NCT01934192|147625677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|7.02|||TWO_SIDED|95.0|-5.1|22.9||||||||22.9|-5.1|
73998209|NCT01397422|147544108|SUPERIORITY|||||||0.0036|||||||Cochran-Mantel-Haenszel|||||||0.0036
73998210|NCT01397422|147544108|SUPERIORITY|||||||0.2158|||||||Cochran-Mantel-Haenszel|||||||0.2158
73998211|NCT01397422|147544108|SUPERIORITY|||||||0.1042|||||||Cochran-Mantel-Haenszel|Equally spaced scores||||||0.1042
73998212|NCT01200290|147544164|SUPERIORITY_OR_OTHER|||||||0.324|TWO_SIDED|||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement|||||||0.324
73998213|NCT01200290|147544164|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement|||||||0.031
73998214|NCT01200290|147544164|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement|||||||0.076
73998215|NCT01200290|147544164|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement|||||||0.013
73998216|NCT01200290|147544164|SUPERIORITY_OR_OTHER|||||||0.553|TWO_SIDED|||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement|||||||0.553
73998217|NCT01200290|147544164|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED|||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement|||||||0.132
73998218|NCT01200290|147544164|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement|||||||0.230
73998219|NCT01200290|147544165|SUPERIORITY_OR_OTHER|||||||0.335|TWO_SIDED|||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement|||||||0.335
73998220|NCT01200290|147544165|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement|||||||0.043
73998221|NCT01200290|147544165|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement|||||||0.073
73998222|NCT01200290|147544165|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement|||||||0.004
73998223|NCT01200290|147544165|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED|||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement|||||||0.699
73998224|NCT01200290|147544165|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED|||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement|||||||0.095
73998225|NCT01200290|147544165|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED|||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement|||||||0.082
74008606|NCT01572675|147567214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.0049
74008607|NCT01572675|147567214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.618|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.618
74008608|NCT01572675|147567215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for medical history of arterial hypertension||||0.012
74036386|NCT01934192|147625678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|4.35|||TWO_SIDED|95.0|-6.5|10.9||||||||10.9|-6.5|
74036387|NCT01934192|147625679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|7.03|||TWO_SIDED|95.0|-5.1|22.9||||||||22.9|-5.1|
73998226|NCT04150068|147544184|SUPERIORITY|The difference in percentage between 2 treatment groups was compared using an unconditional exact method using 2 invert 1-sided tests with an alpha level at 0.05 to evaluate superiority.|Percentage Difference|70.8|||<|0.0001|TWO_SIDED|95.0|34.9|90.0||The P value and 95% confidence interval (CI) for the point estimate of treatment difference in proportions was estimated and constructed using the Chan and Zhang method.|Chan & Zhang method|||||90.0|34.9|< 0.0001
73998227|NCT03829475|147544193|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
73998228|NCT02898077|147544240|SUPERIORITY||Hazard Ratio (HR)|0.765||||0.0184|TWO_SIDED|95.0|0.613|0.955|||Log Rank|||||0.955|0.613|0.0184
73998229|NCT02898077|147544241|SUPERIORITY||Hazard Ratio (HR)|0.963|||||TWO_SIDED|95.0|0.771|1.203||||||||1.203|0.771|
73998230|NCT02898077|147544242|SUPERIORITY||Hazard Ratio (HR)|0.761|||||TWO_SIDED|95.0|0.598|0.968||||||||0.968|0.598|
73998231|NCT02898077|147544243|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
73998232|NCT02898077|147544244|SUPERIORITY||Hazard Ratio (HR)|0.905|||||TWO_SIDED|95.0|0.577|1.421||||||||1.421|0.577|
73998233|NCT00359216|147544259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9219||95.0|||||ANCOVA|||The p-value is obtained by F-test in ANCOVA to assess the treatment group difference in changes from baseline, adjusted for baseline.||||0.9219
73998234|NCT00943852|147544338|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period||||||<0.001
73998235|NCT00943852|147544339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period||||||<0.001
73998236|NCT03377699|147544367|NON_INFERIORITY|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.|Mean treatment difference|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.31|0.08|||ANCOVA|||Primary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.||0.08|-0.31|<0.0001
73998237|NCT03377699|147544367|EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.|Mean treatment difference|-0.08||||0.3881|TWO_SIDED|95.0|-0.27|0.11|||ANCOVA|||Secondary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.||0.11|-0.27|0.3881
73998238|NCT00307684|147544402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.89||||0.2586||95.0|-2.2055|7.9774||No adjustment for multiplicity was performed. threshold for significance: 0.05 (2-sided)|ANCOVA|treatment, sex and country as factors, age and baseline sum of inattention and hyperactivity/impulsivity scores as covariate||Based on preliminary results of a controlled study in adults with MPH, the mean (SD=9) change in CAARS total score from randomization to the 4 week post-randomization endpoint was estimated as +2.5 for PR OROS MPH and +14 for placebo. slightly more conservative, a mean change of 3 in the PR OROS MPH group and a mean increase of 10 in the placebo group were expected. With a two-sided type-I error of 5% and a power of 90%, 37 eligible subjects per group were required.||7.9774|-2.2055|0.2586
73998239|NCT00307684|147544405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3942||||0.2616||95.0|-12.1928|3.4044||No adjustment for multiplicity was performed.|ANCOVA|ANCOVA on the ranks with sex, treatment and country as factors and age and baseline score as a covariate||||3.4044|-12.1928|0.2616
74090558|NCT03439852|147734621|SUPERIORITY||Median Difference (Net)|1.14||||0.05|TWO_SIDED|95.0|-0.37|2.64||Calculated|Mixed Models Analysis|||Multilevel modeling conducted for repeated measures comparing minutes per week of light-to-moderate physical activity for participants in two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||2.64|-0.37|0.05
74090559|NCT03439852|147734622|SUPERIORITY||Mean Difference (Net)|-0.72||||0.05|TWO_SIDED|95.0|-2.31|0.88|||Mixed Models Analysis|||Multilevel modeling for the repeated measures was conducted comparing the two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||0.88|-2.31|0.05
73998240|NCT00307684|147544406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39||||0.5458||95.0|-5.5469|10.3213|||ANCOVA|treatment and country as factors baseline score as covariate||||10.3213|-5.5469|0.5458
73998241|NCT02580305|147544407|SUPERIORITY|||||||0.41||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.41
73998242|NCT02580305|147544407|SUPERIORITY|||||||0.9||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.90
73998243|NCT02580305|147544408|SUPERIORITY|||||||0.46||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.46
73998244|NCT02580305|147544408|SUPERIORITY|||||||0.48||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.48
73998245|NCT02580305|147544409|SUPERIORITY|||||||0.83||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.83
73998246|NCT02580305|147544409|SUPERIORITY|||||||0.24||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.24
73998247|NCT02580305|147544410|SUPERIORITY|||||||0.17||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.17
73998248|NCT02580305|147544410|SUPERIORITY|||||||0.14||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.14
74036388|NCT01934192|147625680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|6.74|||TWO_SIDED|95.0|-6.9|19.9||||||||19.9|-6.9|
74036389|NCT03095521|147625718|NON_INFERIORITY|two-sided 95% CIs estimation used to confirm non-inferior efficacy in primary endpoint. A non-inferiority conclusion was made relating to the primary parameter only.||||||0.028|TWO_SIDED|95.0|||||Fisher Exact|||Arm Angal, Arm Antiangin||||0.028
74036390|NCT03095521|147625721|SUPERIORITY|||||||0.482|||||||Wilcoxon (Mann-Whitney)|||||||0.482
74036391|NCT03095521|147625723|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||change from baseline, 2 groups||||0.072
74036392|NCT01536119|147625724|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||0.27|TWO_SIDED|95.0|0.91|1.38|||Chi-squared|||"Power analysis was conducted to a 15 % increase in exclusive breastfeeding rates (from 52% to 67%) with 80% power and an alpha of 0.05. A 25% attrition rate waas added. 107 couples were needed per group. Intention to treat analysis conducted.~Exclusive breastfeeding at 12 weeks"||1.38|0.91|0.27
74036393|NCT01536119|147625725|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19||||0.09||95.0|0.98|1.44|||Chi-squared|||||1.44|0.98|0.09
74036394|NCT01536119|147625726|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.06||95.0|1.0|1.13|||Fisher Exact|||||1.13|1.00|0.06
73998249|NCT02580305|147544411|SUPERIORITY|||||||0.79||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.79
73998250|NCT02580305|147544411|SUPERIORITY|||||||0.92||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.92
73998251|NCT00700427|147544423|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
73998252|NCT00700427|147544425|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||||||0.002
73998253|NCT00700427|147544426|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA|||||||<0.001
73998254|NCT00700427|147544426|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA|||||||0.002
73998255|NCT00700427|147544426|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Inattention Subscale Imputed Score.|ANCOVA|||||||0.009
73998256|NCT00700427|147544426|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA|||||||0.003
73998257|NCT00700427|147544427|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA|||||||<0.001
73998258|NCT00700427|147544427|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA|||||||<0.001
73998259|NCT00700427|147544427|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Inattention Subscale Imputed Score.|ANCOVA|||||||<0.001
73998260|NCT00700427|147544427|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA|||||||<0.001
73998261|NCT00700427|147544428|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
73998262|NCT00700427|147544429|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
73998263|NCT01247285|147544448|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.81|||||TWO_SIDED|90.0|97.37|119.38|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||119.38|97.37|
74036395|NCT01536119|147625727|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.02||95.0|1.01|1.19|||Chi-squared|||||1.19|1.01|0.02
74036396|NCT01536119|147625728|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon (Mann-Whitney)|||Brief scale used||||0.25
74036397|NCT01536119|147625729|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.29
74036398|NCT01536119|147625730|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||||||0.12
74036399|NCT01536119|147625731|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
74036400|NCT01536119|147625732|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
74036401|NCT01536119|147625733|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
74036402|NCT03162055|147625824|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-87.2|STANDARD_ERROR_OF_MEAN|13.3||0.9974|TWO_SIDED|97.5|-117.0|-57.4|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||-57.4|-117.0|0.9974
74036403|NCT03162055|147625825|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|13.1||0.0002|TWO_SIDED|97.5|-32.8|25.9|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||25.9|-32.8|0.0002
74036404|NCT03162055|147625826|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.79|2.95|||Regression, Logistic|ln (1/(1-p))=Treatment+baseline FEV1+BR a/s MDI+stratification factor (prior treatment)+region.p=percentage of participants with increase of \>=100 mL.|Estimate of the log odds of being a responder in the GFF treatment group compared to the UV treatment group using a logistic regression.|||2.95|1.79|<0.0001
74036405|NCT03162055|147625827|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|19.4||0.0371|TWO_SIDED|95.0|-53.4|22.9|||Repeated measures analysis|Change from baseline = Treatment + baseline IC + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||22.9|-53.4|0.0371
73998264|NCT01247285|147544449|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.69|||||TWO_SIDED|90.0|92.9|109.14|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||109.14|92.90|
73998265|NCT01247285|147544450|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.77|||||TWO_SIDED|90.0|93.53|108.56|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.56|93.53|
73998266|NCT01247285|147544451|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.88|||||TWO_SIDED|90.0|98.53|111.64|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.64|98.53|
73998267|NCT01247285|147544452|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.64|||||TWO_SIDED|90.0|99.97|111.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.56|99.97|
73998268|NCT01247285|147544453|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.05|||||TWO_SIDED|90.0|94.76|107.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.77|94.76|
73998269|NCT01141647|147544454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56|||||TWO_SIDED|90.0|1.8|7.07||||||||7.07|1.80|
73998270|NCT01163292|147544475|SUPERIORITY_OR_OTHER|||||||0.144||95.0|||||Wilcoxon Rank Sum|||Week 0||||0.144
73998271|NCT01163292|147544475|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon Rank Sum|||Week 26||||0.004
73998272|NCT01163292|147544475|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon Rank Sum|||Week 52||||0.006
73998273|NCT01163292|147544476|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Fisher Exact|||Week 0||||0.290
73998274|NCT01163292|147544476|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Week 26||||1.000
73998275|NCT01163292|147544476|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||Week 52||||0.001
73998276|NCT01163292|147544477|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Wilcoxon Rank Sum|||||||0.335
73998277|NCT01163292|147544478|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Wilcoxon Rank Sum|||Week 0||||0.266
73998278|NCT01163292|147544478|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Wilcoxon Rank Sum|||Week 26||||0.440
73998279|NCT01163292|147544478|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Wilcoxon Rank Sum|||Week 52||||0.609
73998280|NCT02643472|147544480|SUPERIORITY|||||||0.73|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.73
73998281|NCT02643472|147544481|SUPERIORITY|||||||0.12|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||STAI Y-1 data was used in these statistical analyses.||||0.12
73998282|NCT02643472|147544482|SUPERIORITY|||||||0.03|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.03
73998283|NCT02643472|147544485|SUPERIORITY|||||||0.06|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.06
73998284|NCT02643472|147544486|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
73998285|NCT02643472|147544487|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
73998286|NCT02643472|147544488|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
73998287|NCT02643472|147544489|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Cognitive subscale.||||0.92
73998288|NCT02643472|147544489|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Language subscale.||||0.58
73998289|NCT02643472|147544489|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Motor subscale.||||0.87
73998290|NCT01680640|147544508|SUPERIORITY||Mean Difference (Net)|-3.8|STANDARD_DEVIATION|0.8|=|0.05|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|Regression, Linear|||A total sample size of 100 participants, with a 14% drop out during the study and 43 participants in each group completing the study provided 85% power to detect a difference of 40% in liver fat (in the treatment arm compared with the placebo), using a power calculation test with a 0.05 two-sided significance level. For change in liver fat percentage (and other secondary outcomes), ANCOVA will also be undertaken to assess effect sizes in the intervention group and placebo.||||=0.05
74008609|NCT01572675|147567215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for medical history of arterial hypertension||||0.175
74036406|NCT03162055|147625828|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -1.0 unit.|Least Square Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.59|-0.14|||Repeated measures analysis|TDI focal score = Treatment + Baseline Dyspnea Index + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean TDI focal score over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||-0.14|-0.59|<0.0001
74036407|NCT03162055|147625829|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.023||0.0017|TWO_SIDED|95.0|-0.011|0.078|||Repeated measures analysis|Change from baseline = Treatment + baseline EMSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||0.078|-0.011|0.0017
73998291|NCT01680640|147544508|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Median Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
73998292|NCT01680640|147544509|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end-of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Mean Difference (Final Values)|0.1||||1|TWO_SIDED||||||Regression, Linear|||||||1.00
73998293|NCT01680640|147544510|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Mean Difference (Final Values)|0.2||||0.8|TWO_SIDED||||||Regression, Linear|||||||0.80
73998294|NCT01680640|147544511|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Median Difference (Final Values)|0.97|||<|0.001|TWO_SIDED||||||Beta-diversity indexes|Beta-diversity indexes were first visualized through a Principal Coordinates Analysis (PCoA)||||||<0.001
73998295|NCT00291642|147544521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.35|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-4.61|-2.09|||ANCOVA|||||-2.09|-4.61|<0.001
73998296|NCT00291642|147544521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.25|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-4.5|-2.0|||ANCOVA|||||-2.00|-4.50|<0.001
74036408|NCT03162055|147625830|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.024||0.0088|TWO_SIDED|95.0|-0.005|0.09|||Repeated measures analysis|Change from baseline = Treatment + baseline NiSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||0.090|-0.005|0.0088
74036409|NCT03162055|147625831|SUPERIORITY||Least Square Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.2||0.9995|TWO_SIDED|95.0|0.26|1.04|||Repeated measures analysis|Change from baseline =Treatment + baseline rescue a/s MDI use + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||1.04|0.26|0.9995
74036410|NCT03162055|147625832|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 2.0 unit.|Least Square Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|0.07|1.11|||Repeated measures analysis|Change from baseline = Treatment + baseline CAT score + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||1.11|0.07|<0.0001
74036411|NCT03162055|147625833|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|12.8||0.5516|TWO_SIDED|97.5|-30.3|27.0|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||27.0|-30.3|0.5516
73998297|NCT00291642|147544521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-5.38|-2.88|||ANCOVA|||||-2.88|-5.38|<0.001
73998298|NCT00291642|147544521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-4.99|-2.49|||ANCOVA|||||-2.49|-4.99|<0.001
73998299|NCT01133418|147544609|SUPERIORITY_OR_OTHER|||||||0.36||||||a priori threshold for statistical significance was .05|General Linear Model|||||||.36
73998300|NCT01133418|147544610|SUPERIORITY_OR_OTHER|||||||0.86|||||||General Linear Model|||||||.86
73998301|NCT01133418|147544611|SUPERIORITY_OR_OTHER|||||||0.79|||||||General Linear Model|||||||.79
73998302|NCT01133418|147544612|SUPERIORITY_OR_OTHER|||||||0.77|||||||General Linear Model|||||||.77
73998303|NCT05316701|147544613|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|1e-05|TWO_SIDED|95.0|0.14|0.47|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||0.47|0.14|<0.00001
73998304|NCT05316701|147544614|SUPERIORITY||Hazard Ratio (HR)|0.19||||2e-05|TWO_SIDED|95.0|0.08|0.43|||Gray's test|||Gray's test was stratified by randomization stratification factors.||0.43|0.08|0.00002
73998305|NCT05316701|147544615|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.11823|TWO_SIDED|95.0|0.2|1.22|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||1.22|0.20|0.11823
74036412|NCT02581865|147625834|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|1.8||0.4326|TWO_SIDED|95.0|-4.9|2.1|||Mixed Models Analysis|||||2.1|-4.9|0.4326
74036413|NCT02581865|147625834|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|1.9||0.1835|TWO_SIDED|95.0|-6.2|1.2|||Mixed Models Analysis|||||1.2|-6.2|0.1835
74036414|NCT02581865|147625835|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3812|TWO_SIDED|95.0|-0.7|0.3|||ANOVA|||||0.3|-0.7|0.3812
73998306|NCT05316701|147544616|SUPERIORITY||Hazard Ratio (HR)|0.37||||3e-05|TWO_SIDED|95.0|0.23|0.6|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||0.60|0.23|0.00003
73998307|NCT04696653|147544617|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
73998308|NCT04696653|147544618|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.2|1.8||||||hypertension||1.8|0.2|
73998309|NCT04696653|147544618|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|0.0|2.1||||||dyslipidemia||2.1|0.0|
73998310|NCT04696653|147544618|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.1|2.0||||||diabetes||2.0|0.1|
73998311|NCT04696653|147544619|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||Evidenced based practice||0.1|-0.6|
73998312|NCT04696653|147544619|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||CUSP strategy||0.1|-0.6|
73998313|NCT04696653|147544620|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.2||||||CUSP strategy||0.2|-0.6|
73998314|NCT04696653|147544620|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Evidenced based practice||0.1|-0.5|
73998315|NCT04696653|147544621|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||evidenced based practice||0.1|-0.5|
73998316|NCT04696653|147544621|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.5|0.2||||||CUSP strategy||0.2|-0.5|
74036415|NCT02581865|147625835|SUPERIORITY||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0146|TWO_SIDED|95.0|-1.2|-0.1|||ANOVA|||||-0.1|-1.2|0.0146
73998317|NCT04696653|147544622|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.9|2.2||||||||2.2|0.9|
73998318|NCT04696653|147544623|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.1|1.9||||||||1.9|1.1|
73998319|NCT04696653|147544624|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.7|1.4||||||||1.4|0.7|
73998320|NCT04696653|147544625|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||||2.6|1.2|
73998321|NCT04696653|147544630|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.0|1.6||||||||1.6|1.0|
73998322|NCT04696653|147544631|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
73998323|NCT04696653|147544632|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
73998324|NCT04696653|147544633|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
73998325|NCT04696653|147544634|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
73998326|NCT04696653|147544635|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
73998327|NCT04696653|147544636|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
73998328|NCT04696653|147544637|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||||0.3|-0.1|
73998329|NCT04696653|147544638|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||||0.2|-0.1|
73998330|NCT04696653|147544639|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
73998331|NCT04696653|147544640|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.4|0.0||||||||0.0|-0.4|
73998332|NCT04696653|147544641|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.0|3.3||||||||3.3|1.0|
73998333|NCT01982448|147544693|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|95.0|0.39|23.68|||||Association between HRD status and pathologic response was measured by the odds ratio (OR).|In the Cisplatin treated patients, the relationship between HRD status and pathologic response was conducted by arm using a univariate logistic regression model and a likelihood ratio test with a one-sided type I error of alpha 0.05. Assuming 12.5% unevaluable, prevalence of HR deficiency 60%, 70 evaluable patients per in a given arm, there is \~80% power to detect a response rate of 52% in HR-deficient patients vs a 16% in HR non-deficient patients, corresponding to the Odds Ratio 5.7.||23.68|0.39|
73998334|NCT01982448|147544693|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.19|4.95||||||In the Paclitaxel treated patients, the relationship between HRD status and pathologic response was conducted by arm using a univariate logistic regression model and a likelihood ratio test with a one-sided type I error of alpha 0.05. Assuming 12.5% unevaluable, prevalence of HR deficiency 60%, 70 evaluable patients per in a given arm, there is \~80% power to detect a response rate of 37% in HR-deficient patients vs a 16% in HR non-deficient patients, corresponding to the Odds Ratio 0.62.||4.95|0.19|
73998335|NCT01982448|147544694|SUPERIORITY||Odds Ratio (OR)|2.32|||||TWO_SIDED|95.0|0.23|118.07||||||||118.07|0.23|
73998336|NCT01982448|147544694|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.09|4.14||||||||4.14|0.09|
73998337|NCT02716818|147544721|SUPERIORITY||Mean Difference (Final Values)|-0.069|||=|0.5521|TWO_SIDED|95.0|-0.299|0.161|||ANCOVA|||The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS profile for the natural logarithm of 17-OHP. The SDS profile was calculated as the SDS of log transformed 17-OHP concentration unsigned. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs, with the first and last (13th) weighted one half relative to the intermediate SDSs.||0.161|-0.299|=0.5521
73998338|NCT02716818|147544722|SUPERIORITY||Mean Difference (Final Values)|0.047|||=|0.7405|TWO_SIDED|95.0|-0.234|0.329|||ANCOVA|||Change from Baseline to 24 Weeks in A4 Using an ANCOVA Model - The analysis conducted for the primary endpoint variable analysis of 17-OHP was repeated for A4.||0.329|-0.234|=0.7405
73998339|NCT02716818|147544723|SUPERIORITY||Mean Difference (Final Values)|-0.037|||=|0.8186|TWO_SIDED|95.0|-0.354|0.281|||ANCOVA|||||0.281|-0.354|=0.8186
73998340|NCT02716818|147544723|SUPERIORITY||Mean Difference (Final Values)|-0.135|||=|0.4655|TWO_SIDED|95.0|-0.508|0.237|||ANCOVA|||||0.237|-0.508|=0.4655
73998341|NCT02716818|147544723|SUPERIORITY||Mean Difference (Final Values)|0.065|||=|0.9081|TWO_SIDED|95.0|-1.32|1.451|||ANCOVA|||||1.451|-1.32|=0.9081
73998342|NCT02716818|147544723|SUPERIORITY||Median Difference (Final Values)|0.092|||=|0.6729|TWO_SIDED|95.0|-0.343|0.527|||ANCOVA|||||0.527|-0.343|=0.6729
73998343|NCT02716818|147544723|SUPERIORITY||Mean Difference (Final Values)|0.116|||=|0.5322|TWO_SIDED|95.0|-0.257|0.489|||ANCOVA|||||0.489|-0.257|=0.5322
73998344|NCT02716818|147544723|SUPERIORITY||Mean Difference (Final Values)|-0.568|||=|0.2885|TWO_SIDED|95.0|-1.799|0.662|||ANCOVA|||||0.662|-1.799|=0.2885
73998345|NCT02716818|147544724|SUPERIORITY||Odds Ratio (OR)|0.99|||=|0.9877|TWO_SIDED|95.0|0.45|2.19|||Regression, Logistic|||||2.19|0.45|=0.9877
74036416|NCT02581865|147625836|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3065|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||||0.2|-0.6|0.3065
74036417|NCT02581865|147625836|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.2052|TWO_SIDED|95.0|-0.7|0.2|||Mixed Models Analysis|||||0.2|-0.7|0.2052
73876956|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|15.5||||0.221|TWO_SIDED|95.0|-9.0|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||40.0|-9.0|0.221
73876957|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||20.3|-36.1|0.585
73876958|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|24.6||||0.124|TWO_SIDED|95.0|-4.8|53.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||53.9|-4.8|0.124
73876959|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|15.2||||0.234|TWO_SIDED|95.0|-9.5|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||39.9|-9.5|0.234
73876960|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-4.8||||0.741|TWO_SIDED|95.0|-32.9|23.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||23.4|-32.9|0.741
73876961|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-25.0||||0.544|TWO_SIDED|95.0|-44.0|-6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||-6.0|-44.0|0.544
73998346|NCT02716818|147544724|SUPERIORITY||Odds Ratio (OR)|0.93|||=|0.8498|TWO_SIDED|95.0|0.43|2.02|||Regression, Logistic|||||2.02|0.43|=0.8498
73998347|NCT02716818|147544725|SUPERIORITY||Mean Difference (Final Values)|-0.96|||=|0.156|TWO_SIDED|95.0|-2.294|0.374|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.||0.374|-2.294|=0.156
73876962|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-15.5||||0.238|TWO_SIDED|95.0|-38.2|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||7.3|-38.2|0.238
73998348|NCT02716818|147544725|SUPERIORITY||Median Difference (Final Values)|0.425|||=|0.3392|TWO_SIDED|95.0|-0.455|1.305|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.||1.305|-0.455|=0.3392
73998349|NCT02716818|147544726|SUPERIORITY||Median Difference (Final Values)|0.009|||=|0.2614|TWO_SIDED|95.0|-0.007|0.025|||ANCOVA|||||0.025|-0.007|=0.2614
73876963|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-17.9||||0.364|TWO_SIDED|95.0|-41.1|5.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.4|-41.1|0.364
73956705|NCT01018511|147449434|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|7.49||0.591|TWO_SIDED|95.0|-10.7|18.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||18.7|-10.7|0.591
73956706|NCT01018511|147449435|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.616|TWO_SIDED|95.0|-0.6|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.4|-0.6|0.616
73956707|NCT01018511|147449435|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.319|TWO_SIDED|95.0|-0.7|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.7|0.319
73998350|NCT00581555|147544735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|7.5||0.999|TWO_SIDED|95.0|-14.7|14.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 8.||14.7|-14.7|0.999
73998351|NCT00581555|147544735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|7.5||0.795|TWO_SIDED|95.0|-12.8|16.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 10.||16.7|-12.8|0.795
73998352|NCT00581555|147544735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|7.6||0.758|TWO_SIDED|95.0|-12.5|17.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 12.||17.1|-12.5|0.758
73998353|NCT00581555|147544735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|7.6||0.381|TWO_SIDED|95.0|-8.3|21.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 16.||21.6|-8.3|0.381
73998354|NCT00581555|147544735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|7.8||0.041|TWO_SIDED|95.0|0.8|31.4||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis at randomization to Week 20.||31.4|0.8|0.041
73998355|NCT00581555|147544735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.5|STANDARD_ERROR_OF_MEAN|8.0|<|0.001|TWO_SIDED|95.0|14.8|46.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 24.||46.3|14.8|<0.001
73998356|NCT00581555|147544736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.3||0.049|TWO_SIDED|95.0|0.0|1.2||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||1.2|0.0|0.049
73998357|NCT00581555|147544737|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from randomization to Week 24.||||0.002
73956708|NCT01018511|147449435|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.5|-0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.6|-1.5|< 0.001
73956709|NCT01018511|147449435|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.7|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.7|-1.7|< 0.001
73956710|NCT01018511|147449435|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.4|-0.4||No adjustments to multiplicity were made|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.4|-1.4|< 0.001
73956711|NCT01018511|147449436|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.591|TWO_SIDED|95.0|-0.3|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.5|-0.3|0.591
73956712|NCT01018511|147449436|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.102|TWO_SIDED|95.0|-0.1|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.8|-0.1|0.102
73956713|NCT01018511|147449436|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.204|TWO_SIDED|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-0.6|0.204
73956714|NCT01018511|147449436|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.936|TWO_SIDED|95.0|-0.4|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.4|-0.4|0.936
73956715|NCT01018511|147449436|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.081|TWO_SIDED|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.8|0.081
73956716|NCT01018511|147449437|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.24||0.511|TWO_SIDED|95.0|-0.3|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.6|-0.3|0.511
73956717|NCT01018511|147449437|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.24||0.182|TWO_SIDED|95.0|-0.2|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.8|-0.2|0.182
73956718|NCT01018511|147449437|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.552|TWO_SIDED|95.0|-0.6|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.3|-0.6|0.552
73956719|NCT01018511|147449437|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.891|TWO_SIDED|95.0|-0.4|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo||0.5|-0.4|0.891
73956720|NCT01018511|147449437|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23||0.215|TWO_SIDED|95.0|-0.8|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.2|-0.8|0.215
73956721|NCT01018511|147449438|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.383|TWO_SIDED|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.||0.1|-0.2|0.383
73956722|NCT01018511|147449438|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.08||0.402|TWO_SIDED|95.0|-0.1|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.1|0.402
73998358|NCT00581555|147544738|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Log Rank|Time to first relapse was estimated using the Kaplan-Meier's, and comparisons between groups was performed using log rank tests.||||||0.0003
73998359|NCT00581555|147544739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|2.1|7.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||7.3|2.1|<0.001
73998360|NCT00581555|147544740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|135.2|STANDARD_ERROR_OF_MEAN|42.3||0.001|TWO_SIDED|95.0|52.3|218.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||218.1|52.3|0.001
73998361|NCT00581555|147544741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.6||0.139||95.0|-0.8|5.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||5.5|-0.8|0.139
74090560|NCT03439852|147734623|SUPERIORITY||Mean Difference (Net)|0.96|||<|0.05|TWO_SIDED|95.0|-2.67|4.6|||Mixed Models Analysis|||Multilevel modeling for the repeated measures was conducted comparing the two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation.||4.60|-2.67|<0.05
73998362|NCT00581555|147544742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|1.2||0.956|TWO_SIDED|95.0|-2.3|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 2.||2.5|-2.3|0.956
73998363|NCT00581555|147544742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.41|TWO_SIDED|95.0|-3.6|1.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 4.||1.5|-3.6|0.41
73998364|NCT00581555|147544742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.2||0.844|TWO_SIDED|95.0|-4.8|3.9||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 6.||3.9|-4.8|0.844
74008610|NCT01572675|147567217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for significant past treatments||||0.701
74090561|NCT03439852|147734624|SUPERIORITY||Mean Difference (Net)|-0.76|||<|0.05|TWO_SIDED|95.0|-1.11|-0.4|||Mixed Models Analysis|||||-0.40|-1.11|<0.05
74090562|NCT03439852|147734625|SUPERIORITY||Mean Difference (Net)|-0.62|||<|0.05|TWO_SIDED|95.0|-1.15|0.1|||Mixed Models Analysis|||||0.10|-1.15|<0.05
74090563|NCT03439852|147734626|SUPERIORITY||Median Difference (Net)|-0.49|||<|0.05|TWO_SIDED|95.0|-2.1|1.11|||Mixed Models Analysis|Repeated measures generalized linear model test effects of time/group, \& interaction rate met MVPA, adjusting for within subject correlation.||||1.11|-2.10|<0.05
74090564|NCT03247517|147734634|SUPERIORITY||Least Square Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.98||0.0232|TWO_SIDED|95.0|-8.4|-0.6|||Mixed Models for Repeated Measures|||||-0.6|-8.4|0.0232
74090565|NCT03247517|147734634|SUPERIORITY||Least Square Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.93||0.0091|TWO_SIDED|95.0|-8.9|-1.3|||Mixed Models for Repeated Measures|||||-1.3|-8.9|0.0091
74090566|NCT03247517|147734635|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0042|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.8|0.0042
74090567|NCT03247517|147734635|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.3|-0.9|0.0003
74090568|NCT03247517|147734636|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.54||0.6854|TWO_SIDED|95.0|-3.6|2.4|||ANCOVA|||||2.4|-3.6|0.6854
74090569|NCT03247517|147734636|SUPERIORITY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.49||0.0518|TWO_SIDED|95.0|-5.8|0.0|||ANCOVA|||||0.0|-5.8|0.0518
74036418|NCT02581865|147625837|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.8||0.2215|TWO_SIDED|95.0|-2.7|0.6|||ANCOVA|||||0.6|-2.7|0.2215
74036419|NCT02581865|147625837|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.0566|TWO_SIDED|95.0|-3.3|0.0|||ANCOVA|||||0.0|-3.3|0.0566
74036420|NCT02581865|147625838|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|3.8||0.5689|TWO_SIDED|95.0|-9.8|5.4|||Mixed Models Analysis|||||5.4|-9.8|0.5689
74036421|NCT02581865|147625838|SUPERIORITY||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|4.0||0.232|TWO_SIDED|95.0|-12.8|3.1|||Mixed Models Analysis|||||3.1|-12.8|0.2320
74036422|NCT02581865|147625839|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.1||0.4515|TWO_SIDED|95.0|-3.0|1.3|||Mixed Models Analysis|||||1.3|-3.0|0.4515
74036423|NCT02581865|147625839|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.6289|TWO_SIDED|95.0|-2.8|1.7|||Mixed Models Analysis|||||1.7|-2.8|0.6289
74090570|NCT03247517|147734637|SUPERIORITY||Least Square Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.061||0.2062|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||||0.04|-0.20|0.2062
74090571|NCT03247517|147734637|SUPERIORITY||Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.059||0.0519|TWO_SIDED|95.0|-0.23|0.0|||ANCOVA|||||0.00|-0.23|0.0519
74090572|NCT03247517|147734638|SUPERIORITY||Risk Difference (RD)|18.8||||0.0068|TWO_SIDED|95.0|5.5|32.2|||Regression, Logistic|||||32.2|5.5|0.0068
74090573|NCT03247517|147734638|SUPERIORITY||Risk Difference (RD)|17.6||||0.0095|TWO_SIDED|95.0|4.6|30.5|||Regression, Logistic|||||30.5|4.6|0.0095
73998365|NCT00581555|147544742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.9||0.968|TWO_SIDED|95.0|-1.8|1.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 8.||1.8|-1.8|0.968
73998366|NCT00581555|147544742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.9||0.441|TWO_SIDED|95.0|-1.1|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 10.||2.5|-1.1|0.441
73998367|NCT00581555|147544742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.9||0.3|TWO_SIDED|95.0|-0.9|2.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 12.||2.8|-0.9|0.3
73998368|NCT00581555|147544742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|1.0||0.008|TWO_SIDED|95.0|0.7|4.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 16.||4.5|0.7|0.008
73998369|NCT00581555|147544742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|1.0||0.005|TWO_SIDED|95.0|0.9|5.0||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 20.||5.0|0.9|0.005
73998370|NCT00581555|147544742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.1||0.031|TWO_SIDED|95.0|0.2|4.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 24.||4.6|0.2|0.031
73998371|NCT00581555|147544743|SUPERIORITY_OR_OTHER|||||||0.1196||95.0||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square or Fisher exact test|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from baseline to Week 24.||||0.1196
73998372|NCT03231800|147544830|SUPERIORITY||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|1.059|<|0.001|TWO_SIDED|95.0|-7.351|-3.137|||ANCOVA|||Least squares means, SEs, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects.||-3.137|-7.351|<0.001
73998373|NCT03231800|147544833|SUPERIORITY||Mean Difference (Final Values)|13.86|STANDARD_ERROR_OF_MEAN|5.612||0.016|TWO_SIDED|95.0|2.694|25.017|||ANCOVA|||||25.017|2.694|0.016
73998374|NCT03231800|147544834|SUPERIORITY||Mean Difference (Final Values)|12.06|STANDARD_ERROR_OF_MEAN|5.508||0.031|TWO_SIDED|95.0|1.105|23.017|||ANCOVA|||||23.017|1.105|0.031
73998375|NCT04075994|147544852|SUPERIORITY|||||||0.22||||||A priori threshold for statistical significance p\<0.05.|t-test, 2 sided|||Proportion of days covered assessed as a continuous measure (range 0-1) at 12 months between study arms adjusted for trial stratification factors (type of anticoagulant treatment). We determined that a sample size of 120 in the intervention group and 120 in the control group enables us to detect a minimum difference in PDC as small as 12.6% with 90% power. Power calculations assume use of 2-sided tests with 0.05 significance level.||||0.22
73998376|NCT01941719|147544869|EQUIVALENCE|This trial aims to show the enhanced education is no better and no worse than the standard education|Mean Difference (Final Values)|-0.1212||||0.077|TWO_SIDED|||||significance level set at 0.05|ANCOVA|At each follow-up point, multivariate ANCOVA models were used to test for significant changes from the baseline||A mixed-effect model with repeated measures is used to compare the difference of group over time.||||0.0770
73998377|NCT01941719|147544870|EQUIVALENCE|This trial aims to show the new treatment is no better and no worse||||||0.6638||||||The threshold of significance level set at 0.05|Mixed Models Analysis|||||||0.6638
73998378|NCT01941719|147544871|EQUIVALENCE|The test will compare the number of complications between the two groups|||||<|0.05|||||||ANOVA|||||||< 0.05
73998379|NCT01480219|147544873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.042|TWO_SIDED|95.0|1.02|2.96|||Regression, Cox|||Crude hazard ratio (HR) and corresponding 95 percent (%) confidence interval (CI) were calculated using an unadjusted Cox proportional hazards regression model.||2.96|1.02|0.042
73998380|NCT01480219|147544873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.453|TWO_SIDED|95.0|0.71|2.14|||Regression, Cox|||HR and corresponding 95% CI were calculated using a parsimoniously adjusted Cox proportional hazards regression model.||2.14|0.71|0.453
73998381|NCT01744392|147544875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.73|TWO_SIDED||||||t-test, 2 sided|||Difference between percentages. Increases in value indicate improvement in adherence.||||.73
73998382|NCT01416389|147544884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344|||||||t-test, 1 sided|||This measure is compared between two treatment arms using a one-sided t-test. This measure followed a normal distribution.||||0.344
73998383|NCT01416389|147544885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.608|||||||Chi-squared|||||||0.608
73998384|NCT01416389|147544887|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|||||||Chi-squared|||||||0.365
73998385|NCT00858364|147544910|NON_INFERIORITY|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.83|1.01|||||A hazard ratio \< 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|The primary analysis used the Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.||1.01|0.83|
73998386|NCT00858364|147544910|NON_INFERIORITY|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.83|1.0|||||A hazard ratio \< 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.||1.00|0.83|
73876964|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-46.5|46.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||46.5|-46.5|1.000
73876965|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-10.7||||0.454|TWO_SIDED|95.0|-34.9|13.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||13.5|-34.9|0.454
73998387|NCT00858364|147544910|SUPERIORITY|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.07|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin)||||||0.070
73998388|NCT00858364|147544910|SUPERIORITY|||||||0.047|||||||Log Rank|Unstratified log rank test||||||0.047
73998389|NCT00858364|147544910|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.84|1.02||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).||1.02|0.84|
73876966|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-25.0||||0.063|TWO_SIDED|95.0|-44.0|-6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||-6.0|-44.0|0.063
73956723|NCT01018511|147449438|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.0|-0.3|0.021
73956724|NCT01018511|147449438|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.584|TWO_SIDED|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-0.2|0.584
73956725|NCT01018511|147449438|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.166|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.3|0.166
73956726|NCT01018511|147449439|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.187|TWO_SIDED|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-1.0|0.187
73956727|NCT01018511|147449439|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.203|TWO_SIDED|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-1.0|0.203
73956728|NCT01018511|147449439|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.09|TWO_SIDED|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-1.1|0.090
73956729|NCT01018511|147449439|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.098|TWO_SIDED|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-1.1|0.098
73956730|NCT01018511|147449439|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.772|TWO_SIDED|95.0|-0.7|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.5|-0.7|0.772
73956731|NCT01018511|147449440|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.21|TWO_SIDED|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.9|0.210
73956732|NCT01018511|147449440|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.775|TWO_SIDED|95.0|-0.5|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.6|-0.5|0.775
73956733|NCT01018511|147449440|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.27||0.01|TWO_SIDED|95.0|-1.2|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-1.2|0.010
73956734|NCT01018511|147449440|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.317|TWO_SIDED|95.0|-0.8|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.3|-0.8|0.317
73956735|NCT01018511|147449440|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.196|TWO_SIDED|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.2|-0.9|0.196
73998390|NCT00858364|147544911|NON_INFERIORITY|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.87|1.04|||||A hazard ratio \< 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|The primary analysis of PFS used a Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.||1.04|0.87|
73998391|NCT00858364|147544911|NON_INFERIORITY|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.87|1.04|||||A hazard ratio \< 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.||1.04|0.87|
73998392|NCT00858364|147544911|SUPERIORITY|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.31|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).||||||0.31
74090574|NCT03247517|147734639|SUPERIORITY||Least Square Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.51||0.7629|TWO_SIDED|95.0|-9.1|12.5|||ANCOVA|||||12.5|-9.1|0.7629
74090575|NCT03247517|147734639|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|5.36||0.7648|TWO_SIDED|95.0|-12.1|8.9|||ANCOVA|||||8.9|-12.1|0.7648
73998393|NCT00858364|147544911|SUPERIORITY|||||||0.27|||||||Log Rank|Unstratified log rank test||||||0.27
73998394|NCT00858364|147544911|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.05||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).||1.05|0.88|
73998395|NCT00858364|147544912|SUPERIORITY|If non-inferiority was declared for OS and PFS, superiority would be declared for the transfusion endpoint if the p-value from a two-sided test of significance using the Cochran-Mantel-Haenszel method was less than 0.05 in favor of the darbepoetin alfa group.|Odds Ratio (OR)|0.704|||<|0.001|TWO_SIDED|95.0|0.573|0.864|||Cochran-Mantel-Haenszel||An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|The primary analysis of the incidence of a transfusion or hemoglobin ≤ 8.0 g/dL from day 29 to EOETP was based on the Cochran-Mantel-Haenszel method to test for treatment group differences while adjusting for the randomization stratification factors (geographic region, histology, and screening hemoglobin).||0.864|0.573|< 0.001
73998396|NCT00858364|147544912|OTHER||Odds Ratio (OR)|0.705|||<|0.001|TWO_SIDED|95.0|0.574|0.866|||Regression, Logistic||An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|As a sensitivity analysis a logistic regression analysis was conducted, stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).||0.866|0.574|< 0.001
74090576|NCT03247517|147734640|SUPERIORITY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.99||0.0069|TWO_SIDED|95.0|-4.6|-0.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.7|-4.6|0.0069
74090577|NCT03247517|147734640|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.96||0.0005|TWO_SIDED|95.0|-5.2|-1.5|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.5|-5.2|0.0005
73876967|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||55.2|-35.2|0.544
73998397|NCT00858364|147544914|OTHER||Odds Ratio (OR)|1.173||||0.076|TWO_SIDED|95.0|0.983|1.401|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|||1.401|0.983|0.076
73998398|NCT00858364|147544914|OTHER||Odds Ratio (OR)|1.173||||0.078|TWO_SIDED|95.0|0.982|1.401|||Cochran-Mantel-Haenszel|Unstratified analysis||||1.401|0.982|0.078
73998399|NCT00858364|147544916|OTHER||Odds Ratio (OR)|0.741||||0.003|TWO_SIDED|95.0|0.61|0.901|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|||0.901|0.610|0.003
73998400|NCT00858364|147544916|OTHER||Odds Ratio (OR)|0.758||||0.003|TWO_SIDED|95.0|0.63|0.913|||Cochran-Mantel-Haenszel|Unstratified analysis||||0.913|0.630|0.003
73998401|NCT02217475|147544973|SUPERIORITY||Odds Ratio (OR)|0.816||||0.5194|TWO_SIDED|95.0|0.439|1.516|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||1.516|0.439|0.5194
73998402|NCT02217475|147544974|SUPERIORITY||Odds Ratio (OR)|1.934||||0.0388|TWO_SIDED|95.0|1.035|3.614|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||3.614|1.035|0.0388
73998403|NCT02217475|147544975|SUPERIORITY||Odds Ratio (OR)|1.249||||0.592|TWO_SIDED|95.0|0.553|2.821|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||2.821|0.553|0.5920
73998404|NCT02217475|147544976|SUPERIORITY||Odds Ratio (OR)|1.396||||0.4941|TWO_SIDED|95.0|0.537|3.628|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||3.628|0.537|0.4941
74090578|NCT03247517|147734640|SUPERIORITY||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.05||0.0424|TWO_SIDED|95.0|-4.2|-0.1|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.1|-4.2|0.0424
74090579|NCT03247517|147734640|SUPERIORITY||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.03||0.039|TWO_SIDED|95.0|-4.1|-0.1|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.1|-4.1|0.0390
73998405|NCT02217475|147544977|SUPERIORITY||Odds Ratio (OR)|1.142||||0.8434|TWO_SIDED|95.0|0.305|4.277|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||4.277|0.305|0.8434
73998406|NCT02217475|147544978|SUPERIORITY||Odds Ratio (OR)|2.201||||0.0234|TWO_SIDED|95.0|1.113|4.352|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||4.352|1.113|0.0234
73998407|NCT02217475|147544979|SUPERIORITY||Odds Ratio (OR)|1.154||||0.7474|TWO_SIDED|95.0|0.484|2.752|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||2.752|0.484|0.7474
73998408|NCT00673400|147545049|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Lifestyle (LS)||||0.1340
73998409|NCT00673400|147545049|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||based on 29 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Coping/behavior (C/B)||||0.088
73998410|NCT00673400|147545049|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Depression/self-perception (D/S)||||0.0012
73998411|NCT00673400|147545049|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Embarrassment (E)||||0.0074
73998412|NCT00673400|147545052|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
73998413|NCT00673400|147545052|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
73998414|NCT00673400|147545052|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
73998415|NCT00673400|147545053|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
73998416|NCT00673400|147545053|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
73998417|NCT00673400|147545053|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
73998418|NCT00673400|147545054|SUPERIORITY_OR_OTHER|||||||0.65||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Physical component summary (PCS)||||0.65
73998419|NCT00673400|147545054|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Mental component summary (MCS)||||0.010
74036424|NCT00798694|147625896|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: There is no significant difference in tear break-up time between the group New to Meds and the group Currently on Xalatan at two months."||||0.005
73998420|NCT02576587|147545067|OTHER|Conditional logistic regression was used to assess the relationship of PAF and AHI on matched pairs of case and control.|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.007||0.054|TWO_SIDED|95.0|0.97|1.0|||Conditional logistic regression|||||1.00|0.97|0.054
73998421|NCT02576587|147545067|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA volume on matched pairs of case and control.|Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.007||0.014|TWO_SIDED|95.0|1.0|1.03|||Conditional logistic regression|N = 270 (135 cases and 135 controls)||||1.03|1.00|0.014
73998422|NCT02576587|147545067|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA volume index on matched pairs of case and control.|Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.015||0.03|TWO_SIDED|95.0|1.0|1.06|||Conditional logistic regression|N=268 (134 cases and 134 controls)||||1.06|1.00|0.030
74036425|NCT01774344|147625905|SUPERIORITY||Hazard Ratio (HR)|0.624|||=|1.7e-05|TWO_SIDED|95.0|0.498|0.782|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for stratified IVRS by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.782|0.498|= 0.000017
74090580|NCT03247517|147734641|SUPERIORITY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.2||0.3813|TWO_SIDED|95.0|-3.4|1.3|||ANCOVA|||||1.3|-3.4|0.3813
74090581|NCT03247517|147734641|SUPERIORITY||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.17||0.9506|TWO_SIDED|95.0|-2.4|2.2|||ANCOVA|||||2.2|-2.4|0.9506
74090582|NCT03247517|147734642|SUPERIORITY|||||||0.0254|||||||Chi-squared|||This analysis pertains to Week 1||||0.0254
74090583|NCT03247517|147734642|SUPERIORITY|||||||0.0899|||||||Chi-squared|||This analysis pertains to Week 2||||0.0899
74090584|NCT03247517|147734642|SUPERIORITY|||||||0.007|||||||Chi-squared|||This analysis pertains to Week 3||||0.0070
74090585|NCT03247517|147734642|SUPERIORITY|||||||0.0031|||||||Chi-squared|||This analysis pertains to Week 4||||0.0031
74090586|NCT03247517|147734642|SUPERIORITY|||||||0.0065|||||||Chi-squared|||This analysis pertains to Week 5||||0.0065
74090587|NCT03247517|147734642|SUPERIORITY|||||||0.007|||||||Chi-squared|||This analysis pertains to Week 6||||0.0070
74090588|NCT03247517|147734642|SUPERIORITY|||||||0.0063|||||||Chi-squared|||This analysis pertains to Week 1||||0.0063
74090589|NCT03247517|147734642|SUPERIORITY|||||||0.0123|||||||Chi-squared|||This analysis pertains to Week 2||||0.0123
74090590|NCT03247517|147734642|SUPERIORITY|||||||0.0003|||||||Chi-squared|||This analysis pertains to Week 3||||0.0003
74090591|NCT03247517|147734642|SUPERIORITY|||||||0.0001|||||||Chi-squared|||This analysis pertains to Week 4||||0.0001
74090592|NCT03247517|147734642|SUPERIORITY|||||||0.0025|||||||Chi-squared|||This analysis pertains to Week 5||||0.0025
74090593|NCT03247517|147734642|SUPERIORITY|||||||0.0033|||||||Chi-squared|||This analysis pertains to Week 6||||0.0033
74090594|NCT01388166|147734656|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74090595|NCT01388166|147734657|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
74090596|NCT01388166|147734658|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73998423|NCT02576587|147545067|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical four-chamber (A4C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.013||0.39|TWO_SIDED|95.0|0.96|1.01|||Conditional logistic regression|N=214 (107 cases and 107 controls)||||1.01|0.96|0.39
73998424|NCT02576587|147545067|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical two-chamber (A2C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.013||0.49|TWO_SIDED|95.0|0.97|1.02|||Conditional logistic regression|N=212 (106 cases and 106 controls)||||1.02|0.97|0.49
73998425|NCT02576587|147545068|OTHER||median of change|3.4||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|||Inter-Quartile Range of the change (post minus pre) is (-7.0, 13.7).|||0.16
73998426|NCT02576587|147545069|OTHER||median of change|1.8||||0.088|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-2.0, 6.0).|||||0.088
73998427|NCT02576587|147545070|OTHER||median of change|-3.7||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-8.0, -0.57).|||||0.006
73998428|NCT02576587|147545071|OTHER||median of change|-0.7||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-6.2, 10.7).|||||0.59
73998429|NCT02576587|147545072|OTHER||mean of change|0.62|STANDARD_DEVIATION|4.2||0.65|TWO_SIDED||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.||||||0.65
73998430|NCT02576587|147545073|OTHER||mean of change|-1.7|STANDARD_DEVIATION|12.2||0.65|TWO_SIDED||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.||||||0.65
73998431|NCT04927247|147545114|OTHER||Difference in percentage|7.9||||0.6302|TWO_SIDED|95.0|-15.8|31.7|||Exact Cochran-Mantel-Haenszel test|||||31.7|-15.8|0.6302
73998432|NCT04927247|147545115|OTHER||Hazard Ratio (HR)|0.97||||0.9382|TWO_SIDED|95.0|0.43|2.16|||Stratified log-rank test|||||2.16|0.43|0.9382
73998433|NCT04927247|147545116|OTHER||Difference in percentage|-16.8||||0.1143|TWO_SIDED|95.0|-34.4|0.8|||Exact Cochran-Mantel-Haenszel test|||||0.8|-34.4|0.1143
73998434|NCT04927247|147545117|OTHER||Rate ratio|1.09||||0.7549|TWO_SIDED|95.0|0.63|1.89|||Negative binomial model|||||1.89|0.63|0.7549
73998435|NCT00513305|147545123|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED|95.0||||The p-value is from the Pearson chi-square test for testing the equality of two binomial proportions, assuming normal approximation of the binomial proportions.|Chi-squared|There were no adjustments for covariates. Since the primary endpoint was prespecified, no adjustment for multiplicity of endpoints was introduced||The hypothesis of equal complete remission rates between the two treatment groups was tested using a 2-sided, normal approximation to the difference in binomial proportions test with two-sided alpha equal to 0.05.||||0.425
73998436|NCT00513305|147545124|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.027||||0.829|TWO_SIDED|95.0|0.535|1.973|||Log Rank|||||1.973|0.535|0.829
73998437|NCT00513305|147545125|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.31||||0.527|TWO_SIDED|95.0|0.16|33.343|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.|||33.343|0.160|0.527
73998438|NCT00513305|147545128|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.027||||0.8289|TWO_SIDED|95.0|0.535|1.973|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.|||1.973|0.535|0.8289
73998439|NCT05453201|147545148|OTHER|||||||0.06|||||||paired t-test|||This analysis uses the functional disability subscale from pre- to post-intervention.||||.06
73998440|NCT05453201|147545148|OTHER|||||||0.004|||||||paired t-test|||This analysis uses the symptom severity subscale from pre- to post-intervention.||||.004
73998441|NCT05453201|147545148|OTHER|||||||0.1|||||||paired t-test|||This analysis uses the perceived overall health now subscale (1 item) from pre- to post-intervention.||||.10
73998442|NCT05453201|147545149|OTHER|||||||0.46|||||||paired t-test|||This analysis uses domain 1 from pre- to post-intervention.||||.46
73998443|NCT05453201|147545149|OTHER|||||||0.2|||||||paired t-test|||This analysis uses domain 2 from pre- to post-intervention.||||.20
73998444|NCT05453201|147545149|OTHER|||||||0.42|||||||paired t-test|||This analysis uses domain 3 from pre- to post-intervention.||||.42
73998445|NCT05453201|147545149|OTHER|||||||0.84|||||||paired t-test|||This analysis uses domain 4 from pre- to post-intervention.||||.84
73998446|NCT05453201|147545149|OTHER|||||||0.25|||||||paired t-test|||This analysis uses domain 5 (part 1) from pre- to post-intervention.||||.25
73998447|NCT05453201|147545149|OTHER|||||||0.26|||||||paired t-test|||This analysis uses domain 6 from pre- to post-intervention.||||.26
73998448|NCT05453201|147545150|OTHER|||||||0.89|||||||Wilcoxon test|||This analysis uses the SBQ-R total score from pre- to post-intervention.||||.89
73998449|NCT05453201|147545151|OTHER|||||||0.8|||||||paired t-test|||This analysis uses the MOCS (part A) from pre- to post-intervention.||||.80
73998450|NCT05453201|147545152|OTHER|||||||0.92|||||||paired t-test|||This analysis uses the FSCQ score (all items) from pre- to post-intervention.||||.92
73998451|NCT05453201|147545152|OTHER|||||||0.9|||||||Wilcoxon test (paired)|||This analysis uses the FSCQ similarity subscale from pre- to post-intervention.||||.90
73998452|NCT05453201|147545152|OTHER|||||||0.74|||||||paired t-test|||This analysis uses the FSCQ vividness subscale from pre- to post-intervention.||||.74
73998453|NCT05453201|147545152|OTHER|||||||0.44|||||||paired t-test|||This analysis uses the FSCQ positivity subscale from pre- to post-intervention.||||.44
73998454|NCT05453201|147545153|OTHER|||||||0.003|||||||paired t-test|||This analysis uses the PHQ-9 from pre- to post-intervention.||||.003
73998455|NCT05453201|147545154|OTHER|||||||0.01|||||||paired t-test|||This analysis uses the GAD-7 from pre- to post-intervention.||||.01
73998456|NCT05453201|147545155|OTHER|||||||0.04|||||||paired t-test|||This analysis uses the QOLS from pre- to post-intervention.||||.04
74008611|NCT01572675|147567217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for significant past treatments||||0.007
73876968|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||14.6|-25.5|0.663
73876969|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||0.6|-30.6|0.251
73876970|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
73876971|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||13.0|-13.4|1.000
73876972|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|2.1||||1|TWO_SIDED|95.0|-14.4|18.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||18.7|-14.4|1.000
73876973|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|1.000
73876974|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||17.7|-18.7|1.000
73876975|NCT02365649|147294852|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|0.501
73998457|NCT05453201|147545156|OTHER|"The AIM measures an intervention's acceptability. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention acceptability. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the AIM at pre- and post-intervention."||||||0.24|||||||Paired t-test|||||||.24
74090597|NCT04295135|147734721|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.001|<|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.05
73876976|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|30.0||||0.155|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.155
73876977|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|30.0||||0.024|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.024
73876978|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-3.3||||1|TWO_SIDED|95.0|-40.1|33.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||33.4|-40.1|1.000
73876979|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-8.6||||0.633|TWO_SIDED|95.0|-46.4|29.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||29.2|-46.4|0.633
73876980|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-24.7|27.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||27.2|-24.7|1.000
73876981|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-24.4||||0.209|TWO_SIDED|95.0|-61.3|12.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||12.5|-61.3|0.209
74090598|NCT04295135|147734722|SUPERIORITY||Median Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.001|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
73876982|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|25.0||||0.283|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.283
73876983|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
73998458|NCT05453201|147545156|OTHER|"The IAM measures an intervention's appropriateness. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention appropriateness. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the IAM at pre- and post-intervention."||||||0.82|||||||Paired t-test|||||||.82
73876984|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-41.7||||0.048|TWO_SIDED|95.0|-77.8|-5.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-5.5|-77.8|0.048
73998459|NCT05453201|147545156|OTHER|||||||0.38|||||||Paired t-test|||"The FIM measures an intervention's feasibility. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention feasibility. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the FIM at pre- and post-intervention."||||.38
73998460|NCT03798691|147545157|SUPERIORITY|||||||0.16|||||||Mann-Whitney U test|||one month after series completion of two dose series||||0.16
73998461|NCT04155203|147545164|EQUIVALENCE|The primary efficacy endpoint was the proportion of subjects in each treatment group with clinical cure, defined as a SIRS score of 0 for all signs and symptoms at Visit 4/Follow-up (7 days after the end of treatment).|equivalence ratio|0.97|||||TWO_SIDED|90.0|-8.19|2.7||||||||2.70|-8.19|
73998462|NCT02489968|147545165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.97|-0.67|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 10 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 10 mg + placebo)|||-0.67|-0.97|<0.0001
73998463|NCT02489968|147545165|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.73|-0.45|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 25 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 25 mg + placebo)|||-0.45|-0.73|<0.0001
73998464|NCT01865747|147545180|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.74|||Log Rank|The Log-Rank Test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) group and number of prior VEGFR TKIs.||||0.74|0.45|<0.0001
73998465|NCT01865747|147545181|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0003|TWO_SIDED|95.0|0.53|0.83|||Log Rank|The Log-Rank test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group and number of prior VEGFR TKIs.||||0.83|0.53|0.0003
73998466|NCT01865747|147545182|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73998467|NCT00611975|147545196|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.8|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.8
73998468|NCT00611975|147545196|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.4|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.4
73998469|NCT00611975|147545197|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.6|||||||Mixed Models Analysis|||Asex questionnaires were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for ASEX scores were re-assigned to phase based on time to onset of next menstrual period. Follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-2 days before NMP).||||>0.6
73998470|NCT00611975|147545197|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.6|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on ASEX scores||||>0.6
73998471|NCT00611975|147545198|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||<.01
73998472|NCT00611975|147545198|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<0.01
73998473|NCT00611975|147545199|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.4|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.4
73998474|NCT00611975|147545199|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
74008612|NCT01572675|147567217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.955|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for significant past treatments||||0.955
74036426|NCT01774344|147625905|SUPERIORITY||Hazard Ratio (HR)|0.66|||=|0.000149|TWO_SIDED|95.0|0.527|0.828|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for stratified RAVE (Sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.828|0.527|= 0.000149
74036427|NCT01774344|147625905|SUPERIORITY||Hazard Ratio (HR)|0.674|||=|0.000107|TWO_SIDED|95.0|0.546|0.831|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for unstratified (sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.831|0.546|= 0.000107
74036428|NCT01774344|147625906|SUPERIORITY||Hazard Ratio (HR)|0.439|||<|1e-06|TWO_SIDED|95.0|0.355|0.542|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.542|0.355|< 0.000001
74090599|NCT04295135|147734723|SUPERIORITY||Mean Difference (Net)|0.022|STANDARD_ERROR_OF_MEAN|0.008|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
73998475|NCT00611975|147545200|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.7|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.7
73998476|NCT00611975|147545200|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
73998477|NCT00611975|147545201|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.9
73998478|NCT00611975|147545201|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
73998479|NCT00611975|147545202|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.9
73998480|NCT00611975|147545202|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.9
73998481|NCT00611975|147545203|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.1|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.1
73998482|NCT00611975|147545203|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.7|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.7
73998483|NCT03465904|147545213|SUPERIORITY|Our power analysis indicated that a minimum of 239 patients per group was needed to provide 90% power to detect a 13.4% difference in the primary outcome, pain freedom at 2 h. Accounting for an estimated attrition rate of 20%, we aimed to enroll 299 patients per group.|||||<|0.05||||||All analyses were performed using SPSS, version 26.0 with two-sided levels of statistical significance established at p \< 0.05|Chi-squared|A Chi-square test of independent proportions was used to compare primary and secondary efficacy outcomes between groups.||Identical statistical analyses were performed for the intent-to-treat (ITT) and the per protocol (PP) populations. The ITT population consisted of all randomized patients, who received any duration of sham or verum treatment and returned completed study materials. The PP population consisted of patients who strictly met inclusion criteria and completed at least 60 min of treatment.||||<0.05
74036429|NCT01774344|147625906|SUPERIORITY||Hazard Ratio (HR)|0.471|||<|1e-06|TWO_SIDED|95.0|0.388|0.572|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.572|0.388|< 0.000001
74036430|NCT01774344|147625906|SUPERIORITY||Hazard Ratio (HR)|0.412|||<|1e-06|TWO_SIDED|95.0|0.334|0.509|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.509|0.334|< 0.000001
73998484|NCT02980731|147545237|SUPERIORITY||||||=|0.004||||||P-value is derived from a paired t-test of H0: mean difference (Week 48 - baseline) ≤ 5 versus H1: mean difference (Week 48 - baseline) \> 5|t-test, 2 sided|||||||=0.004
73998485|NCT00591721|147545271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.53|STANDARD_DEVIATION|6.47|<|0.05|TWO_SIDED|95.0|-15.47|10.41|||t-test, 2 sided|Each baseline subscale score was subtracted from 7 week subscale score; t-tests assessed mean individual differences between groups.||Hypothesis: Individuals who participate in the program will report significantly reduced fatigue impact immediately post-intervention compared to individuals allocated to the wait-list control group.||10.41|-15.47|<0.05
74036431|NCT01774344|147625906|SUPERIORITY||Hazard Ratio (HR)|0.444|||<|1e-06|TWO_SIDED|95.0|0.365|0.539|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.539|0.365|< 0.000001
74090600|NCT04295135|147734724|SUPERIORITY||Median Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.006|>|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||>0.05
74090601|NCT04295135|147734725|SUPERIORITY||Median Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.001|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
73876985|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|21.4||||0.408|TWO_SIDED|95.0|-18.6|61.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||61.4|-18.6|0.408
73998486|NCT03809429|147545276|OTHER||Difference|1.31||||0.0185|TWO_SIDED|95.0|0.22|2.4|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||||2.40|0.22|0.0185
73998487|NCT03809429|147545279|OTHER||Difference|1.14||||0.0281|TWO_SIDED|95.0|0.12|2.15|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=10 mm at end of stimulation||2.15|0.12|0.0281
73998488|NCT03809429|147545279|OTHER||Difference|0.99||||0.0258|TWO_SIDED|95.0|0.12|1.86|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=12 mm at end of stimulation||1.86|0.12|0.0258
73998489|NCT03809429|147545279|OTHER||Difference|0.58||||0.0672|TWO_SIDED|95.0|-0.04|1.2|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=15 mm at end of stimulation||1.20|-0.04|0.0672
73998490|NCT03809429|147545279|OTHER||Difference|0.21||||0.339|TWO_SIDED|95.0|-0.22|0.63|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=17 mm at end of stimulation||0.63|-0.22|0.3390
73998491|NCT03809429|147545281|OTHER||Difference|1.11||||0.0962|TWO_SIDED|95.0|-0.2|2.41|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||||2.41|-0.20|0.0962
73998492|NCT03809429|147545283|OTHER||Difference|0.51||||0.1894|TWO_SIDED|95.0|-0.25|1.27|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of embryos||1.27|-0.25|0.1894
73998493|NCT03809429|147545283|OTHER||Difference|-0.03||||0.9361|TWO_SIDED|95.0|-0.68|0.63|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of Good-quality embryos||0.63|-0.68|0.9361
73998494|NCT03809429|147545284|OTHER||Difference|0.37||||0.2025|TWO_SIDED|95.0|-0.2|0.94|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Total number of blastocysts||0.94|-0.20|0.2025
73998495|NCT03809429|147545284|OTHER||Difference|0.12||||0.5946|TWO_SIDED|95.0|-0.31|0.54|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of good-quality blastocysts||0.54|-0.31|0.5946
73998496|NCT03809429|147545290|OTHER||Difference|16.94|||<|0.0001|TWO_SIDED|95.0|12.13|21.74|||ANOVA|ANOVA model with treatment, age strata, and AMH group as factors.||||21.74|12.13|<0.0001
73998497|NCT03809429|147545291|OTHER||Difference|1.56|||<|0.0001|TWO_SIDED|95.0|1.19|1.92|||ANOVA|ANOVA model with treatment, age strata, and AMH group as factors.||||1.92|1.19|<0.0001
73998498|NCT03809429|147545292|OTHER||Difference|6.99||||0.1579|TWO_SIDED|95.0|-2.71|16.7|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||16.70|-2.71|0.1579
73998499|NCT03809429|147545294|OTHER||Difference|7.66||||0.1134|TWO_SIDED|95.0|-1.82|17.14|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||17.14|-1.82|0.1134
73998500|NCT03809429|147545295|OTHER||Difference|8.81||||0.0642|TWO_SIDED|95.0|-0.52|18.14|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||18.14|-0.52|0.0642
73998501|NCT03809429|147545296|OTHER||Difference|7.74||||0.1002|TWO_SIDED|95.0|-1.49|16.97|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||16.97|-1.49|0.1002
73998502|NCT03828747|147545303|SUPERIORITY||Least Squares Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|0.849||0.0008|TWO_SIDED|95.0|-4.56|-1.21|||Mixed Models Analysis|||Change from Baseline at Week 49||-1.21|-4.56|0.0008
73998503|NCT03828747|147545303|SUPERIORITY||Least Squares Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|1.287||0.0351|TWO_SIDED|95.0|-5.31|-0.2|||Mixed Models Analysis|||Change from Baseline at Week 61||-0.20|-5.31|0.0351
73998504|NCT03828747|147545304|SUPERIORITY||Least Squares Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.295||0.5207||95.0|-3.39|1.72|||Mixed Models Analysis|||Change from Baseline at Week 49||1.72|-3.39|0.5207
73998505|NCT03828747|147545304|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.911||0.3704||95.0|-5.5|2.07|||Mixed Models Analysis|||Change from Baseline at Week 61||2.07|-5.50|0.3704
73998506|NCT03828747|147545305|SUPERIORITY||Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.282||0.3501||95.0|-0.29|0.82|||Mixed Models Analysis|||Change from Baseline at Week 49||0.82|-0.29|0.3501
73998507|NCT03828747|147545305|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.525||0.7431|TWO_SIDED|95.0|-0.87|1.22|||Mixed Models Analysis|||Change from Baseline at Week 61||1.22|-0.87|0.7431
73998508|NCT03828747|147545306|SUPERIORITY||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.429||0.5366||95.0|-0.58|1.11|||Mixed Models Analysis|||Change from Baseline at Week 49||1.11|-0.58|0.5366
74036432|NCT01774344|147625907|SUPERIORITY||Hazard Ratio (HR)|0.453|||<|1e-06|TWO_SIDED|95.0|0.369|0.555|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.555|0.369|< 0.000001
74036433|NCT01774344|147625907|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|1e-06|TWO_SIDED|95.0|0.397|0.58|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.580|0.397|< 0.000001
74036434|NCT01774344|147625907|SUPERIORITY||Hazard Ratio (HR)|0.425|||<|1e-06|TWO_SIDED|95.0|0.347|0.522|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.522|0.347|< 0.000001
74036435|NCT01774344|147625907|SUPERIORITY||Hazard Ratio (HR)|0.454|||<|1e-06|TWO_SIDED|95.0|0.376|0.548|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.548|0.376|< 0.000001
74036436|NCT01774344|147625908|SUPERIORITY||Difference|-6.88|||=|0.00365|TWO_SIDED|95.0|-11.13|-2.63|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-2.63|-11.13|= 0.003650
73876986|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|25.0||||0.126|TWO_SIDED|95.0|-5.5|55.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.5|-5.5|0.126
74036437|NCT01774344|147625908|SUPERIORITY||Difference|-4.15|||=|0.019991|TWO_SIDED|95.0|-7.55|-0.75|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-0.75|-7.55|= 0.019991
74036438|NCT01774344|147625909|SUPERIORITY||Difference|-29.31|||<|1e-06|TWO_SIDED|95.0|-37.52|-21.11|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-21.11|-37.52|< 0.000001
74036439|NCT01774344|147625909|SUPERIORITY||Difference|-31.39|||<|1e-06|TWO_SIDED|95.0|-39.57|-23.22|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-23.22|-39.57|< 0.000001
74036440|NCT01735617|147625920|SUPERIORITY_OR_OTHER||Geometric means|563.38|STANDARD_DEVIATION|162.51|||TWO_SIDED|||||||||The pharmacokinetic profile was characterised by an overnight rise in cortisol levels reaching a maximal concentration approximately 8 hours post dosing.||||
74036441|NCT02344407|147625930|SUPERIORITY|||||||0.68|||||||Chi-squared|Bernards Exact Test Chi-square||Each active vaccine is compared to the placebo group||||0.68
74036442|NCT02344407|147625930|SUPERIORITY|||||||0.68|||||||Chi-squared|Barnard Exact Test Chi-square||||||0.68
74036443|NCT02344407|147625931|SUPERIORITY||||||<|0.001|||||||ANCOVA|Linear regression (analysis of covariance) adjusted for baseline antibody level||||||<0.001
73876987|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-16.7||||0.454|TWO_SIDED|95.0|-54.5|21.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||21.1|-54.5|0.454
74036444|NCT02344407|147625931|SUPERIORITY||||||<|0.001|||||||ANCOVA|Analysis of covariance adjusting for baseline antibody level||||||<0.001
74036445|NCT01102218|147625980|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74036446|NCT01658579|147625987|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|2.179||0.7304|TWO_SIDED|95.0|-3.614|5.124|||Linear Mixed Model|||Analysis was performed using a linear mixed model with treatment and period as fixed effects, and participant as random effect.||5.124|-3.614|0.7304
74036447|NCT00608530|147626017|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Repeated measures analysis of variance compared differences between and within groups (CBT and Supportive Care) from baseline to end of treatment. Statistical testing was performed using 2-tailed tests and alpha level of .05 for declaring statistical significance. The trial was powered at the \>.80 level to detect differences between condition based on projected sample N = 130; given the N = 66 actually achieved our a priori power for detecting differences between groups was .63.||||.05
74036448|NCT00608530|147626018|SUPERIORITY|||||||0.05|||||||ANOVA|||Primary analyses consisted of modified intent-to-treat analysis of all randomized participants who attended at least 1 treatment session, with multiple imputation to address missing data. The study was powered at 80% to detect large effect sizes (\>.50SD) and alpha of .05 with a recruitment goal N = 140; with the N = 61 actually obtained, our a priori power was .55 to detect between group differences.||||.05
74036449|NCT00608530|147626019|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance comparing groups at baseline and end of treatment.||||>0.05
74036450|NCT00608530|147626021|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||.05
74036451|NCT02841787|147626030|SUPERIORITY||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||< .001
74036452|NCT02841787|147626030|SUPERIORITY||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||<.001
74036453|NCT02841787|147626030|SUPERIORITY|||||||0.44||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.44
74036454|NCT02841787|147626030|SUPERIORITY|||||||0.03||||||The threshold for significance was alpha=0.05.|ANOVA|||||||0.03
74036455|NCT02841787|147626030|SUPERIORITY|||||||0.68||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.68
74036456|NCT02841787|147626030|SUPERIORITY|||||||0.02||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.02
74036457|NCT02841787|147626030|SUPERIORITY|||||||0.03||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.03
74036458|NCT02841787|147626033|SUPERIORITY|||||||0.003||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.003
74036459|NCT02951988|147626073|SUPERIORITY|||||||0.5305|||||||Log Rank|||||||0.5305
74036460|NCT02951988|147626073|SUPERIORITY|||||||0.4628|||||||Log Rank|||||||0.4628
74036461|NCT02951988|147626074|SUPERIORITY|||||||0.6153|||||||Log Rank|||||||0.6153
74036462|NCT02951988|147626074|SUPERIORITY|||||||0.4123|||||||Log Rank|||||||0.4123
73998509|NCT03828747|147545306|SUPERIORITY||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.618||0.0851||95.0|-0.15|2.3|||Mixed Models Analysis|||Change from Baseline at Week 61||2.30|-0.15|0.0851
73998510|NCT01144052|147545317|NON_INFERIORITY_OR_EQUIVALENCE|No statistical hypothesis tests for efficacy were performed as this was a pilot study serving to generate first data and hypotheses.||||||0.125||95.0|||||Log Rank|||||||0.125
73998511|NCT01144052|147545318|SUPERIORITY_OR_OTHER|||||||0.447||95.0|||||non-parametric|||||||0.447
73998512|NCT01144052|147545319|SUPERIORITY_OR_OTHER|||||||0.447|||||||non-parametric|||||||0.447
73998513|NCT01144052|147545320|SUPERIORITY_OR_OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
73998514|NCT01144052|147545322|NON_INFERIORITY_OR_EQUIVALENCE|No statistical hypothesis tests for efficacy were performed, as this was pilot study serving to generate first data and hypotheses.||||||0.234||95.0|||||Wilcoxon (Mann-Whitney)|p-value refers to nT2L at month 12||||||0.234
73998515|NCT00355199|147545330|SUPERIORITY||Hazard Ratio (HR)|0.99|||<|0.05|TWO_SIDED|95.0|0.66|1.48|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.48|0.66|<0.05
73998516|NCT00355199|147545332|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.05|TWO_SIDED|95.0|0.29|1.21|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.21|0.29|<0.05
73998517|NCT00355199|147545333|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.57|1.52|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.52|0.57|<0.05
73998518|NCT02503852|147545337|SUPERIORITY|||||||0.032|||||||ANCOVA|||||||0.032
73998519|NCT02503852|147545337|OTHER|||||||0.0318||||||P value cited is the difference in non-vellus hair count between the low-dose ADRC NW3 group and the no-fat saline control at week 24|ANCOVA|||Non-vellus hair count in the low-dose ADRC group in the NW3 subgroup beginning at Week 6 (mean change from baseline persisting through weeks 12 , 24, and 52.||||0.0318
73998520|NCT03980808|147545344|EQUIVALENCE|A priori significance levels were set to 0.05. As this was a pilot study on a demonstration intervention, power analysis were not performed.|Mean Difference (Net)|1.33|STANDARD_ERROR_OF_MEAN|0.56||0.95|TWO_SIDED||||||ANOVA|Total degrees of freedom (dof) = 17, with between groups dof = 1 and within groups dof = 16.||Composite scores were calculated for the knowledge based tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.||||0.95
73998521|NCT03980808|147545345|EQUIVALENCE|A priori significance levels were set to 0.05. As this was a pilot study on a demonstration intervention, power analysis were not performed.|Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|0.5376||0.093|TWO_SIDED||||||ANOVA|||Composite scores were calculated for the behavioral self-report tests tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.||||0.093
73998522|NCT01655693|147545346|SUPERIORITY||Hazard Ratio (HR)|1.0|||>|0.991|TWO_SIDED|95.0||||Treatment comparison of DT pooled with BCS used non-stratified Log-rank test at significance level p=0.05.|Log Rank|Log rank test is used after checking the proportional hazards (PH) assumption is valid. The Wilcoxon test is used when the PH assumption fails.|The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) corresponding to 95% confidence interval (CI) and type II error rate as 15%.|Initial 24 month assessment: the primary aim was to demonstrate the superiority of DT pooled (20 mg/m2 and 30 mg/m2) compared to BSC treatment and not individual DT groups per protocol. OS was estimated using the Kaplan-Meier method. The comparison of treatment groups (pooled DT groups versus BSC group) was performed using a non-stratified log-rank test as the primary analysis. The Cox model and Wilcoxon test was used for sensitivity analysis.||||>0.991
73998523|NCT01655693|147545346|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.796|TWO_SIDED|95.0||||Treatment comparison of DT pooled with BCS used non-stratified Log-rank test at significance level p=0.05.|Log Rank|Log rank test is used after checking the proportional hazards (PH) assumption is valid. The Wilcoxon test is used when the PH assumption fails.|The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) corresponding to 95% confidence interval (CI) and type II error rate as 15%.|Follow-up 45 month assessment: the primary aim was to demonstrate the superiority of DT pooled (20 mg/m2 and 30 mg/m2) compared to BSC treatment and not individual DT groups per protocol. OS was estimated using the Kaplan-Meier method. The comparison of treatment groups (pooled DT groups versus BSC group) was performed using a non-stratified log-rank test as the primary analysis. The Cox model and Wilcoxon test was used for sensitivity analysis.||||0.796
73998524|NCT01655693|147545347|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7|TWO_SIDED|95.0||||Treatment comparison with BCS using non-stratified Log-rank test at significance level p=0.05.|Log Rank||Hazard ratio for treatment variable was determined by Cox model. The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) and type II error rate as 15%.|PFS was estimated using Kaplan-Meier methods and plotted as curves by treatment group. For comparison between treatment groups (pooled DT 20 mg/m2 and 30 mg/m2 versus BSC) used Log-rank test as primary analysis. Hazard ratio, mean, and mean PFS rate were given with corresponding 95% CI.||||0.7
73998525|NCT01655693|147545348|SUPERIORITY|||||||1||||||Treatment comparison with BCS using Fisher's exact test at significance level p=0.05.|Fisher Exact|||The comparisons between groups (pooled DT 20 mg/m2 and 30mg/m2 versus BSC) used Fisher's exact test.||||1.0
73998526|NCT02285153|147545375|SUPERIORITY||Cox Proportional Hazard|0.434|STANDARD_ERROR_OF_MEAN|1.225||0.57|TWO_SIDED|95.0|0.039|4.792||Due to the low number of participants, the results of the statistical tests must be interpreted with caution!|Chi-squared|||||4.792|0.039|0.57
73998527|NCT02285153|147545376|SUPERIORITY|||||||0.057|||||||Chi-squared|||||||0.057
73998528|NCT02285153|147545377|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
73998529|NCT02285153|147545378|SUPERIORITY|||||||0.467|||||||Chi-squared|||||||0.467
73998530|NCT00548262|147545379|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Success at EOT||73.6|44.6|
73998531|NCT00548262|147545380|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|EIVT Success||73.6|44.6|
73998532|NCT00548262|147545380|SUPERIORITY_OR_OTHER||percentage of participants with success|47.7|||||TWO_SIDED|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Week 2 Follow-up Success||62.5|33.0|
73998533|NCT00548262|147545381|SUPERIORITY_OR_OTHER||percentage of participants with success|52.4|||||TWO_SIDED|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||73.7|31.0|
73998534|NCT00548262|147545381|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|0.0|100.0|||||95% CI based on normal approximation to the binomial.|Candida famata: Success||100.0|0.0|
73998535|NCT00548262|147545381|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success||100.0|13.3|
73998536|NCT00548262|147545381|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
73998537|NCT00548262|147545381|SUPERIORITY_OR_OTHER||percentage of participants with success|16.7|||||TWO_SIDED|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success||46.5|0.0|
74036463|NCT01627067|147626107|NON_INFERIORITY|The study terminated early due to lack of efficacy and funds only 22 patients were enrolled in the study. With 40 patients accrued at a rate of 2 patients per month, a one-sided alpha of 5%, and a post- accrual follow up of 3 months, we would have 80% power to detect a median PFS of 12 months as being statistically significantly higher than a historical control median PFS of 7 months.|Cox Proportional Hazard|0.25||||0.015|TWO_SIDED|95.0|0.08|0.76|||Regression, Cox|||Data for PFS were censored at the time of a patient's removal from study. With 40 patients accrued at a rate of 2 patients per month, a one-sided alpha of 5%, and a post- accrual follow up of 3 months, we would have 80% power to detect a median PFS of 12 months as being statistically significantly higher than a historical control median PFS of 7 months. The study terminated early due to lack of efficacy and funds only 22 patients were enrolled in the study.||0.76|0.08|0.015
74036464|NCT01627067|147626110|OTHER||Hazard Ratio (HR)|0.6||||0.31|TWO_SIDED|95.0|0.22|1.62|||Regression, Cox|||||1.62|0.22|0.31
73998538|NCT00548262|147545381|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||100.0|55.2|
73998539|NCT00548262|147545381|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||93.8|20.5|
73998540|NCT00548262|147545382|SUPERIORITY_OR_OTHER||percentage of participants with success|52.4|||||TWO_SIDED|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||73.7|31.0|
73998541|NCT00548262|147545382|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success||100.0|13.3|
73998542|NCT00548262|147545382|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
73998543|NCT00548262|147545382|SUPERIORITY_OR_OTHER||percentage of participants with success|16.7|||||TWO_SIDED|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success||46.5|0.0|
73998544|NCT00548262|147545382|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||100.0|55.2|
73998545|NCT00548262|147545382|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||93.8|20.5|
73998546|NCT00548262|147545383|SUPERIORITY_OR_OTHER||percentage of participants with success|47.6|||||TWO_SIDED|95.0|26.3|69.0|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||69.0|26.3|
73998547|NCT00548262|147545383|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
73998548|NCT00548262|147545383|SUPERIORITY_OR_OTHER||percentage of participants with success|70.0|||||TWO_SIDED|95.0|41.6|98.4|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||98.4|41.6|
73998549|NCT00548262|147545383|SUPERIORITY_OR_OTHER||percentage of participants with success|28.6|||||TWO_SIDED|95.0|0.0|62.0|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||62.0|0.0|
73998550|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|56.3|||||TWO_SIDED|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||73.4|39.1|
73998551|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||93.3|40.0|
73998552|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|54.5|||||TWO_SIDED|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||71.5|37.6|
73998553|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
73998554|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|56.4|||||TWO_SIDED|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||72.0|40.8|
73998555|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||100.0|44.9|
73998556|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|55.3|||||TWO_SIDED|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||71.1|39.5|
73998557|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|83.3|||||TWO_SIDED|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||100.0|53.5|
73998558|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|38.5|||||TWO_SIDED|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||64.9|12.0|
73998559|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|67.7|||||TWO_SIDED|95.0|51.3|84.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||84.2|51.3|
73998560|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||79.5|6.2|
73998561|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||77.8|46.5|
73998562|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|57.9|||||TWO_SIDED|95.0|35.7|80.1|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||80.1|35.7|
73998563|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|60.0|||||TWO_SIDED|95.0|40.8|79.2|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||79.2|40.8|
73998564|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||73.6|44.6|
73998565|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||79.5|6.2|
73998566|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||77.8|46.5|
73998567|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|58.1|||||TWO_SIDED|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||72.9|43.4|
73998568|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|20.0|||||TWO_SIDED|95.0|0.0|55.1|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||55.1|0.0|
73998569|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|64.1|||||TWO_SIDED|95.0|49.0|79.2|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||79.2|49.0|
73998570|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|21.7|78.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||78.3|21.7|
73998571|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|62.5|||||TWO_SIDED|95.0|45.7|79.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||79.3|45.7|
73998572|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
73998573|NCT00548262|147545384|SUPERIORITY_OR_OTHER||percentage of participants with success|62.1|||||TWO_SIDED|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||79.7|44.4|
73998574|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|56.3|||||TWO_SIDED|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||73.4|39.1|
73998575|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||93.3|40.0|
73998576|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|54.5|||||TWO_SIDED|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||71.5|37.6|
73998577|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
73998578|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|56.4|||||TWO_SIDED|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||72.0|40.8|
73998579|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||100.0|44.9|
73998580|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|55.3|||||TWO_SIDED|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||71.1|39.5|
73998581|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|83.3|||||TWO_SIDED|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||100.0|53.5|
73998582|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|46.2|||||TWO_SIDED|95.0|19.1|73.3|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||73.3|19.1|
73998583|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|64.5|||||TWO_SIDED|95.0|47.7|81.4|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||81.4|47.7|
73998584|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||79.5|6.2|
73998585|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||77.8|46.5|
73998586|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|63.2|||||TWO_SIDED|95.0|41.5|84.8|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||84.8|41.5|
73998587|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|56.0|||||TWO_SIDED|95.0|36.5|75.5|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||75.5|36.5|
73998588|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||73.6|44.6|
73998589|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||79.5|6.2|
73998590|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||77.8|46.5|
73998591|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|58.1|||||TWO_SIDED|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||72.9|43.4|
73998592|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||82.9|0.0|
73998593|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|61.5|||||TWO_SIDED|95.0|46.3|76.8|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||76.8|46.3|
73998594|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|58.3|||||TWO_SIDED|95.0|30.4|86.2|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||86.2|30.4|
73998595|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|59.4|||||TWO_SIDED|95.0|42.4|76.4|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||76.4|42.4|
73998596|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
73998597|NCT00548262|147545385|SUPERIORITY_OR_OTHER||percentage of participants with success|62.1|||||TWO_SIDED|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||79.7|44.4|
73998598|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|37.5|||||TWO_SIDED|95.0|20.7|54.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||54.3|20.7|
73998599|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|75.0|||||TWO_SIDED|95.0|50.5|99.5|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||99.5|50.5|
73998600|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|39.4|||||TWO_SIDED|95.0|22.7|56.1|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||56.1|22.7|
73998601|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
73998602|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|48.7|||||TWO_SIDED|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||64.4|33.0|
73998603|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||82.9|0.0|
73998604|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|47.4|||||TWO_SIDED|95.0|31.5|63.2|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||63.2|31.5|
73998605|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|10.0|90.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||90.0|10.0|
73998606|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|38.5|||||TWO_SIDED|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||64.9|12.0|
73998607|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|51.6|||||TWO_SIDED|95.0|34.0|69.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||69.2|34.0|
73998608|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|14.3|||||TWO_SIDED|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||40.2|0.0|
73998609|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|54.1|||||TWO_SIDED|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||70.1|38.0|
73998610|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|42.1|||||TWO_SIDED|95.0|19.9|64.3|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||64.3|19.9|
73998611|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|52.0|||||TWO_SIDED|95.0|32.4|71.6|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||71.6|32.4|
73998612|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|47.7|||||TWO_SIDED|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||62.5|33.0|
73998613|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|14.3|||||TWO_SIDED|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||40.2|0.0|
73998614|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|54.1|||||TWO_SIDED|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||70.1|38.0|
73998615|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|46.5|||||TWO_SIDED|95.0|31.6|61.4|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||61.4|31.6|
73998616|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||82.9|0.0|
73998617|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|48.7|||||TWO_SIDED|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||64.4|33.0|
73998618|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|41.7|||||TWO_SIDED|95.0|13.8|69.6|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||69.6|13.8|
73998619|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|32.7|67.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||67.3|32.7|
73998620|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
73998621|NCT00548262|147545386|SUPERIORITY_OR_OTHER||percentage of participants with success|51.7|||||TWO_SIDED|95.0|33.5|69.9|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||69.9|33.5|
73998622|NCT00548262|147545387|SUPERIORITY_OR_OTHER||percentage of participants with success|68.6|||||TWO_SIDED|95.0|53.2|84.0|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (EIVT): Success||84.0|53.2|
73998623|NCT00548262|147545387|SUPERIORITY_OR_OTHER||percentage of participants with success|22.2|||||TWO_SIDED|95.0|0.0|49.4|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EIVT): Success||49.4|0.0|
73998624|NCT00548262|147545387|SUPERIORITY_OR_OTHER||percentage of participants with success|71.4|||||TWO_SIDED|95.0|56.5|86.4|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (EOT): Success||86.4|56.5|
73998625|NCT00548262|147545387|SUPERIORITY_OR_OTHER||percentage of participants with success|11.1|||||TWO_SIDED|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EOT): Success||31.6|0.0|
73998626|NCT00548262|147545387|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|40.7|73.5|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (Week 2 F/U): Success||73.5|40.7|
73998627|NCT00548262|147545387|SUPERIORITY_OR_OTHER||percentage of participants with success|11.1|||||TWO_SIDED|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (Week 2 F/U): Success||31.6|0.0|
73998628|NCT03592745|147545431|EQUIVALENCE|Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|32.0||||0.002|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median absolute change in bicep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.002
73998629|NCT03592745|147545431|EQUIVALENCE|Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|87.0||||0.445|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median absolute change in tricep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.445
73998630|NCT03592745|147545431|EQUIVALENCE|Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|95.0||||0.678|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in bicep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.678
73998631|NCT03592745|147545431|EQUIVALENCE|Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|98.0||||0.777|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in tricep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.777
73998632|NCT03592745|147545432|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 3 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|112.0||||1|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||1.000
73998633|NCT03592745|147545432|EQUIVALENCE|Statistical analysis of median change from baseline to week 16 (3 month follow-up) was assessed with the Upper Extremity Fugl Meyer score in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median change in Upper Extremity Fugl Meyer score between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|110.5||||0.95|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.950
74008613|NCT01572675|147567220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||Fisher Exact|||Group comparsion (Arcoxia® vs Celebrex®) for previous treatment with other agents prior to initiation of Arcoxia® and Celebrex® for the main study indications||||0.049
74008614|NCT01572675|147567223|SUPERIORITY_OR_OTHER_LEGACY|||||||0.165|||||||Chi-squared|||Group comparsion (Arcoxia® vs Celebrex®) of adverse events experienced during treatment||||0.165
74008615|NCT00053703|147567225|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
74036465|NCT00926796|147626112|SUPERIORITY_OR_OTHER||Proportion of cured participants|100.0|||<|0.05|ONE_SIDED|95.0|98.53||||Exact binomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is \<95% is rejected.|When the lower 95% confidence limit is \>=95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly \>=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is \<95%.|||98.53|<0.05
74036466|NCT00926796|147626119|SUPERIORITY_OR_OTHER||Proportion of cured participants|99.5|||<|0.05|ONE_SIDED|95.0|97.64||||Exact bionomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is \<95% is rejected.|When the lower 95% confidence interval is above 95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly \>=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is \<95%.|||97.64|<0.05
74036467|NCT01628016|147626121|OTHER||Mean Difference (Final Values)|3.98||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
74036468|NCT01341652|147626123|OTHER|||||||0.97|||||||Mantel Haenszel|||||||0.97
74036469|NCT01341652|147626124|SUPERIORITY|||||||0.08|||||||Wilcoxon Rank Sum test|||||||.08
74036470|NCT01341652|147626126|OTHER||Hazard Ratio (HR)|1.6||||0.14|TWO_SIDED|95.0|0.9|2.8|||Regression, Cox|||||2.8|0.9|0.14
74036471|NCT00127062|147626175|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74036472|NCT00127062|147626175|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73876988|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|35.7||||0.183|TWO_SIDED|95.0|1.8|69.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||69.7|1.8|0.183
73876989|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||50.3|-12.8|0.257
73998634|NCT00738894|147545433|SUPERIORITY|This is the first of two primary outcomes for this study. Assumptions for power calculations: expected event free for medical management 92% at 24 months; expected event free for device closure 96.4% at 24 months (55% risk reduction); 664 subjects randomly assigned 2:1 to device closure or medical management provides 80% power with 15% attrition (over 5 years) and 1-sided alpha = 0.024 to allow for interim analysis (interim analysis later rescinded from plan).|Hazard Ratio (HR)|0.23||||0.001|TWO_SIDED|95.0|0.09|0.62||1-sided p-value was adjusted for multiplicity with 2nd primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|Log Rank||Hazard ratio (test/control) obtained from Cox proportional hazards model with treatment arm as sole explanatory variable, the exponentiated coefficient of which provided the hazard ratio. Unadjusted for multiplicity.|"Test null hypothesis of equal or lower recurrent stroke-free survivorship for device closure compared to medical management.~H0: Sd(t) ≤ Sm(t) for all t, versus H1: Sd(t) \> Sm(t) for all t, where Sd(t) and Sm(t) are true Kaplan-Meier product-limit survivor functions for the device closure and medical management arms and t is time from randomization to event or censoring.~Event-free subjects were censored at time of last follow-up. Significance threshold (1-sided alpha) = 0.025."||0.62|0.09|0.001
74008616|NCT00705432|147567269|SUPERIORITY_OR_OTHER||The difference in SVR|26.6|||<|0.0001|TWO_SIDED|95.0|19.1|34.1|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for for baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||34.1|19.1|<0.0001
74008617|NCT00705432|147567269|SUPERIORITY_OR_OTHER||The difference in SVR|28.3|||<|0.0001|TWO_SIDED|95.0|20.8|35.8|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||35.8|20.8|<0.0001
74008618|NCT00705432|147567269|SUPERIORITY_OR_OTHER||The difference in SVR|19.2||||0.044|TWO_SIDED|95.0|1.6|36.9|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||36.9|1.6|0.0440
74008619|NCT00705432|147567269|SUPERIORITY_OR_OTHER||The difference in SVR|29.7||||0.0035|TWO_SIDED|95.0|12.2|47.1|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||47.1|12.2|0.0035
74008620|NCT00705432|147567270|SUPERIORITY_OR_OTHER||The difference in SVR rates|27.5|||<|0.0001|TWO_SIDED|95.0|19.2|35.2|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||35.2|19.2|<0.0001
74008621|NCT00705432|147567270|SUPERIORITY_OR_OTHER||The difference in SVR rates|29.1|||<|0.0001|TWO_SIDED|95.0|21.5|36.8|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||36.8|21.5|<0.0001
74008622|NCT00705432|147567270|SUPERIORITY_OR_OTHER||The difference in SVR|21.3||||0.0366|TWO_SIDED|95.0|2.3|40.2|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||40.2|2.3|0.0366
74008623|NCT00705432|147567270|SUPERIORITY_OR_OTHER||The difference in SVR|27.2||||0.0107|TWO_SIDED|95.0|9.0|45.3|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||45.3|9.0|0.0107
74008624|NCT01353079|147567279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.834|||<|0.05|TWO_SIDED|95.0|-1.298|-0.369|||ANCOVA|||||-0.369|-1.298|<0.05
74008625|NCT01353079|147567280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.857|||<|0.05|TWO_SIDED|95.0|-1.388|-0.326|||ANCOVA|||||-0.326|-1.388|<0.05
74008626|NCT01353079|147567281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.771|||<|0.05|TWO_SIDED|95.0|-1.213|-0.329|||ANCOVA|||||-0.329|-1.213|<0.05
74008627|NCT01353079|147567282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.788|||<|0.05|TWO_SIDED|95.0|-1.291|-0.284|||ANCOVA|||||-0.284|-1.291|<0.05
74008628|NCT02347488|147567283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|1.8|<|0.001|TWO_SIDED|95.0|2.88|3.32|||ANCOVA|||Average displacement difference in cm, tape vs. tube-holder. 17 participants was the estimated enrollment needed to detect a difference of 1 SD from the mean between the 2 fixation techniques at 80% power; additional enrollment was included to increase the power of results and to include a larger variety of patients undergoing different surgical procedures.||3.32|2.88|<0.001
74008629|NCT02281357|147567287|SUPERIORITY|The null hypothesis was that the average percentage change in OCS dose on tralokinumab was equal to the average percentage change in OCS dose on placebo.|LS Mean difference|-7.78||||0.271|TWO_SIDED|95.0|-21.7|6.15|||ANCOVA|The analysis of covariance (ANCOVA) model utilised a sandwich estimator for the variance.|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate. No interaction terms were included in the model. All group comparisons from the ANCOVA model were based on Type III sums of squares.|Comparison of percent change from baseline in OCS dose: tralokinumab vs placebo.||6.15|-21.70|0.271
74008630|NCT02281357|147567288|SUPERIORITY||Odds Ratio (OR)|1.33||||0.442|TWO_SIDED|95.0|0.65|2.73|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of OCS dose ≤5.0 mg: tralokinumab vs placebo.||2.73|0.65|0.442
73998635|NCT00738894|147545434|SUPERIORITY|This is the second of two primary outcomes for this study. Assumptions for power calculations: expected proportion of brain infarct is 3-7 times the clinical stroke rate; expected brain infarct proportion for medical management 14.5% (2.9% clinical stroke x 5); expected brain infarct for device closure 6.5% (55% risk reduction); 597 subjects (10% attrition from 664) provides 73% power with 1-sided alpha = 0.0125 (based conservatively on a Bonferroni adjustment of alpha/2).|Risk Difference (RD)|0.056||||0.024|TWO_SIDED|95.0|0.003|0.108||1-sided p-value was adjusted for multiplicity with 1st primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|z-test, 1-sided||Unadjusted for multiplicity.|"Test null hypothesis of equal or higher proportion with brain infarct for device closure compared to medical management.~H0: Pm - Pd ≤ 0, versus H1: Pm - Pd \> 0, where Pd and Pm are true proportions of subjects with brain infarct for the device closure and medical management arms.~Significance threshold (1-sided alpha) = 0.025."||0.108|0.003|0.024
73998636|NCT00719329|147545447|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.75|||||TWO_SIDED|95.0|0.7|0.81|||Binomial Regression, Log Link|General Estimating Equations (GEE) to account for clustered allocation|Prevalence Rate Ratio - Comparing Single CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.81|0.70|
73998637|NCT00719329|147545447|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.71|||||TWO_SIDED|95.0|0.66|0.77|||Binomial Regression, Log Link|General Estimating Equations (GEE) to account for clustered allocation|Prevalence Rate Ratio - Comparing Multiple CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.77|0.66|
73998638|NCT00719329|147545448|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.78|||||TWO_SIDED|95.0|0.74|0.82|||Binomial Regression, Log Link|Generalized Estimating Equations to account for clustered allocation|Prevalence Ratio Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.82|0.74|
73998639|NCT00719329|147545448|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.61|||||TWO_SIDED|95.0|0.57|0.65|||Binomial Regression, Log Link|Generalized Estimating Equations to account for clustered allocation|Prevalence Rate Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.65|0.57|
73998640|NCT00719329|147545449|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.92|||||TWO_SIDED|95.0|0.89|0.96|||Binomial Regression, Log Link|General Estimating Equations to adjust for clustered allocation|Prevalence Rate Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.96|0.89|
73998641|NCT00719329|147545449|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.57|||||TWO_SIDED|95.0|0.53|0.63|||Binomial Regression, Log Link|General Estimating Equations to account for clustered allocation|Prevalence Ratio Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.63|0.53|
73998642|NCT02186600|147545493|OTHER|Hierarchical linear modeling for intent-to-treat analysis to analyze time X group interactions, adjusted for baseline total body lean mass and height.||||||0.7|||||||hierarchical linear modeling|controlled for total lean mass and height||||||0.7
73998643|NCT02186600|147545494|OTHER|hierarchical linear modeling||||||0.01|||||||hierarchical linear modeling|||||||0.01
73998644|NCT02186600|147545495|OTHER|Hierarchical linear modeling|||||<|0.007|||||||hierarchical linear modeling|||||||<0.007
73998645|NCT03026075|147545496|SUPERIORITY||||||<|0.01|||||||McNemar|||"The primary objective of the study is to evaluate the effectiveness of MCS in cleansing a poorly prepared colon.~A sample size of 47 patients is required as per a McNemar test to determine that the paired discordant proportions are significantly different under the followings assumptions:~Probability of Type I Error (α) = 0.05, Power (1 - β) = 0.8 Proportion switching from + to - = 0, Proportion switching from - to + = 0.6 Potential of dropout 10% (i.e. 4 cases)"||||<0.01
73998646|NCT00293059|147545501|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||inverting 2 one-sided tests|||||||< 0.0001
73998647|NCT00728910|147545644|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis was that the sequential addition of a fibrate and niacin to baseline atorvastatin therapy would not have any effect on apo-AI catabolism.||||>0.5
74036473|NCT04146467|147626180|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74036474|NCT04146467|147626182|SUPERIORITY||||||<|0.0004|||||||Fisher Exact|||||||<0.0004
74036475|NCT04146467|147626190|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74036476|NCT03731364|147626202|SUPERIORITY|||||||0.276|||||||ANOVA|||||||0.276
74036477|NCT03731364|147626202|SUPERIORITY|||||||0.651|||||||ANOVA|||||||0.651
73998648|NCT00728910|147545645|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on apo-A1 production rates||||>0.5
73998649|NCT00728910|147545646|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on post-prandial triglyceride levels following an oral fat load||||<0.0005
73998650|NCT00728910|147545646|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0005
73998651|NCT01241604|147545662|EQUIVALENCE|Equivalent non-parametric tests||||||0.753|||||||Wilcoxon signed ranks test|||||||.753
73998652|NCT01209234|147545683|SUPERIORITY||Cox Proportional Hazard|0.7|STANDARD_ERROR_OF_MEAN|0.024||0.026|TWO_SIDED|95.0|0.52|0.96|||Regression, Cox||This is the estimated standard error of the log hazard ratio|||0.96|0.52|0.026
73998653|NCT01209234|147545684|SUPERIORITY||Cox Proportional Hazard|0.84|STANDARD_ERROR_OF_MEAN|0.009||0.061|TWO_SIDED|95.0|0.7|1.01||Not adjusted for multiple comparisons|Regression, Cox||CDC-defined all-cause infection secondary outcome This is the estimated standard error of the log hazard ratio|||1.01|0.70|0.061
73998654|NCT01209234|147545684|SUPERIORITY||Cox Proportional Hazard|0.83|STANDARD_ERROR_OF_MEAN|0.008||0.035|TWO_SIDED|95.0|0.7|0.99||Not adjusted for multiple comparisons|Regression, Cox||Clinical criteria for all-cause infection This is the estimated standard error of the log hazard ratio|||0.99|0.70|0.035
73998655|NCT03973931|147545689|NON_INFERIORITY|Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure of the 12 observations|||||<|0.05|||||||GEE|To account for multiple treatment comparisons significance levels of 0.05/3||||||<0.05
74036478|NCT03731364|147626202|SUPERIORITY|||||||0.556|||||||ANOVA|||||||0.556
74036479|NCT03731364|147626203|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
74036480|NCT03731364|147626203|SUPERIORITY|||||||0.649|||||||Wilcoxon (Mann-Whitney)|||||||0.649
74036481|NCT03731364|147626203|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||||||0.608
73956736|NCT01018511|147449441|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.009|TWO_SIDED|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.1|-0.9|0.009
74036482|NCT03731364|147626204|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic|Not estimable|Not estimable|Not estimable||||0
74036483|NCT03731364|147626204|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic|Not estimable|Not estimable|Not estimable||||0
73956737|NCT01018511|147449441|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.045|TWO_SIDED|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.0|-0.8|0.045
73956738|NCT01018511|147449441|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.4|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.7|-1.4|< 0.001
73956739|NCT01018511|147449441|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.1|-0.9|0.011
73956740|NCT01018511|147449441|SUPERIORITY_OR_OTHER_LEGACY||Least squares men difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.3|-0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.5|-1.3|< 0.001
73956741|NCT01018511|147449442|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|-0.5|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.1|-0.5|0.008
73956742|NCT01018511|147449442|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.021|TWO_SIDED|95.0|-0.4|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.0|-0.4|0.021
73956743|NCT01018511|147449442|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.6|< 0.001
73956744|NCT01018511|147449442|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.6|< 0.001
73956745|NCT01018511|147449442|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.139|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.3|0.139
73956746|NCT01018511|147449444|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.14||0.068|TWO_SIDED|95.0|-4.3|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-4.3|0.068
73956747|NCT01018511|147449444|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.7|STANDARD_DEVIATION|1.15||0.02|TWO_SIDED|95.0|-4.9|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.4|-4.9|0.020
73956748|NCT01018511|147449444|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-2.5|-6.9|< 0.001
73956749|NCT01018511|147449444|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-7.5|-3.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||-3.1|-7.5|< 0.001
73956750|NCT01018511|147449444|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.14||0.022|TWO_SIDED|95.0|-4.8|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.4|-4.8|0.022
73956751|NCT01018511|147449445|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.0|STANDARD_ERROR_OF_MEAN|1.16||0.011|TWO_SIDED|95.0|0.7|5.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.||5.2|0.7|0.011
73956752|NCT01018511|147449445|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|1.17||0.035|TWO_SIDED|95.0|0.2|4.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.8|0.2|0.035
73956753|NCT01018511|147449445|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|2.8|7.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||7.3|2.8|< 0.001
73876990|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-5.6||||1|TWO_SIDED|95.0|-44.7|33.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||33.6|-44.7|1.000
73876991|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|33.3||||0.307|TWO_SIDED|95.0|-9.7|76.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||76.3|-9.7|0.307
73876992|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|33.3||||0.172|TWO_SIDED|95.0|-4.1|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-4.1|0.172
73876993|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||55.1|-40.9|1.000
73876994|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-27.8|54.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||54.5|-27.8|1.000
73876995|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-11.7||||0.675|TWO_SIDED|95.0|-51.5|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.1|-51.5|0.675
73998656|NCT03973931|147545690|NON_INFERIORITY|Analysis of the longitudinal data (12 observations per patient) and estimated absolute differences in PDC between treatment group and usual care was analyzed using Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure was used.|||||<|0.05||||||To account for multiple treatment comparisons significance levels of 0.05/3, and if any test was significant, a significance level of (R/3)\*(0.05/3) using the Holm method was used for the 3 pairwise comparisons, R=number of significant stage 1 tests.|GEE|||||||<0.05
73998657|NCT00925353|147545694|SUPERIORITY_OR_OTHER||Actual lab results shown|1.0|||<|0.05||95.0|||||non-compartmental pharmacokinetic|The planned analysis was to estimate pharmacokinetic parameters. There were too few detectable values to be able to perform this analysis.||Null Hypothesis: Application of 4% lidocaine gel on the breasts and chest wall of healthy women occluded for one hour does not result in systemically toxic plasma concentrations of lidocaine or its principal metabolite, monoethylglycinexyliidie (MEGX), electrocardiogram changes, or adverse events.||||<0.05
73998658|NCT03507777|147545699|SUPERIORITY||||||<|0.0001|||||||Linear mixed model|||||||<0.0001
74036484|NCT03731364|147626204|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic||Not estimable|Not estimable||||0
73876996|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-12.9||||0.644|TWO_SIDED|95.0|-59.2|33.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||33.5|-59.2|0.644
73998659|NCT03507777|147545700|SUPERIORITY|||||||0.2487|||||||A Cox regression model|||||||0.2487
73998660|NCT03507777|147545701|SUPERIORITY|||||||0.2952|||||||A Cox regression model|||||||0.2952
73998661|NCT00006011|147545741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||"Primary outcome is measured as a treatment hazard ratio stratified by stage and assuming proportional hazards.~Recurrence-free survival hazard ratio: Arm 2 is relative to Arm 1."||1.17|0.69|
73998662|NCT03484273|147545751|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated Measures ANOVA||Repeated Measured ANOVA was used to compare the 4 compression garment configurations.||||<0.001
73998663|NCT03484273|147545752|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
73998664|NCT03484273|147545753|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
73998665|NCT03484273|147545754|SUPERIORITY|||||||0.01|||||||Repeated Measures ANOVA|||||||0.01
73998666|NCT03484273|147545755|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
73998667|NCT03484273|147545756|SUPERIORITY|||||||0.001|||||||Repeated Measures ANOVA|||||||0.001
73998668|NCT03484273|147545757|SUPERIORITY|||||||0.04|||||||Repeated Measures ANOVA|||||||0.04
73998669|NCT01670760|147545766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69||||0.69|TWO_SIDED||||||ANOVA|||||||0.69
73998670|NCT00741390|147545779|SUPERIORITY_OR_OTHER||Percentage|99.59||||||95.0|98.09|99.59||||||||99.59|98.09|
73998671|NCT00741390|147545779|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|98.79|100.0||||||||100|98.79|
73998672|NCT00741390|147545779|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|97.61|100.0||||||||100|97.61|
73998673|NCT00741390|147545779|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|95.36|100.0||||||||100|95.36|
73998674|NCT00741390|147545779|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|95.13|100.0||||||||100|95.13|
73998675|NCT00741390|147545780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.84|||<|0.001||95.0|6.8|10.84|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||10.84|6.80|<0.001
73998676|NCT00741390|147545780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.55||||0.003||95.0|3.63|8.55|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||8.55|3.63|0.003
74036485|NCT03731364|147626205|SUPERIORITY|||||||0.306|||||||ANOVA|||||||0.306
74036486|NCT03731364|147626205|SUPERIORITY|||||||0.595|||||||ANOVA|||||||0.595
74036487|NCT03731364|147626205|SUPERIORITY|||||||0.242|||||||ANOVA|||||||0.242
74036488|NCT05291949|147626211|OTHER|Bland-Altman|Bias|0.3|||||TWO_SIDED||||||Bland-Altman||||Lower 95% Limit of agreement (LoA) value = -0.34 Upper 95% LoA = 0.94|||
73956754|NCT01018511|147449445|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.6|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|2.3|6.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.8|2.3|< 0.001
74039812|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.2997|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.2997
73956755|NCT01018511|147449445|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.16||0.068|TWO_SIDED|95.0|-0.2|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.4|-0.2|0.068
73956756|NCT01018511|147449446|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.07||0.013|TWO_SIDED|95.0|0.5|4.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.7|0.5|0.013
73956757|NCT01018511|147449446|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.2|STANDARD_ERROR_OF_MEAN|1.08||0.043|TWO_SIDED|95.0|0.1|4.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.3|0.1|0.043
73956758|NCT01018511|147449446|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|2.4|6.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.5|2.4|< 0.001
73956759|NCT01018511|147449446|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|1.9|6.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.1|1.9|< 0.001
73956760|NCT01018511|147449446|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.8|STANDARD_ERROR_OF_MEAN|1.06||0.092|TWO_SIDED|95.0|-0.3|3.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||3.9|-0.3|0.092
73956761|NCT01018511|147449447|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.1|STANDARD_ERROR_OF_MEAN|1.21||0.011|TWO_SIDED|95.0|0.7|5.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||5.5|0.7|0.011
73956762|NCT01018511|147449447|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|1.23||0.314|TWO_SIDED|95.0|-1.2|3.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.6|-1.2|0.314
73956763|NCT01018511|147449447|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.6|STANDARD_ERROR_OF_MEAN|1.19||0.003|TWO_SIDED|95.0|1.2|5.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.9|1.2|0.003
73956764|NCT01018511|147449447|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|1.21||0.161|TWO_SIDED|95.0|-0.7|4.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.1|-0.7|0.161
73956765|NCT01018511|147449447|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|1.21||0.708|TWO_SIDED|95.0|-1.9|2.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||2.8|-1.9|0.708
73998677|NCT00741390|147545780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.46||95.0|-3.57|0.23|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||0.23|-3.57|0.460
73998678|NCT00741390|147545781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.9||||0.017||95.0|1.14|4.9|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||4.90|1.14|0.017
73998679|NCT00741390|147545782|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.001
73998680|NCT00741390|147545782|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.002
73998681|NCT00741390|147545782|SUPERIORITY_OR_OTHER|||||||0.761||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.761
73876997|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-50.6|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.6|-50.6|1.000
73876998|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-33.4|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.0|-33.4|1.000
73998682|NCT00741390|147545782|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.004
73998683|NCT00620282|147545783|SUPERIORITY_OR_OTHER||Least squares mean|7.43||||0.0549||95.0|-0.164|15.025||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||15.025|-0.164|0.0549
73998684|NCT00620282|147545783|SUPERIORITY_OR_OTHER||Least squares mean|2.08||||0.5681||95.0|-5.215|9.375||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||9.375|-5.215|0.5681
73998685|NCT00620282|147545783|SUPERIORITY_OR_OTHER||Least squares mean|5.35||||0.1668||95.0|-2.323|13.024||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||13.024|-2.323|0.1668
73998686|NCT00620282|147545784|SUPERIORITY_OR_OTHER||Least squares mean|4.499||||0.2648||95.0|-3.535|12.534||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||12.534|-3.535|0.2648
73998687|NCT00620282|147545784|SUPERIORITY_OR_OTHER||Least squares mean|0.709||||0.8518||95.0|-6.904|8.322||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||8.322|-6.904|0.8518
73998688|NCT00620282|147545784|SUPERIORITY_OR_OTHER||Least squares mean|3.79||||0.3435||95.0|-4.194|11.774||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||11.774|-4.194|0.3435
74090602|NCT04295135|147734726|SUPERIORITY||Median Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.003|>|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||>0.05
73876999|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||55.1|-40.9|1.000
73998689|NCT00620282|147545785|SUPERIORITY_OR_OTHER||Least squares mean|-0.536||||0.0023||95.0|-0.868|-0.203||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||-0.203|-0.868|0.0023
73998690|NCT00620282|147545785|SUPERIORITY_OR_OTHER||Least squares mean|-0.077||||0.6207||95.0|-0.391|0.236||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||0.236|-0.391|0.6207
74090603|NCT01517659|147734730|OTHER||Mean Difference (Final Values)|2.61|STANDARD_DEVIATION|2.29|||TWO_SIDED|95.0|2.23|3.27||||||||3.27|2.23|
73998691|NCT00620282|147545785|SUPERIORITY_OR_OTHER||Least squares mean|-0.458||||0.0098||95.0|-0.8|-0.116||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||-0.116|-0.8|0.0098
73998692|NCT00620282|147545786|SUPERIORITY_OR_OTHER||Least squares mean|-35.605||||||95.0|-46.797|-24.413||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||-24.413|-46.797|
73998693|NCT00620282|147545786|SUPERIORITY_OR_OTHER||Least squares mean|-9.653||||0.0677||95.0|-20.041|0.736||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||0.736|-20.041|0.0677
74008631|NCT02281357|147567289|SUPERIORITY||Odds Ratio (OR)|1.38||||0.356|TWO_SIDED|95.0|0.7|2.74|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of ≥50% reduction in OCS dose: tralokinumab vs placebo.||2.74|0.70|0.356
74008632|NCT02281357|147567290|SUPERIORITY||Rate Ratio|0.8||||0.186|TWO_SIDED|95.0|0.57|1.12|||Negative binomial||Treatment group, OCS dose at baseline, and number of exacerbations in the previous year are included in the model as covariates.|Comparison of AAER: tralokinumab vs placebo.||1.12|0.57|0.186
74090604|NCT03835325|147734738|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The sample size calculation was based on the following hypothesis test:~H0: there is no improvement in memory capacity between the initial (VS) and final (VF) assessments, assessed by the self-efficacy factor of the MIAr questionnaire.~H1: there is an improvement in memory capacity between the initial (VS) and final (VF) assessments, assessed by the self-efficacy factor of the MIAr questionnaire.~or H0: AUTO-EF (VF) - AUTO-EF (VS) ≤ 0 H1: AUTO-EF (VF) - AUTO-EF (VS)\> 0"||||<0.001
74090605|NCT03212794|147734753|SUPERIORITY||||||=|0.87||||||Threshold for significance p\<0.05|Chi-squared|||||||=0.87
74090606|NCT03212794|147734754|SUPERIORITY||||||=|0.82||||||Threshold for significance p\<0.05|Chi-squared|||||||=0.82
74090607|NCT03212794|147734755|OTHER||||||=|0.92||||||Threshold for significance p\<0.05|Log Rank|If no event occurred, the data from those individuals were right censored.||||||=0.92
73998694|NCT00620282|147545786|SUPERIORITY_OR_OTHER||Least squares mean|-25.952||||||95.0|-37.429|-14.475||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||-14.475|-37.429|
73998695|NCT00620282|147545787|SUPERIORITY_OR_OTHER||Least squares mean|-11.871||||0.4121||95.0|-40.943|17.201||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||17.201|-40.943|0.4121
73998696|NCT00620282|147545787|SUPERIORITY_OR_OTHER||Least squares mean|3.815||||0.7622||95.0|-21.618|29.247||2-sided significance level of 5%|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||29.247|-21.618|0.7622
73998697|NCT00620282|147545787|SUPERIORITY_OR_OTHER||Least squares mean|-15.686||||0.2651||95.0|-43.838|12.466||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||12.466|-43.838|0.2651
73998698|NCT00620282|147545788|SUPERIORITY_OR_OTHER||Least squares mean|-1.528||||0.0268||95.0|-2.873|-0.184||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||-0.184|-2.873|0.0268
73998699|NCT00620282|147545788|SUPERIORITY_OR_OTHER||Least squares mean|-2.859||||||95.0|-4.139|-1.579||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||-1.579|-4.139|
73998700|NCT00620282|147545788|SUPERIORITY_OR_OTHER||Least squares mean|1.331||||0.0486||95.0|0.009|2.653||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||2.653|0.0090|0.0486
74090608|NCT03212794|147734756|OTHER||||||=|0.85||||||Threshold for significance p\<0.05|Log Rank|If no event occurred, the data from those individuals were right censored.||||||=0.85
73998701|NCT00620282|147545789|SUPERIORITY_OR_OTHER||Least squares mean|-2.237||||0.7736||95.0|-17.829|13.354||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||13.354|-17.829|0.7736
73998702|NCT00620282|147545789|SUPERIORITY_OR_OTHER||Least squares mean|1.912||||0.7993||95.0|-13.168|16.991||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||16.991|-13.168|0.7993
73998703|NCT00620282|147545789|SUPERIORITY_OR_OTHER||Least squares mean|-4.149||||0.5903||95.0|-19.582|11.284||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||11.284|-19.582|0.5903
73998704|NCT00620282|147545790|SUPERIORITY_OR_OTHER||Least squares mean|3.702||||0.5583||95.0|-8.96|16.365||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||16.365|-8.96|0.5583
73877000|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-50.6|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||50.6|-50.6|1.000
73998705|NCT00620282|147545790|SUPERIORITY_OR_OTHER||Least squares mean|2.773||||0.6517||95.0|-9.537|15.082||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||15.082|-9.537|0.6517
73998706|NCT00620282|147545790|SUPERIORITY_OR_OTHER||Least squares mean|0.929||||0.8822||95.0|-11.646|13.505||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||13.505|-11.646|0.8822
73998707|NCT00620282|147545791|SUPERIORITY_OR_OTHER||Least squares mean|-0.169||||0.9131||95.0|-3.273|2.935||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||2.935|-3.273|0.9131
73998708|NCT00620282|147545791|SUPERIORITY_OR_OTHER||Least squares mean|-0.723||||0.6362||95.0|-3.785|2.339||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||2.339|-3.785|0.6362
74090609|NCT00257920|147734818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.009||0.67||95.0|-0.023|0.015||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values \<= 0.050 were considered statistically significant.|Mixed Models Analysis|||The null hypothesis was that there is no difference in the mean calcium absorption fraction between Zemplar Injection and Hectorol Injection. The power calculation applied to the primary efficacy analysis.||0.015|-0.023|0.670
74090610|NCT00257920|147734819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.009||0.573||95.0|-0.024|0.014||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values \<=0.050 were considered statistically significant.|ANOVA|||The null hypothesis was that there is no difference in mean calcium absorption between Zemplar and Hectorol. Approximately 42 subjects were to be randomized assuming 36 subjects would available in the per-protocol set. A sample size of 36 subjects has 80% power to detect a mean difference of -0.018 assuming the Zemplar group mean is 0.139, the Hectorol group mean is 0.157 and the STD is 0.037. The ANOVA model included effects for sequence, subject-within-sequence, period and treatment regimen.||0.014|-0.024|0.573
74090611|NCT03508687|147734820|OTHER|||||||0.517||||||paired t test; baseline vs. week 12 (n = 5)|t-test, 2 sided|||||||0.517
74090612|NCT03508687|147734820|OTHER|||||||0.345|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Ranks Test (n = 5)||||||0.345
74090613|NCT00560937|147734846|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||T-test of change scores, pregnenolone vs. placebo post-treatment compared to baseline.||||.048
73877001|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-33.4|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||50.0|-33.4|1.000
73877002|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||55.1|-40.9|1.000
73877003|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-40.2|60.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||60.2|-40.2|1.000
73998709|NCT00620282|147545791|SUPERIORITY_OR_OTHER||Least squares mean|0.554||||0.7283||95.0|-2.643|3.751||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||3.751|-2.643|0.7283
73998710|NCT00620282|147545792|SUPERIORITY_OR_OTHER||Least squares mean|-36.709||||0.0694||95.0|-76.467|3.048||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||3.048|-76.467|0.0694
73998711|NCT00620282|147545792|SUPERIORITY_OR_OTHER||Least squares mean|-3.786||||0.844||95.0|-42.373|34.801||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||34.801|-42.373|0.844
73998712|NCT00620282|147545792|SUPERIORITY_OR_OTHER||Least squares mean|-32.923||||0.0994||95.0|-72.353|6.507||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||6.507|-72.353|0.0994
73998713|NCT00620282|147545793|SUPERIORITY_OR_OTHER||Least squares mean|-0.42||||0.2282||95.0|-1.118|0.278||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.278|-1.118|0.2282
73998714|NCT00620282|147545793|SUPERIORITY_OR_OTHER||Least squares mean|-0.018||||0.9569||95.0|-0.697|0.661||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.661|-0.697|0.9569
74090614|NCT00560937|147734847|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||t-test, 2 sided|||||||0.79
74090615|NCT00560937|147734848|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
74090616|NCT00560937|147734849|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||T-test of change scores, pregnenolone compared to placebo post-treatment vs. pre-randomization.||||1.0
73998715|NCT00620282|147545793|SUPERIORITY_OR_OTHER||Least squares mean|-0.402||||0.2465||95.0|-1.097|0.293||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.293|-1.097|0.2465
73998716|NCT01489891|147545878|NON_INFERIORITY_OR_EQUIVALENCE|Beta 0.1; Alpha 0.05|Median Difference (Final Values)|30.6|STANDARD_DEVIATION|42.1|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
73998717|NCT03001076|147545882|SUPERIORITY||Difference in LS mean|-28.45|STANDARD_ERROR_OF_MEAN|3.022|<|0.001|TWO_SIDED|95.0|-34.376|-22.531|||ANCOVA|||||-22.531|-34.376|<0.001
73998718|NCT03001076|147545883|SUPERIORITY||Difference in LS mean|-23.56|STANDARD_ERROR_OF_MEAN|2.777|<|0.001|TWO_SIDED|95.0|-29.005|-18.121|||ANCOVA|||||-18.121|-29.005|<0.001
74090617|NCT00560937|147734850|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
73998719|NCT03001076|147545884|SUPERIORITY||Difference in LS mean|-17.99|STANDARD_ERROR_OF_MEAN|2.018|<|0.001|TWO_SIDED|95.0|-21.94|-14.03|||ANCOVA|||||-14.030|-21.940|<0.001
73998720|NCT03001076|147545885|SUPERIORITY||Difference in LS mean|-19.32|STANDARD_ERROR_OF_MEAN|2.341|<|0.001|TWO_SIDED|95.0|-23.908|-14.732|||ANCOVA|||||-14.732|-23.908|<0.001
73877004|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|18.3||||0.392|TWO_SIDED|95.0|-22.9|59.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||59.6|-22.9|0.392
73998721|NCT03001076|147545886|SUPERIORITY||Location shift|-31.045|||<|0.001|TWO_SIDED|95.0|-44.761|-17.401|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-17.401|-44.761|<0.001
73998722|NCT03001076|147545887|SUPERIORITY||Difference in LS mean|-4.53|STANDARD_ERROR_OF_MEAN|5.24|=|0.388|TWO_SIDED|95.0|-14.877|5.812|||ANCOVA|||||5.812|-14.877|=0.388
73998723|NCT03001076|147545888|SUPERIORITY||Difference in LS mean|-5.89|STANDARD_ERROR_OF_MEAN|1.845|=|0.002|TWO_SIDED|95.0|-9.528|-2.25|||ANCOVA|||||-2.250|-9.528|=0.002
73998724|NCT03001076|147545890|SUPERIORITY||Difference in LS mean|-31.09|STANDARD_ERROR_OF_MEAN|2.238|<|0.001|TWO_SIDED|95.0|-35.498|-26.682|||ANCOVA|||Change from Baseline to Week 4||-26.682|-35.498|<0.001
73998725|NCT03001076|147545890|SUPERIORITY||Difference in LS mean|-29.12|STANDARD_ERROR_OF_MEAN|2.513|<|0.001|TWO_SIDED|95.0|-34.074|-24.168|||ANCOVA|||Change from Baseline to Week 8||-24.168|-34.074|<0.001
73998726|NCT03001076|147545891|SUPERIORITY||Difference in LS mean|-25.26|STANDARD_ERROR_OF_MEAN|2.004|<|0.001|TWO_SIDED|95.0|-29.204|-21.308|||ANCOVA|||Change from Baseline to Week 4||-21.308|-29.204|<0.001
73998727|NCT03001076|147545891|SUPERIORITY||Difference in LS mean|-23.75|STANDARD_ERROR_OF_MEAN|2.268|<|0.001|TWO_SIDED|95.0|-28.219|-19.276|||ANCOVA|||Change from Baseline to Week 8||-19.276|-28.219|<0.001
73998728|NCT03001076|147545892|SUPERIORITY||Difference in LS mean|-20.41|STANDARD_ERROR_OF_MEAN|1.513|<|0.001|TWO_SIDED|95.0|-23.39|-17.43|||ANCOVA|||Change from Baseline to Week 4||-17.430|-23.390|<0.001
73998729|NCT03001076|147545892|SUPERIORITY||Difference in LS mean|-18.46|STANDARD_ERROR_OF_MEAN|1.651|<|0.001|TWO_SIDED|95.0|-21.71|-15.206|||ANCOVA|||Change from Baseline to Week 8||-15.206|-21.710|<0.001
74090618|NCT02728752|147734872|SUPERIORITY||Mean Difference (Net)|-8.0|||<|0.0001|TWO_SIDED|95.0|-11.5|-4.6|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16 for Total Activity Score||-4.6|-11.5|<0.0001
73877005|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-44.7|50.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||50.5|-44.7|1.000
73998730|NCT03001076|147545893|SUPERIORITY||Difference in LS mean|-0.8|STANDARD_ERROR_OF_MEAN|4.99|=|0.873|TWO_SIDED|95.0|-10.663|9.059|||ANCOVA|||Change from Baseline to Week 4||9.059|-10.663|=0.873
73998731|NCT03001076|147545893|SUPERIORITY||Difference in LS mean|-0.08|STANDARD_ERROR_OF_MEAN|5.131|=|0.988|TWO_SIDED|95.0|-10.215|10.055|||ANCOVA|||Change from Baseline to Week 8||10.055|-10.215|=0.988
73998732|NCT03001076|147545894|SUPERIORITY||Difference in LS mean|-8.59|STANDARD_ERROR_OF_MEAN|1.619|<|0.001|TWO_SIDED|95.0|-11.778|-5.394|||ANCOVA|||Change from Baseline to Week 4||-5.394|-11.778|<0.001
73998733|NCT03001076|147545894|SUPERIORITY||Difference in LS mean|-6.42|STANDARD_ERROR_OF_MEAN|1.712|<|0.001|TWO_SIDED|95.0|-9.798|-3.049|||ANCOVA|||Change from Baseline to Week 8||-3.049|-9.798|<0.001
73998734|NCT00777088|147545924|NON_INFERIORITY|The cumulative rate of ipsilateral stroke or neurologic death is not ≥ 20% at 180-day clinical follow-up and the cumulative rate of ipsilateral stroke or neurovascular death is not ≥ 25% at 5-year clinical follow-up|||||<|0.001|||||||Bayesian|||||||<.001
74090619|NCT02728752|147734878|SUPERIORITY||Median Difference (Net)|8.6||||0.0001|TWO_SIDED|95.0|4.4|12.8|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||12.8|4.4|0.0001
73998735|NCT00777088|147545925|NON_INFERIORITY_OR_EQUIVALENCE|The rate of complete IA occlusion without major parent artery stenosis exceeds 50% with a posterior probability \>0.975.|||||<|0.001|||||||Bayesian|||||||<0.001
73998736|NCT02729831|147545934|SUPERIORITY||Mean Difference (Net)|9.0|||<|0.001|TWO_SIDED|95.0|6.0|12.0|||Regression, Linear|||The comparison groups were: Interactive decision versus Video decision aid.||12|6|<0.001
73998737|NCT02729831|147545935|SUPERIORITY||Odds Ratio (OR)|1.03||||0.86|TWO_SIDED|95.0|0.74|1.44|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups were: MD Usual Care vs. MD Provider report.||1.44|0.74|0.86
73998738|NCT02729831|147545935|SUPERIORITY||Odds Ratio (OR)|1.06||||0.75|TWO_SIDED|95.0|0.76|1.47|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups are: Interactive decision versus Video decision aid||1.47|0.76|0.75
73998739|NCT02729831|147545936|SUPERIORITY||Risk Difference (RD)|18.5|||<|0.001|TWO_SIDED|95.0|12.8|24.5|||Chi-squared|Compared patients who reported using all of the DA compared to everyone else.||Comparison groups were: patients who reported using all of the DA versus everyone else.||24.5|12.8|<0.001
73998740|NCT02729831|147545937|SUPERIORITY||Mean Difference (Net)|0.04|||<|0.001|TWO_SIDED|95.0|0.016|0.065|||Regression, Linear|Generalized Estimating Equation accounting for clustering within surgeons. Model included treatment, sex, age, education, site and joint.||We included all 4 study groups, but the comparison group was: informed, patient centered decision yes vs. no.||0.065|0.016|<0.001
73998741|NCT02729831|147545938|SUPERIORITY||Odds Ratio (OR)|25.7|||<|0.001|TWO_SIDED|95.0|16.5|40.1|||Regression, Logistic|General estimating equations were used to account for clustering of patients within surgeons.||We included all 4 study groups, but the comparison group was: informed, patient centered (IPC) decision yes vs. no. We excluded those who did not provide information to calculate the IPC variable.||40.1|16.5|<0.001
73998742|NCT01468181|147545960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|||<|0.001|TWO_SIDED|95.0|-1.87|-1.67|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 26 Weeks||-1.67|-1.87|<0.001
73877006|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|29.0||||0.07|TWO_SIDED|95.0|6.5|51.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||51.5|6.5|0.070
73877007|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|29.5||||0.007|TWO_SIDED|95.0|9.8|49.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||49.2|9.8|0.007
73877008|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|3.3||||0.826|TWO_SIDED|95.0|-26.1|32.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||32.8|-26.1|0.826
73956766|NCT01018511|147449448|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.83||0.043|TWO_SIDED|95.0|0.1|3.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.3|0.1|0.043
73956767|NCT01018511|147449448|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.84||0.12|TWO_SIDED|95.0|-0.3|3.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.0|-0.3|0.120
73956768|NCT01018511|147449448|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.82||0.003|TWO_SIDED|95.0|0.8|4.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.0|0.8|0.003
73956769|NCT01018511|147449448|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.83||0.014|TWO_SIDED|95.0|0.4|3.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||3.7|0.4|0.014
73956770|NCT01018511|147449448|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.83||0.384|TWO_SIDED|95.0|-0.9|2.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||2.4|-0.9|0.384
73956771|NCT01018511|147449449|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.92||0.004|TWO_SIDED|95.0|0.8|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.4|0.8|0.004
73956772|NCT01018511|147449449|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.93||0.035|TWO_SIDED|95.0|0.1|3.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.8|0.1|0.035
73956773|NCT01018511|147449449|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|0.91|<|0.001|TWO_SIDED|95.0|2.2|5.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.8|2.2|< 0.001
73956774|NCT01018511|147449449|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|1.5|5.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.1|1.5|< 0.001
73956775|NCT01018511|147449449|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.92||0.142|TWO_SIDED|95.0|-0.5|3.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||3.2|-0.5|0.142
73956776|NCT01018511|147449450|SUPERIORITY_OR_OTHER_LEGACY|||||||0.874|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).||||0.874
73956777|NCT01018511|147449450|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).||||0.240
73956778|NCT01018511|147449450|SUPERIORITY_OR_OTHER_LEGACY|||||||0.324|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.324
73956779|NCT01018511|147449450|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.043
73956780|NCT01018511|147449450|SUPERIORITY_OR_OTHER_LEGACY|||||||0.407|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.407
73956781|NCT01018511|147449457|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||<.001
73956782|NCT01018511|147449457|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||<.001
73956783|NCT01018511|147449457|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
73956784|NCT01018511|147449457|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
73956785|NCT01018511|147449457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.058
73956786|NCT01018511|147449458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.053
73877009|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|0.3||||1|TWO_SIDED|95.0|-27.2|27.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||27.7|-27.2|1.000
73877010|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-5.2||||0.649|TWO_SIDED|95.0|-27.8|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||17.3|-27.8|0.649
73877011|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-16.7||||0.304|TWO_SIDED|95.0|-45.7|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||12.4|-45.7|0.304
73877012|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|10.3||||0.72|TWO_SIDED|95.0|-18.2|38.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||38.7|-18.2|0.720
73877013|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|1.2||||0.923|TWO_SIDED|95.0|-23.0|25.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||25.4|-23.0|0.923
73877014|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-20.0||||0.197|TWO_SIDED|95.0|-50.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||10.4|-50.4|0.197
73956787|NCT01018511|147449458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.031
73956788|NCT01018511|147449458|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
73956789|NCT01018511|147449458|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
73998743|NCT01468181|147545960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|||<|0.001|TWO_SIDED|95.0|-1.75|-1.55|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 52 Weeks||-1.55|-1.75|<0.001
73998744|NCT01468181|147545962|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-43.9|||<|0.001|TWO_SIDED|95.0|-47.8|-40.0|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 26 Weeks||-40.0|-47.8|<0.001
73998745|NCT01468181|147545962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.6|||<|0.001|TWO_SIDED|95.0|-46.4|-38.7|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 52 Weeks||-38.7|-46.4|<0.001
73956790|NCT01018511|147449458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.018
73956791|NCT01018511|147449459|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.110
73956792|NCT01018511|147449459|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.071
73956793|NCT01018511|147449459|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
73956794|NCT01018511|147449459|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
73956795|NCT01018511|147449459|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.019
73956796|NCT04391309|147449494|SUPERIORITY|||||||0.435|||||||Log Rank|||||||0.435
73956797|NCT04391309|147449495|SUPERIORITY|||||||1|||||||Fisher Exact|||All categories included in the analysis||||1
73956798|NCT04391309|147449496|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||||||0.391
73956799|NCT04391309|147449497|SUPERIORITY|||||||0.895|||||||Wilcoxon (Mann-Whitney)|||||||0.895
73956800|NCT04391309|147449498|SUPERIORITY|||||||0.702|||||||Wilcoxon (Mann-Whitney)|||||||0.702
73956801|NCT04391309|147449499|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
73956802|NCT04391309|147449500|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis||||1
73998746|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.42|||<|0.001|TWO_SIDED|95.0|-46.55|-38.29|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 26 Weeks||-38.29|-46.55|<0.001
73998747|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.6|||<|0.001|TWO_SIDED|95.0|-46.44|-38.76|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 52 Weeks||-38.76|-46.44|<0.001
73998748|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-68.48|||<|0.001|TWO_SIDED|95.0|-74.18|-62.79|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 26 Weeks||-62.79|-74.18|<0.001
73998749|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.08|||<|0.001|TWO_SIDED|95.0|-72.12|-60.04|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 52 Weeks||-60.04|-72.12|<0.001
73998750|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.21|||<|0.001|TWO_SIDED|95.0|-53.32|-43.09|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 26 Weeks||-43.09|-53.32|<0.001
73998751|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.51|||<|0.001|TWO_SIDED|95.0|-52.77|-42.24|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 52 Weeks||-42.24|-52.77|<0.001
73998752|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.06|||<|0.001|TWO_SIDED|95.0|-73.02|-61.11|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 26 Weeks||-61.11|-73.02|<0.001
73998753|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.17|||<|0.001|TWO_SIDED|95.0|-69.16|-57.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 52 Weeks||-57.18|-69.16|<0.001
73998754|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.0|||<|0.001|TWO_SIDED|95.0|-49.67|-38.34|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 26 Weeks||-38.34|-49.67|<0.001
73998755|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.88|||<|0.001|TWO_SIDED|95.0|-49.55|-38.21|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 52 Weeks||-38.21|-49.55|<0.001
73998756|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.91|||<|0.001|TWO_SIDED|95.0|-69.32|-56.5|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 26 Weeks||-56.50|-69.32|<0.001
73998757|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.84|||<|0.001|TWO_SIDED|95.0|-66.95|-54.74|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 52 Weeks||-54.74|-66.95|<0.001
73998758|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.15|||<|0.001|TWO_SIDED|95.0|-66.93|-55.37|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 26 Weeks||-55.37|-66.93|<0.001
73998759|NCT01468181|147545963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.16|||<|0.001|TWO_SIDED|95.0|-66.07|-54.25|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 52 Weeks||-54.25|-66.07|<0.001
73998760|NCT01468181|147545964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|||<|0.277|TWO_SIDED|95.0|-0.4|0.12|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 26 Weeks||0.12|-0.40|<0.277
73877015|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|11.5||||0.486|TWO_SIDED|95.0|-20.4|43.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||43.5|-20.4|0.486
73956803|NCT04391309|147449501|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the anlysis.||||1
73956804|NCT04391309|147449502|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
73998761|NCT01468181|147545964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.382|TWO_SIDED|95.0|-0.42|0.16|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 52 Weeks||0.16|-0.42|0.382
73998762|NCT01468181|147545965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.59|||<|0.001|TWO_SIDED|95.0|26.0|31.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 26 Weeks||31.18|26.00|<0.001
73998763|NCT01468181|147545965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.57|||<|0.001|TWO_SIDED|95.0|24.73|30.41|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 52 Weeks||30.41|24.73|<0.001
73998764|NCT01468181|147545965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.194|TWO_SIDED|95.0|-6.46|1.32|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 26 Weeks||1.32|-6.46|0.194
73998765|NCT01468181|147545965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.4|TWO_SIDED|65.0|-5.68|2.27|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 52 Weeks||2.27|-5.68|0.400
73998766|NCT00878826|147545966|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||at 14-18 weeks gestational age||||0.4
73998767|NCT00878826|147545966|SUPERIORITY_OR_OTHER|||||||0.9|||||||Kruskal-Wallis|||at 24-28 weeks gestational age||||0.9
73998768|NCT00878826|147545966|SUPERIORITY_OR_OTHER|||||||0.3|||||||Kruskal-Wallis|||at 32-34 weeks gestational age||||0.3
73998769|NCT04828837|147545980|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|Mean Difference (Final Values)|0.39|||<|0.05|TWO_SIDED|95.0||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|Wilcoxon (Mann-Whitney)|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
73998770|NCT04828837|147545981|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|||||<|0.05||||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|The generalized estimating equation (GEE|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
73877016|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|17.9||||0.168|TWO_SIDED|95.0|-7.0|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||42.7|-7.0|0.168
73877017|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|-3.3||||0.833|TWO_SIDED|95.0|-34.3|27.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||27.6|-34.3|0.833
73956805|NCT04391309|147449503|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
73998771|NCT04828837|147545982|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|||||<|0.05||||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|The generalized estimating equation (GEE|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
73998772|NCT04828837|147545983|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
73998773|NCT01081132|147545990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.026|||<|0.001|TWO_SIDED|95.0|-8.865|-3.187|||Mixed Models Repeated Measures Analysis|||||-3.187|-8.865|<0.001
73998774|NCT01081132|147545991|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Cochran-Mantel-Haenszel|||||||0.010
73998775|NCT01081132|147545992|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.115||||0.104|TWO_SIDED|95.0|-0.254|0.024|||Mixed Models Repeated Measures Analysis|||||0.024|-0.254|0.104
73956806|NCT04391309|147449504|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
73956807|NCT04391309|147449505|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
73956808|NCT04548622|147449508|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
73956809|NCT04548622|147449509|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
73956810|NCT04548622|147449510|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73956811|NCT02908620|147449511|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|2.74||0.322|TWO_SIDED|95.0|-3.06|8.69|||ANOVA||Least squares mean (marginal mean)|||8.69|-3.06|0.322
73956812|NCT02908620|147449512|SUPERIORITY||Mean Difference (Final Values)|-8.7|STANDARD_ERROR_OF_MEAN|5.48||0.134|TWO_SIDED|95.0|-20.38|2.99|||ANOVA||Least squares mean (marginal mean)|||2.99|-20.38|0.134
73998776|NCT01081132|147545993|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057||||0.408|TWO_SIDED|95.0|-0.192|0.078|||Mixed Models Repeated Measures Analysis|||||0.078|-0.192|0.408
73956813|NCT02908620|147449513|SUPERIORITY||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|4.92||0.442|TWO_SIDED|95.0|-6.48|14.62|||ANOVA||Least squares mean (marginal mean)|||14.62|-6.48|0.442
73956814|NCT02908620|147449514|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|4.78||0.172|TWO_SIDED|95.0|-3.27|16.9|||ANOVA||Least squares mean (marginal mean)|||16.90|-3.27|0.172
73956815|NCT05824351|147449535|EQUIVALENCE|Equivalence is defined as an average difference of \< or = 2|Mean of paired differences|-0.2571|STANDARD_DEVIATION|0.7|<|0.0001|TWO_SIDED||||||t-test, 1 sided|One-sided lower t-test||Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).||||<0.0001
73998777|NCT01081132|147545994|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.083||||0.176|TWO_SIDED|95.0|-0.203|0.037|||Mixed Models Repeated Measures Analysis|||||0.037|-0.203|0.176
73998778|NCT01081132|147545995|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05||||0.253|TWO_SIDED|95.0|-0.136|-0.036|||Mixed Models Repeated Measures Analysis|||||-0.036|-0.136|0.253
73998779|NCT01081132|147545996|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.004||||0.912|TWO_SIDED|95.0|-0.061|0.068|||Mixed Models Repeated Measures Analysis|||||0.068|-0.061|0.912
73998780|NCT01081132|147545997|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.029||||0.606|TWO_SIDED|95.0|-0.139|0.081|||Mixed Models Repeated Measures Analysis|||||0.081|-0.139|0.606
73998781|NCT01081132|147545998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102||||0.228|TWO_SIDED|95.0|-0.064|0.268|||Mixed Models Repeated Measures Analysis|||||0.268|-0.064|0.228
73998782|NCT01081132|147545999|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.047||||0.41|TWO_SIDED|95.0|-0.159|0.065|||Mixed Models Repeated Measures Analysis|||||0.065|-0.159|0.410
73998783|NCT01081132|147546000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.208||||0.082|TWO_SIDED|95.0|-0.443|0.026|||Mixed Models Repeated Measures Analysis|||||0.026|-0.443|0.082
73998784|NCT01081132|147546001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73998785|NCT01081132|147546002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.134|TWO_SIDED|95.0|-5.3|0.7|||Mixed Models Repeated Measures Analysis|||Global Executive Composite||0.7|-5.3|0.134
73998786|NCT01081132|147546002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.579|TWO_SIDED|95.0|-4.0|2.3|||Mixed Models Repeated Measures Analysis|||Behavioral Regulation Index||2.3|-4.0|0.579
73998787|NCT01081132|147546002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7||||0.072|TWO_SIDED|95.0|-5.6|0.2|||Mixed Models Repeated Measures Analysis|||Metacognition Index||0.2|-5.6|0.072
73998788|NCT01081132|147546003|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.465|TWO_SIDED|95.0|-1.8|0.8|||Mixed Models Repeated Measures Analysis|||||0.8|-1.8|0.465
73998789|NCT04688320|147546051|NON_INFERIORITY|The margin of the non-inferiority was established as a difference in the primary efficacy endpoints between compared groups|Odds Ratio (OR)|0.75|||<|0.05|TWO_SIDED|95.0|0.11|4.52|||Welch's t-test|||||4.52|0.11|<0.05
73998790|NCT00383110|147546061|SUPERIORITY_OR_OTHER|||||||0.648|||||||ANOVA|||||||0.648
73998791|NCT00383110|147546062|SUPERIORITY_OR_OTHER|||||||0.14|||||||ANOVA|||||||0.14
73998792|NCT00383110|147546063|SUPERIORITY_OR_OTHER|||||||0.675|||||||ANOVA|||||||0.675
73998793|NCT00383110|147546064|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANOVA|||||||0.03
73998794|NCT00383110|147546065|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73998795|NCT00383110|147546066|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73998796|NCT03762200|147546067|OTHER|Confidence Interval|percentage of sucesses|87.4|||||TWO_SIDED|95.0|79.4|93.1||||||||93.1|79.4|
73998797|NCT03762200|147546068|OTHER|Confidence Interval|Percentage of Successes|77.7|||||TWO_SIDED|95.0|68.4|85.3||||||||85.3|68.4|
73998798|NCT03762200|147546069|OTHER|Confidence Interval|Percentage of Successes|92.2|||||TWO_SIDED|95.0|85.3|96.6||||||||96.6|85.3|
73998799|NCT02516332|147546130|OTHER|||||||0.038|||||||ANCOVA|||||||0.038
73998800|NCT02516332|147546130|OTHER|||||||0.002|||||||ANCOVA|||||||0.002
73998801|NCT02516332|147546135|OTHER|||||||0.011|||||||Regression, Linear|||||||0.011
73998802|NCT02516332|147546135|OTHER|||||||0.036|||||||Regression, Linear|||||||0.036
73998803|NCT00605215|147546141|OTHER||Risk Ratio (RR)|0.823|STANDARD_ERROR_OF_MEAN|0.09||0.0746|TWO_SIDED|95.0|0.664|1.02||Threshold for significance at 0.05 level.|Negative Binomial Regression|||Analysis was performed using baseline-adjusted negative binomial regression, where a participant's number of relapses during the double-blind, placebo-controlled phase served as the response variable and an offset based on the log of participant's exposure in years was employed to adjust for variability of treatment exposure. The model included baseline EDSS score, log of (prior 2-year number of relapses+1) and CGR as covariates.||1.020|0.664|0.0746
73998804|NCT00605215|147546141|OTHER||Risk Ratio (RR)|0.741|STANDARD_ERROR_OF_MEAN|0.082||0.0067|TWO_SIDED|95.0|0.596|0.92|||Negative Binomial Regression|||Analysis was performed using baseline-adjusted negative binomial regression, where a participant's number of relapses during the double-blind, placebo-controlled phase served as the response variable and an offset based on the log of participant's exposure in years was employed to adjust for variability of treatment exposure. The model included baseline EDSS score, log of (prior 2-year number of relapses+1) and CGR as covariates.||0.920|0.596|0.0067
73877018|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|22.6||||0.173|TWO_SIDED|95.0|-8.2|53.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||53.4|-8.2|0.173
73998805|NCT02704754|147546156|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
73998806|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||ANOVA|||Region of Interest is left anterior insula.||||0.2960
73998807|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||ANOVA|||Region of interest is left anterior insula.||||0.3450
73998808|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.1192||95.0|||||ANOVA|||Region of interest is left anterior putamen.||||0.1192
73998809|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.6639||95.0|||||ANOVA|||Region of interest is left anterior putamen.||||0.6639
73998810|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.8295||95.0|||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.||||0.8295
73998811|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.0078||95.0|||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.||||0.0078
73998812|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.7153||95.0|||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex.||||0.7153
73998813|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.8511||95.0|||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex||||0.8511
73998814|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.4228||95.0|||||ANOVA|||Region of interest is left parietal cortex||||0.4228
73998815|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.0611||95.0|||||ANOVA|||Region of interest is left parietal cortex||||0.0611
73998816|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.9879||95.0|||||ANOVA|||Region of interest is left premotor cortex||||0.9879
73998817|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.2065||95.0|||||ANOVA|||Region of interest is left premotor cortex||||0.2065
73998818|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.1837||95.0|||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area||||0.1837
73998819|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.8195||95.0|||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area||||0.8195
73998820|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.642||95.0|||||ANOVA|||Region of interest is left thalamus||||0.6420
73998821|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.7475||95.0|||||ANOVA|||Region of interest is left thalamus||||0.7475
73998822|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.9049||95.0|||||ANOVA|||Region of interest is left visual cortex||||0.9049
73998823|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||ANOVA|||Region of interest is left visual cortex||||0.1830
73998824|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.5318||95.0|||||ANOVA|||Region of interest is right anterior insula||||0.5318
73998825|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.9588||95.0|||||ANOVA|||Region of interest is right anterior insula||||0.9588
73998826|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.7551||95.0|||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex||||0.7551
73998827|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.7895||95.0|||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex||||0.7895
73998828|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.9494||95.0|||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex||||0.9494
73998829|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.4482||95.0|||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex||||0.4482
73998830|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.9343||95.0|||||ANOVA|||Region of interest is right parietal cortex||||0.9343
73998831|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.7711||95.0|||||ANOVA|||Region of interest is right parietal cortex||||0.7711
73998832|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.4755||95.0|||||ANOVA|||Region of interest is right premotor cortex||||0.4755
73998833|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.3982||95.0|||||ANOVA|||Region of interest is right premotor cortex||||0.3982
73998834|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.4622||95.0|||||ANOVA|||Region of interest is right thalamus||||0.4622
73998835|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.4604||95.0|||||ANOVA|||Region of interest is right thalamus||||0.4604
73998836|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.2485||95.0|||||ANOVA|||Region of interest is right visual cortex||||0.2485
73998837|NCT00657020|147546159|SUPERIORITY_OR_OTHER|||||||0.1931||95.0|||||ANOVA|||Region of interest is right visual cortex||||0.1931
73998838|NCT00657020|147546160|SUPERIORITY_OR_OTHER|||||||0.4535||95.0|||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.||||0.4535
73998839|NCT00657020|147546160|SUPERIORITY_OR_OTHER|||||||0.1811||95.0|||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.||||0.1811
73998840|NCT00657020|147546161|SUPERIORITY_OR_OTHER|||||||0.6261||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.6261
73998841|NCT00657020|147546161|SUPERIORITY_OR_OTHER|||||||0.0106||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.0106
73998842|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||ANOVA|||Region of interest is left parietal cortex.||||0.5544
73998843|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.6716||95.0|||||ANOVA|||Region of interest is left parietal cortex.||||0.6716
73998844|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.7511||95.0|||||ANOVA|||Region of interest is left superior occipital cortex.||||0.7511
74036489|NCT01029886|147626227|NON_INFERIORITY_OR_EQUIVALENCE|Superiority of exenatide once weekly with respect to change in HbA1c was concluded if the upper limit of the 2-sided 95% confidence interval (CI) for the treatment difference (exenatide once weekly minus liraglutide) was less than zero. Non-inferiority was concluded if the upper limit of the CI was \<0.25%.|Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|0.08|0.33|||Mixed Models Analysis|||A sample of 408 subjects in each treatment arm would provide approximately 90% power to detect a true difference between treatments of 0.25% in change in HbA1c from baseline with a 2 sided t-test at a significance level of 0.05, assuming a common standard deviation of 1.1%. MMRM model includes treatment, baseline HbA1c, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.33|0.08|0.002
74036490|NCT01029886|147626228|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel test, in which HbA1c stratum, country, and background OAD served as stratification factors.||||0.011
73998845|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.7959||95.0|||||ANOVA|||Region of interest is left superior occipital cortex.||||0.7959
73998846|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.6418||95.0|||||ANOVA|||Region of interest is left visual cortex.||||0.6418
73998847|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.2205||95.0|||||ANOVA|||Region of interest is left visual cortex.||||0.2205
73998848|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.5135||95.0|||||ANOVA|||Region of interest is right parietal cortex.||||0.5135
73998849|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.9781||95.0|||||ANOVA|||Region of interest is right parietal cortex.||||0.9781
73998850|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.3755||95.0|||||ANOVA|||Region of interest is right premotor cortex.||||0.3755
73998851|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.2612||95.0|||||ANOVA|||Region of interest is right premotor cortex.||||0.2612
73998852|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.8486||95.0|||||ANOVA|||Region of interest is right superior occipital cortex.||||0.8486
73998853|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.8318||95.0|||||ANOVA|||Region of interest is right superior occipital cortex.||||0.8318
73998854|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.7554||95.0|||||ANOVA|||Region of interest is right visual cortex.||||0.7554
73998855|NCT00657020|147546162|SUPERIORITY_OR_OTHER|||||||0.5421||95.0|||||ANOVA|||Region of interest is right visual cortex.||||0.5421
73998856|NCT00657020|147546163|SUPERIORITY_OR_OTHER|||||||0.1963||95.0|||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.||||0.1963
73998857|NCT00657020|147546163|SUPERIORITY_OR_OTHER|||||||0.0959||95.0|||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.||||0.0959
73998858|NCT00657020|147546164|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.5400
73998859|NCT00657020|147546164|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||Null hypothesis considered the treatments in comparison to be equal.||||0.1800
73998860|NCT00774930|147546180|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|TWO_SIDED||||||ANCOVA|This analysis does not include any imputation for the early roll over subjects||||||0.0165
73998861|NCT00774930|147546181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2544|||||||ANCOVA|ANCOVA included treatment group and 2 stratification variables at randomisation as factors and average frequency of diarrhoea per day during Screening||||||0.2544
73998862|NCT01177800|147546286|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
73998863|NCT01177800|147546287|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 10: p-value was calculated by Non parametric ANOVA by van der Waerden method.||||<0.001
73998864|NCT01177800|147546288|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
73998865|NCT01177800|147546289|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 26: p-value was calculated by Non parametric ANOVA by van der Waerden method.||||<0.001
73998866|NCT03527550|147546291|SUPERIORITY|||||||0.95|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in negative urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in negative urgency as a function of condition (interaction of condition X time; reported below).||||0.95
74036491|NCT01029886|147626229|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.15||0.021|TWO_SIDED|95.0|0.05|0.66|||Mixed Models Analysis|||MMRM model includes treatment, baseline fasting serum glucose, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.66|0.05|0.021
73877019|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|17.6||||0.178|TWO_SIDED|95.0|-7.6|42.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||42.8|-7.6|0.178
73956816|NCT05824351|147449535|EQUIVALENCE|Equivalence is defined as an average difference of \< or = 2|Mean of paired differences|0.0294|STANDARD_DEVIATION|0.79||0.0003|TWO_SIDED||||||t-test, 1 sided|One-sided upper t-test||Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).||||0.0003
73956817|NCT02929069|147449609|SUPERIORITY||Risk Ratio (RR)|0.88||||0.52|TWO_SIDED|95.0|0.52|1.25|||Regression, Logistic|||||1.25|.52|0.52
73956818|NCT02162446|147449671|OTHER|||||||0.016|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.016
73956819|NCT02162446|147449671|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
73956820|NCT02162446|147449671|OTHER|||||||0.012|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.012
73956821|NCT02162446|147449671|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
73956822|NCT02162446|147449671|OTHER|||||||0.5|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.500
73956823|NCT02162446|147449671|OTHER|||||||1|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||1.000
73956824|NCT02162446|147449673|OTHER|||||||0.25|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.250
73956825|NCT02162446|147449673|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
73956826|NCT02162446|147449673|OTHER|||||||0.688|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.688
73956827|NCT02162446|147449673|OTHER|||||||0.578|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.578
73956828|NCT02162446|147449674|OTHER|||||||0.027|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.027
73998867|NCT03527550|147546292|SUPERIORITY|||||||0.64|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in positive urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in positive urgency as a function of condition (interaction of condition X time; reported below).||||0.64
73998868|NCT03527550|147546293|SUPERIORITY|||||||0.91||||||Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).|ANOVA|||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in stop-signal reaction time at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in stop-signal reaction time as a function of condition (interaction of condition X time; reported below).||||0.91
73998869|NCT03527550|147546297|SUPERIORITY|||||||0.24|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in distress intolerance at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in distress intolerance as a function of condition (interaction of condition X time; reported below).||||.24
73998870|NCT00911937|147546299|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.37|-0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.08|-0.37|0.0030
73998871|NCT00911937|147546300|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.0772|TWO_SIDED|95.0|-0.27|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.01|-0.27|0.0772
73998872|NCT00911937|147546301|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0001
73998873|NCT00911937|147546303|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0827|TWO_SIDED|95.0|-0.25|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.01|-0.25|0.0827
74090620|NCT02728752|147734879|SUPERIORITY||Median Difference (Net)|-0.4||||0.0002|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||-0.2|-0.5|0.0002
73877020|NCT02365649|147294853|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-30.9|30.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANCOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||30.9|-30.9|1.000
73877021|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-27.8||||0.58|TWO_SIDED|95.0|-71.9|16.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||16.3|-71.9|0.580
73877022|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-6.9||||1|TWO_SIDED|95.0|-53.6|39.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||39.7|-53.6|1.000
73877023|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-24.4||||0.58|TWO_SIDED|95.0|-72.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||23.3|-72.2|0.580
73877024|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-38.9||||0.287|TWO_SIDED|95.0|-83.0|5.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||5.2|-83.0|0.287
73956829|NCT02162446|147449674|OTHER|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.219
73956830|NCT02162446|147449675|OTHER|||||||0.064|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.064
73956831|NCT02162446|147449675|OTHER|||||||0.339|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.339
73956832|NCT02162446|147449675|OTHER|||||||0.001|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.001
73956833|NCT02162446|147449675|OTHER|||||||0|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.000
73956834|NCT02162446|147449675|OTHER|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.297
73956835|NCT02162446|147449675|OTHER|||||||1|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||1.000
73956836|NCT02162446|147449676|OTHER|||||||0.47|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.470
73956837|NCT02162446|147449676|OTHER|||||||0.233|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.233
74090621|NCT02728752|147734885|SUPERIORITY||Median Difference (Net)|-1.2||||0.001|TWO_SIDED|95.0|-1.9|-0.5|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||-0.5|-1.9|0.0010
74090622|NCT02025751|147734889|SUPERIORITY|||||||0.597|||||||ANCOVA|||||||0.597
74090623|NCT01846273|147734890|NON_INFERIORITY|pre-defined non-inferiority margin of 5 letters|Least Squares Mean|3.2|||<|0.001|ONE_SIDED|95.0|0.38||||ANCOVA||||||0.38|<0.001
74090624|NCT01846273|147734891|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74090625|NCT03182582|147735029|SUPERIORITY|||||||0.003|||||||Paired t test|||A sample size of 22 patients was required to achieve 80% power, using a two-tailed test with α = 0.05.||||0.003
73956838|NCT02162446|147449676|OTHER|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.375
73956839|NCT02162446|147449677|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.004
73956840|NCT02162446|147449677|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
73956841|NCT02162446|147449677|OTHER|||||||0.426|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.426
74090626|NCT00605865|147735119|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."||||<0.001
73877025|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-5.6||||1|TWO_SIDED|95.0|-53.0|41.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||41.9|-53.0|1.000
73956842|NCT02162446|147449677|OTHER|||||||0.098|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.098
73956843|NCT02162446|147449677|OTHER|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.813
73998874|NCT00911937|147546303|SUPERIORITY_OR_OTHER||Least Squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.0112|TWO_SIDED|95.0|-0.33|-0.04||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.04|-0.33|0.0112
74090627|NCT00605865|147735120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.039
74090628|NCT00605865|147735121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."||||0.011
73956844|NCT02162446|147449677|OTHER|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.813
73956845|NCT02162446|147449677|OTHER|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.297
73956846|NCT02162446|147449677|OTHER|||||||0.469|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.469
73956847|NCT02162446|147449678|OTHER|||||||0.91|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.910
73956848|NCT02162446|147449678|OTHER|||||||0.039|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.039
73956849|NCT02162446|147449678|OTHER|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.375
73956850|NCT02162446|147449678|OTHER|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.219
73956851|NCT04358549|147449683|SUPERIORITY||Median Difference (Final Values)|14.0||||0.0415|TWO_SIDED|90.0|||||Log Rank|||||||0.0415
73956852|NCT04358549|147449684|SUPERIORITY||Odds Ratio (OR)|0.653|||||TWO_SIDED|90.0|0.19|2.24||||||||2.240|0.190|
73956853|NCT04358549|147449685|SUPERIORITY||Median Difference (Final Values)|3.0||||0.9879|TWO_SIDED|90.0|||||Log Rank|||||||0.9879
73956854|NCT00157014|147449717|SUPERIORITY_OR_OTHER|||||||0.4725||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)|||||||0.4725
73956855|NCT00157014|147449728|SUPERIORITY_OR_OTHER|||||||0.8373||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)|||||||0.8373
73956856|NCT01362491|147449731|SUPERIORITY_OR_OTHER||Least-Square (LS) mean difference|6.11|||<|0.001|TWO_SIDED|95.0|4.49|7.73||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||7.73|4.49|<0.001
73877026|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-15.6||||1|TWO_SIDED|95.0|-69.4|38.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||38.3|-69.4|1.000
73877027|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-27.8||||0.58|TWO_SIDED|95.0|-71.9|16.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||16.3|-71.9|0.580
73877028|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-41.9|53.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||53.0|-41.9|1.000
73877029|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-24.4||||0.58|TWO_SIDED|95.0|-72.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||23.3|-72.2|0.580
73998875|NCT00911937|147546304|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0023
73998876|NCT00911937|147546306|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.15||0.0026|TWO_SIDED|95.0|-0.74|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.16|-0.74|0.0026
73998877|NCT00911937|147546306|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.17||0.0014|TWO_SIDED|95.0|-0.9|-0.22||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.22|-0.90|0.0014
73998878|NCT00911937|147546307|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0016
73877030|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-44.4||||0.103|TWO_SIDED|95.0|-76.9|-12.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||-12.0|-76.9|0.103
73877031|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-41.9|53.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||53.0|-41.9|1.000
73998879|NCT00911937|147546307|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0004
73998880|NCT00911937|147546309|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.0072|TWO_SIDED|95.0|-1.03|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.16|-1.03|0.0072
73998881|NCT00911937|147546309|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.24||0.0009|TWO_SIDED|95.0|-1.25|-0.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.32|-1.25|0.0009
73877032|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-4.4||||1|TWO_SIDED|95.0|-58.3|49.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||49.4|-58.3|1.000
73998882|NCT00911937|147546310|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0041
74036492|NCT01029886|147626230|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|0.39|1.4|||Mixed Models Analysis|||MMRM model includes treatment, baseline body weight, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||1.40|0.39|<.001
74036493|NCT01029886|147626231|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.05||0.079|TWO_SIDED|95.0|-0.01|0.19|||Mixed Models Analysis|||MMRM model includes treatment, baseline total cholesterol, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.19|-0.01|0.079
73877033|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-48.7|48.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||48.7|-48.7|1.000
73877034|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|16.7||||0.637|TWO_SIDED|95.0|-29.7|63.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||63.0|-29.7|0.637
73877035|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-60.0|33.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||33.3|-60.0|1.000
73877036|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|18.6||||0.57|TWO_SIDED|95.0|-29.4|66.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||66.6|-29.4|0.570
73998883|NCT00911937|147546310|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
73998884|NCT00911937|147546312|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.3954|TWO_SIDED|95.0|-0.47|0.19||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.19|-0.47|0.3954
73998885|NCT00911937|147546312|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.2166|TWO_SIDED|95.0|-0.48|0.11||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.11|-0.48|0.2166
73998886|NCT00911937|147546315|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.1018|TWO_SIDED|95.0|-0.85|0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.08|-0.85|0.1018
74090629|NCT00605865|147735122|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||0.010
73877037|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-14.8||||0.33|TWO_SIDED|95.0|-39.7|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||10.2|-39.7|0.330
73877038|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-10.3||||1|TWO_SIDED|95.0|-40.0|19.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||19.4|-40.0|1.000
73877039|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|18.6||||0.57|TWO_SIDED|95.0|-29.4|66.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||66.6|-29.4|0.570
73998887|NCT00911937|147546315|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0027|TWO_SIDED|95.0|-1.2|-0.25||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.25|-1.20|0.0027
73877040|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-14.8||||0.33|TWO_SIDED|95.0|-39.7|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||10.2|-39.7|0.330
73877041|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-33.8|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||35.4|-33.8|1.000
73998888|NCT00911937|147546317|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.63||0.0131|TWO_SIDED|95.0|-2.79|-0.33||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.33|-2.79|0.0131
74090630|NCT00605865|147735123|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."||||<0.001
73877042|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-1.4||||1|TWO_SIDED|95.0|-42.6|39.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||39.7|-42.6|1.000
73877043|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-21.4||||0.1|TWO_SIDED|95.0|-42.9|0.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||0.1|-42.9|0.100
73877044|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-33.8|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||35.4|-33.8|1.000
73998889|NCT00911937|147546317|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.43|STANDARD_ERROR_OF_MEAN|0.69||0.0004|TWO_SIDED|95.0|-3.78|-1.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-1.08|-3.78|0.0004
73998890|NCT00911937|147546319|SUPERIORITY_OR_OTHER||Least squares mean difference|1.32|STANDARD_ERROR_OF_MEAN|7.2||0.8547|TWO_SIDED|95.0|-12.82|15.46||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||15.46|-12.82|0.8547
73998891|NCT00911937|147546321|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.85|STANDARD_ERROR_OF_MEAN|4.22||0.8396|TWO_SIDED|95.0|-9.14|7.44||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||7.44|-9.14|0.8396
73998892|NCT00911937|147546323|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.37|STANDARD_ERROR_OF_MEAN|1.26||0.0006|TWO_SIDED|95.0|-6.84|-1.89||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-1.89|-6.84|0.0006
73998893|NCT00911937|147546325|SUPERIORITY_OR_OTHER||Least squares mean difference|3.42|STANDARD_ERROR_OF_MEAN|1.34||0.011|TWO_SIDED|95.0|0.79|6.05||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||6.05|0.79|0.0110
73998894|NCT00911937|147546325|SUPERIORITY_OR_OTHER||Least squares mean difference|3.14|STANDARD_ERROR_OF_MEAN|1.35||0.02|TWO_SIDED|95.0|0.5|5.79||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.79|0.50|0.0200
73998895|NCT00911937|147546325|SUPERIORITY_OR_OTHER||Least squares mean difference|3.48|STANDARD_ERROR_OF_MEAN|1.51||0.0218|TWO_SIDED|95.0|0.51|6.45||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||6.45|0.51|0.0218
73998896|NCT00911937|147546325|SUPERIORITY_OR_OTHER||Least squares mean difference|1.86|STANDARD_ERROR_OF_MEAN|0.93||0.0458|TWO_SIDED|95.0|0.03|3.68||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||3.68|0.03|0.0458
73998897|NCT00911937|147546325|SUPERIORITY_OR_OTHER||Least squares mean difference|3.02|STANDARD_ERROR_OF_MEAN|1.17||0.01|TWO_SIDED|95.0|0.72|5.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.32|0.72|0.0100
73998898|NCT01498679|147546326|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|51.0|||<|0.001|TWO_SIDED|95.0|42.2|59.7|||ANCOVA|||||59.7|42.2|<0.001
73998899|NCT00294515|147546384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<=|0.0002|TWO_SIDED|95.0|0.25|0.66|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.66|0.25|<=0.0002
73998900|NCT00294515|147546385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2|||<|0.0001||95.0|0.11|0.37|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.37|0.11|<0.0001
73998901|NCT00294515|147546386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.0001||95.0|0.22|0.6|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.60|0.22|0.0001
74036494|NCT01029886|147626232|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.832|TWO_SIDED|95.0|-0.02|0.02|||Mixed Models Analysis|||MMRM model includes treatment, baseline HDL-C, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.02|-0.02|0.832
73998902|NCT00294515|147546387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.0126||95.0|0.35|0.88|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.88|0.35|0.0126
73998903|NCT00294515|147546388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.01||95.0|0.34|0.86|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.86|0.34|0.0100
73998904|NCT01472549|147546414|SUPERIORITY||Risk Ratio (RR)|0.55||||0.02|TWO_SIDED|95.0|0.34|0.9|||Chi-squared|||||0.90|0.34|0.02
73998905|NCT01472549|147546415|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
73998906|NCT01472549|147546416|SUPERIORITY||Risk Ratio (RR)|0.76||||0.37|TWO_SIDED|95.0|0.43|1.37|||Chi-squared|||||1.37|0.43|0.37
73998907|NCT01472549|147546417|SUPERIORITY||Risk Ratio (RR)|0.73||||0.49|TWO_SIDED|95.0|0.3|1.8|||Chi-squared|||||1.80|0.30|0.49
73998908|NCT01472549|147546418|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
73998909|NCT01472549|147546419|SUPERIORITY||Risk Ratio (RR)|2.02||||0.56|TWO_SIDED|95.0|0.18|22.11|||Fisher Exact|||||22.11|0.18|0.56
73877045|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|5.7||||1|TWO_SIDED|95.0|-33.8|45.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||45.3|-33.8|1.000
73998910|NCT01056718|147546515|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of treatment. Each subject served as his/her own control.||||<0.05
73877046|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-7.6||||0.598|TWO_SIDED|95.0|-29.9|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.6|-29.9|0.598
73998911|NCT01056718|147546516|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
73998912|NCT01056718|147546517|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
73998913|NCT01056718|147546518|SUPERIORITY_OR_OTHER||||||=|0.078|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.078
73998914|NCT01056718|147546519|SUPERIORITY_OR_OTHER||||||=|0.186|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.186
73998915|NCT01056718|147546520|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
73998916|NCT01056718|147546521|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
73998917|NCT01056718|147546522|SUPERIORITY_OR_OTHER||||||=|0.06|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.06
73998918|NCT01056718|147546523|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
73998919|NCT01056718|147546524|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
73998920|NCT01056718|147546525|SUPERIORITY_OR_OTHER||||||=|0.85|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.85
73998921|NCT01056718|147546526|SUPERIORITY_OR_OTHER||||||=|0.4|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.40
73998922|NCT01056718|147546527|SUPERIORITY_OR_OTHER||||||=|0.64|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.64
73998923|NCT01056718|147546528|SUPERIORITY_OR_OTHER||||||=|0.49|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.49
73998924|NCT01056718|147546529|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.47
73998925|NCT01056718|147546530|SUPERIORITY_OR_OTHER||||||=|0.55|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.55
73998926|NCT01056718|147546531|SUPERIORITY_OR_OTHER||||||=|0.64|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.64
73998927|NCT01056718|147546532|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
73998928|NCT01056718|147546533|SUPERIORITY_OR_OTHER||||||=|0.526|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.526
73998929|NCT01056718|147546534|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
73998930|NCT01056718|147546535|SUPERIORITY_OR_OTHER||||||=|0.925|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.925
73998931|NCT01056718|147546536|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
73998932|NCT01056718|147546537|SUPERIORITY_OR_OTHER||||||=|0.458|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.458
73998933|NCT01056718|147546538|SUPERIORITY_OR_OTHER||||||=|0.561|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.561
73998934|NCT01056718|147546539|SUPERIORITY_OR_OTHER||||||=|0.734|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.734
73998935|NCT01056718|147546540|SUPERIORITY_OR_OTHER||||||=|0.129|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.129
73998936|NCT05086276|147546542|SUPERIORITY||Odds Ratio (OR)|1.4||||0.525|TWO_SIDED|95.0|0.51|3.73||P value for statistical significance is \<0.05|Chi-squared|||||3.73|0.51|0.525
73998937|NCT05086276|147546542|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.525|TWO_SIDED|95.0|-7.52|14.71||P value for statistical significance is \<0.05|Chi-squared|||||14.71|-7.52|0.525
73998938|NCT05086276|147546543|SUPERIORITY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.491||0.973|TWO_SIDED|95.0|-0.954|0.987||P value for statistical significance is \<0.05|Mixed Models Analysis|||||0.987|-0.954|0.973
73998939|NCT05086276|147546545|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.16|TWO_SIDED|95.0|-0.06|0.34||P value for statistical significance is \<0.05|ANCOVA|||||0.34|-0.06|0.160
73998940|NCT05086276|147546546|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.027|TWO_SIDED|95.0|0.03|0.41||P value for statistical significance is \<0.05|ANCOVA|||||0.41|0.03|0.027
73998941|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.002||||||This is the PCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.002
73998942|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.23||||||This is the MCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.23
73998943|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.18||||||This is the Burden KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.18
73998944|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.02||||||This is the Symptoms KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.02
74036495|NCT01029886|147626233|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|1.04|1.15|||Mixed Models Analysis|||Fasting triglycerides were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM model with treatment, baseline fasting triglycerides, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||1.15|1.04|<.001
74036496|NCT01029886|147626234|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|0.76||0.205|TWO_SIDED|95.0|-0.53|2.47|||Mixed Models Analysis|||MMRM model includes treatment, baseline SBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||2.47|-0.53|0.205
74036497|NCT01029886|147626235|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.5||0.981|TWO_SIDED|95.0|-0.96|0.98|||Mixed Models Analysis|||MMRM model includes treatment, baseline DBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.98|-0.96|0.981
74036498|NCT01778127|147626238|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.90
74036499|NCT01778127|147626238|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
74036500|NCT01778127|147626238|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||0.14
74036501|NCT01778127|147626239|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
74036502|NCT01778127|147626239|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||t-test, 2 sided|||||||0.84
74036503|NCT01778127|147626239|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||t-test, 2 sided|||||||0.37
73877047|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-3.2||||1|TWO_SIDED|95.0|-30.7|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||24.3|-30.7|1.000
74090631|NCT00605865|147735124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with and without suicidal ideation(including suicide attempt) in the participants of responders."||||0.014
74090632|NCT00605865|147735125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."||||0.021
74090633|NCT00605865|147735126|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was target disease severity. The null hypothesis is there is no difference between three grade of target disease severity in the participants of responders."||||<0.001
74036504|NCT01778127|147626240|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
74036505|NCT01778127|147626240|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||t-test, 2 sided|||||||0.63
74036506|NCT01778127|147626240|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.09
74036507|NCT01778127|147626241|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
74036508|NCT01778127|147626241|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
74036509|NCT01778127|147626241|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
74036510|NCT01778127|147626242|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||t-test, 2 sided|||||||0.61
74036511|NCT01778127|147626242|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||t-test, 2 sided|||||||0.64
74036512|NCT01778127|147626242|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||t-test, 2 sided|||||||0.99
74036513|NCT01778127|147626243|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||t-test, 2 sided|||||||0.69
74036514|NCT01778127|147626243|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
74036515|NCT01778127|147626243|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||||||0.59
74036516|NCT01778127|147626244|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
74036517|NCT01778127|147626244|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
74036518|NCT01778127|147626244|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
74036519|NCT01778127|147626245|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
74036520|NCT01778127|147626245|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
74036521|NCT01778127|147626245|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||t-test, 2 sided|||||||0.99
74036522|NCT01778127|147626246|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
74036523|NCT01778127|147626246|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
74036524|NCT01778127|147626246|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||t-test, 2 sided|||||||0.54
74036525|NCT01778127|147626247|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||||||0.17
74036526|NCT01778127|147626247|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||t-test, 2 sided|||||||0.13
74036527|NCT01778127|147626247|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
74036528|NCT01778127|147626248|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
74036529|NCT01778127|147626248|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
74036530|NCT01778127|147626248|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
74036531|NCT01778127|147626249|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
74036532|NCT01778127|147626249|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
74036533|NCT01778127|147626249|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
74090634|NCT00605865|147735127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was history of treatment prior to Sertralin. The null hypothesis is there is no difference between with and without history of treatment prior to Sertralin in the participants of responders."||||0.003
74090635|NCT00605865|147735128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was outpatient or inpatient. The null hypothesis is there is no difference between outpatient or inpatient in the participants of responders."||||0.012
73998945|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.004||||||This is the Effects KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.004
73998946|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.01||||||This is the PCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.01
73998947|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.21||||||This is the MCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.21
73998948|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
73998949|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Symptoms KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
73998950|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.14||||||This is the Effects KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.14
73998951|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.45||||||This is the PCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.45
73998952|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.79||||||This is the MCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.79
73998953|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
73998954|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.03||||||This is the Symptoms KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.03
73998955|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.12||||||This is the Effects KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.12
74039813|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.21||0.1778|TWO_SIDED|95.0|-0.71|0.13|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.71|0.1778
73998956|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.29||||||This is the PCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.29
73998957|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.01||||||This is the MCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.01
73998958|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.08||||||This is the Burden KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.08
73998959|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.61||||||This is the Symptoms KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.61
73998960|NCT02270515|147546552|SUPERIORITY_OR_OTHER|||||||0.02||||||This is the Effects KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.02
74090636|NCT00605865|147735129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."||||0.019
73877048|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|12.9||||0.468|TWO_SIDED|95.0|-24.7|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Non-responders, Week 52|Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|50.4|-24.7|0.468
73998961|NCT01237587|147546562|SUPERIORITY||LS mean change difference|-0.65|STANDARD_ERROR_OF_MEAN|0.33||0.052|TWO_SIDED|95.0|-1.3|0.0|||Repeated Measures|||||0.00|-1.30|0.052
73998962|NCT01237587|147546563|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.36||0.059|TWO_SIDED|95.0|-1.4|0.03|||Mixed Models Analysis|||Worst Pain||0.03|-1.40|.059
73998963|NCT01237587|147546563|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.319||0.059|TWO_SIDED|95.0|-1.24|0.02|||Mixed Models Analysis|||Least Pain||0.02|-1.24|0.059
73998964|NCT01237587|147546563|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.365||0.165|TWO_SIDED|95.0|-1.23|0.21|||Mixed Models Analysis|||Pain Right Now||0.21|-1.23|.165
73998965|NCT01237587|147546563|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.344||0.005|TWO_SIDED|95.0|-1.65|-0.3|||Mixed Models Analysis|||General Activity||-0.30|-1.65|0.005
73998966|NCT01237587|147546563|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.356||0.128|TWO_SIDED|95.0|-1.25|0.16|||Mixed Models Analysis|||Mood||0.16|-1.25|.128
73998967|NCT01237587|147546563|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.352||0.56|TWO_SIDED|95.0|-0.9|0.49|||Mixed Models Analysis|||Walking ability||0.49|-0.90|.560
73998968|NCT01237587|147546563|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.371||0.448|TWO_SIDED|95.0|-1.01|0.45|||Mixed Models Analysis|||Normal Work||0.45|-1.01|0.448
73998969|NCT01237587|147546563|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.312||0.011|TWO_SIDED|95.0|-1.42|-0.19|||Mixed Models Analysis|||Relations With Other||-0.19|-1.42|.011
73998970|NCT01237587|147546563|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.454||0.443|TWO_SIDED|95.0|-1.25|0.55|||Mixed Models Analysis|||Sleep||0.55|-1.25|.443
73998971|NCT01237587|147546563|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.338||0.39|TWO_SIDED|95.0|-0.96|0.38|||Mixed Models Analysis|||Enjoyment of Life||0.38|-0.96|.390
73998972|NCT01237587|147546563|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.424||0.16|TWO_SIDED|95.0|-1.44|0.24|||Mixed Models Analysis|||School Work||0.24|-1.44|.160
73998973|NCT01237587|147546565|SUPERIORITY|||||||0.051|||||||Fisher Exact|||||||.051
73998974|NCT01237587|147546566|SUPERIORITY|||||||0.038|||||||Fisher Exact|||||||.038
74090637|NCT00605865|147735130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."||||0.010
73998975|NCT01237587|147546567|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.669|TWO_SIDED|95.0|-9.1|5.86|||ANCOVA|||Average Pain Score||5.86|-9.10|.669
74090638|NCT00605865|147735131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was age. The null hypothesis is there is no difference between four groups of age in the participants of responders."||||0.015
73877049|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|6.2||||1|TWO_SIDED|95.0|-15.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||28.1|-15.7|1.000
73998976|NCT01237587|147546567|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.169|TWO_SIDED|95.0|-14.32|2.53|||ANCOVA|||Worst Pain Score||2.53|-14.32|.169
73998977|NCT01237587|147546567|SUPERIORITY||Mean Difference (Final Values)|-1.79||||0.647|TWO_SIDED|95.0|-9.53|5.94|||ANCOVA|||Pain Score Right Now||5.94|-9.53|.647
73998978|NCT01237587|147546568|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.146|TWO_SIDED|95.0|-0.52|0.08|||ANCOVA|||||0.08|-0.52|.146
73998979|NCT01237587|147546569|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.927|TWO_SIDED|95.0|-0.23|0.21|||ANCOVA|||||0.21|-0.23|.927
73998980|NCT01237587|147546570|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.431|TWO_SIDED|95.0|-1.54|3.59|||ANCOVA|||||3.59|-1.54|.431
73998981|NCT01237587|147546571|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.529|TWO_SIDED|95.0|-1.95|3.79|||ANCOVA|||||3.79|-1.95|.529
73998982|NCT01237587|147546572|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.335|TWO_SIDED|95.0|-2.52|0.86|||ANCOVA|||||0.86|-2.52|.335
73998983|NCT01237587|147546573|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.955|TWO_SIDED|95.0|-1.59|1.68|||ANCOVA|||Physical Symptoms Score||1.68|-1.59|.955
74039814|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.22||0.3438|TWO_SIDED|95.0|-0.65|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.65|0.3438
73877050|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|15.1||||0.538|TWO_SIDED|95.0|-15.2|45.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||45.4|-15.2|0.538
73877051|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-11.2||||0.692|TWO_SIDED|95.0|-48.0|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||25.6|-48.0|0.692
73998984|NCT01237587|147546573|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.381|TWO_SIDED|95.0|-1.82|0.7|||ANCOVA|||Harm Avoidance||0.70|-1.82|.381
73998985|NCT01237587|147546573|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.486|TWO_SIDED|95.0|-1.66|0.79|||ANCOVA|||Social Anxiety||0.79|-1.66|.486
73998986|NCT01237587|147546573|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.7|TWO_SIDED|95.0|-1.17|0.79|||ANCOVA|||Separation/Panic||0.79|-1.17|.700
73998987|NCT01237587|147546573|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.54|TWO_SIDED|95.0|-5.12|2.69|||ANCOVA|||Total Score||2.69|-5.12|.540
73998988|NCT01747551|147546591|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.72
73998989|NCT01142115|147546595|NON_INFERIORITY_OR_EQUIVALENCE|The estimated difference VAS(Monza) minus VAS(SpeediCath)(i.e. the upper confidence limit) shall be less than 1cm to demonstrate non-inferiority.|Mean Difference (Final Values)|1.052||||0.0018|TWO_SIDED|95.0|0.412|1.692|||Mixed Models Analysis|||||1.692|0.412|0.0018
73998990|NCT01142115|147546596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.805|||<|0.0001|TWO_SIDED|95.0|2.604|12.939|||Regression, Logistic|||||12.939|2.604|<0.0001
73998991|NCT01142115|147546597|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.616|TWO_SIDED|95.0|0.382|1.767|||Proportional odds regression model|||||1.767|0.382|0.6160
73998992|NCT01142115|147546598|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.117||||0.8014|TWO_SIDED|95.0|0.472|2.646|||Proportional odds regression model|||||2.646|0.472|0.8014
73998993|NCT01142115|147546599|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.503||||0.3085|TWO_SIDED|95.0|0.314|39.106|||Regression, Logistic|||||39.106|0.314|0.3085
73998994|NCT01142115|147546600|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.398||||0.4324|TWO_SIDED|95.0|0.606|3.225|||Proportional odds regression model|||||3.225|0.606|0.4324
73998995|NCT00633880|147546601|SUPERIORITY_OR_OTHER|||||||0.509||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the primary endpoint was not positive, statistical analysis was not performed on secondary endpoints.|Wilcoxon (Mann-Whitney)|||||||0.509
73998996|NCT00633880|147546606|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
73998997|NCT03208036|147546612|SUPERIORITY||||||=|0.69|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .69
73998998|NCT03208036|147546612|SUPERIORITY||||||=|0.74|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .74
73998999|NCT03208036|147546613|SUPERIORITY||||||=|0.62|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .62
73999000|NCT03208036|147546613|SUPERIORITY||||||=|0.24|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .24
73999001|NCT03208036|147546614|SUPERIORITY||||||=|0.47|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .47
73999002|NCT03208036|147546614|SUPERIORITY||||||=|0.09|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .09
73999003|NCT03208036|147546614|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .02
73999004|NCT03208036|147546614|SUPERIORITY||||||=|0.48|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .48
73999005|NCT03208036|147546614|SUPERIORITY||||||=|0.66|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .66
73999006|NCT03208036|147546614|SUPERIORITY||||||=|0.46|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5 month assessment.||||= .46
73999007|NCT03208036|147546615|SUPERIORITY||||||=|0.68|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .68
73999008|NCT03208036|147546615|SUPERIORITY||||||=|0.45|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .45
73999009|NCT03208036|147546616|SUPERIORITY||||||=|0.81|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .81
73999010|NCT03208036|147546616|SUPERIORITY||||||=|0.31|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .31
73999011|NCT03208036|147546617|SUPERIORITY||||||=|0.79|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .79
73999012|NCT03208036|147546617|SUPERIORITY||||||=|0.5|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .50
73999013|NCT03208036|147546618|SUPERIORITY||||||=|0.47|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .47
73999014|NCT03208036|147546618|SUPERIORITY||||||=|0.09|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .09
73877052|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-14.5||||0.388|TWO_SIDED|95.0|-46.9|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||17.9|-46.9|0.388
73999015|NCT03208036|147546618|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .02
73999016|NCT03208036|147546618|SUPERIORITY||||||=|0.48|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .48
73999017|NCT03208036|147546618|SUPERIORITY||||||=|0.66|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .66
73999018|NCT03208036|147546618|SUPERIORITY||||||=|0.46|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .46
73999019|NCT03208036|147546619|SUPERIORITY||||||=|0.99|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .99
73999020|NCT03208036|147546619|SUPERIORITY||||||=|0.84|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .84
73999021|NCT03208036|147546620|SUPERIORITY||||||=|0.25|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .25
73999022|NCT03208036|147546620|SUPERIORITY||||||=|0.08|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .08
73999023|NCT03208036|147546620|SUPERIORITY||||||=|0.14|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .14
73999024|NCT03208036|147546620|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .02
73999025|NCT03208036|147546620|SUPERIORITY||||||=|0.24|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .24
73999026|NCT03208036|147546620|SUPERIORITY||||||=|0.93|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .93
73999027|NCT03208036|147546621|SUPERIORITY||||||=|0.98|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .98
73999028|NCT03208036|147546621|SUPERIORITY||||||=|0.08|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .08
73999029|NCT03208036|147546621|SUPERIORITY||||||=|0.08|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .08
73999030|NCT03208036|147546621|SUPERIORITY||||||=|0.06|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .06
73999031|NCT03208036|147546621|SUPERIORITY||||||=|0.28|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .28
73999032|NCT03208036|147546621|SUPERIORITY||||||=|0.23|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .23
73999033|NCT03406078|147546622|SUPERIORITY||Cumulative Odds Ratio|1.28||||0.434|TWO_SIDED|95.0|0.69|2.35|||Proportional odds model|Response variable: categorised % reduction from baseline in final OCS dose. Covariates in the model: treatment, region and daily OCS dose at baseline.||||2.35|0.69|0.434
73999034|NCT00350103|147546666|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||=|0.041|TWO_SIDED|95.0|-0.88|-0.02|||ANCOVA||Estimated value is the difference of Least Square Means.|Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.||-0.02|-0.88|=0.0410
74090639|NCT00605865|147735132|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with or without suicidal ideation (including suicide attempt) in the participants of responders."||||<0.001
73877053|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-19.0||||0.418|TWO_SIDED|95.0|-54.8|16.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||16.9|-54.8|0.418
73877054|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-17.1||||0.448|TWO_SIDED|95.0|-54.1|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||20.0|-54.1|0.448
73877055|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-13.7||||0.43|TWO_SIDED|95.0|-47.4|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||19.9|-47.4|0.430
73877056|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-42.8|37.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||37.6|-42.8|1.000
73877057|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-21.2||||0.406|TWO_SIDED|95.0|-55.3|12.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||12.9|-55.3|0.406
73999035|NCT00350103|147546666|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||=|0.2902|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA||Estimated value is the difference of Least Square Means.|Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.||0.20|-0.65|=0.2902
73999036|NCT04664400|147546735|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.043|||||||t-test, 1 sided|||||||0.043
73999037|NCT04664400|147546736|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.036|||||||t-test, 1 sided|||||||0.036
73999038|NCT04664400|147546737|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.012|||||||t-test, 1 sided|||||||0.012
73999039|NCT04664400|147546738|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.835|||||||t-test, 1 sided|||||||0.835
73877058|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-14.5||||0.388|TWO_SIDED|95.0|-46.9|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||17.9|-46.9|0.388
73999040|NCT01011153|147546743|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes computed based on data from smaller studies provided 90% power for the comparison of sensitivity. Under the alternative hypothesis that the biopsy sensitivity of MelaFind would be 0.10 greater than the average biopsy/referral sensitivity of physicians (combined or separate), the probability that a 95% CI lies entirely above zero will be at least 90% when the standard error of the estimated difference is at most 0.0308.|Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.03|<|0.0001|TWO_SIDED|95.0|0.18|0.32|||ANOVA|||Using True Positives/All Positives, sensitivity values were calculated for MelaFind as well as the average of the 110 dermatologists.||0.32|0.18|<0.0001
73999041|NCT01011153|147546744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_DEVIATION|0.04|<|0.0001|TWO_SIDED|95.0|0.19|0.34|||ANOVA|||Sensitivity||0.34|0.19|<0.0001
73999042|NCT01011153|147546744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.04|<|0.0001|TWO_SIDED|95.0|0.16|0.31|||ANOVA|||Sensitivity||0.31|0.16|<0.0001
73999043|NCT01011153|147546744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_DEVIATION|0.03|<|0.0001|TWO_SIDED|95.0|0.19|0.33|||ANOVA|||Sensitivity||0.33|0.19|<0.0001
73999044|NCT01011153|147546744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.46|-0.25|||ANOVA|||Specificity||-0.25|-0.46|<0.0001
73999045|NCT01011153|147546744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.53|-0.31|||ANOVA|||Specificity||-0.31|-0.53|<0.0001
73999046|NCT01011153|147546744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.51|-0.3|||ANOVA|||Specificity||-0.30|-0.51|<0.0001
73999047|NCT01011153|147546745|SUPERIORITY_OR_OTHER||Kappa|0.313|STANDARD_ERROR_OF_MEAN|0.003||||0.0||||No comparison is being made.|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
73999048|NCT01011153|147546745|SUPERIORITY_OR_OTHER||Kappa|0.276|STANDARD_ERROR_OF_MEAN|0.002||||0.0||||No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
73999049|NCT01011153|147546745|SUPERIORITY_OR_OTHER||Kappa|0.2|STANDARD_ERROR_OF_MEAN|0.003||||0.0||||No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
73999050|NCT01011153|147546745|SUPERIORITY_OR_OTHER||Kappa|0.256|STANDARD_ERROR_OF_MEAN|0.001||||0.0||||N/A - No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
73999051|NCT03014479|147546747|SUPERIORITY||Differences of Least Square Means|2.418||||0.2305|TWO_SIDED|95.0|-1.546|6.382|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||6.382|-1.546|0.2305
73999052|NCT03014479|147546748|SUPERIORITY||Differences of Least Square Means|1.938||||0.4536|TWO_SIDED|95.0|-3.15|7.027|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||7.027|-3.150|0.4536
73999053|NCT03014479|147546749|SUPERIORITY||Differences of Least Square Means|4.16||||0.0896|TWO_SIDED|95.0|-0.649|8.968|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||8.968|-0.649|0.0896
74036534|NCT01348425|147626250|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin is +/- 10%, type I error is assumed to be 0.05, with a power of 0.8.|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|4.1|<|0.01|TWO_SIDED|95.0|-2.0|3.5||Schuirman's TOST equivalence test on change in stent length upon deployment between longer and shorter stents.|t-test, 2 sided|To test the hypothesis whether the percent change in stent length is contained within \[-10%, 10%\].||The alternative hypothesis is equivalence in mean change in stent length upon deployment between longer and shorter stents, i.e., the difference in mean change between the longer and shorter stents is close to 0. Thus, a small p-value indicates a 95% confidence interval covers 0.||3.5|-2.0|<0.01
74036535|NCT01963208|147626270|OTHER||Median Difference (Final Values)|-7.06||||0.1788|TWO_SIDED|95.0|-17.44|3.52||The null hypothesis is that there is no difference between the distributions of the two treatment groups with respect to percent change in seizure frequency.|Rank ANCOVA|||||3.52|-17.44|0.1788
74036536|NCT03260205|147626333|SUPERIORITY||Difference in Least Square Mean|-5.9||||0.0242|TWO_SIDED|95.0|-11.01|-0.78|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline visits, with the change from baseline in ADHD-RS-IV preschool version total score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline ADHD-RS-IV and baseline ADHD-RS-IV score-by-visit interaction as covariates.||-0.78|-11.01|0.0242
74036537|NCT03260205|147626334|SUPERIORITY||Difference in Least Mean Square|-0.6||||0.0074|TWO_SIDED|95.0|-1.03|-0.16|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline Visits, with the CGI-I score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline CGI-S as covariate.||-0.16|-1.03|0.0074
74036538|NCT05301322|147626351|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for both RSV A and RSV B NTs.|GMR|0.86|||||TWO_SIDED|95.0|0.785|0.951|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|RSV A||0.951|0.785|
74036539|NCT05301322|147626351|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for both RSV A and RSV B NTs.|GMR|0.85|||||TWO_SIDED|95.0|0.766|0.943|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|RSV B||0.943|0.766|
74036540|NCT05301322|147626352|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.86|||||TWO_SIDED|95.0|0.769|0.963|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: H1N1 A/Victoria||0.963|0.769|
74090640|NCT02130583|147735248|SUPERIORITY||Mean Difference (Net)|2.06||||0.034|TWO_SIDED||||||ANOVA|||||||.034
74090641|NCT02119286|147735290|SUPERIORITY_OR_OTHER||Least squared mean difference|0.122|||<|0.001|TWO_SIDED|95.0|0.091|0.152|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.152|0.091|<0.001
74090642|NCT02119286|147735290|SUPERIORITY_OR_OTHER||Least squared mean difference|0.111|||<|0.001|TWO_SIDED|95.0|0.081|0.141|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.141|0.081|<0.001
73999054|NCT03014479|147546750|SUPERIORITY||Differences of Least Square Means|-0.563||||0.8506|TWO_SIDED|95.0|-6.448|5.323|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||5.323|-6.448|0.8506
73999055|NCT03014479|147546751|SUPERIORITY||Differences of Least Square Means|2.696||||0.3533|TWO_SIDED|95.0|-3.018|8.41|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||8.410|-3.018|0.3533
73999056|NCT03014479|147546753|SUPERIORITY||Differences of Least Square Means|0.613||||0.5451|TWO_SIDED|95.0|-1.38|2.605|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||2.605|-1.380|0.5451
73999057|NCT01781078|147546769|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.3|||<|0.0001|ONE_SIDED|95.0||3.9|||Farrington-Manning score test|||||3.9||<0.0001
73999058|NCT01781078|147546770|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.1||||0.0006|ONE_SIDED|95.0||5.0|||Farrington-Manning score test|||||5.0||0.0006
73999059|NCT01781078|147546770|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|0.0||||0.0002|ONE_SIDED|95.0||4.7|||Farrington-Manning score test|||||4.7||0.0002
73999060|NCT05038163|147546785|SUPERIORITY||Treatment Effect|-0.51|||<|0.001|TWO_SIDED|95.0|-0.63|-0.39|||Regression, Linear|||||-0.39|-0.63|<0.001
73999061|NCT05038163|147546785|SUPERIORITY||Treatment Effect|-0.45|||<|0.001|TWO_SIDED|95.0|-0.57|-0.33|||Regression, Linear|||||-0.33|-0.57|<0.001
73999062|NCT05038163|147546785|SUPERIORITY||Treatment Effect|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.24|||Regression, Linear|||||-0.24|-0.44|<0.001
73999063|NCT05038163|147546786|SUPERIORITY||Treatment Effect|-0.33||||0.003|TWO_SIDED|95.0|-0.55|-0.11|||Regression, Linear|||||-0.11|-0.55|0.003
73999064|NCT05038163|147546786|SUPERIORITY||Treatment Effect|-0.61|||<|0.001|TWO_SIDED|95.0|-0.87|-0.35|||Regression, Linear|||||-0.35|-0.87|<0.001
73999065|NCT05038163|147546786|SUPERIORITY||Treatment Effect|-0.25|||<|0.001|TWO_SIDED|95.0|-0.48|-0.17|||Regression, Linear|||||-0.17|-0.48|<0.001
73999066|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.5|||<|0.001|TWO_SIDED|95.0|-0.67|-0.32|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.32|-0.67|<0.001
73999067|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.53|||<|0.001|TWO_SIDED|95.0|-0.7|-0.36|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Male||-0.36|-0.70|<0.001
73999068|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.41|||<|0.001|TWO_SIDED|95.0|-0.57|-0.25|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.25|-0.57|<0.001
74036541|NCT05301322|147626352|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.77|||||TWO_SIDED|95.0|0.68|0.866|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: H3N2 A/Darwin||0.866|0.680|
74036542|NCT05301322|147626352|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.9|||||TWO_SIDED|95.0|0.789|1.019|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: B/Austria||1.019|0.789|
74036543|NCT05301322|147626352|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.87|||||TWO_SIDED|95.0|0.779|0.964|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: B/Phuket||0.964|0.779|
74036544|NCT03829332|147626363|OTHER||Hazard Ratio (HR)|0.78||||0.00624|TWO_SIDED|95.0|0.64|0.95|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||Hazards ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||0.95|0.64|0.00624
74036545|NCT03829332|147626364|OTHER||Hazard Ratio (HR)|1.1||||0.79744|TWO_SIDED|95.0|0.87|1.39|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG, region, and baseline PD-L1 status.||HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||1.39|0.87|0.79744
74036546|NCT03829332|147626365|OTHER||Percent Difference|12.8||||0.00037|TWO_SIDED|95.0|5.4|20.1|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.||Percent difference and 95% CI were calculated using Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||20.1|5.4|0.00037
74036547|NCT03829332|147626368|OTHER|Difference in LS means and 95% CI were calculated using the Constrained longitudinal data analysis (cLDA) model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in Least Square (LS) Means|-3.9||||0.0262|TWO_SIDED|95.0|-7.34|-0.47|||Constrained longitudinal data analysis|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||-0.47|-7.34|0.0262
74036548|NCT03829332|147626369|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-4.5||||0.0461|TWO_SIDED|95.0|-8.91|-0.08||Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.|cLDA model|||||-0.08|-8.91|0.0461
74039815|NCT02528253|147632453|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.22||0.1876|TWO_SIDED|95.0|-0.71|0.14|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.14|-0.71|0.1876
73877059|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-7.8||||1|TWO_SIDED|95.0|-46.5|30.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||30.8|-46.5|1.000
73999069|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.32|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Male||-0.32|-0.65|<0.001
73999070|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.28|||<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.14|-0.42|<0.001
73999071|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.57|||<|0.001|TWO_SIDED|95.0|-0.57|-0.27|||Regression, Linear|||Gender subgroup: Male|Unit: $ per 12-pack|-0.27|-0.57|<0.001
73999072|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-2.23|||<|0.001|TWO_SIDED|95.0|-3.34|-1.12|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||-1.12|-3.34|<0.001
73999073|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.69|||<|0.001|TWO_SIDED|95.0|-1.15|-0.23|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.23|-1.15|<0.001
73999074|NCT05038163|147546787|SUPERIORITY||Treatment Effect|0.8|||<|0.001|TWO_SIDED|95.0|0.8|0.8|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.80|0.80|<0.001
73999075|NCT05038163|147546787|SUPERIORITY||Treatment Effect|0.45|||<|0.001|TWO_SIDED|95.0|-0.24|1.14|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||1.14|-0.24|<0.001
73999076|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.5|||<|0.001|TWO_SIDED|95.0|-0.63|-0.37|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: White||-0.37|-0.63|<0.001
73999077|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.96|||<|0.001|TWO_SIDED|95.0|-1.67|-0.25|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.25|-1.67|<0.001
73999078|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.38|||<|0.001|TWO_SIDED|95.0|-1.16|0.4|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.40|-1.16|<0.001
74036549|NCT03829332|147626370|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-1.1||||0.5596|TWO_SIDED|95.0|-4.78|2.59|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||2.59|-4.78|0.5596
74036550|NCT03829332|147626371|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-0.88||||0.7088|TWO_SIDED|95.0|-5.49|3.74|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||3.74|-5.49|0.7088
74036551|NCT03829332|147626372|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-3.01||||0.1116|TWO_SIDED|95.0|-6.71|0.7|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||0.70|-6.71|0.1116
74090643|NCT02119286|147735291|SUPERIORITY_OR_OTHER||Least squared mean difference|0.147|||<|0.001|TWO_SIDED|95.0|0.114|0.179|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.179|0.114|<0.001
74090644|NCT02119286|147735291|SUPERIORITY_OR_OTHER||Least squared mean difference|0.135|||<|0.001|TWO_SIDED|95.0|0.103|0.167|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.167|0.103|<0.001
74090645|NCT03623386|147735309|SUPERIORITY|||||||0.981|||||||Wilcoxon (Mann-Whitney)|||||||0.981
74090646|NCT03623386|147735310|SUPERIORITY|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
74090647|NCT03623386|147735311|SUPERIORITY||||||>|0.05|||||||ANOVA|||Testing for main effects (group), time effect and the interaction of group and time.||||>0.05
73877060|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-25.3||||0.204|TWO_SIDED|95.0|-54.7|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||4.1|-54.7|0.204
73877061|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-2.0||||0.907|TWO_SIDED|95.0|-34.9|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||31.0|-34.9|0.907
74090648|NCT03623386|147735312|SUPERIORITY|||||||0.026||||||p value reflects the effect of time.|ANOVA|||Testing for main effects (group), time effect and the interaction of group and time.||||0.026
74090649|NCT04271735|147735335|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
74090650|NCT00515541|147735338|SUPERIORITY_OR_OTHER|||||||0.01||||||A P-value \<0.05 when compared to baseline is considered significant.|Wilcoxon (Mann-Whitney)|||Group B baseline vs. Group B Week 12||||0.01
73999079|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.44|||<|0.001|TWO_SIDED|95.0|-1.07|0.19|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||0.19|-1.07|<0.001
73999080|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.54|||<|0.001|TWO_SIDED|95.0|-0.91|-0.17|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.17|-0.91|<0.001
73999081|NCT05038163|147546787|SUPERIORITY||Treatment Effect|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.00|0.00|<0.001
73999082|NCT05038163|147546787|SUPERIORITY||Treatment Effect|0.16|||<|0.001|TWO_SIDED|95.0|-0.36|0.68|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||0.68|-0.36|<0.001
73999083|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.44|||<|0.001|TWO_SIDED|95.0|-0.57|-0.31|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: white||-0.31|-0.57|<0.001
73999084|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-1.18|||<|0.001|TWO_SIDED|95.0|-2.04|-0.32|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.32|-2.04|<0.001
73999085|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.38|||<|0.001|TWO_SIDED|95.0|-0.9|0.14|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.14|-0.90|<0.001
74090651|NCT00515541|147735339|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 6.||||<0.001
74090652|NCT00515541|147735339|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 12.||||<0.001
73999086|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.79|||<|0.001|TWO_SIDED|95.0|-1.54|-0.04|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||-0.04|-1.54|<0.001
73999087|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.51|||<|0.001|TWO_SIDED|95.0|-0.9|-0.12|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.12|-0.90|<0.001
73999088|NCT05038163|147546787|SUPERIORITY||Treatment Effect|0.8|||<|0.001|TWO_SIDED|95.0|0.8|0.8|||Regression, Logistic||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.80|0.80|<0.001
73999089|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.04|||<|0.001|TWO_SIDED|95.0|-0.79|0.71|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||0.71|-0.79|<0.001
73999090|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.33|||<|0.001|TWO_SIDED|95.0|-0.44|-0.22|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: White||-0.22|-0.44|<0.001
73999091|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.41|||<|0.001|TWO_SIDED|95.0|-0.76|-0.06|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.06|-0.76|<0.001
73999092|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.27|||<|0.001|TWO_SIDED|95.0|-0.85|0.31|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.31|-0.85|<0.001
73877062|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|-2.0||||1|TWO_SIDED|95.0|-40.2|36.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||36.3|-40.2|1.000
74036552|NCT03829332|147626373|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.0||||0.9601|TWO_SIDED|95.0|0.75|1.33|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.33|0.75|0.9601
74036553|NCT03829332|147626374|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|0.61||||0.0079|TWO_SIDED|95.0|0.42|0.88|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||0.88|0.42|0.0079
74036554|NCT03829332|147626375|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.06||||0.7457|TWO_SIDED|95.0|0.73|1.56|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.56|0.73|0.7457
74036555|NCT03829332|147626376|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.04||||0.8122|TWO_SIDED|95.0|0.75|1.44|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.44|0.75|0.8122
74036556|NCT03829332|147626377|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.24||||0.148|TWO_SIDED|95.0|0.92|1.67|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.67|0.92|0.1480
74036557|NCT03829332|147626378|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.31||||0.4068|TWO_SIDED|95.0|0.7|2.46|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||2.46|0.70|0.4068
74036558|NCT03003403|147626452|SUPERIORITY||Risk Ratio (RR)|1.0||||0.97|TWO_SIDED|95.0|0.82|1.2|||bootstrap resampling|||||1.20|0.82|0.97
74090653|NCT02040779|147735341|SUPERIORITY||LSM difference|0.116||||0.001|TWO_SIDED|95.0|0.048|0.185||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 160 mcg BAI - Placebo BAI|A fixed-sequence multiple testing procedure was used while controlling the family-wise error rate at 5%. If the 2-sided p-value resulting from the ANCOVA model for comparing beclomethasone dipropionate BAI 160 mcg/day versus placebo was less than 0.05, then the comparison of the 80 mcg/day versus placebo was to be interpreted inferentially.||0.185|0.048|0.0010
73956857|NCT01362491|147449732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.253|TWO_SIDED|95.0|0.88|1.65||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.65|0.88|0.253
73999093|NCT05038163|147546787|SUPERIORITY||Treatment Effect|0.23|||<|0.001|TWO_SIDED|95.0|-0.45|0.91|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.91|-0.45|<0.001
74036559|NCT03003403|147626453|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.83|TWO_SIDED|95.0|-1.24|1.0|||Mixed Models Analysis|||||1.00|-1.24|0.83
74036560|NCT03003403|147626454|SUPERIORITY|Difference in systolic blood pressure change post-baseline comparing intervention to usual care arm at 24 months.|Mean Difference (Final Values)|-1.2||||0.34|TWO_SIDED|95.0|-3.6|1.3|||Mixed Models Analysis|||||1.3|-3.6|0.34
74090654|NCT02040779|147735341|SUPERIORITY||LSM difference|0.124||||0.0005|TWO_SIDED|95.0|0.054|0.193||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 80 mcg BAI - Placebo BAI|||0.193|0.054|0.0005
73999094|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.52|||<|0.001|TWO_SIDED|95.0|-0.65|-0.39|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.39|-0.65|<0.001
73999095|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.93|||<|0.001|TWO_SIDED|95.0|-1.48|-0.38|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Other or Prefer Not to Say||-0.38|-1.48|<0.001
73999096|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.16|||<|0.001|TWO_SIDED|95.0|-0.7|0.38|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.38|-0.70|<0.001
73999097|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.45|||<|0.001|TWO_SIDED|95.0|-0.57|-0.33|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.33|-0.57|<0.001
74036561|NCT03003403|147626454|SUPERIORITY|Difference in diastolic blood pressure change post-baseline comparing intervention to usual care arm at 24 months.|Mean Difference (Final Values)|-0.8||||0.323|TWO_SIDED|95.0|-2.4|0.8|||Mixed Models Analysis|||||0.8|-2.4|0.323
73999098|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.79|||<|0.001|TWO_SIDED|95.0|-1.42|-0.16|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Other or Prefer Not to Say||-0.16|-1.42|<0.001
74036562|NCT03003403|147626455|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.991|TWO_SIDED|95.0|-0.8|0.8|||Mixed Models Analysis|||||0.8|-0.8|0.991
74036563|NCT02198651|147626456|OTHER|||||||0.943|||||||Wald Chi|||||||0.943
74036564|NCT02198651|147626457|OTHER|||||||0.592|||||||Wald Chi|||||||0.592
74036565|NCT02198651|147626458|OTHER|||||||0.688|||||||Wald Chi|||||||0.688
74036566|NCT03006471|147626507|SUPERIORITY|||||||0.755||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.755
74036567|NCT03006471|147626507|SUPERIORITY|||||||0.046||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.046
73999099|NCT05038163|147546787|SUPERIORITY||Treatment Effect|0.01||||0.98|TWO_SIDED|95.0|-0.4|0.41|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.41|-0.40|0.980
73999100|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.36|||<|0.001|TWO_SIDED|95.0|-0.47|-0.25|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.25|-0.47|<0.001
73999101|NCT05038163|147546787|SUPERIORITY||Treatment Effect|-0.39|||<|0.001|TWO_SIDED|95.0|-1.03|0.25|||Regression, Linear||Unit: $ per 12-pack|Ethnicity Subgroup: Other or Prefer Not to Say||0.25|-1.03|<0.001
74036568|NCT03006471|147626508|SUPERIORITY|||||||0.752||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.752
74036569|NCT03006471|147626508|SUPERIORITY|||||||0.582||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.582
74036570|NCT03006471|147626509|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
74036571|NCT03006471|147626509|SUPERIORITY|||||||0.22||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.220
74036572|NCT03006471|147626510|SUPERIORITY|||||||0.624||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.624
74036573|NCT03006471|147626510|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||1.000
74036574|NCT03006471|147626511|SUPERIORITY|||||||0.906||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.906
74036575|NCT03006471|147626511|SUPERIORITY|||||||0.017||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.017
74036576|NCT03006471|147626512|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.454
74036577|NCT03006471|147626512|SUPERIORITY|||||||0.115||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.115
74036578|NCT03006471|147626513|SUPERIORITY|||||||0.422||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.422
74036579|NCT03006471|147626513|SUPERIORITY|||||||0.917||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.917
74036580|NCT03006471|147626514|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.650
73999102|NCT00432666|147546788|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97|STANDARD_ERROR_OF_MEAN|1.49|<|0.001|TWO_SIDED|95.0|1.9|8.3|||Regression, Logistic|||The null hypothesis was equality of the chance (OR = 1) for a clinically relevant treatment effect between incobotulinumtoxinA (Xeomin) and placebo at Week 4 for wrist flexors. Responders were defined as subjects with an improvement of at least 1 point in the Ashworth score compared with Baseline. The dependent variable was the response to treatment, the independent variables were treatment, Ashworth score at the Baseline Visit, pre-treated patient status, gender, age, BMI, and pooled sites.||8.30|1.90|<0.001
73999103|NCT00969709|147546880|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.23||||0.0186|TWO_SIDED|95.0|-5.92|-0.54|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.54|-5.92|0.0186
73999104|NCT00969709|147546880|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.99||||0.0038|TWO_SIDED|95.0|-6.69|-1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-1.29|-6.69|0.0038
73999105|NCT00969709|147546880|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.86||||0.0005|TWO_SIDED|95.0|-7.59|-2.12|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-2.12|-7.59|0.0005
74036581|NCT03006471|147626514|SUPERIORITY|||||||0.108||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.108
74036582|NCT03006471|147626515|SUPERIORITY|||||||0.875||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.875
74036583|NCT03006471|147626515|SUPERIORITY|||||||0.196||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference in dapagliflozin group||||0.196
74036584|NCT03006471|147626516|SUPERIORITY|||||||0.552||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.552
74036585|NCT03006471|147626516|SUPERIORITY|||||||0.087||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.087
74036586|NCT03006471|147626517|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
73877063|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|6.5||||1|TWO_SIDED|95.0|-28.4|41.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||41.3|-28.4|1.000
73956858|NCT01362491|147449733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.38|||<|0.001|TWO_SIDED|95.0|2.69|7.14||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||7.14|2.69|<0.001
73999106|NCT00969709|147546881|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.41||||0.1687|TWO_SIDED|95.0|-3.42|0.6|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||0.60|-3.42|0.1687
73999107|NCT00969709|147546881|SUPERIORITY_OR_OTHER||least squares mean difference|-2.51||||0.0151|TWO_SIDED|95.0|-4.54|-0.49|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.49|-4.54|0.0151
73999108|NCT00969709|147546881|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.57||||0.0141|TWO_SIDED|95.0|-4.62|-0.52|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.52|-4.62|0.0141
73999109|NCT00452426|147546892|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||ANOVA|||||||0.028
73999110|NCT00452426|147546894|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANOVA|||||||0.007
73999111|NCT00452426|147546895|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73999112|NCT02914275|147546902|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% confidence interval (CI) of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.88||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||0.88|0.72|
73999113|NCT02914275|147546902|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.27|||||TWO_SIDED|95.0|1.15|1.42||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.42|1.15|
73999114|NCT02914275|147546902|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.12|||||TWO_SIDED|95.0|1.01|1.24||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.24|1.01|
73999115|NCT02914275|147546902|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.09||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.09|0.86|
73999116|NCT02914275|147546903|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|-10.3|||||TWO_SIDED|95.0|-15.4|-5.1||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||-5.1|-15.4|
73999117|NCT02914275|147546903|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|2.6|||||TWO_SIDED|95.0|-2.54|7.8||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||7.8|-2.54|
73999118|NCT02914275|147546903|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|3.1|||||TWO_SIDED|95.0|-2.1|8.2||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||8.2|-2.1|
73999119|NCT02914275|147546903|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|0.9|||||TWO_SIDED|95.0|-4.2|6.1||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||6.1|-4.2|
73999120|NCT00091169|147546912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
73999121|NCT00091169|147546913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.64
73999122|NCT00091169|147546914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.93
73999123|NCT00091169|147546915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.61
73999124|NCT00091169|147546916|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-05|TWO_SIDED||||||Fisher Exact|||||||0.00001
73956859|NCT01362491|147449733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.64|||<|0.001|TWO_SIDED|95.0|2.23|5.94||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||5.94|2.23|<0.001
73956860|NCT01362491|147449734|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.68|||<|0.001|TWO_SIDED|95.0|2.87|7.64||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||7.64|2.87|<0.001
73956861|NCT01362491|147449734|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.88|||<|0.001|TWO_SIDED|95.0|2.38|6.34||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||6.34|2.38|<0.001
73956862|NCT01362491|147449734|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.247|TWO_SIDED|95.0|0.88|1.66||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.66|0.88|0.247
73956863|NCT01362491|147449735|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.26|||<|0.001|TWO_SIDED|95.0|0.92|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.92|<0.001
73956864|NCT01362491|147449735|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.27|||<|0.001|TWO_SIDED|95.0|0.93|1.61||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.61|0.93|< 0.001
73956865|NCT01362491|147449735|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.01||||0.943|TWO_SIDED|95.0|-0.29|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.27|-0.29|0.943
73956866|NCT01362491|147449735|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.89|1.62||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.62|0.89|<0.001
73956867|NCT01362491|147449735|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.22|||<|0.001|TWO_SIDED|95.0|0.85|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.85|<0.001
73956868|NCT01362491|147449735|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.03||||0.847|TWO_SIDED|95.0|-0.27|0.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-0.27|0.847
73956869|NCT01362491|147449735|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.59|||<|0.001|TWO_SIDED|95.0|1.14|2.05||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.05|1.14|<0.001
73956870|NCT01362491|147449735|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.68|||<|0.001|TWO_SIDED|95.0|1.22|2.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.13|1.22|<0.001
73956871|NCT01362491|147449735|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.08||||0.663|TWO_SIDED|95.0|-0.46|0.29||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - (Ibuprofen IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.29|-0.46|0.663
73956872|NCT01362491|147449736|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.54|||<|0.001|TWO_SIDED|95.0|0.37|0.72||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.72|0.37|<0.001
73956873|NCT01362491|147449736|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.51|||<|0.001|TWO_SIDED|95.0|0.33|0.69||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|0.33|<0.001
73999125|NCT00091169|147546917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677|TWO_SIDED||||||Fisher Exact|||||||0.677
73999126|NCT00872989|147546918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.49|TWO_SIDED|80.0|0.79|1.26|||Regression, Cox|||||1.26|0.79|0.49
73999127|NCT00872989|147546920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.83|TWO_SIDED|80.0|0.93|1.68|||Regression, Cox|||||1.68|0.93|0.83
73999128|NCT01302067|147546935|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.16|-0.66||Primary comparison was 8 mg VS. 4 mg (closed-testing method). Treatment effect of 8 mg VS. placebo was tested 1st. Treatment difference of 8 mg VS. 4 mg was tested if a statistically significant difference between 8 mg and placebo was shown.|ANCOVA|Using a closed testing procedure, no adjustments of α-level was needed at each stage of testing. Each was done at the 0.05 significance level.|Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Comparisons were done with 2-sided test at 5% significance level. Null hypothesis: mean change from BL in the number of UUI episodes per 24 hours in the 8mg group was same as 4mg group at Week 12. ANCOVA was used to compare 8mg and 4mg arms for numeric change from BL - Week 12. This included terms for treatment, country, centered BL value and centered BL by treatment interaction, in which centered BL (BL - mean BL) was used to ensure that treatment effect was estimated at mean covariate value.||-0.66|-1.16|<0.0001
73999129|NCT01302067|147546935|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.11||0.0109|TWO_SIDED|95.0|-0.48|-0.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.||-0.06|-0.48|0.0109
73999130|NCT01302067|147546935|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.89|-0.39||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.||-0.39|-0.89|<0.0001
73999131|NCT01302067|147546936|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.48|-0.79||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.79|-1.48|<0.0001
73999132|NCT01302067|147546936|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0082|TWO_SIDED|95.0|-0.67|-0.1||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.10|-0.67|0.0082
73999133|NCT01302067|147546936|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.1|-0.41||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.41|-1.10|<0.0001
73999134|NCT01302067|147546937|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.76|-1.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.03|-1.76|<0.0001
74036587|NCT03006471|147626517|SUPERIORITY|||||||0.463||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.463
74036588|NCT03006471|147626518|SUPERIORITY|||||||0.53||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.530
74036589|NCT03006471|147626518|SUPERIORITY|||||||0.507||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.507
74036590|NCT03006471|147626519|SUPERIORITY|||||||0.152||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.152
73999135|NCT01302067|147546937|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.15||0.0006|TWO_SIDED|95.0|-0.83|-0.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.23|-0.83|0.0006
73999136|NCT01302067|147546937|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.23|-0.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.51|-1.23|<0.0001
74036591|NCT03006471|147626519|SUPERIORITY|||||||0.972||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.972
74036592|NCT03006471|147626520|SUPERIORITY|||||||0.152||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.152
74036593|NCT03006471|147626520|SUPERIORITY|||||||0.158||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.158
74036594|NCT03006471|147626521|SUPERIORITY|||||||0.944||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.944
73999137|NCT01302067|147546938|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
73999138|NCT01302067|147546938|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0040
73999139|NCT01302067|147546938|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
73999140|NCT01302067|147546939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
73999141|NCT01302067|147546939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
73999142|NCT01302067|147546939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
73999143|NCT01302067|147546940|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.02|-0.5||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||-0.50|-1.02|<0.0001
73999144|NCT01302067|147546940|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0662|TWO_SIDED|95.0|-0.41|0.01||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||0.01|-0.41|0.0662
73999145|NCT01302067|147546940|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.3||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||-0.30|-0.82|<0.0001
73999146|NCT01302067|147546941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
73999147|NCT01302067|147546941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
73999148|NCT01302067|147546942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
73999149|NCT01302067|147546942|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0006
73999150|NCT01302067|147546942|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0001
73999151|NCT01302067|147546943|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.55|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-2.04|-1.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.06|-2.04|<0.0001
73999152|NCT01302067|147546943|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0121|TWO_SIDED|95.0|-0.92|-0.11||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.11|-0.92|0.0121
74036595|NCT03006471|147626521|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.650
73999153|NCT01302067|147546943|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.52|-0.55||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.55|-1.52|<0.0001
73877064|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|16.5||||0.45|TWO_SIDED|95.0|-15.5|48.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||48.4|-15.5|0.450
73877065|NCT02365649|147294854|SUPERIORITY||Risk Difference (RD)|9.8||||0.661|TWO_SIDED|95.0|-27.0|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||46.6|-27.0|0.661
73999154|NCT01302067|147546944|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.55|-1.49||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.49|-2.55|<0.0001
73999155|NCT01302067|147546944|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.22||0.0005|TWO_SIDED|95.0|-1.22|-0.34||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.34|-1.22|0.0005
73999156|NCT01302067|147546944|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-1.77|-0.71||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.71|-1.77|<0.0001
73999157|NCT01302067|147546945|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
73999158|NCT01302067|147546945|SUPERIORITY_OR_OTHER|||||||0.0348|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0348
73999159|NCT01302067|147546945|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0003
73999160|NCT01302067|147546946|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
73999161|NCT01302067|147546946|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0002
73999162|NCT01302067|147546946|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
73999163|NCT01302067|147546947|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||<0.0001
73999164|NCT01302067|147546947|SUPERIORITY_OR_OTHER|||||||0.0057|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0057
73999165|NCT01302067|147546947|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0008
73999166|NCT01302067|147546948|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0007
73999167|NCT01302067|147546948|SUPERIORITY_OR_OTHER|||||||0.0091|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0091
74036596|NCT03006471|147626522|SUPERIORITY|||||||0.087||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.087
73877066|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||77.5|-77.5|1.000
73999168|NCT01302067|147546948|SUPERIORITY_OR_OTHER|||||||0.3901|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.3901
73999169|NCT01302067|147546949|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.47|STANDARD_ERROR_OF_MEAN|1.54|<|0.0001|TWO_SIDED|95.0|-15.49|-9.45||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-9.45|-15.49|<0.0001
73999170|NCT01302067|147546949|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.69|STANDARD_ERROR_OF_MEAN|1.26||0.0002|TWO_SIDED|95.0|-7.15|-2.22||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-2.22|-7.15|0.0002
73999171|NCT01302067|147546949|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.78|STANDARD_ERROR_OF_MEAN|1.53|<|0.0001|TWO_SIDED|95.0|-10.78|-4.78||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-4.78|-10.78|<0.0001
73999172|NCT01302067|147546950|SUPERIORITY_OR_OTHER||Least squares mean difference|10.46|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|7.2|13.73||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||13.73|7.20|<0.0001
73999173|NCT01302067|147546950|SUPERIORITY_OR_OTHER||Least squares mean difference|4.68|STANDARD_ERROR_OF_MEAN|1.36||0.0006|TWO_SIDED|95.0|2.01|7.36||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||7.36|2.01|0.0006
73999174|NCT01302067|147546950|SUPERIORITY_OR_OTHER||Least squares mean difference|5.78|STANDARD_ERROR_OF_MEAN|1.66||0.0005|TWO_SIDED|95.0|2.53|9.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.03|2.53|0.0005
73999175|NCT01302067|147546951|SUPERIORITY_OR_OTHER||Least squares mean difference|10.91|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|7.73|14.09||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||14.09|7.73|<0.0001
73999176|NCT01302067|147546951|SUPERIORITY_OR_OTHER||Least squares mean difference|4.36|STANDARD_ERROR_OF_MEAN|1.33||0.001|TWO_SIDED|95.0|1.76|6.96||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.96|1.76|0.0010
73999177|NCT01302067|147546951|SUPERIORITY_OR_OTHER||Least squares mean difference|6.55|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED|95.0|3.39|9.72||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.72|3.39|<0.0001
73999178|NCT01302067|147546952|SUPERIORITY_OR_OTHER||Least squares mean difference|7.46|STANDARD_ERROR_OF_MEAN|1.56|<|0.0001|TWO_SIDED|95.0|4.4|10.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||10.51|4.40|<0.0001
73999179|NCT01302067|147546952|SUPERIORITY_OR_OTHER||Least squares mean difference|3.74|STANDARD_ERROR_OF_MEAN|1.27||0.0034|TWO_SIDED|95.0|1.24|6.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.23|1.24|0.0034
73999180|NCT01302067|147546952|SUPERIORITY_OR_OTHER||Least squares mean difference|3.72|STANDARD_ERROR_OF_MEAN|1.55||0.0164|TWO_SIDED|95.0|0.68|6.76||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.76|0.68|0.0164
73999181|NCT01302067|147546953|SUPERIORITY_OR_OTHER||Least squares mean difference|7.5|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|5.03|9.97||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.97|5.03|<0.0001
74036597|NCT03006471|147626522|SUPERIORITY|||||||0.345||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.345
74036598|NCT03006471|147626523|SUPERIORITY|||||||0.115||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention group||||0.115
74036599|NCT03006471|147626524|SUPERIORITY|||||||0.047||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention groups||||0.047
74036600|NCT03006471|147626525|SUPERIORITY|||||||0.539||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention groups||||0.539
74036601|NCT03006471|147626526|SUPERIORITY|||||||0.844||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.844
74036602|NCT03006471|147626526|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.010
74036603|NCT03006471|147626527|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
74090655|NCT02040779|147735342|SUPERIORITY||LSM difference|7.911||||0.0443|TWO_SIDED|95.0|0.202|15.621||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||15.621|0.202|0.0443
74090656|NCT02040779|147735342|SUPERIORITY||LSM difference|13.645||||0.0007|TWO_SIDED|95.0|5.843|21.446||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||21.446|5.843|0.0007
73877067|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|25.0||||0.608|TWO_SIDED|95.0|-20.8|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||70.8|-20.8|0.608
73877068|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||-15.4|-84.6|0.105
73877069|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||77.5|-77.5|1.000
74036604|NCT03006471|147626527|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.011
74036605|NCT03006471|147626528|SUPERIORITY|||||||0.221||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.221
74036606|NCT03006471|147626528|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.001
74036607|NCT03006471|147626529|SUPERIORITY|||||||0.461||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.461
74036608|NCT03006471|147626529|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.011
74036609|NCT03006471|147626530|SUPERIORITY|||||||0.285||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.285
74036610|NCT03006471|147626530|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.002
74036611|NCT03006471|147626531|SUPERIORITY|||||||0.701||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.701
74036612|NCT03006471|147626531|SUPERIORITY|||||||0.081||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.081
74036613|NCT03006471|147626532|SUPERIORITY|||||||0.581||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.581
74036614|NCT03006471|147626532|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-cholesterol on dapagliflozin group||||0.004
73877070|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||49.0|-49.0|1.000
73956874|NCT01362491|147449736|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.03||||0.651|TWO_SIDED|95.0|-0.11|0.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.18|-0.11|0.651
73956875|NCT01362491|147449736|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.62|||<|0.001|TWO_SIDED|95.0|0.42|0.81||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.81|0.42|<0.001
73956876|NCT01362491|147449736|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.65|||<|0.001|TWO_SIDED|95.0|0.46|0.85||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.85|0.46|<0.001
73956877|NCT01362491|147449736|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.03||||0.669|TWO_SIDED|95.0|-0.19|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.19|0.669
73956878|NCT01362491|147449736|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.84|||<|0.001|TWO_SIDED|95.0|0.57|1.11||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.11|0.57|<0.001
73956879|NCT01362491|147449736|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.94|||<|0.001|TWO_SIDED|95.0|0.67|1.21||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.21|0.67|<0.001
73956880|NCT01362491|147449736|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.1||||0.396|TWO_SIDED|95.0|-0.32|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.32|0.396
73956881|NCT01362491|147449737|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.8|||<|0.001|TWO_SIDED|95.0|1.3|2.3||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.30|1.30|<0.001
73956882|NCT01362491|147449737|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.78|||<|0.001|TWO_SIDED|95.0|1.28|2.28||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.28|1.28|<0.001
73999182|NCT01302067|147546953|SUPERIORITY_OR_OTHER||Least squares mean difference|3.68|STANDARD_ERROR_OF_MEAN|1.03||0.0004|TWO_SIDED|95.0|1.65|5.7||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||5.70|1.65|0.0004
74036615|NCT03006471|147626533|SUPERIORITY|||||||0.727||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.727
73956883|NCT01362491|147449737|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.911|TWO_SIDED|95.0|-0.39|0.43||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.43|-0.39|0.911
73956884|NCT01362491|147449737|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.87|||<|0.001|TWO_SIDED|95.0|1.33|2.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.41|1.33|<0.001
73956885|NCT01362491|147449737|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.34|2.42||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.42|1.34|<0.001
74036616|NCT03006471|147626533|SUPERIORITY|||||||0.451||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.451
74036617|NCT03006471|147626534|SUPERIORITY|||||||0.463||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.463
73999183|NCT01302067|147546953|SUPERIORITY_OR_OTHER||Least squares mean difference|3.82|STANDARD_ERROR_OF_MEAN|1.25||0.0023|TWO_SIDED|95.0|1.36|6.28||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.28|1.36|0.0023
73999184|NCT01302067|147546954|SUPERIORITY_OR_OTHER||Least squares mean difference|9.37|STANDARD_ERROR_OF_MEAN|1.43|<|0.0001|TWO_SIDED|95.0|6.56|12.18||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||12.18|6.56|<0.0001
73999185|NCT01302067|147546954|SUPERIORITY_OR_OTHER||Least squares mean difference|4.23|STANDARD_ERROR_OF_MEAN|1.17||0.0003|TWO_SIDED|95.0|1.93|6.53||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.53|1.93|0.0003
73999186|NCT01302067|147546954|SUPERIORITY_OR_OTHER||Least squares mean difference|5.14|STANDARD_ERROR_OF_MEAN|1.43||0.0003|TWO_SIDED|95.0|2.34|7.94||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||7.94|2.34|0.0003
73999187|NCT01302067|147546955|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0016
73999188|NCT01302067|147546955|SUPERIORITY_OR_OTHER|||||||0.8121|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.8121
73999189|NCT01302067|147546955|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0015
73999190|NCT01302067|147546956|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||<0.0001
73999191|NCT01302067|147546956|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0006
73999192|NCT01302067|147546956|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0027
73999193|NCT00266227|147546962|SUPERIORITY_OR_OTHER|||||||0.0195|||||||Cochran-Mantel-Haenszel|||||||0.0195
73999194|NCT00266227|147546964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||||95.0|-0.7|-0.1|||ANOVA|Adjusted mean for Arm A (Rituxan) is -1.9 and adjusted mean for Arm B (Placebo) is -1.5.||Assessed using an analysis of variance (ANOVA) model, with retreatment group, baseline DAS28-ESR score, baseline RF status, and ≥20% improvement in both SJC and TJC at Week 24 from baseline (yes/no) as explanatory terms in the model.||-0.1|-0.7|
73999195|NCT00435591|147547011|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|||||TWO_SIDED|95.0|-0.37|0.83||||||"Aggregated data were used to determine differences between groups. Statistical analysis is relevant to the aggregated data of all rows except the no assessment row."||0.83|-0.37|
73999196|NCT00210470|147547018|EQUIVALENCE|The correlation of each of the above variables at biopsy/Day 1, surgery/Day 21, and change with percent change in the longest diameter (LD) of the primary tumor was calculated using Spearman rank correlations (183 correlations). Due to outliers in the distribution of percent change in the longest diameter, it was felt that the Spearman rank correlations would be more appropriate than Pearson correlations.|||||<|0.1|||||||Spearman Rank|||||||<0.10
73999197|NCT02245737|147547044|SUPERIORITY||LS Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.77||0.232|TWO_SIDED|95.0|-2.447|0.594|||Mixed Models Analysis|||||0.594|-2.447|0.232
73999198|NCT02245737|147547044|SUPERIORITY||LS Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.78||0.599|TWO_SIDED|95.0|-1.124|1.947|||Mixed Models Analysis|||||1.947|-1.124|0.599
73999199|NCT02245737|147547045|SUPERIORITY||LS Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.83||0.971|TWO_SIDED|95.0|-1.609|1.669|||Mixed Models Analysis|||||1.669|-1.609|0.971
73999200|NCT02245737|147547045|SUPERIORITY||LS Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.85||0.923|TWO_SIDED|95.0|-1.58|1.743|||Mixed Models Analysis|||||1.743|-1.580|0.923
73999201|NCT02245737|147547046|SUPERIORITY||LS Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.53||0.796|TWO_SIDED|95.0|-1.172|0.899|||Mixed Models Analysis|||||0.899|-1.172|0.796
73999202|NCT02245737|147547046|SUPERIORITY||LS Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.53||0.252|TWO_SIDED|95.0|-0.437|1.66|||Mixed Models Analysis|||||1.660|-0.437|0.252
73999203|NCT02245737|147547047|SUPERIORITY||LS Mean Difference (Final Values)|1.11|STANDARD_ERROR_OF_MEAN|1.4||0.428|TWO_SIDED|95.0|-1.637|3.852|||Mixed Models Analysis|||||3.852|-1.637|0.428
73999204|NCT02245737|147547047|SUPERIORITY||LS Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.42||0.926|TWO_SIDED|95.0|-2.918|2.655|||Mixed Models Analysis|||||2.655|-2.918|0.926
73999205|NCT02245737|147547048|SUPERIORITY||LS Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.24||0.533|TWO_SIDED|95.0|-0.322|0.622|||Mixed Models Analysis|||||0.622|-0.322|0.533
73999206|NCT02245737|147547048|SUPERIORITY||LS Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.24||0.537|TWO_SIDED|95.0|-0.328|0.63|||Mixed Models Analysis|||||0.630|-0.328|0.537
73999207|NCT02245737|147547050|SUPERIORITY||LS Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|1.13||0.116|TWO_SIDED|95.0|-0.441|3.986|||Mixed Models Analysis|||||3.986|-0.441|0.116
73999208|NCT02245737|147547050|SUPERIORITY||LS Mean Difference (Final Values)|1.45|STANDARD_ERROR_OF_MEAN|1.15||0.208|TWO_SIDED|95.0|-0.808|3.704|||Mixed Models Analysis|||||3.704|-0.808|0.208
73877071|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-30.0||||0.565|TWO_SIDED|95.0|-79.3|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||19.3|-79.3|0.565
73877072|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|50.0||||0.467|TWO_SIDED|95.0|15.4|84.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||84.6|15.4|0.467
73877073|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||49.0|-49.0|1.000
73877074|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-15.4|-84.6|0.105
73877075|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-64.5|89.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||89.5|-64.5|1.000
73877076|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.7|-35.7|1.000
73999209|NCT02245737|147547051|SUPERIORITY||LS Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.36||0.379|TWO_SIDED|95.0|-0.391|1.027|||Mixed Models Analysis|||||1.027|-0.391|0.379
73999210|NCT02245737|147547051|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.992|TWO_SIDED|95.0|-0.714|0.721|||Mixed Models Analysis|||||0.721|-0.714|0.992
73999211|NCT02245737|147547052|SUPERIORITY||LS Mean Difference (Final Values)|-51.27|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-56.963|-45.578|||ANCOVA|||||-45.578|-56.963|<0.001
73999212|NCT02245737|147547052|SUPERIORITY||LS Mean Difference (Final Values)|-65.48|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-70.947|-60.022|||ANCOVA|||||-60.022|-70.947|<0.001
73877077|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.0|-66.0|1.000
73877078|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|50.0||||0.467|TWO_SIDED|95.0|15.4|84.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||84.6|15.4|0.467
73877079|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||60.7|-35.7|1.000
73877080|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||-15.4|-84.6|0.105
73999213|NCT02245737|147547053|SUPERIORITY||LS Mean Difference (Final Values)|-57.99|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-62.865|-53.108|||ANCOVA|||||-53.108|-62.865|<0.001
73999214|NCT02245737|147547053|SUPERIORITY||LS Mean Difference (Final Values)|-73.25|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-77.926|-68.575|||ANCOVA|||||-68.575|-77.926|<0.001
73999215|NCT02245737|147547054|SUPERIORITY||LS Mean Difference (Final Values)|-19.87|STANDARD_ERROR_OF_MEAN|11.33||0.081|TWO_SIDED|95.0|-42.21|2.464|||ANCOVA|||||2.464|-42.210|0.081
73999216|NCT02245737|147547054|SUPERIORITY||LS Mean Difference (Final Values)|-15.31|STANDARD_ERROR_OF_MEAN|10.78||0.157|TWO_SIDED|95.0|-36.555|5.938|||ANCOVA|||||5.938|-36.555|0.157
73999217|NCT02245737|147547055|SUPERIORITY||LS Mean Difference (Final Values)|-2.62|STANDARD_ERROR_OF_MEAN|1.33||0.05|TWO_SIDED|95.0|-5.243|-0.002|||ANCOVA|||||-0.002|-5.243|0.050
73999218|NCT02245737|147547055|SUPERIORITY||LS Mean Difference (Final Values)|-2.12|STANDARD_ERROR_OF_MEAN|1.27||0.095|TWO_SIDED|95.0|-4.618|0.373|||ANCOVA|||||0.373|-4.618|0.095
73999219|NCT02245737|147547056|SUPERIORITY||LS Mean Difference (Final Values)|-13.68|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-18.785|-8.574|||ANCOVA|||||-8.574|-18.785|<0.001
73999220|NCT02245737|147547056|SUPERIORITY||LS Mean Difference (Final Values)|-17.66|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-22.887|-12.428|||ANCOVA|||||-12.428|-22.887|<0.001
73999221|NCT02245737|147547057|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.426|TWO_SIDED|95.0|-0.033|0.014|||ANCOVA|||||0.014|-0.033|0.426
73999222|NCT02245737|147547057|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.66|TWO_SIDED|95.0|-0.029|0.018|||ANCOVA|||||0.018|-0.029|0.660
73999223|NCT02245737|147547058|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.0||0.21|TWO_SIDED|95.0|-0.015|0.003|||ANCOVA|||||0.003|-0.015|0.210
73877081|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||72.9|-19.6|0.249
73999224|NCT02245737|147547058|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.568|TWO_SIDED|95.0|-0.013|0.007|||ANCOVA|||||0.007|-0.013|0.568
73999225|NCT02245737|147547059|SUPERIORITY||LS Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-3.258|-1.413|||ANCOVA|||||-1.413|-3.258|<0.001
73999226|NCT02245737|147547059|SUPERIORITY||LS Mean Difference (Final Values)|-3.18|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-4.118|-2.247|||ANCOVA|||||-2.247|-4.118|<0.001
73999227|NCT02366468|147547063|NON_INFERIORITY|non-inferiority margin: -4 letters|Median Difference (Final Values)|-0.9||||0.002|TWO_SIDED|95.0|-3.04|1.27|||ANCOVA|including study treatment (DI, PRN) and center as factors and baseline BCVA as continuous covariate.||The primary objective was to demonstrate that the mean visit-averaged change from baseline of BCVA over month 1 to treatment completion for the DI arm was non-inferior to the PRN arm.||1.27|-3.04|0.002
73999228|NCT02366468|147547067|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.62|TWO_SIDED|95.0|-17.1|28.56|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates||||28.56|-17.10|0.620
73999229|NCT02366468|147547068|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.925|TWO_SIDED|95.0|-33.66|30.59|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates||||30.59|-33.66|0.925
73999230|NCT04797650|147547076|SUPERIORITY||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.25|0.37||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.37|0.25|<0.0001
73999231|NCT04797650|147547076|SUPERIORITY||Risk Difference (RD)|0.36|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.27|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.45|0.27|<0.0001
73999232|NCT04797650|147547077|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.31|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.46|0.31|<0.0001
73999233|NCT04797650|147547077|SUPERIORITY||Risk Difference (RD)|0.36|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.26|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.45|0.26|<0.0001
73999234|NCT04797650|147547077|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.3|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.45|0.30|<0.0001
73999235|NCT04797650|147547077|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.31|0.5||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.50|0.31|<0.0001
73999236|NCT04797650|147547077|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.32|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.46|0.32|<0.0001
73999237|NCT04797650|147547077|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|0.41|0.59||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.59|0.41|<0.0001
73999238|NCT04797650|147547077|SUPERIORITY||Risk Difference (RD)|0.45|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.38|0.52||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.52|0.38|<0.0001
73999239|NCT04797650|147547077|SUPERIORITY||Risk Difference (RD)|0.49|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|0.4|0.58||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.58|0.40|<0.0001
73999240|NCT04797650|147547078|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.004||0.3175|TWO_SIDED|95.0|0.0|0.01||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 4||0.01|-0.00|0.3175
73999241|NCT04797650|147547078|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.102|TWO_SIDED|95.0|0.0|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|-0.00|0.1020
73999242|NCT04797650|147547078|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.3103|TWO_SIDED|95.0|-0.01|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|-0.01|0.3103
73999243|NCT04797650|147547078|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.14|0.06|<0.0001
73999244|NCT04797650|147547078|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.06|0.17||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.17|0.06|<0.0001
73877082|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||18.2|-28.2|1.000
73999245|NCT04797650|147547078|SUPERIORITY||Risk Difference (RD)|0.19|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.14|0.24||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.24|0.14|<0.0001
73999246|NCT04797650|147547078|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.13|0.27||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.27|0.13|<0.0001
73999247|NCT04797650|147547078|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.18|0.29||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo|Mantel Haenszel|||Week 20||0.29|0.18|<0.0001
73999248|NCT04797650|147547078|SUPERIORITY||Risk Difference (RD)|0.27|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.19|0.35||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.35|0.19|<0.0001
73999249|NCT04797650|147547079|SUPERIORITY||Least Square (LS) Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.97||0.0039|TWO_SIDED|95.0|-4.7|-0.9||P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-0.9|-4.7|0.0039
73999250|NCT04797650|147547079|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.12||0.0027|TWO_SIDED|95.0|-5.6|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-1.2|-5.6|0.0027
74036618|NCT03006471|147626534|SUPERIORITY|||||||0.043||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.043
73877083|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-13.3||||0.511|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.511
73877084|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|33.3||||0.14|TWO_SIDED|95.0|-11.4|78.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||78.1|-11.4|0.140
73877085|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|10.0||||0.569|TWO_SIDED|95.0|-14.6|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||34.6|-14.6|0.569
73999251|NCT04797650|147547079|SUPERIORITY||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|2.15|<|0.0001|TWO_SIDED|95.0|-13.6|-5.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-5.1|-13.6|<0.0001
73999252|NCT04797650|147547079|SUPERIORITY||LS Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|2.47|<|0.0001|TWO_SIDED|95.0|-19.0|-9.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-9.3|-19|<0.0001
73999253|NCT04797650|147547079|SUPERIORITY||LS Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|2.92|<|0.0001|TWO_SIDED|95.0|-28.8|-17.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-17.3|-28.8|<0.0001
73999254|NCT04797650|147547079|SUPERIORITY||LS Mean Difference|-29.3|STANDARD_ERROR_OF_MEAN|3.36|<|0.0001|TWO_SIDED|95.0|-35.9|-22.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-22.7|-35.9|< 0.0001
73999255|NCT04797650|147547079|SUPERIORITY||LS Mean Difference|-34.8|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|95.0|-41.4|-28.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-28.2|-41.4|< 0.0001
73999256|NCT04797650|147547079|SUPERIORITY||LS Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|3.86|<|0.0001|TWO_SIDED|95.0|-47.8|-32.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-32.6|-47.8|< 0.0001
73999257|NCT04797650|147547079|SUPERIORITY||LS Mean Difference|-38.7|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|95.0|-45.9|-31.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-31.6|-45.9|< 0.0001
73999258|NCT04797650|147547079|SUPERIORITY||LS Mean Difference|-46.6|STANDARD_ERROR_OF_MEAN|4.17|<|0.0001|TWO_SIDED|95.0|-54.8|-38.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-38.4|-54.8|< 0.0001
73999259|NCT04797650|147547079|SUPERIORITY||LS Mean Difference|-45.9|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-53.4|-38.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-38.5|-53.4|< 0.0001
73999260|NCT04797650|147547079|SUPERIORITY||LS Mean Difference|-52.8|STANDARD_ERROR_OF_MEAN|4.36|<|0.0001|TWO_SIDED|95.0|-61.4|-44.2|||MMRM|||Week 24||-44.2|-61.4|< 0.0001
74036619|NCT03006471|147626535|SUPERIORITY|||||||0.807||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.807
73877086|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.5|-19.7|1.000
73877087|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||72.9|-19.6|0.249
73877088|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||18.2|-28.2|1.000
73956886|NCT01362491|147449737|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.0||||0.982|TWO_SIDED|95.0|-0.45|0.44||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.44|-0.45|0.982
73956887|NCT01362491|147449737|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.44|||<|0.001|TWO_SIDED|95.0|1.72|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.15|1.72|<0.001
73956888|NCT01362491|147449737|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.61|||<|0.001|TWO_SIDED|95.0|1.9|3.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.33|1.90|<0.001
73956889|NCT01362491|147449737|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.18||||0.547|TWO_SIDED|95.0|-0.77|0.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.41|-0.77|0.547
73956890|NCT01362491|147449738|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.16|||<|0.001|TWO_SIDED|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.83|<0.001
73956891|NCT01362491|147449738|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.83|<0.001
73956892|NCT01362491|147449738|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.0||||0.992|TWO_SIDED|95.0|-0.28|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.27|-0.28|0.992
73956893|NCT01362491|147449738|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.01|||<|0.001|TWO_SIDED|95.0|1.43|2.58||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.58|1.43|<0.001
73999261|NCT04797650|147547080|SUPERIORITY||||||<|0.0001||||||P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
73956894|NCT01362491|147449738|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.68||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.68|1.53|<0.001
73956895|NCT01362491|147449738|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.1||||0.684|TWO_SIDED|95.0|-0.57|0.38||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.38|-0.57|0.684
73956896|NCT01362491|147449739|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.51|||<|0.001|TWO_SIDED|95.0|1.85|3.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.17|1.85|<0.001
73999262|NCT04797650|147547080|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
73999263|NCT04797650|147547080|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
73877089|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-2.2||||1|TWO_SIDED|95.0|-29.0|24.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||24.6|-29.0|1.000
73999264|NCT04797650|147547080|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
73999265|NCT04797650|147547080|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
73999266|NCT04797650|147547080|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
73999267|NCT04797650|147547080|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
73999268|NCT04797650|147547080|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
73999269|NCT04797650|147547081|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
73999270|NCT04797650|147547081|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
74036620|NCT03006471|147626535|SUPERIORITY|||||||0.754||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.754
73877090|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|13.3||||0.613|TWO_SIDED|95.0|-35.1|61.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||61.8|-35.1|0.613
73999271|NCT04797650|147547081|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
73999272|NCT04797650|147547081|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
73999273|NCT04797650|147547081|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
73999274|NCT04797650|147547081|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
73999275|NCT04797650|147547081|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
73999276|NCT04797650|147547081|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
73999277|NCT04797650|147547082|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1|-1.5|< 0.0001
73999278|NCT04797650|147547082|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1.1|-1.7|< 0.0001
73999279|NCT04797650|147547082|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.3|-1.9|< 0.0001
73999280|NCT04797650|147547082|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.2|-1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.5|-2.2|< 0.0001
73999281|NCT04797650|147547082|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.3|-2|< 0.0001
73999282|NCT04797650|147547082|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.7|-2.5|< 0.0001
73999283|NCT04797650|147547082|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.5|-1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.5|< 0.0001
74036621|NCT03006471|147626536|SUPERIORITY|||||||0.507||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.507
73999284|NCT04797650|147547082|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-2.8|-2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-2|-2.8|< 0.0001
73999285|NCT04797650|147547083|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.8|-1.0||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1|-1.8|< 0.0001
73999286|NCT04797650|147547083|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1.1|-2|< 0.0001
73999287|NCT04797650|147547083|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.0|-1.2||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.2|-2|< 0.0001
73999288|NCT04797650|147547083|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-2.3|-1.4||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.4|-2.3|< 0.0001
73999289|NCT04797650|147547083|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-2.2|-1.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.3|-2.2|< 0.0001
73999290|NCT04797650|147547083|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.4|-1.5||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.5|-2.4|< 0.0001
73999291|NCT04797650|147547083|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.7|-2.5|< 0.0001
73999292|NCT04797650|147547083|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.8|-1.8||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.8|< 0.0001
74090657|NCT02040779|147735343|SUPERIORITY||LSM difference|5.405||||0.2014|TWO_SIDED|95.0|-2.905|13.715||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||13.715|-2.905|0.2014
73999293|NCT04797650|147547084|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.05|0.12||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.12|0.05|< 0.0001
73999294|NCT04797650|147547084|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.06|0.17||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.17|0.06|< 0.0001
73999295|NCT04797650|147547084|SUPERIORITY||Risk Difference (RD)|0.33|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.27|0.38||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.38|0.27|< 0.0001
73999296|NCT04797650|147547084|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.28|0.45||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.45|0.28|< 0.0001
73999297|NCT04797650|147547084|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.0409|TWO_SIDED|95.0|0.0|0.03||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.03|0.00|0.0409
73999298|NCT04797650|147547084|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.012|TWO_SIDED|95.0|0.01|0.09||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.09|0.01|0.012
73999299|NCT04797650|147547084|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.16|0.26||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.26|0.16|< 0.0001
73999300|NCT04797650|147547084|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.16|0.31||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.31|0.16|< 0.0001
73999301|NCT04797650|147547085|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|0.7|1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.4|0.7|< 0.0001
73999302|NCT04797650|147547085|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.7|1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.5|0.7|< 0.0001
73999303|NCT04797650|147547085|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|1.1|1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||1.8|1.1|< 0.0001
73999304|NCT04797650|147547085|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|1.3|2.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.2|1.3|< 0.0001
73999305|NCT04797650|147547086|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.7|1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.5|0.7|< 0.0001
73999306|NCT04797650|147547086|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|0.7|1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.6|0.7|< 0.0001
73999307|NCT04797650|147547086|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.0|2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2|1|< 0.0001
73999308|NCT04797650|147547086|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|1.0|2.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.1|1|< 0.0001
73999309|NCT04797650|147547087|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.9|-1.4|< 0.0001
73999310|NCT04797650|147547087|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.9|-1.5|< 0.0001
73999311|NCT04797650|147547087|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.1|-1.6|< 0.0001
73999312|NCT04797650|147547087|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.2|-1.8|< 0.0001
73999313|NCT04797650|147547087|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.1|-1.6|< 0.0001
73999314|NCT04797650|147547087|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-2.0|-1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.4|-2|< 0.0001
73999315|NCT04797650|147547087|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.3|-1.8|< 0.0001
73999316|NCT04797650|147547087|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-2.1|-1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.4|-2.1|< 0.0001
73999317|NCT04797650|147547088|SUPERIORITY||Risk Difference (RD)|0.34|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|95.0|0.25|0.43||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.43|0.25|< 0.0001
73999318|NCT04797650|147547088|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|0.33|0.54||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.54|0.33|< 0.0001
73999319|NCT04797650|147547088|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.35|0.51||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.51|0.35|< 0.0001
73999320|NCT04797650|147547088|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.37|0.57||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.57|0.37|< 0.0001
73999321|NCT04797650|147547088|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.34|0.5||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.5|0.34|< 0.0001
73999322|NCT04797650|147547088|SUPERIORITY||Risk Difference (RD)|0.54|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.44|0.63||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.63|0.44|< 0.0001
73999323|NCT04797650|147547088|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.36|0.52||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.52|0.36|< 0.0001
73999324|NCT04797650|147547088|SUPERIORITY||Risk Difference (RD)|0.52|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.42|0.62||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.62|0.42|< 0.0001
73999325|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.8|-1.2|< 0.0001
74036622|NCT03006471|147626536|SUPERIORITY|||||||0.015||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.015
73999326|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.8|-1.4|< 0.0001
73999327|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-0.9|-1.3|< 0.0001
73999328|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-1.1|-1.6|< 0.0001
73999329|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1|-1.5|< 0.0001
73999330|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1.3|-1.9|< 0.0001
73999331|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.1|-1.6|< 0.0001
73999332|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.2|-1.8|< 0.0001
73999333|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 12||-0.7|-1.1|< 0.0001
73999334|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 12||-0.8|-1.3|< 0.0001
74036623|NCT03006471|147626537|SUPERIORITY|||||||0.039||||||The threshold for statistical significance was p=0.05|Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.039
73999335|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 16||-0.7|-1.2|< 0.0001
73999336|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 16||-0.9|-1.4|< 0.0001
73999337|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 20||-0.9|-1.3|< 0.0001
73999338|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 20||-1.1|-1.6|< 0.0001
73999339|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 24||-1.0|-1.5|< 0.0001
73999340|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 24||-1.2|-1.8|< 0.0001
73999341|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 12||-0.8|-1.3|< 0.0001
74036624|NCT03006471|147626538|SUPERIORITY|||||||0.011|||||||Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.011
73999342|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 12||-0.8|-1.4|< 0.0001
73999343|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 16||-0.8|-1.3|< 0.0001
73999344|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 16||-1|-1.6|< 0.0001
73999345|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 20||-1.0|-1.5|< 0.0001
73999346|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 20||-1.1|-1.7|< 0.0001
73999347|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 24||-1.0|-1.5|< 0.0001
73999348|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 24||-1.2|-1.8|< 0.0001
73999349|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 12||-0.7|-1.1|< 0.0001
73999350|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 12||-0.7|-1.2|< 0.0001
73999351|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 16||-0.7|-1.2|< 0.0001
73999352|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 16||-0.8|-1.3|< 0.0001
73999353|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 20||-0.8|-1.3|< 0.0001
74036625|NCT03006471|147626539|SUPERIORITY|||||||0.096||||||The threshold for statistical significance was p=0.05|Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.096
73999354|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 20||-1.0|-1.5|< 0.0001
73999355|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 24||-0.9|-1.4|< 0.0001
73999356|NCT04797650|147547089|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 24||-1.1|-1.6|< 0.0001
73999357|NCT04797650|147547090|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.29||0.1206|TWO_SIDED|95.0|-0.1|1.0||P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||1.0|-0.1|0.1206
73999358|NCT04797650|147547090|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.34||0.5367|TWO_SIDED|95.0|-0.5|0.9||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||0.9|-0.5|0.5367
73999359|NCT04797650|147547090|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.29||0.0064|TWO_SIDED|95.0|0.2|1.3||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||1.3|0.2|0.0064
73999360|NCT04797650|147547090|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.33||0.0011|TWO_SIDED|95.0|0.4|1.7||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||1.7|0.4|0.0011
73999361|NCT04797650|147547091|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.19|0.3||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.3|0.19|< 0.0001
74039816|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.72|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.72|0.0002
73999362|NCT04797650|147547091|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.18|0.33||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.33|0.18|< 0.0001
73999363|NCT00105001|147547113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.09
73999364|NCT00105001|147547113|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69||||0.1|TWO_SIDED|95.0|0.4|1.1|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-u\[|||1.1|0.4|0.10
73999365|NCT00105001|147547113|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62||||0.04|TWO_SIDED|95.0|0.6|1.0|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up|||1.0|0.6|0.04
73999366|NCT00105001|147547114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.55
73999367|NCT00105001|147547115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.009
73999368|NCT00105001|147547115|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.51|TWO_SIDED|95.0|0.5|1.4|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-up|||1.4|0.5|0.51
73999369|NCT00105001|147547115|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.004|TWO_SIDED|95.0|0.3|0.8|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up|||0.8|0.3|0.004
74036626|NCT02370498|147626586|OTHER||Hazard Ratio (HR)|1.27||||0.98358|TWO_SIDED|95.0|1.03|1.57||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\< 6 months vs. \>= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.57|1.03|0.98358
73999370|NCT00105001|147547116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.93
73999371|NCT00105001|147547117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.96
74039817|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.79|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-0.79|<.0001
73999372|NCT02015455|147547176|SUPERIORITY||Percent Difference in Median|-0.7||||0.54|TWO_SIDED|95.0|-2.9|1.5|||Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, and site time trends. Random effects for clinic and provider.|Percent difference in median of the intervention group with respect to the control group.|||1.5|-2.9|0.54
73999373|NCT02015455|147547177|SUPERIORITY||Odds Ratio (OR)|0.95||||0.04|TWO_SIDED|95.0|0.91|1.0||A p-value \<0.05 was considered significant.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||1.00|0.91|0.04
73999374|NCT02015455|147547178|SUPERIORITY||Odds Ratio (OR)|0.95||||0.02|TWO_SIDED|95.0|0.9|0.99||The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||0.99|0.90|0.02
73999375|NCT02015455|147547179|SUPERIORITY||Odds Ratio (OR)|0.95||||0.02|TWO_SIDED|95.0|0.91|0.99||The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||0.99|0.91|0.02
73999376|NCT02015455|147547183|SUPERIORITY||Odds Ratio (OR)|0.99||||0.74|TWO_SIDED|95.0|0.91|1.07||Statistical significance defined as P\<0.05|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||1.07|0.91|0.74
73999377|NCT02029872|147547189|OTHER|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.||||||||||||||||Due to low enrollment in the intervention, statistical analysis was not possible.|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.|||
73999378|NCT03412747|147547190|NON_INFERIORITY|The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.|Risk Difference (RD)|39.3|||||TWO_SIDED|95.0|30.9|47.7||||||Risk Difference: BKZ-ADA calculated using stratified CMH.||47.7|30.9|
73999379|NCT03412747|147547190|SUPERIORITY||Odds Ratio (OR)|7.459|||<|0.001|TWO_SIDED|95.0|4.709|11.816||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||11.816|4.709|<0.001
73999380|NCT03412747|147547191|NON_INFERIORITY|The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.|Risk Difference (RD)|28.2|||||TWO_SIDED|95.0|19.7|36.7||||||Risk Difference: BKZ-ADA calculated using stratified CMH.||36.7|19.7|
73999381|NCT03412747|147547191|SUPERIORITY||Odds Ratio (OR)|4.341|||<|0.001|TWO_SIDED|95.0|2.785|6.765||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||6.765|2.785|<0.001
73999382|NCT03412747|147547192|SUPERIORITY||Odds Ratio (OR)|6.231|||<|0.001|TWO_SIDED|95.0|3.515|11.046||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||11.046|3.515|<0.001
73999383|NCT03412747|147547192|SUPERIORITY||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|3.657|9.041||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||9.041|3.657|<0.001
73999384|NCT03412747|147547193|SUPERIORITY||Odds Ratio (OR)|4.724|||<|0.001|TWO_SIDED|95.0|2.683|8.318||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||8.318|2.683|<0.001
73999385|NCT03412747|147547193|SUPERIORITY||Odds Ratio (OR)|4.762|||<|0.001|TWO_SIDED|95.0|3.014|7.523||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||7.523|3.014|<0.001
73999386|NCT03412747|147547194|SUPERIORITY||Odds Ratio (OR)|7.103|||<|0.001|TWO_SIDED|95.0|4.637|10.88||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||10.880|4.637|<0.001
73999387|NCT03412747|147547195|SUPERIORITY||Odds Ratio (OR)|4.974|||<|0.001|TWO_SIDED|95.0|3.23|7.661||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||7.661|3.230|<0.001
73999388|NCT03412747|147547196|SUPERIORITY||Odds Ratio (OR)|5.249|||<|0.001|TWO_SIDED|95.0|3.207|8.593||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||8.593|3.207|<0.001
73999389|NCT03412747|147547196|SUPERIORITY||Odds Ratio (OR)|4.974|||<|0.001|TWO_SIDED|95.0|3.257|7.594||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||7.594|3.257|<0.001
73999390|NCT02081417|147547205|NON_INFERIORITY|Based on the PCL-C if the interventions fell within 2.5 points of each other|Mean Difference (Net)|0.18||||0.01|TWO_SIDED|95.0|-3.4|3.8|||Mixed Models Analysis|||||3.8|-3.4|0.01
73999391|NCT01151410|147547271|NON_INFERIORITY_OR_EQUIVALENCE|Indicates statistical significance at 0.025 level for one sided non-inferiority testing at 4mmHg margin.|Mean Difference (Net)|0.31||||0.004|ONE_SIDED|95.0|-2.4||||ANCOVA||||||-2.40|0.0040
73999392|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.157||0.083||||||Significance was set at p \<0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glu/Cr posterior insula||||0.083
73999393|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.436||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glu/Cr posterior insula||||0.436
73999394|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.306||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr posterior insula||||0.306
73999395|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr posterior insula||||0.809
73999396|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.116|STANDARD_DEVIATION|0.177||0.016|||||||t-test, 2 sided|Significance was set at p \<0.05.|Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula||||0.016
74039818|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0193|TWO_SIDED|95.0|-0.5|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.50|0.0193
73999397|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.029|STANDARD_DEVIATION|0.308||0.708||||||Significance was set at p \<0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula||||0.708
73999398|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0||||Significance was set at p \<0.050.|t-test, 2 sided|||Glu/Cr anterior insula||||0.809
73999399|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glu/Cr anterior insula||||0.154
73999400|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr anterior insula||||0.960
73999401|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.937||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr anterior insula||||0.937
73999402|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.897||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glx/Cr anterior insula||||0.897
73999403|NCT00760474|147547278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.309||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glx/Cr anterior insula||||0.309
73999404|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.032||||0.6347|TWO_SIDED|95.0|-0.1081|0.1714||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Anterior Cingulate||0.1714|-0.1081|0.6347
73999405|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.079||||0.5181|TWO_SIDED|95.0|-0.3356|0.1771||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA22||0.1771|-0.3356|0.5181
73877091|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-34.8|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||31.5|-34.8|1.000
73877092|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-15.6||||0.615|TWO_SIDED|95.0|-45.9|14.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.8|-45.9|0.615
73877093|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|20.0||||0.56|TWO_SIDED|95.0|-27.5|67.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||67.5|-27.5|0.560
73877094|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-26.8|36.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Non-responders, Week 52||36.8|-26.8|1.000
73877095|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-8.9||||1|TWO_SIDED|95.0|-37.7|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||19.9|-37.7|1.000
73877096|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.1|-37.1|1.000
73877097|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|10.0||||0.588|TWO_SIDED|95.0|-26.1|46.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||46.1|-26.1|0.588
74036627|NCT02370498|147626587|OTHER||Hazard Ratio (HR)|0.82||||0.04205|TWO_SIDED|95.0|0.66|1.03||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\< 6 months vs. \>= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.03|0.66|0.04205
74036628|NCT02370498|147626588|OTHER||Hazard Ratio (HR)|1.49||||0.99999|TWO_SIDED|95.0|1.25|1.77||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.77|1.25|0.99999
73877098|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-40.0||||0.058|TWO_SIDED|95.0|-64.8|-15.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||-15.2|-64.8|0.058
74090658|NCT02040779|147735343|SUPERIORITY||LSM difference|10.902||||0.0112|TWO_SIDED|95.0|2.5|19.303||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||19.303|2.500|0.0112
73877099|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|16.7||||0.631|TWO_SIDED|95.0|-29.9|63.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||63.2|-29.9|0.631
73877100|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|9.5||||0.597|TWO_SIDED|95.0|-25.7|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||44.8|-25.7|0.597
73877101|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-8.3||||1|TWO_SIDED|95.0|-46.7|30.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||30.0|-46.7|1.000
73877102|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|26.7||||0.361|TWO_SIDED|95.0|-18.5|71.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||71.8|-18.5|0.361
73999406|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.072||||0.2987|TWO_SIDED|95.0|-0.2161|0.0714||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA40||0.0714|-0.2161|0.2987
73999407|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.029||||0.5151|TWO_SIDED|95.0|-0.064|0.1219||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_anIns||0.1219|-0.0640|0.5151
73999408|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.081||||0.2369|TWO_SIDED|95.0|-0.2228|0.0599||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Amygdala||0.0599|-0.2228|0.2369
73999409|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.077||||0.0758|TWO_SIDED|95.0|-0.1642|0.0092||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Cerebellum||0.0092|-0.1642|0.0758
73999410|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.025||||0.4609|TWO_SIDED|95.0|-0.0947|0.0452||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_DLPFC||0.0452|-0.0947|0.4609
73999411|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.111||||0.3813|TWO_SIDED|95.0|-0.3745|0.1524||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Mid Insula||0.1524|-0.3745|0.3813
73999412|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.02||||0.72|TWO_SIDED|95.0|-0.0964|0.1361||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Mid Temporal Pole||0.1361|-0.0964|0.7200
73999413|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.168||||0.2099|TWO_SIDED|95.0|-0.1065|0.4434||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Orbito Front||0.4434|-0.1065|0.2099
73999414|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.003||||0.9551|TWO_SIDED|95.0|-0.1047|0.0992||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||PAG||0.0992|-0.1047|0.9551
73999415|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.0855|0.0848||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Posterior Insula||0.0848|-0.0855|0.9940
73999416|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.049||||0.4291|TWO_SIDED|95.0|-0.1792|0.0806||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Posterior Cingulate||0.0806|-0.1792|0.4291
73999417|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.027||||0.467|TWO_SIDED|95.0|-0.0496|0.1028||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Precuneus||0.1028|-0.0496|0.4670
73999418|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.044||||0.4443|TWO_SIDED|95.0|-0.0752|0.1624||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Putamen||0.1624|-0.0752|0.4443
74036629|NCT02370498|147626589|OTHER||Hazard Ratio (HR)|0.94||||0.24463|TWO_SIDED|95.0|0.79|1.12||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.12|0.79|0.24463
73999419|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.127||||0.2823|TWO_SIDED|95.0|-0.3704|0.1165||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_S2||0.1165|-0.3704|0.2823
73999420|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.105||||0.1369|TWO_SIDED|95.0|-0.2481|0.0378||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_DLPFC||0.0378|-0.2481|0.1369
73999421|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.078||||0.2376|TWO_SIDED|95.0|-0.0573|0.2127||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_anIns||0.2127|-0.0573|0.2376
73999422|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.153||||0.0968|TWO_SIDED|95.0|-0.3365|0.0313||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Amygdala||0.0313|-0.3365|0.0968
73999423|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.023||||0.572|TWO_SIDED|95.0|-0.061|0.1062||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_BA23\_base||0.1062|-0.0610|0.5720
73999424|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.027||||0.5822|TWO_SIDED|95.0|-0.1303|0.0761||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_IPL\_base||0.0761|-0.1303|0.5822
74036630|NCT02370498|147626590|OTHER||Hazard Ratio (HR)|0.98||||0.41331|TWO_SIDED|95.0|0.79|1.21||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.21|0.79|0.41331
74036631|NCT02370498|147626591|OTHER||Hazard Ratio (HR)|1.19||||0.97481|TWO_SIDED|95.0|1.0|1.42||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.42|1.00|0.97481
73877103|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-4.3||||0.812|TWO_SIDED|95.0|-39.6|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||31.0|-39.6|0.812
73999425|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.044||||0.6851|TWO_SIDED|95.0|-0.2697|0.1824||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Insula\_base||0.1824|-0.2697|0.6851
73999426|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.013||||0.8656|TWO_SIDED|95.0|-0.1699|0.1446||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Insula||0.1446|-0.1699|0.8656
73999427|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.094||||0.1562|TWO_SIDED|95.0|-0.2296|0.0407||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Front\_DLPFC||0.0407|-0.2296|0.1562
73999428|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.012||||0.7752|TWO_SIDED|95.0|-0.0991|0.0754||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Temporal Pole||0.0754|-0.0991|0.7752
73999429|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.01||||0.9182|TWO_SIDED|95.0|-0.1912|0.2109||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Orbito Front||0.2109|-0.1912|0.9182
73999430|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.022||||0.6544|TWO_SIDED|95.0|-0.0829|0.1278||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_PAG||0.1278|-0.0829|0.6544
73999431|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.087||||0.0813|TWO_SIDED|95.0|-0.0123|0.1863||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_pIns||0.1863|-0.0123|0.0813
73999432|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.052||||0.4605|TWO_SIDED|95.0|-0.0956|0.2004||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_pIns||0.2004|-0.0956|0.4605
73999433|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.081||||0.3136|TWO_SIDED|95.0|-0.2484|0.0856||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Posterior Cingulate||0.0856|-0.2484|0.3136
73999434|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.9929|TWO_SIDED|95.0|-0.0885|0.0893||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Precuneus||0.0893|-0.0885|0.9929
73999435|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.002||||0.949|TWO_SIDED|95.0|-0.0815|0.0767||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Precuneus\_base||0.0767|-0.0815|0.9490
73999436|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.065||||0.5668|TWO_SIDED|95.0|-0.3019|0.1722||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Superior Temporal||0.1722|-0.3019|0.5668
73999437|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.9958|TWO_SIDED|95.0|-0.1398|0.1391||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Premotor||0.1391|-0.1398|0.9958
73999438|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.057||||0.3379|TWO_SIDED|95.0|-0.0659|0.1795||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Putamen||0.1795|-0.0659|0.3379
73999439|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.085||||0.2186|TWO_SIDED|95.0|-0.2262|0.0565||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_S1||0.0565|-0.2262|0.2186
73999440|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.008||||0.8191|TWO_SIDED|95.0|-0.0843|0.0678||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Thalamus||0.0678|-0.0843|0.8191
74090659|NCT02040779|147735344|SUPERIORITY||LSM difference|-0.388||||0.0175|TWO_SIDED|95.0|-0.708|-0.068||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.068|-0.708|0.0175
73999441|NCT00760474|147547279|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.012||||0.7647|TWO_SIDED|95.0|-0.0698|0.093||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Precuneus||0.0930|-0.0698|0.7647
73999442|NCT02217501|147547310|SUPERIORITY|||||||0.6595||||||Alpha of 0.05|Cochran-Mantel-Haenszel|||||||0.6595
73999443|NCT05121246|147547311|EQUIVALENCE|CI 90% of least squares geometric means must be entirely contained within the range \[80%-125%\].||||||||||||||||PK parameters will be determined using a non-compartmental analysis method. Bioequivalence between MB05 and EU-Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be established by analysis of variance for the PK parameters AUC0-inf, and Cmax.|PK parameters for each participant will be listed and summarised by treatment using descriptive statistics.|||
73999444|NCT05121246|147547312|EQUIVALENCE|CI 90% of least squares geometric means must be entirely contained within the range \[80%-125%\].||||||||||||||||PK parameters will be determined using a non-compartmental analysis method. Bioequivalence between MB05 and EU-Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be established by analysis of variance for the PK parameters AUC0-inf, and Cmax.|PK parameters for each participant will be listed and summarised by treatment using descriptive statistics.|||
73999445|NCT00775463|147547321|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.2|TWO_SIDED|95.0|-1.0|0.0|||Cochran-Mantel-Haenszel|||A Cochran-Mantel Haenszel mean score test was used on the standardized reverse mid-ranks (overall reverse ranks divided by the number of ranks +1, or modified ridit scores; largely negative changes had ranks near 1 and largely positive changes had ranks near 0)of the residuals from an ordinary least squares regression with change in net ulcer burden at Week 20 as a linear function of Baseline PDEI or prostacyclin use (binary variable:Yes/No) and net ulcer burden at Baseline(continuous variable).||0.0|-1.0|0.20
73999446|NCT00775463|147547322|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-0.4||||0.31|TWO_SIDED|95.0|-1.4|0.4||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||0.40|-1.40|0.31
73999447|NCT00775463|147547323|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.12|TWO_SIDED|95.0|-21.3|2.7||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||2.7|-21.3|0.12
73999448|NCT00775463|147547324|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.04|TWO_SIDED|95.0|-18.0|0.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||0.0|-18.0|0.04
73999449|NCT00775463|147547325|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.47|TWO_SIDED|95.0|-4.0|2.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline in CHFS Score were tested using the Wilcoxon rank-sum test.||2.0|-4.0|0.47
73999450|NCT00775463|147547327|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.68|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||he difference between treatment groups for the change from Baseline and at Week 20 in the mRSS was tested using the Wilcoxon rank-sum test.||1.0|0.0|0.68
73999451|NCT00775463|147547328|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.54|TWO_SIDED|95.0|-3.0|2.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score||2.0|-3.0|0.54
73999452|NCT00775463|147547328|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Ef|-0.6||||0.18|TWO_SIDED|95.0|-1.6|0.3||P value for Pain VAS|Wilcoxon (Mann-Whitney)|||P value for Pain VAS||0.3|-1.6|0.18
74091718|NCT05472662|147737052|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|0.58||||0.483|TWO_SIDED|95.0|-1.1|2.25|||ANCOVA|||"Statistical analysis performed on the data at 5 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||2.25|-1.10|0.483
74091719|NCT05472662|147737052|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|0.23||||0.782|TWO_SIDED|95.0|-1.45|1.9|||ANCOVA|||"Statistical analysis performed on the data at 30 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||1.90|-1.45|0.782
73999453|NCT00775463|147547328|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.1|TWO_SIDED|95.0|-1.0|0.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score||0.0|-1.0|0.10
73999454|NCT01534689|147547358|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73999455|NCT01534689|147547359|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||results at 12 weeks compared to baseline||||<0.0001
73999456|NCT00768079|147547369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|||||||Fisher Exact|||Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.312
73999457|NCT00768079|147547369|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
73999458|NCT00768079|147547369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|||||||Fisher Exact|||Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.312
73999459|NCT00768079|147547369|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
73999460|NCT00768079|147547371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343|||||||Fisher Exact|||Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.343
73999461|NCT00768079|147547371|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
73999462|NCT00768079|147547371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343|||||||Fisher Exact|||Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.343
73999463|NCT00768079|147547371|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
73999464|NCT00768079|147547371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Fisher Exact|||Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.474
73999465|NCT00768079|147547371|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
73999466|NCT00768079|147547371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Fisher Exact|||Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.474
73999467|NCT00768079|147547371|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
73999468|NCT03699085|147547438|EQUIVALENCE|A p value of \< 0.05 suggests the groups are different.||||||0.38||||||A p value of \< 0.05 suggests the groups are different.|Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test is used, which ranks the values in each group, sums the ranks and determines the probability that they are the same. The probability p-value is reported.||||0.38
73999469|NCT03699085|147547439|SUPERIORITY|Adjusted mixed effects regression models were used to determine whether patients in the intervention and control group manifested different patterns of change in days of heroin use in the past 30 days in terms of incidence-rate ratio. We applied a negative binomial distribution to help account for overdispersion of outcome data.|Incidence rate ratio|1.29||||0.68|TWO_SIDED|95.0|0.38|4.37||A p value of \< 0.05 suggests the groups are different.|Regression, Cox||A number greater than 1.0 indicates a higher incidence rate of heroin use in past 30 days for intervention group compared to control group|Comparison of control and intervention populations based on substance use measured utilizing a time-line follow back (TLFB) calendar administered by the research assistant to for past 30-day heroin use. This is a covariate-adjusted mixed effects regression model at TLFB timepoint of 6 months. A number greater than 1.0 indicates a higher incidence of heroin use in the past 30 days at the 6 month timepoint for intervention group compared to control group.||4.37|0.38|0.68
73999470|NCT05383508|147547441|OTHER||Geometric LS Mean Ratio (%)|17.05|||||TWO_SIDED|95.0|10.69|27.19||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the Cmax ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||27.19|10.69|
73999471|NCT05383508|147547441|OTHER||Geometric LS Mean Ratio (%)|19.47|||||TWO_SIDED|95.0|11.89|31.87||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the Cmax ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||31.87|11.89|
73999472|NCT05383508|147547442|OTHER||Median Difference (Net)|3.0|||||TWO_SIDED|95.0|0.0|11.0||95% confidence intervals are provided for this analysis.|Wilcoxon signed rank test||Hodges-Lehmann estimator of location shift and Moses 95% CI|The objective of this study was to determine the Tmax difference of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||11.00|0.00|
73999473|NCT05383508|147547442|OTHER||Mean Difference (Net)|2.0|||||TWO_SIDED|95.0|0.0|4.0||95% confidence intervals are provided for this analysis.|Wilcoxon signed rank test||Hodges-Lehmann estimator of location shift and Moses 95% CI|The objective of this study was to determine the Tmax difference of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||4.00|0.00|
73999474|NCT05383508|147547443|OTHER||Geometric LS Mean Ratio (%)|28.29|||||TWO_SIDED|95.0|16.0|50.04||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the AUC0-infinity ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||50.04|16.00|
73877104|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-27.5||||0.345|TWO_SIDED|95.0|-61.3|6.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||6.3|-61.3|0.345
73999475|NCT05383508|147547443|OTHER||Geometric LS Mean Ratio (%)|26.16|||||TWO_SIDED|95.0|12.74|53.69||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the AUC0-infinity ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||53.69|12.74|
73999476|NCT05383508|147547444|OTHER||Geometric LS Mean Ratio (%)|10.84|||||TWO_SIDED|95.0|5.57|21.1||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the maximum ratio of background-corrected concentration over time of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||21.10|5.57|
73999477|NCT05383508|147547444|OTHER||Geometric LS Mean Ratio (%)|16.83|||||TWO_SIDED|95.0|9.93|28.53||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the maximum ratio of background-corrected concentration over time of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||28.53|9.93|
73999478|NCT01871805|147547453|SUPERIORITY|||||||0.0056||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0056
73999479|NCT01871805|147547454|SUPERIORITY|||||||0.0251||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0251
73999480|NCT01871805|147547454|SUPERIORITY|||||||0.0203||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0203
73999481|NCT01871805|147547456|SUPERIORITY|||||||0.001||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0010
73999482|NCT03097484|147547479|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
73999483|NCT03097484|147547480|SUPERIORITY|||||||0.05||||||0.05 is the calculated p-value (not the threshold for statistical significance)|t-test, 2 sided|||||||0.05
73999484|NCT00468104|147547502|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||A univariate analysis was done to identify possible predictors of successful resolution of symptoms. The chi-square analysis was used to compare the percent successful.||||<0.001
73999485|NCT00371683|147547568|NON_INFERIORITY_OR_EQUIVALENCE|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% confidence interval (CI) for the Relative Risk should be \< 1.25, and the upper bound of the 95% CI for the risk difference should be \< 5.6%.|Risk Ratio (RR)|1.02||||0.0635|TWO_SIDED|95.0|0.78|1.32||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided|||||1.32|0.78|0.0635
74036632|NCT02370498|147626592|OTHER||Hazard Ratio (HR)|1.11||||0.80696|TWO_SIDED|95.0|0.89|1.38||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.38|0.89|0.80696
73999486|NCT00371683|147547568|NON_INFERIORITY_OR_EQUIVALENCE|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% CI for the relative risk should be \< 1.25, and the upper bound of the 95% CI for the risk difference should be \< 5.6%.|Risk Difference (RD)|0.11|||<|0.0001|TWO_SIDED|95.0|-2.22|2.44||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided|||||2.44|-2.22|<0.0001
73999487|NCT00371683|147547569|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.7|2.23|||||If the upper bound of the two-sided 95% CI for the Relative Risk was \< 1 then superiority for the key secondary efficacy endpoint was demonstrated.|||2.23|0.70|
73999488|NCT00371683|147547569|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.36|||||TWO_SIDED|95.0|-0.68|1.4||||||||1.40|-0.68|
73999489|NCT00371683|147547569|SUPERIORITY_OR_OTHER|||||||0.7779|TWO_SIDED||||||t-test, 1 sided|||||||0.7779
73999490|NCT00371683|147547570|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.8|1.35||||||||1.35|0.80|
73999491|NCT00371683|147547570|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-2.04|2.59||||||||2.59|-2.04|
73999492|NCT00371683|147547570|SUPERIORITY_OR_OTHER|||||||0.7754|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.7754
73999493|NCT00371683|147547571|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.77|2.6||||||||2.60|0.77|
73999494|NCT00371683|147547571|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.53|||||TWO_SIDED|95.0|-0.47|1.52||||||||1.52|-0.47|
73999495|NCT00371683|147547571|SUPERIORITY_OR_OTHER|||||||0.2626|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.2626
73999496|NCT00371683|147547572|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.63|1.87||||||||1.87|0.63|
73999497|NCT00371683|147547572|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11|||||TWO_SIDED|95.0|-0.99|1.21||||||||1.21|-0.99|
73999498|NCT00371683|147547572|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.7700
73999499|NCT00371683|147547573|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.68|2.11||||||||2.11|0.68|
74036633|NCT02370498|147626593|OTHER||Hazard Ratio (HR)|1.34||||0.99932|TWO_SIDED|95.0|1.12|1.6||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.60|1.12|0.99932
74036634|NCT02370498|147626594|OTHER||Hazard Ratio (HR)|1.45||||0.99661|TWO_SIDED|95.0|1.11|1.89||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.89|1.11|0.99661
74036635|NCT02370498|147626595|OTHER||Hazard Ratio (HR)|1.77||||1|TWO_SIDED|95.0|1.42|2.2||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||2.20|1.42|1.00000
74036636|NCT02370498|147626596|OTHER||Hazard Ratio (HR)|0.97||||0.3928|TWO_SIDED|95.0|0.77|1.23||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.23|0.77|0.39280
74036637|NCT02370498|147626597|OTHER||Hazard Ratio (HR)|1.21||||0.97033|TWO_SIDED|95.0|1.0|1.47||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.47|1.00|0.97033
74036638|NCT02370498|147626598|OTHER||Difference in Percentage|2.0||||0.28967|TWO_SIDED|95.0|-5.0|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen's (MN) method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||9.1|-5.0|0.28967
73999500|NCT00371683|147547573|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-0.78|1.33||||||||1.33|-0.78|
73999501|NCT00371683|147547573|SUPERIORITY_OR_OTHER|||||||0.5443|TWO_SIDED||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates||||||0.5443
74036639|NCT02370498|147626599|OTHER||Difference in Percentage|-1.3||||0.6901|TWO_SIDED|95.0|-6.5|4.0||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||4.0|-6.5|0.69010
74036640|NCT02370498|147626600|OTHER||Difference in Percentage|1.6||||0.3322|TWO_SIDED|95.0|-5.8|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months), weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||9.1|-5.8|0.33220
74039819|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0845|TWO_SIDED|95.0|-0.42|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.42|0.0845
73999502|NCT00371683|147547574|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.2|4.93||||||||4.93|0.20|
73999503|NCT00371683|147547574|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||||0.30|-0.30|
73999504|NCT00371683|147547574|SUPERIORITY_OR_OTHER|||||||0.9975|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.9975
73999505|NCT00371683|147547575|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.05|0.3||||||||0.30|-0.05|
73999506|NCT00371683|147547575|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.1578
73999507|NCT00371683|147547576|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.65|2.4||||||||2.40|0.65|
73999508|NCT00371683|147547576|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.47|0.98||||||||0.98|-0.47|
73999509|NCT00371683|147547577|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.46|||||TWO_SIDED|95.0|0.72|2.95||||||||2.95|0.72|
73877105|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||57.1|-37.1|1.000
73877106|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|10.0||||0.588|TWO_SIDED|95.0|-26.1|46.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.1|-26.1|0.588
73877107|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-15.0||||0.657|TWO_SIDED|95.0|-53.9|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.9|-53.9|0.657
73877108|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|20.0||||0.635|TWO_SIDED|95.0|-25.4|65.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||65.4|-25.4|0.635
73877109|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|10.5||||0.573|TWO_SIDED|95.0|-25.7|46.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||46.7|-25.7|0.573
73877110|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-34.2||||0.176|TWO_SIDED|95.0|-68.3|-0.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||-0.1|-68.3|0.176
73877111|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
73877112|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
73877113|NCT02365649|147294855|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
73877114|NCT02365649|147294856|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||5.0|-55.0|1.000
73877115|NCT02365649|147294856|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-32.5|57.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||57.5|-32.5|1.000
73877116|NCT02365649|147294856|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||5.0|-55.0|0.487
73877117|NCT02365649|147294856|SUPERIORITY||Risk Difference (RD)|11.1||||0.375|TWO_SIDED|95.0|-9.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ|Non-respoonders||31.6|-9.4|0.375
73999510|NCT00371683|147547577|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.38|||||TWO_SIDED|95.0|-0.3|1.06||||||||1.06|-0.30|
73999511|NCT00371683|147547577|SUPERIORITY_OR_OTHER|||||||0.2873|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.2873
73877118|NCT02365649|147294856|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||3.9|-30.5|1.000
73999512|NCT00371683|147547578|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.74|1.2||||||||1.20|0.74|
73999513|NCT00371683|147547578|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.83|||||TWO_SIDED|95.0|-3.3|1.63||||||||1.63|-3.30|
73999514|NCT00371683|147547578|SUPERIORITY_OR_OTHER|||||||0.6145|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.6145
73877119|NCT02365649|147294856|SUPERIORITY||Risk Difference (RD)|8.1||||0.651|TWO_SIDED|95.0|-19.4|35.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.6|-19.4|0.651
73877120|NCT02365649|147294856|SUPERIORITY||Risk Difference (RD)|-0.8||||1|TWO_SIDED|95.0|-29.5|27.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||27.8|-29.5|1.000
73877121|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||77.5|-77.5|1.000
73999515|NCT00371683|147547581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.55|0.05||||||Adjusted difference of event rates of MI/Stroke. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.55|
73999516|NCT00371683|147547581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.19|||||TWO_SIDED|95.0|-0.46|0.09||||||Adjusted difference of event rates of MI. Type of surgery was taken into consideration as a stratification factor.||0.09|-0.46|
73999517|NCT00371683|147547581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13|||||TWO_SIDED|95.0|-0.3|0.05||||||Adjusted difference of event rates of Stroke. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.30|
73999518|NCT00371683|147547581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13|||||TWO_SIDED|95.0|-0.3|0.05||||||Adjusted difference of event rates of thrombocytopenia. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.30|
73999519|NCT00371683|147547582|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.81|||||TWO_SIDED|95.0|-1.49|-0.14||||||Adjusted difference of event rates of Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||-0.14|-1.49|
73999520|NCT00371683|147547582|SUPERIORITY_OR_OTHER|||||||0.0533|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Major Bleeding Endpoint||||0.0533
73999521|NCT00371683|147547582|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.77|||||TWO_SIDED|95.0|-1.87|0.33||||||Adjusted difference of event rates of Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||0.33|-1.87|
73877122|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||49.0|-49.0|1.000
73877123|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||-15.4|-84.6|0.105
73877124|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-64.5|89.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||89.5|-64.5|1.000
73999522|NCT00371683|147547582|SUPERIORITY_OR_OTHER|||||||0.1709|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Clinically relevant Non-Major Bleeding endpoint||||0.1709
73999523|NCT00371683|147547582|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.46|||||TWO_SIDED|95.0|-2.75|-0.17||||||Adjusted difference of event rates of Major or Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||-0.17|-2.75|
73999524|NCT00371683|147547582|SUPERIORITY_OR_OTHER|||||||0.0338|TWO_SIDED||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates||Major or Clinically Relevant Non-Major Bleeding endpoint.||||0.0338
74036641|NCT02370498|147626601|OTHER||Difference in Percentage|-3.0||||0.85922|TWO_SIDED|95.0|-8.5|2.6||Stratification factors included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen's method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm is provided.||2.6|-8.5|0.85922
73999525|NCT00371683|147547582|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.52|||||TWO_SIDED|95.0|-3.18|0.13||||||Adjusted difference of event rates of Any Bleeding. Type of surgery was taken into consideration as a stratification factor.||0.13|-3.18|
73999526|NCT00371683|147547582|SUPERIORITY_OR_OTHER|||||||0.0816|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Any Bleeding Endpoint.||||0.0816
73999527|NCT01131182|147547614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0||||Assessed for relative risk using prior therapy (monotherapy or combination therapy) as a stratification factor.|Cochran-Mantel-Haenszel|||||||0.0005
73999528|NCT00662818|147547616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.329|TWO_SIDED|95.0|0.62|4.25|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||4.25|0.62|0.329
73999529|NCT00662818|147547617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.42|TWO_SIDED|95.0|0.59|3.5|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||3.50|0.59|0.420
73999530|NCT00662818|147547621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.648|TWO_SIDED|95.0|0.52|2.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||2.85|0.52|0.648
73999531|NCT00662818|147547622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.647|TWO_SIDED|95.0|0.31|2.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||2.07|0.31|0.647
73999532|NCT00662818|147547623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.201|TWO_SIDED|95.0|0.73|4.6|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||4.60|0.73|0.201
73999533|NCT00662818|147547624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.579|TWO_SIDED|95.0|0.47|3.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||3.85|0.47|0.579
73999534|NCT02327351|147547656|SUPERIORITY||survival distribution function|86.0||||0.95|TWO_SIDED|95.0|79.0|94.0|||Gray test|||||94|79|0.95
73999535|NCT02327351|147547662|SUPERIORITY|||||||0.35|||||||Log Rank|||||||0.35
73999536|NCT03988920|147547663|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7439|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.7439
73999537|NCT02656329|147547675|NON_INFERIORITY|Non-inferiority of AdreView™ group over SoC group was demonstrated if upper bound of the 95% confidence interval (CI) for the hazard ratio (HR) (AdreView™ group / SoC) was equal to 1.20.|Hazard Ratio (HR)|1.047||||0.8459|TWO_SIDED|95.0|0.295|3.719||Threshold for significance at 0.025 level.|Log Rank||AdreView™ vs. Standard of Care|Analysis was performed using the Cox proportional hazards model stratified by country, with method of treatment guidance (SoC vs AdreView™ group) as the only covariate.||3.719|0.295|0.8459
73999538|NCT01139580|147547684|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73999539|NCT01139580|147547687|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
73877125|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||60.7|-35.7|1.000
73999540|NCT00911768|147547690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.416|<|0.05||95.0|-0.647|1.008|||t-test, 2 sided|||||1.008|-0.647|<0.05
73999541|NCT00911768|147547691|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was conducted. We just compared the difference of stimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.116|<|0.05||95.0|-0.576|-0.115|||t-test, 2 sided|||||-0.115|-0.576|<0.05
73999542|NCT00911768|147547692|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was conducted. We just compared the difference of unstimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.035|<|0.05||95.0|-0.155|-0.017|||t-test, 2 sided|||||-0.017|-0.155|<0.05
73999543|NCT00467350|147547705|SUPERIORITY_OR_OTHER_LEGACY|"Similar to previous studies, the main outcome measure was the change in the child's main symptom. Changes were determined by the question Has your child's main symptom improved, stayed the same or gotten worse? The main symptom was defined as the chief complaint identified during the triage process. For analysis, responses were dichotomized into 2 groups: improved/better versus worse/same."|||||||||||||||||A χ2 test was used to examine the difference in probabilities of experiencing an outcome between treatment arms and differences were expressed by Mantel-Haenszel common OR estimate with 95% confidence interval (CI).|||
73999544|NCT02842151|147547707|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.346|||TWO_SIDED|90.0|-0.03|0.13||||||To demonstrate equivalency at Site 1, A-constant with manifest refraction was compared to A-constant with autorefraction.||0.13|-0.03|
73999545|NCT02842151|147547707|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.07|STANDARD_DEVIATION|0.595|||TWO_SIDED|90.0|-0.21|0.07||||||To demonstrate equivalency at Site 2, A-constant with manifest refraction was compared to A-constant with autorefraction.||0.07|-0.21|
73999546|NCT02842151|147547707|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.13|STANDARD_DEVIATION|0.34|||TWO_SIDED|90.0|-0.22|-0.04||||||To demonstrate equivalency at Site 3, A-constant with manifest refraction was compared to A-constant with autorefraction.||-0.04|-0.22|
73999547|NCT02559895|147547709|SUPERIORITY||Mean Difference (Final Values)|-1.11|STANDARD_DEVIATION|3.4||0.0001|TWO_SIDED|95.0|-1.68|-0.54|||ANCOVA|||||-0.54|-1.68|0.0001
73999548|NCT02559895|147547709|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_DEVIATION|3.4||0.0182|TWO_SIDED|95.0|-1.25|-0.12|||ANCOVA|||||-0.12|-1.25|0.0182
73999549|NCT02559895|147547709|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_DEVIATION|3.4||0.0046|TWO_SIDED|95.0|-1.39|-0.25|||ANCOVA|||||-0.25|-1.39|0.0046
73999550|NCT02559895|147547710|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.0007|TWO_SIDED|95.0|5.8|21.2|||Cochran-Mantel-Haenszel|||||21.2|5.8|0.0007
73999551|NCT02559895|147547710|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.1126|TWO_SIDED|95.0|-1.4|13.3|||Cochran-Mantel-Haenszel|||||13.3|-1.4|0.1126
73999552|NCT02559895|147547710|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.0272|TWO_SIDED|95.0|1.0|15.9|||Cochran-Mantel-Haenszel|||||15.9|1.0|0.0272
73999553|NCT02559895|147547711|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.0066|TWO_SIDED|95.0|3.2|19.3|||Cochran-Mantel-Haenszel|||||19.3|3.2|0.0066
73999554|NCT02559895|147547711|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.0112|TWO_SIDED|95.0|2.4|18.6|||Cochran-Mantel-Haenszel|||||18.6|2.4|0.0112
73999555|NCT02559895|147547711|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.017|TWO_SIDED|95.0|1.8|17.8|||Cochran-Mantel-Haenszel|||||17.8|1.8|0.0170
73999556|NCT02559895|147547712|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.0001|TWO_SIDED|95.0|9.8|28.0|||Cochran-Mantel-Haenszel|||||28.0|9.8|0.0001
73999557|NCT02559895|147547712|SUPERIORITY||Mean Difference (Final Values)|12.4||||0.0085|TWO_SIDED|95.0|3.2|21.5|||Cochran-Mantel-Haenszel|||||21.5|3.2|0.0085
73999558|NCT02559895|147547712|SUPERIORITY||Mean Difference (Final Values)|12.8||||0.0064|TWO_SIDED|95.0|3.7|22.0|||Cochran-Mantel-Haenszel|||||22.0|3.7|0.0064
73999559|NCT02559895|147547713|SUPERIORITY|||||||0.0159|||||||Cochran-Mantel-Haenszel|||||||0.0159
73999560|NCT02559895|147547713|SUPERIORITY|||||||0.0312|||||||Cochran-Mantel-Haenszel|||||||0.0312
73999561|NCT02559895|147547713|SUPERIORITY|||||||0.1539|||||||Cochran-Mantel-Haenszel|||||||0.1539
73999562|NCT03748992|147547746|OTHER|Since no hypothesis testing was planned, no power analysis was required||||||||||||Non Applicable||Non Applicable||This was a single arm trial. there is no comparator group.|The overall response rates were calculated, and exact binomial confidence intervals was constructed.|||
73999563|NCT03748992|147547748|OTHER|Since no hypothesis testing was planned, no power analysis was required||||||||||||||||This was a single arm trial. there is no comparator group.|The overall response rates were calculated, and exact binomial confidence intervals was constructed.|||
73999564|NCT00604825|147547769|SUPERIORITY||Adjusted Mean Difference|0.75||||0.215|TWO_SIDED|95.0|-0.44|1.93||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg||1.93|-0.44|0.215
73999565|NCT00604825|147547769|SUPERIORITY||Adjusted Mean Difference|1.21||||0.041|TWO_SIDED|95.0|0.05|2.37||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg||2.37|0.05|0.041
73999566|NCT00604825|147547769|SUPERIORITY||Adjusted Mean Difference|-2.06|||<|0.001|TWO_SIDED|95.0|-3.2|-0.92||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg||-0.92|-3.20|<0.001
73999567|NCT00604825|147547770|SUPERIORITY||Adjusted Mean Difference|0.15||||0.202|TWO_SIDED|95.0|-0.08|0.38||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg||0.38|-0.08|0.202
73999568|NCT00604825|147547770|SUPERIORITY||Adjusted Mean Difference|0.31||||0.008|TWO_SIDED|95.0|0.08|0.54||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg||0.54|0.08|0.008
73999569|NCT00604825|147547770|SUPERIORITY||Adjusted Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.75|-0.3||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg||-0.30|-0.75|<0.001
73999570|NCT03541174|147547863|SUPERIORITY||LS Mean difference to placebo|-3.79||||0.0042|TWO_SIDED|97.5|-6.76|-0.82||Mixed effects model for Repeated Measures: Change from baseline in SiSBP = baseline SiSBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-0.82|-6.76|0.0042
73999571|NCT03541174|147547863|SUPERIORITY||LS Mean difference to placebo|-3.73||||0.0046|TWO_SIDED|97.5|-6.67|-0.78||Mixed effects model for Repeated Measures: Change from baseline in SiSBP = baseline SiSBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-0.78|-6.67|0.0046
73999572|NCT03541174|147547864|SUPERIORITY||LS mean difference to placebo.|-5.82|||<|0.0001|TWO_SIDED|95.0|-7.94|-3.71||Mixed effects model for Repeated Measures: Change from DB-WD baseline in SiSBP = DB-WD baseline SiSBP + stratum (randomized treatment in DB part) + treatment + visit + treatment x visit + DB-WD baseline x visit.|Mixed Models Analysis|||||-3.71|-7.94|<0.0001
73999573|NCT03541174|147547865|OTHER||LS Mean difference to placebo|-3.94|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.31||Mixed effects model for Repeated Measures: Change from baseline in SiDBP = baseline SiDBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-2.31|-5.57|<0.0001
73999574|NCT03541174|147547865|OTHER||LS Mean difference to placebo|-4.47|||<|0.0001|TWO_SIDED|95.0|-6.09|-2.85||Mixed effects model for Repeated Measures: Change from baseline in SiDBP = baseline SiDBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-2.85|-6.09|<0.0001
73999575|NCT03541174|147547866|OTHER||LS Mean difference to placebo|-4.18|||<|0.0001|TWO_SIDED|95.0|-6.25|-2.12|||ANCOVA|||24-hour mean systolic (SBP)||-2.12|-6.25|<0.0001
73999576|NCT03541174|147547866|OTHER||LS Mean difference to placebo|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.94|-3.85|||ANCOVA|||24-hour mean systolic (SBP)||-3.85|-7.94|<0.0001
73999577|NCT03541174|147547866|OTHER||LS Mean difference to placebo|-4.32|||<|0.0001|TWO_SIDED|95.0|-5.66|-2.98|||ANCOVA|||24-hour mean diastolic (DBP)||-2.98|-5.66|<0.0001
73999578|NCT03541174|147547866|OTHER||LS Mean|-5.81|||<|0.0001|TWO_SIDED|95.0|-7.14|-4.49|||ANCOVA|||24-hour mean diastolic (DBP)||-4.49|-7.14|<0.0001
73999579|NCT03541174|147547867|OTHER||LS Mean difference to placebo|-5.19|||<|0.0001|TWO_SIDED|95.0|-6.62|-3.76||Mixed effects model for Repeated Measures: Change from DB-WD baseline in SiDBP = Double-blind withdrawal baseline SiDBP + stratum (randomized treatment in DB part) + treatment + visit + treatment x visit + Double-blind withdrawal baseline x visit.|Mixed Models Analysis|||||-3.76|-6.62|<0.0001
73999580|NCT03541174|147547868|OTHER||LS Mean difference to placebo|-6.53|||<|0.0001|TWO_SIDED|95.0|-8.5|-4.56|||ANCOVA|||24-hour mean systolic (SBP)||-4.56|-8.50|<0.0001
73999581|NCT03541174|147547868|OTHER||LSM Mean difference to placebo|-6.75|||<|0.0001|TWO_SIDED|95.0|-7.98|-5.52|||ANCOVA|||24-hour mean diastolic (DBP)||-5.52|-7.98|<0.0001
73999582|NCT02217332|147547871|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-test comparing baseline to month 6 on log scale within the dexpramipexole treatment group.||Null hypothesis is the ratio of Month 6 to Baseline within the dexpramipexole group equals '1'.||||< 0.001
73999583|NCT02217332|147547872|SUPERIORITY|||||||0.885||||||Month 6/LOCF was used for the analysis of change from Baseline to Month 6 within the dexpramipexole group.|t-test, 2 sided|||||||0.885
73999584|NCT02217332|147547876|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-test comparing baseline to month 3 on log scale within the dexpramipexole treatment group.||Null hypothesis is the ratio of Month 3 to Baseline within the dexpramipexole group equals '1'.||||<.001
73999585|NCT02217332|147547877|SUPERIORITY|||||||1||||||Month 3/LOCF was used for the analysis of change from Baseline to Month 3 within the dexpramipexole group.|t-test, 2 sided|Paired t-test comparing baseline to month 3 within the dexpramipexole treatment group||||||1.0
73999586|NCT02217332|147547878|SUPERIORITY||log scale|||||0.001|||||||Wilcoxon Signed Rank Test (paired)|||Null hypothesis is the ratio of Month 6 to Baseline within the dexpramipexole group equals '1'; 68% confidence interval is equal to plus/minus 1 standard error||||0.001
73999587|NCT00852540|147547912|SUPERIORITY_OR_OTHER||percentage of participants|56.9|||||TWO_SIDED|95.0|45.5|68.4|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.|||68.4|45.5|
73999588|NCT00852540|147547912|SUPERIORITY_OR_OTHER||Percentage of participants|84.2|||||TWO_SIDED|95.0|72.6|95.8|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.|||95.8|72.6|
73999589|NCT00618618|147547926|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.005|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||-0.2|-1.0|0.005
73999590|NCT00618618|147547926|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.001|TWO_SIDED|95.0|-1.4|-0.4|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||-0.4|-1.4|0.001
73999591|NCT00618618|147547926|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.069|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||0.0|-0.8|0.069
73999592|NCT00618618|147547927|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.005|TWO_SIDED|95.0|0.6|3.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||3.0|0.6|0.005
73999593|NCT00618618|147547927|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5||||0.001|TWO_SIDED|95.0|1.0|4.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||4.0|1.0|0.001
73999594|NCT00618618|147547927|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.122|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||2.2|-0.3|0.122
73999595|NCT00618618|147547928|SUPERIORITY_OR_OTHER||Difference from Placebo|38.3||||0.008|TWO_SIDED|95.0|11.0|65.7|||Fisher Exact|||||65.7|11.0|0.008
73999596|NCT00618618|147547928|SUPERIORITY_OR_OTHER||Difference from Placebo|32.9||||0.172|TWO_SIDED|95.0|1.0|64.8|||Fisher Exact|||||64.8|1.0|0.172
73999597|NCT00618618|147547928|SUPERIORITY_OR_OTHER||Difference from Placebo|22.9||||0.252|TWO_SIDED|95.0|-8.4|54.2|||Fisher Exact|||||54.2|-8.4|0.252
73999598|NCT00618618|147547929|SUPERIORITY_OR_OTHER||Difference from Placebo|46.1||||0.011|TWO_SIDED|95.0|16.3|75.9|||Fisher Exact|||||75.9|16.3|0.011
73999599|NCT00618618|147547929|SUPERIORITY_OR_OTHER||Difference from Placebo|54.3||||0.013|TWO_SIDED|95.0|23.0|85.5|||Fisher Exact|||||85.5|23.0|0.013
73999600|NCT00618618|147547929|SUPERIORITY_OR_OTHER||Difference from Placebo|24.3||||0.296|TWO_SIDED|95.0|-8.7|57.3|||Fisher Exact|||||57.3|-8.7|0.296
73999601|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.46|TWO_SIDED|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.5|0.460
73999602|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.906|TWO_SIDED|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.5|0.906
73999603|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.404|TWO_SIDED|95.0|-0.6|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.6|0.404
73999604|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.791|TWO_SIDED|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.3|-0.5|0.791
73999605|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.41|TWO_SIDED|95.0|-0.3|0.6|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.6|-0.3|0.410
73999606|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.733|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.5|-0.3|0.733
73999607|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.542|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.5|-0.3|0.542
73999608|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.882|TWO_SIDED|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.5|-0.4|0.882
73999609|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.934|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.4|-0.4|0.934
73999610|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.838|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.4|0.838
73999611|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.777|TWO_SIDED|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.5|0.777
73999612|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.795|TWO_SIDED|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.5|-0.4|0.795
73999613|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS mean Difference|0.0||||0.852|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.4|-0.4|0.852
73999614|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.444|TWO_SIDED|95.0|-0.6|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.3|-0.6|0.444
73877126|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||31.0|-66.0|1.000
73877127|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|62.5||||0.444|TWO_SIDED|95.0|29.0|96.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||96.0|29.0|0.444
73999615|NCT00618618|147547930|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.724|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.5|-0.3|0.724
73999616|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.934|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.4|0.934
73999617|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.286|TWO_SIDED|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.7|0.286
73999618|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.19|TWO_SIDED|95.0|-0.1|0.7|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.7|-0.1|0.190
73999619|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.402|TWO_SIDED|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.2|-0.5|0.402
73999620|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.29|TWO_SIDED|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.2|-0.7|0.290
73999621|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.863|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.4|-0.4|0.863
73999622|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.128|TWO_SIDED|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.1|-0.7|0.128
74036642|NCT02370498|147626607|OTHER||Difference in Percentage|-3.2|||||TWO_SIDED|95.0|-6.9|0.2||||||Between-treatment differences (Pembrolizumab vs. Paclitaxel) in the percentage of participants with events and accompanying 95% confidence intervals were based on the Miettinen and Nurminen method. Negative values correspond to a greater percentage of events for Paclitaxel.||0.2|-6.9|
74036643|NCT01089582|147626612|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED||||||Regression, Logistic|||The effect of possible prognostic factors response on response rate: primary diagnosis severity. Participants were classified as responders if they were very much improved or much improved from baseline.||||0.0023
73999623|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.018|TWO_SIDED|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||-0.1|-0.9|0.018
73999624|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.489|TWO_SIDED|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.3|-0.5|0.489
73999625|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.007|TWO_SIDED|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||-0.1|-0.9|0.007
73999626|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.3|-0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||-0.4|-1.3|<0.001
73999627|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.122|TWO_SIDED|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.1|-0.7|0.122
73999628|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.005|TWO_SIDED|95.0|-0.9|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.2|-0.9|0.005
73999629|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.3|-1.2|<0.001
73999630|NCT00618618|147547931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.007|TWO_SIDED|95.0|-1.0|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.2|-1.0|0.007
73999631|NCT00618618|147547933|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9||||0.573|TWO_SIDED|95.0|-8.6|4.8|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||4.8|-8.6|0.573
74036644|NCT01089582|147626613|SUPERIORITY_OR_OTHER|||||||0.0382|TWO_SIDED||||||Regression, Logistic|||The effect of possible prognostic factors on response: significant medical history. Participants were classified as responders if they were much improved or improved from baseline.||||0.0382
74036645|NCT01089582|147626614|SUPERIORITY_OR_OTHER|||||||0.1805|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.||||0.1805
74036646|NCT01089582|147626614|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by participant.||||<0.0001
73877128|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|25.0||||0.619|TWO_SIDED|95.0|-22.4|72.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||72.4|-22.4|0.619
73999632|NCT00618618|147547933|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.653|TWO_SIDED|95.0|-6.3|9.9|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||9.9|-6.3|0.653
73999633|NCT00618618|147547933|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.688|TWO_SIDED|95.0|-5.4|8.1|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||8.1|-5.4|0.688
73999634|NCT02929329|147547935|SUPERIORITY|"The overall type I error was 0.05 for 2-sided testing across primary and secondary outcomes.~Control for multiple comparisons was achieved using the following testing algorithm: if the primary outcome met the P-value threshold of 0.05, the alpha error would be divided unequally between cardiovascular death (96% of the overall alpha error, or 0.048) and change from baseline to week 24 in the Kansas City Cardiomyopathy Questionnaire total symptom score (4% of the overall alpha error, or 0.002)."|Hazard Ratio (HR)|0.92||||0.0252|TWO_SIDED|95.0|0.86|0.99|||Regression, Cox|Stratified by randomization setting and region, including terms for baseline estimated glomerular filtration rate (eGFR) and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|||0.99|0.86|0.0252
73999635|NCT02929329|147547935|SUPERIORITY|||||||0.0211|||||||Stratified log-rank test|Log-rank test stratified by randomization setting and region.||||||0.0211
73999636|NCT02929329|147547935|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.86|0.99|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint were considered as the competing risk.||0.99|0.86|
73999637|NCT02929329|147547936|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8555|TWO_SIDED|95.0|0.92|1.11||If significance for the primary outcome was determined, cardiovascular death was tested against an alpha of 0.048.|Regression, Cox|Stratified by randomization setting and region, including terms for baseline eGFR and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|||1.11|0.92|0.8555
73999638|NCT02929329|147547936|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.92|1.11|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint were considered as the competing risk.||1.11|0.92|
73999639|NCT02929329|147547937|OTHER||Least Squares (LS) Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-1.4|0.48|||||Treatment difference = Omecamtiv mecarbil - Placebo|||0.48|-1.40|
73999640|NCT02929329|147547937|OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|0.54|4.46|||||Treatment difference = Omecamtiv mecarbil - Placebo|||4.46|0.54|
73999641|NCT02929329|147547937|SUPERIORITY|If significance for the primary outcome was determined, change from baseline in the KCCQ total symptom score was tested against an alpha of 0.002.||||||0.0278|||||||Omnibus F-test|||||||0.0278
73999642|NCT02929329|147547937|OTHER||Pooled treatment difference|0.75|||||TWO_SIDED|95.0|-2.55|4.51|||||Overall pooled estimate of treatment difference (Omecamtiv mecarbil - Placebo) using random effects meta-analysis approach.|||4.51|-2.55|
73999643|NCT02929329|147547937|SUPERIORITY||LS Mean Difference|-0.71|||||TWO_SIDED|95.0|-1.62|0.2|||||Treatment difference = Omecamtiv mecarbil - Placebo|As a sensitivity for missing data due to death, joint longitudinal and survival models were fit using KCCQ TSS observed values with random subject slopes and intercepts for the longitudinal models with terms for baseline eGFR, region, and treatment by slope. The survival models were fit for all-cause death with baseline eGFR and treatment in the proportional hazard part of the models, KCCQ TSS modeled values as the shared parameterization, stratified by region with Weibull baseline functions.||0.20|-1.62|
73999644|NCT02929329|147547937|SUPERIORITY||LS mean difference|2.31|||||TWO_SIDED|95.0|0.8|3.82|||||Treatment difference = Omecamtiv mecarbil - Placebo|As a sensitivity for missing data due to death, joint longitudinal and survival models were fit using KCCQ TSS observed values with random subject slopes and intercepts for the longitudinal models with terms for baseline eGFR, region, and treatment by slope. The survival models were fit for all-cause death with baseline eGFR and treatment in the proportional hazard part of the models, KCCQ TSS modeled values as the shared parameterization, stratified by region with Weibull baseline functions.||3.82|0.80|
73999645|NCT02929329|147547938|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.1902|TWO_SIDED|95.0|0.87|1.03||If statistical significance was achieved for both the time to CV death and change from baseline in the KCCQ TSS, time to first heart failure hospitalization was to be tested at the full alpha.|Regression, Cox|Stratified by randomization setting and region, including terms for baseline eGFR and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|||1.03|0.87|0.1902
73999646|NCT02929329|147547938|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.04|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint are considered as the competing risk.||1.04|0.88|
74036647|NCT01089582|147626614|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.||||<0.0001
74036648|NCT01089582|147626615|SUPERIORITY_OR_OTHER|||||||0.0137|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.||||0.0137
74036649|NCT01089582|147626615|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by caregiver.||||<0.0001
73877129|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-37.5||||0.231|TWO_SIDED|95.0|-71.0|-4.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-4.0|-71.0|0.231
73877130|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-37.5||||1|TWO_SIDED|95.0|-71.0|-4.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||-4.0|-71.0|1.000
73999647|NCT02929329|147547939|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9633|TWO_SIDED|95.0|0.92|1.09||If time to first heart failure hospitalization was statistically significant, time to all-cause death was to be tested with the same alpha as time to first heart failure hospitalization.|Regression, Cox||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|||1.09|0.92|0.9633
73999648|NCT01183234|147547940|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.953|||||TWO_SIDED|90.0|0.915|0.993|||Mixed Models Analysis|||||0.993|0.915|
73999649|NCT01183234|147547941|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.988|||||TWO_SIDED|90.0|0.931|1.05|||Mixed Models Analysis|||||1.05|0.931|
73999650|NCT01183234|147547942|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.15|0.492|||Wilcoxon (Hodges-Lehmann)|||||0.492|-0.150|
73999651|NCT00704379|147547943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.6|||<|0.05|TWO_SIDED|95.0|1.1|16.2|||Log Rank|||||16.2|1.1|<0.05
74036650|NCT01089582|147626615|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.||||<0.0001
74036651|NCT02108600|147626619|OTHER|||||||0.033|TWO_SIDED|95.0|||||Fisher Exact|||||||0.033
74036652|NCT02724774|147626641|SUPERIORITY|||||||0.026||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||All analyses were conducted as intention-to-treat, analyzing all 252 cases as randomly assigned to the PFR and control group (CG). Multiple linear regression was used to examine the treatment effect of PFR (0 = CG, 1 = PFR). Covariates included preferred language (0 = English, 1 = Spanish) and the baseline measure.||||.026
74036653|NCT02724774|147626642|SUPERIORITY|||||||0.154||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.154
73999652|NCT02937454|147547951|OTHER||Annualised event rate ratio (RR)|0.79||||0.059|TWO_SIDED|95.0|0.62|1.01|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||1.01|0.62|0.059
73999653|NCT02937454|147547951|OTHER||Annualised event rate ratio (RR)|0.75||||0.024|TWO_SIDED|95.0|0.59|0.96|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Covid-19 Sensitivity Analysis||0.96|0.59|0.024
73999654|NCT02937454|147547952|OTHER||Annualised event rate ratio (RR)|0.8||||0.05|TWO_SIDED|95.0|0.64|1.0|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||1.0|0.64|0.050
73999655|NCT02937454|147547952|OTHER||Annualised event rate ratio (RR)|0.77||||0.024|TWO_SIDED|95.0|0.62|0.97|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||COVID-19 sensitivity analyses||0.97|0.62|0.024
73999656|NCT02937454|147547953|OTHER||Annualised event rate ratio (RR)|0.74||||0.013|TWO_SIDED|95.0|0.58|0.94|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||0.94|0.58|0.013
73999657|NCT02937454|147547953|OTHER||Annualised event rate ratio (RR)|0.7||||0.005|TWO_SIDED|95.0|0.55|0.9|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||COVID-19 sensitivity analyses||0.90|0.55|0.005
73999658|NCT02937454|147547954|OTHER||Hazard Ratio (HR)|0.96||||0.809|TWO_SIDED|95.0|0.7|1.32|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||1.32|0.70|0.809
73999659|NCT02937454|147547954|OTHER||Hazard Ratio (HR)|0.94||||0.687|TWO_SIDED|95.0|0.68|1.29|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Covid-19 Sensitivity Analysis||1.29|0.68|0.687
74036654|NCT02724774|147626643|SUPERIORITY|||||||0.516||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.516
74036655|NCT02724774|147626644|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||<0.001
74036656|NCT02724774|147626645|SUPERIORITY|||||||0.094||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||0.094
74036657|NCT02724774|147626646|SUPERIORITY|||||||0.029|||||||Regression, Linear|||||||0.029
74036658|NCT02724774|147626647|SUPERIORITY|||||||0.389||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.389
74036659|NCT02724774|147626648|SUPERIORITY|||||||0.747||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.747
74036660|NCT02130258|147626650|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||.04
74036661|NCT02130258|147626651|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||.04
74036662|NCT02130258|147626652|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||0.04
74036663|NCT05836818|147626655|SUPERIORITY||Adjusted difference|25.1|||<|0.0001|TWO_SIDED|95.0|17.0|33.2|||Regression, Logistic|Mixed effects logistic regression with a random center effect for within-center characteristics, and terms for calendar time and intervention||Adjusted difference 25.1 percentage points||33.2|17|<0.0001
73877131|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|25.0||||0.619|TWO_SIDED|95.0|-22.4|72.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||72.4|-22.4|0.619
73877132|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.0|-66.0|1.000
73877133|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|75.0||||0.133|TWO_SIDED|95.0|45.0|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||100.0|45.0|0.133
73999660|NCT02937454|147547955|OTHER||Hazard Ratio (HR)|0.8||||0.03|TWO_SIDED|95.0|0.66|0.98|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Full Analysis Set (FAS)||0.98|0.66|0.030
73999661|NCT02937454|147547955|OTHER||Hazard Ratio (HR)|0.79||||0.023|TWO_SIDED|95.0|0.65|0.97|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Covid-19 Sensitivity Analysis||0.97|0.65|0.023
73999662|NCT02937454|147547956|OTHER||Annualised event rate ratio (RR)|0.67||||0.035|TWO_SIDED|95.0|0.47|0.97|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||0.97|0.47|0.035
73999663|NCT02937454|147547956|OTHER||Annualised event rate ratio (RR)|0.61||||0.009|TWO_SIDED|95.0|0.42|0.88|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country||Covid-19 Sensitivity Analysis||0.88|0.42|0.009
73999664|NCT02937454|147547957|OTHER||Hazard Ratio (HR)|0.73||||0.006|TWO_SIDED|95.0|0.59|0.92|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||0.92|0.59|0.006
73999665|NCT02937454|147547958|OTHER||Hazard Ratio (HR)|0.77||||0.009|TWO_SIDED|95.0|0.63|0.94|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||0.94|0.63|0.009
73999666|NCT02937454|147547959|OTHER||Hazard Ratio (HR)|0.99||||0.944|TWO_SIDED|95.0|0.75|1.31|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Full Analysis Set (FAS)||1.31|0.75|0.944
74036664|NCT03977727|147626659|SUPERIORITY||Mean Difference (Final Values)|27.35||||0.008|TWO_SIDED|95.0|7.88|48.4|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||48.4|7.88|.008
74036665|NCT03977727|147626660|SUPERIORITY||Mean Difference (Final Values)|15.22||||0.136|TWO_SIDED|95.0|-5.42|39.46|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||39.46|-5.42|.136
73877134|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|37.5||||0.315|TWO_SIDED|95.0|-7.5|82.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||82.5|-7.5|0.315
73999667|NCT02937454|147547960|OTHER||Odds Ratio (OR)|1.14||||0.196|TWO_SIDED|95.0|0.93|1.39|||Generalised Estimating Equations (GEE)|The following variables are included in the GEE model: treatment, visit, baseline NYHA class, sex, age, HF aetiology, HF duration, and country||Full Analysis Set (FAS)||1.39|0.93|0.196
73999668|NCT02937454|147547961|OTHER|||||||0.208|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 6||||0.208
73999669|NCT02937454|147547961|OTHER|||||||0.408|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 24||||0.408
73999670|NCT02937454|147547961|OTHER|||||||0.999|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 52||||0.999
73999671|NCT02937454|147547962|OTHER|||||||0.227|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 2||||0.227
73999672|NCT02937454|147547962|OTHER|||||||0.018|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 4||||0.018
73999673|NCT02937454|147547962|OTHER|||||||0.005|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 6||||0.005
73999674|NCT02937454|147547962|OTHER|||||||0.006|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 12||||0.006
73999675|NCT02937454|147547962|OTHER|||||||0.028|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 24||||0.028
73999676|NCT02937454|147547962|OTHER|||||||0.136|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 36||||0.136
74036666|NCT03977727|147626661|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.029|TWO_SIDED|95.0|0.05|0.73|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||.73|.05|.029
73999677|NCT02937454|147547962|OTHER|||||||0.329|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 52||||0.329
73999678|NCT00560560|147547963|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||The final analysis was intended to be a binomial test (death prior to 6 months, yes or no). However, 2 participants in the 30/kg mg group were censored prior to 6 months, so the six month Kaplan and Meier estimates were used for each group instead.|Test of probability of 6 month survival|p-Value \>0.05 applies to each group (20 mg/kg and 30 mg/kg). Greenwood's formula was used for standard deviation.||The hypotheses for each group were H0:p=0.45 vs H1:p\>0.45. There was one interim analysis for futility for each group based on the method of Case and Morgan. The futility boundary was not crossed for 20/kg mg group, but was crossed for the 30/kg mg group. It was recommended to investigators that participants be discontinued from treatment with 30 mg/kg of figitumumab.||||>0.05
73999679|NCT00037830|147547971|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The null hypothesis for Phase I was that at week 24, there is no difference between UPDRS motor scores in placebo vs. GM1-treated subjects.||||<0.0001
73999680|NCT00037830|147547972|SUPERIORITY_OR_OTHER|||||||0.0368|||||||t-test, 2 sided|||The null hypothesis for Phase II is that long-term use of GM1 does not affect the progression of PD symptoms and that there is no benefit to early start of GM1 use.||||0.0368
73999681|NCT00037830|147547973|SUPERIORITY_OR_OTHER|||||||0.1903|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure||||||0.1903
73999682|NCT00037830|147547973|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||estimate slope of change over time|random intercept model and a variance components covariance structure||||||0.0063
73999683|NCT00037830|147547974|SUPERIORITY_OR_OTHER|||||||0.0502|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure||||||0.0502
73999684|NCT00037830|147547974|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||estimate slope of change over time|random intercept model and a variance components covariance structure||||||0.0003
74036667|NCT03977727|147626662|SUPERIORITY||Mean Difference (Final Values)|-1.81||||0.016|TWO_SIDED|95.0|-2.84|-0.31|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||-0.31|-2.84|.016
74036668|NCT03977727|147626663|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.045|TWO_SIDED|95.0|0.04|2.32|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||2.32|.04|.045
74036669|NCT03977727|147626666|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.303|TWO_SIDED|95.0|-0.59|0.16|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||.16|-.59|.303
74036670|NCT03977727|147626667|SUPERIORITY||Mean Difference (Final Values)|-1.18||||0.968|TWO_SIDED|95.0|-10.32|9.99|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||9.99|-10.32|.968
74036671|NCT03977727|147626668|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.059|TWO_SIDED|95.0|-0.13|0.0|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||0|-.13|.059
74036672|NCT00621855|147626679|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"||||<0.001
74036673|NCT00621855|147626682|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"||||<0.001
74036674|NCT00403559|147626705|NON_INFERIORITY|Non-inferiority determined as the F-IGA, IGA, erythema, scaling, and pruritis scores when compared between groups. The Wilcoxon rank sum test stratified baseline seborrheic dermatitis (SD) severity.||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
73999685|NCT00037830|147547975|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73999686|NCT00037830|147547976|SUPERIORITY_OR_OTHER|||||||0.131|||||||t-test, 2 sided|||||||0.1310
73999687|NCT00037830|147547977|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Analysis was paired sample t-test on change from baseline.||||<0.05
73999688|NCT00037830|147547978|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
73999689|NCT00037830|147547979|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
73999690|NCT00037830|147547980|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
74036675|NCT04633473|147626749|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.922|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.922
74036676|NCT04633473|147626750|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.521|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.521
74036677|NCT04633473|147626751|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.678|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.678
74036678|NCT04633473|147626752|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.326|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.326
74036679|NCT04633473|147626753|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.09|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.09
74036680|NCT04633473|147626754|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.154|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.154
74036681|NCT04633473|147626755|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.309|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.309
74036682|NCT04633473|147626757|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.181|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.181
74036683|NCT04633473|147626758|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.008|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.008
73999691|NCT03292432|147547981|SUPERIORITY||Risk Difference (RD)|-3.5||||0.8|TWO_SIDED|95.0|-21.8|15.2|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 50 copies/mL in TERA arm minus SOC arm|||15.2|-21.8|0.80
73999692|NCT03292432|147547982|SUPERIORITY||Risk Difference (RD)|-0.7|||>|0.99|TWO_SIDED|95.0|-20.9|19.6|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 200 copies/ml in TERA arm minus SOC arm|||19.6|-20.9|>0.99
73999693|NCT03292432|147547983|SUPERIORITY||Risk Difference (RD)|-13.1||||0.24|TWO_SIDED|95.0|-32.1|7.2|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 in TERA arm minus SOC arm|Comparison of percentages at Week 24||7.2|-32.1|0.24
73999694|NCT03292432|147547983|SUPERIORITY||Risk Difference (RD)|3.8||||0.76|TWO_SIDED|95.0|-16.0|22.6|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 36 in TERA arm minus SOC arm|Comparison of percentages at Week 36||22.6|-16.0|0.76
73999695|NCT03292432|147547983|SUPERIORITY||Risk Difference (RD)|3.6|||>|0.99|TWO_SIDED|95.0|-21.8|27.4|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in TERA arm minus SOC arm|Comparison of percentages at Week 48||27.4|-21.8|>0.99
73877135|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||5.0|-55.0|0.487
73999696|NCT03292432|147547984|SUPERIORITY||Risk Difference (RD)|-13.0||||0.26|TWO_SIDED|95.0|-32.7|7.3|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 24 in TERA arm minus SOC arm|Comparison of percentages at Week 24||7.3|-32.7|0.26
73999697|NCT03292432|147547984|SUPERIORITY||Risk Difference (RD)|11.5||||0.42|TWO_SIDED|95.0|-11.2|32.8|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 36 in TERA arm minus SOC arm|Comparison of percentages at Week 36||32.8|-11.2|0.42
74036684|NCT00242385|147626766|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To establish bioequivalence in AUC 0-35d divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.928|||||TWO_SIDED|90.0|0.858|1.002||||||||1.002|0.858|
74036685|NCT00242385|147626767|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To establish bioequivalence in AUC 0-infinity divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.934|||||TWO_SIDED|90.0|0.855|1.021||||||||1.021|0.855|
74036686|NCT04348591|147626780|SUPERIORITY||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.037||0.221|TWO_SIDED|95.0|-0.12|0.029||This p value corresponds to the main effect for experimental group; a-priori threshold was .012|Mixed Models Analysis|||A MMANOVA analysis using an unstructured covariance structure examined main effects of experimental group, instruction provided, headache, racial background, and type of neurostimulation administered. HF-HRV was transformed using an lg function for normality.||.029|-.12|.221
73999698|NCT03292432|147547984|SUPERIORITY||Risk Difference (RD)|-4.4||||0.77|TWO_SIDED|95.0|-29.5|20.7|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 48 in TERA arm minus SOC arm|Comparison of percentages at Week 48||20.7|-29.5|0.77
73999699|NCT03292432|147547985|SUPERIORITY||Risk Difference (RD)|5.8||||0.67|TWO_SIDED|95.0|-14.6|25.3|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 12 and maintained to Week 48 in TERA arm minus SOC arm|||25.3|-14.6|0.67
73999700|NCT03292432|147547986|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentages of doses taken from Weeks 0 -12||||<0.001
73999701|NCT03292432|147547986|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>12 to 24||||<0.001
73999702|NCT03292432|147547986|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>24 to 36||||0.06
73999703|NCT03292432|147547986|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>36 to 48||||0.50
73999704|NCT03292432|147547987|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken on time from Weeks 0 - 12||||<0.001
73999705|NCT03292432|147547987|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken on time from Weeks \>12 - 24||||<0.001
73877136|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||72.9|-19.6|0.249
73877137|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-13.3||||0.487|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.487
73877138|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-13.3||||0.511|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.511
73877139|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|33.3||||0.14|TWO_SIDED|95.0|-11.4|78.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||78.1|-11.4|0.140
73877140|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|10.0||||0.569|TWO_SIDED|95.0|-14.6|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||34.6|-14.6|0.569
73999706|NCT03292432|147547987|SUPERIORITY|||||||0.05||||||p-value equal to a priori threshold for statistical significance|Wilcoxon (Mann-Whitney)|||Comparison of percentages of doses taken on time from Weeks \>24 - 36||||0.05
73999707|NCT03292432|147547987|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Comparison of doses taken on time from Weeks \>36 - 48||||0.49
73999708|NCT03292432|147547988|SUPERIORITY||Risk Ratio (RR)|2.51|||<|0.001|TWO_SIDED|95.0|1.9|3.33|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks 0 - 12||3.33|1.90|<0.001
73999709|NCT03292432|147547988|SUPERIORITY||Risk Ratio (RR)|1.56|||<|0.001|TWO_SIDED|95.0|1.29|1.89|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks \>12 - 24||1.89|1.29|<0.001
73877141|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.5|-19.7|1.000
73877142|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|13.3||||0.447|TWO_SIDED|95.0|-23.9|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.6|-23.9|0.447
73877143|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-19.3|6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||6.0|-19.3|1.000
73999710|NCT03292432|147547988|SUPERIORITY||Risk Ratio (RR)|1.23||||0.02|TWO_SIDED|95.0|1.03|1.47|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|P-value from Pearson Chi-square test from generalized linear model with Poisson link|Comparison of incidence rates from Weeks \>24 - 36||1.47|1.03|0.020
73999711|NCT03292432|147547988|SUPERIORITY||Risk Ratio (RR)|1.08||||0.39|TWO_SIDED|95.0|0.9|1.3|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks \>36 - 48||1.30|0.90|0.39
73999712|NCT03292432|147547989|SUPERIORITY||Risk Difference (RD)|2.3|||>|0.99|TWO_SIDED|95.0|-16.4|21.1|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 200 copies/mL in TERA arm minus SOC arm|||21.1|-16.4|>0.99
73999713|NCT03292432|147547990|SUPERIORITY||Risk Difference (RD)|4.7||||0.71|TWO_SIDED|95.0|-9.0|19.4|||Fisher Exact||Risk difference reflects percentage of participants achieving sustained virologic control in TERA arm minus SOC arm|||19.4|-9.0|0.71
73999714|NCT01014143|147547997|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73877144|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||28.5|-19.7|1.000
73877145|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|20.0||||0.56|TWO_SIDED|95.0|-27.5|67.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||67.5|-27.5|0.560
73999715|NCT00495586|147547998|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence.|Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|9.5|<|0.05|TWO_SIDED|95.0|3.7|24.3|||Chi-squared|||For the comparison of the efficacy of antibiotic versus placebo, we accepted a null hypothesis if the cure rate in the intervention group was the same or ±7% as that observed in the placebo arm. Based on previous studies, the expected rate of cure among patients assigned to antibiotic therapy was 90%. For an alpha of 0.05 and a beta of 0.2 and accepting possible losses of 15%, we calculated that the sample size is 677 patients in total.||24.3|3.7|<0.05
73999716|NCT00158860|147548002|SUPERIORITY||Kaplan-Meier estimates|27.3|||<|0.001|TWO_SIDED|95.0|16.0|38.6|||Log Rank|||||38.6|16.0|<0.001
73999717|NCT00158860|147548002|SUPERIORITY||Hazard Ratio (HR)|0.401|||<|0.001|TWO_SIDED|95.0|0.282|0.57|||Log Rank|||||0.570|0.282|<0.001
73999718|NCT00158860|147548003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon rank sum test|||||||<0.001
73999719|NCT03618823|147548047|EQUIVALENCE|All pain scores were included due to the sample size. Alpha =.05 Power = .80 Desired effect size of 0.30 Size of n=145 in each group was determined, however this was not reached for sufficient power.||||||0.912|||||||Mixed Models Analysis|Two-way mixed-model analysis of variance||There will be no difference in pain scores between opioid and non-opioid groups from before medication to after while controlling for total duration of mediation use (duration mean=10.11 days).||||.912
73999720|NCT03618823|147548048|SUPERIORITY||Odds Ratio (OR)|1.311||||0.63|TWO_SIDED|95.0|0.494|3.478|||Fisher Exact|||There will be no difference in ED (Emergency Department) or urgent care visits between opioid and non-opioid pain control groups.||3.478|.494|.630
73999721|NCT00964886|147548066|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANCOVA|||In an intent-to-treat analysis of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance compared mean Descriptor Differential Scale scores at 12 weeks (or last observation carried forward) adjusted fro mean baseline score ( = ).||||0.7
74036687|NCT04348591|147626780|SUPERIORITY|This is a within subject analysis that uses data across groups, controlling for the effect of neurostimulation alone, coil to cortex distance, and racial background|Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.008|TWO_SIDED|95.0|0.016|0.103|||Mixed Models Analysis|Comparison between sham neurostimulation and high frequency neurostimulation||A MMANOVA analysis using an unstructured covariance examined the main effect of type of neurostimulation provided||.103|.016|.008
73877146|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-20.0||||0.231|TWO_SIDED|95.0|-40.2|0.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||0.2|-40.2|0.231
73999722|NCT00964886|147548067|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|Means are adjusted for baseline Roland and Morris scores.||In the intent-to-treat sample of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance (ANOVA) compared mean Roland and Morris scores at 12 weeks adjusted for mean baseline scores.||||0.84
73999723|NCT00964886|147548068|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANCOVA|||||||0.6
73999724|NCT00964886|147548069|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANCOVA|||This analysis compares outcomes for participants assigned at baseline to receive cognitive behavioral therapy or not to receive cognitive behavioral therapy (behavioral effect)||||0.8
73999725|NCT00523640|147548073|SUPERIORITY_OR_OTHER||Proportion responding|0.24|||||TWO_SIDED|95.0|0.1|0.44||||||||0.44|0.10|
73999726|NCT01859988|147548087|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-55.7|STANDARD_ERROR_OF_MEAN|6.74|<|0.0001|TWO_SIDED|95.0|-68.9|-42.4||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|LS mean and standard error were obtained using analysis of covariance (ANCOVA) model with treatment and randomization strata (moderate vs severe;Japan vs rest of world) and relevant baseline values as covariates. Multiplicity was controlled using hierarchical testing procedure:highest dose vs. placebo was tested first. Comparison order was 300 mg qw,300 mg q2w,200 mg q2w,300 mg q4w \& 100 mg q4w, vs placebo respectively. Testing continues only if previous comparison was statistically significant.||-42.4|-68.9|<0.0001
73999727|NCT01859988|147548087|SUPERIORITY_OR_OTHER||LS mean difference|-50.1|STANDARD_ERROR_OF_MEAN|6.67|<|0.0001|TWO_SIDED|95.0|-63.3|-37.0||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-37.0|-63.3|<0.0001
73999728|NCT01859988|147548087|SUPERIORITY_OR_OTHER||LS mean difference|-47.4|STANDARD_ERROR_OF_MEAN|6.76|<|0.0001|TWO_SIDED|95.0|-60.6|-34.1||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 200 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.1|-60.6|<0.0001
73999729|NCT01859988|147548087|SUPERIORITY_OR_OTHER||LS mean difference|-45.4|STANDARD_ERROR_OF_MEAN|6.66|<|0.0001|TWO_SIDED|95.0|-58.5|-32.3||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.3|-58.5|<0.0001
73999730|NCT01859988|147548087|SUPERIORITY_OR_OTHER||LS mean difference|-26.8|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|-39.8|-13.7||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 100 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.7|-39.8|<0.0001
73999731|NCT02065687|147548108|EQUIVALENCE|The null hypothesis is that there is no relationship between BMI and metformin treatment (i.e. the parameter associated with the interaction term of BMI \* treatment is equal to 0).|Cox Proportional Hazard|-0.01787|STANDARD_ERROR_OF_MEAN|0.27472||0.9482|TWO_SIDED||||||Regression, Cox|||The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model. Historical data indicate that approximately 50% of people are obese (BMI\>=30). For the purposes of examining the relationship, we will classify patients into two levels (high versus low) at the median BMI, which will increase the likelihood of detecting an interaction between metformin treatment and obesity.||||0.9482
73999732|NCT04602221|147548129|OTHER||Difference of adjusted means|-0.339|STANDARD_ERROR_OF_MEAN|3.8242||0.9296|TWO_SIDED|95.0|-7.975|7.297|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||7.297|-7.975|0.9296
73999733|NCT04602221|147548129|OTHER||Difference of adjusted means|4.002|STANDARD_ERROR_OF_MEAN|3.8224||0.299|TWO_SIDED|95.0|-3.631|11.634|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||11.634|-3.631|0.2990
73999734|NCT04602221|147548129|OTHER||Difference of adjusted means|-1.258|STANDARD_ERROR_OF_MEAN|3.6608||0.7322|TWO_SIDED|95.0|-8.565|6.05|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||6.050|-8.565|0.7322
73999735|NCT04602221|147548130|OTHER||Difference of adjusted means|0.347|STANDARD_ERROR_OF_MEAN|1.563||0.8249|TWO_SIDED|95.0|-2.776|3.471|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||3.471|-2.776|0.8249
73999736|NCT04602221|147548130|OTHER||Difference of adjusted means|-1.085|STANDARD_ERROR_OF_MEAN|1.5889||0.4973|TWO_SIDED|95.0|-4.26|2.091|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||2.091|-4.260|0.4973
73999737|NCT04602221|147548130|OTHER||Difference of adjusted means|-2.858|STANDARD_ERROR_OF_MEAN|1.5266||0.0658|TWO_SIDED|95.0|-5.909|0.192|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.192|-5.909|0.0658
73999738|NCT04602221|147548131|OTHER||Difference of adjusted means|0.0053|STANDARD_ERROR_OF_MEAN|0.00798||0.5081|TWO_SIDED|95.0|-0.0106|0.0213|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0213|-0.0106|0.5081
73999739|NCT04602221|147548131|OTHER||Difference of adjusted means|0.0058|STANDARD_ERROR_OF_MEAN|0.00798||0.4723|TWO_SIDED|95.0|-0.0102|0.0217|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0217|-0.0102|0.4723
73999740|NCT04602221|147548131|OTHER||Difference of adjusted means|0.0333|STANDARD_ERROR_OF_MEAN|0.00767|<|0.0001|TWO_SIDED|95.0|0.018|0.0486|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0486|0.0180|< .0001
73999741|NCT03538301|147548133|SUPERIORITY||Slope|-0.004153||||0.049|TWO_SIDED|95.0|-0.008284|-0.000021|||random coefficient model|||Slope in FVC (L/week) in the 45 mg cohort versus placebo||-0.000021|-0.008284|0.049
73999742|NCT03538301|147548133|SUPERIORITY||Slope|-0.002112||||0.316|TWO_SIDED|95.0|-0.00626|0.002036|||random coefficient model|||Slope in FVC (L/week) in the 90 mg cohort versus placebo||0.002036|-0.006260|0.316
73999743|NCT03538301|147548134|SUPERIORITY||Slope|-0.091238||||0.098|TWO_SIDED|95.0|-0.199456|0.016979|||random coefficient model|||||0.016979|-0.199456|0.098
73999744|NCT03538301|147548134|SUPERIORITY||Slope|-0.039596||||0.473|TWO_SIDED|95.0|-0.148248|0.069056|||random coefficient model|||||0.069056|-0.148248|0.473
73999745|NCT03538301|147548135|SUPERIORITY||Mean Difference (Final Values)|-0.0997||||0.049|TWO_SIDED|95.0|-0.1988|-0.0005|||random coefficient model|||Change from Baseline to Week 24 in FVC (L) in the 45 mg cohort versus placebo||-0.0005|-0.1988|0.049
73999746|NCT03538301|147548135|SUPERIORITY||Mean Difference (Final Values)|-0.0507||||0.316|TWO_SIDED|95.0|-0.1502|0.0489|||random coefficient model|||Change from Baseline to Week 24 in FVC (L) in the 90 mg cohort versus placebo||0.0489|-0.1502|0.316
73999747|NCT03538301|147548136|SUPERIORITY||Median Difference (Final Values)|-3.16||||0.668|TWO_SIDED|95.0|-17.59|11.28|||random coefficient model|||||11.28|-17.59|0.668
73999748|NCT03538301|147548136|SUPERIORITY||Median Difference (Final Values)|-1.72||||0.821|TWO_SIDED|95.0|-16.57|13.13|||random coefficient model|||||13.13|-16.57|0.821
73999749|NCT03538301|147548137|SUPERIORITY||Median Difference (Final Values)|-2.1897||||0.098|TWO_SIDED|95.0|-4.7869|0.4075|||random coefficient model|||Change from baseline to Week 24 in ppFVC||0.4075|-4.7869|0.098
73999750|NCT03538301|147548137|SUPERIORITY||Median Difference (Final Values)|-0.9503||||0.473|TWO_SIDED|95.0|-3.5579|1.6573|||random coefficient model|||Change from Baseline to Week 24 in ppFVC||1.6573|-3.5579|0.473
73999751|NCT03538301|147548138|SUPERIORITY||Median Difference (Final Values)|-2.53||||0.7|TWO_SIDED|95.0|-15.4|10.34|||random coefficient model|||||10.34|-15.40|0.700
73999752|NCT03538301|147548138|SUPERIORITY||Median Difference (Final Values)|-1.12||||0.867|TWO_SIDED|95.0|-14.31|12.07|||random coefficient model|||||12.07|-14.31|0.867
73999753|NCT03538301|147548141|SUPERIORITY||Mean Difference (Final Values)|0.146||||0.708|TWO_SIDED|95.0|-0.6226|0.9147|||random coefficient|||Change from Baseline to Week 24 in DLCO Corrected for Hemoglobin (mL/min/mmHg) in the 45 mg cohort versus placebo||0.9147|-0.6226|0.708
73999754|NCT03538301|147548141|SUPERIORITY||Mean Difference (Final Values)|0.7038||||0.074|TWO_SIDED|95.0|-0.0695|1.4771|||random coefficient|||Change from Baseline to Week 24 in DLCO Corrected for Hemoglobin (mL/min/mmHg) in the 90 mg cohort versus placebo||1.4771|-0.0695|0.074
73999755|NCT03538301|147548141|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.765|TWO_SIDED|95.0|-0.6362|0.8641|||random coefficient model|||Change from Baseline to Week 24 in DLCO Not Corrected for Hemoglobin (mL/min/mmHg) in the 45 mg cohort versus placebo||0.8641|-0.6362|0.765
73999756|NCT03538301|147548141|SUPERIORITY||Mean Difference (Final Values)|0.556||||0.148|TWO_SIDED|95.0|-0.1986|1.3107|||random coefficient model|||Change from Baseline to Week 24 in DLCO Not Corrected for Hemoglobin (mL/min/mmHg) in the 90 mg cohort versus placebo||1.3107|-0.1986|0.148
73999757|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.765|TWO_SIDED|95.0|-3.68|2.71|||random coefficient model|||Change from Baseline to Week 24 in QLF Score (% of whole lung field volume) in the 45 mg cohort versus placebo||2.71|-3.68|0.765
73999758|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.37|TWO_SIDED|95.0|-1.68|4.47|||random coefficient model|||Change from Baseline to Week 24 in QLF Score (% of whole lung field volume) in the 90 mg cohort versus placebo||4.47|-1.68|0.370
73999759|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.499|TWO_SIDED|95.0|-0.7|0.34|||random coefficient model|||Change from Baseline to Week 24 in Ground Glass Opacity (% of whole lung field volume) in the 45 mg cohort versus placebo||0.34|-0.70|0.499
73999760|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.901|TWO_SIDED|95.0|-0.47|0.54|||random coefficient model|||Change from Baseline to Week 24 in Ground Glass Opacity (% of whole lung field volume) in the 90 mg cohort versus placebo||0.54|-0.47|0.901
73999761|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.676|TWO_SIDED|95.0|-2.25|3.46|||random coefficient model|||Change from Baseline to Week 24 in Reticulation (% of whole lung field volume) in the 45 mg cohort versus placebo||3.46|-2.25|0.676
73999762|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|1.64||||0.242|TWO_SIDED|95.0|-1.13|4.42|||random coefficient model|||Change from Baseline to Week 24 in Reticulation (% of whole lung field volume) in the 90 mg cohort versus placebo||4.42|-1.13|0.242
73999763|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.14|TWO_SIDED|95.0|-2.82|0.4|||random coefficient model|||Change from Baseline to Week 24 in Honeycombing (% of whole lung field volume) in the 45 mg cohort versus placebo||0.40|-2.82|0.140
73999764|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.211|TWO_SIDED|95.0|-2.53|0.56|||random coefficient model|||Change from Baseline to Week 24 in Honeycombing (% of whole lung field volume) in the 90 mg cohort versus placebo||0.56|-2.53|0.211
73999765|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.568|TWO_SIDED|95.0|-2.16|3.91|||random coefficient model|||Change from Baseline to Week 24 in Normal Lung (% of whole lung field volume) in the 45 mg cohort versus placebo||3.91|-2.16|0.568
73999766|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.573|TWO_SIDED|95.0|-3.76|2.09|||random coefficient model|||Change from Baseline to Week 24 in Normal Lung (% of whole lung field volume) in the 90 mg cohort versus placebo||2.09|-3.76|0.573
73999767|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|-3.58||||0.012|TWO_SIDED|95.0|-6.35|-0.81|||random coefficient model|||Change from Baseline to Week 24 in Emphysema (% of whole lung field volume) in the 45 mg cohort versus placebo||-0.81|-6.35|0.012
73999768|NCT03538301|147548142|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.112|TWO_SIDED|95.0|-4.82|0.51|||random coefficient model|||Change from Baseline to Week 24 in Emphysema (% of whole lung field volume) in the 90 mg cohort versus placebo||0.51|-4.82|0.112
73999769|NCT03538301|147548143|SUPERIORITY|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||||||0.256
73999770|NCT03538301|147548143|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|||||||0.241
73999771|NCT03538301|147548144|SUPERIORITY||Hazard Ratio (HR)|0.649||||0.517|TWO_SIDED|95.0|0.189|2.225|||Log Rank|||Time to First IPF Exacerbation or Death (weeks) in the 45 mg cohort versus placebo||2.225|0.189|0.517
73999772|NCT03538301|147548144|SUPERIORITY||Hazard Ratio (HR)|0.678||||0.506|TWO_SIDED|95.0|0.198|2.324|||Log Rank|||Time to First IPF Exacerbation or Death (weeks) in the 90 mg cohort versus placebo||2.324|0.198|0.506
73999773|NCT03538301|147548144|SUPERIORITY||Proportion Difference (Final Values)|-9.3||||0.313|TWO_SIDED|95.0|-25.2|5.5|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of First IPF Exacerbation (%) in the 45 mg cohort versus placebo||5.5|-25.2|0.313
73999774|NCT03538301|147548144|SUPERIORITY|The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Proportion Difference (Final Values)|-6.7||||0.376|TWO_SIDED|95.0|-22.6|9.2|||Chi-squared|||Rate of First IPF Exacerbation (%) in the 90 mg cohort versus placebo||9.2|-22.6|0.376
73999775|NCT03538301|147548145|SUPERIORITY||Proportion Difference (Final Values)|-4.6||||0.713|TWO_SIDED|95.0|-19.2|9.6|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Hospitalization for Respiratory Ailments (%) in the 45 mg cohort versus placebo||9.6|-19.2|0.713
73999776|NCT03538301|147548145|SUPERIORITY||Proportion Difference (Final Values)|-4.4||||0.713|TWO_SIDED|95.0|-19.2|10.7|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Hospitalization for Respiratory Ailments (%) in the 90 mg cohort versus placebo||10.7|-19.2|0.713
73999777|NCT03538301|147548146|SUPERIORITY|||||||0.937|||||||Log Rank|||Overall Survival (weeks) in the 45 mg cohort versus placebo||||0.937
73999778|NCT03538301|147548146|SUPERIORITY|||||||0.414|||||||Log Rank|||Overall Survival (weeks) in the 90 mg cohort versus placebo||||0.414
73999779|NCT03538301|147548146|SUPERIORITY||Proportion Difference (Final Values)|0.1|||>|0.999|TWO_SIDED|95.0|-10.4|10.9|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Mortality (%) in the 45 mg cohort versus placebo||10.9|-10.4|>0.999
73999780|NCT03538301|147548146|SUPERIORITY||Proportion Difference (Final Values)|-2.4|||>|0.999|TWO_SIDED|95.0|-13.1|6.8|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Mortality (%) in the 90 mg cohort versus placebo||6.8|-13.1|>0.999
73999781|NCT03538301|147548147|SUPERIORITY||Proportion Difference (Final Values)|-4.8||||0.494|TWO_SIDED|95.0|-16.6|4.6|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Deterioration of IPF Resulting in Lung Transplantation (%) in the 45 mg cohort versus placebo||4.6|-16.6|0.494
73999782|NCT03538301|147548147|SUPERIORITY||Proportion Difference (Final Values)|-4.8||||0.494|TWO_SIDED|95.0|-16.2|4.5|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Deterioration of IPF Resulting in Lung Transplantation (%) in the 90 mg cohort versus placebo||4.5|-16.2|0.494
73877147|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-8.9||||1|TWO_SIDED|95.0|-37.7|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||19.9|-37.7|1.000
73999783|NCT00515853|147548157|SUPERIORITY|||||||0.54|||||||Regression, Linear|||CCI final||||0.54
73999784|NCT00589121|147548160|SUPERIORITY_OR_OTHER|The fixed rate of 37% comes from the published National Cancer Institute of Canada trial SR2 (CAN-NCIC-SR2: Phase III Randomized Study of Pre- vs Postoperative Radiotherapy in Curable Extremity Soft Tissue Sarcoma) receiving preoperative radiation therapy without image-guided radiation therapy (IGRT).||||||0.0005|||||||Fisher Exact|||Initially designed to test for a 20% absolute improvement from 37% (fixed rate) to 17% using Fisher's exact test, requiring 41 patients per cohort (51 with 20% ineligibility) with 5% type I error and 90% statistical power. During accrual, the sample size for cohort B was increased to 66 (83 with 20% ineligibility) to test for a 15% improvement with 5% type I error and 85% power.||||0.0005
73999785|NCT03924765|147548190|OTHER|A one-way repeated measures analysis of variance (ANOVA) was performed on different exoskeleton assistance strategies (including the baseline of not wearing the exoskeleton) on the subject's overground self-selected walking speed by setting an alpha value to 0.05.||||||5e-06|||||||ANOVA|||Primary Outcome Measure - Arm/Group 1||||0.000005
73999786|NCT03924765|147548191|OTHER|A one-way repeated measures analysis of variance (ANOVA) was performed on different exoskeleton assistance strategies (including the baseline of not wearing the exoskeleton) on the subject's step length asymmetry by setting an alpha value to 0.05.||||||0.131|||||||ANOVA|||Secondary Outcome Measure - Arm/Group 1||||0.131
73999787|NCT04548544|147548192|OTHER|||||||0.38|||||||ANOVA|||timepoint × group interaction|timepoint × group interaction F = 0.77, p = 0.38|||0.38
73999788|NCT01370590|147548211|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet was considered equivalent to co-administration of ezetimibe 10 mg and atorvastatin 20 mg, if the two-sided 97.5% expanded confidence intervals of the treatment difference in least squares means for percent change in LDL-C from baseline after 6 weeks of treatment (combination minus co-administration) was contained within -4% and 4% (equivalence margins).|Difference in Least-square Means|-0.2|||||TWO_SIDED|97.5|-1.7|3.3|||ANCOVA|||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.4% and that the standard deviation of the difference is 12.8%.||3.3|-1.7|
73999789|NCT01370590|147548212|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-square means|0.3|||||TWO_SIDED|97.5|-0.8|1.4|||ANCOVA|||||1.4|-0.8|
73999790|NCT01370590|147548213|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|0.8|||||TWO_SIDED|97.5|-0.6|2.2|||ANCOVA|||||2.2|-0.6|
73999791|NCT01370590|147548214|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.0|||||TWO_SIDED|97.5|-1.3|1.4|||ANCOVA|||||1.4|-1.3|
73999792|NCT01370590|147548215|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.7|||||TWO_SIDED|97.5|-0.6|1.9|||ANCOVA|||||1.9|-0.6|
73999793|NCT01370590|147548216|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|1.6|||||TWO_SIDED|97.5|-3.2|6.3|||Constrained Longitudinal Data Analysis|||Analyses were based on log-transformed data.||6.3|-3.2|
73999794|NCT05172050|147548217|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Odds Ratio (OR)|9.99||||0.0109|TWO_SIDED|95.0|1.781||Upper limit is not estimable (NE) due to the low number of events||Regression, Logistic||||||1.781|0.0109
74036688|NCT04348591|147626780|SUPERIORITY|The analysis controls for coil to cortex distance, racial background and effect of neurostimulation alone. It compares sham stimulation with low frequency neurostimulation|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.021||0.001|TWO_SIDED|95.0|0.029|0.111|||Mixed Models Analysis|||A MMANOVA analysis using an unstructured covariance structure examined the main effect of type of neurostimulation provided.||.111|.029|.001
74036689|NCT04348591|147626781|SUPERIORITY||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.232||0.34|TWO_SIDED|95.0|-0.243|0.689|||Mixed Models Analysis||This is the result for the main effect found of group (emotion dysregulation group versus misophonia)|A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.689|-.243|.34
74036690|NCT04348591|147626781|SUPERIORITY||Mean Difference (Final Values)|0.493|STANDARD_ERROR_OF_MEAN|0.148||0.001|TWO_SIDED|95.0|0.198|0.787|||Mixed Models Analysis|This is the main effect of neurostimulation condition. Specifically here we show the difference in estimated marginal means between sham and HF-rTMS||A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.787|.198|.001
74036691|NCT04348591|147626781|SUPERIORITY||Mean Difference (Final Values)|0.469|STANDARD_ERROR_OF_MEAN|0.144||0.002|TWO_SIDED|95.0|0.182|0.757|||Mixed Models Analysis|This is the main effect of neurostimulation administered, specifically comparing estimated marginal means for sham and LF-rTMS||A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.757|.182|.002
74036692|NCT04348591|147626781|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.0005|TWO_SIDED||||||Mixed Models Analysis||mean difference between sham and HF-rTMS for misophonia participants only when downregulating misophonic sounds|The investigators tested the interaction between experimental neurostimulation (sham, active high frequency rTMS, active low frequency rTMS), instruction provided (listen to neutral sound; listen to aversive sound, listen to misophonic sound, downregulate aversive sound, downregulate misophonic sound), and group (misophonic, clinical control) as part of the same MMANOVA analysis described above (i.e., controlling for coil-to-cortex distance, racial background, baseline, \& presence of headache).||||.0005
74036693|NCT04348591|147626783|SUPERIORITY||Mean Difference (Final Values)|0.0563|STANDARD_ERROR_OF_MEAN|0.09853||0.57|TWO_SIDED|95.0|-0.14149|0.25411|||t-test, 2 sided|||An independent samples t-test was conducted to examine differences between groups in BOLD bilateral dlPFC signal during the regulation of misophonic versus aversive sounds. One outlier was removed from the misophonia group to avoid violating the normality assumption.||.25411|-.14149|.57
74036694|NCT04348591|147626784|SUPERIORITY||Mean Difference (Final Values)|0.037293|STANDARD_ERROR_OF_MEAN|0.131419||0.778|TWO_SIDED|95.0|-0.22667|0.301257|||t-test, 2 sided|50 degrees of freedom||An independent samples t-test was conducted to examine differences between groups in vmPFC activation that was greater when downregulating misophonic versus non-misophonic distress. One participant from each group was excluded for being an outlier||0.301257|-0.226670|.778
74036695|NCT04348591|147626785|SUPERIORITY||z score|4.69|||<|0.05|TWO_SIDED||||||mixed effects whole-brain using cluster|||Mixed effects (FSL's FLAME 1; Oxford Univ., UK) whole brain analyses using cluster correction following a voxel-wise Z-score threshold of 2.3.||||<.05
74036696|NCT04348591|147626786|SUPERIORITY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.283||0.49|TWO_SIDED|95.0|-0.766|0.372|||Mixed Models Analysis|This is the main effect from the MMANOVA analysis for group difference.||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||.372|-.766|.49
74036697|NCT04348591|147626786|SUPERIORITY||Mean Difference (Final Values)|0.909|STANDARD_ERROR_OF_MEAN|0.147|<|1e-07|TWO_SIDED|95.0|0.62|1.97||This p-value corresponds to the difference between sham and HF-rTMS stimulation|Mixed Models Analysis|||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the main effect of neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||1.97|.62|<.0000001
74036698|NCT04348591|147626786|SUPERIORITY||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.139||0.018|TWO_SIDED|95.0|0.057|0.605||The test corresponds to the difference between sham and LF-rTMS|Mixed Models Analysis|||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the main effect of neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||.605|.057|.018
74036699|NCT04348591|147626786|SUPERIORITY||Mean Difference (Final Values)|1.02|||<|1e-06|TWO_SIDED||||||Mixed Models Analysis||For participants with misophonia difference in distress produced by a misophonic sound when downregulating misophonic sounds while receiving sham vs.HF-rTMS|The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the interaction effect of group by neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||||<.000001
73877148|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-32.4|45.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||45.7|-32.4|1.000
73877149|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||18.2|-28.2|1.000
73877150|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-2.2||||1|TWO_SIDED|95.0|-29.0|24.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||24.6|-29.0|1.000
73877151|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.1|-37.1|1.000
73877152|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-11.4||||0.7|TWO_SIDED|95.0|-45.7|22.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||22.8|-45.7|0.700
73877153|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-40.0||||0.058|TWO_SIDED|95.0|-64.8|-15.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||-15.2|-64.8|0.058
73999795|NCT05172050|147548217|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Odds Ratio (OR)|5.414||||0.0673|TWO_SIDED|95.0|0.858||The upper limit is not estimable (NE), due to the low number of events||Regression, Logistic||||||0.858|0.0673
73999796|NCT05172050|147548217|SUPERIORITY||Odds Ratio (OR)|12.186||||0.0061|TWO_SIDED|95.0|2.147||The upper limit was not estimable due to the low number of events|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm.|||2.147|0.0061
73999797|NCT05172050|147548217|SUPERIORITY||Odds Ratio (OR)|5.936||||0.0567|TWO_SIDED|95.0|0.938||The upper limit was not estimable due to the low number of events|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm|||0.938|0.0567
73999798|NCT05172050|147548218|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects|Odds Ratio (OR)|1.663||||0.7121|TWO_SIDED|95.0|0.337|9.053|||Regression, Logistic|||||9.053|0.337|0.7121
73999799|NCT05172050|147548218|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects|Odds Ratio (OR)|0.963|||>|0.999|TWO_SIDED|95.0|0.185|4.977|||Regression, Logistic|||||4.977|0.185|>0.999
73877154|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||69.2|-22.5|0.354
73877155|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|16.2||||0.45|TWO_SIDED|95.0|-18.1|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||50.4|-18.1|0.450
73877156|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-39.1|35.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||35.8|-39.1|1.000
73999800|NCT05172050|147548218|SUPERIORITY||Odds Ratio (OR)|2.34||||0.5378|TWO_SIDED|95.0|0.35|20.153||Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm||20.153|0.350|0.5378
73999801|NCT05172050|147548218|SUPERIORITY||Odds Ratio (OR)|1.209|||>|0.999|TWO_SIDED|95.0|0.185|8.589||Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm||8.589|0.185|>0.999
73999802|NCT05172050|147548219|SUPERIORITY||Odds Ratio (OR)|1.114|||>|0.999|TWO_SIDED|95.0|0.219|5.708|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 14||5.708|0.219|>0.999
73999803|NCT05172050|147548219|SUPERIORITY||Odds Ratio (OR)|3.202||||0.2553|TWO_SIDED|95.0|0.541|22.116|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||At day 14||22.116|0.541|0.2553
73999804|NCT05172050|147548219|SUPERIORITY||Odds Ratio (OR)|2.16||||0.6189|TWO_SIDED|95.0|0.294|18.532|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 28||18.532|0.294|0.6189
73877157|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||69.2|-22.5|0.354
73999805|NCT05172050|147548219|SUPERIORITY||Odds Ratio (OR)|7.22||||0.1662|TWO_SIDED|95.0|0.586|413.499|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 28||413.499|0.586|0.1662
73999806|NCT05172050|147548220|SUPERIORITY||Odds Ratio (OR)|0.972|||>|0.999|TWO_SIDED|95.0|0.193|4.906|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 7||4.906|0.193|>0.999
73999807|NCT05172050|147548220|SUPERIORITY||Odds Ratio (OR)|1.156|||>|0.999|TWO_SIDED|95.0|0.2|6.822|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 7||6.822|0.200|>0.999
73999808|NCT05172050|147548220|SUPERIORITY||Odds Ratio (OR)|1.066|||>|0.999|TWO_SIDED|95.0|0.208|5.478|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 28||5.478|0.208|>0.999
73999809|NCT05172050|147548220|SUPERIORITY||Odds Ratio (OR)|2.068||||0.5465|TWO_SIDED|95.0|0.369|12.58|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 28||12.580|0.369|0.5465
73999810|NCT05172050|147548223|SUPERIORITY|||||||0.3899||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 7 R60 vs Placebo||||0.3899
73999811|NCT05172050|147548223|SUPERIORITY|||||||0.4075||||||P-Value comparing % among treatment groups Raloxifene 120 mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 7 R120 vs placebo||||0.4075
73999812|NCT05172050|147548223|SUPERIORITY|||||||0.3899||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 14 R60 vs placebo||||0.3899
73999813|NCT05172050|147548223|SUPERIORITY|||||||0.4075|||||||Fisher Exact|P-Value comparing % among treatment groups Raloxifene 120mg versus Placebo using Fisher's Exact test.||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 14 R120 vs placebo||||0.4075
73999814|NCT05172050|147548223|SUPERIORITY|||||||0.6846||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 28 R60 vs placebo||||0.6846
73999815|NCT05172050|147548223|SUPERIORITY|||||||0.6614||||||P-Value comparing % among treatment groups Raloxifene 120mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 28 R120 vs placebo||||0.6614
73999816|NCT05172050|147548225|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||Log Rank|||||1.00|1.00|
73999817|NCT05172050|147548225|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|1.0|1.0||p value= not estimable|Log Rank|||||1.00|1.00|
73999818|NCT01846494|147548229|OTHER|||||||0.6173|||||||Log Rank|||||||0.6173
73999819|NCT05180500|147548230|OTHER|||||||0.7|||||||Fisher Exact|||||||.70
74036700|NCT04348591|147626787|SUPERIORITY||Mean Difference (Final Values)|9.53|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|||||This is the result corresponding to the main effect of time in the repeated measures ANCOVA|ANCOVA|||Repeated measures ANOVA (controlling for racial background)||||<.001
74036701|NCT04348591|147626787|SUPERIORITY||||||>|0.012|||||||ANCOVA|This analysis corresponds to the main effect of group.||Repeated measures ANOVA (controlling for racial background)||||>.012
73999820|NCT05180500|147548231|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
73999821|NCT05180500|147548234|OTHER|||||||0.28|||||||Fisher Exact|||||||0.28
73999822|NCT05180500|147548235|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
73999823|NCT05180500|147548236|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
73999824|NCT05180500|147548237|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
73999825|NCT05180500|147548238|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
73999826|NCT05180500|147548239|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73999827|NCT04617275|147548246|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.5863|TWO_SIDED|90.0|-15.23|19.85||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||19.85|-15.23|0.5863
74036702|NCT04348591|147626788|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Anxiety subscale||||.78
73999828|NCT04617275|147548246|SUPERIORITY||Mean Difference (Final Values)|-17.41||||0.0494|TWO_SIDED|90.0|-34.75|-0.06||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.06|-34.75|0.0494
73999829|NCT04617275|147548246|SUPERIORITY||Mean Difference (Final Values)|-30.85||||0.0019|TWO_SIDED|90.0|-48.09|-13.61||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-13.61|-48.09|0.0019
74036703|NCT04348591|147626788|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Depression subscale||||.29
74036704|NCT04348591|147626788|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Fatigue subscale||||.64
74090660|NCT02040779|147735344|SUPERIORITY||LSM difference|-0.358||||0.0285|TWO_SIDED|95.0|-0.678|-0.038||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.038|-0.678|0.0285
73999830|NCT04617275|147548246|SUPERIORITY||Mean Difference (Final Values)|-33.66||||0.0009|TWO_SIDED|90.0|-51.0|-16.32||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-16.32|-51.00|0.0009
73999831|NCT04617275|147548246|SUPERIORITY||Mean Difference (Final Values)|-19.52||||0.0343|TWO_SIDED|90.0|-37.12|-1.92||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.92|-37.12|0.0343
73999832|NCT04617275|147548247|SUPERIORITY||Mean Difference (Final Values)|-3.33||||0.3804|TWO_SIDED|90.0|-21.41|14.76||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||14.76|-21.41|0.3804
73999833|NCT04617275|147548247|SUPERIORITY||Mean Difference (Final Values)|-19.65||||0.0348|TWO_SIDED|90.0|-37.44|-1.87||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.87|-37.44|0.0348
73999834|NCT04617275|147548247|SUPERIORITY||Mean Difference (Final Values)|-32.8||||0.0014|TWO_SIDED|90.0|-50.54|-15.05||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-15.05|-50.54|0.0014
73999835|NCT04617275|147548247|SUPERIORITY||Mean Difference (Final Values)|-35.85||||0.0007|TWO_SIDED|90.0|-53.9|-17.81||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-17.81|-53.90|0.0007
73999836|NCT04617275|147548247|SUPERIORITY||Mean Difference (Final Values)|-28.49||||0.0052|TWO_SIDED|90.0|-46.6|-10.37||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-10.37|-46.60|0.0052
73999837|NCT04617275|147548248|SUPERIORITY||Mean Difference (Final Values)|-25.58||||0.025|TWO_SIDED|90.0|-46.97|-4.18||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.18|-46.97|0.0250
73999838|NCT04617275|147548248|SUPERIORITY||Mean Difference (Final Values)|-32.95||||0.0053|TWO_SIDED|90.0|-53.95|-11.95||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-11.95|-53.95|0.0053
73999839|NCT04617275|147548248|SUPERIORITY||Mean Difference (Final Values)|-40.07||||0.0012|TWO_SIDED|90.0|-61.41|-18.73|||Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-18.73|-61.41|0.0012
73999840|NCT04617275|147548248|SUPERIORITY||Mean Difference (Final Values)|-45.47||||0.0003|TWO_SIDED|90.0|-66.85|-24.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-24.10|-66.85|0.0003
74036705|NCT04348591|147626788|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Sleep disturbance subscale||||.16
74036706|NCT04348591|147626788|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Ability to partake in social roles subscale||||.56
74036707|NCT02104804|147626803|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.72|-0.45|||ANCOVA|||||-0.45|-0.72|<0.001
74036708|NCT02104804|147626804|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6133.2|STANDARD_ERROR_OF_MEAN|781.06|<|0.001|TWO_SIDED|95.0|-7668.5|-4597.9|||ANCOVA|||||-4597.9|-7668.5|<0.001
74036709|NCT02104804|147626805|SUPERIORITY_OR_OTHER||Difference in Least squares mean|-39.11|STANDARD_ERROR_OF_MEAN|5.24|<|0.001|TWO_SIDED|95.0|-49.41|-28.82|||ANCOVA|||||-28.82|-49.41|<0.001
73999841|NCT04617275|147548248|SUPERIORITY||Mean Difference (Final Values)|-33.63||||0.0055|TWO_SIDED|90.0|-55.19|-12.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-12.08|-55.19|0.0055
74036710|NCT02104804|147626806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8||||0.002|TWO_SIDED|95.0|3.1|12.6|||Difference in proportions|||||12.6|3.1|0.002
74036711|NCT02104804|147626807|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-15.88|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-21.53|-10.22|||ANCOVA|||||-10.22|-21.53|<0.001
74036712|NCT02104804|147626808|SUPERIORITY_OR_OTHER||Difference in Least squares mean|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.43|TWO_SIDED|95.0|-0.44|0.19|||ANCOVA|||||0.19|-0.44|0.430
74036713|NCT02720016|147626810|SUPERIORITY||Slope|-3.216|STANDARD_ERROR_OF_MEAN|1.3||0.016|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.016
74036714|NCT02720016|147626810|SUPERIORITY||Slope|-4.11|STANDARD_ERROR_OF_MEAN|1.308||0.002|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.002
74036715|NCT02720016|147626810|SUPERIORITY||Slope|-0.894|STANDARD_ERROR_OF_MEAN|1.296||0.492|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.492
74036716|NCT02720016|147626815|SUPERIORITY||Slope|-0.352|STANDARD_ERROR_OF_MEAN|2.172||0.872|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.872
73999842|NCT04617275|147548249|SUPERIORITY||Mean Difference (Final Values)|-27.79||||0.0127|TWO_SIDED|90.0|-48.12|-7.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-7.47|-48.12|0.0127
73999843|NCT04617275|147548249|SUPERIORITY||Mean Difference (Final Values)|-25.67||||0.0171|TWO_SIDED|90.0|-45.51|-5.83||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-5.83|-45.51|0.0171
73999844|NCT04617275|147548249|SUPERIORITY||Mean Difference (Final Values)|-46.94||||0.0001|TWO_SIDED|90.0|-67.16|-26.72||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-26.72|-67.16|0.0001
73999845|NCT04617275|147548249|SUPERIORITY||Mean Difference (Final Values)|-33.79||||0.0037|TWO_SIDED|90.0|-54.32|-13.27||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-13.27|-54.32|0.0037
74036717|NCT02720016|147626815|SUPERIORITY||Slope|-0.931|STANDARD_ERROR_OF_MEAN|2.296||0.686|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.686
73999846|NCT04617275|147548249|SUPERIORITY||Mean Difference (Final Values)|-42.13||||0.0005|TWO_SIDED|90.0|-62.85|-21.4||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-21.40|-62.85|0.0005
74036718|NCT02720016|147626815|SUPERIORITY||Slope|-0.579|STANDARD_ERROR_OF_MEAN|2.256||0.798|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.798
73999847|NCT04617275|147548250|SUPERIORITY||Mean Difference (Final Values)|-12.85||||0.1678|TWO_SIDED|90.0|-34.9|9.21||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||9.21|-34.90|0.1678
73999848|NCT04617275|147548250|SUPERIORITY||Mean Difference (Final Values)|-14.82||||0.1223|TWO_SIDED|90.0|-35.85|6.21||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||6.21|-35.85|0.1223
73999849|NCT04617275|147548250|SUPERIORITY||Mean Difference (Final Values)|-33.97||||0.0054|TWO_SIDED|90.0|-55.66|-12.28||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-12.28|-55.66|0.0054
73999850|NCT04617275|147548250|SUPERIORITY||Mean Difference (Final Values)|1.31||||0.5398|TWO_SIDED|90.0|-20.38|22.99||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||22.99|-20.38|0.5398
73999851|NCT04617275|147548250|SUPERIORITY||Mean Difference (Final Values)|-14.42||||0.1409|TWO_SIDED|90.0|-36.56|7.72||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||7.72|-36.56|0.1409
73999852|NCT04617275|147548251|SUPERIORITY||Mean Difference (Final Values)|-28.65||||0.0236|TWO_SIDED|90.0|-52.31|-4.99||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.99|-52.31|0.0236
74036719|NCT02720016|147626820|SUPERIORITY||Slope|-1.213|STANDARD_ERROR_OF_MEAN|2.518||0.631|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.631
74036720|NCT02720016|147626820|SUPERIORITY||Slope|-1.461|STANDARD_ERROR_OF_MEAN|2.495||0.56|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.560
74036721|NCT02720016|147626820|SUPERIORITY||Slope|-0.248|STANDARD_ERROR_OF_MEAN|2.536||0.922|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.922
73877158|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|9.0||||0.7|TWO_SIDED|95.0|-24.6|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||42.7|-24.6|0.700
73877159|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-14.2||||0.621|TWO_SIDED|95.0|-46.2|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||17.9|-46.2|0.621
73877160|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-51.8|38.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||38.5|-51.8|1.000
73877161|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-4.3||||0.812|TWO_SIDED|95.0|-39.6|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||31.0|-39.6|0.812
73999853|NCT04617275|147548251|SUPERIORITY||Mean Difference (Final Values)|-27.32||||0.0226|TWO_SIDED|90.0|-49.67|-4.97||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.97|-49.67|0.0226
73999854|NCT04617275|147548251|SUPERIORITY||Mean Difference (Final Values)|-40.85||||0.0022|TWO_SIDED|90.0|-64.11|-17.59||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-17.59|-64.11|0.0022
73999855|NCT04617275|147548251|SUPERIORITY||Mean Difference (Final Values)|-10.25||||0.2335|TWO_SIDED|90.0|-33.59|13.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||13.08|-33.59|0.2335
73999856|NCT04617275|147548251|SUPERIORITY||Mean Difference (Final Values)|-24.38||||0.0494|TWO_SIDED|90.0|-48.69|-0.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.08|-48.69|0.0494
73999857|NCT04617275|147548252|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.2485|TWO_SIDED|90.0|-0.31|0.13||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.13|-0.31|0.2485
74036722|NCT04501679|147626850|SUPERIORITY||Strata-adjusted percentage difference|37.4|||<|0.0001|TWO_SIDED|95.0|26.3|48.5||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||48.5|26.3|<0.0001
73999858|NCT04617275|147548252|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.0252|TWO_SIDED|90.0|-0.48|-0.04||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.04|-0.48|0.0252
73999859|NCT04617275|147548252|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0053|TWO_SIDED|90.0|-0.56|-0.12||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.12|-0.56|0.0053
73999860|NCT04617275|147548252|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.009|TWO_SIDED|90.0|-0.54|-0.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.10|-0.54|0.0090
73999861|NCT04617275|147548252|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.1066|TWO_SIDED|90.0|-0.39|0.05||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.05|-0.39|0.1066
73877162|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-15.0||||0.657|TWO_SIDED|95.0|-53.9|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.9|-53.9|0.657
73999862|NCT04617275|147548253|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.274|TWO_SIDED|90.0|-0.4|0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.19|-0.40|0.2740
73999863|NCT04617275|147548253|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0196|TWO_SIDED|90.0|-0.66|-0.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.08|-0.66|0.0196
73999864|NCT04617275|147548253|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.0006|TWO_SIDED|90.0|-0.88|-0.3|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.30|-0.88|0.0006
73999865|NCT04617275|147548253|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.0019|TWO_SIDED|90.0|-0.82|-0.23||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.23|-0.82|0.0019
73999866|NCT04617275|147548253|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0243|TWO_SIDED|90.0|-0.66|-0.06||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.06|-0.66|0.0243
73999867|NCT04617275|147548254|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.1587|TWO_SIDED|90.0|-0.62|0.15||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.15|-0.62|0.1587
73999868|NCT04617275|147548254|SUPERIORITY||Mean Difference (Final Values)|-0.66||||0.0027|TWO_SIDED|90.0|-1.04|-0.27||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.27|-1.04|0.0027
73877163|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||69.2|-22.5|0.354
73877164|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|16.2||||0.45|TWO_SIDED|95.0|-18.1|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||50.4|-18.1|0.450
73877165|NCT02365649|147294857|SUPERIORITY||Risk Difference (RD)|-14.2||||0.621|TWO_SIDED|95.0|-46.2|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||17.9|-46.2|0.621
73877166|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20%of the cells have expected cell count \<5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||95.6|-62.2|1.000
73877167|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||79.6|-21.3|0.592
73999869|NCT04617275|147548254|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.0002|TWO_SIDED|90.0|-1.24|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-1.24|0.0002
73999870|NCT04617275|147548254|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.0016|TWO_SIDED|90.0|-1.1|-0.32||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.32|-1.10|0.0016
73999871|NCT04617275|147548254|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.0027|TWO_SIDED|90.0|-1.07|-0.28||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.28|-1.07|0.0027
73999872|NCT04617275|147548255|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.0472|TWO_SIDED|90.0|-0.86|-0.01||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.01|-0.86|0.0472
73999873|NCT04617275|147548255|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.0004|TWO_SIDED|90.0|-1.29|-0.45||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.45|-1.29|0.0004
73999874|NCT04617275|147548255|SUPERIORITY||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|90.0|-1.53|-0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.68|-1.53|<0.0001
74039820|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0212|TWO_SIDED|95.0|-0.49|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.49|0.0212
73999875|NCT04617275|147548255|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.0003|TWO_SIDED|90.0|-1.36|-0.5||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.50|-1.36|0.0003
73999876|NCT04617275|147548255|SUPERIORITY||Mean Difference (Final Values)|-0.91||||0.0004|TWO_SIDED|90.0|-1.34|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-1.34|0.0004
73999877|NCT04617275|147548256|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.0116|TWO_SIDED|90.0|-1.18|-0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.19|-1.18|0.0116
73999878|NCT04617275|147548256|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.0008|TWO_SIDED|90.0|-1.43|-0.46|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.46|-1.43|0.0008
73999879|NCT04617275|147548256|SUPERIORITY||Mean Difference (Final Values)|-1.16|||<|0.0001|TWO_SIDED|90.0|-1.66|-0.67||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.67|-1.66|<0.0001
73877168|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-64.8|38.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||38.2|-64.8|1.000
73877169|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-80.0|80.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||80.0|-80.0|1.000
73999880|NCT04617275|147548256|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0017|TWO_SIDED|90.0|-1.4|-0.4||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.40|-1.40|0.0017
73999881|NCT04617275|147548256|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.0004|TWO_SIDED|90.0|-1.55|-0.55||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.55|-1.55|0.0004
73999882|NCT04617275|147548257|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.0132|TWO_SIDED|90.0|-1.32|-0.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.20|-1.32|0.0132
73999883|NCT04617275|147548257|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.0014|TWO_SIDED|90.0|-1.55|-0.46||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.46|-1.55|0.0014
73999884|NCT04617275|147548257|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0002|TWO_SIDED|90.0|-1.8|-0.69||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.69|-1.80|0.0002
73999885|NCT04617275|147548257|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.0174|TWO_SIDED|90.0|-1.29|-0.16|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.16|-1.29|0.0174
73877170|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-39.7|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||64.7|-39.7|1.000
73999886|NCT04617275|147548257|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0002|TWO_SIDED|90.0|-1.82|-0.69||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.69|-1.82|0.0002
73999887|NCT04617275|147548258|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.2843|TWO_SIDED|90.0|-1.02|0.5||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.50|-1.02|0.2843
73999888|NCT04617275|147548258|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.431|TWO_SIDED|90.0|-0.84|0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.68|-0.84|0.4310
73999889|NCT04617275|147548258|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.2402|TWO_SIDED|90.0|-1.07|0.43||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.43|-1.07|0.2402
73999890|NCT04617275|147548258|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.1397|TWO_SIDED|90.0|-1.24|0.26||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.26|-1.24|0.1397
73999891|NCT04617275|147548258|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.4393|TWO_SIDED|90.0|-0.85|0.71||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.71|-0.85|0.4393
73999892|NCT04617275|147548259|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.1491|TWO_SIDED|90.0|-2.0|0.45||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.45|-2.00|0.1491
73999893|NCT04617275|147548259|SUPERIORITY||Median Difference (Final Values)|0.12||||0.5664|TWO_SIDED|90.0|-1.09|1.34||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.34|-1.09|0.5664
73999894|NCT04617275|147548259|SUPERIORITY||Median Difference (Final Values)|-1.12||||0.0632|TWO_SIDED|90.0|-2.33|0.09||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.09|-2.33|0.0632
73999895|NCT04617275|147548259|SUPERIORITY||Median Difference (Final Values)|-1.01||||0.0847|TWO_SIDED|90.0|-2.23|0.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.20|-2.23|0.0847
73999896|NCT04617275|147548259|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5264|TWO_SIDED|90.0|-1.2|1.3||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.30|-1.20|0.5264
73999897|NCT04617275|147548260|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.0395|TWO_SIDED|90.0|-2.86|-0.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.10|-2.86|0.0395
73999898|NCT04617275|147548260|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.3726|TWO_SIDED|90.0|-1.63|1.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.10|-1.63|0.3726
73999899|NCT04617275|147548260|SUPERIORITY||Mean Difference (Final Values)|-2.36||||0.0028|TWO_SIDED|90.0|-3.74|-0.98||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.98|-3.74|0.0028
73999900|NCT04617275|147548260|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.0139|TWO_SIDED|90.0|-3.23|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-3.23|0.0139
73999901|NCT04617275|147548260|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.1815|TWO_SIDED|90.0|-2.19|0.64||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.64|-2.19|0.1815
73999902|NCT04617275|147548261|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.0112|TWO_SIDED|90.0|-3.71|-0.61||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.61|-3.71|0.0112
73999903|NCT04617275|147548261|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.2161|TWO_SIDED|90.0|-2.24|0.8||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.80|-2.24|0.2161
73999904|NCT04617275|147548261|SUPERIORITY||Mean Difference (Final Values)|-3.47||||0.0002|TWO_SIDED|90.0|-5.02|-1.92||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.92|-5.02|0.0002
73999905|NCT04617275|147548261|SUPERIORITY||Mean Difference (Final Values)|-2.05||||0.0147|TWO_SIDED|90.0|-3.59|-0.51||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.51|-3.59|0.0147
73999906|NCT04617275|147548261|SUPERIORITY||Mean Difference (Final Values)|-2.97||||0.0013|TWO_SIDED|90.0|-4.56|-1.37||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.37|-4.56|0.0013
73999907|NCT04617275|147548262|SUPERIORITY||Mean Difference (Final Values)|-2.46||||0.0111|TWO_SIDED|90.0|-4.22|-0.7||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.70|-4.22|0.0111
73999908|NCT04617275|147548262|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.16|TWO_SIDED|90.0|-2.75|0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.68|-2.75|0.1600
73999909|NCT04617275|147548262|SUPERIORITY||Mean Difference (Final Values)|-4.27|||<|0.0001|TWO_SIDED|90.0|-6.03|-2.52||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.52|-6.03|<0.0001
73999910|NCT04617275|147548262|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0061|TWO_SIDED|90.0|-4.42|-0.94||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.94|-4.42|0.0061
73999911|NCT04617275|147548262|SUPERIORITY||Mean Difference (Final Values)|-3.71||||0.0005|TWO_SIDED|90.0|-5.52|-1.89||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.89|-5.52|0.0005
73877171|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-30.0||||0.545|TWO_SIDED|95.0|-83.2|23.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||23.2|-83.2|0.545
73999912|NCT04617275|147548263|SUPERIORITY||Mean Difference (Final Values)|-3.21||||0.0047|TWO_SIDED|90.0|-5.22|-1.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.20|-5.22|0.0047
73999913|NCT04617275|147548263|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.1003|TWO_SIDED|90.0|-3.45|0.44||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.44|-3.45|0.1003
73999914|NCT04617275|147548263|SUPERIORITY||Mean Difference (Final Values)|-4.95|||<|0.0001|TWO_SIDED|90.0|-6.96|-2.95||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.95|-6.96|<0.0001
73999915|NCT04617275|147548263|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0197|TWO_SIDED|90.0|-4.49|-0.51||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.51|-4.49|0.0197
73999916|NCT04617275|147548263|SUPERIORITY||Mean Difference (Final Values)|-4.94|||<|0.0001|TWO_SIDED|90.0|-7.03|-2.85||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.85|-7.03|<0.0001
73999917|NCT04617275|147548264|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.0836|TWO_SIDED|90.0|-2.12|0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.19|-2.12|0.0836
73999918|NCT04617275|147548265|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.0386|TWO_SIDED|90.0|-3.07|-0.12||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.12|-3.07|0.0386
73999919|NCT04617275|147548266|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.1566|TWO_SIDED|90.0|-3.99|1.0||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.00|-3.99|0.1566
73999920|NCT04617275|147548267|SUPERIORITY||Mean Difference (Final Values)|-2.62||||0.0916|TWO_SIDED|90.0|-5.91|0.67||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.67|-5.91|0.0916
73999921|NCT04617275|147548268|SUPERIORITY||Mean Difference (Final Values)|-3.07||||0.059|TWO_SIDED|90.0|-6.31|0.17||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.17|-6.31|0.0590
73999922|NCT04617275|147548269|SUPERIORITY||Mean Difference (Final Values)|-3.74||||0.0826|TWO_SIDED|90.0|-8.23|0.75||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.75|-8.23|0.0826
73999923|NCT02317432|147548281|SUPERIORITY||Slope|-0.12|||<|0.01|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||<0.01
73999924|NCT02317432|147548282|SUPERIORITY||Slope|0.6||||0.03|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.03
73999925|NCT02317432|147548283|SUPERIORITY||Slope|6.0||||0.02|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.02
73999926|NCT02317432|147548284|SUPERIORITY||Slope|-1.24||||0.15|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.15
74036723|NCT04501679|147626851|SUPERIORITY||Strata-adjusted percentage difference|28.5|||<|0.0001|TWO_SIDED|95.0|18.8|38.2||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.2|18.8|<0.0001
74039821|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.15||0.0003|TWO_SIDED|95.0|-0.81|-0.24|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.81|0.0003
73999927|NCT02317432|147548285|SUPERIORITY||Slope|-0.49||||0.35|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.35
73999928|NCT05593445|147548286|SUPERIORITY||Odds Ratio (OR)|0.83||||0.737|TWO_SIDED|95.0|0.29|2.41|||Chi-squared|||||2.41|0.29|0.737
73999929|NCT05593445|147548286|SUPERIORITY||response rate difference|-4.3|STANDARD_ERROR_OF_MEAN|12.73|||TWO_SIDED|95.0|-29.2|20.7|||||The 95% confidence interval for the response rate difference was constructed from approximately normal distribution.|||20.7|-29.2|
73999930|NCT05593445|147548287|SUPERIORITY||least squares mean difference|-2.76|STANDARD_ERROR_OF_MEAN|1.14||0.0188|TWO_SIDED|95.0|-5.05|-0.47|||Mixed Model Repeated Measures (MMRM)|||||-0.47|-5.05|0.0188
73999931|NCT05593445|147548288|SUPERIORITY||least squares mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.72||0.4674|TWO_SIDED|95.0|-1.96|0.91|||MMRM|||||0.91|-1.96|0.4674
73999932|NCT05593445|147548289|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9072|TWO_SIDED|95.0|0.503|1.869|||Log Rank||Cox regression model was conducted to compare the difference in hazard rate.|||1.869|0.503|0.9072
73999933|NCT05559476|147548301|NON_INFERIORITY|The non-inferiority is demonstrated if the Upper Limit (UL) of the 2-sided 95% Confidence Interval (CI) of the GMT ratio (Control group divided by Co-Ad group) for RSVPreF3 OA vaccine is less than or equal (\<=)1.5.|GMT Ratio|1.18|||||TWO_SIDED|95.0|1.03|1.35|||||The comparison is done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-A neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.35|1.03|
74008633|NCT04223791|147567317|NON_INFERIORITY|Non-inferiority is concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI for the difference in the percentage of participants with HIV-1 RNA ≥50 copies/mL (DOR/ISL-BIC/FTC/TAF) is less than 4 percentage points.|Estimated difference|0.31|||<|0.001|TWO_SIDED|95.0|-1.19|1.96||p-value for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.|Unstratified Miettinen and Nurminen||Treatment difference for DOR/ISL group-BIC/FTC/TAF group.|||1.96|-1.19|<.001
73877172|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|50.0||||0.464|TWO_SIDED|95.0|10.0|90.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||90.0|10.0|0.464
73877173|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-39.7|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||64.7|-39.7|1.000
73877174|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-50.0||||0.182|TWO_SIDED|95.0|-90.0|-10.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||-10.0|-90.0|0.182
73999934|NCT05559476|147548302|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Darwin/6/2021 H3N2 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.16|0.85|
73999935|NCT05559476|147548302|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.09|0.80|
73999936|NCT05559476|147548302|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.88|1.03|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.03|0.88|
73999937|NCT05559476|147548302|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.02|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.02|0.84|
73999938|NCT05559476|147548303|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSVPreF3 OA vaccine is \<=1.5.|GMT Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.15|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-B neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.15|0.89|
73999939|NCT05559476|147548304|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-1.71|||||TWO_SIDED|95.0|-8.15|4.74||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Darwin/6/2021 H3N2 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||4.74|-8.15|
74008634|NCT04223791|147567318|OTHER|Difference between treatment groups|Difference in % (DOR/ISL- BIC/FTC/TAF)|-3.5|||||TWO_SIDED|95.0|-10.4|3.4|||||Based on Miettinen and Nurminen method|||3.4|-10.4|
74008635|NCT04223791|147567319|OTHER|Difference between treatment groups|Difference in % (DOR/ISL- BIC/FTC/TAF)|-0.02|||||TWO_SIDED|95.0|-2.7|2.6|||||Based on Miettinen and Nurminen method|||2.6|-2.7|
74008636|NCT04223791|147567332|SUPERIORITY||Treatment Difference|-0.3||||0.392|TWO_SIDED|95.0|-0.99|0.39|||ANCOVA|Model included terms for baseline weight, sex, race, and treatment.|Treatment difference for DOR/ISL group-BIC/FTC/TAF group.|||0.39|-0.99|0.392
74008637|NCT00395863|147567357|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 1|wilcoxon signed-rank test|||||||< 0.0001
74008638|NCT00395863|147567357|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test|||||||<0.0001
73877175|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||95.6|-62.2|1.000
73999940|NCT05559476|147548304|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-4.11|||||TWO_SIDED|95.0|-10.67|2.48||||||To evaluate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Victoria/2570/2019 H1N1 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||2.48|-10.67|
73999941|NCT05559476|147548304|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-8.56|||||TWO_SIDED|95.0|-14.75|-2.29||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Austria/1359417/2021 Victoria at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||-2.29|-14.75|
73999942|NCT05559476|147548304|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-5.89|||||TWO_SIDED|95.0|-12.28|0.56||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Phuket/3073/2013 Yamagata strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||0.56|-12.28|
73999943|NCT03992846|147548319|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 1.10 or greater from baseline pain for Dysmenorrhea (DYS).|Odds Ratio (OR)|2.56|||<|0.001|TWO_SIDED|97.5|1.46|4.49|||Bonferroni-corrected p-value|||||4.49|1.46|<0.001
73999944|NCT03992846|147548319|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 1.10 or greater from baseline pain for Dysmenorrhea (DYS).|Odds Ratio (OR)|8.8|||<|0.001|TWO_SIDED|97.5|4.86|15.91|||Bonferroni-corrected p-value|||||15.91|4.86|<0.001
73999945|NCT03992846|147548320|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 0.80 or greater from baseline pain for Non-Menstrual Pelvic Pain (NMPP).|Odds Ratio (OR)|1.43||||0.279|TWO_SIDED|97.5|0.83|2.45|||Bonferroni-corrected p-value|||||2.45|0.83|0.279
73999946|NCT03992846|147548320|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 0.80 or greater from baseline pain for Non-Menstrual Pelvic Pain (NMPP).|Odds Ratio (OR)|2.01||||0.007|TWO_SIDED|97.5|1.18|3.42|||Bonferroni-corrected p-value|||||3.42|1.18|0.007
73999947|NCT02233543|147548341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2419|TWO_SIDED|95.0|-1.21|0.32|||Mixed Models Analysis|||||0.32|-1.21|0.2419
73999948|NCT02233543|147548342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.79||||0.2016|TWO_SIDED|95.0|-4.51|20.08|||Mixed Models Analysis|||||20.08|-4.51|0.2016
73999949|NCT03573583|147548368|SUPERIORITY||Mean Difference (Final Values)|2.29||||0.03|TWO_SIDED|95.0|0.22|4.36||No formal adjustment for type I error due to the pilot nature of the study. All significance tests were 2-tailed and an alpha level of 0.05 was required for significance.|ANCOVA|Adjusted for baseline score.||Continuous variables were expressed as mean (SD) and categorical variables were as frequencies and percentages. A 2-sided independent-sample t test was used to compare group differences in change scores. Change scores were calculated as Week 16 measurements minus baseline measurements. Statistical analyses were done by a blinded statistician without knowledge of group membership.||4.36|0.22|0.03
73999950|NCT03573583|147548369|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.009|TWO_SIDED|95.0|0.31|1.77|||ANCOVA|Adjusted for baseline score.||||1.77|0.31|0.009
73999951|NCT03573583|147548370|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.07|TWO_SIDED|95.0|-0.1|2.67|||ANCOVA|Baseline as covariate||||2.67|-0.10|0.07
73999952|NCT03573583|147548371|OTHER|Pearson's correlation coefficients, along with their 95% confidence intervals (CIs)|Pearson's Correlation coefficient|0.19||||0.49|TWO_SIDED|95.0|-0.35|0.64|||Pearson's Correlation coefficient|||||0.64|-0.35|0.49
73999953|NCT01850446|147548378|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectively planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|8.56|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien Procedures for Comparing Samples with Multiple Endpoints.|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (patient diary analysis)||||<0.0001
73999954|NCT01850446|147548378|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectievely planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|7.31|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (physician's examination analysis)||||<0.0001
73999955|NCT01850446|147548379|NON_INFERIORITY|Non-inferiority margin was prespecified as 1.2 degree\*day|Mean Difference (Final Values)|0.44||||0.027|ONE_SIDED|97.5|-0.23||||t-test, 1 sided|||Severity of fever was measured as area under curve (body temperature-time)|||-0.23|0.027
73999956|NCT01850446|147548380|NON_INFERIORITY|Non-inferiority magrin was prespecified as 20% of comparator duration|Mean Difference (Final Values)|0.23||||0.02|ONE_SIDED|97.5||0.63|||t-test, 1 sided|mean survival time estimates obtained from survival analysis were compared by means of t-test with infinite degrees of freedom||||0.63||0.02
74008639|NCT00395863|147567357|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test|||||||< 0.0001
74008640|NCT00395863|147567358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Reader 1|wilcoxon signed-rank test|||||||0.0001
74008641|NCT00395863|147567358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||Reader 2|wilcoxon signed-rank test|||||||0.001
74008642|NCT00395863|147567358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||Reader 3|wilcoxon signed-rank test|||||||0.0002
74008643|NCT00395863|147567359|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Reader 1|wilcoxon signed-rank test|||||||<0.0001
73877176|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||79.6|-21.3|0.592
73999957|NCT01850446|147548381|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day)|Z-value|6.95|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics||||<0.0001
73999958|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.49|||<|0.001|ONE_SIDED|97.5||1.33|||t-test, 1 sided|||Severity of influenza symptoms (day1 morning)||1.33||<0.001
73999959|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.56||||0.013|ONE_SIDED|97.5||2.59|||t-test, 1 sided|||Severity of influenza symptoms (day2 morning)||2.59||0.013
73999960|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.82||||0.084|ONE_SIDED|97.5||2.66|||t-test, 1 sided|||Severity of influenza symptoms (day3 morning)||2.66||0.084
73999961|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.62||||0.22|ONE_SIDED|97.5||2.2|||t-test, 1 sided|||Severity of influenza symptoms (day4 morning)||2.2||0.22
73999962|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27||||0.04|ONE_SIDED|97.5||1.07|||t-test, 1 sided|||Severity of influenza symptoms (day5 morning)||1.07||0.04
73999963|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08||||0.13|ONE_SIDED|97.5||0.98|||t-test, 1 sided|||Severity of influenza symptoms (day6 morning)||0.98||0.13
73999964|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25||||0.135|ONE_SIDED|97.5||0.74|||t-test, 1 sided|||severity of influenza symptoms (day1 morning)||0.74||0.135
73999965|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.64||||0.004|ONE_SIDED|97.5||2.67|||t-test, 1 sided|||Severity of influenza symptoms (day1 evening)||2.67||0.004
73999966|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.9||||0.05|ONE_SIDED|97.5||2.94|||t-test, 1 sided|||Severity of influenza symptoms (day2 evening)||2.94||0.05
73999967|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34||||0.447|ONE_SIDED|97.5||3.08|||t-test, 1 sided|||Severity of influenza symptoms (day3 evening)||3.08||0.447
73999968|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08||||0.042|ONE_SIDED|97.5||1.4|||t-test, 1 sided|||Severity of influenza symptoms (day4 evening)||1.4||0.042
73999969|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.29||||0.313|ONE_SIDED|97.5||1.53|||t-test, 1 sided|||Severity of influenza symptoms (day5 evening)||1.53||0.313
73999970|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27||||0.087|ONE_SIDED|97.5||0.77|||t-test, 1 sided|||Severity of influenza symptoms (day6 evening)||0.77||0.087
73999971|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.43|||<|0.001|ONE_SIDED|97.5||1.41|||t-test, 1 sided|||Severity of influenza symptoms (day1 physician's objective examination)||1.41||<0.001
73999972|NCT01850446|147548382|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34||||0.305|ONE_SIDED|97.5||3.11|||t-test, 1 sided|||Severity of influenza symptoms (day3 physician's objective examination)||3.11||0.305
73999973|NCT01850446|147548383|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.08||||0.02|ONE_SIDED|97.5||0.5|||t-test, 1 sided|||Fever duration||0.5||0.02
73999974|NCT01850446|147548383|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.18|||<|0.001|ONE_SIDED|97.5||0.14|||t-test, 1 sided|||Non-specific symptoms duration||0.14||<0.001
73999975|NCT01850446|147548383|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25|||<|0.001|ONE_SIDED|97.5||0.11|||t-test, 1 sided|||Nasal/ throat/ chest symptoms duration||0.11||<0.001
73999976|NCT01850446|147548384|NON_INFERIORITY|N.I. margin was prespecified as 20% (AUC ratio supposed to be less than 1.2)|AUC ratio|1.04||||0.015|TWO_SIDED|95.0|0.9|1.17||bootstrap (100000 rep) confidence limits were constructed for AUC ratio|one-sample Z-test|AUC ratio was compared with N.I. margin||Severity of influenza was measured as area under curve (symptoms score-time)||1.17|0.9|0.015
73999977|NCT01850446|147548385|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.05||||0.036|ONE_SIDED|97.5||0.19|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day1)||0.19||0.036
73999978|NCT01850446|147548385|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.01||||0.009|ONE_SIDED|97.5||0.15|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day2)||0.15||0.009
73999979|NCT01850446|147548385|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.03|||<|0.001|ONE_SIDED|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day3)||0.13||<0.001
73999980|NCT01850446|147548385|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|ONE_SIDED|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day4)||0.13||<0.001
73999981|NCT01850446|147548385|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|ONE_SIDED|97.5||0.01|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day5)||0.01||<0.001
73999982|NCT01850446|147548386|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.0|||<|0.001|ONE_SIDED|97.5||0.03|||Z test for proportions|||Percentage of Patients Requiring Antibiotics Administration||0.03||<0.001
73999983|NCT01850446|147548387|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.01||||0.014|ONE_SIDED|97.5||0.15|||Z test for proportions|||Proportion difference of Patients With Negative Results (day3)||0.15||0.014
73999984|NCT01850446|147548387|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.08||||0.037|ONE_SIDED|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day5)||0.03||0.037
73999985|NCT01850446|147548387|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.03|||<|0.001|ONE_SIDED|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day7)||0.03||<0.001
73999986|NCT01850446|147548388|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.03|TWO_SIDED|95.0|0.19|3.59||P-value IL2 provided for between-group comparisson of difference from days 3 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-2)||3.59|0.19|0.03
73999987|NCT01850446|147548388|SUPERIORITY||Mean Difference (Final Values)|1.23||||0.19|TWO_SIDED|95.0|-0.64|3.12||P-value IL2 provided for between-group comparisson of difference from day 7 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-2)||3.12|-0.64|0.19
73999988|NCT01850446|147548388|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IFN-γ)||||0.012
74036724|NCT04501679|147626852|SUPERIORITY||Strata-adjusted percentage difference|33.4|||<|0.0001|TWO_SIDED|95.0|24.3|42.4||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||42.4|24.3|<0.0001
74036725|NCT04501679|147626853|SUPERIORITY||Strata-adjusted percentage difference|30.0|||<|0.0001|TWO_SIDED|95.0|21.3|38.6||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.6|21.3|<0.0001
73999989|NCT01850446|147548388|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IFN-γ)||||<0.0001
73999990|NCT01850446|147548388|SUPERIORITY|||||||0.795|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-18)||||0.795
73999991|NCT01850446|147548388|SUPERIORITY|||||||0.992|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-18)||||0.992
73999992|NCT01850446|147548388|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.04|TWO_SIDED|95.0|0.02|0.92|||t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-4)||0.92|0.02|0.04
73999993|NCT01850446|147548388|SUPERIORITY||Median Difference (Final Values)|0.37||||0.08|TWO_SIDED|95.0|-0.04|0.79|||t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-4)||0.79|-0.04|0.08
73999994|NCT01850446|147548388|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-16)||||0.062
73999995|NCT01850446|147548388|SUPERIORITY|||||||0.638|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-16)||||0.638
73999996|NCT01850446|147548389|SUPERIORITY|||||||0.065|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)||||0.065
73999997|NCT01850446|147548389|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)||||0.404
73999998|NCT01850446|147548389|SUPERIORITY|||||||0.204|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-α)||||0.204
73999999|NCT01850446|147548389|SUPERIORITY|||||||0.386|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-α)||||0.386
74000000|NCT01850446|147548389|SUPERIORITY|||||||0.592|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-γ)||||0.592
74000001|NCT01850446|147548389|SUPERIORITY|||||||0.356|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Spontaneous IFN-γ)||||0.356
74000002|NCT01850446|147548389|SUPERIORITY|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-γ)||||0.475
74000003|NCT01850446|147548389|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-γ)||||>0.99
74000004|NCT01850446|147548390|SUPERIORITY|||||||0.364|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (leukocytes)||||0.364
74000005|NCT01850446|147548390|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (leukocytes)||||0.07
74000006|NCT01850446|147548390|SUPERIORITY|||||||0.607|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day1 to day 3 (neutrophils)||||0.607
74000007|NCT01850446|147548390|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (neutrophils)||||0.028
74000008|NCT01850446|147548390|SUPERIORITY|||||||0.759|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (lymphocytes)||||0.759
74000009|NCT01850446|147548390|SUPERIORITY|||||||0.777|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)||||0.777
74000010|NCT01850446|147548390|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (monocytes)||||0.02
74000011|NCT01850446|147548390|SUPERIORITY|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)||||0.343
73877177|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-64.8|38.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||38.2|-64.8|1.000
73877178|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|66.7||||0.429|TWO_SIDED|95.0|28.9|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||100.0|28.9|0.429
74000012|NCT01850446|147548390|SUPERIORITY|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (eosinophils)||||0.575
74000013|NCT01850446|147548390|SUPERIORITY|||||||0.912|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (eosinophils)||||0.912
74000014|NCT01850446|147548390|SUPERIORITY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (basophils)||||0.242
74000015|NCT01850446|147548390|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (basophils)||||0.102
74000016|NCT01850446|147548390|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+)||||0.429
74036726|NCT04501679|147626854|SUPERIORITY||Strata-adjusted percentage difference|31.9|||<|0.0001|TWO_SIDED|95.0|20.7|43.2||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||43.2|20.7|<0.0001
74091720|NCT05472662|147737052|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.4||||0.599|TWO_SIDED|95.0|-1.97|1.16|||ANCOVA|||"Statistical analysis performed on the data at 1 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||1.16|-1.97|0.599
73877179|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||79.6|-21.3|0.592
74000017|NCT01850446|147548390|SUPERIORITY|||||||0.783|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+)||||0.783
74000018|NCT01850446|147548390|SUPERIORITY|||||||0.466|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD4+)||||0.466
74000019|NCT01850446|147548390|SUPERIORITY|||||||0.945|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD4+)||||0.945
74000020|NCT01850446|147548390|SUPERIORITY|||||||0.335|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD8+)||||0.335
74000021|NCT01850446|147548390|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD8+)||||0.66
73877180|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-33.3||||0.455|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||4.4|-71.1|0.455
74000022|NCT01850446|147548390|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD16+CD56+)||||0.01
74000023|NCT01850446|147548390|SUPERIORITY|||||||0.573|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD16+CD56+)||||0.573
74000024|NCT01850446|147548390|SUPERIORITY|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD16+CD56+)||||0.472
74000025|NCT01850446|147548390|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD16+CD56+)||||0.69
74000026|NCT01850446|147548390|SUPERIORITY|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD8+)||||0.727
74000027|NCT01850446|147548390|SUPERIORITY|||||||0.554|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD8+)||||0.554
74000028|NCT01850446|147548390|SUPERIORITY|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD19+CD3-)||||0.837
74000029|NCT01850446|147548390|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD19+CD3-)||||0.967
74000030|NCT01850446|147548390|SUPERIORITY|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD119+)||||0.473
74000031|NCT01850446|147548390|SUPERIORITY|||||||0.736|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD119+)||||0.736
74000032|NCT01850446|147548391|SUPERIORITY|||||||0.282|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of neutrophils)||||0.282
74000033|NCT01850446|147548391|SUPERIORITY|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of neutrophils)||||0.071
74000034|NCT01850446|147548391|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of lymphocytes)||||0.45
74000035|NCT01850446|147548391|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of lymphocytes)||||0.58
74000036|NCT01850446|147548391|SUPERIORITY|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of monocytes)||||0.017
73956897|NCT01362491|147449739|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.49|||<|0.001|TWO_SIDED|95.0|1.83|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen (Motrin IB) - Placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.15|1.83|<0.001
73956898|NCT01362491|147449739|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.943|TWO_SIDED|95.0|-0.52|0.56||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.56|-0.52|0.943
73956899|NCT01362491|147449739|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|4.1|||<|0.001|TWO_SIDED|95.0|3.03|5.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.18|3.03|<0.001
73956900|NCT01362491|147449739|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|4.17|||<|0.001|TWO_SIDED|95.0|3.09|5.24||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen (Motrin IB) - Placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.24|3.09|<0.001
73956901|NCT01362491|147449739|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.06||||0.888|TWO_SIDED|95.0|-0.95|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-0.95|0.888
73956902|NCT01362491|147449740|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|3.67|||<|0.001|TWO_SIDED|95.0|2.71|4.64||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.64|2.71|<0.001
73956903|NCT01362491|147449740|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|3.66|||<|0.001|TWO_SIDED|95.0|2.68|4.63||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.63|2.68|<0.001
73956904|NCT01362491|147449740|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.964|TWO_SIDED|95.0|-0.78|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-0.78|0.964
74000037|NCT01850446|147548391|SUPERIORITY|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of monocytes)||||0.019
74000038|NCT01850446|147548391|SUPERIORITY|||||||0.424|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of eosinophils)||||0.424
74000039|NCT01850446|147548391|SUPERIORITY|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of eosinophils)||||0.666
74000040|NCT01850446|147548391|SUPERIORITY|||||||0.268|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of basophils)||||0.268
74000041|NCT01850446|147548391|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of basophils)||||0.031
74000042|NCT01850446|147548391|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+)||||0.361
74000043|NCT01850446|147548391|SUPERIORITY|||||||0.699|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+)||||0.699
74000044|NCT01850446|147548391|SUPERIORITY|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD4+)||||0.418
74000045|NCT01850446|147548391|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD4+)||||>0.99
74000046|NCT01850446|147548391|SUPERIORITY|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD8+)||||0.172
74000047|NCT01850446|147548391|SUPERIORITY|||||||0.904|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD8+)||||0.904
74000048|NCT01850446|147548391|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD16+CD56+)||||0.148
74000049|NCT01850446|147548391|SUPERIORITY|||||||0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD16+CD56+)||||0.821
74000050|NCT01850446|147548391|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD16+CD56+)||||0.31
74000051|NCT01850446|147548391|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD16+CD56+)||||>0.99
74000052|NCT01850446|147548391|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD8+)||||0.43
74000053|NCT01850446|147548391|SUPERIORITY|||||||0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD8+)||||0.821
74000054|NCT01850446|147548391|SUPERIORITY|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD19+CD3-)||||0.943
74000055|NCT01850446|147548391|SUPERIORITY|||||||0.841|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD19+CD3-)||||0.841
73956905|NCT01362491|147449740|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|6.27|||<|0.001|TWO_SIDED|95.0|4.65|7.89||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.89|4.65|<0.001
73956906|NCT01362491|147449740|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.16||||0.812|TWO_SIDED|95.0|-1.49|1.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.17|-1.49|0.812
73956907|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|12.02||||0.015|TWO_SIDED|95.0|5.27|18.77||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.77|5.27|0.015
73956908|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|4.5||||0.146|TWO_SIDED|95.0|0.13|8.88||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.88|0.13|0.146
73956909|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|7.62||||0.064|TWO_SIDED|95.0|-0.38|15.63||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.63|-0.38|0.064
73956910|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|58.58|||<|0.001|TWO_SIDED|95.0|44.96|72.21||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||72.21|44.96|<0.001
73956911|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|52.31|||<|0.001|TWO_SIDED|95.0|38.2|66.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||66.41|38.20|<0.001
73956912|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|6.4||||0.357|TWO_SIDED|95.0|-7.27|20.07||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.07|-7.27|0.357
74008644|NCT00395863|147567359|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test|||||||<0.0001
74008645|NCT00395863|147567359|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test|||||||<0.0001
74008646|NCT00395863|147567360|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|0.22|<|0.0001||95.0|0.14|0.3||Mean difference of MultiHance minus Magnevist for change from baseline|t-test, 2 sided|||||0.30|0.14|<0.0001
74008647|NCT00395863|147567361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.2|<|0.0001||95.0|0.22|0.38||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||0.38|0.22|<0.0001
74008648|NCT00395863|147567362|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.19|<|0.0001||95.0|0.18|0.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||0.33|0.18|<0.0001
74008649|NCT00395863|147567363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.99|STANDARD_DEVIATION|59.78||0.0062||95.0|20.72|61.26||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||61.26|20.72|0.0062
73877181|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|31.7||||0.191|TWO_SIDED|95.0|-14.0|77.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||77.4|-14.0|0.191
73877182|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-22.1|22.1|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||22.1|-22.1|1.000
73877183|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-8.3||||1|TWO_SIDED|95.0|-24.0|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||7.3|-24.0|1.000
73877184|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|23.3||||0.538|TWO_SIDED|95.0|-24.5|71.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||71.2|-24.5|0.538
74000056|NCT00759915|147548392|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|109.98||||||90.0|100.1|120.8|||ANOVA|log-transformation||||120.8|100.1|
74000057|NCT00759915|147548394|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|100.91||||||90.0|96.96|105.0|||ANOVA|log-transformation||||105.0|96.96|
74000058|NCT00759915|147548395|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|96.5||||||90.0|92.3|100.97|||ANOVA|log-transformation||||100.97|92.3|
73877185|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-29.8|29.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||29.8|-29.8|1.000
73956913|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|46.68|||<|0.001|TWO_SIDED|95.0|30.43|62.93||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||62.93|30.43|<0.001
73956914|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|47.59|||<|0.001|TWO_SIDED|95.0|31.35|63.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.83|31.35|<0.001
73956915|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
73956916|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
73956917|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
73956918|NCT01362491|147449741|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
74000059|NCT03730480|147548396|OTHER|count of number of results within 15% of reference analyzer||||||||||||||||count of number of responses|The number of results that are within 15% of reference analyzer is reported.|||
74008650|NCT00395863|147567364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.95|STANDARD_DEVIATION|48.64||0.0027||95.0|16.57|45.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||45.33|16.57|0.0027
73877186|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-4.2||||1|TWO_SIDED|95.0|-35.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||27.0|-35.3|1.000
73877187|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|11.7||||0.515|TWO_SIDED|95.0|-26.7|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||50.1|-26.7|0.515
73877188|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-22.1|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||22.1|-22.1|1.000
74000060|NCT02480153|147548407|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if the 2-sided 95% CI fell within (-14%, 14%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||TWO_SIDED|95.0|-10.38|4.44||||||||4.44|-10.38|
74000061|NCT02480153|147548407|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if 2-sided 90% CI fell within (-12%, 15%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||TWO_SIDED|90.0|-9.25|3.28||||||||3.28|-9.25|
74000062|NCT01639495|147548468|SUPERIORITY_OR_OTHER||Percentage of subjects|60.6|||||TWO_SIDED|95.0|51.9|68.8|||||The 2-sided 95% confidence intervals are based on exact binomial|||68.8|51.9|
74000063|NCT01639495|147548470|SUPERIORITY_OR_OTHER||Percentage of subjects with primary AEs|17.4|||||TWO_SIDED|95.0|11.6|24.6|||||The 2-sided 95% confidence interval is exact binomial|||24.6|11.6|
74000064|NCT01639495|147548471|SUPERIORITY_OR_OTHER||Percentage of subjects|97.2|||||TWO_SIDED|95.0|95.6|98.2|||||The 2-sided 95% confidence intervals are exact binomial|||98.2|95.6|
74000065|NCT00007345|147548513|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||An exact Cochran-Armitage trend test was used to compare the distributions. In view of the large number of tests performed, we only refer to those with P-values \<0.01 as statistically significant, with those for which 0.01 \<P\< 0.05 considered trends.|Cochran-Armitage trend test|||||||<0.01
73877189|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|4.2||||1|TWO_SIDED|95.0|-23.6|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||31.9|-23.6|1.000
73877190|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|23.3||||0.538|TWO_SIDED|95.0|-24.5|71.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||71.2|-24.5|0.538
74000066|NCT04433585|147548518|SUPERIORITY||Odds Ratio (OR)|1.46||||0.309|TWO_SIDED|95.0|0.7|3.04|||Regression, Logistic|||||3.04|0.70|0.309
74000067|NCT04433585|147548518|SUPERIORITY||Odds Ratio (OR)|0.97||||0.944|TWO_SIDED|95.0|0.47|2.03|||Regression, Logistic|||||2.03|0.47|0.944
74000068|NCT04433585|147548518|SUPERIORITY||Odds Ratio (OR)|0.84||||0.649|TWO_SIDED|95.0|0.4|1.78|||Regression, Logistic|||||1.78|0.40|0.649
74000069|NCT04433585|147548519|SUPERIORITY||Odds Ratio (OR)|1.89||||0.131|TWO_SIDED|95.0|0.83|4.3|||Regression, Logistic|||||4.30|0.83|0.131
74000070|NCT04433585|147548519|SUPERIORITY||Odds Ratio (OR)|1.09||||0.844|TWO_SIDED|95.0|0.47|2.5|||Regression, Logistic|||||2.50|0.47|0.844
74000071|NCT04433585|147548519|SUPERIORITY||Odds Ratio (OR)|0.57||||0.218|TWO_SIDED|95.0|0.24|1.39|||Regression, Logistic|||||1.39|0.24|0.218
74000072|NCT04433585|147548520|SUPERIORITY||Odds Ratio (OR)|0.97||||0.944|TWO_SIDED|95.0|0.47|2.03|||Regression, Logistic|||||2.03|0.47|0.944
74000073|NCT04433585|147548520|SUPERIORITY||Odds Ratio (OR)|1.46||||0.309|TWO_SIDED|95.0|0.7|3.04|||Regression, Logistic|||||3.04|0.70|0.309
74000074|NCT04433585|147548520|SUPERIORITY||Odds Ratio (OR)|0.84||||0.649|TWO_SIDED|95.0|0.4|1.78|||Regression, Logistic|||||1.78|0.40|0.649
74000075|NCT04433585|147548521|SUPERIORITY||Odds Ratio (OR)|1.91||||0.203|TWO_SIDED|95.0|0.71|5.2|||Regression, Logistic|||||5.20|0.71|0.203
74000076|NCT04433585|147548521|SUPERIORITY||Odds Ratio (OR)|1.1||||0.865|TWO_SIDED|95.0|0.38|3.16|||Regression, Logistic|||||3.16|0.38|0.865
74000077|NCT04433585|147548521|SUPERIORITY||Odds Ratio (OR)|1.07||||0.896|TWO_SIDED|95.0|0.38|3.05|||Regression, Logistic|||||3.05|0.38|0.896
74000078|NCT02074553|147548523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|100.5|||||TWO_SIDED|90.0|93.14|108.44|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% confidence interval (CI).||108.44|93.14|
73877191|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-16.7||||0.478|TWO_SIDED|95.0|-37.8|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||4.4|-37.8|0.478
73877192|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-4.2||||1|TWO_SIDED|95.0|-35.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||27.0|-35.3|1.000
73877193|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|11.7||||0.515|TWO_SIDED|95.0|-26.7|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||50.1|-26.7|0.515
73877194|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-17.9|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||34.6|-17.9|1.000
73877195|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|4.2||||1|TWO_SIDED|95.0|-23.6|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||31.9|-23.6|1.000
73877196|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|25.0||||0.344|TWO_SIDED|95.0|-21.9|71.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||71.9|-21.9|0.344
73877197|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|17.9||||0.429|TWO_SIDED|95.0|-17.8|53.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||53.5|-17.8|0.429
73877198|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-10.7||||1|TWO_SIDED|95.0|-46.4|25.0|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||25.0|-46.4|1.000
73877199|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-40.4|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||57.1|-40.4|1.000
73877200|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|8.3||||0.671|TWO_SIDED|95.0|-29.9|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||46.6|-29.9|0.671
73877201|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-13.1||||0.656|TWO_SIDED|95.0|-56.7|30.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||30.5|-56.7|0.656
73956919|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|18.58||||0.002|TWO_SIDED|95.0|10.43|26.73||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.73|10.43|0.002
73956920|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|7.8||||0.055|TWO_SIDED|95.0|2.14|13.46||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.46|2.14|0.055
73956921|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|10.91||||0.033|TWO_SIDED|95.0|0.98|20.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.83|0.98|0.033
73956922|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|62.03|||<|0.001|TWO_SIDED|95.0|48.65|75.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.41|48.65|<0.001
73877202|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|16.7||||0.627|TWO_SIDED|95.0|-31.4|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||64.7|-31.4|0.627
73877203|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|9.5||||0.701|TWO_SIDED|95.0|-27.7|46.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||46.7|-27.7|0.701
73877204|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-19.0||||0.603|TWO_SIDED|95.0|-56.2|18.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||18.1|-56.2|0.603
73877205|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|16.7||||0.627|TWO_SIDED|95.0|-31.4|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||64.7|-31.4|0.627
73877206|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|2.4||||1|TWO_SIDED|95.0|-34.2|39.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||39.0|-34.2|1.000
73956923|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|59.44|||<|0.001|TWO_SIDED|95.0|45.69|73.19||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.19|45.69|<0.001
73956924|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|2.96||||0.642|TWO_SIDED|95.0|-9.52|15.44||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.44|-9.52|0.642
74000079|NCT02074553|147548523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.82|||||TWO_SIDED|90.0|90.71|105.48|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||105.48|90.71|
74000080|NCT02074553|147548523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.66|||||TWO_SIDED|90.0|80.32|93.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||93.5|80.32|
74000081|NCT02074553|147548523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.62|||||TWO_SIDED|90.0|85.15|92.24|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||92.24|85.15|
74000082|NCT02074553|147548523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.17|||||TWO_SIDED|90.0|77.08|83.39|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||83.39|77.08|
74000083|NCT02074553|147548523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|79.95|||||TWO_SIDED|90.0|76.84|83.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||83.19|76.84|
74000084|NCT02074553|147548524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|99.12|||||TWO_SIDED|90.0|91.83|106.99|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||106.99|91.83|
74008651|NCT00395863|147567365|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|25.04|STANDARD_DEVIATION|37.37||0.02||95.0|12.41|37.67||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||37.67|12.41|0.02
74008652|NCT00395863|147567366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.77|STANDARD_DEVIATION|48.51||0.0019||95.0|14.28|51.25||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||51.25|14.28|0.0019
73877207|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-4.8||||1|TWO_SIDED|95.0|-47.6|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||38.0|-47.6|1.000
73877208|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|25.0||||0.344|TWO_SIDED|95.0|-21.9|71.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||71.9|-21.9|0.344
73877209|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|25.0||||0.248|TWO_SIDED|95.0|-10.9|60.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||60.9|-10.9|0.248
73877210|NCT02365649|147294858|SUPERIORITY||Risk Difference (RD)|-10.7||||1|TWO_SIDED|95.0|-46.4|25.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||25.0|-46.4|1.000
74000085|NCT02074553|147548524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.79|||||TWO_SIDED|90.0|86.94|101.17|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||101.17|86.94|
74000086|NCT02074553|147548524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.32|||||TWO_SIDED|90.0|74.41|86.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||86.7|74.41|
74000087|NCT02074553|147548524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.42|||||TWO_SIDED|90.0|83.92|91.07|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.07|83.92|
74000088|NCT02074553|147548524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.87|||||TWO_SIDED|90.0|75.76|82.11|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||82.11|75.76|
74000089|NCT02074553|147548524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.66|||||TWO_SIDED|90.0|75.53|81.92|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||81.92|75.53|
74000090|NCT02074553|147548525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.34|||||TWO_SIDED|90.0|82.33|99.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||99.12|82.33|
74000091|NCT02074553|147548525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.28|||||TWO_SIDED|90.0|60.45|72.68|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.68|60.45|
74000092|NCT02074553|147548525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|41.04|||||TWO_SIDED|90.0|37.4|45.03|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||45.03|37.40|
74000093|NCT02074553|147548525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.3|||||TWO_SIDED|90.0|81.77|91.09|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.09|81.77|
74000094|NCT02074553|147548525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.0|||||TWO_SIDED|90.0|73.01|81.2|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||81.20|73.01|
74000095|NCT02074553|147548525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.65|||||TWO_SIDED|90.0|71.71|79.82|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.82|71.71|
74000096|NCT02074553|147548527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.67|||||TWO_SIDED|90.0|82.34|102.05|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||102.05|82.34|
74091721|NCT05472662|147737052|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.13||||0.815|TWO_SIDED|95.0|-1.24|0.99|||ANCOVA|||"Statistical analysis performed on the data at 1.5 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||0.99|-1.24|0.815
74000097|NCT02074553|147548527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.24|||||TWO_SIDED|90.0|60.44|74.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||74.79|60.44|
74000098|NCT02074553|147548527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|34.32|||||TWO_SIDED|90.0|30.83|38.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||38.21|30.83|
74000099|NCT02074553|147548527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.15|||||TWO_SIDED|90.0|89.1|101.62|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||101.62|89.10|
74000100|NCT02074553|147548527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||TWO_SIDED|90.0|68.67|78.16|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||78.16|68.67|
74000101|NCT02074553|147548527|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.76|||||TWO_SIDED|90.0|63.48|72.33|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.33|63.48|
74000102|NCT02074553|147548529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.77|||||TWO_SIDED|90.0|87.54|104.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||104.79|87.54|
74008653|NCT00395863|147567367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.61|STANDARD_DEVIATION|43.16||0.0008||95.0|16.75|50.47||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||50.47|16.75|0.0008
74008654|NCT00395863|147567368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.72|STANDARD_DEVIATION|48.5||0.0026||95.0|14.63|52.81||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||52.81|14.63|0.0026
74008655|NCT02592551|147567371|OTHER||Median Difference (Final Values)|8.6||||0.109|TWO_SIDED||||||Wilcoxon signed rank test|||Compare in ratios of intratumoral cytotoxic T cells to regulatory T cells (CD8/Treg) between pre and post of MEDI4736+Tremelimumab||||0.109
74008656|NCT02592551|147567372|OTHER|Compare the tissue biomarker for the immune response of ICOS+ CD4 T cells to before and after MEDI-4736 and Tremelimumab||||||1|||||||Wilcoxon signed rank test|||||||1
74008657|NCT02592551|147567373|OTHER|||||||0.461|||||||Wilcoxon signed rank test|||Compare tumor expression programmed death-ligand 1 (PD-L1) before and after treatment with combination MEDI-4736 and Tremelimumab||||0.461
74008658|NCT02592551|147567374|OTHER|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||Compare tissue biomarker immune response of CD8 and Treg (ratio of CD8/treg) after MEDI-4736 and Tremelimumab, and after MEDI4736 alone||||0.954
74008659|NCT02592551|147567375|OTHER|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||Compare tissue biomarker immune response of CD8 and Treg(ratio of CD8/Treg) after MEDI-4736 and Tremelimumab, and at day 1 of untread control group||||0.799
74000103|NCT02074553|147548529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.69|||||TWO_SIDED|90.0|71.97|86.04|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||86.04|71.97|
74000104|NCT02074553|147548529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|53.91|||||TWO_SIDED|90.0|49.27|58.98|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||58.98|49.27|
74000105|NCT02074553|147548529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.16|||||TWO_SIDED|90.0|86.14|94.37|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.37|86.14|
74000106|NCT02074553|147548529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.76|||||TWO_SIDED|90.0|70.52|77.15|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||77.15|70.52|
74000107|NCT02074553|147548529|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|70.94|||||TWO_SIDED|90.0|67.8|74.22|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||74.22|67.80|
74000108|NCT02074553|147548530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.05|||||TWO_SIDED|90.0|84.24|102.78|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||102.78|84.24|
74000109|NCT02074553|147548530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|74.35|||||TWO_SIDED|90.0|67.37|82.06|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||82.06|67.37|
74000110|NCT02074553|147548530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|43.94|||||TWO_SIDED|90.0|39.78|48.53|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||48.53|39.78|
74000111|NCT02074553|147548530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.21|||||TWO_SIDED|90.0|86.12|94.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.49|86.12|
74000112|NCT02074553|147548530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|72.72|||||TWO_SIDED|90.0|69.48|76.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||76.12|69.48|
74000113|NCT02074553|147548530|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|69.34|||||TWO_SIDED|90.0|66.23|72.61|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.61|66.23|
74000114|NCT02074553|147548533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|98.79|||||TWO_SIDED|90.0|91.25|106.95|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||106.95|91.25|
73877211|NCT02365649|147294859|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||5.0|-55.0|1.000
74000115|NCT02074553|147548533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.58|||||TWO_SIDED|90.0|84.65|99.08|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||99.08|84.65|
74000116|NCT02074553|147548533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.41|||||TWO_SIDED|90.0|67.81|79.47|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.47|67.81|
74000117|NCT02074553|147548533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.81|||||TWO_SIDED|90.0|85.62|92.13|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||92.13|85.62|
74000118|NCT02074553|147548533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.74|||||TWO_SIDED|90.0|74.99|80.6|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||80.60|74.99|
74000119|NCT02074553|147548533|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.65|||||TWO_SIDED|90.0|73.92|79.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.49|73.92|
74090661|NCT02040779|147735345|SUPERIORITY||LSM difference|-0.137||||0.0335|TWO_SIDED|95.0|-0.263|-0.011||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.011|-0.263|0.0335
74090662|NCT02040779|147735345|SUPERIORITY||LSM difference|-0.127||||0.0509|TWO_SIDED|95.0|-0.255|0.001||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||0.001|-0.255|0.0509
73877212|NCT02365649|147294859|SUPERIORITY||Risk Difference (RD)|25.0||||0.608|TWO_SIDED|95.0|-20.8|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||70.8|-20.8|0.608
74000120|NCT02074553|147548534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|89.41|||||TWO_SIDED|90.0|81.7|97.84|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||97.84|81.7|
74000121|NCT02074553|147548534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.84|||||TWO_SIDED|90.0|61.12|73.1|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||73.1|61.12|
74000122|NCT02074553|147548534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|42.32|||||TWO_SIDED|90.0|38.68|46.32|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||46.32|38.68|
74000123|NCT02074553|147548534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.76|||||TWO_SIDED|90.0|84.21|93.56|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||93.56|84.21|
74000124|NCT02074553|147548534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.82|||||TWO_SIDED|90.0|71.99|79.86|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.86|71.99|
74000125|NCT02074553|147548534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||TWO_SIDED|90.0|69.53|77.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||77.19|69.53|
74000126|NCT02074553|147548535|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.23|||||TWO_SIDED|90.0|89.85|105.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||105.21|89.85|
74000127|NCT02074553|147548535|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.16|||||TWO_SIDED|90.0|80.59|94.26|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.26|80.59|
74000128|NCT02074553|147548535|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.86|||||TWO_SIDED|90.0|62.71|73.43|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||73.43|62.71|
74036727|NCT04501679|147626855|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.|Strata-adjusted percentage difference|27.9|||<|0.0001|TWO_SIDED|95.0|18.4|37.5||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|||37.5|18.4|<0.0001
74036728|NCT04501679|147626856|SUPERIORITY||Strata-adjusted percentage difference|18.8|||<|0.0001|TWO_SIDED|95.0|12.0|25.7||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||25.7|12.0|<0.0001
74036729|NCT00186056|147626858|SUPERIORITY_OR_OTHER||||||<|0.26|||||||ANOVA|Interaction of HAMD \* medication group F(2,26)=1.38, eta sq = .05||||||<.26
74036730|NCT01968954|147626864|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-57.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.001|TWO_SIDED|95.0|-61.0|-53.1|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-53.1|-61.0|<0.001
74090663|NCT02040779|147735347|SUPERIORITY|||||||0.2384|||||||Log Rank|||||||0.2384
74090664|NCT02040779|147735347|SUPERIORITY|||||||0.0208|||||||Log Rank|||||||0.0208
74000129|NCT02074553|147548535|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.28|||||TWO_SIDED|90.0|85.06|91.63|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.63|85.06|
74000130|NCT02074553|147548535|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.79|||||TWO_SIDED|90.0|74.03|79.65|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.65|74.03|
74000131|NCT02074553|147548535|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.43|||||TWO_SIDED|90.0|72.7|78.27|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||78.27|72.70|
74000132|NCT02342743|147548561|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74000133|NCT02342743|147548562|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74000134|NCT02342743|147548563|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74090665|NCT00922272|147735364|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
74036731|NCT01968954|147626865|SUPERIORITY_OR_OTHER||LS mean difference|-36.2|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|-38.8|-33.6|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-33.6|-38.8|<0.001
74000135|NCT02342743|147548564|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74000136|NCT02342743|147548565|SUPERIORITY|||||||0.012||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.012
74000137|NCT02342743|147548566|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74000138|NCT02342743|147548568|SUPERIORITY|||||||0.03||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.030
74000139|NCT04187989|147548577|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.006|STANDARD_ERROR_OF_MEAN|0.239||0.98|TWO_SIDED|95.0|-0.478|0.466|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.466|-.478|.980
74000140|NCT04187989|147548578|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.265|STANDARD_ERROR_OF_MEAN|0.18||0.14|TWO_SIDED|95.0|-0.092|0.621||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.621|-.092|.140
74000141|NCT04187989|147548580|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.064|STANDARD_ERROR_OF_MEAN|0.181||0.724|TWO_SIDED|95.0|-0.294|0.421||Two-sided test of the null hypothesis of no difference between groups|t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.421|-.294|.724
74000142|NCT04187989|147548581|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.078|STANDARD_ERROR_OF_MEAN|0.175||0.656|TWO_SIDED|95.0|-0.425|0.269|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.269|-.425|.656
74000143|NCT04187989|147548582|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.339|STANDARD_ERROR_OF_MEAN|0.205||0.158|TWO_SIDED|95.0|-0.746|0.067||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|||0.067|-.746|.158
74000144|NCT04187989|147548583|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.143|STANDARD_ERROR_OF_MEAN|0.178||0.422|TWO_SIDED|95.0|-0.21|0.495|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.495|-.210|.422
74008660|NCT02592551|147567378|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||Compare tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and after MEDI-4736 alone||||0.418
74008661|NCT02592551|147567379|OTHER|||||||0.932|||||||Wilcoxon (Mann-Whitney)|||Compare tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and before and at day 1 of untreated||||0.932
74008662|NCT01338415|147567427|OTHER||Hazard Ratio (HR)|1.438|||||TWO_SIDED|95.0|0.47|4.399|||Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)||4.399|0.470|
74036732|NCT01968954|147626865|SUPERIORITY_OR_OTHER||LS mean difference|-34.7|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|95.0|-37.7|-31.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-31.7|-37.7|
74036733|NCT01968954|147626865|SUPERIORITY_OR_OTHER||LS mean difference|-29.0|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|95.0|-32.3|-25.7||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-25.7|-32.3|
74036734|NCT01968954|147626866|SUPERIORITY_OR_OTHER||LS mean difference|-51.6|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-55.2|-48.1|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-48.1|-55.2|<0.001
74036735|NCT01968954|147626866|SUPERIORITY_OR_OTHER||LS mean Difference|-50.6|STANDARD_ERROR_OF_MEAN|2.15|||TWO_SIDED|95.0|-54.9|-46.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-46.4|-54.9|
74000145|NCT04187989|147548584|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.027|STANDARD_ERROR_OF_MEAN|0.179||0.882|TWO_SIDED|95.0|-0.328|0.381|||t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs||.381|-.328|.882
74000146|NCT04187989|147548585|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.197|STANDARD_ERROR_OF_MEAN|0.268||0.497|TWO_SIDED|95.0|-0.728|0.334||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.334|-.728|.497
74000147|NCT04187989|147548586|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.042|STANDARD_ERROR_OF_MEAN|0.18||0.813|TWO_SIDED|95.0|-0.398|0.313||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.313|-.398|.813
74000148|NCT04187989|147548587|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.034|STANDARD_ERROR_OF_MEAN|0.176||0.849|TWO_SIDED|95.0|-0.381|0.314||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.314|-.381|.849
74000149|NCT04187989|147548588|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.118|STANDARD_ERROR_OF_MEAN|0.247||0.667|TWO_SIDED|95.0|-0.607|0.371||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.371|-.607|.667
74000150|NCT04187989|147548589|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.342|STANDARD_ERROR_OF_MEAN|0.175||0.051|TWO_SIDED|95.0|-0.689|0.005|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs||.005|-.689|.051
74000151|NCT04187989|147548590|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.064|STANDARD_ERROR_OF_MEAN|0.176||0.714|TWO_SIDED|95.0|-0.412|0.284|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model||We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|.284|-.412|.714
74000152|NCT04187989|147548591|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.11|STANDARD_ERROR_OF_MEAN|0.212||0.603|TWO_SIDED|95.0|-0.531|0.311|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|: We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.311|-.531|.603
74000153|NCT04187989|147548592|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.162|STANDARD_ERROR_OF_MEAN|0.219||0.457|TWO_SIDED|95.0|-0.273|0.597|||Cohen's D|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects)|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.597|-.273|.457
74000154|NCT04187989|147548593|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.265|STANDARD_ERROR_OF_MEAN|0.212||0.209|TWO_SIDED|95.0|-0.686|0.156|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.156|-.686|.209
74000155|NCT04187989|147548594|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.107|STANDARD_ERROR_OF_MEAN|0.219||0.623|TWO_SIDED|95.0|-0.541|0.328|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects)|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.328|-.541|.623
74000156|NCT00092495|147548609|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000157|NCT00092495|147548609|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000158|NCT00092495|147548610|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000159|NCT00092495|147548610|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74090666|NCT00922272|147735366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.4182|TWO_SIDED|95.0|-3.4|8.1|||ANCOVA|||||8.1|-3.4|0.4182
74090667|NCT00922272|147735367|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6705||95.0|||||Fisher Exact|||||||0.6705
73877213|NCT02365649|147294859|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||5.0|-55.0|0.487
74000160|NCT00092495|147548611|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000161|NCT00092495|147548611|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000162|NCT00092495|147548611|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000163|NCT00092495|147548612|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000164|NCT00092495|147548612|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000165|NCT00092495|147548612|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000166|NCT00092495|147548613|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000167|NCT00092495|147548613|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000168|NCT00092495|147548614|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
74000169|NCT00092495|147548614|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
74000170|NCT00092495|147548615|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000171|NCT00092495|147548615|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000172|NCT00092495|147548615|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000173|NCT00092495|147548616|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000174|NCT00092495|147548616|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
74000175|NCT00092495|147548616|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74090668|NCT00922272|147735368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Affective Flattening||||<0.0001
74000176|NCT00092495|147548617|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000177|NCT00092495|147548617|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000178|NCT00092495|147548618|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000179|NCT00092495|147548618|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000180|NCT00092495|147548619|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.01||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.01
74000181|NCT00092495|147548619|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000182|NCT00092495|147548619|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000183|NCT00092495|147548620|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74090669|NCT00922272|147735368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Alogia||||<0.0001
73877214|NCT02365649|147294859|SUPERIORITY||Risk Difference (RD)|20.0||||0.25|TWO_SIDED|95.0|-15.1|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||55.1|-15.1|0.250
73877215|NCT02365649|147294859|SUPERIORITY||Risk Difference (RD)|8.3||||0.444|TWO_SIDED|95.0|-7.3|24.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||24.0|-7.3|0.444
73877216|NCT02365649|147294859|SUPERIORITY||Risk Difference (RD)|11.1||||0.375|TWO_SIDED|95.0|-9.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||31.6|-9.4|0.375
73877217|NCT02365649|147294859|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-31.1|37.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||37.8|-31.1|1.000
73877218|NCT02365649|147294859|SUPERIORITY||Risk Difference (RD)|22.4||||0.215|TWO_SIDED|95.0|-8.0|52.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||52.8|-8.0|0.215
74000184|NCT00092495|147548620|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000185|NCT00092495|147548620|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000186|NCT00092495|147548621|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000187|NCT00092495|147548621|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000188|NCT00092495|147548622|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000189|NCT00092495|147548622|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000190|NCT00092495|147548623|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000191|NCT00092495|147548623|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000192|NCT00092495|147548623|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
74000193|NCT00092495|147548624|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000194|NCT00092495|147548624|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74036736|NCT01968954|147626866|SUPERIORITY_OR_OTHER||LS mean difference|-41.2|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-45.8|-36.5||||||Week 52:LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-36.5|-45.8|
74000195|NCT00092495|147548624|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
74000196|NCT04587752|147548666|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
74000197|NCT04587752|147548667|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
74000198|NCT04587752|147548668|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
74000199|NCT00652327|147548683|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||Wilcoxon rank sum test|||||||.0026
74000200|NCT02926898|147548692|SUPERIORITY||Percent difference|-54.0|||<|0.001|TWO_SIDED|95.0|-67.2|-35.6||Analysis of covariance (ANCOVA) model with treatment group (ZX008 or placebo) and age group (\< 6 years, ≥ 6 years) as factors, and with log baseline frequency as a covariate, and log CSF as the outcome variable.|ANCOVA|||||-35.6|-67.2|<0.001
74000201|NCT02926898|147548693|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|A logistic regression model using a categorical response variable as a function of Treatment group, Baseline seizure frequency, and age group.||||||<0.001
74000202|NCT02926898|147548694|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
74000203|NCT03535597|147548715|OTHER||Risk Ratio (RR)|0.99||||0.906|TWO_SIDED|95.0|0.89|1.11|||Chi-squared|||||1.11|0.89|0.906
74000204|NCT03535597|147548715|OTHER||Risk Ratio (RR)|1.27||||0.002|TWO_SIDED|95.0|1.09|1.53|||Chi-squared|||||1.53|1.09|0.002
73877219|NCT02365649|147294859|SUPERIORITY||Risk Difference (RD)|-0.8||||1|TWO_SIDED|95.0|-29.5|27.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||27.8|-29.5|1.000
73877220|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-15.0||||0.671|TWO_SIDED|95.0|-55.5|25.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||25.5|-55.5|0.671
73877221|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|10.0||||0.718|TWO_SIDED|95.0|-19.8|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||39.8|-19.8|0.718
73877222|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-15.0||||0.461|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||22.4|-52.4|0.461
74000205|NCT03535597|147548715|OTHER||Risk Ratio (RR)|0.97||||0.613|TWO_SIDED|95.0|0.86|1.09|||Chi-squared|||||1.09|0.86|0.613
74000206|NCT03535597|147548716|OTHER||Mean Difference (Net)|-98.5|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
74000207|NCT03535597|147548716|OTHER||Mean Difference (Net)|-120.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
74000208|NCT03535597|147548716|OTHER||Mean Difference (Net)|-94.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
74090670|NCT00922272|147735368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Avolition-Apathy||||<0.0001
74000209|NCT03535597|147548717|OTHER||Risk Ratio (RR)|0.77||||0.744|TWO_SIDED|95.0|0.23|2.57|||Fisher Exact|||||2.57|0.23|0.744
74000210|NCT03535597|147548717|OTHER||Risk Ratio (RR)|1.02|||>|0.999|TWO_SIDED|95.0|0.31|3.41|||Fisher Exact|||||3.41|0.31|>0.999
74000211|NCT03535597|147548717|OTHER||Risk Ratio (RR)|0.67||||0.724|TWO_SIDED|95.0|0.18|2.46|||Fisher Exact|||||2.46|0.18|0.724
74000212|NCT03535597|147548718|OTHER||Risk Ratio (RR)|1.44||||0.594|TWO_SIDED|95.0|0.56|3.76|||Fisher Exact|||||3.76|0.56|0.594
74000213|NCT03535597|147548718|OTHER||Risk Ratio (RR)|1.1|||>|0.999|TWO_SIDED|95.0|0.37|3.26|||Fisher Exact|||||3.26|0.37|>0.999
74000214|NCT03535597|147548718|OTHER||Risk Ratio (RR)|1.45||||0.581|TWO_SIDED|95.0|0.55|3.88|||Fisher Exact|||||3.88|0.55|0.581
74000215|NCT03535597|147548719|OTHER||Risk Ratio (RR)|1.92||||0.284|TWO_SIDED|95.0|0.71|5.22|||Fisher Exact|||||5.22|0.71|0.284
74000216|NCT03535597|147548719|OTHER||Risk Ratio (RR)|2.1||||0.243|TWO_SIDED|95.0|0.75|5.9|||Fisher Exact|||||5.9|0.75|0.243
74000217|NCT03535597|147548719|OTHER||Risk Ratio (RR)|2.01||||0.266|TWO_SIDED|95.0|0.74|5.54|||Fisher Exact|||||5.54|0.74|0.266
74000218|NCT01226095|147548721|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
74000219|NCT05326815|147548771|OTHER|Spearman Correlation.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
74000220|NCT02545933|147548775|SUPERIORITY||least square mean difference|27.0||||0.011|TWO_SIDED|95.0|19.0|34.0|||ANOVA||DAPT group vs DAPT plus vorapaxar group|We hypothesized that adjunctive vorapaxar would result in a significant reduction of CAT-induced platelet aggregation. Assuming a 10% absolute reduction in CAT-induced maximal platelet aggregation with a common standard deviation of 13%, 37 patients per group with valid primary endpoint data were required to detect a significant difference with a 90% power and 2-sided alpha=0.05.||34|19|0.011
74000221|NCT00935818|147548778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.03|TWO_SIDED|95.0|1.05|2.12|||Regression, Logistic|||Logistic regression with covariate included for study site.||2.12|1.05|0.03
74000222|NCT00935818|147548779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.03|TWO_SIDED|95.0|1.04|2.22|||Regression, Logistic|||Logistic Regression - adjusting for study site||2.22|1.04|0.03
74000223|NCT00935818|147548780|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||< 0.001
74000224|NCT00935818|147548781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.93|||Regression, Logistic|||Logistic regression adjusted for study site||1.93|0.95|0.09
74000225|NCT00935818|147548782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.14|TWO_SIDED|95.0|0.91|1.91|||Regression, Logistic|||Logistic Regression adjusting for study site||1.91|0.91|0.14
74000226|NCT00935818|147548783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.11|TWO_SIDED|95.0|0.93|2.07|||Regression, Logistic|||Logistic Regression - adjusting for study site||2.07|0.93|0.11
74000227|NCT00935818|147548784|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.08|TWO_SIDED|95.0|0.96|2.05|||Regression, Logistic|||Logistic Regression - adjusting for site||2.05|0.96|0.08
74000228|NCT00715962|147548826|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|Fisher's exact test used as the rate of falling was low.||||||<.05
74000229|NCT00715962|147548827|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
74000230|NCT00107120|147548832|SUPERIORITY_OR_OTHER||Least Square Means Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.458||0.022||95.0|-6.2|-0.5||Two-sided at 5% level of significance p \< 0.05 considered significant|ANCOVA|The model included study center and treatment as factors and baseline core as covariate|Differences are Escitalopram-Placebo|The null hypothesis is that there is no difference in the Change from Baseline to Week 8 in CDRS-R total score between treatment groups. The power calculation was based on the change from baseline to Week 8 in CDRS-R total score (LOCF approach). Assuming an effect size (treatment group difference relative to standard deviation) of 0.325, a sample size of approximately 150 patients per treatment group was used to provide at least 80% power at a significance level of 0.05 using a two-sided test.||-0.5|-6.2|0.022
74000231|NCT00107120|147548833|SUPERIORITY_OR_OTHER||Least Square Means Difference|-0.344|STANDARD_ERROR_OF_MEAN|0.1128||0.008||95.0|-0.595|0.092||Two-sided at 5% level of significance|ANCOVA|The model included treatment and center as factors and baseline CGI-Severity score as covariate.|Differences are Escitalopram-Placebo|Missing values were imputed using the LOCF approach.||0.092|-0.595|0.008
74000232|NCT00107120|147548834|SUPERIORITY_OR_OTHER||Least Square Means Difference|2.169|STANDARD_ERROR_OF_MEAN|1.324||0.103||95.0|-0.439|4.777||Two-sided at 5% level of significance|ANCOVA||Differences are Escitalopram-Placebo|ANCOVA on the Change from Baseline to Week 8 in CGAS score. The model included treatment and center as factors and baseline score as covariate. Missing values were imputed using the LOCF approach.||4.777|-0.439|0.103
74000233|NCT00686725|147548855|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||Log Rank|||||||0.183
74000234|NCT00686725|147548856|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Log Rank|||||||0.35
74000235|NCT00686725|147548859|SUPERIORITY_OR_OTHER|||||||0.648||95.0|||||Log Rank|||||||0.648
74000236|NCT00686725|147548860|SUPERIORITY_OR_OTHER|||||||0.915||95.0|||||Log Rank|||||||0.915
74000237|NCT02630693|147548867|OTHER|As stated in the protocol, the primary objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for progression free survival.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|90.0|0.66|1.3|||||Hazard ratio of Palbociclib100mg arm vs 125 mg arm|||1.30|0.66|
74000238|NCT02630693|147548870|OTHER|As stated in the protocol, the objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for overall survival.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|90.0|0.67|1.69|||||Hazard ratio for Palbociclib 100mg arm vs 125 mg arm|||1.69|0.67|
74000239|NCT01639560|147548871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.7|||<|0.001|TWO_SIDED|95.0|2.5|18.1|||Regression, Logistic|||||18.1|2.5|<0.001
74000240|NCT01639560|147548872|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.33||||0.001|TWO_SIDED|95.0|2.2|24.0|||Regression, Logistic|||||24.0|2.2|0.001
73877223|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-50.0||||0.03|TWO_SIDED|95.0|-85.5|-14.5||Statistically significant at 0.05 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||-14.5|-85.5|0.030
74000241|NCT01639560|147548873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.047|TWO_SIDED|95.0|1.0|6.3|||Regression, Logistic|||||6.3|1.0|0.047
74000242|NCT01639560|147548874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.009|TWO_SIDED|95.0|1.5|16.5|||Regression, Logistic|||||16.5|1.5|0.009
74000243|NCT01160289|147548875|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|Treatment group (tx grp), baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.||Only the treatment effects of 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.||||0.5
74000244|NCT01160289|147548875|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|The model included tx grp, baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.||Only the treatment effects of the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.||||0.498
74000245|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.178|STANDARD_ERROR_OF_MEAN|3.312||0.722||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.722
74000246|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.552|STANDARD_ERROR_OF_MEAN|3.253||0.634||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.634
74000247|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-4.674|STANDARD_ERROR_OF_MEAN|3.218||0.147||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.147
74000248|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.404|STANDARD_ERROR_OF_MEAN|3.157||0.02||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.020
74000249|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.33|STANDARD_ERROR_OF_MEAN|4.658||0.775||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.775
74000250|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.844|STANDARD_ERROR_OF_MEAN|4.573||0.687||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.687
74000251|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.092|STANDARD_ERROR_OF_MEAN|4.535||0.119||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.119
74000252|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-6.578|STANDARD_ERROR_OF_MEAN|4.45||0.14||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.140
74000253|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|6.703|STANDARD_ERROR_OF_MEAN|5.302||0.207||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.207
74090671|NCT00922272|147735368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Anhedonia-Asociality||||<0.0001
73877224|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-12.5||||0.483|TWO_SIDED|95.0|-42.9|17.9|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||17.9|-42.9|0.483
73877225|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-15.0||||0.431|TWO_SIDED|95.0|-50.8|20.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||20.8|-50.8|0.431
73877226|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-31.1|41.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||41.1|-31.1|1.000
73877227|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-7.5||||0.635|TWO_SIDED|95.0|-38.6|23.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||23.6|-38.6|0.635
73877228|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-40.0||||0.056|TWO_SIDED|95.0|-74.8|-5.2||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||-5.2|-74.8|0.056
73877229|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||32.5|-47.5|1.000
73877230|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|17.5||||0.296|TWO_SIDED|95.0|-14.7|49.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||49.7|-14.7|0.296
73877231|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.4|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||32.4|-42.4|1.000
73877232|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-45.9|35.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||35.9|-45.9|1.000
73877233|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|13.8||||0.4|TWO_SIDED|95.0|-17.7|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||45.2|-17.7|0.400
73877234|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-15.0||||0.439|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||22.4|-52.4|0.439
73877235|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|21.9||||0.259|TWO_SIDED|95.0|-12.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||56.6|-12.8|0.259
73877236|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-10.5||||0.31|TWO_SIDED|95.0|-30.6|9.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||9.7|-30.6|0.310
73877237|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-19.4||||0.097|TWO_SIDED|95.0|-38.8|-0.1||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||-0.1|-38.8|0.097
74000254|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|9.159|STANDARD_ERROR_OF_MEAN|5.206||0.079||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.079
74000255|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-5.349|STANDARD_ERROR_OF_MEAN|5.165||0.301||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.301
73877238|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|24.4||||0.181|TWO_SIDED|95.0|-8.5|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||57.2|-8.5|0.181
74000256|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-2.893|STANDARD_ERROR_OF_MEAN|5.067||0.568||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.568
74000257|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|4.079|STANDARD_ERROR_OF_MEAN|5.566||0.464||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.464
74000258|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|5.054|STANDARD_ERROR_OF_MEAN|5.463||0.356||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.356
74000259|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-11.266|STANDARD_ERROR_OF_MEAN|5.418||0.038||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.038
74000260|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-10.292|STANDARD_ERROR_OF_MEAN|5.312||0.054||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.054
74000261|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|4.202|STANDARD_ERROR_OF_MEAN|5.603||0.454||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.454
74000262|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|5.796|STANDARD_ERROR_OF_MEAN|5.499||0.293||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.293
74000263|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-8.808|STANDARD_ERROR_OF_MEAN|5.457||0.107||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.107
74000264|NCT01160289|147548876|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.214|STANDARD_ERROR_OF_MEAN|5.349||0.178||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.178
73956925|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
74000265|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.079|STANDARD_ERROR_OF_MEAN|0.472||0.867||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.867
74000266|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.039|STANDARD_ERROR_OF_MEAN|0.458||0.931||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.931
74000267|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.652|STANDARD_ERROR_OF_MEAN|0.46||0.158||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.158
74000268|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.612|STANDARD_ERROR_OF_MEAN|0.447||0.172||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.172
74000269|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.223|STANDARD_ERROR_OF_MEAN|0.401||0.579||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.579
74000270|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.616|STANDARD_ERROR_OF_MEAN|0.39||0.115||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.115
74000271|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.168|STANDARD_ERROR_OF_MEAN|0.392||0.668||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.668
74000272|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.561|STANDARD_ERROR_OF_MEAN|0.38||0.141||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.141
74000273|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.088|STANDARD_ERROR_OF_MEAN|0.258||0.734||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.734
74000274|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.179|STANDARD_ERROR_OF_MEAN|0.251||0.477||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.477
74000275|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.3|STANDARD_ERROR_OF_MEAN|0.252||0.235||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.235
74000276|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.391|STANDARD_ERROR_OF_MEAN|0.245||0.111||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.111
74000277|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.349|STANDARD_ERROR_OF_MEAN|0.343||0.31||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.310
73877239|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|2.0||||0.826|TWO_SIDED|95.0|-15.9|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||20.0|-15.9|0.826
74000278|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.568|STANDARD_ERROR_OF_MEAN|0.334||0.09||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.090
74000279|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.729|STANDARD_ERROR_OF_MEAN|0.335||0.03||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.030
74000280|NCT01160289|147548877|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.948|STANDARD_ERROR_OF_MEAN|0.326||0.004||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.004
74000281|NCT01160289|147548879|SUPERIORITY_OR_OTHER|||||||0.656||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.656
74000282|NCT01160289|147548879|SUPERIORITY_OR_OTHER|||||||0.46||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.460
74000283|NCT01160289|147548879|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.198
73877240|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-21.2|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||16.1|-21.2|1.000
74000284|NCT01160289|147548879|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.009
74000285|NCT01160289|147548879|SUPERIORITY_OR_OTHER|||||||0.671||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.671
74000286|NCT01160289|147548879|SUPERIORITY_OR_OTHER|||||||0.259||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.259
74000287|NCT01160289|147548879|SUPERIORITY_OR_OTHER|||||||0.441||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.441
74090672|NCT00922272|147735368|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Attention||||<0.0001
74090673|NCT00922272|147735369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.8771|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Affective Flattening||0.5|-0.4|0.8771
74090674|NCT00922272|147735369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.0584|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Alogia||1.1|0.0|0.0584
74090675|NCT00922272|147735369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.5215|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Avolition-Apathy||0.6|-0.3|0.5215
74090676|NCT00922272|147735369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.4835|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Anhedonia-Asociality||0.7|-0.3|0.4835
74090677|NCT00922272|147735369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.5723|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Attention||0.7|-0.4|0.5723
74090678|NCT00922272|147735370|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Positive subscale||||<0.0001
74090679|NCT00922272|147735370|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Negative subscale||||<0.0001
74090680|NCT00922272|147735370|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||General Psychopathology subscale||||<0.0001
73877241|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|14.4||||0.369|TWO_SIDED|95.0|-16.7|45.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||45.4|-16.7|0.369
73877242|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-0.9||||1|TWO_SIDED|95.0|-18.2|16.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||16.4|-18.2|1.000
73877243|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-21.2|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||16.1|-21.2|1.000
73877244|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|11.3||||0.66|TWO_SIDED|95.0|-20.2|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||42.7|-20.2|0.660
73877245|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-1.1||||0.908|TWO_SIDED|95.0|-19.7|17.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||17.5|-19.7|0.908
73877246|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-10.1||||0.446|TWO_SIDED|95.0|-27.8|7.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||7.7|-27.8|0.446
74000288|NCT01160289|147548879|SUPERIORITY_OR_OTHER|||||||0.433||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.433
73956926|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
73956927|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
73956928|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
73956929|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
73956930|NCT01362491|147449742|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
73956931|NCT01362491|147449745|SUPERIORITY_OR_OTHER||Difference in proportion|3.21||||0.389|TWO_SIDED|95.0|-3.12|9.55||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.55|-3.12|0.389
73956932|NCT01362491|147449745|SUPERIORITY_OR_OTHER||Difference in proportion|2.35||||0.49|TWO_SIDED|95.0|-3.69|8.39||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.39|-3.69|0.490
73956933|NCT01362491|147449745|SUPERIORITY_OR_OTHER||Difference in proportion|0.98||||0.764|TWO_SIDED|95.0|-5.45|7.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.41|-5.45|0.764
74000289|NCT01160289|147548880|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.13||||0.423||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.423
73877247|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|20.6||||0.135|TWO_SIDED|95.0|-9.5|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||50.8|-9.5|0.135
73877248|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|11.2||||0.306|TWO_SIDED|95.0|-5.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||28.1|-5.7|0.306
73877249|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||20.7|-13.4|0.686
73877250|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|4.9||||0.754|TWO_SIDED|95.0|-25.4|35.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||35.2|-25.4|0.754
73877251|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-7.7||||0.548|TWO_SIDED|95.0|-32.6|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||17.3|-32.6|0.548
73877252|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-22.5||||0.12|TWO_SIDED|95.0|-50.1|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||5.0|-50.1|0.120
73956934|NCT01362491|147449745|SUPERIORITY_OR_OTHER||Difference in proportion|28.71|||<|0.001|TWO_SIDED|95.0|15.72|41.7||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||41.70|15.72|<0.001
73956935|NCT01362491|147449745|SUPERIORITY_OR_OTHER||Difference in proportion|29.37|||<|0.001|TWO_SIDED|95.0|16.19|42.56||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||42.56|16.19|<0.001
73956936|NCT01362491|147449745|SUPERIORITY_OR_OTHER||Difference in proportion|-0.93||||0.898|TWO_SIDED|95.0|-15.22|13.36||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|-15.22|0.898
73956937|NCT01090024|147449775|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.083|STANDARD_ERROR_OF_MEAN|0.624||0.4473|TWO_SIDED|95.0|-1.147|1.313|||Mixed effect model||Adjusted means difference of BI 671800 200 mg BID (D) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.313|-1.147|0.4473
73956938|NCT01090024|147449775|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.67|STANDARD_ERROR_OF_MEAN|0.625||0.1426|TWO_SIDED|95.0|-0.563|1.903|||Mixed effect model||Adjusted means difference of BI 671800 400 mg PM QD (C) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.903|-0.563|0.1426
73956939|NCT01090024|147449775|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.281|STANDARD_ERROR_OF_MEAN|0.611||0.3231|TWO_SIDED|95.0|-0.924|1.486|||Mixed effect model||Adjusted means difference of BI 671800 400 mg AM QD (B) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.486|-0.924|0.3231
73956940|NCT01090024|147449776|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.056|STANDARD_ERROR_OF_MEAN|0.063||0.1879|TWO_SIDED|95.0|-0.18|0.068|||Mixed effect model||Adjusted means difference of BI 671800 200 mg BID (D) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.068|-0.180|0.1879
73956941|NCT01090024|147449776|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.026|STANDARD_ERROR_OF_MEAN|0.063||0.3384|TWO_SIDED|95.0|-0.151|0.098|||Mixed effect model||Adjusted means difference of BI 671800 400 mg PM QD (C) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.098|-0.151|0.3384
73877253|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-13.4||||0.403|TWO_SIDED|95.0|-44.5|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||17.7|-44.5|0.403
73877254|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-8.0||||0.533|TWO_SIDED|95.0|-33.0|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||17.0|-33.0|0.533
73877255|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-8.9||||0.539|TWO_SIDED|95.0|-37.2|19.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||19.4|-37.2|0.539
73877256|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|4.9||||0.754|TWO_SIDED|95.0|-25.4|35.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||35.2|-25.4|0.754
73877257|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-14.5||||0.256|TWO_SIDED|95.0|-39.4|10.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||10.3|-39.4|0.256
74000290|NCT01160289|147548880|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.12||||0.443||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.443
73877258|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-27.8||||0.055|TWO_SIDED|95.0|-54.7|-0.8||Statistically significant at 0.1 level.|Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||-0.8|-54.7|0.055
74000291|NCT01160289|147548880|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.084||||0.599||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.599
74000292|NCT01160289|147548880|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.334||||0.029||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.029
74000293|NCT01160289|147548881|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-0.152||||0.148||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.148
74000294|NCT01160289|147548881|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.216||||0.033||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.033
73877259|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|2.2||||0.887|TWO_SIDED|95.0|-28.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||33.2|-28.8|0.887
73877260|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|14.5||||0.256|TWO_SIDED|95.0|-10.3|39.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||39.4|-10.3|0.256
74000295|NCT01160289|147548881|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.124||||0.224||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.224
74000296|NCT01160289|147548881|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.189||||0.056||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.056
74000297|NCT01160289|147548881|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.211||||0.031||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.031
74000298|NCT01160289|147548881|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.227||||0.017||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.017
74000299|NCT01160289|147548881|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.016||||0.866||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.866
74000300|NCT01160289|147548881|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.032||||0.726||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.726
74000301|NCT01160289|147548882|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-9.014|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
74000302|NCT01160289|147548882|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-18.547|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
74000303|NCT01160289|147548882|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-9.216|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
74000304|NCT01160289|147548882|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-18.75|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
74000305|NCT01160289|147548882|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.977||||0.776||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.776
74000306|NCT01160289|147548882|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.78||||0.814||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.814
74036737|NCT01968954|147626867|SUPERIORITY_OR_OTHER||LS mean difference|-51.5|STANDARD_ERROR_OF_MEAN|1.84|<|0.001|TWO_SIDED|95.0|-55.1|-47.9|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-47.9|-55.1|<0.001
74036738|NCT01968954|147626867|SUPERIORITY_OR_OTHER||LS mean difference|-50.6|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-54.6|-46.6||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-46.6|-54.6|
74036739|NCT01968954|147626867|SUPERIORITY_OR_OTHER||LS mean difference|-40.8|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-45.2|-36.3||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-36.3|-45.2|
74000307|NCT01160289|147548882|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.629||||0.627||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.627
74000308|NCT01160289|147548882|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.128||||0.968||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.968
74000309|NCT01160289|147548883|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-0.006||||0.984||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.984
74000310|NCT01160289|147548883|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.465||||0.076||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.076
74000311|NCT01160289|147548883|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.387||||0.142||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.142
74090681|NCT00922272|147735371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.1975|TWO_SIDED|95.0|-0.3|1.5|||ANCOVA|||Positive subscale||1.5|-0.3|0.1975
74000312|NCT01160289|147548883|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.072||||0.776||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.776
74000313|NCT01160289|147548884|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|5.031||||0.103||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.103
74000314|NCT01160289|147548884|SUPERIORITY_OR_OTHER||LS mean treatment difference|-3.225||||0.277||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.277
74000315|NCT01160289|147548884|SUPERIORITY_OR_OTHER||LS mean of treatment difference|7.056||||0.019||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.019
74000316|NCT01160289|147548884|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.201||||0.676||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.676
74000317|NCT01156792|147548902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|||=|0.268|TWO_SIDED|95.0|-0.02|0.07|||Mixed Models Analysis|||||0.07|-0.02|=0.268
74000318|NCT01156792|147548902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|||=|0.08|TWO_SIDED|95.0|0.0|0.09|||Mixed Models Analysis|||||0.09|-0.00|=0.080
74000319|NCT01156792|147548902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|||=|0.017|TWO_SIDED|95.0|0.01|0.1|||Mixed Models Analysis|||||0.10|0.01|=0.017
74090682|NCT00922272|147735371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.1228|TWO_SIDED|95.0|-0.3|2.3|||ANCOVA|||Negative subscale||2.3|-0.3|0.1228
74090683|NCT00922272|147735371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.1115|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA|||General Psychopathology subscale||3.9|-0.4|0.1115
74090684|NCT00922272|147735378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0307||95.0|||||t-test, 2 sided|||||||0.0307
74090685|NCT00922272|147735379|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1072|TWO_SIDED|95.0|-0.6|6.2|||ANCOVA|||||6.2|-0.6|0.1072
74090686|NCT00922272|147735380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.366||95.0|||||t-test, 2 sided|||||||0.3660
74090687|NCT00922272|147735381|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4347|TWO_SIDED|95.0|-5.0|2.2|||ANCOVA|||||2.2|-5.0|0.4347
73956942|NCT01090024|147449776|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.093|STANDARD_ERROR_OF_MEAN|0.062||0.067|TWO_SIDED|95.0|-0.214|0.029|||Mixed effect model||Adjusted means difference of BI 671800 400 mg AM QD (B) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.029|-0.214|0.0670
73956943|NCT00470626|147449788|SUPERIORITY_OR_OTHER||Probability of Successful Retrieval|0.9||||||95.0|||||||Probability of successful retrieval is from Kaplan-Meier analysis.|||||
73956944|NCT01729819|147449800|SUPERIORITY|The change in mean nocturnal voids from baseline as the dependent variable, baseline mean nocturnal voids as a covariate, and treatments and visit (Month 1, Month 2, and Month 3) as factors, was considered for the analysis. Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. Missing values post-baseline were not imputed.|Mean Difference (Final Values)|-0.34||||0.112|TWO_SIDED|95.0|-0.77|0.08|||ANCOVA|Change in mean nocturnal voids as the dependent variable and baseline mean nocturnal voids as a covariate, treatment and visit as factors.|Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented. The trial was to be declared positive if a statistically significant (two-sided, p \< 0.05) positive effect for combining tolterodine and desmopressin compared to tolterodine monotherapy on the primary endpoint had been demonstrated.||0.08|-0.77|0.112
73956945|NCT01729819|147449801|SUPERIORITY||Mean Difference (Final Values)|18.0||||0.385|TWO_SIDED|95.0|-22.96|58.96|||ANCOVA|Change in mean time to first void as dependent variable and baseline mean time to first void as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented.||58.96|-22.96|0.385
73956946|NCT01729819|147449802|SUPERIORITY||Mean Difference (Final Values)|-64.16||||0.103|TWO_SIDED|95.0|-141.46|13.14|||ANCOVA|Change in mean nocturnal volume as the dependent variable and baseline mean nocturnal volume as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented||13.14|-141.46|0.103
73956947|NCT01729819|147449803|SUPERIORITY||Odds Ratio (OR)|1.36||||0.352|TWO_SIDED|95.0|0.71|2.62||33% responder status as dependent variable, baseline mean nocturnal voids as covariate, treatment, and visit as factors.|Generalized Estimating Equation|||Combination versus tolterodine (i.e. odds of being responder in combination group versus odds of being responder in tolterodine group) is presented. The proportion of responders during three months of treatment was analysed (i.e. the odds ratio of the odds of being a responder) longitudinally using Generalised Estimating Equation (GEE) for a repeated logistic regression.||2.62|0.71|0.352
73956948|NCT01729819|147449804|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.443||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 1|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 1||||0.443
74000320|NCT01156792|147548902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|||=|0.002|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||||0.12|0.03|=0.002
74000321|NCT01156792|147548903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.946|||=|0.751|TWO_SIDED|95.0|-4.91|6.81|||Mixed Models Analysis|||||6.81|-4.91|=0.751
74000322|NCT01156792|147548903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.771|||=|0.049|TWO_SIDED|95.0|0.03|11.51|||Mixed Models Analysis|||||11.51|0.03|=0.049
74000323|NCT01156792|147548903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.983|||=|0.123|TWO_SIDED|95.0|-1.35|11.32|||Mixed Models Analysis|||||11.32|-1.35|=0.123
74000324|NCT01156792|147548903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.14|||<|0.001|TWO_SIDED|95.0|5.93|18.35|||Mixed Models Analysis|||||18.35|5.93|<0.001
74000325|NCT01156792|147548904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.651|||=|0.563|TWO_SIDED|95.0|-3.97|7.27|||Mixed Models Analysis|||||7.27|-3.97|=0.563
74000326|NCT01156792|147548904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||=|0.072|TWO_SIDED|95.0|-0.47|10.67|||Mixed Models Analysis|||||10.67|-0.47|=0.072
74036740|NCT01968954|147626868|SUPERIORITY_OR_OTHER||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|16.55||0.86|TWO_SIDED|95.0|-35.4|29.5|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||29.5|-35.4|0.860
74036741|NCT01968954|147626868|SUPERIORITY_OR_OTHER||LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|25.11|||TWO_SIDED|95.0|-47.2|51.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||51.4|-47.2|
74090688|NCT00922272|147735382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4312||95.0|||||t-test, 2 sided|||||||0.4312
74000327|NCT01156792|147548904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.822|||=|0.126|TWO_SIDED|95.0|-1.37|11.02|||Mixed Models Analysis|||||11.02|-1.37|=0.126
74000328|NCT01156792|147548904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.292|||=|0.001|TWO_SIDED|95.0|4.21|16.38|||Mixed Models Analysis|||||16.38|4.21|=0.001
74000329|NCT01156792|147548905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.154|||||TWO_SIDED|95.0|-9.36|1.06||||||||1.06|-9.36|
74000330|NCT01156792|147548905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.364|||||TWO_SIDED|95.0|-6.22|5.5||||||||5.50|-6.22|
74000331|NCT01156792|147548906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|||=|0.957|TWO_SIDED|95.0|-0.18|0.17|||Mixed Models Analysis|||||0.17|-0.18|=0.957
74000332|NCT01156792|147548906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108|||=|0.213|TWO_SIDED|95.0|-0.28|0.06|||Mixed Models Analysis|||||0.06|-0.28|=0.213
74090689|NCT00922272|147735383|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||0.0874|TWO_SIDED|95.0|-5.4|0.4|||ANCOVA|||||0.4|-5.4|0.0874
74090690|NCT00922272|147735384|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Total Skills||||<0.0001
74090691|NCT00922272|147735384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||t-test, 2 sided|||Communication Skills||||0.0002
74036742|NCT01968954|147626868|SUPERIORITY_OR_OTHER||LS mean difference|12.9|STANDARD_ERROR_OF_MEAN|29.25|||TWO_SIDED|95.0|-44.5|70.4||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||70.4|-44.5|
74036743|NCT01968954|147626869|SUPERIORITY_OR_OTHER||LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|2.4|7.0|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||7.0|2.4|<0.001
74036744|NCT01968954|147626869|SUPERIORITY_OR_OTHER||LS mean difference|6.8|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|4.5|9.1||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||9.1|4.5|
74036745|NCT01968954|147626869|SUPERIORITY_OR_OTHER||LS mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|0.9|5.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||5.8|0.9|
74036746|NCT01968954|147626870|SUPERIORITY_OR_OTHER||LS mean difference|-59.1|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|-63.4|-54.8|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-54.8|-63.4|<0.001
74036747|NCT01968954|147626871|SUPERIORITY_OR_OTHER||LS mean difference|-48.7|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-58.0|-39.3|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-39.3|-58.0|<0.001
74036748|NCT01968954|147626872|SUPERIORITY_OR_OTHER||LS mean difference|-56.0|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-60.8|-51.2||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-51.2|-60.8|
74036749|NCT01968954|147626872|SUPERIORITY_OR_OTHER||LS mean difference|-46.4|STANDARD_ERROR_OF_MEAN|2.77|||TWO_SIDED|95.0|-51.8|-41.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-41.0|-51.8|
74036750|NCT01968954|147626873|SUPERIORITY_OR_OTHER||LS mean difference|-57.6|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-63.1|-52.0||||||TG \<200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-52.0|-63.1|
74036751|NCT01968954|147626873|SUPERIORITY_OR_OTHER||LS mean difference|-47.7|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|95.0|-53.9|-41.5||||||TG \<200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-41.5|-53.9|
74036752|NCT01968954|147626873|SUPERIORITY_OR_OTHER||LS mean difference|-49.3|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|-58.9|-39.8||||||TG \>=200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-39.8|-58.9|
74036753|NCT01968954|147626873|SUPERIORITY_OR_OTHER||LS mean difference|-41.2|STANDARD_ERROR_OF_MEAN|5.6|||TWO_SIDED|95.0|-52.2|-30.1||||||TG \>=200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-30.1|-52.2|
73877261|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-9.0||||0.518|TWO_SIDED|95.0|-36.0|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||17.9|-36.0|0.518
74036754|NCT01968954|147626874|SUPERIORITY_OR_OTHER||LS mean difference|-14.2|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.5|-19.9|
74036755|NCT01968954|147626874|SUPERIORITY_OR_OTHER||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-14.7|-25.1|
74036756|NCT01968954|147626874|SUPERIORITY_OR_OTHER||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-2.8|-15.7|
74036757|NCT01968954|147626875|SUPERIORITY_OR_OTHER||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|1.8|5.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||5.7|1.8|
74036758|NCT01968954|147626875|SUPERIORITY_OR_OTHER||LS mean difference|4.9|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|3.1|6.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||6.7|3.1|
74090692|NCT00922272|147735384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0|||||t-test, 2 sided|||Financial Skills||||0.0028
73877262|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|6.3||||0.695|TWO_SIDED|95.0|-25.1|37.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||37.6|-25.1|0.695
73877263|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|11.4||||0.373|TWO_SIDED|95.0|-13.5|36.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||36.4|-13.5|0.373
74000333|NCT01156792|147548906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|||=|0.647|TWO_SIDED|95.0|-0.2|0.12|||Mixed Models Analysis|||||0.12|-0.20|=0.647
74000334|NCT01156792|147548906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|||=|0.894|TWO_SIDED|95.0|-0.17|0.15|||Mixed Models Analysis|||||0.15|-0.17|=0.894
74000335|NCT01156792|147548907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|||=|0.811|TWO_SIDED|95.0|-0.23|0.18|||Mixed Models Analysis|||||0.18|-0.23|=0.811
74000336|NCT01156792|147548907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|||=|0.2|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|||||0.07|-0.34|=0.200
74000337|NCT01156792|147548907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|||=|0.415|TWO_SIDED|95.0|-0.26|0.11|||Mixed Models Analysis|||||0.11|-0.26|=0.415
74000338|NCT01156792|147548907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||=|0.358|TWO_SIDED|95.0|-0.26|0.1|||Mixed Models Analysis|||||0.10|-0.26|=0.358
74000339|NCT01156792|147548908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.666|||=|0.285|TWO_SIDED|95.0|-2.24|7.57|||Mixed Models Analysis|||||7.57|-2.24|=0.285
74000340|NCT01156792|147548908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|||=|0.035|TWO_SIDED|95.0|0.38|10.22|||Mixed Models Analysis|||||10.22|0.38|=0.035
74000341|NCT01156792|147548908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.036|||=|0.09|TWO_SIDED|95.0|-0.63|8.7|||Mixed Models Analysis|||||8.70|-0.63|=0.090
74000342|NCT01156792|147548908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.602|||=|0.047|TWO_SIDED|95.0|0.06|9.14|||Mixed Models Analysis|||||9.14|0.06|=0.047
74000343|NCT01156792|147548909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.014|||=|0.668|TWO_SIDED|95.0|-3.64|5.67|||Mixed Models Analysis|||||5.67|-3.64|=0.668
74000344|NCT01156792|147548909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.349|||=|0.156|TWO_SIDED|95.0|-1.29|7.98|||Mixed Models Analysis|||||7.98|-1.29|=0.156
74000345|NCT01156792|147548909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.496|||=|0.822|TWO_SIDED|95.0|-3.83|4.82|||Mixed Models Analysis|||||4.82|-3.83|=0.822
74000346|NCT01156792|147548909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||=|0.555|TWO_SIDED|95.0|-2.94|5.46|||Mixed Models Analysis|||||5.46|-2.94|=0.555
74000347|NCT01156792|147548910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.992|||=|0.367|TWO_SIDED|95.0|-2.35|6.33|||Mixed Models Analysis|||||6.33|-2.35|=0.367
74000348|NCT01156792|147548910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.147|||=|0.332|TWO_SIDED|95.0|-2.2|6.49|||Mixed Models Analysis|||||6.49|-2.20|=0.332
74000349|NCT01156792|147548910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.331|||=|0.277|TWO_SIDED|95.0|-1.88|6.55|||Mixed Models Analysis|||||6.55|-1.88|=0.277
74000350|NCT01156792|147548910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.521|||=|0.467|TWO_SIDED|95.0|-2.59|5.63|||Mixed Models Analysis|||||5.63|-2.59|=0.467
74000351|NCT01156792|147548911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.575|||=|0.789|TWO_SIDED|95.0|-3.65|4.8|||Mixed Models Analysis|||||4.80|-3.65|=0.789
74000352|NCT01156792|147548911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.669|||=|0.087|TWO_SIDED|95.0|-0.54|7.87|||Mixed Models Analysis|||||7.87|-0.54|=0.087
74000353|NCT01156792|147548911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.923|TWO_SIDED|95.0|-3.84|4.24|||Mixed Models Analysis|||||4.24|-3.84|=0.923
74000354|NCT01156792|147548911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.137|||=|0.571|TWO_SIDED|95.0|-5.08|2.81|||Mixed Models Analysis|||||2.81|-5.08|=0.571
74000355|NCT01156792|147548912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.014|||=|0.668|TWO_SIDED|95.0|-3.64|5.67|||Mixed Models Analysis|||||5.67|-3.64|=0.668
74000356|NCT01156792|147548912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.349|||=|0.156|TWO_SIDED|95.0|-1.29|7.98|||Mixed Models Analysis|||||7.98|-1.29|=0.156
74000357|NCT01156792|147548912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.496|||=|0.822|TWO_SIDED|95.0|-3.83|4.82|||Mixed Models Analysis|||||4.82|-3.83|=0.822
74000358|NCT01156792|147548912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||=|0.555|TWO_SIDED|95.0|-2.94|5.46|||Mixed Models Analysis|||||5.46|-2.94|=0.555
74000359|NCT01156792|147548913|SUPERIORITY_OR_OTHER||||||=|0.408||95.0|||||Fisher Exact|||||||=0.408
74000360|NCT01156792|147548913|SUPERIORITY_OR_OTHER||||||=|0.138||95.0|||||Fisher Exact|||||||=0.138
74000361|NCT01156792|147548913|SUPERIORITY_OR_OTHER||||||=|0.797||95.0|||||Fisher Exact|||||||=0.797
74000362|NCT01156792|147548913|SUPERIORITY_OR_OTHER||||||=|0.408||95.0|||||Fisher Exact|||||||=0.408
74000363|NCT00952120|147548949|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Regression, Logistic|robust standard errors were used to account for the multiple observations per patient||||||0.80
74000364|NCT00682890|147548978|SUPERIORITY_OR_OTHER|||||||0.63|||||||ANOVA|||P value on change at 3 months for placebo group||||0.63
74000365|NCT00682890|147548978|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||||||0.42
74000366|NCT00682890|147548979|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||||||0.51
74000367|NCT00682890|147548979|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANOVA|||||||0.03
74000368|NCT03028220|147548981|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
74000369|NCT03028220|147548982|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74000370|NCT03028220|147548983|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74000371|NCT03028220|147548984|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
74000372|NCT03028220|147548985|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
74000373|NCT03028220|147548986|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
74000374|NCT03028220|147548987|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
74000375|NCT03028220|147548988|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.570
74000376|NCT03028220|147548989|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74000377|NCT03028220|147548990|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.910
74000378|NCT03028220|147548991|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.460
74000379|NCT03028220|147548992|OTHER|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
74000380|NCT02224690|147548993|SUPERIORITY||Median Difference (Final Values)|-17.21||||0.0135|TWO_SIDED|95.0|-30.32|-4.09|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-4.09|-30.32|0.0135
74000381|NCT02224690|147548994|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0043|TWO_SIDED|95.0|1.33|4.97|||Cochran-Mantel-Haenszel|Calculated using a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)||||4.97|1.33|0.0043
74000382|NCT02224690|147548995|SUPERIORITY||Mean Difference (Final Values)|-21.13||||0.0005|TWO_SIDED|95.0|-33.26|-9.37|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-9.37|-33.26|0.0005
74000383|NCT02224690|147548996|SUPERIORITY||Odds Ratio (OR)|2.54||||0.0012|TWO_SIDED|95.0|1.45|4.47|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor.|Odds of participants recording a lower score (improvement) on a continuous scale|||4.47|1.45|0.0012
74000384|NCT00141219|147548997|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.115||||0.289||95.0|0.785|1.583||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.||1.583|0.785|0.289
74000385|NCT00141219|147548998|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.644||||0.041||95.0|0.915|2.954||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.||2.954|0.915|0.041
74000386|NCT00141219|147548999|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.252||0.049||95.0|-1.0|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from the general linear model with treatment and center fitted as factors and the baseline value as a covariate.||Null hypotheses stated there was no difference in pregabalin and placebo in the primary endpoint versus the alternative that there was. The target sample size was 234 subjects (156 and 78 respectively pregabalin vs placebo using a 2:1 ratio). The calculations assumed a 2-sided comparison at 0.05 alpha, 80% power and 3% dropout. Also, a treatment difference of 1 point and a standard deviation for endpoint mean pain scores of 2.5 were assumed based on previous studies.||-0.00|-1.00|0.049
74000387|NCT00141219|147548999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.729||95.0||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|"In supportive model 1, a treatment by center independent variable added to the main model."||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across centers.||||0.729
74000388|NCT00141219|147548999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.979||95.0||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|"In supportive model 2, a treatment by baseline mean pain independent variable added to the main model."||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across different baseline values.||||0.979
74000389|NCT00141219|147549000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.267||0.077||95.0|-1.0|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center fitted as factors and the baseline value as a covariate.||"Endpoint Mean Pain Score~Pregabalin minus Placebo"||0.05|-1.00|0.077
74000390|NCT00141219|147549001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.186||0.042||95.0|-0.75|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center, and treatment by week interaction as factors and baseline value as a covariate.||"Mean Pain Score Weeks 1 to 8~Overall Comparison (8-week average)~Pregabalin minus Placebo"||-0.01|-0.75|0.042
74008663|NCT01338415|147567427|OTHER|||||||0.0526||||||p-value \<= 10% indicates that the covariate WHO FC at baseline is related to the time to PAH worsening|Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate||||0.0526
74008664|NCT01338415|147567427|OTHER||Hazard Ratio (HR)|1.169||||||95.0|0.371|3.681|||Regression, Cox|||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates||3.681|0.371|
74008665|NCT01338415|147567427|SUPERIORITY|||||||0.076||||||p-value \<= 10% indicates an improvement in model fit|log(e) likelihood ratio|||Test of improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate||||0.076
74008666|NCT01338415|147567428|OTHER||Hazard Ratio (HR)|1.935|||||TWO_SIDED|95.0|0.582|6.428|||Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)||6.428|0.582|
73877264|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-6.9||||0.628|TWO_SIDED|95.0|-34.6|20.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||20.8|-34.6|0.628
73877265|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||0.6|-30.6|1.000
73877266|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-22.4|20.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||20.9|-22.4|1.000
73877267|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||0.6|-30.6|0.251
73877268|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||3.1|-23.1|1.000
73877269|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||17.7|-18.7|1.000
73877270|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||3.1|-23.1|0.501
73877271|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|9.5||||0.488|TWO_SIDED|95.0|-3.0|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||22.1|-3.0|0.488
73877272|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|1.000
73956949|NCT01729819|147449804|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.086||||||Adjusted treatment difference in mean number of nocturnal voids (Combination-tolterodine) at Month 2|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 2||||0.086
73956950|NCT01729819|147449804|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.055||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 3|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 3||||0.055
73956951|NCT01729819|147449804|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.106||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids for the duration of 3 months|ANCOVA|||Treatment difference (Combination-tolterodine) for the duration of 3 months||||0.106
73956952|NCT01729819|147449805|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.178|TWO_SIDED|95.0|-0.2|1.05|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented.Statistical analysis for from very tired to wide awake, how do you feel now"||1.05|-0.20|0.178
73956953|NCT01729819|147449805|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.257|TWO_SIDED|95.0|-0.26|0.94|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate how refreshed you feel now"||0.94|-0.26|0.257
73956954|NCT01729819|147449805|SUPERIORITY|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Mean Difference (Final Values)|0.28||||0.36|TWO_SIDED|95.0|-0.32|0.88|||ANCOVA|Longitudinal analysis of covariance on change from baseline with baseline as a covariate, and treatment and visit as factors.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate the quality of your sleep last night"||0.88|-0.32|0.360
73956955|NCT03686813|147449829|OTHER|||||||0.317|||||||McNemar|||||||0.317
73956956|NCT03686813|147449830|OTHER|||||||0.317|||||||McNemar|||||||0.317
73956957|NCT03686813|147449831|OTHER||||||>|0.999|||||||McNemar|||||||>0.999
73956958|NCT03686813|147449832|OTHER|||||||0.18|||||||McNemar|||||||0.18
74036759|NCT01968954|147626875|SUPERIORITY_OR_OTHER||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|0.7|4.6||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||4.6|0.7|
74036760|NCT01968954|147626876|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-1.9|1.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||1.7|-1.9|
74036761|NCT01968954|147626876|SUPERIORITY_OR_OTHER||LS mean difference|1.9|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-0.1|3.9||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.9|-0.1|
74036762|NCT01968954|147626876|SUPERIORITY_OR_OTHER||LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-1.0|3.1||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.1|-1.0|
74036763|NCT01968954|147626877|SUPERIORITY_OR_OTHER||LS-Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.5|-19.9|
74036764|NCT01968954|147626877|SUPERIORITY_OR_OTHER||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-14.7|-25.1|
74036765|NCT01968954|147626877|SUPERIORITY_OR_OTHER||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-2.8|-15.7|
74036766|NCT01968954|147626878|SUPERIORITY_OR_OTHER||LS mean difference|-64.2|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|95.0|-69.1|-59.2||||||TG \<200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-59.2|-69.1|
74036767|NCT01968954|147626878|SUPERIORITY_OR_OTHER||LS mean difference|-59.6|STANDARD_ERROR_OF_MEAN|5.99|||TWO_SIDED|95.0|-71.4|-47.7||||||TG \>=200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-47.7|-71.4|
74036768|NCT01968954|147626879|SUPERIORITY_OR_OTHER||LS mean difference|-63.4|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|-68.0|-58.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-58.8|-68.0|
74036769|NCT01968954|147626880|SUPERIORITY_OR_OTHER||LS mean difference|-67.1|STANDARD_ERROR_OF_MEAN|2.59|||TWO_SIDED|95.0|-72.2|-62.1||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-62.1|-72.2|
74036770|NCT01968954|147626881|SUPERIORITY_OR_OTHER||LS mean difference|-69.7|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-74.7|-64.6||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-64.6|-74.7|
74036771|NCT01968954|147626882|SUPERIORITY_OR_OTHER||LS mean difference|-47.3|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-50.7|-43.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-43.8|-50.7|
74036772|NCT01968954|147626883|SUPERIORITY_OR_OTHER||LS mean difference|-10.6|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-12.9|-8.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.3|-12.9|
74036773|NCT01968954|147626884|SUPERIORITY_OR_OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|1.4|3.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.5|1.4|
74036774|NCT01968954|147626885|SUPERIORITY_OR_OTHER||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-1.7|-1.4||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.4|-1.7|
74036775|NCT01968954|147626885|SUPERIORITY_OR_OTHER||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-1.7|-1.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.4|-1.7|
74036776|NCT01968954|147626885|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-1.4|-1.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.0|-1.4|
73956959|NCT03686813|147449833|OTHER|||||||0.29|||||||McNemar|||||||0.29
73877273|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-10.0||||0.232|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|0.232
73956960|NCT00920686|147449834|SUPERIORITY_OR_OTHER|||||||0.6407|||||||Log Rank|||||||0.6407
73956961|NCT01444287|147449869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.636|STANDARD_ERROR_OF_MEAN|0.2093||0.0035||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.0035
73956962|NCT01444287|147449869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.743|STANDARD_ERROR_OF_MEAN|0.2093||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control - Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0000
73956963|NCT01444287|147449869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0275|STANDARD_ERROR_OF_MEAN|0.2093||0.8957||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.8957
73956964|NCT01444287|147449870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0057|STANDARD_ERROR_OF_MEAN|0.0031||0.0692||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.0692
73956965|NCT01444287|147449870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0011|STANDARD_ERROR_OF_MEAN|0.0032||0.7301||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.7301
73956966|NCT01444287|147449870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0008|STANDARD_ERROR_OF_MEAN|0.0032||0.8055||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.8055
73956967|NCT01444287|147449871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0122|STANDARD_ERROR_OF_MEAN|0.1111||0.9127||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.9127
73956968|NCT01444287|147449871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6864|STANDARD_ERROR_OF_MEAN|0.1098||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0000
73956969|NCT01444287|147449871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1705|STANDARD_ERROR_OF_MEAN|0.1098||0.1256||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.1256
73956970|NCT01444287|147449872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0688|STANDARD_ERROR_OF_MEAN|5.044||0.9892||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.9892
73956971|NCT01444287|147449872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|4.984||0.0007||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0007
73956972|NCT01444287|147449872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.37|STANDARD_ERROR_OF_MEAN|4.984||0.003||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.0030
73956973|NCT01456936|147449894|SUPERIORITY_OR_OTHER|||||||0.0652||||||An interaction between treatment and cohort was considered significant at 10% level. No multiplicity adjustments were utilized.|Regression, Linear|A generalized linear regression analysis based on the safety analysis set was used to evaluate incidence of NPS AE as the primary analysis.||The reduced (final) statistical model included treatment group, cohort and region, plus the 2-way interaction of treatment by cohort. Other interactions not included due to lack of significance. Region reduced to 2-level to address event sparseness issue.||||0.0652
73956974|NCT01456936|147449895|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.28|||||TWO_SIDED|95.0|-2.4|-0.15|||Regression, Linear||Risk difference for varenicline versus placebo from estimation model.|Non-psychiatric cohort||-0.15|-2.40|
73956975|NCT01456936|147449895|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08|||||TWO_SIDED|95.0|-1.37|1.21|||Regression, Linear||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Non-psychiatric cohort||1.21|-1.37|
73956976|NCT01456936|147449895|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21|||||TWO_SIDED|95.0|-1.54|1.12|||Regression, Linear||Risk difference for NRT versus placebo from estimation model.|Non-psychiatric cohort||1.12|-1.54|
73956977|NCT01456936|147449895|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.59|||||TWO_SIDED|95.0|-0.42|3.59|||Regression, Linear||Risk difference for varenicline versus placebo from estimation model|Psychiatric cohort||3.59|-0.42|
73956978|NCT01456936|147449895|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.78|||||TWO_SIDED|95.0|-0.24|3.81|||Regression, Linear||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Psychiatric cohort||3.81|-0.24|
73956979|NCT01456936|147449895|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.37|||||TWO_SIDED|95.0|-1.53|2.26|||Regression, Linear||Risk difference for NRT versus placebo from estimation model.|Psychiatric cohort||2.26|-1.53|
73956980|NCT01456936|147449910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.0001|TWO_SIDED|95.0|3.2|5.0||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||5.00|3.20|<0.0001
73956981|NCT01456936|147449910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|||<|0.0001|TWO_SIDED|95.0|1.8|2.85||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.85|1.80|<0.0001
74090693|NCT00922272|147735385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4637|TWO_SIDED|95.0|-5.3|2.4|||ANCOVA|||Total Skills||2.4|-5.3|0.4637
73877274|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|0.501
73877275|NCT02365649|147294860|SUPERIORITY||Risk Difference (RD)|9.5||||0.488|TWO_SIDED|95.0|-3.0|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||22.1|-3.0|0.488
73877276|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|20.0||||0.295|TWO_SIDED|95.0|2.5|37.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||37.5|2.5|0.295
73877277|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|13.8||||0.355|TWO_SIDED|95.0|-7.4|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||34.9|-7.4|0.355
73877278|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-20.0||||0.384|TWO_SIDED|95.0|-55.1|15.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||15.1|-55.1|0.384
73877279|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-22.5||||0.311|TWO_SIDED|95.0|-59.5|14.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||14.5|-59.5|0.311
73877280|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-16.3||||0.422|TWO_SIDED|95.0|-43.8|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||11.3|-43.8|0.422
73877281|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-25.0||||0.181|TWO_SIDED|95.0|-59.2|9.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||9.2|-59.2|0.181
73877282|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||44.0|6.0|0.281
73877283|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||28.5|-28.5|1.000
74000391|NCT00141219|147549001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.071||95.0|-0.79|0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Mean Pain Score~Pregabalin minus Placebo"||0.03|-0.79|0.071
73877284|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-25.0||||0.231|TWO_SIDED|95.0|-61.3|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||11.3|-61.3|0.231
73877285|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|27.5||||0.214|TWO_SIDED|95.0|-3.9|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||58.9|-3.9|0.214
73877286|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|21.3||||0.277|TWO_SIDED|95.0|-7.5|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||50.0|-7.5|0.277
74000392|NCT00141219|147549001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.212||0.149||95.0|-0.72|0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Mean Pain Score~Pregabalin minus Placebo"||0.11|-0.72|0.149
74000393|NCT00141219|147549001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.213||0.057||95.0|-0.82|0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Mean Pain Score~Pregabalin minus Placebo"||0.01|-0.82|0.057
74090694|NCT00922272|147735385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.6137|TWO_SIDED|95.0|-4.1|2.4|||ANCOVA|||Communication Skills||2.4|-4.1|0.6137
73877287|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-20.0||||0.442|TWO_SIDED|95.0|-57.2|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||17.2|-57.2|0.442
73956982|NCT01456936|147449910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.83|2.9||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.90|1.83|<0.0001
73956983|NCT01456936|147449911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.0001|TWO_SIDED|95.0|2.56|4.11||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||4.11|2.56|<0.0001
73956984|NCT01456936|147449911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87|||<|0.0001|TWO_SIDED|95.0|1.46|2.39||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.39|1.46|<0.0001
73956985|NCT01456936|147449911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001|TWO_SIDED|95.0|1.56|2.55||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.55|1.56|<0.0001
73956986|NCT01456936|147449912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.61|||<|0.0001|TWO_SIDED|95.0|3.07|4.24||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||4.24|3.07|<0.0001
74000394|NCT00141219|147549001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.215||0.044||95.0|-0.85|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Mean Pain Score~Pregabalin minus Placebo"||-0.01|-0.85|0.044
73956987|NCT01456936|147449912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07|||<|0.0001|TWO_SIDED|95.0|1.75|2.45||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.45|1.75|<0.0001
73956988|NCT01456936|147449912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15|||<|0.0001|TWO_SIDED|95.0|1.82|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.54|1.82|<0.0001
73956989|NCT01456936|147449913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99|||<|0.0001|TWO_SIDED|95.0|2.33|3.83||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||3.83|2.33|<0.0001
73956990|NCT01456936|147449913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001|TWO_SIDED|95.0|1.54|2.59||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.59|1.54|<0.0001
73956991|NCT01456936|147449913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.51|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.54|1.51|<0.0001
73956992|NCT01456936|147449914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.9|3.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||3.29|1.90|<0.0001
73956993|NCT01456936|147449914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77|||<|0.0001|TWO_SIDED|95.0|1.33|2.36||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.36|1.33|<0.0001
73956994|NCT01456936|147449914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|||<|0.0001|TWO_SIDED|95.0|1.24|2.2||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.20|1.24|<0.0001
73956995|NCT01456936|147449915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74|||<|0.0001|TWO_SIDED|95.0|2.28|3.3||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||3.30|2.28|<0.0001
74090695|NCT00922272|147735385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.3482|TWO_SIDED|95.0|-3.5|1.3|||ANCOVA|||Financial Skills||1.3|-3.5|0.3482
74090696|NCT00922272|147735386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0174||95.0|||||t-test, 2 sided|||Global Executive Composite||||0.0174
74090697|NCT00922272|147735386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0461||95.0|||||t-test, 2 sided|||Behavioral Recognition Index||||0.0461
74090698|NCT00922272|147735386|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146||95.0|||||t-test, 2 sided|||Metacognition Index||||0.0146
74090699|NCT00922272|147735387|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.7418|TWO_SIDED|95.0|-3.8|2.7|||ANCOVA|||Global Executive Composite||2.7|-3.8|0.7418
74036777|NCT01968954|147626886|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.3|-0.4|
73877288|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|20.0||||0.419|TWO_SIDED|95.0|-17.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||57.1|-17.1|0.419
73877289|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|20.0||||0.214|TWO_SIDED|95.0|-10.4|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||50.4|-10.4|0.214
73877290|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-15.0||||0.439|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||22.4|-52.4|0.439
73877291|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|23.1||||0.284|TWO_SIDED|95.0|-10.1|56.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||56.4|-10.1|0.284
73877292|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|0.2||||0.988|TWO_SIDED|95.0|-23.9|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||24.3|-23.9|0.988
73877293|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-12.1||||0.37|TWO_SIDED|95.0|-38.1|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||13.9|-38.1|0.370
74036778|NCT01968954|147626886|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.3|-0.4|
74036779|NCT01968954|147626886|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.3|-0.2||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.2|-0.3|
74036780|NCT01968954|147626887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.0|||||TWO_SIDED|95.0|13.86|41.64||||||Week 12||41.64|13.86|
73877294|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|25.6||||0.268|TWO_SIDED|95.0|-8.9|60.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||60.2|-8.9|0.268
73877295|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-5.0||||0.665|TWO_SIDED|95.0|-27.4|17.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||17.5|-27.4|0.665
73877296|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-3.9||||0.759|TWO_SIDED|95.0|-28.9|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||21.0|-28.9|0.759
73877297|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|21.9||||0.259|TWO_SIDED|95.0|-12.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||56.6|-12.8|0.259
74036781|NCT01968954|147626887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8|||||TWO_SIDED|95.0|9.32|23.56||||||Week 24||23.56|9.32|
74036782|NCT01968954|147626887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.8|||||TWO_SIDED|95.0|6.36|15.24||||||Week 52||15.24|6.36|
74036783|NCT01968954|147626888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|95.2|||||TWO_SIDED|95.0|52.09|173.91||||||Week 12||173.91|52.09|
74036784|NCT01968954|147626888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|112.2|||||TWO_SIDED|95.0|55.81|225.52||||||Week 24||225.52|55.81|
74036785|NCT01968954|147626888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|29.1|||||TWO_SIDED|95.0|17.13|49.49||||||Week 52||49.49|17.13|
74090700|NCT00922272|147735387|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.6429|TWO_SIDED|95.0|-2.6|4.1|||ANCOVA|||Behavioral Recognition Index||4.1|-2.6|0.6429
74090701|NCT00922272|147735387|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4364|TWO_SIDED|95.0|-4.8|2.1|||ANCOVA|||Metacognition Index||2.1|-4.8|0.4364
74090702|NCT02588950|147735398|SUPERIORITY||Geometric LSMean Ratio|1.46|||||TWO_SIDED|90.0|1.08|1.97|||Mixed Models Analysis|||||1.97|1.08|
74090703|NCT02588950|147735402|SUPERIORITY||Geometric LSMean Ratio|0.885|||||TWO_SIDED|90.0|0.761|1.03|||Mixed Models Analysis|||||1.03|0.761|
74090704|NCT02588950|147735403|SUPERIORITY||Median Difference (Final Values)|0.9|||||TWO_SIDED|90.0|-1.6|2.6||||||||2.60|-1.60|
74000395|NCT00141219|147549001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.216||0.051||95.0|-0.85|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Mean Pain Score~Pregabalin minus Placebo"||0.00|-0.85|0.051
74000396|NCT00141219|147549001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.216||0.178||95.0|-0.72|0.13||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Mean Pain Score~Pregabalin minus Placebo"||0.13|-0.72|0.178
74000397|NCT00141219|147549001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.218||0.104||95.0|-0.78|0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Mean Pain Score~Pregabalin minus Placebo"||0.07|-0.78|0.104
74000398|NCT00141219|147549001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.218||0.039||95.0|-0.88|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Mean Pain Score~Pregabalin minus Placebo"||-0.02|-0.88|0.039
74000399|NCT00141219|147549002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.186||0.044||95.0|-0.74|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Duration Adjusted Average Change (DAAC)~Pregabalin minus Placebo"||-0.01|-0.74|0.044
74000400|NCT00141219|147549003|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.272||0.018||95.0|-1.19|-0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Sleep Interference Score~Pregabalin minus Placebo"||-0.11|-1.19|0.018
74000401|NCT00141219|147549004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.226||0.024||95.0|-0.96|-0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Weeks 1 to 8 Mean Sleep Score~Overall Comparison (8-week average)~Pregabalin minus Placebo"||-0.07|-0.96|0.024
74000402|NCT00141219|147549004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.245||0.12||95.0|-0.86|0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Sleep Interference Score~Pregabalin minus Placebo"||0.10|-0.86|0.120
74000403|NCT00141219|147549004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.246||0.041||95.0|-0.99|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Sleep Interference Score~Pregabalin minus Placebo"||-0.02|-0.99|0.041
74000404|NCT00141219|147549004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.248||0.017||95.0|-1.07|-0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Sleep Interference Score~Pregabalin minus Placebo"||-0.10|-1.07|0.017
74000405|NCT00141219|147549004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.249||0.033||95.0|-1.02|-0.04||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Sleep Interference Score~Pregabalin minus Placebo"||-0.04|-1.02|0.033
74000406|NCT00141219|147549004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.25||0.078||95.0|-0.93|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Sleep Interference Score~Pregabalin minus Placebo"||0.05|-0.93|0.078
74000407|NCT00141219|147549004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.25||0.038||95.0|-1.01|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Sleep Interference Score~Pregabalin minus Placebo"||-0.03|-1.01|0.038
74008667|NCT01338415|147567428|OTHER|||||||0.0085|||||||Regression, Cox|p-value \<= 10% indicates that the covariate is related to the time to the time to death up to end-of-study||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate||||0.0085
73877298|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||19.9|-23.2|0.880
73877299|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||11.2|-32.7|0.355
73956996|NCT01456936|147449915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89|||<|0.0001|TWO_SIDED|95.0|1.56|2.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.29|1.56|<0.0001
73956997|NCT01456936|147449915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.49|2.19||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.19|1.49|<0.0001
73956998|NCT01710514|147449921|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative (Ha) by constructing two-sided 95%CI for the difference. The non-inferiority limit for the difference was pre-specified to -10.0% (absolute). If the lower limit of the two-sided 95%CI was greater than the non-inferiority limit (-10.0%) for both the FAS and per protocol set, the null hypothesis was to be rejected. In that case it would be claimed that the rate observed in this trial was non-inferior to the rate observed in the CS08 trial|Difference of % to historical control|-0.9|||||TWO_SIDED|95.0|-3.6|1.8||||||To verify sufficient supplementation of luteal hormone, the proportion of subjects with blood progesterone concentration ≥ 10 ng/mL on Day 5 was compared to the result from a historical control, trial CS08 (NCT number: 00884221). The corresponding proportion of subjects in trial CS08 was 99.8% (95%CI: 99.1;100.0, 631/632 subjects). The non-inferiority hypothesis tested for this primary endpoint was: H0: P(000072)-P(CS08) ≤ -10.0% against the alternative Ha: P(000072)-P(CS08) \> -10.0%.||1.8|-3.6|
74008668|NCT01338415|147567428|OTHER||Hazard Ratio (HR)|1.487|||||TWO_SIDED|95.0|0.437|5.052|||Regression, Cox|||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates||5.052|0.437|
74008669|NCT01338415|147567428|SUPERIORITY|||||||0.014|||||||log(e) likelihood ratio|p-value \<= 10% indicates an improvement in model fit||Test of the improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate||||0.014
74008670|NCT05215262|147567446|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.04|TWO_SIDED|95.0|0.04|3.17|||Mixed Models Analysis|||||3.17|0.04|0.04
73956999|NCT02020018|147449926|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
73957000|NCT00667693|147449929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.23|0.55|||Regression, Cox|||||0.55|0.23|<0.001
73957001|NCT04044664|147449934|OTHER|||||||0.1728|||||||t-test, 1 sided|||CAPS-5 Total Score||||0.1728
73957002|NCT04044664|147449934|OTHER|||||||0.0962|||||||t-test, 1 sided|||Cognition and Mood sub-score||||0.0962
73957003|NCT04044664|147449934|OTHER|||||||0.0191|||||||t-test, 1 sided|||Arousal and Reactivity sub-score||||0.0191
73957004|NCT04044664|147449940|OTHER|||||||0.0452|||||||t-test, 1 sided|||||||0.0452
73957005|NCT04044664|147449940|OTHER|||||||0.0614|||||||t-test, 1 sided|||||||0.0614
73957006|NCT04044664|147449941|OTHER|||||||0.0182|||||||t-test, 1 sided|||greater than or equal to 30% decrease from baseline||||0.0182
73957007|NCT04044664|147449941|OTHER|||||||0.0705|||||||t-test, 1 sided|||greater than or equal to 50% decrease from baseline||||0.0705
73957008|NCT00300456|147449953|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
73957009|NCT00300456|147449953|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
73957010|NCT00300456|147449954|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
73957011|NCT00300456|147449954|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
73957012|NCT00300456|147449955|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
73957013|NCT00300456|147449955|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
74000408|NCT00141219|147549004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.252||0.037||95.0|-1.02|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Sleep Interference Score~Pregabalin minus Placebo"||-0.03|-1.02|0.037
74000409|NCT00141219|147549004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.252||0.015||95.0|-1.11|-0.12||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Sleep Interference Score~Pregabalin minus Placebo"||-0.12|-1.11|0.015
74000410|NCT00141219|147549005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.62|STANDARD_ERROR_OF_MEAN|2.639||0.034||95.0|-10.82|-0.42||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Disturbance~Pregabalin minus Placebo"||-0.42|-10.82|0.034
74000411|NCT00141219|147549006|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.05|STANDARD_ERROR_OF_MEAN|3.309||0.128||95.0|-1.47|11.58||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Snoring Score~Pregabalin minus Placebo"||11.58|-1.47|0.128
74000412|NCT00141219|147549007|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|1.887||0.103||95.0|-6.81|0.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Awaken Short of Breath or Headache~Pregabalin minus Placebo"||0.63|-6.81|0.103
74000413|NCT00141219|147549008|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.182||0.018||95.0|0.08|0.8||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Quantity~Pregabalin minus Placebo"||0.80|0.08|0.018
74000414|NCT00141219|147549009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23|STANDARD_ERROR_OF_MEAN|0.37||0.504||95.0|0.67|2.24||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Regression, Logistic|OR estimated from model with Optimal sleep status (Yes/No) as response variable, and treatment, baseline Optimal sleep status as explanatory variables|"The OR estimates ratio of Odds of optimal sleep between Pregabalin and Placebo (ie, the former to the latter). Odds of optimal sleep in treatment group is ratio of Probability of having optimal sleep vs Probability of Not having optimal sleep"|"Week 8 Optimal Sleep~Optimal Sleep is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.~Odds ratio measured the odds of optimal sleep in pregabalin to that in placebo.~Standard Error of the Mean equals Standard Error of the Odds Ratio (OR)."||2.24|0.67|.504
74000415|NCT00141219|147549010|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.796||0.571||95.0|-5.33|9.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Adequacy~Pregabalin minus Placebo"||9.63|-5.33|0.571
74000416|NCT00141219|147549011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|2.349||0.046||95.0|0.08|9.34||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Somnolence~Pregabalin minus Placebo"||9.34|0.08|0.046
74000417|NCT00141219|147549012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.12|STANDARD_ERROR_OF_MEAN|2.044||0.3||95.0|-6.15|1.91||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Overall Sleep Problem~Pregabalin minus Placebo"||1.91|-6.15|0.300
74000418|NCT00141219|147549013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.0325||0.429||95.0|-0.038|0.09||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Utility Score~Pregabalin minus Placebo"||0.090|-0.038|0.429
74000419|NCT00141219|147549014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|2.375||0.142||95.0|-1.18|8.18||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint VAS Score~Pregabalin minus Placebo"||8.18|-1.18|0.142
74000420|NCT00141219|147549015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.409||0.038||95.0|-1.66|-0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Anxiety Score~Pregabalin minus Placebo"||-0.05|-1.66|0.038
74008671|NCT05215262|147567446|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.82|TWO_SIDED|95.0|-1.59|1.99|||Mixed Models Analysis|||||1.99|-1.59|0.82
74008672|NCT05215262|147567446|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.2|TWO_SIDED|95.0|-0.89|4.23|||Mixed Models Analysis|||Difference-in-differences results, comparing GSES scores between the Intervention and Standard of Care groups at the three-month time point.||4.23|-0.89|0.20
74000421|NCT00141219|147549016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.438||0.664||95.0|-1.05|0.67||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Depression Score~Pregabalin minus Placebo"||0.67|-1.05|0.664
73877300|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-27.1|37.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||37.1|-27.1|1.000
74000422|NCT00141219|147549017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.473||95.0||||All statistical testing was 2-sided and was conducted at the 5% level of significance. p-value is from comparing Pregabalin versus Placebo.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.||||0.473
74000423|NCT00141219|147549018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119||95.0||||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.||||0.119
74000424|NCT00122460|147549022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.036|TWO_SIDED|95.0|0.644|0.986|||Stratified Log Rank|||"The primary analysis tested the equality of OS between treatment groups applying a 2-sided stratified log-rank test (α=5%), taking into account the strata used for randomization (previous chemotherapy (CTX) \[no vs. yes\] and Karnofsky Performance Status (KPS) \[\<80 vs. ≥80\]).~Median overall survival was estimated using the Kaplan-Meier method. The Hazard Ratio (HR) of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.986|0.644|0.036
74000425|NCT00122460|147549023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.538|||<|0.0001|TWO_SIDED|95.0|0.431|0.672|||Stratified Log Rank|||"To test the equality of PFS between treatment groups, a two-sided stratified log-rank test (α=5%)was used, taking into account strata used for randomization (previous CTX \[yes/no\] and KPS \[\<80 vs. ≥80\]).~Median PFS time was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.672|0.431|<0.0001
74000426|NCT00122460|147549024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.326||||0.0001|TWO_SIDED|95.0|1.504|3.6|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.||3.600|1.504|0.0001
74000427|NCT00122460|147549025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.881|||<|0.0001|TWO_SIDED|95.0|1.87|4.441|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.||4.441|1.870|<0.0001
74000428|NCT00122460|147549026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.593|||<|0.0001|TWO_SIDED|95.0|0.484|0.727|||Stratified Log Rank|||"Treatment groups were compared applying a two-sided stratified log-rank test (α=5%), taking into account strata used for randomization (previous CTX \[yes/no\] and KPS \[\<80 vs. ≥80\]).~Median time to treatment failure was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.727|0.484|<0.0001
74000429|NCT00122460|147549027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.762||||0.21|TWO_SIDED|95.0|0.497|1.168|||Stratified Log Rank|||"To test the equality of duration of response between treatment groups, the two-sided stratified log-rank test (α=5%) was used taking strata used for randomization into account (previous CTX \[no vs. yes\] and KPS \[\<80 vs. ≥80\]).~Median duration of response was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||1.168|0.497|0.21
74000430|NCT02595073|147549031|SUPERIORITY|||||||0.3353|||||||z-test, 2-tailed|||||||0.3353
74000431|NCT02595073|147549032|SUPERIORITY|||||||0.619|||||||ANCOVA|||||||0.6190
74000432|NCT01451827|147549054|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0127|TWO_SIDED|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.00|0.96|0.0127
74000433|NCT01451827|147549054|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97||||0.0108|TWO_SIDED|95.0|0.95|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||0.99|0.95|0.0108
74000434|NCT01451827|147549054|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0155|TWO_SIDED|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.00|0.96|0.0155
74000435|NCT01451827|147549054|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.99||||0.2417|TWO_SIDED|95.0|0.97|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.01|0.97|0.2417
74000436|NCT01451827|147549055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.0002|TWO_SIDED|95.0|0.31|0.99|||ANCOVA|||Urinary Frequency||0.99|0.31|0.0002
74008673|NCT00718549|147567460|SUPERIORITY|||||||0.028|||||||Log Rank|||||||0.028
73877301|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|4.4||||0.688|TWO_SIDED|95.0|-17.0|25.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||25.9|-17.0|0.688
74000437|NCT01451827|147549055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.4|1.08|||ANCOVA|||Urinary Frequency||1.08|0.40|< 0.0001
74000438|NCT01451827|147549055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||<|0.0001|TWO_SIDED|95.0|0.58|1.25|||ANCOVA|||Urinary Frequency||1.25|0.58|< 0.0001
74000439|NCT01451827|147549055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.0004|TWO_SIDED|95.0|0.3|1.01|||ANCOVA|||Urinary Urgency||1.01|0.30|0.0004
74000440|NCT01451827|147549055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.0004|TWO_SIDED|95.0|0.29|1.01|||ANCOVA|||Urinary Urgency||1.01|0.29|0.0004
74000441|NCT01451827|147549055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||<|0.0001|TWO_SIDED|95.0|0.63|1.34|||ANCOVA|||Urinary Urgency||1.34|0.63|< 0.0001
74000442|NCT01451827|147549055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.0002|TWO_SIDED|95.0|0.42|1.3|||ANCOVA|||Nocturia||1.30|0.42|0.0002
74000443|NCT01451827|147549055|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.07|||<|0.0001|TWO_SIDED|95.0|0.63|1.51|||ANCOVA|||Nocturia||1.51|0.63|< 0.0001
74000444|NCT01451827|147549055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.0001|TWO_SIDED|95.0|0.8|1.66|||ANCOVA|||Nocturia||1.66|0.80|< 0.0001
74000445|NCT01451827|147549056|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97||||0.0209|TWO_SIDED|95.0|0.94|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||0.99|0.94|0.0209
74000446|NCT01451827|147549056|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.96||||0.0287|TWO_SIDED|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.00|0.93|0.0287
73877302|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|1.1||||0.927|TWO_SIDED|95.0|-22.3|24.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||24.5|-22.3|0.927
74000447|NCT01451827|147549056|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.96||||0.0298|TWO_SIDED|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.00|0.93|0.0298
74000448|NCT01451827|147549056|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.2306|TWO_SIDED|95.0|0.94|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.01|0.94|0.2306
74000449|NCT01642251|147549064|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|80.0|0.22|0.51||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients within the male/abnormal LDH stratum||0.51|0.22|<0.001
74000450|NCT01642251|147549064|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.18|TWO_SIDED|80.0|0.6|1.09||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients not in the male/abnormal LDH stratum.||1.09|0.60|0.18
74000451|NCT01642251|147549064|SUPERIORITY|||||||0.028||||||p value for the interaction by treatment and stratification factor|Regression, Cox|||If there was a significant treatment-by-stratification factor interaction, the results would be reported separately for each stratum. Significance was defined as the p value was less than 0.05.||||0.028
74000452|NCT01642251|147549065|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.17|TWO_SIDED|80.0|0.64|1.07|||Regression, Cox|stratified on the stratification factors used for randomization||||1.07|0.64|0.17
74000453|NCT01642251|147549067|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
74000454|NCT04493502|147549085|SUPERIORITY||Mean Difference (Final Values)|17.1||||0.189|TWO_SIDED|95.0|-7.3|41.4|||Regression, Logistic|||||41.4|-7.3|0.189
74000455|NCT04493502|147549086|SUPERIORITY||Mean Difference (Final Values)|-4.67||||0.024|TWO_SIDED|95.0|-8.69|-0.64|||ANCOVA|||||-0.64|-8.69|0.024
74000456|NCT04493502|147549087|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.949|TWO_SIDED|95.0|-1.44|1.53|||ANCOVA|||||1.53|-1.44|0.949
74000457|NCT02891837|147549090|OTHER|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||||||0.4930
74000458|NCT02891837|147549092|OTHER|||||||0.1924|||||||Wilcoxon (Mann-Whitney)|||||||0.1924
74000459|NCT02891837|147549093|OTHER|||||||0.8678|||||||Wilcoxon (Mann-Whitney)|||||||0.8678
74000460|NCT02891837|147549100|OTHER|||||||0.6422|||||||Wilcoxon (Mann-Whitney)|||||||0.6422
74000461|NCT02891837|147549101|OTHER|||||||0.7572|||||||Wilcoxon (Mann-Whitney)|||||||0.7572
74000462|NCT02891837|147549103|OTHER|||||||0.3681|||||||Wilcoxon (Mann-Whitney)|||||||0.3681
74008674|NCT00718549|147567460|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.033||95.0|0.187|0.933|||Cox's proportional hazards regression|||Univariate comparison||0.933|0.187|0.033
74008675|NCT00718549|147567460|SUPERIORITY||Hazard Ratio (HR)|0.052||||0.111|TWO_SIDED|95.0|0.001|1.972|||Cox's proportional hazards model|||Multivariate Comparison||1.972|0.001|0.111
74008676|NCT00718549|147567461|SUPERIORITY||Odds Ratio (OR)|3.654||||0.155|TWO_SIDED|95.0|0.674|28.337|||Regression, Logistic|||Week 129: Univariate Comparison||28.337|0.674|0.155
74008677|NCT00718549|147567462|SUPERIORITY||Odds Ratio (OR)|0.625||||0.634|TWO_SIDED|95.0|0.073|4.114|||Regression, Logistic|||Week 129: Univariate comparison||4.114|0.073|0.634
74000463|NCT02891837|147549107|OTHER|"Sample size calculated with nQuery 7.0. Assumed standard deviation = 50 h, \& mean values of 44 h (placebo) \& 14 h (L-citrulline group), estimated effect size = 0.600, yielding a sample size N=92/group (two-sided Wilcoxon-rank-sum test with 0.01 significance level and 90% power). Assumptions for standard deviation \& mean based on Study CIT-002-01 results.~To allow for subjects being enrolled but not assigned to the full analysis set (FAS), an overall N=95 subjects per group were to be enrolled."|Location shift|219.0||||0.156|TWO_SIDED|95.0|-88.0|626.0||The threshold for statistical significance was p = 0.05|Wilcoxon (Mann-Whitney)||Treatment difference = L-citrulline - placebo For the mean and median values, that the estimated values are given in minutes \[min\]|H0: Composite endpoint in L-citrulline group = placebo group H1: Composite endpoint in L-citrulline group ≠ placebo group H0 tested using Wilcoxon-rank-sum test. Significance level = 1% (2-sided).||626.0|-88.0|0.1560
74000464|NCT02891837|147549107|OTHER||Location shift|813.1||||0.1627|TWO_SIDED|95.0|-335.5|1961.6||The threshold for statistical significance was 0.05.|t-test, 2 sided|The results of the T-test should be interpreted with caution since the endpoint is not normally distributed.|Treatment difference = L-citrulline - placebo. For the mean and median values, the estimated values are given in minutes|Post hoc analyses were done for US patients on mechanical ventilation for \<=48 hours. For all post hoc analyses a significance level of 5% was applied.||1961.6|-335.5|0.1627
74000465|NCT02891837|147549115|OTHER|||||||0.0326||||||The threshold for statistical significance was 0.05.|ANOVA|||"Values at 48 hours post-surgery start for all US patients on ventilation for ≤48 hours are presented.~Treatment group, baseline values and site were included as fixed factors, site\*treatment as interaction terms in this ANOVA. The normality assumption of residuals is critical for all considered timepoints. Please interpret results with caution."||||0.0326
74000466|NCT02891837|147549115|OTHER|||||||0.0026||||||The threshold for statistical significance was 0.05.|ANOVA|||"Values at 48 hours post-surgery start for ALL patients on ventilation for ≤48 hours are presented.~Treatment group, baseline values and site were included as fixed factors, site\*treatment as interaction terms in this ANOVA. The normality assumption of residuals is critical for all considered timepoints. Please interpret results with caution."||||0.0026
74000467|NCT02632526|147549127|SUPERIORITY_OR_OTHER||Slope|1.24|STANDARD_ERROR_OF_MEAN|0.0433|||TWO_SIDED|90.0|1.17|1.31||||||||1.31|1.17|
74000468|NCT02632526|147549127|SUPERIORITY_OR_OTHER||Slope|0.322|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|90.0|-0.0124|0.656||||||||0.656|-0.0124|
74000469|NCT02632526|147549128|SUPERIORITY_OR_OTHER||Slope|1.22|STANDARD_ERROR_OF_MEAN|0.0813|||TWO_SIDED|90.0|1.08|1.36||||||Day 1||1.36|1.08|
74036786|NCT00751114|147626901|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.77|-0.42||An analysis of covariance (ANCOVA) was performed, with the HbA1c change from baseline to last on-treatment measurement as dependent variable, treatment as fixed effect and the corresponding baseline HbA1c value as covariate|ANCOVA||Difference (Insulin glargine - Sitagliptin)|"H0: no difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~H1: difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~Assuming:~* Estimated standard deviation of the change in HbA1c of 1.3%~* Expected mean difference to be detected of 0.4%~* Alpha risk of 5% (two-sided)~* Power of 90%~* Equal sample size in each treatment group (1:1 randomization)~A total number of 446 evaluable patients (223 in each group) was required"||-0.42|-0.77|<0.0001
73877303|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||60.0|-5.0|0.075
73877304|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|14.0||||0.154|TWO_SIDED|95.0|-4.8|32.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||32.7|-4.8|0.154
74000470|NCT02632526|147549130|SUPERIORITY_OR_OTHER||Slope|1.23|STANDARD_ERROR_OF_MEAN|0.0851|||TWO_SIDED|90.0|1.08|1.38||||||Day 10||1.38|1.08|
74000471|NCT02632526|147549131|SUPERIORITY_OR_OTHER||Slope|1.55|STANDARD_ERROR_OF_MEAN|0.0692|||TWO_SIDED|90.0|1.43|1.66||||||||1.66|1.43|
74000472|NCT02632526|147549131|SUPERIORITY_OR_OTHER||Slope|0.35|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|0.0315|0.669||||||||0.669|0.0315|
74000473|NCT02632526|147549132|SUPERIORITY_OR_OTHER||Slope|1.48|STANDARD_ERROR_OF_MEAN|0.0839|||TWO_SIDED|90.0|1.34|1.63||||||For Day 1||1.63|1.34|
74000474|NCT02632526|147549132|SUPERIORITY_OR_OTHER||Slope|1.43|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|1.25|1.6||||||Day 10||1.60|1.25|
74000475|NCT02632526|147549145|SUPERIORITY_OR_OTHER||Ratio|28.13|||||TWO_SIDED|90.0|20.98|37.73||||||Cmax||37.73|20.98|
74000476|NCT02632526|147549146|SUPERIORITY_OR_OTHER||Ratio|64.58|||||TWO_SIDED|90.0|54.34|76.74||||||AUC(0-τ)||76.74|54.34|
74000477|NCT02751320|147549156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.7603|TWO_SIDED|95.0|-8.11|5.94||From ANCOVA: Participant (random), treatment \& period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||5.94|-8.11|0.7603
74000478|NCT02751320|147549156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.3555|TWO_SIDED|95.0|-10.34|3.74||From ANCOVA: Participant (random), treatment \& period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||3.74|-10.34|0.3555
74000479|NCT02751320|147549156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.21||||0.5335|TWO_SIDED|95.0|-4.81|9.23||ANCOVA: Participant (random), treatment \& period (fixed), Participant-level baseline SMH, period-level baseline SMH, Participant-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates)|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||9.23|-4.81|0.5335
74000480|NCT02751320|147549156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.96|||<|0.0001|TWO_SIDED|95.0|16.02|29.9||From ANCOVA: Participant (random), treatment \& period (fixed), Participant -level baseline SMH, period-level baseline SMH, Participant -level pre-treatment acidchallenge SMH and period-level pre-treatment acid challenge SMH (covariates) .|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|Treatment comparison corresponding to qualifying criteria for the analysis||29.90|16.02|<.0001
74000481|NCT03954392|147549168|OTHER||||||<|0.05|||||||ANCOVA|Only one statistical test was conducted, therefore no adjustments for multiple comparisons was needed.||Statistical analysis will compare the post-intervention scores on the primary outcome (Faux Pas Recognition Test scores), controlling for pre-intervention scores.||||< 0.05
74000482|NCT03954392|147549169|OTHER||||||<|0.05|||||||ANCOVA|||||||< 0.05
74000483|NCT01942590|147549271|OTHER|||||||0.0512|||||||t-test, 1 sided|||||||0.0512
74000484|NCT01942590|147549271|OTHER|||||||0.434|||||||t-test, 1 sided|||||||0.434
74000485|NCT01942590|147549272|OTHER|||||||0.0816||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.0816
74000486|NCT01942590|147549272|OTHER|||||||0.3318||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.3318
74000487|NCT01942590|147549273|OTHER|||||||0.2074|||||||t-test, 1 sided|||||||0.2074
73877305|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|4.9||||0.707|TWO_SIDED|95.0|-14.4|24.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||24.2|-14.4|0.707
74000488|NCT01942590|147549273|OTHER|||||||0.332|||||||t-test, 1 sided|||||||0.332
74000489|NCT01942590|147549274|OTHER|||||||0.233||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.233
74000490|NCT01942590|147549274|OTHER|||||||0.142||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.142
74000491|NCT01942590|147549275|OTHER|||||||0.019|||||||t-test, 1 sided|||||||0.019
74000492|NCT01942590|147549275|OTHER|||||||0.366|||||||t-test, 1 sided|||||||0.366
74000493|NCT01942590|147549276|OTHER|||||||0.161|||||||t-test, 1 sided|||||||0.161
74000494|NCT01942590|147549276|OTHER|||||||0.43|||||||t-test, 1 sided|||||||0.43
74000495|NCT01942590|147549277|OTHER|||||||0.01|||||||t-test, 1 sided|||Baseline, week 18||||0.01
74000496|NCT01942590|147549277|OTHER|||||||0.004|||||||t-test, 1 sided|||Baseline, week 52||||0.004
74000497|NCT01942590|147549277|OTHER|||||||0.154|||||||t-test, 1 sided|||Baseline, week 18||||0.154
74000498|NCT01942590|147549277|OTHER|||||||0.211|||||||t-test, 1 sided|||Baseline, Week 52||||0.211
74000499|NCT01942590|147549278|OTHER|||||||0.006|||||||t-test, 1 sided|||Baseline, Week 18||||0.006
74000500|NCT01942590|147549278|OTHER|||||||0.007|||||||t-test, 1 sided|||Baseline, Week 52||||0.007
74000501|NCT01942590|147549278|OTHER|||||||0.297|||||||t-test, 1 sided|||Baseline, Week 18||||0.297
74000502|NCT01942590|147549278|OTHER|||||||0.196|||||||t-test, 1 sided|||Baseline, Week 52||||0.196
74000503|NCT01942590|147549279|OTHER|||||||0.3639|||||||t-test, 1 sided|||Baseline Week 18||||0.3639
74000504|NCT01942590|147549279|OTHER|||||||0.0371|||||||t-test, 1 sided|||Baseline, Week 52||||0.0371
74000505|NCT01942590|147549280|OTHER|||||||0.268|||||||t-test, 1 sided|||Baseline, Week 18||||0.268
74000506|NCT01942590|147549280|OTHER|||||||0.0036|||||||t-test, 1 sided|||Baseline, Week 52||||0.0036
74000507|NCT01942590|147549280|OTHER|||||||0.286|||||||t-test, 1 sided|||Baseline, Week 18||||0.286
74000508|NCT01942590|147549280|OTHER|||||||0.279|||||||t-test, 1 sided|||Baseline, Week 52||||0.279
74000509|NCT01942590|147549281|OTHER|||||||0.479|||||||t-test, 1 sided|||Baseline, Week 18||||0.479
74000510|NCT01942590|147549281|OTHER|||||||0.059|||||||t-test, 1 sided|||Baseline, Week 52||||0.059
74000511|NCT01942590|147549281|OTHER|||||||0.152|||||||t-test, 1 sided|||Baseline, Week 18||||0.152
74000512|NCT01942590|147549281|OTHER|||||||0.118|||||||t-test, 1 sided|||Baseline, Week 52||||0.118
74000513|NCT00857272|147549468|NON_INFERIORITY_OR_EQUIVALENCE|Fifteen percent has been established as an acceptable non-inferiority margin for evaluation of investigational bowel preparations in previous studies of FDA approved preparations (e.g. NuLytely, MoviPrep).|Difference in success rates|-2.5||||0.005|TWO_SIDED|95.0|-11.9|6.8|||Chi-squared|||"The primary endpoint of preparation success was tested using a non-inferiority test based upon the difference D=P1-P2,~Null Hypothesis H0: P1-P2\<=D0 versus Alternative Hypothesis H1: P1-P2=D1\>D0,~Where P1 is the % of patients with successful preps in the HalfLytely 5mg group and P2 is the % of patients with successful preps in the HalfLytely 10mg group and D0 is the acceptable margin of equivalence equal to an absolute margin of 15%."||6.8|-11.9|0.005
74000514|NCT01285609|147549493|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.907||||0.2517|TWO_SIDED|95.0|0.767|1.072|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.072|0.767|0.2517
74000515|NCT01285609|147549494|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.917||||0.2421|TWO_SIDED|95.0|0.792|1.061||p-value based on stratified 2-sided log-rank test|Log Rank||Hazard of Ipilimumab over Placebo with 2-sided 95% confidence intervals based on a stratified Cox proportional hazards model with several stratification factors and treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.061|0.792|0.2421
74000516|NCT01285609|147549495|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.869||||0.0678|TWO_SIDED|95.0|0.749|1.009|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.009|0.749|0.0678
74000517|NCT03283072|147549496|SUPERIORITY|||||||0.592|||||||ANCOVA|Within, within repeated measures ANCOVA (gender as co-variate).||||||0.592
74000518|NCT03283072|147549497|SUPERIORITY|||||||0.721|||||||ANCOVA|Within, within repeated measures ANCOVA (gender as co-variate).||||||0.721
74000519|NCT03283072|147549498|SUPERIORITY|||||||0.553|||||||ANCOVA|Within, within repeated measures ANVOA (gender as covariate)||||||0.553
73957014|NCT02595398|147449978|SUPERIORITY||Difference in percentages|31.25|||<|0.001|TWO_SIDED|95.0|15.5|45.9||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between country strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the country, i.e., US+Israel and India.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|A total sample size of 150 subjects in a 3:2 randomization had 90% power to detect a difference between treatments in the proportion of subjects showing improvement is 0.60 for treated and 0.34 for sham. The primary analysis was a test of superiority of the CLS-TA arm over the sham arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by country.||45.9|15.5|<0.001
73957015|NCT02982213|147450009|SUPERIORITY||Mean Difference (Net)|0.025||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.001
73957016|NCT02982213|147450013|EQUIVALENCE|Sample size of 5 per group to achieve 80% power to detect a change in the log odds ration of 1.0 at a .05 significance level using a two sided Mann Whitney U test.||||||0.001|TWO_SIDED|95.0|||||McNemar|||||||.001
73957017|NCT01549652|147450014|SUPERIORITY_OR_OTHER|||||||0.87||||||Students' t-tests for paired samples with Bonferroni correction for multiple comparisons were used to compare differences between the outcome measures for crossover treatment arms (placebo vs. ondansetron).|t-test, 2 sided|||For the purposes of our post-hoc power calculation we considered a 30% treatment effect clinically significant. Based on the mean observed OOWS score during withdrawal during the placebo session and the variance of that mean score and assuming a paired data analysis and an alpha of 0.05, we found that we had 80% power to detect a treatment effect as low as 25% reduction in OOWS.||||0.87
73957018|NCT01549652|147450015|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
73957019|NCT01549652|147450016|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||||||0.47
73957020|NCT01549652|147450017|SUPERIORITY_OR_OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
73957021|NCT01549652|147450018|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73957022|NCT01549652|147450019|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
73957023|NCT01549652|147450020|SUPERIORITY_OR_OTHER|||||||0.6||||||Students' t-test for paired samples were used to compare differences between the outcome measures for treatment groups (placebo vs. ondansetron).|t-test, 2 sided|||We aimed for a 20% change in OOWS score to show the treatment effect with a power of 80% and an alpha of 0.05, yielding a target of 23 patients per treatment group.||||0.6
73957024|NCT01549652|147450021|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
73957025|NCT01549652|147450022|SUPERIORITY_OR_OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
73957026|NCT01549652|147450023|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||||||0.40
73957027|NCT01549652|147450024|SUPERIORITY_OR_OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
73957028|NCT01549652|147450025|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
73957029|NCT01078246|147450029|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|2.282||||0.002|TWO_SIDED|95.0|1.344|3.875|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||3.875|1.344|0.002
73957030|NCT01078246|147450029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.84|||<|0.05|TWO_SIDED|95.0|1.621|4.977|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||4.977|1.621|<0.05
73957031|NCT01078246|147450029|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.871||||0.005|TWO_SIDED|95.0|1.207|2.899|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||2.899|1.207|0.005
73957032|NCT01078246|147450029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.879||||0.004|TWO_SIDED|95.0|1.227|2.879|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||2.879|1.227|0.004
73957033|NCT01078246|147450029|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.943||||0.008|TWO_SIDED|95.0|1.191|3.168|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||3.168|1.191|0.008
73957034|NCT01078246|147450029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.459||||0.001|TWO_SIDED|95.0|1.454|4.159|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||4.159|1.454|0.001
73957035|NCT01078246|147450029|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.776||||0.004|TWO_SIDED|95.0|1.199|2.631|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||2.631|1.199|0.004
73957036|NCT01078246|147450029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.86||||0.001|TWO_SIDED|95.0|1.274|2.717|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||2.717|1.274|0.001
73957037|NCT01078246|147450030|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.807||||0.255|TWO_SIDED|95.0|0.557|1.168|||Poisson regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.168|0.557|0.255
73957038|NCT01078246|147450030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907||||0.646|TWO_SIDED|95.0|0.597|1.376|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.376|0.597|0.646
73957039|NCT01078246|147450030|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.268||||0.182|TWO_SIDED|95.0|0.895|1.795|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.795|0.895|0.182
73957040|NCT01078246|147450030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.257||||0.188|TWO_SIDED|95.0|0.894|1.768|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.768|0.894|0.188
74000520|NCT02552368|147549515|SUPERIORITY|||||||0.002|||||||Paired t-Test|||||||0.002
73877306|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|25.0||||0.085|TWO_SIDED|95.0|10.0|40.0||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||40.0|10.0|0.085
74090705|NCT01936519|147735409|EQUIVALENCE|Mann Whitney U Test was performed|Mean Difference (Net)|27.32|STANDARD_ERROR_OF_MEAN|20.61||0.283|TWO_SIDED|95.0|-16.17|70.8||Cockcroft-Gault Clearance|Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the Cockcroft Gault Creatinine clearance 2 year data.||70.80|-16.17|0.283
74090706|NCT01936519|147735410|EQUIVALENCE|Wilcoxon Test|Median Difference (Final Values)|34.08|STANDARD_ERROR_OF_MEAN|11.44||0.013|TWO_SIDED|95.0|9.95|58.21|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the MDRD Clearance 2 year data row data.||58.21|9.95|0.013
74090707|NCT01936519|147735411|EQUIVALENCE|Wilcoxon Test|Mean Difference (Final Values)|22.22|STANDARD_ERROR_OF_MEAN|12.09||0.099|TWO_SIDED|95.0|-3.28|47.72|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the Iothalamate Clearance 2 year data.||47.72|-3.28|0.099
74090708|NCT01936519|147735411|EQUIVALENCE|Non-parametric statistical tests were used for all analyses, including the Mann-Whitney U test for continuous outcomes and Pearson's chi-square test for binary outcomes. Univariate statistical tests were used for all comparisons. Cohen's d was utilized for all comparisons to provide information about effect size.|Mean Difference (Final Values)|29.08|STANDARD_ERROR_OF_MEAN|13.29||0.032|TWO_SIDED|95.0|1.04|57.1|||Wilcoxon (Mann-Whitney)|||"Power and sample size. The assumption was made that eGFR would improve from 34 mL/min/1.73 m2 to 43 mL/min/1.73 m2. It was determined that a sample size of 12 in each group would have 80% power to detect a difference in means of -9.0 (the difference between a group 1 mean of 34.0 and a group 2 mean of 43.0) assuming that the common standard deviation was 7.5 using a two group t-test with a 0.05 two-sided significance level.~Data from the 2 year time point was used for analysis."||57.1|1.04|.032
74090709|NCT01936519|147735411|EQUIVALENCE|Difference of zero hypothesized.|Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.263||0.015|TWO_SIDED|95.0|-1.11|-0.003|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on 2 year data time point.||-0.003|-1.11|0.015
74090710|NCT03716076|147735422|OTHER|mixed-effects linear regression|||||||||||||||||To compare time values to baseline, post-hoc Tukey's test was applied|||
74090711|NCT03687658|147735442|OTHER|Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function||||||0.066|||||||Generalized linear mixed model|||||||0.066
74090712|NCT03687658|147735443|OTHER|Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function||||||0.273|||||||Generalized linear mixed model|||||||0.273
74090713|NCT03687658|147735444|OTHER|Generalized linear mixed model (GLMM) with a Poisson distribution using a log link function||||||0.403|||||||Generalized linear mixed model|||||||0.403
74090714|NCT01429051|147735445|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.002|TWO_SIDED|95.0|0.41|1.179|||Mixed Models Analysis|A mixed effects model with episode baseline PI as a covariate, treatment as a fixed effect and patient as a random effect.||||1.179|0.41|0.002
74090715|NCT03728634|147735503|SUPERIORITY||||||<|0.001|||||||Analysis of Variance(ANOVA)|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg||||<0.001
74090716|NCT03728634|147735503|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg||||<0.001
74090717|NCT03728634|147735503|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg||||<0.001
74090718|NCT03728634|147735503|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg||||<0.001
74090719|NCT03728634|147735503|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg||||<0.001
74090720|NCT03728634|147735503|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg||||<0.001
74090721|NCT03728634|147735503|SUPERIORITY|||||||0.036|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg||||0.036
74090722|NCT03728634|147735504|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg||||<0.001
74090723|NCT03728634|147735504|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg||||<0.001
74090724|NCT03728634|147735504|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg||||<0.001
74090725|NCT03728634|147735504|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg||||<0.001
74090726|NCT03728634|147735504|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg||||<0.001
74090727|NCT03728634|147735504|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg||||<0.001
74090728|NCT03728634|147735504|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank Sum Exact Test (2-sided)|||Change From Baseline in Plasma RBP4 Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg||||0.036
74090729|NCT01338649|147735527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0211|||||||t-test, 2 sided|t-test on two groups of differences||||||0.0211
74090730|NCT00361335|147735545|SUPERIORITY_OR_OTHER|||||||0.051||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group VI at α = 0.05.||||0.051
73877307|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|14.7||||0.137|TWO_SIDED|95.0|-4.0|33.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||33.3|-4.0|0.137
73877308|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-11.8||||0.37|TWO_SIDED|95.0|-38.2|14.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||14.5|-38.2|0.370
73877309|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-3.6||||1|TWO_SIDED|95.0|-31.6|24.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||24.4|-31.6|1.000
73877310|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-16.4||||0.174|TWO_SIDED|95.0|-39.8|7.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||7.0|-39.8|0.174
73877311|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-17.1||||0.203|TWO_SIDED|95.0|-43.9|9.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||9.7|-43.9|0.203
73877312|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|20.1||||0.286|TWO_SIDED|95.0|-4.5|44.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||44.7|-4.5|0.286
73877313|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-3.6||||0.773|TWO_SIDED|95.0|-27.7|20.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||20.6|-27.7|0.773
73877314|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-23.5||||0.101|TWO_SIDED|95.0|-51.2|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||4.1|-51.2|0.101
73877315|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|15.2||||0.332|TWO_SIDED|95.0|-14.1|44.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||44.4|-14.1|0.332
73877316|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|16.2||||0.189|TWO_SIDED|95.0|-7.5|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||39.8|-7.5|0.189
73877317|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-14.1||||0.329|TWO_SIDED|95.0|-42.2|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||13.9|-42.2|0.329
73877318|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|24.6||||0.124|TWO_SIDED|95.0|-4.8|53.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||53.9|-4.8|0.124
73877319|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|15.2||||0.234|TWO_SIDED|95.0|-9.5|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||39.9|-9.5|0.234
73957041|NCT01078246|147450031|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.016||||0.897|TWO_SIDED|95.0|0.796|1.297|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.297|0.796|0.897
73957042|NCT01078246|147450031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.287||||0.07|TWO_SIDED|95.0|0.98|1.69|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.690|0.980|0.070
73957043|NCT01078246|147450031|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.067||||0.575|TWO_SIDED|95.0|0.85|1.339|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.339|0.850|0.575
73957044|NCT01078246|147450031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.626|TWO_SIDED|95.0|0.847|1.319|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.319|0.847|0.626
74000521|NCT02552368|147549516|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Performance COPM between Baseline and 12 weeks||||0.022
73877320|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-10.0||||0.484|TWO_SIDED|95.0|-37.8|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||17.7|-37.8|0.484
73877321|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-57.3|37.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||37.3|-57.3|1.000
73877322|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-11.2||||0.431|TWO_SIDED|95.0|-38.9|16.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||16.5|-38.9|0.431
73877323|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-20.7||||0.25|TWO_SIDED|95.0|-48.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||7.1|-48.5|0.250
73877324|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-40.9|50.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||50.9|-40.9|1.000
73877325|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-25.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||23.3|-25.2|1.000
73877326|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-5.7||||1|TWO_SIDED|95.0|-31.1|19.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||19.6|-31.1|1.000
73877327|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||55.2|-35.2|0.544
73877328|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-22.4|20.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||20.9|-22.4|1.000
73877329|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-7.9||||0.627|TWO_SIDED|95.0|-28.5|12.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||12.8|-28.5|0.627
73877330|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|1.000
74000522|NCT02552368|147549516|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Satisfaction COPM between Baseline and 12 weeks||||0.031
74000523|NCT03616977|147549517|EQUIVALENCE|Bioequivalence will be concluded if the 2-sided 90% Confidence Interval is completely contained within the interval (0.80, 1.25).|Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.961|1.06||||||||1.06|0.961|
74000524|NCT02915302|147549550|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the difference in fever rate was \<5%.|Difference in Fever Rate|0.84|||||TWO_SIDED|95.0|-2.13|3.8|||||Fever rate: Fluzone Quadrivalent vaccine (0.5-mL vs. 0.25-mL)|Difference in fever rate was defined as the fever rate following a 0.5-mL dose of Fluzone Quadrivalent vaccine minus the fever rate following a 0.25-mL dose of Fluzone Quadrivalent vaccine.||3.80|-2.13|
74000525|NCT02915302|147549551|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (A/H1N1)|1.45|||||TWO_SIDED|95.0|1.19|1.77|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.77|1.19|
74000526|NCT02915302|147549551|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (A/H3N2)|1.5|||||TWO_SIDED|95.0|1.23|1.83|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.83|1.23|
73877331|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||17.7|-18.7|1.000
73877332|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|4.3||||1|TWO_SIDED|95.0|-18.3|26.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||26.8|-18.3|1.000
74000527|NCT02915302|147549551|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (B Victoria lineage)|1.33|||||TWO_SIDED|95.0|1.1|1.62|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.62|1.10|
74000528|NCT02915302|147549551|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (B Yamagata lineage)|1.44|||||TWO_SIDED|95.0|1.2|1.73|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.73|1.20|
74000529|NCT02915302|147549552|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (A/H1N1)|5.1|||||TWO_SIDED|95.0|0.189|10.0|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||10.0|0.189|
74000530|NCT02915302|147549552|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (A/H3N2)|4.3|||||TWO_SIDED|95.0|-0.283|8.99|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||8.99|-0.283|
74000531|NCT02915302|147549552|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (B Victoria lineage)|1.4|||||TWO_SIDED|95.0|-2.78|5.56|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||5.56|-2.78|
74000532|NCT02915302|147549552|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (B Yamagata lineage)|3.4|||||TWO_SIDED|95.0|-0.465|7.36|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||7.36|-0.465|
74000533|NCT03527173|147549553|NON_INFERIORITY|VE in reduction of shigellosis is demonstrated if lower limit (LL) of 90% CI of VE estimated with Miettinen-Nurminen (M-N) method is above 0. This estimated CI was complemented with Barnard test. The LL of the 90% CI for VE calculated with M-N method is above 0 if the p-value of the one-sided Barnard test is below 5%.|Vaccine efficacy rate|-9.4||||0.4266|TWO_SIDED|90.0|-96.7|33.7|||1-sided Barnard Unconditional Exact Test|||To demonstrate the efficacy of two vaccinations with 25 µg of S. sonnei vaccine in healthy adults compared to placebo in preventing shigellosis, fulfilling the protocol primary case definition, after challenge with S. sonnei 53G strain. Vaccine efficacy (VE) rate was assessed as 1-Risk Ratio(RR) with RR = ratio of proportion of subjects with shigellosis in the vaccinated group on the proportion of subjects with shigellosis in the placebo group.||33.7|-96.7|0.4266
74000534|NCT01190514|147549612|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|95.56|||||TWO_SIDED|90.0|86.94|105.04|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||105.04|86.94|
74000535|NCT01190514|147549612|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|101.31|||||TWO_SIDED|90.0|97.17|105.64|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||105.64|97.17|
73877333|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|14.3||||0.232|TWO_SIDED|95.0|-0.7|29.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||29.3|-0.7|0.232
74000536|NCT01190514|147549612|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|108.76|||||TWO_SIDED|90.0|101.1|117.01|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||117.01|101.10|
74000537|NCT01190514|147549614|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|95.1|||||TWO_SIDED|90.0|89.37|101.2|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||101.20|89.37|
74000538|NCT01190514|147549614|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|101.3|||||TWO_SIDED|90.0|94.66|108.4|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||108.40|94.66|
74000539|NCT01190514|147549614|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|115.54|||||TWO_SIDED|90.0|108.59|122.94|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||122.94|108.59|
74000540|NCT03241225|147549627|SUPERIORITY||Mean Difference (Final Values)|3.59||||0.16|TWO_SIDED|95.0|-1.43|8.61|||t-test, 2 sided||Mean change in EM/PROTECT group not significantly different from mean change in EM/MH group, at week 12.|Week 12||8.61|-1.43|0.16
74000541|NCT03241225|147549628|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.79|TWO_SIDED|95.0|-1.37|1.05|||t-test, 2 sided|||Domain #1, Week 12||1.05|-1.37|0.79
74000542|NCT03241225|147549628|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.19|TWO_SIDED|95.0|-0.7|3.46|||t-test, 2 sided|||Domain #2, Week 12||3.46|-0.70|0.19
74000543|NCT03241225|147549628|SUPERIORITY||Mean Difference (Final Values)|-4.53||||0.37|TWO_SIDED|95.0|-14.99|5.93|||t-test, 2 sided|||Domain #3, Week 12||5.93|-14.99|0.37
74036787|NCT03259490|147626938|OTHER||Adjusted gmean ratio T/R (%)|103.06|STANDARD_DEVIATION|5.8|||TWO_SIDED|95.0|100.36|105.83|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.83|100.36|
74036788|NCT03259490|147626939|OTHER||Adjusted gmean ratio T/R (%)|100.35|STANDARD_DEVIATION|9.5|||TWO_SIDED|95.0|96.11|104.77|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.77|96.11|
74036789|NCT03259490|147626940|OTHER||Adjusted gmean ratio T/R (%)|100.31|STANDARD_DEVIATION|8.2|||TWO_SIDED|95.0|96.65|104.1|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.10|96.65|
74036790|NCT03259490|147626941|OTHER||Adjusted gmean ratio T/R (%)|99.95|STANDARD_DEVIATION|12.4|||TWO_SIDED|95.0|94.52|105.7|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.70|94.52|
74036791|NCT03259490|147626942|OTHER||Adjusted gmean ratio T/R (%)|107.78|STANDARD_DEVIATION|11.0|||TWO_SIDED|95.0|102.52|113.31|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||113.31|102.52|
74036792|NCT03259490|147626943|OTHER||Adjusted gmean ratio T/R (%)|97.17|STANDARD_DEVIATION|10.6|||TWO_SIDED|95.0|92.63|101.93|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||101.93|92.63|
74036793|NCT03259490|147626944|OTHER||Adjusted gmean ratio T/R (%)|103.11|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|100.38|105.92|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.92|100.38|
74036794|NCT03259490|147626945|OTHER||Adjusted gmean ratio T/R (%)|100.17|STANDARD_DEVIATION|10.1|||TWO_SIDED|95.0|95.68|104.86|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.86|95.68|
74036795|NCT03259490|147626946|OTHER||Adjusted gmean ratio T/R (%)|97.3|STANDARD_DEVIATION|13.2|||TWO_SIDED|95.0|91.65|103.29|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||103.29|91.65|
74036796|NCT05027516|147626949|SUPERIORITY||Ratio|1.05||||0.1026|TWO_SIDED|95.0|0.55|1.83|||Permutation testing|||||1.83|0.55|0.1026
74036797|NCT05027516|147626950|SUPERIORITY||Ratio|1.12||||1|TWO_SIDED|95.0|0.47|2.19|||Permutation testing|||For aminoglycosides||2.19|0.47|1
74036798|NCT05027516|147626950|SUPERIORITY||Ratio|1.01||||1|TWO_SIDED|95.0|0.69|1.44|||Permutation testing|||For betalactams||1.44|0.69|1
74036799|NCT05027516|147626950|SUPERIORITY||Ratio|3.79||||1|TWO_SIDED|95.0|0.05|20.15|||Permutation testing|||For bacitracin||20.15|0.05|1
74036800|NCT05027516|147626950|SUPERIORITY||Ratio|0.83||||1|TWO_SIDED|95.0|0.0|1.91|||Permutation testing|||For glycopeptides||1.91|0|1
74036801|NCT05027516|147626950|SUPERIORITY||Ratio|1.19||||1|TWO_SIDED|95.0|0.32|3.15|||Permutation testing|||For trimethoprim||3.15|0.32|1
74036802|NCT05027516|147626950|SUPERIORITY||Ratio|2.82||||1|TWO_SIDED|95.0|0.07|14.64|||Permutation testing|||For cationic antimicrobial peptides||14.64|0.07|1
74036803|NCT05027516|147626950|SUPERIORITY||Ratio|1.49||||1|TWO_SIDED|95.0|0.0|5.34|||Permutation testing|||For mupirocin||5.34|0|1
74036804|NCT05027516|147626950|SUPERIORITY||Ratio|1.2||||1|TWO_SIDED|95.0|0.0|3.22|||Permutation testing|||For metronidazole||3.22|0|1
74036805|NCT05027516|147626950|SUPERIORITY||Ratio|6.44||||1|TWO_SIDED|95.0|0.02|46.02|||Permutation testing|||For fluoroquinolones||46.02|0.02|1
74036806|NCT05027516|147626950|SUPERIORITY||Ratio|10.6||||1|TWO_SIDED|95.0|0.01|148.86|||Permutation testing|||For sulfonamides||148.86|0.01|1
74036807|NCT05027516|147626950|SUPERIORITY||Ratio|1.01||||0.5621|TWO_SIDED|95.0|0.79|1.27|||Permutation testing|||For tetracyclines||1.27|0.79|0.5621
74036808|NCT05027516|147626951|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||For streptococci||||0.196
74036809|NCT05027516|147626951|SUPERIORITY|||||||0.568|||||||Wilcoxon (Mann-Whitney)|||For streptococci||||0.568
74036810|NCT05027516|147626951|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||For Neisseria||||0.978
74036811|NCT05027516|147626951|SUPERIORITY|||||||0.184|||||||Wilcoxon (Mann-Whitney)|||For Neisseria||||0.184
74036812|NCT03655717|147626957|SUPERIORITY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.113||0.94|TWO_SIDED|95.0|-0.259|0.184||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with dronabinol (i.e., a main effect for dronabinol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.184|-0.259|0.94
74036813|NCT03655717|147626957|SUPERIORITY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.206||0.94|TWO_SIDED|95.0|-0.421|0.386||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with ethanol (i.e., a main effect for ethanol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.386|-0.421|0.94
74039822|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.41|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.41|-0.99|<.0001
74036814|NCT03655717|147626957|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.281||0.94|TWO_SIDED|95.0|-0.535|0.568||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with both dronabinol and ethanol (i.e., the interaction between dronabinol and ethanol doses), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.568|-0.535|0.94
74036815|NCT03655717|147626958|SUPERIORITY||Mean Difference (Final Values)|-0.163|STANDARD_ERROR_OF_MEAN|0.113||0.94|TWO_SIDED|95.0|-0.384|0.057||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with dronabinol (i.e., a main effect for dronabinol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.057|-0.384|0.94
73877334|NCT02365649|147294861|SUPERIORITY||Risk Difference (RD)|7.1||||0.412|TWO_SIDED|95.0|-6.3|20.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||20.6|-6.3|0.412
74000544|NCT03241225|147549628|SUPERIORITY||Mean Difference (Final Values)|-5.24||||0.026|TWO_SIDED|95.0|-9.75|-0.73|||t-test, 2 sided|||Domain #4, Week 12||-0.73|-9.75|0.026
73877335|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-745.7||||0.356|TWO_SIDED|95.0|-2369.73|878.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||878.37|-2369.73|0.356
73877336|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-1119.5||||0.158|TWO_SIDED|95.0|-2698.52|459.5||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||459.50|-2698.52|0.158
74000545|NCT03241225|147549628|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.66|TWO_SIDED|95.0|-3.51|2.27|||t-test, 2 sided|||Domain #5, Week 12||2.27|-3.51|0.66
74000546|NCT03241225|147549629|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.14|TWO_SIDED|95.0|-0.26|1.66|||t-test, 2 sided|||Domain #1, Week 12||1.66|-0.26|0.14
74000547|NCT03241225|147549629|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.047|TWO_SIDED|95.0|0.011|1.55||Domain #2|t-test, 2 sided|||Domain #2, Week 12||1.55|0.011|0.047
74000548|NCT03241225|147549629|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.18|TWO_SIDED|95.0|-0.34|1.64|||t-test, 2 sided|||Domain #3, Week 12||1.64|-0.34|0.18
74000549|NCT04601870|147549662|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4137|TWO_SIDED|95.0|0.566|3.973|||Chi-squared|Chi squared equals 0.668 with 1 degrees of freedom|Odds ratio for completing counseling in $50 arm vs. $0 arm|||3.973|.566|0.4137
74036816|NCT03655717|147626958|SUPERIORITY||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.21||0.94|TWO_SIDED|95.0|-0.588|0.237||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with ethanol (i.e., a main effect for ethanol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.237|-0.588|0.94
74036817|NCT03655717|147626958|SUPERIORITY||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.276||0.94|TWO_SIDED|95.0|-0.354|0.728||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with both dronabinol and ethanol (i.e., the interaction between dronabinol and ethanol doses), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.728|-0.354|0.94
74036818|NCT01185249|147626959|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis-no difference in morning and evening weights on three consecutive days.|Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|3.09|<|0.001|TWO_SIDED|95.0|-0.51306|1.73806|||t-test, 1 sided|||Analysis of within subjects design morning and evening weights. Null hypothesis is that there is no difference between morning and evening weights.||1.73806|-0.51306|<.001
74036819|NCT01185249|147626959|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||||||0.01
74036820|NCT00406783|147626971|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74036821|NCT00406783|147626972|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
73877337|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-1166.0||||0.322|TWO_SIDED|95.0|-3531.3|1199.32||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||1199.32|-3531.30|0.322
73877338|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-828.2||||0.287|TWO_SIDED|95.0|-2387.16|730.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||730.75|-2387.16|0.287
73877339|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-1286.1||||0.088|TWO_SIDED|95.0|-2772.59|200.43||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Responders, Week 52||200.43|-2772.59|0.088
73877340|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-502.2||||0.613|TWO_SIDED|95.0|-2505.74|1501.38||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||1501.38|-2505.74|0.613
73877341|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|283.4||||0.609|TWO_SIDED|95.0|-823.64|1390.49||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||1390.49|-823.64|0.609
73877342|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-78.2||||0.855|TWO_SIDED|95.0|-930.47|774.16||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||774.16|-930.47|0.855
73877343|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|283.5||||0.584|TWO_SIDED|95.0|-751.66|1318.57||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||1318.57|-751.66|0.584
74000550|NCT04601870|147549662|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4137|TWO_SIDED|95.0|0.566|3.973|||Chi-squared|Chi squared equals 0.668 with 1 degrees of freedom|Odds ratio for completing counseling in $100 arm vs. $0 arm|||3.973|.566|0.4137
73877344|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|356.6||||0.624|TWO_SIDED|95.0|-1095.03|1808.19||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||1808.19|-1095.03|0.624
73957045|NCT01078246|147450033|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.389|||<|0.0001|TWO_SIDED|95.0|0.274|0.551|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||0.551|0.274|<0.0001
73957046|NCT01078246|147450033|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.471|||<|0.05|TWO_SIDED|95.0|0.314|0.707|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||0.707|0.314|<0.05
73957047|NCT01078246|147450033|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.65||||0.015|TWO_SIDED|95.0|1.102|2.47|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.470|1.102|0.015
73957048|NCT01078246|147450033|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.622||||0.018|TWO_SIDED|95.0|1.085|2.425|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.425|1.085|0.018
73957049|NCT01078246|147450034|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.75||||0.423|TWO_SIDED|95.0|0.37|1.517|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.517|0.370|0.423
73957050|NCT01078246|147450034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.208||||0.631|TWO_SIDED|95.0|0.559|2.612|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.612|0.559|0.631
73957051|NCT01078246|147450034|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.845||||0.592|TWO_SIDED|95.0|0.458|1.561|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.561|0.458|0.592
73957052|NCT01078246|147450034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.022||||0.943|TWO_SIDED|95.0|0.565|1.85|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.850|0.565|0.943
73957053|NCT01078246|147450035|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.708||||0.109|TWO_SIDED|95.0|0.464|1.08|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.080|0.464|0.109
73957054|NCT01078246|147450035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.356|TWO_SIDED|95.0|0.486|1.296|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.296|0.486|0.356
73957055|NCT01078246|147450035|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.556||||0.039|TWO_SIDED|95.0|1.022|2.37|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.370|1.022|0.039
73957056|NCT01078246|147450035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.033|TWO_SIDED|95.0|1.036|2.361|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.361|1.036|0.033
74000551|NCT04601870|147549662|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3383|TWO_SIDED|95.0|0.653|3.446|||Chi-squared|Chi squared equals 0.917 with 1 degrees of freedom|Odds ratio for completing counseling in $50 or $100 arm vs. $0 arm|$0 vs. $50 or $100||3.446|.653|.3383
74000552|NCT04601870|147549663|SUPERIORITY||Odds Ratio (OR)|2.333||||0.265|TWO_SIDED|95.0|0.51|10.6751|||Chi-squared|Chi squared equals 1.243 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 arm vs. $0 arm|||10.6751|.5100|.2650
73877345|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-135.1||||0.806|TWO_SIDED|95.0|-1233.48|963.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||963.25|-1233.48|0.806
73877346|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|186.2||||0.793|TWO_SIDED|95.0|-1229.59|1602.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||1602.06|-1229.59|0.793
73877347|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-304.8||||0.561|TWO_SIDED|95.0|-1350.04|740.44||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||740.44|-1350.04|0.561
73877348|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-1119.0||||0.024|TWO_SIDED|95.0|-2083.81|-154.11||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders, Week 28||-154.11|-2083.81|0.024
73877349|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-819.3||||0.156|TWO_SIDED|95.0|-1959.79|321.21||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||321.21|-1959.79|0.156
73877350|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-346.6||||0.58|TWO_SIDED|95.0|-1592.66|899.45||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||899.45|-1592.66|0.580
73877351|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-1275.9||||0.029|TWO_SIDED|95.0|-2415.88|-135.92||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders, Week 52||-135.92|-2415.88|0.029
73877352|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-534.9||||0.431|TWO_SIDED|95.0|-1883.23|813.5||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||813.50|-1883.23|0.431
73877353|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|-25.4||||0.965|TWO_SIDED|95.0|-1200.67|1149.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1149.95|-1200.67|0.965
73877354|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|623.6||||0.123|TWO_SIDED|95.0|-183.52|1430.64||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1430.64|-183.52|0.123
74000553|NCT04601870|147549663|SUPERIORITY||Odds Ratio (OR)|0.8333||||0.8472|TWO_SIDED|95.0|0.1301|5.3369|||Chi-squared|Chi squared equals 0.037 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $0 arm|||5.3369|.1301|.8472
73877355|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|368.2||||0.591|TWO_SIDED|95.0|-1031.23|1767.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1767.60|-1031.23|0.591
73877356|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|192.2||||0.642|TWO_SIDED|95.0|-648.22|1032.68||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||1032.68|-648.22|0.642
73877357|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|455.8||||0.093|TWO_SIDED|95.0|-81.37|992.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical non-responders, Week 52||992.95|-81.37|0.093
73877358|NCT02365649|147294862|SUPERIORITY||LS Mean of Difference|463.6||||0.296|TWO_SIDED|95.0|-428.99|1356.2||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||1356.20|-428.99|0.296
73877359|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-2.0||||0.822|TWO_SIDED|95.0|-19.83|15.83||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||15.83|-19.83|0.822
74000554|NCT04601870|147549663|SUPERIORITY||Odds Ratio (OR)|1.541||||0.5478|TWO_SIDED|95.0|0.3731|6.364|||Chi-squared|Chi squared equals 0.361 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 or $100 arms vs. $0 arm|$0 vs. $50 or $100||6.3640|.3731|.5478
74000555|NCT04601870|147549663|SUPERIORITY||Odds Ratio (OR)|0.3571||||0.2276|TWO_SIDED|95.0|0.06355|2.007|||Chi-squared|Chi squared equals 1.456 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $50 arm|||2.0070|.06355|.2276
74008678|NCT00718549|147567463|SUPERIORITY||Hazard Ratio (HR)|0.769||||0.752|TWO_SIDED|95.0|0.151|3.92|||Cox's proportional hazards model|||Multivariate Comparison: Age \<60 years versus Age \>/=60 years||3.920|0.151|0.752
74008679|NCT00718549|147567463|SUPERIORITY||Hazard Ratio (HR)|0.068||||0.128|TWO_SIDED|95.0|0.002|2.158|||Cox's proportional hazards model|||Multivariate Comparison: Sex: Female versus Male||2.158|0.002|0.128
73877360|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-6.4||||0.386|TWO_SIDED|95.0|-20.97|8.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||8.25|-20.97|0.386
74000556|NCT03932812|147549665|SUPERIORITY||Mean Difference (Net)|1.128|STANDARD_ERROR_OF_MEAN|1.622||0.206|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.206
74000557|NCT03932812|147549666|SUPERIORITY||Mean Difference (Final Values)|2.376|STANDARD_ERROR_OF_MEAN|1.793||0.101|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.101
74000558|NCT03932812|147549667|SUPERIORITY||Mean Difference (Net)|-0.201|STANDARD_ERROR_OF_MEAN|1.174||0.836|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.836
74000559|NCT03932812|147549668|SUPERIORITY||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.414||0.567|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|The outcome for this analyses is use of emergency care.||||0.567
74000560|NCT03932812|147549669|SUPERIORITY||Mean Difference (Final Values)|-0.363|STANDARD_ERROR_OF_MEAN|0.165||0.014|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|||||0.014
74000561|NCT03932812|147549670|SUPERIORITY||Mean Difference (Final Values)|0.467|STANDARD_ERROR_OF_MEAN|0.301||0.01|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|||||0.010
74000562|NCT03932812|147549671|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|2.682||0.188|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.188
74000563|NCT04193436|147549672|OTHER||Ratio (%) of Adjusted Means|92.89|||||TWO_SIDED|90.0|68.15|126.6||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way analysis of variance (ANOVA) model based on natural log transformed data.||126.60|68.15|
74000564|NCT04193436|147549672|OTHER||Ratio (%) of Adjusted Means|134.4|||||TWO_SIDED|90.0|98.61|183.17||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||183.17|98.61|
73877361|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|12.9||||0.136|TWO_SIDED|95.0|-4.22|29.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||29.95|-4.22|0.136
74000565|NCT04193436|147549672|OTHER||Ratio (%) of Adjusted Means|139.33|||||TWO_SIDED|90.0|100.69|192.78||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||192.78|100.69|
74000566|NCT04193436|147549673|OTHER||Ratio (%) of Adjusted Means|87.2|||||TWO_SIDED|90.0|63.61|119.53||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||119.53|63.61|
74000567|NCT04193436|147549673|OTHER||Ratio (%) of Adjusted Means|102.24|||||TWO_SIDED|90.0|74.59|140.15||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||140.15|74.59|
74000568|NCT04193436|147549673|OTHER||Ratio (%) of Adjusted Means|83.78|||||TWO_SIDED|90.0|60.18|116.62||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||116.62|60.18|
74000569|NCT04193436|147549674|OTHER||Ratio (%) of Adjusted Means|121.81|||||TWO_SIDED|90.0|88.69|167.31||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||167.31|88.69|
74000570|NCT04193436|147549674|OTHER||Ratio (%) of Adjusted Means|178.5|||||TWO_SIDED|90.0|129.96|245.18||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||245.18|129.96|
73877362|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|1.0||||0.912|TWO_SIDED|95.0|-17.87|19.97||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||19.97|-17.87|0.912
73877363|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-12.3||||0.118|TWO_SIDED|95.0|-27.77|3.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||3.25|-27.77|0.118
73877364|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|12.5||||0.171|TWO_SIDED|95.0|-5.61|30.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||30.65|-5.61|0.171
73877365|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-6.9||||0.479|TWO_SIDED|95.0|-26.5|12.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 36||12.63|-26.50|0.479
73877366|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-17.1||||0.037|TWO_SIDED|95.0|-33.12|-1.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders, Week 36||-1.04|-33.12|0.037
73877367|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|6.9||||0.463|TWO_SIDED|95.0|-11.86|25.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 36||25.65|-11.86|0.463
73877368|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-4.6||||0.627|TWO_SIDED|95.0|-23.59|14.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||14.37|-23.59|0.627
73877369|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-12.2||||0.122|TWO_SIDED|95.0|-27.75|3.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||3.37|-27.75|0.122
74000571|NCT04193436|147549674|OTHER||Ratio (%) of Adjusted Means|195.73|||||TWO_SIDED|90.0|140.31|273.03||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||273.03|140.31|
74000572|NCT04193436|147549675|OTHER||Ratio (%) of Adjusted Means|114.45|||||TWO_SIDED|90.0|88.13|148.63||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||148.63|88.13|
73877370|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|10.7||||0.243|TWO_SIDED|95.0|-7.49|28.89||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||28.89|-7.49|0.243
73877371|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-4.2||||0.658|TWO_SIDED|95.0|-22.95|14.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||14.63|-22.95|0.658
73877372|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-12.3||||0.115|TWO_SIDED|95.0|-27.69|3.12||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||3.12|-27.69|0.115
73877373|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|10.0||||0.267|TWO_SIDED|95.0|-7.96|28.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||28.06|-7.96|0.267
74000573|NCT04193436|147549675|OTHER||Ratio (%) of Adjusted Means|136.04|||||TWO_SIDED|90.0|104.75|176.67||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||176.67|104.75|
73877374|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|0.2||||0.974|TWO_SIDED|95.0|-9.74|10.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||10.06|-9.74|0.974
74036822|NCT02300077|147627006|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
74036823|NCT02300077|147627007|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
74036824|NCT02300077|147627008|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
74036825|NCT02300077|147627009|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
74036826|NCT00961662|147627025|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||The HbA1c percent change at each study visit was calculated and then categorized as a binary response (i.e., responders and non-responders) for each subject based on the breakpoint to be used in the endpoint. Inferential statistics were prepared to compare the differences across the three treatments a using logistic regression model with the dose group and the HbA1c stratum included in the mode||||<0.05
73877375|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-0.5||||0.882|TWO_SIDED|95.0|-7.61|6.55||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||6.55|-7.61|0.882
73877376|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-0.1||||0.982|TWO_SIDED|95.0|-7.92|7.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||7.75|-7.92|0.982
73877377|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|2.2||||0.673|TWO_SIDED|95.0|-8.11|12.51||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||12.51|-8.11|0.673
73877378|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|2.7||||0.467|TWO_SIDED|95.0|-4.64|10.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||10.04|-4.64|0.467
73877379|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|2.2||||0.583|TWO_SIDED|95.0|-5.79|10.23||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||10.23|-5.79|0.583
73877380|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|5.5||||0.564|TWO_SIDED|95.0|-13.33|24.31||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||24.31|-13.33|0.564
73877381|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-2.4||||0.728|TWO_SIDED|95.0|-15.74|11.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||11.04|-15.74|0.728
74000574|NCT04193436|147549675|OTHER||Ratio (%) of Adjusted Means|117.87|||||TWO_SIDED|90.0|89.61|155.03||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||155.03|89.61|
74000575|NCT02585232|147549680|SUPERIORITY|||||||0.483|||||||ANCOVA|Caregiver education, cognitive status of the person with dementia, and baseline caregiver burden scores were included in the model as covariates.||||||.483
74000576|NCT02585232|147549681|SUPERIORITY|||||||0.169|||||||ANCOVA|Caregiver education, cognitive status of the person with dementia, and baseline Dyadic Adjustment Scale scores were included as covariates.||Only caregivers that were currently or previously in a romantic relationship (e.g., spouses, partners) with the person with dementia reported on the Dyadic Adjustment Scale (i.e., N = 20, n = 9 in CC group and n = 11 in CC+C group).||||0.169
73877382|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|5.5||||0.46|TWO_SIDED|95.0|-9.16|20.08||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||20.08|-9.16|0.460
73877383|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|12.0||||0.253|TWO_SIDED|95.0|-8.72|32.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||32.75|-8.72|0.253
74000577|NCT02585232|147549682|SUPERIORITY|||||||0.763|||||||ANCOVA|Baseline quality of life scores, education, and cognitive status were included as covariates in the model.||||||0.763
74000578|NCT02585232|147549683|SUPERIORITY|||||||0.78|||||||ANCOVA|Baseline depression scores, cognitive status scores (i.e., MoCA), and education were included in the model as covariates.||||||0.780
74000579|NCT02313233|147549689|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
73877384|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|1.1||||0.884|TWO_SIDED|95.0|-13.67|15.84||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||15.84|-13.67|0.884
74000580|NCT02313233|147549690|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
73877385|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|5.8||||0.474|TWO_SIDED|95.0|-10.28|21.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||21.95|-10.28|0.474
74000581|NCT02313233|147549693|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
74000582|NCT02313233|147549694|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
74008680|NCT00718549|147567463|SUPERIORITY||Hazard Ratio (HR)|2.282||||0.728|TWO_SIDED|95.0|0.022|240.864|||Cox's proportional hazards model|||Multivariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||240.864|0.022|0.728
74008681|NCT00718549|147567463|SUPERIORITY||Hazard Ratio (HR)|26.275||||0.048|TWO_SIDED|95.0|1.036|666.708|||Cox's proportional hazards model|||Multivariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||666.708|1.036|0.048
73877386|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|3.6||||0.727|TWO_SIDED|95.0|-17.03|24.3||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||24.30|-17.03|0.727
73877387|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|2.1||||0.78|TWO_SIDED|95.0|-12.63|16.78||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||16.78|-12.63|0.780
73877388|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|6.5||||0.424|TWO_SIDED|95.0|-9.57|22.54||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||22.54|-9.57|0.424
73877389|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-1.3||||0.841|TWO_SIDED|95.0|-14.23|11.62||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||11.62|-14.23|0.841
73877390|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-2.1||||0.702|TWO_SIDED|95.0|-12.94|8.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||8.75|-12.94|0.702
73877391|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|5.7||||0.353|TWO_SIDED|95.0|-6.43|17.83||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||17.83|-6.43|0.353
73877392|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|2.1||||0.77|TWO_SIDED|95.0|-11.89|16.0||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||16.00|-11.89|0.770
74000583|NCT02679573|147549709|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|-0.2|||||TWO_SIDED|95.0|-4.4|4.1|||||Difference = Difference in responder rates (Delafloxacin treatment group minus Moxifloxacin treatment group). Confidence intervals are calculated using Miettinen and Nurminen method without stratification.|"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125 where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) were presented, and the Miettinen-Nurminen test, without stratification, was used for the 2 sided 95% CI on the difference in response rate."||4.1|-4.4|
74000584|NCT02679573|147549710|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|9.7|||||TWO_SIDED|95.0|3.0|16.3||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||16.3|3.0|
74008682|NCT00718549|147567463|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.417|TWO_SIDED|95.0|0.005|9.1|||Cox's proportional hazards model|||Multivariate Comparison: ZAP-70 Expression Negative versus Positive||9.100|0.005|0.417
74008683|NCT00718549|147567463|SUPERIORITY||Hazard Ratio (HR)|0.197||||0.134|TWO_SIDED|95.0|0.024|1.647|||Cox's proportional hazards model|||Multivariate Comparison: CD38 Expression Negative versus Positive||1.647|0.024|0.134
74008684|NCT00718549|147567463|SUPERIORITY||Hazard Ratio (HR)|8.373||||0.426|TWO_SIDED|95.0|0.045|1568.717|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 17p No versus Yes||1568.717|0.045|0.426
74090731|NCT00361335|147735545|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups I vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31% response in the Group I at α = 0.05.||||0.073
73877393|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-5.3||||0.367|TWO_SIDED|95.0|-17.04|6.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||6.37|-17.04|0.367
73877394|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|7.0||||0.291|TWO_SIDED|95.0|-6.09|20.07||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||20.07|-6.09|0.291
74008685|NCT00718549|147567463|SUPERIORITY||Hazard Ratio (HR)|0.438||||0.733|TWO_SIDED|95.0|0.004|50.334|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 13q No versus Yes||50.334|0.004|0.733
74090732|NCT00361335|147735545|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups III vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group III at α = 0.05.||||0.093
74000585|NCT02679573|147549711|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||TWO_SIDED|95.0|-3.3|4.8||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||4.8|-3.3|
74000586|NCT02679573|147549712|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||TWO_SIDED|95.0|-3.0|4.6||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||4.6|-3.0|
74008686|NCT00718549|147567463|SUPERIORITY||Hazard Ratio (HR)|2.621||||0.463|TWO_SIDED|95.0|0.2|34.422|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 11q No versus Yes||34.422|0.200|0.463
74008687|NCT00718549|147567463|SUPERIORITY||Hazard Ratio (HR)|0.288||||0.397|TWO_SIDED|95.0|0.016|5.122|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 12q No versus Yes||5.122|0.016|0.397
74008688|NCT00718549|147567464|SUPERIORITY||Odds Ratio (OR)|0.982||||0.969|TWO_SIDED|95.0|0.393|2.531|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||2.531|0.393|0.969
74008689|NCT00718549|147567464|SUPERIORITY||Odds Ratio (OR)|0.552||||0.26|TWO_SIDED|95.0|0.183|1.488|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||1.488|0.183|0.260
74008690|NCT00718549|147567464|SUPERIORITY||Odds Ratio (OR)|0.465||||0.121|TWO_SIDED|95.0|0.177|1.242|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||1.242|0.177|0.121
74008691|NCT00718549|147567464|SUPERIORITY||Odds Ratio (OR)|0.374||||0.045|TWO_SIDED|95.0|0.137|0.957|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||0.957|0.137|0.045
74008692|NCT00718549|147567464|SUPERIORITY||Odds Ratio (OR)|8.809||||0.04|TWO_SIDED|95.0|1.655|163.316|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive||163.316|1.655|0.040
74008693|NCT00718549|147567464|SUPERIORITY||Odds Ratio (OR)|0.921||||0.887|TWO_SIDED|95.0|0.287|2.851|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||2.851|0.287|0.887
74008694|NCT00718549|147567464|SUPERIORITY||Odds Ratio (OR)|0.932||||0.936|TWO_SIDED|95.0|0.186|6.839|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes||6.839|0.186|0.936
74008695|NCT00718549|147567464|SUPERIORITY||Odds Ratio (OR)|1.88||||0.199|TWO_SIDED|95.0|0.719|5.012|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||5.012|0.719|0.199
74008696|NCT00718549|147567464|SUPERIORITY||Odds Ratio (OR)|1.668||||0.375|TWO_SIDED|95.0|0.566|5.649|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||5.649|0.566|0.375
74008697|NCT00718549|147567464|SUPERIORITY||Odds Ratio (OR)|0.957||||0.961|TWO_SIDED|95.0|0.173|7.275|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||7.275|0.173|0.961
74008698|NCT00718549|147567465|SUPERIORITY||Odds Ratio (OR)|1.31||||0.768|TWO_SIDED|95.0|0.237|10.189|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||10.189|0.237|0.768
74008699|NCT00718549|147567465|SUPERIORITY||Odds Ratio (OR)|0.667||||0.657|TWO_SIDED|95.0|0.086|3.653|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||3.653|0.086|0.657
74008700|NCT00718549|147567465|SUPERIORITY||Odds Ratio (OR)|1.68||||0.655|TWO_SIDED|95.0|0.229|34.486|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||34.486|0.229|0.655
74008701|NCT00718549|147567465|SUPERIORITY||Odds Ratio (OR)|0.635||||0.595|TWO_SIDED|95.0|0.117|3.73|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||3.730|0.117|0.595
74008702|NCT00718549|147567465|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.164|8.102|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive||8.102|0.164|1.000
74008703|NCT00718549|147567465|SUPERIORITY||Odds Ratio (OR)|0.857||||0.882|TWO_SIDED|95.0|0.093|6.636|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||6.636|0.093|0.882
74008704|NCT00718549|147567465|SUPERIORITY||Odds Ratio (OR)|0.154||||0.216|TWO_SIDED|95.0|0.005|4.405|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes||4.405|0.005|0.216
74008705|NCT00718549|147567465|SUPERIORITY||Odds Ratio (OR)|0.361||||0.396|TWO_SIDED|95.0|0.017|2.971|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||2.971|0.017|0.396
74008706|NCT00718549|147567465|SUPERIORITY||Odds Ratio (OR)|0.75||||0.776|TWO_SIDED|95.0|0.103|6.572|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||6.572|0.103|0.776
74008707|NCT00718549|147567466|SUPERIORITY||Odds Ratio (OR)|0.528||||0.357|TWO_SIDED|95.0|0.131|2.114|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||2.114|0.131|0.357
74008708|NCT00718549|147567466|SUPERIORITY||Odds Ratio (OR)|0.694||||0.623|TWO_SIDED|95.0|0.138|2.8|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||2.800|0.138|0.623
74036827|NCT01617655|147627031|SUPERIORITY_OR_OTHER||LS mean difference|-39.1|||<|0.0001|TWO_SIDED|95.0|-51.1|-27.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-27.1|-51.1|<0.0001
73877395|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-0.7||||0.942|TWO_SIDED|95.0|-20.87|19.4||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||19.40|-20.87|0.942
73877396|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-12.0||||0.162|TWO_SIDED|95.0|-28.89|4.91||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||4.91|-28.89|0.162
74036828|NCT01617655|147627032|SUPERIORITY_OR_OTHER||LS mean difference|-38.9|||<|0.0001|TWO_SIDED|95.0|-51.0|-26.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-26.9|-51|<0.0001
74036829|NCT01617655|147627033|SUPERIORITY_OR_OTHER||LS mean difference|-40.3|||<|0.0001|TWO_SIDED|95.0|-51.4|-29.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.3|-51.4|<0.0001
74036830|NCT01617655|147627034|SUPERIORITY_OR_OTHER||LS mean difference|-40.3|||<|0.0001|TWO_SIDED|95.0|-51.4|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.2|-51.4|<0.0001
74036831|NCT01617655|147627035|SUPERIORITY_OR_OTHER||LS mean difference|-30.3|||<|0.0001|TWO_SIDED|95.0|-39.7|-20.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.9|-39.7|<0.0001
73957057|NCT01078246|147450035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72||||0.125|TWO_SIDED|95.0|0.861|3.437|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 1st treatment regimen.||||3.437|0.861|0.125
73957058|NCT01078246|147450035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.056||||0.881|TWO_SIDED|95.0|0.517|2.155|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 2nd treatment regimen.||||2.155|0.517|0.881
73957059|NCT01078246|147450035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.077||||0.107|TWO_SIDED|95.0|0.854|5.05|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 3rd+ treatment regimen.||||5.05|0.854|0.107
73957060|NCT03593070|147450049|OTHER|Analyses compared changes in total scores for the MM-CGI from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.646|STANDARD_DEVIATION|0.622||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
73957061|NCT03593070|147450050|OTHER||Slope|0.444|STANDARD_DEVIATION|0.105||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||Analyses compared changes in total scores for the CESD from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).||||0.001
73957062|NCT03593070|147450051|OTHER|Analyses compared changes in total State Trait Anxiety Inventory (STAI) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.514|STANDARD_DEVIATION|0.102||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
73957063|NCT03593070|147450052|OTHER|Analyses compared changes in total positive state of mind scale (PSOMS) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.653|STANDARD_DEVIATION|0.093||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
73957064|NCT03593070|147450053|OTHER|Analyses compared changes in conflict scores (based on FPCR) from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.609|STANDARD_DEVIATION|0.07||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
73957065|NCT03593070|147450054|OTHER|Analyses compared changes in total scores for satisfaction with care measure (FPCT) from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.731|STANDARD_DEVIATION|0.074||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
73957066|NCT03593070|147450055|OTHER|Analyses compared changes in total Family Knowledge of Alzheimer's Test (FKAT) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.687|STANDARD_DEVIATION|0.084||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
74036832|NCT01617655|147627036|SUPERIORITY_OR_OTHER||LS mean difference|-30.2|||<|0.0001|TWO_SIDED|95.0|-39.7|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.7|-39.7|<0.0001
74036833|NCT01617655|147627037|SUPERIORITY_OR_OTHER||LS mean difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-46.3|-25.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.3|-46.3|<0.0001
74036834|NCT01617655|147627038|SUPERIORITY_OR_OTHER||LS mean difference|-35.5|||<|0.0001|TWO_SIDED|95.0|-46.2|-24.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.9|-46.2|<0.0001
74036835|NCT01617655|147627039|SUPERIORITY_OR_OTHER||LS mean difference|-28.4|||<|0.0001|TWO_SIDED|95.0|-37.3|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.6|-37.3|<0.0001
74036836|NCT01617655|147627040|SUPERIORITY_OR_OTHER||LS mean difference|-30.2|||<|0.0001|TWO_SIDED|95.0|-39.2|-21.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.1|-39.2|<0.0001
74000587|NCT02679573|147549713|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.5|||||TWO_SIDED|95.0|-4.8|5.9||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||5.9|-4.8|
74000588|NCT02679573|147549714|OTHER|||||||0.5951||||||The log-rank test was used to compare the time to all-cause mortality between the 2 treatment groups.|Log Rank|||||||0.5951
74000589|NCT01506609|147549715|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.227|TWO_SIDED|95.0|0.536|1.162|||Log Rank|||||1.162|0.536|0.227
73877397|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|10.9||||0.253|TWO_SIDED|95.0|-7.96|29.82||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||29.82|-7.96|0.253
74000590|NCT01506609|147549715|SUPERIORITY||Hazard Ratio (HR)|1.858||||0.001|TWO_SIDED|95.0|1.278|2.702|||Log Rank|||||2.702|1.278|0.001
74000591|NCT01506609|147549716|SUPERIORITY||Hazard Ratio (HR)|0.848||||0.368|TWO_SIDED|95.0|0.59|1.218|||Log Rank|||||1.218|0.590|0.368
74000592|NCT01506609|147549716|SUPERIORITY||Hazard Ratio (HR)|1.512||||0.017|TWO_SIDED|95.0|1.074|2.127|||Log Rank|||||2.127|1.074|0.017
74000593|NCT01506609|147549717|SUPERIORITY|||||||0.434||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.434
74000594|NCT01506609|147549717|SUPERIORITY|||||||0.019||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.019
74000595|NCT01506609|147549718|SUPERIORITY|||||||0.027||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.027
74000596|NCT01506609|147549718|SUPERIORITY||||||<|0.001||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||< 0.001
74000597|NCT01506609|147549719|SUPERIORITY||Least Squares (LS) Mean of Difference|-2.302|STANDARD_ERROR_OF_MEAN|2.476||0.354|TWO_SIDED|95.0|-7.2|2.6||ANCOVA with treatment arm and baseline value as covariate.|ANCOVA|||||2.60|-7.20|0.354
74000598|NCT01502631|147549720|SUPERIORITY||Least Squares (LS) Mean|5.61|STANDARD_ERROR_OF_MEAN|4.497||0.2182|TWO_SIDED|90.0|-1.93|13.14|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 2||13.14|-1.93|0.2182
74000599|NCT01502631|147549720|SUPERIORITY||Least Squares (LS) Mean|6.87|STANDARD_ERROR_OF_MEAN|5.583||0.226|TWO_SIDED|90.0|-2.54|16.27|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 4||16.27|-2.54|0.2260
74000600|NCT01502631|147549720|SUPERIORITY||Least Squares (LS) Mean|3.03|STANDARD_ERROR_OF_MEAN|6.023||0.6184|TWO_SIDED|90.0|-7.15|13.21|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 8||13.21|-7.15|0.6184
74000601|NCT01502631|147549720|SUPERIORITY||Least Squares (LS) Mean|4.54|STANDARD_ERROR_OF_MEAN|6.524||0.4912|TWO_SIDED|90.0|-6.48|15.56|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 16||15.56|-6.48|0.4912
74000602|NCT00395460|147549767|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was performed by means of a Confidence Interval (CI) approach: noninferiority of Gadavist was assumed if the one-sided 95% CI for pGadavist-pMagnevist was lying entirely to the right of the value -delta, where p is the estimated change in CNR and with pre-defined non-inferiority margin delta of 15% (=6.52 or 15% of 43.467).|Mean Difference (Final Values)|6.939|STANDARD_DEVIATION|38.83|||ONE_SIDED|95.0|-3.897||||non-inferiority||||||-3.897|
74000603|NCT00324116|147549798|SUPERIORITY_OR_OTHER||percent responders|85.0||||||95.0|76.0|95.0|||||Proportion of responders estimated by Kaplan-Meier analysis. Proportion of responders along with 95% CI calculated directly from estimate of survival distribution function. Percentage denominator = total number of subjects without missing data.|||95|76|
74000604|NCT00324116|147549799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.29||||||95.0|-6.83|-1.75|||||95% CI for the change in mean value obtained from one sample t-test.|6 weeks||-1.75|-6.83|
74000605|NCT00324116|147549799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.86||||||95.0|-9.06|-2.67|||||95% CI for the change in mean value obtained from one sample t-test.|12 weeks||-2.67|-9.06|
74000606|NCT00324116|147549799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.12||||||95.0|-16.28|-5.96|||||95% CI for the change in mean value obtained from one sample t-test.|54 weeks||-5.96|-16.28|
74000607|NCT00324116|147549800|SUPERIORITY_OR_OTHER||percentage of subjects|5.0||||||95.0|1.61|11.32|||||Proportion of subjects gaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations|||11.32|1.61|
74000608|NCT00324116|147549801|SUPERIORITY_OR_OTHER||percentage of subjects|22.5||||||95.0|14.22|32.11|||||Proportion of subjects maintaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||32.11|14.22|
74000609|NCT00324116|147549802|SUPERIORITY_OR_OTHER||percentage of subjects|13.75||||||95.0|7.39|22.24|||||Proportion of subjects with severe visual loss was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||22.24|7.39|
74000610|NCT00324116|147549803|SUPERIORITY_OR_OTHER||percentage of subjects|25.97||||||95.0|16.28|34.81|||||Proportion of subjects progressing to \<=20/200 was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||34.81|16.28|
74000611|NCT00116753|147549858|SUPERIORITY_OR_OTHER||Percentage of partcipants|78.3|||||TWO_SIDED|96.5|69.0|86.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||86|69|
74000612|NCT00116753|147549858|SUPERIORITY_OR_OTHER||Percentage of participants|79.5|||||TWO_SIDED|96.5|71.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||87|71|
74000613|NCT00116753|147549858|SUPERIORITY_OR_OTHER||Percentage of participants|85.3|||||TWO_SIDED|96.5|77.0|91.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||91|77|
74000614|NCT00116753|147549858|SUPERIORITY_OR_OTHER|||||||0.3022||95.0|||||Mantel Haenszel|||||||0.3022
74000615|NCT00116753|147549858|SUPERIORITY_OR_OTHER|||||||0.7797||95.0|||||Mantel Haenszel|||||||0.7797
74000616|NCT00116753|147549858|SUPERIORITY_OR_OTHER|||||||0.1557||95.0|||||Mantel Haenszel|||||||0.1557
74000617|NCT00116753|147549858|SUPERIORITY_OR_OTHER|||||||0.2208||95.0|||||Mantel Haenszel|||||||0.2208
74000618|NCT00116753|147549859|SUPERIORITY_OR_OTHER||Percentage of participants|80.7|||||TWO_SIDED|96.5|72.0|88.0|||||Estimated value is the percentage of participants with all testosterone values from after Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||88|72|
74000619|NCT00116753|147549859|SUPERIORITY_OR_OTHER||Percentage of participants|80.2|||||TWO_SIDED|96.5|72.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||87|72|
74000620|NCT00116753|147549859|SUPERIORITY_OR_OTHER||Percentage of participants|86.0|||||TWO_SIDED|96.5|78.0|92.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||92|78|
74000621|NCT00116753|147549859|SUPERIORITY_OR_OTHER|||||||0.383||95.0|||||Mantel Haenszel|||||||0.3830
74000622|NCT00116753|147549859|SUPERIORITY_OR_OTHER|||||||0.9587||95.0|||||Mantel Haenszel|||||||0.9587
74000623|NCT00116753|147549859|SUPERIORITY_OR_OTHER|||||||0.2579||95.0|||||Mantel Haenszel|||||||0.2579
74000624|NCT00116753|147549859|SUPERIORITY_OR_OTHER|||||||0.2072||95.0|||||Mantel Haenszel|||||||0.2072
74000625|NCT00116753|147549860|SUPERIORITY_OR_OTHER||Percentage of participants|97.3|||||TWO_SIDED|95.0|93.0|99.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||99|93|
73877398|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|5.5||||0.617|TWO_SIDED|95.0|-16.25|27.21||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||27.21|-16.25|0.617
73877399|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-6.0||||0.515|TWO_SIDED|95.0|-24.22|12.24||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||12.24|-24.22|0.515
73877400|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|13.8||||0.18|TWO_SIDED|95.0|-6.53|34.23||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||34.23|-6.53|0.180
73877401|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-0.4||||0.972|TWO_SIDED|95.0|-21.86|21.09||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||21.09|-21.86|0.972
73877402|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-4.9||||0.589|TWO_SIDED|95.0|-22.94|13.1||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||13.10|-22.94|0.589
74000626|NCT00116753|147549860|SUPERIORITY_OR_OTHER||Percentage of participants|97.9|||||TWO_SIDED|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||100|94|
73877403|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|14.1||||0.168|TWO_SIDED|95.0|-6.07|34.22||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||34.22|-6.07|0.168
74000627|NCT00116753|147549860|SUPERIORITY_OR_OTHER||Percentage of participants|97.9|||||TWO_SIDED|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||100|94|
74000628|NCT01445301|147549867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0|||<|0.001|TWO_SIDED|95.0|-15.0|-7.0|||ANCOVA|||||-7.0|-15.0|<0.001
74000629|NCT01445301|147549867|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.2|||<|0.001|TWO_SIDED|95.0|-12.9|-3.6|||ANCOVA|||||-3.6|-12.9|<0.001
74000630|NCT01445301|147549869|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.4|-1.5|||ANCOVA|||WEEK 1||-1.5|-4.4|<0.001
74000631|NCT01445301|147549869|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-1.8||||0.113|TWO_SIDED|95.0|-4.0|0.4|||ANCOVA|||WEEK 2||0.4|-4.0|0.113
74000632|NCT01445301|147549869|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.0||||0.084|TWO_SIDED|95.0|-4.2|0.3|||ANCOVA|||WEEK 4||0.3|-4.2|0.084
74000633|NCT01445301|147549869|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.7||||0.026|TWO_SIDED|95.0|-5.1|-0.3|||ANCOVA|||WEEK 8||-0.3|-5.1|0.026
74000634|NCT01445301|147549869|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.6||||0.03|TWO_SIDED|95.0|-5.0|-0.3|||ANCOVA|||WEEK 12||-0.3|-5.0|0.030
74000635|NCT01445301|147549869|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-3.4||||0.028|TWO_SIDED|95.0|-6.5|-0.4|||ANCOVA|||WEEK 1||-0.4|-6.5|0.028
74000636|NCT01445301|147549869|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.4||||0.004|TWO_SIDED|95.0|-9.1|-1.7|||ANCOVA|||WEEK 2||-1.7|-9.1|0.004
74000637|NCT01445301|147549869|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Odds Ratio (OR)|-5.8||||0.003|TWO_SIDED|95.0|-9.6|-1.9|||ANCOVA|||WEEK 4||-1.9|-9.6|0.003
74090733|NCT00361335|147735545|SUPERIORITY_OR_OTHER|||||||0.465||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups VII vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group VII at α = 0.05.||||0.465
73877404|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|1.9||||0.712|TWO_SIDED|95.0|-8.5|12.36||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||12.36|-8.50|0.712
73877405|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-2.3||||0.465|TWO_SIDED|95.0|-8.41|3.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||3.90|-8.41|0.465
73877406|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|0.3||||0.924|TWO_SIDED|95.0|-6.83|7.52||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||7.52|-6.83|0.924
74000638|NCT01445301|147549869|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.5||||0.006|TWO_SIDED|95.0|-9.4|-1.6|||ANCOVA|||WEEK 8||-1.6|-9.4|0.006
74000639|NCT01445301|147549869|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.6||||0.005|TWO_SIDED|95.0|-9.5|-1.7|||ANCOVA|||WEEK 12||-1.7|-9.5|0.005
74000640|NCT01445301|147549869|SUPERIORITY||Mean Difference (Net)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.9|-1.1|||ANCOVA|||WEEK 1||-1.1|-3.9|<0.001
74000641|NCT01445301|147549869|SUPERIORITY||Mean Difference (Net)|-3.2|||<|0.001|TWO_SIDED|95.0|-4.7|-1.6|||ANCOVA|||WEEK 2||-1.6|-4.7|<0.001
74000642|NCT01445301|147549869|SUPERIORITY||Mean Difference (Net)|-2.5||||0.002|TWO_SIDED|95.0|-4.1|-0.9|||ANCOVA|||WEEK 4||-0.9|-4.1|0.002
74000643|NCT01445301|147549869|SUPERIORITY||Mean Difference (Net)|-2.7||||0.003|TWO_SIDED|95.0|-4.5|-0.9|||ANCOVA|||WEEK 8||-0.9|-4.5|0.003
74090734|NCT00361335|147735545|SUPERIORITY_OR_OTHER|||||||0.872||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups II vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group II at α = 0.05.||||0.872
74000644|NCT01445301|147549869|SUPERIORITY||Mean Difference (Net)|-2.8||||0.002|TWO_SIDED|95.0|-4.6|-1.0|||ANCOVA|||WEEK 12||-1.0|-4.6|0.002
74000645|NCT01445301|147549869|SUPERIORITY||Mean Difference (Net)|-6.0|||<|0.001|TWO_SIDED|95.0|-8.8|-3.2|||ANCOVA|||WEEK 1||-3.2|-8.8|<0.001
74000646|NCT01445301|147549869|SUPERIORITY||Mean Difference (Net)|-8.1|||<|0.001|TWO_SIDED|95.0|-11.4|-4.7|||ANCOVA|||WEEK 2||-4.7|-11.4|<0.001
74000647|NCT01445301|147549869|SUPERIORITY||Mean Difference (Net)|-9.7|||<|0.001|TWO_SIDED|95.0|-13.1|-6.2|||ANCOVA|||WEEK 4||-6.2|-13.1|<0.001
74000648|NCT01445301|147549869|SUPERIORITY||Mean Difference (Net)|-8.6|||<|0.001|TWO_SIDED|95.0|-12.1|-5.1|||ANCOVA|||WEEK 8||-5.1|-12.1|<0.001
74000649|NCT01445301|147549869|SUPERIORITY||Mean Difference (Net)|-8.2|||<|0.001|TWO_SIDED|95.0|-11.6|-4.8|||ANCOVA|||WEEK 12||-4.8|-11.6|<0.001
74000650|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.71|||<|0.001|TWO_SIDED|95.0|-11.3|-4.12|||ANCOVA|||Total Lesion Counts, WEEK 1||-4.12|-11.30|<0.001
74000651|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.51|||<|0.001|TWO_SIDED|95.0|-13.24|-3.77|||ANCOVA|||Total Lesion Counts, WEEK 2||-3.77|-13.24|<0.001
74000652|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.89|||<|0.001|TWO_SIDED|95.0|-13.37|-4.41|||ANCOVA|||Total Lesion Counts, WEEK 4||-4.41|-13.37|<0.001
74000653|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.12|||<|0.001|TWO_SIDED|95.0|-13.82|-4.43|||ANCOVA|||Total Lesion Counts, WEEK 8||-4.43|-13.82|<0.001
74000654|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.43|||<|0.001|TWO_SIDED|95.0|-14.11|-4.75|||ANCOVA|||Total Lesion Counts, WEEK 12||-4.75|-14.11|<0.001
74000655|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-10.54|||<|0.001|TWO_SIDED|95.0|-15.12|-5.97|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1||-5.97|-15.12|<0.001
74000656|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.21||||0.011|TWO_SIDED|95.0|-12.73|-1.69|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2||-1.69|-12.73|0.011
74000657|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-7.64||||0.005|TWO_SIDED|95.0|-12.93|-2.35|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4||-2.35|-12.93|0.005
74008709|NCT00718549|147567466|SUPERIORITY||Odds Ratio (OR)|4.0||||0.097|TWO_SIDED|95.0|0.901|28.158|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||28.158|0.901|0.097
74000658|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.73||||0.002|TWO_SIDED|95.0|-14.2|-3.26|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8||-3.26|-14.20|0.002
74000659|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.2||||0.002|TWO_SIDED|95.0|-13.34|-3.06|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12||-3.06|-13.34|0.002
74000660|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-5.8||||0.011|TWO_SIDED|95.0|-10.29|-1.32|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1||-1.32|-10.29|0.011
74000661|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.3||||0.005|TWO_SIDED|95.0|-14.1|-2.5|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2||-2.50|-14.10|0.005
74000662|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.27|||<|0.001|TWO_SIDED|95.0|-14.72|-3.83|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4||-3.83|-14.72|<0.001
74000663|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.84||||0.002|TWO_SIDED|95.0|-14.28|-3.39|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8||-3.39|-14.28|0.002
74000664|NCT01445301|147549870|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.68|||<|0.001|TWO_SIDED|95.0|-15.06|-4.3|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12||-4.30|-15.06|<0.001
74000665|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-12.32|-5.48|||ANCOVA|||Total Lesion Counts, WEEK 1||-5.48|-12.32|<0.001
74000666|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-11.17|||<|0.001|TWO_SIDED|95.0|-15.18|-7.16|||ANCOVA|||Total Lesion Counts, WEEK 2||-7.16|-15.18|<0.001
74000667|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-12.12|||<|0.001|TWO_SIDED|95.0|-15.9|-8.35|||ANCOVA|||Total Lesion Counts, WEEK 4||-8.35|-15.90|<0.001
74000668|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-11.33|||<|0.001|TWO_SIDED|95.0|-15.37|-7.3|||ANCOVA|||Total Lesion Counts, WEEK 8||-7.30|-15.37|<0.001
74000669|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-11.18|||<|0.001|TWO_SIDED|95.0|-15.11|-7.25|||ANCOVA|||Total Lesion Counts, WEEK 12||-7.25|-15.11|<0.001
74000670|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-8.32|||<|0.001|TWO_SIDED|95.0|-12.76|-3.88|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1||-3.88|-12.76|<0.001
74000671|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-9.57|||<|0.001|TWO_SIDED|95.0|-13.83|-5.3|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2||-5.30|-13.83|<0.001
74000672|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-7.83|||<|0.001|TWO_SIDED|95.0|-12.03|-3.62|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4||-3.62|-12.03|<0.001
74000673|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-8.08|||<|0.001|TWO_SIDED|95.0|-12.63|-3.53|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8||-3.53|-12.63|<0.001
74000674|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-8.56|||<|0.001|TWO_SIDED|95.0|-12.71|-4.41|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12||-4.41|-12.71|<0.001
74000675|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-9.11|||<|0.001|TWO_SIDED|95.0|-13.53|-4.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1||-4.68|-13.53|<0.001
74000676|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-11.05|||<|0.001|TWO_SIDED|95.0|-16.3|-5.8|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2||-5.80|-16.30|<0.001
74000677|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-14.17|||<|0.001|TWO_SIDED|95.0|-18.97|-9.37|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4||-9.37|-18.97|<0.001
74000678|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-13.04|||<|0.001|TWO_SIDED|95.0|-17.83|-8.25|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8||-8.25|-17.83|<0.001
74000679|NCT01445301|147549870|SUPERIORITY||Mean Difference (Net)|-12.37|||<|0.001|TWO_SIDED|95.0|-17.05|-7.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12||-7.68|-17.05|<0.001
74000680|NCT01445301|147549871|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
74000681|NCT01445301|147549871|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
74000682|NCT01445301|147549872|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 1||||0.470
74000683|NCT01445301|147549872|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 2||||0.844
74000684|NCT01445301|147549872|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 4||||0.022
74000685|NCT01445301|147549872|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 8||||<0.001
74000686|NCT01445301|147549872|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 12||||<0.001
73877407|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|0.4||||0.938|TWO_SIDED|95.0|-8.88|9.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||9.60|-8.88|0.938
73877408|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|2.2||||0.41|TWO_SIDED|95.0|-3.17|7.64||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||7.64|-3.17|0.410
73877409|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|0.2||||0.941|TWO_SIDED|95.0|-5.89|6.35||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||6.35|-5.89|0.941
73877410|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|0.7||||0.872|TWO_SIDED|95.0|-8.23|9.67||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||9.67|-8.23|0.872
73877411|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-1.0||||0.692|TWO_SIDED|95.0|-6.27|4.2||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||4.20|-6.27|0.692
74000687|NCT01445301|147549872|SUPERIORITY_OR_OTHER|||||||0.572||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 1||||0.572
73877412|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-0.4||||0.896|TWO_SIDED|95.0|-6.32|5.54||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||5.54|-6.32|0.896
73877413|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|1.0||||0.826|TWO_SIDED|95.0|-7.92|9.87||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||9.87|-7.92|0.826
73877414|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|0.4||||0.885|TWO_SIDED|95.0|-4.82|5.58||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||5.58|-4.82|0.885
73957067|NCT03593070|147450056|OTHER||Slope|0.527|STANDARD_DEVIATION|0.088||0.001|TWO_SIDED|||||A prior alpha=0.05.|Regression, Linear|||Analyses compared changes in caregiver sense of loss, guilt, and role captivity scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT). This measure uses 51 items of the FPCR measure.||||0.001
73957068|NCT02197234|147450058|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|77.08|||||TWO_SIDED|90.0|63.41|93.7|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.||93.70|63.41|
73957069|NCT02197234|147450059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|91.46|||||TWO_SIDED|90.0|77.16|108.41|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.||108.41|77.16|
73957070|NCT01543685|147450065|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|441.8|STANDARD_ERROR_OF_MEAN|129.6|<|0.001|TWO_SIDED|95.0|187.1|696.5|||ANCOVA|||||696.5|187.1|<0.001
73957071|NCT01543685|147450065|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|260.2|STANDARD_ERROR_OF_MEAN|130.3||0.046|TWO_SIDED|95.0|4.1|516.3|||ANCOVA|||||516.3|4.1|0.046
73877415|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-0.1||||0.964|TWO_SIDED|95.0|-6.03|5.76||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||5.76|-6.03|0.964
73877416|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|1.1||||0.806|TWO_SIDED|95.0|-7.59|9.72||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||9.72|-7.59|0.806
73957072|NCT01543685|147450065|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|312.7|STANDARD_ERROR_OF_MEAN|130.4||0.017|TWO_SIDED|95.0|56.6|568.9|||ANCOVA|||||568.9|56.6|0.017
73957073|NCT01543685|147450065|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|211.6|STANDARD_ERROR_OF_MEAN|129.6||0.103|TWO_SIDED|95.0|-43.1|466.2|||ANCOVA|||||466.2|-43.1|0.103
73957074|NCT01543685|147450066|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|||||||0.013
73957075|NCT01543685|147450066|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
73957076|NCT01543685|147450066|SUPERIORITY_OR_OTHER|||||||0.211||95.0|||||t-test, 2 sided|||||||0.211
74000688|NCT01445301|147549872|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 2||||0.335
73957077|NCT01543685|147450066|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||t-test, 2 sided|||||||0.098
73957078|NCT01543685|147450067|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
73957079|NCT01543685|147450067|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
73957080|NCT01543685|147450067|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
73957081|NCT01543685|147450067|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|||||||0.028
73957082|NCT01543685|147450068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73957083|NCT01543685|147450068|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
73957084|NCT01543685|147450068|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
73957085|NCT01543685|147450068|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
73957086|NCT01543685|147450069|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
73957087|NCT01543685|147450069|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||||||0.022
73957088|NCT01543685|147450069|SUPERIORITY_OR_OTHER|||||||0.146||95.0|||||t-test, 2 sided|||||||0.146
73957089|NCT01543685|147450069|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|||||||0.071
73957090|NCT01543685|147450070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73957091|NCT01543685|147450070|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
73957092|NCT01543685|147450070|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.010
73957093|NCT01543685|147450070|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
73957094|NCT01543685|147450071|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73957095|NCT01543685|147450071|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
73957096|NCT01543685|147450071|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
73957097|NCT01543685|147450071|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
73957098|NCT01543685|147450072|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73957099|NCT01543685|147450072|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.020
73957100|NCT01543685|147450072|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|||||||0.012
73957101|NCT01543685|147450072|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||t-test, 2 sided|||||||0.029
73957102|NCT02931396|147450083|SUPERIORITY||Mean Difference (Net)|2.3||||0.768|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.768
73957103|NCT02931396|147450084|SUPERIORITY||Mean Difference (Net)|25.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1
73957104|NCT02931396|147450085|SUPERIORITY||Mean Difference (Net)|2.7||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
73957105|NCT04341298|147450108|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
73957106|NCT04341298|147450109|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
73957107|NCT04341298|147450110|SUPERIORITY|||||||0.66|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects with a pain score of 3 or less after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting mild or no symptoms after 2 hours and the type of device, across all strata.||||0.66
73957108|NCT04341298|147450111|SUPERIORITY|||||||0.59|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects requiring abortive medication within 8 hours were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects requiring abortive medication within 8 hours and the type of device, across all strata.||||0.59
73957109|NCT04341298|147450112|SUPERIORITY|||||||0.19|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 2 hours and the type of device, across all strata.||||0.19
73877417|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|0.4||||0.871|TWO_SIDED|95.0|-4.65|5.47||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||5.47|-4.65|0.871
73877418|NCT02365649|147294863|SUPERIORITY||LS Mean of Difference|-0.5||||0.85|TWO_SIDED|95.0|-6.28|5.19||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||5.19|-6.28|0.850
73877419|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|-3.9||||0.792|TWO_SIDED|95.0|-33.73|25.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||25.90|-33.73|0.792
73877420|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|18.1||||0.179|TWO_SIDED|95.0|-8.62|44.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||44.75|-8.62|0.179
73877421|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|-19.1||||0.23|TWO_SIDED|95.0|-50.87|12.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||12.63|-50.87|0.230
73877422|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|16.4||||0.337|TWO_SIDED|95.0|-17.54|50.4||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||50.40|-17.54|0.337
73877423|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|1.1||||0.924|TWO_SIDED|95.0|-21.75|23.93||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||23.93|-21.75|0.924
74000689|NCT01445301|147549872|SUPERIORITY_OR_OTHER|||||||0.187||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 4||||0.187
73877424|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|-11.7||||0.373|TWO_SIDED|95.0|-37.69|14.35||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||14.35|-37.69|0.373
74000690|NCT01445301|147549872|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 8||||<0.001
74000691|NCT01445301|147549872|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 12||||0.006
74000692|NCT01445301|147549873|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 1||||0.002
74000693|NCT01445301|147549873|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 2||||<0.001
74000694|NCT01445301|147549873|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 4||||<0.001
74000695|NCT01445301|147549873|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 8||||<0.001
74000696|NCT01445301|147549873|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 12||||<0.001
74000697|NCT01445301|147549873|SUPERIORITY_OR_OTHER|||||||0.48|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 1||||0.480
74000698|NCT01445301|147549873|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 2||||<0.001
74000699|NCT01445301|147549873|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 4||||0.009
73877425|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|-3.1||||0.813|TWO_SIDED|95.0|-28.94|22.79||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||22.79|-28.94|0.813
73877426|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|5.3||||0.651|TWO_SIDED|95.0|-18.02|28.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||28.65|-18.02|0.651
73877427|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|-23.8||||0.065|TWO_SIDED|95.0|-49.12|1.49||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||1.49|-49.12|0.065
73877428|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|5.3||||0.802|TWO_SIDED|95.0|-37.61|48.28||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||48.28|-37.61|0.802
73877429|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|0.6||||0.955|TWO_SIDED|95.0|-20.46|21.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||21.63|-20.46|0.955
73877430|NCT02365649|147294864|SUPERIORITY||LS Mean of Difference|-10.6||||0.395|TWO_SIDED|95.0|-35.73|14.47||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||14.47|-35.73|0.395
73877431|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|-0.0082||||0.893|TWO_SIDED|95.0|-0.1299|0.1136||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||0.1136|-0.1299|0.893
73957110|NCT04341298|147450113|SUPERIORITY|||||||1|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 4 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 4 hours and the type of device, across all strata.||||1.0
73957111|NCT04341298|147450114|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|Pain score difference after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that 2 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.021
73877432|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|0.0685||||0.182|TWO_SIDED|95.0|-0.0334|0.1705||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||0.1705|-0.0334|0.182
73877433|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|-0.1323||||0.036|TWO_SIDED|95.0|-0.2552|-0.0093||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders||-0.0093|-0.2552|0.036
73957112|NCT04341298|147450115|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|Pain score difference after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that 4 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.019
73877434|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|0.0768||||0.316|TWO_SIDED|95.0|-0.0749|0.2286||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.2286|-0.0749|0.316
73957113|NCT04341298|147450116|SUPERIORITY|Null hypothesis is that proportion of headaches with light sensitivity experienced after 2 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||||0.028|||||||Mixed Models Analysis|Proportion of headaches with light sensitivity after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.||||||0.028
73957114|NCT04341298|147450117|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Proportion of headaches with light sensitivity after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that proportion of headaches with light sensitivity experienced after 4 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.46
73957115|NCT01257503|147450139|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in same participant||change in runny nose||||.86
73957116|NCT01257503|147450139|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in sneeze||||.89
73957117|NCT01257503|147450139|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in cough||||.45
73957118|NCT01257503|147450139|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in congestion||||.82
73957119|NCT01257503|147450140|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in irritability||||.61
73957120|NCT01257503|147450140|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in lethargy||||.97
73957121|NCT01257503|147450140|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in fussiness||||.79
73957122|NCT01257503|147450140|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in appetite||||.81
73957123|NCT01257503|147450141|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 1||||.16
73957124|NCT01257503|147450141|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 2||||.70
73957125|NCT01257503|147450141|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 3||||.77
73957126|NCT01257503|147450141|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status at 7-10 day follow-up||||.41
73957127|NCT01257503|147450142|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 1||||.10
73957128|NCT01257503|147450142|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 2||||.28
73957129|NCT01257503|147450142|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 3||||.26
73957130|NCT01257503|147450142|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status at follow-up||||.88
73957131|NCT01257503|147450143|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 1||||.02
73957132|NCT01257503|147450143|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 2||||.01
73957133|NCT01257503|147450143|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||day 2 assessment 1||||.25
73957134|NCT01257503|147450143|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 2 assessment 2||||.15
73957135|NCT01257503|147450143|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 1||||.88
73957136|NCT01257503|147450143|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 2||||.35
73957137|NCT01257503|147450143|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score at 7-10 day follow-up||||.36
73957138|NCT02657629|147450144|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
73957139|NCT02987543|147450145|SUPERIORITY||Odds Ratio (OR)|20.86|||<|0.0001|TWO_SIDED|95.0|4.18|379.18|||Regression, Logistic|||||379.18|4.18|<0.0001
73957140|NCT02987543|147450146|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.38|0.63|||Regression, Cox|||||0.63|0.38|<0.0001
73957141|NCT02987543|147450147|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0192|TWO_SIDED|95.0|0.22|0.91|||Regression, Cox|||||0.91|0.22|0.0192
73957142|NCT02987543|147450148|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0175|TWO_SIDED|95.0|0.5|0.97||2-sided p-value|Regression, Cox|||||0.97|0.50|0.0175
73957143|NCT02987543|147450149|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.25|0.47|||Regression, Cox|||||0.47|0.25|<0.0001
73957144|NCT01803646|147450186|SUPERIORITY||Mean Difference (Net)|-0.17||||0.32|TWO_SIDED|95.0|-0.51|0.17|||Mixed Models Analysis|||||0.17|-0.51|0.32
73957145|NCT01803646|147450187|SUPERIORITY||Mean Difference (Net)|-0.79||||0.63|TWO_SIDED|95.0|-4.0|2.4|||Mixed Models Analysis|||||2.4|-4|0.63
73957146|NCT01803646|147450188|SUPERIORITY|||||||0.821|||||||Fisher Exact|||Analysis for air conduction||||0.821
73957147|NCT01803646|147450188|SUPERIORITY|||||||1|||||||Fisher Exact|||Analysis for bone conduction||||1.0
73957148|NCT01368406|147450239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.055|TWO_SIDED|95.0|-0.65|1.13|||t-test, 2 sided|t test for independent samples||||1.13|-0.65|0.055
73957149|NCT01368406|147450239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.055|TWO_SIDED|95.0|0.13|0.83|||t-test, 2 sided|||||0.83|0.13|0.055
73957150|NCT04304534|147450252|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.052|||=|0.8439|TWO_SIDED|90.0|0.687|1.612|||Log Rank|||Comparison of the Asundexian 20 mg group and 50 mg group versus Placebo group||1.612|0.687|= 0.8439
73957151|NCT04304534|147450252|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.096|||=|0.7562|TWO_SIDED|90.0|0.674|1.781|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||1.781|0.674|= 0.7562
73957152|NCT04304534|147450252|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.008|||=|0.978|TWO_SIDED|90.0|0.614|1.656|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||1.656|0.614|= 0.978
73957153|NCT04304534|147450253|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.98|||=|0.9158|TWO_SIDED|90.0|0.713|1.347|||Log Rank|||Comparison of the Pooled Asundexian group versus Placebo group||1.347|0.713|= 0.9158
73957154|NCT04304534|147450253|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.867|||=|0.5633|TWO_SIDED|90.0|0.577|1.302|||Log Rank|||Comparison of the Asundexian 10 mg group versus Placebo group||1.302|0.577|= 0.5633
73957155|NCT04304534|147450253|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.875|||=|0.584|TWO_SIDED|90.0|0.587|1.306|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||1.306|0.587|= 0.584
73957156|NCT04304534|147450253|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|1.202|||=|0.417|TWO_SIDED|90.0|0.828|1.747|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||1.747|0.828|= 0.417
73877435|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|0.0573||||0.277|TWO_SIDED|95.0|-0.0471|0.1617||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.1617|-0.0471|0.277
73877436|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|0.0428||||0.467|TWO_SIDED|95.0|-0.0741|0.1597||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.1597|-0.0741|0.467
73877437|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|-0.036||||0.464|TWO_SIDED|95.0|-0.1336|0.0616||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||0.0616|-0.1336|0.464
73877438|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|0.0404||||0.345|TWO_SIDED|95.0|-0.0444|0.1252||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||0.1252|-0.0444|0.345
74000700|NCT01445301|147549873|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 8||||0.008
74000701|NCT01445301|147549873|SUPERIORITY_OR_OTHER|||||||0.065|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 12||||0.065
74000702|NCT01090427|147549894|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
74000703|NCT01090427|147549894|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
74000704|NCT01090427|147549895|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
74000705|NCT01090427|147549895|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
74000706|NCT01090427|147549896|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] will be used as factors in the model.||||||0.003
74000707|NCT01090427|147549896|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] will be used as factors in the model.||||||<0.001
74036837|NCT01617655|147627041|SUPERIORITY_OR_OTHER||LS mean difference|-34.5|||<|0.0001|TWO_SIDED|95.0|-44.8|-24.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.1|-44.8|<0.0001
73877439|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|-0.0873||||0.071|TWO_SIDED|95.0|-0.1822|0.0076||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||0.0076|-0.1822|0.071
74000708|NCT01090427|147549897|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
74000709|NCT01090427|147549897|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
74000710|NCT01090427|147549898|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0||||<0.001
74000711|NCT01090427|147549898|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0||||<0.001
74000712|NCT01090427|147549898|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2||||<0.001
74000713|NCT01090427|147549898|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2||||<0.001
74000714|NCT01090427|147549899|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders||||<0.001
74000715|NCT01090427|147549899|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders||||<0.001
74000716|NCT01090427|147549899|SUPERIORITY_OR_OTHER|||||||0.014|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0||||0.014
74000717|NCT01090427|147549899|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0||||<0.001
74036838|NCT01617655|147627042|SUPERIORITY_OR_OTHER||LS mean difference|-27.8|||<|0.0001|TWO_SIDED|95.0|-36.2|-19.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.4|-36.2|<0.0001
74036839|NCT01617655|147627043|SUPERIORITY_OR_OTHER||LS mean difference|-39.1|||<|0.0001|TWO_SIDED|95.0|-53.6|-24.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.6|-53.6|<0.0001
73877440|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|0.1109||||0.317|TWO_SIDED|95.0|-0.1109|0.3326||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.3326|-0.1109|0.317
73877441|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|0.0848||||0.125|TWO_SIDED|95.0|-0.0248|0.1945||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.1945|-0.0248|0.125
73877442|NCT02365649|147294865|SUPERIORITY||LS Mean of Difference|0.0559||||0.39|TWO_SIDED|95.0|-0.0745|0.1864||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.1864|-0.0745|0.390
74000718|NCT01090427|147549900|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Total Scale Score||||0.003
74000719|NCT01090427|147549900|SUPERIORITY_OR_OTHER|||||||0.028|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Total Scale Score||||0.028
74000720|NCT01090427|147549900|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Psychosocial health summary score||||0.005
74000721|NCT01090427|147549900|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Psychosocial health summary score||||0.063
74090735|NCT00361335|147735545|SUPERIORITY_OR_OTHER|||||||0.175||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the combined group (I and III) at α = 0.05.||||0.175
74090736|NCT00361335|147735546|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VI at 0.05 level of significance.||||0.002
74090737|NCT00361335|147735546|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups I vs V at 0.05 level of significance.||||0.032
74090738|NCT00361335|147735546|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups III vs V at 0.05 level of significance.||||<0.001
74090739|NCT00361335|147735546|SUPERIORITY_OR_OTHER|||||||0.795||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VII at 0.05 level of significance.||||0.795
74090740|NCT00361335|147735546|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups II vs V at 0.05 level of significance.||||0.844
74090741|NCT00361335|147735546|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.540
74090742|NCT00361335|147735547|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||<0.001
74090743|NCT00361335|147735547|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||<0.001
74090744|NCT00361335|147735547|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||<0.001
74090745|NCT00361335|147735547|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VII at 0.05 level of significance.||||0.002
74090746|NCT00361335|147735547|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.043
74090747|NCT00361335|147735547|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||<0.001
74090748|NCT00361335|147735548|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||<0.001
73877443|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|8.7||||0.263|TWO_SIDED|95.0|-6.79|24.16||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||24.16|-6.79|0.263
74090749|NCT00361335|147735548|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||<0.001
74090750|NCT00361335|147735548|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||<0.001
74090751|NCT00361335|147735548|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VII at 0.05 level of significance.||||<0.001
74090752|NCT00361335|147735548|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.003
74090753|NCT00361335|147735548|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|No adjustments were made to control for multiplicity||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.001
74090754|NCT00361335|147735549|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||0.005
73957157|NCT04304534|147450254|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.275|||||TWO_SIDED|90.0|0.322|5.05||||||Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group||5.050|0.322|
73957158|NCT04304534|147450254|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.991|||||TWO_SIDED|90.0|0.479|8.273||||||Comparison of the Asundexian 50 mg group versus Placebo group||8.273|0.479|
73957159|NCT04304534|147450255|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.125|||||TWO_SIDED|90.0|0.696|1.819||||||Comparison of the Asundexian 20 mg group and Asundexian 50 mg versus Placebo group||1.819|0.696|
73957160|NCT04304534|147450255|OTHER||Cox Proportional Hazard|1.181|||||TWO_SIDED|90.0|0.686|2.031||||||Comparison of the Asundexian 20 mg group versus Placebo group||2.031|0.686|
73957161|NCT04304534|147450255|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.07|||||TWO_SIDED|90.0|0.613|1.866||||||Comparison of the Asundexian 50 mg group versus Placebo group||1.866|0.613|
73957162|NCT04304534|147450258|OTHER|For all-cause mortality there is no competing event.|Cox Proportional Hazard|1.266|||=|0.6016|TWO_SIDED|90.0|0.603|2.658|||Log Rank|||Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group||2.658|0.603|= 0.6016
73957163|NCT04304534|147450258|OTHER||Cox Proportional Hazard|0.996|||=|0.9945|TWO_SIDED|90.0|0.414|2.401|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||2.401|0.414|= 0.9945
73957164|NCT04304534|147450258|OTHER||Cox Proportional Hazard|1.506|||=|0.4085|TWO_SIDED|90.0|0.667|3.405|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||3.405|0.667|= 0.4085
73957165|NCT01466881|147450266|SUPERIORITY_OR_OTHER|||||||0.2316|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided alpha level of 0.05||The null hypothesis is that there is no significant difference in Aurora kinase A expression between responders and non-responders.||||0.2316
73957166|NCT01970943|147450289|OTHER||Mean Difference (Final Values)|0.6078||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
73957167|NCT01970943|147450291|OTHER||Mean Difference (Final Values)|0.037786||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||.05
73957168|NCT01972152|147450293|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis.||||||0.24
73957169|NCT01972152|147450294|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||0.34
73957170|NCT01972152|147450294|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||0.01
73957171|NCT01972152|147450295|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.95
73957172|NCT01972152|147450296|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Mixed Models Analysis|||||||0.76
73957173|NCT01972152|147450297|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
73957174|NCT01972152|147450297|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
73957175|NCT01972152|147450298|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||0.16
73957176|NCT01972152|147450299|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
73957177|NCT01972152|147450299|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
73957178|NCT01972152|147450300|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
73957179|NCT01972152|147450300|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||<0.001
73957180|NCT01972152|147450301|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73957181|NCT01972152|147450301|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73957182|NCT02512042|147450302|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 (hours 0, before the morning drop) at the Day 14 visit should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.36|||||TWO_SIDED|95.0|-0.69|-0.03||||||||-0.03|-0.69|
73957183|NCT02512042|147450302|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/- 1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.43|0.22||||||||0.22|-0.43|
73957184|NCT02512042|147450302|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 14 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-0.71|-0.09||||||||-0.09|-0.71|
74000722|NCT01090427|147549900|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Physical health summary score||||0.007
74036840|NCT01617655|147627044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.7||||0.0016|TWO_SIDED|95.0|2.5|53.5||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||53.5|2.5|0.0016
74000723|NCT01090427|147549900|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Physical health summary score||||0.020
74000724|NCT01090427|147549901|SUPERIORITY_OR_OTHER|||||||0.027|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||0.027
74000725|NCT01090427|147549901|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
74000726|NCT01200589|147549902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.89|1.49||||||||1.49|0.89|
74000727|NCT03143166|147549967|OTHER||Adjusted gMean ratio Test/Reference (%)|28.85|STANDARD_ERROR_OF_MEAN|86.7|||TWO_SIDED|90.0|21.346|38.996|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||38.996|21.346|
74000728|NCT03143166|147549968|OTHER||Adjusted gMean ratio Test/Reference (%)|26.37|STANDARD_ERROR_OF_MEAN|76.6|||TWO_SIDED|90.0|20.066|34.665|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||34.665|20.066|
74000729|NCT03143166|147549969|OTHER||Adjusted gMean ratio Test/Reference (%)|28.02|STANDARD_ERROR_OF_MEAN|83.4|||TWO_SIDED|90.0|20.914|37.537|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||37.537|20.914|
74090755|NCT00361335|147735549|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||0.014
74000730|NCT03143166|147549970|OTHER||Adjusted gMean ratio Test/Reference (%)|27.56|STANDARD_ERROR_OF_MEAN|75.6|||TWO_SIDED|90.0|21.023|36.118|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||36.118|21.023|
74000731|NCT03143166|147549971|OTHER||Adjusted gMean ratio Test/Reference (%)|30.59|STANDARD_ERROR_OF_MEAN|76.8|||TWO_SIDED|90.0|23.26|40.234|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||40.234|23.260|
74000732|NCT03143166|147549972|OTHER||Adjusted gMean ratio Test/Reference (%)|30.61|STANDARD_ERROR_OF_MEAN|74.9|||TWO_SIDED|90.0|23.404|40.037|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||40.037|23.404|
74000733|NCT01323972|147549982|OTHER||GMT ratio|1.32|||||TWO_SIDED|95.0|1.06|1.65|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 2 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.65|1.06|
74000734|NCT01323972|147549982|OTHER||GMT ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.32|0.85|
74000735|NCT01323972|147549982|OTHER||GMT ratio|0.8||||||95.0|0.64|1.0|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 2 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1|0.64|
74000736|NCT01323972|147549982|NON_INFERIORITY|Non-inferiority was demonstrated if one month post Dose 3, the upper limit (UL) of the 2-sided 95% CI of the GMT ratio of the pilot scale lot (Control Group) over the pooled commercial scale lots (Pooled Log Group) was below 2.|GMT ratio|0.95||||||95.0|0.79|1.15||||||Demonstration of non-inferiority of the commercial scale lots of GSK 257049 to the pilot scale lot in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.15|0.79|
74000737|NCT00910689|147550035|SUPERIORITY_OR_OTHER||||||<|0.01||||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family-wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus Test: A mixed model with fixed effects for treatment,natural time(defined as natural log of months) and treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects(using the PROC MIXED procedure in SAS statistical software,version 9;www.sas.com). A significant treatment by time interaction(p \< .05, 2-tailed) was followed by post-tests (see below). Details of significant post tests are reported as separate analyses.||||< .01
74036841|NCT01617655|147627045|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.9||||0.0014|TWO_SIDED|95.0|2.6|54.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||54.9|2.6|0.0014
74090756|NCT00361335|147735549|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||0.014
73877444|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|15.2||||0.031|TWO_SIDED|95.0|1.47|28.93||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders||28.93|1.47|0.031
73877445|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|-12.0||||0.135|TWO_SIDED|95.0|-27.93|3.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||3.90|-27.93|0.135
73877446|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|6.3||||0.458|TWO_SIDED|95.0|-10.61|23.27||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||23.27|-10.61|0.458
73877447|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|1.9||||0.738|TWO_SIDED|95.0|-9.59|13.45||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||13.45|-9.59|0.738
73877448|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|-5.4||||0.412|TWO_SIDED|95.0|-18.32|7.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||7.60|-18.32|0.412
73877449|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|3.9||||0.534|TWO_SIDED|95.0|-8.56|16.36||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||16.36|-8.56|0.534
73877450|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|11.0||||0.052|TWO_SIDED|95.0|-0.1|22.01||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||22.01|-0.10|0.052
74000738|NCT00910689|147550035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_DEVIATION|0.57|<|0.001||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
74000739|NCT00910689|147550035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.68|>|0.25|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||> .25
73877451|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|-13.9||||0.027|TWO_SIDED|95.0|-26.15|-1.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders||-1.63|-26.15|0.027
73877452|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|-1.0||||0.928|TWO_SIDED|95.0|-24.02|21.97||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||21.97|-24.02|0.928
73877453|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|-2.5||||0.658|TWO_SIDED|95.0|-13.72|8.77||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||8.77|-13.72|0.658
73877454|NCT02365649|147294866|SUPERIORITY||LS Mean of Difference|-3.5||||0.601|TWO_SIDED|95.0|-16.96|9.96||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||9.96|-16.96|0.601
74000740|NCT00910689|147550035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.59|>|0.98|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .98
74000741|NCT00910689|147550035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.69|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
74000742|NCT00910689|147550035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.61|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
74000743|NCT00910689|147550035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.72|>|0.29|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.29
74008710|NCT00718549|147567466|SUPERIORITY||Odds Ratio (OR)|4.2||||0.233|TWO_SIDED|95.0|0.484|89.588|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||89.588|0.484|0.233
74008711|NCT00718549|147567466|SUPERIORITY||Odds Ratio (OR)|0.844||||0.826|TWO_SIDED|95.0|0.161|3.681|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||3.681|0.161|0.826
74008712|NCT00718549|147567466|SUPERIORITY||Odds Ratio (OR)|1.067||||0.933|TWO_SIDED|95.0|0.246|5.581|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||5.581|0.246|0.933
74008713|NCT00718549|147567466|SUPERIORITY||Odds Ratio (OR)|0.727||||0.794|TWO_SIDED|95.0|0.08|15.779|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||15.779|0.080|0.794
74090757|NCT00361335|147735549|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I and VII at 0.05 level of significance.||||0.996
74090758|NCT00361335|147735549|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.738
74090759|NCT00361335|147735549|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||No adjustments were made to control for multiplicity|2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.788
74090760|NCT01765582|147735564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.132|TWO_SIDED|90.0|0.96|2.71|||Cochran-Mantel-Haenszel|||Stratified by extent of metastatic disease (liver-limited disease versus non liver-limited disease) and tumor location (right versus left) after correction post-randomization.||2.71|0.96|0.132
73877455|NCT02365649|147294868|SUPERIORITY||Risk Difference (RD)|-50.0||||1|TWO_SIDED|95.0|-99.0|-1.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||-1.0|-99.0|1.000
74008714|NCT00718549|147567467|SUPERIORITY||Odds Ratio (OR)|1.923||||0.591|TWO_SIDED|95.0|0.225|41.751|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||41.751|0.225|0.591
74090761|NCT01765582|147735565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.005|TWO_SIDED|90.0|0.53|0.88|||Log Rank|||Stratified by extent of metastatic disease (liver-limited disease vs. non-liver-limited disease) and tumor location (right vs. left) after correction post-randomization.||0.88|0.53|0.005
74090762|NCT00986180|147735571|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was recalculated due to Amendment INT-1. The non-inferiority margin for SPID120 was set as 120. The common standard deviation for the SPID120 data was estimated to be 230. Seventy nine subjects in each arm would have 90% power to demonstrate the non-inferiority of NUCYNTA to oxycodone IR with a 1-sided significance level of 0.025. This would have required enrollment of total 158 mITT subjects for each stratum. The original sample size (292 mITT subjects) was derived for SPID72.|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|16.02||0.9703|TWO_SIDED|95.0|-32.1|30.9|||ANCOVA|||||30.9|-32.1|0.9703
74090763|NCT00986180|147735572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|6.08||0.7691|TWO_SIDED|95.0|-10.1|13.7|||ANCOVA|||||13.7|-10.1|0.7691
74090764|NCT00986180|147735573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|9.24||0.9282|TWO_SIDED|95.0|-17.3|19.0|||ANCOVA|||||19.0|-17.3|0.9282
74090765|NCT00986180|147735574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|29.75||0.9562|TWO_SIDED|95.0|-60.1|56.8|||ANCOVA|||||56.8|-60.1|0.9562
74090766|NCT00986180|147735575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|6.08||0.7973|TWO_SIDED|95.0|-13.5|10.4|||ANCOVA|||||10.4|-13.5|0.7973
74090767|NCT00986180|147735576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|9.3||0.7882|TWO_SIDED|95.0|-20.8|15.8|||ANCOVA|||||15.8|-20.8|0.7882
74090768|NCT00986180|147735577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|15.82||0.7491|TWO_SIDED|95.0|-36.1|26.0|||ANCOVA|||||26.0|-36.1|0.7491
73877456|NCT02365649|147294868|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
74090769|NCT00986180|147735578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|29.03||0.6897|TWO_SIDED|95.0|-68.6|45.4|||ANCOVA|||||45.4|-68.6|0.6897
74008715|NCT00718549|147567467|SUPERIORITY||Odds Ratio (OR)|1.3||||0.796|TWO_SIDED|95.0|0.147|9.222|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||9.222|0.147|0.796
74008716|NCT00718549|147567467|SUPERIORITY||Odds Ratio (OR)|3.2||||0.338|TWO_SIDED|95.0|0.375|69.479|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||69.479|0.375|0.338
74090770|NCT00986180|147735579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|7.02||0.8226|TWO_SIDED|95.0|-12.2|15.4|||ANCOVA|||||15.4|-12.2|0.8226
74090771|NCT00986180|147735580|SUPERIORITY_OR_OTHER|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.8880
74090772|NCT00986180|147735581|SUPERIORITY_OR_OTHER|||||||0.4115|||||||Wilcoxon (Mann-Whitney)|||||||0.4115
74090773|NCT00986180|147735582|SUPERIORITY_OR_OTHER|||||||0.8495|||||||Wilcoxon (Mann-Whitney)|||||||0.8495
74090774|NCT00986180|147735583|SUPERIORITY_OR_OTHER|||||||0.7846|||||||Wilcoxon (Mann-Whitney)|||||||0.7846
74090775|NCT00986180|147735584|SUPERIORITY_OR_OTHER|||||||0.479|||||||Wilcoxon (Mann-Whitney)|||||||0.4790
74090776|NCT00986180|147735585|SUPERIORITY_OR_OTHER|||||||0.3147|||||||Wilcoxon (Mann-Whitney)|||||||0.3147
74090777|NCT00986180|147735586|SUPERIORITY_OR_OTHER|||||||0.5411|||||||Wilcoxon (Mann-Whitney)|||||||0.5411
74090778|NCT00986180|147735587|SUPERIORITY_OR_OTHER|||||||0.6137|||||||Wilcoxon (Mann-Whitney)|||||||0.6137
74090779|NCT00986180|147735588|SUPERIORITY_OR_OTHER|||||||0.7246|||||||Wilcoxon (Mann-Whitney)|||||||0.7246
74090780|NCT00986180|147735589|SUPERIORITY_OR_OTHER|||||||0.4882|||||||Wilcoxon (Mann-Whitney)|||||||0.4882
74090781|NCT00986180|147735590|SUPERIORITY_OR_OTHER|||||||0.7201|||||||Cochran-Mantel-Haenszel|||||||0.7201
74090782|NCT00986180|147735592|SUPERIORITY_OR_OTHER|||||||0.5208|||||||Cochran-Mantel-Haenszel|||||||0.5208
74090783|NCT00986180|147735594|SUPERIORITY_OR_OTHER|||||||0.0401|||||||Cochran-Mantel-Haenszel|||||||0.0401
74090784|NCT00986180|147735596|SUPERIORITY_OR_OTHER|||||||0.4679|||||||Cochran-Mantel-Haenszel|||||||0.4679
74090785|NCT00986180|147735598|SUPERIORITY_OR_OTHER|||||||0.1454|||||||Fisher Exact|||||||0.1454
74090786|NCT00986180|147735599|SUPERIORITY_OR_OTHER|||||||0.1541|||||||Fisher Exact|||||||0.1541
73877457|NCT02365649|147294868|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
73877458|NCT02365649|147294868|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
73877459|NCT02365649|147294869|SUPERIORITY||Risk Difference (RD)|-66.7||||1|TWO_SIDED|95.0|-100.0|-13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||-13.3|-100.0|1.000
73877460|NCT02365649|147294869|SUPERIORITY||Risk Difference (RD)|33.3||||0.25|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||86.7|-20.0|0.250
73877461|NCT02365649|147294869|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||95.6|-62.2|1.000
73877462|NCT02365649|147294869|SUPERIORITY||Risk Difference (RD)|-33.3||||0.5|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||4.4|-71.1|0.500
74000744|NCT00910689|147550036|SUPERIORITY_OR_OTHER||||||<|0.03|TWO_SIDED|95.0||||6 pair wise contrasts were conducted: The first 3 contrasts compared each of the 3 additive treatments to OAT + PL. The 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (PROC MIXED, SAS 9).When the treatment by time interaction was significant (p \< .05, 2-tailed)post-tests were conducted (see below).Details of significant post tests are reported as separate analyses.||||< .03
74000745|NCT00910689|147550036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.03|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
74000746|NCT00910689|147550036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|1.12|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
73877463|NCT02365649|147294869|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||4.4|-71.1|1.000
74000747|NCT00910689|147550036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_DEVIATION|1.26|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
73877464|NCT02586623|147294882|SUPERIORITY||Cox Proportional Hazard|1.04||||0.803|TWO_SIDED|95.0|0.67|1.62|||Log Rank||Droxidopa / Placebo|||1.62|0.67|0.803
73877465|NCT00965250|147294931|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kaplan Meier|||||||<0.0001
74036842|NCT01617655|147627046|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.8||||0.0164|TWO_SIDED|95.0|-26.9|-2.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-2.7|-26.9|0.0164
73877466|NCT00965250|147294932|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kaplan Meier|||||||<0.0001
73877467|NCT00871871|147294967|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.067|TWO_SIDED|90.0|-0.22|0.01||one-sided, alpha = 0.05|ANCOVA|||||0.01|-0.22|0.067
73877468|NCT00871871|147294968|SUPERIORITY_OR_OTHER||Least squares mean difference|1.1|||>|0.5|TWO_SIDED|90.0|0.86|1.34|||ANCOVA|||||1.34|0.86|>0.500
73877469|NCT00871871|147294969|SUPERIORITY_OR_OTHER||Least squares mean difference|0.016||||0.13|TWO_SIDED|90.0|-0.012|0.044||one-sided, alpha = 0.05|ANOVA|||||0.044|-0.012|0.130
74036843|NCT01617655|147627047|SUPERIORITY_OR_OTHER||LS mean difference|3.7||||0.2745|TWO_SIDED|95.0|-2.9|10.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.2|-2.9|0.2745
74036844|NCT01175213|147627059|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.02|||<|0.0001|ONE_SIDED|99.0||0.045||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson|||||0.045||<0.0001
73877470|NCT00871871|147294970|SUPERIORITY_OR_OTHER||Least squares mean difference|0.54|||>|0.5|TWO_SIDED|90.0|0.4|0.67|||ANCOVA|||||0.67|0.40|>0.500
73877471|NCT00871871|147294971|SUPERIORITY_OR_OTHER||Least squares mean difference|0.004||||0.342|TWO_SIDED|90.0|-0.023|0.014||one-sided, alpha = 0.05|ANOVA|||||0.014|-0.023|0.342
74000748|NCT00910689|147550036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.2|>|0.02|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .02
74000749|NCT00910689|147550036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|1.35|>|0.79||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>.79
74000750|NCT00910689|147550036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.43|>|0.02||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|||Post-test contrast. Mean difference in change.||||>.02
74000751|NCT00910689|147550037|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED|95.0||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); three additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure controlled the familywise type I error for the 6 contrasts at .05. Adjusted p=.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction and pretreatment Migraine Specific Quality of Life scores as covariate was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (using the PROC MIXED procedure in SAS statistical software, version 9; www. sas.com).A significant treatment by time interaction (p \< .05, 2-tailed) was followed by post-tests||||<.005
74036845|NCT03224585|147627083|SUPERIORITY|||||||0.0121|||||||Paired samples Wilcoxon test|||This analysis compared the change in pain scores between baseline and 6 hours||||0.0121
74036846|NCT03224585|147627084|SUPERIORITY|||||||0.0025|||||||Paired samples Wilcoxon test|||||||0.0025
74036847|NCT01921634|147627085|SUPERIORITY||Odds Ratio (OR)|1.3||||0.01|TWO_SIDED|95.0|1.1|1.7|||McNemar||The odds ratio was generated from a logistic regression model using generalized estimating equations with a logit link and represents a comparison of modified (numerator) vs standard (denominator).|||1.7|1.1|0.01
74036848|NCT03057951|147627088|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.79||||0.0003|TWO_SIDED|95.03|0.69|0.9|||Regression, Cox||Comparison vs. Placebo \[T/P\]|"Cox regression, with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) at baseline.~alpha=0.0497 (resulting from interim analysis)."||0.90|0.69|0.0003
74036849|NCT03057951|147627089|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.73||||0.0009|TWO_SIDED|95.03|0.61|0.88|||Joint frailty model||Comparison vs. Placebo \[T/P\]|Joint frailty model that accounts for dependence between recurrent HHF and cardiovascular death, with terms for age, baseline eGFR (CKD-EPK)cr, baseline LVEF, region, baseline diabetes status, sex, and treatment. eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction. alpha=0.0497 (resulting from interim analysis).||0.88|0.61|0.0009
74036850|NCT03057951|147627090|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Treatment by time interaction|1.363|||<|0.0001|TWO_SIDED|99.9|0.861|1.865|||Random intercept random coeff. model||Empa 10 mg vs. Placebo slope \[/year\]|"Random coefficient model allowing for random intercept and random slope per patient, with factors age, baseline eGFR (CKD-EPI), baseline LVEF as linear covariate(s) and region, baseline diabetes status, sex, baseline-by-time interaction, treatment-by-time interaction and treatment as fixed effects.~Only 'on-treatment' data from treated patients were used. alpha=0.001. covariance structure: Unstructured."||1.865|0.861|<0.0001
74036851|NCT03057951|147627091|OTHER||Hazard Ratio (HR)|0.95||||0.7243|TWO_SIDED|95.0|0.73|1.24|||Regression, Cox||Comparison vs Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.24|0.73|0.7243
74036852|NCT03057951|147627092|OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.6|0.83|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||0.83|0.60|<0.0001
74036853|NCT03057951|147627093|OTHER||Hazard Ratio (HR)|0.91||||0.2951|TWO_SIDED|95.0|0.76|1.09|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.09|0.76|0.2951
74000752|NCT00910689|147550037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.18|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||< .001
74000753|NCT00910689|147550037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0|STANDARD_DEVIATION|2.41|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
74000754|NCT00910689|147550037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|STANDARD_DEVIATION|1.67|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||< .001
74000755|NCT00910689|147550037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.9|STANDARD_DEVIATION|2.03|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
74000756|NCT00910689|147550037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|1.83|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
74000757|NCT00910689|147550037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|2.38|>|0.87||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.87
74000758|NCT00910689|147550038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.77|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||<.001
73877472|NCT00871871|147294972|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0016|||>|0.5|TWO_SIDED|90.0|-0.008|0.011|||ANOVA|||||0.011|-0.008|>0.500
73877473|NCT00871871|147294973|SUPERIORITY_OR_OTHER||Least squares mean difference|0.003|||>|0.5|TWO_SIDED|90.0|-0.003|0.01|||ANOVA|||||0.010|-0.003|>0.500
73877474|NCT00479713|147294978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|1.72|<=|0.001||95.0|-14.1|-7.33|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-7.33|-14.10|<=0.001
74000759|NCT00910689|147550038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.79|>|0.83|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .83
74000760|NCT00910689|147550038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.67|>|0.05|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||> .05
74000761|NCT00910689|147550038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.86|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Significant post-test contrast. Mean difference in change.||||< .001
74000762|NCT00910689|147550038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.95|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
74000763|NCT00910689|147550038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.89|>|0.2|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .20
74000764|NCT00910689|147550039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_DEVIATION|1.7|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||<.001
74000765|NCT00910689|147550039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6|STANDARD_DEVIATION|1.96|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
73877475|NCT00479713|147294979|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1|||<=|0.001||95.0|1.5|3.0|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of \< 100 mg/dL (2.59 mmol/L)||3.0|1.5|<=0.001
74000766|NCT00910689|147550039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.69|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
74036854|NCT03057951|147627094|OTHER||Hazard Ratio (HR)|1.0||||0.9893|TWO_SIDED|95.0|0.87|1.15|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.15|0.87|0.9893
74000767|NCT00910689|147550039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.69|>|0.04||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.04
74000768|NCT00910689|147550039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.34|>|0.33||95.0||||Bonerfoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>0.33
74000769|NCT00910689|147550039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.68|>|0.21||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.21
74000770|NCT00910689|147550040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.4|STANDARD_DEVIATION|3.0|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
74000771|NCT00910689|147550040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|3.29|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
74000772|NCT00910689|147550040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|STANDARD_DEVIATION|2.99|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
74090787|NCT00986180|147735601|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.92|2.06|||Cochran-Mantel-Haenszel|||||2.06|0.92|
74090788|NCT00986180|147735602|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||||TWO_SIDED|95.0|1.17|2.57|||Cochran-Mantel-Haenszel|||||2.57|1.17|
74090789|NCT00986180|147735603|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.43|||||TWO_SIDED|95.0|1.45|8.11|||Cochran-Mantel-Haenszel|||||8.11|1.45|
73877476|NCT00479713|147294979|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8|||<=|0.001||95.0|1.8|4.4|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of \< 70 mg/dL (1.81 mmol/L)||4.4|1.8|<=0.001
73877477|NCT00479713|147294980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|1.2|<=|0.001||95.0|-9.56|-4.84|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-4.84|-9.56|<=0.001
73877478|NCT00479713|147294981|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.06||||0.056||95.0|-9.56|-0.3|||Nonparametric ANOVA|ANOVA model based on Tukey's normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval (CI) based on Wilcoxon's rank.|||-0.30|-9.56|0.056
73877479|NCT00479713|147294982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|1.17||0.433||95.0|-3.21|1.38|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||1.38|-3.21|0.433
74090790|NCT00986180|147735604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.54|1.67|||Cochran-Mantel-Haenszel|||||1.67|0.54|
74090791|NCT00986180|147735605|SUPERIORITY_OR_OTHER|||||||0.5828|||||||Log Rank|||||||0.5828
74090792|NCT00986180|147735606|SUPERIORITY_OR_OTHER|||||||0.9084|||||||Log Rank|||||||0.9084
74000773|NCT00910689|147550040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_DEVIATION|2.85|>|0.56||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.56
74000774|NCT00910689|147550040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|2.45|>|0.08||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>0.08
74000775|NCT00910689|147550040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|2.83|>|0.03||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.03
74000776|NCT01248780|147550108|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74000777|NCT01248780|147550109|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74000778|NCT01248780|147550110|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74000779|NCT01248780|147550111|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
74000780|NCT00955253|147550138|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||between the placebo and guanfacine conditions||||0.013
74000781|NCT04101318|147550140|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.625|TWO_SIDED|95.0|-0.38|0.62||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.62|-0.38|0.625
74000782|NCT04101318|147550141|SUPERIORITY||Odds Ratio (OR)|1.737||||0.036|TWO_SIDED|95.0|1.038|2.908||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for itching evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.908|1.038|0.036
74000783|NCT04101318|147550142|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.202|TWO_SIDED|95.0|-0.9|0.2||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|The mode had following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.20|-0.90|0.202
74000784|NCT04101318|147550143|SUPERIORITY||Odds Ratio (OR)|1.369||||0.267|TWO_SIDED|95.0|0.781|2.401||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for pain evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.401|0.781|0.267
74000785|NCT04101318|147550144|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.545|TWO_SIDED|95.0|-0.57|0.3||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.30|-0.57|0.545
74000786|NCT04101318|147550145|SUPERIORITY||Odds Ratio (OR)|1.316||||0.293|TWO_SIDED|95.0|0.783|2.211||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for burning evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.211|0.783|0.293
74000787|NCT04101318|147550146|SUPERIORITY||Odds Ratio (OR)|0.82||||0.375|TWO_SIDED|95.0|0.53|1.27||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects|Odds ratio, marginal= Arm1/Arm2|There is no difference between the two arms.||1.27|0.53|0.375
74090793|NCT03261960|147735637|NON_INFERIORITY|Non-inferiority margin was set at 10%.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74000788|NCT04101318|147550147|SUPERIORITY||Odds Ratio (OR)|0.83||||0.482|TWO_SIDED|95.0|0.49|1.4||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||1.40|0.49|0.482
74000789|NCT04101318|147550148|SUPERIORITY||Odds Ratio (OR)|0.7||||0.151|TWO_SIDED|95.0|0.43|1.14||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects||Null hypothesis: There is no difference between the two arms.|Odds ratio, marginal= Arm1/Arm2|1.14|0.43|0.151
74000790|NCT04101318|147550149|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.725|TWO_SIDED|95.0|-0.39|0.56||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.56|-0.39|0.725
74000791|NCT04101318|147550150|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.721|TWO_SIDED|95.0|-0.39|0.56||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.56|-0.39|0.721
74008717|NCT00718549|147567467|SUPERIORITY||Odds Ratio (OR)|2.333||||0.486|TWO_SIDED|95.0|0.201|29.008|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||29.008|0.201|0.486
74000792|NCT04101318|147550151|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.753|TWO_SIDED|95.0|-0.38|0.28||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.28|-0.38|0.753
74000793|NCT04101318|147550152|SUPERIORITY||Mean Difference (Final Values)|1.37||||0.331|TWO_SIDED|95.0|-1.43|4.18||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||4.18|-1.43|0.331
74000794|NCT04101318|147550153|SUPERIORITY||Mean Difference (Final Values)|11.68||||0.239|TWO_SIDED|95.0|-7.98|31.34||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||31.34|-7.98|0.239
74000795|NCT04101318|147550154|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.322|TWO_SIDED|95.0|-0.91|0.31||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.31|-0.91|0.322
74000796|NCT04101318|147550155|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.343|TWO_SIDED|95.0|-0.44|0.15||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.15|-0.44|0.343
74000797|NCT04101318|147550156|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.387|TWO_SIDED|95.0|-0.53|0.21||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.21|-0.53|0.387
74000798|NCT04101318|147550157|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.899|TWO_SIDED|95.0|-0.18|0.16||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.16|-0.18|0.899
74000799|NCT00558259|147550158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.08|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.02|0.25|||Regression, Cox|||Dabigatran vs placebo||0.25|0.02|<0.0001
74000800|NCT00558259|147550159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.08|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.03|0.27|||Regression, Cox|||Dabigatran vs placebo||0.27|0.03|<0.0001
73877480|NCT00479713|147294983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.41|STANDARD_ERROR_OF_MEAN|1.58|<=|0.001||95.0|-12.5|-6.31|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-6.31|-12.50|<=0.001
74000801|NCT00558259|147550160|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||< 0.0001
74000802|NCT00558259|147550160|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.06|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in Dabigatran group.|||1.06|0.04|
74000803|NCT00558259|147550160|SUPERIORITY_OR_OTHER||Percentage of participants with events|3.5|||||TWO_SIDED|95.0|2.21|5.17|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in placebo group.|||5.17|2.21|
74036855|NCT03057951|147627095|OTHER||Hazard Ratio (HR)|0.84||||0.1539|TWO_SIDED|95.0|0.65|1.07|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.07|0.65|0.1539
74036856|NCT03057951|147627096|OTHER||Adjusted mean difference|1.32|STANDARD_ERROR_OF_MEAN|0.44||0.0028|TWO_SIDED|95.0|0.45|2.19|||Mixed Model Repeated Measures (MMRM)||Comparison vs Placebo \[T-P\]|"Model includes age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF) as linear covariate(s) and region, baseline diabetes status, sex, week reachable, treatment-by-visit interaction, baseline KCCQ-Clinical-Summary-Score-by-visit interaction as fixed effect(s).~Unstructured covariance structure."||2.19|0.45|0.0028
74000804|NCT00558259|147550161|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Fisher Exact|||Dabigatran vs. Placebo||||0.0004
74000805|NCT00558259|147550161|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.1|||||TWO_SIDED|95.0|0.0|0.82|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in Dabigatran group.|||0.82|0.00|
74000806|NCT00558259|147550161|SUPERIORITY_OR_OTHER||Percentage of participants with events|2.1|||||TWO_SIDED|95.0|1.16|3.52|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in placebo group.|||3.52|1.16|
74000807|NCT00558259|147550162|SUPERIORITY_OR_OTHER|||||||0.2428|||||||Fisher Exact|||Dabigatran vs. Placebo||||0.2428
73877481|NCT00479713|147294984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.59|STANDARD_ERROR_OF_MEAN|1.98|<=|0.001||95.0|-13.49|-5.69|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-5.69|-13.49|<=0.001
73877482|NCT00479713|147294985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.25|STANDARD_ERROR_OF_MEAN|1.44|<=|0.001||95.0|-9.07|-3.43|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-3.43|-9.07|<=0.001
73877483|NCT00479713|147294986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.11|STANDARD_ERROR_OF_MEAN|1.43|<=|0.001||95.0|-10.91|-5.3|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-5.30|-10.91|<=0.001
74000808|NCT00558259|147550162|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.0|||||TWO_SIDED|95.0|0.0|0.54|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in Dabigatran group.|||0.54|0.00|
74000809|NCT00558259|147550162|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.09|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in placebo group.|||1.09|0.04|
74000810|NCT00558259|147550163|SUPERIORITY_OR_OTHER|||||||0.4998||||||As the Cox model did not converge due to too few events, hazard ratios are not estimable.|Fisher Exact|||Dabigatran vs. Placebo - Analysis of time to first occurrence of an MBE during the treatment period - FAS - as treated.||||0.4998
74000811|NCT00558259|147550163|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.05|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in Dabigatran group.|||1.05|0.04|
73877484|NCT00479713|147294987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.67||||0.172||95.0|-16.67|2.87|||Nonparametric ANOVA|ANOVA model based on Tukey's normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free CI based on Wilcoxon's rank|||2.87|-16.67|0.172
73877485|NCT03863509|147294990|OTHER|||||||0.494|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 384) = 0.707, p = .494||||||.494
73877486|NCT03863509|147294991|OTHER|||||||0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference F(2, 381) = 7.409, p = .001||||||0.001
74000812|NCT00558259|147550163|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.0|||||TWO_SIDED|95.0|0.0|0.56|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in placebo group.|||0.56|0.00|
74000813|NCT00558259|147550163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.92|STANDARD_ERROR_OF_MEAN|0.97||0.0013|TWO_SIDED|95.0|1.52|5.6|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of a MBE or CRBE during the treatment period - FAS - as treated.||5.60|1.52|0.0013
74000814|NCT00558259|147550163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.82|STANDARD_ERROR_OF_MEAN|0.36||0.0027|TWO_SIDED|95.0|1.23|2.68|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of any bleeding event during the treatment period - FAS - as treated||2.68|1.23|0.0027
74000815|NCT00370331|147550184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.2|||<|0.001||99.0|3.59|18.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized Estimating Equations (GEE)||||18.73|3.59|<0.001
74000816|NCT01874431|147550194|OTHER||Least square mean ratio|0.926||||0.1973|TWO_SIDED|90.0|0.799|1.074|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an analysis of covariance (ANCOVA) with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a last-observation carried-forward (LOCF) method for missing observations.||1.074|0.799|0.1973
74000817|NCT01874431|147550194|OTHER||Least square mean ratio|0.949||||0.2808|TWO_SIDED|90.0|0.818|1.101|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||1.101|0.818|0.2808
73877487|NCT03863509|147294991|OTHER||Mean Difference (Final Values)|-0.42||||0.822|TWO_SIDED|95.0|-4.08|3.24|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race/ethnicity were covaried.||these are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||3.240|-4.080|0.822
74000818|NCT01874431|147550194|OTHER||Least square mean ratio|0.878||||0.0723|TWO_SIDED|90.0|0.758|1.017|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||1.017|0.758|0.0723
74000819|NCT01874431|147550194|OTHER||Least square mean ratio|0.787||||0.0039|TWO_SIDED|90.0|0.68|0.912|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.912|0.68|0.0039
74000820|NCT01874431|147550194|OTHER||Least square mean ratio|0.755||||0.0009|TWO_SIDED|90.0|0.651|0.875|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.875|0.651|0.0009
74008718|NCT00718549|147567467|SUPERIORITY||Odds Ratio (OR)|0.667||||0.691|TWO_SIDED|95.0|0.074|4.722|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||4.722|0.074|0.691
74008719|NCT00718549|147567467|SUPERIORITY||Odds Ratio (OR)|1.5||||0.691|TWO_SIDED|95.0|0.212|13.563|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||13.563|0.212|0.691
74008720|NCT00718549|147567467|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.076|24.621|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||24.621|0.076|1.000
74008721|NCT00718549|147567467|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.099|22.791|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||22.791|0.099|1.000
74008722|NCT02606461|147567487|SUPERIORITY||Hazard Ratio (HR)|0.7026||||0.0114|TWO_SIDED|95.0|0.5191|0.9509|||Log Rank|||||0.9509|0.5191|0.0114
74008723|NCT02606461|147567489|SUPERIORITY||Hazard Ratio, log|1.1521||||0.6051|TWO_SIDED|95.0|0.5357|2.4778|||Log Rank|||||2.4778|0.5357|0.6051
74000821|NCT01874431|147550194|OTHER||Least square mean ratio|0.671|||<|0.0001|TWO_SIDED|90.0|0.584|0.772|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.772|0.584|< 0.0001
74000822|NCT01874431|147550194|OTHER||Least square mean ratio|0.624|||<|0.0001|TWO_SIDED|90.0|0.542|0.718|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.718|0.542|< 0.0001
74000823|NCT01874431|147550195|OTHER||Least squares mean difference|0.107||||0.0428|TWO_SIDED|95.0|0.003|0.21|||t-test, 2 sided|||||0.21|0.003|0.0428
74000824|NCT01874431|147550195|OTHER||Least squares mean difference|0.121||||0.0223|TWO_SIDED|95.0|0.017|0.225|||t-test, 2 sided|||||0.225|0.017|0.0223
74000825|NCT01874431|147550195|OTHER||Least squares mean difference|0.2||||0.0002|TWO_SIDED|95.0|0.096|0.305|||t-test, 2 sided|||||0.305|0.096|0.0002
74000826|NCT01874431|147550195|OTHER||Least squares mean difference|0.125||||0.0181|TWO_SIDED|95.0|0.021|0.229|||t-test, 2 sided|||||0.229|0.021|0.0181
74000827|NCT01874431|147550195|OTHER||Least squares mean difference|0.166||||0.0019|TWO_SIDED|95.0|0.061|0.27|||t-test, 2 sided|||||0.27|0.061|0.0019
74000828|NCT01874431|147550195|OTHER||Least squares mean difference|0.236|||<|0.0001|TWO_SIDED|95.0|0.137|0.334|||t-test, 2 sided|||||0.334|0.137|< 0.0001
74000829|NCT01874431|147550195|OTHER||Least squares mean difference|0.186||||0.0002|TWO_SIDED|95.0|0.088|0.284|||t-test, 2 sided|||||0.284|0.088|0.0002
73877488|NCT03863509|147294991|OTHER||Mean Difference (Final Values)|7.267||||0.001|TWO_SIDED|95.0|2.974|11.559|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||these are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||11.559|2.974|0.001
74000830|NCT01874431|147550196|OTHER||Least squares mean difference|-0.786||||0.5454|TWO_SIDED|95.0|-3.337|1.765|||t-test, 2 sided|||||1.765|-3.337|0.5454
74000831|NCT01874431|147550196|OTHER||Least squares mean difference|-1.61||||0.2186|TWO_SIDED|95.0|-4.177|0.957|||t-test, 2 sided|||||0.957|-4.177|0.2186
74000832|NCT01874431|147550196|OTHER||Least squares mean difference|-0.918||||0.4859|TWO_SIDED|95.0|-3.503|1.667|||t-test, 2 sided|||||1.667|-3.503|0.4859
74000833|NCT01874431|147550196|OTHER||Least squares mean difference|-1.8||||0.1677|TWO_SIDED|95.0|-4.358|0.759|||t-test, 2 sided|||||0.759|-4.358|0.1677
74000834|NCT01874431|147550196|OTHER||Least squares mean difference|-2.613||||0.0462|TWO_SIDED|95.0|-5.183|-0.044|||t-test, 2 sided|||||-0.044|-5.183|0.0462
74000835|NCT01874431|147550196|OTHER||Least squares mean difference|-2.228||||0.0705|TWO_SIDED|95.0|-4.643|0.187|||t-test, 2 sided|||||0.187|-4.643|0.0705
74000836|NCT01874431|147550196|OTHER||Least squares mean difference|-2.446||||0.048|TWO_SIDED|95.0|-4.869|-0.022|||t-test, 2 sided|||||-0.022|-4.869|0.048
74000837|NCT01874431|147550197|OTHER||Least square mean difference|-2.863||||0.0757|TWO_SIDED|95.0|-6.022|0.297|||t-test, 2 sided|||||0.297|-6.022|0.0757
74000838|NCT01874431|147550197|OTHER||Least square mean difference|-0.643||||0.6941|TWO_SIDED|95.0|-3.851|2.565|||t-test, 2 sided|||||2.565|-3.851|0.6941
74000839|NCT01874431|147550197|OTHER||Least square mean difference|-1.976||||0.2228|TWO_SIDED|95.0|-5.155|1.203|||t-test, 2 sided|||||1.203|-5.155|0.2228
74000840|NCT01874431|147550197|OTHER||Least square mean difference|-1.932||||0.2313|TWO_SIDED|95.0|-5.098|1.234|||t-test, 2 sided|||||1.234|-5.098|0.2313
74000841|NCT01874431|147550197|OTHER||Least square mean difference|-3.342||||0.0386|TWO_SIDED|95.0|-6.509|-0.176|||t-test, 2 sided|||||-0.176|-6.509|0.0386
74000842|NCT01874431|147550197|OTHER||Least square mean difference|-0.634||||0.677|TWO_SIDED|95.0|-3.624|2.355|||t-test, 2 sided|||||2.355|-3.624|0.677
74000843|NCT01874431|147550197|OTHER||Least square mean difference|-0.688||||0.6536|TWO_SIDED|95.0|-3.699|2.322|||t-test, 2 sided|||||2.322|-3.699|0.6536
74000844|NCT01874431|147550198|OTHER||Least square mean difference|-3.044||||0.0816|TWO_SIDED|95.0|-6.471|0.383|||t-test, 2 sided|||||0.383|-6.471|0.0816
74000845|NCT01874431|147550198|OTHER||Least square mean difference|-0.537||||0.7625|TWO_SIDED|95.0|-4.027|2.953|||t-test, 2 sided|||||2.953|-4.027|0.7625
74000846|NCT01874431|147550198|OTHER||Least square mean difference|-1.301|||=|0.4603|TWO_SIDED|95.0|-4.759|2.157|||t-test, 2 sided|||||2.157|-4.759|= 0.4603
74000847|NCT01874431|147550198|OTHER||Least square mean difference|-1.574||||0.3678|TWO_SIDED|95.0|-5.004|1.855|||t-test, 2 sided|||||1.855|-5.004|0.3678
74000848|NCT01874431|147550198|OTHER||Least square mean difference|-1.727||||0.3279|TWO_SIDED|95.0|-5.191|1.736|||t-test, 2 sided|||||1.736|-5.191|0.3279
74000849|NCT01874431|147550198|OTHER||Least square mean difference|-1.682||||0.3102|TWO_SIDED|95.0|-4.935|1.57|||t-test, 2 sided|||||1.57|-4.935|0.3102
74000850|NCT01874431|147550198|OTHER||Least square mean difference|-2.511||||0.1317|TWO_SIDED|95.0|-5.778|0.755|||t-test, 2 sided|||||0.755|-5.778|0.1317
74000851|NCT01981473|147550199|SUPERIORITY_OR_OTHER||||||<|0.0001||||||As there was only one primary endpoint, no adjustment was made for multiple comparisons.|Fisher Exact|Logistic regression was to be used but the model was not fit as there were no antibodies in the etanercept group. Fisher's exact test was used.||This sample was to provide \>95% power to detect a difference of 12% in the proportion of participants positive for antidrug antibodies between the group of participants treated with a soluble receptor TNF inhibitor (etanercept) and the group of participants treated with mAB TNF inhibitors (adalimumab and infliximab) (5% vs 17%, respectively), using a Chi square test with continuity correction, an alpha of 0.05, and attrition rate of 15%.||||<0.0001
74000852|NCT00545051|147550218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.25|||<|0.001|TWO_SIDED|95.0|2.09|4.41|||ANCOVA|||||4.41|2.09|<0.001
74000853|NCT00545051|147550219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.22|3.23|||ANCOVA|||||3.23|1.22|<0.001
74000854|NCT00545051|147550220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.122|TWO_SIDED|95.0|-0.15|1.25|||ANCOVA|||Month 6||1.25|-0.15|0.122
74000855|NCT00545051|147550220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|||<|0.001|TWO_SIDED|95.0|0.96|2.66|||ANCOVA|||Month 12||2.66|0.96|<0.001
74000856|NCT00545051|147550221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 1||||<0.001
74000857|NCT00545051|147550221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 6||||<0.001
74000858|NCT00545051|147550221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 12||||<0.001
74000859|NCT00545051|147550221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 1||||<0.001
74000860|NCT00545051|147550221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 6||||<0.001
74000861|NCT00545051|147550221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 12||||<0.001
74000862|NCT00545051|147550221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 1||||<0.001
74000863|NCT00545051|147550221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 6||||<0.001
73877489|NCT03863509|147294991|OTHER||Mean Difference (Final Values)|7.687|||<|0.001|TWO_SIDED|95.0|3.485|11.889|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||These are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||11.889|3.485|<0.001
73877490|NCT03863509|147294992|OTHER|||||||0.074||||||Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 2.616, p = .074|ANCOVA|||||||.074
74000864|NCT00545051|147550221|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 12||||<0.001
74000865|NCT02257567|147550258|SUPERIORITY||Difference in Response Rates|5.82||||0.5353|TWO_SIDED|95.0|-14.53|25.38|||Cochran-Mantel-Haenszel|||||25.38|-14.53|0.5353
74000866|NCT02257567|147550258|SUPERIORITY||Difference in Response Rates (4.89|25.0||||0.0128|TWO_SIDED|95.0|4.89|42.63|||Cochran-Mantel-Haenszel|||||42.63|4.89|0.0128
74000867|NCT02257567|147550267|SUPERIORITY||Difference in Response Rates|0.69||||0.8817|TWO_SIDED|95.0|-19.68|20.86|||Cochran-Mantel-Haenszel|||||20.86|-19.68|0.8817
74000868|NCT02257567|147550267|SUPERIORITY||Difference in Response Rates|27.5||||0.0061|TWO_SIDED|95.0|7.66|44.74|||Cochran-Mantel-Haenszel|||||44.74|7.66|0.0061
74000869|NCT02257567|147550269|SUPERIORITY||Difference in Response Rates|-1.0||||0.9523|TWO_SIDED|95.0|-18.66|16.46|||Cochran-Mantel-Haenszel|||||16.46|-18.66|0.9523
74000870|NCT02257567|147550269|SUPERIORITY||Difference in Response Rates|30.0||||0.0036|TWO_SIDED|95.0|9.48|47.37|||Cochran-Mantel-Haenszel|||||47.37|9.48|0.0036
74000871|NCT02257567|147550270|SUPERIORITY||Difference in Response Rates|3.75||||0.6574|TWO_SIDED|95.0|-15.14|22.11|||Cochran-Mantel-Haenszel|||||22.11|-15.14|0.6574
74000872|NCT02257567|147550270|SUPERIORITY||Difference in Response Rates|25.0||||0.0128|TWO_SIDED|95.0|4.89|42.63|||Cochran-Mantel-Haenszel|||||42.63|4.89|0.0128
74000873|NCT02257567|147550273|SUPERIORITY||Difference in Response Rates|3.88||||0.6225|TWO_SIDED|95.0|-14.49|21.72|||Cochran-Mantel-Haenszel|||||21.72|-14.49|0.6225
74000874|NCT02257567|147550273|SUPERIORITY||Difference in Response Rates|30.0||||0.0032|TWO_SIDED|95.0|9.94|47.12|||Cochran-Mantel-Haenszel|||||47.12|9.94|0.0032
74000875|NCT02257567|147550274|SUPERIORITY||Difference in Response Rates|-6.13||||0.4835|TWO_SIDED|95.0|-24.14|12.12|||Cochran-Mantel-Haenszel|||||12.12|-24.14|0.4835
74000876|NCT02257567|147550274|SUPERIORITY||Difference in Response Rates|25.0||||0.0096|TWO_SIDED|95.0|5.39|42.33|||Cochran-Mantel-Haenszel|||||42.33|5.39|0.0096
74000877|NCT02257567|147550275|SUPERIORITY||Difference in Response Rates|-0.5||||0.939|TWO_SIDED|95.0|-15.07|13.71|||Cochran-Mantel-Haenszel|||||13.71|-15.07|0.9390
74000878|NCT02257567|147550275|SUPERIORITY||Difference in Response Rates|37.5||||0.0006|TWO_SIDED|95.0|15.64|54.71|||Cochran-Mantel-Haenszel|||||54.71|15.64|0.0006
74000879|NCT02257567|147550276|SUPERIORITY||Difference in Response Rates|37.5||||0.0005|TWO_SIDED|95.0|15.82|54.62|||Cochran-Mantel-Haenszel|||||54.62|15.82|0.0005
74000880|NCT02257567|147550277|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0245|TWO_SIDED|95.0|0.19|0.91|||Log Rank|||||0.91|0.19|0.0245
74000881|NCT02257567|147550278|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.2451|TWO_SIDED|95.0|0.25|1.43|||Log Rank|||||1.43|0.25|0.2451
74000882|NCT02257567|147550279|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.2|0.56|||Log Rank|||||0.56|0.20|<.0001
74000883|NCT02257567|147550280|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.0003|TWO_SIDED|95.0|0.23|0.66|||Log Rank|||||0.66|0.23|0.0003
74000884|NCT01288521|147550376|SUPERIORITY|The null hypothesis is that the tacrolimus biovailability alone is equal to the tacrolimus bioavailability when given with ketoconazole.||||||0.006|||||||Regression, Linear|The bioavailability with Tac alone vs. Tac +keto was compared using linear model adjusting for sex and creatinine clearance.||The bioavailability of Tac alone vs. Tac +keto was compared using a general linear model including sex and creatinine clearance as covariates.||||0.006
74000885|NCT02084056|147550389|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.68|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|100.703|106.747|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||106.747|100.703|<0.0001
74008724|NCT03496324|147567513|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% confidence interval (CI) (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|94.19|STANDARD_ERROR_OF_MEAN|18.9|||TWO_SIDED|90.0|85.81|103.38||||||||103.38|85.81|
74008725|NCT03496324|147567513|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|111.66|STANDARD_ERROR_OF_MEAN|14.3|||TWO_SIDED|90.0|103.84|120.07||||||||120.07|103.84|
74008726|NCT03496324|147567514|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|101.57|STANDARD_ERROR_OF_MEAN|10.5|||TWO_SIDED|90.0|96.28|107.16||||||||107.16|96.28|
74008727|NCT03496324|147567514|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|104.47|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|90.0|101.4|107.63||||||||107.63|101.4|
73877491|NCT03863509|147294993|OTHER||Type III F-test of Fixed Group x Time ef|6.609||||0.002|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Omnibus Group x Time (pre-post) interaction test: F (2, 378.467) = 6.609, p = .002. Age, race, and sex were covaried.|F (2, 378.467) = 6.609, p = .002|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||.002
74036857|NCT03057951|147627097|OTHER||Hazard Ratio (HR)|0.93||||0.1012|TWO_SIDED|95.0|0.85|1.01|||Joint frailty model||Comparison vs. Placebo \[T/P\]|Joint frailty model that accounts for the dependence between recurrent all-cause hospitalisation and all-cause mortality was used. Joint frailty model with terms for age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF), treatment, region, baseline diabetes status and sex.||1.01|0.85|0.1012
73877492|NCT03863509|147294993|OTHER||interaction estimate|3.3|STANDARD_ERROR_OF_MEAN|0.99||0.001|TWO_SIDED|95.0|1.36|5.24|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in systolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||5.24|1.36|0.001
73877493|NCT03863509|147294993|OTHER||interaction term estimate|3.29|STANDARD_ERROR_OF_MEAN|1.06||0.002|TWO_SIDED|95.0|1.2|5.38|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in systolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive cigarette smokers x Time vs never users x time as reference|||5.38|1.20|0.002
73877494|NCT03863509|147294993|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.948||0.992|TWO_SIDED||||||ANCOVA|||||||.992
74000886|NCT02084056|147550389|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.63|STANDARD_ERROR_OF_MEAN|1.047||0.0003|TWO_SIDED|90.0|93.721|110.202|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||110.202|93.721|0.0003
74000887|NCT02084056|147550390|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|114.58|STANDARD_ERROR_OF_MEAN|1.038||0.0113|TWO_SIDED|90.0|107.687|121.908|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||121.908|107.687|0.0113
74000888|NCT02084056|147550390|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.28|STANDARD_ERROR_OF_MEAN|1.075||0.0064|TWO_SIDED|90.0|86.543|111.609|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||111.609|86.543|0.0064
74036858|NCT00696436|147627098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.27|||<|0.001|TWO_SIDED|95.0|-16.54|-12.01||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-12.01|-16.54|<0.001
74036859|NCT00696436|147627098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.16|||<|0.001|TWO_SIDED|95.0|-15.41|-10.91||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-10.91|-15.41|<0.001
73877495|NCT03863509|147294994|OTHER||Type III F-test of Fixed Group x Time ef|5.843||||0.003|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 378.999) = 5.843, p = .003|F (2, 378.999) = 5.843, p = .003|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.003
73877496|NCT03863509|147294994|OTHER||Interaction term Coefficient|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.002|TWO_SIDED|95.0|0.01|0.05|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||0.05|0.01|.002
73877497|NCT03863509|147294994|OTHER||Interaction term Coefficient|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.003|TWO_SIDED|95.0|0.01|0.05|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive Smokers x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||0.05|0.01|.003
73877498|NCT03863509|147294994|OTHER||Interaction term Coefficient|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.917|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||||.917
74000889|NCT02084056|147550391|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.45|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|91.23|101.97|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||101.97|91.23|<0.0001
74000890|NCT02084056|147550391|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.75|STANDARD_ERROR_OF_MEAN|1.04||0.0002|TWO_SIDED|90.0|90.47|105.63|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||105.63|90.47|0.0002
73877499|NCT03863509|147294995|OTHER||Type III F-test of Fixed Group x Time Ef|49.42|||<|0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 376.099) = 49.420, p \< .001|F (2, 376.099) = 49.420, p \< .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||< .001
73877500|NCT03863509|147294995|OTHER||interaction term coefficient|6.06|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|4.83|7.3|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||7.3|4.83|<0.001
73877501|NCT03863509|147294995|OTHER||interaction term coefficient|5.09|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|3.76|6.42|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||6.42|3.76|<0.001
73877502|NCT03863509|147294995|OTHER||interaction term coefficient|-0.97|STANDARD_ERROR_OF_MEAN|0.602||0.107|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.107
73877503|NCT03863509|147294996|OTHER||Type III F-test of Fixed Group x Time Ef|6.194||||0.002|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2,372.971) = 6.194, p = .002|F (2,372.971) = 6.194, p = .002|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.002
73877504|NCT03863509|147294996|OTHER||interaction term coefficient|-0.005|STANDARD_ERROR_OF_MEAN|0.001||0.003|TWO_SIDED|95.0|-0.01|-0.002|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.002|-0.01|0.003
73877505|NCT03863509|147294996|OTHER||interaction term coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.002||0.001|TWO_SIDED|95.0|-0.01|-0.002|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-0.002|-0.01|0.001
73877506|NCT03863509|147294996|OTHER||interaction term coefficient|-0.001|STANDARD_ERROR_OF_MEAN|0.002||0.582|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.582
73877507|NCT03863509|147294997|OTHER||Type III F-test of Fixed Group x Time E|1.753||||0.175|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried.|FMD responses in e-cigarette users, cigarette users, and never-users controls after adjusting for changes in brachial artery diameter.|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.175
73877508|NCT03863509|147294997|OTHER||interaction term coefficient|0.75|STANDARD_ERROR_OF_MEAN|0.41||0.067|TWO_SIDED|95.0|-0.05|1.56|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Flow Mediated Dilation, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||1.56|-0.05|0.067
73877509|NCT03863509|147294997|OTHER||interaction term coefficient|0.33|STANDARD_ERROR_OF_MEAN|0.44||0.464|TWO_SIDED|95.0|-0.55|1.2|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Flow Mediated Dilation, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.20|-0.55|0.464
73877510|NCT03863509|147294997|OTHER||interaction term coefficient|-0.43|STANDARD_ERROR_OF_MEAN|0.4||0.284|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing effects of group, time, and group x time in FMD, age, sex, race adjusted, for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.284
73877511|NCT03863509|147294998|OTHER||Type III F-test of Fixed Group x Time Ef|8.323|||<|0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 342.847) = 8.323, p = \<.001|F (2,342.847) = 8.323, p = \<.001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||<0.001
73877512|NCT03863509|147294998|OTHER||interaction term coefficient|-6.55|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-9.89|-3.2|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-3.20|-9.89|<0.001
73877513|NCT03863509|147294998|OTHER||interaction term coefficient|-6.11|STANDARD_ERROR_OF_MEAN|1.83||0.001|TWO_SIDED|95.0|-9.71|-2.52|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-2.52|-9.71|0.001
74000891|NCT02084056|147550392|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.96|STANDARD_ERROR_OF_MEAN|1.038|<|0.0001|TWO_SIDED|90.0|92.046|104.257|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||104.257|92.046|<0.0001
74000892|NCT02084056|147550392|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.85|STANDARD_ERROR_OF_MEAN|1.053||0.003|TWO_SIDED|90.0|96.705|115.861|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||115.861|96.705|0.0030
74000893|NCT02084056|147550393|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.48|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|98.426|108.79|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||108.790|98.426|<0.0001
74036860|NCT00696436|147627098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.54||||0.009|TWO_SIDED|95.0|-4.44|-0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.64|-4.44|0.009
74036861|NCT00696436|147627098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.31|||<|0.001|TWO_SIDED|95.0|-6.25|-2.37||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.37|-6.25|<0.001
74036862|NCT00696436|147627098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43||||0.136|TWO_SIDED|95.0|-3.31|0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||0.45|-3.31|0.136
74036863|NCT00696436|147627098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.001|TWO_SIDED|95.0|-5.12|-1.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-1.27|-5.12|0.001
74036864|NCT00696436|147627099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||<|0.001|TWO_SIDED|95.0|-18.07|-11.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-11.76|-18.07|<0.001
74036865|NCT00696436|147627099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.55|||<|0.001|TWO_SIDED|95.0|-17.71|-11.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-11.40|-17.71|<0.001
73877514|NCT03863509|147294998|OTHER||interaction term coefficient|0.44|STANDARD_ERROR_OF_MEAN|1.61||0.787|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.787
73877515|NCT03863509|147294999|OTHER||Type III F-test of Fixed Group x Time Ef|7.26||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 345.918) = 7.260, p = .001|F (2,345.918) = 7.260, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use Outcome measure ln transformed for analysis.||||0.001
73877516|NCT03863509|147294999|OTHER||interaction term coefficient|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.31|-0.08|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.08|-0.31|0.001
74000894|NCT02084056|147550393|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.35|STANDARD_ERROR_OF_MEAN|1.062||0.0019|TWO_SIDED|90.0|91.13|112.708|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||112.708|91.130|0.0019
74036866|NCT00696436|147627099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54||||0.008|TWO_SIDED|95.0|-6.17|-0.92||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.92|-6.17|0.008
74000895|NCT02084056|147550394|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|95.49|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|89.73|101.62|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||101.62|89.73|<0.0001
74000896|NCT02084056|147550394|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.19|STANDARD_ERROR_OF_MEAN|1.05||0.0002|TWO_SIDED|90.0|90.73|106.27|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||106.27|90.73|0.0002
74000897|NCT00190749|147550395|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value for change to last observation|t-test, 2 sided|||||||0.226
74000898|NCT00190749|147550395|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value is change to last observation|t-test, 2 sided|||||||0.030
74000899|NCT00190749|147550395|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value for change to last observation.|ANCOVA|||||||0.204
74000900|NCT00190749|147550396|SUPERIORITY_OR_OTHER|||||||0.184||95.0|||||Pearson's correlation coefficient|||||||0.184
74000901|NCT00190749|147550396|SUPERIORITY_OR_OTHER|||||||0.295||95.0|||||Pearson's correlation coefficient|||||||0.295
74000902|NCT00190749|147550397|SUPERIORITY_OR_OTHER|||||||0.256||95.0|||||Pearson's correlation coefficient|||||||0.256
74000903|NCT00190749|147550397|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||Pearson's correlation coefficient|||||||0.277
74000904|NCT00190749|147550398|SUPERIORITY_OR_OTHER|||||||0.766||95.0|||||Pearson's correlation coefficient|||||||0.766
73877517|NCT03863509|147294999|OTHER||interaction term coefficient|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.33|-0.09|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-0.09|-0.33|0.001
73877518|NCT03863509|147294999|OTHER||interaction term coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.847|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.847
74000905|NCT00190749|147550398|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Pearson's correlation coefficient|||||||0.622
74000906|NCT00190749|147550399|SUPERIORITY_OR_OTHER|||||||0.829||95.0|||||Pearson's correlation coefficient|||||||0.829
74000907|NCT00190749|147550399|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Pearson's correlation coefficient|||||||0.714
74000908|NCT00190749|147550400|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||Pearson's correlation coefficient|||||||0.672
74000909|NCT00190749|147550400|SUPERIORITY_OR_OTHER|||||||0.191||95.0|||||Pearson's correlation coefficient|||||||0.191
74000910|NCT00190749|147550401|SUPERIORITY_OR_OTHER|||||||0.994||95.0|||||Pearson's correlation coefficient|||||||0.994
74000911|NCT00190749|147550401|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||Pearson's correlation coefficient|||||||0.456
74000912|NCT00190749|147550402|SUPERIORITY_OR_OTHER|||||||0.454||95.0|||||Pearson's correlation coefficient|||||||0.454
74000913|NCT00190749|147550402|SUPERIORITY_OR_OTHER|||||||0.974||95.0|||||Pearson's correlation coefficient|||||||0.974
73877519|NCT03863509|147295000|OTHER||Type III F-test of Fixed Group x Time Ef|1.712||||0.182|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 312.081) = 1.712, p = .182|F (2, 312.081) = 1.712, p = .182|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||.182
74000914|NCT00190749|147550403|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||Pearson's correlation coefficient|||||||0.249
74000915|NCT00190749|147550403|SUPERIORITY_OR_OTHER|||||||0.163||95.0|||||Pearson's correlation coefficient|||||||0.163
74000916|NCT00190749|147550404|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||Pearson's correlation coefficient|||||||0.201
74000917|NCT00190749|147550404|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Pearson's correlation coefficient|||||||0.168
74000918|NCT00190749|147550405|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||Pearson's correlation coefficient|||||||0.793
74000919|NCT00190749|147550405|SUPERIORITY_OR_OTHER|||||||0.777||95.0|||||Pearson's correlation coefficient|||||||0.777
74000920|NCT00190749|147550406|SUPERIORITY_OR_OTHER|||||||0.815||95.0|||||Pearson's correlation coefficient|||||||0.815
74000921|NCT00190749|147550406|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Pearson's correlation coefficient|||||||0.675
74000922|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1||||0.393
74000923|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1||||0.033
74000924|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.392||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2||||0.392
74000925|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.129||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2||||0.129
74000926|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 3||||0.956
74000927|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 3||||0.846
74000928|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4||||0.675
74000929|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4||||0.306
74000930|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5||||0.468
74000931|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5||||0.739
74000932|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6||||0.404
74000933|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.711||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6||||0.711
74000934|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7||||0.281
74000935|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7||||0.805
74000936|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 8||||0.844
74000937|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 8||||0.359
74000938|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.642||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9||||0.642
74000939|NCT00190749|147550407|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9||||0.043
74000940|NCT00190749|147550408|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on Least Squares Mean (LSMean) change||||||<.001
74000941|NCT00190749|147550408|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.019
74000942|NCT00190749|147550408|SUPERIORITY_OR_OTHER|||||||0.065||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||||||0.065
74000943|NCT00190749|147550409|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||||||<.001
74000944|NCT00190749|147550409|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.013
74000945|NCT00190749|147550409|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator||||||0.076
74000946|NCT00190749|147550410|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.007
74000947|NCT00190749|147550410|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.266
74000948|NCT00190749|147550410|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator||||||0.239
74000949|NCT00190749|147550411|SUPERIORITY_OR_OTHER|||||||0.274||95.0|||||t-test, 2 sided|Within group p-vales are from t-tests on LSMean change||||||0.274
74000950|NCT00190749|147550411|SUPERIORITY_OR_OTHER|||||||0.105||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change.||||||0.105
74000951|NCT00190749|147550411|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator||||||0.609
74000952|NCT00190749|147550412|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||||||0.406
74000953|NCT00190749|147550412|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.011
74000954|NCT00190749|147550412|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.076
74000955|NCT00190749|147550413|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.456
74000956|NCT00190749|147550413|SUPERIORITY_OR_OTHER|||||||0.712||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.712
74000957|NCT00190749|147550413|SUPERIORITY_OR_OTHER|||||||0.689||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator||||||0.689
74000958|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean||Total Score||||0.111
74000959|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean changes||Total Score||||0.159
74000960|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.951||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Total Score||||0.951
74000961|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Positive Subscale||||0.012
74000962|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean||Positive subscale||||0.002
74000963|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.467||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Positive subscale||||0.467
74000964|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.365||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||Negative subscale||||0.365
74000965|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Negative subscale||||0.846
74000966|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.559||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Negative subscale||||0.559
74000967|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale||||0.150
74000968|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.612||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale||||0.612
74000969|NCT00190749|147550414|SUPERIORITY_OR_OTHER|||||||0.475||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Anxiety-Depression subscale||||0.475
74000970|NCT00190749|147550415|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Within group p-values are from t-tests on LSMean change|t-test, 2 sided|||||||.012
74000971|NCT00190749|147550415|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.010
74000972|NCT00190749|147550415|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of square ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.760
74000973|NCT00190749|147550416|SUPERIORITY_OR_OTHER|||||||0.943||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.943
74000974|NCT00190749|147550416|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.763
74000975|NCT00190749|147550416|SUPERIORITY_OR_OTHER|||||||0.832||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.832
74000976|NCT00190749|147550417|SUPERIORITY_OR_OTHER|||||||0.623||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.623
74000977|NCT00190749|147550417|SUPERIORITY_OR_OTHER|||||||0.853||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.853
74000978|NCT00190749|147550417|SUPERIORITY_OR_OTHER|||||||0.591||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.591
74000979|NCT00190749|147550418|SUPERIORITY_OR_OTHER|||||||0.302||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.302
74000980|NCT00190749|147550418|SUPERIORITY_OR_OTHER|||||||0.922||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.922
74000981|NCT00190749|147550418|SUPERIORITY_OR_OTHER|||||||0.479||95.0|||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.479
74000982|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1||||0.004
74000983|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1||||0.001
74000984|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares, ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 1||||0.549
74000985|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2||||0.011
74000986|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2||||0.009
74000987|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 2||||0.793
74000988|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3||||0.045
74000989|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3||||0.027
74000990|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.699||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 3||||0.699
74000991|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 4||||0.002
74000992|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||ITem 4||||0.019
74000993|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 4||||0.733
74000994|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5||||0.034
74000995|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.235||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5||||0.235
74000996|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.532||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 5||||0.532
74000997|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.242||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6||||0.242
74000998|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6||||0.186
74000999|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 6||||0.799
74001000|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7||||0.097
74001001|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7||||0.214
73877520|NCT03863509|147295000|OTHER||interaction term coefficient|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.07|TWO_SIDED|95.0|-0.09|0.004|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||0.004|-0.09|0.07
73877521|NCT03863509|147295000|OTHER||interaction term coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.196|TWO_SIDED|95.0|-0.09|0.02|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||0.02|-0.09|0.196
73877522|NCT03863509|147295000|OTHER||interaction term coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.02||0.69|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.69
73877523|NCT03863509|147295001|OTHER||Type III F-test of Fixed Group x Time Ef|4.096||||0.017|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.239) = 4.096, p = .017|F (2, 373.239) = 4.096, p = .017|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.017
73877524|NCT03863509|147295001|OTHER||interaction term coefficient|-3.04|STANDARD_ERROR_OF_MEAN|1.09||0.005|TWO_SIDED|95.0|-5.18|-0.91|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||-0.91|-5.18|0.005
73877525|NCT03863509|147295001|OTHER||interaction term coefficient|-1.29|STANDARD_ERROR_OF_MEAN|1.18||0.274|TWO_SIDED|95.0|-3.61|1.03|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.03|-3.61|0.274
73877526|NCT03863509|147295001|OTHER||interaction term coefficient|1.75|STANDARD_ERROR_OF_MEAN|1.06||0.098|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.098
73877527|NCT03863509|147295002|OTHER||Type III F-test of Fixed Group x Time Ef|0.26||||0.771|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.434) = 0.260, p = .771|F (2, 373.434) = 0.260, p = .771|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||.771
73877528|NCT03863509|147295002|OTHER||interaction term coefficient|-0.12|STANDARD_ERROR_OF_MEAN|1.14||0.918|TWO_SIDED|95.0|-2.35|2.12|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||2.12|-2.35|0.918
73877529|NCT03863509|147295002|OTHER||interaction term coefficient|-0.8|STANDARD_ERROR_OF_MEAN|1.23||0.518|TWO_SIDED|95.0|-3.22|1.63|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.63|-3.22|0.518
73877530|NCT03863509|147295002|OTHER||interaction term coefficient|-0.68|STANDARD_ERROR_OF_MEAN|1.11||0.539|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.539
73957185|NCT02512042|147450302|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population|Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.5|0.13||||||||0.13|-0.50|
73957186|NCT01194258|147450303|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was set at 0.40.|LS Mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.041||0.3876|TWO_SIDED|95.0|-0.12|0.05|||Mixed Models Analysis|||Approximately 110 participants were planned to be enrolled to allow approximately 88 participants to complete both treatment periods. Assuming a dropout rate of ≤20%, an intra-participant correlation of 0.80, a standard deviation of 1.2, and a true difference of 0, the study would have \>90% power to show that either Lispro-PH20 or Aspart-PH20 (each tested separately) was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.||0.05|-0.12|0.3876
73957187|NCT01656304|147450343|SUPERIORITY_OR_OTHER||Rate|0.333|STANDARD_ERROR_OF_MEAN|0.1217|||TWO_SIDED|80.0|0.2|0.5||||||||.50|.20|
73957188|NCT05826431|147450390|OTHER||Mean Difference (Final Values)|18.65||||0.153|TWO_SIDED||||||Paired samples t-test|||Study analyses were conducted using IBM SPSS Statistics Version 29. Frequencies and descriptive data were tabulated to describe the sample and quantify device use, satisfaction, and perceived impact. Qualitative responses regarding usability and feasibility were summarized based on the themes of the responses.||||0.153
73957189|NCT05826431|147450391|OTHER||Mean Difference (Final Values)|0.61||||0.103|TWO_SIDED||||||Paired samples t-test|||||||0.103
73957190|NCT05826431|147450393|OTHER|Single group, frequencies, and descriptive data|Mean Difference (Final Values)|4.22||||0.083|TWO_SIDED||||||Paired samples t-test|||||||.083
73957191|NCT05826431|147450394|OTHER||Mean Difference (Final Values)|-0.26||||441|TWO_SIDED||||||Paired samples t-test|||||||0441
73957192|NCT05826431|147450395|OTHER||Mean Difference (Final Values)|2.61||||0.095|TWO_SIDED||||||Paired samples t-test|||||||0.095
73957193|NCT05826431|147450396|OTHER||Mean Difference (Final Values)|0.03||||0.487|TWO_SIDED||||||Paired samples t-test|||||||0.487
73957194|NCT05826431|147450397|OTHER||Mean Difference (Final Values)|-0.06||||0.483|TWO_SIDED||||||Paired samples t-test|||||||0.483
73957195|NCT05826431|147450398|OTHER||Mean Difference (Final Values)|-2.82||||0.0483|TWO_SIDED||||||Paired samples t-test|||||||.0483
73957196|NCT05826431|147450399|OTHER||Mean Difference (Final Values)|-0.42||||0.123|TWO_SIDED||||||Paired samples t-test|||||||0.123
73877531|NCT03863509|147295003|OTHER||Type III F-test of Fixed Group x Time Ef|7.157||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 375.412) = 7.157, p = .001|F (2, 375.412) = 7.157, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.001
74001002|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.827||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 7||||0.827
74001003|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.151||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8||||0.151
74001004|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8||||0.071
74001005|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.629||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 8||||0.629
74001006|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9||||0.036
74001007|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9||||0.112
74001008|NCT00190749|147550419|SUPERIORITY_OR_OTHER|||||||0.806||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 9||||0.806
74001009|NCT00190749|147550420|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.156
74001010|NCT00190749|147550420|SUPERIORITY_OR_OTHER|||||||0.829||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.829
74001011|NCT00190749|147550420|SUPERIORITY_OR_OTHER|||||||0.352||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.352
74001012|NCT00190749|147550421|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.740
73877532|NCT03863509|147295003|OTHER||interaction term coefficient|-3.39|STANDARD_ERROR_OF_MEAN|1.04||0.001|TWO_SIDED|95.0|-5.43|-1.35|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||-1.35|-5.43|0.001
73877533|NCT03863509|147295003|OTHER||interaction term coefficient|-0.32|STANDARD_ERROR_OF_MEAN|1.12||0.778|TWO_SIDED|95.0|-2.53|1.89|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.89|-2.53|0.778
73877534|NCT03863509|147295003|OTHER||interaction term coefficient|3.08|STANDARD_ERROR_OF_MEAN|1.08||0.002|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.002
74001013|NCT00190749|147550421|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|Within group p-values are frm t-tests on LSMean change||||||0.760
74001014|NCT00190749|147550421|SUPERIORITY_OR_OTHER|||||||0.997||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.997
74001015|NCT00190749|147550422|SUPERIORITY_OR_OTHER|||||||0.176||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.176
74001016|NCT00190749|147550422|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.237
74001017|NCT00190749|147550422|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.996
74001018|NCT00190749|147550423|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.027
74001019|NCT00190749|147550423|SUPERIORITY_OR_OTHER|||||||0.545||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.545
74001020|NCT00190749|147550423|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.024
74001021|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total||||0.009
74001022|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total||||0.959
74001023|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline TReatment Pooled Investigator|ANCOVA|||HDL particles, total||||0.038
74001024|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL||||0.013
74001025|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.928||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL||||0.928
74001026|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||IDL||||0.049
74001027|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL||||0.009
74001028|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.662||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL||||0.662
74001029|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Medium small LDL||||0.12
74001030|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.099||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL||||0.099
74001031|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.304||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL||||0.304
74001032|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Small LDL||||0.024
74001033|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.176||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Very small LDL||||0.176
74001034|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.246||95.0|||||t-test, 2 sided|Withn group p-values are from t-tests on LSMean change||Very small LDL||||0.246
74001035|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|ANCOVA|||Very small LDL||||0.033
74001036|NCT00190749|147550424|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size||||<0.001
74001037|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size||||0.047
74001038|NCT00190749|147550424|SUPERIORITY_OR_OTHER|||||||0.221||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||VLDL mean particle size||||0.221
74001039|NCT00825825|147550432|SUPERIORITY_OR_OTHER|||||||0.000704||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.000704
74001040|NCT00825825|147550433|SUPERIORITY_OR_OTHER|||||||1.62e-05||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.0000162
74001041|NCT00825825|147550434|SUPERIORITY_OR_OTHER|||||||9.36e-06||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.||||0.00000936
74001042|NCT00825825|147550435|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.||||0.0279
74036867|NCT00696436|147627099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.43|||<|0.001|TWO_SIDED|95.0|-8.09|-2.78||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.78|-8.09|<0.001
73877535|NCT03863509|147295004|OTHER||Type III F-test of Fixed Group x Time Ef|4.317||||0.014|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.170) = 4.317, p = .014|F (2, 373.170) = 4.317, p = .014|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.014
74001043|NCT00825825|147550436|SUPERIORITY_OR_OTHER|||||||0.00124||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and placebo medication periods.||||0.00124
74001044|NCT00825825|147550437|SUPERIORITY_OR_OTHER|||||||6.33e-05||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the placebo and citalopram medication periods.||||0.0000633
74001045|NCT00825825|147550438|SUPERIORITY_OR_OTHER|||||||0.0241||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.0241
74001046|NCT02697292|147550439|SUPERIORITY||Odds Ratio (OR)|10.5||||0.044|TWO_SIDED|95.0|1.1|98.9|||t-test, 1 sided|||||98.9|1.1|0.044
74001047|NCT02697292|147550440|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
74001048|NCT01049217|147550491|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.191||0.709|TWO_SIDED|95.0|-0.3|0.45|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with terms of treatment, pooled site, dideoxynucleoside analogue (D-drug) anti-retroviral agent (ART) use and baseline score.||0.45|-0.30|0.7090
74001049|NCT01049217|147550492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5049|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.5049
74001050|NCT01049217|147550493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4271|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.4271
74001051|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.095||0.2084|TWO_SIDED|95.0|-0.31|0.07|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.31|0.2084
74001052|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.126||0.1516|TWO_SIDED|95.0|-0.43|0.07|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.43|0.1516
74001053|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0468|TWO_SIDED|95.0|-0.56|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||-0.00|-0.56|0.0468
74001054|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.177||0.1224|TWO_SIDED|95.0|-0.62|0.07|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.62|0.1224
74001055|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.184||0.0373|TWO_SIDED|95.0|-0.75|-0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||-0.02|-0.75|0.0373
74001056|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.199||0.166|TWO_SIDED|95.0|-0.67|0.12|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.12|-0.67|0.1660
74001057|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.214||0.3246|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.21|-0.63|0.3246
74001058|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.219||0.4879|TWO_SIDED|95.0|-0.58|0.28|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.28|-0.58|0.4879
74001059|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.223||0.2669|TWO_SIDED|95.0|-0.69|0.19|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.19|-0.69|0.2669
73877536|NCT03863509|147295004|OTHER||interaction term coefficient|-5.08|STANDARD_ERROR_OF_MEAN|2.1||0.016|TWO_SIDED|95.0|-9.21|-0.95|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.95|-9.21|0.016
73877537|NCT03863509|147295004|OTHER||interaction term coefficient|0.01|STANDARD_ERROR_OF_MEAN|2.28||0.998|TWO_SIDED|95.0|-4.47|4.48|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||4.48|-4.47|0.998
73877538|NCT03863509|147295004|OTHER||interaction term coefficient|5.09|STANDARD_ERROR_OF_MEAN|2.04||0.013|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.013
73877539|NCT03863509|147295005|OTHER||Type III F-test of Fixed Group x Time Ef|6.694||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2,376.779) = 6.694, p = .001|F ((2,376.779) = 6.694, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and-between-group responses following product use Outcome measure ln transformed for analysis.||||0.001
73877540|NCT03863509|147295005|OTHER||interaction term coefficient|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.001|TWO_SIDED|95.0|-0.14|-0.04|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.04|-0.14|0.001
73877541|NCT03863509|147295005|OTHER||interaction term coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.555|TWO_SIDED|95.0|-0.08|0.04|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||0.04|-0.08|0.555
73877542|NCT03863509|147295005|OTHER||interaction term coefficient|0.007|STANDARD_ERROR_OF_MEAN|0.03||0.007|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.007
73877543|NCT03863509|147295006|OTHER||||||<|0.001||||||ANCOVA for group differences|ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 12.869, p \< .001||||||< .001
73877544|NCT03863509|147295006|OTHER||Mean Difference (Final Values)|1.352||||0.269|TWO_SIDED|95.0|-1.048|3.752|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||3.752|-1.048|0.269
73877545|NCT03863509|147295006|OTHER||Mean Difference (Final Values)|-5.575|||<|0.001|TWO_SIDED|95.0|-8.37|-2.78|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||-2.780|-8.37|<0.001
73877546|NCT03863509|147295006|OTHER||Mean Difference (Final Values)|-6.927|||<|0.001|TWO_SIDED|95.0|-9.672|-4.183|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried.||Exclusive E-Cig Users minus Exclusive Smokers||-4.183|-9.672|<0.001
73877547|NCT03863509|147295007|OTHER|||||||0.035|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 361) = 3.392, p = .035|||Group difference did not survive correction for false discovery rate at .05, therefore not followed with post-hoc pairwise comparisons.|||.035
73877548|NCT03863509|147295008|OTHER|||||||0.549|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 0.601, p = .549||||||.549
73957197|NCT04771273|147450406|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|3.47||||0.001|TWO_SIDED|95.0|1.66|7.25||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||7.25|1.66|0.0010
73957198|NCT04771273|147450406|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|9.52|||<|0.0001|TWO_SIDED|95.0|4.35|20.85||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||20.85|4.35|<0.0001
73957199|NCT04771273|147450406|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|7.07|||<|0.0001|TWO_SIDED|95.0|3.1|16.16||The p-value reported is considered nominal.|Regression, Logistic|||The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||16.16|3.10|<.0001
73957200|NCT04771273|147450406|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
74001060|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.219||0.5452|TWO_SIDED|95.0|-0.56|0.3|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.30|-0.56|0.5452
74001061|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.229||0.5469|TWO_SIDED|95.0|-0.59|0.31|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.31|-0.59|0.5469
73877549|NCT03863509|147295009|OTHER|||||||0.022|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 381) = 3.877, p = .022|||Group difference tested after correction for false discovery rate at .05, therefore we followed with post-hoc pairwise comparisons.|||.022
73877550|NCT03863509|147295009|OTHER|||||||0.952|||||||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||||0.952
74001062|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.24||0.7843|TWO_SIDED|95.0|-0.54|0.41|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.41|-0.54|0.7843
74001063|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.24||0.9008|TWO_SIDED|95.0|-0.5|0.44|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.44|-0.50|0.9008
74001064|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.24||0.9064|TWO_SIDED|95.0|-0.45|0.5|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.45|0.9064
74001065|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.243||0.7205|TWO_SIDED|95.0|-0.57|0.39|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.39|-0.57|0.7205
74001066|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.259||0.4334|TWO_SIDED|95.0|-0.71|0.31|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.31|-0.71|0.4334
74001067|NCT01049217|147550494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.199||0.8402|TWO_SIDED|95.0|-0.43|0.35|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.35|-0.43|0.8402
74001068|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.085||0.3098|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.08|-0.25|0.3098
74001069|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.118||0.2429|TWO_SIDED|95.0|-0.37|0.09|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.09|-0.37|0.2429
74001070|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.137||0.0504|TWO_SIDED|95.0|-0.54|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.00|-0.54|0.0504
74036868|NCT00696436|147627099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.18||||0.018|TWO_SIDED|95.0|-5.81|-0.55||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.55|-5.81|0.018
73877551|NCT03863509|147295009|OTHER|||||||0.014|||||||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||post hoc pairwise group comparisons.. Never Users minus Exclusive Smokers||||0.014
73877552|NCT03863509|147295009|OTHER|||||||0.011||||||Age, sex, and race were covaried|ANCOVA post-hoc pairwise group compariso|||Exclusive E-Cig Users minus Exclusive Smokers||||0.011
73877553|NCT03863509|147295010|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Outcome variable log-transformed for analysis. Test for group difference: F (2, 381) = 33.442, p \< .001|||Group difference tested for false discovery rate at .05 and followed with post-hoc pairwise comparisons.|||< .001
73877554|NCT03863509|147295010|OTHER||Mean Difference (Final Values)|0.18||||0.013|TWO_SIDED|95.0|0.039|0.322|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried|Estimated marginal mean differences (log-transformed scale)|Never Users minus Exclusive E-Cig Users:||0.322|0.039|0.013
73877555|NCT03863509|147295010|OTHER||Mean Difference (Final Values)|0.679|||<|0.001|TWO_SIDED|95.0|0.514|0.844|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried|Estimated marginal mean differences (log-transformed scale)|Never Users minus Exclusive Smokers||0.844|0.514|<0.001
74001071|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.164||0.1141|TWO_SIDED|95.0|-0.58|0.06|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.06|-0.58|0.1141
74001072|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.173||0.0667|TWO_SIDED|95.0|-0.66|0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.02|-0.66|0.0667
74001073|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.189||0.2104|TWO_SIDED|95.0|-0.61|0.13|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.13|-0.61|0.2104
74001074|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.197||0.483|TWO_SIDED|95.0|-0.53|0.25|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.25|-0.53|0.4830
74001075|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.203||0.5757|TWO_SIDED|95.0|-0.51|0.29|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.29|-0.51|0.5757
74001076|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.208||0.3231|TWO_SIDED|95.0|-0.62|0.2|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.20|-0.62|0.3231
74001077|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.212||0.3143|TWO_SIDED|95.0|-0.63|0.2|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.20|-0.63|0.3143
74001078|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.222||0.63|TWO_SIDED|95.0|-0.54|0.33|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.33|-0.54|0.6300
74001079|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.227||0.5752|TWO_SIDED|95.0|-0.57|0.32|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.32|-0.57|0.5752
74001080|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.219||0.8905|TWO_SIDED|95.0|-0.46|0.4|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.40|-0.46|0.8905
74001081|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.228||0.9991|TWO_SIDED|95.0|-0.45|0.45|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.45|-0.45|0.9991
74036869|NCT00696436|147627099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07|||<|0.001|TWO_SIDED|95.0|-7.73|-2.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.42|-7.73|<0.001
74036870|NCT00696436|147627100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.36|||<|0.001|TWO_SIDED|95.0|-10.91|-7.81||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.81|-10.91|<0.001
74036871|NCT00696436|147627100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.58|||<|0.001|TWO_SIDED|95.0|-10.12|-7.04||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.04|-10.12|<0.001
74036872|NCT00696436|147627100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.011|TWO_SIDED|95.0|-2.99|-0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.40|-2.99|0.011
74036873|NCT00696436|147627100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|||<|0.001|TWO_SIDED|95.0|-3.67|-1.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.02|-3.67|<0.001
74036874|NCT00696436|147627100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.166|TWO_SIDED|95.0|-2.19|0.38||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.38|-2.19|0.166
74036875|NCT00696436|147627100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.02|TWO_SIDED|95.0|-2.88|-0.24||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.24|-2.88|0.020
74036876|NCT00696436|147627101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51|||<|0.001|TWO_SIDED|95.0|-9.33|-5.69||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.69|-9.33|<0.001
74090794|NCT00076804|147735656|SUPERIORITY_OR_OTHER|||||||0.42||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.42
74090795|NCT00076804|147735657|SUPERIORITY_OR_OTHER|||||||0.89||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.89
73877556|NCT03863509|147295010|OTHER||Mean Difference (Final Values)|0.498|||<|0.001|TWO_SIDED|95.0|0.336|0.66|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race/ethnicity were covaried|"Estimated marginal mean differences (log-transformed scale)"|Exclusive E-Cig users minus Exclusive Smokers||0.660|0.336|<0.001
73877557|NCT03863509|147295011|OTHER|||||||0.15|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 361) = 1.904, p = .150||||||.150
74001082|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.228||0.8927|TWO_SIDED|95.0|-0.48|0.42|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.42|-0.48|0.8927
74036877|NCT00696436|147627101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.21|||<|0.001|TWO_SIDED|95.0|-8.03|-4.39||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-4.39|-8.03|<0.001
74036878|NCT00696436|147627101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18||||0.005|TWO_SIDED|95.0|-3.69|-0.67||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.67|-3.69|0.005
74036879|NCT00696436|147627101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.17|||<|0.001|TWO_SIDED|95.0|-4.69|-1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.64|-4.69|<0.001
74036880|NCT00696436|147627101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.257|TWO_SIDED|95.0|-2.39|0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.64|-2.39|0.257
74036881|NCT00696436|147627101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.017|TWO_SIDED|95.0|-3.39|-0.33||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.33|-3.39|0.017
74090796|NCT00076804|147735658|SUPERIORITY_OR_OTHER|||||||0.14||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.14
73957201|NCT04771273|147450406|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73877558|NCT03863509|147295012|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 385) = 17.872, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons. Estimated marginal mean differences:|||< .001
73957202|NCT04771273|147450406|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0008|||||||MCP-Mod exponential -2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0008
74001083|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.245||0.8067|TWO_SIDED|95.0|-0.54|0.42|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.42|-0.54|0.8067
74001084|NCT01049217|147550495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.19||0.9009|TWO_SIDED|95.0|-0.35|0.4|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.40|-0.35|0.9009
74001085|NCT01049217|147550496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.177||0.0948|TWO_SIDED|95.0|-0.64|0.05|||ANCOVA|||Change at Week 4, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.64|0.0948
74001086|NCT01049217|147550496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.203||0.4167|TWO_SIDED|95.0|-0.57|0.23|||ANCOVA|||Change at Week 8, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.23|-0.57|0.4167
74001087|NCT01049217|147550496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.226||0.8179|TWO_SIDED|95.0|-0.39|0.5|||ANCOVA|||Change at Week 12, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.39|0.8179
74001088|NCT01049217|147550496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.209||0.6913|TWO_SIDED|95.0|-0.33|0.5|||ANCOVA|||Change at Week 16, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.33|0.6913
74001089|NCT01049217|147550496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.203||0.9475|TWO_SIDED|95.0|-0.39|0.41|||ANCOVA|||Change at Endpoint, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.41|-0.39|0.9475
74001090|NCT01049217|147550496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.204||0.7412|TWO_SIDED|95.0|-0.47|0.33|||ANCOVA|||Change at Week 4, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.33|-0.47|0.7412
73877559|NCT03863509|147295012|OTHER||Mean Difference (Final Values)|-3.632||||0.003|TWO_SIDED|95.0|-6.019|-1.245|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||-1.245|-6.019|0.003
74001091|NCT01049217|147550496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.213||0.9715|TWO_SIDED|95.0|-0.41|0.43|||ANCOVA|||Change at Week 8, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.43|-0.41|0.9715
74001092|NCT01049217|147550496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.218||0.8163|TWO_SIDED|95.0|-0.38|0.48|||ANCOVA|||Change at Week 12, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.48|-0.38|0.8163
74001093|NCT01049217|147550496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.204||0.3682|TWO_SIDED|95.0|-0.22|0.58|||ANCOVA|||Change at Week 16, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.58|-0.22|0.3682
74001094|NCT01049217|147550496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.199||0.3511|TWO_SIDED|95.0|-0.21|0.58|||ANCOVA|||Change at Endpoint, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.58|-0.21|0.3511
74001095|NCT01049217|147550497|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9686|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Burning: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9686
74001096|NCT01049217|147550497|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4476|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Squeezing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.3|-0.6|0.4476
74036882|NCT00696436|147627102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||<|0.001|TWO_SIDED|95.0|-17.3|-12.54||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-12.54|-17.30|<0.001
73877560|NCT03863509|147295012|OTHER||Mean Difference (Final Values)|-8.38|||<|0.001|TWO_SIDED|95.0|-11.14|-5.62|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive Smokers||-5.62|-11.14|<0.001
74001097|NCT01049217|147550497|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.563|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Pressure: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.3|-0.6|0.5630
74001098|NCT01049217|147550497|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9937|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Electric Shocks: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9937
74036883|NCT00696436|147627102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.63|||<|0.001|TWO_SIDED|95.0|-15.99|-11.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-11.27|-15.99|<0.001
73877561|NCT03863509|147295012|OTHER||Mean Difference (Final Values)|-4.748||||0.001|TWO_SIDED|95.0|-7.456|-2.04|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||-2.040|-7.456|0.001
73877562|NCT03863509|147295013|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||< .001
73877563|NCT03863509|147295013|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|age, sex and race were covaried||Never Users minus Exclusive E-Cig Users||1.824|0.733|<0.001
73877564|NCT03863509|147295013|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
73877565|NCT03863509|147295013|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
74001099|NCT01049217|147550497|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.8718|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Stabbing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.8718
74001100|NCT01049217|147550497|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.8241|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Change at Endpoint, Light Touching: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.4|-0.5|0.8241
74001101|NCT01049217|147550497|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3164|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Change at Endpoint, Pressure of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.2|-0.7|0.3164
74001102|NCT01049217|147550497|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.8996|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Cold of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.8996
74001103|NCT01049217|147550497|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9676|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Pins and Needles: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9676
73877566|NCT03863509|147295014|OTHER|||||||0.199|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 1.621, p = .199||||||.199
74001104|NCT01049217|147550497|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9091|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Tingling: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9091
73877567|NCT03863509|147295015|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p\< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||<0.001
73877568|NCT03863509|147295015|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive E-Cig users||1.824|0.733|<0.001
73877569|NCT03863509|147295015|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|age, sex, race covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
73877570|NCT03863509|147295015|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
73877571|NCT03863509|147295016|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p\< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||<0.001
73877572|NCT03863509|147295016|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|Age, sex, race were covaried||Never Users minus Exclusive E-Cig Users||1.824|0.733|<0.001
73877573|NCT03863509|147295016|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
73877574|NCT03863509|147295016|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
73877575|NCT03863509|147295017|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 344) = 10.075, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons. Estimated marginal mean differences:|||<0.001
73877576|NCT00141102|147295018|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.32|||<|0.0001|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||<0.0001
73877577|NCT00141102|147295019|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||<0.0001
73877578|NCT00141102|147295020|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.019|STANDARD_ERROR_OF_MEAN|0.023||0.4146|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.03|-0.06|0.4146
73877579|NCT00141102|147295021|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.29||||0.1132|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.1132
74001105|NCT01049217|147550498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Duration of Spontaneous Pain: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.7300
74001106|NCT01049217|147550498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0559|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Number of Pain Attacks: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.0559
74036884|NCT00696436|147627102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.86||||0.005|TWO_SIDED|95.0|-4.85|-0.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.87|-4.85|0.005
74036885|NCT00696436|147627102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||<|0.001|TWO_SIDED|95.0|-6.8|-2.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-2.73|-6.80|<0.001
73877580|NCT00141102|147295023|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.0495|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.0495
73877581|NCT00141102|147295024|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.0006|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.0006
73877582|NCT00141102|147295025|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.406|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.36|0.45|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.45|0.36|<0.0001
73877583|NCT00141102|147295026|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.118|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|0.98|1.25|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||1.25|0.98|<0.0001
74001107|NCT01049217|147550499|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.025||0.9686|TWO_SIDED|95.0|-0.05|0.05|||ANCOVA|||Change at Endpoint, Burning Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.05|0.9686
74001108|NCT01049217|147550499|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.022||0.4711|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|||Change at Endpoint, Pressing Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.06|0.4711
74001109|NCT01049217|147550499|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.023||0.9215|TWO_SIDED|95.0|-0.04|0.05|||ANCOVA|||Change at Endpoint, Paroxysmal Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.04|0.9215
74001110|NCT01049217|147550499|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.6042|TWO_SIDED|95.0|-0.05|0.03|||ANCOVA|||Change at Endpoint, Evoked Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.05|0.6042
74036886|NCT00696436|147627102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.119|TWO_SIDED|95.0|-3.55|0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.40|-3.55|0.119
74036887|NCT00696436|147627102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|||<|0.001|TWO_SIDED|95.0|-5.49|-1.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.45|-5.49|<0.001
74036888|NCT00696436|147627103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.81|||<|0.001|TWO_SIDED|95.0|-11.48|-8.13||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-8.13|-11.48|<0.001
74036889|NCT00696436|147627103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.96|||<|0.001|TWO_SIDED|95.0|-10.63|-7.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.30|-10.63|<0.001
74036890|NCT00696436|147627103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.006|TWO_SIDED|95.0|-3.39|-0.58||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.58|-3.39|0.006
74036891|NCT00696436|147627103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57|||<|0.001|TWO_SIDED|95.0|-4.0|-1.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.14|-4.00|<0.001
74036892|NCT00696436|147627103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.107|TWO_SIDED|95.0|-2.53|0.25||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.25|-2.53|0.107
74036893|NCT00696436|147627103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73||||0.017|TWO_SIDED|95.0|-3.15|-0.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.30|-3.15|0.017
74036894|NCT00696436|147627104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.56|-10.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-10.45|-15.56|<0.001
74036895|NCT00696436|147627104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.97|||<|0.001|TWO_SIDED|95.0|-14.51|-9.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-9.43|-14.51|<0.001
74036896|NCT00696436|147627104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.194|TWO_SIDED|95.0|-3.56|0.72||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.72|-3.56|0.194
73877584|NCT00141102|147295027|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.748|||<|0.0001|TWO_SIDED|95.0|1.96|3.84|||Cochran-Mantel-Haenszel|Stratified by history of GD ulceration and by region.||||3.84|1.96|<0.0001
73877585|NCT00141102|147295028|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|3.329|||<|0.0001|TWO_SIDED|95.0|2.156|5.141|||Fisher Exact|||GGT||5.141|2.156|<0.0001
73877586|NCT00141102|147295028|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|1.509||||0.3809|TWO_SIDED|95.0|0.618|3.684|||Fisher Exact|||AST||3.684|0.618|0.3809
74001111|NCT01049217|147550499|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.024||0.9394|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||Change at Endpoint, P/D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.04|-0.05|0.9394
74001112|NCT01049217|147550499|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.7801|TWO_SIDED|95.0|-0.04|0.03|||ANCOVA|||Change at Endpoint, Total Score: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.04|0.7801
74001113|NCT01049217|147550500|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.44|STANDARD_ERROR_OF_MEAN|6.58||0.6012|TWO_SIDED||||||ANCOVA|||Endpoint TST: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.6012
74001114|NCT01049217|147550500|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|1.89||0.0534|TWO_SIDED||||||ANCOVA|||Endpoint MIS: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0534
74001115|NCT01049217|147550501|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.62||0.0966|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0966
74001116|NCT01049217|147550502|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|0.51||0.0611|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0611
74001117|NCT01049217|147550503|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8436.0|STANDARD_ERROR_OF_MEAN|6855.2||0.2195|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.2195
74001118|NCT01049217|147550504|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.|LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.66||0.8241|TWO_SIDED||||||ANCOVA|||||||0.8241
74001119|NCT01049217|147550505|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|2.052||0.8528|TWO_SIDED|95.0|-4.42|3.66|||ANCOVA|||Change at Endpoint, Sleep Disturbance: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.66|-4.42|0.8528
74001120|NCT01049217|147550505|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.88|STANDARD_ERROR_OF_MEAN|3.179||0.365|TWO_SIDED|95.0|-3.37|9.14|||ANCOVA|||Change at Endpoint, Snoring: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||9.14|-3.37|0.3650
74090797|NCT00076804|147735659|SUPERIORITY_OR_OTHER|||||||0.61||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.61
73877587|NCT00141102|147295028|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.089||||0.0264|TWO_SIDED|95.0|1.081|4.038|||Fisher Exact|||ALT||4.038|1.081|0.0264
74001121|NCT01049217|147550505|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.89|STANDARD_ERROR_OF_MEAN|2.525||0.7237|TWO_SIDED|95.0|-4.07|5.86|||ANCOVA|||Change at Endpoint, SOB: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.86|-4.07|0.7237
74001122|NCT01049217|147550505|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.165||0.2783|TWO_SIDED|95.0|-0.5|0.15|||ANCOVA|||Change at Endpoint, Quantity: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.15|-0.50|0.2783
73877588|NCT00141102|147295029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.144|STANDARD_ERROR_OF_MEAN|0.697|<|0.0001|TWO_SIDED|95.0|-11.51|-8.78|||ANCOVA|||GGT||-8.78|-11.51|<0.0001
73877589|NCT00141102|147295029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.391|STANDARD_ERROR_OF_MEAN|0.281|<|0.0001|TWO_SIDED|95.0|-2.94|-1.84|||ANCOVA|||AST||-1.84|-2.94|<0.0001
74001123|NCT01049217|147550505|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.02|STANDARD_ERROR_OF_MEAN|2.611||0.2475|TWO_SIDED|95.0|-2.11|8.16|||ANCOVA|||Change at Endpoint, Adequacy: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||8.16|-2.11|0.2475
74001124|NCT01049217|147550505|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.16|STANDARD_ERROR_OF_MEAN|1.933||0.5492|TWO_SIDED|95.0|-2.64|4.96|||ANCOVA|||Change at Endpoint, Somnolence: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.96|-2.64|0.5492
74001125|NCT01049217|147550505|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.614||0.9113|TWO_SIDED|95.0|-3.0|3.36|||ANCOVA|||Change at Endpoint, Sleep Problems Index: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.36|-3.00|0.9113
73877590|NCT00141102|147295029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.364|STANDARD_ERROR_OF_MEAN|0.428|<|0.0001|TWO_SIDED|95.0|-7.2|-5.52|||ANCOVA|||ALT||-5.52|-7.20|<0.0001
73877591|NCT00141102|147295030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.565|STANDARD_ERROR_OF_MEAN|1.366||0.6795|TWO_SIDED|95.0|-2.11|3.24|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||3.24|-2.11|0.6795
74001126|NCT01049217|147550506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7399|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Endpoint: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.7399
74001127|NCT01049217|147550507|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.386||0.8258|TWO_SIDED|95.0|-0.67|0.84|||ANCOVA|||Change at Endpoint, HADS-A: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.84|-0.67|0.8258
74001128|NCT01049217|147550507|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.372||0.084|TWO_SIDED|95.0|-0.09|1.38|||ANCOVA|||Change at Endpoint, HADS-D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.38|-0.09|0.0840
74001129|NCT01049217|147550508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|2.393||0.6114|TWO_SIDED|95.0|-3.49|5.92|||ANCOVA|||Change at Endpoint, Ph Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.92|-3.49|0.6114
74001130|NCT01049217|147550508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|2.522||0.8209|TWO_SIDED|95.0|-4.39|5.53|||ANCOVA|||Change at Endpoint, R-P: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.53|-4.39|0.8209
74001131|NCT01049217|147550508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|2.335||0.9737|TWO_SIDED|95.0|-4.52|4.67|||ANCOVA|||Change at Endpoint, BP: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.67|-4.52|0.9737
74001132|NCT01049217|147550508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|1.937||0.6966|TWO_SIDED|95.0|-3.05|4.57|||ANCOVA|||Change at Endpoint, GH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.57|-3.05|0.6966
74001133|NCT01049217|147550508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.807||0.8569|TWO_SIDED|95.0|-1.44|1.73|||ANCOVA|||Change at Endpoint, Ph C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.73|-1.44|0.8569
74001134|NCT01049217|147550508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|1.847||0.4734|TWO_SIDED|95.0|-4.96|2.31|||ANCOVA|||Change at Endpoint, Vit: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||2.31|-4.96|0.4734
74001135|NCT01049217|147550508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|2.159||0.3625|TWO_SIDED|95.0|-6.22|2.28|||ANCOVA|||Change at Endpoint, So Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||2.28|-6.22|0.3625
74001136|NCT01049217|147550508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|2.543||0.2736|TWO_SIDED|95.0|-2.21|7.79|||ANCOVA|||Change at Endpoint, R-E: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||7.79|-2.21|0.2736
74001137|NCT01049217|147550508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|1.811||0.8199|TWO_SIDED|95.0|-3.98|3.15|||ANCOVA|||Change at Endpoint, MnH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.15|-3.98|0.8199
74001138|NCT01049217|147550508|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.967||0.9361|TWO_SIDED|95.0|-1.82|1.98|||ANCOVA|||Change at Endpoint, Mn C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.98|-1.82|0.9361
74036897|NCT00696436|147627104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.001|TWO_SIDED|95.0|-5.84|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.46|-5.84|0.001
74001139|NCT02495792|147550531|OTHER||Risk Ratio (RR)|5.98|||||TWO_SIDED|95.0|1.6|21.7||||||||21.7|1.6|
74001140|NCT02909764|147550553|OTHER|||||||0.3|||||||ANOVA|||||||0.30
74001141|NCT02909764|147550554|OTHER|Yates's chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.|||||<|0.05|||||||Chi-squared|||Yates's chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.||||<0.05
74001142|NCT02909764|147550555|OTHER|||||||0.32|||||||ANOVA|||||||0.32
74001143|NCT02909764|147550556|OTHER|||||||0.77|||||||ANOVA|||||||0.77
74001144|NCT02909764|147550557|OTHER|General estimating equations (GEE)|||||<|0.05|||||||GEE|||Generalized estimating equations (GEE) were conducted on the amount of cereal in grams ingested during 28 days home-exposure period. The GEE approach accounts for the repeated measurements of outcomes over time for each child and examines whether the slopes of the lines created differ between the treatment groups.||||<0.05
74001145|NCT02909764|147550558|OTHER|T-tests were conducted to determine whether differences in baseline blood pressure between groups|||||>|0.4|||||||t-test, 2 sided|||T-tests were conducted to determine whether differences in baseline blood pressure between the two groups.||||>0.40
74001146|NCT00153062|147550566|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin of 1.075|Hazard Ratio (HR)|1.01||||0.783|TWO_SIDED|95.0|0.92|1.11|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs clopidogrel||1.11|0.92|0.7830
74001147|NCT00153062|147550567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8292|TWO_SIDED|95.0|0.92|1.07|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs Clopidogrel||1.07|0.92|0.8292
74001148|NCT00153062|147550568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.1073|TWO_SIDED|95.0|0.87|1.01|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates.||Telmisartan vs Placebo||1.01|0.87|0.1073
74001149|NCT00153062|147550569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.1007|TWO_SIDED|95.0|0.65|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline ACE-I use, and baseline modified Rankin score as covariates||Telmisartan vs Placebo||1.04|0.65|0.1007
74001150|NCT00153062|147550570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.2312|TWO_SIDED|95.0|0.86|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline Modified Rankin score as covariates||Telmisartan vs placebo||1.04|0.86|0.2312
74001151|NCT00275262|147550579|SUPERIORITY_OR_OTHER|||||||0.125|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.||||0.125
74001152|NCT00275262|147550580|SUPERIORITY_OR_OTHER|||||||0.299|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.||||0.299
74001153|NCT00189488|147550618|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-17.9||||0.034|TWO_SIDED|95.0|-33.4|-2.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Grade 2 to 4 acute GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||-2.4|-33.4|0.034
74001154|NCT00189488|147550619|SUPERIORITY_OR_OTHER||Adjusted Difference (%)|0.5||||0.929|TWO_SIDED|95.0|-11.0|12.1|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with severe GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||12.1|-11.0|0.929
74001155|NCT00189488|147550620|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-6.5||||0.352|TWO_SIDED|95.0|-19.4|6.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Day 11 Methotrexate GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||6.4|-19.4|0.352
74001156|NCT00189488|147550621|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-2.6||||0.675|TWO_SIDED|95.0|-14.2|9.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with severe oral mucositis, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|"Participants with Unknown incidence are treated as Yes when constructing the differences, 95% confidence intervals and p-value."||9.0|-14.2|0.675
74001157|NCT00189488|147550622|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.5||||0.953|TWO_SIDED|95.0|-1.5|2.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||2.5|-1.5|0.953
73877592|NCT00141102|147295031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.406|STANDARD_ERROR_OF_MEAN|2.624||0.592|TWO_SIDED|95.0|-6.55|3.74|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||3.74|-6.55|0.5920
74001158|NCT00189488|147550623|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|2.0||||0.797|TWO_SIDED|95.0|-12.5|16.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with opioid analgesic use, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||16.5|-12.5|0.797
74001159|NCT00189488|147550624|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-5.5||||0.186|TWO_SIDED|95.0|-12.7|1.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||1.8|-12.7|0.186
74001160|NCT00189488|147550625|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-4.1||||0.219|TWO_SIDED|5.0|-12.2|4.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||4.0|-12.2|0.219
74001161|NCT02349425|147550654|SUPERIORITY||Estimated percent change|-41.222||||0.0055|TWO_SIDED|95.0|-59.294|-15.127|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-15.127|-59.294|0.0055
74001162|NCT02349425|147550654|SUPERIORITY||Estimated percent change|-51.973||||0.0008|TWO_SIDED|95.0|-68.23|-27.397|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-27.397|-68.230|0.0008
74001163|NCT02349425|147550654|SUPERIORITY||Estimated percent change|-46.853||||0.0075|TWO_SIDED|95.0|-66.291|-16.206|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-16.206|-66.291|0.0075
73877593|NCT00141102|147295032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.038||0.6819|TWO_SIDED|95.0|-0.09|0.06|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.06|-0.09|0.6819
73877594|NCT03400475|147295035|SUPERIORITY||Mean Difference (Final Values)|-2.088||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
73877595|NCT03400475|147295036|SUPERIORITY||Mean Difference (Final Values)|3.59||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
73877596|NCT03400475|147295037|SUPERIORITY||Mean Difference (Final Values)|3.596||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
73877597|NCT03400475|147295038|SUPERIORITY||Mean Difference (Final Values)|-0.083||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
73877598|NCT03400475|147295039|SUPERIORITY||Mean Difference (Final Values)|0.581||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
74001164|NCT02349425|147550654|SUPERIORITY||Estimated percent change|-57.067||||0.0009|TWO_SIDED|95.0|-73.375|-30.771|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-30.771|-73.375|0.0009
73877599|NCT03400475|147295040|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
73877600|NCT03400475|147295041|SUPERIORITY||Mean Difference (Final Values)|-64.696||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
73877601|NCT03400475|147295042|SUPERIORITY||Mean Difference (Final Values)|111.03||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
73877602|NCT03400475|147295043|SUPERIORITY||Mean Difference (Final Values)|213.314||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
73877603|NCT03400475|147295044|SUPERIORITY||Mean Difference (Final Values)|37.356||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
73877604|NCT03400475|147295045|SUPERIORITY||Mean Difference (Final Values)|1.6537||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
73877605|NCT03400475|147295046|SUPERIORITY||Mean Difference (Final Values)|1.552||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
73877606|NCT03400475|147295047|SUPERIORITY|||||||0.071|||||||Fisher Exact|||||||0.071
73877607|NCT03400475|147295048|SUPERIORITY|||||||0.071|||||||Fisher Exact|||||||0.071
73877608|NCT03400475|147295049|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73877609|NCT03400475|147295050|SUPERIORITY|||||||0.062|||||||Fisher Exact|||||||0.062
73877610|NCT03400475|147295051|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
73877611|NCT03400475|147295052|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
73877612|NCT00932321|147295061|NON_INFERIORITY_OR_EQUIVALENCE|Primary hypothesis tested was the independence (lack of association) of mean number of IB days in Cycles 2-6 across treatment groups.||||||0.311|||||||Cochran-Mantel-Haenszel|Stratified by investigational site.||||||0.311
73877613|NCT02775916|147295063|SUPERIORITY||Mean Difference (Net)|-0.69|STANDARD_DEVIATION|1.332|||TWO_SIDED|95.0|-3.343|1.937||||||||1.937|-3.343|
73877614|NCT02775916|147295064|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|1.466|||TWO_SIDED|95.0|-2.52|3.55||||||||3.55|-2.52|
73877615|NCT02775916|147295065|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|3.119|||TWO_SIDED|95.0|-6.08|6.89||||||||6.89|-6.08|
73877616|NCT02775916|147295065|SUPERIORITY||Mean Difference (Net)|4.33|STANDARD_ERROR_OF_MEAN|4.615|||TWO_SIDED|95.0|-5.27|13.93||||||||13.93|-5.27|
73877617|NCT02775916|147295066|SUPERIORITY||Mean Difference (Net)|-6.55|STANDARD_ERROR_OF_MEAN|7.27|||TWO_SIDED|95.0|-21.76|8.66||||||||8.66|-21.76|
73877618|NCT02775916|147295067|SUPERIORITY||Mean Difference (Net)|-10.97|STANDARD_ERROR_OF_MEAN|9.626|||TWO_SIDED|95.0|-30.94|9.0||||||||9.00|-30.94|
73877619|NCT02775916|147295068|SUPERIORITY||Mean Difference (Net)|-7.69|STANDARD_ERROR_OF_MEAN|10.595|||TWO_SIDED|95.0|-29.75|14.37||||||||14.37|-29.75|
73877620|NCT03112681|147295087|SUPERIORITY|||||||0.0001|||||||paired t-test|||||||0.0001
73877621|NCT03112681|147295087|SUPERIORITY|||||||0.0002|||||||paired t-test|||||||0.0002
73877622|NCT03016312|147295108|SUPERIORITY||Hazard Ratio (HR)|1.184||||0.094|TWO_SIDED|95.0|0.971|1.445|||Log Rank|||Unstratified Analysis||1.445|0.971|0.0940
73877623|NCT03016312|147295108|SUPERIORITY||Hazard Ratio (HR)|1.118||||0.2786|TWO_SIDED|95.0|0.913|1.37|||Log Rank|||Stratified Analysis||1.370|0.913|0.2786
73877624|NCT03016312|147295109|SUPERIORITY||Difference in Event Free Rate|-0.2||||0.9391|TWO_SIDED|95.0|-5.38|4.97|||z-test|||Difference in Event Free Rate - 6 months||4.97|-5.38|0.9391
73877625|NCT03016312|147295109|SUPERIORITY||Difference in Event Free Rate|-4.03||||0.2706|TWO_SIDED|95.0|-11.21|3.14|||z-test|||Difference in Event Free Rate - 12 months||3.14|-11.21|0.2706
73877626|NCT03016312|147295111|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.3157|TWO_SIDED|95.0|0.775|1.086|||Log Rank|||Unstratified Analysis||1.086|0.775|0.3157
73877627|NCT03016312|147295111|SUPERIORITY||Hazard Ratio (HR)|0.899||||0.2366|TWO_SIDED|95.0|0.754|1.072|||Log Rank|||Stratified Analysis||1.072|0.754|0.2366
73877628|NCT03016312|147295112|SUPERIORITY||Difference in Event Free Rate|2.21||||0.5959|TWO_SIDED|95.0|-5.95|10.37|||z-test|||Difference in Event Free Rate - 6 months||10.37|-5.95|0.5959
74001165|NCT02349425|147550655|SUPERIORITY||Estimated percent change|-14.691||||0.2542|TWO_SIDED|95.0|-35.307|12.493|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||12.493|-35.307|0.2542
74001166|NCT02349425|147550655|SUPERIORITY||Estimated percent change|-25.165||||0.0267|TWO_SIDED|95.0|-42.014|-3.421|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-3.4210|-42.014|0.0267
73877629|NCT03016312|147295112|SUPERIORITY||Difference in Event Free Rate|1.44||||0.6262|TWO_SIDED|95.0|-4.35|7.23|||z-test|||Difference in Event Free Rate - 12 months||7.23|-4.35|0.6262
74001167|NCT02349425|147550655|SUPERIORITY||Estimated percent change|-37.146||||0.0198|TWO_SIDED|95.0|-57.345|-7.3821|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-7.3821|-57.345|0.0198
74001168|NCT02349425|147550655|SUPERIORITY||Estimated percent change|-55.92||||0.0006|TWO_SIDED|95.0|-71.923|-30.797|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-30.797|-71.923|0.0006
74001169|NCT02349425|147550660|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.003|TWO_SIDED|95.0|-31.2|-6.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.8|-31.2|0.003
74001170|NCT02349425|147550660|SUPERIORITY||Mean Difference (Final Values)|-24.4|||<|0.001|TWO_SIDED|95.0|-36.7|-12.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-12.1|-36.7|<0.001
74001171|NCT02349425|147550660|SUPERIORITY||Mean Difference (Final Values)|-29.3||||0.005|TWO_SIDED|95.0|-49.0|-9.5|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model.||||-9.5|-49.0|0.005
74001172|NCT02349425|147550660|SUPERIORITY||Mean Difference (Final Values)|-29.6|||<|0.001|TWO_SIDED|95.0|-44.6|-14.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-14.7|-44.6|<0.001
74001173|NCT02349425|147550661|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.332|TWO_SIDED|95.0|-21.0|7.2|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||7.2|-21.0|0.332
74001174|NCT02349425|147550661|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.008|TWO_SIDED|95.0|-23.3|-3.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-3.6|-23.3|0.008
74001175|NCT02349425|147550661|SUPERIORITY||Mean Difference (Final Values)|-30.2|||<|0.001|TWO_SIDED|95.0|-44.7|-15.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-15.7|-44.7|<0.001
74090798|NCT02408068|147735661|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|77.56|||||TWO_SIDED|90.0|70.89|84.86|||ANOVA|||Results obtained using a mixed effects ANOVA with fixed effects for study period, sequence, treatment and subject (sequence) (excl. tmax).||84.86|70.89|
74090799|NCT02408068|147735662|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|108.33|||||TWO_SIDED|90.0|102.3|114.72|||ANOVA|||||114.72|102.30|
73877630|NCT03016312|147295113|SUPERIORITY||Difference in 50% Decrease Response Rate|1.6|||||TWO_SIDED|2.0|-4.5|7.8|||||||Odds Ratio: 1.1 95%CI: 0.8, 1.5|7.8|-4.5|
74001176|NCT02349425|147550661|SUPERIORITY||Mean Difference (Final Values)|-26.7||||0.001|TWO_SIDED|95.0|-42.3|-11.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-11.0|-42.3|0.001
74001177|NCT02349425|147550662|SUPERIORITY||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-23.5|-6.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.8|-23.5|<0.001
74001178|NCT02349425|147550662|SUPERIORITY||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-26.1|-7.4|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-7.4|-26.1|<0.001
74001179|NCT02349425|147550662|SUPERIORITY||Mean Difference (Final Values)|-19.5||||0.002|TWO_SIDED|95.0|-31.1|-7.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-7.8|-31.1|0.002
74001180|NCT02349425|147550662|SUPERIORITY||Mean Difference (Final Values)|-20.5|||<|0.001|TWO_SIDED|95.0|-31.8|-9.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.3|-31.8|<0.001
74001181|NCT02349425|147550663|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.315|TWO_SIDED|95.0|-12.3|4.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||4.0|-12.3|0.315
74001182|NCT02349425|147550663|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.03|TWO_SIDED|95.0|-13.7|-0.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.7|-13.7|0.030
74001183|NCT02349425|147550663|SUPERIORITY||Mean Difference (Final Values)|-18.2|||<|0.001|TWO_SIDED|95.0|-27.4|-9.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.1|-27.4|<0.001
74001184|NCT02349425|147550663|SUPERIORITY||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|95.0|-26.3|-9.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.0|-26.3|<0.001
74001185|NCT02349425|147550664|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.169|TWO_SIDED|95.0|-8.6|1.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.6|-8.6|0.169
74001186|NCT02349425|147550664|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.341|TWO_SIDED|95.0|-7.5|2.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.6|-7.5|0.341
74001187|NCT02349425|147550664|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.311|TWO_SIDED|95.0|-5.8|1.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.9|-5.8|0.311
74001188|NCT02349425|147550664|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.128|TWO_SIDED|95.0|-8.6|1.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.1|-8.6|0.128
74001189|NCT02349425|147550665|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.613|TWO_SIDED|95.0|-3.5|5.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.9|-3.5|0.613
74090800|NCT02408068|147735663|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.25||||0.0005|TWO_SIDED|95.0|1.25|3.75|||Wilcoxon (Mann-Whitney)|||||3.75|1.25|0.0005
74090801|NCT02408068|147735664|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|83.27|||||TWO_SIDED|90.0|75.58|91.74||||||||91.74|75.58|
74001190|NCT02349425|147550665|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.743|TWO_SIDED|95.0|-4.3|3.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||3.1|-4.3|.743
74001191|NCT02349425|147550665|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.589|TWO_SIDED|95.0|-4.1|2.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.3|-4.1|0.589
74001192|NCT02349425|147550665|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.205|TWO_SIDED|95.0|-13.2|2.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.9|-13.2|0.205
74001193|NCT02349425|147550666|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0811|TWO_SIDED|95.0|-1.4|0.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||0.1|-1.4|0.0811
74001194|NCT02349425|147550666|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.0097|TWO_SIDED|95.0|-2.2|-0.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.3|-2.2|0.0097
74001195|NCT02349425|147550666|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.0025|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.6|-2.6|0.0025
74001196|NCT02349425|147550666|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.005|TWO_SIDED|95.0|-2.8|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-2.8|0.0050
74001197|NCT02349425|147550667|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.0506|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||0.0|-1.4|0.0506
74001198|NCT02349425|147550667|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0447|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.0|-1.7|0.0447
74001199|NCT02349425|147550667|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.0026|TWO_SIDED|95.0|-2.2|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-2.2|0.0026
74001200|NCT02349425|147550667|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0405|TWO_SIDED|95.0|-2.2|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.0|-2.2|0.0405
74090802|NCT02408068|147735665|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|118.83|||||TWO_SIDED|90.0|111.58|126.54||||||||126.54|111.58|
74090803|NCT02408068|147735666|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|3.5||||0.0014|TWO_SIDED|95.0|2.25|4.38|||Wilcoxon (Mann-Whitney)|||||4.38|2.25|0.0014
73877631|NCT03016312|147295114|SUPERIORITY||Hazard Ratio (HR)|1.055||||0.5359|TWO_SIDED|95.0|0.89|1.251|||Log Rank|||Unstratified Analysis||1.251|0.890|0.5359
73877632|NCT03016312|147295114|SUPERIORITY||Hazard Ratio (HR)|1.037||||0.6857|TWO_SIDED|95.0|0.869|1.238|||Log Rank|||Stratified Analysis||1.238|0.869|0.6857
74001201|NCT02349425|147550668|SUPERIORITY||Mean Difference (Final Values)|3.84|||<|0.001|TWO_SIDED|95.0|1.88|5.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.80|1.88|<0.001
74001202|NCT02349425|147550668|SUPERIORITY||Mean Difference (Final Values)|3.52|||<|0.001|TWO_SIDED|95.0|1.66|5.38|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.38|1.66|<0.001
74001203|NCT02349425|147550669|SUPERIORITY||Mean Difference (Final Values)|-10.6||||0.096|TWO_SIDED|95.0|-23.2|1.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.9|-23.2|0.096
74001204|NCT02349425|147550669|SUPERIORITY||Mean Difference (Final Values)|-20.0||||0.005|TWO_SIDED|95.0|-33.6|-6.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.3|-33.6|0.005
74001205|NCT02349425|147550669|SUPERIORITY||Mean Difference (Final Values)|-26.1|||<|0.001|TWO_SIDED|95.0|-40.7|-11.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-11.6|-40.7|<0.001
74001206|NCT02349425|147550669|SUPERIORITY||Mean Difference (Final Values)|-33.8|||<|0.001|TWO_SIDED|95.0|-48.4|-19.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-19.1|-48.4|<0.001
74001207|NCT02349425|147550670|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.311|TWO_SIDED|95.0|-19.1|6.2|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||6.2|-19.1|0.311
74001208|NCT02349425|147550670|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.232|TWO_SIDED|95.0|-19.7|4.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||4.9|-19.7|0.232
74001209|NCT02349425|147550670|SUPERIORITY||Mean Difference (Final Values)|-15.6||||0.012|TWO_SIDED|95.0|-27.6|-3.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-3.6|-27.6|0.012
74001210|NCT02349425|147550670|SUPERIORITY||Mean Difference (Final Values)|-15.4||||0.043|TWO_SIDED|95.0|-30.4|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-30.4|0.043
74008728|NCT01970488|147567521|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence was evaluated by comparing the 2-sided 95% confidence interval (CI) of the difference of PASI percent improvement from baseline to Week 16 between ABP 501 and adalimumab with an equivalence margin of ± 15.|Least Squares (LS) Mean Difference|-2.18|||||TWO_SIDED|95.0|-7.39|3.02||||||||3.02|-7.39|
74008729|NCT02092350|147567541|SUPERIORITY_OR_OTHER|||||||0.001|||||||One-sided exact test|||The primary hypothesis was that the SVR12 rate in the Immediate Treatment plus Intensive PK arm would be \>45%.||||0.001
74008730|NCT00239226|147567546|SUPERIORITY_OR_OTHER||Slope|3.93||||0.047|||||||Log Rank|||||||0.047
74008731|NCT00646906|147567562|SUPERIORITY|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA|||The primary hypothesis is that acetaminophen given two hours before aspirin will antagonize the effects of aspirin, while reversing the order of administration will not. Percent change from start (8:00 am on day 1) to finish (8:00 am on day 7) of period in serum thromboxane B2 for each order of drug administration will be primary endpoint of interest.||||>0.05
73877633|NCT00308139|147295125|NON_INFERIORITY_OR_EQUIVALENCE|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide LAR and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.107||0.0023|TWO_SIDED|95.0|-0.54|-0.12|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors.||Superiority of exenatide long-acting release (LAR) once weekly to BYETTA if the upper limit of the 2-sided 95% confidence interval (CI) for treatment difference (LAR minus BYETTA) is less than 0; non-inferiority if this upper limit is less than 0.4%. Power:Assuming 20% dropout rate with 246 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in LAR and a common standard deviation of 1.2%.||-0.12|-0.54|0.0023
73877634|NCT00308139|147295128|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of \<7% at Week 30 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.0003
74001211|NCT00645801|147550681|SUPERIORITY|||||||0.05||||||A 2-sided 2 sample t test was used to compare the overall cleanliness score between the 2 treatment groups.|t-test, 2 sided|||Based on the assumption that 70% of patients using PEG plus placebo (group 2) will have good results, by allocating 100 cases in each group, we will have 84% power to detect a difference of 18% or more in the effectiveness of PEG plus lubiprostone combination (group 1) (eg, 70% in group 2 vs. 88% in group 1) at the alpha level of significancelevel of significance.||||0.05
74001212|NCT00645801|147550682|SUPERIORITY||||||<|0.05|||||||2 sided Cochran-Armitage trend test|||||||<0.05
74001213|NCT00645801|147550683|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
74008732|NCT00646906|147567563|SUPERIORITY|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA|||||||>0.05
74008733|NCT01177384|147567580|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.62|||<|0.001|TWO_SIDED|95.0|-0.79|-0.44||The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline A1C.|ANCOVA|||||-0.44|-0.79|<.001
74008734|NCT01177384|147567581|SUPERIORITY_OR_OTHER||Difference in least squares mean|-14.4|||<|0.001|TWO_SIDED|95.0|-21.8|-7.0||The ANCOVA model included terms for treatment and prior AHA therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline FPG.|ANCOVA|||||-7.0|-21.8|<.001
74008735|NCT01849497|147567584|SUPERIORITY_OR_OTHER||Treatment Difference|-6.8|||||TWO_SIDED|95.0|-16.3|2.0||||||||2.0|-16.3|
74008736|NCT01849497|147567585|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-3.7|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-10.38|2.99||||||||2.99|-10.38|
74008737|NCT00307333|147567595|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
74008738|NCT00307333|147567596|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||||||0.47
74008739|NCT00307333|147567597|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||||||0.31
74008740|NCT00307333|147567598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.61|0.99|||||HR = hazard for intervention / hazard for control|||0.99|0.61|
74008741|NCT00698932|147567599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|-0.65|-0.34|||ANCOVA|\*adjusted for baseline HbA1c||||-0.34|-0.65|<0.0001
74008742|NCT00698932|147567600|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.06|-0.39|||ANCOVA|\*adjusted for baseline FPG||||-0.39|-1.06|<0.0001
74008743|NCT00698932|147567601|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.12|STANDARD_ERROR_OF_MEAN|3.053|<|0.0001||95.0|-19.12|-7.13|||ANCOVA|\*adjusted for baseline FPG||||-7.13|-19.12|<0.0001
74008744|NCT00698932|147567602|SUPERIORITY_OR_OTHER||Median Difference (Net)|-182.0|STANDARD_ERROR_OF_MEAN|54.4||0.001||95.0|-289.0|-74.0|||ANCOVA|\*adjusted for baseline PPG AUC||||-74|-289|0.001
74008745|NCT00698932|147567603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3280.0|STANDARD_ERROR_OF_MEAN|980.0||0.001||95.0|-5214.0|-1345.0|||ANCOVA|\*adjusted for baseline PPG AUC||||-1345|-5214|0.001
74008746|NCT00698932|147567604|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0|||<|0.0001||95.0|8.9|24.9|||ANCOVA|||||24.9|8.9|<0.0001
74008747|NCT03044249|147567612|SUPERIORITY||Response Ratio|4.0||||0.48|TWO_SIDED|90.0|-18.0|25.0|||Fisher Exact|||||25|-18|0.48
74008748|NCT03044249|147567614|SUPERIORITY||Mean Difference (Final Values)|-5.28||||0.14|TWO_SIDED|90.0|-11.16|0.61|||Mixed Models Analysis|||||0.61|-11.16|0.14
74008749|NCT03044249|147567615|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.37|TWO_SIDED|90.0|-4.47|1.31|||Mixed Models Analysis|||||1.31|-4.47|0.37
74008750|NCT03044249|147567619|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.94|TWO_SIDED|90.0|-2.0|1.84|||Mixed Models Analysis|||||1.84|-2.00|0.94
74008751|NCT00955279|147567621|SUPERIORITY_OR_OTHER|||||||0.543|||||||ANCOVA|||||||0.543
74008752|NCT00955279|147567621|SUPERIORITY_OR_OTHER|||||||0.126|||||||ANCOVA|||||||0.126
74008753|NCT00955279|147567622|SUPERIORITY_OR_OTHER|||||||0.896|||||||Linear Contrasts Test|||||||0.896
74008754|NCT00955279|147567622|SUPERIORITY_OR_OTHER|||||||0.063|||||||Linear Contrasts Test|||||||0.063
74008755|NCT00955279|147567623|SUPERIORITY_OR_OTHER|||||||0.374|||||||Linear Contrasts Test|||||||0.374
74008756|NCT00955279|147567623|SUPERIORITY_OR_OTHER|||||||0.073|||||||Linear Contrasts Test|||||||0.073
74008757|NCT00955279|147567624|SUPERIORITY_OR_OTHER|||||||0.1931|||||||Fisher Exact|||||||0.1931
74008758|NCT00955279|147567624|SUPERIORITY_OR_OTHER|||||||0.2772|||||||Fisher Exact|||||||0.2772
74008759|NCT00955279|147567625|SUPERIORITY_OR_OTHER|||||||0.451|||||||Linear Contrast Test|||||||0.451
74008760|NCT00955279|147567625|SUPERIORITY_OR_OTHER|||||||0.546|||||||Linear Contrast Test|||||||0.546
74001214|NCT00705679|147550687|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.37|TWO_SIDED|95.0|0.61|1.21||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||1.21|0.61|0.37
74001215|NCT00705679|147550690|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.49||||0.07|TWO_SIDED|95.0|0.97|2.29||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||2.29|0.97|0.07
74001216|NCT00705679|147550693|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.81|TWO_SIDED|95.0|0.73|1.49||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||1.49|0.73|0.81
74001217|NCT00705679|147550694|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||Fisher Exact|Two-sided Fisher's Exact Test.||||||0.004
74001218|NCT00118755|147550695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3883|TWO_SIDED|95.0|0.67|1.17|||Log Rank|||||1.17|0.67|0.3883
74001219|NCT00118755|147550696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2458|TWO_SIDED|95.0|0.64|1.12|||Log Rank|||||1.12|0.64|0.2458
74001220|NCT00118755|147550697|SUPERIORITY_OR_OTHER||Difference in Response Rate|9.8||||||95.0|0.9|18.7|||||95% Wald asymptotic CI using normal approximation (continuity corrected)|||18.7|0.9|
74001221|NCT00118755|147550698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.6294||95.0|0.66|1.97|||Log Rank|||||1.97|0.66|0.6294
74001222|NCT01143038|147550705|SUPERIORITY_OR_OTHER_LEGACY||Mean|9.2|||||TWO_SIDED|95.0|8.3|10.1|||||Based on the t-distribution|||10.1|8.3|
74001223|NCT01143038|147550705|SUPERIORITY_OR_OTHER_LEGACY||Bootstrap mean|9.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|8.3|10.0|||||Estimates are based on bootstrap method with 1000 samples with replacement.|Bootstrap analysis||10.0|8.3|
74001224|NCT01346475|147550712|SUPERIORITY_OR_OTHER||Incident Risk Ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.44|0.66|||Incident risk ratio|The model is adjusted for period effects.||This study had 80% power to detect a 50% reduction in HSV genital shedding rates for high-dose valacyclovir compared to standard dose valacyclovir.||0.66|0.44|<0.001
74036898|NCT00696436|147627104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.72|TWO_SIDED|95.0|-2.51|1.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.73|-2.51|0.720
74036899|NCT00696436|147627104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.62||||0.018|TWO_SIDED|95.0|-4.79|-0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.45|-4.79|0.018
74036900|NCT00696436|147627105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.64|||<|0.001|TWO_SIDED|95.0|-10.42|-6.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-6.87|-10.42|<0.001
74001225|NCT01171807|147550716|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74001226|NCT02874924|147550723|EQUIVALENCE|Pilot study, therefore, no power calculation available.|Mean Difference (Net)|-1.81||||0.56|TWO_SIDED|95.0|-8.48|4.86|||t-test, 2 sided|||Null hypothesis||4.86|-8.48|0.56
74036901|NCT00696436|147627105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|||<|0.001|TWO_SIDED|95.0|-9.52|-5.99||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.99|-9.52|<0.001
74036902|NCT00696436|147627105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.341|TWO_SIDED|95.0|-2.21|0.77||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.77|-2.21|0.341
74001227|NCT02469389|147550744|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at BL (any difference was assumed due to random sampling error).||||||0.295|||||||Mixed Models Analysis|Post-hoc mixed effects model analyses of all outcomes were performed adjusting for BL CAINS MAP score.||Analyses of the primary and secondary outcomes utilized a linear mixed effects model accounting for random therapy group effects and included all available data at baseline (BL), post-treatment (PT; 12-week), and follow-up (FU; 24-week) timepoints (TPs). Error terms across TPs were assumed correlated with unstructured correlation matrix. To test time specific hypotheses, terms in the mean model included separate indicators for PT \& FU \& interaction terms between these indicators and conditions.||||0.295
74001228|NCT02469389|147550745|SUPERIORITY|||||||0.182|||||||Mixed Models Analysis|||||||0.182
74001229|NCT02469389|147550746|SUPERIORITY|||||||0.114|||||||Mixed Models Analysis|||||||0.114
74001230|NCT02469389|147550747|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.220
74001231|NCT02469389|147550748|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
74001232|NCT02469389|147550749|SUPERIORITY|||||||0.903|||||||Mixed Models Analysis|||||||0.903
74001233|NCT02469389|147550750|SUPERIORITY|||||||0.535|||||||Mixed Models Analysis|||||||0.535
74036903|NCT00696436|147627105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28||||0.003|TWO_SIDED|95.0|-3.8|-0.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.76|-3.80|0.003
74036904|NCT00696436|147627105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.821|TWO_SIDED|95.0|-1.3|1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.64|-1.30|0.821
74001234|NCT02469389|147550751|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
74001235|NCT02469389|147550752|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||||||0.692
74001236|NCT02469389|147550753|SUPERIORITY|||||||0.498|||||||Mixed Models Analysis|||||||0.498
74001237|NCT02469389|147550754|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|||||||0.079
74001238|NCT02469389|147550755|SUPERIORITY|||||||0.539|||||||Mixed Models Analysis|||||||0.539
74090804|NCT03399318|147735676|SUPERIORITY||||||<|0.0001||||||treatment group as the factor of interest, country and disease severity 207 (CM=yes, no) as stratification factors, and admission temperature as a covariate. A t-test for significance of the treatment effect, were derived from this model.|t-test, 2 sided|||The analysis of the primary outcome variable, Tmax, involved fitting an analysis of 206 covariance model with treatment group as the factor of interest, country and disease severity 207 (CM=yes, no) as stratification factors, and admission temperature as a covariate. The estimated 208 treatment effect and associated 95% confidence interval, as well as a t-test for significance of the treatment effect, were derived from this model.||||<0.0001
74036905|NCT00696436|147627105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.071|TWO_SIDED|95.0|-2.89|0.12||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.12|-2.89|0.071
74036906|NCT00696436|147627106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.45|||<|0.001|TWO_SIDED|95.0|-17.96|-12.94||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-12.94|-17.96|<0.001
74090805|NCT03399318|147735677|SUPERIORITY||Odds Ratio (OR)|0.09|||<|0.05|TWO_SIDED|95.0|0.03|0.27|||Regression, Logistic|||Seizure occurrence defined as a three-level ordinal variable was analyzed using a 223 multinomial logistic regression model because there was evidence that the proportional odds 224 assumption did not hold. This model included treatment group as the factor of interest and 225 country and disease severity as stratification factors. The adjusted treatment group odds ratio, 226 and its associated 95% confidence interval were derived from this model.||.27|.03|<0.05
74090806|NCT03399318|147735678|SUPERIORITY||Odds Ratio, log|6.3|||<|0.05|TWO_SIDED|95.0|-5.1|17.7||The covariance matrix for the within-participant observations was 232 modeled using an unstructured pattern.|ANCOVA|Time to parasite clearance was 235 evaluated using a discrete-time proportional hazards model with a complementary log-log link.|The adjusted treatment group difference in mean area 233 under the log10(HRP2 level) × time curve was estimated using appropriate contrasts among the 234 treatment group means over time that quantify this comparison.|Parasite clearance measured by log10 (HRP2 level) was analyzed with a repeated 228 measures analysis of covariance model (mixed model repeated measures)35 with terms for 229 treatment group, country, disease severity, log10(HRP2 level) at admission, time (treated as a 230 categorical variable), and interaction terms for admission log10(HRP2 level) and time, and for 231 treatment group and time.|The model included terms for treatment group, country, and disease severity.|17.7|-5.1|<0.05
74090807|NCT03399318|147735679|SUPERIORITY||Odds Ratio (OR)|0.32|||<|0.05|TWO_SIDED|95.0|0.2|0.52||An ordinal logistic regression model assuming 216 proportional odds with terms for treatment group, country, and disease severity as covariates was used to derive the estimated adjusted treatment group odds ratio and 95%CI|Regression, Logistic|Sensitivity analyses with best-case and worst-case imputation were 219 performed to accommodate missing data||A secondary efficacy measure included fever exposure as measured by the area under 214 the temperature × time curve for T≥38.5°C during the 72-hour follow-up period, categorized as 215 0, \> 0 and \< 2, and ≥ 2 degree-hours.||.52|.20|<0.05
74090808|NCT03852459|147735686|SUPERIORITY|||||||0.4272|||||||ANCOVA|||||||0.4272
74090809|NCT03629028|147735692|NON_INFERIORITY|Data compared to meta-analysis conducted in Sardo et al., 2017||||||0.05|||||||Chi-squared|Chi-squared or Fisher's test statistic was used to compare the categorical variables.||The sample size was calculated based on the study of Sardo et al. The website http://powerandsamplesize.com/Calculators was used. As a result of the sample size calculation with 90% power and 0.05 alpha error, it was planned to include 141 patients in each group.||||0.05
74090810|NCT00856973|147735723|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|7.33|STANDARD_ERROR_OF_MEAN|3.91|>|0.05|TWO_SIDED|97.5|-5.17|19.83|||ANCOVA|Bonferroni adjustment was use for multiple comparisons|Difference calculated as Eszopiclone minus placebo|This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment grou||19.83|-5.17|>0.05
74090811|NCT00856973|147735723|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|2.21|STANDARD_ERROR_OF_MEAN|3.91|>|0.05|TWO_SIDED|97.5|-10.23|14.65|||ANCOVA|||This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment group.||14.65|-10.23|>0.05
74090812|NCT00912093|147735747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
74090813|NCT00912093|147735748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
74090814|NCT00912093|147735749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||Peto Peto Wilcoxon|||||||0.012
74036907|NCT00696436|147627106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|||<|0.001|TWO_SIDED|95.0|-16.42|-11.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-11.43|-16.42|<0.001
74036908|NCT00696436|147627106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.002|TWO_SIDED|95.0|-5.42|-1.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.22|-5.42|0.002
74036909|NCT00696436|147627106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.11|||<|0.001|TWO_SIDED|95.0|-7.26|-2.97||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-2.97|-7.26|<0.001
74090815|NCT00912093|147735750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
74090816|NCT00912093|147735751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
73877635|NCT00308139|147295130|SUPERIORITY_OR_OTHER|||||||0.2042|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target value of \<=6.5% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.2042
73877636|NCT00308139|147295132|SUPERIORITY_OR_OTHER|||||||0.1513|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of \<=6.0% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.1513
73877637|NCT00308139|147295134|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|30.08|STANDARD_ERROR_OF_MEAN|11.458||0.0124|TWO_SIDED|95.0|6.88|53.28|||ANCOVA|||Analysis: Change in 2h postprandial glucose from baseline (Day -3) to Week 14 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the 2h postprandial glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline 2h postprandial glucose.||53.28|6.88|0.0124
73877638|NCT00308139|147295136|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.612||0.8916|TWO_SIDED|95.0|-1.29|1.12|||ANCOVA|||Analysis: Change in body weight from baseline (Day -3) to Week 30 was analyzed using an analysis of covariance (ANCOVA) model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.||1.12|-1.29|0.8916
73877639|NCT00308139|147295138|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-24.4|-9.4|||ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.||-9.4|-24.4|<.0001
73877640|NCT00308139|147295142|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|3.04||0.0077|TWO_SIDED|95.0|-14.1|-2.2|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.||-2.2|-14.1|0.0077
74001239|NCT03038438|147550756|OTHER|Single arm study with a hypothesis test comparing to performance goal|Proportion|88.0|||<|0.0001|ONE_SIDED|97.5|82.5||||Fisher Exact|||"The primary effectiveness endpoint, primary patency at 12 months, was tested against a PG of 75%. The null and alternative hypotheses tested appear below:~H0: π ≤ PG vs. HA: π \> PG where π is the primary patency rate at 12 months in the study population and PG is the performance goal of 75%. The primary effectiveness objective will be met if the lower limit of the 97.5% one-sided confidence interval is above 75%."|||82.5|<0.0001
73877641|NCT00308139|147295144|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.74||0.5613|TWO_SIDED|95.0|-1.0|1.9|||ANCOVA|||Analysis: Change in HDL-C from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.||1.9|-1.0|0.5613
74001240|NCT03038438|147550757|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Proportion|2.0|||<|0.0001|ONE_SIDED|97.5||5.0|||Fisher Exact|||"The primary safety endpoint, major adverse events at 30 days post-procedure, was tested against a performance goal of 12.5%. The null and alternative hypotheses tested appear below:~H0: P ≥ PG vs. HA: P \< PG where P is the primary safety endpoint at 30 days in the study population and PG is the performance goal.~The primary safety objective will be met if the upper limit of the 97.5% one-sided confidence interval is below 12.5%."||5.0||<0.0001
74008761|NCT02632721|147567640|OTHER||Probability of DLT rate in [0.16, 0.33)|0.081|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
73877642|NCT00308139|147295147|SUPERIORITY_OR_OTHER||Geometic Least Squares Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.042||0.2915|TWO_SIDED|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day -3), expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.||1.04|0.87|0.2915
73877643|NCT05757648|147295160|SUPERIORITY|||||||0.005|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.005
73877644|NCT05757648|147295161|SUPERIORITY|||||||0.775|||||||Mixed Models Analysis|||||||0.775
73877645|NCT05757648|147295162|SUPERIORITY|||||||0.682|||||||Mixed Models Analysis|||||||0.682
74090817|NCT04397445|147735765|SUPERIORITY|||||||0.54||||||A 1-sided lower P value \<.05 was considered significant for ranitidine vs. placebo as the aim was to evaluate if ranitidine increased NDMA exposure. Comparisons were performed separately with each diet without adjustment for multiplicity.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between ranitidine and placebo is 0 (-6.9 to 0) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.54
74090818|NCT04397445|147735765|SUPERIORITY|||||||0.71||||||A 1-sided lower P value \<.05 was considered significant for ranitidine vs. placebo as the aim was to evaluate if ranitidine increased NDMA exposure. Comparisons were performed separately with each diet without adjustment for multiplicity.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between ranitidine and placebo is -1.1 (-9.1 to 11.5) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.71
74090819|NCT04397445|147735766|SUPERIORITY|||||||0.005||||||Exploratory analyses on the effect of diet used a 1-sided lower P value \<.05 for NDMA as the cured-meats diet was designed to have higher NDMA.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between the cured-meats diet and noncured-meats diet is 9.3 (3.8 to 25.0) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.005
74090820|NCT04397445|147735766|SUPERIORITY|||||||0.007||||||Exploratory analyses on the effect of diet used a 1-sided lower P value \<.05 for NDMA as the cured-meats diet was designed to have higher NDMA|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between the cured-meats diet and noncured-meats diet is 6.4 (0 to 23.4) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.007
74036910|NCT00696436|147627106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.091|TWO_SIDED|95.0|-3.88|0.29||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.29|-3.88|0.091
74036911|NCT00696436|147627106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.59|||<|0.001|TWO_SIDED|95.0|-5.72|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.46|-5.72|<0.001
74036912|NCT00696436|147627107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.14|||<|0.001|TWO_SIDED|95.0|-11.92|-8.36||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-8.36|-11.92|<0.001
74090821|NCT04397445|147735767|OTHER||Geometric Mean Ratio|0.94||||0.92|TWO_SIDED|90.0|0.87|1.01||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator).|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.01|0.87|0.92
74036913|NCT00696436|147627107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.17|||<|0.001|TWO_SIDED|95.0|-10.94|-7.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.40|-10.94|<0.001
74036914|NCT00696436|147627107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.002|TWO_SIDED|95.0|-3.81|-0.82||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.82|-3.81|0.002
74036915|NCT00696436|147627107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71|||<|0.001|TWO_SIDED|95.0|-4.24|-1.19||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.19|-4.24|<0.001
74036916|NCT00696436|147627107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.076|TWO_SIDED|95.0|-2.82|0.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.14|-2.82|0.076
74036917|NCT00696436|147627107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74||||0.024|TWO_SIDED|95.0|-3.25|-0.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.22|-3.25|0.024
74001241|NCT00577473|147550785|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0455||||0.4411|TWO_SIDED|95.0|-7.01|16.11||4.8 g/day compared to 2.4 g/day|Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||16.11|-7.01|0.4411
74036918|NCT00696436|147627108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.84|||<|0.001|TWO_SIDED|95.0|-15.66|-10.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-10.02|-15.66|<0.001
74036919|NCT00696436|147627108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.91|||<|0.001|TWO_SIDED|95.0|-14.72|-9.11||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-9.11|-14.72|<0.001
74036920|NCT00696436|147627108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74||||0.149|TWO_SIDED|95.0|-4.1|0.62||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.62|-4.10|0.149
74036921|NCT00696436|147627108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.24|||<|0.001|TWO_SIDED|95.0|-6.65|-1.83||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.83|-6.65|<0.001
74001242|NCT00577473|147550786|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0331||||0.5677|TWO_SIDED|95.0|-14.67|8.04|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||8.04|-14.67|0.5677
74001243|NCT00577473|147550787|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0445||||0.473|TWO_SIDED|95.0|-16.6|7.7|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||7.7|-16.6|0.4730
74036922|NCT00696436|147627108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.494|TWO_SIDED|95.0|-3.16|1.53||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.53|-3.16|0.494
74036923|NCT00696436|147627108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.007|TWO_SIDED|95.0|-5.72|-0.93||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.93|-5.72|0.007
74036924|NCT00696436|147627109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|||<|0.001|TWO_SIDED|95.0|-10.03|-5.79||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.79|-10.03|<0.001
74036925|NCT00696436|147627109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.99|||<|0.001|TWO_SIDED|95.0|-10.1|-5.88||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.88|-10.10|<0.001
74036926|NCT00696436|147627109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.691|TWO_SIDED|95.0|-2.14|1.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.42|-2.14|0.691
74036927|NCT00696436|147627109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.39||||0.01|TWO_SIDED|95.0|-4.2|-0.57||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.57|-4.20|0.010
74036928|NCT00696436|147627109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.625|TWO_SIDED|95.0|-2.2|1.32||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.32|-2.20|0.625
74036929|NCT00696436|147627109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.46||||0.008|TWO_SIDED|95.0|-4.27|-0.66||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.66|-4.27|0.008
74001244|NCT00577473|147550788|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0339||||0.5761|TWO_SIDED|95.0|-8.48|15.26|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||15.26|-8.48|0.5761
73877646|NCT00101686|147295201|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.433||||0.0152||95.0|1.09|1.89||p-value corresponds to the log-rank test for comparing Kaplan-Meier survival curves.|Log Rank||Hazard ratio \[mIRI:FOLFIRI\] is from the Cox Proportional Hazard Model using treatment (FOLFIRI, mIRI, CapeIRI), age (\<=70 vs \>70), performance status (0 vs 1), aspirin (Yes vs No), celecoxib (Yes or No) as the covariates.|||1.89|1.09|0.0152
73877647|NCT00101686|147295202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.512||||0.0042||95.0|1.16|1.97|||Log Rank|||||1.97|1.16|0.0042
74001245|NCT00577473|147550789|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0766||||0.215|TWO_SIDED|95.0|-4.41|19.74|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||19.74|-4.41|0.2150
74001246|NCT00577473|147550790|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0351||||0.5569|TWO_SIDED|95.0|-8.18|15.2|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||15.20|-8.18|0.5569
74001247|NCT00577473|147550791|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1091||||0.0769|TWO_SIDED|95.0|-1.1|22.91|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||22.91|-1.10|0.0769
74001248|NCT00577473|147550792|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1139||||0.0551|TWO_SIDED|95.0|-0.13|22.92|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||22.92|-0.13|0.0551
74001249|NCT00577473|147550793|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0738||||0.2306|TWO_SIDED|95.0|-4.66|19.43|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||19.43|-4.66|0.2306
74001250|NCT00577473|147550794|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0652||||0.2931|TWO_SIDED|95.0|-5.6|18.64|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||18.64|-5.60|0.2931
74001251|NCT00577473|147550795|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0051||||0.9349|TWO_SIDED|95.0|-11.67|12.69|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||12.69|-11.67|0.9349
73877648|NCT00101686|147295202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.368||||0.0156||95.0|1.04|1.8|||Log Rank|||||1.80|1.04|0.0156
73877649|NCT00101686|147295202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.4659||95.0|0.81|1.38|||Log Rank|||||1.38|0.81|0.4659
73877650|NCT00101686|147295203|SUPERIORITY_OR_OTHER||F-distribution method|47.2||||||95.0|38.85|55.71|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||55.71|38.85|
73877651|NCT00101686|147295203|SUPERIORITY_OR_OTHER||F-distribution method|43.3||||||95.0|34.95|51.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||51.86|34.95|
73877652|NCT00101686|147295203|SUPERIORITY_OR_OTHER||F-distribution method|38.6||||||95.0|30.66|47.06|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||47.06|30.66|
73877653|NCT00101686|147295203|SUPERIORITY_OR_OTHER|||||||0.4751|||||||Cochran-Mantel-Haenszel|||||||0.4751
73877654|NCT00101686|147295203|SUPERIORITY_OR_OTHER|||||||0.1591|||||||Cochran-Mantel-Haenszel|||||||0.1591
73877655|NCT00101686|147295203|SUPERIORITY_OR_OTHER|||||||0.4395|||||||Cochran-Mantel-Haenszel|||||||0.4395
73877656|NCT00101686|147295204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.268||||0.0879||95.0|0.96|1.68|||Log Rank|||||1.68|0.96|0.0879
73877657|NCT00101686|147295204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2765||95.0|0.9|1.58|||Log Rank|||||1.58|0.90|0.2765
73877658|NCT00101686|147295204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.049||||0.9364||95.0|0.8|1.38|||Log Rank|||||1.38|0.80|0.9364
73877659|NCT00101686|147295206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.068||||0.7163||95.0|0.86|1.33|||Log Rank|||||1.33|0.86|0.7163
73877660|NCT00101686|147295207|SUPERIORITY_OR_OTHER||F-distribution method|39.4||||||95.0|32.83|46.34|||||confidence interval for binomial proportion using the F-distribution method (unit: %)|||46.34|32.83|
74090822|NCT04397445|147735767|OTHER||Geometric Mean Ratio|0.95||||0.74|TWO_SIDED|90.0|0.81|1.1||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator).|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.10|0.81|0.74
74001252|NCT00577473|147550796|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.065||||0.2583|TWO_SIDED|95.0|-4.72|17.73|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||17.73|-4.72|0.2583
74090823|NCT04397445|147735767|OTHER||Geometric Mean Ratio|1.05||||0.52|TWO_SIDED|95.0|0.9|1.23||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||1.23|0.90|0.52
74090824|NCT04397445|147735767|OTHER||Geometric Mean Ratio|1.05||||0.42|TWO_SIDED|95.0|0.93|1.19||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||1.19|0.93|0.42
74090825|NCT04397445|147735768|OTHER||Geometric Mean Ratio|0.81||||0.001|TWO_SIDED|95.0|0.72|0.91||Exploratory analyses on the effect of diet used a 2-sided P value \<.05 for ranitidine as the diet was not expected to affect these outcomes|Mixed Models Analysis|||As ranitidine data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|0.91|0.72|0.001
74036930|NCT00696436|147627110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.98|||<|0.001|TWO_SIDED|95.0|3.15|7.88||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.88|3.15|<0.001
74036931|NCT00696436|147627110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.66|||<|0.001|TWO_SIDED|95.0|2.94|7.37||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.37|2.94|<0.001
73877661|NCT00101686|147295207|SUPERIORITY_OR_OTHER||F-distribution method|46.5||||||95.0|39.76|53.42|||||confidence interval for binomial proportion using the F-distribution method (unit: %)|||53.42|39.76|
74036932|NCT00696436|147627110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.032|TWO_SIDED|95.0|1.03|2.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.03|1.03|0.032
74090826|NCT04397445|147735770|OTHER||Geometric Mean Ratio|1.0||||0.46|TWO_SIDED|90.0|0.91|1.11||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.11|0.91|0.46
74090827|NCT04397445|147735770|OTHER||Geometric Mean Ratio|1.0||||0.49|TWO_SIDED|90.0|0.8|1.25||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis|||As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from ranitidine (numerator) with placebo (denominator)|1.25|0.80|0.49
74090828|NCT04397445|147735770|OTHER||Geometric Mean Ratio|0.8||||0.02|TWO_SIDED|95.0|0.67|0.95||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||0.95|0.67|0.02
74090829|NCT04397445|147735770|OTHER||Geometric Mean Ratio|0.8||||0.03|TWO_SIDED|95.0|0.65|0.98||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis|||As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|0.98|0.65|0.03
73877662|NCT00101686|147295207|SUPERIORITY_OR_OTHER|||||||0.1559|||||||Cochran-Mantel-Haenszel|||||||0.1559
73877663|NCT00101686|147295208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.5316||95.0|0.86|1.36|||Log Rank|||||1.36|0.86|0.5316
73877664|NCT00101686|147295209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.269||||0.2835||95.0|0.75|2.15|||Log Rank|||||2.15|0.75|0.2835
73877665|NCT00101686|147295210|SUPERIORITY_OR_OTHER||F-distribution method|57.9||||||95.0|44.08|70.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||70.86|44.08|
74001253|NCT02884908|147550797|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.8|||||||Mixed Models Analysis|||||||0.80
74001254|NCT02884908|147550798|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.9|||||||Mixed Models Analysis|||||||0.90
74001255|NCT02884908|147550799|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.38|||||||Mixed Models Analysis|||||||0.38
74001256|NCT00986973|147550823|SUPERIORITY_OR_OTHER||||||>|0.05|ONE_SIDED||||||t-test, 2 sided|||||||>0.05
74001257|NCT00986973|147550824|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.82
74001258|NCT00986973|147550825|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.46
73877666|NCT00101686|147295210|SUPERIORITY_OR_OTHER||F-distribution method|53.3||||||95.0|40.0|66.33|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||66.33|40.00|
74001259|NCT00986973|147550826|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.071
74001260|NCT00986973|147550827|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.25
74001261|NCT00986973|147550828|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.050
74001262|NCT00986973|147550829|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.34
74001263|NCT02891408|147550909|OTHER||Geometric least-square mean (GLSM) ratio|181.0|||||TWO_SIDED|90.0|98.0|332.0||||||AUClast of Firsocostat||332|98|
74001264|NCT02891408|147550909|OTHER||GLSM ratio|881.0|||||TWO_SIDED|90.0|488.0|1589.0||||||AUClast of Firsocostat||1589|488|
74001265|NCT02891408|147550909|OTHER||GLSM ratio|3081.0|||||TWO_SIDED|90.0|2446.0|3881.0||||||AUClast of Firsocostat||3881|2446|
73877667|NCT00101686|147295210|SUPERIORITY_OR_OTHER|||||||0.7388|||||||Cochran-Mantel-Haenszel|||||||0.7388
73877668|NCT00101686|147295212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.794||||0.037||95.0|1.12|2.88|||Log Rank|||||2.88|1.12|0.0370
73877669|NCT00867165|147295222|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-26.74|||<|0.001|TWO_SIDED|95.0|-30.8|-22.69|||ANCOVA|||||-22.69|-30.80|<0.001
74001266|NCT02891408|147550909|OTHER||GLSM ratio|430.0|||||TWO_SIDED|90.0|185.0|998.0||||||AUClast of GS-834773||998|185|
74001267|NCT02891408|147550909|OTHER||GLSM ratio|4417.0|||||TWO_SIDED|90.0|1867.0|10449.0||||||AUClast of GS-834773||10449|1867|
74001268|NCT02891408|147550909|OTHER||GLSM ratio|14676.0|||||TWO_SIDED|90.0|7932.0|27153.0||||||AUClast of GS-834773||27153|7932|
74001269|NCT02891408|147550909|OTHER||GLSM ratio|122.0|||||TWO_SIDED|90.0|86.0|173.0||||||AUClast of Fenofibric Acid||173|86|
74001270|NCT02891408|147550910|OTHER||GLSM ratio|183.0|||||TWO_SIDED|90.0|100.0|337.0||||||AUCinf of Firsocostat||337|100|
74001271|NCT02891408|147550910|OTHER||GLSM ratio|869.0|||||TWO_SIDED|90.0|482.0|1568.0||||||AUCinf of Firsocostat||1568|482|
74001272|NCT02891408|147550910|OTHER||GLSM ratio|2976.0|||||TWO_SIDED|90.0|2389.0|3708.0||||||AUCinf of Firsocostat||3708|2389|
74001273|NCT02891408|147550910|OTHER||GLSM ratio|399.0|||||TWO_SIDED|90.0|179.0|892.0||||||AUCinf of GS-834773||892|179|
74001274|NCT02891408|147550910|OTHER||GLSM ratio|3843.0|||||TWO_SIDED|90.0|1641.0|9000.0||||||AUCinf of GS-834773||9000|1641|
74001275|NCT02891408|147550910|OTHER||GLSM ratio|10712.0|||||TWO_SIDED|90.0|6525.0|17585.0||||||AUCinf of GS-834773||17585|6525|
74001276|NCT02891408|147550910|OTHER||GLSM ratio|125.0|||||TWO_SIDED|90.0|89.0|174.0||||||AUCinf of Fenofibric Acid||174|89|
74001277|NCT02891408|147550911|OTHER||GLSM ratio|169.0|||||TWO_SIDED|90.0|87.0|326.0||||||Cmax of Firsocostat||326|87|
74001278|NCT02891408|147550911|OTHER||GLSM ratio|905.0|||||TWO_SIDED|90.0|537.0|1526.0||||||Cmax of Firsocostat||1526|537|
74001279|NCT02891408|147550911|OTHER||GLSM ratio|2719.0|||||TWO_SIDED|90.0|1994.0|3708.0||||||Cmax of Firsocostat||3708|1994|
74001280|NCT02891408|147550911|OTHER||GLSM ratio|391.0|||||TWO_SIDED|90.0|163.0|942.0||||||Cmax of GS-834773||942|163|
74001281|NCT02891408|147550911|OTHER||GLSM ratio|4470.0|||||TWO_SIDED|90.0|2170.0|9207.0||||||Cmax of GS-834773||9207|2170|
74001282|NCT02891408|147550911|OTHER||GLSM ratio|9278.0|||||TWO_SIDED|90.0|4945.0|17407.0||||||Cmax of GS-834773||17407|4945|
74001283|NCT02891408|147550911|OTHER||GLSM ratio|109.0|||||TWO_SIDED|90.0|81.0|146.0||||||Cmax of Fenofibric Acid||146|81|
74001284|NCT00709852|147550946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|0.61|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
74001285|NCT00709852|147550946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_DEVIATION|0.66|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
74001286|NCT00709852|147550946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|0.47|<|0.0001||||||for internal morphology|paired t-test|||||||< 0.0001
74001287|NCT00709852|147550947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|STANDARD_DEVIATION|0.77|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001288|NCT00709852|147550947|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.72|STANDARD_DEVIATION|0.78|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001289|NCT00709852|147550947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_DEVIATION|0.61|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001290|NCT00709852|147550948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|STANDARD_DEVIATION|0.51|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001291|NCT00709852|147550948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_DEVIATION|0.5|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001292|NCT00709852|147550948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_DEVIATION|0.52|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001293|NCT00709852|147550949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|STANDARD_DEVIATION|0.56|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001294|NCT00709852|147550949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|0.53|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001295|NCT00709852|147550949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_DEVIATION|0.42|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74036933|NCT00696436|147627110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.029|TWO_SIDED|95.0|1.04|2.06||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.06|1.04|0.029
73877670|NCT00867165|147295223|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.92|||<|0.001|TWO_SIDED|95.0|-24.2|-17.65|||ANCOVA|||||-17.65|-24.20|<0.001
74001296|NCT00709852|147550950|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|5.51|||TWO_SIDED|95.0|-0.199|0.984|||confidence interval for paired means|lower limit of interval is compared to noninferiority margin||BR 1||0.984|-0.199|
74001297|NCT00709852|147550950|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.44|STANDARD_DEVIATION|12.38|||TWO_SIDED|95.0|-1.772|0.885|||confidence interval for paired means|lower limit of confidence interval (CI) is compared to noninferiority margin||BR 2||0.885|-1.772|
74001298|NCT00709852|147550950|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|4.07|||TWO_SIDED|95.0|0.125|1.0|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||BR 3||1.000|0.125|
74001299|NCT00709852|147550950|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|5.68|||TWO_SIDED|95.0|-0.439|0.78|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||AR||0.780|-0.439|
74001300|NCT00709852|147550951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62|STANDARD_DEVIATION|0.3|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001301|NCT00709852|147550951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|0.37|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001302|NCT00709852|147550951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.38|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001303|NCT00709852|147550952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|STANDARD_DEVIATION|0.62|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001304|NCT00709852|147550952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_DEVIATION|0.46|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001305|NCT00709852|147550952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|0.39|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001306|NCT00709852|147550953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_DEVIATION|0.33|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001307|NCT00709852|147550953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.33|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
73877671|NCT00867165|147295224|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.24|||<|0.001|TWO_SIDED|95.0|-24.02|-16.45|||ANCOVA|||||-16.45|-24.02|<0.001
74001308|NCT00709852|147550953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_DEVIATION|0.32|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001309|NCT00709852|147550954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|0.3|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001310|NCT00709852|147550954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.23|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001311|NCT00709852|147550954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.22|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001312|NCT00709852|147550955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83|STANDARD_DEVIATION|1.16|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001313|NCT00709852|147550955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_DEVIATION|1.26|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001314|NCT00709852|147550955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|0.82|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
73877672|NCT00867165|147295225|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.807|TWO_SIDED|95.0|-4.97|6.36|||ANCOVA|||||6.36|-4.97|0.807
73877673|NCT00867165|147295226|SUPERIORITY_OR_OTHER_LEGACY||Differrence in least-squares means|-25.75|||<|0.001|TWO_SIDED|95.0|-29.59|-21.91|||ANCOVA|||||-21.91|-29.59|<0.001
73877674|NCT00867165|147295227|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-14.68||||0.021|TWO_SIDED|95.0|-27.35|-2.0|||Constrained longitudinal data analysis|||||-2.00|-27.35|0.021
74001315|NCT00709852|147550956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_DEVIATION|1.29|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001316|NCT00709852|147550956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|STANDARD_DEVIATION|1.44|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001317|NCT00709852|147550956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_DEVIATION|1.11|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001318|NCT00709852|147550957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_DEVIATION|0.95|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001319|NCT00709852|147550957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_DEVIATION|0.97|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001320|NCT00709852|147550957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|0.96|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001321|NCT00709852|147550958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|1.06|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001322|NCT00709852|147550958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|1.07|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001323|NCT00709852|147550958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_DEVIATION|0.83|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001324|NCT00709852|147550959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|STANDARD_DEVIATION|0.53|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
74001325|NCT00709852|147550959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.48|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001326|NCT00709852|147550959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_DEVIATION|0.41|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001327|NCT00709852|147550960|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|6.44|||TWO_SIDED|95.0|-0.532|0.851|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.851|-0.532|
74036934|NCT00696436|147627110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|95.0|0.96|1.89||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.89|0.96|0.080
74036935|NCT00696436|147627110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.071|TWO_SIDED|95.0|0.97|1.92||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.92|0.97|0.071
74036936|NCT00696436|147627111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29|||<|0.001|TWO_SIDED|95.0|2.1|5.15||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||5.15|2.10|<0.001
74036937|NCT00696436|147627111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|1.86|4.54||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||4.54|1.86|<0.001
74036938|NCT00696436|147627111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.306|TWO_SIDED|95.0|0.83|1.8||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.80|0.83|0.306
74036939|NCT00696436|147627111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.132|TWO_SIDED|95.0|0.92|1.97||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.97|0.92|0.132
74090830|NCT04397445|147735771|OTHER||Geometric Mean Ratio|0.77||||0.002|TWO_SIDED|95.0|0.66|0.89||Exploratory analyses on the effect of diet used a 2-sided P value \<.05 for ranitidine as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator).|As ranitidine data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||0.89|0.66|0.002
74001328|NCT00709852|147550961|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.33||||95.0|0.0004|0.078|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.078|0.0004|
74001329|NCT00709852|147550961|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.41||||95.0|-0.009|0.082|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.082|-0.009|
74001330|NCT00709852|147550961|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.29||||95.0|-0.006|0.059|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.059|-0.006|
74001331|NCT00709852|147550962|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|5.7||||95.0|-0.601|0.622|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.622|-0.601|
74001332|NCT00709852|147550963|SUPERIORITY_OR_OTHER||Difference in percentages|8.3|||||||||||||for BR1|||||
74090831|NCT00354341|147735793|SUPERIORITY_OR_OTHER|||||||0.8811|TWO_SIDED|||||P-value was calculated by ANCOVA with last observation carry forward (LOCF) method.|ANCOVA with LOCF|||||||0.8811
74001333|NCT00709852|147550963|SUPERIORITY_OR_OTHER||Difference in percentages|-0.9|||||||||||||for BR2|||||
74001334|NCT00709852|147550963|SUPERIORITY_OR_OTHER||Difference in percentages|15.8|||||||||||||for BR3|||||
74001335|NCT00709852|147550963|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|8.9|||||TWO_SIDED|95.0|-0.5|18.4|||CI for paired percentages|confidence interval is given for AR; lower limit is compared to the noninferiority margin||||18.4|-0.5|
74001336|NCT00709852|147550964|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|3.6||||||95.0|-5.9|13.1|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||13.1|-5.9|
74001337|NCT00709852|147550965|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|8.3||||||95.0|-0.9|17.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||17.6|-0.9|
74001338|NCT00709852|147550966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|0.78|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001339|NCT00709852|147550966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_DEVIATION|0.61|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74036940|NCT00696436|147627111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.695|TWO_SIDED|95.0|0.74|1.58||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.58|0.74|0.695
74036941|NCT00696436|147627111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.381|TWO_SIDED|95.0|0.81|1.74||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.74|0.81|0.381
74001340|NCT00709852|147550967|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|3.21||||95.0|-0.053|0.636|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.636|-0.053|
74001341|NCT00709852|147550968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.64|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001342|NCT00709852|147550968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_DEVIATION|0.5|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001343|NCT00709852|147550969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|1.26|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001344|NCT00709852|147550969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.97|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001345|NCT00709852|147550970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_DEVIATION|0.76|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001346|NCT00709852|147550970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_DEVIATION|0.63|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001347|NCT00709852|147550971|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|3.39||||95.0|-0.087|0.641|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.641|-0.087|
74036942|NCT00696436|147627112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.18|||<|0.001|TWO_SIDED|95.0|3.2|8.41||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||8.41|3.20|<0.001
74036943|NCT00696436|147627112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.43|||<|0.001|TWO_SIDED|95.0|2.73|7.19||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.19|2.73|<0.001
74036944|NCT00696436|147627112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.056|TWO_SIDED|95.0|0.99|1.94||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.94|0.99|0.056
74036945|NCT00696436|147627112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.036|TWO_SIDED|95.0|1.02|2.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.02|1.02|0.036
74036946|NCT00696436|147627112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.317|TWO_SIDED|95.0|0.85|1.66||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.66|0.85|0.317
74036947|NCT00696436|147627112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.234|TWO_SIDED|95.0|0.87|1.73||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.73|0.87|0.234
74036948|NCT02924688|147627125|SUPERIORITY||Least Squares Mean Difference|0.096|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.052|0.139||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study inhaled corticosteroids (ICS) dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.139|0.052|<0.001
74036949|NCT02924688|147627125|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.0221|<|0.001|TWO_SIDED|95.0|0.066|0.153||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.153|0.066|<0.001
74036950|NCT02924688|147627125|SUPERIORITY||Least Squares Mean Difference|0.082|STANDARD_ERROR_OF_MEAN|0.0221|<|0.001|TWO_SIDED|95.0|0.039|0.125||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.125|0.039|<0.001
74036951|NCT02924688|147627125|SUPERIORITY||Least Squares Mean Difference|0.092|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|95.0|0.049|0.135||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.135|0.049|<0.001
74090832|NCT00354341|147735794|SUPERIORITY_OR_OTHER|||||||0.8864|TWO_SIDED||||||ANCOVA with LOCF|||||||0.8864
74090833|NCT00354341|147735795|SUPERIORITY_OR_OTHER|||||||0.5681|TWO_SIDED||||||ANCOVA with LOCF|||||||0.5681
74090834|NCT00354341|147735796|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED||||||ANCOVA with LOCF|||||||0.1578
74090835|NCT00354341|147735797|SUPERIORITY_OR_OTHER|||||||0.2913|TWO_SIDED||||||ANCOVA with LOCF|||||||0.2913
74001348|NCT00709852|147550972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|0.61|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001349|NCT00709852|147550972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_DEVIATION|0.49|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001350|NCT00709852|147550973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|1.27|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
74001351|NCT00709852|147550973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|STANDARD_DEVIATION|1.01|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
74001352|NCT00709852|147550974|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.06||||||95.0|0.03|0.096|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.096|0.030|
74090836|NCT00354341|147735798|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
73877675|NCT00867165|147295228|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.97|||<|0.001|TWO_SIDED|95.0|-28.95|-20.99|||ANCOVA|||||-20.99|-28.95|<0.001
73877676|NCT00867165|147295229|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-23.94|||<|0.001|TWO_SIDED|95.0|-27.49|-20.39|||ANCOVA|||||-20.39|-27.49|<0.001
73877677|NCT00867165|147295230|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-27.71|||<|0.001|TWO_SIDED|95.0|-31.7|-23.73|||ANCOVA|||||-23.73|-31.70|<0.001
73877678|NCT00867165|147295231|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.09|||<|0.001|TWO_SIDED|95.0|-23.3|-16.89|||ANCOVA|||||-16.89|-23.30|<0.001
74001353|NCT00709852|147550974|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04||||||95.0|0.003|0.071|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.071|0.003|
74001354|NCT00709852|147550974|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|0.003|0.055|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.055|0.003|
74001355|NCT00709852|147550975|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.59||||95.0|-0.049|0.078|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.078|-0.049|
74036952|NCT02924688|147627126|SUPERIORITY||Rate Ratio|0.97||||0.778|TWO_SIDED|95.0|0.81|1.17||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, \>=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.|||1.17|0.81|0.778
73877679|NCT00867165|147295232|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.27|||<|0.001|TWO_SIDED|95.0|-23.39|-17.15|||ANCOVA|||||-17.15|-23.39|<0.001
74001356|NCT00709852|147550976|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|-0.009|0.065|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.065|-0.009|
74036953|NCT02924688|147627126|SUPERIORITY||Rate Ratio|0.87||||0.151|TWO_SIDED|95.0|0.72|1.05||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, \>=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.|||1.05|0.72|0.151
74091722|NCT05472662|147737052|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.69||||0.294|TWO_SIDED|95.0|-2.01|0.64|||ANCOVA|||"Statistical analysis performed on the data at 3 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||0.64|-2.01|0.294
73877680|NCT00867165|147295233|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-21.37|||<|0.001|TWO_SIDED|95.0|-24.67|-18.08|||ANCOVA|||||-18.08|-24.67|<0.001
73877681|NCT00867165|147295234|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-0.95||||0.733|TWO_SIDED|95.0|-6.46|4.55|||ANCOVA|||||4.55|-6.46|0.733
73877682|NCT00867165|147295235|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.53||||0.863|TWO_SIDED|95.0|-5.59|6.66|||ANCOVA|||||6.66|-5.59|0.863
73877683|NCT00867165|147295236|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|1.92||||0.501|TWO_SIDED|95.0|-3.71|7.56|||ANCOVA|||||7.56|-3.71|0.501
73877684|NCT00867165|147295237|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.18|||<|0.001|TWO_SIDED|95.0|-27.78|-20.58|||ANCOVA|||||-20.58|-27.78|<0.001
73877685|NCT00867165|147295238|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.61|||<|0.001|TWO_SIDED|95.0|-28.06|-21.16|||ANCOVA|||||-21.16|-28.06|<0.001
73877686|NCT00867165|147295239|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-26.55|||<|0.001|TWO_SIDED|95.0|-30.35|-22.75|||ANCOVA|||||-22.75|-30.35|<0.001
74001357|NCT00709852|147550976|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.01||||||95.0|-0.04|0.02|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.020|-0.040|
73877687|NCT00867165|147295240|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-9.73||||0.137|TWO_SIDED|95.0|-22.73|3.27|||Constrained longitudinal data analysis|||||3.27|-22.73|0.137
73877688|NCT00867165|147295241|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-15.19||||0.005|TWO_SIDED|95.0|-26.05|-4.34|||Constrained longitudinal data analysis|||||-4.34|-26.05|0.005
73877689|NCT00867165|147295242|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-8.61||||0.149|TWO_SIDED|95.0|-20.44|3.23|||Constrained longitudinal data analysis|||||3.23|-20.44|0.149
73877690|NCT00867165|147295243|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-1.91||||0.373|TWO_SIDED|95.0|-6.15|2.32|||ANCOVA|||||2.32|-6.15|0.373
73877691|NCT00867165|147295244|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|-19.76|||<|0.001|TWO_SIDED|95.0|-24.7|-14.82|||ANCOVA|||||-14.82|-24.70|<0.001
73877692|NCT00867165|147295245|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.83|||<|0.001|TWO_SIDED|95.0|-25.59|-16.07|||ANCOVA|||||-16.07|-25.59|<0.001
73877693|NCT00867165|147295246|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-23.48|||<|0.001|TWO_SIDED|95.0|-29.0|-17.97|||ANCOVA|||||-17.97|-29.00|<0.001
73877694|NCT00867165|147295247|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-22.29|||<|0.001|TWO_SIDED|95.0|-27.25|-17.34|||ANCOVA|||||-17.34|-27.25|<0.001
73877695|NCT00867165|147295248|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.5|||<|0.001|TWO_SIDED|95.0|-29.88|-19.12|||ANCOVA|||||-19.12|-29.88|<0.001
74036954|NCT02924688|147627127|SUPERIORITY||Least Squares Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.0226|<|0.001|TWO_SIDED|95.0|0.044|0.132||p-value was calculated using Analysis of Covariance (ANCOVA) with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.132|0.044|<0.001
74001358|NCT00709852|147550976|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01||||||95.0|-0.015|0.035|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.035|-0.015|
74001359|NCT00709852|147550977|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.042|0.153|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.153|0.042|
74001360|NCT00709852|147550977|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.03|0.161|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.161|0.030|
74001361|NCT00709852|147550977|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.05||||||95.0|0.006|0.098|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.098|0.006|
74001362|NCT00709852|147550978|SUPERIORITY_OR_OTHER||Difference|6.2||||0.0082|||||||McNemar|||||||0.0082
74001363|NCT00709852|147550979|SUPERIORITY_OR_OTHER||Difference|9.9|||<|0.0001|||||||McNemar|||||||< 0.0001
74001364|NCT00709852|147550980|SUPERIORITY_OR_OTHER||Difference|6.8||||0.0039|||||||McNemar|||||||0.0039
74001365|NCT00709852|147550981|SUPERIORITY_OR_OTHER||Difference|9.2|||<|0.0001|||||||McNemar|||||||< 0.0001
74001366|NCT00709852|147550982|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|-0.4||||||95.0|-3.8|2.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||2.9|-3.8|
74001367|NCT00709852|147550983|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||CI for paired percentages|lower limit of interval is compared to noninferiority margin||||1.6|-0.3|
74036955|NCT02924688|147627127|SUPERIORITY||Least Squares Mean Difference|0.111|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|95.0|0.067|0.155||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.155|0.067|<0.001
74001368|NCT00709852|147550984|SUPERIORITY_OR_OTHER||Difference|10.5||||0.0002|||||||McNemar|||||||0.0002
74001369|NCT00709852|147550985|SUPERIORITY_OR_OTHER||Difference|13.6|||<|0.0001|||||||McNemar|||||||< 0.0001
74001370|NCT00709852|147550986|SUPERIORITY_OR_OTHER||Difference|0.0||||1|||||||McNemar|||||||1.0000
74001371|NCT00709852|147550987|SUPERIORITY_OR_OTHER||Difference|10.5||||0.0002|||||||McNemar|||||||0.0002
74001372|NCT00709852|147550988|SUPERIORITY_OR_OTHER||Difference|13.1||||0.0001|||||||McNemar|||||||0.0001
74001373|NCT00709852|147550989|SUPERIORITY_OR_OTHER||Difference|1.6||||0.763|||||||McNemar|||||||0.7630
74001374|NCT00709852|147550990|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-3.1|3.1|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.1|-3.1|
74001375|NCT00709852|147550991|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-2.7|3.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.6|-2.7|
74001376|NCT00709852|147550992|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|-1.6||||||95.0|-10.1|6.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||6.9|-10.1|
74001377|NCT00709852|147550993|SUPERIORITY_OR_OTHER||Difference|6.5||||0.0006|||||||McNemar|||||||0.0006
74001378|NCT00709852|147550994|SUPERIORITY_OR_OTHER||Difference|19.4||||0.0004|||||||McNemar|||||||0.0004
74001379|NCT00709852|147550995|SUPERIORITY_OR_OTHER||Difference|0.5||||0.6547|||||||McNemar|||||||0.6547
74001380|NCT00709852|147550996|SUPERIORITY_OR_OTHER||Difference|7.9|||<|0.0001|||||||McNemar|||||||< 0.0001
74001381|NCT00709852|147550997|SUPERIORITY_OR_OTHER||Difference|21.5|||<|0.0001|||||||McNemar|||||||< 0.0001
74001382|NCT00709852|147550998|SUPERIORITY_OR_OTHER||Difference|1.5||||0.0833|||||||McNemar|||||||0.0833
74001383|NCT00709852|147550999|SUPERIORITY_OR_OTHER||Difference|4.5||||0.0236|||||||McNemar|||||||0.0236
74001384|NCT00709852|147551000|SUPERIORITY_OR_OTHER||Difference|12.9||||0.0186|||||||McNemar|||||||0.0186
74001385|NCT00709852|147551001|SUPERIORITY_OR_OTHER||Difference|0.5||||0.7055|||||||McNemar|||||||0.7055
74036956|NCT02924688|147627127|SUPERIORITY||Least Squares Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|95.0|0.044|0.132||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.132|0.044|<0.001
74036957|NCT02924688|147627127|SUPERIORITY||Least Squares Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.074|0.162||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.162|0.074|<0.001
74036958|NCT02924688|147627128|SUPERIORITY||Least Squares Mean Difference|-0.057|STANDARD_ERROR_OF_MEAN|0.034||0.094|TWO_SIDED|95.0|-0.124|0.01||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.010|-0.124|0.094
74036959|NCT02924688|147627128|SUPERIORITY||Least Squares Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.0338||0.008|TWO_SIDED|95.0|-0.156|-0.023||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||-0.023|-0.156|0.008
74036960|NCT02924688|147627129|OTHER||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.697||0.115|TWO_SIDED|95.0|-0.27|2.47||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||2.47|-0.27|0.115
74036961|NCT02924688|147627129|OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.692||0.662|TWO_SIDED|95.0|-1.66|1.05||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.05|-1.66|0.662
73877696|NCT00867165|147295249|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-25.15|||<|0.001|TWO_SIDED|95.0|-30.69|-19.62|||ANCOVA|||||-19.62|-30.69|<0.001
73877697|NCT00867165|147295250|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-29.31|||<|0.001|TWO_SIDED|95.0|-35.71|-22.91|||ANCOVA|||||-22.91|-35.71|<0.001
74001386|NCT00709852|147551002|SUPERIORITY_OR_OTHER||Difference|7.2|||<|0.0001|||||||McNemar|||||||< 0.0001
74001387|NCT00709852|147551003|SUPERIORITY_OR_OTHER||Difference|20.4|||<|0.0001|||||||McNemar|||||||< 0.0001
74001388|NCT00709852|147551004|SUPERIORITY_OR_OTHER||Difference|1.0||||0.1573|||||||McNemar|||||||0.1573
74001389|NCT00709852|147551005|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|2.1||||||95.0|0.2|3.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.9|0.2|
74001390|NCT00709852|147551006|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|6.5||||||95.0|1.5|11.4|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||11.4|1.5|
74001391|NCT00709852|147551007|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-1.4|1.4|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.4|-1.4|
74001392|NCT00709852|147551008|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.6|-0.3|
74001393|NCT00709852|147551009|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|1.1||||||95.0|-1.0|3.2|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.2|-1.0|
74001394|NCT00709852|147551010|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-0.5|1.5|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.5|-0.5|
74001395|NCT00709852|147551011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_DEVIATION|0.56|<|0.0001|||||||paired t test|||||||< 0.0001
74001396|NCT00709852|147551012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_DEVIATION|0.58|<|0.0001|||||||paired t test|||||||< 0.0001
74001397|NCT00709852|147551013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.48||||||||||||||||
74036962|NCT02924688|147627130|OTHER||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.185||0.479|TWO_SIDED|95.0|-0.49|0.23||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures|||||0.23|-0.49|0.479
74036963|NCT02924688|147627130|OTHER||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.184||0.023|TWO_SIDED|95.0|-0.78|-0.06||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures|||||-0.06|-0.78|0.023
74090837|NCT00557076|147735800|NON_INFERIORITY_OR_EQUIVALENCE|Because 50% of the planned sample size was randomized, achieved power for the DOCS is 0.51.|Mean Difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|7.0||0.465|TWO_SIDED|95.0|-11.1|21.9|||t-test, 1 sided|DOCS scores were transformed to interval level measures using a many-faceted Rasch model anchored to values from a larger validation data set|The mean difference between the baseline and endpoint DOCS test was compared between the FAST and Sham groups.|The planned sample of 15 per group provided 80% power for a one-sided t-test to detect be-tween group endpoint differences in DOCS averages equivalent to an effect size of .91 (9 units). Clinically, this assumes that the FAST protocol would facilitate progression from one clinical state to another (e.g., vegetative (VS) to minimally conscious (MCS) states). The hypothesized effect was based on average DOCS change for a severe TBI sample receiving three weeks of acute rehabilitation.||21.9|-11.1|.465
74001398|NCT00709852|147551014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.93|<|0.0001|||||||paired t test|||||||< 0.0001
74001399|NCT00709852|147551015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_DEVIATION|0.89|<|0.0001|||||||paired t test|||||||< 0.0001
74001400|NCT00709852|147551016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.39||||||||||||||||
74001401|NCT00709852|147551017|SUPERIORITY_OR_OTHER||||||<|0.0001||||||for all three readers|t-test, 2 sided|||||||< 0.0001
74001402|NCT00709852|147551019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|1.06||||||||||||||||
74001403|NCT00709852|147551020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|26.6||||||||||||||||
74001404|NCT05249829|147551044|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.73|||||TWO_SIDED|99.0|1.493|2.005||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||2.005|1.493|
74001405|NCT05249829|147551045|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.763|||||TWO_SIDED|96.0|1.546|2.01||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration.||2.010|1.546|
74001406|NCT05249829|147551046|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667. Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.535|||||TWO_SIDED|99.0|1.409|1.672||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||1.672|1.409|
74001407|NCT05249829|147551047|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667. Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.713|||||TWO_SIDED|96.0|1.583|1.853||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration.||1.853|1.583|
74001408|NCT05249829|147551048|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.048|||||TWO_SIDED|99.0|0.958|1.147||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the ancestral strain at Day 29 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=1818).||1.147|0.958|
73877698|NCT00867165|147295251|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-28.35|||<|0.001|TWO_SIDED|95.0|-34.41|-22.29|||ANCOVA|||||-22.29|-34.41|<0.001
74001409|NCT05249829|147551049|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.104|||||TWO_SIDED|96.0|1.032|1.18||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the ancestral strain at Day 85 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=1418).||1.180|1.032|
74001410|NCT05249829|147551056|SUPERIORITY|Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.73|||||TWO_SIDED|99.0|1.493|2.005||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||2.005|1.493|
74001411|NCT05249829|147551056|SUPERIORITY|Superiority was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.763|||||TWO_SIDED|96.0|1.546|2.01||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=460).||2.010|1.546|
74001412|NCT02842827|147551150|OTHER|||||||0.3868|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.3868
74001413|NCT02842827|147551151|OTHER|||||||0.7744|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.7744
74001414|NCT02842827|147551152|OTHER|||||||0.508|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.5080
74001415|NCT02842827|147551153|OTHER|||||||0.6109|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.6109
74001416|NCT02842827|147551154|OTHER|||||||0.1151|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.1151
74001417|NCT02842827|147551155|OTHER|||||||0.0791|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.0791
74001418|NCT01043393|147551156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.779|||||TWO_SIDED|95.0|0.055|11.126||||||||11.126|0.055|
74001419|NCT02673515|147551207|OTHER|||||||0.797|||||||t-test, 2 sided|||Comparison of changes from baseline to 4 weeks between groups was tested with student´s t-test or Mann Whitney-U-Test||||0.797
74001420|NCT00903682|147551250|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||The hypothesis is that the proportion of patients with at least 1 treatment-emergent Grade 1-4 neuropsychiatric adverse event, observed between Baseline through Week 12 and judged to be at least possibly drug-related, is significantly lower in the ETR arm than in the EFV arm. Assuming a significance level of 5%, a sample size of 75 subjects per arm would provide over 90% power to detect a 29% difference in treatment-emergent, drug-related Grade 1-4 neuropsychiatric adverse events.||||<0.001
74036964|NCT02924688|147627133|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.75||0.172|TWO_SIDED|95.0|-2.5|0.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||0.4|-2.5|0.172
74036965|NCT02924688|147627133|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.74||0.436|TWO_SIDED|95.0|-2.0|0.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||0.9|-2.0|0.436
73877699|NCT00867165|147295252|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-19.28|||<|0.001|TWO_SIDED|95.0|-23.87|-14.7|||ANCOVA|||||-14.70|-23.87|<0.001
73877700|NCT00867165|147295253|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-46.11||||0.116|TWO_SIDED|95.0|-108.14|15.92|||Constrained longitudinal data analysis|||||15.92|-108.14|0.116
73877701|NCT00867165|147295254|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|17.27||||0.382|TWO_SIDED|95.0|-20.46|55.0|||Constrained longitudinal data analysis|||||55.00|-20.46|0.382
74001421|NCT00903682|147551251|SUPERIORITY_OR_OTHER||Difference in proportion of response|1.61|||||TWO_SIDED|95.0|-12.0|15.23|||||Difference in proportion of response ETR minus EFV|||15.23|-12.00|
74001422|NCT00932113|147551257|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74001423|NCT00896051|147551272|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.82|||||TWO_SIDED|90.0|0.55|1.22|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: minimum plasma concentration (Cmin)||1.22|0.55|
74001424|NCT00896051|147551272|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Ratio|0.96|||||TWO_SIDED|90.0|0.8|1.16|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: maximum plasma concentration (Cmax)||1.16|0.80|
74001425|NCT00896051|147551273|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.96|||||TWO_SIDED|90.0|0.76|1.22|||Linear mixed effects model|linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)||1.22|0.76|
74001426|NCT00896051|147551274|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.91|||||TWO_SIDED|90.0|0.63|1.33|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: Minimum plasma concentration (Cmin)||1.33|0.63|
74001427|NCT00896051|147551274|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|1.05|||||TWO_SIDED|90.0|0.86|1.27|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: maximum plasma concentration (Cmax)||1.27|0.86|
74001428|NCT00896051|147551275|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.99|||||TWO_SIDED|90.0|0.81|1.21|||Llinear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)||1.21|0.81|
74090838|NCT00557076|147735801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.346||0.049|TWO_SIDED|95.0|-1.51|-0.00493|||t-test, 1 sided|CNC scores were transformed to interval level measures using Rasch partial credit and Facets models. We then re-scaled these logits to 0-100 scales.|The mean difference was calculated for each group using the eighth CNC measure minus the Baseline CNC measure.|Power was not calculated for the CNC because the effect size was not published.||-.00493|-1.51|0.049
73877702|NCT00867165|147295255|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-49.61|||<|0.001|TWO_SIDED|95.0|-55.36|-43.87|||ANCOVA|||||-43.87|-55.36|<0.001
73877703|NCT00867165|147295256|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-58.52|||<|0.001|TWO_SIDED|95.0|-63.67|-53.38|||ANCOVA|||||-53.38|-63.67|<0.001
74001429|NCT00876928|147551294|SUPERIORITY_OR_OTHER||Percent of patients developing diabetes|10.0||||0.61|TWO_SIDED|95.0|8.0|12.0||A chi square test was used for the number of participants developing diabetes and a 2-way repeated measures ANOVA for the disposition index|Chi-squared||Primary outcome compared the number of participants developing diabetes after receiving vitamin D or placebo for one year. Secondary outcome compared changes in 2-way repeated measures ANOVA; therefore,no confidence intervals/dispersion parameters|Null hypothesis is that there is no effect of vitamin D on the development of diabetes in people with pre-diabetes and hypovitaminosis D. There were no published data when this trial was started on the effect of vitamin D in pre-diabetes making a power calculation difficult.||12|8|0.61
74001430|NCT00876928|147551295|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||ANOVA|||The null hypothesis is that there would be no difference in the changes in the Disposition Index between the 2 groups over the year.||||0.39
74001431|NCT00522873|147551358|SUPERIORITY_OR_OTHER||proportion|0.0|||||TWO_SIDED|95.0|0.0|0.0119|||||The number of women who had a biopsy classified as 'hyperplasia or worse' was divided by the number of women with an evaluable biopsy (i.e. classified as 'normal' after 1 year of treatment or as 'hyperplasia or worse' at any time during the study).|Exact 95% confidence interval for proportion of participants with hyperplasia or worse at EoS||0.0119|0.0000|
74001432|NCT00522873|147551359|SUPERIORITY_OR_OTHER||proportion|0.687|||||TWO_SIDED|95.0|0.637|0.734||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.734|0.637|
74001433|NCT00522873|147551359|SUPERIORITY_OR_OTHER||proportion|0.593|||||TWO_SIDED|95.0|0.496|0.684||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.684|0.496|
74001434|NCT00522873|147551360|SUPERIORITY_OR_OTHER||proportion|0.789|||||TWO_SIDED|95.0|0.743|0.83||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.830|0.743|
74001435|NCT00522873|147551360|SUPERIORITY_OR_OTHER||proportion|0.84|||||TWO_SIDED|95.0|0.756|0.904||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.904|0.756|
74001436|NCT00822172|147551366|SUPERIORITY|||||||0.076|||||||two-sample equal-variances t-test|||||||0.076
74090839|NCT00557076|147735801|SUPERIORITY_OR_OTHER||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.0022|TWO_SIDED|||||To confirm that CNC results were not an anomaly at the final measurement and that the overall CNC response pattern was consistent, mixed-effect longitudinal models were conducted.|t-test, 1 sided||The Baseline CNC measure and seven post-Baseline CNC measures (for a total of eight CNC measures) were used to calculate the slope.|||||.0022
73877704|NCT00867165|147295257|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-61.02|||<|0.001|TWO_SIDED|95.0|-67.51|-54.53|||ANCOVA|||||-54.53|-67.51|<0.001
73877705|NCT00867165|147295258|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-62.74||||0.001|TWO_SIDED|95.0|-73.22|-52.26|||ANCOVA|||||-52.26|-73.22|0.001
73877706|NCT00867165|147295259|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-49.48|||<|0.001|TWO_SIDED|95.0|-54.83|-44.14|||ANCOVA|||||-44.14|-54.83|<0.001
73877707|NCT00867165|147295260|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-57.99|||<|0.001|TWO_SIDED|95.0|-62.87|-53.11|||ANCOVA|||||-53.11|-62.87|<0.001
73877708|NCT00867165|147295261|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-62.6|||<|0.001|TWO_SIDED|95.0|-68.54|-56.66|||ANCOVA|||||-56.66|-68.54|<0.001
73877709|NCT00867165|147295262|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-64.67|||<|0.001|TWO_SIDED|95.0|-74.11|-55.23|||ANCOVA|||||-55.23|-74.11|<0.001
73877710|NCT00867165|147295263|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-18.35|||<|0.001|TWO_SIDED|95.0|-24.7|-11.99|||ANCOVA|||||-11.99|-24.70|<0.001
73877711|NCT00867165|147295264|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-25.61|||<|0.001|TWO_SIDED|95.0|-31.2|-20.02|||ANCOVA|||||-20.02|-31.20|<0.001
73877712|NCT00867165|147295265|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-28.74|||<|0.001|TWO_SIDED|95.0|-34.89|-22.59|||ANCOVA|||||-22.59|-34.89|<0.001
73877713|NCT00867165|147295266|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-32.14|||<|0.001|TWO_SIDED|95.0|-40.38|-23.9|||ANCOVA|||||-23.90|-40.38|<0.001
74001437|NCT00822172|147551367|SUPERIORITY|||||||0.048|||||||two-sample equal-variances t-test|||||||0.048
74001438|NCT00822172|147551368|SUPERIORITY|||||||0.65|||||||two-sample equal-variances t-test|||||||0.650
74001439|NCT00757588|147551408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED|95.0|-0.59|-0.24||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-0.24|-0.59|<0.0001
74001440|NCT00757588|147551409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3829.8|STANDARD_ERROR_OF_MEAN|1165.99||0.0011|TWO_SIDED|95.0|-6122.4|-1537.1||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-1537.1|-6122.4|0.0011
73957203|NCT04771273|147450406|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73877714|NCT00867165|147295267|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|20.01||||0.001|TWO_SIDED|95.0|8.1|31.91|||ANCOVA|||||31.91|8.10|0.001
73957204|NCT04771273|147450406|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957205|NCT04771273|147450406|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957206|NCT04771273|147450407|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|5.49|||<|0.0001|TWO_SIDED|95.0|2.46|12.28||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||12.28|2.46|<.0001
73957207|NCT04771273|147450407|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|10.14|||<|0.0001|TWO_SIDED|95.0|4.49|22.87||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||22.87|4.49|<.0001
73957208|NCT04771273|147450407|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|4.87||||0.0001|TWO_SIDED|95.0|2.18|10.91||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||10.91|2.18|0.0001
73957209|NCT04771273|147450407|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0001|||||||MCPMod linear model fit|linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0001
73957210|NCT04771273|147450407|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0115|||||||MCPMod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0115
74001441|NCT00757588|147551410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.0|STANDARD_ERROR_OF_MEAN|7.24||0.0016|TWO_SIDED|95.0|-37.2|-8.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-8.7|-37.2|0.0016
74001442|NCT00757588|147551411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|STANDARD_ERROR_OF_MEAN|4.732||0.3958|TWO_SIDED|95.0|-13.32|5.28||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||5.28|-13.32|0.3958
74001443|NCT00757588|147551413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-5.6|-1.1||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-1.1|-5.6|
74001444|NCT01052103|147551422|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.0|STANDARD_ERROR_OF_MEAN|1.6||0.732||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.732
74001445|NCT01052103|147551423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|2.2|STANDARD_ERROR_OF_MEAN|2.1||0.846||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.846
74001446|NCT01052103|147551424|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.201||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.201
74001447|NCT01052103|147551425|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.4|STANDARD_ERROR_OF_MEAN|1.3||0.136||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.136
74001448|NCT01052103|147551426|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.5|STANDARD_ERROR_OF_MEAN|2.4||0.739||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.739
74001449|NCT01052103|147551427|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.19||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.190
74001450|NCT01052103|147551428|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.702||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.702
74001451|NCT01052103|147551429|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.851||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.851
74001452|NCT01052103|147551433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0||||0.999|TWO_SIDED|95.0|-4.3|4.3||P-value is for standing systolic BP.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||4.3|-4.3|0.999
74001453|NCT01052103|147551433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|3.8||||0.009|TWO_SIDED|95.0|1.0|6.7||P-value is for standing diastolic BP.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||6.7|1.0|0.009
74008762|NCT02632721|147567640|OTHER||Probability of DLT rate in [0.33, 1)|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
74008763|NCT02632721|147567640|OTHER||Probability of DLT rate in [0.16, 0.33)|0.028|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
73877715|NCT00867165|147295268|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|26.29|||<|0.001|TWO_SIDED|95.0|13.99|38.58|||ANCOVA|||||38.58|13.99|<0.001
74001454|NCT01052103|147551434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5||||0.818|TWO_SIDED|95.0|-5.0|3.9|||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||3.9|-5.0|0.818
74001455|NCT01052103|147551435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.44||||0.571|TWO_SIDED|95.0|-1.98|1.1|||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||1.10|-1.98|0.571
74001456|NCT01052103|147551440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.682||95.0||||P-value is for treatment-emergent suicidal ideation.|Fisher Exact|||||||0.682
74001457|NCT01052103|147551441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.0|STANDARD_ERROR_OF_MEAN|1.7||0.727||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.727
74001458|NCT01052103|147551445|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.7|STANDARD_ERROR_OF_MEAN|3.4||0.305||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.305
74001459|NCT01052103|147551446|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5|STANDARD_ERROR_OF_MEAN|2.5||0.42||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.420
74001460|NCT05398237|147551486|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0122||||||Change in pathway from baseline to 1 hour post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK).|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study||||0.0122
74001461|NCT05398237|147551486|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.009||||||Change in pathway from baseline to 24 hours post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study.||||0.009
74001462|NCT05398237|147551487|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0063||||||Change in pathway from baseline to 1 hour post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study||||0.0063
74001463|NCT05398237|147551487|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0056||||||Change in pathway from baseline to 24 hours post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study.||||0.0056
74036966|NCT02924688|147627133|OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.75||0.426|TWO_SIDED|95.0|-0.9|2.1||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||2.1|-0.9|0.426
74036967|NCT02924688|147627133|OTHER||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.74||0.349|TWO_SIDED|95.0|-0.8|2.2||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||2.2|-0.8|0.349
74036968|NCT02924688|147627133|OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.482|TWO_SIDED|95.0|-1.5|0.7||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||0.7|-1.5|0.482
74036969|NCT02924688|147627133|OTHER||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.56||0.142|TWO_SIDED|95.0|-0.3|1.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.9|-0.3|0.142
73877716|NCT00867165|147295269|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|36.7|||<|0.001|TWO_SIDED|95.0|24.12|49.28|||ANCOVA|||||49.28|24.12|<0.001
73877717|NCT00867165|147295270|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|24.05|||<|0.001|TWO_SIDED|95.0|10.43|37.67|||ANCOVA|||||37.67|10.43|<0.001
74036970|NCT02924688|147627133|OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.56||0.806|TWO_SIDED|95.0|-1.2|1.0||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.0|-1.2|0.806
74036971|NCT02924688|147627133|OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.447|TWO_SIDED|95.0|-0.7|1.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.5|-0.7|0.447
74036972|NCT02924688|147627134|OTHER||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.61||0.034|TWO_SIDED|95.0|0.1|2.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||2.5|0.1|0.034
74036973|NCT02924688|147627134|OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.839|TWO_SIDED|95.0|-1.1|1.3||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.3|-1.1|0.839
74090840|NCT04017754|147735812|EQUIVALENCE|A p-value \<0.05 was considered significant for at difference in frequency of low p-MBL level(\<500 ug/l) between groups.|Prevalence proportion ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.34|2.38|||Chi-squared||The numerator is the risk of low p-MBL in the study sample with RPL patients and the denominator is the risk of low p-MBL in control group 1 of female blood donors.|Comparing the risk of low p-MBL level between RPL patients and MBL reference group. We hypothesized that more RPL patients had a low p-MBL level; thus, the null hypothesis was that no difference existed.||2.38|1.34|<0.001
74090841|NCT00534794|147735859|SUPERIORITY_OR_OTHER|||||||0.532||95.0|||||ANCOVA|||ITT (Intent to Treat)||||0.532
74090842|NCT00534794|147735860|SUPERIORITY_OR_OTHER|||||||0.927||95.0|||||Student's t-test|||ITT (Intent to Treat)||||0.927
74001464|NCT00666679|147551489|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||0.033||95.0|0.0|0.09|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.09|0.00|0.033
74001465|NCT00666679|147551490|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.15||||0.005||95.0|-0.26|-0.05|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||-0.05|-0.26|0.005
74001466|NCT00666679|147551491|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.09||||0.015||95.0|-0.17|-0.02|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||-0.02|-0.17|0.015
74001467|NCT00666679|147551492|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.6||||0.073||95.0|-1.26|0.06|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.06|-1.26|0.073
74001468|NCT00666679|147551493|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|6.08||||0.004||95.0|1.94|10.23|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.|Least-Squares Means for average percentage of days are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.|||10.23|1.94|0.004
74091723|NCT05472662|147737053|OTHER||Adjusted mean difference|0.015||||0.519|TWO_SIDED|95.0|-0.032|0.061|||ANCOVA|||"Statistical analysis performed on the data at 5 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.061|-0.032|0.519
74001469|NCT00666679|147551494|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-5.43|||<=|0.001||95.0|-8.67|-2.19|||ANCOVA|Model with terms for patient, treatment and period.|Least-Squares Means for percentage of days are derived from ANCOVA model with terms for patient, treatment and period.|||-2.19|-8.67|<=0.001
74001470|NCT00666679|147551495|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.07||||0.013||95.0|-0.12|-0.01|||Mixed Models Analysis|Model with fixed effects for treatment, period and baseline covariate.|Least-Squares Means for change from baseline are derived from mixed model with terms for treatment, period and baseline covariate.|||-0.01|-0.12|0.013
74036974|NCT02924688|147627134|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.61||0.349|TWO_SIDED|95.0|-1.8|0.6||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.6|-1.8|0.349
74090843|NCT00899470|147735867|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.011|||||TWO_SIDED|90.0|0.94|1.088|||Mixed Models Analysis|Bioequivalence=90% confidence intervals (CIs) for the test|For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate bioequivalence (BE) of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.940|
74090844|NCT00899470|147735867|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs Reference|0.999|||||TWO_SIDED|90.0|0.929|1.075||||Bioequivalence=90% CIs for the test|For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.075|0.929|
74090845|NCT00899470|147735868|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||TWO_SIDED|90.0|0.993|1.066|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted and fed states, linear mixed model analysis was performed on log\[AUC(0-T)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.066|0.993|
74036975|NCT02924688|147627134|OTHER||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.61||0.768|TWO_SIDED|95.0|-1.0|1.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.4|-1.0|0.768
74036976|NCT00848250|147627141|SUPERIORITY|||||||0.03|||||||ANOVA|||||||0.03
74036977|NCT00848250|147627142|SUPERIORITY|||||||0.13|||||||ANOVA|Repeated measures||||||0.13
74036978|NCT00848250|147627143|SUPERIORITY|||||||0.02|||||||ANOVA|Repeated measures||||||0.02
74036979|NCT00848250|147627144|SUPERIORITY|||||||0.67|||||||ANOVA|Repeated measures||||||0.67
74036980|NCT00848250|147627146|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||P-value is for comparison of chest tube output at 24 hours||||0.47
74036981|NCT00848250|147627147|SUPERIORITY|||||||0.41|||||||Fisher Exact|||||||0.41
74036982|NCT03943953|147627179|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.018|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.018
74036983|NCT03943953|147627181|SUPERIORITY||Mean Difference (Final Values)|3.88||||0.001|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.001
74036984|NCT03943953|147627183|SUPERIORITY||Mean Difference (Final Values)|3.88||||0.006|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.006
74036985|NCT03943953|147627185|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.035|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.035
74036986|NCT03943953|147627187|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.39|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.39
74036987|NCT00711269|147627235|SUPERIORITY|One-way Analysis of Variance (ANOVA)|LS Mean difference|-3.5||||0.149|TWO_SIDED|95.0|-8.4|1.3|||ANOVA||\[Not specified\]|||1.3|-8.4|0.149
74036988|NCT00711269|147627235|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.8||||0.462|TWO_SIDED|95.0|-6.6|3.0|||ANOVA|||||3.0|-6.6|0.462
74036989|NCT00711269|147627235|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-4.6||||0.122|TWO_SIDED|95.0|-10.5|1.2|||ANOVA|||||1.2|-10.5|0.122
74036990|NCT00711269|147627235|SUPERIORITY|Maximum Contrast Method||||||0.235||||||Contrast Factors (Placebo, SM-13496 40-mg, SM-13496 80-mg): (-1, 0, 1) Adjusted P Value: 0.298|Maximum Contrast Method|Contrast (Placebo, SM-13496 40-mg, SM-13496 80-mg):(-2, 1, 1) Raw P Value: 0.108 Adjusted P Value: 0.145||||||0.235
74036991|NCT00711269|147627236|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.069|TWO_SIDED|95.0|-2.9|0.1|||ANOVA|||||0.1|-2.9|0.069
74036992|NCT00711269|147627236|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.8||||0.287|TWO_SIDED|95.0|-2.3|0.7|||ANOVA|||||0.7|-2.3|0.287
74036993|NCT00711269|147627236|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-2.3||||0.016|TWO_SIDED|95.0|-4.1|-0.4|||ANOVA|||||-0.4|-4.1|0.016
74036994|NCT00711269|147627237|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.289|TWO_SIDED|95.0|-2.0|0.6|||ANOVA|||||0.6|-2.0|0.289
74036995|NCT00711269|147627237|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.256|TWO_SIDED|95.0|-2.0|0.5|||ANOVA|||||0.5|-2.0|0.256
74036996|NCT00711269|147627237|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.352|TWO_SIDED|95.0|-2.3|0.8|||ANOVA|||||0.8|-2.3|0.352
74090846|NCT00899470|147735868|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio|1.021|||||TWO_SIDED|90.0|0.986|1.058|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(0-T)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.058|0.986|
74090847|NCT00899470|147735869|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.027|||||TWO_SIDED|90.0|0.99|1.066|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(INF)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.066|0.990|
74091724|NCT05472662|147737053|OTHER||Adjusted mean difference|0.061||||0.085|TWO_SIDED|95.0|-0.009|0.13|||ANCOVA|||"Statistical analysis performed on the data at 15 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.130|-0.009|0.085
74091725|NCT05472662|147737053|OTHER||Adjusted mean difference|0.004||||0.858|TWO_SIDED|95.0|-0.045|0.054|||ANCOVA|||"Statistical analysis performed on the data at 30 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.054|-0.045|0.858
74001471|NCT00666679|147551496|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||0.002||95.0|0.03|0.13|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.13|0.03|0.002
74001472|NCT05062759|147551511|OTHER||Geometric Least square (LS) mean ratio|0.65|||||TWO_SIDED|90.0|0.43|0.98||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model.||0.98|0.43|
74001473|NCT05062759|147551511|OTHER||Geometeric LS mean ratio|0.83|||||TWO_SIDED|90.0|0.6|1.15||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.15|0.60|
74001474|NCT05062759|147551511|OTHER||Geometric LS mean ratio|0.99|||||TWO_SIDED|90.0|0.71|1.37||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.37|0.71|
74001475|NCT05062759|147551512|OTHER||Geometeric LS mean ratio|0.73|||||TWO_SIDED|90.0|0.42|1.28||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.28|0.42|
74001476|NCT05062759|147551512|OTHER||Geometeric LS mean ratio|1.25|||||TWO_SIDED|90.0|0.72|2.17||||||Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model||2.17|0.72|
74001477|NCT05062759|147551512|OTHER||Geometric LS mean ratio|1.23|||||TWO_SIDED|90.0|0.73|2.07||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||2.07|0.73|
74001478|NCT05062759|147551512|OTHER||Geometeric LS mean ratio|0.89|||||TWO_SIDED|90.0|0.54|1.48||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.48|0.54|
74001479|NCT05062759|147551513|OTHER||Geometeric LS mean ratio|0.74|||||TWO_SIDED|90.0|0.52|1.04||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.04|0.52|
74001480|NCT05062759|147551513|OTHER||Geometeric LS mean ratio|0.96|||||TWO_SIDED|90.0|0.72|1.29||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.29|0.72|
74001481|NCT05062759|147551513|OTHER||Geometric LS mean ratio|1.03|||||TWO_SIDED|90.0|0.73|1.46||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.46|0.73|
74001482|NCT05062759|147551514|OTHER||Geometeric LS mean ratio|0.79|||||TWO_SIDED|90.0|0.51|1.25||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.25|0.51|
74001483|NCT05062759|147551514|OTHER||Geometeric LS mean ratio|0.76|||||TWO_SIDED|90.0|0.42|1.28||||||Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.28|0.42|
74001484|NCT05062759|147551514|OTHER||Geometric LS mean ratio|0.99|||||TWO_SIDED|90.0|0.49|1.99||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.99|0.49|
74001485|NCT05062759|147551514|OTHER||Geometeric LS mean ratio|1.03|||||TWO_SIDED|90.0|0.7|1.52||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.52|0.70|
74008764|NCT02632721|147567640|OTHER||Posterior probability of the DLT rate ly|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
74036997|NCT00711269|147627238|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.251|TWO_SIDED|95.0|-3.9|1.0|||ANOVA|||||1.0|-3.9|0.251
74036998|NCT00711269|147627238|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.2||||0.847|TWO_SIDED|95.0|-2.7|2.2|||ANOVA|||||2.2|-2.7|0.847
74036999|NCT00711269|147627238|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.6||||0.292|TWO_SIDED|95.0|-4.6|1.4|||ANOVA|||||1.4|-4.6|0.292
74037000|NCT01551758|147627242|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|0.92|||=|0.025|TWO_SIDED|95.0|0.85|0.99|||Generalized Linear Model|||||0.99|0.85|=0.025
74037001|NCT01551758|147627243|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.1|||||TWO_SIDED|95.0|0.9|1.5|||||Calculated as % of participants who had at least one SAE of pneumonia in the FF/VI group divided by the % of participants who had at least one SAE of pneumonia in the Usual Care group|||1.5|0.9|
74037002|NCT01551758|147627244|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.08||||0.632|TWO_SIDED|95.0|0.79|1.47|||Generalized linear model|||||1.47|0.79|0.632
74037003|NCT01551758|147627245|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||=|0.439|TWO_SIDED|95.0|0.83|1.52|||Cox proportional hazards model|||||1.52|0.83|=0.439
74037004|NCT01551758|147627246|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.06||||0.488|TWO_SIDED|95.0|0.89|1.27|||Generalized linear model|||||1.27|0.89|0.488
74037005|NCT01551758|147627247|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|0.98||||0.622|TWO_SIDED|95.0|0.92|1.05|||Generalized linear model|||||1.05|0.92|0.622
74037006|NCT01551758|147627248|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.05||||0.336|TWO_SIDED|95.0|0.95|1.15|||Generalized Linear Model|||||1.15|0.95|0.336
74037007|NCT01551758|147627249|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.12|||<|0.001|TWO_SIDED|95.0|1.05|1.2|||Generalized Linear Model|||||1.20|1.05|<0.001
74037008|NCT01551758|147627250|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.89|||<|0.001|TWO_SIDED|95.0|1.6|2.23|||Cox proportional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care.|||2.23|1.60|<0.001
74037009|NCT01551758|147627251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.37|0.66|||Cox proprotional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care|||0.66|0.37|<0.001
74037010|NCT01551758|147627252|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.111|TWO_SIDED|95.0|0.85|1.02|||Cox porportional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care|||1.02|0.85|0.111
74037011|NCT01551758|147627253|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.081|TWO_SIDED|95.0|0.84|1.01|||Cox porportional hazards model|||||1.01|0.84|0.081
74037012|NCT01551758|147627254|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.075|TWO_SIDED|95.0|0.98|1.66|||Cox proportional hazards model|||||1.66|0.98|0.075
74037013|NCT04593940|147627259|SUPERIORITY||Recovery Rate Ratio|1.122||||0.0793|TWO_SIDED|95.0|0.987|1.275|||Fine-Gray Proportional Hazards Model|||||1.275|0.987|0.0793
74037014|NCT04593940|147627259|SUPERIORITY||Recovery Rate Ratio|1.12||||0.0864|TWO_SIDED|95.0|0.984|1.275|||Fine-Gray Proportional Hazards Model|||||1.275|.984|0.0864
74037015|NCT04593940|147627259|SUPERIORITY||Recovery Rate Ratio|1.006||||0.9354|TWO_SIDED|95.0|0.862|1.176|||Fine-Gray Proportional Hazards Model|||||1.176|0.862|0.9354
74037016|NCT04593940|147627260|SUPERIORITY||Odds Ratio (OR)|1.309||||0.0213|TWO_SIDED|95.0|1.041|1.647|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.647|1.041|0.0213
74037017|NCT04593940|147627260|SUPERIORITY||Odds Ratio (OR)|1.174||||0.1732|TWO_SIDED|95.0|0.932|1.48|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.480|0.932|0.1732
74037018|NCT04593940|147627260|SUPERIORITY||Odds Ratio (OR)|0.944||||0.6823|TWO_SIDED|95.0|0.717|1.243|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.243|0.717|0.6823
74037019|NCT04593940|147627261|SUPERIORITY||Odds Ratio (OR)|0.614||||0.0229|TWO_SIDED|95.0|0.403|0.935|||Regression, Logistic|||||0.935|0.403|0.0229
74037020|NCT04593940|147627261|SUPERIORITY||Odds Ratio (OR)|0.629||||0.0281|TWO_SIDED|95.0|0.416|0.951|||Regression, Logistic|||||0.951|0.416|0.0281
74037021|NCT04593940|147627261|SUPERIORITY||Odds Ratio (OR)|1.167||||0.541|TWO_SIDED|95.0|0.711|1.917|||Regression, Logistic|||||1.917|0.711|0.541
74037022|NCT04593940|147627262|SUPERIORITY||Odds Ratio (OR)|1.435||||0.0032|TWO_SIDED|95.0|1.129|1.825|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.825|1.129|0.0032
74037023|NCT04593940|147627262|SUPERIORITY||Odds Ratio (OR)|1.338||||0.0228|TWO_SIDED|95.0|1.041|1.718|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.718|1.041|0.0228
74037024|NCT04593940|147627262|SUPERIORITY||Odds Ratio (OR)|0.904||||0.4994|TWO_SIDED|95.0|0.675|1.211|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.211|0.675|0.4994
74037025|NCT04593940|147627263|SUPERIORITY||Odds Ratio (OR)|0.632||||0.0988|TWO_SIDED|95.0|0.367|1.09|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.090|0.367|0.0988
74037026|NCT04593940|147627263|SUPERIORITY||Odds Ratio (OR)|0.552||||0.0354|TWO_SIDED|95.0|0.317|0.96|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||0.960|0.317|0.0354
73877718|NCT00890825|147295271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2069|TWO_SIDED|80.0|0.56|1.14||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure - Overall survival.|Regression, Cox|Analysis adjusted for the following covariates; WHO PS, gender, histology and smoking status|A Hazard Ratio less than 1 favoured AZD6244 + Docetaxel|||1.14|0.56|0.2069
73877719|NCT00890825|147295272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0138|TWO_SIDED|80.0|0.42|0.79||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Regression, Cox|The model allowed for the effect of treatment and included terms for WHO PS, gender, histology, and smoking status.|A Hazard Ratio (HR) \< 1 favoured AZD6244 + Docetaxel|||0.79|0.42|0.0138
73877720|NCT00890825|147295273|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|37.2|||<|0.0001|TWO_SIDED|95.0|23.0|53.0||Two-sided P-value|Fisher Exact|||||53|23|< 0.0001
73877721|NCT00890825|147295275|SUPERIORITY_OR_OTHER||LSmeans difference|-17.03||||0.004|TWO_SIDED|80.0|-25.2|-8.86||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status.|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)|||-8.86|-25.2|0.004
73877722|NCT00890825|147295276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0||||0.004|TWO_SIDED|80.0|-38.34|-13.7||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)|||-13.7|-38.34|0.004
73877723|NCT00890825|147295277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0158|TWO_SIDED|80.0|0.37|0.78||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Log Rank|Confidence interval (CI) used Greenwood's formula for the standard error of a survival estimate|A hazard ratio (HR) \<1 favours AZD6244 75 mg bd+Docetaxel|||0.78|0.37|0.0158
74001486|NCT01749904|147551572|NON_INFERIORITY|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs \<1.5 mmHg at all time points of each visit and \<1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI\<0 mmHg at all time points of each visit.|||||<|0.01||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol and also superiority of BOL-303259-X to timolol|ANCOVA|||||||<0.01
74001487|NCT01749904|147551573|OTHER|||||||0.005|||||||Chi-squared|||||||0.005
74001488|NCT01749904|147551574|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
73877724|NCT03649217|147295309|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||.0001
73877725|NCT03649217|147295310|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||.0001
73877726|NCT03649217|147295311|SUPERIORITY|||||||0.001|||||||ANOVA|||||||.001
73877727|NCT03649217|147295312|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||.0002
73877728|NCT03649217|147295313|SUPERIORITY|||||||0.006|||||||ANOVA|||||||.006
73877729|NCT01506271|147295316|NON_INFERIORITY|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|1.1|||<|0.001|TWO_SIDED|95.0|-6.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|MK-7655 250 mg - Placebo: Percentage Difference||8.6|-6.2|< 0.001
73877730|NCT01506271|147295316|NON_INFERIORITY|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|3.7|||<|0.001|TWO_SIDED|95.0|-2.0|10.8|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||10.8|-2.0|< 0.001
73877731|NCT01506271|147295317|OTHER|Test for a non-zero difference.|Percentage Difference|0.0||||0.979|TWO_SIDED|95.0|-4.7|4.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||4.5|-4.7|0.979
74001489|NCT01749904|147551575|OTHER||||||||||||||||||No statistical analysis was performed on these proportions.|||
73877732|NCT01506271|147295317|OTHER|Test for a non-zero difference.|Percentage Difference|-1.8||||0.153|TWO_SIDED|95.0|-6.2|1.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||1.5|-6.2|0.153
73877733|NCT01506271|147295318|OTHER|Test for a non-zero difference.|Percentage Difference|0.9||||0.324|TWO_SIDED|95.0|-2.4|4.7|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||4.7|-2.4|0.324
73877734|NCT01506271|147295318|OTHER|Test for a non-zero difference|Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.3|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||3.2|-3.3|> 0.999
73877735|NCT01506271|147295319|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|7.5|||||TWO_SIDED|95.0|-5.4|20.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||20.1|-5.4|
73877736|NCT01506271|147295319|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|6.2|||||TWO_SIDED|95.0|-6.7|18.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||18.8|-6.7|
73877737|NCT01506271|147295320|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||TWO_SIDED|95.0|-10.3|2.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||2.4|-10.3|
74001490|NCT01383499|147551607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.023||0.0002|TWO_SIDED|95.0|0.042|0.132||First step of closed testing procedure, where the active treatments are compared to placebo. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R5 minus Placebo||0.132|0.042|0.0002
74037027|NCT04593940|147627263|SUPERIORITY||Odds Ratio (OR)|1.287||||0.4132|TWO_SIDED|95.0|0.703|2.355|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||2.355|0.703|0.4132
74001491|NCT01383499|147551607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.059|0.149||Second step of closed testing procedure. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R2.5 minus Placebo||0.149|0.059|<.0001
74001492|NCT01383499|147551607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.023||0.0011|TWO_SIDED|95.0|0.03|0.12|||Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo||0.120|0.030|0.0011
74001493|NCT01383499|147551607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.034|0.057|||Mixed model repeated measures (MMRM)|||Tio R5 minus Tio R1.25||0.057|-0.034|
74001494|NCT01383499|147551607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.063|0.028|||Mixed model repeated measures (MMRM)|||Tio R5 minus Tio R2.5||0.028|-0.063|
74001495|NCT01383499|147551607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.016|0.074|||Mixed models repeated measures (MMRM)|||Tio R2.5 minus Tio R1.25||0.074|-0.016|
74001496|NCT01079663|147551643|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.1629|TWO_SIDED|95.0|-1.19|0.2|||Mixed Models Analysis|||||0.20|-1.19|0.1629
74001497|NCT01079663|147551644|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.0347|TWO_SIDED|95.0|-1.46|-0.06|||Mixed Models Analysis|||||-0.06|-1.46|0.0347
74001498|NCT00946101|147551649|NON_INFERIORITY_OR_EQUIVALENCE|For the calculation of the power to rule out a 10% increase of fever rate in vaccine recipients with 300 evaluable subjects (240 vaccine and 60 placebo recipients), it is assumed that the true fever rate in the monovalent vaccine group is 3.0% to 8.0%,and the true fever rate in placebo group is 0% to 3% lower than the fever rate in the vaccine group.|rate difference|0.0|||||TWO_SIDED|95.0|-6.4|3.1|||score|||The rate of subjects with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the pre-specified equivalence criterion of 10% which corresponds to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference \< 10%||3.1|-6.4|
74001499|NCT00946101|147551650|SUPERIORITY_OR_OTHER||rate difference|1.5|||||TWO_SIDED|95.0|-12.8|9.8|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||9.8|-12.8|
73877738|NCT01506271|147295320|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||TWO_SIDED|95.0|-5.0|10.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||10.1|-5.0|
73877739|NCT01506271|147295321|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.0|||||TWO_SIDED|95.0|-4.5|12.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||12.7|-4.5|
74001500|NCT00946101|147551651|SUPERIORITY_OR_OTHER||rate difference|4.9|||||TWO_SIDED|95.0|-9.6|13.8|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||13.8|-9.6|
74001501|NCT00946101|147551652|SUPERIORITY_OR_OTHER||rate difference|17.5|||||TWO_SIDED|95.0|5.5|27.1|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||27.1|5.5|
74001502|NCT00946101|147551653|SUPERIORITY_OR_OTHER||rate difference|5.1|||||TWO_SIDED|95.0|-8.4|17.6|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compated following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||17.6|-8.4|
74001503|NCT00946101|147551656|SUPERIORITY_OR_OTHER||rate difference|13.3|||||TWO_SIDED|95.0|-0.4|25.7|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||25.7|-0.4|
74008765|NCT02632721|147567640|OTHER||Probability of DLT rate in [0.16, 0.33)|0.012|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
74001504|NCT00946101|147551659|SUPERIORITY_OR_OTHER||rate difference|-6.3|||||TWO_SIDED|95.0|-19.7|6.1|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||6.1|-19.7|
74037028|NCT04593940|147627264|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.1601|TWO_SIDED|95.0|1.0|1.28|||Fine-Gray Proportional Hazards Model|||||1.28|1.00|0.1601
74037029|NCT04593940|147627264|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.355|TWO_SIDED|95.0|0.97|1.24|||Fine-Gray Proportional Hazards Model|||||1.24|0.97|0.3550
74037030|NCT04593940|147627264|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2386|TWO_SIDED|95.0|0.8|1.07|||Fine-Gray Proportional Hazards Model|||||1.07|0.80|0.2386
74037031|NCT04593940|147627265|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.1519|TWO_SIDED|95.0|0.98|1.26|||Fine-Gray Proportional Hazards Model|||||1.26|0.98|0.1519
74037032|NCT04593940|147627265|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.2605|TWO_SIDED|95.0|0.98|1.26|||Fine-Gray Proportional Hazards Model|||||1.26|0.98|0.2605
74037033|NCT04593940|147627265|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.4359|TWO_SIDED|95.0|0.83|1.13|||Fine-Gray Proportional Hazards Model|||||1.13|0.83|0.4359
74037034|NCT04593940|147627266|SUPERIORITY||Mean Difference (Net)|-0.06||||0.321|TWO_SIDED|95.0|-0.18|0.06|||t-test, 2 sided|||||0.06|-0.18|0.3210
74037035|NCT04593940|147627266|SUPERIORITY||Mean Difference (Net)|0.04||||0.5275|TWO_SIDED|95.0|-0.09|0.17|||t-test, 2 sided|||||0.17|-0.09|0.5275
74037036|NCT04593940|147627266|SUPERIORITY||Mean Difference (Net)|0.0||||0.9993|TWO_SIDED|95.0|-0.15|0.15|||t-test, 2 sided|||||0.15|-0.15|0.9993
74037037|NCT04593940|147627267|SUPERIORITY||Mean Difference (Net)|0.07||||0.4982|TWO_SIDED|95.0|-0.13|0.26|||t-test, 2 sided|||||0.26|-0.13|0.4982
74037038|NCT04593940|147627267|SUPERIORITY||Mean Difference (Net)|0.09||||0.3491|TWO_SIDED|95.0|-0.1|0.29|||t-test, 2 sided|||||0.29|-0.10|0.3491
74037039|NCT04593940|147627267|SUPERIORITY||Mean Difference (Net)|-0.01||||0.902|TWO_SIDED|95.0|-0.25|0.22|||t-test, 2 sided|||||0.22|-0.25|0.9020
74037040|NCT04593940|147627268|SUPERIORITY||Mean Difference (Net)|0.24||||0.0842|TWO_SIDED|95.0|-0.03|0.52|||t-test, 2 sided|||||0.52|-0.03|0.0842
74037041|NCT04593940|147627268|SUPERIORITY||Mean Difference (Net)|0.09||||0.5328|TWO_SIDED|95.0|-0.19|0.37|||t-test, 2 sided|||||0.37|-0.19|0.5328
74001505|NCT00946101|147551662|SUPERIORITY_OR_OTHER||rate difference|-6.4|||||TWO_SIDED|95.0|-20.3|7.1|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||7.1|-20.3|
74037042|NCT04593940|147627268|SUPERIORITY||Mean Difference (Net)|-0.12||||0.4727|TWO_SIDED|95.0|-0.46|0.21|||t-test, 2 sided|||||0.21|-0.46|0.4727
74037043|NCT04593940|147627269|SUPERIORITY||Mean Difference (Net)|0.31||||0.0399|TWO_SIDED|95.0|0.01|0.61|||t-test, 2 sided|||||0.61|0.01|0.0399
74037044|NCT04593940|147627269|SUPERIORITY||Mean Difference (Net)|0.11||||0.4515|TWO_SIDED|95.0|-0.18|0.41|||t-test, 2 sided|||||0.41|-0.18|0.4515
74037045|NCT04593940|147627269|SUPERIORITY||Mean Difference (Net)|-0.07||||0.696|TWO_SIDED|95.0|-0.43|0.29|||t-test, 2 sided|||||0.29|-0.43|0.6960
74037046|NCT04593940|147627270|SUPERIORITY||Mean Difference (Net)|0.26||||0.0903|TWO_SIDED|95.0|-0.04|0.57|||t-test, 2 sided|||||0.57|-0.04|0.0903
74037047|NCT04593940|147627270|SUPERIORITY||Mean Difference (Net)|0.15||||0.348|TWO_SIDED|95.0|-0.16|0.45|||t-test, 2 sided|||||0.45|-0.16|0.3480
74037048|NCT04593940|147627270|SUPERIORITY||Mean Difference (Net)|-0.07||||0.6984|TWO_SIDED|95.0|-0.44|0.29|||t-test, 2 sided|||||0.29|-0.44|0.6984
74037049|NCT04593940|147627271|SUPERIORITY||Mean Difference (Net)|0.32||||0.045|TWO_SIDED|95.0|0.01|0.62|||t-test, 2 sided|||||0.62|0.01|0.0450
74037050|NCT04593940|147627271|SUPERIORITY||Mean Difference (Net)|0.19||||0.2462|TWO_SIDED|95.0|-0.13|0.5|||t-test, 2 sided|||||0.50|-0.13|0.2462
74037051|NCT04593940|147627271|SUPERIORITY||Mean Difference (Net)|-0.23||||0.2304|TWO_SIDED|95.0|-0.61|0.15|||t-test, 2 sided|||||0.15|-0.61|0.2304
74037052|NCT04593940|147627272|SUPERIORITY||Mean Difference (Net)|0.35||||0.0313|TWO_SIDED|95.0|0.03|0.66|||t-test, 2 sided|||||0.66|0.03|0.0313
74037053|NCT04593940|147627272|SUPERIORITY||Mean Difference (Net)|0.31||||0.0555|TWO_SIDED|95.0|-0.01|0.63|||t-test, 2 sided|||||0.63|-0.01|0.0555
74037054|NCT04593940|147627272|SUPERIORITY||Mean Difference (Net)|-0.22||||0.271|TWO_SIDED|95.0|-0.6|0.17|||t-test, 2 sided|||||0.17|-0.60|0.2710
74037055|NCT04593940|147627273|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.0|2.0||||||||2.0|-0.0|
74037056|NCT04593940|147627273|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.5|1.6||||||||1.6|-0.5|
74037057|NCT04593940|147627273|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.8|0.7||||||||0.7|-1.8|
74037058|NCT04593940|147627274|SUPERIORITY||Difference in percentages|29.2|||||TWO_SIDED|95.0|-0.4|53.7||||||||53.7|-0.4|
74037059|NCT04593940|147627274|SUPERIORITY||Difference in percentages|14.0|||||TWO_SIDED|95.0|-14.8|40.0||||||||40.0|-14.8|
74037060|NCT04593940|147627274|SUPERIORITY||Difference in percentages|-5.8|||||TWO_SIDED|95.0|-38.7|26.6||||||||26.6|-38.7|
74037061|NCT04593940|147627275|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|0.2|2.3||||||||2.3|0.2|
74037062|NCT04593940|147627275|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-0.1|2.0||||||||2.0|-0.1|
74037063|NCT04593940|147627275|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-2.0|0.6||||||||0.6|-2.0|
74037064|NCT04593940|147627276|SUPERIORITY||Difference in percentages|-7.0|||||TWO_SIDED|95.0|-14.0|0.0||||||||0.0|-14.0|
74037065|NCT04593940|147627276|SUPERIORITY||Difference in percentages|-3.9|||||TWO_SIDED|95.0|-11.1|3.4||||||||3.4|-11.1|
73877740|NCT01506271|147295321|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-4.4|12.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||12.8|-4.4|
73877741|NCT01506271|147295322|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||TWO_SIDED|95.0|-4.0|3.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||3.9|-4.0|
73877742|NCT01506271|147295322|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-4.8|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||2.4|-4.8|
73877743|NCT01506271|147295323|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-6.7|2.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||2.3|-6.7|
73877744|NCT01506271|147295323|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||7.4|-3.7|
73877745|NCT01506271|147295324|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.6|||||TWO_SIDED|95.0|-7.5|0.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||0.6|-7.5|
73877746|NCT01506271|147295324|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-6.7|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||2.4|-6.7|
73877747|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-4.7|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Diarrhoea||8.1|-4.7|
73877748|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-4.6|8.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Diarrhoea||8.2|-4.6|
74037066|NCT04593940|147627276|SUPERIORITY||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-10.1|8.1||||||||8.1|-10.1|
74037067|NCT04593940|147627277|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-0.1|1.8||||||||1.8|-0.1|
74037068|NCT04593940|147627277|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-0.3|1.7||||||||1.7|-0.3|
74037069|NCT04593940|147627277|SUPERIORITY||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-2.0|0.4||||||||0.4|-2.0|
74037070|NCT04593940|147627278|SUPERIORITY||Difference in percentages|-1.1|||||TWO_SIDED|95.0|-5.7|3.5||||||||3.5|-5.7|
74037071|NCT04593940|147627278|SUPERIORITY||Difference in percentages|-1.3|||||TWO_SIDED|95.0|-6.0|3.3||||||||3.3|-6.0|
74037072|NCT04593940|147627278|SUPERIORITY||Difference in percentages|2.2|||||TWO_SIDED|95.0|-3.7|8.0||||||||8.0|-3.7|
74037073|NCT04593940|147627279|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.0|2.0||||||||2.0|-0.0|
73877749|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-7.3|6.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nausea||6.9|-7.3|
73877750|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||TWO_SIDED|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nausea||8.0|-6.5|
74037074|NCT04593940|147627279|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.7|1.4||||||||1.4|-0.7|
74037075|NCT04593940|147627279|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.3|1.1||||||||1.1|-1.3|
74037076|NCT04593940|147627280|SUPERIORITY||Hazard Ratio (HR)|0.878||||0.3169|TWO_SIDED|95.0|0.68|1.133|||Log Rank|||||1.133|0.680|0.3169
74037077|NCT04593940|147627280|SUPERIORITY||Hazard Ratio (HR)|0.863||||0.248|TWO_SIDED|95.0|0.672|1.108|||Log Rank|||||1.108|0.672|0.2480
74037078|NCT04593940|147627280|SUPERIORITY||Hazard Ratio (HR)|1.191||||0.249|TWO_SIDED|95.0|0.885|1.604|||Log Rank|||||1.604|0.885|0.2490
74037079|NCT04593940|147627281|SUPERIORITY||Hazard Ratio (HR)|1.083||||0.5175|TWO_SIDED|95.0|0.85|1.38|||Log Rank|||||1.380|0.850|0.5175
74037080|NCT04593940|147627281|SUPERIORITY||Hazard Ratio (HR)|0.923||||0.5216|TWO_SIDED|95.0|0.722|1.179|||Log Rank|||||1.179|0.722|0.5216
74037081|NCT04593940|147627281|SUPERIORITY||Hazard Ratio (HR)|1.075||||0.6135|TWO_SIDED|95.0|0.812|1.424|||Log Rank|||||1.424|0.812|0.6135
74037082|NCT04593940|147627282|SUPERIORITY||Hazard Ratio (HR)|0.565||||0.3628|TWO_SIDED|95.0|0.165|1.931|||Log Rank|||||1.931|0.165|0.3628
73877751|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|3.4|||||TWO_SIDED|95.0|-2.3|9.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vomiting||9.6|-2.3|
74001506|NCT00946101|147551671|SUPERIORITY_OR_OTHER||rate difference|7.0|||||TWO_SIDED|95.0|-6.1|14.7|||score|||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||14.7|-6.1|
74001507|NCT00946101|147551672|SUPERIORITY_OR_OTHER||rate difference|7.2|||||TWO_SIDED|95.0|-5.8|15.1|||score|||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||15.1|-5.8|
74001508|NCT00946101|147551673|SUPERIORITY_OR_OTHER||rate difference|16.7|||||TWO_SIDED|95.0|5.9|25.2|||score|||The number of subjects who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||25.2|5.9|
74001509|NCT02318992|147551706|OTHER|||||||0.157|||||||Chi-squared, Corrected|||||||0.157
74001510|NCT02318992|147551707|OTHER|||||||0.041|||||||Chi-squared, Corrected|||||||0.041
74001511|NCT00552240|147551708|NON_INFERIORITY_OR_EQUIVALENCE|A point estimate of -6.5% or higher for the diff. in the prop. of responders (NVP - ATV/r) was to be considered consistent with a successful ArTEN study. In the worst case for both studies, if the 2 studies were to be pooled, the non-inferiority margin of -12% would then be outside the 95% confidence interval (CI).|Difference in proportion of responders|-0.041||||0.7142||95.0|-0.183|0.101|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||With 75 evaluable patients per treatment group, this study had 80% power to observe a difference no lower than -6.5% assuming the true proportions of responders are both 65%.||0.101|-0.183|0.7142
74001512|NCT00552240|147551709|NON_INFERIORITY_OR_EQUIVALENCE|Same as for the primary analysis|Difference in proportion of responders|-0.027||||0.6479||95.0|-0.167|0.113|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.113|-0.167|0.6479
74001513|NCT00552240|147551710|NON_INFERIORITY_OR_EQUIVALENCE|Same as for primary analysis|Difference in proportion of responders|0.084||||0.1477||95.0|-0.03|0.197|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.197|-0.030|0.1477
74001514|NCT00552240|147551711|NON_INFERIORITY_OR_EQUIVALENCE|Same as for primary analysis|Difference in proportion of responders|-0.067||||0.3703||95.0|-0.215|0.08|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.080|-0.215|0.3703
74001515|NCT00552240|147551712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.0314||95.0|0.46|0.964|||Regression, Cox|Controlling for screening viral load and CD4+ categories.||Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine.||0.964|0.460|0.0314
73877752|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.1|||||TWO_SIDED|95.0|-0.7|11.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vomiting||11.8|-0.7|
73877753|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.6|3.5|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Postoperative Infection||3.5|-7.6|
73877754|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Postoperative Infection||2.2|-8.4|
74001516|NCT00552240|147551713|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.628||||0.0172||95.0|0.428|0.921|||Regression, Cox|Controlling for screening viral load and CD4+ categories||"Responders only~Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine."||0.921|0.428|0.0172
74001517|NCT00552240|147551741|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.8||||0.7315||95.0|-8.4|11.9|||ANCOVA|Controlling for screening viral load and CD4+ categories||||11.9|-8.4|0.7315
74001518|NCT00552240|147551742|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.6||||0.3625||95.0|-33.4|12.3|||ANCOVA|Controlling for screening viral load and CD4+ categories||||12.3|-33.4|0.3625
74001519|NCT00552240|147551743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.0164||95.0|0.9|8.8|||ANCOVA|Controlling for screening viral load and CD4+ categories||||8.8|0.9|0.0164
74001520|NCT00552240|147551744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.9257||95.0|-8.4|9.3|||ANCOVA|Controlling for screening viral load and CD4+ categories||||9.3|-8.4|0.9257
74001521|NCT00552240|147551745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0375||95.0|-0.64|-0.02|||ANCOVA|Controlling for screening viral load and CD4+ categories||||-0.02|-0.64|0.0375
74001522|NCT00552240|147551746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.4645||95.0|-1.02|0.47|||ANCOVA|Controlling for screening viral load and CD4+ categories||||0.47|-1.02|0.4645
74008766|NCT02632721|147567640|OTHER||Probability of DLT rate in [0.33, 1)|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
74008767|NCT04166383|147567659|OTHER|||||||0.1||||||P≤0.10 (alpha 0.1); power = 90% (beta 0.1)|Kaplan-Meier|||||||0.10
74008768|NCT03346057|147567664|OTHER||Estimated Difference in percentage|-6.7||||0.026|TWO_SIDED|95.0|-17.5|-0.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by neuromuscular blocking agent (NMBA) and American Society of Anesthesiologists (ASA) class was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-0.8|-17.5|0.026
73877755|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.9|||||TWO_SIDED|95.0|-2.4|4.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Seroma||4.7|-2.4|
74001523|NCT02783768|147551760|OTHER|Testing for difference in the outcome measure according to the exposure (which was not a treatment) in a randomized crossover setting.|Mean Difference (Net)|13.98||||0.012|TWO_SIDED|95.0|4.012|23.94|||Mixed Models Analysis||Measurements were included for participants with at least one valid MRI measurement.|"Within-person effects of e-cigarette exposure on pulmonary microvascular blood flow (PMBF) was assessed via mixed models accounting for order effects.~Null hypothesis: e-cigarette exposure is NOT associated with a change in PMBF.~Alternative hypothesis: e-cigarette exposure IS associated with a change in PMBF.~Power calculation: not applicable since this was a pilot/feasibility study."||23.94|4.012|0.012
74001524|NCT02476279|147551767|NON_INFERIORITY|To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.|Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|0.006|0.066|||||These numbers are in the intention-to-treat analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.|||0.066|0.006|
74001525|NCT02476279|147551767|NON_INFERIORITY|To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.|Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.003|0.06|||||These numbers are in the per protocol analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.|||0.060|-0.003|
74001526|NCT02476279|147551768|OTHER||Risk Difference (RD)|0.021|||||TWO_SIDED|95.0|-0.002|0.043|||||These numbers are in the intention-to-treat analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.|||0.043|-0.002|
74001527|NCT02476279|147551768|OTHER||Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.004|0.044|||||These numbers are in the per protocol analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.|||0.044|-0.004|
74001528|NCT02054741|147551791|SUPERIORITY||Risk Ratio (RR)|0.74||||0.0001|TWO_SIDED|95.0|0.64|0.86|||Mixed Models Analysis|Generalized Linear Mixed Model||||0.86|0.64|0.0001
74001529|NCT02054741|147551792|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.39|TWO_SIDED|95.0|0.85|1.5|||Regression, Cox|||||1.50|0.85|0.39
74001530|NCT02054741|147551793|SUPERIORITY||Risk Ratio (RR)|1.38||||0.015|TWO_SIDED|95.0|1.06|1.78|||Mixed Models Analysis|Generalized Linear Mixed Model||||1.78|1.06|0.015
74001531|NCT02319525|147551813|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 2 sided|||||||0.005
74001532|NCT02319525|147551814|SUPERIORITY_OR_OTHER|||||||0.08||||||We compared informed choice vs. no informed choice made between the decision aid and the pamphlet groups.|Chi-squared|||||||0.08
73877756|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.3|||||TWO_SIDED|95.0|1.0|9.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Seroma||9.7|1.0|
74001533|NCT02319525|147551815|SUPERIORITY_OR_OTHER|||||||0.252|||||||Chi-squared|||We compared concordance between preferred and actual roles vs. no concordance between roles between decision aid and pamphlet.||||0.252
74001534|NCT02319525|147551816|SUPERIORITY_OR_OTHER|||||||0.504|||||||t-test, 2 sided|||||||0.504
74001535|NCT02319525|147551817|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
74001536|NCT02319525|147551818|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Impact of lupus nephritis"||||0.006
74001537|NCT02319525|147551818|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Risk factors"||||0.006
74001538|NCT02319525|147551818|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the medication options"||||0.003
74001539|NCT02319525|147551818|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the evidence about medications"||||<0.001
74001540|NCT02319525|147551818|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the study about other patients"||||<0.001
74001541|NCT02319525|147551819|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||The test of significance compared all the rows, i.e., all response options for the statement.||||0.006
74001542|NCT01856868|147551887|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0434|||||||t-test, 2 sided|||||||0.0434
74001543|NCT01856868|147551888|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0185|||||||t-test, 2 sided|||||||0.0185
74001544|NCT01856868|147551889|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0434|||||||t-test, 2 sided|||||||0.0434
74001545|NCT01856868|147551890|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0078|||||||t-test, 2 sided|||||||0.0078
74001546|NCT01856868|147551891|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0025|||||||t-test, 2 sided|||||||0.0025
74001547|NCT01856868|147551892|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0082|||||||t-test, 2 sided|||||||0.0082
74001548|NCT01856868|147551893|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.031|||||||t-test, 2 sided|||||||0.031
74001549|NCT01856868|147551894|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0238|||||||Wilcoxon (Mann-Whitney)|||||||0.0238
74001550|NCT01856868|147551895|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0321|||||||t-test, 2 sided|||||||0.0321
73877757|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-5.0|6.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - ALT increased||6.6|-5.0|
73877758|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-4.9|6.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - ALT increased||6.7|-4.9|
73877759|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-3.7|7.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - AST increased||7.3|-3.7|
73877760|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - AST increased||7.4|-3.7|
74090848|NCT00899470|147735869|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio Test vs. Reference|1.022|||||TWO_SIDED|95.0|0.985|1.06|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(INF)\] of saxagliptin and metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.060|0.985|
74090849|NCT00899470|147735871|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted and fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin, respectively.|Geometric Mean Ratio, Test vs. Reference|1.009|||||TWO_SIDED|90.0|0.939|1.084|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.084|0.939|
74090850|NCT00899470|147735871|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin.|Geometric Mean Ratio, Test vs. Reference|1.034|||||TWO_SIDED|90.0|0.962|1.111|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.111|0.962|
74090851|NCT00899470|147735872|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.024|||||TWO_SIDED|90.0|0.964|1.088|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of metformin the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(0-T)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.964|
74090852|NCT00899470|147735872|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||TWO_SIDED|90.0|0.981|1.108|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(0-T)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.108|0.981|
74091726|NCT05472662|147737053|OTHER||Adjusted mean difference|-0.011||||0.632|TWO_SIDED|95.0|-0.058|0.036|||ANCOVA|||"Statistical analysis performed on the data at 1 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.036|-0.058|0.632
73877761|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.5|4.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Lipase increased||4.2|-6.5|
74001551|NCT01856868|147551896|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0182|||||||t-test, 2 sided|||||||0.0182
74001552|NCT01856868|147551897|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0371|||||||t-test, 2 sided|||||||0.0371
74001553|NCT01856868|147551898|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0257|||||||t-test, 2 sided|||||||0.0257
74001554|NCT01856868|147551901|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height and weight using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|-1.82|STANDARD_ERROR_OF_MEAN|2.51||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
74037083|NCT04593940|147627282|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.3701|TWO_SIDED|95.0|0.167|1.948|||Log Rank|||||1.948|0.167|0.3701
74037084|NCT04593940|147627282|SUPERIORITY||Hazard Ratio (HR)|4.988||||0.0001|TWO_SIDED|95.0|2.211|11.251|||Log Rank|||||11.251|2.211|0.0001
73877762|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Lipase increased||3.0|-7.2|
73877763|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.5|||||TWO_SIDED|95.0|-8.7|-0.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Hypertension||-0.3|-8.7|
73877764|NCT01506271|147295325|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.4|4.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Hypertension||4.3|-6.4|
74001555|NCT01856868|147551902|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|11.2|STANDARD_ERROR_OF_MEAN|16.6||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
74001556|NCT01856868|147551904|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|5.33|STANDARD_ERROR_OF_MEAN|3.79||0.159|TWO_SIDED||||||Mixed Models Analysis|||||||0.159
74001557|NCT00968227|147551905|SUPERIORITY|Paired t-test||||||0.001|||||||t-test, 2 sided|||||||0.001
74037085|NCT00753935|147627318|SUPERIORITY|||||||0.005|||||||Wilcoxon rank-sum|||||||0.005
74037086|NCT03970395|147627319|SUPERIORITY||Risk Ratio (RR)|7.66||||0.01|TWO_SIDED|95.0|2.46|23.84||The threshold for statistical significance was p\<0.5|Risk Ratio (RR)||Risk Difference 0.41 (IC 95; 0.25-0.53)|||23.84|2.46|0.01
74037087|NCT03970395|147627320|SUPERIORITY||Risk Ratio (RR)|5.6||||0.01|TWO_SIDED|95.0|2.36|13.27|||Relative Risk (RR)||Risk Difference 0.47 (IC 95; 0.31-0.64)|||13.27|2.36|0.01
74037088|NCT03970395|147627321|SUPERIORITY||Risk Ratio (RR)|7.49||||0.01|TWO_SIDED|95.0|2.42|23.18|||Risk Ratio (RR)||Risk Difference 0.44 (IC 95%; 0.27-0.60)|||23.18|2.42|0.01
74001558|NCT03386110|147551922|SUPERIORITY||Risk Ratio, log|1.19||||0.08|TWO_SIDED|95.0|-0.15|2.54|||Mixed Models Analysis|Model testing whether condition predicted illicit drug use at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-month follow-up, and controlled for the nesting of participants within couples.||2.54|-0.15|0.08
74037089|NCT03970395|147627322|SUPERIORITY||Risk Ratio (RR)|4.91||||0.01|TWO_SIDED|95.0|2.12|11.38|||Risk Ratio (RR)||Risk Difference 0.54 (IC 95; 0.36-0.72)|||11.38|2.12|0.01
74037090|NCT00929734|147627335|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED||||||ANCOVA|||||||0.292
74037091|NCT00929734|147627336|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||ANCOVA|||||||0.462
74037092|NCT00929734|147627337|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||ANCOVA with natural logarithm of hs-CRP (ln hs-CRP)|ANCOVA|||||||0.017
74037093|NCT00929734|147627338|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||ANCOVA with natural logarithm of interleukin 6 (ln IL6)|ANCOVA|||||||0.028
74037094|NCT00980980|147627346|SUPERIORITY_OR_OTHER|||||||0.01|||||||Proportional-hazards models|Proportional-hazards models with shared frailties accounted for clustering within hospitals.||||||0.01
74037095|NCT03282357|147627371|NON_INFERIORITY|Non-inferiority margin, delta = 10 percent (%). The two-sided 95% confidence interval (CI) for the differences between percentages was constructed using the Newcombe's recommended method.|Difference in Percentage|-6.8|||||TWO_SIDED|95.0|-13.1|-0.5||||||||-0.5|-13.1|
74037096|NCT03282357|147627372|NON_INFERIORITY|Non-inferiority margin, delta = 15%. The two-sided 95% CI for the differences between percentages was constructed using the Newcombe's recommended method.|Difference in Percentage|-4.9|||||TWO_SIDED|95.0|-9.8|-0.3||||||||-0.3|-9.8|
74037097|NCT01586156|147627373|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
74037098|NCT01586156|147627374|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
74037099|NCT01586156|147627375|OTHER|Pearson's correlation test of association of alprenolol binding changes to dose carvedilol.||||||0.02||||||Correlation of the change in alprenolol binding relative to dose carvedilol.|Pearson|||||||0.02
74037100|NCT01586156|147627376|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
74037101|NCT01586156|147627378|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74037102|NCT01586156|147627379|NON_INFERIORITY|Carvedilol did not lead to worse cardiac output as compared to placebo.||||||0.8|||||||ANOVA|||||||0.8
74037103|NCT00547378|147627380|SUPERIORITY|||||||0.016|||||||Cochran-Mantel-Haenszel|The two-sided Cochran-Mantel-Haenszel (CMH) test, stratified for center, was used to test the difference in responder rates between the 2 groups||||||0.016
74037104|NCT00414960|147627384|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.04||0.556|TWO_SIDED|95.0|-10.64|5.83||P-value is for comparison of change from baseline between enzastaurin and placebo group.|2-sample pooled t-test||Using placebo as a reference group, the mean difference = enzastaurin minus placebo.|||5.83|-10.64|0.556
73877765|NCT01506271|147295326|SUPERIORITY||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||0|0|> 0.999
73877766|NCT01506271|147295326|SUPERIORITY||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||0|0|> 0.999
73877767|NCT01506271|147295327|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.4||||0.001|TWO_SIDED|95.0|-9.1|6.0|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.0|-9.1|0.001
73877768|NCT01506271|147295327|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-2.1||||0.002|TWO_SIDED|95.0|-9.7|5.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||5.3|-9.7|0.002
73877769|NCT01506271|147295328|NON_INFERIORITY|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-6.3|6.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.2|-6.3|< 0.001
73877770|NCT01506271|147295328|NON_INFERIORITY|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|2.4|||<|0.001|TWO_SIDED|95.0|-2.0|8.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.3|-2.0|< 0.001
73877771|NCT01506271|147295329|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-6.7|6.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.4|-6.7|< 0.001
73877772|NCT01506271|147295329|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.1|||<|0.001|TWO_SIDED|95.0|-6.3|6.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||6.5|-6.3|< 0.001
73877773|NCT01506271|147295330|NON_INFERIORITY|Non-inferiority test based on Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.3||||0.002|TWO_SIDED|95.0|-9.6|6.9|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.9|-9.6|0.002
74001559|NCT03386110|147551922|SUPERIORITY||Risk Ratio, log|0.7||||0.25|TWO_SIDED|95.0|-0.49|1.89|||Mixed Models Analysis|Model testing whether condition predicted illicit drug use at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||1.89|-0.49|0.25
74001560|NCT03386110|147551922|SUPERIORITY||Risk Ratio, log|1.79||||0.007|TWO_SIDED|95.0|0.49|3.09|||Mixed Models Analysis|Three-way interaction model testing whether baseline use (actor and partner) moderated the effect of condition on illicit drug use at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||3.09|0.49|0.007
74001561|NCT03386110|147551922|SUPERIORITY||Risk Ratio, log|-0.36||||0.71|TWO_SIDED|95.0|-2.26|1.53|||Mixed Models Analysis|Three-way interaction model testing whether baseline use (actor and partner) moderated the effect of condition on illicit drug use at 6-months||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||1.53|-2.26|0.71
74001562|NCT03386110|147551923|SUPERIORITY||Risk Ratio, log|0.36||||0.36|TWO_SIDED|95.0|-0.65|1.37|||Mixed Models Analysis|Model testing whether condition predicted CAS events at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.||1.37|-0.65|0.36
74001563|NCT03386110|147551923|SUPERIORITY||Risk Ratio, log|-0.18||||0.63|TWO_SIDED|95.0|-1.15|0.78|||Mixed Models Analysis|Model testing whether condition predicted CAS events at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||0.78|-1.15|0.63
74001564|NCT03386110|147551923|SUPERIORITY||Risk Ratio, log|-0.54||||0.42|TWO_SIDED|95.0|-1.85|0.77|||Mixed Models Analysis|Three-way interaction model testing whether baseline rates of CAS (actor and partner) moderated the effect of condition on CAS events at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.77|-1.85|0.42
74001565|NCT03386110|147551923|SUPERIORITY||Risk Ratio, log|-1.7||||0.02|TWO_SIDED|95.0|-3.14|-0.27|||Mixed Models Analysis|Three-way interaction model testing whether baseline rates of CAS (actor and partner) moderated the effect of condition on CAS events at 6-months||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||-0.27|-3.14|0.02
74001566|NCT03386110|147551924|SUPERIORITY||Risk Ratio, log|0.48||||0.15|TWO_SIDED|95.0|-0.18|1.44|||Mixed Models Analysis|Model testing whether condition predicted marijuana use at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.||1.44|-0.18|0.15
74001567|NCT03386110|147551924|SUPERIORITY||Risk Ratio, log|0.24||||0.5|TWO_SIDED|95.0|-0.44|0.92|||Mixed Models Analysis|Model testing whether condition predicted marijuana use at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||0.92|-0.44|0.50
73877774|NCT01506271|147295330|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|0.4|||<|0.001|TWO_SIDED|95.0|-7.2|8.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.2|-7.2|< 0.001
73957211|NCT04771273|147450407|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.2204|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.2204
73957212|NCT04771273|147450407|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957213|NCT04771273|147450407|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957214|NCT04771273|147450407|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957215|NCT04771273|147450408|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|5.07|||<|0.0001|TWO_SIDED|95.0|2.47|10.4||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||10.40|2.47|<.0001
73957216|NCT04771273|147450408|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|9.46|||<|0.0001|TWO_SIDED|95.0|4.36|20.51||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||20.51|4.36|<.0001
73957217|NCT04771273|147450408|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|16.09|||<|0.0001|TWO_SIDED|95.0|6.69|38.73||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||38.73|6.69|<.0001
74008769|NCT03346057|147567664|OTHER||Estimated Difference in percentage|-6.2||||0.058|TWO_SIDED|95.0|-17.3|0.2|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||0.2|-17.3|0.058
74037105|NCT04105244|147627386|SUPERIORITY||Wald tests|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
74037106|NCT04105244|147627387|SUPERIORITY||Wald tests|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
74091727|NCT05472662|147737053|OTHER||Adjusted mean difference|-0.003||||0.846|TWO_SIDED|95.0|-0.038|0.031|||ANCOVA|||"Statistical analysis performed on the data at 1.5 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.031|-0.038|0.846
73877775|NCT01506271|147295331|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-7.4|7.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||7.4|-7.4|< 0.001
74037107|NCT04105244|147627388|SUPERIORITY||Wald test|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
74037108|NCT04105244|147627391|SUPERIORITY||Wald test|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
73877776|NCT01506271|147295331|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|1.4|||<|0.001|TWO_SIDED|95.0|-5.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.6|-5.2|< 0.001
74001568|NCT03386110|147551924|SUPERIORITY||Risk Ratio, log|-0.02||||0.91|TWO_SIDED|95.0|-0.34|0.31|||Mixed Models Analysis|Three-way interaction model testing whether baseline use moderated the effect of condition on marijuana use at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.31|-0.34|0.910
74001569|NCT03386110|147551924|SUPERIORITY||Risk Ratio, log|0.34||||0.11|TWO_SIDED|95.0|-0.07|0.75|||Mixed Models Analysis|||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.75|-0.07|0.11
74001570|NCT00943111|147551934|NON_INFERIORITY_OR_EQUIVALENCE|The sample size for study was based on expected stability rates of 95% for the Imiglucerase group and 85% for the Eliglustat group, power of 85%, a one-sided significance level of 0.025, a non-inferiority margin of 25%, and a 20% non-evaluable/drop-out rate. Eliglustat was declared non-inferior to Imiglucerase if the lower-bound of the 95% confidence interval for the difference was within the non-inferiority margin of 25%.|Difference in Percentage Stable|-8.8|||||TWO_SIDED|95.0|-17.6|4.2||||||||4.2|-17.6|
74001571|NCT04227704|147551980|SUPERIORITY|||||||0.09|||||||ANOVA|||||||0.09
74001572|NCT04227704|147551981|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
74001573|NCT04227704|147551988|SUPERIORITY|||||||0.44|||||||ANOVA|||||||0.44
74001574|NCT01775124|147552024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-2.95|-0.2|||ANOVA|||Descriptive, no hypothesis||-0.2|-2.95|
74001575|NCT00409773|147552040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-16.5|-9.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-9.8|-16.5|<0.001
74001576|NCT00409773|147552040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-13.6|-6.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.9|-13.6|<0.001
74001577|NCT00409773|147552040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-11.3|-4.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.6|-11.3|<0.001
74001578|NCT00409773|147552041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-9.6|-4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.8|-9.6|<0.001
74037109|NCT04105244|147627392|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74037110|NCT02768194|147627407|SUPERIORITY||Mean Difference (Net)|-0.11||||0.5512|TWO_SIDED|95.0|-0.46|0.25||From the MMRM model with change from pre-dose as response, participant as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.25|-0.46|0.5512
74037111|NCT02768194|147627407|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9671|TWO_SIDED|95.0|-0.36|0.35||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.35|-0.36|0.9671
74001579|NCT00409773|147552041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.8|-2.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.9|-7.8|<0.001
74001580|NCT00409773|147552041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.8|-2.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.0|-6.8|<0.001
74001581|NCT00409773|147552042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.69||95.0|-5.4|3.3|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||3.3|-5.4|0.690
74001582|NCT00409773|147552042|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.8||||0.2||95.0|-1.6|7.1|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||7.1|-1.6|0.200
74001583|NCT00409773|147552042|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.4||||0.48||95.0|-4.7|3.9|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||3.9|-4.7|0.480
74001584|NCT00409773|147552043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|1.3||0.013||95.0|0.7|6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||6.0|0.7|0.013
73877777|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Blood, lymphatic||5.1|-7.3|
73877778|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||TWO_SIDED|95.0|-10.3|0.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Blood, lymphatic||0.1|-10.3|
73877779|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-5.2|5.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Cardiac disorder||5.0|-5.2|
73877780|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-4.5|6.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Cardiac disorder||6.3|-4.5|
73877781|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.6|||||TWO_SIDED|95.0|-3.9|15.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - GI disorders||15.3|-3.9|
74001585|NCT00409773|147552043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.3||0.378||95.0|-1.5|3.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||3.8|-1.5|0.378
74001586|NCT00409773|147552043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|1.3||0.003||95.0|1.3|6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||6.6|1.3|0.003
74001587|NCT00409773|147552044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-13.3|-7.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-7.3|-13.3|<0.001
74001588|NCT00409773|147552044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-10.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.3|-10.2|<0.001
74001589|NCT00409773|147552044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.9|-3.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.9|-9.9|<0.001
74001590|NCT00409773|147552045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.6||0.809||95.0|-5.7|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.5|-5.7|0.809
74001591|NCT00409773|147552045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|2.6||0.217||95.0|-1.9|8.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||8.4|-1.9|0.217
74001592|NCT00409773|147552045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|2.6||0.796||95.0|-5.8|4.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.4|-5.8|0.796
74001593|NCT00409773|147552046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-12.1|-6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.6|-12.1|<0.001
74001594|NCT00409773|147552046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.1|-2.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.6|-8.1|<0.001
73877782|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-5.4|13.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - GI disorders||13.6|-5.4|
74001595|NCT00409773|147552046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.0|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.5|-8.0|<0.001
74001596|NCT00409773|147552047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.2||0.042||95.0|0.1|4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.8|0.1|0.042
74001597|NCT00409773|147552047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-0.2|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.5|-0.2|<0.001
74001598|NCT00409773|147552047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.0|4.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.0|-7.0|<0.001
73877783|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.2|||||TWO_SIDED|95.0|-2.0|11.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Gen. dis \& admin.||11.0|-2.0|
74001599|NCT00409773|147552048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-11.6|-6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.0|-11.6|<0.001
74001600|NCT00409773|147552048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.2|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.5|-8.2|<0.001
74001601|NCT00409773|147552048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.7|-3.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.1|-8.7|<0.001
74001602|NCT00409773|147552049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-17.6|-10.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-10.5|-17.6|<0.001
74001603|NCT00409773|147552049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.7|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-13.2|-6.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.1|-13.2|<0.001
74001604|NCT00409773|147552049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-12.0|-4.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.9|-12.0|<0.001
74001605|NCT00409773|147552050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-14.0|-8.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-8.0|-14.0|<0.001
73877784|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-4.2|7.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Gen. dis \& admin.||7.8|-4.2|
73877785|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-3.6|12.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Infect. \& Infest.||12.0|-3.6|
73877786|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||TWO_SIDED|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Infect. \& Infest.||8.0|-6.5|
74001606|NCT00409773|147552050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.4|-3.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.3|-9.4|<0.001
74001607|NCT00409773|147552050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-8.7|-2.7|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.7|-8.7|<0.001
74001608|NCT00409773|147552051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-15.0|-8.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-8.1|-15.0|<0.001
74001609|NCT00409773|147552051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-10.4|-3.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.6|-10.4|<0.001
74001610|NCT00409773|147552051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-11.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.3|-11.2|<0.001
74001611|NCT00409773|147552054|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.9||||0.42||95.0|-11.0|5.0|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||5.0|-11.0|0.420
74001612|NCT00409773|147552054|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.9||||0.555||95.0|-9.5|7.2|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||7.2|-9.5|0.555
74001613|NCT00409773|147552054|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.3||||0.41||95.0|-5.1|9.6|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||9.6|-5.1|0.410
74001614|NCT01919814|147552061|SUPERIORITY||||||>|0.05||||||Threshold P-Value was 0.05|t-test, 2 sided|||||||>0.05
74001615|NCT02164383|147552064|SUPERIORITY||Mean Difference (Final Values)|1.82||||0.85|TWO_SIDED||||||ANOVA||ANOVA results: F(1,28)=.04, p=.85, partial eta-squared (as a measure of effect size) = .001|||||.85
74001616|NCT02831387|147552067|SUPERIORITY||Mean Difference (Net)|-1.88||||0.749|TWO_SIDED|95.0|-13.696|9.936|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in the Subject Reported Dry Eye Questionnaire||9.936|-13.696|0.749
74001617|NCT02831387|147552068|SUPERIORITY||Mean Difference (Net)|-6.6||||0.267|TWO_SIDED|95.0|-18.4|5.3|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Frequency Scores||5.3|-18.4|0.267
74001618|NCT02831387|147552069|SUPERIORITY||Mean Difference (Net)|3.9||||0.495|TWO_SIDED|95.0|-7.6|15.4|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Severity Scores||15.4|-7.6|0.495
74001619|NCT02831387|147552070|SUPERIORITY||Mean Difference (Net)|0.6||||0.316|TWO_SIDED|95.0|-0.6|1.9|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Fluorescein Staining of the Cornea||1.9|-0.6|0.316
74001620|NCT02831387|147552071|SUPERIORITY||Mean Difference (Net)|-0.2||||0.823|TWO_SIDED|95.0|-1.9|1.5|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva||1.5|-1.9|0.823
74001621|NCT02831387|147552072|SUPERIORITY||Odds Ratio (OR)|1.923|||||TWO_SIDED|95.0|0.515|7.184||||||Statistical Analysis 1 for the Number of participants with at least 20% improvement in symptoms from baseline to Day 29||7.184|0.515|
74001622|NCT02831387|147552073|SUPERIORITY||Mean Difference (Net)|1.666||||0.723|TWO_SIDED|95.0|-7.759|11.092|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score||11.092|-7.759|0.723
74001623|NCT00192647|147552074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.2893|TWO_SIDED|95.0|0.88|1.52|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by viral load and country||||1.52|0.88|0.2893
74001624|NCT00192647|147552075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.91|1.63||||||||1.63|0.91|
74001625|NCT00192647|147552076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|1.24|2.27||||||Week 4||2.27|1.24|
74001626|NCT00192647|147552076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.24|2.17||||||Week 8||2.17|1.24|
74001627|NCT00192647|147552076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.4|2.53||||||Week 12||2.53|1.40|
74001628|NCT00192647|147552076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.08|1.98||||||Week 24||1.98|1.08|
74001629|NCT01828073|147552082|OTHER||Clopper-Pearson Confidence Interval (CI)|31.82|||||TWO_SIDED|90.0|16.0|51.5|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, adverse birth outcome, death)||51.50|16.00|
74001630|NCT01828073|147552082|OTHER||Clopper-Pearson Confidence Interval (CI)|50.0|||||TWO_SIDED|90.0|29.1|70.9|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, death)||70.90|29.10|
73877787|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Injury, poison.||5.1|-7.3|
73877788|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-5.0|8.5|||||Relebactam minus Placebo|Relebactam 1250mg - Placebo: Percentage Difference - Injury, poison.||8.5|-5.0|
73877789|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.2|||||TWO_SIDED|95.0|-9.8|7.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Investigations||7.4|-9.8|
73877790|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.9|||||TWO_SIDED|95.0|-10.5|6.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Investigations||6.5|-10.5|
74037112|NCT02768194|147627407|SUPERIORITY||Mean Difference (Net)|-0.1||||0.583|TWO_SIDED|95.0|-0.46|0.26||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.26|-0.46|0.5830
73877791|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nervous System||2.2|-8.4|
73877792|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nervous System||2.2|-8.4|
73877793|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-5.7|5.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Psychiatric disorders||5.4|-5.7|
73877794|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-5.7|5.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Psychiatric disorders||5.5|-5.7|
74001631|NCT01828073|147552086|OTHER|||||||0.747||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in full term infants.||||0.747
74001632|NCT01828073|147552086|OTHER|||||||0.341||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in LBW infants.||||0.341
74001633|NCT01350336|147552089|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 2 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.038|||||TWO_SIDED|95.0|-0.1251|0.0497||||||Comparison of Years 1 and 2||0.0497|-0.1251|
74001634|NCT01350336|147552089|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 3 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0325|||||TWO_SIDED|95.0|-0.1197|0.0565||||||Comparison of Years 1 and 3||0.0565|-0.1197|
73877795|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Renal \& Urinary||3.0|-7.2|
73877796|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Renal \& Urinary||3.0|-7.2|
73877797|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||TWO_SIDED|95.0|-10.7|0.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Resp. \& chest||0.7|-10.7|
73877798|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-8.4|4.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Resp. \& chest||4.4|-8.4|
73877799|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||TWO_SIDED|95.0|-2.4|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Skin \& subcutan.||8.1|-2.4|
73877800|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||TWO_SIDED|95.0|-4.7|4.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Skin \& subcutan.||4.5|-4.7|
74001635|NCT01350336|147552089|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 4 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0566|||||TWO_SIDED|95.0|-0.1444|0.0329||||||Comparison of Years 1 and 4||0.0329|-0.1444|
74001636|NCT01350336|147552089|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 5 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0765|||||TWO_SIDED|95.0|-0.1661|0.013||||||Comparison of Years 1 and 5||0.0130|-0.1661|
74037113|NCT00099359|147627451|SUPERIORITY_OR_OTHER|||||||0.046||||||Overall comparison of 3 KM curves using an extension of the M-H test was performed. Results indicated a significant difference therefore a 2nd stage analysis was done to compare each pair of transmission rates, using 2-sample Mantel-Haenzel tests.|multiple comparison|Hochberg's modified Bonferroni method was used to adjust the significance level for comparisons between arms.||||||.046
74037114|NCT00099359|147627452|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||.0001
74037115|NCT00099359|147627453|SUPERIORITY_OR_OTHER|||||||0.2432|||||||multiple comparison|||||||.2432
74037116|NCT00099359|147627454|SUPERIORITY_OR_OTHER|||||||0.49|||||||Chi-squared|||||||0.49
74037117|NCT00099359|147627457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.05|TWO_SIDED|95.0|0.24|1.01|||Regression, Logistic|Adjusted Odds ratio for treatment arm C (ZDV+3TC/NFV) association with Intrapartum Infection Status with Treatment Arm A (ZDV only) as reference group||||1.01|0.24|0.05
74037118|NCT00099359|147627457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.01|TWO_SIDED|95.0|0.19|0.82||Adjusted odds ratio for association of treatment arm B (ZDV+NVP) with intrapartum infection status with Treatment Arm A (ZDV only) as reference.|Regression, Logistic|||||0.82|0.19|0.01
74037119|NCT00099359|147627457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.03|TWO_SIDED|95.0|1.08|5.86|||Regression, Logistic|"Adjusted odds ratio for association of illegal substance use during pregnancy and intrapartum HIV infection status with NO being reference group."||||5.86|1.08|0.03
74037120|NCT00099359|147627457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.56|3.35||Adjusted odds ratio for the association of continuous log10 viral load with intrapartum infection status|Regression, Logistic|||||3.35|1.56|<0.0001
74001637|NCT03719170|147552101|SUPERIORITY||Slope|0.0000684|||||TWO_SIDED|95.0|-0.0003|0.000413||||||"Power Calculation:~Assuming approximately the same number of eligible subjects in each VISN (with an average of 10,563 candidates per VISN) and an Intraclass correlation coefficient (ICC) of 0.12, randomizing 17 VISNs will give more than 80% power to detect % days on PPI of 75% vs. 50%, 85% vs. 60%, 80% vs. 55%, or 70% vs. 45%, but to detect a difference between 70% vs. 50%, power is only 61% using 0.05 level 2-sided test."||0.000413|-0.0003|
74001638|NCT02079610|147552102|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|3.93|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74037121|NCT00230100|147627496|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
74037122|NCT00230100|147627497|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
74037123|NCT00230100|147627498|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
74037124|NCT00230100|147627499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||It was hypothesized that the single-gender group composition and women-focused group content (WRG) would result in better substance abuse treatment outcomes (lower ASI alcohol composite scores) than standard mixed-gender group treatment (GDC).||||<0.05
74001639|NCT02079610|147552103|SUPERIORITY||Mean Difference (Final Values)|8.2|STANDARD_DEVIATION|5.2||0.03|TWO_SIDED||||||Mixed Models Analysis|||||||0.03
74001640|NCT02079610|147552104|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|3.5||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
74001641|NCT01016977|147552113|SUPERIORITY_OR_OTHER|||||||0.9597||95.0||||Week 1|ANCOVA|||||||0.9597
74001642|NCT01016977|147552113|SUPERIORITY_OR_OTHER|||||||0.5538||95.0||||Week 2|ANCOVA|||||||0.5538
74037125|NCT00230100|147627500|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.009|||||||Mixed Models Analysis|||||||<0.009
74037126|NCT04465396|147627510|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% confidence interval (CI) of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|109.22|||||TWO_SIDED|90.0|104.83|113.8|||||The analysis was performed using Proc Mixed in statistical software suite (SAS), with treatment, sequence, period, and participant within sequence as fixed effects.|||113.80|104.83|
74037127|NCT04465396|147627510|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|113.99|||||TWO_SIDED|90.0|108.32|119.95|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||119.95|108.32|
74037128|NCT04465396|147627511|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|98.27|||||TWO_SIDED|90.0|88.5|109.11|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||109.11|88.50|
73877801|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||TWO_SIDED|95.0|-9.9|2.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vascular disorders||2.0|-9.9|
73877802|NCT01506271|147295333|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-6.9|6.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vascular disorders||6.6|-6.9|
73877803|NCT02021565|147295343|SUPERIORITY|||||||0.973||||||alpha = 0.025|ANOVA|Repeated measures||Analysis 1 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks with assistance from the informal caregiver.||||0.973
74001643|NCT01016977|147552113|SUPERIORITY_OR_OTHER|||||||0.6315||95.0||||Week 4|ANCOVA|||||||0.6315
74001644|NCT01016977|147552113|SUPERIORITY_OR_OTHER|||||||0.5655||95.0||||Week 8|ANCOVA|||||||0.5655
74001645|NCT01016977|147552113|SUPERIORITY_OR_OTHER|||||||0.7917||95.0||||Week 12|ANCOVA|||||||0.7917
74037129|NCT04465396|147627511|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|92.48|||||TWO_SIDED|90.0|83.8|102.05|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||102.05|83.80|
74037130|NCT04465396|147627512|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|109.44|||||TWO_SIDED|90.0|105.51|113.51|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||113.51|105.51|
74037131|NCT04465396|147627512|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|118.4|||||TWO_SIDED|90.0|112.31|124.83|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||124.83|112.31|
74037132|NCT00547638|147627547|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of DERMABOND HVD successful subjects) does not exceed 8%.|Difference in Proportion of Successes|-7.9|||||TWO_SIDED|95.0|-17.7|1.0|||Gart-Nam||The value for the Estimated Parameter is expressed as a percentage and is defined as the difference in the proportion of sucesses between study groups.|||1.0|-17.7|
74037133|NCT00547638|147627548|SUPERIORITY_OR_OTHER|||||||0.457||||||The total mHCS scores are summarized as proportion of subjects with good outcome (total scores of zero) and a comparison of treatment groups by Fisher Exact Test was performed to confirm differences in groups.|Fisher Exact|||||||0.457
74037134|NCT00547638|147627549|SUPERIORITY_OR_OTHER|||||||1||95.0||||Differences between treatment groups in the incidence rate of infection at Day 14 and Day 30 were compared using the Fisher's Exact Test.|Fisher Exact|||||||1.0000
74001646|NCT01016977|147552114|SUPERIORITY_OR_OTHER|||||||0.5961||95.0||||Week 1|ANCOVA|||||||0.5961
74037135|NCT00547638|147627549|SUPERIORITY_OR_OTHER|||||||1||95.0||||Differences between treatment groups in the incidence rate of infection at Day 30 were compared using the Fisher's Exact Test.|Fisher Exact|||||||1.0000
74037136|NCT00547638|147627550|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||Intent to treat population was analyzed.|Fisher Exact|||||||0.188
73877804|NCT02021565|147295343|SUPERIORITY|Alpha = .025||||||0.223|||||||ANOVA|||Analysis 2 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks independently.||||0.223
73877805|NCT02021565|147295344|SUPERIORITY|||||||0.547|||||||ANOVA|||Analysis 1 is for the Veteran care recipient reported task efficacy||||0.547
74001647|NCT01016977|147552114|SUPERIORITY_OR_OTHER|||||||0.2293||95.0||||Week 2|ANCOVA|||||||0.2293
74001648|NCT01016977|147552114|SUPERIORITY_OR_OTHER|||||||0.9852||95.0||||Week 4|ANCOVA|||||||0.9852
74001649|NCT01016977|147552114|SUPERIORITY_OR_OTHER|||||||0.5538||95.0||||Week 8|ANCOVA|||||||0.5538
74001650|NCT01016977|147552114|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||Week 12|ANCOVA|||||||0.6540
74001651|NCT01016977|147552115|SUPERIORITY_OR_OTHER|||||||0.8545||95.0||||Week 1|ANCOVA|||||||0.8545
74001652|NCT01016977|147552115|SUPERIORITY_OR_OTHER|||||||0.2895||95.0||||Week 2|ANCOVA|||||||0.2895
74001653|NCT01016977|147552115|SUPERIORITY_OR_OTHER|||||||0.8234||95.0||||Week 4|ANCOVA|||||||0.8234
74001654|NCT01016977|147552115|SUPERIORITY_OR_OTHER|||||||0.3644||95.0||||Week 8|ANCOVA|||||||0.3644
74001655|NCT01016977|147552115|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||Week 12|ANCOVA|||||||0.6540
74001656|NCT01016977|147552116|SUPERIORITY_OR_OTHER|||||||0.7546||95.0||||Week 1|ANCOVA|||||||0.7546
74001657|NCT01016977|147552116|SUPERIORITY_OR_OTHER|||||||0.7705||95.0||||Week 2|ANCOVA|||||||0.7705
74001658|NCT01016977|147552116|SUPERIORITY_OR_OTHER|||||||0.0259||95.0||||Week 4|ANCOVA|||||||0.0259
74001659|NCT01016977|147552116|SUPERIORITY_OR_OTHER|||||||0.9252||95.0||||Week 8|ANCOVA|||||||0.9252
74037137|NCT00547638|147627550|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Intent to treat population was analyzed.|Fisher Exact|||||||0.883
74037138|NCT00547638|147627551|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0000
74037139|NCT00975195|147627560|NON_INFERIORITY_OR_EQUIVALENCE|Upper limit of 95% confidence interval (CI) \<1.2 indicates non-inferiority of Fluticasone withdrawal compared with Fluticasone maintenance|Hazard Ratio (HR)|1.058||||0.3497|TWO_SIDED|95.0|0.941|1.189||Two-sided p-value to test superiority of fluticasone maintenance over fluticasone withdrawal if non-inferiority shown.|Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.189|0.941|0.3497
74037140|NCT00975195|147627561|SUPERIORITY_OR_OTHER||Rate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.06||0.4441|TWO_SIDED|95.0|0.93|1.18|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.18|0.93|0.4441
74037141|NCT00975195|147627562|SUPERIORITY_OR_OTHER|||||||0.2269|TWO_SIDED||||||Fisher Exact|||||||0.2269
73877806|NCT02021565|147295344|SUPERIORITY|||||||0.891|||||||ANOVA|||Analysis 2 is for the Veteran reported confidence that he/she can perform 10 transfer tasks independently.||||0.891
73877807|NCT02021565|147295345|SUPERIORITY|||||||0.729|||||||ANOVA|||||||0.729
74001660|NCT01016977|147552116|SUPERIORITY_OR_OTHER|||||||0.2927||95.0||||Week 12|ANCOVA|||||||0.2927
74001661|NCT01016977|147552117|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Week 1|ANCOVA|||||||0.4010
74001662|NCT01016977|147552117|SUPERIORITY_OR_OTHER|||||||0.0963||95.0||||Week 2|ANCOVA|||||||0.0963
74001663|NCT01016977|147552117|SUPERIORITY_OR_OTHER|||||||0.9291||95.0||||Week 4|ANCOVA|||||||0.9291
74001664|NCT01016977|147552117|SUPERIORITY_OR_OTHER|||||||0.5523||95.0||||Week 8|ANCOVA|||||||0.5523
74001665|NCT01016977|147552117|SUPERIORITY_OR_OTHER|||||||0.2556||95.0||||Week 12|ANCOVA|||||||0.2556
74001666|NCT01016977|147552118|SUPERIORITY_OR_OTHER|||||||0.4037||95.0||||Week 1|ANCOVA|||||||0.4037
74001667|NCT01016977|147552118|SUPERIORITY_OR_OTHER|||||||0.8662||95.0||||Week 2|ANCOVA|||||||0.8662
73877808|NCT03040141|147295346|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|1.9||||0.181|TWO_SIDED|95.0|1.03|13.55|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||13.55|1.03|0.181
73877809|NCT03040141|147295346|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|3.3||||0.073|TWO_SIDED|95.0|0.9|12.13|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||12.13|0.90|0.073
74001668|NCT01016977|147552118|SUPERIORITY_OR_OTHER|||||||0.5951||95.0||||Week 4|ANCOVA|||||||0.5951
74001669|NCT01016977|147552118|SUPERIORITY_OR_OTHER|||||||0.2349||95.0||||Week 8|ANCOVA|||||||0.2349
74001670|NCT01016977|147552118|SUPERIORITY_OR_OTHER|||||||0.3461||95.0||||Week 12|ANCOVA|||||||0.3461
74001671|NCT01016977|147552119|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||Week 1|ANCOVA|||||||0.7250
74001672|NCT01016977|147552119|SUPERIORITY_OR_OTHER|||||||0.9743||95.0||||Week 2|ANCOVA|||||||0.9743
74001673|NCT01016977|147552119|SUPERIORITY_OR_OTHER|||||||0.9816||95.0||||Week 4|ANCOVA|||||||0.9816
74001674|NCT01016977|147552119|SUPERIORITY_OR_OTHER|||||||0.8809||95.0||||Week 8|ANCOVA|||||||0.8809
74001675|NCT01016977|147552119|SUPERIORITY_OR_OTHER|||||||0.1679||95.0||||Week 12|ANCOVA|||||||0.1679
73877810|NCT03040141|147295346|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|3.5||||0.037|TWO_SIDED|95.0|1.08|11.48|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||11.48|1.08|0.037
73877811|NCT03040141|147295346|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|1.1||||0.814|TWO_SIDED|95.0|0.4|3.25|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||3.25|0.40|0.814
74001676|NCT00477334|147552128|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.26||||0.4161|TWO_SIDED|95.0|-0.4|0.98|||Hodges-Lehman Shift Model||Difference in time to healing= time to healing for Famciclovir-time to healing for Placebo. Hodges-Lehman shift model is used to estimate the difference in treatment effect. P-value is from the Wilcoxon rank-sum test.|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status are imputed according to the distribution of the time to healing among the subjects in the placebo group whose time to healing is greater than or equal to the observed discontinuation time. (Censor time)||0.98|-0.40|0.4161
74001677|NCT00477334|147552128|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01||||0.9372|TWO_SIDED|95.0|0.74|1.39|||Kaplan-Meier & Cox Regression||"Hazard ratio in time to healing=hazard rate of Famciclovir/hazard rate of Placebo.~Based on Cox proportional hazards model with treatment, pooled center and gender as explanatory variables."|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were censored at the time of the last clinical lesion observation.||1.39|0.74|0.9372
74001678|NCT03486457|147552190|SUPERIORITY||Difference in percentage of participants|32.35|STANDARD_ERROR_OF_MEAN|5.05|<|0.0001|TWO_SIDED|95.0|22.45|42.25|||Normal approximation|||The normal approximation to the difference in binomial proportions was used to test the difference between tofacitinib 5 mg BID and placebo and to generate 95% CI and p-value for the difference in response rates.||42.25|22.45|<0.0001
74001679|NCT03486457|147552191|SUPERIORITY||Difference in percentage of participants|15.44|STANDARD_ERROR_OF_MEAN|4.79||0.0013|TWO_SIDED|95.0|6.05|24.83|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.83|6.05|0.0013
74001680|NCT03486457|147552191|SUPERIORITY||Difference in percentage of participants|30.15|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|95.0|19.53|40.76|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.76|19.53|<0.0001
74001681|NCT03486457|147552191|SUPERIORITY||Difference in percentage of participants|51.47|STANDARD_ERROR_OF_MEAN|5.56|<|0.0001|TWO_SIDED|95.0|40.57|62.37|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||62.37|40.57|<0.0001
74001682|NCT03486457|147552191|SUPERIORITY||Difference in percentage of participants|36.76|STANDARD_ERROR_OF_MEAN|6.81|<|0.0001|TWO_SIDED|95.0|23.41|50.12|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||50.12|23.41|<0.0001
74037142|NCT00975195|147627563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.0849|TWO_SIDED|95.0|0.975|1.481|||Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.481|0.975|0.0849
73877812|NCT03040141|147295348|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.748||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level. The goal will be used to assess the strength of evidence to select the endpoints for a Phase 3 trial.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.748
73877813|NCT03040141|147295348|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.94||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference||||0.940
74001683|NCT03486457|147552191|SUPERIORITY||Difference in percentage of participants|24.26|STANDARD_ERROR_OF_MEAN|7.21||0.0008|TWO_SIDED|95.0|10.14|38.39|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||38.39|10.14|0.0008
74001684|NCT03486457|147552191|SUPERIORITY||Difference in percentage of participants|13.97|STANDARD_ERROR_OF_MEAN|7.08||0.0486|TWO_SIDED|95.0|0.09|27.85|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||27.85|0.09|0.0486
74001685|NCT03486457|147552192|SUPERIORITY||Difference in percentage of participants|1.1|STANDARD_ERROR_OF_MEAN|1.53||0.473|TWO_SIDED|95.0|-1.9|4.1|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||4.10|-1.90|0.4730
74001686|NCT03486457|147552192|SUPERIORITY||Difference in percentage of participants|1.83|STANDARD_ERROR_OF_MEAN|1.69||0.2792|TWO_SIDED|95.0|-1.48|5.14|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||5.14|-1.48|0.2792
74001687|NCT03486457|147552192|SUPERIORITY||Difference in percentage of participants|7.35|STANDARD_ERROR_OF_MEAN|2.84||0.0095|TWO_SIDED|95.0|1.79|12.91|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||12.91|1.79|0.0095
74001688|NCT03486457|147552192|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|95.0|6.63|19.84|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||19.84|6.63|<0.0001
74001689|NCT03486457|147552192|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|4.69||0.0048|TWO_SIDED|95.0|4.03|22.44|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.44|4.03|0.0048
74001690|NCT03486457|147552192|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|6.6||0.0449|TWO_SIDED|95.0|0.3|26.17|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||26.17|0.30|0.0449
74037143|NCT00975195|147627564|SUPERIORITY_OR_OTHER||Rate ratio|1.15|STANDARD_ERROR_OF_MEAN|0.13||0.2291|TWO_SIDED|95.0|0.92|1.45|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.45|0.92|0.2291
74001691|NCT03486457|147552193|SUPERIORITY||Difference in percentage of participants|2.94|STANDARD_ERROR_OF_MEAN|2.29||0.1985|TWO_SIDED|95.0|-1.54|7.42|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||7.42|-1.54|0.1985
74001692|NCT03486457|147552193|SUPERIORITY||Difference in percentage of participants|8.09|STANDARD_ERROR_OF_MEAN|2.91||0.0055|TWO_SIDED|95.0|2.38|13.8|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||13.80|2.38|0.0055
74001693|NCT03486457|147552193|SUPERIORITY||Difference in percentage of participants|27.21|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|18.51|35.9|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||35.90|18.51|<0.0001
74001694|NCT03486457|147552193|SUPERIORITY||Difference in percentage of participants|22.06|STANDARD_ERROR_OF_MEAN|6.37||0.0005|TWO_SIDED|95.0|9.58|34.54|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||34.54|9.58|0.0005
74001695|NCT03486457|147552193|SUPERIORITY||Difference in percentage of participants|18.38|STANDARD_ERROR_OF_MEAN|7.24||0.0111|TWO_SIDED|95.0|4.2|32.57|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.57|4.20|0.0111
74001696|NCT03486457|147552194|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.044||0.0097|TWO_SIDED|95.0|-0.2|-0.03|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.03|-0.20|0.0097
74037144|NCT00975195|147627565|SUPERIORITY_OR_OTHER|||||||0.2083|TWO_SIDED||||||Fisher Exact|||||||0.2083
74037145|NCT00975195|147627566|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.5562|TWO_SIDED|95.0|0.923|1.16|||Chi-squared|||||1.160|0.923|0.5562
74001697|NCT03486457|147552194|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.045||0.0043|TWO_SIDED|95.0|-0.22|-0.04|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.04|-0.22|0.0043
74001698|NCT03486457|147552194|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.3|-0.11|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.11|-0.30|<0.0001
74001699|NCT03486457|147552194|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001|TWO_SIDED|95.0|-0.32|-0.11|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.11|-0.32|<0.0001
74001700|NCT03486457|147552194|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.046||0.0535|TWO_SIDED|95.0|-0.18|0.0|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.18|0.0535
74001701|NCT03486457|147552194|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.094|TWO_SIDED|95.0|-0.16|0.01|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.16|0.0940
74001702|NCT03486457|147552195|SUPERIORITY||Difference in percentage of participants|13.07|STANDARD_ERROR_OF_MEAN|8.56||0.127|TWO_SIDED|95.0|-3.72|29.85|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.85|-3.72|0.1270
74001703|NCT03486457|147552195|SUPERIORITY||Difference in percentage of participants|4.02|STANDARD_ERROR_OF_MEAN|9.23||0.6634|TWO_SIDED|95.0|-14.07|22.1|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.10|-14.07|0.6634
74001704|NCT03486457|147552195|SUPERIORITY||Difference in percentage of participants|21.78|STANDARD_ERROR_OF_MEAN|9.46||0.0214|TWO_SIDED|95.0|3.23|40.33|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.33|3.23|0.0214
74001705|NCT03486457|147552195|SUPERIORITY||Difference in percentage of participants|24.03|STANDARD_ERROR_OF_MEAN|9.46||0.011|TWO_SIDED|95.0|5.5|42.57|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||42.57|5.50|0.0110
74001706|NCT03486457|147552195|SUPERIORITY||Difference in percentage of participants|12.57|STANDARD_ERROR_OF_MEAN|9.58||0.1896|TWO_SIDED|95.0|-6.21|31.36|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||31.36|-6.21|0.1896
74001707|NCT03486457|147552195|SUPERIORITY||Difference in percentage of participants|6.83|STANDARD_ERROR_OF_MEAN|8.97||0.4466|TWO_SIDED|95.0|-10.75|24.41|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.41|-10.75|0.4466
74001708|NCT03486457|147552196|SUPERIORITY||Difference in percentage of participants|13.07|STANDARD_ERROR_OF_MEAN|8.56||0.127|TWO_SIDED|95.0|-3.72|29.85|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.85|-3.72|0.1270
74001709|NCT03486457|147552196|SUPERIORITY||Difference in percentage of participants|4.02|STANDARD_ERROR_OF_MEAN|9.23||0.6634|TWO_SIDED|95.0|-14.07|22.1|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.10|-14.07|0.6634
74001710|NCT03486457|147552196|SUPERIORITY||Difference in percentage of participants|21.78|STANDARD_ERROR_OF_MEAN|9.46||0.0214|TWO_SIDED|95.0|3.23|40.33|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.33|3.23|0.0214
74001711|NCT03486457|147552196|SUPERIORITY||Difference in percentage of participants|24.03|STANDARD_ERROR_OF_MEAN|9.46||0.011|TWO_SIDED|95.0|5.5|42.57|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||42.57|5.50|0.0110
74001712|NCT03486457|147552196|SUPERIORITY||Difference in percentage of participants|12.57|STANDARD_ERROR_OF_MEAN|9.58||0.1896|TWO_SIDED|95.0|-6.21|31.36|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||31.36|-6.21|0.1896
74037146|NCT00975195|147627567|SUPERIORITY_OR_OTHER||Rate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.06||0.4342|TWO_SIDED|95.0|0.93|1.18|||Regression, Negative binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.18|0.93|0.4342
74037147|NCT00975195|147627568|SUPERIORITY_OR_OTHER|||||||0.3155|TWO_SIDED||||||Fisher Exact|||||||0.3155
74037148|NCT00975195|147627570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.0134||0.0014|TWO_SIDED|95.0|-0.069|-0.017|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.017|-0.069|0.0014
74037149|NCT00975195|147627571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.064|STANDARD_ERROR_OF_MEAN|0.034||0.0632|TWO_SIDED|95.0|-0.004|0.131|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.131|-0.004|0.0632
74037150|NCT00975195|147627572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.055||0.8137|TWO_SIDED|95.0|-0.122|0.096|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.096|-0.122|0.8137
74037151|NCT00975195|147627573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.53|STANDARD_ERROR_OF_MEAN|3.17||0.2663|TWO_SIDED|95.0|-9.74|2.69|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.69|-9.74|0.2663
74037152|NCT00975195|147627574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.06||0.0033|TWO_SIDED|95.0|0.05|0.27|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.27|0.05|0.0033
73877814|NCT03040141|147295348|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.902||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The total VIS410 high-dose group (high-dose + low-dose) was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.902
74037153|NCT00975195|147627575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.499||0.4914|TWO_SIDED|95.0|-3.98|1.91|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||1.91|-3.98|0.4914
74037154|NCT00975195|147627576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|1.669||0.349|TWO_SIDED|95.0|-4.84|1.71|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||1.71|-4.84|0.3490
74037155|NCT00975195|147627577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.48||0.9262|TWO_SIDED|95.0|-2.77|3.04|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||3.04|-2.77|0.9262
74091728|NCT05472662|147737053|OTHER||Adjusted mean difference|-0.024||||0.282|TWO_SIDED|95.0|-0.068|0.021|||ANCOVA|||"Statistical analysis performed on the data at 3 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.021|-0.068|0.282
73877815|NCT03040141|147295348|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.283||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.||||0.283
73877816|NCT03040141|147295349|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.919||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.919
74001713|NCT03486457|147552196|SUPERIORITY||Difference in percentage of participants|6.83|STANDARD_ERROR_OF_MEAN|8.97||0.4466|TWO_SIDED|95.0|-10.75|24.41|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.41|-10.75|0.4466
74001714|NCT03486457|147552197|SUPERIORITY||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.633|<|0.0001|TWO_SIDED|95.0|-3.95|-1.45|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.45|-3.95|<0.0001
74001715|NCT03486457|147552197|SUPERIORITY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|0.711|<|0.0001|TWO_SIDED|95.0|-5.2|-2.39|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.39|-5.20|<0.0001
74001716|NCT03486457|147552197|SUPERIORITY||LS mean difference|-4.89|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|95.0|-6.39|-3.39|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.39|-6.39|<0.0001
74001717|NCT03486457|147552197|SUPERIORITY||LS mean difference|-5.85|STANDARD_ERROR_OF_MEAN|0.852|<|0.0001|TWO_SIDED|95.0|-7.53|-4.17|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.17|-7.53|<0.0001
74001718|NCT03486457|147552197|SUPERIORITY||LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.583|<|0.0001|TWO_SIDED|95.0|-4.35|-2.04|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.04|-4.35|<0.0001
74037156|NCT00975195|147627578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.64|STANDARD_ERROR_OF_MEAN|1.716||0.1241|TWO_SIDED|95.0|-0.73|6.01|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||6.01|-0.73|0.1241
74037157|NCT00975195|147627579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.0123|<|0.0001|TWO_SIDED|95.0|-0.073|-0.024|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.024|-0.073|<0.0001
73877817|NCT03040141|147295349|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.9||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.900
73877818|NCT03040141|147295349|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.99||||||p-value is not adjusted for multiple comparisons|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level||The combined VIS410 high- and low-dose groups was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.990
73877819|NCT03040141|147295349|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.521||||||The p-value is not adjusted for multiple comparisons.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.||||0.521
74001719|NCT03486457|147552197|SUPERIORITY||LS mean difference|-2.59|STANDARD_ERROR_OF_MEAN|0.668||0.0002|TWO_SIDED|95.0|-3.91|-1.27|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.27|-3.91|0.0002
74001720|NCT03486457|147552198|SUPERIORITY||LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.012||0.001|TWO_SIDED|95.0|-5.4|-1.4|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.40|-5.40|0.0010
74001721|NCT03486457|147552198|SUPERIORITY||LS mean difference|-5.03|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|95.0|-7.05|-3.01|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.01|-7.05|<0.0001
74001722|NCT03486457|147552198|SUPERIORITY||LS mean difference|-5.68|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|-7.7|-3.66|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.66|-7.70|<0.0001
74001723|NCT03486457|147552198|SUPERIORITY||LS mean difference|-7.01|STANDARD_ERROR_OF_MEAN|1.111|<|0.0001|TWO_SIDED|95.0|-9.2|-4.82|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.82|-9.20|<0.0001
74037158|NCT00975195|147627580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.044|STANDARD_ERROR_OF_MEAN|0.0255||0.0855|TWO_SIDED|95.0|-0.094|0.006|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.006|-0.094|0.0855
73877820|NCT03040141|147295350|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.36||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|ANOVA|||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.360
73877821|NCT03040141|147295351|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.735|||||||ANOVA|||||||0.735
73877822|NCT03040141|147295351|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.259|||||||ANOVA|||||||0.259
73877823|NCT03040141|147295351|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.644||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.644
74001724|NCT03486457|147552198|SUPERIORITY||LS mean difference|-3.95|STANDARD_ERROR_OF_MEAN|1.073||0.0003|TWO_SIDED|95.0|-6.07|-1.83|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.83|-6.07|0.0003
74001725|NCT03486457|147552198|SUPERIORITY||LS mean difference|-2.39|STANDARD_ERROR_OF_MEAN|1.108||0.0323|TWO_SIDED|95.0|-4.58|-0.2|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.20|-4.58|0.0323
74001726|NCT03486457|147552199|SUPERIORITY||LS mean difference|-6.57|STANDARD_ERROR_OF_MEAN|2.481||0.0087|TWO_SIDED|95.0|-11.46|-1.68|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.68|-11.46|0.0087
74001727|NCT03486457|147552199|SUPERIORITY||LS mean difference|-11.7|STANDARD_ERROR_OF_MEAN|2.487|<|0.0001|TWO_SIDED|95.0|-16.6|-6.79|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.79|-16.60|<0.0001
74001728|NCT03486457|147552199|SUPERIORITY||LS mean difference|-16.14|STANDARD_ERROR_OF_MEAN|2.796|<|0.0001|TWO_SIDED|95.0|-21.66|-10.63|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.63|-21.66|<0.0001
73877824|NCT03040141|147295351|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.146|||||||ANOVA|||||||0.146
73877825|NCT03040141|147295352|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.624||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.624
73877826|NCT03040141|147295352|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.399||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.399
74001729|NCT03486457|147552199|SUPERIORITY||LS mean difference|-21.87|STANDARD_ERROR_OF_MEAN|3.027|<|0.0001|TWO_SIDED|95.0|-27.84|-15.9|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-15.90|-27.84|<0.0001
74001730|NCT03486457|147552199|SUPERIORITY||LS mean difference|-6.94|STANDARD_ERROR_OF_MEAN|2.865||0.0163|TWO_SIDED|95.0|-12.6|-1.29|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.29|-12.60|0.0163
74001731|NCT03486457|147552199|SUPERIORITY||LS mean difference|-3.1|STANDARD_ERROR_OF_MEAN|2.967||0.2977|TWO_SIDED|95.0|-8.95|2.76|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.76|-8.95|0.2977
74001732|NCT03486457|147552200|SUPERIORITY||LS mean difference|-6.15|STANDARD_ERROR_OF_MEAN|2.646||0.0211|TWO_SIDED|95.0|-11.37|-0.93|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.93|-11.37|0.0211
74001733|NCT03486457|147552200|SUPERIORITY||LS mean difference|-13.08|STANDARD_ERROR_OF_MEAN|2.79|<|0.0001|TWO_SIDED|95.0|-18.59|-7.58|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-7.58|-18.59|<0.0001
74001734|NCT03486457|147552200|SUPERIORITY||LS mean difference|-13.16|STANDARD_ERROR_OF_MEAN|2.928|<|0.0001|TWO_SIDED|95.0|-18.93|-7.38|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-7.38|-18.93|<0.0001
74001735|NCT03486457|147552200|SUPERIORITY||LS mean difference|-18.77|STANDARD_ERROR_OF_MEAN|3.187|<|0.0001|TWO_SIDED|95.0|-25.06|-12.49|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.49|-25.06|<0.0001
74001736|NCT03486457|147552200|SUPERIORITY||LS mean difference|-7.01|STANDARD_ERROR_OF_MEAN|2.827||0.014|TWO_SIDED|95.0|-12.59|-1.43|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.43|-12.59|0.0140
74001737|NCT03486457|147552200|SUPERIORITY||LS mean difference|-5.14|STANDARD_ERROR_OF_MEAN|2.931||0.0811|TWO_SIDED|95.0|-10.93|0.64|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.64|-10.93|0.0811
74001738|NCT03486457|147552201|SUPERIORITY||LS mean difference|-9.64|STANDARD_ERROR_OF_MEAN|1.939|<|0.0001|TWO_SIDED|95.0|-13.46|-5.81|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.81|-13.46|<0.0001
74001739|NCT03486457|147552201|SUPERIORITY||LS mean difference|-9.52|STANDARD_ERROR_OF_MEAN|2.305|<|0.0001|TWO_SIDED|95.0|-14.07|-4.98|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.98|-14.07|<0.0001
74001740|NCT03486457|147552201|SUPERIORITY||LS mean difference|-16.97|STANDARD_ERROR_OF_MEAN|2.472|<|0.0001|TWO_SIDED|95.0|-21.85|-12.1|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.10|-21.85|<0.0001
74001741|NCT03486457|147552201|SUPERIORITY||LS mean difference|-18.42|STANDARD_ERROR_OF_MEAN|2.506|<|0.0001|TWO_SIDED|95.0|-23.36|-13.48|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-13.48|-23.36|<0.0001
74001742|NCT03486457|147552201|SUPERIORITY||LS mean difference|-7.22|STANDARD_ERROR_OF_MEAN|2.453||0.0037|TWO_SIDED|95.0|-12.06|-2.38|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.38|-12.06|0.0037
74001743|NCT03486457|147552201|SUPERIORITY||LS mean difference|-7.66|STANDARD_ERROR_OF_MEAN|2.267||0.0009|TWO_SIDED|95.0|-12.13|-3.18|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.18|-12.13|0.0009
74001744|NCT03486457|147552202|SUPERIORITY||LS mean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.108|<|0.0001|TWO_SIDED|95.0|-9.39|-5.02|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.02|-9.39|<0.0001
74001745|NCT03486457|147552202|SUPERIORITY||LS mean difference|-7.87|STANDARD_ERROR_OF_MEAN|1.171|<|0.0001|TWO_SIDED|95.0|-10.18|-5.56|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.56|-10.18|<0.0001
74001746|NCT03486457|147552202|SUPERIORITY||LS mean difference|-7.41|STANDARD_ERROR_OF_MEAN|1.182|<|0.0001|TWO_SIDED|95.0|-9.74|-5.08|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.08|-9.74|<0.0001
74001747|NCT03486457|147552202|SUPERIORITY||LS mean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.221|<|0.0001|TWO_SIDED|95.0|-10.21|-5.39|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.39|-10.21|<0.0001
74001748|NCT03486457|147552202|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.615||0.6264|TWO_SIDED|95.0|-0.91|1.51|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||1.51|-0.91|0.6264
74001749|NCT03486457|147552202|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.778||0.1008|TWO_SIDED|95.0|-2.82|0.25|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.25|-2.82|0.1008
73877827|NCT03040141|147295352|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.837|||||||ANOVA|||||||0.837
74001750|NCT03486457|147552203|SUPERIORITY||Difference in percentage of participants|0.44|STANDARD_ERROR_OF_MEAN|1.77||0.8032|TWO_SIDED|95.0|-3.02|3.9|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||3.90|-3.02|0.8032
74001751|NCT03486457|147552203|SUPERIORITY||Difference in percentage of participants|7.47|STANDARD_ERROR_OF_MEAN|3.44||0.0298|TWO_SIDED|95.0|0.73|14.21|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||14.21|0.73|0.0298
74001752|NCT03486457|147552203|SUPERIORITY||Difference in percentage of participants|-11.19|STANDARD_ERROR_OF_MEAN|6.48||0.084|TWO_SIDED|95.0|-23.88|1.5|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||1.50|-23.88|0.0840
74001753|NCT03486457|147552204|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.111||0.002|TWO_SIDED|95.0|-0.57|-0.13|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.13|-0.57|0.0020
74001754|NCT03486457|147552204|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.32|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.32|-0.87|<0.0001
74001755|NCT03486457|147552204|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.156||0.9678|TWO_SIDED|95.0|-0.3|0.31|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.31|-0.30|0.9678
74001756|NCT03486457|147552205|SUPERIORITY||Difference in percentage of participants|14.96|STANDARD_ERROR_OF_MEAN|5.78||0.0097|TWO_SIDED|95.0|3.63|26.3|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||26.30|3.63|0.0097
74001757|NCT03486457|147552205|SUPERIORITY||Difference in percentage of participants|24.89|STANDARD_ERROR_OF_MEAN|8.2||0.0024|TWO_SIDED|95.0|8.81|40.97|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.97|8.81|0.0024
74001758|NCT03486457|147552205|SUPERIORITY||Difference in percentage of participants|-17.93|STANDARD_ERROR_OF_MEAN|11.03||0.1042|TWO_SIDED|95.0|-39.55|3.7|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||3.70|-39.55|0.1042
74037159|NCT00975195|147627581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.161|STANDARD_ERROR_OF_MEAN|0.045||0.0004|TWO_SIDED|95.0|-0.249|-0.073|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.073|-0.249|0.0004
74037160|NCT00975195|147627582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.97|STANDARD_ERROR_OF_MEAN|0.728||0.1838|TWO_SIDED|95.0|-0.46|2.4|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.40|-0.46|0.1838
73877828|NCT03040141|147295352|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.183|||||||ANOVA|||||||0.183
73877829|NCT03040141|147295353|SUPERIORITY|The null hypothesis was defined as no treatment difference||||||0.88|||||||ANOVA|||||||0.880
74001759|NCT03486457|147552206|SUPERIORITY||LS mean difference|-25.89|STANDARD_ERROR_OF_MEAN|7.858||0.0014|TWO_SIDED|95.0|-41.49|-10.29|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.29|-41.49|0.0014
74001760|NCT03486457|147552206|SUPERIORITY||LS mean difference|-34.91|STANDARD_ERROR_OF_MEAN|8.948||0.0002|TWO_SIDED|95.0|-52.69|-17.13|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-17.13|-52.69|0.0002
74001761|NCT03486457|147552206|SUPERIORITY||LS mean difference|5.31|STANDARD_ERROR_OF_MEAN|10.663||0.62|TWO_SIDED|95.0|-15.9|26.51|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||26.51|-15.90|0.6200
74001762|NCT03486457|147552207|SUPERIORITY||LS mean difference|-39.65|STANDARD_ERROR_OF_MEAN|10.862||0.0004|TWO_SIDED|95.0|-61.21|-18.08|||Mixed Models Analysis|||Month 1, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-18.08|-61.21|0.0004
74001763|NCT03486457|147552207|SUPERIORITY||LS mean difference|-25.18|STANDARD_ERROR_OF_MEAN|8.453||0.0037|TWO_SIDED|95.0|-41.97|-8.4|||Mixed Models Analysis|||Month 1, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-8.40|-41.97|0.0037
74001764|NCT03486457|147552207|SUPERIORITY||LS mean difference|-21.3|STANDARD_ERROR_OF_MEAN|10.423||0.0438|TWO_SIDED|95.0|-42.0|-0.61|||Mixed Models Analysis|||Month 1, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.61|-42.00|0.0438
74001765|NCT03486457|147552207|SUPERIORITY||LS mean difference|-49.11|STANDARD_ERROR_OF_MEAN|10.529|<|0.0001|TWO_SIDED|95.0|-70.03|-28.19|||Mixed Models Analysis|||Month 3, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-28.19|-70.03|<0.0001
74001766|NCT03486457|147552207|SUPERIORITY||LS mean difference|-29.71|STANDARD_ERROR_OF_MEAN|9.47||0.0023|TWO_SIDED|95.0|-48.52|-10.89|||Mixed Models Analysis|||Month 3, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.89|-48.52|0.0023
74090853|NCT00899470|147735873|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted ), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||TWO_SIDED|90.0|0.973|1.088|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(INF)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.973|
74090854|NCT00899470|147735873|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||TWO_SIDED|90.0|0.986|1.102|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of metformin, the point estimate and 90% confidence interval (CI) were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(INF)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.102|0.986|
74090855|NCT03456960|147735895|EQUIVALENCE|The difference in the least square means (LSM) between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0059|||||TWO_SIDED|90.0|-0.034|0.0458||||||||0.0458|-0.0340|
74090856|NCT03456960|147735896|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0508|||||TWO_SIDED|90.0|-0.0079|0.1096||||||||0.1096|-0.0079|
74090857|NCT03456960|147735897|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0546|||||TWO_SIDED|90.0|-0.0941|0.2034||||||||0.2034|-0.0941|
74001767|NCT03486457|147552207|SUPERIORITY||LS mean difference|-36.78|STANDARD_ERROR_OF_MEAN|10.72||0.0009|TWO_SIDED|95.0|-58.08|-15.49|||Mixed Models Analysis|||Month 3, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-15.49|-58.08|0.0009
74001768|NCT03486457|147552207|SUPERIORITY||LS mean difference|7.03|STANDARD_ERROR_OF_MEAN|10.495||0.5048|TWO_SIDED|95.0|-13.84|27.9|||Mixed Models Analysis|||Month 6, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||27.90|-13.84|0.5048
74001769|NCT03486457|147552207|SUPERIORITY||LS mean difference|9.16|STANDARD_ERROR_OF_MEAN|12.273||0.4575|TWO_SIDED|95.0|-15.24|33.57|||Mixed Models Analysis|||Month 6, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||33.57|-15.24|0.4575
74001770|NCT03486457|147552207|SUPERIORITY||LS mean difference|0.69|STANDARD_ERROR_OF_MEAN|11.539||0.9523|TWO_SIDED|95.0|-22.26|23.65|||Mixed Models Analysis|||Month 6, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||23.65|-22.26|0.9523
74001771|NCT03486457|147552208|SUPERIORITY||LS mean difference|-28.69|STANDARD_ERROR_OF_MEAN|8.386||0.0008|TWO_SIDED|95.0|-45.24|-12.15|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.15|-45.24|0.0008
74001772|NCT03486457|147552208|SUPERIORITY||LS mean difference|-46.47|STANDARD_ERROR_OF_MEAN|10.632|<|0.0001|TWO_SIDED|95.0|-67.45|-25.49|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-25.49|-67.45|<0.0001
74001773|NCT03486457|147552208|SUPERIORITY||LS mean difference|-26.76|STANDARD_ERROR_OF_MEAN|10.778||0.0141|TWO_SIDED|95.0|-48.05|-5.47|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.47|-48.05|0.0141
74001774|NCT03486457|147552209|SUPERIORITY||LS mean difference|-10.75|STANDARD_ERROR_OF_MEAN|2.399|<|0.0001|TWO_SIDED|95.0|-15.48|-6.02|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.02|-15.48|<0.0001
74037161|NCT00975195|147627583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35|STANDARD_ERROR_OF_MEAN|0.702||0.0551|TWO_SIDED|95.0|-0.03|2.72|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.72|-0.03|0.0551
74037162|NCT00975195|147627584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.845||0.4804|TWO_SIDED|95.0|-1.06|2.25|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.25|-1.06|0.4804
74037163|NCT00975195|147627585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.22|STANDARD_ERROR_OF_MEAN|0.614||0.0467|TWO_SIDED|95.0|0.02|2.43|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.43|0.02|0.0467
74037164|NCT00975195|147627586|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0223|TWO_SIDED|95.0|-0.21|-0.02|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.02|-0.21|0.0223
74090858|NCT03456960|147735897|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model will include a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0912|||||TWO_SIDED|90.0|0.0399|0.1424||||||||0.1424|0.0399|
74001775|NCT03486457|147552209|SUPERIORITY||LS mean difference|-19.45|STANDARD_ERROR_OF_MEAN|2.575|<|0.0001|TWO_SIDED|95.0|-24.52|-14.37|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-14.37|-24.52|<0.0001
74001776|NCT03486457|147552209|SUPERIORITY||LS mean difference|-6.7|STANDARD_ERROR_OF_MEAN|2.289||0.0039|TWO_SIDED|95.0|-11.22|-2.18|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.18|-11.22|0.0039
74037165|NCT01179347|147627587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|0.97||0.092||95.0|-0.27|3.55||Two-sided p-value.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing procedure was applied for both co-primary endpoints to maintain the overall alpha level. If and only if statistical superiority of the Tio R5 qd compared to Placebo in FEV1 AUC0-4h was demonstrated at the 1 sided alpha level of 0.025, confirmatory comparison in the second co-primary endpoint, at the same alpha level of 0.025 could be done .||3.55|-0.27|0.092
74001777|NCT03486457|147552210|SUPERIORITY||Difference in percentage of participants|14.19|STANDARD_ERROR_OF_MEAN|5.89||0.016|TWO_SIDED|95.0|2.64|25.73|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||25.73|2.64|0.0160
74037166|NCT01179347|147627588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.97||0.15||95.0|-0.5|3.3||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful,||3.30|-0.50|0.15
74037167|NCT01179347|147627589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_ERROR_OF_MEAN|0.9||0.23||95.0|-0.68|2.86||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||2.86|-0.68|0.23
74037168|NCT01179347|147627590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.93||0.19||95.0|-0.62|3.02||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||3.02|-0.62|0.19
74037169|NCT01179347|147627591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.76||0.62||95.0|-2.59|4.32||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||4.32|-2.59|0.62
74037170|NCT01179347|147627592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.092||||0.84||95.0|0.453|2.633||Two-sided p-value.|Regression, Logistic|Adjusted for treatment, age group, baseline weight and baseline FEV1 percent predicted.|Tio R5 qd versus Placebo.|||2.633|0.453|0.84
74090859|NCT03456960|147735898|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0916|||||TWO_SIDED|90.0|-0.133|0.3162||||||||0.3162|-0.1330|
74090860|NCT03456960|147735898|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.2293|||||TWO_SIDED|90.0|0.1519|0.3068||||||||0.3068|0.1519|
74037171|NCT00781963|147627632|SUPERIORITY||Mean Difference (Final Values)|-15.8|STANDARD_ERROR_OF_MEAN|6.6|<|0.001|TWO_SIDED|95.0|-28.7|-3.0|||Mixed Models Analysis||The parameter estimate is the improvement in sleep onset latency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-3.0|-28.7|<.001
74001778|NCT03486457|147552210|SUPERIORITY||Difference in percentage of participants|25.65|STANDARD_ERROR_OF_MEAN|8.06||0.0015|TWO_SIDED|95.0|9.86|41.44|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||41.44|9.86|0.0015
74001779|NCT03486457|147552210|SUPERIORITY||Difference in percentage of participants|23.05|STANDARD_ERROR_OF_MEAN|9.16||0.0118|TWO_SIDED|95.0|5.11|41.0|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||41.00|5.11|0.0118
74001780|NCT03486457|147552211|SUPERIORITY||LS mean difference|-3.09|STANDARD_ERROR_OF_MEAN|1.259||0.0156|TWO_SIDED|95.0|-5.58|-0.6|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.60|-5.58|0.0156
74001781|NCT03486457|147552211|SUPERIORITY||LS mean difference|-4.06|STANDARD_ERROR_OF_MEAN|0.989|<|0.0001|TWO_SIDED|95.0|-6.02|-2.1|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.10|-6.02|<0.0001
74001782|NCT03486457|147552211|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.346||0.0061|TWO_SIDED|95.0|-1.65|-0.28|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.28|-1.65|0.0061
74001783|NCT03486457|147552212|SUPERIORITY||Difference in percentage of participants|13.03|STANDARD_ERROR_OF_MEAN|10.01||0.193|TWO_SIDED|95.0|-6.59|32.64|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.64|-6.59|0.1930
74001784|NCT03486457|147552212|SUPERIORITY||Difference in percentage of participants|24.3|STANDARD_ERROR_OF_MEAN|10.11||0.0162|TWO_SIDED|95.0|4.48|44.11|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||44.11|4.48|0.0162
74001785|NCT03486457|147552212|SUPERIORITY||Difference in percentage of participants|4.07|STANDARD_ERROR_OF_MEAN|10.83||0.7068|TWO_SIDED|95.0|-17.15|25.3|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||25.30|-17.15|0.7068
74001786|NCT03486457|147552213|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.271||0.2811|TWO_SIDED|95.0|-0.83|0.25|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.25|-0.83|0.2811
74001787|NCT03486457|147552213|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.295||0.214|TWO_SIDED|95.0|-0.96|0.22|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.22|-0.96|0.2140
74001788|NCT03486457|147552213|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.239||0.2817|TWO_SIDED|95.0|-0.74|0.22|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.22|-0.74|0.2817
74001789|NCT03486457|147552214|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.182||0.9407|TWO_SIDED|95.0|-0.37|0.35|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.35|-0.37|0.9407
74001790|NCT03486457|147552214|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.293||0.4295|TWO_SIDED|95.0|-0.81|0.35|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.35|-0.81|0.4295
74001791|NCT03486457|147552214|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.314||0.2946|TWO_SIDED|95.0|-0.95|0.29|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.29|-0.95|0.2946
74001792|NCT03486457|147552215|SUPERIORITY||Difference in percentage of participants|21.32|STANDARD_ERROR_OF_MEAN|5.62||0.0001|TWO_SIDED|95.0|10.32|32.33|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.33|10.32|0.0001
74001793|NCT03486457|147552215|SUPERIORITY||Difference in percentage of participants|36.03|STANDARD_ERROR_OF_MEAN|6.49|<|0.0001|TWO_SIDED|95.0|23.31|48.75|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||48.75|23.31|<0.0001
74001794|NCT03486457|147552215|SUPERIORITY||Difference in percentage of participants|52.21|STANDARD_ERROR_OF_MEAN|5.79|<|0.0001|TWO_SIDED|95.0|40.86|63.55|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||63.55|40.86|<0.0001
74001795|NCT03486457|147552215|SUPERIORITY||Difference in percentage of participants|39.71|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|26.38|53.03|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||53.03|26.38|<0.0001
74001796|NCT03486457|147552215|SUPERIORITY||Difference in percentage of participants|18.38|STANDARD_ERROR_OF_MEAN|7.23||0.011|TWO_SIDED|95.0|4.22|32.55|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.55|4.22|0.0110
74090861|NCT03456960|147735899|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.01|||||TWO_SIDED|90.0|-0.0299|0.05||||||||0.0500|-0.0299|
74001797|NCT03486457|147552215|SUPERIORITY||Difference in percentage of participants|16.18|STANDARD_ERROR_OF_MEAN|6.8||0.0173|TWO_SIDED|95.0|2.85|29.5|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.50|2.85|0.0173
74001798|NCT03486457|147552216|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.79|-0.47|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.47|-0.79|<0.0001
74001799|NCT03486457|147552216|SUPERIORITY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-0.99|-0.62|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.62|-0.99|<0.0001
74001800|NCT03486457|147552216|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.105|<|0.0001|TWO_SIDED|95.0|-1.08|-0.66|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.66|-1.08|<0.0001
74001801|NCT03486457|147552216|SUPERIORITY||LS mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-1.28|-0.8|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.80|-1.28|<0.0001
74001802|NCT03486457|147552216|SUPERIORITY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.129||0.0009|TWO_SIDED|95.0|-0.69|-0.18|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.18|-0.69|0.0009
74001803|NCT03486457|147552216|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.145||0.1202|TWO_SIDED|95.0|-0.51|0.06|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.06|-0.51|0.1202
74001804|NCT03486457|147552217|SUPERIORITY||LS mean difference|3.72|STANDARD_ERROR_OF_MEAN|0.998||0.0003|TWO_SIDED|95.0|1.76|5.69|||Mixed Models Analysis|||Month 1, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.69|1.76|0.0003
74001805|NCT03486457|147552217|SUPERIORITY||LS mean difference|3.18|STANDARD_ERROR_OF_MEAN|1.102||0.0043|TWO_SIDED|95.0|1.01|5.35|||Mixed Models Analysis|||Month 1, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.35|1.01|0.0043
74001806|NCT03486457|147552217|SUPERIORITY||LS mean difference|3.12|STANDARD_ERROR_OF_MEAN|0.861||0.0004|TWO_SIDED|95.0|1.42|4.82|||Mixed Models Analysis|||Month 1, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.82|1.42|0.0004
74001807|NCT03486457|147552217|SUPERIORITY||LS mean difference|3.54|STANDARD_ERROR_OF_MEAN|0.938||0.0002|TWO_SIDED|95.0|1.69|5.39|||Mixed Models Analysis|||Month 1, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.39|1.69|0.0002
74001808|NCT03486457|147552217|SUPERIORITY||LS mean difference|3.04|STANDARD_ERROR_OF_MEAN|1.203||0.0123|TWO_SIDED|95.0|0.67|5.41|||Mixed Models Analysis|||Month 1, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.41|0.67|0.0123
74001809|NCT03486457|147552217|SUPERIORITY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.115||0.0216|TWO_SIDED|95.0|0.38|4.78|||Mixed Models Analysis|||Month 1, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.78|0.38|0.0216
74001810|NCT03486457|147552217|SUPERIORITY||LS mean difference|2.04|STANDARD_ERROR_OF_MEAN|1.336||0.129|TWO_SIDED|95.0|-0.6|4.67|||Mixed Models Analysis|||Month 1, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.67|-0.60|0.1290
74001811|NCT03486457|147552217|SUPERIORITY||LS mean difference|1.91|STANDARD_ERROR_OF_MEAN|1.172||0.1043|TWO_SIDED|95.0|-0.4|4.22|||Mixed Models Analysis|||Month 1, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.22|-0.40|0.1043
74001812|NCT03486457|147552217|SUPERIORITY||LS mean difference|3.77|STANDARD_ERROR_OF_MEAN|0.763|<|0.0001|TWO_SIDED|95.0|2.26|5.27|||Mixed Models Analysis|||Month 1, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.27|2.26|<0.0001
74001813|NCT03486457|147552217|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.178||0.1318|TWO_SIDED|95.0|-0.54|4.1|||Mixed Models Analysis|||Month 1, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.10|-0.54|0.1318
74001814|NCT03486457|147552217|SUPERIORITY||LS mean difference|2.53|STANDARD_ERROR_OF_MEAN|1.225||0.0402|TWO_SIDED|95.0|0.11|4.95|||Mixed Models Analysis|||Month 3, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.95|0.11|0.0402
74001815|NCT03486457|147552217|SUPERIORITY||LS mean difference|4.41|STANDARD_ERROR_OF_MEAN|1.227||0.0004|TWO_SIDED|95.0|1.99|6.83|||Mixed Models Analysis|||Month 3, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.83|1.99|0.0004
74090862|NCT03456960|147735900|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0281|||||TWO_SIDED|90.0|-0.1662|0.11||||||||0.1100|-0.1662|
74001816|NCT03486457|147552217|SUPERIORITY||LS mean difference|5.29|STANDARD_ERROR_OF_MEAN|1.069|<|0.0001|TWO_SIDED|95.0|3.18|7.4|||Mixed Models Analysis|||Month 3, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.40|3.18|<0.0001
74001817|NCT03486457|147552217|SUPERIORITY||LS mean difference|5.28|STANDARD_ERROR_OF_MEAN|1.261|<|0.0001|TWO_SIDED|95.0|2.79|7.76|||Mixed Models Analysis|||Month 3, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.76|2.79|<0.0001
74001818|NCT03486457|147552217|SUPERIORITY||LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.366||0.1254|TWO_SIDED|95.0|-0.59|4.8|||Mixed Models Analysis|||Month 3, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.80|-0.59|0.1254
74001819|NCT03486457|147552217|SUPERIORITY||LS mean difference|4.34|STANDARD_ERROR_OF_MEAN|1.186||0.0003|TWO_SIDED|95.0|2.0|6.68|||Mixed Models Analysis|||Month 3, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.68|2.00|0.0003
74001820|NCT03486457|147552217|SUPERIORITY||LS mean difference|3.43|STANDARD_ERROR_OF_MEAN|1.384||0.014|TWO_SIDED|95.0|0.7|6.16|||Mixed Models Analysis|||Month 3, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.16|0.70|0.0140
74001821|NCT03486457|147552217|SUPERIORITY||LS mean difference|3.47|STANDARD_ERROR_OF_MEAN|1.268||0.0067|TWO_SIDED|95.0|0.97|5.98|||Mixed Models Analysis|||Month 3, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.98|0.97|0.0067
74001822|NCT03486457|147552217|SUPERIORITY||LS mean difference|4.17|STANDARD_ERROR_OF_MEAN|0.986|<|0.0001|TWO_SIDED|95.0|2.23|6.12|||Mixed Models Analysis|||Month 3, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.12|2.23|<0.0001
74001823|NCT03486457|147552217|SUPERIORITY||LS mean difference|3.27|STANDARD_ERROR_OF_MEAN|1.248||0.0094|TWO_SIDED|95.0|0.81|5.73|||Mixed Models Analysis|||Month 3, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.73|0.81|0.0094
74001824|NCT03486457|147552217|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.049||0.7098|TWO_SIDED|95.0|-1.68|2.46|||Mixed Models Analysis|||Month 6, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.46|-1.68|0.7098
74001825|NCT03486457|147552217|SUPERIORITY||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|1.234||0.4019|TWO_SIDED|95.0|-1.4|3.47|||Mixed Models Analysis|||Month 6, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.47|-1.40|0.4019
74001826|NCT03486457|147552217|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|1.186||0.7537|TWO_SIDED|95.0|-1.97|2.71|||Mixed Models Analysis|||Month 6, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.71|-1.97|0.7537
74037172|NCT00781963|147627633|SUPERIORITY||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|8.2||0.21|TWO_SIDED|95.0|-26.3|5.9|||Mixed Models Analysis||The parameter estimate is the improvement in wake after sleep onset from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||5.9|-26.3|0.21
73877830|NCT03040141|147295353|SUPERIORITY|The null hypothesis was defined as no treatment difference||||||0.778|||||||ANOVA|||||||0.778
74001827|NCT03486457|147552217|SUPERIORITY||LS mean difference|1.22|STANDARD_ERROR_OF_MEAN|1.33||0.3595|TWO_SIDED|95.0|-1.4|3.85|||Mixed Models Analysis|||Month 6, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.85|-1.40|0.3595
74001828|NCT03486457|147552217|SUPERIORITY||LS mean difference|1.99|STANDARD_ERROR_OF_MEAN|1.52||0.1919|TWO_SIDED|95.0|-1.01|4.99|||Mixed Models Analysis|||Month 6, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.99|-1.01|0.1919
74001829|NCT03486457|147552217|SUPERIORITY||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|1.209||0.8163|TWO_SIDED|95.0|-2.1|2.67|||Mixed Models Analysis|||Month 6, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.67|-2.10|0.8163
74001830|NCT03486457|147552217|SUPERIORITY||LS mean difference|2.23|STANDARD_ERROR_OF_MEAN|1.368||0.1048|TWO_SIDED|95.0|-0.47|4.93|||Mixed Models Analysis|||Month 6, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.93|-0.47|0.1048
74001831|NCT03486457|147552217|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.392||0.6118|TWO_SIDED|95.0|-2.04|3.45|||Mixed Models Analysis|||Month 6, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.45|-2.04|0.6118
74001832|NCT03486457|147552217|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.014||0.6996|TWO_SIDED|95.0|-1.61|2.39|||Mixed Models Analysis|||Month 6, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.39|-1.61|0.6996
74001833|NCT03486457|147552217|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.424||0.2122|TWO_SIDED|95.0|-1.03|4.59|||Mixed Models Analysis|||Month 6, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.59|-1.03|0.2122
74037173|NCT00781963|147627634|SUPERIORITY||Mean Difference (Final Values)|-37.0|STANDARD_ERROR_OF_MEAN|12.9||0.004|TWO_SIDED|95.0|-62.2|-11.7|||Mixed Models Analysis||The parameter estimate is the improvement in total wake time from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-11.7|-62.2|0.004
73877831|NCT03040141|147295353|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.94|||||||ANOVA|||||||0.940
73877832|NCT03040141|147295353|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.662|||||||ANOVA|||||||0.662
74001834|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.067||0.0722|TWO_SIDED|95.0|-0.25|0.01|||Mixed Models Analysis|||Month 1, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.25|0.0722
74001835|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.055||0.0035|TWO_SIDED|95.0|-0.27|-0.05|||Mixed Models Analysis|||Month 1, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.05|-0.27|0.0035
74001836|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.069||0.0475|TWO_SIDED|95.0|-0.27|0.0|||Mixed Models Analysis|||Month 1, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.27|0.0475
74001837|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.066||0.0537|TWO_SIDED|95.0|-0.26|0.0|||Mixed Models Analysis|||Month 1, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.26|0.0537
74001838|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.062||0.1977|TWO_SIDED|95.0|-0.2|0.04|||Mixed Models Analysis|||Month 1, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.04|-0.20|0.1977
74001839|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.064||0.0001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed Models Analysis|||Month 3, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.13|-0.38|0.0001
74001840|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.057||0.0018|TWO_SIDED|95.0|-0.29|-0.07|||Mixed Models Analysis|||Month 3, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.07|-0.29|0.0018
74001841|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.47|-0.19|||Mixed Models Analysis|||Month 3, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.19|-0.47|<0.0001
74001842|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.073||0.0002|TWO_SIDED|95.0|-0.42|-0.14|||Mixed Models Analysis|||Month 3, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.14|-0.42|0.0002
74001843|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.063||0.0835|TWO_SIDED|95.0|-0.23|0.01|||Mixed Models Analysis|||Month 3, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.23|0.0835
74001844|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.056||0.0825|TWO_SIDED|95.0|-0.21|0.01|||Mixed Models Analysis|||Month 6, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.21|0.0825
74001845|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.049||0.5616|TWO_SIDED|95.0|-0.13|0.07|||Mixed Models Analysis|||Month 6, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.07|-0.13|0.5616
74001846|NCT03486457|147552218|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.065||0.0748|TWO_SIDED|95.0|-0.24|0.01|||Mixed Models Analysis|||Month 6, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.24|0.0748
74001847|NCT03486457|147552218|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.9477|TWO_SIDED|95.0|-0.15|0.16|||Mixed Models Analysis|||Month 6, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.16|-0.15|0.9477
74001848|NCT03486457|147552218|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.067||0.3829|TWO_SIDED|95.0|-0.07|0.19|||Mixed Models Analysis|||Month 6, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.19|-0.07|0.3829
74001849|NCT03486457|147552219|SUPERIORITY||LS mean difference|6.01|STANDARD_ERROR_OF_MEAN|2.084||0.0044|TWO_SIDED|95.0|1.9|10.12|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||10.12|1.90|0.0044
74001850|NCT03486457|147552219|SUPERIORITY||LS mean difference|10.8|STANDARD_ERROR_OF_MEAN|2.578|<|0.0001|TWO_SIDED|95.0|5.71|15.88|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||15.88|5.71|<0.0001
74001851|NCT03486457|147552219|SUPERIORITY||LS mean difference|0.92|STANDARD_ERROR_OF_MEAN|2.442||0.7062|TWO_SIDED|95.0|-3.9|5.74|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.74|-3.90|0.7062
74001852|NCT03486457|147552220|SUPERIORITY||LS mean difference|0.86|STANDARD_ERROR_OF_MEAN|2.404||0.7228|TWO_SIDED|95.0|-3.92|5.63|||Mixed Models Analysis|||Month 3, Work Time Missed: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.63|-3.92|0.7228
74001853|NCT03486457|147552220|SUPERIORITY||LS mean difference|-6.34|STANDARD_ERROR_OF_MEAN|4.561||0.1682|TWO_SIDED|95.0|-15.39|2.72|||Mixed Models Analysis|||Month 3, Impairment While Working: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.72|-15.39|0.1682
74001854|NCT03486457|147552220|SUPERIORITY||LS mean difference|-6.21|STANDARD_ERROR_OF_MEAN|4.707||0.19|TWO_SIDED|95.0|-15.56|3.13|||Mixed Models Analysis|||Month 3, Overall Work Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.13|-15.56|0.1900
74001855|NCT03486457|147552220|SUPERIORITY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|2.581||0.6757|TWO_SIDED|95.0|-6.22|4.05|||Mixed Models Analysis|||Month 6, Work Time Missed: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.05|-6.22|0.6757
74001856|NCT03486457|147552220|SUPERIORITY||LS mean difference|-2.38|STANDARD_ERROR_OF_MEAN|4.905||0.6285|TWO_SIDED|95.0|-12.13|7.37|||Mixed Models Analysis|||Month 6, Impairment While Working: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.37|-12.13|0.6285
74001857|NCT03486457|147552220|SUPERIORITY||LS mean difference|-2.63|STANDARD_ERROR_OF_MEAN|5.333||0.6228|TWO_SIDED|95.0|-13.23|7.97|||Mixed Models Analysis|||Month 6, Overall Work Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.97|-13.23|0.6228
74001858|NCT03486457|147552221|SUPERIORITY||LS mean difference|-12.81|STANDARD_ERROR_OF_MEAN|3.089|<|0.0001|TWO_SIDED|95.0|-18.9|-6.72|||Mixed Models Analysis|||Month 3, Activity Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.72|-18.90|<0.0001
74001859|NCT03486457|147552221|SUPERIORITY||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|3.157||0.7384|TWO_SIDED|95.0|-5.17|7.28|||Mixed Models Analysis|||Month 6, Activity Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.28|-5.17|0.7384
74001860|NCT00372229|147552222|SUPERIORITY_OR_OTHER_LEGACY||Difference|-28.5|STANDARD_ERROR_OF_MEAN|5.45|||TWO_SIDED|96.0|-39.7|-17.3||||||||-17.3|-39.7|
74001861|NCT00372229|147552223|SUPERIORITY_OR_OTHER_LEGACY||Difference|-11.3|STANDARD_ERROR_OF_MEAN|3.83|||TWO_SIDED|96.0|-19.2|-3.4||||||||-3.4|-19.2|
74090863|NCT03456960|147735901|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.015|||||TWO_SIDED|90.0|-0.0448|0.0149||||||||0.0149|-0.0448|
74090864|NCT03456960|147735902|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0195|||||TWO_SIDED|90.0|-0.0676|0.0286||||||||0.0286|-0.0676|
74001862|NCT00372229|147552224|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2509|STANDARD_ERROR_OF_MEAN|0.1838||0.1739|TWO_SIDED|99.0|-0.2271|0.7289|||F-test|||||0.7289|-0.2271|0.1739
74090865|NCT03456960|147735903|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0547|||||TWO_SIDED|90.0|-0.0937|0.2032||||||||0.2032|-0.0937|
74001863|NCT00372229|147552257|OTHER|Descriptive analysis|Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.71|||TWO_SIDED|95.0|-20.2|13.9||||||||13.9|-20.2|
74001864|NCT00372229|147552258|OTHER|Descriptive analysis|Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|6.21|||TWO_SIDED|95.0|-0.1|24.2||||||||24.2|-0.1|
74001865|NCT01878214|147552264|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||||||0.76
74001866|NCT01878214|147552265|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Regression, Logistic|||||||0.79
74001867|NCT01878214|147552266|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Regression, Logistic|||Smoking frequency||||0.63
74001868|NCT01878214|147552266|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Regression, Logistic|||Smoking quantity||||0.30
74001869|NCT01878214|147552267|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Regression, Logistic|||||||0.28
74001870|NCT01878214|147552268|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Regression, Logistic|||Motivation to quit||||0.09
74001871|NCT01878214|147552268|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Logistic|||Thinking about quitting||||0.04
74001872|NCT01415531|147552295|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.3|||<|0.0001|TWO_SIDED|95.0|-7.7|-4.8|||ANCOVA|||||-4.8|-7.7|<0.0001
74008770|NCT03346057|147567664|OTHER||Estimated Difference in percentage|-2.0||||0.73|TWO_SIDED|95.0|-17.8|8.6|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||8.6|-17.8|0.730
74008771|NCT03346057|147567665|OTHER||Estimated Difference in percentage|-14.9||||0.007|TWO_SIDED|95.0|-28.8|-4.0|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-4.0|-28.8|0.007
74008772|NCT03346057|147567665|OTHER||Estimated Difference in percentage|-12.2||||0.036|TWO_SIDED|95.0|-26.1|-0.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-0.8|-26.1|0.036
74008773|NCT03346057|147567665|OTHER||Estimated Difference in percentage|-9.9||||0.158|TWO_SIDED|95.0|-27.6|3.6|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||3.6|-27.6|0.158
74008774|NCT03346057|147567666|OTHER||Estimated Difference in percentage|-0.9||||0.637|TWO_SIDED|95.0|-9.4|4.0|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||4.0|-9.4|0.637
74001873|NCT02344004|147552306|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving culture conversion by Month 6 was analyzed using the Cochran-Mantel-Haenszel test, stratified by smoking status and prior multi-drug regimen. The treatment comparison was tested at two-sided significance level of 0.05. The null hypothesis assumed that culture conversion by Month 6 is independent of treatment, and the alternative hypothesis assumed that culture conversion by Month 6 is associated with treatment.|The final analysis of the primary endpoint, the number of participants achieving culture conversion at by Month 6, was performed after the last participants completed Month 6 and his/her Month 6 sputum culture result was available.|||<0.0001
74001874|NCT02344004|147552307|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74001875|NCT02344004|147552308|SUPERIORITY|||||||0.7804|||||||Mixed Model Repeated Measures (MMRM)|||This was analyzed using a mixed model repeated measures (MMRM) analysis of change from Baseline at Months 4\&6. MMRM included treatment, month, treatment-by-month interaction, combination of smoking status \& prior MDR (4 levels: Yes/Yes, Yes/No, No/Yes, and No/No) as fixed factors, baseline 6MWD as a covariate \& baseline 6MWD-by-month interaction. An unstructured covariance matrix was used for the MMRM.|"* Baseline is defined as the last non-missing value prior to first dose of study drug.~* Statistics were obtained from an mixed-effects model repeated measures (MMRM) model with pattern-mixture modeling of missing values due to dropout, which included treatment, month, the treatment-by-month interaction, and the combination of smoking status and prior multidrug regimen as fixed factors, the baseline 6MWT distance as a covariate and baseline 6MWT distance-by-month interaction. MMRM included postbaseline data through Month 6.~* For baseline, n is the number of participants with a baseline score and at least 1 postbaseline score. For Month 6, n is the number of participants with a baseline score and a postbaseline score at the summarized visit."|||0.7804
74001876|NCT02344004|147552309|SUPERIORITY||Cox Proportional Hazard|3.92|||<|0.0001|TWO_SIDED|95.0|2.01|7.63|||Regression, Cox|||Kaplan Meier estimates for the distribution of time to culture conversion were constructed for treatment arms. The treatment comparison was made using the stratified log rank test for the ITT population. The estimated median time to culture conversion for each treatment arm was not estimable. The time to culture conversion was analyzed using Cox regression model to estimate hazards ratio.||7.63|2.01|<0.0001
74001877|NCT00598273|147552324|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.099|||TWO_SIDED|97.5|-0.19|0.26|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.26|-0.19|
74008775|NCT03346057|147567666|OTHER||Estimated Difference in percentage|-2.1||||0.134|TWO_SIDED|95.0|-10.6|1.5|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||1.5|-10.6|0.134
74008776|NCT03346057|147567666|OTHER||Estimated Difference in percentage|-1.7||||0.577|TWO_SIDED|95.0|-14.7|5.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||5.8|-14.7|0.577
74037174|NCT00781963|147627635|SUPERIORITY||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|2.36||0.005|TWO_SIDED|95.0|2.0|11.3|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||11.3|2.0|.005
74008777|NCT03346057|147567667|OTHER||Estimated Difference in percentage|6.2|||||TWO_SIDED|95.0|-2.6|18.5||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||18.5|-2.6|
74037175|NCT00781963|147627636|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.97||0.15|TWO_SIDED|95.0|-3.3|0.5|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency (from wrist actigraphy) from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||0.5|-3.3|0.15
74037176|NCT00781963|147627637|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.5|-1.3|||Mixed Models Analysis||The parameter estimate is the improvement in PSQI score from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-1.3|-3.5|<.001
74037177|NCT02064205|147627638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.0|STANDARD_DEVIATION|1000.0||0.2918|ONE_SIDED||||||Mixed Models Analysis|||A mixed model was applied to analyze the Energy Intakes (ad libitum lunch and daily) were done one-sided to evaluate the appetite suppressive effect after the pre-load snack (condition C versus D)||||0.2918
74037178|NCT02064205|147627639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109|||||||Mixed Models Analysis|||AUC of hunger scores before preload intake for condition C versus D.||||0.0109
73877833|NCT03040141|147295354|OTHER|||||||0.64|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.640
74037179|NCT02064205|147627640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0216||||||GLP-1|Mixed Models Analysis|||A mixed model was applied to statistically analyze satiety hormones having Conditions and Time as a fixed factor and having Subject, Cohort, and Treatment Day as random factors.||||0.0216
74037180|NCT00680953|147627641|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.343||||0.0001|TWO_SIDED|95.0|0.194|0.606|||Log Rank|||||0.606|0.194|0.0001
74037181|NCT00680953|147627642|SUPERIORITY_OR_OTHER|||||||0.9951|||||||Log Rank|||||||0.9951
74037182|NCT00680953|147627643|SUPERIORITY_OR_OTHER|||||||0.1568|||||||Log Rank|||||||0.1568
74037183|NCT02062463|147627644|OTHER||Odds Ratio (OR)|3.77|||<|0.001|TWO_SIDED|95.0|2.05|6.95||Threshold for significance at 0.05 level.|Chi-squared|||Analysis was performed using a conditional logistic regression model.||6.95|2.05|<0.001
74001878|NCT00598273|147552324|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|97.5|0.04|0.48|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.48|0.04|
74001879|NCT00598273|147552325|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.51|3.1|||Cochran-Mantel-Haenszel|||||3.10|0.51|
74001880|NCT00598273|147552325|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|0.62|3.56|||Cochran-Mantel-Haenszel|||||3.56|0.62|
74001881|NCT00598273|147552326|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.94|1.05|||Cochran-Mantel-Haenszel|||||1.05|0.94|
74001882|NCT00598273|147552326|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.95|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.95|
74001883|NCT00882687|147552348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3235|||||||Wilcoxon rank-sum test|||||||0.3235
74001884|NCT00882687|147552348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9144|||||||Wilcoxon rank-sum test|||||||0.9144
74001885|NCT00882687|147552348|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3324|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.3324
74001886|NCT00882687|147552349|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5846|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.5846
74001887|NCT00882687|147552349|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1493|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.1493
74090866|NCT03456960|147735903|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0654|||||TWO_SIDED|90.0|0.0141|0.1167||||||||0.1167|0.0141|
73877834|NCT03040141|147295354|OTHER|||||||0.775|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.775
74001888|NCT00882687|147552349|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0404|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.0404
74001889|NCT00882687|147552350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0578|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.0578
74001890|NCT00882687|147552350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8988|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.8988
74001891|NCT00882687|147552350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4709
74001892|NCT00882687|147552351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1773|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.1773
74001893|NCT00882687|147552351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4222|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4222
74001894|NCT00882687|147552351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4326|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4326
74001895|NCT02649946|147552354|SUPERIORITY|TLPP evaluated at 6 months post-index procedure to assess if TLPP of COVERA is superior to that of PTA alone, by direct comparison.|||||<|0.001||||||Test successful if the one-side p-value is less than 0.025 and the result is in favor of the COVERA Vascular Covered Stent.|Chi-squared|||"Hypothesis: The (survival) rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) with respect to TLPP through 6 months is greater than that in subjects treated with PTA alone in the treatment of stenoses in the upper extremity venous outflow of subjects dializing with an AV fistula.~Sample size calculation: 238 randomized subjects \[214 evaluable\] will give 92% power with one-sided type 1 error = 0.025."||||<0.001
74001896|NCT02649946|147552355|NON_INFERIORITY|Non-inferiority Farrington and Manning Exact Test is used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025.||||||0.0022|||||||Farrington and Manning|Non-inferiority test with non-inferiority margin of 10%.||"Hypothesis: The safety rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) is non-inferior to the safety rate in subjects treated with PTA alone through 30 days in the treatment of stenotic lesions.~Sample size: 238 randomized subjects \[226 evaluable\] will give 85% power with one-sided type 1 error = 0.025."||||0.0022
74001897|NCT01809002|147552401|NON_INFERIORITY|The primary endpoint tested non-inferiority as compared to collagen nerve cuff and superior to no treatment. Non-inferiority is defined as the lower limit of the 95% CI about the difference of \> -2 and the upper limit of the 95% CI for s2PD for Avance of \< 13 in ITT table.|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.087|1.574|||ANCOVA|||The analysis was performed using a pre-defined standard statistical analysis with a non-response/failure assigned a worst-case scenario value of 16mm.||1.574|-1.087|
74001898|NCT01809002|147552402|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||||||0.035
74001899|NCT01809002|147552402|SUPERIORITY|||||||0.365|||||||Wilcoxon (Mann-Whitney)|||||||0.365
74001900|NCT01809002|147552403|SUPERIORITY|||||||0.915||||||The number and percentage of all treated subjects who recovered s2PD in the target repair at Month 12 (i.e., s2PD of 2 - 15 mm) were summarized by repair type. Differences between the repair types were assessed using a logistic regression analysis.|Regression, Logistic|||Responders were defined as subjects achieving s2PD of 2-15 mm on the target nerve repair.||||0.915
74008778|NCT03346057|147567667|OTHER||Estimated Difference in percentage|0.5|||||TWO_SIDED|95.0|-9.3|13.1||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||13.1|-9.3|
74008779|NCT03346057|147567667|OTHER||Estimated Difference in percentage|2.0|||||TWO_SIDED|95.0|-8.4|17.7||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||17.7|-8.4|
74008780|NCT03346057|147567668|OTHER||Estimated Difference in percentage|5.6|||||TWO_SIDED|95.0|-5.5|14.3||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||14.3|-5.5|
74008781|NCT03346057|147567668|OTHER||Estimated Difference in percentage|1.5|||||TWO_SIDED|95.0|-9.2|9.3||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||9.3|-9.2|
74001901|NCT01809002|147552404|SUPERIORITY||LS Means difference|-2.84|||||TWO_SIDED|95.0|-11.6316|5.9541||Pre-injury baseline was defined as s2PD in the contralateral digit associated with the target digit.|ANCOVA|This analysis was assessed in the ITT population, at Month 12 using the LS Mean differences from a repeated measures ANCOVA model.||||5.9541|-11.6316|
74001902|NCT01809002|147552405|SUPERIORITY|||||||0.792|||||||Kaplan-Meier median and 95% CI|Differences between the repair types were assessed with a KM log-rank test that was appropriate for the handing of interval-censored data.||||||0.792
74001903|NCT01809002|147552406|SUPERIORITY|||||||0.526|||||||Wilcoxon (Mann-Whitney)|This analysis was completed to detect a distribution shift of the MRCC score between repairs with PNA and repairs with nerve cuff at Month 12.||||||0.526
74001904|NCT01809002|147552407|OTHER||Mean Difference (Final Values)|-24.09|||||TWO_SIDED|||||||||"This analysis compares the change in 12 Month Pain VAS scores from Baseline. Missing or incomplete data was extrapolated using a pre-defined repeated measures modeling approach for calculations in this analysis.~This analysis assesses each treatment group for clinically meaningful improvement in VAS from Baseline assuming a Meaningful Clinically Important Difference delta of 20 points (mm)."||||
74001905|NCT01809002|147552409|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
74001906|NCT01809002|147552410|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|This analysis was completed utilizing a one-sided Wilcoxon Rank Sum test.||||||0.037
74001907|NCT01809002|147552411|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|One-sided Wilcoxon Rank Sum test was utilized for this analysis.||||||0.021
74001908|NCT02318797|147552443|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment by time interaction test||||<0.0001
74001909|NCT02318797|147552443|SUPERIORITY|||||||0.0019|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.0019
74001910|NCT02318797|147552444|SUPERIORITY|||||||0.4103|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.4103
74001911|NCT02318797|147552444|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
74001912|NCT02318797|147552444|SUPERIORITY|||||||0.4068|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.4068
74001913|NCT02318797|147552444|SUPERIORITY|||||||0.2656|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.2656
74001914|NCT02318797|147552445|SUPERIORITY|||||||0.4582|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.4582
74001915|NCT02318797|147552445|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
74001916|NCT02318797|147552445|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.05
73877835|NCT03040141|147295354|OTHER|||||||0.701|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.701
73877836|NCT03040141|147295354|OTHER|||||||0.638|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.638
73877837|NCT03040141|147295355|OTHER|||||||0.127|||||||Regression, Logistic|||||||0.127
74001917|NCT02318797|147552445|SUPERIORITY|||||||0.1792|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.1792
74001918|NCT02318797|147552446|SUPERIORITY|||||||0.2179|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.2179
74001919|NCT02318797|147552446|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
74001920|NCT02318797|147552446|SUPERIORITY|||||||0.4797|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.4797
74001921|NCT02318797|147552446|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.0014
74001922|NCT02318797|147552447|SUPERIORITY|||||||0.0058|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.0058
74001923|NCT02318797|147552448|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.0014
74001924|NCT02318797|147552449|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0001
74001925|NCT02318797|147552450|SUPERIORITY|||||||0.5566|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.5566
74001926|NCT02318797|147552450|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||<0.0001
74001927|NCT02318797|147552451|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.002
74001928|NCT02318797|147552452|SUPERIORITY|||||||0.0029|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0029
74001929|NCT02318797|147552453|SUPERIORITY|||||||0.0021|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0021
74001930|NCT02318797|147552454|SUPERIORITY|||||||0.1183|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.1183
74001931|NCT02318797|147552454|SUPERIORITY|||||||0.0569|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.0569
74001932|NCT02318797|147552455|SUPERIORITY|||||||0.0745|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0745
74001933|NCT02318797|147552455|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||<0.0001
74001934|NCT02318797|147552456|SUPERIORITY|||||||0.1653|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.1653
74001935|NCT02318797|147552456|SUPERIORITY|||||||0.1772|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.1772
74001936|NCT02318797|147552457|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction||||<0.0001
73877838|NCT03040141|147295355|OTHER|||||||1|||||||Regression, Logistic|||||||1.000
74001937|NCT02318797|147552458|SUPERIORITY|||||||0.0202|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0202
74001938|NCT02318797|147552459|SUPERIORITY|||||||0.4715|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.4715
74001939|NCT02318797|147552459|SUPERIORITY|||||||0.9209|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.9209
74001940|NCT04217590|147552516|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|1.9|15.12|||Fisher Exact||The CI for OR is calculated as an exact CI. An OR \> 1 favours SZC.|||15.12|1.90|<0.001
74001941|NCT04217590|147552517|SUPERIORITY||Odds Ratio (OR)|6.41|||<|0.001|TWO_SIDED|95.0|2.64|15.55|||Regression, Logistic|The OR, 95% CI and p-value are obtained from a pooled logistic regression model after multiple imputation (MI) of missing pre-dialysis S-K values.|An OR \> 1 favours SZC.|||15.55|2.64|<0.001
74001942|NCT04217590|147552518|SUPERIORITY||Odds Ratio (OR)|6.41|||<|0.001|TWO_SIDED|95.0|2.71|15.12|||Regression, Logistic|The OR, 95% CI and p-value are obtained from a pooled logistic regression model after multiple imputation (MI) of missing pre-dialysis S-K values.|An OR \> 1 favours SZC.|||15.12|2.71|<0.001
74001943|NCT04217590|147552519|SUPERIORITY||Odds Ratio (OR)|4.41|||<|0.001|TWO_SIDED|95.0|2.53|7.67|||Generalised linear mixed model (GLMM)|The p-value was obtained from a test of equality of odds ratios.|The OR was obtained from GLMM model with random intercept and logit link. Treatment, visit, visit by treatment interaction and baseline were specified as fixed effects. An OR \> 1 favours SZC.|||7.67|2.53|<0.001
74001944|NCT04217590|147552520|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|0.77|1.64|||||Endpoint analysed with Generalised linear mixed model. The CI for the mean difference was calculated by bootstrapping. A mean difference \> 0 favours SZC.|||1.64|0.77|
74001945|NCT04217590|147552521|SUPERIORITY||Odds Ratio (OR)|5.82|||<|0.001|TWO_SIDED|95.0|3.15|10.73|||Generalised linear mixed model (GLMM)|The p-value was obtained from a test of equality of odds ratios.|The OR was obtained from GLMM model with random intercept and logit link. Treatment, visit, visit by treatment interaction and baseline were specified as fixed effects. An OR \> 1 favours SZC.|||10.73|3.15|<0.001
74001946|NCT00704405|147552524|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|53.6|||<|0.001|TWO_SIDED|95.0|34.5|69.1|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||69.1|34.5|<0.001
74001947|NCT00704405|147552524|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|64.4|||<|0.001|TWO_SIDED|95.0|45.2|78.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||78.3|45.2|<0.001
74001948|NCT00704405|147552524|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|59.0|||<|0.001|TWO_SIDED|95.0|40.2|73.4|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||73.4|40.2|<0.001
74001949|NCT00704405|147552527|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|47.3|||<|0.001|TWO_SIDED|95.0|29.2|63.2|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||63.2|29.2|<0.001
74001950|NCT00704405|147552528|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|82.6|||||TWO_SIDED|95.0|69.5|90.2|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.|||90.2|69.5|
73877839|NCT03040141|147295355|OTHER|||||||0.458|||||||Regression, Logistic|||||||0.458
74001951|NCT00704405|147552528|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|76.1|||||TWO_SIDED|95.0|60.1|86.7|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.|||86.7|60.1|
74001952|NCT00704405|147552529|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|35.8|||||TWO_SIDED|95.0|15.5|53.4|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO patients (36.6%) with undetectable HCV RNA at Week 48 and stratifies by prior treatment response.|||53.4|15.5|
74001953|NCT01395888|147552530|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.259||||0.484|TWO_SIDED|95.0|-0.468|0.986|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.986|-0.468|0.484
74001954|NCT03218397|147552531|SUPERIORITY||Difference in means|5.6||||0.013|TWO_SIDED|95.0|1.2|10.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic modification (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||10|1.2|0.013
74001955|NCT03218397|147552532|SUPERIORITY|||||||0.265||||||alpha = 0.05|Fisher Exact|||||||0.265
74001956|NCT03218397|147552533|SUPERIORITY|||||||0.093||||||alpha = 0.05|t-test, 2 sided|T-test for the difference in mean length of stay (days) between treatment arms among subjects alive at 30 days.||||||0.093
74001957|NCT03218397|147552534|SUPERIORITY|||||||0.014||||||alpha = 0.05|Fisher Exact|||||||0.014
74001958|NCT03218397|147552535|SUPERIORITY||Difference in means|7.5||||0.009|TWO_SIDED|95.0|1.9|13.1||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||13.1|1.9|0.009
74001959|NCT03218397|147552536|SUPERIORITY||Difference in means|6.5||||0.022|TWO_SIDED|95.0|0.9|12.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||12.0|0.9|0.022
74001960|NCT03218397|147552537|SUPERIORITY||Difference in means|0.7||||0.46|TWO_SIDED|95.0|-1.2|2.7||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||2.7|-1.2|0.46
74001961|NCT03218397|147552538|SUPERIORITY||Difference in means|4.6||||0.074|TWO_SIDED|95.0|-0.4|9.6||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||9.6|-0.4|0.074
74008782|NCT03346057|147567668|OTHER||Estimated Difference in percentage|0.9|||||TWO_SIDED|95.0|-15.1|12.7||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||12.7|-15.1|
73877840|NCT03040141|147295355|OTHER|||||||0.127|||||||Regression, Logistic|||||||0.127
73877841|NCT03040141|147295356|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.371|||||||ANOVA|||||||0.371
74037184|NCT02062463|147627645|OTHER||Odds Ratio (OR)|1.26||||0.316|TWO_SIDED|95.0|0.8|1.98||Threshold for significance at 0.05 level.|Chi-squared|||Analysis was performed using a conditional logistic regression model.||1.98|0.80|0.316
74037185|NCT04124692|147627666|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74037186|NCT04124692|147627667|SUPERIORITY||||||=|0.0043|||||||Fisher Exact|||||||= 0.0043
74037187|NCT04124692|147627667|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74037188|NCT00205699|147627688|SUPERIORITY||||||<|0.0001||||||The p value refers to the time by treatment condition interaction. The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA % fat used a likelihood-based mixed-effects model using time (0, 6 and 12 weeks) and medication group as independent variables, with Toeplitz covariance structure specified, based on Bayesian information criteria (BIC). The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).||||<0.0001
74037189|NCT00205699|147627689|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
74037190|NCT00205699|147627690|SUPERIORITY|||||||0.27|||||||ANCOVA|||||||0.27
74037191|NCT00205699|147627691|SUPERIORITY|||||||0.17|||||||ANCOVA|||||||0.17
74037192|NCT00205699|147627692|SUPERIORITY|||||||0.29|||||||ANCOVA|||||||0.29
74037193|NCT00205699|147627693|SUPERIORITY||||||<|0.003|||||||ANCOVA|||Repeated measures ANCOVA was used to test for the main effect of time on the outcome, and to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).||||<0.003
74037194|NCT00205699|147627693|SUPERIORITY|||||||0.003||||||Bonferroni correction for multiple comparisons was applied (p\<0.05/4 = 0.0125).|Contrast|Contrasts based on the ANCOVA-derived time by treatment condition interaction.||||||0.003
73877842|NCT03040141|147295356|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.735|||||||ANOVA|||||||0.735
74037195|NCT00205699|147627693|SUPERIORITY|||||||0.002||||||Bonferroni correction for multiple comparisons was applied (p\<0.05/4 = 0.0125).|ANCOVA|Contrasts based on the ANCOVA-derived time by treatment condition interaction.||||||0.002
74037196|NCT01122030|147627702|SUPERIORITY_OR_OTHER|||||||0.0767||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.0767
73877843|NCT03040141|147295356|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.476|||||||ANOVA|||||||0.476
73877844|NCT03040141|147295356|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.581|||||||ANOVA|||||||0.581
73877845|NCT03040141|147295357|OTHER|||||||0.98|||||||Regression, Logistic|||||||0.980
74037197|NCT01122030|147627702|SUPERIORITY_OR_OTHER|||||||0.8727||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.8727
74037198|NCT01122030|147627702|SUPERIORITY_OR_OTHER|||||||0.6373||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.6373
74037199|NCT01122030|147627702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
74037200|NCT01122030|147627702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
74037201|NCT01122030|147627702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
74037202|NCT01122030|147627703|SUPERIORITY_OR_OTHER|||||||0.8982||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.8982
74037203|NCT01122030|147627703|SUPERIORITY_OR_OTHER|||||||0.4946||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.4946
74037204|NCT01122030|147627703|SUPERIORITY_OR_OTHER|||||||0.9301||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.9301
74037205|NCT01122030|147627703|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.0047
74037206|NCT01122030|147627703|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
74037207|NCT01122030|147627703|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
74037208|NCT01122030|147627704|SUPERIORITY_OR_OTHER|||||||0.1334||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.1334
74037209|NCT01122030|147627704|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.3320
74037210|NCT01122030|147627704|SUPERIORITY_OR_OTHER|||||||0.9371||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.9371
74037211|NCT01122030|147627704|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.0002
74037212|NCT01122030|147627704|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
74001962|NCT03218397|147552539|SUPERIORITY||Difference in means|6.5||||0.008|TWO_SIDED|95.0|1.7|11.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||11.2|1.7|0.008
74001963|NCT03218397|147552540|SUPERIORITY||Difference in means|-1.9||||0.37|TWO_SIDED|95.0|-5.9|2.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||2.2|-5.9|0.37
74001964|NCT02641496|147552573|OTHER|ANOVA||||||0.027||||||Significance threshold p\<0.05; one-tailed|ANOVA|||Treatment 1 to Treatment 4 (approximately first 30 days of treatment)||||0.027
74001965|NCT02641496|147552573|OTHER|ANOVA||||||0.919||||||Significance threshold p\<0.05; one-tailed|ANOVA|||Last 30 Days of 1 Year Study||||0.919
74001966|NCT02641496|147552574|OTHER|||||||0.696||||||Significance threshold p\<0.05; one-tailed|ANOVA|||||||0.696
74001967|NCT02641496|147552575|OTHER|||||||0.593||||||Significance threshold p\<0.05; two-tailed|ANOVA|||||||0.593
74001968|NCT02641496|147552576|OTHER|||||||0.925||||||Significance threshold p\<0.05; one-tailed|ANOVA|||||||0.925
73877846|NCT03040141|147295357|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
74001969|NCT00112047|147552610|NON_INFERIORITY_OR_EQUIVALENCE|Assuming 70% response rate for each group at Week 48, 500 participants (250 per group) were sufficient to achieve at least 85% power to establish non-inferiority between the 2 study groups with a delta of 13%. The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|11.4||||0.002|TWO_SIDED|95.0|4.3|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||18.6|4.3|0.002
74001970|NCT00112047|147552611|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|9.1||||0.021|TWO_SIDED|95.0|1.6|16.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||16.6|1.6|0.021
74001971|NCT00112047|147552612|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|11.2||||0.004|TWO_SIDED|95.0|3.7|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made||Null hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||18.6|3.7|0.004
74001972|NCT00112047|147552613|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|7.9||||0.058|TWO_SIDED|95.0|0.1|15.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||15.6|0.1|0.058
74001973|NCT00112047|147552614|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.||||0.003
74001974|NCT00112047|147552615|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.||||0.046
74037213|NCT01122030|147627704|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
73877847|NCT03040141|147295357|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
73877848|NCT03040141|147295357|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
73877849|NCT03040141|147295358|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.695|||||||ANOVA|||||||0.695
74001975|NCT00112047|147552616|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is different between the 2 treatment groups.||||0.026
74001976|NCT00112047|147552617|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are different.||||0.063
74001977|NCT00112047|147552618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.31|TWO_SIDED|95.0|-0.16|0.06||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum-weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.06|-0.16|0.31
74001978|NCT00112047|147552619|SUPERIORITY_OR_OTHER||stratum-weighted difference|31.74||||0.002||95.0|8.96|54.52||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||54.52|8.96|0.002
74001979|NCT00112047|147552620|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|12.7||||0.004|TWO_SIDED|95.0|4.3|21.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||21.1|4.3|0.004
74001980|NCT00112047|147552621|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|6.4||||0.158|TWO_SIDED|95.0|-2.3|15.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||15.0|-2.3|0.158
74001981|NCT00112047|147552622|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: Ther percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.003
74001982|NCT00112047|147552623|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.124
74008783|NCT03346057|147567669|OTHER||Estimated Difference in percentage|-2.1|||||TWO_SIDED|95.0|-11.8|3.8||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 2 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||3.8|-11.8|
74008784|NCT03346057|147567669|OTHER||Estimated Difference in percentage|1.8|||||TWO_SIDED|95.0|-8.1|8.4||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 4 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||8.4|-8.1|
74008785|NCT03346057|147567669|OTHER||Estimated Difference in percentage|1.1|||||TWO_SIDED|95.0|-13.5|11.1||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 16 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||11.1|-13.5|
73877850|NCT03040141|147295358|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.542|||||||ANOVA|||||||0.542
73877851|NCT03040141|147295358|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.899|||||||ANOVA|||||||0.899
74001983|NCT00112047|147552624|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is different between the 2 treatment groups.||||0.025
74001984|NCT00112047|147552625|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.41
74001985|NCT00112047|147552626|SUPERIORITY_OR_OTHER||stratum-weighted difference|-0.05||||0.45||95.0|-0.17|0.08||The change from baseline to Week 96 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.08|-0.17|0.45
74001986|NCT00112047|147552627|SUPERIORITY_OR_OTHER||stratum-weighted difference|32.93||||0.036||95.0|0.87|64.99||The change from baseline to Week 96 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||64.99|0.87|0.036
74001987|NCT00112047|147552628|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The change from Week 48 to Week 96 in limb fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum Test|No other adjustments were made.||Null Hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are not equal||||<0.001
74001988|NCT00112047|147552629|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.025
74001989|NCT00112047|147552630|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||<0.001
74001990|NCT00112047|147552631|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|12.9||||0.004|TWO_SIDED|95.0|4.2|21.6||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||21.6|4.2|0.004
74001991|NCT00112047|147552632|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|8.1||||0.082|TWO_SIDED|95.0|-0.8|17.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||17.0|-0.8|0.082
73877852|NCT03040141|147295358|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.321|||||||ANOVA|||||||0.321
73877853|NCT03040141|147295359|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.663|||||||ANOVA|||||||0.663
73877854|NCT03040141|147295359|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.54|||||||ANOVA|||||||0.540
73877855|NCT03040141|147295359|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.918|||||||ANOVA|||||||0.918
74001992|NCT00112047|147552633|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|11.6||||0.009||95.0|3.1|20.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null Hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||20.1|3.1|0.009
74001993|NCT00112047|147552634|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|10.4||||0.019|TWO_SIDED|95.0|1.8|19.0||The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||19.0|1.8|0.019
74001994|NCT00112047|147552635|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of loss of virological response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.003
74001995|NCT00112047|147552636|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.056
74001996|NCT00112047|147552637|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is different between the 2 treatment groups||||0.066
74001997|NCT00112047|147552638|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is different between the 2 treatment groups||||0.30
74001998|NCT00112047|147552639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.39|TWO_SIDED|95.0|-0.16|0.08||The change from baseline to Week 144 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.08|-0.16|0.39
74001999|NCT00112047|147552640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|41.3||||0.089|TWO_SIDED|95.0|4.05|78.55||The change from baseline to Week 144 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline toWeek 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||78.55|4.05|0.089
74002000|NCT00112047|147552641|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.001
74002001|NCT00112047|147552642|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.011
74002002|NCT00112047|147552643|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||<0.001
74002003|NCT00112047|147552653|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is not equal to zero.||||0.16
74090867|NCT03456960|147735904|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.146|||||TWO_SIDED|90.0|-0.2478|-0.0443||||||||-0.0443|-0.2478|
73877856|NCT03040141|147295359|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.294|||||||ANOVA|||||||0.294
74002004|NCT00112047|147552654|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is not equal to zero.||||0.049
74002005|NCT00112047|147552655|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is not equal to zero.||||0.055
74002006|NCT00112047|147552656|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||<0.001
74002007|NCT00112047|147552657|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.12
74002008|NCT00112047|147552658|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.037
74002009|NCT00112047|147552659|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.013
74002010|NCT00112047|147552660|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||"The number and proportion of participants in each category (bothers, does not bother) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.70
74002011|NCT00112047|147552661|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||P-value is from the Wilcoxon Signed Rank Test.|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.95
74002012|NCT00112047|147552662|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||P-value is from the Wilcoxon Signed Rank Test|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.23
74002013|NCT02502097|147552676|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.5||||0.5096|TWO_SIDED|95.0|-10.1|5.1|||Mixed Models Analysis||LS mean difference Day 7|||5.1|-10.1|0.5096
74002014|NCT02502097|147552676|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-0.8||||0.8983|TWO_SIDED|95.0|-13.4|11.8|||Mixed Models Analysis||LS mean difference Day 14|||11.8|-13.4|0.8983
74008786|NCT03044886|147567670|SUPERIORITY|||||||0.576|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.576
74008787|NCT03044886|147567671|SUPERIORITY|||||||0.489|||||||ANOVA|||||||0.489
74008788|NCT03044886|147567672|SUPERIORITY|||||||0.042|||||||ANOVA|||||||0.042
74008789|NCT03044886|147567672|SUPERIORITY|||||||0.041|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.041
74008790|NCT03044886|147567673|SUPERIORITY|||||||0.71|||||||ANCOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.710
74008791|NCT03044886|147567674|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.340
74008792|NCT03044886|147567675|SUPERIORITY|||||||0.048|||||||ANOVA|||||||0.048
74008793|NCT03044886|147567675|SUPERIORITY|||||||0.038|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.038
73877857|NCT03040141|147295361|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.25|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.250
74002015|NCT02502097|147552680|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-3.7||||0.5005|TWO_SIDED|95.0|-14.6|7.2|||Mixed Models Analysis||LS means difference Day 7|||7.2|-14.6|0.5005
74002016|NCT02502097|147552680|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.8||||0.8382|TWO_SIDED|95.0|-19.8|16.1|||Mixed Models Analysis||LS means difference Day 14|||16.1|-19.8|0.8382
74002017|NCT02502097|147552681|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.3||||0.8008|TWO_SIDED|95.0|-11.9|9.2|||Mixed Models Analysis||LS means difference Day 7|||9.2|-11.9|0.8008
74002018|NCT02502097|147552681|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|0.2||||0.9805|TWO_SIDED|95.0|-17.6|18.0|||Mixed Models Analysis||LS means difference Day 14|||18.0|-17.6|0.9805
74002019|NCT02502097|147552684|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.4||||0.3279|TWO_SIDED|95.0|-7.1|2.4|||Mixed Models Analysis||LS means difference Day 7|||2.4|-7.1|0.3279
74002020|NCT02502097|147552684|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|1.5||||0.7772|TWO_SIDED|95.0|-9.2|12.3|||Mixed Models Analysis||LS means difference Day 14|||12.3|-9.2|0.7772
74002021|NCT02502097|147552685|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-3.2||||0.3493|TWO_SIDED|95.0|-10.1|3.6|||Mixed Models Analysis||LS means difference Day 7|||3.6|-10.1|0.3493
74002022|NCT02502097|147552685|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|1.0||||0.8952|TWO_SIDED|95.0|-14.3|16.3|||Mixed Models Analysis||LS means difference Day 14|||16.3|-14.3|0.8952
74002023|NCT02502097|147552686|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.5||||0.6597|TWO_SIDED|95.0|-8.1|5.2|||Mixed Models Analysis||LS means difference Day 7|||5.2|-8.1|0.6597
74002024|NCT02502097|147552686|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|2.1||||0.788|TWO_SIDED|95.0|-13.1|17.2|||Mixed Models Analysis||LS means difference Day 14|||17.2|-13.1|0.7880
73877858|NCT03040141|147295361|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.133|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.133
74002025|NCT02502097|147552690|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.5||||0.1856|TWO_SIDED|95.0|-6.3|1.3|||Mixed Models Analysis||LS mean difference Day 7|||1.3|-6.3|0.1856
74002026|NCT02502097|147552690|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|2.7||||0.5658|TWO_SIDED|95.0|-6.6|12.1|||Mixed Models Analysis||LS mean difference Day 14|||12.1|-6.6|0.5658
74002027|NCT02502097|147552691|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-8.0||||0.0847|TWO_SIDED|95.0|-17.2|1.1|||Mixed Models Analysis||LS mean difference Day 7|||1.1|-17.2|0.0847
74002028|NCT02502097|147552691|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-5.8||||0.3083|TWO_SIDED|95.0|-17.0|5.4|||Mixed Models Analysis||LS mean difference Day 14|||5.4|-17.0|0.3083
74002029|NCT02502097|147552692|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.0||||0.229|TWO_SIDED|95.0|-5.3|1.3|||Mixed Models Analysis||LS mean difference Day 7|||1.3|-5.3|0.2290
73877859|NCT03040141|147295361|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.177|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.177
74002030|NCT02502097|147552692|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|0.0||||0.9794|TWO_SIDED|95.0|-3.5|3.4|||Mixed Models Analysis||LS mean difference Day 14|||3.4|-3.5|0.9794
74002031|NCT02502097|147552693|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.0||||0.0009|TWO_SIDED|95.0|-1.5|-0.4|||Mixed Models Analysis||LS mean difference Week 1|||-0.4|-1.5|0.0009
74002032|NCT02502097|147552693|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.0||||0.005|TWO_SIDED|95.0|-1.7|-0.3|||Mixed Models Analysis||LS mean difference Week 2|||-0.3|-1.7|0.0050
74002033|NCT02502097|147552694|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.8||||0.2938|TWO_SIDED|95.0|-8.2|2.5|||Mixed Models Analysis||LS mean difference Day 7|||2.5|-8.2|0.2938
74002034|NCT02502097|147552694|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-4.0||||0.1319|TWO_SIDED|95.0|-9.2|1.2|||Mixed Models Analysis||LS mean difference Day 14|||1.2|-9.2|0.1319
74002035|NCT02502097|147552695|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.2175|TWO_SIDED|95.0|-1.5|0.4|||Mixed Models Analysis||LS mean difference Day 7|||0.4|-1.5|0.2175
74002036|NCT02502097|147552695|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.5312|TWO_SIDED|95.0|-1.4|0.7|||Mixed Models Analysis||LS mean difference Day 14|||0.7|-1.4|0.5312
74002037|NCT00252733|147552723|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.821||||0.0508|TWO_SIDED|95.0|0.673|1.001|||Log Rank|Generalized||||1.001|0.673|0.0508
74002038|NCT03310268|147552733|OTHER||Difference of Least Square mean|0.19|STANDARD_ERROR_OF_MEAN|0.094||0.0476|TWO_SIDED|95.0|0.002|0.374|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.374|0.002|0.0476
74002039|NCT03310268|147552733|OTHER||Difference of Least Square mean|-0.02|STANDARD_ERROR_OF_MEAN|0.093||0.8411|TWO_SIDED|95.0|-0.202|0.164|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.164|-0.202|0.8411
74002040|NCT03310268|147552733|OTHER||Difference of Least Square mean|0.21|STANDARD_ERROR_OF_MEAN|0.094||0.0298|TWO_SIDED|95.0|0.02|0.393|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.393|0.020|0.0298
74002041|NCT03310268|147552734|OTHER||Difference of Least Square mean|-7.2|STANDARD_ERROR_OF_MEAN|4.649||0.1232|TWO_SIDED|95.0|-16.376|1.975|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||1.975|-16.376|0.1232
74002042|NCT03310268|147552734|OTHER||Difference of Least Square mean|-4.04|STANDARD_ERROR_OF_MEAN|4.588||0.3793|TWO_SIDED|95.0|-13.099|5.011|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||5.011|-13.099|0.3793
74002043|NCT03310268|147552734|OTHER||Difference of Least Square mean|-3.16|STANDARD_ERROR_OF_MEAN|4.648||0.4979|TWO_SIDED|95.0|-12.33|6.017|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||6.017|-12.330|0.4979
74002044|NCT00706433|147552747|SUPERIORITY_OR_OTHER|||||||0.768||95.0|||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments||||0.7680
74002045|NCT00706433|147552748|SUPERIORITY_OR_OTHER|||||||0.7975||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.||||0.7975
74002046|NCT00706433|147552749|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments||||>0.10
74002047|NCT00706433|147552750|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments||||>0.10
74002048|NCT00706433|147552752|SUPERIORITY_OR_OTHER|||||||0.1103||95.0|||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments||||0.1103
74002049|NCT00706433|147552753|SUPERIORITY_OR_OTHER|||||||0.7228||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.||||0.7228
74002050|NCT00706433|147552754|SUPERIORITY_OR_OTHER|||||||0.3416||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates||||0.3416
74002051|NCT00706433|147552755|SUPERIORITY_OR_OTHER|||||||0.5759||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5759
74002052|NCT00706433|147552756|SUPERIORITY_OR_OTHER|||||||0.4754||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4754
74002053|NCT00706433|147552757|SUPERIORITY_OR_OTHER|||||||0.4096||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4096
74002054|NCT00706433|147552758|SUPERIORITY_OR_OTHER|||||||0.5812||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5812
74002055|NCT00706433|147552759|SUPERIORITY_OR_OTHER|||||||0.8679||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8679
74002056|NCT00706433|147552760|SUPERIORITY_OR_OTHER|||||||0.3666||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3666
74002057|NCT00706433|147552761|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3080
74002058|NCT00706433|147552762|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002059|NCT00706433|147552763|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002060|NCT00706433|147552764|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002061|NCT00706433|147552765|SUPERIORITY_OR_OTHER|||||||0.3916||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3916
74002062|NCT00706433|147552766|SUPERIORITY_OR_OTHER|||||||0.8387||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8387
74002063|NCT00706433|147552767|SUPERIORITY_OR_OTHER|||||||0.1489||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1489
74002064|NCT00706433|147552768|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
74002065|NCT00706433|147552768|SUPERIORITY_OR_OTHER|||||||0.4143||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4143
74002066|NCT00706433|147552768|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0005
74002067|NCT00706433|147552768|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0003
74002068|NCT00706433|147552768|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
74002069|NCT00706433|147552768|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
74002070|NCT00706433|147552768|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9700
74002071|NCT00706433|147552769|SUPERIORITY_OR_OTHER|||||||0.2544||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2544
74002072|NCT00706433|147552770|SUPERIORITY_OR_OTHER|||||||0.4321||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4321
74002073|NCT00706433|147552771|SUPERIORITY_OR_OTHER|||||||0.0317||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0317
74002074|NCT00706433|147552771|SUPERIORITY_OR_OTHER|||||||0.5818||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5818
74002075|NCT00706433|147552771|SUPERIORITY_OR_OTHER|||||||0.0395||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0395
74002076|NCT00706433|147552771|SUPERIORITY_OR_OTHER|||||||0.7426||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7426
74002077|NCT00706433|147552771|SUPERIORITY_OR_OTHER|||||||0.0029||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0029
74002078|NCT00706433|147552771|SUPERIORITY_OR_OTHER|||||||0.2142||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2142
74002079|NCT00706433|147552771|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0781
74090868|NCT03456960|147735904|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1674|||||TWO_SIDED|90.0|-0.2084|-0.1264||||||||-0.1264|-0.2084|
74090869|NCT03456960|147735905|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1193|||||TWO_SIDED|90.0|-0.2179|-0.0206||||||||-0.0206|-0.2179|
74090870|NCT03456960|147735905|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1366|||||TWO_SIDED|90.0|-0.173|-0.1002||||||||-0.1002|-0.1730|
73877860|NCT03040141|147295361|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.36|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.360
74002080|NCT00706433|147552772|SUPERIORITY_OR_OTHER|||||||0.9886||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9886
74002081|NCT00706433|147552773|SUPERIORITY_OR_OTHER|||||||0.6907||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6907
74002082|NCT00706433|147552774|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0047
74002083|NCT00706433|147552774|SUPERIORITY_OR_OTHER|||||||0.6116||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6116
74002084|NCT00706433|147552774|SUPERIORITY_OR_OTHER|||||||0.0209||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0209
74002085|NCT00706433|147552774|SUPERIORITY_OR_OTHER|||||||0.0513||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0513
74002086|NCT00706433|147552774|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0019
74002087|NCT00706433|147552774|SUPERIORITY_OR_OTHER|||||||0.0089||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0089
74002088|NCT00706433|147552774|SUPERIORITY_OR_OTHER|||||||0.526||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5260
74002089|NCT00706433|147552775|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7820
74002090|NCT00706433|147552776|SUPERIORITY_OR_OTHER|||||||0.4965||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4965
74002091|NCT00706433|147552777|SUPERIORITY_OR_OTHER|||||||0.0728||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0728
74002092|NCT00706433|147552778|SUPERIORITY_OR_OTHER|||||||0.548||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5480
74002093|NCT00706433|147552779|SUPERIORITY_OR_OTHER|||||||0.0301||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0301
73877861|NCT03040141|147295362|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.636|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.636
74002094|NCT00706433|147552779|SUPERIORITY_OR_OTHER|||||||0.0564||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0564
74002095|NCT00706433|147552779|SUPERIORITY_OR_OTHER|||||||0.447||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4470
74002096|NCT00706433|147552779|SUPERIORITY_OR_OTHER|||||||0.2804||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2804
74002097|NCT00706433|147552779|SUPERIORITY_OR_OTHER|||||||0.1835||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1835
74002098|NCT00706433|147552779|SUPERIORITY_OR_OTHER|||||||0.0103||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0103
74002099|NCT00706433|147552779|SUPERIORITY_OR_OTHER|||||||0.1319||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1319
74002100|NCT00706433|147552780|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002101|NCT00706433|147552781|SUPERIORITY_OR_OTHER|||||||0.4378||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4378
74002102|NCT00706433|147552782|SUPERIORITY_OR_OTHER|||||||0.343||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3430
74002103|NCT00706433|147552783|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002104|NCT00706433|147552784|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002105|NCT00706433|147552785|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002106|NCT00706433|147552786|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002107|NCT00706433|147552787|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002108|NCT00706433|147552788|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002109|NCT00706433|147552789|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002110|NCT00706433|147552790|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002111|NCT00706433|147552791|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002112|NCT00706433|147552792|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002113|NCT00706433|147552793|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002114|NCT00706433|147552794|SUPERIORITY_OR_OTHER|||||||0.0165||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0165
74002115|NCT00706433|147552794|SUPERIORITY_OR_OTHER|||||||0.2252||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2252
74008794|NCT03044886|147567676|SUPERIORITY|||||||0.521|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.521
74008795|NCT03044886|147567677|SUPERIORITY|||||||0.742|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.742
74008796|NCT03044886|147567678|SUPERIORITY||||||<|0.05|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||<0.05
74008797|NCT03044886|147567678|SUPERIORITY|||||||0.073|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.073
74008798|NCT03044886|147567679|SUPERIORITY|||||||0.348|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.348
74008799|NCT03044886|147567680|SUPERIORITY|||||||0.685|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.685
74008800|NCT03044886|147567681|SUPERIORITY|||||||0.075|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.075
74008801|NCT03044886|147567681|SUPERIORITY|||||||0.083|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.083
74008802|NCT01660451|147567689|SUPERIORITY_OR_OTHER_LEGACY||Response rate|45.45||||0.0001|TWO_SIDED|90.0|30.49|61.06||0.0001|Exact binomial test|||Response rate was statistically compared by exact binomial test if higher than 5%.||61.06|30.49|0.0001
74008803|NCT01660451|147567689|SUPERIORITY_OR_OTHER_LEGACY||Response rate|27.08||||0.0001|TWO_SIDED|90.0|16.83|39.57||0.0001|Exact binominal test|P-value was based on the original patients in the aggressive arm (for the first 34 patients), not including the additional recruited patients.||Response rate was statistically compared by exact binomial test if higher than 5%.||39.57|16.83|0.0001
74008804|NCT01660451|147567690|SUPERIORITY_OR_OTHER_LEGACY||Response rate|59.15|||<|0.0001|TWO_SIDED|95.0|50.6|67.32||0.001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.||67.32|50.60|<0.0001
74002116|NCT00706433|147552794|SUPERIORITY_OR_OTHER|||||||0.0179||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0179
74002117|NCT00706433|147552794|SUPERIORITY_OR_OTHER|||||||0.0233||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0233
74002118|NCT00706433|147552794|SUPERIORITY_OR_OTHER|||||||0.1573||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1573
74002119|NCT00706433|147552794|SUPERIORITY_OR_OTHER|||||||0.2039||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2039
74002120|NCT00706433|147552794|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002121|NCT00706433|147552795|SUPERIORITY_OR_OTHER|||||||0.1594||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1594
74002122|NCT00706433|147552796|SUPERIORITY_OR_OTHER|||||||0.5838||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5838
74037214|NCT01122030|147627705|SUPERIORITY_OR_OTHER|||||||0.7978||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7978
74037215|NCT01122030|147627705|SUPERIORITY_OR_OTHER|||||||0.7143||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7143
74037216|NCT01122030|147627705|SUPERIORITY_OR_OTHER|||||||0.7531||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7531
74002123|NCT00706433|147552797|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0064
74002124|NCT00706433|147552797|SUPERIORITY_OR_OTHER|||||||0.0939||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0939
74002125|NCT00706433|147552797|SUPERIORITY_OR_OTHER|||||||0.3173||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3173
74002126|NCT00706433|147552797|SUPERIORITY_OR_OTHER|||||||0.2207||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2207
74002127|NCT00706433|147552797|SUPERIORITY_OR_OTHER|||||||0.0183||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0183
74002128|NCT00706433|147552797|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0254
74002129|NCT00706433|147552797|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002130|NCT00706433|147552798|SUPERIORITY_OR_OTHER|||||||0.4753||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4753
74002131|NCT00706433|147552799|SUPERIORITY_OR_OTHER|||||||0.1728||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1728
74002132|NCT00706433|147552800|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0002
74037217|NCT01122030|147627705|SUPERIORITY_OR_OTHER|||||||0.0283||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.0283
74037218|NCT01122030|147627705|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
74037219|NCT01122030|147627705|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
74090871|NCT03456960|147735906|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0148|||||TWO_SIDED|90.0|-0.0734|0.103||||||||0.1030|-0.0734|
74090872|NCT03456960|147735906|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.002|||||TWO_SIDED|90.0|-0.0463|0.0424||||||||0.0424|-0.0463|
74090873|NCT03456960|147735907|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2138|||||TWO_SIDED|90.0|0.1609|0.2667||||||||0.2667|0.1609|
74002133|NCT00706433|147552800|SUPERIORITY_OR_OTHER|||||||0.5313||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5313
74002134|NCT00706433|147552800|SUPERIORITY_OR_OTHER|||||||0.0045||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0045
74002135|NCT00706433|147552800|SUPERIORITY_OR_OTHER|||||||0.0045||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0045
74002136|NCT00706433|147552800|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0012
74002137|NCT00706433|147552800|SUPERIORITY_OR_OTHER|||||||0.0015||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0015
74002138|NCT00706433|147552800|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002139|NCT00706433|147552801|SUPERIORITY_OR_OTHER|||||||0.0892||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0892
74002140|NCT00706433|147552802|SUPERIORITY_OR_OTHER|||||||0.4575||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4575
74002141|NCT00706433|147552803|SUPERIORITY_OR_OTHER|||||||0.8848||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8848
74002142|NCT00706433|147552804|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0008
74002143|NCT00706433|147552804|SUPERIORITY_OR_OTHER|||||||0.4091||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4091
74002144|NCT00706433|147552804|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0176
74002145|NCT00706433|147552804|SUPERIORITY_OR_OTHER|||||||0.0245||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0245
74002146|NCT00706433|147552804|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0020
74002147|NCT00706433|147552804|SUPERIORITY_OR_OTHER|||||||0.0022||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0022
74002148|NCT00706433|147552804|SUPERIORITY_OR_OTHER|||||||0.9372||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9372
74002149|NCT00706433|147552805|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2390
74002150|NCT00706433|147552806|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002151|NCT00706433|147552807|SUPERIORITY_OR_OTHER|||||||0.0463||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0463
74002152|NCT00706433|147552807|SUPERIORITY_OR_OTHER|||||||0.1261||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1261
74090874|NCT03456960|147735908|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2161|||||TWO_SIDED|90.0|0.1652|0.2671||||||||0.2671|0.1652|
74037220|NCT01122030|147627706|SUPERIORITY_OR_OTHER|||||||0.6269||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.6269
74037221|NCT01122030|147627706|SUPERIORITY_OR_OTHER|||||||0.7456||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7456
74037222|NCT01122030|147627706|SUPERIORITY_OR_OTHER|||||||0.1968||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.1968
74037223|NCT01122030|147627706|SUPERIORITY_OR_OTHER|||||||0.8708||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.8708
74037224|NCT01122030|147627706|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||<0.0001
74037225|NCT01122030|147627706|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.0002
74037226|NCT01122030|147627707|SUPERIORITY_OR_OTHER|||||||0.6131||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.6131
74037227|NCT01122030|147627707|SUPERIORITY_OR_OTHER|||||||0.9293||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.9293
74090875|NCT03456960|147735909|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.219|||||TWO_SIDED|90.0|0.1675|0.2706||||||||0.2706|0.1675|
74090876|NCT03456960|147735910|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.3653|||||TWO_SIDED|90.0|0.218|0.5126||||||||0.5126|0.2180|
74090877|NCT03456960|147735913|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2089|||||TWO_SIDED|90.0|-0.0061|0.4239||||||||0.4239|-0.0061|
74090878|NCT03456960|147735913|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.014|||||TWO_SIDED|90.0|-0.0639|0.0918||||||||0.0918|-0.0639|
74037228|NCT01122030|147627707|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7990
74037229|NCT01122030|147627707|SUPERIORITY_OR_OTHER|||||||0.7674||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7674
74037230|NCT01122030|147627707|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||<0.0001
74037231|NCT01122030|147627707|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.0018
74037232|NCT01122030|147627708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.7434|TWO_SIDED|95.0|0.42|3.92|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||3.92|0.42|0.7434
74037233|NCT01122030|147627708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54||||0.4449|TWO_SIDED|95.0|0.54|4.42|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||4.42|0.54|0.4449
74037234|NCT01122030|147627708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.8129|TWO_SIDED|95.0|0.27|2.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||2.72|0.27|0.8129
74037235|NCT01122030|147627708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.52||||0.0005|TWO_SIDED|95.0|2.29|24.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||24.72|2.29|0.0005
74037236|NCT01122030|147627708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|9.93|||<|0.0001|TWO_SIDED|95.0|3.09|31.89|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||31.89|3.09|<0.0001
74037237|NCT01122030|147627708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|202272814.0|||<|0.0001||95.0|||||Log Rank|P-values were obtained from the log-rank test stratified by Gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.|||||<0.0001
74037238|NCT01122030|147627709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.4923|TWO_SIDED|95.0|0.53|4.28|||Log Rank|P-values are from the log rank test stratified by gender.||||4.28|0.53|0.4923
74037239|NCT01122030|147627709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.5479|TWO_SIDED|95.0|0.52|4.06|||Log Rank|P-values are from the log rank test stratified by gender.||||4.06|0.52|0.5479
74037240|NCT01122030|147627709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.506|TWO_SIDED|95.0|0.56|3.67|||Log Rank|P-values are from the log rank test stratified by gender.||||3.67|0.56|0.5060
74037241|NCT01122030|147627709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.36||||0.0005|TWO_SIDED|95.0|2.27|23.9|||Log Rank|P-values are from the log rank test stratified by gender.||||23.90|2.27|0.0005
74037242|NCT01122030|147627709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|9.54|||<|0.0001|TWO_SIDED|95.0|3.0|30.35|||Log Rank|P-values are from the log rank test stratified by gender.||||30.35|3.00|<0.0001
74002153|NCT00706433|147552807|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002154|NCT00706433|147552807|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002155|NCT00706433|147552807|SUPERIORITY_OR_OTHER|||||||0.0947||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0947
74002156|NCT00706433|147552807|SUPERIORITY_OR_OTHER|||||||0.0886||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0886
74002157|NCT00706433|147552807|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74037243|NCT01122030|147627709|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|192233779.0|||<|0.0001||95.0|||||Log Rank|P-values are from the log rank test stratified by gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.|||||<0.0001
74002158|NCT00706433|147552808|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
74002159|NCT00706433|147552808|SUPERIORITY_OR_OTHER|||||||0.0255||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0255
74002160|NCT00706433|147552808|SUPERIORITY_OR_OTHER|||||||0.0576||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0576
74002161|NCT00706433|147552808|SUPERIORITY_OR_OTHER|||||||0.0686||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0686
74002162|NCT00706433|147552808|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0004
74037244|NCT01122030|147627710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.45||||0.1523|TWO_SIDED|95.0|0.62|19.35|||Log Rank|P-values are from the log rank test stratified by gender.||||19.35|0.62|0.1523
74002163|NCT00706433|147552808|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0005
74002164|NCT00706433|147552808|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002165|NCT00706433|147552809|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0006
74002166|NCT00706433|147552809|SUPERIORITY_OR_OTHER|||||||0.0245||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0245
74002167|NCT00706433|147552809|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002168|NCT00706433|147552809|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74037245|NCT01122030|147627710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.55||||0.0856|TWO_SIDED|95.0|0.76|27.07|||Log Rank|P-values are from the log rank test stratified by gender.||||27.07|0.76|0.0856
74037246|NCT01122030|147627710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.81||||0.5284|TWO_SIDED|95.0|0.3|10.98|||Log Rank|P-values are from the log rank test stratified by gender.||||10.98|0.30|0.5284
74037247|NCT01122030|147627710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.8594|TWO_SIDED|95.0|0.09|8.66|||Log Rank|P-values are from the log rank test stratified by gender.||||8.66|0.09|0.8594
74037248|NCT01122030|147627710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|59.34|||<|0.0001|TWO_SIDED|95.0|6.55|537.38|||Log Rank|P-values are from the log rank test stratified by gender.||||537.38|6.55|<0.0001
73877862|NCT03040141|147295362|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.446|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.446
74037249|NCT01122030|147627710|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|10.99||||0.0007|TWO_SIDED|95.0|2.3|52.57|||Log Rank|P-values are from the log rank test stratified by gender.||||52.57|2.30|0.0007
74037250|NCT01122030|147627712|SUPERIORITY_OR_OTHER|||||||0.5054||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.5054
74037251|NCT01122030|147627712|SUPERIORITY_OR_OTHER|||||||0.9688||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.9688
74037252|NCT01122030|147627712|SUPERIORITY_OR_OTHER|||||||0.6963||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.6963
74090879|NCT03456960|147735914|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2099|||||TWO_SIDED|90.0|-0.0048|0.4246||||||||0.4246|-0.0048|
74090880|NCT03456960|147735914|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0137|||||TWO_SIDED|90.0|-0.0712|0.0986||||||||0.0986|-0.0712|
74090881|NCT03456960|147735915|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2096|||||TWO_SIDED|90.0|-0.0054|0.4246||||||||0.4246|-0.0054|
74090882|NCT03456960|147735915|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0201|||||TWO_SIDED|90.0|-0.069|0.1092||||||||0.1092|-0.0690|
74090883|NCT03456960|147735916|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.4058|||||TWO_SIDED|90.0|0.0803|0.7312||||||||0.7312|0.0803|
74090884|NCT03456960|147735916|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.1969|||||TWO_SIDED|90.0|0.1065|0.2873||||||||0.2873|0.1065|
74090885|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|1.12|STANDARD_ERROR_OF_MEAN|2.0801|||TWO_SIDED|95.0|-3.0|5.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.2|-3.0|
74037253|NCT01122030|147627712|SUPERIORITY_OR_OTHER|||||||0.9599||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.9599
74037254|NCT01122030|147627712|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0001
74037255|NCT01122030|147627712|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0006
74037256|NCT01122030|147627713|SUPERIORITY_OR_OTHER|||||||0.3441||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.3441
74090886|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|2.66|STANDARD_ERROR_OF_MEAN|2.0796|||TWO_SIDED|95.0|-1.4|6.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.8|-1.4|
74090887|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.0792|||TWO_SIDED|95.0|-1.1|7.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.1|-1.1|
74037257|NCT01122030|147627713|SUPERIORITY_OR_OTHER|||||||0.7159||95.0||||P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|ANCOVA|||||||0.7159
74037258|NCT01122030|147627713|SUPERIORITY_OR_OTHER|||||||0.7342||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.7342
74090888|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|2.53|STANDARD_ERROR_OF_MEAN|2.079|||TWO_SIDED|95.0|-1.6|6.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.6|-1.6|
74090889|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|1.72|STANDARD_ERROR_OF_MEAN|2.0789|||TWO_SIDED|95.0|-2.4|5.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.8|-2.4|
74090890|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.15|STANDARD_ERROR_OF_MEAN|2.079|||TWO_SIDED|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-4.2|
74090891|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.15|STANDARD_ERROR_OF_MEAN|2.0792|||TWO_SIDED|95.0|-7.2|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-7.2|
74090892|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.31|STANDARD_ERROR_OF_MEAN|2.0796|||TWO_SIDED|95.0|-5.4|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-5.4|
74090893|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.15|STANDARD_ERROR_OF_MEAN|2.0801|||TWO_SIDED|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-4.2|
74002169|NCT00706433|147552809|SUPERIORITY_OR_OTHER|||||||0.0097||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0097
74002170|NCT00706433|147552809|SUPERIORITY_OR_OTHER|||||||0.0146||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0146
74002171|NCT00706433|147552809|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002172|NCT00706433|147552810|SUPERIORITY_OR_OTHER|||||||0.4235||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4235
74002173|NCT00706433|147552811|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002174|NCT00706433|147552812|SUPERIORITY_OR_OTHER|||||||0.0865||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0865
74002175|NCT00706433|147552813|SUPERIORITY_OR_OTHER|||||||0.623||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6230
74002176|NCT00706433|147552814|SUPERIORITY_OR_OTHER|||||||0.0963||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0963
74002177|NCT00706433|147552815|SUPERIORITY_OR_OTHER|||||||0.4814||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4814
74002178|NCT00706433|147552816|SUPERIORITY_OR_OTHER|||||||0.7153||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7153
74002179|NCT00706433|147552817|SUPERIORITY_OR_OTHER|||||||0.3832||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3832
74002180|NCT00706433|147552818|SUPERIORITY_OR_OTHER|||||||0.2908||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2908
74002181|NCT00706433|147552819|SUPERIORITY_OR_OTHER|||||||0.8096||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8096
74002182|NCT00706433|147552820|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3080
74002183|NCT00706433|147552821|SUPERIORITY_OR_OTHER|||||||0.3208||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3208
74002184|NCT00706433|147552822|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002185|NCT00706433|147552823|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
74002186|NCT01236365|147552824|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change in LDL-C between Atorvastatin and Placebo|Mixed Models Analysis|||||||<0.0001
74002187|NCT01236365|147552825|SUPERIORITY_OR_OTHER|||||||0.913|TWO_SIDED|||||Change in hsCRP (6months minus 0months) between Atorvastatin and Placebo|Wilcoxon (Mann-Whitney)|||||||0.913
74002188|NCT01236365|147552828|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
74002189|NCT00717067|147552829|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|129.17||||||90.0|92.16|181.04|||ANOVA|||Ratio (%) test (mild) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||181.04|92.16|
74002190|NCT00717067|147552829|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|88.31||||||90.0|61.97|125.83|||ANOVA|||Ratio (%) test (moderate) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||125.83|61.97|
74002191|NCT00717067|147552829|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|322.23||||||90.0|171.97|603.78|||ANOVA|||Ratio (%) test (severe) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||603.78|171.97|
74002192|NCT00717067|147552830|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|151.99||||||90.0|109.53|210.92|||ANOVA|||Ratio (%) test (mild) / reference (normal).||210.92|109.53|
74002193|NCT00717067|147552830|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|115.95||||||90.0|82.23|163.5|||ANOVA|||Ratio (%) test (moderate) / reference (normal).||163.50|82.23|
74002194|NCT00717067|147552831|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|121.01||||||90.0|83.15|176.13|||ANOVA|||Ratio (%) test (mild) / reference (normal).||176.13|83.15|
74002195|NCT00717067|147552831|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|70.9||||||90.0|47.83|105.1|||ANOVA|||Ratio (%) test (moderate) / reference (normal).||105.10|47.83|
74002196|NCT00717067|147552831|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|238.73||||||90.0|106.83|533.48|||ANOVA|||Ratio (%) test (severe) / reference (normal).||533.48|106.83|
74002197|NCT00717067|147552833|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|323.91||||||90.0|174.32|601.88|||ANOVA|||Ratio (%) test (severe) / reference (normal).||601.88|174.32|
74002198|NCT03406260|147552873|NON_INFERIORITY|A p-value \< 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.63|||<|0.0001|TWO_SIDED|95.0|-1000.0|1.81|||Linear Mixed Effects Model|||||1.81|-1000|<0.0001
74002199|NCT03406260|147552873|NON_INFERIORITY|A p-value \< 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1000.0|2.06|||Linear Mixed Effects Model|||||2.06|-1000|<0.0001
74002200|NCT00871780|147552876|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon signed rank test|||Baseline, Week 24||||0.0003
74002201|NCT00871780|147552876|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0002
74002202|NCT00871780|147552877|SUPERIORITY_OR_OTHER|||||||0.0148|||||||Wilcoxon signed rank test|||Baseline, Week 24||||0.0148
74002203|NCT00871780|147552877|SUPERIORITY_OR_OTHER|||||||0.0119|||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0119
74002204|NCT00871780|147552878|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 24||||<0.0001
74002205|NCT00871780|147552878|SUPERIORITY_OR_OTHER|||||||0.0157|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0157
74002206|NCT00871780|147552879|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 24||||<0.0001
74002207|NCT00871780|147552879|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 48||||<0.0001
74002208|NCT00871780|147552880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
74002209|NCT00871780|147552880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
74002210|NCT00871780|147552880|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
74002211|NCT00871780|147552881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
74002212|NCT00871780|147552881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
74002213|NCT00871780|147552881|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
74002214|NCT00871780|147552882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
74002215|NCT00871780|147552882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
74002216|NCT00871780|147552882|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
74002217|NCT00871780|147552883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
74002218|NCT00871780|147552883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
74002219|NCT00871780|147552883|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
74002220|NCT00871780|147552884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
74002221|NCT00871780|147552884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
74002222|NCT00871780|147552884|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
74002223|NCT00871780|147552885|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
74002224|NCT00871780|147552885|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
74002225|NCT00871780|147552885|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
74002226|NCT00871780|147552886|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
74090894|NCT02037165|147735936|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.68|STANDARD_ERROR_OF_MEAN|2.0282|||TWO_SIDED|95.0|-6.7|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-6.7|
74002227|NCT00871780|147552886|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||0.0016
74002228|NCT00871780|147552886|SUPERIORITY_OR_OTHER|||||||0.0866|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||0.0866
74002229|NCT00871780|147552887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
74002230|NCT00871780|147552887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
74002231|NCT00871780|147552887|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
74002232|NCT02700945|147552889|SUPERIORITY|The 12-month Kaplan-Meier estimate will be reported for each arm. The hazard ratio estimate for the treatment effect with its 95% confidence interval will be reported.|Hazard Ratio (HR)|7.4|||<|0.001|TWO_SIDED|95.0|2.6|21.3||A priori threshold is .05|Log Rank||A hazard ratio of \> 1 indicates that continuous monitoring arm is superior to control arm in detecting AF.|H0: h(t) = hT(t) for t ≤ 12 months HA: hC(t) ≠ hT(t) for t ≤ 12 months where hT(t) and hC(t) are the hazard functions of first detected and adjudicated AF at time t for subjects with and without the Reveal LINQ diagnostics for AF, respectively. Hazard functions and survival functions are transformations of each other.||21.3|2.6|<0.001
74002233|NCT00069108|147552894|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|Hazard Ratio (HR)|1.03||||0.00584|TWO_SIDED|95.0|0.87|1.24|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|||1.24|0.87|0.00584
74002234|NCT00069108|147552895|NON_INFERIORITY_OR_EQUIVALENCE|While the study was not designed to demonstrate non-inferiority in PFS based on IRC assessments the pre-specified margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|0.93||||0.00223|TWO_SIDED|95.0|0.74|1.17|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|||1.17|0.74|0.00223
74002235|NCT00069108|147552896|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.91|1.37||||||||1.37|0.91|
74002236|NCT00069108|147552897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.95|1.47||||||||1.47|0.95|
74002237|NCT00069108|147552898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4028|TWO_SIDED|95.0|0.79|1.77||p-value is for difference between response rates.|Chi-squared|||||1.77|0.79|0.4028
74002238|NCT00069108|147552899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.2911|TWO_SIDED|95.0|0.81|2.01||p-value is for difference between response rates.|Chi-squared|||||2.01|0.81|0.2911
74002239|NCT00069108|147552900|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% CI of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.87|1.23||||||||1.23|0.87|
74002240|NCT00069108|147552902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.79|1.68||||||||1.68|0.79|
74002241|NCT00069108|147552903|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.81|1.12||||||||1.12|0.81|
74008805|NCT01660451|147567691|SUPERIORITY_OR_OTHER_LEGACY||Response rate|46.88||||0.0001|TWO_SIDED|90.0|31.54|62.66||0.0001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 5%.||62.66|31.54|0.0001
74008806|NCT01660451|147567691|SUPERIORITY_OR_OTHER_LEGACY||Response rate|31.25||||0.0001|TWO_SIDED|90.0|20.35|43.97||0.0001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 5%.||43.97|20.35|0.0001
74008807|NCT01660451|147567692|SUPERIORITY_OR_OTHER_LEGACY||Response rate|51.41||||0.0039|TWO_SIDED|95.0|42.88|59.87||0.01|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.||59.87|42.88|0.0039
74008808|NCT01660451|147567703|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimate|1.0|||||TWO_SIDED|95.0|0.5|2.5||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.||2.5|0.5|
74008809|NCT01660451|147567704|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimate|0.5|||||TWO_SIDED|95.0|-0.7|3.2||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.||3.2|-0.7|
74008810|NCT02456662|147567707|SUPERIORITY|Based on previous work as well as anecdotal data from our clinic population, we expect vomiting to occur in approximately 30% of our patients who take their doxycycline the night before their procedure. To have 80% power to detect a 50% decrease in nausea and vomiting, we will need 122 patients in each arm of the study.||||||0|||||||Chi-squared|||||||0.00
74090895|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|1.58|STANDARD_ERROR_OF_MEAN|2.0279|||TWO_SIDED|95.0|-2.4|5.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.6|-2.4|
74090896|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|2.63|STANDARD_ERROR_OF_MEAN|2.0278|||TWO_SIDED|95.0|-1.4|6.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.6|-1.4|
74090897|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.17|STANDARD_ERROR_OF_MEAN|2.0277|||TWO_SIDED|95.0|-4.2|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-4.2|
74090898|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|1.2|STANDARD_ERROR_OF_MEAN|2.0276|||TWO_SIDED|95.0|-2.8|5.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.2|-2.8|
74090899|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|2.0277|||TWO_SIDED|95.0|-4.6|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-4.6|
74090900|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.88|STANDARD_ERROR_OF_MEAN|2.0278|||TWO_SIDED|95.0|-6.9|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-6.9|
74002242|NCT00116337|147552905|OTHER|Statistical analyses was performed using a repeated measures analysis of variance and Paired t test. A p value of \< 0.05 was taken as indicating statistical significance.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control; comparisons was made at various points in the study. Clinical parameters was assessed before the study and also at several end points following the Reconditioning Phase.||||<0.05
74002243|NCT00116337|147552907|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation were compared with data obtained after implantation of the cough system using a nonparametric analog (Freidman Test) to the standard repeated measures analysis of variance. Statistical significance was assumed at P\<0.05. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± SEs.||||<0.05
74002244|NCT02483585|147552943|SUPERIORITY|A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the primary and efficacy secondary endpoints.|LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.61|-0.47|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.||-0.47|-1.61|< 0.001
74002245|NCT02483585|147552944|SUPERIORITY||Odds Ratio (OR)|1.59||||0.01|TWO_SIDED|95.0|1.12|2.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||2.27|1.12|0.010
74002246|NCT02483585|147552945|SUPERIORITY||LS Mean Difference|-0.59||||0.002|TWO_SIDED|95.0|-0.96|-0.21|||Generalized Linear Mixed Model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.||-0.21|-0.96|0.002
74002247|NCT02483585|147552946|SUPERIORITY||Odds Ratio (OR)|1.22||||0.26|TWO_SIDED|95.0|0.87|1.71|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||1.71|0.87|0.26
74002248|NCT02483585|147552947|SUPERIORITY||Odds Ratio (OR)|1.33||||0.13|TWO_SIDED|95.0|0.92|1.9|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||1.90|0.92|0.13
74002249|NCT00825916|147552951|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.078
74002250|NCT00825916|147552951|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.086
74002251|NCT00825916|147552951|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.92
74002252|NCT00825916|147552951|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.49
74002253|NCT00825916|147552952|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.74
74002254|NCT00825916|147552952|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.59
74002255|NCT00825916|147552952|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.69
74002256|NCT00825916|147552952|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||1.00
74002257|NCT00825916|147552953|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.34
74002258|NCT00825916|147552953|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.98
74002259|NCT00825916|147552953|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.15
74002260|NCT00825916|147552953|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.83
74002261|NCT00825916|147552953|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.95
74002262|NCT00825916|147552953|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.59
74002263|NCT00825916|147552953|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.76
74002264|NCT00825916|147552953|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.63
74002265|NCT00825916|147552953|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.92
74002266|NCT00825916|147552953|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.69
74002267|NCT00825916|147552954|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.||||||0.95
74002268|NCT00825916|147552954|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.76
74002269|NCT00825916|147552954|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.60
74002270|NCT00825916|147552954|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.44
74002271|NCT00825916|147552954|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.85
74002272|NCT00825916|147552954|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.83
74002273|NCT00912301|147552958|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Dunnett's test|pairwise comparison low dose NaCDC against placebo||||||0.031
74002274|NCT00912301|147552958|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Dunnett's test|pairwise comparison high dose NaCDC against placebo||||||0.010
74002275|NCT02943226|147553004|SUPERIORITY|||||||0.4487|||||||two sample t-test|||||||0.4487
74002276|NCT02943226|147553005|SUPERIORITY|||||||0.0112|||||||Wilcoxon (Mann-Whitney)|||||||0.0112
74002277|NCT02943226|147553006|SUPERIORITY|||||||0.0784|||||||two sample t-test|||||||0.0784
74002278|NCT02996565|147553008|SUPERIORITY||Mean Difference (Net)|-0.76||||0.45|TWO_SIDED|95.0|-2.84|1.33||The threshold for statistical significance was p = 0.05.|planned contrast|The planned contrast compares model-predicted change in SBP from index to 365 days in Telehealth Care vs. Best Practice Clinic-Based Care.|adjusted for baseline SBP, baseline DBP, baseline age, sex, Asian race|||1.33|-2.84|0.45
74002279|NCT02996565|147553009|SUPERIORITY|Random coefficients model predicted all EHR-documented DBPs from treatment group, days elapsed from index to each DBP (time) and treatment group by time with random clinic and patient intercepts.|Mean Difference (Net)|0.28||||0.64|TWO_SIDED|95.0|-0.95|1.51||The threshold for statistical significance was p\<0.05|planned contrast|The planned contrast compares the model-predicted change in DBP from index to 365 days in Telehealth care vs. index to 365 days in clinic based care.|adjusted for baseline SBP, baseline DBP, baseline age, sex, Asian race|||1.51|-0.95|0.64
74002280|NCT02996565|147553010|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.53|||<|0.001|TWO_SIDED|95.0|1.27|1.85||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood pf reporting high satisfaction at 6 months relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.85|1.27|<0.001
74008811|NCT00074581|147567719|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.02|0.22|||Regression, Cox||The hazard ratio estimate presented (0.07) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 93% lower risk of infection among all linked partner infections, during the entire study.|||0.22|0.02|<0.0001
74090901|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|0.43|STANDARD_ERROR_OF_MEAN|2.0279|||TWO_SIDED|95.0|-3.6|4.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-3.6|
74002281|NCT02996565|147553011|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.25||||0.03|TWO_SIDED|95.0|1.02|1.52||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood pf reporting high satisfaction at 6 months relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.52|1.02|0.03
74002282|NCT02996565|147553012|SUPERIORITY|Random coefficients model predicted the likelihood that smoking was current 12 months by treatment group with random clinic intercept.|Risk Ratio (RR)|1.01||||0.73|TWO_SIDED|95.0|0.95|1.07||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The risk ratio compares the likelihood of current smoking at 12 months in Telehealth care vs. clinic based care|unadjusted|||1.07|0.95|0.73
74002283|NCT02996565|147553013|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.17||||0.08|TWO_SIDED|95.0|0.98|1.4||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.4|.98|0.08
74002284|NCT02996565|147553014|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.11||||0.18|TWO_SIDED|95.0|0.95|1.29||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.29|0.95|0.18
74002285|NCT02996565|147553015|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.98||||0.77|TWO_SIDED|95.0|0.87|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|0.87|0.77
74002286|NCT02996565|147553016|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.93||||0.32|TWO_SIDED|95.0|0.8|1.08||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.08|0.80|0.32
74002287|NCT02996565|147553017|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.95||||0.62|TWO_SIDED|95.0|0.76|1.19||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.19|0.76|0.62
74002288|NCT02996565|147553018|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.91|1.08||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.08|0.91|0.87
74008812|NCT00074581|147567720|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.19|0.53|||Regression, Cox||The hazard ratio estimate presented (0.31) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 69% lower risk of infection among all partner infections, during the entire study.|||0.53|0.19|<0.0001
74008813|NCT01034540|147567747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.959||||||Values were not normally distributed, thus analyses were performed on ranked values and medians (IQL) are presented.|ANOVA|All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).||An evaluable sample of 19 subjects provided 80% power (5% alpha-level, 2-tailed) to detect a 2.1 unit difference between control and active in MISI, assuming a 3.0 unit standard deviation (SD). Repeated measures ANOVA was used to assess responses to treatment. Initial repeated measures models contained terms of treatment period, and sequence as fixed effects, with subject modeled as random effect; models were reduced until only significant terms or treatment remained.||||0.959
74008814|NCT01034540|147567748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).||||||0.037
74008815|NCT01034540|147567748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||||||All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).|ANOVA|||||||0.073
74002289|NCT02996565|147553019|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.95||||0.51|TWO_SIDED|95.0|0.82|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|0.82|0.51
74002290|NCT02996565|147553020|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.09||||0.41|TWO_SIDED|95.0|0.87|1.37||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.37|0.87|0.41
74002291|NCT02996565|147553021|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.9||||0.18|TWO_SIDED|95.0|0.77|1.06||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity was helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.06|0.77|0.18
74002292|NCT02996565|147553022|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.92||||0.31|TWO_SIDED|95.0|0.78|1.09||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.09|0.78|0.31
74002293|NCT02996565|147553023|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.56|TWO_SIDED|95.0|0.89|1.22||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.22|0.89|0.56
74002294|NCT02996565|147553024|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.84||||0.08|TWO_SIDED|95.0|0.68|1.03||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.03|0.68|0.08
74002295|NCT02996565|147553025|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.9||||0.32|TWO_SIDED|95.0|0.73|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|.73|0.32
74002296|NCT02996565|147553026|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.14||||0.09|TWO_SIDED|95.0|0.98|1.33||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.33|0.98|0.09
74002297|NCT02996565|147553027|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.98||||0.77|TWO_SIDED|95.0|0.83|1.16||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.16|0.83|0.77
74037259|NCT01122030|147627713|SUPERIORITY_OR_OTHER|||||||0.8714||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.8714
74037260|NCT01122030|147627713|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||<0.0001
74037261|NCT01122030|147627713|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0006
74037262|NCT00077610|147627738|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.004|STANDARD_ERROR_OF_MEAN|0.0973|<|0.0001|TWO_SIDED|97.5|-0.215|0.223|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on analysis of co-variance (ANCOVA) analysis with a non-inferiority limit of -0.75 g/dL.||0.223|-0.215|<0.0001
74039823|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.14||0.079|TWO_SIDED|95.0|-0.5|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.50|0.0790
74002298|NCT02996565|147553028|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.21||||0.09|TWO_SIDED|95.0|0.97|1.5||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.5|.97|0.09
74037263|NCT00077610|147627738|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.3 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.051|STANDARD_ERROR_OF_MEAN|0.0997|<|0.0001|TWO_SIDED|97.5|-0.173|0.275|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL.||0.275|-0.173|<0.0001
74037264|NCT00304915|147627749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.003|TWO_SIDED|95.0|1.37|4.56|||Regression, Logistic|||||4.56|1.37|0.003
74037265|NCT04124042|147627750|SUPERIORITY||Odds Ratio (OR)|0.655|||||TWO_SIDED|95.0|0.347|1.237||||||||1.237|0.347|
74037266|NCT04124042|147627750|SUPERIORITY||Odds Ratio (OR)|0.714|||||TWO_SIDED|95.0|0.381|1.336||||||||1.336|0.381|
74037267|NCT04124042|147627751|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.539||0.413|TWO_SIDED|95.0|-0.62|1.5|||Mixed Models Analysis|||||1.50|-0.62|0.413
74037268|NCT04124042|147627751|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.535||0.629|TWO_SIDED|95.0|-0.79|1.31|||Mixed Models Analysis|||||1.31|-0.79|0.629
74002299|NCT02996565|147553029|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.64||||0.02|TWO_SIDED|95.0|0.45|0.92||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||0.92|0.45|0.02
74002300|NCT02996565|147553030|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.7||||0.006|TWO_SIDED|95.0|0.55|0.89||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||.89|.55|0.006
74002301|NCT02996565|147553031|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.78||||0.06|TWO_SIDED|95.0|0.6|1.01||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.01|0.60|0.06
74002302|NCT02996565|147553032|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.02||||0.65|TWO_SIDED|95.0|0.94|1.1||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.10|0.94|0.65
74002303|NCT02996565|147553033|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.02||||0.83|TWO_SIDED|95.0|0.83|1.25||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.25|0.83|0.83
74002304|NCT02996565|147553034|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.41|TWO_SIDED|95.0|0.95|1.13||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.13|0.95|0.41
74002305|NCT02996565|147553035|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.4|TWO_SIDED|95.0|0.94|1.16||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.16|0.94|0.40
74002306|NCT02996565|147553036|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.01||||0.74|TWO_SIDED|95.0|0.95|1.07||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.07|0.95|0.74
74037269|NCT04124042|147627756|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.1374|TWO_SIDED|95.0|-0.16|1.16|||Mixed Models Analysis|||||1.16|-0.16|0.1374
74037270|NCT04124042|147627756|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.2807|TWO_SIDED|95.0|-0.29|1.0|||Mixed Models Analysis|||||1.00|-0.29|0.2807
74037271|NCT04124042|147627757|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.142||0.346|TWO_SIDED|95.0|-0.14|0.41|||Mixed Models Analysis|||||0.41|-0.14|0.346
73877863|NCT03040141|147295362|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.53|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.530
74002307|NCT02996565|147553037|SUPERIORITY|Random coefficients model predicted the likelihood that a new statin was current at 12 months by treatment group with random clinic intercept.|Risk Ratio (RR)|1.05||||0.71|TWO_SIDED|95.0|0.81|1.37||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The risk ratio compares the likelihood of a new statin medication that is current at 12 months in Telehealth care vs. clinic based care|adjusted for baseline SBP , baseline DBP, baseline age, sex, Asian race|||1.37|0.81|0.71
74002308|NCT01602562|147553038|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|16.11|||||The estimated value reflects the percentage of participants with an HSV infection.|||16.11|0.00|
74002309|NCT01602562|147553038|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|17.65|||||The estimated value reflects the percentage of participants with an HSV infection.|||17.65|0.00|
74002310|NCT03881553|147553053|OTHER|Non-parametric Friedmans||||||0.081||||||χ2 =5.03|Friedman's|||||||0.081
74002311|NCT03881553|147553053|OTHER|Post hoc: Wilcoxon||||||0.05||||||ON1 compared to OFF1|Wilcoxon (Mann-Whitney)|||||||0.05
74037272|NCT04124042|147627757|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.968|TWO_SIDED|95.0|-0.27|0.28|||Mixed Models Analysis|||||0.28|-0.27|0.968
74037273|NCT04124042|147627759|SUPERIORITY||Mean Difference (Final Values)|-2.83||||0.0081|TWO_SIDED|95.0|-4.91|-0.75|||Mixed Models Analysis|||Outcome measure #10 is an analysis of 2 tx groups (two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml), whereas outcome measure #12 is all 6 tx groups. A MMRM model was used. LS Means in an MMRM model are influenced by the overall mean structure and covariance estimation. When fewer treatment groups are included, the model adjusts based on a different subset of data, leading to potential shifts in estimated LS Means due to changes in the reference population/covariance structure.||-0.75|-4.91|0.0081
74037274|NCT04124042|147627760|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.0101|TWO_SIDED|95.0|-16.85|-2.34|||Mixed Models Analysis|||Outcome measure #11 is an analysis of 2 tx groups (two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml), whereas outcome measure #13 is all 6 tx groups. A MMRM model was used. LS Means in an MMRM model are influenced by the overall mean structure and covariance estimation. When fewer treatment groups are included, the model adjusts based on a different subset of data, leading to potential shifts in estimated LS Means due to changes in the reference population/covariance structure.||-2.34|-16.85|0.0101
74037275|NCT02662985|147627764|SUPERIORITY||Median Difference (Net)|-3.18|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.52|-0.85|||Mixed Models Analysis|mixed model repeated measures (MMRM)||GLOESS scores||-0.85|-5.52|0.0040
74037276|NCT02662985|147627765|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.0001|TWO_SIDED|95.0|2.38|8.89|||Regression, Logistic|Logistic regression using non-responder imputation||Proportion of patients with ACR 20 response at Week 12 (FAS)||8.89|2.38|<0.0001
74037277|NCT02662985|147627766|SUPERIORITY||Odds Ratio (OR)|9.65|||<|0.0001|TWO_SIDED|95.0|3.92|23.75|||Regression, Logistic|||Proportion of patients with ACR 50 response at Week 12 (FAS)||23.75|3.92|<0.0001
74037278|NCT02662985|147627767|SUPERIORITY||Adjusted mean of treatment difference|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0327|TWO_SIDED|95.0|-1.374|0.043|||Regression, Logistic|||SPARCC||0.043|-1.374|0.0327
74002312|NCT03881553|147553053|OTHER|Post Hoc Wilcoxon||||||0.021||||||ON1 compared to OFF2|Wilcoxon (Mann-Whitney)|||||||0.021
74002313|NCT01959516|147553057|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||||||0.0250
74002314|NCT01959516|147553058|SUPERIORITY_OR_OTHER|||||||0.1439|||||||Mixed Models Analysis|||||||0.1439
74002315|NCT02481947|147553121|NON_INFERIORITY|Non-inferiority margin = 12.6% (pre-specified)||||||0.016||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|||||||0.016
74002316|NCT01815138|147553123|OTHER||Odds Ratio (OR)|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
74002317|NCT01815138|147553124|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
74002318|NCT03426267|147553126|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74002319|NCT03426267|147553127|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74002320|NCT04619251|147553141|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|337.6|||||TWO_SIDED|90.0|302.8|376.4|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =15.9|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||376.4|302.8|
74002321|NCT04619251|147553142|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|184.4|||||TWO_SIDED|90.0|156.0|218.0|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =26.4|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||218.0|156.0|
74002322|NCT04619251|147553143|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|356.8|||||TWO_SIDED|90.0|315.7|403.2|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =18.4|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||403.2|315.7|
74002323|NCT00803751|147553152|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Fisher Exact|||||||0.17
73877864|NCT03040141|147295362|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.463|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.463
73877865|NCT03040141|147295363|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.152|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.152
73877866|NCT03040141|147295363|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.176|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.176
73877867|NCT03040141|147295363|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.157|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.157
74002324|NCT00803751|147553153|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Fisher Exact|||||||0.45
74037279|NCT01486784|147627774|OTHER||||||||||||||||||Based on the dose limiting toxicities occurring in each dosing cohort, a maximum tolerated dose (MTD) may be determined by assessing the highest dosing level presenting no dose limiting toxicities. An MTD of 17mg/m2 twice weekly was established.|||
74037280|NCT01021852|147627780|SUPERIORITY_OR_OTHER||Difference in LS Means|8.4|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.3|11.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||11.5|5.3|<0.001
74037281|NCT01021852|147627780|SUPERIORITY_OR_OTHER||Difference in LS Means|9.9|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|6.8|13.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||13.1|6.8|<0.001
74090902|NCT02037165|147735936|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.04|STANDARD_ERROR_OF_MEAN|2.0282|||TWO_SIDED|95.0|-5.0|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-5.0|
73877868|NCT03040141|147295363|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.844|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.844
73877869|NCT03040141|147295364|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.531|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.531
73877870|NCT03040141|147295364|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.582|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.582
73877871|NCT03040141|147295364|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.55|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.550
73877872|NCT03040141|147295364|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.84|||||||Chi-squared|P-value determined based on Cox proportional hazards model Wald Chi-Square Statistic.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.840
74002325|NCT00803751|147553154|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
74002326|NCT00803751|147553155|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||||||0.002
73877873|NCT03040141|147295365|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.3534|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.3534
73877874|NCT03040141|147295365|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.7839|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.7839
74002327|NCT00803751|147553156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
74002328|NCT00803751|147553157|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||||||0.0004
74002329|NCT03102645|147553158|SUPERIORITY||Mean Difference (Final Values)|6.5||||0.07|TWO_SIDED|95.0|-0.5|13.5|||t-test, 2 sided|CROS. DF=14.||CROS test||13.5|-0.5|0.07
74002330|NCT03102645|147553159|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.03|TWO_SIDED|95.0|2.0|28.2|||t-test, 2 sided|CROS test||CROS test||28.2|2.0|0.03
74002331|NCT01413087|147553160|SUPERIORITY|||||||0.483|||||||Log Rank|P value by log-rank test for the difference between treatment groups||||||0.483
74002332|NCT01413087|147553161|SUPERIORITY|||||||0.992|||||||Log Rank|P value by log-rank test for the difference between treatment groups||||||0.992
74002333|NCT00998335|147553188|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANOVA|||Baseline versus 3 months||||0.03
74002334|NCT02390050|147553227|SUPERIORITY||Difference of LS Means|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.34||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.34|-0.76|< 0.0001
74002335|NCT02390050|147553227|SUPERIORITY||Difference of LS Means|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.89|-0.47||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.47|-0.89|< 0.0001
74002336|NCT02390050|147553227|SUPERIORITY||Difference of LS Means|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.01|-0.59||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.59|-1.01|< 0.0001
74002337|NCT02390050|147553228|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1308|TWO_SIDED|95.0|0.8|5.3|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 5 mg bexagliflozin group was compared to placebo group.||5.3|0.8|0.1308
74002338|NCT02390050|147553228|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1294|TWO_SIDED|95.0|0.8|5.1|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 10 mg bexagliflozin group was compared to placebo group.||5.1|0.8|0.1294
74002339|NCT02390050|147553228|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0015|TWO_SIDED|95.0|1.7|10.3|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 20 mg bexagliflozin group was compared to placebo group.||10.3|1.7|0.0015
74039824|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.14||0.0336|TWO_SIDED|95.0|-0.55|-0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.55|0.0336
74002340|NCT02390050|147553229|SUPERIORITY||Difference of LS Means|-0.74|||||TWO_SIDED|95.0|-1.13|-0.36||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.36|-1.13|
74002341|NCT02390050|147553229|SUPERIORITY||Difference of LS Means|-0.76|||||TWO_SIDED|95.0|-1.15|-0.38||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.38|-1.15|
74002342|NCT02390050|147553229|SUPERIORITY||Difference of LS Means|-0.99|||||TWO_SIDED|95.0|-1.38|-0.61||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.61|-1.38|
74002343|NCT02390050|147553229|SUPERIORITY||Difference of LS Means|-1.02|||||TWO_SIDED|95.0|-1.53|-0.52||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.52|-1.53|
74002344|NCT02390050|147553229|SUPERIORITY||Difference of LS Means|-1.45|||||TWO_SIDED|95.0|-1.95|-0.94||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.94|-1.95|
74002345|NCT02390050|147553229|SUPERIORITY||Difference of LS Means|-1.51|||||TWO_SIDED|95.0|-2.01|-1.01||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-1.01|-2.01|
74002346|NCT02390050|147553229|SUPERIORITY||Difference of LS Means|-1.44|||<|0.0001|TWO_SIDED|95.0|-2.12|-0.76||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.76|-2.12|< 0.0001
74002347|NCT02390050|147553229|SUPERIORITY||Difference of LS Means|-1.59|||<|0.0001|TWO_SIDED|95.0|-2.26|-0.91||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.91|-2.26|< 0.0001
73877875|NCT03040141|147295365|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.4893|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.4893
74002348|NCT02390050|147553229|SUPERIORITY||Difference of LS Means|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.43|-1.08||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-1.08|-2.43|< 0.0001
74002349|NCT02390050|147553230|SUPERIORITY||Difference of LS Means|-0.48|||||TWO_SIDED|95.0|-0.9|-0.06||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.06|-0.90|
74002350|NCT02390050|147553230|SUPERIORITY||Difference of LS Means|-0.9|||||TWO_SIDED|95.0|-1.31|-0.48||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.48|-1.31|
74002351|NCT02390050|147553230|SUPERIORITY||Difference of LS Means|-1.04|||||TWO_SIDED|95.0|-1.45|-0.62||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.62|-1.45|
74002352|NCT02390050|147553230|SUPERIORITY||Difference of LS Means|-0.93|||||TWO_SIDED|95.0|-1.39|-0.48||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.48|-1.39|
74002353|NCT02390050|147553230|SUPERIORITY||Difference of LS Means|-1.17|||||TWO_SIDED|95.0|-1.62|-0.72||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.72|-1.62|
74002354|NCT02390050|147553230|SUPERIORITY||Difference of LS Means|-1.1|||||TWO_SIDED|95.0|-1.55|-0.65||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.65|-1.55|
74002355|NCT02390050|147553230|SUPERIORITY||Difference of LS Means|-0.85||||0.0002|TWO_SIDED|95.0|-1.29|-0.41||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.41|-1.29|0.0002
74002356|NCT02390050|147553230|SUPERIORITY||Difference of LS Means|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.49|-0.6||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.60|-1.49|< 0.0001
73877876|NCT03040141|147295365|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.5101|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.5101
74002357|NCT02390050|147553230|SUPERIORITY||Difference of LS Means|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.52|-0.63||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.63|-1.52|< 0.0001
74037282|NCT01021852|147627780|SUPERIORITY_OR_OTHER||Difference in LS Means|10.7|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|7.7|13.8|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||13.8|7.7|<0.001
73877877|NCT03040141|147295366|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.5436|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.5436
73877878|NCT03040141|147295366|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.8215|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.8215
74002358|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-0.19|||||TWO_SIDED|95.0|-3.9|3.51||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||3.51|-3.90|
74002359|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-2.41|||||TWO_SIDED|95.0|-6.09|1.28||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.28|-6.09|
74002360|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-4.25|||||TWO_SIDED|95.0|-7.93|-0.58||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.58|-7.93|
74002361|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-0.18|||||TWO_SIDED|95.0|-2.5|2.13||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.13|-2.50|
74002362|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-1.74|||||TWO_SIDED|95.0|-4.03|0.56||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||0.56|-4.03|
74002363|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-2.15|||||TWO_SIDED|95.0|-4.45|0.14||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.14|-4.45|
73877879|NCT03040141|147295366|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.6319|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.6319
73877880|NCT03040141|147295366|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.7011|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.7011
73877881|NCT03040141|147295367|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.478|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.478
74002364|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-0.84|||||TWO_SIDED|95.0|-4.57|2.9||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.90|-4.57|
74002365|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-3.39|||||TWO_SIDED|95.0|-7.12|0.34||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||0.34|-7.12|
74002366|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-2.51|||||TWO_SIDED|95.0|-6.21|1.2||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||1.20|-6.21|
74002367|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|0.25|||||TWO_SIDED|95.0|-2.15|2.66||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.66|-2.15|
74002368|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-1.02|||||TWO_SIDED|95.0|-3.42|1.38||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.38|-3.42|
74090903|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.94|STANDARD_ERROR_OF_MEAN|1.8566|||TWO_SIDED|95.0|-4.6|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-4.6|
74002369|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-0.84|||||TWO_SIDED|95.0|-3.22|1.54||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||1.54|-3.22|
74090904|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.87|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-6.5|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-6.5|
74090905|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.08|STANDARD_ERROR_OF_MEAN|1.8557|||TWO_SIDED|95.0|-6.7|0.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-6.7|
74002370|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-2.16||||0.3001|TWO_SIDED|95.0|-6.26|1.94||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||1.94|-6.26|0.3001
74002371|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-4.41||||0.0343|TWO_SIDED|95.0|-8.49|-0.33||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.33|-8.49|0.0343
74002372|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-3.83||||0.0679|TWO_SIDED|95.0|-7.95|0.28|||ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.28|-7.95|0.0679
74002373|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-2.24||||0.0776|TWO_SIDED|95.0|-4.73|0.25||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||0.25|-4.73|0.0776
74002374|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-1.47||||0.2415|TWO_SIDED|95.0|-3.95|1.0||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.00|-3.95|0.2415
74037283|NCT01021852|147627780|SUPERIORITY_OR_OTHER||Difference in LS Means|13.4|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|10.3|16.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||16.5|10.3|<0.001
74037284|NCT01021852|147627780|SUPERIORITY_OR_OTHER||Difference in LS Means|4.6|STANDARD_ERROR_OF_MEAN|1.42||0.001|TWO_SIDED|95.0|1.8|7.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||7.4|1.8|0.001
74037285|NCT01021852|147627780|SUPERIORITY_OR_OTHER||Difference in LS Means|4.1|STANDARD_ERROR_OF_MEAN|1.42||0.004|TWO_SIDED|95.0|1.3|6.9|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||6.9|1.3|0.004
73877882|NCT03040141|147295367|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.468|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.468
74037286|NCT01021852|147627780|SUPERIORITY_OR_OTHER||Difference in LS Means|9.7|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|6.9|12.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||12.5|6.9|<0.001
74037287|NCT01021852|147627780|SUPERIORITY_OR_OTHER||Difference in LS Means|8.7|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|5.9|11.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||11.5|5.9|<0.001
73957218|NCT04771273|147450408|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957219|NCT04771273|147450408|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957220|NCT04771273|147450408|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957221|NCT04771273|147450408|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957222|NCT04771273|147450408|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
74002375|NCT02390050|147553231|SUPERIORITY||Difference of LS Means|-2.04||||0.1086|TWO_SIDED|95.0|-4.54|0.46||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.46|-4.54|0.1086
74002376|NCT02390050|147553232|SUPERIORITY||Difference of LS Means|-0.09|||||TWO_SIDED|95.0|-0.2|0.03||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||0.03|-0.20|
73877883|NCT03040141|147295367|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.412|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.412
74090906|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.63|STANDARD_ERROR_OF_MEAN|1.8555|||TWO_SIDED|95.0|-5.3|2.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.0|-5.3|
73877884|NCT03040141|147295367|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.982|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.982
73957223|NCT04771273|147450408|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957224|NCT04771273|147450409|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|10.39|||<|0.0001|TWO_SIDED|95.0|4.6|23.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||23.45|4.60|<.0001
73957225|NCT04771273|147450409|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|12.06|||<|0.0001|TWO_SIDED|95.0|5.3|27.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||27.45|5.30|<.0001
73957226|NCT04771273|147450409|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|8.22|||<|0.0001|TWO_SIDED|95.0|3.66|18.5||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||18.50|3.66|<.0001
73957227|NCT04771273|147450409|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957228|NCT04771273|147450409|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0031|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0031
74002377|NCT02390050|147553232|SUPERIORITY||Difference of LS Means|-0.13|||||TWO_SIDED|95.0|-0.24|-0.02||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.02|-0.24|
74002378|NCT02390050|147553232|SUPERIORITY||Difference of LS Means|-0.13|||||TWO_SIDED|95.0|-0.24|-0.02||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.02|-0.24|
74002379|NCT02390050|147553232|SUPERIORITY||Difference of LS Means|-0.45|||||TWO_SIDED|95.0|-0.62|-0.28||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.28|-0.62|
74002380|NCT02390050|147553232|SUPERIORITY||Difference of LS Means|-0.49|||||TWO_SIDED|95.0|-0.66|-0.32||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.32|-0.66|
74002381|NCT02390050|147553232|SUPERIORITY||Difference of LS Means|-0.53|||||TWO_SIDED|95.0|-0.7|-0.36||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.36|-0.70|
74002382|NCT02390050|147553232|SUPERIORITY||Difference of LS Means|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.34||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.34|-0.76|< 0.0001
74002383|NCT02390050|147553232|SUPERIORITY||Difference of LS Means|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.89|-0.47||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.47|-0.89|< 0.0001
74002384|NCT02390050|147553232|SUPERIORITY||Difference of LS Means|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.01|-0.59||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.59|-1.01|< 0.0001
74002385|NCT00346268|147553233|SUPERIORITY_OR_OTHER||least square (LS) mean difference (net)|-7.58|STANDARD_ERROR_OF_MEAN|3.55||0.035|TWO_SIDED|95.0|-14.63|-0.53||Adjusted for treatment group and center|ANOVA|||||-0.53|-14.63|0.035
74002386|NCT00346268|147553234|SUPERIORITY_OR_OTHER||least square (LS) mean difference (net)|-15.16|STANDARD_ERROR_OF_MEAN|5.2||0.004|TWO_SIDED|95.0|-25.47|-4.85||Adjusted for treatment group and center|ANOVA|||||-4.85|-25.47|0.004
74002387|NCT00346268|147553235|SUPERIORITY_OR_OTHER|||||||0.257||95.0|||||Log Rank|Stratified by center||||||0.257
74002388|NCT00346268|147553236|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.07|STANDARD_ERROR_OF_MEAN|0.3||0.81|TWO_SIDED|95.0|-0.68|0.53||Adjusted for treatment group and center|ANCOVA|Covariates:Total RBCUs and RBCUs substituted during surgery, baseline hemoglobin, swab and lavage weights, intraoperative blood loss fluid volume||||0.53|-0.68|0.810
74002389|NCT00346268|147553238|SUPERIORITY_OR_OTHER||Least squares mean difference (net)|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED|95.0|-0.01|0.35|||ANOVA|||The difference in pain at rest prior to administration and pain at rest post administration compared between treatments at 48 hours post surgery.||0.35|-0.01|0.070
74002390|NCT00346268|147553238|SUPERIORITY_OR_OTHER||LS Mean Difference (net)|0.16|STANDARD_ERROR_OF_MEAN|0.09||0.074|TWO_SIDED|95.0|-0.02|0.33|||ANOVA|||The difference in pain at movement prior to administration and pain at movement post administration compared between treatments at 48 hours post surgery.||0.33|-0.02|0.074
74002391|NCT00346268|147553239|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.71|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.16|-0.26||Adjusted for treatment group and center|ANOVA|||24 hours post surgery||-0.26|-1.16|0.002
74002392|NCT00346268|147553239|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.73|STANDARD_ERROR_OF_MEAN|0.25||0.004|TWO_SIDED|95.0|-1.22|-0.23||Adjusted for treatment group and center|ANOVA|||48 hours post surgery||-0.23|-1.22|0.004
74002393|NCT00346268|147553240|SUPERIORITY_OR_OTHER||LS mean difference (net)|-1.16|STANDARD_ERROR_OF_MEAN|0.3||0.001|TWO_SIDED|95.0|-1.77|-0.56||Adjusted for treatment group and center|ANOVA|||24 hours post surgery||-0.56|-1.77|0.001
74002394|NCT00346268|147553240|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.83|STANDARD_ERROR_OF_MEAN|0.3||0.006|TWO_SIDED|95.0|-1.41|-0.24||Adjusted for treatment group and center|ANOVA|||48 hours post surgery||-0.24|-1.41|0.006
74002395|NCT03536143|147553270|SUPERIORITY|||||||0.0216|||||||Log Rank|||||||0.0216
74002396|NCT03536143|147553271|SUPERIORITY|||||||0.0009|||||||Log Rank|||||||0.0009
74002397|NCT02527343|147553273|SUPERIORITY||Difference in Least Square Mean|-66.83||||0.0009|TWO_SIDED|95.0|-104.17|-29.48|||ANCOVA|||||-29.48|-104.17|0.0009
74002398|NCT02527343|147553274|SUPERIORITY||Difference in Least Square Mean|-25.69||||0.0736|TWO_SIDED|95.0|-54.03|2.65|||ANCOVA|||Month 6||2.65|-54.03|0.0736
74002399|NCT02527343|147553274|SUPERIORITY||Difference in Least Square Mean|-53.33||||0.0039|TWO_SIDED|95.0|-87.71|-18.95|||ANCOVA|||Month 12||-18.95|-87.71|0.0039
74002400|NCT02527343|147553276|SUPERIORITY||Difference in Least Square Mean|0.3||||0.4108|TWO_SIDED|95.0|-0.43|1.03|||ANCOVA|||Month 3||1.03|-0.43|0.4108
74002401|NCT02527343|147553276|SUPERIORITY||Difference in Least Square Mean|0.19||||0.7308|TWO_SIDED|95.0|-0.95|1.34|||ANCOVA|||Month 6||1.34|-0.95|0.7308
74002402|NCT02527343|147553276|SUPERIORITY||Difference in Least Square Mean|-0.2||||0.7511|TWO_SIDED|95.0|-1.45|1.06|||ANCOVA|||Month 9||1.06|-1.45|0.7511
74002403|NCT02527343|147553276|SUPERIORITY||Difference in Least Square Mean|-0.19||||0.7659|TWO_SIDED|95.0|-1.52|1.13|||ANCOVA|||Month 12||1.13|-1.52|0.7659
74002404|NCT00701220|147553290|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||The data were analyzed using analysis of variance for repeated measures with two groups. The repeated measure was the proportion of circulating blood cells that were positive for aldehyde dehydrogenase using the commercially available Aldofluor assay. The two groups were those with ischemic and non-ischemic cardiomyopathy. This analysis permitted both intergroup and intragroup analysis of the change in aldehyde dehydrogenase positive cells.||||<0.05
74002405|NCT00440999|147553291|NON_INFERIORITY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the crude cure rate on Day 14 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction) and a 10% non-inferiority margin. Non-inferiority was claimed if the lower limit of the 2-sided 95% CI for the difference in cure rates on Day 14 was \>10%.|Difference in cure rate|-0.5|||||TWO_SIDED|95.0|-2.6|1.4|||||Conclusion: non-inferiority between PA \& chloroquine.|"Null hypothesis: The cure rate on Day 14 for the PA group is inferior to the cure rate on Day 14 for the chloroquine group by more than 10%.~Was tested against the alternative:~Alternative hypothesis: The cure rate on Day 14 for the PA group was not inferior to the cure rate on Day 14 for the chloroquine group by more than 10%."||1.4|-2.6|
74002406|NCT04745026|147553300|SUPERIORITY||Least square mean difference|3.37|STANDARD_ERROR_OF_MEAN|1.931|=|0.085|TWO_SIDED|95.0|-0.48|7.21||Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).|Mixed models for repeated measures|||Irritability (Week 12)||7.21|-0.48|=0.085
74002407|NCT04745026|147553300|SUPERIORITY||Least square mean difference|1.14|STANDARD_ERROR_OF_MEAN|1.16|=|0.3107|TWO_SIDED|95.0|-1.08|3.36|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Social Withdrawal Week 12)||3.36|-1.08|=0.3107
74002408|NCT04745026|147553300|SUPERIORITY||Least square mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.695|=|0.9513|TWO_SIDED|95.0|-1.34|1.42|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Stereotypic Behavior (Week 12)||1.42|-1.34|=0.9513
74002409|NCT04745026|147553300|SUPERIORITY||Least square mean difference|2.01|STANDARD_ERROR_OF_MEAN|1.943|=|0.305|TWO_SIDED|95.0|-1.86|5.88|||Mixed models repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Hyperactivity/Noncompliance (Week 12)||5.88|-1.86|=0.305
74002410|NCT04745026|147553300|SUPERIORITY||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.517|=|0.4754|TWO_SIDED|95.0|-1.4|0.66|||Mixed models repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Inappropriate Speech (Week 12)||0.66|-1.4|=0.4754
74037288|NCT01021852|147627781|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.8|STANDARD_ERROR_OF_MEAN|6.29|<|0.001|TWO_SIDED|95.0|-43.2|-18.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.4|-43.2|<0.001
74037289|NCT01021852|147627781|SUPERIORITY_OR_OTHER||Difference in LS Means|-32.5|STANDARD_ERROR_OF_MEAN|6.31|<|0.001|TWO_SIDED|95.0|-44.9|-20.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-20.1|-44.9|<0.001
74037290|NCT01021852|147627781|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.9|STANDARD_ERROR_OF_MEAN|6.21|<|0.001|TWO_SIDED|95.0|-43.2|-18.7|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.7|-43.2|<0.001
74037291|NCT01021852|147627781|SUPERIORITY_OR_OTHER||Difference in LS Means|-45.8|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-58.0|-33.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-33.5|-58.0|<0.001
74037292|NCT01021852|147627781|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.5|STANDARD_ERROR_OF_MEAN|5.65||0.006|TWO_SIDED|95.0|-26.7|-4.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-4.4|-26.7|0.006
74037293|NCT01021852|147627781|SUPERIORITY_OR_OTHER||Difference in LS Means|-13.2|STANDARD_ERROR_OF_MEAN|5.66||0.02|TWO_SIDED|95.0|-24.4|-2.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-2.1|-24.4|0.020
74037294|NCT01021852|147627781|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.7|STANDARD_ERROR_OF_MEAN|5.67|<|0.001|TWO_SIDED|95.0|-36.8|-14.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-14.5|-36.8|<0.001
74037295|NCT01021852|147627781|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.0|STANDARD_ERROR_OF_MEAN|5.69|<|0.001|TWO_SIDED|95.0|-41.2|-18.8|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.8|-41.2|<0.001
74037296|NCT01021852|147627782|SUPERIORITY_OR_OTHER||Difference in LS Means|-10.2|STANDARD_ERROR_OF_MEAN|4.43||0.022|TWO_SIDED|95.0|-18.9|-1.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-1.5|-18.9|0.022
73877885|NCT03318549|147295385|OTHER|||||||0.011|||||||t-test, 2 sided|||||||0.011
73877886|NCT03318549|147295385|OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
73877887|NCT03318549|147295386|OTHER|||||||0.303|||||||Chi-squared|||||||0.303
74002411|NCT04745026|147553301|SUPERIORITY||Least square mean difference|0.45|STANDARD_ERROR_OF_MEAN|2.36|=|0.8506|TWO_SIDED|95.0|-4.26|5.15|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Week 12||5.15|-4.26|=0.8506
74002412|NCT04745026|147553302|SUPERIORITY||Odds Ratio (OR)|1.22|||=|0.7087|TWO_SIDED|95.0|0.43|3.51|||Regression, Logistic|Includes treatment arm, randomization variables and baseline score (CGI-S) covariates. Responders achieved a score of 1 or 2 at post-baseline visits.||Responders with 'Very Much Improved' or 'Much Improved' response at week 12||3.51|0.43|=0.7087
74002413|NCT04745026|147553303|SUPERIORITY||||||=|0.6108|||||||Cochran-Mantel-Haenszel|||Week 12||||=0.6108
74002414|NCT04426851|147553314|OTHER||Ratio of the geometric means (%)|45.9|||||TWO_SIDED|90.0|41.4|50.9|||||"Ratio was calculated as: BI 1358894 100 mg tablet fasted/BI 1358894 (C-14) 100 ug i.v.~Intra-individual geometric coefficient of variation (gCV)=14.3."|The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed.||50.9|41.4|
74002415|NCT04426851|147553315|OTHER||Ratio of the geometric means (%)|141.4|||||TWO_SIDED|90.0|129.3|154.6|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra -individual geometric coefficient of variation (gCV)=10.9.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||154.6|129.3|
74002416|NCT04426851|147553317|OTHER||Ratio of the geometric means (%)|65.3|||||TWO_SIDED|90.0|54.6|78.0|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV)=22.5.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||78.0|54.6|
73877888|NCT03318549|147295389|OTHER|||||||0.132|||||||t-test, 2 sided|||||||0.132
73877889|NCT03318549|147295389|OTHER|||||||0.647|||||||t-test, 2 sided|||||||0.647
73877890|NCT00462306|147295396|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||4000 parturients and 500 non-pregnant achieves 90% power to detect a difference of 3% positive Berlin Questionnaire rates between pregnant and non-pregnant women using a two sided chi squared test at a significance level of 0.05|Chi-squared, Corrected|||We hypothesized that the rate of positive Berlin questionnaires would be higher in pregnant women compared to age matched controls undergoing surgery.||||0.001
73877891|NCT00462306|147295397|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
73877892|NCT03515824|147295398|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|0.0|||||TWO_SIDED|80.0|0.0|33.1||||||||33.1|0.0|
73877893|NCT03515824|147295398|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|0.0|||||TWO_SIDED|80.0|0.0|33.1||||||||33.1|0.0|
74002417|NCT04426851|147553318|OTHER||Ratio of the geometric means (%)|148.4|||||TWO_SIDED|90.0|138.1|159.5|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV) =8.7.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||159.5|138.1|
74002418|NCT01778023|147553332|SUPERIORITY_OR_OTHER||Treatment Difference|5.15|||<|0.0001|TWO_SIDED|95.0|4.09|6.21|||ANOVA|The HV after 6 months of treatment was analysed using an ANCOVA method with group and sex as fixed effects, and age as a covariate.||Let D be a mean difference of the primary endpoint between group A and group B. Null hypothesis H0: D = 0 vs. alternative H1: D ≠ 0 will be statistically tested by an ANOVA model.||6.21|4.09|<0.0001
74002419|NCT03086213|147553345|NON_INFERIORITY|the definition of non-inferiority analysis is that the new method is no less effective than standard interventions.|Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|0.025||0.025|TWO_SIDED|95.0|5.0|95.0||whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance|t-test, 2 sided|degrees of freedom|Paravertebral nerve block arm represents the numerator and intercostal block represents the denominator for relative risk|null hypothesis||95|5|0.025
74002420|NCT03086213|147553346|SUPERIORITY|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level|||||<|0.05||||||the p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance.|t-test, 2 sided|degrees of freedom is defined as sample size subtraction one.||null hypothesis||||<0.05
74002421|NCT03086213|147553349|SUPERIORITY|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level||||||0.05|||||||t-test, 2 sided|Degree of freedom is defined as sample size subtraction one.||null hypothesis||||0.05
74002422|NCT00819390|147553374|SUPERIORITY_OR_OTHER|||||||0.428||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.||||0.428
74002423|NCT00819390|147553374|SUPERIORITY_OR_OTHER|||||||0.247||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments.||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.||||0.247
74002424|NCT01270971|147553410|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
74002425|NCT01270971|147553411|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74002426|NCT01270971|147553412|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74002427|NCT01270971|147553413|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74002428|NCT02411357|147553414|SUPERIORITY||||||<|0.001|||||||Cochran-Armitage Chi-square trend test|||||||<.001
73877894|NCT03515824|147295398|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|15.4|||||TWO_SIDED|80.0|5.8|30.2||||||||30.2|5.8|
73877895|NCT03515824|147295401|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|70.8||||||||70.8|0.0|
74002429|NCT01588496|147553423|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-29.78|STANDARD_ERROR_OF_MEAN|5.54|<|0.001|TWO_SIDED|95.0|-40.94|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-18.62|-40.94|<0.001
74002430|NCT01588496|147553424|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-23.14|STANDARD_ERROR_OF_MEAN|5.81|<|0.001|TWO_SIDED|95.0|-34.83|-11.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-11.45|-34.83|<0.001
74002431|NCT01588496|147553425|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.89|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-33.72|-12.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-12.05|-33.72|<0.001
74002432|NCT01588496|147553426|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.83|STANDARD_ERROR_OF_MEAN|6.77||0.088|TWO_SIDED|95.0|-25.48|1.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||1.82|-25.48|0.088
74002433|NCT01588496|147553427|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.27|STANDARD_ERROR_OF_MEAN|5.86||0.088|TWO_SIDED|95.0|-23.11|0.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||0.56|-23.11|0.088
74002434|NCT01588496|147553428|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-30.93|STANDARD_ERROR_OF_MEAN|6.42|<|0.001|TWO_SIDED|95.0|-43.86|-18.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|LDL-C lowering was analyzed by comparing evolocumab and placebo. Statistical analysis was 2-sided with a significance level of 0.05.||-18.00|-43.86|<0.001
74037297|NCT01021852|147627782|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.7|STANDARD_ERROR_OF_MEAN|4.44|<|0.001|TWO_SIDED|95.0|-24.5|-7.0|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-7.0|-24.5|<0.001
74039825|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.14||0.0008|TWO_SIDED|95.0|-0.73|-0.19|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.19|-0.73|0.0008
73877896|NCT03515824|147295401|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|60.2||||||||60.2|0.0|
74002435|NCT01551212|147553429|SUPERIORITY||Mean Difference (Final Values)|4.09||||0.097|TWO_SIDED|95.0|-0.74|8.91|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \> 30) covariate: baseline value||||8.91|-0.74|0.097
73877897|NCT03515824|147295401|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|21.8||||||||21.8|0.0|
73877898|NCT03515824|147295402|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|84.2||||||||84.2|0.0|
74002436|NCT01551212|147553430|SUPERIORITY||Mean Difference (Final Values)|7.99||||0.0085|TWO_SIDED|95.0|2.06|13.92|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \> 30) covariate: baseline value||||13.92|2.06|0.0085
74002437|NCT01551212|147553431|SUPERIORITY|||||||0.699|||||||Fisher Exact|||||||0.699
74002438|NCT00705523|147553436|SUPERIORITY_OR_OTHER|||||||0.1|||||||Regression, Logistic|beta=-0.67, exp(beta)=0.51, chi-squared(1) = 0.2.71||Self-reported drinking results, as gathered by the TLFB, were compared by the generalized estimating equations (GEE) (Diggle et al., 1994), using Poisson models for counts of drinking and heavy drinking days, and logistic regression models for absence/presence binary indicators of drinking. In the GEE model, the pre-treatment of the response was included as a covariate, together with the treatment group indicator, and a linear time effect.||||0.10
74002439|NCT01242800|147553486|SUPERIORITY|||||||0.32|||||||Log Rank|Stratified log rank test was used for arm comparison||||||0.32
73877899|NCT03515824|147295402|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|70.8||||||||70.8|0.0|
73877900|NCT03515824|147295402|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate )ORR)|0.0|||||TWO_SIDED|95.0|0.0|28.5||||||||28.5|0.0|
74002440|NCT00953745|147553489|SUPERIORITY_OR_OTHER|||||||0.029||||||paired t-test thresholded at cluster level significance of p=0.001; family-wise error multiple comparisons corrected|t-test, 1 sided|||A region of increased relative Fluorodopa (FDOPA) uptake in the right medial caudate was anticipated for the aripiprazole augmentation responders over the 6 weeks of augmentation treatment (Weeks 10-16).||||0.029
73877901|NCT00539994|147295422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73877902|NCT00539994|147295422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
74037298|NCT01021852|147627782|SUPERIORITY_OR_OTHER||Difference in LS Means|-23.5|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-32.1|-14.9|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-14.9|-32.1|<0.001
74037299|NCT01021852|147627782|SUPERIORITY_OR_OTHER||Difference in LS Means|-20.3|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-29.0|-11.7|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-11.7|-29.0|<0.001
74002441|NCT00953745|147553490|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74002442|NCT00953745|147553490|SUPERIORITY_OR_OTHER|||||||0.366|||||||t-test, 2 sided|||||||0.366
74002443|NCT02640157|147553494|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||TWO_SIDED|95.0|-5.6|3.1||||||Difference in SVR12 rates (Arm A - Arm B).||3.1|-5.6|
74002444|NCT02640157|147553494|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|percentage of participants|95.3|||||TWO_SIDED|97.5|92.2|98.4||||||||98.4|92.2|
74002445|NCT02640157|147553494|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||TWO_SIDED|97.5|-6.2|3.7||||||Difference in SVR12 rates (Arm A - Arm B).||3.7|-6.2|
74002446|NCT02640157|147553495|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||TWO_SIDED|95.0|-4.8|4.0||||||Difference in SVR12 rates (Arm C - Arm A)||4.0|-4.8|
74002447|NCT02640157|147553495|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Percentage of participants|94.9|||||TWO_SIDED|97.5|91.0|98.8||||||||98.8|91.0|
74002448|NCT02640157|147553495|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||TWO_SIDED|97.5|-5.4|4.6||||||||4.6|-5.4|
74002449|NCT04677179|147553508|SUPERIORITY||Odds Ratio (OR)|0.57||||0.75|TWO_SIDED|95.0|0.03|11.32|||Cochran-Mantel-Haenszel|||||11.32|0.03|0.750
74002450|NCT04677179|147553508|SUPERIORITY||Odds Ratio (OR)|0.8||||0.838|TWO_SIDED|95.0|0.1|6.21|||Cochran-Mantel-Haenszel|||||6.21|0.10|0.838
74002451|NCT04677179|147553509|SUPERIORITY||Odds Ratio (OR)|0.57||||0.563|TWO_SIDED|95.0|0.1|3.3|||Cochran-Mantel-Haenszel|||||3.30|0.10|0.563
74002452|NCT04677179|147553509|SUPERIORITY||Odds Ratio (OR)|0.78||||0.759|TWO_SIDED|95.0|0.17|3.64|||Cochran-Mantel-Haenszel|||||3.64|0.17|0.759
74002453|NCT04677179|147553510|SUPERIORITY||Odds Ratio (OR)|0.18||||0.163|TWO_SIDED|95.0|0.02|1.93|||Cochran-Mantel-Haenszel|||||1.93|0.02|0.163
74002454|NCT04677179|147553510|SUPERIORITY||Odds Ratio (OR)|0.54||||0.439|TWO_SIDED|95.0|0.11|2.77|||Cochran-Mantel-Haenszel|||||2.77|0.11|0.439
74002455|NCT04677179|147553511|SUPERIORITY||Odds Ratio (OR)|1.29||||0.821|TWO_SIDED|95.0|0.17|9.88|||Cochran-Mantel-Haenszel|||||9.88|0.17|0.821
74002456|NCT04677179|147553511|SUPERIORITY||Odds Ratio (OR)|1.43||||0.572|TWO_SIDED|95.0|0.37|5.49|||Cochran-Mantel-Haenszel|||||5.49|0.37|0.572
74002457|NCT04677179|147553512|SUPERIORITY||Odds Ratio (OR)|1.18||||0.886|TWO_SIDED|95.0|0.14|10.16|||Cochran-Mantel-Haenszel|||||10.16|0.14|0.886
74002458|NCT04677179|147553512|SUPERIORITY||Odds Ratio (OR)|0.78||||0.784|TWO_SIDED|95.0|0.14|4.18|||Cochran-Mantel-Haenszel|||||4.18|0.14|0.784
74002459|NCT04677179|147553513|SUPERIORITY||Odds Ratio (OR)|0.37||||0.331|TWO_SIDED|95.0|0.06|2.43|||Cochran-Mantel-Haenszel|||||2.43|0.06|0.331
74002460|NCT04677179|147553513|SUPERIORITY||Odds Ratio (OR)|0.51||||0.407|TWO_SIDED|95.0|0.1|2.52|||Cochran-Mantel-Haenszel|||||2.52|0.10|0.407
73957229|NCT04771273|147450409|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0925|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0925
73957230|NCT04771273|147450409|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957231|NCT04771273|147450409|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957232|NCT04771273|147450409|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
73957233|NCT04771273|147450410|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-8.59|||<|0.0001|TWO_SIDED|95.0|-10.59|-6.6||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-6.60|-10.59|<.0001
73957234|NCT04771273|147450410|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.91|||<|0.0001|TWO_SIDED|95.0|-12.96|-8.86||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.86|-12.96|<.0001
73957235|NCT04771273|147450410|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-11.07|||<|0.0001|TWO_SIDED|95.0|-13.23|-8.92||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.92|-13.23|<.0001
74002461|NCT04677179|147553514|SUPERIORITY||Risk Ratio (RR)|1.5||||0.564|TWO_SIDED|95.0|0.38|6.0|||Cochran-Mantel-Haenszel|||||6.00|0.38|0.564
74002462|NCT04677179|147553514|SUPERIORITY||Risk Ratio (RR)|1.51||||0.681|TWO_SIDED|95.0|0.21|10.97|||Cochran-Mantel-Haenszel|||||10.97|0.21|0.681
74002463|NCT04677179|147553515|SUPERIORITY||Risk Difference (RD)|3.6||||0.317|TWO_SIDED|95.0|-3.3|10.4|||Cochran-Mantel-Haenszel|||||10.4|-3.3|0.317
74002464|NCT04677179|147553515|SUPERIORITY||Risk Difference (RD)|6.9||||0.238|TWO_SIDED|95.0|-2.3|16.1|||Cochran-Mantel-Haenszel|||||16.1|-2.3|0.238
74002465|NCT04677179|147553516|SUPERIORITY||LS Mean Difference|9.71|STANDARD_ERROR_OF_MEAN|10.935||0.378|TWO_SIDED|95.0|-12.17|31.6|||ANCOVA|||||31.60|-12.17|0.378
74002466|NCT04677179|147553516|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|10.406||0.928|TWO_SIDED|95.0|-21.78|19.88|||ANCOVA|||||19.88|-21.78|0.928
74002467|NCT03110185|147553532|OTHER|Correlation||||||0.0761||||||Delirium Incidence. There were no multiple comparisons, but includes age as a regressor. a priori threshold was p \< 0.05.|Regression, Logistic|Generalized logistic regression for delirium incidence and total DMN fc with age as a regressor.||||||0.0761
74002468|NCT00600886|147553533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.942||||0.007|TWO_SIDED|95.0|1.19|3.168|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel adjusting for randomization stratification factor||Overall - All patients||3.168|1.190|0.007
74002469|NCT00600886|147553533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.337|||||TWO_SIDED|95.0|1.14|4.79||||||Post surgery - patients with prior surgery but no previous medical treatment for acromegaly||4.790|1.140|
74002470|NCT00600886|147553533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.654|||||TWO_SIDED|95.0|0.846|3.234||||||De novo - patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.||3.234|0.846|
74002471|NCT03075410|147553589|OTHER||Ratio|1.07|||||TWO_SIDED|90.0|0.87|1.34|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.|||1.34|0.87|
74037300|NCT01021852|147627782|SUPERIORITY_OR_OTHER||Difference in LS Means|-8.9|STANDARD_ERROR_OF_MEAN|4.61||0.055|TWO_SIDED|95.0|-18.0|0.2|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||0.2|-18.0|0.055
74037301|NCT01021852|147627782|SUPERIORITY_OR_OTHER||Difference in LS Means|-8.7|STANDARD_ERROR_OF_MEAN|4.61||0.06|TWO_SIDED|95.0|-17.8|0.4|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||0.4|-17.8|0.060
74039826|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.0034|TWO_SIDED|95.0|-0.77|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.77|0.0034
74002472|NCT03075410|147553590|OTHER||Ratio|0.94|||||TWO_SIDED|90.0|0.71|1.26|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-inf). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is use|||1.26|0.71|
74002473|NCT03075410|147553591|OTHER||Ratio|0.97|||||TWO_SIDED|90.0|0.76|1.23|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.|||1.23|0.76|
74002474|NCT03075410|147553592|OTHER||Ratio|0.89|||||TWO_SIDED|90.0|0.64|1.23|||||Fixed Effect Model has been used to assess Food Effect for the log transformed parameter t1/2 Treatment in the fed/fasted state is fitted as Fixed Effect.|||1.23|0.64|
74002475|NCT03075410|147553593|OTHER||Median Difference (Final Values)|0.75|||||TWO_SIDED|90.0|-0.5|2.5|||||Hodges-Lehmann estimation is used to calculate the 90% confidence interval.|||2.50|-0.50|
74002476|NCT03075410|147553597|OTHER||Slope|1.1|||||TWO_SIDED|90.0|1.09|1.1|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 5mg Day 1-14||1.10|1.09|
74002477|NCT03075410|147553597|OTHER||Slope|1.08|||||TWO_SIDED|90.0|1.07|1.08|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 15mg Day 1-14||1.08|1.07|
74002478|NCT03075410|147553598|OTHER||Slope|0.96|||||TWO_SIDED|90.0|0.82|1.1|||||A slope of 1 indicates the pharmacokinetics are dose proportional. A slope greater than 1 indicates the increase in PK is greater than proportional to dose.||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|1.10|0.82|
74002479|NCT03075410|147553599|OTHER||Slope|1.32|||||TWO_SIDED|90.0|1.24|1.39|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|||1.39|1.24|
74002480|NCT03075410|147553600|OTHER||Slope|0.96|||||TWO_SIDED|90.0|0.81|1.11|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|||1.11|0.81|
74002481|NCT03075410|147553601|OTHER||Slope|1.24|||||TWO_SIDED|90.0|1.15|1.33|||||Day 1.Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.33|1.15|
74002482|NCT03075410|147553601|OTHER||Slope|1.06|||||TWO_SIDED|90.0|0.9|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.22|0.90|
74002483|NCT03075410|147553602|OTHER||Slope|1.19|||||TWO_SIDED|90.0|0.92|1.46|||||Day 1. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.46|0.92|
74002484|NCT03075410|147553602|OTHER||Slope|1.06|||||TWO_SIDED|90.0|0.89|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.22|0.89|
74002485|NCT02112838|147553617|SUPERIORITY||Mean Difference (Final Values)|19.9||||0.97|TWO_SIDED|95.0|-910.6|950.5|||ANCOVA|||||950.5|-910.6|0.97
74002486|NCT02112838|147553617|SUPERIORITY||Mean Difference (Final Values)|-399.7||||0.4|TWO_SIDED|95.0|-1320.8|521.3|||ANCOVA|||||521.3|-1320.8|0.40
74002487|NCT03430206|147553634|OTHER|||||||0.206|||||||Regression, Negative Binomial|||||||0.206
74090907|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.8554|||TWO_SIDED|95.0|-3.5|3.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-3.5|
74090908|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|0.66|STANDARD_ERROR_OF_MEAN|1.8555|||TWO_SIDED|95.0|-3.0|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.3|-3.0|
74090909|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|1.8557|||TWO_SIDED|95.0|-4.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-4.8|
74090910|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.34|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-5.0|2.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-5.0|
73877903|NCT03084796|147295441|SUPERIORITY||Mean Difference (Final Values)|0.068||||0.037|TWO_SIDED|95.0|0.003|0.132|||Mixed Models Analysis|||"Comparison groups were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.132|0.003|0.037
74002488|NCT03430206|147553635|OTHER|||||||0.101|||||||Regression, Negative Binomial|||||||0.101
74037302|NCT01021852|147627782|SUPERIORITY_OR_OTHER||Difference in LS Means|-19.5|STANDARD_ERROR_OF_MEAN|4.62|<|0.001|TWO_SIDED|95.0|-28.6|-10.4|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-10.4|-28.6|<0.001
74037303|NCT01021852|147627782|SUPERIORITY_OR_OTHER||Difference in LS Means|-11.3|STANDARD_ERROR_OF_MEAN|4.63||0.015|TWO_SIDED|95.0|-20.5|-2.2|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-2.2|-20.5|0.015
74037304|NCT01021852|147627783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-9.5|12.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||12.2|-9.5|
74037305|NCT01021852|147627783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-10.3|11.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||11.2|-10.3|
74002489|NCT03430206|147553636|OTHER|||||||0.371|||||||Regression, Negative Binomial|||||||0.371
74002490|NCT03430206|147553638|OTHER|||||||0.601|||||||Regression, Negative Binomial|||||||0.601
74002491|NCT03430206|147553639|OTHER|||||||0.738|||||||Regression, Negative Binomial|||||||0.738
74002492|NCT03534284|147553653|SUPERIORITY|||||||0.6761||||||0.05 threshold for significance; no adjustment for multiple comparisons|Mixed Models Analysis|||Null hypothesis: average CBT-I=Trazodone=Placebo at week 7||||0.6761
74002493|NCT03534284|147553654|SUPERIORITY|||||||0.8375|||||||Mixed Models Analysis|||Null hypothesis: average CBT-I=Trazodone=Placebo at week 25||||0.8375
74037306|NCT01021852|147627783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||||TWO_SIDED|95.0|-4.2|18.3||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||18.3|-4.2|
74002494|NCT04737187|147553677|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.49|0.77||Stratified log-rank test, with a target p-value \< 0.025 for level of significance.|Stratified log-rank test||Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.|Overall Survival Median analysis: The primary estimand was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy).||0.77|0.49|< 0.001
74002495|NCT04737187|147553681|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.36|0.54||Stratified log-rank test, with a target p-value \< 0.025 for level of significance.|Stratified log-rank test||Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.|PFS Median analysis: A hierarchical testing method was used to control type I error and handle key secondary endpoint analysis. When the primary outcome measure significant testing was then performed sequentially on the key secondary outcome measure. statistically significant at 0.05 level.||0.54|0.36|< 0.001
74002496|NCT03756129|147553690|SUPERIORITY||Median Difference (Net)|-8.25||||0.0013|TWO_SIDED|80.0|-11.67|-4.83|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.16 mg/kg minus placebo. The MIJ821 treatment arms vs placebo are primary."||-4.83|-11.67|0.0013
74002497|NCT03756129|147553690|SUPERIORITY||Mean Difference (Net)|-5.71||||0.0196|TWO_SIDED|80.0|-9.22|-2.2|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.32 mg/kg minus placebo. The MIJ821 treatment arms vs placebo are primary."||-2.20|-9.22|0.0196
74002498|NCT03756129|147553691|SUPERIORITY||Mean Difference (Net)|-7.06||||0.013|TWO_SIDED|80.0|-11.06|-3.06|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.16 mg/kg minus placebo."||-3.06|-11.06|0.0130
74002499|NCT03756129|147553691|SUPERIORITY||Median Difference (Net)|-7.37||||0.0133|TWO_SIDED|80.0|-11.57|-3.18|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.32 mg/kg minus placebo."||-3.18|-11.57|0.0133
74002500|NCT03756129|147553692|SUPERIORITY||Mean Difference (Net)|-5.09||||0.1082|TWO_SIDED|80.0|-10.37|0.19|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.16 mg/kg weekly minus placebo."||0.19|-10.37|0.1082
74002501|NCT03756129|147553692|SUPERIORITY||Mean Difference (Net)|-5.42||||0.0993|TWO_SIDED|80.0|-10.83|-0.02|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.32 mg/kg weekly minus placebo."||-0.02|-10.83|0.0993
74002502|NCT03756129|147553692|SUPERIORITY||Mean Difference (Net)|-6.46||||0.0598|TWO_SIDED|80.0|-11.78|-1.15|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.16 mg/kg biweekly minus placebo."||-1.15|-11.78|0.0598
74002503|NCT03756129|147553692|SUPERIORITY||Mean Difference (Net)|-3.06||||0.2491|TWO_SIDED|80.0|-8.86|2.74|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.32 mg/kg biweekly minus placebo."||2.74|-8.86|0.2491
74002504|NCT04363801|147553767|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.9676|TWO_SIDED|95.0|0.98|2.05|||Log Rank|||||2.05|0.98|0.9676
74037307|NCT01021852|147627783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|||||TWO_SIDED|95.0|-2.3|20.4||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||20.4|-2.3|
74037308|NCT01021852|147627784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||||TWO_SIDED|95.0|-1.0|10.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||10.2|-1.0|
74037309|NCT01021852|147627784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.6|4.8||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||4.8|-3.6|
74037310|NCT01021852|147627784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-2.7|6.6||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||6.6|-2.7|
74002505|NCT04363801|147553784|SUPERIORITY||Risk Difference (RD)|2.4||||0.3799|TWO_SIDED|95.0|-12.2|16.9|||Cochran-Mantel-Haenszel|||||16.9|-12.2|0.3799
74002506|NCT04363801|147553787|SUPERIORITY|||||||0.8679|||||||Log Rank|Stratified Log-rank Test||||||0.8679
74002507|NCT04363801|147553787|SUPERIORITY|||||||0.9676|||||||Log Rank|Stratified Log-rank Test||||||0.9676
74002508|NCT04363801|147553787|SUPERIORITY||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.74|3.05||||||||3.05|0.74|
74002509|NCT04363801|147553787|SUPERIORITY||Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.98|2.05||||||||2.05|0.98|
74002510|NCT04363801|147553788|SUPERIORITY||Risk Difference (RD)|8.4||||0.2649|TWO_SIDED|95.0|-18.4|33.6|||Mantel Haenszel||Common Risk Difference and 95% CI: estimated by stratified Newcombe method, weighted by minimum risk|||33.6|-18.4|0.2649
74002511|NCT04363801|147553788|SUPERIORITY||Risk Difference (RD)|2.4||||0.379|TWO_SIDED|95.0|-12.2|16.9|||Mantel Haenszel|||||16.9|-12.2|0.379
74002512|NCT06336603|147553795|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< .001
74002513|NCT06336603|147553796|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< .001
74002514|NCT06336603|147553797|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< .001
74002515|NCT04776148|147553804|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis (Yes/No).|Hazard Ratio (HR)|0.69||||0.0003|TWO_SIDED|95.0|0.56|0.85||One-sided p-value based on log-rank test stratified by presence of liver metastasis|Log Rank|||||0.85|0.56|0.0003
74037311|NCT01021852|147627784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-4.5|2.3||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||2.3|-4.5|
74037312|NCT03491553|147627788|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037313|NCT03491553|147627788|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037314|NCT03491553|147627788|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037315|NCT03491553|147627788|OTHER||Percentage Difference|10.0|||||TWO_SIDED|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.|||47.1|-47.2|
74037316|NCT03491553|147627789|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037317|NCT03491553|147627789|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
73877904|NCT03084796|147295441|SUPERIORITY||Mean Difference (Final Values)|0.116|||<|0.001|TWO_SIDED|95.0|0.051|0.181|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.181|0.051|<0.001
74002516|NCT04776148|147553805|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.15||||0.7421|TWO_SIDED|85.0|0.75|1.77||One-sided p-value based on log-rank test.|Log Rank|||||1.77|0.75|0.7421
74002517|NCT04776148|147553806|OTHER||Difference in Percentage vs. SOC|8.7|||<|0.0001|TWO_SIDED|95.0|4.7|13.5|||Chi-squared||Based on Miettinen \& Nurminen method stratified by presence of liver metastasis|||13.5|4.7|<0.0001
74002518|NCT04776148|147553807|OTHER||Difference in Percentage vs. SOC|3.3||||0.2456|TWO_SIDED|95.0|-7.7|14.3|||Chi-squared||Based on Miettinen \& Nurminen method.|||14.3|-7.7|0.2456
74002519|NCT04776148|147553814|OTHER||Difference in least squares means|2.71||||0.1553|TWO_SIDED|95.0|-1.03|6.46||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||6.46|-1.03|0.1553
74002520|NCT04776148|147553815|OTHER||Difference in LS means|1.16||||0.4967|TWO_SIDED|95.0|-2.19|4.51||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||4.51|-2.19|0.4967
74002521|NCT04776148|147553816|OTHER||Difference in LS means|3.36||||0.2271|TWO_SIDED|95.0|-2.1|8.82||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||8.82|-2.10|0.2271
74002522|NCT04776148|147553817|OTHER||Difference in LS means|-5.46||||0.0264|TWO_SIDED|95.0|-10.27|-0.65||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||-0.65|-10.27|0.0264
74002523|NCT04776148|147553818|OTHER||Hazard Ratio (HR)|0.91||||0.4338|TWO_SIDED|95.0|0.73|1.14|||Regression, Cox|Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).||||1.14|0.73|0.4338
74002524|NCT04776148|147553819|OTHER||Hazard Ratio (HR)|1.1||||0.4316|TWO_SIDED|95.0|0.87|1.38||Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|Regression, Cox|||||1.38|0.87|0.4316
74002525|NCT04776148|147553820|OTHER||Hazard Ratio (HR)|1.06||||0.5587|TWO_SIDED|95.0|0.85|1.32|||Regression, Cox|Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).||||1.32|0.85|0.5587
74002526|NCT04776148|147553821|OTHER||Hazard Ratio (HR)|0.95||||0.6794|TWO_SIDED|95.0|0.73|1.23||Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|Regression, Cox|||||1.23|0.73|0.6794
74002527|NCT04776148|147553822|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0379|TWO_SIDED|95.0|0.68|1.02|||Log Rank|One-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|HR=Lenvatinib + pembrolizumab vs. SOC treatment|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis (Yes/No).||1.02|0.68|0.0379
74002528|NCT04776148|147553823|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3574|TWO_SIDED|95.0|0.6|1.42|||Log Rank|One-sided p-value based on log-rank test.|HR=Lenvatinib + pembrolizumab vs. SOC treatment|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.||1.42|0.60|0.3574
74002529|NCT02563522|147553824|OTHER||Mean Difference (Final Values)|18.7||||0.3455|TWO_SIDED|95.0|-12.37|45.81|||Fisher Exact|No imputation was performed for subjects with missing response data||The statistical hypotheses were H0: Pt = Pc versus Ha: Pt ≠ Pc, where Pt and Pc are the proportions of subjects with a confirmed target would closure by the 4-month follow-up for Active (Engensis) and Control (Placebo) groups, respectively. The hypothesis testing was a two-sided alpha of 0.05||45.81|-12.37|0.3455
74002530|NCT04874415|147553828|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.05|TWO_SIDED|95.0|-6.2|5.3|||Regression, Linear|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||5.3|-6.2|<0.05
74002531|NCT04874415|147553828|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|-2.4|||<|0.05|TWO_SIDED|95.0|-9.4|4.6|||Regression, Linear||Fixed step count is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||4.6|-9.4|<0.05
74002532|NCT04874415|147553828|SUPERIORITY||Mean Difference (Final Values)|-4.0|||<|0.05|TWO_SIDED|95.0|-11.0|3.1|||Regression, Linear|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Loss framed incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||3.1|-11|<0.05
74002533|NCT04874415|147553828|SUPERIORITY||Mean Difference (Final Values)|4.4|||<|0.05|TWO_SIDED|95.0|-1.0|9.8|||Regression, Linear|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Daily step count goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||9.8|-1.0|<0.05
74002534|NCT04874415|147553829|SUPERIORITY||Mean Difference (Final Values)|-686.0|||<|0.05|TWO_SIDED|95.0|-2997.0|1626.0|||Regression, Linear|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||1626|-2997|<0.05
74002535|NCT04874415|147553829|SUPERIORITY||Mean Difference (Final Values)|-2340.0|||<|0.05|TWO_SIDED|95.0|-4794.0|115.0|||Regression, Linear|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Fixed step count goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||115|-4794|<0.05
74002536|NCT04874415|147553829|SUPERIORITY||Mean Difference (Final Values)|-1293.0|||<|0.05|TWO_SIDED|95.0|-3477.0|890.0|||Regression, Linear|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|||Loss framed incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|890|-3477|<0.05
74002537|NCT04874415|147553829|SUPERIORITY||Mean Difference (Final Values)|-135.0|||<|0.05|TWO_SIDED|95.0|-2424.0|2153.0||Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Regression, Linear||Daily step count goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||2153|-2424|<0.05
74002538|NCT04874415|147553830|SUPERIORITY|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Mean Difference (Final Values)|-0.006||||0.05|TWO_SIDED|95.0|-0.05|0.04|||Regression, Linear||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.04|-0.05|0.05
74002539|NCT04874415|147553830|SUPERIORITY||Mean Difference (Net)|-0.03||||0.05|TWO_SIDED|95.0|-0.07|0.02|||Regression, Linear||Fixed step count goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.||0.02|-0.07|0.05
74002540|NCT04874415|147553830|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.05|TWO_SIDED|95.0|-0.02|0.06||Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Regression, Linear||||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|0.06|-0.02|0.05
74002541|NCT04874415|147553830|SUPERIORITY||Mean Difference (Final Values)|-0.0006||||0.05|TWO_SIDED|95.0|-0.04|0.04|||Regression, Linear|Main effects of each intervention factor were estimated using linear regression including all prespecified two-way interactions.|Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.04|-0.04|0.05
74002542|NCT04874415|147553831|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.05|TWO_SIDED|95.0|-10.3|10.3|||Regression, Linear|Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||10.3|-10.3|0.05
74002543|NCT04874415|147553831|SUPERIORITY||Mean Difference (Final Values)|0.00001||||0.05|TWO_SIDED|95.0|-0.03|0.03|||Regression, Linear|Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|0.03|-0.03|0.05
74002544|NCT04874415|147553831|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.05|TWO_SIDED|95.0|-12.7|12.7||Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Regression, Linear||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||12.7|-12.7|0.05
74002545|NCT04874415|147553831|SUPERIORITY||Mean Difference (Final Values)|-0.00002||||0.05|TWO_SIDED|95.0|-0.03|0.03||Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Regression, Linear||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.03|-0.03|0.05
74002546|NCT04874415|147553832|SUPERIORITY||Mean Difference (Final Values)|0.00003||||0.05|TWO_SIDED|95.0|-2311.0|2311.0||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||2311|-2311|0.05
74002547|NCT04874415|147553832|SUPERIORITY||Mean Difference (Final Values)|0.0000004||||0.05|TWO_SIDED|95.0|-27.9|27.9||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||27.9|-27.9|0.05
74002548|NCT04874415|147553832|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.05|TWO_SIDED|95.0|-6.9|6.8||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||6.8|-6.9|0.05
74002549|NCT04874415|147553832|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.05|TWO_SIDED|95.0|-126.0|125.0||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||125|-126|0.05
74037318|NCT03491553|147627789|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037319|NCT03491553|147627789|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037320|NCT03491553|147627790|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037321|NCT03491553|147627790|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037322|NCT03491553|147627790|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037323|NCT03491553|147627790|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037324|NCT03491553|147627791|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037325|NCT03491553|147627791|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037326|NCT03491553|147627791|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037327|NCT03491553|147627791|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
73877905|NCT03084796|147295441|SUPERIORITY||Mean Difference (Final Values)|0.151|||<|0.001|TWO_SIDED|95.0|0.086|0.216|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.216|0.086|<0.001
73877906|NCT03084796|147295441|SUPERIORITY||Mean Difference (Final Values)|0.145|||<|0.001|TWO_SIDED|95.0|0.081|0.209|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.209|0.081|<0.001
74002550|NCT04874415|147553833|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.05|TWO_SIDED|95.0|-3.9|3.9||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||3.9|-3.9|0.05
74002551|NCT04874415|147553833|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.05|TWO_SIDED|95.0|-2.6|2.6||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||2.6|-2.6|0.05
74090911|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.84|STANDARD_ERROR_OF_MEAN|1.8566|||TWO_SIDED|95.0|-4.5|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-4.5|
73877907|NCT03084796|147295441|SUPERIORITY||Mean Difference (Final Values)|0.211|||<|0.001|TWO_SIDED|95.0|0.159|0.263|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.263|0.159|<0.001
74002552|NCT04874415|147553833|SUPERIORITY||Mean Difference (Final Values)|-0.00001||||0.05|TWO_SIDED|95.0|-0.02|0.02||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.02|-0.02|0.05
74037328|NCT03491553|147627792|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037329|NCT03491553|147627792|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
73877908|NCT03084796|147295441|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.066|TWO_SIDED|95.0|-0.003|0.1|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.100|-0.003|0.066
74002553|NCT04874415|147553833|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.05|TWO_SIDED|95.0|-22.8|22.8||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Daily Step Count goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||22.8|-22.8|0.05
74002554|NCT04874415|147553834|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.05|TWO_SIDED|95.0|-38.3|38.2||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||38.2|-38.3|0.05
74002555|NCT04874415|147553834|SUPERIORITY||Mean Difference (Final Values)|0.0001||||0.05|TWO_SIDED|95.0|-0.3|0.3||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.3|-0.3|0.05
74037330|NCT03491553|147627792|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
74037331|NCT03491553|147627792|OTHER||Percentage Difference|10.0|||||TWO_SIDED|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.|||47.1|-47.2|
74037332|NCT00906074|147627809|SUPERIORITY_OR_OTHER|||||||0.881|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Neoplasm||||0.881
74037333|NCT00906074|147627809|SUPERIORITY_OR_OTHER|||||||0.517|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Tobacco use||||0.517
74037334|NCT00906074|147627809|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||BMI(kg/mˆ2)\>30||||0.053
74037335|NCT00906074|147627809|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Diabetes mellitus||||0.289
74037336|NCT00906074|147627809|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Immunosuppression/Corticosteroids||||1.000
74002556|NCT04874415|147553834|SUPERIORITY||Mean Difference (Final Values)|-0.0006||||0.05|TWO_SIDED|95.0|-0.8|0.8||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.8|-0.8|0.05
74002557|NCT04874415|147553834|SUPERIORITY||Mean Difference (Final Values)|-0.0001||||0.05|TWO_SIDED|95.0|-0.4|0.4||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.4|-0.4|0.05
74002558|NCT04874415|147553835|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.05|TWO_SIDED|95.0|-31.4|31.5||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||31.5|-31.4|0.05
74002559|NCT04874415|147553835|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.05|TWO_SIDED|95.0|-44.3|44.5||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||44.5|-44.3|0.05
74037337|NCT00906074|147627809|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Anemia (Hb\<9gr/dL)||||0.169
74002560|NCT04874415|147553835|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.05|TWO_SIDED|95.0|-2.7|14.2||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||14.2|-2.7|0.05
74002561|NCT04874415|147553835|SUPERIORITY||Mean Difference (Final Values)|-5.4||||0.05|TWO_SIDED|95.0|-13.3|2.4||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||2.4|-13.3|0.05
74002562|NCT04874415|147553836|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.05|TWO_SIDED|95.0|-3.1|3.1||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||3.1|-3.1|0.05
74037338|NCT00906074|147627809|SUPERIORITY_OR_OTHER|||||||0.637|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Malnutrition (hypoalbuminemia)||||0.637
74037339|NCT00906074|147627810|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||1.000
74037340|NCT00906074|147627811|SUPERIORITY_OR_OTHER|||||||0.873|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||0.873
74037341|NCT00906074|147627816|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||0.156
74037342|NCT00906074|147627817|SUPERIORITY_OR_OTHER|||||||0.444|TWO_SIDED||||||Fisher Exact|||||||0.444
74037343|NCT02128763|147627823|SUPERIORITY|||||||0.4|TWO_SIDED|95.0||||P value refers to difference between group on change in overall OSDI score (Row 1).|Regression, Linear|||||||0.40
73877909|NCT03084796|147295441|SUPERIORITY||Mean Difference (Final Values)|0.083||||0.002|TWO_SIDED|95.0|0.031|0.135|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.135|0.031|0.002
74002563|NCT04874415|147553836|SUPERIORITY||Mean Difference (Final Values)|-0.0003||||0.05|TWO_SIDED|95.0|-2.3|2.3||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||2.3|-2.3|0.05
74002564|NCT04874415|147553836|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.05|TWO_SIDED|95.0|-3.4|3.4||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||3.4|-3.4|0.05
74002565|NCT04874415|147553836|SUPERIORITY||Mean Difference (Final Values)|-0.0005||||0.05|TWO_SIDED|95.0|-0.5|0.5||Main effects of each intervention factor were estimated using generalized linear models with log link, including all prespecified two-way interactions.|Regression, Linear||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.5|-0.5|0.05
74002566|NCT04874415|147553837|SUPERIORITY||Mean Difference (Final Values)|0.00000001||||0.05|TWO_SIDED|95.0|-0.00002|0.00002||Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Regression, Linear||Once daily text message is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.00002|-0.00002|0.05
74002567|NCT04874415|147553837|SUPERIORITY||Mean Difference (Final Values)|-0.00002||||0.05|TWO_SIDED|95.0|-0.03|0.03||Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Regression, Linear||Fixed Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.03|-0.03|0.05
74002568|NCT04874415|147553837|SUPERIORITY||Mean Difference (Final Values)|0.00002||||0.05|TWO_SIDED|95.0|-0.03|0.03||Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).)|Regression, Linear||Loss Framed Incentive is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.03|-0.03|0.05
74002569|NCT04874415|147553837|SUPERIORITY||Mean Difference (Final Values)|-0.000003||||0.05|TWO_SIDED|95.0|-0.004|0.004||Main effects were estimated using generalized linear models with log link. No interactions were included (failure to converge).|Regression, Linear||Daily Step Count Goal is reference group. Least-squares means (marginal means) were calculated, averaging across levels of the other factors with equal weighting (asbalanced).|||0.004|-0.004|0.05
74002570|NCT04018092|147553914|SUPERIORITY|||||||0.573||||||Only 2 values, thus not necessary to adjust.|Regression, Linear|The independent variable = intervention (active, sham); Covariates=baseline scores, site (Florida, Arizona), age (yrs), sex (m,f), and education (yrs)||linear regression was used to analyze pre-post intervention changes in the active vs sham group. Covariates in regression were baseline cognitive performance, site (University of Florida, University of Arizona), age (yrs), sex (F, M) and education (years)||||0.573
74002571|NCT04018092|147553915|SUPERIORITY|||||||0.043||||||Default Mode Network Analysis: Regression was performed using permutation tests with 5000 iterations for significance and to address multiple comparisons.|Regression, Linear|Covariates: Baseline network segregation values, Age, Sex, Education years, study site Baseline white matter hyperintensity volume. DOF = (1, 135)||||||0.043
74002572|NCT04018092|147553915|SUPERIORITY|||||||0.285||||||Frontoparietal Control Network Analysis: Regression was performed using permutation tests with 5000 iterations for significance and to address multiple comparisons.|Regression, Linear|Covariates: Baseline network segregation values, age, sex, education years, study site and baseline white matter hyperintensity volume. DOF = (1, 135)||||||0.285
74002573|NCT05218499|147553916|OTHER||Hazard Ratio (HR)|0.79||||0.0956|TWO_SIDED|95.0|0.6|1.06|||Regression, Cox||A hazard ratio value below 1 favors brigimadlin.|The primary estimator for the hazard ratio is the median unbiased estimator. The confidence interval (CI) for the hazard ratio is calculated as a repeated CI. The p-value is obtained using a weighted inverse normal method combining one-sided p-values from two stages.||1.06|0.60|0.0956
74002574|NCT05218499|147553917|OTHER||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|1.52|5.67|||||An odds ratio value greater than 1 favors brigimadlin.|The primary estimator and CI for the odds ratio is by Cochran-Mantel-Haenszel.||5.67|1.52|
74002575|NCT05218499|147553919|OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.81|2.82|||||An odds ratio value greater than 1 favors brigimadlin.|Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate.||2.82|0.81|
74002576|NCT05218499|147553919|OTHER||Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.48|4.84|||||An odds ratio value greater than 1 favors brigimadlin.|Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate. Exact 95% confidence interval (CI) by Clopper and Pearson.||4.84|1.48|
74002577|NCT04055090|147553922|OTHER||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.438||0.046|TWO_SIDED|95.0|-1.76|-0.02|||Mixed Models Analysis|Mixed-effects Model for Repeated Measures (MMRM) with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects|Mixed-effects Model for Repeated Measures with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects. The Baseline average 24-hour pain score was included as a covariate.|||-0.02|-1.76|0.0460
74002578|NCT04055090|147553924|OTHER|||||||0.219|||||||Cochran-Mantel-Haenszel|||||||0.2190
73877910|NCT03084796|147295441|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.003|TWO_SIDED|95.0|0.026|0.128|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.128|0.026|0.003
74002579|NCT04055090|147553925|OTHER||Least-Squares Mean Difference|-1.48||||0.0155|TWO_SIDED|95.0|-2.67|-0.29|||Mixed Models Analysis||Mixed-effects Model for Repeated Measures (MMRM) with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects. Baseline average 24-hour pain score is included as a covariate.|||-0.29|-2.67|0.0155
74002580|NCT03952585|147553926|NON_INFERIORITY|Estimated 9-month PFS = 96.5% and lower acceptable threshold = 91.8%, resulting in a non-inferiority margin of 4.7%. H0: HR = 2.4; alternative hypothesis (HA): HR=1.0. One-sided type I error rate of 10% (20% after Bonferroni adjustment for each experimental arm comparison), 80% power, 24 months of accrual with 1 year of additional follow-up, and 1% increasing yearly rate of drop-out up to 3%, a log rank test requires 22 events from 266 patients per comparison resulting in 133 patients per arm.|Hazard Ratio (HR)|7.42|||||ONE_SIDED|90.0||19.46|||||Reference level = Arm 1|The null hypothesis (H0) for each comparison in phase II will be rejected if the 90% upper confidence of the hazard ratio (HR) (experimental arm / standard arm) is less than HR=2.4.||19.46||
74002581|NCT03952585|147553926|NON_INFERIORITY|Estimated 9-month PFS = 96.5% and lower acceptable threshold = 91.8%, resulting in a non-inferiority margin of 4.7%. H0: HR = 2.4; alternative hypothesis (HA): HR=1.0. One-sided type I error rate of 10% (20% after Bonferroni adjustment for each experimental arm comparison), 80% power, 24 months of accrual with 1 year of additional follow-up, and 1% increasing yearly rate of drop-out up to 3%, a log rank test requires 22 events from 266 patients per comparison resulting in 133 patients per arm.|Hazard Ratio (HR)|5.55|||||ONE_SIDED|90.0||14.85|||||Reference level = Arm 1|The null hypothesis (H0) for each comparison in phase II will be rejected if the 90% upper confidence of the hazard ratio (HR) (experimental arm / standard arm) is less than HR=2.4.||14.85||
74002582|NCT03952585|147553929|SUPERIORITY||Hazard Ratio (HR)|20.56|||||TWO_SIDED|95.0|1.05|403.31|||||Cause-specific; reference level = Arm 1|||403.31|1.05|
74002583|NCT03952585|147553929|SUPERIORITY||Hazard Ratio (HR)|12.87|||||TWO_SIDED|95.0|0.58|287.93|||||Reference level = Arm 1|||287.93|0.58|
74002584|NCT03952585|147553930|SUPERIORITY||Cox Proportional Hazard|1.78|||||TWO_SIDED|95.0|0.34|9.46|||||Cause-specific; reference level = Arm 1|||9.46|0.34|
74002585|NCT03952585|147553930|SUPERIORITY||Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.24|8.45|||||Cause-specific; reference level = Arm 1|||8.45|0.24|
74002586|NCT03952585|147553931|SUPERIORITY||Hazard Ratio (HR)|5.58|||||TWO_SIDED|95.0|0.67|46.41|||||Reference level = Arm 1|||46.41|0.67|
74002587|NCT03952585|147553931|SUPERIORITY||Hazard Ratio (HR)|4.87|||||TWO_SIDED|95.0|0.57|41.74|||||Reference level = Arm 1|||41.74|0.57|
74002588|NCT04572841|147553943|SUPERIORITY||Least Square Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.39|2.02||||||Analysis was performed for change from baseline using a mixed model for repeated measures with visit, intervention group (SAR441344 and Placebo), and visit by intervention group interaction as fixed categorical effects, and participant specific baseline ESSDAI as continuous covariate.||2.02|-1.39|
74002589|NCT01205152|147553973|OTHER|||||||0.002||||||Two-sided with p-value threshold \<0.05 for statistical significance.|Wilcoxon signed-rank test|||Change is relative to Baseline in Study ENB-002-08 (NCT00744042). The RGI-C score represents evaluation of skeletal X-rays at each post-treatment study timepoint compared with pre-treatment X-rays from Study ENB-002-08 using an ordinal scale. Therefore, an RGI-C score is not applicable for radiographs obtained at Baseline.||||0.0020
74002590|NCT04494256|147554005|SUPERIORITY||Least square (LS) mean difference|-0.1|STANDARD_ERROR_OF_MEAN|7.84|=|0.9924|TWO_SIDED|95.0|-15.47|15.32||ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.|ANCOVA|||||15.32|-15.47|=0.9924
74002591|NCT04494256|147554006|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|2.01|=|0.9203|TWO_SIDED|95.0|-4.14|3.74||ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.|ANCOVA|||||3.74|-4.14|=0.9203
74002592|NCT04494256|147554007|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12|=|0.1069|TWO_SIDED|95.0|-0.41|0.04||ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.|ANCOVA|||||0.04|-0.41|=0.1069
74002593|NCT04494256|147554008|SUPERIORITY||Hazard Ratio (HR)|4.29|||=|0.1003|TWO_SIDED|95.0|0.433|42.587|||Log Rank|Log rank test stratified by median baseline plasma NfL||||42.587|0.433|=0.1003
74002594|NCT04494256|147554009|SUPERIORITY||||||=|0.1143|||||||Kaplan-Meier product limit method|||||||=0.1143
74002595|NCT02513303|147554021|SUPERIORITY|||||||0.2942|||||||Regression, Logistic|||||||0.2942
74002596|NCT04689828|147554041|SUPERIORITY||Hazard Ratio (HR)|0.41||||1e-08|TWO_SIDED|95.0|0.29|0.56|||Log Rank|Stratified||||0.56|0.29|0.00000001
74002597|NCT04689828|147554042|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2|TWO_SIDED|95.0|0.72|1.14|||stratified Cox PH model|||||1.14|0.72|0.20
74002598|NCT03464097|147554104|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0539|TWO_SIDED|95.0|0.99|2.55|||Cochran-Mantel-Haenszel|||||2.55|0.99|0.0539
74002599|NCT03464097|147554105|SUPERIORITY||Odds Ratio (OR)|1.51||||0.1503|TWO_SIDED|95.0|0.86|2.65|||Cochran-Mantel-Haenszel|||||2.65|0.86|0.1503
74002600|NCT03464097|147554106|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1121|TWO_SIDED|95.0|0.92|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.92|0.1121
74002601|NCT03464097|147554107|SUPERIORITY||Odds Ratio (OR)|1.46||||0.1163|TWO_SIDED|95.0|0.91|2.35|||Cochran-Mantel-Haenszel|||||2.35|0.91|0.1163
74002602|NCT03464097|147554108|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0561|TWO_SIDED|95.0|0.98|3.2|||Cochran-Mantel-Haenszel|||||3.20|0.98|0.0561
74002603|NCT03464097|147554109|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5061|TWO_SIDED|95.0|0.6|2.86|||Cochran-Mantel-Haenszel|||||2.86|0.60|0.5061
74002604|NCT03464097|147554110|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1179|TWO_SIDED|95.0|0.82|5.44|||Cochran-Mantel-Haenszel|||||5.44|0.82|0.1179
74002605|NCT03464097|147554111|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0769|TWO_SIDED|95.0|0.94|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.94|0.0769
74002606|NCT03464097|147554112|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0623|TWO_SIDED|95.0|0.92|7.98|||Cochran-Mantel-Haenszel|||||7.98|0.92|0.0623
74002607|NCT03464097|147554113|SUPERIORITY||Odds Ratio (OR)|1.63||||0.1162|TWO_SIDED|95.0|0.89|3.0|||Cochran-Mantel-Haenszel|||||3.00|0.89|0.1162
74002608|NCT03464097|147554114|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2143|TWO_SIDED|95.0|0.85|2.11|||Cochran-Mantel-Haenszel|||||2.11|0.85|0.2143
74002609|NCT03464097|147554115|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0663|TWO_SIDED|95.0|0.97|2.57|||Cochran-Mantel-Haenszel|||||2.57|0.97|0.0663
74002610|NCT03464097|147554116|SUPERIORITY||Odds Ratio (OR)|3.81||||0.0774|TWO_SIDED|95.0|0.78|18.64|||Cochran-Mantel-Haenszel|||||18.64|0.78|0.0774
74002611|NCT03464097|147554118|SUPERIORITY||Odds Ratio (OR)|1.88||||0.0308|TWO_SIDED|95.0|1.06|3.33|||Cochran-Mantel-Haenszel|||||3.33|1.06|0.0308
74002612|NCT03464097|147554119|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8745|TWO_SIDED|95.0|0.57|1.95|||Cochran-Mantel-Haenszel|||||1.95|0.57|0.8745
74002613|NCT03464097|147554120|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0361|TWO_SIDED|95.0|1.04|3.78|||Cochran-Mantel-Haenszel|||||3.78|1.04|0.0361
74002614|NCT03035201|147554121|OTHER|two-tailed test of the null hypothesis of no differences between groups.|Mean from linear contrast|0.03|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|-0.02|0.08||Not adjusted|Mixed Models Analysis||Marginal effect of cocoa flavonal versus cocoa placebo based on the mean difference between linear contrasts.|Marginal comparisons from a repeated measures model using a linear contrast to estimate the mean differences between baseline versus average values across follow-up.|Wald test of a linear contrast from the mixed effects analysis....see protocol.|0.08|-0.02|<0.05
74002615|NCT03035201|147554122|EQUIVALENCE|two-tailed test of the null hypothesis of no differences between groups.|Mean difference of linear contrasts|0.07|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|0.02|0.12||Not adjusted|Wald test||Marginal effects of multivitamin versus multivitamin placebo|Marginal comparisons from a repeated measures model using a linear contrast to estimate the mean differences between baseline versus average values across follow-up.|Wald test of a linear contrast from the mixed effects analysis....see protocol|0.12|0.02|<0.05
74002616|NCT03035201|147554123|EQUIVALENCE|Proportional hazards regression -- unadjusted two-sided test|Hazard Ratio (HR)|0.76||||0.15|TWO_SIDED|95.0|0.52|1.11||Not adjusted|Regression, Cox||Comparison group is placebo|||1.11|0.52|0.15
74002617|NCT03035201|147554124|EQUIVALENCE|Unadjusted 2-sided test|Cox Proportional Hazard|0.91||||0.62|TWO_SIDED|95.0|0.63|1.32||Unadjusted|Regression, Cox||Comparison group is placebo.|||1.32|0.63|0.62
74002618|NCT03035201|147554125|EQUIVALENCE|Cocoa Flavonal minus Placebo|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.24|TWO_SIDED|95.0|-0.02|0.08||Unadjusted|Mixed Models Analysis|Wald test comparing linear contrasts|Cocoa Flavonal minus placebo|||0.08|-0.02|0.24
74002619|NCT03035201|147554126|EQUIVALENCE|two-sided|Median Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|95.0|-0.04|0.09||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts: cocoa flavonal minus placebo|Cocoa flavonal minus placebo|Unadjusted 2-tailed test||0.09|-0.04|0.41
74002620|NCT03035201|147554127|EQUIVALENCE|2 sided test, multivitamin minus placebo|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.02|TWO_SIDED|95.0|0.01|0.11||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts|Multivitamin minus placebo|2-sided test, unadjusted||0.11|0.01|0.02
74002621|NCT03035201|147554128|EQUIVALENCE|2-sided, unadjusted|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.04|TWO_SIDED|95.0|0.002|0.126||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts|Multivitamin minus placebo|Multivitamin minus placebo||0.126|0.002|0.04
74002622|NCT04576455|147554148|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1757|TWO_SIDED|95.0|0.6|1.1|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|||1.10|0.60|0.1757
74002623|NCT04576455|147554149|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.3446|TWO_SIDED|95.0|0.85|1.6|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|||1.60|0.85|0.3446
74002624|NCT04576455|147554150|SUPERIORITY||Odds Ratio (OR)|1.87||||0.1126|TWO_SIDED|95.0|0.86|4.07|||Cochran-Mantel-Haenszel||Giredestrant vs. PCET|||4.07|0.86|0.1126
74002625|NCT04576455|147554150|SUPERIORITY||Difference in Objective Response Rates|5.35|||||TWO_SIDED|95.0|-1.97|12.78|||||Giredestrant vs. PCET|||12.78|-1.97|
74002626|NCT04576455|147554152|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0289|TWO_SIDED|95.0|1.06|3.04|||Cochran-Mantel-Haenszel||Giredestrant vs. PCET|||3.04|1.06|0.0289
74002627|NCT04576455|147554152|SUPERIORITY||Difference in Clinical Benefit Rates|10.74|||||TWO_SIDED|95.0|0.33|20.86|||||Giredestrant vs. PCET|||20.86|0.33|
74037344|NCT02128763|147627824|SUPERIORITY|||||||0.09|TWO_SIDED|95.0|||||Regression, Linear|||||||0.09
74002628|NCT04576455|147554153|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.061|TWO_SIDED|95.0|0.35|1.03|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|This statistical analysis is done for PFS by ESR1 mutation detected at baseline||1.03|0.35|0.0610
74002629|NCT04576455|147554153|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5947|TWO_SIDED|95.0|0.54|1.42|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|This statistical analysis is done for PFS by ESR1 Mutation not detected at baseline||1.42|0.54|0.5947
74002630|NCT04576455|147554154|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.58|1.4|||||Giredestrant vs. PCET|||1.40|0.58|
74002631|NCT04576455|147554155|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.49|1.12|||||Giredestrant vs. PCET|||1.12|0.49|
74002632|NCT04576455|147554156|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.35|||||Giredestrant vs. PCET|||1.35|0.53|
74002633|NCT04576455|147554157|OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.72|1.69|||||Giredestrant vs. PCET|||1.69|0.72|
74002634|NCT04576455|147554158|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.47|1.18|||||Giredestrant vs. PCET|||1.18|0.47|
74037345|NCT02128763|147627825|SUPERIORITY|||||||0.77|TWO_SIDED|95.0|||||Regression, Linear|Pos hoc application of the Benjamini-Hochberg adjustment||||||0.77
74037346|NCT02128763|147627826|SUPERIORITY|||||||0.95|TWO_SIDED|95.0|||||Regression, Linear|||||||0.95
74037347|NCT02128763|147627827|SUPERIORITY|||||||0.051|TWO_SIDED|95.0|||||Regression, Linear|||||||0.051
74037348|NCT02128763|147627828|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
73877911|NCT03084796|147295441|SUPERIORITY||Mean Difference (Final Values)|0.035||||0.189|TWO_SIDED|95.0|-0.017|0.087|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.087|-0.017|0.189
74002635|NCT02186847|147554164|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.7563|TWO_SIDED|95.0|0.77|1.73|||Log Rank|One-sided significance level = 0.10|Reference level = Chemoradiation|The study was powered to detect an improvement of the 1-year progression-free survival rate from 50% (no metformin) to 65% (metformin) or equivalently a hazard ratio (HR) of 0.622, at one-sided type 1 error of 0.1 and 85% power with at least 102 progression-free survival events.||1.73|0.77|0.7563
74002636|NCT02186847|147554165|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.891|TWO_SIDED|95.0|0.64|1.68|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation|||1.68|0.64|0.8910
74002637|NCT02186847|147554166|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.4075|TWO_SIDED|95.0|0.71|2.34|||Log Rank|Two-side significance level = 0.05|Reference level = Chemoradiation|||2.34|0.71|0.4075
74002638|NCT02186847|147554167|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.4075|TWO_SIDED|95.0|0.71|2.34|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation|||2.34|0.71|0.4075
74002639|NCT02186847|147554168|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6266|TWO_SIDED|95.0|0.47|1.8|||Chi-squared|Two-sided significance level = 0.05|Reference level = Chemoradiation|||1.80|0.47|0.6266
74002640|NCT03319849|147554169|SUPERIORITY||Median Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.0206||0.0186|TWO_SIDED|95.0|-0.089|-0.0082|||Mixed Models Analysis|||||-0.0082|-0.0890|0.0186
74002641|NCT02254278|147554172|SUPERIORITY|||||||0.04|||||||binomial|One-sided significance level=0.10||Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year progression-free survival (PFS) rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.||||0.04
74002642|NCT02254278|147554172|SUPERIORITY|||||||0.23|||||||bionmial|One-sided significance level = 0.10||Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year PFS rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.||||0.23
74002643|NCT02254278|147554173|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.02|TWO_SIDED|95.0|0.17|0.9|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT 5 weeks|||0.90|0.17|0.02
74002644|NCT02254278|147554174|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.58|TWO_SIDED|95.0|0.4|5.08|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT 5 weeks|||5.08|0.4|0.58
74002645|NCT02254278|147554175|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.93|TWO_SIDED|95.0|0.31|2.95||Two-side significance level = 0.05|Log Rank||Reference level = IMRT 5 weeks|||2.95|0.31|0.93
74037349|NCT02128763|147627829|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
74037350|NCT02128763|147627830|SUPERIORITY|||||||0.4|TWO_SIDED|95.0|||||Regression, Linear|||||||0.40
74037351|NCT02128763|147627831|SUPERIORITY|||||||0.77|TWO_SIDED|95.0|||||Regression, Linear|||||||0.77
74037352|NCT02128763|147627832|SUPERIORITY|||||||0.95|TWO_SIDED|95.0|||||Regression, Linear|||||||0.95
74037353|NCT02128763|147627833|SUPERIORITY|||||||0.25|TWO_SIDED|95.0|||||Regression, Linear|||||||0.25
74002646|NCT02254278|147554176|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|Two-sided significance level = 0.05||End of RT||||<0.0001
74002647|NCT02254278|147554176|SUPERIORITY|||||||0.17|||||||Fisher Exact|Two-sided significance level = 0.05||One month after end of RT||||0.17
74002648|NCT02254278|147554176|SUPERIORITY|||||||0.16|||||||Fisher Exact|Two-side significance level = 0.05||Six months after end of RT||||0.16
74002649|NCT02254278|147554176|SUPERIORITY|||||||0.26|||||||Fisher Exact|Two-side significance level = 0.05||One year after end of RT||||0.26
74002650|NCT02254278|147554176|SUPERIORITY|||||||0.82|||||||Fisher Exact|Two-side significance level = 0.05||Two years after the end of RT||||0.82
74002651|NCT02254278|147554178|SUPERIORITY|||||||0.3|||||||binomial test|One-sided significance level = 0.10||Progression-free survival: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.||||0.3
74002652|NCT02254278|147554178|SUPERIORITY|||||||0.07|||||||binomial test|One-sided significance level = 0.10||Local-regional control: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.||||0.07
74037354|NCT02128763|147627834|SUPERIORITY|||||||0.61|TWO_SIDED|95.0|||||Regression, Linear|||||||0.61
74037355|NCT02128763|147627835|SUPERIORITY|||||||0.42|TWO_SIDED|95.0|||||Regression, Linear|||||||0.42
74037356|NCT02128763|147627836|SUPERIORITY|||||||0.6|TWO_SIDED|95.0|||||Chi-squared, Corrected|||||||0.60
74037357|NCT02128763|147627837|SUPERIORITY|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|||||||0.17
74037358|NCT02128763|147627838|SUPERIORITY|||||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||||||0.02
74037359|NCT02128763|147627839|SUPERIORITY|||||||0.71|TWO_SIDED|95.0|||||Regression, Linear|||||||0.71
74037360|NCT02128763|147627840|SUPERIORITY|||||||0.66|TWO_SIDED|95.0|||||Regression, Linear|||||||0.66
74037361|NCT02128763|147627841|SUPERIORITY|||||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||||||0.02
74037362|NCT00363246|147627842|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Chi-squared|||Health Status. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.049
74037363|NCT00363246|147627842|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.013
74037364|NCT00363246|147627842|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Chi-squared|||Pain when transfer. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.0001
74037365|NCT00363246|147627842|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Energy level. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.009
74090912|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.8257|||TWO_SIDED|95.0|-4.7|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-4.7|
74090913|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.98|STANDARD_ERROR_OF_MEAN|1.8254|||TWO_SIDED|95.0|-7.6|-0.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.4|-7.6|
74090914|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.43|STANDARD_ERROR_OF_MEAN|1.8252|||TWO_SIDED|95.0|-6.0|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-6.0|
74002653|NCT02254278|147554179|SUPERIORITY|||||||0.28|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.28
74002654|NCT02254278|147554180|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.03
74002655|NCT02254278|147554184|SUPERIORITY|||||||0.08|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.08
74002656|NCT02254278|147554185|SUPERIORITY|||||||0.02||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.02
74002657|NCT06609135|147554197|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.||||0.045
74002658|NCT06609135|147554198|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.||||0.045
74037366|NCT00363246|147627843|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|We used chi-squared test for categorical variable (most variables) and t-test (2-sided) for continuous variables (few variables).||Health Status. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.033
74037367|NCT00363246|147627843|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.013
74002659|NCT06609135|147554199|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.||||0.49
74002660|NCT06609135|147554200|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.||||0.49
74002661|NCT06609135|147554201|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.||||0.56
74002662|NCT06609135|147554202|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.||||0.56
74002663|NCT06609135|147554203|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of FLS values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.||||0.09
74002664|NCT06609135|147554204|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of FLS values at 31 weeks between participants that were successful in discontinuation of non-invasive ventilation at 32 weeks postmenstrual age and those that were unsuccessful.||||0.09
74037368|NCT00363246|147627843|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Pain when transfer. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||<0.001
74037369|NCT00363246|147627843|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Energy level. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.007
74037370|NCT02121756|147627899|OTHER|The sCD14 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD14||||||0.822|||||||Regression, Linear|||||||0.8220
74037371|NCT02121756|147627900|OTHER|The sCD163 is measured in ng/ml and the median change is shown in ng/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD163.||||||0.0869|||||||Regression, Linear|||||||0.0869
74002665|NCT06609135|147554205|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of FLS values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.||||0.44
74002666|NCT06609135|147554206|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of FLS values at 32 weeks between participants that were successful in discontinuation of non-invasive ventilation at 33 weeks postmenstrual age and those that were unsuccessful.||||0.44
74002667|NCT06609135|147554207|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of FLS values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.||||0.59
74002668|NCT06609135|147554208|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Statistical Analysis assessed correlation of GI values at 34 weeks between participants that were successful in discontinuation of non-invasive ventilation by 36 weeks postmenstrual age and those that were unsuccessful.||||0.59
74002669|NCT03727438|147554216|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|-3.7|||<|0.01|TWO_SIDED|95.0|-5.0|-2.4||alpha=.05|Mixed Models Analysis|Model parameters included a common intercept (baseline means constrained to be equal), stratification variables, timepoint, and arm by timepoint.||"Analyses were conducted according to the intention-to-treat principle. All available data, including observations from participants who dropped out of the study, were used for primary and secondary analyses. Our modeling estimation approach was conducted with full-likelihood methods, providing unbiased treatment effect estimates under a missing-data framework known as missing at random (MAR)."||-2.4|-5.0|<0.01
74002670|NCT03727438|147554217|EQUIVALENCE|alpha= .05|Mean Difference (Final Values)|-19.6|||<|0.01|TWO_SIDED|95.0|-26.7|-12.5||alpha = 0.05|Mixed Models Analysis|||||-12.5|-26.7|<0.01
74002671|NCT03727438|147554218|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|-20.6|||<|0.01|TWO_SIDED|95.0|-29.1|-12.0||alpha = .05|Mixed Models Analysis|||||-12.0|-29.1|<0.01
74002672|NCT03727438|147554219|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|11.0|||<|0.01|TWO_SIDED|95.0|7.7|14.3|||Mixed Models Analysis|alpha = 0.05||||14.3|7.7|<0.01
74002673|NCT03727438|147554220|EQUIVALENCE|Alpha = .05|Mean Difference (Final Values)|-6.2|||>|0.05|TWO_SIDED|95.0|-12.5|0.1||Alpha = .05|Mixed Models Analysis|||||0.1|-12.5|> 0.05
74002674|NCT03727438|147554221|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|0.0|||>|0.05|TWO_SIDED|95.0|-0.4|0.5||alpha =.05|Mixed Models Analysis|||||.5|-.4|>0.05
74002675|NCT03727438|147554222|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|1.5|||<|0.05|TWO_SIDED|95.0|0.2|2.9||alpha = .05|Mixed Models Analysis|||||2.9|0.2|<0.05
74002676|NCT04647253|147554223|SUPERIORITY||Rate difference between treatment groups|-10.8||||0.0025|TWO_SIDED|95.0|-18.4|-3.3||a priori threshold for statistical significance was 0.025|z-test with unpooled variance|||||-3.3|-18.4|0.0025
74002677|NCT06729593|147554224|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.45|2.11||Proportional odds model stratified by disease severity (high flow nasal canula(HFNC)/non-invasive ventilation(NIV) or invasive mechanical ventiliation(IMV)/ECMO) at study entry to determine the odds of being in a better category at day 90.|Proportional odds model||Summary odds ratio for being in a better category, active/placebo (95% confidence interval); pvalue|||2.11|0.45|0.96
74002678|NCT06729593|147554225|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.37|TWO_SIDED|95.0|0.39|1.42|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.42|0.39|0.37
74002679|NCT06729593|147554226|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8|TWO_SIDED|95.0|0.37|2.14|||Regression, Logistic||Odds ratio for active/placebo (95% confidence interval); pvalue|||2.14|0.37|0.80
74002680|NCT06729593|147554227|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.88|TWO_SIDED|95.0|0.64|1.67|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.67|0.64|0.88
74002681|NCT06729593|147554228|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.5|TWO_SIDED|95.0|0.43|1.5|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.50|0.43|0.50
74002682|NCT06729606|147554229|SUPERIORITY||Odds Ratio (OR)|1.11||||0.54|TWO_SIDED|95.0|0.8|1.55||Proportional odds model stratified by disease severity (high flow nasal canula \[HFNC\]/non-invasive ventilation \[NIV\] or invasive mechanical ventiliation \[IMV\]/ECMO) at study entry to determine the odds of being in a better category at day 90.|Proportional odds model||Summary odds ratio for being in a better category, active/placebo (95% confidence interval); pvalue|||1.55|0.80|0.54
74002683|NCT06729606|147554230|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.78|TWO_SIDED|95.0|0.77|1.41|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.41|0.77|0.78
74002684|NCT06729606|147554231|SUPERIORITY||Odds Ratio (OR)|1.4||||0.1|TWO_SIDED|95.0|0.94|2.08|||Regression, Logistic||Odds ratio for active/placebo (95% confidence interval); pvalue|||2.08|0.94|0.10
74002685|NCT06729606|147554232|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.44|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.44|0.95|0.15
74002686|NCT06729606|147554233|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.71|TWO_SIDED|95.0|0.79|1.42|||Cox proportional hazards model||Hazard ratio for active/placebo (95% confidence interval); pvalue|||1.42|0.79|0.71
74002687|NCT05437510|147554238|SUPERIORITY||Efficacy|84.04|||<|0.0001|TWO_SIDED|95.0|69.493|92.411|||Exact method using binomial distribution|||The 2-sided 95% confidence interval (CI) for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.||92.411|69.493|<0.0001
74002688|NCT05437510|147554239|SUPERIORITY||Efficacy|77.71||||0.0014|TWO_SIDED|95.0|39.249|93.432|||Exact method using binomial distribution|||The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.||93.432|39.249|0.0014
74037372|NCT02121756|147627901|OTHER|The IL-6 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma IL-6.||||||0.5027|||||||Regression, Linear|||||||0.5027
74037373|NCT02121756|147627902|OTHER|||||||0.4548|||||||Mixed Models Analysis|||||||0.4548
74037374|NCT02121756|147627904|OTHER|||||||0.7556|||||||Mixed Models Analysis|||||||0.7556
74090915|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.8251|||TWO_SIDED|95.0|-4.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-4.9|
74002689|NCT05437510|147554240|SUPERIORITY||Efficacy|90.7|||<|0.0001|TWO_SIDED|95.0|63.676|98.813||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for France: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||98.813|63.676|<0.0001
74002690|NCT05437510|147554240|SUPERIORITY||Efficacy|83.2||||0.0036|TWO_SIDED|95.0|33.589|97.593||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for UK: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||97.593|33.589|0.0036
74002691|NCT05437510|147554240|SUPERIORITY||Efficacy|74.62||||0.0051|TWO_SIDED|95.0|29.74|92.595||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for Germany: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||92.595|29.740|0.0051
74002692|NCT05437510|147554241|SUPERIORITY||Efficacy|57.97|||<|0.0001|TWO_SIDED|95.0|40.36|70.76|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||70.760|40.360|<0.0001
74002693|NCT05437510|147554241|SUPERIORITY||Efficacy|52.48||||0.0039|TWO_SIDED|95.0|20.121|72.36|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||72.360|20.121|0.0039
74002694|NCT05437510|147554241|SUPERIORITY||Efficacy|58.62||||0.0024|TWO_SIDED|95.0|25.115|78.049|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||78.049|25.115|0.0024
74002695|NCT05437510|147554241|SUPERIORITY||Efficacy|70.74||||0.0037|TWO_SIDED|95.0|29.567|89.396|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||89.396|29.567|0.0037
74037375|NCT02121756|147627905|OTHER|||||||0.2075|||||||Mixed Models Analysis|||||||0.2075
74037376|NCT02121756|147627906|OTHER|||||||0.0315|||||||Mixed Models Analysis|||||||0.0315
74037377|NCT02121756|147627907|OTHER|||||||0.7376|||||||Mixed Models Analysis|||||||0.7376
74002696|NCT05437510|147554242|SUPERIORITY||Efficacy|82.44|||<|0.0001|TWO_SIDED|95.0|67.271|91.357|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.357|67.271|<0.0001
74002697|NCT05437510|147554242|SUPERIORITY||Efficacy|86.11|||<|0.0001|TWO_SIDED|95.0|60.283|96.459|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||96.459|60.283|<0.0001
74002698|NCT05437510|147554242|SUPERIORITY||Efficacy|85.2||||0.0004|TWO_SIDED|95.0|50.084|97.183|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.183|50.084|0.0004
74002699|NCT05437510|147554242|SUPERIORITY||Efficacy|74.36||||0.0055|TWO_SIDED|95.0|29.006|92.518|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||92.518|29.006|0.0055
74037378|NCT02121756|147627908|OTHER|||||||0.2343|||||||Mixed Models Analysis|||||||0.2343
74037379|NCT02121756|147627909|OTHER|||||||0.7598|||||||Mixed Models Analysis|||||||0.7598
74037380|NCT02121756|147627910|OTHER|||||||0.983|||||||Mixed Models Analysis|||||||0.9830
74037381|NCT02121756|147627911|OTHER|||||||0.3317|||||||Mixed Models Analysis|||||||0.3317
74037382|NCT02121756|147627912|OTHER|||||||0.6121|||||||Mixed Models Analysis|||||||0.6121
74037383|NCT02121756|147627913|OTHER|||||||0.562|||||||Mixed Models Analysis|||||||0.5620
74037384|NCT00064350|147627921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Fisher Exact|||Compare the proportion of patients maintaining stable disease or objective response at 2 months after randomization between the two arms.||||0.005
74002700|NCT05437510|147554243|SUPERIORITY||Efficacy|75.31||||0.0013|TWO_SIDED|95.0|38.012|91.747|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.747|38.012|0.0013
74002701|NCT05437510|147554243|SUPERIORITY||Efficacy|78.1||||0.062|TWO_SIDED|95.0|-5.823|97.697|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.697|-5.823|0.0620
74002702|NCT05437510|147554243|SUPERIORITY||Efficacy|91.01||||0.006|TWO_SIDED|95.0|38.156|99.791|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||99.791|38.156|0.0060
74002703|NCT05437510|147554243|SUPERIORITY||Efficacy|26.01||||0.9851|TWO_SIDED|95.0|-337.329|89.162|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||89.162|-337.329|0.9851
74002704|NCT05437510|147554244|SUPERIORITY||Efficacy|43.62|||<|0.0001|TWO_SIDED|95.0|24.677|58.057|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||58.057|24.677|<0.0001
74002705|NCT05437510|147554244|SUPERIORITY||Efficacy|34.78||||0.0754|TWO_SIDED|95.0|-4.148|59.648|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||59.648|-4.148|0.0754
74002706|NCT05437510|147554244|SUPERIORITY||Efficacy|40.67||||0.0177|TWO_SIDED|95.0|8.211|62.156|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||62.156|8.211|0.0177
74002707|NCT05437510|147554244|SUPERIORITY||Efficacy|66.38||||0.0046|TWO_SIDED|95.0|25.952|86.137|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||86.137|25.952|0.0046
74002708|NCT05437510|147554249|SUPERIORITY||Efficacy|82.72|||<|0.0001|TWO_SIDED|95.0|67.826|91.49|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.490|67.826|<0.0001
74002709|NCT05437510|147554249|SUPERIORITY||Efficacy|86.13|||<|0.0001|TWO_SIDED|95.0|60.34|96.464|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||96.464|60.340|<0.0001
74002710|NCT05437510|147554249|SUPERIORITY||Efficacy|85.92||||0.0002|TWO_SIDED|95.0|52.85|97.311|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.311|52.850|0.0002
74002711|NCT05437510|147554249|SUPERIORITY||Efficacy|74.39||||0.0054|TWO_SIDED|95.0|29.077|92.525|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||92.525|29.077|0.0054
74002712|NCT05437510|147554250|SUPERIORITY||Efficacy|41.89|||<|0.0001|TWO_SIDED|95.0|23.073|56.333|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||56.333|23.073|<0.0001
74090916|NCT02037165|147735937|SUPERIORITY_OR_OTHER||Slope|-1.72|STANDARD_ERROR_OF_MEAN|1.825|||TWO_SIDED|95.0|-5.3|1.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-5.3|
74037385|NCT00064350|147627922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Log Rank|||Compare PFS between the Sorafenib arm and the placebo arm||||0.014
74090917|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.23|STANDARD_ERROR_OF_MEAN|1.8251|||TWO_SIDED|95.0|-3.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-3.8|
74002713|NCT05437510|147554250|SUPERIORITY||Efficacy|32.19||||0.1003|TWO_SIDED|95.0|-7.188|57.545|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||57.545|-7.188|0.1003
74002714|NCT05437510|147554250|SUPERIORITY||Efficacy|39.83||||0.0164|TWO_SIDED|95.0|8.449|60.911|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||60.911|8.449|0.0164
74002715|NCT05437510|147554250|SUPERIORITY||Efficacy|64.06||||0.0058|TWO_SIDED|95.0|23.386|84.478|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||84.478|23.386|0.0058
74002716|NCT03454828|147554258|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.399|TWO_SIDED||||||t-test, 2 sided|||||||0.399
74002717|NCT03907410|147554307|SUPERIORITY||Mean Difference (Final Values)|15.0|||||TWO_SIDED|95.0|2.0|28.0||||||Multivariate comparison of Experiment phase adherence (Months 1-3) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.||28|2|
74037386|NCT00064350|147627923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||95.0|||||Log Rank|||Compare OS between the Sorafenib arm and the placebo arm||||0.12
74037387|NCT00838916|147627925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.04|0.27|||ANCOVA|||||0.27|-0.04|
74002718|NCT03907410|147554307|SUPERIORITY||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-20.0|7.0||||||Multivariate comparison of Observation phase adherence (Months 4-6) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.||7|-20|
74002719|NCT05754333|147554325|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.2|1.9|||paired t Test||Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|||1.9|1.2|<0.001
74037388|NCT00838916|147627925|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - insulin glargine) is equal to the pre-specified non-inferiority margin of 0.3%||||||0.0086||||||p-value is for non-inferiority testing of albiglutide versus insulin glargine|t-test, 1 sided|||||||0.0086
74037389|NCT00838916|147627925|SUPERIORITY_OR_OTHER|||||||0.1463||||||p-value is for superiority testing of albiglutide versus insulin glargine|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - insulin glargine) is equal to zero.||||||0.1463
74037390|NCT01244191|147627977|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.8086|TWO_SIDED|95.0|0.841|1.149|||Log Rank||Hazard ratio and the 95% confidence interval from stratified Cox-regression model (adjusting for number of prior therapies, gender, and smoking history).|||1.149|0.841|0.8086
74002720|NCT05754333|147554326|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.2|1.8|||Sign test||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.|||1.8|1.2|<0.001
74002721|NCT05754333|147554327|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.0|1.7|||paired t test||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|||1.7|1.0|<0.001
74002722|NCT05754333|147554329|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|||||
74037391|NCT02164513|147627985|SUPERIORITY||Rate ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.7|0.81||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Negative binomial model||Covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.|||0.81|0.70|<0.001
74002723|NCT05754333|147554330|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|||||
74002724|NCT05754333|147554331|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|||||
74002725|NCT05754333|147554332|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|||||
74002726|NCT05754333|147554333|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.2|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|||||
74002727|NCT05754333|147554334|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.6|||||||||||Mean Difference is calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|||||
74002728|NCT05754333|147554335|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|||||
74002729|NCT05754333|147554336|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|||||
74002730|NCT05754333|147554337|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.2|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|||||
74002731|NCT05754333|147554338|SUPERIORITY||POP with at least 1 Point Higher|67.01|||||||||||||Difference in average index ureter conspicuity scores between NIR-F \& WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 1 point higher. POP meeting this criterion was estimated.|||||
74002732|NCT05754333|147554338|SUPERIORITY||POP with at least 2 point higher|40.4|||||||||||||Difference in average index ureter conspicuity scores between NIR-F \& WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 2 points higher. POP meeting this criterion was estimated.|||||
74002733|NCT05754333|147554338|SUPERIORITY||POP with at least 3 point higher|20.2|||||||||||||Difference in average index ureter conspicuity scores between NIR-F \& WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 3 points higher. POP meeting this criterion was estimated.|||||
74002734|NCT05754333|147554338|SUPERIORITY||POP with at least 4 point higher|2.1|||||||||||||Difference in average index ureter conspicuity scores between NIR-F \& WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 4 points higher. POP meeting this criterion was estimated|||||
74002735|NCT05754333|147554339|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.6|2.2|||paired t test||Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 2||2.2|1.6|<0.001
74002736|NCT05754333|147554339|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.221|||||TWO_SIDED|95.0|-0.011|0.431||||||CCC between BICR and investigator (95% CI), Reader 2||0.431|-0.011|
74002737|NCT05754333|147554339|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.8|1.5|||paired t test||Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 3||1.5|0.8|<0.001
74002738|NCT05754333|147554339|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.053|||||TWO_SIDED|95.0|-0.181|0.282||||||CCC between BICR and investigator (95% CI), Reader 3||0.282|-0.181|
74002739|NCT05754333|147554339|SUPERIORITY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.9|2.6|||paired t test||Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 4||2.6|1.9|<0.001
74002740|NCT05754333|147554339|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.26|||||TWO_SIDED|95.0|0.03|0.464||||||CCC between BICR and investigator (95% CI), Reader 4||0.464|0.030|
74002741|NCT05754333|147554340|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|1.4|2.0|||Sign test||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.|For reader 2||2.0|1.4|<0.001
74002742|NCT05754333|147554340|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.219|||||TWO_SIDED|95.0|-0.013|0.429||||||CCC between BICR and investigator (95% CI), Reader 2||0.429|-0.013|
74002743|NCT05754333|147554340|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.8|1.4|||Sign test||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter(left or right) for eachparticipant.|For reader 3||1.4|0.8|<0.001
74002744|NCT05754333|147554340|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.043|||||TWO_SIDED|95.0|-0.191|0.272||||||CCC between BICR and investigator (95% CI), Reader 3||0.272|-0.191|
74002745|NCT05754333|147554340|SUPERIORITY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.8|2.5|||Sign test||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter(left or right) for eachparticipant.|For reader 4||2.5|1.8|<0.001
74002746|NCT05754333|147554340|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.245|||||TWO_SIDED|95.0|0.014|0.451||||||CCC between BICR and investigator (95% CI), Reader 4||0.451|0.014|
73877912|NCT03084796|147295441|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.273|TWO_SIDED|95.0|-0.023|0.08|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.080|-0.023|0.273
74002747|NCT05754333|147554341|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.1|1.8|||paired t test||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 2||1.8|1.1|<0.001
74002748|NCT05754333|147554341|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.339|||||TWO_SIDED|95.0|0.116|0.529||||||CCC between BICR and investigator (95% CI), Reader 2||0.529|0.116|
74002749|NCT05754333|147554341|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.6|1.3|||paired t test||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 3||1.3|0.6|<0.001
74002750|NCT05754333|147554341|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.186|||||TWO_SIDED|95.0|-0.048|0.4||||||CCC between BICR and investigator (95% CI), Reader 3||0.400|-0.048|
74002751|NCT05754333|147554341|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|1.6|2.3|||paired t test||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 4||2.3|1.6|<0.001
74002752|NCT05754333|147554341|OTHER|It quantifies the degree of concordance between two measurements|correlation coefficient|0.297|||||TWO_SIDED|95.0|0.07|0.495||||||CCC between BICR and investigator (95% CI), Reader 4||0.495|0.070|
74002753|NCT05754333|147554342|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 2||||
74002754|NCT05754333|147554342|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 3||||
74037392|NCT02164513|147627985|SUPERIORITY||Rate ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.9||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons|Negative binomial model||Covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.|||0.90|0.80|<0.001
74037393|NCT02164513|147627986|SUPERIORITY||Mean Difference (Net)|0.097|STANDARD_ERROR_OF_MEAN|0.0061|<|0.001|TWO_SIDED|95.0|0.085|0.109||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI versus (vs) FF/VI at Week 52.|Mixed Models Repeated Measures|||||0.109|0.085|<0.001
74002755|NCT05754333|147554342|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 4||||
74002756|NCT05754333|147554343|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|Difference from WL in Means, Reader 2||||
74002757|NCT05754333|147554343|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|Difference from WL in Means, Reader 3||||
74002758|NCT05754333|147554343|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|Difference from WL in Means, Reader 4||||
74002759|NCT05754333|147554344|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 2||||
74002760|NCT05754333|147554344|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 3||||
74002761|NCT05754333|147554344|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 4||||
74002762|NCT05754333|147554345|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 2||||
74002763|NCT05754333|147554345|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 3||||
74002764|NCT05754333|147554345|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|0.5|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 4||||
74002765|NCT05754333|147554346|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-m in WL score of the ureter of interest (left; right) for each participant.|For reader 2||||
74002766|NCT05754333|147554346|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|For reader 3||||
74002767|NCT05754333|147554346|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|For reader 4||||
74002768|NCT05754333|147554347|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 2||||
74002769|NCT05754333|147554347|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.4|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 3||||
74002770|NCT05754333|147554347|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 4||||
74002771|NCT05754333|147554348|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 2||||
74002772|NCT05754333|147554348|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 3||||
74002773|NCT05754333|147554348|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.|For reader 4||||
74002774|NCT05754333|147554349|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|For reader 2||||
74002775|NCT05754333|147554349|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|For reader 3||||
74037394|NCT02164513|147627987|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.4|-1.1||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI vs FF/VI at Week 52.|Mixed Models Repeated Measures|||||-1.1|-2.4|<0.001
74037395|NCT02164513|147627988|SUPERIORITY||Hazard Ratio (HR)|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.91||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Cox proportional hazard model|||||0.91|0.80|<0.001
74002776|NCT05754333|147554349|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|0.1|||||||||||Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the ureter of interest (left; right) for each participant.|For reader 4||||
74002777|NCT05754333|147554350|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.2|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 2||||
74002778|NCT05754333|147554350|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.2|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 3||||
74002779|NCT05754333|147554350|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.2|||||||||||Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.|For reader 4||||
74037396|NCT02164513|147627988|SUPERIORITY||Hazard Ratio (HR)|0.84|||<|0.001|TWO_SIDED|95.0|0.78|0.91|||Cox proportional hazard model|||||0.91|0.78|<0.001
74037397|NCT02164513|147627989|SUPERIORITY||Rate ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.62|0.75|||Negative binomial Model|||||0.75|0.62|<0.001
74002780|NCT01037244|147554371|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Means|5.04|||<|0.0001|TWO_SIDED|95.0|3.36|6.73|||ANCOVA|Baseline Domain Score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||6.73|3.36|<0.0001
74002781|NCT01037244|147554371|SUPERIORITY_OR_OTHER||Difference in LS Means|7.18|||<|0.0001|TWO_SIDED|95.0|5.49|8.86|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||8.86|5.49|<0.0001
74002782|NCT01037244|147554371|SUPERIORITY_OR_OTHER||Difference in LS Means|7.95|||<|0.0001|TWO_SIDED|95.0|6.27|9.63|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||9.63|6.27|<0.0001
74037398|NCT02164513|147627990|SUPERIORITY||Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.7|0.85|||Cox proportional hazard model|||||0.85|0.70|<0.001
74037399|NCT02164513|147627991|SUPERIORITY||Rate Ratio|0.87||||0.064|TWO_SIDED|95.0|0.76|1.01|||Negative binomial model|||||1.01|0.76|0.064
74037400|NCT02164513|147627991|SUPERIORITY||Rate ratio|0.66|||<|0.001|TWO_SIDED|95.0|0.56|0.78|||Negative binomial model|||||0.78|0.56|<0.001
74002783|NCT01037244|147554372|SUPERIORITY_OR_OTHER||Difference in LS Means|18.6|||<|0.0001|TWO_SIDED|95.0|11.72|25.48|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.48|11.72|<0.0001
74002784|NCT01037244|147554372|SUPERIORITY_OR_OTHER||Difference in LS Means|29.02|||<|0.0001|TWO_SIDED|95.0|22.13|35.9|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||35.90|22.13|<0.0001
74002785|NCT01037244|147554372|SUPERIORITY_OR_OTHER||Difference in LS Means|31.51|||<|0.0001|TWO_SIDED|95.0|24.68|38.34|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||38.34|24.68|<0.0001
74002786|NCT01037244|147554373|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
74002787|NCT01037244|147554373|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
74002788|NCT01037244|147554373|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
74002789|NCT01037244|147554373|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
74002790|NCT01037244|147554374|SUPERIORITY_OR_OTHER||Difference in LS Means|0.44|||<|0.0001|TWO_SIDED|95.0|0.3|0.59|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.59|0.30|<0.0001
73877913|NCT03084796|147295441|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.813|TWO_SIDED|95.0|-0.058|0.045|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.045|-0.058|0.813
74002791|NCT01037244|147554374|SUPERIORITY_OR_OTHER||Difference in LS Means|0.68|||<|0.0001|TWO_SIDED|95.0|0.54|0.83|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.83|0.54|<0.0001
74008816|NCT01499953|147567755|NON_INFERIORITY|The hypotheses for non-inferiority test using ∆=4.5% for the difference between incidence rates were H0: πrivaroxaban-πfondaparinux ≥ 4.5%, H1: πrivaroxaban-πfondaparinux \< 4.5% where πfondaparinux and πrivaroxaban were the incidence rates of CIAC confirmed VTE complications up to Day 45 in the treatment groups. Rejection of the null hypothesis would have concluded that rivaroxaban was not inferior to fondaparinux. To calculate the p-value, an asymptotic test for non-inferiority was used.||||||0.0252|||||||asymptotic test for non-inferiority|||||||0.0252
74008817|NCT00823303|147567761|NON_INFERIORITY_OR_EQUIVALENCE|On the basis of prior published reports, we estimated a 5% rate of hypercalcemia with paricalcitol and a 30% rate with calcitriol. To have a 90% power to detect a difference at the P=0.05 confidence level, 42 patients per group were needed. Assuming a 30% dropout rate over the course of the study, we planned to randomize 110 patients.||||||0.36|||||||Fisher Exact|||||||0.36
74002792|NCT01037244|147554374|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8|||<|0.0001|TWO_SIDED|95.0|0.66|0.95|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.95|0.66|<0.0001
74002793|NCT01037244|147554375|SUPERIORITY_OR_OTHER||Difference in LS Means|16.67|||<|0.0001|TWO_SIDED|95.0|11.23|22.11|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||22.11|11.23|<0.0001
74002794|NCT01037244|147554375|SUPERIORITY_OR_OTHER||Difference in LS Means|22.57|||<|0.0001|TWO_SIDED|95.0|17.11|28.03|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||28.03|17.11|<0.0001
74002795|NCT01037244|147554375|SUPERIORITY_OR_OTHER||Difference in LS Means|28.39|||<|0.0001|TWO_SIDED|95.0|22.98|33.79|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||33.79|22.98|<0.0001
74002796|NCT01037244|147554376|SUPERIORITY_OR_OTHER||Difference in LS Means|1.89|||<|0.0001|TWO_SIDED|95.0|1.17|2.61|||ANCOVA|P-values were obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.61|1.17|<0.0001
74002797|NCT01037244|147554376|SUPERIORITY_OR_OTHER||Difference in LS Means|2.27|||<|0.0001|TWO_SIDED|95.0|1.54|2.99|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.99|1.54|<0.0001
74002798|NCT01037244|147554376|SUPERIORITY_OR_OTHER||Difference in LS Means|3.02|||<|0.0001|TWO_SIDED|95.0|2.3|3.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||3.73|2.30|<0.0001
74037401|NCT03353753|147628007|SUPERIORITY||Hazard Ratio, log|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.25||Two-sided P-value|Log Rank|Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)|Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]|||0.25|0.09|<0.0001
74037402|NCT03353753|147628008|SUPERIORITY|||||||0.0504||||||Two-sided P-value|Fisher Exact|||||||0.0504
74090918|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.8252|||TWO_SIDED|95.0|-5.0|2.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-5.0|
74002799|NCT01037244|147554377|SUPERIORITY_OR_OTHER||Difference in LS Means|1.42|||<|0.0001|TWO_SIDED|95.0|0.81|2.03|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.03|0.81|<0.0001
74002800|NCT01037244|147554377|SUPERIORITY_OR_OTHER||Difference in LS Means|1.65|||<|0.0001|TWO_SIDED|95.0|1.04|2.26|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.26|1.04|<0.0001
74002801|NCT01037244|147554377|SUPERIORITY_OR_OTHER||Difference in LS Means|1.98|||<|0.0001|TWO_SIDED|95.0|1.37|2.59|||ANCOVA|P-values are obtained from ANCOVA model with baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.59|1.37|<0.0001
74002802|NCT01037244|147554378|SUPERIORITY_OR_OTHER||Difference in LS Means|0.57||||0.0019|TWO_SIDED|95.0|0.21|0.93|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.93|0.21|0.0019
74002803|NCT01037244|147554378|SUPERIORITY_OR_OTHER||Difference in LS Means|0.74|||<|0.0001|TWO_SIDED|95.0|0.38|1.1|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||1.10|0.38|<0.0001
74002804|NCT01037244|147554378|SUPERIORITY_OR_OTHER||Difference in LS Means|0.85|||<|0.0001|TWO_SIDED|95.0|0.49|1.21|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||1.21|0.49|<0.0001
74002805|NCT01037244|147554379|SUPERIORITY_OR_OTHER||Difference in LS Means|1.66|||<|0.0001|TWO_SIDED|95.0|1.13|2.19|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.19|1.13|<0.0001
74002806|NCT01037244|147554379|SUPERIORITY_OR_OTHER||Difference in LS Means|1.76|||<|0.0001|TWO_SIDED|95.0|1.23|2.29|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.29|1.23|<0.0001
74002807|NCT01037244|147554379|SUPERIORITY_OR_OTHER||Difference in LS Means|2.56|||<|0.0001|TWO_SIDED|95.0|2.03|3.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||3.09|2.03|<0.0001
74008818|NCT04376827|147567769|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.7807|TWO_SIDED|80.0|0.27|1.41|||log-rank test||Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (\<3 mg/mg and \>=3 mg/mg).|||1.41|0.27|0.7807
74008819|NCT04376827|147567770|SUPERIORITY||Hazard Ratio (HR)|1.52||||0.4654|TWO_SIDED|80.0|0.62|3.85|||long-rank test||Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (\<3 mg/mg and \>=3 mg/mg).|||3.85|0.62|0.4654
74008820|NCT02060383|147567922|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.63|0.08|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (Cushing's vs. Acromegaly; baseline HbA1c \<7% vs ≥7%) as fixed effects.|All Patients||0.08|-0.63|
74008821|NCT02060383|147567922|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-0.96|0.95|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \<7% vs ≥7%) as fixed effects.|Cushing's Disease||0.95|-0.96|
74008822|NCT02060383|147567922|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.74|0.02|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \<7% vs ≥7%) as fixed effects.|Acromegaly||0.02|-0.74|
74008823|NCT00713817|147567992|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.89||||0.273|TWO_SIDED|95.0|-0.78|2.56|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||2.56|-0.78|0.273
74090919|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.65|STANDARD_ERROR_OF_MEAN|1.8254|||TWO_SIDED|95.0|-6.2|0.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-6.2|
74090920|NCT02037165|147735937|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.31|STANDARD_ERROR_OF_MEAN|1.8257|||TWO_SIDED|95.0|-3.9|3.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.3|-3.9|
74090921|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.16|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.8|
73877914|NCT03084796|147295442|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.002|TWO_SIDED|95.0|0.022|0.095|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.095|0.022|0.002
74002808|NCT01037244|147554380|SUPERIORITY_OR_OTHER||Difference in LS Means|12.34|||<|0.0001|TWO_SIDED|95.0|7.29|17.4|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||17.40|7.29|<0.0001
74002809|NCT01037244|147554380|SUPERIORITY_OR_OTHER||Difference in LS Means|19.29|||<|0.0001|TWO_SIDED|95.0|14.23|24.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||24.36|14.23|<0.0001
74002810|NCT01037244|147554380|SUPERIORITY_OR_OTHER||Difference in LS Means|19.16|||<|0.0001|TWO_SIDED|95.0|14.14|24.18|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled sites as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||24.18|14.14|<0.0001
74002811|NCT01037244|147554381|SUPERIORITY_OR_OTHER||Difference in LS Means|18.07|||<|0.0001|TWO_SIDED|95.0|10.7|25.43|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.43|10.70|<0.0001
74002812|NCT01037244|147554381|SUPERIORITY_OR_OTHER||Difference in LS Means|23.53|||<|0.0001|TWO_SIDED|95.0|16.12|30.94|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||30.94|16.12|<0.0001
74008824|NCT00713817|147567993|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|4.62||||0.296|TWO_SIDED|95.0|-4.51|13.75|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||13.75|-4.51|0.296
73877915|NCT03084796|147295442|SUPERIORITY||Mean Difference (Final Values)|0.077|||<|0.001|TWO_SIDED|95.0|0.04|0.113|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.113|0.040|<0.001
74002813|NCT01037244|147554381|SUPERIORITY_OR_OTHER||Difference in LS Means|36.25|||<|0.0001|TWO_SIDED|95.0|28.92|43.59|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||43.59|28.92|<0.0001
74002814|NCT01037244|147554382|SUPERIORITY_OR_OTHER||Difference in LS Means|18.2|||<|0.0001|TWO_SIDED|95.0|10.79|25.6|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.60|10.79|<0.0001
74002815|NCT01037244|147554382|SUPERIORITY_OR_OTHER||Difference in LS Means|25.25|||<|0.0001|TWO_SIDED|95.0|17.82|32.69|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||32.69|17.82|<0.0001
74002816|NCT01037244|147554382|SUPERIORITY_OR_OTHER||Difference in LS Means|36.99|||<|0.0001|TWO_SIDED|95.0|29.63|44.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||44.36|29.63|<0.0001
74002817|NCT01037244|147554383|SUPERIORITY_OR_OTHER||Difference in LS Means|19.98|||<|0.0001|TWO_SIDED|95.0|12.69|27.26|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||27.26|12.69|<0.0001
74002818|NCT01037244|147554383|SUPERIORITY_OR_OTHER||Difference in LS Means|27.58|||<|0.0001|TWO_SIDED|95.0|20.29|34.88|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||34.88|20.29|<0.0001
74002819|NCT01037244|147554383|SUPERIORITY_OR_OTHER||Difference in LS Means|37.8|||<|0.0001|TWO_SIDED|95.0|30.57|45.03|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||45.03|30.57|<0.0001
74002820|NCT01616056|147554433|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
74002821|NCT01616056|147554435|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
74002822|NCT01616056|147554437|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74002823|NCT01616056|147554440|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
74008825|NCT00713817|147567994|SUPERIORITY_OR_OTHER_LEGACY||Chi-square|0.048||||0.826||95.0|||||Log Rank|||Time to treatment failure was analysed using Kaplan-Meier Survival analysis methodology. The difference in loss of response cumulative distribution function between treatments was assessed using the Hodges-Lehmann estimate.||||0.826
74008826|NCT00713817|147567995|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.14||||0.54|TWO_SIDED|95.0|-39.7|9.62|||Hodges-Lehmann|||The difference in loss of response cumulative distribution functions between treatments was assessed using the Wilcoxon test with an estimate of the median difference between groups in response level (percent change from baseline) provided by the Hodges-Lehmann estimator.||9.62|-39.7|0.54
74008827|NCT00713817|147567996|SUPERIORITY_OR_OTHER_LEGACY||Estimate mean treatment difference|-0.08||||0.902|TWO_SIDED|95.0|-1.45|1.29|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||1.29|-1.45|0.902
74037403|NCT03353753|147628010|SUPERIORITY||Hazard Ratio (HR)|0.36||||0.0004|TWO_SIDED|95.0|0.21|0.62||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR and OS.|Log Rank|Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)|Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]|||0.62|0.21|0.0004
74037404|NCT03353753|147628011|SUPERIORITY|||||||0.001||||||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.|ANCOVA|Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)||||||0.001
74002824|NCT01249274|147554442|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19||||0.01|TWO_SIDED|95.0|1.04|1.36|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is the risk ratio estimate for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for the treatment variable.|||1.36|1.04|0.010
74002825|NCT01249274|147554443|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|30.39||||0.003|TWO_SIDED|95.0|3.18|290.04|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment\*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||290.04|3.18|0.003
74037405|NCT03353753|147628012|SUPERIORITY|||||||0.004||||||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.|ANCOVA|Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)||||||0.004
74037406|NCT03353753|147628013|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
74037407|NCT02093234|147628029|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74037408|NCT02093234|147628030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74037409|NCT02093234|147628031|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74037410|NCT02093234|147628032|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon signed rank|||||||0.02
74037411|NCT00421603|147628106|NON_INFERIORITY_OR_EQUIVALENCE|All analyses were conducted on the intent-to-treat sample of all randomized patients. All statistical tests were 2-tailed and employed at a significance level of 5%, unless otherwise stated. The original sample size of 120 patients was chosen to ensure sufficient power (at least 80%) of a two-sided test with level of significance α=0.05 for detecting difference between the two experimental treatments with respect to the percentage of subjects who achieve continuous 3-weeks abstinence.|||||=|0.05|||||||Chi-squared, Corrected|||The dichotomous primary outcome was analyzed using logistic regression with independent predictors: treatment (MAS-ER and topiramate vs. placebo) and adjusted for baseline severity of cocaine use (total number of cocaine use days in the 28 days prior to randomization).||||=.05
74002826|NCT01249274|147554443|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|16.65||||0.038|TWO_SIDED|95.0|1.18|235.52|||Generalized Estimating Equation||Estimated value is RR for treatment\*time interaction term for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 and 3-month post-trial follow-up. Treatment variable reference group was progesterone.|Negative binomial distribution, log link, and first-order autoregressive covariance structure||235.52|1.18|0.038
74037412|NCT03004469|147628133|OTHER||LS Mean Difference|13.6|STANDARD_ERROR_OF_MEAN|3.94|<|0.001|TWO_SIDED|95.0|5.8|21.3|||Mixed linear model|||||21.3|5.8|<.001
74037413|NCT03004469|147628134|OTHER||LS Mean Difference|12.8|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|6.5|19.1|||Mixed linear model|||||19.1|6.5|<.001
74037414|NCT03004469|147628135|OTHER||LS Mean Difference|-0.4024|STANDARD_ERROR_OF_MEAN|0.4057||0.322|TWO_SIDED|95.0|-1.202|0.3971|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.3971|-1.2020|0.322
74037415|NCT03004469|147628135|OTHER||LS Mean Difference|0.7237|STANDARD_ERROR_OF_MEAN|0.47799||0.131|TWO_SIDED|95.0|-0.2184|1.6657|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||1.6657|-0.2184|0.131
74037416|NCT03004469|147628136|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.569|TWO_SIDED|95.0|-0.3|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.2|-0.3|0.569
74037417|NCT03004469|147628136|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.129|TWO_SIDED|95.0|-0.4|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.1|-0.4|0.129
74037418|NCT03004469|147628137|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.708|TWO_SIDED|95.0|-0.2|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.3|-0.2|0.708
74037419|NCT03004469|147628137|OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.2|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.7|0.2|<.001
74037420|NCT03004469|147628138|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.179|TWO_SIDED|95.0|-0.3|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.1|-0.3|0.179
74037421|NCT03004469|147628138|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.262|TWO_SIDED|95.0|-0.1|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.4|-0.1|0.262
74037422|NCT03004469|147628139|OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.03||0.103|TWO_SIDED|95.0|-3.7|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 4||0.3|-3.7|0.103
74037423|NCT03004469|147628139|OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.1||0.545|TWO_SIDED|95.0|-2.8|1.5|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 8||1.5|-2.8|0.545
74037424|NCT03004469|147628139|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0||0.842|TWO_SIDED|95.0|-2.2|1.8|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 12||1.8|-2.2|0.842
74037425|NCT03004469|147628139|OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.02||0.449|TWO_SIDED|95.0|-2.8|1.2|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 24||1.2|-2.8|0.449
74002827|NCT01249274|147554444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.87|1.15|||Generalized Estimating Equation||Estimated value is the risk ratio for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for treatment.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||1.15|0.87|0.99
74002828|NCT01249274|147554445|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.34||||0.75|TWO_SIDED|95.0|0.23|7.88|||Generalized Estimating Equation||Estimated value is RR for treatment\*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||7.88|0.23|0.75
74002829|NCT01249274|147554445|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.84|TWO_SIDED|95.0|0.24|5.84|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment\*time interaction for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|||5.84|0.24|0.84
74002830|NCT01249274|147554446|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Fisher Exact|||||||0.1030
74002831|NCT01249274|147554447|SUPERIORITY_OR_OTHER||Score Statistic For Type 3 GEE Analysis|0.01||||0.9116|TWO_SIDED||||||Generalized Estimating Equation|Gamma distribution, logit link, 1st-order autoregressive covariance structure; p-value is for chi-sq (df=1) for type 3 GEE analysis score statistic|Estimated value is chi-sq (df=1) for type 3 GEE analysis score statistic for week\*treatment interaction term.|||||0.9116
74002832|NCT01249274|147554450|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|4.71||||0.048|TWO_SIDED|95.0|1.09|20.5|||Regression, Cox||Ratio presented is for placebo versus progesterone|||20.50|1.09|0.048
74002833|NCT01249274|147554451|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.5||||0.06|TWO_SIDED|95.0|0.92|13.3|||Regression, Cox||Ratio presented is for placebo versus progesterone|||13.30|0.92|0.06
74002834|NCT00138671|147554465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||90.0|-0.17|0.36||||||Week 6||0.36|-0.17|
74037426|NCT03004469|147628139|OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.28||0.272|TWO_SIDED|95.0|-0.2|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 4||0.9|-0.2|0.272
74037427|NCT03004469|147628139|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.36||0.918|TWO_SIDED|95.0|-0.7|0.8|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 8||0.8|-0.7|0.918
73877916|NCT03084796|147295442|SUPERIORITY||Mean Difference (Final Values)|0.126|||<|0.001|TWO_SIDED|95.0|0.089|0.163|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.163|0.089|<0.001
74002835|NCT00138671|147554465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||||90.0|-0.27|0.26||||||Week 12||0.26|-0.27|
74002836|NCT00138671|147554465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||||90.0|-0.29|0.26||||||Week 26||0.26|-0.29|
74002837|NCT00138671|147554465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||||90.0|-0.36|0.2||||||Week 39||0.20|-0.36|
74002838|NCT00138671|147554465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||||90.0|-0.23|0.35||||||Week 52||0.35|-0.23|
74002839|NCT00138671|147554465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||||90.0|-0.29|0.31||||||Week 52 LOCF||0.31|-0.29|
74002840|NCT00138671|147554466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.475||||||90.0|-23.47|14.518||||||Week 6||14.518|-23.47|
74002841|NCT00138671|147554466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.91||||||90.0|-30.04|8.232||||||Week 12||8.232|-30.04|
74002842|NCT00138671|147554466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.84||||||90.0|-42.51|-3.166||||||Week 26||-3.166|-42.51|
74002843|NCT00138671|147554466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.222||||||90.0|-28.52|12.075||||||Week 39||12.075|-28.52|
74002844|NCT00138671|147554466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.329||||||90.0|-29.27|12.616||||||Week 52||12.616|-29.27|
74002845|NCT00138671|147554466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.406||||||90.0|-13.7|16.514||||||Week 52 LOCF||16.514|-13.70|
74002846|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.884||||||90.0|-0.317|2.084||||||Week 1||2.084|-0.317|
74002847|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||||90.0|-0.728|1.668||||||Week 2||1.668|-0.728|
74002848|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.382||||||90.0|-0.815|1.579||||||Week 3||1.579|-0.815|
74002849|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.405||||||90.0|-0.793|1.602||||||Week 4||1.602|-0.793|
74002850|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.562||||||90.0|-0.642|1.766||||||Week 6||1.766|-0.642|
74002851|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.416||||||90.0|-0.809|1.641||||||Week 9||1.641|-0.809|
74002852|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019||||||90.0|-1.416|1.454||||||Week 11||1.454|-1.416|
74002853|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091||||||90.0|-1.127|1.308||||||Week 12||1.308|-1.127|
74002854|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.309||||||90.0|-1.551|0.934||||||Week 18||0.934|-1.551|
74002855|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.869||||||90.0|-2.123|0.384||||||Week 26||0.384|-2.123|
74002856|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.664||||||90.0|-2.968|-0.36||||||Week 39||-0.360|-2.968|
74002857|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.116||||||90.0|-3.829|-0.403||||||Week 50||-0.403|-3.829|
74002858|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.801||||||90.0|-3.204|-0.397||||||Week 51||-0.397|-3.204|
74037428|NCT03004469|147628139|OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.078||0.078|TWO_SIDED|95.0|-0.1|1.1|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 12||1.1|-0.1|0.078
74037429|NCT03004469|147628139|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.593|TWO_SIDED|95.0|-0.9|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 24||0.5|-0.9|0.593
73877917|NCT03084796|147295442|SUPERIORITY||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.104|0.177|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.177|0.104|<0.001
74002859|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.026||||||90.0|-3.384|-0.668||||||Week 52||-0.668|-3.384|
74002860|NCT00138671|147554467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.451||||||90.0|-3.003|0.101||||||Week 52 LOCF||0.101|-3.003|
74002861|NCT01831856|147554484|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5749|TWO_SIDED|95.0|0.71|1.85|||Log Rank|||The primary criterion, time to first Atrial Fibrillation (AF) recurrence or atrial flutter emergence, was described using survival curves according to the Kaplan-Meier method, reporting the first and third quartiles (Q1, Q3), median, and 95% confidence interval. The time to first AF recurrence or atrial flutter emergence was compared between treatment groups using the Log rank test. Hazard ratios and 95% confidence intervals were estimated with the Cox regression model.||1.85|0.71|0.5749
74002862|NCT01498653|147554485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|28.5|||<|0.001|TWO_SIDED|95.0|20.1|36.9|||ANCOVA|||||36.9|20.1|<0.001
74002863|NCT00298090|147554501|SUPERIORITY_OR_OTHER||Other|0.0||||0.55|TWO_SIDED|95.0|-0.8|1.48|||repeated measures model||A repeated measures model was used to assess whether the one-minute average StO2 values differed systematically between pre and post arterial line placement.|||1.48|-0.80|0.55
74002864|NCT01078675|147554524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.88|STANDARD_DEVIATION|18.222|<|0.001|TWO_SIDED|-42.88|-45.44|-40.32||P-value\<0.001 at Month 24. No adjustment for multiple comparisons is made for individual age group.|ANCOVA|P-value is two-sided and based on ANCOVA using age group as the fixed factor, and study centre and the baseline value as covariates.||||-40.32|-45.44|<0.001
74002865|NCT01191268|147554549|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||The study was designed to enroll 837 randomized participants (279 per treatment arm) with 90% power to detect non-inferiority of 1.5 mg LY2189265 versus Insulin Glargine on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 248 participants per arm, with an assumed drop-out rate of 11%.||-0.07|-0.38|<0.001
74037430|NCT03004469|147628139|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.295|TWO_SIDED|95.0|-0.7|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 4||0.2|-0.7|0.295
74037431|NCT03004469|147628139|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.926|TWO_SIDED|95.0|-0.5|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 8||0.4|-0.5|0.926
74037432|NCT03004469|147628139|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.183|TWO_SIDED|95.0|-0.7|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 12||0.1|-0.7|0.183
74037433|NCT03004469|147628139|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.981|TWO_SIDED|95.0|-0.4|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 24||0.5|-0.4|0.981
74037434|NCT03004469|147628139|OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.66||0.041|TWO_SIDED|95.0|-2.7|-0.1|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 4||-0.1|-2.7|0.041
74037435|NCT03004469|147628139|OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.67||0.562|TWO_SIDED|95.0|-1.7|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 8||0.9|-1.7|0.562
74037436|NCT03004469|147628139|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.66||0.642|TWO_SIDED|95.0|-1.6|1.0|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 12||1.0|-1.6|0.642
74037437|NCT03004469|147628139|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.65||0.156|TWO_SIDED|95.0|-2.2|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 24||0.4|-2.2|0.156
74037438|NCT03004469|147628139|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.29||0.824|TWO_SIDED|95.0|-0.6|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 4||0.5|-0.6|0.824
74037439|NCT03004469|147628139|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.29||0.713|TWO_SIDED|95.0|-0.5|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 8||0.7|-0.5|0.713
74037440|NCT03004469|147628139|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.993|TWO_SIDED|95.0|-0.6|0.6|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 12||0.6|-0.6|0.993
74037441|NCT03004469|147628139|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.55|TWO_SIDED|95.0|-0.8|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 24||0.4|-0.8|0.550
74037442|NCT05137730|147628239|OTHER||Ratio of geometric least squares means|0.78|||||TWO_SIDED|90.0|0.7109|0.8611|||||Least squares means (LSMs) were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.8611|0.7109|
74037443|NCT05137730|147628240|OTHER||Dose effect|1.5395|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|1.2929|1.7862||||||A linear regression model was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.7862|1.2929|
74002866|NCT01191268|147554549|NON_INFERIORITY_OR_EQUIVALENCE|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.02|-0.33|<0.001
74037444|NCT05137730|147628241|OTHER||Ratio of geometric least squares means|0.84|||||TWO_SIDED|90.0|0.7576|0.9375|||||LSMs were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.9375|0.7576|
74002867|NCT01191268|147554549|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.005|TWO_SIDED|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.07|-0.38|0.005
74002868|NCT01191268|147554549|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.015|TWO_SIDED|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.02|-0.33|0.015
74002869|NCT01191268|147554550|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.25|||<|0.001|TWO_SIDED|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.07|-0.42|<0.001
74002870|NCT01191268|147554550|NON_INFERIORITY_OR_EQUIVALENCE|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.19|||<|0.001|TWO_SIDED|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.02|-0.37|<0.001
74002871|NCT01191268|147554550|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.005|TWO_SIDED|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.07|-0.42|0.005
74002872|NCT01191268|147554550|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.014|TWO_SIDED|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.02|-0.37|0.014
74002873|NCT01191268|147554551|SUPERIORITY_OR_OTHER|||||||0.014||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.014
74002874|NCT01191268|147554551|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.010
74090922|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|2.18|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-0.5|4.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.9|-0.5|
74002875|NCT01191268|147554551|SUPERIORITY_OR_OTHER|||||||0.027||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.027
74002876|NCT01191268|147554551|SUPERIORITY_OR_OTHER|||||||0.384||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.384
74002877|NCT01191268|147554551|SUPERIORITY_OR_OTHER||||||<|0.05||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||<0.05
74002878|NCT01191268|147554551|SUPERIORITY_OR_OTHER|||||||0.25||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.250
74002879|NCT01191268|147554551|SUPERIORITY_OR_OTHER|||||||0.272||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.272
74002880|NCT01191268|147554551|SUPERIORITY_OR_OTHER|||||||0.623||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.623
74002881|NCT01191268|147554552|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic|||||||<0.001
74002882|NCT01191268|147554552|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic|||||||<0.001
74002883|NCT01191268|147554552|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic|||||||<0.001
74002884|NCT01191268|147554552|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic|||||||<0.001
74002885|NCT01191268|147554553|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.628|TWO_SIDED|95.0|-0.35|0.21||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis|||||0.21|-0.35|0.628
74002886|NCT01191268|147554553|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.368|TWO_SIDED|95.0|-0.15|0.41||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis|||||0.41|-0.15|0.368
74002887|NCT01191268|147554553|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.37|TWO_SIDED|95.0|-0.16|0.42||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis|||||0.42|-0.16|0.370
74002888|NCT01191268|147554553|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.879|TWO_SIDED|95.0|-0.26|0.3||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis|||||0.30|-0.26|0.879
74002889|NCT01191268|147554554|SUPERIORITY_OR_OTHER||LS Mean Difference|1.31|||<|0.001|TWO_SIDED|95.0|0.83|1.79||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||1.79|0.83|<0.001
74002890|NCT01191268|147554554|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|||<|0.001|TWO_SIDED|95.0|1.32|2.28||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||2.28|1.32|<0.001
74002891|NCT01191268|147554554|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.55|1.64||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||1.64|0.55|<0.001
74002892|NCT01191268|147554554|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|0.88|1.96||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||1.96|0.88|<0.001
74002893|NCT01191268|147554556|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2|||<|0.001|TWO_SIDED|95.0|-3.81|-2.59||Treatment comparison at 26 weeks.|ANCOVA|||||-2.59|-3.81|<0.001
74002894|NCT01191268|147554556|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.15|||<|0.001|TWO_SIDED|95.0|-2.76|-1.54||Treatment comparison at 26 weeks.|ANCOVA|||||-1.54|-2.76|<0.001
74002895|NCT01191268|147554556|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.23|||<|0.001|TWO_SIDED|95.0|-3.99|-2.48||Treatment comparison at 52 weeks.|ANCOVA|||||-2.48|-3.99|<0.001
74002896|NCT01191268|147554556|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.03|||<|0.001|TWO_SIDED|95.0|-2.78|-1.27||Treatment comparison at 52 weeks.|ANCOVA|||||-1.27|-2.78|<0.001
74002897|NCT01191268|147554558|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.44|-0.96||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-0.96|-1.44|<0.001
74002898|NCT01191268|147554558|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79|||<|0.001|TWO_SIDED|95.0|-1.03|-0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-0.55|-1.03|<0.001
74002899|NCT01191268|147554558|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.24|||<|0.001|TWO_SIDED|95.0|-1.55|-0.94||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||-0.94|-1.55|<0.001
74002900|NCT01191268|147554558|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.06|-0.46||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||-0.46|-1.06|<0.001
74002901|NCT02294227|147554580|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0002|TWO_SIDED|95.0|1.66|5.66|||Chi-squared|||||5.66|1.66|0.0002
74002902|NCT02294227|147554580|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0003|TWO_SIDED|95.0|1.76|5.97|||Chi-squared, Corrected|||||5.97|1.76|0.0003
74002903|NCT00899548|147554590|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.0002|TWO_SIDED|95.0|1.23|2.52|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.||||2.52|1.23|.0002
74002904|NCT00899548|147554591|OTHER||Cox Proportional Hazard|1.19||||0.001|TWO_SIDED|95.0|1.07|1.32|||Regression, Cox|||Hazard ratio||1.32|1.07|0.001
74002905|NCT00899548|147554594|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.001|TWO_SIDED|95.0|1.18|2.45|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.||||2.45|1.18|.001
74002906|NCT00511472|147554601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.1|STANDARD_ERROR_OF_MEAN|14.15||0.001|TWO_SIDED|90.0|22.71|69.5|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-Breakfast for Titration Group 1||69.50|22.71|0.001
74037445|NCT05137730|147628242|OTHER||Dose effect|1.2823|STANDARD_ERROR_OF_MEAN|0.1072|||TWO_SIDED|95.0|1.0431|1.5215||||||A linear regression model using was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.5215|1.0431|
74037446|NCT05137730|147628243|OTHER||Ratio of geometric least squares means|0.81|||||TWO_SIDED|90.0|0.7462|0.8893|||||LSMs were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.8893|0.7462|
74037447|NCT05137730|147628244|OTHER||Dose effect|1.0937|STANDARD_ERROR_OF_MEAN|0.0763|||TWO_SIDED|95.0|0.938|1.2493||||||A linear regression model was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.2493|0.9380|
74037448|NCT01940510|147628253|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|26.8|||||TWO_SIDED|90.0|23.8|30.1|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals.||30.1|23.8|
74002907|NCT00511472|147554601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.28|STANDARD_ERROR_OF_MEAN|13.67|<|0.001|TWO_SIDED|90.0|27.68|72.88|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-breakfast for Titration Group 2||72.88|27.68|<0.001
74002908|NCT04947527|147554612|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.279|TWO_SIDED|95.0|-4.2|1.2|||t-test, 2 sided|||||1.2|-4.2|0.279
74002909|NCT04947527|147554613|SUPERIORITY||Difference in percentages/proportions|-14.4||||0.023|TWO_SIDED|95.0|-26.7|-2.1|||Chi-squared|||||-2.1|-26.7|0.023
74002910|NCT04947527|147554614|SUPERIORITY||Risk Difference (RD)|-0.09||||0.133|TWO_SIDED||||||Fisher Exact|||||||0.133
74002911|NCT03660826|147554654|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.93|TWO_SIDED|95.0|0.91|2.3||Comparing Arm II vs Arm I (reference group)|Log Rank||||Comparing Arm II vs Arm I (reference group)|2.30|0.91|0.93
74002912|NCT03660826|147554654|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.06|TWO_SIDED|95.0|0.43|1.14|||Log Rank|||Comparing Arm III vs Arm I||1.14|0.43|0.06
74002913|NCT03660826|147554654|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.62|TWO_SIDED|95.0|0.67|1.7|||Log Rank|||Comparing Arm IV vs Arm VII||1.70|0.67|0.62
74002914|NCT03660826|147554654|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.36|TWO_SIDED|95.0|0.58|1.46|||Log Rank|||Comparing Arm V vs Arm VII||1.46|0.58|0.36
74002915|NCT03660826|147554654|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.14|TWO_SIDED|95.0|0.49|1.25|||Log Rank|||Comparing Arm VI vs VII||1.25|0.49|0.14
74002916|NCT03938545|147554663|SUPERIORITY||Risk Difference (RD)|21.4|||=|0.1993|TWO_SIDED|95.0|-11.3|54.1||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 680 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||54.1|-11.3|=0.1993
74002917|NCT03938545|147554663|SUPERIORITY||Risk Difference (RD)|24.2|||=|0.1016|TWO_SIDED|95.0|-4.8|53.2||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 340 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||53.2|-4.8|=0.1016
74002918|NCT03938545|147554663|SUPERIORITY||Risk Difference (RD)|-8.3|||=|0.2963|TWO_SIDED|95.0|-24.0|7.3||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 255 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||7.3|-24.0|=0.2963
74002919|NCT03938545|147554665|SUPERIORITY||Least Square Mean Difference|-60.085|||<|0.001|TWO_SIDED|95.0|-88.857|-31.313|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-31.313|-88.857|<0.001
74002920|NCT03938545|147554665|SUPERIORITY||Least Square Mean Difference|-65.143|||<|0.001|TWO_SIDED|95.0|-91.927|-38.358|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-38.358|-91.927|<0.001
74002921|NCT03938545|147554665|SUPERIORITY||Least Square Mean Difference|-37.323|||=|0.0284|TWO_SIDED|95.0|-70.455|-4.19|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-4.190|-70.455|=0.0284
74037449|NCT01940510|147628254|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|48.6|||||TWO_SIDED|90.0|43.5|54.3|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||54.3|43.5|
74037450|NCT01940510|147628255|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|179.0|||||TWO_SIDED|90.0|158.0|202.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||202|158|
73877918|NCT03084796|147295442|SUPERIORITY||Mean Difference (Final Values)|0.183|||<|0.001|TWO_SIDED|95.0|0.147|0.22|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.220|0.147|<0.001
74002922|NCT03938545|147554666|SUPERIORITY||Least Square Mean Difference|-73.003|||<|0.001|TWO_SIDED|95.0|-82.309|-63.697|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-63.697|-82.309|<0.001
74002923|NCT03938545|147554666|SUPERIORITY||Least Square Mean Difference|-59.005|||<|0.001|TWO_SIDED|95.0|-67.821|-50.19|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-50.190|-67.821|<0.001
74002924|NCT03938545|147554666|SUPERIORITY||Least Square Mean Difference|-51.836|||<|0.001|TWO_SIDED|95.0|-62.66|-41.012|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-41.012|-62.660|<0.001
74002925|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-81.49|||<|0.001|TWO_SIDED|95.0|-93.203|-69.777|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-69.777|-93.203|<0.001
74002926|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-67.591|||<|0.001|TWO_SIDED|95.0|-78.562|-56.62|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-56.620|-78.562|<0.001
74002927|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-67.233|||<|0.001|TWO_SIDED|95.0|-81.073|-53.394|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-53.394|-81.073|<0.001
74037451|NCT01940510|147628256|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|220.0|||||TWO_SIDED|90.0|190.0|255.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||255|190|
74037452|NCT00091026|147628274|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.22|TWO_SIDED|95.0|-13.0|14.0|||Chi-squared|||||14|-13|0.22
74037453|NCT00091026|147628275|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Log Rank|||||||0.95
74037454|NCT00091026|147628276|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Log Rank|||||||0.86
73877919|NCT03084796|147295442|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.322|TWO_SIDED|95.0|-0.018|0.055|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.055|-0.018|0.322
73877920|NCT03084796|147295442|SUPERIORITY||Mean Difference (Final Values)|0.067|||<|0.001|TWO_SIDED|95.0|0.031|0.104|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.104|0.031|<0.001
74002928|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-74.865|||<|0.001|TWO_SIDED|95.0|-86.898|-62.832|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-62.832|-86.898|<0.001
74002929|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-53.198|||<|0.001|TWO_SIDED|95.0|-64.799|-41.596|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-41.596|-64.799|<0.001
74002930|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-53.398|||<|0.001|TWO_SIDED|95.0|-67.552|-39.245|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-39.245|-67.552|<0.001
74002931|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-88.764|||<|0.001|TWO_SIDED|95.0|-103.039|-74.489|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-74.489|-103.039|<0.001
74002932|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-65.714|||<|0.001|TWO_SIDED|95.0|-78.742|-52.686|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-52.686|-78.742|<0.001
74002933|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-66.685|||<|0.001|TWO_SIDED|95.0|-83.157|-50.214|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-50.214|-83.157|<0.001
74002934|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-68.722|||<|0.001|TWO_SIDED|95.0|-80.877|-56.568|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-56.568|-80.877|<0.001
74002935|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-55.554|||<|0.001|TWO_SIDED|95.0|-67.182|-43.926|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-43.926|-67.182|<0.001
74002936|NCT03938545|147554667|SUPERIORITY||Least Square Mean Difference|-53.079|||<|0.001|TWO_SIDED|95.0|-67.948|-38.21|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-38.210|-67.948|<0.001
74002937|NCT01060540|147554668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.44|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|Adjusted for family history (low/unknown vs. high/moderate) and BMI\>=35 (yes vs no) stratification variables||||0.7|-0.3|0.44
74037455|NCT00441103|147628286|SUPERIORITY_OR_OTHER||||||<|0.001||||||Non-parametric analysis of variance (ANOVA) with effects for treatment and the absence/presence of Gd-enhancing lesions at baseline as factors|ANOVA|||||||<0.001
74037456|NCT00441103|147628287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_DEVIATION|2.33|<|0.001|||||||Wilcoxon signed-rank test|||Mean difference was calculated by subtracting 'Day 1 up to Week 16' from 'Week 17 up to Week 40' and analyzed using Wilcoxon signed-rank test.||||<0.001
74037457|NCT02802878|147628296|SUPERIORITY|||||||0.67||||||Adjusted for two observations per subject.|Regression, Linear|Side treated as a repeated factor||||||.67
74037458|NCT01599754|147628301|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.3211|TWO_SIDED|95.0|0.66|1.147|||Log Rank|||||1.147|0.660|0.3211
74037459|NCT01599754|147628302|SUPERIORITY||Hazard Ratio (HR)|1.026||||0.9246|TWO_SIDED|95.0|0.6|1.756|||Log Rank|||||1.756|0.600|0.9246
74002938|NCT01060540|147554669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.19|TWO_SIDED|95.0|-0.1|0.3||adjusted for baseline BMI class and family history level stratification variables|Mixed Models Analysis|||||0.3|-0.1|0.19
74002939|NCT01060540|147554670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.38|TWO_SIDED|95.0|-0.4|0.1||adjusted for stratification variables baseline BMI and family history|Mixed Models Analysis|||||0.1|-0.4|0.38
74002940|NCT01060540|147554671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.05|TWO_SIDED|95.0|-0.2|0.0||adjusted for baseline family history and BMI|Mixed Models Analysis|||||0.0|-0.2|0.05
74002941|NCT01060540|147554672|SUPERIORITY_OR_OTHER||incident rate ratio|0.9||||0.68|TWO_SIDED|95.0|0.7|1.2||adjusted for baseline family history and BMI|generalized linear model for count data|||||1.2|0.7|0.68
74002942|NCT02647320|147554674|OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.157||0.755|TWO_SIDED|90.0|-0.211|0.309|||Mixed Model Repeated Measure|||Difference in change at week 12||0.309|-0.211|.755
74002943|NCT02647320|147554674|OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.161||0.512|TWO_SIDED|90.0|-0.16|0.371|||Mixed Model Repeated Measure|||Difference in change at week 12||0.371|-0.160|.512
74002944|NCT02647320|147554674|OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.566|TWO_SIDED|90.0|-0.312|0.151|||Mixed Model Repeated Measure|||Difference in change at week 12||0.151|-0.312|.566
74002945|NCT02647320|147554674|OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.139||0.002|TWO_SIDED|90.0|-0.655|-0.197|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.197|-0.655|.002
74002946|NCT02647320|147554675|OTHER||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|3.13||0.144|TWO_SIDED|90.0|-9.76|0.58|||Mixed Model Repeated Measure|||Difference in change at week 12||0.58|-9.76|.144
74002947|NCT02647320|147554675|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|3.16||0.773|TWO_SIDED|90.0|-6.14|4.31|||Mixed Model Repeated Measure|||Difference in change at week 12||4.31|-6.14|.773
74002948|NCT02647320|147554675|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.79||0.963|TWO_SIDED|90.0|-4.73|4.48|||Mixed Model Repeated Measure|||Difference in change at week 12||4.48|-4.73|.963
74002949|NCT02647320|147554675|OTHER||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.74||0.258|TWO_SIDED|90.0|-7.64|1.42|||Mixed Model Repeated Measure|||Difference in change at week 12||1.42|-7.64|.258
74002950|NCT02647320|147554676|OTHER||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|5.5||0.228|TWO_SIDED|90.0|-15.74|2.43|||Mixed Model Repeated Measure|||Difference in change at week 12||2.43|-15.74|.228
74002951|NCT02647320|147554676|OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|5.51||0.894|TWO_SIDED|90.0|-8.36|9.84|||Mixed Model Repeated Measure|||Difference in change at week 12||9.84|-8.36|.894
74002952|NCT02647320|147554676|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|4.86||0.846|TWO_SIDED|90.0|-8.97|7.08|||Mixed Model Repeated Measure|||Difference in change at week 12||7.08|-8.97|.846
74002953|NCT02647320|147554676|OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|4.77||0.409|TWO_SIDED|90.0|-11.82|3.93|||Mixed Model Repeated Measure|||Difference in change at week 12||3.93|-11.82|.409
74002954|NCT02647320|147554677|OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|2.59||0.576|TWO_SIDED|90.0|-2.83|5.73|||Mixed Model Repeated Measure|||Difference in change at week 12||5.73|-2.83|.576
74002955|NCT02647320|147554677|OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.62||0.646|TWO_SIDED|90.0|-5.53|3.12|||Mixed Model Repeated Measure|||Difference in change at week 12||3.12|-5.53|.646
74002956|NCT02647320|147554677|OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|2.3||0.902|TWO_SIDED|90.0|-3.52|4.08|||Mixed Model Repeated Measure|||Difference in change at week 12||4.08|-3.52|.902
74002957|NCT02647320|147554677|OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.27||0.478|TWO_SIDED|90.0|-5.35|2.13|||Mixed Model Repeated Measure|||Difference in change at week 12||2.13|-5.35|.478
74002958|NCT02647320|147554678|OTHER||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|4.22||0.072|TWO_SIDED|90.0|-14.57|-0.64|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.64|-14.57|.072
74002959|NCT02647320|147554678|OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|4.26||0.794|TWO_SIDED|90.0|-8.15|5.92|||Mixed Model Repeated Measure|||Difference in change at week 12||5.92|-8.15|.794
74002960|NCT02647320|147554678|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|3.75||0.946|TWO_SIDED|90.0|-6.45|5.94|||Mixed Model Repeated Measure|||Difference in change at week 12||5.94|-6.45|.946
74002961|NCT02647320|147554678|OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|3.68||0.431|TWO_SIDED|90.0|-8.99|3.18|||Mixed Model Repeated Measure|||Difference in change at week 12||3.18|-8.99|.431
74002962|NCT02647320|147554679|OTHER||LS Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|8.54||0.228|TWO_SIDED|90.0|-24.43|3.78|||Mixed Model Repeated Measure|||Difference in change at week 12||3.78|-24.43|.228
74002963|NCT02647320|147554679|OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|8.62||0.951|TWO_SIDED|90.0|-13.7|14.77|||Mixed Model Repeated Measure|||Difference in change at week 12||14.77|-13.70|.951
74002964|NCT02647320|147554679|OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|7.59||0.852|TWO_SIDED|90.0|-13.96|11.13|||Mixed Model Repeated Measure|||Difference in change at week 12||11.13|-13.96|.852
74002965|NCT02647320|147554679|OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|7.45||0.608|TWO_SIDED|90.0|-16.13|8.48|||Mixed Model Repeated Measure|||Difference in change at week 12||8.48|-16.13|.608
74002966|NCT02647320|147554680|OTHER||LS Mean Difference|5.32|STANDARD_ERROR_OF_MEAN|15.289||0.728|TWO_SIDED|90.0|-19.932|30.566|||Mixed Model Repeated Measure|||Difference in change at week 4||30.566|-19.932|.728
74002967|NCT02647320|147554680|OTHER||LS Mean Difference|-3.27|STANDARD_ERROR_OF_MEAN|15.853||0.837|TWO_SIDED|90.0|-29.446|22.914|||Mixed Model Repeated Measure|||Difference in change at week 4||22.914|-29.446|.837
74002968|NCT02647320|147554680|OTHER||LS Mean Difference|-3.65|STANDARD_ERROR_OF_MEAN|13.747||0.791|TWO_SIDED|90.0|-26.352|19.051|||Mixed Model Repeated Measure|||Difference in change at week 4||19.051|-26.352|.791
74002969|NCT02647320|147554680|OTHER||LS Mean Difference|-40.03|STANDARD_ERROR_OF_MEAN|13.472||0.003|TWO_SIDED|90.0|-62.283|-17.787|||Mixed Model Repeated Measure|||Difference in change at week 4||-17.787|-62.283|.003
74037460|NCT00438399|147628445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||0.0003
74037461|NCT00438399|147628445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||0.007
74037462|NCT00438399|147628445|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||<0.0001
74037463|NCT02365584|147628448|SUPERIORITY|"The assumptions required for the analysis of covariance (ANCOVA) were to be tested as follows:~* The equality of variances was to verified using the Levene's test. If it was significant AUC values were to be properly transformed.~* The linear relationship of AUC with the basal total score within treatment group was to be tested by a regression analysis.~* The parallelism of the regression lines between groups and the slope non zero value with the appropriate F tests."|Adjusted LS Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|17.7|=|0.5396|TWO_SIDED|95.0|-47.0|25.0|||ANCOVA|||Analysis of covariance (ANCOVA), where the AUC was the dependent and the independent was the baseline ESAS total score.||25|-47|=0.5396
74037464|NCT02193815|147628475|SUPERIORITY_OR_OTHER||Adjusted Mean Ratio|93.2|STANDARD_ERROR_OF_MEAN|0.075||0.3465|TWO_SIDED|95.0|80.43|107.99|||Mixed Models Analysis|||||107.99|80.43|0.3465
74037465|NCT02193815|147628476|SUPERIORITY_OR_OTHER||Adjusted Mean|165.88|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|143.12|192.25|||Mixed Models Analysis|||||192.25|143.12|<0.0001
74037466|NCT02193815|147628477|SUPERIORITY_OR_OTHER||Adjusted Mean|65.42|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|56.46|75.81|||Mixed Models Analysis|||||75.81|56.46|<0.0001
74037467|NCT02193815|147628478|SUPERIORITY_OR_OTHER||Adjusted Mean|93.04|STANDARD_ERROR_OF_MEAN|0.075||0.3349|TWO_SIDED|95.0|80.3|107.81|||Mixed Models Analysis|||||107.81|80.30|0.3349
74037468|NCT02193815|147628478|SUPERIORITY_OR_OTHER||Adjusted Mean|149.56|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|129.04|173.34|||Mixed Models Analysis|||||173.34|129.04|<0.0001
74037469|NCT02193815|147628478|SUPERIORITY_OR_OTHER||Adjusted Mean|106.51|STANDARD_ERROR_OF_MEAN|0.075||0.3991|TWO_SIDED|95.0|91.92|123.41|||Mixed Models Analysis|||||123.41|91.92|0.3991
74037470|NCT02193815|147628478|SUPERIORITY_OR_OTHER||Adjusted Mean|71.94|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|62.08|83.36|||Mixed Models Analysis|||||83.36|62.08|<0.0001
74037471|NCT02193815|147628479|SUPERIORITY_OR_OTHER||Adjusted Mean|96.04|STANDARD_ERROR_OF_MEAN|0.127||0.7529|TWO_SIDED|95.0|74.0|124.64|||Mixed Models Analysis|||||124.64|74.00|0.7529
74037472|NCT02193815|147628479|SUPERIORITY_OR_OTHER||Adjusted Mean|125.62|STANDARD_ERROR_OF_MEAN|0.147||0.1318|TWO_SIDED|95.0|92.96|169.75|||Mixed Models Analysis|||||169.75|92.96|0.1318
74037473|NCT02193815|147628479|SUPERIORITY_OR_OTHER||Adjusted Mean|103.35|STANDARD_ERROR_OF_MEAN|0.129||0.8009|TWO_SIDED|95.0|79.3|134.68|||Mixed Models Analysis|||||134.68|79.30|0.8009
74037474|NCT02193815|147628479|SUPERIORITY_OR_OTHER||Adjusted Mean|81.09|STANDARD_ERROR_OF_MEAN|0.124||0.1012|TWO_SIDED|95.0|62.94|104.47|||Mixed Models Analysis|||||104.47|62.94|0.1012
74037475|NCT01927419|147628484|SUPERIORITY||Mean Difference (Final Values)|49.5|||||TWO_SIDED|95.0|31.4|61.8|||Fisher Exact||Difference of ORR||Exact 95% CI for difference in ORR uses Newcombe's method|61.8|31.4|
74037476|NCT01927419|147628484|SUPERIORITY||Odds Ratio (OR)|12.52|||||TWO_SIDED|95.0|3.79|52.55|||Fisher Exact|||||52.55|3.79|
74002970|NCT02647320|147554681|OTHER||LS Mean Difference|4.39|STANDARD_ERROR_OF_MEAN|20.396||0.83|TWO_SIDED|90.0|-29.312|38.087|||Mixed Model Repeated Measure|||Difference in change at week 12||38.087|-29.312|.830
74002971|NCT02647320|147554681|OTHER||LS Mean Difference|24.25|STANDARD_ERROR_OF_MEAN|20.335||0.235|TWO_SIDED|90.0|-9.354|57.848|||Mixed Model Repeated Measure|||Difference in change at week 12||57.848|-9.354|.235
74002972|NCT02647320|147554681|OTHER||LS Mean Difference|17.25|STANDARD_ERROR_OF_MEAN|17.72||0.331|TWO_SIDED|90.0|-12.03|46.529|||Mixed Model Repeated Measure|||Difference in change at week 12||46.529|-12.030|.331
74037477|NCT01927419|147628485|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.21|0.59|||Unstratified Cox proportional hazard||Nivolumab + Ipilimumab over Ipilimumab|||0.59|0.21|
74037478|NCT01927419|147628486|SUPERIORITY||Mean Difference (Final Values)|44.5|||||TWO_SIDED|95.0|8.2|64.8|||Fisher Exact||Difference of ORR||Exact 95% CI for difference in ORR uses Newcombe's method|64.8|8.2|
74037479|NCT01927419|147628486|SUPERIORITY||Odds Ratio (OR)|10.8|||||TWO_SIDED|95.0|1.07|511.89|||Fisher Exact|||||511.89|1.07|
74037480|NCT01927419|147628487|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.14|0.97|||Unstratified Cox proportional hazard||Nivolumab + Ipilimumab over Ipilimumab|||0.97|0.14|
74037481|NCT01511107|147628538|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.172|STANDARD_DEVIATION|0.039|||TWO_SIDED|95.0|-0.253|-0.091||||||The null hypothesis that amoxicillin-clavulanate 5 days, placebo 5 days (reduced duration) is inferior to amoxicillin-clavulanate 10 days (standard duration) is tested against the alternative that reduced duration treatment is noninferior. Assuming failure rates of 15% and 25% in the standard and reduced duration groups, respectively, a 2-sided significance level of .05 and 10% attrition, it was calculated that 300 participants per group, would provide power of 95% for finding inferiority.||-.091|-.253|
74037482|NCT01511107|147628539|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.096|STANDARD_DEVIATION|0.053|||TWO_SIDED|95.0|-0.209|0.016||||||||.016|-.209|
74037483|NCT01511107|147628540|SUPERIORITY_OR_OTHER|||||||0.45|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are negative for AOM pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.45
74037484|NCT01511107|147628541|SUPERIORITY_OR_OTHER|||||||0.95|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is negative for AOM pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||0.95
74037485|NCT01511107|147628542|SUPERIORITY_OR_OTHER|||||||0.59|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive only for one or more susceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.59
74037486|NCT01511107|147628543|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive only for one or more susceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||>0.99
74037487|NCT01511107|147628544|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive for one or more nonsusceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.47
74037488|NCT01511107|147628545|SUPERIORITY_OR_OTHER|||||||0.05|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive for one or more nonsusceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||0.05
74037489|NCT01511107|147628546|SUPERIORITY_OR_OTHER|||||||0.58|||||||Regression, Logistic|The p-value is adjusted for the culture result at enrollment.||Null hypothesis: There is no difference in the proportion of subjects whose NP isolates at enrollment are pathogen-negative or positive only for at least one susceptible pathogen who become colonized with penicillin non-susceptible pathogens at any time over the course of follow-up||||0.58
74090923|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|1.01|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-1.7|3.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-1.7|
74090924|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|1.26|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-1.4|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-1.4|
73877921|NCT03084796|147295442|SUPERIORITY||Mean Difference (Final Values)|0.082|||<|0.001|TWO_SIDED|95.0|0.045|0.118|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.118|0.045|<0.001
74037490|NCT01511107|147628547|SUPERIORITY_OR_OTHER|||||||0.74|||||||Generalized estimating equations|||Null hypothesis: There is no difference in the proportion of 6 week follow-up, non-illness visits at which a penicillin-nonsusceptible pathogen is recovered.||||0.74
74037491|NCT01511107|147628548|SUPERIORITY_OR_OTHER|||||||0.72|||||||Regression, Logistic|The p-value is adjusted for S pn susceptibility at the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible S pn isolate.||||0.72
74037492|NCT01511107|147628549|SUPERIORITY_OR_OTHER|||||||0.05|||||||Generalized estimating equations|The p-value is adjusted for S pn susceptibility at onset of the AOM recurrence.||||||0.05
74037493|NCT01511107|147628550|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Logistic|The p-value is adjusted for H flu susceptibility at onset of the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible H flu isolate.||||0.47
74037494|NCT01511107|147628551|SUPERIORITY_OR_OTHER|||||||0.69|||||||Generalized estimating equations|The p-value is adjusted for H flu susceptibility at onset of the AOM recurrence.||||||0.69
74037495|NCT01511107|147628552|SUPERIORITY_OR_OTHER|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children followed greater than 60 days having at least one AOM relapse or recurrence within 60 days of enrollment.||||0.16
74037496|NCT01511107|147628553|SUPERIORITY_OR_OTHER|||||||0.32|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children completing the study having at least one AOM relapse or recurrence within the entire respiratory season.||||0.32
74037497|NCT01511107|147628554|SUPERIORITY_OR_OTHER|||||||0.23|||||||Regression, Poisson|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within 60 days of enrollment.||||0.23
74037498|NCT01511107|147628555|SUPERIORITY_OR_OTHER|||||||0.22|||||||Regression, Poisson|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within the entire respiratory season.||||0.22
74037499|NCT01511107|147628556|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|The p-value is adjusted for site \& the stratification variables and for length of follow-up.||Null hypothesis: There is no difference between the two groups in the mean number of days a systemic antibiotic was received during the respiratory season.||||<.001
74037500|NCT01511107|147628557|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for site \& the stratification variables, episode, day of the diary and AOM-SOS score at the episode.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.||||0.07
74037501|NCT01511107|147628558|SUPERIORITY_OR_OTHER|||||||0.7|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom PDD was reported.||||0.70
74037502|NCT01511107|147628559|SUPERIORITY_OR_OTHER|||||||0.86|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom diaper dermatitis was reported.||||0.86
74037503|NCT03342937|147628560|SUPERIORITY|1-sided test of single exponential mean with historical null hypothesis of 5.5 months median PFS||||||0.02||||||Sample size of 35 patients was chosen based on detecting the difference between a historical median PFS of 5.5 months and experimental median of 7.3 months, a hazard ratio of 0.75, with 80% power (1-sided test of single exponential mean, α=0.2).|1-sided exponential test|||||||0.02
74037504|NCT02928380|147628591|OTHER||Least square (LS) mean difference|-0.02||||0.0987|TWO_SIDED|95.0|-0.05|0.0|||ANOVA|ANOVA Model with weight of the peanut particle (food occlusion) as response variable, treatment and period as fixed effect.|Difference is first named treatment minus second named treatment is such that a negative difference favors the first named treatment.|H0: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is no different from using no adhesive H01: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is different from using no adhesive.||0.00|-0.05|0.0987
74037505|NCT03115112|147628682|NON_INFERIORITY|The non-inferiority margin of 0.35% was determined based on a reference clinical trial that demonstrated the effectiveness of sitagliptin, 100 mg, compared to placebo on HbA1c reduction in subjects with type 2 DM. A margin of 0.35% was selected to be approximately half of sitagliptin effect and remained clinically meaningful.|Difference of LS Means|0.08|||||TWO_SIDED|95.0|-0.07|0.22|||||Mixed-effects repeated measures analysis includes region, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as fixed effect covariates.|||0.22|-0.07|
74037506|NCT03115112|147628683|SUPERIORITY||Difference of LS Means|-0.37||||0.0123|TWO_SIDED|95.0|-0.7|-0.05|||Mixed-effects repeated measures|Covariate includes region, treatment, visit, treatment-by-visit interaction and the baseline FPG value as a fixed effect covariate.||||-0.05|-0.70|0.0123
74037507|NCT03115112|147628684|SUPERIORITY||Difference of LS Means|-2.54|||<|0.0001|TWO_SIDED|95.0|-3.15|-1.92|||Mixed-effects repeated measures|Included region, treatment, visit, treatment-by-visit interaction and the baseline body weight value as fixed effect covariate.||||-1.92|-3.15|<0.0001
74037508|NCT03115112|147628685|SUPERIORITY||mixed-effects repeated measures|-2.33||||0.0276|TWO_SIDED|95.0|-4.7|0.05|||t-test, 1 sided|p value was presented based on one sided statistical tests using a 0.025 level of significance|Included region, treatment, visit, treatment-by-visit interaction and the baseline body weight value as fixed effect covariate.|||0.05|-4.70|0.0276
74037509|NCT01546285|147628686|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-1.4|STANDARD_DEVIATION|4.8|||TWO_SIDED|95.0|-2.58|-0.22|||Compare the mean difference with 5mmHg|||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4 mmHg and a standard deviation of no more than 5 mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is at least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in systolic, diastolic, and mean BP determinations will be compared. A difference of within 10 mmHg is considered equivalent in NIBP.||-0.22|-2.58|
74037510|NCT01546285|147628686|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.3|STANDARD_DEVIATION|2.6|||TWO_SIDED|95.0|-3.95|-2.66||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.||-2.66|-3.95|
74039827|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.01|-0.39|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.39|-1.01|<.0001
74039828|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.15||0.0361|TWO_SIDED|95.0|-0.59|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.59|0.0361
74090925|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.0|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-2.0|
74037511|NCT01546285|147628686|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.7|STANDARD_DEVIATION|4.2|||TWO_SIDED|95.0|-4.73|-2.67||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.||-2.67|-4.73|
74037512|NCT01205451|147628694|SUPERIORITY_OR_OTHER||t-distribution|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.38|-1.04||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-1.04|-1.38|<0.0001
74037513|NCT01205451|147628694|SUPERIORITY_OR_OTHER||t-distribution|-1.33|||<|0.0001|TWO_SIDED|95.0|-1.54|-1.12||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-1.12|-1.54|<0.0001
74037514|NCT01205451|147628694|SUPERIORITY_OR_OTHER||t-distribution|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.04|-0.72||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-0.72|-1.04|<0.0001
74037515|NCT01205451|147628694|SUPERIORITY_OR_OTHER||t-distribution|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.91||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-0.91|-1.33|<0.0001
74037516|NCT01170702|147628713|NON_INFERIORITY|The non inferiority margin is clinically important reduction in 24 hour hydromorphone consumption of 25%, 37.5% and 50% absolute reduction, compared with control.|Median Difference (Final Values)|1.25|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|0.975|1.25|1.25|||Kruskal-Wallis|||||1.25|1.25|.05
74037517|NCT01677507|147628721|OTHER||Mean Difference (Final Values)|2.8||||0.0001|TWO_SIDED|95.0|2.4|3.3|||t-test, 2 sided|Actually these are 2 sided paired t-tests.||Right Eye treated vs. untreated||3.3|2.4|0.0001
74090926|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|0.36|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.3|3.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.0|-2.3|
74090927|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-4.3|1.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-4.3|
73877922|NCT03084796|147295442|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.008|TWO_SIDED|95.0|0.013|0.086|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.086|0.013|0.008
74037518|NCT01677507|147628721|OTHER||Mean Difference (Final Values)|2.8||||0.0001|TWO_SIDED|95.0|2.5|3.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye treated vs. untreated||3.2|2.5|0.0001
74037519|NCT01677507|147628721|OTHER||Mean Difference (Final Values)|3.0||||0.0001|TWO_SIDED|95.0|2.5|3.4|||t-test, 2 sided|paired t-test, 2 sided||Right Eye treated vs. untreated||3.4|2.5|0.0001
74037520|NCT01677507|147628721|OTHER||Mean Difference (Final Values)|2.9||||0.0001|TWO_SIDED|95.0|2.5|3.3|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||3.3|2.5|0.0001
74037521|NCT01677507|147628722|OTHER||Median Difference (Final Values)|1.1||||0.0001|TWO_SIDED|95.0|0.9|1.3|||t-test, 2 sided|paired t test, 2 sided||Right Eye treated to untreated||1.3|0.9|0.0001
74037522|NCT01677507|147628722|OTHER||Median Difference (Final Values)|0.9||||0.0001|TWO_SIDED|95.0|0.7|1.1|||t-test, 2 sided|paired t test, 2 sided||Left Eye, treated vs. untreated||1.1|0.7|0.0001
74037523|NCT01677507|147628722|OTHER||Mean Difference (Final Values)|0.01||||0.94|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|paired t-test||Right Eye, treated vs. untreated||0.2|-0.2|0.94
74037524|NCT01677507|147628722|OTHER||Mean Difference (Final Values)|0.05||||0.54|TWO_SIDED|95.0|-0.1|0.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||0.2|-0.1|0.54
74037525|NCT01677507|147628723|OTHER||Mean Difference (Final Values)|0.4||||0.04|TWO_SIDED|95.0|0.01|0.7|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated||0.7|0.01|0.04
74037526|NCT01677507|147628723|OTHER||Mean Difference (Final Values)|0.2||||0.15|TWO_SIDED|95.0|-0.1|0.6|||t-test, 2 sided|paired t-test, 2 sided||Left eye, treated vs. untreated||0.6|-0.1|0.15
74037527|NCT01677507|147628723|OTHER||Mean Difference (Final Values)|0.1||||0.52|TWO_SIDED|95.0|-0.3|0.6|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated||0.6|-0.3|0.52
74037528|NCT01677507|147628723|OTHER||Mean Difference (Final Values)|0.03||||0.88|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||0.4|-0.4|0.88
74090928|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.51|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-4.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-4.2|
74037529|NCT00664755|147628724|SUPERIORITY||Odds Ratio (OR)|2.77||||0.011|TWO_SIDED|95.0|1.17|6.59|||Regression, Logistic|||||6.59|1.17|0.011
74037530|NCT03084718|147628778|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.567|TWO_SIDED|95.0|-0.052|0.14|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.140|-0.052|0.567
74037531|NCT03084718|147628778|SUPERIORITY||Mean Difference (Final Values)|0.113||||0.015|TWO_SIDED|95.0|0.018|0.209|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.209|0.018|0.015
74037532|NCT03084718|147628778|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.059|TWO_SIDED|95.0|-0.003|0.188|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.188|-0.003|0.059
74090929|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.83|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-3.5|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-3.5|
74090930|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-4.2|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.0|-4.2|
73877923|NCT03084796|147295442|SUPERIORITY||Mean Difference (Final Values)|0.063|||<|0.001|TWO_SIDED|95.0|0.027|0.1|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.100|0.027|<0.001
74037533|NCT03084718|147628778|SUPERIORITY||Mean Difference (Final Values)|0.069||||0.09|TWO_SIDED|95.0|-0.011|0.15|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.150|-0.011|0.090
74037534|NCT03084718|147628778|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.231|TWO_SIDED|95.0|-0.031|0.129|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.129|-0.031|0.231
74037535|NCT03084718|147628778|SUPERIORITY||Mean Difference (Final Values)|-0.021||||0.612|TWO_SIDED|95.0|-0.101|0.059|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.059|-0.101|0.612
74037536|NCT03084718|147628778|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.011|TWO_SIDED|95.0|0.023|0.18|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.180|0.023|0.011
74037537|NCT03084718|147628779|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.647|TWO_SIDED|95.0|-0.06|0.097|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.097|-0.060|0.647
74037538|NCT03084718|147628779|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.004|TWO_SIDED|95.0|0.039|0.196|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.196|0.039|0.004
74037539|NCT03084718|147628779|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.076|TWO_SIDED|95.0|-0.008|0.149|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.149|-0.008|0.076
74037540|NCT03084718|147628779|SUPERIORITY||Mean Difference (Final Values)|0.099||||0.014|TWO_SIDED|95.0|0.02|0.179|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.179|0.020|0.014
74037541|NCT03084718|147628779|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.192|TWO_SIDED|95.0|-0.026|0.131|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.131|-0.026|0.192
74037542|NCT03084718|147628779|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.244|TWO_SIDED|95.0|-0.126|0.032|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.032|-0.126|0.244
74037543|NCT03084718|147628779|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.06|TWO_SIDED|95.0|-0.003|0.151|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.151|-0.003|0.060
74037544|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.012||||0.78|TWO_SIDED|95.0|-0.074|0.098|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.098|-0.074|0.780
74037545|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.086|TWO_SIDED|95.0|-0.011|0.162|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.162|-0.011|0.086
74037546|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.324|TWO_SIDED|95.0|-0.043|0.129|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.129|-0.043|0.324
74037547|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.153|TWO_SIDED|95.0|-0.024|0.15|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.150|-0.024|0.153
74037548|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.482|TWO_SIDED|95.0|-0.055|0.117|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.117|-0.055|0.482
74037549|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.463|TWO_SIDED|95.0|-0.119|0.054|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.054|-0.119|0.463
74037550|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.032||||0.453|TWO_SIDED|95.0|-0.052|0.117|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.117|-0.052|0.453
74090931|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|1.07|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-1.5|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-1.5|
74037551|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.533|TWO_SIDED|95.0|-0.064|0.123|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.123|-0.064|0.533
74037552|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.105||||0.029|TWO_SIDED|95.0|0.011|0.199|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.199|0.011|0.029
74037553|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.274|TWO_SIDED|95.0|-0.041|0.146|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.146|-0.041|0.274
74037554|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.119|TWO_SIDED|95.0|-0.019|0.169|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.169|-0.019|0.119
74037555|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.638|TWO_SIDED|95.0|-0.071|0.116|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.116|-0.071|0.638
74037556|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|-0.052||||0.274|TWO_SIDED|95.0|-0.147|0.042|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.042|-0.147|0.274
74037557|NCT03084718|147628780|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.092|TWO_SIDED|95.0|-0.013|0.171|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.171|-0.013|0.092
74037558|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.053|TWO_SIDED|95.0|-0.31|0.0|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.00|-0.31|0.053
74037559|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.001|TWO_SIDED|95.0|-0.42|-0.11|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.11|-0.42|0.001
74037560|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.006|TWO_SIDED|95.0|-0.37|-0.06|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.06|-0.37|0.006
74037561|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.176|TWO_SIDED|95.0|-0.26|0.05|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.05|-0.26|0.176
74037562|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.423|TWO_SIDED|95.0|-0.22|0.09|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.09|-0.22|0.423
74037563|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.574|TWO_SIDED|95.0|-0.11|0.2|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.20|-0.11|0.574
74037564|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.011|TWO_SIDED|95.0|-0.35|-0.05|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.05|-0.35|0.011
74037565|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.215|TWO_SIDED|95.0|-0.27|0.06|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo"||0.06|-0.27|0.215
74090932|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|0.82|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-1.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-1.8|
74090933|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.32|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-3.9|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.9|
74090934|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|0.56|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-2.0|3.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.2|-2.0|
74090935|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-2.6|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.6|
74090936|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.05|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-4.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-4.7|
74090937|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-2.2|3.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.0|-2.2|
74090938|NCT02037165|147735938|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.26|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-2.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-2.9|
74090939|NCT02037165|147735939|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.2419|||TWO_SIDED|95.0|-3.4|1.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-3.4|
74090940|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-4.4|0.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.5|-4.4|
74002973|NCT02647320|147554681|OTHER||LS Mean Difference|-29.51|STANDARD_ERROR_OF_MEAN|17.393||0.091|TWO_SIDED|90.0|-58.254|-0.775|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.775|-58.254|.091
74002974|NCT02647320|147554682|OTHER||LS Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|9.28||0.873|TWO_SIDED|90.0|-13.835|16.815|||Mixed Model Repeated Measure|||Difference in change at week 4||16.815|-13.835|.873
74002975|NCT02647320|147554682|OTHER||LS Mean Difference|-8.09|STANDARD_ERROR_OF_MEAN|9.505||0.395|TWO_SIDED|90.0|-23.79|7.604|||Mixed Model Repeated Measure|||Difference in change at week 4||7.604|-23.790|.395
74002976|NCT02647320|147554682|OTHER||LS Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|8.306||0.761|TWO_SIDED|90.0|-16.247|11.185|||Mixed Model Repeated Measure|||Difference in change at week 4||11.185|-16.247|.761
74002977|NCT02647320|147554682|OTHER||LS Mean Difference|-27.73|STANDARD_ERROR_OF_MEAN|8.17|<|0.001|TWO_SIDED|90.0|-41.22|-14.236|||Mixed Model Repeated Measure|||Difference in change at week 4||-14.236|-41.220|<0.001
74002978|NCT02647320|147554683|OTHER||LS Mean Difference|-7.61|STANDARD_ERROR_OF_MEAN|12.001||0.527|TWO_SIDED|90.0|-27.441|12.221|||Mixed Model Repeated Measure|||Difference in change at week 12||12.221|-27.441|.527
74002979|NCT02647320|147554683|OTHER||LS Mean Difference|-7.39|STANDARD_ERROR_OF_MEAN|0.532||0.532|TWO_SIDED|90.0|-26.927|12.138|||Mixed Model Repeated Measure|||Difference in change at week 12||12.138|-26.927|.532
74002980|NCT02647320|147554683|OTHER||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|10.421||0.672|TWO_SIDED|90.0|-21.635|12.807|||Mixed Model Repeated Measure|||Difference in change at week 12||12.807|-21.635|.672
74002981|NCT02647320|147554683|OTHER||LS Mean Difference|-31.58|STANDARD_ERROR_OF_MEAN|10.229||0.002|TWO_SIDED|90.0|-48.482|-14.676|||Mixed Model Repeated Measure|||Difference in change at week 12||-14.676|-48.482|.002
74002982|NCT02647320|147554684|OTHER||LS Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|5.9||0.298|TWO_SIDED|90.0|-15.9|3.6|||Mixed Model Repeated Measure|||Difference in change at week 2||3.60|-15.90|.298
74002983|NCT02647320|147554684|OTHER||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|6.09||0.008|TWO_SIDED|90.0|-26.37|-6.27|||Mixed Model Repeated Measure|||Difference in change at week 2||-6.27|-26.37|.008
74002984|NCT02647320|147554684|OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.32||0.074|TWO_SIDED|90.0|-18.31|-0.75|||Mixed Model Repeated Measure|||Difference in change at week 2||-0.75|-18.31|.074
74002985|NCT02647320|147554684|OTHER||LS Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|5.32|<|0.001|TWO_SIDED|90.0|-35.96|-18.38|||Mixed Model Repeated Measure|||Difference in change at week 2||-18.38|-35.96|<0.001
74002986|NCT02647320|147554685|OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|5.96||0.84|TWO_SIDED|90.0|-11.04|8.63|||Mixed Model Repeated Measure|||Difference in change at week 4||8.63|-11.04|.840
74002987|NCT02647320|147554685|OTHER||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|6.06||0.05|TWO_SIDED|90.0|-21.94|-1.91|||Mixed Model Repeated Measure|||Difference in change at week 4||-1.91|-21.94|.050
74002988|NCT02647320|147554685|OTHER||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|5.31||0.227|TWO_SIDED|90.0|-15.21|2.33|||Mixed Model Repeated Measure|||Difference in change at week 4||2.33|-15.21|.227
74037566|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.07|TWO_SIDED|95.0|-0.32|0.01|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.01|-0.32|0.070
74002989|NCT02647320|147554685|OTHER||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|5.27||0.13|TWO_SIDED|90.0|-21.83|-4.43|||Mixed Model Repeated Measure|||Difference in change at week 4||-4.43|-21.83|0.13
74002990|NCT02647320|147554686|OTHER||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|6.55||0.642|TWO_SIDED|90.0|-7.77|13.88|||Mixed Model Repeated Measure|||Difference in change at week 8||13.88|-7.77|.642
74002991|NCT02647320|147554686|OTHER||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|6.72||0.512|TWO_SIDED|90.0|-15.52|6.68|||Mixed Model Repeated Measure|||Difference in change at week 8||6.68|-15.52|.512
74002992|NCT02647320|147554686|OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|5.81||0.486|TWO_SIDED|90.0|-13.66|5.54|||Mixed Model Repeated Measure|||Difference in change at week 8||5.54|-13.66|.486
74002993|NCT02647320|147554686|OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|5.8||0.004|TWO_SIDED|90.0|-26.31|-7.16|||Mixed Model Repeated Measure|||Difference in change at week 8||-7.16|-26.31|.004
74002994|NCT02647320|147554687|OTHER||LS Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|8.11||0.285|TWO_SIDED|90.0|-22.09|4.7|||Mixed Model Repeated Measure|||Difference in change at week 12||4.70|-22.09|.285
74002995|NCT02647320|147554687|OTHER||LS Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|7.94||0.02|TWO_SIDED|90.0|-31.73|-5.49|||Mixed Model Repeated Measure|||Difference in change at week 12||-5.49|-31.73|.020
74002996|NCT02647320|147554687|OTHER||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|7.03||0.067|TWO_SIDED|90.0|-24.6|-1.35|||Mixed Model Repeated Measure|||Difference in change at week 12||-1.35|-24.60|.067
74002997|NCT02647320|147554687|OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|6.88||0.012|TWO_SIDED|90.0|-28.76|-6.03|||Mixed Model Repeated Measure|||Difference in change at week 12||-6.03|-28.76|.012
74002998|NCT00596427|147554702|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||Change from baseline between groups were compared.||||<0.01
74002999|NCT00596427|147554703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||mixed-effects regression models|||Change from baseline between groups was compared.||||<0.001
74003000|NCT00596427|147554704|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|This model had fixed effects of treatment, visit and treatment by visit interaction and a random subject effect.||Comparison of change from baseline between groups (treatment effect)||||<0.1
74003001|NCT00596427|147554705|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||||||<0.01
74003002|NCT00596427|147554706|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||mixed-effects regression models|||||||<0.05
74003003|NCT00596427|147554707|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|||Change from baseline between groups were compared (treatment effect)||||<0.1
74003004|NCT00596427|147554708|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||mixed-effects regression models|||||||0.05
74003005|NCT00596427|147554709|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||mixed-effects regression models|||||||0.6
74003006|NCT00596427|147554710|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||0.3
74037567|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.005|TWO_SIDED|95.0|-0.4|-0.07|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.07|-0.40|0.005
74037568|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.566|TWO_SIDED|95.0|-0.21|0.12|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.12|-0.21|0.566
74003007|NCT00596427|147554711|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||<0.0001
74003008|NCT00596427|147554712|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||<0.01
74003009|NCT00596427|147554713|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|||||||<0.1
74003010|NCT00320541|147554714|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance at 0.05 level was required.|Fisher Exact|||Assuming the response rate for the PB arm is 34% and the addition of gemcitabine will improve it to 54%, then a sample size of 170 evaluable participants (85 per arm) will give an 80% statistical power to detect the difference, using a 1-sided test at the significance level of 0.05. Confidence levels are exact binomial 95% Confidence Intervals.||||0.117
74003011|NCT00320541|147554715|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Log Rank|||||||0.247
74003012|NCT00320541|147554716|SUPERIORITY_OR_OTHER|||||||0.475||95.0|||||Log Rank|||||||0.475
74003013|NCT00320541|147554717|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.010
74003014|NCT00320541|147554718|SUPERIORITY_OR_OTHER|||||||0.119||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.119
74003015|NCT00320541|147554719|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.023
74003016|NCT00320541|147554720|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.002
74003017|NCT00320541|147554721|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.004
74003018|NCT00320541|147554722|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.067
74003019|NCT00320541|147554723|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.036
74003020|NCT01605292|147554724|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
74003021|NCT01605292|147554725|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||||||0.006
74003022|NCT01605292|147554726|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
74003023|NCT01605292|147554727|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Fisher Exact|||||||0.56
74003024|NCT01605292|147554728|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
74003025|NCT01605292|147554729|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Chi-squared|||||||0.07
74003026|NCT01605292|147554730|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher Exact|||||||0.75
74003027|NCT01605292|147554732|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|||||||0.007
74003028|NCT03057977|147554734|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.75|||<|0.0001|TWO_SIDED|95.04|0.65|0.86|||Regression, Cox||Comparison vs. Placebo \[T/P\]|"Model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.~alpha = 0.0496 (resulting from interim analysis) eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction."||0.86|0.65|<0.0001
74003029|NCT03057977|147554735|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.04|0.58|0.85|||Joint frailty model||HR vs placebo of recurrent HFF|"Model accounts for dependence between recurrent HHF and cardiovascular death, with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.~eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction."||0.85|0.58|0.0003
74037569|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.124|TWO_SIDED|95.0|-0.29|0.04|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.04|-0.29|0.124
74037570|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.336|TWO_SIDED|95.0|-0.25|0.08|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.08|-0.25|0.336
74037571|NCT03084718|147628781|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.01|TWO_SIDED|95.0|-0.37|-0.05|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.05|-0.37|0.010
74037572|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.067|TWO_SIDED|95.0|-0.38|0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.01|-0.38|0.067
74037573|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.53|-0.14|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.14|-0.53|< 0.001
74037574|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.038|TWO_SIDED|95.0|-0.4|-0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.01|-0.40|0.038
74037575|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.13|TWO_SIDED|95.0|-0.35|0.05|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.05|-0.35|0.130
74037576|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.811|TWO_SIDED|95.0|-0.22|0.17|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.17|-0.22|0.811
74037577|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.202|TWO_SIDED|95.0|-0.07|0.33|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.33|-0.07|0.202
74037578|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.044|TWO_SIDED|95.0|-0.39|-0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.01|-0.39|0.044
73877924|NCT03084796|147295442|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.443|TWO_SIDED|95.0|-0.022|0.051|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.051|-0.022|0.443
74090941|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-4.1|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-4.1|
74090942|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-3.0|
74090943|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.1|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-2.1|
73877925|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.072|||<|0.001|TWO_SIDED|95.0|0.038|0.105|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.105|0.038|<0.001
73877926|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.086|||<|0.001|TWO_SIDED|95.0|0.052|0.119|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.119|0.052|<0.001
74090944|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.1|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-2.1|
73877927|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.143|||<|0.001|TWO_SIDED|95.0|0.109|0.177|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.177|0.109|<0.001
73877928|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.127|0.194|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.194|0.127|<0.001
74003030|NCT03057977|147554736|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Treatment by time interaction|1.733|||<|0.0001|TWO_SIDED|99.9|0.669|2.796|||Random intercept random coef. model||Empa vs Placebo slope \[/year\]|"Random coefficient model allowing for random intercept and random slope per patient, with the same factors used for the primary endpoint (age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment) and additional factors time, treatment-by-time interaction, and baseline eGFR (CKD-EPI)cr-by-time interaction. Only on-treatment data from treated patients were used.~alpha=0.001"||2.796|0.669|<0.0001
74003031|NCT03057977|147554737|OTHER||Hazard Ratio (HR)|0.5||||0.0019|TWO_SIDED|95.0|0.32|0.77|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.|Comparison vs. Placebo|||0.77|0.32|0.0019
74003032|NCT03057977|147554738|OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.81|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.|Comparison vs Placebo|||0.81|0.59|<0.0001
74003033|NCT03057977|147554739|OTHER||Hazard Ratio (HR)|0.92||||0.4133|TWO_SIDED|95.0|0.75|1.12|||Regression, Cox|Model with terms for age, baseline eGFR (CKD-EPI), region, baseline diabetes status, sex, baseline LVEF and treatment.|Comparison vs. Placebo|||1.12|0.75|0.4133
74003034|NCT03057977|147554740|OTHER||Hazard Ratio (HR)|0.92||||0.3536|TWO_SIDED|95.0|0.77|1.1|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPI), region, baseline diabetes status, sex, baseline LVEF and treatment.|Comparison vs. placebo|||1.10|0.77|0.3536
74003035|NCT03057977|147554741|OTHER||Hazard Ratio (HR)|0.86||||0.3576|TWO_SIDED|95.0|0.62|1.19|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CDK-EPI), region, sex, baseline LVEF and treatment.|Comparison vs. placebo|||1.19|0.62|0.3576
73877929|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.164|||<|0.001|TWO_SIDED|95.0|0.131|0.198|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.198|0.131|<0.001
73877930|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.418|TWO_SIDED|95.0|-0.02|0.048|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.048|-0.020|0.418
74003036|NCT03057977|147554742|OTHER||Difference of adjusted means|2.06|STANDARD_ERROR_OF_MEAN|0.97||0.034|TWO_SIDED|95.0|0.16|3.96|||Mixed Model|Mixed model for repeated measures (MMRM)|Comparison vs. placebo|Mixed model with age, baseline eGFR (CKD-EPI) as linear covariate(s) and region, baseline diabetes status, sex, baseline LVEF, week reachable, treatment by visit interaction, baseline KCCQ - Clinical Summary Score by Visit interaction as fixed effects. An unstructured covariance structure has been used.||3.96|0.16|0.0340
73877931|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.071|||<|0.001|TWO_SIDED|95.0|0.038|0.105|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.105|0.038|<0.001
74003037|NCT03057977|147554743|OTHER||Hazard Ratio (HR)|0.85||||0.0065|TWO_SIDED|95.0|0.75|0.95|||Joint frailty model||Comparison vs. placebo|Joint frailty model with terms for age, baseline eGFR (CDK-EPI), region, sex, baseline diabetes status and baseline LVEF. Model accounts for dependence between recurrent all-cause hospitalizations and all-cause mortality.||0.95|0.75|0.0065
74008828|NCT00713817|147567997|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.557||||0.603|TWO_SIDED|95.0|0.293|8.261|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated the parent Randomised Controlled Trials (RCTs). The interaction between treatment group and parent RCTs was investigated, but was dropped from the model if found to have little influence. The test was performed at the 10% significance level. The final model was then treatment group and parent RCTs, i.e. the treatment effect was adjusted for parent RCTs baseline.||8.261|0.293|0.603
74008829|NCT04415658|147568004|SUPERIORITY||Risk Ratio (RR)|1.01||||0.57|TWO_SIDED|95.0|0.97|1.07|||Chi-squared, Corrected|||80% power to detect a 10% increase in hearts transplanted||1.07|0.97|0.57
74008830|NCT04415658|147568005|NON_INFERIORITY|Six percent margin, assuming 96% graft survival in control group|Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|-2.3|6.0|||Regression, Logistic|||Non-inferiority analysis for thyroxine vs saline||6.0|-2.3|<0.001
74008831|NCT05368961|147568071|OTHER|Null hypothesis; there is no difference in anxiety scores between usual care and distraction||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
74008832|NCT00791258|147568087|SUPERIORITY_OR_OTHER||Percentage|75.8|||||TWO_SIDED|95.0|73.0|78.5||||||||78.5|73.0|
74008833|NCT00791258|147568088|SUPERIORITY_OR_OTHER||Percentage|84.3|||||TWO_SIDED|95.0|81.8|86.5||||||||86.5|81.8|
74008834|NCT00791258|147568089|SUPERIORITY_OR_OTHER||Percentage|71.3|||||TWO_SIDED|95.0|68.3|74.1||||||12 week analysis||74.1|68.3|
74008835|NCT00791258|147568089|SUPERIORITY_OR_OTHER||Percentage|84.8|||||TWO_SIDED|95.0|82.4|87.0||||||20 week analysis||87.0|82.4|
74008836|NCT00791258|147568090|SUPERIORITY_OR_OTHER||Median Difference (Net)|-14.6|||<|0.0001|TWO_SIDED|95.0|-15.4|-13.8|||t-test, 1 sided|||4 week analysis||-13.8|-15.4|<0.0001
74008837|NCT00791258|147568090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.6|||<|0.0001|TWO_SIDED|95.0|-17.7|-15.7|||t-test, 1 sided|||8 week analysis||-15.7|-17.7|<0.0001
74008838|NCT00791258|147568090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.8|||<|0.0001|TWO_SIDED|95.0|-22.7|-20.9|||t-test, 1 sided|||12 week analysis||-20.9|-22.7|<0.0001
74008839|NCT00791258|147568090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.0|||<|0.0001|TWO_SIDED|95.0|-27.0|-25.0|||t-test, 1 sided|||16 week analysis||-25.0|-27.0|<0.0001
74008840|NCT00791258|147568090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.8|||<|0.0001|TWO_SIDED|95.0|-27.8|-25.7|||t-test, 1 sided|||20 week analysis||-25.7|-27.8|<0.0001
74008841|NCT00791258|147568091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.1|||<|0.0001|TWO_SIDED|95.0|-8.6|-7.6|||t-test, 1 sided|||4 week analysis||-7.6|-8.6|<0.0001
74008842|NCT00791258|147568091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.1|||<|0.0001|TWO_SIDED|95.0|-9.7|-8.5|||t-test, 1 sided|||8 week analysis||-8.5|-9.7|<0.0001
74008843|NCT00791258|147568091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.9|||<|0.0001|TWO_SIDED|95.0|-12.5|-11.4|||t-test, 1 sided|||12 week analysis||-11.4|-12.5|<0.0001
74008844|NCT00791258|147568091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.6|||<|0.0001|TWO_SIDED|95.0|-15.2|-14.0|||t-test, 1 sided|||16 week analysis||-14.0|-15.2|<0.0001
74008845|NCT00791258|147568091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.5||||0.0001|TWO_SIDED|95.0|-15.1|-13.8|||t-test, 1 sided|||20 week analysis||-13.8|-15.1|0.0001
74008846|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.8|||<|0.0001|TWO_SIDED|95.0|-16.2|-13.4|||t-test, 1 sided|||Mean 24-hour systolic blood pressure||-13.4|-16.2|<0.0001
74008847|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.3|||<|0.0001|TWO_SIDED|95.0|-17.8|-14.8|||t-test, 1 sided|||Mean daytime systolic blood pressure||-14.8|-17.8|<0.0001
74008848|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.5|||<|0.0001|TWO_SIDED|95.0|-14.1|-10.8|||t-test, 1 sided|||Mean nighttime systolic blood pressure||-10.8|-14.1|<0.0001
74008849|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6|||<|0.0001|TWO_SIDED|95.0|-15.7|-11.6|||t-test, 1 sided|||systolic blood pressure during last 2 hours of dose||-11.6|-15.7|<0.0001
74008850|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.0|||<|0.0001|TWO_SIDED|95.0|-14.7|-11.2|||t-test, 1 sided|||systolic blood pressure during last 4 hours of dose||-11.2|-14.7|<0.0001
74008851|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.6|||<|0.0001|TWO_SIDED|95.0|-14.3|-10.9|||t-test, 1 sided|||systolic blood pressure during last 6 hours of dose||-10.9|-14.3|<0.0001
74008852|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.4|||<|0.0001||95.0|-10.3|-8.5|||t-test, 1 sided|||Mean 24-hour diastolic blood pressure||-8.5|-10.3|<0.0001
73877932|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.089|||<|0.001|TWO_SIDED|95.0|0.055|0.122|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.122|0.055|<0.001
74003038|NCT02401867|147554744|NON_INFERIORITY_OR_EQUIVALENCE|We selected our initial sample size of 150 participants to detect a clinically meaningful % discordance between the two sampling approaches and achieve 90% power at the 0.05 alpha-level using McNemar's test adjusted for analysis of clustered matched-pair data.||||||0.29||||||Statistical significance was determined at an a priori threshold of p \<0.05|McNemar|Degrees of freedom = 1||Comparing the concordance of the HPV DNA-positive results to the cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data. Null hypothesis: The sensitivities between swab 1 (self-vaginal) and swab 2 (provider-cervical) are equal \[ H0 : p1 = p2 \]||||.29
74003039|NCT02401867|147554744|SUPERIORITY_OR_OTHER||Kappa|0.75|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.58|0.92||A priori threshold: p\<0.05|Kappa||Using the asymptotic standard error assuming the null hypothesis.|Concordance of HPV DNA detection between self-swab and provider swab assessed via an unweighted Kappa (K) statistic to determine the percentage agreement beyond that expected by chance.||0.92|0.58|<0.001
74037579|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.283|TWO_SIDED|95.0|-0.37|0.11|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.11|-0.37|0.283
74037580|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.003|TWO_SIDED|95.0|-0.6|-0.13|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.13|-0.60|0.003
74003040|NCT02401867|147554744|SUPERIORITY_OR_OTHER||Sensitivity|71.43|||||TWO_SIDED|95.0|47.82|88.72|||||Used exact confidence intervals.|Assessed sensitivity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||88.72|47.82|
74003041|NCT02401867|147554744|NON_INFERIORITY_OR_EQUIVALENCE|Assessed specificity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).|Specificity|98.18|||||TWO_SIDED|95.0|93.59|99.78|||||Used exact confidence intervals.|||99.78|93.59|
74003042|NCT02401867|147554744|SUPERIORITY_OR_OTHER||Positive Predictive Value|88.24|||||TWO_SIDED|95.0|63.56|98.54|||||Used exact confidence intervals.|Assessed positive predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||98.54|63.56|
74003043|NCT02401867|147554744|SUPERIORITY_OR_OTHER||Negative predictive value|94.74|||||TWO_SIDED|95.0|88.9|98.04|||||Used exact confidence intervals|Assessed negative predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||98.04|88.90|
74037581|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.027|TWO_SIDED|95.0|-0.5|-0.03|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.03|-0.50|0.027
74037582|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.054|TWO_SIDED|95.0|-0.48|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.00|-0.48|0.054
74037583|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.258|TWO_SIDED|95.0|-0.38|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.10|-0.38|0.258
74037584|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.423|TWO_SIDED|95.0|-0.14|0.34|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.34|-0.14|0.423
74037585|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.111|TWO_SIDED|95.0|-0.42|0.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.04|-0.42|0.111
74037586|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.135|TWO_SIDED|95.0|-0.36|0.05|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.05|-0.36|0.135
74037587|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.001|TWO_SIDED|95.0|-0.56|-0.14|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.14|-0.56|< 0.001
74090945|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.3|
74090946|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.54|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-3.0|
74037588|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.024|TWO_SIDED|95.0|-0.44|-0.03|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.03|-0.44|0.024
74037589|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.067|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.01|-0.40|0.067
74090947|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.12|STANDARD_ERROR_OF_MEAN|1.2419|||TWO_SIDED|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.6|
74003044|NCT03435497|147554749|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.017|TWO_SIDED||||||Regression, Linear|||||||.017
74003045|NCT03435497|147554750|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical logistic repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.5||||0.05|TWO_SIDED|95.0|0.2|1.6|||Regression, Logistic|||||1.6|0.2|.05
74037590|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.444|TWO_SIDED|95.0|-0.29|0.13|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.13|-0.29|0.444
74037591|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.285|TWO_SIDED|95.0|-0.09|0.32|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.32|-0.09|0.285
74037592|NCT03084718|147628782|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.06|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.01|-0.40|0.060
74037593|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.115|TWO_SIDED|95.0|-1.1|10.0|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.0|-1.1|0.115
74037594|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|7.6||||0.008|TWO_SIDED|95.0|2.0|13.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.1|2.0|0.008
74037595|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.099|TWO_SIDED|95.0|-0.9|10.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.2|-0.9|0.099
74037596|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.275|TWO_SIDED|95.0|-2.5|8.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.8|-2.5|0.275
74037597|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.943|TWO_SIDED|95.0|-5.4|5.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||5.8|-5.4|0.943
74037598|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.308|TWO_SIDED|95.0|-8.6|2.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||2.7|-8.6|0.308
74037599|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.024|TWO_SIDED|95.0|0.8|11.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||11.7|0.8|0.024
74037600|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.129|TWO_SIDED|95.0|-1.4|11.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.0|-1.4|0.129
74037601|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.004|TWO_SIDED|95.0|2.8|15.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||15.2|2.8|0.004
74037602|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|5.9||||0.061|TWO_SIDED|95.0|-0.3|12.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.1|-0.3|0.061
74037603|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.18|TWO_SIDED|95.0|-2.0|10.5|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||10.5|-2.0|0.180
74037604|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.721|TWO_SIDED|95.0|-5.1|7.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.4|-5.1|0.721
74037605|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.328|TWO_SIDED|95.0|-9.4|3.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||3.1|-9.4|0.328
74037606|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|7.1||||0.022|TWO_SIDED|95.0|1.0|13.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.2|1.0|0.022
74037607|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.101|TWO_SIDED|95.0|-0.9|10.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.1|-0.9|0.101
74037608|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.003|TWO_SIDED|95.0|2.8|13.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.9|2.8|0.003
73877933|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.057|||<|0.001|TWO_SIDED|95.0|0.024|0.091|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|0.024|<0.001
73877934|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.075|||<|0.001|TWO_SIDED|95.0|0.041|0.108|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.108|0.041|<0.001
74003046|NCT03435497|147554751|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.48|TWO_SIDED||||||Regression, Linear|||||||0.48
74037609|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.061|TWO_SIDED|95.0|-0.2|10.8|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.8|-0.2|0.061
74003047|NCT03435497|147554752|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED||||||Regression, Linear|||||||0.012
74003048|NCT03435497|147554753|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical logistic repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Odds Ratio (OR)|10.0||||0.022|TWO_SIDED|95.0|1.5|67.7|||Regression, Logistic|||||67.7|1.5|0.022
74003049|NCT02795429|147554759|SUPERIORITY||Odds Ratio (OR)|0.561|||||||||||Bayesian Logistic Regression Model||Posterior probability that the odds ratio (ORRspartalizumab +capmatinib to ORRspartalizumab) was ≥ 1|||||
74003050|NCT00362453|147554796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-118.8||||0.0005|TWO_SIDED|95.0|-183.66|-53.94|||Mixed Models Analysis|||||-53.94|-183.66|0.0005
74003051|NCT00362453|147554797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-324.6||||0.001|TWO_SIDED|95.0|-513.98|-135.22|||Mixed Models Analysis|||12 Week||-135.22|-513.98|0.001
74003052|NCT00362453|147554797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.2||||0.06|TWO_SIDED|95.0|-372.58|6.18|||Mixed Models Analysis|||24 Week||6.18|-372.58|0.06
74003053|NCT00362453|147554797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-105.3||||0.3|TWO_SIDED|95.0|-294.68|84.08|||Mixed Models Analysis|||48 week||84.08|-294.68|0.3
74003054|NCT00362453|147554798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.9||||0.1|TWO_SIDED|95.0|-53.04|7.24|||Mixed Models Analysis|||12 week||7.24|-53.04|0.1
74003055|NCT00362453|147554798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.8||||0.3|TWO_SIDED|95.0|-44.94|15.34|||Mixed Models Analysis|||24 week||15.34|-44.94|0.3
74003056|NCT00362453|147554798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.8|TWO_SIDED|95.0|-33.79|26.49|||Mixed Models Analysis|||48 Week||26.49|-33.79|0.8
74003057|NCT00362453|147554799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.95||||0.05|TWO_SIDED|95.0|-131.81|-2.09|||Mixed Models Analysis|||24 Week||-2.09|-131.81|0.05
74003058|NCT00362453|147554799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.15||||0.2|TWO_SIDED|95.0|-111.01|18.71|||Mixed Models Analysis|||48 Week||18.71|-111.01|0.2
74003059|NCT00362453|147554800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.01|TWO_SIDED|95.0|-3.82|-0.49|||Mixed Models Analysis|||12 Week||-0.49|-3.82|0.01
74003060|NCT00362453|147554800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.4|TWO_SIDED|95.0|-2.31|1.02|||Mixed Models Analysis|||24 Week||1.02|-2.31|0.4
74003061|NCT00362453|147554800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||1|TWO_SIDED|95.0|-1.62|1.7|||Mixed Models Analysis|||48 weeks||1.70|-1.62|1.0
74003062|NCT00362453|147554801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.002|TWO_SIDED|95.0|-2.75|-0.66|||Mixed Models Analysis|||12 Week||-0.66|-2.75|0.002
74003063|NCT00362453|147554801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.3|TWO_SIDED|95.0|-1.58|0.51|||Mixed Models Analysis|||24 Week||0.51|-1.58|0.3
74003064|NCT00362453|147554801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.06|TWO_SIDED|95.0|-2.09|0.02|||Mixed Models Analysis|||48 Week||0.02|-2.09|0.06
74003065|NCT00362453|147554802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.88||||5e-05|TWO_SIDED|95.0|-15.91|-5.84|||Mixed Models Analysis|||12 Week||-5.84|-15.91|0.00005
74003066|NCT00362453|147554802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.12||||0.05|TWO_SIDED|95.0|-10.15|-0.08|||Mixed Models Analysis|||24 Week||-0.08|-10.15|0.05
74003067|NCT00362453|147554802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98||||0.02|TWO_SIDED|95.0|-11.06|-0.91|||Mixed Models Analysis|||48 Week||-0.91|-11.06|0.02
74003068|NCT00362453|147554803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.08||||0.1|TWO_SIDED|95.0|-10.34|110.5|||Mixed Models Analysis|||12 Week||110.50|-10.34|0.1
74003069|NCT00362453|147554803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.71||||0.1|TWO_SIDED|95.0|-15.07|102.5|||Mixed Models Analysis|||24 Week||102.50|-15.07|0.1
74003070|NCT00362453|147554803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.61||||0.7|TWO_SIDED|95.0|-49.36|78.59|||Mixed Models Analysis|||48 Weeks||78.59|-49.36|0.7
74003071|NCT00362453|147554804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.54|0.34|||Mixed Models Analysis|||12 Weeks||0.34|-0.54|0.7
74003072|NCT00362453|147554804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.7|TWO_SIDED|95.0|-0.37|0.52|||Mixed Models Analysis|||24 Weeks||0.52|-0.37|0.7
74003073|NCT00362453|147554804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.6|TWO_SIDED|95.0|-0.55|0.34|||Mixed Models Analysis|||48 weeks||0.34|-0.55|0.6
74003074|NCT00362453|147554805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.009|TWO_SIDED|95.0|-11.63|-1.77|||Mixed Models Analysis|||12 Week||-1.77|-11.63|0.009
74003075|NCT00362453|147554805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.04|TWO_SIDED|95.0|-10.23|-0.37|||Mixed Models Analysis|||24 Weeks||-0.37|-10.23|0.04
74003076|NCT00362453|147554805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9||||0.0006|TWO_SIDED|95.0|-13.83|-3.97|||Mixed Models Analysis|||48 Week||-3.97|-13.83|0.0006
74003077|NCT00362453|147554806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.04|TWO_SIDED|95.0|0.03|1.39|||Mixed Models Analysis|||12 Weeks||1.39|0.03|0.04
74003078|NCT00362453|147554806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.02|TWO_SIDED|95.0|0.17|1.53|||Mixed Models Analysis|||24 Weeks||1.53|0.17|0.02
74003079|NCT00362453|147554806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.007|TWO_SIDED|95.0|0.28|1.64|||Mixed Models Analysis|||48 Weeks||1.64|0.28|0.007
74003080|NCT00362453|147554807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.43||||0.004|TWO_SIDED|95.0|2.5|12.36|||Mixed Models Analysis|||12 Weeks||12.36|2.50|0.004
74003081|NCT00362453|147554807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.51||||0.08|TWO_SIDED|95.0|-0.42|9.45|||Mixed Models Analysis|||24 Weeks||9.45|-0.42|0.08
74003082|NCT00362453|147554807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.32||||0.01|TWO_SIDED|95.0|1.38|11.25|||Mixed Models Analysis|||48 Weeks||11.25|1.38|0.01
74003083|NCT00362453|147554808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.9|TWO_SIDED|95.0|-6.15|6.57|||Mixed Models Analysis|||12 Weeks||6.57|-6.15|0.9
74003084|NCT00362453|147554808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||1|TWO_SIDED|95.0|-6.47|6.25|||Mixed Models Analysis|||24 Weeks||6.25|-6.47|1.0
74003085|NCT00362453|147554808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.77||||0.1|TWO_SIDED|95.0|-1.59|11.13|||Mixed Models Analysis|||48 Weeks||11.13|-1.59|0.10
74003086|NCT03645057|147554832|SUPERIORITY|||||||0.433|||||||Wilcoxon rank sum test|||||||0.433
74003087|NCT03645057|147554833|SUPERIORITY|||||||0.836|||||||Wilcoxon rank sum test|||||||0.836
74003088|NCT03645057|147554834|SUPERIORITY|||||||0.073|||||||Wilcoxon rank sum test|||||||0.073
74003089|NCT03645057|147554835|SUPERIORITY|||||||0.989|||||||Wilcoxon rank sum test|||||||0.989
74003090|NCT03645057|147554836|SUPERIORITY|||||||0.565|||||||Wilcoxon rank sum test|||||||0.565
74003091|NCT03645057|147554837|SUPERIORITY|||||||0.479|||||||Wilcoxon rank sum test|||||||0.479
74003092|NCT03645057|147554838|SUPERIORITY|||||||0.577|||||||Wilcoxon rank sum test|||||||0.577
74003093|NCT03645057|147554839|SUPERIORITY|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||||||0.439
74003094|NCT03645057|147554840|SUPERIORITY|||||||0.242|||||||Wilcoxon rank sum test|||||||0.242
74003095|NCT02047643|147554851|OTHER|||||||0.45|||||||Fisher Exact|Two-sided Fisher Exact test||||||.45
74003096|NCT02047643|147554852|OTHER|||||||0.66|||||||Fisher Exact|Two-sided Fisher Exact test||||||.66
74003097|NCT01708213|147554933|SUPERIORITY_OR_OTHER||Parametric Testing|0.05|||<|0.05|TWO_SIDED||||||Parametric testing|||||||<0.05
74003098|NCT04964414|147554939|SUPERIORITY|||||||0.6|||||||Paired t-test|||||||0.6
74003099|NCT04964414|147554940|SUPERIORITY|||||||0.6|||||||Wilcoxon signed-rank|||||||0.6
74003100|NCT04964414|147554941|SUPERIORITY|||||||0.09|||||||Paired t-test|||||||0.09
74003101|NCT04964414|147554946|SUPERIORITY|||||||0.2|||||||Paired t-test|||||||0.2
74003102|NCT04964414|147554947|SUPERIORITY|||||||0.2|||||||Paired t-test|||||||0.2
74003103|NCT01718353|147554949|OTHER|||||||0.02|||||||ANOVA|||%ARNL change from baseline at Cycle 1 Day 8 in participants with ≥50% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥50% decrease in PSA at Cycle 4||||0.02
74003104|NCT01718353|147554957|OTHER|||||||0.0927|||||||ANOVA|||MTB change from baseline at Cycle 1 Day 8 in participants with ≥30% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥30% decrease in PSA at Cycle 4||||0.0927
74003105|NCT01691768|147554996|NON_INFERIORITY|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control).|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-1.16|0.21||||Univariate Linear Mixed Models were used to analyze primary outcome.|The least square mean from the intervention arm was the minuend and the least square mean from the control arm was the subtrahend.|Intent to treat population (all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data) was used for this analyses.|The primary endpoint was compared using univariate linear mixed model with compound symmetry structure.|0.21|-1.16|
74008853|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.6|||<|0.0001|TWO_SIDED|95.0|-11.7|-9.6|||t-test, 1 sided|||Mean daytime diastolic blood pressure||-9.6|-11.7|<0.0001
74008854|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.6|||<|0.0001|TWO_SIDED|95.0|-8.8|-6.4|||t-test, 1 sided|||Mean nighttime diastolic blood pressure||-6.4|-8.8|<0.0001
74008855|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6|||<|0.0001||95.0|-10.0|-7.2|||t-test, 1 sided|||diastolic blood pressure during last 2 hours of dose||-7.2|-10.0|<0.0001
74008856|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0|||<|0.0001|TWO_SIDED|95.0|-9.2|-6.8|||t-test, 1 sided|||diastolic blood pressure during last 4 hours of dose||-6.8|-9.2|<0.0001
74008857|NCT00791258|147568103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.7|||<|0.0001||95.0|-8.8|-6.6|||t-test, 1 sided|||diastolic blood pressure during last 6 hours of dose||-6.6|-8.8|<0.0001
74008858|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.0|||<|0.0001|TWO_SIDED|95.0|-22.6|-19.3|||t-test, 1 sided|||24-hour mean systolic blood pressure||-19.3|-22.6|<0.0001
74003106|NCT01691768|147554996|NON_INFERIORITY|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control)|Median Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.98|0.48||||Univariable Linear Mixed Models was used for the analyses|We calculated the difference in means between the two arms. The mean from the intervention arm was the minuend and the mean from the control arm was the subtrahend.|This is the analyses from the per protocol population (excluding all subsequent data collected from participants who were not dispensed product for more than 120 days).||0.48|-0.98|
74003107|NCT01691768|147554997|SUPERIORITY||Incidence rate ratio|0.96||||0.928|TWO_SIDED|95.0|0.4|2.35|||z-test|We used z-test to compare incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the HIV incidence rate for the intervention arm represents the numerator and the HIV incidence rate for the control arm represents the denominator.|The power was not calculated for all the secondary outcomes.||2.35|0.40|0.928
74003108|NCT01691768|147554998|SUPERIORITY||incidence rate ratio|0.96||||0.895|TWO_SIDED|95.0|0.45|2.04|||z-test|We used z-test to compare pregnancy incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the pregnancy incidence rate for the intervention arm represents the numerator and the pregnancy incidence rate for the control arm represents the denominator.|Power was not calculated for all the secondary outcomes.||2.04|0.45|0.895
74003109|NCT01691768|147554999|SUPERIORITY||Risk Ratio (RR)|1.08||||0.304|TWO_SIDED|95.0|0.94|1.24|||Regression, Log-binomial|||Power was not calculated for all secondary outcomes.||1.24|0.94|0.304
74003110|NCT01691768|147555000|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||||||0.455
74003111|NCT01691768|147555002|SUPERIORITY||incidence rate ratio|0.33||||0.097|TWO_SIDED|95.0|0.06|1.32|||z-test||We calculated incidence rate ratio, where the HPV incidence rate for the intervention arm represents the numerator and the HPV incidence rate for the control arm represents the denominator.|||1.32|0.06|0.097
74003112|NCT01691768|147555003|SUPERIORITY||Risk Ratio (RR)|0.91||||0.462|TWO_SIDED|95.0|0.7|1.18|||Regression, Log-binomial|||||1.18|0.70|0.462
74003113|NCT00887432|147555008|SUPERIORITY||Mean Difference (Net)|0.24||||0.431|TWO_SIDED|95.0|-0.36|0.84||Significance level of 0.05.|t-test, 2 sided|Paired t-test, df=86||Evaluated the change in PSA under the vitamin D and placebo conditions using the combined data (n=87).||0.84|-0.36|0.431
74003114|NCT00887432|147555009|SUPERIORITY|Comparing the mean PSA slopes between conditions (on vitamin D versus on placebo).|Mean Difference (Net)|-0.00019||||0.112|TWO_SIDED|95.0|-0.00042|0.000045||Significance level of 0.05.|Mixed Models Analysis|||||0.000045|-0.00042|0.112
74003115|NCT01209780|147555033|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if for all three strains the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational) at 21 days after last vaccination does not exceed 10 percentage points.|Vaccine group difference (%)|-1.0|||||TWO_SIDED|95.0|-4.0|2.0||||||Non-inferiority of investigational TIV to control TIV against A/H1N1 influenza strain||2|-4|
74003116|NCT01209780|147555033|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|10.0|||||TWO_SIDED|95.0|6.0|14.0||||||Non-inferiority of investigational TIV to control TIV against A/H3N2 influenza strain||14|6|
74003117|NCT01209780|147555033|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|-1.0|||||TWO_SIDED|95.0|-5.0|3.0||||||Non-inferiority of investigational TIV to the control TIV against B influenza strain||3|-5|
74003118|NCT01209780|147555035|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.11|1.56||||||Non-inferiority of investigational TIV to licensed control TIV against A/H1N1 influenza strain||1.56|1.11|
74003119|NCT01209780|147555035|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.34|1.64||||||Non-inferiority of investigational TIV to licensed control TIV against A/H3N2 influenza strain||1.64|1.34|
74003120|NCT01209780|147555035|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.85|1.07||||||Non-inferiority of investigational TIV to licensed control TIV against B influenza strain||1.07|0.85|
74090948|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.2344|||TWO_SIDED|95.0|-3.7|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-3.7|
74003121|NCT05007808|147555045|SUPERIORITY|ANCOVA model with Change from Baseline to Week 4/EOT as the outcome (dependent) variable, treatment as the independent variable, and baseline score as covariate. The p-value was derived from the t-test for the comparison of adjusted LS means between the treatment groups.|LS Mean Difference|-0.19||||0.6742|TWO_SIDED|95.0|-1.081|0.701|||t-test, 2 sided|||||0.701|-1.081|0.6742
74090949|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.89|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-4.3|0.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.5|-4.3|
74003122|NCT01275131|147555089|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.95||||0.0009|TWO_SIDED|90.0|7.37|20.54|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 2/6||20.54|7.37|0.0009
74003123|NCT01275131|147555089|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|18.14|||<|0.0001|TWO_SIDED|90.0|11.55|24.72|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 4/8||24.72|11.55|<0.0001
74003124|NCT01275131|147555091|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.41|||<|0.0001|TWO_SIDED|90.0|11.86|20.97|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 2/7||20.97|11.86|<0.0001
74037610|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|3.7||||0.196|TWO_SIDED|95.0|-1.9|9.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.3|-1.9|0.196
74037611|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.814|TWO_SIDED|95.0|-4.9|6.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.3|-4.9|0.814
74037612|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.291|TWO_SIDED|95.0|-8.6|2.6|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||2.6|-8.6|0.291
74090950|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.16|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.6|
74090951|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.3|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.3|
73877935|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.308|TWO_SIDED|95.0|-0.016|0.051|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.051|-0.016|0.308
74003125|NCT01275131|147555091|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|14.1|||<|0.0001|TWO_SIDED|90.0|9.55|18.65|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 3/8||18.65|9.55|<0.0001
74003126|NCT01275131|147555091|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.32||||0.0552|TWO_SIDED|90.0|0.77|9.88|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 5/10||9.88|0.77|0.0552
74037613|NCT03084718|147628783|SUPERIORITY||Mean Difference (Final Values)|6.7||||0.016|TWO_SIDED|95.0|1.3|12.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||12.1|1.3|0.016
74037614|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
74037615|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
74037616|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
74037617|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.913|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.913
74090952|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-3.1|1.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-3.1|
74090953|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.0|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-2.0|
74090954|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.3|
74090955|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.71|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-4.1|0.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.7|-4.1|
74008859|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.2|||<|0.0001|TWO_SIDED|95.0|-25.1|-21.4|||t-test, 1 sided|||Mean daytime systolic blood pressure||-21.4|-25.1|<0.0001
74008860|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.5|||<|0.0001|TWO_SIDED|95.0|-19.4|-15.6|||t-test, 1 sided|||Mean nighttime systolic blood pressure||-15.6|-19.4|<0.0001
74008861|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.6|||<|0.0001|TWO_SIDED|95.0|-21.7|-17.4|||t-test, 1 sided|||Systolic blood pressure - last 2 hours of dose||-17.4|-21.7|<0.0001
74008862|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.2|||<|0.0001|TWO_SIDED|95.0|-20.2|-16.3|||t-test, 1 sided|||Systolic blood pressure - last 4 hours of dose||-16.3|-20.2|<0.0001
74008863|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.9|||<|0.0001|TWO_SIDED|95.0|-19.7|-16.0|||t-test, 1 sided|||Systolic blood pressure - last 6 hours of dose||-16.0|-19.7|<0.0001
74008864|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.3|||<|0.0001|TWO_SIDED|95.0|-14.4|-12.2|||t-test, 1 sided|||24-hour mean diastolic blood pressure||-12.2|-14.4|<0.0001
74008865|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|||<|0.0001|TWO_SIDED|95.0|-16.2|-13.8|||t-test, 1 sided|||Mean daytime diastolic blood pressure||-13.8|-16.2|<0.0001
74008866|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.1|||<|0.0001|TWO_SIDED|95.0|-12.4|-9.8|||t-test, 1 sided|||Mean nighttime diastolic blood pressure||-9.8|-12.4|<0.0001
74008867|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.3|||<|0.0001|TWO_SIDED|95.0|-13.8|-10.8|||t-test, 1 sided|||Diastolic blood pressure - last 2 hours of dose||-10.8|-13.8|<0.0001
74008868|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.6|||<|0.0001|TWO_SIDED|95.0|-12.9|-10.2|||t-test, 1 sided|||Diastolic blood pressure - last 4 hours of dose||-10.2|-12.9|<0.0001
74008869|NCT00791258|147568104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.3|||<|0.0001|TWO_SIDED|95.0|-12.6|-10.0|||t-test, 1 sided|||Diastolic blood pressure - last 6 hours of dose||-10.0|-12.6|<0.0001
74008870|NCT02319668|147568153|SUPERIORITY_OR_OTHER||Least square (LS) Mean difference|0.2||||0.2965|TWO_SIDED|95.0|-0.18|0.58|||ANCOVA|ANCOVA with treatment as factor and baseline as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.58|-0.18|0.2965
74008871|NCT01372150|147568157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.226|TWO_SIDED|95.0|-1.06|4.48|||Mixed-effects model for repeated measure|Mixed-effects model for repeated measures (MMRM)|Adjusted mean difference = placebo - fluoxetine|Fluoxetine versus Placebo||4.48|-1.06|0.226
74008872|NCT01372150|147568157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.739|TWO_SIDED|95.0|-3.23|2.3|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo||2.30|-3.23|0.739
74008873|NCT01372150|147568158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.224|TWO_SIDED|95.0|-0.11|0.46|||MMRM||Adjusted mean difference = Placebo - Fluoxetine|Fluoxetine versus Placebo||0.46|-0.11|0.224
74008874|NCT01372150|147568158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.944|TWO_SIDED|95.0|-0.29|0.27|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo||0.27|-0.29|0.944
73877936|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.092|||<|0.001|TWO_SIDED|95.0|0.038|0.147|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.147|0.038|<0.001
73877937|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.079|0.188|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.188|0.079|<0.001
73877938|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.174|||<|0.001|TWO_SIDED|95.0|0.12|0.229|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.229|0.120|<0.001
74003127|NCT00731120|147555103|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.803||0.279|TWO_SIDED|95.0|-2.45|0.71||Hierarchical testing stopped at 10 mg versus placebo for HAM-A total score at Week 8 in the testing sequence, a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.||P-values were tested at the 5% significance level (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||0.71|-2.45|0.279
74003128|NCT00731120|147555103|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.791||0.306|TWO_SIDED|95.0|-2.36|0.74||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.||||0.74|-2.36|0.306
74003129|NCT02434939|147555148|NON_INFERIORITY_OR_EQUIVALENCE|a clinically significant difference in validated pain scores was defined as 1.3. assuming both treatments are on average equal, 240 patients provided 95% power to demonstrate that IV low dose ketamine is non inferior to IV morphine with a 0.05 level of significance.|Mean Difference (Final Values)|5.5||||0.18|TWO_SIDED|95.0|-2.2|13.2|||t-test, 2 sided|||||13.2|-2.2|0.18
74003130|NCT02434939|147555151|NON_INFERIORITY_OR_EQUIVALENCE|A clinically meaningful difference in validated pain scores was defined as 1.3.Assuming both treatments are on average equal, a sample size of 240 patients (120 per group) provided 95% power to demonstrate that IV LDK is non-inferior to IV morphine with a 0.05 level of significance.||||||0.07|||||||t-test, 2 sided|||||||0.07
74003131|NCT02594826|147555184|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|35.8|||<|0.001|TWO_SIDED|95.0|11.1|114.9|||Mixed Models Analysis|This is the calculated p-value, which is adjusted for age, marital status, prior screening, health insurance, and having a healthcare provider.||||114.9|11.1|<0.001
74003132|NCT02594826|147555185|SUPERIORITY|||||||0.005|||||||Regression, Linear|Controlling for: marital status, education, language spoken at home, health insurance, regular physician, language of physician, ever had Pap test.||The null hypothesis is that the two conditions would not differ in their knowledge following program participation. The study biostatistician conducted full regression models to examine change in knowledge (from pre- to post-program) within each group and across groups over time. The models controlled for relevant covariates.||||0.005
73877939|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.181|||<|0.001|TWO_SIDED|95.0|0.127|0.235|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.235|0.127|<0.001
73877940|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.229|||<|0.001|TWO_SIDED|95.0|0.175|0.284|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.284|0.175|<0.001
74003133|NCT00557947|147555187|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|difference proportions of successes (%)|4.8||||0.2188|TWO_SIDED|95.0|0.0|10.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.|||10.9|-0.0|0.2188
74003134|NCT00557947|147555188|SUPERIORITY_OR_OTHER||||||<|0.0001||0.0|||||t-test, 2 sided|||||||<0.0001
74003135|NCT00557947|147555189|SUPERIORITY_OR_OTHER|||||||0.3877||0.0|||||McNemar|||||||0.3877
74003136|NCT00557947|147555190|SUPERIORITY_OR_OTHER|||||||0.7539||0.0|||||McNemar|||||||0.7539
74003137|NCT00557947|147555191|SUPERIORITY_OR_OTHER|||||||1||0.0|||||McNemar|||||||1.0000
74003138|NCT01912456|147555201|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
74003139|NCT01912456|147555201|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
74003140|NCT01912456|147555201|OTHER||||||=|0.114|||||||Mixed Models Analysis|||||||= 0.114
74003141|NCT01912456|147555202|OTHER||difference in percentages of responder|13.8|||||TWO_SIDED|95.0|-2.8|29.7||||||||29.7|-2.8|
74003142|NCT01912456|147555203|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
74003143|NCT01912456|147555203|OTHER||||||=|0.018|||||||Mixed Models Analysis|||||||= 0.018
74003144|NCT01912456|147555203|OTHER||||||=|0.31|||||||Mixed Models Analysis|||||||= 0.31
74003145|NCT01440374|147555221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.202||||0.0315|TWO_SIDED|95.0|0.047|0.868|||Generalized Linear Mixed Models|||||0.868|0.047|0.0315
74008875|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.924||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 1||||0.924
73877941|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.141|TWO_SIDED|95.0|-0.013|0.095|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.095|-0.013|0.141
73877942|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.003|TWO_SIDED|95.0|0.028|0.137|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.137|0.028|0.003
74003146|NCT00231153|147555248|SUPERIORITY_OR_OTHER||Net percentage difference|2.25||||0.082||95.0|-0.3|4.81||The primary null hypothesis was tested using the CMH chi-square test stratified region: North America or Europe. Alpha for this test will be 0.05, tow-tailed. No adjustment for multiplicity was performed.|Cochran-Mantel-Haenszel|||Adequate power was provided to test the null hypothesis that there would be no difference between treatment groups for LCSI. Overall LCSI rate was assumed to be approx. 7.5%, with reduction of LCSI by 40% with omiganan. LCSI rates in placebo and omiganan groups would be 9.375% and 5.625%. Sample size of 1548 in MITT set would provide 80% power to detect this difference between treatments. Sample size was also increased by 19% to account for deaths, for total of 1850 planned patients.||4.81|-0.30|0.082
74003147|NCT00231153|147555249|SUPERIORITY_OR_OTHER||Net percentage difference|3.67||||0.002||95.0|1.4|5.93|||Cochran-Mantel-Haenszel|||||5.93|1.40|0.002
74003148|NCT00231153|147555250|SUPERIORITY_OR_OTHER||Net percentage difference|11.4|||<|0.001||95.0|6.7|16.11|||Cochran-Mantel-Haenszel|||||16.11|6.70|<0.001
74003149|NCT04487834|147555251|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74003150|NCT04487834|147555252|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
74003151|NCT04487834|147555253|SUPERIORITY|||||||0.4852|||||||Fisher Exact|||||||0.4852
74003152|NCT04234425|147555271|OTHER|paired t test|Mean Difference (Final Values)|2.702|STANDARD_DEVIATION|5.36||0.017|TWO_SIDED||||||t-test, 2 sided|||||||.017
73877943|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.088||||0.001|TWO_SIDED|95.0|0.035|0.142|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.142|0.035|0.001
73877944|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.137|TWO_SIDED|95.0|-0.013|0.096|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.096|-0.013|0.137
74003153|NCT04234425|147555272|OTHER|paired t test|Mean Difference (Final Values)|4.2|STANDARD_DEVIATION|7.06||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.08
74003154|NCT04234425|147555273|OTHER|paired t test|Mean Difference (Final Values)|20.47|STANDARD_DEVIATION|7.33||0.026|TWO_SIDED||||||t-test, 2 sided|||||||.026
74003155|NCT03442985|147555275|OTHER||Risk Ratio (RR)|2.109||||0.2556|TWO_SIDED|95.0|0.583|7.638||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 2.5 mg versus (vs) Palovarotene 5.0 mg: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||7.638|0.583|0.2556
74037618|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.871|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.871
74037619|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.958
74003156|NCT03442985|147555275|OTHER||Risk Ratio (RR)|3.04||||0.1788|TWO_SIDED|95.0|0.601|15.373||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||15.373|0.601|0.1788
74003157|NCT03442985|147555275|OTHER||Risk Ratio (RR)|1.441||||0.657|TWO_SIDED|95.0|0.287|7.234||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||7.234|0.287|0.6570
74003158|NCT03442985|147555276|OTHER||Risk Ratio (RR)|-4412.6||||0.4252|TWO_SIDED|95.0|-15257.3|6432.1||The p-values were not adjusted for multiple testing due to small sample size.|Unadjusted estimation equation model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||6432.1|-15257.3|0.4252
74003159|NCT03442985|147555276|OTHER||Risk Ratio (RR)|-4640.9||||0.4053|TWO_SIDED|95.0|-15570.8|6289.0||The p-values were not adjusted for multiple testing due to small sample size.|Unadjusted estimation equation model|||Palovarotene 2.5 mg vs Placebo: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||6289.0|-15570.8|0.4053
74003160|NCT03442985|147555276|OTHER||Risk Ratio (RR)|-228.3||||0.9677|TWO_SIDED|95.0|-11265.0|10808.4||The p-values were not adjusted for multiple testings due to small sample size.|Unadjusted estimation equation model|||Palovarotene 5.0 mg vs Placebo: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||10808.4|-11265.0|0.9677
74037620|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
73877945|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.082|TWO_SIDED|95.0|-0.006|0.101|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.101|-0.006|0.082
74003161|NCT03442985|147555277|OTHER||Odds Ratio (OR)|0.643||||0.5025|TWO_SIDED|95.0|0.177|2.335|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||2.335|0.177|0.5025
74003162|NCT03442985|147555277|OTHER||Odds Ratio (OR)|0.528||||0.3763|TWO_SIDED|95.0|0.128|2.175|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||2.175|0.128|0.3763
74003163|NCT03442985|147555277|OTHER||Odds Ratio (OR)|0.82||||0.7714|TWO_SIDED|95.0|0.215|3.123|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||3.123|0.215|0.7714
74003164|NCT03442985|147555278|OTHER||Risk Ratio (RR)|0.951||||0.8155|TWO_SIDED|95.0|0.623|1.451||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.451|0.623|0.8155
74003165|NCT03442985|147555278|OTHER||Risk Ratio (RR)|1.003||||0.9918|TWO_SIDED|95.0|0.592|1.699||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.699|0.592|0.9918
74003166|NCT03442985|147555278|OTHER||Risk Ratio (RR)|1.055||||0.7997|TWO_SIDED|95.0|0.7|1.589||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.589|0.700|0.7997
74003167|NCT03442985|147555279|OTHER||Risk Ratio (RR)|1.548||||0.2186|TWO_SIDED|95.0|0.772|3.108||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||3.108|0.772|0.2186
74003168|NCT03442985|147555279|OTHER||Risk Ratio (RR)|1.655||||0.27|TWO_SIDED|95.0|0.676|4.052||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||4.052|0.676|0.2700
74008876|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.698||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 1||||0.698
74008877|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.214||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 2||||0.214
74008878|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.113||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 2||||0.113
74008879|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.314||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 3||||0.314
74008880|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.659||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 3||||0.659
74008881|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.577||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 4||||0.577
74008882|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.187||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 4||||0.187
74008883|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.051||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 6||||0.051
74008884|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.266||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 6||||0.266
74008885|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.095||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 8||||0.095
74008886|NCT01372150|147568159|SUPERIORITY_OR_OTHER|||||||0.852||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 8||||0.852
74008887|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.186|TWO_SIDED|95.0|0.226|1.335|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 1||1.335|0.226|0.186
74008888|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.984|TWO_SIDED|95.0|0.382|2.567|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 1||2.567|0.382|0.984
74003169|NCT03442985|147555279|OTHER||Risk Ratio (RR)|1.069||||0.8546|TWO_SIDED|95.0|0.524|2.178||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||2.178|0.524|0.8546
74003170|NCT03794908|147555294|SUPERIORITY||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|3.49||0.28|TWO_SIDED|95.0|-3.03|10.64|||Mixed Models Analysis|The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).||Test of between-arm difference at mid-treatment.||10.64|-3.03|0.28
74003171|NCT03794908|147555294|SUPERIORITY||Mean Difference (Net)|4.48|STANDARD_ERROR_OF_MEAN|3.53||0.21|TWO_SIDED|95.0|-2.44|11.4|||Mixed Models Analysis|The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).||Test of between-arm difference at end of treatment.||11.40|-2.44|0.21
74003172|NCT00120406|147555301|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 10%.|||||<|0.01||95.0||||P-value has been adjusted for multiplicity.|z-test, one-sided|||||||<0.01
74003173|NCT00120406|147555302|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||P-value has been adjusted for multiplicity.|Generalized estimating equation (GEE)|||||||<0.01
74003174|NCT01313637|147555315|SUPERIORITY_OR_OTHER||Least squares mean difference|0.16|||<|0.001|TWO_SIDED|95.0|0.122|0.198|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 125 µg minus Placebo.|||0.198|0.122|<0.001
74003175|NCT01313637|147555315|SUPERIORITY_OR_OTHER||Least squares mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.086|0.162|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.|||0.162|0.086|<0.001
74003176|NCT01313637|147555315|SUPERIORITY_OR_OTHER||Least squares mean difference|0.238|||<|0.001|TWO_SIDED|95.0|0.2|0.276|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus Placebo.|||0.276|0.200|<0.001
74037621|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.01|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.010
74037622|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.011|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.011
74037623|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.002|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.002
74037624|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.996
74037625|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.632|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.632
74037626|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.63|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.630
74037627|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
74037628|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.002|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.002
74090956|NCT02037165|147735939|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.18|STANDARD_ERROR_OF_MEAN|1.2344|||TWO_SIDED|95.0|-3.6|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.6|
74090957|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|0.79|STANDARD_ERROR_OF_MEAN|1.1758|||TWO_SIDED|95.0|-1.5|3.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.1|-1.5|
74003177|NCT01313637|147555315|SUPERIORITY_OR_OTHER||Least squares mean difference|0.079|||<|0.001|TWO_SIDED|95.0|0.046|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus UMEC 125 µg.|||0.112|0.046|<0.001
74037629|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.001|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.001
74037630|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
74037631|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.96|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.960
74003178|NCT01313637|147555315|SUPERIORITY_OR_OTHER||Least squares mean difference|0.114|||<|0.001|TWO_SIDED|95.0|0.081|0.148|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus VI 25 µg.|||0.148|0.081|<0.001
74003179|NCT04218084|147555320|OTHER|Mixed Model Repeated Measures analysis|Difference in LS mean|-7.73||||0.0043|TWO_SIDED|95.0|-13.03|-2.42|||Mixed Models for Repeated Measures|||Week 24||-2.42|-13.03|0.0043
74003180|NCT00712673|147555345|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.657|-0.312||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(\<8.0,\>=8.0%),BMI(\<30,\>=30 kg/m\^2),country as fixed effects, baseline HbA1c as covariate.||-0.312|-0.657|<0.0001
74003181|NCT00712673|147555345|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.54|-0.193||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(\<8.0,\>=8.0%),BMI(\<30,\>=30 kg/m\^2),country as fixed effects, baseline HbA1c as covariate.||-0.193|-0.540|<0.0001
74003182|NCT01468831|147555381|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|7.8|STANDARD_DEVIATION|7.4|||TWO_SIDED|95.0|-10.6|26.1|||||Difference = Minocycline - Placebo|||26.1|-10.6|
74003183|NCT01468831|147555382|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 12 is reported.|Mean Difference (Net)|1.1|STANDARD_DEVIATION|1.4|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74003184|NCT01468831|147555383|OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|3.5|||TWO_SIDED||||||||Difference = Minocycline - Placebo|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 24 is reported.||||
74003185|NCT01468831|147555384|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 3 compared to baseline is reported.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.3|||TWO_SIDED|95.0|-3.9|2.3|||||Difference = Minocycline - Placebo|||2.3|-3.9|
73877946|NCT03084796|147295443|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.823|TWO_SIDED|95.0|-0.048|0.06|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.060|-0.048|0.823
74037632|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.725|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.725
74003186|NCT01468831|147555385|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-2.1|STANDARD_DEVIATION|1.0|||TWO_SIDED|95.0|-4.5|0.3|||||Difference = Minocycline - Placebo|||0.3|-4.5|
74003187|NCT01468831|147555386|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-2.5|STANDARD_DEVIATION|1.8|||TWO_SIDED|95.0|-7.5|2.5|||||Difference = Minocycline - Placebo|||2.5|-7.5|
74003188|NCT01468831|147555387|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-3.5|STANDARD_DEVIATION|2.2|||TWO_SIDED|95.0|-9.4|2.4|||||Difference = Minocycline - Placebo|||2.4|-9.4|
74003189|NCT01468831|147555388|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-3.7|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-9.5|2.0|||||Difference = Minocycline - Placebo|||2|-9.5|
74003190|NCT01468831|147555389|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|5.8|STANDARD_DEVIATION|9.1|||TWO_SIDED|95.0|-17.1|28.6|||||Difference = Minocycline - Placebo|||28.6|-17.1|
74003191|NCT01468831|147555390|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-51.8|STANDARD_DEVIATION|70.8|||TWO_SIDED|95.0|-231.2|127.6|||||Difference = Minocycline - Placebo|||127.6|-231.2|
74003192|NCT01468831|147555391|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-45.5|STANDARD_DEVIATION|153.5|||TWO_SIDED|95.0|-522.6|431.6|||||Difference = Minocycline - Placebo|||431.6|-522.6|
74003193|NCT01468831|147555392|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-12.8|STANDARD_DEVIATION|163.8|||TWO_SIDED|95.0|-513.1|487.6|||||Difference = Minocycline - Placebo|||487.6|-513.1|
74003194|NCT01468831|147555393|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-9.5|STANDARD_DEVIATION|156.8|||TWO_SIDED|95.0|-487.0|468.0|||||Difference = Minocycline - Placebo|||468|-487|
74037633|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.764|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.764
74090958|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|0.51|STANDARD_ERROR_OF_MEAN|1.1755|||TWO_SIDED|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-1.8|
74090959|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|2.06|STANDARD_ERROR_OF_MEAN|0.1752|||TWO_SIDED|95.0|-0.2|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-0.2|
74090960|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|1.33|STANDARD_ERROR_OF_MEAN|1.1751|||TWO_SIDED|95.0|-1.0|3.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.6|-1.0|
74090961|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|1.12|STANDARD_ERROR_OF_MEAN|1.175|||TWO_SIDED|95.0|-1.2|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-1.2|
74090962|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.57|STANDARD_ERROR_OF_MEAN|1.1751|||TWO_SIDED|95.0|-2.9|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-2.9|
74090963|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.43|STANDARD_ERROR_OF_MEAN|1.1752|||TWO_SIDED|95.0|-3.7|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-3.7|
74003195|NCT01468831|147555394|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 12 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74003196|NCT01468831|147555395|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 24 compared to baseline is reported|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74003197|NCT01468831|147555396|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|-2.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74037634|NCT03084718|147628784|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
74003198|NCT01468831|147555396|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74003199|NCT01468831|147555396|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|2.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74037635|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|2.9||||0.316|TWO_SIDED|95.0|-2.8|8.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||8.7|-2.8|0.316
74037636|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|4.9||||0.097|TWO_SIDED|95.0|-0.9|10.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||10.7|-0.9|0.097
74037637|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.128|TWO_SIDED|95.0|-1.3|10.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.2|-1.3|0.128
74037638|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.511|TWO_SIDED|95.0|-3.9|7.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.8|-3.9|0.511
74037639|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.61|TWO_SIDED|95.0|-4.3|7.3|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.3|-4.3|0.610
74037640|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.882|TWO_SIDED|95.0|-6.3|5.4|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||5.4|-6.3|0.882
74090964|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|0.24|STANDARD_ERROR_OF_MEAN|1.1755|||TWO_SIDED|95.0|-2.1|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.1|
74090965|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|0.43|STANDARD_ERROR_OF_MEAN|1.1758|||TWO_SIDED|95.0|-1.9|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-1.9|
74090966|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.68|STANDARD_ERROR_OF_MEAN|1.1567|||TWO_SIDED|95.0|-4.0|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-4.0|
74090967|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|0.52|STANDARD_ERROR_OF_MEAN|1.1566|||TWO_SIDED|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-1.8|
74090968|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|1.89|STANDARD_ERROR_OF_MEAN|1.1565|||TWO_SIDED|95.0|-0.4|4.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.2|-0.4|
74090969|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|1.25|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-1.0|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.5|-1.0|
73877947|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.002|TWO_SIDED|95.0|0.022|0.1|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.100|0.022|0.002
74037641|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|7.2||||0.013|TWO_SIDED|95.0|1.5|12.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||12.9|1.5|0.013
74037642|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.219|TWO_SIDED|95.0|-2.8|12.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||12.2|-2.8|0.219
74037643|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.166|TWO_SIDED|95.0|-2.2|12.8|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||12.8|-2.2|0.166
74037644|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.151|TWO_SIDED|95.0|-2.0|12.9|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.9|-2.0|0.151
74037645|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.871|TWO_SIDED|95.0|-6.9|8.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.2|-6.9|0.871
74090970|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|0.67|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-1.6|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-1.6|
74090971|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference of 200 mg BI mi|-0.43|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-2.7|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-2.7|
74090972|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.76|STANDARD_ERROR_OF_MEAN|1.1565|||TWO_SIDED|95.0|-3.0|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-3.0|
74090973|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|1.1566|||TWO_SIDED|95.0|-2.2|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.4|-2.2|
74090974|NCT02037165|147735940|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.71|STANDARD_ERROR_OF_MEAN|1.1567|||TWO_SIDED|95.0|-3.0|1.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.6|-3.0|
74003200|NCT01468831|147555397|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|-1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74003201|NCT01468831|147555397|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74003202|NCT01468831|147555397|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74003203|NCT02656160|147555424|OTHER|||||||0.85||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||tonic||||0.85
74037646|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.837|TWO_SIDED|95.0|-6.8|8.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.3|-6.8|0.837
74003204|NCT02656160|147555424|OTHER|||||||0.322||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||Phasic activity||||0.322
74003205|NCT02656160|147555425|OTHER|||||||0.42||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.42
74003206|NCT02076178|147555426|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||Any Grade 2 or higher event, any Grade 2 or higher event Vs Cabotegravir||||<0.01
74003207|NCT00710021|147555443|SUPERIORITY_OR_OTHER|||||||0.53||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.53
74003208|NCT00710021|147555444|SUPERIORITY_OR_OTHER|||||||0.038||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.038
74003209|NCT00710021|147555445|SUPERIORITY_OR_OTHER|||||||0.047||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.047
74003210|NCT00710021|147555446|SUPERIORITY_OR_OTHER|||||||0.12||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.12
74003211|NCT00710021|147555447|SUPERIORITY_OR_OTHER|||||||0.31||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.||||||0.31
74037647|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.966|TWO_SIDED|95.0|-7.4|7.7|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||7.7|-7.4|0.966
73877948|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.075|||<|0.001|TWO_SIDED|95.0|0.036|0.113|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.113|0.036|<0.001
73877949|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.085|0.163|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.163|0.085|<0.001
74003212|NCT00710021|147555448|SUPERIORITY_OR_OTHER|||||||0.019||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.||||||0.019
74003213|NCT00710021|147555449|SUPERIORITY_OR_OTHER|||||||0.28||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.||||||0.28
74003214|NCT00710021|147555450|SUPERIORITY_OR_OTHER|||||||0.05||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.||||||0.050
74003215|NCT00710021|147555451|SUPERIORITY_OR_OTHER|||||||0.29||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.||||||0.29
74003216|NCT00710021|147555452|SUPERIORITY_OR_OTHER|||||||0.014||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.||||||0.014
74003217|NCT00710021|147555453|SUPERIORITY_OR_OTHER|||||||0.96||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.||||||0.96
74003218|NCT00710021|147555454|SUPERIORITY_OR_OTHER|||||||0.67||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.||||||0.67
74003219|NCT00710021|147555455|SUPERIORITY_OR_OTHER|||||||0.59||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.||||||0.59
74003220|NCT00710021|147555456|SUPERIORITY_OR_OTHER|||||||0.65||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.||||||0.65
74003221|NCT00710021|147555457|SUPERIORITY_OR_OTHER|||||||0.86||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.86
74003222|NCT00710021|147555458|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
74037648|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|9.5||||0.012|TWO_SIDED|95.0|2.1|16.9|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||16.9|2.1|0.012
74037649|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.233|TWO_SIDED|95.0|-2.5|10.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.1|-2.5|0.233
74037650|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|5.1||||0.113|TWO_SIDED|95.0|-1.2|11.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.4|-1.2|0.113
74037651|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.12|TWO_SIDED|95.0|-1.3|11.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||11.2|-1.3|0.120
74037652|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.691|TWO_SIDED|95.0|-5.1|7.6|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.6|-5.1|0.691
74003223|NCT00710021|147555459|SUPERIORITY_OR_OTHER|||||||0.62||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline SELENA-SLEDAI score.||||||0.62
74003224|NCT00710021|147555460|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
74003225|NCT00710021|147555461|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
74003226|NCT00710021|147555462|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
74003227|NCT00710021|147555463|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
74003228|NCT00710021|147555464|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
74037653|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.722|TWO_SIDED|95.0|-5.2|7.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.5|-5.2|0.722
74037654|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.966|TWO_SIDED|95.0|-6.5|6.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.2|-6.5|0.966
74090975|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.1242|||TWO_SIDED|95.0|-2.7|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-2.7|
74003229|NCT00710021|147555465|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
74003230|NCT00710021|147555466|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
73877950|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.152|||<|0.001|TWO_SIDED|95.0|0.113|0.19|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.190|0.113|<0.001
74003231|NCT00710021|147555467|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
74003232|NCT00710021|147555468|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
73877951|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.163|||<|0.001|TWO_SIDED|95.0|0.124|0.202|||MMRM|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.202|0.124|<0.001
74003233|NCT00710021|147555469|SUPERIORITY_OR_OTHER|||||||0.1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Cochran-Mantel-Haenszel|Note that none of the Grade 3 or above events were considered by the investigators to be related to study treatment.||||||0.10
74008889|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.795||||0.462|TWO_SIDED|95.0|0.431|1.465|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 2||1.465|0.431|0.462
74008890|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.726||||0.297|TWO_SIDED|95.0|0.399|1.324|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 2||1.324|0.399|0.297
74008891|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.688||||0.194|TWO_SIDED|95.0|0.391|1.21|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 3||1.210|0.391|0.194
74008892|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.732||||0.272|TWO_SIDED|95.0|0.419|1.277|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 3||1.277|0.419|0.272
74008893|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.748||||0.313|TWO_SIDED|95.0|0.426|1.314|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 4||1.314|0.426|0.313
74008894|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.663||||0.157|TWO_SIDED|95.0|0.376|1.171|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 4||1.171|0.376|0.157
74008895|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.072|TWO_SIDED|95.0|0.319|1.05|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 6||1.050|0.319|0.072
74008896|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.135|TWO_SIDED|95.0|0.356|1.149|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 6||1.149|0.356|0.135
74008897|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.465||||0.017|TWO_SIDED|95.0|0.249|0.871|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 8||0.871|0.249|0.017
74008898|NCT01372150|147568160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.751||||0.343|TWO_SIDED|95.0|0.415|1.357|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 8||1.357|0.415|0.343
74008899|NCT04422990|147568177|NON_INFERIORITY|Noninferiority in mean CLCDVA was declared if the upper confidence limit was less than 0.10 logMAR.|Least squares mean difference|0.0|||||TWO_SIDED|95.0|-0.01|0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Mixed effects repeated measures model||Least squares mean difference (LID018869 minus Biofinity).|||0.01|-0.01|
74008900|NCT04422990|147568178|NON_INFERIORITY|Proportion of subjects was used for the statistical analysis. Noninferiority in proportion of subjects achieving CLCDVA 20/20 or better in each eye was declared if the lower confidence limit was greater than -0.10.|Difference in proportion|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Generalized linear mixed model||Lens difference (LID018869 minus Biofinity)|||0.02|-0.04|
74003234|NCT03581825|147555470|SUPERIORITY|Statistically superiority was concluded if the lower limit of the confidence intervals of the Test lens are greater than 40 points.|Least-Square Mean|56.3|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|95.0|51.2|61.4|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||61.4|51.2|
74003235|NCT03581825|147555471|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control was concluded if the lower confidence limit of LSM difference was above the non-inferiority margin -5.|Least-Square Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-0.5|7.4|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||7.4|-0.5|
74003236|NCT00511901|147555472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
74003237|NCT00511901|147555473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||1||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 3 weeks||||1.00
74003238|NCT00511901|147555473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 8 weeks||||0.17
74003239|NCT00511901|147555473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.59||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 12 weeks||||0.59
74003240|NCT00511901|147555474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
74003241|NCT00511901|147555475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 3 weeks||||0.66
74003242|NCT00511901|147555475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 8 weeks||||1.00
74003243|NCT00511901|147555475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.53||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 12 weeks||||0.53
74003244|NCT00511901|147555476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.96||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 3 weeks||||0.96
74003245|NCT00511901|147555476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||1||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 8 weeks||||1.00
74003246|NCT00511901|147555476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 12 weeks||||0.66
74003247|NCT00511901|147555477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.64||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 3 weeks||||0.64
74003248|NCT00511901|147555477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.83||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 8 weeks||||0.83
74003249|NCT00511901|147555477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 12 weeks||||0.46
74003250|NCT00511901|147555478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.57||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 3 weeks||||0.37
74003251|NCT00511901|147555478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.39||||0.69||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 8 weeks||||0.69
74003252|NCT00511901|147555478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.15||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 12 weeks||||0.36
74003253|NCT00511901|147555479|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.5||||0.97||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 3 weeks||||0.97
74003254|NCT00511901|147555479|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 8 weeks||||0.46
74003255|NCT00511901|147555479|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.68||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 12 weeks||||0.68
74003256|NCT00529958|147555491|EQUIVALENCE|The sample size calculation was based on 88 ACL-deficient patients with surgical intervention and an ACL-QOL score of 74.5 (SD=20.1) at a mean 39-month follow-up, a minimal clinically important difference of 10 points, power=0.80 and p=0.05.|||||<|0.05||||||A Bonferroni adjustment for multiple comparisons was used in the sample size calculation, resulting in 90 patients per group. With a 20% lost-to-follow-up rate, the final sample size was 108 patients per group for a total of 324 patients.|Mixed Models Analysis|||"All patients were analyzed on an intention-to-treat basis using a 5% significance level for all analyses. The ACL-QOL scores for each study group were analyzed using adjusted Bonferroni comparisons and repeated-measures analyses, using a mixed-model analysis of variance for treatment group over time of assessment."||||<0.05
74003257|NCT03316300|147555504|SUPERIORITY||Mean Difference (Final Values)|-0.091|STANDARD_ERROR_OF_MEAN|0.0176|<|0.0001|TWO_SIDED|95.0|-0.13|-0.06|||Mixed Models Analysis|||||-0.06|-0.13|<0.0001
74008901|NCT00240981|147568196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|129.8||||0.003|TWO_SIDED|95.0|43.9|215.6||The unadjusted analysis using two-sample Student's t-tests of equal change in the trial groups, allowing unequal variance.|t-test, 2 sided|||||215.6|43.9|0.003
74008902|NCT00240981|147568196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|129.4||||0.004|TWO_SIDED|95.0|43.5|215.4||Adjusted analysis used multiple linear regression, with adjustment for baseline total score on the Short Physical Performance Battery, and self-report of limitations in mobility.|Regression, Linear|||||215.4|43.5|0.004
74008903|NCT00240981|147568197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.5||||0.002|TWO_SIDED|95.0|13.2|55.8||Unadjusted|t-test, 2 sided|||||55.8|13.2|0.002
74008904|NCT00240981|147568197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.5||||0.002|TWO_SIDED|95.0|13.1|56.2||Adjusted|Regression, Linear|||||56.2|13.1|0.002
74008905|NCT00240981|147568198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7||||0.34|TWO_SIDED|95.0|-9.2|26.7||Unadjusted|t-test, 2 sided|||||26.7|-9.2|0.34
74008906|NCT00240981|147568198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.1||||0.37|TWO_SIDED|95.0|-9.9|26.2||Adjusted.|Regression, Linear|||||26.2|-9.9|0.37
74008907|NCT00240981|147568199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.69|TWO_SIDED|95.0|-1.1|1.7||Unadjusted|t-test, 2 sided|||||1.7|-1.1|0.69
74008908|NCT00240981|147568199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26||||0.71|TWO_SIDED|95.0|-1.1|1.7||Adjusted.|Regression, Linear|||||1.7|-1.1|0.71
74008909|NCT00240981|147568200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.26|TWO_SIDED|95.0|-0.035|0.135||Unadjusted.|t-test, 2 sided|||||0.135|-0.035|0.26
74008910|NCT00240981|147568200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.048||||0.27|TWO_SIDED|95.0|-0.037|0.133||Adjusted|Regression, Linear|||||0.133|-0.037|0.27
74008911|NCT00240981|147568201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|30.2||||0.05|TWO_SIDED|95.0|0.3|60.1||Unadjusted.|t-test, 2 sided|||||60.1|0.3|0.05
74008912|NCT00240981|147568201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|29.7||||0.05|TWO_SIDED|95.0|0.2|59.3||Adjusted|Regression, Linear|||||59.3|0.2|0.05
74003258|NCT01315353|147555507|SUPERIORITY|Confidence interval estimation was stratified by ART use at screening using Greenwood's variance with the inverse of this variance used for the stratum weights.|Cumulative rate difference|1.7|||||ONE_SIDED|95.0|-7.9||||||The lower bound of the (lower) one-sided 95% confidence interval was provided.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN2+ with 95% one-sided confidence interval.|||-7.9|
74003259|NCT01315353|147555508|OTHER|||||||0.94||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Log Rank|Log-rank test was stratified by ART use at screening.||Null Hypothesis: There is no difference between Arm A and Arm B with respect to time to CIN2+.||||0.94
74003260|NCT01315353|147555509|OTHER||Cumulative rate difference|4.4|||||TWO_SIDED|95.0|-4.8|13.6|||||Confidence interval estimation was stratified by ART use at screening using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN3+ with 95% two-sided confidence interval.||13.6|-4.8|
74003261|NCT01315353|147555510|OTHER|||||||0.445||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null hypothesis: There is no difference between Arm A and Arm B with respect to rate of premature study discontinuation.||||0.445
74003262|NCT01315353|147555511|OTHER|||||||1||||||P-value for the week 26 comparison. The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 26.||||1.000
74003263|NCT01315353|147555511|OTHER|||||||0.279||||||"P-value for the week 52 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between the Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 52.||||0.279
74003264|NCT01315353|147555511|OTHER|||||||0.781||||||"P-value for the week 78 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 78.||||0.781
74003265|NCT01315353|147555511|OTHER|||||||0.375||||||"P-value for the week 104 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 104.||||0.375
74003266|NCT01315353|147555511|OTHER|||||||0.444||||||"P-value for the week 130 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 130.||||0.444
74003267|NCT01315353|147555512|OTHER|||||||0.132||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||0.132
74003268|NCT01315353|147555513|OTHER|||||||0.227||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||0.227
74003269|NCT01315353|147555514|OTHER|||||||1||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||1.000
74008913|NCT00240981|147568203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.2|TWO_SIDED|95.0|1.2|2.5||Month 3 Measures|t-test, 2 sided|||||2.5|1.2|0.2
74008914|NCT00240981|147568203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|||<|0.0001|TWO_SIDED|95.0|0.4|2.2||Month 6 Measures|t-test, 2 sided|||||2.2|0.4|<.0001
74008915|NCT00240981|147568204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.002|TWO_SIDED|95.0|-2.7|-0.6||3 Months Measures|t-test, 2 sided|||||-0.6|-2.7|0.002
74008916|NCT00240981|147568204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.2||6 Month Measures|t-test, 2 sided|||||-1.2|-2.8|<.0001
74008917|NCT00240981|147568205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074||||0.24|TWO_SIDED|95.0|-0.05|0.19||Unadjusted.|t-test, 2 sided|||||0.19|-0.05|0.24
74008918|NCT00240981|147568205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.14|TWO_SIDED|95.0|-0.03|0.209||Adjusted.|Regression, Linear|||||0.209|-0.030|0.14
74008919|NCT00766090|147568211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.064|0.153|||ANCOVA|||||0.153|0.064|<0.001
74008920|NCT00766090|147568211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|||<|0.001|TWO_SIDED|95.0|0.054|0.142|||ANCOVA|||||0.142|0.054|<0.001
74008921|NCT00766090|147568211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087||||0.02|TWO_SIDED|95.0|0.014|0.161|||ANCOVA|||||0.161|0.014|0.020
74008922|NCT00766090|147568211|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance level) for the mean difference in trough FEV1 of FF 200 µg OD versus FF 100 µg BID was greater than -110 milliliters.|Mean Difference (Final Values)|0.011||||0.641|TWO_SIDED|95.0|-0.035|0.056|||ANCOVA|||||0.056|-0.035|0.641
74008923|NCT00766090|147568211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|||<|0.001|TWO_SIDED|95.0|0.059|0.205|||ANCOVA|||||0.205|0.059|<0.001
74008924|NCT01750931|147568223|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.45||||0.4396|TWO_SIDED|95.0|99.4|105.59|||ANOVA|||||105.59|99.40|0.4396
74090976|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.124|||TWO_SIDED|95.0|-3.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.2|
74090977|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.1238|||TWO_SIDED|95.0|-3.7|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.7|
74090978|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.06|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.3|
74090979|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
74090980|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
74003270|NCT03567434|147555517|SUPERIORITY|The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.283||||||The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||Statistical analysis on Burst Frequency (Burst/Min)||||0.283
74003271|NCT03567434|147555517|SUPERIORITY|The original hypothesis was that resting MSNA burst incidence would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.92||||||The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||Statistical analysis on Burst Incidence (Burst/100hb)||||0.920
74003272|NCT03567434|147555519|SUPERIORITY|The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.888||||||The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||||||0.888
74003273|NCT02881957|147555538|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients as randomized (e.g., intent-to-treat) using a p\<0.05 as significant. Adverse events were monitored until discharge.||||0.2
74003274|NCT02881957|147555539|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.4
74003275|NCT02881957|147555540|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
74003276|NCT02881957|147555541|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
74003277|NCT02881957|147555542|SUPERIORITY|||||||0.7|||||||Chi-squared|||||||0.7
74003278|NCT02881957|147555543|SUPERIORITY|||||||0.99|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.99
74003279|NCT02881957|147555544|SUPERIORITY|||||||0.6|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.6
74003280|NCT02881957|147555545|SUPERIORITY|||||||0.7|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.7
74003281|NCT02881957|147555546|SUPERIORITY|||||||0.4|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.4
74003282|NCT02881957|147555547|SUPERIORITY|||||||0.1|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.1
74003283|NCT01880528|147555566|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
74003284|NCT01880528|147555567|SUPERIORITY|||||||0.0337|||||||Kruskal-Wallis|||||||0.0337
74003285|NCT01880528|147555568|SUPERIORITY|||||||0.0427|||||||Kruskal-Wallis|||||||0.0427
74003286|NCT01880528|147555569|SUPERIORITY|||||||0.0237|||||||Kruskal-Wallis|||||||0.0237
74003287|NCT01439360|147555570|SUPERIORITY_OR_OTHER||Vaccine efficacy (VE)|63.2|||||TWO_SIDED|97.5|51.8|72.3|||Regression, Cox|Adjusted for age category and stratified for cohort.|VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for vaccine efficacy (VE) is above (\>) 25%.||72.3|51.8|
74003288|NCT01439360|147555571|SUPERIORITY_OR_OTHER||Vaccine efficacy (VE)|49.8|||||TWO_SIDED|97.5|41.8|56.8|||Regression, Cox|Adjusted for age category and stratified for cohort|VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for VE is above 15%.||56.8|41.8|
74003289|NCT01786174|147555599|SUPERIORITY_OR_OTHER||Slope|1.4|STANDARD_ERROR_OF_MEAN|4.3||0.746|TWO_SIDED|95.0|-7.17|9.96|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||9.96|-7.17|0.746
74003290|NCT01786174|147555600|SUPERIORITY_OR_OTHER||Slope|0.25|STANDARD_ERROR_OF_MEAN|0.89||0.78|TWO_SIDED|95.0|-1.53|2.03|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||2.03|-1.53|0.780
74037655|NCT03084718|147628785|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.008|TWO_SIDED|95.0|2.2|14.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||14.5|2.2|0.008
74037656|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.426|TWO_SIDED|95.0|-3.4|7.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||7.9|-3.4|0.426
74037657|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.055|TWO_SIDED|95.0|-0.1|11.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.2|-0.1|0.055
74037658|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|5.4||||0.059|TWO_SIDED|95.0|-0.2|11.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||11.1|-0.2|0.059
74090981|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.1238|||TWO_SIDED|95.0|-3.7|0.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.7|-3.7|
74090982|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.124|||TWO_SIDED|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.3|
74003291|NCT01786174|147555601|SUPERIORITY_OR_OTHER||Slope|-0.51|STANDARD_ERROR_OF_MEAN|2.26||0.823|TWO_SIDED|95.0|-5.0|3.99|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||3.99|-5.00|0.823
74037659|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.263|TWO_SIDED|95.0|-2.5|9.0|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.0|-2.5|0.263
74003292|NCT01786174|147555603|SUPERIORITY_OR_OTHER||Slope|4.27|STANDARD_ERROR_OF_MEAN|4.04||0.294|TWO_SIDED|95.0|-3.78|12.33|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||12.33|-3.78|0.294
74003293|NCT04281004|147555608|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
74003294|NCT04281004|147555609|SUPERIORITY|||||||0.869|||||||Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.869
74003295|NCT04281004|147555610|SUPERIORITY|||||||0.007||||||Significance of treatment effect at month 1.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.007
74003296|NCT04281004|147555610|SUPERIORITY|||||||0.953||||||Significance of treatment effect at month 3.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.953
74003297|NCT04281004|147555610|SUPERIORITY|||||||0.841||||||Significance of treatment effect at month 6.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.841
74003298|NCT04281004|147555610|SUPERIORITY|||||||0.137||||||Significance of treatment effect at month 12.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.137
74037660|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.28|TWO_SIDED|95.0|-2.6|8.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.8|-2.6|0.280
74003299|NCT04281004|147555611|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
74003300|NCT04281004|147555612|SUPERIORITY|||||||0.594|||||||Fisher Exact|||||||0.594
74003301|NCT04281004|147555613|SUPERIORITY|||||||0.663||||||Significance of treatment effect at month 1.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.663
74003302|NCT04281004|147555613|SUPERIORITY|||||||0.416||||||Significance of treatment effect at month 3.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.416
74037661|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.965|TWO_SIDED|95.0|-5.9|5.6|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||5.6|-5.9|0.965
74037662|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.007|TWO_SIDED|95.0|2.2|13.3|||Mixed Models Analysis|||"Inter-visit period 1~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.3|2.2|0.007
74003303|NCT04281004|147555613|SUPERIORITY|||||||0.89||||||Significance of treatment effect at month 6.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.890
74003304|NCT04281004|147555613|SUPERIORITY|||||||0.192||||||Significance of treatment effect at month 12.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.192
74003305|NCT04281004|147555614|SUPERIORITY|||||||0.057||||||Significance of treatment effect at month 1.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.057
74003306|NCT04281004|147555614|SUPERIORITY|||||||0.528||||||Significance of treatment effect at month 3.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.528
74003307|NCT04281004|147555614|SUPERIORITY|||||||0.21||||||Significance of treatment effect at month 6.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.210
74003308|NCT04281004|147555614|SUPERIORITY|||||||0.853||||||Significance of treatment effect at month 12.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.853
74003309|NCT02482870|147555638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Chi-squared|Chi-square value = 2.424; degrees of freedom = 1||Sample size was calculated according to the first 60 patients. To obtain 90% power with an alpha error of 0.05, a total of 378 patients were required. Considering a possible drop-out rate of 2.5% due to unexpected complications, we aimed for 388 patients.||||0.119
74003310|NCT02482870|147555639|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||<|0.0001|TWO_SIDED|95.0|3.0|4.6||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||4.6|3|<0.0001
74003311|NCT02482870|147555640|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.9|||<|0.0001|TWO_SIDED|95.0|0.5|1.4||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||1.4|0.5|<0.0001
74037663|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.308|TWO_SIDED|95.0|-3.5|11.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.2|-3.5|0.308
74037664|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|5.8||||0.124|TWO_SIDED|95.0|-1.6|13.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.2|-1.6|0.124
74037665|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.063|TWO_SIDED|95.0|-0.4|14.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||14.3|-0.4|0.063
74037666|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.602|TWO_SIDED|95.0|-5.5|9.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.4|-5.5|0.602
74003312|NCT02482870|147555641|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.67||A priori threshold for statistical significance was 0.05.|t-test, 2 sided|t value = -11.224, degrees of freedom = 773.99||"For each patient, the difference between Cormack-Lehane score and Mallampati class was calculated for each laryngoscope. As an example, the first patient had a Mallampati score 3. Macintosh laryngoscope provided a Cormack-Lehane score of 2, therefore the difference is - 1, calculated as 2 - 3. In the same patient, King Vision video laryngoscope provided a Cormack-Lehane score of 1, therefore the difference is - 2, calculated as 1 - 3. T-test was used to compare the differences."||-0.67|-0.95|<0.0001
74003313|NCT02482870|147555642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Chi-squared, Corrected|Chi-square test with Yates' continuity correction: chi-square = 0.101; degrees of freedom = 1||||||0.75
74003314|NCT01620255|147555643|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.08||||0.0213|TWO_SIDED|90.0|0.019|0.14||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg versus (vs) placebo, centrally read||0.140|0.019|0.0213
74003315|NCT01620255|147555643|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.128||||0.0025|TWO_SIDED|90.0|0.056|0.199||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.199|0.056|0.0025
74037667|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.402|TWO_SIDED|95.0|-4.3|10.6|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||10.6|-4.3|0.402
74003316|NCT01620255|147555643|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.118||||0.004|TWO_SIDED|90.0|0.048|0.188||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.188|0.048|0.0040
74003317|NCT01620255|147555643|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.026||||0.1803|TWO_SIDED|90.0|-0.012|0.064||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.064|-0.012|0.1803
74003318|NCT01620255|147555643|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.08||||0.0582|TWO_SIDED|90.0|0.002|0.159||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.159|0.002|0.0582
74037668|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.753|TWO_SIDED|95.0|-6.3|8.6|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||8.6|-6.3|0.753
74037669|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|10.2||||0.006|TWO_SIDED|95.0|2.9|17.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||17.4|2.9|0.006
74037670|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.331|TWO_SIDED|95.0|-3.1|9.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||9.2|-3.1|0.331
74037671|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.073|TWO_SIDED|95.0|-0.5|11.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.9|-0.5|0.073
74037672|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.048|TWO_SIDED|95.0|0.1|12.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.4|0.1|0.048
74037673|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|2.6||||0.41|TWO_SIDED|95.0|-3.6|8.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.9|-3.6|0.410
74037674|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.32|TWO_SIDED|95.0|-3.1|9.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.4|-3.1|0.320
74037675|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.867|TWO_SIDED|95.0|-5.7|6.8|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.8|-5.7|0.867
74037676|NCT03084718|147628786|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.004|TWO_SIDED|95.0|2.9|15.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||15.0|2.9|0.004
74037677|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.26|TWO_SIDED|95.0|-3.2|11.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.9|-3.2|0.260
74037678|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.387|TWO_SIDED|95.0|-4.2|10.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||10.9|-4.2|0.387
74090983|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.1242|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
74090984|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.35|STANDARD_ERROR_OF_MEAN|1.0986|||TWO_SIDED|95.0|-2.5|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-2.5|
74090985|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.0985|||TWO_SIDED|95.0|-4.5|-0.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.2|-4.5|
74037679|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.574|TWO_SIDED|95.0|-5.4|9.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||9.7|-5.4|0.574
74037680|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.799|TWO_SIDED|95.0|-8.6|6.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.7|-8.6|0.799
74037681|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.577|TWO_SIDED|95.0|-9.8|5.5|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||5.5|-9.8|0.577
74037682|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.764|TWO_SIDED|95.0|-8.8|6.5|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.5|-8.8|0.764
74037683|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.097|TWO_SIDED|95.0|-1.1|13.8|||Mixed Models Analysis|||"Inter-visit period 1~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.8|-1.1|0.097
74037684|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.908|TWO_SIDED|95.0|-9.9|8.8|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||8.8|-9.9|0.908
74037685|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.135|TWO_SIDED|95.0|-2.2|16.5|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||16.5|-2.2|0.135
74037686|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.786|TWO_SIDED|95.0|-10.7|8.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo"||8.1|-10.7|0.786
74037687|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.109|TWO_SIDED|95.0|-1.7|17.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||17.1|-1.7|0.109
74090986|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.39|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.6|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.6|
74090987|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.38|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.5|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.5|
74003319|NCT01620255|147555643|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.178||||0.0014|TWO_SIDED|90.0|0.083|0.272||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.272|0.083|0.0014
74003320|NCT01620255|147555643|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.122||||0.0125|TWO_SIDED|90.0|0.036|0.208||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.208|0.036|0.0125
74003321|NCT01620255|147555643|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.066||||0.0927|TWO_SIDED|90.0|-0.009|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.142|-0.009|0.0927
74003322|NCT01620255|147555644|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.089||||0.1379|TWO_SIDED|90.0|-0.037|0.214||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read||0.214|-0.037|0.1379
74003323|NCT01620255|147555644|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.254||||0.0011|TWO_SIDED|90.0|0.121|0.388||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.388|0.121|0.0011
74003324|NCT01620255|147555644|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.163||||0.0239|TWO_SIDED|90.0|0.032|0.293||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.293|0.032|0.0239
74003325|NCT01620255|147555644|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.213||||0.0052|TWO_SIDED|90.0|0.08|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.347|0.080|0.0052
74003326|NCT01620255|147555644|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.056||||0.2617|TWO_SIDED|90.0|-0.075|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.186|-0.075|0.2617
74003327|NCT01620255|147555644|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.212||||0.0058|TWO_SIDED|90.0|0.077|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.347|0.077|0.0058
74003328|NCT01620255|147555644|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.156||||0.0326|TWO_SIDED|90.0|0.022|0.29||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.290|0.022|0.0326
74003329|NCT01620255|147555644|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.185||||0.0145|TWO_SIDED|90.0|0.05|0.32||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.320|0.050|0.0145
74003330|NCT01620255|147555645|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.081||||0.0618|TWO_SIDED|90.0|0.0|0.162||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read||0.162|0.000|0.0618
74003331|NCT01620255|147555645|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.187||||0.0009|TWO_SIDED|90.0|0.091|0.284||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.284|0.091|0.0009
74003332|NCT01620255|147555645|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.159||||0.0027|TWO_SIDED|90.0|0.068|0.25||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.250|0.068|0.0027
74003333|NCT01620255|147555645|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.069||||0.0999|TWO_SIDED|90.0|-0.013|0.151||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.151|-0.013|0.0999
74003334|NCT01620255|147555645|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.001||||0.5225|TWO_SIDED|90.0|-0.111|0.114||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.114|-0.111|0.5225
74037688|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.876|TWO_SIDED|95.0|-10.1|8.7|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.7|-10.1|0.876
74037689|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|-8.0||||0.08|TWO_SIDED|95.0|-17.9|1.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||1.0|-17.9|0.080
74037690|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.202|TWO_SIDED|95.0|-3.2|15.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||15.3|-3.2|0.202
74037691|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.635|TWO_SIDED|95.0|-5.9|9.7|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||9.7|-5.9|0.635
74037692|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.191|TWO_SIDED|95.0|-2.6|13.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.1|-2.6|0.191
74037693|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.914|TWO_SIDED|95.0|-7.4|8.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||8.3|-7.4|0.914
74037694|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.407|TWO_SIDED|95.0|-4.6|11.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||11.3|-4.6|0.407
74037695|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.718|TWO_SIDED|95.0|-9.4|6.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.4|-9.4|0.718
74037696|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.235|TWO_SIDED|95.0|-12.7|3.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||3.1|-12.7|0.235
74037697|NCT03084718|147628787|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.118|TWO_SIDED|95.0|-1.6|13.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.9|-1.6|0.118
74037698|NCT03341923|147628794|NON_INFERIORITY|"Difference (DT1MF-AMMF) of percentage of subjects rated as Optimal was provided with two-sided 95% confidence interval (CI). If lower limit of CI was above -10% as non-inferiority criteria, non-inferiority was to be demonstrated."|Difference in proportion|6.1||||0.0455|TWO_SIDED|95.0|0.2|11.9|||McNemar|||||11.9|0.2|0.0455
74037699|NCT03341923|147628794|SUPERIORITY|After demonstrating noninferiority, if lower limit of CI was above 0% as superiority criteria, superiority was to be demonstrated.|Difference in proportion|6.1||||0.0455|TWO_SIDED|95.0|0.2|11.9|||McNemar|||||11.9|0.2|0.0455
74037700|NCT02767856|147628853|EQUIVALENCE|The study did not enroll enough samples. The stats here are only for reference.|Mean Difference (Net)|0.04||||0.48|TWO_SIDED|95.0|-0.08|0.16|||t-test, 2 sided|||Baseline and primary visit outcome||0.16|-0.08|0.48
74037701|NCT02767856|147628854|EQUIVALENCE|The study did not reach the target sample size. the stats are for reference.|Mean Difference (Final Values)|0.12||||0.26|TWO_SIDED|95.0|-0.75|0.99|||t-test, 2 sided|||||0.99|-0.75|0.26
74037702|NCT02767856|147628855|EQUIVALENCE|The study did not reach the target sample size. The stats are for reference.|Mean Difference (Final Values)|26.3||||0.26|TWO_SIDED|95.0|-21.75|74.2|||t-test, 2 sided|||||74.20|-21.75|0.26
74003335|NCT01620255|147555645|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.154||||0.0246|TWO_SIDED|90.0|0.03|0.278||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.278|0.030|0.0246
74003336|NCT01620255|147555645|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.13||||0.0464|TWO_SIDED|90.0|0.008|0.253||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.253|0.008|0.0464
74037703|NCT02767856|147628856|EQUIVALENCE|The study did not reach the target sample size. The stats are for reference.|Mean Difference (Final Values)|11.1||||0.44|TWO_SIDED|95.0|-41.3|19.3|||t-test, 2 sided|||||19.3|-41.3|0.44
74037704|NCT00424294|147628857|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||Chi-squared|||||||0.733
74037705|NCT00424294|147628858|SUPERIORITY_OR_OTHER|||||||0.463|TWO_SIDED||||||Chi-squared|||Week 1: p-value was calculated by Chi-square test.||||0.463
74037706|NCT00424294|147628858|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Chi-squared|||Week 2: p-value was calculated by Chi-square test.||||0.549
74037707|NCT00424294|147628858|SUPERIORITY_OR_OTHER|||||||0.272|TWO_SIDED||||||Chi-squared|||Week 4: p-value was calculated by Chi-square test.||||0.272
74037708|NCT00424294|147628858|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Chi-squared|||Week 8: p-value was calculated by Chi-square test.||||0.265
74037709|NCT00424294|147628859|SUPERIORITY_OR_OTHER|||||||0.939|TWO_SIDED||||||Fisher Exact|||Week 4: p-value was calculated by Fisher exact test.||||0.939
74037710|NCT00424294|147628859|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Fisher Exact|||Week 8: p-value was calculated by Fisher exact test.||||0.323
74037711|NCT00424294|147628859|SUPERIORITY_OR_OTHER|||||||0.338|TWO_SIDED||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.||||0.338
74037712|NCT00424294|147628860|SUPERIORITY_OR_OTHER|||||||0.746|TWO_SIDED||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.||||0.746
74037713|NCT00424294|147628861|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED||||||ANCOVA|||Week 1: Analysis of covariance (ANCOVA) with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.635
74003337|NCT01620255|147555645|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.066||||0.2|TWO_SIDED|90.0|-0.053|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.186|-0.053|0.2000
74003338|NCT01620255|147555647|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean (LSM) Difference|-0.88||||0.0494|TWO_SIDED|90.0|-1.623|-0.145|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, centrally read change||-0.145|-1.623|0.0494
74003339|NCT01620255|147555647|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.53||||0.0005|TWO_SIDED|90.0|-2.254|-0.809|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, centrally read change||-0.809|-2.254|0.0005
74003340|NCT01620255|147555647|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.12||||0.0117|TWO_SIDED|90.0|-1.845|-0.39|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, centrally read change||-0.390|-1.845|0.0117
74003341|NCT01620255|147555647|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.27||||0.0049|TWO_SIDED|90.0|-2.016|-0.533|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, centrally read change||-0.533|-2.016|0.0049
74003342|NCT01620255|147555647|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.94||||0.0543|TWO_SIDED|90.0|-1.737|-0.137|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, locally read change||-0.137|-1.737|0.0543
74003343|NCT01620255|147555647|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.6||||0.0008|TWO_SIDED|90.0|-2.372|-0.819|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, locally read change||-0.819|-2.372|0.0008
74003344|NCT01620255|147555647|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.07||||0.0255|TWO_SIDED|90.0|-1.858|-0.284|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, locally read change||-0.284|-1.858|0.0255
74037714|NCT00424294|147628861|SUPERIORITY_OR_OTHER|||||||0.044|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.044
74037715|NCT00424294|147628861|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.957
74003345|NCT01620255|147555647|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.29||||0.0079|TWO_SIDED|90.0|-2.082|-0.493|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, locally read change||-0.493|-2.082|0.0079
74003346|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.1016|TWO_SIDED|90.0|-0.511|0.001|||Mixed Models Analysis|Linear Mixed Model (LMM) with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W4||0.001|-0.511|0.1016
74003347|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.28||||0.0654|TWO_SIDED|90.0|-0.529|-0.03|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W4||-0.030|-0.529|0.0654
74003348|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.15|TWO_SIDED|90.0|-0.472|0.031|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W4||0.031|-0.472|0.1500
74003349|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.38||||0.0132|TWO_SIDED|90.0|-0.637|-0.129|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W4||-0.129|-0.637|0.0132
74003350|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.3||||0.0526|TWO_SIDED|90.0|-0.555|-0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W8||-0.046|-0.555|0.0526
74003351|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.31||||0.0422|TWO_SIDED|90.0|-0.554|-0.058|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W8||-0.058|-0.554|0.0422
74003352|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.39||||0.011|TWO_SIDED|90.0|-0.637|-0.137|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W8||-0.137|-0.637|0.0110
74003353|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.5||||0.001|TWO_SIDED|90.0|-0.755|-0.254|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W8||-0.254|-0.755|0.0010
74003354|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.1611|TWO_SIDED|90.0|-0.475|0.038|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W12||0.038|-0.475|0.1611
74003355|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.36||||0.0186|TWO_SIDED|90.0|-0.608|-0.108|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W12||-0.108|-0.608|0.0186
74037716|NCT00424294|147628861|SUPERIORITY_OR_OTHER|||||||0.597|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.597
74037717|NCT00424294|147628861|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.960
74003356|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.21||||0.1647|TWO_SIDED|90.0|-0.465|0.039|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W12||0.039|-0.465|0.1647
74003357|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.35||||0.0231|TWO_SIDED|90.0|-0.607|-0.097|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W12||-0.097|-0.607|0.0231
74003358|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.46||||0.0002|TWO_SIDED|90.0|-0.658|-0.26|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W4||-0.260|-0.658|0.0002
74003359|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.52|||<|0.0001|TWO_SIDED|90.0|-0.71|-0.322|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W4||-0.322|-0.710|<0.0001
74003360|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.49|||<|0.0001|TWO_SIDED|90.0|-0.686|-0.295|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W4||-0.295|-0.686|<0.0001
74037718|NCT00424294|147628862|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.252
74037719|NCT00424294|147628862|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.032
74037720|NCT00424294|147628862|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.031
74037721|NCT00424294|147628862|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.018
74037722|NCT00424294|147628862|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.170
74037723|NCT00424294|147628863|SUPERIORITY_OR_OTHER|||||||0.507|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.507
74037724|NCT00424294|147628863|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.743
74037725|NCT00424294|147628863|SUPERIORITY_OR_OTHER|||||||0.914|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.914
73877952|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.485|TWO_SIDED|95.0|-0.025|0.052|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.052|-0.025|0.485
74003361|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.39||||0.0012|TWO_SIDED|90.0|-0.587|-0.192|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W4||-0.192|-0.587|0.0012
74003362|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.28||||0.0207|TWO_SIDED|90.0|-0.475|-0.081|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W8||-0.081|-0.475|0.0207
74003363|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.24||||0.0402|TWO_SIDED|90.0|-0.432|-0.048|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W8||-0.048|-0.432|0.0402
74003364|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.32||||0.0071|TWO_SIDED|90.0|-0.511|-0.124|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W8||-0.124|-0.511|0.0071
74003365|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.47|||<|0.0001|TWO_SIDED|90.0|-0.664|-0.275|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W8||-0.275|-0.664|<0.0001
74003366|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0395|TWO_SIDED|90.0|-0.449|-0.05|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W12||-0.050|-0.449|0.0395
74037726|NCT00424294|147628863|SUPERIORITY_OR_OTHER|||||||0.715|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.715
74037727|NCT00424294|147628863|SUPERIORITY_OR_OTHER|||||||0.558|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.558
74037728|NCT00424294|147628864|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.172
74037729|NCT00424294|147628864|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.738
74037730|NCT00424294|147628864|SUPERIORITY_OR_OTHER|||||||0.948|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.948
74037731|NCT00424294|147628864|SUPERIORITY_OR_OTHER|||||||0.428|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.428
74037732|NCT00424294|147628864|SUPERIORITY_OR_OTHER|||||||0.861|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.861
74003367|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.32||||0.0073|TWO_SIDED|90.0|-0.511|-0.123|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W12||-0.123|-0.511|0.0073
74003368|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.24||||0.0413|TWO_SIDED|90.0|-0.439|-0.047|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W12||-0.047|-0.439|0.0413
74003369|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.4||||0.0008|TWO_SIDED|90.0|-0.602|-0.206|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W12||-0.206|-0.602|0.0008
74003370|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.19||||0.1862|TWO_SIDED|90.0|-0.421|0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W4||0.046|-0.421|0.1862
74003371|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.0998|TWO_SIDED|90.0|-0.455|0.0|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W4||-0.000|-0.455|0.0998
74003372|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.1085|TWO_SIDED|90.0|-0.453|0.006|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W4||0.006|-0.453|0.1085
74003373|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.14||||0.3161|TWO_SIDED|90.0|-0.372|0.09|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W4||0.090|-0.372|0.3161
74003374|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.1||||0.4962|TWO_SIDED|90.0|-0.328|0.136|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W8||0.136|-0.328|0.4962
74003375|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.29||||0.0371|TWO_SIDED|90.0|-0.512|-0.06|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W8||-0.060|-0.512|0.0371
74003376|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.21||||0.1212|TWO_SIDED|90.0|-0.441|0.013|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W8||0.013|-0.441|0.1212
74003377|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.18||||0.187|TWO_SIDED|90.0|-0.41|0.045|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W8||0.045|-0.410|0.1870
74003378|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.1133|TWO_SIDED|90.0|-0.459|0.009|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W12||0.009|-0.459|0.1133
74003379|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.43||||0.0022|TWO_SIDED|90.0|-0.653|-0.198|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W12||-0.198|-0.653|0.0022
74003380|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0788|TWO_SIDED|90.0|-0.475|-0.016|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W12||-0.016|-0.475|0.0788
74003381|NCT01620255|147555648|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0717|TWO_SIDED|90.0|-0.485|-0.022|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W12||-0.022|-0.485|0.0717
74003382|NCT01620255|147555649|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.08||||0.5406|TWO_SIDED|90.0|-0.286|0.131|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo||0.131|-0.286|0.5406
74003383|NCT01620255|147555649|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.42||||0.0007|TWO_SIDED|90.0|-0.628|-0.221|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo||-0.221|-0.628|0.0007
74003384|NCT01620255|147555649|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.34||||0.0063|TWO_SIDED|90.0|-0.549|-0.137|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 75 mg vs placebo||-0.137|-0.549|0.0063
74003385|NCT01620255|147555649|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.0748|TWO_SIDED|90.0|-0.436|-0.018|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 225 mg vs placebo||-0.018|-0.436|0.0748
74003386|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.9||||0.9744|TWO_SIDED|90.0|-101.0|97.14|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4||97.14|-101.00|0.9744
74003387|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|74.9||||0.2023|TWO_SIDED|90.0|-21.77|171.66|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4||171.66|-21.77|0.2023
74003388|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|32.9||||0.5808|TWO_SIDED|90.0|-65.09|130.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4||130.79|-65.09|0.5808
74003389|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|37.6||||0.5388|TWO_SIDED|90.0|-63.12|138.34|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4||138.34|-63.12|0.5388
74037733|NCT00424294|147628865|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.325
74003390|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-8.2||||0.8902|TWO_SIDED|90.0|-106.24|89.81|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8||89.81|-106.24|0.8902
74003391|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|10.2||||0.8616|TWO_SIDED|90.0|-86.14|106.54|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8||106.54|-86.14|0.8616
74003392|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-34.3||||0.5684|TWO_SIDED|90.0|-133.49|64.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8||64.79|-133.49|0.5684
74037734|NCT00424294|147628865|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.386
74037735|NCT00424294|147628865|SUPERIORITY_OR_OTHER|||||||0.532|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.532
74037736|NCT00424294|147628865|SUPERIORITY_OR_OTHER|||||||0.909|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.909
74037737|NCT00424294|147628865|SUPERIORITY_OR_OTHER|||||||0.994|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.994
74037738|NCT00424294|147628866|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.369
74037739|NCT00424294|147628866|SUPERIORITY_OR_OTHER|||||||0.666|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.666
74037740|NCT00424294|147628866|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.530
74037741|NCT00424294|147628866|SUPERIORITY_OR_OTHER|||||||0.632|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.632
74037742|NCT00424294|147628866|SUPERIORITY_OR_OTHER|||||||0.801|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.801
74037743|NCT00424294|147628867|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.052
74037744|NCT00424294|147628867|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.108
74037745|NCT00424294|147628867|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.573
74037746|NCT00424294|147628867|SUPERIORITY_OR_OTHER|||||||0.342|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.342
74037747|NCT00424294|147628867|SUPERIORITY_OR_OTHER|||||||0.501|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.501
74037748|NCT00424294|147628868|SUPERIORITY_OR_OTHER|||||||0.701|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.701
74037749|NCT00424294|147628868|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.167
74037750|NCT00424294|147628868|SUPERIORITY_OR_OTHER|||||||0.948|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.948
74037751|NCT00424294|147628868|SUPERIORITY_OR_OTHER|||||||0.834|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.834
74037752|NCT00424294|147628868|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.977
74037753|NCT00424294|147628869|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.291
74037754|NCT00424294|147628869|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.080
74037755|NCT00424294|147628869|SUPERIORITY_OR_OTHER|||||||0.466|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.466
74037756|NCT00424294|147628869|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.267
74037757|NCT00424294|147628869|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.100
74037758|NCT04397718|147628881|SUPERIORITY||Odds Ratio (OR)|1.19||||0.667|TWO_SIDED|95.0|0.46|3.06|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD|||3.06|0.46|0.667
74037759|NCT04397718|147628882|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.876|TWO_SIDED|95.0|0.58|1.49|||Log Rank||Cox regression model adjusted for age, hypertension, and COPD.|||1.49|0.58|0.876
74037760|NCT04397718|147628883|SUPERIORITY||Odds Ratio (OR)|0.95||||0.991|TWO_SIDED|95.0|0.31|2.92|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD.|||2.92|0.31|0.991
74037761|NCT04397718|147628884|SUPERIORITY||Quantile Regression|0.0||||0.841|TWO_SIDED|95.0|-2.03|4.11|||Wilcoxon (Mann-Whitney)||Adjusted for age, hypertension, and COPD|||4.11|-2.03|0.841
74037762|NCT04397718|147628885|SUPERIORITY||Quantile Regression|0.0||||0.746|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||Adjusted for age, hypertension, and COPD|||0|0|0.746
74037763|NCT04397718|147628886|SUPERIORITY||Hazard Ratio (HR)|2.3||||0.1|TWO_SIDED|95.0|0.72|7.39|||Log Rank||Cox regression model adjusted for age, hypertension, and COPD|||7.39|0.72|0.1
74003393|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|33.8||||0.57|TWO_SIDED|90.0|-64.2|131.86|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8||131.86|-64.20|0.5700
74003394|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-30.0||||0.6234|TWO_SIDED|90.0|-130.56|70.57|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12||70.57|-130.56|0.6234
74003395|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|36.0||||0.5474|TWO_SIDED|90.0|-62.44|134.38|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12||134.38|-62.44|0.5474
74003396|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|78.5||||0.1918|TWO_SIDED|90.0|-20.48|177.56|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12||177.56|-20.48|0.1918
74003397|NCT01620255|147555650|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-3.0||||0.9615|TWO_SIDED|90.0|-104.88|98.91|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12||98.91|-104.88|0.9615
74037764|NCT04397718|147628887|SUPERIORITY||Odds Ratio (OR)|0.82||||0.425|TWO_SIDED|95.0|0.33|2.0|||Fisher Exact||||Logistical regression adjusted for age, hypertension, COPD, and baseline severity score.|2|0.33|0.425
74037765|NCT04397718|147628888|SUPERIORITY||Odds Ratio (OR)|1.22||||0.688|TWO_SIDED|95.0|0.44|3.42|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD.|||3.42|0.44|0.688
74037766|NCT01797965|147628905|SUPERIORITY|||||||0.5937|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 12||||0.5937
74037767|NCT01797965|147628905|SUPERIORITY|||||||0.6233|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 24||||0.6233
74090988|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15|STANDARD_ERROR_OF_MEAN|1.0983|||TWO_SIDED|95.0|-3.3|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.0|-3.3|
73877953|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.001|TWO_SIDED|95.0|0.025|0.102|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.102|0.025|0.001
74003398|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|6.4||||0.9328|TWO_SIDED|90.0|-118.6|131.41|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4||131.41|-118.60|0.9328
74003399|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-9.8||||0.8962|TWO_SIDED|90.0|-132.91|113.39|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4||113.39|-132.91|0.8962
74003400|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|11.5||||0.8775|TWO_SIDED|90.0|-110.83|133.74|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4||133.74|-110.83|0.8775
74003401|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-17.0||||0.8224|TWO_SIDED|90.0|-142.02|107.94|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4||107.94|-142.02|0.8224
74003402|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-52.7||||0.4831|TWO_SIDED|90.0|-176.48|71.02|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8||71.02|-176.48|0.4831
74003403|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-115.2||||0.1183|TWO_SIDED|90.0|-236.63|6.13|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8||6.13|-236.63|0.1183
74003404|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-115.8||||0.1139|TWO_SIDED|90.0|-236.29|4.69|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8||4.69|-236.29|0.1139
74037768|NCT01797965|147628905|SUPERIORITY|||||||0.1884|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 48||||0.1884
74003405|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-96.4||||0.1931|TWO_SIDED|90.0|-218.17|25.46|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8||25.46|-218.17|0.1931
74037769|NCT01797965|147628906|SUPERIORITY|||||||0.0204|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301||||0.0204
74037770|NCT01797965|147628906|SUPERIORITY|||||||0.0805|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301||||0.0805
74037771|NCT01797965|147628906|SUPERIORITY|||||||0.2535|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301||||0.2535
74037772|NCT01797965|147628906|SUPERIORITY|||||||0.4738|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301||||0.4738
74090989|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-2.8|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-2.8|
74090990|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.53|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-3.7|
74003406|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-119.7||||0.1182|TWO_SIDED|90.0|-245.66|6.32|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12||6.32|-245.66|0.1182
74003407|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-41.7||||0.5784|TWO_SIDED|90.0|-165.34|81.87|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12||81.87|-165.34|0.5784
74003408|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-163.6||||0.0279|TWO_SIDED|90.0|-285.84|-41.29|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12||-41.29|-285.84|0.0279
74003409|NCT01620255|147555651|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-123.5||||0.1053|TWO_SIDED|90.0|-249.0|1.93|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12||1.93|-249.00|0.1053
74003410|NCT01620255|147555652|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.1||||0.8302|TWO_SIDED|90.0|-9.507|7.317|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, change from BL at W12||7.317|-9.507|0.8302
74037773|NCT01797965|147628906|SUPERIORITY|||||||0.2302|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301||||0.2302
74037774|NCT01797965|147628906|SUPERIORITY|||||||0.8522|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301||||0.8522
74003411|NCT01620255|147555652|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|12.33||||0.0141|TWO_SIDED|90.0|4.084|20.567|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, change from BL at W12||20.567|4.084|0.0141
74003412|NCT01620255|147555652|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|11.7||||0.0182|TWO_SIDED|90.0|3.564|19.84|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, change from BL at W12||19.840|3.564|0.0182
74037775|NCT01797965|147628906|SUPERIORITY|||||||0.0431|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301||||0.0431
74003413|NCT01620255|147555652|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|15.48||||0.0026|TWO_SIDED|90.0|7.056|23.907|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, change from BL at W12||23.907|7.056|0.0026
74003414|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.73||||0.6862|TWO_SIDED|90.0|-3.689|2.235|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, bowel fx change from BL at W12||2.235|-3.689|0.6862
74003415|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.37||||0.0135|TWO_SIDED|90.0|1.467|7.28|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, bowel fx change from BL at W12||7.280|1.467|0.0135
74003416|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.16||||0.0171|TWO_SIDED|90.0|1.293|7.023|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, bowel fx change from BL at W12||7.023|1.293|0.0171
74003417|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|5.2||||0.0041|TWO_SIDED|90.0|2.232|8.172|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, bowel fx change from BL at W12||8.172|2.232|0.0041
74037776|NCT01797965|147628906|SUPERIORITY|||||||0.0339|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301||||0.0339
74037777|NCT01797965|147628906|SUPERIORITY|||||||0.3195|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301||||0.3195
74037778|NCT01797965|147628906|SUPERIORITY|||||||0.2119|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301||||0.2119
74090991|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.0985|||TWO_SIDED|95.0|-3.1|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.1|
74090992|NCT02037165|147735941|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.76|STANDARD_ERROR_OF_MEAN|1.0986|||TWO_SIDED|95.0|-1.4|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-1.4|
73877954|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.091|||<|0.001|TWO_SIDED|95.0|0.053|0.13|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.130|0.053|<0.001
74003418|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|0.22||||0.9072|TWO_SIDED|90.0|-2.897|3.339|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, emotional fx change from BL at W12||3.339|-2.897|0.9072
74003419|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.47||||0.0161|TWO_SIDED|90.0|1.42|7.522|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, emotional fx change from BL at W12||7.522|1.420|0.0161
74037779|NCT01797965|147628906|SUPERIORITY|||||||0.3619|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301||||0.3619
74037780|NCT01797965|147628906|SUPERIORITY|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301||||0.0170
74037781|NCT01797965|147628906|SUPERIORITY|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303||||0.0170
74037782|NCT01797965|147628906|SUPERIORITY|||||||0.0849|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303||||0.0849
74037783|NCT01797965|147628906|SUPERIORITY|||||||0.0057|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303||||0.0057
74037784|NCT01797965|147628906|SUPERIORITY|||||||0.396|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303||||0.3960
74037785|NCT01797965|147628908|SUPERIORITY||Odds Ratio (OR)|0.902||||0.8417|TWO_SIDED|95.0|0.329|2.473|||Regression, Logistic|Adjusted for the baseline relapse rate, history of prior IFN beta use (yes/no), baseline EDSS (\<=2.5 vs \>2.5) and baseline age (\<=35 vs \>35).||||2.473|0.329|0.8417
74037786|NCT01797965|147628930|SUPERIORITY|||||||0.3813|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 12||||0.3813
74037787|NCT01797965|147628930|SUPERIORITY|||||||0.1679|||||||ANOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 24||||0.1679
74037788|NCT01797965|147628930|SUPERIORITY|||||||0.5634|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 48||||0.5634
74003420|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.06||||0.0271|TWO_SIDED|90.0|1.042|7.071|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, emotional fx change from BL at W12||7.071|1.042|0.0271
74037789|NCT01797965|147628930|SUPERIORITY|||||||0.7003|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 144||||0.7003
74037790|NCT01797965|147628930|SUPERIORITY|||||||0.7812|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 168||||0.7812
74037791|NCT01797965|147628930|SUPERIORITY|||||||0.3246|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 192||||0.3246
74037792|NCT01797965|147628930|SUPERIORITY|||||||0.6423|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 216||||0.6423
74037793|NCT01797965|147628930|SUPERIORITY|||||||0.0288|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 240||||0.0288
74037794|NCT01797965|147628931|SUPERIORITY|||||||0.2567|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301||||0.2567
74037795|NCT01797965|147628931|SUPERIORITY|||||||0.6152|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301||||0.6152
74037796|NCT01797965|147628931|SUPERIORITY|||||||0.2024|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301||||0.2024
74037797|NCT01797965|147628931|SUPERIORITY|||||||0.9988|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301||||0.9988
73877955|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.012|TWO_SIDED|95.0|0.011|0.088|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.088|0.011|0.012
73877956|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.077|||<|0.001|TWO_SIDED|95.0|0.039|0.116|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.116|0.039|<0.001
73877957|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.157|TWO_SIDED|95.0|-0.011|0.066|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.066|-0.011|0.157
74003421|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|5.9||||0.002|TWO_SIDED|90.0|2.778|9.026|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, emotional fx change from BL at W12||9.026|2.778|0.0020
74037798|NCT01797965|147628931|SUPERIORITY|||||||0.7962|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301||||0.7962
74037799|NCT01797965|147628931|SUPERIORITY|||||||0.8486|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301||||0.8486
74037800|NCT01797965|147628931|SUPERIORITY|||||||0.4478|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301||||0.4478
74037801|NCT01797965|147628931|SUPERIORITY|||||||0.325|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301||||0.3250
74037802|NCT01797965|147628931|SUPERIORITY|||||||0.129|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301||||0.1290
74037803|NCT01797965|147628931|SUPERIORITY|||||||0.7295|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301||||0.7295
74037804|NCT01797965|147628931|SUPERIORITY|||||||0.8647|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301||||0.8647
74037805|NCT01797965|147628931|SUPERIORITY|||||||0.2183|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301||||0.2183
74037806|NCT01797965|147628931|SUPERIORITY|||||||0.3945|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303||||0.3945
74037807|NCT01797965|147628931|SUPERIORITY|||||||0.5068|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303||||0.5068
73877958|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.069||||0.021|TWO_SIDED|95.0|0.011|0.128|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|0.011|0.021
73877959|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.053|0.17|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.053|<0.001
73877960|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.162|||<|0.001|TWO_SIDED|95.0|0.103|0.22|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.220|0.103|<0.001
74003422|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.26||||0.7711|TWO_SIDED|90.0|-1.756|1.229|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, systemic symptoms change from BL at W12||1.229|-1.756|0.7711
74037808|NCT01797965|147628931|SUPERIORITY|||||||0.1669|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303||||0.1669
74037809|NCT01797965|147628931|SUPERIORITY|||||||0.5038|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303||||0.5038
74037810|NCT01797965|147628931|SUPERIORITY|||||||0.6001|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 303||||0.6001
74037811|NCT01797965|147628931|SUPERIORITY|||||||0.8617|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 168 for 303||||0.8617
74037812|NCT01797965|147628931|SUPERIORITY|||||||0.259|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 192 for 303||||0.2590
74037813|NCT01797965|147628931|SUPERIORITY|||||||0.5159|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 216 for 303||||0.5159
74037814|NCT01797965|147628931|SUPERIORITY|||||||0.6123|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 240 for 303||||0.6123
74037815|NCT00973921|147628932|SUPERIORITY_OR_OTHER||Proportion|1.0|||<|0.01|TWO_SIDED|95.0|0.86|1.0|||Wilson|||The 95% confidence Interval (CI) of the primary outcome has been calculated using the Wilson method of estimating the CI of a single proportion||1.0|0.86|<0.01
73877961|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.157|||<|0.001|TWO_SIDED|95.0|0.099|0.215|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.215|0.099|<0.001
73877962|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.154|0.271|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.271|0.154|<0.001
73877963|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.149|TWO_SIDED|95.0|-0.015|0.101|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.101|-0.015|0.149
73877964|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.092||||0.002|TWO_SIDED|95.0|0.034|0.151|||Mixed Models Analysis|||"week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.151|0.034|0.002
73877965|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.088||||0.003|TWO_SIDED|95.0|0.031|0.146|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.146|0.031|0.003
74003423|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.69||||0.0582|TWO_SIDED|90.0|0.223|3.147|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, systemic symptoms change from BL at W12||3.147|0.223|0.0582
74003424|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.68||||0.0558|TWO_SIDED|90.0|0.235|3.12|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, systemic symptoms change from BL at W12||3.120|0.235|0.0558
74003425|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.66||||0.0686|TWO_SIDED|90.0|0.161|3.153|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, systemic symptoms change from BL at W12||3.153|0.161|0.0686
74003426|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.33||||0.7561|TWO_SIDED|90.0|-2.094|1.429|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, social fx change from BL at W12||1.429|-2.094|0.7561
74003427|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|2.17||||0.0384|TWO_SIDED|90.0|0.447|3.891|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, social fx change from BL at W12||3.891|0.447|0.0384
73877966|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.096|TWO_SIDED|95.0|-0.009|0.108|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.108|-0.009|0.096
74003428|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.86||||0.0729|TWO_SIDED|90.0|0.154|3.557|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, social fx change from BL at W12||3.557|0.154|0.0729
74003429|NCT01620255|147555653|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|2.95||||0.006|TWO_SIDED|90.0|1.19|4.715|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, social fx change from BL at W12||4.715|1.190|0.0060
74003430|NCT01620255|147555654|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.002||||0.5201|TWO_SIDED|90.0|-0.145|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo||0.142|-0.145|0.5201
73877967|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.122|TWO_SIDED|95.0|-0.012|0.103|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.103|-0.012|0.122
73877968|NCT03084796|147295444|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.886|TWO_SIDED|95.0|-0.062|0.054|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.054|-0.062|0.886
74003431|NCT01620255|147555654|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.183||||0.0217|TWO_SIDED|90.0|0.039|0.328||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo||0.328|0.039|0.0217
74003432|NCT01620255|147555654|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.096||||0.1473|TWO_SIDED|90.0|-0.045|0.237||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo||0.237|-0.045|0.1473
74008925|NCT01750931|147568225|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|105.02||||0.9712|TWO_SIDED|95.0|99.69|110.63|||ANOVA||Comparison of AUC0-t between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg|||110.63|99.69|0.9712
74008926|NCT01750931|147568225|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.31||||0.9951|TWO_SIDED|95.0|99.05|105.69|||ANOVA||Comparison of AUC0-infinity between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg|||105.69|99.05|0.9951
73877969|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.029|TWO_SIDED|95.0|0.008|0.141|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.141|0.008|0.029
74003433|NCT01620255|147555654|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.112||||0.1231|TWO_SIDED|90.0|-0.038|0.261||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo||0.261|-0.038|0.1231
74003434|NCT04256603|147555667|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||wilcox two sample test||||0.67
74003435|NCT00388453|147555673|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||.05
74003436|NCT03818204|147555688|OTHER||||||>=|0.46|||||||Regression, Linear|||The effect of angular position was modeled using linear mixed-effects (multiple regression) models. The five angles were randomly mapped for the dependent variable interpalpebral fissure. Because there were repeated measurements on each eye and each participant might respond differently to each angular position, participant and angular position within participant-eye were included as random effects.||||>=0.46
74003437|NCT00879762|147555701|NON_INFERIORITY|The non-inferiority margin is 2.5. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the hazard ratio is less than 2.5.|Hazard Ratio (HR)|0.587|||||TWO_SIDED|95.0|0.398|0.868|||||A survival analysis for interval censored data was performed to estimate the hazard ratio. The 95% CI for the hazard ratio was estimated using bootstrap.|Null hypothesis: Median time to seroconversion among participants receiving one standard dose in Group B is 2.5-fold higher compared to participants receiving one high dose in Group A (hazard ratio = 2.5).||0.868|0.398|
74037816|NCT00973921|147628933|SUPERIORITY_OR_OTHER||Correlation coefficient|0.74|||<|0.0001|||||||Bland Altman|||||||<0.0001
74037817|NCT00973921|147628935|SUPERIORITY_OR_OTHER||Correlation coefficient|0.5||||0.0034|||||||Bland-Altman|||||||0.0034
74037818|NCT00239837|147628971|SUPERIORITY_OR_OTHER_LEGACY||Wald χ2|7.14||||0.008|TWO_SIDED||||||Regression, Logistic|Data analyzed using repeated logistic regression model (generalized estimating equations). Domain X EV Level X Group interaction tested.|We began the analyses with a full-factorial model regressing choice on domain (gain=1, loss=0), the EV of the risky choice relative to the safe option (EV; range = -.38 to +.38), and dummy-coded treatment groups (Control= -1, Intervention =1).|||||.008
74037819|NCT01906866|147629013|SUPERIORITY||Mean Difference (Final Values)|32.32|STANDARD_ERROR_OF_MEAN|15.1|=|0.035|TWO_SIDED|95.0|2.38|62.26|||Mixed Models Analysis|||||62.26|2.38|=0.035
74037820|NCT01906866|147629014|SUPERIORITY||Mean Difference (Final Values)|-25.2|STANDARD_ERROR_OF_MEAN|9.787|=|0.011|TWO_SIDED|95.0|-44.61|-5.8|||Mixed Models Analysis|||||-5.8|-44.61|=0.011
74037821|NCT01906866|147629017|SUPERIORITY|||||||0.053|||||||MMRM|||Mixed Models for Repeated Measures (MMRM) analysis||||0.053
73877970|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.121|||<|0.001|TWO_SIDED|95.0|0.055|0.188|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.188|0.055|<0.001
74003438|NCT00879762|147555702|NON_INFERIORITY|The non-inferiority margin is 2.5. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the hazard ratio is less than 2.5.|Hazard Ratio (HR)|0.583|||||TWO_SIDED|95.0|0.384|0.853|||||A survival analysis for interval censored data was performed to estimate the hazard ratio. The 95% CI for the hazard ratio was estimated using bootstrap.|Null hypothesis: Median time to seroconversion among participants receiving one standard dose in Group B is 2.5-fold higher compared to participants receiving one high dose in Group A (hazard ratio = 2.5).||0.853|0.384|
74003439|NCT00879762|147555708|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2.5 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-0.2|0.97|||||Estimate and corresponding 95% confidence interval are calculated on the log2.5 scale.|Null hypothesis: The mean difference in log2.5 transformed peak titers between Group A and Group B \>= 1.||0.97|-0.20|
74003440|NCT00879762|147555709|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2.5 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|-0.17|1.0|||||Estimate and corresponding 95% confidence interval are calculated on the log2.5 scale.|Null hypothesis: The mean difference in log2.5 transformed peak titers between Group A and Group B \>= 1.||1.00|-0.17|
74003441|NCT04981366|147555710|SUPERIORITY|||||||0.013|TWO_SIDED|95.0||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||0.013
74003442|NCT04981366|147555711|SUPERIORITY||||||<|0.001||||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||<0.001
74037822|NCT01906866|147629017|SUPERIORITY|||||||0.039|||||||MI analysis|||||||0.039
74037823|NCT01906866|147629019|SUPERIORITY|||||||0.077|||||||MMRM|||||||0.077
74037824|NCT01906866|147629020|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
74037825|NCT00723073|147629032|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|STANDARD_DEVIATION|1.0||0.96|TWO_SIDED|95.0|0.89|1.1|||Fisher Exact|||||1.10|0.89|0.96
74037826|NCT00723073|147629033|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|STANDARD_DEVIATION|1.0|>|0.99|TWO_SIDED|95.0|0.38|2.7|||Fisher Exact|||||2.70|0.38|>0.99
74037827|NCT00723073|147629034|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|STANDARD_DEVIATION|1.0|>|0.99|TWO_SIDED|95.0|0.44|1.97|||Fisher Exact|||||1.97|0.44|>0.99
74037828|NCT00723073|147629035|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12|STANDARD_DEVIATION|1.0||0.48|TWO_SIDED|95.0|0.61|2.07|||Fisher Exact|||||2.07|0.61|0.48
74037829|NCT00723073|147629036|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57|STANDARD_DEVIATION|1.0||0.57|TWO_SIDED|95.0|0.1|3.37|||Fisher Exact|||||3.37|0.10|0.57
74003443|NCT04981366|147555712|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003444|NCT04981366|147555713|SUPERIORITY|||||||0.007||||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||0.007
74003445|NCT04981366|147555714|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003446|NCT04981366|147555715|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003447|NCT04981366|147555716|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
74003448|NCT04981366|147555717|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003449|NCT04981366|147555718|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003450|NCT04981366|147555719|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003451|NCT04981366|147555720|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74037830|NCT00723073|147629037|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Chi-squared|||||||0.66
74003452|NCT04981366|147555721|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74003453|NCT04981366|147555722|SUPERIORITY|||||||0.033|||||||Mixed Models Analysis|||||||0.033
74003454|NCT04981366|147555723|SUPERIORITY|||||||0.944|||||||Mixed Models Analysis|||||||0.944
74003455|NCT04981366|147555724|SUPERIORITY|||||||0.203|||||||Mixed Models Analysis|||||||0.203
74003456|NCT04981366|147555725|SUPERIORITY|||||||0.027|||||||Mixed Models Analysis|||||||0.027
74003457|NCT04981366|147555726|SUPERIORITY|||||||0.145|||||||Mixed Models Analysis|||||||0.145
74003458|NCT04981366|147555727|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74003459|NCT04981366|147555728|SUPERIORITY|||||||0.551|||||||Mixed Models Analysis|||||||0.551
74003460|NCT04981366|147555729|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74003461|NCT04981366|147555730|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74003462|NCT04981366|147555731|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74003463|NCT04981366|147555732|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
74003464|NCT04981366|147555733|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003465|NCT04981366|147555734|SUPERIORITY|||||||0.344|||||||Mixed Models Analysis|||||||0.344
74003466|NCT04981366|147555735|SUPERIORITY|||||||0.613|||||||Mixed Models Analysis|||||||0.613
74003467|NCT04981366|147555736|SUPERIORITY|||||||0.944|||||||Mixed Models Analysis|||||||0.944
74003468|NCT04981366|147555737|SUPERIORITY|||||||0.601|||||||Mixed Models Analysis|||||||0.601
74003469|NCT04981366|147555738|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003470|NCT04981366|147555739|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003471|NCT04981366|147555740|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003472|NCT04981366|147555742|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003473|NCT04981366|147555743|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003474|NCT04981366|147555744|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003475|NCT04981366|147555745|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003476|NCT04981366|147555746|SUPERIORITY|||||||0.017|||||||Mixed Models Analysis|||||||0.017
74003477|NCT04981366|147555747|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003478|NCT04981366|147555748|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|||||||0.949
74003479|NCT04981366|147555749|SUPERIORITY|||||||0.993|||||||Mixed Models Analysis|||||||0.993
74003480|NCT04981366|147555750|SUPERIORITY|||||||0.601|||||||Mixed Models Analysis|||||||0.601
74003481|NCT04981366|147555751|SUPERIORITY|||||||0.408|||||||Mixed Models Analysis|||||||0.408
74003482|NCT04981366|147555752|SUPERIORITY|||||||0.082|||||||Mixed Models Analysis|||||||0.082
74003483|NCT04981366|147555753|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.550
74003484|NCT04981366|147555754|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.700
74003485|NCT04981366|147555755|SUPERIORITY|||||||0.254|||||||Mixed Models Analysis|||||||0.254
74003486|NCT04981366|147555756|SUPERIORITY|||||||0.373|||||||Mixed Models Analysis|||||||0.373
74003487|NCT04981366|147555757|SUPERIORITY|||||||0.407|||||||Mixed Models Analysis|||||||0.407
74003488|NCT04981366|147555758|SUPERIORITY|||||||0.051|||||||Mixed Models Analysis|||||||0.051
74003489|NCT04981366|147555759|SUPERIORITY|||||||0.385|||||||Mixed Models Analysis|||||||0.385
74003490|NCT04981366|147555760|SUPERIORITY|||||||0.239|||||||Mixed Models Analysis|||||||0.239
74003491|NCT04981366|147555761|SUPERIORITY|||||||0.463|||||||Mixed Models Analysis|||||||0.463
74003492|NCT04981366|147555762|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
74003493|NCT04981366|147555763|SUPERIORITY|||||||0.469|||||||Mixed Models Analysis|||||||0.469
74003494|NCT04981366|147555764|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
74003495|NCT04981366|147555765|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||0.064
74003496|NCT04981366|147555766|SUPERIORITY|||||||0.0314|||||||Mixed Models Analysis|||||||0.0314
74003497|NCT04981366|147555767|SUPERIORITY|||||||0.0147|||||||Mixed Models Analysis|||||||0.0147
74003498|NCT04981366|147555768|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
74003499|NCT04981366|147555769|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74003500|NCT04981366|147555770|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74008927|NCT02871778|147568234|SUPERIORITY||Least Square (LS) Mean difference|1.519||||0.0437|TWO_SIDED|95.0|0.044|2.995|||Mixed-effects Model|||||2.995|0.044|0.0437
74008928|NCT02871778|147568234|SUPERIORITY||LS Mean difference|0.04||||0.9755|TWO_SIDED|95.0|-2.509|2.589|||Mixed-effects Model|||||2.589|-2.509|0.9755
74008929|NCT02871778|147568234|SUPERIORITY||LS Mean difference|2.318||||0.0731|TWO_SIDED|95.0|-0.22|4.856|||Mixed-effects Model|||||4.856|-0.22|0.0731
74008930|NCT02871778|147568234|SUPERIORITY||LS Mean Difference|0.799||||0.5373|TWO_SIDED|95.0|-1.751|3.348|||Mixed-effects Model|||||3.348|-1.751|0.5373
74008931|NCT02871778|147568234|SUPERIORITY||LS Mean difference|0.838||||0.453|TWO_SIDED|95.0|-1.368|3.045|||Mixed-effects Model|||||3.045|-1.368|0.453
74008932|NCT02653300|147568245|OTHER|||||||0.03125|||||||Sign test|||||||0.03125
73877971|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.184|||<|0.001|TWO_SIDED|95.0|0.117|0.25|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.250|0.117|<0.001
73877972|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.208|||<|0.001|TWO_SIDED|95.0|0.142|0.275|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.275|0.142|<0.001
73877973|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.293|||<|0.001|TWO_SIDED|95.0|0.227|0.36|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.360|0.227|<0.001
74003501|NCT00676065|147555781|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||0.9|0.2|
74003502|NCT00676065|147555781|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||0.9|0.2|
74003503|NCT00676065|147555782|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.8|1.7|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||1.7|0.8|
74037831|NCT00723073|147629040|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Fisher Exact|||||||0.22
74037832|NCT00723073|147629041|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Fisher Exact|||||||0.11
74037833|NCT00302718|147629050|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
74037834|NCT00302718|147629052|OTHER|||||||0.2114|||||||Chi-squared|||||||0.2114
74037835|NCT00302718|147629054|OTHER|||||||0.6954|||||||Chi-squared|||||||0.6954
74037836|NCT00302718|147629056|OTHER|||||||0.9895|||||||Chi-squared|||||||0.9895
73877974|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.161|TWO_SIDED|95.0|-0.019|0.113|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.113|-0.019|0.161
73877975|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.109||||0.001|TWO_SIDED|95.0|0.043|0.176|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.176|0.043|0.001
73877976|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.134|||<|0.001|TWO_SIDED|95.0|0.068|0.201|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.201|0.068|<0.001
74003504|NCT00676065|147555782|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.0|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||1.0|0.5|
74037837|NCT00383721|147629132|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74037838|NCT00383721|147629132|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74037839|NCT00383721|147629133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||ANCOVA|||||||0.062
74037840|NCT00383721|147629133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.583|||||||ANCOVA|||||||0.583
74037841|NCT00383721|147629134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||ANCOVA|||||||0.020
74037842|NCT00383721|147629134|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
74037843|NCT03519516|147629145|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.749|||||||Wilcoxon (Mann-Whitney)|||||||0.749
74037844|NCT03519516|147629146|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.041|||||||Chi-squared|||||||0.041
74037845|NCT03519516|147629147|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.694|||||||Wilcoxon (Mann-Whitney)|||||||0.694
74037846|NCT03519516|147629148|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.495|||||||Wilcoxon (Mann-Whitney)|||||||0.495
74037847|NCT03519516|147629149|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.492||||||statistical analysis between groups for final visit with green lissamine|Chi-squared|||||||0.492
74037848|NCT03519516|147629149|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.238||||||statistical analysis between groups for final visit with fluorescein|Chi-squared, Corrected|||||||0.238
74003505|NCT00676065|147555783|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.4|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||1.4|0.5|
74003506|NCT00676065|147555783|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.5|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||1.5|0.6|
74003507|NCT00690820|147555874|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74003508|NCT00690820|147555875|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74003509|NCT00690820|147555876|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74003510|NCT00690820|147555877|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74003511|NCT00690820|147555878|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74003512|NCT00690820|147555879|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.671
74037849|NCT03519516|147629150|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.213|||||||Chi-squared|||||||0.213
73877977|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.066|TWO_SIDED|95.0|-0.004|0.128|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|-0.004|0.066
74003513|NCT00690820|147555880|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.003
74003514|NCT00690820|147555881|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.023
74003515|NCT03339570|147555886|SUPERIORITY||Mean Difference (Final Values)|18.3|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||Student's t test was used if they were variables adjusted to a normal distribution, or the Mann-Whitney U test if they were non-normal variables.||||<0.01
74003516|NCT01337115|147555927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.44|STANDARD_ERROR_OF_MEAN|8.4||0.001|TWO_SIDED|95.0|11.55|45.34|||t-test, 2 sided|||Difference between mean VAS pain scores. Power 80%. Null hypothesis states there is no difference between pains scores in both groups||45.34|11.55|0.001
74003517|NCT01337115|147555928|SUPERIORITY_OR_OTHER|||||||0.537||||||The null hypothesis is that there is no difference in patient satisfaction distribution by the three categories used (Bad; Reasonable; Good/Very Good) between groups.|Fisher's exact test|Fisher's Exact test allows to test for the significance of the distribution in the results table with three categories.||||||0.537
74003518|NCT01337115|147555929|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.92|STANDARD_ERROR_OF_MEAN|5.67||0.006|TWO_SIDED|95.0|5.52|28.33|||t-test, 2 sided|||Null hypothesis states that there is no difference between groups. Power 80%||28.33|5.52|0.006
74003519|NCT01337115|147555930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|7.14||0.723|TWO_SIDED|95.0|-16.93|11.83|||t-test, 2 sided|||Null hypothesis states there is no difference between both groups. Power 80% to detect 15% difference in means||11.83|-16.93|0.723
74003520|NCT00679627|147555940|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
74003521|NCT00679627|147555941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.011|TWO_SIDED|95.0|0.37|0.89|||Regression, Cox|||||0.89|0.37|0.011
74003522|NCT00679627|147555942|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
74003523|NCT00679627|147555943|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||||||0.002
74003524|NCT00679627|147555946|SUPERIORITY_OR_OTHER|||||||0.269||||||Baseline|Cochran-Mantel-Haenszel|||||||0.269
74003525|NCT00679627|147555946|SUPERIORITY_OR_OTHER|||||||0.835||||||Month 24|Cochran-Mantel-Haenszel|||||||0.835
74003526|NCT00679627|147555947|SUPERIORITY_OR_OTHER|||||||0.194||||||Orientation subscale|ANCOVA|||||||0.194
74003527|NCT00679627|147555947|SUPERIORITY_OR_OTHER|||||||0.353||||||Registration subscale|ANCOVA|||||||0.353
74003528|NCT00679627|147555947|SUPERIORITY_OR_OTHER|||||||0.009||||||Attention and Calculation subscale|ANCOVA|||||||0.009
74003529|NCT00679627|147555947|SUPERIORITY_OR_OTHER|||||||0.158||||||Recall subscale|ANCOVA|||||||0.158
74003530|NCT00679627|147555947|SUPERIORITY_OR_OTHER|||||||0.088||||||Language subscale|ANCOVA|||||||0.088
74003531|NCT00679627|147555948|SUPERIORITY_OR_OTHER|||||||0.01||||||Initiation subscale|ANCOVA|||||||0.010
74003532|NCT00679627|147555948|SUPERIORITY_OR_OTHER|||||||0.043||||||Planning and Organization subscale|ANCOVA|||||||0.043
74003533|NCT00679627|147555948|SUPERIORITY_OR_OTHER|||||||0.018||||||Effective Performance subscale|ANCOVA|||||||0.018
74037850|NCT03519516|147629152|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.741|||||||Chi-squared, Corrected|||||||0.741
73877978|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.01|TWO_SIDED|95.0|0.021|0.153|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.153|0.021|0.010
73877979|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.465|TWO_SIDED|95.0|-0.042|0.091|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|-0.042|0.465
73877980|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.008|TWO_SIDED|95.0|0.03|0.195|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.030|0.008
74003534|NCT00679627|147555948|SUPERIORITY_OR_OTHER|||||||0.005||||||Basic subscale|ANCOVA|||||||0.005
74003535|NCT00679627|147555948|SUPERIORITY_OR_OTHER|||||||0.054||||||Instrumental subscale|ANCOVA|||||||0.054
74003536|NCT00679627|147555948|SUPERIORITY_OR_OTHER|||||||0.137||||||Leisure subscale|ANCOVA|||||||0.137
74037851|NCT03519516|147629154|NON_INFERIORITY|The study drug is considered non-inferior with respect to the comparator if there are no differences above twenty percent||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.110
74037852|NCT00592553|147629159|OTHER||Least Square (LS) Mean Difference|-30.52|STANDARD_ERROR_OF_MEAN|42.68||0.4756|TWO_SIDED|95.0|-114.8|53.75|||Mixed Models Analysis|||Analysis was performed using mixed model for repeated measures (MMRM) method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (less than \[\<\] 9 years versus \[vs.\] greater than or equal to \[\>=\] 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.||53.75|-114.8|0.4756
74037853|NCT00592553|147629159|OTHER||LS Mean Difference|62.65|STANDARD_ERROR_OF_MEAN|43.21||0.149|TWO_SIDED|95.0|-22.66|147.96|||Mixed Models Analysis|||Analysis was performed using MMRM method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (\< 9 years vs. \>= 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.||147.96|-22.66|0.1490
74037854|NCT01146951|147629182|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-26.65||||0.003|TWO_SIDED|90.0|-40.3|-11.8|||Wilcoxon (Mann-Whitney)|||||-11.80|-40.30|0.003
74037855|NCT01146951|147629183|SUPERIORITY_OR_OTHER|||||||0.074|||||||Fisher's exact test|||||||0.074
73877981|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.173|||<|0.001|TWO_SIDED|95.0|0.091|0.256|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.256|0.091|<0.001
73877982|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.219|||<|0.001|TWO_SIDED|95.0|0.136|0.302|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.302|0.136|<0.001
73877983|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.131|0.295|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.295|0.131|<0.001
73877984|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.326|||<|0.001|TWO_SIDED|95.0|0.244|0.409|||McNemar|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.409|0.244|<0.001
74003537|NCT01886378|147556006|SUPERIORITY||Least squares (LS) mean|423.594||||0.1518|TWO_SIDED|95.0|-155.66|1002.85||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% confidence interval (CI), and p-values are based on the GEE model.|||1002.85|-155.66|0.1518
74003538|NCT01886378|147556007|SUPERIORITY||LS mean|-0.011||||0.3964|TWO_SIDED|95.0|-0.04|0.01||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||0.01|-0.04|0.3964
74003539|NCT01886378|147556008|SUPERIORITY||LS mean|4.671||||0.0777|TWO_SIDED|95.0|-0.52|9.86||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||9.86|-0.52|0.0777
74003540|NCT01886378|147556009|SUPERIORITY||LS mean|181.37||||0.083|TWO_SIDED|95.0|-23.7|386.45||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||386.45|-23.70|0.0830
74003541|NCT01886378|147556010|SUPERIORITY||LS mean|-0.185||||0.032|TWO_SIDED|95.0|-0.35|-0.02||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||-0.02|-0.35|0.0320
74037856|NCT01146951|147629184|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-33.3|||<|0.001|TWO_SIDED|90.0|-47.1|-17.0|||Wilcoxon (Mann-Whitney)|||||-17.00|-47.10|<0.001
74037857|NCT01146951|147629185|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-57.15||||0.025|TWO_SIDED|90.0|-104.5|-17.3|||Wilcoxon (Mann-Whitney)|||Analysis for Partial Seizure Frequency||-17.30|-104.50|0.025
74037858|NCT01146951|147629185|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-28.65||||0.128|TWO_SIDED|90.0|-72.0|0.9|||Wilcoxon (Mann-Whitney)|||Analysis of atypical absence seizure frequency||0.90|-72.00|0.128
74037859|NCT01146951|147629185|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-54.35||||0.021|TWO_SIDED|90.0|-126.6|-15.4|||Wilcoxon (Mann-Whitney)|||Analysis for myoclonic seizure frequency||-15.40|-126.60|0.021
74003542|NCT01886378|147556011|SUPERIORITY||LS mean|12.44||||0.085|TWO_SIDED|95.0|-1.72|26.6||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||26.60|-1.72|0.0850
74003543|NCT01886378|147556012|SUPERIORITY||LS mean|2.16||||0.3754|TWO_SIDED|95.0|-2.62|6.94||The LS Mean, standard error (SE), 95% CI, and 2-sided p-value are from the GEE model.|GEE model|||||6.94|-2.62|0.3754
74003544|NCT01886378|147556013|SUPERIORITY||LS mean|0.816||||0.7564|TWO_SIDED|95.0|-4.34|5.97||The LS Mean, SE, 95% CI, and 2-sided p-value are from the GEE model.|GEE model|||||5.97|-4.34|0.7564
74003545|NCT01886378|147556014|SUPERIORITY||LS mean|8.88|||<|0.0001|TWO_SIDED|95.0|5.67|12.08||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model|||||12.08|5.67|<0.0001
74003546|NCT01886378|147556015|SUPERIORITY||LS mean|9.7||||0.0152|TWO_SIDED|95.0|1.87|17.54||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||17.54|1.87|0.0152
74003547|NCT00446992|147556027|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||<0.001
74003548|NCT00446992|147556028|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||.043
74037860|NCT01146951|147629185|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-23.2||||0.031|TWO_SIDED|90.0|-40.7|-5.6|||Wilcoxon (Mann-Whitney)|||Analysis of tonic seizure frequency||-5.60|-40.70|0.031
74037861|NCT01146951|147629185|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-71.4||||0.107|TWO_SIDED|90.0|-464.7|30.5|||Wilcoxon (Mann-Whitney)|||Analysis for Tonic-clonic seizure frequency||30.50|-464.70|0.107
74037862|NCT01146951|147629185|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-52.1||||0.221|TWO_SIDED|90.0|-89.1|10.8|||Wilcoxon (Mann-Whitney)|||Analysis of Atonic seizure frequency||10.80|-89.10|0.221
74037863|NCT01146951|147629186|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Analysis of Week 12 of the Treatment Period||||0.041
74003549|NCT00446992|147556029|SUPERIORITY_OR_OTHER||||||=|0.69|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.690
74003550|NCT00446992|147556030|SUPERIORITY_OR_OTHER||||||=|0.691|TWO_SIDED||||||Intervariate|||Baseline compared to Week 16||||= 0.691
74003551|NCT00446992|147556031|SUPERIORITY_OR_OTHER||||||=|0.877|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.877
74003552|NCT00446992|147556032|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.003
74003553|NCT00446992|147556033|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= .005
74003554|NCT00446992|147556034|SUPERIORITY_OR_OTHER||||||=|0.696|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.696
74003555|NCT00446992|147556035|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.013
74003556|NCT03021954|147556042|SUPERIORITY|||||||0.086|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is in the intervention group, we expect a decrease in the area of the levator hiatus at 40 days and 3 months post-partum. Power 90 % confidence interval β = 0.10, α = 0.05||||0.086
74003557|NCT03021954|147556043|EQUIVALENCE|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is platelet rich plasma can maintain or increase levator ani muscle contractions post-partum||||0.29
74003558|NCT01668667|147556070|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-2.57|STANDARD_ERROR_OF_MEAN|0.745||0.014|TWO_SIDED|95.0|-4.62|-0.52|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||-0.52|-4.62|0.014
74003559|NCT01668667|147556070|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-2.61|STANDARD_ERROR_OF_MEAN|0.764||0.014|TWO_SIDED|95.0|-4.68|-0.54|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||-0.54|-4.68|0.014
74003560|NCT01668667|147556070|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-1.55|STANDARD_ERROR_OF_MEAN|0.767||0.144|TWO_SIDED|95.0|-3.63|0.53|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||0.53|-3.63|0.144
74037864|NCT01146951|147629186|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Analysis of final assessment (LOCF)||||0.007
74037865|NCT01299610|147629193|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.38|STANDARD_ERROR_OF_MEAN|0.538||0.48|TWO_SIDED|95.0|-1.46|0.7|||Mixed model for repeated measures|||||0.70|-1.46|0.480
74037866|NCT01299610|147629193|SUPERIORITY_OR_OTHER||mixed model for repeated measures|-0.89|STANDARD_ERROR_OF_MEAN|0.557||0.118|TWO_SIDED|95.0|-2.0|0.23|||Mixed model for repeated measures|||||0.23|-2.00|0.118
74037867|NCT01299610|147629193|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.51|STANDARD_ERROR_OF_MEAN|0.572||0.011|TWO_SIDED|95.0|-2.65|-0.36|||Mixed model for repeated measures|||||-0.36|-2.65|0.011
74037868|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.581|TWO_SIDED|95.0|-0.24|0.42|||Mixed model repeated measures|||GW870086, 0.2% cream Vs Placebo: Day 2||0.42|-0.24|0.581
74037869|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.169||0.655|TWO_SIDED|95.0|-0.42|0.27|||Mixed model repeated measures|||GW870086, 2.0% cream Vs Placebo: Day 2||0.27|-0.42|0.655
74090993|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.13|STANDARD_ERROR_OF_MEAN|3.2064|||TWO_SIDED|95.0|-12.5|0.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.2|-12.5|
74090994|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.88|STANDARD_ERROR_OF_MEAN|3.4032|||TWO_SIDED|95.0|-10.6|2.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-10.6|
74090995|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.67|STANDARD_ERROR_OF_MEAN|3.3393|||TWO_SIDED|95.0|-13.3|0.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.0|-13.3|
74090996|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.8|STANDARD_ERROR_OF_MEAN|3.5727|||TWO_SIDED|95.0|-8.9|5.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.3|-8.9|
74090997|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-4.43|STANDARD_ERROR_OF_MEAN|3.1554|||TWO_SIDED|95.0|-10.7|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-10.7|
74090998|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.18|STANDARD_ERROR_OF_MEAN|2.6161|||TWO_SIDED|95.0|-6.4|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-6.4|
74003561|NCT01668667|147556071|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.004|TWO_SIDED|95.0|1.3|3.95|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.95|1.30|0.004
74003562|NCT01668667|147556071|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.007|TWO_SIDED|95.0|1.23|3.77|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.77|1.23|0.007
74003563|NCT01668667|147556071|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.005|TWO_SIDED|95.0|1.27|3.94|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.94|1.27|0.005
74037870|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.174||0.336||95.0|-0.52|0.18|||Mixed model repeated measures|||FP, 0.05% cream Vs Placebo: Day 2||0.18|-0.52|0.336
74037871|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.03|STANDARD_ERROR_OF_MEAN|0.302||0.923|TWO_SIDED|95.0|-0.58|0.63|||Mixed model repeated measures|||GW870086 0.2% cream Vs Placebo: Day 3||0.63|-0.58|0.923
74037872|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.14|STANDARD_ERROR_OF_MEAN|0.314||0.657|TWO_SIDED|95.0|-0.49|0.77|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 3||0.77|-0.49|0.657
74037873|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.323||0.386|TWO_SIDED|95.0|-0.93|0.36|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 3||0.36|-0.93|0.386
74037874|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.24|STANDARD_ERROR_OF_MEAN|0.456||0.601|TWO_SIDED|95.0|-1.15|0.67|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 7||0.67|-1.15|0.601
74037875|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.472||0.212|TWO_SIDED|95.0|-1.54|0.35|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 7||0.35|-1.54|0.212
74037876|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.29|STANDARD_ERROR_OF_MEAN|0.485||0.01|TWO_SIDED|95.0|-2.26|-0.32|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 7||-0.32|-2.26|0.010
74003564|NCT01668667|147556072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||ANOVA|||For the mean change from Baseline for IRLS Rating Scale total score at the EOT, the linear contrast test based on an analysis of variance with treatment effect was used to detect linear dose-response trends across increasing levels of GEn dosage.||||0.022
74037877|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.24|STANDARD_ERROR_OF_MEAN|0.462||0.602|TWO_SIDED|95.0|-1.17|0.68|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 14||0.68|-1.17|0.602
74037878|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.65|STANDARD_ERROR_OF_MEAN|0.479||0.18|TWO_SIDED|95.0|-1.61|0.31|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 14||0.31|-1.61|0.180
74037879|NCT01299610|147629194|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.39|STANDARD_ERROR_OF_MEAN|0.492||0.006|TWO_SIDED|95.0|-2.37|-0.4|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 14||-0.40|-2.37|0.006
74037880|NCT01337167|147629204|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|9.68|||<|0.001|TWO_SIDED|95.0|4.83|14.83|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=1.0 μg/mL||14.83|4.83|<0.001
74037881|NCT01337167|147629204|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|4.87|||<|0.001|TWO_SIDED|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=0.15 μg/mL||8.14|2.23|<0.001
73877985|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.144|TWO_SIDED|95.0|-0.021|0.143|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.143|-0.021|0.144
74037882|NCT01337167|147629204|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419-Ctrl)|4.87|||<|0.001|TWO_SIDED|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Secondary Analysis: Non-inferiority for titer \>=0.15 μg/mL||8.14|2.23|<0.001
74037883|NCT01337167|147629205|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|0.84|||<|0.001|TWO_SIDED|95.0|-0.35|2.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.74|-0.35|<0.001
73877986|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.107||||0.011|TWO_SIDED|95.0|0.024|0.189|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.189|0.024|0.011
74003565|NCT01668667|147556072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|TWO_SIDED||||||ANOVA|||Overall treatment effect||||0.072
74037884|NCT01337167|147629206|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-3.84||||0.002|TWO_SIDED|95.0|-8.02|0.66|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||0.66|-8.02|0.002
74037885|NCT01337167|147629207|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.39|||<|0.001|TWO_SIDED|95.0|-0.28|1.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.74|-0.28|<0.001
74037886|NCT01337167|147629208|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-0.33|||<|0.001|TWO_SIDED|95.0|-1.8|1.6|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.60|-1.80|<0.001
74003566|NCT01668667|147556073|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||A significant p-value will indicate a nonzero linear effect across increasing levels of GEn dosage.|Cochran-Armitage trend test|||||||0.012
74003567|NCT01992393|147556109|OTHER|||||||0.036|||||||GEE|||||||0.036
74003568|NCT01992393|147556110|OTHER|||||||0.042|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.042
74037887|NCT01337167|147629209|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-4.7||||0.001|TWO_SIDED|95.0|-8.14|-0.97|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||-0.97|-8.14|0.001
74037888|NCT01337167|147629210|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-2.67|||<|0.001|TWO_SIDED|95.0|-7.27|2.23|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.23|-7.27|<0.001
74003569|NCT01992393|147556110|OTHER|||||||0.204|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU||||0.204
74003570|NCT01992393|147556111|OTHER|||||||0.129|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.129
73877987|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.016|TWO_SIDED|95.0|0.019|0.182|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.182|0.019|0.016
74003571|NCT01992393|147556111|OTHER|||||||0.978|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.978
74003572|NCT01992393|147556112|OTHER|||||||0.128|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.128
74003573|NCT01992393|147556112|OTHER|||||||0.015|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.015
74003574|NCT01992393|147556113|OTHER|||||||0.759|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.759
74003575|NCT01992393|147556113|OTHER|||||||0.471|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.471
74037889|NCT01337167|147629211|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|4.05|||<|0.001|TWO_SIDED|95.0|0.23|8.28|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||8.28|0.23|<0.001
73877988|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.28|TWO_SIDED|95.0|-0.037|0.128|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|-0.037|0.280
74003576|NCT01992393|147556114|OTHER|||||||0.775|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.775
74003577|NCT01992393|147556114|OTHER|||||||0.433|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.433
74003578|NCT01992393|147556115|OTHER|||||||0.936|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.936
74003579|NCT01992393|147556115|OTHER|||||||0.6|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.600
74003580|NCT01992393|147556116|OTHER|||||||0.56|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.560
74003581|NCT01992393|147556116|OTHER|||||||0.305|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.305
73877989|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.342|TWO_SIDED|95.0|-0.042|0.121|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.121|-0.042|0.342
74003582|NCT01013597|147556121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||t-test, 2 sided|||||||0.98
74003583|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.78||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.78|1.10|
74003584|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.32||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.32|0.90|
74003585|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.19|2.13||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.13|1.19|
74003586|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.62|0.93|
74003587|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|12.1|||||TWO_SIDED|95.0|8.63|17.08||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||17.08|8.63|
74003588|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.82|3.48||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.48|1.82|
74003589|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.8|||||TWO_SIDED|95.0|1.98|3.87||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.87|1.98|
74003590|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.0|4.08||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||4.08|2.00|
74003591|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.64|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.21|0.64|
74037890|NCT01337167|147629212|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|1.76|||<|0.001|TWO_SIDED|95.0|0.85|3.59|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.59|0.85|<0.001
74037891|NCT01337167|147629212|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.54|<0.001
74037892|NCT01337167|147629213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.26|||<|0.001|TWO_SIDED|95.0|-0.22|1.42|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.42|-0.22|<0.001
74037893|NCT01337167|147629213|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.54|<0.001
74037894|NCT01337167|147629214|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.25|||<|0.001|TWO_SIDED|95.0|-0.24|1.41|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.41|-0.24|<0.001
74037895|NCT01337167|147629214|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.53|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.53|<0.001
74037896|NCT01337167|147629215|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the Geometric Mean Concentration (GMC) ratio is \>=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|TWO_SIDED|95.0|1.2|1.38|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.38|1.20|<0.001
74037897|NCT01337167|147629216|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.64||||0.786|TWO_SIDED|95.0|0.59|0.7|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.70|0.59|0.786
74037898|NCT01337167|147629217|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.83|||<|0.001|TWO_SIDED|95.0|0.73|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.95|0.73|<0.001
74037899|NCT01337167|147629218|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|TWO_SIDED|95.0|1.15|1.42|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.42|1.15|<0.001
74037900|NCT01337167|147629219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|1.88|||<|0.001|TWO_SIDED|95.0|0.39|4.18|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||4.18|0.39|<0.001
73877990|NCT03084796|147295445|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.886|TWO_SIDED|95.0|-0.088|0.076|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.076|-0.088|0.886
73877991|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.003|TWO_SIDED|95.0|0.032|0.163|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.163|0.032|0.003
74003592|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.39|2.51||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.51|1.39|
74003593|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.56|2.41||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.41|1.56|
74037901|NCT01337167|147629220|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|1.3|||<|0.001|TWO_SIDED|95.0|-1.67|4.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||4.78|-1.67|<0.001
74037902|NCT01337167|147629221|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-0.41|||<|0.001|TWO_SIDED|95.0|-3.46|3.1|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.10|-3.46|<0.001
73877992|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.156|||<|0.001|TWO_SIDED|95.0|0.091|0.221|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.221|0.091|<0.001
73877993|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.208|||<|0.001|TWO_SIDED|95.0|0.143|0.273|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.273|0.143|<0.001
74003594|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.72|1.28||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.28|0.72|
74037903|NCT01337167|147629222|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|6.18|||<|0.001|TWO_SIDED|95.0|3.26|9.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||9.78|3.26|<0.001
74037904|NCT01337167|147629223|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.4|||<|0.001|TWO_SIDED|95.0|1.28|1.52|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.52|1.28|<0.001
74037905|NCT01337167|147629224|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.91|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.10|0.91|<0.001
74037906|NCT01337167|147629225|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.78||||0.014|TWO_SIDED|95.0|0.68|0.89|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.89|0.68|0.014
74003595|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.2|||||TWO_SIDED|95.0|3.67|7.33||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||7.33|3.67|
74037907|NCT01337167|147629226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.58|||<|0.001|TWO_SIDED|95.0|1.41|1.78|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.78|1.41|<0.001
74037908|NCT01337167|147629227|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.62|||<|0.001|TWO_SIDED|95.0|1.32|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.98|1.32|<0.001
74037909|NCT01337167|147629228|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.02|||<|0.001|TWO_SIDED|95.0|0.83|1.24|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.24|0.83|<0.001
74090999|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.35|STANDARD_ERROR_OF_MEAN|3.1849|||TWO_SIDED|95.0|-8.7|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-8.7|
73877994|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.237|||<|0.001|TWO_SIDED|95.0|0.172|0.302|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.302|0.172|<0.001
73877995|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.276|||<|0.001|TWO_SIDED|95.0|0.211|0.341|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.341|0.211|<0.001
73877996|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.076|TWO_SIDED|95.0|-0.006|0.124|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.124|-0.006|0.076
73877997|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.111|||<|0.001|TWO_SIDED|95.0|0.046|0.176|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.176|0.046|<0.001
74003596|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.08|1.73||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.73|1.08|
74037910|NCT01337167|147629232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||||TWO_SIDED|95.0|-18.4|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \<38°C||-7.7|-18.4|
73877998|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.075|0.205|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.205|0.075|<0.001
74003597|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.19|0.81|
73877999|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.116|TWO_SIDED|95.0|-0.013|0.117|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.117|-0.013|0.116
74003598|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.07|1.77||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.77|1.07|
74003599|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4||||||95.0|1.01|1.8||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.80|1.01|
74003600|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|1.3|2.15||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.15|1.30|
74003601|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.24|2.12||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.12|1.24|
74003602|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.03|1.79||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.79|1.03|
74003603|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5||||||95.0|1.11|1.98||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.98|1.11|
74003604|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.16|2.12||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.12|1.16|
74003605|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.86|1.47||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.47|0.86|
74003606|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.16|1.69||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.69|1.16|
74003607|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.87|1.54||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.54|0.87|
74003608|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.94|1.84||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.84|0.94|
74003609|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.4|||||TWO_SIDED|95.0|2.03|2.87||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.87|2.03|
74003610|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.13||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||1.13|0.84|
74037911|NCT01337167|147629232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||||TWO_SIDED|95.0|0.5|9.5|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=38°C and \<38.5°C||9.5|0.5|
73878000|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.081||||0.014|TWO_SIDED|95.0|0.016|0.146|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.146|0.016|0.014
74037912|NCT01337167|147629232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|2.8|11.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=38.5°C and \<39.5°C||11.2|2.8|
74037913|NCT01337167|147629232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-0.6|2.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=39.5°C||2.2|-0.6|
74003611|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.92|2.76||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.76|1.92|
74003612|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.55|2.42||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.42|1.55|
74003613|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||TWO_SIDED|95.0|1.84|2.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.67|1.84|
74003614|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||TWO_SIDED|95.0|4.13|5.93||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.93|4.13|
74003615|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.41|3.49||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.49|2.41|
74037914|NCT01337167|147629232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|||||TWO_SIDED|95.0|-18.6|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \<38°C||-7.7|-18.6|
74037915|NCT01337167|147629232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||||TWO_SIDED|95.0|1.9|10.8|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=38°C and \<38.5°C||10.8|1.9|
74037916|NCT01337167|147629232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||||TWO_SIDED|95.0|2.4|10.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=38.5°C and \<39.5°C||10.7|2.4|
74003616|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.34|3.52||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.52|2.34|
74003617|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||TWO_SIDED|95.0|4.01|5.93||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.93|4.01|
74003618|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.91|2.79||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.79|1.91|
74003619|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|2.02|2.66||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.66|2.02|
74037917|NCT01337167|147629232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-0.3|2.4|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=39.5°C||2.4|-0.3|
74037918|NCT02126670|147629258|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Chi-squared|||||||0.799
74037919|NCT02757092|147629260|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037920|NCT02757092|147629261|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
74037921|NCT02757092|147629262|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73878001|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.384|TWO_SIDED|95.0|-0.036|0.094|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.094|-0.036|0.384
73878002|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.064|0.236|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.236|0.064|<0.001
73878003|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.204|||<|0.001|TWO_SIDED|95.0|0.118|0.29|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.290|0.118|<0.001
74003620|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.0|||||TWO_SIDED|95.0|2.44|3.6||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.60|2.44|
74003621|NCT00427895|147556126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||TWO_SIDED|95.0|3.31|5.31||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.31|3.31|
74003622|NCT00427895|147556127|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|39.2|||||TWO_SIDED|95.0|33.0|45.1||||||||45.1|33.0|
74003623|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.4|||||TWO_SIDED|95.0|2.32|5.09||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||5.09|2.32|
74003624|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.13|2.16||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.16|1.13|
74037922|NCT02757092|147629263|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73878004|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.248|||<|0.001|TWO_SIDED|95.0|0.162|0.335|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.335|0.162|<0.001
73878005|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.254|||<|0.001|TWO_SIDED|95.0|0.168|0.339|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.339|0.168|<0.001
73878006|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.354|||<|0.001|TWO_SIDED|95.0|0.268|0.439|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.439|0.268|<0.001
74003625|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.88|1.98||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.98|0.88|
74003626|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.2|||||TWO_SIDED|95.0|2.04|4.97||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.97|2.04|
74003627|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.5|4.0||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.00|1.50|
74003628|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.7|||||TWO_SIDED|95.0|2.76|7.99||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||7.99|2.76|
74037923|NCT02757092|147629264|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73878007|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.054||||0.214|TWO_SIDED|95.0|-0.031|0.14|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.140|-0.031|0.214
74037924|NCT02757092|147629265|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
74037925|NCT02757092|147629266|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
74037926|NCT02757092|147629267|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037927|NCT02757092|147629268|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037928|NCT02757092|147629269|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037929|NCT02757092|147629270|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037930|NCT02757092|147629271|SUPERIORITY|||||||0.05|||||||Chi-squared|||Descriptive statistics were expressed as mean ± standard deviation or median and interquartile range depending on the nature and distribution of the variables||||0.05
74003629|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|0.93|2.97||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.97|0.93|
74003630|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|0.99|2.39||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.39|0.99|
74003631|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||TWO_SIDED|95.0|1.37|3.5||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.50|1.37|
74003632|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||TWO_SIDED|95.0|1.78|3.68||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.68|1.78|
74003633|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||TWO_SIDED|95.0|1.77|4.01||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.01|1.77|
74003634|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.5|||||TWO_SIDED|95.0|1.99|6.13||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||6.13|1.99|
74003635|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||TWO_SIDED|95.0|2.87|6.08||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.08|2.87|
74003636|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||TWO_SIDED|95.0|2.26|4.3||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.30|2.26|
74037931|NCT02757092|147629272|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
74037932|NCT02757092|147629273|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74003637|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT ratio|2.6|||||TWO_SIDED|95.0|1.72|3.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.80|1.72|
74003638|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|6.5|||||TWO_SIDED|95.0|4.09|10.19||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||10.19|4.09|
74003639|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|1.83|4.63||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.63|1.83|
74003640|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.8|||||TWO_SIDED|95.0|2.41|6.03||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.03|2.41|
74003641|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.8|||||TWO_SIDED|95.0|3.13|10.82||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||10.82|3.13|
74003642|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.3|2.84||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.84|1.30|
74003643|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||TWO_SIDED|95.0|2.02|4.78||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.78|2.02|
74037933|NCT02757092|147629274|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037934|NCT02757092|147629275|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
74037935|NCT02757092|147629277|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037936|NCT02757092|147629278|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037937|NCT02757092|147629279|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037938|NCT02757092|147629280|SUPERIORITY||||||<|0.05|||||||Chi-squared|||null hypothesis||||<0.05
74037939|NCT02757092|147629281|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
74037940|NCT02757092|147629282|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
74037941|NCT02757092|147629283|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037942|NCT02757092|147629284|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
73878008|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.098||||0.025|TWO_SIDED|95.0|0.012|0.184|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.184|0.012|0.025
73878009|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.104||||0.016|TWO_SIDED|95.0|0.019|0.189|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.189|0.019|0.016
74003644|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||TWO_SIDED|95.0|1.87|3.76||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.76|1.87|
74003645|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.4|||||TWO_SIDED|95.0|2.97|6.58||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.58|2.97|
74037943|NCT02757092|147629286|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037944|NCT02757092|147629287|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037945|NCT02757092|147629288|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74037946|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.75|0.99|
74037947|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||0.89|0.59|
74037948|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||TWO_SIDED|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.44|1.96|
74037949|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.86|2.22|
74037950|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.75|1.10|
74037951|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.74|1.12|
74037952|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.24|1.59|
74037953|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.23|0.77|
74003646|NCT00427895|147556128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.5|||||TWO_SIDED|95.0|3.2|9.41||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||9.41|3.20|
74003647|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||TWO_SIDED|95.0|1.9|11.2||||||Serotype 1: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.2|1.9|
74037954|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.1|||||TWO_SIDED|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.86|1.61|
74037955|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.92|1.81|
74037956|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.0|||||TWO_SIDED|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.79|1.42|
73878010|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.313|TWO_SIDED|95.0|-0.042|0.13|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.130|-0.042|0.313
74003648|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.9|||||TWO_SIDED|95.0|-0.3|8.1||||||Serotype 3: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.1|-0.3|
74003649|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.4|||||TWO_SIDED|95.0|-0.2|7.2||||||Serotype 4: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|-0.2|
74003650|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.3|||||TWO_SIDED|95.0|-2.6|7.2||||||Serotype 5: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|-2.6|
74003651|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|26.6|||||TWO_SIDED|95.0|21.7|31.7||||||Serotype 6A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||31.7|21.7|
74003652|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.5|||||TWO_SIDED|95.0|3.2|12.0||||||Serotype 6B: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||12.0|3.2|
74003653|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|12.3|||||TWO_SIDED|95.0|7.3|17.4||||||Serotype 7F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||17.4|7.3|
74003654|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|14.1|||||TWO_SIDED|95.0|8.7|19.5||||||Serotype 9V: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||19.5|8.7|
74003655|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-5.6|3.8||||||Serotype 14: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.8|-5.6|
74003656|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||TWO_SIDED|95.0|2.6|10.5||||||Serotype 18C: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||10.5|2.6|
74003657|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.1|||||TWO_SIDED|95.0|1.2|7.1||||||Serotype 19A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.1|1.2|
74003658|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|-1.2|||||TWO_SIDED|95.0|-5.5|3.2||||||Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.||3.2|-5.5|
74003659|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|23.2|||||TWO_SIDED|95.0|17.0|29.3||||||Serotype 23F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||29.3|17.0|
74003660|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.6|||||TWO_SIDED|95.0|-0.2|7.5||||||Serotype 1: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.5|-0.2|
74003661|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.2|||||TWO_SIDED|95.0|-3.6|4.1||||||Serotype 3: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||4.1|-3.6|
74003662|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.4|||||TWO_SIDED|95.0|-0.4|5.5||||||Serotype 4: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.5|-0.4|
74003663|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-5.8|3.9||||||Serotype 5: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.9|-5.8|
74003664|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.2|||||TWO_SIDED|95.0|-0.4|4.8||||||Serotype 6A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||4.8|-0.4|
74003665|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.0|||||TWO_SIDED|95.0|0.8|7.2||||||Serotype 6B: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|0.8|
74003666|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.4|||||TWO_SIDED|95.0|0.6|8.2||||||Serotype 7F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.2|0.6|
74037957|NCT01646398|147629292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.49|1.84|
74037958|NCT01646398|147629293|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||||TWO_SIDED|95.0|19.3|34.0||||||Difference in proportions (13vPnC - 23vPS) expressed as a percentage presented along with exact, 2-sided 95%CI. Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.||34.0|19.3|
74037959|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.75|0.99|
74037960|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||0.89|0.59|
74003667|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.8|||||TWO_SIDED|95.0|-0.3|7.9||||||Serotype 9V: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.9|-0.3|
74003668|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Perecentage|4.2|||||TWO_SIDED|95.0|-0.1|8.7||||||Serotype 14: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.7|-0.1|
74003669|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.6|||||TWO_SIDED|95.0|-3.8|2.5||||||Serotype 18C: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||2.5|-3.8|
74037961|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|2.6|||||TWO_SIDED|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.44|1.96|
74037962|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|2.9|||||TWO_SIDED|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.86|2.22|
74037963|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.75|1.10|
73878011|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.25|TWO_SIDED|95.0|-0.035|0.135|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure.~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.135|-0.035|0.250
74003670|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.1|||||TWO_SIDED|95.0|-2.1|1.9||||||Serotype 19A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||1.9|-2.1|
74003671|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.9|||||TWO_SIDED|95.0|-2.4|6.2||||||Serotype 19F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.2|-2.4|
74003672|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.5|||||TWO_SIDED|95.0|-4.7|5.7||||||Serotype 23F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.7|-4.7|
74037964|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.74|1.12|
74037965|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|2.3|||||TWO_SIDED|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.24|1.59|
74037966|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.23|0.77|
74037967|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|2.1|||||TWO_SIDED|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.86|1.61|
74037968|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|2.3|||||TWO_SIDED|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.92|1.81|
74037969|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|2.0|||||TWO_SIDED|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.79|1.42|
74037970|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|2.5|||||TWO_SIDED|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.49|1.84|
74037971|NCT01646398|147629294|SUPERIORITY_OR_OTHER||GMT Ratio|3.1|||||TWO_SIDED|95.0|2.38|4.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 2.0.||4.14|2.38|
74037972|NCT01061736|147629349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.1155|TWO_SIDED|95.0|0.85|4.64||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. The multiplicity issues were addressed by using the Hommel-procedure.||4.64|0.85|0.1155
74037973|NCT01061736|147629349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84||||0.0041|TWO_SIDED|95.0|1.53|9.63||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||9.63|1.53|0.0041
74037974|NCT01061736|147629349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.7119|TWO_SIDED|95.0|0.52|2.61||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||2.61|0.52|0.7119
74037975|NCT01061736|147629349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0363|TWO_SIDED|95.0|1.06|5.35||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||5.35|1.06|0.0363
74037976|NCT01061736|147629349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.0426|TWO_SIDED|95.0|1.03|5.29||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||5.29|1.03|0.0426
74037977|NCT01061736|147629350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.773|||<|0.0001|TWO_SIDED|95.0|2.077|3.703||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo was derived. The multiplicity issues for part B were addressed by using a Bonferroni correction for each dose together with a hierarchical testing procedure across the 3 co-primary and the main secondary endpoints. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||3.703|2.077|<0.0001
73878012|NCT03084796|147295446|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.898|TWO_SIDED|95.0|-0.08|0.091|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|-0.080|0.898
74037978|NCT01061736|147629350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.975|||<|0.0001|TWO_SIDED|95.0|2.957|5.344||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||||5.344|2.957|<0.0001
74037979|NCT01061736|147629351|SUPERIORITY_OR_OTHER||LS mean difference|-0.235|||<|0.0001|TWO_SIDED|95.0|-0.312|-0.157||Threshold for significance = 0.025.|Mixed Models Analysis|||Analysis was performed using a mixed model for repeated measures (MMRM). Differences in least square (LS) mean between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoint was statistically significant).||-0.157|-0.312|<0.0001
74037980|NCT01061736|147629351|SUPERIORITY_OR_OTHER||LS mean difference|-0.258|||<|0.0001|TWO_SIDED|95.0|-0.336|-0.181||Threshold for significance = 0.025.|Mixed Models Analysis|||||-0.181|-0.336|<0.0001
74037981|NCT01061736|147629352|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA|||Analysis was performed using two-sided rank-based ANCOVA model. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).||||<0.0001
74037982|NCT01061736|147629352|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA|||||||<0.0001
74037983|NCT01061736|147629353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.661|||<|0.0001|TWO_SIDED|95.0|2.451|8.863||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).||8.863|2.451|<0.0001
74037984|NCT01061736|147629353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.565|||<|0.0001|TWO_SIDED|95.0|2.946|10.515||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||||10.515|2.946|<0.0001
74037985|NCT01114373|147629361|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.||||0.0269
74037986|NCT01114373|147629361|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||ANOVA|||||||0.84
74037987|NCT01114373|147629362|SUPERIORITY_OR_OTHER|||||||0.0492|TWO_SIDED||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.||||0.0492
74037988|NCT01114373|147629362|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANOVA|||||||0.95
74037989|NCT01114373|147629363|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
74037990|NCT01114373|147629364|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||ANOVA|||||||0.88
74037991|NCT01114373|147629365|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||ANOVA|||||||0.16
74037992|NCT01114373|147629366|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
74037993|NCT01114373|147629367|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
74037994|NCT01114373|147629368|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||||||0.21
74037995|NCT01114373|147629369|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Friedman|||||||0.06
73878013|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.035|TWO_SIDED|95.0|0.006|0.153|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.153|0.006|0.035
73878014|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.158|||<|0.001|TWO_SIDED|95.0|0.085|0.232|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.232|0.085|<0.001
73878015|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.201|||<|0.001|TWO_SIDED|95.0|0.127|0.275|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.275|0.127|<0.001
73878016|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.241|||<|0.001|TWO_SIDED|95.0|0.168|0.315|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.315|0.168|<0.001
73878017|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.277|||<|0.001|TWO_SIDED|95.0|0.204|0.351|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.351|0.204|<0.001
73878018|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.035|TWO_SIDED|95.0|0.005|0.152|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.152|0.005|0.035
74003673|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.2|||||TWO_SIDED|95.0|4.3|10.6||||||Serotype 1: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||10.6|4.3|
73878019|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.121||||0.001|TWO_SIDED|95.0|0.048|0.195|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.048|0.001
73878020|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.162|||<|0.001|TWO_SIDED|95.0|0.088|0.235|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.235|0.088|<0.001
73878021|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.256|TWO_SIDED|95.0|-0.031|0.116|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.116|-0.031|0.256
73878022|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.083||||0.027|TWO_SIDED|95.0|0.01|0.156|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.156|0.010|0.027
73878023|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.281|TWO_SIDED|95.0|-0.033|0.114|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.114|-0.033|0.281
73878024|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.141||||0.003|TWO_SIDED|95.0|0.05|0.232|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.232|0.050|0.003
74003674|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.6|||||TWO_SIDED|95.0|-0.3|5.9||||||Serotype 3: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.9|-0.3|
74037996|NCT01114373|147629370|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Friedman|||||||0.21
74037997|NCT01114373|147629371|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Friedman|||||||0.41
73878025|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.197|||<|0.001|TWO_SIDED|95.0|0.106|0.288|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.288|0.106|<0.001
73878026|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.249|||<|0.001|TWO_SIDED|95.0|0.157|0.34|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.340|0.157|<0.001
74037998|NCT01114373|147629372|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANOVA|||||||0.13
74037999|NCT01114373|147629373|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||ANOVA|||||||0.58
74038000|NCT01114373|147629374|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||ANOVA|||||||0.39
74039829|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.15||0.2786|TWO_SIDED|95.0|-0.44|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.44|0.2786
73878027|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.245|||<|0.001|TWO_SIDED|95.0|0.155|0.336|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.336|0.155|<0.001
73878028|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.348|||<|0.001|TWO_SIDED|95.0|0.258|0.439|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.439|0.258|<0.001
73878029|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.056||||0.222|TWO_SIDED|95.0|-0.034|0.147|||Mixed Models Analysis|||"week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.147|-0.034|0.222
73878030|NCT03084796|147295447|SUPERIORITY||Hazard Ratio, log|0.108||||0.02|TWO_SIDED|95.0|0.017|0.199|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.199|0.017|0.020
74038001|NCT03444870|147629385|SUPERIORITY||Difference in adjusted mean|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.0954|TWO_SIDED|95.0|-0.66|0.05|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline (BL) + Geographic Region + Disease Stage + AD Medication at BL + Apolipoprotein E, Allele e4 (APOE e4) + Baseline Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score + Baseline Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).||0.05|-0.66|0.0954
74003675|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.2|||||TWO_SIDED|95.0|2.1|6.9||||||Serotype 4: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.9|2.1|
74003676|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|5.1|||||TWO_SIDED|95.0|1.4|9.1||||||Serotype 5: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||9.1|1.4|
74038002|NCT03444870|147629387|SUPERIORITY||Difference in adjusted mean|-1.25|STANDARD_ERROR_OF_MEAN|0.65||0.0544|TWO_SIDED|95.0|-2.52|0.02|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.02|-2.52|0.0544
73878031|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.105||||0.022|TWO_SIDED|95.0|0.015|0.195|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.015|0.022
73878032|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.262|TWO_SIDED|95.0|-0.039|0.143|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.143|-0.039|0.262
73878033|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.29|TWO_SIDED|95.0|-0.041|0.138|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.138|-0.041|0.290
74003677|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.7|||||TWO_SIDED|95.0|1.7|6.1||||||Serotype 6A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.1|1.7|
74003678|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.4|||||TWO_SIDED|95.0|4.1|9.3||||||Serotype 6B: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||9.3|4.1|
73878034|NCT03084796|147295447|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.938|TWO_SIDED|95.0|-0.094|0.087|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.087|-0.094|0.938
73878035|NCT03084796|147295448|SUPERIORITY||Hazard Ratio (HR)|1.64||||0.002|TWO_SIDED|95.0|1.21|2.24|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using Cox proportional hazards model, including treatment, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and baseline FEV1 value as covariate."||2.24|1.21|0.002
74038003|NCT03444870|147629388|SUPERIORITY||Difference in adjusted mean|1.11|STANDARD_ERROR_OF_MEAN|0.81||0.1729|TWO_SIDED|95.0|-0.48|2.7|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Region + Disease Stage + AD Medication at BL + APOE e4.||2.70|-0.48|0.1729
74038004|NCT03444870|147629389|SUPERIORITY||Difference in adjusted mean|-0.86|STANDARD_ERROR_OF_MEAN|0.42||0.0425|TWO_SIDED|95.0|-1.68|-0.03|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.03|-1.68|0.0425
74003679|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.2|||||TWO_SIDED|95.0|5.4|11.6||||||Serotype 7F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.6|5.4|
74003680|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.8|||||TWO_SIDED|95.0|4.8|11.4||||||Serotype 9V: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.4|4.8|
74003681|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|11.2|||||TWO_SIDED|95.0|8.0|14.9||||||Serotype 14: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||14.9|8.0|
74003682|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.1|||||TWO_SIDED|95.0|0.9|5.7||||||Serotype 18C: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.7|0.9|
74003683|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.4|||||TWO_SIDED|95.0|0.3|3.1||||||Serotype 19A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.1|0.3|
74003684|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.4|||||TWO_SIDED|95.0|5.4|12.0||||||Serotype 19F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||12.0|5.4|
74003685|NCT00427895|147556129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|10.5|||||TWO_SIDED|95.0|6.8|14.7||||||Serotype 23F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||14.7|6.8|
74003686|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.31|||||TWO_SIDED|95.0|1.52|3.51||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.51|1.52|
74003687|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.37|||||TWO_SIDED|95.0|0.95|1.99||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.99|0.95|
74091000|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.78|STANDARD_ERROR_OF_MEAN|3.7688|||TWO_SIDED|95.0|-10.3|4.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.7|-10.3|
74003688|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.32|||||TWO_SIDED|95.0|1.47|3.64||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.64|1.47|
74003689|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.4|||||TWO_SIDED|95.0|0.92|2.12||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.12|0.92|
74003690|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.47|||||TWO_SIDED|95.0|1.01|2.16||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.16|1.01|
74003691|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.67|1.59||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.59|0.67|
74003692|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.34|||||TWO_SIDED|95.0|0.94|1.92||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.92|0.94|
74003693|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.33|||||TWO_SIDED|95.0|0.8|2.23||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.23|0.80|
74003694|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.68|1.59||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.59|0.68|
74038005|NCT03444870|147629390|SUPERIORITY||Difference in adjusted mean|0.32|STANDARD_ERROR_OF_MEAN|0.31||0.2904|TWO_SIDED|95.0|-0.28|0.93|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline + Geographic Region + Disease Stage + AD Medication at BL + APOE e4.||0.93|-0.28|0.2904
74038006|NCT03444870|147629391|SUPERIORITY||Difference in adjusted mean|-0.97|STANDARD_ERROR_OF_MEAN|0.6||0.1036|TWO_SIDED|95.0|-2.14|0.2|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.20|-2.14|0.1036
74038007|NCT03444870|147629392|SUPERIORITY||Difference in adjusted mean|-0.07|STANDARD_ERROR_OF_MEAN|0.37||0.8468|TWO_SIDED|95.0|-0.79|0.65|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.65|-0.79|0.8468
74038008|NCT03444870|147629393|SUPERIORITY||Difference in adjusted mean|0.2|STANDARD_ERROR_OF_MEAN|0.79||0.803|TWO_SIDED|95.0|-1.35|1.74|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||1.74|-1.35|0.8030
74038009|NCT03444870|147629394|SUPERIORITY||Difference in adjusted mean|1.0|STANDARD_ERROR_OF_MEAN|0.68||0.1439|TWO_SIDED|95.0|-0.34|2.34|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.34|-0.34|0.1439
74038010|NCT03444870|147629401|SUPERIORITY||Difference in adjusted means|-66.44|STANDARD_ERROR_OF_MEAN|4.171|<|0.0001|TWO_SIDED|95.0|-74.71|-58.16|||Mixed Model for Repeated Measures|||Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Type of Tracer + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||-58.16|-74.71|<.0001
74038011|NCT03444870|147629402|SUPERIORITY||Difference in adjusted mean|0.01|STANDARD_ERROR_OF_MEAN|0.023||0.7816|TWO_SIDED|95.0|-0.04|0.05|||Mixed Model for Repeated Measures|||Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.04|0.7816
74003695|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.15|||||TWO_SIDED|95.0|0.8|1.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.66|0.80|
74003696|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.79||||||95.0|1.07|3.0||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.00|1.07|
74038012|NCT03444870|147629402|SUPERIORITY||Difference in adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.018||0.6203|TWO_SIDED|95.0|-0.03|0.05|||Mixed Model for Repeated Measures|||Medial Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.03|0.6203
74038013|NCT03444870|147629402|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.7754|TWO_SIDED|95.0|-0.03|0.03|||Mixed Model for Repeated Measures|||Frontal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.03|-0.03|0.7754
74038014|NCT03444870|147629402|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.9022|TWO_SIDED|95.0|-0.05|0.05|||Mixed Model for Repeated Measures|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.05|0.9022
74038015|NCT03444870|147629403|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||||<.001
74003697|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.45|||||TWO_SIDED|95.0|0.95|2.24||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.24|0.95|
74038016|NCT03444870|147629404|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
74038017|NCT03444870|147629405|SUPERIORITY|||||||0.396|||||||ANCOVA|||||||0.396
74038018|NCT03444870|147629406|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
74038019|NCT01840228|147629473|SUPERIORITY||Risk Ratio (RR)|1.1||||0.74|TWO_SIDED|95.0|0.63|1.91|||Chi-squared|||||1.91|0.63|0.74
74038020|NCT01840228|147629474|SUPERIORITY||Risk Ratio (RR)|0.43||||0.13|TWO_SIDED|95.0|0.14|1.36|||Fisher Exact|||||1.36|0.14|0.13
74038021|NCT01840228|147629475|SUPERIORITY||Risk Ratio (RR)|1.5||||0.71|TWO_SIDED|95.0|0.51|4.43|||Fisher Exact|||||4.43|0.51|0.71
74038022|NCT01840228|147629476|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
74039830|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0058|TWO_SIDED|95.0|-0.68|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.68|0.0058
73878036|NCT03084796|147295448|SUPERIORITY||Hazard Ratio (HR)|2.18|||<|0.001|TWO_SIDED|95.0|1.61|2.94|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.94|1.61|<0.001
73878037|NCT03084796|147295448|SUPERIORITY||Hazard Ratio (HR)|2.79|||<|0.001|TWO_SIDED|95.0|2.07|3.78|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||3.78|2.07|<0.001
73878038|NCT03084796|147295448|SUPERIORITY||Hazard Ratio (HR)|3.07|||<|0.001|TWO_SIDED|95.0|2.27|4.15|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.15|2.27|<0.001
73878039|NCT03084796|147295448|SUPERIORITY||Hazard Ratio (HR)|3.1|||<|0.001|TWO_SIDED|95.0|2.3|4.17|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.17|2.30|<0.001
73878040|NCT03084796|147295448|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.052|TWO_SIDED|95.0|1.0|1.76|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.76|1.00|0.052
73878041|NCT03084796|147295448|SUPERIORITY||Hazard Ratio (HR)|1.7|||<|0.001|TWO_SIDED|95.0|1.28|2.26|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.26|1.28|<0.001
74003698|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.18|||||TWO_SIDED|95.0|1.53|3.12||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.12|1.53|
74039831|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.18||0.0365|TWO_SIDED|95.0|-0.71|-0.02|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.71|0.0365
73878042|NCT03084796|147295448|SUPERIORITY||Hazard Ratio (HR)|1.87|||<|0.001|TWO_SIDED|95.0|1.41|2.48|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.48|1.41|<0.001
73878043|NCT03084796|147295448|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.074|TWO_SIDED|95.0|0.98|1.69|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.69|0.98|0.074
73878044|NCT03084796|147295448|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.013|TWO_SIDED|95.0|1.08|1.85|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.85|1.08|0.013
73878045|NCT03084796|147295448|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.494|TWO_SIDED|95.0|0.84|1.44|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.44|0.84|0.494
73878046|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.017|TWO_SIDED|95.0|0.011|0.107|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.107|0.011|0.017
74003699|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.06|1.91||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||1.91|1.06|
73878047|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.001|TWO_SIDED|95.0|0.032|0.128|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|0.032|0.001
73878048|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.074|0.17|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.074|<0.001
73878049|NCT03084796|147295450|SUPERIORITY||Hazard Ratio, log|0.111|||<|0.001|TWO_SIDED|95.0|0.063|0.159|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.159|0.063|<0.001
73878050|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.074|0.17|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.074|<0.001
74003700|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.47|||||TWO_SIDED|95.0|1.71|3.55||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.55|1.71|
74003701|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.99|||||TWO_SIDED|95.0|1.45|2.74||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.74|1.45|
74003702|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.04|||||TWO_SIDED|95.0|1.5|2.76||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.76|1.50|
73878051|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.377|TWO_SIDED|95.0|-0.026|0.069|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.069|-0.026|0.377
74003703|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.85|||||TWO_SIDED|95.0|1.32|2.58||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.58|1.32|
74003704|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||TWO_SIDED|95.0|1.46|2.62||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.62|1.46|
74003705|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||TWO_SIDED|95.0|1.32|2.91||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.91|1.32|
74003706|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.36|||||TWO_SIDED|95.0|0.94|1.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||1.97|0.94|
74003707|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.08|2.03||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.03|1.08|
74003708|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|3.35|||||TWO_SIDED|95.0|2.19|5.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||5.12|2.19|
74003709|NCT00427895|147556131|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.0|||||TWO_SIDED|95.0|1.41|2.83||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.83|1.41|
74003710|NCT03401229|147556165|SUPERIORITY||Mean Difference (Net)|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.852|-0.289||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate. Both of the co-primary endpoints were tested at 0.01 (two-sided).|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||The primary analysis compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in total NPS and/or the change from baseline in NBS are similar between benralizumab and placebo. H1: Both of the change from baseline in total NPS and the change from baseline in NBS are different between benralizumab and placebo.||-0.289|-0.852|<0.0001
74003711|NCT03401229|147556166|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0048|TWO_SIDED|95.0|-0.458|-0.083||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate. Both of the co-primary endpoints were tested at 0.01 (two-sided).|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||The primary analysis compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in total NPS and/or the change from baseline in NBS are similar between benralizumab and placebo. H1: Both of the change from baseline in total NPS and the change from baseline in NBS are different between benralizumab and placebo.||-0.083|-0.458|0.0048
74003712|NCT03401229|147556167|SUPERIORITY||Mean Difference (Net)|-5.212||||0.0821|TWO_SIDED|95.0|-11.087|0.664||Since both primary endpoints were significant at significant level of 0.01 level, this endpoint was tested at significant level of 0.05.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in SNOT-22 total score is similar between benralizumab and placebo. H1: The change from baseline in SNOT-22 total score is different between benralizumab and placebo.||0.664|-11.087|0.0821
74039832|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0092|TWO_SIDED|95.0|-0.8|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.80|0.0092
73878052|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.01|TWO_SIDED|95.0|0.015|0.111|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.111|0.015|0.010
73878053|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.031|TWO_SIDED|95.0|0.005|0.1|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.100|0.005|0.031
74003713|NCT03401229|147556168|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.066|TWO_SIDED|95.0|0.55|1.02||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal because test for change from baseline in SNOT-22 at week 40 was not statistically significant.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||This endpoint compared the rate of incidence of first NP surgery and/or SCS use for NP between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.02|0.55|0.0660
74003714|NCT03401229|147556169|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.5008|TWO_SIDED|95.0|0.53|1.36||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||The endpoint compared the rate of incidence of first NP surgery between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio (HR) is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.36|0.53|0.5008
74003715|NCT03401229|147556170|SUPERIORITY||Mean Difference (Net)|-0.218||||0.0029|TWO_SIDED|95.0|-0.361|-0.074||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline DSS score of benralizumab with placebo. H0: The change from baseline in DSS score is similar between benralizumab and placebo. H1: The change from baseline in DSS score is different between benralizumab and placebo.||-0.074|-0.361|0.0029
74003716|NCT03401229|147556171|SUPERIORITY||Mean Difference (Net)|-0.475||||0.0054|TWO_SIDED|95.0|-0.81|-0.141||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in NPS is similar between benralizumab and placebo. H1: The change from baseline in NPS is different between benralizumab and placebo.||-0.141|-0.810|0.0054
74003717|NCT03401229|147556172|SUPERIORITY||Mean Difference (Net)|-0.287||||0.0032|TWO_SIDED|95.0|-0.477|-0.096||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in NBS is similar between benralizumab and placebo. H1: The change from baseline in NBS is different between benralizumab and placebo.||-0.096|-0.477|0.0032
74038023|NCT01295580|147629483|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"This is a non-inferiority test. The non-inferiority margin of +1.6 units corresponds to an 8% margin on the pain subscale (range 0-20)~Alpha inflation was controlled using pre-planned stepwise hypotheses testing (1) WOMAC Pain over 18 weeks then (2) over 26 weeks, (3) WOMAC Physical Function over 18 weeks then (4) over 26 weeks, (5) Subject Global Assessment over 18 weeks then (6) over 26 weeks, (7) WOMAC Knee Stiffness over 18 weeks then (8) over 26 weeks."|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-0.58|0.39||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the first step WOMAC pain over 18 week pain subscale primary analyses.||The second step is to test Durolane WOMAC pain non-inferior to Artz WOMAC pain over 26 weeks.||"Primary Hypothesis:~Ho: μDUR\[18\] - μArtz\[18\] ≥ +1.6 units Ha: μDUR\[18\] - μArtz\[18\] \< +1.6 units~Power Calculations:~Assume the over 18 weeks difference is 0mm, SD 20mm (5 on the Likert scale), 90% power, 2-sided test alpha 5%, and a 8mm non-inferiority margin (1.6 on the Likert scale), the sample size required is 132 subjects per group adjusted to 175 to hold power constant due to loss to follow-up and dropout."||0.39|-0.58|
74038024|NCT01295580|147629484|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +1.6 units corresponds to an 8% margin on the pain subscale (range 0-20)|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.56|0.37||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first pain over 18 weeks then pain over 26 weeks. This section reports the over 26 week pain subscale results.||The third ordered test is Durolane WOMAC physical function subscale non-inferior to Artz WOMAC physical function subscale over 18 weeks.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +1.6 units Ha: μDUR\[26\] - μArtz\[26\] \< +1.6 units||0.37|-0.56|
74038025|NCT01295580|147629485|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68).|Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-1.81|0.51||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week physical function results.||The fourth step is to test Durolane WOMAC physical function non-inferior to Artz physical function over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≥ +5.44 units Ha: μDUR\[18\] - μArtz\[18\] \< +5.44 units||0.51|-1.81|
73878054|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.042||||0.085|TWO_SIDED|95.0|-0.006|0.089|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.089|-0.006|0.085
74038026|NCT01295580|147629486|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68).|Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.69|0.53||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week physical function subscale results.||The fifth step is to test Durolane subject global assessment non-inferior to Artz global assessment over 18 weeks.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +5.44 units Ha: μDUR\[26\] - μArtz\[26\] \< +5.44 units||0.53|-1.69|
74038027|NCT01295580|147629487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin.|Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.15|0.45||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week subject global assessment results.||The sixth step is to test Durolane subject global assessment non-inferior to Artz subject global assessment over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≤ -0.8 units Ha: μDUR\[18\] - μArtz\[18\] \> -0.8 units||0.45|-0.15|
74038028|NCT01295580|147629488|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin.|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.16|0.43||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week subject global assessment results.||The seventh step is to test Durolane WOMAC knee stiffness non-inferior to Artz WOMAC knee stiffness over 18 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≤ -0.8 units Ha: μDUR\[18\] - μArtz\[18\] \> -0.8 units||0.43|-0.16|
74038029|NCT01295580|147629489|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8).|Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.33|0.05||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week knee stiffness subscale results.||The eight and last step is to test Durolane WOMAC knee stiffness non-inferior to Artz WOMAC knee stiffness over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≥ +0.64 units Ha: μDUR\[18\] - μArtz\[18\] \< +0.64 units||0.05|-0.33|
74038030|NCT01295580|147629490|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of 0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8).|Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-0.33|0.03||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week knee stiffness subscale results.||This is the eighth and last pre-planned hypothesis test.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +0.64 units Ha: μDUR\[26\] - μArtz\[26\] \< +0.64 units||0.03|-0.33|
74038031|NCT01148563|147629499|SUPERIORITY||Risk Ratio, log|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.094|TWO_SIDED|95.0|-0.65|0.05|||bootstrapping||The hypothesis test was based on ln(relative risk), with the tele-monitoring group value as the relative risk numerator and the control group value as the denominator. The standard error was generated by bootstrapping the sample.|||0.05|-0.65|0.094
74038032|NCT01148563|147629500|SUPERIORITY||Risk Ratio, log|0.7|STANDARD_ERROR_OF_MEAN|0.22||0.105|TWO_SIDED|95.0|0.45|1.08|||bootstrapping|The standard error was generated by bootstrapping the sample.|The hypothesis test was based on ln(relative risk) with the tele-monitoring group value as the numerator and the control group as the denominator.|||1.08|0.45|0.105
74038033|NCT01879319|147629501|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-2.4|||||TWO_SIDED|95.0|-11.2|6.1||||||||6.1|-11.2|
74038034|NCT01879319|147629502|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-2.9|9.7||||||||9.7|-2.9|
74038035|NCT04724733|147629512|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
74038036|NCT04724733|147629512|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
74038037|NCT04724733|147629512|SUPERIORITY|||||||0.0172|||||||t-test, 1 sided|||||||0.0172
74038038|NCT04724733|147629513|SUPERIORITY|||||||0.032|||||||t-test, 1 sided|||||||.0320
74038039|NCT04724733|147629513|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
74038040|NCT04724733|147629513|SUPERIORITY|||||||0.0008|||||||t-test, 1 sided|||||||0.0008
74038041|NCT04511819|147629522|OTHER||Risk Difference (RD)|-0.087||||0.8762|TWO_SIDED|95.0|-0.347|0.174|||Regression, Logistic|||||0.174|-0.347|0.8762
74038042|NCT00084929|147629528|OTHER||Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.853|0.933||||||Accuracy: ROC analysis Receiver-operating-characteristic (ROC) curves were estimated with the use of data pooled from the radiologists because of the small number of positive cases reviewed by each radiologist.||0.933|0.853|
74038043|NCT00084929|147629528|OTHER||"Sensitivity: P(T+|D+)"|0.9|||||TWO_SIDED|95.0|0.838|0.96|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|"Sensitivity, for each radiologist, was calculated as the percentage of patients with lesions that were larger than or equal to the prespecified threshold and that were detected on both colonoscopy and CT colonography.~The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated."||0.96|0.838|
74039833|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.2923|TWO_SIDED|95.0|-0.49|0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.49|0.2923
74003718|NCT03401229|147556173|SUPERIORITY||Mean Difference (Net)|-7.492||||0.0188|TWO_SIDED|95.0|-13.741|-1.243||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in SNOT-22 total score is similar between benralizumab and placebo. H1: The change from baseline in SNOT-22 total score is different between benralizumab and placebo.||-1.243|-13.741|0.0188
74003719|NCT03401229|147556174|SUPERIORITY||Mean Difference (Net)|-0.237||||0.0023|TWO_SIDED|95.0|-0.389|-0.084||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline DSS score of benralizumab with placebo. H0: The change from baseline in DSS score is similar between benralizumab and placebo. H1: The change from baseline in DSS score is different between benralizumab and placebo.||-0.084|-0.389|0.0023
74003720|NCT03401229|147556175|SUPERIORITY||Mean Difference (Net)|-0.856||||0.2375|TWO_SIDED|95.0|-2.281|0.57||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following WP (WP for NP surgery), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status.||This endpoint compared the changes from baseline LMS score of benralizumab with placebo. H0: The change from baseline in LMS score is similar between benralizumab and placebo. H1: The change from baseline in LMS score is different between benralizumab and placebo.||0.570|-2.281|0.2375
74003721|NCT03401229|147556176|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5419|TWO_SIDED|95.0|0.51|1.43||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with NP surgery between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||1.43|0.51|0.5419
74003722|NCT03401229|147556177|SUPERIORITY||Odds Ratio (OR)|0.69||||0.0913|TWO_SIDED|95.0|0.44|1.06||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with SCS\_NP between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||1.06|0.44|0.0913
74038044|NCT00084929|147629528|OTHER||"P(T-|D-)"|0.86|||||TWO_SIDED|95.0|0.813|0.9|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Specificity, for each radiologist, was calculated as the percentage of patients who did not have lesions larger than the prespecified threshold on colonoscopy as well as CT colonography The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated.||0.9|0.813|
74038045|NCT00084929|147629528|OTHER||"P(D+|T+)"|0.23|||||TWO_SIDED|95.0|0.194|0.273|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Positive Predictive Value (PPV) the positive predictive value was calculated as the percentage of patients with CT colonographic findings that were also seen on colonoscopy||0.273|0.194|
74038046|NCT00084929|147629528|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.99|0.998|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Negative Predictive Value (NPV) the negative predictive value was calculated as the percentage of patients with no CT colonographic findings larger than the prespecified threshold that were not detected on colonoscopy.||0.998|0.990|
74038047|NCT00084929|147629529|OTHER||Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.853|0.93||||||"Accuracy: ROC analysis CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.93|0.853|
74091001|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.27|STANDARD_ERROR_OF_MEAN|2.857|||TWO_SIDED|95.0|-7.0|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-7.0|
74003723|NCT03401229|147556178|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0362|TWO_SIDED|95.0|0.44|0.97||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with NP surgery or SCS\_NP between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||0.97|0.44|0.0362
74038048|NCT00084929|147629529|OTHER||"Sensitivity: P(T+|D+)"|0.9|||||TWO_SIDED|95.0|0.832|0.96|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|"Sensitivity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.96|0.832|
74038049|NCT00084929|147629529|OTHER||"P(T-|D-)"|0.86|||||TWO_SIDED|95.0|0.817|0.902|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|"Specificity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.902|0.817|
74091002|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.91|STANDARD_ERROR_OF_MEAN|3.1527|||TWO_SIDED|95.0|-13.2|-0.07|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-.07|-13.2|
74091003|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-4.22|STANDARD_ERROR_OF_MEAN|3.3457|||TWO_SIDED|95.0|-10.9|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.4|-10.9|
74091004|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.61|STANDARD_ERROR_OF_MEAN|3.2806|||TWO_SIDED|95.0|-10.1|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-10.1|
74003724|NCT03401229|147556179|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.1505|TWO_SIDED|95.0|0.53|1.1||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||The endpoint compared the rate of incidence of SCS\_NP use between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio (HR) is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.10|0.53|0.1505
74003725|NCT03401229|147556183|SUPERIORITY||Rate Ratio|0.79||||0.2189|TWO_SIDED|95.0|0.54|1.15||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Negative Bionomial Model|Model included treatment, US/non-US and prior use of SCS\_NP with total number of courses of SCS\_NP as outcome and log of follow-up time as an offset||The endpoint compared the rate of SCS\_NP use between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Rate ratio is benralizumab vs placebo and Rate ratio less than 1 indicates less likely of SCS\_NP use.||1.15|0.54|0.2189
74003726|NCT03401229|147556184|SUPERIORITY||Median Difference (Net)|-1.854||||0.0036|TWO_SIDED|95.0|-3.101|-0.608||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||-0.608|-3.101|0.0036
73878055|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.199|TWO_SIDED|95.0|-0.016|0.079|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.079|-0.016|0.199
74038050|NCT00084929|147629529|OTHER||"P(D+|T+)"|0.25|||||TWO_SIDED|95.0|0.209|0.292||||||"Positive Predictive Value (PPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.292|0.209|
74038051|NCT00084929|147629529|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.99|0.998||||||"Negative Predictive Value (NPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.998|0.990|
74038052|NCT00084929|147629530|OTHER||Area Under the Curve (AUC)|0.88|||||TWO_SIDED|95.0|0.842|0.913||||||Accuracy: ROC analysis||0.913|0.842|
73878056|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|-0.011||||0.657|TWO_SIDED|95.0|-0.058|0.037|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.037|-0.058|0.657
73878057|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.032||||0.246|TWO_SIDED|95.0|-0.022|0.086|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.086|-0.022|0.246
74003727|NCT03401229|147556185|SUPERIORITY||Mean Difference (Net)|-0.166||||0.0941|TWO_SIDED|95.0|-0.36|0.028||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||0.028|-0.360|0.0941
74003728|NCT03401229|147556186|SUPERIORITY||Mean Difference (Net)|-0.213||||0.0246|TWO_SIDED|95.0|-0.399|-0.027||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||-0.027|-0.399|0.0246
74003729|NCT03401229|147556187|SUPERIORITY||Mean Difference (Net)|0.672||||0.5833|TWO_SIDED|95.0|-1.73|3.074||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||3.074|-1.730|0.5833
74003730|NCT03401229|147556188|SUPERIORITY||Median Difference (Net)|2.684||||0.0619|TWO_SIDED|95.0|-0.134|5.502||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||5.502|-0.134|0.0619
74003731|NCT03401229|147556189|SUPERIORITY||Median Difference (Net)|-5.057||||0.102|TWO_SIDED|95.0|-11.129|1.015||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|Following WP (WP for NP surgery rescued subjects), model included treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||1.015|-11.129|0.1020
74038053|NCT00084929|147629530|OTHER||"Sensitivity: P(T+|D+)"|0.87|||||TWO_SIDED|95.0|0.803|0.929|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.929|0.803|
74038054|NCT00084929|147629530|OTHER||"P(T-|D-)"|0.87|||||TWO_SIDED|95.0|0.825|0.909|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.909|0.825|
73878058|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.001|TWO_SIDED|95.0|0.046|0.154|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.154|0.046|<0.001
74003732|NCT01122862|147556230|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21||||0.0915|TWO_SIDED|95.0|-0.45|0.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.03|-0.45|0.0915
74038055|NCT00084929|147629530|OTHER||"P(D+|T+)"|0.31|||||TWO_SIDED|95.0|0.256|0.355||||||Positive Predictive Value (PPV)||0.355|0.256|
74038056|NCT00084929|147629530|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.984|0.994||||||Negative Predictive Value (NPV)||0.994|0.984|
74038057|NCT00084929|147629531|OTHER||Area Under the Curve (AUC)|0.87|||||TWO_SIDED|95.0|0.833|0.902||||||Accuracy: ROC analysis||0.902|0.833|
74038058|NCT00084929|147629531|OTHER||"Sensitivity: P(T+|D+)"|0.84|||||TWO_SIDED|95.0|0.776|0.912|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.912|0.776|
74038059|NCT00084929|147629531|OTHER||"P(T-|D-)"|0.87|||||TWO_SIDED|95.0|0.831|0.914|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.914|0.831|
74038060|NCT00084929|147629531|OTHER||"P(D+|T+)"|0.35|||||TWO_SIDED|95.0|0.299|0.397||||||Positive Predictive Value (PPV)||0.397|0.299|
74038061|NCT00084929|147629531|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.98|0.992||||||Negative Predictive Value (NPV)||0.992|0.980|
73878059|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.119|||<|0.001|TWO_SIDED|95.0|0.064|0.173|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.173|0.064|<0.001
74038062|NCT00084929|147629532|OTHER||Area Under the Curve (AUC)|0.84|||||TWO_SIDED|95.0|0.81|0.878||||||Accuracy: ROC analysis||0.878|0.810|
73878060|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.088|0.196|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.196|0.088|<0.001
73878061|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.07|0.178|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.178|0.070|<0.001
74003733|NCT01122862|147556231|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|||<|0.0001|TWO_SIDED|95.0|1.42|1.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference in treatments being compared.||1.90|1.42|<0.0001
74038063|NCT00084929|147629532|OTHER||"Sensitivity: P(T+|D+)"|0.78|||||TWO_SIDED|95.0|0.711|0.849|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.849|0.711|
73878062|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.068||||0.014|TWO_SIDED|95.0|0.014|0.121|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.121|0.014|0.014
74038064|NCT00084929|147629532|OTHER||"P(T-|D-)"|0.88|||||TWO_SIDED|95.0|0.84|0.92|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.92|0.840|
74038065|NCT00084929|147629532|OTHER||"P(D+|T+)"|0.4|||||TWO_SIDED|95.0|0.335|0.463||||||Positive Predictive Value (PPV)||0.463|0.335|
74038066|NCT00084929|147629532|OTHER||"P(D-|T-)"|0.98|||||TWO_SIDED|95.0|0.971|0.984||||||Negative Predictive Value (NPV)||0.984|0.971|
74038067|NCT00084929|147629533|OTHER||Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.763|0.828||||||Accuracy: ROC analysis||0.828|0.763|
74038068|NCT00084929|147629533|OTHER||"Sensitivity: P(T+|D+)"|0.65|||||TWO_SIDED|95.0|0.579|0.727|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.727|0.579|
74038069|NCT00084929|147629533|OTHER||"P(T-|D-)"|0.89|||||TWO_SIDED|95.0|0.851|0.923|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.923|0.851|
74038070|NCT00084929|147629533|OTHER||"P(D+|T+)"|0.45|||||TWO_SIDED|95.0|0.389|0.513||||||Positive Predictive Value (PPV)||0.513|0.389|
74038071|NCT00084929|147629533|OTHER||"P(D-|T-)"|0.95|||||TWO_SIDED|95.0|0.941|0.965||||||Negative Predictive Value (NPV)||0.965|0.941|
74038072|NCT00084929|147629534|OTHER||"Sensitivity: P(T+|D+)"|0.84|STANDARD_ERROR_OF_MEAN|0.043|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion (\>=10mm))||||
74038073|NCT00084929|147629535|OTHER||"Sensitivity: P(T+|D+)"|0.82|STANDARD_ERROR_OF_MEAN|0.042|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion (\>=9mm))||||
73878063|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.002|TWO_SIDED|95.0|0.032|0.141|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.141|0.032|0.002
74038074|NCT00084929|147629536|OTHER||"Sensitivity: P(T+|D+)"|0.8|STANDARD_ERROR_OF_MEAN|0.041|||TWO_SIDED||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=8mm)||||
74038075|NCT00084929|147629537|OTHER||"Sensitivity: P(T+|D+)"|0.75|STANDARD_ERROR_OF_MEAN|0.042|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=7mm)||||
74038076|NCT00084929|147629538|OTHER||"Sensitivity: P(T+|D+)"|0.7|STANDARD_ERROR_OF_MEAN|0.046|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=6mm)||||
74038077|NCT00084929|147629539|OTHER||"Sensitivity: P(T+|D+)"|0.59|STANDARD_ERROR_OF_MEAN|0.045|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=5mm)||||
74038078|NCT00844649|147629541|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.617|0.835||P-value was based on a stratified log-rank test stratified by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine/gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.|||0.835|0.617|<0.0001
74038079|NCT00844649|147629542|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.581|0.821||P-value was based on a stratified log-rank test by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis (yes vs no)|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine / gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.|||0.821|0.581|<0.0001
74038080|NCT00844649|147629543|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|3.19|||<|0.0001|TWO_SIDED|95.0|2.178|4.662|||Chi-squared||Response rate ratio: albumin-bound paclitaxel + gemcitabine /gemcitabine alone|PA+G/PG = response rate ratio of albumin bound paclitaxel + gemcitabine / gemcitabine.||4.662|2.178|<0.0001
74003734|NCT01122862|147556232|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04||||0.6682|TWO_SIDED|95.0|-0.14|0.21|||ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.21|-0.14|0.6682
74003735|NCT01122862|147556232|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|0.74|||<|0.0001|TWO_SIDED|95.0|0.57|0.92||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.92|0.57|<0.0001
74003736|NCT01122862|147556233|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.2||||0.11|TWO_SIDED|95.0|-0.44|0.05||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.05|-0.44|0.1100
74038081|NCT03641547|147629553|OTHER||Post prob of tox at dose level 6|0.029|||||TWO_SIDED|95.0|0.0|0.165||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE-CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.165|0|
74038082|NCT03641547|147629554|OTHER||Post prob of tox at dose level 4|0.185|||||TWO_SIDED|95.0|0.042|0.397||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.397|0.042|
74038083|NCT00065442|147629565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.775||||0.032|TWO_SIDED|95.0|0.614|0.979|||Regression, Cox|Cox regression model with treatment, PSA (ln), and LDH (ln) as the independent variables, stratified by randomization strata.|sipuleucel-T/placebo|||0.979|0.614|0.032
74091005|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|3.5078|||TWO_SIDED|95.0|-7.8|6.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.2|-7.8|
74038084|NCT00065442|147629565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.766||||0.023|TWO_SIDED|95.0|0.608|0.965|||Log Rank|Stratified by randomization strata.|Cox regression model with treatment as the independent variable, stratified by randomization strata (sipuleucel-T/placebo)|||0.965|0.608|0.023
74003737|NCT01122862|147556233|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.68|||<|0.0001|TWO_SIDED|95.0|1.44|1.93||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||1.93|1.44|<0.0001
74003738|NCT01122862|147556234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03||||0.728||95.0|-0.16|0.23||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.23|-0.16|0.7280
74038085|NCT00065442|147629566|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.951||||0.628|TWO_SIDED|95.0|0.773|1.169|||Log Rank|Stratified by randomization strata|Cox regression model with treatment as the independent variable, stratified by randomization strata|||1.169|0.773|0.628
74038086|NCT01594333|147629567|SUPERIORITY||Cox Proportional Hazard|1.01||||0.91|TWO_SIDED|95.0|0.82|1.25||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status(diabetes or metabolic syndrome alone)|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.25|0.82|0.91
74038087|NCT01594333|147629568|SUPERIORITY||Cox Proportional Hazard|0.96||||0.67|TWO_SIDED|95.0|0.79|1.16||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status(metabolic syndrome alone or diabetes at enrollment).|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.16|0.79|0.67
73878064|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.11|||<|0.001|TWO_SIDED|95.0|0.057|0.163|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.163|0.057|<0.001
73878065|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.493|TWO_SIDED|95.0|-0.035|0.073|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.073|-0.035|0.493
73878066|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.042||||0.119|TWO_SIDED|95.0|-0.011|0.096|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.096|-0.011|0.119
74003739|NCT01122862|147556234|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.88|||<|0.0001|TWO_SIDED|95.0|0.68|1.08||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||1.08|0.68|<0.0001
74003740|NCT01287065|147556281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.377|||||TWO_SIDED|90.0|0.293|0.462|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg PM minus Placebo|||0.462|0.293|
74003741|NCT01287065|147556281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.422|||||TWO_SIDED|90.0|0.337|0.507|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg AM minus Placebo|||0.507|0.337|
74003742|NCT01287065|147556281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|||||TWO_SIDED|90.0|-0.125|0.036|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg AM minusFF/VI 100/25 µg PM|||0.036|-0.125|
74003743|NCT02875977|147556285|SUPERIORITY||Odds Ratio (OR)|1.794||||0.17|TWO_SIDED|95.0|0.782|4.119|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of completing half of the recommended PFPT visits between those assigned to standard versus experimental counseling||4.119|0.782|0.17
74038088|NCT01594333|147629569|SUPERIORITY||Cox Proportional Hazard|1.16||||0.32|TWO_SIDED|95.0|0.87|1.56||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (metabolic syndrome alone or diabetes at enrollment).|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.56|0.87|0.32
74038089|NCT01594333|147629570|SUPERIORITY||Cox Proportional Hazard|0.95||||0.57|TWO_SIDED|95.0|0.81|1.12||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (metabolic syndrome alone or diabetes) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.12|0.81|0.57
73878067|NCT03084796|147295450|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.392|TWO_SIDED|95.0|-0.03|0.077|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.077|-0.030|0.392
74003744|NCT02875977|147556286|SUPERIORITY||Odds Ratio (OR)|0.564||||0.056|TWO_SIDED|95.0|0.314|1.014|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of initiating PFPT between those assigned to standard versus experimental counseling||1.014|0.314|0.056
74003745|NCT02875977|147556287|SUPERIORITY||Odds Ratio (OR)|1.044||||0.9|TWO_SIDED|95.0|0.517|2.11|||Regression, Logistic|The statistical test of the hypothesis excludes the three individuals with unknown PFPT discharge status||The null hypothesis is that there is no difference in the odds of discharge from PFPT between those assigned to standard versus experimental counseling||2.110|0.517|0.90
74003746|NCT02875977|147556288|SUPERIORITY||Z-Score|-1.4262||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Among those who initiated PFPT therapy, the null hypothesis is that there is no difference in the number of days to initiating PFPT therapy between those assigned to standard versus experimental counseling||||0.16
74003747|NCT02875977|147556289|SUPERIORITY||Mean Difference (Final Values)|-4.456|STANDARD_ERROR_OF_MEAN|6.5481||0.5|TWO_SIDED|95.0|-17.6149|8.7028|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change from pre-PFPT to post-PFPT UDI-6 scores between those assigned to standard versus experimental counseling||8.7028|-17.6149|0.50
74003748|NCT01259726|147556291|SUPERIORITY_OR_OTHER_LEGACY||||||<=|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<=0.0001
74003749|NCT01259726|147556291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<0.0001
74003750|NCT01259726|147556291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<0.0001
74003751|NCT01259726|147556292|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.088|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.088
74003752|NCT01259726|147556292|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.002|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.002
74003753|NCT01259726|147556292|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.088|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.088
74003754|NCT01259726|147556293|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.054|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.054
73878068|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.109||||0.023|TWO_SIDED|95.0|0.015|0.203|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.203|0.015|0.023
74003755|NCT01259726|147556293|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.008|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.008
74003756|NCT01259726|147556293|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.101|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.101
74003757|NCT01259726|147556294|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.045|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.045
74038090|NCT01594333|147629571|SUPERIORITY||Cox Proportional Hazard|0.89||||0.54|TWO_SIDED|95.0|0.6|1.31||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, type of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.31|0.60|0.54
74038091|NCT01594333|147629572|SUPERIORITY||Cox Proportional Hazard|0.98||||0.8|TWO_SIDED|95.0|0.84|1.14||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time since qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.14|0.84|0.80
74038092|NCT01594333|147629574|SUPERIORITY||Cox Proportional Hazard|0.81||||0.31|TWO_SIDED|95.0|0.53|1.22||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.22|0.53|0.31
74038093|NCT01594333|147629575|SUPERIORITY||Cox Proportional Hazard|0.92||||0.38|TWO_SIDED|95.0|0.75|1.12||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.12|0.75|0.38
74038094|NCT00589979|147629580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.78||||0.1006||95.0|0.89|3.55||All statistical tests were 2-sided with a significance level of alpha=0.05.|Cox frailty model|Model included treatment, sequence, period, and first-order carryover as fixed effects and frailty; patient nested within sequence was frailty.|The Hazard Ratio (HR) provided is the ratio of Placebo to Lidoderm.|The two treatments were compared by time-varying relative hazards, associated P values, and 95% confidence intervals. Appropriate survival or hazard functions were calculated.||3.55|0.89|0.1006
74038095|NCT00589979|147629582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.1272||95.0|0.86|4.02||The logistic regression model for repeated measures used for this analysis included treatment, sequence, period, and first-order carry-over as fixed effects and repeated measures taken on patients nested within sequence.|Regression, Logistic|The results presented are reported in terms of odds ratios, corresponding 95% confidence intervals, and P-values for each fixed effect in the model.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|The proportion of patients who exited from the current treatment period prior to the 4-week planned duration was analyzed using a logistic regression model for repeated measures.||4.02|0.86|0.1272
74091006|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.05|STANDARD_ERROR_OF_MEAN|3.0965|||TWO_SIDED|95.0|-6.2|6.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.1|-6.2|
73878069|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.058|TWO_SIDED|95.0|-0.003|0.184|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.184|-0.003|0.058
74003758|NCT01259726|147556294|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.066|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.066
74003759|NCT01259726|147556294|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.045|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.045
74003760|NCT03421431|147556307|SUPERIORITY||Least Squares (LS) mean difference|12.46||||0.0495|TWO_SIDED|95.0|0.029|24.891|||ANCOVA|||||24.891|0.029|0.0495
74003761|NCT03421431|147556307|SUPERIORITY||LS mean difference|6.257||||0.3039|TWO_SIDED|95.0|-5.754|18.268|||ANCOVA|||||18.268|-5.754|0.3039
74003762|NCT03421431|147556307|SUPERIORITY||LS mean difference|6.203||||0.213|TWO_SIDED|95.0|-3.615|16.021|||ANCOVA|||||16.021|-3.615|0.2130
74003763|NCT03421431|147556308|SUPERIORITY||LS mean difference|4.717||||0.0009|TWO_SIDED|95.0|1.98|7.455|||ANCOVA|||||7.455|1.980|0.0009
74003764|NCT03421431|147556308|SUPERIORITY||LS mean difference|0.934||||0.4946|TWO_SIDED|95.0|-1.766|3.635|||ANCOVA|||||3.635|-1.766|0.4946
74003765|NCT03421431|147556308|SUPERIORITY||LS mean difference|3.783||||0.0005|TWO_SIDED|95.0|1.708|5.858|||ANCOVA|||||5.858|1.708|0.0005
74003766|NCT03421431|147556309|SUPERIORITY||LS mean difference|0.076||||0.2756|TWO_SIDED|95.0|-0.062|0.214|||ANCOVA|||||0.214|-0.062|0.2756
73878070|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.215|TWO_SIDED|95.0|-0.035|0.153|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.153|-0.035|0.215
73878071|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.051|TWO_SIDED|95.0|-0.001|0.187|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.187|-0.001|0.051
74003767|NCT03421431|147556309|SUPERIORITY||LS mean difference|-0.003||||0.9686|TWO_SIDED|95.0|-0.136|0.131|||ANCOVA|||||0.131|-0.136|0.9686
74003768|NCT03421431|147556309|SUPERIORITY||LS mean difference|0.079||||0.1406|TWO_SIDED|95.0|-0.026|0.184|||ANCOVA|||||0.184|-0.026|0.1406
74003769|NCT03421431|147556310|SUPERIORITY||LS mean difference|-0.125||||0.613|TWO_SIDED|95.0|-0.613|0.363|||ANCOVA|||||0.363|-0.613|0.6130
73878072|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.364|TWO_SIDED|95.0|-0.051|0.138|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.138|-0.051|0.364
73878073|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|-0.019||||0.694|TWO_SIDED|95.0|-0.112|0.074|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.074|-0.112|0.694
74003770|NCT03421431|147556310|SUPERIORITY||LS mean difference|-0.049||||0.8366|TWO_SIDED|95.0|-0.521|0.423|||ANCOVA|||||0.423|-0.521|0.8366
74003771|NCT03421431|147556310|SUPERIORITY||LS mean difference|-0.076||||0.7015|TWO_SIDED|95.0|-0.466|0.315|||ANCOVA|||||0.315|-0.466|0.7015
74003772|NCT03421431|147556311|SUPERIORITY||LS mean difference|-0.186||||0.3875|TWO_SIDED|95.0|-0.613|0.24|||ANCOVA|||||0.240|-0.613|0.3875
74003773|NCT03421431|147556311|SUPERIORITY||LS mean difference|-0.248||||0.2331|TWO_SIDED|95.0|-0.657|0.162|||ANCOVA|||||0.162|-0.657|0.2331
74003774|NCT03421431|147556311|SUPERIORITY||LS mean difference|0.061||||0.7164|TWO_SIDED|95.0|-0.272|0.395|||ANCOVA|||||0.395|-0.272|0.7164
74003775|NCT03421431|147556312|SUPERIORITY||LS mean difference|0.21|||<|0.0001|TWO_SIDED|95.0|0.11|0.311|||ANCOVA|||||0.311|0.110|<0.0001
74003776|NCT03421431|147556312|SUPERIORITY||LS mean difference|0.046||||0.348|TWO_SIDED|95.0|-0.051|0.143|||ANCOVA|||||0.143|-0.051|0.3480
74003777|NCT03421431|147556312|SUPERIORITY||LS mean difference|0.164|||<|0.0001|TWO_SIDED|95.0|0.085|0.243|||ANCOVA|||||0.243|0.085|<0.0001
74003778|NCT03421431|147556313|SUPERIORITY||LS mean difference|-0.299||||0.0897|TWO_SIDED|95.0|-0.645|0.047|||ANCOVA|||||0.047|-0.645|0.0897
74003779|NCT03421431|147556313|SUPERIORITY||LS mean difference|-0.251||||0.1411|TWO_SIDED|95.0|-0.586|0.085|||ANCOVA|||||0.085|-0.586|0.1411
74003780|NCT03421431|147556313|SUPERIORITY||LS mean difference|-0.048||||0.733|TWO_SIDED|95.0|-0.326|0.23|||ANCOVA|||||0.230|-0.326|0.7330
74003781|NCT03421431|147556314|SUPERIORITY||LS mean difference|51.873||||0.9143|TWO_SIDED|95.0|-901.574|1005.32|||ANCOVA|||||1005.320|-901.574|0.9143
74003782|NCT03421431|147556314|SUPERIORITY||LS mean difference|404.168||||0.3718|TWO_SIDED|95.0|-489.519|1297.854|||ANCOVA|||||1297.854|-489.519|0.3718
74003783|NCT03421431|147556314|SUPERIORITY||LS mean difference|-352.295||||0.3466|TWO_SIDED|95.0|-1091.308|386.719|||ANCOVA|||||386.719|-1091.308|0.3466
74003784|NCT03421431|147556315|SUPERIORITY||LS mean difference|0.173||||0.0003|TWO_SIDED|95.0|0.081|0.264|||ANCOVA|||||0.264|0.081|0.0003
74003785|NCT03421431|147556315|SUPERIORITY||LS mean difference|0.025||||0.5685|TWO_SIDED|95.0|-0.062|0.113|||ANCOVA|||||0.113|-0.062|0.5685
74003786|NCT03421431|147556315|SUPERIORITY||LS mean difference|0.147|||<|0.0001|TWO_SIDED|95.0|0.075|0.219|||ANCOVA|||||0.219|0.075|<0.0001
74003787|NCT03421431|147556316|SUPERIORITY||LS mean difference|-0.133||||0.0282|TWO_SIDED|95.0|-0.252|-0.015|||ANCOVA|||||-0.015|-0.252|0.0282
74003788|NCT03421431|147556316|SUPERIORITY||LS mean difference|-0.068||||0.2412|TWO_SIDED|95.0|-0.182|0.046|||ANCOVA|||||0.046|-0.182|0.2412
74003789|NCT03421431|147556316|SUPERIORITY||LS mean difference|-0.066||||0.1649|TWO_SIDED|95.0|-0.158|0.027|||ANCOVA|||||0.027|-0.158|0.1649
74003790|NCT03421431|147556317|SUPERIORITY||LS mean difference|0.009||||0.4357|TWO_SIDED|95.0|-0.014|0.032|||ANCOVA|||||0.032|-0.014|0.4357
74003791|NCT03421431|147556317|SUPERIORITY||LS mean difference|0.001||||0.8989|TWO_SIDED|95.0|-0.021|0.023|||ANCOVA|||||0.023|-0.021|0.8989
74003792|NCT03421431|147556317|SUPERIORITY||LS mean difference|0.008||||0.412|TWO_SIDED|95.0|-0.011|0.026|||ANCOVA|||||0.026|-0.011|0.4120
74003793|NCT03421431|147556318|SUPERIORITY||LS mean difference|-1.731||||0.0134|TWO_SIDED|95.0|-3.095|-0.368|||ANCOVA|||||-0.368|-3.095|0.0134
74003794|NCT03421431|147556318|SUPERIORITY||LS mean difference|-0.327||||0.6263|TWO_SIDED|95.0|-1.656|1.001|||ANCOVA|||||1.001|-1.656|0.6263
74003795|NCT03421431|147556318|SUPERIORITY||LS mean difference|-1.404||||0.0115|TWO_SIDED|95.0|-2.487|-0.322|||ANCOVA|||||-0.322|-2.487|0.0115
74003796|NCT03421431|147556319|SUPERIORITY||LS mean difference|-3.723||||0.4608|TWO_SIDED|95.0|-13.7|6.253|||ANCOVA|||||6.253|-13.700|0.4608
74003797|NCT03421431|147556319|SUPERIORITY||LS mean difference|-2.377||||0.6238|TWO_SIDED|95.0|-11.962|7.207|||ANCOVA|||||7.207|-11.962|0.6238
74003798|NCT03421431|147556319|SUPERIORITY||LS mean difference|-1.346||||0.7367|TWO_SIDED|95.0|-9.268|6.576|||ANCOVA|||||6.576|-9.268|0.7367
74003799|NCT03421431|147556320|SUPERIORITY||LS mean difference|-0.407||||0.8302|TWO_SIDED|95.0|-4.287|3.474|||ANCOVA|||||3.474|-4.287|0.8302
74003800|NCT03421431|147556320|SUPERIORITY||LS mean difference|-1.28||||0.5053|TWO_SIDED|95.0|-5.192|2.632|||ANCOVA|||||2.632|-5.192|0.5053
74003801|NCT03421431|147556320|SUPERIORITY||LS mean difference|0.873||||0.476|TWO_SIDED|95.0|-1.62|3.366|||ANCOVA|||||3.366|-1.620|0.4760
74003802|NCT03421431|147556321|SUPERIORITY||LS mean difference|-5.91||||0.0639|TWO_SIDED|95.0|-12.171|0.351|||ANCOVA|||||0.351|-12.171|0.0639
74003803|NCT03421431|147556321|SUPERIORITY||LS mean difference|-2.064||||0.4884|TWO_SIDED|95.0|-7.971|3.843|||ANCOVA|||||3.843|-7.971|0.4884
74003804|NCT03421431|147556321|SUPERIORITY||LS mean difference|-3.846||||0.1532|TWO_SIDED|95.0|-9.156|1.464|||ANCOVA|||||1.464|-9.156|0.1532
74003805|NCT03421431|147556322|SUPERIORITY||LS mean difference|-0.46||||0.0811|TWO_SIDED|95.0|-0.978|0.058|||ANCOVA|||||0.058|-0.978|0.0811
74003806|NCT03421431|147556322|SUPERIORITY||LS mean difference|0.117||||0.6312|TWO_SIDED|95.0|-0.367|0.601|||ANCOVA|||||0.601|-0.367|0.6312
74003807|NCT03421431|147556322|SUPERIORITY||LS mean difference|-0.577||||0.0099|TWO_SIDED|95.0|-1.011|-0.143|||ANCOVA|||||-0.143|-1.011|0.0099
74003808|NCT03421431|147556335|SUPERIORITY||LS mean difference|1.356||||0.112|TWO_SIDED|95.0|-0.322|3.034|||ANCOVA|||||3.034|-0.322|0.1120
74003809|NCT03421431|147556335|SUPERIORITY||LS mean difference|0.647||||0.4229|TWO_SIDED|95.0|-0.947|2.24|||ANCOVA|||||2.240|-0.947|0.4229
74003810|NCT03421431|147556335|SUPERIORITY||LS mean difference|0.71||||0.2764|TWO_SIDED|95.0|-0.577|1.996|||ANCOVA|||||1.996|-0.577|0.2764
74003811|NCT03421431|147556336|SUPERIORITY||LS mean difference|0.008||||0.5606|TWO_SIDED|95.0|-0.02|0.037|||ANCOVA|||||0.037|-0.020|0.5606
74003812|NCT03421431|147556336|SUPERIORITY||LS mean difference|0.023||||0.1002|TWO_SIDED|95.0|-0.004|0.05|||ANCOVA|||||0.050|-0.004|0.1002
74003813|NCT03421431|147556336|SUPERIORITY||LS mean difference|-0.014||||0.2002|TWO_SIDED|95.0|-0.036|0.008|||ANCOVA|||||0.008|-0.036|0.2002
74003814|NCT03421431|147556337|SUPERIORITY||LS mean difference|-178.787||||0.7014|TWO_SIDED|95.0|-1098.454|740.88|||ANCOVA|||||740.880|-1098.454|0.7014
74003815|NCT03421431|147556337|SUPERIORITY||LS mean difference|52.307||||0.907|TWO_SIDED|95.0|-830.934|935.547|||ANCOVA|||||935.547|-830.934|0.9070
74003816|NCT03421431|147556337|SUPERIORITY||LS mean difference|-231.094||||0.536|TWO_SIDED|95.0|-967.273|505.086|||ANCOVA|||||505.086|-967.273|0.5360
74003817|NCT03421431|147556338|SUPERIORITY||LS mean difference|-753.153||||0.2985|TWO_SIDED|95.0|-2183.92|677.614|||ANCOVA|||||677.614|-2183.920|0.2985
74003818|NCT03421431|147556338|SUPERIORITY||LS mean difference|139.107||||0.8413|TWO_SIDED|95.0|-1236.689|1514.902|||ANCOVA|||||1514.902|-1236.689|0.8413
74003819|NCT03421431|147556338|SUPERIORITY||LS mean difference|-892.26||||0.1168|TWO_SIDED|95.0|-2011.705|227.186|||ANCOVA|||||227.186|-2011.705|0.1168
74003820|NCT03421431|147556339|SUPERIORITY||LS mean difference|33.491|||<|0.0001|TWO_SIDED|95.0|17.984|48.998|||ANCOVA|||||48.998|17.984|<0.0001
74003821|NCT03421431|147556339|SUPERIORITY||LS mean difference|30.814|||<|0.0001|TWO_SIDED|95.0|15.802|45.825|||ANCOVA|||||45.825|15.802|<0.0001
74003822|NCT03421431|147556339|SUPERIORITY||LS mean difference|2.677||||0.6757|TWO_SIDED|95.0|-9.946|15.3|||ANCOVA|||||15.300|-9.946|0.6757
74003823|NCT03421431|147556340|SUPERIORITY||LS mean difference|21.3||||0.0134|TWO_SIDED|95.0|4.533|38.067|||ANCOVA|||||38.067|4.533|0.0134
74003824|NCT03421431|147556340|SUPERIORITY||LS mean difference|5.847||||0.4686|TWO_SIDED|95.0|-10.116|21.811|||ANCOVA|||||21.811|-10.116|0.4686
74003825|NCT03421431|147556340|SUPERIORITY||LS mean difference|15.453||||0.0181|TWO_SIDED|95.0|2.699|28.206|||ANCOVA|||||28.206|2.699|0.0181
74003826|NCT03421431|147556341|SUPERIORITY||LS mean difference|4.324||||0.0557|TWO_SIDED|95.0|-0.108|8.756|||ANCOVA|||||8.756|-0.108|0.0557
74003827|NCT03421431|147556341|SUPERIORITY||LS mean difference|2.305||||0.2867|TWO_SIDED|95.0|-1.955|6.566|||ANCOVA|||||6.566|-1.955|0.2867
74003828|NCT03421431|147556341|SUPERIORITY||LS mean difference|2.019||||0.2437|TWO_SIDED|95.0|-1.39|5.429|||ANCOVA|||||5.429|-1.390|0.2437
74003829|NCT03421431|147556342|SUPERIORITY||LS mean difference|0.019||||0.9913|TWO_SIDED|95.0|-3.491|3.53|||ANCOVA|||||3.530|-3.491|0.9913
74003830|NCT03421431|147556342|SUPERIORITY||LS mean difference|0.995||||0.553|TWO_SIDED|95.0|-2.323|4.314|||ANCOVA|||||4.314|-2.323|0.5530
74003831|NCT03421431|147556342|SUPERIORITY||LS mean difference|-0.976||||0.4729|TWO_SIDED|95.0|-3.665|1.713|||ANCOVA|||||1.713|-3.665|0.4729
74003832|NCT04147650|147556348|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1352|TWO_SIDED|95.0|0.62|7.62|||Regression, Logistic|||0.05 % VOS versus vehicle||7.62|0.62|0.1352
74003833|NCT04147650|147556348|SUPERIORITY||Odds Ratio (OR)|1.78||||0.2823|TWO_SIDED|95.0|0.49|6.45|||Regression, Logistic|||0.10% VOS versus vehicle||6.45|0.49|0.2823
74003834|NCT04147650|147556348|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0889|TWO_SIDED|95.0|0.7|8.3|||Regression, Logistic|||0.20% VOS versus vehicle||8.30|0.70|0.0889
74003835|NCT04147650|147556349|SUPERIORITY||Least square mean difference|-2.6||||0.3604|TWO_SIDED|95.0|-9.6|4.3|||ANCOVA|||0.05% VOS versus vehicle||4.3|-9.6|0.3604
74003836|NCT04147650|147556349|SUPERIORITY||Least square mean difference|-2.6||||0.3737|TWO_SIDED|95.0|-9.6|4.4|||ANCOVA|||0.10% VOS versus vehicle||4.4|-9.6|0.3737
74003837|NCT04147650|147556349|SUPERIORITY||Least square mean difference|1.8||||0.5307|TWO_SIDED|95.0|-5.1|8.6|||ANCOVA|||0.20% VOS versus vehicle||8.6|-5.1|0.5307
74003838|NCT01128738|147556368|SUPERIORITY_OR_OTHER||Percentage difference|50.2|||<|0.001|TWO_SIDED|95.0|38.1|62.3|||Fisher Exact||Percentage difference was estimated as BTX 50 U minus placebo.|||62.3|38.1|<0.001
74003839|NCT01178671|147556416|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
74003840|NCT01178671|147556417|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
74003841|NCT01178671|147556418|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||.14
74003842|NCT01178671|147556419|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||.50
74003843|NCT01178671|147556420|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||Mixed Models Analysis|||||||0.023
74003844|NCT01178671|147556421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||0.31
74003845|NCT01178671|147556422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7||||0.042|TWO_SIDED|95.0|1.1|19.9|||Mixed Models Analysis|||||19.9|1.1|0.042
74003846|NCT01178671|147556423|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
74003847|NCT01178671|147556424|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
73878074|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.297|TWO_SIDED|95.0|-0.143|0.044|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.044|-0.143|0.297
74003848|NCT01178671|147556425|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Mixed Models Analysis|||||||0.65
74003849|NCT01211197|147556435|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.59|STANDARD_DEVIATION|7.6|||TWO_SIDED|90.0|95.75|105.67|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Ratio calculated as FDC fasted divided by individual tablets fasted.||105.67|95.75|
74003850|NCT01211197|147556435|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.94|STANDARD_DEVIATION|8.0|||TWO_SIDED|90.0|89.85|100.33|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||100.33|89.85|
74003851|NCT01211197|147556436|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|99.31|STANDARD_DEVIATION|12.2|||TWO_SIDED|90.0|91.76|107.49|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||107.49|91.76|
74003852|NCT01211197|147556436|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|64.3|STANDARD_DEVIATION|20.6|||TWO_SIDED|90.0|55.97|73.87|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||73.87|55.97|
74003853|NCT01211197|147556437|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.94|STANDARD_DEVIATION|7.7|||TWO_SIDED|90.0|96.03|106.11|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||106.11|96.03|
74003854|NCT01211197|147556437|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.39|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|89.22|99.87|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||99.87|89.22|
74038096|NCT00589979|147629583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.0224||95.0|-1.01|-0.08||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||-0.08|-1.01|0.0224
74038097|NCT00589979|147629584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.2747||95.0|-0.31|1.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects regression||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||1.09|-0.31|0.2747
74003855|NCT01211197|147556438|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.13|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|95.59|111.25|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||111.25|95.59|
74003856|NCT01211197|147556438|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|96.96|STANDARD_DEVIATION|15.5|||TWO_SIDED|90.0|87.23|107.78|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||107.78|87.23|
74003857|NCT01211197|147556439|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|102.15|STANDARD_DEVIATION|13.0|||TWO_SIDED|90.0|93.87|111.15|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||111.15|93.87|
74003858|NCT01211197|147556439|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.67|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|91.7|110.51|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||110.51|91.70|
74003859|NCT01211197|147556440|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.49|STANDARD_DEVIATION|12.7|||TWO_SIDED|90.0|95.3|112.39|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||112.39|95.30|
74003860|NCT01211197|147556440|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|75.13|STANDARD_DEVIATION|24.5|||TWO_SIDED|90.0|63.68|88.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||88.64|63.68|
74003861|NCT00406653|147556465|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.611|TWO_SIDED|95.0|0.6|2.4||Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA 3mg/kg, \~10mg/kg, 30/\~10mg/kg). Only \~half intended number assigned to ABA 30/\~10 mg/kg arm and \~double intended number assigned to ABA 3 mg/kg arm|Cochran-Mantel-Haenszel|Second primary comparison (conditional on first): power=91%, sample size=134, 5% significance; expected PLA response rate= 25%, ABA/\~10 mg/kg=45%|All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/\~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA \~10 mg/kg vs PLA to be tested at 5% significance level. Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1).First comparison: power=99%,sample size=134,expected PLA response rate=25%, ABA 30/\~10 mg/kg=55%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata||2.4|0.6|0.611
74003862|NCT00406653|147556468|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.4|3.44||Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA mg/kg, \~10 mg/kg, 30/\~10 mg/kg). Only \~half intended number assigned to ABA 30/\~10 mg/kg arm and \~double intended number assigned to ABA 3 mg/kg arm|Cochran-Mantel-Haenszel|Second primary comparison (conditional on first): power=80%, sample size=134, 5% significance; expected PLA response rate= 15%, ABA/\~10 mg/kg=30%|All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/\~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA \~10 mg/kg vs PLA to be tested at 5% signficance level. Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1).First comparison: power=95%,sample size=134,expected PLA response rate=15%, ABA 30/\~10 mg/kg=35%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata||3.44|0.4|
74003863|NCT00406653|147556469|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.436
74003864|NCT00406653|147556476|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|95.0||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.112
74003865|NCT03513588|147556497|OTHER||Least Squares Mean Difference|-24.34|||<|0.001|TWO_SIDED|80.0|-31.28|-16.7|||ANCOVA|||||-16.70|-31.28|<0.001
74003866|NCT03513588|147556497|OTHER||Least Squares Mean Difference|-33.91|||<|0.001|TWO_SIDED|80.0|-39.78|-27.47|||ANCOVA|||||-27.47|-39.78|<0.001
74003867|NCT00585195|147556604|SUPERIORITY||Ratio of adjusted geometric means|131.72|||||TWO_SIDED|90.0|96.59|179.63||||||||179.63|96.59|
74038098|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4498||95.0|-0.8|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.36|-0.80|0.4498
74003868|NCT00585195|147556604|SUPERIORITY||Ratio of adjusted geometric means|239.03|||||TWO_SIDED|90.0|172.14|331.93||||||||331.93|172.14|
74003869|NCT00585195|147556604|SUPERIORITY||Ratio of adjusted geometric means|201.56|||||TWO_SIDED|90.0|139.33|291.58||||||||291.58|139.33|
74003870|NCT00585195|147556605|SUPERIORITY||Ratio of adjusted geometric means|216.19|||||TWO_SIDED|90.0|161.41|289.56||||||||289.56|161.41|
74003871|NCT00585195|147556605|SUPERIORITY||Ratio of adjusted geometric means|350.0|||||TWO_SIDED|90.0|141.09|868.23||||||||868.23|141.09|
74003872|NCT00585195|147556605|SUPERIORITY||Ratio of adjusted geometric means|365.43|||||TWO_SIDED|90.0|263.22|507.31||||||||507.31|263.22|
74003873|NCT00585195|147556608|SUPERIORITY||Ratio of adjusted geometric mean|15.57|||||TWO_SIDED|90.0|10.89|22.26||||||||22.26|10.89|
74038099|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.1065||95.0|-1.11|0.11||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sharp: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.11|-1.11|0.1065
74003874|NCT00585195|147556609|SUPERIORITY||Ratio of adjusted geometric mean|20.64|||||TWO_SIDED|90.0|14.59|29.18||||||||29.18|14.59|
74003875|NCT00585195|147556611|SUPERIORITY||Ratio of adjusted geometric means|157.4|||||TWO_SIDED|90.0|136.89|180.97||||||||180.97|136.89|
74003876|NCT00585195|147556612|SUPERIORITY||Ratio of adjusted geometric means|132.81|||||TWO_SIDED|90.0|119.1|148.1||||||||148.10|119.10|
73878075|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|-0.016||||0.734|TWO_SIDED|95.0|-0.109|0.077|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.077|-0.109|0.734
74003877|NCT00822523|147556670|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 1 H0: There is no change in mean force between baseline and day 1 HA: There is change in mean force between baseline and day 1||||0.61
74003878|NCT00822523|147556670|SUPERIORITY_OR_OTHER|||||||0.787|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 2 H0: There is no change in mean force between baseline and day 2 HA: There is change in mean force between baseline and day 2||||0.787
74003879|NCT00822523|147556670|SUPERIORITY_OR_OTHER|||||||0.234|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 4 H0: There is no change in mean force between baseline and day 4 HA: There is change in mean force between baseline and day 4||||0.234
74003880|NCT00822523|147556670|SUPERIORITY_OR_OTHER|||||||0.256|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 14 H0: There is no change in mean force between baseline and day 14 HA: There is change in mean force between baseline and day 14||||0.256
74003881|NCT00822523|147556670|SUPERIORITY_OR_OTHER|||||||0.292|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 21 H0: There is no change in mean force between baseline and day 21 HA: There is change in mean force between baseline and day 21||||0.292
74003882|NCT00822523|147556670|SUPERIORITY_OR_OTHER|||||||0.589|||||||t-test, 2 sided|||Two sample t-test comparing baseline and month 4 H0: There is no change in mean force between baseline and month 4 HA: There is change in mean force between baseline and month 4||||0.589
74039834|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.2231|TWO_SIDED|95.0|-0.51|0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.51|0.2231
74003883|NCT00822523|147556671|SUPERIORITY_OR_OTHER|||||||0.636|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in the three baseline force measurements H0: There no significant difference in the three baseline force measurements HA: There is a significant difference in the three baseline force measurements||||0.636
74003884|NCT00822523|147556671|SUPERIORITY_OR_OTHER|||||||0.178|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in baseline force by treatment arm. H0: There is no difference in mean baseline force by treatment arm HA: There is a difference in mean baseline force by treatment arm||||0.178
74003885|NCT00822523|147556672|SUPERIORITY_OR_OTHER|||||||0.995|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing percent change (from baseline) in force for contrast of day 14 and day 21 H0: There is no difference in percent change in force between day 14 and day 21 HA: There is a difference in percent change in force between day 14 and day 21||||0.995
74003886|NCT00822523|147556672|SUPERIORITY_OR_OTHER|||||||0.2088|||||||Repeated measure ANOVA|||"Repeated measure ANOVA assessing percent change in force from baseline for day 14 and 21 by treatment arm.~H0: There is no significant different in percent change in force by treatment arm HA: There is a significant different in percent change in force by treatment arm"||||0.2088
74003887|NCT00822523|147556674|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
74003888|NCT00822523|147556674|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
74003889|NCT00822523|147556674|SUPERIORITY_OR_OTHER||r value|0.8||||0.104|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.104
74003890|NCT00822523|147556676|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
74003891|NCT00822523|147556676|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
74003892|NCT00822523|147556676|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
74003893|NCT00822523|147556677|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
74003894|NCT00822523|147556677|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
74003895|NCT00822523|147556677|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.188
74003896|NCT00822523|147556678|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
74003897|NCT00822523|147556678|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
74003898|NCT00822523|147556678|SUPERIORITY_OR_OTHER||r value|0.5||||0.391|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.391
74003899|NCT00822523|147556679|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
74003900|NCT00822523|147556679|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
74003901|NCT00822523|147556679|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
74003902|NCT00822523|147556680|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
74003903|NCT00822523|147556680|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
74003904|NCT00822523|147556680|SUPERIORITY_OR_OTHER||r value|0.4||||0.505|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.505
74003905|NCT00822523|147556681|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
74003906|NCT00822523|147556681|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
74003907|NCT00822523|147556681|SUPERIORITY_OR_OTHER||r value|0.8||||0.104|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.104
74003908|NCT00822523|147556682|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
74003909|NCT00822523|147556682|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
74003910|NCT00822523|147556682|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
74003911|NCT00822523|147556683|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
74003912|NCT00822523|147556683|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
74003913|NCT00822523|147556683|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.188
74003914|NCT00822523|147556684|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
74003915|NCT00822523|147556684|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
74003916|NCT00822523|147556684|SUPERIORITY_OR_OTHER||r value|0.5||||0.391|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.391
74003917|NCT00822523|147556685|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
74003918|NCT00822523|147556685|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
74003919|NCT00822523|147556685|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
74003920|NCT00822523|147556686|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
74003921|NCT00822523|147556686|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
74003922|NCT00822523|147556686|SUPERIORITY_OR_OTHER||r value|0.4||||0.505|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.505
74003923|NCT05269355|147556797|OTHER||Hazard Ratio (HR)|0.61||||0.0017|TWO_SIDED|95.0|0.45|0.83|||Regression, Cox|||||0.83|0.45|0.0017
74003924|NCT00081497|147556803|SUPERIORITY_OR_OTHER||Change in Slope Mean|-0.029||||0.013||95.0|-0.051|-0.007|||Mixed Models Analysis|Mixed effects model with a population level (fixed effect) intercept and slope and a subject level (random effect) intercept and slope.||The statistical analysis represents the primary outcome measure results.||-0.007|-0.051|0.0130
74003925|NCT00081497|147556804|SUPERIORITY_OR_OTHER||Mean Difference|-6.787||||0.0027||95.0|-11.123|-2.45|||Mixed Effects Model|||Statistical Analysis 1 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup \>60.||-2.450|-11.123|0.0027
74003926|NCT00081497|147556804|SUPERIORITY_OR_OTHER||Mean Difference|2.33||||0.1268||95.0|-0.685|5.345|||Mixed Effects Model|||Statistical Analysis 2 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup ≤ 60.||5.345|-0.685|0.1268
74003927|NCT01078220|147556809|SUPERIORITY_OR_OTHER||Relative Risk|6.0|||||TWO_SIDED|95.0|3.91|9.21|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|||9.21|3.91|
74003928|NCT01078220|147556809|SUPERIORITY_OR_OTHER||Relative Risk|2.88|||||TWO_SIDED|95.0|1.18|7.08|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|||7.08|1.18|
74003929|NCT01078220|147556813|SUPERIORITY_OR_OTHER||Relative Risk|1.64|||||TWO_SIDED|95.0|1.17|2.3|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.||2.3|1.17|
74003930|NCT01078220|147556813|SUPERIORITY_OR_OTHER||Relative Risk|1.05|||||TWO_SIDED|95.0|0.82|1.35|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.||1.35|0.82|
74003931|NCT01078220|147556813|SUPERIORITY_OR_OTHER||Relative Risk|1.02|||||TWO_SIDED|95.0|0.53|1.98|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.||1.98|0.53|
74003932|NCT01078220|147556813|SUPERIORITY_OR_OTHER||Relative Risk|0.78|||||TWO_SIDED|95.0|0.5|1.21|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.||1.21|0.5|
74003933|NCT03824639|147556818|OTHER|Cohen's d will be used to estimate the effect size for comparing change in outcome measurements over 6 months in the exercise group to the control group. This effect size will be used for sample size calculations.|Cohen's d|0.37|||||TWO_SIDED|||||||||||||
74003934|NCT03824639|147556819|OTHER|Cohen's d will be used to estimate the effect size for comparing change in outcome measurements over 6 months in the exercise group to the control group. This effect size will be used for sample size calculations.|Cohen's d|0.18|||||TWO_SIDED|||||||||||||
74003935|NCT01340196|147556820|SUPERIORITY_OR_OTHER||Geometric mean ratio|121.89|STANDARD_DEVIATION|14.1|||TWO_SIDED|90.0|111.714|132.999|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|||132.999|111.714|
74003936|NCT01340196|147556821|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.72|STANDARD_DEVIATION|17.2|||TWO_SIDED|90.0|85.215|105.29|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||105.290|85.215|
74003937|NCT01340196|147556822|SUPERIORITY_OR_OTHER||Geometric mean ratio|147.12|STANDARD_DEVIATION|14.6||||90.0|134.482|160.943|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||160.943|134.482|
74003938|NCT01340196|147556823|SUPERIORITY_OR_OTHER||Geometric mean ratio|77.88|STANDARD_DEVIATION|13.4|||TWO_SIDED|90.0|71.24|85.15|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||85.15|71.24|
74003939|NCT01340196|147556824|SUPERIORITY_OR_OTHER||Geometric mean ratio|81.73|STANDARD_DEVIATION|20.1|||TWO_SIDED|90.0|71.56|93.34|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||93.34|71.56|
74003940|NCT01340196|147556825|SUPERIORITY_OR_OTHER||Geometric mean ratio|75.27|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|68.71|82.45|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||82.45|68.71|
74003941|NCT00081770|147556863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.567||95.0|0.79|1.14||Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).|||1.14|0.79|0.567
74003942|NCT00081770|147556863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.195||95.0|0.9|1.3||Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).|||1.30|0.90|0.195
74003943|NCT00081770|147556865|SUPERIORITY_OR_OTHER||Percentage of participants|39.9||||||95.0|36.9|42.9|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||42.9|36.9|
74003944|NCT00081770|147556865|SUPERIORITY_OR_OTHER||Percentage of participants|36.0||||||95.0|33.1|39.0|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||39.0|33.1|
74003945|NCT00081770|147556865|SUPERIORITY_OR_OTHER||Percentage of participants|45.0||||||95.0|42.0|48.1|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||48.1|42.0|
74003946|NCT00601419|147556869|SUPERIORITY_OR_OTHER||||||=|0.556|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years and \>=65 years in the frequency of treatment related adverse events."||||=0.556
74003947|NCT00601419|147556870|SUPERIORITY_OR_OTHER||||||=|0.845|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."||||=0.845
74038100|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.0484||95.0|-0.94|0.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Hot: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||-0.00|-0.94|0.0484
74039835|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.16||0.0724|TWO_SIDED|95.0|-0.6|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.60|0.0724
74003948|NCT00601419|147556871|SUPERIORITY_OR_OTHER||||||=|0.038|TWO_SIDED||||||Fisher Exact|||"The null hypothesis is that there is no difference between With TSH deficiency and Without TSH deficiency in the frequency of treatment related adverse events."||||=0.038
74003949|NCT00601419|147556872|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past history. The null hypothesis is that there is no difference between With past history and Without past history in the frequency of treatment related adverse events."||||=0.013
74003950|NCT00601419|147556873|SUPERIORITY_OR_OTHER||||||=|0.037|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no association between Initial Dose and the frequency of treatment related adverse events."||||=0.037
74003951|NCT00601419|147556873|SUPERIORITY_OR_OTHER||||||=|0.063|TWO_SIDED||||||Cochran-Armitage Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of initial dose."||||=0.063
74003952|NCT00601419|147556875|SUPERIORITY_OR_OTHER||||||=|0.019|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years of age and \>=65 years of age in the efficacy of somatropin."||||=0.019
74003953|NCT00601419|147556876|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between male and female in the efficacy of somatropin."||||=1.000
74003954|NCT00601419|147556877|SUPERIORITY_OR_OTHER||||||=|0.037|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was ACTH deficiency. The null hypothesis is that there is no difference between With ACTH deficiency and Without ACTH deficiency in the efficacy of somatropin."||||=0.037
74003955|NCT02245672|147556881|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||MGR001 (Test) vs Placebo||||<0.0001
74003956|NCT02245672|147556881|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established.For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||Advair Diskus (Reference) vs Placebo||||<0.0001
74003957|NCT02245672|147556882|EQUIVALENCE|A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).|Ratio (MGR001/Advair Diskus)|1.12|||||TWO_SIDED|90.0|1.016|1.237|||||Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for the FEV1 AUEC0-12 clinical endpoint|Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).||1.237|1.016|
73878076|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.514|TWO_SIDED|95.0|-0.124|0.062|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.062|-0.124|0.514
73878077|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.957|TWO_SIDED|95.0|-0.09|0.095|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.095|-0.090|0.957
74003958|NCT02245672|147556883|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||MGR001 (Test) vs Placebo||||<0.0001
74003959|NCT02245672|147556883|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||Advair Diskus (Reference) vs Placebo||||<0.0001
74003960|NCT02245672|147556884|EQUIVALENCE|A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).|Ratio (MGR001/Advair Diskus)|1.069|||||TWO_SIDED|90.0|0.938|1.22|||||Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for change from baseline in trough FEV1 endpoint on Day 29|Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).||1.220|0.938|
74003961|NCT01097785|147556892|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student's t-test|||||||<0.05
74003962|NCT01097785|147556893|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student's t-test|||||||<0.05
74003963|NCT01765192|147556894|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.039||0.013|TWO_SIDED|95.0|0.0219|0.1795|||ANCOVA|||The primary endpoint was analyzed using an analysis of covariance model adapted for the crossover design. The following fixed factors and covariates were included in the model: Treatment, sequence, period, and baseline FEV1 measurement of the respective treatment period. The reported analysis results are for the 2 crossover treatment periods combined.||0.1795|0.0219|0.013
74003964|NCT01765192|147556895|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.129|TWO_SIDED|95.0|-0.0185|0.1422||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FVC measurement as the covariate.|ANCOVA|||||0.1422|-0.0185|0.129
74003965|NCT01765192|147556896|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.056||0.032|TWO_SIDED|95.0|0.0113|0.2364||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FEF measurement as the covariate.|ANCOVA|||||0.2364|0.0113|0.032
74003966|NCT01765192|147556897|SUPERIORITY_OR_OTHER||LS Mean Difference|7.21|STANDARD_ERROR_OF_MEAN|15.105||0.635||95.0|-23.0531|37.466||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA|||||37.4660|-23.0531|0.635
74003967|NCT01765192|147556898|SUPERIORITY_OR_OTHER||LS Mean Difference|13.62|STANDARD_ERROR_OF_MEAN|5.206||0.011|TWO_SIDED|95.0|3.1896|24.0553||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA|||||24.0553|3.1896|0.011
74003968|NCT01765192|147556899|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.089||0.025|TWO_SIDED|95.0|-0.385|-0.0271||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Daytime Asthma Symptom Score as the covariate.|ANCOVA|||||-0.0271|-0.3850|0.025
74003969|NCT01765192|147556900|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.075||0.217|TWO_SIDED|95.0|-0.2426|0.0563||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Nighttime Asthma Symptoms measurement as the covariate.|ANCOVA|||||0.0563|-0.2426|0.217
73878078|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.479|TWO_SIDED|95.0|-0.06|0.127|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.127|-0.060|0.479
74003970|NCT01535014|147556916|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
74003971|NCT01535014|147556916|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
74003972|NCT01535014|147556916|SUPERIORITY|||||||0.0007|||||||Cochran-Mantel-Haenszel|||||||0.0007
74003973|NCT01535014|147556917|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
74003974|NCT01535014|147556917|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
74003975|NCT01535014|147556918|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
74003976|NCT01535014|147556918|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
74003977|NCT01535014|147556919|SUPERIORITY||||||<|0.05||||||For week 12, 16, 20, 24|Chi-squared|||||||<0.05
74003978|NCT01535014|147556919|SUPERIORITY||||||<|0.05||||||For week 16, 20, 24|Chi-squared|||||||<0.05
74003979|NCT01535014|147556920|SUPERIORITY|||||||0.019|||||||ANCOVA|||||||0.019
74003980|NCT01535014|147556920|SUPERIORITY|||||||0.043|||||||ANCOVA|||||||0.043
73878079|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.687|TWO_SIDED|95.0|-0.079|0.12|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.120|-0.079|0.687
74003981|NCT01535014|147556921|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.20
74003982|NCT01535014|147556921|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.75
74003983|NCT01535014|147556922|SUPERIORITY|||||||0.02|||||||ANCOVA|||SF-36 Mental Health Domain||||0.02
74003984|NCT01535014|147556922|SUPERIORITY|||||||0.63|||||||ANCOVA|||SF-36 Mental Health Domain||||0.63
74003985|NCT01535014|147556922|SUPERIORITY|||||||0.6|||||||ANCOVA|||SF-36 Physical Health Domain||||0.60
74003986|NCT01535014|147556922|SUPERIORITY|||||||0.98|||||||ANCOVA|||SF-36 Physical Health Domain||||0.98
74003987|NCT02349451|147556923|SUPERIORITY||response rate difference|39.8|||<|0.001|TWO_SIDED|95.0|17.2|57.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact|||||57.7|17.2|<0.001
74038101|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.4973||95.0|-0.93|0.46||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Dull: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.46|-0.93|0.4973
74003988|NCT02349451|147556923|SUPERIORITY||response rate difference|50.3|||<|0.001|TWO_SIDED|95.0|28.1|67.4||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact|||||67.4|28.1|<0.001
74003989|NCT02349451|147556924|SUPERIORITY||response rate difference|-3.3||||0.723|TWO_SIDED|95.0|-18.5|12.1||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||12.1|-18.5|0.723
74003990|NCT02349451|147556924|SUPERIORITY||response rate difference|7.3||||0.215|TWO_SIDED|95.0|-7.4|21.6||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||21.6|-7.4|0.215
74003991|NCT02349451|147556925|SUPERIORITY||response rate difference|24.1||||0.021|TWO_SIDED|95.0|3.9|39.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||39.3|3.9|0.021
74039836|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.19||0.4776|TWO_SIDED|95.0|-0.5|0.23|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.50|0.4776
74003992|NCT02349451|147556925|SUPERIORITY||response rate difference|-0.9||||0.611|TWO_SIDED|95.0|-16.5|14.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||14.8|-16.5|0.611
74003993|NCT02349451|147556925|SUPERIORITY||response rate difference|40.9|||<|0.001|TWO_SIDED|95.0|20.1|55.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||55.8|20.1|<0.001
74003994|NCT02349451|147556925|SUPERIORITY||response rate difference|15.9||||0.039|TWO_SIDED|95.0|-0.3|31.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||31.3|-0.3|0.039
74003995|NCT02349451|147556926|SUPERIORITY||response rate difference|18.4||||0.034|TWO_SIDED|95.0|1.5|29.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||29.7|1.5|0.034
74003996|NCT02349451|147556926|SUPERIORITY||response rate difference|7.3||||0.185|TWO_SIDED|95.0|-5.8|19.9||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||19.9|-5.8|0.185
74003997|NCT02349451|147556926|SUPERIORITY||response rate difference|27.3||||0.004|TWO_SIDED|95.0|9.6|39.0||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||39.0|9.6|0.004
74003998|NCT02349451|147556926|SUPERIORITY||response rate difference|16.2||||0.017|TWO_SIDED|95.0|2.3|29.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||29.3|2.3|0.017
74003999|NCT02349451|147556927|SUPERIORITY||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test|||||||<0.001
74004000|NCT02349451|147556927|SUPERIORITY|||||||0.561||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test|||||||0.561
74004001|NCT02349451|147556927|SUPERIORITY||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test|||||||<0.001
74004002|NCT02349451|147556927|SUPERIORITY|||||||0.106||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test|||||||0.106
74004003|NCT02349451|147556928|SUPERIORITY||Least squares mean difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.58|-0.57||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.57|-1.58|<0.001
73878080|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.195|TWO_SIDED|95.0|-0.034|0.165|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.165|-0.034|0.195
73878081|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.03|TWO_SIDED|95.0|0.011|0.212|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.212|0.011|0.030
73878082|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.112|TWO_SIDED|95.0|-0.019|0.179|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.179|-0.019|0.112
73878083|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.147|TWO_SIDED|95.0|-0.026|0.174|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.174|-0.026|0.147
73878084|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.37|TWO_SIDED|95.0|-0.054|0.144|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.144|-0.054|0.370
73878085|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.091||||0.074|TWO_SIDED|95.0|-0.009|0.19|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.190|-0.009|0.074
74004004|NCT02349451|147556928|SUPERIORITY||Least squares mean difference|-0.13||||0.479|TWO_SIDED|95.0|-0.48|0.23||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.23|-0.48|0.479
74004005|NCT02349451|147556928|SUPERIORITY||Least squares mean difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.9|-0.89||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.89|-1.90|<0.001
74004006|NCT02349451|147556928|SUPERIORITY||Least squares mean difference|-0.45||||0.012|TWO_SIDED|95.0|-0.81|-0.1||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.10|-0.81|0.012
74004007|NCT02349451|147556929|SUPERIORITY||Least squares mean difference|-1.17|||<|0.001|TWO_SIDED|95.0|-1.81|-0.53||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.53|-1.81|<0.001
73878086|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.233|TWO_SIDED|95.0|-0.039|0.158|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.158|-0.039|0.233
73878087|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.369|TWO_SIDED|95.0|-0.054|0.145|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.145|-0.054|0.369
73878088|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.773|TWO_SIDED|95.0|-0.084|0.112|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.112|-0.084|0.773
74004008|NCT02349451|147556929|SUPERIORITY||Least squares mean difference|-0.09||||0.696|TWO_SIDED|95.0|-0.54|0.36||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.36|-0.54|0.696
74004009|NCT02349451|147556929|SUPERIORITY||Least squares mean difference|-1.41|||<|0.001|TWO_SIDED|95.0|-2.04|-0.77||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.77|-2.04|<0.001
74004010|NCT02349451|147556929|SUPERIORITY||Least squares mean difference|-0.33||||0.151|TWO_SIDED|95.0|-0.77|0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.12|-0.77|0.151
74004011|NCT02349451|147556930|SUPERIORITY||Least squares mean difference|-3.17|||<|0.001|TWO_SIDED|95.0|-4.14|-2.19||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-2.19|-4.14|<0.001
74004012|NCT02349451|147556930|SUPERIORITY||Least squares mean difference|-0.81||||0.021|TWO_SIDED|95.0|-1.51|-0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.12|-1.51|0.021
73878089|NCT03084796|147295451|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.536|TWO_SIDED|95.0|-0.13|0.068|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.068|-0.130|0.536
73878090|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.05||||0.848|TWO_SIDED|95.0|0.62|1.77|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analysis based on logistic regression model - multiple logistic regression model, with treatment, US regions, smoking status at screening, and BDI as covariates."||1.77|0.62|0.848
74004013|NCT02349451|147556930|SUPERIORITY||Least squares mean difference|-2.73|||<|0.001|TWO_SIDED|95.0|-3.7|-1.75||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-1.75|-3.70|<0.001
74004014|NCT02349451|147556930|SUPERIORITY||Least squares mean difference|-0.37||||0.288|TWO_SIDED|95.0|-1.06|0.32||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.32|-1.06|0.288
74004015|NCT02683941|147556957|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.866|TWO_SIDED|95.0|0.48|1.95|||Log Rank|||The hazard ratio and the 95% confidence interval (CI) were estimated using a Cox proportional hazards model, stratified for interactive web response system (IWRS) tumour subtype (typical versus \[vs\] atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.95|0.48|0.866
74004016|NCT02683941|147556958|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.837|TWO_SIDED|95.0|0.48|1.88|||Log Rank|||The hazard ratio and the 95% CI were estimated using a Cox proportional hazards model, stratified for IWRS tumour subtype (typical vs atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.88|0.48|0.837
74004017|NCT02683941|147556959|OTHER||Percentage difference|14.0|||||TWO_SIDED|95.0|-10.97|37.86||||||The treatment difference compares lanreotide to placebo (central review). The 95% exact unconditional CI was used for ORR difference.||37.86|-10.97|
74004018|NCT02683941|147556959|OTHER||Percentage difference|2.0|||||TWO_SIDED|95.0|-22.69|26.53||||||The treatment difference compares lanreotide to placebo (local review). The 95% exact unconditional CI was used for ORR difference.||26.53|-22.69|
74038102|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.3966||95.0|-0.16|0.41||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cold: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.41|-0.16|0.3966
74038103|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.6941||95.0|-0.53|0.35||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sensitive: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.35|-0.53|0.6941
74038104|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.5664||95.0|-0.45|0.82||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tender: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.82|-0.45|0.5664
74038105|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.6871||95.0|-0.55|0.37||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Itchy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.37|-0.55|0.6871
74038106|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.2318||95.0|-1.08|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Shocking: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.27|-1.08|0.2318
74004019|NCT02683941|147556960|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.582|TWO_SIDED|95.0|0.5|1.5|||Log Rank|||The hazard ratio and the 95% CI were estimated using a Cox proportional hazards model, stratified for IWRS tumour subtype (typical vs atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.50|0.50|0.582
74004020|NCT00343252|147557007|SUPERIORITY_OR_OTHER|||||||0.642||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month endpoint.||||0.642
74004021|NCT00343252|147557008|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline at the 12-month endpoint.||||0.683
74004022|NCT00343252|147557009|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month endpoint.||||0.809
74038107|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.3383||95.0|-0.64|0.22||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Numb: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.22|-0.64|0.3383
74038108|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.874||95.0|-0.63|0.73||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Electrical: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.73|-0.63|0.8740
73878091|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.35||||0.264|TWO_SIDED|95.0|0.8|2.28|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.28|0.80|0.264
74004023|NCT00343252|147557010|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month endpoint.||||0.986
74004024|NCT00343252|147557011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.746|TWO_SIDED|95.0|0.85|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 6-month endpoint.||1.26|0.85|0.746
74004025|NCT00343252|147557012|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.719|TWO_SIDED|95.0|0.86|1.25||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 12-month endpoint.||1.25|0.86|0.719
74004026|NCT00343252|147557013|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.681|TWO_SIDED|95.0|0.86|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction for average back pain at the 6-month endpoint.||1.26|0.86|0.681
74004027|NCT00343252|147557014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.789|TWO_SIDED|95.0|0.86|1.23||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in average back pain at the 12-month endpoint.||1.23|0.86|0.789
74004028|NCT00343252|147557015|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between the treatment groups in the proportion of participants with a reduction in disability at the 3-month endpoint.||||0.968
74004029|NCT00343252|147557016|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 6-month endpoint.||||0.568
74004030|NCT00343252|147557017|SUPERIORITY_OR_OTHER|||||||0.932||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 12-month endpoint.||||0.932
74004031|NCT00343252|147557018|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 6-month endpoint.||||0.814
74039837|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.19||0.1482|TWO_SIDED|95.0|-0.64|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.64|0.1482
73878092|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.29||||0.343|TWO_SIDED|95.0|0.76|2.18|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.18|0.76|0.343
74004032|NCT00343252|147557019|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 12-month endpoint.||||0.572
74038109|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.999||95.0|-0.54|0.54||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tingling: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.54|-0.54|0.9990
74038110|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.4183||95.0|-0.85|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cramping: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.36|-0.85|0.4183
74091007|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.05|STANDARD_ERROR_OF_MEAN|2.5649|||TWO_SIDED|95.0|-6.1|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-6.1|
74004033|NCT00343252|147557022|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value is for responder versus non-responder.|Chi-squared|||||||0.600
74004034|NCT00343252|147557023|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||P-value is for responder versus non-responder.|Chi-squared|||||||0.399
74004035|NCT00343252|147557024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.453|TWO_SIDED|95.0|0.89|1.28|||Log Rank|||||1.28|0.89|0.453
74004036|NCT00343252|147557025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.353|TWO_SIDED|95.0|0.91|1.3|||Log Rank|||||1.30|0.91|0.353
74004037|NCT00343252|147557026|SUPERIORITY_OR_OTHER|||||||0.943||95.0|||||ANCOVA|||||||0.943
74004038|NCT00343252|147557027|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||ANCOVA|||||||0.553
74004039|NCT01054846|147557035|SUPERIORITY_OR_OTHER||z value|2.696|||<|0.01|TWO_SIDED||||||Chi-squared|||Differences between Survey 1 and Survey 2||||<0.01
74004040|NCT01054846|147557035|SUPERIORITY_OR_OTHER||z value|1.351|||>|0.05|TWO_SIDED||||||Chi-squared|||Difference between Survey 1 and Survey 2||||>0.05
74004041|NCT02446886|147557037|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.04|TWO_SIDED||||||t-test, 2 sided|||Previously published reproducibility of our MWF imaging (FAST-T2) has been established to be +/- 2.0 Our hypothesis for this study was the monthly ACTH would lead to greater remylination in acute MS lesions. However, to reach this goal, improvement must be beyond established reproducibility. Note: Since MWF is a fraction of myelin water to total water, it does not have a unit.||||0.04
74004042|NCT02446886|147557042|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.077|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed-effects models were implemented to assess the variables of interest (lesion MWF) among patients randomized to once versus the monthly ACTH treatment group. The modeling strategy accounts for multiple lesions per patient, repeated measurements (longitudinal analysis) and the following covariates were always considered: patient age, gender, disease duration, individual T2w lesion volume, time on disease modifying treatments (DMT) prior to enrollment, and DMT during the study.|Linear mixed-effects models were implemented|||0.077
74004043|NCT02858349|147557052|SUPERIORITY||Mean Difference (Net)|0.13||||0.0042|TWO_SIDED|95.0|0.05|0.21|||Mixed Models Analysis|||||0.21|0.05|0.0042
73878093|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.74||||0.042|TWO_SIDED|95.0|1.02|2.98|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.98|1.02|0.042
74004044|NCT04508023|147557134|SUPERIORITY||Cox Proportional Hazard|1.16||||0.626|TWO_SIDED|95.0|0.63|2.15|||Log Rank|Log rank test stratified by the time from COVID-19 positive test to randomization.||||2.15|0.63|0.626
74004045|NCT00178126|147557139|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||||||0.04
74004046|NCT02988622|147557140|SUPERIORITY||Mean Difference (Net)|0.1205|STANDARD_DEVIATION|0.5499||0.0492|TWO_SIDED||||||t-test, 2 sided|||||||0.0492
74004047|NCT02988622|147557141|SUPERIORITY||Mean Difference (Net)|0.241|STANDARD_DEVIATION|0.0817||0.0817|TWO_SIDED||||||t-test, 2 sided|||||||0.0817
74004048|NCT02988622|147557142|SUPERIORITY||Mean Difference (Net)|0.3659|STANDARD_DEVIATION|1.7951||0.0686|TWO_SIDED||||||t-test, 2 sided|||||||0.0686
74004049|NCT02988622|147557143|SUPERIORITY||Mean Difference (Net)|-0.0843|STANDARD_DEVIATION|1.5789||0.6278|TWO_SIDED||||||t-test, 2 sided|||||||0.6278
74004050|NCT02988622|147557144|SUPERIORITY||Mean Difference (Net)|0.3373|STANDARD_DEVIATION|1.7619||0.0848|TWO_SIDED||||||t-test, 2 sided|||||||0.0848
74004051|NCT02988622|147557145|SUPERIORITY||Mean Difference (Net)|0.2195|STANDARD_DEVIATION|2.0788||0.3418|TWO_SIDED||||||t-test, 2 sided|||||||0.3418
74004052|NCT02988622|147557146|SUPERIORITY||Mean Difference (Net)|0.2375|STANDARD_DEVIATION|1.5528||0.1752|TWO_SIDED||||||t-test, 2 sided|||||||0.1752
74004053|NCT02988622|147557148|SUPERIORITY||Mean Difference (Net)|0.3824|STANDARD_DEVIATION|1.5685||0.0281|TWO_SIDED||||||t-test, 2 sided|||||||0.0281
74004054|NCT06020118|147557149|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.938|TWO_SIDED|95.0||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||0.938
74004055|NCT06020118|147557149|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.451||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.451
74004056|NCT06020118|147557149|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.819||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||0.819
74004057|NCT06020118|147557149|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.5||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||0.500
74004058|NCT06020118|147557149|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||<.001
74004059|NCT06020118|147557149|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.001
74004060|NCT06020118|147557149|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||<0.001
74004061|NCT06020118|147557149|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||<0.001
74004062|NCT06020118|147557150|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.894||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||0.894
74004063|NCT06020118|147557150|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.104||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.104
74004064|NCT06020118|147557150|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.815||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||0.815
74004065|NCT06020118|147557150|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.814||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||0.814
74004066|NCT06020118|147557150|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||<0.001
74004067|NCT06020118|147557150|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||<0.001
74004068|NCT06020118|147557150|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||<0.001
73878094|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.2||||0.503|TWO_SIDED|95.0|0.71|2.02|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.02|0.71|0.503
73878095|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.28||||0.354|TWO_SIDED|95.0|0.76|2.16|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.16|0.76|0.354
73878096|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.22||||0.447|TWO_SIDED|95.0|0.73|2.07|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.07|0.73|0.447
73878097|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.66||||0.064|TWO_SIDED|95.0|0.97|2.83|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.83|0.97|0.064
74004069|NCT06020118|147557150|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||<0.001
74004070|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.699||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H1N1)pdm09||||0.699
74004071|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.88||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H1N1)pdm09||||0.880
74004072|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.72||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H3N2)||||0.720
74004073|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.238||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H3N2)||||0.238
74004074|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.28||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Victoria||||0.280
74004075|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.094||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Victoria||||0.094
74004076|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.216||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Yamagata||||0.216
74004077|NCT06020118|147557151|SUPERIORITY|P values and confidence intervals for the geometric mean titer ratio were estimated using a generalized estimating equation logistic regression accounting for site clustering.||||||0.436||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Yamagata||||0.436
73878098|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|0.96||||0.867|TWO_SIDED|95.0|0.57|1.62|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.62|0.57|0.867
73878099|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.29||||0.347|TWO_SIDED|95.0|0.76|2.22|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.22|0.76|0.347
73878100|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.35||||0.269|TWO_SIDED|95.0|0.79|2.32|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.32|0.79|0.269
73878101|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.92||||0.018|TWO_SIDED|95.0|1.12|3.3|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure.~Analysis based on logistic regression model - multiple logistic regression model, with treatment, US regions, smoking status at screening, and BDI as covariates."||3.30|1.12|0.018
74004078|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.615||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H1N1)pdm09||||0.615
73878102|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|2.59|||<|0.001|TWO_SIDED|95.0|1.5|4.49|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.49|1.50|<0.001
73878103|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.75|5.44|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.44|1.75|<0.001
73878104|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|1.94|6.02|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.02|1.94|<0.001
73878105|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|2.45||||0.001|TWO_SIDED|95.0|1.41|4.26|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.26|1.41|0.001
74004079|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H1N1)pdm09||||<0.001
74004080|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.87||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H3N2)||||0.870
74004081|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001|||||||Regression, Linear|GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.||Post-vaccine: Antigen A(H3N2)||||<0.001
74004082|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.64||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Victoria||||0.640
74004083|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Victoria||||<0.001
74004084|NCT06020118|147557151|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.444||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Yamagata||||0.444
74004085|NCT06020118|147557151|SUPERIORITY|P values and confidence intervals for the geometric mean titer ratio were estimated using a generalized estimating equation logistic regression accounting for site clustering.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Yamagata||||<0.001
74004086|NCT06020118|147557152|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.793||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H1N1)pdm09||||0.793
74004087|NCT06020118|147557152|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.326||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H3N2)||||0.326
74004088|NCT06020118|147557152|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.933||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Victoria||||0.933
73878106|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.35||||0.284|TWO_SIDED|95.0|0.78|2.35|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.35|0.78|0.284
73878107|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.61||||0.103|TWO_SIDED|95.0|0.91|2.84|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.84|0.91|0.103
73878108|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.78||||0.045|TWO_SIDED|95.0|1.01|3.14|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||3.14|1.01|0.045
73878109|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.19||||0.557|TWO_SIDED|95.0|0.67|2.12|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.12|0.67|0.557
73878110|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.32||||0.345|TWO_SIDED|95.0|0.74|2.34|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.34|0.74|0.345
73878111|NCT03084796|147295452|SUPERIORITY||Odds Ratio (OR)|1.11||||0.732|TWO_SIDED|95.0|0.61|2.0|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.00|0.61|0.732
73878112|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.666|TWO_SIDED|95.0|-0.52|0.81|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the BDI, BDI by visit interaction as covariates."||0.81|-0.52|0.666
73878113|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.224|TWO_SIDED|95.0|-0.25|1.07|||Mixed Models Analysis|||"week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.07|-0.25|0.224
73878114|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.239|TWO_SIDED|95.0|-0.27|1.06|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.27|0.239
73878115|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.019|TWO_SIDED|95.0|0.13|1.46|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.46|0.13|0.019
73878116|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.124|TWO_SIDED|95.0|-0.14|1.19|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.19|-0.14|0.124
74004089|NCT06020118|147557152|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.424||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Yamagata||||0.424
74004090|NCT06020118|147557152|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H1N1)pdm09||||<0.001
74038111|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.8227||95.0|-0.71|0.57||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Radiating: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.57|-0.71|0.8227
73878117|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.432|TWO_SIDED|95.0|-0.39|0.92|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.92|-0.39|0.432
73878118|NCT03084796|147295453|SUPERIORITY||Mean Difference (Net)|0.25||||0.454|TWO_SIDED|95.0|-0.41|0.91|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.91|-0.41|0.454
73878119|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.053|TWO_SIDED|95.0|-0.01|1.31|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.31|-0.01|0.053
73878120|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.973|TWO_SIDED|95.0|-0.67|0.65|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.65|-0.67|0.973
74004091|NCT06020118|147557152|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H3N2)||||<0.001
74004092|NCT06020118|147557152|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Victoria||||<0.001
73878121|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.247|TWO_SIDED|95.0|-0.27|1.04|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.04|-0.27|0.247
73878122|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.235|TWO_SIDED|95.0|-0.26|1.06|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.26|0.235
73878123|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.071|TWO_SIDED|95.0|-0.05|1.28|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.28|-0.05|0.071
73878124|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.004|TWO_SIDED|95.0|0.32|1.64|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.64|0.32|0.004
73878125|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|1.01||||0.003|TWO_SIDED|95.0|0.35|1.68|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.68|0.35|0.003
73878126|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED|95.0|0.86|2.18|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.18|0.86|<0.001
73878127|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|1.08||||0.002|TWO_SIDED|95.0|0.41|1.75|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.75|0.41|0.002
73878128|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.271|TWO_SIDED|95.0|-0.29|1.03|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.03|-0.29|0.271
73878129|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.235|TWO_SIDED|95.0|-0.26|1.06|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.26|0.235
73878130|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.007|TWO_SIDED|95.0|0.25|1.56|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.56|0.25|0.007
74004093|NCT06020118|147557152|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Yamagata||||<0.001
74004094|NCT01281969|147557176|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.97||||0.44|TWO_SIDED|95.0|-7.1|3.15||p-value is unadjusted. a priori threshold for statistical significance is .05|ANCOVA|F(1,34)=0.62, p=.44||Analysis of covariance model controlling for baseline scores. A priori power calculations based on the Perlmutter et al. study (IVIG effect size 1.2) suggested that a sample size of 16 per group would be sufficient to detect an effect size of 1.0 with 80% power.||3.15|-7.1|0.44
74038112|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.587||95.0|-0.48|0.85||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Throbbing: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.85|-0.48|0.5870
74004095|NCT01281969|147557177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||p-value is not adjusted.|Wilcoxon (Mann-Whitney)|Mean rank sum in the placebo group = 19.92; mean rank sum in the IVIG group = 15.97. Z = -1.18, p=.12||The Wilcoxon two-sample test was used to compare CGI-Improvement ratings (an ordinal variable) at week 6. Power calculation was based on CYBOCS as primary outcome.||||.12
74004096|NCT01281969|147557178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||p-value is not adjusted for multiple comparisons.|Chi-squared|X2 = 0.72, p=.40||Chi-squared test was used to compare distribution of responders by randomization group. Power calculation was based on CY-BOCS (primary outcome).||||.40
73878131|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.923|TWO_SIDED|95.0|-0.63|0.69|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.69|-0.63|0.923
73878132|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.108|TWO_SIDED|95.0|-0.12|1.19|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.19|-0.12|0.108
73878133|NCT03084796|147295453|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.134|TWO_SIDED|95.0|-0.16|1.16|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.16|-0.16|0.134
74004097|NCT01257425|147557204|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin defined as 0.8 to 1.25|Ratio of AUC values|0.977|||||TWO_SIDED|90.0|0.88|1.08|||ANCOVA|||||1.08|0.88|
73878134|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|7.88||||0.022|TWO_SIDED|95.0|1.13|14.63|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||14.63|1.13|0.022
74004098|NCT01257425|147557205|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.932|||||TWO_SIDED|90.0|0.82|1.06|||ANCOVA|||||1.06|0.82|
74038113|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2181||95.0|-1.15|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Aching: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.27|-1.15|0.2181
74039838|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.19||0.3249|TWO_SIDED|95.0|-0.56|0.18|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.56|0.3249
74004099|NCT01257425|147557206|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.91|||||TWO_SIDED|90.0|0.81|1.02|||ANCOVA|||||1.02|0.81|
74004100|NCT01257425|147557208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.85|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||||0.11|-0.09|0.85
74004101|NCT01257425|147557209|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Log Rank|||||||0.98
74004102|NCT01257425|147557210|SUPERIORITY_OR_OTHER|||||||0.84|||||||Log Rank|||||||0.84
74004103|NCT01182194|147557211|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.5|||||TWO_SIDED|90.0|85.53|100.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.03|85.53|
74004104|NCT01182194|147557212|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.76|||||TWO_SIDED|90.0|95.66|101.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.96|95.66|
74004105|NCT01182194|147557213|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.47|||||TWO_SIDED|90.0|95.35|101.7|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.70|95.35|
74004106|NCT01182194|147557214|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.45|||||TWO_SIDED|90.0|94.36|109.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||109.08|94.36|
74004107|NCT01182194|147557215|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.54|||||TWO_SIDED|90.0|94.55|102.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.71|94.55|
74004108|NCT01182194|147557216|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|90.0|96.07|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.46|96.07|
74004109|NCT04262817|147557217|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.01
74004110|NCT04262817|147557217|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.34
74004111|NCT04262817|147557218|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.38
74004112|NCT04262817|147557218|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.85
74004113|NCT04262817|147557219|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.39
74004114|NCT04262817|147557219|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.77
74004115|NCT04262817|147557220|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.43
74004116|NCT04262817|147557220|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.05
74004117|NCT04262817|147557221|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.05
74004118|NCT04262817|147557221|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.04
74004119|NCT04262817|147557222|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.01
74004120|NCT04262817|147557222|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.38
74004121|NCT02668185|147557227|SUPERIORITY|Generalised linear mixed model with a Poisson error structure|Mean Difference (Net)|29.66|||<|0.0001|TWO_SIDED|95.0|17.39|42.87||Intention to treat adjusted means.|generalised linear mixed model with a Po|Adjusted for intention to treat||||42.87|17.39|<0.0001
74004122|NCT02668185|147557228|SUPERIORITY||Mean Difference (Net)|50.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
74004123|NCT02668185|147557229|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74004124|NCT02668185|147557230|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
74004125|NCT02668185|147557231|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
74039839|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.1997|TWO_SIDED|95.0|-0.62|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.62|0.1997
74004126|NCT00883051|147557285|OTHER|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||<|0.0001|||||||Cochran-Armitage test for trend|||||||<0.0001
74004127|NCT00883051|147557286|OTHER|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||=|0.0006|||||||Cochran-Armitage test for trend]|||||||=0.0006
74004128|NCT02618642|147557309|SUPERIORITY|||||||0.3879|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared||||0.3879
74004129|NCT02618642|147557309|SUPERIORITY|||||||0.5361|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter were compared||||0.5361
74004130|NCT02618642|147557310|SUPERIORITY|||||||0.4669|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) vs the control group (placebo) (n=15) were compared.||||0.4669
74004131|NCT02618642|147557310|SUPERIORITY|||||||0.4161|||||||Kruskal-Wallis|||||||0.4161
74004132|NCT02618642|147557311|SUPERIORITY|||||||0.9596|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.||||0.9596
74004133|NCT02618642|147557311|SUPERIORITY|||||||0.0907|||||||Kruskal-Wallis|||||||0.0907
74004134|NCT02618642|147557312|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.||||0.0110
74004135|NCT02618642|147557312|SUPERIORITY|||||||0.1165|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter (groups v, x, y,||||0.1165
74004136|NCT02618642|147557313|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||he results in the irradiated group (n=45) and the control group (n=15) were compared||||0.0200
74004137|NCT02618642|147557313|SUPERIORITY|comparison was conducted of the results obtained with a different filter (groups v, x, y,||||||0.0014|||||||Kruskal-Wallis|||||||0.0014
74004138|NCT03373201|147557314|SUPERIORITY||Difference between LS means|60.3|||<|0.0001|TWO_SIDED|95.0|44.0|76.7|||ANOVA|||||76.7|44.0|<.0001
74004139|NCT03373201|147557315|SUPERIORITY||Difference between LS Means.|85.5|||<|0.0001|TWO_SIDED|95.0|64.3|106.6|||ANOVA|||||106.6|64.3|<.0001
74004140|NCT03373201|147557316|SUPERIORITY||Difference between LS means|-15.1|||<|0.0001|TWO_SIDED|95.0|-26.2|-4.0|||ANOVA|||||-4.0|-26.2|<.0001
74004141|NCT03373201|147557317|SUPERIORITY||Difference between LS means|-74.6|||<|0.0001|TWO_SIDED|95.0|-94.8|-54.3|||ANOVA|||||-54.3|-94.8|<.0001
74004142|NCT03373201|147557318|SUPERIORITY||Difference between LS Means.|-0.5||||0.0083|TWO_SIDED|95.0|-0.9|-0.1|||ANOVA|||||-0.1|-0.9|0.0083
74004143|NCT03373201|147557319|SUPERIORITY||Difference between LS Means.|6.6||||0.0099|TWO_SIDED|95.0|1.6|11.6|||ANOVA|||||11.6|1.6|0.0099
74004144|NCT01215422|147557342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||>|0.05|ONE_SIDED|95.0|0.15||||Regression, Logistic||||||0.15|>0.05
74004145|NCT01215422|147557343|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The p-value represents the comparison of the two interventions combined and compared against baseline for Grades III and IV summed together.|Fisher Exact|||||||0.03
74004146|NCT01215422|147557346|SUPERIORITY_OR_OTHER||R-squared|0.16|||>|0.05||95.0||||Correlation between years of experience (all anesthesiologists, pooled) and time to intubation (both GS and KS VLSs, pooled)|Correlation|||||||>0.05
74004147|NCT02113241|147557483|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
74004148|NCT02113241|147557483|SUPERIORITY|||||||0.089||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.089
74004149|NCT02113241|147557484|SUPERIORITY|||||||0.003||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.003
74004150|NCT02113241|147557484|SUPERIORITY|||||||0.248||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.248
74004151|NCT02113241|147557485|SUPERIORITY|||||||0.161||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.161
74004152|NCT02113241|147557485|SUPERIORITY|||||||0.079||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.079
74004153|NCT02113241|147557486|SUPERIORITY|||||||0.067||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.067
74004154|NCT02113241|147557486|SUPERIORITY|||||||0.918||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.918
74004155|NCT02113241|147557487|SUPERIORITY|||||||0.128||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.128
74004156|NCT02113241|147557487|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.454
74004157|NCT02113241|147557488|SUPERIORITY|||||||0.433|||||||Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.433
74004158|NCT02113241|147557488|SUPERIORITY|||||||0.407||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.407
74004159|NCT02113241|147557489|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
74004160|NCT02113241|147557489|SUPERIORITY|||||||0.826||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.826
74004161|NCT02113241|147557490|SUPERIORITY|||||||0.791||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.791
74004162|NCT02113241|147557490|SUPERIORITY|||||||0.413||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.413
74004163|NCT02113241|147557491|SUPERIORITY|||||||0.075||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.075
74004164|NCT02113241|147557491|SUPERIORITY|||||||0.432||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.432
74004165|NCT02113241|147557492|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
74004166|NCT02113241|147557492|SUPERIORITY|||||||0.835||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.835
74004167|NCT02113241|147557493|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
74004168|NCT02113241|147557493|SUPERIORITY|||||||0.778||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.778
74004169|NCT02113241|147557494|SUPERIORITY|||||||0.338||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.338
74004170|NCT02113241|147557494|SUPERIORITY|||||||0.309||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.309
74004171|NCT02113241|147557495|SUPERIORITY|||||||0.049||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.049
74004172|NCT02113241|147557495|SUPERIORITY|||||||0.563||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.563
74004173|NCT02113241|147557496|SUPERIORITY|||||||0.85||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.850
74004174|NCT02113241|147557496|SUPERIORITY|||||||0.206||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.206
74004175|NCT02113241|147557497|SUPERIORITY|||||||0.006||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.006
74004176|NCT02113241|147557497|SUPERIORITY|||||||0.95||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.950
74004177|NCT02113241|147557498|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.011
74004178|NCT02113241|147557498|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.454
74004179|NCT02113241|147557499|SUPERIORITY|||||||0.652||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.652
74004180|NCT02113241|147557499|SUPERIORITY|||||||0.055||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.055
74004181|NCT02113241|147557500|SUPERIORITY|||||||0.254||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.254
74004182|NCT02113241|147557500|SUPERIORITY|||||||0.787||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.787
74004183|NCT02113241|147557501|SUPERIORITY|||||||0.129||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.129
74004184|NCT02113241|147557501|SUPERIORITY|||||||0.365||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.365
74004185|NCT02113241|147557502|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
74004186|NCT02113241|147557502|SUPERIORITY|||||||0.175||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.175
74004187|NCT02113241|147557503|SUPERIORITY|||||||0.392||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.392
74004188|NCT02113241|147557503|SUPERIORITY|||||||0.123|||||||Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.123
74004189|NCT02113241|147557504|SUPERIORITY|||||||0.176||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.176
74004190|NCT02113241|147557504|SUPERIORITY|||||||0.268||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.268
74004191|NCT02113241|147557505|SUPERIORITY|||||||0.064||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.064
73878135|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|6.78||||0.048|TWO_SIDED|95.0|0.07|13.48|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.48|0.07|0.048
74004192|NCT02113241|147557505|SUPERIORITY|||||||0.462||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.462
74038114|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.6276||95.0|-0.68|0.42||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Heavy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.42|-0.68|0.6276
74038115|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.0917||95.0|-1.23|0.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Overall unpleasantness: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.09|-1.23|0.0917
74038116|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2089||95.0|-1.13|0.25||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.25|-1.13|0.2089
74038117|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4188||95.0|-0.75|0.31||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.31|-0.75|0.4188
74038118|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.6959||95.0|-0.32|0.21||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.21|-0.32|0.6959
74038119|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.4806||95.0|-0.64|0.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.30|-0.64|0.4806
74004193|NCT02113241|147557506|SUPERIORITY|||||||0.346||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.346
74004194|NCT02113241|147557506|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.002
74004195|NCT02901041|147557508|SUPERIORITY||Mean Difference (Net)|0.02||||0.98|TWO_SIDED|95.0|-1.41|1.45|||t-test, 2 sided|t=0.03, df=79.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||1.45|-1.41|.98
74004196|NCT02901041|147557509|SUPERIORITY||Mean Difference (Net)|-0.83||||0.13|TWO_SIDED|95.0|-1.92|0.26|||t-test, 2 sided|t=-1.52, df=56.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.26|-1.92|.13
74038120|NCT00589979|147629585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.2291||95.0|-0.74|0.18||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average paroxysmal pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.18|-0.74|0.2291
74039840|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.2||0.4823|TWO_SIDED|95.0|-0.53|0.25|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.25|-0.53|0.4823
74039841|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.2754|TWO_SIDED|95.0|-0.6|0.17|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.60|0.2754
74039842|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5861|TWO_SIDED|95.0|-0.5|0.29|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.29|-0.50|0.5861
74039843|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2||0.4346|TWO_SIDED|95.0|-0.54|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.54|0.4346
74039844|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.2||0.8752|TWO_SIDED|95.0|-0.42|0.36|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.36|-0.42|0.8752
74039845|NCT02528253|147632455|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.2||0.2663|TWO_SIDED|95.0|-0.6|0.17|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.60|0.2663
74039846|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0013|TWO_SIDED|95.0|-0.77|-0.19|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.19|-0.77|0.0013
74039847|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.15||0.0001|TWO_SIDED|95.0|-0.87|-0.28|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-0.87|0.0001
74039848|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2272|TWO_SIDED|95.0|-0.43|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.43|0.2272
74039849|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.0209|TWO_SIDED|95.0|-0.58|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.58|0.0209
74039850|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.14||0.0029|TWO_SIDED|95.0|-0.67|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.14|-0.67|0.0029
74039851|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.92|-0.28|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-0.92|0.0002
74039852|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.1|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.46|-1.10|<.0001
73878136|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|6.65||||0.053|TWO_SIDED|95.0|-0.09|13.4|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.40|-0.09|0.053
74038121|NCT00589979|147629586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.3185||95.0|0.77|2.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||2.27|0.77|0.3185
74038122|NCT00589979|147629587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4748||95.0|0.72|2.06||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||2.06|0.72|0.4748
74038123|NCT00589979|147629588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.7839||95.0|-0.74|0.98||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.98|-0.74|0.7839
74038124|NCT00589979|147629590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.3773||95.0|-0.02|0.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.04|-0.02|0.3773
74038125|NCT00589979|147629591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.2605||95.0|0.38|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||1.30|0.38|0.2605
74038126|NCT00589979|147629592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3193||95.0|0.44|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||1.30|0.44|0.3193
74038127|NCT00589979|147629593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.74||||0.1378||95.0|-0.57|4.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates||4.04|-0.57|0.1378
74038128|NCT00589979|147629594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.6833||95.0|0.47|1.65||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Logistic|An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|||1.65|0.47|0.6833
74038129|NCT00589979|147629595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.16||||0.1143||95.0|-5.48|49.8||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Disturbance: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||49.8|-5.48|0.1143
74039853|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1198|TWO_SIDED|95.0|-0.53|0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.53|0.1198
73878137|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|9.29||||0.007|TWO_SIDED|95.0|2.55|16.04|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||16.04|2.55|0.007
73878138|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|4.61||||0.191|TWO_SIDED|95.0|-2.31|11.53|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.53|-2.31|0.191
73878139|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.747|TWO_SIDED|95.0|-7.8|5.6|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.60|-7.80|0.747
74004197|NCT02901041|147557510|SUPERIORITY||Mean Difference (Net)|-0.07||||0.19|TWO_SIDED|95.0|-0.17|0.03||Equality of variance was not assumed.|t-test, 2 sided|t=-1.33, df=72.65||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.03|-0.17|.19
74004198|NCT02901041|147557511|SUPERIORITY||Mean Difference (Net)|-0.17||||0.05|TWO_SIDED|95.0|-0.34|0.0|||t-test, 2 sided|t=-1.99, df=56.00||||0.00|-0.34|.05
74004199|NCT02901041|147557512|SUPERIORITY||Mean Difference (Net)|0.03||||0.71|TWO_SIDED|95.0|-0.11|0.17|||t-test, 2 sided|t=0.37,df=79.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.17|-0.11|.71
74004200|NCT02901041|147557513|SUPERIORITY||Mean Difference (Net)|-0.11||||0.12|TWO_SIDED|95.0|-0.26|0.03|||t-test, 2 sided|t=-1.59,df=56.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.03|-0.26|.12
74004201|NCT02901041|147557514|SUPERIORITY||Mean Difference (Net)|0.14||||0.98|TWO_SIDED|95.0|-9.89|10.18|||t-test, 2 sided|t=0.03, df=79.00||||10.18|-9.89|.98
74004202|NCT02901041|147557515|SUPERIORITY||Mean Difference (Net)|-5.8||||0.13|TWO_SIDED|95.0|-13.43|1.83|||t-test, 2 sided|t=-1.52, df=56.00||||1.83|-13.43|.13
74004203|NCT02901041|147557516|SUPERIORITY||Mean Difference (Net)|27.07||||0.75|TWO_SIDED|95.0|-144.06|198.2|||t-test, 2 sided|t=0.32,df=61.00||||198.20|-144.06|.75
74004204|NCT02901041|147557517|SUPERIORITY||Mean Difference (Net)|99.05||||0.35|TWO_SIDED|95.0|-111.11|309.21|||t-test, 2 sided|t=0.95, df=46.00||||309.21|-111.11|.35
74004205|NCT02901041|147557518|SUPERIORITY||Mean Difference (Net)|0.85||||0.51|TWO_SIDED|95.0|-1.69|3.4|||t-test, 2 sided|t=0.67, df=58.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||3.40|-1.69|.51
74004206|NCT02901041|147557519|SUPERIORITY||Mean Difference (Net)|-0.42||||0.55|TWO_SIDED|95.0|-1.82|0.98|||t-test, 2 sided|t=-0.61,df=36||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.98|-1.82|.55
74004207|NCT02901041|147557520|SUPERIORITY||Mean Difference (Net)|0.15||||0.95|TWO_SIDED|95.0|-4.15|4.45|||t-test, 2 sided|t=0.07,df=58.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||4.45|-4.15|.95
74004208|NCT02901041|147557521|SUPERIORITY||Mean Difference (Net)|3.34||||0.42|TWO_SIDED|95.0|-4.93|11.62|||t-test, 2 sided|t=0.82, df=38.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||11.62|-4.93|.42
74004209|NCT02901041|147557522|SUPERIORITY||Mean Difference (Net)|0.32||||0.17|TWO_SIDED|95.0|-0.15|0.8||Equal variance was not assumed.|t-test, 2 sided|t=1.39, df=36.37||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.80|-0.15|.17
74004210|NCT02901041|147557523|SUPERIORITY||Mean Difference (Net)|0.41||||0.14|TWO_SIDED|95.0|-0.14|0.97||Equal variances were not assumed when conducting the t-test.|t-test, 2 sided|t=1.53, df=24.05||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.97|-0.14|0.14
74004211|NCT02901041|147557524|SUPERIORITY||Mean Difference (Net)|3.07||||0.14|TWO_SIDED|95.0|-1.03|7.16||Equal variances were not assumed when conducting the t-tests.|t-test, 2 sided|t=1.51,df=39.34||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||7.16|-1.03|.14
74004212|NCT02901041|147557525|SUPERIORITY||Mean Difference (Net)|3.18||||0.4|TWO_SIDED|95.0|-4.39|10.75||Equality of variance was not assumed.|t-test, 2 sided|t=0.85, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||10.75|-4.39|.40
74004213|NCT02901041|147557526|SUPERIORITY||Mean Difference (Net)|0.4||||0.06|TWO_SIDED|95.0|-0.01|0.81||Equal variances were not assumed when conducting the t-test.|t-test, 2 sided|t=1.97, df=38.37||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.81|-0.01|.06
74004214|NCT02901041|147557527|SUPERIORITY||Mean Difference (Net)|0.03||||0.96|TWO_SIDED|95.0|-1.0|1.05|||t-test, 2 sided|t=.06, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||1.05|-1.00|.96
74004215|NCT02901041|147557528|SUPERIORITY||Mean Difference (Net)|2.03||||0.6|TWO_SIDED|95.0|-5.58|9.64|||t-test, 2 sided|t=0.53,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||9.64|-5.58|.60
74004216|NCT02901041|147557529|SUPERIORITY||Mean Difference (Net)|-0.06||||0.21|TWO_SIDED|95.0|-0.15|0.03|||t-test, 2 sided|t=-1.27, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.03|-0.15|.21
74004217|NCT02901041|147557530|SUPERIORITY||Mean Difference (Net)|-0.28||||0.09|TWO_SIDED|95.0|-0.6|0.04|||t-test, 2 sided|t=-1.74,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.04|-0.60|.09
73878140|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|-1.23||||0.72|TWO_SIDED|95.0|-7.96|5.5|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.50|-7.96|0.720
73878141|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|1.41||||0.68|TWO_SIDED|95.0|-5.31|8.14|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||8.14|-5.31|0.680
73878142|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.971|TWO_SIDED|95.0|-6.82|6.57|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.57|-6.82|0.971
73878143|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|2.52||||0.46|TWO_SIDED|95.0|-4.17|9.21|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.21|-4.17|0.460
73878144|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|2.64||||0.441|TWO_SIDED|95.0|-4.09|9.37|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.37|-4.09|0.441
73878145|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|6.76||||0.07|TWO_SIDED|95.0|-0.55|14.08|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.08|-0.55|0.070
73878146|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|8.44||||0.023|TWO_SIDED|95.0|1.16|15.72|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||15.72|1.16|0.023
74004218|NCT02901041|147557531|SUPERIORITY||Mean Difference (Net)|-0.35||||0.1|TWO_SIDED|95.0|-0.78|0.07|||t-test, 2 sided|t=-1.69, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.07|-0.78|.10
73878147|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|6.96||||0.064|TWO_SIDED|95.0|-0.4|14.31|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.31|-0.40|0.064
73878148|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|11.08||||0.003|TWO_SIDED|95.0|3.79|18.38|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||18.38|3.79|0.003
73878149|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.274|TWO_SIDED|95.0|-3.32|11.72|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.72|-3.32|0.274
73878150|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.649|TWO_SIDED|95.0|-5.57|8.93|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||8.93|-5.57|0.649
74004219|NCT02901041|147557532|SUPERIORITY||Mean Difference (Net)|0.02||||0.8|TWO_SIDED|95.0|-0.15|0.19|||t-test, 2 sided|t=0.25,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.19|-0.15|0.80
74004220|NCT02901041|147557533|SUPERIORITY||Mean Difference (Net)|-5.61||||0.41|TWO_SIDED|95.0|-14.56|3.34|||t-test, 2 sided|t=-0.84,df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||3.34|-14.56|.41
73878151|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.958|TWO_SIDED|95.0|-7.12|7.51|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||7.51|-7.12|0.958
74038130|NCT00589979|147629595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.9108||95.0|-19.8|22.2||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Effectiveness: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||22.2|-19.8|0.9108
74004221|NCT03249714|147557541|SUPERIORITY||Rate ratio|0.064|||<|0.001|TWO_SIDED|95.0|0.018|0.232|||negative binominal regression model|||||0.232|0.018|<0.001
74004222|NCT03249714|147557542|SUPERIORITY||rate ratio|0.136||||0.003|TWO_SIDED|95.0|0.036|0.513||Statistical significance (2-sided) at the 0.05 level|negative binomial regression|||||0.513|0.036|0.003
74038131|NCT00589979|147629595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.31||||0.3769||95.0|-10.3|27.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Supplementation: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||27.0|-10.3|0.3769
74038132|NCT02180217|147629611|OTHER||Odds Ratio (OR)|13.71|||<|0.001|TWO_SIDED|95.0|3.73|53.44|||Cochran-Mantel-Haenszel|||||53.44|3.73|<.001
74004223|NCT03249714|147557542|SUPERIORITY||rate ratio|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||negative binominal regression|Indicates statistical significance (2-sided) at the 0.05 level.||||0.000|0.000|< 0.001
74038133|NCT00738374|147629638|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Chi-squared|||Analysis compared responders and non-responders.||||0.0008
74038134|NCT00738374|147629639|SUPERIORITY_OR_OTHER|||||||0.0795|TWO_SIDED||||||Chi-squared|||||||0.0795
74038135|NCT00738374|147629655|SUPERIORITY_OR_OTHER|||||||0.2712|TWO_SIDED||||||Log Rank|||||||0.2712
74038136|NCT03334396|147629658|SUPERIORITY||Odds Ratio (OR)|2.61||||0.02|TWO_SIDED|95.0|1.17|5.84|||Regression, Logistic|||||5.84|1.17|0.020
74038137|NCT03334396|147629658|SUPERIORITY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|1.93|8.7|||Regression, Logistic|||||8.70|1.93|<0.001
74091008|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.59|STANDARD_ERROR_OF_MEAN|3.125|||TWO_SIDED|95.0|-8.8|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-8.8|
74004224|NCT03249714|147557543|SUPERIORITY||Rate ratio|0.284||||0.002|TWO_SIDED|95.0|0.13|0.62|||negative binominal regression|||||0.620|0.130|0.002
74004225|NCT03249714|147557544|SUPERIORITY||Rate ratio|0.42||||0.119|TWO_SIDED|95.0|0.141|1.25|||negative binominal regression|||||1.250|0.141|0.119
74038138|NCT03334396|147629659|SUPERIORITY||Odds Ratio (OR)|2.72||||0.014|TWO_SIDED|95.0|1.23|6.01|||Regression, Logistic|||||6.01|1.23|0.014
74038139|NCT03334396|147629660|SUPERIORITY||Odds Ratio (OR)|2.03||||0.032|TWO_SIDED|95.0|1.06|3.88|||Regression, Logistic|||||3.88|1.06|0.032
74091009|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.84|STANDARD_ERROR_OF_MEAN|3.7013|||TWO_SIDED|95.0|-11.2|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.5|-11.2|
74038140|NCT03334396|147629660|SUPERIORITY||Odds Ratio (OR)|2.46||||0.006|TWO_SIDED|95.0|1.29|4.67|||Regression, Logistic|||||4.67|1.29|0.006
74004226|NCT01996813|147557553|SUPERIORITY||Odds Ratio (OR)|0.115||||0.0553|TWO_SIDED|95.0|0.002|1.034||The exact p-value was estimated|Regression, Logistic|The method was exact logistic regression||The null hypothesis is that there is no difference in the odds of a cerebral desaturation event between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position||1.034|0.002|.0553
74038141|NCT03334396|147629660|SUPERIORITY||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|2.01|6.89|||Regression, Logistic|||||6.89|2.01|<0.001
74038142|NCT03334396|147629661|SUPERIORITY||Odds Ratio (OR)|1.73||||0.21|TWO_SIDED|95.0|0.74|4.05|||Regression, Logistic|||||4.05|0.74|0.210
74038143|NCT03334396|147629661|SUPERIORITY||Odds Ratio (OR)|2.5||||0.029|TWO_SIDED|95.0|1.1|5.7|||Regression, Logistic|||||5.70|1.10|0.029
74038144|NCT03334396|147629661|SUPERIORITY||Odds Ratio (OR)|4.13|||<|0.001|TWO_SIDED|95.0|1.91|8.91|||Regression, Logistic|||||8.91|1.91|<0.001
74038145|NCT03334396|147629662|SUPERIORITY||Mean Difference (Final Values)|-13.4|STANDARD_ERROR_OF_MEAN|5.78||0.021|TWO_SIDED|95.0|-24.77|-2.03|||Mixed Models Analysis|||||-2.03|-24.77|0.021
74038146|NCT03334396|147629662|SUPERIORITY||Mean Difference (Final Values)|-17.07|STANDARD_ERROR_OF_MEAN|5.57||0.002|TWO_SIDED|95.0|-28.05|-6.1|||Mixed Models Analysis|||||-6.10|-28.05|0.002
74038147|NCT03334396|147629662|SUPERIORITY||Mean Difference (Final Values)|-24.54|STANDARD_ERROR_OF_MEAN|5.23|<|0.001|TWO_SIDED|95.0|-34.84|-14.24|||Mixed Models Analysis|||||-14.24|-34.84|<0.001
74038148|NCT03334396|147629663|SUPERIORITY||Odds Ratio (OR)|4.28||||0.025|TWO_SIDED|95.0|1.2|15.24|||Regression, Logistic|||||15.24|1.20|0.025
74038149|NCT03334396|147629663|SUPERIORITY||Odds Ratio (OR)|6.14||||0.004|TWO_SIDED|95.0|1.79|20.99|||Regression, Logistic|||||20.99|1.79|0.004
74038150|NCT03334396|147629663|SUPERIORITY||Odds Ratio (OR)|8.76|||<|0.001|TWO_SIDED|95.0|2.68|28.58|||Regression, Logistic|||||28.58|2.68|<0.001
74038151|NCT03334396|147629664|SUPERIORITY||Odds Ratio (OR)|1.6||||0.246|TWO_SIDED|95.0|0.72|3.56|||Regression, Logistic|||||3.56|0.72|0.246
74038152|NCT03334396|147629664|SUPERIORITY||Odds Ratio (OR)|1.73||||0.169|TWO_SIDED|95.0|0.79|3.77|||Regression, Logistic|||||3.77|0.79|0.169
74038153|NCT03334396|147629664|SUPERIORITY||Odds Ratio (OR)|3.62|||<|0.001|TWO_SIDED|95.0|1.82|7.18|||Regression, Logistic|||||7.18|1.82|<0.001
74038154|NCT03334396|147629665|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.103|TWO_SIDED|95.0|-0.82|0.08|||Mixed Models Analysis|||||0.08|-0.82|0.103
73878152|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|4.32||||0.242|TWO_SIDED|95.0|-2.93|11.58|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.58|-2.93|0.242
73878153|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.69|TWO_SIDED|95.0|-8.77|5.81|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.81|-8.77|0.690
73878154|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|2.64||||0.473|TWO_SIDED|95.0|-4.58|9.87|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.87|-4.58|0.473
73878155|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|4.13||||0.267|TWO_SIDED|95.0|-3.17|11.43|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.43|-3.17|0.267
74004227|NCT01996813|147557554|SUPERIORITY||Mean Difference (Final Values)|40.31|||<|0.001|TWO_SIDED|95.0|20.22|60.39|||t-test, 2 sided|A Satterthwaite correction was used to adjust the degrees of freedom||The null hypothesis is that there is no difference in the average length of surgery between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position||60.39|20.22|<.001
74004228|NCT01942720|147557568|SUPERIORITY_OR_OTHER||Sperman correlation coeficient|-0.7||||0.631|TWO_SIDED||||||Sperman test|||Relationship of total PillCam SB Lewis score with PGA score change from baseline visit to 6 month follow-up||||0.631
74004229|NCT01942720|147557568|SUPERIORITY_OR_OTHER||Sperman correlation coeficient|0.022||||0.882|TWO_SIDED||||||Sperman correlation|||Relationship of total PillCam SB CECDEIS score with PGA score change from baseline visit to 6 month follow-up||||0.882
74004230|NCT01942720|147557569|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.735|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB TI Lewis scores with TI SES-CD score at baseline visit||||<0.001
74004231|NCT01942720|147557569|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.726|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB TI CECDEIS scores with TI SES-CD score at baseline visit||||<0.001
74004232|NCT01942720|147557570|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.493||||0.002|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB Lewis score with TI SES-CD score change from baseline visit to 6 month follow-up||||0.002
74038155|NCT03334396|147629665|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.352|TWO_SIDED|95.0|-0.65|0.23|||Mixed Models Analysis|||||0.23|-0.65|0.352
73878156|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|7.32||||0.032|TWO_SIDED|95.0|0.65|13.99|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.99|0.65|0.032
73878157|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|7.61||||0.025|TWO_SIDED|95.0|0.97|14.24|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.24|0.97|0.025
73878158|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.046|TWO_SIDED|95.0|0.12|13.49|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.49|0.12|0.046
74004233|NCT01942720|147557570|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.531|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB CECDEIS score with TI SES-CD score change from baseline visit to 6 month follow-up||||<0.001
74038156|NCT03334396|147629665|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.006|TWO_SIDED|95.0|-1.0|-0.17|||Mixed Models Analysis|||||-0.17|-1.00|0.006
74004234|NCT01942720|147557571|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.752|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam total SB Lewis score change with TI Leis score change from baseline visit to 6 month follow-up||||<0.001
74004235|NCT01942720|147557571|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.785|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam total SB CECDEIS score change with TI Leis score change from baseline visit to 6 month follow-up||||<0.001
74038157|NCT03334396|147629666|SUPERIORITY||Mean Difference (Final Values)|-1.08||||0.005|TWO_SIDED|95.0|-1.84|-0.32|||Mixed Models Analysis|||||-0.32|-1.84|0.005
73878159|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|10.19||||0.003|TWO_SIDED|95.0|3.52|16.85|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||16.85|3.52|0.003
74004236|NCT03952806|147557580|SUPERIORITY||Least Square mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.4656|TWO_SIDED|95.0|-0.6|1.3|||Mixed Models Analysis|||||1.30|-0.60|0.4656
74038158|NCT03334396|147629666|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.051|TWO_SIDED|95.0|-1.48|0.0|||Mixed Models Analysis|||||0.00|-1.48|0.051
74038159|NCT03334396|147629666|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.002|TWO_SIDED|95.0|-1.79|-0.39|||Mixed Models Analysis|||||-0.39|-1.79|0.002
74038160|NCT03334396|147629667|SUPERIORITY||Odds Ratio (OR)|1.9||||0.019|TWO_SIDED|95.0|1.11|3.25|||Regression, Logistic|||||3.25|1.11|0.019
74038161|NCT03334396|147629667|SUPERIORITY||Mean Difference (Final Values)|2.44|||<|0.001|TWO_SIDED|95.0|1.44|4.14|||Regression, Logistic|||||4.14|1.44|<0.001
74038162|NCT03334396|147629667|SUPERIORITY||Mean Difference (Final Values)|4.18|||<|0.001|TWO_SIDED|95.0|2.51|6.96|||Regression, Logistic|||||6.96|2.51|<0.001
74038163|NCT03334396|147629668|SUPERIORITY||Odds Ratio (OR)|1.98||||0.424|TWO_SIDED|95.0|0.37|10.63|||Regression, Logistic|||||10.63|0.37|0.424
73878160|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.207|TWO_SIDED|95.0|-2.45|11.25|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.25|-2.45|0.207
73878161|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.932|TWO_SIDED|95.0|-6.33|6.91|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.91|-6.33|0.932
73878162|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.879|TWO_SIDED|95.0|-7.17|6.14|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.14|-7.17|0.879
73878163|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.396|TWO_SIDED|95.0|-3.77|9.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.50|-3.77|0.396
73878164|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.812|TWO_SIDED|95.0|-7.44|5.83|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.83|-7.44|0.812
73878165|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.444|TWO_SIDED|95.0|-4.03|9.19|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.19|-4.03|0.444
73878166|NCT03084796|147295454|SUPERIORITY||Mean Difference (Final Values)|3.38||||0.319|TWO_SIDED|95.0|-3.27|10.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||10.04|-3.27|0.319
73878167|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.43|||<|0.001|TWO_SIDED|95.0|-0.67|-0.18|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model repeated for measurements (MMRM), including treatment, inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||-0.18|-0.67|<0.001
74004237|NCT00655863|147557591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-307.229|||<|0.001|TWO_SIDED|95.0|-443.168|-171.29||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD and placebo groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curver for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.||-171.290|-443.168|<0.001
74038164|NCT03334396|147629668|SUPERIORITY||Odds Ratio (OR)|2.89||||0.182|TWO_SIDED|95.0|0.61|13.75|||Regression, Logistic|||||13.75|0.61|0.182
73878168|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.023|TWO_SIDED|95.0|-0.53|-0.04|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.04|-0.53|0.023
73878169|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.067|TWO_SIDED|95.0|-0.47|0.02|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.02|-0.47|0.067
73878170|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.66|-0.17|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.17|-0.66|<0.001
73878171|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.084|TWO_SIDED|95.0|-0.47|0.03|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.03|-0.47|0.084
73878172|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.243|TWO_SIDED|95.0|-0.1|0.39|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.39|-0.10|0.243
73878173|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.112|TWO_SIDED|95.0|-0.05|0.44|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.44|-0.05|0.112
74038165|NCT03334396|147629668|SUPERIORITY||Odds Ratio (OR)|1.94||||0.441|TWO_SIDED|95.0|0.36|10.41|||Regression, Logistic|||||10.41|0.36|0.441
74038166|NCT03334396|147629669|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|3.17||0.093|TWO_SIDED|95.0|-11.57|0.9|||Mixed Models Analysis|||||0.90|-11.57|0.093
73878174|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.929|TWO_SIDED|95.0|-0.23|0.26|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.26|-0.23|0.929
73878175|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.668|TWO_SIDED|95.0|-0.19|0.3|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.30|-0.19|0.668
74004238|NCT00655863|147557591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-253.711|||<|0.001||95.0|-394.161|-113.262||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD + Pioglitazone 30 mg QD and placebo QD groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curve for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.||-113.262|-394.161|<0.001
74004239|NCT01138007|147557609|SUPERIORITY_OR_OTHER||Least Squared Mean Difference|-0.5||||0.853|TWO_SIDED|95.0|-2.7|1.7||The p-value was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates. The multiplicity was adjusted by Dunnett's step-down procedure.|ANCOVA||The confidence interval was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.|||1.7|-2.7|0.853
74004240|NCT01138007|147557609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.0||||95.0|||||||In the analysis plan, the second comparison of interest was not to be performed if the first comparison failed to show statistical significance.|||||
73878176|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.281|TWO_SIDED|95.0|-0.38|0.11|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.11|-0.38|0.281
73878177|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.134|TWO_SIDED|95.0|-0.43|0.06|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.06|-0.43|0.134
74004241|NCT00744523|147557685|SUPERIORITY_OR_OTHER||proportion of the primary endpoint|2.7|STANDARD_ERROR_OF_MEAN|5.0|<|0.05|ONE_SIDED|95.0||5.2|||t-test, 1 sided||"Parameter Dispersion Type of Standard Error of the mean is meant to state that 'mean is the mean of proportions in the sense of a central-limit theorem"|The ARMOUR trial tested the null hypothesis that the MACCE rate was greater than or equal to the Performance Goal (PG) of 13% versus the alternative hypothesis that the true MACCE rate was less than the PG. The sample size was calculated based on 90% power and a Type I error rate of 0.05 (one-sided). The Performance Goal was calculated from results of carotid artery stenting trials that utilized embolic protection devices (EPD).||5.2||<0.05
74004242|NCT00325039|147557722|NON_INFERIORITY_OR_EQUIVALENCE|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success rate (RMUS-TMUS)|3.0|||||TWO_SIDED|95.0|-3.6|9.6||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.||9.6|-3.6|
74004243|NCT00325039|147557723|SUPERIORITY_OR_OTHER||Difference in proportions|-4.1||||0.14||95.0||||This was not adjusted for multiple comparisons; the a priori threshold for statistical significance was 0.05.|Chi-squared|||Although the primary aim of the study was designed as an equivalence trial, the secondary aims were considered as superiority tests.||||0.14
74038167|NCT03334396|147629669|SUPERIORITY||Mean Difference (Final Values)|-7.97|STANDARD_ERROR_OF_MEAN|3.07||0.01|TWO_SIDED|95.0|-14.01|-1.92|||Mixed Models Analysis|||||-1.92|-14.01|0.010
74038168|NCT03334396|147629669|SUPERIORITY||Mean Difference (Final Values)|-14.79|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-20.46|-9.13|||Mixed Models Analysis|||||-9.13|-20.46|<0.001
74038169|NCT03334396|147629670|SUPERIORITY||Odds Ratio (OR)|1.17||||0.874|TWO_SIDED|95.0|0.17|7.77|||Regression, Logistic|||||7.77|0.17|0.874
74004244|NCT00325039|147557724|NON_INFERIORITY_OR_EQUIVALENCE|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success (RMUS - TMUS)|6.4|||||TWO_SIDED|95.0|-1.6|14.3||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.||14.3|-1.6|
74038170|NCT03334396|147629670|SUPERIORITY||Odds Ratio (OR)|2.88||||0.176|TWO_SIDED|95.0|0.62|13.36|||Regression, Logistic|||||13.36|0.62|0.176
74038171|NCT03334396|147629670|SUPERIORITY||Odds Ratio (OR)|2.72||||0.201|TWO_SIDED|95.0|0.59|12.65|||Regression, Logistic|||||12.65|0.59|0.201
74038172|NCT03334396|147629671|SUPERIORITY||Mean Difference (Final Values)|-5.99|STANDARD_ERROR_OF_MEAN|2.88||0.039|TWO_SIDED|95.0|-11.67|-0.31|||Mixed Models Analysis|||||-0.31|-11.67|0.039
74038173|NCT03334396|147629671|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.8||0.058|TWO_SIDED|95.0|-10.86|0.18|||Mixed Models Analysis|||||0.18|-10.86|0.058
73878178|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.003|TWO_SIDED|95.0|-0.7|-0.14|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.14|-0.70|0.003
73878179|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.02|TWO_SIDED|95.0|-0.61|-0.05|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.05|-0.61|0.020
73878180|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.017|TWO_SIDED|95.0|-0.62|-0.06|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.06|-0.62|0.017
73878181|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.8|-0.24|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.24|-0.80|<0.001
74004245|NCT00325039|147557725|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||The null hypothesis is that the two arms do not differ according to quality of life, as measured by the IIQ.||||0.47
74004246|NCT00325039|147557726|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||The UDI measure was compared using a two-sample t test.||||0.41
74004247|NCT00892723|147557734|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.87
74004248|NCT00892723|147557734|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.86
74004249|NCT00892723|147557734|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.11
74004250|NCT00892723|147557734|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.91
74004251|NCT00892723|147557735|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.23
74004252|NCT00892723|147557735|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.82
74004253|NCT00892723|147557735|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.23
74004254|NCT00892723|147557735|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.71
74004255|NCT00892723|147557736|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.73
74004256|NCT00892723|147557736|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.94
74004257|NCT00892723|147557736|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.14
74004258|NCT00892723|147557736|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.68
74004259|NCT00892723|147557736|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.56
74004260|NCT00892723|147557736|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.32
74004261|NCT00892723|147557736|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.33
74004262|NCT00892723|147557736|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.65
74004263|NCT00892723|147557736|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.21
74004264|NCT00892723|147557736|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.90
74004265|NCT00892723|147557737|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.||||||0.16
74004266|NCT00892723|147557737|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.74
74004267|NCT00892723|147557737|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|95.0||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)|||||||0.45
74004268|NCT00892723|147557737|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.079
74004269|NCT00892723|147557737|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.16
74004270|NCT00892723|147557737|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|95.0||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.45
74004271|NCT00426153|147557738|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Rank-sum test|||P values \<0.05 were considered statistically significant.||||0.048
74004272|NCT00426153|147557739|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P values \< 0.05 were considered statistically significant|Rank sum|||||||0.045
74004273|NCT00426153|147557740|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P Values \< 0.05 were considered statistically significant|Rank sum|||||||0.98
74004274|NCT00150969|147557742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
74004275|NCT00150969|147557749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
74004276|NCT01313689|147557769|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.2677|TWO_SIDED|95.0|0.5|1.24|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.24|0.50|0.2677
74004277|NCT01313689|147557769|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0837|TWO_SIDED|95.0|0.19|1.53|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.53|0.19|0.0837
74004278|NCT01313689|147557770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.003|TWO_SIDED|95.0|0.35|0.87|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum.|||0.87|0.35|0.0030
74004279|NCT01313689|147557770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.0262|TWO_SIDED|95.0|0.21|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.17|0.21|0.0262
74004280|NCT01313689|147557771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.942||||0.0223|TWO_SIDED|95.0|1.166|7.424|||Regression, Logistic|conditional logistic regression with interval and pooled stratum||||7.424|1.166|0.0223
74004281|NCT01313689|147557771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|999.999||||0.9985|TWO_SIDED|95.0|0.001|999.999|||Regression, Logistic|conditional logistic regression with interval and pooled stratum||||999.999|0.001|0.9985
74004282|NCT01313689|147557772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.366||||0.4159|TWO_SIDED|95.0|0.644|2.899||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum included in the Strata statement|Regression, Logistic|||||2.899|0.644|0.4159
74038174|NCT03334396|147629671|SUPERIORITY||Mean Difference (Final Values)|-11.16|STANDARD_DEVIATION|2.63|<|0.001|TWO_SIDED|95.0|-16.33|-5.98|||Mixed Models Analysis|||||-5.98|-16.33|<0.001
74038175|NCT03334396|147629672|SUPERIORITY|||||||0.067|||||||Fisher Exact|||||||0.067
74004283|NCT01313689|147557772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.225||||0.8866|TWO_SIDED|95.0|0.076|19.862||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum in the strata statement|Regression, Logistic|||||19.862|0.076|0.8866
74004284|NCT01313689|147557773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.1732|TWO_SIDED|95.0|0.48|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.17|0.48|0.1732
74038176|NCT03334396|147629672|SUPERIORITY|||||||0.799|||||||Fisher Exact|||||||0.799
74038177|NCT03334396|147629672|SUPERIORITY|||||||0.782|||||||Fisher Exact|||||||0.782
74038178|NCT03334396|147629673|SUPERIORITY||Mean Difference (Final Values)|-19.25|STANDARD_ERROR_OF_MEAN|7.33||0.009|TWO_SIDED|95.0|-33.69|-4.81|||Mixed Models Analysis|||||-4.81|-33.69|0.009
74004285|NCT01313689|147557773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.8128|TWO_SIDED|95.0|0.46|2.68||P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Log Rank||Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||2.68|0.46|0.8128
74004286|NCT01519466|147557870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_DEVIATION|2.32||0.0926|TWO_SIDED|95.0|-1.55|0.12|||t-test, 2 sided|||||0.12|-1.55|0.0926
74004287|NCT01519466|147557870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|STANDARD_DEVIATION|2.97||||||||||||||||
74004288|NCT01519466|147557871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.49||0.3251|TWO_SIDED|95.0|-0.27|0.09|||t-test, 2 sided|||||0.09|-0.27|0.3251
74004289|NCT01519466|147557871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.51||||||||||||||||
74004290|NCT01519466|147557872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|1.26||0.5798|TWO_SIDED|95.0|-0.33|0.58|||t-test, 2 sided|||Hyperglycaemia, glucose above 10mmol/l (180mg/dL)||0.58|-0.33|0.5798
74004291|NCT01519466|147557872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_DEVIATION|1.03||0.096|TWO_SIDED|95.0|-0.68|0.06|||t-test, 2 sided|||Hypoglycaemia, glucose below 3.9mmol/l (70mg/dL)||0.06|-0.68|0.0960
74004292|NCT01519466|147557872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|STANDARD_DEVIATION|6.53||0.0007|TWO_SIDED|95.0|2.01|6.71|||t-test, 2 sided|||Treatment Satisfaction||6.71|2.01|0.0007
74004293|NCT00307125|147557875|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||Analysis by Fisher's exact test counting participants with 50% decrease in anti-HLA antibodies at any time within 12 months post treatment initiation||||>0.999
74004294|NCT00307125|147557880|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||||||>0.999
74004295|NCT00307125|147557881|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||||||>0.999
74004296|NCT00051363|147557883|SUPERIORITY_OR_OTHER|||||||0.0074||||||"2M E/F Function- SWMT-OMD; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).~After correction for multiple comparisons (sequential Bonferroni) P Value=0.0444 (NS)"|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M E/F Function- SWMT-OMD.||||0.0074
74038179|NCT03334396|147629673|SUPERIORITY||Mean Difference (Final Values)|-17.39|STANDARD_ERROR_OF_MEAN|7.13||0.015|TWO_SIDED|95.0|-31.43|-3.35|||Mixed Models Analysis|||||-3.35|-31.43|0.015
74038180|NCT03334396|147629673|SUPERIORITY||Mean Difference (Final Values)|-24.5|STANDARD_ERROR_OF_MEAN|6.71|<|0.001|TWO_SIDED|95.0|-37.71|-11.3|||Mixed Models Analysis|||||-11.30|-37.71|<0.001
74038181|NCT03334396|147629674|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|1.19||0.028|TWO_SIDED|95.0|-4.98|-0.29|||Mixed Models Analysis|||||-0.29|-4.98|0.028
74038182|NCT03334396|147629674|SUPERIORITY||Mean Difference (Final Values)|-3.58|STANDARD_ERROR_OF_MEAN|1.17||0.003|TWO_SIDED|95.0|-5.89|-1.27|||Mixed Models Analysis|||||-1.27|-5.89|0.003
74038183|NCT03334396|147629674|SUPERIORITY||Mean Difference (Final Values)|-5.16|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.33|-2.99|||Mixed Models Analysis|||||-2.99|-7.33|<0.001
74038184|NCT03334396|147629675|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.069|TWO_SIDED|95.0|-0.56|0.02|||Mixed Models Analysis|||||0.02|-0.56|0.069
74038185|NCT03334396|147629675|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.066|TWO_SIDED|95.0|-0.56|0.02|||Mixed Models Analysis|||||0.02|-0.56|0.066
74038186|NCT03334396|147629675|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.73|-0.19|||Mixed Models Analysis|||||-0.19|-0.73|<0.001
74004297|NCT00051363|147557883|SUPERIORITY_OR_OTHER|||||||0.2254||||||6M E/F Function- SWMT-OMD; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M E/F Function- SWMT-OMD.||||0.2254
74004298|NCT00051363|147557884|SUPERIORITY_OR_OTHER|||||||0.4538||||||DX A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for DX A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.4538
74004299|NCT00051363|147557884|SUPERIORITY_OR_OTHER|||||||0.086||||||2M A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 2M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.0860
74004300|NCT00051363|147557884|SUPERIORITY_OR_OTHER|||||||0.2103||||||6M A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 6M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.2103
74004301|NCT00051363|147557885|SUPERIORITY_OR_OTHER|||||||0.7936||||||DX L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for DX L/M Function- BSRT-SR.||||0.7936
74004302|NCT00051363|147557885|SUPERIORITY_OR_OTHER|||||||0.5444||||||2M L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M L/M Function- BSRT-SR.||||0.5444
74004303|NCT00051363|147557885|SUPERIORITY_OR_OTHER|||||||0.7569||||||6M L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M L/M Function- BSRT-SR.||||0.7569
74004304|NCT00051363|147557886|SUPERIORITY_OR_OTHER|||||||0.5606||||||"2M L/M Function- PN-RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.5606
74004305|NCT00051363|147557886|SUPERIORITY_OR_OTHER|||||||0.6487||||||"2M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.6487
74004306|NCT00051363|147557886|SUPERIORITY_OR_OTHER|||||||0.5667||||||"2M L/M Function- PN-RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.5667
74038187|NCT03334396|147629676|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.43||0.305|TWO_SIDED|95.0|-1.3|0.41|||Mixed Models Analysis|||HADS Anxiety||0.41|-1.30|0.305
74038188|NCT03334396|147629676|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.42||0.029|TWO_SIDED|95.0|-1.77|-0.1|||Mixed Models Analysis|||HADS Anxiety||-0.10|-1.77|0.029
74038189|NCT03334396|147629676|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.4||0.004|TWO_SIDED|95.0|-1.93|-0.36|||Mixed Models Analysis|||HADS Anxiety||-0.36|-1.93|0.004
74038190|NCT03334396|147629676|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.43||0.113|TWO_SIDED|95.0|-1.51|0.16|||Mixed Models Analysis|||HADS Depression||0.16|-1.51|0.113
74038191|NCT03334396|147629676|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.42||0.014|TWO_SIDED|95.0|-1.85|-0.22|||Mixed Models Analysis|||HADS Depression||-0.22|-1.85|0.014
74038192|NCT03334396|147629676|SUPERIORITY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.39||0.004|TWO_SIDED|95.0|-1.91|-0.37|||Mixed Models Analysis|||HADS Depression||-0.37|-1.91|0.004
74004307|NCT00051363|147557886|SUPERIORITY_OR_OTHER|||||||0.3972||||||"6M L/M Function- PN-RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3972
74038193|NCT03334396|147629677|SUPERIORITY||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.89||0.015|TWO_SIDED|95.0|-3.92|-0.42|||Mixed Models Analysis|||||-0.42|-3.92|0.015
74004308|NCT00051363|147557886|SUPERIORITY_OR_OTHER|||||||0.3973||||||"6M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3973
74004309|NCT00051363|147557886|SUPERIORITY_OR_OTHER|||||||0.3055||||||"6M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3055
74004310|NCT00051363|147557887|SUPERIORITY_OR_OTHER|||||||0.3699||||||"2M A/P Function- PVT-MedRT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3699
74004311|NCT00051363|147557887|SUPERIORITY_OR_OTHER|||||||0.9673||||||"2M A/P Function- PVT-MedRT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9673
74008933|NCT01286454|147568260|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|111.23|||||TWO_SIDED|90.0|102.69|120.47||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||120.47|102.69|
74008934|NCT01286454|147568260|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.07|||||TWO_SIDED|90.0|95.16|111.64||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||111.64|95.16|
73878182|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.115|TWO_SIDED|95.0|-0.52|0.06|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.06|-0.52|0.115
74008935|NCT01286454|147568260|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|70.36|||||TWO_SIDED|90.0|64.52|76.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||76.74|64.52|
74008936|NCT01286454|147568260|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|113.55|||||TWO_SIDED|90.0|105.91|121.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||121.74|105.91|
74004312|NCT00051363|147557887|SUPERIORITY_OR_OTHER|||||||0.3426||||||"2M A/P Function- PVT-MedRT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3426
74004313|NCT00051363|147557887|SUPERIORITY_OR_OTHER|||||||0.3901||||||"6M A/P Function- PVT-MedRT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3901
74004314|NCT00051363|147557887|SUPERIORITY_OR_OTHER|||||||0.9464||||||"6M A/P Function- PVT-MedRT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9464
74004315|NCT00051363|147557887|SUPERIORITY_OR_OTHER|||||||0.4372||||||"6M A/P Function- PVT-MedRT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.4372
74004316|NCT00051363|147557888|SUPERIORITY_OR_OTHER|||||||0.9656||||||"2M A/P Function- PVT-Slo10%RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9656
74004317|NCT00051363|147557888|SUPERIORITY_OR_OTHER|||||||0.6765||||||"2M A/P Function- PVT-Slo10%RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.6765
74004318|NCT00051363|147557888|SUPERIORITY_OR_OTHER|||||||0.5288||||||"2M A/P Function- PVT-Slo10%RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.5288
74004319|NCT00051363|147557888|SUPERIORITY_OR_OTHER|||||||0.7807||||||"6M A/P Function- PVT-Slo10%RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.7807
74004320|NCT00051363|147557888|SUPERIORITY_OR_OTHER|||||||0.9603||||||"6M A/P Function- PVT-Slo10%RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9603
73878183|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.532|TWO_SIDED|95.0|-0.19|0.36|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.36|-0.19|0.532
73878184|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.603|TWO_SIDED|95.0|-0.21|0.35|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.35|-0.21|0.603
73878185|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.46|TWO_SIDED|95.0|-0.38|0.17|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.17|-0.38|0.460
74004321|NCT00051363|147557888|SUPERIORITY_OR_OTHER|||||||0.3075||||||"6M A/P Function- PVT-Slo10%RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3075
74004322|NCT00051363|147557889|SUPERIORITY_OR_OTHER|||||||0.4262||||||2M L/M Function- BSRTDR-TotRec (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.4262
74004323|NCT00051363|147557889|SUPERIORITY_OR_OTHER|||||||0.3161||||||2M L/M Function- BSRTDR-TotRec (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.3161
74004324|NCT00051363|147557889|SUPERIORITY_OR_OTHER|||||||0.1835||||||2M L/M Function- BSRTDR-TotRec (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.1835
74004325|NCT00051363|147557889|SUPERIORITY_OR_OTHER|||||||0.2462||||||6M L/M Function- BSRTDR-TotRec (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.2462
74004326|NCT00051363|147557889|SUPERIORITY_OR_OTHER|||||||0.2069||||||6M L/M Function- BSRTDR-TotRec (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.2069
74004327|NCT00051363|147557889|SUPERIORITY_OR_OTHER|||||||0.5235||||||6M L/M Function- BSRTDR-TotRec (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.5235
74038194|NCT03334396|147629677|SUPERIORITY||Mean Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|0.87||0.036|TWO_SIDED|95.0|-3.56|-0.12|||Mixed Models Analysis|||||-0.12|-3.56|0.036
73878186|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.921|TWO_SIDED|95.0|-0.29|0.26|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.26|-0.29|0.921
73878187|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.172|TWO_SIDED|95.0|-0.47|0.08|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.08|-0.47|0.172
73878188|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.21|TWO_SIDED|95.0|-0.46|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.10|-0.46|0.210
74004328|NCT00051363|147557890|SUPERIORITY_OR_OTHER|||||||0.5419||||||2M E/F Function- SWMT-BehMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.5419
74004329|NCT00051363|147557890|SUPERIORITY_OR_OTHER|||||||0.89||||||2M E/F Function- SWMT-BehMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8900
74004330|NCT00051363|147557890|SUPERIORITY_OR_OTHER|||||||0.0031||||||2M E/F Function- SWMT-BehMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0031
74004331|NCT00051363|147557890|SUPERIORITY_OR_OTHER|||||||0.8703||||||6M E/F Function- SWMT-BehMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8703
74004332|NCT00051363|147557890|SUPERIORITY_OR_OTHER|||||||0.1838||||||6M E/F Function- SWMT-BehMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.1838
74004333|NCT00051363|147557890|SUPERIORITY_OR_OTHER|||||||0.0739||||||6M E/F Function- SWMT-BehMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0739
74004334|NCT00051363|147557891|SUPERIORITY_OR_OTHER|||||||0.045||||||2M E/F Function- SWMT-ActMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0450
74004335|NCT00051363|147557891|SUPERIORITY_OR_OTHER|||||||0.4512||||||2M E/F Function- SWMT-ActMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4512
74004336|NCT00051363|147557891|SUPERIORITY_OR_OTHER|||||||0.6672||||||2M E/F Function- SWMT-ActMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.6672
74038195|NCT03334396|147629677|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-5.91|-2.69|||Mixed Models Analysis|||||-2.69|-5.91|<0.001
74038196|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-4.05|STANDARD_ERROR_OF_MEAN|2.7||0.136|TWO_SIDED|95.0|-9.39|1.29|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||1.29|-9.39|0.136
74038197|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|2.76||0.898|TWO_SIDED|95.0|-5.81|5.1|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||5.10|-5.81|0.898
74038198|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|2.49||0.174|TWO_SIDED|95.0|-8.32|1.52|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||1.52|-8.32|0.174
74038199|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-6.86|STANDARD_ERROR_OF_MEAN|4.19||0.104|TWO_SIDED|95.0|-15.13|1.41|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||1.41|-15.13|0.104
74004337|NCT00051363|147557891|SUPERIORITY_OR_OTHER|||||||0.8197||||||6M E/F Function- SWMT-ActMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8197
74004338|NCT00051363|147557891|SUPERIORITY_OR_OTHER|||||||0.989||||||6M E/F Function- SWMT-ActMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.9890
74004339|NCT00051363|147557891|SUPERIORITY_OR_OTHER|||||||0.5029||||||6M E/F Function- SWMT-ActMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.5029
74004340|NCT00051363|147557892|SUPERIORITY_OR_OTHER|||||||0.9518||||||2M E/F Function- SAT-D-NumRuCh (Mild OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.9518
74004341|NCT00051363|147557892|SUPERIORITY_OR_OTHER|||||||0.4108||||||2M E/F Function- SAT-D-NumRuCh (Moderate OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4108
74004342|NCT00051363|147557892|SUPERIORITY_OR_OTHER|||||||0.4528||||||2M E/F Function- SAT-D-NumRuCh (Severe OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4528
74004343|NCT00051363|147557892|SUPERIORITY_OR_OTHER|||||||0.8391||||||6M E/F Function- SAT-D-NumRuCh (Mild OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8391
74004344|NCT00051363|147557892|SUPERIORITY_OR_OTHER|||||||0.2771||||||6M E/F Function- SAT-D-NumRuCh (Moderate OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.2771
74008937|NCT01286454|147568261|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|112.8|||||TWO_SIDED|90.0|103.85|122.52||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||122.52|103.85|
74038200|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-8.64|STANDARD_ERROR_OF_MEAN|4.28||0.045|TWO_SIDED|95.0|-17.09|-0.19|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-0.19|-17.09|0.045
74038201|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-12.28|STANDARD_ERROR_OF_MEAN|3.9||0.002|TWO_SIDED|95.0|-19.97|-4.59|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-4.59|-19.97|0.002
74038202|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-8.66|STANDARD_ERROR_OF_MEAN|4.67||0.066|TWO_SIDED|95.0|-17.89|0.57|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||0.57|-17.89|0.066
74038203|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-6.49|STANDARD_ERROR_OF_MEAN|4.76||0.175|TWO_SIDED|95.0|-15.89|2.91|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||2.91|-15.89|0.175
74038204|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-11.28|STANDARD_ERROR_OF_MEAN|4.34||0.01|TWO_SIDED|95.0|-19.84|-2.72|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||-2.72|-19.84|0.010
74004345|NCT00051363|147557892|SUPERIORITY_OR_OTHER|||||||0.8961||||||6M E/F Function- SAT-D-NumRuCh (Severe OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8961
74004346|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.654||||||DX- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.6540
74004347|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.9778||||||DX- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.9778
74004348|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.8314||||||DX- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.8314
74004349|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.5018||||||DX- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.5018
74004350|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.0052||||||2M- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.0052
74004351|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.2476||||||2M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.2476
74004352|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.752||||||2M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.7520
74004353|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.0002||||||2M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.0002
74004354|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.0022||||||6M- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.0022
74004355|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.763||||||6M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.7630
74038205|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-7.31|STANDARD_ERROR_OF_MEAN|3.36||0.03|TWO_SIDED|95.0|-13.93|-0.7|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-0.70|-13.93|0.030
74038206|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-5.13|STANDARD_ERROR_OF_MEAN|3.31||0.122|TWO_SIDED|95.0|-11.65|1.39|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||1.39|-11.65|0.122
74038207|NCT03334396|147629678|SUPERIORITY||Mean Difference (Final Values)|-16.52|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-22.64|-10.41|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-10.41|-22.64|<0.001
73878189|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.67|-0.17|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.17|-0.67|<0.001
73878190|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.016|TWO_SIDED|95.0|-0.55|-0.06|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.06|-0.55|0.016
73878191|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.025|TWO_SIDED|95.0|-0.54|-0.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.04|-0.54|0.025
73878192|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.22|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.22|-0.72|<0.001
73878193|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.083|TWO_SIDED|95.0|-0.48|0.03|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.03|-0.48|0.083
73878194|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.355|TWO_SIDED|95.0|-0.13|0.36|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.36|-0.13|0.355
73878195|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.283|TWO_SIDED|95.0|-0.11|0.38|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.38|-0.11|0.283
74004356|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.517||||||6M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.5170
74004357|NCT00051363|147557893|SUPERIORITY_OR_OTHER|||||||0.0002||||||6M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.0002
74004358|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.9291||||||DX- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.9291
74004359|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.6152||||||DX- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.6152
73878196|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.712|TWO_SIDED|95.0|-0.29|0.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.20|-0.29|0.712
74004360|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.704||||||DX- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.7040
73878197|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.877|TWO_SIDED|95.0|-0.23|0.27|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.27|-0.23|0.877
73878198|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.195|TWO_SIDED|95.0|-0.41|0.08|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.08|-0.41|0.195
73878199|NCT03084796|147295455|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.15|TWO_SIDED|95.0|-0.43|0.07|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.07|-0.43|0.150
74004361|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.9537||||||DX- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.9537
74038208|NCT03334396|147629679|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.061|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.08|-0.00|0.061
73878200|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.967||||0.016|TWO_SIDED|95.0|-1.753|-0.181|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||-0.181|-1.753|0.016
73878201|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.824||||0.039|TWO_SIDED|95.0|-1.606|-0.043|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.043|-1.606|0.039
73878202|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-1.227||||0.002|TWO_SIDED|95.0|-2.012|-0.441|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.441|-2.012|0.002
73878203|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.949||||0.018|TWO_SIDED|95.0|-1.733|-0.164|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.164|-1.733|0.018
73878204|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.566||||0.169|TWO_SIDED|95.0|-1.374|0.242|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.242|-1.374|0.169
73878205|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|0.142||||0.72|TWO_SIDED|95.0|-0.638|0.923|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.923|-0.638|0.720
73878206|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.515|TWO_SIDED|95.0|-1.043|0.523|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.523|-1.043|0.515
73878207|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.963|TWO_SIDED|95.0|-0.764|0.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.800|-0.764|0.963
73878208|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.402||||0.311|TWO_SIDED|95.0|-1.182|0.377|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.377|-1.182|0.311
74004362|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.0004||||||2M- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0004
74004363|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.3886||||||2M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.3886
74004364|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.0236||||||2M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0236
74004365|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.0005||||||2M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0005
74004366|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.0005||||||6M- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0005
74004367|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.3796||||||6M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.3796
74004368|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.0106||||||6M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0106
74004369|NCT00051363|147557894|SUPERIORITY_OR_OTHER|||||||0.001||||||6M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0010
74004370|NCT00147823|147557899|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|Using baseline (6 wk) and two year post operative predicted effects data, and setting desirable power to detect our effects to 80%||The sample size provided at least 80% power at a 5% alpha level to detect a medium to large effect in patients receiving Vitoss alone compared to combination therapy consisting of Vitoss with Bone Marrow Aspirate. Since a random coefficients model was used to analyze the data, the sample size calculation was estimated under this model assuming a 3% attrition rate between all measurement times.||||<0.01
74004371|NCT00147823|147557900|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.01
74004372|NCT00412971|147557922|SUPERIORITY_OR_OTHER||difference in recurrence rate|0.25||||0.05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.05
74004373|NCT00561951|147557934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.002||95.0|-0.56|-0.13||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.13|-0.56|0.002
74004374|NCT00561951|147557934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.6|-0.17||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.17|-0.60|<0.001
74004375|NCT00561951|147557936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.002||95.0|-0.91|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.22|-0.91|0.002
74004376|NCT00561951|147557936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||<|0.001||95.0|-1.01|-0.32|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.32|-1.01|<0.001
74004377|NCT00561951|147557938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.003||95.0|-1.07|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.22|-1.07|0.003
74004378|NCT00561951|147557938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.002||95.0|-1.09|-0.23|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.23|-1.09|0.002
74038209|NCT03334396|147629679|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.06|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.08|-0.00|0.060
74038210|NCT03334396|147629679|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|0.04|0.12|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.12|0.04|<0.001
74004379|NCT00561951|147557940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.002||95.0|-0.63|-0.14|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.14|-0.63|0.002
74004380|NCT00561951|147557940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.03||95.0|-0.52|-0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.03|-0.52|0.030
74004381|NCT00561951|147557942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.624||95.0|-0.18|0.11|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||0.11|-0.18|0.624
74004382|NCT00561951|147557942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.129||95.0|-0.26|0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||0.03|-0.26|0.129
74004383|NCT03261700|147558034|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Comparison of groups on Empowerment via the Personal Progress Scale Revised||||<.05
74004384|NCT03261700|147558035|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Comparison of groups on self-efficacy via the General Self-Efficacy Scale||||<.05
74004385|NCT04223856|147558057|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|1e-05|TWO_SIDED|95.0|0.377|0.538||P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.005.|Log Rank||HR was calculated using stratified Cox proportional hazards model.|||0.538|0.377|<0.00001
74004386|NCT04223856|147558058|SUPERIORITY|P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.01548.|Hazard Ratio (HR)|0.468|||<|1e-05|TWO_SIDED|95.0|0.376|0.582|||Log Rank||HR was calculated using stratified Cox proportional hazards model.|||0.582|0.376|<0.00001
74038211|NCT03334396|147629679|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.046|TWO_SIDED|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.11|0.00|0.046
74038212|NCT03334396|147629679|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.059|TWO_SIDED|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.11|-0.00|0.059
74038213|NCT03334396|147629679|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.06|0.16|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.16|0.06|<0.001
74038214|NCT03334396|147629680|SUPERIORITY||Mean Difference (Final Values)|2.97|STANDARD_ERROR_OF_MEAN|3.21||0.356|TWO_SIDED|95.0|-3.36|9.3|||Mixed Models Analysis|||EQ-5D-5L VAS Score||9.30|-3.36|0.356
74038215|NCT03334396|147629680|SUPERIORITY||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|3.13||0.668|TWO_SIDED|95.0|-4.81|7.5|||Mixed Models Analysis|||EQ-5D-5L VAS Score||7.50|-4.81|0.668
74038216|NCT03334396|147629680|SUPERIORITY||Mean Difference (Final Values)|7.05|STANDARD_ERROR_OF_MEAN|2.95||0.017|TWO_SIDED|95.0|1.25|12.86|||Mixed Models Analysis|||EQ-5D-5L VAS Score||12.86|1.25|0.017
74038217|NCT03334396|147629681|SUPERIORITY||Odds Ratio (OR)|1.38||||0.603|TWO_SIDED|95.0|0.41|4.71|||Regression, Logistic|||||4.71|0.41|0.603
74038218|NCT03334396|147629681|SUPERIORITY||Odds Ratio (OR)|4.08||||0.006|TWO_SIDED|95.0|1.5|11.12|||Regression, Logistic|||||11.12|1.50|0.006
74038219|NCT03334396|147629681|SUPERIORITY||Odds Ratio (OR)|4.72||||0.002|TWO_SIDED|95.0|1.78|12.55|||Regression, Logistic|||||12.55|1.78|0.002
74038220|NCT01283997|147629684|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.54|TWO_SIDED|95.0|-0.13|0.24|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the fingertip||0.24|-0.13|0.54
74038221|NCT01283997|147629684|OTHER||Mean Difference (Final Values)|0.05||||0.6|TWO_SIDED|95.0|-0.13|0.23|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the palm||0.23|-0.13|0.60
74038222|NCT01283997|147629684|OTHER||Mean Difference (Final Values)|-0.12||||0.37|TWO_SIDED|95.0|-0.4|0.15|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the forearm||0.15|-0.40|0.37
74038223|NCT01283997|147629685|OTHER||Mean Difference (Final Values)|-0.73||||0.56|TWO_SIDED|95.0|-2.06|0.59|||Wilcoxon (Mann-Whitney)|||Difference in Numbness severity at baseline and week 10.||0.59|-2.06|0.56
74038224|NCT00804843|147629704|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.27||||0.811|TWO_SIDED|90.0|-0.24|0.78|||ANOVA|||||0.78|-0.24|0.811
74038225|NCT00804843|147629705|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.64||||0.898|TWO_SIDED|90.0|-1.09|8.36|||ANOVA|||||8.36|-1.09|0.898
74038226|NCT00884221|147629719|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, ITT|2.2||||0.499|TWO_SIDED|95.0|-4.2|8.6||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin-recombinant FSH, ITT analysis set|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR - π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR - π recombinant FSH \> -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."||8.6|-4.2|0.499
74038227|NCT00884221|147629720|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Estradiol||||<0.001
74038228|NCT00884221|147629721|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||FSH||||<0.001
74038229|NCT00884221|147629722|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Free Androgen Index||||<0.001
74038230|NCT00884221|147629723|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Luteinizing hormone||||<0.001
74038231|NCT00884221|147629724|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Progesterone||||0.630
74038232|NCT00884221|147629725|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, PP|3.0||||0.387|TWO_SIDED|95.0|-3.8|9.8||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin - recombinant FSH, PP|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR - π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR - π recombinant FSH \> -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."||9.8|-3.8|0.387
74038233|NCT00884221|147629726|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Prolactin||||0.047
74038234|NCT00884221|147629727|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Sex hormone binding globulin||||0.009
74038235|NCT00884221|147629728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Testosterone||||<0.001
74038236|NCT00884221|147629729|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles \>= 12 mm on the last stimulation day||||0.025
74038237|NCT00884221|147629729|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 12-14 mm on the last stimulation day||||0.024
74038238|NCT00884221|147629729|SUPERIORITY_OR_OTHER|||||||0.728||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 15-16 mm on the last stimulation day||||0.728
74004387|NCT03226275|147558078|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.46|||||TWO_SIDED|90.0|93.25|106.09||||||Statistical Comparison of Bisoprolol in Fasting state||106.09|93.25|
74004388|NCT03226275|147558078|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|96.76|||||TWO_SIDED|90.0|92.95|100.73||||||Statistical Comparison of Amlodipine in Fasting State||100.73|92.95|
74004389|NCT03226275|147558078|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.95|||||TWO_SIDED|90.0|90.02|108.76||||||Statistical Comparison of Bisoprolol in Fed State||108.76|90.02|
74004390|NCT03226275|147558078|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|103.07|||||TWO_SIDED|90.0|95.53|111.2||||||Statistical Comparison of Amlodipine in Fed State||111.20|95.53|
74004391|NCT03226275|147558079|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|97.85|||||TWO_SIDED|90.0|92.29|103.74||||||Statistical Comparison of Bisoprolol in Fasting State||103.74|92.29|
74004392|NCT03226275|147558079|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|100.03|||||TWO_SIDED|90.0|94.37|106.03||||||Statistical Comparison of Amlodipine in Fasting State||106.03|94.37|
74004393|NCT03226275|147558079|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|93.87|||||TWO_SIDED|90.0|84.56|104.2||||||Statistical Comparison of Bisoprolol in Fed State||104.20|84.56|
74004394|NCT03226275|147558079|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|106.56|||||TWO_SIDED|90.0|97.82|116.08||||||Statistical Comparison of Amlodipine in Fed State||116.08|97.82|
74004395|NCT03226275|147558080|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.13|||||TWO_SIDED|90.0|0.0|0.5||||||Statistical Comparison of Bisoprolol in Fasting State||0.50|0.00|
74004396|NCT03226275|147558080|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.0||||||Statistical Comparison of Amlodipine in Fasting State||0.00|-1.00|
74004397|NCT03226275|147558080|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.5||||||Statistical Comparison of Bisoprolol in Fed State||0.50|-1.00|
74004398|NCT03226275|147558080|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.5||||||Statistical Comparison of Amlodipine in Fed State||0.50|-1.00|
74004399|NCT03226275|147558082|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.98|||||TWO_SIDED|90.0|93.61|106.79||||||Statistical Comparison of Bisoprolol in Fasting State||106.79|93.61|
74004400|NCT03226275|147558082|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.68|||||TWO_SIDED|90.0|93.38|104.28||||||Statistical Comparison of Amlodipine in Fasting State||104.28|93.38|
74004401|NCT03226275|147558082|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.52|||||TWO_SIDED|90.0|89.75|108.15||||||Statistical Comparison of Bisoprolol in Fed State||108.15|89.75|
74004402|NCT03226275|147558082|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|104.06|||||TWO_SIDED|90.0|96.11|112.66||||||Statistical Comparison of Amlodipine in Fed State||112.66|96.11|
74004403|NCT02864381|147558094|SUPERIORITY||Odds Ratio (OR)|1.5||||0.8|TWO_SIDED|95.0|0.4|6.1||P-value is derived from Cochran-Mantel Haenszel (CMH) test stratified by programmed death ligand 1 (PD-L1) stratification factor status.|Cochran-Mantel-Haenszel||Odds Ratio is derived from CMH test stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||6.1|0.4|0.8
74004404|NCT02864381|147558095|SUPERIORITY||Hazard Ratio (HR)|0.836||||0.306|TWO_SIDED|95.0|0.589|1.189||P-value is derived from log-rank test stratified by PD-L1 stratification factor status.|Log Rank||Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||1.189|0.589|0.306
74004405|NCT02864381|147558096|SUPERIORITY||Hazard Ratio (HR)|0.786||||0.312|TWO_SIDED|95.0|0.491|1.257||P-value is derived from log-rank test stratified by PD-L1 stratification factor status.|Log Rank||Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||1.257|0.491|0.312
74004406|NCT01806129|147558116|SUPERIORITY||Odds Ratio (OR)|2.07|||||TWO_SIDED|90.0|1.29|3.31|||||Odds ratio represents the odds of adopting the appropriate reproductive health management for patients with intervention compared to the odds among patients without intervention. Odds ratio was calculated by GEE analysis.|||3.31|1.29|
74004407|NCT03588728|147558156|SUPERIORITY|||||||0.781|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.781
74004408|NCT03588728|147558157|SUPERIORITY|||||||0.409|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.409
74004409|NCT03588728|147558158|SUPERIORITY|||||||0.697|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.697
74004410|NCT03588728|147558159|SUPERIORITY|||||||0.193|||||||ANOVA|P value indicates interaction term.||Test of between subjects effects||||.193
74004411|NCT03588728|147558160|SUPERIORITY|||||||0.185|||||||ANOVA|P value indicates the interaction term||Test of between-subjects effects||||.185
74004412|NCT03588728|147558161|SUPERIORITY|||||||0.198|||||||ANOVA|P value indicates the interaction term||Test of between-measures effects||||.198
74004413|NCT03588728|147558162|SUPERIORITY|||||||0.638|||||||ANOVA|||Test of between-subjects effects||||.638
74004414|NCT03588728|147558163|SUPERIORITY|||||||0.574|||||||ANOVA|p-value indicates the interaction term||Test of between-subjects effectd||||.574
74004415|NCT03588728|147558164|SUPERIORITY|||||||0.564|||||||ANOVA|P-value indicates the interaction term||Test of between-subjects effects||||.564
74004416|NCT03588728|147558165|SUPERIORITY|||||||0.998|||||||ANOVA|p-value indicates the interaction term||Tests of between-subjects effects||||.998
74004417|NCT03588728|147558166|SUPERIORITY|||||||0.348|||||||ANOVA|P-value indicates the interaction term||Tests of between-subjecs effects||||.348
74004418|NCT02982187|147558180|SUPERIORITY||Odds Ratio (OR)|29.114|||<|0.001|TWO_SIDED|95.0|11.047||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1: DISKUS + HandiHaler vs ELLIPTA|||11.047|<0.001
74004419|NCT02982187|147558180|SUPERIORITY||Odds Ratio (OR)|27.744|||<|0.001|TWO_SIDED|95.0|10.512||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||10.512|<0.001
74004420|NCT02982187|147558181|SUPERIORITY||Odds Ratio (OR)|4.248||||0.029|TWO_SIDED|95.0|1.416||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||1.416|0.029
74004421|NCT02982187|147558181|SUPERIORITY||Odds Ratio (OR)|3.855||||0.026|TWO_SIDED|95.0|1.394||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||1.394|0.026
74004422|NCT02982187|147558182|SUPERIORITY||Odds Ratio (OR)|2.0||||0.4|TWO_SIDED|95.0|0.459||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||0.459|0.400
74004423|NCT02982187|147558182|SUPERIORITY||Odds Ratio (OR)|1.732||||0.5|TWO_SIDED|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||0.397|0.500
74004424|NCT02982187|147558183|SUPERIORITY||Odds Ratio (OR)|24.539|||<|0.001|TWO_SIDED|95.0|9.268||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||9.268|<0.001
74004425|NCT02982187|147558183|SUPERIORITY||Odds Ratio (OR)|17.974|||<|0.001|TWO_SIDED|95.0|7.239||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||7.239|<0.001
74004426|NCT02982187|147558184|SUPERIORITY||Odds Ratio (OR)|3.237||||0.067|TWO_SIDED|95.0|1.124||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||1.124|0.067
74004427|NCT02982187|147558184|SUPERIORITY||Odds Ratio (OR)|6.357||||0.003|TWO_SIDED|95.0|2.219||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||2.219|0.003
74004428|NCT02982187|147558185|SUPERIORITY||||||||||||||stratified exact logistic model|||Sub study 1: DISKUS + HandiHaler vs ELLIPTA|These statistics were only presented when the model successfully converged. A stratified exact logistic model was used with participant included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|||
74004429|NCT02982187|147558185|SUPERIORITY||Odds Ratio (OR)|1.732||||0.5|TWO_SIDED|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||0.397|0.500
74004430|NCT02982187|147558186|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 1:DISKUS + HandiHaler vs ELLIPTA||||<0.001
74004431|NCT02982187|147558186|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA||||<0.001
73878209|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.124||||0.754|TWO_SIDED|95.0|-0.903|0.654|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.654|-0.903|0.754
73878210|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|0.278||||0.485|TWO_SIDED|95.0|-0.503|1.06|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.060|-0.503|0.485
74004432|NCT02982187|147558190|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74004433|NCT02982187|147558190|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74004434|NCT02982187|147558191|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74004435|NCT02982187|147558191|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74004436|NCT02168842|147558214|EQUIVALENCE|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.79||||0.073|TWO_SIDED|95.0|0.61|1.03|||Log Rank|||||1.03|0.61|0.073
74004437|NCT02168842|147558215|EQUIVALENCE|Comparison the risk of need for dyskinesia in Isradipine group to the risk in a placebo group.|Hazard Ratio (HR)|1.53||||0.21|TWO_SIDED|95.0|0.78|3.01|||Log Rank|||||3.01|0.78|0.21
74004438|NCT02168842|147558216|EQUIVALENCE|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.83||||0.35|TWO_SIDED|95.0|0.56|1.22|||Log Rank|||||1.22|0.56|0.35
74004439|NCT00394953|147558231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.83|3.79|||Chi-squared, Corrected|||The proportion of responders treated with methoxy polyethylene glycol-epoetin beta versus the proportion of responders treated with darbepoetin alpha during the evaluation period.||3.79|1.83|<0.0001
74004440|NCT01592864|147558343|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.2||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.2|-0.6|<0.0001
74004441|NCT01592864|147558344|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.3|-0.6|<0.0001
74004442|NCT01592864|147558345|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.9|||<|0.0001|TWO_SIDED|95.0|11.1|22.8||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||22.8|11.1|<0.0001
74004443|NCT01592864|147558346|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.6|||<|0.0001|TWO_SIDED|95.0|5.4|13.9||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favors first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||13.9|5.4|<0.0001
73878211|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-1.349||||0.005|TWO_SIDED|95.0|-2.294|-0.403|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.403|-2.294|0.005
74004444|NCT02120716|147558349|OTHER|Logistic regression analysis.|Odds Ratio (OR)|5.5||||0.13|TWO_SIDED|95.0|0.6|51.2|||Regression, Logistic|||||51.2|0.6|0.13
74004445|NCT02120716|147558350|SUPERIORITY||Odds Ratio (OR)|11.7|||<|0.015|TWO_SIDED|95.0|4.2|33.0|||Regression, Logistic|||The reported percentages were captured at two separate time points (baseline, and at 4-Month Follow-Up).||33.0|4.2|<0.015
74038239|NCT00884221|147629729|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles \>=17 mm on the last stimulation day||||0.285
74004446|NCT01326533|147558356|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANCOVA|Adjusted for baseline value as covariate||||||<0.01
74004447|NCT01326533|147558357|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANCOVA|Adjusted for baseline value as covariate||||||0.013
74004448|NCT04079803|147558358|SUPERIORITY|||||||0.087||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0088 and CFB was 13.4. In percent change from baseline with these two subjects removed, P=0.004.|||0.087
74004449|NCT04079803|147558358|SUPERIORITY|||||||0.01||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0006 and CFB was 16.9. In percent change from baseline with this subject removed, P=0.0004.|||0.01
74038240|NCT00884221|147629730|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|Only participants who underwent the oocyte retrieval procedure were included in the analysis||Treatments were compared using the Wilcoxon test for the average number of oocytes retrieved.||||<0.001
74038241|NCT00884221|147629731|SUPERIORITY_OR_OTHER|||||||0.969||95.0|||||Wilcoxon (Mann-Whitney)|Only participants who had oocytes retrieved were included in the analysis.||||||0.969
74004450|NCT04079803|147558359|SUPERIORITY||||||<|0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P\<0.0001 and CFB was -19.8.|||<0.0001
74004451|NCT04079803|147558359|SUPERIORITY|||||||0.0012||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.001 and CFB was -14.9.|||0.0012
74004452|NCT04079803|147558360|SUPERIORITY|||||||0.005||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.003 and CFB was -3.2.|||0.005
74004453|NCT04079803|147558360|SUPERIORITY|||||||0.002||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.003 and CFB was -2.5.|||0.002
74004454|NCT04079803|147558361|SUPERIORITY|||||||0.0002||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0002 and CFB was -681.|||0.0002
74004455|NCT04079803|147558361|SUPERIORITY|||||||0.0005||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0005 and CFB was -527.|||0.0005
74004456|NCT04079803|147558362|SUPERIORITY|||||||0.0003||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0002 and CFB was -78.5.|||0.0003
74038242|NCT00884221|147629732|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 1 / 2pn||||0.406
74038243|NCT00884221|147629732|SUPERIORITY_OR_OTHER|||||||0.232||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 2 / 2pn||||0.232
74038244|NCT00884221|147629732|SUPERIORITY_OR_OTHER|||||||0.412||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 3 / 2pn||||0.412
74038245|NCT00884221|147629732|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 4 / 2pn||||0.438
74038246|NCT00884221|147629732|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 5 / 2pn||||0.390
74038247|NCT00884221|147629732|SUPERIORITY_OR_OTHER|||||||0.958||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 4AA / 2pn||||0.958
74038248|NCT00884221|147629732|SUPERIORITY_OR_OTHER|||||||0.954||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 5AA / 2pn||||0.954
74038249|NCT00884221|147629733|SUPERIORITY_OR_OTHER||Comparison of distributions|0.398||||0.398|TWO_SIDED|95.0|-3.6|9.1|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set|||9.1|-3.6|0.398
74038250|NCT00884221|147629734|SUPERIORITY_OR_OTHER||Comparison of distributions|1.8||||0.686|TWO_SIDED|95.0|-5.6|9.2|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in cumulative live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set|||9.2|-5.6|0.686
74038251|NCT04172701|147629735|OTHER||||||<|0.0001|||||||Individual log-linked Poisson model|||||||<0.0001
74038252|NCT04172701|147629736|OTHER||||||<|0.001|||||||Individual t-test or Wilcoxon test|||||||<0.001
74038253|NCT04172701|147629737|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74038254|NCT04172701|147629738|OTHER||Hazard Ratio (HR)|1.475|||<|0.0001|TWO_SIDED|95.0|1.308|1.663|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model.The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.663|1.308|<0.0001
74004457|NCT04079803|147558362|SUPERIORITY|||||||0.0058||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0008 and CFB was -51.0.|||0.0058
74004458|NCT04079803|147558363|SUPERIORITY|||||||0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0001 and CFB was -23.7.|||0.0001
74004459|NCT04079803|147558363|SUPERIORITY|||||||0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0002 and CFB was -20.9.|||0.0001
74004460|NCT04079803|147558364|OTHER||Effect size|0.23|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
74004461|NCT04079803|147558364|OTHER||Effect size|0.37|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
74004462|NCT04079803|147558365|OTHER||Effect size|0.46|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was almost identical (0.45) when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
74004463|NCT04079803|147558365|OTHER||Effect size|0.25|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
74004464|NCT04079803|147558366|SUPERIORITY|||||||0.0078||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for IL-6.||||0.0078
74004465|NCT04079803|147558366|SUPERIORITY|||||||0.019||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for IL-6.||||0.019
74038255|NCT04172701|147629739|OTHER|||||||0.0003|||||||Individual log-linked Poisson model|||||||0.0003
74038256|NCT04172701|147629740|OTHER|||||||0.001|||||||Individual t-test or Wilcoxon test|||||||0.001
74038257|NCT04172701|147629741|OTHER||Hazard Ratio (HR)|1.145||||0.0006|TWO_SIDED|95.0|1.059|1.237|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.237|1.059|0.0006
74038258|NCT04172701|147629742|OTHER|||||||0.00074|||||||Log Rank|||||||0.00074
74038259|NCT04172701|147629743|OTHER||||||<|0.0001|||||||Individual log-linked Poisson model|||||||<0.0001
73878212|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-1.159||||0.016|TWO_SIDED|95.0|-2.1|-0.218|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.218|-2.100|0.016
74004466|NCT04079803|147558366|SUPERIORITY|||||||0.0002||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for sTREM2.||||0.0002
74004467|NCT04079803|147558366|SUPERIORITY|||||||0.0007||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for sTREM2.||||0.0007
74004468|NCT04079803|147558366|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for HMGB1.||||0.0001
74004469|NCT04079803|147558366|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for HMGB1.||||0.0001
74038260|NCT04172701|147629744|OTHER||Hazard Ratio (HR)|1.601|||<|0.0001|TWO_SIDED|95.0|1.404|1.826|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.826|1.404|<0.0001
74038261|NCT04172701|147629745|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74038262|NCT04172701|147629746|OTHER|||||||0.2875|||||||Wilcoxon (Mann-Whitney)|||||||0.2875
74038263|NCT04172701|147629747|OTHER|||||||0.4602|||||||Individual t-test or Wilcoxon test|||||||0.4602
74038264|NCT04172701|147629748|OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||||||0.0062
74038265|NCT04172701|147629749|OTHER|||||||0.0002|||||||Individual t-test or Wilcoxon test|||||||0.0002
74038266|NCT04172701|147629750|OTHER|||||||0.4907|||||||Individual t-test or Wilcoxon test|||||||0.4907
74038267|NCT04172701|147629751|OTHER||||||<|0.001|||||||Individual t-test or Wilcoxon test|||||||<0.001
74038268|NCT04172701|147629752|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74004470|NCT04079803|147558366|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for albumin.||||0.0001
74004471|NCT04079803|147558366|SUPERIORITY|||||||0.046||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for albumin.||||0.046
74004472|NCT04079803|147558366|SUPERIORITY|||||||0.012||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for Immunoglobulin G.||||0.012
74004473|NCT04079803|147558366|SUPERIORITY|||||||0.014||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for Immunoglobulin G.||||0.014
74004474|NCT04079803|147558367|SUPERIORITY|||||||0.005||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to alpha7nAChR in subject lymphocytes. FLNA linkage to alpha7nAChR was expressed as the ratio of densitometric units of immunoblot bands of alpha7nAChR (probed with a specific antibody) to densitometric units of total FLNA.||||0.005
74004475|NCT04079803|147558367|SUPERIORITY|||||||0.009||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to alpha7nAChR in subject lymphocytes. FLNA linkage to alpha7nAChR was expressed as ratios of densitometric units of immunoblot bands of alpha7nAChR (probed with a specific antibody) to densitometric units of total FLNA.||||0.009
74004476|NCT04079803|147558367|SUPERIORITY|||||||0.01||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to TLR4 in subject lymphocytes. FLNA linkage to TLR4 was expressed as the ratio of densitometric units of immunoblot bands of TLR4 (probed with a specific antibody) to densitometric units of total FLNA.||||0.01
74004477|NCT04079803|147558367|SUPERIORITY|||||||0.01||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to TLR4 in subject lymphocytes. FLNA linkage to TLR4 was expressed as the ratio of densitometric units of immunoblot bands of TLR4 (probed with a specific antibody) to densitometric units of total FLNA.||||0.01
74004478|NCT04079803|147558368|SUPERIORITY|||||||0.01|||||||ANOVA|ANOVA followed by Dunnett's multiple comparisons test.||||||0.01
74004479|NCT04079803|147558368|SUPERIORITY|||||||0.02|||||||ANOVA|ANOVA followed by Dunnett's multiple comparisons test.||||||0.02
74004480|NCT04079803|147558368|SUPERIORITY|||||||0.009|||||||ANOVA|This p value is for the main effect of treatment of the ANOVA.||||||0.009
74038269|NCT04172701|147629753|OTHER|||||||0.543|||||||Individual t-test or Wilcoxon test|||||||0.543
74004481|NCT04079803|147558369|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
74038270|NCT04172701|147629754|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.080
74004482|NCT04079803|147558369|SUPERIORITY|||||||0.016|||||||ANOVA|||||||0.016
73878213|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-1.466||||0.003|TWO_SIDED|95.0|-2.416|-0.516|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.516|-2.416|0.003
74004483|NCT01294683|147558372|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.206||||0.654|TWO_SIDED|95.0|-1.434|0.936|||Miettinen and Nurminen|||Periods I/II||0.936|-1.434|0.654
74004484|NCT01294683|147558372|SUPERIORITY_OR_OTHER||Difference in Percentages|1.304||||0.09|TWO_SIDED|95.0|-0.427|3.768|||Miettinen and Nurminen|||Period III||3.768|-0.427|0.090
74004485|NCT01294683|147558373|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.206||||0.563|TWO_SIDED|95.0|-1.303|0.779|||Miettinen and Nurminen|||Periods I/II||0.779|-1.303|0.563
74004486|NCT01294683|147558373|SUPERIORITY_OR_OTHER||Difference in Percentages|0.87||||0.166|TWO_SIDED|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III||3.118|-0.858|0.166
74004487|NCT01294683|147558375|SUPERIORITY_OR_OTHER||Difference in Percentages|0.87||||0.166|TWO_SIDED|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III||3.118|-0.858|0.166
74004488|NCT01294683|147558378|SUPERIORITY_OR_OTHER||Difference in Percentages|0.617||||0.255|TWO_SIDED|95.0|-0.575|2.023|||Miettinen and Nurminen|||Periods I/II||2.023|-0.575|0.255
74004489|NCT01294683|147558378|SUPERIORITY_OR_OTHER||Difference in Percentages|0.395||||0.69|TWO_SIDED|95.0|-2.091|2.966|||Miettinen and Nurminen|||Period III||2.966|-2.091|0.690
74038271|NCT04172701|147629755|OTHER|||||||0.363|||||||Individual t-test or Wilcoxon test|||||||0.363
74038272|NCT04172701|147629756|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
74038273|NCT04172701|147629757|OTHER|||||||0.0494|||||||Individual t-test or Wilcoxon test|||||||0.0494
74038274|NCT04172701|147629758|OTHER|||||||0.0091|||||||Individual t-test or Wilcoxon test|||||||0.0091
74038275|NCT04172701|147629759|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
74038276|NCT04172701|147629760|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
74004490|NCT01294683|147558379|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-0.967|0.967|||Miettinen and Nurminen|||Periods I/II||0.967|-0.967|>0.999
73878214|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-1.396||||0.004|TWO_SIDED|95.0|-2.337|-0.454|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.454|-2.337|0.004
74004491|NCT01294683|147558380|SUPERIORITY_OR_OTHER||Difference in Percentages|-1.029|||||TWO_SIDED|95.0|-7.301|5.252|||Miettinen and Nurminen||Miettinen and Nurminen Method|Periods I/II||5.252|-7.301|
74004492|NCT01294683|147558380|SUPERIORITY_OR_OTHER||Difference in Percentages|0.889|||||TWO_SIDED|95.0|-7.599|9.338|||||Miettinen and Nurminen Method|Period III||9.338|-7.599|
74004493|NCT01294683|147558381|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.412|||||TWO_SIDED|95.0|-4.28|3.45||||||Periods I/II||3.450|-4.280|
74004494|NCT01294683|147558381|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.533|||||TWO_SIDED|95.0|-3.916|2.619|||||Miettinen and Nurminen Method|Period III||2.619|-3.916|
74004495|NCT01881750|147558382|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Effects Regression Model|||Group X Time Interaction Cohen's d||||0.42
74004496|NCT00926211|147558398|NON_INFERIORITY_OR_EQUIVALENCE|Initial planned sample size of 26 would provide approximately 90% power if the survival rate in the implanted transected follicles is at least 40%. Sample size used was 36 with 35 participants completing the 9 month study.|Mean Difference (Net)|-1.4|STANDARD_DEVIATION|15.5||0.023|ONE_SIDED|97.5||3.9||t-test comparison to the upper limit of the non-inferiority margin|t-test, 1 sided|Paired t-test compared to the non-inferiority margin of 4 follicles.|The number of implanted hairs surviving that were harvested using the computer assisted method was subtracted from the number of implanted hairs surviving that were harvested manually.|The hypothesis to be tested is one of non-inferiority. Tests of non-inferiority are one-sided tests and the significance level will be 0.025.||3.9||0.023
74004497|NCT00926211|147558399|NON_INFERIORITY_OR_EQUIVALENCE|Study was powered for the primary efficacy outcome.|Mean Difference (Final Values)|0.045|STANDARD_DEVIATION|0.146|<|0.001|ONE_SIDED|97.5|-0.004||||t-test, 1 sided|Paired t-test.||Paired data with each subject as their own control (treatment was randomly assigned to the left or right side of the scalp). Paired difference was analyzed.|||-.004|<0.001
74004498|NCT04668586|147558400|SUPERIORITY||||||<|0.006|||||||Chi-squared|||||||<0.006
74004499|NCT04668586|147558401|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|Adjusted for four-category stratification group.||||||0.008
74004500|NCT04668586|147558403|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
74004501|NCT04668586|147558404|SUPERIORITY|||||||0.09|||||||Chi-squared, Corrected|Adjusted for four-category stratification group.||||||0.09
74004502|NCT01323634|147558405|SUPERIORITY_OR_OTHER||Least square mean difference|0.08|||<|0.001|TWO_SIDED|95.0|0.037|0.124|||ANCOVA|||||0.124|0.037|<0.001
74004503|NCT01585987|147558415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.439||||0.0972|TWO_SIDED|80.0|1.085|1.908||Significance level used: 0.2|Log Rank||The hazard ratio and its associated two-sided 80% confidence interval (CI) was estimated via a stratified Cox model with treatment arm as the only covariate in the model|||1.908|1.085|0.0972
74004504|NCT01585987|147558416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.588||||0.0336|TWO_SIDED|80.0|1.199|2.103||Significance level used: 0.2|Log Rank|||||2.103|1.199|0.0336
74004505|NCT01585987|147558417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.6433|TWO_SIDED|80.0|0.602|1.269||Significance level used: 0.2|Log Rank||HR was based on a stratified Cox proportional hazards model with treatment arm as the only covariate in the model.|||1.269|0.602|0.6433
74004506|NCT01585987|147558419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0549||||0.3686|TWO_SIDED|80.0|0.7009|47.6447||Significance level used: 0.2|Cochran-Mantel-Haenszel|||||47.6447|0.7009|0.3686
74004507|NCT00413972|147558435|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
74004508|NCT00413972|147558435|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
74004509|NCT00413972|147558435|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
74004510|NCT02678247|147558448|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|1.5|<|0.001|TWO_SIDED|95.0|0.8|2.3||alpha = 0.05|t-test, 2 sided|paired t-test||||2.3|0.8|<0.001
74004511|NCT02678247|147558449|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.1||0.664|TWO_SIDED|95.0|-0.06|0.04||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||0.04|-0.06|0.664
74004512|NCT02678247|147558450|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|3.05||0.026|TWO_SIDED|95.0|-3.17|-0.23||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||-0.23|-3.17|0.026
74004513|NCT02678247|147558451|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|4.58||0.847|TWO_SIDED|95.0|-2.0|2.42||p-value was adjusted using a Bonferonni correction with alpha set at 0.025|t-test, 2 sided|paired t-test||||2.42|-2|0.847
74004514|NCT02678247|147558452|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_DEVIATION|2.87|<|0.017|TWO_SIDED|95.0|-2.42|0.34||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||0.34|-2.42|<0.017
74004515|NCT02678247|147558453|OTHER||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|4.58||0.7|TWO_SIDED|95.0|-0.53|0.77||p-value was adjusted using a Bonferonni correction with alpha set at 0.025|t-test, 2 sided|paired t-test||||0.77|-0.53|0.7
74004516|NCT02678247|147558454|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_DEVIATION|8.9||0.2|TWO_SIDED|95.0|-1.6|7.0||alpha = 0.05|t-test, 2 sided|paired t-test||||7.0|-1.6|0.20
74004517|NCT02678247|147558455|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|10.0||0.62|TWO_SIDED|95.0|-6.0|3.7||alpha = 0.05|t-test, 2 sided|paired t-test||||3.7|-6.0|0.62
74004518|NCT02678247|147558456|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|5.7||0.07|TWO_SIDED|95.0|-0.2|5.3||alpha = 0.05|t-test, 2 sided|paired t-test||||5.3|-0.2|0.07
74004519|NCT02678247|147558457|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|6.3||0.18|TWO_SIDED|95.0|-5.4|1.1||alpha = 0.05|t-test, 2 sided|paired t-test||||1.1|-5.4|0.18
74004520|NCT02678247|147558458|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|1.3||0.47|TWO_SIDED|95.0|-0.4|0.9||alpha = 0.05|t-test, 2 sided|paired t-test||||0.9|-0.4|0.47
74038277|NCT04172701|147629761|OTHER|||||||0.7298|||||||Individual t-test or Wilcoxon test|||||||0.7298
74004521|NCT02678247|147558459|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|3.5||0.68|TWO_SIDED|95.0|-1.4|2.0||alpha = 0.05|t-test, 2 sided|paired t-test||||2.0|-1.4|0.68
74004522|NCT03933774|147558481|SUPERIORITY|||||||0.002||||||P value \< 0.05 was considered significant.|t-test, 2 sided|||Null hypothesis: The degree of hyperpigmentation is the same between the tretinoin applied side and placebo applied side.||||0.002
74004523|NCT03933774|147558482|SUPERIORITY|||||||0.479||||||P value \< 0.05 was considered significant.|McNemar|||Null hypothesis: The number of participants who showed ≥75% repigmentation is the same between the tretinoin applied side and placebo applied side.||||0.479
74004524|NCT02382016|147558589|SUPERIORITY||ratio of geometric means|0.65||||0.0001|TWO_SIDED|95.0|0.59|0.72|||ANCOVA|ANCOVA model adjusted by treatment, background PAH-specific therapy at baseline and region as factors \& log-transformed PVR at baseline as a covariate||The null hypothesis (change of PVR at Week 12 as a ratio of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed ratio of PVR at Week 12 to baseline PVR.||0.72|0.59|0.0001
74004525|NCT02382016|147558590|SUPERIORITY||Least squares (LS) mean difference|9.73||||0.4264|TWO_SIDED|95.0|-14.5|33.95||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|mixed-effect model repeated measure||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in 6MWD (LS mean difference macitentan 10 mg - placebo).|The main analysis on 6MWD was performed using a mixed-effect model repeated measure (MMRM) adjusted for treatment, visit, region, PAH-specific therapy at baseline, and treatment-by-visit interaction as factors, and baseline 6MWD and WHO functional class (FC) as covariates.||33.95|-14.50|0.4264
74004526|NCT02382016|147558591|SUPERIORITY||Odds Ratio (OR)|6.253||||0.1278|TWO_SIDED|95.0|0.714|298.376||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|Regression, Logistic|||A logistic regression model (exact) adjusted for treatment, PAH-specific therapy at baseline, and region as covariates was used to analyze worsening in WHO FC.||298.376|0.714|0.1278
74004527|NCT02382016|147558592|SUPERIORITY||ratio of geometric means|0.874||||0.3951|TWO_SIDED|95.0|0.639|1.196||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA|||||1.196|0.639|0.3951
74004528|NCT02382016|147558593|SUPERIORITY||Least squares (LS) mean difference|1.67||||0.0637|TWO_SIDED|95.0|-0.1|3.44||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mRAP (LS mean difference macitentan 10 mg - placebo).|||3.44|-0.10|0.0637
74004529|NCT02382016|147558594|SUPERIORITY||Least squares (LS) mean difference|-5.99||||0.0001|TWO_SIDED|95.0|-8.4|-3.57||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mPAP (LS mean difference macitentan 10 mg - placebo).|||-3.57|-8.40|0.0001
74004530|NCT02382016|147558595|SUPERIORITY||Least squares (LS) mean difference|0.52||||0.0009|TWO_SIDED|95.0|0.22|0.81||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in cardiac index (LS mean difference macitentan 10 mg - placebo).|||0.81|0.22|0.0009
74038278|NCT04172701|147629762|OTHER|||||||0.0093|||||||Individual t-test or Wilcoxon test|||||||0.0093
74038279|NCT04172701|147629763|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
74038280|NCT04172701|147629764|OTHER||Cost ratio|1.177|||<|0.0001|TWO_SIDED|95.0|1.104|1.255|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.255|1.104|<0.0001
74038281|NCT04172701|147629765|OTHER||Cost ratio|1.194||||0.0103|TWO_SIDED|95.0|1.043|1.367|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.367|1.043|0.0103
74038282|NCT04172701|147629766|OTHER||Cost ratio|1.104||||0.003|TWO_SIDED|95.0|1.034|1.178|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.178|1.034|0.0030
74004531|NCT02382016|147558596|SUPERIORITY||Least squares (LS) mean difference|-171.48||||0.0001|TWO_SIDED|95.0|-223.67|-119.3||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in TPR (LS mean difference macitentan 10 mg - placebo).|||-119.30|-223.67|0.0001
74004532|NCT02382016|147558597|SUPERIORITY||Least squares (LS) mean difference|0.03||||0.9844|TWO_SIDED|95.0|-2.85|2.91||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in SVO2 (LS mean difference macitentan 10 mg - placebo).|||2.91|-2.85|0.9844
74004533|NCT00084266|147558598|NON_INFERIORITY_OR_EQUIVALENCE|The final p-value was compared against an O'Brien-Fleming boundary of 0.048.||||||0.042|TWO_SIDED||||||Chi-squared|||"Chi-squared test was used to calculate p-value. P-value was calculated for participants with clinical outcome as cure."||||0.042
74004534|NCT00084266|147558610|SUPERIORITY_OR_OTHER|||||||0.9344|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.9344
74004535|NCT00084266|147558611|SUPERIORITY_OR_OTHER|||||||0.5985|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.5985
74038283|NCT04172701|147629767|OTHER||Cost ratio|1.175|||<|0.0001|TWO_SIDED|95.0|1.13|1.221|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.221|1.130|<0.0001
74038284|NCT04172701|147629768|OTHER||Cost ratio|1.236|||<|0.0001|TWO_SIDED|95.0|1.134|1.346|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.346|1.134|<0.0001
74038285|NCT04172701|147629769|OTHER||Cost ratio|1.214||||0.0212|TWO_SIDED|95.0|1.029|1.431|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.431|1.029|0.0212
74038286|NCT04172701|147629770|OTHER||Cost ratio|1.026||||0.5024|TWO_SIDED|95.0|0.952|1.105|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.105|0.952|0.5024
74004536|NCT00084266|147558612|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.8590
74004537|NCT02952001|147558623|SUPERIORITY|||||||0.562||||||The a priori threshold for statistical significance was 0.050. No adjustments made or required for multiplicity.|Log-rank chi-square test|||The null hypothesis of no difference in the survival time distributions was tested.||||0.562
74004538|NCT03548987|147558641|SUPERIORITY||Treatment difference|-14.75|||<|0.0001|TWO_SIDED|95.0|-16.0|-13.5|||ANCOVA|||Treatment policy estimand||-13.50|-16.00|<0.0001
74004539|NCT03548987|147558641|OTHER||Treatment difference|-15.33|||<|0.0001|TWO_SIDED|95.0|-16.52|-14.13|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||-14.13|-16.52|<0.0001
74004540|NCT00820027|147558689|SUPERIORITY||Difference in Least Squares Mean|-0.49||||0.018|TWO_SIDED|95.0|-0.89|-0.08|||longitudinal data analysis (LDA)|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.||||-0.08|-0.89|0.018
74004541|NCT00820027|147558689|SUPERIORITY||Difference in Least Squares Mean|-0.54||||0.009|TWO_SIDED|95.0|-0.95|-0.14|||LDA|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.||||-0.14|-0.95|0.009
74004542|NCT00820027|147558690|SUPERIORITY||Between-Treatment Ratio|0.69|||<|0.001|TWO_SIDED|95.0|0.56|0.85|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio \<1 indicates a beneficial effect of Etoricoxib.|||0.85|0.56|<0.001
74004543|NCT00820027|147558690|SUPERIORITY||Between-Treatment Ratio|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.82|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio \<1 indicates a beneficial effect of Etoricoxib.|||0.82|0.54|<0.001
74004544|NCT00820027|147558691|OTHER||Difference in Percent|0.5||||0.506|TWO_SIDED|95.0|-3.3|2.5|||Miettinen & Nurminen|||||2.5|-3.3|0.506
74004545|NCT00820027|147558691|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-3.8|1.7|||Miettinen & Nurminen|||||1.7|-3.8|>0.999
74004546|NCT00820027|147558691|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-3.8|1.7|||Miettinen & Nurminen|||||1.7|-3.8|>0.999
74004547|NCT00820027|147558691|OTHER||Difference in Percent|0.5||||0.316|TWO_SIDED|95.0|-1.3|2.5|||Miettinen & Nurminen|||||2.5|-1.3|0.316
74004548|NCT00820027|147558691|SUPERIORITY||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-1.7|1.7|||Miettinen & Nurminen|||||1.7|-1.7|>0.999
74004549|NCT00820027|147558691|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-1.7|3.8|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||3.8|-1.7|>0.999
74004550|NCT00820027|147558691|OTHER||Difference in Percent|-0.5||||0.309|TWO_SIDED|95.0|-2.5|1.2|||Miettinen & Nurminen|||||1.2|-2.5|0.309
74004551|NCT00820027|147558692|OTHER||Difference in Percent|-3.2||||0.054|TWO_SIDED|95.0|-9.2|0.1|||Miettinen & Nurminen|||||0.1|-9.2|0.054
74004552|NCT00820027|147558692|OTHER||Difference in Percent|-2.3||||0.209|TWO_SIDED|95.0|-8.4|1.2|||Miettinen & Nurminen|||||1.2|-8.4|0.209
74004553|NCT00820027|147558692|OTHER||Difference in Percent|-2.3||||0.227|TWO_SIDED|95.0|-8.4|1.3|||Miettinen & Nurminen|||||1.3|-8.4|0.227
74004554|NCT00820027|147558692|OTHER||Difference in Percent|-0.9||||0.415|TWO_SIDED|95.0|-3.7|1.6|||Miettinen & Nurminen|||||1.6|-3.7|0.415
74004555|NCT00820027|147558692|OTHER||Difference in Percent|-0.1||||0.965|TWO_SIDED|95.0|-3.0|2.8|||Miettinen & Nurminen|||||2.8|-3.0|0.965
74004556|NCT00820027|147558692|OTHER||Difference in Percent|2.3||||0.227|TWO_SIDED|95.0|-1.3|8.4|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||8.4|-1.3|0.227
74004557|NCT00820027|147558692|OTHER||Difference in Percent|0.8||||0.437|TWO_SIDED|95.0|-1.7|3.6|||Miettinen & Nurminen|||||3.6|-1.7|0.437
74004558|NCT00820027|147558693|OTHER||Difference in Percent|0.5||||0.806|TWO_SIDED|95.0|-5.3|4.5|||Miettinen & Nurminen|||||4.5|-5.3|0.806
74004559|NCT00820027|147558693|OTHER||Difference in Percent|-1.8||||0.278|TWO_SIDED|95.0|-7.4|1.4|||Miettinen & Nurminen|||||1.4|-7.4|0.278
74004560|NCT00820027|147558693|OTHER||Difference in Percent|0.1||||0.971|TWO_SIDED|95.0|-5.7|3.9|||Miettinen & Nurminen|||||3.9|-5.7|0.971
74004561|NCT00820027|147558693|OTHER||Difference in Percent|0.5||||0.786|TWO_SIDED|95.0|-3.2|4.2|||Miettinen & Nurminen|||||4.2|-3.2|0.786
74004562|NCT00820027|147558693|OTHER||Difference in Percent|-1.8||||0.184|TWO_SIDED|95.0|-5.2|1.0|||Miettinen & Nurminen|||||1.0|-5.2|0.184
74004563|NCT00820027|147558693|OTHER||Difference in Percent|-0.1||||0.971|TWO_SIDED|95.0|-3.9|5.7|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||5.7|-3.9|0.971
74004564|NCT00820027|147558693|OTHER||Difference in Percent|-2.3||||0.113|TWO_SIDED|95.0|-5.8|0.6|||Miettinen & Nurminen|||||0.6|-5.8|0.113
74004565|NCT00820027|147558694|OTHER||Difference in Percent|-5.3||||0.365|TWO_SIDED|95.0|-17.0|6.0|||Miettinen & Nurminen|||||6.0|-17.0|0.365
74004566|NCT00820027|147558694|OTHER||Difference in Percent|-7.2||||0.222||95.0|-18.8|4.2|||Miettinen & Nurminen|||||4.2|-18.8|0.222
74004567|NCT00820027|147558694|OTHER||Difference in Percent|-5.5||||0.349|TWO_SIDED|95.0|-17.2|5.9|||Miettinen & Nurminen|||||5.9|-17.2|0.349
74004568|NCT00820027|147558694|OTHER||Difference in Percent|0.2||||0.965|TWO_SIDED|95.0|-8.7|9.0|||Miettinen & Nurminen|||||9.0|-8.7|0.965
74004569|NCT00820027|147558694|OTHER||Difference in Percent|-1.6||||0.718|TWO_SIDED|95.0|-10.5|7.3|||Miettinen & Nurminen|||||7.3|-10.5|0.718
74004570|NCT00820027|147558694|OTHER||Difference in Percent|5.5||||0.349|TWO_SIDED|95.0|-5.9|17.2|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||17.2|-5.9|0.349
74004571|NCT00820027|147558694|OTHER||Difference in Percent|1.8||||0.684|TWO_SIDED|95.0|-7.0|10.6|||Miettinen & Nurminen|||||10.6|-7.0|0.684
74004572|NCT00820027|147558695|NON_INFERIORITY|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Difference in Least Squares Mean|-0.04|||||TWO_SIDED|95.0|-0.36|0.27||||||||0.27|-0.36|
74004573|NCT00820027|147558695|NON_INFERIORITY|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.42|0.22||||||||0.22|-0.42|
74004574|NCT00820027|147558696|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.05|||||TWO_SIDED|95.0|0.89|1.23|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.23|0.89|
74004575|NCT00820027|147558696|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.01|||||TWO_SIDED|95.0|0.85|1.18|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.18|0.85|
74004576|NCT00820027|147558696|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.04|||||TWO_SIDED|95.0|0.89|1.23|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.23|0.89|
74038287|NCT04172701|147629771|OTHER||Cost ratio|1.304|||<|0.0001|TWO_SIDED|95.0|1.243|1.369|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.369|1.243|<0.0001
74038288|NCT04172701|147629772|OTHER|||||||0.7198|||||||Individual log-linked Poisson model|||||||0.7198
74038289|NCT04172701|147629773|OTHER||Hazard Ratio (HR)|1.072||||0.7341|TWO_SIDED|95.0|0.719|1.598|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.598|0.719|0.7341
74038290|NCT04172701|147629774|OTHER|||||||0.74|||||||Log Rank|||||||0.74
74004577|NCT01128894|147558704|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was from a 1-sided t test testing whether or not the difference of least square means (albiglutide - liraglutide) was less than or equal to the prespecified noninferiority margin of 0.3%.|Mean Difference (Final Values)|0.21||||0.0846|TWO_SIDED|95.0|0.08|0.34|||ANCOVA|||||0.34|0.08|0.0846
74004578|NCT00195507|147558711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.64|-0.43|||ANCOVA|Treatment and center as main effects, and baseline score as a covariant.||||-0.43|-0.64|<0.001
74004579|NCT00195507|147558712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74038291|NCT04172701|147629775|OTHER|||||||0.9985|||||||Individual log-linked Poisson model|||||||0.9985
74038292|NCT04172701|147629776|OTHER||Hazard Ratio (HR)|0.879||||0.5097|TWO_SIDED|95.0|0.6|1.289|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.289|0.600|0.5097
74038293|NCT04172701|147629777|OTHER|||||||0.51|||||||Log Rank|||||||0.51
74038294|NCT04172701|147629778|OTHER|||||||0.6069|||||||Individual log-linked Poisson model|||||||0.6069
74038295|NCT04172701|147629779|OTHER||Hazard Ratio (HR)|1.025||||0.896|TWO_SIDED|95.0|0.705|1.49|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.490|0.705|0.8960
73878215|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.824||||0.097|TWO_SIDED|95.0|-1.797|0.15|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.150|-1.797|0.097
73878216|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.69|TWO_SIDED|95.0|-0.746|1.126|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.126|-0.746|0.690
73878217|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.117||||0.808|TWO_SIDED|95.0|-1.061|0.827|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.827|-1.061|0.808
73878218|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.922|TWO_SIDED|95.0|-0.983|0.889|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.889|-0.983|0.922
74004580|NCT00195507|147558714|SUPERIORITY_OR_OTHER|||||||0.143|||||||Fisher Exact|||||||0.143
74004581|NCT00973362|147558715|SUPERIORITY_OR_OTHER||Sensitivity (%)|75.0|||||TWO_SIDED|95.0|53.1|88.8||||||||88.8|53.1|
74004582|NCT00973362|147558715|SUPERIORITY_OR_OTHER||Specificity (%)|62.6|||||TWO_SIDED|95.0|59.2|65.9||||||||65.9|59.2|
74004583|NCT00973362|147558715|SUPERIORITY_OR_OTHER||Positive Predictive Value [PPV] (%)|4.8|||||TWO_SIDED|95.0|3.4|5.8||||||||5.8|3.4|
74004584|NCT00973362|147558715|SUPERIORITY_OR_OTHER||Negative Predictive Value [NPV] (%)|99.0|||||TWO_SIDED|95.0|98.1|99.6||||||||99.6|98.1|
73878219|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.307||||0.522|TWO_SIDED|95.0|-1.248|0.634|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.634|-1.248|0.522
73878220|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.237||||0.618|TWO_SIDED|95.0|-1.17|0.696|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.696|-1.170|0.618
73878221|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.884|TWO_SIDED|95.0|-0.871|1.012|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.012|-0.871|0.884
74004585|NCT00973362|147558715|SUPERIORITY_OR_OTHER||Prevalence (%)|2.4|||||TWO_SIDED|||||||||||||
73878222|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-1.158||||0.006|TWO_SIDED|95.0|-1.978|-0.337|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.337|-1.978|0.006
73878223|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.992||||0.017|TWO_SIDED|95.0|-1.808|-0.175|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.175|-1.808|0.017
74004586|NCT00973362|147558715|SUPERIORITY_OR_OTHER||Relative Risk|4.8|||||TWO_SIDED|95.0|1.8|13.1|||||The relative risk of CIN2+ is defined as the \[ absolute risk of APTIMA HPV (Positive Result) / absolute risk of APTIMA HPV (Negative Result) \] .|||13.1|1.8|
74004587|NCT00973362|147558716|SUPERIORITY_OR_OTHER||Sensitivity (%)|84.2|||||TWO_SIDED|95.0|62.4|94.5||||||||94.5|62.4|
74004588|NCT00973362|147558716|SUPERIORITY_OR_OTHER||Specificity (%)|48.7|||||TWO_SIDED|95.0|45.2|52.2||||||||52.2|45.2|
74004589|NCT00973362|147558716|SUPERIORITY_OR_OTHER||Positive Predictive Value [PPV] (%)|3.8|||||TWO_SIDED|95.0|2.9|4.4||||||||4.4|2.9|
74004590|NCT00973362|147558716|SUPERIORITY_OR_OTHER||Negative Predictive Value [NPV] (%)|99.2|||||TWO_SIDED|95.0|98.1|99.8||||||||99.8|98.1|
74004591|NCT00973362|147558716|SUPERIORITY_OR_OTHER||Prevalence (%)|2.4|||||TWO_SIDED|||||||||||||
74004592|NCT00973362|147558716|SUPERIORITY_OR_OTHER||Relative Risk|4.9|||||TWO_SIDED|95.0|1.4|16.7|||||The relative risk of CIN2+ is defined as the \[ absolute risk of FDA-Approved HPV DNA Assay (Positive Result) / absolute risk of FDA-Approved HPV DNA Assay (Negative Result) \] .|||16.7|1.4|
74004593|NCT00973362|147558717|SUPERIORITY_OR_OTHER||Sensitivity(%)|86.8|||||TWO_SIDED|95.0|78.4|92.3||||||||92.3|78.4|
74004594|NCT00973362|147558717|SUPERIORITY_OR_OTHER||Specificty|62.9|||||TWO_SIDED|95.0|59.6|66.0||||||||66.0|59.6|
74004595|NCT00973362|147558717|SUPERIORITY_OR_OTHER||PPV|20.1|||||TWO_SIDED|95.0|18.1|22.0||||||||22.0|18.1|
74004596|NCT00973362|147558717|SUPERIORITY_OR_OTHER||NPV|97.8|||||TWO_SIDED|95.0|96.5|98.8||||||||98.8|96.5|
74004597|NCT00973362|147558717|SUPERIORITY_OR_OTHER||Prevalence (%)|9.7|||||TWO_SIDED|||||||||||||
74004598|NCT00973362|147558718|SUPERIORITY_OR_OTHER||Sensitivity (%)|88.8|||||TWO_SIDED|95.0|80.5|93.8||||||||93.8|80.5|
74004599|NCT00973362|147558718|SUPERIORITY_OR_OTHER||Specificity(%)|55.8|||||TWO_SIDED|95.0|52.3|59.3||||||||59.3|52.3|
74004600|NCT00973362|147558718|SUPERIORITY_OR_OTHER||PPV(%)|18.7|||||TWO_SIDED|95.0|17.0|20.4||||||||20.4|17.0|
74004601|NCT00973362|147558718|SUPERIORITY_OR_OTHER||NPV(%)|97.7|||||TWO_SIDED|95.0|96.2|98.8||||||||98.8|96.2|
74004602|NCT00973362|147558718|SUPERIORITY_OR_OTHER||Prevalence(%)|10.3|||||TWO_SIDED|||||||||||||
74004603|NCT01630434|147558725|NON_INFERIORITY|The non-inferiority margin, which is here taken to be 0.04.|difference of proportion|-0.091||||0.004|ONE_SIDED|95.0||-0.01|||Wald Method|||||-0.01||0.004
74004604|NCT01630434|147558725|NON_INFERIORITY|The non-inferiority margin, which is here taken to be 0.04.|difference of proportion|-0.038||||0.06|ONE_SIDED|95.0||0.045|||Wald Method|||||0.045||0.06
74004605|NCT01630434|147558726|NON_INFERIORITY|The non-inferiority margin is 5%.|Difference of proportions|-0.015||||0.0003|ONE_SIDED|95.0||0.016|||Wald Method|||||0.016||0.0003
74004606|NCT01630434|147558726|NON_INFERIORITY|The non-inferiority margin is 5%.|Difference of proportions|0.006||||0.027|ONE_SIDED|95.0||0.044|||Wald Method|||||0.044||0.027
74004607|NCT01630434|147558727|NON_INFERIORITY|The non-inferiority margin is 7.5%.|Difference of proportions|0.035||||0.118|ONE_SIDED|95.0||0.091|||Wald Method|||||0.091||0.118
74004608|NCT01630434|147558727|NON_INFERIORITY|The non-inferiority margin is 7.5%.|Difference of proportions|0.065||||0.389|ONE_SIDED|95.0||0.124|||Wald Method|||||0.124||0.389
74004609|NCT01630434|147558728|NON_INFERIORITY|The non-inferiority margin is 4%|Difference of proportions|0.043|||||ONE_SIDED|95.0||0.071||||||||0.071||
74004610|NCT01630434|147558728|NON_INFERIORITY|The non-inferiority margin is 4%.|Difference of proportions|0.054|||||ONE_SIDED|95.0||0.087||||||||0.087||
74004611|NCT01630434|147558729|NON_INFERIORITY|The non-inferiority margin is 0.7.|Mean Difference (Final Values)|-0.045|||<|0.0001|ONE_SIDED|95.0||0.047|||t-test, 2 sided|||||0.047||<0.0001
74004612|NCT01106404|147558734|SUPERIORITY_OR_OTHER||binomial proportion|0.865|||<|0.001|ONE_SIDED|97.5|0.765||||Fisher Exact||In this ITT analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|"ITT analysis:~Hypothesis: The percentage of subjects who succeed must be greater than 25%. H0: p ≤ 0.25 HA: p \> 0.25"|||0.765|< 0.001
74038296|NCT04172701|147629780|OTHER|||||||0.9|||||||Log Rank|||||||0.9
74004613|NCT01106404|147558734|SUPERIORITY_OR_OTHER||binomial proportion|0.901|||<|0.001|ONE_SIDED|97.5|0.807||||Fisher Exact||In this completed case analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|Completed case analysis|||0.807|< 0.001
74004614|NCT01106404|147558735|SUPERIORITY_OR_OTHER||binomial proportion|0.028|||||TWO_SIDED|95.0|0.003|0.098|||||The combined percentage of subjects with worsened pain relief was reported.|||0.098|0.003|
74004615|NCT01106404|147558736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.8|STANDARD_DEVIATION|51.9|<|0.001||95.0|||||Wilcoxon signed rank test|||||||< 0.001
74004616|NCT01106404|147558737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77|STANDARD_DEVIATION|1.93|<|0.001||95.0|||||Wilcoxon signed rank test|||||||< 0.001
74004617|NCT01106404|147558737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|2.04|<|0.001|TWO_SIDED|95.0|||||Wilcoxon signed rank test|||||||< 0.001
74004618|NCT03552822|147558742|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
74004619|NCT03552822|147558743|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||||||0.037
74004620|NCT03552822|147558744|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
74004621|NCT03552822|147558745|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
74004622|NCT03552822|147558746|SUPERIORITY|||||||0.108|||||||Wilcoxon (Mann-Whitney)|||||||0.108
74004623|NCT03552822|147558747|SUPERIORITY|||||||0.159|||||||Fisher Exact|||||||0.159
74004624|NCT03552822|147558748|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
74004625|NCT03552822|147558749|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
74004626|NCT03552822|147558750|SUPERIORITY|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
74004627|NCT01296347|147558818|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
74004628|NCT01296347|147558819|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||6 weeks||||0.71
74004629|NCT01296347|147558819|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||3 month||||1.0
74004630|NCT01296347|147558819|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||6 months||||0.32
74004631|NCT01296347|147558821|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
74004632|NCT01296347|147558822|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
74004633|NCT01296347|147558823|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
74004634|NCT01296347|147558824|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74004635|NCT02240693|147558825|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.075||0.3236|TWO_SIDED|95.0|-0.074|0.223||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.223|-0.074|0.3236
74008938|NCT01286454|147568261|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.71|||||TWO_SIDED|90.0|95.48|112.65||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||112.65|95.48|
74008939|NCT01286454|147568261|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|66.87|||||TWO_SIDED|90.0|61.56|72.63||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||72.63|61.56|
74008940|NCT01286454|147568261|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|28.34|||||TWO_SIDED|90.0|26.09|30.78||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.||30.78|26.09|
74004636|NCT02240693|147558825|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.076||0.3694|TWO_SIDED|95.0|-0.22|0.082||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.082|-0.220|0.3694
74004637|NCT02240693|147558825|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.078||0.8374|TWO_SIDED|95.0|-0.171|0.139||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.139|-0.171|0.8374
74004638|NCT02240693|147558825|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.077||0.5484|TWO_SIDED|95.0|-0.106|0.199||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.199|-0.106|0.5484
74004639|NCT02240693|147558825|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.054||0.7905|TWO_SIDED|95.0|-0.092|0.121||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.121|-0.092|0.7905
74004640|NCT02240693|147558826|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|1.102||0.8973|TWO_SIDED|95.0|-2.33|2.04||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|2.04|-2.33|0.8973
74004641|NCT02240693|147558826|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.122||0.2141|TWO_SIDED|95.0|-0.82|3.63||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|3.63|-0.82|0.2141
74004642|NCT02240693|147558826|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.085||0.6553|TWO_SIDED|95.0|-2.64|1.67||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|1.67|-2.64|0.6553
74004643|NCT02240693|147558826|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|1.144||0.7166|TWO_SIDED|95.0|-1.85|2.69||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|2.69|-1.85|0.7166
74004644|NCT02240693|147558827|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.9491|TWO_SIDED|95.0|-0.49|0.46||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.46|-0.49|0.9491
74004645|NCT02240693|147558827|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1699|TWO_SIDED|95.0|-0.15|0.84||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.84|-0.15|0.1699
74038297|NCT04172701|147629781|OTHER|||||||0.1354|||||||Individual log-linked Poisson model|||||||0.1354
73878224|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-1.346||||0.001|TWO_SIDED|95.0|-2.168|-0.524|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.524|-2.168|0.001
74004646|NCT02240693|147558827|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4948|TWO_SIDED|95.0|-0.69|0.33||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.33|-0.69|0.4948
74004647|NCT02240693|147558827|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.7548|TWO_SIDED|95.0|-0.42|0.58||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.58|-0.42|0.7548
74004648|NCT02240693|147558828|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|1.081||0.8137|TWO_SIDED|95.0|-2.4|1.89||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|1.89|-2.40|0.8137
74004649|NCT02240693|147558828|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|1.12||0.5801|TWO_SIDED|95.0|-2.84|1.6||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|1.60|-2.84|0.5801
74004650|NCT02240693|147558828|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.072||0.2978|TWO_SIDED|95.0|-3.25|1.0||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|1.00|-3.25|0.2978
74004651|NCT02240693|147558828|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|1.072||0.0209|TWO_SIDED|95.0|-4.64|-0.39||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|-0.39|-4.64|0.0209
73878225|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-1.172||||0.005|TWO_SIDED|95.0|-1.991|-0.353|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.353|-1.991|0.005
74004652|NCT02240693|147558829|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.8694|TWO_SIDED|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.120|-0.101|0.8694
74004653|NCT02240693|147558829|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.057||0.9512|TWO_SIDED|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.109|-0.116|0.9512
74004654|NCT02240693|147558829|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.056||0.9321|TWO_SIDED|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.115|-0.105|0.9321
74004655|NCT02240693|147558829|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.057||0.1288|TWO_SIDED|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.025|-0.199|0.1288
74004656|NCT02240693|147558829|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.041||0.6492|TWO_SIDED|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.061|-0.098|0.6492
74004657|NCT01783041|147558847|OTHER||||||<|0.05||||||These are calculated p values.|ANOVA|Differences in continuous and categorical variables were compared using ANOVA and either Chi square test or Fisher's exact test, respectively.||||||<0.05
73878226|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.695||||0.107|TWO_SIDED|95.0|-1.539|0.149|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.149|-1.539|0.107
74004658|NCT01783041|147558848|OTHER||||||<|0.05||||||These are calculated p values.|Wilcoxon (Mann-Whitney)|This analysis applies to all sub-scales that were compared between the 2 study groups.||||||<0.05
74004659|NCT01783041|147558849|OTHER||||||<|0.05||||||Reported p values have been calculated.|t-test, 2 sided|Differences between the groups were analyzed using a two sided t-test.||||||<0.05
73878227|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|0.166||||0.689|TWO_SIDED|95.0|-0.648|0.98|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.980|-0.648|0.689
73878228|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.188||||0.651|TWO_SIDED|95.0|-1.007|0.63|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.630|-1.007|0.651
74004660|NCT01783041|147558850|OTHER||||||<|0.05||||||These are calculated p values.|ANOVA|Differences in continuous and categorical variables were compared using ANOVA and either Chi square test or Fisher's exact test, respectively.||||||<0.05
74004661|NCT02092220|147558855|SUPERIORITY||Mean Difference (Final Values)|-20.28|STANDARD_DEVIATION|24.59|<|0.0001|TWO_SIDED|95.0|-28.0|-12.56||Repeated measures model.|t-test, 2 sided||Bionic Pancreas Arm - Usual Care Arm|||-12.56|-28.00|<0.0001
74004662|NCT02092220|147558856|SUPERIORITY||Mean Difference (Final Values)|1.3|||<|0.0001|TWO_SIDED|95.0|0.8|1.8||Repeated measures model.|t-test, 2 sided|||||1.8|0.8|<0.0001
74004663|NCT01231516|147558916|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority of DTG 50 mg and RAL at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - RAL) is greater than -12%. If non-inferiority were established, superiority would be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.4||||0.03|TWO_SIDED|95.0|0.7|14.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Adjusted difference in proportion which is based on the difference in percentage, adjusted for Baseline (BL) stratification factors.|Analysis was adjusted for BL stratification factors: HIV-1 RNA (\<=50000 versus \[vs\]\>50000 c/mL), darunavir-ritonavir use without primary protease inhibitor mutations (yes vs no), and phenotypic susceptibility score (2 vs \<2) to background regimen.|||14.2|0.7|0.030
74004664|NCT03170154|147558932|OTHER||1-sided 95% Upper CL|99.99|||||ONE_SIDED||||||||Historical comparison to EN ISO 11979-7:2014: SPE rate of at least 92.5 for the AAS at 12 months.|||||
74004665|NCT03170154|147558933|OTHER||1-sided 95% Upper CL|99.98|||||ONE_SIDED|95.0|||||||Historical comparison to EN ISO 11979-7:2014: SPE rate of at least 96.7 for the BAS at 12 months.|||||
74004666|NCT05266586|147558938|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
74004667|NCT05266586|147558939|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
74004668|NCT05266586|147558940|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
74004669|NCT05266586|147558941|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
74004670|NCT05266586|147558942|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
74004671|NCT05266586|147558943|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
74004672|NCT05266586|147558944|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
74004673|NCT05266586|147558945|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
74004674|NCT05266586|147558946|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
74004675|NCT05266586|147558947|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
74004676|NCT05266586|147558948|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
74004677|NCT05266586|147558949|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
74004678|NCT05266586|147558950|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
74004679|NCT05266586|147558951|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
74004680|NCT05266586|147558952|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
74004681|NCT05266586|147558953|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
74004682|NCT05266586|147558954|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
74004683|NCT05266586|147558955|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
74004684|NCT05245097|147558963|OTHER|For the multiple imputation, a total of 50 imputed datasets will be calculated (Graham et al.). Fully conditional specification (FCS) discriminant function method will be used to impute missing primary endpoint using the baseline covariates of age, sex, race, ethnicity, mobility level, and BIMS Score. The FCS logistic method was replaced with the FCS discriminant function method due to a quasi-separation caused by only one observed primary endpoint event in the treatment group.||||||0.004||||||The null hypothesis was tested at a one-sided 0.025 level of significance using a logistic regression analysis to compare treatment groups while controlling for propensity score.|Regression, Logistic|||||||0.004
74004685|NCT05245097|147558964|OTHER|||||||0.003||||||The hip fracture due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|||||||0.003
74004686|NCT05245097|147558964|SUPERIORITY|||||||0.003|||||||Regression, Logistic|||||||0.003
74004687|NCT05245097|147558965|SUPERIORITY|||||||0.001||||||The emergency department visit due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|Subjects with multiple ED visits due to falls are only counted once.||||||0.001
74004688|NCT05245097|147558966|SUPERIORITY|||||||0.003||||||The hospitalization due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|Subjects with multiple hospitalizations due to falls are only counted once.||||||0.003
74004689|NCT00692978|147559000|EQUIVALENCE|Log transformed parametric ANOVA|||||<|0.05||||||calculated|ANOVA|||||||<0.05
74004690|NCT00607022|147559001|OTHER|Kruskal-Wallis values between each loading group and for Wilcoxon Signed Rank for measures on the mesial vs buccal side of the implant.|||||>|0.05||||||0.0501 \< p \< 0.9797|Kruskal-Wallis|Kruskal-Wallis test evaluated ISQ at each time point..||Comparison between loading groups at 16 weeks - loading at baseline, Loading at 6 weeks, and loading at 12 weeks. Scores for all groups were compared at 16 weeks from implant placement..||||>0.05
74004691|NCT01005459|147559002|OTHER|unpaired t-test|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
74004692|NCT01005459|147559002|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
74004693|NCT03282240|147559011|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.08|||||TWO_SIDED|95.0|0.958|1.224||||||B Victoria: The 2-sided 95% confidence interval (CI) was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.224|0.958|
74004694|NCT03282240|147559011|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.0|||||TWO_SIDED|95.0|0.881|1.129||||||B Yamagata: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.129|0.881|
74004695|NCT03282240|147559011|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.83|||||TWO_SIDED|95.0|0.744|0.932||||||A/H1N1: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||0.932|0.744|
74004696|NCT03282240|147559011|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.95|||||TWO_SIDED|95.0|0.842|1.066||||||A/H3N2: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.066|0.842|
74004697|NCT03282240|147559012|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-2.41|||||TWO_SIDED|95.0|-7.66|2.7||||||B Victoria: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||2.70|-7.66|
74038298|NCT04172701|147629782|OTHER||Hazard Ratio (HR)|0.59||||0.1158|TWO_SIDED|95.0|0.305|1.139|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.139|0.305|0.1158
74038299|NCT04172701|147629783|OTHER|||||||0.11|||||||Log Rank|||||||0.11
74038300|NCT01975246|147629784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.3|-2.4|||ANCOVA|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.||-2.4|-5.3|<0.0001
74091010|NCT02037165|147735942|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.05|STANDARD_ERROR_OF_MEAN|2.8201|||TWO_SIDED|95.0|-8.7|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-8.7|
74091011|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.78|STANDARD_ERROR_OF_MEAN|2.5753|||TWO_SIDED|95.0|-8.9|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-8.9|
74004698|NCT03282240|147559012|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-1.75|||||TWO_SIDED|95.0|-7.04|3.53||||||B Yamagata: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||3.53|-7.04|
74004699|NCT03282240|147559012|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-0.71|||||TWO_SIDED|95.0|-4.83|3.42||||||A/H3N2: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||3.42|-4.83|
74091012|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.74|STANDARD_ERROR_OF_MEAN|2.5162|||TWO_SIDED|95.0|-9.8|0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.3|-9.8|
74091013|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.06|STANDARD_ERROR_OF_MEAN|2.9156|||TWO_SIDED|95.0|-11.9|-0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.3|-11.9|
74004700|NCT03282240|147559012|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-3.27|||||TWO_SIDED|95.0|-7.37|0.86||||||A/H1N1: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||0.86|-7.37|
74038301|NCT01975246|147629785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-7.6|-3.1|||ANCOVA|Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.||-3.1|-7.6|<0.0001
74038302|NCT01975246|147629786|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.0051|TWO_SIDED|95.0|1.2|3.4|||Regression, Logistic|Logistic regression model includes treatment and center as fixed effects.||"The Non-completers considered failure (NCF) method was applied for missing data, where missing data due to early discontinuation will be replaced as failure up to the planned final visit to be reached by all patients."||3.4|1.2|<0.0051
74038303|NCT01263093|147629788|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.77|||||TWO_SIDED|90.0|0.72|0.83|||Mixed Models Analysis||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.|||0.83|0.72|
74038304|NCT01263093|147629789|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.59|||||TWO_SIDED|90.0|0.53|0.67|||Mixed Models Analysis||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.|||0.67|0.53|
74004701|NCT03282240|147559013|SUPERIORITY|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was \> 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.04|||||TWO_SIDED|95.0|1.804|2.315||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||2.315|1.804|
74004702|NCT03282240|147559013|SUPERIORITY|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was \> 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.03|||||TWO_SIDED|95.0|1.802|2.288||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||2.288|1.802|
74004703|NCT03282240|147559015|SUPERIORITY|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is \> 10% for each applicable comparison.|Difference in Percentage|29.27|||||TWO_SIDED|95.0|24.78|33.29||||||B Yamagata: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.||33.29|24.78|
74004704|NCT03282240|147559015|SUPERIORITY|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is \> 10% for each applicable comparison.|Difference in Percentage|20.78|||||TWO_SIDED|95.0|16.5|24.61||||||B Victoria: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.||24.61|16.5|
74004705|NCT03254485|147559029|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.3681|TWO_SIDED|95.0|-0.95|0.35|||ANCOVA|||||0.35|-0.95|=0.3681
74004706|NCT03254485|147559030|SUPERIORITY||Least Squares Mean Difference|-16.74|||=|0.2817|TWO_SIDED|95.0|-47.38|13.9|||ANCOVA|||||13.90|-47.38|=0.2817
74004707|NCT03254485|147559031|SUPERIORITY||Least Squares Mean Difference|-0.297|||=|0.6508|TWO_SIDED|95.0|-1.591|0.997|||ANCOVA|||||0.997|-1.591|=0.6508
74004708|NCT02910739|147559033|OTHER|The pharmacokinetic condition to initiate Part 2 of the study would be met if the point estimate for the AUC0-∞ ratio of geometric means (participants with moderate HI / healthy matched control participants) exceeds 1.5.|Geometric least-squares mean ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.83|1.3|||||GMR = geometric least squares mean (GLSM) for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-∞; no hypothesis testing was planned for this outcome measure.||1.30|0.83|
74004709|NCT02910739|147559034|OTHER||GMR|1.07|||||TWO_SIDED|90.0|0.77|1.5|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on Cmax; no hypothesis testing was planned for this outcome measure.||1.50|0.77|
74004710|NCT02910739|147559035|OTHER||GMR|1.04|||||TWO_SIDED|90.0|0.82|1.31|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-last; no hypothesis testing was planned for this outcome measure.||1.31|0.82|
74004711|NCT02910739|147559036|OTHER||GMR|1.01|||||TWO_SIDED|90.0|0.8|1.27|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-24hr; no hypothesis testing was planned for this outcome measure.||1.27|0.80|
74004712|NCT02910739|147559037|OTHER||GMR|1.08|||||TWO_SIDED|90.0|0.9|1.3|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on C24hr; no hypothesis testing was planned for this outcome measure.||1.30|0.90|
74004713|NCT02146326|147559044|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.80
74004714|NCT02146326|147559045|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.80
74004715|NCT02146326|147559046|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.54
74004716|NCT02146326|147559047|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.94
74004717|NCT02146326|147559048|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.96
74004718|NCT02146326|147559049|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.17
74004719|NCT02146326|147559050|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.47
74004720|NCT02146326|147559051|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.60
74038305|NCT01263093|147629791|SUPERIORITY_OR_OTHER||Median of Paired Differences|0.0||||0.3303|TWO_SIDED|90.0|0.0|0.25|||Wilcoxon (Mann-Whitney)|||||0.25|0.00|0.3303
74038306|NCT03292952|147629852|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
74004721|NCT02146326|147559052|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.37
74004722|NCT02146326|147559053|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.83
74004723|NCT02146326|147559054|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.64
74004724|NCT02146326|147559055|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.37
74004725|NCT02146326|147559056|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.13
74004726|NCT02146326|147559057|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.93
74004727|NCT02146326|147559058|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.11
74004728|NCT02146326|147559059|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.21
74038307|NCT02667457|147629863|OTHER|||||||0.0095||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0095
74004729|NCT02146326|147559061|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.17
74004730|NCT02146326|147559062|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
74004731|NCT02146326|147559063|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
74004732|NCT02146326|147559064|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.67
74004733|NCT02146326|147559065|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.04
74004734|NCT02146326|147559066|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.34
74004735|NCT02146326|147559067|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.71
74004736|NCT02146326|147559068|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.22
74004737|NCT02146326|147559069|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.11
74038308|NCT02667457|147629863|OTHER|||||||0.0029||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0029
74004738|NCT02146326|147559070|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.14
74004739|NCT02146326|147559071|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.55
74004740|NCT02146326|147559072|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.91
74004741|NCT02146326|147559073|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.48
74004742|NCT02146326|147559074|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.67
74004743|NCT02146326|147559075|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.77
74004744|NCT02146326|147559076|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.59
74004745|NCT02146326|147559077|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.64
74004746|NCT02146326|147559078|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.05
74004747|NCT02146326|147559079|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.06
74004748|NCT02146326|147559080|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.84
74004749|NCT02146326|147559081|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.14
74004750|NCT02146326|147559082|SUPERIORITY|||||||0.45|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.45
74004751|NCT03622619|147559095|OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
74004752|NCT03622619|147559096|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
74004753|NCT03622619|147559097|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
74091014|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.83|STANDARD_ERROR_OF_MEAN|3.4987|||TWO_SIDED|95.0|-13.8|0.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.1|-13.8|
73878229|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.973|TWO_SIDED|95.0|-0.83|0.801|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.801|-0.830|0.973
74004754|NCT03622619|147559098|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Burning/stinging||||||0.90
74004755|NCT03622619|147559098|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|Grittiness/foreign body sensation||||||0.30
74004756|NCT03622619|147559098|SUPERIORITY|||||||0.66||||||Dryness|Wilcoxon (Mann-Whitney)|||||||0.66
74004757|NCT03622619|147559098|SUPERIORITY|||||||0.14||||||Blurred vision|Wilcoxon (Mann-Whitney)|||||||0.14
74004758|NCT03622619|147559098|SUPERIORITY|||||||0.3||||||Overall discomfort|Wilcoxon (Mann-Whitney)|||||||0.30
74004759|NCT02181387|147559099|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
74004760|NCT02181387|147559099|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
74004761|NCT01598311|147559129|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in adjusted percentage of cured subjects was \> -10%.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-4.9|7.6||||||||7.6|-4.9|
74004762|NCT01598311|147559131|SUPERIORITY|Superiority was declared if the lower bound of the 95% CI of the adjusted difference in sustained response was \> 0.|Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-3.6|12.2||||||||12.2|-3.6|
74004763|NCT03602261|147559146|OTHER|||||||0.5536|||||||Fisher Exact|||||||0.5536
74004764|NCT03081052|147559169|EQUIVALENCE|We estimated sample size based on equivalence test of the incidence rates of a binary outcome (e.g. PGD grade 3 (PGD-3)) of two treatment groups as an illustration. Assuming the incidence rate of PGD-3 under iEPO treatment is 0.30 and acceptable margin of the equivalence is ± 0.19, we will need 200 lung transplant patients to have 80% power to detect an actual difference at α=0.05 between two treatment group under this margin.|Risk Difference (RD)|0.049||||0.019|TWO_SIDED|90.0|-0.064|0.162|||two one sided test p-value|||||0.162|-0.064|0.019
74004765|NCT03081052|147559170|NON_INFERIORITY|We estimated sample size based on equivalence test of the incidence rates of a binary outcome of two treatment groups as an illustration. Assuming the incidence rate of moderate or severe RV failure under iEPO treatment is 0.113 and acceptable margin of the equivalence is ± 0.15, we will need 224 heart failure patients to have 80% power to detect an actual difference at α=0.05 between two treatment group under this margin.|Risk Difference (RD)|0.025||||0.012|TWO_SIDED|90.0|-0.066|0.116|||two one-sided test p-value|||||0.116|-0.066|0.012
74004766|NCT03081052|147559171|OTHER||Hodges-Lehmann Location Shift|0.0||||0.747|TWO_SIDED|95.0|-3.0|3.0|||Log Rank|||||3|-3|0.747
74004767|NCT03081052|147559171|OTHER||Hodges-Lehmann Location Shift|0.0||||0.638|TWO_SIDED|95.0|-1.0|1.0|||Log Rank|||||1|-1|0.638
74004768|NCT03081052|147559173|OTHER||mean ratio|1.19||||0.453|TWO_SIDED|95.0|0.76|1.87|||log-linear regression|||||1.87|0.76|0.453
74004769|NCT03081052|147559173|OTHER||mean ratio|0.94||||0.816|TWO_SIDED|95.0|0.57|1.56|||log-linear regression|||||1.56|0.57|0.816
74004770|NCT03081052|147559174|OTHER||mean ratio|1.03||||0.864|TWO_SIDED|95.0|0.75|1.41|||log-linear regression|||||1.41|0.75|0.864
74004771|NCT03081052|147559174|OTHER||mean ratio|0.97||||0.825|TWO_SIDED|95.0|0.73|1.28|||log-linear regression|||||1.28|0.73|0.825
74004772|NCT03081052|147559175|OTHER||Odds Ratio (OR)|1.43||||0.251|TWO_SIDED|95.0|0.78|2.61|||Chi-squared|||||2.61|0.78|0.251
74004773|NCT03081052|147559175|OTHER||Odds Ratio (OR)|1.2||||0.619|TWO_SIDED|95.0|0.58|2.5|||Chi-squared|||||2.5|0.58|0.619
74004774|NCT03081052|147559177|OTHER||Odds Ratio (OR)|2.13||||0.614|TWO_SIDED|95.0|0.19|23.82|||Fisher Exact|||||23.82|0.19|0.614
74004775|NCT03081052|147559177|OTHER||Odds Ratio (OR)|0.6||||0.5424|TWO_SIDED|95.0|0.17|2.12|||Fisher Exact|||||2.12|0.17|0.5424
74004776|NCT01101477|147559192|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||The patients with at lease one episode of hypoxemia (SPaO2\<90%) during FB were analyzed by Chi-square test. P value less 0.05 means significance, 2-sided.||||0.05
74004777|NCT00720941|147559198|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority is defined as excluding a difference of greater than 25% in the hazards. The upper limit of the 95% confidence interval must be \<1.25.|Hazard Ratio (HR)|1.0466|||||TWO_SIDED|95.0|0.8982|1.2195|||||The HR is estimated by the Cox regression model using treatment stratification factors as covariates. The HR is adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase (\<=1.5xULN, \>1.5xULN).|||1.2195|0.8982|
74004778|NCT00604279|147559217|NON_INFERIORITY_OR_EQUIVALENCE|The predetermined margin for non-inferiority of paliperidone palmitate was 5.5 points|Least Square Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.48||||95.0|-5.2|0.63|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||0.63|-5.20|
74004779|NCT00604279|147559218|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.34||||95.0|-2.14|3.12|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||3.12|-2.14|
74004780|NCT00604279|147559219|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||||95.0|-0.33|0.1|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||0.10|-0.33|
74004781|NCT00604279|147559220|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.08||||95.0|-0.67|7.5|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||Statistical Analysis for Quality of sleep||7.50|-0.67|
74004782|NCT00604279|147559220|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.02||||95.0|-5.04|2.9|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||Statistical Analysis for Daytime drowsiness||2.90|-5.04|
74004783|NCT00604279|147559221|SUPERIORITY_OR_OTHER||Point estimate of relative risk|0.9||||||95.0|0.81|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.81|
74004784|NCT01072877|147559246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.49|||=|0.0001|TWO_SIDED|95.0|-3.72|-1.27|||ANCOVA|||||-1.27|-3.72|=0.0001
74004785|NCT01072877|147559246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.54|||<|0.0001|TWO_SIDED|95.0|-4.8|-2.29|||ANCOVA|||||-2.29|-4.80|<0.0001
74004786|NCT01072877|147559246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.98|-1.48|||ANCOVA|||||-1.48|-3.98|<0.0001
74004787|NCT01072877|147559246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.65|||<|0.0001|TWO_SIDED|95.0|-4.84|-2.46|||ANCOVA|||||-2.46|-4.84|<0.0001
74004788|NCT01072877|147559247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||=|0.0001|TWO_SIDED|95.0|-1.17|-0.4|||ANCOVA|||||-0.40|-1.17|=0.0001
74004789|NCT01072877|147559247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.65|-0.86|||ANCOVA|||||-0.86|-1.65|<0.0001
74004790|NCT01072877|147559247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45|||<|0.0001|TWO_SIDED|95.0|-1.85|-1.06|||ANCOVA|||||-1.06|-1.85|<0.0001
74004791|NCT01072877|147559247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-1.98|-1.23|||ANCOVA|||||-1.23|-1.98|<0.0001
74004792|NCT01072877|147559248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||=|0.0001|TWO_SIDED|95.0|-0.66|-0.23|||ANCOVA|||||-0.23|-0.66|=0.0001
74004793|NCT01072877|147559248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76|||<|0.0001|TWO_SIDED|95.0|-0.98|-0.53|||ANCOVA|||||-0.53|-0.98|<0.0001
74004794|NCT01072877|147559248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.53|||ANCOVA|||||-0.53|-0.97|<0.0001
73878230|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.355||||0.393|TWO_SIDED|95.0|-1.17|0.461|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.461|-1.170|0.393
73878231|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|-0.181||||0.663|TWO_SIDED|95.0|-0.993|0.632|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.632|-0.993|0.663
73878232|NCT03084796|147295456|SUPERIORITY||Mean Difference (Final Values)|0.174||||0.676|TWO_SIDED|95.0|-0.643|0.991|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.991|-0.643|0.676
73878233|NCT02741245|147295491|OTHER||Difference in M-estimates|-35.9|||<|0.001|TWO_SIDED|95.0|-39.9|-32.0|||Shapiro-Wilk test|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach||||-32.0|-39.9|<0.001
73878234|NCT02741245|147295491|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-14.8|||<|0.001|TWO_SIDED|95.0|-18.0|-11.6|||Shapiro-Wilk test|||||-11.6|-18.0|<0.001
73878235|NCT02741245|147295491|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-41.8|||<|0.001|TWO_SIDED|95.0|-45.8|-37.9|||Shapiro-Wilk test|||||-37.9|-45.8|<0.001
73878236|NCT02741245|147295491|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Differecne in M-estimates|-13.3|||<|0.001|TWO_SIDED|95.0|-16.6|-10.1|||Shapiro-Wilk test|||||-10.1|-16.6|<0.001
73878237|NCT00607087|147295515|SUPERIORITY_OR_OTHER|||||||0.039||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.039
74004795|NCT01072877|147559248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.68|||ANCOVA|||||-0.68|-1.11|<0.0001
74004796|NCT00719563|147559315|SUPERIORITY_OR_OTHER|||||||0.0737|||||||Wilcoxon Rank Sum|||||||0.0737
74004797|NCT00420017|147559328|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.02|TWO_SIDED|95.0|0.16|0.86|||Chi-squared|||||0.86|0.16|0.02
74004798|NCT00420017|147559329|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
73878238|NCT00607087|147295515|SUPERIORITY_OR_OTHER|||||||0.031||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025.|McNemar|||||||0.031
73878239|NCT00607087|147295516|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
73878240|NCT00607087|147295516|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
73878241|NCT00607087|147295517|SUPERIORITY_OR_OTHER|||||||0.08||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.080
73878242|NCT00607087|147295517|SUPERIORITY_OR_OTHER|||||||0.107||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.107
73878243|NCT00607087|147295518|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
74004799|NCT00420017|147559330|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.097
74004800|NCT00420017|147559331|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Chi-squared|||||||0.66
74004801|NCT04533451|147559350|SUPERIORITY|||||||0.0385|||||||Log Rank|||||||0.0385
74004802|NCT04533451|147559352|EQUIVALENCE|Relatively large sample size and groups are independent.||||||0.9829|||||||Chi-squared|||||||0.9829
74004803|NCT01776424|147559354|SUPERIORITY||Hazard Ratio (HR)|0.76||||4e-05|TWO_SIDED|95.0|0.66|0.86||Independent DSMB recommended to stop rivaroxaban/aspirin arms on 06FEB2017. At first interim analysis(\~50% events) the log-rank test statistic for one primary comparison had crossed the modified Haybittle-Peto boundary(z=4) consistently over 3 months|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.86|0.66|0.00004
74004804|NCT01776424|147559354|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1149|TWO_SIDED|95.0|0.79|1.03|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.03|0.79|0.11490
74004805|NCT01776424|147559355|SUPERIORITY||Hazard Ratio (HR)|1.7|||<|1e-05|TWO_SIDED|95.0|1.4|2.05|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||2.05|1.40|<0.00001
74004806|NCT01776424|147559355|SUPERIORITY||Hazard Ratio (HR)|1.51||||3e-05|TWO_SIDED|95.0|1.25|1.84|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.84|1.25|0.00003
74004807|NCT01776424|147559356|SUPERIORITY||Hazard Ratio (HR)|0.72||||1e-05|TWO_SIDED|95.0|0.63|0.83||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.83|0.63|0.00001
74004808|NCT01776424|147559356|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.06437|TWO_SIDED|95.0|0.77|1.01||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.01|0.77|0.06437
74004809|NCT01776424|147559357|SUPERIORITY||Hazard Ratio (HR)|0.74||||1e-05|TWO_SIDED|95.0|0.65|0.85||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.85|0.65|0.00001
74004810|NCT01776424|147559357|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.03995||95.0|0.77|0.99||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.99|0.77|0.03995
74004811|NCT01776424|147559358|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.01062|TWO_SIDED|95.0|0.71|0.96||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.96|0.71|0.01062
74004812|NCT01776424|147559358|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.66418|TWO_SIDED|95.0|0.84|1.12||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.12|0.84|0.66418
74004813|NCT00186069|147559380|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.68|TWO_SIDED|95.0|0.77|1.86|||Fisher Exact|||||1.86|0.77|0.68
74004814|NCT00186069|147559381|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
74004815|NCT00186069|147559382|SUPERIORITY_OR_OTHER|||||||0.95|||||||Fisher Exact|||||||0.95
74004816|NCT01794923|147559430|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||ANOVA|||Analysis was performed using an analysis of variance (ANOVA) model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||||0.200
74004817|NCT01794923|147559430|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|7.6||||0.23|TWO_SIDED|95.0|-4.81|19.92|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||19.92|-4.81|0.230
74004818|NCT01794923|147559430|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.4||||0.484|TWO_SIDED|95.0|-16.81|7.99|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||7.99|-16.81|0.484
74004819|NCT01794923|147559430|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.0||||0.077|TWO_SIDED|95.0|-1.32|25.25|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||25.25|-1.32|0.077
74004820|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.860
74004821|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|7.0||||0.584|TWO_SIDED|95.0|-18.3|32.38|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||32.38|-18.30|0.584
74004822|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.6||||0.838|TWO_SIDED|95.0|-22.77|28.06|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||28.06|-22.77|0.838
74004823|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.4||||0.75|TWO_SIDED|95.0|-22.81|31.61|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||31.61|-22.81|0.750
74004824|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.533
74004825|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-13.9||||0.326|TWO_SIDED|95.0|-41.81|13.95|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||13.95|-41.81|0.326
74004826|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.0||||0.945|TWO_SIDED|95.0|-26.98|28.94|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||28.94|-26.98|0.945
74004827|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.9||||0.327|TWO_SIDED|95.0|-44.85|15.03|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||15.03|-44.85|0.327
74004828|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY|||||||0.988|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.988
74004829|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.2||||0.887|TWO_SIDED|95.0|-48.31|41.81|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||41.81|-48.31|0.887
74004830|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.7||||0.907|TWO_SIDED|95.0|-47.88|42.5|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||42.50|-47.88|0.907
74004831|NCT01794923|147559431|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.982|TWO_SIDED|95.0|-48.95|47.83|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||47.83|-48.95|0.982
74004832|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.630
74004833|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.342|TWO_SIDED|95.0|-0.39|0.14|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.14|-0.39|0.342
74004834|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.6|TWO_SIDED|95.0|-0.34|0.19|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.19|-0.34|0.600
74004835|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.691|TWO_SIDED|95.0|-0.34|0.23|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.23|-0.34|0.691
74004836|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.091
74004837|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.351|TWO_SIDED|95.0|-0.44|0.16|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.16|-0.44|0.351
74004838|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.029|TWO_SIDED|95.0|-0.64|-0.04|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||-0.04|-0.64|0.029
74004839|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.238|TWO_SIDED|95.0|-0.13|0.52|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.52|-0.13|0.238
74004840|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.305
74004841|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.37|TWO_SIDED|95.0|-0.54|0.2|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.20|-0.54|0.370
74004842|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.13|TWO_SIDED|95.0|-0.66|0.09|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.09|-0.66|0.130
74004843|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.561|TWO_SIDED|95.0|-0.28|0.51|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.51|-0.28|0.561
74004844|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.209|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.209
74004845|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.277|TWO_SIDED|95.0|-0.68|0.19|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.19|-0.68|0.277
74004846|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.085|TWO_SIDED|95.0|-0.82|0.05|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.05|-0.82|0.085
74004847|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.546|TWO_SIDED|95.0|-0.32|0.61|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.61|-0.32|0.546
74004848|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.185|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.185
74004849|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.4|TWO_SIDED|95.0|-0.64|0.26|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.26|-0.64|0.400
74004850|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.067|TWO_SIDED|95.0|-0.88|0.03|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.03|-0.88|0.067
74004851|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.35|TWO_SIDED|95.0|-0.25|0.71|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.71|-0.25|0.350
74004852|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.493|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.493
74004853|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.922|TWO_SIDED|95.0|-0.53|0.48|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.48|-0.53|0.922
74004854|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.265|TWO_SIDED|95.0|-0.8|0.22|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.22|-0.80|0.265
74004855|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.342|TWO_SIDED|95.0|-0.28|0.81|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.81|-0.28|0.342
74004856|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.311|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.311
74004857|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.865|TWO_SIDED|95.0|-0.49|0.58|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.58|-0.49|0.865
74004858|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.193|TWO_SIDED|95.0|-0.89|0.18|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.18|-0.89|0.193
74004859|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.17|TWO_SIDED|95.0|-0.17|0.97|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.97|-0.17|0.170
74004860|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.383|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.383
74004861|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.802|TWO_SIDED|95.0|-0.48|0.62|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.62|-0.48|0.802
74004862|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.87|0.24|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.24|-0.87|0.260
74004863|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.199|TWO_SIDED|95.0|-0.21|0.98|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.98|-0.21|0.199
74004864|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.139|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.139
74004865|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.441|TWO_SIDED|95.0|-0.35|0.8|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.80|-0.35|0.441
74004866|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.183|TWO_SIDED|95.0|-0.96|0.18|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.18|-0.96|0.183
74004867|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.05|TWO_SIDED|95.0|0.0|1.23|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.23|-0.00|0.050
74004868|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.221|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.221
74004869|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.526|TWO_SIDED|95.0|-0.4|0.79|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.79|-0.40|0.526
74004870|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.4||||0.232|TWO_SIDED|95.0|-0.96|0.23|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.23|-0.96|0.232
74004871|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.089|TWO_SIDED|95.0|-0.08|1.19|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.19|-0.08|0.089
74004872|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.190
74004873|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.365|TWO_SIDED|95.0|-0.31|0.85|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.85|-0.31|0.365
74004874|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.295|TWO_SIDED|95.0|-0.89|0.27|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.27|-0.89|0.295
74004875|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.069|TWO_SIDED|95.0|-0.05|1.2|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.20|-0.05|0.069
74004876|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.197
74004877|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.309|TWO_SIDED|95.0|-0.29|0.92|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.92|-0.29|0.309
74004878|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.359|TWO_SIDED|95.0|-0.89|0.33|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.33|-0.89|0.359
74004879|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.072|TWO_SIDED|95.0|-0.05|1.25|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.25|-0.05|0.072
74004880|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.151|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.151
74004881|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.09|TWO_SIDED|95.0|-0.1|1.32|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.32|-0.10|0.090
74004882|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.889|TWO_SIDED|95.0|-0.76|0.66|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.66|-0.76|0.889
74004883|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.7||||0.088|TWO_SIDED|95.0|-0.1|1.42|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.42|-0.10|0.088
74004884|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.673
74004885|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.393|TWO_SIDED|95.0|-0.41|1.04|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.04|-0.41|0.393
74004886|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.887|TWO_SIDED|95.0|-0.67|0.78|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.78|-0.67|0.887
74004887|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.507|TWO_SIDED|95.0|-0.51|1.04|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.04|-0.51|0.507
74004888|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.873
74004889|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.605|TWO_SIDED|95.0|-0.58|1.0|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.00|-0.58|0.605
74004890|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.86|TWO_SIDED|95.0|-0.72|0.86|||ANOVA|||26 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.86|-0.72|0.860
74038309|NCT02667457|147629864|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
74038310|NCT02667457|147629864|OTHER|||||||0.0334||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0334
74038311|NCT02667457|147629865|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
74038312|NCT02667457|147629865|OTHER|||||||0.0301||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0301
74038313|NCT02667457|147629866|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
74038314|NCT02667457|147629866|OTHER|||||||0.0387||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0387
74038315|NCT02667457|147629867|OTHER|||||||0.0359||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0359
74038316|NCT02667457|147629867|OTHER|||||||0.0022||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0022
74038317|NCT02475850|147629872|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.245|TWO_SIDED|95.0|0.8|1.06||p\<0.05 threshold (primary outcome)|Regression, Cox|multistate model accounting for death as a semi-competing risk||||1.06|0.80|0.245
74038318|NCT02475850|147629873|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.004|TWO_SIDED|99.0|0.83|0.99||p\< 0.01 threshold (secondary outcome)|Regression, Cox|||||0.99|0.83|0.004
74004891|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.751|TWO_SIDED|95.0|-0.71|0.98|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.98|-0.71|0.751
74038319|NCT02475850|147629875|SUPERIORITY||Difference in least-squared means across|0.72|STANDARD_ERROR_OF_MEAN|0.71||0.309|TWO_SIDED|99.0|-1.1|2.54||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||2.54|-1.10|0.309
74038320|NCT02475850|147629876|SUPERIORITY||Least squares means|0.59||||0.528|TWO_SIDED|99.0|-1.8|0.93||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||0.93|-1.80|0.528
74038321|NCT02475850|147629877|SUPERIORITY||Least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.43||0.037|TWO_SIDED|99.0|-2.0|0.2||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness|Difference in least-squared means across all follow-up (repeated measures: 12 months/24 months)|||0.20|-2.00|0.037
74038322|NCT02475850|147629878|SUPERIORITY||Least squares means|-1.19|STANDARD_ERROR_OF_MEAN|0.45||0.009|TWO_SIDED|99.0|-2.36|-0.02||p\<0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||-0.02|-2.36|0.009
74038323|NCT02475850|147629879|SUPERIORITY||Least squares means|-0.07|STANDARD_ERROR_OF_MEAN|0.51||0.897|TWO_SIDED|99.0|-1.38|1.25||p \<0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness|Difference in least-squared means across all follow-up (repeated measures: 12 months, 24 months)|||1.25|-1.38|0.897
74038324|NCT01746940|147629880|SUPERIORITY_OR_OTHER|||||||0.1088||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||0.1088
74038325|NCT01746940|147629880|SUPERIORITY_OR_OTHER|||||||0.0005||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||0.0005
74038326|NCT02700919|147629895|SUPERIORITY|||||||0.012|||||||Log Rank|||Change from Baseline on Day 7||||0.012
74038327|NCT02700919|147629895|SUPERIORITY||||||<|0.001|||||||Log Rank|||Change from Baseline on Day 7||||<0.001
74038328|NCT02700919|147629895|SUPERIORITY|||||||0.102|||||||Log Rank|||Change from Baseline on Day 7||||0.102
74038329|NCT02700919|147629895|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.507|TWO_SIDED|95.0|-0.053|0.107|||Mixed Models Analysis|||Day 7||0.107|-0.053|0.507
74038330|NCT02700919|147629895|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.148|TWO_SIDED|95.0|-0.021|0.136|||Mixed Models Analysis|||Day 7||0.136|-0.021|0.148
74038331|NCT02700919|147629895|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.443|TWO_SIDED|95.0|-0.109|0.048|||Mixed Models Analysis|||Day 7||0.048|-0.109|0.443
74038332|NCT02700919|147629899|SUPERIORITY|||||||0.399|||||||Log Rank|||||||0.399
74004892|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.528|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.528
74004893|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.486|TWO_SIDED|95.0|-1.09|0.52|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.52|-1.09|0.486
74004894|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.61|TWO_SIDED|95.0|-0.6|1.02|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.02|-0.60|0.610
74004895|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.261|TWO_SIDED|95.0|-1.36|0.37|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.37|-1.36|0.261
74004896|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.943|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.943
74004897|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.733|TWO_SIDED|95.0|-0.96|0.68|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.68|-0.96|0.733
74004898|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.902|TWO_SIDED|95.0|-0.87|0.77|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.77|-0.87|0.902
74004899|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.84|TWO_SIDED|95.0|-0.97|0.79|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.79|-0.97|0.840
74004900|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.758
74004901|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.493|TWO_SIDED|95.0|-1.12|0.54|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.54|-1.12|0.493
74004902|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.974|TWO_SIDED|95.0|-0.84|0.82|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.82|-0.84|0.974
74004903|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.543|TWO_SIDED|95.0|-1.16|0.61|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.61|-1.16|0.543
74004904|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY|||||||0.238|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.238
74038333|NCT02700919|147629899|SUPERIORITY|||||||0.091|||||||Log Rank|||||||0.091
74038334|NCT02700919|147629899|SUPERIORITY|||||||0.437|||||||Log Rank|||||||0.437
74038335|NCT02700919|147629903|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.720
74038336|NCT02700919|147629903|SUPERIORITY|||||||0.298|||||||Log Rank|||||||0.298
74038337|NCT02700919|147629903|SUPERIORITY|||||||0.47|||||||Log Rank|||||||0.470
74038338|NCT00751179|147629926|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
74038339|NCT00751179|147629927|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
74038340|NCT00751179|147629929|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
74004905|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||0.106|TWO_SIDED|95.0|-1.46|0.14|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.14|-1.46|0.106
74004906|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.817|TWO_SIDED|95.0|-0.9|0.71|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.71|-0.90|0.817
74004907|NCT01794923|147559432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.197|TWO_SIDED|95.0|-1.43|0.3|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.30|-1.43|0.197
74004908|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.702|TWO_SIDED||||||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.702
74004909|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.8||||0.664|TWO_SIDED|95.0|-9.91|15.53|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||15.53|-9.91|0.664
74004910|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.0||||0.637|TWO_SIDED|95.0|-15.77|9.68|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||9.68|-15.77|0.637
74004911|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9||||0.401|TWO_SIDED|95.0|-7.85|19.57|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||19.57|-7.85|0.401
74038341|NCT00751179|147629931|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
74039854|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.016|TWO_SIDED|95.0|-0.66|-0.07|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.07|-0.66|0.0160
73878244|NCT00607087|147295518|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||<0.001
73878245|NCT00607087|147295519|SUPERIORITY_OR_OTHER|||||||0.079||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.079
73878246|NCT00607087|147295519|SUPERIORITY_OR_OTHER|||||||0.063||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.063
74004912|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.926|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.926
74004913|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.2||||0.743|TWO_SIDED|95.0|-29.51|21.1|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||21.10|-29.51|0.743
73878247|NCT00607087|147295520|SUPERIORITY_OR_OTHER|||||||0.015||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.015
73878248|NCT00607087|147295520|SUPERIORITY_OR_OTHER|||||||0.073||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.073
73878249|NCT00607087|147295521|SUPERIORITY_OR_OTHER|||||||0.017||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.017
73878250|NCT00607087|147295521|SUPERIORITY_OR_OTHER|||||||0.032||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.032
74004914|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8||||0.952|TWO_SIDED|95.0|-24.55|26.08|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||26.08|-24.55|0.952
74004915|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.0||||0.719|TWO_SIDED|95.0|-32.25|22.3|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||22.30|-32.25|0.719
74004916|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.284
74004917|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-19.0||||0.171|TWO_SIDED|95.0|-46.21|8.28|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||8.28|-46.21|0.171
74004918|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.2||||0.875|TWO_SIDED|95.0|-25.08|29.42|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||29.42|-25.08|0.875
74004919|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.1||||0.157|TWO_SIDED|95.0|-50.5|8.23|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||8.23|-50.50|0.157
74004920|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.699|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.699
74004921|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.8||||0.433|TWO_SIDED|95.0|-62.58|26.9|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||26.90|-62.58|0.433
73878251|NCT00607087|147295522|SUPERIORITY_OR_OTHER|||||||0.009||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.009
74004922|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0||||0.966|TWO_SIDED|95.0|-45.73|43.78|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||43.78|-45.73|0.966
74004923|NCT01794923|147559433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-16.9||||0.491|TWO_SIDED|95.0|-65.08|31.36|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||31.36|-65.08|0.491
74004924|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.219
74004925|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.214|TWO_SIDED|95.0|-0.37|0.08|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.08|-0.37|0.214
74004926|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.555|TWO_SIDED|95.0|-0.16|0.29|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.29|-0.16|0.555
74004927|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.09|TWO_SIDED|95.0|-0.45|0.03|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.03|-0.45|0.090
74038342|NCT01517412|147629953|NON_INFERIORITY_OR_EQUIVALENCE|A step-down procedure was used to control the type I error: non-inferiority of lixisenatide prior to the main meal of the day versus lixisenatide prior to breakfast was tested first. If non-inferiority was established, then a test of superiority of lixisenatide prior to the main meal of the day over lixisenatide prior to breakfast was to be performed. The non-inferiority was assessed using upper bound of 2-sided 95% CI at a level of ≤0.4%.|Least square (LS) mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|95.0|-0.067|0.242|||||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate.||0.242|-0.067|
74004928|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.161|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.161
74004929|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.056|TWO_SIDED|95.0|-0.55|0.01|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.01|-0.55|0.056
74004930|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.395|TWO_SIDED|95.0|-0.4|0.16|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.16|-0.40|0.395
74004931|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.324|TWO_SIDED|95.0|-0.45|0.15|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.15|-0.45|0.324
74004932|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.246|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.246
74004933|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.094|TWO_SIDED|95.0|-0.68|0.05|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.05|-0.68|0.094
74004934|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.491|TWO_SIDED|95.0|-0.5|0.24|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.24|-0.50|0.491
74004935|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.359|TWO_SIDED|95.0|-0.58|0.21|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.21|-0.58|0.359
74004936|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.294
74004937|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.136|TWO_SIDED|95.0|-0.74|0.1|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.10|-0.74|0.136
74004938|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.293|TWO_SIDED|95.0|-0.65|0.2|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.20|-0.65|0.293
74004939|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.682|TWO_SIDED|95.0|-0.55|0.36|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.36|-0.55|0.682
74004940|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.747|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.747
74038343|NCT01517412|147629953|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.079||0.2664|TWO_SIDED|||||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate. A step-down procedure was used to control the type I error. The superiority was assessed by comparing the p-value at significance level = 0.05.||||0.2664
74038344|NCT01253187|147629963|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.03||||||90.0|98.86|113.72||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.72|98.86|
74004941|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.592|TWO_SIDED|95.0|-0.6|0.34|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.34|-0.60|0.592
74004942|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.473|TWO_SIDED|95.0|-0.64|0.3|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.30|-0.64|0.473
74004943|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.866|TWO_SIDED|95.0|-0.46|0.55|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.55|-0.46|0.866
74004944|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.776|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.776
74004945|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.761|TWO_SIDED|95.0|-0.59|0.43|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.43|-0.59|0.761
74004946|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.477|TWO_SIDED|95.0|-0.69|0.33|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.33|-0.69|0.477
74004947|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.705|TWO_SIDED|95.0|-0.44|0.65|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.65|-0.44|0.705
74004948|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.600
74004949|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.931|TWO_SIDED|95.0|-0.52|0.56|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.56|-0.52|0.931
74004950|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.381|TWO_SIDED|95.0|-0.78|0.3|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.30|-0.78|0.381
74004951|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.371|TWO_SIDED|95.0|-0.32|0.85|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.85|-0.32|0.371
74004952|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.670
74004953|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.941|TWO_SIDED|95.0|-0.54|0.58|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.58|-0.54|0.941
74004954|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.437|TWO_SIDED|95.0|-0.78|0.34|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.34|-0.78|0.437
74004955|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.429|TWO_SIDED|95.0|-0.36|0.84|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.84|-0.36|0.429
74004956|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.484
74004957|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.504|TWO_SIDED|95.0|-0.38|0.78|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.78|-0.38|0.504
74004958|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.528|TWO_SIDED|95.0|-0.77|0.4|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.40|-0.77|0.528
74004959|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.229|TWO_SIDED|95.0|-0.24|1.01|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.01|-0.24|0.229
74004960|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.536|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.536
74004961|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.728|TWO_SIDED|95.0|-0.49|0.7|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.70|-0.49|0.728
74004962|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.414|TWO_SIDED|95.0|-0.84|0.35|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.35|-0.84|0.414
74004963|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.28|TWO_SIDED|95.0|-0.29|0.99|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.99|-0.29|0.280
74004964|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.402|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.402
74004965|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.513|TWO_SIDED|95.0|-0.41|0.81|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.81|-0.41|0.513
74004966|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.424|TWO_SIDED|95.0|-0.86|0.36|||ANOVA|||11 hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.36|-0.86|0.424
74004967|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.178|TWO_SIDED|95.0|-0.21|1.1|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.10|-0.21|0.178
74004968|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.442|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.442
74004969|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.357|TWO_SIDED|95.0|-0.33|0.91|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.91|-0.33|0.357
74004970|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.675|TWO_SIDED|95.0|-0.75|0.49|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.49|-0.75|0.675
74004971|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.215|TWO_SIDED|95.0|-0.25|1.09|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.09|-0.25|0.215
74004972|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.643|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.643
74004973|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.466|TWO_SIDED|95.0|-0.46|0.99|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.99|-0.46|0.466
74004974|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.818|TWO_SIDED|95.0|-0.81|0.64|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.64|-0.81|0.818
74004975|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.373|TWO_SIDED|95.0|-0.43|1.13|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.13|-0.43|0.373
74004976|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.984|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.984
74004977|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.874|TWO_SIDED|95.0|-0.79|0.68|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.68|-0.79|0.874
74004978|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.99|TWO_SIDED|95.0|-0.73|0.74|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.74|-0.73|0.990
74004979|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.875|TWO_SIDED|95.0|-0.85|0.73|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.73|-0.85|0.875
74004980|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.841|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.841
74004981|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.58|TWO_SIDED|95.0|-1.01|0.57|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.57|-1.01|0.580
74004982|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.958|TWO_SIDED|95.0|-0.81|0.77|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.77|-0.81|0.958
74004983|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.643|TWO_SIDED|95.0|-1.05|0.65|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.65|-1.05|0.643
74004984|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.299
74004985|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.5||||0.23|TWO_SIDED|95.0|-1.26|0.31|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.31|-1.26|0.230
74004986|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.694|TWO_SIDED|95.0|-0.63|0.94|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.94|-0.63|0.694
74004987|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.14|TWO_SIDED|95.0|-1.48|0.21|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.21|-1.48|0.140
74004988|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.503|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.503
74004989|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.262|TWO_SIDED|95.0|-1.28|0.35|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.35|-1.28|0.262
74004990|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.871|TWO_SIDED|95.0|-0.88|0.75|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.75|-0.88|0.871
74004991|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.373|TWO_SIDED|95.0|-1.27|0.48|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.48|-1.27|0.373
74004992|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.413
74004993|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.317|TWO_SIDED|95.0|-1.22|0.4|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.40|-1.22|0.317
74004994|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.708|TWO_SIDED|95.0|-0.66|0.97|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.97|-0.66|0.708
74004995|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.202|TWO_SIDED|95.0|-1.44|0.31|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.31|-1.44|0.202
74004996|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.190
74004997|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||0.094|TWO_SIDED|95.0|-1.44|0.11|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.11|-1.44|0.094
74004998|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.96|TWO_SIDED|95.0|-0.8|0.76|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.76|-0.80|0.960
74004999|NCT01794923|147559434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.132|TWO_SIDED|95.0|-1.48|0.2|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.20|-1.48|0.132
74005000|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.163|TWO_SIDED||||||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.163
74005001|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6||||0.162|TWO_SIDED|95.0|-1.86|11.02|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||11.02|-1.86|0.162
74005002|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.9||||0.559|TWO_SIDED|95.0|-8.42|4.57|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||4.57|-8.42|0.559
74005003|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.5||||0.066|TWO_SIDED|95.0|-0.44|13.45|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||13.45|-0.44|0.066
74005004|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.957|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.957
74005005|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.1||||0.864|TWO_SIDED|95.0|-11.2|13.33|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||13.33|-11.20|0.864
74005006|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9||||0.883|TWO_SIDED|95.0|-13.3|11.45|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||11.45|-13.30|0.883
74005007|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0||||0.767|TWO_SIDED|95.0|-11.24|15.22|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||15.22|-11.24|0.767
74005008|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.243|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.243
74005009|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.2||||0.176|TWO_SIDED|95.0|-20.12|3.7|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||3.70|-20.12|0.176
74005010|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0||||0.741|TWO_SIDED|95.0|-10.0|14.03|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||14.03|-10.00|0.741
74005011|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.2||||0.118|TWO_SIDED|95.0|-23.07|2.62|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||2.62|-23.07|0.118
74005012|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.920
74005013|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.2||||0.685|TWO_SIDED|95.0|-24.64|16.23|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||16.23|-24.64|0.685
74005014|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.4||||0.892|TWO_SIDED|95.0|-22.04|19.19|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||19.19|-22.04|0.892
74005015|NCT01794923|147559435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.8||||0.804|TWO_SIDED|95.0|-24.82|19.25|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||19.25|-24.82|0.804
74038345|NCT01253187|147629964|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|103.47||||||90.0|99.16|107.98||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||107.98|99.16|
74005016|NCT01794923|147559436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533|TWO_SIDED||||||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||||0.533
74005017|NCT01794923|147559436|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.5||||0.266|TWO_SIDED|95.0|-0.38|1.38|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.38|-0.38|0.266
74005018|NCT01794923|147559436|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.73|TWO_SIDED|95.0|-0.74|1.05|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.05|-0.74|0.730
74005019|NCT01794923|147559436|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.479|TWO_SIDED|95.0|-0.61|1.3|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.30|-0.61|0.479
74005020|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.189
74005021|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.389|TWO_SIDED|95.0|-0.17|0.07|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.07|-0.17|0.389
74005022|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.273|TWO_SIDED|95.0|-0.05|0.19|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.05|0.273
74005023|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.069|TWO_SIDED|95.0|-0.25|0.01|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.01|-0.25|0.069
74005024|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.716|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.716
74005025|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.735|TWO_SIDED|95.0|-0.15|0.11|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.15|0.735
74005026|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.414|TWO_SIDED|95.0|-0.19|0.08|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.08|-0.19|0.414
74005027|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.652|TWO_SIDED|95.0|-0.11|0.17|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.17|-0.11|0.652
74005028|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.622
74005029|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.83|TWO_SIDED|95.0|-0.17|0.21|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.21|-0.17|0.830
74005030|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.442|TWO_SIDED|95.0|-0.26|0.11|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.26|0.442
74005031|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.358|TWO_SIDED|95.0|-0.11|0.29|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.29|-0.11|0.358
74005032|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.714|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.714
74005033|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.683|TWO_SIDED|95.0|-0.29|0.19|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.29|0.683
74005034|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.413|TWO_SIDED|95.0|-0.34|0.14|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.14|-0.34|0.413
74005035|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.699|TWO_SIDED|95.0|-0.21|0.31|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.31|-0.21|0.699
74005036|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.244
74005037|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.21|0.26|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.21|0.833
74005038|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.156|TWO_SIDED|95.0|-0.41|0.07|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.07|-0.41|0.156
74038346|NCT01253187|147629965|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|105.24||||||90.0|97.3|113.83||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.83|97.30|
74038347|NCT01253187|147629966|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.48||||||90.0|97.28|103.79||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.79|97.28|
74038348|NCT01253187|147629967|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|91.24|109.34||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||109.34|91.24|
74038349|NCT01253187|147629968|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.16||||||90.0|93.95|102.57||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||102.57|93.95|
74039855|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0003|TWO_SIDED|95.0|-0.85|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-0.85|0.0003
74005039|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.128|TWO_SIDED|95.0|-0.06|0.46|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.46|-0.06|0.128
74005040|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.359
74005041|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.278|TWO_SIDED|95.0|-0.12|0.43|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.43|-0.12|0.278
74005042|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.699|TWO_SIDED|95.0|-0.33|0.22|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.22|-0.33|0.699
74005043|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.172|TWO_SIDED|95.0|-0.09|0.5|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.50|-0.09|0.172
74005044|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.515|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.515
74005045|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.527|TWO_SIDED|95.0|-0.19|0.37|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.37|-0.19|0.527
74005046|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.545|TWO_SIDED|95.0|-0.37|0.19|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.37|0.545
74005047|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.25|TWO_SIDED|95.0|-0.12|0.47|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.47|-0.12|0.250
74005048|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.568|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.568
74005049|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.381|TWO_SIDED|95.0|-0.16|0.41|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.41|-0.16|0.381
74005050|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.863|TWO_SIDED|95.0|-0.31|0.26|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.31|0.863
74005051|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.33|TWO_SIDED|95.0|-0.16|0.46|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.46|-0.16|0.330
74005052|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.167|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.167
74005053|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.165|TWO_SIDED|95.0|-0.09|0.5|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.50|-0.09|0.165
74005054|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.564|TWO_SIDED|95.0|-0.39|0.21|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.21|-0.39|0.564
74005055|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.068|TWO_SIDED|95.0|-0.02|0.62|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.62|-0.02|0.068
74005056|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.131
74005057|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.119|TWO_SIDED|95.0|-0.06|0.56|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.56|-0.06|0.119
74039856|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.17||0.0091|TWO_SIDED|95.0|-0.77|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.77|0.0091
74005058|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.616|TWO_SIDED|95.0|-0.39|0.23|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.23|-0.39|0.616
74005059|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.056|TWO_SIDED|95.0|-0.01|0.66|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.66|-0.01|0.056
74005060|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.255|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.255
74005061|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.144|TWO_SIDED|95.0|-0.08|0.57|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.57|-0.08|0.144
74005062|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.935|TWO_SIDED|95.0|-0.34|0.31|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.31|-0.34|0.935
74005063|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.153|TWO_SIDED|95.0|-0.1|0.61|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.61|-0.10|0.153
74005064|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.128
74005065|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.067|TWO_SIDED|95.0|-0.02|0.63|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.63|-0.02|0.067
74005066|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.999|TWO_SIDED|95.0|-0.33|0.33|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.33|-0.33|0.999
74005067|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.088|TWO_SIDED|95.0|-0.05|0.66|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.66|-0.05|0.088
74005068|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.195|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.195
74005069|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.175|TWO_SIDED|95.0|-0.12|0.67|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.67|-0.12|0.175
74005070|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.61|TWO_SIDED|95.0|-0.5|0.3|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.30|-0.50|0.610
74005071|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.083|TWO_SIDED|95.0|-0.05|0.81|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.81|-0.05|0.083
74005072|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.884|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.884
74005073|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.43|0.35|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.35|-0.43|0.833
74005074|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.62|TWO_SIDED|95.0|-0.49|0.29|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.29|-0.49|0.620
74005075|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.788|TWO_SIDED|95.0|-0.36|0.48|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.48|-0.36|0.788
74005076|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.755|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.755
74005077|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.787|TWO_SIDED|95.0|-0.45|0.34|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.34|-0.45|0.787
74005078|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.455|TWO_SIDED|95.0|-0.56|0.25|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.25|-0.56|0.455
74005079|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.654|TWO_SIDED|95.0|-0.33|0.53|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.53|-0.33|0.654
74005080|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.370
74005081|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.472|TWO_SIDED|95.0|-0.51|0.24|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.24|-0.51|0.472
74005082|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.427|TWO_SIDED|95.0|-0.23|0.53|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.53|-0.23|0.427
74005083|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.159|TWO_SIDED|95.0|-0.69|0.11|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.69|0.159
74005084|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.480
74005085|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.238|TWO_SIDED|95.0|-0.59|0.15|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.15|-0.59|0.238
74039857|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.90|0.0007
74005086|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.794|TWO_SIDED|95.0|-0.42|0.32|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.32|-0.42|0.794
74005087|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.395|TWO_SIDED|95.0|-0.57|0.23|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.23|-0.57|0.395
74005088|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.400
74005089|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.176|TWO_SIDED|95.0|-0.61|0.11|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.61|0.176
74005090|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.573|TWO_SIDED|95.0|-0.47|0.26|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.47|0.573
74005091|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.466|TWO_SIDED|95.0|-0.53|0.24|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.24|-0.53|0.466
74005092|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.092
74005093|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.086|TWO_SIDED|95.0|-0.67|0.04|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.04|-0.67|0.086
74005094|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.616|TWO_SIDED|95.0|-0.27|0.45|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.45|-0.27|0.616
74005095|NCT01794923|147559437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.04|TWO_SIDED|95.0|-0.79|-0.02|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||-0.02|-0.79|0.040
74091015|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.24|STANDARD_ERROR_OF_MEAN|3.6922|||TWO_SIDED|95.0|-12.6|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-12.6|
74005096|NCT01794923|147559438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.751|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||||0.751
74005097|NCT01794923|147559438|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|0.0||||0.696|TWO_SIDED|95.0|-0.28|0.2|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.20|-0.28|0.696
74005098|NCT01794923|147559438|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|0.0||||0.76|TWO_SIDED|95.0|-0.21|0.29|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.29|-0.21|0.760
74005099|NCT01794923|147559438|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|-0.1||||0.463|TWO_SIDED|95.0|-0.36|0.16|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.16|-0.36|0.463
74005100|NCT03318809|147559452|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.24|||||TWO_SIDED|90.0|0.73|2.1|||||The ratio and confidence interval (CI) are based on natural log scale data converted back to the original scale.|||2.10|0.73|
74005101|NCT03318809|147559453|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.41|||||TWO_SIDED|90.0|0.88|2.27|||||The ratio and CI are based on natural log scale data converted back to the original scale.|||2.27|0.88|
74005102|NCT03318809|147559456|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.24|||||TWO_SIDED|90.0|0.73|2.1|||||The ratio and CI are based on natural log scale data converted back to the original scale.|||2.10|0.73|
74005103|NCT00752622|147559476|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to evaluation Week 10.||||<.0001
74005104|NCT00752622|147559476|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 30 of the Observational Phase.||||<.0001
74005105|NCT00752622|147559476|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 54 of the Observational Phase.||||<.0001
74005106|NCT03291587|147559513|SUPERIORITY|With 418 analyzable participants across 13 clinics per group, we have 80% power to detect a group difference in primary outcome (7-day abstinence). This assumes control abstinence rate will be 10% versus 20% intervention rate using a 2-sided Z-test for proportions with alpha=0.05 (2-sided). To account for the clustering we used an intra-class correlation value of 0.03. We plan to enroll 1114-1300 patients (or approximately 42-50 per site) to conservatively allow for 25%- 35.5% loss to follow-up.|Odds Ratio (OR)|0.967||||0.865|TWO_SIDED|96.0|0.652|1.433|||Mixed Models Analysis|||A generalized estimating equation marginal model was used in an intent-to-treat analysis to predict the 7-day tobacco use binary outcome. A binomial distribution with logit link was specified with group, time, and the interaction of group by time included as covariates while allowing intercept and time to vary by participants within site with an exchangeable working correlation matrix designation.||1.433|0.652|0.865
74005107|NCT02197767|147559517|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||0.072
74005108|NCT02197767|147559518|SUPERIORITY|||||||0.068|||||||t-test, 2 sided|||||||0.068
74005109|NCT00267631|147559538|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Chi-squared|||||||.026
74005110|NCT00504881|147559542|SUPERIORITY_OR_OTHER||Percent Reduction over Placebo|7.3|||=|0.125|TWO_SIDED|95.0|-2.2|15.9|||ANCOVA|||ANCOVA on log-transformed partial seizure frequency per week over the treatment period, with log-transformed baseline seizure frequency per week as covariate, and including terms for treatment and stratification factors.||15.9|-2.2|=0.125
74005111|NCT02425644|147559597|SUPERIORITY||Rate ratio|0.695||||0.0003|TWO_SIDED|99.0|0.536|0.902|||Negative binomial regression model|||||0.902|0.536|0.0003
74005112|NCT02425644|147559598|SUPERIORITY||Mean Difference (Final Values)|-3.57||||0.0019|TWO_SIDED|95.0|-5.83|-1.32|||Mixed Models Analysis|||||-1.32|-5.83|0.0019
74005113|NCT02425644|147559599|SUPERIORITY||Rate Ratio|0.444|||<|0.0001|TWO_SIDED|95.0|0.364|0.542|||Negative binomial regression model|||||0.542|0.364|<.0001
74005114|NCT02425644|147559600|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.2939|TWO_SIDED|95.0|0.58|1.18|||Log Rank|||||1.18|0.58|0.2939
74005115|NCT02425644|147559601|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.372|TWO_SIDED|95.0|0.57|1.24|||Log Rank|||||1.24|0.57|0.3720
74005116|NCT00567268|147559631|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.004|||||||Fisher Exact|||"The risk factor tested was age. The null hypothesis was that there was no association between the age and the number of responders to the treatment with gabapentin."||||=0.004
74005117|NCT00567268|147559632|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.003|||||||Fisher Exact|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||=0.003
74005118|NCT00567268|147559632|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.003|||||||Cochran-Armitage|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||=0.003
74005119|NCT00567268|147559633|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no difference between \<65 years and \>=65 years in the number of participants who responded to the treatment with gabapentin."||||<0.001
74005120|NCT00567268|147559634|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no association between the age and the number of participants who responded to the treatment with gabapentin."||||<0.001
74005121|NCT00567268|147559634|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was age. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of age categories."||||<0.001
74005122|NCT00567268|147559635|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.008|||||||Chi-squared|||"The factor tested was severity of partial epileptic seizure . The null hypothesis was that there was no association between the degree of severity of partial epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."||||=0.008
74005123|NCT00567268|147559635|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.002|||||||Cochran-Armitage|||"The factor tested was severity of partial epileptic seizure. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across the degree of severity of partial epileptic seizure (mild, moderate, and severe)."||||=0.002
74005124|NCT00567268|147559636|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.018|||||||Chi-squared|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."||||=0.018
74005125|NCT00567268|147559637|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."||||<0.001
74005126|NCT00567268|147559637|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||<0.001
74005127|NCT00567268|147559638|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.025|||||||Cochran-Armitage|||"The factor tested was baseline creatinine clearance. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the baseline creatinine clearance."||||=0.025
74005128|NCT00567268|147559639|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.043|||||||Chi-squared|||"The factor tested was non-drug therapy. The null hypothesis was that there was no difference between the non-drug therapy and the number of participants who responded to the treatment with gabapentin."||||=0.043
74005129|NCT02525861|147559670|OTHER||Geometric Mean Ratio|5.398|||<|0.001|||||||Mixed-effects model|||Statistical analysis was collected and assessed based on A1P1 Levels at baseline and On-treatment BAL visit.||||<0.001
74005130|NCT02525861|147559671|OTHER||Geometric Mean Ratio|2.259|||<|0.001|||||||mixed-effects model|||Statistical analysis was collected and assessed based on functional A1P1 Levels at baseline and On-treatment BAL visit.||||<0.001
74005131|NCT04796896|147559695|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if:~The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|1.224|||||TWO_SIDED|95.0|1.061|1.413||||||||1.413|1.061|
74005132|NCT04796896|147559696|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|0.995|||||TWO_SIDED|95.0|0.87|1.139||||||||1.139|0.870|
74005133|NCT04796896|147559696|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|1.257|||||TWO_SIDED|95.0|1.101|1.434||||||||1.434|1.101|
74005134|NCT04796896|147559697|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|-0.3|||||TWO_SIDED|95.0|-2.2|1.6||||||||1.6|-2.2|
74005135|NCT04796896|147559698|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|-0.4|||||TWO_SIDED|95.0|-2.5|1.5||||||||1.5|-2.5|
74005136|NCT04796896|147559698|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-0.8|2.4||||||||2.4|-0.8|
74005137|NCT04796896|147559699|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|3.897|||||TWO_SIDED|95.0|3.158|4.808||||||||4.808|3.158|
74005138|NCT04796896|147559699|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|3.982|||||TWO_SIDED|95.0|3.404|4.657||||||||4.657|3.404|
74005139|NCT04796896|147559701|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-4.4|2.4||||||||2.4|-4.4|
74005140|NCT04796896|147559701|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-2.2|2.4||||||||2.4|-2.2|
74005141|NCT04796896|147559710|OTHER|The 95% confidence interval (CI) of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.706|||||TWO_SIDED|95.0|0.325|0.873|||||Vaccine efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.873|0.325|
74005142|NCT04796896|147559710|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.409|||||TWO_SIDED|95.0|0.287|0.509|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.509|0.287|
74005143|NCT04796896|147559710|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.324|||||TWO_SIDED|95.0|0.127|0.474|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.474|0.127|
74005144|NCT04796896|147559711|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.683|||||TWO_SIDED|95.0|0.151|0.882|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.882|0.151|
74005145|NCT04796896|147559711|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.281|||||TWO_SIDED|95.0|-0.007|0.48|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.480|-0.007|
74005146|NCT04796896|147559711|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|-0.068|||||TWO_SIDED|95.0|-0.832|0.352|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.352|-0.832|
74005147|NCT04796896|147559712|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.76|||||TWO_SIDED|95.0|-0.416|0.965|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.965|-0.416|
74005148|NCT04796896|147559712|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.466|||||TWO_SIDED|95.0|0.328|0.574|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.574|0.328|
74005149|NCT04796896|147559712|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.432|||||TWO_SIDED|95.0|0.232|0.576|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.576|0.232|
74005150|NCT04356183|147559714|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
74005151|NCT04356183|147559715|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
74038350|NCT01253187|147629969|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.28||||||90.0|93.15|107.95||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||107.95|93.15|
74038351|NCT01253187|147629970|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|95.38|104.58||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.58|95.38|
74005152|NCT04356183|147559716|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
74005153|NCT01177787|147559718|OTHER||Mean Difference (Final Values)|-0.669|STANDARD_DEVIATION|0.03||0.503|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.503
74005154|NCT00402363|147559729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.263|TWO_SIDED|95.0|0.9|1.46|||Regression, Cox|||||1.46|0.90|0.263
74005155|NCT00402363|147559730|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.089|TWO_SIDED|95.0|0.92|2.92|||Log Rank|||||2.92|0.92|0.089
74005156|NCT00402363|147559730|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.081|TWO_SIDED|95.0|0.98|1.52|||Regression, Cox|||||1.52|0.98|0.081
74005157|NCT00402363|147559731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.213|TWO_SIDED|95.0|0.91|1.49|||Regression, Cox|||||1.49|0.91|0.213
74005158|NCT00402363|147559731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.171|TWO_SIDED|95.0|0.83|2.69|||Log Rank|||||2.69|0.83|0.171
74005159|NCT00402363|147559732|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.082|TWO_SIDED|95.0|0.98|1.53|||Regression, Cox|||||1.53|0.98|0.082
74005160|NCT00402363|147559733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.331|TWO_SIDED|95.0|0.89|1.4|||Regression, Cox|||||1.40|0.89|0.331
74005161|NCT00402363|147559733|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.297|TWO_SIDED|95.0|0.79|2.11|||Log Rank|||||2.11|0.79|0.297
74005162|NCT00402363|147559734|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.168|TWO_SIDED|95.0|0.94|1.42|||Regression, Cox|||||1.42|0.94|0.168
74005163|NCT00402363|147559735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.27|TWO_SIDED|95.0|0.9|1.43|||Regression, Cox|||||1.43|0.90|0.270
74005164|NCT00402363|147559735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.486|TWO_SIDED|95.0|0.73|1.95|||Log Rank|||||1.95|0.73|0.486
74005165|NCT00402363|147559736|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.167|TWO_SIDED|95.0|0.94|1.42|||Regression, Cox|||||1.42|0.94|0.167
74005166|NCT00402363|147559737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.565|TWO_SIDED|95.0|0.81|1.47|||Regression, Cox|||||1.47|0.81|0.565
74005167|NCT00402363|147559737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.68||||0.103|TWO_SIDED|95.0|0.89|3.15|||Log Rank|||||3.15|0.89|0.103
74005168|NCT00402363|147559738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.185|TWO_SIDED|95.0|0.92|1.56|||Regression, Cox|||||1.56|0.92|0.185
74005169|NCT00402363|147559739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.461|TWO_SIDED|95.0|0.83|1.51|||Regression, Cox|||||1.51|0.83|0.461
74005170|NCT00402363|147559739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.206|TWO_SIDED|95.0|0.79|2.86|||Log Rank|||||2.86|0.79|0.206
74005171|NCT00402363|147559740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.188|TWO_SIDED|95.0|0.92|1.57|||Regression, Cox|||||1.57|0.92|0.188
74005172|NCT00402363|147559741|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.07||||0.29|TWO_SIDED|95.0|-0.09|2.08|||non-parametric ANCOVA|||||2.08|-0.09|0.290
74005173|NCT00402363|147559741|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.063||||0.479|TWO_SIDED|95.0|-0.08|2.02|||Wilcoxon (Mann-Whitney)|||||2.02|-0.08|0.479
74005174|NCT00402363|147559741|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.039||||0.218|TWO_SIDED|95.0|-0.06|1.49|||non-parametric ANCOVA|||||1.49|-0.06|0.218
74005175|NCT00402363|147559742|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.321||||0.218|TWO_SIDED|95.0|-0.18|2.21|||non-parametric ANCOVA|||||2.21|-0.18|0.218
74005176|NCT00402363|147559742|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.216||||0.188|TWO_SIDED|95.0|-0.14|3.14|||Wilcoxon (Mann-Whitney)|||||3.14|-0.14|0.188
74005177|NCT00402363|147559742|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.181||||0.097|TWO_SIDED|95.0|-0.1|2.1|||non-parametric ANCOVA|||||2.10|-0.10|0.097
74038352|NCT01253187|147629972|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.3||||||90.0|97.65|103.02||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|32 volunteers qualified for statistical analysis of BE whereas all 34 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.02|97.65|
74038353|NCT01956240|147629988|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.51|STANDARD_DEVIATION|1.9|<|0.05|TWO_SIDED|95.0|||||ANOVA|A 1-way repeated measures ANOVA was used to assess for possible differences among evaluations in each group separately for pectoralis minor length.||||||<0.05
74005178|NCT00402363|147559743|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.242||||0.239|TWO_SIDED|95.0|-0.19|2.17|||non-parametric ANCOVA|||||2.17|-0.19|0.239
74005179|NCT00402363|147559743|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.249||||0.152|TWO_SIDED|95.0|-0.09|4.31|||Wilcoxon (Mann-Whitney)|||||4.31|-0.09|0.152
74005180|NCT00402363|147559743|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.2||||0.094|TWO_SIDED|95.0|-0.08|2.11|||non-parametric ANCOVA|||||2.11|-0.08|0.094
74005181|NCT05193500|147559801|OTHER|||||||0.085||||||a priori threshold for statistical significance is 0.05|t-test, 2 sided|one-sample t-test, compared to 0.5 (chance)||||||0.085
74005182|NCT05193500|147559801|OTHER|||||||0.049||||||a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.049
74005183|NCT05193500|147559802|OTHER|||||||0.015||||||a priori threshold for statistical significance = 0.05|t-test, 2 sided|||||||0.015
74005184|NCT02604433|147559814|SUPERIORITY||Odds Ratio (OR)|5.62|||<|0.0001|TWO_SIDED|95.0|2.17|14.53||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.||14.53|2.17|<0.0001
74038354|NCT01956240|147629989|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.0|||>|0.05|TWO_SIDED|95.0|||||ANOVA|Separate 2-way repeated measures ANOVAs were used to test for interactions of angle x evaluation (1,2,3) and for main effects of evaluation.||||||>0.05
74005185|NCT02604433|147559814|SUPERIORITY||Difference in Percentages|16.5|||||TWO_SIDED|95.0|10.0|23.1|||||Luspatercept - Placebo|||23.1|10.0|
74005186|NCT02604433|147559814|SUPERIORITY||Common Risk Difference|16.5||||||95.0|9.9|23.1|||||Luspatercept - Placebo|||23.1|9.9|
74005187|NCT02604433|147559815|SUPERIORITY||Odds Ratio (OR)|6.44|||<|0.0001|TWO_SIDED|95.0|2.27|18.26||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% CIs, and p-value were estimated from the CMH test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate for outcomes 2-4, the testing procedure was implemented strictly in order: the test for this outcome was only conducted when there was evidence showing that erythroid response was achieved in the luspatercept group from Week 13 to Week 24 (primary endpoint).||18.26|2.27|<0.0001
74005188|NCT02604433|147559816|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0402|TWO_SIDED|95.0|0.96|18.79||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and 33% hematological improvement was achieved in the luspatercept group in outcome 2.||18.79|0.96|0.0402
74005189|NCT02604433|147559817|SUPERIORITY||Odds Ratio (OR)|11.92||||0.0017|TWO_SIDED|95.0|1.65|86.29||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and achievement of objective in the luspatercept group in outcomes 2+3.||86.29|1.65|0.0017
74005190|NCT02604433|147559818|SUPERIORITY||LSM Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.76|-0.93||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline transfusion burden as covariates.|luspatercept - placebo|Change from baseline at Week 48 LSM = least squares mean||-0.93|-1.76|<0.0001
74005191|NCT02604433|147559819|SUPERIORITY||LS Mean of Difference|0.2||||0.7598|TWO_SIDED|95.0|-1.1|1.51||Significance level of 0.050 for 2-sided tests.|ANCOVA||luspatercept - placebo|Change from baseline at Week 48 P-value ANCOVA model with geographical regions defined at randomization and baseline LIC as covariates. LS = least square||1.51|-1.10|0.7598
74005192|NCT02604433|147559820|SUPERIORITY||LS Mean of Difference|-68.0||||0.2552|TWO_SIDED|95.0|-185.8|49.7||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferasirox: Change from baseline at Week 48 LS = least squares||49.7|-185.8|0.2552
74005193|NCT02604433|147559820|SUPERIORITY||LS Mean of Difference|-76.4||||0.7746|TWO_SIDED|95.0|-612.9|460.1||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferiprone: Change from baseline at Week 48 LS = least squares||460.1|-612.9|0.7746
74005194|NCT02604433|147559820|SUPERIORITY||LS Mean of Difference|-147.3||||0.5186|TWO_SIDED|95.0|-673.1|378.5||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferoxamine Mesilate / Deferoxamine: Change from baseline at Week 48 LS = least squares||378.5|-673.1|0.5186
74005195|NCT02604433|147559821|SUPERIORITY||LS Mean of Difference|-342.59|||<|0.0001|TWO_SIDED|95.0|-498.3|-186.87||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates based on an ANCOVA model with geographical regions defined at randomization and baseline serum ferritin as covariates.|luspatercept - placebo|Change from baseline at Week 48 LS = least squares||-186.87|-498.30|<0.0001
74005196|NCT02604433|147559822|SUPERIORITY||LS Mean of Difference|0.0||||0.9201|TWO_SIDED|95.0|-0.01|0.01||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Total Hip Bone Mineral Density: Change from baseline at Week 48 LS = least squares||0.01|-0.01|0.9201
74005197|NCT02604433|147559822|SUPERIORITY||LS Mean of Difference|-0.01||||0.462|TWO_SIDED|95.0|-0.02|0.01||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Lumbar Spine Bone Mineral Density: Change from baseline at Week 48 LS = least squares||0.01|-0.02|0.4620
74005198|NCT02604433|147559823|SUPERIORITY||LS Mean of Difference|-2.22||||0.0543|TWO_SIDED|95.0|-4.48|0.04||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline myocardial T2\* as covariates.|luspatercept - placebo|Change from baseline at Week 48 LS = least square||0.04|-4.48|0.0543
74005199|NCT02604433|147559824|SUPERIORITY|||||||0.666||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Physical Health Domain Score - Change from Baseline at Week 24||||0.666
74005200|NCT02604433|147559824|SUPERIORITY|||||||0.384||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Total Score - Change from Baseline at Week 24||||0.384
74005201|NCT02604433|147559825|SUPERIORITY|||||||0.918||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Physical Functioning Domain - Change from Baseline at Week 24||||0.918
74005202|NCT02604433|147559825|SUPERIORITY|||||||0.857||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||General Health Domain - Change from Baseline at Week 24||||0.857
74005203|NCT02604433|147559825|SUPERIORITY|||||||0.839||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||PCS - Change from Baseline at Week 24||||0.839
74005204|NCT02604433|147559828|SUPERIORITY||Odds Ratio (OR)|7.6||||0.0015|TWO_SIDED|95.0|1.8|32.9||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.||32.9|1.8|0.0015
74005205|NCT02604433|147559831|SUPERIORITY||Mean Difference (Final Values)|-67.27||||0.0195|TWO_SIDED|95.0|-123.63|-10.91||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|≥ 33% Transfusion Burden Reduction||-10.91|-123.63|0.0195
74005206|NCT02604433|147559831|SUPERIORITY||Mean Difference (Final Values)|28.24||||0.7473|TWO_SIDED|95.0|-144.87|201.34||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|≥ 50% Transfusion Burden Reduction||201.34|-144.87|0.7473
74005207|NCT01498289|147559908|SUPERIORITY||Cox Proportional Hazard|0.91||||0.83|TWO_SIDED|95.0|0.41|2.05|||Regression, Cox|||||2.05|0.41|0.83
74005208|NCT01498289|147559909|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.02|TWO_SIDED|95.0|0.5|0.93|||Regression, Cox|||||0.93|0.50|0.02
74005209|NCT01498289|147559910|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2|TWO_SIDED|95.0|0.61|1.11|||Regression, Cox|||||1.11|0.61|0.20
74005210|NCT01498289|147559911|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
74005211|NCT01498289|147559912|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.41|TWO_SIDED|95.0|0.44|1.4|||Regression, Cox|||Statistical analysis for Q1 ERCC1||1.40|0.44|0.41
74005212|NCT01498289|147559912|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.06|TWO_SIDED|95.0|0.32|1.02|||Regression, Cox|||Statistical analysis for Q2 ERCC1||1.02|0.32|0.06
74005213|NCT01498289|147559912|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.66|TWO_SIDED|95.0|0.49|1.58|||Regression, Cox|||Statistical analysis for Q3 ERCC1||1.58|0.49|0.66
74005214|NCT01498289|147559912|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.3|TWO_SIDED|95.0|0.42|1.31|||Regression, Cox|||Statistical analysis for Q4 ERCC1||1.31|0.42|0.30
74005215|NCT00381303|147559941|NON_INFERIORITY_OR_EQUIVALENCE|Test for non-inferiority (Delta=15%)|Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|0.052||0.3|TWO_SIDED|95.0|-19.85|0.68||P-Value for difference (Female - Male): Test for non-inferiority (Delta=15%)|Regression, Logistic|Estimates from logistic regression analysis include baseline log10 viral load and baseline CD4 cell count as covariates and gender as a factor.||"Confidence interval of the difference in proportion of response between two sexes estimated by:~* Application of delta method to be obtained Standard Error (SE)~* Calculation of lower and upper bound using normal approximation to the difference in response rates"||0.68|-19.85|0.30
74005216|NCT01777269|147559962|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.0|||<|0.001|TWO_SIDED|95.0|-10.22|-5.79|||mixed-model repeated-measures|||||-5.79|-10.22|<0.001
74005217|NCT01777269|147559963|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.11|||<|0.001|TWO_SIDED|95.0|-6.01|-2.21|||mixed-model repeated-measures||Month 1|||-2.21|-6.01|<0.001
74005218|NCT01777269|147559963|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.43|||<|0.001|TWO_SIDED|95.0|-8.45|-4.41|||Adjusted mean difference||Month 3|||-4.41|-8.45|<0.001
74005219|NCT01777269|147559963|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.04|||<|0.001|TWO_SIDED|95.0|-11.31|-6.77|||mixed-model repeated-measures||Month 6|||-6.77|-11.31|<0.001
74005220|NCT01777269|147559963|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.82|||<|0.001|TWO_SIDED|95.0|-10.96|-6.67|||mixed-model repeated-measures||Month 9|||-6.67|-10.96|<0.001
74005221|NCT01777269|147559965|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2||||0.37|TWO_SIDED|95.0|-0.62|0.23|||mixed-model repeated-measures||Month 1|||0.23|-0.62|0.37
74005222|NCT01777269|147559965|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.24||||0.33|TWO_SIDED|95.0|-0.71|0.24|||mixed-model repeated-measures||Month 3|||0.24|-0.71|0.33
74005223|NCT01777269|147559965|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.37||||0.16|TWO_SIDED|95.0|-0.88|0.15|||mixed-model repeated-measures||Month 6|||0.15|-0.88|0.16
74005224|NCT01777269|147559965|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.68||||0.009|TWO_SIDED|95.0|-1.19|-0.17|||mixed-model repeated-measures||Month 9|||-0.17|-1.19|0.009
74005225|NCT01777269|147559965|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46||||0.091|TWO_SIDED|95.0|-0.99|0.07|||mixed-model repeated-measures||Month 12|||0.07|-0.99|0.091
74005226|NCT01777269|147559966|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.89|||<|0.001|TWO_SIDED|95.0|-4.07|-1.7|||mixed-model repeated-measures||Month 1|||-1.70|-4.07|<0.001
74005227|NCT01777269|147559966|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.24|||<|0.001|TWO_SIDED|95.0|-6.59|-3.9|||mixed-model repeated-measures||Month 3|||-3.90|-6.59|<0.001
74038355|NCT00600028|147629993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||The values represents three months on each intervention|||||0.001
74038356|NCT00600028|147629994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis||The values represents three months on each intervention|||||.0001
74038357|NCT03172481|147629995|OTHER|The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom SKAMP-C scores from each time point as the dependent variable. The repeated measures model adjusted means (LS-means) for PRC-063 and placebo were compared statistically using a t-test with an overall 5% significance level to evaluate efficacy. The LS-means estimate an overall treatment effect across the entire 13-hour classroom evaluation.|||||<|0.0001|||||||ANOVA|||||||<0.0001
74005228|NCT01777269|147559966|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.82|||<|0.001|TWO_SIDED|95.0|-8.3|-5.34|||mixed-model repeated-measures||Month 6|||-5.34|-8.30|<0.001
74005229|NCT01777269|147559966|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.05|||<|0.001|TWO_SIDED|95.0|-8.51|-5.59|||mixed-model repeated-measures||Month 9|||-5.59|-8.51|<0.001
74005230|NCT01777269|147559966|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.92|||<|0.001|TWO_SIDED|95.0|-8.47|-5.38|||mixed-model repeated-measures||Month 12|||-5.38|-8.47|<0.001
74005231|NCT01777269|147559967|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.94||||0.012|TWO_SIDED|95.0|-1.67|-0.21|||mixed-model repeated-measures||Month 1|||-0.21|-1.67|0.012
74005232|NCT01777269|147559967|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.93||||0.017|TWO_SIDED|95.0|-1.69|-0.17|||mixed-model repeated-measures||Month 3|||-0.17|-1.69|0.017
74005233|NCT01777269|147559967|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|||<|0.001|TWO_SIDED|95.0|-2.57|-0.88|||mixed-model repeated-measures||Month 6|||-0.88|-2.57|<0.001
74005234|NCT01777269|147559967|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15||||0.009|TWO_SIDED|95.0|-2.01|-0.3|||mixed-model repeated-measures||Month 9|||-0.30|-2.01|0.009
74005235|NCT01777269|147559967|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83||||0.047|TWO_SIDED|95.0|-1.65|-0.01|||mixed-model repeated-measures||Month 12|||-0.01|-1.65|0.047
74005236|NCT01777269|147559968|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.45|-0.85|||mixed-model repeated-measures||Week 2|||-0.85|-2.45|<0.001
74005237|NCT01777269|147559968|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55||||0.24|TWO_SIDED|95.0|-1.47|0.37|||mixed-model repeated-measures||Month 1|||0.37|-1.47|0.24
74005238|NCT01777269|147559968|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.27||||0.006|TWO_SIDED|95.0|-2.19|-0.36|||mixed-model repeated-measures||Month 3|||-0.36|-2.19|0.006
74005239|NCT01777269|147559968|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|||<|0.001|TWO_SIDED|95.0|-2.74|-0.72|||mixed-model repeated-measures||Month 6|||-0.72|-2.74|<0.001
74005240|NCT01777269|147559968|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.34||||0.013|TWO_SIDED|95.0|-2.4|-0.28|||mixed-model repeated-measures||Month 9|||-0.28|-2.40|0.013
74038358|NCT01709786|147630050|SUPERIORITY_OR_OTHER||Bland-Altman Analysis|1.49|||||TWO_SIDED|||||p-value is not reported since Bland-Altman is not a hypothesis testing framework.|Limits of agreement||Limits of agreement are -2.02 to 5.00. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.|||||
73878252|NCT00607087|147295522|SUPERIORITY_OR_OTHER|||||||0.019||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.019
73878253|NCT00607087|147295523|SUPERIORITY_OR_OTHER|||||||0.008||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.008
74005241|NCT01777269|147559968|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|||<|0.001|TWO_SIDED|95.0|-3.12|-0.83|||mixed-model repeated-measures||Month 12|||-0.83|-3.12|<0.001
74005242|NCT01777269|147559969|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.4||||0.036|TWO_SIDED|95.0|-0.78|-0.03|||mixed-model repeated-measures||Week 2|||-0.03|-0.78|0.036
74005243|NCT01777269|147559969|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0||||1|TWO_SIDED|95.0|-0.37|0.37|||mixed-model repeated-measures||Month 1|||0.37|-0.37|1.00
74005244|NCT01777269|147559969|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.26||||0.21|TWO_SIDED|95.0|-0.67|0.15|||mixed-model repeated-measures||Month 3|||0.15|-0.67|0.21
74005245|NCT01777269|147559969|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62||||0.009|TWO_SIDED|95.0|-1.09|-0.15|||mixed-model repeated-measures||Month 6|||-0.15|-1.09|0.009
74005246|NCT01777269|147559969|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.45||||0.056|TWO_SIDED|95.0|-0.91|0.01|||mixed-model repeated-measures||Month 9|||0.01|-0.91|0.056
74005247|NCT01777269|147559969|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.58||||0.023|TWO_SIDED|95.0|-1.08|-0.08|||mixed-model repeated-measures||Month 12|||-0.08|-1.08|0.023
74005248|NCT01777269|147559970|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.0|||<|0.001|TWO_SIDED|95.0|-3.89|-2.1|||mixed-model repeated-measures||Week 2|||-2.10|-3.89|<0.001
74005249|NCT01777269|147559970|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|||<|0.001|TWO_SIDED|95.0|-3.15|-1.06|||mixed-model repeated-measures||Month 1|||-1.06|-3.15|<0.001
74005250|NCT01777269|147559970|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.11|||<|0.001|TWO_SIDED|95.0|-3.25|-0.98|||mixed-model repeated-measures||Month 3|||-0.98|-3.25|<0.001
74005251|NCT01777269|147559970|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.53|||<|0.001|TWO_SIDED|95.0|-3.76|-1.3|||mixed-model repeated-measures||Month 6|||-1.30|-3.76|<0.001
74005252|NCT01777269|147559970|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3||||0.042|TWO_SIDED|95.0|-2.56|-0.05|||mixed-model repeated-measures||Month 9|||-0.05|-2.56|0.042
74005253|NCT01777269|147559970|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.51|||<|0.001|TWO_SIDED|95.0|-4.87|-2.14|||mixed-model repeated-measures||Month 12|||-2.14|-4.87|<0.001
74005254|NCT01777269|147559971|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.78|||<|0.001|TWO_SIDED|95.0|-10.07|-5.49|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=2 points improvement at any time post-baseline visit|||-5.49|-10.07|<0.001
74005255|NCT01777269|147559971|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.39|||<|0.001|TWO_SIDED|95.0|-9.79|-4.99|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=3 points improvement at any time post-baseline visit|||-4.99|-9.79|<0.001
74005256|NCT01777269|147559972|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.79|||<|0.001|TWO_SIDED|95.0|-10.22|-5.35|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=25 points improvement at any time post-baseline visit|||-5.35|-10.22|<0.001
74038359|NCT01709786|147630051|SUPERIORITY_OR_OTHER||Limits of agreement|-0.63|||||TWO_SIDED|||||p-value not reported since Bland-Altman is not a hypothesis testing framework.|Bland-Altman Analysis||Limits of agreement are -3.44 to 2.18. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.|||||
73878254|NCT00607087|147295523|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
73878255|NCT00607087|147295524|SUPERIORITY_OR_OTHER|||||||0.563||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.563
74005257|NCT01966471|147559976|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.827||95.0|0.71|1.32|||Log Rank|||||1.32|0.71|0.8270
74005258|NCT01966471|147559977|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9291||95.0|0.77|1.34|||Log Rank|||||1.34|0.77|0.9291
74005259|NCT01966471|147559978|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8756||95.0|0.74|1.3|||Log Rank|||||1.30|0.74|0.8756
74005260|NCT01966471|147559979|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9341||95.0|0.75|1.31|||Log Rank|||||1.31|0.75|0.9341
74005261|NCT01966471|147559980|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4577||95.0|0.61|1.25|||Log Rank|||||1.25|0.61|0.4577
74005262|NCT01966471|147559981|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.2864||95.0|0.83|1.84|||Log Rank|||||1.84|0.83|0.2864
74005263|NCT00954421|147560025|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.6|STANDARD_DEVIATION|19.4||0.026|TWO_SIDED|95.0|-30.61|-4.65|||two-sided sign-rank test||p-value assessed via sign-rank test (pre-planned method)|The null hypothesis is that the mean change in Tremor Rating Scale score from baseline to six months post-implant (with VIM and VO stimulators turned ON) will be zero||-4.65|-30.61|.026
74005264|NCT00954421|147560026|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.4|STANDARD_DEVIATION|9.1||0.011|TWO_SIDED|95.0|2.2|14.5||Sign rank test was pre-planned for P-value|Sign-Rank test||p-value assessed using sign rank test|The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when both stimulators are on (VIM and VO), versus when both stimulators are off, will be zero (i.e., that there will be no difference in effect between having both stimulators on versus both stimulators off)||14.5|2.2|0.011
74005265|NCT00954421|147560026|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73|STANDARD_DEVIATION|8.49||0.68||95.0|-4.96|6.42|||two-sided sign rank test|two sided sign rank test as pre-planned||The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when VO is on and VIM is off, versus when VIM is on and VO is off, will be zero (i.e., that there will be no difference in effect between having exclusively VIM versus VO on)||6.42|-4.96|.68
74005266|NCT03714425|147560039|SUPERIORITY||||||<|0.05||||||The primary research objective to measure perceived improvement in pain at three months was assessed using a two-sample t-test of PGIC scores between the two treatment groups using a type I error rate of 0.05 (two-sided).|t-test, 2 sided|Most of the analyses involved delta scores reflecting changes within subjects, though we compared PGIC raw scores rather than change scores.||||||<0.05
74005267|NCT03019796|147560041|OTHER|||||||0.04|||||||ANOVA|repeated measures||||||0.040
74005268|NCT03019796|147560042|OTHER|||||||0.054|||||||ANOVA|repeated measures||||||0.054
74038360|NCT00865189|147630062|SUPERIORITY_OR_OTHER|||||||0.015|||||||Binomial test|||This proportion was described for each treatment arm with a 95% confidence interval (CI) and compared with the standard proportion of 10% (CI) for each treatment arm.||||0.015
74038361|NCT00865189|147630062|SUPERIORITY_OR_OTHER|||||||0.906|||||||Binomial test|||This proportion was described for each treatment arm with a 95% CI and compared with the standard proportion of 10% (CI) using for each treatment arm.||||0.906
74038362|NCT01978509|147630073|SUPERIORITY|||||||0.7|||||||ANOVA|||||||0.70
74038363|NCT00418379|147630081|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
74038364|NCT00418379|147630081|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
74038365|NCT02666508|147630084|OTHER|Test conducted was a test of difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in DPIA from pre to post.|Mean Difference (Net)|-1.02||||0.001|TWO_SIDED|95.0|-1.6|-0.44|||Repeated Measures ANOVA|||||-0.44|-1.60|0.001
74038366|NCT02666508|147630085|OTHER|Test conducted was a test of the difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in hsCRP|Mean Difference (Net)|-0.18||||0.459|TWO_SIDED|95.0|-0.69|0.32|||Repeated Measures ANOVA|||||0.32|-0.69|0.459
74091016|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.71|STANDARD_ERROR_OF_MEAN|3.6166|||TWO_SIDED|95.0|-11.9|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-11.9|
74091017|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.09|STANDARD_ERROR_OF_MEAN|3.7073|||TWO_SIDED|95.0|-10.5|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.3|-10.5|
74091018|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.82|STANDARD_ERROR_OF_MEAN|4.186|||TWO_SIDED|95.0|-12.1|4.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.5|-12.1|
74038367|NCT03428997|147630113|EQUIVALENCE|Mixed-effects model, where the test material/negative control is a fixed effect and the subject is a random effect|Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.274|||||||2-sided t-test|||Testing hypothesis is that the mean score is equal between the compared treatments.||||0.274
74038368|NCT01397448|147630139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11|||<|0.001|TWO_SIDED|95.0|0.04|0.31|||Log Rank|||||0.31|0.04|<0.001
74038369|NCT01397448|147630139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05|||<|0.001|TWO_SIDED|95.0|0.01|0.23|||Log Rank|||||0.23|0.01|<0.001
74038370|NCT03337139|147630202|SUPERIORITY|||||||0.98||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|||Comparing groups on 13 week weight loss, prior to randomization.||||.98
74038371|NCT03337139|147630202|SUPERIORITY|||||||0.75||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|Controlling for Phase I weight loss||Comparing groups on 26 week weight loss||||.75
74038372|NCT03337139|147630202|SUPERIORITY|||||||0.02||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I weight loss||Comparing groups on 52 week weight loss||||.02
74038373|NCT03337139|147630203|SUPERIORITY|||||||0.12||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|||Comparing groups on 13 week MVPA||||.12
74038374|NCT03337139|147630203|SUPERIORITY|||||||0.16||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for changes in Phase I MVPA||Comparing groups on 52 week MVPA||||.16
74038375|NCT03337139|147630204|SUPERIORITY|||||||0.43||||||A priori threshold for statistical significant was p\<.05.|Fisher Exact|||Comparing groups on 26 week retention rates||||.43
74038376|NCT03337139|147630204|SUPERIORITY|||||||0.48||||||A priori threshold for statistical significance was p\<.05.|Fisher Exact|||Comparing groups on 52 week retention rates.||||.48
74005269|NCT03019796|147560043|OTHER|||||||0.04|||||||ANOVA|REPEATED MEASURES||||||0.040
74005270|NCT03019796|147560044|OTHER|||||||0.321|||||||ANOVA|REPEATED MEASURES||||||0.321
74005271|NCT03019796|147560045|OTHER|||||||0.401|||||||ANOVA|REPEATED MEASURES||||||0.401
74005272|NCT03019796|147560046|OTHER|||||||0.021|||||||ANOVA|REPEATED MEASURES||||||0.021
74005273|NCT00475033|147560101|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-2.4|||||TWO_SIDED|95.0|-5.3|-0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||-0.1|-5.3|
74005274|NCT00475033|147560102|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.19|||||TWO_SIDED|95.0|0.96|1.48|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Ratio of GMs (13vPnC, 7vPnC)||1.48|0.96|
74005275|NCT00475033|147560103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.6|1.7|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PT: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.7|-1.6|
74005276|NCT00475033|147560103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FHA: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.3|-1.3|
74005277|NCT00475033|147560103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|1.1|||||TWO_SIDED|95.0|-1.7|4.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRN: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||4.2|-1.7|
74005278|NCT00475033|147560103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-2.1|||||TWO_SIDED|95.0|-5.5|1.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FIM: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage||1.2|-5.5|
74005279|NCT00475033|147560104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.4|1.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.4|-1.4|
74005280|NCT00475033|147560105|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.27|||||TWO_SIDED|95.0|1.08|1.5|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Meningococcal C: Ratio of geometric means (13vPnC, 7vPnC)||1.50|1.08|
74005281|NCT00475033|147560110|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.14|||||TWO_SIDED|95.0|1.02|1.27|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PT: Ratio of geometric means (13vPnC, 7vPnC)||1.27|1.02|
74005282|NCT00475033|147560110|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.12|||||TWO_SIDED|95.0|1.01|1.25|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FHA: Ratio of geometric means (13vPnC, 7vPnC)||1.25|1.01|
74005283|NCT00475033|147560110|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.89|1.24|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRN: Ratio of geometric means (13vPnC, 7vPnC)||1.24|0.89|
74005284|NCT00475033|147560110|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.89|||||TWO_SIDED|95.0|0.78|1.02|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FIM: Ratio of geometric means (13vPnC, 7vPnC)||1.02|0.78|
74005285|NCT00475033|147560111|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-1.8|||||TWO_SIDED|95.0|-4.4|0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||0.1|-4.4|
74038377|NCT03337139|147630205|SUPERIORITY|||||||0.64||||||A priori threshold of statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on phone calls completed in Phase II (52 weeks)||||.64
74038378|NCT03337139|147630205|SUPERIORITY|||||||0.499||||||A priori threshold for statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on text messages completed in Phase II (52 weeks)||||.499
74038379|NCT03337139|147630206|SUPERIORITY|||||||0.86||||||A priori threshold for statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on TAQ scores at 52 weeks||||.86
74038380|NCT03337139|147630207|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of weight during Phase II||||.002
74038381|NCT03337139|147630207|SUPERIORITY|||||||0.001||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of eating during Phase II||||.001
74005286|NCT00475033|147560112|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.91|||||TWO_SIDED|95.0|0.75|1.12|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRP in Hib: Ratio of geometric means (13vPnC, 7vPnC)||1.12|0.75|
73878256|NCT00607087|147295524|SUPERIORITY_OR_OTHER|||||||0.186||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.186
73878257|NCT00607087|147295525|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
74005287|NCT00475033|147560113|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-3.0|||||TWO_SIDED|95.0|-9.4|3.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRP: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||3.4|-9.4|
74005288|NCT03444324|147560133|NON_INFERIORITY|The primary efficacy analysis of this endpoint was to test non-inferiority in the Per-protocol Set. The final analysis was performed using a two-way analysis of variance (ANOVA). Non-inferiority was to be demonstrated if the upper confidence limit of the two-sided 95 % confidence interval (CI) for the difference in the least squares mean (LSM) was less than the non-inferiority margin (150 mL).|Difference in LSM|-279.43|||<|0.001|TWO_SIDED|95.0|-552.38|-6.48||p-value from Van Elteren test, stratified by predictive blood loss (\> 1,000 mL to = 2,000 mL and \>2,000 mL)|Van Elteren test|||||-6.48|-552.38|<0.001
74005289|NCT03444324|147560134|OTHER||Difference in response rate|38.1|||<|0.001|TWO_SIDED|95.0|26.0|50.3|||Cochran-Mantel-Haenszel|P-value is from a Cochran-Mantel-Haenszel model stratified by predictive blood loss (\> 1,000 mL to ≤ 2,000 mL and \> 2,000 mL).||||50.3|26|<0.001
74005290|NCT03444324|147560135|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
74005291|NCT03444324|147560141|OTHER||Difference in LSM|-15.5|||<|0.831|TWO_SIDED|95.0|-157.83|126.88|||ANOVA|||||126.88|-157.83|<0.831
74005292|NCT03444324|147560142|OTHER||Difference in LSM|12.4|||=|0.809|TWO_SIDED|95.0|-88.84|113.66|||ANOVA|||||113.66|-88.84|=0.809
74005293|NCT03444324|147560143|OTHER||Difference in proportion|-4.8|||=|0.022|TWO_SIDED|95.0|-8.9|-0.7|||Cochran-Mantel-Haenszel|||||-0.7|-8.9|=0.022
74005294|NCT06515483|147560148|OTHER||Mean Difference (Final Values)|0.079||||0.323|TWO_SIDED|95.0|-0.095|0.254||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline PLI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||0.254|-0.095|0.323
74005295|NCT06515483|147560148|OTHER||Mean Difference (Final Values)|-0.036||||0.371|TWO_SIDED|95.0|-0.156|0.084||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day PLI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.084|-0.156|0.371
74005296|NCT06515483|147560148|OTHER||Mean Difference (Net)|-0.115||||0.12|TWO_SIDED|95.0|-0.262|0.031||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Comparing the mean difference in PLI from baseline to 30 days between groups|||0.031|-0.262|0.120
74005297|NCT06515483|147560149|OTHER||Mean Difference (Final Values)|0.078||||0.27|TWO_SIDED|95.0|-0.048|0.204||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline MGI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||0.204|-0.048|0.270
74005298|NCT06515483|147560149|OTHER||Mean Difference (Final Values)|-0.085||||0.071|TWO_SIDED|95.0|-0.203|0.033||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day MGI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.033|-0.203|0.071
74005299|NCT06515483|147560149|OTHER||Mean Difference (Net)|-0.163|||<|0.001|TWO_SIDED|95.0|-0.249|-0.077|||t-test, 2 sided||Comparing the mean difference in MGI from baseline to 30 days between groups|||-0.077|-0.249|<0.001
74005300|NCT06515483|147560150|OTHER||Mean Difference (Final Values)|0.31||||0.902|TWO_SIDED|95.0|-6.23|6.85||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline BOMP between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||6.85|-6.23|0.902
73878258|NCT00607087|147295525|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
73878259|NCT00607087|147295526|SUPERIORITY_OR_OTHER|||||||1||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||1.000
73878260|NCT00607087|147295526|SUPERIORITY_OR_OTHER|||||||0.701||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.701
74005301|NCT06515483|147560150|OTHER||Mean Difference (Final Values)|-8.22||||0.006|TWO_SIDED|95.0|-16.46|0.02||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day BOMP between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.02|-16.46|0.006
74005302|NCT06515483|147560150|OTHER||Mean Difference (Net)|-8.53||||0.032|TWO_SIDED|95.0|-16.31|-0.75||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Comparing the mean difference in BOMP from baseline to 30 days between groups|||-0.75|-16.31|0.032
74005303|NCT01676909|147560155|SUPERIORITY|||||||0.362|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.362
73878261|NCT00607087|147295529|SUPERIORITY_OR_OTHER|||||||0.078||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|ANCOVA|ANCOVA adjusted on HbA1c value at the start of the first period||||||0.078
73878262|NCT00607087|147295529|SUPERIORITY_OR_OTHER|||||||0.938||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|ANCOVA|ANCOVA adjusted on HbA1c level at the start of the first period||||||0.938
73878263|NCT01774799|147295664|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.69|1.69||||||||1.69|0.69|
73957236|NCT04771273|147450411|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-9.12|||<|0.0001|TWO_SIDED|95.0|-11.21|-7.03||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-7.03|-11.21|<.0001
74005304|NCT01676909|147560156|SUPERIORITY|||||||0.026|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.026
74005305|NCT01676909|147560157|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.032
74005306|NCT01676909|147560158|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||A logistic mixed effects model over two 6-month time periods (prior to baseline and between baseline and the 6-month follow-up visit) was used. Terms in the model included group, binary time (pre-f/u versus pre-baseline), and group by time interaction. Two-sided alpha = .05 level tests were used. The hypothesis that the proportion with ER visits would decrease in the Living Well group versus the control group was tests by test of the interaction term.||||.64
74005307|NCT01676909|147560159|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||<.0001
74005308|NCT01676909|147560160|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.038
74005309|NCT01676909|147560161|SUPERIORITY|||||||0.544|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.544
74038382|NCT03337139|147630207|SUPERIORITY|||||||0.25||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of physical activity during Phase II||||.25
73878264|NCT01774799|147295665|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.66|2.2||||||||2.20|0.66|
73878265|NCT01774799|147295666|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.58|1.58||||||||1.58|0.58|
73878266|NCT01774799|147295667|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED|95.0|1.13|2.82||||||||2.82|1.13|
73878267|NCT01774799|147295668|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
73878268|NCT04290039|147295747|OTHER|Estimation only|Geometric ratio of least-square means|0.579|||||TWO_SIDED|90.0|0.5265|0.636|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6360|0.5265|
73878269|NCT04290039|147295747|OTHER|Estimation only|Geometric ratio of least-square means|0.349|||||TWO_SIDED|90.0|0.3171|0.3839|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.3839|0.3171|
73878270|NCT04290039|147295747|OTHER|Estimation only|Geometric ratio of least-square means|0.603|||||TWO_SIDED|90.0|0.5524|0.6582|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6582|0.5524|
73878271|NCT04290039|147295748|OTHER|Estimation only|Geometric ratio of least-square means|0.546|||||TWO_SIDED|90.0|0.4971|0.6004|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6004|0.4971|
73878272|NCT04290039|147295748|OTHER|Estimation only|Geometric ratio of least-square means|0.306|||||TWO_SIDED|90.0|0.2788|0.3367|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.3367|0.2788|
74005310|NCT01676909|147560162|SUPERIORITY|||||||0.699|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.699
74005311|NCT01676909|147560163|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.006
74005312|NCT01676909|147560164|SUPERIORITY|||||||0.762|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.762
74005313|NCT01676909|147560165|SUPERIORITY|||||||0.326|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.326
74005314|NCT01676909|147560166|SUPERIORITY|||||||0.667|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.667
74005315|NCT01676909|147560167|SUPERIORITY|||||||0.142|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.142
74005316|NCT01676909|147560168|SUPERIORITY|||||||0.342|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.342
74005317|NCT01676909|147560169|SUPERIORITY|||||||0.563|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.563
74005318|NCT01676909|147560170|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.004
74005319|NCT01676909|147560171|SUPERIORITY|||||||0.727|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.727
74005320|NCT01676909|147560172|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.446
74005321|NCT01676909|147560173|SUPERIORITY|||||||0.459|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.459
74038383|NCT03337139|147630208|SUPERIORITY|||||||0.005||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I perceived supportive accountability||Comparing groups on changes in perceived accountability during Phase II||||.005
73878273|NCT04290039|147295748|OTHER|Estimation only|Geometric ratio of least-square means|0.561|||||TWO_SIDED|90.0|0.5104|0.6164|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6164|0.5104|
73878274|NCT04290039|147295749|OTHER|Estimation only|Geometric ratio of least-square means|0.549|||||TWO_SIDED|90.0|0.4273|0.7118|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.7118|0.4273|
73878275|NCT04290039|147295749|OTHER|Estimation only|Geometric ratio of least-square means|0.049|||||TWO_SIDED|90.0|0.0381|0.0641|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.0641|0.0381|
73878276|NCT04290039|147295749|OTHER|Estimation only|Geometric ratio of least-square means|0.09|||||TWO_SIDED|90.0|0.0695|0.1167|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.1167|0.0695|
74005322|NCT01676909|147560174|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.038
74005323|NCT01676909|147560175|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.238
74005324|NCT01676909|147560176|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.011
74005325|NCT01676909|147560177|SUPERIORITY|||||||0.709|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.709
74005326|NCT01676909|147560178|SUPERIORITY|||||||0.134|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.134
74005327|NCT01676909|147560179|SUPERIORITY|||||||0.045|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.045
74005328|NCT01676909|147560180|SUPERIORITY|||||||0.099|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.099
74005329|NCT01676909|147560181|SUPERIORITY|||||||0.852|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.852
74005330|NCT01676909|147560182|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.285
74038384|NCT00077376|147630209|SUPERIORITY_OR_OTHER||Objective response rate|41.0|||||TWO_SIDED|95.0|26.0|58.0||||||||58|26|
74038385|NCT00077376|147630210|SUPERIORITY_OR_OTHER||Objective response rate|44.0|||||TWO_SIDED|95.0|31.0|58.0||||||||58|31|
73878277|NCT02413918|147295769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_DEVIATION|20.0|<|0.0094|TWO_SIDED|||||p value is not adjusted for multiple comparisons (see above). A priori threshold for significance was p\<0.05.|t-test, 2 sided|||BISS Outcomes: Mean changes in depression and mania for study completers were measured. The a priori hypothesis was a mean change of 50%.||||<0.0094
73878278|NCT02413918|147295769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|STANDARD_DEVIATION|10.1|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||BISS Outcomes: Mean changes in mania for study completers were measured. The a priori hypothesis was a mean change of 50%.||||<0.0001
73878279|NCT04233801|147295771|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.71|||Mixed model repeated measures|||||-0.71|-1.28|< 0.0001
73878280|NCT04233801|147295771|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.26|-0.7|||Mixed model repeated measures|||||-0.70|-1.26|< 0.0001
73878281|NCT04233801|147295772|OTHER|Logistic regression including treatment, baseline Estimated glomerular filtration rate (eGFR), background therapy, and continuous baseline HbA1c.|Odds Ratio (OR)|2.29||||0.1375|TWO_SIDED|95.0|0.77|6.83|||Regression, Logistic|||||6.83|0.77|0.1375
73878282|NCT04233801|147295772|OTHER|Logistic regression including treatment, baseline Estimated glomerular filtration rate (eGFR), background therapy, and continuous baseline HbA1c.|Odds Ratio (OR)|6.01||||0.0008|TWO_SIDED|95.0|2.11|17.1|||Regression, Logistic|||||17.10|2.11|0.0008
73878283|NCT04233801|147295773|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.34|||Mixed model repeated measures|||||-1.34|-2.66|< 0.0001
74005331|NCT01676909|147560183|SUPERIORITY|||||||0.222|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.222
74005332|NCT01176968|147560184|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.581|||<|0.0001|TWO_SIDED|95.0|0.446|0.756||All analyses for primary endpoint were tested at two-sided, α-level of 0.05, without adjusting for multiplicity.|Regression, Cox|||Hazard ratio, 95% confidence interval (CI) of hazard ratio, and p-value for the Primary Analysis based on a Cox proportional hazard model with treatment as the major factor, adjusted for baseline estimated glomerular filtration rate (eGFR), with/without previous MI, time of first dose administered post onset of index symptom, and location of index MI anterior or non-anterior.||0.756|0.446|< 0.0001
74005333|NCT01176968|147560185|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.562||||0.6406|TWO_SIDED|95.0|0.05|6.308|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||6.308|0.050|0.6406
74005334|NCT01176968|147560186|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.726||||0.5338|TWO_SIDED|95.0|0.265|1.99|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||1.990|0.265|0.5338
74005335|NCT01176968|147560188|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.083||||0.8042|TWO_SIDED|95.0|0.575|2.04|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||2.040|0.575|0.8042
74005336|NCT01176968|147560189|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.598||||0.0003|TWO_SIDED|95.0|0.452|0.791|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||0.791|0.452|0.0003
74005337|NCT01176968|147560190|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.069||||0.9353|TWO_SIDED|95.0|0.213|5.371|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||5.371|0.213|0.9353
74005338|NCT01176968|147560191|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.6||||0.3757|TWO_SIDED|95.0|0.566|4.525|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||4.525|0.566|0.3757
74038386|NCT03784027|147630238|SUPERIORITY||Mean Difference (Final Values)|8.7|||<|0.001|TWO_SIDED|95.0|7.4|9.9|||Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||9.9|7.4|<0.001
73878284|NCT04233801|147295773|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.32|||<|0.0001|TWO_SIDED|95.0|-1.96|-0.67|||Mixed model repeated measures|||||-0.67|-1.96|< 0.0001
73878285|NCT04233801|147295774|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-3.6||||0.0774|TWO_SIDED|95.0|-7.61|0.4|||Mixed model repeated measures|||||0.40|-7.61|0.0774
73878286|NCT04233801|147295774|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.01||||0.616|TWO_SIDED|95.0|-4.98|2.96|||Mixed model repeated measures|||||2.96|-4.98|0.6160
73878287|NCT04233801|147295775|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.78||||0.1222|TWO_SIDED|95.0|-4.05|0.48|||Mixed model repeated measures|||||0.48|-4.05|0.1222
73878288|NCT04233801|147295775|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|0.65||||0.5687|TWO_SIDED|95.0|-1.59|2.89|||Mixed model repeated measures|||||2.89|-1.59|0.5687
74005339|NCT01176968|147560192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45||||0.1744|TWO_SIDED|95.0|-3.55|0.65|||ANCOVA|||ANCOVA model was used with observed value as the dependent variable, treatment as a major factor, and baseline QRS duration, baseline eGFR, with/without previous MI, time (in hours) of first dose administered post onset of index symptom, and location of index MI (anterior versus all other locations) as covariates.||0.65|-3.55|0.1744
74005340|NCT01176968|147560193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.7123|TWO_SIDED|95.0|-0.1|0.14||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.||0.14|-0.10|0.7123
74005341|NCT01176968|147560193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.4105|TWO_SIDED|95.0|-0.05|0.13||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.||0.13|-0.05|0.4105
74005342|NCT01176968|147560194|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
74005343|NCT01176968|147560194|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.5552|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.5552
74005344|NCT01176968|147560194|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Aldosterone, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||< 0.0001
74005345|NCT01176968|147560194|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
74005346|NCT01176968|147560194|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
74005347|NCT01176968|147560194|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3347|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Serum Cortisol, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.3347
74005348|NCT01176968|147560195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0005
74005349|NCT01176968|147560195|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
74005350|NCT01176968|147560195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1558|TWO_SIDED||||||Wilcoxon-Rank Sum test|||For Biomarker- PIIINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.1558
74005351|NCT01176968|147560195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0008
74005352|NCT01176968|147560195|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
74005353|NCT01176968|147560195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0293|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Galecting 3, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0293
74005354|NCT01176968|147560195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1723|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.1723
74005355|NCT01176968|147560195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0295|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0295
74005356|NCT01176968|147560195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0865|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- PINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0865
74005357|NCT01176968|147560196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0944|TWO_SIDED||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0944
74005358|NCT01176968|147560196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0360
74005359|NCT01176968|147560196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6459|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- ICTP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.6459
74005360|NCT01176968|147560197|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
74005361|NCT01176968|147560197|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
74005362|NCT01176968|147560197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0801|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Interleukin-6, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0801
74005363|NCT00819286|147560221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||3 Month CT Scores (Plates vs Wires)||||0.003
74005364|NCT00819286|147560221|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||6 Month CT Scores (Plates vs Wires)||||0.01
74005365|NCT00819286|147560222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.93||95.0|||||t-test, 1 sided|||Plates vs Wires||||0.93
74005366|NCT00078754|147560223|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|TWO_SIDED||||||ANCOVA|||||||0.622
74005367|NCT00078754|147560224|SUPERIORITY|||||||0.029||||||LHA score main effect.|ANCOVA|The LHA Score F\[1,83\] = 4.91, p = 0.029; Condition F\[2,83\] = 0.20, p = 0.815; Condition x LHA Score F\[2,83\] = 0.255, p = 0.799.||The hypothesis was that subjects with LHA Scores = 18 or more would respond better to divalproex (than fluoxetine) while those with LHA scores = or \< 17 would respond better to fluoxetine (than divalproex).||||0.029
74005368|NCT00078754|147560224|SUPERIORITY||Mean Difference (Final Values)|19.0|STANDARD_ERROR_OF_MEAN|2.7||0.8|TWO_SIDED||||||ANCOVA|Baseline OAS-M Aggression score as covariate.||ANCOVA at endpoint with baseline OAS-M AGG score as covariate.||||0.80
74005369|NCT00986440|147560233|SUPERIORITY||Z statistic for difference|3.92|||<|0.0001|TWO_SIDED||||||2-sided P value for z test|||||||<0.0001
74005370|NCT00986440|147560233|SUPERIORITY||Hazard Ratio, log|-0.41|||||TWO_SIDED|||||||||||||
74038387|NCT03784027|147630239|SUPERIORITY||Mean Difference (Final Values)|-8.5|||<|0.001|TWO_SIDED|95.0|-9.9|-7.1||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-7.1|-9.9|<0.001
74038388|NCT03784027|147630240|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-0.3|-0.5|<0.001
74038389|NCT03784027|147630241|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-4.9|-2.9|||Mixed Models Analysis|||||-2.9|-4.9|<0.001
74091019|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.67|STANDARD_ERROR_OF_MEAN|3.4254|||TWO_SIDED|95.0|-9.5|4.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.1|-9.5|
74005371|NCT00986440|147560234|SUPERIORITY|||||||0.038|||||||Log Rank|||||||0.0380
74005372|NCT00986440|147560234|SUPERIORITY|||||||0.1773|||||||Peto-Peto-Prentice|||||||0.1773
74005373|NCT00986440|147560234|SUPERIORITY|||||||0.2844|||||||Wilcoxon (Mann-Whitney)|||||||0.2844
74005374|NCT00986440|147560234|SUPERIORITY|||||||0.114|||||||Tarone-Ware|||||||0.1140
74005375|NCT00986440|147560235|SUPERIORITY|||||||0.1213|||||||Log Rank|||||||0.1213
74005376|NCT00803270|147560239|SUPERIORITY_OR_OTHER||Difference of proportions|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.99|TWO_SIDED|95.0|-0.28|0.44|||Fisher Exact|||||0.44|-0.28|0.99
74005377|NCT00803270|147560240|SUPERIORITY_OR_OTHER||difference of proportions|0.45|STANDARD_ERROR_OF_MEAN|0.21||0.08|TWO_SIDED|95.0|0.03|0.87||Fisher's Exact Test of equality of percent meeting optimal outcome.|Fisher Exact|||||0.87|0.03|0.08
74005378|NCT00593957|147560251|SUPERIORITY_OR_OTHER||||||<|0.4|||||||t-test, 2 sided|||||||<0.40
74005379|NCT00593957|147560251|SUPERIORITY_OR_OTHER||||||<|0.62||95.0|||||t-test, 2 sided|||||||<0.62
74005380|NCT00593957|147560251|SUPERIORITY_OR_OTHER||||||<|0.38||95.0|||||t-test, 2 sided|||||||<0.38
74005381|NCT00593957|147560253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.38|||<|0.1|||||||ANOVA|||Null hypothesis is that there would be no significant difference in social abilities as measured by the SSI score in this treatment group baseline to 6 months post-treatment.||||<0.10
74005382|NCT00593957|147560253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|||<|0.5|||||||ANOVA|||||||<0.50
74005383|NCT00593957|147560253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|||<|0.48|||||||ANOVA|||||||<0.48
74005384|NCT00593957|147560254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.947|||<|0.05|||||||ANOVA|||||||<0.05
74005385|NCT02340091|147560283|SUPERIORITY||Subjects % with difference in VAS ≥ 10mm|0.9194|||||TWO_SIDED|95.0|0.8|0.97||||||||0.97|0.80|
74005386|NCT01163721|147560327|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.53|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|-0.93|-0.13||P-value is from an Analysis of Covariance (ANCOVA) model with treatment as factor and baseline HbA1c value as covariate. Due to the exploratory nature of this study, there were no adjustments for multiplicity.|ANCOVA|||Assuming a common standard deviation of 1.1%, 60 evaluable participants would provide 93% power to detect a statistically significant -1.0% difference in change from baseline HbA1c at Week 12 between ranolazine and placebo (2-sided alpha = 0.05). 80 participants were randomized to ensure at least 60 evaluable participants.||-0.13|-0.93|0.010
74005387|NCT01163721|147560328|SUPERIORITY_OR_OTHER||difference in LSM|-15.4|STANDARD_ERROR_OF_MEAN|12.83||0.234|TWO_SIDED|95.0|-41.0|10.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA|||||10.2|-41.0|0.234
74005388|NCT01163721|147560329|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-2.5|STANDARD_ERROR_OF_MEAN|9.38||0.794|TWO_SIDED|95.0|-21.1|16.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA|||||16.2|-21.1|0.794
74005389|NCT01786239|147560330|SUPERIORITY_OR_OTHER|||||||0.0493|||||||Mixed Models Analysis|||||||0.0493
74005390|NCT02511678|147560334|SUPERIORITY|||||||0.0746||||||The 1-sided p-value was based on a t-test against a performance goal of -2.|t-test, 1 sided|||||||0.0746
74091020|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.64|STANDARD_ERROR_OF_MEAN|2.5461|||TWO_SIDED|95.0|-8.7|1.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.4|-8.7|
74091021|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.46|STANDARD_ERROR_OF_MEAN|2.4848|||TWO_SIDED|95.0|-7.4|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-7.4|
74091022|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.27|STANDARD_ERROR_OF_MEAN|2.8811|||TWO_SIDED|95.0|-9.0|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-9.0|
74091023|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.91|STANDARD_ERROR_OF_MEAN|3.4569|||TWO_SIDED|95.0|-9.8|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-9.8|
74005391|NCT01295281|147560344|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Two catheters were tested regarding subjects' perception when using them, in a cross over design. After using each catheter for 1 week the subjects were asked: Do you experience discomfort when using your catheter?, and the subjects were supposed to answer Yes or No. The hypothesis to be investigated was that the tolerability/perception was about the same for each type of catheter, i.e. the POBE 2.0 should be non-inferior compared to PVC. H0: p(disc. POBE - Yes) = p(disc. PVC - Yes)"||||||0.0066|||||||McNemar|||The size of the target population was estimated by calculating 95% Confidence Interval (CI) of a possible difference between the two catheter types. The width of the interval was decided on the proportion of patients who would prefer one or the other catheter. Max width was seen when both proportions were 0.5. A total of 90 evaluable subjects limited the maximum width to 0.41, which was considered narrow enough from a scientific point of view, why this sample size was used in the study.||||0.0066
74005392|NCT00292461|147560357|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||||||0.240
74005393|NCT00292461|147560358|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Cochran-Mantel-Haenszel|||||||0.460
74005394|NCT00292461|147560359|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Cochran-Mantel-Haenszel|||||||0.079
74005395|NCT00292461|147560360|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Cochran-Mantel-Haenszel|||||||0.860
74005396|NCT05629962|147560381|SUPERIORITY|||||||0.954|||||||Cochran-Mantel-Haenszel|||||||0.954
74005397|NCT05640648|147560388|OTHER||Incidence rate ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.62|2.09|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||2.09|1.62|<0.001
74005398|NCT05640648|147560389|OTHER||Incidence Rate Ratio|7.46||||0.002|TWO_SIDED|95.0|2.06|26.95|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||26.95|2.06|0.002
74005399|NCT05640648|147560390|OTHER||Incidence Rate Ratio|1.25||||0.5|TWO_SIDED|95.0|0.65|2.42|||Mixed Models Analysis|Mixed effects poisson model adjusting for time and group (paired healthcentres, based on randomization)||||2.42|0.65|0.50
74005400|NCT05640648|147560393|OTHER||Incidence Rate Ratio|4.75|||<|0.001|TWO_SIDED|95.0|2.07|10.91|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||10.91|2.07|<0.001
74005401|NCT04484259|147560394|NON_INFERIORITY|non-inferiority margin 45 PRU|Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-23.0|38.0||||||The primary end point was non-inferiority of Ticagrelor 60 mg monotherapy vs. aspirin plus Ticagrelor 60 mg||38|-23|
74005402|NCT04908189|147560399|SUPERIORITY||Adjusted Mean Difference|-0.4743|STANDARD_ERROR_OF_MEAN|0.08735|<|0.0001|TWO_SIDED|95.0|-0.6455|-0.3031|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||-0.3031|-0.6455|<0.0001
74005403|NCT04908189|147560400|SUPERIORITY||Adjusted mean difference|-0.1126|STANDARD_ERROR_OF_MEAN|0.03511||0.0013|TWO_SIDED|95.0|-0.1814|-0.0438|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||-0.0438|-0.1814|0.0013
74005404|NCT04908189|147560402|SUPERIORITY||Adjusted mean difference|2.042|STANDARD_ERROR_OF_MEAN|0.5421||0.0002|TWO_SIDED|95.0|0.98|3.105|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||3.105|0.980|0.0002
74005405|NCT04908189|147560405|SUPERIORITY||Adjusted mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.61||0.2017|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||2.0|-0.4|0.2017
74005406|NCT04908189|147560409|SUPERIORITY||Adjusted mean difference|0.0643|STANDARD_ERROR_OF_MEAN|0.02831||0.0231|TWO_SIDED|95.0|0.0088|0.1198|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.1198|0.0088|0.0231
74005407|NCT04908189|147560409|SUPERIORITY||Adjusted mean difference|0.0085|STANDARD_ERROR_OF_MEAN|0.03126||0.7865|TWO_SIDED|95.0|-0.0528|0.0697|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0697|-0.0528|0.7865
74005408|NCT04908189|147560409|SUPERIORITY||Adjusted mean difference|-0.0515|STANDARD_ERROR_OF_MEAN|0.03386||0.128|TWO_SIDED|95.0|-0.1179|0.0148|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||0.0148|-0.1179|0.1280
74005409|NCT04908189|147560409|SUPERIORITY||Adjusted mean differnce|-0.0541|STANDARD_ERROR_OF_MEAN|0.0346||0.118|TWO_SIDED|95.0|-0.1219|0.0137|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||0.0137|-0.1219|0.1180
74005410|NCT04908189|147560409|SUPERIORITY||Adjusted mean difference|-0.1126|STANDARD_ERROR_OF_MEAN|0.03511||0.0013|TWO_SIDED|95.0|-0.1814|-0.0438|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.0438|-0.1814|0.0013
74005411|NCT04908189|147560414|SUPERIORITY||Adjusted mean difference|0.692|STANDARD_ERROR_OF_MEAN|0.4384||0.1147|TWO_SIDED|95.0|-0.168|1.551|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||1.551|-0.168|0.1147
74005412|NCT04908189|147560414|SUPERIORITY||Adjusted mean difference|1.999|STANDARD_ERROR_OF_MEAN|0.5147||0.0001|TWO_SIDED|95.0|0.991|3.008|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||3.008|0.991|0.0001
74005413|NCT04908189|147560414|SUPERIORITY||Adjusted mean difference|2.042|STANDARD_ERROR_OF_MEAN|0.5421||0.0002|TWO_SIDED|95.0|0.98|3.105|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||3.105|0.980|0.0002
74005414|NCT04908189|147560418|SUPERIORITY||Adjusted mean difference|-0.284|STANDARD_ERROR_OF_MEAN|0.567||0.6159|TWO_SIDED|95.0|-1.396|0.827|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.827|-1.396|0.6159
74005415|NCT04908189|147560418|SUPERIORITY||Adjusted mean difference|0.829|STANDARD_ERROR_OF_MEAN|0.625||0.1847|TWO_SIDED|95.0|-0.396|2.054|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||2.054|-0.396|0.1847
74005416|NCT04908189|147560418|SUPERIORITY||Adjusted mean difference|1.145|STANDARD_ERROR_OF_MEAN|0.673||0.0888|TWO_SIDED|95.0|-0.174|2.464|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||2.464|-0.174|0.0888
74005417|NCT04908189|147560419|SUPERIORITY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.1924|TWO_SIDED|95.0|-1.6|0.3|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.3|-1.6|0.1924
74005418|NCT04908189|147560419|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.7601|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.8|-1.20|0.7601
74005419|NCT04908189|147560419|SUPERIORITY||Adjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.59||0.0303|TWO_SIDED|95.0|0.1|2.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||2.4|0.1|0.0303
74005420|NCT04908189|147560419|SUPERIORITY||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.63||0.4747|TWO_SIDED|95.0|-0.8|1.7|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||1.7|-0.8|0.4747
74005421|NCT04908189|147560419|SUPERIORITY||Adjusted mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.61||0.2017|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||2.0|-0.4|0.2017
74005422|NCT04908189|147560421|SUPERIORITY||Adjusted mean difference|-0.077|STANDARD_ERROR_OF_MEAN|0.1015||0.4459|TWO_SIDED|95.0|-0.276|0.122|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.122|-0.276|0.4459
74005423|NCT04908189|147560421|SUPERIORITY||Adjusted mean difference|-0.232|STANDARD_ERROR_OF_MEAN|0.1164||0.0461|TWO_SIDED|95.0|-0.46|-0.004|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||-0.004|-0.460|0.0461
74005424|NCT04908189|147560421|SUPERIORITY||Adjusted mean difference|-0.598|STANDARD_ERROR_OF_MEAN|0.1321|<|0.0001|TWO_SIDED|95.0|-0.857|-0.339|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.339|-0.857|<0.0001
74005425|NCT04908189|147560421|SUPERIORITY||Adjusted mean difference|-0.605|STANDARD_ERROR_OF_MEAN|0.1416|<|0.0001|TWO_SIDED|95.0|-0.882|-0.327|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.327|-0.882|<0.0001
74005426|NCT04908189|147560421|SUPERIORITY||Adjusted mean difference|-0.786|STANDARD_ERROR_OF_MEAN|0.1455|<|0.0001|TWO_SIDED|95.0|-1.071|-0.501|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.501|-1.071|<0.0001
74005427|NCT04908189|147560422|SUPERIORITY||Adjusted mean difference|0.3525|STANDARD_ERROR_OF_MEAN|0.9227||0.7025|TWO_SIDED|95.0|-1.456|2.1609|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||2.1609|-1.4560|0.7025
74005428|NCT04908189|147560422|SUPERIORITY||Adjusted mean difference|-1.373|STANDARD_ERROR_OF_MEAN|0.93331||0.1413|TWO_SIDED|95.0|-3.2023|0.4562|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.4562|-3.2023|0.1413
74005429|NCT04908189|147560422|SUPERIORITY||Adjused mean difference|-3.7522|STANDARD_ERROR_OF_MEAN|1.10374||0.0007|TWO_SIDED|95.0|-5.9155|-1.589|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-1.5890|-5.9155|0.0007
74005430|NCT04908189|147560422|SUPERIORITY||Adjusted mean difference|-4.8072|STANDARD_ERROR_OF_MEAN|1.13857|<|0.0001|TWO_SIDED|95.0|-7.0388|-2.5757|||ANOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-2.5757|-7.0388|<0.0001
74005431|NCT04908189|147560422|SUPERIORITY||Adjusted mean difference|-6.2006|STANDARD_ERROR_OF_MEAN|1.2284|<|0.0001|TWO_SIDED|95.0|-8.6082|-3.793|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-3.7930|-8.6082|<0.0001
74005432|NCT04908189|147560426|SUPERIORITY||Adjusted mean difference|0.0318|STANDARD_ERROR_OF_MEAN|0.05613||0.5707|TWO_SIDED|95.0|-0.0782|0.1419|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.1419|-0.0782|0.5707
74005433|NCT04908189|147560426|SUPERIORITY||Adjusted mean difference|-0.0833|STANDARD_ERROR_OF_MEAN|0.06303||0.1862|TWO_SIDED|95.0|-0.2069|0.0402|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0402|-0.2069|0.1862
74005434|NCT04908189|147560426|SUPERIORITY||Adjusted mean difference|-0.2958|STANDARD_ERROR_OF_MEAN|0.07854||0.0002|TWO_SIDED|95.0|-0.4497|-0.1418|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.1418|-0.4497|0.0002
74005435|NCT04908189|147560426|SUPERIORITY||Adjusted mean difference|-0.3262|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.4889|-0.1635|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.1635|-0.4889|<0.0001
74005436|NCT04908189|147560426|SUPERIORITY||Adjusted mean difference|-0.4743|STANDARD_ERROR_OF_MEAN|0.08735|<|0.0001|TWO_SIDED|95.0|-0.6455|-0.3031|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.3031|-0.6455|<0.0001
74005437|NCT04908189|147560429|SUPERIORITY||Adjusted mean difference|-0.0758|STANDARD_ERROR_OF_MEAN|0.07069||0.2836|TWO_SIDED|95.0|-0.2144|0.0627|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0627|-0.2144|0.2836
74005438|NCT04908189|147560429|SUPERIORITY||Adjusted mean difference|-0.5548|STANDARD_ERROR_OF_MEAN|0.09431|<|0.0001|TWO_SIDED|95.0|-0.7396|-0.3699|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.3699|-0.7396|<0.0001
74005439|NCT04908189|147560429|SUPERIORITY||Adjusted mean difference|-0.5835|STANDARD_ERROR_OF_MEAN|0.10162|<|0.0001|TWO_SIDED|95.0|-0.7826|-0.3843|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.3843|-0.7826|<0.0001
74005440|NCT04908189|147560430|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.2143|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.1|-0.4|0.2143
74005441|NCT04908189|147560430|SUPERIORITY||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.2|-0.8|0.0001
74005442|NCT04908189|147560430|SUPERIORITY||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.4|-1.0|<0.0001
74005443|NCT04908189|147560430|SUPERIORITY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.4|-0.9|<0.0001
74005444|NCT04908189|147560433|SUPERIORITY||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|1.801||0.8316|TWO_SIDED|95.0|-3.91|3.15|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Absenteeism||3.15|-3.91|0.8316
74005445|NCT04908189|147560433|SUPERIORITY||Adjusted mean difference|-2.95|STANDARD_ERROR_OF_MEAN|1.827||0.106|TWO_SIDED|95.0|-6.54|0.63|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Presenteeism||0.63|-6.54|0.1060
74005446|NCT04908189|147560433|SUPERIORITY||Adjusted mean difference|-2.71|STANDARD_ERROR_OF_MEAN|1.918||0.1578|TWO_SIDED|95.0|-6.47|1.05|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Work Productivity||1.05|-6.47|0.1578
73878289|NCT04233801|147295776|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-20.05||||0.0003|TWO_SIDED|95.0|-30.73|-9.38|||Mixed model repeated measures|||||-9.38|-30.73|0.0003
74005447|NCT04908189|147560433|SUPERIORITY||Adjusted mean difference|-7.59|STANDARD_ERROR_OF_MEAN|1.719|<|0.0001|TWO_SIDED|95.0|-10.96|-4.22|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Activity Impairment||-4.22|-10.96|<0.0001
74005448|NCT04908189|147560434|SUPERIORITY||Adjusted mean difference|-0.0026|STANDARD_ERROR_OF_MEAN|0.01224||0.8487|TWO_SIDED|95.0|-0.0291|0.0239|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Utility Score||0.0239|-0.0291|0.8487
74005449|NCT04908189|147560434|SUPERIORITY||Adjusted mean difference|0.0365|STANDARD_ERROR_OF_MEAN|0.01531||0.0171|TWO_SIDED|95.0|0.0065|0.0665|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Utility Score||0.0665|0.0065|0.0171
74005450|NCT04908189|147560434|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9254|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Mobility||0.1|-0.1|0.9254
74005451|NCT04908189|147560434|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0566|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Mobility||0.0|-0.2|0.0566
74005452|NCT04908189|147560434|SUPERIORITY||Ajudted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.8933|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Self-Care||0.1|-0.1|0.8933
74005453|NCT04908189|147560434|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0738|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Self-Care||0.0|-0.2|0.0738
74038390|NCT03784027|147630242|SUPERIORITY||Mean Difference (Final Values)|-12.3|||<|0.001|TWO_SIDED|95.0|-14.8|-9.8||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-9.8|-14.8|<0.001
74038391|NCT03784027|147630243|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.74|TWO_SIDED|95.0|-0.4|0.5||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear|||||0.5|-0.4|0.74
74038392|NCT03784027|147630244|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|-6.2|||||TWO_SIDED|95.0|-7.6|-4.8|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||-4.8|-7.6|
74005454|NCT04908189|147560434|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.6176|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Usual Activities||0.1|-0.1|0.6176
74005455|NCT04908189|147560434|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.1544|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Usual Activities||0.0|-0.2|0.1544
74005456|NCT04908189|147560434|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.4707|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Pain/Discomfort||0.1|-0.2|0.4707
74038393|NCT03784027|147630245|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values. Differences in percents are shown in percentage points.|Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.5|0.05|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.05|-1.5|
74038394|NCT03784027|147630246|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.1|0.1||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.1|-0.1|
74005457|NCT04908189|147560434|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0114|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Pain/Discomfort||0.0|-0.3|0.0114
74005458|NCT04908189|147560434|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.6594|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Anxiety/Depression||0.1|-0.1|0.6594
73878290|NCT04233801|147295776|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-24.13|||<|0.0001|TWO_SIDED|95.0|-34.72|-13.54|||Mixed model repeated measures|||||-13.54|-34.72|<0.0001
74005459|NCT04908189|147560434|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.7123|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Anxiety/Depression||0.1|-0.1|0.7123
74005460|NCT04908189|147560435|SUPERIORITY||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.498||0.9834|TWO_SIDED|95.0|-0.99|0.97|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.97|-0.99|0.9834
74005461|NCT04908189|147560435|SUPERIORITY||Adjusted mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.565||0.6099|TWO_SIDED|95.0|-1.39|0.82|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||0.82|-1.39|0.6099
74005462|NCT04908189|147560435|SUPERIORITY||Adjusted mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.538||0.2205|TWO_SIDED|95.0|-1.71|0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||0.40|-1.71|0.2205
74005463|NCT00458341|147560455|OTHER|||||||0.133||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1||||0.133
74005464|NCT00458341|147560455|OTHER|||||||0.19||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1||||0.190
74005465|NCT00458341|147560455|OTHER|||||||0.123||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2||||0.123
74005466|NCT00458341|147560455|OTHER|||||||0.592||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2||||0.592
74005467|NCT00458341|147560456|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
74005468|NCT00458341|147560456|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
74005469|NCT00458341|147560456|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
74005470|NCT00458341|147560456|OTHER|||||||0.518|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.518
74005471|NCT05461794|147560486|OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.3|23.9|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||23.9|0.3|
74005472|NCT05461794|147560486|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-9.3|19.5|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||19.5|-9.3|
74005473|NCT05461794|147560488|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.45|1.61|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||1.61|0.45|
74005474|NCT05461794|147560489|OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|0.9|6.8|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics|||6.8|0.9|
74005475|NCT05461794|147560489|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.7|||||The odds ratio was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||3.7|0.3|
74005476|NCT05461794|147560489|OTHER||Risk Difference (RD)|22.0|||||TWO_SIDED|95.0|-1.5|43.3|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||43.3|-1.5|
74005477|NCT05461794|147560489|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-24.5|28.4|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||28.4|-24.5|
74005478|NCT05461794|147560490|OTHER||Odds Ratio (OR)|3.9|||||TWO_SIDED|95.0|0.7|40.8|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||40.8|0.7|
74005479|NCT05461794|147560490|OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.1|2.9|||||The odds ratio was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||2.9|0.1|
74005480|NCT05461794|147560490|OTHER||Risk Difference (RD)|12.7|||||TWO_SIDED|95.0|-2.3|29.5|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||29.5|-2.3|
74005481|NCT05461794|147560490|OTHER||Risk Difference (RD)|-8.4|||||TWO_SIDED|95.0|-34.7|13.8|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||13.8|-34.7|
74005482|NCT05461794|147560491|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.29|0.96|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||0.96|0.29|
74005483|NCT05461794|147560491|OTHER||Hazard Ratio (HR)|1.96|||||TWO_SIDED|95.0|0.79|4.82|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||4.82|0.79|
73878291|NCT04233801|147295777|OTHER|The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.|Adjusted mean|-56.32|||<|0.0001|TWO_SIDED|95.0|-78.22|-34.41|||ANCOVA|||||-34.41|-78.22|<0.0001
73878292|NCT04233801|147295777|OTHER|The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.|Adjusted mean|-60.71|||<|0.0001|TWO_SIDED|95.0|-82.31|-39.11|||ANCOVA|||||-39.11|-82.31|<0.0001
73878293|NCT04233801|147295778|OTHER||Odds Ratio (OR)|1.76||||0.2422|TWO_SIDED|95.0|0.68|4.55|||Regression, Logistic|Logistic regression including treatment and continuous baseline glycosylated haemoglobin A1c (HbA1c).|Odds ratio used Placebo as the reference group.|||4.55|0.68|0.2422
73878294|NCT04233801|147295778|OTHER||Odds Ratio (OR)|0.85||||0.7661|TWO_SIDED|95.0|0.29|2.5|||Regression, Logistic|Logistic regression including treatment and continuous baseline glycosylated haemoglobin A1c (HbA1c).|Odds ratio used Placebo as the reference group.|||2.50|0.29|0.7661
73878295|NCT01342913|147295783|SUPERIORITY_OR_OTHER||Least squares mean difference|0.022||||0.282|TWO_SIDED|95.0|-0.018|0.063|||ANCOVA|||||0.063|-0.018|0.282
74005484|NCT05461794|147560492|OTHER||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.1|2.7|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics|||2.7|0.1|
74005485|NCT00467285|147560494|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||comparison of changes in BMD at 6months compared to baseline||||<0.05
74005486|NCT01658826|147560540|SUPERIORITY||Risk Ratio (RR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.3|0.63|||non-linear mixed effects model|||||0.63|0.30|<0.0001
74005487|NCT03645954|147560542|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||<0.01
74005488|NCT03645954|147560543|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
74005489|NCT03645954|147560544|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
74005490|NCT03645954|147560545|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||>0.05
74005491|NCT03645954|147560546|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
74005492|NCT03645954|147560547|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||>0.05
74005493|NCT02445196|147560584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.57||||0.035|TWO_SIDED||||||ANOVA|||Repeated measures ANOVAs assessed the condition by time (baseline to posttreatment) interaction effects covarying PTSD treatment. Following the ITT principle, data from all randomized participants were analyzed and multiple imputation replaced missing values. A power analysis indicated that to achieve 80% power to detect an effect size in the magnitude (i.e., d = 0.25 to .33) with alpha of .05 and a correlation between repeated measures of .5, 60 participants per condition would be needed.||||.035
74005494|NCT02445196|147560585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.87||||0.086|TWO_SIDED||||||ANOVA|||||||.086
74005495|NCT02445196|147560586|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.007|TWO_SIDED||||||ANOVA|||||||.007
74005496|NCT02445196|147560587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.72||||0.005|TWO_SIDED||||||ANOVA|||||||.005
74005497|NCT02445196|147560588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78||||0.113|TWO_SIDED||||||t-test, 2 sided|||||||.113
74005498|NCT02072434|147560623|OTHER||Odds Ratio (OR)|0.46|||||TWO_SIDED|95.0|0.12|1.43||||||||1.43|0.12|
73878296|NCT04024891|147295790|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.7|||Mixed Models Analysis|||||-0.7|-1.3|<0.0001
73878297|NCT00599872|147295818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.418|||<|0.05|TWO_SIDED|95.0|-1.15|0.48|||ANCOVA|||||0.48|-1.15|<0.05
73878298|NCT00599872|147295819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.36|||<|0.05|TWO_SIDED|95.0|-1.72|0.63|||ANCOVA|||||0.63|-1.72|<0.05
73878299|NCT00453154|147295830|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using a 1-sided significance level of 0.15, the study has approximately 89% power to reject the null hypothesis|Hazard Ratio (HR)|1.62||||0.02|TWO_SIDED|70.0|1.27|2.08||All randomization was done using a permuted-block scheme with a block size of 6, stratified by combination chemotherapy (cisplatin vs carboplatin) and number of combination chemotherapy cycles (\< 6 vs 6 cycles)|Log Rank|||||2.08|1.27|0.02
73878300|NCT02152631|147295838|SUPERIORITY||Hazard Ratio (HR)|0.968||||0.771|TWO_SIDED|95.0|0.768|1.219|||Stratified Log-Rank||Hazard Ratio (HR) was estimated based on Stratified Cox proportional hazard model.|The stratification factors used in the analysis were: number of prior chemotherapy regimens (1 versus 2), Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) (0 versus 1), gender (male versus female), and kirsten rat sarcoma (KRAS) mutation (GLY12CYS \[G12C\] vs. all others)||1.219|0.768|0.771
73878301|NCT02152631|147295839|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|||Stratified by number of prior chemotherapy regimens (1 versus 2), ECOG PS (0 versus 1), gender (male versus female), and KRAS mutation (GLY12CYS \[G12C\] vs. all others)||||0.010
73878302|NCT02152631|147295840|SUPERIORITY||Hazard Ratio (HR)|0.583|||<|1e-06|TWO_SIDED|95.0|0.47|0.723|||Stratified Log-Rank|||||0.723|0.470|<0.000001
73878303|NCT02152631|147295841|SUPERIORITY||LS Mean Change Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.19||0.698|TWO_SIDED|95.0|-0.44|0.29|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Headache||0.29|-0.44|0.698
73878304|NCT02152631|147295841|SUPERIORITY||LS Mean Change Difference|0.59|STANDARD_ERROR_OF_MEAN|0.28||0.038|TWO_SIDED|95.0|0.03|1.15|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Diarrhea||1.15|0.03|0.038
73878305|NCT02152631|147295841|SUPERIORITY||LS Mean Change Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.94|-1.86|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Rash||-1.86|-2.94|<.001
73878306|NCT02152631|147295841|SUPERIORITY||LS Mean Change Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.16||0.142|TWO_SIDED|95.0|-0.56|0.08|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Core Symptom Severity||0.08|-0.56|0.142
74005499|NCT02072434|147560624|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.64|3.55||||||||3.55|0.64|
74005500|NCT02072434|147560625|OTHER||Difference between percentages|-0.72|||||TWO_SIDED|95.0|-1.59|0.15||||||||0.15|-1.59|
73957237|NCT04771273|147450411|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.79|||<|0.0001|TWO_SIDED|95.0|-12.85|-8.73||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.73|-12.85|<.0001
74005501|NCT02634346|147560626|SUPERIORITY||Least square mean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.83|<|0.001|TWO_SIDED|95.0|-10.0|-2.8|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-2.8|-10.0|<0.001
74005502|NCT02634346|147560626|SUPERIORITY||Least square mean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.84||0.004|TWO_SIDED|95.0|-8.9|-1.7|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-1.7|-8.9|0.004
74005503|NCT02634346|147560627|SUPERIORITY||Least square mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.118||0.002|TWO_SIDED|95.0|-0.61|-0.14|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-0.14|-0.61|0.002
74005504|NCT02634346|147560627|SUPERIORITY||Least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.118|<|0.001|TWO_SIDED|95.0|-0.67|-0.2|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-0.20|-0.67|<0.001
74005505|NCT01570036|147560629|OTHER|Kaplan-Meier Survival Analysis|Hazard Ratio (HR)|0.62||||0.18|TWO_SIDED|95.0|0.31|1.25|||Kaplan-Meier Survival Analysis|||||1.25|.31|0.18
74005506|NCT01570036|147560631|OTHER|||||||0.02||||||Comparison of the mean LVEF from baseline to 3 months, 6 months, and 12 months; this time period includes the therapy period of trastuzumab.|ANOVA|||||||0.02
74005507|NCT01570036|147560631|OTHER|||||||0.58||||||The mean LVEF compared at baseline to 3 months, 6 months, 12 months and 24 months; this time period includes the duration of trastuzumab therapy and 1 year after completion of trastuzumab therapy.|ANOVA|||||||0.58
74005508|NCT01570036|147560631|OTHER|||||||0.65||||||Evaluating LVEF at all time points with a linear mixed regression model, this analysis compared cardiac ejection fraction over time.|Regression, Linear|||||||0.65
74005509|NCT01570036|147560631|OTHER|||||||0.91||||||This analysis evaluated LVEF at all time points with a linear mixed regression model between randomization arms.|Regression, Linear|||||||0.91
74005510|NCT01570036|147560631|OTHER|||||||0.81||||||This analysis evaluated LVEF at all time points with a linear mixed regression model between the arms over time.|Regression, Linear|||||||0.81
74005511|NCT01570036|147560632|OTHER|||||||0.149|||||||Chi-squared|Comparison of the maximum related local toxicity experienced per patient and compared between treatment arms.||The safety group consisted of any patients who received NPS with GM-CSF or placebo with GM-CSF inoculations.||||0.149
74038395|NCT03784027|147630247|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-1.6|-0.6|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||-0.6|-1.6|
74005512|NCT01570036|147560632|OTHER|||||||0.901|||||||Chi-squared|Comparison of the maximum related systemic toxicity experienced per patient and compared between treatment arms.||||||0.901
74005513|NCT00568321|147560635|SUPERIORITY||LS Mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.43||0.687|TWO_SIDED|90.0|-0.5|0.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Least square (LS) mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.92|-0.50|0.687
74005514|NCT00568321|147560635|SUPERIORITY||LS Mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.44||0.111|TWO_SIDED|90.0|-1.25|0.19|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||LS mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.19|-1.25|0.111
74005515|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.41||0.399|TWO_SIDED|90.0|-0.79|0.58|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.58|-0.79|0.399
74005516|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.42||0.189|TWO_SIDED|90.0|-1.06|0.32|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.32|-1.06|0.189
74005517|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.42||0.802|TWO_SIDED|90.0|-0.33|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.33|0.802
74038396|NCT03784027|147630248|NON_INFERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-0.006|0.009|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.009|-0.006|
74005518|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.42||0.582|TWO_SIDED|90.0|-0.61|0.78|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.78|-0.61|0.582
74005519|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.42||0.789|TWO_SIDED|90.0|-0.36|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.36|0.789
74005520|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.42||0.29|TWO_SIDED|90.0|-0.94|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-0.94|0.290
74005521|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.44||0.568|TWO_SIDED|90.0|-0.65|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.65|0.568
74005522|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.45||0.116|TWO_SIDED|90.0|-1.27|0.2|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.20|-1.27|0.116
74005523|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.46||0.218|TWO_SIDED|90.0|-1.11|0.4|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.40|-1.11|0.218
74005524|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.261|TWO_SIDED|90.0|-1.06|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.06|0.261
74005525|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.48||0.252|TWO_SIDED|90.0|-1.11|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.11|0.252
74005526|NCT00568321|147560636|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.49||0.182|TWO_SIDED|90.0|-1.26|0.36|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.36|-1.26|0.182
74005527|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.39||0.683|TWO_SIDED|90.0|-0.46|0.84|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.84|-0.46|0.683
74005528|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.31|TWO_SIDED|90.0|-0.85|0.46|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.46|-0.85|0.310
74005529|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.37||0.668|TWO_SIDED|90.0|-0.46|0.78|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.78|-0.46|0.668
74005530|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.38||0.165|TWO_SIDED|90.0|-0.99|0.26|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.26|-0.99|0.165
74005531|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.36||0.546|TWO_SIDED|90.0|-0.55|0.64|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.64|-0.55|0.546
74005532|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.36||0.19|TWO_SIDED|90.0|-0.92|0.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.28|-0.92|0.190
74005533|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.35||0.467|TWO_SIDED|90.0|-0.6|0.55|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.55|-0.60|0.467
74038397|NCT03784027|147630249|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.75|TWO_SIDED|95.0|-0.02|0.03|||Regression, Linear|Based on a longitudinal model adjusting for baseline value and period as fixed effects. The model accounts for correlated data from the same subject.||||0.03|-0.02|0.75
74005534|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.35||0.153|TWO_SIDED|90.0|-0.94|0.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.22|-0.94|0.153
74005535|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.41||0.632|TWO_SIDED|90.0|-0.54|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.54|0.632
74005536|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.41||0.094|TWO_SIDED|90.0|-1.22|0.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.14|-1.22|0.094
74005537|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.39||0.468|TWO_SIDED|90.0|-0.68|0.61|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.61|-0.68|0.468
74005538|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.39||0.167|TWO_SIDED|90.0|-1.03|0.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.27|-1.03|0.167
74005539|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.37||0.394|TWO_SIDED|90.0|-0.72|0.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.52|-0.72|0.394
74005540|NCT00568321|147560637|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.38||0.138|TWO_SIDED|90.0|-1.04|0.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.21|-1.04|0.138
74005541|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.55||0.764|TWO_SIDED|90.0|-0.51|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.51|0.764
74005542|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.55||0.75|TWO_SIDED|90.0|-0.54|1.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.28|-0.54|0.750
74005543|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.45||0.734|TWO_SIDED|90.0|-0.46|1.03|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.03|-0.46|0.734
74005544|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.45||0.514|TWO_SIDED|90.0|-0.73|0.77|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.77|-0.73|0.514
74005545|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|1.37|STANDARD_ERROR_OF_MEAN|1.89||0.765|TWO_SIDED|90.0|-1.76|4.5|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.50|-1.76|0.765
74005546|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|1.9||0.646|TWO_SIDED|90.0|-2.43|3.86|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.86|-2.43|0.646
74005547|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.55||0.895|TWO_SIDED|90.0|-0.22|1.6|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.60|-0.22|0.895
74038398|NCT03784027|147630250|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.1|0.8|||||(For total daily insulin use) Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.8|-0.1|
74038399|NCT05263921|147630275|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|107.35|||||TWO_SIDED|90.0|99.66|115.64||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||115.64|99.66|
74005548|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.56||0.776|TWO_SIDED|90.0|-0.5|1.34|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.34|-0.50|0.776
74005549|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.45||0.944|TWO_SIDED|90.0|-0.03|1.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.47|-0.03|0.944
74005550|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.46||0.835|TWO_SIDED|90.0|-0.31|1.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.21|-0.31|0.835
74005551|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|3.23|STANDARD_ERROR_OF_MEAN|1.9||0.955|TWO_SIDED|90.0|0.09|6.37|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||6.37|0.09|0.955
74005552|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.93||0.884|TWO_SIDED|90.0|-0.88|5.49|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||5.49|-0.88|0.884
74005553|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.56||0.737|TWO_SIDED|90.0|-0.57|1.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.28|-0.57|0.737
74005554|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.56||0.628|TWO_SIDED|90.0|-0.74|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-0.74|0.628
74005555|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.67|STANDARD_ERROR_OF_MEAN|0.46||0.925|TWO_SIDED|90.0|-0.1|1.43|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.43|-0.10|0.925
74005556|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.46||0.518|TWO_SIDED|90.0|-0.75|0.79|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.79|-0.75|0.518
74005557|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.93||0.81|TWO_SIDED|90.0|-1.49|4.88|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.88|-1.49|0.810
74005558|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.94||0.6|TWO_SIDED|90.0|-2.72|3.7|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.70|-2.72|0.600
74005559|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.58||0.651|TWO_SIDED|90.0|-0.73|1.18|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.18|-0.73|0.651
74005560|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.59||0.342|TWO_SIDED|90.0|-1.21|0.73|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.73|-1.21|0.342
74005561|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.768|TWO_SIDED|90.0|-0.44|1.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.14|-0.44|0.768
74005562|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.48||0.211|TWO_SIDED|90.0|-1.19|0.41|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.41|-1.19|0.211
74038400|NCT05263921|147630275|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|120.73|||||TWO_SIDED|90.0|112.09|130.03||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||130.03|112.09|
73878307|NCT02152631|147295841|SUPERIORITY||LS Mean Change Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.514|TWO_SIDED|95.0|-0.59|0.3|||Mixed Models Analysis|Analyzed by Type 3 sums of square, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Interference||0.30|-0.59|0.514
74005563|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.99||0.61|TWO_SIDED|90.0|-2.73|3.85|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.85|-2.73|0.610
74005564|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|2.02||0.241|TWO_SIDED|90.0|-4.76|1.91|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.91|-4.76|0.241
74005565|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.59||0.789|TWO_SIDED|90.0|-0.5|1.45|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.45|-0.50|0.789
74005566|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.6||0.57|TWO_SIDED|90.0|-0.88|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.88|0.570
74005567|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|0.49||0.782|TWO_SIDED|90.0|-0.43|1.19|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.19|-0.43|0.782
74005568|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.49||0.295|TWO_SIDED|90.0|-1.08|0.55|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.55|-1.08|0.295
74005569|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|1.75|STANDARD_ERROR_OF_MEAN|2.04||0.804|TWO_SIDED|90.0|-1.62|5.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||5.11|-1.62|0.804
74005570|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|2.06||0.655|TWO_SIDED|90.0|-2.58|4.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.22|-2.58|0.655
74038401|NCT05263921|147630275|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|125.04|||||TWO_SIDED|90.0|116.08|134.69||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||134.69|116.08|
74005571|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.6||0.409|TWO_SIDED|90.0|-1.13|0.86|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.86|-1.13|0.409
74005572|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.61||0.482|TWO_SIDED|90.0|-1.03|0.97|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.97|-1.03|0.482
74005573|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.5||0.592|TWO_SIDED|90.0|-0.71|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-0.71|0.592
74038402|NCT05263921|147630276|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|108.8|||||TWO_SIDED|90.0|101.06|117.14||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||117.14|101.06|
74038403|NCT05263921|147630276|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|120.95|||||TWO_SIDED|90.0|112.36|130.2||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||130.20|112.36|
74038404|NCT05263921|147630276|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|127.39|||||TWO_SIDED|90.0|118.32|137.15||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||137.15|118.32|
73878308|NCT02152631|147295841|SUPERIORITY||LS Mean Change Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.646|TWO_SIDED|95.0|-0.37|0.23|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Lung Cancer||0.23|-0.37|0.646
73878309|NCT02152631|147295841|SUPERIORITY||LS Mean Change Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.188|TWO_SIDED|95.0|-0.51|0.1|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Core Plus Lung Cancer||0.10|-0.51|0.188
74005574|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.5||0.368|TWO_SIDED|90.0|-1.0|0.66|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.66|-1.00|0.368
74005575|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|2.08||0.396|TWO_SIDED|90.0|-3.98|2.88|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.88|-3.98|0.396
74005576|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|2.09||0.545|TWO_SIDED|90.0|-3.21|3.69|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.69|-3.21|0.545
74005577|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.62||0.486|TWO_SIDED|90.0|-1.04|1.0|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.00|-1.04|0.486
74005578|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.63||0.324|TWO_SIDED|90.0|-1.33|0.75|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.75|-1.33|0.324
74005579|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.51||0.563|TWO_SIDED|90.0|-0.76|0.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.92|-0.76|0.563
74005580|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.52||0.282|TWO_SIDED|90.0|-1.16|0.56|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.56|-1.16|0.282
74005581|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|2.12||0.409|TWO_SIDED|90.0|-3.99|3.01||P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.|Repeated Measures Model|||Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.01|-3.99|0.409
74038405|NCT05263921|147630277|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|115.1|||||TWO_SIDED|90.0|104.03|127.34||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||127.34|104.03|
74038406|NCT05263921|147630277|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|145.6|||||TWO_SIDED|90.0|131.68|160.99||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||160.99|131.68|
74005582|NCT00568321|147560638|SUPERIORITY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|2.17||0.293|TWO_SIDED|90.0|-4.76|2.39||P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.|Repeated Measures Model|||Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.39|-4.76|0.293
74005583|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.343|TWO_SIDED|90.0|-1.03|0.62|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.62|-1.03|0.343
74005584|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.576|TWO_SIDED|90.0|-0.75|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-0.75|0.576
74005585|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.63||0.46|TWO_SIDED|90.0|-1.1|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-1.10|0.460
74038407|NCT05263921|147630277|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|161.48|||||TWO_SIDED|90.0|145.95|178.66||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||178.66|145.95|
74038408|NCT05263921|147630278|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|110.85|||||TWO_SIDED|90.0|95.38|128.82||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||128.82|95.38|
74005586|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.435|TWO_SIDED|90.0|-1.15|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-1.15|0.435
74005587|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.56||0.104|TWO_SIDED|90.0|-1.62|0.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.22|-1.62|0.104
74005588|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.57||0.204|TWO_SIDED|90.0|-1.42|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.42|0.204
74005589|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.5||0.931|TWO_SIDED|90.0|-0.08|1.58|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.58|-0.08|0.931
74005590|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.52||0.941|TWO_SIDED|90.0|-0.04|1.67|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.67|-0.04|0.941
74005591|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.63||0.936|TWO_SIDED|90.0|-0.08|2.01|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.01|-0.08|0.936
74005592|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|0.64||0.965|TWO_SIDED|90.0|0.11|2.23|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.23|0.11|0.965
74005593|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.56||0.855|TWO_SIDED|90.0|-0.33|1.51|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.51|-0.33|0.855
74005594|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.58||0.765|TWO_SIDED|90.0|-0.54|1.38|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.38|-0.54|0.765
74005595|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.51||0.504|TWO_SIDED|90.0|-0.84|0.85|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.85|-0.84|0.504
74038409|NCT05263921|147630278|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|106.55|||||TWO_SIDED|90.0|91.76|123.73||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||123.73|91.76|
74038410|NCT05263921|147630278|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.74|||||TWO_SIDED|90.0|92.7|125.21||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||125.21|92.70|
74005596|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.52||0.643|TWO_SIDED|90.0|-0.67|1.06|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.06|-0.67|0.643
74005597|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.64||0.486|TWO_SIDED|90.0|-1.09|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-1.09|0.486
74005598|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.65||0.6|TWO_SIDED|90.0|-0.91|1.24|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.24|-0.91|0.600
74038411|NCT05263921|147630279|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|110.19|||||TWO_SIDED|90.0|94.51|128.47||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||128.47|94.51|
74038412|NCT05263921|147630279|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.17|||||TWO_SIDED|90.0|92.0|124.86||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||124.86|92.00|
74005599|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.57||0.418|TWO_SIDED|90.0|-1.05|0.82|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.82|-1.05|0.418
74005600|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.59||0.515|TWO_SIDED|90.0|-0.95|0.99|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.99|-0.95|0.515
74005601|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.53||0.456|TWO_SIDED|90.0|-0.93|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.93|0.456
74005602|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.54||0.556|TWO_SIDED|90.0|-0.82|0.97|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.97|-0.82|0.556
74005603|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.67||0.448|TWO_SIDED|90.0|-1.19|1.02|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.02|-1.19|0.448
74005604|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.68||0.6|TWO_SIDED|90.0|-0.95|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.95|0.600
74005605|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.59||0.225|TWO_SIDED|90.0|-1.41|0.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.52|-1.41|0.225
74005606|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.61||0.387|TWO_SIDED|90.0|-1.18|0.83|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.83|-1.18|0.387
74005607|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.54||0.657|TWO_SIDED|90.0|-0.67|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-0.67|0.657
74005608|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.55||0.808|TWO_SIDED|90.0|-0.43|1.4|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.40|-0.43|0.808
74005609|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.68||0.742|TWO_SIDED|90.0|-0.68|1.57|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.57|-0.68|0.742
74005610|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|0.7||0.923|TWO_SIDED|90.0|-0.16|2.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.14|-0.16|0.923
74005611|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.6||0.49|TWO_SIDED|90.0|-1.01|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-1.01|0.490
74005612|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.62||0.609|TWO_SIDED|90.0|-0.86|1.2|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.20|-0.86|0.609
74005613|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.55||0.362|TWO_SIDED|90.0|-1.1|0.71|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.71|-1.10|0.362
74005614|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.56||0.61|TWO_SIDED|90.0|-0.77|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.77|0.610
74091024|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.27|STANDARD_ERROR_OF_MEAN|3.6471|||TWO_SIDED|95.0|-7.0|7.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.5|-7.0|
74091025|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.27|STANDARD_ERROR_OF_MEAN|3.5708|||TWO_SIDED|95.0|-9.4|4.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.8|-9.4|
74005615|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.7||0.376|TWO_SIDED|90.0|-1.37|0.93|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.93|-1.37|0.376
73878310|NCT02152631|147295843|SUPERIORITY||LS Mean Change Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.951|TWO_SIDED|95.0|-0.05|0.05|||Mixed Models Analysis|Analyzed By Type 3 sums of squares, Change from Baseline = Treatment + Visit + Treatment\*Visit + Baseline.||||0.05|-0.05|0.951
74091026|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.21|STANDARD_ERROR_OF_MEAN|3.6602|||TWO_SIDED|95.0|-11.5|3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.1|-11.5|
74005616|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.71||0.733|TWO_SIDED|90.0|-0.73|1.6|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.60|-0.73|0.733
74005617|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.61||0.303|TWO_SIDED|90.0|-1.33|0.69|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.69|-1.33|0.303
74091027|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54|STANDARD_ERROR_OF_MEAN|4.1389|||TWO_SIDED|95.0|-7.7|8.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||8.8|-7.7|
74091028|NCT02037165|147735943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.04|STANDARD_ERROR_OF_MEAN|3.3835|||TWO_SIDED|95.0|-8.8|4.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.7|-8.8|
74091029|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-29.67|STANDARD_ERROR_OF_MEAN|29.5691|||TWO_SIDED|95.0|-88.3|29.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||29.0|-88.3|
73878311|NCT03776747|147295856|OTHER|Analysis of variance between lung inflation levels|||||<|0.001|||||||ANOVA|||We hypothesized that the anisotropic deformation index (ADC) is dependent upon lung inflation level. (Thus, it is important to standardize lung inflation when using this method)||||<0.001
73878312|NCT01693029|147295859|EQUIVALENCE|"Equivalence margin (-0.5, 0.5) g/dL. Results from ANCOVA with factors treatment group and covariates mean baseline Hb and mean weekly dose during the evaluation period (Week 21-28)"|Mean Difference (Final Values)|-0.0926|||||TWO_SIDED|90.0|-0.2264|0.0413|||||||95% confidence interval for the difference is (-0.2522, 0.0670).|0.0413|-0.2264|
74005618|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.63||0.548|TWO_SIDED|90.0|-0.97|1.12|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.12|-0.97|0.548
73878313|NCT02210000|147295914|SUPERIORITY||Median Difference (Net)|-0.212||||0.017|TWO_SIDED|95.0|-0.3716|-0.0448||Posterior probability of the treatment difference in response rate at Week 12 being greater than 0%.|Bayesian method|||||-0.0448|-0.3716|0.017
74005619|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.56||0.609|TWO_SIDED|90.0|-0.77|1.08|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.08|-0.77|0.609
74005620|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.59||0.59|TWO_SIDED|90.0|-0.83|1.1|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.10|-0.83|0.590
74005621|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.71||0.556|TWO_SIDED|90.0|-1.07|1.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.27|-1.07|0.556
74005622|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.73||0.443|TWO_SIDED|90.0|-1.32|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-1.32|0.443
74005623|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.62||0.527|TWO_SIDED|90.0|-0.99|1.07|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.07|-0.99|0.527
74005624|NCT00568321|147560645|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.66||0.583|TWO_SIDED|90.0|-0.95|1.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.22|-0.95|0.583
74005625|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.63||0.111|TWO_SIDED|90.0|-1.81|0.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.27|-1.81|0.111
74005626|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.64||0.523|TWO_SIDED|90.0|-1.02|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-1.02|0.523
74005627|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|0.77|STANDARD_ERROR_OF_MEAN|0.63||0.887|TWO_SIDED|90.0|-0.28|1.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.81|-0.28|0.887
74005628|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.65||0.903|TWO_SIDED|90.0|-0.23|1.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.92|-0.23|0.903
74005629|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.64||0.472|TWO_SIDED|90.0|-1.11|1.02|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.02|-1.11|0.472
74005630|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.66||0.628|TWO_SIDED|90.0|-0.87|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.87|0.628
74005631|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.67||0.243|TWO_SIDED|90.0|-1.58|0.64|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.64|-1.58|0.243
73878314|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.2353|0.6553|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.6553|-0.2353|
73878315|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.749|||||TWO_SIDED|95.0|0.2275|1.2705|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Feeling full after meals at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||1.2705|0.2275|
73878316|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.489|||||TWO_SIDED|95.0|-0.0592|1.0374|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||1.0374|-0.0592|
73878317|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.497|||||TWO_SIDED|95.0|0.0396|0.955|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Not able to finish meal at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9550|0.0396|
74005632|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.69||0.346|TWO_SIDED|90.0|-1.42|0.87|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.87|-1.42|0.346
74005633|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.69||0.467|TWO_SIDED|90.0|-1.19|1.08|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.08|-1.19|0.467
74005634|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.7||0.67|TWO_SIDED|90.0|-0.85|1.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.47|-0.85|0.670
74005635|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.7||0.286|TWO_SIDED|90.0|-1.55|0.76|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.76|-1.55|0.286
74005636|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.71||0.598|TWO_SIDED|90.0|-1.0|1.35|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.35|-1.00|0.598
74005637|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.71||0.453|TWO_SIDED|90.0|-1.26|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-1.26|0.453
74038413|NCT05263921|147630279|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.83|||||TWO_SIDED|90.0|92.48|125.72||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||125.72|92.48|
74038414|NCT05263921|147630280|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|108.72|||||TWO_SIDED|90.0|89.32|132.32||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||132.32|89.32|
74038415|NCT05263921|147630280|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.44|||||TWO_SIDED|90.0|90.05|133.0||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||133.00|90.05|
74038416|NCT05263921|147630280|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|117.3|||||TWO_SIDED|90.0|96.37|142.77||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||142.77|96.37|
74038417|NCT00915538|147630293|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The expected results for non-inferiority would be +/- 5% of difference between the two groups in the primary efficacy parameter.|AUC|0.0||||0.76|TWO_SIDED||||||t-test, 2 sided|||The cross-over means there were 16 determinants for each time for each treatment. The AUC of FEV-1 was measured in each subject for each treatment arm and the mean of this data was compared.||||0.76
74038418|NCT00915538|147630293|OTHER|Two sample T test|Mean Difference (Net)|0.0|STANDARD_DEVIATION|12.0|>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
74038419|NCT00915538|147630294|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power calculation was not done for secondary parameter. The comparison was for the FEV-1/FVC expressed as fraction at each time point||||||0.76|TWO_SIDED|95.0|||||t-test, 2 sided|||The cross over means there were 16 determinants for each time for each treatment||||0.76
73878318|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.3386|0.4395|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Retching at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.4395|-0.3386|
73878319|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|-0.038|||||TWO_SIDED|95.0|-0.3242|0.2492|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Vomiting at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.2492|-0.3242|
74005638|NCT00568321|147560648|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.74||0.472|TWO_SIDED|90.0|-1.28|1.17|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.17|-1.28|0.472
74005639|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|1.02||0.548|TWO_SIDED|90.0|-1.81|1.56|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.56|-1.81|0.548
74005640|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|1.24|STANDARD_ERROR_OF_MEAN|1.04||0.117|TWO_SIDED|90.0|-0.48|2.96|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.96|-0.48|0.117
74005641|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|1.11||0.779|TWO_SIDED|90.0|-2.69|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-2.69|0.779
74005642|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|1.14||0.375|TWO_SIDED|90.0|-1.52|2.25|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.25|-1.52|0.375
74005643|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|1.15||0.881|TWO_SIDED|90.0|-3.26|0.54|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.54|-3.26|0.881
74005644|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|1.17||0.636|TWO_SIDED|90.0|-2.33|1.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.52|-2.33|0.636
74005645|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.17||0.905|TWO_SIDED|90.0|-3.46|0.39|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.39|-3.46|0.905
74005646|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.21||0.499|TWO_SIDED|90.0|-2.0|2.0|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.00|-2.00|0.499
74005647|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.5||0.297|TWO_SIDED|90.0|-0.56|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.56|0.297
74005648|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|0.91|STANDARD_ERROR_OF_MEAN|0.5||0.035|TWO_SIDED|90.0|0.09|1.74|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.74|0.09|0.035
74038420|NCT01093755|147630352|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months||||0.30
74038421|NCT01093755|147630352|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months||||0.52
74038422|NCT01093755|147630353|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months||||0.70
74038423|NCT01093755|147630353|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months||||0.64
74038424|NCT00868166|147630354|SUPERIORITY|||||||0.71|||||||Stratified Log-Rank Test|||||||0.71
74038425|NCT00868166|147630355|SUPERIORITY|||||||0.83|||||||Stratified Log-Rank Test|||||||0.83
74038426|NCT00868166|147630355|SUPERIORITY|||||||0.73|||||||Non-stratified Log-Rank Test|||||||0.73
74038427|NCT00868166|147630357|SUPERIORITY|||||||0.21|||||||Stratified Log-Rank Test|||||||0.21
74038428|NCT00868166|147630357|SUPERIORITY|||||||0.2|||||||Non-stratified Log-Rank Test|||||||0.20
74038429|NCT00868166|147630359|SUPERIORITY|||||||0.56|||||||Stratified Log-Rank Test|||||||0.56
74038430|NCT00074802|147630365|SUPERIORITY||Mean Difference (Net)|-5.43||||0.267|TWO_SIDED|95.0|-15.05|4.19|||Mixed Models Analysis|||||4.19|-15.05|.267
74038431|NCT00074802|147630366|SUPERIORITY|||||||0.018||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of responder status.||||.018
74038432|NCT00074802|147630366|SUPERIORITY|||||||0.034||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of remitter status.||||.034
74038433|NCT00074802|147630367|SUPERIORITY||Mean Difference (Net)|-3.21||||0.0005|TWO_SIDED|95.0|-5.02|-1.39|||Mixed Models Analysis|||||-1.39|-5.02|.0005
74038434|NCT00074802|147630368|SUPERIORITY||Mean Difference (Net)|-5.61||||0.0775|TWO_SIDED|95.0|-11.84|0.62|||Mixed Models Analysis|||||0.62|-11.84|.0775
74005649|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.54||0.222|TWO_SIDED|90.0|-0.48|1.31|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.31|-0.48|0.222
74005650|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.54||0.069|TWO_SIDED|90.0|-0.09|1.7|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.70|-0.09|0.069
74005651|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.55||0.338|TWO_SIDED|90.0|-0.68|1.15|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.15|-0.68|0.338
74005652|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.56||0.381|TWO_SIDED|90.0|-0.75|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.75|0.381
74005653|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.56||0.306|TWO_SIDED|90.0|-0.64|1.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.21|-0.64|0.306
74005654|NCT00568321|147560662|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.58||0.44|TWO_SIDED|90.0|-0.87|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.87|0.440
74005655|NCT02175004|147560677|SUPERIORITY||Least Squares Mean Difference|-17.84|||<|0.001|TWO_SIDED|95.0|-26.12|-9.56||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS+7 Composite Score at Week 78||-9.56|-26.12|<0.001
74005656|NCT02175004|147560677|SUPERIORITY||Least Squares Mean Difference|-20.11|||<|0.001|TWO_SIDED|95.0|-31.27|-8.95||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS+7 Composite Score at Week 156||-8.95|-31.27|<0.001
74005657|NCT02175004|147560678|SUPERIORITY||Least Squares Mean Difference|-0.06||||0.638|TWO_SIDED|95.0|-0.32|0.2||P-value=MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heart Rate to Deep Breathing Score at Week 78||0.20|-0.32|0.638
74038435|NCT00074802|147630369|SUPERIORITY||Mean Difference (Net)|-5.53||||0.0006|TWO_SIDED|95.0|-8.7|-2.35|||Mixed Models Analysis||Paroxetine+CBT \> Paroxetine alone in BFNE change.|||-2.35|-8.70|.0006
74038436|NCT00074802|147630370|SUPERIORITY||Mean Difference (Net)|0.2||||0.871|TWO_SIDED|95.0|-2.16|2.55|||Mixed Models Analysis|||||2.55|-2.16|.871
74038437|NCT00074802|147630371|SUPERIORITY||Median Difference (Net)|0.41||||0.949|TWO_SIDED|95.0|-11.95|12.76|||Mixed Models Analysis|||||12.76|-11.95|.949
74038438|NCT00654953|147630372|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|degrees of freedom for medication group = 2 (group)||The analysis tested the null hypothesis of no difference among groups in terms of the # of days to relapse (first two conseqcutively positive urines) using ANOVA.||||0.05
74038439|NCT01231607|147630373|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|22.0||||0.046|TWO_SIDED|98.33|-4.4|48.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.02 mg LS mean minus the placebo LS mean.|||48.4|-4.4|0.046
74038440|NCT01231607|147630373|SUPERIORITY_OR_OTHER||LS mean difference|67.9|||<|0.001|TWO_SIDED|98.33|41.6|94.2|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.1 mg LS mean minus the placebo LS mean.|||94.2|41.6|<0.001
74038441|NCT01231607|147630373|SUPERIORITY_OR_OTHER||LS mean difference|94.4|||<|0.001|TWO_SIDED|98.33|67.8|121.0|||General linear model|Each dose of dutasteride independently analyzed for comparison against placebo using a general linear model.|Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.5 mg LS mean minus the placebo LS mean.|||121.0|67.8|<0.001
74038442|NCT01231607|147630373|SUPERIORITY_OR_OTHER||Least squares mean difference|61.4|||<|0.001|TWO_SIDED|98.33|34.4|88.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the placebo LS mean.|||88.4|34.4|<0.001
74039858|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2264|TWO_SIDED|95.0|-0.48|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.48|0.2264
73878320|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-0.0483|0.9978|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach visibly larger at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9978|-0.0483|
73878321|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.461|||||TWO_SIDED|95.0|-0.0519|0.9748|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach fullness at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9748|-0.0519|
73878322|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.536|||||TWO_SIDED|95.0|0.0967|0.9745|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Loss of appetite at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9745|0.0967|
73878323|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.196|||||TWO_SIDED|95.0|-0.2746|0.6671|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal pain at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.6671|-0.2746|
73957238|NCT04771273|147450411|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.86|||<|0.0001|TWO_SIDED|95.0|-13.0|-8.73||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.73|-13.00|<.0001
74005658|NCT02175004|147560678|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.965|TWO_SIDED|95.0|-0.3|0.29||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heart Rate to Deep Breathing Score at Week 156||0.29|-0.30|0.965
74005659|NCT02175004|147560679|SUPERIORITY||Least Squares Mean Difference|-1.09|||<|0.001|TWO_SIDED|95.0|-1.68|-0.5||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Nerve Conduction Score at Week 78||-0.50|-1.68|<0.001
74005660|NCT02175004|147560679|SUPERIORITY||Least Squares Mean Difference|-0.66||||0.067|TWO_SIDED|95.0|-1.38|0.05||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Nerve Conduction Score at Week 156||0.05|-1.38|0.067
74005661|NCT02175004|147560680|SUPERIORITY||Least Squares Mean Difference|0.34||||0.821|TWO_SIDED|95.0|-2.67|3.36||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heat-Pain Sensory Score at Week 78||3.36|-2.67|0.821
74005662|NCT02175004|147560680|SUPERIORITY||Least Squares Mean Difference|-2.16||||0.293|TWO_SIDED|95.0|-6.21|1.9||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heat-Pain Sensory Score at Week 156||1.90|-6.21|0.293
74005663|NCT02175004|147560681|SUPERIORITY||Least Squares Mean Difference|-2.78||||0.047|TWO_SIDED|95.0|-5.53|-0.03||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Touch-Pressure Sensory Score at Week 78||-0.03|-5.53|0.047
74038443|NCT01231607|147630373|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|-39.4|||<|0.001||99.165|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.|||-12.7|-66.1|<0.001
74039859|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.0961|TWO_SIDED|95.0|-0.56|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.56|0.0961
73878324|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.314|||||TWO_SIDED|95.0|-0.2013|0.8292|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal discomfort at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.8292|-0.2013|
74091030|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-16.29|STANDARD_ERROR_OF_MEAN|29.8613|||TWO_SIDED|95.0|-75.5|42.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||42.9|-75.5|
74091031|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|7.63|STANDARD_ERROR_OF_MEAN|25.1035|||TWO_SIDED|95.0|-42.2|57.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||57.5|-42.2|
74091032|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-20.47|STANDARD_ERROR_OF_MEAN|23.311|||TWO_SIDED|95.0|-66.7|25.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||25.8|-66.7|
74091033|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-12.63|STANDARD_ERROR_OF_MEAN|23.1894|||TWO_SIDED|95.0|-58.6|33.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||33.4|-58.6|
74091034|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|23.7285|||TWO_SIDED|95.0|-47.8|46.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||46.5|-47.8|
74091035|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-19.27|STANDARD_ERROR_OF_MEAN|27.6359|||TWO_SIDED|95.0|-74.3|35.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||35.7|-74.3|
74005664|NCT02175004|147560681|SUPERIORITY||Least Squares Mean Difference|-3.07||||0.041|TWO_SIDED|95.0|-6.0|-0.13||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Touch-Pressure Sensory Score at Week 156||-0.13|-6.00|0.041
73878325|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.384|||||TWO_SIDED|95.0|-0.0323|0.7997|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Overall severity of your GP symptoms at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.7997|-0.0323|
74005665|NCT02175004|147560682|OTHER||Least Squares Mean Difference|-17.48|||<|0.001|TWO_SIDED|95.0|-26.92|-8.03||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the NIS Composite Score at Week 52 of Year 4||-8.03|-26.92|<0.001
74005666|NCT02175004|147560683|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.941|TWO_SIDED|95.0|-0.19|0.17||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Cranial Nerves Score Score at Week 52 of Year 4||0.17|-0.19|0.941
74005667|NCT02175004|147560684|SUPERIORITY||Least Squares Mean Difference|-9.56||||0.011|TWO_SIDED|95.0|-16.97|-2.16||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Muscle Weakness Score at Week 52 of Years 4||-2.16|-16.97|0.011
74005668|NCT02175004|147560685|SUPERIORITY||Least Squares Mean Difference|-1.05||||0.356|TWO_SIDED|95.0|-3.28|1.18||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Reflexes Score at Week 52 of Years 4||1.18|-3.28|0.356
73878326|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.068|||||TWO_SIDED|95.0|-0.2366|0.3723|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea/Vomiting Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.3723|-0.2366|
73878327|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.548|||||TWO_SIDED|95.0|0.1333|0.9628|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Fullness/Early Satiety Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9628|0.1333|
73878328|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.479|||||TWO_SIDED|95.0|-0.0386|0.9966|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9966|-0.0386|
74005669|NCT02175004|147560686|SUPERIORITY||Least Squares Mean Difference|-5.38|||<|0.001|TWO_SIDED|95.0|-8.58|-2.19||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Sensory Score at Week 52 of Years 4||-2.19|-8.58|<0.001
74005670|NCT02175004|147560687|SUPERIORITY||Least Squares Mean Difference|-9.31||||0.026|TWO_SIDED|95.0|-17.48|-1.14||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 78||-1.14|-17.48|0.026
74005671|NCT02175004|147560687|SUPERIORITY||Least Squares Mean Difference|-7.4||||0.107|TWO_SIDED|95.0|-16.41|1.62||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 156||1.62|-16.41|0.107
74005672|NCT02175004|147560687|SUPERIORITY||Least Squares Mean Difference|-2.72||||0.669|TWO_SIDED|95.0|-15.22|9.77||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 52 of Year 4||9.77|-15.22|0.669
74005673|NCT02175004|147560688|SUPERIORITY||Least Squares Mean Difference|-6.3||||0.097|TWO_SIDED|95.0|-13.75|1.15||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Change From CS2 Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 78||1.15|-13.75|0.097
74005674|NCT02175004|147560688|SUPERIORITY||Least Squares Mean Difference|-8.89||||0.081|TWO_SIDED|95.0|-18.88|1.11||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the Norfolk QoL-DN Physical Functioning/Large Fiber Neuropathy Domain Score at Week 156||1.11|-18.88|0.081
74005675|NCT02175004|147560688|SUPERIORITY||Least Squares Mean Difference|-11.87||||0.171|TWO_SIDED|95.0|-28.89|5.16||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Physical Functioning/Large Fiber Neuropathy Domain Score at Week 52 of Year 4||5.16|-28.89|0.171
74005676|NCT00221195|147560710|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||The Wilcoxin signed-rank test was used to compare the frequency of bleeds between the prophylaxis and on-demand periods.||||<0.001
74005677|NCT00823901|147560711|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
74038444|NCT01231607|147630373|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|6.5||||0.28||99.165|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.|||33.1|-20.1|0.28
74005678|NCT01369511|147560712|SUPERIORITY_OR_OTHER|||||||0.527|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.527
73878329|NCT02210000|147295915|SUPERIORITY||Mean Difference (Net)|0.356|||||TWO_SIDED|95.0|-0.0049|0.7179|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Total GCSI-DD at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.7179|-0.0049|
73878330|NCT00833040|147295943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.3|STANDARD_ERROR_OF_MEAN|4.49|<|0.001||95.0|||||ANCOVA|||difference between the active and placebo groups||||<0.001
74005679|NCT01369511|147560712|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.291
74005680|NCT01369511|147560712|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.129
74005681|NCT01369511|147560713|SUPERIORITY_OR_OTHER|||||||0.751|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.751
74005682|NCT01369511|147560713|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.066
74005683|NCT01369511|147560713|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.031
74005684|NCT01369511|147560713|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.315
74005685|NCT01369511|147560713|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.002
74005686|NCT01369511|147560713|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.007
74005687|NCT01376349|147560725|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
74005688|NCT01376349|147560725|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
74005689|NCT01106014|147560751|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|99.0|0.46|0.78||one-sided p-value|Log Rank|||The primary analysis was performed on the Full Analysis Set by a one-sided unstratified log-rank test||0.78|0.46|<0.0001
74005690|NCT01106014|147560752|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|12.0||||0.0027|TWO_SIDED|99.0|1.0|24.0||One-sided p-value of the nonparametric ANCOVA, adjusted for 6-minute walk distance at baseline|ANCOVA||Point estimate and 2-sided 99% CI for location shift using the HodgesLehmann method|Non-parametric ANCOVA with 6MWD as covariate at baseline. Missing values were imputed based on the following imputation rules: 1) if patient was unable to walk at week 26, 0 meter was imputed, 2) if rule 1 did not apply, the second lowest observed 6MWD value (10 meters) at Week 26 was imputed. Missing values were imputed for 21.6% of the subjects.||24|1|0.0027
74005691|NCT01106014|147560753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|It was assumed that the probabilities for absence of worsening in WHO FC at Week 26 were the same for both treatment groups|Odds Ratio, log|1.161||||0.2843|TWO_SIDED|99.0|0.811|1.664||Cochran-Mantel-Haenszel test stratified by WHO FC at baseline. For patients with missing NYHA/WHO FC at Week 26, the NYHA/WHO FC is considered as having worsened from baseline at Week 26. Missing values were imputed for 18.3% of subjects .|Cochran-Mantel-Haenszel|||||1.664|0.811|0.2843
74005692|NCT00784693|147560763|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|90.0|-0.87|1.69||||||Week 8: Analysis was based on analysis of co-variance (ANCOVA) model with main effects of treatment, contraceptive use and baseline severity of pain.||1.69|-0.87|
74005693|NCT02260882|147560794|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 3. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
74005694|NCT02260882|147560794|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 6B. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
74091036|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-25.23|STANDARD_ERROR_OF_MEAN|27.5524|||TWO_SIDED|95.0|-79.9|29.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||29.5|-79.9|
74005695|NCT02260882|147560794|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 23F. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
74005696|NCT02119325|147560804|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|-4.64||||0.0487|TWO_SIDED|95.0|-9.26|-0.03||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial glucose peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with glucose as dependent variable, treatment and period as fixed effects and subject as random effect."||-0.03|-9.26|0.0487
74005697|NCT02119325|147560805|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|-6.79||||0.6116|TWO_SIDED|95.0|-34.02|20.44||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial triglyceride peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with triglyceride as dependent variable, treatment and period as fixed effects and subject as random effect."||20.44|-34.02|0.6116
74005698|NCT01372410|147560877|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Day 8 analysis.|Wald Test|||||||<0.0001
74005699|NCT01372410|147560877|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Pooled Day 7 and 8 analysis.|Wald Test|||||||<0.0001
74005700|NCT01372410|147560878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|||<|0.001|TWO_SIDED|95.0|0.058|0.168|||Mixed Models Analysis|||||0.168|0.058|<0.001
74005701|NCT01372410|147560878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.045|0.158|||Mixed Models Analysis|||||0.158|0.045|<0.001
74005702|NCT01372410|147560878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.068|0.179|||Mixed Models Analysis|||||0.179|0.068|<0.001
74005703|NCT01372410|147560878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|||<|0.001|TWO_SIDED|95.0|0.127|0.239|||Mixed Models Analysis|||||0.239|0.127|<0.001
74005704|NCT01372410|147560878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|||<|0.001|TWO_SIDED|95.0|0.069|0.182|||Mixed Models Analysis|||||0.182|0.069|<0.001
74005705|NCT01372410|147560878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|||<|0.001|TWO_SIDED|95.0|0.083|0.196|||Mixed Models Analysis|||||0.196|0.083|<0.001
74005706|NCT01372410|147560878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.045|0.157|||Mixed Models Analysis|||||0.157|0.045|<0.001
74005707|NCT01067326|147560927|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||Change in EPCs from baseline to 4 months||||0.02
74005708|NCT01067326|147560928|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||t-test, 2 sided|||Difference in systolic blood pressure from baseline to 4 months.||||.006
74005709|NCT01067326|147560929|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Difference in diastolic blood pressure from baseline to 4 months.||||0.04
74005710|NCT01067326|147560930|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||P-value for intergroup comparison of change from baseline to month 4||||0.94
74005711|NCT00696761|147560931|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
74005712|NCT00696761|147560932|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Kruskal-Wallis|||The Kruskal-Wallis test, analysis of variance, and the Wilcoxon signed rank-sum test were used to compare changes from baseline to endpoint after treatment.||||<0.05
74005713|NCT02411578|147560959|SUPERIORITY|||||||0.99||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||For the crossover trial primary analysis, analyzed events were study treatment events meeting the following criteria: a) a survey was completed in the smart phone application, b) the initial BG measurement was 40 to 69 mg/dL, c) BG measurements were performed at both the 15-minute (in a window of 13 to 20 minutes) and 30-minute (28 to 40 minutes) time points, and d) appropriate treatment including dose was taken both at the initial and 15-minute time points.||||0.99
74005714|NCT02411578|147560960|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.34
74005715|NCT02411578|147560961|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.01
74005716|NCT02411578|147560962|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.02
74005717|NCT02411578|147560963|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.86
74005718|NCT02411578|147560964|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.95
74005719|NCT02411578|147560965|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.78
74005720|NCT02411578|147560966|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.21
74005721|NCT02411578|147560967|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.09
74005722|NCT02411578|147560968|SUPERIORITY|||||||0.49|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.49
74005723|NCT02411578|147560969|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.63
74005724|NCT02411578|147560970|SUPERIORITY|||||||0.41|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.41
74005725|NCT02411578|147560971|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.80
74005726|NCT02411578|147560972|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.13
74005727|NCT02411578|147560973|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.70
74005728|NCT02411578|147560974|SUPERIORITY|||||||0.93||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.93
74005729|NCT02411578|147560975|SUPERIORITY|||||||0.66||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.66
74005730|NCT02411578|147560976|SUPERIORITY|||||||0.08||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.08
74005731|NCT01557348|147560979|SUPERIORITY_OR_OTHER|||||||0.0068||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||||||0.0068
74005732|NCT01557348|147560980|SUPERIORITY_OR_OTHER|||||||0.0588||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||||||0.0588
74005733|NCT01557348|147560981|SUPERIORITY_OR_OTHER|||||||0.1126||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 6||||0.1126
74005734|NCT01557348|147560981|SUPERIORITY_OR_OTHER|||||||0.2342||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 12||||0.2342
74005735|NCT01557348|147560982|SUPERIORITY_OR_OTHER|||||||0.4168||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 6||||0.4168
74005736|NCT01557348|147560982|SUPERIORITY_OR_OTHER|||||||0.5867||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 12||||0.5867
74005737|NCT01557348|147560983|SUPERIORITY_OR_OTHER|||||||0.8758||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 6||||0.8758
74005738|NCT01557348|147560983|SUPERIORITY_OR_OTHER|||||||0.4849||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 12||||0.4849
74038445|NCT01231607|147630373|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|33.0||||0.002||99.165|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.|||60|6.1|0.002
74005739|NCT01557348|147560984|SUPERIORITY_OR_OTHER|||||||0.0086||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 6||||0.0086
74005740|NCT01557348|147560984|SUPERIORITY_OR_OTHER|||||||0.2918||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 12||||0.2918
74005741|NCT01557348|147560985|SUPERIORITY_OR_OTHER|||||||0.0764||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 6||||0.0764
74005742|NCT01557348|147560985|SUPERIORITY_OR_OTHER|||||||0.0587||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 12||||0.0587
74005743|NCT01557348|147560986|SUPERIORITY_OR_OTHER|||||||0.0443||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 6||||0.0443
74005744|NCT01557348|147560986|SUPERIORITY_OR_OTHER|||||||0.4802||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 12||||0.4802
74005745|NCT01557348|147560987|SUPERIORITY_OR_OTHER|||||||0.2026||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 6||||0.2026
74005746|NCT01557348|147560987|SUPERIORITY_OR_OTHER|||||||0.0295||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 12||||0.0295
74005747|NCT01557348|147560988|SUPERIORITY_OR_OTHER|||||||0.337||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 6||||0.3370
74005748|NCT01557348|147560988|SUPERIORITY_OR_OTHER|||||||0.1515||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 12||||0.1515
74005749|NCT01557348|147560989|SUPERIORITY_OR_OTHER|||||||0.3253||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 6||||0.3253
74005750|NCT01557348|147560989|SUPERIORITY_OR_OTHER|||||||0.3535||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 12||||0.3535
74005751|NCT02708095|147561018|SUPERIORITY||Odds Ratio (OR)|1.28||||0.392|TWO_SIDED|95.0|0.73|2.27|||Regression, Logistic|||||2.27|0.73|0.392
74005752|NCT02708095|147561018|SUPERIORITY||Odds Ratio (OR)|1.84||||0.041|TWO_SIDED|95.0|1.02|3.29|||Regression, Logistic|||||3.29|1.02|0.041
74005753|NCT02708095|147561019|SUPERIORITY||Odds Ratio, log|1.25||||0.44|TWO_SIDED|95.0|0.71|2.19|||Regression, Logistic|||||2.19|0.71|0.440
74005754|NCT02708095|147561019|SUPERIORITY||Odds Ratio (OR)|2.04||||0.015|TWO_SIDED|95.0|1.15|3.62|||Regression, Logistic|||||3.62|1.15|0.015
74005755|NCT02708095|147561020|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.26||||0.6|TWO_SIDED|95.0|-1.23|0.71|||Mixed Models Analysis|||||0.71|-1.23|0.600
74005756|NCT02708095|147561020|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.58||||0.243|TWO_SIDED|95.0|-1.55|0.39|||Mixed Models Analysis|||||0.39|-1.55|0.243
74005757|NCT02708095|147561021|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.16||||0.285|TWO_SIDED|95.0|-0.45|0.13|||Mixed Models Analysis|||||0.13|-0.45|0.285
74005758|NCT02708095|147561021|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.33||||0.026|TWO_SIDED|95.0|-0.62|-0.04|||Mixed Models Analysis|||||-0.04|-0.62|0.026
74005759|NCT02083705|147561031|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||"We hypothesised that during neonatal CPR, CC+SI will reduce the time needed to achieve ROSC. Our aim was to examine if CC+SI reduces ROSC compared with 3:1 C:V CPR in preterm infants \<33 weeks of gestation.~For this pilot study, based on the local incidence of CPR in preterm neonates, a convenient sample size of five patients per group was enrolled. Our primary outcome was time to achieve ROSC measured using ECG."||||0.05
74005760|NCT03891524|147561060|OTHER|||||||0.0004|||||||MCP-mod analysis|||||||0.0004
74005761|NCT03891524|147561061|OTHER|||||||0.7188|||||||MCP-MOD analysis|||||||0.7188
74005762|NCT02684357|147561079|OTHER||Adjusted percentage difference|72.5|||<|0.001|TWO_SIDED|95.0|66.8|78.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||78.2|66.8|< 0.001
74005763|NCT02684357|147561080|OTHER||Adjusted percentage difference|78.5|||<|0.001|TWO_SIDED|95.0|72.4|84.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||84.5|72.4|< 0.001
74005764|NCT02684357|147561081|OTHER||Adjusted percentage difference|47.5|||<|0.001|TWO_SIDED|95.0|40.9|54.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||54.2|40.9|< 0.001
74005765|NCT02684357|147561082|OTHER||Adjusted percentage difference|48.2|||<|0.001|TWO_SIDED|95.0|41.9|54.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||54.6|41.9|< 0.001
74005766|NCT02684357|147561083|OTHER||Adjusted percentage difference|62.2|||<|0.001|TWO_SIDED|95.0|55.5|68.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||68.9|55.5|< 0.001
74005767|NCT02684357|147561084|OTHER||Adjusted percentage difference|31.2|||<|0.001|TWO_SIDED|95.0|25.7|36.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||36.6|25.7|< 0.001
74005768|NCT02684357|147561085|OTHER||Adjusted percentage difference|27.6|||<|0.001|TWO_SIDED|95.0|16.7|38.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||38.5|16.7|< 0.001
74005769|NCT02684357|147561086|OTHER||Adjusted percentage difference|22.3|||<|0.001|TWO_SIDED|95.0|12.0|32.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.5|12.0|< 0.001
74005770|NCT02684357|147561087|OTHER||Adjusted percentage difference|27.0|||<|0.001|TWO_SIDED|95.0|17.0|37.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||37.0|17.0|< 0.001
74005771|NCT02684357|147561088|OTHER||Adjusted percentage difference|26.3|||<|0.001|TWO_SIDED|95.0|16.1|36.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||36.4|16.1|< 0.001
74005772|NCT02684357|147561089|OTHER||Adjusted percentage difference|30.2|||<|0.001|TWO_SIDED|95.0|19.6|40.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.9|19.6|< 0.001
74005773|NCT02684357|147561090|OTHER||Adjusted percentage difference|29.5|||<|0.001|TWO_SIDED|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.1|18.9|< 0.001
74005774|NCT02684357|147561091|OTHER||Adjusted percentage difference|29.5|||<|0.001|TWO_SIDED|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.1|18.9|< 0.001
74005775|NCT02684357|147561092|OTHER||Adjusted percentage difference|19.2|||<|0.001|TWO_SIDED|95.0|9.5|28.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||28.8|9.5|< 0.001
74005776|NCT02684357|147561093|OTHER||Adjusted percentage difference|18.0|||<|0.001|TWO_SIDED|95.0|7.8|28.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||28.3|7.8|< 0.001
74005777|NCT02684357|147561094|OTHER||Adjusted percentage difference|20.2|||<|0.001|TWO_SIDED|95.0|9.1|31.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||31.4|9.1|< 0.001
74005778|NCT02684357|147561095|OTHER||Mean Difference (Final Values)|-6.375|||<|0.001|TWO_SIDED|95.0|-7.102|-5.648|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||-5.648|-7.102|< 0.001
74005779|NCT02684357|147561096|OTHER||Adjusted percentage difference|84.7|||<|0.001|TWO_SIDED|95.0|79.0|90.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||90.4|79.0|< 0.001
74005780|NCT02684357|147561097|OTHER||Adjusted percentage difference|29.1|||<|0.001|TWO_SIDED|95.0|18.5|39.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||39.6|18.5|< 0.001
74005781|NCT02684357|147561098|OTHER||Adjusted percentage difference|14.7||||0.001|TWO_SIDED|95.0|5.9|23.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||23.5|5.9|0.001
74005782|NCT01839487|147561101|OTHER||Hazard Ratio (HR)|0.74||||0.058|TWO_SIDED|95.0|0.54|1.01||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG was based on Cox proportional hazards model stratified by the Karnofsky Performance Status (KPS) category (70-80% and 90-100%) at screening using AG as the reference arm.||1.01|0.54|0.058
74005783|NCT01839487|147561103|OTHER||Hazard Ratio (HR)|0.57||||0.092|TWO_SIDED|95.0|0.3|1.1||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG for HA-high was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.10|0.30|0.092
74005784|NCT01839487|147561103|OTHER||Hazard Ratio (HR)|0.88||||0.514|TWO_SIDED|95.0|0.59|1.31||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG for HA-low was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.31|0.59|0.514
74005785|NCT01839487|147561104|OTHER||Risk Ratio (RR)|1.22||||0.225|TWO_SIDED|95.0|0.88|1.68||Threshold for significance at 0.1 level.|Cochran-Mantel-Haenszel|||p-Value and relative risk were based on a stratified Cochran-Mantel-Haenszel method using KPS category at screening as the stratification factor.||1.68|0.88|0.225
74005786|NCT01839487|147561105|OTHER||Hazard Ratio (HR)|0.91||||0.495|TWO_SIDED|95.0|0.7|1.19||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.19|0.70|0.495
74005787|NCT03471871|147561110|OTHER||Least squares (LS) mean difference|-0.36||||0.099|TWO_SIDED|95.0|-0.78|0.07||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||0.07|-0.78|0.099
74005788|NCT03471871|147561110|OTHER||LS mean difference|-0.29||||0.176|TWO_SIDED|95.0|-0.72|0.14||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||0.14|-0.72|0.176
74005789|NCT03471871|147561111|OTHER||LS mean difference|-0.06||||0.948|TWO_SIDED|95.0|-1.95|1.83||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||1.83|-1.95|0.948
74005790|NCT03471871|147561112|OTHER||LS mean difference|0.52||||0.639|TWO_SIDED|95.0|-1.72|2.76||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||2.76|-1.72|0.639
74005791|NCT03471871|147561112|OTHER||LS mean difference|-1.16||||0.297|TWO_SIDED|95.0|-3.4|1.08||P-Value was at the 0.05 level of significance.|mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||1.08|-3.40|0.297
74005792|NCT03471871|147561113|OTHER||LS mean difference|-0.03||||0.979|TWO_SIDED|95.0|-2.22|2.17||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||2.17|-2.22|0.979
74005793|NCT03471871|147561114|OTHER||LS mean difference|0.185||||0.095|TWO_SIDED|95.0|-0.034|0.405||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<90%||0.405|-0.034|0.095
74038446|NCT01231607|147630373|SUPERIORITY_OR_OTHER||Least squares mean difference|-39.4|||<|0.001|TWO_SIDED|98.33|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.|||-12.7|-66.1|<0.001
74005794|NCT03471871|147561114|OTHER||LS mean difference|0.245||||0.03|TWO_SIDED|95.0|0.025|0.464||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||When SpO2 is \<90%||0.464|0.025|0.030
74005795|NCT03471871|147561114|OTHER||LS mean difference|0.004||||0.885|TWO_SIDED|95.0|-0.058|0.067||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<85%||0.067|-0.058|0.885
74005796|NCT03471871|147561114|OTHER||LS mean difference|0.044||||0.158|TWO_SIDED|95.0|-0.018|0.107||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<85%||0.107|-0.018|0.158
74005797|NCT03471871|147561114|OTHER||LS mean difference|0.001||||0.462|TWO_SIDED|95.0|-0.002|0.005||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<80%||0.005|-0.002|0.462
74005798|NCT03471871|147561114|OTHER||LS mean difference|0.002||||0.166|TWO_SIDED|95.0|-0.001|0.006||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<80%||0.006|-0.001|0.166
74005799|NCT03471871|147561116|OTHER||LS mean difference|0.07||||0.699|TWO_SIDED|95.0|-0.31|0.46||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: Mean SpO2 during TST||0.46|-0.31|0.699
74005800|NCT03471871|147561116|OTHER||LS mean difference|0.25||||0.169|TWO_SIDED|95.0|-0.11|0.61||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: Mean SpO2 during TST||0.61|-0.11|0.169
74005801|NCT03471871|147561117|OTHER||LS mean difference|0.312||||0.472|TWO_SIDED|95.0|-0.558|1.181||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<90%||1.181|-0.558|0.472
74005802|NCT03471871|147561117|OTHER||LS mean difference|0.067||||0.479|TWO_SIDED|95.0|-0.124|0.258||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<85%||0.258|-0.124|0.479
74005803|NCT03471871|147561117|OTHER||LS mean difference|0.002||||0.852|TWO_SIDED|95.0|-0.019|0.023||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<80%||0.023|-0.019|0.852
74005804|NCT03471871|147561117|OTHER||LS mean difference|0.088||||0.733|TWO_SIDED|95.0|-0.431|0.607||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is \<90%||0.607|-0.431|0.733
74005805|NCT03471871|147561117|OTHER||LSM difference|0.056||||0.518|TWO_SIDED|95.0|-0.117|0.228||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: When SpO2 is \<85%||0.228|-0.117|0.518
74005806|NCT03471871|147561117|OTHER||LS mean difference|0.006||||0.576|TWO_SIDED|95.0|-0.015|0.026||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is \<80%||0.026|-0.015|0.576
74038447|NCT01231607|147630373|SUPERIORITY_OR_OTHER||Least squares mean difference|6.5||||0.56|TWO_SIDED|98.33|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.|||33.1|-20.1|0.56
74038448|NCT01231607|147630373|SUPERIORITY_OR_OTHER||Least squares mean difference|33.0||||0.003|TWO_SIDED|98.33|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.|||60|6.1|0.003
74038449|NCT02307838|147630393|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.59||||0.0155|TWO_SIDED|95.0|-1.07|-0.11|||ANCOVA|||||-0.11|-1.07|0.0155
74005807|NCT03971422|147561119|SUPERIORITY||LS Mean Difference|-2.586|||<|0.001|TWO_SIDED|95.0|-4.091|-1.249||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||Mixed model repeated measure (MMRM) ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.249|-4.091|<0.001
74005808|NCT03971422|147561119|SUPERIORITY||LS Mean Difference|-2.619|||<|0.001|TWO_SIDED|95.0|-3.994|-1.163||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM analysis of covariance (ANCOVA) model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.163|-3.994|<0.001
74038450|NCT03372603|147630417|OTHER||Ratio|1.336|||||TWO_SIDED|90.0|0.965|1.847|||||Treatment comparison ratio of GSK2798745 and placebo using posterior median ratio and 90% credible interval is presented.|||1.847|0.965|
74038451|NCT01632735|147630449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||<|0.05|TWO_SIDED|95.0|0.57|0.99|||GEE|Generalized Estimating Equations regression examined primary relapse (measured by urinalysis) over time by condition, controlling for age and gender.||||0.99|0.57|<0.05
74005809|NCT03971422|147561120|SUPERIORITY||Odds Ratio (OR)|5.765|||<|0.001|TWO_SIDED|95.0|2.1|14.882||p-value is nominal. Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Wald test||The OR of responder rates is estimated and tested between treatment groups using logistic regression model with treatment group, Baseline MG-ADL score and stratification factor (MuSK+ or AChR+). An OR \> 1 favours rozanolixizumab.|||14.882|2.100|<0.001
74005810|NCT03971422|147561120|SUPERIORITY||Odds Ratio (OR)|4.273|||<|0.001|TWO_SIDED|95.0|1.653|11.791||p-value is nominal. Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Wald test||The OR of responder rates is estimated and tested between treatment groups using logistic regression model with treatment group, Baseline MG-ADL score and stratification factor (MuSK+ or AChR+). An OR \> 1 favours rozanolixizumab.|||11.791|1.653|<0.001
74005811|NCT03971422|147561121|SUPERIORITY||LS Mean Difference|-3.901|||<|0.001|TWO_SIDED|95.0|-6.634|-1.245||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.245|-6.634|<0.001
74005812|NCT03971422|147561121|SUPERIORITY||LS Mean Difference|-5.525|||<|0.001|TWO_SIDED|95.0|-8.303|-2.968||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-2.968|-8.303|<0.001
74005813|NCT03971422|147561122|SUPERIORITY||LS Mean Difference|-3.483|||<|0.001|TWO_SIDED|95.0|-5.614|-1.584||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.584|-5.614|<0.001
74005814|NCT03971422|147561122|SUPERIORITY||LS Mean Difference|-4.756|||<|0.001|TWO_SIDED|95.0|-6.821|-2.859||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-2.859|-6.821|<0.001
74005815|NCT03971422|147561123|SUPERIORITY||LS Mean Difference|-12.441|||<|0.001|TWO_SIDED|95.0|-21.804|-4.089||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-4.089|-21.804|<0.001
74005816|NCT03971422|147561123|SUPERIORITY||LS Mean Difference|-15.163|||<|0.001|TWO_SIDED|95.0|-23.596|-6.45||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-6.450|-23.596|<0.001
74005817|NCT03971422|147561124|SUPERIORITY||LS Mean Difference|-8.65||||0.012|TWO_SIDED|95.0|-18.058|-0.134||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-0.134|-18.058|0.012
74005818|NCT03971422|147561124|SUPERIORITY||LS Mean Difference|-14.822|||<|0.001|TWO_SIDED|95.0|-23.759|-5.936||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-5.936|-23.759|<0.001
74005819|NCT03971422|147561125|SUPERIORITY||LS Mean Difference|-11.32|||<|0.001|TWO_SIDED|95.0|-18.958|-4.998||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-4.998|-18.958|<0.001
74005820|NCT03971422|147561125|SUPERIORITY||LS Mean Difference|-10.705|||<|0.001|TWO_SIDED|95.0|-17.787|-3.998||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-3.998|-17.787|<0.001
74005821|NCT03566810|147561145|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric Least Square(LS)Mean%|98.69|||||TWO_SIDED|90.0|92.2|105.64||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||105.64|92.20|
74005822|NCT03566810|147561145|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|99.39|||||TWO_SIDED|90.0|93.15|106.05||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||106.05|93.15|
74005823|NCT03566810|147561146|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.92|||||TWO_SIDED|90.0|91.08|107.44||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||107.44|91.08|
74005824|NCT03566810|147561146|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|96.89|||||TWO_SIDED|90.0|89.87|104.46||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||104.46|89.87|
74005825|NCT03566810|147561147|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||TWO_SIDED|90.0|-0.5|0.0||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||0.00|-0.50|
74005826|NCT03566810|147561147|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||TWO_SIDED|90.0|-0.5|0.5||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||0.50|-0.50|
74005827|NCT03566810|147561149|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|97.89|||||TWO_SIDED|90.0|91.38|104.86||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||104.86|91.38|
74005828|NCT03566810|147561149|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.08|||||TWO_SIDED|90.0|92.37|104.14||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||104.14|92.37|
74005829|NCT00826111|147561185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0085|STANDARD_ERROR_OF_MEAN|0.0534||0.88|TWO_SIDED|95.0|-0.139|0.0122|||t-test, 2 sided|||||.01220|-0.1390|0.88
74005830|NCT00826111|147561186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.112||0.79|TWO_SIDED|95.0|-0.286|0.224|||t-test, 2 sided|||||0.224|-0.286|0.79
74005831|NCT00826111|147561187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0222|STANDARD_ERROR_OF_MEAN|0.0128||0.16|TWO_SIDED|95.0|-0.58|0.0136|||t-test, 2 sided|||||.0136|-0.580|0.16
74005832|NCT00826111|147561188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.515||0.29|TWO_SIDED|95.0|-1.35|2.77|||t-test, 2 sided|||||2.77|-1.35|0.29
74091037|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-17.19|STANDARD_ERROR_OF_MEAN|27.0135|||TWO_SIDED|95.0|-70.9|36.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||36.5|-70.9|
74005833|NCT00826111|147561189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0048|STANDARD_ERROR_OF_MEAN|0.005||0.37|TWO_SIDED|95.0|-0.0077|0.0174|||t-test, 2 sided|||||0.0174|-0.0077|0.37
74005834|NCT00826111|147561190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0056|STANDARD_ERROR_OF_MEAN|0.0042||0.21|TWO_SIDED|95.0|-0.0037|0.1481|||t-test, 2 sided|||||0.1481|-0.0037|0.21
74005835|NCT00826111|147561191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.35|STANDARD_ERROR_OF_MEAN|3.94||0.1|TWO_SIDED|95.0|-1.76|16.46|||t-test, 2 sided|||||16.46|-1.76|0.10
74005836|NCT00826111|147561192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|4.06||0.89|TWO_SIDED|95.0|-9.31|10.51|||t-test, 2 sided|||||10.51|-9.31|0.89
74005837|NCT00826111|147561193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|3.78||0.66|TWO_SIDED|95.0|-10.31|6.91|||t-test, 2 sided|||||6.91|-10.31|0.66
74005838|NCT01672788|147561194|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.31|STANDARD_DEVIATION|10.7|||TWO_SIDED|90.0|96.89|105.93|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.93|96.89|
74005839|NCT01672788|147561194|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.3|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|97.4|103.29|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||103.29|97.40|
74005840|NCT01672788|147561195|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose.|Geometric Mean Ratio|101.61|STANDARD_DEVIATION|8.8|||TWO_SIDED|90.0|97.94|105.41|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||105.41|97.94|
74005841|NCT01672788|147561195|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|98.56|STANDARD_DEVIATION|10.8|||TWO_SIDED|90.0|94.24|103.08|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||103.08|94.24|
74005842|NCT01672788|147561196|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.2|STANDARD_DEVIATION|10.4|||TWO_SIDED|90.0|96.89|105.71|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.71|96.89|
74005843|NCT01672788|147561196|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.31|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|97.41|103.3|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||103.30|97.41|
74005844|NCT01672788|147561197|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|102.7|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|98.75|106.81|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||106.81|98.75|
74005845|NCT01672788|147561197|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.97|STANDARD_DEVIATION|12.3|||TWO_SIDED|90.0|95.94|106.27|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||106.27|95.94|
74005846|NCT01672788|147561198|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|99.64|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|95.39|104.09|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||104.09|95.39|
74005847|NCT01672788|147561198|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|97.89|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|93.82|102.15|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||102.15|93.82|
74005848|NCT01672788|147561199|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|101.51|STANDARD_DEVIATION|8.6|||TWO_SIDED|90.0|97.95|105.21|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.21|97.95|
74005849|NCT01672788|147561199|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose .|Geometric Mean Ratio|98.57|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|94.5|102.81|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||102.81|94.50|
74005850|NCT04697264|147561223|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.026||||||Adjustments to the p-values for multiple comparison were performed using Benjamini and Hochberg approach on 'R' and represented in the text as adjusted p-value.|Regression, Linear|||The influence of age on adiponectin levels was analysed by dividing the population into binary groups (\<60 years and \>/= 60 years) to facilitate comparison.||||0.026
74005851|NCT04697264|147561223|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.496||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on adiponectin levels was analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||0.496
74005852|NCT04697264|147561223|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05|||||||Regression, Linear|||The influence of age on leptin levels was analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
74005853|NCT04697264|147561223|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on IGF1 and 2 levels were analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
74005854|NCT04697264|147561223|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on IGF1 and 2 levels were analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
74005855|NCT04697264|147561223|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of adiponectin, leptin, IGF1 and 2 were analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||>0.05
74038452|NCT01632735|147630450|SUPERIORITY_OR_OTHER||Beta (timexcondition)|0.239|||<|0.001|TWO_SIDED|95.0|0.219|0.248|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the primary outcome measures of recovery behaviors mean days over time (baseline, discharge, 3, 6, and 9-month follow-ups).||0.248|0.219|<0.001
74005856|NCT04697264|147561223|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.014||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of adiponectin was analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.014
74005857|NCT04697264|147561223|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.006||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of leptin was analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.006
74005858|NCT04697264|147561223|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.019||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of IGF1 and IGF2 were analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.019
74005859|NCT04697264|147561224|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.033||||||Adjustments to the p-values for multiple comparison were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of LVSI on adiponectin levels were assessed using multivariate linear regression, with binary categorisations (presence and absence of LVSI) to facilitate comparisons.||||0.033
74005860|NCT04697264|147561224|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.015||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of MELF on TNF levels were assessed using multivariate linear regression, with binary categorisations (presence and absence of MELF) to facilitate comparisons.||||0.015
74005861|NCT04697264|147561224|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of tumour grade (Grade 1/2), stage (Stage 1/ \>/=1), histology (type 1 and type 2), and MSI (presence or absence) on the biomarker levels (adiponectin, leptin, IGF 1 and 2, IL6 and TNF) were assessed using multivariate linear regression, with binary categorisations to facilitate comparisons.||||>0.05
74005862|NCT04697264|147561225|OTHER||||||<|0.0001||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||<0.0001
74005863|NCT04697264|147561226|OTHER||||||>|0.05||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||>0.05
74091038|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-39.62|STANDARD_ERROR_OF_MEAN|29.3023|||TWO_SIDED|95.0|-97.7|18.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||18.5|-97.7|
74091039|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-37.06|STANDARD_ERROR_OF_MEAN|29.5797|||TWO_SIDED|95.0|-95.7|21.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||21.6|-95.7|
74091040|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-52.45|STANDARD_ERROR_OF_MEAN|24.8429|||TWO_SIDED|95.0|-101.8|-3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-3.1|-101.8|
74005864|NCT04697264|147561227|OTHER||||||<|0.05||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||<0.05
74005865|NCT04697264|147561228|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between adiponectin and the BMI of the study population at baseline."||||>0.05
74005866|NCT04697264|147561228|OTHER|||||||0.09||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between leptin and the BMI of the study population at baseline."||||0.09
74005867|NCT04697264|147561228|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the association between IL6, TNFα, IGF1, and IGF2 and the BMI of the study population at baseline."||||>0.05
74005868|NCT04697264|147561229|OTHER|||||||0.004||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between adiponectin and the BMI of the control population at baseline."||||0.004
74005869|NCT04697264|147561229|OTHER|||||||0.0002||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between leptin and the BMI of the control population at baseline."||||0.0002
74005870|NCT04697264|147561229|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between IL6, TNFα, IGF1, and IGF2 and the BMI of the control population at baseline."||||>0.05
74005871|NCT04697264|147561230|OTHER|||||||0.0007||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||||||0.0007
74005872|NCT04697264|147561231|OTHER||||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||Leptin levels were compared between the day 0 and 6 months post-operative bloods.||||>0.05
74005873|NCT04697264|147561231|OTHER|||||||0.004||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||IGF1 levels were compared between the day 0 and 6 months post-operative bloods.||||0.004
74005874|NCT04697264|147561231|OTHER||||||<|0.0001||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||IGF2 levels were compared between the day 0 and 6 months post-operative bloods.||||<0.0001
74005875|NCT04697264|147561233|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Expression of adiponectin was studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||<0.0001
74005876|NCT04697264|147561233|OTHER||||||<|0.05|||||||t-test, 2 sided|||Expression of leptin and their receptors were studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||<0.05
74005877|NCT04697264|147561233|OTHER||||||>|0.05|||||||t-test, 2 sided|||Expression of adiponectin receptors were studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||>0.05
74005878|NCT04697264|147561234|OTHER|||||||0.0002|||||||t-test, 2 sided|||Expression of adiponectin was studied in endometrial cancer tissue and lymph node tissue using qRT-PCR.||||0.0002
74005879|NCT04697264|147561234|OTHER|||||||0.011|||||||t-test, 2 sided|||Expression of leptin was studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||0.011
74005880|NCT04697264|147561234|OTHER|||||||0.009|||||||t-test, 2 sided|||The expression of IL6 receptor (IL6R) was studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||0.009
74005881|NCT04697264|147561234|OTHER||||||>|0.05|||||||t-test, 2 sided|||The expression of adiponectin receptor, leptin receptor, IGF1 and IGF 2 receptors, IL6, TNF, IGF1 and IGF2 were studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||>0.05
74039860|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.15||0.0121|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.69|0.0121
74005882|NCT04697264|147561235|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating adiponectin levels and the expression of these markers and their receptors in endometrial tissue were compared using correlation studies.||||>0.05
74005883|NCT04697264|147561236|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating leptin, IGF1 and IGF2 levels and the expression of these markers and their receptors in endometrial tissue were compared using Pearson's correlation studies.||||>0.05
74005884|NCT04697264|147561237|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating IL6 and TNF levels and the expression of these markers and their receptors in endometrial tissue were compared using Pearson's correlation studies.||||>0.05
73878331|NCT03489863|147295952|NON_INFERIORITY|see above|Mean Difference (Net)|-18.0|||<|0.05|TWO_SIDED|95.0|-38.0|2.0|||ANCOVA|||The primary endpoint is non-inferiority in PRU, at 24 hours of prasugrel versus ticagrelor. Under the assumption of 0 difference at 24 hours in mean PRU between ticagrelor and prasugrel and a common standard deviation of 50 PRU, a sample size of 22 patients per group allows for the 95% CI to stay within ± 45 PRU with a 90% power and alpha = 0.05.||2|-38|<0.05
73878332|NCT01173016|147295975|OTHER|||||||0.038|||||||Regression, Logistic|||Impact of anti-laronidase antibody status on the change in 6MWT outcome was tested||||0.038
73878333|NCT00657540|147295976|SUPERIORITY_OR_OTHER|||||||0.0185|||||||Chi-squared|The proportion of treatment failures was compared between groups using a one-sided test at the 0.025 level of significance.||||||0.0185
73957239|NCT04771273|147450412|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-43.64|||<|0.0001|TWO_SIDED|95.0|-53.49|-33.79||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-33.79|-53.49|<.0001
74005885|NCT01324323|147561276|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean (%)|179.3|||||TWO_SIDED|90.0|160.3|200.7|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||200.7|160.3|
74005886|NCT01324323|147561277|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|178.3|||||TWO_SIDED|90.0|159.4|199.4|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||199.4|159.4|
74005887|NCT01324323|147561278|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|179.6|||||TWO_SIDED|90.0|160.5|201.0|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||201.0|160.5|
74005888|NCT01324323|147561279|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|159.1|||||TWO_SIDED|90.0|135.8|186.5|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||186.5|135.8|
74005889|NCT01324323|147561280|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.15||||0.791|TWO_SIDED|90.0|-1.0|1.01|||Wilcoxon signed-rank|||"Note: The median, median difference (romidepsin + rifampin minus romidepsin) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test."||1.01|-1.0|0.7910
74005890|NCT03153137|147561285|SUPERIORITY|For each stage, the p-value from the ANCOVA model including randomized treatment, geographical region, and baseline peak VO2 was used to construct the final adjusted p-value.|Median unbiased estimate and repeated CI|0.62|||=|0.193|TWO_SIDED|99.0|-0.62|1.85||Final adjusted p-value (from weighted inverse normal combination test)|ANCOVA|||Due to adaptive nature of the design, the main analysis was conducted on FAS using the inverse normal combination method with pre-specified weights to combine first and second stage p-values.||1.85|-0.62|= 0.1930
74005891|NCT01821378|147561312|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.1||||0.255|TWO_SIDED|95.0|-8.4|2.2|||Mixed Models Analysis|||||2.2|-8.4|0.255
74038453|NCT01632735|147630451|SUPERIORITY_OR_OTHER||Beta (time x condition)|0.115|||<|0.001|TWO_SIDED|95.0|0.106|0.123|||Mixed Models Analysis|A repeated-measures model tested for effects of treatment vs. control on recovery self-confidence over time controlling for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of recovery confidence mean score over time.||0.123|0.106|<0.001
74038454|NCT01632735|147630452|SUPERIORITY_OR_OTHER||Beta effect (timexcondition)|0.217|||<|0.001|TWO_SIDED|95.0|0.2|0.233|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of self-help utilization (mean days in past month) over the study period (baseline, discharge, and 3-, 6-, and 9-month follow-ups).||0.233|0.2|<0.001
73878334|NCT00657540|147295977|SUPERIORITY_OR_OTHER|||||||0.2302|||||||Chi-squared|Chi-squared tests at the 0.025 level of significance were used to test for a difference in proportions between the treatment groups.||||||0.2302
73878335|NCT00657540|147295978|SUPERIORITY_OR_OTHER|||||||0.8213|||||||Chi-squared|The proportion of subjects with at least one drug-related adverse event by treatment groups using a two-sided test at the 0.05 level of significance.||||||0.8213
73878336|NCT00657540|147295979|SUPERIORITY_OR_OTHER|||||||0.2765|||||||Chi-squared|The proportion of subjects with decreased pain at any time point between treatment groups using a one-sided test at the 0.025 level of significance.||||||0.2765
73878337|NCT02656017|147295990|SUPERIORITY||Mean Difference (Net)|0.07||||0.5|TWO_SIDED|95.0|-0.13|0.26|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in GSRS score as a function of time, the interaction between time and study arm, and clinical site.||0.26|-0.13|0.50
73878338|NCT02656017|147295991|SUPERIORITY|||||||0.12|||||||Gray's test|||The Gray's test of homogeneity for competing risks was used to compare cumulative incidence of tolerating the drug between study arms.||||0.12
73878339|NCT02656017|147295992|SUPERIORITY|||||||0.98|||||||Regression, Logistic|||Cumulative incidence between study arms and logistic regression was used to assess the association between study arms.||||0.98
73878340|NCT02656017|147295993|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.72|TWO_SIDED|95.0|-1.81|2.6|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in SF-36 PCS as a function of time, the interaction between time and study arm, and clinical site.||2.60|-1.81|0.72
74005892|NCT01821378|147561312|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-10.3|||<|-0.001|TWO_SIDED|95.0|-14.9|-5.7|||Mixed Models Analysis|||||-5.7|-14.9|<-0.001
74038455|NCT02475395|147630457|OTHER||Sensitivity|90.0|||||TWO_SIDED|95.0|79.9|95.3|||||Sensitivity estimates the percent true positive results obtained by Trak. Positive results are less than 15 M/mL sperm concentration and are part of a sub fertile diagnostic assessment.|||95.3|79.9|
74038456|NCT02475395|147630457|OTHER||Specificity|93.3|||||TWO_SIDED|95.0|88.7|96.1|||||Specificity is calculated by the percentage of true negative results obtained using Trak compared to reference method. Negative (for subfertility) results are greater than 15 M/mL.|||96.1|88.7|
74038457|NCT02475395|147630458|OTHER||Sensitivity|95.0|||||TWO_SIDED|95.0|86.3|98.3||||||||98.3|86.3|
74038458|NCT02475395|147630458|OTHER||Specificity|94.9|||||TWO_SIDED|95.0|90.6|97.3||||||||97.3|90.6|
74038459|NCT02475395|147630459|OTHER||Sensitivity|96.7|||||TWO_SIDED|95.0|88.7|99.1||||||||99.1|88.7|
74038460|NCT02475395|147630459|OTHER||Specificity|93.8|||||TWO_SIDED|95.0|89.2|96.5||||||||96.5|89.2|
74038461|NCT00115765|147630466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.011||95.0|1.06|1.52|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose \< 85 mg/m2, and oxaliplatin dose \> 100 mg/m2||||1.52|1.06|0.011
74038462|NCT00115765|147630467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.005||95.0|1.11|1.83|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose \< 85 mg/m2, and oxaliplatin dose \> 100 mg/m2||||1.83|1.11|0.005
74038463|NCT00115765|147630471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.738||95.0|0.6|2.05|||Regression, Logistic|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site||||2.05|0.60|0.738
74038464|NCT00115765|147630472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.42||||0.257||95.0|0.77|2.62|||Regression, Cox|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site||||2.62|0.77|0.257
74038465|NCT00115765|147630474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||||95.0|1.04|1.77||||||||1.77|1.04|
74038466|NCT00115765|147630475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||||95.0|0.91|1.71||||||||1.71|0.91|
74038467|NCT00115765|147630476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.89||||||95.0|1.3|2.75||||||||2.75|1.30|
74038468|NCT00115765|147630477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||||95.0|0.67|1.54||||||||1.54|0.67|
74038469|NCT00115765|147630478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||||95.0|0.61|2.66||||||||2.66|0.61|
74038470|NCT00115765|147630479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||||95.0|0.28|1.67||||||||1.67|0.28|
74038471|NCT03011450|147630510|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038472|NCT03011450|147630511|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038473|NCT03011450|147630512|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038474|NCT03011450|147630513|SUPERIORITY|||||||0.0156|||||||Hodges-Lehmann method|||||||0.0156
74038475|NCT03011450|147630514|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038476|NCT03011450|147630515|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038477|NCT03011450|147630516|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038478|NCT03011450|147630517|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
74038479|NCT03011450|147630518|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038480|NCT03011450|147630519|SUPERIORITY|||||||0.538|||||||Hodges-Lehmann method|||||||0.5380
74038481|NCT03011450|147630520|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038482|NCT03011450|147630521|SUPERIORITY|||||||0.1165|||||||Hodges-Lehmann method|||||||0.1165
74038483|NCT03011450|147630522|SUPERIORITY|||||||0.0142|||||||Hodges-Lehmann method|||||||0.0142
74038484|NCT03011450|147630523|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038485|NCT03011450|147630524|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038486|NCT03011450|147630525|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038487|NCT03011450|147630526|SUPERIORITY|||||||0.4589|||||||Hodges-Lehmann method|||||||0.4589
74038488|NCT03011450|147630527|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038489|NCT03011450|147630528|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038490|NCT03011450|147630529|OTHER||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038491|NCT03011450|147630530|SUPERIORITY|||||||0.2486|||||||Hodges-Lehmann method|||||||0.2486
74038492|NCT03011450|147630531|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038493|NCT03011450|147630532|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038494|NCT03011450|147630533|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038495|NCT03011450|147630534|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038496|NCT03011450|147630535|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
74038497|NCT03011450|147630536|SUPERIORITY|||||||0.2763|||||||Hodges-Lehmann method|||||||0.2763
74038498|NCT03011450|147630537|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038499|NCT03011450|147630538|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038500|NCT03011450|147630539|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038501|NCT03011450|147630540|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038502|NCT03011450|147630541|SUPERIORITY|||||||0.1651|||||||Hodges-Lehmann method|||||||0.1651
74038503|NCT03011450|147630542|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038504|NCT03011450|147630543|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038505|NCT03011450|147630544|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038506|NCT03011450|147630545|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038507|NCT03011450|147630546|SUPERIORITY|||||||0.5107|||||||Hodges-Lehmann method|||||||0.5107
74038508|NCT03011450|147630547|SUPERIORITY||Hodges-Lehmann method|||||0.0018|||||||Hodges-Lehmann method|||||||0.0018
74038509|NCT03011450|147630548|SUPERIORITY|||||||0.0742|||||||Hodges-Lehmann method|||||||0.0742
74038510|NCT03011450|147630549|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038511|NCT03011450|147630550|SUPERIORITY|||||||0.2707|||||||Hodges-Lehmann method|||||||0.2707
74038512|NCT03011450|147630551|SUPERIORITY|||||||0.0009|||||||Hodges-Lehmann method|||||||0.0009
74038513|NCT03011450|147630552|SUPERIORITY|||||||0.2879|||||||Hodges-Lehmann method|||||||0.2879
73878341|NCT02656017|147295994|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.49|TWO_SIDED|95.0|-2.02|4.25|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in SF-36 MCS as a function of time, the interaction between time and study arm, and clinical site.||4.25|-2.02|0.49
74005893|NCT01821378|147561313|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.2||||0.169|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||||0.09|-0.49|0.169
74005894|NCT01821378|147561313|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.83|-0.32|||Mixed Models Analysis|||||-0.32|-0.83|<0.001
74005895|NCT01821378|147561314|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.3||||0.706|TWO_SIDED|95.0|-1.8|1.2|||ANCOVA|||||1.2|-1.8|0.706
74005896|NCT01821378|147561314|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.0||||0.003|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|||||-0.7|-3.3|0.003
74005897|NCT01821378|147561315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.173|TWO_SIDED|95.0|0.8|2.5|||Regression, Logistic|||||2.5|0.8|0.173
74005898|NCT01821378|147561315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.001|TWO_SIDED|95.0|2.0|5.2|||Regression, Logistic|||||5.2|2.0|<0.001
74005899|NCT01821378|147561316|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.7||||0.023|TWO_SIDED|95.0|-14.3|-1.1|||Mixed Models Analysis|||||-1.1|-14.3|0.023
74005900|NCT01821378|147561317|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.8||||0.464|TWO_SIDED|95.0|-2.9|1.3|||ANCOVA|||||1.3|-2.9|0.464
74038514|NCT03011450|147630553|SUPERIORITY|||||||0.9786|||||||Hodges-Lehmann method|||||||0.9786
74005901|NCT01821378|147561317|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.8||||0.122|TWO_SIDED|95.0|-4.1|0.5|||ANCOVA|||||0.5|-4.1|0.122
74005902|NCT01821378|147561318|SUPERIORITY_OR_OTHER||Least Square Mean Difference|2.3||||0.258|TWO_SIDED|95.0|-1.7|6.2|||Mixed Models Analysis|||||6.2|-1.7|0.258
74005903|NCT01821378|147561318|SUPERIORITY_OR_OTHER||Slope|6.6|||<|0.001|TWO_SIDED|95.0|3.2|10.1|||Mixed Models Analysis|||||10.1|3.2|<0.001
74005904|NCT01821378|147561319|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.35||||0.052|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||||0.00|-0.70|0.052
74005905|NCT01821378|147561320|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.084||||0.012|TWO_SIDED|95.0|0.018|0.149|||ANCOVA|||||0.149|0.018|0.012
74005906|NCT01821378|147561320|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.138|||<|0.001|TWO_SIDED|95.0|0.081|0.194|||ANCOVA|||||0.194|0.081|<0.001
74038515|NCT03011450|147630554|SUPERIORITY|||||||0.0075|||||||Hodges-Lehmann method|||||||0.0075
73878342|NCT02656017|147295995|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare back pain frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.44
73878343|NCT02656017|147295996|SUPERIORITY||Mean Difference (Final Values)|2.73||||0.2|TWO_SIDED|95.0|-1.4|6.87|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in eGFR as a function of time, the interaction between time and study arm, and clinical site.||6.87|-1.40|0.20
74005907|NCT01821378|147561321|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.0||||0.992|TWO_SIDED|95.0|-6.6|6.6|||Mixed Models Analysis|||||6.6|-6.6|0.992
74005908|NCT01821378|147561321|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.3||||0.044|TWO_SIDED|95.0|-14.4|-0.2|||Mixed Models Analysis|||||-0.2|-14.4|0.044
74005909|NCT01821378|147561322|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.578|TWO_SIDED|95.0|-0.45|0.25|||Mixed Models Analysis|||||0.25|-0.45|0.578
74005910|NCT01821378|147561322|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.58||||0.003|TWO_SIDED|95.0|-0.96|-0.2|||Mixed Models Analysis|||||-0.20|-0.96|0.003
74005911|NCT02888665|147561324|OTHER||see above|||||||||||see above. target ORR was not met.|||see above. target ORR was not met.|The primary objective of the phase II design compared ORR with historical rates (Judson et al. Lancet Onc., 2014). A 2-stage design with null hypothesis of 15% using a 1-sided 0.05 α level test has 85% power to detect an increase to 35%. This required up to 35 patients. After 2 responses in stage 1 (20 pts), the study moved to stage 2 (15 pts). If 10 responses were seen (29%), this would have ruled out an ORR of 15%. The study was closed when it became clear we would not meet this benchmark.|see above. target ORR was not met.|||
74005912|NCT01603082|147561346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-159.1|STANDARD_ERROR_OF_MEAN|17.9|<|0.001|TWO_SIDED|95.0|-194.7|-123.5|||t-test, 2 sided||Ticagrelor minus clopidogrel.|||-123.5|-194.7|<0.001
74005913|NCT01603082|147561347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|15.2||0.182|TWO_SIDED|95.0|-50.5|9.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 0.5 hours after the loading dose||9.7|-50.5|0.182
74005914|NCT01603082|147561347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-158.5|STANDARD_ERROR_OF_MEAN|15.5|<|0.001|TWO_SIDED|95.0|-189.4|-127.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 8 hours after the loading dose.||-127.7|-189.4|<0.001
74005915|NCT01603082|147561347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.6|STANDARD_ERROR_OF_MEAN|16.5||0.01|TWO_SIDED|95.0|-76.5|-10.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at end of PCI.||-10.7|-76.5|0.010
74005916|NCT00852592|147561348|SUPERIORITY_OR_OTHER||||||=|0.005|||||||ANOVA|||||||=0.005
74005917|NCT00852592|147561349|SUPERIORITY_OR_OTHER||||||=|0.004|||||||ANOVA|||||||=0.004
74005918|NCT04526197|147561384|OTHER|Confidence Interval|Ratio of geometric LS means|0.881|||||TWO_SIDED|90.0|0.776|1.001||||||||1.001|0.776|
74005919|NCT04526197|147561385|OTHER|Confidence Interval|Ratio of geometric LS means|1.016|||||TWO_SIDED|90.0|0.959|1.077||||||||1.077|0.959|
74005920|NCT04526197|147561386|OTHER|Confidence Interval|Ratio of geometric LS means|1.01|||||TWO_SIDED|90.0|0.954|1.07||||||||1.070|0.954|
74005921|NCT00372385|147561390|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.758||||0.0026|TWO_SIDED|95.0|1.424|5.34|||Regression, Logistic|||||5.340|1.424|0.0026
74005922|NCT00372385|147561390|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.709||||0.959|TWO_SIDED|95.0|0.91|3.212|||Regression, Logistic|||||3.212|0.910|0.959
74038516|NCT03011450|147630555|SUPERIORITY|||||||0.0241|||||||Hodges-Lehmann method|||||||0.0241
74038517|NCT03011450|147630556|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038518|NCT03011450|147630557|SUPERIORITY|||||||0.0502|||||||Hodges-Lehmann method|||||||0.0502
74038519|NCT03011450|147630558|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74038520|NCT03011450|147630559|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
74005923|NCT00372385|147561390|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.589||||0.1089|TWO_SIDED|95.0|0.309|1.125|||Regression, Logistic|||||1.125|0.309|0.1089
74005924|NCT00372385|147561391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.632||||0.0041|TWO_SIDED|95.0|1.359|5.097|||Regression, Logistic|||||5.097|1.359|0.0041
74005925|NCT00372385|147561391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.623||||0.1324|TWO_SIDED|95.0|0.864|3.05|||Regression, Logistic|||||3.050|0.864|0.1324
74005926|NCT00372385|147561391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.591||||0.1099|TWO_SIDED|95.0|0.311|1.126|||Regression, Logistic|||||1.126|0.311|0.1099
74005927|NCT01699789|147561396|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.57|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.95|0.57|
74005928|NCT01699789|147561397|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.48|1.26||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.26|0.48|
74005929|NCT01699789|147561398|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.97||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.|In an analysis of change from baseline in likelihood of Poor Mental Health Quality of Life, CEP showed a significant advantage at 6 months, but not at 12 months.|0.97|0.61|
74005930|NCT01699789|147561399|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.7|2.3||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients at 3 years to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.3|0.7|
74005931|NCT01699789|147561400|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients at 3 years to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.6|
74005932|NCT01699789|147561401|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|1.19|2.59||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.59|1.19|
74005933|NCT01699789|147561402|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.03|2.04||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.04|1.03|
74005934|NCT01699789|147561403|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.14|1.98||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.98|1.14|
74005935|NCT01699789|147561404|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.38|0.96||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.96|0.38|
74005936|NCT01699789|147561405|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.69|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.70|0.69|
74005937|NCT01699789|147561406|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.32|1.09||||||Adjusted analyses used multiply imputed data (N= 249), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||1.09|0.32|
74005938|NCT01699789|147561407|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.28|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.95|0.28|
73878344|NCT02656017|147295997|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.38|TWO_SIDED|95.0|-2.11|5.62|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htTKV) as a function of time, the interaction between time and study arm, and clinical site.||5.62|-2.11|0.38
73878345|NCT02656017|147295998|SUPERIORITY||Mean Difference (Final Values)|3.81||||0.31|TWO_SIDED|95.0|-3.48|11.65|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htTKCV) as a function of time, the interaction between time and study arm, and clinical site.||11.65|-3.48|0.31
73878346|NCT02656017|147295999|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.72|TWO_SIDED|95.0|-1.78|2.61|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htLV) as a function of time, the interaction between time and study arm, and clinical site.||2.61|-1.78|0.72
73878347|NCT02656017|147296000|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.8|TWO_SIDED|95.0|-10.05|14.76|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htLCV) as a function of time, the interaction between time and study arm, and clinical site.||14.76|-10.05|0.80
74005939|NCT01699789|147561408|SUPERIORITY||Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.14|0.88||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.88|0.14|
74005940|NCT01699789|147561409|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.52|1.25|||||Median cut point for baseline variable.|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.25|0.52|
74005941|NCT01699789|147561410|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.69|1.41||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition||1.41|0.69|
74005942|NCT01699789|147561411|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.7|1.46||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.46|0.70|
74005943|NCT01699789|147561412|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.63|||<|0.01|TWO_SIDED|95.0|1.4|4.94|||Regression, Logistic|||Adjusted analyses used multiply imputed data (N=298), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||4.94|1.40|<.01
74008941|NCT01286454|147568261|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|114.7|||||TWO_SIDED|90.0|106.99|122.97||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||122.97|106.99|
73878348|NCT02656017|147296001|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare abdominal fullness interfered as a function of time, the interaction between time and study arm, and clinical site.||||0.83
73878349|NCT02656017|147296002|SUPERIORITY|||||||0.72|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare interference of pain with sleep frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.72
73878350|NCT02656017|147296003|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare interference of pain with strenuous physical activity frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.28
73878351|NCT02792231|147296004|SUPERIORITY||rate ratio|0.416|||<|0.001|TWO_SIDED|95.0|0.309|0.56|||negative binomial regression model|||Obtained from fitting a negative binomial regression model with log-link to the number of relapses, adjusted for treatment and region as factors, number of relapses in previous year, baseline EDSS, baseline number of Gd-enhancing lesions and the patient's age at baseline as covariates. The natural log of the time-in-study was used as offset to annualize the relapse rate.||0.560|0.309|<0.001
73878352|NCT02792231|147296005|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.003|TWO_SIDED|95.0|0.5|0.863|||Regression, Cox|||Pooled data - this study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.863|0.500|0.003
73878353|NCT02792231|147296006|SUPERIORITY||Hazard Ratio (HR)|0.662||||0.038|TWO_SIDED|95.0|0.449|0.977|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.977|0.449|0.038
74005944|NCT01699789|147561413|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.66|1.21||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.21|0.66|
74038521|NCT03011450|147630560|SUPERIORITY|||||||0.0209|||||||Hodges-Lehmann method|||||||0.0209
74038522|NCT03011450|147630561|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74005945|NCT01699789|147561414|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.61|1.4||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.40|0.61|
74005946|NCT01699789|147561415|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.34|1.25||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.25|0.34|
74038523|NCT03011450|147630562|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038524|NCT03011450|147630563|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038525|NCT03011450|147630564|SUPERIORITY||||||<|0.0001|||||||non-parametric Hodges-Lehmann method|||||||<0.0001
74038526|NCT03011450|147630565|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
74038527|NCT03011450|147630566|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
74038528|NCT03956225|147630631|NON_INFERIORITY|Noninferiority in change from baseline in MGS was declared if the lower confidence limit (LCL) was greater than -5.|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.07|||ONE_SIDED|95.0|-2.2||||Mixed effects repeated measures||Standard Error of the Least Squares Mean is presented. Least squares mean difference (iLux minus LipiFlow). Lower Confidence Limit is presented.||||-2.2|
74038529|NCT04093258|147630632|NON_INFERIORITY|Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.|Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.33|6.85|||Generalized Linear Mixed Model Analysis|Finite-sample corrected Akaike's Information Criterion|Odds ratio was calculated as Test/Control|"The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions."||6.85|0.33|
74038530|NCT04093258|147630633|NON_INFERIORITY|Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.|Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.1|1.19|||Generalized Linear Mixed Model Analysis|Finite-sample corrected Akaike's Information Criterion|Odds ratio was calculated as Test over Control|"The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions."||1.19|0.10|
74038531|NCT04093258|147630634|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least square mean difference|-5.98|STANDARD_ERROR_OF_MEAN|3.202|||TWO_SIDED|95.0|-12.48|0.52|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control|||0.52|-12.48|
74038532|NCT00594204|147630635|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.78|||<|0.0001||95.0|2.97|7.68||p-values are obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds Ratios obtained from a logistic regression model including the main effects of treatment and country|||7.68|2.97|<0.0001
74038533|NCT00594204|147630636|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.0001||95.0|3.3|7.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 12||7.5|3.3|<0.0001
74038534|NCT00594204|147630636|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3|||<|0.0001||95.0|2.8|6.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 24||6.5|2.8|<0.0001
74038535|NCT00594204|147630637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.76|||<|0.0001||95.0|3.74|8.88|||Regression, Logistic|p-value are obtained from a logistic regression model including the main effects of treatment and country|Odds Ratios obtained from a logistic regression model including the main effects of treatment and country|||8.88|3.74|<0.0001
74038536|NCT01529385|147630641|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
74038537|NCT01529385|147630642|SUPERIORITY_OR_OTHER||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||<0.05
74038538|NCT01529385|147630643|SUPERIORITY_OR_OTHER||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||<.05
74038539|NCT01529385|147630644|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
74038540|NCT01529385|147630645|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
74038541|NCT01529385|147630646|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
74038542|NCT01529385|147630648|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
74038543|NCT01529385|147630649|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
74038544|NCT01529385|147630650|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
74038545|NCT00321269|147630651|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression analysis- Treatment Arm X Time F (2, 116)=0.09, P\>F=0.90.||||0.90
74091041|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-59.87|STANDARD_ERROR_OF_MEAN|23.0541|||TWO_SIDED|95.0|-105.6|-14.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-14.1|-105.6|
74091042|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-39.96|STANDARD_ERROR_OF_MEAN|22.9336|||TWO_SIDED|95.0|-85.5|5.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.5|-85.5|
74005947|NCT01699789|147561416|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.49|||||TWO_SIDED|95.0|0.3|0.82||||||Adjusted analyses used multiply imputed data (N=553), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||0.82|0.30|
74005948|NCT01699789|147561417|SUPERIORITY||Rate Ratio (RR)|2.84|||||TWO_SIDED|95.0|1.39|5.8||||||Adjusted analyses used multiply imputed data (N=588), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline status of the dependent variable and covariates and accounted for the design effect of the cluster randomization.||5.80|1.39|
74005949|NCT01699789|147561418|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|6.2|||||TWO_SIDED|95.0|1.5|24.9||||||Adjusted analyses used multiply imputed data (N=410), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||24.9|1.5|
74005950|NCT01699789|147561419|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.59|1.57||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.57|0.59|
74005951|NCT01699789|147561420|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.4|1.22|||||When analyzed as change from baseline, CEP showed significant reductions in likelihood of behavioral health hospitalizations at 6 months (P \< 0.01) and 12 months (P \< 0.01).|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.22|.40|
74005952|NCT01699789|147561421|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.66|1.66||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.66|.66|
74005953|NCT01699789|147561422|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.74|1.42||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.42|0.74|
74038546|NCT00321269|147630652|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|F(2,110)=2.08; P=0.13||||||0.13
74038547|NCT01401465|147630684|SUPERIORITY_OR_OTHER||Slope|88.235|||<|0.0001||||||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Two-sided Signed Rank Test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Total Preference Score = 50. Values \> 50 indicate preference for ciclesonide, while values \< 50 indicate preference for mometasone. For the primary endpoint of the Total Preference Score, assuming an SD of 40, a sample size of 155 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.025 two-sided significance level.||||<0.0001
74005954|NCT01699789|147561423|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.6|1.05||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.05|.60|
74005955|NCT01699789|147561424|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.72|1.32||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.32|0.72|
74005956|NCT01699789|147561425|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.39||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.39|0.55|
74005957|NCT01699789|147561426|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.29||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a log link function was used with adjustment for covariates.||1.29|0.65|
74005958|NCT01699789|147561427|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|0.2|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a linear regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|0.2|
74005959|NCT01699789|147561428|SUPERIORITY||Rate Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.1|0.8||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.8|0.1|
74005960|NCT01699789|147561429|SUPERIORITY||Rate Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.4|3.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||3.7|0.4|
74005961|NCT01699789|147561430|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.8|1.5||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.5|0.8|
74005962|NCT01699789|147561431|SUPERIORITY||Rate Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.5|2.1||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.1|0.5|
74005963|NCT01699789|147561432|SUPERIORITY||Rate Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.7|1.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.6|0.7|
74005964|NCT01699789|147561433|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.3|4.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||4.0|0.3|
74005965|NCT01699789|147561434|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.4|2.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.7|0.4|
74005966|NCT01699789|147561435|SUPERIORITY||Rate Ratio (RR)|1.4|||||TWO_SIDED|95.0|0.2|8.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||8.6|0.2|
74005967|NCT01699789|147561436|SUPERIORITY||Rate Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.4|1.8||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.8|0.4|
73878354|NCT02792231|147296007|SUPERIORITY||Hazard Ratio (HR)|0.676||||0.012|TWO_SIDED|95.0|0.498|0.917|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.917|0.498|0.012
73957240|NCT04771273|147450412|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-55.52|||<|0.0001|TWO_SIDED|95.0|-65.61|-45.42||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-45.42|-65.61|<.0001
74005968|NCT01699789|147561437|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.6|1.2|
74005969|NCT01699789|147561438|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.5||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.5|0.5|
74005970|NCT01699789|147561439|SUPERIORITY||Odds Ratio (OR)|2.9|||||TWO_SIDED|95.0|1.0|8.3||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||8.3|1.0|
74005971|NCT01699789|147561440|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.7|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.7|
74005972|NCT01699789|147561441|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.5|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|0.5|
74005973|NCT01699789|147561442|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.0|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|1.0|
74005974|NCT01699789|147561443|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.6|
74005975|NCT01699789|147561444|SUPERIORITY||Cox Proportional Hazard|1.12|||>|0.05|TWO_SIDED|95.0|0.83|1.5|||Regression, Cox|||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Cox proportional-hazards model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||1.50|0.83|>.05
74005976|NCT01699789|147561445|SUPERIORITY||Cox Proportional Hazard|1.23|||>|0.05|TWO_SIDED|95.0|0.99|1.52|||Regression, Cox|||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Cox proportional-hazards model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||1.52|0.99|>0.05
74005977|NCT01699789|147561446|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|1.0|2.99||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||2.99|1.00|
74091043|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-38.99|STANDARD_ERROR_OF_MEAN|23.4683|||TWO_SIDED|95.0|-85.6|7.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.6|-85.6|
73878355|NCT02792231|147296008|SUPERIORITY||Hazard Ratio (HR)|0.759||||0.215|TWO_SIDED|95.0|0.49|1.174|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||1.174|0.490|0.215
73878356|NCT02792231|147296009|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.092|TWO_SIDED|95.0|0.952|1.928|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||1.928|0.952|0.092
73878357|NCT02792231|147296010|SUPERIORITY||Hazard Ratio (HR)|1.523||||0.09|TWO_SIDED|95.0|0.936|2.477|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||2.477|0.936|0.090
74005978|NCT01699789|147561447|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|1.24|5.54||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||5.54|1.24|
74005979|NCT02460666|147561449|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.3
74005980|NCT02460666|147561450|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.2
74005981|NCT02460666|147561451|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
74005982|NCT02460666|147561452|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
74005983|NCT01323621|147561454|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.267||95.0|-0.022|0.08|||ANCOVA||ANCOVA analysis was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.|||0.080|-0.022|0.267
74005984|NCT02876835|147561473|NON_INFERIORITY|Non-inferiority was achieved if the upper limit of the two-sided 95% CI for the hazard ratio was below the pre-specified non-inferiority margin of 1.25.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.89|1.19|||||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.19|0.89|
74005985|NCT02876835|147561474|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than -0.75 g/dL.|Least square (LS) mean difference|0.08|||||TWO_SIDED|95.0|0.03|0.13||||||||0.13|0.03|
74005986|NCT02876835|147561475|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.670884|TWO_SIDED|95.0|0.89|1.19||The p-value was compared against 0.008333 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.19|0.89|0.670884
74005987|NCT02876835|147561476|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.800813|TWO_SIDED|95.0|0.93|1.22||The p-value was compared against 0.012500 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.22|0.93|0.800813
74005988|NCT02876835|147561477|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.886195|TWO_SIDED|95.0|0.95|1.24||The p-value was compared against 0.025000 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.24|0.95|0.886195
74039861|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.18||0.027|TWO_SIDED|95.0|-0.77|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.77|0.0270
73878358|NCT02792231|147296011|SUPERIORITY||rate ratio|0.061|||<|0.001|TWO_SIDED|95.0|0.037|0.101|||negative binomial regression model|||||0.101|0.037|<.001
73878359|NCT02792231|147296012|SUPERIORITY||rate ratio|0.21|||<|0.001|TWO_SIDED|95.0|0.17|0.27|||negative binomial regression model|||Month 12||0.27|0.17|<.001
73878360|NCT02792231|147296012|SUPERIORITY||rate ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.31|||negative binomial regression model|||Month 24||0.31|0.12|<.001
73878361|NCT02792231|147296012|SUPERIORITY||rate ratio|0.15|||<|0.001|TWO_SIDED|95.0|0.13|0.19|||negative binomial regression model|||End of Study||0.19|0.13|<.001
73878362|NCT02792231|147296013|SUPERIORITY||Geo-mean ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.85|0.93|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 3||0.93|0.85|<.001
73878363|NCT02792231|147296013|SUPERIORITY||Geo-mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.7|0.79|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 12||0.79|0.70|<.001
73878364|NCT02792231|147296013|SUPERIORITY||Geo-mean ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.71|0.81|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 24||0.81|0.71|<.001
74005989|NCT02876835|147561478|SUPERIORITY||Subdistribution hazard ratio|0.98||||0.36947|TWO_SIDED|95.0|0.84|1.13|||Wald test||Subdistribution hazard ratio was estimated using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.13|0.84|0.369470
74005990|NCT02876835|147561479|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6197|TWO_SIDED|95.0|0.87|1.2|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.20|0.87|0.6197
74005991|NCT02876835|147561480|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.8976|TWO_SIDED|95.0|0.91|1.58|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.58|0.91|0.8976
74005992|NCT02876835|147561481|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6581|TWO_SIDED|95.0|0.8|1.4|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.40|0.80|0.6581
74005993|NCT02876835|147561482|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.894|TWO_SIDED|95.0|0.85|2.07|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||2.07|0.85|0.8940
74005994|NCT02876835|147561483|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.9422|TWO_SIDED|95.0|0.98|1.23|||Chi-squared||Overall HR is presented using Model 1. Model 1 assumed a common treatment effect, regardless of number of events experienced. HR was estimated using a Prentice, Williams and Peterson(PWP) model, with treatment, dialysis type and region as covariates.|||1.23|0.98|0.9422
74038548|NCT01401465|147630685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.9|||<|0.0001|TWO_SIDED|95.0|11.22|16.58||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline.||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.||16.58|11.22|<0.0001
74038549|NCT01401465|147630685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.88|||<|0.0001|TWO_SIDED|95.0|2.2|7.56||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.||7.56|2.20|<0.0001
74038550|NCT01401465|147630686|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|88.889|||<|0.0001||||||If both primary endpoints are significant, the evaluation of this key secondary endpoint will be conducted at a significance level of 0.05.|Two-sided signed-rank test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Treatment Process Composite Preference Score = 50. Values \> 50 indicate preference for ciclesonide, while values \< 50 indicate preference for mometasone. Assuming an SD of 40, as observed in Study 060-301, a sample size of 128 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.05 two-sided significant level||||<0.0001
74038551|NCT01401465|147630687|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CI of the LS mean difference of ciclesonide nasal aerosol minus mometasone aqueous nasal spray was calculated from the ANCOVA model, and the upper bound of the CI was compared to the non-inferiority margin of 0.5. Non-inferiority was declared if the upper bound of the 95% CI of this difference was \< 0.5.|Difference in LS Means|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||f both primary endpoints are significant, the evaluation of this key secondary endpoint will be conducted at a significance level of 0.05.|ANCOVA|Site, treatment, period, treatment sequence as fixed effects, subject nested within sequence as a random effect, and baseline rTNSS as a covariate.|Ciclesonide 74 mcg minus Mometasone 200 mcg|The null hypothesis is that the change from baseline in rTNSS for ciclesonide 74 mcg nasal aerosol minus the change from baseline in rTNSS for mometasone AQ 200 mcg is greater than 0.5.||0.1|-0.3|
74038552|NCT01115738|147630715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.24||||0.188|TWO_SIDED|95.0|-10.98|55.47||P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||55.47|-10.98|0.188
74038553|NCT01115738|147630715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93||||0.809|TWO_SIDED|95.0|-28.2|36.07||P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||36.07|-28.20|0.809
74038554|NCT01115738|147630716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.93||||0.37|TWO_SIDED|95.0|-20.26|54.12||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||54.12|-20.26|0.370
74038555|NCT01115738|147630716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.89||||0.052|TWO_SIDED|95.0|-0.29|72.06||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||72.06|-0.29|0.052
74038556|NCT01115738|147630716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45||||0.703|TWO_SIDED|95.0|-39.55|58.45||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||58.45|-39.55|0.703
74038557|NCT01115738|147630716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.45||||0.823|TWO_SIDED|95.0|-42.53|53.44||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||53.44|-42.53|0.823
74091044|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-63.69|STANDARD_ERROR_OF_MEAN|27.3484|||TWO_SIDED|95.0|-118.1|-9.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-9.3|-118.1|
74091045|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-61.36|STANDARD_ERROR_OF_MEAN|27.2866|||TWO_SIDED|95.0|-115.6|-7.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-7.2|-115.6|
74091046|NCT02037165|147735944|SUPERIORITY_OR_OTHER||adjusted mean difference|-49.4|STANDARD_ERROR_OF_MEAN|26.7541|||TWO_SIDED|95.0|-102.6|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-102.6|
74091047|NCT00532935|147735945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|1.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.28|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline A1C value.||||-0.28|-0.66|<0.001
74091048|NCT00532935|147735946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.6|STANDARD_DEVIATION|29.1|<|0.001|TWO_SIDED|95.0|-32.7|-22.4|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.||||-22.4|-32.7|<0.001
74038558|NCT01115738|147630716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.69||||0.054|TWO_SIDED|95.0|-0.47|57.84||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||57.84|-0.47|0.054
74091049|NCT00532935|147735947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.2|STANDARD_DEVIATION|59.7|<|0.001|TWO_SIDED|95.0|-32.1|-8.3|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline 2-hour PMG value.||||-8.3|-32.1|<0.001
74091050|NCT00532935|147735948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.9|STANDARD_DEVIATION|40.3|<|0.001|TWO_SIDED|95.0|-19.0|-4.9|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.||||-4.9|-19.0|<0.001
74091051|NCT00532935|147735949|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.3|2.8||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.|Regression, Logistic|logistic regression model included a term for treatment and a covariate for the baseline A1C value.|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.|||2.8|1.3|<0.001
74091052|NCT02192164|147735952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.757334|STANDARD_ERROR_OF_MEAN|1.594019|||TWO_SIDED|95.0|-5.916307|0.401638||||||||0.401638|-5.916307|
74091053|NCT02192164|147735953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.911449|STANDARD_ERROR_OF_MEAN|1.426517|||TWO_SIDED|95.0|-3.73847|1.915572||||||||1.915572|-3.73847|
74038559|NCT01115738|147630716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3||||0.436|TWO_SIDED|95.0|-17.29|39.9||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||39.90|-17.29|0.436
74091054|NCT01568866|147735967|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.533|||<|0.0001|TWO_SIDED|95.0|0.437|0.651|||Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|"The PFS interim analysis was to be performed using a group sequential monitoring plan.~The monitoring plan included an O'Brien-Fleming type of efficacy stopping boundary constructed using the Lan-DeMets alpha spending function to ensure a 1-sided Type I error rate ≤ 0.025."||0.651|0.437|< 0.0001
74091055|NCT01568866|147735968|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.791||||0.01|TWO_SIDED|95.0|0.648|0.964||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|The second interim analysis of overall survival was to be conducted after 394 events had been reached. A one-sided significance level was determined using the O'Brien-Fleming-type α spending function based on the actual number of events (α=0.0123).||0.964|0.648|0.0100
74005995|NCT02876835|147561483|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8862|TWO_SIDED|95.0|0.95|1.24|||Chi-squared||First Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. Hazard Ratio (HR) was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.24|0.95|0.8862
74005996|NCT02876835|147561483|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6789|TWO_SIDED|95.0|0.82|1.39|||Chi-squared||Second Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.39|0.82|0.6789
74005997|NCT02876835|147561483|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.9016|TWO_SIDED|95.0|0.85|2.19|||Chi-squared||Third Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||2.19|0.85|0.9016
74005998|NCT02876835|147561483|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8862|TWO_SIDED|95.0|0.95|1.24|||Chi-squared||First Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.24|0.95|0.8862
74005999|NCT02876835|147561483|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.8989|TWO_SIDED|95.0|0.92|1.46|||Chi-squared||Subsequent Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.46|0.92|0.8989
74006000|NCT02876835|147561484|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.7673|TWO_SIDED|95.0|0.88|1.33|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.33|0.88|0.7673
74006001|NCT02876835|147561485|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.8601|TWO_SIDED|95.0|0.96|1.15|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.15|0.96|0.8601
74006002|NCT02876835|147561486|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6207|TWO_SIDED|95.0|0.86|1.22|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.22|0.86|0.6207
74006003|NCT02876835|147561487|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.9393|TWO_SIDED|95.0|0.97|1.26|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.26|0.97|0.9393
74006004|NCT02876835|147561488|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.9412|TWO_SIDED|95.0|0.95|1.56|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.56|0.95|0.9412
74006005|NCT02876835|147561489|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.8994|TWO_SIDED|95.0|0.88|1.84|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.84|0.88|0.8994
74006006|NCT02876835|147561490|SUPERIORITY||Subdistribution hazard ratio|0.92||||0.2073|TWO_SIDED|95.0|0.75|1.13|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.13|0.75|0.2073
74006007|NCT02876835|147561491|SUPERIORITY||Subdistribution hazard ratio|1.0||||0.5068|TWO_SIDED|95.0|0.84|1.19|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.19|0.84|0.5068
74006008|NCT02876835|147561492|SUPERIORITY||Subdistribution hazard ratio|0.88||||0.3285|TWO_SIDED|95.0|0.51|1.54|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.54|0.51|0.3285
74006009|NCT02876835|147561493|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.03|||||TWO_SIDED|95.0|-0.05|0.11||||||||0.11|-0.05|
74006010|NCT02876835|147561494|SUPERIORITY||Difference in response rate|8.3|||<|0.0001|TWO_SIDED|95.0|5.2|11.4|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test adjusted for current ESA use and region was used to compare the number of responders between the treatment groups.|||11.4|5.2|<0.0001
74006011|NCT02876835|147561495|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Mean Difference (Final Values)|4.57|||||TWO_SIDED|95.0|2.04|7.11|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.|||7.11|2.04|
74006012|NCT02876835|147561496|SUPERIORITY||Probability|0.55|||<|0.0001|TWO_SIDED|95.0|0.53|0.57|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.57|0.53|<0.0001
74006013|NCT02876835|147561497|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|3.94|||||TWO_SIDED|95.0|1.9|5.91|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.|||5.91|1.90|
74006014|NCT02876835|147561498|SUPERIORITY||Probability|0.54|||<|0.0001|TWO_SIDED|95.0|0.52|0.56|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.56|0.52|<0.0001
74006015|NCT02876835|147561499|SUPERIORITY||LS mean difference|0.56||||0.7916|TWO_SIDED|95.0|-0.79|1.9|||MMRM||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.90|-0.79|0.7916
74006016|NCT02876835|147561499|SUPERIORITY||LS mean difference|0.65||||0.9581|TWO_SIDED|95.0|-0.09|1.38|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.38|-0.09|0.9581
74006017|NCT02876835|147561499|SUPERIORITY||LS mean difference|0.6||||0.9241|TWO_SIDED|95.0|-0.22|1.43|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.43|-0.22|0.9241
74006018|NCT02876835|147561500|SUPERIORITY||LS mean difference|-0.08||||0.442|TWO_SIDED|95.0|-1.18|1.02|||ANCOVA||For SBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||1.02|-1.18|0.4420
74006019|NCT02876835|147561500|SUPERIORITY||LS mean difference|0.11||||0.6369|TWO_SIDED|95.0|-0.52|0.75|||ANCOVA||For DBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||0.75|-0.52|0.6369
74038560|NCT01115738|147630716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.87||||0.463|TWO_SIDED|95.0|-14.96|32.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||32.71|-14.96|0.463
74038561|NCT01115738|147630716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.34||||0.777|TWO_SIDED|95.0|-26.62|19.94||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||19.94|-26.62|0.777
74038562|NCT01115738|147630719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31||||0.505|TWO_SIDED|95.0|-13.1|6.48||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||6.48|-13.10|0.505
74038563|NCT01115738|147630719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.23||||0.278|TWO_SIDED|95.0|-14.74|4.27||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||4.27|-14.74|0.278
74038564|NCT01115738|147630719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.749|TWO_SIDED|95.0|-19.44|14.02||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||14.02|-19.44|0.749
74038565|NCT01115738|147630719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.89|TWO_SIDED|95.0|-15.24|17.53||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||17.53|-15.24|0.890
74038566|NCT01115738|147630719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.89||||0.223|TWO_SIDED|95.0|-18.02|4.24||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||4.24|-18.02|0.223
74038567|NCT01115738|147630719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.808|TWO_SIDED|95.0|-9.44|12.1||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||12.10|-9.44|0.808
74038568|NCT01115738|147630719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.07||||0.049|TWO_SIDED|95.0|-20.11|-0.04||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||-0.04|-20.11|0.049
74038569|NCT01115738|147630719|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.99||||0.842|TWO_SIDED|95.0|-10.85|8.86||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||8.86|-10.85|0.842
74038570|NCT01115738|147630719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.03||||0.247|TWO_SIDED|95.0|-13.58|3.52||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||3.52|-13.58|0.247
74038571|NCT01115738|147630719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.942|TWO_SIDED|95.0|-8.09|8.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||8.71|-8.09|0.942
74006020|NCT02876835|147561500|SUPERIORITY||LS mean difference|0.04||||0.549|TWO_SIDED|95.0|-0.65|0.74|||ANCOVA||For MAP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||0.74|-0.65|0.5490
74006021|NCT02876835|147561501|SUPERIORITY||Ratio of exacerbation rate|0.88||||0.0074|TWO_SIDED|95.0|0.79|0.98|||Negative binomial model||Ratio of model estimated exacerbation rates and CIs estimated using negative binomial model with treatment,current ESA use at randomization and region as covariates and logarithm of time on treatment as offset variable for treatment group comparison.|||0.98|0.79|0.0074
74006022|NCT02876835|147561503|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0113|TWO_SIDED|95.0|0.42|0.94|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, current ESA use and region.|||0.94|0.42|0.0113
74006023|NCT02876835|147561504|SUPERIORITY||LS mean difference|-0.36||||0.932|TWO_SIDED|95.0|-0.83|0.11|||MMRM||Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time,current ESA use at randomization, region,Baseline value and Baseline value by time and treatment by time interactions|||0.11|-0.83|0.9320
74006024|NCT02876835|147561504|SUPERIORITY||LS mean difference|-0.11||||0.6761|TWO_SIDED|95.0|-0.59|0.36|||MMRM||Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.36|-0.59|0.6761
74006025|NCT02876835|147561504|SUPERIORITY||LS mean difference|0.12||||0.3335|TWO_SIDED|95.0|-0.43|0.67|||MMRM||Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.67|-0.43|0.3335
74006026|NCT02876835|147561504|SUPERIORITY||LS mean difference|-0.2||||0.7423|TWO_SIDED|95.0|-0.81|0.41|||MMRM||Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.41|-0.81|0.7423
74006027|NCT02876835|147561505|SUPERIORITY||LS mean difference|-0.29||||0.8268|TWO_SIDED|95.0|-0.9|0.32|||MMRM||Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions.|||0.32|-0.90|0.8268
74006028|NCT02876835|147561505|SUPERIORITY||LS mean difference|-0.15||||0.6851|TWO_SIDED|95.0|-0.77|0.47|||MMRM||Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.47|-0.77|0.6851
74006029|NCT02876835|147561505|SUPERIORITY||LS mean difference|-0.33||||0.8316|TWO_SIDED|95.0|-1.01|0.35|||MMRM||Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.35|-1.01|0.8316
74006030|NCT02876835|147561505|SUPERIORITY||LS mean difference|-0.35||||0.8032|TWO_SIDED|95.0|-1.16|0.46|||MMRM||Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.46|-1.16|0.8032
74006031|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.34||||0.8562|TWO_SIDED|95.0|-0.95|0.28|||MMRM||B pain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.28|-0.95|0.8562
74006032|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.15||||0.6849|TWO_SIDED|95.0|-0.77|0.47|||MMRM||B pain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.47|-0.77|0.6849
74006033|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.49||||0.9074|TWO_SIDED|95.0|-1.22|0.24|||MMRM||B pain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.24|-1.22|0.9074
74006034|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.47||||0.8765|TWO_SIDED|95.0|-1.26|0.32|||MMRM||B pain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.32|-1.26|0.8765
74006035|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.08||||0.6252|TWO_SIDED|95.0|-0.56|0.4|||MMRM||GH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.40|-0.56|0.6252
74006036|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.2||||0.7852|TWO_SIDED|95.0|-0.68|0.29|||MMRM||GH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.29|-0.68|0.7852
74038572|NCT01115738|147630722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.449||||0.8711|TWO_SIDED|95.0|-38.81|45.71|||ANOVA|||A linear ANOVA model with PRU values at baseline for clopidogrel treated participants as response and CYP2C19 metabolizer status as covariate of main interest.||45.71|-38.81|0.8711
74038573|NCT01115738|147630723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.714||||0.7875|TWO_SIDED|95.0|-72.78|55.36|||ANOVA|||A linear ANOVA model with PRU values of 6 hours post Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||55.36|-72.78|0.7875
74038574|NCT01115738|147630723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.435||||0.8913|TWO_SIDED|95.0|-53.23|46.37|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||46.37|-53.23|0.8913
73878365|NCT02792231|147296014|SUPERIORITY||Mean Difference (Net)|0.07||||0.128|TWO_SIDED|95.0|-0.02|0.15|||random coefficient model|||||0.15|-0.02|0.128
73878366|NCT02792231|147296017|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.002|TWO_SIDED|95.0|0.486|0.847|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.847|0.486|0.002
73878367|NCT02792231|147296018|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.008|TWO_SIDED|95.0|0.481|0.898|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.898|0.481|0.008
73878368|NCT00558246|147296115|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|Differences in proportion of successes|0.0||||1|TWO_SIDED|95.0|-5.9|5.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.|||5.9|-5.9|1.0000
73878369|NCT00558246|147296116|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74006037|NCT02876835|147561506|SUPERIORITY||LS mean difference|0.1||||0.3614|TWO_SIDED|95.0|-0.46|0.66|||MMRM||GH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.66|-0.46|0.3614
74006038|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.08||||0.5991|TWO_SIDED|95.0|-0.7|0.54|||MMRM||GH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.54|-0.70|0.5991
74006039|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.31||||0.8526|TWO_SIDED|95.0|-0.88|0.27|||MMRM||MH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.27|-0.88|0.8526
74006040|NCT02876835|147561506|SUPERIORITY||LS mean difference|0.02||||0.4673|TWO_SIDED|95.0|-0.56|0.61|||MMRM||MH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.61|-0.56|0.4673
74006041|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.31||||0.8262|TWO_SIDED|95.0|-0.95|0.33|||MMRM||MH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.33|-0.95|0.8262
74006042|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.25||||0.738|TWO_SIDED|95.0|-1.0|0.51|||MMRM||MH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.51|-1.00|0.7380
74006043|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.09||||0.5997|TWO_SIDED|95.0|-0.8|0.62|||MMRM||RE,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.62|-0.80|0.5997
74006044|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.26||||0.7649|TWO_SIDED|95.0|-0.98|0.45|||MMRM||RE,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.45|-0.98|0.7649
74006045|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.37||||0.8175|TWO_SIDED|95.0|-1.18|0.43|||MMRM||RE,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.43|-1.18|0.8175
74006046|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.52||||0.8591|TWO_SIDED|95.0|-1.47|0.43|||MMRM||RE,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.43|-1.47|0.8591
74006047|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.5||||0.9588|TWO_SIDED|95.0|-1.06|0.06|||MMRM||RP,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.06|-1.06|0.9588
74006048|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.33||||0.8761|TWO_SIDED|95.0|-0.9|0.23|||MMRM||RP,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.23|-0.90|0.8761
73878370|NCT00558246|147296117|SUPERIORITY_OR_OTHER|||||||1||95.0|||||McNemar|||||||1.0000
73878371|NCT00558246|147296118|SUPERIORITY_OR_OTHER|||||||0.2266|||||||McNemar|||||||0.2266
73878372|NCT00558246|147296119|SUPERIORITY_OR_OTHER|||||||0.5078||0.0|||||McNemar|||||||0.5078
74006049|NCT02876835|147561506|SUPERIORITY||LS mean difference|0.06||||0.4293|TWO_SIDED|95.0|-0.58|0.7|||MMRM||RP,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.70|-0.58|0.4293
74038575|NCT01115738|147630723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7||||0.6229|TWO_SIDED|95.0|-35.43|58.83|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||58.83|-35.43|0.6229
74038576|NCT04009213|147630730|NON_INFERIORITY|H0: δT - δC ≥ 0.9 Ha: δT - δC \< 0.9|||||<|0.025|ONE_SIDED|95.0|||||ANCOVA|||||||< 0.025
74038577|NCT04009213|147630731|NON_INFERIORITY|H0: qT - qC ≥ 10% H1: qT - qC \< 10%|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||< 0.025
74006050|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.19||||0.6983|TWO_SIDED|95.0|-0.92|0.53|||MMRM||RP,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.53|-0.92|0.6983
74006051|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.62||||0.9743|TWO_SIDED|95.0|-1.25|0.0|||MMRM||SF,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.00|-1.25|0.9743
74006052|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.32||||0.8405|TWO_SIDED|95.0|-0.94|0.31|||MMRM||SF,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.31|-0.94|0.8405
74006053|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.13||||0.6459|TWO_SIDED|95.0|-0.82|0.56|||MMRM||SF,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.56|-0.82|0.6459
74006054|NCT02876835|147561506|SUPERIORITY||LS mean difference|-0.38||||0.8272|TWO_SIDED|95.0|-1.17|0.41|||MMRM||SF,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.41|-1.17|0.8272
74006055|NCT02876835|147561507|SUPERIORITY||LS mean difference|-0.56||||0.9786|TWO_SIDED|95.0|-1.09|-0.02|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||-0.02|-1.09|0.9786
74006056|NCT02876835|147561507|SUPERIORITY||LS mean difference|-0.12||||0.6642|TWO_SIDED|95.0|-0.68|0.44|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.44|-0.68|0.6642
74006057|NCT02876835|147561507|SUPERIORITY||LS mean difference|-0.1||||0.6261|TWO_SIDED|95.0|-0.72|0.52|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.52|-0.72|0.6261
74006058|NCT02876835|147561507|SUPERIORITY||LS mean difference|-0.49||||0.9161|TWO_SIDED|95.0|-1.19|0.21|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.21|-1.19|0.9161
74038578|NCT04009213|147630732|NON_INFERIORITY|H0: pC - pT ≥ 10% H1: pC - pT \< 10%,|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||<0.025
74038579|NCT04009213|147630733|NON_INFERIORITY|H0: πC - πT ≥ 15% H1: πC - πT \< 15%,|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||< 0.025
74006059|NCT02876835|147561508|SUPERIORITY||LS mean difference|-0.32||||0.8703|TWO_SIDED|95.0|-0.88|0.24|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.24|-0.88|0.8703
74038580|NCT01709981|147630742|EQUIVALENCE|Mann-Whitney||||||0.31|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.31
74038581|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.42|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-77.55|-65.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.29|-77.55|<0.001
74038582|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.16|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-65.94|-52.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-52.38|-65.94|<0.001
74038583|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.6|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-45.81|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.40|-45.81|<0.001
74006060|NCT02876835|147561508|SUPERIORITY||LS mean difference|0.13||||0.3167|TWO_SIDED|95.0|-0.41|0.67|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.67|-0.41|0.3167
74006061|NCT02876835|147561508|SUPERIORITY||LS mean difference|0.15||||0.3155|TWO_SIDED|95.0|-0.47|0.78|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.78|-0.47|0.3155
74006062|NCT02876835|147561508|SUPERIORITY||LS mean difference|-0.32||||0.8069|TWO_SIDED|95.0|-1.06|0.41|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.41|-1.06|0.8069
74006063|NCT02876835|147561509|SUPERIORITY||LS mean difference|-0.0234||||0.9724|TWO_SIDED|95.0|-0.0474|0.0005|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.0005|-0.0474|0.9724
74006064|NCT02876835|147561510|SUPERIORITY||LS mean difference|0.7||||0.2687|TWO_SIDED|95.0|-1.5|2.9|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||2.9|-1.5|0.2687
74006065|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.22||||0.978|TWO_SIDED|95.0|-2.4|-0.03|||MMRM||Tired/LE/Weak domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-2.40|0.9780
74006066|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.97||||0.943|TWO_SIDED|95.0|-2.18|0.23|||MMRM||Tired/LE/Weak domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.23|-2.18|0.9430
74038584|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.1|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-47.83|-34.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-34.37|-47.83|<0.001
74038585|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-76.29|STANDARD_ERROR_OF_MEAN|5.36|<|0.001|TWO_SIDED|95.0|-86.87|-65.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.72|-86.87|<0.001
74038586|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.51|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-79.81|-61.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.20|-79.81|<0.001
74038587|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.2|STANDARD_ERROR_OF_MEAN|5.24|<|0.001|TWO_SIDED|95.0|-57.54|-36.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-36.86|-57.54|<0.001
74038588|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.88|STANDARD_ERROR_OF_MEAN|4.73|<|0.001|TWO_SIDED|95.0|-48.21|-29.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-29.56|-48.21|<0.001
74091056|NCT01568866|147735969|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.032|||<|0.0001|TWO_SIDED|95.0|1.519|2.718||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by the randomization stratification factors.|The odds ratio (carfilzomib/bortezomib) was calculated using the Cochran-Mantel-Haenszel method stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|||2.718|1.519|< 0.0001
74091057|NCT01568866|147735971|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.137|||<|0.0001|TWO_SIDED|95.0|0.089|0.21||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Cochran-Mantel-Haenszel||The odds ratio (carfilzomib/bortezomib) was estimated using the unconditional Cochran-Mantel-Haenszel method.|||0.210|0.089|<0.0001
74091058|NCT01698775|147735979|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.33||||0.035|TWO_SIDED|95.0|-0.63|-0.02|||ANCOVA|||||-0.02|-0.63|0.035
74006067|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.6||||0.8042|TWO_SIDED|95.0|-1.98|0.77|||MMRM||Tired/LE/Weak domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.77|-1.98|0.8042
74006068|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.57||||0.977|TWO_SIDED|95.0|-3.11|-0.03|||MMRM||Tired/LE/Weak domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-3.11|0.9770
74006069|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.2||||0.9905|TWO_SIDED|95.0|-2.2|-0.2|||MMRM||CP/SOB,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.20|-2.20|0.9905
74006070|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.65||||0.8939|TWO_SIDED|95.0|-1.67|0.37|||LS mean difference||CP/SOB,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.37|-1.67|0.8939
74006071|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.52||||0.807|TWO_SIDED|95.0|-1.7|0.66|||MMRM||CP/SOB,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.66|-1.70|0.8070
74006072|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.18||||0.9615|TWO_SIDED|95.0|-2.49|0.13|||MMRM||CP/SOB,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.13|-2.49|0.9615
74006073|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.76||||0.9015|TWO_SIDED|95.0|-1.91|0.39|||MMRM||Cog domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.39|-1.91|0.9015
74006074|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.18||||0.9781|TWO_SIDED|95.0|-2.32|-0.03|||MMRM||Cog domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-2.32|0.9781
74006075|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.77||||0.8778|TWO_SIDED|95.0|-2.07|0.53|||MMRM||Cog domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.53|-2.07|0.8778
74006076|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.65||||0.9864|TWO_SIDED|95.0|-3.11|-0.19|||MMRM||Cog domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.19|-3.11|0.9864
74006077|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.1||||0.9725|TWO_SIDED|95.0|-2.3|0.0|||MMRM||SOB, no activity,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.3|0.9725
74006078|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.3||||0.7188|TWO_SIDED|95.0|-1.5|0.8|||MMRM||SOB, no activity,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.8|-1.5|0.7188
74038589|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.21|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-74.72|-61.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.70|-74.72|<0.001
74006079|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.9||||0.8903|TWO_SIDED|95.0|-2.3|0.5|||MMRM||SOB, no activity,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.5|-2.3|0.8903
74006080|NCT02876835|147561511|SUPERIORITY||LS mean difference|0.0||||0.5011|TWO_SIDED|95.0|-1.6|1.6|||MMRM||SOB, no activity,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||1.6|-1.6|0.5011
74006081|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.1||||0.9716|TWO_SIDED|95.0|-2.2|0.0|||MMRM||S-SB,Resting, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.2|0.9716
74006082|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.3||||0.6908|TWO_SIDED|95.0|-1.4|0.9|||MMRM||S-SB,Resting, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-1.4|0.6908
74006083|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.5||||0.7462|TWO_SIDED|95.0|-1.8|0.9|||MMRM||S-SB,Resting, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-1.8|0.7462
74006084|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.5||||0.977|TWO_SIDED|95.0|-2.9|0.0|||MMRM||S-SB,Resting, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.9|0.9770
74006085|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.4||||0.9471|TWO_SIDED|95.0|-3.2|0.3|||MMRM||Diff std for LT, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.3|-3.2|0.9471
74006086|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.9||||0.833|TWO_SIDED|95.0|-2.6|0.9|||MMRM||Diff std for LT, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-2.6|0.8330
74006087|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.2||||0.8918|TWO_SIDED|95.0|-3.2|0.7|||MMRM||Diff std for LT, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.7|-3.2|0.8918
74006088|NCT02876835|147561511|SUPERIORITY||LS mean difference|-3.2||||0.9986|TWO_SIDED|95.0|-5.4|-1.1|||MMRM||Diff std for LT, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-1.1|-5.4|0.9986
74006089|NCT02876835|147561511|SUPERIORITY||LS mean difference|0.4||||0.3035|TWO_SIDED|95.0|-1.2|2.1|||MMRM||Diff sleep, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||2.1|-1.2|0.3035
74006090|NCT02876835|147561511|SUPERIORITY||LS mean difference|-1.4||||0.9563|TWO_SIDED|95.0|-3.1|0.2|||MMRM||Diff sleep, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.2|-3.1|0.9563
74006091|NCT02876835|147561511|SUPERIORITY||LS mean difference|-0.4||||0.6548|TWO_SIDED|95.0|-2.3|1.5|||MMRM||Diff sleep, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||1.5|-2.3|0.6548
74006092|NCT02876835|147561511|SUPERIORITY||LS mean difference|-2.4||||0.9832|TWO_SIDED|95.0|-4.5|-0.2|||MMRM||Diff sleep, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.2|-4.5|0.9832
74006093|NCT02876835|147561512|SUPERIORITY||LS mean difference|0.02||||0.6917|TWO_SIDED|95.0|-0.05|0.08|||MMRM||Week 8: Model was fitted from Baseline up to Week52 and model adjusted Week 8 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.08|-0.05|0.6917
74006094|NCT02876835|147561512|SUPERIORITY||LS mean difference|0.05||||0.951|TWO_SIDED|95.0|-0.01|0.11|||MMRM||Week 12: Model was fitted from Baseline up to Week52 and model adjusted Week 12 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.11|-0.01|0.9510
74006095|NCT02876835|147561512|SUPERIORITY||LS mean difference|-0.04||||0.1136|TWO_SIDED|95.0|-0.11|0.03|||MMRM||Week 28: Model was fitted from Baseline up to Week52 and model adjusted Week 28 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.11|0.1136
74006096|NCT02876835|147561512|SUPERIORITY||LS mean difference|0.05||||0.8859|TWO_SIDED|95.0|-0.03|0.13|||MMRM||Week 52: Model was fitted from Baseline up to Week52 and model adjusted Week 52 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.13|-0.03|0.8859
74006097|NCT02876835|147561513|SUPERIORITY||LS mean difference|-0.2||||0.7716|TWO_SIDED|95.0|-0.74|0.33|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use at randomization, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.33|-0.74|0.7716
74006098|NCT01313650|147561537|SUPERIORITY_OR_OTHER||Least squares mean difference|0.115|||<|0.001|TWO_SIDED|95.0|0.076|0.155|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 62.5 µg minus Placebo.|||0.155|0.076|<0.001
74006099|NCT01313650|147561537|SUPERIORITY_OR_OTHER||Least squares mean difference|0.072|||<|0.001|TWO_SIDED|95.0|0.032|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.|||0.112|0.032|<0.001
74006100|NCT01313650|147561537|SUPERIORITY_OR_OTHER||Least squares mean difference|0.167|||<|0.001|TWO_SIDED|95.0|0.128|0.207|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.207|0.128|<0.001
74039862|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.0019|TWO_SIDED|95.0|-0.94|-0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.21|-0.94|0.0019
74006101|NCT01313650|147561537|SUPERIORITY_OR_OTHER||Least squares mean difference|0.052||||0.004|TWO_SIDED|95.0|0.017|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus UMEC 62.5 µg.|||0.087|0.017|0.004
74006102|NCT01313650|147561537|SUPERIORITY_OR_OTHER||Least squares mean difference|0.095|||<|0.001|TWO_SIDED|95.0|0.06|0.13|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus VI 25 µg.|||0.130|0.060|<0.001
74006103|NCT03153111|147561555|SUPERIORITY||Geometric mean ratio|1.02||||0.7923|TWO_SIDED|90.0|0.88|1.19|||ANCOVA|||||1.19|0.88|0.7923
74006104|NCT03153111|147561556|SUPERIORITY||Least square mean difference|-3.5|STANDARD_ERROR_OF_MEAN|2.82||0.2172|TWO_SIDED|90.0|-8.17|1.17|||ANCOVA|||||1.17|-8.17|0.2172
74006105|NCT03153111|147561557|SUPERIORITY||Least square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3665|TWO_SIDED|90.0|-0.05|0.02|||ANCOVA|||||0.02|-0.05|0.3665
74006106|NCT01389765|147561559|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.01|||||TWO_SIDED|90.0|0.97|1.05|||Mixed Models Analysis|Analyzed was a ratio of geometric LS means between the 2 treatment states (fed/fasted), and the 90% confidence interval for the ratio.||||1.05|0.97|
74006107|NCT01389765|147561560|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.96|||||TWO_SIDED|90.0|0.92|1.01|||Mixed Models Analysis|Analyzed was a ratio of geometric LS means between the 2 treatments states (fed/fasted), and the 90% confidence interval for the ratio.||||1.01|0.92|
74006108|NCT01389765|147561561|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.0031|TWO_SIDED|90.0|0.5|1.5|||Wilcoxon (Mann-Whitney)|Analyzed were the median of paired differences between the 2 treatment states (fed versus fasted) and the 90% confidence interval.||||1.50|0.50|0.0031
74006109|NCT03877432|147561562|SUPERIORITY|||||||0.012|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 1T stimulation amplitude changes on bladder capacity.||||0.012
74006110|NCT03877432|147561562|SUPERIORITY|||||||0.017|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 2T stimulation amplitude changes on bladder capacity.||||0.017
74006111|NCT03877432|147561562|SUPERIORITY|||||||0.003|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 3T stimulation amplitude changes on bladder capacity.||||0.003
74006112|NCT03877432|147561562|SUPERIORITY|||||||0.004|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 4T stimulation amplitude changes on bladder capacity.||||0.004
74006113|NCT00174265|147561564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in NSA Scale total score between asenapine and olanzapine at Day 365.||||0.0148
74006114|NCT00174265|147561565|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0||||Significant level adjusted for one interim analysis was set as 0.049 two-sided.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in QLS total score between asenapine and olanzapine at Week 52.||||0.8100
74006115|NCT03040622|147561573|OTHER|||||||0.06|||||||ANOVA|||||||0.06
74006116|NCT03040622|147561574|OTHER|||||||0.009|||||||ANOVA|||||||0.009
74006117|NCT03040622|147561575|OTHER|||||||0.001|||||||ANOVA|||||||0.001
74006118|NCT04091451|147561622|NON_INFERIORITY|The non-inferiority was to be demonstrated if the upper limit (UL) of the 95% confidence interval (CI) of the ratio of the incidence of HZ recurrence between HZ/su group and Placebo group was below (\<) 5.|Incidence Rate Ratio (IRR)|0.0|||||TWO_SIDED|95.0|0.0|0.46|||Poisson||IRR = incidence rate of HZ recurrence in HZ/su group divided by the incidence rate of HZ recurrence in Placebo group. Poisson method was used to adjust for differences in follow-up time across individuals.|To demonstrate the non-inferiority of HZ/su vaccine compared to placebo in terms of incidence of HZ recurrence from 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months).||0.46|0.00|
74006119|NCT01117454|147561671|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank with continuity correction||||||0.008
74006120|NCT01681628|147561676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.0|<|0.001|TWO_SIDED|95.0|16.1|24.0||This was an a priori threshold.|t-test, 2 sided|||Means and differences were calculated for both groups before (time 1) and after treatment (or no treatment) (time 2). Also, the differences in mean scores from time 1 to 2 were compared between the two groups, the primary outcome. The numbers in the groups were considered adequate based on previous similar studies. The null hypothesis was that there would be no difference in any mean change in scores from time 1 to 2, between both groups.||24.0|16.1|<0.001
74006121|NCT01681628|147561676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.4|STANDARD_DEVIATION|14.7|<|0.001|TWO_SIDED|95.0|29.1|34.7|||t-test, 2 sided|||Change in PCL-C scores from before to after treatment.||34.7|29.1|<0.001
74006122|NCT01681628|147561676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.4|STANDARD_DEVIATION|14.2|<|0.001|TWO_SIDED|95.0|11.4|17.1|||t-test, 2 sided|||Changes in PCL-C scores for control group after no treatment.||17.1|11.4|<0.001
74006123|NCT01681628|147561676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|STANDARD_DEVIATION|13.5|<|0.001|TWO_SIDED|95.0|17.1|22.5|||t-test, 2 sided|Degrees of freedom 94||Change in control group PCL-C scores after treatment, that is from time 2 to time 3.||22.5|17.1|<0.001
74006124|NCT01681628|147561677|SUPERIORITY_OR_OTHER||percentage of participants|65.7|||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-squared test of any change in PCL-C from time 1 to time 2.||||<0.001
74006125|NCT01681628|147561677|SUPERIORITY_OR_OTHER||% of participants with PCL score > 50|41.0|||<|0.001|TWO_SIDED||||||Chi-squared|||Comparison of the percentage with diagnostic scores in the wait list group after no treatment at times 1 and 2.||||<0.001
74006126|NCT01681628|147561677|SUPERIORITY_OR_OTHER||Percentage|39.9|||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
74006127|NCT01681628|147561678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8|||<|0.001|TWO_SIDED|95.0|15.2|20.5|||t-test, 2 sided|||Both the original treatment and control groups were combined as both groups had been treated at a similar time before the nineteen month assessment. The null hypothesis was that there had been no change in the PCL-C scores at nineteen months compared to one week following treatment.||20.5|15.2|<0.001
74006128|NCT01346488|147561713|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
74006129|NCT01346488|147561713|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
74006130|NCT01346488|147561713|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
74006131|NCT01346488|147561713|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
74006132|NCT01346488|147561713|SUPERIORITY_OR_OTHER|||||||1||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||1.0000
74006133|NCT01346488|147561713|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
74006134|NCT01346488|147561714|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
74006135|NCT01346488|147561714|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
74006136|NCT01346488|147561714|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
74006137|NCT01346488|147561714|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
74006138|NCT01346488|147561714|SUPERIORITY_OR_OTHER|||||||0.0054||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||0.0054
74006139|NCT01346488|147561714|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
74006140|NCT01346488|147561715|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||<0.0001
74006141|NCT01346488|147561715|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||<0.0001
74006142|NCT01346488|147561715|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
74006143|NCT01346488|147561715|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||<0.0001
74006144|NCT01346488|147561715|SUPERIORITY_OR_OTHER|||||||0.0592||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||0.0592
74038590|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-64.49|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-70.84|-58.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-58.14|-70.84|<0.001
74038591|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.31|STANDARD_ERROR_OF_MEAN|4.42|<|0.001|TWO_SIDED|95.0|-77.04|-59.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-59.57|-77.04|<0.001
74039863|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.3906|TWO_SIDED|95.0|-0.48|0.19|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.48|0.3906
74006145|NCT01346488|147561715|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
74006146|NCT01346488|147561716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
74006147|NCT01346488|147561716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||<0.0001
74006148|NCT01346488|147561716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||<0.0001
74006149|NCT01346488|147561716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||<0.0001
74006150|NCT01346488|147561716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
74006151|NCT01346488|147561716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
74006152|NCT01346488|147561717|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
74006153|NCT01346488|147561717|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
74006154|NCT01346488|147561717|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
74006155|NCT01346488|147561717|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
74006156|NCT01346488|147561717|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
74006157|NCT01346488|147561717|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
74006158|NCT01346488|147561718|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||<0.0001
74006159|NCT01346488|147561718|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
74006160|NCT01346488|147561718|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
74006161|NCT01346488|147561718|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
74006162|NCT01346488|147561718|SUPERIORITY_OR_OTHER||||||=|0.0005||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||= 0.0005
74006163|NCT01346488|147561718|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
74006164|NCT01346488|147561719|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
74006165|NCT01346488|147561719|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
74006166|NCT01346488|147561719|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
74006167|NCT01346488|147561719|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
74006168|NCT01346488|147561719|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
74006169|NCT01346488|147561719|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
74006170|NCT01346488|147561720|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
73878373|NCT04244253|147296124|SUPERIORITY||Difference of score|-1.1||||0.288|TWO_SIDED|95.0|-3.3|1.0|||Mixed-model repeated measures|MMRM included treatment, visit, treatment-by-visit interaction, baseline, and baseline-by-visit interaction using an unstructured covariance matrix.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||1.0|-3.3|0.288
73878374|NCT04244253|147296125|OTHER||Difference in response rate|5.6||||0.329|TWO_SIDED|95.0|-5.6|16.8|||χ2 test|The MADRS response rate in the OPC-64005 20-mg group and the placebo group were compared using the χ2 test in the LOCF dataset.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||16.8|-5.6|0.329
73878375|NCT04244253|147296126|OTHER||Difference of Proportion|1.5||||0.731|TWO_SIDED|95.0|-7.2|10.3|||χ2 test|The MADRS remission rate in the OPC-64005 20-mg group and placebo group were compared using the χ2 test in the LOCF dataset.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||10.3|-7.2|0.731
74006171|NCT01346488|147561720|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
73957241|NCT04771273|147450412|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-57.02|||<|0.0001|TWO_SIDED|95.0|-67.66|-46.39||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg-Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-46.39|-67.66|<.0001
74006172|NCT01346488|147561720|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
74006173|NCT01346488|147561720|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
74006174|NCT01346488|147561720|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
74006175|NCT01346488|147561720|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
74006176|NCT01346488|147561721|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
74006177|NCT01346488|147561721|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
73878376|NCT04663321|147296127|SUPERIORITY|Difference in LS Means|LS Mean Difference|3.3||||0.168|TWO_SIDED|95.0|-1.4|8.0|||ANCOVA|||||8.0|-1.4|0.168
73878377|NCT04663321|147296127|SUPERIORITY|Difference in LS Means|LS Mean Difference|-1.1||||0.697|TWO_SIDED|95.0|-6.9|4.7|||ANCOVA|||||4.7|-6.9|0.697
73878378|NCT04663321|147296128|SUPERIORITY|Difference in LS Means|LS Mean Difference|2.9||||0.124|TWO_SIDED|95.0|-0.8|6.6|||ANCOVA|||||6.6|-0.8|0.124
73878379|NCT04663321|147296128|SUPERIORITY|Difference in LS Means|LS Mean Difference|1.9||||0.417|TWO_SIDED|95.0|-2.7|6.4|||ANCOVA|||||6.4|-2.7|0.417
73878380|NCT04663321|147296131|SUPERIORITY|Difference in LS Means|LS Mean Difference|2.0||||0.187|TWO_SIDED|95.0|-1.0|5.1|||ANCOVA|||||5.1|-1.0|0.187
73878381|NCT04663321|147296131|SUPERIORITY|Difference in LS Means|LS Mean Difference|-0.6||||0.738|TWO_SIDED|95.0|-4.3|3.1|||ANCOVA|||||3.1|-4.3|0.738
73878382|NCT04663321|147296132|SUPERIORITY|Difference in LS means|LS Mean Difference|1.7||||0.182|TWO_SIDED|95.0|-0.8|4.3|||ANCOVA|||||4.3|-0.8|0.182
73878383|NCT04663321|147296133|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.1||||0.63|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||||0.7|-0.4|0.630
73878384|NCT04663321|147296133|SUPERIORITY|Difference in LS Means|LS Mean Difference|-0.2||||0.549|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.549
73878385|NCT04663321|147296134|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.4||||0.062|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||||0.8|-0.0|0.062
73878386|NCT04663321|147296134|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.0||||0.878|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||||0.5|-0.5|0.878
74006178|NCT01346488|147561721|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
74006179|NCT01346488|147561721|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
74006180|NCT01346488|147561721|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
74006181|NCT01346488|147561721|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
74006182|NCT01346488|147561722|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
74006183|NCT01346488|147561722|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
74006184|NCT01346488|147561722|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
74006185|NCT01346488|147561722|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
74006186|NCT01346488|147561722|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
74006187|NCT01346488|147561722|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
74006188|NCT01346488|147561723|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
74006189|NCT01346488|147561723|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
74006190|NCT01346488|147561723|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
74006191|NCT01346488|147561723|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
74006192|NCT01346488|147561723|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
74006193|NCT01346488|147561723|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
74006194|NCT01346488|147561724|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
74006195|NCT01346488|147561724|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
74038592|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.98|STANDARD_ERROR_OF_MEAN|5.23|<|0.001|TWO_SIDED|95.0|-65.31|-44.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.65|-65.31|<0.001
74006196|NCT01346488|147561724|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
74006197|NCT01346488|147561724|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
74006198|NCT01346488|147561724|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
74006199|NCT01346488|147561724|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
74006200|NCT01346488|147561725|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
74006201|NCT01346488|147561725|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
74006202|NCT01346488|147561725|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
74006203|NCT01346488|147561725|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
74006204|NCT01346488|147561725|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
74006205|NCT01346488|147561725|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
74006206|NCT01008696|147561728|SUPERIORITY_OR_OTHER|||||||0.8849||||||Homozygous extensive metabolizer|Chi-squared|||||||0.8849
74091059|NCT01698775|147735980|SUPERIORITY_OR_OTHER||Difference in percentages|-3.8|||||TWO_SIDED|95.0|-16.3|8.8|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||8.8|-16.3|
74006207|NCT01008696|147561728|SUPERIORITY_OR_OTHER|||||||0.865||||||Heterozygous extensive metabolizer|Chi-squared|||||||0.8650
74006208|NCT01008696|147561728|SUPERIORITY_OR_OTHER|||||||0.266||||||Poor metabolizer|Chi-squared|||||||0.2660
74006209|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.7734||||||Change at Day 57: Heartburn|Wilcoxon rank-sum test|||||||0.7734
74006210|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.6414||||||Change at Day 57: Regurgitation|Wilcoxon rank-sum test|||||||0.6414
74006211|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.7809||||||Change at Day 57: Globus sensation|Wilcoxon rank-sum test|||||||0.7809
74006212|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.8294||||||Change at Day 57: Chronic cough|Wilcoxon rank-sum test|||||||0.8294
74006213|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.9874||||||Change at Day 57: Epigastric pain|Wilcoxon rank-sum test|||||||0.9874
74006214|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.2776||||||Change at Day 57: Non cardiac chest pain|Wilcoxon rank-sum test|||||||0.2776
74006215|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.6295||||||Change at Day 57: Hoarseness|Wilcoxon rank-sum test|||||||0.6295
74006216|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.5335||||||Change at Day 57: Dysphagia|Wilcoxon rank-sum test|||||||0.5335
74006217|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.8068||||||Change at Day 57: Abdominal distension|Wilcoxon rank-sum test|||||||0.8068
74006218|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.568||||||Change at Day 57: Bloating|Wilcoxon rank-sum test|||||||0.5680
74006219|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.5913||||||Change at Day 57: Post-prandial discomfort|Wilcoxon rank-sum test|||||||0.5913
74006220|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.5566||||||Change at Day 57: Early satiety|Wilcoxon rank-sum test|||||||0.5566
74006221|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.7047||||||Change at Day 57: Nausea|Wilcoxon rank-sum test|||||||0.7047
74006222|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.3654||||||Change at Day 57: Vomitting|Wilcoxon rank-sum test|||||||0.3654
74006223|NCT01008696|147561729|SUPERIORITY_OR_OTHER|||||||0.531||||||Change at Day 57: Belching|Wilcoxon rank-sum test|||||||0.5310
74006224|NCT01008696|147561730|SUPERIORITY_OR_OTHER|||||||0.5032|||||||Wilcoxon rank-sum test|||||||0.5032
74006225|NCT01621230|147561755|OTHER|The median (first and third quartile) lengths of the second stage of labor were estimated at 28min (15, 58) in women without epidural analgesia. Assuming a one-third increase in the length of the second stage to 37min due to epidural bupivacaine, a sample size of 155 per arm (310 total) was required for 80% power to detect such a difference using a two-sided Wilcoxon rank sum test.||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
74006226|NCT01621230|147561758|OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||.55
74006227|NCT01621230|147561759|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||.57
74006228|NCT03801902|147561787|OTHER||||||||||||||||||"If 0-1 of initial 6 evaluable patients on an arm have a safety event, then the regimen will be deemed safe and that arm will continue to the second part of the study to enroll 6 additional evaluable patients. However, if 2 or more of the 6 patients develop a safety event, then that arm is considered not safe and will not continue to second part. The probability of the treatment being judged to be too toxic when the true toxicity rate is ≥ 40% is at least 77%. If the true toxicity rate is ≤ 18%, then the probability that the treatment will be deemed to be safe is at least 70%.~If fewer than 4 of the total of 12 evaluable patients on an arm experience a safety event, then the treatment will be considered tolerable. With a cohort of 12 patients, the probability of the treatment being judged to be too toxic when the true toxicity rate is ≥ 40% at least 78%. If the true toxicity rate is ≤ 18%, the probability that the treatment will be deemed to be safe is 85%."|||
74091060|NCT01698775|147735981|SUPERIORITY_OR_OTHER||Difference in percentages|1.9|||||TWO_SIDED|95.0|-2.6|7.2|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||7.2|-2.6|
74091061|NCT01698775|147735982|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-12.2|10.3|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||10.3|-12.2|
74091062|NCT01698775|147735983|SUPERIORITY_OR_OTHER||Difference in percentage|2.8|||||TWO_SIDED|95.0|-3.6|9.8||||||||9.8|-3.6|
74006229|NCT02993523|147561796|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.465|0.723||Stratified log-rank test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).|Log Rank||HR from Cox proportional hazards model stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).|||0.723|0.465|<0.001
74006230|NCT02993523|147561797|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).||||||<0.001
74006231|NCT00809523|147561888|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||Data were analyzed at the follow up timepoint (4 weeks) to test for differences between the experimental groups.||||0.007
74006232|NCT00809523|147561889|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
74006233|NCT03829319|147561920|OTHER||Hazard Ratio (HR)|0.88||||0.07976|TWO_SIDED|95.0|0.74|1.05|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.05|0.74|0.07976
74006234|NCT03829319|147561921|OTHER||Hazard Ratio (HR)|1.05||||0.70818|TWO_SIDED|95.0|0.88|1.26|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.26|0.88|0.70818
74006235|NCT03829319|147561922|OTHER||Percent Difference|6.3||||0.08643|TWO_SIDED|95.0|-2.8|15.4|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.||Comparison based on Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50% ).||15.4|-2.8|0.08643
74006236|NCT03829319|147561926|OTHER||Difference in Least Square Means|-1.01||||0.4805|TWO_SIDED|95.0|-3.83|1.8|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||1.80|-3.83|0.4805
74006237|NCT03829319|147561927|OTHER||Difference in Least Square Means|-0.29||||0.8747|TWO_SIDED|95.0|-3.95|3.36|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||3.36|-3.95|0.8747
74006238|NCT03829319|147561928|OTHER||Difference in Least Square Means|-0.91||||0.5941|TWO_SIDED|95.0|-4.24|2.43|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (\<50% versus ≥50%)) as covariates.||2.43|-4.24|0.5941
74038593|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.56|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-76.72|-64.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.41|-76.72|<0.001
74038594|NCT01763866|147630752|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.41|STANDARD_ERROR_OF_MEAN|4.41|<|0.001|TWO_SIDED|95.0|-69.11|-51.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.72|-69.11|<0.001
74091063|NCT01698775|147735984|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.9||||0.54|TWO_SIDED|95.0|-16.5|8.7|||ANCOVA|||||8.7|-16.5|0.540
74006239|NCT03829319|147561929|OTHER||covariate|-2.16||||0.3115|TWO_SIDED|95.0|-6.36|2.03|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||2.03|-6.36|0.3115
74006240|NCT03829319|147561930|OTHER||covariate|-0.37||||0.8134|TWO_SIDED|95.0|-3.47|2.72|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||2.72|-3.47|0.8134
74006241|NCT03829319|147561931|OTHER||Hazard Ratio (HR)|1.16||||0.2133|TWO_SIDED|95.0|0.92|1.47|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.47|0.92|0.2133
74006242|NCT03829319|147561932|OTHER||Hazard Ratio (HR)|1.41||||0.0377|TWO_SIDED|95.0|1.02|1.94|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.94|1.02|0.0377
74006243|NCT03829319|147561933|OTHER||Hazard Ratio (HR)|0.87||||0.4084|TWO_SIDED|95.0|0.62|1.21|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.21|0.62|0.4084
74006244|NCT03829319|147561934|OTHER||Hazard Ratio (HR)|1.04||||0.7955|TWO_SIDED|95.0|0.79|1.36|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.36|0.79|0.7955
74038595|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.95|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-75.38|-64.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.51|-75.38|<0.001
74038596|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.82|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-69.06|-56.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-56.57|-69.06|<0.001
74038597|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.53|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-43.03|-32.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-32.03|-43.03|<0.001
74038598|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.49|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-49.7|-37.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-37.28|-49.70|<0.001
74038599|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-74.92|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-84.49|-65.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.35|-84.49|<0.001
74038600|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-74.81|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-83.0|-66.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-66.62|-83.00|<0.001
74038601|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.95|STANDARD_ERROR_OF_MEAN|4.75|<|0.001|TWO_SIDED|95.0|-54.32|-35.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.57|-54.32|<0.001
74038602|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.81|STANDARD_ERROR_OF_MEAN|4.19|<|0.001|TWO_SIDED|95.0|-52.06|-35.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.55|-52.06|<0.001
74038603|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.88|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-72.67|-61.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.08|-72.67|<0.001
74091064|NCT01698775|147735987|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.4||||0.72|TWO_SIDED|95.0|-2.7|1.9|||cLDA|||||1.9|-2.7|0.720
73957242|NCT04771273|147450413|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-46.49|||<|0.0001|TWO_SIDED|95.0|-56.74|-36.25||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-36.25|-56.74|<.0001
74038604|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.58|STANDARD_ERROR_OF_MEAN|3.05|<|0.001|TWO_SIDED|95.0|-72.6|-60.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.56|-72.60|<0.001
74038605|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.66|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-73.19|-58.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-58.12|-73.19|<0.001
74038606|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.91|STANDARD_ERROR_OF_MEAN|4.27|<|0.001|TWO_SIDED|95.0|-71.37|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.46|-71.37|<0.001
74038607|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.43|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-74.86|-64.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.01|-74.86|<0.001
74038608|NCT01763866|147630753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.45|STANDARD_ERROR_OF_MEAN|4.17|<|0.001|TWO_SIDED|95.0|-76.68|-60.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.22|-76.68|<0.001
74038609|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-83.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-92.6|-74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-74.6|-92.6|<0.001
74038610|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.7|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-90.2|-69.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-69.2|-90.2|<0.001
74038611|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.4|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-53.4|-35.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.3|-53.4|<0.001
74038612|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.0|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-65.4|-44.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.6|-65.4|<0.001
74038613|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.9|STANDARD_ERROR_OF_MEAN|6.1|<|0.001|TWO_SIDED|95.0|-81.9|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.8|-81.9|<0.001
74038614|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-74.5|-56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.7|-74.5|<0.001
74038615|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.8|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-57.7|-33.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.9|-57.7|<0.001
74091065|NCT00359788|147735989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|||<|0.0001|TWO_SIDED|95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.157|0.055|<0.0001
74006245|NCT03829319|147561936|OTHER||Hazard Ratio (HR)|1.04||||0.7191|TWO_SIDED|95.0|0.84|1.28|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.28|0.84|0.7191
74006246|NCT04498832|147561937|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was greater than (\>) 1 between groups for each of the comparisons.|GMT ratio|2.81|||||TWO_SIDED|95.0|2.46|3.2|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|A/H1N1||3.20|2.46|
74006247|NCT04498832|147561937|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|2.25|||||TWO_SIDED|95.0|2.03|2.5|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|A/H3N2-like||2.50|2.03|
74006248|NCT04498832|147561937|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|2.55|||||TWO_SIDED|95.0|2.31|2.81|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|B/Victoria-like||2.81|2.31|
74006249|NCT04498832|147561937|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|3.12|||||TWO_SIDED|95.0|2.85|3.42|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|B/Yamagata||3.42|2.85|
74006250|NCT04498832|147561938|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|29.7|||||TWO_SIDED|95.0|25.7|33.5|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|A/H1N1||33.5|25.7|
74006251|NCT04498832|147561938|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|28.1|||||TWO_SIDED|95.0|24.0|32.0|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|A/H3N2-like||32.0|24.0|
74038616|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.8|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-47.8|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.9|-47.8|<0.001
74038617|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.4|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-83.9|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.0|-83.9|<0.001
74038618|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.9|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-88.0|-67.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.8|-88.0|<0.001
74006252|NCT04498832|147561938|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|31.4|||||TWO_SIDED|95.0|27.4|35.2|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|B/Victoria-like||35.2|27.4|
74006253|NCT04498832|147561938|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|35.4|||||TWO_SIDED|95.0|31.4|39.3|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|B/Yamagata||39.3|31.4|
74038619|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.8|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-63.1|-48.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.4|-63.1|<0.001
74038620|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.6|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-60.6|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.6|-60.6|<0.001
74038621|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-78.1|STANDARD_ERROR_OF_MEAN|4.1|<|0.001|TWO_SIDED|95.0|-86.2|-70.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-70.0|-86.2|<0.001
74038622|NCT01763866|147630754|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-80.1|STANDARD_ERROR_OF_MEAN|5.8|<|0.001|TWO_SIDED|95.0|-91.7|-68.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-68.6|-91.7|<0.001
74038623|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-85.5|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-95.2|-75.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-75.9|-95.2|<0.001
74006254|NCT03049735|147561957|SUPERIORITY||Treatment difference|54.54|||<|0.0001|TWO_SIDED|95.0|44.3|64.78||P-value was stratified by baseline MBL volume (\< 225 mL or ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix + E2/NETA minus placebo.|The primary efficacy analysis was the comparison of the relugolix + E2/NETA group with the placebo group with respect to responder rate.||64.78|44.3|<0.0001
74006255|NCT03049735|147561958|SUPERIORITY||Treatment difference|46.83|||<|0.0001|TWO_SIDED|95.0|37.31|56.35||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference was relugolix plus E2/NETA minus placebo. 95% confidence interval (CI) for difference is based on the normal approximation.|||56.35|37.31|<0.0001
74006256|NCT03049735|147561959|SUPERIORITY||Treatment difference|-61.1|STANDARD_ERROR_OF_MEAN|6.32|<|0.0001|TWO_SIDED|95.0|-73.5|-48.6||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|Assessed at a 2-sided α = 0.05 significance. Treatment difference is relugolix plus E2/NETA minus placebo.||||-48.6|-73.5|<0.0001
74006257|NCT03049735|147561960|SUPERIORITY||Treatment difference|28.26|||=|0.0377|TWO_SIDED|95.0|3.68|52.84||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||52.84|3.68|= 0.0377
74006258|NCT03049735|147561961|SUPERIORITY||Treatment difference|33.0|||<|0.0001|TWO_SIDED|95.0|18.36|47.56||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||47.56|18.36|<0.0001
74006259|NCT03049735|147561962|SUPERIORITY||Treatment difference|-12.1|STANDARD_ERROR_OF_MEAN|7.19||0.0921|TWO_SIDED|95.0|-26.3|2.0||Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.|ANCOVA|||||2|-26.3|0.0921
74006260|NCT03049735|147561963|SUPERIORITY||Treatment difference|-15.1|STANDARD_ERROR_OF_MEAN|3.98||0.0002|TWO_SIDED|95.0|-23.0|-7.3||Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.|ANCOVA|||||-7.3|-23|0.0002
74006261|NCT03049735|147561964|SUPERIORITY||Treatment difference|-28.9|STANDARD_ERROR_OF_MEAN|3.75|<|0.0001|TWO_SIDED|95.0|-36.3|-21.5||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|Assessed at a 2-sided α = 0.05 significance level. LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||-21.5|-36.3|<0.0001
74006262|NCT03049735|147561967|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74006263|NCT03049735|147561972|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.|Log Rank|||||||<0.0001
74006264|NCT03049735|147561973|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
74006265|NCT03049735|147561974|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||<0.0001
74006266|NCT03049735|147561975|SUPERIORITY||||||<|0.0001||||||P-value was based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.|Log Rank|||||||<0.0001
74006267|NCT03049735|147561976|SUPERIORITY|||||||0.0377||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||0.0377
74006268|NCT03049735|147561977|SUPERIORITY|||||||0.0117||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||0.0117
74006269|NCT03049735|147561978|SUPERIORITY|||||||0.0084||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World). Lower limit of normal is Hgb \< 11.6 g/dL.|Cochran-Mantel-Haenszel|||||||0.0084
74006270|NCT03049735|147561979|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
74006271|NCT03049735|147561980|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
74006272|NCT03049735|147561981|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
74006273|NCT03049735|147561982|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
74006274|NCT03049735|147561983|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between Relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
74006275|NCT03049735|147561984|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
74006276|NCT03049735|147561985|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
74006277|NCT03049735|147561986|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
74091066|NCT00359788|147735990|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.05 liters|Mean Difference (Final Values)|0.02||||0.0042||95.0|-0.032|0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.072|-0.032|0.0042
74006278|NCT03049735|147561987|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
74006279|NCT03049735|147561989|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
74006280|NCT03049735|147561996|SUPERIORITY|||||||0.0002||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||0.0002
74006281|NCT01474863|147562034|SUPERIORITY|||||||0.86|||||||ANOVA|||||||0.86
74006282|NCT03231943|147562091|OTHER||Power model|0.9476|||||TWO_SIDED|90.0|0.8982|0.9971|||||The statistical model (power model) is based on the PK parameters (AUC0-inf) from all active doses in Part 1|||0.9971|0.8982|
74006283|NCT03231943|147562092|OTHER||Power model|0.928|||||TWO_SIDED|90.0|0.8877|0.9683|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 1|||0.9683|0.8877|
74006284|NCT03231943|147562093|OTHER||Power Model|0.9352|||||TWO_SIDED|90.0|0.897|0.9734|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 1|||0.9734|0.8970|
74006285|NCT03231943|147562094|OTHER||Power model|0.7968|||||TWO_SIDED|90.0|0.6424|0.9512|||||The statistical model (power model) is based on the PK parameters (AUC0-tau) from all active doses in Part 1|||0.9512|0.6424|
74006286|NCT03231943|147562095|OTHER||Power model|0.789|||||TWO_SIDED|90.0|0.6149|0.9631|||||The statistical model (power model) is based on the PK parameters (Ctrough) from all active doses in Part 2|||0.9631|0.6149|
74006287|NCT03231943|147562096|OTHER||Power model|0.7955|||||TWO_SIDED|90.0|0.6562|0.9349|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2|||0.9349|0.6562|
74006288|NCT03231943|147562101|OTHER||Power model|0.737|||||TWO_SIDED|90.0|0.5649|0.9091|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2|||0.9091|0.5649|
74091067|NCT00359788|147735991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.193|0.098|<0.0001
74006289|NCT03231943|147562102|OTHER||Power model|0.7397|||||TWO_SIDED|90.0|0.5576|0.9218|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 2|||0.9218|0.5576|
74006290|NCT02087748|147562195|SUPERIORITY_OR_OTHER|||||||0.0324|||||||t-test, 2 sided|||||||0.0324
74006291|NCT02087748|147562196|SUPERIORITY_OR_OTHER|||||||0.3688|||||||t-test, 2 sided|||||||0.3688
74006292|NCT02087748|147562197|SUPERIORITY_OR_OTHER|||||||0.0275|||||||t-test, 2 sided|||||||0.0275
74006293|NCT03078907|147562200|OTHER||Least Square (LS) mean|13.79|STANDARD_ERROR_OF_MEAN|13.695|||TWO_SIDED|95.0|13.366|40.944|||ANCOVA|||Daily time spent in non-sedentary activity (minutes), Freedson '98||40.944|13.366|
74006294|NCT03078907|147562200|OTHER||LS means|2.31|STANDARD_ERROR_OF_MEAN|6.601|||TWO_SIDED|95.0|-10.782|15.396|||ANCOVA|||Daily time spent in MVPA (minutes), Freedson '98||15.396|-10.782|
74006295|NCT03078907|147562200|OTHER||LS mean|17.81|STANDARD_ERROR_OF_MEAN|12.008|||TWO_SIDED|95.0|-6.003|41.619|||ANCOVA|||Daily time spent in non-sedentary activity (minutes), Koster '16||41.619|-6.003|
74006296|NCT03078907|147562201|OTHER||LS mean|0.67|STANDARD_ERROR_OF_MEAN|1.204|||TWO_SIDED|95.0|-1.713|3.06|||ANCOVA|||Percentage of daily time spent in non-sedentary activity (%), Freedson '98||3.060|-1.713|
74006297|NCT03078907|147562201|OTHER||LS mean|-0.05|STANDARD_ERROR_OF_MEAN|0.658|||TWO_SIDED|95.0|-1.351|1.258|||ANCOVA|||Percentage of daily time spent in MVPA (%), Freedson '98||1.258|-1.351|
74006298|NCT03078907|147562201|OTHER||LS mean|1.26|STANDARD_ERROR_OF_MEAN|1.191|||TWO_SIDED|95.0|-1.104|3.618|||ANCOVA|||Percentage of daily time spent in non-sedentary activity (%), Koster '16||3.618|-1.104|
74006299|NCT03078907|147562202|OTHER||LS mean|20.66|STANDARD_ERROR_OF_MEAN|63.695|||TWO_SIDED|95.0|-105.632|146.958|||ANCOVA|||Volume of total daily activities (counts / minute)||146.958|-105.632|
74006300|NCT03078907|147562202|OTHER||LS means|27.52|STANDARD_ERROR_OF_MEAN|65.291|||TWO_SIDED|95.0|-101.945|156.976|||ANCOVA|||Volume of non-sedentary activity (counts/minute), Koster '16||156.976|-101.945|
74006301|NCT03078907|147562203|OTHER||LS means|58409.0|STANDARD_ERROR_OF_MEAN|64985.0|||TWO_SIDED|95.0|-70444.0|187263.0|||ANCOVA|||||187263|-70444|
74091068|NCT00359788|147735992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||<|0.0001||95.0|-0.114|-0.046|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.046|-0.114|<0.0001
74091069|NCT00359788|147735993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054||||0.0447||95.0|0.001|0.106|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.106|0.001|0.0447
74006302|NCT03078907|147562204|OTHER||LS means|201.59|STANDARD_ERROR_OF_MEAN|224.212|||TWO_SIDED|95.0|-242.977|646.163|||ANCOVA|||||646.163|-242.977|
74006303|NCT03078907|147562205|OTHER||LS means|0.07|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|95.0|-0.366|0.51|||ANCOVA|||||0.510|-0.366|
74006304|NCT03808688|147562235|OTHER|Descriptive statistics included the number of subjects/eyes(n), mean, SD, median, minimum, and maximum for continuous variables, and frequency and percentages for categorical variables.||||||||||||||||Cohorts assessed versus baseline treatment|All efficacy data were summarized at each timepoint using appropriate descriptive statistics for the overall populations as well as separately for monotherapy and concomitant therapy groups.|||
74006305|NCT02960113|147562246|OTHER|||||||0.98||||||Bonferroni-adjusted P-value, calculated as two times the nominal p-value because there are two primary outcomes|Chi-squared|d.f.=2||Null hypothesis: Percent experiencing nausea equal between groups||||0.98
74006306|NCT02960113|147562247|OTHER|||||||0.9||||||Bonferroni-adjusted P-value, calculated as two times the nominal p-value because there are two primary outcomes|Chi-squared|d.f.=2||Null hypothesis: Percent experiencing vomiting equal across groups||||0.90
74006307|NCT02960113|147562248|OTHER|Null hypothesis: Mean scores equal across treatment groups||||||0.026|||||||ANOVA|||||||0.026
74006308|NCT02960113|147562249|OTHER|Null hypothesis: means equal across treatment groups||||||0.91|||||||ANOVA|||||||0.91
74006309|NCT02960113|147562250|OTHER|||||||0.8|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.80
74006310|NCT02960113|147562251|OTHER|||||||0.82|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.82
74006311|NCT02960113|147562252|OTHER|||||||0.93|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.93
74006312|NCT02960113|147562253|OTHER|Null hypothesis: percent of vomiting equal across treatment groups||||||0.55|||||||Chi-squared|d.f.=2||||||0.55
74006313|NCT02960113|147562254|OTHER|||||||0.71|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.71
74006314|NCT02960113|147562255|OTHER|||||||0.55|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.55
74006315|NCT02960113|147562256|OTHER|||||||0.2|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.20
74006316|NCT03434353|147562257|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-30.4|26.4|||||The percentage difference (Group 1 - Group 2) \& corresponding 2-sided 95% confidence interval (CI) were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline hepatitis B e antigen (HBeAg) status (positive,negative).|||26.4|-30.4|
74006317|NCT03434353|147562257|OTHER||Percentage Difference|-24.7|||||TWO_SIDED|95.0|-49.2|-0.2|||||The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||-0.2|-49.2|
74006318|NCT03434353|147562257|OTHER||Percentage Difference|-17.8|||||TWO_SIDED|95.0|-43.7|8.2|||||The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||8.2|-43.7|
74006319|NCT03434353|147562259|OTHER||Percentage Difference|-16.6|||||TWO_SIDED|95.0|-37.7|4.4|||||The percentage difference (Group 1 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.4|-37.7|
74006320|NCT03434353|147562259|OTHER||Percentage Difference|-16.9|||||TWO_SIDED|95.0|-38.1|4.3|||||The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.3|-38.1|
74091070|NCT00359788|147735994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.131|||<|0.0001||95.0|-0.171|-0.092|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.092|-0.171|<0.0001
74091071|NCT00359788|147735995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.152|||<|0.0001||95.0|-0.19|-0.113|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.113|-0.19|<0.0001
74091072|NCT00359788|147735996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|||<|0.0001||95.0|-0.175|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.091|-0.175|<0.0001
74006321|NCT03434353|147562259|OTHER||Percentage Difference|-16.7|||||TWO_SIDED|95.0|-37.9|4.4|||||The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.4|-37.9|
74038624|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|5.5|<|0.001|TWO_SIDED|95.0|-86.8|-64.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-64.9|-86.8|<0.001
74038625|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-56.6|-37.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.1|-56.6|<0.001
74038626|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-51.7|STANDARD_ERROR_OF_MEAN|5.5|<|0.001|TWO_SIDED|95.0|-62.6|-40.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.9|-62.6|<0.001
74038627|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.7|STANDARD_ERROR_OF_MEAN|6.4|<|0.001|TWO_SIDED|95.0|-84.4|-59.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-59.0|-84.4|<0.001
74038628|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-71.6|-52.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.0|-71.6|<0.001
74038629|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.0|STANDARD_ERROR_OF_MEAN|6.3|<|0.001|TWO_SIDED|95.0|-61.5|-36.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.6|-61.5|<0.001
74038630|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.3|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-45.2|-25.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.5|-45.2|<0.001
74091073|NCT00359788|147735997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.283|0.067|0.0015
74091074|NCT00359788|147735998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.835||95.0|-0.092|0.114|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.114|-0.092|0.835
74091075|NCT00359788|147735999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.379|0.178|<0.0001
74091076|NCT00359788|147736000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.157|||<|0.0001||95.0|-0.236|-0.078|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.078|-0.236|<0.0001
74006322|NCT00148954|147562306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.003|TWO_SIDED|95.0|1.11|1.62|||Regression, Cox|||||1.62|1.11|0.003
74038631|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.1|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-86.2|-67.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.9|-86.2|<0.001
74091077|NCT00359788|147736001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.4386||95.0|-0.059|0.137|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.137|-0.059|0.4386
74038632|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-86.3|-65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-65.3|-86.3|<0.001
74038633|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.2|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-65.1|-49.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.4|-65.1|<0.001
74091078|NCT00359788|147736002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.282||||0.0001||95.0|-0.374|-0.191|||ANCOVA|||||-0.191|-0.374|0.0001
74091079|NCT00359788|147736003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.361|||<|0.0001||95.0|-0.449|-0.274|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.274|-0.449|<0.0001
74006323|NCT02021292|147562345|SUPERIORITY||ratio of geometric means|0.84||||0.041|TWO_SIDED|95.0|0.7|0.99|||ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The null hypothesis (change of PVR at rest in Week 16 in percent of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed % of baseline PVR at rest at Week 16.||0.99|0.70|0.0410
74038634|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.6|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|-55.9|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.4|-55.9|<0.001
74038635|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.0|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-87.5|-70.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-70.4|-87.5|<0.001
74038636|NCT01763866|147630755|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.9|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-83.8|-60.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-60.0|-83.8|<0.001
74038637|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.28|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-65.29|-55.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.27|-65.29|<0.001
74038638|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.37|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-63.23|-51.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.51|-63.23|<0.001
74038639|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.77|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-37.84|-27.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-27.70|-37.84|<0.001
74038640|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.53|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|-45.34|-33.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.71|-45.34|<0.001
74038641|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.17|STANDARD_ERROR_OF_MEAN|4.37|<|0.001|TWO_SIDED|95.0|-73.78|-56.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.56|-73.78|<0.001
74038642|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-64.76|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-72.32|-57.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.19|-72.32|<0.001
74038643|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.25|STANDARD_ERROR_OF_MEAN|4.28|<|0.001|TWO_SIDED|95.0|-46.68|-29.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.81|-46.68|<0.001
74091080|NCT00359788|147736004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.286|||<|0.0001||95.0|-0.375|-0.196|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.196|-0.375|<0.0001
74091081|NCT00359788|147736005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.175|||<|0.0001||95.0|-0.207|-0.142|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.142|-0.207|<0.0001
74038644|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.52|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-45.15|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.90|-45.15|<0.001
74038645|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.61|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-64.73|-54.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.48|-64.73|<0.001
74038646|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.2|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-64.8|-53.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.60|-64.80|<0.001
74091082|NCT00359788|147736006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.168|||<|0.0001||95.0|-0.205|-0.131|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.131|-0.205|<0.0001
74091083|NCT00359788|147736007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182|||<|0.0001||95.0|-0.221|-0.143|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.143|-0.221|<0.0001
74091084|NCT00359788|147736008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.136|||<|0.0001||95.0|-0.175|-0.097|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.097|-0.175|<0.0001
74091085|NCT00359788|147736009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||<|0.0001||95.0|-0.125|-0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.044|-0.125|<0.0001
74091086|NCT00359788|147736010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035||||0.0997||95.0|-0.076|0.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.007|-0.076|0.0997
74091087|NCT00359788|147736011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.101||95.0|-0.007|0.08|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.08|-0.007|0.101
74038647|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.27|STANDARD_ERROR_OF_MEAN|3.2|<|0.001|TWO_SIDED|95.0|-64.6|-51.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.94|-64.60|<0.001
74038648|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.31|STANDARD_ERROR_OF_MEAN|3.53|<|0.001|TWO_SIDED|95.0|-64.29|-50.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.32|-64.29|<0.001
74038649|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.06|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-65.18|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.94|-65.18|<0.001
74038650|NCT01763866|147630756|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.82|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-70.22|-55.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-55.42|-70.22|<0.001
74038651|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.64|STANDARD_ERROR_OF_MEAN|2.84|<|0.001|TWO_SIDED|95.0|-67.25|-56.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.03|-67.25|<0.001
74038652|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.93|STANDARD_ERROR_OF_MEAN|3.28|<|0.001|TWO_SIDED|95.0|-61.4|-48.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.46|-61.40|<0.001
74038653|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.11|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-40.79|-29.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.44|-40.79|<0.001
74091088|NCT00359788|147736012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.193|0.098|<0.0001
74006324|NCT02021292|147562346|SUPERIORITY||least squares (LS) mean difference|34.04||||0.0326|TWO_SIDED|95.0|2.9|65.2||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is that the mean change from baseline in 6MWD at Week 24 is the same in the placebo and the macitentan group. Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model.||65.2|2.9|0.0326
74006325|NCT02021292|147562347|SUPERIORITY||least squares (LS) mean difference|-0.39||||0.3492|TWO_SIDED|95.0|-1.21|0.43||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is that the mean change from baseline is the same in the placebo and the macitentan group. Statistical model is Analysis of Covariance including Borg dyspnea index at baseline as a covariate, with Treatment as factor in the model.||0.43|-1.21|0.3492
74006326|NCT02021292|147562348|SUPERIORITY||Odds Ratio (OR)|0.212||||0.0962|TWO_SIDED|95.0|0.001|1.464||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is the odds of worsening are the same in the placebo and the macitentan group. Logistic regression is used for Treatment Group vs. Placebo comparison to generate odds ratio, confidence levels, and p-values with treatment and WHO functional class at baseline as factors in the model.||1.464|0.001|0.0962
74006327|NCT02021292|147562349|SUPERIORITY||Model-adjusted geometric mean ratio|0.81||||0.0098|TWO_SIDED|95.0|0.7|0.95||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The same statistical model as for the predefined analysis (ANCOVA) was applied, including 13 subjects with corrected hemodynamic values.||0.95|0.70|0.0098
74038654|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.72|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-44.15|-31.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.30|-44.15|<0.001
74038655|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.64|STANDARD_ERROR_OF_MEAN|4.69|<|0.001|TWO_SIDED|95.0|-75.88|-57.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.39|-75.88|<0.001
74091089|NCT00359788|147736013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.055||||0.0411||95.0|-0.108|-0.002|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.002|-0.108|0.0411
74091090|NCT00359788|147736014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.0354||95.0|-0.116|-0.004|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.004|-0.116|0.0354
74006328|NCT02021292|147562350|SUPERIORITY||Model-adjusted geometric mean ratio|0.79||||0.0061|TWO_SIDED|95.0|0.68|0.93||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||||0.93|0.68|0.0061
74006329|NCT02021292|147562351|SUPERIORITY||Geometric mean ratio|0.85||||0.0414|TWO_SIDED|95.0|0.73|0.99||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||||0.99|0.73|0.0414
74006330|NCT02021292|147562352|SUPERIORITY||least squares (LS) mean difference|37.19||||0.0468|TWO_SIDED|95.0|0.54|73.83||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model.||||73.83|0.54|0.0468
74006331|NCT03865940|147562358|SUPERIORITY|||||||0.374|TWO_SIDED|95.0||||P-values less than 0.05 considered significant.|Regression, Cox|Testing null hypothesis that guanfacine has no effect on time from injection to return to baseline.||||||0.374
74006332|NCT03865940|147562359|SUPERIORITY||||||<|0.001||||||P-values less than 0.05 considered significant.|Regression, Logistic|Analysis adjusted for pre-injection score and accounted for repeated measures. Effect of study drug was tested using a four degree-of-freedom test.||||||<0.001
74006333|NCT03865940|147562360|SUPERIORITY|||||||0.775|||||||Regression, Linear|The analysis adjusted for pre-injection score and accounted for repeat measures.The results of the analyses tested using a two degree-of-freedom test.||||||0.775
74038656|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.01|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-68.49|-51.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.52|-68.49|<0.001
74038657|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.51|STANDARD_ERROR_OF_MEAN|4.59|<|0.001|TWO_SIDED|95.0|-49.55|-31.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.47|-49.55|<0.001
74038658|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.79|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-41.3|-24.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.28|-41.30|<0.001
74038659|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.96|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|-65.78|-54.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.13|-65.78|<0.001
74038660|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.42|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-63.27|-51.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.57|-63.27|<0.001
74038661|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.58|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-66.95|-52.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.21|-66.95|<0.001
74091091|NCT00359788|147736015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.062||||0.041||95.0|-0.121|-0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.003|-0.121|0.041
74006334|NCT03865940|147562361|SUPERIORITY|||||||0.099|||||||Regression, Linear|The analysis adjusted for pre-injection score and accounted for repeat measures.The results of the analyses tested using a two degree-of-freedom test.||||||0.099
74006335|NCT03865940|147562362|SUPERIORITY|||||||0.907|||||||Proportional Odds Regression|The analysis was not adjusted for baseline factors.||||||0.907
74038662|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.76|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-58.26|-41.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.27|-58.26|<0.001
74038663|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.91|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-66.57|-55.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.24|-66.57|<0.001
74091092|NCT00359788|147736016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018||||0.5387||95.0|-0.076|0.04|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.04|-0.076|0.5387
74091093|NCT00359788|147736017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061||||0.0372||95.0|0.004|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.118|0.004|0.0372
74006336|NCT03865940|147562363|SUPERIORITY|||||||0.373|||||||Regression, Logistic|Adjusted for use of pain medication at baseline||||||0.373
74006337|NCT02366728|147562404|OTHER|||||||0.072|||||||Log Rank|||||||0.072
74006338|NCT02366728|147562404|OTHER|||||||0.089|||||||Log Rank|||||||0.089
74006339|NCT02366728|147562405|OTHER|||||||0.0195|||||||Wilcoxon (Mann-Whitney)|||||||0.0195
74006340|NCT02366728|147562406|OTHER|||||||0.4|||||||Log Rank|||||||0.40
74006341|NCT02366728|147562407|OTHER|||||||0.4|||||||Log Rank|||||||0.40
74006342|NCT02366728|147562408|OTHER|||||||0.16|||||||Log Rank|||||||0.16
74006343|NCT02366728|147562408|OTHER|||||||0.078|||||||Log Rank|||||||0.078
74006344|NCT02366728|147562409|OTHER|||||||0.64|||||||Log Rank|||||||0.64
74006345|NCT02366728|147562410|OTHER|||||||0.29|||||||Log Rank|||||||0.29
74091094|NCT00359788|147736018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.0001||95.0|0.066|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.177|0.066|<0.0001
74091095|NCT00359788|147736019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.108|0.216|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.216|0.108|<0.0001
74091096|NCT00359788|147736020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|||<|0.0001||95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.157|0.055|<0.0001
74091097|NCT00359788|147736021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083||||0.0023||95.0|-0.136|-0.03|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.03|-0.136|0.0023
74091098|NCT00359788|147736022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087||||0.0019||95.0|-0.142|-0.033|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.033|-0.142|0.0019
74091099|NCT00359788|147736023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083||||0.0044||95.0|-0.139|-0.026|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.026|-0.139|0.0044
74091100|NCT00359788|147736024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.1182||95.0|-0.103|0.012|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.012|-0.103|0.1182
74091101|NCT00359788|147736025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.4814||95.0|-0.037|0.078||ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|ANCOVA|||||0.078|-0.037|0.4814
74091102|NCT00359788|147736026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074||||0.008||95.0|0.019|0.129|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.129|0.019|0.008
73957243|NCT04771273|147450413|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-55.11|||<|0.0001|TWO_SIDED|95.0|-65.25|-44.98||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-44.98|-65.25|<.0001
74091103|NCT00359788|147736027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|||<|0.0001||95.0|0.082|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.19|0.082|<0.0001
74091104|NCT00359788|147736028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.0001||95.0|-0.449|-0.29|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.29|-0.449|<0.0001
74091105|NCT00359788|147736029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.356|||<|0.0001||95.0|-0.44|-0.272|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.272|-0.44|<0.0001
74091106|NCT00359788|147736030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|||<|0.0001||95.0|-0.451|-0.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.264|-0.451|<0.0001
74091107|NCT00359788|147736031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.285|||<|0.0001||95.0|-0.376|-0.194|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.194|-0.376|<0.0001
74091108|NCT00359788|147736032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.0003||95.0|-0.261|-0.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.079|-0.261|0.0003
74091109|NCT00359788|147736033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.2992||95.0|-0.143|0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.044|-0.143|0.2992
74091110|NCT00359788|147736034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081||||0.0984||95.0|-0.015|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.177|-0.015|0.0984
74091111|NCT00359788|147736035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.379|0.178|<0.0001
74091112|NCT00359788|147736036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.189||||0.0004||95.0|-0.293|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.086|-0.293|0.0004
74091113|NCT00359788|147736037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.204||||0.0003||95.0|-0.314|-0.095|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.095|-0.314|0.0003
74091114|NCT00359788|147736038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1832||||0.012||95.0|-0.293|-0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.072|-0.293|0.012
74091115|NCT00359788|147736039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.044||95.0|-0.219|0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.003|-0.219|0.044
74091116|NCT00359788|147736040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.3634||95.0|-0.058|0.158|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.158|-0.058|0.3634
74091117|NCT00359788|147736041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163||||0.0032||95.0|0.055|0.27|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.27|0.055|0.0032
74091118|NCT00359788|147736042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|||<|0.0001||95.0|0.173|0.378|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.378|0.173|<0.0001
74091119|NCT00359788|147736043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.283|0.067|0.0015
74091120|NCT00359788|147736044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193||||0.0002||95.0|-0.296|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.091|-0.296|0.0002
74091121|NCT00359788|147736045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215|||<|0.0001||95.0|-0.323|-0.108|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.108|-0.323|<0.0001
74038664|NCT01763866|147630757|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.63|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-64.63|-48.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-48.62|-64.63|<0.001
74006346|NCT00992511|147562413|NON_INFERIORITY|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.06|||||TWO_SIDED|95.0|0.77|1.46||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition \[HI\] antibody geometric mean titres \[GMTs\]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.||1.46|0.77|
74006347|NCT00992511|147562413|NON_INFERIORITY|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.17|||||TWO_SIDED|95.0|0.86|1.61||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition \[HI\] antibody geometric mean titres \[GMTs\]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.||1.61|0.86|
74038665|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.49|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|-63.1|-53.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.89|-63.10|<0.001
74038666|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.25|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-57.49|-47.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-47.01|-57.49|<0.001
74038667|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.66|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-38.33|-28.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.98|-38.33|<0.001
74038668|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.01|STANDARD_ERROR_OF_MEAN|2.67|<|0.001|TWO_SIDED|95.0|-45.27|-34.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.74|-45.27|<0.001
74038669|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.34|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-66.61|-52.07||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.07|-66.61|<0.001
74038670|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.74|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-65.56|-51.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.93|-65.56|<0.001
74038671|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.92|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-42.09|-27.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-27.75|-42.09|<0.001
74038672|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.64|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-46.57|-32.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.71|-46.57|<0.001
74038673|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.86|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-59.66|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.05|-59.66|<0.001
74038674|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.14|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-60.66|-51.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.61|-60.66|<0.001
74038675|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.78|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-56.72|-44.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.83|-56.72|<0.001
74038676|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.94|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-61.11|-48.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.76|-61.11|<0.001
74091122|NCT00359788|147736046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.198||||0.0006||95.0|-0.309|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.086|-0.309|0.0006
74091123|NCT00359788|147736047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.0896||95.0|-0.21|0.015|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.015|-0.21|0.0896
74091124|NCT00359788|147736048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.8937||95.0|-0.103|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.118|-0.103|0.8937
74091125|NCT00359788|147736049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.0269||95.0|0.014|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.236|0.014|0.0269
74091126|NCT00359788|147736050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223||||0.0001||95.0|0.111|0.335|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.335|0.111|0.0001
74091127|NCT00359788|147736051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042||||0.7196||95.0|-0.275|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.19|-0.275|0.7196
74091128|NCT00359788|147736052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069||||0.6189||95.0|-0.343|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.205|-0.343|0.6189
74091129|NCT00359788|147736053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073||||0.6197||95.0|-0.36|0.215|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.215|-0.36|0.6197
74008942|NCT01286454|147568262|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|259.4|||||TWO_SIDED|90.0|231.48|290.7||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||290.70|231.48|
74091130|NCT00359788|147736054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.112||||0.4582||95.0|-0.408|0.184|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.184|-0.408|0.4582
74091131|NCT00359788|147736055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.6538||95.0|-0.376|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.236|-0.376|0.6538
74091132|NCT00359788|147736056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145||||0.4145||95.0|-0.495|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.205|-0.495|0.4145
74091133|NCT00359788|147736057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.085||||0.6048||95.0|-0.408|0.238|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.238|-0.408|0.6048
74091134|NCT00359788|147736058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.3137||95.0|-0.503|0.162|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.162|-0.503|0.3137
74091135|NCT00359788|147736059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061||||0.7195||95.0|-0.395|0.273|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.273|-0.395|0.7195
74091136|NCT00359788|147736060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043||||0.7947||95.0|-0.367|0.282|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.282|-0.367|0.7947
74091137|NCT00359788|147736061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.093||||0.6049||95.0|-0.446|0.26|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.26|-0.446|0.6049
74091138|NCT00359788|147736062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047||||0.8109||95.0|-0.437|0.342|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.342|-0.437|0.8109
74091139|NCT00359788|147736063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.527||||0.1471||95.0|-0.186|1.24|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||1.24|-0.186|0.1471
74091140|NCT00359788|147736064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265||||0.3192||95.0|-0.258|0.788|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.788|-0.258|0.3192
74091141|NCT00359788|147736065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.351||||0.182||95.0|-0.165|0.867|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.867|-0.165|0.182
74091142|NCT00359788|147736066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363||||0.1777||95.0|-0.166|0.893|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.893|-0.166|0.1777
74091143|NCT00359788|147736067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363||||0.1805||95.0|-0.169|0.895|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.895|-0.169|0.1805
74091144|NCT00359788|147736068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372||||0.1777||95.0|-0.17|0.913|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.913|-0.17|0.1777
74091145|NCT00359788|147736069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.5725||95.0|-0.395|0.714|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.714|-0.395|0.5725
74091146|NCT00359788|147736070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121||||0.6765||95.0|-0.449|0.69|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.69|-0.449|0.6765
74091147|NCT00359788|147736071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247||||0.3943||95.0|-0.323|0.818|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.818|-0.323|0.3943
74091148|NCT00359788|147736072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291||||0.3091||95.0|-0.271|0.852|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.852|-0.271|0.3091
74091149|NCT00359788|147736073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317||||0.2911||95.0|-0.273|0.907|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.907|-0.273|0.2911
74006348|NCT04498169|147562431|SUPERIORITY|With a sample size of up-to 20 subjects within a treatment group, the study had 80% power to demonstrate a statistically significant mean change from baseline, assuming the true effect size (mean change / SD) was 0.577 or larger (e.g. assuming the true mean change from baseline was 34.6 μm and the SD was 60 μm), a one sample t-test and a two-sided alpha = 0.10.||||||0.0021|||||||One-sample t-test (within group)|||The primary analysis used the mITT population with available data per subject at eye level (ie., ODO). Robustness analyses was also performed based on the MI methodology under different assumptions of missingness and intercurrent events (where missing data or withdrawal due to lack of efficacy or AEs were imputed using FCS regression method and missing data for all other reasons were imputed using worst within subject observation prior to the intercurrent event).||||0.0021
74006349|NCT04682977|147562452|SUPERIORITY||Mean difference (adjusted)|1.58|STANDARD_ERROR_OF_MEAN|0.76||0.04|TWO_SIDED|||||Sidak correction for multiple comparisons.|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.04
74006350|NCT04682977|147562453|SUPERIORITY||Mean difference (adjusted)|1.98|STANDARD_ERROR_OF_MEAN|1.75||0.26|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.26
74006351|NCT04682977|147562454|SUPERIORITY||Mean difference (adjusted)|-1.06|STANDARD_ERROR_OF_MEAN|1.6||0.51|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.51
74006352|NCT04682977|147562455|SUPERIORITY||Mean difference (adjusted)|2.17|STANDARD_ERROR_OF_MEAN|1.78||0.23|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.23
74006353|NCT04682977|147562456|SUPERIORITY||Mean difference (adjusted)|4.65|STANDARD_ERROR_OF_MEAN|5.97||0.44|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.44
74006354|NCT04682977|147562457|SUPERIORITY||Mean difference (adjusted)|4.37|STANDARD_ERROR_OF_MEAN|3.47||0.22|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.22
74006355|NCT04682977|147562458|SUPERIORITY||Mean difference (adjusted)|0.91|STANDARD_ERROR_OF_MEAN|1.8||0.91|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.91
74006356|NCT04682977|147562459|SUPERIORITY||Mean difference (adjusted)|0.18|STANDARD_ERROR_OF_MEAN|0.65||0.78|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.78
74006357|NCT04682977|147562460|SUPERIORITY||Mean difference (adjusted)|-0.12|STANDARD_ERROR_OF_MEAN|0.53||0.83|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.83
74006358|NCT04682977|147562461|SUPERIORITY|||||||0.67||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.67
74006359|NCT04682977|147562462|SUPERIORITY|||||||0.77||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.77
74006360|NCT04682977|147562463|SUPERIORITY|||||||0.79||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.79
74006361|NCT04682977|147562464|SUPERIORITY|||||||0.44||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.44
74006362|NCT04682977|147562465|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p = 0.05|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r||||||0.65
74006363|NCT04682977|147562466|SUPERIORITY|||||||0.66||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.66
74006364|NCT04682977|147562467|SUPERIORITY|||||||0.81||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.81
74006365|NCT04682977|147562468|SUPERIORITY|||||||0.89||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.89
74006366|NCT01383161|147562469|SUPERIORITY|||||||0.5|||||||mixed-effects general linear model|||||||0.5
74006367|NCT01383161|147562469|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
74006368|NCT01383161|147562469|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
74006369|NCT01383161|147562470|SUPERIORITY|||||||0.08|||||||mixed-effects general linear model|||||||0.08
74006370|NCT01383161|147562470|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
74006371|NCT01383161|147562470|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
74006372|NCT01383161|147562471|SUPERIORITY|||||||0.05|||||||mixed-effects general linear model|||||||0.05
74006373|NCT01383161|147562471|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
74006374|NCT01383161|147562471|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
74006375|NCT01383161|147562472|SUPERIORITY|||||||0.08|||||||mixed-effects general linear model|||||||0.08
74006376|NCT01383161|147562472|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||.002
74006377|NCT01383161|147562472|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
74006378|NCT01383161|147562473|SUPERIORITY|||||||0.04|||||||mixed-effects general linear model|||||||0.04
74006379|NCT01383161|147562473|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
74006380|NCT01383161|147562473|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
73878387|NCT00423657|147296140|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95%CI was higher than -10%.|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-5.8|5.0|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.||5.0|-5.8|
73878388|NCT02748863|147296148|SUPERIORITY||Odds Ratio (OR)|717.42|||<|0.0001|TWO_SIDED|95.0|68.0|7569.56|||Regression, Logistic|||||7569.56|68.00|< 0.0001
73878389|NCT02748863|147296149|SUPERIORITY||Odds Ratio (OR)|168.39|||<|0.0001|TWO_SIDED|95.0|21.2|1337.22|||Regression, Logistic|||||1337.22|21.20|< 0.0001
74006381|NCT01383161|147562474|SUPERIORITY|||||||0.3|||||||mixed-effects general linear model|||||||0.3
74006382|NCT01383161|147562474|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
74006383|NCT01383161|147562474|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
74006384|NCT03694418|147562502|OTHER||Incident Rate Ratio|1.73|STANDARD_DEVIATION|0.35|<|0.05|TWO_SIDED|95.0|1.02|2.95|||Wilcoxon (Mann-Whitney)|||||2.95|1.02|<0.05
74006385|NCT03258554|147562520|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.8878|TWO_SIDED|95.0|0.84|2.12||One-sided significance level = 0.2|Log Rank||Reference arm = radiation therapy + cetuximab|Sixty-nine progression-free survival (PFS) events provides 0.80 power for a log-rank test with one-sided alpha of 0.20 to detect an improvement in PFS corresponding to a median of 2.35 years (RT+Durvalumab) compared to 1.53 years (RT+Cetuximab). A hazard ratio (RT+Durvalumab/RT+Cetuximab) ≤ 0.806 would indicate a rejection of the null hypothesis (no difference between the arms) and the study would continue to phase III; otherwise, the study would not continue to phase III.||2.12|0.84|0.8878
74006386|NCT03258554|147562521|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.8175|TWO_SIDED|95.0|0.74|2.28||One-side significance level = 0.025|Log Rank|||||2.28|0.74|0.8175
74006387|NCT03258554|147562522|SUPERIORITY||Hazard Ratio (HR)|1.71||||0.1001|TWO_SIDED|95.0|0.89|3.28||Two-sided significance level = 0.05|Log Rank||Reference level = RT+ Cetuximab|||3.28|0.89|0.1001
74006388|NCT03258554|147562523|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.5197|TWO_SIDED|95.0|0.32|1.77||Two-sided significance level = 0.05|Log Rank||Reference level = RT+ Cetuximab|||1.77|0.32|0.5197
74006389|NCT03258554|147562524|SUPERIORITY||Hazard Ratio (HR)|1.75||||0.3201|TWO_SIDED|95.0|0.57|5.38||Two-sided significance level = 0.05|Log Rank|||||5.38|0.57|0.3201
74006390|NCT03258554|147562525|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.00
73878390|NCT02748863|147296150|SUPERIORITY||Risk Difference (RD)|38.75|||<|0.0001|TWO_SIDED|95.0|27.41|50.09|||t-test, 2 sided|||||50.09|27.41|< 0.0001
73878391|NCT02748863|147296150|SUPERIORITY||Risk Difference (RD)|36.48|||<|0.0001|TWO_SIDED|95.0|25.19|47.76|||t-test, 2 sided|||||47.76|25.19|< 0.0001
73878392|NCT02748863|147296152|SUPERIORITY||Odds Ratio (OR)|400.58|||<|0.0001|TWO_SIDED|95.0|47.48|3379.99|||Regression, Logistic|||||3379.99|47.48|< 0.0001
73878393|NCT02795117|147296153|EQUIVALENCE|provides 85% power of success|equivalence ratio|96.4|||||TWO_SIDED|90.0|91.0|105.4||No p-value was calculated for bioequivalence, only a T/R ratio and 90% confidence interval|ANOVA|||||105.4|91.0|
73878394|NCT02795117|147296154|EQUIVALENCE|provides 85% power of success|Equivalence difference|-6.48|||||TWO_SIDED|90.0|-18.31|1.85|||Wald's method|||||1.85|-18.31|
73878395|NCT00657046|147296164|SUPERIORITY_OR_OTHER|||||||0.693|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.693
73878396|NCT00657046|147296164|SUPERIORITY_OR_OTHER|||||||0.807|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.807
73878397|NCT00657046|147296165|SUPERIORITY_OR_OTHER|||||||0.212|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.212
73878398|NCT00657046|147296165|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.230
73878399|NCT00657046|147296166|SUPERIORITY_OR_OTHER|||||||0.712|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.712
73878400|NCT00657046|147296166|SUPERIORITY_OR_OTHER|||||||0.607|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.607
74006391|NCT03258554|147562526|SUPERIORITY|||||||0.0688||||||Two-side significance level = 0.05|Fisher Exact|||||||0.0688
74006392|NCT03258554|147562529|SUPERIORITY||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.62|1.97|||||Reference arm = RT + Cetuximab|CPS ≥ 1||1.97|0.62|
74006393|NCT03258554|147562529|SUPERIORITY||Cox Proportional Hazard|1.64|||||TWO_SIDED|95.0|0.66|4.06|||||Reference arm = RT + Cetuximab|CPS = 0||4.06|0.66|
74006394|NCT03258554|147562529|SUPERIORITY|||||||0.41||||||Testing the interaction of treatment arm and PD-L1 expression (CPS ≥ 1, CPS = 0)|Regression, Cox|||Interaction||||0.41
74006395|NCT03258554|147562530|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.57|2.51|||||Reference arm = RT + cetuximab|p16-positive||2.51|0.57|
74006396|NCT03258554|147562530|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|0.83|2.89|||||Reference arm = RT + cetuximab|p16-negative||2.89|0.83|
74006397|NCT03258554|147562530|SUPERIORITY|||||||0.61||||||Testing the interaction of treatment arm and p16 status (positive, negative)|Regression, Cox|||Interaction||||0.61
74006398|NCT01601847|147562535|SUPERIORITY||Risk Ratio (RR)|0.66||||0.02|TWO_SIDED|95.0|0.47|0.94|||Poisson|Poisson regression using GEE with robust variance estimation (e.g. Zou, American Journal Epidemiology, 2004)||||0.94|0.47|0.02
74006399|NCT01601847|147562535|SUPERIORITY||Odds Ratio (OR)|0.522||||0.0185|TWO_SIDED|95.0|0.304|0.897|||logistic regression with GEE|||||0.897|0.304|0.0185
74006400|NCT01601847|147562536|SUPERIORITY|||||||0.228|||||||Regression, Logistic|||For secondary outcomes, GEE is used to assess randomization arm association.||||0.228
74006401|NCT01601847|147562537|SUPERIORITY|||||||0.798|||||||Regression, Logistic|||||||0.798
74006402|NCT01284062|147562538|SUPERIORITY_OR_OTHER||Least squares (LS) mean|0.41|||||TWO_SIDED|80.0|0.225|0.766|||||LS mean and confidence interval (CI) were based on back log-transformation of those from the analysis of covariance (ANCOVA) model.|||0.766|0.225|
74006403|NCT01284062|147562538|SUPERIORITY_OR_OTHER||LS mean|0.29|||||TWO_SIDED|80.0|0.187|0.446|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||0.446|0.187|
74006404|NCT01284062|147562538|SUPERIORITY_OR_OTHER||LS mean|0.79|||||TWO_SIDED|80.0|0.517|1.203|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||1.203|0.517|
73878401|NCT00657046|147296167|SUPERIORITY_OR_OTHER|||||||0.4602|||||||ANCOVA|GLM model with baseline as a covariate||||||0.4602
73878402|NCT00657046|147296167|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|GLM model with baseline as a covariate||||||0.940
73878403|NCT00657046|147296168|SUPERIORITY_OR_OTHER|||||||0.376|||||||ANCOVA|GLM model with baseline as a covariate||||||0.376
74006405|NCT01284062|147562538|SUPERIORITY_OR_OTHER||LS mean|1.24|||||TWO_SIDED|80.0|0.794|1.949|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||1.949|0.794|
74006406|NCT01284062|147562538|SUPERIORITY_OR_OTHER||LS mean ratio|0.7||||0.532|TWO_SIDED|80.0|0.329|1.472|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.472|0.329|0.5320
74006407|NCT01284062|147562538|SUPERIORITY_OR_OTHER||LS mean ratio|1.9||||0.27|TWO_SIDED|80.0|0.9|4.013|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||4.013|0.900|0.2700
74006408|NCT01284062|147562538|SUPERIORITY_OR_OTHER||LS mean ratio|3.0||||0.0666|TWO_SIDED|80.0|1.403|6.409|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||6.409|1.403|0.0666
74006409|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.7|||||TWO_SIDED|80.0|0.466|1.048||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.048|0.466|
74006410|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.81|||||TWO_SIDED|80.0|0.552|1.185||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.185|0.552|
74006411|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.71|||||TWO_SIDED|80.0|0.488|1.027||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.027|0.488|
74006412|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.77|||||TWO_SIDED|80.0|0.5|1.195||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.195|0.500|
74006413|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.92|||||TWO_SIDED|80.0|0.631|1.328||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.328|0.631|
74006414|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.47|||||TWO_SIDED|80.0|0.339|0.655||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.655|0.339|
73878404|NCT00657046|147296168|SUPERIORITY_OR_OTHER|||||||0.903|||||||ANCOVA|GLM model with baseline as a covariate||||||0.903
73878405|NCT00657046|147296169|SUPERIORITY_OR_OTHER|||||||0.319|||||||ANCOVA|GLM model with baseline as a covariate||||||0.319
73878406|NCT00657046|147296169|SUPERIORITY_OR_OTHER|||||||0.408|||||||ANCOVA|GLM model with baseline as a covariate||||||0.408
73878407|NCT00657046|147296170|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|GLM model with baseline as a covariate||||||0.004
73878408|NCT00657046|147296170|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|GLM model with baseline as a covariate||||||0.030
73878409|NCT00657046|147296171|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANCOVA|GLM model with baseline as a covariate||||||0.025
73878410|NCT00657046|147296171|SUPERIORITY_OR_OTHER|||||||0.022|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.022
73878411|NCT00657046|147296172|SUPERIORITY_OR_OTHER|||||||0.082|||||||Fisher Exact|||||||0.082
73878412|NCT00657046|147296172|SUPERIORITY_OR_OTHER|||||||0.008|||||||Fisher Exact|||||||0.008
73878413|NCT00851786|147296185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.45|0.69||The p-value was adjusted for baseline gpELISA titer, measurement time (week 6 vs. week 12), CD4 stratum and age.|Linear mixed effect model|Natural log transformed gpELISA titers after one or two doses of vaccine was modeled.||Null hypothesis: VZV antibody titer measured by gpELISA, after 1 or 2 doses of ZOSTAVAX/placebo is the same between ZOSTAVAX arm and the placebo arm||0.69|0.45|<.001
73878414|NCT01690052|147296248|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|The p-value is calculated from the ANOVA||||||0.05
73878415|NCT02421172|147296250|SUPERIORITY_OR_OTHER_LEGACY||Posterior probablility|0.9729||||||||||||||||||
73878416|NCT00683878|147296256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1175||0.0007|TWO_SIDED|95.0|-0.63|-0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.17|-0.63|0.0007
73878417|NCT00683878|147296256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.1175|<|0.0001|TWO_SIDED|95.0|-0.78|-0.31||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.31|-0.78|<0.0001
74006415|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.92|||||TWO_SIDED|80.0|0.669|1.269||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.269|0.669|
74006416|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.55|||||TWO_SIDED|80.0|0.388|0.779||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.779|0.388|
74006417|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.78|||||TWO_SIDED|80.0|0.454|1.331||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.331|0.454|
74006418|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.36|||||TWO_SIDED|80.0|0.236|0.553||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.553|0.236|
74006419|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|1.14|||||TWO_SIDED|80.0|0.757|1.722||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.722|0.757|
74006420|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.52|||||TWO_SIDED|80.0|0.338|0.788||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.788|0.338|
74006421|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.64|||||TWO_SIDED|80.0|0.374|1.084||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.084|0.374|
74006422|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.19|||||TWO_SIDED|80.0|0.122|0.297||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.297|0.122|
74006423|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.96|||||TWO_SIDED|80.0|0.623|1.465||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.465|0.623|
74006424|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean|0.67|||||TWO_SIDED|80.0|0.411|1.076||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.076|0.411|
73878418|NCT00683878|147296257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.0|STANDARD_ERROR_OF_MEAN|9.007|<|0.0001|TWO_SIDED|95.0|-68.7|-33.2||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-33.2|-68.7|<0.0001
73878419|NCT00683878|147296257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.3|STANDARD_ERROR_OF_MEAN|9.039|<|0.0001|TWO_SIDED|95.0|-71.1|-35.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-35.6|-71.1|<0.0001
73878420|NCT00683878|147296258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.3896|<|0.0001|TWO_SIDED|95.0|-2.32|-0.79||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.79|-2.32|<0.0001
74006425|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|1.16||||0.7352|TWO_SIDED|80.0|0.663|2.021|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.021|0.663|0.7352
74006426|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|1.01||||0.9754|TWO_SIDED|80.0|0.586|1.753|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.753|0.586|0.9754
74006427|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|1.11||||0.8277|TWO_SIDED|80.0|0.609|2.008|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.008|0.609|0.8277
74006428|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|0.51||||0.0885|TWO_SIDED|80.0|0.313|0.846|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.846|0.313|0.0885
74006429|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|1.01||||0.9856|TWO_SIDED|80.0|0.617|1.644|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.644|0.617|0.9856
74006430|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|0.6||||0.1996|TWO_SIDED|80.0|0.361|1.0|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.000|0.361|0.1996
74006431|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|0.46||||0.1553|TWO_SIDED|80.0|0.233|0.926|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.926|0.233|0.1553
74006432|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|1.47||||0.4633|TWO_SIDED|80.0|0.748|2.882|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.882|0.748|0.4633
74006433|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|0.66||||0.4409|TWO_SIDED|80.0|0.335|1.316|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.316|0.335|0.4409
74006434|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|0.3||||0.0283|TWO_SIDED|80.0|0.15|0.598|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.598|0.150|0.0283
74038677|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.34|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-59.94|-50.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.74|-59.94|<0.001
73878421|NCT00683878|147296258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|0.3896|<|0.0001|TWO_SIDED|95.0|-2.55|-1.02||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-1.02|-2.55|<0.0001
73878422|NCT00683878|147296259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|4.088|<|0.0001|TWO_SIDED|95.0|-27.5|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-11.4|-27.5|<0.0001
73878423|NCT00683878|147296259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1|STANDARD_ERROR_OF_MEAN|4.082|<|0.0001|TWO_SIDED|95.0|-32.2|-16.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-16.1|-32.2|<0.0001
73878424|NCT00683878|147296260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|5.119||0.0496|TWO_SIDED|95.0|0.0|20.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||20.1|0.0|0.0496
73878425|NCT00683878|147296260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|5.253||0.0018|TWO_SIDED|95.0|6.1|26.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||26.7|6.1|0.0018
73878426|NCT00683878|147296261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.6006||0.1566|TWO_SIDED|95.0|-2.03|0.33||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||0.33|-2.03|0.1566
74006435|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|1.5||||0.4434|TWO_SIDED|80.0|0.758|2.97|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.970|0.758|0.4434
74006436|NCT01284062|147562545|SUPERIORITY_OR_OTHER||LS mean ratio|1.04||||0.9372|TWO_SIDED|80.0|0.51|2.141|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.141|0.510|0.9372
74006437|NCT01284062|147562550|SUPERIORITY_OR_OTHER||percentage of participants|41.67|||||TWO_SIDED|80.0|25.53|59.81|||||CI was assessed by Wilson score method.|||59.81|25.53|
74006438|NCT01284062|147562550|SUPERIORITY_OR_OTHER||percentage of participants|60.0|||||TWO_SIDED|80.0|43.59|74.43|||||CI was assessed by Wilson score method.|||74.43|43.59|
74006439|NCT01284062|147562550|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|80.0|34.74|65.26|||||CI was assessed by Wilson score method.|||65.26|34.74|
74091150|NCT00359788|147736074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108||||0.7458||95.0|-0.549|0.766|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.766|-0.549|0.7458
73957244|NCT04771273|147450413|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-56.26|||<|0.0001|TWO_SIDED|95.0|-66.76|-45.77||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg-Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-45.77|-66.76|<.0001
73957245|NCT04771273|147450414|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|1.61||||0.1894|TWO_SIDED|95.0|0.79|3.26||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||3.26|0.79|0.1894
73957246|NCT04771273|147450414|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.0||||0.0685|TWO_SIDED|95.0|0.95|4.2||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.20|0.95|0.0685
73957247|NCT04771273|147450414|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|3.37||||0.0028|TWO_SIDED|95.0|1.52|7.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||7.45|1.52|0.0028
73957248|NCT04771273|147450415|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.02||||0.0663|TWO_SIDED|95.0|0.95|4.27||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.27|0.95|0.0663
73957249|NCT04771273|147450415|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.01||||0.0672|TWO_SIDED|95.0|0.95|4.23||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.23|0.95|0.0672
73957250|NCT04771273|147450415|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.11||||0.0512|TWO_SIDED|95.0|1.0|4.46||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.46|1.00|0.0512
73957251|NCT03693742|147450461|SUPERIORITY||||||<|0.001||||||A P value of less than 0.05 was considered significant.|Mixed Models Analysis|||"Null hypothesis is that there was no difference in uptake of F18-DCFPyL between the MSG and placebo groups.~A sample size of 10 achieves 100% power to detect a mean of paired differences of 5.0 (33%) with an estimated standard deviation of differences of 1.0 and with a significance level (alpha) of 0.05 using a one-sided paired t-test. If the estimated standard deviation of differences is 5.0, a sample size of 10 achieves 90% power to detect a mean difference of 5.0 with an alpha of 0.05."||||<0.001
73957252|NCT01304147|147450479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|3.9|11.3|||Paired t-test, 2 sided|||within-subject crossover design||11.3|3.9|<0.001
73957253|NCT01278862|147450490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2423|||||||Fisher Exact|||null hypothesis no difference in color match||||0.2423
73957254|NCT01278862|147450490|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in margin discoloration||||>0.999
73957255|NCT01278862|147450490|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in crown fracture||||>0.999
73957256|NCT01278862|147450490|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in Proximal Contact - Mesial||||>0.999
73957257|NCT01278862|147450490|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in proximal contact - distal||||>0.999
73957258|NCT01278862|147450491|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in gingival index||||>0.999
73957259|NCT01278862|147450491|SUPERIORITY|||||||0.524|||||||Fisher Exact|||null hypothesis no difference in plaque index||||0.5240
73957260|NCT04520165|147450492|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
73957261|NCT04520165|147450494|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
73957262|NCT04520165|147450495|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
73957263|NCT00798265|147450548|OTHER|||||||0.002||||||The reported p-value is representative of the changes in HPV-16 at 7 months in Cohort 1.|Spearman correlation (non-parametric)|||||||0.0020
73957264|NCT00798265|147450548|OTHER||||||<|0.0001||||||The reported p-value is representative of the changes in HPV-18 at 7 months in Cohort 1.|Spearman correlation (non-parametric)|||||||<.0001
73957265|NCT00798265|147450548|OTHER|||||||0.0002||||||The reported p-value is representative of the changes in HPV-16 at 7 months in Cohort 2.|Spearman correlation (non-parametric)|||||||0.0002
73957266|NCT00798265|147450548|OTHER||||||<|0.0001||||||The reported p-value is representative of the changes in HPV-18 at 7 months in Cohort 2.|Spearman correlation (non-parametric)|||||||<.0001
73957267|NCT02085356|147450630|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|||||||||||||
73957268|NCT02085356|147450631|OTHER||Odds Ratio (OR)|0.32|||||TWO_SIDED|||||||||||||
73957269|NCT02085356|147450632|OTHER|||||||0.605|||||||Mixed Models Analysis|||||||0.605
74091151|NCT00359788|147736075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.698||||0.0004||95.0|4.836|16.56|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||16.56|4.836|0.0004
73878427|NCT00683878|147296261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.5995||0.0101|TWO_SIDED|95.0|-2.73|-0.37||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.37|-2.73|0.0101
74006440|NCT01284062|147562550|SUPERIORITY_OR_OTHER||percentage of participants|15.38|||||TWO_SIDED|80.0|6.58|31.96|||||CI was assessed by Wilson score method.|||31.96|6.58|
74006441|NCT01284062|147562550|SUPERIORITY_OR_OTHER||percent difference|18.33||||0.4495|TWO_SIDED|80.0|-6.13|39.98|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||39.98|-6.13|0.4495
74006442|NCT01284062|147562550|SUPERIORITY_OR_OTHER||percent difference|8.33||||0.7177|TWO_SIDED|80.0|-15.37|30.54|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||30.54|-15.37|0.7177
74006443|NCT01284062|147562550|SUPERIORITY_OR_OTHER||percent difference|-26.28||||0.2016|TWO_SIDED|80.0|-46.45|-3.15|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||-3.15|-46.45|0.2016
74006444|NCT01284062|147562551|SUPERIORITY_OR_OTHER||percentage of participants|16.67|||||TWO_SIDED|80.0|7.14|34.22|||||CI was assessed by Wilson score method.|||34.22|7.14|
74006445|NCT01284062|147562551|SUPERIORITY_OR_OTHER||percentage of participants|33.33|||||TWO_SIDED|80.0|20.08|49.88|||||CI was assessed by Wilson score method.|||49.88|20.08|
74006446|NCT01284062|147562551|SUPERIORITY_OR_OTHER||percentage of participants|18.75|||||TWO_SIDED|80.0|9.4|33.92|||||CI was assessed by Wilson score method.|||33.92|9.40|
74006447|NCT01284062|147562551|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|80.0|0.0|11.22|||||CI was assessed by Wilson score method.|||11.22|0.00|
74006448|NCT01284062|147562551|SUPERIORITY_OR_OTHER||percent difference|16.67||||0.4082|TWO_SIDED|80.0|-5.33|35.76|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||35.76|-5.33|0.4082
74006449|NCT01284062|147562551|SUPERIORITY_OR_OTHER||percent difference|2.08||||1|TWO_SIDED|80.0|-17.8|19.99|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||19.99|-17.80|1.0000
74006450|NCT01284062|147562551|SUPERIORITY_OR_OTHER||percent difference|-16.67||||0.22|TWO_SIDED|80.0|-34.22|-1.95|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||-1.95|-34.22|0.2200
74006451|NCT01284062|147562552|SUPERIORITY_OR_OTHER||LS mean|-1.32|||||TWO_SIDED|80.0|-2.332|-0.3||||||||-0.300|-2.332|
74006452|NCT01284062|147562552|SUPERIORITY_OR_OTHER||LS mean|-2.28|||||TWO_SIDED|80.0|-3.19|-1.374||||||||-1.374|-3.190|
74091152|NCT00359788|147736076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.257||||0.0023||95.0|4.055|18.458|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||18.458|4.055|0.0023
73878428|NCT00683878|147296262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.4838|||TWO_SIDED|95.0|-2.53|-0.62||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. The comparison was stopped due to the preceding test (PLACEBO + Pio vs Dapa 5MG + Pio) not statistically significant P value = 0.1566.|ANCOVA|||||-0.62|-2.53|
73878429|NCT00683878|147296262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.4688|<|0.0001|TWO_SIDED|95.0|-2.83|-0.98||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.98|-2.83|<0.0001
74006453|NCT01284062|147562552|SUPERIORITY_OR_OTHER||LS mean|-2.3|||||TWO_SIDED|80.0|-3.178|-1.419||||||||-1.419|-3.178|
74006454|NCT01284062|147562552|SUPERIORITY_OR_OTHER||LS mean|-0.79|||||TWO_SIDED|80.0|-1.761|0.19||||||||0.190|-1.761|
74006455|NCT01284062|147562552|SUPERIORITY_OR_OTHER||LS mean difference|-0.97||||0.3639|TWO_SIDED|80.0|-2.335|0.403|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||0.403|-2.335|0.3639
74006456|NCT01284062|147562552|SUPERIORITY_OR_OTHER||LS mean difference|-0.98||||0.3446|TWO_SIDED|80.0|-2.32|0.355|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||0.355|-2.320|0.3446
74006457|NCT01284062|147562552|SUPERIORITY_OR_OTHER||LS mean difference|0.53||||0.6285|TWO_SIDED|80.0|-0.884|1.945|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||1.945|-0.884|0.6285
74006458|NCT00448435|147562604|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin + or - 15 L/min|Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|5.91||0.6383||95.0|-9.1|14.69||Confidence Interval|Mixed Models Analysis|||Difference between treatments \[(SLM + FP)- SFC\](SE) 2.8 (5.91)||14.69|-9.10|0.6383
74006459|NCT01387230|147562618|SUPERIORITY_OR_OTHER||Least squares mean difference|0.127|||<|0.001|TWO_SIDED|95.0|0.052|0.202|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 62.5 µg minus Placebo.|||0.202|0.052|<0.001
74006460|NCT01387230|147562618|SUPERIORITY_OR_OTHER||Least squares mean difference|0.152|||<|0.001|TWO_SIDED|95.0|0.076|0.229|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 125 µg minus Placebo.|||0.229|0.076|<0.001
74006461|NCT02979925|147562625|SUPERIORITY|||||||0.246|||||||Mixed Models Analysis|||||||0.246
74006462|NCT02979925|147562626|SUPERIORITY|||||||0.651|||||||Mixed Models Analysis|||||||0.651
74006463|NCT02979925|147562627|SUPERIORITY|||||||0.902|||||||Mixed Models Analysis|||||||0.902
74006464|NCT05090995|147562628|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74006465|NCT05090995|147562629|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74006466|NCT05090995|147562630|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74006467|NCT05090995|147562631|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74006468|NCT05090995|147562632|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||For baseline consequences||||<.0001
74006469|NCT05090995|147562632|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||For effects with time||||<.0001
74006470|NCT05090995|147562633|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
74006471|NCT05090995|147562634|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Effect of baseline sleep scores||||<.0001
74006472|NCT05090995|147562634|OTHER|||||||0.04|||||||Mixed Models Analysis|||For effects with time||||0.04
74006473|NCT05090995|147562635|OTHER|||||||0.02|||||||Mixed Models Analysis|||For interaction between treatment group and time||||0.02
74006474|NCT05090995|147562635|OTHER|||||||0.02|||||||Mixed Models Analysis|||Main effects of sex||||0.02
73878430|NCT04073186|147296285|SUPERIORITY|The superiority of the First wearing Cycle was concluded if the lower confidence limit of leastsquare mean as greater than 32.|Least-square Mean|59.3|STANDARD_ERROR_OF_MEAN|2.37|||TWO_SIDED|95.0|54.6|64.0|||Linear Mixed Model|the Kenward and Roger method was used for the denominator degrees of freedom.||||64.0|54.6|
74006475|NCT05090995|147562635|OTHER|||||||0.0007|||||||Mixed Models Analysis|||Main effects of type of day of the week (weekday vs. weekend)||||0.0007
74006476|NCT05090995|147562635|OTHER|||||||0.02|||||||Mixed Models Analysis|||||||0.02
74006477|NCT05090995|147562636|OTHER|||||||0.0001|||||||Mixed Models Analysis|||Main effect of day of the week.||||0.0001
74006478|NCT05090995|147562637|OTHER|||||||0.04|||||||Mixed Models Analysis|||For interaction between treatment condition and time||||0.04
74006479|NCT05090995|147562637|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Main effects of sex||||<.0001
74006480|NCT05090995|147562637|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Main effects of type of day of the week (weekday vs. weekend)||||<0.0001
74006481|NCT05090995|147562637|OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
74006482|NCT02499770|147562640|OTHER||||||=|0.0097||||||The p-value was calculated using the stratified log-rank test to account for the baseline ECOG status (0-1 vs 2) as the stratification factor. Significance level was set as two-sided 0.2.|Stratified log-rank test|p-value calculated using stratified log-rank test with baseline ECOG status (0-1 vs 2) as stratification factor. Significance level was two-sided 0.2.||||||= 0.0097
74006483|NCT05564299|147562697|OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test||||0.053
74006484|NCT00447382|147562707|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|1.04||||0.649||95.0|0.86|1.26|||ANOVA|Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data).|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|"Null hypothesis:Treatment with detemir produced with the NN729 process result in a similar change in cross reacting antibody levels as the NN304 process. Alternative hypothesis: change in antibody levels differ after treatment with detemir produced by the two manufacturing processes.~The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA."||1.26|0.86|0.649
74006485|NCT00447382|147562709|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.03||||0.758||95.0|-0.21|0.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.||0.15|-0.21|0.758
74038678|NCT01763866|147630758|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.87|STANDARD_ERROR_OF_MEAN|3.24|<|0.001|TWO_SIDED|95.0|-63.27|-50.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-50.46|-63.27|<0.001
73878431|NCT04073186|147296286|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.10 logMAR.|Least-square Mean|-0.084|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.124|-0.044||Distance (4 Meter)|Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom.||||-0.044|-0.124|
73878432|NCT04073186|147296286|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR.|Least-square Mean|-0.028|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.068|0.012|||Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom||Intermediate (64 CM)||0.012|-0.068|
74006486|NCT00447382|147562710|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.1||||0.812||95.0|-0.89|0.7|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.||0.7|-0.89|0.812
74006487|NCT00447382|147562712|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|0.93||||0.15||95.0|0.84|1.03|||ANOVA|Adjustments:Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.||1.03|0.84|0.15
74006488|NCT00447382|147562713|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|1.0||||0.966||95.0|0.87|1.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.||1.15|0.87|0.966
74006489|NCT02673619|147562732|OTHER||Percentage difference|25.0|||||TWO_SIDED|90.0|-21.1|75.1||||||||75.1|-21.1|
74006490|NCT02673619|147562732|OTHER||Percentage difference|25.5|||||TWO_SIDED|90.0|-10.2|59.2||||||||59.2|-10.2|
74006491|NCT02673619|147562733|OTHER||Percentage Difference|-16.2|||||TWO_SIDED|90.0|-59.7|32.0||||||||32.0|-59.7|
73957270|NCT02085356|147450633|OTHER|||||||0.902|||||||Chi-squared|||Attendance records could not be retrieved for most participants. However, this analysis was still conducted among those participants who had data.||||0.902
74091153|NCT00359788|147736077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.772||||0.0015||95.0|4.942|20.602|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.602|4.942|0.0015
73957271|NCT02085356|147450634|OTHER|||||||0.869|||||||Mixed Models Analysis|||||||0.869
73957272|NCT02085356|147450634|OTHER||Odds Ratio (OR)|0.32||||0.982|TWO_SIDED||||||Mixed Models Analysis|||||||0.982
74006492|NCT02673619|147562733|OTHER||Percentage Difference|18.0|||||TWO_SIDED|90.0|-18.8|52.1||||||||52.1|-18.8|
74006493|NCT02673619|147562737|OTHER||Percentage Difference|16.2|||||TWO_SIDED|90.0|-32.0|59.7||||||||59.7|-32.0|
74006494|NCT02673619|147562737|OTHER||Percentage Difference|7.5|||||TWO_SIDED|90.0|-27.7|42.3||||||||42.3|-27.7|
74006495|NCT04600336|147562764|SUPERIORITY||Mean Difference (Final Values)|-9.11||||0.0019|TWO_SIDED|90.0|-13.76|-4.46|||t-test, 2 sided|||||-4.46|-13.76|0.0019
74006496|NCT04600336|147562764|SUPERIORITY||Mean Difference (Final Values)|-5.09||||0.0732|TWO_SIDED|90.0|-9.7|-0.48|||t-test, 2 sided|||||-0.48|-9.70|0.0732
74006497|NCT04600336|147562767|SUPERIORITY|||||||0.012|||||||Kruskal-Wallis|||||||0.0120
74006498|NCT04600336|147562770|SUPERIORITY|||||||0.0057|||||||Kruskal-Wallis|||||||0.0057
74006499|NCT04561765|147562848|SUPERIORITY|||||||0.051|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge||||0.051
74006500|NCT04561765|147562848|SUPERIORITY|||||||0.206|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.206
74006501|NCT04561765|147562848|SUPERIORITY|||||||0.765|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge||||0.765
74006502|NCT04561765|147562848|SUPERIORITY|||||||0.991|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at follow-up.||||0.991
74006503|NCT04561765|147562848|SUPERIORITY|||||||0.963|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.963
74006504|NCT04561765|147562848|SUPERIORITY|||||||0.916|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.916
74006505|NCT04561765|147562849|SUPERIORITY|||||||0.005|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.005
74006506|NCT04561765|147562849|SUPERIORITY|||||||0.27|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.270
74006507|NCT04561765|147562849|SUPERIORITY|||||||0.177|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.177
74006508|NCT04561765|147562849|SUPERIORITY|||||||0.3|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P Value at follow-up.||||0.300
74006509|NCT04561765|147562849|SUPERIORITY|||||||0.996|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.996
74006510|NCT04561765|147562849|SUPERIORITY|||||||0.334|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.334
74006511|NCT04561765|147562851|SUPERIORITY|||||||0.212|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.212
74006512|NCT04561765|147562851|SUPERIORITY|||||||0.965|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.965
74006513|NCT04561765|147562851|SUPERIORITY|||||||0.294|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.294
74006514|NCT04561765|147562851|SUPERIORITY|||||||0.207|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.207
74006515|NCT04561765|147562851|SUPERIORITY|||||||0.158|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.158
74006516|NCT04561765|147562851|SUPERIORITY|||||||0.988|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.988
74006517|NCT04561765|147562853|SUPERIORITY|||||||0.295|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.295
74006518|NCT04561765|147562853|SUPERIORITY|||||||0.718|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.718
74006519|NCT04561765|147562853|SUPERIORITY|||||||0.738|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.738
74006520|NCT04561765|147562853|SUPERIORITY|||||||0.797|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.797
74006521|NCT04561765|147562853|SUPERIORITY|||||||0.26|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.260
74006522|NCT04561765|147562853|SUPERIORITY|||||||0.616|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.616
74006523|NCT04561765|147562854|SUPERIORITY|||||||0.333|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.333
74006524|NCT04561765|147562854|SUPERIORITY|||||||0.003|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.003
74006525|NCT04561765|147562854|SUPERIORITY|||||||0.106|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.106
74006526|NCT04561765|147562854|SUPERIORITY|||||||0.541|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.541
74006527|NCT04561765|147562854|SUPERIORITY|||||||0.202|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.202
74006528|NCT04561765|147562854|SUPERIORITY|||||||0.791|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.791
74006529|NCT04561765|147562855|SUPERIORITY|||||||0.026|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.026
73957273|NCT00739102|147450635|SUPERIORITY_OR_OTHER||Proportion - 12-month patency rate|0.665|STANDARD_ERROR_OF_MEAN|0.032||0.437|TWO_SIDED|95.0|0.6|0.725||The observed rate of primary patency at 12 month was 66.5% (143/215) with a lower 95% confidence interval of 60.0%.|Agresti-Coull method||The 95% confidence intervals and the standard error were calculated using the Agresti-Coull method|The null hypothesis to be tested was Ho: P = 0.66 against Ha: P \> 0.66, where 0.66 was the Objective Performance Criteria (OPC). A sample size of 212 subjects was required to achieve 90% power to reject the 66% 12-months patency rate at a one-sided 2.5% significance level when the unknown true patency is at 76%.||0.725|0.6|0.437
74038679|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.79|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-64.03|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.55|-64.03|<0.001
74038680|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.36|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-53.2|-41.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.52|-53.20|<0.001
74038681|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.92|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|-40.23|-29.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.60|-40.23|<0.001
74091154|NCT00359788|147736078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.568||||0.0013||95.0|5.342|21.795|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.795|5.342|0.0013
74091155|NCT00359788|147736079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.052||||0.005||95.0|3.676|20.428|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.428|3.676|0.005
74091156|NCT00359788|147736080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.107||||0.0159||95.0|2.095|20.119|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.119|2.095|0.0159
74091157|NCT00359788|147736081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.057||||0.0219||95.0|1.613|20.501|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.501|1.613|0.0219
74091158|NCT00359788|147736082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.655||||0.0048||95.0|4.207|23.104|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||23.104|4.207|0.0048
73957274|NCT00739102|147450637|SUPERIORITY_OR_OTHER||Death Rate (%)|2.1|||||TWO_SIDED|95.0|0.7|4.9||||||||4.9|0.7|
73957275|NCT00739102|147450638|SUPERIORITY_OR_OTHER||Index Limb Amputation Rate (%)|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
73957276|NCT00739102|147450639|SUPERIORITY_OR_OTHER||Clinically Driven TVR Rate (%)|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
73957277|NCT00739102|147450640|SUPERIORITY_OR_OTHER||Clinically Driven TVR Rate (%)|13.6|||||TWO_SIDED|95.0|9.5|18.6||||||||18.6|9.5|
73957278|NCT00739102|147450641|SUPERIORITY_OR_OTHER||Stent Fracture Rate (%)|1.5|||||TWO_SIDED|95.0|0.3|4.4||||||||4.4|0.3|
73957279|NCT00739102|147450642|SUPERIORITY_OR_OTHER||Index Limb Ischemia Rate (%)|5.6||||||95.0||||||||||||
73957280|NCT00739102|147450643|SUPERIORITY_OR_OTHER||Primary safety endpoint rate (%)|100.0|||<|0.001|TWO_SIDED|95.0|98.2|100.0|||Agresti-Coull method|||The null hypothesis to be tested was Ho: P = 0.88 against Ha: P \> 0.88, where 0.88 was the Objective Performance Criteria (OPC).||100|98.2|<0.001
73957281|NCT00739102|147450644|SUPERIORITY_OR_OTHER||Index Limb Ischemia Rate (%)|8.4||||||95.0||||||||||||
73957282|NCT00739102|147450647|SUPERIORITY_OR_OTHER||Major adverse event rate (%)|14.4|||||TWO_SIDED|95.0|10.2|19.5||||||||19.5|10.2|
73957283|NCT03720990|147450675|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
73957284|NCT02380742|147450676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87|STANDARD_ERROR_OF_MEAN|0.47||0.02|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain.||||.02
73957285|NCT02380742|147450677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|0.87||0.03|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for investigator training and pessary type.||||.03
73957286|NCT02380742|147450678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.811|STANDARD_ERROR_OF_MEAN|0.83||0.03|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain and patient age.||||.03
73957287|NCT02380742|147450679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|0.63||0.09|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at insertion were the same between the lidocaine and placebo groups after controlling for baseline pain.||||.09
73957288|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.235|TWO_SIDED|95.0|0.45|1.22|||Univariate logistic regression model|||Comparison between genders: women and men.||1.22|0.45|0.235
73957289|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.331|TWO_SIDED|95.0|0.55|1.22|||Univariate logistic regression model|||Comparison between Age: \<= 55 years and \> 55 years||1.22|0.55|0.331
73957290|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.05|TWO_SIDED|95.0|1.0|2.23|||Univariate logistic regression model|||Comparison between time since initial diagnosis: \>= 10 years and \< 10 years||2.23|1.00|0.050
73957291|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.144|TWO_SIDED|95.0|0.88|2.46|||Univariate logistic regression model|||Comparison between participants without erosive rheumatoid arthritis (RA) and participants with erosive RA||2.46|0.88|0.144
73957292|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.65|||Univariate logistic regression model|||Comparison between DAS-28 score: \<= 5.1 and DAS-28 \>5.1||2.65|1.14|0.010
73957293|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.119|TWO_SIDED|95.0|0.92|2.1|||Univariate logistic regression model|||Comparison between ESR: \<= 28 mm/h and \> 28 mm/h||2.10|0.92|0.119
74038682|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.21|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-42.06|-30.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.35|-42.06|<0.001
74038683|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.4|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-69.27|-53.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.54|-69.27|<0.001
74038684|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.01|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-60.77|-45.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-45.25|-60.77|<0.001
74038685|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.45|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-45.17|-29.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.74|-45.17|<0.001
74038686|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.31|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-42.15|-26.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.47|-42.15|<0.001
74091159|NCT00359788|147736083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.231||||0.0058||95.0|4.153|24.31|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||24.31|4.153|0.0058
74091160|NCT00359788|147736084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.597||||0.0248||95.0|1.483|21.71|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.71|1.483|0.0248
74091161|NCT00359788|147736085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.001||||0.0325||95.0|0.924|21.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.079|0.924|0.0325
74091162|NCT00359788|147736086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.074||||0.0153||95.0|2.726|25.422|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||25.422|2.726|0.0153
74091163|NCT00359788|147736087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.755||||0.6105||95.0|-8.532|5.022|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||5.022|-8.532|0.6105
73957294|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.265|TWO_SIDED|95.0|0.81|2.13|||Univariate logistic regression model|||Comparison between number of participants without anemia and number of participants with anemia||2.13|0.81|0.265
73957295|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.511|TWO_SIDED|95.0|0.77|1.71|||Univariate logistic regression model|||Comparison between dose of corticosteroids: \<= 5 mg and \> 5 mg||1.71|0.77|0.511
73957296|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.153|TWO_SIDED|95.0|0.9|2.0|||Univariate logistic regression model|||Comparison between HAQ score: \<= 1.5 and \> 1.5||2.00|0.90|0.153
73957297|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19|||<|0.001|TWO_SIDED|95.0|1.45|3.31|||Univariate logistic regression model|||Comparison between VAS patient: fatigue \<= 66 and \> 66||3.31|1.45|<0.001
74038687|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.5|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|-61.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.40|-61.60|<0.001
74038688|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.21|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-58.29|-48.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.13|-58.29|<0.001
74038689|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.52|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-57.06|-43.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-43.99|-57.06|<0.001
74091164|NCT00359788|147736088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.842||||0.8249||95.0|-6.642|8.326|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||8.326|-6.642|0.8249
74091165|NCT00359788|147736089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.71||||0.4896||95.0|-5.001|10.421|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||10.421|-5.001|0.4896
74091166|NCT00359788|147736090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.898||||0.0935||95.0|-1.172|14.968|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.968|-1.172|0.0935
74091167|NCT00359788|147736091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.419||||0.4339||95.0|-5.17|12.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||12.007|-5.17|0.4339
74091168|NCT00359788|147736092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.971||||0.845||95.0|-10.74|8.799|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||8.799|-10.74|0.845
74038690|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.95|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-54.43|-39.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.47|-54.43|<0.001
74038691|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.3|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-61.47|-51.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.14|-61.47|<0.001
74038692|NCT01763866|147630759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.73|STANDARD_ERROR_OF_MEAN|3.38|<|0.001|TWO_SIDED|95.0|-59.4|-46.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-46.06|-59.40|<0.001
74038693|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.41|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-50.66|-42.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.15|-50.66|<0.001
74038694|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.69|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-49.75|-39.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.63|-49.75|<0.001
74038695|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.06|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|-30.36|-21.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.75|-30.36|<0.001
74038696|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.59|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|-36.61|-26.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.57|-36.61|<0.001
73878433|NCT04073186|147296286|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR|Least-square Means|0.037|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.003|0.077|||Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom||Near (40 CM)||0.077|-0.003|
74038697|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.48|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-50.69|-38.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-38.27|-50.69|<0.001
74038698|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.85|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-52.48|-41.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.21|-52.48|<0.001
74038699|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.3|STANDARD_ERROR_OF_MEAN|3.09|<|0.001|TWO_SIDED|95.0|-34.39|-22.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-22.21|-34.39|<0.001
74091169|NCT00359788|147736093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194||||0.9696||95.0|-9.811|10.199|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||10.199|-9.811|0.9696
73878434|NCT04073186|147296287|SUPERIORITY|The superiority of the Test lens at 4-week followup compared to it at 2-week follow-up will beconcluded if the lower confidence limit of leastsquare mean difference is greater than 0.|Least-square Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-8.1|-0.1|||Linear Mixed Model|the Kenward and Roger method was used for the denominator degrees of freedom.|LSM difference was calculated as Second Wearing Cycle minus First Wearing Cycle|||-0.1|-8.1|
74038700|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.18|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-33.86|-22.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-22.50|-33.86|<0.001
74038701|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.73|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-49.5|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.97|-49.50|<0.001
74091170|NCT00359788|147736094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.129||||0.3252||95.0|-5.117|15.376|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||15.376|-5.117|0.3252
74091171|NCT00359788|147736095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.062||||0.452||95.0|-6.558|14.683|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.683|-6.558|0.452
74006530|NCT04561765|147562855|SUPERIORITY|||||||0.15|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.15
73957298|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.001|TWO_SIDED|95.0|1.35|3.08|||Univariate logistic regression model|||Comparison between VAS patient: pain \<= 66 and \> 66||3.08|1.35|<0.001
73957299|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.261|TWO_SIDED|95.0|0.86|2.75|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<=30 score and 30 - 59 score||2.75|0.86|0.261
73957300|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.261|TWO_SIDED|95.0|0.67|2.05|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<= 30 and 59 - 77||2.05|0.67|0.261
73957301|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.261|TWO_SIDED|95.0|0.95|2.89|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<= 30 and \> 77||2.89|0.95|0.261
73957302|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08|||<|0.001|TWO_SIDED|95.0|1.38|3.14|||Univariate logistic regression model|||Comparison between VAS patient: global assessment score: \<= 67 and \> 67||3.14|1.38|<0.001
73957303|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.001|TWO_SIDED|95.0|1.5|3.47|||Univariate logistic regression model|||Comparison between SF36 vitality score: \> 33 and \<= 33||3.47|1.50|< 0.001
73957304|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.399|TWO_SIDED|95.0|0.6|1.93|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Doubtful case)||1.93|0.60|0.399
73957305|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.399|TWO_SIDED|95.0|0.48|1.26|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Certain case)||1.26|0.48|0.399
73957306|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.858|TWO_SIDED|95.0|0.65|1.81|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Doubtful case)||1.81|0.65|0.858
73957307|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.858|TWO_SIDED|95.0|0.57|1.52|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Certain case)||1.52|0.57|0.858
73957308|NCT01185522|147450694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.036|TWO_SIDED|95.0|1.03|2.58|||Multivariate logistic regression model|||Comparison between time since initial diagnosis: \>= 10 years and \< 10 years||2.58|1.03|0.036
73957309|NCT01185522|147450695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.004|TWO_SIDED|95.0|1.05|1.28|||Univariate logistic regression model|||Predictive factor: C-Reactive Protein||1.28|1.05|0.004
73957310|NCT01185522|147450695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.013|TWO_SIDED|95.0|1.03|1.27|||Multivariate logistic regression model|||Predictive factor: C-Reactive Protein||1.27|1.03|0.013
73957311|NCT01185522|147450696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.253|TWO_SIDED|95.0|0.99|1.05|||Univariate logistic regression model|||Predictive factor: Tender joint||1.05|0.99|0.253
73957312|NCT01185522|147450696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.021|TWO_SIDED|95.0|1.01|1.09|||Univariate logistic regression model|||Predictive factor : Swollen joint||1.09|1.01|0.021
73957313|NCT00516503|147450708|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
73957314|NCT00516503|147450709|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
73957315|NCT00516503|147450710|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
73957316|NCT01280591|147450740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.3|STANDARD_ERROR_OF_MEAN|13.17||0.0002|TWO_SIDED|95.0|-106.8|-33.7|||ANCOVA|||||-33.7|-106.8|0.0002
73957317|NCT01280591|147450741|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
73957318|NCT01280591|147450742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|70.4|STANDARD_ERROR_OF_MEAN|12.85||0.0001|TWO_SIDED|95.0|28.1|112.7|||ANCOVA|||||112.7|28.1|0.0001
73957319|NCT01280591|147450743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|2.14||0.0007|TWO_SIDED|95.0|3.7|19.7|||ANCOVA|||||19.7|3.7|0.0007
73957320|NCT01280591|147450744|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73957321|NCT01280591|147450745|SUPERIORITY_OR_OTHER|||||||0.0027|||||||Cochran-Mantel-Haenszel|||||||0.0027
74006531|NCT04561765|147562855|SUPERIORITY|||||||0.745|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.745
74006532|NCT04561765|147562855|SUPERIORITY|||||||0.021|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.021
74006533|NCT04561765|147562855|SUPERIORITY|||||||0.155|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.155
74006534|NCT04561765|147562855|SUPERIORITY|||||||0.652|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.652
74006535|NCT04561765|147562856|SUPERIORITY|||||||0.343|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.343
74006536|NCT04561765|147562856|SUPERIORITY|||||||0.995|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.995
74006537|NCT04561765|147562856|SUPERIORITY|||||||0.371|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.371
74006538|NCT04561765|147562856|SUPERIORITY|||||||0.228|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.228
74006539|NCT04561765|147562856|SUPERIORITY|||||||0.282|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.282
74006540|NCT04561765|147562856|SUPERIORITY|||||||0.986|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.986
74006541|NCT04561765|147562857|SUPERIORITY|||||||0.421|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.421
74006542|NCT04561765|147562857|SUPERIORITY|||||||0.556|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.556
74038702|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.01|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-52.46|-41.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.57|-52.46|<0.001
74038703|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.59|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-45.38|-35.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.79|-45.38|<0.001
74038704|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.33|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-46.0|-34.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.66|-46.00|<0.001
74038705|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.05|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-51.76|-42.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.35|-51.76|<0.001
74038706|NCT01763866|147630760|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.62|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-54.27|-42.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-42.98|-54.27|<0.001
74038707|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.83|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|95.0|-51.73|-41.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.94|-51.73|<0.001
74038708|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.86|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-48.43|-37.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.30|-48.43|<0.001
74038709|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.6|STANDARD_ERROR_OF_MEAN|2.51|<|0.001|TWO_SIDED|95.0|-33.56|-23.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.65|-33.56|<0.001
74038710|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.22|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-35.74|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.70|-35.74|<0.001
74038711|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.1|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-51.66|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-38.54|-51.66|<0.001
74038712|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.43|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-49.01|-35.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.85|-49.01|<0.001
74038713|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.26|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-36.68|-23.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.84|-36.68|<0.001
74038714|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.19|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|-31.79|-18.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-18.59|-31.79|<0.001
74038715|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.25|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-48.77|-37.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.74|-48.77|<0.001
74038716|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.33|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-51.04|-39.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.61|-51.04|<0.001
74038717|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.13|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-46.65|-35.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.61|-46.65|<0.001
73878435|NCT05552027|147296299|SUPERIORITY||||||<|0.001||||||At the completion of scenario A (a full child safety seat installation), the participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.001
74006543|NCT03027557|147562858|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
74006544|NCT03027557|147562859|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
74006545|NCT03027557|147562860|SUPERIORITY||||||=|0.0019|||||||ANOVA|||||||= 0.0019
74006546|NCT03027557|147562861|SUPERIORITY||||||=|0.096|||||||ANOVA|||||||= 0.096
74091172|NCT00359788|147736096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.14||||0.4388||95.0|-6.372|14.651|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.651|-6.372|0.4388
74091173|NCT00359788|147736097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.185||||0.8288||95.0|-9.595|11.964|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||11.964|-9.595|0.8288
74091174|NCT00359788|147736098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.204||||0.4929||95.0|-7.857|16.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||16.264|-7.857|0.4929
74091175|NCT00359788|147736099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204||||0.0754||95.0|-0.021|0.429|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.429|-0.021|0.0754
74091176|NCT00359788|147736100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251||||0.0765||95.0|-0.027|0.528|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.528|-0.027|0.0765
74091177|NCT00359788|147736101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151||||0.163||95.0|-0.061|0.363|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.363|-0.061|0.163
73878436|NCT05552027|147296299|SUPERIORITY||||||<|0.01||||||At the end of scenario B (loose harness straps), participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.01
74006547|NCT03027557|147562862|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
74006548|NCT03027557|147562863|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
74006549|NCT03027557|147562864|SUPERIORITY||||||=|0.0027|||||||ANOVA|||||||= 0.0027
73878437|NCT05552027|147296299|SUPERIORITY||||||<|0.01||||||At the end of scenario C (loose attachment at the base), like the other two scenarios, participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.01
73878438|NCT02653326|147296303|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
73878439|NCT02653326|147296304|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.32
74006550|NCT03027557|147562865|SUPERIORITY||||||=|0.081|||||||ANOVA|||||||= 0.081
74006551|NCT03027557|147562866|SUPERIORITY||||||=|0.0071|||||||ANOVA|||||||= 0.0071
74006552|NCT03027557|147562867|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
74006553|NCT03027557|147562868|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
74006554|NCT03027557|147562869|SUPERIORITY||||||=|0.38|||||||Kruskal-Wallis|||||||= 0.38
74006555|NCT03027557|147562874|SUPERIORITY||||||=|0.83|||||||Kruskal-Wallis|||||||= 0.83
74006556|NCT03027557|147562877|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
74006557|NCT03027557|147562878|SUPERIORITY||||||=|0.0077|||||||ANOVA|||||||= 0.0077
74006558|NCT03027557|147562879|SUPERIORITY||||||=|0.011|||||||ANOVA|||||||= 0.011
74006559|NCT03027557|147562880|SUPERIORITY||||||=|0.011|||||||ANOVA|||||||= 0.011
74006560|NCT03027557|147562881|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
74006561|NCT03027557|147562882|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
74006562|NCT03027557|147562883|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
74006563|NCT03027557|147562884|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
74006564|NCT03027557|147562885|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
74006565|NCT03027557|147562887|SUPERIORITY||||||=|0.5|||||||Kruskal-Wallis|||||||= 0.5
74006566|NCT03027557|147562888|SUPERIORITY||||||=|0.85|||||||ANOVA|||||||= 0.85
74006567|NCT03027557|147562889|SUPERIORITY||||||=|0.22|||||||ANOVA|||||||= 0.22
74006568|NCT03027557|147562890|SUPERIORITY||||||=|0.18|||||||Kruskal-Wallis|||||||= 0.18
74006569|NCT04721821|147562893|SUPERIORITY||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.82|1.44||||||||1.44|0.82|
74006570|NCT04721821|147562894|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.44|1.16||||||||1.16|0.44|
74006571|NCT04721821|147562895|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.73|1.27||||||||1.27|0.73|
74006572|NCT04721821|147562896|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.79|1.88||||||||1.88|0.79|
74006573|NCT04721821|147562897|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.79|1.67||||||||1.67|0.79|
74006574|NCT04721821|147562898|SUPERIORITY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.94|1.76||||||||1.76|0.94|
74091178|NCT00359788|147736102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.285||||0.0085||95.0|0.073|0.496|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.496|0.073|0.0085
74091179|NCT04932941|147736113|SUPERIORITY||Common risk difference|-0.276||||0.962|TWO_SIDED|95.0|-11.634|11.081|||Mantel Haenszel||Strata-adjusted Mantel Haenszel (MH) method for difference in proportions controlling for stratification factors (COVID-19 severity: moderate, severe, and age group: less than or equal to 65 years, greater than 65 years).|||11.081|-11.634|0.962
74091180|NCT01366443|147736138|SUPERIORITY_OR_OTHER||Sensitivity|0.85|||||TWO_SIDED|95.0|0.79|0.89|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.||0.89|0.79|
74091181|NCT01366443|147736138|SUPERIORITY_OR_OTHER||Specificity|0.98|||||TWO_SIDED|95.0|0.93|0.99|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.||0.99|0.93|
74006575|NCT04721821|147562899|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.7|1.89||||||||1.89|0.70|
74006576|NCT04721821|147562900|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.69|1.32||||||||1.32|0.69|
74006577|NCT04721821|147562901|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.81|2.16||||||||2.16|0.81|
73878440|NCT04621448|147296371|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.048|TWO_SIDED|95.0|0.01|4.39|||Mixed Models Analysis||The mean difference estimate of 2.2 was confirmed. It is slightly different than the difference of the raw change values \[+.7 - (-1.7) = 2.4\] because it comes from the mixed effects model.|||4.39|0.01|0.048
73878441|NCT04621448|147296372|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.603|TWO_SIDED|95.0|-4.12|2.4|||Mixed Models Analysis|||||2.40|-4.12|0.603
73957322|NCT01280591|147450746|SUPERIORITY_OR_OTHER|||||||0.0321|||||||Cochran-Mantel-Haenszel|||||||0.0321
73957323|NCT01280591|147450747|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Cochran-Mantel-Haenszel|||||||0.0019
73957324|NCT01280591|147450748|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73957325|NCT01280591|147450749|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
73957326|NCT01280591|147450750|SUPERIORITY_OR_OTHER|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
73957327|NCT01280591|147450751|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73957328|NCT01280591|147450752|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73957329|NCT01280591|147450753|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Cochran-Mantel-Haenszel|||||||0.0016
73957330|NCT01280591|147450754|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
73957331|NCT01280591|147450755|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73957332|NCT01280591|147450756|SUPERIORITY_OR_OTHER|||||||0.0064|||||||ANCOVA|||||||0.0064
73957333|NCT01280591|147450757|SUPERIORITY_OR_OTHER|||||||0.0047|||||||Cochran-Mantel-Haenszel|||||||0.0047
73957334|NCT01280591|147450758|SUPERIORITY_OR_OTHER|||||||0.0053|||||||Log Rank|||||||0.0053
73957335|NCT01280591|147450760|SUPERIORITY_OR_OTHER|||||||0.2734|||||||Cochran-Mantel-Haenszel|||||||0.2734
73957336|NCT02228408|147450810|SUPERIORITY|||||||0.04|||||||poisson|||||||0.04
73957337|NCT02228408|147450811|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
73957338|NCT02228408|147450812|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
73957339|NCT02228408|147450816|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
73957340|NCT03670602|147450833|SUPERIORITY|||||||0.0035||||||This is for the treatment group x time effect, or if treatment influenced improvements in delay discounting across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Treatment group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate.||||0.0035
73957341|NCT03670602|147450833|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if delay discounting improved across all three timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Treatment group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
73957342|NCT03670602|147450834|SUPERIORITY|||||||0.85||||||This is for the treatment group x time effect, or if treatment differentially influenced weight across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.85
73957343|NCT03670602|147450834|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if time influenced changes in weight, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
73957344|NCT03670602|147450835|SUPERIORITY|||||||0.79||||||This is for the treatment group x time effect, or if treatment group influenced change in hBa1c across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.79
73957345|NCT03670602|147450835|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if hBa1c changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
73957346|NCT03670602|147450836|SUPERIORITY|||||||0.201||||||This is for the treatment group x time effect, or if treatment differentially influenced medication adherence across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.201
73957347|NCT03670602|147450836|SUPERIORITY|||||||0.315||||||This is for the time effect, or if timepoint influenced medication adherence across all timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.315
74006578|NCT04721821|147562902|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.81|1.87||||||||1.87|0.81|
74006579|NCT04721821|147562903|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.8|1.66||||||Month 6 follow-up visit analysis||1.66|0.80|
74006580|NCT04721821|147562903|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||Month 12 follow-up visit analysis||1.65|0.75|
74006581|NCT04721821|147562904|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.57|1.99||||||Month 6 follow-up visit analysis||1.99|0.57|
74006582|NCT04721821|147562904|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.49|1.75||||||Month 12 follow-up visit analysis||1.75|0.49|
74006583|NCT04721821|147562905|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.79|1.58||||||Month 6 follow-up visit analysis||1.58|0.79|
74006584|NCT04721821|147562905|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.6|1.35||||||Month 12 follow-up visit analysis||1.35|0.60|
74006585|NCT04721821|147562906|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.77|2.29||||||Month 6 follow-up visit analysis||2.29|0.77|
74006586|NCT04721821|147562906|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.82|2.71||||||Month 12 follow-up visit analysis||2.71|0.82|
74006587|NCT04721821|147562907|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|0.81|2.24||||||Month 6 follow-up visit analysis||2.24|0.81|
74006588|NCT04721821|147562907|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.62||||||Month 12 follow-up visit analysis||1.62|0.50|
74006589|NCT04721821|147562908|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.88|1.31||||||Month 6 follow-up visit analysis||1.31|-0.88|
73878442|NCT04621448|147296373|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.734|TWO_SIDED|95.0|-2.75|3.92|||Mixed Models Analysis|||||3.92|-2.75|0.734
74038718|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.99|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-41.72|-28.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.25|-41.72|<0.001
73878443|NCT04621448|147296374|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.159|TWO_SIDED|95.0|-0.62|3.74|||Mixed Models Analysis|||||3.74|-0.62|0.159
73878444|NCT04621448|147296375|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.818|TWO_SIDED|95.0|-1.97|1.56|||Mixed Models Analysis|||||1.56|-1.97|0.818
74006590|NCT04721821|147562908|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.73|-0.27||||||Month 12 follow-up visit analysis||-0.27|-2.73|
74006591|NCT04721821|147562909|SUPERIORITY||Median Difference (Net)|0.39|||||TWO_SIDED|95.0|-1.24|2.02||||||Month 6 follow-up visit analysis||2.02|-1.24|
74006592|NCT04721821|147562909|SUPERIORITY||Median Difference (Net)|0.96|||||TWO_SIDED|95.0|-0.92|2.84||||||Month 12 follow-up visit analysis||2.84|-0.92|
74006593|NCT04721821|147562910|SUPERIORITY||Mean Difference (Net)|-0.56|||||TWO_SIDED|95.0|-1.68|0.56||||||Month 6 follow-up visit analysis||0.56|-1.68|
74006594|NCT04721821|147562910|SUPERIORITY||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|-0.51|1.99||||||Month 12 follow-up visit analysis||1.99|-0.51|
74006595|NCT04721821|147562911|SUPERIORITY||Mean Difference (Net)|-1.11|||||TWO_SIDED|95.0|-2.66|0.45||||||Month 6 follow-up visit analysis||0.45|-2.66|
74006596|NCT04721821|147562911|SUPERIORITY||Mean Difference (Net)|-1.73|||||TWO_SIDED|95.0|-3.52|0.05||||||Month 12 follow-up visit analysis||0.05|-3.52|
74006597|NCT04721821|147562912|SUPERIORITY||Mean Difference (Net)|-0.93|||||TWO_SIDED|95.0|-2.3|0.44||||||Month 6 follow-up visit analysis||0.44|-2.30|
74006598|NCT04721821|147562912|SUPERIORITY||Mean Difference (Net)|-0.99|||||TWO_SIDED|95.0|-2.6|0.62||||||Month 12 follow-up visit analysis||0.62|-2.60|
74006599|NCT04721821|147562913|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.8|1.35||||||Month 6 follow-up visit analysis: mACR 20||1.35|0.80|
74006600|NCT04721821|147562913|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.86|1.67||||||Month 6 follow-up visit analysis: mACR 50||1.67|0.86|
74006601|NCT04721821|147562913|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.57|1.54||||||Month 6 follow-up visit analysis: mACR 70||1.54|0.57|
74006602|NCT04721821|147562913|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.41||||||Month 12 follow-up visit analysis: mACR 20||1.41|0.77|
74006603|NCT04721821|147562913|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.89|1.95||||||Month 12 follow-up visit analysis: mACR 50||1.95|0.89|
74006604|NCT04721821|147562913|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.85|2.6||||||Month 12 follow-up visit analysis: mACR 70||2.60|0.85|
74006605|NCT04721821|147562914|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.59|1.34||||||Month 6 follow-up visit analysis: mACR 20||1.34|0.59|
74006606|NCT04721821|147562914|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.39|1.15||||||Month 6 follow-up visit analysis: mACR 50||1.15|0.39|
74006607|NCT04721821|147562914|SUPERIORITY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.34|1.83||||||Month 6 follow-up visit analysis: mACR 70||1.83|0.34|
74006608|NCT04721821|147562914|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.56|1.42||||||Month 12 follow-up visit analysis: mACR 20||1.42|0.56|
74006609|NCT04721821|147562914|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.46|1.8||||||Month 12 follow-up visit analysis: mACR 50||1.80|0.46|
74006610|NCT04721821|147562914|SUPERIORITY||Odds Ratio (OR)|0.54|||||TWO_SIDED|95.0|0.19|1.48||||||Month 12 follow-up visit analysis: mACR 70||1.48|0.19|
74006611|NCT04721821|147562915|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.86|1.45||||||Month 6 follow-up visit analysis: mACR 20||1.45|0.86|
74006612|NCT04721821|147562915|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.67|1.26||||||Month 6 follow-up visit analysis: mACR 50||1.26|0.67|
74006613|NCT04721821|147562915|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.44|1.09||||||Month 6 follow-up visit analysis: mACR 70||1.09|0.44|
74006614|NCT04721821|147562915|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.74|1.38||||||Month 12 follow-up visit analysis: mACR 20||1.38|0.74|
73878445|NCT04621448|147296376|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.089|TWO_SIDED|95.0|-0.26|3.51|||Mixed Models Analysis|||||3.51|-0.26|0.089
74006615|NCT04721821|147562915|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.69|1.52||||||Month 12 follow-up visit analysis: mACR 50||1.52|0.69|
74006616|NCT04721821|147562915|SUPERIORITY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.46|1.33||||||Month 12 follow-up visit analysis: mACR 70||1.33|0.46|
74006617|NCT04721821|147562916|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.78|1.77||||||Month 6 follow-up visit analysis: mACR 20||1.77|0.78|
74038719|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.04|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-51.83|-42.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.25|-51.83|<0.001
74038720|NCT01763866|147630761|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.6|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|-50.67|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-38.54|-50.67|<0.001
74038721|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.97|STANDARD_ERROR_OF_MEAN|2.51|<|0.001|TWO_SIDED|95.0|-64.91|-55.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.03|-64.91|<0.001
74038722|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.11|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-59.57|-48.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.64|-59.57|<0.001
74038723|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-42.8|-32.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.77|-42.80|<0.001
74038724|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.86|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-47.34|-36.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.67|-47.34|<0.001
73878446|NCT04621448|147296377|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.631|TWO_SIDED|95.0|-0.96|1.58|||Mixed Models Analysis|||||1.58|-0.96|0.631
73878447|NCT04621448|147296378|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.484|TWO_SIDED|95.0|-0.71|1.49|||Mixed Models Analysis|||||1.49|-0.71|0.484
74038725|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.9|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-64.22|-49.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.59|-64.22|<0.001
73878448|NCT04621448|147296379|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.81|TWO_SIDED|95.0|-2.36|3.01|||Mixed Models Analysis|||||3.01|-2.36|0.81
74038726|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.99|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-68.68|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.29|-68.68|<0.001
74038727|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.26|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-44.48|-30.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.04|-44.48|<0.001
73878449|NCT04621448|147296380|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.384|TWO_SIDED|95.0|-0.77|2.0|||Mixed Models Analysis|||||2.00|-0.77|0.384
73878450|NCT04621448|147296381|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.509|TWO_SIDED|95.0|-1.65|0.81|||Mixed Models Analysis|||||0.81|-1.65|0.509
74006618|NCT04721821|147562916|SUPERIORITY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.71|1.95||||||Month 6 follow-up visit analysis: mACR 50||1.95|0.71|
74006619|NCT04721821|147562916|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.45|2.39||||||Month 6 follow-up visit analysis: mACR 70||2.39|0.45|
74006620|NCT04721821|147562916|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.5|1.4||||||Month 12 follow-up visit analysis: mACR 20||1.40|0.50|
74006621|NCT04721821|147562916|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.49|1.83||||||Month 12 follow-up visit analysis: mACR 50||1.83|0.49|
74006622|NCT04721821|147562916|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.33|1.95||||||Month 12 follow-up visit analysis: mACR 70||1.95|0.33|
74006623|NCT04721821|147562917|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.76|1.49||||||Month 6 follow-up visit analysis: mACR 20||1.49|0.76|
74038728|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.29|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-50.07|-36.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.51|-50.07|<0.001
74038729|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.29|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-60.79|-49.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.79|-60.79|<0.001
74091182|NCT01366443|147736138|SUPERIORITY_OR_OTHER||Positive Predictive Value|0.99|||||TWO_SIDED|95.0|0.96|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.||1.00|0.96|
74006624|NCT04721821|147562917|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.37||||||Month 6 follow-up visit analysis: mACR 50||1.37|0.55|
74006625|NCT04721821|147562917|SUPERIORITY||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.32|1.2||||||Month 6 follow-up visit analysis: mACR 70||1.20|0.32|
74006626|NCT04721821|147562917|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.59|1.3||||||Month 12 follow-up visit analysis: mACR 20||1.30|0.59|
74006627|NCT04721821|147562917|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.65|1.86||||||Month 12 follow-up visit analysis: mACR 50||1.86|0.65|
74006628|NCT04721821|147562917|SUPERIORITY||Odds Ratio (OR)|1.43||||||95.0|0.62|3.28||||||Month 12 follow-up visit analysis: mACR 70||3.28|0.62|
74006629|NCT04721821|147562918|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.94|2.15||||||Month 6 follow-up visit analysis||2.15|0.94|
74006630|NCT04721821|147562918|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.68|1.84||||||Month 12 follow-up visit analysis||1.84|0.68|
74006631|NCT04721821|147562919|SUPERIORITY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.41|1.67||||||Month 6 follow-up visit analysis||1.67|0.41|
74006632|NCT04721821|147562919|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.62|3.07||||||Month 12 follow-up visit analysis||3.07|0.62|
74006633|NCT04721821|147562920|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||Month 6 follow-up visit analysis||1.52|0.66|
74006634|NCT04721821|147562920|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.64|1.74||||||Month 12 follow-up visit analysis||1.74|0.64|
74006635|NCT04721821|147562921|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.8|2.94||||||Month 6 follow-up visit analysis||2.94|0.80|
74006636|NCT04721821|147562921|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|0.76|3.87||||||Month 12 follow-up visit analysis||3.87|0.76|
74006637|NCT04721821|147562922|SUPERIORITY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.73|2.27||||||Month 6 follow-up visit analysis||2.27|0.73|
74006638|NCT04721821|147562922|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.63|2.23||||||Month 12 follow-up visit analysis||2.23|0.63|
74006639|NCT04721821|147562923|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||||||Month 6 follow-up visit analysis||0.04|-0.06|
74006640|NCT04721821|147562923|SUPERIORITY||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.01|0.09||||||Month 12 follow-up visit analysis||0.09|-0.01|
74006641|NCT04721821|147562924|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.08|0.06||||||Month 6 follow-up visit analysis||0.06|-0.08|
74006642|NCT04721821|147562924|SUPERIORITY||Median Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.11|0.05||||||Month 12 follow-up visit analysis||0.05|-0.11|
74006643|NCT04721821|147562925|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.07|0.03||||||Month 6 follow-up visit analysis||0.03|-0.07|
74006644|NCT04721821|147562925|SUPERIORITY||Odds Ratio (OR)|0.01|||||TWO_SIDED|95.0|-0.05|0.07||||||Month 12 follow-up visit analysis||0.07|-0.05|
74006645|NCT04721821|147562926|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.07||||||Month 6 follow-up visit analysis||0.07|-0.06|
74006646|NCT04721821|147562926|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.12|0.06||||||Month 12 follow-up visit analysis||0.06|-0.12|
74006647|NCT04721821|147562927|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.09|0.04||||||Month 6 follow-up visit analysis||0.04|-0.09|
74006648|NCT04721821|147562927|SUPERIORITY||Odds Ratio (OR)|0.02|||||TWO_SIDED|95.0|-0.06|0.09||||||Month 12 follow-up visit analysis||0.09|-0.06|
74006649|NCT04721821|147562928|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.9|1.45||||||Month 6 follow-up visit analysis||1.45|0.90|
74006650|NCT04721821|147562928|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.54|0.94||||||Month 12 follow-up visit analysis||0.94|0.54|
74006651|NCT04721821|147562929|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.53|1.11||||||Month 6 follow-up visit analysis||1.11|0.53|
74006652|NCT04721821|147562929|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.72|1.61||||||Month 12 follow-up visit analysis||1.61|0.72|
74006653|NCT04721821|147562930|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.73|1.21||||||Month 6 follow-up visit analysis||1.21|0.73|
74006654|NCT04721821|147562930|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.39||||||Month 12 follow-up visit analysis||1.39|0.77|
74006655|NCT04721821|147562931|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.64|1.32||||||Month 6 follow-up visit analysis||1.32|0.64|
74006656|NCT04721821|147562931|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.69|1.64||||||Month 12 follow-up visit analysis||1.64|0.69|
74006657|NCT04721821|147562932|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.84|1.59||||||Month 6 follow-up visit analysis||1.59|0.84|
74006658|NCT04721821|147562932|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.65|1.32||||||Month 12 follow-up visit analysis||1.32|0.65|
74006659|NCT04721821|147562933|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.03|0.04||||||Month 6 follow-up visit analysis||0.04|-0.03|
74006660|NCT04721821|147562933|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.04|0.05||||||Month 12 follow-up visit analysis||0.05|-0.04|
74006661|NCT04721821|147562934|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.05|0.05||||||Month 6 follow-up visit analysis||0.05|-0.05|
74006662|NCT04721821|147562934|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.07|0.06||||||Month 12 follow-up visit analysis||0.06|-0.07|
74006663|NCT04721821|147562935|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.02||||||Month 6 follow-up visit analysis||0.02|-0.06|
74006664|NCT04721821|147562935|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||Month 12 follow-up visit analysis||0.04|-0.04|
74006665|NCT04721821|147562936|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||||||Month 6 follow-up visit analysis||0.04|-0.06|
74038730|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.24|STANDARD_ERROR_OF_MEAN|2.49|<|0.001|TWO_SIDED|95.0|-64.16|-54.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.32|-64.16|<0.001
74038731|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.63|STANDARD_ERROR_OF_MEAN|3.13|<|0.001|TWO_SIDED|95.0|-56.82|-44.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.45|-56.82|<0.001
74038732|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.78|STANDARD_ERROR_OF_MEAN|3.61|<|0.001|TWO_SIDED|95.0|-63.91|-49.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.64|-63.91|<0.001
74038733|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.75|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-62.51|-52.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.99|-62.51|<0.001
74038734|NCT01763866|147630762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.06|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-61.85|-50.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-50.27|-61.85|<0.001
74038735|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.29|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-65.65|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.94|-65.65|<0.001
74038736|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.44|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-54.23|-42.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.65|-54.23|<0.001
74038737|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.66|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-45.09|-34.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.23|-45.09|<0.001
74038738|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.32|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-43.12|-31.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.52|-43.12|<0.001
74091183|NCT01366443|147736138|SUPERIORITY_OR_OTHER||Negative Predictive Value|0.77|||||TWO_SIDED|95.0|0.69|0.84|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.||0.84|0.69|
74091184|NCT01366443|147736138|SUPERIORITY_OR_OTHER||Sensitivity|0.99|||||TWO_SIDED|95.0|0.97|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.||1.00|0.97|
74091185|NCT01366443|147736138|SUPERIORITY_OR_OTHER||Specificity|0.91|||||TWO_SIDED|95.0|0.83|0.95|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.||0.95|0.83|
74091186|NCT01366443|147736138|SUPERIORITY_OR_OTHER||Positive Predictive Value|0.95|||||TWO_SIDED|95.0|0.9|0.98|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.||0.98|0.90|
74038739|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.77|STANDARD_ERROR_OF_MEAN|3.95|<|0.001|TWO_SIDED|95.0|-65.55|-49.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.99|-65.55|<0.001
74038740|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.26|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-64.91|-49.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.60|-64.91|<0.001
74038741|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.9|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-47.53|-32.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.26|-47.53|<0.001
73878451|NCT04621448|147296382|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.021|TWO_SIDED|95.0|0.24|3.01|||Mixed Models Analysis|||||3.01|0.24|0.021
73878452|NCT04621448|147296383|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.156|TWO_SIDED|95.0|-1.94|0.31|||Mixed Models Analysis|||||0.31|-1.94|0.156
73878453|NCT04621448|147296384|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.582|TWO_SIDED|95.0|-0.62|1.1|||Mixed Models Analysis|||||1.10|-0.62|0.582
73878454|NCT04621448|147296385|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.271|TWO_SIDED|95.0|-1.21|0.34|||Mixed Models Analysis|||||0.34|-1.21|0.271
74038742|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.57|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-46.26|-30.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.88|-46.26|<0.001
74006666|NCT04721821|147562936|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.1|0.03||||||Month 12 follow-up visit analysis||0.03|-0.10|
74006667|NCT04721821|147562937|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.05|0.04||||||Month 6 follow-up visit analysis||0.04|-0.05|
74006668|NCT04721821|147562937|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.06||||||Month 12 follow-up visit analysis||0.06|-0.06|
74006669|NCT04721821|147562938|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.65|2.45||||||Month 6 follow-up visit analysis||2.45|-2.65|
74006670|NCT04721821|147562938|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-2.59|3.11||||||Month 12 follow-up visit analysis||3.11|-2.59|
74006671|NCT04721821|147562939|SUPERIORITY||Mean Difference (Final Values)|0.83|||||TWO_SIDED|95.0|-2.71|4.38||||||Month 6 follow-up visit analysis||4.38|-2.71|
74006672|NCT04721821|147562939|SUPERIORITY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|95.0|-5.12|2.95||||||Month 12 follow-up visit analysis||2.95|-5.12|
74006673|NCT04721821|147562940|SUPERIORITY||Mean Difference (Final Values)|-1.25|||||TWO_SIDED|95.0|-3.94|1.45||||||Month 6 follow-up visit analysis||1.45|-3.94|
74006674|NCT04721821|147562940|SUPERIORITY||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-3.61|2.42||||||Month 12 follow-up visit analysis||2.42|-3.61|
73878455|NCT04621448|147296386|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.834|TWO_SIDED|95.0|-1.52|1.88|||Mixed Models Analysis|||||1.88|-1.52|0.834
73878456|NCT04621448|147296387|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.529|TWO_SIDED|95.0|-1.62|3.15|||Mixed Models Analysis|||||3.15|-1.62|0.529
73878457|NCT04621448|147296388|SUPERIORITY|||||||0.377|||||||Poisson regression|||||||0.377
73878458|NCT04621448|147296389|SUPERIORITY|||||||0.043|||||||Poisson regression|||||||0.043
73878459|NCT03550378|147296390|SUPERIORITY||LS Mean Difference|-30.384|||<|0.001|TWO_SIDED|90.0|-41.27|-19.498|||ANCOVA|||||-19.498|-41.270|<0.001
73878460|NCT03071263|147296466|SUPERIORITY||||||<|0.0001||||||α-level 0.05. Stratified by baseline potassium category (4.3-\<4.7 mEq/L or 4.7-5.1 mEq/L) and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as randomized|Cochran-Mantel-Haenszel|||A sample size of 280 subjects has 90% power to detect a difference between treatment groups of 20% or more in the proportion of subjects remaining on spironolactone at Week 12, at α = 0.05.||||<0.0001
73878461|NCT03071263|147296467|SUPERIORITY|||||||0.5757||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-\<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as factors in the model.|ANCOVA|||||||0.5757
73878462|NCT03071263|147296468|SUPERIORITY|||||||0.6367||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-\<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus as factors in the model.|ANCOVA|||The p-value is from a test comparing the difference between two groups in the mean change in AOBP SBP from baseline.||||0.6367
74006675|NCT04721821|147562941|SUPERIORITY||Mean Difference (Final Values)|-0.67|||||TWO_SIDED|95.0|-4.39|3.05||||||Month 6 follow-up visit analysis||3.05|-4.39|
74006676|NCT04721821|147562941|SUPERIORITY||Mean Difference (Final Values)|-4.84|||||TWO_SIDED|95.0|-9.19|-0.48||||||Month 12 follow-up visit analysis||-0.48|-9.19|
74006677|NCT04721821|147562942|SUPERIORITY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-3.59|2.82||||||Month 6 follow-up visit analysis||2.82|-3.59|
74006678|NCT04721821|147562942|SUPERIORITY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-2.97|4.49||||||Month 12 follow-up visit analysis||4.49|-2.97|
74006679|NCT04721821|147562943|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.73|1.34||||||Month 6 follow-up visit analysis||1.34|0.73|
74006680|NCT04721821|147562943|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.66|1.34||||||Month 12 follow-up visit analysis||1.34|0.66|
74006681|NCT04721821|147562944|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.62|1.73||||||Month 6 follow-up visit analysis||1.73|0.62|
74006682|NCT04721821|147562944|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.6||||||Month 12 follow-up visit analysis||1.60|0.50|
74006683|NCT04721821|147562945|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.64|1.19||||||Month 6 follow-up visit analysis||1.19|0.64|
74006684|NCT04721821|147562945|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.6|1.26||||||Month 12 follow-up visit analysis||1.26|0.60|
74006685|NCT04721821|147562946|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.55|1.46||||||Month 6 follow-up visit analysis||1.46|0.55|
74006686|NCT04721821|147562946|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.47|1.51||||||Month 12 follow-up visit analysis||1.51|0.47|
74006687|NCT04721821|147562947|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.6|1.38||||||Month 6 follow-up visit analysis||1.38|0.60|
74006688|NCT04721821|147562947|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.56|1.5||||||Month 12 follow-up visit analysis||1.50|0.56|
74006689|NCT04721821|147562948|SUPERIORITY||Mean Difference (Final Values)|1.71|||||TWO_SIDED|95.0|-0.69|4.11||||||Month 6 follow-up visit analysis||4.11|-0.69|
74006690|NCT04721821|147562948|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-2.79|2.77||||||Month 12 follow-up visit analysis||2.77|-2.79|
74006691|NCT04721821|147562949|SUPERIORITY||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-5.02|1.6||||||Month 6 follow-up visit analysis||1.60|-5.02|
74006692|NCT04721821|147562949|SUPERIORITY||Mean Difference (Final Values)|1.06|||||TWO_SIDED|95.0|-2.85|4.96||||||Month 12 follow-up visit analysis||4.96|-2.85|
74006693|NCT04721821|147562950|SUPERIORITY||Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-3.75|1.45||||||Month 6 follow-up visit analysis||1.45|-3.75|
74006694|NCT04721821|147562950|SUPERIORITY||Median Difference (Final Values)|-0.53|||||TWO_SIDED|95.0|-3.54|2.47||||||Month 12 follow-up visit analysis||2.47|-3.54|
74006695|NCT04721821|147562951|SUPERIORITY||Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|-2.36|4.73||||||Month 6 follow-up visit analysis||4.73|-2.36|
74006696|NCT04721821|147562951|SUPERIORITY||Mean Difference (Final Values)|-3.15|||||TWO_SIDED|95.0|-7.36|1.07||||||Month 12 follow-up visit analysis||1.07|-7.36|
74006697|NCT04721821|147562952|SUPERIORITY||Mean Difference (Final Values)|2.37|||||TWO_SIDED|95.0|-0.66|5.41||||||Month 6 follow-up visit analysis||5.41|-0.66|
74006698|NCT04721821|147562952|SUPERIORITY||Mean Difference (Final Values)|1.01|||||TWO_SIDED|95.0|-2.69|4.71||||||Month 12 follow-up visit analysis||4.71|-2.69|
74006699|NCT04721821|147562953|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.16|0.4||||||Month 6 follow-up visit analysis||0.40|-0.16|
74006700|NCT04721821|147562953|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.21|0.45||||||Month 12 follow-up visit analysis||0.45|-0.21|
74006701|NCT04721821|147562954|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.4|0.43||||||Month 6 follow-up visit analysis||0.43|-0.40|
74006702|NCT04721821|147562954|SUPERIORITY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.74|0.29||||||Month 12 follow-up visit analysis||0.29|-0.74|
74006703|NCT04721821|147562955|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.51|0.1||||||Month 6 follow-up visit analysis||0.10|-0.51|
74006704|NCT04721821|147562955|SUPERIORITY||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.42|0.31||||||Month 12 follow-up visit analysis||0.31|-0.42|
74006705|NCT04721821|147562956|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.34|0.32||||||Month 6 follow-up visit analysis||0.32|-0.34|
74006706|NCT04721821|147562956|SUPERIORITY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.69|0.31||||||Month 12 follow-up visit analysis||0.31|-0.69|
74038743|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.41|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-59.99|-48.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.82|-59.99|<0.001
74038744|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.13|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-61.58|-50.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.68|-61.58|<0.001
74038745|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.17|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-55.8|-42.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.53|-55.80|<0.001
74006707|NCT04721821|147562957|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.37|0.32||||||Month 6 follow-up visit analysis||0.32|-0.37|
74006708|NCT04721821|147562957|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.3|0.59||||||Month 12 follow-up visit analysis||0.59|-0.30|
74006709|NCT03836807|147562966|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.020
74006710|NCT03836807|147562967|SUPERIORITY|||||||0.026|||||||ANOVA|||||||0.026
74006711|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-0.3||||0.914|TWO_SIDED|95.0|-5.5|5.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at Baseline (at 0')||5.0|-5.5|0.914
74006712|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|1.3||||0.685|TWO_SIDED|95.0|-4.9|7.4|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||7.4|-4.9|0.685
74006713|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-0.3||||0.93|TWO_SIDED|95.0|-7.4|6.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 10'||6.8|-7.4|0.930
74006714|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-2.1||||0.615|TWO_SIDED|95.0|-10.3|6.1|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 15'||6.1|-10.3|0.615
74006715|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-8.5||||0.051|TWO_SIDED|95.0|-17.0|0.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 30'||0|-17.0|0.051
74006716|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-8.4||||0.043|TWO_SIDED|95.0|-16.6|-0.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 45'||-0.3|-16.6|0.043
74006717|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-9.0||||0.023|TWO_SIDED|95.0|-16.7|-1.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1h||-1.3|-16.7|0.023
74006718|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-10.5||||0.009|TWO_SIDED|95.0|-18.2|-2.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1.5h||-2.7|-18.2|0.009
74006719|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-9.3||||0.018|TWO_SIDED|95.0|-17.0|-1.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 2h||-1.7|-17.0|0.018
74006720|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-5.5||||0.182|TWO_SIDED|95.0|-13.6|2.6|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 3h||2.6|-13.6|0.182
74006721|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-4.8||||0.236|TWO_SIDED|95.0|-12.9|3.2|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 4h||3.2|-12.9|0.236
74006722|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-3.6||||0.32|TWO_SIDED|95.0|-10.6|3.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5h||3.5|-10.6|0.320
74006723|NCT03836807|147562968|SUPERIORITY||adjusted least square mean|-2.2||||0.572|TWO_SIDED|95.0|-10.0|5.6|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 6h||5.6|-10.0|0.572
74006724|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|2.7||||0.361|TWO_SIDED|95.0|-3.1|8.4|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||8.4|-3.1|0.361
74006725|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|4.2||||0.298|TWO_SIDED|95.0|-3.8|12.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 10'||12.3|-3.8|0.298
74006726|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|8.9||||0.112|TWO_SIDED|95.0|-2.1|19.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 15'||19.8|-2.1|0.112
74006727|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|22.3||||0.003|TWO_SIDED|95.0|7.8|36.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 30'||36.8|7.8|0.003
74006728|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|21.2||||0.008|TWO_SIDED|95.0|5.6|36.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 45'||36.7|5.6|0.008
74006729|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|18.7||||0.018|TWO_SIDED|95.0|3.3|34.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1h||34.0|3.3|0.018
74006730|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|22.3||||0.003|TWO_SIDED|95.0|7.7|37.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1.5h||37.0|7.7|0.003
74006731|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|22.0||||0.003|TWO_SIDED|95.0|8.0|36.1|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 2h||36.1|8.0|0.003
74006732|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|16.7||||0.015|TWO_SIDED|95.0|3.4|30.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 3h||30.0|3.4|0.015
74006733|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|10.8||||0.103|TWO_SIDED|95.0|-2.2|23.9|||ANOVA|||at 4h||23.9|-2.2|0.103
74006734|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|5.9||||0.311|TWO_SIDED|95.0|-5.6|17.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||17.5|-5.6|0.311
74006735|NCT03836807|147562969|SUPERIORITY||adjusted least square mean|2.8||||0.638|TWO_SIDED|95.0|-9.0|14.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 6h||14.5|-9.0|0.638
74006736|NCT03836807|147562970|SUPERIORITY|||||||0.007|||||||ANOVA|||in the ITT population||||0.007
74006737|NCT03836807|147562970|SUPERIORITY|||||||0.009|||||||ANOVA|||in the PP population||||0.009
74038746|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.81|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-57.21|-40.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.40|-57.21|<0.001
74006738|NCT03836807|147562971|SUPERIORITY|||||||0.004|||||||Log Rank|||||||0.004
74006739|NCT03836807|147562972|SUPERIORITY|||||||0.002|||||||Log Rank|||||||0.002
74006740|NCT03836807|147562973|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.480
74006741|NCT02430051|147562974|SUPERIORITY|||||||0.01|||||||Mixed-effects regression model|Adjusted for attained age and first or second clinic visit.||||||0.01
74006742|NCT02430051|147562975|SUPERIORITY|||||||0.25|||||||Mixed-effects regression model|Adjustment for attained age and first and second clinic visit.||||||0.25
74006743|NCT02430051|147562976|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
74006744|NCT02430051|147562977|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74006745|NCT02430051|147562978|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74006746|NCT02430051|147562979|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74006747|NCT02430051|147562980|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74006748|NCT02430051|147562981|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
74006749|NCT02430051|147562982|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
74006750|NCT02430051|147562983|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
74006751|NCT02430051|147562984|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
74006752|NCT02430051|147562985|SUPERIORITY||||||<|0.0001|||||||Multivariate linear regression|Adjusted for autism severity, IQ, dental fear and anxiety, sensory over-responsivity, general anxiety, expressive communication, gender, and age.||||||<0.0001
74006753|NCT02430051|147562986|SUPERIORITY|||||||0.61|||||||General linear mixed model|||||||0.61
74006754|NCT02019420|147562997|NON_INFERIORITY|Difference in ITT all-cause mortality (linezolid - tedizolid). Noninferiority is declared when the lower bound of the 95% CI \> -10.|Difference in all-cause mortality|-1.8|||||TWO_SIDED|95.0|-8.2|4.7|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||4.7|-8.2|
74006755|NCT02019420|147562998|OTHER|Difference in mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.6|||||TWO_SIDED|95.0|-10.3|7.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||7.1|-10.3|
74006756|NCT02019420|147562999|OTHER|Difference in ITT clinical success (tedizolid - linezolid)|Difference in clinical success|-7.6|||||TWO_SIDED|95.0|-14.7|-0.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-0.5|-14.7|
74006757|NCT02019420|147563000|OTHER|Difference in CE clinical success (tedizolid - linezolid)|Difference in clinical success|-6.5|||||TWO_SIDED|95.0|-15.1|2.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||2.1|-15.1|
74006758|NCT02019420|147563001|OTHER|Difference in MSSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.5|||||TWO_SIDED|95.0|-12.5|9.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||9.5|-12.5|
74038747|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.73|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-62.82|-52.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.65|-62.82|<0.001
74038748|NCT01763866|147630763|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.04|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|-58.1|-45.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-45.98|-58.10|<0.001
74038749|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|82.4|||<|0.001|TWO_SIDED|95.0|70.2|88.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||88.5|70.2|<0.001
74038750|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.3|||<|0.001|TWO_SIDED|95.0|67.9|86.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||86.8|67.9|<0.001
74038751|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|68.1|||<|0.001|TWO_SIDED|95.0|53.1|78.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||78.1|53.1|<0.001
74038752|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|69.2|||<|0.001|TWO_SIDED|95.0|54.8|78.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||78.5|54.8|<0.001
74038753|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.7|||<|0.001|TWO_SIDED|95.0|67.3|88.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||88.3|67.3|<0.001
74038754|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|83.3|||<|0.001|TWO_SIDED|95.0|70.7|89.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||89.6|70.7|<0.001
74038755|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|43.5|||<|0.001|TWO_SIDED|95.0|29.5|56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||56.7|29.5|<0.001
74038756|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|30.3|||<|0.001|TWO_SIDED|95.0|16.7|44.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||44.2|16.7|<0.001
74038757|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.7|||<|0.001|TWO_SIDED|95.0|69.5|88.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||88.0|69.5|<0.001
74038758|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|84.6|||<|0.001|TWO_SIDED|95.0|73.1|90.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||90.2|73.1|<0.001
74038759|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|54.6|||<|0.001|TWO_SIDED|95.0|39.8|66.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||66.9|39.8|<0.001
74038760|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|65.7|||<|0.001|TWO_SIDED|95.0|51.0|76.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||76.6|51.0|<0.001
74006759|NCT02019420|147563002|OTHER|Difference in MRSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|3.1|||||TWO_SIDED|95.0|-12.8|18.9|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||18.9|-12.8|
74006760|NCT02019420|147563003|OTHER|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||TWO_SIDED|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-4.5|-21.7|
74006761|NCT02019420|147563004|OTHER|Difference in ME-1 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||TWO_SIDED|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-4.5|-21.7|
74038761|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|91.7|||<|0.001|TWO_SIDED|95.0|81.6|95.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||95.3|81.6|<0.001
73878463|NCT01300234|147296495|SUPERIORITY_OR_OTHER||percentage of participants|58.5|||<|0.0001|TWO_SIDED|97.5|45.8|71.3||HBeAg-positive participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach is used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA \<400 copies/mL at Week 48 in the TDF group and the ADV group."|||71.3|45.8|<0.0001
73878464|NCT01300234|147296495|SUPERIORITY_OR_OTHER||percentage of participants|25.6|||<|0.0001|TWO_SIDED|97.5|16.7|34.3||HBeAg-negative participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach was used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA \<400 copies/mL at Week 48 in the TDF group and the ADV group."|||34.3|16.7|<0.0001
74006762|NCT02019420|147563005|OTHER|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-12.5|||||TWO_SIDED|95.0|-21.5|-3.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-3.5|-21.5|
74006763|NCT02019420|147563006|OTHER|Difference in ME-2 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.7|||||TWO_SIDED|95.0|-26.2|-1.2|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-1.2|-26.2|
74006764|NCT02510560|147563009|SUPERIORITY|||||||0.115|||||||Stratified Van Elteren Test|||||||0.115
74006765|NCT02510560|147563009|SUPERIORITY|||||||0.243|||||||Stratified Van Elteren Test|||||||0.243
74006766|NCT02510560|147563010|SUPERIORITY|||||||0.714|||||||Stratified Van Elteren Test|||||||0.714
74006767|NCT02510560|147563010|SUPERIORITY|||||||0.243|||||||Stratified Van Elteren Test|||||||0.243
74006768|NCT04722250|147563025|NON_INFERIORITY|The endpoint is designed to test whether the Medtronic SE TAV is non-inferior to Edwards BE TAV in the composite event rate of all-cause mortality, disabling stroke or heart failure rehospitalization at 12 months post-procedure with an absolute non-inferiority margin of 8.0%.|Risk Difference (RD)|-1.2|||<|0.001|TWO_SIDED|90.0|-4.9|2.5|||z-test on Kaplan-Meier percentages|||||2.5|-4.9|<0.001
74006769|NCT04722250|147563026|SUPERIORITY||Risk Difference (RD)|-32.2|||<|0.001|TWO_SIDED|95.0|-38.7|-25.6|||z-test on Kaplan-Meier percentages|||||-25.6|-38.7|<0.001
74006770|NCT01009554|147563055|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.126|STANDARD_ERROR_OF_MEAN|0.0905||0.168|TWO_SIDED|95.0|-0.054|0.306||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.306|-0.054|0.168
74006771|NCT01009554|147563057|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.006|STANDARD_ERROR_OF_MEAN|0.067||0.928|TWO_SIDED|95.0|-0.127|0.139||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.139|-0.127|0.928
74006772|NCT01009554|147563058|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.235|STANDARD_ERROR_OF_MEAN|0.0718||0.002|TWO_SIDED|95.0|0.092|0.378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.378|0.092|0.002
74006773|NCT01009554|147563059|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.041|STANDARD_ERROR_OF_MEAN|0.1235||0.741|TWO_SIDED|95.0|-0.205|0.286||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.286|-0.205|0.741
74006774|NCT01009554|147563060|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.161|STANDARD_ERROR_OF_MEAN|0.1386||0.249|TWO_SIDED|95.0|-0.437|0.115||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.115|-0.437|0.249
74006775|NCT01009554|147563061|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.201|STANDARD_ERROR_OF_MEAN|0.1398||0.154|TWO_SIDED|95.0|-0.479|0.077||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.077|-0.479|0.154
74006776|NCT01009554|147563062|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.195|STANDARD_ERROR_OF_MEAN|0.0746||0.011|TWO_SIDED|95.0|-0.343|-0.047||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.047|-0.343|0.011
74006777|NCT01009554|147563063|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.334|STANDARD_ERROR_OF_MEAN|0.0703|<|0.001|TWO_SIDED|95.0|-0.474|-0.195||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.195|-0.474|<0.001
74006778|NCT01009554|147563064|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.0939||0.025|TWO_SIDED|95.0|-0.401|-0.027||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.027|-0.401|0.025
74006779|NCT01009554|147563065|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.056|STANDARD_ERROR_OF_MEAN|0.0562||0.319|TWO_SIDED|95.0|-0.055|0.168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.168|-0.055|0.319
74006780|NCT01009554|147563066|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.272|STANDARD_ERROR_OF_MEAN|0.0668|<|0.001|TWO_SIDED|95.0|0.139|0.405||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.405|0.139|<0.001
74006781|NCT01009554|147563067|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.398|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|0.231|0.565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.565|0.231|<0.001
74006782|NCT01009554|147563068|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.0271||0.27|TWO_SIDED|95.0|-0.024|0.084||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.084|-0.024|0.270
74006783|NCT01009554|147563069|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.137|STANDARD_ERROR_OF_MEAN|0.0324|<|0.001|TWO_SIDED|95.0|0.073|0.202||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.202|0.073|<0.001
74006784|NCT01009554|147563070|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.193|STANDARD_ERROR_OF_MEAN|0.0399|<|0.001|TWO_SIDED|95.0|0.114|0.273||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.273|0.114|<0.001
74006785|NCT01009554|147563071|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.0273||0.217|TWO_SIDED|95.0|-0.02|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.088|-0.020|0.217
74006786|NCT01009554|147563072|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.137|STANDARD_ERROR_OF_MEAN|0.032|<|0.001|TWO_SIDED|95.0|0.073|0.2||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.200|0.073|<0.001
74006787|NCT01009554|147563073|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.195|STANDARD_ERROR_OF_MEAN|0.0406|<|0.001|TWO_SIDED|95.0|0.114|0.276||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.276|0.114|<0.001
74006788|NCT01009554|147563074|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.055|STANDARD_ERROR_OF_MEAN|0.0716||0.444|TWO_SIDED|95.0|-0.087|0.197||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.197|-0.087|0.444
74006789|NCT01009554|147563075|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.349|STANDARD_ERROR_OF_MEAN|0.0843|<|0.001|TWO_SIDED|95.0|0.182|0.517||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.517|0.182|<0.001
74006790|NCT01009554|147563076|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.542|STANDARD_ERROR_OF_MEAN|0.1063|<|0.001|TWO_SIDED|95.0|0.331|0.754||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.754|0.331|<0.001
74006791|NCT01009554|147563077|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.032|STANDARD_ERROR_OF_MEAN|0.0344||0.361|TWO_SIDED|95.0|-0.037|0.1||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.100|-0.037|0.361
74006792|NCT01009554|147563078|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.0414|<|0.001|TWO_SIDED|95.0|0.092|0.256||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.256|0.092|<0.001
74006793|NCT01009554|147563079|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.264|STANDARD_ERROR_OF_MEAN|0.0504|<|0.001|TWO_SIDED|95.0|0.164|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.364|0.164|<0.001
74006794|NCT01009554|147563080|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.0345||0.331|TWO_SIDED|95.0|-0.035|0.102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.102|-0.035|0.331
74006795|NCT01009554|147563081|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.177|STANDARD_ERROR_OF_MEAN|0.0414|<|0.001|TWO_SIDED|95.0|0.095|0.259||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.259|0.095|<0.001
74006796|NCT01009554|147563082|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.265|STANDARD_ERROR_OF_MEAN|0.0519|<|0.001|TWO_SIDED|95.0|0.162|0.368||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.368|0.162|<0.001
74006797|NCT01009554|147563083|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.138|STANDARD_ERROR_OF_MEAN|0.0726||0.06|TWO_SIDED|95.0|-0.006|0.282||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.282|-0.006|0.060
74006798|NCT01009554|147563084|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.338|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|0.165|0.51||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.510|0.165|<0.001
74006799|NCT01009554|147563085|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.394|STANDARD_ERROR_OF_MEAN|0.1095|<|0.001|TWO_SIDED|95.0|0.176|0.612||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.612|0.176|<0.001
74006800|NCT01009554|147563086|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.072|STANDARD_ERROR_OF_MEAN|0.0355||0.045|TWO_SIDED|95.0|0.002|0.143||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.143|0.002|0.045
74006801|NCT01009554|147563087|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.178|STANDARD_ERROR_OF_MEAN|0.0415|<|0.001|TWO_SIDED|95.0|0.095|0.26||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.260|0.095|<0.001
74006802|NCT01009554|147563088|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.197|STANDARD_ERROR_OF_MEAN|0.052|<|0.001|TWO_SIDED|95.0|0.094|0.3||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.300|0.094|<0.001
74006803|NCT01009554|147563089|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.077|STANDARD_ERROR_OF_MEAN|0.0355||0.034|TWO_SIDED|95.0|0.006|0.147||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.147|0.006|0.034
74038762|NCT01763866|147630764|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|84.6|||<|0.001|TWO_SIDED|95.0|72.8|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||90.0|72.8|<0.001
74038763|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|83.5|||<|0.001|TWO_SIDED|95.0|71.9|89.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||89.2|71.9|<0.001
74038764|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|78.3|||<|0.001|TWO_SIDED|95.0|65.2|85.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||85.3|65.2|<0.001
74038765|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|63.0|||<|0.001|TWO_SIDED|95.0|47.3|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||73.9|47.3|<0.001
74038766|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.9|||<|0.001|TWO_SIDED|95.0|49.8|75.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||75.2|49.8|<0.001
74038767|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.1|||<|0.001|TWO_SIDED|95.0|65.8|87.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||87.9|65.8|<0.001
74038768|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.2|||<|0.001|TWO_SIDED|95.0|67.9|88.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||88.1|67.9|<0.001
74038769|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|41.1|||<|0.001|TWO_SIDED|95.0|26.4|55.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||55.1|26.4|<0.001
73878465|NCT00550407|147296551|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Log Rank|||||||0.010
74006804|NCT01009554|147563090|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.168|STANDARD_ERROR_OF_MEAN|0.0398|<|0.001|TWO_SIDED|95.0|0.089|0.247||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.247|0.089|<0.001
74091187|NCT01366443|147736138|SUPERIORITY_OR_OTHER||Negative Predictive Value|0.99|||||TWO_SIDED|95.0|0.94|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.||1.00|0.94|
74091188|NCT00321594|147736139|OTHER||Maximum Tolerated Dose|1400.0|||||TWO_SIDED||||||||MTD was not reached and the maximum dose of 1400 mg/m2 is used in Phase II portion|MTD is defined as the dose below which \>=2 of 3 or \>= 2 of 6 patients experience DLT||||
74091189|NCT01673698|147736161|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED||||||t-test, 1 sided|||||||0.0041
74091190|NCT01673698|147736162|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 1 sided|||||||<0.0001
74091191|NCT01673698|147736163|SUPERIORITY_OR_OTHER|||||||0.561|TWO_SIDED||||||Chi-squared|||||||0.5610
74091192|NCT00507546|147736164|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED|95.0|||||Friedman|||||||0.70
74006805|NCT01009554|147563091|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.193|STANDARD_ERROR_OF_MEAN|0.0516|<|0.001|TWO_SIDED|95.0|0.091|0.296||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.296|0.091|<0.001
74038770|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|35.2|||<|0.001|TWO_SIDED|95.0|20.7|49.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||49.3|20.7|<0.001
74038771|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|77.3|||<|0.001|TWO_SIDED|95.0|63.9|84.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||84.7|63.9|<0.001
74038772|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.1|||<|0.001|TWO_SIDED|95.0|68.8|87.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||87.5|68.8|<0.001
74038773|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|52.7|||<|0.001|TWO_SIDED|95.0|37.6|65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||65.3|37.6|<0.001
74038774|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.3|||<|0.001|TWO_SIDED|95.0|49.1|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||75.5|49.1|<0.001
74038775|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|92.5|||<|0.001|TWO_SIDED|95.0|82.3|95.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||95.9|82.3|<0.001
74038776|NCT01763866|147630765|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|78.4|||<|0.001|TWO_SIDED|95.0|64.9|85.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||85.4|64.9|<0.001
74038777|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.08|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-39.06|-25.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.11|-39.06|<0.001
74091193|NCT00507546|147736165|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Friedman|||||||0.35
74091194|NCT00375492|147736205|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Model Repeated Measures|||||||0.0030
74091195|NCT00375492|147736206|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures|||||||<0.0001
74091196|NCT00375492|147736208|SUPERIORITY_OR_OTHER|||||||0.1985||95.0|||||Mixed Model Repeated Measures|||||||0.1985
73878466|NCT05051579|147296569|SUPERIORITY||LS Mean difference (Final Values)|-6.5|||<|0.001|TWO_SIDED|95.0|-8.9|-4.2|||Mixed Models Analysis|||||-4.2|-8.9|<0.001
74091197|NCT00375492|147736209|SUPERIORITY_OR_OTHER|||||||0.1827||95.0|||||ANCOVA|||||||0.1827
74091198|NCT00375492|147736210|SUPERIORITY_OR_OTHER|||||||0.1584||95.0|||||ANCOVA|||||||0.1584
74091199|NCT00375492|147736211|SUPERIORITY_OR_OTHER|||||||0.8279||95.0|||||ANCOVA|||||||0.8279
74091200|NCT00375492|147736212|SUPERIORITY_OR_OTHER|||||||0.8334||95.0|||||ANCOVA|||||||0.8334
74091201|NCT00375492|147736213|SUPERIORITY_OR_OTHER|||||||0.2881||95.0|||||ANCOVA|||||||0.2881
74091202|NCT00375492|147736214|SUPERIORITY_OR_OTHER|||||||0.0654||95.0|||||ANCOVA|||||||0.0654
74091203|NCT00375492|147736215|SUPERIORITY_OR_OTHER|||||||0.728||95.0|||||Cochran-Mantel-Haenszel|||||||0.728
74091204|NCT00375492|147736216|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||ANOVA|||||||0.127
74091205|NCT01663727|147736218|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0007|TWO_SIDED|99.0|0.51|0.91|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||0.91|0.51|0.0007
74006806|NCT01009554|147563092|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.031||0.524|TWO_SIDED|95.0|-0.082|0.042||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.042|-0.082|0.524
74038778|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.86|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-29.7|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.03|-29.70|<0.001
74038779|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.45|STANDARD_ERROR_OF_MEAN|3.59|<|0.001|TWO_SIDED|95.0|-34.53|-20.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-20.38|-34.53|<0.001
74038780|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.49|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-37.36|-21.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.62|-37.36|<0.001
74038781|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.52|STANDARD_ERROR_OF_MEAN|3.65|<|0.001|TWO_SIDED|95.0|-27.71|-13.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.33|-27.71|<0.001
74038782|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.96|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-37.01|-20.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-20.92|-37.01|<0.001
74038783|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.02|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-39.11|-24.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.93|-39.11|<0.001
74038784|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.42|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-45.61|-29.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.23|-45.61|<0.001
74038785|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.66|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-42.94|-28.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.38|-42.94|<0.001
74038786|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.81|STANDARD_ERROR_OF_MEAN|4.33|<|0.001|TWO_SIDED|95.0|-35.36|-18.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-18.27|-35.36|<0.001
74038787|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.56|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-40.74|-26.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.37|-40.74|<0.001
74038788|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.19|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-40.8|-23.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.58|-40.80|<0.001
74038789|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.07|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-34.91|-21.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.23|-34.91|<0.001
74038790|NCT01763866|147630766|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.16|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-34.59|-19.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-19.73|-34.59|<0.001
74038791|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.2|STANDARD_ERROR_OF_MEAN|3.86|<|0.001|TWO_SIDED|95.0|-40.81|-25.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.60|-40.81|<0.001
74038792|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.82|STANDARD_ERROR_OF_MEAN|4.11|<|0.001|TWO_SIDED|95.0|-27.92|-11.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.72|-27.92|<0.001
73878467|NCT05051579|147296569|SUPERIORITY||LS Mean difference (Final Values)|-9.2|||<|0.001|TWO_SIDED|95.0|-11.5|-6.9|||Mixed Models Analysis|||||-6.9|-11.5|<0.001
74006807|NCT01009554|147563093|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.055|STANDARD_ERROR_OF_MEAN|0.0395||0.172|TWO_SIDED|95.0|-0.024|0.133||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.133|-0.024|0.172
74006808|NCT01009554|147563094|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.116|STANDARD_ERROR_OF_MEAN|0.0439||0.01|TWO_SIDED|95.0|0.028|0.203||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.203|0.028|0.010
74006809|NCT01009554|147563095|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.014|STANDARD_ERROR_OF_MEAN|0.0145||0.348|TWO_SIDED|95.0|-0.043|0.015||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.015|-0.043|0.348
74006810|NCT01009554|147563096|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.025|STANDARD_ERROR_OF_MEAN|0.0186||0.185|TWO_SIDED|95.0|-0.012|0.062||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.062|-0.012|0.185
74006811|NCT01009554|147563097|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.049|STANDARD_ERROR_OF_MEAN|0.0196||0.014|TWO_SIDED|95.0|0.01|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.088|0.010|0.014
74006812|NCT01009554|147563098|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.016||0.623|TWO_SIDED|95.0|-0.04|0.024||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.024|-0.040|0.623
74006813|NCT01009554|147563099|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0186||0.192|TWO_SIDED|95.0|-0.013|0.061||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.061|-0.013|0.192
74006814|NCT01009554|147563100|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.057|STANDARD_ERROR_OF_MEAN|0.0213||0.009|TWO_SIDED|95.0|0.014|0.099||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.099|0.014|0.009
74006815|NCT01009554|147563101|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.0384||0.893|TWO_SIDED|95.0|-0.081|0.071||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.071|-0.081|0.893
74006816|NCT01009554|147563102|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.021|STANDARD_ERROR_OF_MEAN|0.0476||0.655|TWO_SIDED|95.0|-0.073|0.116||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.116|-0.073|0.655
74006817|NCT01009554|147563103|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.222|STANDARD_ERROR_OF_MEAN|0.0693||0.002|TWO_SIDED|95.0|0.084|0.359||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.359|0.084|0.002
74006818|NCT01009554|147563104|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.002|STANDARD_ERROR_OF_MEAN|0.0187||0.914|TWO_SIDED|95.0|-0.039|0.035||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.035|-0.039|0.914
74091206|NCT01663727|147736218|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0046|TWO_SIDED|99.0|0.55|0.97|||Log Rank|||Unstratified Analysis.||0.97|0.55|0.0046
73878468|NCT05051579|147296569|SUPERIORITY||LS Mean difference (Final Values)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.4|-8.0|||Mixed Models Analysis|||||-8.0|-12.4|<0.001
73878469|NCT05051579|147296569|SUPERIORITY||LS Mean difference (Final Values)|-10.6|||<|0.001|TWO_SIDED|95.0|-12.7|-8.4|||Mixed Models Analysis|||||-8.4|-12.7|<0.001
73878470|NCT05051579|147296570|OTHER||LS Mean difference (Final Values)|-7.1|||<|0.001|TWO_SIDED|95.0|-9.9|-4.2|||Mixed Models Analysis|||||-4.2|-9.9|<0.001
73878471|NCT05051579|147296570|OTHER||LS Mean difference (Final Values)|-10.1|||<|0.001|TWO_SIDED|95.0|-12.9|-7.3|||Mixed Models Analysis|||||-7.3|-12.9|<0.001
73878472|NCT05051579|147296570|OTHER||LS Mean difference (Final Values)|-11.1|||<|0.001|TWO_SIDED|95.0|-13.8|-8.4|||Mixed Models Analysis|||||-8.4|-13.8|<0.001
74006819|NCT01009554|147563105|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0229||0.646|TWO_SIDED|95.0|-0.035|0.056||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.056|-0.035|0.646
74038793|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.16|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-36.87|-21.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.44|-36.87|<0.001
74038794|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.44|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-35.56|-19.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-19.32|-35.56|<0.001
74038795|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.38|STANDARD_ERROR_OF_MEAN|4.07|<|0.001|TWO_SIDED|95.0|-30.39|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.36|-30.39|<0.001
74038796|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.1|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-36.62|-19.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-19.58|-36.62|<0.001
74038797|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.62|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-40.46|-24.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.78|-40.46|<0.001
74038798|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.88|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-43.52|-26.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.25|-43.52|<0.001
74038799|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.5|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-44.69|-28.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.30|-44.69|<0.001
74038800|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.34|STANDARD_ERROR_OF_MEAN|4.48|<|0.001|TWO_SIDED|95.0|-34.19|-16.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-16.49|-34.19|<0.001
74038801|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.48|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-43.95|-29.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.02|-43.95|<0.001
74038802|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.17|STANDARD_ERROR_OF_MEAN|5.28|<|0.001|TWO_SIDED|95.0|-42.61|-21.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.74|-42.61|<0.001
74038803|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.25|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-38.4|-24.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.10|-38.40|<0.001
74038804|NCT01763866|147630767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.17|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-36.79|-19.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-19.55|-36.79|<0.001
73957348|NCT03670602|147450837|SUPERIORITY|A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||||0.345||||||This is for the treatment group x time effect, or if treatment group influenced change in percent of time engaged in moderate-to-vigorous physical activity (MVPA) across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||||||0.345
74038805|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-12.1|STANDARD_ERROR_OF_MEAN|4.83||0.2|TWO_SIDED|95.0|-21.63|-2.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-2.58|-21.63|0.20
74038806|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.55|STANDARD_ERROR_OF_MEAN|5.36||0.003|TWO_SIDED|95.0|-33.13|-11.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.97|-33.13|0.003
74038807|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.45|STANDARD_ERROR_OF_MEAN|4.89||1|TWO_SIDED|95.0|-12.09|7.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.19|-12.09|1.00
73957349|NCT03670602|147450837|SUPERIORITY|||||||0.0003||||||This is for the time effect, or if percent of time engaged in moderate-to-vigorous physical activity (MVPA) changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.0003
73957350|NCT03670602|147450838|SUPERIORITY|||||||0.007||||||This is for the treatment group x time effect, or if treatment differentially influenced changes in calorie intake across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.007
73957351|NCT03670602|147450838|SUPERIORITY||||||<|0.0001||||||This is for the time effect, or if time influenced changes in calorie intake, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.0001
73957352|NCT03670602|147450839|SUPERIORITY|||||||0.774||||||This is for the treatment group x time effect, or if treatment differentially influenced changes in working memory across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.774
73957353|NCT03670602|147450839|SUPERIORITY|||||||0.019||||||This is for the time effect, or if time influenced changes in working memory, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.019
73957354|NCT03670602|147450840|SUPERIORITY|||||||0.65||||||This is for the treatment group x time effect, or if treatment differentially influenced relative reinforcing efficacy of unhealthy food across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.650
73957355|NCT03670602|147450840|SUPERIORITY||||||<|0.0001||||||This is for the time effect, or if time influenced changes in relative reinforcing efficacy of unhealthy food, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.0001
73957356|NCT00543725|147450841|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.7|||<|0.0001||95.0|-1.6|9.0||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||9.0|-1.6|<0.0001
73957357|NCT00543725|147450842|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.9|||<|0.0001||95.0|-1.9|9.6|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||9.6|-1.9|<0.0001
74091207|NCT01663727|147736218|SUPERIORITY_OR_OTHER|||||||0.4619|TWO_SIDED||||||Wald Test|||A stratified multivariate Cox regression model, including treatment, VEGF-A level, and interaction between treatment and VEGF-A level (low, high) as factors was used to estimate the interaction p-value of the treatment with VEGF-A level for PFS. Analysis for the interaction of treatment effect with the plasma VEGF-A levels was a secondary objective.||||0.4619
74006820|NCT01009554|147563106|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.102|STANDARD_ERROR_OF_MEAN|0.0309||0.001|TWO_SIDED|95.0|0.04|0.163||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.163|0.040|0.001
74006821|NCT01009554|147563107|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.0179||0.93|TWO_SIDED|95.0|-0.034|0.037||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.037|-0.034|0.930
74038808|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.95|STANDARD_ERROR_OF_MEAN|5.33||0.053|TWO_SIDED|95.0|-25.46|-4.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.44|-25.46|0.053
74038809|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.43|STANDARD_ERROR_OF_MEAN|4.89||0.073|TWO_SIDED|95.0|-25.06|-5.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.79|-25.06|0.073
74038810|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.41|STANDARD_ERROR_OF_MEAN|5.32||0.027|TWO_SIDED|95.0|-24.9|-3.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-3.92|-24.90|0.027
74038811|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.17|STANDARD_ERROR_OF_MEAN|4.8||1|TWO_SIDED|95.0|-10.63|8.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.30|-10.63|1.00
74038812|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.51|STANDARD_ERROR_OF_MEAN|5.38||0.63|TWO_SIDED|95.0|-12.12|9.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.11|-12.12|0.63
74038813|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.72|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|95.0|-32.9|-12.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-12.54|-32.90|<0.001
74038814|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.52|STANDARD_ERROR_OF_MEAN|5.69||0.007|TWO_SIDED|95.0|-30.76|-8.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.28|-30.76|0.007
74038815|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-17.59|STANDARD_ERROR_OF_MEAN|4.62||0.002|TWO_SIDED|95.0|-26.71|-8.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.46|-26.71|0.002
74038816|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.18|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-35.76|-16.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-16.59|-35.76|<0.001
74038817|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.97|STANDARD_ERROR_OF_MEAN|5.78|<|0.001|TWO_SIDED|95.0|-32.38|-9.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.55|-32.38|<0.001
74038818|NCT01763866|147630768|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.71|STANDARD_ERROR_OF_MEAN|5.64|<|0.001|TWO_SIDED|95.0|-40.84|-18.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-18.57|-40.84|<0.001
74038819|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-12.06|STANDARD_ERROR_OF_MEAN|6.41||0.2|TWO_SIDED|95.0|-24.69|0.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||0.57|-24.69|0.20
74091208|NCT01663727|147736220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5877|TWO_SIDED|95.0|0.75|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.18|0.75|0.5877
74091209|NCT01663727|147736220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8004|TWO_SIDED|95.0|0.78|1.21|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.21|0.78|0.8004
73878473|NCT05051579|147296570|OTHER||LS Mean difference (Final Values)|-12.3|||<|0.001|TWO_SIDED|95.0|-15.0|-9.6|||Mixed Models Analysis|||||-9.6|-15.0|<0.001
73878474|NCT05051579|147296571|OTHER||LS Mean difference (Final Values)|-6.9|||<|0.001|TWO_SIDED|95.0|-9.3|-4.4|||Mixed Models Analysis|||||-4.4|-9.3|<0.001
73957358|NCT00543725|147450843|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|2.4|||<|0.0001||95.0|-3.6|8.4||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||8.4|-3.6|<0.0001
74038820|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.6|STANDARD_ERROR_OF_MEAN|7.23||0.003|TWO_SIDED|95.0|-41.86|-13.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.35|-41.86|0.003
74038821|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-3.37|STANDARD_ERROR_OF_MEAN|6.49||1|TWO_SIDED|95.0|-16.16|9.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.43|-16.16|1.00
74038822|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.13|STANDARD_ERROR_OF_MEAN|7.18||0.053|TWO_SIDED|95.0|-32.28|-3.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-3.99|-32.28|0.053
74038823|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.72|STANDARD_ERROR_OF_MEAN|5.39||0.073|TWO_SIDED|95.0|-27.34|-6.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-6.10|-27.34|0.073
74038824|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-9.31|STANDARD_ERROR_OF_MEAN|6.39||0.027|TWO_SIDED|95.0|-21.92|3.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||3.29|-21.92|0.027
74038825|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.67|STANDARD_ERROR_OF_MEAN|5.27||1|TWO_SIDED|95.0|-13.05|7.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.72|-13.05|1.00
74038826|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|2.02|STANDARD_ERROR_OF_MEAN|6.43||0.63|TWO_SIDED|95.0|-10.66|14.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||14.69|-10.66|0.63
74038827|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.03|STANDARD_ERROR_OF_MEAN|7.08|<|0.001|TWO_SIDED|95.0|-32.03|-4.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.04|-32.03|<0.001
74038828|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.83|STANDARD_ERROR_OF_MEAN|6.52||0.007|TWO_SIDED|95.0|-32.71|-6.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-6.96|-32.71|0.007
73878475|NCT05051579|147296571|OTHER||LS Mean difference (Final Values)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.5|-7.8|||Mixed Models Analysis|||||-7.8|-12.5|<0.001
73878476|NCT05051579|147296571|OTHER||LS Mean difference (Final Values)|-10.8|||<|0.001|TWO_SIDED|95.0|-13.1|-8.5|||Mixed Models Analysis|||||-8.5|-13.1|<0.001
73878477|NCT05051579|147296571|OTHER||LS Mean difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.5|-8.9|||Mixed Models Analysis|||||-8.9|-13.5|<0.001
73878478|NCT05051579|147296572|OTHER||LS Mean difference (Final Values)|-7.4|||<|0.001|TWO_SIDED|95.0|-10.4|-4.3|||Mixed Models Analysis|||||-4.3|-10.4|<0.001
73878479|NCT05051579|147296572|OTHER||LS Mean difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-14.2|-8.3|||Mixed Models Analysis|||||-8.3|-14.2|<0.001
73878480|NCT05051579|147296572|OTHER||LS Mean difference (Final Values)|-11.8|||<|0.001|TWO_SIDED|95.0|-14.7|-9.0|||Mixed Models Analysis|||||-9.0|-14.7|<0.001
73878481|NCT05051579|147296572|OTHER||LS Mean difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.8|-10.2|||Mixed Models Analysis|||||-10.2|-15.8|<0.001
73878482|NCT05051579|147296573|OTHER||LS Mean difference (Final Values)|-4.4||||0.002|TWO_SIDED|95.0|-7.2|-1.6|||Mixed Models Analysis|||||-1.6|-7.2|0.002
73878483|NCT05051579|147296573|OTHER||LS Mean difference (Final Values)|-5.2|||<|0.001|TWO_SIDED|95.0|-8.0|-2.4|||Mixed Models Analysis|||||-2.4|-8.0|<0.001
73878484|NCT05051579|147296573|OTHER||LS Mean difference (Final Values)|-6.5|||<|0.001|TWO_SIDED|95.0|-9.2|-3.8|||Mixed Models Analysis|||||-3.8|-9.2|<0.001
74006822|NCT01009554|147563108|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.0224||0.486|TWO_SIDED|95.0|-0.029|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.060|-0.029|0.486
74006823|NCT01009554|147563109|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.112|STANDARD_ERROR_OF_MEAN|0.0338||0.001|TWO_SIDED|95.0|0.045|0.18||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.180|0.045|0.001
74006824|NCT01009554|147563110|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.1006||0.237|TWO_SIDED|95.0|-0.08|0.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.320|-0.080|0.237
74006825|NCT01009554|147563111|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.521|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|0.298|0.743||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.743|0.298|<0.001
74006826|NCT01009554|147563112|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.567|STANDARD_ERROR_OF_MEAN|0.1367|<|0.001|TWO_SIDED|95.0|0.295|0.839||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.839|0.295|<0.001
74006827|NCT01009554|147563113|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.062|STANDARD_ERROR_OF_MEAN|0.0491||0.21|TWO_SIDED|95.0|-0.036|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.160|-0.036|0.210
74006828|NCT01009554|147563114|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.262|STANDARD_ERROR_OF_MEAN|0.055|<|0.001|TWO_SIDED|95.0|0.153|0.372||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.372|0.153|<0.001
74006829|NCT01009554|147563115|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.281|STANDARD_ERROR_OF_MEAN|0.0654|<|0.001|TWO_SIDED|95.0|0.151|0.411||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.411|0.151|<0.001
74006830|NCT01009554|147563116|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.066|STANDARD_ERROR_OF_MEAN|0.0496||0.187|TWO_SIDED|95.0|-0.033|0.165||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.165|-0.033|0.187
74006831|NCT01009554|147563117|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.256|STANDARD_ERROR_OF_MEAN|0.0544|<|0.001|TWO_SIDED|95.0|0.148|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.364|0.148|<0.001
74006832|NCT01009554|147563118|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.273|STANDARD_ERROR_OF_MEAN|0.0669|<|0.001|TWO_SIDED|95.0|0.14|0.406||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.406|0.140|<0.001
74006833|NCT01405937|147563124|SUPERIORITY_OR_OTHER||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.||||<0.001
74091210|NCT01663727|147736222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2745|TWO_SIDED|95.0|0.63|1.14|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.14|0.63|0.2745
73878485|NCT05051579|147296573|OTHER||LS Mean difference (Final Values)|-8.7|||<|0.001|TWO_SIDED|95.0|-11.3|-6.0|||Mixed Models Analysis|||||-6.0|-11.3|<0.001
73878486|NCT05051579|147296574|OTHER||LS Mean difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-8.8|-2.4|||Mixed Models Analysis|||||-2.4|-8.8|<0.001
73878487|NCT05051579|147296574|OTHER||LS Mean difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.3|-4.0|||Mixed Models Analysis|||||-4.0|-10.3|<0.001
73878488|NCT05051579|147296574|OTHER||LS Mean difference (Final Values)|-6.6|||<|0.001|TWO_SIDED|95.0|-9.7|-3.6|||Mixed Models Analysis|||||-3.6|-9.7|<0.001
73878489|NCT05051579|147296574|OTHER||LS Mean difference (Final Values)|-9.6|||<|0.001|TWO_SIDED|95.0|-12.7|-6.6|||Mixed Models Analysis|||||-6.6|-12.7|<0.001
73957359|NCT00543725|147450844|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.7|||<|0.0001||95.0|-5.6|7.0|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||7.0|-5.6|<0.0001
74006834|NCT01405937|147563124|SUPERIORITY_OR_OTHER||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.||||<0.001
74006835|NCT02554903|147563132|SUPERIORITY||Geometric Mean Ratio|0.7393||||0.0158|TWO_SIDED|95.0|0.5798|0.9426|||ANCOVA|||||0.9426|0.5798|0.0158
74006836|NCT03951220|147563159|SUPERIORITY|||||||0.7343|||||||ANOVA|||||||0.7343
74006837|NCT03951220|147563160|OTHER|Correlation|Spearman (r)|0.39||||0.0445|TWO_SIDED|95.0|0.0|0.68|||Spearman's rank correlation coeffcieitn|||||0.68|0.00|0.0445
74006838|NCT03951220|147563161|SUPERIORITY|||||||0.0079||||||Dunn's multiple comparisons test|Kruskal-Wallis|||For baseline P1NP||||0.0079
74006839|NCT03951220|147563161|SUPERIORITY|||||||0.0482||||||Dunn's multiple comparison test|ANOVA|||For baseline sclerostin||||0.0482
74006840|NCT03951220|147563172|OTHER|||||||0.015|||||||Fisher-Freeman-Halton exact test|||||||0.015
74006841|NCT03951220|147563175|OTHER|||||||0.007|||||||Mann-Whitney test|||||||0.007
74006842|NCT02564926|147563228|OTHER||LS mean difference (kg)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.346|-1.819|||ANCOVA|||||-1.819|-3.346|<0.001
74006843|NCT02564926|147563229|OTHER||LS mean difference (%)|-0.46||||0.014|TWO_SIDED|95.0|-0.821|-0.094|||Mixed Models Analysis|||||-0.094|-0.821|0.014
74006844|NCT02564926|147563230|OTHER||Odds Ratio (OR)|1.45||||0.343|TWO_SIDED|95.0|0.673|3.113|||Regression, Logistic|||||3.113|0.673|0.343
74006845|NCT02564926|147563231|OTHER||LS mean difference (mg/dL)|-18.25||||0.006|TWO_SIDED|95.0|-31.14|-5.351|||Mixed Models Analysis|||||-5.351|-31.140|0.006
74006846|NCT02564926|147563232|OTHER||LS mean difference (kg)|-3.7|||<|0.001|TWO_SIDED|95.0|-4.667|-2.631|||Mixed Models Analysis|||||-2.631|-4.667|<0.001
74006847|NCT02564926|147563233|OTHER||LS mean difference (cm)|-2.21||||0.006|TWO_SIDED|95.0|-3.785|-0.635|||Mixed Models Analysis|||||-0.635|-3.785|0.006
74006848|NCT02564926|147563234|OTHER||LS mean difference (kg/m2)|-1.37|||<|0.001|TWO_SIDED|95.0|-1.742|-0.99|||Mixed Models Analysis|||||-0.990|-1.742|<0.001
74006849|NCT02564926|147563235|OTHER||LS mean difference (mmHg)|-6.81||||0.002|TWO_SIDED|95.0|-10.969|-2.641|||Mixed Models Analysis|||||-2.641|-10.969|0.002
74006850|NCT02564926|147563236|OTHER||LS mean difference (mmHg)|-2.61||||0.11|TWO_SIDED|95.0|-5.829|0.6|||Mixed Models Analysis|||||0.600|-5.829|0.110
74006851|NCT02564926|147563237|OTHER||LS mean difference (cm2)|-17.55||||0.002|TWO_SIDED|95.0|-28.603|-6.489|||ANCOVA|||||-6.489|-28.603|0.002
74006852|NCT02564926|147563238|OTHER||LS mean difference (cm2)|-18.39|||<|0.001|TWO_SIDED|95.0|-27.561|-9.218|||ANCOVA|||||-9.218|-27.561|<0.001
73957360|NCT00906698|147450859|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|126.2|||||TWO_SIDED|90.0|69.549|229.012|||ANOVA|||||229.012|69.549|
74006853|NCT02564926|147563239|OTHER||LS mean difference|-0.03||||0.503|TWO_SIDED|95.0|-0.127|0.063|||ANCOVA|||||0.063|-0.127|0.503
74006854|NCT02564926|147563240|OTHER||LS mean difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.992|-0.54|||ANCOVA|||||-0.540|-1.992|<0.001
74006855|NCT02564926|147563241|OTHER||LS mean difference (ng/mL)|657.71||||0.044|TWO_SIDED|95.0|18.325|1297.101|||ANCOVA|||||1297.101|18.325|0.044
74006856|NCT02564926|147563242|OTHER||LS mean difference (mg/L)|-0.12||||0.756|TWO_SIDED|95.0|-0.858|0.625|||ANCOVA|||||0.625|-0.858|0.756
74006857|NCT02564926|147563243|OTHER||LS mean difference (%)|-1.94|||<|0.001|TWO_SIDED|95.0|-2.807|-1.082|||ANCOVA|||||-1.082|-2.807|<0.001
74006858|NCT02038920|147563248|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1448|TWO_SIDED|95.0|0.816|3.958|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||3.958|0.816|0.1448
74006859|NCT02038920|147563249|SUPERIORITY||Odds Ratio (OR)|3.57||||0.1779|TWO_SIDED|95.0|0.532|23.953|||Pearson's Chi-square Test||MLN0002 group/placebo group|||23.953|0.532|0.1779
74006860|NCT02038920|147563255|SUPERIORITY||Odds Ratio (OR)|1.83||||0.1963|TWO_SIDED|95.0|0.72|4.673|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||4.673|0.720|0.1963
74006861|NCT02038920|147563257|SUPERIORITY||Odds Ratio (OR)|15.4||||0.0094|TWO_SIDED|95.0|1.473|160.972|||Pearson's Chi-square Test|||||160.972|1.473|0.0094
74006862|NCT02038920|147563258|SUPERIORITY||Odds Ratio (OR)|1.5||||0.6534|TWO_SIDED|95.0|0.254|8.844|||Pearson's Chi-square Test||MLN0002 group/placebo group.|||8.844|0.254|0.6534
74006863|NCT02038920|147563259|SUPERIORITY|||||||0.2059|||||||Pearson's Chi-square Test|||||||0.2059
74006864|NCT00866697|147563268|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.766||||0.0021|TWO_SIDED|95.0|0.643|0.911||The P-value from the stratified log-rank test was adjusted for the two stratification factors.|Log Rank||The Hazard Ratio was estimated using a Pike estimator.|||0.911|0.643|0.0021
74006865|NCT00866697|147563269|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.6431|TWO_SIDED|95.0|0.805|1.145|||Log Rank|Stratified Log-Rank P-Value.|"The HR was estimated using a Pike estimator.~CIs were estimated using the Brookmeyer-Crowley method."|||1.145|0.805|0.6431
74006866|NCT01423812|147563312|OTHER||||||<|0.05|||||||t-test, 2 sided|||p value||||<0.05
74006867|NCT01423812|147563313|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74006868|NCT02748018|147563317|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.8|||||ONE_SIDED|97.5||-0.4||||||||-0.4||
74006869|NCT02748018|147563318|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.9|||||ONE_SIDED|97.5||-3.6||||||||-3.6||
74006870|NCT02748018|147563319|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.7|||||ONE_SIDED|97.5||-0.3||||||||-0.3||
74006871|NCT02748018|147563320|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.8|||||ONE_SIDED|97.5||-3.1||||||||-3.1||
73957361|NCT00906698|147450860|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|75.58|||||TWO_SIDED|90.0|65.037|87.837|||ANOVA|||||87.837|65.037|
73878490|NCT05051579|147296575|OTHER||LS Mean difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.2|-1.6|||Mixed Models Analysis|||||-1.6|-3.2|<0.001
73957362|NCT00906698|147450861|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|132.8|||||TWO_SIDED|90.0|72.305|243.917|||ANOVA|||||243.917|72.305|
73957363|NCT00906698|147450862|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|83.8|||||TWO_SIDED|90.0|61.156|114.823|||ANOVA|||||114.823|61.156|
73957364|NCT00906698|147450865|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|90.21|||||TWO_SIDED|90.0|76.071|106.978|||ANOVA|||||106.978|76.071|
73957365|NCT00906698|147450866|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|76.75|||||TWO_SIDED|90.0|56.71|103.871|||ANOVA|||||103.871|56.710|
73957366|NCT00906698|147450867|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|83.86|||||TWO_SIDED|95.0|66.369|105.966|||ANOVA|||||105.966|66.369|
73957367|NCT00906698|147450868|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|81.7|||||TWO_SIDED|90.0|60.47|110.369|||ANOVA|||||110.369|60.470|
73957368|NCT03095508|147450871|SUPERIORITY|||||||0.446|||||||Fisher Exact|||||||0.446
73957369|NCT03095508|147450873|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73957370|NCT03095508|147450874|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||||||0.145
73957371|NCT03095508|147450875|SUPERIORITY|||||||0.188|||||||Wilcoxon (Mann-Whitney)|||||||0.188
73957372|NCT03095508|147450876|NON_INFERIORITY|non-inferiority margin 14.5% absolute difference between percentages in group A and B|Risk Difference (RD)|0.14||||1e-05|TWO_SIDED|95.0|0.03|0.24||p- value for superiority: 0.021|Fisher Exact|||p1=proportion of patients without sore throat at Day 4 in Arm A p2=proportion of patients without sore throat at Day 4 in Arm B Н0: p1 - p2 ≤ -0.145||0.24|0.03|0.00001
73957373|NCT03383887|147450882|SUPERIORITY||Median Difference (Final Values)|2.7||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.56
73957374|NCT03383887|147450883|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
73957375|NCT01651949|147450894|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.11|||<|0.001|TWO_SIDED|95.0|1.02|1.21|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used.||Anti-HPV Type 6||1.21|1.02|<0.001
73957376|NCT01651949|147450894|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|1.0|1.19|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 11||1.19|1.00|<0.001
73957377|NCT01651949|147450894|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 16||1.30|1.10|<0.001
73957378|NCT01651949|147450894|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.08|1.31|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 18||1.31|1.08|<0.001
73957379|NCT01651949|147450894|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.24|||<|0.001|TWO_SIDED|95.0|1.13|1.37|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 31||1.37|1.13|<0.001
73957380|NCT01651949|147450894|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 33||1.30|1.10|<0.001
73957381|NCT01651949|147450894|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.27|||<|0.001|TWO_SIDED|95.0|1.14|1.41|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 45||1.41|1.14|<0.001
73957382|NCT01651949|147450894|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.05|1.26|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 52||1.26|1.05|<0.001
73957383|NCT01651949|147450894|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.14|1.36|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 58||1.36|1.14|<0.001
73957384|NCT01651949|147450895|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-11.5|||<|0.001|TWO_SIDED|95.0|-15.0|-8.0|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Erythema||-8.0|-15.0|<0.001
74038829|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.55|STANDARD_ERROR_OF_MEAN|5.71||0.002|TWO_SIDED|95.0|-27.84|-5.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.26|-27.84|0.002
74038830|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.51|STANDARD_ERROR_OF_MEAN|5.33|<|0.001|TWO_SIDED|95.0|-31.04|-9.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.98|-31.04|<0.001
74038831|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.78|STANDARD_ERROR_OF_MEAN|5.62|<|0.001|TWO_SIDED|95.0|-32.88|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-10.68|-32.88|<0.001
74038832|NCT01763866|147630769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.36|STANDARD_ERROR_OF_MEAN|6.45|<|0.001|TWO_SIDED|95.0|-44.1|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-18.62|-44.10|<0.001
74038833|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-13.36|STANDARD_ERROR_OF_MEAN|4.38||0.088|TWO_SIDED|95.0|-21.99|-4.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.74|-21.99|0.088
74038834|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.31|STANDARD_ERROR_OF_MEAN|5.41||0.005|TWO_SIDED|95.0|-31.98|-10.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-10.64|-31.98|0.005
74038835|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.5|STANDARD_ERROR_OF_MEAN|4.45||1|TWO_SIDED|95.0|-10.27|7.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.27|-10.27|1.00
74006872|NCT02748018|147563321|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.3||||||||0.3||
74006873|NCT02748018|147563322|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-1.0|||||ONE_SIDED|97.5||-0.2||||||||-0.2||
74006874|NCT02748018|147563323|NON_INFERIORITY|Non-inferiority margin: 2%. Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-2.2|||||ONE_SIDED|97.5||-0.9||||||||-0.9||
74006875|NCT02748018|147563324|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.3|||||ONE_SIDED|97.5||-0.1||||||||-0.1||
74006876|NCT02748018|147563325|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) During Night|Mean Difference (Final Values)|-5.4|||||ONE_SIDED|97.5||-3.7||||||||-3.7||
74006877|NCT02748018|147563326|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) During Night|Mean Difference (Final Values)|18.8|||||ONE_SIDED|97.5|14.5||||||||||14.5|
74006878|NCT02748018|147563327|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|12.0|||||ONE_SIDED|97.5|8.8||||||||||8.8|
74006879|NCT02748018|147563328|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-3.6|||||ONE_SIDED|97.5||-2.6||||||||-2.6||
74006880|NCT02748018|147563329|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.6|||||ONE_SIDED|97.5||-0.3||||||||-0.3||
74038836|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-13.54|STANDARD_ERROR_OF_MEAN|5.39||0.056|TWO_SIDED|95.0|-24.17|-2.91||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-2.91|-24.17|0.056
74091211|NCT01663727|147736222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.3616|TWO_SIDED|95.0|0.65|1.17|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.17|0.65|0.3616
74091212|NCT01663727|147736223|SUPERIORITY_OR_OTHER||Difference in Response Rates|20.78|||<|0.0001|TWO_SIDED|95.0|11.45|30.11|||Fisher|||||30.11|11.45|<0.0001
74006881|NCT02748018|147563330|NON_INFERIORITY|Non-inferiority margin: 2%. Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-3.6|||||ONE_SIDED|97.5||-1.9||||||||-1.9||
74006882|NCT02748018|147563331|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.1|||||ONE_SIDED|97.5||0.3||||||||0.3||
74006883|NCT02748018|147563332|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) during Night|Mean Difference (Final Values)|-7.3|||||ONE_SIDED|97.5||-4.7||||||||-4.7||
74006884|NCT02748018|147563333|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) during Night|Mean Difference (Final Values)|15.9|||||ONE_SIDED|97.5|11.1||||||||||11.1|
74006885|NCT02748018|147563334|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|13.6|||||ONE_SIDED|97.5|9.9||||||||||9.9|
74006886|NCT02748018|147563335|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.3|||||ONE_SIDED|97.5||-3.1||||||||-3.1||
74006887|NCT02748018|147563336|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.2|||||ONE_SIDED|97.5||0.0||||||||0.0||
74091213|NCT01663727|147736225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0038|TWO_SIDED|96.0|0.47|0.88|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||0.88|0.47|0.0038
74006888|NCT02748018|147563337|NON_INFERIORITY|Non-inferiority margin: 2%. Treatment Effect on Time in Hypoglycemic Range (%) with Multiple Imputation|Mean Difference (Final Values)|-0.3|||||ONE_SIDED|97.5||0.7||||||||0.7||
74006889|NCT02748018|147563338|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.1||||||||0.1||
74006890|NCT02748018|147563339|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) during Night|Mean Difference (Final Values)|-0.7|||||ONE_SIDED|97.5||0.2||||||||0.2||
74006891|NCT02748018|147563340|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) during Night|Mean Difference (Final Values)|12.2|||||ONE_SIDED|97.5|8.3||||||||||8.3|
74006892|NCT02748018|147563341|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|6.3|||||ONE_SIDED|97.5|3.3||||||||||3.3|
74006893|NCT02748018|147563342|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-0.8|||||ONE_SIDED|97.5||-0.1||||||||-0.1||
74006894|NCT02748018|147563343|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.1||||||||0.1||
74038837|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.21|STANDARD_ERROR_OF_MEAN|4.91||0.073|TWO_SIDED|95.0|-24.88|-5.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.54|-24.88|0.073
74038838|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.69|STANDARD_ERROR_OF_MEAN|5.21||0.027|TWO_SIDED|95.0|-24.97|-4.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.42|-24.97|0.027
74038839|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.44|STANDARD_ERROR_OF_MEAN|4.82||1|TWO_SIDED|95.0|-9.94|9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.05|-9.94|1.00
74038840|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.25|STANDARD_ERROR_OF_MEAN|5.28||0.62|TWO_SIDED|95.0|-10.66|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.16|-10.66|0.62
74038841|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.07|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-34.64|-15.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-15.50|-34.64|<0.001
74038842|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.79|STANDARD_ERROR_OF_MEAN|5.58||0.007|TWO_SIDED|95.0|-30.81|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.77|-30.81|0.007
74038843|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.15|STANDARD_ERROR_OF_MEAN|4.61||0.005|TWO_SIDED|95.0|-25.27|-7.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-7.03|-25.27|0.005
74038844|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.18|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|95.0|-32.11|-14.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.25|-32.11|<0.001
74038845|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.21|STANDARD_ERROR_OF_MEAN|4.95|<|0.001|TWO_SIDED|95.0|-33.0|-13.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.43|-33.00|<0.001
74038846|NCT01763866|147630770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.87|STANDARD_ERROR_OF_MEAN|5.43|<|0.001|TWO_SIDED|95.0|-43.6|-22.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-22.14|-43.60|<0.001
74038847|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.47|STANDARD_ERROR_OF_MEAN|4.92||0.088|TWO_SIDED|95.0|-24.16|-4.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.78|-24.16|0.088
74038848|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.47|STANDARD_ERROR_OF_MEAN|7.22||0.005|TWO_SIDED|95.0|-40.71|-12.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-12.24|-40.71|0.005
74038849|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.54|STANDARD_ERROR_OF_MEAN|5.0||1|TWO_SIDED|95.0|-11.41|8.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.32|-11.41|1.00
73878491|NCT05051579|147296575|OTHER||LS Mean difference (Final Values)|-3.5|||<|0.001|TWO_SIDED|95.0|-4.3|-2.6|||Mixed Models Analysis|||||-2.6|-4.3|<0.001
74038850|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.19|STANDARD_ERROR_OF_MEAN|7.21||0.056|TWO_SIDED|95.0|-29.4|-0.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-0.97|-29.40|0.056
74038851|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.42|STANDARD_ERROR_OF_MEAN|5.39||0.073|TWO_SIDED|95.0|-27.05|-5.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.80|-27.05|0.073
74038852|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-9.6|STANDARD_ERROR_OF_MEAN|6.13||0.027|TWO_SIDED|95.0|-21.68|2.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||2.48|-21.68|0.027
74038853|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.78|STANDARD_ERROR_OF_MEAN|5.27||1|TWO_SIDED|95.0|-12.16|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.61|-12.16|1.00
74038854|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.94|STANDARD_ERROR_OF_MEAN|6.18||0.62|TWO_SIDED|95.0|-7.25|17.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||17.14|-7.25|0.62
74038855|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.98|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-34.24|-9.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.73|-34.24|<0.001
74038856|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.75|STANDARD_ERROR_OF_MEAN|6.5||0.007|TWO_SIDED|95.0|-31.6|-5.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.90|-31.60|0.007
74038857|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.19|STANDARD_ERROR_OF_MEAN|5.7||0.005|TWO_SIDED|95.0|-27.46|-4.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.92|-27.46|0.005
74038858|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.54|STANDARD_ERROR_OF_MEAN|5.31|<|0.001|TWO_SIDED|95.0|-29.04|-8.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.05|-29.04|<0.001
74038859|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.45|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-33.09|-11.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.81|-33.09|<0.001
74038860|NCT01763866|147630771|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.83|STANDARD_ERROR_OF_MEAN|6.14|<|0.001|TWO_SIDED|95.0|-48.96|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-24.70|-48.96|<0.001
74038861|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.53|STANDARD_ERROR_OF_MEAN|1.84||0.034|TWO_SIDED|95.0|2.91|10.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.15|2.91|0.034
74038862|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.11|STANDARD_ERROR_OF_MEAN|2.37||0.017|TWO_SIDED|95.0|3.43|12.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.79|3.43|0.017
74038863|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.67|STANDARD_ERROR_OF_MEAN|1.86||0.001|TWO_SIDED|95.0|3.0|10.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.34|3.00|0.001
74038864|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.57|STANDARD_ERROR_OF_MEAN|2.36||0.006|TWO_SIDED|95.0|3.93|13.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.22|3.93|0.006
74038865|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.95|STANDARD_ERROR_OF_MEAN|2.1||0.85|TWO_SIDED|95.0|-0.19|8.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.09|-0.19|0.85
74091214|NCT01663727|147736225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0101|TWO_SIDED|96.0|0.5|0.93|||Log Rank|||Unstratified analysis.||0.93|0.50|0.0101
74091215|NCT01663727|147736226|SUPERIORITY_OR_OTHER||Difference in Response Rates|21.53||||0.0017|TWO_SIDED|95.0|8.73|34.32|||Fisher|||||34.32|8.73|0.0017
73878492|NCT05051579|147296575|OTHER||LS Mean difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-4.6|3.0|||Mixed Models Analysis|||||3.0|-4.6|<0.001
73878493|NCT05051579|147296575|OTHER||LS Mean difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-4.7|-3.1|||Mixed Models Analysis|||||-3.1|-4.7|<0.001
73878494|NCT05051579|147296576|OTHER||LS Mean difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.6|-1.5|||Mixed Models Analysis|||||-1.5|-3.6|<0.001
73878495|NCT05051579|147296576|OTHER||LS Mean difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-4.8|-2.8|||Mixed Models Analysis|||||-2.8|-4.8|<0.001
73878496|NCT05051579|147296576|OTHER||LS Mean difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.2|-3.2|||Mixed Models Analysis|||||-3.2|-5.2|<0.001
73957385|NCT01651949|147450895|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-19.1|||<|0.001|TWO_SIDED|95.0|-22.5|-15.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Pain||-15.7|-22.5|<0.001
74091216|NCT01663727|147736227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2737|TWO_SIDED|95.0|0.54|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.19|0.54|0.2737
73878497|NCT05051579|147296576|OTHER||LS Mean difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-5.6|-3.6|||Mixed Models Analysis|||||-3.6|-5.6|<0.001
73878498|NCT05051579|147296577|OTHER||Odds Ratio (OR)|9.96|||<|0.001|TWO_SIDED|95.0|3.61|27.44|||Regression, Logistic|||||27.44|3.61|<0.001
73878499|NCT05051579|147296577|OTHER||Odds Ratio (OR)|27.97|||<|0.001|TWO_SIDED|95.0|8.15|96.01|||Regression, Logistic|||||96.01|8.15|<0.001
73878500|NCT05051579|147296577|OTHER||Odds Ratio (OR)|27.36|||<|0.001|TWO_SIDED|95.0|8.71|85.91|||Regression, Logistic|||||85.91|8.71|<0.001
73878501|NCT05051579|147296577|OTHER||Odds Ratio (OR)|23.59|||<|0.001|TWO_SIDED|95.0|7.65|72.77|||Regression, Logistic|||||72.77|7.65|<0.001
73878502|NCT05051579|147296578|OTHER||Odds Ratio (OR)|19.93|||<|0.001|TWO_SIDED|95.0|3.47|114.4|||Regression, Logistic|||||114.40|3.47|<0.001
73878503|NCT05051579|147296578|OTHER||Odds Ratio (OR)|39.52|||<|0.001|TWO_SIDED|95.0|6.95|224.83|||Regression, Logistic|||||224.83|6.95|<0.001
73878504|NCT05051579|147296578|OTHER||Odds Ratio (OR)|74.97|||<|0.001|TWO_SIDED|95.0|13.16|427.18|||Regression, Logistic|||||427.18|13.16|<0.001
73878505|NCT05051579|147296578|OTHER||Odds Ratio (OR)|72.23|||<|0.001|TWO_SIDED|95.0|12.62|413.21|||Regression, Logistic|||||413.21|12.62|<0.001
73878506|NCT05051579|147296579|OTHER||Odds Ratio (OR)|7.79|||<|0.001|TWO_SIDED|95.0|2.9|20.92|||Regression, Logistic|||||20.92|2.90|<0.001
73878507|NCT05051579|147296579|OTHER||Odds Ratio (OR)|25.07|||<|0.001|TWO_SIDED|95.0|7.49|83.91|||Regression, Logistic|||||83.91|7.49|<0.001
73878508|NCT05051579|147296579|OTHER||Odds Ratio (OR)|34.76|||<|0.001|TWO_SIDED|95.0|8.17|147.86|||Regression, Logistic|||||147.86|8.17|<0.001
73878509|NCT05051579|147296579|OTHER||Odds Ratio (OR)|28.01|||<|0.001|TWO_SIDED|95.0|8.15|96.29|||Regression, Logistic|||||96.29|8.15|<0.001
73878510|NCT05051579|147296580|OTHER||Odds Ratio (OR)|8.27|||<|0.001|TWO_SIDED|95.0|2.59|26.45|||Regression, Logistic|||||26.45|2.59|<0.001
73878511|NCT05051579|147296580|OTHER||Odds Ratio (OR)|15.64|||<|0.001|TWO_SIDED|95.0|4.83|50.68|||Regression, Logistic|||||50.68|4.83|<0.001
73878512|NCT05051579|147296580|OTHER||Odds Ratio (OR)|27.24|||<|0.001|TWO_SIDED|95.0|8.39|88.38|||Regression, Logistic|||||88.38|8.39|<0.001
73878513|NCT05051579|147296580|OTHER||Odds Ratio (OR)|20.88|||<|0.001|TWO_SIDED|95.0|6.59|66.17|||Regression, Logistic|||||66.17|6.59|<0.001
73878514|NCT03062358|147296638|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.018|TWO_SIDED|95.0|0.63|0.99||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.99|0.63|0.0180
74006895|NCT00537485|147563344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|-3.7|1.1|||t-test, 2 sided|||||1.1|-3.7|0.002
74006896|NCT00537485|147563345|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.7|||<|0.001|TWO_SIDED|95.0|16.7|44.6|||Chi-squared, Corrected|||||44.6|16.7|<0.001
74006897|NCT00537485|147563345|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.1|||<|0.001|TWO_SIDED|95.0|12.0|40.2|||Chi-squared, Corrected|||||40.2|12.0|<0.001
74006898|NCT05341700|147563354|SUPERIORITY|||||||0.246|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of PINP between RUN and RUN+J.||||0.246
74006899|NCT05341700|147563355|SUPERIORITY|||||||0.714|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of CTX between RUN and RUN+J.||||0.714
74006900|NCT05341700|147563356|SUPERIORITY|||||||0.309|||||||Mixed Models Analysis|||||||0.309
74006901|NCT05341700|147563357|SUPERIORITY|||||||0.308|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of IGF1 between RUN and RUN+J.||||0.308
74006902|NCT05341700|147563358|SUPERIORITY|||||||0.207|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of ferritin between RUN and RUN+J.||||0.207
74006903|NCT00312221|147563359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.126|TWO_SIDED|95.0|-0.8562|0.1054|||Mixed Models Analysis||Treatment comparison between BTDS 20 and BTDS 5 during the 12-week double-blind phase|||0.1054|-0.8562|0.126
74006904|NCT00312221|147563359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.14||95.0|-0.8455|0.1189|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||0.1189|-0.8455|0.140
74006905|NCT00312221|147563360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.007|TWO_SIDED|95.0|-1.47|-0.2|||ANCOVA||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||-0.20|-1.47|0.007
74006906|NCT00312221|147563360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.011|TWO_SIDED|95.0|-1.47|-0.17|||ANCOVA||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||-0.17|-1.47|0.011
74091217|NCT01663727|147736227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.2959|TWO_SIDED|95.0|0.56|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.19|0.56|0.2959
74091218|NCT01663727|147736228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.1783|TWO_SIDED|95.0|0.41|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.18|0.41|0.1783
74091219|NCT01663727|147736228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2429|TWO_SIDED|95.0|0.45|1.22|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.22|0.45|0.2429
74091220|NCT01232491|147736235|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.49||||0.132||95.0|-0.15|1.13||If the p-value for the two-sided test was less than 5%, and D (the estimated treatment difference \[dietary intervention versus no dietary intervention\]) was less than 0 then superiority for dietary intervention was considered confirmed.|Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening, sex and region as factors and age and weight at baseline as covariates. Superiority was considered confirmed if the upper bound of the two-sided 95% CI for the estimated treatment difference (dietary intervention versus no dietary intervention), which was calculated using the FAS, was below 0 kg.||1.13|-0.15|0.132
74091221|NCT01232491|147736236|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.17||||0.137||95.0|-0.05|0.39|||Regression, Linear|||Normal linear regression model with treatment, use of insulin secretagogue at screening, sex and region as factors, and age and BMI at baseline as covariates.||0.39|-0.05|0.137
74091222|NCT01232491|147736237|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.13||||0.053||95.0|0.0|0.26|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and HbA1c at baseline as covariate.||0.26|-0.00|0.053
74091223|NCT01232491|147736238|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.07||||0.674||95.0|-0.25|0.39|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and FPG at baseline as covariate.||0.39|-0.25|0.674
74091224|NCT00586482|147736244|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||A two-sided p value of less than or equal to 0.05 was considered statistically significant.||||0.12
74091225|NCT00586482|147736245|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||0.23
74091226|NCT00586482|147736246|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
74091227|NCT00586482|147736247|SUPERIORITY_OR_OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
74091228|NCT00586482|147736248|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
74091229|NCT06204887|147736275|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
74091230|NCT02072824|147736336|SUPERIORITY||Least Square Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4606|TWO_SIDED|95.0|-0.19|0.42|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.||0.42|-0.19|0.4606
74091231|NCT02072824|147736336|SUPERIORITY||Least Square Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.185||0.0223|TWO_SIDED|95.0|-0.8|-0.06|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.||-0.06|-0.80|0.0223
74091232|NCT02072824|147736337|SUPERIORITY||Odds Ratio (OR)|0.625||||0.2418|TWO_SIDED|95.0|0.284|1.373|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.||1.373|0.284|0.2418
74091233|NCT02072824|147736337|SUPERIORITY||Odds Ratio (OR)|1.622||||0.305|TWO_SIDED|95.0|0.644|4.086|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.||4.086|0.644|0.3050
74091234|NCT00841906|147736358|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
74091235|NCT00903448|147736362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0||||The least squares treatment means, i.e. adjusted treatment means, and standard errors were computed from the analysis of variance models.|Mixed Models Analysis|||This study enrolled 40 subjects in order to complete a target of at least 30 evaluable subjects. For the purpose of determination of sample size, it was assumed that at least 30 subjects would have complete data for all 3 treatment periods. Assuming the true mean difference in % time that gastric pH \> 4.0 between Prilosec OTC and Prevacid was at least 6.5, it was estimated that there would be at least 80% power to detect a treatment difference in 2-sided testing at the 5% significance level.||||< 0.0001
74091236|NCT01196078|147736365|SUPERIORITY_OR_OTHER||Difference in Percentages|13.88||||0.0388|TWO_SIDED|95.0|-0.22|26.19||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, Eastern Cooperative Oncology Group \[ECOG\] status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% confidence interval (CI) for the difference in tumor response rate determined using Hauck-Anderson approach.|||26.19|-0.22|0.0388
74091237|NCT01196078|147736366|SUPERIORITY_OR_OTHER||Difference in Percentages|14.79||||0.1061|TWO_SIDED|95.0|-3.54|31.33||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, ECOG status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% CI for the difference in the disease control rate determined using Hauck-Anderson approach.|||31.33|-3.54|0.1061
74091238|NCT01196078|147736367|SUPERIORITY_OR_OTHER|||||||0.9505|||||||Log Rank|||||||0.9505
74091239|NCT01196078|147736369|SUPERIORITY_OR_OTHER|||||||0.2314|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.||||||0.2314
74091240|NCT01196078|147736371|SUPERIORITY_OR_OTHER|||||||0.9894|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.||||||0.9894
74091241|NCT01196078|147736373|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||PWB, Baseline versus Endpoint||||0.0060
74091242|NCT01196078|147736373|SUPERIORITY_OR_OTHER|||||||0.6871|||||||ANOVA|||SWB, Baseline versus Endpoint||||0.6871
73878515|NCT03062358|147296639|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0032|TWO_SIDED|95.0|0.6|0.92||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.92|0.60|0.0032
73878516|NCT03062358|147296640|OTHER||Percent Difference|11.4||||4e-05|TWO_SIDED|95.0|6.7|16.0|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|Difference in % vs Placebo|Difference in % vs Placebo|Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. \>= 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|16.0|6.7|0.00004
73878517|NCT03062358|147296642|OTHER||Percent Difference|5.4||||0.13281|TWO_SIDED|95.0|-4.1|14.8|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|Difference in % vs Placebo|Difference in % vs Placebo|Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|14.8|-4.1|0.13281
73878518|NCT03062358|147296643|OTHER||Hazard Ratio (HR)|0.72||||0.0019|TWO_SIDED|95.0|0.58|0.9||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.90|0.58|0.0019
73878519|NCT03861273|147296646|NON_INFERIORITY|A repeated measure negative binomial regression model was used to do the hypothesis test on non-inferiority with one-sided test.|Mean Difference (Final Values)|-3.13||||0.0081|TWO_SIDED|95.0|-5.44|-0.81|||Generalized linear model (GLM)|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.||||-0.81|-5.44|0.0081
73878520|NCT03861273|147296647|NON_INFERIORITY|A repeated measure negative binomial regression model was used to do the hypothesis test on non-inferiority with one-sided test.|Median Difference (Final Values)|-2.62||||0.0019|TWO_SIDED|95.0|-4.27|-0.96|||Generalized linear model (GLM)|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.||||-0.96|-4.27|0.0019
73957386|NCT01651949|147450895|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-17.3|||<|0.001|TWO_SIDED|95.0|-20.8|-13.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Swelling||-13.7|-20.8|<0.001
74038866|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.13|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|4.68|13.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.58|4.68|<0.001
74038867|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.57|STANDARD_ERROR_OF_MEAN|2.06||0.003|TWO_SIDED|95.0|3.51|11.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.64|3.51|0.003
74091243|NCT01196078|147736373|SUPERIORITY_OR_OTHER|||||||0.5104|||||||ANOVA|||EWB Baseline versus Endpoint||||0.5104
74091244|NCT01196078|147736373|SUPERIORITY_OR_OTHER|||||||0.9927|||||||ANOVA|||FWB, Baseline versus Endpoint||||0.9927
74091245|NCT01196078|147736373|SUPERIORITY_OR_OTHER|||||||0.3581|||||||ANOVA|||LCS, Baseline versus Endpoint||||0.3581
73878521|NCT03861273|147296648|SUPERIORITY||Mean Difference (Final Values)|-54.37|||<|0.0001|TWO_SIDED|95.0|-63.64|-45.1|||Paired t-test|||The treatment difference (PF-06838435 - FIX Prophylaxis) estimate (95% CI) and p-value were obtained from paired t-test.||-45.10|-63.64|<.0001
73878522|NCT03861273|147296649|OTHER||||||<|0.0001||||||P-value from one-sided t-statistic testing the log transformation of the steady state FIX:C \> log(5). Cumulative for 3 assays.|One-sided t-statistic testing|||Week 12 to Month 15||||<.0001
73878523|NCT03861273|147296651|SUPERIORITY||Mean Difference (Final Values)|-2935.7|||<|0.0001|TWO_SIDED|95.0|-3403.1|-2468.3|||Paired t-test|||||-2468.30|-3403.10|<.0001
73878524|NCT03861273|147296652|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Mean Difference (Final Values)|-2.55||||0.0191|TWO_SIDED|95.0|-4.67|-0.42|||Generalized linear model (GLM)|||||-0.42|-4.67|0.0191
73878525|NCT03861273|147296653|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Median Difference (Final Values)|-0.57||||0.1528|TWO_SIDED|95.0|-1.35|0.21|||Generalized linear model (GLM)|||||0.21|-1.35|0.1528
73878526|NCT03861273|147296654|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Mean Difference (Final Values)|-0.51||||0.3738|TWO_SIDED|95.0|-1.63|0.61|||Generalized linear model (GLM)|||||0.61|-1.63|0.3738
73878527|NCT03861273|147296657|OTHER|||||||0.0117|||||||Paired t-test|||||||0.0117
73878528|NCT03861273|147296658|OTHER|||||||0.0052|||||||Paired t-test|||||||0.0052
73878529|NCT03861273|147296659|OTHER|||||||0.0237|||||||Paired t-test|||||||0.0237
73878530|NCT03799341|147296673|OTHER|||||||0.177|||||||Wilcoxon (Mann-Whitney)|||||||0.177
73878531|NCT03799341|147296674|OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
73878532|NCT03799341|147296675|OTHER|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
73878533|NCT03799341|147296676|OTHER|||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
73878534|NCT03799341|147296677|OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
73878535|NCT03799341|147296678|OTHER|||||||0.976|||||||Wilcoxon (Mann-Whitney)|||||||0.976
73878536|NCT03799341|147296679|OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.920
73878537|NCT03799341|147296680|OTHER|||||||0.873|||||||Wilcoxon (Mann-Whitney)|||||||0.873
73878538|NCT03799341|147296681|OTHER||||||<|0.001|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the influence of Contingency Management session attendance. The design included 4 factors: time (2 levels), stimulus condition (3 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||<0.001
73878539|NCT03799341|147296681|OTHER||||||<|0.001|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit covariates. A median split approach was therefore used to examine the influence of self-reported cocaine abstinence during treatment. The design included 4 factors: time (2 levels), stimulus condition (3 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||<0.001
73878540|NCT03799341|147296681|OTHER|||||||0.022|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the influence of Contingency Management session attendance. The design included 4 factors: time (2 levels), response accuracy (2 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.022
73878541|NCT03799341|147296681|OTHER|||||||0.024|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit covariates. A median split approach was therefore used to examine the influence of self-reported cocaine abstinence during treatment. The design included 4 factors: time (2 levels), response accuracy (2 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.024
74091246|NCT00270257|147736397|SUPERIORITY_OR_OTHER_LEGACY||Incident rate per 100 person-years|1.5|||||TWO_SIDED|95.0|0.7|2.8||||||||2.8|0.7|
74091247|NCT00270257|147736397|SUPERIORITY_OR_OTHER_LEGACY||Incident rate per 100 person-years|2.2|||||TWO_SIDED|95.0|1.2|3.7||||||||3.7|1.2|
74091248|NCT00270257|147736397|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.694||||0.3769|TWO_SIDED|95.0|0.308|1.562|||Regression, Cox|||||1.562|0.308|0.3769
73878542|NCT03799341|147296682|OTHER|||||||0.973|||||||ANOVA|||No violations of normality assumptions were identified. A repeated measures ANOVA was conducted. To maintain consistency with other outcome measures, a median split approach was used to examine the potential influence of Contingency Management session attendance. The design included two factors: time (2 levels) and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.973
73878543|NCT03799341|147296682|OTHER|||||||0.662|||||||ANOVA|||No violations of normality assumptions were identified. A repeated measures ANOVA was conducted. To maintain consistency with other outcome measures, a median split approach was used to examine the potential influence of self-reported cocaine abstinence during the 12-week treatment interval. The design included two factors: time (2 levels) and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.662
74006907|NCT00312221|147563361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.707|TWO_SIDED|95.0|-3.0054|2.0397|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||2.0397|-3.0054|0.707
74006908|NCT00312221|147563361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79||||0.187|TWO_SIDED|95.0|-4.4459|0.8706|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||0.8706|-4.4459|0.187
74006909|NCT00312221|147563362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.685|TWO_SIDED|95.0|-5.6177|3.693|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||3.6930|-5.6177|0.685
74006910|NCT00312221|147563362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81||||0.443|TWO_SIDED|95.0|-6.4415|2.8255|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||2.8255|-6.4415|0.443
74006911|NCT01807923|147563366|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|4.03|||<|0.0001|TWO_SIDED|95.0|2.62|5.44|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than (\<)18 versus greater than equal to (\>=18) years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||5.44|2.62|<0.0001
74006912|NCT01807923|147563366|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.0003|TWO_SIDED|95.0|1.18|4.01|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.01|1.18|0.0003
74006913|NCT01807923|147563367|SUPERIORITY_OR_OTHER||LS Mean Difference|6.73|||<|0.0001|TWO_SIDED|95.0|4.27|9.19|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||9.19|4.27|<0.0001
74006914|NCT01807923|147563367|SUPERIORITY_OR_OTHER||LS Mean Difference|4.33||||0.0006|TWO_SIDED|95.0|1.86|6.8|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||6.80|1.86|0.0006
74006915|NCT01807923|147563368|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.1122|TWO_SIDED|95.0|-0.04|0.35|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI.||0.35|-0.04|0.1122
74006916|NCT01807923|147563368|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.1938|TWO_SIDED|95.0|-0.07|0.32|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||0.32|-0.07|0.1938
74006917|NCT01807923|147563369|SUPERIORITY_OR_OTHER||LS Mean Difference|3.88||||0.0168|TWO_SIDED|95.0|0.7|7.05||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline CFQ-R respiratory domain score.||7.05|0.70|0.0168
74091249|NCT00270257|147736398|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.844||||0.4325|TWO_SIDED|95.0|0.553|1.289||P value applies for the comparison at visit 104.|Regression, Logistic|adjusted for site||||1.289|0.553|0.4325
74091250|NCT00270257|147736399|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8||||0.2749|TWO_SIDED|95.0|0.536|1.194||P value applies for the comparison at visit 104 only.|Regression, Logistic|||||1.194|0.536|0.2749
74091251|NCT00270257|147736400|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.746||||0.3446|TWO_SIDED|95.0|0.407|1.369||Analysis is done for visit 104|Regression, Logistic|Adjusted for site||||1.369|0.407|0.3446
74091252|NCT00270257|147736401|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8712||||0.362|TWO_SIDED|95.0|0.6477|1.1718||P value applies for the comparison at visit 104 only. See the estimation comments for the other visits|Generalized linear model|adjusted for site.||||1.1718|0.6477|0.3620
74091253|NCT00270257|147736402|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|22.0|||||TWO_SIDED|95.0|14.7|31.6|||||29 events over 132 person-years|||31.6|14.7|
74091254|NCT00270257|147736402|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|4.59|||||TWO_SIDED|95.0|2.0|9.0|||||8 events over 174 person-years|||9.0|2.0|
74038868|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.35|STANDARD_ERROR_OF_MEAN|2.28||0.003|TWO_SIDED|95.0|3.86|12.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.84|3.86|0.003
74038869|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.36|STANDARD_ERROR_OF_MEAN|1.87|<|0.001|TWO_SIDED|95.0|1.68|9.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.04|1.68|<0.001
74038870|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.66|STANDARD_ERROR_OF_MEAN|3.11||0.01|TWO_SIDED|95.0|2.51|14.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||14.80|2.51|0.010
74038871|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.46|STANDARD_ERROR_OF_MEAN|1.91||0.013|TWO_SIDED|95.0|1.69|9.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.23|1.69|0.013
74038872|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.75|STANDARD_ERROR_OF_MEAN|2.2||0.002|TWO_SIDED|95.0|2.4|11.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.10|2.40|0.002
74038873|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|10.23|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|5.13|15.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||15.32|5.13|<0.001
74038874|NCT01763866|147630772|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.85|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|4.73|12.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||12.97|4.73|<0.001
74038875|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.83|STANDARD_ERROR_OF_MEAN|2.11||0.034|TWO_SIDED|95.0|2.66|10.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.99|2.66|0.034
74091255|NCT00270257|147736403|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|2.7|||||TWO_SIDED|95.0|1.22|5.08|||||9 events over 336 person-years|||5.08|1.22|
74091256|NCT00270257|147736403|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|0.0|||||TWO_SIDED|95.0|0.0|10.1|||||0 events over 37 person-years|||10.1|0.00|
74091257|NCT04688931|147736442|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.45|||||TWO_SIDED|95.0|0.29|0.68|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.68|0.29|
74091258|NCT04688931|147736443|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.46|||||TWO_SIDED|95.0|0.3|0.7|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.70|0.30|
74091259|NCT04688931|147736445|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.46|||||TWO_SIDED|95.0|0.24|0.86|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.86|0.24|
74091260|NCT00450619|147736453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5019||||0.041|TWO_SIDED|95.0|||||Log Rank|||||||0.041
74091261|NCT00450619|147736453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5019||||0.046|TWO_SIDED|95.0|||||Hazard Ratio|||||||0.046
74091262|NCT00450619|147736457|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.3|TWO_SIDED|95.0|0.37|1.35|||Kaplan Meier|||||1.35|0.37|0.30
73878544|NCT03799341|147296683|OTHER|||||||0.878|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the potential influence of Contingency Management session attendance. The design included 3 factors: time (2 levels), condition (2 levels), and median split group membership (2 levels). Reported results reflect the interaction between time, condition, and median split group.||||0.878
73878545|NCT03799341|147296683|OTHER|||||||0.645|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the potential influence of self-reported cocaine abstinence during treatment. The design included 3 factors: time (2 levels), condition (2 levels), and median split group membership (2 levels). Reported results reflect the interaction between time, condition, and median split group.||||0.645
74038876|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.87|STANDARD_ERROR_OF_MEAN|2.46||0.017|TWO_SIDED|95.0|3.01|12.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.73|3.01|0.017
74038877|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.81|STANDARD_ERROR_OF_MEAN|2.14||0.001|TWO_SIDED|95.0|4.58|13.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.03|4.58|0.001
74038878|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.28|STANDARD_ERROR_OF_MEAN|2.45||0.006|TWO_SIDED|95.0|3.46|13.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.11|3.46|0.006
74038879|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.07|STANDARD_ERROR_OF_MEAN|2.28||0.85|TWO_SIDED|95.0|-0.42|8.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.57|-0.42|0.85
74038880|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.05|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|2.22|11.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.89|2.22|<0.001
74038881|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.47|STANDARD_ERROR_OF_MEAN|2.23||0.003|TWO_SIDED|95.0|4.07|12.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.87|4.07|0.003
74038882|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.14|STANDARD_ERROR_OF_MEAN|2.46||0.003|TWO_SIDED|95.0|2.29|11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.99|2.29|0.003
74038883|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.2|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-1.33|7.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.73|-1.33|<0.001
74038884|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.35|STANDARD_ERROR_OF_MEAN|3.23||0.01|TWO_SIDED|95.0|0.97|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.72|0.97|0.010
74038885|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.04|STANDARD_ERROR_OF_MEAN|2.29||0.013|TWO_SIDED|95.0|0.52|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.56|0.52|0.013
74038886|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.84|STANDARD_ERROR_OF_MEAN|2.41||0.002|TWO_SIDED|95.0|0.07|9.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.60|0.07|0.002
74091263|NCT00714493|147736473|SUPERIORITY_OR_OTHER||change from baseline||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
74091264|NCT00714493|147736474|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
73878546|NCT01116648|147296684|OTHER||Maximum Tolerated Dose (mg)|30.0|||||TWO_SIDED||||||||Cediranib|||||
73878547|NCT01116648|147296684|OTHER||Maximum Tolerated Dose (mg BID)|200.0|||||TWO_SIDED||||||||Olaparib|||||
73878548|NCT01116648|147296686|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.006|TWO_SIDED|95.0|0.3|0.83|||Kaplan-Meier Plot|||||0.83|0.30|0.006
73878549|NCT01650194|147296712|OTHER|||||||0.615|||||||t-test, 2 sided|||Testosterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||0.6150
73878550|NCT01650194|147296714|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Cortisol biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
74091265|NCT00251719|147736484|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|2.34||||0.234||95.0|-1.45|6.14||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||6.14|-1.45|0.234
74091266|NCT00251719|147736484|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|4.85||||0.019||95.0|1.2|8.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||8.50|1.20|0.019
74091267|NCT00251719|147736484|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.220
74091268|NCT00251719|147736485|SUPERIORITY_OR_OTHER|||||||0.768||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.768
74091269|NCT00251719|147736485|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.064
74091270|NCT00251719|147736485|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.034
74091271|NCT00251719|147736486|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.727
74091272|NCT00251719|147736486|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.064
74091273|NCT00251719|147736486|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.174
74091274|NCT00251719|147736487|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|1.65||||0.167||95.0|-1.65|4.96||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||4.96|-1.65|0.167
73878551|NCT01650194|147296715|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
74091275|NCT00251719|147736487|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|3.39||||0.03||95.0|0.27|6.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||6.50|0.27|0.030
73878552|NCT01650194|147296716|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Progesterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
73878553|NCT01650194|147296717|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
74091276|NCT00251719|147736487|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.413
74091277|NCT00251719|147736488|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.100
74091278|NCT00251719|147736488|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.125
74091279|NCT00251719|147736488|SUPERIORITY_OR_OTHER|||||||0.993||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.993
74091280|NCT00251719|147736489|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.117
74091281|NCT00251719|147736489|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.124
73878554|NCT01650194|147296718|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Testosterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
74091282|NCT00251719|147736489|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.949
74091283|NCT00688376|147736495|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.8||||0.694|TWO_SIDED|95.0|-3.22|4.8|||ANCOVA|||P-values, least squares (LS) mean, and 95% confidence interval (CI) were obtained from Analysis of Covariance (ANCOVA) model with treatment group as a factor and Baseline value as covariate.||4.8|-3.22|0.694
73878555|NCT01650194|147296720|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Cortisol blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
73878556|NCT01650194|147296721|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
73878557|NCT01650194|147296722|OTHER|||||||0.0002|||||||t-test, 2 sided|||Progesterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||0.0002
73878558|NCT01650194|147296723|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
73878559|NCT00880698|147296737|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.1||||0.62|TWO_SIDED|95.0|-20.6|14.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-uninfected participants experiencing a new grade \>=3 adverse event|||14.8|-20.6|0.62
73957387|NCT01651949|147450896|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.5||||0.091|TWO_SIDED|95.0|-3.4|0.2|||Miettinen & Nurminen||The incidence of maximum body temperature \>=37.8° C reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Elevated Body Temperature||0.2|-3.4|0.091
73957388|NCT01651949|147450897|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.7|0.9|||Miettinen & Nurminen|||Anti-HPV Type 6||0.9|-0.7|<0.001
74006918|NCT01807923|147563369|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.3569|TWO_SIDED|95.0|-1.69|4.69|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.69|-1.69|0.3569
73878560|NCT00880698|147296737|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.7||||1|TWO_SIDED|95.0|-21.0|23.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-infected participants experiencing a new grade \>=3 adverse event|||23.4|-21.0|1.00
73878561|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|29.9|||<|0.001|TWO_SIDED|95.0|11.5|46.1||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1||46.1|11.5|<0.001
73878562|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|49.8|||<|0.001|TWO_SIDED|95.0|27.1|68.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1||68.6|27.1|<0.001
73878563|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.1||||0.2|TWO_SIDED|95.0|-11.3|24.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2||24.8|-11.3|0.20
73878564|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.2||||0.19|TWO_SIDED|95.0|-10.6|36.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2||36.7|-10.6|0.19
73878565|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.3|||<|0.001|TWO_SIDED|95.0|0.9|36.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3||36.4|0.9|<0.001
73957389|NCT01651949|147450897|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.8|||Miettinen & Nurminen|||Anti-HPV Type 11||0.8|-0.3|<0.001
73957390|NCT01651949|147450897|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 16||0.7|-0.3|<0.001
73957391|NCT01651949|147450897|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.4|0.8|||Miettinen & Nurminen|||Anti-HPV Type 18||0.8|-0.4|<0.001
73957392|NCT01651949|147450897|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-0.4|0.5|||Miettinen & Nurminen|||Anti-HPV Type 31||0.5|-0.4|<0.001
73957393|NCT01651949|147450897|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 33||0.7|-0.3|<0.001
73878566|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|29.4|||<|0.001|TWO_SIDED|95.0|4.7|50.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3||50.6|4.7|<0.001
74006919|NCT01807923|147563370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9378|||<|0.0001|TWO_SIDED|95.0|1.8786|4.5941||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.5941|1.8786|<0.0001
74006920|NCT01807923|147563370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0592||||0.0023|TWO_SIDED|95.0|1.292|3.2819||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||3.2819|1.2920|0.0023
74006921|NCT01807923|147563371|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.7186||||0.0491|TWO_SIDED|95.0|0.517|0.9987|||Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70) as covariates with the logarithm of time on study as the offset.||0.9987|0.5170|0.0491
74006922|NCT01807923|147563371|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.6643||||0.0169|TWO_SIDED|95.0|0.4749|0.9291||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.||0.9291|0.4749|0.0169
74006923|NCT01807923|147563372|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.1565|TWO_SIDED|95.0|-0.16|0.96|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline weight.||0.96|-0.16|0.1565
74006924|NCT01807923|147563372|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.2992|TWO_SIDED|95.0|-0.26|0.86|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.86|-0.26|0.2992
74006925|NCT01807923|147563373|SUPERIORITY_OR_OTHER||LS Mean Difference|0.098||||0.1539|TWO_SIDED|95.0|-0.037|0.233|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI z-score.||0.2330|-0.0370|0.1539
74006926|NCT01807923|147563373|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0781||||0.2713|TWO_SIDED|95.0|-0.0615|0.2176|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.2176|-0.0615|0.2713
74006927|NCT01807923|147563374|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.0396|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||||0.0396
74006928|NCT01807923|147563374|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||0.0385|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.||||0.0385
74006929|NCT01807923|147563375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6565||||0.0552|TWO_SIDED|95.0|0.4266|1.0103|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||1.0103|0.4266|0.0552
74006930|NCT01807923|147563375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6438||||0.0512|TWO_SIDED|95.0|0.4142|1.0005|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||1.0005|0.4142|0.0512
74006931|NCT01807923|147563376|SUPERIORITY_OR_OTHER||LS Mean Difference|0.006||||0.5604|TWO_SIDED|95.0|-0.0142|0.0262|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L index score.||0.0262|-0.0142|0.5604
74006932|NCT01807923|147563376|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0095||||0.3613|TWO_SIDED|95.0|-0.0109|0.0298|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.0298|-0.0109|0.3613
74006933|NCT01807923|147563377|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.1342|TWO_SIDED|95.0|-0.7|4.9|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L VAS score.||4.9|-0.7|0.1342
74006934|NCT01807923|147563377|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.3071|TWO_SIDED|95.0|-1.3|4.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||4.2|-1.3|0.3071
74006935|NCT01807923|147563378|SUPERIORITY_OR_OTHER||LS Mean Difference|5.49||||0.016|TWO_SIDED|95.0|1.03|9.96|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM effectiveness score.||9.96|1.03|0.0160
74006936|NCT01807923|147563378|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8||||0.0126|TWO_SIDED|95.0|1.25|10.35|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.||10.35|1.25|0.0126
74006937|NCT01807923|147563378|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.18||||0.0074|TWO_SIDED|95.0|-7.23|-1.13|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM side effects score.||-1.13|-7.23|0.0074
74006938|NCT01807923|147563378|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.74||||0.0029|TWO_SIDED|95.0|-7.85|-1.63|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.||-1.63|-7.85|0.0029
74091284|NCT00688376|147736496|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1||||0.9458|TWO_SIDED|95.0|-4.38|4.09|||ANCOVA|||P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.09|-4.38|0.9458
74006939|NCT01807923|147563378|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.7721|TWO_SIDED|95.0|-3.5|4.71|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM convenience score.||4.71|-3.50|0.7721
74006940|NCT01807923|147563378|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08||||0.1472|TWO_SIDED|95.0|-1.09|7.25|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.||7.25|-1.09|0.1472
74006941|NCT01807923|147563378|SUPERIORITY_OR_OTHER||LS Mean Difference|5.49||||0.0345|TWO_SIDED|95.0|0.4|10.58|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM global satisfaction score.||10.58|0.40|0.0345
74006942|NCT01807923|147563378|SUPERIORITY_OR_OTHER||LS Mean Difference|6.72||||0.0109|TWO_SIDED|95.0|1.55|11.89|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.||11.89|1.55|0.0109
74006943|NCT03531788|147563383|OTHER|||||||||||||||||Activity counts from the ActiGraph GT9x activity monitor provide data per participant during testing of upper extremity activities/tasks and were collected while wearing the device (Kinova and WREX) and without the device (Kinova and WREX). For each upper extremity task, we summed all activity count data for all tasks completed. We then computed means and standard deviations. Data presented are within group data change and not between group data comparisons.|Due to the small sample size, we utilized change in activity count data when comparing two upper limb testing sessions: one without the use of an arm support device (Kinova or WREX) and one while using the arm support device. For each upper extremity task, we summed all activity count data for all tasks completed. We then computed means and standard deviations. Data presented are within group data change and not between group data comparisons.|||
74006944|NCT03531788|147563384|OTHER|||||||||||||||||Activity counts from the ActiGraph GT9x activity monitor were collected during baseline (without a device) and throughout the 4 week device trial (with the device). For each time period, activity count data were averaged across the day. We then compared the baseline time period to the device trial period to understand the difference in movement and upper extremity positioning during the device trial. Data presented are within group change scores and not between group data comparisons.|Counts from each axis (x, y, z) were measured across baseline and during the 4-week trial to explore arm movement and positioning during the use of an upper extremity arm device. Counts (within each participant) were summed. A change score from trial minus baseline was calculated for each axis. We provide an average change score and standard deviation across participants with Kinova and participants with WREX.|||
74006945|NCT03531788|147563385|OTHER|||||||||||||||||Three goals were identified for each participant and scored without using an arm support device to serve as a baseline measure of abilities. These scores were compared to the scores achieved on the same goals using the arm support device.|We compared the change in GAS scores when using an arm support device on three goal areas identified as important for each participant. For each goal, we measured abilities at baseline and with the device (Kinova and WREX). We calculated the change in score for each goal and averaged these change scores across all participants. While our groups are too small to complete statistical tests to estimate the significance of the differences participants noted in activity and independence while using both arm supports, our results quantify the amount of increased success participants noted with the use of the arm support device.|||
74006946|NCT04427501|147563433|SUPERIORITY||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.15|0.58||||||||0.58|0.15|
74006947|NCT04427501|147563433|SUPERIORITY||Odds Ratio (OR)|0.12|||||TWO_SIDED|95.0|0.04|0.31||||||||0.31|0.04|
74006948|NCT04427501|147563434|SUPERIORITY||Odds Ratio (OR)|0.23|||||TWO_SIDED|95.0|0.13|0.4||||||||0.40|0.13|
74006949|NCT04427501|147563435|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.221||0.6921|TWO_SIDED|95.0|-0.35|0.52|||Mixed Models Analysis|||||0.52|-0.35|0.6921
74006950|NCT04427501|147563435|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.219||0.211|TWO_SIDED|95.0|-0.71|0.16|||Mixed Models Analysis|||||0.16|-0.71|0.2110
74006951|NCT04427501|147563435|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.225||0.163|TWO_SIDED|95.0|-0.13|0.76|||Mixed Models Analysis|||||0.76|-0.13|0.1630
74006952|NCT04427501|147563435|SUPERIORITY||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.22||0.0099|TWO_SIDED|95.0|-1.0|-0.14|||Mixed Models Analysis|||||-0.14|-1.00|0.0099
74006953|NCT04427501|147563440|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.13|1.86||||||||1.86|1.13|
74006954|NCT04427501|147563440|SUPERIORITY||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|1.24|1.95||||||||1.95|1.24|
74006955|NCT04427501|147563440|SUPERIORITY||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.06|2.53||||||||2.53|1.06|
74006956|NCT04427501|147563441|SUPERIORITY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.17|1.93||||||||1.93|1.17|
74006957|NCT04427501|147563441|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|1.33|2.09||||||||2.09|1.33|
74006958|NCT04427501|147563441|SUPERIORITY||Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.22|2.9||||||||2.9|1.22|
74006959|NCT04427501|147563442|SUPERIORITY||Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.18|0.64||||||||0.64|0.18|
74006960|NCT04427501|147563442|SUPERIORITY||Odds Ratio (OR)|0.17|||||TWO_SIDED|95.0|0.07|0.38||||||||0.38|0.07|
74006961|NCT04427501|147563442|SUPERIORITY||Odds Ratio (OR)|0.25|||||TWO_SIDED|95.0|0.06|1.05||||||||1.05|0.06|
74006962|NCT04427501|147563443|SUPERIORITY||Mean Difference (Net)|-1.2|||<|0|TWO_SIDED|95.0|-1.46|-0.94|||Mixed Models Analysis|||||-0.94|-1.46|<0.0000000
74006963|NCT04427501|147563443|SUPERIORITY||Mean Difference (Net)|-1.09|||<|0|TWO_SIDED|95.0|-1.34|-0.85|||Mixed Models Analysis|||||-0.85|-1.34|<0.0000000
74006964|NCT04427501|147563443|SUPERIORITY||Mean Difference (Net)|-0.99||||3.777e-05|TWO_SIDED|95.0|-1.45|-0.52|||Mixed Models Analysis|||||-0.52|-1.45|0.00003777
74006965|NCT04427501|147563444|SUPERIORITY||Hazard Ratio (HR)|1.213||||0.007|TWO_SIDED||||||Stratified Log-rank|||||||0.007
74006966|NCT04427501|147563444|SUPERIORITY||Hazard Ratio (HR)|1.111||||0.13|TWO_SIDED||||||Stratified Log-rank|||||||0.130
74006967|NCT04427501|147563444|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.012|TWO_SIDED||||||Stratified Log-rank|||||||0.012
74006968|NCT04427501|147563445|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.007|TWO_SIDED||||||Stratified Log-rank|||||||0.007
74006969|NCT04427501|147563445|SUPERIORITY||Hazard Ratio (HR)|1.237||||0.033|TWO_SIDED||||||Stratified Log-rank|||||||0.033
74006970|NCT04427501|147563445|SUPERIORITY||Hazard Ratio (HR)|1.521||||0.017|TWO_SIDED||||||Stratified Log-rank|||||||0.017
74006971|NCT04427501|147563446|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.243||0.499|TWO_SIDED|95.0|-0.31|0.64|||Mixed Models Analysis|||||0.64|-0.31|0.499
74006972|NCT04427501|147563446|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.241||0.492|TWO_SIDED|95.0|-0.64|0.31|||Mixed Models Analysis|||||0.31|-0.64|0.492
74006973|NCT04427501|147563446|SUPERIORITY||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.246||0.125|TWO_SIDED|95.0|-0.11|0.86|||Mixed Models Analysis|||||0.86|-0.11|0.125
74006974|NCT04427501|147563446|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.236||0.069|TWO_SIDED|95.0|-0.89|0.03|||Mixed Models Analysis|||||0.03|-0.89|0.069
74006975|NCT04427501|147563447|SUPERIORITY||Odds Ratio (OR)|1.74||||0.034|TWO_SIDED|95.0|1.04|2.9|||Regression, Logistic|||||2.90|1.04|0.034
74006976|NCT04427501|147563447|SUPERIORITY||Odds Ratio (OR)|1.15||||0.594|TWO_SIDED|95.0|0.69|1.91|||Regression, Logistic|||||1.91|0.69|0.594
74006977|NCT04427501|147563447|SUPERIORITY||Odds Ratio (OR)|1.32||||0.291|TWO_SIDED|95.0|0.79|2.2|||Regression, Logistic|||||2.20|0.79|0.291
74006978|NCT04427501|147563447|SUPERIORITY||Odds Ratio (OR)|1.45||||0.143|TWO_SIDED|95.0|0.88|2.4|||Regression, Logistic|||||2.40|0.88|0.143
74006979|NCT04427501|147563448|SUPERIORITY||Odds Ratio (OR)|1.89||||0.014|TWO_SIDED|95.0|1.14|3.15|||Regression, Logistic|||||3.15|1.14|0.014
74006980|NCT04427501|147563448|SUPERIORITY||Odds Ratio (OR)|1.06||||0.828|TWO_SIDED|95.0|0.64|1.74|||Regression, Logistic|||||1.74|0.64|0.828
74006981|NCT04427501|147563448|SUPERIORITY||Odds Ratio (OR)|1.82||||0.022|TWO_SIDED|95.0|1.09|3.02|||Regression, Logistic|||||3.02|1.09|0.022
74006982|NCT04427501|147563448|SUPERIORITY||Odds Ratio (OR)|1.48||||0.119|TWO_SIDED|95.0|0.9|2.43|||Regression, Logistic|||||2.43|0.90|0.119
74006983|NCT04427501|147563451|SUPERIORITY||Odds Ratio (OR)|0.23||||0.098|TWO_SIDED|95.0|0.04|1.31|||Regression, Logistic|||||1.31|0.04|0.098
74006984|NCT04427501|147563451|SUPERIORITY||Odds Ratio (OR)|0.37||||0.165|TWO_SIDED|95.0|0.09|1.51|||Regression, Logistic|||||1.51|0.09|0.165
74006985|NCT04427501|147563451|SUPERIORITY||Odds Ratio (OR)|0.39||||0.191|TWO_SIDED|95.0|0.1|1.6|||Regression, Logistic|||||1.60|0.10|0.191
74006986|NCT04427501|147563451|SUPERIORITY||Odds Ratio (OR)|0.21||||0.075|TWO_SIDED|95.0|0.04|1.18|||Regression, Logistic|||||1.18|0.04|0.075
74006987|NCT04427501|147563452|SUPERIORITY|||||||0.616|||||||Stratified Log-rank|||||||0.616
74006988|NCT04427501|147563452|SUPERIORITY|||||||0.281|||||||Stratified Log-rank|||||||0.281
74006989|NCT04427501|147563452|SUPERIORITY|||||||0.815|||||||Stratified Log-rank|||||||0.815
74006990|NCT04427501|147563452|SUPERIORITY|||||||0.334|||||||Stratified Log-rank|||||||0.334
74006991|NCT03739437|147563487|SUPERIORITY|||||||0.384|||||||Chi-squared|||||||0.384
74006992|NCT01554488|147563553|OTHER||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-5.03|2.92||||||All of the comparisons were based on mixed effects linear regression models with visit and group\*visit as fixed effects and subject as a random effect. Confidence intervals for the treatment difference (group\*visit interaction) were constructed using the Wald method.||2.92|-5.03|
74006993|NCT02383589|147563571|SUPERIORITY||Difference in proportion|30.8|||<|0.0001|TWO_SIDED|95.0|14.7|45.15||The analysis was stratified by the stratification factors applied at randomization.|Cochran-Mantel-Haenszel|||||45.15|14.70|<0.0001
74006994|NCT02383589|147563572|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
74006995|NCT02383589|147563573|SUPERIORITY||Adjusted Rate Ratio|0.12|||<|0.0001|TWO_SIDED|95.0|0.05|0.29||The model was adjusted for the following covariates in addition to log (each participant's duration in study) as an offset: treatment, region, duration of illness, baseline PDAI activity score, and baseline prednisone dose.|Negative Binominal Regression|||||0.29|0.05|<0.0001
74006996|NCT02383589|147563574|SUPERIORITY||Hazard Ratio (HR)|4.83||||0.0003|TWO_SIDED|95.0|1.97|11.81||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank|||||11.81|1.97|0.0003
74006997|NCT02383589|147563575|SUPERIORITY||Hazard Ratio (HR)|0.15|||<|0.0001|TWO_SIDED|95.0|0.06|0.39||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank|||||0.39|0.06|<0.0001
74006998|NCT02383589|147563576|SUPERIORITY||Difference in Estimated Means|-2.872||||0.0012|TWO_SIDED|95.0|-4.577|-1.167||P-value is from Mixed Model Repeated Measures (MMRM) with unstructured covariance matrix, adjusting for treatment, region, duration of illness, baseline DLQI score, visit, and an interaction terms for visit × baseline DLQI score and visit × treatment|Mixed Model Repeated Measures|||||-1.167|-4.577|0.0012
74006999|NCT04124614|147563623|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-5.59||||0.0007|TWO_SIDED|95.0|-8.79|-2.38|||MMRM|||||-2.38|-8.79|0.0007
74007000|NCT04124614|147563624|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-0.47||||0.0019|TWO_SIDED|95.0|-0.76|-0.17|||MMRM|||||-0.17|-0.76|0.0019
74007001|NCT04124614|147563625|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-12.03||||0.0016|TWO_SIDED|95.0|-19.44|-4.62|||MMRM|||||-4.62|-19.44|0.0016
74007002|NCT03219320|147563657|OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
74091285|NCT00688376|147736497|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.4||||0.743|TWO_SIDED|95.0|-9.56|6.85|||ANCOVA|||RTVSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||6.85|-9.56|0.743
74091286|NCT00688376|147736497|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.9561|TWO_SIDED|95.0|-7.42|7.84|||ANCOVA|||RTVSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||7.84|-7.42|0.9561
74091287|NCT00688376|147736497|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.5||||0.4385|TWO_SIDED|95.0|-3.97|9.04|||ANCOVA|||RTSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||9.04|-3.97|0.4385
73878567|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|8.0|42.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4||42.9|8.0|<0.001
74007003|NCT00726622|147563660|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Assuming a baseline rate of 90% oncologic success for the open resection arm, the sample size provided 80% power to declare non-inferiority if oncologic success rates were truly identical, using a 1-sided z score with α = .10 for falsely declaring non-inferiority when the true oncologic success rate for laparoscopic resection was 84%. Calculations were based on a 2-sample binomial non-inferiority calculation with a 90% success rate for the control group and a 6% non-inferiority margin.||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
73957394|NCT01651949|147450897|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.4|1.0|||Miettinen & Nurminen|||Anti-HPV Type 45||1.0|-0.4|<0.001
74007004|NCT03872453|147563676|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|4.2||||0.1214|TWO_SIDED|98.3|-2.3|10.7||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||10.7|-2.3|0.1214
74007005|NCT03872453|147563676|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.0||||0.0113|TWO_SIDED|98.3|0.4|13.7||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||13.7|0.4|0.0113
74038887|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.78|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|4.05|15.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||15.51|4.05|<0.001
74038888|NCT01763866|147630773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.06|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|4.4|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||13.72|4.40|<0.001
74038889|NCT01669811|147630782|SUPERIORITY_OR_OTHER||Difference in proportions|23.8|||<|0.0001|TWO_SIDED|95.0|14.9|32.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd||32.6|14.9|<0.0001
74038890|NCT01669811|147630783|SUPERIORITY_OR_OTHER||Difference in proportions|32.8|||<|0.0001|TWO_SIDED|95.0|21.9|42.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd||42.6|21.9|<0.0001
73957395|NCT01651949|147450897|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 52||0.9|-0.2|<0.001
74038891|NCT01669811|147630784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.1452|TWO_SIDED|95.0|0.91|1.83|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||1.83|0.91|0.1452
74091288|NCT00688376|147736497|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4||||0.9088|TWO_SIDED|95.0|-6.74|6.0|||ANCOVA|||RTSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||6|-6.74|0.9088
74091289|NCT00688376|147736498|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.7||||0.2886|TWO_SIDED|95.0|-1.5|4.96|||ANCOVA|||Global Executive Composite Score Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.96|-1.5|0.2886
73878568|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|58.6|||<|0.001|TWO_SIDED|95.0|37.2|75.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4||75.9|37.2|<0.001
74091290|NCT00688376|147736498|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.1||||0.2555|TWO_SIDED|95.0|-1.54|5.69|||ANCOVA|||Behavioral Regulation Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||5.69|-1.54|0.2555
73878569|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.4||||0.024|TWO_SIDED|95.0|-1.7|34.2||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1||34.2|-1.7|0.024
74007006|NCT03872453|147563676|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.7||||0.0055|TWO_SIDED|98.3|1.1|14.3||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||14.3|1.1|0.0055
74007007|NCT03872453|147563677|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|5.4||||0.1162|TWO_SIDED|98.3|-2.8|13.6||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||13.6|-2.8|0.1162
74007008|NCT03872453|147563677|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|8.3||||0.0155|TWO_SIDED|98.3|0.1|16.5||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||16.5|0.1|0.0155
74007009|NCT03872453|147563677|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|8.9||||0.0094|TWO_SIDED|98.3|0.7|17.0||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||17.0|0.7|0.0094
74008943|NCT01286454|147568262|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|134.83|||||TWO_SIDED|90.0|120.31|151.09||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||151.09|120.31|
73878570|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.7||||0.34|TWO_SIDED|95.0|-12.0|35.5||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1||35.5|-12.0|0.34
74007010|NCT03872453|147563678|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.1||||0.0439|TWO_SIDED|98.3|-1.3|15.4||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||If the coprimary endpoint tests were both significant for a zavegepant dose group versus placebo, the secondary endpoints were tested for that zavegepant dose group versus placebo using a hierarchical gate-keeping procedure in the order the endpoints are reported, with each test in the hierarchy conducted at alpha = 0.0167. If a test in the hierarchy was not significant, any further tests on endpoints in the sequence were not considered significant for any zavegepant dose group versus placebo.||15.4|-1.3|0.0439
74007011|NCT03872453|147563678|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.5||||0.0302|TWO_SIDED|98.3|-0.8|15.9||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||If the coprimary endpoint tests were both significant for a zavegepant dose group versus placebo, the secondary endpoints were tested for that zavegepant dose group versus placebo using a hierarchical gate-keeping procedure in the order the endpoints are reported, with each test in the hierarchy conducted at alpha = 0.0167. If a test in the hierarchy was not significant, any further tests on endpoints in the sequence were not considered significant for any zavegepant dose group versus placebo.||15.9|-0.8|0.0302
74007012|NCT00863109|147563709|SUPERIORITY_OR_OTHER|||||||0.027|||||||Student´s t-test for paired samples|||Within-group comparison of Worry domain between BL Visit and WK72 Visit||||0.027
74007013|NCT00863109|147563710|SUPERIORITY_OR_OTHER|||||||0.038|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in MCS||||0.038
74007014|NCT00863109|147563711|SUPERIORITY_OR_OTHER|||||||0.014|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Emotional Function domain||||0.014
74007015|NCT00863109|147563711|SUPERIORITY_OR_OTHER|||||||0.009|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Worry domain||||0.009
74007016|NCT00863109|147563711|SUPERIORITY_OR_OTHER|||||||0.022|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in CLDQ-HCV Global domain||||0.022
74007017|NCT00440700|147563736|SUPERIORITY_OR_OTHER||Slope|15.5|||<|0.05||95.0|||||Mixed Models Analysis|||Mixed models analysis was used to determine if there were any differences in anxiety levels in patients who listen to music as compared to headphones only or usual ICU care.||||<0.05
74007018|NCT00440700|147563738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.61|<|0.05|ONE_SIDED|95.0|||||Kruskal-Wallis||Usual care was the reference comparison group.|Length of mechanical ventilatory support was assessed among all 3 groups. Usual usual care was the reference group as compared to the experimental patient-directed music group.||||<0.05
74007019|NCT00440700|147563739|SUPERIORITY_OR_OTHER||Slope|5.0|||<|0.05||95.0|||||Mixed Models Analysis|||Cortisol levels were compared among all 3 groups.||||<0.05
74007020|NCT03739762|147563755|SUPERIORITY||Mean Difference (Final Values)|-31.85||||0.003|TWO_SIDED|95.0|-52.91|-10.79|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||The sample size of 284 ensured 90% power to detect a 41-minute difference in sitting time between I-STAND and the attention control from baseline to 6 months, assuming a standard deviation (SD) of 97 minutes/day for change in sitting time (based on our pilot data), and 15% loss to follow-up. Sample and power calculations were performed using R software version 3.5 \[39\] via simulation, assuming specified SDs and differences between means.||-10.79|-52.91|0.003
74007021|NCT03739762|147563756|SUPERIORITY||Mean Difference (Final Values)|-3.48||||0.033|TWO_SIDED|95.0|-6.68|-0.28|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||-0.28|-6.68|.033
74038892|NCT01669811|147630785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.0837|TWO_SIDED|95.0|0.97|2.18|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.18|0.97|0.0837
74038893|NCT01669811|147630786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.2678|TWO_SIDED|95.0|0.8|2.26|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.26|0.80|0.2678
74038894|NCT01669811|147630787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6389|TWO_SIDED|95.0|0.62|2.12|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.12|0.62|0.6389
74038895|NCT01669811|147630788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.38||||0.4485|TWO_SIDED|95.0|0.8|2.38|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.38|0.80|0.4485
74091291|NCT00688376|147736498|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.7||||0.3155|TWO_SIDED|95.0|-1.63|4.99|||ANCOVA|||Metacognition Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.99|-1.63|0.3155
74007022|NCT03739762|147563757|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.784|TWO_SIDED|95.0|-1.63|2.16|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||2.16|-1.63|.784
74007023|NCT03739762|147563758|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.927|TWO_SIDED|95.0|-2.61|2.38|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||2.38|-2.61|.927
74007024|NCT03739762|147563759|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.916|TWO_SIDED|95.0|-0.42|0.47|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||0.47|-0.42|.916
74007025|NCT03739762|147563760|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.325|TWO_SIDED|95.0|-1.09|0.36|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||0.36|-1.09|.325
74091292|NCT00688376|147736498|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2||||0.9075|TWO_SIDED|95.0|-3.55|3.16|||ANCOVA|||Working Memory Scale Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||3.16|-3.55|0.9075
74038896|NCT04390568|147630789|OTHER|The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and the area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of the intravenous dose groups.|Slope|1.123|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|90.0|0.979|1.268|||||Based on the estimate for slope parameter (β), a 2-sided 90% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|No statistical hypotheses tests were planned for this trial.||1.268|0.979|
74038897|NCT04390568|147630790|OTHER|The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and the maximum measured concentration of the Spesolimap in plasma (Cmax) of the intravenous dose groups.|Slope|1.072|STANDARD_ERROR_OF_MEAN|0.065|||TWO_SIDED|90.0|0.961|1.183|||||Based on the estimate for slope parameter (β), a 2-sided 90% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|No statistical hypotheses tests were planned for this trial.||1.183|0.961|
74038898|NCT03245723|147630793|OTHER|Descriptive statistics||||||0.38|||||||Wilcoxon Rank Sum test|||||||0.38
74038899|NCT03245723|147630794|OTHER|Descriptive statistics||||||0.12|||||||Wilcoxon Rank Sum test|||||||0.12
74038900|NCT04656418|147630876|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical Testing H01) at alpha = 5%.|Two-sided Wilcoxon test|||||||<0.001
74038901|NCT04656418|147630877|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
74038902|NCT04656418|147630878|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
74038903|NCT04656418|147630878|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
74038904|NCT04656418|147630878|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
74038905|NCT04656418|147630879|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
74038906|NCT04656418|147630879|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
74038907|NCT04656418|147630879|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
74038908|NCT04656418|147630880|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
74038909|NCT04656418|147630880|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
73957396|NCT01651949|147450897|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 58||0.9|-0.2|<0.001
74038910|NCT04656418|147630881|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical testing H02) at alpha = 5%.|Two-sided Wilcoxon test|||||||<0.001
74038911|NCT03097614|147630899|SUPERIORITY|||||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
74038912|NCT00225147|147630965|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
74038913|NCT00225147|147630965|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
74038914|NCT00225147|147630966|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Log Rank|||||||0.040
74038915|NCT00225147|147630966|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
74038916|NCT02513771|147631018|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank-sum test stratified by screening CD4 count (\<= or \> 350 cells/mm\^3) and statin use.||Null hypothesis: There is no difference between the two arms in the change in sCD14 from baseline to week 15/16.||||1.000
74038917|NCT01797445|147631034|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|3.1||||0.13|TWO_SIDED|95.002|-1.0|7.1|||Cochran-Mantel-Haenszel|P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL) and region (US vs ex-US).|The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was \< 12% worse than the E/C/F/TDF group.||7.1|-1.0|0.13
74038918|NCT01595438|147631051|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Difference of symp resolution rates|4.0|||||TWO_SIDED|95.0|-2.39|10.42|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin||10.42|-2.39|
74038919|NCT01595438|147631052|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable combined resp rates|6.7|||||TWO_SIDED|95.0|0.3|13.12|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin||13.12|0.30|
74091293|NCT02623348|147736516|SUPERIORITY||||||<|0.01||||||Threshold for significance: \<0.05|linear mixed modeling|||||||<0.01
74007026|NCT02464228|147563767|OTHER|||||||0|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||0.000
74007027|NCT02464228|147563767|OTHER|||||||1|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||1.000
74007028|NCT02464228|147563767|OTHER|||||||0.026|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||0.026
74007029|NCT02464228|147563767|OTHER|||||||1|||||||Clopper-Pearson method|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||1.000
74007030|NCT02294682|147563836|SUPERIORITY_OR_OTHER||Microbio Response Urogenital Gonorrhea|97.0|||||ONE_SIDED|95.0|85.1||||||GSK2140944 1500 mg||||85.1|
74007031|NCT02294682|147563836|SUPERIORITY_OR_OTHER||Microbio Response Urogenital Gonorrhea|95.0|||||ONE_SIDED|95.0|84.7||||||GSK2140944 3000 mg||||84.7|
74038920|NCT01595438|147631053|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable response rates|6.4|||||TWO_SIDED|95.0|0.33|12.36|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin||12.36|0.33|
74038921|NCT01595438|147631054|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.4|||||TWO_SIDED|95.0|-2.7|3.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||3.56|-2.70|
74007032|NCT02022085|147563894|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 6 months with Baha Attract vs Unaided||||<0.0001
74007033|NCT02022085|147563894|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 12 months with Baha Attract vs Unaided||||<0.0001
74007034|NCT02022085|147563894|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 24 months with Baha Attract vs Unaided||||<0.0001
74038922|NCT01595438|147631055|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.68|13.81|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.81|0.68|
74091294|NCT02701413|147736528|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
74007035|NCT02022085|147563895|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 24 months vs Unaided situation Pre-Op||||<0.0001
74007036|NCT02022085|147563896|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 12 months vs Unaided situation Pre-Op||||<0.0001
74007037|NCT02022085|147563897|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 6 months vs Unaided situation Pre-Op||||<0.0001
74007038|NCT02022085|147563898|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in Noise, 6 months Baha Attract vs Unaided||||<0.0001
74007039|NCT02022085|147563898|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in Noise, 12 months Baha Attract vs Unaided||||<0.0001
74007040|NCT02022085|147563898|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in Noise, 24 months Baha Attract vs Unaided||||<0.0001
74007041|NCT02022085|147563899|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 50dB||||<0.0001
74007042|NCT02022085|147563899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 65dB||||<0.0001
74007043|NCT02022085|147563899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 80dB||||<0.0001
74007044|NCT02022085|147563899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 50dB||||<0.0001
74007045|NCT02022085|147563899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 65dB||||<0.0001
74007046|NCT02022085|147563899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 80dB||||<0.0001
74007047|NCT02022085|147563899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 50dB||||<0.0001
74007048|NCT02022085|147563899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 65dB||||<0.0001
74007049|NCT02022085|147563899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 80dB||||<0.0001
74007050|NCT02022085|147563900|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months with Baha Attract vs Softband: change in PTA4||||0.38
74007051|NCT02022085|147563900|SUPERIORITY_OR_OTHER|||||||0.84|||||||Fisher's non-parametric permutation test|||12 months with Baha Attract vs Softband: change in PTA4||||0.84
74038923|NCT01595438|147631056|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.21|1.72|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.72|-1.21|
74091295|NCT02701413|147736532|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
74091296|NCT00472797|147736533|SUPERIORITY_OR_OTHER||mean|2.73|||<|0.001||97.5|2.73|2.73||P-Value denotes percent change from baseline to week 12 for all combined subjects.|t-test, 1 sided|||A one-sided paired t-test across all subjects by combining the titrated and non-titrated new formulation groups was performed.||2.73|2.73|<0.001
74091297|NCT00472797|147736534|SUPERIORITY_OR_OTHER|||||||0.466||||||P-value denotes difference between treatment groups|ANOVA|||||||0.466
74091298|NCT00472797|147736534|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided|||||||<0.001
74007052|NCT02022085|147563900|SUPERIORITY_OR_OTHER|||||||0.89|||||||Fisher's non-parametric permutation test|||24 months with Baha Attract vs Softband: change in PTA4||||0.89
74007053|NCT02022085|147563901|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||250Hz: 6 months with Baha Attract vs Softband||||0.34
74007054|NCT02022085|147563901|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||500Hz: 6 months with Baha Attract vs Softband||||0.0004
74007055|NCT02022085|147563901|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||1000Hz: 6 months with Baha Attract vs Softband||||0.22
74007056|NCT02022085|147563901|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||2000Hz: 6 months with Baha Attract vs Softband||||0.64
74007057|NCT02022085|147563901|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||3000Hz: 6 months with Baha Attract vs Softband||||0.039
74007058|NCT02022085|147563901|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||4000Hz: 6 months with Baha Attract vs Softband||||0.012
74007059|NCT02022085|147563901|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6000Hz: 6 months with Baha Attract vs Softband||||<0.0001
74007060|NCT02022085|147563902|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher's non-parametric permutation test|||250Hz: 12 months with Baha Attract vs Softband||||0.11
74007061|NCT02022085|147563902|SUPERIORITY_OR_OTHER|||||||0.066|||||||Fisher's non-parametric permutation test|||500Hz: 12 months with Baha Attract vs Softband||||0.066
74007062|NCT02022085|147563902|SUPERIORITY_OR_OTHER|||||||0.71|||||||Fisher's non-parametric permutation test|||1000Hz: 12 months with Baha Attract vs Softband||||0.71
74007063|NCT02022085|147563902|SUPERIORITY_OR_OTHER|||||||0.78|||||||Fisher's non-parametric permutation test|||2000Hz: 12 months with Baha Attract vs Softband||||0.78
74007064|NCT02022085|147563902|SUPERIORITY_OR_OTHER|||||||0.015|||||||Fisher's non-parametric permutation test|||3000Hz: 12 months with Baha Attract vs Softband||||0.015
74007065|NCT02022085|147563902|SUPERIORITY_OR_OTHER|||||||0.035|||||||Fisher's non-parametric permutation test|||4000Hz: 12 months with Baha Attract vs Softband||||0.035
74007066|NCT02022085|147563902|SUPERIORITY_OR_OTHER|||||||0.0013|||||||Fisher's non-parametric permutation test|||6000Hz: 12 months with Baha Attract vs Softband||||0.0013
74007067|NCT02022085|147563903|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Fisher's non-parametric permutation test|||250Hz: 24 months with Baha Attract vs Softband||||0.0051
74007068|NCT02022085|147563903|SUPERIORITY_OR_OTHER|||||||0.26|||||||Fisher's non-parametric permutation test|||500Hz: 24 months with Baha Attract vs Softband||||0.26
74007069|NCT02022085|147563903|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher's non-parametric permutation test|||1000Hz: 24 months with Baha Attract vs Softband||||0.22
74007070|NCT02022085|147563903|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher's non-parametric permutation test|||2000Hz: 24 months with Baha Attract vs Softband||||0.57
74007071|NCT02022085|147563903|SUPERIORITY_OR_OTHER|||||||0.064|||||||Fisher's non-parametric permutation test|||3000Hz: 24 months with Baha Attract vs Softband||||0.064
74007072|NCT02022085|147563903|SUPERIORITY_OR_OTHER|||||||0.064|||||||Fisher's non-parametric permutation test|||4000Hz: 24 months with Baha Attract vs Softband||||0.064
74007073|NCT02022085|147563903|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Fisher's non-parametric permutation test|||6000Hz: 24 months with Baha Attract vs Softband||||0.0051
74007074|NCT02022085|147563904|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Speech in Noise with Baha Attract vs Softband||||0.46
74007075|NCT02022085|147563904|SUPERIORITY_OR_OTHER|||||||0.19|||||||Fisher's non-parametric permutation test|||12 months: Speech in Noise with Baha Attract vs Softband||||0.19
74007076|NCT02022085|147563904|SUPERIORITY_OR_OTHER|||||||0.31|||||||Fisher's non-parametric permutation test|||24 months: Speech in Noise with Baha Attract vs Softband||||0.31
74007077|NCT02022085|147563905|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 50dB||||0.43
74007078|NCT02022085|147563905|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 65dB||||0.16
74007079|NCT02022085|147563905|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 80dB||||0.65
74007080|NCT02022085|147563905|SUPERIORITY_OR_OTHER|||||||0.93|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 50dB||||0.93
74007081|NCT02022085|147563905|SUPERIORITY_OR_OTHER|||||||0.094|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 65dB||||0.094
74007082|NCT02022085|147563905|SUPERIORITY_OR_OTHER|||||||0.44|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 80dB||||0.44
74007083|NCT02022085|147563905|SUPERIORITY_OR_OTHER|||||||0.021|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 50dB||||0.021
74007084|NCT02022085|147563905|SUPERIORITY_OR_OTHER|||||||0.024|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 65dB||||0.024
74007085|NCT02022085|147563905|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 80dB||||0.59
74007086|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Comprehensive health state||||0.088
74007087|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Vision||||0.88
74007088|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Hearing||||0.020
74007089|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Speech||||0.039
74007090|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Ambulation||||0.25
74007091|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Dexterity||||0.38
74007092|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Emotion||||0.43
74007093|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Cognition||||0.85
74007094|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Pain||||0.25
74007095|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||24 months change in Comprehensive health state||||0.088
74007096|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.63|||||||Fisher's non-parametric permutation test|||24 months change in Vision||||0.63
74007097|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||24 months change in Hearing||||0.045
74007098|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.016|||||||Fisher's non-parametric permutation test|||24 months change in Speech||||0.016
74007099|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher's non-parametric permutation test|||24 months change in Ambulation||||0.25
74091299|NCT00472797|147736534|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided|||||||0.003
74007100|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxan Signed Rank Test|Fisher's non-parametric permutation test failed to approximate p value so Wilcoxan Signed Rank Test instead||24 months change in Dexterity||||0.50
74007101|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher's non-parametric permutation test|||24 months change in Emotion||||0.29
74007102|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.92|||||||Fisher's non-parametric permutation test|||24 months change in Cognition||||0.92
74007103|NCT02022085|147563906|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher's non-parametric permutation test|||24 months change in Pain||||0.020
74007104|NCT02022085|147563907|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Ease of communication||||<0.0001
74007105|NCT02022085|147563907|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Background noise||||<0.0001
74007106|NCT02022085|147563907|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Reverberation||||<0.0001
74007107|NCT02022085|147563907|SUPERIORITY_OR_OTHER|||||||0.69|||||||Fisher's non-parametric permutation test|||6 months: Aversiveness||||0.69
74007108|NCT02022085|147563907|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Global||||<0.0001
74007109|NCT02022085|147563907|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Ease of communication||||<0.001
74007110|NCT02022085|147563907|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Background noise||||<0.001
74007111|NCT02022085|147563907|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Reverberation||||<0.001
74007112|NCT02022085|147563907|SUPERIORITY_OR_OTHER|||||||0.84|||||||Fisher's non-parametric permutation test|||24 months: Aversiveness||||0.84
74007113|NCT02022085|147563907|SUPERIORITY_OR_OTHER||Fisher's non-parametric permutation test||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Global||||<0.001
74007114|NCT02022085|147563908|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech: Change from pre-op to 6 months||||<0.0001
74007115|NCT02022085|147563908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Spatial: Change from pre-op to 6 months||||<0.0001
74007116|NCT02022085|147563908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Qualities: Change from pre-op to 6 months||||<0.0001
74007117|NCT02022085|147563908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech: Change from pre-op to 24 months||||<0.0001
74007118|NCT02022085|147563908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Spatial: Change from pre-op to 24 months||||<0.0001
74007119|NCT02022085|147563908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Qualities: Change from pre-op to 24 months||||<0.0001
74007120|NCT01179672|147563925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.03|TWO_SIDED|95.0|-0.82|-0.04|||Mixed Models Analysis|||||-0.04|-0.82|0.030
74007121|NCT01179672|147563926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.008|TWO_SIDED|95.0|-0.95|-0.14||P-value is for mean change from baseline to 12-week endpoint in night pain.|Mixed Models Analysis|||||-0.14|-0.95|0.008
74007122|NCT01179672|147563926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.017|TWO_SIDED|95.0|-1.0|-0.1||P-value is for mean change from baseline to 12 week endpoint in worst pain.|Mixed Models Analysis|||||-0.10|-1.00|0.017
74007123|NCT01179672|147563927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.016|TWO_SIDED|95.0|-0.9|-0.09|||Mixed Models Analysis|||||-0.09|-0.90|0.016
74007124|NCT01179672|147563928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.081|TWO_SIDED|95.0|-0.48|0.03|||Mixed Models Analysis|||||0.03|-0.48|0.081
74007125|NCT01179672|147563929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.034|TWO_SIDED|95.0|-0.4|-0.02|||Mixed Models Analysis|||||-0.02|-0.40|0.034
74007126|NCT01179672|147563930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.022|TWO_SIDED|95.0|-2.07|-0.16|||ANCOVA|ANCOVA adjusted for treatment, pooled investigator and baseline.||||-0.16|-2.07|0.022
74007127|NCT01179672|147563931|SUPERIORITY_OR_OTHER|||||||0.014||||||P-value is for ≥30% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.014
74007128|NCT01179672|147563931|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for ≥50% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.006
74007129|NCT01179672|147563931|SUPERIORITY_OR_OTHER|||||||0.193||||||P-value is for ≥75% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.193
74091300|NCT00472797|147736535|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value refers to change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ for all subjects combined.|t-test, 1 sided|Paired t-test for change from baseline to week 12||Change in total score from baseline to week 12 for all subjects combined. Lower scores indicate a more favorable response||||<0.001
74007130|NCT01179672|147563932|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value is for ≥30% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.003
74038924|NCT01595438|147631057|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.8|||||TWO_SIDED|95.0|2.27|15.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||15.24|2.27|
74038925|NCT01595438|147631058|SUPERIORITY_OR_OTHER||Diff of favorable response rates|10.9|||||TWO_SIDED|95.0|2.86|18.85|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||18.85|2.86|
74038926|NCT01595438|147631059|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.17|1.68|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.68|-1.17|
74038927|NCT01595438|147631060|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.88|13.74|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.74|0.88|
73957397|NCT01806714|147450900|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||<|0.04|TWO_SIDED|95.0|1.0|1.6|||clustered stratified Proportional Hazard||We determined hazard ratios using a clustered stratified Cox model with the Efron method to handle tied events and the Huber/White variance estimator that clustered on primary care provider and stratified on practice.|||1.6|1.0|<0.04
73957398|NCT02469064|147450903|OTHER||Hazard Ratio (HR)|0.82||||0.84|TWO_SIDED|95.0|0.55|1.2|||Mann Whitneey||Univariate analysis of the probability of extubation was performed using Kaplan-Meir survival analysis and the logrank test.The multivariate analysis was performed by cox regression, a simple model was performed and a final model.|||1.20|0.55|0.84
73957399|NCT02469064|147450904|OTHER||Slope|0.46||||0.48|TWO_SIDED|95.0|-3.75|4.78|||t-test, 2 sided||The slope shows the difference between the means of the change in the MIP of the group that received the experimental treatment and the group that received the conventional treatment|||4.78|-3.75|0.48
73957400|NCT02155829|147450905|SUPERIORITY|||||||0.442|||||||ANCOVA|ANCOVA covariate included site.||||||0.442
73957401|NCT02155829|147450906|SUPERIORITY|||||||0.994|||||||ANCOVA|ANCOVA covariate included site.||||||0.994
74007131|NCT01179672|147563932|SUPERIORITY_OR_OTHER|||||||0.001||||||P-value is for ≥50% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.001
74007132|NCT01179672|147563932|SUPERIORITY_OR_OTHER|||||||0.168||||||P-value is for ≥75% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel test was stratified by pooled investigator.||||||0.168
74007133|NCT01179672|147563933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.001|TWO_SIDED|95.0|-0.96|-0.24|||Mixed Models Analysis|||||-0.24|-0.96|0.001
74007134|NCT01179672|147563934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.02|TWO_SIDED|95.0|-2.33|-0.2|||Mixed Models Analysis|||||-0.20|-2.33|0.020
74007135|NCT01187550|147563936|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||Wilcoxon rank sum test|||||||0.194
74007136|NCT01187550|147563937|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||Wilcoxon rank sum test|||||||0.752
74007137|NCT01187550|147563938|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon rank sum test|||||||0.710
74007138|NCT01187550|147563939|SUPERIORITY_OR_OTHER|||||||0.265||95.0|||||Wilcoxon rank sum test|||||||0.265
74007139|NCT01187550|147563940|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Wilcoxon rank sum test|||||||0.308
74007140|NCT01187550|147563941|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||Wilcoxon rank sum test|||For total cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.078
74007141|NCT01187550|147563941|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Wilcoxon rank sum test|||For HDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.033
74007142|NCT01187550|147563941|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon rank sum test|||For LDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.041
74007143|NCT01187550|147563941|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||Wilcoxon rank sum test|||For triglycerides: Wilcoxon rank sum test was used to calculate p-value.||||0.091
74007144|NCT00129623|147563942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.1226|||<|0.0001|TWO_SIDED|95.0|2.9613|5.2838||The primary analysis was an ANOVA (two way classification), including treatment group and time since menopause (as a binary variable; 0.5-3 years, \>3 years) as independent factors.|ANOVA|||"H0 (null hypothesis): There was no statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD).~H1 (alternative hypothesis): There was a statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD)."||5.2838|2.9613|<0.0001
74007145|NCT00129623|147563948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.51|||||TWO_SIDED|95.0|5.12|30.56||||||Lumbar BMD: Adjusted treatment effect - The treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||30.56|5.12|
74007146|NCT00129623|147563948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.59|||||TWO_SIDED|95.0|3.8|19.42||||||Proximal femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg once monthly/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||19.42|3.80|
73878571|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|51.4|||<|0.001|TWO_SIDED|95.0|34.3|66.3||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA||66.3|34.3|<0.001
73957402|NCT02155829|147450907|SUPERIORITY|||||||0.684|||||||ANCOVA|ANCOVA covariate included site.||||||0.684
74007147|NCT00129623|147563948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.8|||||TWO_SIDED|95.0|5.17|36.79||||||Lumbar Spine and Proximal Femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable, and treatment group (oral IBN150 mg/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||36.79|5.17|
74007148|NCT02616614|147563951|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval \[0.80,1.25\] for the PP population.|Mean Difference (Net)|0.95|||||TWO_SIDED|90.0|0.88|1.03||||||||1.03|0.88|
74007149|NCT02616614|147563951|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
74007150|NCT02616614|147563951|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
74007151|NCT02616614|147563952|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval \[0.80, 1.25\] for the PP population.|Mean Difference (Net)|1.0|||||TWO_SIDED|90.0|0.9|1.11||||||||1.11|0.90|
73878572|NCT00880698|147296738|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|65.1|||<|0.001|TWO_SIDED|95.0|42.7|81.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA||81.7|42.7|<0.001
73957403|NCT02155829|147450908|SUPERIORITY|||||||0.913|||||||ANCOVA|ANCOVA covariate included site.||||||0.913
73957404|NCT02155829|147450909|SUPERIORITY|||||||0.746|||||||ANCOVA|ANCOVA covariate included site.||||||0.746
73957405|NCT02155829|147450910|SUPERIORITY|||||||0.057|||||||ANCOVA|ANCOVA covariate included site.||||||0.057
73957406|NCT02155829|147450911|SUPERIORITY|||||||0.0496|||||||ANCOVA|ANCOVA covariate included site.||||||0.0496
73957407|NCT01585038|147450913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.3|TWO_SIDED|95.0|-1.56|2.64|||t-test, 1 sided|||||2.64|-1.56|0.30
73957408|NCT01585038|147450914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.21||||0.35|TWO_SIDED|95.0|-4.71|2.3|||t-test, 2 sided|||||2.30|-4.71|0.35
73957409|NCT01585038|147450915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7||||0.41|TWO_SIDED|95.0|-62.49|75.89|||t-test, 2 sided|||||75.89|-62.49|0.41
73957410|NCT01585038|147450916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-194.1||||0.02|TWO_SIDED|95.0|-353.7|-34.6|||t-test, 2 sided|||||-34.6|-353.7|0.02
73957411|NCT00678795|147450917|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.569|TWO_SIDED|95.0|-0.47|0.26|||ANCOVA|||The primary endpoint, the change in the number of incontinence episodes per day, was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline number of incontinence episodes per day as a covariate.||0.26|-0.47|0.569
73957412|NCT00678795|147450918|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.76||||0.071|TWO_SIDED|95.0|-1.58|0.07|||ANCOVA|||The change in the number of urgency episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of urgency episodes per day as a covariate.||0.07|-1.58|0.071
73957413|NCT00678795|147450919|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.28||||0.01|TWO_SIDED|95.0|-0.5|-0.07|||ANCOVA|||The change in the number of nocturia episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of nocturia episodes per day as a covariate.||-0.07|-0.50|0.010
73957414|NCT00678795|147450920|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.74|TWO_SIDED|95.0|-0.57|0.41|||ANCOVA|||The change in the number of incontinence pads used per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of number of incontinence pads used per day as a covariate.||0.41|-0.57|0.74
73957415|NCT00678795|147450921|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.9||||0.166|TWO_SIDED|95.0|-1.65|9.46|||ANCOVA|||The change from baseline in the I-QOL score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline I-QOL score as a covariate.||9.46|-1.65|0.166
73957416|NCT00678795|147450922|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.16||||0.001|TWO_SIDED|95.0|-1.82|-0.51|||ANCOVA|||The change from baseline in the overall bladder condition Numerical Rating Scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline overall bladder condition Numerical Rating Scale score as a covariate.||-0.51|-1.82|0.001
73957417|NCT00678795|147450923|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|25.4||||0.002|TWO_SIDED|95.0|10.37|40.42|||Fisher Exact|||For Patient Global Impression of Change, the proportions of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' were compared between treatment groups using Fisher's Exact Test.||40.42|10.37|0.002
73957418|NCT00678795|147450924|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.85||||0.007|TWO_SIDED|95.0|-1.47|-0.23|||ANCOVA|||The change in the number of voids per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of voids per day as a covariate.||-0.23|-1.47|0.007
74007152|NCT02616614|147563952|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
74007153|NCT02616614|147563952|SUPERIORITY|||||||0.0006|||||||ANOVA|||||||0.0006
74007154|NCT02616614|147563953|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Mean Difference (Net)|-0.022|||||TWO_SIDED|90.0|-0.087|0.043|||||Equivalence was based on difference in the number of subjects with success. Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).||0.043|-0.087|
74007155|NCT03239483|147563967|SUPERIORITY|||||||0.072|||||||Fisher Exact|||two-sided Fisher's Exact Test||||0.072
74007156|NCT03239483|147563972|SUPERIORITY|||||||1||||||This is a calculated p-value. P-values of 1.0 are possible when using the Fisher Exact test method.|Fisher Exact|||||||1.00
74007157|NCT03239483|147563973|SUPERIORITY|||||||0.591|||||||Fisher Exact|||||||0.591
74007158|NCT01233869|147563987|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.86|||<|0.0001|TWO_SIDED|95.0|2.02|5.74|||Mixed Models Analysis|||Statistical Analysis 1 is comparison of annualized rate of kidney enlargement: placebo versus pooled bosutinib.||5.74|2.02|<0.0001
74007159|NCT01233869|147563987|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.83||||0.1234|TWO_SIDED|95.0|-0.5|4.22|||Mixed Models Analysis|||Statistical Analysis 2 is comparison of annualized rate of kidney enlargement: bosutinib 200 mg/day versus bosutinib 400/200 mg/day.||4.22|-0.50|0.1234
74007160|NCT01233869|147563987|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.06||||0.005|TWO_SIDED|95.0|0.93|5.23|||Mixed Models Analysis|||Statistical Analysis 3 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 200 mg/day.||5.23|0.93|0.0050
74007161|NCT01233869|147563987|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.41||||0.1336|TWO_SIDED|95.0|-1.03|8.05|||Mixed Models Analysis|||Statistical Analysis 4 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400 mg/day.||8.05|-1.03|0.1336
74007162|NCT01233869|147563987|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.95|||<|0.0001|TWO_SIDED|95.0|2.65|7.3|||Mixed Models Analysis|||Statistical Analysis 5 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400/200 mg/day.||7.30|2.65|<0.0001
74007163|NCT02967354|147564009|SUPERIORITY|||||||0.5875||||||Treshold for significance P\<0.05|ANOVA|||||||0.5875
74007164|NCT02967354|147564010|SUPERIORITY|||||||0.0065||||||Treshold for significance P\<0.05|ANOVA|||||||0.0065
74007165|NCT02967354|147564011|SUPERIORITY|||||||0.0072||||||Treshold for significance P\<0.05|ANOVA|||||||0.0072
74007166|NCT02967354|147564012|SUPERIORITY|||||||0.9472||||||Treshold for significance P\<0.05|ANOVA|||||||0.9472
74007167|NCT02967354|147564013|SUPERIORITY|||||||0.0048||||||Treshold for significance P\<0.05|ANOVA|||||||0.0048
74007168|NCT05696236|147564079|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.77
74007169|NCT05696236|147564080|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
74007170|NCT05696236|147564081|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
74007171|NCT05105789|147564103|SUPERIORITY|"One-sample binomial test. Null hypothesis: NPV of BinaxNOW at Home testing is at most 91%.~Alternative hypothesis: NPV of BinaxNOW at Home testing is greater than 91%."|Kappa Co-efficient|100.0||||0.0015|TWO_SIDED|95.0|95.0|100.0|||one-sample binomial test||binary outcome|Negative Predictive Value||100|95|0.0015
74007172|NCT05105789|147564103|NON_INFERIORITY|non-inferiority margin of δ=5% and a sensitivity/specificity of PCR of 99%||||||0.3308|||||||one-sample binomial test|||Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05||||0.3308
74007173|NCT05105789|147564103|NON_INFERIORITY|a non-inferiority margin of δ=5% and a sensitivity/specificity of PCR of 99%||||||0.0536|||||||one-sample binomial test|||Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05||||0.0536
74007174|NCT05105789|147564104|EQUIVALENCE|Concordance between the PCR test results will be evaluated by calculating the Kappa statistic which will be reported along with corresponding two-sided 95% confidence interval. The nonparametric bootstrap technique will be used to construct the confidence interval. A kappa statistic of \>0.95 will be considered as sufficient to define lollipop swab test non-inferior to the gold-standard PCR testing of nasal swabs.|Kappa Co-efficient|0.91|||||TWO_SIDED|95.0|0.78|1.0||||||Kappa statistics for Nasal Swab PCR vs Lollipop Swab PCR||1.00|0.78|
74007175|NCT05105789|147564105|NON_INFERIORITY|a non-inferiority margin of δ=5% and a sensitivity/specificity of PCR testing of 99%||||||0.201|||||||one-sample binomial test|||Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05||||0.2010
74007176|NCT05105789|147564105|NON_INFERIORITY|non-inferiority margin of δ=5% and a sensitivity/specificity of PCR testing of 99%||||||0.0705|||||||one-sample binomial test|||Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05||||0.0705
74007177|NCT00323297|147564112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|11.722||0.5802|TWO_SIDED|90.0|-21.843|17.087||A sequential closed-testing procedure was implemented for all secondary endpoints. If no statistically significant treatment effect was found for the primary endpoint then statistical tests were not to be performed on the secondary endpoints.|ANCOVA|The mean difference in method of estimation is the difference between Sildenafil - placebo.||"The estimated sample size was based upon the primary endpoint. A sample size of 51 subjects per treatment group was required to detect a difference of 30 meters between treatments with 80% power at a one-sided significance level of 0.05, assuming a standard deviation of 60 meters.~This primary statistical analysis was carried for Week 12 data."||17.087|-21.843|0.5802
73878573|NCT02649556|147296748|OTHER||LS Mean Difference|1.75|||||TWO_SIDED|95.0|-0.16|3.65||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of HDL-C levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|3.65|-0.160|
74007178|NCT03672461|147564165|SUPERIORITY||Model based LS mean difference|0.29||||0.056|TWO_SIDED|95.0|-0.01|0.6|||Mixed Models Analysis|adjusted for baseline value. Repeated measures mixed models, unstructured variance co-variance matrix||Null Hypothesis: Yoga is not associated with improvement in change from baseline in Total Urinary Incontinence Episodes||0.6|-0.01|0.056
74091301|NCT00472797|147736535|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value refers to differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ.|ANOVA|||Analysis evaluated differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ. Lower scores indicate a more favorable response.||||0.110
74091302|NCT00472797|147736536|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value refers to differneces in total score from baseline to week 12 between treatment groups.|ANOVA|||Analysis evaluates total score from baseline to week 12 for differences between each treatment group.||||0.302
73957419|NCT00404079|147450931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|STANDARD_DEVIATION|4.0||0.05|||||||Mixed Models Analysis|||Null hypothesis was glucosamine sulfate is not superior to placebo to reduce pain and disability associated with chronic low back pain. Power calculation was based on a 3 point difference between the groups with the primary outcome. Data was analysed with linear mixed models||||0.05
73957420|NCT00404079|147450931|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|||||||0.05
73957421|NCT01120275|147450934|SUPERIORITY_OR_OTHER||6-month PFS|0.09|||||TWO_SIDED|95.0|0.02|0.22||||||6-month progression free survival (PFS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.||0.22|0.02|
73957422|NCT01120275|147450935|SUPERIORITY_OR_OTHER||1-year OS|0.5|||||TWO_SIDED|95.0|0.32|0.66||||||1-year overall survival (OS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.||0.66|0.32|
73957423|NCT01335932|147450948|OTHER|||||||0.0001|||||||Fisher Exact|||||||.0001
73957424|NCT01335932|147450949|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
73957425|NCT01335932|147450955|OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
73957426|NCT01335932|147450956|OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
73957427|NCT01335932|147450957|OTHER|||||||0.1|||||||Fisher Exact|||||||0.10
73957428|NCT01335932|147450958|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
73957429|NCT01335932|147450959|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
73957430|NCT01335932|147450960|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73957431|NCT01335932|147450961|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
73957432|NCT01335932|147450962|OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
73957433|NCT01335932|147450963|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
73957434|NCT01335932|147450964|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
73957435|NCT01335932|147450965|OTHER|||||||0.63|||||||t-test, 2 sided|||||||0.63
73957436|NCT01335932|147450966|OTHER|||||||0.51|||||||t-test, 2 sided|||||||0.51
73957437|NCT01335932|147450967|OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
73957438|NCT01335932|147450968|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
73957439|NCT01335932|147450969|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
73957440|NCT01335932|147450970|OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
73957441|NCT01335932|147450971|OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
73957442|NCT01335932|147450972|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
73957443|NCT01335932|147450973|OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
73957444|NCT01335932|147450974|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
73957445|NCT01335932|147450975|OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
73957446|NCT01335932|147450976|OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
73957447|NCT01335932|147450977|OTHER|||||||0.8|||||||t-test, 2 sided|||||||0.80
73957448|NCT01335932|147450978|OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
73957449|NCT01335932|147450979|OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
73957450|NCT01335932|147450980|OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
73957451|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-4.52|3.17||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.||3.17|-4.52|
73957452|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.06|||||TWO_SIDED|98.25|-3.94|4.38||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococcal serotype 4.||4.38|-3.94|
73878574|NCT02649556|147296749|OTHER||LS Mean Difference|-0.413|||||TWO_SIDED|95.0|-0.694|-0.131||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of White Blood Cell counts between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|-0.131|-0.694|
73957453|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||TWO_SIDED|98.25|-4.63|3.19||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.||3.19|-4.63|
74038928|NCT01595438|147631061|SUPERIORITY_OR_OTHER||Diff of favorable response rates|9.7|||||TWO_SIDED|95.0|1.72|17.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||17.55|1.72|
74038929|NCT01595438|147631062|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.4|||||TWO_SIDED|95.0|-4.07|1.02|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.02|-4.07|
73957454|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.69|||||TWO_SIDED|98.25|-9.4|10.99||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.||10.99|-9.4|
73957455|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.65|||||TWO_SIDED|98.25|-2.7|4.71||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.||4.71|-2.7|
73957456|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||TWO_SIDED|98.25|-5.05|3.82||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.||3.82|-5.05|
73957457|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.65|||||TWO_SIDED|98.25|-4.68|3.15||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.||3.15|-4.68|
73957458|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||TWO_SIDED|98.25|-5.04|3.85||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.||3.85|-5.04|
73957459|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||TWO_SIDED|98.25|-4.6|3.14||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.||3.14|-4.6|
73957460|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.08||||||98.25|-7.66|8.1||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.||8.1|-7.66|
74038930|NCT01595438|147631063|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-4.23|4.03|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.03|-4.23|
74007179|NCT03672461|147564166|SUPERIORITY||Model based LS mean difference|0.03||||0.757|TWO_SIDED|95.0|-0.15|0.2|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.2|-0.15|0.757
74007180|NCT03672461|147564167|SUPERIORITY||Model based LS mean difference|0.22||||0.048|TWO_SIDED|95.0|0.0|0.45|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.45|0|0.048
74038931|NCT01595438|147631064|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.3|||||TWO_SIDED|95.0|-3.71|6.3|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.30|-3.71|
74038932|NCT01595438|147631065|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.3|||||TWO_SIDED|95.0|-3.64|0.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.55|-3.64|
74038933|NCT01595438|147631066|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.2|||||TWO_SIDED|95.0|-2.03|4.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.56|-2.03|
74038934|NCT01595438|147631067|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.2|||||TWO_SIDED|95.0|-2.9|7.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.24|-2.90|
74091303|NCT00472797|147736538|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||P-value denotes differences between treatment groups in change in diameter of injection site redness from baseline to week 12.|ANOVA|||Analysis evaluates differences between treatment groups in change in diameter of injection site redness from baseline to week 12.||||0.899
74091304|NCT00472797|147736539|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 12||||<0.001
74091305|NCT00472797|147736539|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 36||||0.234
74091306|NCT00472797|147736539|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 1||||0.001
74091307|NCT00472797|147736539|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 3||||0.004
74007181|NCT03672461|147564168|SUPERIORITY||Model based LS mean difference|0.82||||0.911|TWO_SIDED|95.0|-13.6|15.23|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||15.23|-13.6|0.911
74038935|NCT01595438|147631068|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.9|||||TWO_SIDED|95.0|-4.3|0.04|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.04|-4.30|
74038936|NCT01595438|147631069|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.1|||||TWO_SIDED|95.0|-2.07|4.32|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.32|-2.07|
74038937|NCT01595438|147631070|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.0|||||TWO_SIDED|95.0|-2.94|6.91|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.91|-2.94|
74038938|NCT01595438|147631071|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-1.99|1.61|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.61|-1.99|
74091308|NCT00472797|147736539|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Exisit Visit LOCF||||0.036
74091309|NCT00472797|147736539|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 12||||0.002
74091310|NCT00472797|147736539|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 36||||0.468
74091311|NCT00472797|147736539|SUPERIORITY_OR_OTHER|||||||0.602||95.0|||||t-test, 2 sided|Paired||Mental Component - Change from Baseline to Extension Visit 1||||0.602
74091312|NCT00472797|147736539|SUPERIORITY_OR_OTHER|||||||0.414||95.0|||||t-test, 2 sided|Paired||Change from Baseline to Extension Visit 3||||0.414
74091313|NCT00472797|147736539|SUPERIORITY_OR_OTHER|||||||0.991||95.0|||||t-test, 2 sided|Paired||Change from Baseline to Exit Visit LOCF||||0.991
74091314|NCT00706381|147736548|SUPERIORITY||Percent change from placebo|7.87|STANDARD_DEVIATION|9.2||0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.0001
74091315|NCT00706381|147736548|SUPERIORITY||Percent change from placebo|9.25|STANDARD_DEVIATION|8.3|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
74091316|NCT00706381|147736548|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|6.2||0.89|TWO_SIDED||||||Percent change from placebo|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.89
74091317|NCT00706381|147736548|SUPERIORITY||Percent change from placebo|-0.3|STANDARD_DEVIATION|7.2||0.41|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.41
74091318|NCT00706381|147736549|SUPERIORITY||Percent change from placebo|40.0|STANDARD_DEVIATION|72.8||0.096|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.096
73957461|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-4.52|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.||2.91|-4.52|
74007182|NCT03672461|147564169|SUPERIORITY||Model based LS mean difference|3.13||||0.041|TWO_SIDED|95.0|0.13|6.13|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||6.13|0.13|0.041
73957462|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||TWO_SIDED|98.25|-4.57|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 4.||2.91|-4.57|
74007183|NCT03672461|147564170|SUPERIORITY||Model based LS mean difference|0.07||||0.564|TWO_SIDED|95.0|-0.16|0.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.3|-0.16|0.564
74007184|NCT03672461|147564171|SUPERIORITY||Model based LS mean difference|0.3||||0.764|TWO_SIDED|95.0|-1.69|2.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.3|-1.69|0.764
73957463|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||TWO_SIDED|98.25|-4.63|2.92||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.||2.92|-4.63|
73957464|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-2.38|||||TWO_SIDED|98.25|-12.02|7.22||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.||7.22|-12.02|
73957465|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||TWO_SIDED|98.25|-3.34|3.48||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.||3.48|-3.34|
73957466|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-1.27|||||TWO_SIDED|98.25|-5.66|2.32||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.||2.32|-5.66|
73957467|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||TWO_SIDED|98.25|-4.08|4.12||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.||4.12|-4.08|
73957468|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-5.08|3.54||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.||3.54|-5.08|
74007185|NCT03672461|147564172|SUPERIORITY||Model based LS mean difference|-0.12||||0.883|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.53|-1.78|0.883
74007186|NCT03672461|147564173|SUPERIORITY||Model based LS mean difference|-0.11||||0.753|TWO_SIDED|95.0|-0.83|0.6|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.6|-0.83|0.753
74007187|NCT03672461|147564174|SUPERIORITY||Model based LS mean difference|-0.28||||0.685|TWO_SIDED|95.0|-1.63|1.07|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.07|-1.63|0.685
74007188|NCT03672461|147564175|SUPERIORITY||Model based LS mean difference|0.24||||0.691|TWO_SIDED|95.0|-0.95|1.43|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.43|-0.95|0.691
73878575|NCT02649556|147296750|OTHER||LS Mean Difference|0.914|||||TWO_SIDED|95.0|-0.339|2.17||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of FEV1 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|2.17|-0.339|
73957469|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.67|||||TWO_SIDED|98.25|-3.4|5.2||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.||5.2|-3.4|
74091319|NCT00706381|147736549|SUPERIORITY||Percent change from placebo|260.4|STANDARD_DEVIATION|191.7|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
73957470|NCT01235949|147451014|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|2.73|||||TWO_SIDED|98.25|-5.3|11.04||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.||11.04|-5.3|
73957471|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||TWO_SIDED|99.8|0.71|1.29||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 1.||1.29|0.71|
73957472|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.77|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 4.||1.35|0.77|
73957473|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.06|||||TWO_SIDED|99.8|0.8|1.41||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 5.||1.41|0.8|
73957474|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.12|||||TWO_SIDED|99.8|0.72|1.74||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.||1.74|0.72|
73957475|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.04|||||TWO_SIDED|99.8|0.79|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.||1.35|0.79|
73957476|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||TWO_SIDED|99.8|0.7|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.||1.31|0.7|
73957477|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||TWO_SIDED|99.8|0.71|1.4||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 14.||1.4|0.71|
73957478|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.89|||||TWO_SIDED|99.8|0.6|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.||1.31|0.6|
73957479|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.23|||||TWO_SIDED|99.8|0.87|1.75||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.||1.75|0.87|
74091320|NCT00706381|147736549|SUPERIORITY||Percent change from placebo|16.4|STANDARD_DEVIATION|56.3||0.83|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.83
74007189|NCT03672461|147564176|SUPERIORITY||Model based LS mean difference|0.19||||0.743|TWO_SIDED|95.0|-0.95|1.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.34|-0.95|0.743
74007190|NCT03672461|147564177|SUPERIORITY||Model based LS mean difference|0.98||||0.043|TWO_SIDED|95.0|0.03|1.93|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.93|0.03|0.043
74007191|NCT03672461|147564178|SUPERIORITY||Model based LS mean difference|0.99||||0.689|TWO_SIDED|95.0|-3.87|5.84|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||5.84|-3.87|0.689
74007192|NCT03672461|147564179|SUPERIORITY||Model based LS mean difference|-3.4||||0.276|TWO_SIDED|95.0|-9.54|2.74|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.74|-9.54|0.276
74007193|NCT03672461|147564180|SUPERIORITY||Model based LS mean difference|0.1||||0.448|TWO_SIDED|95.0|-0.15|0.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.34|-0.15|0.448
74007194|NCT03672461|147564181|SUPERIORITY||Model based LS mean difference|-0.29||||0.319|TWO_SIDED|95.0|-0.86|0.28|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.28|-0.86|0.319
74007195|NCT03672461|147564182|SUPERIORITY||Model based LS mean difference|1.21||||0.747|TWO_SIDED|95.0|-6.25|8.67|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||8.67|-6.25|0.747
74007196|NCT03672461|147564183|SUPERIORITY||Model based LS mean difference|-2.76||||0.459|TWO_SIDED|95.0|-10.2|4.65|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||4.65|-10.2|0.459
74007197|NCT03672461|147564184|SUPERIORITY||Model based LS mean difference|-2.0||||0.556|TWO_SIDED|95.0|-10.2|4.65|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||4.65|-10.2|0.556
74007198|NCT03672461|147564185|SUPERIORITY||Model based LS mean difference|-3.26||||0.516|TWO_SIDED|95.0|-13.2|6.7|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||6.7|-13.2|0.516
74007199|NCT03672461|147564186|SUPERIORITY||Model based LS mean difference|-2.38||||0.154|TWO_SIDED|95.0|-5.68|0.91|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.91|-5.68|0.154
74007200|NCT03672461|147564187|SUPERIORITY||Model based LS mean difference|-2.22||||0.375|TWO_SIDED|95.0|-7.17|2.72|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.72|-7.17|0.375
74007201|NCT03672461|147564188|SUPERIORITY||Model based LS mean difference|-1.75||||0.287|TWO_SIDED|95.0|-5.0|1.5|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix||||1.5|-5|0.287
74007202|NCT03672461|147564189|SUPERIORITY||Model based LS mean difference|-1.63||||0.147|TWO_SIDED|95.0|-3.85|0.58||adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix|Mixed Models Analysis|||||0.58|-3.85|0.147
74007203|NCT03672461|147564190|SUPERIORITY||Model based LS mean difference|-1.37||||0.495|TWO_SIDED|95.0|-5.36|2.61|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix||||2.61|-5.36|0.495
74007204|NCT03672461|147564191|SUPERIORITY||Model based LS mean difference|-2.82||||0.303|TWO_SIDED|95.0|-8.22|2.59|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.59|-8.22|0.303
74007205|NCT03672461|147564192|SUPERIORITY||Model based LS mean difference|2.97||||0.196|TWO_SIDED|95.0|-1.56|7.51|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||7.51|-1.56|0.196
74007206|NCT04667247|147564202|OTHER||ratio of frequencies|0.94||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
74007207|NCT04667247|147564205|OTHER||ratio of frequencies|1.022||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
74007208|NCT04667247|147564207|OTHER||ratio of frequencies|4.828||||0.061|TWO_SIDED||||||Chi-squared, Corrected|||||||0.061
74007209|NCT04667247|147564208|OTHER||ratio of frequencies|3.526||||0.1|TWO_SIDED||||||Chi-squared, Corrected|||||||.100
74007210|NCT04667247|147564209|OTHER||ratio of frequencies|0.005||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
74007211|NCT04667247|147564210|OTHER||ratio of frequencies|3.036||||0.162|TWO_SIDED||||||Chi-squared, Corrected|||||||.162
74007212|NCT04667247|147564212|OTHER||ratio of frequencies|0.151||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.00
74007213|NCT04667247|147564213|SUPERIORITY||F value|1.908||||0.174|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.174
74007214|NCT04667247|147564214|SUPERIORITY||F value|0.038||||0.846|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.846
74007215|NCT04667247|147564215|SUPERIORITY||F value|0.041||||0.841|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||.841
74007216|NCT04667247|147564216|SUPERIORITY||F value|0.261||||0.612|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.612
74007217|NCT04667247|147564217|SUPERIORITY||F value|0.161||||0.69|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.690
74007218|NCT04667247|147564218|SUPERIORITY||F value|2.671||||0.109|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.109
74038939|NCT01595438|147631072|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|3.7|||||TWO_SIDED|95.0|0.41|7.16|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.16|0.41|
74007219|NCT04667247|147564219|SUPERIORITY||F value|0.039||||0.844|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.844
74007220|NCT04667247|147564220|SUPERIORITY||F value|4.28||||0.044|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.044
74007221|NCT04667247|147564221|SUPERIORITY||F value|0.001||||0.989|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||.989
74007222|NCT04667247|147564222|SUPERIORITY||F value|7.186||||0.01|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.010
74007223|NCT04667247|147564223|SUPERIORITY||F value|0.345||||0.56|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.560
74007224|NCT04667247|147564224|SUPERIORITY||F value|0.143||||0.707|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.707
73957480|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.97|||||TWO_SIDED|99.8|0.66|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.||1.44|0.66|
74007225|NCT04667247|147564225|SUPERIORITY||F value|0.09||||0.765|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||0.765
74007226|NCT04667247|147564226|SUPERIORITY||F value|7.835||||0.005|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.005
74007227|NCT04667247|147564227|SUPERIORITY||F value|16.56|||<|0.001|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||<0.001
74007228|NCT01444651|147564228|SUPERIORITY_OR_OTHER||beta estimate|-1.25|STANDARD_ERROR_OF_MEAN|1.29||0.34|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in HOMA-IR (3 month minus baseline value), comparing tadalafil versus placebo groups after adjusting for baseline HOMA-IR.||||0.34
74007229|NCT01444651|147564229|SUPERIORITY_OR_OTHER||beta estimate|0.96|STANDARD_ERROR_OF_MEAN|0.68||0.18|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in Matsuda Index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.||||0.18
74007230|NCT01444651|147564230|SUPERIORITY_OR_OTHER||beta estimate|-0.18|STANDARD_ERROR_OF_MEAN|0.58||0.76|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the difference in EndoPAT (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline values.||||0.76
74007231|NCT01444651|147564231|SUPERIORITY_OR_OTHER||beta estimate|1.48|STANDARD_ERROR_OF_MEAN|0.77||0.06|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in insulinogenic index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.||||0.06
74007232|NCT01444651|147564232|SUPERIORITY_OR_OTHER||beta estimate|3.76|STANDARD_ERROR_OF_MEAN|1.38||0.009|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in oral disposition index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.||||0.009
74007233|NCT01444651|147564233|SUPERIORITY_OR_OTHER||beta estimate|8.09|STANDARD_ERROR_OF_MEAN|4.05||0.05|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in Matsuda disposition index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.||||0.05
74007234|NCT01436071|147564234|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12||||0.012|TWO_SIDED|95.0|0.026|0.213|||ANCOVA|||||0.213|0.026|0.012
74007235|NCT01215175|147564241|OTHER||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen \& Nurminen method|||28.3|-7.4|
74007236|NCT01215175|147564242|OTHER||Risk Difference (RD)|8.2||||||95.0|-7.9|26.6|||||Miettinen \& Nurminen method|||26.6|-7.9|
74007237|NCT01215175|147564242|OTHER||Risk Difference (RD)|3.6||||||95.0|-15.5|22.9|||||Miettinen \& Nurminen method|||22.9|-15.5|
74007238|NCT01215175|147564243|OTHER||Risk Difference (RD)|0.0||||||95.0|-11.5|11.5|||||Miettinen \& Nurminen method|||11.5|-11.5|
74007239|NCT01215175|147564244|OTHER||Risk Difference (RD)|0.0||||||95.0|-12.2|10.6|||||Miettinen \& Nurminen method|||10.6|-12.2|
74007240|NCT01215175|147564244|OTHER||Risk Difference (RD)|0.0||||||95.0|-12.3|12.3|||||Miettinen \& Nurminen method|||12.3|-12.3|
74007241|NCT01215175|147564245|OTHER||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen \& Nurminen method|||28.3|-7.4|
74007242|NCT01215175|147564246|OTHER||Risk Difference (RD)|9.8||||||95.0|-10.6|30.9|||||Miettinen \& Nurminen method|||30.9|-10.6|
74007243|NCT01215175|147564246|OTHER||Risk Difference (RD)|3.6||||||95.0|-19.1|26.0|||||Miettinen \& Nurminen method|||26.0|-19.1|
74007244|NCT00998426|147564259|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||This is the p value for the meter by time interaction|Random intercept model|||A random intercept model was used to fit the five subjects' glucose reading data over time. The fixed effect glucose meters, time effect and their interactions were included in the model.||||0.59
74007245|NCT01158651|147564260|SUPERIORITY|The treatment regimen was considered promising for further study if after 48 weeks of treatment there was at least a 25% response rate compared to an expected response rate of 5% or less, which was considered evidence of an unpromising regimen. Assuming the true response rate is 5%, the binomial distribution was used to calculate Type I errors and power.|Proportion responding|0.682|||<|0.001|TWO_SIDED|95.0|0.4872|0.8764|||Exact test|||||0.8764|0.4872|<0.001
74038940|NCT01595438|147631073|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|4.0|||||TWO_SIDED|95.0|-1.0|9.05|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||9.05|-1.00|
74038941|NCT01595438|147631074|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|0.0|||||TWO_SIDED|95.0|-10.4|10.1|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.1|-10.4|
74038942|NCT01595438|147631075|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.4|||||TWO_SIDED|95.0|-7.8|10.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.2|-7.8|
74038943|NCT01595438|147631076|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.2|||||TWO_SIDED|95.0|-7.5|9.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||9.2|-7.5|
74038944|NCT01595438|147631077|SUPERIORITY_OR_OTHER||Diff of favorable response rates|2.0|||||TWO_SIDED|95.0|-13.18|16.89|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||16.89|-13.18|
74007246|NCT04464265|147564264|OTHER|Our study adopted a within-subject design, which is not a randomized controlled trial (RCT). The P-value below indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli.|Mean Difference (Net)|-3.0|STANDARD_DEVIATION|2.0|<|0.001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = BOLD Response During Sedation - BOLD Response During Baseline|The null hypothesis is no difference in BOLD response between sedated state and baseline. For an fMRI study of cognitive function, Desmond and Glover (J. Neurosci. Methods., 2002) reported that about 25 subjects are necessary to achieve 80% power for a 0.5% increase of activity. We analyzed 27 subjects that fulfilled the suggested optimal group size for reliable statistics in functional MRI studies (also see Thirion et al., Neuroimage, 2007).||||<0.001
74007247|NCT04464265|147564265|OTHER|Our study adopted a within-subject design, which is not a randomized controlled trial (RCT). The P-value below indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli.|Mean Difference (Net)|-2.72|STANDARD_DEVIATION|3.17|<|0.001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline|||||<0.001
74007248|NCT01063829|147564266|SUPERIORITY_OR_OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
74007249|NCT01063829|147564266|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
74007250|NCT01063829|147564266|SUPERIORITY_OR_OTHER|||||||0.321|||||||Fisher Exact|||||||0.321
74007251|NCT01063829|147564267|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|||||||0.002
74007252|NCT01063829|147564267|SUPERIORITY_OR_OTHER|||||||0.126|||||||Log Rank|||||||0.126
74007253|NCT01063829|147564267|SUPERIORITY_OR_OTHER|||||||0.148|||||||Log Rank|||||||0.148
74007254|NCT01063829|147564268|SUPERIORITY_OR_OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
74007255|NCT01063829|147564268|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
74007256|NCT01063829|147564268|SUPERIORITY_OR_OTHER|||||||0.321|||||||Fisher Exact|||||||0.321
74007257|NCT00056862|147564292|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||Null hypothesis: first phase decline in HCV RNA are the same for the two groups||||0.002
74007258|NCT00056862|147564294|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: the second phase slopes of HCV RNA are the same for the two groups||||0.2
74007259|NCT00056862|147564295|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|95.0|||||Log Rank|||Null hypothesis: the time to negativity for the two groups are same||||0.047
74007260|NCT01829360|147564296|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|The significance of fixed effects (e.g.,treatment) was evaluated using Wald tests||||||<0.05
74038945|NCT01595438|147631078|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.0|||||TWO_SIDED|95.0|-10.03|25.21|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||25.21|-10.03|
74007261|NCT01829360|147564296|OTHER|A secondary analysis was performed to examine individual differences in treatment outcomes. This was done collapsed across all arms because the difference between the arms/treatments was not significant in the primary analysis. This was done by adding predictors to the primary analysis model to determine if learner characteristics were significantly related to growth in word defining. All continuous learner characteristics were grand mean centered.|||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
74007262|NCT01829360|147564297|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||The interim definition data were analyzed with the primary pre-/post-definition data to capture growth across the entire treatment period.||||<0.05
74007263|NCT02378220|147564309|OTHER||Risk Ratio (RR)|0.65||||0.21|TWO_SIDED|95.0|0.32|1.28||P-value for 30 days measure.|Regression, Poisson|||||1.28|0.32|0.21
74007264|NCT02378220|147564309|OTHER||Risk Ratio (RR)|0.48||||0.007|TWO_SIDED|95.0|0.27|0.82||P-Value for 60 days measure|Regression, Poisson|||||0.82|0.27|0.007
74007265|NCT02378220|147564310|OTHER||Risk Ratio (RR)|0.62||||0.16|TWO_SIDED|95.0|0.31|1.21||P-Value for 30 days measure|Regression, Poisson|||||1.21|0.31|0.16
74007266|NCT02378220|147564310|OTHER||Risk Ratio (RR)|0.58||||0.045|TWO_SIDED|95.0|0.34|0.99|||Regression, Poisson|||||0.99|0.34|0.045
74007267|NCT02378220|147564311|OTHER||Hazard Ratio (HR)|0.59||||0.1|TWO_SIDED|95.0|0.31|1.12|||Log Rank|||||1.12|0.31|0.10
74007268|NCT02378220|147564312|OTHER||Hazard Ratio (HR)|0.6||||0.09|TWO_SIDED|95.0|0.33|1.1|||Log Rank|||||1.10|0.33|0.09
74038946|NCT01595438|147631079|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.5|||||TWO_SIDED|95.0|-9.91|24.01|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||24.01|-9.91|
74007269|NCT00578786|147564325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0|STANDARD_DEVIATION|74.28|||TWO_SIDED|95.0|22.7|53.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||53.3|22.7|
74007270|NCT00578786|147564325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.5|STANDARD_DEVIATION|78.55|||TWO_SIDED|95.0|21.1|43.8|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||43.8|21.1|
74007271|NCT00578786|147564325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|40.9|STANDARD_DEVIATION|72.85|||TWO_SIDED|95.0|26.1|55.7|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||55.7|26.1|
74007272|NCT00578786|147564325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.0|STANDARD_DEVIATION|75.97|||TWO_SIDED|95.0|28.3|43.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.|||43.7|28.3|
74007273|NCT00578786|147564326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.9|STANDARD_DEVIATION|96.14|||TWO_SIDED|95.0|5.1|44.7|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||44.7|5.1|
74038947|NCT01595438|147631080|SUPERIORITY_OR_OTHER|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.038
74038948|NCT01595438|147631081|SUPERIORITY_OR_OTHER|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.129
74038949|NCT01595438|147631082|SUPERIORITY_OR_OTHER|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.080
74038950|NCT01595438|147631083|SUPERIORITY_OR_OTHER|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.155
74038951|NCT01784588|147631122|NON_INFERIORITY|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Adjusted Difference in Percentages|-0.4|||||TWO_SIDED|90.0|-8.2|7.4||Non-inferiority was evaluated using a two-sided 90% confidence interval (CI) for the treatment difference (SIS minus TMUS). The CI was calculated based on the pooling of treatment differences across propensity score strata for a binary endpoint.||||Available Cases Only - Intent-to-Treat||7.4|-8.2|
74038952|NCT01784588|147631122|NON_INFERIORITY|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Unadjusted Treatment Difference (%)|1.5|||||TWO_SIDED|90.0|-5.4|8.4||Non-inferiority was evaluated using a two-sided 90% confidence interval (CI) for the treatment difference (SIS minus TMUS). The CI was calculated based on the pooling of treatment differences across propensity score strata for a binary endpoint.||||Available Cases Only - Intent-to-Treat||8.4|-5.4|
73957481|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.9|||||TWO_SIDED|99.8|0.67|1.21||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 1.||1.21|0.67|
73957482|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||TWO_SIDED|99.8|0.76|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 4.||1.32|0.76|
73957483|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||TWO_SIDED|99.8|0.66|1.14||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 5.||1.14|0.66|
73957484|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.28|||||TWO_SIDED|99.8|0.83|1.97||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.||1.97|0.83|
73957485|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.8|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.||1.31|0.8|
73957486|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.92|||||TWO_SIDED|99.8|0.69|1.22||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.||1.22|0.69|
73957487|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.95|||||TWO_SIDED|99.8|0.68|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 14.||1.32|0.68|
73957488|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.88|||||TWO_SIDED|99.8|0.6|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.||1.27|0.6|
73957489|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.72|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.||1.44|0.72|
74007274|NCT00578786|147564326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.9|STANDARD_DEVIATION|94.5|||TWO_SIDED|95.0|14.2|41.6|||||Applies to Ambrisentan 5.0 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||41.6|14.2|
74007275|NCT00578786|147564326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.2|STANDARD_DEVIATION|72.97|||TWO_SIDED|95.0|22.4|52.0|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||52.0|22.4|
74007276|NCT00578786|147564326|SUPERIORITY_OR_OTHER||Median Difference (Net)|29.5|STANDARD_DEVIATION|89.81|||TWO_SIDED|95.0|20.4|38.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.|||38.7|20.4|
74007277|NCT00578786|147564327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|97.48|||TWO_SIDED|95.0|-13.4|26.8|||||Applies to Ambrisentan 2.5 mg group only. LOCF method of imputation.|||26.8|-13.4|
74007278|NCT00578786|147564327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.2|STANDARD_DEVIATION|100.69|||TWO_SIDED|95.0|8.7|37.8|||||Applies to Ambrisentan 5 mg group only. LOCF method of imputation.|||37.8|8.7|
74007279|NCT00578786|147564327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0|STANDARD_DEVIATION|84.38|||TWO_SIDED|95.0|10.9|45.1|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation.|||45.1|10.9|
74007280|NCT00578786|147564327|SUPERIORITY_OR_OTHER||Median Difference (Net)|20.3|STANDARD_DEVIATION|96.05|||TWO_SIDED|95.0|10.6|30.1|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||30.1|10.6|
74007281|NCT00578786|147564328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_DEVIATION|95.21|||TWO_SIDED|95.0|-18.9|20.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||20.3|-18.9|
74007282|NCT00578786|147564328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.8|STANDARD_DEVIATION|101.22|||TWO_SIDED|95.0|4.2|33.5|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||33.5|4.2|
74007283|NCT00578786|147564328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.8|STANDARD_DEVIATION|87.07|||TWO_SIDED|95.0|10.1|45.4|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||45.4|10.1|
74038953|NCT04904614|147631135|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
74038954|NCT04904614|147631136|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
74038955|NCT04904614|147631137|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.6
74038956|NCT04904614|147631139|SUPERIORITY|||||||0.97|||||||Chi-squared|||||||0.97
74038957|NCT02806947|147631165|OTHER|No formal hypothesis test was planned or performed for comparing Day 28 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 90% confidence interval.|Risk Difference (RD)|-0.082|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|90.0|-0.223|0.059|||||The risk difference estimate is the observed proportion of Day 28 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|The primary objective of this Phase II trial was to describe the proportion of patients with Day 28 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 90% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.||0.059|-0.223|
74038958|NCT02806947|147631165|OTHER|No formal hypothesis test was planned or performed for comparing Day 56 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 95% confidence interval.|Risk Difference (RD)|-0.152|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|95.0|-0.315|0.011|||||The risk difference estimate is the observed proportion of Day 56 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|A secondary objective of this Phase II trial was to describe the proportion of patients with Day 56 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 95% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.||0.011|-0.315|
74038959|NCT02806947|147631166|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with CR/PR and steroid dose of 0.25mg/kg/day or less at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||< 0.001
74007284|NCT00578786|147564328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.6|STANDARD_DEVIATION|96.54|||TWO_SIDED|95.0|6.8|26.4|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||26.4|6.8|
74007285|NCT00578786|147564330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_DEVIATION|2.254|||TWO_SIDED|95.0|-0.55|0.38|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.38|-0.55|
74007286|NCT00578786|147564330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|STANDARD_DEVIATION|2.45|||TWO_SIDED|95.0|-0.94|-0.23|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.23|-0.94|
74007287|NCT00578786|147564330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-1.0|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.03|-1.00|
73957490|NCT01235949|147451015|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||TWO_SIDED|99.8|0.58|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.||1.27|0.58|
74038960|NCT02806947|147631167|SUPERIORITY|||||||0.32||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 28 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.||||0.320
73957491|NCT01235949|147451016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for protein D.|GMC ratio|0.94|||||TWO_SIDED|99.8|0.69|1.28||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.||1.28|0.69|
73957492|NCT01235949|147451016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for protein D.|GMC ratio|0.87|||||TWO_SIDED|99.8|0.64|1.17||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.||1.17|0.64|
73957493|NCT00383188|147451039|SUPERIORITY||Difference in percentage|8.05|STANDARD_ERROR_OF_MEAN|7.97||0.3131|TWO_SIDED|95.0|-7.565|23.664|||Chi-squared|||||23.664|-7.565|0.3131
73957494|NCT00383188|147451039|SUPERIORITY||Difference in percentage|10.81|STANDARD_ERROR_OF_MEAN|7.86||0.1719|TWO_SIDED|95.0|-4.602|26.224|||Chi-squared|||||26.224|-4.602|0.1719
73957495|NCT00383188|147451039|SUPERIORITY||Difference in percentage|9.83|STANDARD_ERROR_OF_MEAN|9.16||0.2783|TWO_SIDED|95.0|-8.123|27.799|||Chi-squared|||||27.799|-8.123|0.2783
73957496|NCT00383188|147451039|SUPERIORITY||Difference in percentage|8.92|STANDARD_ERROR_OF_MEAN|9.43||0.3381|TWO_SIDED|95.0|-9.566|27.404|||Chi-squared|||||27.404|-9.566|0.3381
73957497|NCT00383188|147451040|SUPERIORITY||Difference in percentage|1.04|STANDARD_ERROR_OF_MEAN|5.96||0.8619|TWO_SIDED|90.0|-8.733|10.845|||Chi-squared|||Week 1||10.845|-8.733|0.8619
73957498|NCT00383188|147451040|SUPERIORITY||Difference in percentage|7.24|STANDARD_ERROR_OF_MEAN|6.33||0.2546|TWO_SIDED|90.0|-3.176|17.651|||Chi-squared|||Week 1||17.651|-3.176|0.2546
73957499|NCT00383188|147451040|SUPERIORITY||Difference in percentage|14.02|STANDARD_ERROR_OF_MEAN|7.96||0.0644|TWO_SIDED|90.0|0.921|27.115|||Chi-squared|||Week 1||27.115|0.921|0.0644
73957500|NCT00383188|147451040|SUPERIORITY||Difference in percentage|1.5|STANDARD_ERROR_OF_MEAN|7.07||0.8304|TWO_SIDED|90.0|-10.13|13.125|||Chi-squared|||Week 1||13.125|-10.13|0.8304
73957501|NCT00383188|147451040|SUPERIORITY||Difference in percentage|6.11|STANDARD_ERROR_OF_MEAN|7.45||0.4123|TWO_SIDED|90.0|-6.15|18.371|||Chi-squared|||Week 2||18.371|-6.150|0.4123
73957502|NCT00383188|147451040|SUPERIORITY||Difference in percentage|5.41|STANDARD_ERROR_OF_MEAN|7.29||0.4591|TWO_SIDED|90.0|-6.581|17.392|||Chi-squared|||Week 2||17.392|-6.581|0.4591
73957503|NCT00383188|147451040|SUPERIORITY||Difference in percentage|16.58|STANDARD_ERROR_OF_MEAN|8.93||0.0585|TWO_SIDED|90.0|1.89|31.28|||Chi-squared|||Week 2||31.280|1.890|0.0585
73957504|NCT00383188|147451040|SUPERIORITY||Difference in percentage|15.68|STANDARD_ERROR_OF_MEAN|9.21||0.0808|TWO_SIDED|90.0|0.522|30.829|||Chi-squared|||Week 2||30.829|0.522|0.0808
73957505|NCT00383188|147451040|SUPERIORITY||Difference in percentage|4.86|STANDARD_ERROR_OF_MEAN|7.62||0.524|TWO_SIDED|90.0|-7.684|17.398|||Chi-squared|||Week 4||17.398|-7.684|0.5240
73957506|NCT00383188|147451040|SUPERIORITY||Difference in percentage|14.86|STANDARD_ERROR_OF_MEAN|7.72||0.0571|TWO_SIDED|90.0|2.172|27.588|||Chi-squared|||Week 4||27.588|2.172|0.0571
73957507|NCT00383188|147451040|SUPERIORITY||Difference in percentage|16.15|STANDARD_ERROR_OF_MEAN|9.08||0.0712|TWO_SIDED|90.0|1.222|31.087|||Chi-squared|||Week 4||31.087|1.222|0.0712
73957508|NCT00383188|147451040|SUPERIORITY||Difference in percentage|20.47|STANDARD_ERROR_OF_MEAN|9.43||0.0279|TWO_SIDED|90.0|4.956|35.99|||Chi-squared|||Week 4||35.990|4.956|0.0279
73957509|NCT00383188|147451040|SUPERIORITY||Difference in Percentage|-2.1|STANDARD_ERROR_OF_MEAN|7.67||0.7848|TWO_SIDED|90.0|-14.71|10.515|||Chi-squared|||Week 8||10.515|-14.71|0.7848
73957510|NCT00383188|147451040|SUPERIORITY||Difference in percentage|14.86|STANDARD_ERROR_OF_MEAN|7.91||0.0632|TWO_SIDED|90.0|1.86|27.869|||Chi-squared|||Week 8||27.869|1.860|0.0632
73957511|NCT00383188|147451040|SUPERIORITY||Difference in percentage|9.83|STANDARD_ERROR_OF_MEAN|9.16||0.2783|TWO_SIDED|90.0|-5.237|24.893|||Chi-squared|||Week 8||24.893|-5.237|0.2783
73957512|NCT00383188|147451040|SUPERIORITY||Difference in percentage|16.42|STANDARD_ERROR_OF_MEAN|9.55||0.0828|TWO_SIDED|90.0|0.703|32.135|||Chi-squared|||Week 8||32.135|0.703|0.0828
73957513|NCT00383188|147451040|SUPERIORITY||Difference in percentage|-2.72|STANDARD_ERROR_OF_MEAN|8.54||0.7505|TWO_SIDED|90.0|-16.77|11.328|||Chi-squared|||Week 16||11.328|-16.77|0.7505
73957514|NCT00383188|147451040|SUPERIORITY||Difference in percentage|1.43|STANDARD_ERROR_OF_MEAN|8.35||0.8641|TWO_SIDED|90.0|-12.3|15.156|||Chi-squared|||Week 16||15.156|-12.30|0.8641
73957515|NCT00383188|147451040|SUPERIORITY||Difference in percentage|3.31|STANDARD_ERROR_OF_MEAN|9.99||0.7399|TWO_SIDED|90.0|-13.12|19.734|||Chi-squared|||Week 16||19.734|-13.12|0.7399
73957516|NCT00383188|147451040|SUPERIORITY||Difference in percentage|-12.48|STANDARD_ERROR_OF_MEAN|9.42||0.1996|TWO_SIDED|90.0|-27.98|3.018|||Chi-squared|||Week 16||3.018|-27.98|0.1996
73957517|NCT00383188|147451041|SUPERIORITY||Difference in percentage|1.49|STANDARD_ERROR_OF_MEAN|1.48||0.2982|TWO_SIDED|90.0|-0.944|3.929|||Chi-squared|||Week 1||3.929|-0.944|0.2982
74038961|NCT02806947|147631167|SUPERIORITY|||||||0.014||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 56 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.||||0.014
73957518|NCT00383188|147451041|SUPERIORITY||Difference in percentage|1.41|STANDARD_ERROR_OF_MEAN|1.4||0.3122|TWO_SIDED|90.0|-0.892|3.709|||Chi-squared|||Week 1||3.709|-0.892|0.3122
73957519|NCT00383188|147451041|SUPERIORITY||Difference in percentage|4.65|STANDARD_ERROR_OF_MEAN|3.21||0.0649|TWO_SIDED|90.0|-0.631|9.934|||Chi-squared|||Week 1||9.934|-0.631|0.0649
73957520|NCT00383188|147451041|SUPERIORITY||Difference in percentage|5.13|STANDARD_ERROR_OF_MEAN|3.53||0.0525|TWO_SIDED|90.0|-0.681|10.938|||Chi-squared|||Week 1||10.938|-0.681|0.0525
73957521|NCT00383188|147451041|SUPERIORITY||Difference in percentage|4.45|STANDARD_ERROR_OF_MEAN|3.12||0.1481|TWO_SIDED|90.0|-0.681|9.573|||Chi-squared|||Week 2||9.573|-0.681|0.1481
73957522|NCT00383188|147451041|SUPERIORITY||Difference in percentage|8.11|STANDARD_ERROR_OF_MEAN|3.66||0.0292|TWO_SIDED|90.0|2.093|14.124|||Chi-squared|||Week 2||14.124|2.093|0.0292
73957523|NCT00383188|147451041|SUPERIORITY||Difference in percentage|10.01|STANDARD_ERROR_OF_MEAN|4.97||0.0167|TWO_SIDED|90.0|1.839|18.186|||Chi-squared|||Week 2||18.186|1.839|0.0167
73957524|NCT00383188|147451041|SUPERIORITY||Difference in percentage|11.15|STANDARD_ERROR_OF_MEAN|5.4||0.011|TWO_SIDED|90.0|2.269|20.029|||Chi-squared|||Week 2||20.029|2.269|0.0110
73957525|NCT00383188|147451041|SUPERIORITY||Difference in percentage|-2.51|STANDARD_ERROR_OF_MEAN|3.31||0.455|TWO_SIDED|90.0|-7.959|2.946|||Chi-squared|||Week 4||2.946|-7.959|0.4550
73957526|NCT00383188|147451041|SUPERIORITY||Difference in percentage|8.11|STANDARD_ERROR_OF_MEAN|4.76||0.0919|TWO_SIDED|90.0|0.271|15.946|||Chi-squared|||Week 4||15.946|0.271|0.0919
73957527|NCT00383188|147451041|SUPERIORITY||Difference in percentage|12.78|STANDARD_ERROR_OF_MEAN|6.38||0.0264|TWO_SIDED|90.0|2.28|23.272|||Chi-squared|||Week 4||23.272|2.280|0.0264
73957528|NCT00383188|147451041|SUPERIORITY||Difference in percentage|12.09|STANDARD_ERROR_OF_MEAN|6.56||0.0369|TWO_SIDED|90.0|1.308|22.881|||Chi-squared|||Week 4||22.881|1.308|0.0369
73957529|NCT00383188|147451041|SUPERIORITY||Difference in percentage|-9.17|STANDARD_ERROR_OF_MEAN|4.67||0.0568|TWO_SIDED|90.0|-16.85|-1.482|||Chi-squared|||Week 8||-1.482|-16.85|0.0568
73957530|NCT00383188|147451041|SUPERIORITY||Difference in percentage|4.05|STANDARD_ERROR_OF_MEAN|5.95||0.4961|TWO_SIDED|90.0|-5.727|13.835|||Chi-squared|||Week 8||13.835|-5.727|0.4961
73957531|NCT00383188|147451041|SUPERIORITY||Difference in percentage|6.94|STANDARD_ERROR_OF_MEAN|7.26||0.3212|TWO_SIDED|90.0|-5.008|18.89|||Chi-squared|||Week 8||18.890|-5.008|0.3212
73957532|NCT00383188|147451041|SUPERIORITY||Difference in percentage|1.49|STANDARD_ERROR_OF_MEAN|6.9||0.8274|TWO_SIDED|90.0|-9.87|12.843|||Chi-squared|||Week 8||12.843|-9.870|0.8274
73957533|NCT00383188|147451041|SUPERIORITY||Difference in percentage|5.23|STANDARD_ERROR_OF_MEAN|5.94||0.3774|TWO_SIDED|90.0|-4.538|14.996|||Chi-squared|||Week 12||14.996|-4.538|0.3774
73957534|NCT00383188|147451041|SUPERIORITY||Difference in percentage|9.46|STANDARD_ERROR_OF_MEAN|6.11||0.1246|TWO_SIDED|90.0|-0.591|19.51|||Chi-squared|||Week 12||19.510|-0.591|0.1246
73957535|NCT00383188|147451041|SUPERIORITY||Difference in percentage|8.29|STANDARD_ERROR_OF_MEAN|7.17||0.2257|TWO_SIDED|90.0|-3.502|20.087|||Chi-squared|||Week 12||20.087|-3.502|0.2257
73957536|NCT00383188|147451041|SUPERIORITY||Difference in percentage|5.34|STANDARD_ERROR_OF_MEAN|7.11||0.4336|TWO_SIDED|90.0|-6.355|17.03|||Chi-squared|||Week 12||17.030|-6.355|0.4336
73957537|NCT00383188|147451041|SUPERIORITY||Difference in percentage|-2.07|STANDARD_ERROR_OF_MEAN|7.02||0.7682|TWO_SIDED|90.0|-13.61|9.467|||Chi-squared|||Week 16||9.467|-13.61|0.7682
73957538|NCT00383188|147451041|SUPERIORITY||Difference in percentage|-2.86|STANDARD_ERROR_OF_MEAN|6.76||0.6726|TWO_SIDED|90.0|-13.97|8.257|||Chi-squared|||Week 16||8.257|-13.97|0.6726
73957539|NCT00383188|147451041|SUPERIORITY||Difference in percentage|-5.64|STANDARD_ERROR_OF_MEAN|7.68||0.4795|TWO_SIDED|90.0|-18.28|7.0|||Chi-squared|||Week 16||7.000|-18.28|0.4795
73957540|NCT00383188|147451041|SUPERIORITY||Difference in percentage|-16.17|STANDARD_ERROR_OF_MEAN|6.1||0.0276|TWO_SIDED|90.0|-26.19|-6.137|||Chi-squared|||Week 16||-6.137|-26.19|0.0276
73957541|NCT00383188|147451042|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
73957542|NCT00383188|147451042|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
73957543|NCT00383188|147451042|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
73957544|NCT00383188|147451042|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
73957545|NCT00383188|147451042|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 2||0.00|0.00|0.000
73957546|NCT00383188|147451042|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 2||0.00|0.00|0.000
73957547|NCT00383188|147451042|SUPERIORITY||Difference in percentage|2.27|STANDARD_ERROR_OF_MEAN|2.25||0.1928|TWO_SIDED|90.0|-1.423|5.968|||Chi-squared|||Week 2||5.968|-1.423|0.1928
73957548|NCT00383188|147451042|SUPERIORITY||Difference in percentage|2.5|STANDARD_ERROR_OF_MEAN|2.47||0.1719|TWO_SIDED|90.0|-1.56|6.56|||Chi-squared|||Week 2||6.560|-1.560|0.1719
73957549|NCT00383188|147451042|SUPERIORITY||Difference in percentage|0.1|STANDARD_ERROR_OF_MEAN|1.97||0.9603|TWO_SIDED|90.0|-3.138|3.334|||Chi-squared|||Week 4||3.334|-3.138|0.9603
73957550|NCT00383188|147451042|SUPERIORITY||Difference in percentage|-1.35|STANDARD_ERROR_OF_MEAN|1.34||0.3157|TWO_SIDED|90.0|-3.559|0.856|||Chi-squared|||Week 4||0.856|-3.559|0.3157
73957551|NCT00383188|147451042|SUPERIORITY||Difference in percentage|5.47|STANDARD_ERROR_OF_MEAN|4.03||0.1125|TWO_SIDED|90.0|-1.162|12.096|||Chi-squared|||Week 4||12.096|-1.162|0.1125
73957552|NCT00383188|147451042|SUPERIORITY||Difference in percentage|3.65|STANDARD_ERROR_OF_MEAN|3.7||0.2455|TWO_SIDED|90.0|-2.434|9.732|||Chi-squared|||Week 4||9.732|-2.434|0.2455
74091321|NCT00706381|147736549|SUPERIORITY||Percent change from placebo|125.7|STANDARD_DEVIATION|92.2|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
74091322|NCT01640873|147736602|OTHER||Least Squares Mean Difference|-8.5||||0.356|TWO_SIDED|90.0|-47.4|30.4||The posterior probability that the reduction in FPG is ≥ 20 mg/dL is 0.06, and hence, the FPG hypothesis was not met.|Constrained longitudinal data analysis|||||30.4|-47.4|0.356
74091323|NCT01640873|147736604|OTHER||Geometric Mean Ratio|1.05||||0.2714|TWO_SIDED|90.0|0.92|1.19||The posterior probability that the reduction in 24h-WMG is ≥ 20 mg/dL is \< 0.01, and hence, the 24h- WMG hypothesis was not met.|Constrained longitudinal data analysis|||||1.19|0.92|0.2714
74091324|NCT01640873|147736605|OTHER|Day 1|Geometric Mean Ratio|1.22||||0.06|TWO_SIDED|95.0|0.99|1.55|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.55|0.99|0.060
74091325|NCT01640873|147736605|OTHER|Day 3|Geometric mean Ratio|1.2||||0.065|TWO_SIDED|95.0|0.98|1.47|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.47|0.98|0.065
74091326|NCT01640873|147736605|OTHER|Day 16|Geometric Mean Ratio|1.1||||0.217|TWO_SIDED|95.0|0.89|1.37|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.37|0.89|0.217
74091327|NCT02749292|147736607|EQUIVALENCE|Using a two-sided log-rank test with an alpha level of 0.05, a projected relapse risk of 15% in the superior group and 30% in the inferior group, and an estimated enrollment time of 36 months, it was determined that 200 patients were required to detect a significant difference with a power of 0.80. Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.|Hazard Ratio (HR)|0.37||||0.045|TWO_SIDED|95.0|0.15|0.9|||Log Rank|||"The difference between the two treatment strategies was assessed using the log-rank test. P values of 0.05 were considered significant. Both rows were included and combined in the statistical analysis (ANCA-PR3 and ANCA-MPO) to assess the difference in treatment strategies.~Null hypothesis: No difference in the ANCA and B-cell arm in the probability of relapses."||0.90|0.15|0.045
74007288|NCT00578786|147564330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_DEVIATION|2.393|||TWO_SIDED|95.0|-0.69|-0.2|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.20|-0.69|
74007289|NCT00578786|147564331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_DEVIATION|2.603|||TWO_SIDED|95.0|-0.31|0.76|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.76|-0.31|
74007290|NCT00578786|147564331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33|STANDARD_DEVIATION|2.477|||TWO_SIDED|95.0|-0.68|0.03|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.03|-0.68|
74007291|NCT00578786|147564331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65|STANDARD_DEVIATION|2.305|||TWO_SIDED|95.0|-1.12|-0.18|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.18|-1.12|
74007292|NCT00578786|147564331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_DEVIATION|2.48|||TWO_SIDED|95.0|-0.52|-0.02|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.02|-0.52|
74007293|NCT00578786|147564332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|2.593|||TWO_SIDED|95.0|-0.33|0.74|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.74|-0.33|
74007294|NCT00578786|147564332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_DEVIATION|2.514|||TWO_SIDED|95.0|-0.51|0.22|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.22|-0.51|
74007295|NCT00578786|147564332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_DEVIATION|2.215|||TWO_SIDED|95.0|-0.93|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.03|-0.93|
74007296|NCT00578786|147564332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_DEVIATION|2.467|||TWO_SIDED|95.0|-0.39|0.11|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.11|-0.39|
74091328|NCT02749292|147736608|OTHER|chi square test||||||0.87|||||||Chi-squared|||"Null hypothesis: No difference in the proportion of patients with SAEs in each arm"||||0.87
74091329|NCT02749292|147736613|OTHER||||||<|1|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: no difference in the mean number of infusions per patient in each arm.||||<0001
74091330|NCT02749292|147736614|OTHER||Mean Difference (Final Values)|-0.14||||0.17|TWO_SIDED|95.0|-0.34|-0.06|||t-test, 2 sided|||Null hypothesis: there is no difference in the mean change from baseline Vasculitis Damage Index between each arm. A t-test was used.||-0.06|-0.34|0.17
74091331|NCT02749292|147736615|OTHER|Using a two-sided log-rank test with an alpha level of 0.05, a projected relapse risk of 15% in the superior group and 30% in the inferior group, and an estimated enrollment time of 36 months, it was determined that 200 patients were required to detect a significant difference with a power of 0.80. Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.|Hazard Ratio (HR)|1.64||||0.42|TWO_SIDED|95.0|0.5|5.36|||Log Rank|||"The difference between the two treatment strategies was assessed using the log-rank test. P values of 0.05 were considered significant.~Null hypothesis: No difference in the ANCA and B-cell arm in the probability of relapses"||5.36|0.50|0.42
74091332|NCT00251641|147736617|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|Pearson's chi-square test||The treatment comparison for this endpoint was carried at the 4.9% level of significance.||||<0.001
74091333|NCT00251641|147736618|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
74091334|NCT00251641|147736619|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
73878576|NCT02649556|147296751|OTHER||% Relative Reduction|3.11|||||TWO_SIDED|95.0|0.0231|6.1|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of sICAM-1 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|6.10|0.0231|
74091335|NCT00251641|147736620|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
74091336|NCT01244061|147736648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.08|||<|0.0001|TWO_SIDED|95.0|4.34|11.55||The statistical significance was declared for each hypothesis firstly for CAR Weeks 9-12, and then secondly for CAR Weeks 9-52 until a p-value \> 0.05 was obtained, at which point the hypothesis would be declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The study was conducted on a sample size to achieve at least 90% power for the treatment comparison in the primary efficacy endpoint assuming an odds ratio of 3.36 with a placebo abstinence rate of 12% and varenicline abstinence rate of 31%. The intent of the primary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment.||11.55|4.34|<0.0001
74091337|NCT01244061|147736649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|3.97|20.41||Statistical significance was declared for each hypothesis in the order above until a p-value \>0.05 was obtained, at which point the hypothesis was declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The sample size was sufficient to achieve 80% power for the treatment comparison in the key secondary end point for an odds ratio of 2.55 with a placebo abstinence rate of 6% and varenicline abstinence rate of 14%. The intent of the key secondary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation from Week 9 to the end of non-treatment follow up period at Week 52.||20.41|3.97|<0.0001
74091338|NCT01244061|147736650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.83|||<|0.0001|TWO_SIDED|95.0|3.25|10.44||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||||10.44|3.25|<0.0001
73957553|NCT00383188|147451042|SUPERIORITY||Difference in percentage|-2.6|STANDARD_ERROR_OF_MEAN|2.71||0.3452|TWO_SIDED|90.0|-7.057|1.847|||Chi-squared|||Week 8||1.847|-7.057|0.3452
73957554|NCT00383188|147451042|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|3.24||1|TWO_SIDED|90.0|-5.333|5.333|||Chi-squared|||Week 8||5.333|-5.333|1.0000
73957555|NCT00383188|147451042|SUPERIORITY||Difference in percentage|7.31|STANDARD_ERROR_OF_MEAN|5.31||0.1267|TWO_SIDED|90.0|-1.417|16.036|||Chi-squared|||Week 8||16.036|-1.417|0.1267
73957556|NCT00383188|147451042|SUPERIORITY||Difference in percentage|5.95|STANDARD_ERROR_OF_MEAN|5.27||0.2069|TWO_SIDED|90.0|-2.72|14.612|||Chi-squared|||Week 8||14.612|-2.720|0.2069
73957557|NCT00383188|147451042|SUPERIORITY||Difference in percentage|1.84|STANDARD_ERROR_OF_MEAN|4.08||0.6506|TWO_SIDED|90.0|-4.871|8.553|||Chi-squared|||Week 12||8.553|-4.871|0.6506
73957558|NCT00383188|147451042|SUPERIORITY||Difference in percentage|2.7|STANDARD_ERROR_OF_MEAN|4.12||0.5125|TWO_SIDED|90.0|-4.075|9.48|||Chi-squared|||Week 12||9.480|-4.075|0.5125
73957559|NCT00383188|147451042|SUPERIORITY||Difference in percentage|3.69|STANDARD_ERROR_OF_MEAN|5.07||0.4412|TWO_SIDED|90.0|-4.652|12.023|||Chi-squared|||Week 12||12.023|-4.652|0.4412
73957560|NCT00383188|147451042|SUPERIORITY||Difference in percentage|2.09|STANDARD_ERROR_OF_MEAN|4.92||0.6566|TWO_SIDED|90.0|-6.006|10.195|||Chi-squared|||Week 12||10.195|-6.006|0.6566
73957561|NCT00383188|147451042|SUPERIORITY||Difference in percentage|-5.16|STANDARD_ERROR_OF_MEAN|4.5||0.2634|TWO_SIDED|90.0|-12.57|2.247|||Chi-squared|||Week 16||2.247|-12.57|0.2634
73957562|NCT00383188|147451042|SUPERIORITY||Difference in percentage|-2.86|STANDARD_ERROR_OF_MEAN|4.73||0.546|TWO_SIDED|90.0|-10.63|4.916|||Chi-squared|||Week 16||4.916|-10.63|0.5460
73957563|NCT00383188|147451042|SUPERIORITY||Difference in percentage|-7.37|STANDARD_ERROR_OF_MEAN|4.43||0.1626|TWO_SIDED|90.0|-14.65|-0.086|||Chi-squared|||Week 16||-0.086|-14.65|0.1626
73957564|NCT00383188|147451042|SUPERIORITY||Difference in percentage|-7.37|STANDARD_ERROR_OF_MEAN|4.43||0.1626|TWO_SIDED|90.0|-14.65|-0.086|||Chi-squared|||Week 16||-0.086|-14.65|0.1626
73957565|NCT00383188|147451043|SUPERIORITY||Least Square Mean (LSM) Difference|-0.388|STANDARD_ERROR_OF_MEAN|1.025||0.7053|TWO_SIDED|95.0|-2.4|1.624|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.624|-2.400|0.7053
73957566|NCT00383188|147451043|SUPERIORITY||LSM Difference|-1.312|STANDARD_ERROR_OF_MEAN|1.009||0.1938|TWO_SIDED|95.0|-3.291|0.668|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.668|-3.291|0.1938
73957567|NCT00383188|147451043|SUPERIORITY||LSM Difference|-2.187|STANDARD_ERROR_OF_MEAN|1.174||0.0627|TWO_SIDED|95.0|-4.491|0.116|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.116|-4.491|0.0627
73957568|NCT00383188|147451043|SUPERIORITY||LSM Difference|-0.851|STANDARD_ERROR_OF_MEAN|1.206||0.4809|TWO_SIDED|95.0|-3.218|1.517|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.517|-3.218|0.4809
74038962|NCT02806947|147631168|SUPERIORITY|||||||0.078||||||Statistical significance was determine using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.078
74038963|NCT02806947|147631168|SUPERIORITY|||||||0.068||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 56 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.068
74038964|NCT02806947|147631169|SUPERIORITY|||||||0.785||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with overall survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.785
74038965|NCT02806947|147631170|SUPERIORITY|||||||0.34||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with disease-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.340
74038966|NCT02806947|147631171|SUPERIORITY|||||||0.713||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with event-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.713
74038967|NCT02806947|147631172|SUPERIORITY|||||||0.726||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with non-relapse mortality between the sirolimus and prednisone arms during the 12 month period post-randomization, with malignancy relapse treated as a competing risk for non-relapse mortality. These proportions were compared between treatment arms using Gray's test.||||0.726
74038968|NCT02806947|147631173|SUPERIORITY|||||||0.402||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with malignancy relapse between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for malignancy relapse. These proportions were compared between treatment arms using Gray's test.||||0.402
74038969|NCT02806947|147631174|SUPERIORITY|||||||0.296||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with chronic GVHD between the sirolimus and prednisone arms during the 12 month period post-randomization, with death and malignancy relapse treated as competing risks for chronic GVHD. These proportions were compared between treatment arms using Gray's test.||||0.296
74038970|NCT02806947|147631175|SUPERIORITY|||||||0.936||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.936
74038971|NCT02806947|147631175|SUPERIORITY|||||||0.598||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.598
74038972|NCT02806947|147631176|SUPERIORITY|||||||0.221||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with serious infections between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for serious infection. These proportions were compared between treatment arms using Gray's test.||||0.221
74038973|NCT00400712|147631202|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||ANCOVA|Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05||||||0.44
74038974|NCT00400712|147631203|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.83
74038975|NCT00400712|147631204|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANCOVA|||ANCOVA - comparing absolute measures and including baseline as co-variate||||0.45
74038976|NCT00400712|147631205|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANCOVA|adjusted for baseline values||||||0.72
74038977|NCT00400712|147631206|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANCOVA|controlled for baseline values||||||0.60
74038978|NCT00400712|147631207|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.66
74038979|NCT00400712|147631208|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.78
74038980|NCT02466412|147631209|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|63.9326|||||TWO_SIDED|95.0|49.6045|82.3991|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for Cmax. Therefore, there was no statistical hypothesis to be tested for this objective.||82.3991|49.6045|
74091339|NCT01244061|147736651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.85|||<|0.0001|TWO_SIDED|95.0|4.92|12.51||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 12 assessment||12.51|4.92|<0.0001
74038981|NCT02466412|147631210|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|60.0052|||||TWO_SIDED|95.0|44.9517|80.0997|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for AUC(0-last). Therefore, there was no statistical hypothesis to be tested for this objective.||80.0997|44.9517|
74038982|NCT02553317|147631211|SUPERIORITY||||||=|0.0099||||||The resulting p-value was compared with a significance level of 5%.|Log Rank|||Time to platelet count response in the caplacizumab arm and placebo arm was compared by conducting a two-sided stratified log-rank test based on a KM analysis, with severity of neurological involvement (according to the Glasgow coma scale \[GCS\] category, stratification factor used in randomization: ≤12 / 13-15) as stratification factor.||||= 0.0099
74038983|NCT02553317|147631211|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|1.095|2.195|||||The HR was estimated from a Cox proportional Hazards regression model.|Time to platelet count response was analyzed using a Cox proportional hazards regression model with time to platelet count response as dependent variable, and treatment group and GCS category as independent variables. The hazard (or platelet count normalization rate) ratio from the Cox model was reported along with 95% CI.||2.195|1.095|
74038984|NCT02553317|147631212|SUPERIORITY||||||<|0.0001||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was conducted with adjustment for GCS category (stratification factor used in randomization).||||< 0.0001
74038985|NCT02553317|147631213|SUPERIORITY||||||=|0.0004||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).||||= 0.0004
74038986|NCT02553317|147631214|SUPERIORITY||||||=|0.0572||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).||||= 0.0572
74038987|NCT03483116|147631220|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%.|Response rate|0.1553|||||TWO_SIDED|95.0|0.039|0.272||||||||0.272|0.039|
74038988|NCT03483116|147631220|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%|Response rate|0.001|||||TWO_SIDED|95.0|-0.115|0.117||||||||0.117|-0.115|
74038989|NCT03483116|147631220|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%|Difference Response rate|0.1543|||||TWO_SIDED|95.0|0.038|0.27||||||Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%||0.270|0.038|
74038990|NCT01181102|147631230|NON_INFERIORITY_OR_EQUIVALENCE|"(non-inferiority) When analyzed using the Z test at a one-sided 0.025 significance level, with the addition of a non-inferiority margin of 5% to the incidence in the enoxaparin group.~(superiority) The incidence of thromboembolic events for the FAS was compared using the χ2 test (two-sided significance level: 0.05)"|Cox Proportional Hazard|-6.5|||<|0.001|TWO_SIDED|95.0|-11.5|-1.6||non-inferiority:P \< 0.001 superiority:P = 0.010|non-inferiority:Z test. superiority:χ2 t|||The incidence proportion of thromboembolic events in the DU-176b group (P˅DU) = The incidence proportion of thromboembolic events in the enoxaparin group (P˅E) + Δ (5%). Alternative hypothesis H˅11: P˅DU \< P˅E + Δ (level of significance, 0.025; one-sided). If the null hypothesis H˅01 was rejected, the following analysis had to be sequentially performed using the χ2 test statistic. Null hypothesis H˅02: P˅DU = P˅E Alternative hypothesis H˅12: P˅DU ≠ P˅E (level of significance, 0.05; two-sided).||-1.6|-11.5|<0.001
74038991|NCT01181102|147631231|SUPERIORITY_OR_OTHER||χ2 test|2.5|||||TWO_SIDED|95.0|-0.8|5.9||||||||5.9|-0.8|
74038992|NCT01315002|147631232|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||Null hypothesis is that there was no difference in change of error percentage in the antisaccade task between nicotine and placebo. An ANOVA model was used with treatment (nicotine, placebo) as a within-subjects factor. The test was performed with a significance level of 0.05 (two-sided). Results showed significantly better antisaccade performance (i.e. less antisaccade errors) in the nicotine condition.||||<0.05
74038993|NCT05127421|147631290|SUPERIORITY||Odds Ratio (OR)|2.81||||0.091|TWO_SIDED|95.0|0.83|9.47|||Cochran-Mantel-Haenszel|stratified by the stratification factor (face and/or neck Investigator's Global Assessment \[IGA\] score of 2 or 3 at screening).||||9.47|0.83|0.091
74038994|NCT05127421|147631290|SUPERIORITY||response rate difference|19.5|STANDARD_ERROR_OF_MEAN|10.23|||TWO_SIDED|95.0|-0.5|39.6|||||The 95% confidence interval was computed based on a large-sample normal approximation with continuity correction.|||39.6|-0.5|
74038995|NCT02219087|147631297|SUPERIORITY_OR_OTHER|||||||0.137|||||||t-test, 2 sided|||||||0.137
74038996|NCT02219087|147631298|SUPERIORITY_OR_OTHER|||||||0.343|||||||t-test, 2 sided|||||||0.343
74038997|NCT02219087|147631299|SUPERIORITY_OR_OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
74038998|NCT02219087|147631300|SUPERIORITY_OR_OTHER|||||||0.385|||||||t-test, 2 sided|||||||0.385
74038999|NCT02219087|147631301|SUPERIORITY_OR_OTHER|||||||0.843|||||||Chi-squared|||||||0.843
74039000|NCT02219087|147631302|SUPERIORITY_OR_OTHER|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
74039001|NCT00094887|147631381|OTHER||||||=|0.8085|||||||Wilcoxon (Mann-Whitney)|||||||= 0.8085
74039002|NCT04111107|147631417|OTHER|||||||0.966|||||||Wilcoxon signed rank (2 sided)|||H0: Progression-free ratio = 1||||0.966
74039003|NCT04111107|147631420|OTHER|Single proportion was estimated.|proportion|4.2|||||TWO_SIDED|95.0|0.1|21.1|||||exact binomial confidence interval|The proportion with a complete or partial response was estimated and an exact binomial confidence interval was calculated||21.1|0.1|
74039004|NCT01714817|147631429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.7264|TWO_SIDED|95.0|0.7077|1.6421|||Stratified logistic regression||Abatacept IV:Placebo IV 95%CI for Odds Ratio|||1.6421|0.7077|0.7264
74039005|NCT01714817|147631430|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.4148|1.5956|||||Abatacept IV:Placebo IV|||1.5956|0.4148|
74039006|NCT01714817|147631431|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.17||||0.571|TWO_SIDED|95.0|-0.76|0.42|||Mixed Models Analysis||Adjusted mean difference from placebo|||0.42|-0.76|0.571
74039007|NCT01714817|147631432|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.09||||0.561|TWO_SIDED|95.0|-0.41|0.22|||Mixed Models Analysis||Adjusted mean difference from placebo|||0.22|-0.41|0.561
74039008|NCT01714817|147631435|SUPERIORITY||Estimate of Difference|1.651|||||TWO_SIDED|95.0|-7.595828|10.897784||||||CR - Day 365||10.897784|-7.595828|
74039009|NCT01714817|147631435|SUPERIORITY||Estimate of Difference|-0.8828|||||TWO_SIDED|95.0|-8.848056|7.082461||||||PR - Day 365||7.082461|-8.848056|
74039010|NCT01714817|147631435|SUPERIORITY||Estimate of Difference|-0.7682|||||TWO_SIDED|95.0|-10.446714|8.910353||||||NR - Day 365||8.910353|-10.446714|
74039011|NCT01714817|147631444|SUPERIORITY|Day 365|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.3251|6.2849||||||||6.2849|0.3251|
74039012|NCT01714817|147631444|SUPERIORITY|Day 729|Estimate of Difference vs Drug|3.4|||||TWO_SIDED|95.0|-8.4|15.1||||||||15.1|-8.4|
74039013|NCT01714817|147631464|SUPERIORITY||Estimate of Difference|-0.9682|||||TWO_SIDED|95.0|-4.760178|2.823876||||||Lupus treatment failure - Day 365||2.823876|-4.760178|
74039014|NCT01714817|147631464|SUPERIORITY||Estimate of Difference|-0.4707|||||TWO_SIDED|95.0|-4.588691|3.647365||||||Overall treatment failure - Day 365||3.647365|-4.588691|
74039015|NCT01714817|147631464|SUPERIORITY|Lupus treatment failure - Day 729|Estimate of Difference|0.8|||||TWO_SIDED|95.0|-4.5|6.1||||||||6.1|-4.5|
74039016|NCT01714817|147631464|SUPERIORITY|Overall treatment failure - Day 729|Estimate of Difference|2.7|||||TWO_SIDED|95.0|-3.3|8.8||||||||8.8|-3.3|
74039017|NCT02921763|147631474|SUPERIORITY||||||=|0.0533|||||||Sign test|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst, the values before treatment initiation and at last observation were compared, frequency of increase and decrease was summarized and the sign test was performed separately in the efficacy analysis set and study completers."||||=0.0533
74039018|NCT02921763|147631476|SUPERIORITY||||||=|0.7328|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.7328
74039019|NCT02921763|147631476|SUPERIORITY||||||=|0.1193|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.1193
74039020|NCT02921763|147631477|SUPERIORITY|||||||0.7221|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||0.7221
74039021|NCT02921763|147631477|SUPERIORITY|||||||0.0861|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||0.0861
74039022|NCT02921763|147631481|SUPERIORITY||||||=|0.002|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||=0.0020
74039023|NCT02921763|147631481|SUPERIORITY||||||=|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||=0.0001
74039024|NCT02921763|147631481|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
74039025|NCT02921763|147631481|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
74039026|NCT02921763|147631481|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
74039027|NCT02921763|147631482|SUPERIORITY||||||=|0.0024|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0024
74039028|NCT02921763|147631482|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
73957569|NCT00383188|147451043|SUPERIORITY||LSM Difference|-1.289|STANDARD_ERROR_OF_MEAN|1.017||0.2057|TWO_SIDED|95.0|-3.286|0.709|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.709|-3.286|0.2057
74039029|NCT02921763|147631482|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
74039030|NCT02921763|147631482|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
74039031|NCT02921763|147631482|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
74039032|NCT02921763|147631483|SUPERIORITY||||||=|0.0037|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0037
74039033|NCT02921763|147631483|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
74039034|NCT02921763|147631483|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
74039035|NCT02921763|147631483|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
74039036|NCT02921763|147631483|SUPERIORITY||||||=|0.0003|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0003
74039037|NCT02921763|147631484|SUPERIORITY||||||=|0.8035|||||||Wilcoxon (Mann-Whitney)|||"Separately in the efficacy analysis set and study completers, the values before treatment initiation and at last observation were compared, the value, difference from the value before treatment and change rate were calculated using the summary statistics, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.8035
74039038|NCT02921763|147631485|SUPERIORITY||||||=|0.8185|||||||Wilcoxon (Mann-Whitney)|||"Separately in the efficacy analysis set and study completers, the values before treatment initiation and at last observation were compared, the value, difference from the value before treatment and change rate were calculated using the summary statistics, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.8185
74039039|NCT02554253|147631520|SUPERIORITY|Pilot study||||||0.23|||||||Fisher Exact|||Raw scores converted to z-scores using published references. Percentage of patients experiencing a decline of \> 1 standard deviation was compared between groups using Fisher's exact test. The outcome of postoperative cognitive dysfunction (POCD) was defined a-priori as a decline of decline of \>1 standard deviation (i.e. z-score decline of \> 1) on at least 2 neurocognitive tests and was compared between groups using Fisher's exact test.||||0.23
74039040|NCT02554253|147631521|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
74039041|NCT02554253|147631522|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
74039042|NCT01998269|147631529|SUPERIORITY_OR_OTHER||correlation coefficient|0.6|||<|0.001|TWO_SIDED||||||Correlation||r= 0.60, p-value\<0.001. P values below 0.05 are considered statistically significant in this study.|We examined correlations between patient scores on the Measure of Medication Self-Management (MeDS) and the 8-item Morisky Medication Adherence questionnaire.||||<.001
74039043|NCT02559206|147631536|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|TWO_SIDED|95.0|-1.214|0.076|||mixed model repeated measures (MMRM)|||||0.076|-1.214|0.0839
74039044|NCT02559206|147631536|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.297||||0.3661|TWO_SIDED|95.0|-0.942|0.348|||MMRM|||||0.348|-0.942|0.3661
74039045|NCT02559206|147631536|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.286||||0.3869|TWO_SIDED|95.0|-0.936|0.363|||MMRM|||||0.363|-0.936|0.3869
74039046|NCT02559206|147631536|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.771||||0.0199|TWO_SIDED|95.0|-1.419|-0.123|||MMRM|||||-0.123|-1.419|0.0199
74039047|NCT02559206|147631536|SUPERIORITY|||||||0.0276||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.0276
74039048|NCT02559206|147631537|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|TWO_SIDED|95.0|-1.214|0.076|||MMRM|||||0.076|-1.214|0.0839
74039049|NCT02559206|147631537|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.455||||0.1669|TWO_SIDED|95.0|-1.102|0.191|||MMRM|||||0.191|-1.102|0.1669
74039050|NCT02559206|147631537|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.299||||0.3637|TWO_SIDED|95.0|-0.947|0.348|||MMRM|||||0.348|-0.947|0.3637
74039051|NCT02559206|147631537|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.258||||0.4333|TWO_SIDED|95.0|-0.905|0.389|||MMRM|||||0.389|-0.905|0.4333
74039052|NCT02559206|147631537|SUPERIORITY|||||||0.5528||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.5528
74039053|NCT02559206|147631538|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.992||||0.011|TWO_SIDED|95.0|0.228|1.756|||MMRM|||||1.756|0.228|0.0110
74007297|NCT04884763|147564372|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.567|TWO_SIDED|95.0|-0.76|1.35||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.35|-0.76|0.567
74007298|NCT04884763|147564373|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.778|TWO_SIDED|95.0|-0.91|1.21||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.21|-0.91|0.778
74039054|NCT02559206|147631538|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.048||||0.9013|TWO_SIDED|95.0|-0.716|0.812|||MMRM|||||0.812|-0.716|0.9013
74039055|NCT02559206|147631538|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.299||||0.4447|TWO_SIDED|95.0|-0.469|1.067|||MMRM|||||1.067|-0.469|0.4447
74039056|NCT02559206|147631538|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.662||||0.0904|TWO_SIDED|95.0|-0.104|1.428|||MMRM|||||1.428|-0.104|0.0904
74039057|NCT02559206|147631538|SUPERIORITY|||||||0.07||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.0700
74039058|NCT02559206|147631539|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.992||||0.011|TWO_SIDED|95.0|0.228|1.756|||MMRM|||||1.756|0.228|0.0110
74039059|NCT02559206|147631539|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.161||||0.6801|TWO_SIDED|95.0|-0.604|0.925|||MMRM|||||0.925|-0.604|0.6801
74039060|NCT02559206|147631539|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.095||||0.8069|TWO_SIDED|95.0|-0.861|0.67|||MMRM|||||0.670|-0.861|0.8069
74039061|NCT02559206|147631539|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.246||||0.5275|TWO_SIDED|95.0|-1.011|0.519|||MMRM|||||0.519|-1.011|0.5275
74039062|NCT02559206|147631539|SUPERIORITY|||||||0.4201||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.4201
74039063|NCT02559206|147631540|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1663|TWO_SIDED|95.0|0.79|3.7|||Cochran-Mantel-Haenszel|||||3.70|0.79|0.1663
74039064|NCT02559206|147631540|SUPERIORITY||Odds Ratio (OR)|1.39||||0.4399|TWO_SIDED|95.0|0.61|3.17|||Cochran-Mantel-Haenszel|||||3.17|0.61|0.4399
74039065|NCT02559206|147631540|SUPERIORITY||Odds Ratio (OR)|1.27||||0.554|TWO_SIDED|95.0|0.57|2.85|||Cochran-Mantel-Haenszel|||||2.85|0.57|0.5540
74039066|NCT02559206|147631540|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0262|TWO_SIDED|95.0|1.1|5.19|||Cochran-Mantel-Haenszel|||||5.19|1.10|0.0262
74039067|NCT02559206|147631540|SUPERIORITY|||||||0.0249||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test|||||||0.0249
74039068|NCT02559206|147631541|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1663|TWO_SIDED|95.0|0.79|3.7|||Cochran-Mantel-Haenszel|||||3.70|0.79|0.1663
74039069|NCT02559206|147631541|SUPERIORITY||Odds Ratio (OR)|1.13||||0.771|TWO_SIDED|95.0|0.49|2.58|||Cochran-Mantel-Haenszel|||||2.58|0.49|0.7710
74039070|NCT02559206|147631541|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8021|TWO_SIDED|95.0|0.48|2.58|||Cochran-Mantel-Haenszel|||||2.58|0.48|0.8021
74039071|NCT02559206|147631541|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8011|TWO_SIDED|95.0|0.37|2.14|||Cochran-Mantel-Haenszel|||||2.14|0.37|0.8011
74039072|NCT02559206|147631541|SUPERIORITY|||||||0.8578||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test|||||||0.8578
74039073|NCT01512108|147631570|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.27||||0.0026||95.0|-0.44|-0.09|||ANOVA|||||-0.09|-0.44|0.0026
74039074|NCT01512108|147631571|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.3||||0.0458||95.0|-0.6|-0.01|||ANOVA|||||-0.01|-0.60|0.0458
74039075|NCT02373371|147631572|SUPERIORITY|||||||0.846|||||||Wilcoxon (Mann-Whitney)|||"Main analysis:~* nbDPKAdispM3 the number of KA disappeared at M3 after treatment with DPDT compared to the inclusion layer,~* nbCPKAdispM3 the number of KA disappeared at M3 after treatment with conventional blue light,~The primary endpoint is:~differenceM3 = nbDPKAdispM3 - nbCPKAdispM3 The main analysis will consist of a signed Wilcoxon rank test for matched data testing whether difference M3 is significantly different from 0"||||0.8460
74039076|NCT02373371|147631574|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
74039077|NCT02373371|147631575|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
74039078|NCT02678312|147631667|SUPERIORITY||Cox Proportional Hazard|1.0655||||0.7958|TWO_SIDED|95.0|0.6589|1.7232||The adjusted hazard ratio and the p-values are based on a Cox proportional hazard model, stratified by modified age group with treatment and NYHA/ROSS class group included as factor.|Cox Proportional Hazard|||||1.7232|0.6589|0.7958
74039079|NCT03532776|147631727|EQUIVALENCE|BE limits: -20.0% to 20.0%|Equivalence ratio|0.98|||||TWO_SIDED|90.0|-12.0|7.0||||||||7|-12|
74039080|NCT04547998|147631760|SUPERIORITY|The difference in the proportion of responders (RECELL-Control) was tested for superiority of RECELL treatment (with a 10% superiority margin). For the null hypothesis to be rejected and super-superiority of RECELL to Control to be established, the lower limit of the 2-sided 95% CI of the difference in the proportion of responders (RECELL-Control) had to be greater than 10%.||||||0.012|||||||continuity-corrected method|Liu et al 2002||||||0.012
74039081|NCT04547998|147631761|SUPERIORITY||||||<|0.001||||||P-value based on Wilcoxon signed rank test at 2-sided 0.05 significance level. The Wilcoxon signed rank test was based on the following repigmentation categories: 0% to 25%, 26% to 50%, 51% to 79%, and 80% to 100%.|Wilcoxon (Mann-Whitney)|||||||<0.001
73878577|NCT02649556|147296752|OTHER||% Relative Reduction|3.44|||||TWO_SIDED|95.0|-8.74|14.3|||||Derived as 100 x (1-Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 11-DTXB2 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|14.3|-8.74|
73878578|NCT02649556|147296753|OTHER||% Relative Reduction|7.15|||||TWO_SIDED|95.0|-1.03|14.7|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 8-epi-PGF2α levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|14.7|-1.03|
73878579|NCT02649556|147296754|OTHER||% Relative Reduction|46.3|||||TWO_SIDED|95.0|36.2|54.8|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of Total NNAL levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|54.8|36.2|
73878580|NCT02649556|147296755|OTHER||% Relative Reduction|31.7|||||TWO_SIDED|95.0|23.3|39.1|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of COHb levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|39.1|23.3|
73878581|NCT01405768|147296764|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||.13
74039082|NCT04547998|147631762|SUPERIORITY|||||||1||||||2-sided (0.05 significance level), based on 19 participants with assessable color matching outcomes for both treatments|Wilcoxon (Mann-Whitney)|||||||1.000
74039083|NCT01668030|147631776|SUPERIORITY|||||||0.0853|||||||t-test, 2 sided|||||||.0853
74039084|NCT01522443|147631777|SUPERIORITY_OR_OTHER|||||||0.773|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) was stratified by the Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||||0.773
74039085|NCT01522443|147631778|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by baslined Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||||<0.001
74039086|NCT01522443|147631779|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.121|TWO_SIDED|95.0|0.44|1.1|||Log Rank|The Log-Rank Test was stratified by baseline Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||1.10|0.44|0.121
74039087|NCT01764256|147631783|EQUIVALENCE|Definition of equivalence: p\<0.05||||||0.44|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event (related or unrelated)||||0.44
74039088|NCT01764256|147631783|EQUIVALENCE|Definition of equivalence: p\<0.05||||||0.7446|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event: potentially related||||0.7446
74039089|NCT01764256|147631784|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||0.5694|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||0.5694
74039090|NCT01764256|147631784|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)||||1.0000
74039091|NCT01764256|147631784|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
74039092|NCT01764256|147631785|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||0.6004|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||0.6004
73878582|NCT01405768|147296766|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||.13
73878583|NCT01169103|147296802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7||95.0|||||t-test, 2 sided|||We assumed that mean decrease in visceral fat in our population would be 0.85\*standard deviation score (SDS). Therefore, 18 subjects in each group would be required in order for us to have an 81.7% chance of detecting a significant difference in the mean 6-month changes in visceral adiposity between the groups at a 5% significance level by rejecting the null hypothesis that there is no difference in change in visceral fat following administration of rhGH or placebo in obese adolescent girls.||||0.70
73878584|NCT01169103|147296802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||t-test, 2 sided|||Change in SAT p-value||||0.30
73878585|NCT01169103|147296803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.93
73878586|NCT01169103|147296804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||t-test, 2 sided|||Change in Total Cholesterol p-value||||0.03
73878587|NCT01169103|147296804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Change in Triglyceride p-value||||0.57
74039093|NCT01764256|147631785|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)||||1
74039094|NCT01764256|147631785|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.00
74039095|NCT01764256|147631786|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||1.0000
74039096|NCT01764256|147631786|EQUIVALENCE|Equivalence defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)||||1.0000
74039097|NCT01764256|147631786|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
74039098|NCT01764256|147631787|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||1.0000
74039099|NCT01764256|147631787|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)||||1.0000
74039100|NCT01764256|147631787|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
74039101|NCT03373110|147631794|OTHER|||||||0.973||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models fit via maximum likelihood to examine the effect of the interventions on daily steps. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction. We used separate models to assess the intervention effects across the 8-week intervention period as well as the complete 16-week follow-up period.|The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.973
74039102|NCT03373110|147631794|OTHER|||||||0.005||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||.005
74039103|NCT03373110|147631794|OTHER|||||||0.004||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||.004
74039104|NCT03373110|147631794|OTHER|||||||0.627||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.627
74039105|NCT03373110|147631794|OTHER|||||||0.359||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.359
74039106|NCT03373110|147631794|OTHER|||||||0.597||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.597
74039107|NCT01804036|147631816|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|||||||0.84
74039108|NCT01804036|147631817|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANCOVA|||||||0.11
74039109|NCT01804036|147631818|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
74039110|NCT01804036|147631819|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANCOVA|||||||0.08
74039111|NCT01804036|147631820|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANCOVA|||||||0.20
74039112|NCT01804036|147631821|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
74039113|NCT01804036|147631822|SUPERIORITY_OR_OTHER|||||||0.52|||||||ANCOVA|||||||0.52
74039114|NCT01804036|147631823|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANCOVA|||||||0.54
74039115|NCT01804036|147631824|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|||||||0.94
73878588|NCT01169103|147296804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||t-test, 2 sided|||Change in Low-density lipoprotein p-value||||0.062
73878589|NCT01169103|147296804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0396|||||||t-test, 2 sided|||Change in High-density lipoprotein p-value||||0.0396
74039116|NCT01804036|147631825|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
74039117|NCT01804036|147631826|SUPERIORITY_OR_OTHER|||||||0.49|||||||ANCOVA|||||||0.49
74039118|NCT01804036|147631827|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
74039119|NCT01804036|147631828|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
74039120|NCT01804036|147631829|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
74039121|NCT02940626|147631834|OTHER|||||||0.547|||||||Wald Test on equality of proportions|||Subjects were analyzed for efficacy in the group to which they randomized. Sponsor defined outcomes were based on review of microbiology results from samples tested at the central lab. If sample was not sent to the central lab., determination was based on results from the local microbiology lab. In cases where both local \& central lab results were available, concordance was confirmed for S. aureus. Therefore, the analysis used local microbiology data in order to utilize a more complete dataset.||||.5470
74039122|NCT03488914|147631856|SUPERIORITY||Slope|-1.09||||0.19|TWO_SIDED|95.0|-2.78|0.56|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 3-months||||.56|-2.78|.19
74039123|NCT03488914|147631856|SUPERIORITY||negative binomial regression|-1.66||||0.12|TWO_SIDED|95.0|-3.78|0.48|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 6-months||||.48|-3.78|.12
74039124|NCT03488914|147631856|SUPERIORITY||Slope|0.01||||0.99|TWO_SIDED|95.0|-2.05|2.07|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 9-months||||2.07|-2.05|.99
74039125|NCT03488914|147631856|SUPERIORITY||Slope|-0.78||||0.42|TWO_SIDED|95.0|-2.67|1.11|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 12-months||||1.11|-2.67|.42
74039126|NCT03488914|147631856|SUPERIORITY||Slope|-1.09||||0.18|TWO_SIDED|95.0|-2.69|0.51|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 15-months||||.51|-2.69|.18
74039127|NCT03488914|147631857|SUPERIORITY||Slope|0.03||||0.96|TWO_SIDED|95.0|-0.86|0.99|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 3-months||||.99|-.86|.96
74039128|NCT03488914|147631857|SUPERIORITY||Slope|-1.19||||0.03|TWO_SIDED|95.0|-2.25|-0.14|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 6-months||||-.14|-2.25|.03
74039129|NCT03488914|147631857|SUPERIORITY||Slope|0.13||||0.79|TWO_SIDED|95.0|-0.83|1.1|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 9-months||||1.10|-.83|.79
74039130|NCT03488914|147631857|SUPERIORITY||Slope|0.06||||0.91|TWO_SIDED|95.0|-0.99|1.11|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 12-months||||1.11|-.99|.91
74039131|NCT03488914|147631857|SUPERIORITY||Slope|-0.42||||0.44|TWO_SIDED|95.0|-1.5|0.65|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 15-months||||.65|-1.50|.44
74039132|NCT03488914|147631858|SUPERIORITY||Slope|-0.26||||0.54|TWO_SIDED|95.0|-1.09|0.58|||negative binomial regression|Model testing whether condition predicted marijuana use days at 3-months||||.58|-1.09|.54
74039133|NCT03488914|147631858|SUPERIORITY||Slope|0.38||||0.49|TWO_SIDED|95.0|-0.7|1.46|||negative binomial regression|Model testing whether condition predicted marijuana use days at 6-months||||1.46|-.70|.49
74039134|NCT03488914|147631858|SUPERIORITY||Slope|-0.26||||0.59|TWO_SIDED|95.0|-1.18|0.66|||negative binomial regression|Model testing whether condition predicted marijuana use days at 9-months||||.66|-1.18|.59
74039135|NCT03488914|147631858|SUPERIORITY||Slope|0.26||||0.65|TWO_SIDED|95.0|-0.86|1.37|||negative binomial regression|Model testing whether condition predicted marijuana use days at 12-months||||1.37|-.86|.65
74039136|NCT03488914|147631858|SUPERIORITY||Slope|-0.36||||0.49|TWO_SIDED|95.0|-1.4|0.67|||negative binomial regression|Model testing whether condition predicted marijuana use days at 15-months||||.67|-1.40|.49
74039137|NCT03488914|147631859|SUPERIORITY||Slope|-0.36||||0.31|TWO_SIDED|995.0|-1.07|0.34|||negative binomial regression|Model testing whether condition predicted alcohol use days at 3-months||||.34|-1.07|.31
74039138|NCT03488914|147631859|SUPERIORITY||Slope|-0.71||||0.1|TWO_SIDED|95.0|-1.57|0.15|||negative binomial regression|Model testing whether condition predicted alcohol use days at 6-months||||.15|-1.57|.10
74039139|NCT03488914|147631859|SUPERIORITY||Slope|-0.53||||0.2|TWO_SIDED|95.0|-1.34|0.28|||negative binomial regression|Model testing whether condition predicted alcohol use days at 9-months||||.28|-1.34|.20
74039140|NCT03488914|147631859|SUPERIORITY||Slope|-0.25||||0.58|TWO_SIDED|95.0|-1.14|0.64|||negative binomial regression|Model testing whether condition predicted alcohol use days at 12-months||||.64|-1.14|.58
74039141|NCT03488914|147631859|SUPERIORITY||Slope|-0.45||||0.34|TWO_SIDED|95.0|-1.37|0.47|||negative binomial regression|Model testing whether condition predicted alcohol use days at 15-months||||.47|-1.37|.34
74039142|NCT01802554|147631871|SUPERIORITY_OR_OTHER|||||||0.039|||||||Mixed Models Analysis|||||||.039
74039143|NCT01802554|147631872|SUPERIORITY_OR_OTHER|||||||0.701|||||||Mixed Models Analysis|||||||.701
74039144|NCT01802554|147631873|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
74039145|NCT01802554|147631874|SUPERIORITY_OR_OTHER|||||||0.268|||||||Mixed Models Analysis|||||||.268
74039146|NCT01802554|147631875|SUPERIORITY_OR_OTHER|||||||0.021|||||||Mixed Models Analysis|||||||.021
74039147|NCT01583452|147631900|SUPERIORITY_OR_OTHER|||||||0.665|TWO_SIDED||||||Kaplan-Meier survival analysis|||With a confidence interval of 95%, an alpha risk of 5% and a desired power of 80%; expecting a 24hrs difference between the intervention and the control group, we estimated 20 patients for each one of them.||||0.665
74039148|NCT01583452|147631901|SUPERIORITY_OR_OTHER|||||||0.094|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.094
74039149|NCT01583452|147631902|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.059
74039150|NCT01583452|147631903|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.830
74039151|NCT00880763|147632001|SUPERIORITY_OR_OTHER||Adjusted difference in percent|65.1|||<|0.001|TWO_SIDED|95.0|37.0|82.8|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||82.8|37.0|<0.001
73957570|NCT00383188|147451043|SUPERIORITY||LSM Difference|-1.331|STANDARD_ERROR_OF_MEAN|0.999||0.1833|TWO_SIDED|95.0|-3.293|0.631|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.631|-3.293|0.1833
73957571|NCT00383188|147451043|SUPERIORITY||LSM Difference|-2.748|STANDARD_ERROR_OF_MEAN|1.166||0.0187|TWO_SIDED|95.0|-5.037|-0.459|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.459|-5.037|0.0187
73957572|NCT00383188|147451043|SUPERIORITY||LSM Difference|-1.345|STANDARD_ERROR_OF_MEAN|1.197||0.2615|TWO_SIDED|95.0|-3.695|1.005|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.005|-3.695|0.2615
73957573|NCT00383188|147451043|SUPERIORITY||LSM Difference|-1.764|STANDARD_ERROR_OF_MEAN|1.017||0.0832|TWO_SIDED|95.0|-3.761|0.233|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.233|-3.761|0.0832
73957574|NCT00383188|147451043|SUPERIORITY||LSM Difference|-1.615|STANDARD_ERROR_OF_MEAN|0.999||0.1066|TWO_SIDED|95.0|-3.576|0.347|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.347|-3.576|0.1066
73957575|NCT00383188|147451043|SUPERIORITY||LSM Difference|-2.406|STANDARD_ERROR_OF_MEAN|1.166||0.0394|TWO_SIDED|95.0|-4.695|-0.118|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.118|-4.695|0.0394
73957576|NCT00383188|147451043|SUPERIORITY||LSM Difference|-1.355|STANDARD_ERROR_OF_MEAN|1.197||0.258|TWO_SIDED|95.0|-3.705|0.995|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.995|-3.705|0.2580
73957577|NCT00383188|147451043|SUPERIORITY||LSM Difference|-0.758|STANDARD_ERROR_OF_MEAN|1.017||0.456|TWO_SIDED|95.0|-2.754|1.238|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.238|-2.754|0.4560
73957578|NCT00383188|147451043|SUPERIORITY||LSM Difference|-2.021|STANDARD_ERROR_OF_MEAN|0.999||0.0434|TWO_SIDED|95.0|-3.982|-0.06|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.060|-3.982|0.0434
74007299|NCT04884763|147564374|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.105|TWO_SIDED|95.0|-0.2|1.96||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.96|-0.20|0.105
74007300|NCT04884763|147564375|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.163|TWO_SIDED|95.0|-7.6|42.7||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||42.7|-7.6|0.163
74007301|NCT04884763|147564376|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.91|TWO_SIDED|95.0|-1.13|1.01||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.01|-1.13|0.910
74007302|NCT04884763|147564377|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.972|TWO_SIDED|95.0|-0.83|0.8||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||0.80|-0.83|0.972
74007303|NCT04884763|147564378|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.037|TWO_SIDED|95.0|0.18|5.43||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||5.43|0.18|0.037
74007304|NCT04884763|147564379|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.885|TWO_SIDED|95.0|-3.95|3.43||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||3.43|-3.95|0.885
74007305|NCT04884763|147564380|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.474|TWO_SIDED|95.0|-0.87|1.81||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.81|-0.87|0.474
74007306|NCT04884763|147564381|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.822|TWO_SIDED|95.0|-1.94|1.56||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.56|-1.94|0.822
74007307|NCT04884763|147564382|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.455|TWO_SIDED|95.0|-0.88|1.91||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.91|-0.88|0.455
74039152|NCT00880763|147632001|SUPERIORITY_OR_OTHER||Adjusted difference in percent|74.5|||<|0.001|TWO_SIDED|95.0|47.6|89.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||89.0|47.6|<0.001
74091340|NCT01244061|147736651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.86|4.64||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 24 assessment||4.64|1.86|<0.0001
74091341|NCT01244061|147736651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.88|4.97||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 52 assessment||4.97|1.88|<0.0001
74091342|NCT01929031|147736664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.738|STANDARD_ERROR_OF_MEAN|4.058|<|0.0001|TWO_SIDED|95.0|33.767|49.708|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo|||49.708|33.767|<0.0001
74091343|NCT01929031|147736664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.467|STANDARD_ERROR_OF_MEAN|4.058|<|0.0001|TWO_SIDED|95.0|28.497|44.437|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine|||44.437|28.497|<0.0001
74091344|NCT01929031|147736664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.126|STANDARD_ERROR_OF_MEAN|2.868|<|0.0001|TWO_SIDED|95.0|6.493|17.759|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen|||17.759|6.493|<0.0001
74091345|NCT01929031|147736665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.525|STANDARD_ERROR_OF_MEAN|0.808|<|0.0001|TWO_SIDED|95.0|6.937|10.113|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo|||10.113|6.937|<0.0001
74007308|NCT04884763|147564383|SUPERIORITY||Mean Difference (Final Values)|7.1||||0.467|TWO_SIDED|95.0|-12.8|27.0||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||27.0|-12.8|0.467
74007309|NCT04884763|147564384|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.755|TWO_SIDED|95.0|-0.79|1.07||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.07|-0.79|0.755
74007310|NCT04884763|147564385|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.613|TWO_SIDED|95.0|-1.18|0.71||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||0.71|-1.18|0.613
74007311|NCT04884763|147564386|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.003|TWO_SIDED|95.0|0.94|4.22||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||4.22|0.94|0.003
74091346|NCT01929031|147736665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.972|STANDARD_ERROR_OF_MEAN|0.808|<|0.0001|TWO_SIDED|95.0|6.384|9.559|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine|||9.559|6.384|<0.0001
74091347|NCT01929031|147736665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.594|STANDARD_ERROR_OF_MEAN|0.571|<|0.0001|TWO_SIDED|95.0|2.472|4.716|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen|||4.716|2.472|<0.0001
74091348|NCT01929031|147736666|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo||||<0.0001
74091349|NCT01929031|147736666|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine||||<0.0001
74007312|NCT04884763|147564387|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.536|TWO_SIDED|95.0|-2.7|5.08||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||5.08|-2.70|0.536
74007313|NCT02178553|147564392|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.142|TWO_SIDED|90.0|-0.1|1.8|||t-test, 2 sided|||||1.8|-0.1|0.142
74007314|NCT02178553|147564393|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.101|TWO_SIDED|90.0|0.4|1.9|||t-test, 2 sided|||||1.9|0.4|0.101
74007315|NCT02178553|147564394|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.014|TWO_SIDED|90.0|0.4|1.9|||t-test, 2 sided|||||1.9|0.4|0.014
74007316|NCT02178553|147564395|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.375|TWO_SIDED|90.0|-0.3|1.0|||t-test, 2 sided|||||1.0|-0.3|0.375
74039153|NCT00880763|147632001|SUPERIORITY_OR_OTHER||Adjusted difference in percent|55.4|||<|0.001|TWO_SIDED|95.0|24.9|76.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||76.0|24.9|<0.001
73878590|NCT01169103|147296805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||t-test, 2 sided|||||||0.58
74007317|NCT00778622|147564404|SUPERIORITY_OR_OTHER|||||||0.0806||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HbA1c at Week 16 was dependent variable, BMI was fixed main effect, baseline HbA1c was covariate.||"Standard deviation assumed for changes from baseline in HbA1c maximally was 1.0 across the baseline BMI subgroups. 97 participants in a single subgroup would be sufficient to estimate mean change in HbA1c with precision of 0.20% within the subgroup. Given number of baseline BMI subgroups and no correction for reason of multiplicity was made to the 95% CI within each BMI subgroup, total sample size calculated as 291. Sample size used the method CI for mean for one group in nQuery Advisor v6.0."||||0.0806
74007318|NCT00778622|147564404|SUPERIORITY_OR_OTHER|||||||0.1984||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.1984
74007319|NCT00778622|147564404|SUPERIORITY_OR_OTHER|||||||0.0232||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.0232
74007320|NCT00778622|147564404|SUPERIORITY_OR_OTHER|||||||0.3589||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.3589
74007321|NCT00778622|147564405|SUPERIORITY_OR_OTHER|||||||0.4614||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in FPG at Week 16 was dependent variable, BMI was fixed main effect, baseline FPG was covariate.||||||0.4614
74007322|NCT00778622|147564405|SUPERIORITY_OR_OTHER|||||||0.4696||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.4696
74007323|NCT00778622|147564405|SUPERIORITY_OR_OTHER|||||||0.5305||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.5305
74007324|NCT00778622|147564405|SUPERIORITY_OR_OTHER|||||||0.9145||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.9145
74007325|NCT00778622|147564406|SUPERIORITY_OR_OTHER|||||||0.0305||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TC at Week 16 was dependent variable, BMI was fixed main effect, baseline TC was covariate.||||||0.0305
74007326|NCT00778622|147564406|SUPERIORITY_OR_OTHER|||||||0.008||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0080
74007327|NCT00778622|147564406|SUPERIORITY_OR_OTHER|||||||0.0422||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0422
74007328|NCT00778622|147564407|SUPERIORITY_OR_OTHER|||||||0.4508||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in LDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline LDL-C was covariate.||||||0.4508
74007329|NCT00778622|147564407|SUPERIORITY_OR_OTHER|||||||0.0526||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0526
74007330|NCT00778622|147564407|SUPERIORITY_OR_OTHER|||||||0.1295||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.1295
74007331|NCT00778622|147564408|SUPERIORITY_OR_OTHER|||||||0.1431||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline HDL-C was covariate.||||||0.1431
74007332|NCT00778622|147564408|SUPERIORITY_OR_OTHER|||||||0.4066||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.4066
74007333|NCT00778622|147564408|SUPERIORITY_OR_OTHER|||||||0.4071||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.4071
74007334|NCT00778622|147564409|SUPERIORITY_OR_OTHER|||||||0.021||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TG at Week 16 was dependent variable, BMI was fixed main effect, baseline TG was covariate.||||||0.0210
74007335|NCT00778622|147564409|SUPERIORITY_OR_OTHER|||||||0.2507||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.2507
74007336|NCT00778622|147564409|SUPERIORITY_OR_OTHER|||||||0.6546||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.6546
74007337|NCT02558231|147564447|SUPERIORITY||Ratio of geometric Least Square mean|0.96||||0.4239|TWO_SIDED|95.0|0.86|1.07|||ANCOVA|||||1.07|0.86|0.4239
74007338|NCT02558231|147564448|SUPERIORITY||Least Square (LS) Mean difference|-1.43||||0.8758|TWO_SIDED|95.0|-19.393|16.538|||ANCOVA|||||16.538|-19.393|0.8758
74007339|NCT02558231|147564449|SUPERIORITY||Ratio of geometric LS mean|1.03||||0.8529|TWO_SIDED|95.0|0.77|1.371|||ANCOVA|||||1.371|0.770|0.8529
74007340|NCT02558231|147564451|SUPERIORITY||LS Mean Difference|-0.72||||0.4998|TWO_SIDED|95.0|-2.834|1.386|||ANCOVA|||||1.386|-2.834|0.4998
74007341|NCT02558231|147564452|SUPERIORITY||LS Mean Difference|-0.09||||0.8528|TWO_SIDED|95.0|-1.003|0.83|||ANCOVA|||||0.830|-1.003|0.8528
74007342|NCT02558231|147564453|SUPERIORITY||LS Mean Difference|2.4||||0.9474|TWO_SIDED|95.0|-69.368|74.178|||ANCOVA|||||74.178|-69.368|0.9474
74007343|NCT02558231|147564454|SUPERIORITY||LS Mean Difference|0.13||||0.1902|TWO_SIDED|95.0|-0.066|0.328|||ANCOVA|||||0.328|-0.066|0.1902
74007344|NCT02558231|147564455|SUPERIORITY||LS Mean Difference|-1.2||||0.1227|TWO_SIDED|95.0|-2.737|0.327|||ANCOVA|||||0.327|-2.737|0.1227
73957579|NCT00383188|147451043|SUPERIORITY||LSM Difference|-1.728|STANDARD_ERROR_OF_MEAN|1.165||0.1386|TWO_SIDED|95.0|-4.016|0.56|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.560|-4.016|0.1386
73957580|NCT00383188|147451043|SUPERIORITY||LSM Difference|-1.154|STANDARD_ERROR_OF_MEAN|1.197||0.3353|TWO_SIDED|95.0|-3.503|1.196|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.196|-3.503|0.3353
73957581|NCT00383188|147451043|SUPERIORITY||LSM Difference|-2.08|STANDARD_ERROR_OF_MEAN|1.016||0.041|TWO_SIDED|95.0|-4.075|-0.085|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.085|-4.075|0.0410
73957582|NCT00383188|147451043|SUPERIORITY||LSM Difference|-2.234|STANDARD_ERROR_OF_MEAN|0.998||0.0255|TWO_SIDED|95.0|-4.194|-0.274|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.274|-4.194|0.0255
73957583|NCT00383188|147451043|SUPERIORITY||LSM Difference|-2.384|STANDARD_ERROR_OF_MEAN|1.165||0.041|TWO_SIDED|95.0|-4.671|-0.097|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.097|-4.671|0.0410
73957584|NCT00383188|147451043|SUPERIORITY||LSM Difference|-1.911|STANDARD_ERROR_OF_MEAN|1.196||0.1106|TWO_SIDED|95.0|-4.259|0.438|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.438|-4.259|0.1106
73957585|NCT00383188|147451043|SUPERIORITY||LSM Difference|-0.251|STANDARD_ERROR_OF_MEAN|1.048||0.8107|TWO_SIDED|95.0|-2.307|1.805|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.805|-2.307|0.8107
73957586|NCT00383188|147451043|SUPERIORITY||LSM Difference|0.272|STANDARD_ERROR_OF_MEAN|1.017||0.7895|TWO_SIDED|95.0|-1.726|2.269|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.269|-1.726|0.7895
73957587|NCT00383188|147451043|SUPERIORITY||LSM Difference|-0.306|STANDARD_ERROR_OF_MEAN|1.206||0.7996|TWO_SIDED|95.0|-2.673|2.06|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.060|-2.673|0.7996
73957588|NCT00383188|147451043|SUPERIORITY||LSM Difference|0.185|STANDARD_ERROR_OF_MEAN|1.235||0.8811|TWO_SIDED|95.0|-2.24|2.61|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.610|-2.240|0.8811
73957589|NCT00383188|147451044|SUPERIORITY||LSM Difference|-0.687|STANDARD_ERROR_OF_MEAN|0.886||0.4385|TWO_SIDED|95.0|-2.427|1.053|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.053|-2.427|0.4385
73957590|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.085|STANDARD_ERROR_OF_MEAN|0.87||0.2131|TWO_SIDED|95.0|-2.794|0.624|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.624|-2.794|0.2131
73957591|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.013||0.1216|TWO_SIDED|95.0|-3.559|0.419|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.419|-3.559|0.1216
73957592|NCT00383188|147451044|SUPERIORITY||LSM Difference|-0.675|STANDARD_ERROR_OF_MEAN|1.046||0.519|TWO_SIDED|95.0|-2.728|1.378|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.378|-2.728|0.5190
73957593|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.464|STANDARD_ERROR_OF_MEAN|0.88||0.0967|TWO_SIDED|95.0|-3.193|0.264|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.264|-3.193|0.0967
73957594|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.027|STANDARD_ERROR_OF_MEAN|0.863||0.2346|TWO_SIDED|95.0|-2.721|0.668|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.668|-2.721|0.2346
73957595|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.658|STANDARD_ERROR_OF_MEAN|1.007||0.1|TWO_SIDED|95.0|-3.635|0.318|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.318|-3.635|0.1000
73957596|NCT00383188|147451044|SUPERIORITY||LSM Difference|-0.805|STANDARD_ERROR_OF_MEAN|1.038||0.4385|TWO_SIDED|95.0|-2.844|1.234|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.234|-2.844|0.4385
74091350|NCT01929031|147736666|SUPERIORITY_OR_OTHER|||||||0.2389|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen||||0.2389
74091351|NCT01929031|147736667|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo||||<0.0001
74091352|NCT01929031|147736667|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine||||<0.0001
74091353|NCT01929031|147736667|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen||||0.0001
74091354|NCT00369382|147736672|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||two-sided alpha = 0.05|ANCOVA|Analysis of covariance (ANCOVA) with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.004
74091355|NCT00369382|147736674|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.018
74091356|NCT00369382|147736674|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<.001
73957597|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.599|STANDARD_ERROR_OF_MEAN|0.88||0.0696|TWO_SIDED|95.0|-3.327|0.128|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.128|-3.327|0.0696
74091357|NCT00369382|147736674|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.012
74091358|NCT00369382|147736674|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.072
74091359|NCT00369382|147736674|SUPERIORITY_OR_OTHER|||||||0.175|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.175
74091360|NCT00369382|147736675|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.031
74091361|NCT00369382|147736675|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<0.001
74091362|NCT00369382|147736675|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.020
74091363|NCT00369382|147736675|SUPERIORITY_OR_OTHER|||||||0.151|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.151
74091364|NCT00369382|147736675|SUPERIORITY_OR_OTHER|||||||0.295|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.295
74091365|NCT00369382|147736675|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.010
73878591|NCT01169103|147296806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0|||||t-test, 2 sided|||||||0.04
74091366|NCT00369382|147736677|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.009
74091367|NCT00369382|147736677|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<0.001
74091368|NCT00369382|147736677|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.002
74091369|NCT00369382|147736677|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.030
74091370|NCT00369382|147736677|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.121
74091371|NCT00369382|147736677|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.001
74091372|NCT00369382|147736679|SUPERIORITY_OR_OTHER||slope difference (CNI - SRL)|-2.311||||0.126|TWO_SIDED|95.0|-5.282|0.66||alpha is unadjusted|Random coefficient model||Random coefficient model with each participant's creatinine clearance function of time on treatment; intra-subject regression coefficients considered random.|||0.660|-5.282|0.126
74091373|NCT00369382|147736681|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED|||||alpha is unadjusted|Fisher Exact|||For-cause Biopsy-Confirmed Acute Rejection compared between treatment groups||||0.206
74091374|NCT00369382|147736681|SUPERIORITY_OR_OTHER|||||||0.476|TWO_SIDED|||||alpha is unadjusted|Fisher Exact|||Standard of Care Biopsy-Confirmed Acute Rejection compared between treatment groups||||0.476
74091375|NCT00609466|147736688|SUPERIORITY_OR_OTHER||Least square mean|70.8|||<|0.0001||95.0|35.9|105.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||105.6|35.9|<0.0001
74091376|NCT00609466|147736689|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Test for time (in hours) to first rescue medication use. No multiplicity adjustment.|Log Rank|Adjusted for site||||||<0.0001
74091377|NCT00609466|147736690|SUPERIORITY_OR_OTHER||Least square mean|37.5|||<|0.0001||95.0|22.7|52.2||No multiplicity adjustment used|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||52.2|22.7|<0.0001
74007345|NCT02558231|147564456|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0867|TWO_SIDED|95.0|0.32|1.09|||Log Rank|||||1.09|0.32|0.0867
74007346|NCT01006265|147564457|SUPERIORITY||Treatment effect (rate ratio)|0.226|||<|0.0001|TWO_SIDED|95.0|0.133|0.384|||Negative binomial regression model|||||0.384|0.133|<0.0001
74091378|NCT00609466|147736691|SUPERIORITY_OR_OTHER||Least square means|9.9|||<|0.0001||95.0|6.2|13.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||13.6|6.2|<0.0001
74091379|NCT00609466|147736692|SUPERIORITY_OR_OTHER||Least square mean|20.6|||<|0.0001||95.0|13.2|28.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||28.0|13.2|<0.0001
74091380|NCT00609466|147736693|SUPERIORITY_OR_OTHER||Least square mean|36.4|||<|0.0001||95.0|20.7|52.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||52.0|20.7|<0.0001
74007347|NCT01006265|147564457|SUPERIORITY||Treatment effect (rate ratio)|0.17|||<|0.0001|TWO_SIDED|95.0|0.1|0.289|||Negative binomial regression model|||||0.289|0.100|<0.0001
74091381|NCT00609466|147736694|SUPERIORITY_OR_OTHER||Least square means|108.2||||0.0002||95.0|51.9|164.5||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||164.5|51.9|0.0002
74091382|NCT03512262|147736695|SUPERIORITY||Least Squares (LSM) Means Difference|7.3165|||<|0.0001|TWO_SIDED|99.0|5.0668|9.5663||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||9.5663|5.0668|<0.0001
74091383|NCT03512262|147736696|SUPERIORITY||LSM Difference|2.1209|||<|0.0001|TWO_SIDED|99.0|0.9948|3.2469||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||3.2469|0.9948|<0.0001
74091384|NCT03512262|147736697|SUPERIORITY||LSM Difference|2.8221|||<|0.0001|TWO_SIDED|99.0|1.3972|4.2471||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||4.2471|1.3972|<0.0001
74091385|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.308|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2||||0.308
74091386|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.415|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2||||0.415
74091387|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.335|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3||||0.335
74091388|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2||||0.120
74007348|NCT01006265|147564457|SUPERIORITY||Treatment effect (rate ratio)|0.566||||0.0318|TWO_SIDED|95.0|0.337|0.952|||Negative binomial regression model|||||0.952|0.337|0.0318
74091389|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.061|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3||||0.061
74091390|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.031|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5||||0.031
74091391|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.131|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2||||0.131
74091392|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.202|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2||||0.202
74091393|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.484|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3||||0.484
74091394|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2||||0.047
74091395|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.285|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3||||0.285
74091396|NCT01195272|147736718|SUPERIORITY_OR_OTHER|||||||0.315|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5||||0.315
74091397|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.288|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2||||0.288
74091398|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.318|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2||||0.318
74091399|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3||||0.400
74091400|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.317|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2||||0.317
74091401|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.137|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3||||0.137
74091402|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.052|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5||||0.052
74091403|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.354|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2||||0.354
74091404|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.266|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2||||0.266
74007349|NCT04029961|147564481|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
74007350|NCT04029961|147564482|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
74007351|NCT04029961|147564483|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
74007352|NCT04029961|147564484|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
74007353|NCT04029961|147564485|OTHER|"A univariate analysis comparing the proportion of each arm that indicated an item was met, evaluated for each item at each time point."|||||<|0.05|||||||Univariate analysis|||"The statistical test described below was only performed on the top 10 items on the scale rated the highest in importance by participants. The top 10 items were determined by computing the mean rating for each item (participants gave each item a rating from '1' - '9' with higher values representing greater importance) and selecting the 10 items with the largest mean values, excluding the item the radiation oncologist who will be treating me as that item was not addressed in either intervention."||||<0.05
74007354|NCT03427125|147564486|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74007355|NCT03427125|147564487|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.0020
74007356|NCT05315947|147564569|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for Cmax was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.87|||||TWO_SIDED|90.0|0.7814|0.9686||||||||0.9686|0.7814|
74007357|NCT05315947|147564570|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for AUC(0-t) was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.989|||||TWO_SIDED|90.0|0.9756|1.003||||||||1.003|0.9756|
74007358|NCT04252287|147564576|SUPERIORITY||LS mean difference|4.3||||0.016|TWO_SIDED|95.0|0.8|7.8|||ANCOVA|||||7.8|0.8|0.016
74007359|NCT04252287|147564577|SUPERIORITY||LS mean difference|29.8||||0.852|TWO_SIDED|95.0|-284.4|344.1|||ANCOVA|||||344.1|-284.4|0.852
74008944|NCT01286454|147568262|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|48.58|||||TWO_SIDED|90.0|43.35|54.44||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||54.44|43.35|
74008945|NCT01286454|147568262|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|14.38|||||TWO_SIDED|90.0|12.83|16.11||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.||16.11|12.83|
74008946|NCT01286454|147568262|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|171.06|||||TWO_SIDED|90.0|115.82|187.78||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||187.78|115.82|
74008947|NCT00800683|147568265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|-0.89|-0.31|||ANCOVA|||For patients who received rescue medication during the course of the trial, the Oracle Clinical (OC) technique was utilised for all efficacy endpoints and the values were set to missing after the rescue medication was administered.||-0.31|-0.89|< 0.0001
74008948|NCT00800683|147568266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-1.03|-0.41|||ANCOVA|||||-0.41|-1.03|< 0.0001
74008949|NCT00800683|147568267|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.9|-0.33|||ANCOVA|||||-0.33|-0.90|< 0.0001
74008950|NCT00800683|147568268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.96|-0.41|||ANCOVA|||||-0.41|-0.96|< 0.0001
74008951|NCT00800683|147568269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.05|-0.39|||ANCOVA|||||-0.39|-1.05|< 0.0001
74008952|NCT00800683|147568270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-1.06|-0.44|||ANCOVA|||||-0.44|-1.06|< 0.0001
74008953|NCT00800683|147568271|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-0.96|-0.33|||ANCOVA|||||-0.33|-0.96|< 0.0001
74008954|NCT00800683|147568272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|-1.02|-0.44|||ANCOVA|||||-0.44|-1.02|< 0.0001
74008955|NCT00800683|147568273|SUPERIORITY_OR_OTHER|||||||0.1199||95.0||||P-value calculated using a Fisher's exact Test.|Fisher Exact|||||||0.1199
74008956|NCT00800683|147568274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.103||||0.2225||95.0|0.003|3.978|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance||3.978|0.003|0.2225
74008957|NCT00800683|147568275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.816||||0.8927|TWO_SIDED|95.0|0.042|15.756|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance||15.756|0.042|0.8927
74008958|NCT00800683|147568276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|11.43||0.8802||95.0|-24.36|20.91|||ANCOVA|||||20.91|-24.36|0.8802
74008959|NCT00800683|147568277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.24|STANDARD_ERROR_OF_MEAN|8.19||0.7848||95.0|-18.47|13.98|||ANCOVA|||||13.98|-18.47|0.7848
74008960|NCT00800683|147568278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|8.09||0.1878||95.0|-26.74|5.31|||ANCOVA|||||5.31|-26.74|0.1878
74008961|NCT00800683|147568279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.42|STANDARD_ERROR_OF_MEAN|7.92||0.5781||95.0|-11.28|20.12|||ANCOVA|||||20.12|-11.28|0.5781
74008962|NCT00800683|147568280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.24|STANDARD_ERROR_OF_MEAN|8.8||0.2954||95.0|-26.67|8.18|||ANCOVA|||||8.18|-26.67|0.2954
74008963|NCT00800683|147568281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.37|STANDARD_ERROR_OF_MEAN|8.27||0.5984||95.0|-12.02|20.75|||ANCOVA|||||20.75|-12.02|0.5984
74008964|NCT00800683|147568282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.07|STANDARD_ERROR_OF_MEAN|8.53||0.4085||95.0|-9.82|23.96|||ANCOVA|||||23.96|-9.82|0.4085
74008965|NCT00800683|147568283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|8.17||0.8698||95.0|-14.84|17.52|||ANCOVA|||||17.52|-14.84|0.8698
74008966|NCT01478360|147568286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166||||0.5392|TWO_SIDED|90.0|-0.617|0.285|||Mixed Models Analysis|||||0.285|-0.617|0.5392
74008967|NCT02289352|147568287|EQUIVALENCE|If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range \[-20%, +20%\], then bioequivalence of the Test product to the Reference product is considered to have been demonstrated.|Mean Difference (Net)|-0.58|||||TWO_SIDED|90.0|-6.49|5.33||||||||5.33|-6.49|
74008968|NCT02289352|147568287|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74008969|NCT02289352|147568287|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74008970|NCT02289352|147568288|EQUIVALENCE|"The secondary efficacy variable is the proportion of patients with a clinical response of treatment success on Day 1.~If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both the CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range \[-20%, 20%\], then bioequivalence of the Test to Reference product is considered to have been demonstrated."|Mean Difference (Net)|6.94|||||TWO_SIDED|90.0|-1.54|15.41||||||||15.41|-1.54|
74008971|NCT02289352|147568288|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74008972|NCT02289352|147568288|SUPERIORITY|||||||0.0045|||||||t-test, 2 sided|||||||0.0045
74008973|NCT00911625|147568289|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|9.502||0.958|TWO_SIDED|95.0|-19.341|18.341|||t-test, 2 sided|||The null hypothesis is that there is no difference between the two treatment cohorts on their average blood glucose level||18.341|-19.341|.958
74008974|NCT00911625|147568290|SUPERIORITY||Odds Ratio (OR)|0.438||||0.0828|TWO_SIDED|95.0|0.172|1.114|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of experiencing at least one blood glucose level below 70 mg/dL between the two treatment cohorts.||1.114|0.172|.0828
74008975|NCT01289821|147568291|SUPERIORITY_OR_OTHER||Percentage of Participants|43.9||||0.36|TWO_SIDED|80.0|33.19|55.09|||One-sample exact binomial test|||"Null hypothesis: True probability p of objective tumor response does not exceed p0, p0=0.4. H0: p\<=0.4 One-sided type I error probability of alpha=10%"||55.09|33.19|0.36
74008976|NCT03591354|147568297|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74008977|NCT02243865|147568464|SUPERIORITY|||||||0.6938|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||||||0.6938
74008978|NCT02243865|147568465|SUPERIORITY|||||||0.6557|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 1st month of the three month post treatment investigation duration||||0.6557
74008979|NCT02243865|147568465|SUPERIORITY|||||||0.515|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 2nd month of the three month post treatment investigation duration||||0.515
74008980|NCT02243865|147568465|SUPERIORITY|||||||0.3256|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 3rd month of the three month post treatment investigation duration||||0.3256
74008981|NCT02243865|147568465|SUPERIORITY|||||||0.4086|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the final four weeks of the three month post treatment investigation duration.||||0.4086
74008982|NCT04207801|147568480|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Efficacy of AUR101 was tested against placebo with respect to the primary endpoint (PASI75 response). A sample size of 25 in each of the three arms provided an 80% power with a one-sided Type I error of 0.05, if the true placebo response rate was 7% and the response rate on investigational arm(s) was 35%. The sample size was increased to 30 to account for \~ 15-20% dropouts over the study period.||||0.01
74008983|NCT01500525|147568483|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.0|||<|0.05|ONE_SIDED|95.0|||||Regression, Cox|||||||<0.05
74007360|NCT02273726|147564615|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% confidence interval (CI) for the treatment difference in least square (LS) means from MI ANCOVA model between the 2 treatment groups lay entirely above -0.75 g/dL.|LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.058|<|0.0001|TWO_SIDED|95.0|0.365|0.591|||ANCOVA|ANCOVA with MI||Treatment comparison was made using the multiple imputation (MI) strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb as a covariate, and treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and other randomization stratification factors except mean qualifying screening hemoglobin (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.591|0.365|<0.0001
74007361|NCT02273726|147564616|NON_INFERIORITY|The non-inferiority was established when the 2-sided 95% CI for the difference of LS means between the 2 treatment groups using the MMRM model lay entirely above -0.75 g/dL.|LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|0.404|0.687|||Mixed Models Analysis|||Treatment comparison was made using a mixed model of repeated measures (MMRM) with baseline Hb as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.687|0.404|<0.0001
74007362|NCT02273726|147564617|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|7.6|||||TWO_SIDED|95.0|0.9|14.3||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||14.3|0.9|
74007363|NCT02273726|147564618|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|2.7|||||TWO_SIDED|95.0|-4.3|9.7||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||9.7|-4.3|
74007364|NCT02273726|147564619|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|Least Square Mean Difference|-14.67|STANDARD_ERROR_OF_MEAN|1.514|<|0.0001|TWO_SIDED|95.0|-17.64|-11.695|||Mixed Models Analysis|||Treatment comparison was made using a MMRM with baseline as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||-11.695|-17.640|<0.0001
74007365|NCT02273726|147564620|NON_INFERIORITY|The non-inferiority margin was fixed as a difference of -0.75.|LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|0.503|0.869||Threshold for significance at 0.05 level.|ANCOVA|ANCOVA with MI||Treatment comparison was made using the MI strategy by combining the results of ANCOVA model with baseline Hb as a covariate, and treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and other randomization stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.869|0.503|<0.0001
74007366|NCT02273726|147564621|SUPERIORITY||LS Mean Difference|-20.14|STANDARD_ERROR_OF_MEAN|6.975||0.00091|TWO_SIDED|95.0|-33.842|-6.445||Threshold for significance at 0.05 level.|Rank ANCOVA|||Treatment comparison was made using an ANCOVA model with baseline iron repletion status, treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||-6.445|-33.842|0.00091
74007367|NCT02273726|147564622|NON_INFERIORITY|The non-inferiority margin for the difference between groups was 1.8.|Hazard Ratio (HR)|0.67||||0.0337|TWO_SIDED|95.0|0.466|0.97|||Cox Proportional Hazards model|||Analysis was done using a Cox Proportional Hazards model adjusting for baseline Hb and other stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.970|0.466|0.0337
74007368|NCT02273726|147564623|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.739||0.35|TWO_SIDED|95.0|-0.76|2.142|||Mixed Models Analysis|||Treatment comparison was made using MMRM with baseline as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||2.142|-0.760|0.3500
74007369|NCT03610165|147564626|SUPERIORITY||Median Difference (Final Values)|0.0||||0.757|TWO_SIDED|95.0|-0.03|0.04|||Wilcoxon (Mann-Whitney)|||||0.04|-0.03|0.757
74007370|NCT03610165|147564627|SUPERIORITY||Median Difference (Final Values)|-1.3||||0.715|TWO_SIDED|95.0|-12.0|7.0|||Wilcoxon (Mann-Whitney)|||||7|-12|0.715
74091405|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.378|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3||||0.378
74091406|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.422|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2||||0.422
74091407|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.444|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3||||0.444
74007371|NCT03610165|147564628|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.328|TWO_SIDED|95.0|-3.3|1.0|||Wilcoxon (Mann-Whitney)|||||1|-3.3|0.328
74007372|NCT03610165|147564629|SUPERIORITY||Median Difference (Final Values)|0.0||||0.376|TWO_SIDED|95.0|-0.001|0.011|||Wilcoxon (Mann-Whitney)|||||0.011|-0.001|0.376
74007373|NCT03610165|147564630|SUPERIORITY||Median Difference (Final Values)|0.0||||0.226|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.226
74007374|NCT03610165|147564631|SUPERIORITY||Median Difference (Final Values)|0.0||||0.61|TWO_SIDED|95.0|-0.67|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|-0.67|0.610
74007375|NCT03610165|147564632|SUPERIORITY||Median Difference (Final Values)|0.0||||0.302|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.302
74007376|NCT03610165|147564633|SUPERIORITY||Median Difference (Final Values)|0.0||||0.889|TWO_SIDED|95.0|-0.67|0.67|||Wilcoxon (Mann-Whitney)|||||0.67|-0.67|0.889
74007377|NCT03610165|147564634|SUPERIORITY||Median Difference (Final Values)|0.0||||0.403|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.403
74007378|NCT02877927|147564652|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|5.0|||||TWO_SIDED|95.0|-0.2|10.3|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||10.3|-0.2|
74007379|NCT02877927|147564653|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|3.3|||||TWO_SIDED|95.0|-2.2|8.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.9|-2.2|
74007380|NCT02877927|147564654|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.3|||||TWO_SIDED|95.0|-0.6|5.6|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||5.6|-0.6|
74007381|NCT00708175|147564657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.17|TWO_SIDED|95.0|-1.33|0.24||P-value is from a 1-way ANCOVA with treatment group as a factor and baseline BMD as a covariate. There were no multiplicity adjustments.|ANCOVA|||The sample size was calculated using a precision approach to estimate the difference between the pioglitazone and placebo treatment groups in the percent change from baseline in BMD.||0.24|-1.33|0.170
74007382|NCT00708175|147564658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.64|TWO_SIDED|95.0|-0.91|0.56||P-value is from a 1-way ANCOVA with treatment group as a factor and the Month 12 BMD value as a covariate. There were no multiplicity adjustments.|ANCOVA|||||0.56|-0.91|0.640
74007383|NCT01703663|147564675|SUPERIORITY_OR_OTHER||absolute difference|-5.73||||0.183|TWO_SIDED|95.0|-14.4|2.97|||ANOVA|||||2.97|-14.4|0.183
74007384|NCT00315939|147564695|SUPERIORITY_OR_OTHER||||||=|0.001|||||||ANOVA|||||||=0.001
74007385|NCT00789867|147564710|OTHER|||||||0.0002|||||||Kruskal-Wallis|||||||0.0002
74007386|NCT00789867|147564711|OTHER|||||||0.22|||||||Kruskal-Wallis|||||||0.22
74007387|NCT00789867|147564712|OTHER|||||||0.06|||||||Kruskal-Wallis|||||||0.06
74007388|NCT00789867|147564713|OTHER|||||||0.08|||||||Kruskal-Wallis|||||||0.08
74007389|NCT00789867|147564714|OTHER|||||||0.22|||||||Kruskal-Wallis|||||||0.22
74007390|NCT00789867|147564715|OTHER|||||||0.003|||||||Kruskal-Wallis|||||||0.003
74007391|NCT00594516|147564718|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of (-2, 2). A prespecified equivalence margin of (-2,2) was used for equivalence analysis.|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.09||||95.0|-0.09|0.28||||||Comparison of Tapentadol IR to ER analysis of variance model with factors for treatment, double blind cross-over period and subject.||0.28|-0.09|
74007392|NCT02462928|147564723|NON_INFERIORITY|For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.|Percentage Difference|-3.8|||||TWO_SIDED|95.1|-8.2|0.3|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||0.3|-8.2|
74007393|NCT02462928|147564723|NON_INFERIORITY|For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.|Percentage Difference|-4.2|||||TWO_SIDED|95.1|-8.7|0.0|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||0.0|-8.7|
74091408|NCT01195272|147736719|SUPERIORITY_OR_OTHER|||||||0.345|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5||||0.345
74091409|NCT01195272|147736720|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANOVA|||Visit 3 versus Visit 2||||0.39
74091410|NCT01195272|147736720|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||Visit 5 versus Visit 3||||0.08
74091411|NCT01195272|147736720|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3||||0.18
74091412|NCT01195272|147736721|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2||||0.48
74091413|NCT01195272|147736721|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||Visit 5 versus Visit 2||||0.30
74091414|NCT01195272|147736721|SUPERIORITY_OR_OTHER|||||||0.34|||||||ANOVA|||Visit 5 versus Visit 3||||0.34
74007394|NCT02462928|147564724|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares (LS) Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.1|-4.7|-0.1|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||-0.1|-4.7|
74007395|NCT02462928|147564724|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.1|-6.0|-1.3|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||-1.3|-6.0|
74007396|NCT02462928|147564725|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|8.6|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.1|-3.8|20.9|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||20.9|-3.8|
74091415|NCT01195272|147736722|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2||||0.22
74091416|NCT01195272|147736722|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 2||||0.44
74091417|NCT01195272|147736722|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANOVA|||Visit 5 versus Visit 3||||0.23
74091418|NCT01195272|147736723|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2||||0.22
74091419|NCT01195272|147736723|SUPERIORITY_OR_OTHER|||||||0.46|||||||ANOVA|||Visit 5 versus Visit 2||||0.46
74091420|NCT01195272|147736723|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||Visit 5 versus Visit 3||||0.24
73957598|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.863||0.0642|TWO_SIDED|95.0|-3.294|0.094|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.094|-3.294|0.0642
74091421|NCT01195272|147736724|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Visit 3 versus Visit 2||||0.05
74091422|NCT01195272|147736724|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|||Visit 5 versus Visit 2||||0.01
73957599|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.83|STANDARD_ERROR_OF_MEAN|1.007||0.0695|TWO_SIDED|95.0|-3.807|0.146|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.146|-3.807|0.0695
74007397|NCT02462928|147564725|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.1|-10.1|14.7|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||14.7|-10.1|
74091423|NCT01195272|147736724|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3||||0.18
74091424|NCT01195272|147736725|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2||||0.48
74091425|NCT01195272|147736725|SUPERIORITY_OR_OTHER|||||||0.43|||||||ANOVA|||Visit 5 versus Visit 2||||0.43
74091426|NCT01195272|147736725|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 3||||0.44
74091427|NCT01195272|147736726|SUPERIORITY_OR_OTHER|||||||0.313|||||||ANOVA|||Visit 3 versus Visit 2||||0.313
74091428|NCT01195272|147736726|SUPERIORITY_OR_OTHER|||||||0.083|||||||ANOVA|||Visit 5 versus Visit 2||||0.083
74091429|NCT01195272|147736726|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANOVA|||Visit 5 versus Visit 3||||0.092
74091430|NCT01195272|147736726|SUPERIORITY_OR_OTHER|||||||0.145|||||||ANOVA|||Visit 8 versus Visit 2||||0.145
74091431|NCT01195272|147736726|SUPERIORITY_OR_OTHER|||||||0.398|||||||ANOVA|||Visit 8 versus Visit 3||||0.398
74091432|NCT01195272|147736726|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANOVA|||Visit 8 versus Visit 5||||0.138
74091433|NCT01195272|147736727|SUPERIORITY_OR_OTHER|||||||0.467|||||||ANOVA|||Visit 3 versus Visit 2||||0.467
74091434|NCT01195272|147736727|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|||Visit 5 versus Visit 2||||0.250
74091435|NCT01195272|147736727|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||Visit 5 versus Visit 3||||0.060
74091436|NCT01195272|147736727|SUPERIORITY_OR_OTHER|||||||0.149|||||||ANOVA|||Visit 8 versus Visit 2||||0.149
74091437|NCT01195272|147736727|SUPERIORITY_OR_OTHER|||||||0.061|||||||ANOVA|||Visit 8 versus Visit 3||||0.061
74091438|NCT01195272|147736727|SUPERIORITY_OR_OTHER|||||||0.047|||||||ANOVA|||Visit 8 versus Visit 5||||0.047
74091439|NCT01195272|147736728|SUPERIORITY_OR_OTHER|||||||0.169|||||||ANOVA|||Visit 3 versus Visit 2||||0.169
74091440|NCT01195272|147736728|SUPERIORITY_OR_OTHER|||||||0.165|||||||ANOVA|||Visit 5 versus Visit 2||||0.165
74091441|NCT01195272|147736728|SUPERIORITY_OR_OTHER|||||||0.471|||||||ANOVA|||Visit 5 versus Visit 3||||0.471
74091442|NCT01195272|147736728|SUPERIORITY_OR_OTHER|||||||0.243|||||||ANOVA|||Visit 8 versus Visit 2||||0.243
74091443|NCT01195272|147736728|SUPERIORITY_OR_OTHER|||||||0.396|||||||ANOVA|||Visit 8 versus Visit 3||||0.396
74091444|NCT01195272|147736728|SUPERIORITY_OR_OTHER|||||||0.375|||||||ANOVA|||Visit 8 versus Visit 5||||0.375
74091445|NCT01195272|147736729|SUPERIORITY_OR_OTHER|||||||0.496|||||||ANOVA|||Visit 3 versus Visit 2||||0.496
74091446|NCT01195272|147736729|SUPERIORITY_OR_OTHER|||||||0.122|||||||ANOVA|||Visit 5 versus Visit 2||||0.122
74091447|NCT01195272|147736729|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANOVA|||Visit 5 versus Visit 3||||0.070
74091448|NCT01195272|147736729|SUPERIORITY_OR_OTHER|||||||0.135|||||||ANOVA|||Visit 8 versus Visit 2||||0.135
74091449|NCT01195272|147736729|SUPERIORITY_OR_OTHER|||||||0.082|||||||ANOVA|||Visit 8 versus Visit 3||||0.082
74091450|NCT01195272|147736729|SUPERIORITY_OR_OTHER|||||||0.461|||||||ANOVA|||Visit 8 versus Visit 5||||0.461
74091451|NCT04319718|147736741|OTHER|||||||0.025|||||||Fisher Exact|||||||.025
74091452|NCT04319718|147736742|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||.47
74007398|NCT02462928|147564726|SUPERIORITY||Percentage Difference|-4.7|||||TWO_SIDED|95.1|-11.5|2.1|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||2.1|-11.5|
74007399|NCT02462928|147564726|SUPERIORITY||Percentage Difference|-8.2|||||TWO_SIDED|95.1|-14.7|-1.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||-1.5|-14.7|
74007400|NCT02462928|147564727|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.1|-3.7|0.0|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||-0.0|-3.7|
74007401|NCT02462928|147564727|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.1|-2.7|1.0|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||1.0|-2.7|
74007402|NCT01493557|147564728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.31||||0.2554|TWO_SIDED|95.0|-6.54|29.49|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||29.49|-6.54|0.2554
74007403|NCT01493557|147564729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.3165|TWO_SIDED|95.0|-11.24|24.58|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||24.58|-11.24|0.3165
74007404|NCT01493557|147564730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.41||||0.0273|TWO_SIDED|95.0|0.71|35.98|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||35.98|0.71|0.0273
74007405|NCT01493557|147564731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52||||0.7104|TWO_SIDED|95.0|-44.22|28.4|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||28.40|-44.22|0.7104
74007406|NCT01493557|147564732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.81||||1|TWO_SIDED|95.0|-32.94|40.44|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||40.44|-32.94|1.0000
74007407|NCT01493557|147564733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.71||||1|TWO_SIDED|95.0|-41.25|28.77|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||28.77|-41.25|1.0000
74007408|NCT01493557|147564737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-9.9|8.9|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for the Duration of gastrointestinal symptoms (GIS).||8.9|-9.9|
74007409|NCT01493557|147564737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-3.5|6.3|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Complete effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.||6.3|-3.5|
74007410|NCT01493557|147564737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.2|||||TWO_SIDED|95.0|-8.2|48.5|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Partial effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.||48.5|-8.2|
74007411|NCT02656420|147564742|EQUIVALENCE|Statistical significance of the treatment effect (p \< 0.01) for the lower doses compared to the high dose as the reference.|Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.89|-1.57||Using a linear mixed effects model with random intercepts and slope, SF level (in the log scale) was regressed on categorical treatment group (medium dose and low dose; high as the reference) as well as day (continuous variable).|Mixed Models Analysis|||The null hypothesis is that the urinary sulforaphane levels are equal across treatment arms. Sulforaphane metabolite levels were measured daily for 10 days in each arm.||-1.57|-1.89|<0.001
74008984|NCT01159912|147568486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146||||0.009|TWO_SIDED|95.0|0.036|0.257|||ANCOVA|||||0.257|0.036|0.009
74091453|NCT04319718|147736746|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||.67
74091454|NCT04319718|147736747|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||.51
74091455|NCT04319718|147736748|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||.09
74091456|NCT04319718|147736749|OTHER|||||||0.65|||||||Mixed Models Analysis|||||||.65
74039154|NCT00880763|147632002|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.8|||||TWO_SIDED|95.0|-11.3|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-11.3|
74039155|NCT00880763|147632002|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.9|||||TWO_SIDED|95.0|-12.4|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-12.4|
74039156|NCT00880763|147632002|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.8|||||TWO_SIDED|95.0|-12.0|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-12.0|
74039157|NCT00880763|147632003|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.5|||||TWO_SIDED|95.0|-2.5|36.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.2|-2.5|
74039158|NCT00880763|147632003|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.6|||||TWO_SIDED|95.0|-3.4|36.3|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.3|-3.4|
74039159|NCT00880763|147632003|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.4|||||TWO_SIDED|95.0|-3.3|36.1|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.1|-3.3|
74039160|NCT00880763|147632004|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.8|||||TWO_SIDED|95.0|-2.3|-1.2|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.2|-2.3|
74039161|NCT00880763|147632004|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.9|||||TWO_SIDED|95.0|-2.4|-1.3|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.3|-2.4|
74039162|NCT00880763|147632004|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.6|||||TWO_SIDED|95.0|-2.2|-1.1|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.1|-2.2|
74039163|NCT01293006|147632011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|||||TWO_SIDED|90.0|-0.12|0.91|||Difference of Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||0.91|-0.12|
74091457|NCT04319718|147736749|OTHER|||||||0.24|||||||Mixed Models Analysis|||||||.24
74091458|NCT04319718|147736749|OTHER|||||||0.27|||||||Mixed Models Analysis|||||||.27
74091459|NCT04551911|147736776|OTHER|||||||0.7856|||||||Regression, Logistic|Logistic regression with treatment as the main effect, and baseline aggregate symptom score, baseline 25D level, and body weight as covariates||||||0.7856
74091460|NCT01030341|147736784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (\<50 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
74091461|NCT01030341|147736784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (\<70 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
74091462|NCT01030341|147736784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9||||||0.005||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of euglycemic excursions (70-180 mg/dL) during the screening phase and treatment phase respectively.||||0.005
74091463|NCT01030341|147736784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9||||||0.04||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (\>180 mg/dL) during the screening phase and treatment phase respectively.||||0.04
74039164|NCT01293006|147632014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||||TWO_SIDED|90.0|-1.3|3.36|||Difference of the Least Means Squares|||Day 1, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||3.36|-1.30|
74039165|NCT01293006|147632014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|90.0|-0.08|0.5|||Difference of the Least Squares Means|||Day 1, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.08|
74039166|NCT01293006|147632014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|90.0|-5.77|7.41|||Difference of the Least Squares Means|||Day 4, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||7.41|-5.77|
74039167|NCT01293006|147632014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|90.0|0.0|0.63|||Difference of the Least Squares Means|||Day 4, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.63|0.00|
74007412|NCT02656420|147564743|SUPERIORITY|To summarize first 12-hour SPMA levels over the study course by participant, the SPMA geometric mean (in the log scale) for each individual was calculated and used as the outcome. Treatment arms (placebo, fifth, half and full doses) were independent (categorical) variables in a linear regression model with placebo as the reference.|Mean Difference (Final Values)|63.2|||<|0.05|TWO_SIDED|95.0|10.6|140.9|||Regression, Linear||This Estimation Parameter was based on the comparison between the full dose group and the placebo group.|All broccoli sprout arms were compared with the placebo arm.||140.9|10.6|<0.05
74007413|NCT03662139|147564760|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
74039168|NCT01293006|147632015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|||||TWO_SIDED|90.0|-0.6|2.04|||Difference of the Least Squares Means|||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means||2.04|-0.60|
74039169|NCT01293006|147632015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|||||TWO_SIDED|90.0|0.33|3.77|||Difference of the Least Squares Means|||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means||3.77|0.33|
74039170|NCT01293006|147632016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|90.0|-0.41|0.47|||Difference in the Least Squares Means|||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.47|-0.41|
74039171|NCT01293006|147632016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|90.0|-0.53|0.27|||Difference of the Least Squares Means|||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.27|-0.53|
74039172|NCT01293006|147632016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||||TWO_SIDED|90.0|-0.61|0.18|||Difference of the Least Squares Means|||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.18|-0.61|
74039173|NCT01293006|147632016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.32|0.98|||Difference of the Least Squares Means|||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.98|-0.32|
74039174|NCT01293006|147632016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|90.0|-0.26|0.78|||Difference of the Least Squares Means|||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.78|-0.26|
74039175|NCT01293006|147632016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|||||TWO_SIDED|90.0|0.1|0.8|||Difference of the Least Squares Means|||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.80|0.10|
74039176|NCT01293006|147632017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.5|0.31|||Difference in the Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||0.31|-0.50|
74008985|NCT01159912|147568486|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.145||||0.011|TWO_SIDED|95.0|0.033|0.257|||ANCOVA|||||0.257|0.033|0.011
74008986|NCT02229539|147568519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Wilcoxon rank-sum|||||||0.02
74008987|NCT02229539|147568519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon rank-sum|||||||0.004
74039177|NCT01494987|147632018|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.71|-0.32||P-value is from a mixed-effect model including terms for baseline HbA1c value, prior antihyperglycemia therapy, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||-0.32|-0.71|<0.001
74008988|NCT04050670|147568530|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of AUC(0-∞) for the thigh versus abdomen injection sites were from 0.80 to 1.25|Ratio of geometric least squares mean|0.953|||||TWO_SIDED|90.0|0.935|0.97|||Linear mixed effects model|||||0.970|0.935|
74008989|NCT04050670|147568530|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of AUC(0-∞) for the upper arm versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.99|||||TWO_SIDED|90.0|0.972|1.01|||Linear mixed effects model|||||1.01|0.972|
74008990|NCT04050670|147568531|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of Cmax for thigh versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.862|||||TWO_SIDED|90.0|0.818|0.909|||Linear mixed effects model|||||0.909|0.818|
74008991|NCT04050670|147568531|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of Cmax for the upper arm versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.921|||||TWO_SIDED|95.0|0.874|0.971|||Linear mixed effects model|||||0.971|0.874|
74008992|NCT01480284|147568680|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was judged based on the one-sided test of the model, y(Δ) = Baseline + Group ( Δ= -1.0). The adjusted mean values of the TDF group and the ETV group were calculated, and the adjusted mean value and two-sided 95% confidence interval of differences between the TDF group and the ETV group were calculated. Non-inferiority was also to be confirmed when the upper limit of the calculated two-sided 95% confidence interval was less than the non-inferiority limit value of 1.0|Mean Difference (Final Values)|-0.13|||<|0.0001|TWO_SIDED|95.0|-0.28|0.02||p-value was compared with the significance level of 0.025|ANCOVA|||||0.02|-0.28|<0.0001
74008993|NCT01480284|147568681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.4|0.39|||||CI and estimate difference is provided for change from Baseline in serum HBV DNA level at Week 48.|||0.39|-0.40|
74039178|NCT03864536|147632032|SUPERIORITY||||||<|0.05||||||The statistical significance level was set using alpha of 0.05 without multiplicity correction. This pilot study was not powered for all the outcomes so the magnitude and estimates of intervention efficacy was of primary interest.|Mixed Models Analysis|||||||<0.05
74039179|NCT03864536|147632033|SUPERIORITY||||||<|0.05||||||The statistical significance level was set using alpha of 0.05 without multiplicity correction. This pilot study was not powered for all the outcomes so the magnitude and estimates of intervention efficacy was of primary interest.|Mixed Models Analysis|||||||<0.05
74039180|NCT04295356|147632034|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of Cmax was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|102.6|||||TWO_SIDED|90.0|94.08|111.9|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in Cmax between CT-P17 AI and CT-P17 PFS||111.90|94.08|
74091464|NCT01030341|147736784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (\>300 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
74091465|NCT01030341|147736785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 12 weeks of treatment.||||<0.0001
73957600|NCT00383188|147451044|SUPERIORITY||LSM Difference|-0.493|STANDARD_ERROR_OF_MEAN|1.038||0.6349|TWO_SIDED|95.0|-2.532|1.545|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.545|-2.532|0.6349
73957601|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.176|STANDARD_ERROR_OF_MEAN|0.88||0.1818|TWO_SIDED|95.0|-2.903|0.551|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.551|-2.903|0.1818
73957602|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.268|STANDARD_ERROR_OF_MEAN|0.862||0.1421|TWO_SIDED|95.0|-2.961|0.426|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.426|-2.961|0.1421
73957603|NCT00383188|147451044|SUPERIORITY||LSM Difference|-0.898|STANDARD_ERROR_OF_MEAN|1.006||0.3726|TWO_SIDED|95.0|-2.874|1.078|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.078|-2.874|0.3726
73957604|NCT00383188|147451044|SUPERIORITY||LSM Difference|-0.701|STANDARD_ERROR_OF_MEAN|1.038||0.4995|TWO_SIDED|95.0|-2.739|1.337|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.337|-2.739|0.4995
73957605|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.601|STANDARD_ERROR_OF_MEAN|0.879||0.0691|TWO_SIDED|95.0|-3.327|0.126|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.126|-3.327|0.0691
73957606|NCT00383188|147451044|SUPERIORITY||LSM Difference|-1.086|STANDARD_ERROR_OF_MEAN|0.862||0.2083|TWO_SIDED|95.0|-2.778|0.607|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.607|-2.778|0.2083
73957607|NCT00383188|147451044|SUPERIORITY||LSM Difference|-0.836|STANDARD_ERROR_OF_MEAN|1.006||0.4063|TWO_SIDED|95.0|-2.811|1.139|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.139|-2.811|0.4063
73957608|NCT00383188|147451044|SUPERIORITY||LSM Difference|-0.196|STANDARD_ERROR_OF_MEAN|1.038||0.8501|TWO_SIDED|95.0|-2.234|1.841|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.841|-2.234|0.8501
73957609|NCT00383188|147451044|SUPERIORITY||LSM Difference|0.376|STANDARD_ERROR_OF_MEAN|0.904||0.6778|TWO_SIDED|95.0|-1.399|2.15|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.150|-1.399|0.6778
73957610|NCT00383188|147451044|SUPERIORITY||LSM Difference|0.508|STANDARD_ERROR_OF_MEAN|0.877||0.5627|TWO_SIDED|95.0|-1.214|2.23|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.230|-1.214|0.5627
73957611|NCT00383188|147451044|SUPERIORITY||LSM Difference|0.537|STANDARD_ERROR_OF_MEAN|1.038||0.6049|TWO_SIDED|95.0|-1.501|2.576|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.576|-1.501|0.6049
73957612|NCT00383188|147451044|SUPERIORITY||LSM Difference|0.51|STANDARD_ERROR_OF_MEAN|1.068||0.6332|TWO_SIDED|95.0|-1.587|2.608|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.608|-1.587|0.6332
73957613|NCT00383188|147451045|SUPERIORITY||LSM Difference|-2.802|STANDARD_ERROR_OF_MEAN|4.098||0.4943|TWO_SIDED|95.0|-10.85|5.243|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||5.243|-10.85|0.4943
73957614|NCT00383188|147451045|SUPERIORITY||LSM Difference|-10.19|STANDARD_ERROR_OF_MEAN|4.026||0.0116|TWO_SIDED|95.0|-18.09|-2.283|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.283|-18.09|0.0116
74039181|NCT04295356|147632035|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of AUC0-inf was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|103.64|||||TWO_SIDED|90.0|93.98|114.29|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in AUC0-inf between CT-P17 AI and CT-P17 PFS||114.29|93.98|
73957615|NCT00383188|147451045|SUPERIORITY||LSM Difference|-12.73|STANDARD_ERROR_OF_MEAN|4.71||0.007|TWO_SIDED|95.0|-21.98|-3.485|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-3.485|-21.98|0.0070
73957616|NCT00383188|147451045|SUPERIORITY||LSM Difference|-11.14|STANDARD_ERROR_OF_MEAN|4.812||0.0209|TWO_SIDED|95.0|-20.58|-1.688|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-1.688|-20.58|0.0209
73957617|NCT00383188|147451045|SUPERIORITY||LSM Difference|-7.439|STANDARD_ERROR_OF_MEAN|4.056||0.0671|TWO_SIDED|95.0|-15.4|0.524|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||0.524|-15.40|0.0671
73957618|NCT00383188|147451045|SUPERIORITY||LSM Difference|-10.46|STANDARD_ERROR_OF_MEAN|3.986||0.0089|TWO_SIDED|95.0|-18.28|-2.632|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.632|-18.28|0.0089
73957619|NCT00383188|147451045|SUPERIORITY||LSM Difference|-14.1|STANDARD_ERROR_OF_MEAN|4.657||0.0025|TWO_SIDED|95.0|-23.24|-4.959|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-4.959|-23.24|0.0025
73957620|NCT00383188|147451045|SUPERIORITY||LSM Difference|-7.876|STANDARD_ERROR_OF_MEAN|4.774||0.0994|TWO_SIDED|95.0|-17.25|1.496|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.496|-17.25|0.0994
73957621|NCT00383188|147451045|SUPERIORITY||LSM Difference|-1.964|STANDARD_ERROR_OF_MEAN|4.056||0.6284|TWO_SIDED|95.0|-9.926|5.999|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||5.999|-9.926|0.6284
73957622|NCT00383188|147451045|SUPERIORITY||LSM Difference|-9.934|STANDARD_ERROR_OF_MEAN|3.986||0.0129|TWO_SIDED|95.0|-17.76|-2.109|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.109|-17.76|0.0129
73957623|NCT00383188|147451045|SUPERIORITY||LSM Difference|-8.097|STANDARD_ERROR_OF_MEAN|4.656||0.0825|TWO_SIDED|95.0|-17.24|1.044|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.044|-17.24|0.0825
73957624|NCT00383188|147451045|SUPERIORITY||LSM Difference|-1.907|STANDARD_ERROR_OF_MEAN|4.774||0.6897|TWO_SIDED|95.0|-11.28|7.465|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||7.465|-11.28|0.6897
73957625|NCT00383188|147451045|SUPERIORITY||LSM Difference|1.861|STANDARD_ERROR_OF_MEAN|4.055||0.6465|TWO_SIDED|95.0|-6.1|9.821|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||9.821|-6.100|0.6465
73957626|NCT00383188|147451045|SUPERIORITY||LSM Difference|-10.65|STANDARD_ERROR_OF_MEAN|3.985||0.0077|TWO_SIDED|95.0|-18.47|-2.824|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.824|-18.47|0.0077
73957627|NCT00383188|147451045|SUPERIORITY||LSM Difference|-7.927|STANDARD_ERROR_OF_MEAN|4.655||0.089|TWO_SIDED|95.0|-17.07|1.213|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.213|-17.07|0.0890
73957628|NCT00383188|147451045|SUPERIORITY||LSM Difference|-5.964|STANDARD_ERROR_OF_MEAN|4.773||0.2119|TWO_SIDED|95.0|-15.33|3.406|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||3.406|-15.33|0.2119
74091466|NCT01030341|147736785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 24 weeks of treatment.||||<0.0001
74091467|NCT01030341|147736785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 12 weeks of treatment.||||<0.0001
74091468|NCT01030341|147736785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 24 weeks of treatment.||||<0.0001
74007414|NCT03662139|147564760|SUPERIORITY||ICC|0.97|||<|0.05|TWO_SIDED|95.0|0.915|0.99|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: \>0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; \<0.50=low|Test - Retest Reliability (Difference between 1st and 2nd assessments in Cerebral Palsy group)||0.99|0.915|<0.05
74007415|NCT03662139|147564760|SUPERIORITY||ICC|0.983|||<|0.01|TWO_SIDED|95.0|0.882|0.998|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: \>0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; \<0.50=low|Interrater Reliability (Difference between 1st and 2nd evaluators in Cerebral Palsy group)||0.998|0.882|<0.01
74007416|NCT03662139|147564761|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
74007417|NCT03662139|147564761|SUPERIORITY||Spearman's correlation coefficient (rs)|0.724|||<|0.05|TWO_SIDED||||||Spearman's Correlation Test|The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.||Correlation between Dynamic Gait Index (DGI) and Pediatric Balance Scale (PBS) scores in Cerebral Palsy group||||<0.05
74007418|NCT03662139|147564762|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
74007419|NCT03662139|147564762|SUPERIORITY||Spearman's correlation coefficient (rs)|-0.828|||<|0.01|TWO_SIDED||||||Spearman's Correlation Test||The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Timed Up and Go Test (TUG) scores in Cerebral Palsy group||||<0.01
74007420|NCT03662139|147564763|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
74007421|NCT03662139|147564763|SUPERIORITY||Spearman's correlation coefficient (rs)|-0.673|||<|0.05|TWO_SIDED||||||Spearman's Correlation Test||The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Four Square Step Test (FSST) scores in Cerebral Palsy group.||||<0.05
74039182|NCT04295356|147632036|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of AUC0-last was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|105.36|||||TWO_SIDED|90.0|91.09|121.86|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in AUC0-last between CT-P17 AI and CT-P17 PFS||121.86|91.09|
74039183|NCT01106391|147632045|SUPERIORITY_OR_OTHER_LEGACY||Rate of technical success (%)|90.0|||||TWO_SIDED|95.0|79.5|96.2|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.||96.2|79.5|
74091469|NCT01030341|147736785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 12 weeks of treatment.||||<0.0001
74091470|NCT01030341|147736785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 24 weeks of treatment.||||<0.0001
74007422|NCT00702845|147564789|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margins of -3 and +5 were applied for the difference in the mean number of oocytes between the treatment groups. Org 36286 treatment was considered equivalent to the reference treatment (recFSH) if the two-sided 95% confidence interval of the difference was between -3 and +5 oocytes.|Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED|95.0|1.2|3.9|||ANOVA|||||3.9|1.2|<0.001
74007423|NCT02973425|147564811|OTHER||Cox Proportional Hazard|1.68||||0.02|TWO_SIDED|95.0|1.09|2.6|||Regression, Cox|||The primary hypothesis was tested through a time-to-event analysis implemented using Cox proportional hazards models||2.60|1.09|0.02
74007424|NCT02973425|147564812|OTHER||Linear regression|0.03||||0.03|TWO_SIDED|95.0|||||Regression, Linear|||For hypothesis 3, we compared the mean score on the SEQ-12 and its subscales at 6 months, adjusting for baseline.||||0.03
74007425|NCT02973425|147564813|OTHER|Six-month OR, 95%CI, and P value were calculated from generalized estimating equation marginal models with a logit link and an exchangeable correlation matrix.|Odds Ratio (OR)|1.92||||0.048|TWO_SIDED|95.0|1.01|3.68||Analysis models were adjusted by study site, having quit attempts in the past 12 months measured at baseline, cigarettes per day measured at baseline, quit attempts in the past 12 months measured at baseline.|Chi-squared|||||3.68|1.01|0.048
74007426|NCT02973425|147564814|OTHER||Odds Ratio (OR)|2.01||||0.01|TWO_SIDED|95.0|||||Regression, Linear|||During the first 3 weeks from randomization, both the Take a Break and comparison groups reported the number of cigarettes smoked daily (by texting); texting response rate (responded on at least 1 day).||||0.01
74007427|NCT03503513|147564832|SUPERIORITY||Risk Ratio (RR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.03|0.2|||differences in incidence rate ratio|An incidence rate ratio per person/month was determined by comparing the total number of UTIs in relation to time points.||comparison between pre and during treatment rates of UTI||0.20|0.03|<0.0001
74007428|NCT03503513|147564833|SUPERIORITY||Mean Difference (Final Values)|-3.8|STANDARD_DEVIATION|6.13|<|0.06|TWO_SIDED|95.0|-7.9|0.3||a priori threshold p value of \<0.05|t-test, 2 sided||Baseline to end of 6 month treatment score comparisons; (higher numbers represent more symptoms or complications)|NBSS Domain score for incontinence pre-post comparison; small sample size did not allow for power calculation.||0.3|-7.9|<0.06
74039184|NCT01106391|147632046|SUPERIORITY_OR_OTHER_LEGACY||Rate of achieved primary safety(%)|97.0|||||TWO_SIDED|95.0|88.1|99.6|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.||99.6|88.1|
74091471|NCT04280705|147736820|SUPERIORITY||Cox Proportional Hazard|1.29|||<|0.001|TWO_SIDED|95.0|1.12|1.49|||Log Rank|||||1.49|1.12|<0.001
74091472|NCT04280705|147736844|SUPERIORITY|||||||0.058|||||||Barnard's Exact Test|||||||0.058
74091473|NCT04280705|147736845|SUPERIORITY|||||||0.01|||||||Barnard's Exact Test|||||||0.010
74007429|NCT03503513|147564833|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|4.09|<|0.39|TWO_SIDED|95.0|-3.8|1.7||a priori threshold p\<0.05|t-test, 2 sided||(higher numbers represent more symptoms or complications)|NBSS Domain score for storage and voiding; pre-post comparison. Due to small sample size (n=11) no power calculations were conducted.||1.7|-3.8|<0.39
74007430|NCT03503513|147564833|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|3.99|<|0.14|TWO_SIDED|95.0|-4.6|0.8|||t-test, 2 sided||Higher numbers represent more symptoms or complications referred as consequences.|Pre and post test comparisons of mean NBSS scores for the consequences domain. Power calculations were not conducted due to small sample size.||0.8|-4.6|<0.14
74007431|NCT03503513|147564834|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|6.99|<|0.34|TWO_SIDED|95.0|-6.8|2.6|||t-test, 2 sided|||||2.6|-6.8|<0.34
74007432|NCT01681810|147564860|OTHER|Paired t-test comparing insulin stimulated glucose disposal at end of 12 weeks on nitrite drug to baseline (pre-drug) insulin stimulated glucose disposal.||||||0.2068|||||||t-test, 2 sided|||||||0.2068
74007433|NCT01681810|147564861|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.||||||0.0074||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||0.0074
74007434|NCT01681810|147564862|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||<0.0001
74007435|NCT01681810|147564863|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||<0.0001
74007436|NCT01681810|147564864|OTHER|One-way repeated measures ANOVA comparing methemoglobin percent over time on nitrite drug to baseline (pre-drug) methemoglobin percent.||||||0.0127||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||0.0127
74039185|NCT04426890|147632055|EQUIVALENCE|Therapeutic equivalence was declared if the two-sided 90% confidence interval (CI) for the treatment difference was entirely within an equivalence margin of \[-2.5, 2.0\].|Mean Difference (Net)|0.7|||||TWO_SIDED|90.0|-0.22|1.63||||||The statistical analysis of mean change from baseline in ISS7 at Week 12 between CT-P39 300 mg treatment arm (Arm 1) and Xolair 300 mg treatment arm (Arm 2), using ANCOVA with multiple imputation based on the MAR assumption was performed for the mITT Set.||1.63|-0.22|
74039186|NCT04268004|147632078|OTHER|Chi-squared test was used to determine if study arm is associated with FP uptake.|||||=|0.64|||||||Chi-squared|df=(1, 19)||Chi-square test was used to determine if study arm is associated with FP uptake.||||=.64
74039187|NCT03783442|147632083|SUPERIORITY||Stratified Hazard Ratio|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.8|||Stratified Log-rank Test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.80|0.54|<0.0001
74039188|NCT03783442|147632084|SUPERIORITY||Stratified Hazard Ratio|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.75|||Stratified Log-rank test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.75|0.52|<0.0001
74091474|NCT04280705|147736857|SUPERIORITY||Cox Proportional Hazard|1.23||||0.002|TWO_SIDED|95.0|1.08|1.41|||Log Rank|||||1.41|1.08|0.002
74091475|NCT04280705|147736858|SUPERIORITY||Cox Proportional Hazard|1.29|||<|0.001|TWO_SIDED|95.0|1.12|1.48|||Log Rank|||||1.48|1.12|<0.001
74091476|NCT04280705|147736859|SUPERIORITY||Cox Proportional Hazard|1.27|||<|0.001|TWO_SIDED|95.0|1.1|1.46|||Log Rank|||||1.46|1.10|<0.001
74091477|NCT04280705|147736860|SUPERIORITY||Cox Proportional Hazard|1.07|||||TWO_SIDED|95.0|0.73|1.58||||||This analysis is for Asian participants||1.58|0.73|
74091478|NCT04280705|147736860|SUPERIORITY||Cox Proportional Hazard|1.25|||||TWO_SIDED|95.0|0.91|1.72||||||This analysis is for Black or African American participants||1.72|0.91|
74091479|NCT04280705|147736860|SUPERIORITY||Cox Proportional Hazard|1.29|||||TWO_SIDED|95.0|1.06|1.57||||||This analysis is for White participants||1.57|1.06|
74091480|NCT04280705|147736860|SUPERIORITY||Cox Proportional Hazard|1.68|||||TWO_SIDED|95.0|1.1|2.58||||||This analysis is for Race of Other participants||2.58|1.10|
74091481|NCT04280705|147736861|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.1|1.55||||||This analysis is for Not Hispanic or Latino participants||1.55|1.10|
74091482|NCT04280705|147736861|SUPERIORITY||Cox Proportional Hazard|1.28|||||TWO_SIDED|95.0|0.94|1.73||||||This analysis is for Hispanic or Latino participants||1.73|0.94|
74007437|NCT03823404|147564865|SUPERIORITY||||||<|0.0455||||||The interim analysis was conducted at significance level of 0.05 and the significance level was adjusted for final analysis.|mixed-effects model for repeated measure|||||||<0.0455
74007438|NCT03823404|147564866|SUPERIORITY||||||<|455|||||||Mixed Models Analysis|||||||<0455
74007439|NCT03383289|147564880|SUPERIORITY||Beta estimate of the percent who fell|0.118|STANDARD_ERROR_OF_MEAN|0.145||0.417|TWO_SIDED||||||Mixed Models Analysis|MIANALYZE was used to model missing data. Models were adjusted for the design effects of clustering.||||||0.4170
74007440|NCT03383289|147564882|OTHER|paired t test|Mean Difference (Final Values)|-1.353|STANDARD_ERROR_OF_MEAN|0.181|<|0.001|TWO_SIDED|95.0|-1.708|-0.998|||paired t test|||Analysis of adjusted mean differences using a paired t test procedure||-0.998|-1.708|<0.001
74007441|NCT03383289|147564883|SUPERIORITY||Beta|0.6364|STANDARD_ERROR_OF_MEAN|0.233||0.0064|TWO_SIDED|95.0|0.1797|1.0931|||Poisson regression|||||1.0931|0.1797|0.0064
74007442|NCT03383289|147564883|SUPERIORITY||Estimated log mean|-4.0168||||0.001|TWO_SIDED|95.0|-5.5827|-2.4509|||Poisson regression|||||-2.4509|-5.5827|0.001
74007443|NCT03383289|147564884|OTHER|adjusted mean differences from paired t tests|Mean Difference (Final Values)|-0.456|STANDARD_ERROR_OF_MEAN|0.162||0.005|TWO_SIDED|95.0|-0.774|-0.138|||paired t test|||||-0.138|-0.774|0.005
74039189|NCT03783442|147632085|SUPERIORITY||Odds Ratio (OR)|2.38|||<|0.0001|TWO_SIDED|95.0|1.73|3.27|||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test was stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.|Odds ratio was calculated using the Cochran-Mantel-Haenszel method, stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.|||3.27|1.73|<0.0001
74039190|NCT03783442|147632086|SUPERIORITY||Stratified Hazard Ratio|0.62||||0.0029|TWO_SIDED|95.0|0.44|0.87|||Stratified Log-rank test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.87|0.44|0.0029
74039191|NCT03783442|147632088|SUPERIORITY||Least Squares (LS) Mean Difference|4.4||||0.1372|TWO_SIDED|95.0|-1.4|10.3|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Dysphagia Score at Cycle 6||10.3|-1.4|0.1372
74039192|NCT03783442|147632088|SUPERIORITY||LS Mean Difference|0.6||||0.713|TWO_SIDED|95.0|-2.5|3.7|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Eating Score at Cycle 6||3.7|-2.5|0.7130
74039193|NCT03783442|147632088|SUPERIORITY||LS Mean Difference|-1.4||||0.3001|TWO_SIDED|95.0|-4.1|1.3|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Reflux Score at Cycle 6||1.3|-4.1|0.3001
74039194|NCT03783442|147632088|OTHER||LS Mean Difference|-1.9|||||TWO_SIDED|95.0|-3.9|0.2|||||Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Pain Score at Cycle 6||0.2|-3.9|
74039195|NCT03783442|147632088|OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-2.1|1.4|||||Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Index Score at Cycle 6||1.4|-2.1|
74091483|NCT04280705|147736862|SUPERIORITY||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|1.09|1.56||||||This analysis is for Male participants||1.56|1.09|
74039196|NCT03783442|147632089|OTHER||LS Mean Difference|3.3|||||TWO_SIDED|95.0|0.4|6.2|||||Based on a mixed effect model analysis, with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6||6.2|0.4|
74039197|NCT03783442|147632089|OTHER||LS Mean Difference|2.6|||||TWO_SIDED|95.0|0.0|5.1|||||Based on a mixed effect model analysis, with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in Physical Functioning at Cycle 6||5.1|0.0|
74039198|NCT03783442|147632090|OTHER||LS Mean Difference|-1.4|||||TWO_SIDED|95.0|-4.7|1.9|||||Based on a mixed effect model analysis with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|||1.9|-4.7|
74039199|NCT00881361|147632096|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
74039200|NCT04015440|147632102|OTHER|Linear Regression|||||<|0.001|||||||Regression, Linear|||||||<.001
74039201|NCT04015440|147632103|OTHER|Regression||||||0.027|||||||Regression, Linear|||||||.027
74039202|NCT04015440|147632104|OTHER|Logistic Regression||||||0.004|||||||Regression, Logistic|||||||.004
74039203|NCT01413542|147632106|SUPERIORITY_OR_OTHER||Estimate of Difference||||<|0.001|TWO_SIDED|||||Effect of ACE inhibition on FBF response to bradykinin (p\<0.001). Other comparisons: Effect of DPP4 inhibition on FBF response to bradykinin (p=0.89); Effect of ACE (p=0.16), DPP4 (p=0.82), or combined inhibition (p=0.35) on FBF response to sub P.|Mixed Models Analysis|"Effect of DPP4 inhibition on vasodilator response to GLP-1 (p=0.14) or BNP (p=0.85).~p\<0.05 threshold for statistical significance."||"Group 1: The effect of treatment (placebo, ACE or DPP4 inhibitor, or the combination) on vasodilator response to peptide, measured as forearm blood flow was determined.~Group 2: The effect of treatment (placebo, DPP4 inhibitor) on vasodilator response to peptide, measured as percent change in forearm blood flow was determined."||||<0.001
74039204|NCT01413542|147632107|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Effect of DPP4 inhibition on tPA release during sub P in women (p=0.02 vs. placebo).Effect of ACE inhibition on tPA release during sub P in women (p\<0.001); effect of DPP4 inhibition on tPA release during sub P and (p=0.001 vs. ACE inhibition alone).|Mixed Models Analysis|p\<0.05 threshold for statistical significance||||||0.02
74091484|NCT04280705|147736862|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.03|1.66||||||This analysis is for Female participants||1.66|1.03|
74091485|NCT03222583|147736863|NON_INFERIORITY|The percentage of participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 96% if the lower confidence bound (LCB) of the 2-sided 95% confidence interval (CI) for the percentage was \> 90%.|Percentage of Participants with SVR12|97.2|||||TWO_SIDED|95.0|95.5|98.9||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||98.9|95.5|
74007444|NCT04439071|147564892|OTHER|||||||0.949|||||||Log Rank|||Time to respiratory improvement was compared between treatment groups using stratified log-rank test.||||0.949
74007445|NCT04439071|147564911|OTHER|||||||0.033|||||||Log Rank|||Time to respiratory improvement was compared between treatment groups using stratified log-rank test.||||0.033
74039205|NCT01413542|147632108|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Effect of combined ACE and DPP4 inhibition on change in heart rate in response to max dose substance P (p=0.011 vs placebo; ).|Wilcoxon signed rank|p\<0.05 threshold for statistical significance.||||||0.011
74039206|NCT01413542|147632109|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with placebo.|Wilcoxon signed rank|||||||0.05
74039207|NCT01413542|147632109|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with ACE inhibition alone (p=0.007).|Wilcoxon signed rank|||||||0.007
74039208|NCT01413542|147632110|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during placebo (p=0.01).|wilxocon signed rank test|||||||0.01
74039209|NCT01413542|147632110|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during sitagliptin (p=0.01).|Wilcoxon signed rank|||||||0.01
74039210|NCT01413542|147632110|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Effect of DPP4 inhibition on venous GLP-1 levels at high dose of intra-arterial GLP-1 (p=0.04 vs. placebo).|Wilcoxon signed rank|||||||0.04
74039211|NCT02505542|147632111|SUPERIORITY||Odds Ratio (OR)|18.822|||<|0.001|TWO_SIDED|95.0|9.605|38.864||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio \> 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.||38.864|9.605|<0.001
74007446|NCT01002456|147564920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.1|3.2|||||Proportional odds ratio to measure the trend of change in concordance with guideline recommendations, with Arm 1 as the comparator.|||3.2|1.1|
74039212|NCT02505542|147632111|SUPERIORITY||Odds Ratio (OR)|14.069|||<|0.001|TWO_SIDED|95.0|7.395|27.955||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio \> 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.||27.955|7.395|<0.001
74039213|NCT02505542|147632115|OTHER||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q2W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).||||<0.001
74039214|NCT02505542|147632115|OTHER||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q4W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).||||<0.001
74039215|NCT02505542|147632117|SUPERIORITY||Odds Ratio (OR)|17.94|||<|0.001|TWO_SIDED|95.0|8.95|35.961|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||35.961|8.950|<0.001
74091486|NCT03222583|147736864|NON_INFERIORITY|The percentage of GT1-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 97% if the LCB of the 2-sided 95% CI for the percentage was \> 91%.|Percentage of Participants with SVR12|99.4|||||TWO_SIDED|95.0|98.3|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||100.0|98.3|
74007447|NCT03829241|147565049|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.7||0.917|TWO_SIDED|95.0|-1.45|1.3|||Mixed Models Analysis|||Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.||1.30|-1.45|0.917
74007448|NCT00698451|147565055|SUPERIORITY_OR_OTHER||Percentage|72.2||||0.05|TWO_SIDED|95.0|58.4|83.5|||Exact Binomial Distribution|||||83.5|58.4|0.05
74039216|NCT02505542|147632117|SUPERIORITY||Odds Ratio (OR)|11.385|||<|0.001|TWO_SIDED|95.0|5.952|21.778|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||21.778|5.952|<0.001
74039217|NCT02505542|147632117|SUPERIORITY||Odds Ratio (OR)|17.653|||<|0.001|TWO_SIDED|95.0|8.333|37.399|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||37.399|8.333|<0.001
74039218|NCT02505542|147632117|SUPERIORITY||Odds Ratio (OR)|11.863|||<|0.001|TWO_SIDED|95.0|5.67|24.822|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||24.822|5.670|<0.001
74039219|NCT02505542|147632118|SUPERIORITY||Odds Ratio (OR)|20.205|||<|0.001|TWO_SIDED|95.0|9.851|41.439|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||41.439|9.851|<0.001
74007449|NCT00733304|147565081|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|1.362|||TWO_SIDED|95.0|-3.18|2.31||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 2 versus screening visit||2.31|-3.18|
74007450|NCT00733304|147565081|SUPERIORITY||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.659|||TWO_SIDED|95.0|-7.13|-0.46||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 5 versus screening visit||-0.46|-7.13|
74007451|NCT00733304|147565081|SUPERIORITY||Mean Difference (Net)|-4.15|STANDARD_ERROR_OF_MEAN|1.672|||TWO_SIDED|95.0|-7.52|-0.78||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 2 versus screening visit||-0.78|-7.52|
74007452|NCT00733304|147565081|SUPERIORITY||Mean Difference (Net)|-4.03|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-7.53|0.53||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 5 versus screening visit||0.53|-7.53|
74039220|NCT02505542|147632118|SUPERIORITY||Odds Ratio (OR)|12.07|||<|0.001|TWO_SIDED|95.0|6.275|23.218|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||23.218|6.275|<0.001
74039221|NCT02505542|147632119|SUPERIORITY||Odds Ratio (OR)|20.891|||<|0.001|TWO_SIDED|95.0|10.21|42.744|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||42.744|10.210|<0.001
74039222|NCT02505542|147632119|SUPERIORITY||Odds Ratio (OR)|10.377|||<|0.001|TWO_SIDED|95.0|5.456|19.738|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||19.738|5.456|<0.001
74039223|NCT02505542|147632120|SUPERIORITY||Odds Ratio (OR)|16.9|||<|0.001|TWO_SIDED|95.0|8.211|34.785|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||34.785|8.211|<0.001
74039224|NCT02505542|147632120|SUPERIORITY||Odds Ratio (OR)|12.072|||<|0.001|TWO_SIDED|95.0|5.954|24.476|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||24.476|5.954|<0.001
74039225|NCT02505542|147632121|SUPERIORITY||Odds Ratio (OR)|17.082|||<|0.001|TWO_SIDED|95.0|8.561|34.085|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||34.085|8.561|<0.001
74039226|NCT02505542|147632121|SUPERIORITY||Odds Ratio (OR)|11.503|||<|0.001|TWO_SIDED|95.0|5.939|22.278|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||22.278|5.939|<0.001
74039227|NCT02505542|147632122|OTHER||LS Mean Difference vs Placebo|-1.42|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.66|-1.17|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.17|-1.66|<0.001
74039228|NCT02505542|147632122|OTHER||LS Mean Difference vs Placebo|-1.21|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.45|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.96|-1.45|<0.001
74039229|NCT02505542|147632123|OTHER||LS Mean Difference vs Placebo|-2.46|STANDARD_ERROR_OF_MEAN|0.268|<|0.001|TWO_SIDED|95.0|-2.99|-1.94|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.94|-2.99|<0.001
74039230|NCT02505542|147632123|OTHER||LS Mean Difference vs Placebo|-2.24|STANDARD_ERROR_OF_MEAN|0.267|<|0.001|TWO_SIDED|95.0|-2.77|-1.72|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.72|-2.77|<0.001
74039231|NCT02505542|147632124|OTHER||LS Mean Difference vs Placebo|-1.57|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-2.04|-1.11|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.11|-2.04|<0.001
74007453|NCT00733304|147565082|SUPERIORITY||Mean Difference (Net)|8.28|STANDARD_ERROR_OF_MEAN|16.899|||TWO_SIDED|95.0|-25.72|42.29||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||For Month 1 versus Screening visit||42.29|-25.72|
74007454|NCT00733304|147565082|SUPERIORITY||Mean Difference (Net)|-1.21|STANDARD_ERROR_OF_MEAN|17.177|||TWO_SIDED|95.0|-35.73|33.31||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 2 versus Screening visit||33.31|-35.73|
74007455|NCT00733304|147565082|SUPERIORITY||Mean Difference (Net)|-5.11|STANDARD_ERROR_OF_MEAN|17.958|||TWO_SIDED|95.0|-41.08|30.86||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 3 versus Screening visit||30.86|-41.08|
74007456|NCT00733304|147565082|SUPERIORITY||Mean Difference (Net)|-9.92|STANDARD_ERROR_OF_MEAN|18.996|||TWO_SIDED|95.0|-47.83|28.0||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 4 versus Screening visit||28.00|-47.83|
74007457|NCT00733304|147565082|SUPERIORITY||Mean Difference (Net)|2.42|STANDARD_ERROR_OF_MEAN|18.996|||TWO_SIDED|95.0|-35.5|40.33||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 5 versus Screening visit||40.33|-35.50|
74007458|NCT00733304|147565082|SUPERIORITY||Mean Difference (Net)|9.05|STANDARD_ERROR_OF_MEAN|20.931|||TWO_SIDED|95.0|-33.09|51.2||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 1 versus Screening visit||51.20|-33.09|
74007459|NCT00733304|147565082|SUPERIORITY||Mean Difference (Net)|-1.24|STANDARD_ERROR_OF_MEAN|21.29|||TWO_SIDED|95.0|-44.05|41.57||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 2 versus Screening visit||41.57|-44.05|
74007460|NCT00733304|147565082|SUPERIORITY||Mean Difference (Net)|15.39|STANDARD_ERROR_OF_MEAN|21.757|||TWO_SIDED|95.0|-28.28|59.06||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 3 versus Screening visit||59.06|-28.28|
74007461|NCT00733304|147565082|SUPERIORITY||Mean Difference (Net)|-16.82|STANDARD_ERROR_OF_MEAN|22.183|||TWO_SIDED|95.0|-61.28|27.63||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 4 versus Screening visit||27.63|-61.28|
74007462|NCT00733304|147565082|SUPERIORITY||Mean Difference (Net)|-2.16|STANDARD_ERROR_OF_MEAN|21.757|||TWO_SIDED|95.0|-45.83|41.51||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 5 versus Screening visit||41.51|-45.83|
74007463|NCT05178134|147565098|NON_INFERIORITY|Non-inferiority margin was set to -15% (on an absolute scale)|Difference in response rates|-0.02|||||TWO_SIDED|95.0|-0.108|0.069||||||||0.069|-0.108|
74007464|NCT00596934|147565101|SUPERIORITY_OR_OTHER|||||||0.015|||||||t-test, 2 sided|||Differences in each collected parameter will be evaluated using a paired t-test. If data are skewed such as in triglyceride levels, nonparametric tests will be used. P\<0.05 will be considered significant. If a significant difference can be demonstrated between baseline and 1-year results, a large scale, placebo-controlled trial will be designed using the data obtained from this pilot study||||0.015
74007465|NCT00596934|147565102|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74039232|NCT02505542|147632124|OTHER||LS Mean Difference vs Placebo|-1.43|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-1.9|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.96|-1.90|<0.001
74039233|NCT02505542|147632125|OTHER||LS Mean Difference vs Placebo|-0.2|STANDARD_ERROR_OF_MEAN|0.112|=|0.074|TWO_SIDED|95.0|-0.42|0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||0.02|-0.42|=0.074
74039234|NCT02505542|147632125|OTHER||LS Mean Difference vs Placebo|-0.24|STANDARD_ERROR_OF_MEAN|0.113|=|0.036|TWO_SIDED|95.0|-0.46|-0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.02|-0.46|=0.036
74007466|NCT00596934|147565103|SUPERIORITY_OR_OTHER|||||||0.074||||||p = 0.074|t-test, 2 sided|||||||0.074
74007467|NCT00596934|147565104|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
74007468|NCT00596934|147565105|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
74007469|NCT00596934|147565106|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
74007470|NCT00596934|147565107|SUPERIORITY_OR_OTHER|||||||0.195||||||p-value = 0.195.|t-test, 2 sided|||||||0.195
74007471|NCT00596934|147565108|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||||||0.026
74007472|NCT01214187|147565118|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|0.81||0.2072|TWO_SIDED||||||ANOVA|Repeated measure ANOVA|Difference = (Change from baseline to Week 12 for Carbon monoxide group) minus (Change from baseline to Week 12 for Placebo group)|||||0.2072
74007473|NCT01214187|147565119|SUPERIORITY||Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|1.57||0.5882|TWO_SIDED||||||ANOVA|Repeated Measure ANOVA|Difference = (Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)|||||0.5882
74039235|NCT02505542|147632126|SUPERIORITY||Odds Ratio (OR)|18.308|||<|0.001|TWO_SIDED|95.0|9.084|36.898|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||36.898|9.084|<0.001
74007474|NCT01214187|147565120|SUPERIORITY||Mean Difference (Net)|0.64|STANDARD_ERROR_OF_MEAN|1.93||0.7401|TWO_SIDED||||||ANOVA|Repeated Measure ANOVA|difference=(change from baseline to week 12 for CO group) minus (change from baseline to week 12 for placebo group)|||||0.7401
74007475|NCT01214187|147565121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.46|STANDARD_ERROR_OF_MEAN|18.14||0.0099|TWO_SIDED||||||ANOVA|Repeated measure ANOVA|Difference=(Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)|||||0.0099
74007476|NCT01214187|147565122|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|2.42||0.8124|TWO_SIDED||||||ANOVA|Repeated measure ANOVA||||||0.8124
74007477|NCT01178333|147565123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.98||||0.09|TWO_SIDED|95.0|0.9|4.36|||Regression, Cox|||||4.36|0.90|0.09
74007478|NCT01178333|147565123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.45|TWO_SIDED|95.0|0.65|2.66|||Regression, Cox|||||2.66|0.65|0.45
74007479|NCT01178333|147565125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.76||||0.15|TWO_SIDED|95.0|0.55|40.87|||Regression, Cox|||||40.87|0.55|0.15
74007480|NCT01178333|147565125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35||||0.78|TWO_SIDED|95.0|0.16|11.25|||Regression, Cox|||||11.25|0.16|0.78
74007481|NCT01178333|147565126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.38||||0.06|TWO_SIDED|95.0|0.98|5.79|||Regression, Cox|||||5.79|0.98|0.06
74007482|NCT01178333|147565126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.91||||0.11|TWO_SIDED|95.0|0.87|4.21|||Regression, Cox|||||4.21|0.87|0.11
74007483|NCT01178333|147565127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.8||||0.001|TWO_SIDED|95.0|1.5|5.22|||Regression, Cox|||||5.22|1.50|0.001
74007484|NCT01178333|147565127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.97||||0.02|TWO_SIDED|95.0|1.12|3.45|||Regression, Cox|||||3.45|1.12|0.02
74007485|NCT01178333|147565130|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.72
74007486|NCT01178333|147565131|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.37
74007487|NCT01178333|147565132|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.02
74007488|NCT01178333|147565133|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||ANOVA|||||||0.58
74007489|NCT01178333|147565134|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Regression, Cox|||||||0.66
74007490|NCT01178333|147565135|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||<0.01
74007491|NCT01178333|147565136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.48||||0.003|TWO_SIDED|95.0|1.35|4.55|||Regression, Cox|||||4.55|1.35|0.003
74039236|NCT02505542|147632126|SUPERIORITY||Odds Ratio (OR)|12.02|||<|0.001|TWO_SIDED|95.0|6.255|23.098|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||23.098|6.255|<0.001
74007492|NCT01178333|147565136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.07|TWO_SIDED|95.0|0.96|2.85|||Regression, Cox|||||2.85|0.96|0.07
74007493|NCT01178333|147565138|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||<0.01
74007494|NCT01178333|147565139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.72|TWO_SIDED|95.0|0.56|1.49|||Regression, Cox|||||1.49|0.56|0.72
74007495|NCT01178333|147565139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.34|TWO_SIDED|95.0|0.54|1.24|||Regression, Cox|||||1.24|0.54|0.34
74007496|NCT02308007|147565140|SUPERIORITY|||||||0.03|||||||Chi-squared, Corrected|||||||0.030
74007497|NCT02308007|147565140|SUPERIORITY|||||||0.073|||||||Chi-squared, Corrected|||||||0.073
74007498|NCT02308007|147565140|SUPERIORITY|||||||0.0204|||||||Cochran-Mantel-Haenszel|||Stratified by race (black, white, or other race)||||0.0204
74007499|NCT02308007|147565140|SUPERIORITY|||||||0.0493|||||||Cochran-Mantel-Haenszel|||Stratified by race (black, white, or other race)||||0.0493
74007500|NCT02308007|147565141|SUPERIORITY|||||||0.015|||||||Chi-squared, Corrected|||||||0.015
74007501|NCT02308007|147565141|SUPERIORITY|||||||0.193|||||||Chi-squared, Corrected|||Difference for Terconazole/metronidazole vaginal gel cures minus metronidazole vaginal gel cures||||0.193
74007502|NCT02308007|147565142|SUPERIORITY|||||||0.012|||||||Chi-squared, Corrected|||||||0.012
74007503|NCT02308007|147565142|SUPERIORITY|||||||0.918|||||||Chi-squared, Corrected|||||||0.918
74007504|NCT01241552|147565154|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.7||||0.3182|TWO_SIDED|95.0|-8.6|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||5.5|-8.6|0.3182
74007505|NCT01241552|147565154|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.1||||0.0003|TWO_SIDED|95.0|-15.9|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||-4.3|-15.9|0.0003
74007506|NCT01241552|147565154|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.6|||<|0.0001|TWO_SIDED|95.0|-17.4|-5.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||-5.9|-17.4|< 0.0001
74007507|NCT01241552|147565154|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.9||||0.0013|TWO_SIDED|95.0|-16.9|-3.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||-3.4|-16.9|0.0013
74007508|NCT01241552|147565154|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.4||||0.2997|TWO_SIDED|95.0|-6.7|3.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||3.9|-6.7|0.2997
74007509|NCT01241552|147565155|SUPERIORITY_OR_OTHER||Adjusted Difference|-8.3||||0.9775|TWO_SIDED|95.0|-16.3|-0.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||-0.2|-16.3|0.9775
73957629|NCT00383188|147451045|SUPERIORITY||LSM Difference|-4.766|STANDARD_ERROR_OF_MEAN|4.053||0.2401|TWO_SIDED|95.0|-12.72|3.191|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||3.191|-12.72|0.2401
73957630|NCT00383188|147451045|SUPERIORITY||LSM Difference|-11.07|STANDARD_ERROR_OF_MEAN|3.983||0.0056|TWO_SIDED|95.0|-18.89|-3.251|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-3.251|-18.89|0.0056
73957631|NCT00383188|147451045|SUPERIORITY||LSM Difference|-8.885|STANDARD_ERROR_OF_MEAN|4.654||0.0566|TWO_SIDED|95.0|-18.02|0.251|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||0.251|-18.02|0.0566
73957632|NCT00383188|147451045|SUPERIORITY||LSM Difference|-10.09|STANDARD_ERROR_OF_MEAN|4.772||0.0348|TWO_SIDED|95.0|-19.45|-0.72|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-0.720|-19.45|0.0348
73957633|NCT00383188|147451045|SUPERIORITY||LSM Difference|4.89|STANDARD_ERROR_OF_MEAN|4.191||0.2436|TWO_SIDED|95.0|-3.336|13.116|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||13.116|-3.336|0.2436
73957634|NCT00383188|147451045|SUPERIORITY||LSM Difference|-1.781|STANDARD_ERROR_OF_MEAN|4.066||0.6616|TWO_SIDED|95.0|-9.762|6.201|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||6.201|-9.762|0.6616
73957635|NCT00383188|147451045|SUPERIORITY||LSM Difference|3.907|STANDARD_ERROR_OF_MEAN|4.83||0.4189|TWO_SIDED|95.0|-5.574|13.388|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||13.388|-5.574|0.4189
73957636|NCT00383188|147451045|SUPERIORITY||LSM Difference|4.395|STANDARD_ERROR_OF_MEAN|4.942||0.3741|TWO_SIDED|95.0|-5.305|14.096|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||14.096|-5.305|0.3741
73957637|NCT00383188|147451046|SUPERIORITY||LSM Difference|-2.996|STANDARD_ERROR_OF_MEAN|3.958||0.4493|TWO_SIDED|95.0|-10.77|4.773|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.773|-10.77|0.4493
73957638|NCT00383188|147451046|SUPERIORITY||LSM Difference|-14.45|STANDARD_ERROR_OF_MEAN|3.891||0.0002|TWO_SIDED|95.0|-22.08|-6.807|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-6.807|-22.08|0.0002
73957639|NCT00383188|147451046|SUPERIORITY||LSM Difference|-11.54|STANDARD_ERROR_OF_MEAN|4.522||0.0109|TWO_SIDED|95.0|-20.42|-2.661|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.661|-20.42|0.0109
73957640|NCT00383188|147451046|SUPERIORITY||LSM Difference|-7.364|STANDARD_ERROR_OF_MEAN|4.651||0.1137|TWO_SIDED|95.0|-16.49|1.765|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||1.765|-16.49|0.1137
73957641|NCT00383188|147451046|SUPERIORITY||LSM Difference|-3.989|STANDARD_ERROR_OF_MEAN|3.915||0.3086|TWO_SIDED|95.0|-11.68|3.697|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.697|-11.68|0.3086
73957642|NCT00383188|147451046|SUPERIORITY||LSM Difference|-8.357|STANDARD_ERROR_OF_MEAN|3.85||0.0303|TWO_SIDED|95.0|-15.92|-0.799|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.799|-15.92|0.0303
73957643|NCT00383188|147451046|SUPERIORITY||LSM Difference|-10.66|STANDARD_ERROR_OF_MEAN|4.489||0.0178|TWO_SIDED|95.0|-19.47|-1.845|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.845|-19.47|0.0178
73957644|NCT00383188|147451046|SUPERIORITY||LSM Difference|-5.325|STANDARD_ERROR_OF_MEAN|4.612||0.2486|TWO_SIDED|95.0|-14.38|3.729|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.729|-14.38|0.2486
74007510|NCT01241552|147565155|SUPERIORITY_OR_OTHER||Adjusted Difference|4.8||||0.0861|TWO_SIDED|95.0|-2.1|11.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||11.7|-2.1|0.0861
74007511|NCT01241552|147565155|SUPERIORITY_OR_OTHER||Adjusted Difference|3.5||||0.1646|TWO_SIDED|95.0|-3.5|10.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||10.4|-3.5|0.1646
74007512|NCT01241552|147565155|SUPERIORITY_OR_OTHER||Adjusted Difference|11.7||||0.0025|TWO_SIDED|95.0|3.5|19.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||19.7|3.5|0.0025
74007513|NCT01241552|147565155|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.4||||0.6532|TWO_SIDED|95.0|-8.3|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||5.5|-8.3|0.6532
74007514|NCT01241552|147565156|SUPERIORITY_OR_OTHER||Adjusted Difference|1.7||||0.6505|TWO_SIDED|95.0|-6.9|10.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||10.7|-6.9|0.6505
74007515|NCT01241552|147565156|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.8||||0.0013|TWO_SIDED|95.0|-17.7|-3.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||-3.8|-17.7|0.0013
74007516|NCT01241552|147565156|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.7||||0.0006|TWO_SIDED|95.0|-18.6|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||-4.7|-18.6|0.0006
74007517|NCT01241552|147565156|SUPERIORITY_OR_OTHER||Adjusted Difference|-13.7||||0.0007|TWO_SIDED|95.0|-22.5|-5.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||-5.2|-22.5|0.0007
74007518|NCT01241552|147565156|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.0||||0.3906|TWO_SIDED|95.0|-7.7|5.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||5.8|-7.7|0.3906
74007519|NCT01241552|147565157|SUPERIORITY_OR_OTHER||Percentage Difference|5.2||||0.185|TWO_SIDED|95.0|-2.5|12.8|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||12.8|-2.5|0.185
74007520|NCT01241552|147565157|SUPERIORITY_OR_OTHER||Percentage Difference|3.4||||0.323|TWO_SIDED|95.0|-3.3|10.1|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||10.1|-3.3|0.323
74007521|NCT01241552|147565157|SUPERIORITY_OR_OTHER||Percentage Difference|-2.3||||0.507|TWO_SIDED|95.0|-9.1|4.5|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||4.5|-9.1|0.507
74007522|NCT01241552|147565158|SUPERIORITY_OR_OTHER||Percentage Difference|2.2||||0.246|TWO_SIDED|95.0|-1.5|6.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||6.7|-1.5|0.246
74007523|NCT01241552|147565158|SUPERIORITY_OR_OTHER||Percentage Difference|3.2||||0.069|TWO_SIDED|95.0|-0.3|6.8|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||6.8|-0.3|0.069
74007524|NCT01241552|147565158|SUPERIORITY_OR_OTHER||Percentage Difference|1.2||||0.464|TWO_SIDED|95.0|-2.1|4.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||4.6|-2.1|0.464
74007525|NCT01241552|147565159|SUPERIORITY_OR_OTHER||Percentage Difference|7.7||||0.027|TWO_SIDED|95.0|0.9|14.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||14.7|0.9|0.027
74007526|NCT01241552|147565159|SUPERIORITY_OR_OTHER||Percentage Difference|1.5||||0.594|TWO_SIDED|95.0|-4.1|7.2|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||7.2|-4.1|0.594
74007527|NCT01241552|147565159|SUPERIORITY_OR_OTHER||Percentage Difference|-5.3||||0.051|TWO_SIDED|95.0|-10.6|0.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||0.0|-10.6|0.051
74007528|NCT01241552|147565160|SUPERIORITY_OR_OTHER||Percentage Difference|1.0||||0.115|TWO_SIDED|95.0|-0.3|3.5|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.5|-0.3|0.115
74007529|NCT01241552|147565160|SUPERIORITY_OR_OTHER||Percentage Difference|0.8||||0.17|TWO_SIDED|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||2.4|-0.5|0.170
74007530|NCT01241552|147565160|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.544|TWO_SIDED|95.0|-0.9|1.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placeb + SOC|||1.6|-0.9|0.544
74007531|NCT01241552|147565161|SUPERIORITY_OR_OTHER||Percentage Difference|0.4||||0.192|TWO_SIDED|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||2.4|-0.5|0.192
74007532|NCT01241552|147565161|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.311|TWO_SIDED|95.0|-0.7|1.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||1.4|-0.7|0.311
74007533|NCT01241552|147565161|SUPERIORITY_OR_OTHER||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||1.0|-1.0|> 0.999
74007534|NCT01241552|147565162|SUPERIORITY_OR_OTHER||Percentage Difference|3.6|||||TWO_SIDED|95.0|-1.0|8.7|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||8.7|-1.0|
74007535|NCT01241552|147565162|SUPERIORITY_OR_OTHER||Percentage Difference|4.3|||||TWO_SIDED|95.0|0.2|8.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||8.5|0.2|
74007536|NCT01241552|147565162|SUPERIORITY_OR_OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-2.6|5.2|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||5.2|-2.6|
74007537|NCT01241552|147565163|SUPERIORITY_OR_OTHER||Percentage Difference|-6.9|||||TWO_SIDED|95.0|-16.8|3.5|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.5|-16.8|
74007538|NCT01241552|147565163|SUPERIORITY_OR_OTHER||Percentage Difference|-18.0|||||TWO_SIDED|95.0|-26.3|-9.6|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-9.6|-26.3|
74007539|NCT01241552|147565163|SUPERIORITY_OR_OTHER||Percentage Difference|-16.2|||||TWO_SIDED|95.0|-24.5|-7.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-7.7|-24.5|
74007540|NCT01241552|147565164|SUPERIORITY_OR_OTHER||Percentage Difference|-6.1|||||TWO_SIDED|95.0|-20.1|8.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||8.6|-20.1|
74007541|NCT01241552|147565164|SUPERIORITY_OR_OTHER||Percentage Difference|-13.2|||||TWO_SIDED|95.0|-25.5|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-0.5|-25.5|
74007542|NCT01241552|147565164|SUPERIORITY_OR_OTHER||Percentage Difference|-14.4|||||TWO_SIDED|95.0|-26.8|-1.6|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-1.6|-26.8|
74007543|NCT01241552|147565165|SUPERIORITY_OR_OTHER||Percentage Difference|0.8|||||TWO_SIDED|95.0|-16.9|21.0|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||21.0|-16.9|
74007544|NCT01241552|147565165|SUPERIORITY_OR_OTHER||Percentage Difference|-14.6|||||TWO_SIDED|95.0|-28.3|-1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-1.4|-28.3|
74007545|NCT01241552|147565165|SUPERIORITY_OR_OTHER||Percentage Difference|-12.1|||||TWO_SIDED|95.0|-26.2|1.9|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||1.9|-26.2|
74007546|NCT01241552|147565166|SUPERIORITY_OR_OTHER||Percentage Difference|-10.0|||||TWO_SIDED|95.0|-30.1|10.0|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||10.0|-30.1|
74039864|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.17||0.1209|TWO_SIDED|95.0|-0.59|0.07|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.59|0.1209
74007547|NCT01241552|147565166|SUPERIORITY_OR_OTHER||Percentage Difference|-25.3|||||TWO_SIDED|95.0|-43.7|-6.1|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-6.1|-43.7|
74007548|NCT01241552|147565167|SUPERIORITY_OR_OTHER||Percentage Difference|-11.3|||||TWO_SIDED|95.0|-24.9|3.9|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.9|-24.9|
74007549|NCT01241552|147565167|SUPERIORITY_OR_OTHER||Percentage Difference|-12.7|||||TWO_SIDED|95.0|-24.7|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-0.5|-24.7|
74007550|NCT01241552|147565167|SUPERIORITY_OR_OTHER||Percentage Difference|-16.0|||||TWO_SIDED|95.0|-27.8|-4.0|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-4.0|-27.8|
74007551|NCT01241552|147565168|SUPERIORITY_OR_OTHER||Percentage Difference|-10.1|||||TWO_SIDED|95.0|-23.2|4.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||4.6|-23.2|
74007552|NCT01241552|147565168|SUPERIORITY_OR_OTHER||Percentage Difference|-11.0|||||TWO_SIDED|95.0|-23.2|1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||1.4|-23.2|
74007553|NCT01241552|147565168|SUPERIORITY_OR_OTHER||Percentage Difference|-16.7|||||TWO_SIDED|95.0|-28.4|-4.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-4.7|-28.4|
74007554|NCT00528567|147565169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.181|TWO_SIDED|95.0|0.72|1.07|||Log Rank|Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.||||1.07|0.72|0.1810
74007555|NCT00528567|147565171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5247|TWO_SIDED|95.0|0.74|1.17|||Log Rank|Stratification factors are Axillary nodal status, Choice of adjuvant chemotherapy, Hormone receptor status, Surgery||||1.17|0.74|0.5247
74007556|NCT00528567|147565173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1966|TWO_SIDED|95.0|0.71|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.07|0.71|0.1966
74007557|NCT00528567|147565174|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2318|TWO_SIDED|95.0|0.64|1.12|||Log Rank|||||1.12|0.64|0.2318
74007558|NCT00528567|147565177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2792|TWO_SIDED|95.0|0.72|1.1|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.10|0.72|0.2792
74007559|NCT00528567|147565179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1832|TWO_SIDED|95.0|0.72|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.07|0.72|0.1832
74007560|NCT00528567|147565181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.3309|TWO_SIDED|95.0|0.72|1.12|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.12|0.72|0.3309
74007561|NCT00729781|147565208|SUPERIORITY_OR_OTHER||Percent of subjects with improvement|57.8||||0.19|ONE_SIDED|97.5|42.2||||One-sided, binomial exact test|||This study had two independent primary endpoints (cosmetic and functional improvement). Therefore, the assumed type I error rate for each was 2.5% in order to maintain an overall 5% type I error rate. For each endpoint, the percent of subjects with improvement of the total number implanted was to be compared to a rate of 50% using a one-sided, binomial exact test. If the p-value was \< 0.025, the objective would have been met.|||42.2|0.19
74007562|NCT00729781|147565209|SUPERIORITY_OR_OTHER||Percent of subjects with improvement|15.6|||>|0.99|ONE_SIDED|97.5|0.05||||One-sided, binomial exact test||||||0.05|>0.99
74007563|NCT01026142|147565260|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0731|TWO_SIDED|95.0|0.65|1.02||The primary endpoint, IRF-assessed PFS, is tested at a two-sided 5% significance level.|Log Rank|Two-sided and stratified by: prior CNS disease present/absent, measurable disease at baseline, and response to trastuzumab in 1L metastatic setting.|The stratified Cox proportional hazard model will be used to estimate the HR between the two treatment arms and its 95% CI.|"The null hypothesis for the primary endpoint is that the survival distributions of IRF-assessed PFS in the two treatment groups are the same. The alternative hypothesis is that the survival distributions of IRF-assessed PFS in the treatment and the control arms are different:~H0: IRF PFS\<pertuzumab\> = IRF PFS\<control\> vs. H1: IRF PFS\<pertuzumab\> ≠ IRF PFS\<control\>"||1.02|0.65|0.0731
74007564|NCT00846885|147565269|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||117|103|
74007565|NCT00846885|147565270|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|106.0||||||90.0|102.0|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111|102|
74007566|NCT00846885|147565271|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|101.0|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|101|
74007567|NCT02113579|147565405|SUPERIORITY_OR_OTHER||Success rate difference (%)|24.7|||<|0.001|TWO_SIDED|||||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05) with estimated difference of \>= 20%, testing proceeded to Mean Cold Air Stimulus VAS Score at Week 4. Family-wise error was controlled at 0.05.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 4, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.||||<0.001
74007568|NCT02113579|147565406|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.27|STANDARD_ERROR_OF_MEAN|2.239|<|0.001|TWO_SIDED|95.0|-18.68|-9.87||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05), testing proceeded to Mean Tactile Sensitivity Score at Week 4. Family-wise error was controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-9.87|-18.68|<0.001
74007569|NCT02113579|147565407|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.45|STANDARD_ERROR_OF_MEAN|1.844|<|0.001|TWO_SIDED|95.0|9.83|17.08||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05), testing proceeded to Mean Cold Air Stimulus VAS Score at Week 2 and Mean Tactile Sensitivity Score at Week 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||17.08|9.83|<0.001
74007570|NCT02113579|147565408|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.67|STANDARD_ERROR_OF_MEAN|1.809|<|0.001|TWO_SIDED|95.0|-11.23|-4.11||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-4.11|-11.23|<0.001
74007571|NCT02113579|147565409|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|0.975|<|0.001|TWO_SIDED|95.0|2.78|6.62||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.62|2.78|<0.001
74007572|NCT02113579|147565410|SUPERIORITY_OR_OTHER||Success rate difference (%)|15.44||||0.002|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 2, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.||||0.002
74007573|NCT02113579|147565411|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.67|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|-9.92|-3.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.43|-9.92|<0.001
74007574|NCT02113579|147565412|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.52|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-15.3|-7.75||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-7.75|-15.30|<0.001
74007575|NCT02113579|147565413|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.422||0.023|TWO_SIDED|95.0|-6.04|-0.45||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.45|-6.04|0.023
74007576|NCT02113579|147565414|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.61|STANDARD_ERROR_OF_MEAN|1.873|<|0.001|TWO_SIDED|95.0|-11.29|-3.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups||-3.93|-11.29|<0.001
74007577|NCT02217436|147565415|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
74007578|NCT02217436|147565416|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
74007579|NCT03034460|147565427|SUPERIORITY||||||=|0.158|||||||Wilcoxon rank signed test|||This analysis was performed in participants applied CD5024 1% Cream on one side of face and CD5024 1% Cream Matched Placebo on other side of face for paired difference between Active - Vehicle (CD5024 1% Cream \[n=48\] versus CD5024 1% Cream Matched Placebo \[n=48\]).||||= 0.158
74007580|NCT03034460|147565427|SUPERIORITY||||||=|0.002|||||||Wilcoxon rank signed test|||This analysis was performed in participants applied Adapalene Benzoyl Peroxyde on one side of face and Adapalene Benzoyl Peroxyde Matched Placebo on the other side of face for paired difference between Active - Vehicle (Adapalene Benzoyl Peroxyde \[n=22\] versus Adapalene Benzoyl Peroxyde Matched Placebo \[n=22\]).||||= 0.002
74007581|NCT01798992|147565438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685|TWO_SIDED||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.||||0.685
74007582|NCT01798992|147565439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|TWO_SIDED||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.||||0.071
74007583|NCT01191541|147565495|NON_INFERIORITY|The primary objective was to demonstrate the noninferiority of DNR alone to DNR+ARA-C in the rate of DFS at 2 years. Assuming a 95% rate of DFS in the two groups, a margin of -15% , 5% type 1 error, 80% power, 30 evaluable patients per group were required to draw a noninferiority conclusion.|||||<|0.05||||||the p-value is not adjusted|Log Rank|||The characteristics of all of the included patients were summarized using cross-tabulations (for categorical variables) and quantiles. Nonparametric tests were used to analyse comparisons between groups .EFS、disease-free survival (DFS) and OS were estimated using the Kaplan -Meier method, and log-rank tests were used. All P values were two-sided, and those with values of 0.05 or less were considered to be statistically significant.||||<0.05
74007584|NCT01936909|147565571|SUPERIORITY||||||>|0.2|||||||ANOVA|||This test reflects a comparison between baseline and 2 weeks (both rows).||||>0.20
74007585|NCT01936909|147565572|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Paired analysis versus baseline||||<0.01
74007586|NCT01936909|147565573|SUPERIORITY|Log-rank test||||||0.12|||||||Log Rank|||||||0.12
74007587|NCT00744211|147565574|SUPERIORITY_OR_OTHER||||||<|0.05||||||p\<0.05; Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA|||||||<0.05
74007588|NCT00744211|147565575|SUPERIORITY_OR_OTHER|||||||0.001||||||Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA|||||||0.001
74007589|NCT00744211|147565576|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74007590|NCT00744211|147565577|EQUIVALENCE|Chi-square tests for differences between groups.||||||0.015||||||P-value is associated with the hematological/lymphatic adverse event.|Chi-squared|||||||0.015
74007591|NCT00038727|147565599|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.87|TWO_SIDED|95.0|0.81|1.28|||Log Rank|||||1.28|0.81|0.87
74007592|NCT00038727|147565599|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.79|1.25|||Log Rank|||||1.25|0.79|0.95
74007593|NCT03740997|147565602|OTHER||Mean Difference (Net)|16.2|STANDARD_DEVIATION|5.46||0.0008|TWO_SIDED|95.0|10.44|21.89|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1||21.89|10.44|0.0008
74007594|NCT03740997|147565602|OTHER||Mean Difference (Net)|17.1|STANDARD_DEVIATION|13.49|<|0.0001|TWO_SIDED|95.0|11.11|23.07|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1||23.07|11.11|<0.0001
74007595|NCT03740997|147565602|OTHER||Mean Difference (Net)|19.3|STANDARD_DEVIATION|6.5||0.0002|TWO_SIDED|95.0|13.28|25.3|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2||25.30|13.28|0.0002
74007596|NCT03740997|147565602|OTHER||Mean Difference (Net)|18.5|STANDARD_DEVIATION|11.68|<|0.0001|TWO_SIDED|95.0|13.47|23.57|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2||23.57|13.47|<0.0001
74007597|NCT03740997|147565602|OTHER||Mean Difference (Net)|19.8|STANDARD_DEVIATION|3.06|<|0.0001|TWO_SIDED|95.0|16.62|23.05|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1||23.05|16.62|<0.0001
74007598|NCT03740997|147565602|OTHER||Mean Difference (Net)|20.1|STANDARD_DEVIATION|13.38|<|0.0001|TWO_SIDED|95.0|14.16|26.03|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1||26.03|14.16|<0.0001
74039237|NCT02505542|147632127|OTHER||LS Mean Difference vs Placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.76|=|0.195|TWO_SIDED|95.0|-2.5|0.51|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.51|-2.50|=0.195
74007599|NCT03740997|147565602|OTHER||Mean Difference (Net)|22.0|STANDARD_DEVIATION|2.77|<|0.0001|TWO_SIDED|95.0|19.44|24.56|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2||24.56|19.44|<0.0001
74007600|NCT03740997|147565602|OTHER||Mean Difference (Net)|21.2|STANDARD_DEVIATION|13.34|<|0.0001|TWO_SIDED|95.0|15.45|26.99|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2||26.99|15.45|<0.0001
74007601|NCT03740997|147565602|OTHER||Mean Difference (Net)|11.8|STANDARD_DEVIATION|9.35||0.0268|TWO_SIDED|95.0|2.02|21.64|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1||21.64|2.02|0.0268
74007602|NCT03740997|147565602|OTHER||Mean Difference (Net)|16.1|STANDARD_DEVIATION|15.08|<|0.0001|TWO_SIDED|95.0|9.45|22.82|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1||22.82|9.45|<0.0001
74007603|NCT03740997|147565602|OTHER||Mean Difference (Net)|12.1|STANDARD_DEVIATION|6.59||0.0028|TWO_SIDED|95.0|6.04|18.24|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2||18.24|6.04|0.0028
74007604|NCT03740997|147565602|OTHER||Mean Difference (Net)|15.8|STANDARD_DEVIATION|13.37|<|0.0001|TWO_SIDED|95.0|10.04|21.61|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2||21.61|10.04|<0.0001
74039238|NCT02505542|147632127|OTHER||LS Mean Difference vs Placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.76|=|0.432|TWO_SIDED|95.0|-2.11|0.91|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.91|-2.11|=0.432
74039865|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.0107|TWO_SIDED|95.0|-0.76|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.76|0.0107
74039866|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.19||0.2396|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.61|0.2396
74039867|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.1088|TWO_SIDED|95.0|-0.69|0.07|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.69|0.1088
74039868|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1673|TWO_SIDED|95.0|-0.65|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.65|0.1673
74039869|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1751|TWO_SIDED|95.0|-0.66|0.12|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.66|0.1751
74039870|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3164|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.59|0.3164
74039871|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.2253|TWO_SIDED|95.0|-0.62|0.15|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.62|0.2253
74039872|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.3408|TWO_SIDED|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.58|0.3408
74039873|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.3391|TWO_SIDED|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.58|0.3391
74039874|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5818|TWO_SIDED|95.0|-0.5|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.50|0.5818
74039875|NCT02528253|147632457|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2562|TWO_SIDED|95.0|-0.62|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.62|0.2562
74039876|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.0137|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.69|0.0137
74039877|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0044|TWO_SIDED|95.0|-0.76|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.14|-0.76|0.0044
74039878|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6194|TWO_SIDED|95.0|-0.35|0.21|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.35|0.6194
74007605|NCT01829425|147565615|NON_INFERIORITY|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%.|Difference in median % change between gr|5.0|||<|0.025|ONE_SIDED|95.0|5.0||||Exact Mann Whitney|Due dispersion, medians were calculated. Exact Mann Whitney test was used for this analysis.|Hypnotherapy - Pharmacotherapy. % difference in median % change in UUI episodes with lower bounds \> - 5% would be consistent with non-inferiority||||5|<.025
74007606|NCT01829425|147565616|NON_INFERIORITY|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%. If|Difference in median % change between gr|5.0|||<|0.025|ONE_SIDED|95.0|5.0||||Exact Mann Whitney||||||5|<.025
74007607|NCT01862640|147565628|SUPERIORITY||Least square (LS) mean difference|-3.77|||=|0.0404|TWO_SIDED|95.0|-7.38|-0.17|||Mixed-effect model repeated measure|||||-0.17|-7.38|=0.0404
74007608|NCT01862640|147565628|SUPERIORITY||LS mean difference|0.23|||=|0.9015|TWO_SIDED|95.0|-3.4|3.86|||Mixed-effect model repeated measure|||||3.86|-3.40|=0.9015
74007609|NCT01862640|147565629|SUPERIORITY||LS mean difference|-0.16|||=|0.1566|TWO_SIDED|95.0|-0.39|0.06|||Mixed-effect model repeated measure|||||0.06|-0.39|=0.1566
74007610|NCT01862640|147565629|SUPERIORITY||LS mean difference|0.09|||=|0.444|TWO_SIDED|95.0|-0.14|0.32|||Mixed-effect model repeated measure|||||0.32|-0.14|=0.4440
74007611|NCT04178967|147565630|SUPERIORITY||Risk Difference (RD)|21.9||||4e-06|TWO_SIDED|95.0|14.2|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.2|0.000004
74007612|NCT04178967|147565631|SUPERIORITY||Risk Difference (RD)|33.3|||<|1e-06|TWO_SIDED|95.0|24.4|42.2|||Cochran-Mantel-Haenszel|||||42.2|24.4|<0.000001
74007613|NCT04178967|147565632|SUPERIORITY||Risk Difference (RD)|0.7||||0.308463|TWO_SIDED|95.0|-0.3|1.7|||Cochran-Mantel-Haenszel|||||1.7|-0.3|0.308463
74007614|NCT04178967|147565633|SUPERIORITY||Risk Difference (RD)|8.1||||0.001607|TWO_SIDED|95.0|4.1|12.0|||Cochran-Mantel-Haenszel|||||12.0|4.1|0.001607
74007615|NCT04178967|147565634|SUPERIORITY||Risk Difference (RD)|21.9||||4e-06|TWO_SIDED|95.0|14.2|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.2|0.000004
74007616|NCT04178967|147565635|SUPERIORITY||Risk Difference (RD)|20.7||||8e-06|TWO_SIDED|95.0|13.3|28.1|||Cochran-Mantel-Haenszel|||||28.1|13.3|0.000008
74007617|NCT04178967|147565636|SUPERIORITY||LS Mean Difference (Final Values)|-27.53|||<|1e-06|TWO_SIDED|95.0|-34.9|-20.2|||ANCOVA|||||-20.2|-34.9|<0.000001
74007618|NCT04178967|147565637|SUPERIORITY||Risk Difference (RD)|28.3|||<|1e-06|TWO_SIDED|95.0|20.0|36.5|||Cochran-Mantel-Haenszel|||||36.5|20.0|<0.000001
74007619|NCT04178967|147565638|SUPERIORITY||Risk Difference (RD)|29.7|||<|1e-06|TWO_SIDED|95.0|21.0|38.4|||Cochran-Mantel-Haenszel|||||38.4|21.0|<0.000001
74007620|NCT04178967|147565639|SUPERIORITY||LS Mean Difference (Final Values)|-33.57|||<|1e-06|TWO_SIDED|95.0|-41.2|-26.0|||ANCOVA|||||-26.0|-41.2|<0.000001
74007621|NCT04178967|147565640|SUPERIORITY||LS Mean Difference (Final Values)|-16.2|||<|1e-06|TWO_SIDED|95.0|-20.3|-12.0|||Mixed Models Analysis|||||-12.0|-20.3|<0.000001
74007622|NCT04178967|147565641|SUPERIORITY||Risk Difference (RD)|4.9||||0.022921|TWO_SIDED|95.0|1.4|8.4|||Cochran-Mantel-Haenszel|||||8.4|1.4|0.022921
74007623|NCT04178967|147565642|SUPERIORITY||LS Mean Difference (Final Values)|-4.9|||<|1e-06|TWO_SIDED|95.0|-6.3|-3.5|||ANCOVA|||||-3.5|-6.3|<0.000001
74007624|NCT04178967|147565643|SUPERIORITY||Risk Difference (RD)|32.9||||1e-06|TWO_SIDED|95.0|22.2|43.6|||Cochran-Mantel-Haenszel|||||43.6|22.2|0.000001
74007625|NCT04178967|147565644|SUPERIORITY||Risk Difference (RD)|33.0||||1e-06|TWO_SIDED|95.0|22.2|43.8|||Cochran-Mantel-Haenszel|||||43.8|22.2|0.000001
74007626|NCT04178967|147565645|SUPERIORITY||LS Mean Difference (Final Values)|-37.09|||<|1e-06|TWO_SIDED|95.0|-47.4|-26.8|||ANCOVA|||||-26.8|-47.4|<0.000001
74007627|NCT04178967|147565646|SUPERIORITY||LS Mean Difference (Final Values)|-0.7|||<|1e-06|TWO_SIDED|95.0|-0.9|-0.5|||ANCOVA|||||-0.5|-0.9|<0.000001
74007628|NCT04178967|147565647|SUPERIORITY||Risk Difference (RD)|18.9||||0.000571|TWO_SIDED|95.0|9.6|28.1|||Cochran-Mantel-Haenszel|||||28.1|9.6|0.000571
74007629|NCT04178967|147565648|SUPERIORITY||Risk Difference (RD)|0.4||||0.469221|TWO_SIDED|95.0|-0.4|1.2|||Cochran-Mantel-Haenszel|||||1.2|-0.4|0.469221
74007630|NCT04178967|147565649|SUPERIORITY||Risk Difference (RD)|2.7||||0.113194|TWO_SIDED|95.0|-0.1|5.4|||Cochran-Mantel-Haenszel|||||5.4|-0.1|0.113194
74007631|NCT04178967|147565650|SUPERIORITY||Risk Difference (RD)|13.2||||0.00023|TWO_SIDED|95.0|7.7|18.7|||Cochran-Mantel-Haenszel|||||18.7|7.7|0.000230
74007632|NCT04178967|147565651|SUPERIORITY||Risk Difference (RD)|0.4||||0.46816|TWO_SIDED|95.0|-0.4|1.3|||Cochran-Mantel-Haenszel|||||1.3|-0.4|0.468160
74007633|NCT04178967|147565652|SUPERIORITY||Risk Difference (RD)|2.9||||0.11577|TWO_SIDED|95.0|-0.1|5.8|||Cochran-Mantel-Haenszel|||||5.8|-0.1|0.115770
74007634|NCT04178967|147565653|SUPERIORITY||Risk Difference (RD)|14.2||||0.000252|TWO_SIDED|95.0|8.2|20.1|||Cochran-Mantel-Haenszel|||||20.1|8.2|0.000252
74007635|NCT04178967|147565654|SUPERIORITY||LS Mean Difference (Final Values)|-30.76|||<|1e-06|TWO_SIDED|95.0|-36.93|-24.59|||ANCOVA|||||-24.59|-36.93|<0.000001
74007636|NCT04178967|147565656|SUPERIORITY||Risk Difference (RD)|12.8||||0.238245|TWO_SIDED|95.0|-9.5|35.1|||Cochran-Mantel-Haenszel|||||35.1|-9.5|0.238245
74007637|NCT04178967|147565656|SUPERIORITY||Risk Difference (RD)|4.8||||0.612427|TWO_SIDED|95.0|-17.8|27.3|||Cochran-Mantel-Haenszel|||||27.3|-17.8|0.612427
74007638|NCT04178967|147565657|SUPERIORITY||Risk Difference (RD)|32.6||||0.033876|TWO_SIDED|95.0|2.6|62.5|||Cochran-Mantel-Haenszel|||||62.5|2.6|0.033876
74007639|NCT04178967|147565657|SUPERIORITY||Risk Difference (RD)|13.4||||0.407417|TWO_SIDED|95.0|-17.5|44.3|||Cochran-Mantel-Haenszel|||||44.3|-17.5|0.407417
74007640|NCT04178967|147565658|SUPERIORITY||Risk Difference (RD)|20.3||||0.159281|TWO_SIDED|95.0|-11.4|52.0|||Cochran-Mantel-Haenszel|||||52.0|-11.4|0.159281
74007641|NCT04178967|147565658|SUPERIORITY||Risk Difference (RD)|20.4||||0.16495|TWO_SIDED|95.0|-10.6|51.4|||Cochran-Mantel-Haenszel|||||51.4|-10.6|0.164950
74007642|NCT04178967|147565659|SUPERIORITY||Risk Difference (RD)|19.7||||0.179704|TWO_SIDED|95.0|-12.2|51.2|||Cochran-Mantel-Haenszel|||||51.2|-12.2|0.179704
74007643|NCT04178967|147565659|SUPERIORITY||Risk Difference (RD)|24.3||||0.08308|TWO_SIDED|95.0|-6.5|55.1|||Cochran-Mantel-Haenszel|||||55.1|-6.5|0.083080
74007644|NCT04178967|147565660|SUPERIORITY||LS Mean Difference (Final Values)|-6.29||||0.176748|TWO_SIDED|95.0|-15.46|2.87|||ANCOVA|||||2.87|-15.46|0.176748
74007645|NCT04178967|147565660|SUPERIORITY||LS Mean Difference (Final Values)|-6.25||||0.183151|TWO_SIDED|95.0|-15.48|2.99|||ANCOVA|||||2.99|-15.48|0.183151
74007646|NCT04178967|147565661|SUPERIORITY||LS Mean Difference (Final Values)|0.1||||1e-06|TWO_SIDED|95.0|0.1|0.1|||ANCOVA|||UK||0.1|0.1|0.000001
74007647|NCT04178967|147565661|SUPERIORITY||LS Mean Difference (Final Values)|0.1||||1e-06|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||US||0.1|0.0|0.000001
74007648|NCT04178967|147565662|SUPERIORITY||LS Mean Difference (Final Values)|4.5||||0.005304|TWO_SIDED|95.0|1.3|7.6|||ANCOVA|||||7.6|1.3|0.005304
74007649|NCT04178967|147565663|SUPERIORITY||LS Mean Difference (Final Values)|-6.0|||<|1e-06|TWO_SIDED|95.0|-7.7|-4.3|||Mixed Models Analysis|||||-4.3|-7.7|<0.000001
74007650|NCT04178967|147565664|SUPERIORITY||LS Mean Difference (Final Values)|-2.91||||0.241275|TWO_SIDED|95.0|-7.85|2.03|||ANCOVA|||||2.03|-7.85|0.241275
74007651|NCT04178967|147565665|SUPERIORITY||LS Mean Difference (Final Values)|-2.74||||0.000116|TWO_SIDED|95.0|-4.12|-1.36|||ANCOVA|||||-1.36|-4.12|0.000116
74007652|NCT04178967|147565666|SUPERIORITY||LS Mean Difference (Final Values)|-1.1||||0.645132|TWO_SIDED|95.0|-5.86|3.67|||ANCOVA|||||3.67|-5.86|0.645132
74007653|NCT04178967|147565667|SUPERIORITY||LS Mean Difference (Final Values)|-2.75||||3.1e-05|TWO_SIDED|95.0|-4.03|-1.47|||ANCOVA|||||-1.47|-4.03|0.000031
74007654|NCT04178967|147565668|SUPERIORITY||LS Mean Difference (Final Values)|0.0||||0.974417|TWO_SIDED|95.0|-0.27|0.26|||ANCOVA|||||0.26|-0.27|0.974417
74039239|NCT02505542|147632128|OTHER||LS Mean Difference vs Placebo|-0.4|STANDARD_ERROR_OF_MEAN|0.19|=|0.04|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||-0.02|-0.78|=0.040
74007655|NCT04178967|147565669|SUPERIORITY||LS Mean Difference (Final Values)|-4.2||||0.084769|TWO_SIDED|95.0|-9.1|0.6|||Mixed Models Analysis|||||0.6|-9.1|0.084769
74007656|NCT00628251|147565768|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.6604|TWO_SIDED|95.0|0.51|1.56||If the observed p-value for the combined olaparib groups is \<0.02 (1-sided) then the result will be regarded as statistically significant.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 or 400 mg bd (n=64) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.56|0.51|0.6604
74007657|NCT00628251|147565768|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.7794||95.0|0.48|1.74||An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.74|0.48|0.7794
74007658|NCT00628251|147565768|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.6604|TWO_SIDED|95.0|0.45|1.62||An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.62|0.45|0.6604
74007659|NCT00628251|147565769|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.27||||0.1291|TWO_SIDED|95.0|0.79|7.32||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).||7.32|0.79|0.1291
74007660|NCT00628251|147565769|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.3131|TWO_SIDED|95.0|0.55|7.01||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).||7.01|0.55|0.3131
73878592|NCT00141453|147296807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.79||95.0|0.75|1.24|||Regression, Cox|The covariates were urinary albumin:creatinine ratio and serum creatinine at baseline \& regions (Japan/Hong Kong) for the renal composite event rate.||We planned to collect 400 patients to detect 35% risk reduction for renal outcome in olmesartan group with 80% power at 2-sided .05 alpha level. The Cox regression model was applied to estimate the hazard ratios (HR)between treatment groups with 95% confidence intervals for the renal and cardiovascular composite event rate.||1.24|0.75|0.79
74007661|NCT00628251|147565769|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.69||||0.1079|TWO_SIDED|95.0|0.81|9.76|||Regression, Logistic|The analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).||9.76|0.81|0.1079
74007662|NCT00628251|147565775|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.5781|TWO_SIDED|95.0|0.41|1.7||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).||1.70|0.41|0.5781
74007663|NCT00628251|147565775|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.3417|TWO_SIDED|95.0|0.27|1.55||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).||1.55|0.27|0.3417
74039240|NCT02505542|147632128|OTHER||LS Mean Difference vs Placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.19|=|0.074|TWO_SIDED|95.0|-0.73|0.03|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.03|-0.73|=0.074
74039241|NCT01309841|147632157|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.38||||0.015|TWO_SIDED|95.0|1.062|1.795|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.795|1.062|0.015
74039242|NCT01309841|147632157|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.509||||0.001|TWO_SIDED|95.0|1.168|1.949|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.949|1.168|0.001
74039243|NCT01309841|147632158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.479||||0.028|TWO_SIDED|95.0|1.038|2.107||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.107|1.038|0.028
74039244|NCT01309841|147632158|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.691||||0.002|TWO_SIDED|95.0|1.205|2.373||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.373|1.205|0.002
74039245|NCT01309841|147632160|SUPERIORITY_OR_OTHER||LS mean difference|0.55|||<|0.001|TWO_SIDED|95.0|0.24|0.86|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.86|0.24|<0.001
74039246|NCT01309841|147632160|SUPERIORITY_OR_OTHER||Ls mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.51|1.13|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||1.13|0.51|<0.001
74039247|NCT01309841|147632161|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.176|TWO_SIDED|95.0|-0.23|0.04|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.04|-0.23|0.176
74039248|NCT01309841|147632161|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.008|TWO_SIDED|95.0|-0.32|-0.05|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.05|-0.32|0.008
74039249|NCT01309841|147632162|SUPERIORITY_OR_OTHER||LS mean difference|0.05||||0.564|TWO_SIDED|95.0|-0.12|0.23|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.23|-0.12|0.564
74039250|NCT01309841|147632162|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.042|TWO_SIDED|95.0|0.01|0.36|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.36|0.01|0.042
74039251|NCT01309841|147632163|SUPERIORITY_OR_OTHER||LS mean difference|3.87||||0.094|TWO_SIDED|95.0|-0.66|8.39|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||8.39|-0.66|0.094
74039252|NCT01309841|147632163|SUPERIORITY_OR_OTHER||LS mean difference|8.59|||<|0.001|TWO_SIDED|95.0|4.04|13.14|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||13.14|4.04|<0.001
74039253|NCT01309841|147632164|SUPERIORITY_OR_OTHER||LS mean difference|0.54||||0.011|TWO_SIDED|95.0|0.12|0.96|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.96|0.12|0.011
73878593|NCT00141453|147296808|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.039||95.0|0.43|0.98|||Regression, Cox|Covariates baseline urinary albumin:creatinine ratio, age and history of cardiovascular disease for cardiovascular composite event rate.||||0.98|0.43|0.039
74007664|NCT00628251|147565775|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.9877|TWO_SIDED|95.0|0.44|2.27||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).||2.27|0.44|0.9877
74007665|NCT00728481|147565786|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison between arms for a histologic response||||1.00
74007666|NCT00728481|147565791|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Fisher Exact|||Comparison between arms for a symptomatic response||||0.76
74007667|NCT01505010|147565798|SUPERIORITY||Mean Difference (Final Values)|22.4|STANDARD_ERROR_OF_MEAN|8.5||0.018|TWO_SIDED||||||Mixed Models Analysis|Adjusted for the baseline 24-h systolic blood pressure|Difference at 6 months in 24-h systolic blood pressure (control minus intervention)|We used mixed models to compare blood pressure changes between randomized groups at 6 months, while adjusting for the baseline blood pressure; statistical significance was a P-value less than 0.05 on two-sided tests.||||0.018
74091487|NCT03222583|147736865|NON_INFERIORITY|The percentage of GT2-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 95% if the LCB of the 2-sided 95% CI for the percentage was \> 89%.|Percentage of Participants with SVR12|97.8|||||TWO_SIDED|95.0|95.4|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||100.0|95.4|
74007668|NCT01505010|147565799|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|4.87||0.86|TWO_SIDED||||||t-test, 2 sided|||Difference between control and intervention group at 6 months||||0.86
74007669|NCT01505010|147565800|SUPERIORITY||Median Difference (Final Values)|1.7||||0.032|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcocon rank sum test||||0.032
74007670|NCT01505010|147565800|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.8||0.032|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.032
74007671|NCT00223678|147565847|SUPERIORITY_OR_OTHER|||||||0.849|||||||Log Rank|||||||0.849
74007672|NCT01624259|147565851|NON_INFERIORITY_OR_EQUIVALENCE|"Family-wise Type I error rate was controlled by applying a serial gatekeeping strategy.~This calculation assumed a 0 difference in HbA1c between the 1.5 mg LY2189265 1.5-mg arm and 1.8 mg liraglutide, 0.4% margin of noninferiority, common Standard Deviation (SD) of 1.3% for change from baseline in HbA1c, 0.05 two-sided significance level, and 25% dropout rate at 26 weeks."|LS Mean Difference|-0.06|||<|0.001|TWO_SIDED|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment).|Mixed Models Analysis|||To show noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide with 90% power, 222 completers (444 total) at 26 weeks were required. Noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide was demonstrated if the upper bound of the two-sided 95% Confidence Interval (CI) for the difference in mean change in HbA1c between the 1.5 mg LY2189265 arm and 1.8 mg liraglutide arm was below 0.4%.||0.07|-0.19|<0.001
74007673|NCT01624259|147565851|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.186|TWO_SIDED|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment)|Mixed Models Analysis|||Superiority analysis||0.07|-0.19|0.186
74007674|NCT01624259|147565852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|0.28||0.01|TWO_SIDED|95.0|0.17|1.26||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model at 26 weeks.||1.26|0.17|0.010
74007675|NCT01624259|147565853|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.1||0.013|TWO_SIDED|95.0|0.05|0.45||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.||0.45|0.05|0.013
74007676|NCT01624259|147565854|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|2.61||0.828|TWO_SIDED|95.0|-5.69|4.56||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.||4.56|-5.69|0.828
74007677|NCT01624259|147565855|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.25|STANDARD_ERROR_OF_MEAN|1.86||0.228|TWO_SIDED|95.0|-5.91|1.41||No adjustment for multiplicity.|Mixed Models Analysis|P-value from pairwise comparison of LS means at 26 weeks from REML-based MMRM.||||1.41|-5.91|0.228
74007678|NCT01624259|147565856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.322|TWO_SIDED|95.0|0.81|1.86||P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).|Regression, Logistic|No adjustment for multiplicity.||Treatment comparison for HbA1c levels ≤6.5%||1.86|0.81|0.322
74007679|NCT01624259|147565856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.925|TWO_SIDED|95.0|0.64|1.63||No adjustment for multiplicity.|Regression, Logistic|P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).||Treatment comparison for HbA1c levels \<7.0%.||1.63|0.64|0.925
74007680|NCT01624259|147565857|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|2.79||0.608|TWO_SIDED|95.0|-4.06|6.92|||ANCOVA|No adjustment for multiplicity.||||6.92|-4.06|0.608
74007681|NCT01920594|147566016|SUPERIORITY||Mean Difference (Final Values)|2228.14||||0.082|TWO_SIDED|95.0|-292.84|4749.11|||ANCOVA||The point estimate was calculated as least square (LS) mean difference (final values) of S-100B Protein \[test\] and S-100B Protein \[reference\].|||4749.11|-292.84|0.0820
74007682|NCT01920594|147566017|SUPERIORITY||Mean Difference (Final Values)|777.95||||0.1997|TWO_SIDED|95.0|-424.04|1979.94|||ANCOVA||The point estimate was calculated as LS mean difference (final values) of GFAP \[test\] and GFAP \[reference\].|||1979.94|-424.04|0.1997
74007683|NCT01920594|147566023|SUPERIORITY||Estimate of comparison (Ratio)|1.77||||0.153|TWO_SIDED|95.0|0.8|3.9|||ANOVA||The point estimate was calculated as Geometric mean ratio of S-100B\[test\] and S-100B\[reference\].|||3.90|0.80|0.1530
74007684|NCT01920594|147566024|SUPERIORITY||Estimate of comparison (Ratio)|3.13||||0.1377|TWO_SIDED|95.0|0.69|14.26|||ANOVA||The point estimate was calculated as Geometric mean ratio of GFAP\[test\] and GFAP\[reference\].|||14.26|0.69|0.1377
74007685|NCT01920594|147566025|SUPERIORITY||Mean Difference (Final Values)|34.56|||<|0.0001|TWO_SIDED|95.0|21.95|47.17|||ANCOVA||The point estimate was calculated as LS mean difference final values of Erythropoietin\[test\] and Erythropoietin\[reference\].|||47.17|21.95|<.0001
73878594|NCT04755816|147296834|OTHER|Estimates and confidence intervals are provided|Win Ratio|1.29|||||TWO_SIDED|95.0|1.08|1.54||||||"Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C. By the unmatched pairs win ratio method, each participant receiving the intervention will be compared to each participant not receiving the intervention. For each comparison, winners will be determined according to the hierarchy described above. The win ratio is the number winners divided by the number of losers associated with the intervention."||1.54|1.08|
73878595|NCT04755816|147296835|OTHER|Estimates and confidence intervals are provided|Win Ratio|1.29|||||TWO_SIDED|95.0|1.08|1.54||||||"Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in group A and B. By the unmatched pairs win ratio method, each participant receiving the intervention will be compared to each participant not receiving the intervention. For each comparison, winners will be determined according to the hierarchy described above. The win ratio is the number winners divided by the number of losers associated with the intervention."||1.54|1.08|
73957645|NCT00383188|147451046|SUPERIORITY||LSM Difference|-2.965|STANDARD_ERROR_OF_MEAN|3.915||0.4491|TWO_SIDED|95.0|-10.65|4.72|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.720|-10.65|0.4491
74091488|NCT03573505|147736871|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.112|TWO_SIDED|95.0|0.85|4.73|||Log Rank|||A cox proportional hazards model with terms for treatment (BG00011 vs. placebo) and randomization stratification factor is used. A stratified log-rank test is used to compare the 2 treatment groups using randomization stratus as the stratification factor. An HR (Hazard Ratio) \< 1 indicates lower risk of event for the BG00011 group where HR is based on Cox proportional hazard model with treatment (Placebo, BG00011) as the categorical covariate.||4.73|0.85|0.112
73957646|NCT00383188|147451046|SUPERIORITY||LSM Difference|-10.23|STANDARD_ERROR_OF_MEAN|3.85||0.0081|TWO_SIDED|95.0|-17.79|-2.671|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.671|-17.79|0.0081
73957647|NCT00383188|147451046|SUPERIORITY||LSM Difference|-9.291|STANDARD_ERROR_OF_MEAN|4.488||0.0388|TWO_SIDED|95.0|-18.1|-0.48|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.480|-18.10|0.0388
73957648|NCT00383188|147451046|SUPERIORITY||LSM Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.611||0.588|TWO_SIDED|95.0|-11.55|6.553|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.553|-11.55|0.5880
73957649|NCT00383188|147451046|SUPERIORITY||LSM Difference|3.78|STANDARD_ERROR_OF_MEAN|3.914||0.3345|TWO_SIDED|95.0|-3.904|11.464|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||11.464|-3.904|0.3345
73957650|NCT00383188|147451046|SUPERIORITY||LSM Difference|-9.019|STANDARD_ERROR_OF_MEAN|3.849||0.0194|TWO_SIDED|95.0|-16.58|-1.463|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.463|-16.58|0.0194
73957651|NCT00383188|147451046|SUPERIORITY||LSM Difference|-5.946|STANDARD_ERROR_OF_MEAN|4.488||0.1855|TWO_SIDED|95.0|-14.76|2.863|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.863|-14.76|0.1855
74007686|NCT01920594|147566026|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.2404|TWO_SIDED|95.0|-0.37|1.45|||ANCOVA||The point estimate was calculated as LS mean difference final values of Lactate Dehydrogenase\[test\] and Lactate Dehydrogenase\[reference\].|||1.45|-0.37|0.2404
74007687|NCT01920594|147566027|SUPERIORITY||Mean Difference (Final Values)|925.88||||0.0526|TWO_SIDED|95.0|-10.73|1862.49|||ANCOVA||The point estimate was calculated as LS mean difference final values of Tau Protein\[test\] and Tau Protein\[reference\].|||1862.49|-10.73|0.0526
73878596|NCT04755816|147296837|OTHER|Estimates and confidence intervals are provided|Hazard Ratio (HR)|1.096|||||TWO_SIDED|95.0|0.321|3.743||||||Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C.||3.743|0.321|
74007688|NCT01920594|147566028|SUPERIORITY||Mean Difference (Final Values)|4.11||||0.0893|TWO_SIDED|95.0|-0.65|8.87|||ANCOVA||The point estimate was calculated as LS mean difference final values of Neuron Specific Enolase\[test\] and Neuron Specific Enolase\[reference\].|||8.87|-0.65|0.0893
74007689|NCT01920594|147566033|SUPERIORITY||Ratio of geometric mean|1.84||||0.5012|TWO_SIDED|95.0|0.3|11.32|||ANOVA|||For Troponin I||11.32|0.30|0.5012
74007690|NCT01920594|147566033|SUPERIORITY||Ratio of geometric mean|0.75||||0.8053|TWO_SIDED|95.0|0.07|8.57|||ANOVA|||For Troponin T||8.57|0.07|0.8053
74007691|NCT02039726|147566045|OTHER||Hazard Ratio (HR)|0.758||||0.0185|TWO_SIDED|95.0|0.584|0.983|||P-value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy \[MEC or FLAG-IDA\], or low intensity chemotherapy \[LoDAC\]).||0.983|0.584|0.0185
74007692|NCT02039726|147566046|OTHER||Hazard Ratio (HR)|0.898||||0.2034|TWO_SIDED|95.0|0.697|1.157|||P value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy \[MEC or FLAG-IDA\], or low intensity chemotherapy \[LoDAC\]).||1.157|0.697|0.2034
73878597|NCT04755816|147296838|OTHER|Estimates and confidence intervals are provided|Slope|-15.37|||||TWO_SIDED|95.0|-37.5|6.76|||||"The total score for the MLHFQ ranges from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The change in MLHFQ is defined as MLHFQ at Week 12 minus MLHFQ at Week 0."|Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C. Simple linear regression models will be used to assess the outcome of change in MLHFQ over 12 weeks as a function of treatment group assignment. Beta coefficients and 95% confidence intervals will be reported.||6.76|-37.5|
73878598|NCT04755816|147296839|OTHER|Estimates and confidence intervals are provided|Hazard Ratio (HR)|0.556|||||TWO_SIDED|95.0|0.163|1.901||||||Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in treatment group A and B.||1.901|0.163|
73878599|NCT04755816|147296840|OTHER|Estimates and confidence intervals are provided|Slope|-12.98|||||TWO_SIDED|95.0|-33.67|7.72|||||"The total score for the MLHFQ ranges from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The change in MLHFQ is defined as MLHFQ at Week 12 minus MLHFQ at Week 0."|Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in treatment group A and B. Simple linear regression models will be used to assess the outcome of change in MLHFQ over 12 weeks as a function of treatment group assignment. Beta coefficients and 95% confidence intervals will be reported.||7.72|-33.67|
73957652|NCT00383188|147451046|SUPERIORITY||LSM Difference|-5.249|STANDARD_ERROR_OF_MEAN|4.611||0.2553|TWO_SIDED|95.0|-14.3|3.803|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.803|-14.30|0.2553
73957653|NCT00383188|147451046|SUPERIORITY||LSM Difference|-4.041|STANDARD_ERROR_OF_MEAN|3.912||0.302|TWO_SIDED|95.0|-11.72|3.639|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.639|-11.72|0.3020
73957654|NCT00383188|147451046|SUPERIORITY||LSM Difference|-10.27|STANDARD_ERROR_OF_MEAN|3.847||0.0078|TWO_SIDED|95.0|-17.82|-2.715|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.715|-17.82|0.0078
74007693|NCT00813319|147566058|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||This comparison is for participants in the Girls OnGuard/HPV Awareness condition compared to the General Health Promotion condition||||>.05
74007694|NCT00813319|147566059|SUPERIORITY_OR_OTHER||||||=|0.52|||||||Chi-squared|||||||=.52
74007695|NCT00813319|147566060|SUPERIORITY_OR_OTHER||||||=|0.12|||||||Chi-squared|Degrees of freedom = 2||This comparison is for total doses received (26 in Girls OnGuard/HPV Awareness condition compared to 17 in General Health Promotion condition)||||=.12
73878600|NCT00861705|147296853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.||||0.0018
73878601|NCT00861705|147296854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.||||0.0089
73957655|NCT00383188|147451046|SUPERIORITY||LSM Difference|-8.522|STANDARD_ERROR_OF_MEAN|4.486||0.0578|TWO_SIDED|95.0|-17.33|0.284|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||0.284|-17.33|0.0578
73878602|NCT00861705|147296855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0029|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||||||0.0029
73957656|NCT00383188|147451046|SUPERIORITY||LSM Difference|-7.042|STANDARD_ERROR_OF_MEAN|4.61||0.127|TWO_SIDED|95.0|-16.09|2.007|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.007|-16.09|0.1270
74007696|NCT02012296|147566061|SUPERIORITY|||||||0.83|||||||Log Rank|||||||0.83
74007697|NCT02012296|147566062|SUPERIORITY|||||||0.21|||||||Log Rank|||||||0.21
74007698|NCT02012296|147566065|SUPERIORITY|||||||0.0012|||||||t-test, 2 sided|||||||0.0012
73957657|NCT00383188|147451046|SUPERIORITY||LSM Difference|5.927|STANDARD_ERROR_OF_MEAN|4.051||0.1438|TWO_SIDED|95.0|-2.023|13.877|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||13.877|-2.023|0.1438
74007699|NCT02012296|147566066|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74007700|NCT02012296|147566067|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
74007701|NCT01448213|147566068|SUPERIORITY_OR_OTHER|||||||0.17|||||||Log Rank|||||||0.17
73957658|NCT00383188|147451046|SUPERIORITY||LSM Difference|-1.979|STANDARD_ERROR_OF_MEAN|3.931||0.6149|TWO_SIDED|95.0|-9.696|5.738|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.738|-9.696|0.6149
74007702|NCT01448213|147566069|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Log Rank|||||||0.0005
74007703|NCT00892177|147566083|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|100.0|||||TWO_SIDED|||||||||||||
74007704|NCT00892177|147566084|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.1||||0.22|TWO_SIDED|95.0|-0.052|0.262|||Chi-squared, Corrected||Difference in proportion|||0.262|-0.052|0.22
73878603|NCT00861705|147296856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||||||0.057
73878604|NCT00861705|147296860|SUPERIORITY||Cox Proportional Hazard|1.19|||||TWO_SIDED|95.0|0.67|2.1||||||||2.10|0.67|
74091489|NCT00158600|147736957|SUPERIORITY_OR_OTHER||Difference|28.12||||0.0347||95.0|2.07|54.17||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in distance walked from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||54.17|2.07|0.0347
74091490|NCT00158600|147736958|SUPERIORITY_OR_OTHER||Difference|3.4||||0.0055||95.0|1.03|5.77||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in % predicted FVC from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||5.77|1.03|0.0055
74091491|NCT00158600|147736959|SUPERIORITY_OR_OTHER||Difference|3.18||||0.1093||95.0|-0.73|7.08||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in QMT from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||7.08|-0.73|0.1093
74091492|NCT00158600|147736960|SUPERIORITY_OR_OTHER||Difference|-0.37||||0.8333||95.0|-3.83|3.09||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in PCS from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||3.09|-3.83|0.8333
74091493|NCT02737332|147736964|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio of treatments|1.019||||0.4879|TWO_SIDED|90.0|0.964|1.077||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.077|0.964|0.4879
73957659|NCT00383188|147451046|SUPERIORITY||LSM Difference|6.545|STANDARD_ERROR_OF_MEAN|4.664||0.1609|TWO_SIDED|95.0|-2.61|15.7|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||15.700|-2.610|0.1609
73957660|NCT00383188|147451046|SUPERIORITY||LSM Difference|6.579|STANDARD_ERROR_OF_MEAN|4.78||0.1691|TWO_SIDED|95.0|-2.804|15.961|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||15.961|-2.804|0.1691
74091494|NCT02737332|147736965|OTHER|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.994||||0.3642|TWO_SIDED|90.0|0.0451|2.192||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||2.192|0.0451|0.3642
74091495|NCT02737332|147736965|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.81||||0.4069|TWO_SIDED|90.0|0.338|1.939||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.939|0.338|0.4069
73878605|NCT00861705|147296860|SUPERIORITY||Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.82|2.47||||||||2.47|0.82|
73878606|NCT00861705|147296860|SUPERIORITY||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.49|1.37||||||||1.37|0.49|
73878607|NCT00861705|147296861|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.66|1.75||||||||1.75|0.66|
73878608|NCT00861705|147296861|SUPERIORITY||Cox Proportional Hazard|1.2|||||TWO_SIDED|95.0|0.74|1.92||||||||1.92|0.74|
73878609|NCT00861705|147296861|SUPERIORITY||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.49|1.37||||||||1.37|0.49|
73878610|NCT00861705|147296862|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.66|2.03||||||||2.03|0.66|
73878611|NCT00861705|147296862|SUPERIORITY||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.72|2.16||||||||2.16|0.72|
73878612|NCT00861705|147296862|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.53|1.7||||||||1.70|0.53|
74007705|NCT00892177|147566086|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.61|1.4|||Kaplan Meier|||||1.4|0.61|0.7
74007706|NCT00892177|147566087|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.14||||0.52|TWO_SIDED|95.0|0.76|1.7|||Kaplan Meier|||||1.7|0.76|0.52
73878613|NCT04678115|147296900|OTHER|Power Calculation: Sample size was estimated based on the treatment condition (three-level factor) effect size on the spontaneous blink IPF measurements (0.55) after eight participants had completed the crossover using one-way analysis of variance power calculation. This led to a sample size of 12 participants with power of 0.80 and type II error of alpha 0.05. To account for possible attrition, 16 were enrolled, with 15 completing the crossover.|||||<|0.001||||||a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Linear mixed-effects regression was used to determine the effect of treatment condition on the spontaneous blink and resting state open IPF, with participant as random intercept. Covariates of age, gender, blink sequence, and crossover order were investigated alone, and significant (P \< 0.05) covariates were included in the final model, from which the estimated marginal means and their 95% confidence interval were reported. Hypothesis: MLP allows a more complete spontaneous blink.||||<0.001
73878614|NCT04678115|147296901|OTHER|||||||0.001|||||||Mixed Models Analysis|||Hypothesis was that both devices (MLP and KFTS) would open the eye equally well, and that both would be better than sham treatment.||||0.001
74007707|NCT00892177|147566088|SUPERIORITY||Mean Difference (Final Values)|-0.223||||0.96|TWO_SIDED||||||Mixed Models Analysis||The estimate is the net difference between Arm A and Arm B total score using information from all cycles. A negative value means that Arm A has a lower quality of life and a positive value means Arm A has a higher reported quality of life.|||||0.96
73957661|NCT00383188|147451047|SUPERIORITY||LSM Difference|-1.409|STANDARD_ERROR_OF_MEAN|3.341||0.6733|TWO_SIDED|95.0|-7.967|5.149|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.149|-7.967|0.6733
73957662|NCT00383188|147451047|SUPERIORITY||LSM Difference|-5.629|STANDARD_ERROR_OF_MEAN|3.274||0.0859|TWO_SIDED|95.0|-12.05|0.797|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||0.797|-12.05|0.0859
73957663|NCT00383188|147451047|SUPERIORITY||LSM Difference|-9.718|STANDARD_ERROR_OF_MEAN|3.8||0.0107|TWO_SIDED|95.0|-17.18|-2.259|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.259|-17.18|0.0107
74007708|NCT00892177|147566089|SUPERIORITY|||||||0.6325|||||||Fisher Exact|||||||0.6325
74039254|NCT01309841|147632164|SUPERIORITY_OR_OTHER||LS mean difference|0.99|||<|0.001|TWO_SIDED|95.0|0.57|1.41|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||1.41|0.57|<0.001
73878615|NCT04678115|147296902|OTHER|||||||0.001|||||||test of proportionality|||A test of proportionality was performed to determine the effect of the three treatments on the probability of the eyelid not fully closing.||||0.001
73878616|NCT03100149|147296929|SUPERIORITY||Difference in Adjusted Means|-2.02|STANDARD_ERROR_OF_MEAN|1.71||0.2385|TWO_SIDED|80.0|-4.21|0.18|||Mixed Models Analysis|||||0.18|-4.21|0.2385
73957664|NCT00383188|147451047|SUPERIORITY||LSM Difference|-3.695|STANDARD_ERROR_OF_MEAN|3.921||0.3463|TWO_SIDED|95.0|-11.39|4.002|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.002|-11.39|0.3463
73957665|NCT00383188|147451047|SUPERIORITY||LSM Difference|-5.185|STANDARD_ERROR_OF_MEAN|3.312||0.1178|TWO_SIDED|95.0|-11.69|1.316|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||1.316|-11.69|0.1178
73957666|NCT00383188|147451047|SUPERIORITY||LSM Difference|-7.107|STANDARD_ERROR_OF_MEAN|3.245||0.0288|TWO_SIDED|95.0|-13.48|-0.737|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.737|-13.48|0.0288
73957667|NCT00383188|147451047|SUPERIORITY||LSM Difference|-9.743|STANDARD_ERROR_OF_MEAN|3.772||0.01|TWO_SIDED|95.0|-17.15|-2.34|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.340|-17.15|0.0100
73957668|NCT00383188|147451047|SUPERIORITY||LSM Difference|-5.468|STANDARD_ERROR_OF_MEAN|3.888||0.16|TWO_SIDED|95.0|-13.1|2.164|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.164|-13.10|0.1600
73957669|NCT00383188|147451047|SUPERIORITY||LSM Difference|-0.4|STANDARD_ERROR_OF_MEAN|3.312||0.904|TWO_SIDED|95.0|-6.9|6.101|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.101|-6.900|0.9040
73957670|NCT00383188|147451047|SUPERIORITY||LSM Difference|-6.895|STANDARD_ERROR_OF_MEAN|3.245||0.0339|TWO_SIDED|95.0|-13.26|-0.524|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.524|-13.26|0.0339
74007709|NCT02645760|147566090|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.26 points in mean 11-point NRS pain score between core stabilization exercise and conventional treatment from baseline to week 7.||||<0.001
74007710|NCT02645760|147566091|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.68 points in mean disability score (RMDQ score) between core stabilization exercise and conventional treatment from baseline to week 7.||||0.009
74007711|NCT02645760|147566092|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.79 centimeter in mean range of motion between core stabilization exercise and conventional treatment from baseline to week 7.||||0.013
74007712|NCT02645760|147566093|SUPERIORITY_OR_OTHER|||||||0.012|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.30 centimeter in mean repositioning error between core stabilization exercise and conventional treatment from baseline to week 7.||||0.012
73957671|NCT00383188|147451047|SUPERIORITY||LSM Difference|-8.891|STANDARD_ERROR_OF_MEAN|3.771||0.0186|TWO_SIDED|95.0|-16.29|-1.488|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.488|-16.29|0.0186
73957672|NCT00383188|147451047|SUPERIORITY||LSM Difference|-2.714|STANDARD_ERROR_OF_MEAN|3.888||0.4854|TWO_SIDED|95.0|-10.35|4.918|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.918|-10.35|0.4854
73957673|NCT00383188|147451047|SUPERIORITY||LSM Difference|-1.387|STANDARD_ERROR_OF_MEAN|3.311||0.6753|TWO_SIDED|95.0|-7.886|5.112|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.112|-7.886|0.6753
73957674|NCT00383188|147451047|SUPERIORITY||LSM Difference|-11.09|STANDARD_ERROR_OF_MEAN|3.244||0.0007|TWO_SIDED|95.0|-17.46|-4.724|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-4.724|-17.46|0.0007
74007713|NCT02267603|147566094|OTHER|The null hypothesis will be rejected if 3 or more responses are observed in 24 patients. This design yields a type I error rate of 0.10 and power of 0.90 when the true response rate is 25%. Progression-free survival (PFS) at 16 months will be estimated by Kaplan-Meier method. Unless otherwise stated, all statistical tests will be conducted at the α=0.05 (1-sided) level.||||||||||||||||The protocol was designed w/ a standard Simon 2 stage design. Null hypothesis that true response rate is 5% was tested against a 1-sided alternative. In stage 1, 9 patients were accrued. If no responses in these 9 patients, study was to stop. Otherwise,15 more patients were to be accrued for a total of 24 patients. Study was amended to increase number of patients to 50, following discussion w/ pharmaceutical collaborator and FDA.|ORR will be estimated as the # of responders as a % of the # of eligible participants who received at least 1 dose of treatment. If a substantial amount of primary endpoint data are missing (at least 1 value missing from more than 20% of participants), using nonparametric estimation to estimate the ORR requires the missing completely at random assumption may give misleading results. In this case, analyses of the primary endpoint will be performed using parametric generalized linear models fit by maximum likelihood. These methods provide unbiased estimation and inferences under the parametric modeling assumptions and the assumption that the missing data are missing at random (MAR). MAR assumes that the probability of an observation being missing may depend upon the observed responses and upon observed covariates. A generalized linear model for the ORR will use a binomial error distribution. The model will include as covariates all available baseline predictors of the missing outcomes.|||
74007714|NCT00006392|147566129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||<|0.01|TWO_SIDED|99.0|0.95|1.35||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.||1.35|0.95|< .01
74007715|NCT00006392|147566129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||<|0.01|TWO_SIDED|99.0|0.87|1.24||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.||1.24|0.87|< .01
74007716|NCT00006392|147566129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||<|0.01||99.0|0.88|1.25||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 99% power to detect a 44% reduction in prostate cancer for combination vs. Placebo.||1.25|.88|< .01
74007717|NCT00006392|147566130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||>|0.05||99.0|0.64|1.55||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.55|.64|> .05
74007718|NCT00006392|147566130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||>|0.01|TWO_SIDED|99.0|0.73|1.72||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.72|0.73|> .01
74007719|NCT00006392|147566130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|||>|0.01|TWO_SIDED|99.0|0.9|1.16||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.16|0.90|>.01
74039255|NCT01309841|147632166|SUPERIORITY_OR_OTHER||LS mean difference|-0.08||||0.273|TWO_SIDED|95.0|-0.21|0.06||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.06|-0.21|0.273
74039256|NCT01309841|147632166|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.089|TWO_SIDED|95.0|-0.26|0.02||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.02|-0.26|0.089
73957675|NCT00383188|147451047|SUPERIORITY||LSM Difference|-9.535|STANDARD_ERROR_OF_MEAN|3.771||0.0116|TWO_SIDED|95.0|-16.94|-2.134|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.134|-16.94|0.0116
74039257|NCT01309841|147632166|SUPERIORITY_OR_OTHER||Slope|0.02||||0.849|TWO_SIDED|95.0|-0.14|0.17||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.17|-0.14|0.849
74039258|NCT01309841|147632166|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.749|TWO_SIDED|95.0|-0.18|0.13||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.13|-0.18|0.749
74039259|NCT01309841|147632166|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.062|TWO_SIDED|95.0|-0.26|0.01||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.26|0.062
74039260|NCT01309841|147632166|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.003|TWO_SIDED|95.0|-0.35|-0.07||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.07|-0.35|0.003
74039261|NCT01309841|147632166|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.202|TWO_SIDED|95.0|-0.29|0.06||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.06|-0.29|0.202
74039262|NCT01309841|147632166|SUPERIORITY_OR_OTHER||LS mean difference|-0.16||||0.072|TWO_SIDED|95.0|-0.34|0.01||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.34|0.072
74039263|NCT01309841|147632167|SUPERIORITY_OR_OTHER||LS mean difference|-0.02||||0.831|TWO_SIDED|95.0|-0.25|0.2|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.||0.20|-0.25|0.831
74039264|NCT01309841|147632167|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.141|TWO_SIDED|95.0|-0.41|0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.||0.06|-0.41|0.141
74039265|NCT00138424|147632195|SUPERIORITY_OR_OTHER||Spearman Correlation|0.24||||0.57|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter||||0.57
74091496|NCT02737332|147736965|EQUIVALENCE|One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|Geometric mean ratio|1.039||||0.7186|TWO_SIDED|90.0|0.412|2.617||The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||2.617|0.412|0.7186
74091497|NCT02737332|147736966|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73957676|NCT00383188|147451047|SUPERIORITY||LSM Difference|-8.322|STANDARD_ERROR_OF_MEAN|3.888||0.0326|TWO_SIDED|95.0|-15.95|-0.691|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.691|-15.95|0.0326
74007720|NCT00006392|147566131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|||>|0.05|TWO_SIDED|99.0|0.69|1.73||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||1.73|0.69|> .05
74007721|NCT00006392|147566131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||>|0.05|TWO_SIDED|99.0|0.66|1.67||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||1.67|0.66|> .05
73957677|NCT00383188|147451047|SUPERIORITY||LSM Difference|-3.624|STANDARD_ERROR_OF_MEAN|3.309||0.2738|TWO_SIDED|95.0|-10.12|2.872|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.872|-10.12|0.2738
74007722|NCT00006392|147566131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28|||>|0.05|TWO_SIDED|99.0|0.82|2.0||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||2.00|0.82|> .05
74091498|NCT02737332|147736967|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.999||||0.9211|TWO_SIDED|90.0|0.98|1.018||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.||ANOVA-model-based Least-Square Mean|1.018|0.980|0.9211
74091499|NCT02737332|147736967|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|1.168||||0.3037|TWO_SIDED|90.0|0.9|1.515||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.515|0.900|0.3037
74091500|NCT02737332|147736967|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.0||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.000|1.000|
74091501|NCT02737332|147736968|OTHER|||||||0.5495|||||||ANOVA|||||||0.5495
74091502|NCT02737332|147736968|OTHER|||||||0.2616|||||||ANOVA|||||||0.2616
74091503|NCT02737332|147736968|OTHER|||||||0.3632|||||||ANOVA|||||||0.3632
74091504|NCT02737332|147736968|OTHER|||||||0.3393|||||||ANOVA|||||||0.3393
73878617|NCT03100149|147296929|SUPERIORITY||Difference in Adjusted Means|-0.62|STANDARD_ERROR_OF_MEAN|1.71||0.7169|TWO_SIDED|80.0|-2.82|1.58|||Mixed Models Analysis|||||1.58|-2.82|0.7169
74007723|NCT00006392|147566132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03|||>|0.05|TWO_SIDED|99.0|0.91|1.17||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.17|0.91|> .05
74007724|NCT00006392|147566132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|||>|0.05|TWO_SIDED|99.0|0.89|1.15||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.15|0.89|> .05
74007725|NCT00006392|147566132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02|||>|0.05||99.0|0.9|1.16||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.16|0.90|> .05
74007726|NCT00006392|147566133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||>|0.05||99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo is the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.13|0.77|> .05
74007727|NCT00006392|147566133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||>|0.05|TWO_SIDED|99.0|0.82|1.19||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.19|0.82|> .05
74007728|NCT00006392|147566133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||>|0.05|TWO_SIDED|99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox|||Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.13|0.77|> .05
74091505|NCT02737332|147736972|OTHER|||||||0.1917|||||||ANOVA|||||||0.1917
74091506|NCT02618408|147736978|SUPERIORITY||Median Difference (Net)|-7.08||||0.0916|TWO_SIDED|95.0|-15.38|1.22|||Wilcoxon (Mann-Whitney)|||||1.22|-15.38|0.0916
74091507|NCT02618408|147736978|SUPERIORITY||Median Difference (Net)|-1.76||||0.7136|TWO_SIDED|95.0|-11.78|8.27|||Wilcoxon (Mann-Whitney)|||Based on the results of a prespecified interim analysis, the enrollment of the low dose SPN-810 arm was halted, and this treatment arm was dropped. Accordingly, all analysis of primary and secondary endpoints focused on the comparison of SPN-810 high dose and placebo||8.27|-11.78|0.7136
74091508|NCT02618408|147736979|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.108||0.0238|TWO_SIDED|95.0|-0.46|-0.03|||Mixed Models Analysis|||||-0.03|-0.46|0.0238
74091509|NCT02618408|147736979|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.123||0.0683|TWO_SIDED|95.0|-0.47|0.02|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.02|-0.47|0.0683
74091510|NCT02618408|147736979|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.136||0.0742|TWO_SIDED|95.0|-0.51|0.02|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.02|-0.51|0.0742
74007729|NCT00006392|147566134|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||>|0.05|TWO_SIDED|99.0|0.88|1.09||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.09|0.88|> .05
74091511|NCT02618408|147736980|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.105||0.3713|TWO_SIDED|95.0|-0.3|0.11|||Mixed Models Analysis|||||0.11|-0.30|0.3713
74091512|NCT02618408|147736980|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.131||0.1367|TWO_SIDED|95.0|-0.45|0.06|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.06|-0.45|0.1367
73957678|NCT00383188|147451047|SUPERIORITY||LSM Difference|-9.778|STANDARD_ERROR_OF_MEAN|3.243||0.0026|TWO_SIDED|95.0|-16.14|-3.412|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-3.412|-16.14|0.0026
73957679|NCT00383188|147451047|SUPERIORITY||LSM Difference|-9.339|STANDARD_ERROR_OF_MEAN|3.769||0.0134|TWO_SIDED|95.0|-16.74|-1.941|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.941|-16.74|0.0134
73957680|NCT00383188|147451047|SUPERIORITY||LSM Difference|-5.528|STANDARD_ERROR_OF_MEAN|3.886||0.1553|TWO_SIDED|95.0|-13.16|2.101|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.101|-13.16|0.1553
73957681|NCT00383188|147451047|SUPERIORITY||LSM Difference|-0.118|STANDARD_ERROR_OF_MEAN|3.444||0.9726|TWO_SIDED|95.0|-6.878|6.641|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.641|-6.878|0.9726
73957682|NCT00383188|147451047|SUPERIORITY||LSM Difference|1.409|STANDARD_ERROR_OF_MEAN|3.321||0.6714|TWO_SIDED|95.0|-5.109|7.928|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||7.928|-5.109|0.6714
73957683|NCT00383188|147451047|SUPERIORITY||LSM Difference|0.646|STANDARD_ERROR_OF_MEAN|3.925||0.8693|TWO_SIDED|95.0|-7.058|8.351|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||8.351|-7.058|0.8693
73957684|NCT00383188|147451047|SUPERIORITY||LSM Difference|1.289|STANDARD_ERROR_OF_MEAN|4.035||0.7495|TWO_SIDED|95.0|-6.631|9.208|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||9.208|-6.631|0.7495
73957685|NCT00383188|147451048|SUPERIORITY||LSM Difference|-8.983|STANDARD_ERROR_OF_MEAN|4.469||0.0447|TWO_SIDED|95.0|-17.75|-0.214|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-0.214|-17.75|0.0447
73957686|NCT00383188|147451048|SUPERIORITY||LSM Difference|-15.12|STANDARD_ERROR_OF_MEAN|4.345||0.0005|TWO_SIDED|95.0|-23.65|-6.596|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-6.596|-23.65|0.0005
73957687|NCT00383188|147451048|SUPERIORITY||LSM Difference|-17.07|STANDARD_ERROR_OF_MEAN|4.981||0.0006|TWO_SIDED|95.0|-26.84|-7.296|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-7.296|-26.84|0.0006
73957688|NCT00383188|147451048|SUPERIORITY||LSM Difference|-16.26|STANDARD_ERROR_OF_MEAN|5.218||0.0019|TWO_SIDED|95.0|-26.49|-6.018|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-6.018|-26.49|0.0019
73957689|NCT00383188|147451048|SUPERIORITY||LSM Difference|-3.841|STANDARD_ERROR_OF_MEAN|4.366||0.3792|TWO_SIDED|95.0|-12.41|4.726|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||4.726|-12.41|0.3792
73957690|NCT00383188|147451048|SUPERIORITY||LSM Difference|-9.345|STANDARD_ERROR_OF_MEAN|4.237||0.0276|TWO_SIDED|95.0|-17.66|-1.031|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-1.031|-17.66|0.0276
73957691|NCT00383188|147451048|SUPERIORITY||LSM Difference|-12.69|STANDARD_ERROR_OF_MEAN|4.873||0.0093|TWO_SIDED|95.0|-22.25|-3.128|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-3.128|-22.25|0.0093
73957692|NCT00383188|147451048|SUPERIORITY||LSM Difference|-9.599|STANDARD_ERROR_OF_MEAN|5.03||0.0566|TWO_SIDED|95.0|-19.47|0.271|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||0.271|-19.47|0.0566
74007730|NCT00006392|147566134|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||>|0.05|TWO_SIDED|99.0|0.92|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.13|0.92|> .05
74007731|NCT00006392|147566134|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||>|0.05|TWO_SIDED|99.0|0.89|1.1||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.10|0.89|> .05
74007732|NCT01186796|147566135|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
74039266|NCT00138424|147632195|SUPERIORITY_OR_OTHER||Spearman Correlation|0.26||||0.53|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter||||0.53
74039267|NCT00138424|147632195|SUPERIORITY_OR_OTHER||Spearman Correlation|-0.3||||0.62|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter||||0.62
73878618|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.165||0.6116|TWO_SIDED|80.0|-0.3|0.13||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IA||0.13|-0.30|0.6116
73957693|NCT00383188|147451048|SUPERIORITY||LSM Difference|0.803|STANDARD_ERROR_OF_MEAN|4.366||0.854|TWO_SIDED|95.0|-7.764|9.37|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||9.370|-7.764|0.8540
73957694|NCT00383188|147451048|SUPERIORITY||LSM Difference|-2.364|STANDARD_ERROR_OF_MEAN|4.237||0.577|TWO_SIDED|95.0|-10.68|5.95|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||5.950|-10.68|0.5770
74007733|NCT01186796|147566136|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
74007734|NCT01186796|147566137|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||"Unit of mass secreted per burst is in ug/L. An automated deconvolution method was used and mathematically verified by direct statistical proof and empirically validated using hypothalamopituitary sampling and a simulated pulsatile time series."|ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
74007735|NCT01186796|147566138|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
74007736|NCT01186796|147566139|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
74007737|NCT01958788|147566142|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.06|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
74039268|NCT00138424|147632195|SUPERIORITY_OR_OTHER||Spearman Correlation|0.8||||0.1|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter||||0.10
74039269|NCT00138424|147632196|SUPERIORITY_OR_OTHER||Spearman Correlation|0.07||||0.87|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter||||0.87
74007738|NCT01958788|147566142|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.34|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
74007739|NCT01958788|147566142|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.37|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
74039270|NCT00138424|147632196|SUPERIORITY_OR_OTHER||Spearman Correlation|0.31||||0.46|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter||||0.46
74039271|NCT00138424|147632196|SUPERIORITY_OR_OTHER||Spearman Correlation|-0.41||||0.49|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter||||0.49
74039272|NCT00138424|147632196|SUPERIORITY_OR_OTHER||Spearman Correlation|0.87||||0.05|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter||||0.05
74039273|NCT00138424|147632196|SUPERIORITY_OR_OTHER||Spearman Correlation|0.12||||0.78|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter||||0.78
74039274|NCT00138424|147632196|SUPERIORITY_OR_OTHER||Spearman Correlation|0.52||||0.18|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter||||0.18
74091513|NCT02618408|147736980|SUPERIORITY||Median Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.146||0.1729|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.09|-0.49|0.1729
73878619|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|0.08|STANDARD_ERROR_OF_MEAN|0.165||0.6188|TWO_SIDED|80.0|-0.13|0.3||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IA||0.30|-0.13|0.6188
73878620|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-0.04|STANDARD_ERROR_OF_MEAN|0.345||0.9062|TWO_SIDED|80.0|-0.48|0.4||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IB||0.40|-0.48|0.9062
74007740|NCT01958788|147566143|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.32|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
74039275|NCT00138424|147632196|SUPERIORITY_OR_OTHER||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter||||0.75
74039276|NCT00138424|147632196|SUPERIORITY_OR_OTHER||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter||||0.75
74039277|NCT01056341|147632242|SUPERIORITY_OR_OTHER||||||<|0.0001||||||"P-value not adjusted for multiplicity. An Independent Committee conducted this analysis to determine the most efficacious of all arms with a good safety profile.~P-value linked to the 3 mg/kg/day 6 months selected arm ."|One-sided Z-tests|One-sided Z-tests for proportions (contrasts tests on placebo) with pooled variance||The interim analysis was carried out after the first 188 patients have completed their W24 visit or been withdrawn prematurely from study therapy. For each propranolol arm, individual hypotheses H0,i: θi≤0||||< 0.0001
74007741|NCT01958788|147566143|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.29|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
74007742|NCT01958788|147566143|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.15|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
74007743|NCT01958788|147566144|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.72|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment follow-up||||
74007744|NCT01958788|147566144|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.66|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
74007745|NCT01958788|147566144|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.07|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
74007746|NCT01958788|147566145|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.13|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
74007747|NCT01958788|147566145|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.06|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
74007748|NCT01958788|147566145|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.18|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
74007749|NCT01958788|147566146|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.41|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
74007750|NCT01958788|147566146|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.65|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
74007751|NCT01958788|147566146|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.7|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
74007752|NCT01958788|147566147|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.64|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
74007753|NCT01958788|147566147|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.47|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
74007754|NCT01958788|147566147|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.56|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
74007755|NCT01958788|147566148|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.08|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
74007756|NCT01958788|147566148|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.15|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
74007757|NCT01958788|147566148|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.55|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
74007758|NCT03933397|147566150|SUPERIORITY|||||||0.909|||||||Regression, Linear|||||||0.909
74007759|NCT01910116|147566155|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Assuming that an improvement in AUSCAN pain score of \>10 is clinically meaningful, and assuming an alpha level of 0.05 (two-tailed), a power of 0.80, and a dropout rate of 20%, the sample size calculation revealed that 220 patients should be enrolled.||||0.014
74007760|NCT01910116|147566156|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.011
74007761|NCT01910116|147566157|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.053
74007762|NCT01910116|147566158|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.014
74007763|NCT01910116|147566159|SUPERIORITY_OR_OTHER|||||||0.728|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.728
74007764|NCT01910116|147566160|SUPERIORITY_OR_OTHER|||||||0.229|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.229
74091514|NCT02618408|147736981|SUPERIORITY||Mean Difference (Net)|2.15|STANDARD_ERROR_OF_MEAN|1.456||0.1407|TWO_SIDED|95.0|-0.72|5.02|||ANCOVA|||This analysis pertains to the physical functioning summary score at Visit 6.||5.02|-0.72|0.1407
74007765|NCT01910116|147566161|SUPERIORITY_OR_OTHER|||||||0.194|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.194
74007766|NCT01910116|147566162|SUPERIORITY_OR_OTHER|||||||0.347|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.347
74007767|NCT01910116|147566163|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.122
74007768|NCT01910116|147566164|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.097
74007769|NCT01910116|147566166|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.050
74007770|NCT01910116|147566167|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.031
74007771|NCT01910116|147566168|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.021
74007772|NCT01910116|147566169|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.049
74007773|NCT01910116|147566170|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.221
74007774|NCT01910116|147566171|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.174
74007775|NCT01910116|147566172|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.124
73878621|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|0.02|STANDARD_ERROR_OF_MEAN|0.347||0.9621|TWO_SIDED|80.0|-0.43|0.46||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IB||0.46|-0.43|0.9621
73957695|NCT00383188|147451048|SUPERIORITY||LSM Difference|-6.33|STANDARD_ERROR_OF_MEAN|4.873||0.1942|TWO_SIDED|95.0|-15.89|3.232|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||3.232|-15.89|0.1942
74091515|NCT02618408|147736981|SUPERIORITY||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.898||0.5586|TWO_SIDED|95.0|-2.29|1.24|||ANCOVA|||This analysis pertains to the psychosocial health summary score at Visit 6||1.24|-2.29|0.5586
74091516|NCT02618408|147736982|SUPERIORITY||Median Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|2.07||0.7637|TWO_SIDED|95.0|-4.7|3.45|||ANCOVA|||This analysis pertains to the Total Stress summary score Visit 6.||3.45|-4.70|0.7637
74091517|NCT02618408|147736982|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.895||0.8365|TWO_SIDED|95.0|-1.95|1.58|||ANCOVA|||This analysis pertains to the Parental Distress Domain score at Visit 6.||1.58|-1.95|0.8365
74091518|NCT02618408|147736982|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_ERROR_OF_MEAN|0.829||0.4606|TWO_SIDED|95.0|-2.24|1.02|||ANCOVA|||This analysis pertains to the Parent-Child Dysfunctional Interaction score at Visit 6.||1.02|-2.24|0.4606
74091519|NCT02618408|147736982|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.837||0.8222|TWO_SIDED|95.0|-1.84|1.46|||ANCOVA|||This analysis pertains to the Difficult Child Domain score Visit 6.||1.46|-1.84|0.8222
73957696|NCT00383188|147451048|SUPERIORITY||LSM Difference|1.494|STANDARD_ERROR_OF_MEAN|5.03||0.7665|TWO_SIDED|95.0|-8.376|11.364|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.364|-8.376|0.7665
73957697|NCT00383188|147451048|SUPERIORITY||LSM Difference|3.291|STANDARD_ERROR_OF_MEAN|4.366||0.4512|TWO_SIDED|95.0|-5.276|11.858|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.858|-5.276|0.4512
73957698|NCT00383188|147451048|SUPERIORITY||LSM Difference|-0.095|STANDARD_ERROR_OF_MEAN|4.237||0.9822|TWO_SIDED|95.0|-8.409|8.22|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||8.220|-8.409|0.9822
73957699|NCT00383188|147451048|SUPERIORITY||LSM Difference|-5.148|STANDARD_ERROR_OF_MEAN|4.873||0.291|TWO_SIDED|95.0|-14.71|4.414|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||4.414|-14.71|0.2910
73957700|NCT00383188|147451048|SUPERIORITY||LSM Difference|2.828|STANDARD_ERROR_OF_MEAN|5.03||0.5741|TWO_SIDED|95.0|-7.042|12.698|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||12.698|-7.042|0.5741
74091520|NCT02618408|147736983|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.121||0.1031|TWO_SIDED|95.0|-0.43|0.04|||Mixed Models Analysis|||||0.04|-0.43|0.1031
73957701|NCT00383188|147451048|SUPERIORITY||LSM Difference|3.107|STANDARD_ERROR_OF_MEAN|4.366||0.4768|TWO_SIDED|95.0|-5.46|11.674|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.674|-5.460|0.4768
74091521|NCT02618408|147736983|SUPERIORITY|This analysis pertains to Visit 5|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.132||0.025|TWO_SIDED|95.0|-0.56|-0.04|||Mixed Models Analysis|||||-0.04|-0.56|0.0250
73878622|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-0.19|STANDARD_ERROR_OF_MEAN|0.411||0.651|TWO_SIDED|80.0|-0.71|0.34||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part I Total||0.34|-0.71|0.6510
73957702|NCT00383188|147451048|SUPERIORITY||LSM Difference|-2.256|STANDARD_ERROR_OF_MEAN|4.237||0.5945|TWO_SIDED|95.0|-10.57|6.058|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||6.058|-10.57|0.5945
73878623|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|0.12|STANDARD_ERROR_OF_MEAN|0.413||0.7709|TWO_SIDED|80.0|-0.41|0.65||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part I Total||0.65|-0.41|0.7709
73957703|NCT00383188|147451048|SUPERIORITY||LSM Difference|0.609|STANDARD_ERROR_OF_MEAN|4.873||0.9006|TWO_SIDED|95.0|-8.953|10.171|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||10.171|-8.953|0.9006
73957704|NCT00383188|147451048|SUPERIORITY||LSM Difference|9.224|STANDARD_ERROR_OF_MEAN|5.03||0.067|TWO_SIDED|95.0|-0.646|19.094|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||19.094|-0.646|0.0670
73957705|NCT00383188|147451048|SUPERIORITY||LSM Difference|8.261|STANDARD_ERROR_OF_MEAN|4.647||0.0757|TWO_SIDED|95.0|-0.857|17.379|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||17.379|-0.857|0.0757
73957706|NCT00383188|147451048|SUPERIORITY||LSM Difference|5.357|STANDARD_ERROR_OF_MEAN|4.427||0.2265|TWO_SIDED|95.0|-3.329|14.043|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||14.043|-3.329|0.2265
74091522|NCT02618408|147736983|SUPERIORITY|This analysis pertains to Visit 6|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.158||0.0384|TWO_SIDED|95.0|-0.64|-0.02|||Mixed Models Analysis|||||-0.02|-0.64|0.0384
73957707|NCT00383188|147451048|SUPERIORITY||LSM Difference|1.642|STANDARD_ERROR_OF_MEAN|5.178||0.7512|TWO_SIDED|95.0|-8.517|11.801|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.801|-8.517|0.7512
73957708|NCT00383188|147451048|SUPERIORITY||LSM Difference|2.888|STANDARD_ERROR_OF_MEAN|5.323||0.5876|TWO_SIDED|95.0|-7.557|13.332|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||13.332|-7.557|0.5876
73957709|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.269|STANDARD_ERROR_OF_MEAN|0.188||0.154|TWO_SIDED|95.0|-0.638|0.101|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.101|-0.638|0.1540
73957710|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.182||0.0011|TWO_SIDED|95.0|-0.958|-0.242|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.242|-0.958|0.0011
74091523|NCT02618408|147736984|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.084||0.1935|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||This analysis pertains to the inattention subscale at Visit 6.||0.06|-0.27|0.1935
74091524|NCT02618408|147736984|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.092||0.1445|TWO_SIDED|95.0|-0.32|0.05|||ANCOVA|||This analysis pertains to hyperactivity/Impulsivity subscale at Visit 6||0.05|-0.32|0.1445
73957711|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.691|STANDARD_ERROR_OF_MEAN|0.211||0.0011|TWO_SIDED|95.0|-1.105|-0.277|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.277|-1.105|0.0011
73957712|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.554|STANDARD_ERROR_OF_MEAN|0.219||0.0115|TWO_SIDED|95.0|-0.983|-0.125|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.125|-0.983|0.0115
73957713|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.185||0.094|TWO_SIDED|95.0|-0.673|0.053|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.053|-0.673|0.0940
73957714|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.459|STANDARD_ERROR_OF_MEAN|0.18||0.0109|TWO_SIDED|95.0|-0.811|-0.106|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.106|-0.811|0.0109
73957715|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.667|STANDARD_ERROR_OF_MEAN|0.208||0.0014|TWO_SIDED|95.0|-1.075|-0.259|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.259|-1.075|0.0014
73957716|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.447|STANDARD_ERROR_OF_MEAN|0.213||0.0364|TWO_SIDED|95.0|-0.867|-0.028|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.028|-0.867|0.0364
73957717|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.271|STANDARD_ERROR_OF_MEAN|0.185||0.1436|TWO_SIDED|95.0|-0.634|0.092|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.092|-0.634|0.1436
73957718|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.404|STANDARD_ERROR_OF_MEAN|0.18||0.0246|TWO_SIDED|95.0|-0.757|-0.052|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.052|-0.757|0.0246
73957719|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.546|STANDARD_ERROR_OF_MEAN|0.208||0.0088|TWO_SIDED|95.0|-0.954|-0.138|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.138|-0.954|0.0088
73957720|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.267|STANDARD_ERROR_OF_MEAN|0.213||0.2121|TWO_SIDED|95.0|-0.686|0.152|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.152|-0.686|0.2121
73957721|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.098|STANDARD_ERROR_OF_MEAN|0.185||0.5975|TWO_SIDED|95.0|-0.461|0.265|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.265|-0.461|0.5975
73957722|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.464|STANDARD_ERROR_OF_MEAN|0.18||0.0099|TWO_SIDED|95.0|-0.817|-0.112|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.112|-0.817|0.0099
74007776|NCT01910116|147566173|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.128
74007777|NCT01910116|147566174|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.126
74039278|NCT01056341|147632243|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The methodology used guaranteed that the familywise type I error rate was below the nominal one-sided significance level of 0.005.|combination tests|Superiority was tested using the closed testing procedure and combination tests for all intersection hypotheses using Simes' adjustment.||"The objective is to test the superiority of the selected arm using the approach of Posch et al.~The primary analysis was performed on the intent-to-treat population: all treated patients in Stage 1 and all treated patients in stage 2 randomized to placebo or the selected arm."||||< 0.0001
73878624|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|0.34|STANDARD_ERROR_OF_MEAN|0.523||0.5177|TWO_SIDED|80.0|-0.33|1.01||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part II Total||1.01|-0.33|0.5177
73957723|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.445|STANDARD_ERROR_OF_MEAN|0.208||0.0328|TWO_SIDED|95.0|-0.853|-0.037|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.037|-0.853|0.0328
73957724|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.213||0.3162|TWO_SIDED|95.0|-0.633|0.205|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.205|-0.633|0.3162
73957725|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.353|STANDARD_ERROR_OF_MEAN|0.185||0.0569|TWO_SIDED|95.0|-0.716|0.01|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.010|-0.716|0.0569
73957726|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.449|STANDARD_ERROR_OF_MEAN|0.18||0.0126|TWO_SIDED|95.0|-0.801|-0.096|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.096|-0.801|0.0126
73957727|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.515|STANDARD_ERROR_OF_MEAN|0.208||0.0135|TWO_SIDED|95.0|-0.923|-0.107|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.107|-0.923|0.0135
73957728|NCT00383188|147451049|SUPERIORITY||LSM Difference|-0.145|STANDARD_ERROR_OF_MEAN|0.213||0.4979|TWO_SIDED|95.0|-0.564|0.274|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.274|-0.564|0.4979
73878625|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-0.06|STANDARD_ERROR_OF_MEAN|0.523||0.9095|TWO_SIDED|80.0|-0.73|0.61||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part II Total||0.61|-0.73|0.9095
73957729|NCT00383188|147451049|SUPERIORITY||LSM Difference|0.271|STANDARD_ERROR_OF_MEAN|0.195||0.1643|TWO_SIDED|95.0|-0.111|0.653|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.653|-0.111|0.1643
73957730|NCT00383188|147451049|SUPERIORITY||LSM Difference|0.081|STANDARD_ERROR_OF_MEAN|0.185||0.6611|TWO_SIDED|95.0|-0.282|0.445|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.445|-0.282|0.6611
73957731|NCT00383188|147451049|SUPERIORITY||LSM Difference|0.097|STANDARD_ERROR_OF_MEAN|0.219||0.6587|TWO_SIDED|95.0|-0.333|0.526|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.526|-0.333|0.6587
74007778|NCT01910116|147566175|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
74007779|NCT01910116|147566176|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.660
74007780|NCT01910116|147566177|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
74007781|NCT01910116|147566178|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.186
74007782|NCT01910116|147566179|SUPERIORITY_OR_OTHER|||||||0.493|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.493
74007783|NCT01910116|147566180|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.062
74007784|NCT01910116|147566181|SUPERIORITY_OR_OTHER|||||||0.604|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.604
74007785|NCT01910116|147566182|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.252
74007786|NCT01910116|147566183|SUPERIORITY_OR_OTHER|||||||0.378|TWO_SIDED||||||Chi-squared|||||||0.378
74007787|NCT01910116|147566184|SUPERIORITY_OR_OTHER|||||||0.485|TWO_SIDED||||||Chi-squared|||||||0.485
74007788|NCT01910116|147566185|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
74007789|NCT01910116|147566186|SUPERIORITY_OR_OTHER|||||||0.683|TWO_SIDED||||||Fisher Exact|||||||0.683
74007790|NCT01910116|147566187|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Chi-squared|||||||0.036
74007791|NCT01910116|147566188|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Chi-squared|||||||0.022
74007792|NCT01910116|147566189|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Chi-squared|||||||0.017
74007793|NCT01910116|147566190|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Chi-squared|||||||0.060
74007794|NCT03606980|147566194|EQUIVALENCE|p\<0.05 was considered statistically significant. A 95% confidence interval was computed using logistic regression model.|Hazard Ratio (HR)|3.11||||0.0366|TWO_SIDED|95.0|1.073|9.005|||Cox proportional hazards analysis|||||9.005|1.073|0.0366
74007795|NCT03606980|147566194|EQUIVALENCE|p\<0.05 was considered statistically significant.|Hazard Ratio (HR)|4.16||||0.0232|TWO_SIDED|95.0|1.215|14.273|||Cox proportional hazards analysis|||||14.273|1.215|0.0232
74007796|NCT03606980|147566194|EQUIVALENCE|p\<0.05 was considered statistically significant.|Hazard Ratio (HR)|1.24||||0.64|TWO_SIDED|95.0|0.389|4.615|||Cox proportional hazards analysis|||||4.615|0.389|0.64
74007797|NCT03606980|147566195|EQUIVALENCE|All statistical tests were two-sided, and p\<0.05 was considered statistically significant.||||||0.86|||||||ANOVA|||||||0.86
74007798|NCT03606980|147566196|EQUIVALENCE|p\<00.05 was considered statistically significant.||||||0.25|||||||ANOVA|||||||0.25
74007799|NCT03606980|147566197|EQUIVALENCE|p\<0.05 considered statistically significant.||||||0.29|||||||ANOVA|||||||0.29
74007800|NCT03606980|147566198|EQUIVALENCE|All statistical tests were performed using the SAS Studio. All statistical tests were two-sided, and p\<0.05 was considered statistically significant.||||||0.57|||||||ANOVA|||||||0.57
74007801|NCT02469896|147566202|SUPERIORITY||Risk Ratio (RR)|0.875||||0.602|TWO_SIDED|95.0|0.556|1.377|||Fisher Exact|||||1.377|0.556|0.602
74007802|NCT02469896|147566203|SUPERIORITY||||||||||||||||||No statistical data was obtain because no patients died during the trial.|||
74007803|NCT02469896|147566204|SUPERIORITY||Slope|0.099||||0.922|TWO_SIDED|95.0|-1.902|2.099||Unadjusted|Mixed Models Analysis|||||2.099|-1.902|0.922
74007804|NCT02469896|147566205|SUPERIORITY||Difference of slopes|-0.008||||0.983|TWO_SIDED|95.0|-0.761|0.745|||Mixed Models Analysis|||||0.745|-0.761|0.983
74007805|NCT02469896|147566207|SUPERIORITY||Ratio of geometric means|1.15||||0.684|TWO_SIDED|95.0|0.566|2.337|||t-test, 2 sided|||PBMC IL-6 fold-change||2.337|0.566|0.684
74007806|NCT02469896|147566207|SUPERIORITY||Ratio of geometric means|1.344||||0.663|TWO_SIDED|95.0|0.331|2.08|||t-test, 2 sided|||||2.080|0.331|0.663
74007807|NCT02469896|147566207|SUPERIORITY||Ratio of geometric means|1.198||||0.5|TWO_SIDED|95.0|0.691|2.08|||t-test, 2 sided|||||2.080|0.691|0.500
74007808|NCT02469896|147566208|SUPERIORITY||Ratio of fold change|0.047|||<|0.001|TWO_SIDED|95.0|0.01|0.217|||Mixed Models Analysis|||||0.217|0.010|<0.001
74007809|NCT02469896|147566208|SUPERIORITY||Ratio of fold change|1.306||||0.247|TWO_SIDED|95.0|0.828|2.059|||Mixed Models Analysis|||||2.059|0.828|0.247
74007810|NCT02469896|147566208|SUPERIORITY||Ratio of fold change|19.591|||<|0.001|TWO_SIDED|95.0|11.143|34.446|||Mixed Models Analysis|||||34.446|11.143|<0.001
74007811|NCT02469896|147566208|SUPERIORITY||Ratio of fold change|1.264||||0.185|TWO_SIDED|95.0|0.892|1.791|||Mixed Models Analysis|||||1.791|0.892|0.185
74007812|NCT02469896|147566208|SUPERIORITY||Ratio of fold change|1.396||||0.427|TWO_SIDED|95.0|0.608|3.206|||Mixed Models Analysis|||||3.206|0.608|0.427
74007813|NCT02469896|147566208|SUPERIORITY||Ratio of fold change|0.893||||0.285|TWO_SIDED|95.0|0.725|1.1|||Mixed Models Analysis|||||1.100|0.725|0.285
74007814|NCT02469896|147566209|SUPERIORITY||Ratio of fold change|0.167||||0.011|TWO_SIDED|95.0|0.043|0.643|||Mixed Models Analysis|||||0.643|0.043|0.011
74007815|NCT02469896|147566209|SUPERIORITY||Ratio of fold change|0.741||||0.604|TWO_SIDED|95.0|0.228|2.405|||Mixed Models Analysis|||||2.405|0.228|0.604
74007816|NCT02469896|147566209|SUPERIORITY||Ratio of fold change|2.94|||<|0.001|TWO_SIDED|95.0|1.823|4.74|||Mixed Models Analysis|||||4.740|1.823|<0.001
74007817|NCT02469896|147566209|SUPERIORITY||Ratio of fold change|1.078||||0.587|TWO_SIDED|95.0|0.813|1.431|||Mixed Models Analysis|||||1.431|0.813|0.587
74007818|NCT02469896|147566209|SUPERIORITY||Ratio of fold change|1.078||||0.697|TWO_SIDED|95.0|0.728|1.595|||Mixed Models Analysis|||||1.595|0.728|0.697
74007819|NCT02469896|147566210|SUPERIORITY||Ratio of fold change|1.785|||<|0.001|TWO_SIDED|95.0|1.502|2.121|||Mixed Models Analysis|||||2.121|1.502|<0.001
74007820|NCT01294150|147566213|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Assuming unequal variances comparing mean improvement in the UL group to 125% of the mean improvement in the Control group. A p-value of 0.025 or less associated with UL is considered evidence of statistical significance|t-test, 2 sided|||||||0.003
74007821|NCT03684642|147566222|NON_INFERIORITY|Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<=0.3%.|Least Square (LS) Mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.14||||||A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.||0.14|-0.20|
74007822|NCT03684642|147566222|NON_INFERIORITY|Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% CI for the difference between groups was \<=0.3%.|LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.25|0.09||||||A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.||0.09|-0.25|
74007823|NCT03684642|147566222|SUPERIORITY|||||||0.7064||||||Threshold for significance at the level of 0.05.|ANCOVA|||||||0.7064
74007824|NCT03684642|147566222|SUPERIORITY|||||||0.3427||||||Threshold for significance at the level of 0.05.|ANCOVA|||||||0.3427
74007825|NCT04556396|147566235|SUPERIORITY||Odds Ratio (OR)|0.2|||<|0.01|TWO_SIDED|95.0|0.1|0.4|||Chi-squared|||||0.4|0.1|<0.01
74007826|NCT01667107|147566287|SUPERIORITY_OR_OTHER||Spearman rank correlation coefficient|0.53||||0.139|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations||||0.139
74007827|NCT01667107|147566287|SUPERIORITY_OR_OTHER||Spearman rank correlation coefficient|0.59||||0.057|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations||||0.057
74007828|NCT01162239|147566294|OTHER|||||||0.62|||||||Chi-squared|||||||0.62
74007829|NCT01162239|147566295|OTHER|||||||0.91|||||||Chi-squared|||||||0.91
74039279|NCT01167582|147632245|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 1 Post Randomization||||<0.001
74039280|NCT01167582|147632245|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 2 Post Randomization||||<0.001
74039281|NCT01167582|147632245|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 3 Post Randomization||||<0.001
74039282|NCT01167582|147632246|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74039283|NCT01167582|147632247|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.38|||||TWO_SIDED|95.0|0.99|5.73|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|||5.73|0.99|
74039284|NCT01167582|147632248|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.7||||||95.0|-5.3|24.7|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|||24.7|-5.3|
74039285|NCT01167582|147632249|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|7.13|||||TWO_SIDED|95.0|0.91|56.02|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Mortality||56.02|0.91|
73957732|NCT00383188|147451049|SUPERIORITY||LSM Difference|0.154|STANDARD_ERROR_OF_MEAN|0.223||0.4903|TWO_SIDED|95.0|-0.284|0.592|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.592|-0.284|0.4903
74039286|NCT01167582|147632249|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.48|4.22|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Myocardial Infarction||4.22|0.48|
74039287|NCT03103906|147632265|OTHER||Difference in proportion|2.56||||0.3334|TWO_SIDED|95.0|-19.99|25.07|||Chi-squared|||||25.07|-19.99|0.3334
74039288|NCT03571256|147632273|OTHER||LS mean difference|-0.8||||0.6|TWO_SIDED|95.0|-3.9|2.3||Threshold for significance at 0.05 level.|Mixed Models Analysis|||||2.3|-3.9|0.600
74039289|NCT00868452|147632284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|1.25||0.005|||||||Mixed Models Analysis|||||||0.005
74039290|NCT00868452|147632285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.15||0.003|||||||Mixed Models Analysis|||||||0.003
74039291|NCT00868452|147632286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.01||0.012|||||||ANCOVA|||||||0.012
74039292|NCT00643604|147632304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||0.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.69
74039293|NCT00643604|147632305|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
74039294|NCT00643604|147632306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.13
74091525|NCT02618408|147736984|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.1064|TWO_SIDED|95.0|-0.36|0.03|||ANCOVA|||This analysis pertains to the oppositional defiant disorder subscale at Visit 6||0.03|-0.36|0.1064
74039295|NCT00643604|147632307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0||||p value for Symptom Score|Wilcoxon signed rank test|||Changes in mean CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
74039296|NCT00643604|147632307|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0||||p value for Activity Score.|Wilcoxon signed rank test|||Activity Score N=5; Baseline component score could not be calculated for one subject. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
73957733|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.119|STANDARD_ERROR_OF_MEAN|0.09||0.1857|TWO_SIDED|95.0|-0.296|0.057|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.057|-0.296|0.1857
73957734|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.277|STANDARD_ERROR_OF_MEAN|0.089||0.0019|TWO_SIDED|95.0|-0.451|-0.103|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.103|-0.451|0.0019
74039297|NCT00643604|147632307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Wilcoxon signed-rank test|||Quality of Life Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.31
74039298|NCT00643604|147632307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||"Total Score N=5; Baseline Activity component score could not be calculated for one subject. Total Score could not be calculated for this subject.~Wilcoxon signed rank test was used to compare the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values."||||0.13
74039299|NCT00643604|147632308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||95.0|||||Wilcoxon signed-rank test|||Effectiveness Score Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.19
74039300|NCT00643604|147632308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||95.0|||||Wilcoxon signed-rank test|||Side-Effects Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.19
74039301|NCT00643604|147632308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Wilcoxon signed-rank test|||Convenience Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
74039302|NCT00643604|147632308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Wilcoxon signed-rank test|||Global Satisfaction Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.88
74039303|NCT00643604|147632309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Wilcoxon signed-rank test|||Gather/Set-up. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.25
74091526|NCT02618408|147736984|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.082||0.1418|TWO_SIDED|95.0|-0.28|0.04|||ANCOVA|||This analysis pertains to the combined scale score at Visit 6||0.04|-0.28|0.1418
74091527|NCT04168190|147737008|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|-10.0|||||TWO_SIDED|95.0|-29.3|9.0|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site erythema||9.0|-29.3|
73957735|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.244|STANDARD_ERROR_OF_MEAN|0.103||0.0178|TWO_SIDED|95.0|-0.446|-0.042|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.042|-0.446|0.0178
74039304|NCT00643604|147632309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||Wilcoxon signed-rank test|||Prepare Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.06
74039305|NCT00643604|147632309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0|||||Wilcoxon signed-rank test|||Connect Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.63
74039306|NCT00643604|147632309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Wilcoxon signed-rank test|||Change Dressing. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.88
74039307|NCT00643604|147632309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||Total Time. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.13
73957736|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.098|STANDARD_ERROR_OF_MEAN|0.106||0.3547|TWO_SIDED|95.0|-0.305|0.11|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.110|-0.305|0.3547
73957737|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.135|STANDARD_ERROR_OF_MEAN|0.089||0.1301|TWO_SIDED|95.0|-0.31|0.04|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.040|-0.310|0.1301
73957738|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.088||0.0313|TWO_SIDED|95.0|-0.363|-0.017|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.017|-0.363|0.0313
73957739|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.219|STANDARD_ERROR_OF_MEAN|0.102||0.0323|TWO_SIDED|95.0|-0.42|-0.019|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.019|-0.420|0.0323
73957740|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.105||0.6318|TWO_SIDED|95.0|-0.256|0.156|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.156|-0.256|0.6318
73957741|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.055|STANDARD_ERROR_OF_MEAN|0.089||0.5388|TWO_SIDED|95.0|-0.23|0.12|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.120|-0.230|0.5388
73957742|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.157|STANDARD_ERROR_OF_MEAN|0.088||0.0755|TWO_SIDED|95.0|-0.329|0.016|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.016|-0.329|0.0755
73957743|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.219|STANDARD_ERROR_OF_MEAN|0.102||0.0323|TWO_SIDED|95.0|-0.42|-0.019|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.019|-0.420|0.0323
73957744|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.072|STANDARD_ERROR_OF_MEAN|0.105||0.4948|TWO_SIDED|95.0|-0.277|0.134|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.134|-0.277|0.4948
73957745|NCT00383188|147451051|SUPERIORITY||LSM Difference|0.06|STANDARD_ERROR_OF_MEAN|0.089||0.5022|TWO_SIDED|95.0|-0.115|0.235|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.235|-0.115|0.5022
73957746|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.088||0.0307|TWO_SIDED|95.0|-0.363|-0.018|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.018|-0.363|0.0307
73957747|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.172|STANDARD_ERROR_OF_MEAN|0.102||0.0933|TWO_SIDED|95.0|-0.372|0.029|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.029|-0.372|0.0933
73957748|NCT00383188|147451051|SUPERIORITY||LSM Difference|0.027|STANDARD_ERROR_OF_MEAN|0.105||0.7967|TWO_SIDED|95.0|-0.179|0.233|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.233|-0.179|0.7967
73957749|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.034|STANDARD_ERROR_OF_MEAN|0.089||0.7059|TWO_SIDED|95.0|-0.208|0.141|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.141|-0.208|0.7059
74039308|NCT00643604|147632310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.5
74039309|NCT00643604|147632311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Wilcoxon sign-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.25
74039310|NCT00643604|147632312|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
74039311|NCT00643604|147632313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.50
73957750|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.213|STANDARD_ERROR_OF_MEAN|0.088||0.0154|TWO_SIDED|95.0|-0.386|-0.041|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.041|-0.386|0.0154
74039312|NCT00643604|147632314|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
74039313|NCT00643604|147632315|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
74039314|NCT00643604|147632316|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
74039315|NCT02702011|147632322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|65.1|STANDARD_ERROR_OF_MEAN|10.81|<|0.0001|TWO_SIDED|95.0|43.29|86.9|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 2.5 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||86.90|43.29|<0.0001
74039316|NCT02702011|147632322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.19|STANDARD_ERROR_OF_MEAN|11.1|<|0.0001|TWO_SIDED|95.0|58.8|103.58|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 10 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||103.58|58.80|<0.0001
74039317|NCT02702011|147632322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|98.11|STANDARD_ERROR_OF_MEAN|11.01|<|0.0001|TWO_SIDED|95.0|75.91|120.31|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 25 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||120.31|75.91|<0.0001
74039318|NCT02007954|147632330|OTHER|||||||0.01||||||P-values \< 0.05 considered statistically significant.|t-test, 2 sided|||Shapiro-Wilk test was run for normality. Baseline and follow-up AFP compared using two-tailed Student's t-test.||||.01
74039319|NCT02659605|147632334|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.572|||||||Student's t-test|||||||0.572
74039320|NCT02659605|147632335|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.849|||||||Student's t-test|||||||0.849
74039321|NCT02659605|147632336|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.886|||||||Student's t-test|||||||0.886
74039322|NCT02659605|147632337|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.612|||||||Student's t-test|||||||0.612
74039323|NCT02659605|147632338|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.728|||||||Student's t-test|||||||0.728
74039324|NCT02659605|147632339|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.584|||||||Student's t-test|||||||0.584
73878626|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-1.88|STANDARD_ERROR_OF_MEAN|1.255||0.1354|TWO_SIDED|80.0|-3.49|-0.27||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Total||-0.27|-3.49|0.1354
73878627|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-1.02|STANDARD_ERROR_OF_MEAN|1.262||0.4217|TWO_SIDED|80.0|-2.64|0.61||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Total||0.61|-2.64|0.4217
74007830|NCT00228566|147566296|SUPERIORITY_OR_OTHER||% Responders = 201/241|83.4||||||95.0|78.7|88.1|||Descriptive Statistics||The Overall Endpoint includes the last postbaseline value for each patient in the full analysis set, regardless of evaluation period. The Number of Responders (at least minimal improvement) at this Overall Endpoint equaled a total of 201 patients.|This was an open label study, with all patients receiving treatment with armodafinil||88.1|78.7|
74007831|NCT00232141|147566315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.3914||95.0|-0.83|0.32||The analysis procedures planned will control the Type I error for the primary analysis. No multiplicity adjustment is needed for this two-group study.|ANCOVA|||Primary hypotheses : null (H0): µA=µP vs alternative (HA): µA≠µP (µA and µP represent true means for primary endpoint in active treatment \& placebo groups respectively). Assumptions in power calculation: 2-sided test with type I error at α =0.05, type II error at β =0.10, \& a common s.d of 2.2 for primary endpoint (based on previous clinical trial data). With n=150 subjects/ group (300 subjects overall) at least 90% power to detect a treatment difference of at least 1.1 in primary endpoint||0.32|-0.83|0.3914
74007832|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0131||95.0|-0.81|-0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.10|-0.81|0.0131
74091528|NCT04168190|147737008|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-18.1|24.6|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site erythema||24.6|-18.1|
74091529|NCT04168190|147737008|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|16.7|||||TWO_SIDED|95.0|-7.7|39.3|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site pain||39.3|-7.7|
74091530|NCT04168190|147737008|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|20.0|||||TWO_SIDED|95.0|-4.1|42.1|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site pain||42.1|-4.1|
74091531|NCT04168190|147737008|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|6.7|||||TWO_SIDED|95.0|-13.2|26.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site swelling||26.5|-13.2|
73878628|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|0.09|STANDARD_ERROR_OF_MEAN|0.369||0.8053|TWO_SIDED|80.0|-0.38|0.56||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Rigidity||0.56|-0.38|0.8053
74007833|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.24||0.0393||95.0|-0.96|-0.02||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||-0.02|-0.96|0.0393
74007834|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.28||0.0554||95.0|-1.08|0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3||0.01|-1.08|0.0554
74007835|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.29||0.1513||95.0|-0.99|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4||0.15|-0.99|0.1513
74007836|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.3||0.3345||95.0|-0.89|0.3||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5||0.30|-0.89|0.3345
74007837|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.31||0.0879||95.0|-1.13|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.08|-1.13|0.0879
73878629|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|0.25|STANDARD_ERROR_OF_MEAN|0.37||0.497|TWO_SIDED|80.0|-0.22|0.73||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Rigidity||0.73|-0.22|0.4970
73878630|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-1.07|STANDARD_ERROR_OF_MEAN|0.779||0.1703|TWO_SIDED|80.0|-2.07|-0.07||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Bradykinesia||-0.07|-2.07|0.1703
73878631|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-0.44|STANDARD_ERROR_OF_MEAN|0.782||0.5729|TWO_SIDED|80.0|-1.45|0.56||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Bradykinesia||0.56|-1.45|0.5729
73878632|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-0.61|STANDARD_ERROR_OF_MEAN|0.324||0.0628|TWO_SIDED|80.0|-1.02|-0.19||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Resting Tremor||-0.19|-1.02|0.0628
73878633|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-0.41|STANDARD_ERROR_OF_MEAN|0.325||0.2125|TWO_SIDED|80.0|-0.82|0.01||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Resting Tremor||0.01|-0.82|0.2125
74007838|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.32||0.0307||95.0|-1.32|-0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7||-0.07|-1.32|0.0307
74007839|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.31||0.0156||95.0|-1.36|-0.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8||-0.14|-1.36|0.0156
74007840|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.32||0.0981||95.0|-1.15|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9||0.10|-1.15|0.0981
74007841|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.31||0.306||95.0|-0.93|0.29||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.29|-0.93|0.3060
74007842|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.33||0.1874||95.0|-1.08|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11||0.21|-1.08|0.1874
74007843|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.34||0.1025||95.0|-1.22|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12||0.11|-1.22|0.1025
74007844|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.34||0.0662||95.0|-1.3|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13||0.04|-1.30|0.0662
74007845|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.37||0.1856||95.0|-1.21|0.24||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.24|-1.21|0.1856
74007846|NCT00232141|147566316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.3||0.7925||95.0|-0.66|0.5||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.50|-0.66|0.7925
74007847|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.1191||95.0|0.802|5.935||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1||5.935|0.802|0.1191
74007848|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.5041||95.0|0.666|2.301||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2||2.301|0.666|0.5041
74007849|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.6859||95.0|0.638|1.985||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3||1.985|0.638|0.6859
74007850|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.414||95.0|0.735|2.116||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4||2.116|0.735|0.4140
74007851|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.7852||95.0|0.644|1.794||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5||1.794|0.644|0.7852
74039325|NCT00475540|147632341|SUPERIORITY|Statistical analysis was performed using SAS 9.1 software. One patient did not receive the assigned mesh treatment because the surgeon felt there was inadequate vaginal caliber, so non mesh repair was performed. This subject was analyzed in the non mesh group for the 3-month and 1-year outcomes rather than intent-to-treat approach. This subject was lost to follow-up after 12 months and not included in the 3-year analysis.|||||<|0.05|||||||t-test, 2 sided|t-tests, Wilcoxon signed rank, Wilcoxon rank-sum tests continuous variables; X2 for categorical variables. Combined cure outcomes Fisher's exact test||Sample size primary outcome 1 year: 45 participants per arm, 20% difference success (70% no mesh and 90% mesh), alpha of .05 and 80% power, 15% loss to follow-up.||||<0.05
74091532|NCT04168190|147737008|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-16.0|22.8|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site swelling||22.8|-16.0|
74007852|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7399||95.0|0.654|1.817||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6||1.817|0.654|0.7399
74007853|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.1055||95.0|0.913|2.701||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7||2.701|0.913|0.1055
74007854|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.2107||95.0|0.829|2.401||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8||2.401|0.829|0.2107
74007855|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.527||95.0|0.697|2.046||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9||2.046|0.697|0.5270
74007856|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.6845||95.0|0.513|1.546||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10||1.546|0.513|0.6845
74007857|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.7737||95.0|0.522|1.619||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11||1.619|0.522|0.7737
74007858|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.8853||95.0|0.597|1.818||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12||1.818|0.597|0.8853
74007859|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7712||95.0|0.612|1.946||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13||1.946|0.612|0.7712
74091533|NCT04168190|147737009|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-11.4|31.0|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Fatigue||31.0|-11.4|
74091534|NCT04168190|147737009|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-11.4|31.0|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Fatigue||31.0|-11.4|
74091535|NCT04168190|147737009|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-7.4|28.3|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Arthralgia||28.3|-7.4|
74091536|NCT04168190|147737009|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-13.1|20.2|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Arthralgia||20.2|-13.1|
74091537|NCT04168190|147737009|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|13.3|||||TWO_SIDED|95.0|-7.5|33.8|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Myalgia||33.8|-7.5|
74091538|NCT04168190|147737009|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|16.7|||||TWO_SIDED|95.0|-4.6|37.3|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Myalgia||37.3|-4.6|
74091539|NCT04168190|147737009|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|13.3|||||TWO_SIDED|95.0|-8.5|34.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Headache||34.5|-8.5|
74091540|NCT04168190|147737009|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-17.2|23.8|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Headache||23.8|-17.2|
74091541|NCT04168190|147737010|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-11.5|11.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|||11.5|-11.5|
74091542|NCT04168190|147737010|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-11.5|11.5|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|||11.5|-11.5|
74091543|NCT04168190|147737011|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|2.0|||||TWO_SIDED|95.0|-2.8|6.8|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site erythema||6.8|-2.8|
74091544|NCT04168190|147737011|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|8.7|||||TWO_SIDED|95.0|0.1|17.1|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site pain||17.1|0.1|
74091545|NCT04168190|147737011|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.1|||||TWO_SIDED|95.0|-2.0|8.4|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site swelling||8.4|-2.0|
74091546|NCT04168190|147737012|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|7.1|||||TWO_SIDED|95.0|0.8|13.5|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Fatigue||13.5|0.8|
74091547|NCT04168190|147737012|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Arthralgia||3.8|-3.8|
74007860|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.9586||95.0|0.574|1.796||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14||1.796|0.574|0.9586
74007861|NCT00232141|147566317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79||||0.3482||95.0|0.486|1.283||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF||1.283|0.486|0.3482
74007862|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.1132||95.0|0.882|2.969||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1||2.969|0.882|0.1132
74007863|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.4687||95.0|0.731|1.978||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2||1.978|0.731|0.4687
74007864|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.1546||95.0|0.877|2.375||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3||2.375|0.877|0.1546
74007865|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.4216||95.0|0.7444|2.025||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4||2.025|0.7444|0.4216
74007866|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.7479||95.0|0.556|1.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5||1.527|0.556|0.7479
74007867|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8||||0.3842||95.0|0.481|1.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6||1.330|0.481|0.3842
74007868|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.845||95.0|0.627|1.769||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7||1.769|0.627|0.8450
74007869|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.1602||95.0|0.864|2.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8||2.527|0.864|0.1602
74007870|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.6815||95.0|0.66|1.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9||1.890|0.660|0.6815
74091548|NCT04168190|147737012|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|1.6|||||TWO_SIDED|95.0|-3.8|7.0|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Myalgia||7.0|-3.8|
74091549|NCT04168190|147737012|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.5|||||TWO_SIDED|95.0|-2.7|9.9|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Headache||9.9|-2.7|
74091550|NCT04168190|147737013|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.5|1.5|||||Phase 2: V116 minus Phase 2: Pneumovax™23|||1.5|-1.5|
74007871|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.85||||0.5635||95.0|0.486|1.482||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10||1.482|0.486|0.5635
74007872|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.49||95.0|0.699|2.104||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11||2.104|0.699|0.4900
74007873|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.1602||95.0|0.856|2.575||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12||2.575|0.856|0.1602
74091551|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.82|1.22|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 3. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.22|0.82|<0.001
74091552|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|0.95|1.56|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 7F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.56|0.95|<0.001
74091553|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.9|1.41|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 19A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.41|0.90|<0.001
74091554|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.58|||<|0.001|TWO_SIDED|95.0|1.16|2.16|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 22F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.16|1.16|<0.001
74091555|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.71|1.24|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 33F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.24|0.71|<0.001
74091556|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.8|1.21|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 8. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.21|0.80|<0.001
74091557|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.87|1.47|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 9N. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.47|0.87|<0.001
74091558|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|0.93|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 10A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|0.93|<0.001
74091559|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|2.27|||<|0.001|TWO_SIDED|95.0|1.78|2.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 11A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.90|1.78|<0.001
74091560|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|2.57|||<|0.001|TWO_SIDED|95.0|1.86|3.55|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 12F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.55|1.86|<0.001
74091561|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.64|||<|0.001|TWO_SIDED|95.0|1.24|2.16|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 17F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.16|1.24|<0.001
74091562|NCT04168190|147737014|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.43|2.36|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 20A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.36|1.43|<0.001
74091563|NCT04168190|147737015|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|6.03|||<|0.001|TWO_SIDED|95.0|4.23|8.62|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 6A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||8.62|4.23|<0.001
74007874|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.5819||95.0|0.663|2.079||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13||2.079|0.663|0.5819
73878634|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.4577|TWO_SIDED|80.0|-0.22|0.06||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Axial Symptoms||0.06|-0.22|0.4577
74007875|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.2796||95.0|0.768|2.432||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14||2.432|0.768|0.2796
74091564|NCT04168190|147737015|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|6.8|||<|0.001|TWO_SIDED|95.0|5.37|8.62|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||8.62|5.37|<0.001
74091565|NCT04168190|147737015|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|3.0|||<|0.001|TWO_SIDED|95.0|2.31|3.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15C. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.90|2.31|<0.001
74091566|NCT04168190|147737015|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|18.21|||<|0.001|TWO_SIDED|95.0|12.98|25.57|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 16F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||25.57|12.98|<0.001
74091567|NCT04168190|147737015|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|19.45|||<|0.001|TWO_SIDED|95.0|12.87|29.4|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||29.40|12.87|<0.001
74091568|NCT04168190|147737015|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|29.88|||<|0.001|TWO_SIDED|95.0|20.72|43.09|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||43.09|20.72|<0.001
74091569|NCT04168190|147737015|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|32.02|||<|0.001|TWO_SIDED|95.0|22.83|44.89|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 24F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||44.89|22.83|<0.001
74091570|NCT04168190|147737015|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|34.9|||<|0.001|TWO_SIDED|95.0|24.25|50.23|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 31. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||50.23|24.25|<0.001
74091571|NCT04168190|147737015|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|9.0|||<|0.001|TWO_SIDED|95.0|7.19|11.26|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 35B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||11.26|7.19|<0.001
74091572|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.58|1.42|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 3||1.42|0.58|
73878635|NCT03100149|147296930|SUPERIORITY||Difference in Adjusted Means|-0.01|STANDARD_ERROR_OF_MEAN|0.109||0.9182|TWO_SIDED|80.0|-0.15|0.13||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Axial Symptoms||0.13|-0.15|0.9182
73878636|NCT03100149|147296931|SUPERIORITY||LS Means Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3582|TWO_SIDED|80.0|-0.05|0.01||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.01|-0.05|0.3582
74007876|NCT00232141|147566318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.86||||0.5437||95.0|0.534|1.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF||1.390|0.534|0.5437
74007877|NCT00232141|147566319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|2.53||0.5425||95.0|-3.44|6.52||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Disturbance.||6.52|-3.44|0.5425
74007878|NCT00232141|147566319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.25||0.3184||95.0|-0.75|0.25||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Quantity||0.25|-0.75|0.3184
74007879|NCT00232141|147566319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|2.92||0.9886||95.0|-5.81|5.72||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Adequacy||5.72|-5.81|0.9886
74007880|NCT00232141|147566319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.41|STANDARD_ERROR_OF_MEAN|2.51||0.5742||95.0|-3.53|6.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Awaken Short of Breath or with Headache||6.35|-3.53|0.5742
74007881|NCT00232141|147566319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|2.5||0.5775||95.0|-3.54|6.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Somnolence||6.33|-3.54|0.5775
74007882|NCT00232141|147566319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.34|STANDARD_ERROR_OF_MEAN|3.21||0.004||95.0|3.02|15.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Snoring||15.66|3.02|0.0040
74007883|NCT00232141|147566319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.07|STANDARD_ERROR_OF_MEAN|1.98||0.5882||95.0|-2.83|4.97||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index I||4.97|-2.83|0.5882
74007884|NCT00232141|147566319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.42|STANDARD_ERROR_OF_MEAN|1.89||0.4516||95.0|-2.3|5.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index II||5.14|-2.30|0.4516
74007885|NCT00232141|147566320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.39||0.5105||95.0|-0.51|1.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Anxiety||1.03|-0.51|0.5105
74007886|NCT00232141|147566320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.37||0.2513||95.0|-0.3|1.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Depression||1.14|-0.30|0.2513
74007887|NCT00232141|147566321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.27||0.5834||95.0|-0.38|0.67||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Severity Index||0.67|-0.38|0.5834
74007888|NCT00232141|147566321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.25||0.7783||95.0|-0.43|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Interference Index||0.57|-0.43|0.7783
74007889|NCT00232141|147566322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.27||0.4776||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||||0.34|-0.73|0.4776
74007890|NCT00232141|147566323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0077||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.0077
74091573|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.71|1.76|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 3||1.76|0.71|
74091574|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.63|1.99|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 7F||1.99|0.63|
74091575|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.14|||||TWO_SIDED|95.0|1.19|3.84|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 7F||3.84|1.19|
74007891|NCT00232141|147566324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3852||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.3852
74007892|NCT00232141|147566325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3097||95.0|-0.03|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Burning||0.10|-0.03|0.3097
73878637|NCT03100149|147296931|SUPERIORITY||LS Means Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1955|TWO_SIDED|80.0|-0.06|0.0||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.00|-0.06|0.1955
74007893|NCT00232141|147566325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.6147||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pressing||0.04|-0.07|0.6147
74007894|NCT00232141|147566325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6838||95.0|-0.05|0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paroxysmal||0.07|-0.05|0.6838
74007895|NCT00232141|147566325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6479||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Evoked||0.04|-0.07|0.6479
74007896|NCT00232141|147566325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.1849||95.0|-0.02|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paresthesia/dysesthesia||0.11|-0.02|0.1849
74007897|NCT00232141|147566325|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5898||95.0|0.0|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Total Score||0|0|0.5898
74007898|NCT00232141|147566326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.29||0.6865||95.0|-0.45|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Static mechanical allodynia||0.68|-0.45|0.6865
74039326|NCT02259127|147632354|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.08|||=|0.004|TWO_SIDED|95.0|-0.14|-0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Primary: Diff in adj. KM estimates (\>=14kg)~Number of subjects included in analysis: 707~Analysis specification: Pre-specified"||-0.03|-0.14|= 0.004
74039327|NCT02259127|147632354|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.18|||=|0.057|TWO_SIDED|95.0|-0.36|0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Diff in adj. KM estimates (Frequentist \<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||0.02|-0.36|=0.057
74091576|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.27|||||TWO_SIDED|95.0|0.74|2.21|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 19A||2.21|0.74|
74091577|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.08|||||TWO_SIDED|95.0|1.19|3.63|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 19A||3.63|1.19|
74091578|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.74|||||TWO_SIDED|95.0|0.37|1.46|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 22F||1.46|0.37|
74091579|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.5|2.0|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 22F||2.00|0.50|
74091580|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.75|||||TWO_SIDED|95.0|0.4|1.41|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 33F||1.41|0.40|
74091581|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.32|||||TWO_SIDED|95.0|0.7|2.48|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 33F||2.48|0.70|
73878638|NCT03100149|147296932|SUPERIORITY||Difference in Adjusted Means|0.22|STANDARD_ERROR_OF_MEAN|0.245||0.3611|TWO_SIDED|80.0|-0.09|0.54||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.54|-0.09|0.3611
73878639|NCT03100149|147296932|SUPERIORITY||Difference in Adjusted Means|0.44|STANDARD_ERROR_OF_MEAN|0.243||0.0727|TWO_SIDED|80.0|0.13|0.75||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.75|0.13|0.0727
73878640|NCT03100149|147296933|SUPERIORITY||Odds Ratio (OR)|0.77||||0.4265|TWO_SIDED|80.0|0.5|1.18||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.18|0.50|0.4265
74007899|NCT00232141|147566326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.3787||95.0|-0.71|0.27||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Dynamic mechanical allodynia||0.27|-0.71|0.3787
74007900|NCT00232141|147566326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.35||0.7704||95.0|-0.79|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Punctate hyperalgesia testing area||0.59|-0.79|0.7704
74007901|NCT00232141|147566326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.33||0.6088||95.0|-0.82|0.48||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Temporal summation to tactile stimuli||0.48|-0.82|0.6088
74007902|NCT00232141|147566326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.33||0.3767||95.0|-0.93|0.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold allodynia testing area||0.35|-0.93|0.3767
74007903|NCT00232141|147566326|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.38||0.7689||95.0|-0.64|0.86||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold hyperalgesia testing area||0.86|-0.64|0.7689
74039328|NCT02259127|147632354|NON_INFERIORITY|Bayesian estimation was used for the primary analysis of the difference in treatment failure by 96 weeks by arm in \<14kg cohort. An informative prior distribution was used based on the treatment effect observed in \>=14kg cohort, with relative weight defined by clinical opinion, solicited prior to the main trial results.|Risk Difference (RD)|-0.1||||0.02|TWO_SIDED|95.0|-0.19|-0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Primary: diff in adj. KM estimates (Bayesian \<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||-0.02|-0.19|0.02
74039329|NCT02259127|147632354|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.12||||0.003|TWO_SIDED|95.0|-0.21|-0.04|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A\>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.04|-0.21|0.003
73878641|NCT03100149|147296933|SUPERIORITY||Odds Ratio (OR)|0.76||||0.4063|TWO_SIDED|80.0|0.49|1.16||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.16|0.49|0.4063
74007904|NCT00232141|147566327|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.25||0.1277||95.0|-0.86|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||||0.11|-0.86|0.1277
74007905|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0469||95.0|-0.71|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.00|-0.71|0.0469
74007906|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0067||95.0|-1.08|-0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||-0.18|-1.08|0.0067
74007907|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.27||0.031||95.0|-1.1|-0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3||-0.05|-1.10|0.0310
74039330|NCT02259127|147632354|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.05||||0.22|TWO_SIDED|95.0|-0.12|0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.03|-0.12|0.22
74039331|NCT02259127|147632355|SUPERIORITY||Risk Difference (RD)|5.0|||=|0.1377|TWO_SIDED|95.0|-1.0|11.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 665~Analysis Specification: Pre-specified"||11|-1|= 0.1377
73878642|NCT03100149|147296934|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3847|TWO_SIDED|80.0|0.48|1.15||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.15|0.48|0.3847
73878643|NCT03100149|147296934|SUPERIORITY||Odds Ratio (OR)|0.88||||0.7055|TWO_SIDED|80.0|0.57|1.36||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.36|0.57|0.7055
74039332|NCT02259127|147632355|SUPERIORITY||Risk Difference (RD)|-1.0|||=|0.8895|TWO_SIDED|95.0|-10.0|8.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted difference (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 286~Analysis Specification: Pre-specified"||8|-10|= 0.8895
74039333|NCT02259127|147632355|SUPERIORITY||Risk Difference (RD)|9.0|||=|0.0435|TWO_SIDED|95.0|0.4|17.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 381~Analysis Specification: Pre-specified"||17|0.4|=0.0435
74039334|NCT02259127|147632355|SUPERIORITY||Risk Difference (RD)|26.0||||0.021|TWO_SIDED|95.0|6.0|47.0|||Regression, Logistic|||||47|6|0.021
74039335|NCT02259127|147632356|SUPERIORITY||Risk Difference (RD)|3.0|||=|0.2256|TWO_SIDED|95.0|-2.0|8.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 670~Analysis Specification: Pre-specified"||8|-2|= 0.2256
74039336|NCT02259127|147632356|SUPERIORITY||Risk Difference (RD)|0.0|||=|0.9536|TWO_SIDED|95.0|-8.0|7.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 286~Analysis Specification: Pre-specified"||7|-8|= 0.9536
74039337|NCT02259127|147632356|SUPERIORITY||Risk Difference (RD)|6.0|||=|0.1104|TWO_SIDED|95.0|-1.0|12.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 384~Analysis Specification: Pre-specified"||12|-1|= 0.1104
74039338|NCT02259127|147632356|SUPERIORITY||Risk Difference (RD)|19.0||||0.038|TWO_SIDED|95.0|2.0|37.0|||Regression, Logistic|||||37|2|0.038
74039339|NCT02259127|147632357|SUPERIORITY||Mean Difference (Final Values)|35.0|||=|0.144|TWO_SIDED|95.0|-12.0|82.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusted for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||82|-12|= 0.144
74039340|NCT02259127|147632357|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.185|TWO_SIDED|95.0|-21.0|109.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusting for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||109|-21|0.185
74039341|NCT02259127|147632357|SUPERIORITY||Mean Difference (Final Values)|27.0|||=|0.427|TWO_SIDED|95.0|-39.0|93.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusting for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||93|-39|= 0.427
74039342|NCT02259127|147632357|SUPERIORITY||Median Difference (Final Values)|30.0||||0.86|TWO_SIDED|95.0|-308.0|368.0|||Regression, Linear|||||368|-308|0.86
74039343|NCT02259127|147632358|SUPERIORITY||Mean Difference (Final Values)|-15.1|||<|0.001|TWO_SIDED|95.0|-19.0|-11.1|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-11.1|-19|< 0.001
74039344|NCT02259127|147632358|SUPERIORITY||Mean Difference (Final Values)|-24.4|||=|0.0032|TWO_SIDED|95.0|-40.3|-8.5|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\<14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||-8.5|-40.3|= 0.0032
74039345|NCT02259127|147632358|SUPERIORITY||Mean Difference (Final Values)|-17.5|||<|0.001|TWO_SIDED|95.0|-23.9|-11.1|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-11.1|-23.9|< 0.001
74039346|NCT02259127|147632358|SUPERIORITY||Mean Difference (Final Values)|-13.4|||<|0.001|TWO_SIDED|95.0|-18.5|-8.4|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||-8.4|-18.5|< 0.001
74039347|NCT02259127|147632359|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.53|TWO_SIDED|95.0|0.55|1.36|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.36|0.55|= 0.53
74039348|NCT02259127|147632359|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.86|TWO_SIDED|95.0|0.47|2.49|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||2.49|0.47|= 0.86
74039349|NCT02259127|147632359|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.52|TWO_SIDED|95.0|0.48|1.46|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.46|0.48|= 0.52
74039350|NCT02259127|147632359|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.86|TWO_SIDED|95.0|0.42|2.04|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||2.04|0.42|= 0.86
74039351|NCT02259127|147632360|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.24|TWO_SIDED|95.0|0.61|1.13|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.13|0.61|= 0.24
73878644|NCT03100149|147296935|SUPERIORITY||Difference in Adjusted Means|-0.73|STANDARD_ERROR_OF_MEAN|0.888||0.4142|TWO_SIDED|80.0|-1.87|0.41||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.41|-1.87|0.4142
74039352|NCT02259127|147632360|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.83|TWO_SIDED|95.0|0.5|1.74|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||1.74|0.5|= 0.83
74039353|NCT02259127|147632360|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.57|TWO_SIDED|95.0|0.75|1.7|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.7|0.75|= 0.57
74039354|NCT02259127|147632360|SUPERIORITY||Hazard Ratio (HR)|0.54|||=|0.01|TWO_SIDED|95.0|0.33|0.88|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.88|0.33|= 0.01
74039355|NCT02259127|147632361|SUPERIORITY||Hazard Ratio (HR)|0.29|||=|0.01|TWO_SIDED|95.0|0.11|0.77|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||0.77|0.11|= 0.01
74039356|NCT02259127|147632361|SUPERIORITY||Hazard Ratio (HR)|0.35|||=|0.13|TWO_SIDED|95.0|0.09|1.33|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.33|0.09|= 0.13
74039357|NCT02259127|147632361|SUPERIORITY||Hazard Ratio (HR)|0.22||||0.055|TWO_SIDED|95.0|0.05|1.03|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||1.03|0.05|0.055
74039358|NCT02259127|147632362|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.06|||=|0.003|TWO_SIDED|95.0|-0.1|-0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-0.02|-0.1|= 0.003
74039359|NCT02259127|147632362|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.07|||=|0.035|TWO_SIDED|95.0|-0.13|-0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.01|-0.13|= 0.035
74039879|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.0271|TWO_SIDED|95.0|-0.59|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.59|0.0271
74007908|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.27||0.2088||95.0|-0.86|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4||0.19|-0.86|0.2088
74007909|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.26||0.1849||95.0|-0.87|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5||0.17|-0.87|0.1849
74007910|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.27||0.0452||95.0|-1.09|-0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||-0.01|-1.09|0.0452
74007911|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.29||0.0359||95.0|-1.18|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7||-0.04|-1.18|0.0359
74007912|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.29||0.0184||95.0|-1.26|-0.12||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8||-0.12|-1.26|0.0184
74007913|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.29||0.1043||95.0|-1.06|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9||0.10|-1.06|0.1043
74007914|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.29||0.1053||95.0|-1.04|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.10|-1.04|0.1053
74007915|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.3||0.144||95.0|-1.03|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11||0.15|-1.03|0.1440
74007916|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.32||0.0866||95.0|-1.17|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12||0.08|-1.17|0.0866
74007917|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.32||0.0359||95.0|-1.3|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13||-0.04|-1.30|0.0359
74007918|NCT00232141|147566328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.34||0.0711||95.0|-1.3|0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.05|-1.30|0.0711
74007919|NCT00232141|147566330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.23||0.0685||95.0|-0.89|0.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.03|-0.89|0.0685
74007920|NCT00232141|147566330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.28||0.928||95.0|-0.52|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.57|-0.52|0.9280
74091582|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.64|||||TWO_SIDED|95.0|0.37|1.08|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 8||1.08|0.37|
74091583|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.58|1.69|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 8||1.69|0.58|
74091584|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.57|1.85|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 9N||1.85|0.57|
74091585|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.64|||||TWO_SIDED|95.0|0.9|2.97|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 9N||2.97|0.90|
74039360|NCT02259127|147632362|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.05|||=|0.039|TWO_SIDED|95.0|-0.11|-0.004|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||-0.004|-0.11|= 0.039
74039361|NCT02259127|147632362|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.18||||0.057|TWO_SIDED|95.0|-0.36|0.02|||Other [Bootstrap method]|||||0.02|-0.36|0.057
74039362|NCT02259127|147632363|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.09|||=|0.003|TWO_SIDED|95.0|-0.16|-0.04|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-0.04|-0.16|= 0.003
74039363|NCT02259127|147632363|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.12|||=|0.009|TWO_SIDED|95.0|-0.21|-0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.03|-0.21|= 0.009
74039364|NCT02259127|147632363|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.08|||=|0.079|TWO_SIDED|95.0|-0.16|0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.01|-0.16|= 0.079
74039365|NCT02259127|147632364|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.993|TWO_SIDED|95.0|0.38|2.68|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||2.68|0.38|= 0.993
74039366|NCT02259127|147632364|SUPERIORITY||Hazard Ratio (HR)|0.5|||=|0.33|TWO_SIDED|95.0|0.13|2.0|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||2|0.13|= 0.33
74039367|NCT02259127|147632364|SUPERIORITY||Hazard Ratio (HR)|1.01|||=|0.991|TWO_SIDED|95.0|0.32|3.12|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||3.12|0.32|= 0.991
74091586|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.25|||||TWO_SIDED|95.0|0.67|2.32|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 10A||2.32|0.67|
74039368|NCT02259127|147632364|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.997|TWO_SIDED|95.0|0.14|7.13|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||7.13|0.14|= 0.997
74091587|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.84|||||TWO_SIDED|95.0|0.98|3.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 10A||3.45|0.98|
74091588|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.42|1.38|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 11A||1.38|0.42|
74091589|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.59|||||TWO_SIDED|95.0|0.87|2.91|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 11A||2.91|0.87|
74091590|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.5|2.17|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 12F||2.17|0.50|
74007921|NCT00232141|147566330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.29||0.6672||95.0|-0.71|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.71|0.6672
74007922|NCT00232141|147566330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.29||0.9731||95.0|-0.57|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.59|-0.57|0.9731
74007923|NCT00232141|147566330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.33||0.9045||95.0|-0.61|0.69||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.69|-0.61|0.9045
74007924|NCT00232141|147566330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.3||0.8298||95.0|-0.53|0.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.66|-0.53|0.8298
74007925|NCT00232141|147566331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.24||0.8605||95.0|-0.52|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.44|-0.52|0.8605
74007926|NCT00232141|147566331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.27||0.8348||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.47|-0.58|0.8348
74007927|NCT00232141|147566331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.26||0.2227||95.0|-0.83|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.19|-0.83|0.2227
74007928|NCT00232141|147566331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.27||0.4753||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.34|-0.73|0.4753
74007929|NCT00232141|147566331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.27||0.6017||95.0|-0.4|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.68|-0.40|0.6017
74007930|NCT00232141|147566331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.26||0.6158||95.0|-0.38|0.64||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.64|-0.38|0.6158
74007931|NCT00232141|147566332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.22||0.239||95.0|-0.69|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.17|-0.69|0.2390
74007932|NCT00232141|147566332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.24||0.9444||95.0|-0.49|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.45|-0.49|0.9444
74007933|NCT00232141|147566332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.27||0.7386||95.0|-0.63|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.63|0.7386
74007934|NCT00232141|147566332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.27||0.3493||95.0|-0.79|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.28|-0.79|0.3493
74007935|NCT00232141|147566332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.3||0.6596||95.0|-0.46|0.73||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.73|-0.46|0.6596
74039880|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0085|TWO_SIDED|95.0|-0.66|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.66|0.0085
73878645|NCT03100149|147296935|SUPERIORITY||Difference in Adjusted Means|-0.67|STANDARD_ERROR_OF_MEAN|0.885||0.4486|TWO_SIDED|80.0|-1.81|0.47||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.47|-1.81|0.4486
73878646|NCT03100149|147296936|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3769|TWO_SIDED|80.0|0.94|1.42||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.42|0.94|0.3769
73878647|NCT03100149|147296936|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.1658|TWO_SIDED|80.0|1.02|1.53||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.53|1.02|0.1658
74007936|NCT00232141|147566332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.27||0.4075||95.0|-0.31|0.77||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.77|-0.31|0.4075
74007937|NCT00232141|147566333|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.0202||95.0|-1.01|-0.09||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.09|-1.01|0.0202
74007938|NCT00232141|147566333|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8865||95.0|-0.55|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.47|-0.55|0.8865
74007939|NCT00232141|147566333|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9964||95.0|-0.54|0.54||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.54|-0.54|0.9964
74007940|NCT00232141|147566333|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5993||95.0|-0.7|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.41|-0.70|0.5993
74007941|NCT00232141|147566333|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.31||0.3553||95.0|-0.33|0.9||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.90|-0.33|0.3553
74007942|NCT00232141|147566333|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.29||0.2771||95.0|-0.25|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.88|-0.25|0.2771
74007943|NCT00232141|147566334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.26||0.2352||95.0|-0.82|0.2||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.20|-0.82|0.2352
74007944|NCT00232141|147566334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7607||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.44|-0.60|0.7607
73878648|NCT03100149|147296937|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9542|TWO_SIDED|80.0|0.77|1.33||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.33|0.77|0.9542
74007945|NCT00232141|147566334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.27||0.6563||95.0|-0.64|0.4||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.40|-0.64|0.6563
74007946|NCT00232141|147566334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.27||0.8319||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.47|-0.58|0.8319
74007947|NCT00232141|147566334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3086||95.0|-0.28|0.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.89|-0.28|0.3086
74039369|NCT02259127|147632365|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.07|||=|0.015|TWO_SIDED|95.0|-0.12|-0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 677~Analysis Specification: Pre-specified"||-0.01|-0.12|= 0.015
74039370|NCT02259127|147632365|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.172|||=|0.075|TWO_SIDED|95.0|-0.362|0.029|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Adjusted difference (frequentist \<14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||0.029|-0.362|= 0.075
74039371|NCT02259127|147632365|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.126|||=|0.004|TWO_SIDED|95.0|-0.21|-0.036|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 295~Analysis Specification: Pre-specified"||-0.036|-0.21|= 0.004
74007948|NCT00232141|147566334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.28||0.7972||95.0|-0.48|0.62||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.62|-0.48|0.7972
74007949|NCT00232141|147566335|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.28||0.1863||95.0|-0.94|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.18|-0.94|0.1863
74007950|NCT00232141|147566335|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|-0.31||0.5953||95.0|-0.77|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.44|-0.77|0.5953
74007951|NCT00232141|147566335|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.28||0.508||95.0|-0.73|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.36|-0.73|0.5080
74007952|NCT00232141|147566335|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5842||95.0|-0.7|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.39|-0.70|0.5842
74007953|NCT00232141|147566335|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.3||0.4286||95.0|-0.35|0.83||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.83|-0.35|0.4286
74007954|NCT00232141|147566335|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.28||0.5766||95.0|-0.4|0.71||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.71|-0.40|0.5766
74007955|NCT00232141|147566336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.28||0.5493||95.0|-0.73|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.39|-0.73|0.5493
74007956|NCT00232141|147566336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9875||95.0|-0.58|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.59|-0.58|0.9875
74007957|NCT00232141|147566336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.29||0.6931||95.0|-0.68|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.68|0.6931
74007958|NCT00232141|147566336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4614||95.0|-0.34|0.75||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.75|-0.34|0.4614
74007959|NCT00232141|147566336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.31||0.1467||95.0|-0.16|1.06||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||1.06|-0.16|0.1467
74007960|NCT00232141|147566336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.29||0.2819||95.0|-0.25|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.87|-0.25|0.2819
74007961|NCT00232141|147566337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8727||95.0|-0.55|0.46||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.46|-0.55|0.8727
74007962|NCT00232141|147566337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.28||0.6897||95.0|-0.65|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.43|-0.65|0.6897
74007963|NCT00232141|147566337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7527||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.44|-0.60|0.7527
74007964|NCT00232141|147566337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.28||0.6394||95.0|-0.67|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.41|-0.67|0.6394
74007965|NCT00232141|147566337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.31||0.1188||95.0|-0.13|1.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||1.11|-0.13|0.1188
74007966|NCT00232141|147566337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.28||0.2685||95.0|-0.24|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.87|-0.24|0.2685
74007967|NCT00232141|147566338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.28||0.4991||95.0|-0.74|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.36|-0.74|0.4991
74039881|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.18||0.0027|TWO_SIDED|95.0|-0.87|-0.18|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.87|0.0027
74039372|NCT02259127|147632365|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.023|||=|0.547|TWO_SIDED|95.0|-0.096|0.056|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 382~Analysis Specification: Pre-specified"||0.056|-0.096|= 0.547
74007968|NCT00232141|147566338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6094||95.0|-0.73|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.43|-0.73|0.6094
74007969|NCT00232141|147566338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.26||0.3669||95.0|-0.76|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.28|-0.76|0.3669
74007970|NCT00232141|147566338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7641||95.0|-0.43|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.59|-0.43|0.7641
74007971|NCT00232141|147566338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.27||0.9428||95.0|-0.51|0.55||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.55|-0.51|0.9428
74007972|NCT00232141|147566338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.26||0.9508||95.0|-0.52|0.49||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.49|-0.52|0.9508
74007973|NCT00232141|147566339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.25||0.0073||95.0|-1.18|-0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.19|-1.18|0.0073
74007974|NCT00232141|147566339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.3||0.2202||95.0|-0.96|0.22||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.22|-0.96|0.2202
74007975|NCT00232141|147566339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.29||0.1824||95.0|-0.95|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.18|-0.95|0.1824
74007976|NCT00232141|147566339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.3||0.1872||95.0|-0.98|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.19|-0.98|0.1872
74007977|NCT00232141|147566339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.32||0.4374||95.0|-0.38|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.88|-0.38|0.4374
74007978|NCT00232141|147566339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.3||0.4406||95.0|-0.36|0.82||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.82|-0.36|0.4406
74039373|NCT02259127|147632380|SUPERIORITY||Mean Difference (Final Values)|1.0|||=|0.004|TWO_SIDED|95.0|0.3|1.7|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.7|0.3|= 0.004
74007979|NCT00232141|147566340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.27||0.2277||95.0|-0.86|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.21|-0.86|0.2277
74007980|NCT00232141|147566340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.8407||95.0|-0.71|0.58||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.58|-0.71|0.8407
74007981|NCT00232141|147566340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.8809||95.0|-0.62|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.53|-0.62|0.8809
74007982|NCT00232141|147566340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.29||0.6288||95.0|-0.72|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.43|-0.72|0.6288
74007983|NCT00232141|147566340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.3||0.9739||95.0|-0.59|0.61||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.61|-0.59|0.9739
74007984|NCT00232141|147566340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.8926||95.0|-0.61|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.53|-0.61|0.8926
74007985|NCT00232141|147566343|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7136||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.7136
74007986|NCT00232141|147566344|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6729||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.6729
74007987|NCT01479829|147566348|SUPERIORITY||Chi-square value|5.3466||||0.02|TWO_SIDED||||||Chi-squared||The chi-square value with 1 degree of freedom was 5.3466.|The null hypothesis is that there is no difference in the response rate between patients assigned to the intervention cohort or control cohort.||||.02
74007988|NCT01479829|147566349|SUPERIORITY||Chi-square value|13.3821|||<|0.001|TWO_SIDED||||||Chi-squared||The chi-square value with 1 degree of freedom was 13.3821.|The null hypothesis is that there is no difference in the remission rate between patients assigned to the intervention cohort or control cohort.||||<.001
74007989|NCT00601250|147566350|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.78|-0.5|||ANCOVA|||Linagliptin vs. Placebo||-0.5|-0.78|<0.0001
74007990|NCT00601250|147566351|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.431|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.53|-0.333|||ANCOVA|||Linagliptin vs. Placebo||-0.333|-0.530|<0.0001
74007991|NCT00601250|147566352|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.596|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001||95.0|-0.721|-0.471|||ANCOVA|||Linagliptin vs. Placebo||-0.471|-0.721|<0.0001
74007992|NCT00601250|147566353|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.648|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|-0.785|-0.512|||ANCOVA|||Linagliptin vs. Placebo||-0.512|-0.785|<0.0001
74007993|NCT00601250|147566354|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-21.13|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001||95.0|-27.3|-14.96|||ANCOVA|||Linagliptin vs. Placebo||-14.96|-27.3|<0.0001
74007994|NCT00601250|147566355|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.52|STANDARD_ERROR_OF_MEAN|2.67|<|0.0001||95.0|-21.76|-11.29|||ANCOVA|||Linagliptin vs. Placebo||-11.29|-21.76|<0.0001
74007995|NCT00601250|147566356|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.73|STANDARD_ERROR_OF_MEAN|2.91|<|0.0001||95.0|-22.44|-11.01|||ANCOVA|||Linagliptin vs. Placebo||-11.01|-22.44|<0.0001
74007996|NCT00601250|147566357|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.83|STANDARD_ERROR_OF_MEAN|3.05|<|0.0001||95.0|-26.81|-14.84|||ANCOVA|||Linagliptin vs. Placebo||-14.84|-26.81|<0.0001
74007997|NCT00601250|147566358|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.395|||<|0.0001||95.0|2.41|8.013|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||8.013|2.410|<0.0001
74007998|NCT00601250|147566360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.456||||0.0016||95.0|1.907|15.614|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||15.614|1.907|0.0016
73878649|NCT03100149|147296937|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4567|TWO_SIDED|80.0|0.63|1.13||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.13|0.63|0.4567
74007999|NCT00601250|147566362|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.754|||<|0.0001||95.0|2.486|5.669|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.669|2.486|<0.0001
74008000|NCT00601250|147566363|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-67.13|STANDARD_ERROR_OF_MEAN|13.88|<|0.0001|TWO_SIDED|95.0|-94.69|-39.58|||ANCOVA|||Linagliptin vs. Placebo||-39.58|-94.69|<0.0001
74008001|NCT00601250|147566364|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-41.8|STANDARD_ERROR_OF_MEAN|10.02|<|0.0001|TWO_SIDED|95.0|-61.71|-21.89|||ANCOVA|||Linagliptin vs. Placebo||-21.89|-61.71|<0.0001
74008002|NCT01791803|147566365|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.6|||||TWO_SIDED|95.0|1.1|11.4||||||||11.4|1.1|
74008003|NCT01791803|147566365|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.4|||||TWO_SIDED|95.0|1.04|9.7||||||||9.7|1.04|
74008004|NCT01791803|147566366|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.8|6.2||||Adjusted for gender, marital status, diagnosis at enrollment.||||6.2|0.8|
74008005|NCT01791803|147566366|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||||TWO_SIDED|95.0|1.2|10.0||||||||10|1.2|
74008006|NCT01791803|147566367|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Comparison of smoking status at 12 weeks after hospitalization for a cardiac or pulmonary diagnosis||||< 0.001
74008007|NCT01791803|147566367|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANOVA|||Comparison of smoking stars at 26 weeks after hospitalization for a cardiac or a pulmonary illness||||0.07
74008008|NCT00523718|147566384|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Chi-squared|||||||.24
74008009|NCT02137512|147566393|SUPERIORITY|No adjustments were made for multiple comparisons.|||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008010|NCT02137512|147566393|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74039374|NCT02259127|147632380|SUPERIORITY||Mean Difference (Final Values)|1.4|||=|0.024|TWO_SIDED|95.0|0.2|2.5|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of weight at week 96, adjusting for randomised arm, baseline weight and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||2.5|0.2|= 0.024
74039375|NCT02259127|147632380|SUPERIORITY||Mean Difference (Final Values)|0.8|||=|0.075|TWO_SIDED|95.0|-0.1|1.6|||Regression, Linear|||"Statistical Analysis Title: Adjusting Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of weight at week 96, adjusting for randomised arm, baseline weight and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||1.6|-0.1|= 0.075
74039376|NCT02259127|147632380|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.8|0.5|||Regression, Linear|||||0.5|-0.8|0.67
74039377|NCT02259127|147632381|SUPERIORITY||Mean Difference (Final Values)|0.13|||=|0.036|TWO_SIDED|95.0|0.01|0.25|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||0.25|0.01|= 0.036
74039378|NCT02259127|147632381|SUPERIORITY||Mean Difference (Final Values)|0.17|||=|0.092|TWO_SIDED|95.0|-0.03|0.36|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||0.36|-0.03|=0.092
74039379|NCT02259127|147632381|SUPERIORITY||Mean Difference (Final Values)|0.1|||=|0.176|TWO_SIDED|95.0|-0.05|0.25|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.25|-0.05|=0.176
74039380|NCT02259127|147632381|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.5|TWO_SIDED|95.0|-1.1|0.5|||Regression, Linear|||||0.5|-1.1|0.50
74039381|NCT00640146|147632398|OTHER|||||||0.0213|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 2 hours of the first dose of study drug, testing MNTX against placebo.||||0.0213
74039382|NCT00640146|147632399|OTHER|||||||0.0463|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 4 hours of the first dose of study drug, testing MNTX against placebo.||||0.0463
74039383|NCT04058158|147632404|EQUIVALENCE|Pre-defined equivalence margin was \[-337.2 to 337.2\].|Least squares mean difference|34.48|||||TWO_SIDED|95.0|-47.66|116.62||||||||116.62|-47.66|
74039384|NCT04058158|147632405|EQUIVALENCE|Pre-defined equivalence margin was \[0.77 to 1.29\].|Ratio of geometric least squares mean|1.08|||||TWO_SIDED|90.0|0.95|1.23||||||||1.23|0.95|
74008011|NCT02137512|147566393|SUPERIORITY|||||||0.31||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.31
74008012|NCT02137512|147566394|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
74008013|NCT02137512|147566394|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008014|NCT02137512|147566394|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008015|NCT02137512|147566395|SUPERIORITY|||||||0.1||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.10
74008016|NCT02137512|147566395|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008017|NCT02137512|147566395|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008018|NCT02137512|147566396|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008019|NCT02137512|147566396|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008020|NCT02137512|147566396|SUPERIORITY|||||||0.91||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.91
74008021|NCT02137512|147566397|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74039385|NCT04847141|147632406|SUPERIORITY||Difference in Percentage|-3.6||||0.5167|TWO_SIDED|95.0|-14.6|7.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants meeting the primary efficacy endpoint between C19-IG 20% 1 g and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||7.4|-14.6|0.5167
74091591|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.14|||||TWO_SIDED|95.0|1.02|4.5|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 12F||4.50|1.02|
73957751|NCT00383188|147451051|SUPERIORITY||LSM Difference|-0.136|STANDARD_ERROR_OF_MEAN|0.102||0.1836|TWO_SIDED|95.0|-0.336|0.065|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.065|-0.336|0.1836
74008022|NCT02137512|147566397|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008023|NCT02137512|147566397|SUPERIORITY|||||||0.2||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.20
74008024|NCT02137512|147566398|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
74008025|NCT02137512|147566398|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008026|NCT02137512|147566398|SUPERIORITY|||||||0.49||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.49
74008027|NCT02137512|147566399|SUPERIORITY|||||||0.009||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.009
74008028|NCT02137512|147566399|SUPERIORITY|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.14
74008029|NCT02137512|147566399|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
74008030|NCT02137512|147566400|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
74008031|NCT02137512|147566400|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
74008032|NCT02137512|147566400|SUPERIORITY|||||||0.18||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.18
74008033|NCT02137512|147566401|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
74008034|NCT02137512|147566401|SUPERIORITY|||||||0.54||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.54
73957752|NCT00383188|147451051|SUPERIORITY||LSM Difference|0.078|STANDARD_ERROR_OF_MEAN|0.105||0.4577|TWO_SIDED|95.0|-0.128|0.284|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.284|-0.128|0.4577
73957753|NCT00383188|147451051|SUPERIORITY||LSM Difference|0.082|STANDARD_ERROR_OF_MEAN|0.092||0.3692|TWO_SIDED|95.0|-0.098|0.262|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.262|-0.098|0.3692
73957754|NCT00383188|147451051|SUPERIORITY||LSM Difference|0.065|STANDARD_ERROR_OF_MEAN|0.09||0.4677|TWO_SIDED|95.0|-0.111|0.241|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.241|-0.111|0.4677
73957755|NCT00383188|147451051|SUPERIORITY||LSM Difference|0.1|STANDARD_ERROR_OF_MEAN|0.106||0.3427|TWO_SIDED|95.0|-0.107|0.307|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.307|-0.107|0.3427
73957756|NCT00383188|147451051|SUPERIORITY||LSM Difference|0.135|STANDARD_ERROR_OF_MEAN|0.108||0.212|TWO_SIDED|95.0|-0.077|0.347|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.347|-0.077|0.2120
73957757|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.587|STANDARD_ERROR_OF_MEAN|0.337||0.0815|TWO_SIDED|95.0|-1.248|0.074|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.074|-1.248|0.0815
73957758|NCT00383188|147451052|SUPERIORITY||LSM Difference|-1.057|STANDARD_ERROR_OF_MEAN|0.331||0.0015|TWO_SIDED|95.0|-1.707|-0.407|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.407|-1.707|0.0015
73957759|NCT00383188|147451052|SUPERIORITY||LSM Difference|-1.107|STANDARD_ERROR_OF_MEAN|0.385||0.0042|TWO_SIDED|95.0|-1.863|-0.351|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.351|-1.863|0.0042
73957760|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.842|STANDARD_ERROR_OF_MEAN|0.398||0.0348|TWO_SIDED|95.0|-1.624|-0.06|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.060|-1.624|0.0348
73957761|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.442|STANDARD_ERROR_OF_MEAN|0.332||0.1843|TWO_SIDED|95.0|-1.095|0.211|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.211|-1.095|0.1843
73957762|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.582|STANDARD_ERROR_OF_MEAN|0.327||0.076|TWO_SIDED|95.0|-1.225|0.061|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.061|-1.225|0.0760
73878650|NCT04972162|147296945|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.38||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Ease of Communication Subscale (EC)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.38
73878651|NCT04972162|147296945|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.79||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Background Noise Subscale (BN)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.79
73878652|NCT04972162|147296945|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.51||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Reverberant Room Subscale (RV)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.51
73957763|NCT00383188|147451052|SUPERIORITY||LSM Difference|-1.019|STANDARD_ERROR_OF_MEAN|0.382||0.0078|TWO_SIDED|95.0|-1.769|-0.27|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.270|-1.769|0.0078
73957764|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.517|STANDARD_ERROR_OF_MEAN|0.395||0.1905|TWO_SIDED|95.0|-1.292|0.258|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.258|-1.292|0.1905
74008035|NCT02137512|147566401|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
74008036|NCT02137512|147566402|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
74008037|NCT02137512|147566402|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008038|NCT02137512|147566402|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
74008039|NCT02137512|147566403|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008040|NCT02137512|147566403|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008041|NCT02137512|147566403|SUPERIORITY|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.52
74008042|NCT02137512|147566404|SUPERIORITY|||||||0.13||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.13
74008043|NCT02137512|147566404|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008044|NCT02137512|147566404|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008045|NCT02137512|147566405|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008046|NCT02137512|147566405|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008047|NCT02137512|147566405|SUPERIORITY|||||||0.41||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.41
74008048|NCT02137512|147566406|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74091592|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.11|||||TWO_SIDED|95.0|1.21|3.68|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 17F||3.68|1.21|
74091593|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.87|||||TWO_SIDED|95.0|1.64|5.03|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 17F||5.03|1.64|
73957765|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.149|STANDARD_ERROR_OF_MEAN|0.332||0.6552|TWO_SIDED|95.0|-0.801|0.504|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.504|-0.801|0.6552
73957766|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.327||0.0281|TWO_SIDED|95.0|-1.363|-0.078|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.078|-1.363|0.0281
74008049|NCT02137512|147566406|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74091594|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.65|||||TWO_SIDED|95.0|0.93|2.93|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 20A||2.93|0.93|
74091595|NCT04168190|147737016|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.92|||||TWO_SIDED|95.0|1.07|3.43|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 20A||3.43|1.07|
73957767|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.382||0.0263|TWO_SIDED|95.0|-1.599|-0.1|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.100|-1.599|0.0263
73957768|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.429|STANDARD_ERROR_OF_MEAN|0.395||0.2772|TWO_SIDED|95.0|-1.204|0.346|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.346|-1.204|0.2772
73957769|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.024|STANDARD_ERROR_OF_MEAN|0.332||0.9433|TWO_SIDED|95.0|-0.676|0.629|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.629|-0.676|0.9433
73957770|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.768|STANDARD_ERROR_OF_MEAN|0.327||0.193|TWO_SIDED|95.0|-1.41|-0.125|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.125|-1.410|0.193
73957771|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.763|STANDARD_ERROR_OF_MEAN|0.382||0.461|TWO_SIDED|95.0|-1.512|-0.013|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.013|-1.512|0.461
73957772|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.254|STANDARD_ERROR_OF_MEAN|0.395||0.52|TWO_SIDED|95.0|-1.029|0.521|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.521|-1.029|0.5200
73957773|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.476|STANDARD_ERROR_OF_MEAN|0.332||0.1526|TWO_SIDED|95.0|-1.129|0.177|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.177|-1.129|0.1526
73957774|NCT00383188|147451052|SUPERIORITY||LSM Difference|-1.095|STANDARD_ERROR_OF_MEAN|0.327||0.0009|TWO_SIDED|95.0|-1.738|-0.453|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.453|-1.738|0.0009
73957775|NCT00383188|147451052|SUPERIORITY||LSM Difference|-0.523|STANDARD_ERROR_OF_MEAN|0.382||0.1711|TWO_SIDED|95.0|-1.273|0.227|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.227|-1.273|0.1711
73878653|NCT04972162|147296945|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.44|||<|0.0001|TWO_SIDED|95.0|-4.3|5.2||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Ease of Communication Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||5.2|-4.3|<0.0001
74008050|NCT02137512|147566406|SUPERIORITY|||||||0.12||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.12
74008051|NCT02137512|147566407|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
74008052|NCT02137512|147566407|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008053|NCT02137512|147566407|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
74008054|NCT02137512|147566408|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008055|NCT02137512|147566408|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
74008056|NCT02137512|147566408|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
74008057|NCT02137512|147566409|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008058|NCT02137512|147566409|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008059|NCT02137512|147566409|SUPERIORITY|||||||0.11||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.11
74008060|NCT02137512|147566410|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
74008061|NCT02137512|147566410|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
74008062|NCT02137512|147566410|SUPERIORITY|||||||0.61||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.61
74008063|NCT02137512|147566411|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008064|NCT02137512|147566411|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008065|NCT02137512|147566411|SUPERIORITY|||||||0.29||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.29
74008066|NCT02137512|147566412|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008067|NCT02137512|147566412|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
74008068|NCT02137512|147566412|SUPERIORITY||||||>|0.99||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||>0.99
74008069|NCT02137512|147566413|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
74008070|NCT02137512|147566413|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008071|NCT02137512|147566413|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
74008072|NCT02137512|147566414|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
74008073|NCT02137512|147566414|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008074|NCT02137512|147566414|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008075|NCT02137512|147566415|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008076|NCT02137512|147566415|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008077|NCT02137512|147566415|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
74008078|NCT02137512|147566416|SUPERIORITY|||||||0.04||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.04
74008079|NCT02137512|147566416|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008080|NCT02137512|147566416|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008081|NCT02137512|147566417|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
74008082|NCT02137512|147566417|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008083|NCT02137512|147566417|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008084|NCT02137512|147566418|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 1 sided|||||||<0.001
74008085|NCT02137512|147566418|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008086|NCT02137512|147566418|SUPERIORITY|||||||0.53||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.53
74008087|NCT02137512|147566419|SUPERIORITY|||||||0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.05
74008088|NCT02137512|147566419|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74008089|NCT02137512|147566419|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
74091729|NCT04620135|147737065|SUPERIORITY||The least squares (LS) mean difference|-1.74|STANDARD_ERROR_OF_MEAN|0.221|<|1e-05|TWO_SIDED|95.0|-2.17|-1.31||Analyzed as ANCOVA with mean diurnal IOP at Week 4 as the response, baseline mean diurnal IOP as a covariate, and treatment as a main effect, using the ITT population with MCMC and regression-based multiple imputation to impute missing data.|ANCOVA||||The primary analysis of the primary endpoint employed an analysis of covariance (ANCOVA) with mean diurnal IOP at Week 4 as the response, baseline mean diurnal IOP as a covariate, and treatment as a main effect, using the ITT population with Markov Chain Monte Carlo (MCMC) and regression based multiple imputation (MI) techniques to impute missing data. The least squares (LS) mean difference (netarsudil - ripasudil) was presented with a 2-sided p-value and 95% confidence intervals (CIs). A success criterion for the superiority of netarsudil to ripasudil was defined as the 2-sided p value ≤ 0.05 for testing the difference (netarsudil QD - ripasudil BID) to 0 and the point estimate of the LS mean difference of \< 0.|-1.31|-2.17|<0.00001
74091730|NCT02666352|147737068|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.89|2.31||||||||2.31|0.89|
74091731|NCT02666352|147737068|OTHER||Geometric least-squares mean ratio|2.15|||||TWO_SIDED|90.0|1.33|3.47||||||||3.47|1.33|
74091732|NCT02666352|147737069|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.88|2.31||||||||2.31|0.88|
74091733|NCT02666352|147737069|OTHER||Geometric least-squares mean ratio|2.15||||||90.0|1.33|3.48||||||||3.48|1.33|
74091734|NCT02666352|147737070|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.89|2.31||||||||2.31|0.89|
74091735|NCT02666352|147737070|OTHER||Geometric least-squares mean ratio|2.15|||||TWO_SIDED|90.0|1.33|3.47||||||||3.47|1.33|
74091736|NCT02666352|147737071|OTHER||Geometric least-squares mean ratio|1.32|||||TWO_SIDED|90.0|0.81|2.15||||||||2.15|0.81|
74091737|NCT02666352|147737071|OTHER||Geometric least-squares mean ratio|1.81|||||TWO_SIDED|90.0|1.11|2.94||||||||2.94|1.11|
74091738|NCT02666352|147737077|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.58|1.1||||||||1.10|0.58|
74091739|NCT02666352|147737077|OTHER||Geometric least-squares mean ratio|0.84|||||TWO_SIDED|90.0|0.61|1.16||||||||1.16|0.61|
74091740|NCT02666352|147737078|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.58|1.11||||||||1.11|0.58|
74091741|NCT02666352|147737078|OTHER||Geometric least-squares mean ratio|0.86||||||90.0|0.62|1.18||||||||1.18|0.62|
74091742|NCT02666352|147737079|OTHER||Geometric least-squares mean ratio|0.77|||||TWO_SIDED|90.0|0.57|1.05||||||||1.05|0.57|
74091743|NCT02666352|147737079|OTHER||Geometric least-squares mean ratio|0.73|||||TWO_SIDED|90.0|0.54|0.99||||||||0.99|0.54|
74091744|NCT02666352|147737080|OTHER||Geometric least-squares mean ratio|0.83|||||TWO_SIDED|90.0|0.61|1.13||||||||1.13|0.61|
74091745|NCT02666352|147737080|OTHER||Geometric least-squares mean ratio|0.75|||||TWO_SIDED|90.0|0.55|1.01||||||||1.01|0.55|
74091746|NCT02666352|147737081|OTHER||Geometric least-squares mean ratio|0.83|||||TWO_SIDED|90.0|0.6|1.15||||||||1.15|0.60|
74091747|NCT02666352|147737081|OTHER||Geometric least-squares mean ratio|0.82|||||TWO_SIDED|90.0|0.59|1.13||||||||1.13|0.59|
74091748|NCT02666352|147737085|OTHER||Geometric least-squares mean ratio|0.68|||||TWO_SIDED|90.0|0.52|0.9||||||||0.90|0.52|
74091749|NCT02666352|147737085|OTHER||Geometric least-squares mean ratio|0.66|||||TWO_SIDED|90.0|0.5|0.86||||||||0.86|0.50|
74091750|NCT02666352|147737086|OTHER||Geometric least-squares mean ratio|0.64|||||TWO_SIDED|90.0|0.48|0.86||||||||0.86|0.48|
74091751|NCT02666352|147737086|OTHER||Geometric least-squares mean ratio|0.61||||||90.0|0.46|0.82||||||||0.82|0.46|
74091752|NCT02666352|147737087|OTHER||Geometric least-squares mean ratio|0.79|||||TWO_SIDED|90.0|0.62|1.01||||||||1.01|0.62|
74091753|NCT02666352|147737087|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.63|1.02||||||||1.02|0.63|
74091754|NCT02666352|147737088|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.61|1.05||||||||1.05|0.61|
74091755|NCT02666352|147737088|OTHER||Geometric least-squares mean ratio|0.78|||||TWO_SIDED|90.0|0.6|1.03||||||||1.03|0.60|
74091756|NCT02666352|147737089|OTHER||Geometric least-squares mean ratio|0.71|||||TWO_SIDED|90.0|0.57|0.89||||||||0.89|0.57|
74091757|NCT02666352|147737089|OTHER||Geometric least-squares mean ratio|0.73|||||TWO_SIDED|90.0|0.58|0.91||||||||0.91|0.58|
74091758|NCT02666352|147737092|OTHER||Geometric least-squares mean ratio (GMR)|1.16|||||TWO_SIDED|90.0|0.85|1.58||||||||1.58|0.85|
74091759|NCT02666352|147737092|OTHER||Geometric least-squares mean ratio|1.36|||||TWO_SIDED|90.0|1.0|1.85||||||||1.85|1.00|
74091760|NCT02666352|147737093|OTHER||Geometric least-squares mean ratio|1.24|||||TWO_SIDED|90.0|0.91|1.68||||||||1.68|0.91|
74091761|NCT02666352|147737093|OTHER||Geometric least-squares mean ratio|1.58||||||90.0|1.17|2.14||||||||2.14|1.17|
74091762|NCT02666352|147737094|OTHER||Geometric least-squares mean ratio|0.89|||||TWO_SIDED|90.0|0.6|1.33||||||||1.33|0.60|
74091763|NCT02666352|147737094|OTHER||Geometric least-squares mean ratio|0.9|||||TWO_SIDED|90.0|0.6|1.34||||||||1.34|0.60|
74091764|NCT02666352|147737095|OTHER||Geometric least-squares mean ratio|0.77|||||TWO_SIDED|90.0|0.45|1.3||||||||1.30|0.45|
74091765|NCT02666352|147737095|OTHER||Geometric least-squares mean ratio|0.68|||||TWO_SIDED|90.0|0.4|1.14||||||||1.14|0.40|
74091766|NCT02666352|147737096|OTHER||Geometric least-squares mean ratio|1.2|||||TWO_SIDED|90.0|0.9|1.6||||||||1.60|0.90|
74091767|NCT02666352|147737096|OTHER||Geometric least-squares mean ratio|1.41|||||TWO_SIDED|90.0|1.06|1.87||||||||1.87|1.06|
74091768|NCT00876018|147737144|OTHER|||||||0.004||95.0|||||Mann Whitney U test|||||||0.004
74091769|NCT00876018|147737144|OTHER|||||||0.147||95.0|||||Mann Whitney U test|||||||0.147
74091770|NCT00876018|147737145|OTHER|||||||0.002||95.0|||||Mann Whitney U test|||||||0.002
74091771|NCT00876018|147737145|OTHER|||||||0.003||95.0|||||Mann Whitney U test|||||||0.003
74091772|NCT00876018|147737146|OTHER|||||||0.153||95.0|||||Mann Whitney U test|||||||0.153
74091773|NCT00876018|147737146|OTHER|||||||0.903||95.0|||||Mann Whitney U test|||||||0.903
74091774|NCT00876018|147737147|OTHER|||||||0.143||95.0|||||Mann Whitney U test|||||||0.143
74091775|NCT00876018|147737147|OTHER|||||||0.678||95.0|||||Mann Whitney U test|||||||0.678
74091776|NCT01189500|147737173|SUPERIORITY_OR_OTHER||ratio of adjusted means|100.69|||||TWO_SIDED|90.0|96.7|104.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||104.85|96.70|
74091777|NCT01189500|147737175|SUPERIORITY_OR_OTHER||ratio of adjusted means|99.44|||||TWO_SIDED|90.0|94.02|105.17|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||105.17|94.02|
74091778|NCT01189500|147737180|SUPERIORITY_OR_OTHER||ratio of adjusted means|92.04|||||TWO_SIDED|90.0|84.71|100.0|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||100.00|84.71|
74091779|NCT01189500|147737186|SUPERIORITY_OR_OTHER||ratio of adjusted means|112.07|||||TWO_SIDED|90.0|107.44|116.9|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||116.90|107.44|
74091780|NCT01189500|147737191|SUPERIORITY_OR_OTHER||ratio of adjusted means|105.6|||||TWO_SIDED|90.0|99.74|111.81|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||111.81|99.74|
74091781|NCT01189500|147737192|SUPERIORITY_OR_OTHER||ratio of adjusted means|108.47|||||TWO_SIDED|90.0|103.51|113.67|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||113.67|103.51|
74091782|NCT04764630|147737201|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.95||||0.002|ONE_SIDED|95.6|1.28|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 10-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (10, 12.5, and 15 min). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (1 every 2.5 min) compared to the 2 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.28|0.002
74091783|NCT04764630|147737202|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.98||||0.018|ONE_SIDED|95.6|1.03|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 4.5-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (2 doses every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (4.5, 7, and 10 minutes). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (2 doses every 2.5 min) compared to the 2 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.03|0.018
74091784|NCT04764630|147737203|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.69||||0.013|ONE_SIDED|95.6|1.06|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 4.5-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (2 doses every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (4.5, 7, and 10 minutes). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (2 doses every 2.5 min) compared to the 4 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.06|0.013
74091785|NCT04764630|147737204|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.89||||0.1|TWO_SIDED|90.0|0.78|1.0|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||1.00|0.78|0.10
74091786|NCT04764630|147737204|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.77||||0.018|TWO_SIDED|90.0|0.65|0.92|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.92|0.65|0.018
73878654|NCT04972162|147296945|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.97|||<|0.0001|TWO_SIDED|95.0|-5.3|7.2||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Background Noise Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||7.2|-5.3|<0.0001
73878655|NCT04972162|147296945|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.98|||<|0.0001|TWO_SIDED|95.0|-4.6|6.5||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Reverberant Room Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||6.5|-4.6|<0.0001
73878656|NCT01928927|147296946|SUPERIORITY||Theta statistic|0.5||||0.97|TWO_SIDED|95.0|0.26|0.73||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50||0.73|0.26|0.97
73878657|NCT01928927|147296947|SUPERIORITY||Theta statistic|0.57||||0.61|TWO_SIDED|95.0|0.31|0.83||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50||0.83|0.31|0.61
73878658|NCT00383552|147297014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
73878659|NCT00383552|147297015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
73878660|NCT00383552|147297017|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
73878661|NCT00383552|147297018|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
73878662|NCT00383552|147297019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||Longitudinal Model|||||||0.073
74039885|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0005|TWO_SIDED|95.0|-0.88|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-0.88|0.0005
73878663|NCT00383552|147297020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||||||BMI 25 to \<30|ANCOVA|||||||0.015
73878664|NCT00383552|147297020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||BMI less than 25 and for BMI 30 or more|ANCOVA|||||||<0.001
73878665|NCT03692208|147297022|OTHER|Quantitative outcomes from chart and survey data were summarized by basic descriptive statistics.|||||<|0.01||||||P-values were calculated. Only P values of \<0.05 were considered statistically significant.|Chi-squared|Chi-squared tests, Fisher's Exact tests, two-sample t-tests, and paired two-sample t-tests were utilized to assess the outcomes between study arms.||||||<0.01
73878666|NCT00702468|147297041|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.335||||0.013|TWO_SIDED|90.0|0.162|0.691|||Chi-squared|||||0.691|0.162|0.013
73878667|NCT00702468|147297042|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.21||||0.72|TWO_SIDED|90.0|-1.22|0.79|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex|||0.79|-1.22|0.720
73878668|NCT00702468|147297043|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.53||||0.86|TWO_SIDED|90.0|-4.68|5.74|||ANCOVA|||||5.74|-4.68|0.86
73878669|NCT00702468|147297045|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.78||||0.81|TWO_SIDED|90.0|-14.52|10.96|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex|It is important to emphasise that only four placebo subjects were included in the analysis and 11 of the Sativex subjects - this sample size is too small for a meaningful comparison between treatments. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.||10.96|-14.52|0.81
74091787|NCT04764630|147737204|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.87||||0.12|TWO_SIDED|90.0|0.75|1.01|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||1.01|0.75|0.12
74091788|NCT04764630|147737205|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.83||||0.002|TWO_SIDED|90.0|0.76|0.91|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.91|0.76|0.002
74091789|NCT04764630|147737205|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.75|||<|0.001|TWO_SIDED|90.0|0.7|0.81|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.81|0.70|<0.001
74091790|NCT04764630|147737205|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.91||||0.014|TWO_SIDED|90.0|0.85|0.97|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.97|0.85|0.014
74091791|NCT04764630|147737206|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.82||||0.001|TWO_SIDED|90.0|0.75|0.89|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.89|0.75|0.001
74091792|NCT04764630|147737206|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.74|||<|0.001|TWO_SIDED|90.0|0.69|0.8|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.80|0.69|<0.001
73878670|NCT00702468|147297046|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.64||||0.271|TWO_SIDED|90.0|-1.6|0.33|||ANCOVA||A negative difference indicates the comparison is in favour of Sativex|||0.33|-1.60|0.271
73878671|NCT00702468|147297047|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.562||||0.017|TWO_SIDED|90.0|1.585|13.997|||Regression, Logistic|||||13.997|1.585|0.017
73878672|NCT00702468|147297048|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.55||||0.0011|TWO_SIDED|90.0|3.942|118.773|||Regression, Logistic|||||118.773|3.942|0.0011
73878673|NCT00702468|147297049|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.444||||0.1151|TWO_SIDED|90.0|0.948|13.718|||Regression, Logistic|||||13.718|0.948|0.1151
73878674|NCT00467740|147297079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.045||0.0754||95.0|-0.008|0.167|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.167|-0.008|0.0754
73878675|NCT00467740|147297079|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.045||0.0571||95.0|-0.003|0.174|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.174|-0.003|0.0571
73878676|NCT00467740|147297079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.045||0.0906||95.0|-0.012|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.164|-0.012|0.0906
73878677|NCT00467740|147297079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.044||0.0011||95.0|0.059|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.234|0.059|0.0011
73878678|NCT00467740|147297080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.238|STANDARD_ERROR_OF_MEAN|7.843||0.0393||95.0|0.801|31.675|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||31.675|0.801|0.0393
73878679|NCT00467740|147297080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.878|STANDARD_ERROR_OF_MEAN|7.875||0.0005||95.0|12.379|43.378|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||43.378|12.379|0.0005
74091793|NCT04764630|147737206|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.91||||0.014|TWO_SIDED|90.0|0.85|0.96|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.96|0.85|0.014
74091794|NCT01144364|147737223|SUPERIORITY_OR_OTHER|||||||0.254|||||||Log Rank|||Difference between treatment arms||||0.254
73878680|NCT00467740|147297080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.072|STANDARD_ERROR_OF_MEAN|7.906|<|0.0001||95.0|20.512|51.633|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||51.633|20.512|<0.0001
73878681|NCT00467740|147297080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.943|STANDARD_ERROR_OF_MEAN|7.848|<|0.0001||95.0|27.498|58.389|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||58.389|27.498|<0.0001
73878682|NCT00467740|147297081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.044||0.1264||95.0|-0.019|0.154|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.154|-0.019|0.1264
73878683|NCT00467740|147297081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.044||0.0232||95.0|0.014|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.188|0.014|0.0232
73878684|NCT00467740|147297081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.044||0.0106||95.0|0.027|0.2|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.027|0.0106
73878685|NCT00467740|147297081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.044||0.0001||95.0|0.087|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.260|0.087|0.0001
73878686|NCT00467740|147297082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.048||0.0329||95.0|0.008|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.198|0.008|0.0329
73878687|NCT00467740|147297082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.048||0.0666||95.0|-0.006|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.184|-0.006|0.0666
73878688|NCT00467740|147297082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.048||0.3738||95.0|-0.052|0.137|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.137|-0.052|0.3738
74091795|NCT01144364|147737225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.105|TWO_SIDED|95.0|0.31|1.12||Overall DFS|Cox proportional-hazards|Adjusted for randomization stratum and the known prognostic factors.||||1.12|0.31|0.105
74091796|NCT01144364|147737226|SUPERIORITY_OR_OTHER|||||||0.751|||||||Log Rank|||||||0.751
74091797|NCT01144364|147737227|SUPERIORITY_OR_OTHER|||||||0.751|||||||Log Rank|||||||0.751
74091798|NCT01144364|147737229|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.079|TWO_SIDED|95.0|0.38|1.05|||Cox proportional-hazards|||Analysis of overall PFS with Cox proportional-hazards model adjusted for the randomization stratum and the known prognostic factors.||1.05|0.38|0.079
74091799|NCT01144364|147737232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.103|TWO_SIDED|95.0|0.4|1.09||Univariate analysis|Regression, Cox|Cox model stratified for the stratification groups.||||1.09|0.40|0.103
74091800|NCT01144364|147737232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.071|TWO_SIDED|95.0|0.37|1.04||Multivariate analysis|Regression, Cox|Adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, FL International prognostic index (FLIPI) score.||||1.04|0.37|0.071
74091801|NCT01144364|147737233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.084|TWO_SIDED|95.0|0.39|1.06||Univariate analysis|Fine and Gray model|Fine and Gray model stratified for the stratification groups.||||1.06|0.39|0.084
74091802|NCT01144364|147737233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.052|TWO_SIDED|95.0|0.38|1.0|||Fine and Gray model|Fine and Gray model adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, and FLIPI score||||1.00|0.38|0.052
74091803|NCT01635062|147737234|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.3||||0.69|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would lower plasma renin activity (PRA), when sodium restricted, when compared to placebo.||||0.69
74091804|NCT01635062|147737235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.8||||0.89|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would raise renal plasma flow, when sodium loaded, when compared to placebo.||||0.89
74091805|NCT01635062|147737236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0||||0.8|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would lower urine protein, when sodium loaded, when compared to placebo.||||0.80
74091806|NCT01301508|147737241|SUPERIORITY_OR_OTHER|||||||0.008||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2898 Topical Ointment, 1% + Ointment Vehicle group.|Two-sided sign test|||||||0.008
74091807|NCT01301508|147737241|SUPERIORITY_OR_OTHER|||||||0.017||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2728 Topical Ointment, 2% + Ointment Vehicle group.|Two-sided sign test|||||||0.017
74091808|NCT03123861|147737261|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
74091809|NCT03123861|147737262|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
74091810|NCT03123861|147737263|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
74091811|NCT03123861|147737264|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
74091812|NCT03188666|147737271|SUPERIORITY||Least Square Mean Difference|-24.6||||0.0741|TWO_SIDED|95.0|-51.8|2.5|||ANCOVA|||||2.5|-51.8|0.0741
74091813|NCT03188666|147737272|SUPERIORITY||Least Square Mean Difference|-24.9||||0.3726|TWO_SIDED|95.0|-80.8|30.9|||Mixed Model with Repeated Measure (MMRM)|||||30.9|-80.8|0.3726
74091814|NCT03188666|147737273|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared number of new lesions per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
74091815|NCT03188666|147737274|SUPERIORITY||Least Square Mean Difference|-25.6||||0.0756|TWO_SIDED|95.0|-53.9|2.8|||ANCOVA|||||2.8|-53.9|0.0756
74091816|NCT03188666|147737275|SUPERIORITY||Least Square Mean Difference|-27.8||||0.3407|TWO_SIDED|95.0|-86.1|30.5|||Mixed Model with Repeated Measure (MMRM)|||||30.5|-86.1|0.3407
74091817|NCT03188666|147737276|SUPERIORITY||Least Square Mean Difference|-0.34||||0.2656|TWO_SIDED|95.0|-0.96|0.27|||ANCOVA|||||0.27|-0.96|0.2656
74091818|NCT03188666|147737277|SUPERIORITY||Least Square Mean Difference|-0.36||||0.2651|TWO_SIDED|95.0|-1.01|0.29|||ANCOVA|||||0.29|-1.01|0.2651
74091819|NCT03188666|147737284|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared number of new lesions per participant by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
74091820|NCT03188666|147737285|SUPERIORITY|||||||0.0027||||||Week 56 vs. Week 28|McNemar|||Compared percent of participants with new lesions by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0027
74091821|NCT03188666|147737286|SUPERIORITY|||||||0.0047||||||Week 56 vs. Week 28|McNemar|||Compared percent of participants with new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0047
74091822|NCT03188666|147737289|SUPERIORITY|||||||0.3663||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.3663
74091823|NCT03188666|147737290|SUPERIORITY|||||||0.001||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.0010
74091824|NCT03188666|147737296|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared total new lesion volume per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
74091825|NCT03188666|147737297|SUPERIORITY|||||||0.0273||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared total lesion activity per participant in new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0273
74091826|NCT03188666|147737298|SUPERIORITY|||||||0.2123||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.2123
74091827|NCT03188666|147737299|SUPERIORITY|||||||0.1528||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.1528
74091828|NCT03696953|147737312|OTHER|t test comparing||||||0.05|||||||t-test, 2 sided|||||||0.05
74091829|NCT03696953|147737313|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
74091830|NCT03696953|147737313|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
74091831|NCT03696953|147737314|OTHER|T test||||||0.01|||||||t-test, 2 sided|||Comparison of 36 week AP-GI-SA Scores between probiotic and placebo groups at 36 weeks||||0.01
74091832|NCT03696953|147737315|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
74091833|NCT03696953|147737316|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
74091834|NCT02766374|147737388|SUPERIORITY||||||>|0.1|||||||GEE regression|||||||>0.1
74091835|NCT00292188|147737423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.01||95.0|-1.09|-0.15|||ANCOVA|ANCOVA adjusted for treatment group, baseline mean pain score and pooled country||The study is powered to detect a clinically significant difference of 1 between treatment groups in the weekly mean pain score. Null hypothesis was that there was no difference in weekly mean pain scores between pregabalin and placebo.||-0.15|-1.09|0.010
74091836|NCT00292188|147737424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.39||0.031||95.0|-1.6|-0.08|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.08|-1.60|0.031
74009274|NCT04667377|147569396|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Emax1 model fit|Model Assumption: 90% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
74009275|NCT04667377|147569396|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Emax2 model fit|Model Assumption: 70% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
74009276|NCT04667377|147569396|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Sigmoid Emax model fit|Model Assumption: 50% of maximum effect achieved at dose 2.4 mg, 90% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
74009277|NCT04667377|147569396|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-3.37|STANDARD_ERROR_OF_MEAN|1.5||0.0257|TWO_SIDED|95.0|-6.33|-0.41||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.41|-6.33|0.0257
74009278|NCT04667377|147569396|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-9.69|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-12.57|-6.81||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation as used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-6.81|-12.57|<.0001
74009279|NCT04667377|147569396|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-10.4|STANDARD_ERROR_OF_MEAN|1.48|<|0.0001|TWO_SIDED|95.0|-13.32|-7.49||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.49|-13.32|<.0001
74009280|NCT04667377|147569396|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.12|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-15.0|-9.24||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation will be used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-9.24|-15.00|<.0001
74091837|NCT00292188|147737425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.32||0.003||95.0|-1.61|-0.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.33|-1.61|0.003
74091838|NCT00292188|147737426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|1.0||0.099||95.0|-3.69|0.32|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||0.32|-3.69|0.099
74091839|NCT00292188|147737427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|1.03||0.819||95.0|-1.87|2.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||2.34|-1.87|0.819
74091840|NCT00292188|147737428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.099||95.0|-0.56|0.05|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 1||0.05|-0.56|0.099
74091841|NCT00292188|147737428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.18||0.15||95.0|-0.62|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 2: FAS||0.10|-0.62|0.150
74091842|NCT00292188|147737428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.2||0.01||95.0|-0.93|-0.13|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 3: FAS||-0.13|-0.93|0.010
74091843|NCT00292188|147737428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.21||0.137||95.0|-0.74|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 4: FAS||0.10|-0.74|0.137
74091844|NCT00292188|147737428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.22||0.041||95.0|-0.9|-0.02|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 5: FAS||-0.02|-0.90|0.041
74091845|NCT00292188|147737428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.009||95.0|-1.03|-0.15|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 6: FAS||-0.15|-1.03|0.009
74091846|NCT00292188|147737428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.25||0.035||95.0|-1.01|-0.04|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 7: FAS||-0.04|-1.01|0.035
74091847|NCT00292188|147737428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.019||95.0|-1.1|-0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 8: FAS||-0.10|-1.10|0.019
74091848|NCT00292188|147737429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.032||95.0|1.05|3.21|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||30% responder||3.21|1.05|0.032
74091849|NCT00292188|147737429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.78||||0.088||95.0|0.92|3.46|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||50% responder||3.46|0.92|0.088
74091850|NCT00292188|147737430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.23||0.001||95.0|-1.25|-0.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.34|-1.25|0.001
74091851|NCT00292188|147737431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|2.62||0||95.0|-15.89|-5.55|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Disturbance||-5.55|-15.89|0.000
74091852|NCT00292188|147737431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|2.71||0.7||95.0|-4.3|6.4|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Snoring||6.40|-4.30|0.700
74091853|NCT00292188|147737431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.95|STANDARD_ERROR_OF_MEAN|2.88||0.04||95.0|-11.62|-0.28|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Awaken Short of Breath/Headache||-0.28|-11.62|0.040
74091854|NCT00292188|147737431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.42||0.846||95.0|-0.92|0.76|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Quantity||0.76|-0.92|0.846
74091855|NCT00292188|147737431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.63|STANDARD_ERROR_OF_MEAN|3.27||0.001||95.0|4.19|17.07|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Adequacy||17.07|4.19|0.001
74091856|NCT00292188|147737431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|2.34||0.324||95.0|-2.3|6.92|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Somnolence||6.92|-2.30|0.324
74091857|NCT00292188|147737431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.52|STANDARD_ERROR_OF_MEAN|2.63||0||95.0|-14.71|-4.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-6||-4.33|-14.71|0.000
74091858|NCT00292188|147737431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.54|STANDARD_ERROR_OF_MEAN|2.02||0||95.0|-11.52|-3.56|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-9||-3.56|-11.52|0.000
74091859|NCT00292188|147737432|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.267||95.0|0.76|2.64|||Regression, Logistic|Logistic regression adjusted for treatment group, baseline score and pooled country.||||2.64|0.76|0.267
74091860|NCT00292188|147737440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.84|STANDARD_ERROR_OF_MEAN|2.25||0.09||95.0|-8.28|0.61|||ANCOVA|||||0.61|-8.28|0.090
74091861|NCT00824616|147737450|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.745|TWO_SIDED|95.0|-0.81|0.58|||Longitudinal Data Analysis (LDA) model|||||0.58|-0.81|0.745
74091862|NCT00824616|147737451|SUPERIORITY_OR_OTHER||Proportions|5.9||||0.537|TWO_SIDED|95.0|-13.7|25.4|||Miettinen & Nurminen method|||Between-treatment difference (MK-0941 group minus Placebo group) in the percentage of participants who experienced one or more episodes of hypoglycemia.||25.4|-13.7|0.537
74091863|NCT01796912|147737462|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
74091864|NCT01796912|147737463|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74091865|NCT01796912|147737464|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
74091866|NCT01796912|147737465|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||||||0.016
74091867|NCT01796912|147737466|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74091868|NCT01796912|147737467|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74091869|NCT01796912|147737468|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
74091870|NCT02920918|147737480|SUPERIORITY|||||||0.083|||||||ANOVA|||We expected a baseline peak oxygen consumption (VO2) of 14.5 mL/kg/min. A sample size of 40 patients per group (total of 80 patients) provided sufficient power to detect a mean difference in the interval change in peak VO2 of 1.50±1.76 mL/kg/min (primary endpoint) expected with Canagliflozin compared to Sitagliptin, which we predict to have no significant effect on peak VO2 (0±1.76 mL/kg/min).||||0.083
74091871|NCT02920918|147737481|SUPERIORITY|||||||0.51|||||||ANOVA|||||||0.51
74091872|NCT03537274|147737482|SUPERIORITY|||||||0.078|||||||Chi-squared|||||||0.078
74091873|NCT03537274|147737482|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.005
74091874|NCT03537274|147737482|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
74091875|NCT03537274|147737483|SUPERIORITY|||||||0.128|||||||Chi-squared|||||||0.128
74091876|NCT03537274|147737483|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74091877|NCT03537274|147737483|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74091878|NCT00974974|147737484|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<.0001
74091879|NCT00974974|147737485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<.0001
74091880|NCT02836496|147737556|SUPERIORITY|||||||0.002||||||Cochran-Mantel-Haenszel test stratified by Baseline oral corticosteroid (OCS) (0-\<=20 mg per day and \>20mg perday prednisone or equivalent) and region|Cochran-Mantel-Haenszel|||||||0.002
74091881|NCT02836496|147737556|SUPERIORITY||Odds Ratio (OR)|0.28||||0.003|TWO_SIDED|95.0|0.12|0.64|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region.|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% confidence interval (CI) has been presented. Odds ratio \<1 indicated lower odds of HES flare with Mepolizumab compared with placebo.|||0.64|0.12|0.003
74091882|NCT02836496|147737557|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline OCS (0-\<=20 mg per day and \>20mg perday prednisone or equivalent) and region||||||0.020
74091883|NCT02836496|147737557|SUPERIORITY||Odds Ratio (OR)|0.33||||0.022|TWO_SIDED|95.0|0.13|0.85|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% CI has been presented. Odds ratio \<1 indicated lower odds of HES flare with Mepolizumab compared with placebo.|||0.85|0.13|0.022
74091884|NCT02836496|147737558|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.002|TWO_SIDED|95.0|0.18|0.67||Cox proportional hazards regression analysis adjusted for Baseline OCS dose and region.|Regression, Cox||Treatment comparison between placebo and mepolizumab 300 mg using hazards ratio and its corresponding 95% CI has been presented. Hazard ratio \<1 indicated a lower risk of HES flare with Mepolizumab compared with Placebo.|||0.67|0.18|0.002
74091885|NCT02836496|147737559|SUPERIORITY||Rate Ratio|0.34||||0.002|TWO_SIDED|95.0|0.19|0.63|||Wilcoxon Rank Sum Test|Wilcoxon test stratified by Baseline OCS (0-\<=20 mg/day, \>20 mg/day prednisone or equivalent) and region.|Treatment comparison between placebo and mepolizumab 300 mg using rate ratio and 95% CI has been presented. Rate ratio \<1 indicates a lower flare rate with Mepolizumab compared with Placebo.|||0.63|0.19|0.002
74091886|NCT02836496|147737560|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank Sum Test|P-value was calculated using Wilcoxon Rank Sum Test||||||0.036
74091887|NCT03822832|147737561|OTHER||Mean Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|17.4||0.1492|TWO_SIDED|90.0|-54.9|3.7|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||3.7|-54.9|0.1492
74091888|NCT03822832|147737563|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.8||0.8613|TWO_SIDED|90.0|-5.7|7.0|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||7.0|-5.7|0.8613
74091889|NCT03822832|147737564|OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|14.0||0.8754|TWO_SIDED|90.0|-25.8|21.4|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||21.4|-25.8|0.8754
74091890|NCT03822832|147737565|OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|90.0|-0.254|0.176||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.176|-0.254|
73878689|NCT00467740|147297082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.048||0.0037||95.0|0.046|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.234|0.046|0.0037
74091891|NCT03822832|147737565|OTHER||Risk Difference (RD)|0.247|||||TWO_SIDED|90.0|0.053|0.396||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 16||0.396|0.053|
74091892|NCT03822832|147737566|OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|90.0|-0.204|0.117||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.117|-0.204|
74091893|NCT03822832|147737566|OTHER||Risk Difference (RD)|0.096|||||TWO_SIDED|90.0|-0.08|0.232||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Pl|Risk difference at week 16||0.232|-0.080|
74091894|NCT03822832|147737567|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|8.7||0.99|TWO_SIDED|90.0|-14.6|14.8|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||14.8|-14.6|0.9900
74091895|NCT03822832|147737568|OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|12.1||0.2266|TWO_SIDED|90.0|-35.2|5.5|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||5.5|-35.2|0.2266
74091896|NCT03822832|147737569|OTHER||Risk Difference (RD)|0.005|||||TWO_SIDED|90.0|-0.159|0.12||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.120|-0.159|
74091897|NCT03822832|147737569|OTHER||Risk Difference (RD)|0.091|||||TWO_SIDED|90.0|-0.05|0.207||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 16||0.207|-0.050|
74091898|NCT04492020|147737578|SUPERIORITY||Odds Ratio (OR)|2.09|||<|0.0001|TWO_SIDED|95.0|1.63|2.69|||generalized linear mixed model (GLMM)|||||2.69|1.63|<.0001
74091899|NCT04492020|147737579|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.63|2.78|||generalized linear mixed model (GLMM)|||||2.78|1.63|<.0001
74091900|NCT04492020|147737580|SUPERIORITY||Geometric Mean Odds Ratio|1.66|||<|0.0001|TWO_SIDED|95.0|1.4|1.96|||generalized estimating equation (GEE)|||||1.96|1.40|<.0001
73878690|NCT00467740|147297083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.046||0.2646||95.0|-0.039|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.142|-0.039|0.2646
73878691|NCT00467740|147297083|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.046||0.3527||95.0|-0.048|0.135|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.135|-0.048|0.3527
73878692|NCT00467740|147297083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.046||0.1369||95.0|-0.022|0.16|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.160|-0.022|0.1369
73878693|NCT00467740|147297083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.046||0.0051||95.0|0.039|0.221|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.221|0.039|0.0051
73878694|NCT00467740|147297084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.053||0.017||95.0|0.023|0.232|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.232|0.023|0.0170
73878695|NCT00467740|147297084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.053||0.0646||95.0|-0.006|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.204|-0.006|0.0646
73878696|NCT00467740|147297084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.053||0.602||95.0|-0.077|0.132|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.132|-0.077|0.6020
73878697|NCT00467740|147297084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.053||0.0147||95.0|0.026|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.233|0.026|0.0147
74091901|NCT04492020|147737581|SUPERIORITY||Odds Ratio (OR)|1.93|||<|0.0001|TWO_SIDED|95.0|1.39|2.66|||generalized linear mixed model (GLMM)|||||2.66|1.39|<.0001
74091902|NCT00063635|147737582|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel|||||||0.26
74091903|NCT00063635|147737582|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel|||||||0.83
73878698|NCT00467740|147297085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.053||0.4902||95.0|-0.068|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.142|-0.068|0.4902
73878699|NCT00467740|147297085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.054||0.2832||95.0|-0.048|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.164|-0.048|0.2832
73878700|NCT00467740|147297085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.054||0.6516||95.0|-0.081|0.13|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.130|-0.081|0.6516
73878701|NCT00467740|147297085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.053||0.006||95.0|0.042|0.252|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.252|0.042|0.0060
73878702|NCT00467740|147297086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.05||0.0005||95.0|0.079|0.277|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.277|0.079|0.0005
73878703|NCT00467740|147297086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.051||0.007||95.0|0.038|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.237|0.038|0.0070
73878704|NCT00467740|147297086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.05||0.0512||95.0|-0.001|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.198|-0.001|0.0512
73878705|NCT00467740|147297086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.133|0.331|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.331|0.133|<0.0001
73878706|NCT00467740|147297087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.061||0.1811||95.0|-0.039|0.203|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.203|-0.039|0.1811
73878707|NCT00467740|147297087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.062||0.2118||95.0|-0.044|0.199|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.199|-0.044|0.2118
74091904|NCT00063635|147737583|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||ANCOVA|||||||0.32
74091905|NCT00063635|147737583|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|||||||0.29
74091906|NCT00063635|147737584|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||||||0.02
74091907|NCT00063635|147737584|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||0.25
74091908|NCT00063635|147737585|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Chi-squared|||||||0.71
74091909|NCT00063635|147737585|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Chi-squared|||||||0.72
74091910|NCT00063635|147737586|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Chi-squared|||||||0.18
74091911|NCT00063635|147737586|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Chi-squared|||||||0.25
74091912|NCT00063635|147737587|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Chi-squared|||||||0.89
74091913|NCT00063635|147737587|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||||||0.73
74091914|NCT00063635|147737588|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
74091915|NCT00063635|147737588|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
74091916|NCT00063635|147737589|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||ANCOVA|||||||0.77
74091917|NCT00063635|147737589|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||0.25
74091918|NCT00063635|147737590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74091919|NCT00063635|147737590|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANCOVA|||||||0.44
74091920|NCT00063635|147737591|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANCOVA|||||||0.08
74091921|NCT00063635|147737591|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANCOVA|||||||0.63
74091922|NCT00063635|147737592|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANCOVA|||||||0.15
74091923|NCT00063635|147737592|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||||||0.96
74091924|NCT02792959|147737635|NON_INFERIORITY|alpha=5%|Mean Difference (Net)|0.273||||0.602|TWO_SIDED||||||Kruskal-Wallis|||||||0.602
74091925|NCT02792959|147737636|SUPERIORITY|alpha=5%|Mean Difference (Net)|3.361||||0.067|TWO_SIDED||||||Kruskal-Wallis|||||||0.067
74091926|NCT02792959|147737637|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.0||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
74091927|NCT02792959|147737638|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.091||||0.296|TWO_SIDED||||||Kruskal-Wallis|||||||0.296
74091928|NCT02792959|147737639|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.068||||0.794|TWO_SIDED||||||Kruskal-Wallis|||||||0.794
74091929|NCT02792959|147737640|SUPERIORITY|alpha=5%|Mean Difference (Net)|3.361||||0.067|TWO_SIDED||||||Kruskal-Wallis|||||||0.067
74091930|NCT02792959|147737641|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.0||||0.296|TWO_SIDED||||||Kruskal-Wallis|||||||0.296
74091931|NCT02792959|147737642|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.39||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
74091932|NCT02792959|147737643|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.068||||0.794|TWO_SIDED||||||Kruskal-Wallis|||||||0.794
74091933|NCT02792959|147737644|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.39||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
74091934|NCT02792959|147737645|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.273||||0.602|TWO_SIDED||||||Kruskal-Wallis|||||||0.602
74091935|NCT02792959|147737646|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.705||||0.192|TWO_SIDED||||||Kruskal-Wallis|||||||0.192
74091936|NCT03914950|147737656|OTHER|"The calculation of power and sample size is based on a formula that selects the sample size so that the lower limit of the 95% confidence interval by the expected specificity of the new method most probably exceeds the specificity value of the current method.~Receiver operating characteristics (ROC) analysis of the values of SUVmax of the early and delayed images with and without TOF of all pancreatic lesions was done in correlation with the histopathological findings."||||||0.78|||||||DeLong-test|The threshold for statistical significance was p=0.05.||It was calculated that 118 participants would have at least 90% power to demonstrate an improvement in specificity of 25% (to 70%) with the new method assuming a specificity of the current method of 45% at a prevalence of malignant lesions of 70% (corresponding to 30% benign lesions). Assumptions included a discontinuation rate of 25%.||||0.78
74091937|NCT03914950|147737656|OTHER|||||||0.95|||||||DeLong-test|The threshold for statistical significance was p=0.05.||||||0.95
74091938|NCT02566993|147737677|SUPERIORITY||Hazard Ratio (HR)|0.967||||0.9029|TWO_SIDED|95.0|0.815|1.148|||Log Rank|Stratified log-rank test||||1.148|0.815|0.9029
74091939|NCT02566993|147737678|SUPERIORITY|||||||0.2826|||||||Normal test|||||||0.2826
74091940|NCT02566993|147737679|SUPERIORITY|||||||0.6216|||||||Normal test|||||||0.6216
74091941|NCT02566993|147737680|SUPERIORITY|||||||0.9708|||||||Normal test|||||||0.9708
74091942|NCT02566993|147737681|SUPERIORITY||Hazard Ratio (HR)|0.831||||0.3257|TWO_SIDED|95.0|0.693|0.996|||Log Rank|Stratified log-rank test||||0.996|0.693|0.3257
74091943|NCT02566993|147737682|SUPERIORITY|||||||0.0851|||||||Normal test|||||||0.0851
74091944|NCT02566993|147737683|SUPERIORITY|||||||0.0129|||||||Normal test|||||||0.0129
74091945|NCT02566993|147737685|SUPERIORITY|||||||0.6616|||||||Binomial test|||||||0.6616
74091946|NCT02566993|147737686|SUPERIORITY||Hazard Ratio (HR)|0.581||||0.0012|TWO_SIDED|95.0|0.416|0.812|||Log Rank|||||0.812|0.416|0.0012
74091947|NCT02566993|147737687|SUPERIORITY||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.744|1.14||||||||1.140|0.744|
74091948|NCT02566993|147737688|SUPERIORITY||Hazard Ratio (HR)|0.688|||||TWO_SIDED|95.0|0.549|0.863||||||||0.863|0.549|
74091949|NCT02566993|147737690|SUPERIORITY||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.616|1.376||||||||1.376|0.616|
74091950|NCT02566993|147737691|SUPERIORITY||Hazard Ratio (HR)|0.504|||||TWO_SIDED|95.0|0.346|0.736||||||||0.736|0.346|
74091951|NCT02566993|147737692|SUPERIORITY||Hazard Ratio (HR)|1.122|||||TWO_SIDED|95.0|0.84|1.5||||||||1.500|0.840|
74091952|NCT02566993|147737693|SUPERIORITY||Hazard Ratio (HR)|1.306|||||TWO_SIDED|95.0|0.955|1.786||||||||1.786|0.955|
74091953|NCT02566993|147737695|SUPERIORITY||Hazard Ratio (HR)|0.915|||||TWO_SIDED|95.0|0.455|1.843||||||||1.843|0.455|
74091954|NCT02566993|147737696|SUPERIORITY||Hazard Ratio (HR)|1.092|||||TWO_SIDED|95.0|0.506|2.36||||||||2.360|0.506|
74091955|NCT02566993|147737697|SUPERIORITY||Hazard Ratio (HR)|0.923|||||TWO_SIDED|95.0|0.765|1.113||||||||1.113|0.765|
74091956|NCT02566993|147737698|SUPERIORITY||Hazard Ratio (HR)|0.788|||||TWO_SIDED|95.0|0.645|0.961||||||||0.961|0.645|
74091957|NCT02566993|147737700|SUPERIORITY||Hazard Ratio (HR)|0.903|||||TWO_SIDED|95.0|0.624|1.307||||||||1.307|0.624|
74091958|NCT02566993|147737701|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.392|0.799||||||||0.799|0.392|
74091959|NCT02566993|147737702|SUPERIORITY||Hazard Ratio (HR)|1.291|||||TWO_SIDED|95.0|0.838|1.99||||||||1.990|0.838|
74091960|NCT02566993|147737703|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.824|2.019||||||||2.019|0.824|
74091961|NCT02566993|147737705|SUPERIORITY||Hazard Ratio (HR)|1.032|||||TWO_SIDED|95.0|0.403|2.641||||||||2.641|0.403|
74091962|NCT02566993|147737706|SUPERIORITY||Hazard Ratio (HR)|1.013|||||TWO_SIDED|95.0|0.373|2.75||||||||2.750|0.373|
74091963|NCT03127644|147737719|SUPERIORITY||Treatment difference in slopes|-0.00496|STANDARD_ERROR_OF_MEAN|0.00038|<|0.0001|TWO_SIDED|95.0|-0.00571|-0.0042|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).||-0.00420|-0.00571|<0.0001
74091964|NCT03127644|147737719|SUPERIORITY||Treatment difference in slopes|-0.00261|STANDARD_ERROR_OF_MEAN|0.000385|<|0.001|TWO_SIDED|95.0|-0.00337|-0.00185|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).||-0.00185|-0.00337|<0.001
74091965|NCT03127644|147737720|SUPERIORITY||Odds Ratio (OR)|46.495|||<|0.0001|TWO_SIDED|95.0|10.142|213.152|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||213.152|10.142|<0.0001
74091966|NCT03127644|147737720|SUPERIORITY||Odds Ratio (OR)|71.835|||<|0.0001|TWO_SIDED|95.0|13.497|382.337|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||382.337|13.497|<0.0001
74091967|NCT03127644|147737721|SUPERIORITY||Treatment difference in slopes|-0.00231|STANDARD_ERROR_OF_MEAN|0.000645||0.0004|TWO_SIDED|95.0|-0.00359|-0.00104|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).||-0.00104|-0.00359|0.0004
74091968|NCT03127644|147737721|OTHER||Treatment difference in slopes|-0.00401|STANDARD_ERROR_OF_MEAN|0.000637|<|0.0001|TWO_SIDED|95.0|-0.00527|-0.00275|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).||-0.00275|-0.00527|<0.0001
74091969|NCT03127644|147737722|SUPERIORITY||Odds Ratio (OR)|1.347||||0.6167|TWO_SIDED|95.0|0.419|4.329|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||4.329|0.419|0.6167
74091970|NCT03127644|147737722|SUPERIORITY||Odds Ratio (OR)|15.334|||<|0.0001|TWO_SIDED|95.0|4.006|58.697|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||58.697|4.006|<0.0001
74091971|NCT03127644|147737726|SUPERIORITY|||||||0.0586||||||Nominal p value|Log Rank|||||||0.0586
74091972|NCT03127644|147737726|SUPERIORITY|||||||0.0006||||||Nominal p value|Log Rank|||||||0.0006
74091973|NCT03127644|147737727|SUPERIORITY|||||||0.025||||||Nominal p value|Log Rank|||||||0.0250
74091974|NCT03127644|147737727|SUPERIORITY|||||||0.0064||||||Nominal p value|Log Rank|||||||0.0064
74091975|NCT00311311|147737734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.0445|TWO_SIDED|95.0|0.001|0.07||P-value and 95% CI for least square (LS) mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|12 months post-transplant||0.070|0.001|0.0445
74091976|NCT00311311|147737734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.0288|TWO_SIDED|95.0|0.004|0.064||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant||0.064|0.004|0.0288
74091977|NCT00311311|147737734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0269|TWO_SIDED|95.0|0.004|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant||0.060|0.004|0.0269
74091978|NCT00311311|147737734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.097|TWO_SIDED|95.0|-0.005|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant||0.060|-0.005|0.0970
74091979|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.39|1.09||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 12 Months Post-transplant||1.09|0.39|<.0001
74091980|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.0022|TWO_SIDED|95.0|0.15|0.67||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 12 Months Post-transplant||0.67|0.15|0.0022
74091981|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.1612|TWO_SIDED|95.0|-0.03|0.19||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 12 Months Post-transplant||0.19|-0.03|0.1612
74091982|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.0005|TWO_SIDED|95.0|0.26|0.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 12 Months Post-transplant||0.86|0.26|0.0005
74091983|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.0006|TWO_SIDED|95.0|0.3|1.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 18 Months Post-transplant||1.02|0.30|0.0006
74091984|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.0126|TWO_SIDED|95.0|0.08|0.61||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 18 Months Post-transplant||0.61|0.08|0.0126
74091985|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.238|TWO_SIDED|95.0|-0.04|0.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 18 Months Post-transplant||0.17|-0.04|0.2380
74091986|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0003|TWO_SIDED|95.0|0.27|0.88||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 18 Months Post-transplant||0.88|0.27|0.0003
74091987|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0065|TWO_SIDED|95.0|0.17|1.0||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 24 Months Post-transplant||1.00|0.17|0.0065
74091988|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.0845|TWO_SIDED|95.0|-0.04|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 24 Months Post-transplant||0.60|-0.04|0.0845
74091989|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.3742|TWO_SIDED|95.0|-0.06|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 24 Months Post-transplant||0.16|-0.06|0.3742
74091990|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0006|TWO_SIDED|95.0|0.27|0.92||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 24 Months Post-transplant||0.92|0.27|0.0006
74091991|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.1488|TWO_SIDED|95.0|-0.16|1.03||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 36 Months Post-transplant||1.03|-0.16|0.1488
74091992|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.546|TWO_SIDED|95.0|-0.33|0.62||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 36 Months Post-transplant||0.62|-0.33|0.5460
74091993|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.7511|TWO_SIDED|95.0|-0.12|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 36 Months Post-transplant||0.16|-0.12|0.7511
74091994|NCT00311311|147737737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.0048|TWO_SIDED|95.0|0.2|1.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 36 Months Post-transplant||1.06|0.20|0.0048
74091995|NCT00311311|147737738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78||||0.1757|TWO_SIDED|95.0|-0.36|1.91||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||1.91|-0.36|0.1757
74091996|NCT00311311|147737738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.0509|TWO_SIDED|95.0|0.0|1.89||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.89|-0.00|0.0509
74091997|NCT00311311|147737738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.11||||0.0683|TWO_SIDED|95.0|-0.09|2.31||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||2.31|-0.09|0.0683
74091998|NCT00311311|147737739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.47||||0.2741|TWO_SIDED|95.0|-105.79|30.85||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||30.85|-105.79|0.2741
74091999|NCT00311311|147737739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.97||||0.4865|TWO_SIDED|95.0|-77.48|37.53||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||37.53|-77.48|0.4865
73878708|NCT00467740|147297087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.062||0.5504||95.0|-0.085|0.158|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.158|-0.085|0.5504
74092000|NCT00311311|147737739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48||||0.9339|TWO_SIDED|95.0|-62.54|57.59||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||57.59|-62.54|0.9339
74092001|NCT00311311|147737740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.4892|TWO_SIDED|95.0|-0.005|0.011||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||0.011|-0.005|0.4892
74092002|NCT00311311|147737740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.0514|TWO_SIDED|95.0|0.0|0.012||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant||0.012|-0.000|0.0514
74039886|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.0841|TWO_SIDED|95.0|-0.66|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.66|0.0841
74039887|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.0074|TWO_SIDED|95.0|-0.85|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.85|0.0074
74039888|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.316|TWO_SIDED|95.0|-0.49|0.16|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.49|0.3160
74039889|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.3763|TWO_SIDED|95.0|-0.47|0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.47|0.3763
74039890|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0505|TWO_SIDED|95.0|-0.65|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.00|-0.65|0.0505
74039891|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0118|TWO_SIDED|95.0|-0.88|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.88|0.0118
74039892|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.0012|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-1.03|0.0012
74039893|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2966|TWO_SIDED|95.0|-0.54|0.17|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.54|0.2966
74039894|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0956|TWO_SIDED|95.0|-0.66|0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.66|0.0956
74039895|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0117|TWO_SIDED|95.0|-0.81|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.81|0.0117
74039896|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2||0.3732|TWO_SIDED|95.0|-0.57|0.21|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.57|0.3732
74092003|NCT00311311|147737740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.009||||0.118|TWO_SIDED|95.0|-0.002|0.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||0.020|-0.002|0.1180
74092004|NCT00311311|147737741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56||||0.0016|TWO_SIDED|95.0|2.2|8.93||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||8.93|2.20|0.0016
74009281|NCT04667377|147569397|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|3.28||||0.0015|TWO_SIDED|95.0|1.57|6.84||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||6.84|1.57|0.0015
74009282|NCT04667377|147569397|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|8.83|||<|0.0001|TWO_SIDED|95.0|4.0|19.46||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||19.46|4.00|<.0001
74009283|NCT04667377|147569397|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|7.48|||<|0.0001|TWO_SIDED|95.0|3.41|16.41||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||16.41|3.41|<.0001
74009284|NCT04667377|147569397|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|10.77|||<|0.0001|TWO_SIDED|95.0|4.77|24.31||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||24.31|4.77|<.0001
74039897|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.2||0.1922|TWO_SIDED|95.0|-0.66|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.66|0.1922
74039898|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.21||0.2986|TWO_SIDED|95.0|-0.63|0.19|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.63|0.2986
74039899|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.21||0.2584|TWO_SIDED|95.0|-0.65|0.17|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.65|0.2584
74092005|NCT00311311|147737741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.91||||0.0091|TWO_SIDED|95.0|1.01|6.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||6.80|1.01|0.0091
74092006|NCT00311311|147737741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.25||||0.2468|TWO_SIDED|95.0|-1.6|6.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||6.10|-1.60|0.2468
74092007|NCT00311311|147737742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95||||0.5282|TWO_SIDED|95.0|-2.05|3.94||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||3.94|-2.05|0.5282
74009285|NCT04667377|147569398|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|3.22||||0.012|TWO_SIDED|95.0|1.29|8.02||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||8.02|1.29|0.0120
74009286|NCT04667377|147569398|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|10.62|||<|0.0001|TWO_SIDED|95.0|4.36|25.86||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||25.86|4.36|<.0001
74009287|NCT04667377|147569398|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|9.78|||<|0.0001|TWO_SIDED|95.0|4.02|23.79||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||23.79|4.02|<.0001
74009288|NCT04667377|147569398|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|14.5|||<|0.0001|TWO_SIDED|95.0|5.91|35.55||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||35.55|5.91|<.0001
74039900|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5195|TWO_SIDED|95.0|-0.57|0.29|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.29|-0.57|0.5195
74039901|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.21||0.3752|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.22|-0.60|0.3752
74039902|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5157|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5157
74039903|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.21||0.5065|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5065
74092008|NCT00311311|147737742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27||||0.5057|TWO_SIDED|95.0|-2.53|5.07||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||5.07|-2.53|0.5057
74092009|NCT00311311|147737742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59||||0.5701|TWO_SIDED|95.0|-4.0|7.18||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||7.18|-4.00|0.5701
74092010|NCT00311311|147737744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.028|TWO_SIDED|95.0|0.03|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||12 months post-transplant||0.48|0.03|0.0280
74092011|NCT00311311|147737744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.019|TWO_SIDED|95.0|0.04|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||24 months post-transplant||0.48|0.04|0.0190
74092012|NCT00311311|147737744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.1182|TWO_SIDED|95.0|-0.07|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||36 months post-transplant||0.60|-0.07|0.1182
74092013|NCT00311311|147737745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.7361|TWO_SIDED|95.0|-2.09|1.49||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||1.49|-2.09|0.7361
74092014|NCT00311311|147737745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.5549|TWO_SIDED|95.0|-2.32|1.26||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.26|-2.32|0.5549
74092015|NCT00311311|147737745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.6058|TWO_SIDED|95.0|-3.69|2.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||2.17|-3.69|0.6058
74092016|NCT00311311|147737746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.5902|TWO_SIDED|95.0|-1.63|2.84||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||2.84|-1.63|0.5902
74092017|NCT00311311|147737746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.7536|TWO_SIDED|95.0|-2.68|1.95||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.95|-2.68|0.7536
74092018|NCT00311311|147737746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33||||0.4066|TWO_SIDED|95.0|-4.53|1.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||1.86|-4.53|0.4066
74092019|NCT00311311|147737747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.47||||0.3678|TWO_SIDED|95.0|-11.46|30.4||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||30.40|-11.46|0.3678
74092020|NCT00311311|147737747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.72||||0.2179|TWO_SIDED|95.0|-6.53|27.97||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||27.97|-6.53|0.2179
74092021|NCT00311311|147737747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.96||||0.3663|TWO_SIDED|95.0|-14.39|38.32||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||38.32|-14.39|0.3663
74092022|NCT00311311|147737748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.041|TWO_SIDED|95.0|0.0|0.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||0.8|0.0|0.0410
74092023|NCT00311311|147737748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.0275|TWO_SIDED|95.0|0.0|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||0.6|0.0|0.0275
74092024|NCT00311311|147737748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.1841|TWO_SIDED|95.0|-0.1|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||0.6|-0.1|0.1841
74092025|NCT00311311|147737749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.3||||0.0797|TWO_SIDED|95.0|-108.9|6.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||12 months post-transplant||6.3|-108.9|0.0797
74092026|NCT00311311|147737749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.3||||0.2341|TWO_SIDED|95.0|-88.7|22.2||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant||22.2|-88.7|0.2341
74092027|NCT00311311|147737749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2||||0.6854|TWO_SIDED|95.0|-90.3|59.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||59.8|-90.3|0.6854
74092028|NCT00311311|147737750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.8||||0.0002|TWO_SIDED|95.0|-108.6|-36.9||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||-36.9|-108.6|0.0002
74092029|NCT00311311|147737750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.6||||0.0017|TWO_SIDED|95.0|-108.5|-26.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||-26.6|-108.5|0.0017
74092030|NCT00311311|147737750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.3||||0.0293|TWO_SIDED|95.0|-118.2|-6.5||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||-6.5|-118.2|0.0293
74092031|NCT00311311|147737752|SUPERIORITY_OR_OTHER|||||||0.2573|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Consent to Conversion||||0.2573
74092032|NCT00311311|147737752|SUPERIORITY_OR_OTHER|||||||0.6386|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Conversion to Month 12||||0.6386
74092033|NCT00311311|147737752|SUPERIORITY_OR_OTHER|||||||0.0709|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 12 to Month 24||||0.0709
74092034|NCT00311311|147737752|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 24 to Month 36||||1.0000
74092035|NCT00311311|147737753|SUPERIORITY_OR_OTHER|||||||0.4286|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Consent to Conversion||||0.4286
74092036|NCT00311311|147737753|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Conversion to Month 12||||1.0000
74092037|NCT00311311|147737753|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 12 to Month 24||||1.0000
74092038|NCT00311311|147737753|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 24 to Month 36||||1.0000
74039904|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.21||0.8373|TWO_SIDED|95.0|-0.47|0.38|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.38|-0.47|0.8373
74039905|NCT02528253|147632459|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5146|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5146
74092039|NCT00311311|147737754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.0||||0.2718|TWO_SIDED|95.0|-50.7|14.7||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant||14.7|-50.7|0.2718
74092040|NCT00311311|147737754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7||||0.2729|TWO_SIDED|95.0|-41.6|12.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant||12.1|-41.6|0.2729
74092041|NCT00311311|147737754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.2902|TWO_SIDED|95.0|-23.8|7.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant||7.3|-23.8|0.2902
74092042|NCT01610453|147737755|SUPERIORITY_OR_OTHER||||||<|0.01||||||A sample size calculation with alpha 0.05, power 0.8, and cut-off level of HPD at 40 mm. 146 women should be included. The calculation was based from a previous study, in which 93% with HPD ≤40 mm and 57% of with HPD \> 40 mm delivered vaginally.|Chi-squared|||Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance ≤40 mm was used as cut-off level. Vaginal delivery was the primary outcome measure.||||<0.01
74092043|NCT01610453|147737756|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.01
74092044|NCT03979820|147737760|OTHER||Ratio of geometric mean TSFs|544.36|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|340.57|870.09|||ANOVA||"The arm Phenelzine/Phenelzine + Tyramine represented the numerator. The arm Placebo/Placebo + Tyramine represented the denominator."|"The statistical model used for the analysis of the primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale for each treatment relative to placebo.~TSF was log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the fixed effects 'treatment'."||870.09|340.57|
74039906|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0059|TWO_SIDED|95.0|-0.76|-0.13|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.76|0.0059
74039907|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.93|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-0.93|0.0002
74039908|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.0756|TWO_SIDED|95.0|-0.56|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.56|0.0756
74039909|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2197|TWO_SIDED|95.0|-0.47|0.11|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.47|0.2197
74039910|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.15||0.0208|TWO_SIDED|95.0|-0.63|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.63|0.0208
74039911|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.17||0.0013|TWO_SIDED|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.91|0.0013
74039912|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.08|-0.39|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.39|-1.08|<.0001
74039913|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.1873|TWO_SIDED|95.0|-0.53|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.53|0.1873
74039914|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0305|TWO_SIDED|95.0|-0.66|-0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.66|0.0305
74039915|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0013|TWO_SIDED|95.0|-0.84|-0.2|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.20|-0.84|0.0013
74039916|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0158|TWO_SIDED|95.0|-0.78|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.78|0.0158
74039917|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.18||0.0015|TWO_SIDED|95.0|-0.91|-0.21|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.21|-0.91|0.0015
73878709|NCT00467740|147297087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.062||0.0022||95.0|0.069|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.312|0.069|0.0022
74039918|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.4173|TWO_SIDED|95.0|-0.45|0.19|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.45|0.4173
74092045|NCT03979820|147737760|OTHER||Ratio of geometric mean TSFs|123.22|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|77.09|196.95|||ANOVA||"The arm 10 mg BI 1467335/10 mg BI 1467335 + Tyramine represented the numerator.~The arm Placebo/Placebo + Tyramine represented the denominator."|"The statistical model used for the analysis of the primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale for each treatment relative to placebo.~TSF was log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the fixed effects 'treatment'."||196.95|77.09|
74092046|NCT00988065|147737761|SUPERIORITY_OR_OTHER||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||3.7|-1.8|
74092047|NCT00988065|147737761|SUPERIORITY_OR_OTHER||Difference in event rates|4.7||||||95.0|2.1|9.3|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||9.3|2.1|
74092048|NCT00988065|147737762|SUPERIORITY_OR_OTHER||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||3.7|-1.8|
74039919|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0659|TWO_SIDED|95.0|-0.62|0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.62|0.0659
74092049|NCT00988065|147737762|SUPERIORITY_OR_OTHER||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||2.5|-2.5|
74092050|NCT00988065|147737763|SUPERIORITY_OR_OTHER||Difference in event rates|2.0||||||95.0|-0.5|5.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.||5.7|-0.5|
74092051|NCT00988065|147737763|SUPERIORITY_OR_OTHER||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.||2.5|-2.5|
74092052|NCT01229735|147737769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||=|0.7007|TWO_SIDED|95.0|0.7|1.7||P-value is from likelihood ratio test of treatment group regression coefficient against 0.|Regression, Logistic|||The Odds Ratio (OR) for LEV vs TPM is based on logistic regression modeling of subject retention by treatment and center pooling category. A profile likelihood confidence interval for the OR is presented.||1.7|0.7|=0.7007
74039920|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.16||0.0078|TWO_SIDED|95.0|-0.74|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.74|0.0078
74039921|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.0737|TWO_SIDED|95.0|-0.72|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.72|0.0737
74039922|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.0021|TWO_SIDED|95.0|-0.97|-0.22|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.97|0.0021
74039923|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.18||0.4535|TWO_SIDED|95.0|-0.48|0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.48|0.4535
74039924|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.18||0.2271|TWO_SIDED|95.0|-0.56|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.56|0.2271
74092053|NCT00985712|147737785|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6692|TWO_SIDED|95.0|-0.17|0.26|||Mixed Models Analysis|The model details are given in the section of Measure Description.||Superiority criterion is met if the upper limit of Confidence Interval (CI) is below zero.||0.26|-0.17|0.6692
74092054|NCT00985712|147737786|SUPERIORITY_OR_OTHER|||||||0.3551||95.0||||P-value is for HbA1c ≤7.0%.|Chi-squared|||||||0.3551
74092055|NCT00985712|147737786|SUPERIORITY_OR_OTHER|||||||0.2026||95.0||||P-value is for HbA1c ≤7.5%.|Chi-squared|||||||0.2026
74092056|NCT00985712|147737787|SUPERIORITY_OR_OTHER|||||||0.907||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) was adjusted for baseline values.||||||0.9070
74092057|NCT00985712|147737788|SUPERIORITY_OR_OTHER|||||||0.9817||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9817
74092058|NCT00985712|147737789|SUPERIORITY_OR_OTHER|||||||0.1187||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1187
74092059|NCT01000493|147737790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.62||||0.3624|TWO_SIDED|95.0|-17.9|6.65||The mixed effects model repeated measures (MMRM) analysis included treatment, week, Baseline total CAPS score and the treatment by week and Baseline. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between Placebo and Orvepitant 60 mg at Week 12.|||6.65|-17.9|0.3624
74092060|NCT01000493|147737791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.3156|TWO_SIDED|95.0|0.54|6.76|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||6.76|0.54|0.3156
74092061|NCT01000493|147737791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.3024|TWO_SIDED|95.0|0.27|1.5|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||1.50|0.27|0.3024
74092062|NCT01000493|147737791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.1208|TWO_SIDED|95.0|0.79|7.28|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 8. Odds ratios represent the odds of improvement, relative to placebo.|||7.28|0.79|0.1208
74039925|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0086|TWO_SIDED|95.0|-0.81|-0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.81|0.0086
74039926|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.2243|TWO_SIDED|95.0|-0.63|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.63|0.2243
74039927|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.0331|TWO_SIDED|95.0|-0.81|-0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.81|0.0331
74039928|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1838|TWO_SIDED|95.0|-0.66|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.66|0.1838
74039929|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.0795|TWO_SIDED|95.0|-0.75|0.04|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.75|0.0795
74039930|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.21||0.2847|TWO_SIDED|95.0|-0.63|0.18|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.63|0.2847
74039931|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.2||0.0745|TWO_SIDED|95.0|-0.76|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.76|0.0745
74039932|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.311|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.59|0.3110
74092063|NCT01000493|147737791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27||||0.1331|TWO_SIDED|95.0|0.7|15.4|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||15.4|0.70|0.1331
74092064|NCT01000493|147737793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.7015|TWO_SIDED|95.0|-5.35|3.61||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||3.61|-5.35|0.7015
74092065|NCT01000493|147737793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.81||||0.4292|TWO_SIDED|95.0|-4.22|9.84||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||9.84|-4.22|0.4292
74092066|NCT01000493|147737793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.64||||0.3702|TWO_SIDED|95.0|-14.9|5.62||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||5.62|-14.9|0.3702
74092067|NCT01000493|147737794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.5719|TWO_SIDED|95.0|0.04|5.82|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||5.82|0.04|0.5719
74092068|NCT01000493|147737794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.908||95.0|0.07|20.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||20.1|0.07|0.9080
74092069|NCT01000493|147737794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.9486|TWO_SIDED|95.0|0.07|12.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||12.5|0.07|0.9486
74092070|NCT01000493|147737796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.5426|TWO_SIDED|95.0|-1.51|2.85||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||2.85|-1.51|0.5426
74092071|NCT01000493|147737796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.7552|TWO_SIDED|95.0|-2.73|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||3.75|-2.73|0.7552
74092072|NCT01000493|147737796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22||||0.3827|TWO_SIDED|95.0|-7.27|2.83||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||2.83|-7.27|0.3827
74092073|NCT01000493|147737796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.98||||0.4915|TWO_SIDED|95.0|-7.71|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.75|-7.71|0.4915
74092074|NCT01000493|147737797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.919|TWO_SIDED|95.0|-1.93|1.74||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||1.74|-1.93|0.9190
74092075|NCT01000493|147737797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.3326|TWO_SIDED|95.0|-1.37|4.0||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||4.00|-1.37|0.3326
74092076|NCT01000493|147737797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.9712|TWO_SIDED|95.0|-3.91|3.77||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||3.77|-3.91|0.9712
74092077|NCT01000493|147737797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92||||0.6711|TWO_SIDED|95.0|-5.22|3.39||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.39|-5.22|0.6711
74092078|NCT01000493|147737798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.5532|TWO_SIDED|95.0|0.36|6.92||The analysis method was logistic regression adjusted for Baseline total Clinical Global Impression-Severity of Illness scales (CGI-S) score.|Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||6.92|0.36|0.5532
74092079|NCT01000493|147737798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.4508|TWO_SIDED|95.0|0.54|3.93|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||3.93|0.54|0.4508
74092080|NCT01000493|147737798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9234|TWO_SIDED|95.0|0.42|2.62|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||2.62|0.42|0.9234
74092081|NCT01000493|147737798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.0662|TWO_SIDED|95.0|0.94|6.53|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 1|||6.53|0.94|0.0662
74092082|NCT01000493|147737798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.2767|TWO_SIDED|95.0|0.61|5.48|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||5.48|0.61|0.2767
74092083|NCT01000493|147737798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.17||||0.0588|TWO_SIDED|95.0|0.96|10.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||10.5|0.96|0.0588
74092084|NCT01000493|147737798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33||||0.1032|TWO_SIDED|95.0|0.78|14.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||14.1|0.78|0.1032
74092085|NCT01000493|147737799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.1743|TWO_SIDED|95.0|-0.29|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||0.05|-0.29|0.1743
74039933|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1375|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.70|0.1375
74039934|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.21||0.4036|TWO_SIDED|95.0|-0.58|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.58|0.4036
74039935|NCT02528253|147632461|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.0641|TWO_SIDED|95.0|-0.79|0.02|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.79|0.0641
74039936|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.18||0.0037|TWO_SIDED|95.0|-0.85|-0.17|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.17|-0.85|0.0037
74039937|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.0013|TWO_SIDED|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.91|0.0013
74039938|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1712|TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.53|0.1712
74039939|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.16||0.0686|TWO_SIDED|95.0|-0.6|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.60|0.0686
74039940|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0289|TWO_SIDED|95.0|-0.66|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.66|0.0289
74039941|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18||0.0003|TWO_SIDED|95.0|-1.02|-0.3|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.30|-1.02|0.0003
74039942|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.22|-0.49|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.49|-1.22|<.0001
74039943|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2056|TWO_SIDED|95.0|-0.55|0.12|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.55|0.2056
74039944|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.17||0.0084|TWO_SIDED|95.0|-0.78|-0.11|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.78|0.0084
74039945|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.17||0.0002|TWO_SIDED|95.0|-0.98|-0.31|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.31|-0.98|0.0002
74039946|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.0063|TWO_SIDED|95.0|-0.9|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.90|0.0063
73878710|NCT00467740|147297088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.102|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.255|0.102|<0.0001
73878711|NCT00467740|147297088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.106|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.260|0.106|<0.0001
73878712|NCT00467740|147297088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.096|0.25|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.250|0.096|<0.0001
73878713|NCT00467740|147297088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.214|0.367|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.367|0.214|<0.0001
73878714|NCT00467740|147297089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001||95.0|0.101|0.279|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.279|0.101|<0.0001
73878715|NCT00467740|147297089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001||95.0|0.107|0.286|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.286|0.107|<0.0001
73878716|NCT00467740|147297089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.045||0.0007||95.0|0.067|0.246|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.246|0.067|0.0007
73878717|NCT00467740|147297089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001||95.0|0.174|0.352|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.352|0.174|<0.0001
73878718|NCT00467740|147297090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.115|0.313|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.313|0.115|<0.0001
73878719|NCT00467740|147297090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.05||0.0021||95.0|0.057|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.255|0.057|0.0021
73878720|NCT00467740|147297090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.05||0.0795||95.0|-0.01|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.187|-0.010|0.0795
73878721|NCT00467740|147297090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.129|0.326|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.326|0.129|<0.0001
73878722|NCT00467740|147297091|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.049||0.0003||95.0|0.082|0.276|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.276|0.082|0.0003
73878723|NCT00467740|147297091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.049||0.0077||95.0|0.035|0.229|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.229|0.035|0.0077
73878724|NCT00467740|147297091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.049||0.0427||95.0|0.003|0.197|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.003|0.0427
73878725|NCT00467740|147297091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.143|0.336|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.336|0.143|<0.0001
73878726|NCT00467740|147297092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.048||0.0005||95.0|0.074|0.263|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.263|0.074|0.0005
73878727|NCT00467740|147297092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.048||0.0003||95.0|0.08|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.269|0.080|0.0003
73878728|NCT00467740|147297092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.048||0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.268|0.078|0.0004
73878729|NCT00467740|147297092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001||95.0|0.202|0.39|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.390|0.202|<0.0001
73878730|NCT00467740|147297093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.048||0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.268|0.078|0.0004
73878731|NCT00467740|147297093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.048||0.0002||95.0|0.09|0.281|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.281|0.090|0.0002
73878732|NCT00467740|147297093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.048||0.0047||95.0|0.043|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.233|0.043|0.0047
74039947|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.09|-0.34|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.34|-1.09|0.0002
73878733|NCT00467740|147297093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001||95.0|0.142|0.332|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.332|0.142|<0.0001
73878734|NCT00467740|147297094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.055||0.0002||95.0|0.096|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.312|0.096|0.0002
73878735|NCT00467740|147297094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.055||0.0057||95.0|0.045|0.261|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.261|0.045|0.0057
73878736|NCT00467740|147297094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.055||0.1513||95.0|-0.029|0.186|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.186|-0.029|0.1513
73878737|NCT00467740|147297094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001||95.0|0.114|0.328|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.328|0.114|<0.0001
73878738|NCT00467740|147297095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.054||0.0022||95.0|0.06|0.271|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.271|0.060|0.0022
73878739|NCT00467740|147297095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.054||0.0307||95.0|0.011|0.223|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.223|0.011|0.0307
73878740|NCT00467740|147297095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.054||0.132||95.0|-0.025|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.187|-0.025|0.1320
73878741|NCT00467740|147297095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001||95.0|0.127|0.337|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.337|0.127|<0.0001
73878742|NCT00467740|147297096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.056||0.1585||95.0|-0.031|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.188|-0.031|0.1585
74039948|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1155|TWO_SIDED|95.0|-0.63|0.07|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.63|0.1155
74039949|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.18||0.1652|TWO_SIDED|95.0|-0.59|0.1|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.59|0.1652
74092086|NCT01000493|147737799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.1181|TWO_SIDED|95.0|-0.46|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||0.05|-0.46|0.1181
73878743|NCT00467740|147297096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.056||0.0848||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.207|-0.013|0.0848
73878744|NCT00467740|147297096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.056||0.0838||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.207|-0.013|0.0838
73878745|NCT00467740|147297096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.056||0.0014||95.0|0.07|0.289|||Mixed Models Analysis||Olo 20 mcg qd minus Placebo|||0.289|0.070|0.0014
73878746|NCT00467740|147297097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.059||0.0959||95.0|-0.018|0.216|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.216|-0.018|0.0959
73878747|NCT00467740|147297097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.06||0.047||95.0|0.002|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.237|0.002|0.0470
73878748|NCT00467740|147297097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.06||0.196||95.0|-0.04|0.195|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.195|-0.040|0.1960
73878749|NCT00467740|147297097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.059||0.002||95.0|0.068|0.302|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.302|0.068|0.0020
73878750|NCT00467740|147297098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.064||0.027||95.0|0.016|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.269|0.016|0.0270
74039950|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.0129|TWO_SIDED|95.0|-0.78|-0.09|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.78|0.0129
74039951|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.21||0.0236|TWO_SIDED|95.0|-0.87|-0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.87|0.0236
74092087|NCT01000493|147737799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.9698|TWO_SIDED|95.0|-0.35|0.34||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||0.34|-0.35|0.9698
74092088|NCT01000493|147737799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.1341|TWO_SIDED|95.0|-0.69|0.09||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.|||0.09|-0.69|0.1341
74092089|NCT01000493|147737799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.0064|TWO_SIDED|95.0|-1.04|-0.18||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||-0.18|-1.04|0.0064
74092090|NCT01000493|147737799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.1095|TWO_SIDED|95.0|-0.98|0.1||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||0.10|-0.98|0.1095
74092091|NCT01000493|147737799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2814|TWO_SIDED|95.0|-0.9|0.27||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||0.27|-0.90|0.2814
74092092|NCT01000493|147737806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.92||||0.0083|TWO_SIDED|95.0|-3.33|-0.5||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1|||-0.50|-3.33|0.0083
74092093|NCT01000493|147737806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.94||||0.0311|TWO_SIDED|95.0|-3.71|-0.18||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||-0.18|-3.71|0.0311
74092094|NCT01000493|147737806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.1155|TWO_SIDED|95.0|-4.26|0.47||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||0.47|-4.26|0.1155
74092095|NCT01000493|147737806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.89||||0.021|TWO_SIDED|95.0|-5.33|-0.45||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.|||-0.45|-5.33|0.0210
74092096|NCT01000493|147737806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.86||||0.0582|TWO_SIDED|95.0|-5.83|0.1||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||0.10|-5.83|0.0582
74092097|NCT01000493|147737806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.88||||0.0927|TWO_SIDED|95.0|-6.25|0.49||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||0.49|-6.25|0.0927
74092098|NCT01000493|147737806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.8954|TWO_SIDED|95.0|-4.36|3.83||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.83|-4.36|0.8954
74092099|NCT03736213|147737814|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.13|TWO_SIDED||||||paired t-test, two-tailed|df = 6|Ultrasound biofeedback treatment condition - visual-acoustic biofeedback treatment condition. Because more accurate productions have lower normalized acoustic values, a negative difference indicates an advantage for US biofeedback.|||||.13
74092100|NCT00321737|147737815|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
74092101|NCT00321737|147737815|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
74092102|NCT00321737|147737815|SUPERIORITY_OR_OTHER||||||>|0.99999||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||>0.99999
74092103|NCT00321737|147737816|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
74092104|NCT00321737|147737816|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
74092105|NCT00321737|147737816|SUPERIORITY_OR_OTHER|||||||0.0673||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.06730
74092106|NCT00321737|147737818|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
74092107|NCT00321737|147737818|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
74092108|NCT00321737|147737818|SUPERIORITY_OR_OTHER|||||||0.13932||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.13932
74092109|NCT00321737|147737819|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
74039952|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0136|TWO_SIDED|95.0|-0.93|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.93|0.0136
74039953|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.6624|TWO_SIDED|95.0|-0.47|0.3|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.30|-0.47|0.6624
74039954|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.19||0.0468|TWO_SIDED|95.0|-0.75|-0.01|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.75|0.0468
74039955|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.025|TWO_SIDED|95.0|-0.81|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.81|0.0250
74039956|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1539|TWO_SIDED|95.0|-0.72|0.11|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.72|0.1539
74039957|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0169|TWO_SIDED|95.0|-0.91|-0.09|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.91|0.0169
74039958|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.21||0.1049|TWO_SIDED|95.0|-0.77|0.07|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.77|0.1049
74039959|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0599|TWO_SIDED|95.0|-0.82|0.02|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.82|0.0599
74039960|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.3041|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.3041
74039961|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0737|TWO_SIDED|95.0|-0.83|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.83|0.0737
74039962|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.23||0.2293|TWO_SIDED|95.0|-0.71|0.17|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.71|0.2293
74039963|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.22||0.0806|TWO_SIDED|95.0|-0.82|0.05|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.82|0.0806
74092110|NCT00321737|147737819|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
74092111|NCT00321737|147737819|SUPERIORITY_OR_OTHER|||||||0.11257||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.11257
74092112|NCT01769339|147737823|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74092113|NCT00290251|147737825|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|performed on log-transformed delta change in total fibroid volume from baseline to end of treatment||||||0.43
73878751|NCT00467740|147297098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.065||0.1031||95.0|-0.021|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.233|-0.021|0.1031
74039964|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.368|TWO_SIDED|95.0|-0.62|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.62|0.3680
74039965|NCT02528253|147632463|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.0893|TWO_SIDED|95.0|-0.79|0.06|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.79|0.0893
74039966|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.88|-0.24|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.88|0.0007
74039967|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.03|-0.38|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.38|-1.03|<.0001
74039968|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1291|TWO_SIDED|95.0|-0.53|0.07|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.53|0.1291
74039969|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.029|TWO_SIDED|95.0|-0.63|-0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.63|0.0290
74039970|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0015|TWO_SIDED|95.0|-0.77|-0.18|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.77|0.0015
74092114|NCT00290251|147737825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|95.0|||||ANOVA|Performed on log-transformed delta change||Ulipristal acetate groups one and two were first compared and found to be similar (see statistical analysis 1), so they were combined into a single treatment group for comparison to placebo group||||0.003
74039971|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.0041|TWO_SIDED|95.0|-0.87|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.17|-0.87|0.0041
74039972|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.25|-0.54|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.54|-1.25|<.0001
74039973|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.1799|TWO_SIDED|95.0|-0.55|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.55|0.1799
73878752|NCT00467740|147297098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.064||0.4378||95.0|-0.077|0.177|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.177|-0.077|0.4378
74039974|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0696|TWO_SIDED|95.0|-0.62|0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.62|0.0696
74039975|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.35|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.35|-0.99|<.0001
74092115|NCT00290251|147737826|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||The Delta of scores from treatment end to baseline was used to compare by ANOVA.|ANOVA|Adjustment for age||No sample size calculation was made.||||< 0.05
74092116|NCT02307266|147737873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3165|||||||Cochran-Mantel-Haenszel|||||||0.3165
74092117|NCT02307266|147737873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206|||||||Cochran-Mantel-Haenszel|||||||0.0206
73878753|NCT00467740|147297098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.064||0.0064||95.0|0.05|0.303|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.303|0.050|0.0064
74092118|NCT02440022|147737889|SUPERIORITY|||||||0.0562|||||||Kaplan-Meier|||||||0.0562
73878754|NCT00467740|147297099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.069||0.2781||95.0|-0.061|0.21|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.210|-0.061|0.2781
73878755|NCT00467740|147297099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.069||0.3284||95.0|-0.068|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.204|-0.068|0.3284
73878756|NCT00467740|147297099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.069||0.602||95.0|-0.1|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.171|-0.100|0.6020
73878757|NCT00467740|147297099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.069||0.0006||95.0|0.104|0.375|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.375|0.104|0.0006
73878758|NCT00467740|147297100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.067||0.4331|TWO_SIDED|95.0|-0.079|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.184|-0.079|0.4331
74039976|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.18||0.0387|TWO_SIDED|95.0|-0.74|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.74|0.0387
74092119|NCT02440022|147737890|NON_INFERIORITY|Where δ = 10% is the non-inferiority margin, which is the range of difference that is considered not clinically important. A non-inferiority Farrington and Manning Test was used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025. In addition to the p-value of the test, the confidence intervals of the rate in each group and the difference between the two groups is calculated.||||||0.002|||||||Binary Analysis|||"H0: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is inferior to that p2 of the PTA treatment group. (i.e. p1 ≤ p2 - δ)~H1: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is non-inferior to that p2 of the PTA treatment group. (i.e. p1 \> p2 - δ)"||||0.002
74092120|NCT02440022|147737896|OTHER|||||||0.716||||||P-value was type 3 test of the interaction of treatment group and pre-dilation balloon type.|Regression, Cox|||||||0.7160
74092121|NCT02504671|147737899|OTHER||Odds Ratio (OR)|2.12||||0.547|TWO_SIDED|95.0|0.18|24.52|||Regression, Logistic||95% Confidence Intervals (CI) were constructed using asymptotic Wald confidence limits without correction.|||24.52|0.18|0.547
74092122|NCT02504671|147737899|OTHER||Odds Ratio (OR)|7.11||||0.077|TWO_SIDED|95.0|0.81|62.44|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||62.44|0.81|0.077
73878759|NCT00467740|147297100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.068||0.515|TWO_SIDED|95.0|-0.089|0.178|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.178|-0.089|0.5150
73878760|NCT00467740|147297100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.068||0.5714|TWO_SIDED|95.0|-0.095|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.171|-0.095|0.5714
73878761|NCT00467740|147297100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.068||0.0177|TWO_SIDED|95.0|0.028|0.296|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.296|0.028|0.0177
73878762|NCT00467740|147297101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.97|STANDARD_ERROR_OF_MEAN|7.665||0.003|TWO_SIDED|95.0|7.883|38.057|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||38.057|7.883|0.0030
73878763|NCT00467740|147297101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.6|STANDARD_ERROR_OF_MEAN|7.7||0.0016|TWO_SIDED|95.0|9.446|39.754|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||39.754|9.446|0.0016
73878764|NCT00467740|147297101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.806|STANDARD_ERROR_OF_MEAN|7.727|<|0.0001|TWO_SIDED|95.0|21.598|52.015|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||52.015|21.598|<.0001
73878765|NCT00467740|147297101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.505|STANDARD_ERROR_OF_MEAN|7.675|<|0.0001|TWO_SIDED|95.0|27.399|57.611|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||57.611|27.399|<.0001
73878766|NCT00467740|147297102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.118|STANDARD_ERROR_OF_MEAN|1.055||0.2898|TWO_SIDED|95.0|-3.194|0.957|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.957|-3.194|0.2898
74092123|NCT02504671|147737899|OTHER||Odds Ratio (OR)|8.39||||0.053|TWO_SIDED|95.0|0.98|72.14|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||72.14|0.98|0.053
74009289|NCT04667377|147569399|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|2.13||||0.2654|TWO_SIDED|95.0|0.56|8.02||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||8.02|0.56|0.2654
74092124|NCT02504671|147737899|OTHER||Odds Ratio (OR)|5.69||||0.122|TWO_SIDED|95.0|0.63|51.4|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||51.40|0.63|0.122
74092125|NCT02504671|147737899|OTHER||Odds Ratio (OR)|5.4||||0.134|TWO_SIDED|95.0|0.6|48.83|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.83|0.60|0.134
74092126|NCT02504671|147737900|OTHER||Mean Difference (Net)|0.46||||0.905|TWO_SIDED|95.0|-7.13|8.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|Mixed Model Repeated Measures (MMRM)||CRP, Week 12|||8.05|-7.13|0.905
74092127|NCT02504671|147737900|OTHER||Mean Difference (Net)|-3.36||||0.387|TWO_SIDED|95.0|-11.0|4.28||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||4.28|-11.00|0.387
74092128|NCT02504671|147737900|OTHER||Mean Difference (Net)|-2.58||||0.495|TWO_SIDED|95.0|-10.04|4.87||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||4.87|-10.04|0.495
74039977|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.18||0.0005|TWO_SIDED|95.0|-1.0|-0.28|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-1.00|0.0005
74039978|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.2768|TWO_SIDED|95.0|-0.51|0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.51|0.2768
74039979|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2408|TWO_SIDED|95.0|-0.53|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.53|0.2408
74039980|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.17||0.0064|TWO_SIDED|95.0|-0.78|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.78|0.0064
74039981|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.2||0.0115|TWO_SIDED|95.0|-0.9|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.90|0.0115
74039982|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.2||0.0006|TWO_SIDED|95.0|-1.08|-0.29|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-1.08|0.0006
74039983|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.2028|TWO_SIDED|95.0|-0.59|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.59|0.2028
74039984|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1351|TWO_SIDED|95.0|-0.64|0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.64|0.1351
74092129|NCT02504671|147737900|OTHER||Mean Difference (Net)|-7.68||||0.14|TWO_SIDED|95.0|-17.92|2.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||2.55|-17.92|0.140
74092130|NCT02504671|147737900|OTHER||Mean Difference (Net)|-13.68||||0.009|TWO_SIDED|95.0|-23.85|-3.52||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-3.52|-23.85|0.009
74092131|NCT02504671|147737900|OTHER||Mean Difference (Net)|-17.4|||<|0.001|TWO_SIDED|95.0|-27.44|-7.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-7.35|-27.44|<0.001
74092132|NCT02504671|147737900|OTHER||Mean Difference (Net)|-2.42||||0.118|TWO_SIDED|95.0|-5.45|0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.62|-5.45|0.118
74092133|NCT02504671|147737900|OTHER||Mean Difference (Net)|-3.17||||0.041|TWO_SIDED|95.0|-6.2|-0.14||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||-0.14|-6.20|0.041
73878767|NCT00467740|147297102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.351|STANDARD_ERROR_OF_MEAN|1.057||0.027|TWO_SIDED|95.0|-4.432|-0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||-0.269|-4.432|0.0270
73878768|NCT00467740|147297102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.045|STANDARD_ERROR_OF_MEAN|1.063||0.0045|TWO_SIDED|95.0|-5.138|-0.952|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||-0.952|-5.138|0.0045
73878769|NCT00467740|147297102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.937|STANDARD_ERROR_OF_MEAN|1.053||0.0056|TWO_SIDED|95.0|-5.01|-0.865|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||-0.865|-5.010|0.0056
73878770|NCT00467740|147297103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.287|STANDARD_ERROR_OF_MEAN|0.257||0.2645|TWO_SIDED|95.0|-0.793|0.218|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.218|-0.793|0.2645
73878771|NCT00467740|147297103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.258||0.0423|TWO_SIDED|95.0|-1.034|-0.018|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||-0.018|-1.034|0.0423
73878772|NCT00467740|147297103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.332|STANDARD_ERROR_OF_MEAN|0.259||0.2008|TWO_SIDED|95.0|-0.842|0.178|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.178|-0.842|0.2008
74092134|NCT02504671|147737900|OTHER||Mean Difference (Net)|-4.56||||0.003|TWO_SIDED|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.05|-6.00|0.003
74009290|NCT04667377|147569399|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|9.47||||0.0002|TWO_SIDED|95.0|2.89|30.95||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||30.95|2.89|0.0002
74092135|NCT02504671|147737900|OTHER||Mean Difference (Net)|-2.3||||0.172|TWO_SIDED|95.0|-5.61|1.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TC28, Week 12|||1.01|-5.61|0.172
73878773|NCT00467740|147297103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.593|STANDARD_ERROR_OF_MEAN|0.257||0.0218|TWO_SIDED|95.0|-1.098|-0.087|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||-0.087|-1.098|0.0218
73878774|NCT00467740|147297112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.142|STANDARD_ERROR_OF_MEAN|0.114||0.2156||95.0|-0.368|0.083|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.083|-0.368|0.2156
73878775|NCT00467740|147297112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.114||0.0869||95.0|-0.422|0.029|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.029|-0.422|0.0869
73878776|NCT00467740|147297112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.328|STANDARD_ERROR_OF_MEAN|0.114||0.0044||95.0|-0.552|-0.103|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.103|-0.552|0.0044
73878777|NCT00467740|147297112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.113||0.0158||95.0|-0.499|-0.052|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||-0.052|-0.499|0.0158
73878778|NCT00844376|147297154|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|95.77||||||90.0|85.82|106.88|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUC48 was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUC48; restricted (residual) maximum likelihood (REML) method of estimation.||106.88|85.82|
73878779|NCT00844376|147297155|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|95.04||||||90.0|84.99|106.27|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUCinf||106.27|84.99|
73878780|NCT00844376|147297156|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|94.86||||||90.0|83.86|107.29|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUClast||107.29|83.86|
73878781|NCT00844376|147297157|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|117.9||||||90.0|98.22|141.53|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for Cmax||141.53|98.22|
73878782|NCT00660192|147297161|SUPERIORITY_OR_OTHER|||||||0.0347|TWO_SIDED||||||t-test, 2 sided|||||||0.0347
73878783|NCT00660192|147297162|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.0300
73878784|NCT01601535|147297176|OTHER|||||||0.14||||||MYCN Amplified vs. MYCN not Amplified|Fisher Exact|||||||0.14
73878785|NCT01601535|147297176|OTHER|||||||0.21|||||||Fisher Exact|MYCN Amplified or Myc Positive vs. MYCN Non-amplified and Myc Negative||||||0.21
73878786|NCT01601535|147297176|OTHER|||||||1|||||||Fisher Exact|Aurora A protein Positive vs. Aurora A protein Negative||||||1.0
74009291|NCT04667377|147569399|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|11.79|||<|0.0001|TWO_SIDED|95.0|3.62|38.36||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||38.36|3.62|<.0001
73878787|NCT01601535|147297177|OTHER|||||||0.094||||||UGT1A1 6\\6 vs. UGT1A1 6\\7 vs. UGT1A1 7\\7|Fisher Exact|||||||0.094
74092136|NCT02504671|147737900|OTHER||Mean Difference (Net)|-3.92||||0.02|TWO_SIDED|95.0|-7.22|-0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-0.62|-7.22|0.020
74092137|NCT02504671|147737900|OTHER||Mean Difference (Net)|-5.72|||<|0.001|TWO_SIDED|95.0|-8.98|-2.45||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-2.45|-8.98|<0.001
73878788|NCT01601535|147297177|OTHER|||||||0.63||||||UGT1A1 6\\6 vs. UGT1A1 6\\7 vs. UGT1A1 7\\7|Fisher Exact|||||||0.63
73878789|NCT01601535|147297178|OTHER|||||||0.9||||||AurkA Codon 31 Summary H vs. AurkA Codon 31 Summary V vs. AurkA Codon 31 Summary W|Fisher Exact|||||||0.90
73878790|NCT01601535|147297178|OTHER|||||||1||||||AurkA Codon 57 Summary H vs. AurkA Codon 57 Summary W|Fisher Exact|||||||1.0
73878791|NCT01787461|147297185|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.14||||0.358|TWO_SIDED|95.0|-0.16|0.44|||ANOVA|||Change at Week 24: Analysis was performed using an analysis of variance (ANOVA) model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.44|-0.16|0.358
73878792|NCT01787461|147297186|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.037||||0.568|TWO_SIDED|95.0|-0.19|0.27|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for Glogau classification of photoaging and site.||0.27|-0.19|0.568
73878793|NCT01787461|147297187|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.797|TWO_SIDED|95.0|-0.25|0.33|||ANOVA|||Change at Week 12: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.33|-0.25|0.797
73878794|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.965|TWO_SIDED|95.0|-0.29|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.29|0.965
73878795|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.674|TWO_SIDED|95.0|-0.2|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.20|0.674
73878796|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.916|TWO_SIDED|95.0|-0.35|0.32|||ANOVA|||Change at Week 12, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.32|-0.35|0.916
73878797|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.915|TWO_SIDED|95.0|-0.39|0.35|||ANOVA|||Change at Week 12, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.35|-0.39|0.915
73878798|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.672|TWO_SIDED|95.0|-0.4|0.26|||ANOVA|||Change at Week 12, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.26|-0.40|0.672
73878799|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.655|TWO_SIDED|95.0|-0.27|0.43|||ANOVA|||Change at Week 12, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.27|0.655
73878800|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.561|TWO_SIDED|95.0|-0.23|0.43|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.23|0.561
73878801|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.356|TWO_SIDED|95.0|-0.14|0.4|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.40|-0.14|0.356
74092138|NCT02504671|147737900|OTHER||Mean Difference (Net)|-2.51||||0.518|TWO_SIDED|95.0|-10.13|5.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||5.12|-10.13|0.518
74039985|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0133|TWO_SIDED|95.0|-0.82|-0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.82|0.0133
74092139|NCT02504671|147737900|OTHER||Mean Difference (Net)|-2.0||||0.599|TWO_SIDED|95.0|-9.5|5.49||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||5.49|-9.50|0.599
74092140|NCT02504671|147737900|OTHER||Mean Difference (Net)|-12.63||||0.015|TWO_SIDED|95.0|-22.78|-2.48||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-2.48|-22.78|0.015
74092141|NCT02504671|147737900|OTHER||Mean Difference (Net)|-17.18|||<|0.001|TWO_SIDED|95.0|-27.27|-7.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-7.10|-27.27|<0.001
74092142|NCT02504671|147737900|OTHER||Mean Difference (Net)|-2.98||||0.054|TWO_SIDED|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.05|-6.00|0.054
74092143|NCT02504671|147737900|OTHER||Mean Difference (Net)|-6.04|||<|0.001|TWO_SIDED|95.0|-9.05|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||-3.02|-9.05|<0.001
74092144|NCT02504671|147737900|OTHER||Mean Difference (Net)|-3.63||||0.031|TWO_SIDED|95.0|-6.92|-0.33||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-0.33|-6.92|0.031
74092145|NCT02504671|147737900|OTHER||Mean Difference (Net)|-6.32|||<|0.001|TWO_SIDED|95.0|-9.61|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-3.02|-9.61|<0.001
74092146|NCT02504671|147737901|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092147|NCT02504671|147737901|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
74092148|NCT02504671|147737901|OTHER||Difference|-5.4|||||TWO_SIDED|95.0|-12.7|1.9|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||1.9|-12.7|
74092149|NCT02504671|147737901|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
74092150|NCT02504671|147737901|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092151|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092152|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092153|NCT02504671|147737901|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092154|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092155|NCT02504671|147737901|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
74092156|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092157|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092158|NCT02504671|147737901|OTHER||Difference|27.0|||||TWO_SIDED|95.0|12.7|41.3|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.3|12.7|
74092159|NCT02504671|147737901|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092160|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092161|NCT02504671|147737901|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092162|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
73878802|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.669|TWO_SIDED|95.0|-0.28|0.43|||ANOVA|||Change at Week 24, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.28|0.669
73878803|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.954|TWO_SIDED|95.0|-0.32|0.34|||ANOVA|||Change at Week 24, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.34|-0.32|0.954
73878804|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.684|TWO_SIDED|95.0|-0.34|0.22|||ANOVA|||Change at Week 24, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.22|-0.34|0.684
73878805|NCT01787461|147297188|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.886|TWO_SIDED|95.0|-0.35|0.3|||ANOVA|||Change at Week 24, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.35|0.886
73878806|NCT01787461|147297189|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.901|TWO_SIDED|95.0|-0.33|0.37|||ANOVA|||Change at Week 12, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.37|-0.33|0.901
74039986|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.2||0.2157|TWO_SIDED|95.0|-0.65|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.65|0.2157
74092163|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
73878807|NCT01787461|147297189|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.399|TWO_SIDED|95.0|-0.19|0.47|||ANOVA|||Change at Week 12, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.47|-0.19|0.399
73878808|NCT01787461|147297189|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.875|TWO_SIDED|95.0|-0.38|0.32|||ANOVA|||Change at Week 12, Back of Hands-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.32|-0.38|0.875
74039987|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.2||0.0781|TWO_SIDED|95.0|-0.76|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.76|0.0781
73878809|NCT01787461|147297189|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.005|TWO_SIDED|95.0|0.13|0.73|||ANOVA|||Change at Week 12, Back of Hands-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.73|0.13|0.005
73878810|NCT01787461|147297189|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.876|TWO_SIDED|95.0|-0.33|0.38|||ANOVA|||Change at Week 24, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.33|0.876
73878811|NCT01787461|147297189|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.789|TWO_SIDED|95.0|-0.29|0.38|||ANOVA|||Change at Week 24, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.29|0.789
73878812|NCT01787461|147297189|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.901|TWO_SIDED|95.0|-0.31|0.38|||ANOVA|||Change at Week 24, Back of Hands- Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.31|0.901
73878813|NCT01787461|147297189|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.027|TWO_SIDED|95.0|0.04|0.72|||ANOVA|||Change at Week 24, Back of Hands - Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.72|0.04|0.027
73878814|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.083||||0.688|TWO_SIDED|95.0|-0.1|0.27|||Cochran-Mantel-Haenszel|||Improvement Week 12, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.27|-0.10|0.688
73878815|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.121||||0.445|TWO_SIDED|95.0|-0.08|0.33|||Cochran-Mantel-Haenszel|||Improvement Week 12, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.33|-0.08|0.445
73878816|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.205||||0.318|TWO_SIDED|95.0|0.01|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.40|0.01|0.318
73878817|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.012||||0.633|TWO_SIDED|95.0|-0.15|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.15|0.633
74039988|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3527|TWO_SIDED|95.0|-0.62|0.22|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.22|-0.62|0.3527
73878818|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.018||||0.996|TWO_SIDED|95.0|-0.23|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 12, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.19|-0.23|0.996
74009292|NCT04667377|147569399|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|21.02|||<|0.0001|TWO_SIDED|95.0|6.47|68.28||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||68.28|6.47|<.0001
73878819|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.059||||0.432|TWO_SIDED|95.0|-0.13|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.25|-0.13|0.432
74009293|NCT04667377|147569400|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-4.53|STANDARD_ERROR_OF_MEAN|1.48||0.0025|TWO_SIDED|95.0|-7.44|-1.61||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-1.61|-7.44|0.0025
74009294|NCT04667377|147569400|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.07|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-14.94|-9.19||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-9.19|-14.94|<.0001
74009295|NCT04667377|147569400|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.96|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|95.0|-15.85|-10.07||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo at week 46.|No formal hypotheses were tested.||-10.07|-15.85|<.0001
74009296|NCT04667377|147569400|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-15.78|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|95.0|-18.67|-12.9||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo at week 46.|No formal hypotheses were tested.||-12.90|-18.67|<.0001
74009297|NCT04667377|147569401|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-4.36|STANDARD_ERROR_OF_MEAN|1.71||0.0116|TWO_SIDED|95.0|-7.74|-0.98||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.98|-7.74|0.0116
74009298|NCT04667377|147569401|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-11.03|STANDARD_ERROR_OF_MEAN|1.71|<|0.0001|TWO_SIDED|95.0|-14.39|-7.66||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.66|-14.39|<.0001
74009299|NCT04667377|147569401|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-11.0|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-14.33|-7.67||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.67|-14.33|<.0001
74039989|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.2994|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.2994
74039990|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.22||0.3326|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.63|0.3326
73878820|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.03||||0.833|TWO_SIDED|95.0|-0.13|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 24, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.19|-0.13|0.833
73878821|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.226||||0.171|TWO_SIDED|95.0|0.06|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.39|0.06|0.171
73878822|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.02||||0.796|TWO_SIDED|95.0|-0.16|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 24, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.16|0.796
73878823|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.033||||0.942|TWO_SIDED|95.0|-0.23|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.16|-0.23|0.942
74009300|NCT04667377|147569401|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.05|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-15.39|-8.71||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-8.71|-15.39|<.0001
74039991|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.2822|TWO_SIDED|95.0|-0.65|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.65|0.2822
74039992|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.22||0.4932|TWO_SIDED|95.0|-0.57|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.57|0.4932
74039993|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.22||0.4571|TWO_SIDED|95.0|-0.58|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.26|-0.58|0.4571
74092164|NCT02504671|147737901|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092165|NCT02504671|147737901|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
73878824|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.118||||0.405|TWO_SIDED|95.0|-0.05|0.28|||Cochran-Mantel-Haenszel|||Improvement Week 24, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.28|-0.05|0.405
73878825|NCT01787461|147297190|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.061||||0.687|TWO_SIDED|95.0|-0.14|0.26|||Cochran-Mantel-Haenszel|||Improvement Week 24, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.26|-0.14|0.687
73878826|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.384||||0.017|TWO_SIDED|95.0|0.23|0.54|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.54|0.23|0.017
73878827|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.248||||0.073|TWO_SIDED|95.0|0.09|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.40|0.09|0.073
73878828|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.057||||0.117|TWO_SIDED|95.0|-0.11|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.22|-0.11|0.117
73878829|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.096||||0.662|TWO_SIDED|95.0|-0.31|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.31|0.662
73878830|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.1||||0.373|TWO_SIDED|95.0|-0.05|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.25|-0.05|0.373
73887946|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|16.4|||<|0.0001|TWO_SIDED|95.0|8.7|24.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.1|8.7|<0.0001
74092166|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092167|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
73878831|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.031||||0.294|TWO_SIDED|95.0|-0.19|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.19|0.294
73878832|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.035||||0.857|TWO_SIDED|95.0|-0.2|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 12, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.20|0.857
73878833|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.206||||0.088|TWO_SIDED|95.0|0.02|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.39|0.02|0.088
73878834|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.193||||0.11|TWO_SIDED|95.0|-0.02|0.41|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.41|-0.02|0.110
73878835|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.205||||0.112|TWO_SIDED|95.0|0.07|0.34|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.34|0.07|0.112
73878836|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.003||||0.614|TWO_SIDED|95.0|-0.13|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.13|0.614
73878837|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.011||||0.693|TWO_SIDED|95.0|-0.18|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.16|-0.18|0.693
74039994|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.22||0.5586|TWO_SIDED|95.0|-0.56|0.3|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.30|-0.56|0.5586
74092168|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092169|NCT02504671|147737901|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
74092170|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
73878838|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.079||||0.762|TWO_SIDED|95.0|-0.06|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.22|-0.06|0.762
73878839|NCT01787461|147297191|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.013||||0.662|TWO_SIDED|95.0|-0.16|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.16|0.662
73878840|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|3.93||||0.587|TWO_SIDED|95.0|-10.32|18.18|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||18.18|-10.32|0.587
73878841|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.08||||0.814|TWO_SIDED|95.0|-14.49|12.32|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||12.32|-14.49|0.814
73878842|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.57||||0.453|TWO_SIDED|95.0|-16.14|8.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||8.99|-16.14|0.453
73878843|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.16||||0.191|TWO_SIDED|95.0|-22.92|4.61|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.61|-22.92|0.191
73878844|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.685|TWO_SIDED|95.0|-10.07|15.28|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||15.28|-10.07|0.685
73878845|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|5.74||||0.48|TWO_SIDED|95.0|-11.67|23.15|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||23.15|-11.67|0.480
73878846|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.98||||0.299|TWO_SIDED|95.0|-17.29|5.34|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||5.34|-17.29|0.299
74039995|NCT02528253|147632465|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.22||0.2664|TWO_SIDED|95.0|-0.67|0.19|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.67|0.2664
74039996|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|2.14||||0.001|TWO_SIDED|95.0|1.36|3.36|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.36|1.36|0.0010
73878847|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.07||||0.107|TWO_SIDED|95.0|-20.04|1.9|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.90|-20.04|0.107
74009301|NCT04667377|147569402|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-3.73|STANDARD_ERROR_OF_MEAN|2.08||0.0733|TWO_SIDED|95.0|-7.82|0.35||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||0.35|-7.82|0.0733
74009302|NCT04667377|147569402|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-5.62|STANDARD_ERROR_OF_MEAN|2.08|<|0.0072|TWO_SIDED|95.0|-9.71|1.53||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||1.53|-9.71|<.0072
74009303|NCT04667377|147569402|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-6.2|STANDARD_ERROR_OF_MEAN|2.05||0.0027|TWO_SIDED|95.0|-10.23|-2.17||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-2.17|-10.23|0.0027
74009304|NCT04667377|147569402|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-6.16|STANDARD_ERROR_OF_MEAN|2.08||0.0033|TWO_SIDED|95.0|-10.25|-2.06||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-2.06|-10.25|0.0033
74009305|NCT04667377|147569403|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-1.44|STANDARD_ERROR_OF_MEAN|1.26||0.2569|TWO_SIDED|95.0|-3.92|1.05||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||1.05|-3.92|0.2569
74009306|NCT04667377|147569403|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.49|STANDARD_ERROR_OF_MEAN|1.26||0.0495|TWO_SIDED|95.0|-4.97|0.0||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.00|-4.97|0.0495
74009307|NCT04667377|147569403|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.44|STANDARD_ERROR_OF_MEAN|1.24||0.0506|TWO_SIDED|95.0|-4.9|0.01||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 -placebo.|No formal hypotheses were tested.||0.01|-4.90|0.0506
74039997|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|2.68|||<|0.0001|TWO_SIDED|95.0|1.73|4.16|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||4.16|1.73|<.0001
74039998|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.62||||0.03|TWO_SIDED|95.0|1.05|2.51|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.51|1.05|0.0300
74039999|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.0001|TWO_SIDED|95.0|1.44|2.86|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.86|1.44|<.0001
74092171|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092172|NCT02504671|147737901|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092173|NCT02504671|147737901|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
73878848|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.82||||0.776|TWO_SIDED|95.0|-14.39|10.76|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||10.76|-14.39|0.776
73878849|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.33||||0.603|TWO_SIDED|95.0|-15.96|9.29|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||9.29|-15.96|0.603
73878850|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.82||||0.51|TWO_SIDED|95.0|-15.23|7.6|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||7.60|-15.23|0.510
73878851|NCT01787461|147297192|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.75||||0.225|TWO_SIDED|95.0|-17.7|4.2|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.20|-17.70|0.225
73878852|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.214|TWO_SIDED|95.0|-0.46|2.02|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.02|-0.46|0.214
73878853|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.027|TWO_SIDED|95.0|0.12|2.09|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.09|0.12|0.027
73878854|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99||||0.049|TWO_SIDED|95.0|0.01|1.96|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.96|0.01|0.049
73878855|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.019|TWO_SIDED|95.0|0.2|2.14|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.14|0.20|0.019
74040000|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|2.37|||<|0.0001|TWO_SIDED|95.0|1.69|3.32|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.32|1.69|<.0001
74040001|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.44||||0.029|TWO_SIDED|95.0|1.04|1.99|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.99|1.04|0.0290
74040002|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0003|TWO_SIDED|95.0|1.31|2.47|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.47|1.31|0.0003
74040003|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.62|3.03|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.03|1.62|<.0001
74040004|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0033|TWO_SIDED|95.0|1.16|2.1|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.10|1.16|0.0033
74092174|NCT02504671|147737901|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
73878856|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.449|TWO_SIDED|95.0|-0.36|0.8|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.80|-0.36|0.449
73878857|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.105|TWO_SIDED|95.0|-0.07|0.8|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.80|-0.07|0.105
74040005|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0179|TWO_SIDED|95.0|1.06|1.88|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.88|1.06|0.0179
74040006|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0021|TWO_SIDED|95.0|1.18|2.08|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.08|1.18|0.0021
74092175|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092176|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
73878858|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.205|TWO_SIDED|95.0|-0.14|0.68|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.68|-0.14|0.205
73878859|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.1|TWO_SIDED|95.0|-0.06|0.77|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.77|-0.06|0.100
74040007|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.06||||0.6629|TWO_SIDED|95.0|0.81|1.38|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.38|0.81|0.6629
74040008|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0251|TWO_SIDED|95.0|1.04|1.75|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.75|1.04|0.0251
74092177|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
73878860|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.244|TWO_SIDED|95.0|-0.17|0.66|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.66|-0.17|0.244
73878861|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.594|TWO_SIDED|95.0|-0.32|0.56|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.56|-0.32|0.594
73878862|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.317|TWO_SIDED|95.0|-0.2|0.63|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.63|-0.20|0.317
73878863|NCT01787461|147297193|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.264|TWO_SIDED|95.0|-0.17|0.64|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.64|-0.17|0.264
73878864|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.16||||0.266|TWO_SIDED|95.0|-69.63|19.31|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||19.31|-69.63|0.266
73878865|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.79||||0.21|TWO_SIDED|95.0|-73.99|16.41|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||16.41|-73.99|0.210
73878866|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.78||||0.753|TWO_SIDED|95.0|-56.55|40.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||40.99|-56.55|0.753
73878867|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.9||||0.632|TWO_SIDED|95.0|-76.32|46.51|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||46.51|-76.32|0.632
73878868|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|4.54||||0.715|TWO_SIDED|95.0|-19.94|29.01|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||29.01|-19.94|0.715
73878869|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|6.35||||0.648|TWO_SIDED|95.0|-21.04|33.75|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||33.75|-21.04|0.648
73878870|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.49||||0.315|TWO_SIDED|95.0|-48.81|15.83|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||15.83|-48.81|0.315
73878871|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|14.42||||0.402|TWO_SIDED|95.0|-19.5|48.34|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||48.34|-19.50|0.402
74040009|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1278|TWO_SIDED|95.0|0.94|1.59|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.59|0.94|0.1278
74092178|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
73878872|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|12.43||||0.381|TWO_SIDED|95.0|-15.49|40.35|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||40.35|-15.49|0.381
73887947|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|27.4|||<|0.0001|TWO_SIDED|95.0|19.7|35.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.0|19.7|<0.0001
74040010|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.27||||0.0749|TWO_SIDED|95.0|0.98|1.65|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.65|0.98|0.0749
74040011|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0633|TWO_SIDED|95.0|0.99|1.66|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.66|0.99|0.0633
74040012|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0626|TWO_SIDED|95.0|0.99|1.67|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.67|0.99|0.0626
74040013|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2727|TWO_SIDED|95.0|0.89|1.51|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.51|0.89|0.2727
74040014|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1749|TWO_SIDED|95.0|0.92|1.57|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.57|0.92|0.1749
74040015|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5239|TWO_SIDED|95.0|0.84|1.42|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.42|0.84|0.5239
73878873|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|1.49||||0.916|TWO_SIDED|95.0|-26.44|29.43|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||29.43|-26.44|0.916
73878874|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.88||||0.566|TWO_SIDED|95.0|-43.81|24.05|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||24.05|-43.81|0.566
73878875|NCT01787461|147297194|SUPERIORITY_OR_OTHER||LS Mean Difference|8.58||||0.667|TWO_SIDED|95.0|-30.78|47.94|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||47.94|-30.78|0.667
73878876|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.458|TWO_SIDED|95.0|-2.21|1.0|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.00|-2.21|0.458
74009308|NCT04667377|147569403|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.93|STANDARD_ERROR_OF_MEAN|1.25||0.0202|TWO_SIDED|95.0|-5.4|-0.46||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.46|-5.40|0.0202
74009309|NCT01011439|147569404|SUPERIORITY||Single proportion|0.44|||<|0.001|TWO_SIDED|95.0|0.31|0.59|||Fisher Exact|||H0:p\</=17% vs. H1:p\>17%, with an interesting PFS-3 rate of 33% or higher; Power=80%; Alpha(1-sided)=5%, 54 evaluable patients are required for a Simon optimal two stage design trial. If at least 4 successes among the first 17 evaluable patients are observed in the 1st stage, patients' enrollment proceed up to the final analysis where at least 14/54 successes (PFS-3 rate ≥ 25.9%) must be required to reject the null hypothesis.||0.59|0.31|<0.001
74009310|NCT01312038|147569421|SUPERIORITY_OR_OTHER||||||=|0.93|||||||Paired T-test|df=34||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of -200 daPa.||||=0.93
74009311|NCT01312038|147569421|SUPERIORITY_OR_OTHER||||||=|0.39|||||||Paired T-test|df = 31||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of 200 daPa.||||=0.39
74009312|NCT02665052|147569454|SUPERIORITY|||||||0.64||||||The primary analysis was a two sample t-test (alpha=0.05) of the mean WMFT log-time change at 6 weeks. The threshold for statistical significance was p-value = 0.05.|t-test, 2 sided|||78 participants were needed to generate a sample size of 22 per group and provide 80% power to detect a between group difference in mean Wolf time change (6 week - baseline) based on an a priori assumption of a mean change of 0 and 7.4 seconds respectively for the delayed entry usual care control and home-based BATRAC group; a SD of 7.6 and discontinuation rate of 15%.||||0.64
74009313|NCT02665052|147569455|SUPERIORITY|||||||0.01||||||The lab-based group had significant within group mean Fugl-Meyer (FM) change at week 6.|ANOVA|Dunnett's adjustments were used to compare the active intervention changes to the delayed-entry usual care control group.||Within group changes from baseline to week 6 were assessed using analysis of variance.||||0.01
74092179|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
73878877|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53||||0.497|TWO_SIDED|95.0|-2.07|1.01|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.01|-2.07|0.497
73878878|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.113|TWO_SIDED|95.0|-3.05|0.33|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.33|-3.05|0.113
74092180|NCT02504671|147737901|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
73878879|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.708|TWO_SIDED|95.0|-2.11|1.44|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.44|-2.11|0.708
73878880|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24||||0.495|TWO_SIDED|95.0|-2.34|4.82|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.82|-2.34|0.495
73878881|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.85||||0.243|TWO_SIDED|95.0|-4.96|1.27|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.27|-4.96|0.243
73878882|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.453|TWO_SIDED|95.0|-4.96|2.23|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.23|-4.96|0.453
74092181|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092182|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092183|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092184|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
73878883|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55||||0.745|TWO_SIDED|95.0|-2.79|3.89|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||3.89|-2.79|0.745
73878884|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.987|TWO_SIDED|95.0|-2.44|2.48|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.48|-2.44|0.987
73878885|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.42||||0.218|TWO_SIDED|95.0|-3.69|0.85|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.85|-3.69|0.218
74009314|NCT02665052|147569455|SUPERIORITY|||||||0.97|||||||ANOVA|||FM change was analyzed using analysis of variance followed by Dunnett's adjustment for between group comparisons in the home-based BATRAC group compared to the delayed-entry control.||||0.97
74092185|NCT02504671|147737901|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
74092186|NCT02504671|147737901|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092187|NCT02504671|147737901|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092188|NCT02504671|147737901|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
73878886|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67||||0.63|TWO_SIDED|95.0|-3.41|2.08|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.08|-3.41|0.630
73878887|NCT01787461|147297195|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.576|TWO_SIDED|95.0|-2.06|3.68|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||3.68|-2.06|0.576
74092189|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092190|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092191|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092192|NCT02504671|147737901|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
73878888|NCT04879628|147297196|SUPERIORITY||Rate ratio|0.21|||||TWO_SIDED|95.0|0.08|0.56||||||Negative binomial regression model adjusting for the categorical baseline GdE T1 lesion count (presence/absence) as covariate, treatment as factor, with offset equal to the log of the duration (in months) between the Week 12 MRI and previous MRI at Week 8.||0.56|0.08|
73878889|NCT04879628|147297196|SUPERIORITY||Rate ratio|0.11|||||TWO_SIDED|95.0|0.03|0.38||||||Negative binomial regression model adjusting for the categorical baseline GdE T1 lesion count (presence/absence) as covariate, treatment as factor, with offset equal to the log of the duration (in months) between the Week 12 MRI and previous MRI at Week 8.||0.38|0.03|
73878890|NCT04612725|147297232|SUPERIORITY||LS mean difference|-1.01||||0.3824|TWO_SIDED|95.0|-3.28|1.26||Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.26|-3.28|0.3824
73878891|NCT04612725|147297232|SUPERIORITY||LS mean difference|-1.79||||0.1244|TWO_SIDED|95.0|-4.09|0.5||Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.50|-4.09|0.1244
74009315|NCT02665052|147569456|SUPERIORITY|||||||0.31|||||||ANOVA|||Within group SIS hand changes from baseline to week 6 were assessed using analysis of variance followed by comparisons to the delayed-entry usual care control using Dunnett's adjustment.||||0.31
74092193|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
74092194|NCT02504671|147737901|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092195|NCT02504671|147737901|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092196|NCT02504671|147737901|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74092197|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092198|NCT02504671|147737901|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092199|NCT02504671|147737901|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
74092200|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092201|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092202|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092203|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092204|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092205|NCT02504671|147737901|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
74092206|NCT02504671|147737901|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
73878892|NCT04612725|147297233|SUPERIORITY||LS mean difference|-2.07||||0.4016|TWO_SIDED|95.0|-6.95|2.8||Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.80|-6.95|0.4016
74092207|NCT02504671|147737901|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092208|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092209|NCT02504671|147737901|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
73878893|NCT04612725|147297233|SUPERIORITY||LS mean difference|-4.36||||0.0819|TWO_SIDED|95.0|-9.28|0.56||Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.56|-9.28|0.0819
73878894|NCT04612725|147297233|SUPERIORITY||LS mean difference|-2.56||||0.3314|TWO_SIDED|95.0|-7.74|2.63||Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.63|-7.74|0.3314
73878895|NCT04612725|147297233|SUPERIORITY||LS mean difference|-3.74||||0.1582|TWO_SIDED|95.0|-8.95|1.47||Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.47|-8.95|0.1582
74092210|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092211|NCT02504671|147737901|OTHER||Difference|24.3|||||TWO_SIDED|95.0|10.5|38.1|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.1|10.5|
74092212|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092213|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092214|NCT02504671|147737901|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092215|NCT02504671|147737901|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
73878896|NCT04612725|147297234|SUPERIORITY||LS mean difference|-1.62||||0.1995|TWO_SIDED|95.0|-4.1|0.86||Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.86|-4.10|0.1995
73878897|NCT04612725|147297234|SUPERIORITY||LS mean difference|-1.76||||0.1654|TWO_SIDED|95.0|-4.25|0.73||Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.73|-4.25|0.1654
73878898|NCT04612725|147297235|SUPERIORITY||percentage difference|11.72||||0.1373|TWO_SIDED|95.0|-2.37|25.82||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||25.82|-2.37|0.1373
74092216|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092217|NCT02504671|147737901|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092218|NCT02504671|147737901|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
74092219|NCT02504671|147737901|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092220|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.32||||0.046|TWO_SIDED|95.0|-0.64|-0.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.01|-0.64|0.046
74092221|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.3||||0.071|TWO_SIDED|95.0|-0.62|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||0.03|-0.62|0.071
74092222|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.37||||0.022|TWO_SIDED|95.0|-0.69|-0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.05|-0.69|0.022
74092223|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.28||||0.16|TWO_SIDED|95.0|-0.67|0.11||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||0.11|-0.67|0.160
74092224|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.32||||0.103|TWO_SIDED|95.0|-0.71|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||0.07|-0.71|0.103
74092225|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.42||||0.034|TWO_SIDED|95.0|-0.8|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.03|-0.80|0.034
74092226|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.4||||0.096|TWO_SIDED|95.0|-0.87|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||0.07|-0.87|0.096
73878899|NCT04612725|147297235|SUPERIORITY||percentage difference|10.73||||0.1697|TWO_SIDED|95.0|-3.42|24.88||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||24.88|-3.42|0.1697
73878900|NCT04612725|147297235|SUPERIORITY||percentage difference|1.03||||0.9105|TWO_SIDED|95.0|-16.9|18.96||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||18.96|-16.90|0.9105
73878901|NCT04612725|147297235|SUPERIORITY||percentage difference|9.27||||0.3389|TWO_SIDED|95.0|-9.37|27.9||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||27.90|-9.37|0.3389
73878902|NCT04612725|147297236|SUPERIORITY||LS mean difference|-1.16||||0.4203|TWO_SIDED|95.0|-4.0|1.68||Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.68|-4.00|0.4203
73878903|NCT04612725|147297236|SUPERIORITY||LS mean difference|-2.6||||0.0754|TWO_SIDED|95.0|-5.46|0.27||Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.27|-5.46|0.0754
73878904|NCT04612725|147297236|SUPERIORITY||LS mean difference|-1.06||||0.4772|TWO_SIDED|95.0|-4.01|1.89||Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.89|-4.01|0.4772
73878905|NCT04612725|147297236|SUPERIORITY||LS mean difference|-2.0||||0.1851|TWO_SIDED|95.0|-4.96|0.97||Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.97|-4.96|0.1851
73878906|NCT04612725|147297238|SUPERIORITY|||||||0.9678||||||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||||0.9678
73878907|NCT04612725|147297238|SUPERIORITY|||||||0.3689||||||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||||0.3689
73878908|NCT04612725|147297238|SUPERIORITY||percentage difference|-3.43||||0.6624|TWO_SIDED|95.0|-18.96|12.11||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||12.11|-18.96|0.6624
73878909|NCT04612725|147297238|SUPERIORITY||percentage difference|0.28||||0.9726|TWO_SIDED|95.0|-15.84|16.4||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||16.40|-15.84|0.9726
73878910|NCT04612725|147297240|SUPERIORITY||LS mean difference|-0.29||||0.7256|TWO_SIDED|95.0|-1.9|1.32||Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.32|-1.90|0.7256
73878911|NCT04612725|147297240|SUPERIORITY||LS mean difference|1.09||||0.189|TWO_SIDED|95.0|-0.54|2.72||Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.72|-0.54|0.1890
74040016|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3336|TWO_SIDED|95.0|0.87|1.49|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.49|0.87|0.3336
73878912|NCT04612725|147297240|SUPERIORITY||LS mean difference|-0.63||||0.5048|TWO_SIDED|95.0|-2.51|1.24||Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.24|-2.51|0.5048
73878913|NCT04612725|147297240|SUPERIORITY||LS mean difference|0.99||||0.2991|TWO_SIDED|95.0|-0.89|2.88||Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.88|-0.89|0.2991
73878914|NCT04612725|147297241|SUPERIORITY||LS mean difference|1.63||||0.5704|TWO_SIDED|95.0|-4.05|7.32||Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||7.32|-4.05|0.5704
73878915|NCT04612725|147297241|SUPERIORITY||LS mean difference|-2.24||||0.4416|TWO_SIDED|95.0|-7.98|3.5||Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.50|-7.98|0.4416
73878916|NCT04612725|147297241|SUPERIORITY||LS mean difference|1.47||||0.6591|TWO_SIDED|95.0|-5.09|8.02||Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||8.02|-5.09|0.6591
73878917|NCT04612725|147297241|SUPERIORITY||LS mean difference|-3.04||||0.3624|TWO_SIDED|95.0|-9.62|3.54||Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.54|-9.62|0.3624
73878918|NCT04612725|147297242|SUPERIORITY||LS mean difference|0.48||||0.7037|TWO_SIDED|95.0|-2.02|2.98||Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.98|-2.02|0.7037
73878919|NCT04612725|147297242|SUPERIORITY||LS mean difference|-1.25||||0.332|TWO_SIDED|95.0|-3.78|1.29||Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.29|-3.78|0.3320
73878920|NCT04612725|147297242|SUPERIORITY||LS mean difference|1.24||||0.359|TWO_SIDED|95.0|-1.42|3.9||Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.90|-1.42|0.3590
73878921|NCT04612725|147297242|SUPERIORITY||LS mean difference|-0.88||||0.5175|TWO_SIDED|95.0|-3.56|1.8||Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.80|-3.56|0.5175
73878922|NCT02354235|147297262|SUPERIORITY||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.15|-0.6|||ANCOVA|||||-0.60|-1.15|<0.001
74009316|NCT00823823|147569457|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||The frequency of loss of reduction during the study period was compared across casting groups using a two-sided chi-square test with alpha = 0.05.||||1.00
74009317|NCT02234284|147569459|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.35|TWO_SIDED|95.0|-0.15|0.43|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.43|-.15|.35
74009318|NCT02234284|147569460|SUPERIORITY||Mean Difference (Net)|0.26||||0.2|TWO_SIDED|95.0|-0.13|0.65|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.65|-.13|.20
74009319|NCT02234284|147569461|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.13|TWO_SIDED|95.0|-0.49|0.07|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of exacerbations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.07|-0.49|.13
74009320|NCT02234284|147569462|SUPERIORITY||Mean Difference (Final Values)|8.53||||0.32|TWO_SIDED|95.0|-8.18|25.26|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|Value is for mean distance (in meters) of participants in Health Coached arm minus mean distance in Usual Care, adjusted for baseline values and for clustering.|25.26|-8.18|.32
74009321|NCT02234284|147569463|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.27|TWO_SIDED|95.0|-0.23|0.83|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.83|-.23|.27
74040017|NCT02528253|147632467|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2163|TWO_SIDED|95.0|0.91|1.54|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.54|0.91|0.2163
74040018|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.28||||0.326|TWO_SIDED|95.0|0.78|2.08|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.08|0.78|0.3260
74040019|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0445|TWO_SIDED|95.0|1.01|2.56|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.56|1.01|0.0445
74040020|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9263|TWO_SIDED|95.0|0.65|1.61|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.61|0.65|0.9263
74040021|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3194|TWO_SIDED|95.0|0.81|1.94|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.94|0.81|0.3194
74040022|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0308|TWO_SIDED|95.0|1.04|2.38|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.38|1.04|0.0308
74092227|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.56||||0.02|TWO_SIDED|95.0|-1.02|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.09|-1.02|0.020
74092228|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.76||||0.001|TWO_SIDED|95.0|-1.22|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.29|-1.22|0.001
74092229|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.42||||0.11|TWO_SIDED|95.0|-0.93|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.10|-0.93|0.110
73878923|NCT02354235|147297263|SUPERIORITY||Least Squares Mean Difference|-38.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-48.5|-29.2|||ANCOVA|||||-29.2|-48.5|<0.001
73878924|NCT02354235|147297264|SUPERIORITY||Least Squares Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.2|-1.45|||ANCOVA|||||-1.45|-3.20|<0.001
73878925|NCT02354235|147297265|SUPERIORITY||Least Squares Mean Difference|-100.3|STANDARD_ERROR_OF_MEAN|11.1|<|0.001|TWO_SIDED|95.0|-122.2|-78.4|||ANCOVA|||||-78.4|-122.2|<0.001
74092230|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.47||||0.076|TWO_SIDED|95.0|-0.98|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.05|-0.98|0.076
74092231|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.61||||0.02|TWO_SIDED|95.0|-1.11|-0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||-0.10|-1.11|0.020
74092232|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.42||||0.128|TWO_SIDED|95.0|-0.97|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||0.12|-0.97|0.128
74092233|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.78||||0.005|TWO_SIDED|95.0|-1.33|-0.24||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.24|-1.33|0.005
73878926|NCT02354235|147297266|SUPERIORITY||Least Squares Mean Difference|-50.9|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-64.9|-36.9|||ANCOVA|||||-36.9|-64.9|<0.001
73878927|NCT03069352|147297267|SUPERIORITY||Hazard Ratio (HR)|0.749||||0.114|TWO_SIDED|95.0|0.524|1.071|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||1.071|0.524|0.114
73878928|NCT03069352|147297267|SUPERIORITY||Hazard Ratio (HR)|0.743||||0.103|TWO_SIDED|95.0|0.521|1.061|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||1.061|0.521|0.103
74092234|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.82||||0.003|TWO_SIDED|95.0|-1.36|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.29|-1.36|0.003
74092235|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.53||||0.11|TWO_SIDED|95.0|-1.17|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||0.12|-1.17|0.110
73878929|NCT03069352|147297268|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
73878930|NCT03069352|147297268|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73878931|NCT03069352|147297269|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
73878932|NCT03069352|147297269|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73878933|NCT03069352|147297270|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
73878934|NCT03069352|147297270|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73878935|NCT03069352|147297271|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
73878936|NCT03069352|147297271|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
74092236|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.88||||0.008|TWO_SIDED|95.0|-1.53|-0.23||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.23|-1.53|0.008
74092237|NCT02504671|147737902|OTHER||Mean Difference (Net)|-1.24|||<|0.001|TWO_SIDED|95.0|-1.88|-0.6||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.60|-1.88|<0.001
74092238|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.29||||0.5|TWO_SIDED|95.0|-1.15|0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||0.56|-1.15|0.500
73878937|NCT03069352|147297272|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
73878938|NCT03069352|147297272|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73878939|NCT03069352|147297273|OTHER||LS Mean Difference|-4.507|STANDARD_ERROR_OF_MEAN|2.068|||TWO_SIDED|95.0|-8.6|-0.41|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3, Day 1||-0.41|-8.60|
74092239|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.99||||0.021|TWO_SIDED|95.0|-1.83|-0.15||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.15|-1.83|0.021
74092240|NCT02504671|147737902|OTHER||Mean Difference (Net)|-1.0||||0.017|TWO_SIDED|95.0|-1.83|-0.18||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.18|-1.83|0.017
74092241|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.07||||0.871|TWO_SIDED|95.0|-0.98|0.83||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.83|-0.98|0.871
74092242|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.58||||0.19|TWO_SIDED|95.0|-1.46|0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.29|-1.46|0.190
74092243|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.66||||0.13|TWO_SIDED|95.0|-1.51|0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.20|-1.51|0.130
74092244|NCT02504671|147737902|OTHER||Mean Difference (Net)|-1.22||||0.019|TWO_SIDED|95.0|-2.24|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.20|-2.24|0.019
73878940|NCT03069352|147297273|OTHER||LS Mean Difference|-4.923|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|95.0|-10.03|0.19|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1||0.19|-10.03|
74092245|NCT02504671|147737902|OTHER||Mean Difference (Net)|-1.53||||0.002|TWO_SIDED|95.0|-2.51|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.55|-2.51|0.002
74092246|NCT02504671|147737902|OTHER||Mean Difference (Net)|-1.39||||0.005|TWO_SIDED|95.0|-2.34|-0.43||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.43|-2.34|0.005
74092247|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.41||||0.013|TWO_SIDED|95.0|-0.73|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.09|-0.73|0.013
74092248|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.49||||0.003|TWO_SIDED|95.0|-0.8|-0.17||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.17|-0.80|0.003
74092249|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.47||||0.017|TWO_SIDED|95.0|-0.86|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.09|-0.86|0.017
74092250|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.52||||0.009|TWO_SIDED|95.0|-0.9|-0.13||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.13|-0.90|0.009
73878941|NCT03069352|147297273|OTHER||LS Mean Difference|-0.807|STANDARD_ERROR_OF_MEAN|2.609|||TWO_SIDED|95.0|-5.98|4.36|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1||4.36|-5.98|
73878942|NCT03069352|147297273|OTHER||LS Mean Difference|-1.648|STANDARD_ERROR_OF_MEAN|3.176|||TWO_SIDED|95.0|-7.94|4.64|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 day 1||4.64|-7.94|
74092251|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.67||||0.005|TWO_SIDED|95.0|-1.13|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.20|-1.13|0.005
74092252|NCT02504671|147737902|OTHER||Mean Difference (Net)|-1.01|||<|0.001|TWO_SIDED|95.0|-1.48|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.55|-1.48|<0.001
74092253|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.47||||0.073|TWO_SIDED|95.0|-0.99|0.04||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.04|-0.99|0.073
74092254|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.85||||0.001|TWO_SIDED|95.0|-1.36|-0.34||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||-0.34|-1.36|0.001
74092255|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.89||||0.001|TWO_SIDED|95.0|-1.43|-0.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.35|-1.43|0.001
74092256|NCT02504671|147737902|OTHER||Mean Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.65|-0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.56|-1.65|<0.001
74092257|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.68||||0.039|TWO_SIDED|95.0|-1.32|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.03|-1.32|0.039
74092258|NCT02504671|147737902|OTHER||Mean Difference (Net)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.91|-0.63||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.63|-1.91|<0.001
74092259|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.77||||0.073|TWO_SIDED|95.0|-1.61|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||0.07|-1.61|0.073
74092260|NCT02504671|147737902|OTHER||Mean Difference (Net)|-1.11||||0.007|TWO_SIDED|95.0|-1.91|-0.3||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.30|-1.91|0.007
74092261|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.77||||0.083|TWO_SIDED|95.0|-1.65|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.10|-1.65|0.083
74092262|NCT02504671|147737902|OTHER||Mean Difference (Net)|-0.8||||0.059|TWO_SIDED|95.0|-1.63|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.03|-1.63|0.059
74092263|NCT02504671|147737902|OTHER||Mean Difference (Net)|-1.48||||0.003|TWO_SIDED|95.0|-2.46|-0.5||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.50|-2.46|0.003
74092264|NCT02504671|147737902|OTHER||Mean Difference (Net)|-1.82|||<|0.001|TWO_SIDED|95.0|-2.75|-0.89||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.89|-2.75|<0.001
74092265|NCT02504671|147737904|OTHER||Difference|16.2||||0.037|TWO_SIDED|95.0|1.1|31.4|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.4|1.1|0.037
74092266|NCT02504671|147737904|OTHER||Difference|10.8||||0.144|TWO_SIDED|95.0|-3.1|24.7|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|0.144
74009322|NCT02234284|147569464|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.02|TWO_SIDED|95.0|0.07|0.68|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.68|.07|.02
74009323|NCT02234284|147569465|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.4|TWO_SIDED|95.0|-2.78|1.12|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||1.12|-2.78|.40
74009324|NCT02234284|147569466|SUPERIORITY||Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-3.0|3.0|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean percent predicted of participants in Health Coached arm minus mean percent predicted in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||3|-3|.98
74009325|NCT02234284|147569467|SUPERIORITY||Mean Difference (Final Values)|-11.5||||0.3|TWO_SIDED|95.0|-33.3|10.2|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||10.2|-33.3|.30
73887948|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|20.5|||<|0.0001|TWO_SIDED|95.0|12.8|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.2|12.8|<0.0001
74009326|NCT02234284|147569468|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.29|TWO_SIDED|95.0|-2.07|0.62|||Mixed Models Analysis||Value is for mean number of days for participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|||0.62|-2.07|.29
74009327|NCT02234284|147569469|SUPERIORITY||Mean Difference (Final Values)|39.7|||<|0.001|TWO_SIDED|95.0|19.6|59.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||59.8|19.6|<.001
74009328|NCT02234284|147569470|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.38|TWO_SIDED|95.0|-9.5|25.2|||Mixed Models Analysis||Value is for proportion of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||25.2|-9.5|.38
74040023|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0048|TWO_SIDED|95.0|1.2|2.69|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.69|1.20|0.0048
74040024|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0114|TWO_SIDED|95.0|1.12|2.51|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.51|1.12|0.0114
74040025|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7857|TWO_SIDED|95.0|0.71|1.56|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.56|0.71|0.7857
74040026|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0041|TWO_SIDED|95.0|1.18|2.44|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.44|1.18|0.0041
74040027|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0109|TWO_SIDED|95.0|1.11|2.28|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.28|1.11|0.0109
74092267|NCT02504671|147737904|OTHER||Difference|18.9||||0.033|TWO_SIDED|95.0|3.3|34.5|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.5|3.3|0.033
74092268|NCT02504671|147737904|OTHER||Difference|5.4||||0.437|TWO_SIDED|95.0|-11.3|22.2|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||22.2|-11.3|0.437
74092269|NCT02504671|147737904|OTHER||Difference|2.7||||0.755|TWO_SIDED|95.0|-13.5|18.9|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||18.9|-13.5|0.755
74092270|NCT02504671|147737904|OTHER||Difference|24.3||||0.023|TWO_SIDED|95.0|5.2|43.4|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||43.4|5.2|0.023
74092271|NCT02504671|147737904|OTHER||Difference|29.7||||0.006|TWO_SIDED|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|0.006
74092272|NCT02504671|147737904|OTHER||Difference|21.6||||0.039|TWO_SIDED|95.0|2.0|41.2|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|0.039
73878943|NCT03069352|147297273|SUPERIORITY|||||||0.126|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.||||0.126
73878944|NCT03069352|147297274|OTHER||LS Mean Difference|2.917|STANDARD_ERROR_OF_MEAN|4.617|||TWO_SIDED|95.0|-6.23|12.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3 Day 1||12.06|-6.23|
73878945|NCT03069352|147297274|OTHER||LS Mean Difference|13.388|STANDARD_ERROR_OF_MEAN|5.659|||TWO_SIDED|95.0|2.18|24.59|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1||24.59|2.18|
74092273|NCT02504671|147737904|OTHER||Difference|29.7||||0.008|TWO_SIDED|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|0.008
73878946|NCT03069352|147297274|OTHER||LS Mean Difference|7.119|STANDARD_ERROR_OF_MEAN|6.031|||TWO_SIDED|95.0|-4.83|19.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1||19.06|-4.83|
74092274|NCT02504671|147737904|OTHER||Difference|21.6||||0.044|TWO_SIDED|95.0|0.4|42.8|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|0.044
74092275|NCT02504671|147737904|OTHER||Difference|18.9||||0.083|TWO_SIDED|95.0|-2.2|40.0|||Regression, Logistic||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||40.0|-2.2|0.083
74092276|NCT02504671|147737904|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.8|48.3|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.3|5.8|
74092277|NCT02504671|147737904|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-11.2|32.8|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.Wald confidence limits without correction.|||32.8|-11.2|
74092278|NCT02504671|147737904|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.9|5.2|
74092279|NCT02504671|147737904|OTHER||Difference|32.4|||||TWO_SIDED|95.0|10.9|54.0|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||54.0|10.9|
74092280|NCT02504671|147737904|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.9|42.4|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.4|0.9|
74092281|NCT02504671|147737904|OTHER||Difference|29.7|||||TWO_SIDED|95.0|8.9|50.6|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||50.6|8.9|
74092282|NCT02504671|147737904|OTHER||Difference|45.9|||||TWO_SIDED|95.0|25.9|66.0|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||66.0|25.9|
74092283|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-6.8|33.8|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.8|-6.8|
74092284|NCT02504671|147737904|OTHER||Difference|32.4|||||TWO_SIDED|95.0|11.6|53.3|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||53.3|11.6|
74092285|NCT02504671|147737904|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.2|58.5|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||58.5|17.2|
74092286|NCT02504671|147737904|OTHER||Difference|18.9|||||TWO_SIDED|95.0|-0.5|38.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.4|-0.5|
74092287|NCT02504671|147737904|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
74092288|NCT02504671|147737904|OTHER||Difference|48.6|||||TWO_SIDED|95.0|29.2|68.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.1|29.2|
74092289|NCT02504671|147737904|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-3.0|35.4|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.4|-3.0|
74092290|NCT02504671|147737904|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
74092291|NCT02504671|147737904|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.9|57.8|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.8|17.9|
74092292|NCT02504671|147737904|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092293|NCT02504671|147737904|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092294|NCT02504671|147737904|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092295|NCT02504671|147737904|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092296|NCT02504671|147737904|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
74092297|NCT02504671|147737904|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
74092298|NCT02504671|147737904|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092299|NCT02504671|147737904|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092300|NCT02504671|147737904|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
74092301|NCT02504671|147737904|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092302|NCT02504671|147737904|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092303|NCT02504671|147737904|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
74092304|NCT02504671|147737904|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092305|NCT02504671|147737904|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092306|NCT02504671|147737904|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092307|NCT02504671|147737904|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092308|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092309|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092310|NCT02504671|147737904|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092311|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092312|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092313|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
74092314|NCT02504671|147737904|OTHER||Difference|21.6|||||TWO_SIDED|95.0|5.6|37.7|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||37.7|5.6|
74092315|NCT02504671|147737904|OTHER||Difference|18.9|||||TWO_SIDED|95.0|0.2|37.6|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||37.6|0.2|
74092316|NCT02504671|147737904|OTHER||Difference|24.3|||||TWO_SIDED|95.0|5.2|43.4|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||43.4|5.2|
74092317|NCT02504671|147737904|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
74092318|NCT02504671|147737904|OTHER||Difference|51.4|||||TWO_SIDED|95.0|32.2|70.5|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.5|32.2|
74092319|NCT02504671|147737904|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.4|42.8|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|
73878947|NCT03069352|147297274|OTHER||LS Mean Difference|6.381|STANDARD_ERROR_OF_MEAN|7.511|||TWO_SIDED|95.0|-8.49|21.26|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 Day 1||21.26|-8.49|
73878948|NCT03069352|147297274|SUPERIORITY|||||||0.085|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.||||0.085
74040028|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0363|TWO_SIDED|95.0|1.03|2.27|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.27|1.03|0.0363
74040029|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.76||||0.004|TWO_SIDED|95.0|1.2|2.59|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.59|1.20|0.0040
74040030|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.27||||0.1992|TWO_SIDED|95.0|0.88|1.84|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.84|0.88|0.1992
74040031|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3084|TWO_SIDED|95.0|0.85|1.7|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.70|0.85|0.3084
74040032|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0586|TWO_SIDED|95.0|0.99|1.94|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.94|0.99|0.0586
74040033|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.39||||0.063|TWO_SIDED|95.0|0.98|1.97|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.97|0.98|0.0630
74040034|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0347|TWO_SIDED|95.0|1.03|2.04|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.04|1.03|0.0347
74092320|NCT02504671|147737904|OTHER||Difference|40.5|||||TWO_SIDED|95.0|19.9|61.2|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||61.2|19.9|
74092321|NCT02504671|147737904|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.9|5.2|
73878949|NCT03069352|147297275|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.002|TWO_SIDED|95.0|0.416|0.817|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||0.817|0.416|0.002
74040035|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|0.96||||0.79|TWO_SIDED|95.0|0.69|1.33|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.33|0.69|0.7900
74040036|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0207|TWO_SIDED|95.0|1.06|2.0|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.00|1.06|0.0207
74040037|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.51||||0.0093|TWO_SIDED|95.0|1.11|2.07|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.07|1.11|0.0093
74040038|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.39||||0.04|TWO_SIDED|95.0|1.02|1.91|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.91|1.02|0.0400
74040039|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2478|TWO_SIDED|95.0|0.88|1.65|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.65|0.88|0.2478
74040040|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0304|TWO_SIDED|95.0|1.03|1.96|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.96|1.03|0.0304
74092322|NCT02504671|147737904|OTHER||Difference|35.1|||||TWO_SIDED|95.0|13.8|56.5|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.5|13.8|
74092323|NCT02504671|147737904|OTHER||Difference|27.0|||||TWO_SIDED|95.0|6.2|47.9|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||47.9|6.2|
74092324|NCT02504671|147737904|OTHER||Difference|54.1|||||TWO_SIDED|95.0|34.9|73.2|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.2|34.9|
74092325|NCT02504671|147737904|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.9|42.4|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.4|0.9|
74009329|NCT02234284|147569471|SUPERIORITY||Median Difference (Final Values)|2.0||||0.73|TWO_SIDED|95.0|-9.4|13.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||13.4|-9.4|.73
74040041|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.12||||0.4763|TWO_SIDED|95.0|0.81|1.56|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.56|0.81|0.4763
73878950|NCT03069352|147297275|SUPERIORITY||Hazard Ratio (HR)|0.601||||0.003|TWO_SIDED|95.0|0.43|0.839|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||0.839|0.430|0.003
74040042|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0178|TWO_SIDED|95.0|1.07|2.01|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.01|1.07|0.0178
74040043|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5223|TWO_SIDED|95.0|0.8|1.53|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.53|0.80|0.5223
74040044|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.25||||0.1708|TWO_SIDED|95.0|0.91|1.72|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.72|0.91|0.1708
74040045|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6022|TWO_SIDED|95.0|0.79|1.5|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.50|0.79|0.6022
74040046|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0846|TWO_SIDED|95.0|0.96|1.81|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.81|0.96|0.0846
74040047|NCT02528253|147632468|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9626|TWO_SIDED|95.0|0.73|1.39|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.39|0.73|0.9626
74040048|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|1.64||0.6508|TWO_SIDED|95.0|-2.49|3.98|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.98|-2.49|0.6508
74040049|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|1.66||0.9629|TWO_SIDED|95.0|-3.33|3.18|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.18|-3.33|0.9629
74040050|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.57||0.7007|TWO_SIDED|95.0|-2.48|3.69|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.69|-2.48|0.7007
74040051|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|1.58||0.8902|TWO_SIDED|95.0|-3.32|2.88|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.88|-3.32|0.8902
74040052|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|1.53||0.5698|TWO_SIDED|95.0|-3.89|2.15|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.15|-3.89|0.5698
74040053|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.53||0.8464|TWO_SIDED|95.0|-3.32|2.72|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.72|-3.32|0.8464
74040054|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-4.03|STANDARD_ERROR_OF_MEAN|2.39||0.0919|TWO_SIDED|95.0|-8.72|0.66|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.66|-8.72|0.0919
74040055|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-4.76|STANDARD_ERROR_OF_MEAN|2.4||0.0477|TWO_SIDED|95.0|-9.47|-0.05|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-9.47|0.0477
74040056|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|2.3||0.4735|TWO_SIDED|95.0|-6.17|2.87|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.87|-6.17|0.4735
74040057|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|2.26||0.2935|TWO_SIDED|95.0|-6.82|2.06|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.06|-6.82|0.2935
74009330|NCT02234284|147569472|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.7|TWO_SIDED|95.0|-14.0|20.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||20.8|-14.0|.70
74009331|NCT02234284|147569473|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-5.5|5.3|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||5.3|-5.5|.97
74009332|NCT02234284|147569474|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.52|TWO_SIDED|95.0|-0.32|1.28|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of outpatient visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||1.28|-0.32|.52
74009333|NCT02234284|147569475|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.78|TWO_SIDED|95.0|-0.32|0.22|||Mixed Models Analysis||Value is for rate of COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.22|-0.32|.78
74009334|NCT02234284|147569476|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.8|TWO_SIDED|95.0|-0.56|0.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.40|-0.56|.80
74040058|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-3.11|STANDARD_ERROR_OF_MEAN|2.27||0.1714|TWO_SIDED|95.0|-7.56|1.35|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.35|-7.56|0.1714
74040059|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|2.75||0.7521|TWO_SIDED|95.0|-6.3|4.56|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.56|-6.30|0.7521
74040060|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-2.81|STANDARD_ERROR_OF_MEAN|2.75||0.3078|TWO_SIDED|95.0|-8.24|2.61|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.61|-8.24|0.3078
74040061|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-3.95|STANDARD_ERROR_OF_MEAN|2.46||0.109|TWO_SIDED|95.0|-8.78|0.88|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.88|-8.78|0.1090
74092326|NCT02504671|147737904|OTHER||Difference|51.4|||||TWO_SIDED|95.0|31.8|70.9|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.9|31.8|
74092327|NCT02504671|147737904|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
74040062|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-5.41|STANDARD_ERROR_OF_MEAN|2.47||0.0289|TWO_SIDED|95.0|-10.27|-0.56|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.56|-10.27|0.0289
74040063|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|2.37||0.4613|TWO_SIDED|95.0|-6.41|2.91|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.91|-6.41|0.4613
74092328|NCT02504671|147737904|OTHER||Difference|56.8|||||TWO_SIDED|95.0|38.2|75.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||75.4|38.2|
74092329|NCT02504671|147737904|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
74040064|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|2.33||0.346|TWO_SIDED|95.0|-6.78|2.38|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.38|-6.78|0.3460
74040065|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|2.34||0.1179|TWO_SIDED|95.0|-8.26|0.93|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.93|-8.26|0.1179
74040066|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-1.93|STANDARD_ERROR_OF_MEAN|2.97||0.5151|TWO_SIDED|95.0|-7.78|3.92|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.92|-7.78|0.5151
74040067|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|2.96||0.255|TWO_SIDED|95.0|-9.22|2.46|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.46|-9.22|0.2550
74040068|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-4.18|STANDARD_ERROR_OF_MEAN|1.73||0.0157|TWO_SIDED|95.0|-7.57|-0.79|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.79|-7.57|0.0157
74040069|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-4.18|STANDARD_ERROR_OF_MEAN|1.73||0.0159|TWO_SIDED|95.0|-7.57|-0.78|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.78|-7.57|0.0159
74040070|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|1.62||0.0896|TWO_SIDED|95.0|-5.94|0.43|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.43|-5.94|0.0896
74040071|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|1.6||0.3749|TWO_SIDED|95.0|-4.57|1.72|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.72|-4.57|0.3749
74040072|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|1.59||0.3733|TWO_SIDED|95.0|-4.55|1.71|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.71|-4.55|0.3733
74040073|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|2.17||0.8056|TWO_SIDED|95.0|-4.8|3.73|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.73|-4.80|0.8056
74092330|NCT02504671|147737904|OTHER||Difference|54.1|||||TWO_SIDED|95.0|35.1|73.0|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.0|35.1|
74092331|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092332|NCT02504671|147737904|OTHER||Difference|75.7|||||TWO_SIDED|95.0|61.4|89.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||89.9|61.4|
74092333|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092334|NCT02504671|147737904|OTHER||Difference|70.3|||||TWO_SIDED|95.0|55.0|85.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||85.5|55.0|
74040074|NCT02528253|147632472|SUPERIORITY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|2.08||0.5764|TWO_SIDED|95.0|-5.25|2.93|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.93|-5.25|0.5764
74040075|NCT02528253|147632473|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7366|TWO_SIDED|95.0|0.62|1.41|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.41|0.62|0.7366
74040076|NCT02528253|147632473|SUPERIORITY||Odds Ratio (OR)|1.06||||0.771|TWO_SIDED|95.0|0.71|1.58|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.71|0.7710
74040077|NCT02528253|147632474|SUPERIORITY|||||||0.4724|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.4724
74040078|NCT02528253|147632474|SUPERIORITY|||||||0.7142|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.7142
74092335|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092336|NCT02504671|147737904|OTHER||Difference|70.3|||||TWO_SIDED|95.0|55.0|85.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||85.5|55.0|
74092337|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092338|NCT02504671|147737904|OTHER||Difference|62.2|||||TWO_SIDED|95.0|45.9|78.4|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||78.4|45.9|
74092339|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
73878951|NCT03069352|147297276|SUPERIORITY||Treatment Difference|22.9||||0.001|TWO_SIDED|95.0|10.8|35.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo|||35.0|10.8|0.001
73878952|NCT03069352|147297276|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73878953|NCT03069352|147297277|SUPERIORITY||Treatment Difference|15.2||||0.04|TWO_SIDED|95.0|1.4|29.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo|||29.0|1.4|0.040
73878954|NCT03069352|147297277|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
73878955|NCT03069352|147297278|SUPERIORITY||Treatment Difference|22.4|||||TWO_SIDED|95.0|9.0|35.8||||||||35.8|9.0|
73878956|NCT03069352|147297279|SUPERIORITY||Slope|17.7|||||TWO_SIDED|95.0|-0.4|35.8||||||||35.8|-0.4|
73878957|NCT03069352|147297280|SUPERIORITY|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||0.162
73878958|NCT03069352|147297280|SUPERIORITY|||||||0.277|||||||Fisher Exact|||||||0.277
73878959|NCT03069352|147297281|SUPERIORITY|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||0.162
73878960|NCT03069352|147297281|SUPERIORITY|||||||0.277|||||||Fisher Exact|||||||0.277
73878961|NCT03069352|147297285|OTHER||Hazard Ratio (HR)|0.704||||0.04|TWO_SIDED|95.0|0.503|0.985|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||0.985|0.503|0.040
73878962|NCT03069352|147297285|OTHER||Hazard Ratio (HR)|0.717||||0.049|TWO_SIDED|95.0|0.514|1.0|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||1.000|0.514|0.049
74040079|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.12||||0.396|TWO_SIDED|95.0|0.87|1.44|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.44|0.87|0.3960
74092340|NCT02504671|147737904|OTHER||Difference|56.8|||||TWO_SIDED|95.0|40.1|73.4|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.4|40.1|
74092341|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74009335|NCT02234284|147569477|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.35|TWO_SIDED|95.0|-0.32|0.06|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of COPD-related hospital visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.06|-0.32|.35
74009336|NCT02234284|147569478|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.37|TWO_SIDED|95.0|-0.2|0.04|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related hospitalizations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.04|-0.20|.37
74009337|NCT02234284|147569479|SUPERIORITY||difference in proportion|-18.9||||0.01|TWO_SIDED|95.0|-33.1|-4.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||-4.8|-33.1|.01
74009338|NCT02234284|147569480|SUPERIORITY||Mean Difference (Final Values)|14.6||||0.01|TWO_SIDED|95.0|3.3|25.9|||Mixed Models Analysis||Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||25.9|3.3|.01
74009339|NCT01495858|147569523|SUPERIORITY_OR_OTHER|||||||0.3047|||||||ANCOVA|||||||0.3047
74009340|NCT01495858|147569524|SUPERIORITY_OR_OTHER|||||||0.1677|||||||Log Rank|||||||0.1677
74009341|NCT01495858|147569525|SUPERIORITY_OR_OTHER|||||||0.2764|||||||ANCOVA|||||||0.2764
74009342|NCT01495858|147569526|SUPERIORITY_OR_OTHER|||||||0.2764|||||||ANCOVA|||||||0.2764
74040080|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|0.93||||0.5932|TWO_SIDED|95.0|0.73|1.2|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.20|0.73|0.5932
73878981|NCT01782898|147297338|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.82
74009343|NCT01495858|147569527|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74092342|NCT02504671|147737904|OTHER||Difference|62.2|||||TWO_SIDED|95.0|45.9|78.4|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||78.4|45.9|
73878982|NCT01782898|147297339|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.05
73878983|NCT01782898|147297340|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.14
74009344|NCT01495858|147569528|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
74009345|NCT01495858|147569529|SUPERIORITY_OR_OTHER|||||||0.0145|||||||Cochran-Mantel-Haenszel|||||||0.0145
74009346|NCT01495858|147569530|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
74009347|NCT01495858|147569531|SUPERIORITY_OR_OTHER|||||||0.0387|||||||Cochran-Mantel-Haenszel|||||||0.0387
74009348|NCT01495858|147569532|SUPERIORITY_OR_OTHER|||||||0.0305|||||||Cochran-Mantel-Haenszel|||||||0.0305
74009349|NCT01495858|147569533|SUPERIORITY_OR_OTHER|||||||0.0176|||||||Cochran-Mantel-Haenszel|||||||0.0176
74009350|NCT01495858|147569534|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74009351|NCT01495858|147569535|SUPERIORITY_OR_OTHER|||||||0.0036|||||||Cochran-Mantel-Haenszel|||||||0.0036
74009352|NCT01495858|147569536|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74009353|NCT01495858|147569537|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
74009354|NCT01495858|147569538|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
74009355|NCT01495858|147569539|SUPERIORITY_OR_OTHER|||||||0.4519|||||||ANCOVA|||||||0.4519
74009356|NCT01495858|147569540|SUPERIORITY_OR_OTHER|||||||0.3707|||||||ANCOVA|||||||0.3707
74009357|NCT01495858|147569541|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Log Rank|||||||>0.05
74009358|NCT01495858|147569543|SUPERIORITY_OR_OTHER|||||||0.3765|||||||Cochran-Mantel-Haenszel|||||||0.3765
74009359|NCT01576172|147569549|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
74009360|NCT01576172|147569550|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|t=-0.39 on 112.7 degrees of freedom (Satterthwaite)||||||0.70
74009361|NCT01576172|147569551|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
74040081|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3326|TWO_SIDED|95.0|0.88|1.46|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.46|0.88|0.3326
73878984|NCT03096834|147297353|SUPERIORITY||Odds Ratio (OR)|2.73||||0.002|TWO_SIDED|95.0|1.43|5.19|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (4-7 vs. 8-14) migraine days at Baseline after missing data are imputed as non-response (NRI).||||5.19|1.43|0.002
74040082|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|0.84||||0.1765|TWO_SIDED|95.0|0.65|1.08|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.08|0.65|0.1765
74040083|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5619|TWO_SIDED|95.0|0.84|1.39|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.39|0.84|0.5619
74040084|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3909|TWO_SIDED|95.0|0.69|1.16|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.16|0.69|0.3909
74040085|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7562|TWO_SIDED|95.0|0.8|1.35|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7562
74040086|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9476|TWO_SIDED|95.0|0.78|1.31|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.31|0.78|0.9476
74040087|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7746|TWO_SIDED|95.0|0.79|1.36|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.36|0.79|0.7746
74040088|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|0.94||||0.6377|TWO_SIDED|95.0|0.71|1.23|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.23|0.71|0.6377
74040089|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8532|TWO_SIDED|95.0|0.79|1.33|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.33|0.79|0.8532
74040090|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5644|TWO_SIDED|95.0|0.83|1.4|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.40|0.83|0.5644
74040091|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.04||||0.769|TWO_SIDED|0.769|0.8|1.35|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7690
74040092|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4321|TWO_SIDED|95.0|0.85|1.44|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.44|0.85|0.4321
74040093|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7714|TWO_SIDED|95.0|0.8|1.35|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7714
74040094|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8389|TWO_SIDED|95.0|0.79|1.34|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.34|0.79|0.8389
74040095|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9383|TWO_SIDED|95.0|0.76|1.29|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.29|0.76|0.9383
74040096|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|1.02||||0.88|TWO_SIDED|95.0|0.78|1.33|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.33|0.78|0.8800
74040097|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7946|TWO_SIDED|95.0|0.74|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.26|0.74|0.7946
74040098|NCT02528253|147632475|SUPERIORITY||Odds Ratio (OR)|0.96||||0.7803|TWO_SIDED|95.0|0.74|1.25|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.25|0.74|0.7803
74040099|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|1.16|STANDARD_ERROR_OF_MEAN|0.11||0.1272|TWO_SIDED|95.0|0.96|1.41|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.41|0.96|0.1272
74040100|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.1||0.6322|TWO_SIDED|95.0|0.86|1.27|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.27|0.86|0.6322
74040101|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|1.1|STANDARD_ERROR_OF_MEAN|0.12||0.3559|TWO_SIDED|95.0|0.89|1.36|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.36|0.89|0.3559
74040102|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|0.96||||0.6798|TWO_SIDED|95.0|0.77|1.18|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.18|0.77|0.6798
74040103|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|1.14||||0.267|TWO_SIDED|95.0|0.9|1.44|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.44|0.90|0.2670
74040104|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|0.94||||0.5865|TWO_SIDED|95.0|0.74|1.19|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.19|0.74|0.5865
74040105|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|1.13||||0.3378|TWO_SIDED|95.0|0.88|1.47|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.47|0.88|0.3378
74040106|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|0.92||||0.551|TWO_SIDED|95.0|0.71|1.2|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.71|0.5510
74092343|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092344|NCT02504671|147737904|OTHER||Difference|48.6|||||TWO_SIDED|95.0|31.7|65.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.6|31.7|
74092345|NCT02504671|147737904|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092346|NCT02504671|147737904|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
74092347|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092348|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092349|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092350|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 1, ACR50. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092351|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
74092352|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
74092353|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-3.1|24.7|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|
74092354|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092355|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092356|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092357|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
74092358|NCT02504671|147737905|OTHER||Difference|27.0|||||TWO_SIDED|95.0|9.3|44.7|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.7|9.3|
74092359|NCT02504671|147737905|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.9|41.8|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.8|6.9|
74092360|NCT02504671|147737905|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
74092361|NCT02504671|147737905|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
74092362|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
74092363|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 4, ACR70. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092364|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.9|-9.3|
74092365|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-11.7|27.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||27.9|-11.7|
74092366|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.9|-9.3|
74092367|NCT02504671|147737905|OTHER||Difference|-5.4|||||TWO_SIDED|95.0|-17.8|7.0|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.0|-17.8|
74092368|NCT02504671|147737905|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-16.0|10.6|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.6|-16.0|
74092369|NCT02504671|147737905|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-14.1|
74092370|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092371|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092372|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-10.1|26.3|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.3|-10.1|
74009362|NCT01576172|147569552|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
74009363|NCT01576172|147569553|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
74009364|NCT00303979|147569567|SUPERIORITY_OR_OTHER||Relative Improvement (%)|8.4|||<|0.001|TWO_SIDED|95.0|7.0|9.7|||a large sample test (z-test)|||Performance Measure #1: relative change in % of eligible patients treated with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEU/ARB).||9.7|7.0|<0.001
74009365|NCT00303979|147569567|SUPERIORITY_OR_OTHER||Relative improvement (%)|8.6|||<|0.001|TWO_SIDED|95.0|7.7|9.6|||a large sample test (z-test)|||Performance Measure #2: relative change in % of eligible patients treated with beta-blockers.||9.6|7.7|<0.001
74040107|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.18||0.2088|TWO_SIDED|95.0|0.9|1.6|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.90|0.2088
74040108|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8692|TWO_SIDED|95.0|0.73|1.3|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.30|0.73|0.8692
74040109|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|1.03|STANDARD_ERROR_OF_MEAN|0.14||0.8444|TWO_SIDED|95.0|0.78|1.35|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.35|0.78|0.8444
74040110|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.14||0.8936|TWO_SIDED|95.0|0.78|1.34|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.34|0.78|0.8936
74040111|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8716|TWO_SIDED|95.0|0.75|1.28|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.28|0.75|0.8716
74040112|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8827|TWO_SIDED|95.0|0.75|1.29|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.29|0.75|0.8827
74040113|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.14||0.8996|TWO_SIDED|95.0|0.77|1.34|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.34|0.77|0.8996
74009366|NCT00303979|147569567|SUPERIORITY_OR_OTHER||Relative improvement (%)|79.7|||<|0.001|TWO_SIDED|95.0|70.5|89.0|||a large sample test (z-test)|||Performance Measure #3: relative change in % of eligible patients treated with aldosterone receptor antagonists.||89.0|70.5|<0.001
74009367|NCT00303979|147569567|SUPERIORITY_OR_OTHER||Relative Improvement (%)|1.0||||0.546|TWO_SIDED|95.0|-2.2|4.2|||a large sample test (z-test)|||Performance Measure #4: relative change in % of eligible patients treated with anticoagulation for AF.||4.2|-2.2|0.546
74009368|NCT00303979|147569567|SUPERIORITY_OR_OTHER||Relative Improvement (%)|81.9|||<|0.001|TWO_SIDED|95.0|72.2|91.7|||a large sample test (z-test)|||Performance Measure #5: relative change in % of eligible patients treated with cardiac resynchronization therapy (CRT-P/CRT-D).||91.7|72.2|<0.001
74040114|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.13||0.488|TWO_SIDED|95.0|0.69|1.2|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.69|0.4880
74009369|NCT00303979|147569567|SUPERIORITY_OR_OTHER||Relative Improvement (%)|62.1|||<|0.001|TWO_SIDED|95.0|59.1|65.1|||a large sample test (z-test)|||Performance Measure #6: relative change in % of eligible patients treated with implantable cardioverter-defibrillator (ICD) or CRT-D.||65.1|59.1|<0.001
74009370|NCT00303979|147569567|SUPERIORITY_OR_OTHER||Relative Improvement (%)|14.7|||<|0.001|TWO_SIDED|95.0|12.6|16.8|||a large sample test (z-test)|||Performance Measure #7: relative change in % of eligible patients with HF education.||16.8|12.6|<0.001
74009371|NCT00303979|147569569|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|19.4||||0.004|TWO_SIDED|95.0|-1.1|39.8|||t-test, 2 sided|||Performance Measure #1: Relative change at 24 months compared with baseline in ACEI/ARB for the aggregate practices.||39.8|-1.1|0.004
74009372|NCT00303979|147569569|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|7.6|||<|0.001|TWO_SIDED|95.0|5.1|10.2|||t-test, 2 sided|||Performance Measure #2: the relative change at 24 months compared with baseline in beta-blockers for the aggregate practices.||10.2|5.1|<0.001
74009373|NCT00303979|147569569|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|30.0|||<|0.001|TWO_SIDED|95.0|24.6|35.5|||t-test, 2 sided|||Performance Measure #3: the relative change at 24 months compared with baseline in aldosterone antagonist for the aggregate practices.||35.5|24.6|<0.001
74040115|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.14||0.7938|TWO_SIDED|95.0|0.73|1.27|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.27|0.73|0.7938
74009374|NCT00303979|147569569|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|1.0||||0.513||95.0|-3.6|5.5|||t-test, 2 sided|||Performance Measure #4: the relative change at 24 months compared with baseline in anticoagulation for AF for the aggregate practices.||5.5|-3.6|0.513
74009375|NCT00303979|147569569|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|48.4|||<|0.001|TWO_SIDED|95.0|37.9|58.8|||t-test, 2 sided|||Performance Measure #5: the relative change at 24 months compared with baseline in CRT-P/CRT-D for the aggregate practices.||58.8|37.9|<0.001
74009376|NCT00303979|147569569|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|70.9|||<|0.001|TWO_SIDED|95.0|61.0|80.8|||t-test, 2 sided|||Performance Measure #6: the relative change at 24 months compared with baseline in ICD/CRT-D for the aggregate practices.||80.8|61.0|<0.001
74009377|NCT00303979|147569569|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|50.6|||<|0.001|TWO_SIDED|95.0|27.1|74.2|||t-test, 2 sided|||Performance Measure #7: the relative change at 24 months compared with baseline in HF education for the aggregate practices.||74.2|27.1|<0.001
74009378|NCT00303979|147569569|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|19.2|||<|0.001|TWO_SIDED|95.0|16.3|22.0|||t-test, 2 sided|||Composite Score: The relative change at 24 months compared with baseline in composite score for the aggregate practices.||22.0|16.3|<0.001
74009379|NCT00303979|147569570|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.3||||0.197|TWO_SIDED|95.0|-5.4|25.9|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.||25.9|-5.4|0.197
74009380|NCT00303979|147569570|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.6||||0.061|TWO_SIDED|95.0|-0.5|21.7|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort B (6 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.||21.7|-0.5|0.061
74040116|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.13||0.5092|TWO_SIDED|95.0|0.69|1.2|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.69|0.5092
74092373|NCT02504671|147737905|OTHER||Difference|24.3|||||TWO_SIDED|95.0|4.5|44.1|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.1|4.5|
74009381|NCT00303979|147569570|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|-1.1||||0.622|TWO_SIDED|95.0|-5.7|3.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort B (6 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.||3.4|-5.7|0.622
74009382|NCT00303979|147569570|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.2||||0.05|TWO_SIDED|95.0|0.0|12.4|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort B (6 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.||12.4|0.0|0.05
74009383|NCT00303979|147569570|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|-1.8||||0.711|TWO_SIDED|95.0|-11.2|7.7|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort B (6 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.||7.7|-11.2|0.711
74009384|NCT00303979|147569570|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|14.4|||<|0.001|TWO_SIDED|95.0|6.9|22.0|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.||22.0|6.9|<0.001
74009385|NCT00303979|147569570|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|38.5|||<|0.001|TWO_SIDED|95.0|23.2|53.8|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort B (6 months) compared with Cohort A at baseline in HF education for the aggregate practices.||53.8|23.2|<0.001
74009386|NCT00303979|147569570|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.6|||<|0.001|TWO_SIDED|95.0|4.2|9.0|||t-test, 2 sided|||Composite Score: the relative change of Cohort B (6 months) compared with Cohort A at baseline in composite score for the aggregate practices.||9.0|4.2|<0.001
74009387|NCT00303979|147569571|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.5||||0.19|TWO_SIDED|95.0|-5.3|26.3|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.||26.3|-5.3|0.190
74009388|NCT00303979|147569571|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|14.3||||0.048|TWO_SIDED|95.0|0.1|28.4|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort C (18 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.||28.4|0.1|0.048
74009389|NCT00303979|147569571|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|5.8||||0.24|TWO_SIDED|95.0|-3.9|15.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort C (18 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.||15.4|-3.9|0.240
74009390|NCT00303979|147569571|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.7||||0.033|TWO_SIDED|95.0|0.5|13.0|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort C (18 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.||13.0|0.5|0.033
74009391|NCT00303979|147569571|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|9.3||||0.085|TWO_SIDED|95.0|-1.3|19.8|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort C (18 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.||19.8|-1.3|0.085
74040117|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.13||0.6148|TWO_SIDED|95.0|0.71|1.22|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.22|0.71|0.6148
74040118|NCT02528253|147632477|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.12||0.2844|TWO_SIDED|95.0|0.66|1.13|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.13|0.66|0.2844
74092374|NCT02504671|147737905|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
74092375|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
74009392|NCT00303979|147569571|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|17.6|||<|0.001|TWO_SIDED|95.0|9.3|25.8|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.||25.8|9.3|<0.001
73878985|NCT03096834|147297354|SUPERIORITY||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|0.55||0.004|TWO_SIDED|95.0|-2.67|-0.51|||Mixed Models Analysis|||Month 3||-0.51|-2.67|0.004
73878986|NCT03096834|147297355|SUPERIORITY||Mean Difference (Final Values)|-3.46|STANDARD_ERROR_OF_MEAN|1.13||0.003|TWO_SIDED|95.0|-5.7|-1.23|||Mixed Models Analysis|||Physical impairment domain||-1.23|-5.70|0.003
74009393|NCT00303979|147569571|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|59.5|||<|0.001|TWO_SIDED|95.0|33.9|85.2|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort C (18 months) compared with Cohort A at baseline in HF education for the aggregate practices.||85.2|33.9|<0.001
74009394|NCT00303979|147569571|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.6|||<|0.001|TWO_SIDED|95.0|7.6|13.6|||t-test, 2 sided|||Composite Score: the relative change of Cohort C (18 months) compared with Cohort A at baseline in composite score for the aggregate practices.||13.6|7.6|<0.001
74092376|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74040119|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.1|STANDARD_ERROR_OF_MEAN|0.25||0.6764|TWO_SIDED|95.0|0.7|1.73|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.73|0.70|0.6764
74040120|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.23||0.9351|TWO_SIDED|95.0|0.65|1.6|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.65|0.9351
74040121|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.2||0.8731|TWO_SIDED|95.0|0.64|1.46|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.64|0.8731
74040122|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.14|STANDARD_ERROR_OF_MEAN|0.24||0.537|TWO_SIDED|95.0|0.75|1.72|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.72|0.75|0.5370
74040123|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.22||0.8031|TWO_SIDED|95.0|0.7|1.59|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.59|0.70|0.8031
74040124|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.24||0.8192|TWO_SIDED|95.0|0.57|1.55|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.55|0.57|0.8192
74040125|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.22||0.6345|TWO_SIDED|95.0|0.54|1.46|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.54|0.6345
74040126|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.21||0.6103|TWO_SIDED|95.0|0.56|1.4|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.40|0.56|0.6103
74040127|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.25||0.7949|TWO_SIDED|95.0|0.67|1.67|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.67|0.67|0.7949
74040128|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.23||0.992|TWO_SIDED|95.0|0.63|1.57|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.57|0.63|0.9920
74040129|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.27||0.8772|TWO_SIDED|95.0|0.55|1.67|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.67|0.55|0.8772
74092377|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
73878987|NCT03096834|147297355|SUPERIORITY||Mean Difference (Final Values)|-3.91|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.12|-1.7|||Mixed Models Analysis|||Everyday activities domain||-1.70|-6.12|<0.001
73878988|NCT03096834|147297356|SUPERIORITY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.43|-0.99|||Mixed Models Analysis|||||-0.99|-2.43|<0.001
73878989|NCT03096834|147297357|SUPERIORITY||Odds Ratio (OR)|3.16||||0.025|TWO_SIDED|95.0|1.11|9.01|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (4-7 vs. 8-14) migraine days at Baseline after missing data are imputed as non-response||||9.01|1.11|0.025
73878990|NCT02849418|147297368|OTHER||Mean Difference (Net)|-3.02|||||TWO_SIDED|95.0|-5.85|-0.19|||||The analysis method was mixed-model for repeated measures (MMRM) with treatment, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|||-0.19|-5.85|
74040130|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.7614|TWO_SIDED|95.0|0.53|1.6|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.53|0.7614
74009395|NCT05417607|147569584|SUPERIORITY||Mean Difference (Net)|3.75|STANDARD_DEVIATION|5.86||0.0047|TWO_SIDED|95.0|1.27|6.22|||t-test, 2 sided|||Within group pre- and post-intervention.||6.22|1.27|0.0047
74040131|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.22||0.5629|TWO_SIDED|95.0|0.52|1.43|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.43|0.52|0.5629
74040132|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.29||0.6821|TWO_SIDED|95.0|0.67|1.85|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.85|0.67|0.6821
74040133|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.07|STANDARD_ERROR_OF_MEAN|0.28||0.8049|TWO_SIDED|95.0|0.64|1.77|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.77|0.64|0.8049
74092378|NCT02504671|147737905|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74009396|NCT05417607|147569585|SUPERIORITY||Mean Difference (Net)|2.21|STANDARD_DEVIATION|7.9||0.2383|TWO_SIDED|95.0|-1.6|6.02|||t-test, 2 sided|||Within group pre- and post-intervention.||6.02|-1.6|0.2383
74009397|NCT05417607|147569586|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_DEVIATION|3.58||0.3426|TWO_SIDED|95.0|-2.22|0.8|||t-test, 2 sided|||Within group pre- and post-intervention.||0.80|-2.22|0.3426
74009398|NCT02901574|147569623|SUPERIORITY||Mean Difference (Final Values)|3.87||||0.24|TWO_SIDED|95.0|-2.55|10.3||Threshold for significance is two-sided alpha of 0.05.|Mixed Models Analysis|||||10.30|-2.55|0.24
74009399|NCT02790138|147569635|SUPERIORITY||Percentage Difference|21.6||||0.013|TWO_SIDED|95.0|4.9|37.5||The significance level was 0.05.|Fisher's Exact Test|||The Placebo IV and Vedolizumab IV 300 mg groups were analyzed using Fisher's Exact Test at Week 14.||37.5|4.9|0.013
74009400|NCT02790138|147569636|SUPERIORITY||Percentage Difference|17.6|||=|0.043|TWO_SIDED|95.0|0.3|35.1||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||||35.1|0.3|=0.043
74009401|NCT02790138|147569637|SUPERIORITY||Percentage Difference|25.5|||=|0.004|TWO_SIDED|95.0|8.0|41.4||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Fisher's Exact Test|||Week 14||41.4|8.0|=0.004
74009402|NCT02790138|147569637|SUPERIORITY||Percentage Difference|19.6|||=|0.027|TWO_SIDED|95.0|1.9|37.0||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 34.||37.0|1.9|=0.027
74009403|NCT02790138|147569638|SUPERIORITY||Hazard Ratio (HR)|3.95|||||TWO_SIDED|95.0|1.7|9.4|||||Hazard ratio for achieving PDAI remission.|||9.4|1.7|
74009404|NCT02790138|147569639|SUPERIORITY||Percentage Difference|29.4|||=|0.003|TWO_SIDED|95.0|8.0|47.6||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 14||47.6|8.0|=0.003
74040134|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.27||0.6673|TWO_SIDED|95.0|0.47|1.62|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.62|0.47|0.6673
74040135|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.25||0.4475|TWO_SIDED|95.0|0.43|1.46|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.43|0.4475
74040136|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.25||0.5925|TWO_SIDED|95.0|0.49|1.5|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.50|0.49|0.5925
74092379|NCT02504671|147737905|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74009405|NCT02790138|147569639|SUPERIORITY||Percentage Difference|21.6|||=|0.026|TWO_SIDED|95.0|1.9|39.8||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 34||39.8|1.9|=0.026
74009406|NCT02790138|147569640|SUPERIORITY||Odds Estimator|2.02|||=|0.002|TWO_SIDED|95.0|1.11|2.93||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.93|1.11|=0.002
74009407|NCT02790138|147569640|SUPERIORITY||Odds Estimator|1.71|||=|0.02|TWO_SIDED|95.0|0.92|2.49||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.49|0.92|=0.020
74009408|NCT02790138|147569641|SUPERIORITY||Odds Estimator|1.34|||=|0.191|TWO_SIDED|95.0|0.74|1.94||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||1.94|0.74|=0.191
74009409|NCT02790138|147569641|SUPERIORITY||Odds Estimator|1.07|||=|0.766|TWO_SIDED|95.0|0.6|1.54||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||1.54|0.60|=0.766
74009410|NCT02790138|147569642|SUPERIORITY||Odds Estimator|1.57|||=|0.055|TWO_SIDED|95.0|0.83|2.31||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.31|0.83|=0.055
74009411|NCT02790138|147569642|SUPERIORITY||Odds Estimator|1.48|||=|0.095|TWO_SIDED|95.0|0.79|2.16||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.16|0.79|=0.095
74009412|NCT02790138|147569643|SUPERIORITY||Odds Estimator|1.14|||=|0.575|TWO_SIDED|95.0|0.61|1.67||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||1.67|0.61|=0.575
73878991|NCT00762359|147297448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.0989|||<|0.0001|TWO_SIDED|95.0|0.0425|0.23|||Log Rank|||||0.2300|0.0425|<0.0001
73878992|NCT00762359|147297449|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73878993|NCT00762359|147297450|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73878994|NCT00762359|147297451|SUPERIORITY_OR_OTHER|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
73878995|NCT00762359|147297452|SUPERIORITY_OR_OTHER|||||||0.0433||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0433
73878996|NCT00762359|147297454|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73878997|NCT00762359|147297455|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0006
73878998|NCT00762359|147297456|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0025
73878999|NCT00762359|147297457|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0010
74009413|NCT02790138|147569643|SUPERIORITY||Odds Estimator|1.21|||=|0.403|TWO_SIDED|95.0|0.65|1.78||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 22||1.78|0.65|=0.403
74009414|NCT02790138|147569643|SUPERIORITY||Odds Estimator|1.6|||=|0.047|TWO_SIDED|95.0|0.85|2.34||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.34|0.85|=0.047
74009415|NCT02790138|147569644|SUPERIORITY||Odds Estimator|1.44|||=|0.119|TWO_SIDED|95.0|0.77|2.12||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.12|0.77|=0.119
74040137|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.29||0.9486|TWO_SIDED|95.0|0.58|1.79|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.79|0.58|0.9486
74040138|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.7673|TWO_SIDED|95.0|0.52|1.61|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.61|0.52|0.7673
74040139|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.39||0.7635|TWO_SIDED|95.0|0.56|2.2|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||2.20|0.56|0.7635
74092380|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
73879000|NCT00762359|147297459|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
73879001|NCT00762359|147297460|SUPERIORITY_OR_OTHER|||||||0.6148||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6148
74009416|NCT02790138|147569644|SUPERIORITY||Odds Estimator|1.15|||=|0.542|TWO_SIDED|95.0|0.62|1.69||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 22||1.69|0.62|=0.542
74009417|NCT02790138|147569644|SUPERIORITY||Odds Estimator|1.22|||=|0.404|TWO_SIDED|95.0|0.65|1.78||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||1.78|0.65|=0.404
74040140|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.34||0.9564|TWO_SIDED|95.0|0.5|1.94|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.94|0.50|0.9564
74092381|NCT02504671|147737905|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.0|42.7|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.7|6.0|
73879002|NCT00762359|147297461|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8050
73879003|NCT00762359|147297462|SUPERIORITY_OR_OTHER|||||||0.8678||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8678
73879004|NCT00762359|147297463|SUPERIORITY_OR_OTHER|||||||0.2688||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2688
73879005|NCT00762359|147297465|SUPERIORITY_OR_OTHER|||||||0.7054||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7054
73879006|NCT00762359|147297466|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3400
73879007|NCT00762359|147297467|SUPERIORITY_OR_OTHER|||||||0.8813||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8813
73879008|NCT00762359|147297468|SUPERIORITY_OR_OTHER|||||||0.1862||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1862
73879009|NCT00762359|147297470|SUPERIORITY_OR_OTHER|||||||0.8604||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8604
73879010|NCT00762359|147297471|SUPERIORITY_OR_OTHER|||||||0.5485||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5485
73879011|NCT00762359|147297472|SUPERIORITY_OR_OTHER|||||||0.7382||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7382
73879012|NCT00762359|147297473|SUPERIORITY_OR_OTHER|||||||0.7619||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7619
73879013|NCT00762359|147297475|SUPERIORITY_OR_OTHER|||||||0.0204||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0204
73879014|NCT00762359|147297476|SUPERIORITY_OR_OTHER|||||||0.0046||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0046
73879015|NCT00762359|147297477|SUPERIORITY_OR_OTHER|||||||0.0059||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0059
73879016|NCT00762359|147297478|SUPERIORITY_OR_OTHER|||||||0.1229||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1229
73879017|NCT00762359|147297480|SUPERIORITY_OR_OTHER|||||||0.2694||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2694
74009418|NCT01226459|147569652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|95.0|5.0|13.1|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in foam group had no hair information at Baseline. Statistical analysis is of the change from baseline to week 24 data.||13.1|5.0|<0.0001
74009419|NCT01226459|147569653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8|||<|0.0001|TWO_SIDED|95.0|7.0|14.7|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is of the change from baseline to week 12 data.||14.7|7.0|<0.0001
74009420|NCT01226459|147569654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.0001|TWO_SIDED|95.0|0.35|1.04|||ANCOVA|||||1.04|0.35|<0.0001
74040141|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.3||0.8359|TWO_SIDED|95.0|0.5|1.75|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.75|0.50|0.8359
74040142|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.19|STANDARD_ERROR_OF_MEAN|0.38||0.5914|TWO_SIDED|95.0|0.64|2.21|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||2.21|0.64|0.5914
74040143|NCT02528253|147632479|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.33||0.8826|TWO_SIDED|95.0|0.56|1.95|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.95|0.56|0.8826
74040144|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|7.02|STANDARD_ERROR_OF_MEAN|2.01||0.0005|TWO_SIDED|95.0|3.07|10.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||10.97|3.07|0.0005
74092382|NCT02504671|147737905|OTHER||Difference|29.7|||||TWO_SIDED|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.4|11.0|
73879018|NCT00762359|147297481|SUPERIORITY_OR_OTHER|||||||0.0141||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0141
73879019|NCT00762359|147297482|SUPERIORITY_OR_OTHER|||||||0.3128||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3128
74009421|NCT03770091|147569657|SUPERIORITY|ANOVA performed||||||0.6|||||||ANOVA|||||||0.6
74009422|NCT03770091|147569658|SUPERIORITY|||||||0.59|||||||ANOVA|||||||0.59
74009423|NCT03770091|147569659|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
74040145|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|6.21|STANDARD_ERROR_OF_MEAN|2.01||0.0021|TWO_SIDED|95.0|2.26|10.15|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||10.15|2.26|0.0021
74040146|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|4.72|STANDARD_ERROR_OF_MEAN|1.89||0.0125|TWO_SIDED|95.0|1.02|8.42|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.42|1.02|0.0125
74040147|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.87||0.2176|TWO_SIDED|95.0|-1.36|5.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.97|-1.36|0.2176
74040148|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|1.86||0.4235|TWO_SIDED|95.0|-2.16|5.14|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.14|-2.16|0.4235
74040149|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|4.96||0.0143|TWO_SIDED|95.0|2.5|22.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||22.11|2.50|0.0143
74040150|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|12.55|STANDARD_ERROR_OF_MEAN|4.96||0.0124|TWO_SIDED|95.0|2.76|22.35|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||22.35|2.76|0.0124
74040151|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|3.88|STANDARD_ERROR_OF_MEAN|4.29||0.3675|TWO_SIDED|95.0|-4.6|12.36|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||12.36|-4.60|0.3675
74040152|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|8.42|STANDARD_ERROR_OF_MEAN|3.89||0.0319|TWO_SIDED|95.0|0.74|16.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.11|0.74|0.0319
74040153|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|8.67|STANDARD_ERROR_OF_MEAN|3.9||0.0276|TWO_SIDED|95.0|0.97|16.38|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.38|0.97|0.0276
74040154|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|2.57|STANDARD_ERROR_OF_MEAN|1.38||0.0627|TWO_SIDED|95.0|-0.14|5.27|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.27|-0.14|0.0627
74092383|NCT02504671|147737905|OTHER||Difference|40.5|||||TWO_SIDED|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||59.5|21.6|
74009424|NCT03770091|147569660|SUPERIORITY|||||||0.45|||||||ANCOVA|||||||0.45
74009425|NCT03770091|147569661|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
74009426|NCT01092143|147569696|SUPERIORITY||Adjusted mean treatment differences|3.083|STANDARD_DEVIATION|1.65||0.0311|TWO_SIDED|95.0|-0.157|6.323||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 50 mg b.i.d. compared with those treated with placebo, after 6 weeks.||6.323|-0.157|0.0311
74092384|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-10.6|16.0|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.0|-10.6|
74092385|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
74092386|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
74092387|NCT02504671|147737905|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
74092388|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
74092389|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
74092390|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-5.4|32.4|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.4|-5.4|
74092391|NCT02504671|147737905|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
74092392|NCT02504671|147737905|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
74092393|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
74092394|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
74092395|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
74092396|NCT02504671|147737905|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
74092397|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
74092398|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
74092399|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-10.1|26.3|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.3|-10.1|
74092400|NCT02504671|147737905|OTHER||Difference|21.6|||||TWO_SIDED|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|
74092401|NCT02504671|147737905|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.9|57.8|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.8|17.9|
74092402|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-10.6|16.0|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.0|-10.6|
74092403|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
74092404|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
74092405|NCT02504671|147737905|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
74092406|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-3.1|24.7|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|
74092407|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
74092408|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-6.9|28.5|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.5|-6.9|
74092409|NCT02504671|147737905|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.3|7.7|
74092410|NCT02504671|147737905|OTHER||Difference|43.2|||||TWO_SIDED|95.0|23.8|62.6|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||62.6|23.8|
74092411|NCT02504671|147737905|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-14.1|
74092412|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.7|-1.2|
74092413|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|1.1|36.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.7|1.1|
74092414|NCT02504671|147737905|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
74092415|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
74092416|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
74092417|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092418|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092419|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092420|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092421|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092422|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092423|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092424|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092425|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092426|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092427|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
74092428|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
74092429|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092430|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
74092431|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092432|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092433|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092434|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092435|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092436|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092437|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092438|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092439|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092440|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
74092441|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092442|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
74092443|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092444|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092445|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092446|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
74092447|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092448|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
73879020|NCT00762359|147297483|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1450
73879021|NCT00762359|147297485|SUPERIORITY_OR_OTHER|||||||0.6175||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6175
74092449|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092450|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092451|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092452|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092453|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092454|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092455|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092456|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092457|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092458|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092459|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092460|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
74092461|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092462|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092463|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092464|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092465|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092466|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
73879022|NCT00762359|147297486|SUPERIORITY_OR_OTHER|||||||0.4496||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4496
74092467|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
73879023|NCT00762359|147297487|SUPERIORITY_OR_OTHER|||||||0.4718||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4718
73879024|NCT00762359|147297488|SUPERIORITY_OR_OTHER|||||||0.4484||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4484
73879025|NCT00762359|147297490|SUPERIORITY_OR_OTHER|||||||0.2604||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2604
73879026|NCT00762359|147297491|SUPERIORITY_OR_OTHER|||||||0.6818||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6818
73879027|NCT00762359|147297492|SUPERIORITY_OR_OTHER|||||||0.9015||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9015
73879028|NCT00762359|147297493|SUPERIORITY_OR_OTHER|||||||0.4497||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4497
73879029|NCT05482308|147297534|OTHER||Mean differences(Test-Reference)|98.35|||||TWO_SIDED|90.0|92.92|104.1|||Mixed effect model|"Mixed effect model was fitted to obtain:~1.Adjusted mean differences 2.90% Confidence intervals(CI)"||||104.10|92.92|
73879030|NCT05482308|147297535|OTHER||Mean difference (Test-Reference)|91.58|||||TWO_SIDED|90.0|81.5|102.9|||Mixed effect model|"Mixed effect model was fitted to obtain:~1.Adjusted mean differences 2.90% Confidence intervals(CI)"||||102.90|81.50|
73879031|NCT04245111|147297573|OTHER|No other statistical analysis completed other than percentage of patients completed as reported in the data table section||||||||||||||||No other statistical analysis completed other than percentage of patients completed as reported in the data table section|No other statistical analysis completed other than percentage of patients completed as reported in the data table section|||
74009427|NCT01092143|147569696|SUPERIORITY||Adjusted mean treatment differences|3.589|STANDARD_DEVIATION|1.6||0.0126|TWO_SIDED|95.0|0.447|6.732||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, trea||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with placebo, after 6 weeks.||6.732|0.447|0.0126
74009428|NCT01092143|147569696|SUPERIORITY||Adjusted mean treatment differences|3.977|STANDARD_DEVIATION|1.64||0.0078|TWO_SIDED|95.0|0.756|7.197||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with placebo, after 6 weeks.||7.197|0.756|0.0078
74009429|NCT01092143|147569696|OTHER||Adjusted mean treatment differences|8.619|STANDARD_DEVIATION|1.684|<|0.0001|TWO_SIDED|95.0|5.312|11.927||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with fluticasone propionate 110 mcg 2 puffs b.i.d. compared with those treated with placebo, after 6 weeks.||11.927|5.312|<.0001
74092468|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092469|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
73879032|NCT03192176|147297605|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.84||0.024|TWO_SIDED|95.0|-3.56|-0.25||LS Means(LSM), standard errors(SE), confidence intervals(CI), \& p-values come from an ANCOVA model with CFB as the dependent variable \& treatment group, pooled center, smoking status as factors \& baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.25|-3.56|0.0240
73879033|NCT03192176|147297605|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0004|TWO_SIDED|95.0|-4.68|-1.38||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.38|-4.68|0.0004
73879034|NCT03192176|147297605|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.001|TWO_SIDED|95.0|-4.44|-1.14||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.14|-4.44|0.0010
73879035|NCT03192176|147297605|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED|95.0|-5.2|-1.89||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.89|-5.20|<0.0001
73879036|NCT03192176|147297605|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.84||0.0058||95.0|-4.0|-0.68||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.68|-4.00|0.0058
73879037|NCT03192176|147297605|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|-4.65|-1.41||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.41|-4.65|0.0003
73879038|NCT03192176|147297605|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.84||0.0042|TWO_SIDED|95.0|-4.06|0.76||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.76|-4.06|0.0042
73887949|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7|||<|0.0001|TWO_SIDED|95.0|12.0|27.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.4|12.0|<0.0001
73879039|NCT03192176|147297606|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.0154|TWO_SIDED|95.0|-3.3|-0.35||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.35|-3.30|0.0154
73879040|NCT03192176|147297606|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.74||0.0043|TWO_SIDED|95.0|-3.6|-0.67||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.67|-3.60|0.0043
74009430|NCT01092143|147569696|SUPERIORITY||Adjusted mean treatment differences|-5.536|STANDARD_DEVIATION|1.653||0.9996|TWO_SIDED|95.0|-8.783|-2.29||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 50 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks.||-2.290|-8.783|0.9996
74009431|NCT01092143|147569696|SUPERIORITY||Adjusted mean treatment differences|-5.03|STANDARD_DEVIATION|1.606||0.9991|TWO_SIDED|95.0|-8.185|-1.875||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with fluticasone propionate 220mcg b.i.d., after 6 weeks.||-1.875|-8.185|0.9991
74040155|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|3.26|STANDARD_ERROR_OF_MEAN|1.38||0.0187|TWO_SIDED|95.0|0.54|5.97|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.97|0.54|0.0187
74040156|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|1.52|STANDARD_ERROR_OF_MEAN|1.3||0.2419|TWO_SIDED|95.0|-1.03|4.06|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.06|-1.03|0.2419
74040157|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.28||0.4124|TWO_SIDED|95.0|-1.46|3.56|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||3.56|-1.46|0.4124
74040158|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|1.27||0.173|TWO_SIDED|95.0|-0.76|4.24|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.24|-0.76|0.1730
74040159|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|5.42|STANDARD_ERROR_OF_MEAN|1.86||0.0037|TWO_SIDED|95.0|1.77|9.08|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||9.08|1.77|0.0037
74040160|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|3.74|STANDARD_ERROR_OF_MEAN|1.86||0.0449|TWO_SIDED|95.0|0.09|7.39|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||7.39|0.09|0.0449
74040161|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|1.75||0.2038|TWO_SIDED|95.0|-1.21|5.65|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.65|-1.21|0.2038
74040162|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|1.73||0.0644|TWO_SIDED|95.0|-0.19|6.59|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.59|-0.19|0.0644
74040163|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|1.52|STANDARD_ERROR_OF_MEAN|1.72||0.3775|TWO_SIDED|95.0|-1.86|4.9|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.90|-1.86|0.3775
74040164|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|1.45|STANDARD_ERROR_OF_MEAN|2.62||0.5806|TWO_SIDED|95.0|-3.7|6.6|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.60|-3.70|0.5806
74040165|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.53||0.6084|TWO_SIDED|95.0|-3.68|6.27|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.27|-3.68|0.6084
74040166|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|2.71|STANDARD_ERROR_OF_MEAN|6.95||0.6991|TWO_SIDED|95.0|-11.56|16.99|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.99|-11.56|0.6991
74040167|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|13.17|STANDARD_ERROR_OF_MEAN|5.6||0.0265|TWO_SIDED|95.0|1.66|24.68|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||24.68|1.66|0.0265
74040168|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.99||0.8795|TWO_SIDED|95.0|-3.61|4.21|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.21|-3.61|0.8795
73879041|NCT03192176|147297606|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.75||0.0023|TWO_SIDED|95.0|-3.76|-0.83||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.83|-3.76|0.0023
74040169|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.92||0.2758|TWO_SIDED|95.0|-1.68|5.87|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.87|-1.68|0.2758
74040170|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|3.54|STANDARD_ERROR_OF_MEAN|2.27||0.1197|TWO_SIDED|95.0|-0.92|8.0|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.00|-0.92|0.1197
74040171|NCT02528253|147632488|SUPERIORITY||LS Mean Difference|3.93|STANDARD_ERROR_OF_MEAN|2.19||0.0743|TWO_SIDED|95.0|-0.39|8.24|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.24|-0.39|0.0743
74040172|NCT00873288|147632517|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||t-test, 2 sided|||||||> 0.05
74040173|NCT00873288|147632519|SUPERIORITY|||||||0.207|||||||Chi-squared|The Pearson Chi-squared value = 1.590||||||0.207
74040174|NCT00873288|147632520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||t-test, 2 sided|||||||0.66
74040175|NCT04131933|147632554|SUPERIORITY|It was hypothesized that there would be a 50% reduction in Oncotype DX assay requests following the intervention.||||||0.37|||||||Fisher Exact|Fisher's exact test to compare number of patients with Oncotype DX ordered at 0-6 months (pre-intervention) vs 7-12 months (post-intervention)||Pre-Intervention (Period 1 and Period 2) vs Post-Intervention (Period 3 and Period 4)||||0.37
74040176|NCT02034552|147632570|SUPERIORITY|||||||0.0109||||||\[80% CI\]: \[10.1%- 39.6%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||0.0109
74040177|NCT02034552|147632570|SUPERIORITY||||||<|0.0001||||||\[80% CI\]: \[40.8% - 73.7%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||<0.0001
74040178|NCT02034552|147632570|SUPERIORITY||||||<|0.0001||||||\[80% CI\]: \[31.8% - 68.2%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||<0.0001
74040179|NCT03807245|147632584|OTHER||||||<|0.0001|||||||ANOVA|||Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 25mcg/placebo||||<0.0001
74092470|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
73887950|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|104.7|||<|0.0001|TWO_SIDED|95.0|87.7|121.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||121.8|87.7|<0.0001
74040180|NCT03807245|147632584|OTHER||||||<|0.0001|||||||ANOVA|||Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 50mcg/placebo||||<0.0001
74092471|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092472|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092473|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74040181|NCT00291499|147632587|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.016
74040182|NCT00291499|147632588|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
74040183|NCT00291499|147632589|SUPERIORITY|||||||0.043||||||Threshold p \<0.05|Cochran-Mantel-Haenszel|||||||0.043
74040184|NCT00291499|147632590|SUPERIORITY|||||||0.132||||||Threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.132
74040185|NCT00291499|147632591|SUPERIORITY|||||||0.031||||||Threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.031
74040186|NCT00291499|147632592|SUPERIORITY||Mean Difference (Final Values)|0.363|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74040187|NCT01082367|147632619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.55|||<|0.001|TWO_SIDED|95.0|4.67|99.52|||Regression, Logistic|||||99.52|4.67|<0.001
74040188|NCT04190186|147632626|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.594|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.594
74040189|NCT02016898|147632637|OTHER||Risk Ratio (RR)|0.93||||0.7|TWO_SIDED|95.0|0.67|1.29|||Chi-squared|||||1.29|0.67|0.7
74040190|NCT02016898|147632638|OTHER||Median Difference (Final Values)|0.2|STANDARD_DEVIATION|2.01||0.539|TWO_SIDED||||||t-test, 1 sided|||||||0.539
74040191|NCT00618995|147632643|NON_INFERIORITY_OR_EQUIVALENCE|Two treatments are comparable if the geometric mean ratio (GMR) is contained within the interval \[0.50-2.00\].|Geometric least-squares mean ratio|0.97||||||90.0|0.8|1.18||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) \[Treatment A/B\] of the urine levels of 11-dTxB2 on Day 7.||1.18|0.8|
74040192|NCT00618995|147632643|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.77|1.14||||||||1.14|0.77|
74040193|NCT00618995|147632643|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.05||||||||1.05|0.71|
73879042|NCT03192176|147297606|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.75||0.0005|TWO_SIDED|95.0|-4.09|-1.16||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.16|-4.09|0.0005
73879043|NCT03192176|147297606|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0064|TWO_SIDED|95.0|-3.52|-0.58||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.58|-3.52|0.0064
74009432|NCT01092143|147569696|SUPERIORITY||Adjusted mean treatment differences|-4.643|STANDARD_DEVIATION|1.647||0.9975|TWO_SIDED|95.0|-7.877|-1.408||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks.||-1.408|-7.877|0.9975
74009433|NCT01092143|147569697|SUPERIORITY||Adjusted mean treatment differences|0.073|STANDARD_DEVIATION|0.113||0.7413|TWO_SIDED|95.0|-0.149|0.295||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.295|-0.149|0.7413
74040194|NCT00618995|147632643|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.84||||||90.0|0.69|1.02||||||||1.02|0.69|
74040195|NCT00618995|147632643|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.92||||||90.0|0.76|1.13||||||||1.13|0.76|
74040196|NCT00618995|147632643|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.9||||||90.0|0.74|1.09||||||||1.09|0.74|
74040197|NCT00618995|147632644|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.06||||||||1.06|0.84|
74040198|NCT00618995|147632644|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.05||||||||1.05|0.84|
74040199|NCT00618995|147632644|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64||||||||0.64|0.51|
74040200|NCT00618995|147632644|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.54||||||90.0|0.48|0.6||||||||0.60|0.48|
74040201|NCT00618995|147632644|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.6||||||90.0|0.54|0.67||||||||0.67|0.54|
74040202|NCT00618995|147632644|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64||||||||0.64|0.51|
74040203|NCT02988219|147632651|SUPERIORITY_OR_OTHER|||||||0.3861|||||||Chi-squared|||Bradycardia during surgery||||0.3861
74040204|NCT02988219|147632651|SUPERIORITY_OR_OTHER|||||||0.2591|||||||Chi-squared|||No bradycardia observed in the perioperative period||||0.2591
74040205|NCT02988219|147632652|SUPERIORITY_OR_OTHER|||||||0.597|||||||Chi-squared|||Arrhythmia before surgery||||0.597
74040206|NCT02988219|147632652|SUPERIORITY_OR_OTHER|||||||0.4|||||||Chi-squared|||arrhythmia during surgery||||0.4
74040207|NCT02988219|147632652|SUPERIORITY_OR_OTHER|||||||0.6544|||||||Chi-squared|||arrhythmia after surgery||||0.6544
74040208|NCT02988219|147632652|SUPERIORITY_OR_OTHER|||||||0.077|||||||Chi-squared|||long QTc \> 0.45s after surgery||||0.077
74040209|NCT02988219|147632652|SUPERIORITY_OR_OTHER|||||||0.0174|||||||Chi-squared|||long QTc \> 0.24 s in the perioperative time||||0.0174
74040210|NCT02855450|147632681|SUPERIORITY||Least square means difference|4.7||||0.04|TWO_SIDED|95.0|0.2|9.2|||ANCOVA|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.||These statistics refer to Day 7 and primary eye||9.2|0.2|0.040
74040211|NCT02855450|147632681|SUPERIORITY||least square mean difference|2.4||||0.457|TWO_SIDED|95.0|-4.1|9.0||Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|ANCOVA|||These statistics refer to Day 28 and primary eye||9.0|-4.1|0.457
74040212|NCT02855450|147632681|SUPERIORITY||least square mean difference|4.0||||0.283|TWO_SIDED|95.0|-3.5|11.5||Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|ANCOVA|||These statistics refer to Day 56 and primary eye||11.5|-3.5|0.283
74040213|NCT02855450|147632681|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|Least square means difference|3.5||||0.147|TWO_SIDED|95.0|-1.3|8.3|||ANCOVA|||These statistics refer to Day 7 and secondary eye||8.3|-1.3|0.147
74040214|NCT02855450|147632681|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|least square mean difference|3.0||||0.421|TWO_SIDED|95.0|-4.4|10.4|||ANCOVA|||These statistics refer to Day 28 and secondary eye||10.4|-4.4|0.421
74040215|NCT02855450|147632681|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|least square mean difference|4.3||||0.327|TWO_SIDED|95.0|-4.4|13.0|||ANCOVA|||These statistics refer to Day 56 and secondary eye||13.0|-4.4|0.327
74040216|NCT05053126|147632687|SUPERIORITY||Mean Difference (Final Values)|36.83|STANDARD_ERROR_OF_MEAN|3.132|<|0.0001|ONE_SIDED|95.0|31.65||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 =15"|||31.65|<0.0001
74040217|NCT05053126|147632687|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|3.49||0.2469|ONE_SIDED|95.0||3.4|||Mixed Models Analysis|||"The primary analysis evaluated whether pregabalin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||3.4||0.2469
74092474|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092475|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092476|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74040218|NCT05053126|147632687|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|3.48||0.1756|ONE_SIDED|95.0||2.5|||Mixed Models Analysis|||"The primary analysis evaluated whether pregabalin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||2.5||0.1756
74040219|NCT05053126|147632687|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.84||0.0001|ONE_SIDED|95.0||4.3|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μL ≤ 0.2 (μC - 50) versus Ha: μC - μL \> 0.2 (μC - 50)"||4.3||0.0001
74040220|NCT05053126|147632687|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.84||0.0099|ONE_SIDED|95.0||8.0|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μL ≤ 0.2 (μC - 50) versus Ha: μC - μL \> 0.2 (μC - 50)"||8.0||0.0099
74040221|NCT05053126|147632687|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|18.2|STANDARD_ERROR_OF_MEAN|3.13||0.9888|ONE_SIDED|95.0||23.4|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μL - μp ≥ δ2 versus Ha: μL - μp \< δ2 where δ2 = 11"||23.4||0.9888
74040222|NCT05053126|147632687|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|22.0|STANDARD_ERROR_OF_MEAN|3.13||0.9997|ONE_SIDED|95.0||27.1|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μL - μp ≥ δ2 versus Ha: μL - μp \< δ2 where δ2 = 11"||27.1||0.9997
74040223|NCT05053126|147632688|OTHER||Mean Difference (Final Values)|75.6|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|65.79|85.42|||Mixed Models Analysis|||||85.42|65.79|<0.0001
74040224|NCT05053126|147632688|OTHER||Mean Difference (Final Values)|44.84|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|35.03|54.65|||Mixed Models Analysis|||||54.65|35.03|<0.0001
74040225|NCT05053126|147632688|OTHER||Mean Difference (Final Values)|49.93|STANDARD_ERROR_OF_MEAN|5.945|<|0.0001|TWO_SIDED|90.0|40.12|59.75|||Mixed Models Analysis|||||59.75|40.12|<0.0001
74040226|NCT05053126|147632688|OTHER||Mean Difference (Final Values)|80.8|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|70.99|90.61|||Mixed Models Analysis|||||90.61|70.99|<0.0001
74040227|NCT05053126|147632688|OTHER||Mean Difference (Final Values)|81.91|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|72.09|91.73|||Mixed Models Analysis|||||91.73|72.09|<0.0001
74040228|NCT05053126|147632688|OTHER||Mean Difference (Final Values)|-30.8|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|-40.6|-20.9|||Mixed Models Analysis|||||-20.9|-40.6|<0.0001
74040229|NCT05053126|147632688|OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|-35.5|-15.9|||Mixed Models Analysis|||||-15.9|-35.5|<0.0001
74040230|NCT05053126|147632688|OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.945||0.3829|TWO_SIDED|90.0|-4.62|15.01|||Mixed Models Analysis|||||15.01|-4.62|0.3829
74040231|NCT05053126|147632688|OTHER||Mean Difference (Final Values)|6.31|STANDARD_ERROR_OF_MEAN|5.942||0.2896|TWO_SIDED|90.0|-3.5|16.11|||Mixed Models Analysis|||||16.11|-3.50|0.2896
74092477|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092478|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
74092479|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092480|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092481|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092482|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
74092483|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092484|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092485|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092486|NCT02504671|147737905|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092487|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092488|NCT02504671|147737905|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74092489|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74040232|NCT05053126|147632689|OTHER||Mean Difference (Final Values)|23.47|STANDARD_ERROR_OF_MEAN|2.247|<|0.0001|TWO_SIDED|90.0|19.77|27.17|||Mixed Models Analysis|||||27.17|19.77|<0.0001
74040233|NCT05053126|147632689|OTHER||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|2.239|<|0.0001|TWO_SIDED|90.0|6.71|14.09|||Mixed Models Analysis|||||14.09|6.71|<0.0001
74040234|NCT05053126|147632689|OTHER||Mean Difference (Final Values)|11.29|STANDARD_ERROR_OF_MEAN|2.248|<|0.0001|TWO_SIDED|90.0|7.59|14.99|||Mixed Models Analysis|||||14.99|7.59|<0.0001
74040235|NCT05053126|147632689|OTHER||Mean Difference (Final Values)|24.33|STANDARD_ERROR_OF_MEAN|2.251|<|0.0001|TWO_SIDED|90.0|20.62|28.03|||Mixed Models Analysis|||||28.03|20.62|<0.0001
74040236|NCT05053126|147632689|OTHER||Mean Difference (Final Values)|22.34|STANDARD_ERROR_OF_MEAN|2.245|<|0.0001|TWO_SIDED|90.0|18.65|26.04|||Mixed Models Analysis|||||26.04|18.65|<0.0001
74040237|NCT05053126|147632689|OTHER||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.245|<|0.0001|TWO_SIDED|90.0|-16.8|-9.38|||Mixed Models Analysis|||||-9.38|-16.8|<0.0001
74040238|NCT05053126|147632689|OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|2.252|<|0.0001|TWO_SIDED|90.0|-15.9|-8.47|||Mixed Models Analysis|||||-8.47|-15.9|<0.0001
74092490|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
74092491|NCT02504671|147737905|OTHER||Difference|29.7|||||TWO_SIDED|95.0|12.7|46.8|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.8|12.7|
74092492|NCT02504671|147737905|OTHER||Difference|37.8|||||TWO_SIDED|95.0|20.3|55.4|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.4|20.3|
74040239|NCT05053126|147632689|OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|2.258||0.7051|TWO_SIDED|90.0|-2.86|4.57|||Mixed Models Analysis|||||4.57|-2.86|0.7051
74040240|NCT05053126|147632689|OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|2.246||0.616|TWO_SIDED|90.0|-4.82|2.57|||Mixed Models Analysis|||||2.57|-4.82|0.6160
74040241|NCT05053126|147632690|OTHER||Mean Difference (Final Values)|21.99|STANDARD_ERROR_OF_MEAN|2.235|<|0.0001|TWO_SIDED|90.0|18.31|25.67|||Mixed Models Analysis|||||25.67|18.31|<0.0001
74040242|NCT05053126|147632690|OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|2.227||0.0042|TWO_SIDED|90.0|2.73|10.07|||Mixed Models Analysis|||||10.07|2.73|0.0042
74040243|NCT05053126|147632690|OTHER||Mean Difference (Final Values)|9.8|STANDARD_ERROR_OF_MEAN|2.236|<|0.0001|TWO_SIDED|90.0|6.12|13.48|||Mixed Models Analysis|||||13.48|6.12|<0.0001
74092493|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092494|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74040244|NCT05053126|147632690|OTHER||Mean Difference (Final Values)|21.12|STANDARD_ERROR_OF_MEAN|2.239|<|0.0001|TWO_SIDED|90.0|17.44|24.81|||Mixed Models Analysis|||||24.81|17.44|<0.0001
74092495|NCT02504671|147737905|OTHER||Difference|37.8|||||TWO_SIDED|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.1|19.5|
74092496|NCT02504671|147737905|OTHER||Difference|51.4|||||TWO_SIDED|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.1|19.5|
74092497|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
74092498|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
74092499|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 4, ACR70. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092500|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-6.8|33.8|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.8|-6.8|
74092501|NCT02504671|147737905|OTHER||Difference|24.3|||||TWO_SIDED|95.0|3.5|45.2|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||45.2|3.5|
74040245|NCT05053126|147632690|OTHER||Mean Difference (Final Values)|21.27|STANDARD_ERROR_OF_MEAN|2.233|<|0.0001|TWO_SIDED|90.0|17.59|24.95|||Mixed Models Analysis|||||24.95|17.59|<0.0001
74040246|NCT05053126|147632690|OTHER||Mean Difference (Final Values)|-15.6|STANDARD_ERROR_OF_MEAN|2.233|<|0.0001|TWO_SIDED|90.0|-19.3|-11.9|||Mixed Models Analysis|||||-11.9|-19.3|<0.0001
74040247|NCT05053126|147632690|OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|90.0|-15.9|-8.5|||Mixed Models Analysis|||||-8.50|-15.9|<0.0001
74040248|NCT05053126|147632690|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|2.246||0.7001|TWO_SIDED|90.0|-4.56|2.83|||Mixed Models Analysis|||||2.83|-4.56|0.7001
74092502|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.6|-12.2|
74092503|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.6|-12.2|
74092504|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74040249|NCT05053126|147632690|OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|2.233||0.7479|TWO_SIDED|90.0|-4.4|2.96|||Mixed Models Analysis|||||2.96|-4.40|0.7479
74040250|NCT05053126|147632691|OTHER||Mean Difference (Final Values)|27.82|STANDARD_ERROR_OF_MEAN|1.439|<|0.0001|TWO_SIDED|90.0|25.45|30.19|||Mixed Models Analysis|||||30.19|25.45|<0.0001
74040251|NCT05053126|147632691|OTHER||Mean Difference (Final Values)|14.53|STANDARD_ERROR_OF_MEAN|1.435|<|0.0001|TWO_SIDED|90.0|12.17|16.89|||Mixed Models Analysis|||||16.89|12.17|<0.0001
74040252|NCT05053126|147632691|OTHER||Mean Difference (Final Values)|17.85|STANDARD_ERROR_OF_MEAN|1.437|<|0.0001|TWO_SIDED|90.0|15.49|20.22|||Mixed Models Analysis|||||20.22|15.49|<0.0001
74040253|NCT05053126|147632691|OTHER||Mean Difference (Final Values)|34.4|STANDARD_ERROR_OF_MEAN|1.438|<|0.0001|TWO_SIDED|90.0|34.4|36.77|||Mixed Models Analysis|||||36.77|34.40|<0.0001
74040254|NCT05053126|147632691|OTHER||Mean Difference (Final Values)|38.84|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|90.0|36.47|41.21|||Mixed Models Analysis|||||41.21|36.47|<0.0001
74040255|NCT05053126|147632691|OTHER||Mean Difference (Final Values)|-13.3|STANDARD_ERROR_OF_MEAN|1.434|<|0.0001|TWO_SIDED|90.0|-15.6|-10.9|||Mixed Models Analysis|||||-10.9|-15.6|<0.0001
74040256|NCT05053126|147632691|OTHER||Mean Difference (Final Values)|-9.97|STANDARD_ERROR_OF_MEAN|1.435|<|0.0001|TWO_SIDED|90.0|-12.3|-7.61|||Mixed Models Analysis|||||-7.61|-12.3|<0.0001
74040257|NCT05053126|147632691|OTHER||Mean Difference (Final Values)|6.58|STANDARD_ERROR_OF_MEAN|1.436|<|0.0001|TWO_SIDED|90.0|4.22|8.94|||Mixed Models Analysis|||||8.94|4.22|<0.0001
74040258|NCT05053126|147632691|OTHER||Mean Difference (Final Values)|11.02|STANDARD_ERROR_OF_MEAN|1.436|<|0.0001|TWO_SIDED|90.0|8.65|13.38|||Mixed Models Analysis|||||13.38|8.65|<0.0001
74040259|NCT01376245|147632696|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|||<|0.001|TWO_SIDED|95.0|0.089|0.191|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.191|0.089|<0.001
74040260|NCT01376245|147632696|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.179|||<|0.001|TWO_SIDED|95.0|0.129|0.23|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.230|0.129|<0.001
74092505|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74040261|NCT01376245|147632696|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.194|||<|0.001|TWO_SIDED|95.0|0.143|0.245|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.245|0.143|<0.001
74040262|NCT01357889|147632714|NON_INFERIORITY_OR_EQUIVALENCE|To establish BE, the 90% CI for the ratio of Process 3 (P3) to Process 2 (P2) geometric least squares means (LSMs) for AUC (0-inf) must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.937|||||TWO_SIDED|90.0|0.842|1.042|||ANOVA|||||1.042|0.842|
74040263|NCT01357889|147632715|NON_INFERIORITY_OR_EQUIVALENCE|To establish BE, the 90% CI for the ratio of Process 3:Process 2 geometric least squares means for Cmax must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.927|||||TWO_SIDED|90.0|0.813|1.056|||ANOVA|||||1.056|0.813|
74092506|NCT02504671|147737905|OTHER||Difference|32.4|||||TWO_SIDED|95.0|12.4|52.4|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||52.4|12.4|
74040264|NCT01021813|147632756|SUPERIORITY_OR_OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-1.1|1.4|||Miettinen & Nurminen Method.|||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any sleep paralysis AEs between the Suvorexant group and Placebo group .||1.4|-1.1|
74040265|NCT01021813|147632757|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.482|TWO_SIDED|95.0|-1.3|1.1|||Miettinen & Nurminen Method.|||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any complex sleep-related behaviors AEs between the Suvorexant group and Placebo group.||1.1|-1.3|0.482
74040266|NCT01021813|147632758|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.8||||0.508|TWO_SIDED|95.0|-3.9|1.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any falls AEs between the Suvorexant group and Placebo group.||1.5|-3.9|0.508
74040267|NCT01021813|147632759|SUPERIORITY_OR_OTHER||Difference in Percentage of AEs|0.8||||0.159|TWO_SIDED|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any suicidal ideation/behavior AEs considered an ECI between the Suvorexant group and Placebo group.||2.0|-0.7|0.159
74040268|NCT01021813|147632760|SUPERIORITY_OR_OTHER||Difference in Percentage|0.8||||0.159|TWO_SIDED|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any Hypnagogic/hypnopompic hallucinations AEs between the Suvorexant group and Placebo group.||2.0|-0.7|0.159
74040269|NCT01021813|147632761|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4||||0.767|TWO_SIDED|95.0|-3.8|2.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any selected AEs associated with potential abuse between the Suvorexant group and Placebo group.||2.2|-3.8|0.767
74092507|NCT02504671|147737905|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
74092508|NCT02504671|147737905|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
74092509|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
73879044|NCT03192176|147297606|SUPERIORITY||-2.6|-2.6|STANDARD_ERROR_OF_MEAN|0.74||0.0005|TWO_SIDED|95.0|-4.04|-1.15||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.15|-4.04|0.0005
74009434|NCT01092143|147569697|SUPERIORITY||Adjusted mean treatment differences|-0.08|STANDARD_DEVIATION|0.11||0.2335|TWO_SIDED|95.0|-0.296|0.136||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.136|-0.296|0.2335
74009435|NCT01092143|147569697|SUPERIORITY||Adjusted mean treatment differences|-0.061|STANDARD_DEVIATION|0.113||0.2933|TWO_SIDED|95.0|-0.282|0.16||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.160|-0.282|0.2933
74009436|NCT01092143|147569697|SUPERIORITY||Adjusted mean treatment differences|-0.333|STANDARD_DEVIATION|0.116||0.0021|TWO_SIDED|95.0|-0.561|-0.105||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||-0.105|-0.561|0.0021
74009437|NCT01092143|147569697|SUPERIORITY||Adjusted mean treatment differences|0.406|STANDARD_DEVIATION|0.114||0.9998|TWO_SIDED|95.0|0.183|0.63||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.630|0.183|0.9998
74009438|NCT01092143|147569697|SUPERIORITY||Adjusted mean treatment differences|0.253|STANDARD_DEVIATION|0.11||0.989|TWO_SIDED|95.0|0.037|0.47||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.470|0.037|0.9890
74009439|NCT01092143|147569697|SUPERIORITY||Adjusted mean treatment differences|0.272|STANDARD_DEVIATION|0.113||0.9918|TWO_SIDED|95.0|0.05|0.494||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.494|0.050|0.9918
74009440|NCT00545402|147569728|SUPERIORITY_OR_OTHER|||||||0.2611|||||||Log Rank|||||||0.2611
73879045|NCT03192176|147297606|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0063|TWO_SIDED|95.0|-3.52|-0.59||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.59|-3.52|0.0063
73879046|NCT03192176|147297607|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0215|TWO_SIDED|95.0|-0.84|-0.07||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.07|-0.84|0.0215
74009441|NCT00545402|147569730|SUPERIORITY_OR_OTHER|||||||0.7091|||||||Log Rank|||||||0.7091
74009442|NCT01721876|147569734|SUPERIORITY|The 2-sided test of the hypothesis was performed at a 0.05 level of significance. An odds ratio (OR) = 1 would indicate that the odds of achieving CR+CRi with Volasertib + Low-dose Cytarabine is equal to the odds of achieving CR+CRi with Placebo + Low-dose Cytarabine , whereas an OR ≠ 1 would indicate the opposite. H0, CR+CRi: OR = 1 vs. Ha, CR+CRi: OR ≠ 1.|Odds Ratio (OR)|1.8751||||0.0024|TWO_SIDED|95.0|1.2432|2.8281|||Cochran-Mantel-Haenszel||Common odds ratio is calculated by Mantel-Haenszel estimate adjusting for the two stratification factors (baseline Eastern Cooperative Oncology Group (ECOG) and type of AML). If odds ratio is above 1 then it favours Volasertib+Low-dose Cytarabine.|This analysis was exploratory and descriptive.||2.8281|1.2432|0.0024
74009443|NCT01721876|147569735|SUPERIORITY|The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.|Hazard Ratio (HR)|0.97||||0.7571|TWO_SIDED|95.0|0.8|1.2||P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).|Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|This analysis was exploratory and descriptive.||1.2|0.8|0.7571
74009444|NCT01721876|147569736|SUPERIORITY|The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.|Hazard Ratio (HR)|0.96||||0.6718|TWO_SIDED|95.0|0.8|1.2||P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).|Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|This analysis was exploratory and descriptive.||1.2|0.8|0.6718
74009445|NCT01721876|147569737|OTHER||Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.7|2.7|||Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|||2.7|0.7|
74009446|NCT03086265|147569738|OTHER|||||||0.7934|||||||t-test, 2 sided|||||||0.7934
74009447|NCT03086265|147569747|OTHER|||||||0.6876|||||||t-test, 2 sided|||||||0.6876
74009448|NCT03086265|147569748|OTHER|||||||0.7549|||||||t-test, 2 sided|||||||0.7549
74009449|NCT03086265|147569749|OTHER|||||||0.6479|||||||t-test, 2 sided|||||||0.6479
74009450|NCT03086265|147569750|OTHER|||||||0.8322|||||||t-test, 2 sided|||||||0.8322
74009451|NCT03086265|147569752|OTHER|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
74009452|NCT03086265|147569753|OTHER|||||||0.3346|||||||t-test, 2 sided|||||||0.3346
74009453|NCT03086265|147569754|OTHER|||||||0.5513|||||||t-test, 2 sided|||||||0.5513
74009454|NCT03086265|147569755|OTHER|||||||0.1927|||||||t-test, 2 sided|||||||0.1927
74009455|NCT03086265|147569756|OTHER|||||||0.6483|||||||t-test, 2 sided|||||||0.6483
74009456|NCT03086265|147569757|OTHER|||||||0.5625|||||||t-test, 2 sided|||||||0.5625
74009457|NCT03086265|147569758|OTHER|||||||0.2827|||||||t-test, 2 sided|||||||0.2827
74009458|NCT03086265|147569759|OTHER|||||||0.8426|||||||t-test, 2 sided|||||||0.8426
74009459|NCT03086265|147569760|OTHER|||||||0.9856|||||||t-test, 2 sided|||||||0.9856
74092510|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
73879047|NCT03192176|147297607|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0017|TWO_SIDED|95.0|-1.01|-0.24||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.24|-1.01|0.0017
73879048|NCT03192176|147297607|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.21|-0.44||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.44|-1.21|<0.0001
73879049|NCT03192176|147297607|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.37|-0.59||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.59|-1.37|<0.0001
73879050|NCT03192176|147297607|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0322|TWO_SIDED|95.0|-0.81|-0.04||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.04|-0.81|0.0322
73879051|NCT03192176|147297607|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0017|TWO_SIDED|95.0|-0.99|-0.23||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.23|-0.99|0.0017
74009460|NCT03086265|147569761|OTHER|||||||0.8112|||||||t-test, 2 sided|||||||0.8112
74009461|NCT03086265|147569762|OTHER|||||||0.6587|||||||t-test, 2 sided|||||||0.6587
74009462|NCT03086265|147569763|OTHER|||||||0.4143|||||||t-test, 2 sided|||||||0.4143
74009463|NCT03086265|147569764|OTHER|||||||0.4324|||||||t-test, 2 sided|||||||0.4324
74009464|NCT03086265|147569765|OTHER|||||||0.7221|||||||t-test, 2 sided|||Comparison of preoperative scores.||||0.7221
74009465|NCT03086265|147569765|OTHER|||||||0.0336|||||||t-test, 2 sided|||Comparison of postoperative scores.||||0.0336
74009466|NCT01721057|147569766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Regression, Logistic|||||||0.001
74009467|NCT01202279|147569787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||Fisher Exact|||||||0.025
74009468|NCT01202279|147569788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||ANCOVA|||||||0.022
74009469|NCT00257166|147569812|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-5.22|STANDARD_ERROR_OF_MEAN|1.48||0.0005|TWO_SIDED|95.0|-8.12|-2.31|||ANCOVA|||Change at Week 4: Mixed effects repeated measures Analysis of Covariance (ANCOVA) model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-2.31|-8.12|0.0005
74009470|NCT00257166|147569813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.2545|STANDARD_ERROR_OF_MEAN|0.9422||0.0006|TWO_SIDED|95.0|-5.1045|-1.4046|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-1.4046|-5.1045|0.0006
74009471|NCT00257166|147569813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.5857|STANDARD_ERROR_OF_MEAN|1.4184||0.0117|TWO_SIDED|95.0|-6.3705|-0.8009|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.8009|-6.3705|0.0117
74009472|NCT00257166|147569813|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.8665|STANDARD_ERROR_OF_MEAN|1.7154||0.0047|TWO_SIDED|95.0|-8.2345|-1.4985|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-1.4985|-8.2345|0.0047
74009473|NCT00257166|147569814|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3754|STANDARD_ERROR_OF_MEAN|0.0989||0.0002|TWO_SIDED|95.0|-0.5696|-0.1812|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.1812|-0.5696|0.0002
74009474|NCT00257166|147569814|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5596|STANDARD_ERROR_OF_MEAN|0.1355|<|0.0001|TWO_SIDED|95.0|-0.8256|-0.2936|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.2936|-0.8256|<0.0001
74009475|NCT00257166|147569814|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6798|STANDARD_ERROR_OF_MEAN|0.1643|<|0.0001|TWO_SIDED|95.0|-1.0024|-0.3572|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.3572|-1.0024|<0.0001
74009476|NCT00257166|147569814|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6884|STANDARD_ERROR_OF_MEAN|0.1761||0.0001|TWO_SIDED|95.0|-1.0342|-0.3426|||ANCOVA|||Change at Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.3426|-1.0342|0.0001
74092511|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
74092512|NCT02504671|147737905|OTHER||Difference|29.7|||||TWO_SIDED|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.4|11.0|
74092513|NCT02504671|147737905|OTHER||Difference|40.5|||||TWO_SIDED|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||59.5|21.6|
73879052|NCT03192176|147297607|SUPERIORITY||LSMean differencce|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0004|TWO_SIDED|95.0|-1.08|-0.31||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.31|-1.08|0.0004
73879053|NCT03192176|147297608|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2324|TWO_SIDED|95.0|-0.67|-0.16||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.16|-0.67|0.2324
73879054|NCT03192176|147297608|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0736|TWO_SIDED|95.0|-0.8|0.04||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.04|-0.80|0.0736
73879055|NCT03192176|147297608|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.008|TWO_SIDED|95.0|-0.98|-0.15||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.15|-0.98|0.0080
73879056|NCT03192176|147297608|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.0028|TWO_SIDED|95.0|-1.07|-0.22||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.22|-1.07|0.0028
74040270|NCT01021813|147632762|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|-0.81||||0.567|TWO_SIDED|95.0|-5.1|3.1|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||3.1|-5.1|0.567
74040271|NCT01021813|147632762|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|-2.4||||0.185|TWO_SIDED|95.0|-7.3|1.6|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||1.6|-7.3|0.185
74040272|NCT01021813|147632762|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|-0.78||||0.68|TWO_SIDED|95.0|-5.6|3.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||3.9|-5.6|0.680
74040273|NCT01021813|147632762|SUPERIORITY_OR_OTHER||Difference in Percentage: Across Nights|0.0||||1|TWO_SIDED|95.0|-6.4|6.4|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms across Nights 1, 2, and 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||6.4|-6.4|1.000
74040274|NCT01021813|147632763|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|5.03||||0.365|TWO_SIDED|95.0|-5.8|15.8|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.8|-5.8|0.365
74040275|NCT01021813|147632763|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|8.72||||0.109|TWO_SIDED|95.0|-2.0|19.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||19.2|-2.0|0.109
74040276|NCT01021813|147632763|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|6.02||||0.287|TWO_SIDED|95.0|-5.1|16.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||16.9|-5.1|0.287
73879057|NCT03192176|147297608|SUPERIORITY||LSMean differnce|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4647|TWO_SIDED|95.0|-0.58|0.26||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.26|-0.58|0.4647
74092514|NCT02504671|147737905|OTHER||Difference|21.6|||||TWO_SIDED|95.0|4.5|38.8|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.8|4.5|
74092515|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
74092516|NCT02504671|147737905|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
73879058|NCT03192176|147297608|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.016|TWO_SIDED|95.0|-0.92|-0.1||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.10|-0.92|0.0160
74092517|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
73879059|NCT03192176|147297608|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0901|TWO_SIDED|95.0|-0.78|0.06||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.06|-0.78|0.0901
73879060|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.79||0.0865|TWO_SIDED|95.0|-2.92|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||0.20|-2.92|0.0865
73879061|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0009|TWO_SIDED|95.0|-4.22|-1.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.10|-4.22|0.0009
73879062|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.79|<|1e-05|TWO_SIDED|95.0|-5.06|-1.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.94|-5.06|<0.00001
73879063|NCT03192176|147297609|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|1e-05|TWO_SIDED|95.0|-5.63|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.47|-5.63|<0.00001
73879064|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.81||0.236|TWO_SIDED|95.0|-2.55|0.63||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.63|-2.55|0.2360
73879065|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|-2.4||0.0032|TWO_SIDED|95.0|-3.92|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.80|-3.92|0.0032
73879066|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0006|TWO_SIDED|95.0|-4.29|-1.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.19|-4.29|0.0006
73879067|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.82||0.1318|TWO_SIDED|95.0|-2.86|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.38|-2.86|0.1318
73879068|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.83||0.0014|TWO_SIDED|95.0|-4.3|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.04|-4.30|0.0014
74009477|NCT00257166|147569815|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.21||0.0004|TWO_SIDED|95.0|-1.18|-0.34|||ANCOVA|||Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects was used for the analysis.||-0.34|-1.18|0.0004
73879069|NCT03192176|147297609|SUPERIORITY||LSMean differencce|-3.2|STANDARD_ERROR_OF_MEAN|0.82||0.0001|TWO_SIDED|95.0|-4.82|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.58|-4.82|0.0001
73879070|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED|95.0|-5.3|-2.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.00|-5.30|<0.0001
73879071|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.84||0.0752|TWO_SIDED|95.0|-3.15|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.15|-3.15|0.0752
73879072|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.83||0.0343|TWO_SIDED|95.0|-3.38|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.13|-3.38|0.0343
73879073|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.82||0.0049|TWO_SIDED|95.0|-3.95|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.71|-3.95|0.0049
74009478|NCT00525044|147569822|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.028||0.0156|TWO_SIDED|95.0|-0.12|-0.01|||ANOVA||Treatment differences (Ambroxol- Placebo)|"Differences between the treatment groups with regard to the primary endpoint SPIDnorm was tested using an analysis of variance (ANOVA) including treatment and centre as fix effects.~Treatment differences were estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.01|-0.12|0.0156
74092518|NCT02504671|147737905|OTHER||Difference|24.3|||||TWO_SIDED|95.0|4.5|44.1|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.1|4.5|
74009479|NCT00525044|147569823|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0|-0.4|0.1280
74009480|NCT00525044|147569823|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0417|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.0417
74009481|NCT00525044|147569823|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0054|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.1|-0.6|0.0054
74009482|NCT00525044|147569823|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0201|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.6|0.0201
74009483|NCT00525044|147569824|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.1280
74009484|NCT00525044|147569824|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0417|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.0417
74009485|NCT00525044|147569824|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0054|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.1|-0.6|0.0054
74009486|NCT00525044|147569824|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0201|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.6|0.0201
74009487|NCT00525044|147569825|OTHER|||||||0.9939|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.9939
74040277|NCT01021813|147632763|SUPERIORITY_OR_OTHER||Difference in Percentage:Night 1, 2 or 3|10.82||||0.057|TWO_SIDED|95.0|-0.3|21.7|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||21.7|-0.3|0.057
74009488|NCT00525044|147569825|OTHER|||||||0.5552|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.5552
74009489|NCT00525044|147569826|OTHER|||||||0.0343|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.0343
74009490|NCT00525044|147569826|OTHER|||||||0.0119|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.0119
74009491|NCT02161575|147569901|SUPERIORITY||Median Difference (Final Values)|-30.75|||<|0.0001|TWO_SIDED|95.0|-59.5|-20.5|||Wilcoxon (Mann-Whitney)|Confidence Interval for the Median Change form Baseline||The null hypothesis was that the change in CSRT from baseline to Day 90 was zero||-20.50|-59.50|<0.0001
74009492|NCT01390272|147569997|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-2.1||||0.26|TWO_SIDED|95.0|-5.9|1.6|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||1.6|-5.9|0.26
74009493|NCT01390272|147569998|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-1.3||||0.5|TWO_SIDED|95.0|-4.9|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||2.4|-4.9|0.50
74009494|NCT01390272|147569999|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-1.6||||0.43|TWO_SIDED|95.0|-5.6|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||2.4|-5.6|0.43
74009495|NCT01390272|147570001|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.0||||0.83|TWO_SIDED|95.0|0.7|1.6|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 6 months||1.6|0.7|0.83
74092519|NCT02504671|147737905|OTHER||Difference|51.4|||||TWO_SIDED|95.0|32.2|70.5|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.5|32.2|
74009496|NCT01390272|147570002|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|0.9||||0.53|TWO_SIDED|95.0|0.5|1.4|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 12 months||1.4|0.5|0.53
74009497|NCT01390272|147570003|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.5||||0.09|TWO_SIDED|95.0|0.9|2.3|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 18 months.||2.3|0.9|0.09
74009498|NCT01390272|147570006|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.0||||0.95|TWO_SIDED|95.0|0.7|1.5|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variable of diabetes status and diabetes control.||||1.5|0.7|0.95
74009499|NCT01390272|147570007|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.4||||0.12|TWO_SIDED|95.0|0.9|2.1|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link.Adjusted for baseline stratification variable of diabetes status and blood pressure control.||Comparison at 12 months||2.1|0.9|0.12
74009500|NCT01390272|147570008|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.2||||0.3|TWO_SIDED|95.0|0.8|1.9|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status and blood pressure control.||Comparison at 18 months||1.9|0.8|0.30
74009501|NCT01854645|147570035|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
74009502|NCT01854645|147570035|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
74009503|NCT01854645|147570035|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
74092520|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
74009504|NCT01854645|147570035|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
74009505|NCT01854645|147570035|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
74009506|NCT01854645|147570035|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
74009507|NCT02064920|147570070|SUPERIORITY_OR_OTHER||Change in SD from Week 4 to Week 16|0.005|||||TWO_SIDED|95.0|-0.031|0.039|||||SD of average OCL repeated measurements after 12 weeks of treatment for Placebo + Donezepil treatment groups combined is hypothesized to be ≤ 0.1.|Change from Week 4 to Week 16 in Standard Deviation (SD) of OCL for Placebo + Donezepil treatment groups combined||0.039|-0.031|
74009508|NCT02109562|147570078|SUPERIORITY||Mean Difference (Final Values)|-6.148|STANDARD_ERROR_OF_MEAN|1.7261||0.0004|TWO_SIDED|95.0|-9.982|-2.314||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-2.314|-9.982|0.0004
74009509|NCT02109562|147570078|SUPERIORITY||Mean Difference (Final Values)|-7.237|STANDARD_ERROR_OF_MEAN|1.7141|<|0.0001|TWO_SIDED|95.0|-11.045|-3.429||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-3.429|-11.045|<0.0001
74009510|NCT02109562|147570079|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0934||0.0002|TWO_SIDED|95.0|-0.557|-0.143||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-0.143|-0.557|0.0002
74009511|NCT02109562|147570079|SUPERIORITY||Mean Difference (Final Values)|-0.396|STANDARD_ERROR_OF_MEAN|0.0928|<|0.0001|TWO_SIDED|95.0|-0.602|-0.19||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-0.190|-0.602|<0.0001
74009512|NCT00688155|147570090|EQUIVALENCE|Two-sided test of mean differences from baseline.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.25||0.66|TWO_SIDED|||||Physical activity training versus no physical activity training;|ANOVA|||Marginal comparisons of physical activity training vs no physical activity training||||0.66
74009513|NCT00688155|147570090|EQUIVALENCE|Two-sided tests of mean differences from baseline.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.26||0.55|TWO_SIDED|||||P-value for physical activity training is 0.55|ANOVA|||Marginal comparisons of physical activity training versus no physical activity training||||0.55
74092521|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
74092522|NCT02504671|147737905|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 16, ACR70. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
74092523|NCT02504671|147737905|OTHER||Difference|21.6|||||TWO_SIDED|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|
74009514|NCT00688155|147570090|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.25||0.95|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.95
74009515|NCT00688155|147570090|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.26||0.48|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.48
74009516|NCT00688155|147570092|EQUIVALENCE|Two-sided tests of marginal means|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.29||0.23|TWO_SIDED||||||ANOVA|||Marginal comparisons of physical activity training versus no physical activity training.||||0.23
74009517|NCT00688155|147570092|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.29||0.42|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.42
74009518|NCT04136184|147570120|SUPERIORITY||Difference in LS Mean|-24.7593||||1e-08|TWO_SIDED|95.0|-30.9552|-18.5635|||MMRM|||||-18.5635|-30.9552|0.00000001
74009519|NCT04136184|147570121|SUPERIORITY||Difference in LS Mean|-19.7352||||1e-08|TWO_SIDED|95.0|-25.6301|-13.8403|||MMRM|||||-13.8403|-25.6301|0.00000001
74009520|NCT04136184|147570122|SUPERIORITY||Difference in LS Mean|-70.42||||1e-08|TWO_SIDED|95.0|-75.17|-65.66|||MMRM|||||-65.66|-75.17|0.00000001
74009521|NCT04136184|147570123|SUPERIORITY||Difference in LS Mean|-66.65||||1e-08|TWO_SIDED|95.0|-71.59|-61.71|||MMRM|||||-61.71|-71.59|0.00000001
74009522|NCT04136184|147570124|SUPERIORITY||Difference in LS Mean|-9.3542||||0.00012203|TWO_SIDED|95.0|-13.8691|-4.8394|||MMRM|||||-4.8394|-13.8691|0.00012203
74009523|NCT04136184|147570125|SUPERIORITY||Difference in LS Mean|-11.8202||||1.873e-05|TWO_SIDED|95.0|-16.8927|-6.7477|||MMRM|||||-6.7477|-16.8927|0.00001873
74009524|NCT04136184|147570126|SUPERIORITY||Difference in LS Mean|-3.94||||0.00052447|TWO_SIDED|95.0|-6.08|-1.8|||MMRM|||Week 35||-1.80|-6.08|0.00052447
74009525|NCT04136184|147570126|SUPERIORITY||Difference in LS Mean|-8.21||||1e-08|TWO_SIDED|95.0|-10.65|-5.76|||MMRM|||Week 66||-5.76|-10.65|0.00000001
74009526|NCT04136184|147570127|SUPERIORITY||Difference in LS Mean|5.305||||5.58e-06|TWO_SIDED|95.0|3.195|7.416|||MMRM|||||7.416|3.195|0.00000558
74009527|NCT04136184|147570128|SUPERIORITY||Difference in LS Mean|-0.2||||0.02407897|TWO_SIDED|95.0|-0.4|0.0|||MMRM|||||-0.0|-0.4|0.02407897
74009528|NCT04136184|147570129|SUPERIORITY||Difference in LS Mean|82.6991||||2e-07|TWO_SIDED|95.0|54.6431|110.7551|||MMRM|||||110.7551|54.6431|0.00000020
74009529|NCT03734016|147570190|NON_INFERIORITY|Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.|Response ratio|1.12|||<|0.0001|TWO_SIDED|95.0|1.04|1.22|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.22|1.04|<0.0001
74009530|NCT03734016|147570190|SUPERIORITY|||||||0.0035||||||Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0035
74009531|NCT03734016|147570191|NON_INFERIORITY|Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.|Response ratio|1.14|||<|0.0001|TWO_SIDED|95.0|1.05|1.22|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.22|1.05|<0.0001
74009532|NCT03734016|147570191|SUPERIORITY|Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.||||||0.0007|||||||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0007
74009533|NCT03734016|147570192|NON_INFERIORITY|Non-inferiority was tested with a non-inferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.|Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.86|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.86|0.49|<0.0001
74009534|NCT03734016|147570192|SUPERIORITY|||||||0.0024|||||||Stratified Log-rank test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0024
74009535|NCT03734016|147570193|NON_INFERIORITY|Noninferiority was tested with a noninferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.|Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.86||Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Stratified Wald test||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.86|0.49|<0.0001
74009536|NCT03734016|147570193|SUPERIORITY|||||||0.0024|||||||Stratified Log-rank test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0024
74009537|NCT03734016|147570194|SUPERIORITY||Rate Difference|-8.0||||0.0004|TWO_SIDED|95.0|-12.4|-3.6|||Chi-squared||Rate difference is the zanubrutinib rate minus the ibrutinib rate.|||-3.6|-12.4|0.0004
74040278|NCT01021813|147632764|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|4.46||||0.386|TWO_SIDED|95.0|-5.7|14.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||14.5|-5.7|0.386
74009538|NCT03734016|147570197|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.41|0.72|||||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.72|0.41|
74009539|NCT03734016|147570200|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.51|1.11|||||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.11|0.51|
74009540|NCT03734016|147570201|OTHER||Least Squares (LS) Mean Difference|3.0||||0.0338|TWO_SIDED|95.0|0.23|5.77|||Mixed model for repeated measures (MMRM)|||Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 24. A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.||5.77|0.23|0.0338
74009541|NCT03734016|147570201|OTHER||LS Mean Difference|1.34||||0.3304|TWO_SIDED|95.0|-1.37|4.06|||Mixed model for repeated measures (MMRM)|||Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 48. A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.||4.06|-1.37|0.3304
74009542|NCT03734016|147570201|OTHER||LS Mean Difference|1.82||||0.1189|TWO_SIDED|95.0|-0.47|4.12|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||4.12|-0.47|0.1189
74009543|NCT03734016|147570201|OTHER||LS Mean Difference|1.15||||0.3274|TWO_SIDED|95.0|-1.15|3.44|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||3.44|-1.15|0.3274
74009544|NCT03734016|147570201|OTHER||LS Mean Difference|0.63||||0.6821|TWO_SIDED|95.0|-2.4|3.66|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||3.66|-2.40|0.6821
74009545|NCT03734016|147570201|OTHER||LS Mean Difference|1.8||||0.2701|TWO_SIDED|95.0|-1.4|5.0|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||5.00|-1.40|0.2701
74009546|NCT03734016|147570202|OTHER||LS Mean Difference|-1.91||||0.1778|TWO_SIDED|95.0|-4.7|0.87|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.87|-4.70|0.1778
74009547|NCT03734016|147570202|OTHER||LS Mean Difference|-0.35||||0.8174|TWO_SIDED|95.0|-3.32|2.62|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||2.62|-3.32|0.8174
74009548|NCT03734016|147570202|OTHER||LS Mean Difference|-0.29||||0.6294|TWO_SIDED|95.0|-1.48|0.89|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.89|-1.48|0.6294
74009549|NCT03734016|147570202|OTHER||LS Mean Difference|-0.51||||0.4933|TWO_SIDED|95.0|-1.99|0.96|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.96|-1.99|0.4933
74009550|NCT03734016|147570202|OTHER||LS Mean Difference|-1.43||||0.3643|TWO_SIDED|95.0|-4.51|1.66|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||1.66|-4.51|0.3643
74009551|NCT03734016|147570202|OTHER||LS Mean Difference|-2.43||||0.1363|TWO_SIDED|95.0|-5.62|0.77|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.77|-5.62|0.1363
74009552|NCT03734016|147570202|OTHER||LS Mean Difference|-1.59||||0.2001|TWO_SIDED|95.0|-4.01|0.84|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.84|-4.01|0.2001
74092524|NCT02504671|147737905|OTHER||Difference|43.2|||||TWO_SIDED|95.0|23.5|63.0|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||63.0|23.5|
74092525|NCT02504671|147737905|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.9|41.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.8|6.9|
74092526|NCT02504671|147737905|OTHER||Difference|21.6|||||TWO_SIDED|95.0|4.5|38.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.8|4.5|
74009553|NCT03734016|147570202|OTHER||LS Mean Difference|-1.85||||0.1121|TWO_SIDED|95.0|-4.12|0.43|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.43|-4.12|0.1121
74009554|NCT00418665|147570239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||||95.0|0.07|5.136|||||Romiplostim/placebo|||5.136|0.070|
74009555|NCT00418665|147570239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo|||1.071|0.022|
74009556|NCT00418665|147570240|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo|||1.071|0.022|
74009557|NCT00418665|147570240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.514||||||95.0|0.102|2.589|||||Romiplostim/placebo|||2.589|0.102|
74009558|NCT00418665|147570241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0||||||95.0|0.227|39.608|||||Romiplostim/placebo|||39.608|0.227|
74009559|NCT00418665|147570241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.714||||||95.0|0.144|20.473|||||Romiplostim/placebo|||20.473|0.144|
74009560|NCT00418665|147570242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.911||||||95.0|0.097|8.529|||||Romiplostim/placebo|||8.529|0.097|
74092527|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|3.3|34.5|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.5|3.3|
74009561|NCT00418665|147570242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.866||||||95.0|0.175|4.278|||||Romiplostim/placebo|||4.278|0.175|
74009562|NCT01133379|147570246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|4.75||0.811|TWO_SIDED|95.0|-10.5|8.24||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 6 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.24|-10.5|0.811
74009563|NCT01133379|147570246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|STANDARD_ERROR_OF_MEAN|4.75||0.105|TWO_SIDED|95.0|-17.1|1.63||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 6 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.63|-17.1|0.105
74009564|NCT01133379|147570247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|3.969||0.779|TWO_SIDED|95.0|-6.72|8.95||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 4 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.95|-6.72|0.779
74009565|NCT01133379|147570247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.92|STANDARD_ERROR_OF_MEAN|3.969||0.217|TWO_SIDED|95.0|-12.8|2.92||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 4 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.92|-12.8|0.217
74009566|NCT01133379|147570248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|2.613||0.904|TWO_SIDED|95.0|-4.84|5.47||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 2 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.47|-4.84|0.904
74009567|NCT01133379|147570248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.613||0.129|TWO_SIDED|95.0|-9.15|1.17||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 2 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.17|-9.15|0.129
74009568|NCT01133379|147570249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|1.336||0.477|TWO_SIDED|95.0|-3.59|1.69||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.69|-3.59|0.477
74092528|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
74092529|NCT02504671|147737905|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.3|7.7|
74092530|NCT02504671|147737905|OTHER||Difference|45.9|||||TWO_SIDED|95.0|26.7|65.2|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.2|26.7|
74092531|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-3.6|30.6|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.6|-3.6|
73879074|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.84||0.0285|TWO_SIDED|95.0|-3.5|-0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.20|-3.50|0.0285
74040279|NCT01021813|147632764|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|5.31||||0.311|TWO_SIDED|95.0|-5.0|15.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.5|-5.0|0.311
74040280|NCT01021813|147632764|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|4.96||||0.351|TWO_SIDED|95.0|-5.5|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.3|-5.5|0.351
74040281|NCT01021813|147632764|SUPERIORITY_OR_OTHER||Difference in Percentage:Night 1, 2 or 3|4.58||||0.409|TWO_SIDED|95.0|-6.3|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.3|-6.3|0.409
74040282|NCT01021813|147632765|SUPERIORITY_OR_OTHER||Difference in LS Means: Month 1|22.7|||<|0.0001|TWO_SIDED|95.0|16.4|29.0||To account for multiplicity, Hochberg's procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSTm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.||29.0|16.4|<0.0001
74040283|NCT01021813|147632766|SUPERIORITY_OR_OTHER||Difference in LS Means: Month 1|-9.5||||0.0002|TWO_SIDED|95.0|-14.6|-4.5||To account for multiplicity, Hochberg's procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSOm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.||-4.5|-14.6|0.0002
74040284|NCT00764478|147632768|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-3.5|STANDARD_ERROR_OF_MEAN|1.41||0.0136|TWO_SIDED|95.0|-6.3|-0.7||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-0.7|-6.3|0.0136
74040285|NCT00764478|147632768|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.0|STANDARD_ERROR_OF_MEAN|1.43||0.01|TWO_SIDED|95.0|-6.9|-1.2||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID|||-1.2|-6.9|0.0100
74040286|NCT00764478|147632769|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.01|TWO_SIDED|95.0|-0.8|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-0.2|-0.8|0.0100
74040287|NCT00764478|147632769|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.0052|TWO_SIDED|95.0|-0.9|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID|||-0.2|-0.9|0.0052
74040288|NCT00764478|147632770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5352||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel|||||||0.5352
74040289|NCT00764478|147632770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4274||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel|||||||0.4274
74040290|NCT00764478|147632771|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-2.7|STANDARD_ERROR_OF_MEAN|0.78||0.0007|TWO_SIDED|95.0|-4.2|-1.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2||-1.1|-4.2|0.0007
73879075|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.85||0.0004|TWO_SIDED|95.0|-4.69|-1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.37|-4.69|0.0004
74040291|NCT00764478|147632771|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.4|-1.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2||-1.3|-4.4|0.0003
74092532|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.7|-1.2|
74092533|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
74092534|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
73887951|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.4003|TWO_SIDED|95.0|-9.8|24.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.3|-9.8|0.4003
74040292|NCT00764478|147632771|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.6|STANDARD_ERROR_OF_MEAN|0.91|<|0.0001|TWO_SIDED|95.0|-5.4|-1.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||-1.8|-5.4|<0.0001
74040293|NCT00764478|147632771|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.7|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|-5.5|-1.9|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4||-1.9|-5.5|<0.0001
74040294|NCT00764478|147632771|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.5|STANDARD_ERROR_OF_MEAN|1.12||0.0021|TWO_SIDED|95.0|-5.7|-1.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-1.3|-5.7|0.0021
73879076|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|95.0|-5.14|-1.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.84|-5.14|<0.0001
73879077|NCT03192176|147297609|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-5.65|-2.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRm|||Week 3||-2.28|-5.65|<0.0001
73879078|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.86||0.0169|TWO_SIDED|95.0|-3.74|-0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.37|-3.74|0.0169
74009569|NCT01133379|147570249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|1.336||0.472|TWO_SIDED|95.0|-3.6|1.67||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.67|-3.60|0.472
74009570|NCT01133379|147570250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|2.726||0.86|TWO_SIDED|95.0|-5.86|4.9||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.90|-5.86|0.860
74040295|NCT00764478|147632771|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.2|STANDARD_ERROR_OF_MEAN|1.13||0.0002|TWO_SIDED|95.0|-6.4|-2.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-2.0|-6.4|0.0002
74040296|NCT00764478|147632771|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|1.35||0.1907|TWO_SIDED|95.0|-4.4|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-4.4|0.1907
74040297|NCT00764478|147632771|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.1|STANDARD_ERROR_OF_MEAN|1.37||0.0238|TWO_SIDED|95.0|-5.8|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.4|-5.8|0.0238
74040298|NCT00764478|147632772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2922|||||||Cochran-Mantel-Haenszel|||Day 2||||0.2922
74040299|NCT00764478|147632772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1001|||||||Cochran-Mantel-Haenszel|||Day 2||||0.1001
74040300|NCT00764478|147632772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0011
74040301|NCT00764478|147632772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0011
74040302|NCT00764478|147632772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0194|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0194
74040303|NCT00764478|147632772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0841|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0841
74040304|NCT00764478|147632772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4858|||||||Cochran-Mantel-Haenszel|||Day 14||||0.4858
73879079|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.84||0.0049|TWO_SIDED|95.0|-4.04|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.73|-4.04|0.0049
73879080|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.0008|TWO_SIDED|95.0|-4.48|-1.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.18|-4.48|0.0008
73879081|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.84||0.0428|TWO_SIDED|95.0|-3.36|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.06|-3.36|0.0428
73879082|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0004|TWO_SIDED|95.0|-4.65|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.34|-4.65|0.0004
74040305|NCT00764478|147632772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2496|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2496
74040306|NCT00764478|147632773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2912|||||||Cochran-Mantel-Haenszel|||||||0.2912
74040307|NCT00764478|147632773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1151|||||||Cochran-Mantel-Haenszel|||||||0.1151
74040308|NCT00764478|147632775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||ANCOVA|||Day 7||||0.0019
74040309|NCT00764478|147632775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||ANCOVA|||Day 7||||0.0045
74040310|NCT00764478|147632775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0112|||||||ANCOVA|||Day 21||||0.0112
74040311|NCT00764478|147632775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|||||||ANCOVA|||Day 21||||0.0021
74040312|NCT00764478|147632776|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.4|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2||-0.1|-0.4|<0.0001
74040313|NCT00764478|147632776|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.0076|TWO_SIDED|95.0|-0.3|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2||-0.1|-0.3|0.0076
74040314|NCT00764478|147632776|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||-0.2|-0.6|0.0004
74040315|NCT00764478|147632776|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.5|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4||-0.1|-0.5|0.0040
74040316|NCT00764478|147632776|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0061|TWO_SIDED|95.0|-0.6|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.1|-0.6|0.0061
74009571|NCT01133379|147570250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|2.723||0.763|TWO_SIDED|95.0|-6.2|4.55||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.55|-6.20|0.763
74009572|NCT01133379|147570251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|2.856||0.488|TWO_SIDED|95.0|-7.62|3.66||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||3.66|-7.62|0.488
74009573|NCT01133379|147570251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.854||0.311|TWO_SIDED|95.0|-8.54|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups||2.73|-8.54|0.311
74009574|NCT01133379|147570252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|3.478||0.604|TWO_SIDED|95.0|-8.68|5.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.06|-8.68|0.604
74009575|NCT01133379|147570252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|3.477||0.583|TWO_SIDED|95.0|-4.95|8.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.78|-4.95|0.583
74009576|NCT01133379|147570253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|3.61||0.847|TWO_SIDED|95.0|-7.83|6.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.43|-7.83|0.847
74009577|NCT01133379|147570253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|3.61||0.708|TWO_SIDED|95.0|-5.77|8.48||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.48|-5.77|0.708
74009578|NCT01133379|147570254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|2.678||0.36|TWO_SIDED|95.0|-7.75|2.83||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.83|-7.75|0.360
74009579|NCT01133379|147570254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|2.679||0.149|TWO_SIDED|95.0|-9.17|1.41||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.41|-9.17|0.149
73887952|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|43.6|||<|0.0001|TWO_SIDED|95.0|26.6|60.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||60.7|26.6|<0.0001
74009580|NCT01133379|147570255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.61|STANDARD_ERROR_OF_MEAN|3.235||0.421|TWO_SIDED|95.0|-9.0|3.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||3.78|-9.00|0.421
74009581|NCT01133379|147570255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|STANDARD_ERROR_OF_MEAN|3.235||0.26|TWO_SIDED|95.0|-10.0|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.73|-10.0|0.260
74009582|NCT01133379|147570256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|3.601||0.989|TWO_SIDED|95.0|-7.16|7.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||7.06|-7.16|0.989
74009583|NCT01133379|147570256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|3.599||0.721|TWO_SIDED|95.0|-8.39|5.82||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.82|-8.39|0.721
73879083|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|-0.84||1e-05|TWO_SIDED|95.0|-4.88|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.58|-4.88|0.00001
73879084|NCT03192176|147297609|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|95.0|-5.73|-2.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.37|-5.73|<0.0001
73879085|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0225|TWO_SIDED|95.0|-3.64|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.28|-3.64|0.0225
74009584|NCT01133379|147570257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|STANDARD_ERROR_OF_MEAN|3.69||0.743|TWO_SIDED|95.0|-8.5|6.07||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.07|-8.50|0.743
74009585|NCT01133379|147570257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|3.688||0.928|TWO_SIDED|95.0|-7.61|6.95||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.95|-7.61|0.928
74009586|NCT01133379|147570258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.369||0.683|TWO_SIDED|95.0|-3.71|5.65||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.65|-3.71|0.683
74009587|NCT01133379|147570258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|2.371||0.914|TWO_SIDED|95.0|-4.94|4.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.42|-4.94|0.914
74009588|NCT01133379|147570259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.19|STANDARD_ERROR_OF_MEAN|2.994||0.04|TWO_SIDED|95.0|-12.1|-0.27||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.27|-12.1|0.040
74009589|NCT01133379|147570259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|2.997||0.043|TWO_SIDED|95.0|-12.0|-0.18||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.18|-12.0|0.043
74040317|NCT00764478|147632776|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0031|TWO_SIDED|95.0|-0.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.1|-0.6|0.0031
74040318|NCT00764478|147632776|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1086|TWO_SIDED|95.0|-0.5|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.1|-0.5|0.1086
74040319|NCT00764478|147632776|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.0376|TWO_SIDED|95.0|-0.6|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.0|-0.6|0.0376
74040320|NCT00764478|147632777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|||||||ANCOVA|||Day 2||||0.0005
73879086|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.0008|TWO_SIDED|95.0|-4.49|-1.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.19|-4.49|0.0008
73879087|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.84||0.0003|TWO_SIDED|95.0|-4.7|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.42|-4.70|0.0003
73879088|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1168|TWO_SIDED|95.0|-2.8|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.31|-2.80|0.1168
73879089|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.79||0.0012|TWO_SIDED|95.0|-4.15|-1.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.03|-4.15|0.0012
73879090|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.79||0.0002|TWO_SIDED|95.0|-4.54|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.42|-4.54|0.0002
73887953|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|68.4|||<|0.0001|TWO_SIDED|95.0|51.3|85.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||85.4|51.3|<0.0001
74009590|NCT01133379|147570260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|3.522||0.511|TWO_SIDED|95.0|-9.27|4.64||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.64|-9.27|0.511
74009591|NCT01133379|147570260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|STANDARD_ERROR_OF_MEAN|3.526||0.25|TWO_SIDED|95.0|-11.0|2.89||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.89|-11.0|0.250
74009592|NCT01133379|147570261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.41|STANDARD_ERROR_OF_MEAN|3.684||0.233|TWO_SIDED|95.0|-11.7|2.86||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.86|-11.7|0.233
74009593|NCT01133379|147570261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.84|STANDARD_ERROR_OF_MEAN|3.687||0.115|TWO_SIDED|95.0|-13.1|1.44||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.44|-13.1|0.115
74009594|NCT05470465|147570263|SUPERIORITY||Mean Difference (Final Values)|-6.5|||<|0.001|ONE_SIDED|97.5||-3.1||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.1||<0.001
74009595|NCT05470465|147570263|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.001|ONE_SIDED|97.5||-2.1||To demonstrate an effect of oxycodone with escitalopram compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and escitalopram compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.1||0.001
74009596|NCT05470465|147570264|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.002|ONE_SIDED|97.5||-2.1||To demonstrate an effect of paroxetine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.1||0.002
74009597|NCT05470465|147570264|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.003|ONE_SIDED|97.5||-2.5||To demonstrate an effect of escitalopram compared to placebo, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.5||0.003
74040321|NCT00764478|147632777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||ANCOVA|||Day 2||||0.0026
74040322|NCT00764478|147632777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|||||||ANCOVA|||Day 4||||0.0007
74040323|NCT00764478|147632777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||ANCOVA|||Day 4||||0.0002
74040324|NCT00764478|147632777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0387|||||||ANCOVA|||Day 7||||0.0387
74040325|NCT00764478|147632777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0059|||||||ANCOVA|||Day 7||||0.0059
74040326|NCT00764478|147632777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.311|||||||ANCOVA|||Day 14||||0.3110
74040327|NCT00764478|147632777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0613|||||||ANCOVA|||Day 14||||0.0613
74040328|NCT00764478|147632777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064|||||||ANCOVA|||Day 21||||0.0640
74040329|NCT00764478|147632777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0139|||||||ANCOVA|||Day 21||||0.0139
74040330|NCT00764478|147632778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9708|||||||ANCOVA|||Day 2||||0.9708
74040331|NCT00764478|147632778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7891|||||||ANCOVA|||Day 2||||0.7891
74040332|NCT00764478|147632778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5222|||||||ANCOVA|||Day 4||||0.5222
74040333|NCT00764478|147632778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8686|||||||ANCOVA|||Day 4||||0.8686
74009598|NCT05470465|147570265|SUPERIORITY||Mean Difference (Final Values)|-7.1|||<|0.001|ONE_SIDED|97.5||-4.1||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and paroxetine compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 6 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-4.1||<0.001
74009599|NCT05470465|147570265|SUPERIORITY||Mean Difference (Final Values)|-5.6|||<|0.001|ONE_SIDED|97.5||-2.6||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and escitalopram compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and escitalopram compared to oxycodone and placebo at day 6 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.6||<0.001
74040334|NCT00764478|147632778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0696|||||||ANCOVA|||Day 7||||0.0696
74040335|NCT00764478|147632778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||ANCOVA|||Day 7||||0.0049
74040336|NCT00764478|147632778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196|||||||ANCOVA|||Day 14||||0.0196
74040337|NCT00764478|147632778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0032|||||||ANCOVA|||Day 14||||0.0032
74040338|NCT00764478|147632778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||ANCOVA|||Day 21||||0.0061
74040339|NCT00764478|147632778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|||||||ANCOVA|||Day 21||||0.0012
74040340|NCT00764478|147632779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0147
74040341|NCT00764478|147632779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0720
74040342|NCT00764478|147632779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1213|||||||Cochran-Mantel-Haenszel|||Day 4||||0.1213
74040343|NCT00764478|147632779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0588|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0588
74040344|NCT00764478|147632779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0200
74040345|NCT00764478|147632779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0017
74040346|NCT00764478|147632779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2401|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2401
74040347|NCT00764478|147632779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0009
74040348|NCT00764478|147632779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0525|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0525
74040349|NCT00764478|147632779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0025
74040350|NCT00764478|147632780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0377|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0377
74040351|NCT00764478|147632780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0771|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0771
74040352|NCT00764478|147632780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1264|||||||Cochran-Mantel-Haenszel|||Day 4||||0.1264
74040353|NCT00764478|147632780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0280
74040354|NCT00764478|147632780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0583|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0583
74040355|NCT00764478|147632780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0021
74040356|NCT00764478|147632780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0866
74040357|NCT00764478|147632780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0048|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0048
74040358|NCT00764478|147632780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0147
74040359|NCT00764478|147632780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0030
74040360|NCT00764478|147632781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0104
74040361|NCT00764478|147632781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0005
74040362|NCT00764478|147632781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0692
74040363|NCT00764478|147632781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0128|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0128
74040364|NCT00764478|147632781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0809|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0809
74040365|NCT00764478|147632781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0260
74040366|NCT00764478|147632781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2576|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2576
74040367|NCT00764478|147632781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0077|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0077
74040368|NCT00764478|147632781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.396|||||||Cochran-Mantel-Haenszel|||Day 21||||0.3960
74040369|NCT00764478|147632781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0141|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0141
74040370|NCT00764478|147632782|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-3.0|STANDARD_ERROR_OF_MEAN|1.06||0.0056|TWO_SIDED|95.0|-5.1|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.9|-5.1|0.0056
74040371|NCT00764478|147632782|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.9|STANDARD_ERROR_OF_MEAN|1.08||0.0068|TWO_SIDED|95.0|-5.0|-0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.8|-5.0|0.0068
74040372|NCT00764478|147632782|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.33||0.0743|TWO_SIDED|95.0|-5.0|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.2|-5.0|0.0743
73879091|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-5.44|-2.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.28|-5.44|<0.0001
73879092|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.8||0.0134|TWO_SIDED|95.0|-3.58|-0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.42|-3.58|0.0134
73879093|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0057|TWO_SIDED|95.0|-3.76|-0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.65|-3.76|0.0057
74040373|NCT00764478|147632782|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.2|STANDARD_ERROR_OF_MEAN|1.35||0.0177|TWO_SIDED|95.0|-5.9|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.6|-5.9|0.0177
73879094|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.79||0.0016|TWO_SIDED|95.0|-4.06|-0.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.96|-4.06|0.0016
73887954|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|54.3|||<|0.0001|TWO_SIDED|95.0|37.3|71.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.4|37.3|<0.0001
74009600|NCT05470465|147570266|SUPERIORITY||Mean Difference (Final Values)|-10.1|||<|0.001|ONE_SIDED|97.5||-5.9||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and paroxetine compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 12 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-5.9||<0.001
74009601|NCT05470465|147570266|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.003|ONE_SIDED|97.5||-2.7||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and escitalopram compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 12 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.7||0.003
74009602|NCT05470465|147570267|SUPERIORITY||Mean Difference (Final Values)|-11.6|||<|0.001|ONE_SIDED|97.5||-6.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo at day 5 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-6.5||<0.001
74009603|NCT05470465|147570267|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.001|ONE_SIDED|97.5||-9.0||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of escitalopram compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo at day 5 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-9.0||<0.001
74040374|NCT00764478|147632782|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.8|STANDARD_ERROR_OF_MEAN|1.41||0.0081|TWO_SIDED|95.0|-6.6|-1.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-1.0|-6.6|0.0081
74040375|NCT00764478|147632782|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.2|STANDARD_ERROR_OF_MEAN|1.43||0.0247|TWO_SIDED|95.0|-6.1|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.4|-6.1|0.0247
74040376|NCT00764478|147632783|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9808|TWO_SIDED|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.6|-0.6|0.9808
74040377|NCT00764478|147632783|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.283|TWO_SIDED|95.0|-0.9|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.3|-0.9|0.2830
74092535|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74009604|NCT05470465|147570268|SUPERIORITY||Mean Difference (Final Values)|-14.1|||<|0.001|ONE_SIDED|97.5||-8.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo at day 11 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-8.5||<0.001
74009605|NCT05470465|147570268|SUPERIORITY||Mean Difference (Final Values)|-9.5|||<|0.001|ONE_SIDED|97.5||-3.8||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of escitalopram compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo at day 11 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.8||<0.001
74009606|NCT01488279|147570289|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|480.8||0.983|TWO_SIDED|95.0|-1147.6|1126.0|||ANOVA|||2X2 crossover design with baseline values. To compare the means between Sitagliptin and Placebo, a sequential three step testing process used. The results of the third step, the direct treatment comparisons are presented.||1126.0|-1147.6|.983
74009607|NCT01488279|147570292|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|1.935||0.997|TWO_SIDED|95.0|-4.585|4.568|||ANOVA|||||4.568|-4.585|.997
74009608|NCT01488279|147570293|SUPERIORITY||Mean Difference (Net)|-38.9|STANDARD_ERROR_OF_MEAN|49.9||0.46|TWO_SIDED|95.0|-156.9|79.0|||ANOVA|||||79.0|-156.9|.460
74009609|NCT03861936|147570301|SUPERIORITY||Percentage Difference|68.8|||<|0.0001|TWO_SIDED|95.0|54.5|83.1||P-values for between-treatment comparisons are based on Cochran-Mantel-Haenszel (CMH) model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||83.1|54.5|<.0001
74009610|NCT03861936|147570301|SUPERIORITY||Percentage Difference|69.6|||<|0.0001|TWO_SIDED|95.0|55.1|84.0||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||84.0|55.1|<.0001
74009611|NCT03861936|147570307|SUPERIORITY||Percentage Difference|48.4|||<|0.0001|TWO_SIDED|95.0|33.1|63.7||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||63.7|33.1|<.0001
74009612|NCT03861936|147570307|SUPERIORITY||Percentage Difference|45.7|||<|0.0001|TWO_SIDED|95.0|29.5|61.8||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||61.8|29.5|<.0001
74009613|NCT03861936|147570308|SUPERIORITY||Percentage Difference|55.2|||<|0.0001|TWO_SIDED|95.0|39.6|70.8||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||70.8|39.6|<.0001
74009614|NCT03861936|147570308|SUPERIORITY||Percentage Difference|60.9|||<|0.0001|TWO_SIDED|95.0|45.1|76.7||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||76.7|45.1|<.0001
74009615|NCT03861936|147570309|SUPERIORITY||Percentage Difference|54.2|||<|0.0001|TWO_SIDED|95.0|37.9|70.5||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||70.5|37.9|<.0001
74009616|NCT03861936|147570309|SUPERIORITY||Percentage Difference|47.8|||<|0.0001|TWO_SIDED|95.0|30.1|65.6||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||65.6|30.1|<.0001
74009617|NCT03861936|147570310|SUPERIORITY||Percentage Difference|68.8|||<|0.0001|TWO_SIDED|95.0|54.5|83.1||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||83.1|54.5|<.0001
74009618|NCT03861936|147570310|SUPERIORITY||Percentage Difference|52.2|||<|0.0001|TWO_SIDED|95.0|34.8|69.6||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||69.6|34.8|<.0001
74009619|NCT03861936|147570311|SUPERIORITY||Least Squares (LS) Mean Difference|-5.82|STANDARD_ERROR_OF_MEAN|0.647|<|0.0001|TWO_SIDED|95.0|-7.1|-4.54||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-4.54|-7.10|<.0001
74009620|NCT03861936|147570311|SUPERIORITY||LS Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|0.678|<|0.0001|TWO_SIDED|95.0|-7.15|-4.47||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-4.47|-7.15|<.0001
74009621|NCT03861936|147570312|SUPERIORITY||LS Mean Difference|-7.63|STANDARD_ERROR_OF_MEAN|0.756|<|0.0001|TWO_SIDED|95.0|-9.12|-6.13||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-6.13|-9.12|<.0001
74040378|NCT00764478|147632783|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.32||0.9751|TWO_SIDED|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.6|-0.6|0.9751
74009622|NCT03861936|147570312|SUPERIORITY||LS Mean Difference|-8.26|STANDARD_ERROR_OF_MEAN|0.793|<|0.0001|TWO_SIDED|95.0|-9.83|-6.69||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-6.69|-9.83|<.0001
74009623|NCT01846728|147570319|OTHER|||||||0.84||||||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations|t-test, 2 sided|||||||0.84
74040379|NCT00764478|147632783|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.33||0.7879|TWO_SIDED|95.0|-0.6|0.7|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.7|-0.6|0.7879
74009624|NCT01846728|147570320|OTHER|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.66
74009625|NCT01846728|147570321|OTHER|Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||||0.92|||||||t-test, 2 sided|||||||0.92
74009626|NCT01846728|147570322|OTHER|||||||0.98|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.98
74009627|NCT01846728|147570323|OTHER|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.66
74040380|NCT00764478|147632783|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9654|TWO_SIDED|95.0|-0.8|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.7|-0.8|0.9654
74009628|NCT02446314|147570329|SUPERIORITY||||||=|0.04|||||||Linear Mixed Model / Baseline Covariate|||||||= .04
74009629|NCT02446314|147570330|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
74009630|NCT02446314|147570331|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
74009631|NCT02446314|147570332|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
74009632|NCT02446314|147570333|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
74009633|NCT00701090|147570345|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%, i.e., Sitagliptin was declared non-inferior to glimepiride if the upper limit of the two-sided 95% confidence interval for the between group difference (sitagliptin minus glimepiride) was less than 0.4%|Mean Difference (Net)|0.07|STANDARD_DEVIATION|0.7|||TWO_SIDED|95.0|-0.03|0.16|||||ANCOVA model with terms: treatment, country, and baseline HbA1c.|||0.16|-0.03|
74009634|NCT00701090|147570346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_DEVIATION|28.8|||TWO_SIDED|95.0|-0.9|6.7|||||ANCOVA model terms: treatment, country, and baseline.|||6.7|-0.9|
74009635|NCT00701090|147570347|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.0|||<|0.001|TWO_SIDED|95.0|-19.3|-10.9|||Miettinen &Nurminen method||Miettinen \&Nurminen method was used for the 95% confidence interval|||-10.9|-19.3|<0.001
74009636|NCT00701090|147570348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|2.9|<|0.001|TWO_SIDED|95.0|-2.3|-1.6|||ANCOVA|Model terms: treatment, country, and baseline.|ANCOVA model terms: treatment, country, and baseline.|||-1.6|-2.3|<0.001
74009637|NCT00701090|147570349|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.47|0.9|||||The parameter estimate and 95% CI represent the odds of having A1C \<7.0% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.|||0.90|0.47|
74009638|NCT00701090|147570350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.47|0.95|||||The parameter estimate and 95% CI represent the odds of having A1C \<6.5% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.|||0.95|0.47|
74009639|NCT00324753|147570367|SUPERIORITY|||||||0.005||||||p-value based on a test of any treatment difference by site.|Mixed Models Analysis|The model was run using the xtlogit command in Stata and was adjusted for all of the reported baseline characteristics.||||||.005
74040381|NCT00764478|147632783|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.39||0.3917|TWO_SIDED|95.0|-0.4|1.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||1.1|-0.4|0.3917
73887955|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|53.0|||<|0.0001|TWO_SIDED|95.0|36.0|70.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||70.1|36.0|<0.0001
74040382|NCT00764478|147632784|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.41||0.012|TWO_SIDED|95.0|-1.8|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.2|-1.8|0.0120
74009640|NCT02247960|147570402|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
74009641|NCT04305275|147570434|SUPERIORITY||Least Squares (LS) Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.533||0.0491|TWO_SIDED|95.0|-2.14|0.0|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||||0.00|-2.14|0.0491
74009642|NCT04305275|147570435|SUPERIORITY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.398||0.0468|TWO_SIDED|95.0|-1.6|-0.01|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||-0.01|-1.60|0.0468
74009643|NCT04305275|147570435|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.467||0.3124|TWO_SIDED|95.0|-1.41|0.46|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||0.46|-1.41|0.3124
74009644|NCT04305275|147570435|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.605||0.5148|TWO_SIDED|95.0|-1.61|0.81|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||0.81|-1.61|0.5148
74009645|NCT04305275|147570435|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.59||0.6452|TWO_SIDED|95.0|-1.45|0.91|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||0.91|-1.45|0.6452
74009646|NCT04305275|147570435|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.482||0.1171|TWO_SIDED|95.0|-1.73|0.2|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||0.20|-1.73|0.1171
74009647|NCT04305275|147570435|SUPERIORITY||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.557||0.2724|TWO_SIDED|95.0|-0.5|1.73|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||1.73|-0.50|0.2724
74009648|NCT04305275|147570436|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.658||0.8784|TWO_SIDED|95.0|-1.42|1.21|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||1.21|-1.42|0.8784
74009649|NCT04305275|147570436|SUPERIORITY||LS mean difference|0.93|STANDARD_ERROR_OF_MEAN|0.687||0.1795|TWO_SIDED|95.0|-0.44|2.3|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||2.30|-0.44|0.1795
74009650|NCT04305275|147570436|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.829||0.5588|TWO_SIDED|95.0|-2.15|1.17|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||1.17|-2.15|0.5588
74009651|NCT04305275|147570436|SUPERIORITY||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.796||0.5036|TWO_SIDED|95.0|-1.06|2.13|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||2.13|-1.06|0.5036
74009652|NCT04305275|147570436|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.736||0.6636|TWO_SIDED|95.0|-1.15|1.79|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||1.79|-1.15|0.6636
74009653|NCT04305275|147570436|SUPERIORITY||LS mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.756||0.3999|TWO_SIDED|95.0|-0.87|2.15|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||2.15|-0.87|0.3999
74009654|NCT04305275|147570436|SUPERIORITY||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|0.776||0.3933|TWO_SIDED|95.0|-0.88|2.22|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||2.22|-0.88|0.3933
74009655|NCT04305275|147570437|SUPERIORITY||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.167||0.0193|TWO_SIDED|95.0|-5.14|-0.47|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||-0.47|-5.14|0.0193
74009656|NCT04305275|147570437|SUPERIORITY||LS mean difference|-2.95|STANDARD_ERROR_OF_MEAN|1.277||0.0243|TWO_SIDED|95.0|-5.51|-0.4|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15||-0.40|-5.51|0.0243
74009657|NCT04305275|147570437|SUPERIORITY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.209||0.0385|TWO_SIDED|95.0|-4.98|-0.14|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||-0.14|-4.98|0.0385
74009658|NCT04305275|147570437|SUPERIORITY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|1.221||0.2682|TWO_SIDED|95.0|-3.81|1.08|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||1.08|-3.81|0.2682
74009659|NCT04305275|147570437|SUPERIORITY||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|1.233||0.3649|TWO_SIDED|95.0|-1.34|3.59|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||3.59|-1.34|0.3649
74009660|NCT04305275|147570438|SUPERIORITY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|1.078||0.2478|TWO_SIDED|95.0|-3.41|0.9|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||0.90|-3.41|0.2478
74040383|NCT00764478|147632784|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.42||0.0011|TWO_SIDED|95.0|-2.2|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.5|-2.2|0.0011
74009661|NCT04305275|147570438|SUPERIORITY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|1.192||0.4486|TWO_SIDED|95.0|-3.29|1.47|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||1.47|-3.29|0.4486
74009662|NCT04305275|147570438|SUPERIORITY||LS mean difference|-1.52|STANDARD_ERROR_OF_MEAN|1.352||0.2662|TWO_SIDED|95.0|-4.22|1.19|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||1.19|-4.22|0.2662
74009663|NCT04305275|147570438|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.282||0.9965|TWO_SIDED|95.0|-2.56|2.57|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||2.57|-2.56|0.9965
74009664|NCT04305275|147570438|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|1.222||0.8437|TWO_SIDED|95.0|-2.68|2.2|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||2.20|-2.68|0.8437
74009665|NCT04305275|147570438|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|1.232||0.796|TWO_SIDED|95.0|-2.78|2.14|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||2.14|-2.78|0.7960
74040384|NCT00764478|147632784|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6885|TWO_SIDED|95.0|-1.2|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.8|-1.2|0.6885
74009666|NCT04305275|147570438|SUPERIORITY||LS mean difference|2.28|STANDARD_ERROR_OF_MEAN|1.119||0.0456|TWO_SIDED|95.0|0.05|4.52|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||4.52|0.05|0.0456
74009667|NCT01022242|147570450|SUPERIORITY_OR_OTHER|||||||0.8861|||||||ANCOVA|||||||0.8861
74040385|NCT00764478|147632784|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.52||0.0398|TWO_SIDED|95.0|-2.1|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.1|-2.1|0.0398
73879095|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.79||0.0843|TWO_SIDED|95.0|-2.94|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.19|-2.94|0.0843
74009668|NCT01536951|147570457|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|0.239|||||TWO_SIDED|90.0|-1.65|2.12|||||LS mean difference (LY3009104 minus placebo) of change in QTcP 1 h postdose analyzed using analysis of covariance (ANCOVA) model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.12|-1.65|
74009669|NCT01536951|147570457|SUPERIORITY_OR_OTHER||LS mean difference|1.81|||||TWO_SIDED|90.0|-0.079|3.69|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 1.5 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.69|-0.0790|
74009670|NCT01536951|147570457|SUPERIORITY_OR_OTHER||LS Mean Difference|1.44|||||TWO_SIDED|90.0|-0.446|3.32|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.32|-0.446|
74009671|NCT01536951|147570457|SUPERIORITY_OR_OTHER||LS mean difference|0.468|||||TWO_SIDED|90.0|-1.42|2.35|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 3 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.35|-1.42|
74009672|NCT01536951|147570457|SUPERIORITY_OR_OTHER||LS mean difference|0.702|||||TWO_SIDED|90.0|-1.18|2.59|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.59|-1.18|
74009673|NCT01536951|147570457|SUPERIORITY_OR_OTHER||LS mean difference|-0.788|||||TWO_SIDED|90.0|-2.68|1.1|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 6 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||1.10|-2.68|
73879096|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.8||0.0035|TWO_SIDED|95.0|-3.9|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.77|-3.90|0.0035
74009674|NCT01536951|147570457|SUPERIORITY_OR_OTHER||LS mean difference|1.71|||||TWO_SIDED|90.0|-0.182|3.6|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 12 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.60|-0.182|
74009675|NCT01536951|147570457|SUPERIORITY_OR_OTHER||LS mean difference|0.963|||||TWO_SIDED|90.0|-0.921|2.85|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 24 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.85|-0.921|
74009676|NCT01536951|147570457|SUPERIORITY_OR_OTHER||LS mean difference|12.3|||||TWO_SIDED|90.0|10.0|14.5|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 1 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||14.5|10.0|
74009677|NCT01536951|147570457|SUPERIORITY_OR_OTHER||LS mean difference|11.0|||||TWO_SIDED|90.0|8.74|13.3|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||13.3|8.74|
74009678|NCT01536951|147570457|SUPERIORITY_OR_OTHER||LS mean difference|11.1|||||TWO_SIDED|90.0|8.87|13.4|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||13.4|8.87|
74009679|NCT01843972|147570461|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|97.88|STANDARD_DEVIATION|24.8|||TWO_SIDED|90.0|79.963|119.809|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||119.809|79.963|
74009680|NCT01843972|147570461|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|111.2|STANDARD_DEVIATION|24.7|||TWO_SIDED|90.0|88.596|139.576|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||139.576|88.596|
74040386|NCT00764478|147632784|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.51||0.0258|TWO_SIDED|95.0|-2.1|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.1|-2.1|0.0258
74040387|NCT00764478|147632784|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.5|STANDARD_ERROR_OF_MEAN|0.51||0.0031|TWO_SIDED|95.0|-2.5|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.5|-2.5|0.0031
74040388|NCT00764478|147632785|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.9|STANDARD_ERROR_OF_MEAN|0.64||0.0033|TWO_SIDED|95.0|-3.2|-0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.6|-3.2|0.0033
74040389|NCT00764478|147632785|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.65||0.0622|TWO_SIDED|95.0|-2.5|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.1|-2.5|0.0622
74040390|NCT00764478|147632785|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0083|TWO_SIDED|95.0|-3.6|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||-0.5|-3.6|0.0083
74040391|NCT00764478|147632785|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0064|TWO_SIDED|95.0|-3.8|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.6|-3.8|0.0064
74040392|NCT00764478|147632785|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.6|STANDARD_ERROR_OF_MEAN|0.84||0.0022|TWO_SIDED|95.0|-4.3|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.9|-4.3|0.0022
74040393|NCT00764478|147632785|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0196|TWO_SIDED|95.0|-3.7|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-3.7|0.0196
74040394|NCT00764478|147632786|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1883|TWO_SIDED|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.3|-1.3|0.1883
74040395|NCT00764478|147632786|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.1684|TWO_SIDED|95.0|-1.3|0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.2|-1.3|0.1684
74040396|NCT00764478|147632786|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.9522|TWO_SIDED|95.0|-0.9|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-0.9|0.9522
74040397|NCT00764478|147632786|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.47||0.0514|TWO_SIDED|95.0|-1.8|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.0|-1.8|0.0514
74040398|NCT00764478|147632786|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.47||0.0531|TWO_SIDED|95.0|-1.8|0.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.0|-1.8|0.0531
74040399|NCT00764478|147632786|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.3|STANDARD_ERROR_OF_MEAN|0.48||0.0078|TWO_SIDED|95.0|-2.2|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-2.2|0.0078
74009681|NCT01843972|147570462|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|101.31|STANDARD_DEVIATION|28.2|||TWO_SIDED|90.0|80.593|127.351|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||127.351|80.593|
73879097|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.66|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.52|-4.66|0.0001
74009682|NCT01843972|147570462|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|92.69|STANDARD_DEVIATION|33.0|||TWO_SIDED|90.0|68.662|125.119|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||125.119|68.662|
74009683|NCT01843972|147570463|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|1.0233|||||TWO_SIDED|95.0|0.8265|1.2201|||Regression, Linear|||||1.2201|0.8265|
74040400|NCT00764478|147632787|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.7746|TWO_SIDED|95.0|-0.7|0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.5|-0.7|0.7746
74040401|NCT00764478|147632787|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2754|TWO_SIDED|95.0|-1.0|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.3|-1.0|0.2754
74040402|NCT00764478|147632787|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.34||0.9109|TWO_SIDED|95.0|-0.6|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.7|-0.6|0.9109
74040403|NCT00764478|147632787|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.7295|TWO_SIDED|95.0|-0.6|0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.8|-0.6|0.7295
74040404|NCT00764478|147632787|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.98|TWO_SIDED|95.0|-0.7|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.8|-0.7|0.9800
74040405|NCT00764478|147632787|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.38||0.5122|TWO_SIDED|95.0|-0.5|1.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||1.0|-0.5|0.5122
74040406|NCT00764478|147632788|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.2191|TWO_SIDED|95.0|-0.9|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-0.9|0.2191
74040407|NCT00764478|147632788|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0589|TWO_SIDED|95.0|-1.1|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.0|-1.1|0.0589
74040408|NCT00764478|147632788|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.36||0.3683|TWO_SIDED|95.0|-1.0|0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.0|0.3683
74040409|NCT00764478|147632788|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.37||0.0982|TWO_SIDED|95.0|-1.3|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.1|-1.3|0.0982
74040410|NCT00764478|147632788|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.1969|TWO_SIDED|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.3|-1.3|0.1969
74040411|NCT00764478|147632788|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.5615|TWO_SIDED|95.0|-1.0|0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||0.5|-1.0|0.5615
74040412|NCT00764478|147632789|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.33||0.0101|TWO_SIDED|95.0|-1.5|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.2|-1.5|0.0101
74040413|NCT00764478|147632789|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0146|TWO_SIDED|95.0|-1.5|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.2|-1.5|0.0146
74040414|NCT00764478|147632789|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.39||0.0861|TWO_SIDED|95.0|-1.4|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.1|-1.4|0.0861
74040415|NCT00764478|147632789|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0342|TWO_SIDED|95.0|-1.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.1|-1.6|0.0342
74040416|NCT00764478|147632789|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0037|TWO_SIDED|95.0|-2.0|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.4|-2.0|0.0037
74009684|NCT01843972|147570464|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|0.9686|||||TWO_SIDED|95.0|0.8107|1.1266|||Regression, Linear|||Dose proportionality of BI 691751 was explored using a power model (regression model applied to log-transformed data).||1.1266|0.8107|
74009685|NCT01843972|147570465|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|95.48|STANDARD_DEVIATION|30.8|||TWO_SIDED|90.0|74.414|122.511|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||122.511|74.414|
74009686|NCT01843972|147570465|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|109.8|STANDARD_DEVIATION|28.8|||TWO_SIDED|90.0|84.376|142.894|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||142.894|84.376|
74009687|NCT01843972|147570465|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|1.0312|||||TWO_SIDED|95.0|0.833|1.179|||Regression, Linear|||||1.1790|0.833|
74009688|NCT00382018|147570474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.69|1.47|||Log Rank|||Hazard Ration of overall survival compared Arm C2 to Arm C1.||1.47|0.69|0.98
74009689|NCT00382018|147570475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.64|TWO_SIDED|95.0|0.64|1.32|||Log Rank|||Hazard Ratio of progression free survival compared Arm C2 to Arm C1||1.32|0.64|0.64
74009690|NCT03805750|147570485|OTHER|||||||0.52|||||||Regression, Logistic|||||||0.52
74009691|NCT00789880|147570487|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP expression in lesional skin of AD participants differs by treatment group.||||0.7
74009692|NCT00789880|147570487|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.12
74009693|NCT00789880|147570488|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.3
74009694|NCT00789880|147570489|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.4
74009695|NCT00789880|147570489|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||0.2
74009696|NCT00789880|147570490|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in lesional skin of AD participants differs by treatment group.||||0.8
74009697|NCT00789880|147570490|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.2
74009698|NCT00789880|147570491|SUPERIORITY_OR_OTHER|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.4
74009699|NCT00789880|147570492|SUPERIORITY_OR_OTHER|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.4
74040417|NCT00764478|147632789|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.0096|TWO_SIDED|95.0|-1.9|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-1.9|0.0096
74040418|NCT00764478|147632790|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.32||0.0019|TWO_SIDED|95.0|-1.7|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.4|-1.7|0.0019
74040419|NCT00764478|147632790|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.33||0.0791|TWO_SIDED|95.0|-1.2|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.1|-1.2|0.0791
74009700|NCT00789880|147570492|SUPERIORITY_OR_OTHER|||||||1||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||1.0
74009701|NCT00789880|147570493|SUPERIORITY_OR_OTHER|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of AD participants differs by treatment group.||||0.2
74009702|NCT00789880|147570493|SUPERIORITY_OR_OTHER|||||||0.5||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.5
74009703|NCT00789880|147570494|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.7
74009704|NCT00789880|147570495|SUPERIORITY_OR_OTHER|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.2
74009705|NCT00789880|147570495|SUPERIORITY_OR_OTHER|||||||0.3||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||0.3
74040420|NCT00764478|147632790|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.36||0.0006|TWO_SIDED|95.0|-2.0|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||-0.5|-2.0|0.0006
74040421|NCT00764478|147632790|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.37||0.0123|TWO_SIDED|95.0|-1.6|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.2|-1.6|0.0123
74040422|NCT00764478|147632790|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.0054|TWO_SIDED|95.0|-2.0|-0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.3|-2.0|0.0054
74040423|NCT00764478|147632790|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.41||0.035|TWO_SIDED|95.0|-1.7|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.1|-1.7|0.0350
74009706|NCT02568475|147570514|EQUIVALENCE|Continuous scale: score compares results before and after intervention without a cut parameter.|Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.74||0.046|TWO_SIDED|95.0|0.059|7.12|||t-test, 2 sided|||||7.12|0.059|0.046
74009707|NCT02568475|147570515|OTHER|This is a continuous scale with no clinical cut score/value. We tested mean differences between the two groups.|Mean Difference (Final Values)|6.78||||0.001|TWO_SIDED|95.0|2.9|10.6|||t-test, 2 sided|||||10.6|2.9|0.001
74009708|NCT00493220|147570519|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|111.79|||||TWO_SIDED|90.0|108.57|115.12|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||115.12|108.57|
74009709|NCT00493220|147570519|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|60.81|||||TWO_SIDED|90.0|59.06|62.62|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||62.62|59.06|
74009710|NCT00493220|147570519|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|54.4|||||TWO_SIDED|90.0|52.82|56.01|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||56.01|52.82|
74009711|NCT00493220|147570520|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0|||<|0.01|TWO_SIDED|90.0|-1.25|-0.75|||Wilcoxon signed-rank test||HYLENEX SC minus Placebo SC|||-0.75|-1.25|<0.01
74009712|NCT00493220|147570520|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.52|||<|0.01|TWO_SIDED|90.0|1.27|1.71|||Wilcoxon signed-rank test||Placebo SC minus Intravenous|||1.71|1.27|<0.01
74009713|NCT00493220|147570520|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.52|||<|0.01|TWO_SIDED|90.0|2.26|2.76|||Wilcoxon signed-rank test||Placebo SC minus Intravenous|||2.76|2.26|<0.01
74009714|NCT00493220|147570521|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.99|||||TWO_SIDED|90.0|98.95|105.12|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||105.12|98.95|
74040424|NCT01369212|147632792|SUPERIORITY|||||||0.72|||||||Wald test|Proportion with HBsAg loss at week 240 in each group is estimated by Kaplan-Meier and then equality of proportion is tested using Wald test.||||||0.72
74040425|NCT01369212|147632793|SUPERIORITY|||||||0.09||||||The cumulative percentages with HBsAg loss at week 192 were estimated using Kaplan-Meier method and then the equality is tested using Wald test.|Wald Test|||||||0.09
74040426|NCT01369212|147632794|SUPERIORITY|||||||0.46|||||||Fisher Exact|||||||0.46
74040427|NCT01369212|147632795|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
74040428|NCT01369212|147632796|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
74040429|NCT01369212|147632797|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
74040430|NCT01369212|147632798|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
74009715|NCT00493220|147570521|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.79|||||TWO_SIDED|90.0|103.61|110.07|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||110.07|103.61|
74040431|NCT01369212|147632799|SUPERIORITY|||||||0.44|||||||Fisher Exact|||||||0.44
74040432|NCT01369212|147632800|SUPERIORITY|||||||0.06|||||||Fisher Exact|||||||0.06
74009716|NCT00493220|147570521|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|104.71|||||TWO_SIDED|90.0|101.59|107.92|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||107.92|101.59|
74009717|NCT00493220|147570522|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 95% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.76|||||TWO_SIDED|90.0|98.64|104.98|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||104.98|98.64|
74009718|NCT00493220|147570522|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.95|||||TWO_SIDED|90.0|103.67|110.33|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||110.33|103.67|
74009719|NCT00493220|147570522|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|105.1|||||TWO_SIDED|90.0|101.87|108.42|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||108.42|101.87|
74009720|NCT02426476|147570525|SUPERIORITY||||||<|0.01||||||Group by Time interaction|Mixed Models Analysis|||Linear mixed models for repeated measures (PROC MIXED in SAS) were used to assess the effects of intervention group, time, and the group by time interaction. A directional (one-sided) hypothesis was tested for the Group-by-Time interaction. The covariance matrix that minimized the Akaike Information Criterion was used. Each outcome was evaluated separately. Models were adjusted for baseline depression score and race.||||<0.01
74009721|NCT02426476|147570526|SUPERIORITY|||||||0.87||||||Group by Time interaction|Mixed Models Analysis|||||||0.87
74040433|NCT01369212|147632801|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
74040434|NCT01369212|147632802|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
74040435|NCT01369212|147632803|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
74040436|NCT01369212|147632804|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
74040437|NCT01369212|147632805|SUPERIORITY|||||||0.87|||||||Fisher Exact|||||||0.87
74040438|NCT01369212|147632806|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
74040439|NCT01369212|147632807|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
74040440|NCT01369212|147632809|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
74040441|NCT01369212|147632810|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
74040442|NCT00862121|147632811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.212||||0.231|TWO_SIDED|95.0|0.017|2.683|||Regression, Logistic|||The odds ratio (OR) for Baseline CDAI measures the effect of an increase of one unit on the outcome. The OR \[95% CI\] and p-value (likelihood-based) are for Pentasa versus placebo estimated in a logistic regression analysis including TREATMENT and CDAI at baseline as covariates. Power to demonstrate superiority of PENTASA Sachet 6 g/day over placebo in the primary efficacy analysis was 90% for a planned sample size of 255 participants per treatment arm (assuming 10% nonassessable participants).||2.683|0.017|0.231
74040443|NCT01033487|147632826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0507|STANDARD_ERROR_OF_MEAN|0.0339|||ONE_SIDED|90.0|0.0059||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90 percent (%) confidence interval (CI) was reported.|||0.0059|
73879098|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.28|-2.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.10|-5.28|<0.0001
74040444|NCT01033487|147632826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0788|STANDARD_ERROR_OF_MEAN|0.027|||ONE_SIDED|90.0|0.0431||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0431|
74040445|NCT01033487|147632826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0927|STANDARD_ERROR_OF_MEAN|0.0277|||ONE_SIDED|90.0|0.056||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0560|
74040446|NCT01033487|147632826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0613|STANDARD_ERROR_OF_MEAN|0.03|||ONE_SIDED|90.0|0.0215||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0215|
74040447|NCT01033487|147632826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0105|STANDARD_ERROR_OF_MEAN|0.0309|||ONE_SIDED|80.0|-0.0371||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||-0.0371|
74040448|NCT01033487|147632826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0175|STANDARD_ERROR_OF_MEAN|0.0246|||ONE_SIDED|80.0|-0.0037||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||-0.0037|
74040449|NCT01033487|147632826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0315|STANDARD_ERROR_OF_MEAN|0.0294|||ONE_SIDED|80.0|0.0062||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||0.0062|
74040450|NCT01033487|147632835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0989|STANDARD_ERROR_OF_MEAN|0.242|||ONE_SIDED|90.0|0.0676||||ANOVA|||Mixed effects analysis of variance (ANOVA) was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0676|
74040451|NCT01033487|147632835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1748|STANDARD_ERROR_OF_MEAN|0.0245|||ONE_SIDED|90.0|0.1431||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1431|
74040452|NCT01033487|147632835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1909|STANDARD_ERROR_OF_MEAN|0.0243|||ONE_SIDED|90.0|0.1594||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1594|
74040453|NCT01033487|147632835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1528|STANDARD_ERROR_OF_MEAN|0.0237|||ONE_SIDED|90.0|0.1222||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1222|
74040454|NCT01033487|147632835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0539|STANDARD_ERROR_OF_MEAN|0.0239|||ONE_SIDED|90.0|-0.0849||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0849|
74040455|NCT01033487|147632835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_DEVIATION|0.0238|||ONE_SIDED|90.0|-0.0088||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0088|
74040456|NCT01033487|147632835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0381|STANDARD_ERROR_OF_MEAN|0.0242|||ONE_SIDED|90.0|0.0068||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0068|
74040457|NCT01033487|147632836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0852|STANDARD_ERROR_OF_MEAN|0.0214|||ONE_SIDED|90.0|0.0576||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0576|
74040458|NCT01033487|147632836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1418|STANDARD_ERROR_OF_MEAN|0.0219|||ONE_SIDED|90.0|0.1136||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1136|
74040459|NCT01033487|147632836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1692|STANDARD_ERROR_OF_MEAN|0.0216|||ONE_SIDED|90.0|0.1413||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1413|
74040460|NCT01033487|147632836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1526|STANDARD_ERROR_OF_MEAN|0.0212|||ONE_SIDED|90.0|0.1252||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1252|
73887956|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|292.5|||<|0.0001|TWO_SIDED|95.0|240.0|345.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||345.1|240.0|<0.0001
74040461|NCT01033487|147632836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0674|STANDARD_ERROR_OF_MEAN|0.0211|||ONE_SIDED|90.0|-0.0946||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0946|
74040462|NCT01033487|147632836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0108|STANDARD_ERROR_OF_MEAN|0.0213|||ONE_SIDED|90.0|-0.0383||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0383|
74009722|NCT02426476|147570527|SUPERIORITY||||||<|0.01||||||Group by Time Interaction|Mixed Models Analysis|||Linear mixed models for repeated measures (PROC MIXED in SAS) were used to assess the effects of intervention group, time, and the group by time interaction. A directional (one-sided) hypothesis was tested for the Group-by-Time interaction. The covariance matrix that minimized the Akaike Information Criterion was used. Each outcome was evaluated separately. Models were adjusted for baseline depression score and race.||||<0.01
74009723|NCT03023930|147570528|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|proc logistic||||||<0.001
74009724|NCT03023930|147570529|SUPERIORITY|||||||0.011|||||||Regression, Logistic|proc logistic||||||0.011
74009725|NCT00445224|147570554|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||ANOVA|||||||.041
74009726|NCT00445224|147570555|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANOVA|||Repeated measures ANOVA for group and time||||.049
74009727|NCT00841204|147570559|OTHER|||||||0.0056|||||||Wilcoxon (Mann-Whitney)|||||||0.0056
74009728|NCT00841204|147570560|OTHER|||||||0.386|||||||Wilcoxon (Mann-Whitney)|||||||0.386
74009729|NCT00841204|147570561|OTHER||||||<|0.05|||||||Regression, Linear|||||||<0.05
74009730|NCT00841204|147570562|OTHER|||||||0.58|||||||Regression, Linear|||||||0.58
74040463|NCT01033487|147632836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0166|STANDARD_ERROR_OF_MEAN|0.213|||ONE_SIDED|90.0|-0.011||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0110|
74040464|NCT00676793|147632851|SUPERIORITY_OR_OTHER||||||=|0.078||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.||||=0.078
74009731|NCT00841204|147570563|OTHER|||||||0.12|||||||Regression, Linear|||||||0.12
74009732|NCT03227471|147570598|OTHER|||||||0.9943||||||P value within treatment|Mixed-effects model for repeated measure|||||||0.9943
74009733|NCT03227471|147570598|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
74009734|NCT03227471|147570598|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||< 0.0001
74009735|NCT03227471|147570598|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
74009736|NCT03227471|147570599|OTHER|||||||0.8869||||||P value within treatment.|Mixed-effects model for repeated measure|||||||0.8869
74040465|NCT00676793|147632852|SUPERIORITY_OR_OTHER||||||=|0.094||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.||||=0.094
74009737|NCT03227471|147570599|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
74009738|NCT03227471|147570600|OTHER|||||||0.6407||||||P value within treatment|Mixed-effects model for repeated measure|||||||0.6407
74009739|NCT03227471|147570600|OTHER||||||<|0.0001||||||P value within treatment.|mixed-effects model for repeated measure|||||||<0.0001
74009740|NCT03227471|147570615|OTHER|||||||0.5802||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.5802
74009741|NCT03227471|147570615|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
74009742|NCT03227471|147570615|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
74009743|NCT03227471|147570615|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
74009744|NCT03227471|147570616|OTHER|||||||0.8712||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.8712
74009745|NCT03227471|147570616|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
74009746|NCT03227471|147570617|OTHER|||||||0.8359||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.8359
74009747|NCT03227471|147570617|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
74009748|NCT03227471|147570618|OTHER|||||||0.9453||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.9453
74040466|NCT01316939|147632914|SUPERIORITY_OR_OTHER||Percent difference of participants|-4.0|||||TWO_SIDED|95.0|-12.9|4.8||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52||4.8|-12.9|
74009749|NCT03227471|147570618|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
74009750|NCT03227471|147570618|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
74009751|NCT03227471|147570618|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
74009752|NCT03227471|147570619|OTHER|||||||0.7849||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.7849
74009753|NCT03227471|147570619|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
74040467|NCT01316939|147632914|SUPERIORITY_OR_OTHER||Percent difference of participants|-6.6|||||TWO_SIDED|95.0|-14.8|1.6||||||Placebo Vs GSK1605786A 500 mg BID at Week 28 and 52||1.6|-14.8|
74040468|NCT01316939|147632915|SUPERIORITY_OR_OTHER||Percent difference of participants|-4.0|||||TWO_SIDED|95.0|-12.2|4.2||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52||4.2|-12.2|
74040469|NCT01316939|147632915|SUPERIORITY_OR_OTHER||Percent difference of participants|-5.3|||||TWO_SIDED|95.0|-13.1|2.6||||||||2.6|-13.1|
74040470|NCT01634113|147632939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.117||0.4963|TWO_SIDED|95.0|-0.312|0.152||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.152|-0.312|0.4963
74040471|NCT01634113|147632939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.123||0.6936|TWO_SIDED|95.0|-0.292|0.195||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.195|-0.292|0.6936
74009754|NCT03227471|147570620|OTHER|||||||0.7356||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.7356
74009755|NCT03227471|147570620|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
74009756|NCT03227471|147570621|OTHER|||||||0.394||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.3940
74009757|NCT03227471|147570621|OTHER|||||||0.0003||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.0003
74009758|NCT03227471|147570621|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
74009759|NCT03227471|147570621|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
74092536|NCT02504671|147737905|OTHER||Difference|64.9|||||TWO_SIDED|95.0|48.9|80.8|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||80.8|48.9|
74009760|NCT03227471|147570622|OTHER|||||||0.4757||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.4757
74009761|NCT03227471|147570622|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
74009762|NCT03227471|147570623|OTHER|||||||0.007||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.0070
74009763|NCT03227471|147570623|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
74009764|NCT02414399|147570627|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.58|TWO_SIDED|95.0|0.64|1.29||Alpha =0.045 (to account for .005 alpha spending at interim analysis)|Regression, Cox||azithromycin is the numerator and placebo is the denominator|Death or rehospitalization||1.29|.64|0.58
74009765|NCT02414399|147570627|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.49|TWO_SIDED|95.0|0.39|1.58|||Regression, Cox||Azithromycin-numerator and placebo-denominator|Death alone||1.58|0.39|0.49
74009766|NCT02414399|147570627|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.7|1.47|||Regression, Cox||numerator-azithromycin denominator-placebo|Rehospitalization alone||1.47|.70|.94
74092537|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092538|NCT02504671|147737905|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
74009767|NCT02414399|147570635|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.77|||||||Chi-squared|||M0||||0.77
74009768|NCT02414399|147570635|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.088|||||||Chi-squared|||Month 3||||0.088
74009769|NCT02414399|147570635|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.44|||||||Chi-squared|||M6||||0.44
74009770|NCT02142738|147570637|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.37|0.68||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||||0.68|0.37|<0.001
74009771|NCT02142738|147570638|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.002|TWO_SIDED|95.0|0.47|0.86||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||||0.86|0.47|0.002
74009772|NCT02142738|147570639|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|16.6||||0.0011|TWO_SIDED|95.0|6.0|27.0||One-sided p-value for testing|Miettinen & Nurminem method|Stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||H0: difference in %=0 vs. H1: difference in % \>0||27.0|6.0|0.0011
74009773|NCT01704287|147570652|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1); lactate dehydrogenase (LDH) levels (normal vs. elevated LDH levels \[≥110% Upper Limit of Normal (ULN)\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|||0.73|0.46|<0.0001
74009774|NCT01704287|147570652|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.37|0.6||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|||0.60|0.37|<0.0001
74009775|NCT01704287|147570652|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.83||||0.1247|TWO_SIDED|95.0|0.66|1.05||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|||1.05|0.66|0.1247
74009776|NCT01704287|147570653|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.1173|TWO_SIDED|95.0|0.67|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.10|0.67|0.1173
74009777|NCT01704287|147570653|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0106|TWO_SIDED|95.0|0.57|0.96||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.96|0.57|0.0106
74009778|NCT01704287|147570653|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.2905|TWO_SIDED|95.0|0.67|1.12||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.12|0.67|0.2905
74009779|NCT01704287|147570654|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.1146|TWO_SIDED|95.0|0.68|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.10|0.68|0.1146
74009780|NCT01704287|147570654|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.0023|TWO_SIDED|95.0|0.55|0.9||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.90|0.55|0.0023
74009781|NCT01704287|147570654|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.149|TWO_SIDED|95.0|0.66|1.07||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.07|0.66|0.1490
74009782|NCT01704287|147570655|SUPERIORITY_OR_OTHER_LEGACY|PD-L1-Positive Participants|Hazard Ratio (HR)|0.92||||0.3113|TWO_SIDED|95.0|0.66|1.28||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.28|0.66|0.3113
74009783|NCT01704287|147570655|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Positive Participants|Hazard Ratio (HR)|0.7||||0.0208|TWO_SIDED|95.0|0.5|0.99||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.99|0.50|0.0208
74009784|NCT01704287|147570655|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Positive Participants|Hazard Ratio (HR)|0.71||||0.0496|TWO_SIDED|95.0|0.5|1.0||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.00|0.50|0.0496
74009785|NCT01704287|147570655|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|1.07||||0.6043|TWO_SIDED|95.0|0.65|1.76||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.76|0.65|0.6043
74009786|NCT01704287|147570655|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|0.62||||0.0335|TWO_SIDED|95.0|0.37|1.04||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.04|0.37|0.0335
74009787|NCT01704287|147570655|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|0.71||||0.1504|TWO_SIDED|95.0|0.44|1.13||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.13|0.44|0.1504
74009788|NCT04024228|147570662|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.9|||||TWO_SIDED|95.0|1.58|2.28||||||A/H1N1: 60-64 years||2.28|1.58|
74009789|NCT04024228|147570662|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.7|||||TWO_SIDED|95.0|1.38|2.08||||||A/H3N2: 60-64 years||2.08|1.38|
74009790|NCT04024228|147570662|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.51|||||TWO_SIDED|95.0|1.3|1.74||||||B1: 60-64 years||1.74|1.30|
74009791|NCT04024228|147570662|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.77|||||TWO_SIDED|95.0|1.53|2.04||||||B2: 60-64 years||2.04|1.53|
74040472|NCT01634113|147632941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083|STANDARD_ERROR_OF_MEAN|0.157||0.5995|TWO_SIDED|95.0|-0.229|0.394||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.394|-0.229|0.5995
74009792|NCT04024228|147570662|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.76|||||TWO_SIDED|95.0|1.44|2.15||||||A/H1N1: \>=65 years||2.15|1.44|
73879099|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.81||0.0315|TWO_SIDED|95.0|-3.33|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.16|-3.33|0.0315
73879100|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0063|TWO_SIDED|95.0|-3.75|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.62|-3.75|0.0063
73879101|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0007|TWO_SIDED|95.0|-4.25|-1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.14|-4.25|0.0007
73879102|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.81||0.109|TWO_SIDED|95.0|-2.89|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.29|-2.89|0.1090
73879103|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.0018|TWO_SIDED|95.0|-4.14|-0.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.95|-4.14|0.0018
73879104|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.81||0.0004|TWO_SIDED|95.0|-4.54|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.34|-4.54|0.0004
73879105|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-5.4|-2.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.15|-5.40|<0.0001
73879106|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.82||0.0231|TWO_SIDED|95.0|-3.5|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.26|-3.50|0.0231
73879107|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.81||0.0056|TWO_SIDED|95.0|-3.86|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.67|-3.86|0.0056
74092539|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
73879108|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.81||0.0007|TWO_SIDED|95.0|-4.35|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.17|-4.35|0.0007
73879109|NCT03192176|147297609|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.81||0.3568|TWO_SIDED|95.0|-2.35|0.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.85|-2.35|0.3568
73879110|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.82||0.0129|TWO_SIDED|95.0|-3.65|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.43|-3.65|0.0129
73879111|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.82||0.0018|TWO_SIDED|95.0|-4.19|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.97|-4.19|0.0018
73879112|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.83||0.0003|TWO_SIDED|95.0|-4.7|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.42|-4.70|0.0003
73879113|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.83||0.1004|TWO_SIDED|95.0|-3.0|0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.27|-3.00|0.1004
74092540|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092541|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092542|NCT02504671|147737905|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
74009793|NCT04024228|147570662|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|2.15|||||TWO_SIDED|95.0|1.74|2.65||||||A/H3N2: \>=65 years||2.65|1.74|
74009794|NCT04024228|147570662|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.55|||||TWO_SIDED|95.0|1.34|1.79||||||B1: \>=65 years||1.79|1.34|
74009795|NCT04024228|147570662|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.76|||||TWO_SIDED|95.0|1.52|2.03||||||B2: \>=65 years||2.03|1.52|
74009796|NCT04490395|147570679|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.044|TWO_SIDED|95.0|-0.26|3.62|||t-test, 2 sided|||||3.62|-0.26|0.044
74009797|NCT04490395|147570680|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.056|TWO_SIDED|95.0|-0.15|1.33|||t-test, 2 sided|||||1.33|-0.15|0.056
74009798|NCT04490395|147570681|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.377|TWO_SIDED|95.0|-1.75|1.28|||t-test, 2 sided|||||1.28|-1.75|0.377
74009799|NCT04490395|147570682|SUPERIORITY|Within subjects change over time|F test (1,15) df|1.381||||0.258|TWO_SIDED||||||ANOVA|Change over time||Only 9 cases had any data available per group, and some had missing values and were not included in each analysis.|Within subjects change over time.|||0.258
74009800|NCT04490395|147570682|SUPERIORITY|Between group analysis|F test (1,15) df|0.246||||0.627|TWO_SIDED||||||ANOVA||||Between group analysis|||0.627
74009801|NCT04490395|147570682|SUPERIORITY||F test (1,15) df|0.005||||0.947|TWO_SIDED||||||ANOVA|||Time x Condition interaction|Time x Condition interaction|||0.947
74009802|NCT04490395|147570683|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.038|TWO_SIDED|95.0|-1.85|0.98|||t-test, 2 sided|||||0.98|-1.85|0.038
74009803|NCT04490395|147570684|SUPERIORITY||Mean Difference (Final Values)|-2.56||||0.07|TWO_SIDED|95.0|-6.05|0.94|||t-test, 2 sided|||||0.94|-6.05|0.07
74009804|NCT04490395|147570685|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.43|TWO_SIDED|95.0|-1.19|1.42|||t-test, 2 sided|||||1.42|-1.19|0.43
74009805|NCT04490395|147570686|SUPERIORITY||Mean Difference (Final Values)|-0.029||||0.72|TWO_SIDED|95.0|-0.194|1.42|||t-test, 2 sided|||||1.42|-.194|0.72
74009806|NCT04490395|147570687|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.341|TWO_SIDED|95.0|-0.35|0.23|||t-test, 2 sided|||||0.23|-0.35|0.341
74009807|NCT04490395|147570688|SUPERIORITY||Mean Difference (Final Values)|-0.059||||0.25|TWO_SIDED|95.0|-2.35|1.17|||t-test, 2 sided|||||1.17|-2.35|0.25
74009808|NCT00938717|147570689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.65|||<|0.0001|TWO_SIDED|95.0|2.44|8.84||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||8.84|2.44|<0.0001
74040473|NCT01634113|147632941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015|STANDARD_ERROR_OF_MEAN|0.16||0.9251|TWO_SIDED|95.0|-0.303|0.333||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.333|-0.303|0.9251
74009809|NCT00938717|147570690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.5|7.03||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||7.03|2.50|<0.0001
74009810|NCT00938717|147570691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.0001|TWO_SIDED|95.0|1.91|3.6||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||3.60|1.91|<0.0001
74009811|NCT00938717|147570692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|2.22|4.49||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."||4.49|2.22|<0.0001
74009812|NCT01462435|147570711|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|446.946|STANDARD_ERROR_OF_MEAN|122.2935|<|0.001|TWO_SIDED|95.0|206.567|687.324|||ANCOVA|||||687.324|206.567|<0.001
74009813|NCT01462435|147570711|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|316.145|STANDARD_ERROR_OF_MEAN|121.5971||0.01|TWO_SIDED|95.0|77.136|555.155|||ANCOVA|||||555.155|77.136|0.010
74009814|NCT01462435|147570711|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|313.119|STANDARD_ERROR_OF_MEAN|122.5676||0.011|TWO_SIDED|95.0|72.202|554.037|||ANCOVA|||||554.037|72.202|0.011
74009815|NCT01462435|147570712|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||t-test, 2 sided|||||||0.043
74009816|NCT01462435|147570712|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||t-test, 2 sided|||||||0.109
74009817|NCT01462435|147570712|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||t-test, 2 sided|||||||0.183
74009818|NCT01462435|147570713|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
74009819|NCT01462435|147570713|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||t-test, 2 sided|||||||0.029
74009820|NCT01462435|147570713|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.050
74009821|NCT01462435|147570714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74009822|NCT01462435|147570714|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
74009823|NCT01462435|147570714|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
74009824|NCT01462435|147570715|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
74009825|NCT01462435|147570715|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||t-test, 2 sided|||||||0.091
74009826|NCT01462435|147570715|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||t-test, 2 sided|||||||0.053
74009827|NCT01462435|147570716|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||||||0.002
74009828|NCT01462435|147570716|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||t-test, 2 sided|||||||0.026
74009829|NCT01462435|147570716|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
74009830|NCT01462435|147570717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74009831|NCT01462435|147570717|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
74009832|NCT01462435|147570717|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
74009833|NCT01462435|147570718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74009834|NCT01462435|147570718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74009835|NCT01462435|147570718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74009836|NCT00857532|147570733|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||Spearman's Rank Order Correlation|||"P-value for Attention correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 attention score."||||0.021
74009837|NCT00857532|147570733|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||Spearman's Rank Order Correlation|||"P-value for Initiation/Perseveration correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 initiation/perseveration score."||||0.077
74009838|NCT00857532|147570733|SUPERIORITY_OR_OTHER|||||||0.364||95.0|||||Spearman's Rank Order Correlation|||"P-value for Construction correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 construction score."||||0.364
74009839|NCT00857532|147570733|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Spearman's Rank Order Correlation|||"P-value for Conceptualization correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 conceptualization score."||||0.266
74009840|NCT00857532|147570733|SUPERIORITY_OR_OTHER|||||||0.152||95.0|||||Spearman's Rank Order Correlation|||"P-value for Memory correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 memory score."||||0.152
74009841|NCT00857532|147570733|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Spearman's Rank Order Correlation|||"P-value for DRS-2 Total correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 total score."||||0.041
74009842|NCT00857532|147570734|SUPERIORITY_OR_OTHER|||||||0.0411||95.0|||||Spearman's Rank Order Correlation|||"P-value for Amyloid beta correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and amyloid beta."||||0.0411
74009843|NCT00857532|147570734|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Spearman's Rank Order Correlation|||"P-value for Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and tau."||||0.5800
74009844|NCT00857532|147570734|SUPERIORITY_OR_OTHER|||||||0.8164||95.0|||||Spearman's Rank Order Correlation|||"P-value for Phospho-Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and phospho-tau."||||0.8164
74009845|NCT00257725|147570735|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.09|STANDARD_DEVIATION|0.73||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
74009846|NCT00257725|147570736|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.64|STANDARD_DEVIATION|1.29||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
74009847|NCT00257725|147570737|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.55|STANDARD_DEVIATION|7.7||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
74009848|NCT01858532|147570738|OTHER||||||=|0.029|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||=0.029
74009849|NCT01858532|147570738|OTHER||Hazard Ratio (HR)|0.654|||=|0.005|TWO_SIDED|95.0|0.488|0.878|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.878|0.488|=0.005
74009850|NCT01858532|147570739|OTHER||||||=|0.289|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||=0.289
74009851|NCT01858532|147570739|OTHER||Hazard Ratio (HR)|0.779||||0.112|TWO_SIDED|95.0|0.573|1.06|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||1.060|0.573|0.112
74009852|NCT01858532|147570740|OTHER|||||||0.089|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||0.089
74009853|NCT01858532|147570740|OTHER||Hazard Ratio (HR)|0.801||||0.049|TWO_SIDED|95.0|0.642|0.999|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.999|0.642|0.049
74009854|NCT01858532|147570741|OTHER||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.58|0.89|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.89|0.58|0.002
74009855|NCT01858532|147570742|OTHER|||||||0.446|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||0.446
74009856|NCT01858532|147570742|OTHER||Hazard Ratio (HR)|0.884||||0.447|TWO_SIDED|95.0|0.643|1.215|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||1.215|0.643|0.447
74009857|NCT00514514|147570743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.56|||<|0.0001|TWO_SIDED|95.0|2.82|8.31|||ANCOVA|||||8.31|2.82|< 0.0001
74009858|NCT00003895|147570786|SUPERIORITY_OR_OTHER||||||<|0.001||||||Post versus Pre-treatment % g209-2M-specific t-cells|t-test, 2 sided|||||||<.001
74009859|NCT00003895|147570786|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Post versus Pre-Treatment %g209-2M-specific T-cells|t-test, 2 sided|||||||<.0001
74009860|NCT00003895|147570786|SUPERIORITY_OR_OTHER|||||||0.59||||||Arm A Versus Arm B|t-test, 2 sided|||||||0.59
74040474|NCT01634113|147632942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.25|STANDARD_ERROR_OF_MEAN|10.324||0.8279|TWO_SIDED|95.0|-18.243|22.743||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||22.743|-18.243|0.8279
74040475|NCT01634113|147632942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.497|STANDARD_ERROR_OF_MEAN|10.826||0.8181|TWO_SIDED|95.0|-23.987|18.994||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||18.994|-23.987|0.8181
74040476|NCT01634113|147632944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.061|STANDARD_ERROR_OF_MEAN|0.112||0.5869|TWO_SIDED|95.0|-0.161|0.283||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.283|-0.161|0.5869
74040477|NCT01634113|147632944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.116||0.523|TWO_SIDED|95.0|-0.305|0.156||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.156|-0.305|0.5230
74040478|NCT01357980|147633023|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.54||||0.11|TWO_SIDED|95.0|-3.47|0.39||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.||0.39|-3.47|0.11
74040479|NCT01357980|147633023|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.61||||0.07|TWO_SIDED|95.0|-1.27|0.05||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.||0.05|-1.27|0.07
74040480|NCT01357980|147633024|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|219.5|||<|0.01|TWO_SIDED|95.0|69.6|369.5|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||369.5|69.6|<0.01
74040481|NCT01357980|147633024|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|224.1|||<|0.01|TWO_SIDED|95.0|140.9|307.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||307.4|140.9|<0.01
74040482|NCT01357980|147633024|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|117.0||||0.09||95.0|-20.0|254.0|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||254.0|-20.0|0.09
74040483|NCT01357980|147633024|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|223.7|||<|0.01|TWO_SIDED|95.0|94.3|353.1|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||353.1|94.3|<0.01
74040484|NCT01357980|147633024|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|138.5||||0.01|TWO_SIDED|95.0|34.7|242.2|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||242.2|34.7|0.01
74040485|NCT01357980|147633024|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|186.3|||<|0.01|TWO_SIDED|95.0|53.2|319.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||319.4|53.2|<0.01
74040486|NCT01357980|147633025|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-23.8||||0.25|TWO_SIDED|95.0|-66.6|18.9|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||18.9|-66.6|0.25
74040487|NCT01357980|147633025|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-67.1|||<|0.01|TWO_SIDED|95.0|-112.9|-21.2|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-21.2|-112.9|<0.01
74040488|NCT01357980|147633025|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-35.1||||0.03|TWO_SIDED|95.0|-65.6|-4.6|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-4.6|-65.6|0.03
74040489|NCT01357980|147633025|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-51.0||||0.01|TWO_SIDED|95.0|-89.5|-12.4|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-12.4|-89.5|0.01
74040490|NCT01357980|147633025|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-32.3|||<|0.01|TWO_SIDED|95.0|-53.7|-11.0|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-11.0|-53.7|<0.01
74040491|NCT01357980|147633025|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-45.3|||<|0.01|TWO_SIDED|95.0|-76.6|-14.1|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-14.1|-76.6|<0.01
74040492|NCT01357980|147633026|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.7||||0.05||95.0|||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.05
74040493|NCT01357980|147633026|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.3|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
74040494|NCT01357980|147633027|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.3||||0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.01
74040495|NCT01357980|147633027|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.8|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
73879114|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.82||0.0173|TWO_SIDED|95.0|-3.57|-0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.35|-3.57|0.0173
73879115|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.81||0.0038|TWO_SIDED|95.0|-3.97|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.77|-3.97|0.0038
73879116|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.78||0.1767|TWO_SIDED|95.0|-2.57|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.48|-2.57|0.1767
73879117|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.77||0.0308|TWO_SIDED|95.0|-3.2|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.16|-3.20|0.0308
73879118|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.78||0.0013|TWO_SIDED|95.0|-4.07|-1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.00|-4.07|0.0013
73879119|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.47|-1.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.36|-4.47|0.0003
73879120|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.79||0.2109|TWO_SIDED|95.0|-2.55|0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.56|-2.55|0.2109
73879121|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0152|TWO_SIDED|95.0|-3.44|-0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.37|-3.44|0.0152
73879122|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.77||0.0075|TWO_SIDED|95.0|-3.61|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.56|-3.61|0.0075
73879123|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.0869|TWO_SIDED|95.0|-2.96|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.20|-2.96|0.0869
73879124|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.052|TWO_SIDED|95.0|-3.14|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.01|-3.14|0.0520
73879125|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.81||0.0009|TWO_SIDED|95.0|-4.3|-1.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.12|-4.30|0.0009
73879126|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.82||0.0002|TWO_SIDED|95.0|-4.68|-1.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.46|-4.68|0.0002
74040496|NCT01357980|147633028|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.9||||0.05|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.05
74040497|NCT01357980|147633028|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.1|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
73879127|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.82||0.0456|TWO_SIDED|95.0|-3.25|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-0.03|-3.25|0.0456
73879128|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.81||0.0073|TWO_SIDED|95.0|-3.76|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.59|-3.76|0.0073
73879129|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.8||0.0026|TWO_SIDED|95.0|-4.01|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.86|-4.01|0.0026
73879130|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.78||0.0878|TWO_SIDED|95.0|-2.87|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.20|-2.87|0.0878
73879131|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0182|TWO_SIDED|95.0|-3.39|-0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.32|-3.39|0.0182
74009861|NCT00806195|147570789|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the safety objective was that the upper limit of the two-sided 95% CI for this difference in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days after any vaccination (PMenACWY+Routine Vaccines-PRoutine Vaccines) was ≥ 6%.|Mean Difference (Final Values)|3.0|||||TWO_SIDED|95.0|-0.8|6.4|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered noninferior to routine vaccines alone with respect to severe systemic reactions if the upper limit of the 2-sided 95% CI of the difference (MenACWY-CRM197 vaccine plus routine vaccines group minus routine vaccines only group) in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days (days 1-7) after any vaccination was \<6%.||6.4|-0.8|
74009862|NCT00806195|147570790|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was ≥5%.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.9|1.5|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \<5%.||1.5|-0.9|
73879132|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.79||0.0002|TWO_SIDED|95.0|-4.55|-1.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.44|-4.55|0.0002
73879133|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.8||0.0002|TWO_SIDED|95.0|-4.53|-1.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.40|-4.53|0.0002
73879134|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.8||0.0387|TWO_SIDED|95.0|-3.22|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.09|-3.22|0.0387
73879135|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.79||0.0031|TWO_SIDED|95.0|-3.89|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.80|-3.89|0.0031
73879136|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.78||0.0029|TWO_SIDED|95.0|-3.88|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.81|-3.88|0.0029
74040498|NCT01357980|147633029|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.13|||<|0.01|TWO_SIDED|95.0|-1.91|-0.35|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||-0.35|-1.91|<0.01
73879137|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.76||0.0653|TWO_SIDED|95.0|-2.9|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.09|-2.90|0.0653
74040499|NCT01357980|147633029|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.18||||0.7|TWO_SIDED|95.0|-1.26|0.9|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.90|-1.26|0.7
74040500|NCT01357980|147633029|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.52||||0.3|TWO_SIDED|95.0|-1.56|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.52|-1.56|0.3
74040501|NCT01357980|147633029|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.48||||0.3|TWO_SIDED|95.0|-1.47|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.52|-1.47|0.3
73879138|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.76||0.0102|TWO_SIDED|95.0|-3.46|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.47|-3.46|0.0102
73879139|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.77||0.0002|TWO_SIDED|95.0|-4.38|-1.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.36|-4.38|0.0002
74040502|NCT01357980|147633029|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.38|||<|0.01|TWO_SIDED|95.0|-2.02|-0.73|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||-0.73|-2.02|<0.01
74040503|NCT01357980|147633029|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.4||||0.4|TWO_SIDED|95.0|-1.35|0.55|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.55|-1.35|0.4
74040504|NCT04507776|147633033|OTHER|||||||0.75|||||||t-test, 2 sided|||Year 1 Adherence: Baseline||||0.75
74040505|NCT04507776|147633033|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 1 Adherence: Year 1 (Month 12)||||<0.05
74040506|NCT04507776|147633033|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 7 Adherence: Baseline||||<0.05
74040507|NCT04507776|147633033|OTHER|||||||0.43|||||||t-test, 2 sided|||Year 7 Adherence: Year 7||||0.43
74040508|NCT04507776|147633034|OTHER|||||||0.0001|||||||t-test, 2 sided|||Year 1 Adherence: Change at Year 1 (Month 12)||||0.0001
74040509|NCT04507776|147633034|OTHER|||||||0.247|||||||t-test, 2 sided|||Year 7 Adherence: Change at Year 7||||0.247
74040510|NCT04507776|147633035|OTHER|||||||0.21|||||||t-test, 2 sided|||Year 1 Adherence: Baseline||||0.21
74040511|NCT04507776|147633035|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 1 Adherence: Year 1 (Month 12)||||<0.05
74040512|NCT04507776|147633035|OTHER|||||||0.62|||||||t-test, 2 sided|||Year 7 Adherence: Baseline||||0.62
74040513|NCT04507776|147633035|OTHER|||||||0.18|||||||t-test, 2 sided|||Year 7 Adherence: Year 7||||0.18
74040514|NCT04507776|147633036|OTHER|||||||0.0001|||||||t-test, 2 sided|||Year 1 Adherence: Change at Year 1 (Month 12)||||0.0001
74040515|NCT04507776|147633036|OTHER|||||||0.003|||||||t-test, 2 sided|||Year 7 Adherence: Change at Year 7||||0.003
74040516|NCT00132314|147633042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.39|TWO_SIDED|95.0|0.63|1.2|||Log Rank|||Time-to-event analysis; The primary outcome hypothesis is tested using a two-sided log-rank test to compare the hazard rate for the IM treatment group to that for the oral treatment group.||1.20|0.63|0.39
74040517|NCT00132314|147633043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.63|1.2||95% Confidence Interval: 0.63 to 1.20|Regression, Cox|||||1.20|0.63|
74040518|NCT00698035|147633085|SUPERIORITY_OR_OTHER||||||>|0.05||||||Significant at p\<0.05|t-test, 2 sided|||Comparison of baseline estradiol between LC/MS and RIA||||>0.05
74040519|NCT00698035|147633085|SUPERIORITY_OR_OTHER||||||>|0.05||||||singificant at p\<0.05|t-test, 2 sided|||Comparison of week 4 estradiol between LC/MS and RIA||||>0.05
74040520|NCT00698035|147633088|SUPERIORITY_OR_OTHER|||||||0.021||||||Significant at p\<0.05|t-test, 2 sided|||Change in SI from BL to W12||||0.021
74040521|NCT00698035|147633088|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Change in SD from BL to W12||||<0.001
74040522|NCT00698035|147633088|SUPERIORITY_OR_OTHER|||||||0.0228||||||Significant at p\<0.05|t-test, 2 sided|||Change in SI from BL to W12||||0.0228
74040523|NCT00698035|147633088|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Change in SD from BL to W12||||<0.001
74040524|NCT00698035|147633089|SUPERIORITY_OR_OTHER|||||||0.004||||||Significant at p\<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12||||0.004
74040525|NCT00698035|147633089|SUPERIORITY_OR_OTHER|||||||0.139||||||Significant at p\<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12||||0.139
74040526|NCT00698035|147633090|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Differences in rugae, pallor, petechiae, mucosal thinning and dryness between baseline and week 12||||<0.001
74040527|NCT00698035|147633090|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Differences in rugae, pallor, mucosal thinning, and dryness from baseline to 12 weeks||||<0.001
74040528|NCT00698035|147633090|SUPERIORITY_OR_OTHER|||||||0.0061||||||Significant at p\<0.05|t-test, 2 sided|||Difference in petechiae between baseline and week 12||||0.0061
74040529|NCT02151682|147633132|NON_INFERIORITY|A logistic regression model was fitted to the response using baseline pain, age group, treatment, and underlying pain condition as explanatory variables, followed by a Farrington-Manning test for non-inferiority, based on Full Analysis Set.|Risk Difference (RD)|-0.06||||0.079|TWO_SIDED|80.0|-0.19|0.06||The p-value is based on Farrington-Manning variance estimator using a pre-specified non-inferiority margin of -0.2. A 1-sided alpha of 0.1 was used. A p-value \<0.1 represents non-inferiority.|Farrington-Manning test|Non-inferiority of tapentadol prolonged-release versus morphine prolonged-release has been demonstrated.|A confidence interval for the risk difference (RD) completely above the pre-specified non-inferiority margin of -0.2 represents non-inferiority of tapentadol prolonged-release versus morphine prolonged-release.|||0.06|-0.19|0.0790
74040530|NCT00168064|147633151|NON_INFERIORITY_OR_EQUIVALENCE|The PG formulation was determined to be non-inferior to the AP formulation if the lower limit of the 95% confidence interval around the ratio of the response rates (PG/AP) was \> = 0.75.|ratio of proportions|1.226|||||TWO_SIDED|95.0|0.974|1.552|||ANCOVA||ratio is response rate of PG formulation divided by response rate of AP formulation|||1.552|0.974|
74040531|NCT00318565|147633154|SUPERIORITY_OR_OTHER||Binomial distribution|93.3||||0.05|ONE_SIDED|95.0|90.1||||Exact binomial distribution|||An acute success rate of 88% is anticipated and the one-sided 95% lower confidence bound will be compared to 80%. The statistical hypothesis for the primary efficacy endpoint is evaluated as a one-tailed hypothesis at a = 0.05.|||90.1|.05
74040532|NCT00318565|147633155|SUPERIORITY_OR_OTHER||Binomial Distribution|1.5||||0.05|ONE_SIDED|95.0||7.0|||Exact Binomial Distribution|||The anticipated rate of the CSAE is 2.7% and the one-sided 95% upper confidence bound will be compared to 7%||7||.05
74040533|NCT00830960|147633156|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference in PRU|-183.0|||<|0.0001|TWO_SIDED|95.0|-229.0|-137.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.||||-137|-229|<0.0001
73879140|NCT03192176|147297609|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|-4.72|-1.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.67|-4.72|<0.0001
73879141|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.78||0.0231|TWO_SIDED|95.0|-3.3|-0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.25|-3.30|0.0231
73879142|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.78||0.0021|TWO_SIDED|95.0|-3.88|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.87|-3.88|0.0021
73879143|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.76||0.0021|TWO_SIDED|95.0|-3.88|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.87|-3.88|0.0021
73879144|NCT03192176|147297609|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.76||0.0013|TWO_SIDED|95.0|-3.96|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.97|-3.96|0.0013
73879145|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.84||0.146|TWO_SIDED|95.0|-2.89|0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.43|-2.89|0.1460
73879146|NCT03192176|147297609|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.84||0.6066|TWO_SIDED|95.0|-2.1|1.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||1.23|-2.10|0.6066
73879147|NCT03192176|147297609|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.87||0.8422|TWO_SIDED|95.0|-1.88|1.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.54|-1.88|0.8422
73879148|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.87||0.2346|TWO_SIDED|95.0|-2.74|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.67|-2.74|0.2346
73879149|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.87||0.1128|TWO_SIDED|95.0|-3.11|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.33|-3.11|0.1128
73879150|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.87||0.1811|TWO_SIDED|95.0|-2.89|0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.55|-2.89|0.1811
73879151|NCT03192176|147297609|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.3521|TWO_SIDED|95.0|-2.45|0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.87|-2.45|0.3521
74009863|NCT00806195|147570790|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was \<5%.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.8|1.3|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \<5%.||1.3|-0.8|
74009864|NCT00139776|147570810|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||"Null hypothesis for primary outcome is that there is no difference in the number of flares observed between the 2 treatment arms of celecoxib 200mg continuous use and celecoxib 200mg intermittent use.~Sample size calculation: Sufficient number of participants were randomized to provide at least 80% power to detect an estimated effect size of 0.2 using a 2-sided t-test at a 0.05 significant level."||||<0.0001
74009865|NCT00139776|147570811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|Log Rank|||Kaplan-Meier analysis||||<0.0001
73879152|NCT03192176|147297609|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.357|TWO_SIDED|95.0|-2.44|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.88|-2.44|0.3570
73879153|NCT03192176|147297609|SUPERIORITY||LSMean differencce|-0.1|STANDARD_ERROR_OF_MEAN|0.84||0.9227|TWO_SIDED|95.0|-1.73|1.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.57|-1.73|0.9227
74009866|NCT00139776|147570812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
74009867|NCT00139776|147570813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
74009868|NCT00139776|147570814|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4||||<0.001
74009869|NCT00139776|147570814|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8||||<0.001
74009870|NCT00139776|147570814|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12||||<0.001
74009871|NCT00139776|147570814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16||||0.003
74009872|NCT00139776|147570814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20||||0.022
74009873|NCT00139776|147570814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24||||0.047
74009874|NCT00139776|147570815|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4||||<0.001
74009875|NCT00139776|147570815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8||||0.001
74009876|NCT00139776|147570815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12||||0.096
74009877|NCT00139776|147570815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.338||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16||||0.338
74009878|NCT00139776|147570815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.832||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20||||0.832
74009879|NCT00139776|147570815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.972||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24||||0.972
74009880|NCT00139776|147570816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046||95.0||||Overall p-value Threshold for statistical significance p\<0.05|Cochran-Mantel-Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.0046
74009881|NCT00139776|147570817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0102||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||0.0102
74009882|NCT00139776|147570818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||0.0012
74009883|NCT00139776|147570819|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
74009884|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Total WOMAC score||||<0.001
74092543|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74009885|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.71||||95.0|0.21|2.99|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Continuous use||2.99|0.21|
74009886|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.99|STANDARD_ERROR_OF_MEAN|0.71||||95.0|3.6|6.38|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Intermittent use||6.38|3.60|
74009887|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale||||<0.001
74009888|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.15||||95.0|0.06|0.67|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Continuous use||0.67|0.06|
74009889|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|0.15||||95.0|0.88|1.49|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Intermittent use||1.49|0.88|
74009890|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale||||0.004
74009891|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.02|0.25|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Continuous use||0.25|-0.02|
74009892|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.07||||95.0|0.26|0.53|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Intermittent use||0.53|0.26|
74009893|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale||||0.002
74009894|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|0.51||||95.0|0.13|2.14|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Continuous use||2.14|0.13|
74009895|NCT00139776|147570820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.43|STANDARD_ERROR_OF_MEAN|0.51||||95.0|2.42|4.43|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Intermittent use||4.43|2.42|
74009896|NCT00139776|147570821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2712||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep disturbance||||0.2712
74009897|NCT00139776|147570821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8737||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Snoring||||0.8737
73879154|NCT03192176|147297609|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.87||0.8894|TWO_SIDED|95.0|-1.84|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.60|-1.84|0.8894
74009898|NCT00139776|147570821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7703||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Awaken short of breath||||0.7703
74009899|NCT00139776|147570821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3769||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Quantity of sleep||||0.3769
74009900|NCT00139776|147570821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4075||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep adequacy||||0.4075
74009901|NCT00139776|147570821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5854||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Somnolence||||0.5854
74092544|NCT02504671|147737905|OTHER||Difference|27.0|||||TWO_SIDED|95.0|11.4|42.7|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.7|11.4|
74009902|NCT00139776|147570821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8358||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index I||||0.8358
74009903|NCT00139776|147570821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5878||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index II||||0.5878
74009904|NCT00139776|147570822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC total score||||<0.001
74040534|NCT00830960|147633156|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-139.0|||<|0.0001|TWO_SIDED|95.0|-177.0|-102.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.||||-102|-177|<0.0001
74040535|NCT00830960|147633157|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-57.0||||0.0058|TWO_SIDED|95.0|-97.0|-17.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-17|-97|0.0058
74040536|NCT00830960|147633157|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-35.0||||0.0365|TWO_SIDED|95.0|-68.0|-2.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel"|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-2|-68|0.0365
74040537|NCT00830960|147633157|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-68.0||||0.0004|TWO_SIDED|95.0|-104.0|-32.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-32|-104|0.0004
74040538|NCT00830960|147633157|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-160.0|||<|0.0001|TWO_SIDED|95.0|-211.0|-110.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-110|-211|<0.0001
74040539|NCT00830960|147633157|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-115.0|||<|0.0001|TWO_SIDED|95.0|-156.0|-73.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-156|<0.0001
74092545|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092546|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74009905|NCT00139776|147570822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale||||<0.001
74009906|NCT00139776|147570822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale||||<0.001
74009907|NCT00139776|147570822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale||||<0.001
74009908|NCT00139776|147570823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1437||95.0||||Threshold for statistical significance p\<0.05|Cochran-Mantel-Haenszel|by general association||Analysis across all 3 sleep scores for Period III||||0.1437
74009909|NCT00139776|147570824|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical function||||<0.0001
73879155|NCT03192176|147297609|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.5074|TWO_SIDED|95.0|-2.29|1.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.13|-2.29|0.5074
73879156|NCT03192176|147297609|SUPERIORITY||LSMean differencce|-1.2|STANDARD_ERROR_OF_MEAN|0.87||0.1753|TWO_SIDED|95.0|-2.91|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.53|-2.91|0.1753
73879157|NCT03192176|147297609|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.88||0.1212|TWO_SIDED|95.0|-3.09|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.36|-3.09|0.1212
73879158|NCT03192176|147297609|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.3702|TWO_SIDED|95.0|-2.41|0.9||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.90|-2.41|0.3702
73879159|NCT03192176|147297609|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.81||0.6459|TWO_SIDED|95.0|-1.22|1.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.96|-1.22|0.6459
73879160|NCT03192176|147297609|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.8248|TWO_SIDED|95.0|-1.4|1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.75|-1.40|0.8248
73879161|NCT03192176|147297609|SUPERIORITY||LSMean difference|0.7|STANDARD_ERROR_OF_MEAN|0.84||0.4226|TWO_SIDED|95.0|-0.98|2.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.33|-0.98|0.4226
73879162|NCT03192176|147297609|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.83||0.6469|TWO_SIDED|95.0|-1.25|2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.01|-1.25|0.6469
73879163|NCT03192176|147297609|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.84||0.7642|TWO_SIDED|95.0|-1.41|1.91||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.91|-1.41|0.7642
73879164|NCT03192176|147297609|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.84||0.4068|TWO_SIDED|95.0|-2.36|0.966||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.966|-2.36|0.4068
73879165|NCT03192176|147297609|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.7974|TWO_SIDED|95.0|-1.37|1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.78|-1.37|0.7974
74009910|NCT00139776|147570824|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role physical||||<0.0001
74009911|NCT00139776|147570824|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Bodily pain||||<0.0001
74092547|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
73879166|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.78||0.0297|TWO_SIDED|95.0|-3.23|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.17|-3.23|0.0297
73879167|NCT03192176|147297610|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|-4.66|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.58|-4.66|<0.0001
74009912|NCT00139776|147570824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3097||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||General health||||0.3097
74009913|NCT00139776|147570824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0139||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Vitality||||0.0139
74009914|NCT00139776|147570824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1303||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Social functioning||||0.1303
74092548|NCT02504671|147737905|OTHER||Difference|56.8|||||TWO_SIDED|95.0|40.1|73.4|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.4|40.1|
74009915|NCT00139776|147570824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1404||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role emotional||||0.1404
74092549|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
73879168|NCT03192176|147297610|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.78|<|1e-05|TWO_SIDED|95.0|-5.1|-2.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.02|-5.10|<0.00001
73879169|NCT03192176|147297610|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|-5.78|-2.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.66|-5.78|<0.0001
73879170|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1318|TWO_SIDED|95.0|-2.76|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.36|-2.76|0.1318
73879171|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.001|TWO_SIDED|95.0|-4.13|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.05|-4.13|0.0010
73879172|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.0011|TWO_SIDED|95.0|-4.1|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.04|-4.10|0.0011
73879173|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.79||0.0405|TWO_SIDED|95.0|-3.2|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.07|-3.20|0.0405
73879174|NCT03192176|147297610|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.7|-1.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.55|-4.70|0.0001
73879175|NCT03192176|147297610|SUPERIORITY||LSMean differencce|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.66|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.52|-4.66|0.0001
73879176|NCT03192176|147297610|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.26|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.07|-5.26|<0.0001
74009916|NCT00139776|147570824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4015||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental health||||0.4015
73879177|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.81||0.0325|TWO_SIDED|95.0|-3.34|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.15|-3.34|0.0325
73879178|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.8||0.0035|TWO_SIDED|95.0|-3.92|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.78|-3.92|0.0035
74092550|NCT02504671|147737905|OTHER||Difference|32.4|||||TWO_SIDED|95.0|16.2|48.7|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.7|16.2|
73879179|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0102|TWO_SIDED|95.0|-3.61|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.49|-3.61|0.0102
73879180|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.81||0.0098|TWO_SIDED|95.0|-3.69|-0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.51|-3.69|0.0098
73879181|NCT03192176|147297610|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.18|-1.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.98|-5.18|<0.0001
74009917|NCT00139776|147570824|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical component summary||||<0.0001
74092551|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
74009918|NCT00139776|147570824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0301||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental component summary||||0.0301
74092552|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
73879182|NCT03192176|147297610|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-4.89|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.70|-4.89|<0.0001
74009919|NCT00674583|147570826|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the two-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Menjugate Group) in the percentages of subjects with vaccine response to rSBA-MenC is greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in percentage|-0.88|||||TWO_SIDED|95.0|-5.25|5.75||||||To demonstrate the non-inferiority of the Nimenrix group compared to the Menjugate group, two-sided standardized asymptotic 95% confidence interval (CI) for the groups difference \[Nimenrix group minus Menjugate group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||5.75|-5.25|
74009920|NCT02752035|147570841|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.523|TWO_SIDED|95.0|0.57|1.329|||Log Rank||Based on Cox proportional hazards model.|Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.||1.329|0.570|0.523
74009921|NCT02752035|147570842|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.787|TWO_SIDED|95.0|0.635|1.393|||Log Rank||Based on Cox proportional hazards model.|Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.||1.393|0.635|0.787
74009922|NCT02752035|147570844|SUPERIORITY||Treatment Difference|8.2||||0.249|TWO_SIDED|95.0|-6.5|23.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||23.0|-6.5|0.249
74009923|NCT02752035|147570845|SUPERIORITY||Treatment Difference|33.3|||<|0.001|TWO_SIDED|95.0|16.6|50.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||50.0|16.6|<0.001
74009924|NCT02752035|147570846|SUPERIORITY||Treatment Difference|8.5||||0.049|TWO_SIDED|95.0|-0.1|17.1||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||17.1|-0.1|0.049
74009925|NCT02752035|147570847|SUPERIORITY||Treatment Difference|16.7||||0.032|TWO_SIDED|95.0|1.1|32.4||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||32.4|1.1|0.032
74009926|NCT02752035|147570848|SUPERIORITY||Treatment Difference|-9.0||||0.34|TWO_SIDED|95.0|-29.8|11.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||11.0|-29.8|0.340
74009927|NCT02752035|147570849|SUPERIORITY||Treatment Difference|50.0||||0.221|TWO_SIDED|95.0|-61.0|100.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||100.0|-61.0|0.221
74009928|NCT02752035|147570850|SUPERIORITY||Hazard Ratio (HR)|0.844||||0.592|TWO_SIDED|95.0|0.451|1.58|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|||1.580|0.451|0.592
74009929|NCT02752035|147570851|SUPERIORITY||Hazard Ratio (HR)|0.573||||0.3|TWO_SIDED|95.0|0.198|1.658|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CR/CRh.||1.658|0.198|0.300
74009930|NCT02752035|147570851|SUPERIORITY||Hazard Ratio (HR)|0.411||||0.171|TWO_SIDED|95.0|0.113|1.504|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CR.||1.504|0.113|0.171
74009931|NCT02752035|147570851|SUPERIORITY||Hazard Ratio (HR)|0.691||||0.383|TWO_SIDED|95.0|0.295|1.62|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CRc||1.620|0.295|0.383
74009932|NCT02752035|147570851|SUPERIORITY||Hazard Ratio (HR)|999.0||||0.998|TWO_SIDED|95.0|0.001||Upper limit of 95% confidence interval was not estimable due to insufficient number of participants.||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CRh.|||0.001|0.998
74009933|NCT02752035|147570851|SUPERIORITY||Hazard Ratio (HR)|0.628||||0.174|TWO_SIDED|95.0|0.321|1.229|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of response.||1.229|0.321|0.174
74009934|NCT02752035|147570852|SUPERIORITY||Least square mean difference|0.5||||0.56|TWO_SIDED|95.0|-1.1|2.0|||ANCOVA|Using analysis of covariance including treatment, age group per IRT and baseline score as covariate.|Least square mean difference and P-value were calculated using AZA as reference.|||2.0|-1.1|0.560
74009935|NCT04754802|147570861|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|2.42||0.5063|TWO_SIDED|95.0|-3.2|6.4|||ANCOVA|||||6.4|-3.2|.5063
74009936|NCT04754802|147570862|SUPERIORITY||Other|-0.015||||0.8077|TWO_SIDED|95.0|-0.137|0.107|||Wald Normal Approximation (Z)|Wald Normal Approximation (Z) for difference between two proportions||||0.107|-0.137|.8077
74009937|NCT04451161|147570863|SUPERIORITY|||||||0.591||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student beginning of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.591
74040540|NCT00830960|147633157|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-171.0|||<|0.0001|TWO_SIDED|95.0|-216.0|-125.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-125|-216|<0.0001
74040541|NCT00830960|147633157|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-212.0|||<|0.0001|TWO_SIDED|95.0|-259.0|-167.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-167|-259|<0.0001
74009938|NCT04451161|147570863|SUPERIORITY|||||||0.032||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.032
74009939|NCT04451161|147570863|SUPERIORITY|||||||0.054||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the sustainment phase.|Chi-squared|||One of the primary TF-CBT adoption outcomes (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student at the end of the sustainment phase, or they did not. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.054
74009940|NCT04451161|147570863|SUPERIORITY|||||||0.98||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student at the beginning of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.98
74009941|NCT04451161|147570863|SUPERIORITY|||||||0.068||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.068
74009942|NCT04451161|147570863|SUPERIORITY|||||||0.165||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the sustainment phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.165
74009943|NCT04451161|147570863|SUPERIORITY|||||||0.191||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.191
74009944|NCT04451161|147570863|SUPERIORITY|||||||0.86||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student at the end of the sustainment phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.86
74009945|NCT04451161|147570864|SUPERIORITY||Slope|3.425|STANDARD_ERROR_OF_MEAN|2.783||0.22|TWO_SIDED|95.0|-2.064|8.915||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.|Mixed Models Analysis|||We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).||8.915|-2.064|0.22
74009946|NCT04451161|147570864|SUPERIORITY||Slope|4.97|STANDARD_ERROR_OF_MEAN|2.774||0.075|TWO_SIDED|95.0|-0.502|10.443||Mixed model analysis was used (the students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.|Mixed Models Analysis|||We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).||10.443|-.502|0.075
74040542|NCT00830960|147633158|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-119.0|||<|0.0001|TWO_SIDED|95.0|-166.0|-73.0||"P-value for 30 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|LS Mean Difference in PRU|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-166|<0.0001
74040543|NCT00830960|147633158|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-113.0|||<|0.0001|TWO_SIDED|95.0|-154.0|-73.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-154|<0.0001
74040544|NCT00830960|147633158|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-85.0|||<|0.0001|TWO_SIDED|95.0|-121.0|-48.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-48|-121|<0.0001
73879183|NCT03192176|147297610|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|-5.61|-2.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.37|-5.61|<0.0001
73879184|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.82||0.0021|TWO_SIDED|95.0|-4.17|-0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.93|-4.17|0.0021
73879185|NCT03192176|147297610|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.81||0.0001|TWO_SIDED|95.0|-4.71|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.52|-4.71|0.0001
73879186|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.002|TWO_SIDED|95.0|-4.11|-0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.93|-4.11|0.0020
73879187|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.76||0.021|TWO_SIDED|95.0|-3.27|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.27|-3.27|0.0210
73879188|NCT03192176|147297610|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-4.59|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.58|-4.59|<0.0001
73879189|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.88|STANDARD_ERROR_OF_MEAN|0.77||0.0003|TWO_SIDED|95.0|-4.34|-1.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.33|-4.34|0.0003
73879190|NCT03192176|147297610|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-5.29|-2.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.23|-5.29|<0.0001
74040545|NCT00830960|147633158|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-35.0||||0.0647|TWO_SIDED|95.0|-72.0|2.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||2|-72|0.0647
74040546|NCT00830960|147633158|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-100.0|||<|0.0001|TWO_SIDED|95.0|-143.0|-57.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-57|-143|<0.0001
74040547|NCT00830960|147633159|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|15.0||||0.0072|TWO_SIDED|95.0|4.0|27.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||27|4|0.0072
74009947|NCT04451161|147570865|SUPERIORITY||Slope|1.024|STANDARD_ERROR_OF_MEAN|0.952||0.284|TWO_SIDED|95.0|-0.855|2.904||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.|Mixed Models Analysis|||We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).||2.904|-.855|0.284
74040548|NCT00830960|147633159|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|9.0||||0.0647|TWO_SIDED|95.0|-1.0|18.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||18|-1|0.0647
73879191|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.77||0.0023|TWO_SIDED|95.0|-3.91|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.86|-3.91|0.0023
73879192|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.76||0.0004|TWO_SIDED|95.0|-4.25|-1.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.24|-4.25|0.0004
73887957|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|32.2||||0.2277|TWO_SIDED|95.0|-20.3|84.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||84.7|-20.3|0.2277
73879193|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.76||0.0036|TWO_SIDED|95.0|-3.73|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.74|-3.73|0.0036
73879194|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.77||0.0195|TWO_SIDED|95.0|-3.33|-0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.29|-3.33|0.0195
73879195|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.21|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.17|-4.21|0.0006
73879196|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.77||0.0004|TWO_SIDED|95.0|-4.32|-1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.27|-4.32|0.0004
73879197|NCT03192176|147297610|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|-5.01|-1.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.92|-5.01|<0.0001
73879198|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.78||0.0061|TWO_SIDED|95.0|-3.71|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.62|-3.71|0.0061
73879199|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.19|-1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.14|-4.19|0.0006
73879200|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.77||0.003|TWO_SIDED|95.0|-3.81|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.78|-3.81|0.0030
73887958|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|173.1|||<|0.0001|TWO_SIDED|95.0|120.5|225.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||225.6|120.5|<0.0001
74009948|NCT04451161|147570865|SUPERIORITY||Slope|1.908|STANDARD_ERROR_OF_MEAN|0.951||0.046|TWO_SIDED|95.0|0.03|3.786||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.|Mixed Models Analysis|||We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).||3.786|.03|.046
74009949|NCT00073528|147570896|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.019|TWO_SIDED|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio wase based on the log-rank test.|||0.96|0.53|0.019
74009950|NCT00073528|147570897|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.019|TWO_SIDED|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio was based on the log-rank test.|||0.96|0.53|0.019
74009951|NCT02887404|147570930|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.92|TWO_SIDED|95.0|-6.0|6.0|||t-test, 2 sided|||||6|-6|0.92
74009952|NCT02887404|147570931|NON_INFERIORITY|Delta: 15. The significance level for non-inferiority was 0.025|Median Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-21.0|3.0|||Hodges-Lehmann estimator|||||3|-21|<0.001
74009953|NCT02887404|147570931|SUPERIORITY||Median Difference (Final Values)|-9.0||||0.175|TWO_SIDED|97.5|-23.0|5.0||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice.|Hodges-Lehmann estimator|||||5|-23|0.175
74009954|NCT02887404|147570932|NON_INFERIORITY|Delta: 1 The significance level for the non-inferiority test was 0.025.|Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.8|1.0||This is a joint hypothesis testing. We tested non-inferiority on both secondary outcomes. If both showed significant non-inferiority, we tested superiority on both outcomes.|Regression, Linear|||||1|-0.8|<0.001
74009955|NCT02887404|147570932|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.094|TWO_SIDED|97.5|-0.8|0.1||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Regression, Linear|||||0.1|-0.8|0.094
74009956|NCT02887404|147570950|NON_INFERIORITY|Delta: 9; significance level was 0.025|Median Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.1|||Wilcoxon (Mann-Whitney)|||||0.1|-0.3|<0.001
74009957|NCT02887404|147570950|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.171|TWO_SIDED|97.5|-0.3|0.1||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Wilcoxon sum rank test|||||0.1|-0.3|0.171
74009958|NCT02887404|147570951|NON_INFERIORITY|Delta: 1 significance level: 0.025|Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-1.0|-0.1|||Regression, Linear||||The superiority test (this is a joint-hypothesis testing) showed a mean difference of -0.5 between treatment and control group with 97.5% CI of (-1.0, 0.0) and p-value of 0.025. The significance level was 0.025.|-0.1|-1.0|<0.001
73879201|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.78||0.0383|TWO_SIDED|95.0|-3.17|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.09|-3.17|0.0383
74009959|NCT02887404|147570951|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.025|TWO_SIDED|97.5|-1.0|0.0||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Regression, Linear|||||0.0|-1.0|0.025
74040549|NCT00830960|147633159|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|11.0||||0.0054|TWO_SIDED|95.0|3.0|19.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||19|3|0.0054
74040550|NCT00830960|147633159|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|51.0|||<|0.0001|TWO_SIDED|95.0|36.0|66.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||66|36|<0.0001
74092553|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74009960|NCT00117598|147570952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.25|0.63|||Log Rank||HR from a cox model adjusted for baseline stratification factors|Two null hypotheses (Ho) tested: 1. PFS distributions for temsirolimus 175/75 mg and investigator's choice treatment groups are identical. 2. PFS distributions for temsirolimus 175/25 mg and investigator's choice treatment groups are identical. Alternative hypothesis (Ha) for each test was that PFS distributions differed.||0.63|0.25|<0.0001
74009961|NCT00117598|147570952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.26|0.65|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.65|0.26|<0.0001
74009962|NCT00117598|147570953|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Fisher Exact|||||||0.0019
74009963|NCT00117598|147570953|SUPERIORITY_OR_OTHER|||||||0.6179|TWO_SIDED||||||Fisher Exact|||||||0.6179
74009964|NCT00117598|147570954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.3053|TWO_SIDED|95.0|0.46|1.28|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.28|0.46|0.3053
74009965|NCT00117598|147570954|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.9515|TWO_SIDED|95.0|0.6|1.62|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.62|0.60|0.9515
74009966|NCT00117598|147570955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.14|9.01|||||HR from a cox model adjusted for baseline stratification factors|||9.01|0.14|
74009967|NCT00117598|147570955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.1|13.3|||||HR from a cox model adjusted for baseline stratification factors|||13.3|0.10|
74009968|NCT00117598|147570957|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.23|0.56|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.56|0.23|<0.0001
74009969|NCT00117598|147570957|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.26|0.6|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.60|0.26|<0.0001
74009970|NCT00117598|147570958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39||||0.0004|TWO_SIDED|95.0|0.23|0.67|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.67|0.23|0.0004
74009971|NCT00117598|147570958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0712|TWO_SIDED|95.0|0.4|1.04|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.04|0.40|0.0712
74009972|NCT04688775|147570960|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5048|TWO_SIDED|95.0|-1.3|2.6|||Mixed Models Repeated Measures|||Change From Baseline in the Number of Weekly Attacks: Eptinezumab vs. Placebo||2.6|-1.3|0.5048
74009973|NCT04688775|147570965|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.0772|TWO_SIDED|95.0|0.96|2.17|||Regression, Cox|||||2.17|0.96|0.0772
74009974|NCT04391036|147571016|SUPERIORITY||||||>|0.99|||||||McNemar|||This was a paired analysis comparing successful insertion of the high and low Eudragit® Films. The McNemar's test statistic is based on the discordant pairs (number of participants with high successful, low unsuccessful versus low successful, high unsuccessful).||||>.99
74009975|NCT04391036|147571017|SUPERIORITY|||||||0.45||||||This was a paired analysis comparing difficulty of insertion of the high and low Eudragit® Films. The McNemar's test is based on discordant pairs (high was not difficult, low was difficult versus low was not difficult, high was difficult).|McNemar|||||||.45
74009976|NCT04391036|147571018|SUPERIORITY|||||||0.26|||||||Fisher Exact|This was an overall Fisher's exact test so the analysis applies to all categories.||||||.26
74009977|NCT02573870|147571020|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p-values were not presented as non-inferiority was assessed by confidence interval (CI).|Mean Difference (Final Values)|-2.245|||||TWO_SIDED|95.0|-6.153|1.663|||||Treatment difference is calculated as active minus placebo and the non-inferiority bound was 10 bpm for Day 42|||1.663|-6.153|
74009978|NCT01206062|147571024|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.64|0.89|||Regression, Cox|||||0.89|0.64|<0.001
74009979|NCT01206062|147571025|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.003|TWO_SIDED|95.0|0.6|0.9|||Regression, Cox|||||0.90|0.60|0.003
74009980|NCT01206062|147571026|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.58|TWO_SIDED|95.0|0.34|1.83|||Regression, Cox|||||1.83|0.34|0.58
74009981|NCT01206062|147571028|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.1|TWO_SIDED|95.0|0.67|1.04|||Regression, Cox|||||1.04|0.67|.10
74009982|NCT01101438|147571107|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.93|TWO_SIDED|95.0|0.84|1.21|||Log Rank|||||1.21|0.84|0.93
74009983|NCT01101438|147571108|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.87|1.17|||Log Rank|||||1.17|0.87|0.94
74009984|NCT01101438|147571109|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.88|TWO_SIDED|95.0|0.83|1.24|||Log Rank|||||1.24|0.83|0.88
74009985|NCT01825057|147571142|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.0009|TWO_SIDED|||||adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner Method|Kruskal-Wallis|degrees of freedom = 2|mean difference = Order One - Do One|||||0.0009
74009986|NCT01825057|147571142|SUPERIORITY||Median Difference (Final Values)|19.7|||<|0.0001|TWO_SIDED|||||Adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner Method|Kruskal-Wallis|degrees of freedom = 2|mean difference = Order One - See One|||||<0.0001
74009987|NCT01825057|147571142|SUPERIORITY||Mean Difference (Final Values)|2.178||||0.4983|TWO_SIDED||||||Kruskal-Wallis|degrees of freedom = 2|mean difference = Do One - See One|||||0.4983
74009988|NCT01825057|147571143|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.0217|TWO_SIDED|||||Adjusted for multiple comparisons using the Dwass, Steel, Critchlow-Fligner Method.|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.0217
74009989|NCT01825057|147571143|SUPERIORITY|mean difference is Order One - See One|Mean Difference (Final Values)|1.22||||0.0126|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis|||||||0.0126
74009990|NCT01825057|147571143|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.4231|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference is Do One - See One|||||0.4231
74009991|NCT01825057|147571144|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.0091|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.0091
74009992|NCT01825057|147571144|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.0196|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Order One - See One|||||0.0196
74009993|NCT01825057|147571144|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.2832|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.2832
74009994|NCT01825057|147571145|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.1566|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.1566
74009995|NCT01825057|147571145|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.0982|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Order One - See One|||||0.0982
74009996|NCT01825057|147571145|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.6631|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.6631
74009997|NCT01825057|147571146|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.1327|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||.1327
74009998|NCT01825057|147571146|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.4097|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||||mean difference = Order One - See One|||0.4097
74009999|NCT01825057|147571146|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.8779|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.8779
74010000|NCT04746833|147571157|EQUIVALENCE|mean of Summit will be equal to mean of control||||||0.91|||||||t-test, 2 sided|||||||.91
74010001|NCT04746833|147571158|OTHER|||||||||||||||||descriptive statistic of system use|simple descriptive findings for evaluation of feasibility of the Sumit app|||
74010002|NCT04746833|147571159|EQUIVALENCE|standard null hypothesis of no difference between groups||||||0.5|||||||t-test, 2 sided|||||||.50
74010003|NCT02015442|147571160|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Baseline vs. treatment period||||0.390
74010004|NCT02015442|147571160|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||Baseline vs treatment||||0.204
74010005|NCT02015442|147571161|SUPERIORITY|||||||0.001||||||calculated|t-test, 2 sided|||Baseline vs treatment||||0.001
74010006|NCT02015442|147571161|SUPERIORITY|||||||0.244|||||||t-test, 2 sided|||Baseline vs treatment||||0.244
74010007|NCT02015442|147571161|SUPERIORITY|||||||0.244|||||||ANOVA|||||||0.244
74010008|NCT00290290|147571162|SUPERIORITY_OR_OTHER||Relative Risk|0.59||||0.004|TWO_SIDED|95.0|0.41|0.85|||Log Rank|||The average baseline rate of surgical-site infection at the six participating hospitals was 14% after clean-contaminated surgery with povidone-iodine skin preparation, and we estimated that substituting chlorhexidine-alcohol for povidone-iodine would reduce this rate to 7%. Therefore, we planned to enroll approximately 430 patients in each study group who could be evaluated in order for the study to have 90% power to detect a significant difference in the rates of surgical-site infection.||0.85|0.41|0.004
74010009|NCT04013789|147571163|NON_INFERIORITY|The noninferiority margin was set at 0.05.|Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.006|||ONE_SIDED|95.0||0.03|||Mixed Effects Repeated Measures Model||DACP FreshTech minus DACP|||0.03||
74010010|NCT05714982|147571164|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
74010011|NCT05714982|147571164|SUPERIORITY|||||||0.78|||||||General linear model|||||||.78
74010012|NCT05714982|147571165|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
74010013|NCT05714982|147571165|SUPERIORITY|||||||0.66|||||||General linear model|||||||.66
74010014|NCT05714982|147571166|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
74010015|NCT05714982|147571166|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
74010016|NCT05714982|147571167|SUPERIORITY|||||||0.001|||||||General linear model|||||||.001
74010017|NCT05714982|147571167|SUPERIORITY|||||||0.95|||||||General linear model|||||||.95
74010018|NCT05714982|147571168|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
74010019|NCT05714982|147571168|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
74010020|NCT05714982|147571169|SUPERIORITY||||||<|0.0001|||||||General linear model|||||||<.0001
74010021|NCT05714982|147571169|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
74010022|NCT05714982|147571170|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
74010023|NCT05714982|147571170|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
74092554|NCT02504671|147737905|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
74092555|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092556|NCT02504671|147737905|OTHER||Difference|29.7|||||TWO_SIDED|95.0|13.8|45.7|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||45.7|13.8|
74092557|NCT02504671|147737905|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
74092558|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092559|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092560|NCT02504671|147737905|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
74092561|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092562|NCT02504671|147737905|OTHER||Difference|35.1|||||TWO_SIDED|95.0|18.7|51.6|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||51.6|18.7|
74092563|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092564|NCT02504671|147737905|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
74092565|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092566|NCT02504671|147737905|OTHER||Difference|51.4|||||TWO_SIDED|95.0|37.3|70.9|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.9|37.3|
74092567|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092568|NCT02504671|147737905|OTHER||Difference|32.4|||||TWO_SIDED|95.0|16.2|48.7|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.7|16.2|
74092569|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092570|NCT02504671|147737905|OTHER||Difference|21.6|||||TWO_SIDED|95.0|8.4|34.9|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.9|8.4|
73879202|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.79||0.0004|TWO_SIDED|95.0|-4.33|-1.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.24|-4.33|0.0004
74092571|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092572|NCT02504671|147737905|OTHER||Difference|48.6|||||TWO_SIDED|95.0|31.7|65.6|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.6|31.7|
73879203|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.79||0.0011|TWO_SIDED|95.0|-4.14|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.04|-4.14|0.0011
74092573|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092574|NCT02504671|147737905|OTHER||Difference|24.3|||||TWO_SIDED|95.0|9.1|39.6|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||39.6|9.1|
74092575|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092576|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092577|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74092578|NCT02504671|147737905|OTHER||Difference|40.5|||||TWO_SIDED|95.0|23.7|57.3|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.3|23.7|
74092579|NCT02504671|147737905|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
74040551|NCT00830960|147633159|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|36.0|||<|0.0001|TWO_SIDED|95.0|23.0|48.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||48|23|<0.0001
74040552|NCT00830960|147633159|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|49.0|||<|0.0001|TWO_SIDED|95.0|36.0|61.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||61|36|<0.0001
74040553|NCT00830960|147633159|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|62.0|||<|0.0001|TWO_SIDED|95.0|47.0|76.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||76|47|<0.0001
74040554|NCT00830960|147633159|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|48.0|||<|0.0001|TWO_SIDED|95.0|36.0|59.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||59|36|<0.0001
74040555|NCT00830960|147633159|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|56.0|||<|0.0001|TWO_SIDED|95.0|44.0|68.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||68|44|<0.0001
74040556|NCT00830960|147633160|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|38.0|||<|0.0001|TWO_SIDED|95.0|27.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||50|27|<0.0001
74040557|NCT00830960|147633160|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|TWO_SIDED|95.0|21.0|42.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||42|21|<0.0001
74040558|NCT00830960|147633160|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|17.0||||0.0026|TWO_SIDED|95.0|6.0|28.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||28|6|0.0026
74040559|NCT00830960|147633160|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|37.0|||<|0.0001|TWO_SIDED|95.0|24.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||50|24|<0.0001
74040560|NCT00830960|147633160|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|35.0||||0.0001|TWO_SIDED|95.0|18.0|52.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||52|18|0.0001
74040561|NCT00830960|147633160|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|28.0||||0.0005|TWO_SIDED|95.0|13.0|44.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||44|13|0.0005
74092580|NCT02504671|147737905|OTHER||Difference|24.3|||||TWO_SIDED|95.0|9.1|39.6|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||39.6|9.1|
74010024|NCT05714982|147571171|SUPERIORITY|||||||0.03|||||||General linear model|||||||.03
74010025|NCT05714982|147571171|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
74010026|NCT05714982|147571172|SUPERIORITY|||||||0.61|||||||General linear model|||||||.61
74010027|NCT05714982|147571172|SUPERIORITY|||||||0.68|||||||General linear model|||||||.68
74010028|NCT05714982|147571173|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
74010029|NCT05714982|147571173|SUPERIORITY|||||||0.5|||||||General linear model|||||||.5
74010030|NCT05714982|147571174|SUPERIORITY|||||||0.001|||||||General linear model|||||||.001
74010031|NCT05714982|147571174|SUPERIORITY|||||||0.9|||||||General linear model|||||||.9
74010032|NCT05714982|147571175|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.73|1.2||||||||1.2|.73|
74010033|NCT05714982|147571175|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.69|1.2||||||||1.2|.69|
74010034|NCT05714982|147571176|SUPERIORITY||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.3|0.9||||||||.9|.3|
73879204|NCT03192176|147297610|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-5.07|-1.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.93|-5.07|<0.0001
74040562|NCT00830960|147633160|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|11.0||||0.1898|TWO_SIDED|95.0|-5.0|27.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||27|-5|0.1898
74040563|NCT00830960|147633160|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|TWO_SIDED|95.0|18.0|45.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||45|18|<0.0001
74040564|NCT00830960|147633162|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-110.0|||<|0.0001|TWO_SIDED|95.0|-143.0|-76.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-76|-143|<0.0001
74040565|NCT00830960|147633162|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-92.0|||<|0.0001|TWO_SIDED|95.0|-123.0|-60.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-60|-123|<0.0001
74040566|NCT00830960|147633162|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-51.0||||0.002|TWO_SIDED|95.0|-83.0|-19.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-19|-83|0.0020
74040567|NCT00830960|147633169|SUPERIORITY_OR_OTHER|||||||0.255||95.0|||||Fisher Exact|||||||0.255
74040568|NCT00830960|147633169|SUPERIORITY_OR_OTHER|||||||0.427||95.0|||||Fisher Exact|||||||0.427
74040569|NCT00830960|147633169|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Fisher Exact|||||||0.683
74040570|NCT00830960|147633169|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Fisher Exact|||||||0.034
74040571|NCT00507416|147633203|SUPERIORITY_OR_OTHER|||||||0.458||||||The global difference among arms was based on the Wald test.|Wald test|||||||0.458
74040572|NCT02157506|147633221|SUPERIORITY||||||=|0.0059|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||=0.0059
74040573|NCT02157506|147633221|SUPERIORITY||||||=|0.0001|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0001
74040574|NCT02157506|147633221|SUPERIORITY||||||=|0.0062|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0062
74040575|NCT02157506|147633221|SUPERIORITY||||||=|0.0086|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0086
73887959|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|151.7|||<|0.0001|TWO_SIDED|95.0|99.1|204.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||204.2|99.1|<0.0001
74040576|NCT02157506|147633222|SUPERIORITY||||||=|0.0076|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0076
74040577|NCT02157506|147633222|SUPERIORITY||||||=|0.0052|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0052
74040578|NCT02157506|147633222|SUPERIORITY||||||=|0.1064|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1064
74040579|NCT02157506|147633222|SUPERIORITY||||||=|0.1151|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1151
74040580|NCT02157506|147633223|SUPERIORITY||||||=|0.4241|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4241
74040581|NCT02157506|147633223|SUPERIORITY||||||=|0.4035|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4035
74040582|NCT02157506|147633223|SUPERIORITY||||||=|0.8308|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8308
74040583|NCT02157506|147633223|SUPERIORITY||||||=|0.118|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1180
74040584|NCT02157506|147633224|SUPERIORITY||||||=|0.0048|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0048
74040585|NCT02157506|147633224|SUPERIORITY||||||=|0.0022|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0022
74040586|NCT02157506|147633224|SUPERIORITY||||||=|0.0045|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0045
74040587|NCT02157506|147633224|SUPERIORITY||||||=|0.0294|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0294
74040588|NCT02157506|147633225|SUPERIORITY||||||=|0.2022|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2022
74010035|NCT05714982|147571176|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||||1.7|.6|
74010036|NCT05714982|147571177|SUPERIORITY|||||||0.02|||||||General linear model|||||||.02
74010037|NCT05714982|147571177|SUPERIORITY|||||||0.5|||||||General linear model|||||||.5
74010038|NCT05714982|147571178|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
74010039|NCT05714982|147571178|SUPERIORITY|||||||0.004|||||||General linear model|||||||.004
74010040|NCT05714982|147571179|SUPERIORITY|||||||0.3|||||||General linear model|||||||0.3
74010041|NCT05714982|147571179|SUPERIORITY|||||||0.5|||||||General linear model|||||||0.5
74010042|NCT05714982|147571180|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.99|2.1||||||||2.1|.99|
74010043|NCT05714982|147571180|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||||2.6|1.2|
74010044|NCT00549939|147571181|SUPERIORITY_OR_OTHER|||||||1||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1.00
74040589|NCT02157506|147633225|SUPERIORITY||||||=|0.0658|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0658
74040590|NCT02157506|147633225|SUPERIORITY||||||=|0.0741|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0741
74010045|NCT00549939|147571181|SUPERIORITY_OR_OTHER|||||||0.91||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.91
74010046|NCT00549939|147571183|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-6.2|STANDARD_ERROR_OF_MEAN|3.8||0.104|TWO_SIDED|95.0|-13.72|1.29||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."||1.29|-13.72|0.1040
74010047|NCT00549939|147571183|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-7.1|STANDARD_ERROR_OF_MEAN|3.77||0.104|TWO_SIDED|95.0|-14.51|0.39||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||0.39|-14.51|0.1040
74040591|NCT02157506|147633225|SUPERIORITY||||||=|0.0497|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0497
74040592|NCT02157506|147633226|SUPERIORITY||||||=|0.1842|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1842
74040593|NCT02157506|147633226|SUPERIORITY||||||=|0.3328|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.3328
74040594|NCT02157506|147633226|SUPERIORITY||||||=|0.1465|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1465
74010048|NCT00549939|147571184|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-11.4|STANDARD_ERROR_OF_MEAN|7.54||0.1338|TWO_SIDED|95.0|-26.27|3.53||P-values was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."||3.53|-26.27|0.1338
74010049|NCT00549939|147571184|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-14.3|STANDARD_ERROR_OF_MEAN|7.48||0.1152|TWO_SIDED|95.0|-29.1|0.47||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||0.47|-29.10|0.1152
74010050|NCT00549939|147571186|SUPERIORITY_OR_OTHER|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor compliance was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor compliance as covariate."||||0.7889
74010051|NCT00549939|147571186|SUPERIORITY_OR_OTHER|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||||0.7889
74040595|NCT02157506|147633226|SUPERIORITY||||||=|0.2799|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2799
74010052|NCT03634397|147571208|OTHER||Mean Difference (Final Values)|5.73|||<|0.05|TWO_SIDED|95.0|2.31|9.14||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear||The delta values of the outcome from baseline 2 to post-treatment 1 were directly modeled using linear regression with adjustment for age, female sex, and the hemisphere affected by the stroke.|||9.14|2.31|<.05
74010053|NCT03634397|147571210|OTHER|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Mean Difference (Final Values)|0.83|||<|0.05|TWO_SIDED|95.0|-2.58|4.24||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.||||4.24|-2.58|<.05
74010054|NCT03634397|147571211|OTHER|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Median Difference (Final Values)|1.12|||<|0.05|TWO_SIDED|95.0|-2.29|4.53||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|||4.53|-2.29|<.05
74010055|NCT05197049|147571215|SUPERIORITY||Adjusted treatment difference:percentage|34.9|||<|0.001|TWO_SIDED|95.0|25.1|44.6|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||44.6|25.1|< 0.001
73879205|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0055|TWO_SIDED|95.0|-3.8|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.66|-3.80|0.0055
73879206|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.79||0.0014|TWO_SIDED|95.0|-4.09|-0.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.99|-4.09|0.0014
73879207|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.78||0.004|TWO_SIDED|95.0|-3.8|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.73|-3.80|0.0040
73879208|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.78||0.1502|TWO_SIDED|95.0|-2.68|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.41|-2.68|0.1502
73879209|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0057|TWO_SIDED|95.0|-3.74|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.64|-3.74|0.0057
73879210|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0054|TWO_SIDED|95.0|-3.76|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.66|-3.76|0.0054
73879211|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.8||0.0006|TWO_SIDED|95.0|-4.38|-1.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.22|-4.38|0.0006
73879212|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.0412|TWO_SIDED|95.0|-3.21|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.07|-3.21|0.0412
73879213|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0054|TWO_SIDED|95.0|-3.76|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.66|-3.76|0.0054
73879214|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0167|TWO_SIDED|95.0|-3.43|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.34|-3.43|0.0167
73887960|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|129.8|||<|0.0001|TWO_SIDED|95.0|77.2|182.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||182.3|77.2|<0.0001
74010056|NCT05197049|147571216|SUPERIORITY||Adjusted treatment difference:percentage|19.9|||<|0.001|TWO_SIDED|95.0|10.2|29.6|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||29.6|10.2|< 0.001
74010057|NCT05197049|147571217|SUPERIORITY||Adjusted treatment difference:percentage|37.0|||<|0.001|TWO_SIDED|95.0|25.6|48.4|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||48.4|25.6|< 0.001
74010058|NCT05197049|147571217|SUPERIORITY||Adjusted treatment difference:percentage|39.3|||<|0.001|TWO_SIDED|95.0|28.0|50.7|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||50.7|28.0|< 0.001
74010059|NCT05197049|147571218|SUPERIORITY||Adjusted treatment difference:percentage|32.1|||<|0.001|TWO_SIDED|95.0|22.9|41.2|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||41.2|22.9|< 0.001
74040596|NCT02157506|147633227|SUPERIORITY||||||=|0.2499|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2499
74040597|NCT02157506|147633227|SUPERIORITY||||||=|0.8281|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8281
74040598|NCT02157506|147633227|SUPERIORITY||||||=|0.4121|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4121
74040599|NCT02157506|147633227|SUPERIORITY||||||=|0.8592|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8592
74040600|NCT02157506|147633228|SUPERIORITY||||||=|0.1391|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1391
74040601|NCT02157506|147633228|SUPERIORITY||||||=|0.1724|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1724
74010060|NCT05197049|147571219|SUPERIORITY||Adjusted treatment difference:percentage|40.3|||<|0.001|TWO_SIDED|95.0|29.9|50.7|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||50.7|29.9|< 0.001
74010061|NCT00309465|147571235|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||P-value for three dosing strategies in insulin glargine only group in fasting blood glucose achievement of 100-179 mg/dl range.|Chi-squared|||Comparison for Target Blood Glucose Achievement of 100-179 mg/dl||||0.332
74010062|NCT00309465|147571235|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||P value is for three strategies in insulin glargine plus bolus group for fasting blood glucose achievement of 100-179 mg/dl|Chi-squared|||Comparison for Target Achievement of blood glucose values of 100-179 mg/dl||||0.294
74092581|NCT02504671|147737905|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
74092582|NCT02504671|147737905|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
74092583|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092584|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092585|NCT02504671|147737906|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092586|NCT02504671|147737906|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092587|NCT02504671|147737906|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74092588|NCT02504671|147737906|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092589|NCT02504671|147737906|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092590|NCT02504671|147737906|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74092591|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092592|NCT02504671|147737906|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092593|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092594|NCT02504671|147737906|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092595|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092596|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092597|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092598|NCT02504671|147737906|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092599|NCT02504671|147737906|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092600|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092601|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74010063|NCT00309465|147571235|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||P value is for three strategies in insulin glargine only group for achievement of 80-249 mg/dl|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl||||0.162
74092602|NCT02504671|147737906|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092603|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092604|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092605|NCT02504671|147737906|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092606|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092607|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092608|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74040602|NCT02157506|147633228|SUPERIORITY||||||=|0.1245|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1245
74040603|NCT02157506|147633228|SUPERIORITY||||||=|0.169|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1690
74040604|NCT02157506|147633229|SUPERIORITY||||||=|0.4936|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4936
74040605|NCT02157506|147633229|SUPERIORITY||||||=|0.992|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.9920
74040606|NCT02157506|147633229|SUPERIORITY||||||=|0.2789|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2789
74040607|NCT02157506|147633229|SUPERIORITY||||||=|0.91|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.9100
74040608|NCT00493974|147633297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3876||95.0|||||Wilcoxon (Mann-Whitney)|||||||.3876
74040609|NCT00493974|147633298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6413||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6413
74040610|NCT00493974|147633299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6433||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6433
74040611|NCT00493974|147633300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0|||||Chi-squared|||||||0.63
74040612|NCT00493974|147633301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4957||95.0|||||t-test, 2 sided|||||||0.4957
74040613|NCT00493974|147633302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
74040614|NCT00493974|147633303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||t-test, 2 sided|||||||0.006
74040615|NCT02555657|147633304|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0574|TWO_SIDED|95.0|0.57|1.06|||Regression, Cox|||||1.06|0.57|0.0574
74040616|NCT02555657|147633305|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0728|TWO_SIDED|95.0|0.69|1.06|||Regression, Cox|||||1.06|0.69|0.0728
74040617|NCT02555657|147633306|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3802|TWO_SIDED|95.0|0.82|1.15|||Regression, Cox|||||1.15|0.82|0.3802
74040618|NCT02555657|147633307|SUPERIORITY||Difference in percentages|8.3||||0.0457|TWO_SIDED|95.0|-1.4|18.4|||Miettinen & Nurminen method|||||18.4|-1.4|0.0457
74040619|NCT02555657|147633308|SUPERIORITY||Difference in percentages|2.9||||0.1752|TWO_SIDED|95.0|-3.3|9.2|||Miettinen & Nurminen method|||||9.2|-3.3|0.1752
74040620|NCT02555657|147633309|SUPERIORITY||Difference in percentages|-1.0||||0.6629|TWO_SIDED|95.0|-5.9|3.8|||Miettinen & Nurminen method|||||3.8|-5.9|0.6629
74040621|NCT02555657|147633310|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.7936|TWO_SIDED|95.0|0.82|1.59|||Regression, Cox|||||1.59|0.82|0.7936
74040622|NCT02555657|147633311|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.9964|TWO_SIDED|95.0|1.08|1.68|||Regression, Cox|||||1.68|1.08|0.9964
74040623|NCT02555657|147633312|SUPERIORITY||Hazard Ratio (HR)|1.6||||1|TWO_SIDED|95.0|1.33|1.92|||Regression, Cox|||||1.92|1.33|1.0000
74040624|NCT02555657|147633316|SUPERIORITY||Difference in percentages|2.3||||0.3388|TWO_SIDED|95.0|-8.7|13.5|||Miettinen & Nurminen method|||||13.5|-8.7|0.3388
74040625|NCT02555657|147633317|SUPERIORITY||Difference in percentages|-1.6||||0.6701|TWO_SIDED|95.0|-8.6|5.5|||Miettinen & Nurminen method|||||5.5|-8.6|0.6701
74040626|NCT02555657|147633318|SUPERIORITY||Difference in percentages|-6.5||||0.9877|TWO_SIDED|95.0|-12.2|-0.8|||Miettinen & Nurminen method|||||-0.8|-12.2|0.9877
74040627|NCT01861054|147633362|OTHER|||||||0.3149||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Comparison on ALDH+ cells by ALDEFLUOR assay||||0.3149
74040628|NCT01861054|147633362|OTHER|||||||0.8148||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Comparison on CD44+/CD24- by flow citometry||||0.8148
74040629|NCT01861054|147633363|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho AKT Extent||||>0.9999
74040630|NCT01861054|147633363|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho-AKT Intensity||||>0.9999
74040631|NCT01861054|147633363|OTHER|||||||0.2245|||||||Wilcoxon (Mann-Whitney)|||AKT Extent||||0.2245
74040632|NCT01861054|147633363|OTHER|||||||0.5785|||||||Wilcoxon (Mann-Whitney)|||AKT Intensity||||0.5785
74040633|NCT01861054|147633363|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho-FAK Extent||||>0.9999
74040634|NCT01861054|147633363|OTHER|||||||0.3139|||||||Wilcoxon (Mann-Whitney)|||Phospho-FAK Intensity||||0.3139
74040635|NCT01861054|147633363|OTHER|||||||0.212|||||||Wilcoxon (Mann-Whitney)|||FAK Extent||||0.2120
74040636|NCT01861054|147633363|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||FAK Intensity||||>0.9999
74040637|NCT01861054|147633363|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||C-PTEN Extent||||>0.9999
74040638|NCT01861054|147633363|OTHER|||||||0.8728|||||||Wilcoxon (Mann-Whitney)|||C-PTEN Intensity||||0.8728
74040639|NCT01861054|147633363|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||D-PTEN Extent||||>0.9999
74040640|NCT01861054|147633363|OTHER|||||||0.8728|||||||Wilcoxon (Mann-Whitney)|||D-PTEN Intensity||||0.8728
74040641|NCT01861054|147633363|OTHER|||||||0.2265|||||||Wilcoxon (Mann-Whitney)|||CXCR1 Extent||||0.2265
74040642|NCT01861054|147633363|OTHER|||||||0.2403|||||||Wilcoxon (Mann-Whitney)|||CXCR1 Intensity||||0.2403
74040643|NCT01861054|147633364|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Interleukin 1 Beta||||>0.9999
74040644|NCT01861054|147633364|OTHER|||||||0.6945||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Interleukin 6||||0.6945
74040645|NCT01861054|147633364|OTHER|||||||0.9448||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Interleukin 8||||0.9448
74040646|NCT01861054|147633364|OTHER|||||||0.6292||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Tumor Necrosis Factor - alpha||||0.6292
74010064|NCT00309465|147571235|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P value is for three strategies in insulin glargine plus bolus group in achievement of fasting blood glucose value of 80-249 mg/dl.|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl.||||0.031
74010065|NCT02577406|147571250|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.2288|TWO_SIDED|95.0|0.67|1.1|||Stratified Log Rank||The hazard ratio was from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory|||1.10|0.67|0.2288
74010066|NCT02577406|147571251|SUPERIORITY||Odds Ratio (OR)|6.08|||<|0.0001|TWO_SIDED|95.0|3.32|11.14||p-value from a Cochran-Mantel-Haenszel test comparing the response rates between the AG-221 group and the combined CCR group with stratification factors of prior intensive therapy for AML and primary refractory status|Cochran-Mantel-Haenszel||Odds ratio from logistic regression|||11.14|3.32|<0.0001
74010067|NCT02577406|147571252|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.02|TWO_SIDED|95.0|0.55|0.95|||Stratified Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory status.|||0.95|0.55|0.0200
74010068|NCT02577406|147571258|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74010069|NCT02577406|147571259|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74010070|NCT02577406|147571260|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74040647|NCT01861054|147633364|OTHER|||||||0.2354||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Granulocyte Macrophage Colony Stm Factor||||0.2354
74040648|NCT01861054|147633364|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Vascular Endothelial Growth Factor||||>0.9999
74092609|NCT02504671|147737906|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74010071|NCT02577406|147571262|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.67|||Stratified Log Rank||The hazard ratio was from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory status|||0.67|0.41|<0.0001
74010072|NCT04033445|147571274|SUPERIORITY||Adjusted treatment difference|33.6|||<|0.001|TWO_SIDED|95.0|20.9|46.3|||Cochran-Mantel-Haenszel (CMH) chi-square||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||46.3|20.9|< 0.001
74010073|NCT04033445|147571274|SUPERIORITY||Adjusted treatment difference|33.1|||<|0.001|TWO_SIDED|95.0|20.8|45.4|||CMH chi-square test||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||45.4|20.8|< 0.001
74010074|NCT04033445|147571275|SUPERIORITY||Adjusted treatment difference|14.9|||<|0.001|TWO_SIDED|95.0|9.9|19.9|||CMH chi-square test||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||19.9|9.9|< 0.001
74010075|NCT04033445|147571276|SUPERIORITY||Adjusted treatment difference|25.2|||<|0.001|TWO_SIDED|95.0|16.4|33.9|||Cochran-Mantel-Haenszel||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||33.9|16.4|< 0.001
74010076|NCT04033445|147571276|SUPERIORITY||Adjusted treatment difference|29.5|||<|0.001|TWO_SIDED|95.0|20.9|38.1|||Cochran-Mantel-Haenszel||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||38.1|20.9|< 0.001
74010077|NCT01671111|147571323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.0560
74010078|NCT01671111|147571324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1232|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.1232
74010079|NCT01671111|147571325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1319|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.1319
74010080|NCT01671111|147571326|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8061|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.8061
74040649|NCT01861054|147633364|OTHER|||||||0.4719||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Basic Fibroblast Growth Factor||||0.4719
74092610|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092611|NCT02504671|147737906|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092612|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74010081|NCT01671111|147571327|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2297|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.2297
74010082|NCT01671111|147571328|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1248|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.1248
74010083|NCT00496730|147571348|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74010084|NCT00496730|147571349|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74010085|NCT00496730|147571350|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74040650|NCT01861054|147633365|OTHER|||||||0.0951|||||||Wilcoxon (Mann-Whitney)|||CD31 Extent||||0.0951
74040651|NCT01861054|147633365|OTHER|||||||0.1643|||||||Wilcoxon (Mann-Whitney)|||CD31 Intensity||||0.1643
74040652|NCT01861054|147633366|OTHER|||||||0.4183|||||||Wilcoxon (Mann-Whitney)|||P62 Extent||||0.4183
74040653|NCT01861054|147633366|OTHER|||||||0.3702|||||||Wilcoxon (Mann-Whitney)|||P62 Intensity||||0.3702
74040654|NCT01861054|147633371|OTHER|||||||0.6168||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Lymphocyte in WBC||||0.6168
74092613|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092614|NCT02504671|147737906|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74010086|NCT03962738|147571371|SUPERIORITY||Odds Ratio (OR)|3.46|||<|0.001|TWO_SIDED|95.0|2.17|5.54|||Regression, Logistic|||||5.54|2.17|<0.001
74010087|NCT03962738|147571372|SUPERIORITY||||||<|0.001|||||||Cochran-Armitage Trend Test|||||||<.001
74040655|NCT01861054|147633371|OTHER|||||||0.6168||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Total T cell in lymphocytes||||0.6168
74040656|NCT01861054|147633371|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||B cell in lymphocytes||||0.1453
74040657|NCT01861054|147633371|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||T-helper cell in lymphocytes||||0.1453
74040658|NCT01861054|147633371|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CTL in lymphocytes||||0.1453
74040659|NCT01861054|147633371|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||NKT cell in lymphocytes||||>0.9999
74040660|NCT01861054|147633371|OTHER|||||||0.7634||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||ADCC NK subsets in lymphocytes||||0.7634
74040661|NCT01861054|147633371|OTHER|||||||0.5487||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Regulatory NK subsets in lymphocytes||||0.5487
74040662|NCT01861054|147633371|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Exhausted NK subsets in lymphocytes||||>0.9999
74040663|NCT01861054|147633371|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD56-CD16+ NK subsets in lymphocytes||||>0.9999
74092615|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092616|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092617|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74010088|NCT03962738|147571373|SUPERIORITY||Odds Ratio (OR)|1.76||||0.037|TWO_SIDED|95.0|1.03|2.99|||Regression, Logistic|||||2.99|1.03|0.037
74040664|NCT01861054|147633371|OTHER|||||||0.1451||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD11b in PMNs - IL-8||||0.1451
74040665|NCT01861054|147633371|OTHER|||||||0.2779||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD18 in PMNs - IL-8||||0.2779
74040666|NCT01861054|147633371|OTHER|||||||0.1444||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD11b - IL-8||||0.1444
74040667|NCT01861054|147633371|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD66b - IL-8||||0.1453
74040668|NCT01861054|147633371|OTHER|||||||0.92||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD18 - IL-8||||0.9200
74040669|NCT01861054|147633371|OTHER|||||||0.2779||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD11b in PMNs - US||||0.2779
74040670|NCT01861054|147633371|OTHER|||||||0.6164||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD18 in PMNs - US||||0.6164
74040671|NCT01861054|147633371|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD11b - US||||>0.9999
74010089|NCT03962738|147571373|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.16|5.17|||Regression, Logistic|||||5.17|2.16|<0.001
74010090|NCT03962738|147571373|SUPERIORITY||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.89|4.62|||Regression, Logistic|||||4.62|1.89|<0.001
74010091|NCT03962738|147571374|SUPERIORITY||Odds Ratio (OR)|1.49||||0.197|TWO_SIDED|95.0|0.81|2.72|||Regression, Logistic|||||2.72|0.81|0.197
74040672|NCT01861054|147633371|OTHER|||||||0.2032||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD66b - US||||0.2032
74040673|NCT01861054|147633371|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD18 - US||||>0.9999
74040674|NCT01861054|147633371|OTHER|||||||0.525||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - IL-8||||0.5250
74040675|NCT01861054|147633371|OTHER|||||||0.6706||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - IL-8||||0.6706
74040676|NCT01861054|147633371|OTHER|||||||0.8312||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - IL-8||||0.8312
74040677|NCT01861054|147633371|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - IL-8||||0.3992
74092618|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
73879215|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.75||0.0533|TWO_SIDED|95.0|-2.94|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.02|-2.94|0.0533
73879216|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0065|TWO_SIDED|95.0|-3.54|-0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.58|-3.54|0.0065
73879217|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.76||0.0025|TWO_SIDED|95.0|-3.8|-0.82||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.82|-3.80|0.0025
73879218|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0005|TWO_SIDED|95.0|-4.22|-1.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.20|-4.22|0.0005
73879219|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.77||0.0541|TWO_SIDED|95.0|-2.99|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.03|-2.99|0.0541
73879220|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.76||0.0039|TWO_SIDED|95.0|-3.69|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.71|-3.69|0.0039
74092619|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092620|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092621|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
73879221|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.75||0.0245|TWO_SIDED|95.0|-3.18|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.22|-3.18|0.0245
73879222|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.78||0.0187|TWO_SIDED|95.0|-3.36|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.31|-3.36|0.0187
73879223|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.78||0.006|TWO_SIDED|95.0|-3.68|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.62|-3.68|0.0060
74010092|NCT03962738|147571374|SUPERIORITY||Odds Ratio (OR)|1.59||||0.044|TWO_SIDED|95.0|1.01|2.5|||Regression, Logistic|||||2.50|1.01|0.044
74010093|NCT03962738|147571374|SUPERIORITY||Odds Ratio (OR)|1.75||||0.023|TWO_SIDED|95.0|1.08|2.83|||Regression, Logistic|||||2.83|1.08|0.023
74010094|NCT03962738|147571375|SUPERIORITY||Odds Ratio (OR)|1.52||||0.268|TWO_SIDED|95.0|0.73|3.17|||Regression, Logistic|||||3.17|0.73|0.268
74010095|NCT03962738|147571375|SUPERIORITY||Odds Ratio (OR)|2.19||||0.006|TWO_SIDED|95.0|1.26|3.82|||Regression, Logistic|||||3.82|1.26|0.006
74010096|NCT03962738|147571375|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.001|TWO_SIDED|95.0|1.5|4.61|||Regression, Logistic|||||4.61|1.50|<0.001
74010097|NCT03962738|147571376|SUPERIORITY||Odds Ratio (OR)|1.26||||0.535|TWO_SIDED|95.0|0.61|2.58|||Regression, Logistic|||||2.58|0.61|0.535
74010098|NCT03962738|147571376|SUPERIORITY||Odds Ratio (OR)|1.77||||0.036|TWO_SIDED|95.0|1.04|3.03|||Regression, Logistic|||||3.03|1.04|0.036
74010099|NCT03962738|147571376|SUPERIORITY||Odds Ratio (OR)|1.93||||0.018|TWO_SIDED|95.0|1.12|3.33|||Regression, Logistic|||||3.33|1.12|0.018
74010100|NCT03962738|147571377|SUPERIORITY||Odds Ratio (OR)|1.67||||0.199|TWO_SIDED|95.0|0.76|3.65|||Regression, Logistic|||||3.65|0.76|0.199
74010101|NCT03962738|147571377|SUPERIORITY||Odds Ratio (OR)|1.33||||0.305|TWO_SIDED|95.0|0.77|2.32|||Regression, Logistic|||||2.32|0.77|0.305
74010102|NCT03962738|147571377|SUPERIORITY||Odds Ratio (OR)|1.26||||0.426|TWO_SIDED|95.0|0.71|2.24|||Regression, Logistic|||||2.24|0.71|0.426
74010103|NCT03962738|147571378|SUPERIORITY||Odds Ratio (OR)|1.57||||0.135|TWO_SIDED|95.0|0.87|2.82|||Regression, Logistic|||||2.82|0.87|0.135
74010104|NCT03962738|147571378|SUPERIORITY||Odds Ratio (OR)|1.48||||0.08|TWO_SIDED|95.0|0.95|2.3|||Regression, Logistic|||||2.30|0.95|0.080
74010105|NCT03962738|147571378|SUPERIORITY||Odds Ratio (OR)|1.56||||0.061|TWO_SIDED|95.0|0.98|2.49|||Regression, Logistic|||||2.49|0.98|0.061
74010106|NCT03962738|147571379|SUPERIORITY||Odds Ratio (OR)|1.38||||0.342|TWO_SIDED|95.0|0.71|2.67|||Regression, Logistic|||||2.67|0.71|0.342
74010107|NCT03962738|147571379|SUPERIORITY||Odds Ratio (OR)|1.25||||0.377|TWO_SIDED|95.0|0.76|2.04|||Regression, Logistic|||||2.04|0.76|0.377
74010108|NCT03962738|147571379|SUPERIORITY||Odds Ratio (OR)|1.05||||0.862|TWO_SIDED|95.0|0.63|1.72|||Regression, Logistic|||||1.72|0.63|0.862
74010109|NCT03962738|147571381|SUPERIORITY||Odds Ratio (OR)|3.43||||0.112|TWO_SIDED|95.0|0.75|15.65|||Regression, Logistic|||||15.65|0.75|0.112
74010110|NCT03962738|147571381|SUPERIORITY||Odds Ratio (OR)|9.05|||<|0.001|TWO_SIDED|95.0|2.68|30.55|||Regression, Logistic|||||30.55|2.68|<0.001
74040678|NCT01861054|147633371|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - IL-8||||0.2952
74040679|NCT01861054|147633371|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - IL-8||||0.3992
74040680|NCT01861054|147633371|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - IL-8||||0.2952
74040681|NCT01861054|147633371|OTHER|||||||0.525||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - IL-8||||0.5250
74040682|NCT01861054|147633371|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - US||||0.3992
74040683|NCT01861054|147633371|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - US||||0.2952
74040684|NCT01861054|147633371|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - US||||>0.9999
74092622|NCT02504671|147737906|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74092623|NCT02504671|147737906|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74092624|NCT02504671|147737906|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
73879224|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.78||0.0014|TWO_SIDED|95.0|-4.06|-0.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.98|-4.06|0.0014
74092625|NCT02504671|147737906|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74092626|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092627|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74040685|NCT01861054|147633371|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - US||||0.3992
74040686|NCT01861054|147633371|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - US||||0.3992
74040687|NCT01861054|147633371|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - US||||0.2952
74040688|NCT01861054|147633371|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - US||||0.3992
74040689|NCT01861054|147633371|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - US||||0.2952
74040690|NCT01861054|147633371|OTHER|||||||0.2238||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - LPS||||0.2238
74040691|NCT01861054|147633371|OTHER|||||||0.2238||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - LPS||||0.2238
74040692|NCT01861054|147633371|OTHER|||||||0.1543||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - LPS||||0.1543
74040693|NCT01861054|147633371|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - LPS||||0.1547
74040694|NCT01861054|147633371|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - LPS||||0.1547
74040695|NCT01861054|147633371|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - LPS||||0.1547
74040696|NCT01861054|147633371|OTHER|||||||0.4314||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - LPS||||0.4314
74040697|NCT01861054|147633371|OTHER|||||||0.3153||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - LPS||||0.3153
74092628|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-2.5|
74092629|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|68.2|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|-1.9|
73879225|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.49|-1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.37|-4.49|0.0003
73879226|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.01|TWO_SIDED|95.0|-3.61|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.49|-3.61|0.0100
73879227|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.78||0.0019|TWO_SIDED|95.0|-3.98|-0.91||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.91|-3.98|0.0019
73879228|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.78||0.0049|TWO_SIDED|95.0|-3.73|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.67|-3.73|0.0049
73879229|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.0186|TWO_SIDED|95.0|-3.25|-0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.30|-3.25|0.0186
73879230|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.75||0.0024|TWO_SIDED|95.0|-3.77|-0.82||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.82|-3.77|0.0024
73879231|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.76||0.0003|TWO_SIDED|95.0|-4.28|-1.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.30|-4.28|0.0003
73879232|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.77||0.0003|TWO_SIDED|95.0|-4.3|-1.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.29|-4.30|0.0003
73879233|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.76||0.0058|TWO_SIDED|95.0|-3.63|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.62|-3.63|0.0058
73879234|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.75||0.0008|TWO_SIDED|95.0|-4.04|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.7|-4.04|0.0008
74092630|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092631|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092632|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
73879235|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.005|TWO_SIDED|95.0|-3.59|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.64|-3.59|0.0050
73879236|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0205|TWO_SIDED|95.0|-3.63|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.31|-3.63|0.0205
73879237|NCT03192176|147297610|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.85||0.2818|TWO_SIDED|95.0|-2.58|0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.75|-2.58|0.2818
73879238|NCT03192176|147297610|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.87||0.3102|TWO_SIDED|95.0|-2.6|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.83|-2.60|0.3102
73879239|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.87||0.1422|TWO_SIDED|95.0|-2.99|0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.43|-2.99|0.1422
74010111|NCT03962738|147571381|SUPERIORITY||Odds Ratio (OR)|10.19|||<|0.001|TWO_SIDED|95.0|3.01|34.55|||Regression, Logistic|||||34.55|3.01|<0.001
74040698|NCT01861054|147633371|OTHER|||||||0.47||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - LPS+IL-8||||0.4700
74040699|NCT01861054|147633371|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - LPS+IL-8||||0.1605
74040700|NCT01861054|147633371|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - LPS+IL-8||||0.1605
74040701|NCT01861054|147633371|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - LPS+IL-8||||0.1605
74040702|NCT01861054|147633371|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - LPS+IL-8||||0.1547
74040703|NCT01861054|147633371|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - LPS+IL-8||||0.1547
74040704|NCT01861054|147633371|OTHER|||||||0.3153||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - LPS+IL-8||||0.3153
74040705|NCT01861054|147633371|OTHER|||||||0.1543||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - LPS+IL-8||||0.1543
74040706|NCT01861054|147633371|OTHER|||||||0.1601||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent FITC eColi Control||||0.1601
74040707|NCT01861054|147633371|OTHER|||||||0.2368||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent FITC eColi Test||||0.2368
74040708|NCT01861054|147633371|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent PMNs unstimulated||||0.1605
74040709|NCT01861054|147633371|OTHER|||||||0.47||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent PMNs fMLP||||0.4700
74040710|NCT01861054|147633371|OTHER|||||||0.3392||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent L-selectin unstimulated||||0.3392
74040711|NCT01861054|147633371|OTHER|||||||0.808||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent L-selectin fMLP||||0.8080
74040712|NCT00599027|147633375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Endpoint after 28 days of treatment|ANCOVA|Overall treatment effect tested using F-test(alpha=0.05;two-sided). Diff between least square means of the 2 groups calculated with two-sided 95% C.I||||||0.001
74040713|NCT00405821|147633376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED|95.0|0.58|0.99||P-value was adjusted to include multiple looks at data including an interim efficacy review at 50% and 75% accrual of person-years on study|Regression, Cox|adjusted for baseline log10 viral load, baseline CD4 count, gender, and age||Intent-to-treat analysis used Cox proportional hazards (CPH) models, adjusting for baseline log10 viral load (VL), CD4 cell count, gender and age to assess the risk of disease progression||0.99|0.58|<0.05
74040714|NCT00405821|147633377|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31|||<|0.05|TWO_SIDED|95.0|0.19|0.48||we included multiple GUD events per subject in the estimate of GUD incidence|rate ratio with 95% CI|||Null hypothesis is no difference by treatment arm in rate of GUD.||0.48|0.19|<0.05
74040715|NCT00405821|147633378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.463||||0.05|TWO_SIDED|95.0|-0.731|-0.194|||t-test, 2 sided|||Null hypothesis is no difference in annual rate of change in log10 viral load by arm.||-0.194|-0.731|0.05
74040716|NCT01181778|147633417|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Daily Pill|-0.4||||0.705|TWO_SIDED|95.0|-2.6|1.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Daily Pill before physician counseling and after physician counseling.||1.8|-2.6|0.705
74092633|NCT02504671|147737906|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092634|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092635|NCT02504671|147737906|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092636|NCT02504671|147737906|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092637|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092638|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092639|NCT02504671|147737906|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092640|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74040717|NCT01181778|147633417|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Weekly Patch|3.8|||<|0.0001|TWO_SIDED|95.0|2.6|5.0|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Weekly Patch before physician counseling and after physician counseling.||5.0|2.6|<0.0001
74092641|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092642|NCT02504671|147737906|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74040718|NCT01181778|147633417|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Monthy Ring|16.0|||<|0.0001|TWO_SIDED|95.0|14.3|17.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Monthly Ring before physician counseling and after physician counseling.||17.8|14.3|<0.0001
74040719|NCT01181778|147633417|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Other Method|-3.6|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.2|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Other Method before physician counseling and after physician counseling.||-2.2|-5.0|<0.0001
74040720|NCT01181778|147633417|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Undecided|-15.8|||<|0.0001|TWO_SIDED|95.0|-17.6|-14.1|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Undecided before physician counseling and after physician counseling.||-14.1|-17.6|<0.0001
74040721|NCT03788967|147633425|NON_INFERIORITY|The non-inferiority hypothesis test was a 1-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in overall response was greater than -12.5%, non-inferiority was declared.|Risk Difference|-3.3|||||TWO_SIDED|95.0|-9.7|3.2||||||||3.2|-9.7|
74040722|NCT03788967|147633427|OTHER||Risk Difference|-4.7|||||TWO_SIDED|95.0|-11.3|1.9||||||||1.9|-11.3|
74040723|NCT03788967|147633428|OTHER||Risk Difference|1.4|||||TWO_SIDED|95.0|-0.1|3.4||||||Statistical Analysis 1 (EOT)||3.4|-0.1|
74040724|NCT03788967|147633428|OTHER||Risk Difference|-0.6|||||TWO_SIDED|95.0|-4.0|2.8||||||Statistical Analysis 2 (TOC)||2.8|-4|
74092643|NCT02504671|147737906|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092644|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092645|NCT02504671|147737906|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74010112|NCT03962738|147571382|SUPERIORITY||Odds Ratio (OR)|0.78||||0.343|TWO_SIDED|95.0|0.46|1.31|||Regression, Logistic|||||1.31|0.46|0.343
74010113|NCT03962738|147571382|SUPERIORITY||Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.37|2.98|||Regression, Logistic|||||2.98|1.37|<0.001
74010114|NCT03962738|147571382|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.42|3.2|||Regression, Logistic|||||3.20|1.42|<0.001
74010115|NCT03962738|147571383|SUPERIORITY||Odds Ratio (OR)|1.19||||0.605|TWO_SIDED|95.0|0.62|2.26|||Regression, Logistic|||||2.26|0.62|0.605
74010116|NCT03962738|147571383|SUPERIORITY||Odds Ratio (OR)|1.8||||0.015|TWO_SIDED|95.0|1.12|2.9|||Regression, Logistic|||||2.90|1.12|0.015
74010117|NCT03962738|147571383|SUPERIORITY||Odds Ratio (OR)|1.23||||0.432|TWO_SIDED|95.0|0.74|2.05|||Regression, Logistic|||||2.05|0.74|0.432
74010118|NCT03962738|147571384|SUPERIORITY||Odds Ratio (OR)|1.77||||0.166|TWO_SIDED|95.0|0.79|3.96|||Regression, Logistic|||||3.96|0.79|0.166
74010119|NCT03962738|147571384|SUPERIORITY||Odds Ratio (OR)|1.34||||0.396|TWO_SIDED|95.0|0.68|2.62|||Regression, Logistic|||||2.62|0.68|0.396
74010120|NCT03962738|147571384|SUPERIORITY||Odds Ratio (OR)|1.58||||0.181|TWO_SIDED|95.0|0.81|3.11|||Regression, Logistic|||||3.11|0.81|0.181
74010121|NCT03962738|147571385|SUPERIORITY||Odds Ratio (OR)|1.44||||0.233|TWO_SIDED|95.0|0.79|2.64|||Regression, Logistic|||||2.64|0.79|0.233
74010122|NCT03962738|147571385|SUPERIORITY||Odds Ratio (OR)|1.5||||0.092|TWO_SIDED|95.0|0.94|2.41|||Regression, Logistic|||||2.41|0.94|0.092
74010123|NCT03962738|147571385|SUPERIORITY||Odds Ratio (OR)|1.8||||0.017|TWO_SIDED|95.0|1.11|2.92|||Regression, Logistic|||||2.92|1.11|0.017
74010124|NCT03962738|147571386|SUPERIORITY|||||||0.724|||||||ANCOVA|||||||0.724
74010125|NCT03962738|147571386|SUPERIORITY|||||||0.24|||||||ANCOVA|||||||0.240
74010126|NCT03962738|147571386|SUPERIORITY|||||||0.548|||||||ANCOVA|||||||0.548
74010127|NCT03962738|147571387|SUPERIORITY|||||||0.719|||||||ANCOVA|||||||0.719
74010128|NCT03962738|147571387|SUPERIORITY|||||||0.823|||||||ANCOVA|||||||0.823
74010129|NCT03962738|147571387|SUPERIORITY|||||||0.612|||||||ANCOVA|||||||0.612
74010130|NCT03962738|147571388|SUPERIORITY||Odds Ratio (OR)|1.78||||0.037|TWO_SIDED|95.0|1.04|3.07|||Regression, Logistic|||||3.07|1.04|0.037
74010131|NCT03962738|147571388|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.001|TWO_SIDED|95.0|1.75|4.06|||Regression, Logistic|||||4.06|1.75|<.001
74010132|NCT03962738|147571388|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|2.11|5.06|||Regression, Logistic|||||5.06|2.11|<.001
74010133|NCT03962738|147571389|SUPERIORITY|||||||0.162|||||||ANOVA|||Work Functioning||||0.162
74010134|NCT03962738|147571389|SUPERIORITY|||||||0.356|||||||ANOVA|||Social Functioning||||0.356
74010135|NCT03962738|147571389|SUPERIORITY|||||||0.696|||||||ANOVA|||Energy and Vitality||||0.696
74010136|NCT03962738|147571389|SUPERIORITY|||||||0.914|||||||ANOVA|||Feelings and Concerns||||0.914
74010137|NCT03962738|147571389|SUPERIORITY|||||||0.226|||||||ANOVA|||Migraine Symptoms||||0.226
74010138|NCT03962738|147571389|SUPERIORITY|||||||0.31|||||||ANOVA|||Work Functioning||||0.310
74010139|NCT03962738|147571389|SUPERIORITY|||||||0.684|||||||ANOVA|||Social Functioning||||0.684
74010140|NCT03962738|147571389|SUPERIORITY|||||||0.864|||||||ANOVA|||Energy and Vitality||||0.864
74010141|NCT03962738|147571389|SUPERIORITY|||||||0.412|||||||ANOVA|||Feelings and Concerns||||0.412
74010142|NCT03962738|147571389|SUPERIORITY|||||||0.025|||||||ANOVA|||Migraine Symptoms||||0.025
74010143|NCT03962738|147571389|SUPERIORITY|||||||0.619|||||||ANOVA|||Work Functioning||||0.619
74010144|NCT03962738|147571389|SUPERIORITY|||||||0.824|||||||ANOVA|||Social Functioning||||0.824
74010145|NCT03962738|147571389|SUPERIORITY|||||||0.476|||||||ANOVA|||Energy and Vitality||||0.476
74010146|NCT03962738|147571389|SUPERIORITY|||||||0.352|||||||ANOVA|||Feelings and Concerns||||0.352
74040725|NCT03788967|147633428|OTHER||Risk Difference|-1.5|||||TWO_SIDED|95.0|-5.7|2.6||||||Statistical Analysis 3 (LFU)||2.6|-5.7|
74040726|NCT03788967|147633429|OTHER||Risk Difference|0.7|||||TWO_SIDED|95.0|-0.3|2.0||||||||2.0|-0.3|
74040727|NCT03788967|147633430|OTHER||Risk Difference|-1.6|||||TWO_SIDED|95.0|-3.8|0.6||||||||0.6|-3.8|
74040728|NCT03788967|147633431|OTHER||Risk Difference|-0.5|||||TWO_SIDED|95.0|-3.3|2.3||||||||2.3|-3.3|
74040729|NCT03788967|147633432|OTHER||Risk Difference|1.3|||||TWO_SIDED|95.0|-0.2|3.2||||||||3.2|-0.2|
74040730|NCT03788967|147633433|OTHER||Risk Difference|-2.2|||||TWO_SIDED|95.0|-5.3|0.8||||||||0.8|-5.3|
74040731|NCT03788967|147633434|OTHER||Risk Difference|-1.2|||||TWO_SIDED|95.0|-5.1|2.6||||||||2.6|-5.1|
74040732|NCT03788967|147633435|OTHER||Risk Difference|1.5|||||TWO_SIDED|95.0|-0.8|4.1||||||Statistical Analysis 1 (EOT)||4.1|-0.8|
74040733|NCT03788967|147633435|OTHER||Risk Difference|-4.5|||||TWO_SIDED|95.0|-10.8|1.9||||||Statistical Analysis 2 (TOC)||1.9|-10.8|
74040734|NCT03788967|147633435|OTHER||Risk Difference|-1.5|||||TWO_SIDED|95.0|-7.9|5.0||||||||5|-7.9|
74040735|NCT03788967|147633439|OTHER||Risk Difference|-0.2|||||TWO_SIDED|95.0|-1.6|1.2||||||||1.2|-1.6|
74040736|NCT03788967|147633440|OTHER||Risk Difference|-5.9|||||TWO_SIDED|95.0|-12.4|0.7||||||||0.7|-12.4|
74040737|NCT03788967|147633441|OTHER||Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-8.5|5.3||||||||5.3|-8.5|
74040738|NCT03788967|147633445|OTHER||Risk Difference|-4.7|||||TWO_SIDED|95.0|-13.5|4.1||||||Overall response for participants with AP||4.1|-13.5|
74040739|NCT03788967|147633445|OTHER||Risk Difference|-1.6|||||TWO_SIDED|95.0|-11.0|7.7||||||Overall response in participants with cUTI||7.7|-11.0|
74040740|NCT03788967|147633446|OTHER||Risk Difference|1.4|||||TWO_SIDED|95.0|-7.2|9.9||||||||9.9|-7.2|
74040741|NCT03788967|147633446|OTHER||Risk Difference (RD)|-8.4|||||TWO_SIDED|95.0|-20.6|3.8||||||≥65 to \<75 years||3.8|-20.6|
74040742|NCT03788967|147633446|OTHER||Risk Difference (RD)|-7.5|||||TWO_SIDED|95.0|-23.8|8.7||||||≥75 years||8.7|-23.8|
74040743|NCT03788967|147633447|OTHER||Risk Difference|-3.1|||||TWO_SIDED|95.0|-9.6|3.5||||||Central and Eastern Europe||3.5|-9.6|
74040744|NCT03788967|147633448|OTHER|||||||0.044|||||||Log Rank|||||||0.044
74040745|NCT03788967|147633449|OTHER|||||||0.736|||||||Log Rank|||||||0.736
74040746|NCT02455388|147633460|EQUIVALENCE|No equivalence margin set.|||||<|0.001|||||||Intraclass correlation coefficient|||||||<0.001
74040747|NCT02455388|147633461|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74040748|NCT02455388|147633462|OTHER||Odds Ratio (OR)|1.7|||<|0.01|TWO_SIDED||||||Regression, Logistic|||||||<0.01
74040749|NCT01016678|147633473|SUPERIORITY_OR_OTHER||Difference in percentages|18.0||||0.0038|TWO_SIDED||||||Chi-squared|||Comparison of percentage of participants pain free at 2 hours post-dose (active) to percentage of participants pain free at 2 hours post-dose (placebo)||||0.0038
74040750|NCT01016678|147633474|SUPERIORITY_OR_OTHER||difference in percentages|8.0||||0.1294|TWO_SIDED||||||Chi-squared|||||||0.1294
74040751|NCT00962754|147633477|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority since our hypothesis was that there would be no difference in outcome between the intervention and the control group.|Adjusted ratio of geometric means|1.0|||<|0.05|TWO_SIDED|95.0|0.81|1.19||"log transformation of mean duration of hospitalization,difference between two groups expressed as ratio of geometric means for duration. 95% confidence intervals calculated using bootstrapping method.~correction by linear regression model"|t-test, 2 sided|||We calculated that 85 patients in each group would give a power in excess of 85% to detect a difference of two days or more in the geometric mean length of hospital stay with a two-sided significance level of 0.05.||1.19|0.81|<0.05
74040752|NCT00093470|147633480|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.026|TWO_SIDED|95.0|0.538|1.072||one-sided p-value; threshold for statistical significance \<0.025|Log Rank|stratified log rank test|Hazard ratio of DFS for Arm A to Arm B|||1.072|0.538|0.026
74040753|NCT00093470|147633481|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.809||||0.056|TWO_SIDED|95.0|0.567|1.155||one-sided p-value; threshold for statistical significance \< 0.025|Log Rank|stratified log rank test|Hazard ratio of OS for Arm A to Arm B|||1.155|0.567|0.056
74040754|NCT02514772|147633482|OTHER||Difference (%)|-1.9|||||TWO_SIDED|95.0|-20.6|16.9||||||||16.9|-20.6|
74040755|NCT02514772|147633483|OTHER||Difference (%)|-1.7|||||TWO_SIDED|95.0|-20.6|16.9||||||||16.9|-20.6|
74040756|NCT02514772|147633484|OTHER||Difference (%)|-1.9|||||TWO_SIDED|95.0|-21.2|17.6||||||||17.6|-21.2|
74040757|NCT02514772|147633485|OTHER||Mean Difference (Final Values)|-5.4|||||TWO_SIDED|95.0|-24.2|13.3||||||Incidence difference of infusion-related reactions, occurred on day of or on day after first infusion (i.e. on study day 1 or on study day 2).||13.3|-24.2|
74040758|NCT02514772|147633485|OTHER||Mean Difference (Final Values)|-5.3|||||TWO_SIDED|95.0|-24.5|13.6||||||Incidence difference of infusion-related reactions, occurred on day of or on day after second infusion (i.e. on study day 14 or on study day 15).||13.6|-24.5|
74040759|NCT02514772|147633485|OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-26.0|11.4||||||Incidence difference of infusion-related reactions overall on day(s) of or day(s) after either infusion (i.e. on day 1 or 2 and on day 14 or day 15).||11.4|-26.0|
74040760|NCT01226706|147633532|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||"A sample of 16 subjects per group was required to detect a mean difference of 50 mL in maximum capacity at cystoscopy between botulinum toxin and placebo at 90% power with a two-sided type I error of 5%.~Difference scores were computed for the primary outcome, which were then compared using the Wilcoxon- Mann-Whitney U test. This type of analysis was used to identify both between group differences and within group differences (over time) while using non-parametric statistics."||||.016
74040761|NCT01226706|147633533|SUPERIORITY_OR_OTHER|||||||0.152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.152
74040762|NCT01226706|147633534|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.095
74040763|NCT01226706|147633535|SUPERIORITY_OR_OTHER|||||||0.067|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.067
74010147|NCT03962738|147571389|SUPERIORITY|||||||0.044|||||||ANOVA|||Migraine Symptoms||||0.044
74010148|NCT00509067|147571391|SUPERIORITY|||||||0.93||||||alpha set at P \< .05|Mixed Models Analysis|Time (0, 4, 8, 12, 16 wks) x Treatment (Drug, Placebo) Effect: F(1, 33)=0.01.||||||0.93
74010149|NCT00509067|147571392|SUPERIORITY|||||||0.23||||||alpha level set at .05|Mixed Models Analysis|Time (0, 8, 16 weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48..||||||0.23
74010150|NCT00509067|147571392|SUPERIORITY|||||||0.23||||||alpha set at P\<0.05|Mixed Models Analysis|Time (0, 8, 16, weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48.||||||0.23
74040764|NCT01226706|147633539|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.038
74040765|NCT01226706|147633540|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.095
74040766|NCT01226706|147633541|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.038
74040767|NCT01226706|147633545|SUPERIORITY_OR_OTHER|||||||0.904|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.904
74040768|NCT01226706|147633546|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.080
74040769|NCT01226706|147633547|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.230
74040770|NCT01226706|147633551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.021|TWO_SIDED|95.0|-2.1|-0.2|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.2|-2.1|0.021
74040771|NCT01226706|147633552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.007|TWO_SIDED|95.0|-2.1|-0.5|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.5|-2.1|0.007
74040772|NCT01226706|147633553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.013|TWO_SIDED|95.0|-2.0|-0.4|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.4|-2.0|0.013
74040773|NCT01226706|147633554|SUPERIORITY_OR_OTHER|||||||0.173|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.173
74040774|NCT01226706|147633555|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.051
74040775|NCT01226706|147633556|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.051
74040776|NCT01226706|147633557|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.557
74040777|NCT01226706|147633558|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.029
74040778|NCT01226706|147633559|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.132
74040779|NCT01226706|147633560|SUPERIORITY_OR_OTHER|||||||0.085|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.085
74040780|NCT01226706|147633561|SUPERIORITY_OR_OTHER|||||||0.099|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.099
74040781|NCT01226706|147633562|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.132
74040782|NCT01226706|147633563|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.072
74010151|NCT03654976|147571458|SUPERIORITY||Rate ratio|0.89||||0.5412|TWO_SIDED|95.0|0.6|1.31|||Negative binomial regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The number of clinically relevant asthma exacerbations was analyzed using a negative binomial regression model with a log-link function and the logarithm of the time in years in the efficacy period as offset. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||1.31|0.60|0.5412
74040783|NCT01226706|147633564|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.230
74040784|NCT01226706|147633565|SUPERIORITY_OR_OTHER|||||||0.314|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.314
74040785|NCT01226706|147633566|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.013
74040786|NCT01226706|147633567|SUPERIORITY_OR_OTHER|||||||0.888|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.888
74040787|NCT03037307|147633614|OTHER||Least square (LS) mean difference|2.76|||<|0.0001|TWO_SIDED|95.0|1.89|3.63||Treatment Comparison for study validity.|ANCOVA|ANCOVA: factors for participant (random effect); period \& treatment, participant-level \& period-level pre-treatment baseline bite force as covariates.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||3.63|1.89|<.0001
74010152|NCT03654976|147571459|SUPERIORITY||Odds Ratio (OR)|0.7713||||0.4156|TWO_SIDED|95.0|0.41|1.44|||Marginal logistic regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|A marginal logistic regression model with a generalized estimating approach was analyzed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.||1.44|0.41|0.4156
74092646|NCT02504671|147737906|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092647|NCT02504671|147737906|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74010153|NCT03654976|147571460|SUPERIORITY||Odds Ratio (OR)|0.8477||||0.4146|TWO_SIDED|95.0|0.57|1.26|||Marginal logistic regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|A marginal logistic regression model with a generalized estimating approach was analyzed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit is included as a covariate. No missing data approach was applied.||1.26|0.57|0.4146
74010154|NCT03654976|147571461|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.8829|TWO_SIDED|95.0|-1.47|1.7|||Mixed-effect model repeated measurement||12 SQ-HDM - placebo|A 'mixed-effect model repeated measurement' model was analysed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.||1.70|-1.47|0.8829
74010155|NCT03654976|147571462|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0044|TWO_SIDED|95.0|1.29|3.96|||Generalised linear mixed model||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The odds of having an improved outcome was analyzed using a generalized linear mixed model (GLMM) with a logit link function. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||3.96|1.29|0.0044
74010156|NCT03654976|147571463|SUPERIORITY||Odds Ratio, log|1.62||||0.0698|TWO_SIDED|95.0|0.96|2.74|||Generalised linear mixed model||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The odds of having an improved outcome was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||2.74|0.96|0.0698
74010157|NCT04261504|147571489|SUPERIORITY|||||||0.03||||||Threshold p\<0.05.|threshold-free cluster enhancement|||||||0.03
74010158|NCT02504554|147571497|OTHER||||||<|0.001||||||"no adjustment for multiple hypothesis testing since this was an exploratory study.~the p-value listed is the actual result from analysis of the study data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank analysis of symptoms at 10 weeks (end of treatment) vs. baseline||||<0.001
74010159|NCT02504554|147571498|OTHER|paired 2-sided t-test comparing baseline and 10 weeks (end of treatment)|||||<|0.001||||||no adjustment for multiple comparisons|t-test, 2 sided|paired t-test, 2 sided||||||<0.001
74010160|NCT02504554|147571500|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~The p-value listed is the result for the actual analysis of the data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing the baseline score vs. the score at 10 weeks (end of treatment).||||<0.001
74010161|NCT02504554|147571501|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the study results."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing scores at baseline vs. 10 weeks (end of treatment)||||<0.001
74010162|NCT02504554|147571503|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the analysis of the study data"|t-test, 2 sided|||2-sided t-test comparing the group at baseline vs. 18 weeks (8 weeks after end of treatment)||||<0.001
74010163|NCT02504554|147571504|OTHER|||||||0.002||||||no adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare scores at baseline vs. at 10 weeks (end of treatment)||||0.002
74010164|NCT01020591|147571510|NON_INFERIORITY_OR_EQUIVALENCE|The power and sample size calculations, based on the ability to detect treatment and evaluation group differences, were performed on Minitab™ V.15. 40 participants were estimated to be required for group allocation (20 in each group: evaluation;evaluation and treatment)for 80% power in at least 3 out of the 4 outcome measures. After 30 subjects, analysis determined that there would be no further statistically significant changes in results therefore, data collection was stopped at 30 subjects.|||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||A two factor mixed model Analysis of Variance (ANOVA) for Group (Evaluation vs. Treatment) with repeated measures (pre vs. post test) was employed to test for main effects and all interactions for the Resistive Index||||<0.05
74010165|NCT00427349|147571516|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||one sample binomial test|The study result was compared to a null hypothesis of 20% 4-month progression free survival rate using one sample binomial test||The null hypothesis is that the 4-month progression free survival rate is 20%. Alternatively, AMG 706 will be considered worthy of further study if its true progression-free survival rate is 40% or better at 4 months (alternative hypothesis).||||<0.001
74010166|NCT00698997|147571528|OTHER|Non- equivalence.|slope difference|1.01||||0.03|TWO_SIDED||||||Mixed Models Analysis|||We used a generalized linear mixed model (GLMM). Change-over-Time was modeled as a linear within-subject effect of time across all observed data for each participant. We fit splines to manage the differing lengths of time in parent-training versus direct treatment. In all analyses, site was included as a categorical covariate to account for potential differences. Effect sizes were reported following Cohen's recommendations as f2.||||.03
74010167|NCT05082376|147571551|OTHER||Adjusted Mean Difference|7.7|||<|0.0001|TWO_SIDED|95.0|6.6|8.8|||ANCOVA|Analysis of Covariance (ANCOVA) model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 2 hours post-treatment||8.8|6.6|<0.0001
74040788|NCT03037307|147633615|OTHER||Least Square (LS) mean difference|2.12|||<|0.0001|TWO_SIDED|95.0|1.25|3.0|||ANCOVA|ANCOVA: factors for participant (random effect); period \& treatment, participant-level \& period-level pre-treatment baseline bite force as covariates|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||3.00|1.25|<.0001
74040789|NCT01700985|147633654|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74040790|NCT01700985|147633655|SUPERIORITY||||||<|0.0001||||||At Day 15.|Fisher Exact|||||||<0.0001
74040791|NCT01700985|147633656|SUPERIORITY||||||<|0.0001||||||At Day 15.|Fisher Exact|||||||<0.0001
74040792|NCT00067470|147633665|SUPERIORITY_OR_OTHER||Mean Difference (Net)|92.0|STANDARD_ERROR_OF_MEAN|40.0||0.025||95.0|11.0|172.0|||Regression, Linear|||||172|11|0.025
74040793|NCT00067470|147633666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.7|STANDARD_ERROR_OF_MEAN|2.9||0.053||95.0|-0.1|11.5|||Regression, Linear|The raw data were adjusted for the observed differences in baseline between the groups and fitted to a longitudinal repeated measures linear model.||||11.5|-0.1|0.053
74040794|NCT03859960|147633678|OTHER|||||||0.006|||||||Pearson correlation test|||||||0.006
73879240|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.87||0.0064|TWO_SIDED|95.0|-4.12|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.68|-4.12|0.0064
74040795|NCT03859960|147633678|OTHER|||||||0.23||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.23
74040796|NCT03859960|147633679|OTHER|||||||0.001||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.001
74040797|NCT03859960|147633679|OTHER|||||||0.731|||||||Pearson correlation test|||||||0.731
74040798|NCT03859960|147633680|OTHER|||||||0.214|||||||Pearson correlation test|||||||0.214
74040799|NCT03859960|147633680|OTHER|||||||0.993||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.993
74040800|NCT03859960|147633681|OTHER|||||||0.41|||||||Pearson correlation test|||||||0.41
74040801|NCT03859960|147633681|OTHER|||||||0.676|||||||Pearson correlation test|||||||0.676
74040802|NCT03859960|147633682|OTHER|||||||0.511||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.511
74040803|NCT03859960|147633682|OTHER|||||||0.248|||||||Pearson correlation test|||||||0.248
74040804|NCT03859960|147633683|OTHER|||||||0.654|||||||Pearson correlation test|||||||0.654
74040805|NCT03859960|147633683|OTHER|||||||0.025|||||||Pearson correlation test|||||||0.025
74040806|NCT02703987|147633687|SUPERIORITY||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0801|TWO_SIDED|95.0|-0.04|0.67|||Mixed Models Analysis|||||0.67|-0.04|0.0801
74040807|NCT02703987|147633688|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.18||0.0714|TWO_SIDED|95.0|-0.03|0.71|||Mixed Models Analysis|||||0.71|-0.03|0.0714
74040808|NCT02703987|147633689|SUPERIORITY||Mean Difference (Net)|9.56|STANDARD_ERROR_OF_MEAN|4.85||0.0609|TWO_SIDED|95.0|-0.48|19.6|||Mixed Models Analysis|||||19.6|-0.48|0.0609
74040809|NCT03970824|147633697|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|105.79|||||TWO_SIDED|90.0|97.19|115.16||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||115.16|97.19|
74040810|NCT03970824|147633697|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|92.63|||||TWO_SIDED|90.0|85.29|100.61||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||100.61|85.29|
74040811|NCT03970824|147633697|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|98.0|||||TWO_SIDED|90.0|90.06|106.63||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||106.63|90.06|
74040812|NCT03970824|147633698|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|107.3|||||TWO_SIDED|90.0|98.29|117.13||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||117.13|98.29|
74040813|NCT03970824|147633698|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|93.93|||||TWO_SIDED|90.0|86.08|102.5||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||102.50|86.08|
74040814|NCT03970824|147633698|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|100.79|||||TWO_SIDED|90.0|92.42|109.92||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||109.92|92.42|
74040815|NCT03970824|147633699|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|101.89|||||TWO_SIDED|90.0|95.33|108.89||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||108.89|95.33|
74040816|NCT03970824|147633699|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|98.2|||||TWO_SIDED|90.0|91.91|104.92||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||104.92|91.91|
74040817|NCT03970824|147633699|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|100.05|||||TWO_SIDED|90.0|93.69|106.85||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||106.85|93.69|
74040818|NCT00305604|147633712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.81|<|0.001||95.0|-0.94|-0.47|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-0.47|-0.94|<0.001
74040819|NCT00305604|147633713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.8|STANDARD_DEVIATION|45.0|<|0.001||95.0|-40.0|-13.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-13.5|-40.0|<0.001
74040820|NCT00305604|147633714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.0|STANDARD_DEVIATION|63.0|<|0.001||95.0|-82.1|-40.0|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-40.0|-82.1|<0.001
74040821|NCT00305604|147633715|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.5|STANDARD_DEVIATION|25.2|<|0.001||95.0|-32.6|-14.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-14.4|-32.6|<0.001
74040822|NCT01248364|147633716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.279|TWO_SIDED|95.0|-0.16|0.55|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group, and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.55|-0.16|0.2790
74040823|NCT01248364|147633717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2438|TWO_SIDED|95.0|-0.16|0.62|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.62|-0.16|0.2438
74040824|NCT01248364|147633718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6931|TWO_SIDED|95.0|-1.19|1.79|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||1.79|-1.19|0.6931
74040825|NCT01248364|147633719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|1.12||0.1028|TWO_SIDED|95.0|-0.38|4.07|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||4.07|-0.38|0.1028
74040826|NCT01248364|147633720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|2.52||0.0326|TWO_SIDED|95.0|0.47|10.5|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||10.50|0.47|0.0326
74040827|NCT01248364|147633721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.81||0.0552|TWO_SIDED|95.0|-3.2|0.04|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.04|-3.20|0.0552
74040828|NCT01248364|147633722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.99||0.7561|TWO_SIDED|95.0|-1.66|2.27|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||2.27|-1.66|0.7561
74040829|NCT01248364|147633723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.13|STANDARD_ERROR_OF_MEAN|1.89||0.1024|TWO_SIDED|95.0|-0.64|6.9|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||6.90|-0.64|0.1024
74040830|NCT01248364|147633724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|2.93||0.6576|TWO_SIDED|95.0|-4.53|7.14|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||7.14|-4.53|0.6576
74040831|NCT01248364|147633725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|3.38||0.2795|TWO_SIDED|95.0|-10.41|3.05|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||3.05|-10.41|0.2795
74040832|NCT01192204|147633739|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||Statistical analyses reflect percent change intrapatient pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|We used a 2-tailed Mann Whitney U test to evaluate these data.||Wilcoxon matched-pairs signed rank test (intrapatient pre versus post treatment scores)||||0.048
74040833|NCT01192204|147633739|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Statistical analyses reflect percent change pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|||Wilcoxon matched-pairs signed rank test (pre versus post treatment scores)||||0.50
74040834|NCT01192204|147633740|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||Wilcoxon matched-pairs signed rank test|specifically, we used the Wilcoxon matched-pairs signed rank test.||||||<0.002
74040835|NCT01192204|147633740|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Wilcoxon matched-pairs signed rank test|||||||0.036
74040836|NCT01192204|147633741|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||2-tailed unpaired t test|||||||0.002
74040837|NCT01192204|147633741|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||two-tailed unpaired t test|||||||0.16
74040838|NCT02146248|147633742|SUPERIORITY_OR_OTHER|||||||0.4795||||||The two-tailed P value equals 0.4795|McNemar|||McNemar paired. Hypothesis is no change in tubal patency status. All subjects know to have bilateral patency in one of the exams during natural cycle||||0.4795
74040839|NCT02431468|147633753|SUPERIORITY||Mean Difference (Net)|6.5|||<|0.1|TWO_SIDED|80.0||||LSM and two-sided 80% CI were provided for treatment group differences and estimated endpoint values. A true mean difference in change from baseline in the SIB (one-sided at α=0.10) of at least 6.5 points in favor of bryostatin groups was assumed.|t-test, 1 sided|||The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the Severe Impairment Battery (SIB) after 12 weeks of treatment. A linear model was used for both estimation and significance testing. Primary analysis populations were defined as the Full Analysis Set (FAS) and the Completer Analysis Set (CAS)||||<0.1
74040840|NCT02431468|147633753|SUPERIORITY||Mean Difference (Net)|6.5|||<|0.1|TWO_SIDED|80.0|||||t-test, 1 sided|||Change from baseline in SIB in the Completer Analysis Set (CAS)||||<0.1
74040841|NCT03589885|147633760|SUPERIORITY||Odds Ratio (OR)|1014.07|||<|0.0001|TWO_SIDED|95.0|68.83|14940.62|||Regression, Logistic|||PASI 75||14940.62|68.83|<0.0001
74040842|NCT03589885|147633760|SUPERIORITY||Odds Ratio (OR)|96.23|||<|0.0001|TWO_SIDED|95.0|17.22|537.78|||Regression, Logistic|||PASI 75||537.78|17.22|<0.0001
74040843|NCT03589885|147633761|SUPERIORITY||Odds Ratio (OR)|51.46|||<|0.0001|TWO_SIDED|95.0|11.95|221.64|||Regression, Logistic|||||221.64|11.95|<0.0001
74040844|NCT03589885|147633761|SUPERIORITY||Odds Ratio (OR)|29.7|||<|0.0001||95.0|7.38|119.57|||Regression, Logistic|||||119.57|7.38|<0.0001
74040845|NCT03589885|147633762|SUPERIORITY||Odds Ratio (OR)|88.46|||<|0.0001|TWO_SIDED|95.0|16.15|484.52|||Regression, Logistic|||||484.52|16.15|<0.0001
74040846|NCT03589885|147633762|SUPERIORITY||Odds Ratio (OR)|37.9|||<|0.0001|TWO_SIDED|95.0|7.6|189.01|||Regression, Logistic|||||189.01|7.60|<0.0001
74040847|NCT00039741|147633773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.26|TWO_SIDED|95.0|-0.41|0.11|||Interval regression|Adjusted for baseline HIV-1 RNA, age (\<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.||||0.11|-0.41|0.26
74040848|NCT00039741|147633773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.56|TWO_SIDED|95.0|-0.2|0.32|||Interval regression|Adjusted for baseline HIV-1 RNA, age (\<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.||||0.32|-0.20|0.56
74040849|NCT01948141|147633838|SUPERIORITY_OR_OTHER|||||||0.59|||||||Log Rank|||||||0.59
74040850|NCT01948141|147633841|SUPERIORITY_OR_OTHER|||||||0.36|||||||Log Rank|||||||0.36
74040851|NCT04962503|147633854|OTHER|||||||0.0313||||||Change from baseline to Day 3|Wilcoxon (Mann-Whitney)|||||||0.0313
74040852|NCT04962503|147633854|OTHER|||||||0.0625||||||Change from baseline to Day 9|Wilcoxon (Mann-Whitney)|||||||0.0625
74040853|NCT00476996|147633857|SUPERIORITY||Weighted Difference|20.4|||<|0.0001|TWO_SIDED|95.0|12.8|27.9|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||27.9|12.8|< 0.0001
74040854|NCT00476996|147633857|SUPERIORITY||Weighted Difference|25.2|||<|0.0001|TWO_SIDED|95.0|17.7|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||32.7|17.7|< 0.0001
74092648|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092649|NCT02504671|147737907|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092650|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092651|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092652|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092653|NCT02504671|147737907|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092654|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092655|NCT02504671|147737907|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092656|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092657|NCT02504671|147737907|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74040855|NCT00476996|147633857|SUPERIORITY||Weighted Difference|29.1|||<|0.0001|TWO_SIDED|95.0|21.6|36.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||36.6|21.6|< 0.0001
74040856|NCT00476996|147633857|SUPERIORITY||Weighted Difference|30.3|||<|0.0001|TWO_SIDED|95.0|22.8|37.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||37.7|22.8|< 0.0001
74040857|NCT00476996|147633858|SUPERIORITY||Weighted Difference|2.1||||0.1885|TWO_SIDED|95.0|-1.0|5.2|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy||5.2|-1.0|0.1885
74040858|NCT00476996|147633858|SUPERIORITY||Weighted Difference|3.6||||0.033|TWO_SIDED|95.0|0.3|6.8|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy||6.8|0.3|0.0330
74040859|NCT00476996|147633859|SUPERIORITY||Weighted Difference|4.2||||0.0175|TWO_SIDED|95.0|0.7|7.6|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||7.6|0.7|0.0175
74040860|NCT00476996|147633859|SUPERIORITY||Weighted Difference|4.3||||0.0134|TWO_SIDED|95.0|0.9|7.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||7.8|0.9|0.0134
74040861|NCT00476996|147633859|SUPERIORITY||Weighted Difference|10.5|||<|0.0001|TWO_SIDED|95.0|6.2|14.8|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||14.8|6.2|< 0.0001
74040862|NCT00476996|147633859|SUPERIORITY||Weighted Difference|10.5|||<|0.0001|TWO_SIDED|95.0|6.2|14.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||14.7|6.2|< 0.0001
74040863|NCT00476996|147633860|SUPERIORITY||Adjusted Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.3|-0.8|< 0.0001
74040864|NCT00476996|147633860|SUPERIORITY||Adjusted Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.6|-1.1|< 0.0001
74092658|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092659|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092660|NCT02504671|147737907|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74040865|NCT00476996|147633860|SUPERIORITY||Adjusted Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.7|-1.2|< 0.0001
74040866|NCT00476996|147633860|SUPERIORITY||Adjusted Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.9|-1.5|< 0.0001
74040867|NCT00476996|147633861|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.85|3.66|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy||3.66|1.85|< 0.0001
74040868|NCT00476996|147633861|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.0001|TWO_SIDED|95.0|2.49|4.91|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy||4.91|2.49|< 0.0001
74040869|NCT00476996|147633861|SUPERIORITY||Odds Ratio (OR)|4.18|||<|0.0001|TWO_SIDED|95.0|2.93|5.96|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy||5.96|2.93|< 0.0001
74040870|NCT00476996|147633861|SUPERIORITY||Odds Ratio (OR)|5.04|||<|0.0001|TWO_SIDED|95.0|3.54|7.18|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy||7.18|3.54|< 0.0001
74040871|NCT00476996|147633862|SUPERIORITY||Weighted Difference|13.2|||<|0.0001|TWO_SIDED|95.0|7.4|19.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||19.1|7.4|< 0.0001
74040872|NCT00476996|147633862|SUPERIORITY||Weighted Difference|16.2|||<|0.0001|TWO_SIDED|95.0|10.2|22.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||22.1|10.2|< 0.0001
74040873|NCT00476996|147633862|SUPERIORITY||Weighted Difference|19.3|||<|0.0001|TWO_SIDED|95.0|12.9|25.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||25.6|12.9|< 0.0001
74040874|NCT00476996|147633862|SUPERIORITY||Weighted Difference|20.8|||<|0.0001|TWO_SIDED|95.0|14.5|27.1|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||27.1|14.5|< 0.0001
74040875|NCT00476996|147633863|SUPERIORITY||Weighted Difference|4.6||||0.0203|TWO_SIDED|95.0|0.7|8.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||8.5|0.7|0.0203
74040876|NCT00476996|147633863|SUPERIORITY||Weighted Difference|6.7||||0.0014|TWO_SIDED|95.0|2.6|10.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||10.8|2.6|0.0014
74040877|NCT00476996|147633863|SUPERIORITY||Weighted Difference|6.6||||0.0042|TWO_SIDED|95.0|2.1|11.2|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||11.2|2.1|0.0042
74040878|NCT00476996|147633863|SUPERIORITY||Weighted Difference|13.4|||<|0.0001|TWO_SIDED|95.0|8.2|18.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||18.6|8.2|< 0.0001
74040879|NCT00476996|147633864|SUPERIORITY||Weighted Difference|19.4|||<|0.0001|TWO_SIDED|95.0|11.3|27.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||27.5|11.3|< 0.0001
74040880|NCT00476996|147633864|SUPERIORITY||Weighted Difference|24.7|||<|0.0001|TWO_SIDED|95.0|16.8|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||32.7|16.8|< 0.0001
74040881|NCT00476996|147633864|SUPERIORITY||Weighted Difference|27.2|||<|0.0001|TWO_SIDED|95.0|19.5|34.9|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||34.9|19.5|< 0.0001
74040882|NCT00476996|147633864|SUPERIORITY||Weighted Difference|27.6|||<|0.0001|TWO_SIDED|95.0|20.0|35.3|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||35.3|20.0|< 0.0001
74040883|NCT01769469|147633868|OTHER|||||||0.2085|||||||Wilcoxon (Mann-Whitney)|||Test of difference at Week 48 from baseline||||0.2085
74040884|NCT01769469|147633872|SUPERIORITY|||||||0.2452|||||||Wilcoxon Signed Rank Test|||||||0.2452
74040885|NCT01769469|147633880|SUPERIORITY|||||||0.0806|||||||Wilcoxon Signed Rank Test|||||||.0806
74040886|NCT01769469|147633891|OTHER|||||||0.6545|||||||Wilcoxon Signed Rank Test|||||||0.6545
74040887|NCT01769469|147633895|OTHER|||||||0.8739|||||||Wilcoxon Signed Rank Test|||||||0.8739
74040888|NCT01769469|147633903|OTHER|||||||0.5014|||||||Wilcoxon Signed Rank Test|||||||0.5014
74040889|NCT01769469|147633904|OTHER|||||||0.2431|||||||Wilcoxon Signed Rank Test|||||||0.2431
74040890|NCT01769469|147633905|OTHER|||||||0.7209|||||||Wilcoxon Signed Rank Test|||||||0.7209
74040891|NCT01769469|147633906|OTHER|||||||0.5379|||||||Wilcoxon Signed Rank Test|||||||0.5379
74040892|NCT01769469|147633907|OTHER|||||||0.7986|||||||Wilcoxon Signed Rank Test|||||||0.7986
74040893|NCT01769469|147633927|OTHER|||||||0.8507|||||||Wilcoxon Signed Rank Test|||||||0.8507
74040894|NCT01769469|147633928|OTHER|||||||0.3483|||||||Wilcoxon Signed Rank Test|||||||0.3483
74040895|NCT01769469|147633935|OTHER|||||||0.4043|||||||Wilcoxon (Mann-Whitney)|||||||0.4043
74040896|NCT01769469|147633936|OTHER|||||||0.2927|||||||Wilcoxon (Mann-Whitney)|||||||0.2927
74040897|NCT01769469|147633937|OTHER|||||||0.1134|||||||Wilcoxon (Mann-Whitney)|||||||0.1134
74040898|NCT01769469|147633938|OTHER|||||||0.5782|||||||Wilcoxon (Mann-Whitney)|||||||0.5782
74040899|NCT01769469|147633939|OTHER|||||||0.8658|||||||Wilcoxon (Mann-Whitney)|||||||0.8658
74040900|NCT01769469|147633940|OTHER|||||||0.5491|||||||Wilcoxon (Mann-Whitney)|||||||0.5491
74040901|NCT01769469|147633941|OTHER|||||||0.0238|||||||Wilcoxon (Mann-Whitney)|||||||0.0238
74040902|NCT01769469|147633942|OTHER|||||||0.1172|||||||Wilcoxon (Mann-Whitney)|||||||0.1172
74040903|NCT01769469|147633943|OTHER|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||0.1220
74040904|NCT01769469|147633944|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
74040905|NCT01769469|147633946|OTHER|||||||0.7785|||||||Wilcoxon (Mann-Whitney)|||||||0.7785
74040906|NCT01769469|147633947|OTHER|||||||0.4933|||||||Wilcoxon (Mann-Whitney)|||||||0.4933
74040907|NCT01769469|147633948|OTHER|||||||0.5491|||||||Wilcoxon (Mann-Whitney)|||||||0.5491
74040908|NCT01769469|147633949|OTHER|||||||0.5161|||||||Wilcoxon (Mann-Whitney)|||||||0.5161
74040909|NCT01769469|147633950|OTHER|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||||||0.5990
74040910|NCT01769469|147633951|OTHER|||||||0.8579|||||||Wilcoxon (Mann-Whitney)|||||||0.8579
74040911|NCT01769469|147633952|OTHER|||||||0.0719|||||||Wilcoxon (Mann-Whitney)|||||||0.0719
74040912|NCT01769469|147633953|OTHER|||||||0.3148|||||||Wilcoxon (Mann-Whitney)|||||||0.3148
74010168|NCT05082376|147571551|OTHER||Adjusted Mean Difference|6.9|||<|0.0001|TWO_SIDED|95.0|5.8|7.9|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 4 hours post-treatment.||7.9|5.8|<0.0001
74010169|NCT05082376|147571551|OTHER||Adjusted Mean Difference|5.1|||<|0.0001|TWO_SIDED|95.0|4.0|6.2|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 6 hours post-treatment.||6.2|4.0|<0.0001
74010170|NCT05082376|147571551|OTHER||Adjusted Mean Difference|4.7|||<|0.0001|TWO_SIDED|95.0|3.6|5.8|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 8 hours post-treatment.||5.8|3.6|<0.0001
74010171|NCT00290186|147571559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.539||95.0|-1.5|3.3|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.3|-1.5|0.539
74040913|NCT01769469|147633954|OTHER|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.1390
74040914|NCT01769469|147633955|OTHER|||||||0.2726|||||||Wilcoxon (Mann-Whitney)|||||||0.2726
74040915|NCT01769469|147633956|OTHER|||||||0.537|||||||Wilcoxon (Mann-Whitney)|||||||0.5370
74040916|NCT01769469|147633957|OTHER|||||||0.2926|||||||Wilcoxon (Mann-Whitney)|||||||0.2926
74040917|NCT01769469|147633958|OTHER|||||||0.1906|||||||Wilcoxon (Mann-Whitney)|||||||0.1906
74040918|NCT01769469|147633959|OTHER|||||||0.2255|||||||Wilcoxon (Mann-Whitney)|||||||0.2255
74040919|NCT01769469|147633960|OTHER|||||||0.6285|||||||Wilcoxon (Mann-Whitney)|||||||0.6285
74040920|NCT01769469|147633961|OTHER|||||||0.0148|||||||Wilcoxon (Mann-Whitney)|||||||0.0148
74092661|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092662|NCT02504671|147737907|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74040921|NCT01769469|147633962|OTHER|||||||0.0166|||||||Wilcoxon (Mann-Whitney)|||||||0.0166
74040922|NCT01769469|147633963|OTHER|||||||0.0277|||||||Wilcoxon (Mann-Whitney)|||||||0.0277
74010172|NCT00290186|147571560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.921|TWO_SIDED|95.0|-1.6|1.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||1.8|-1.6|0.921
74040923|NCT01769469|147633964|OTHER|||||||0.261|||||||Wilcoxon (Mann-Whitney)|||||||0.2610
74040924|NCT01769469|147633965|OTHER|||||||0.4154|||||||Wilcoxon (Mann-Whitney)|||||||0.4154
74040925|NCT01769469|147633966|OTHER|||||||0.7125|||||||Wilcoxon (Mann-Whitney)|||||||0.7125
74040926|NCT01617187|147634049|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) means difference|-1.3|STANDARD_ERROR_OF_MEAN|2.46||0.6043|TWO_SIDED|95.0|-6.1|3.6||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|Mixed Model Repeated Measures (MMRM)||Asenapine 2.5 mg BID minus Placebo BID|||3.6|-6.1|0.6043
74092663|NCT02504671|147737907|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74040927|NCT01617187|147634049|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-5.5|STANDARD_ERROR_OF_MEAN|2.32||0.0356|TWO_SIDED|95.0|-10.1|-1.0||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-1.0|-10.1|0.0356
74040928|NCT01617187|147634049|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-5.4|STANDARD_ERROR_OF_MEAN|2.86||0.0587|TWO_SIDED|95.0|-11.1|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||0.2|-11.1|0.0587
74040929|NCT01617187|147634050|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.9083|TWO_SIDED|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||0.3|-0.3|0.9083
74040930|NCT01617187|147634050|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0601|TWO_SIDED|95.0|-0.6|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||0.0|-0.6|0.0601
74040931|NCT01617187|147634050|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3898|TWO_SIDED|95.0|-0.5|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||0.2|-0.5|0.3898
74040932|NCT01617187|147634051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||||0.3700
74040933|NCT01617187|147634051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1708||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||||0.1708
74040934|NCT01617187|147634051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||||||0.2620
74040935|NCT01617187|147634052|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0491|TWO_SIDED|95.0|-2.4|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 2.5 mg BID minus Olanzapine 15 mg QD|||-0.0|-2.4|0.0491
74040936|NCT01617187|147634052|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.57||0.0491|TWO_SIDED|95.0|-2.3|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 5 mg BID minus Olanzapine 15 mg QD|||-0.0|-2.3|0.0491
74010173|NCT00290186|147571561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.945|TWO_SIDED|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||5.1|-3.0|0.945
74010174|NCT00290186|147571562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.342|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.2|-5.1|0.342
74010175|NCT00290186|147571563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.149|TWO_SIDED|95.0|-1.6|8.6|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||8.6|-1.6|0.149
74010176|NCT00290186|147571564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.685|TWO_SIDED|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||5.1|-3.0|0.685
74010177|NCT00290186|147571565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.584|TWO_SIDED|95.0|-2.4|3.0|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.0|-2.4|0.584
74010178|NCT00290186|147571566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.498|TWO_SIDED|95.0|-1.5|3.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.7|-1.5|0.498
74010179|NCT00290186|147571567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.945|TWO_SIDED|95.0|-2.3|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.2|-2.3|0.945
74010180|NCT00290186|147571568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.932|TWO_SIDED|95.0|-2.1|2.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.4|-2.1|0.932
74010181|NCT00290186|147571569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.051|TWO_SIDED|95.0|-0.2|4.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||4.7|-0.2|0.051
74010182|NCT00290186|147571570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.648|TWO_SIDED|95.0|-4.0|2.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.8|-4.0|0.648
74010183|NCT00290186|147571571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.473|TWO_SIDED|95.0|-4.7|1.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||1.4|-4.7|0.473
74010184|NCT00290186|147571572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.0||||0.157|TWO_SIDED|95.0|-22.0|114.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.||114|-22|0.157
74010185|NCT00290186|147571573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.876|TWO_SIDED|95.0|-15.0|13.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.||13|-15|0.876
74010186|NCT00290186|147571574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-79.0||||0.167|TWO_SIDED|95.0|-198.0|41.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.||41|-198|0.167
74010187|NCT00290186|147571575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.0||||0.468|TWO_SIDED|95.0|-153.0|77.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.||77|-153|0.468
74010188|NCT04085523|147571579|SUPERIORITY||||||=|0.6004|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.6004
74010189|NCT04085523|147571579|SUPERIORITY||||||=|0.7022|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.7022
74010190|NCT04085523|147571579|SUPERIORITY||||||=|0.0849|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.0849
74010191|NCT04085523|147571579|SUPERIORITY||||||=|0.0218|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.0218
74010192|NCT03697720|147571580|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was .05|t-test, 2 sided|Paired t-test||Paired t-tests were used to compare worst menstrual pain rating across diary day (0-10 numeric rating scale) from baseline and at 6-8 maths followup.||||<0.0001
74010193|NCT03697720|147571581|SUPERIORITY|||||||0.119|||||||t-test, 2 sided|paired t-test||||||.119
74010194|NCT00683163|147571583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.82|TWO_SIDED|95.0|-11.5|9.2|||t-test, 2 sided|||Mean difference in percent change from baseline (Concurrent - Sequential)||9.2|-11.5|0.82
74010195|NCT04456764|147571584|SUPERIORITY|||||||0.55||||||Test for group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.55
74010196|NCT04456764|147571585|SUPERIORITY|||||||0.12||||||group x time interaction|Mixed Models Analysis|random agency and a random participant effect||||||0.12
74010197|NCT04456764|147571586|SUPERIORITY|||||||0.0986|||||||Mixed Models Analysis|Adjusted for clustering.||||||0.0986
74010198|NCT04456764|147571587|SUPERIORITY|||||||0.51||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.51
74010199|NCT04456764|147571588|SUPERIORITY|||||||0.04||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.04
74010200|NCT04456764|147571589|SUPERIORITY|||||||0.02||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.02
74010201|NCT03496012|147571591|SUPERIORITY||Difference in Proportions|2.9|||=|0.354|TWO_SIDED|95.0|-3.1|15.0|||Fisher's Exact|||||15|-3.1|=0.354
74010202|NCT03496012|147571591|SUPERIORITY||Difference in proportions|4.6|||=|0.245|TWO_SIDED|95.0|-1.4|12.8|||Fisher's Exact|||||12.8|-1.4|=0.245
74010203|NCT03496012|147571593|SUPERIORITY||Difference in proportions|16.0|||||TWO_SIDED|95.0|5.3|32.2||||||||32.2|5.3|
74010204|NCT03496012|147571593|SUPERIORITY||Difference in proportions|12.2|||||TWO_SIDED|95.0|3.5|23.0||||||||23|3.5|
74010205|NCT03496012|147571594|SUPERIORITY||Difference in proportions|2.8|||||TWO_SIDED|95.0|-17.2|21.0||||||||21|-17.2|
74010206|NCT03496012|147571594|SUPERIORITY||Difference in proportions|15.3|||||TWO_SIDED|95.0|0.3|30.1||||||||30.1|0.3|
74040937|NCT01617187|147634052|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.51||0.0567|TWO_SIDED|95.0|0.0|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|||2.0|-0.0|0.0567
74040938|NCT01617187|147634052|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.48||0.0391|TWO_SIDED|95.0|0.0|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|||1.9|0.0|0.0391
73879241|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0752|TWO_SIDED|95.0|-3.28|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.16|-3.28|0.0752
73879242|NCT03192176|147297610|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.85||0.3632|TWO_SIDED|95.0|-2.43|0.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.89|-2.43|0.3632
73879243|NCT03192176|147297610|SUPERIORITY||LSMean differencce|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0625|TWO_SIDED|95.0|-3.32|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.09|-3.32|0.0625
73879244|NCT03192176|147297610|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.86||0.6613|TWO_SIDED|95.0|-2.07|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.32|-2.07|0.6613
73879245|NCT03192176|147297610|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.9||0.4209|TWO_SIDED|95.0|-2.48|1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.04|-2.48|0.4209
74010207|NCT00449670|147571622|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.81||||||95.0|0.66|1.01|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 2).||1.01|0.66|
73879246|NCT03192176|147297610|SUPERIORITY||LSMean differencce|-0.9|STANDARD_ERROR_OF_MEAN|0.89||0.3288|TWO_SIDED|95.0|-2.63|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.88|-2.63|0.3288
73879247|NCT03192176|147297610|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.9||0.0202|TWO_SIDED|95.0|-3.86|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.33|-3.86|0.0202
73879248|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.0682|TWO_SIDED|95.0|-3.42|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.12|-3.42|0.0682
73879249|NCT03192176|147297610|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86||0.3912|TWO_SIDED|95.0|-2.44|0.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.96|-2.44|0.3912
73879250|NCT03192176|147297610|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.85||0.4964|TWO_SIDED|95.0|-2.25|1.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.09|-2.25|0.4964
73879251|NCT03192176|147297610|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.84||0.983|TWO_SIDED|95.0|-1.64|1.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.68|-1.64|0.9830
73879252|NCT03192176|147297610|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.89||0.9715|TWO_SIDED|95.0|-1.71|1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.78|-1.71|0.9715
73879253|NCT03192176|147297610|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.87||0.8715|TWO_SIDED|95.0|-1.58|1.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.86|-1.58|0.8715
73879254|NCT03192176|147297610|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.89||0.2233|TWO_SIDED|95.0|-2.83|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.66|-2.83|0.2233
73879255|NCT03192176|147297610|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.89||0.2882|TWO_SIDED|95.0|-2.69|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.80|-2.69|0.2882
73879256|NCT03192176|147297610|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.84||0.8643||95.0|-1.52|1.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.80|-1.52|0.8643
73879257|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0104|TWO_SIDED|95.0|-0.53|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.07|-0.53|0.0104
73879258|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.006|TWO_SIDED|95.0|-0.56|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.09|-0.56|0.0060
73879259|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.71|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.24|-0.71|<0.0001
74092664|NCT02504671|147737907|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092665|NCT02504671|147737907|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092666|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
73879260|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.85|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.38|-0.85|<0.0001
73879261|NCT03192176|147297611|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.6977|TWO_SIDED|95.0|-0.28|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.19|-0.28|0.6977
73879262|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0121|TWO_SIDED|95.0|-0.53|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.07|-0.53|0.0121
74010208|NCT00449670|147571622|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.69|1.06|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 3).||1.06|0.69|
74010209|NCT00449670|147571622|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.68|1.05|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 4).||1.05|0.68|
74010210|NCT00449670|147571622|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|1.05|||||TWO_SIDED|95.0|0.85|1.3|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 3).||1.3|0.85|
74010211|NCT00449670|147571622|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|1.04|||||TWO_SIDED|95.0|0.84|1.29|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 4).||1.29|0.84|
74010212|NCT00449670|147571622|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.8|1.23|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 3 and Lot 4).||1.23|0.8|
74010213|NCT00937937|147571675|SUPERIORITY_OR_OTHER_LEGACY||1-year overall survival estimate|0.38|||||TWO_SIDED|95.0|0.27|0.49||||||one-year overall survival estimate.||0.49|0.27|
74010214|NCT00937937|147571676|SUPERIORITY_OR_OTHER_LEGACY||6-month PFS estimate|0.07|||||TWO_SIDED|95.0|0.03|0.15||||||6-month PFS estimate.||0.15|0.03|
74010215|NCT02248259|147571683|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|113.6|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|100.522|128.376|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||128.376|100.522|
74092667|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
73879263|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0086|TWO_SIDED|95.0|-0.54|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.08|-0.54|0.0086
73879264|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0138|TWO_SIDED|95.0|-0.66|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.08|-0.66|0.0138
73879265|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0014|TWO_SIDED|95.0|-0.78|-0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.19|-0.78|0.0014
74040939|NCT01617187|147634052|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|2.2|STANDARD_ERROR_OF_MEAN|0.58||0.0003|TWO_SIDED|95.0|1.0|3.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||3.3|1.0|0.0003
74040940|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.8|STANDARD_ERROR_OF_MEAN|1.09||0.4849|TWO_SIDED|95.0|-1.4|2.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||2.9|-1.4|0.4849
74040941|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|1.06||0.8902|TWO_SIDED|95.0|-2.2|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.9|-2.2|0.8902
74040942|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.36||0.5826|TWO_SIDED|95.0|-3.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.9|-3.4|0.5826
74040943|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|1.61||0.9271|TWO_SIDED|95.0|-3.3|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||3.0|-3.3|0.9271
74040944|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|1.56||0.1902|TWO_SIDED|95.0|-5.1|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||1.0|-5.1|0.1902
74040945|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|2.0||0.271|TWO_SIDED|95.0|-6.2|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.7|-6.2|0.2710
74040946|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|1.79||0.6773|TWO_SIDED|95.0|-2.8|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||4.3|-2.8|0.6773
74040947|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|1.72||0.2895|TWO_SIDED|95.0|-5.2|1.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.6|-5.2|0.2895
74040948|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.7|STANDARD_ERROR_OF_MEAN|2.18||0.4261|TWO_SIDED|95.0|-6.0|2.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||2.6|-6.0|0.4261
73879266|NCT03192176|147297611|SUPERIORITY||LSMean differencce|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.02|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.43|-1.02|<0.0001
73887961|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|122.6|||<|0.0001|TWO_SIDED|95.0|70.0|175.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||175.1|70.0|<0.0001
74040949|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.3|STANDARD_ERROR_OF_MEAN|2.13||0.5505|TWO_SIDED|95.0|-2.9|5.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||5.5|-2.9|0.5505
74040950|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.03||0.4286|TWO_SIDED|95.0|-5.6|2.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||2.4|-5.6|0.4286
74040951|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|2.56||0.4423|TWO_SIDED|95.0|-7.0|3.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||3.1|-7.0|0.4423
74040952|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|3.2|STANDARD_ERROR_OF_MEAN|2.3||0.1691|TWO_SIDED|95.0|-1.4|7.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||7.7|-1.4|0.1691
74040953|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.17||0.4682|TWO_SIDED|95.0|-5.8|2.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||2.7|-5.8|0.4682
74040954|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|2.71||0.4961|TWO_SIDED|95.0|-7.2|3.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||3.5|-7.2|0.4961
74040955|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.26||0.4697|TWO_SIDED|95.0|-6.1|2.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||2.8|-6.1|0.4697
74040956|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.6|STANDARD_ERROR_OF_MEAN|2.14||0.0947|TWO_SIDED|95.0|-7.8|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.6|-7.8|0.0947
74040957|NCT01617187|147634053|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.9|STANDARD_ERROR_OF_MEAN|2.68||0.0675|TWO_SIDED|95.0|-10.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.4|-10.2|0.0675
74040958|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1736||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.1736
74040959|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1736||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.1736
74040960|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.285||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.2850
74040961|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.3290
74092668|NCT02504671|147737907|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.4|42.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|
74010216|NCT02248259|147571683|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|87.98|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|77.839|99.452|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||99.452|77.839|
74092669|NCT02504671|147737907|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092670|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092671|NCT02504671|147737907|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092672|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092673|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74010217|NCT02248259|147571683|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|89.21|STANDARD_ERROR_OF_MEAN|1.029|||TWO_SIDED|90.0|84.636|94.021|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||94.021|84.636|
74010218|NCT02248259|147571683|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|92.89|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|90.0|88.592|97.396|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis of CD 13896||97.396|88.592|
74010219|NCT02248259|147571683|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|99.61|STANDARD_ERROR_OF_MEAN|1.022|||TWO_SIDED|90.0|95.796|103.584|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||103.584|95.796|
74010220|NCT02248259|147571683|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|104.37|STANDARD_ERROR_OF_MEAN|1.031|||TWO_SIDED|90.0|98.783|110.278|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||110.278|98.783|
74040962|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6938||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.6938
74040963|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1105||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.1105
74092674|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092675|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092676|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092677|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74010221|NCT02248259|147571684|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|93.26|STANDARD_ERROR_OF_MEAN|1.086|||TWO_SIDED|90.0|80.377|108.217|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||108.217|80.377|
74010222|NCT02248259|147571684|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|76.65|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|60.482|97.141|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||97.141|60.482|
74040964|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6804||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.6804
74040965|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9704||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.9704
74040966|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6604||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.6604
74040967|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2447||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.2447
74040968|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4834||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.4834
74092678|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092679|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74040969|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9189||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.9189
74040970|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.437||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.4370
74040971|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2894||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.2894
74040972|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6953||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.6953
74040973|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4892||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.4892
74040974|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1954||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.1954
74040975|NCT01617187|147634054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.7990
74040976|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.4255|TWO_SIDED|95.0|-0.1|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.2|-0.1|0.4255
74040977|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9564|TWO_SIDED|95.0|-0.1|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.1|-0.1|0.9564
74040978|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.6363|TWO_SIDED|95.0|-0.2|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.1|-0.2|0.6363
74040979|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8759|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.8759
74040980|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9598|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.9598
74040981|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.9789|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.9789
74040982|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.4671|TWO_SIDED|95.0|-0.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||0.1|-0.3|0.4671
74040983|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.6359|TWO_SIDED|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.2|-0.3|0.6359
74040984|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5454|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.2|-0.4|0.5454
74040985|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.4188|TWO_SIDED|95.0|-0.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||0.4|-0.2|0.4188
74040986|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.5318|TWO_SIDED|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.2|-0.3|0.5318
74040987|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.5683|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.2|-0.4|0.5683
74040988|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2972|TWO_SIDED|95.0|-0.1|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||0.4|-0.1|0.2972
74040989|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.482|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.2|-0.4|0.4820
74040990|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.9901|TWO_SIDED|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.3|-0.3|0.9901
74040991|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.6682|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.2|-0.4|0.6682
74040992|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1111|TWO_SIDED|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.1|-0.5|0.1111
74040993|NCT01617187|147634055|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.24|TWO_SIDED|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.1|-0.5|0.2400
74040994|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6205||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.6205
74040995|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4829||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.4829
74040996|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3945||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.3945
74040997|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4076||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.4076
74040998|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.969||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.9690
74040999|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.1170
74041000|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5088||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.5088
74041001|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3426||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.3426
73879267|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.19|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.59|-1.19|<0.0001
73879268|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.2831|TWO_SIDED|95.0|-0.46|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.14|-0.46|0.2831
73879269|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0051|TWO_SIDED|95.0|-0.72|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.13|-0.72|0.0051
73879270|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0006|TWO_SIDED|95.0|-0.81|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.22|-0.81|0.0006
74010223|NCT02248259|147571684|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|78.71|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|67.304|92.052|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||92.052|67.304|
74010224|NCT02248259|147571684|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|95.29|STANDARD_ERROR_OF_MEAN|1.093|||TWO_SIDED|90.0|81.092|111.964|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 13896||111.964|81.092|
74010225|NCT02248259|147571684|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|86.79|STANDARD_ERROR_OF_MEAN|1.041|||TWO_SIDED|90.0|80.731|93.309|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||93.309|80.731|
74010226|NCT02248259|147571684|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|107.45|STANDARD_ERROR_OF_MEAN|1.091|||TWO_SIDED|90.0|91.764|125.812|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||125.812|91.764|
73879271|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0058|TWO_SIDED|95.0|-0.83|-0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.14|-0.83|0.0058
73879272|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0004|TWO_SIDED|95.0|-0.97|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.28|-0.97|0.0004
73879273|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.46|-1.14|<0.0001
73879274|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.27|-0.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.57|-1.27|<0.0001
74010227|NCT02248259|147571685|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|113.61|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|100.505|128.427|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||128.427|100.505|
74010228|NCT02248259|147571685|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|87.91|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|77.763|99.37|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||99.370|77.763|
74010229|NCT02248259|147571685|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|89.05|STANDARD_ERROR_OF_MEAN|1.029|||TWO_SIDED|90.0|84.478|93.859|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||93.859|84.478|
73879275|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0807|TWO_SIDED|95.0|-0.66|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||0.04|-0.66|0.0807
73879276|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0014|TWO_SIDED|95.0|-0.91|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.22|-0.91|0.0014
73879277|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17||0.0001|TWO_SIDED|95.0|-1.02|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.34|-1.02|0.0001
74010230|NCT02248259|147571685|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|92.48|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|90.0|88.278|96.889|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 13896||96.889|88.278|
74010231|NCT02248259|147571685|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|99.61|STANDARD_ERROR_OF_MEAN|1.022|||TWO_SIDED|90.0|95.791|103.583|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||103.583|95.791|
74010232|NCT02248259|147571685|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|104.44|STANDARD_ERROR_OF_MEAN|1.031|||TWO_SIDED|90.0|98.861|110.336|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||110.336|98.861|
73879278|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0046|TWO_SIDED|95.0|-0.85|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.16|-0.85|0.0046
74010233|NCT02807480|147571688|OTHER|Correlation between conflict approach behavior and GAD-7 scores at baseline|Pearson correlation|0.23||||0.088|TWO_SIDED||||||Pearson correlation|||||||.088
74010234|NCT02807480|147571688|OTHER||Pearson correlation|-0.2||||0.134|TWO_SIDED||||||Pearson correlation|||Correlation of baseline response time during conflict with baseline GAD-7 scores.||||.134
74010235|NCT02807480|147571688|OTHER||Pearson correlation|0.12||||0.032|TWO_SIDED||||||Pearson correlation|||Correlation of baseline striatum response to points (reward) with baseline GAD-7 scores.||||.032
74010236|NCT02807480|147571688|OTHER||Pearson correlation|-0.12||||0.375|TWO_SIDED||||||Pearson correlation|||Correlation of baseline right amygdala activity during negative images with baseline GAD7 scores||||0.375
74010237|NCT02807480|147571688|OTHER||Pearson correlation|0.06||||0.651|TWO_SIDED||||||Pearson correlation|||Correlation of baseline right dlPFC activity during conflict decision-making with baseline GAD-7 scores.||||.651
74010238|NCT02807480|147571688|OTHER|Correlation of baseline striatum response to negative pictures with baseline GAD-7 scores.|Pearson correlation|-0.35||||0.008|TWO_SIDED||||||Pearson correlation|||||||.008
74010239|NCT02807480|147571689|OTHER||Slope|-1.51||||0.007|TWO_SIDED|95.0|-2.62|-0.41||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0071.|Regression, Linear||Those with lower levels of baseline left amygdala response to positive picture outcomes had favorable GAD symptom improvements in BA and limited GAD symptom improvements in EXP.|Assess left amygdala response to positive picture decision outcomes as a predictor of GAD-7 symptom improvement: time x L. Amyg x treatment-arm interaction||-0.41|-2.62|.007
74010240|NCT02807480|147571689|OTHER||Slope|0.36||||0.238|TWO_SIDED|95.0|-0.24|0.97|||Regression, Linear|||Baseline approach behavior during conflict trials predicting trajectory of GAD-7 symptoms: time main effect||0.97|-0.24|0.238
74010241|NCT02807480|147571689|SUPERIORITY||Slope|-0.49||||0.262|TWO_SIDED|95.0|-1.36|0.37|||Regression, Linear|||Relationship between baseline approach behavior on conflict trials and the trajectory of GAD-7 symptoms: time x treatment interaction effect||0.37|-1.36|.262
74010242|NCT02807480|147571689|OTHER||Slope|2.37||||0.222|TWO_SIDED|95.0|-1.44|6.19|||Regression, Linear|||relationship between baseline response time on conflict trials and trajectory of GAD-7 symptoms: time main effects||6.19|-1.44|.222
74010243|NCT02807480|147571689|SUPERIORITY||Slope|-0.23||||0.942|TWO_SIDED|95.0|-6.48|6.02|||Regression, Linear|||Relationship between baseline average RT during conflict trials on the AAC and trajectory of GAD-7 symptoms: time x treatment interaction effect||6.02|-6.48|.942
74010244|NCT02807480|147571689|OTHER||Slope|-0.05||||0.932|TWO_SIDED|95.0|-1.2|1.1|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with GAD-7 trajectory: time main effects||1.1|-1.2|.932
74010245|NCT02807480|147571689|SUPERIORITY||Slope|-0.08||||0.922|TWO_SIDED|95.0|-1.7|1.53|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with GAD-7 trajectory: time x treatment interaction effects||1.53|-1.7|.922
74010246|NCT02807480|147571689|OTHER||Slope|0.0||||0.998|TWO_SIDED|95.0|-0.99|0.99|||Regression, Linear|||Relationship of right amygdala activity during negative images with GAD-7 trajectory: time main effects||.99|-.99|.998
74010247|NCT02807480|147571689|SUPERIORITY||Slope|-0.88||||0.234|TWO_SIDED|95.0|-2.34|0.57|||Regression, Linear|||Relationship of right amygdala activity during negative images with GAD-7 trajectory: time x treatment interaction||.57|-2.34|.234
74010248|NCT02807480|147571689|OTHER||Slope|-0.03||||0.967|TWO_SIDED|95.0|-1.53|1.47|||Regression, Linear|||Relationship of right dlPFC activity during conflict decisions with GAD-7 trajectory: time main effects||1.47|-1.53|.967
74010249|NCT02807480|147571689|OTHER||Slope|0.74||||0.504|TWO_SIDED|95.0|-1.43|2.91|||Regression, Linear|||Relationship of right dlPFC activity during conflict decision-making with GAD-7 trajectory: time x treatment interaction effect||2.91|-1.43|0.504
74010250|NCT02807480|147571689|OTHER||Slope|-1.68||||0.612|TWO_SIDED|95.0|-8.21|4.84|||Regression, Linear|||Change in conflict arbitration (AAC conflict RTpost-RTpre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_Change interaction||4.84|-8.21|0.612
74010251|NCT02807480|147571689|SUPERIORITY||Slope|5.08||||0.259|TWO_SIDED|95.0|-3.76|13.92|||Regression, Linear|||change in conflict arbitration response time (AAC conflict RTpost-RTpre) predicting trajectories of GAD-7 scores over 10 sessions: RT\_Change x Time x Treatment interaction||13.92|-3.76|.259
74010252|NCT02807480|147571689|OTHER||Slope|-0.53||||0.209|TWO_SIDED|95.0|-1.35|0.3|||Regression, Linear|||Change in behavior (AAC conflict post-pre) in predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.30|-1.35|.209
74010253|NCT02807480|147571689|SUPERIORITY||Slope|1.53||||0.013|TWO_SIDED|95.0|0.33|2.73|||Regression, Linear|||Change in behavior (AAC conflict post-pre) in predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change x Treatment interaction||2.73|0.33|0.013
74041002|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0762||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.0762
74041003|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5531||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.5531
74092680|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092681|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092682|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092683|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092684|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092685|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092686|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74010254|NCT02807480|147571690|OTHER||Slope|-2.95||||0.006|TWO_SIDED|95.0|-5.06|-0.84||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Baseline emotional conflict, a computational parameter reflecting avoidance relative to reward value, as a predictor of the linear trajectory of symptom change over time: time x EC interaction||-0.84|-5.06|0.006
74010255|NCT02807480|147571690|OTHER||Slope|-1.02||||0.003|TWO_SIDED|95.0|-1.68|-0.36|||Regression, Linear|||Assess avoidance behavior on conflict trials as a predictor of PROMIS Anxiety symptom improvement: time x avoidance interaction||-0.36|-1.68|0.003
74010256|NCT02807480|147571690|OTHER||Slope|-1.88||||0.007|TWO_SIDED|95.0|-2.89|-0.87||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0071.|Regression, Linear|||Assess left dlPFC response to baseline negative picture decision outcomes as a predictor of PROMIS Anxiety symptom improvement: time x L. dlPFC interaction||-0.87|-2.89|.007
74010257|NCT02807480|147571690|OTHER||Slope|1.02||||0.003|TWO_SIDED|95.0|0.36|1.68|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms||1.68|0.36|.003
74010258|NCT02807480|147571690|SUPERIORITY||Slope|-0.54||||0.258|TWO_SIDED|95.0|-1.48|0.4|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x treatment x approach behavior interaction||0.4|-1.48|.258
74010259|NCT02807480|147571690|OTHER||Slope|1.3||||0.56|TWO_SIDED|95.0|-3.08|5.69|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x approach behavior interaction||5.69|-3.08|.56
74010260|NCT02807480|147571690|SUPERIORITY||Slope|-1.77||||0.629|TWO_SIDED|95.0|-8.95|5.41|||Regression, Linear|||Relationships between baseline average RT (response time) during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x treatment x RT interaction||5.41|-8.95|.629
74010261|NCT02807480|147571690|OTHER||Slope|-0.21||||0.75|TWO_SIDED|95.0|-1.51|1.09|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS ANXIETY trajectory: time x striatum interaction effects||1.09|-1.51|0.75
74092687|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092688|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74010262|NCT02807480|147571690|SUPERIORITY||Slope|1.27||||0.169|TWO_SIDED|95.0|-0.54|3.09|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS Anxiety trajectory: time x treatment x striatum interaction effects||3.09|-0.54|.169
74010263|NCT02807480|147571690|OTHER||Slope|0.15||||0.792|TWO_SIDED|95.0|-1.0|1.31|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Anxiety trajectory: time x amygdala interaction||1.31|-1.00|0.792
74010264|NCT02807480|147571690|SUPERIORITY||Slope|-0.73||||0.396|TWO_SIDED|95.0|-2.41|0.96|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Anxiety trajectory: time x treatment amygdala interaction||0.96|-2.41|.396
74010265|NCT02807480|147571690|OTHER||Slope|-1.55||||0.009|TWO_SIDED|95.0|-2.7|-0.4|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Anxiety trajectory: time x dlPFC interaction||-0.4|-2.7|.009
74092689|NCT02504671|147737907|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092690|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092691|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092692|NCT02504671|147737907|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092693|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74010266|NCT02807480|147571690|SUPERIORITY||Slope|0.28||||0.724|TWO_SIDED|95.0|-1.28|1.84|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Anxiety trajectory: time x treatment dlPFC interaction||1.84|-1.28|0.724
74010267|NCT02807480|147571690|OTHER||Slope|-4.99||||0.209|TWO_SIDED|95.0|-12.79|2.8|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_change interaction||2.80|-12.79|.209
74010268|NCT02807480|147571690|SUPERIORITY||Slope|12.68||||0.017|TWO_SIDED|95.0|2.23|23.13|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x RT\_change interaction||23.13|2.23|0.017
74010269|NCT02807480|147571690|OTHER||Slope|-0.58||||0.259|TWO_SIDED|95.0|-1.59|0.43|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.43|-1.59|.259
74010270|NCT02807480|147571690|OTHER||Slope|1.07||||0.15|TWO_SIDED|95.0|-0.39|2.54|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||2.54|-0.39|.150
74010271|NCT02807480|147571691|OTHER||Slope|-3.52||||0.001|TWO_SIDED|95.0|-5.57|-1.47||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Assess emotional conflict, a computational parameter reflecting avoidance relative to reward value, as a predictor of PROMIS Depression scores. Time x EC interaction.||-1.47|-5.57|0.001
74010272|NCT02807480|147571691|OTHER||Slope|-1.93|||<|0.001|TWO_SIDED|95.0|-2.91|-0.95||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Baseline left dlPFC response to negative pictures as a predictor of PROMIS depression symptom improvement: time x L. dlFPC interaction.||-0.95|-2.91|<.001
74010273|NCT02807480|147571691|OTHER||Slope|-2.02||||0.036|TWO_SIDED|95.0|-3.9|-0.13||Threshold for statistical significance is 0.05.|Regression, Linear|||Baseline striatum response to monetary outcomes as a predictor of improvement in depressive symptoms: time x treatment x striatum interaction.||-0.13|-3.9|.036
74010274|NCT02807480|147571691|OTHER||Slope|-1.21|||<|0.001|TWO_SIDED|95.0|-1.85|-0.58||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x approach behavior interaction||-0.58|-1.85|<.001
74010275|NCT02807480|147571691|SUPERIORITY||Slope|-0.91||||0.049|TWO_SIDED|95.0|-1.81|0.0|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x treatment x approach behavior interaction||0.00|-1.81|.049
74010276|NCT02807480|147571691|OTHER||Slope|0.6||||0.778|TWO_SIDED|95.0|-3.6|4.81|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x RT interaction||4.81|-3.6|.778
74010277|NCT02807480|147571691|SUPERIORITY||Slope|1.38||||0.696|TWO_SIDED|95.0|-5.56|8.31|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x treatment x RT interaction||8.31|-5.56|.696
74041004|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4875||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.4875
74041005|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.0692
74010278|NCT02807480|147571691|OTHER||Slope|0.44||||0.503|TWO_SIDED|95.0|-0.84|1.71|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS Depression trajectory: time x striatum interaction effects||1.71|-0.84|.503
74010279|NCT02807480|147571691|OTHER||Slope|-0.9||||0.114|TWO_SIDED|95.0|-2.02|0.22|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Depression trajectory: time x amygdala interaction||.22|-2.02|.114
74010280|NCT02807480|147571691|SUPERIORITY||Slope|0.48||||0.561|TWO_SIDED|95.0|-1.15|2.11|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Depression trajectory: time x treatment amygdala interaction||2.11|-1.15|.561
74010281|NCT02807480|147571691|OTHER||Slope|-1.54||||0.007|TWO_SIDED|95.0|-2.66|-0.42|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Depression trajectory: time x dlPFC interaction||-0.42|-2.66|.007
74041006|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7482||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.7482
74041007|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8037||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.8037
74010282|NCT02807480|147571691|SUPERIORITY||Slope|0.65||||0.403|TWO_SIDED|95.0|-0.87|2.17|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Depression trajectory: time x treatment dlPFC interaction||2.17|-0.87|0.403
74010283|NCT02807480|147571691|OTHER||Slope|-1.51||||0.681|TWO_SIDED|95.0|-8.76|5.73|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_change interaction||5.73|-8.76|0.681
74041008|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0859||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.0859
74041009|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.585||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.5850
74041010|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9698||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.9698
74041011|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0132||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.0132
74041012|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7129||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.7129
74041013|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5074||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.5074
74092694|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092695|NCT02504671|147737907|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092696|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092697|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092698|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092699|NCT02504671|147737907|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092700|NCT02504671|147737907|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092701|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 4, Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092702|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092703|NCT02504671|147737908|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092704|NCT02504671|147737908|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092705|NCT02504671|147737908|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74092706|NCT02504671|147737908|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092707|NCT02504671|147737908|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
74092708|NCT02504671|147737908|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
74010284|NCT02807480|147571691|SUPERIORITY||Slope|5.61||||0.264|TWO_SIDED|95.0|-4.24|15.46|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x RT\_change interaction||15.46|-4.24|.264
74010285|NCT02807480|147571691|OTHER||Slope|-0.43||||0.367|TWO_SIDED|95.0|-1.38|0.51|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.51|-1.38|.367
74010286|NCT02807480|147571691|OTHER||Slope|0.88||||0.211|TWO_SIDED|95.0|-0.5|2.25|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||2.25|-0.50|.211
74010287|NCT02807480|147571692|OTHER||Slope|0.74||||0.028|TWO_SIDED|95.0|0.08|1.41|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of SDS score: time x approach behavior interaction||1.41|0.08|0.028
74010288|NCT02807480|147571692|SUPERIORITY||Slope|-0.55||||0.251|TWO_SIDED|95.0|-1.49|0.39|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of SDS symptoms: time x treatment x approach behavior interaction||0.39|-1.49|0.251
74010289|NCT02807480|147571692|OTHER||Slope|-0.26||||0.902|TWO_SIDED|95.0|-4.49|3.96|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of SDS symptoms: time x RT interaction||3.96|-4.49|0.902
74010290|NCT02807480|147571692|SUPERIORITY||Slope|2.23||||0.519|TWO_SIDED|95.0|-4.55|9.01|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of SDS symptoms: time x treatment x RT interaction||9.01|-4.55|.519
74092709|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092710|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092711|NCT02504671|147737908|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
74092712|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092713|NCT02504671|147737908|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092714|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74010291|NCT02807480|147571692|OTHER||Slope|-0.64||||0.326|TWO_SIDED|95.0|-1.92|0.64|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with SDS trajectory: time x striatum interaction effects||0.64|-1.92|.326
74010292|NCT02807480|147571692|SUPERIORITY||Slope|1.26||||0.168|TWO_SIDED|95.0|-0.53|3.05|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with SDS trajectory: time x treatment x striatum interaction effects||3.05|-0.53|.168
74010293|NCT02807480|147571692|OTHER||Slope|-0.5||||0.248|TWO_SIDED|95.0|-1.34|0.35|||Regression, Linear|||Relationship of right amygdala activity during negative images with SDS trajectory: time x amygdala interaction||0.35|-1.34|.248
74010294|NCT02807480|147571692|SUPERIORITY||Slope|0.3||||0.603|TWO_SIDED|95.0|-0.84|1.44|||Regression, Linear|||Relationship of right amygdala activity during negative images with SDS trajectory: time x treatment amygdala interaction||1.44|-0.84|0.603
74010295|NCT02807480|147571692|OTHER||Slope|-0.85||||0.107|TWO_SIDED|95.0|-1.89|0.18|||Regression, Linear|||Relationship of right dlPFC activity during negative images with SDS trajectory: time x dlPFC interaction||0.18|-1.89|.107
74010296|NCT02807480|147571692|SUPERIORITY||Slope|0.16||||0.846|TWO_SIDED|95.0|-1.47|1.8|||Regression, Linear|||Relationship of right dlPFC activity during negative images with SDS trajectory: time x treatment x dlPFC interaction||1.80|-1.47|0.846
74010297|NCT02807480|147571692|OTHER||Slope|-2.26||||0.561|TWO_SIDED|95.0|-9.89|5.37|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x RT\_change interaction||5.37|-9.89|.561
74010298|NCT02807480|147571692|SUPERIORITY||Slope|5.45||||0.297|TWO_SIDED|95.0|-4.8|15.7|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x Treatment x RT\_change interaction||15.70|-4.80|.297
74010299|NCT02807480|147571692|OTHER||Slope|-0.18||||0.712|TWO_SIDED|95.0|-1.15|0.79|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of SDS cores over the 10 sessions: Time x Behavior\_change interaction||0.79|-1.15|.712
74010300|NCT02807480|147571692|SUPERIORITY||Slope|0.56||||0.431|TWO_SIDED|95.0|-0.84|1.97|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||1.97|-0.84|0.431
74010301|NCT02807480|147571693|OTHER||Slope|-6.42||||0.276|TWO_SIDED|95.0|-18.15|5.3|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment PSWQ score: approach behavior main effect||5.30|-18.15|.276
74010302|NCT02807480|147571693|SUPERIORITY||Slope|5.69||||0.52|TWO_SIDED|95.0|-12.12|23.5|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment PSWQ score: treatment x approach behavior interaction||23.50|-12.12|.520
74010303|NCT02807480|147571693|OTHER||Slope|-50.0||||0.199|TWO_SIDED|95.0|-127.65|27.65|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PSWQ score: RT main effect||27.65|-127.65|.199
74010304|NCT02807480|147571693|SUPERIORITY||Slope|93.87||||0.191|TWO_SIDED|95.0|-4.14|236.88|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PSWQ score: treatment x RT interaction||236.88|-4.14|.191
74010305|NCT02807480|147571693|OTHER||Slope|27.35||||0.021|TWO_SIDED|95.0|4.45|50.26|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PSWQ trajectory: striatum main effect||50.26|4.45|0.021
74010306|NCT02807480|147571693|SUPERIORITY||Slope|-5.47||||0.734|TWO_SIDED|95.0|-37.94|27.0|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PSWQ post-treatment: treatment x striatum interaction effects||27.00|-37.94|.734
74010307|NCT02807480|147571693|OTHER||Slope|-9.79||||0.231|TWO_SIDED|95.0|-26.11|6.53|||Regression, Linear|||Relationship of right amygdala activity during negative images with PSWQ post-treatment: amygdala main effect||6.53|-26.11|.231
74010308|NCT02807480|147571693|SUPERIORITY||Slope|8.55||||0.602|TWO_SIDED|95.0|-24.48|41.58|||Regression, Linear|||Relationship of right amygdala activity during negative images with PSWQ post-treatment: treatment amygdala interaction||41.58|-24.48|.602
74010309|NCT02807480|147571693|OTHER||Slope|-19.29||||0.369|TWO_SIDED|95.0|-62.07|23.68|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PSWQ post-treatment: dlPFC main effect||23.68|-62.07|.369
74010310|NCT02807480|147571693|SUPERIORITY||Slope|9.12||||0.684|TWO_SIDED|95.0|-36.05|54.29|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PSWQ post-treatment: treatment x dlPFC interaction||54.29|-36.05|.684
74010311|NCT02807480|147571693|OTHER||Slope|9.6||||0.487|TWO_SIDED|95.0|-18.39|37.59|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of PSWQ cores over the 10 sessions: Behavior\_change main effect||37.59|-18.39|.487
74010312|NCT02807480|147571693|SUPERIORITY||Slope|-46.34||||0.033|TWO_SIDED|95.0|-88.5|-4.18|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of PSWQ scores over the 10 sessions: Treatment x Behavior\_change interaction||-4.18|-88.5|.033
74010313|NCT02807480|147571693|OTHER||Slope|39.53||||0.546|TWO_SIDED|95.0|-94.2|173.85|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of PSWQ scores over the 10 sessions: RT\_change main effect||173.85|-94.2|.546
74010314|NCT02807480|147571693|SUPERIORITY||Slope|-89.96||||0.443|TWO_SIDED|95.0|-327.39|147.67|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of PSWQ scores over the 10 sessions: Treatment x RT\_change interaction||147.67|-327.39|.443
74010315|NCT02807480|147571694|OTHER||Slope|-1.01||||0.357|TWO_SIDED|95.0|-3.22|1.19|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment BDI-II score: approach behavior main effect||1.19|-3.22|.357
74010316|NCT02807480|147571694|SUPERIORITY||Slope|0.37||||0.812|TWO_SIDED|95.0|-2.74|3.47|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment BDI-II score: treatment x approach behavior interaction||3.47|-2.74|.812
74010317|NCT02807480|147571694|OTHER||Slope|2.01||||0.826|TWO_SIDED|95.0|-16.42|20.45|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and post-treatment BDI-II score: RT main effect||20.45|-16.42|.826
74041014|NCT01617187|147634056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.0040
74041015|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.8829|TWO_SIDED|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.8|-0.7|0.8829
74041016|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.5488|TWO_SIDED|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-0.5|0.5488
74041017|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.783|TWO_SIDED|95.0|-1.1|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.8|-1.1|0.7830
74041018|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.45||0.807|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.8|-1.0|0.8070
74041019|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.528|TWO_SIDED|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.6|-1.1|0.5280
74041020|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.57||0.4025|TWO_SIDED|95.0|-1.6|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.6|-1.6|0.4025
74041021|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6471|TWO_SIDED|95.0|-0.8|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.2|-0.8|0.6471
74041022|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.2504|TWO_SIDED|95.0|-1.5|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.5|0.2504
74041023|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.9223|TWO_SIDED|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-1.2|0.9223
74092715|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092716|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092717|NCT02504671|147737908|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
73879279|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0003|TWO_SIDED|95.0|-0.99|-0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.29|-0.99|0.0003
74010318|NCT02807480|147571694|SUPERIORITY||Slope|-2.89||||0.838|TWO_SIDED|95.0|-31.42|25.64|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and post-treatment BDI-II score: treatment x RT interaction||25.64|-31.42|.838
74010319|NCT02807480|147571694|OTHER||Slope|-0.68||||0.776|TWO_SIDED|95.0|-5.51|4.14|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with BDI-II post-treatment: striatum main effect||4.14|-5.51|.776
74010320|NCT02807480|147571694|SUPERIORITY||Slope|-0.69||||0.844|TWO_SIDED|95.0|-7.79|6.4|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with BDI-II post-treatment: treatment x striatum interaction effects||6.40|-7.79|.844
74010321|NCT02807480|147571694|OTHER||Slope|0.88||||0.719|TWO_SIDED|95.0|-4.03|5.79|||Regression, Linear|||Relationship of right amygdala activity during negative images with BDI-II post-treatment: amygdala main effect||5.79|-4.03|.719
74010322|NCT02807480|147571694|SUPERIORITY||Slope|-2.33||||0.464|TWO_SIDED|95.0|-8.74|4.07|||Regression, Linear|||Relationship of right amygdala activity during negative images with BDI-II post-treatment: treatment x amygdala interaction||4.07|-8.74|.464
74010323|NCT02807480|147571694|OTHER||Slope|5.91||||0.135|TWO_SIDED|95.0|-1.93|13.75|||Regression, Linear|||Relationship of right dlPFC activity during negative images with BDI-II post-treatment: dlPFC main effect||13.75|-1.93|.135
74010324|NCT02807480|147571694|SUPERIORITY||Slope|-6.09||||0.158|TWO_SIDED|95.0|-14.65|2.47|||Regression, Linear|||Relationship of right dlPFC activity during negative images with BDI-II post-treatment: treatment x dlPFC interaction||2.47|-14.65|.158
74010325|NCT02807480|147571694|OTHER||Slope|1.16||||0.69|TWO_SIDED|95.0|-4.78|7.11|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of BDI-II cores over the 10 sessions: Behavior\_change main effect||7.11|-4.78|.690
74041024|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.8839|TWO_SIDED|95.0|-1.0|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.2|-1.0|0.8839
74041025|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.54||0.8077|TWO_SIDED|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-1.2|0.8077
74041026|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.68||0.6216|TWO_SIDED|95.0|-1.0|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.7|-1.0|0.6216
74041027|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4248|TWO_SIDED|95.0|-0.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.7|-0.7|0.4248
74041028|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.7667|TWO_SIDED|95.0|-1.3|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.0|-1.3|0.7667
74041029|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.72||0.6282|TWO_SIDED|95.0|-1.1|1.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.8|-1.1|0.6282
74041030|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.65||0.315|TWO_SIDED|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.6|-1.9|0.3150
74092718|NCT02504671|147737908|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092719|NCT02504671|147737908|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092720|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092721|NCT02504671|147737908|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092722|NCT02504671|147737908|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092723|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092724|NCT02504671|147737908|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092725|NCT02504671|147737908|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092726|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092727|NCT02504671|147737908|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092728|NCT02504671|147737908|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092729|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092730|NCT02504671|147737908|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092731|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092732|NCT02504671|147737908|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092733|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092734|NCT02504671|147737908|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092735|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092736|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092737|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.6|||7.9|-2.5|
74092738|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092739|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74010326|NCT02807480|147571694|SUPERIORITY||Slope|-1.37||||0.715|TWO_SIDED|95.0|-8.99|6.25|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of BDI-II scores over the 10 sessions: Treatment x Behavior\_change interaction||6.25|-8.99|.715
74010327|NCT02807480|147571694|OTHER||Slope|5.14||||0.74|TWO_SIDED|95.0|-26.38|36.65|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of BDI-II scores over the 10 sessions: RT\_change main effect||36.65|-26.38|.740
74010328|NCT02807480|147571694|SUPERIORITY||Slope|-0.98||||0.966|TWO_SIDED|95.0|-48.1|46.14|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of BDI-II scores over the 10 sessions: Treatment x RT\_change interaction||46.14|-48.10|.966
74010329|NCT01901575|147571758|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.65|STANDARD_ERROR_OF_MEAN|0.75||0.05|TWO_SIDED|0.15|0.65|0.8|||Fisher Exact|||"null hypothesis:~Remifentanil IVPCA sedation in patients undergoing ablation of the idiopathic ventricular tachycardia does not cause suppression of PVC's"||0.8|0.65|0.05
74010330|NCT03184077|147571791|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
74010331|NCT03184077|147571792|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
74010332|NCT03184077|147571793|SUPERIORITY|||||||0.01||||||This is a calculated p value|Chi-squared|||||||0.01
74010333|NCT03159091|147571801|SUPERIORITY|||||||0.0422|||||||G-test (Chi-square)|||||||0.0422
74010334|NCT03159091|147571802|SUPERIORITY|||||||0.1101|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between initial and 4 weeks total scores row.||||0.1101
74010335|NCT03159091|147571803|SUPERIORITY|||||||0.1373|||||||G-test (Chi-square)|||||||0.1373
74010336|NCT03159091|147571804|SUPERIORITY|||||||0.087|||||||Wilcoxon (Mann-Whitney)|||||||0.0870
74010337|NCT03159091|147571805|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73879280|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.45|-1.14|<0.0001
73879281|NCT03192176|147297611|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.70|-1.14|<0.0001
73879282|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0209|TWO_SIDED|95.0|-0.77|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.06|-0.77|0.0209
73879283|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.6|STANDARD_DEVIATION|0.18||0.0011|TWO_SIDED|95.0|-0.93|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.24|-0.93|0.0011
74010338|NCT00262522|147571806|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test stratified by dosing regimen was used to assess the null hypothesis of no difference between the tablet and soft gel capsule (SGC). Sample size was 600 subjects (150 each in the 4 groups). Based on a projected 48% reporting treatment-emergent diarrhea in the QD arm and 32% in the BID arm within the SGC group, with a 12% reduction in the corresponding tablet groups, this sample size provided 80% power to determine a difference between the tablet and SGC.||||>0.100
74010339|NCT00262522|147571807|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|1.3||||0.715||95.0|-5.1|7.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||7.8|-5.1|0.715
74010340|NCT00262522|147571808|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|-4.3||||0.249||95.0|-11.5|2.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||2.8|-11.5|0.249
74041031|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.61||0.1908|TWO_SIDED|95.0|-2.0|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.4|-2.0|0.1908
74041032|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.77||0.3128|TWO_SIDED|95.0|-2.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.7|-2.3|0.3128
73879284|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.07|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.38|-1.07|<0.0001
73879285|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0956|TWO_SIDED|95.0|-0.67|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.67|0.0956
73879286|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|95.0|-0.89|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.89|0.0050
74041033|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.8812|TWO_SIDED|95.0|-1.5|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.3|-1.5|0.8812
74041034|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69||0.1143|TWO_SIDED|95.0|-2.4|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-2.4|0.1143
73879287|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.18|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.45|-1.18|<0.0001
73879288|NCT03192176|147297611|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.4|-0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.65|-1.40|<0.0001
73879289|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0915|TWO_SIDED|95.0|-0.69|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.69|0.0915
74092740|NCT02504671|147737908|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74092741|NCT02504671|147737908|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74092742|NCT02504671|147737908|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
74092743|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
74092744|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092745|NCT02504671|147737908|OTHER||5.4|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092746|NCT02504671|147737908|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
74092747|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092748|NCT02504671|147737908|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092749|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092750|NCT02504671|147737908|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74010341|NCT00262522|147571809|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||ANOVA|||||||0.269
74010342|NCT03462719|147571812|SUPERIORITY||Hazard Ratio (HR)|0.216|||<|0.0001|TWO_SIDED|95.0|0.131|0.357|||Log Rank|||||0.357|0.131|<0.0001
74010343|NCT03740165|147571827|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0002|TWO_SIDED|95.0|0.53|0.83||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||0.83|0.53|0.0002
74010344|NCT03740165|147571827|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3339|TWO_SIDED|95.0|0.77|1.19||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.19|0.77|0.3339
74010345|NCT03740165|147571828|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.84||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.84|0.61|<0.0001
74010346|NCT03740165|147571828|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5527|TWO_SIDED|95.0|0.87|1.18||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.18|0.87|0.5527
74010347|NCT03740165|147571829|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4314|TWO_SIDED|95.0|0.75|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.27|0.75|0.4314
74010348|NCT03740165|147571829|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.3107|TWO_SIDED|95.0|0.72|1.22||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.22|0.72|0.3107
74010349|NCT03740165|147571830|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6716|TWO_SIDED|95.0|0.87|1.25||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.25|0.87|0.6716
74010350|NCT03740165|147571830|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7448|TWO_SIDED|95.0|0.89|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.27|0.89|0.7448
74010351|NCT03740165|147571831|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0012|TWO_SIDED|95.0|0.5|0.86||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||0.86|0.50|0.0012
74041035|NCT01617187|147634057|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.84||0.4418|TWO_SIDED|95.0|-2.3|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.0|-2.3|0.4418
74041036|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.4||0.216|TWO_SIDED|95.0|-0.3|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.3|-0.3|0.2160
74092751|NCT02504671|147737908|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092752|NCT02504671|147737908|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092753|NCT02504671|147737908|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092754|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092755|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092756|NCT02504671|147737908|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
74092757|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092758|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092759|NCT02504671|147737908|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
74092760|NCT02504671|147737908|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092761|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092762|NCT02504671|147737908|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
74092763|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092764|NCT02504671|147737908|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
74092765|NCT02504671|147737908|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
74092766|NCT02504671|147737909|OTHER||Mean Difference (Net)|-4.09||||0.05|TWO_SIDED|95.0|-8.18|0.0||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, SDAI|||0.00|-8.18|0.050
74092767|NCT02504671|147737909|OTHER||Mean Difference (Net)|-3.66||||0.086|TWO_SIDED|95.0|-7.84|0.52||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||0.52|-7.84|0.086
74092768|NCT02504671|147737909|OTHER||Mean Difference (Net)|-4.33||||0.038|TWO_SIDED|95.0|-8.43|-0.23||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-0.23|-8.43|0.038
74041037|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.9494|TWO_SIDED|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.8|-0.7|0.9494
74041038|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.1834|TWO_SIDED|95.0|-1.6|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.3|-1.6|0.1834
74041039|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6347|TWO_SIDED|95.0|-0.8|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.3|-0.8|0.6347
74041040|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6917|TWO_SIDED|95.0|-1.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.8|-1.2|0.6917
74041041|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.66||0.1431|TWO_SIDED|95.0|-2.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.3|-2.3|0.1431
74092769|NCT02504671|147737909|OTHER||Mean Difference (Net)|-4.06||||0.119|TWO_SIDED|95.0|-9.18|1.05||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||1.05|-9.18|0.119
74041042|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.61||0.6267|TWO_SIDED|95.0|-0.9|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.5|-0.9|0.6267
74092770|NCT02504671|147737909|OTHER||Mean Difference (Net)|-4.72||||0.071|TWO_SIDED|95.0|-9.85|0.4||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||0.40|-9.85|0.071
74092771|NCT02504671|147737909|OTHER||Mean Difference (Net)|-5.48||||0.034|TWO_SIDED|95.0|-10.53|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-0.42|-10.53|0.034
74092772|NCT02504671|147737909|OTHER||Mean Difference (Net)|-6.78||||0.023|TWO_SIDED|95.0|-12.61|-0.94||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-0.94|-12.61|0.023
74092773|NCT02504671|147737909|OTHER||Mean Difference (Net)|-7.28||||0.014|TWO_SIDED|95.0|-13.09|-1.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-1.47|-13.09|0.014
73879290|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0378|TWO_SIDED|95.0|-0.75|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.02|-0.75|0.0378
73879291|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0053|TWO_SIDED|95.0|-0.89|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.89|0.0053
73879292|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0614|TWO_SIDED|95.0|-0.83|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.08|-0.83|0.0614
73879293|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.92|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.18|-0.92|0.0040
73879294|NCT03192176|147297611|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.33|-0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.58|-1.33|<0.0001
73879295|NCT03192176|147297611|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.47|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.71|-1.47|<0.0001
74010352|NCT03740165|147571831|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4366|TWO_SIDED|95.0|0.75|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.27|0.75|0.4366
73879296|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0967|TWO_SIDED|95.0|-0.7|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.06|-0.70|0.0967
73879297|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0063|TWO_SIDED|95.0|-0.9|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.15|-0.90|0.0063
73879298|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.13|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.38|-1.13|<0.0001
73879299|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0632|TWO_SIDED|95.0|-0.75|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.02|-0.75|0.0632
73879300|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.0|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.23|-1.00|0.0020
73879301|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.29|-0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.51|-1.29|<0.0001
73879302|NCT03192176|147297611|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.48|-0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.69|-1.48|<0.0001
73879303|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0308|TWO_SIDED|95.0|-0.82|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.04|-0.82|0.0308
73879304|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0105|TWO_SIDED|95.0|-0.89|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.12|-0.89|0.0105
73887962|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|295.3|||<|0.0001|TWO_SIDED|95.0|228.3|362.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||362.2|228.3|<0.0001
73879305|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.03|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.26|-1.03|0.0010
73879306|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1469|TWO_SIDED|95.0|-0.69|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.11|-0.69|0.1469
73879307|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0315|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.04|-0.84|0.0315
73879308|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.18|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.38|-1.18|0.0002
73879309|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.26|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.43|-1.26|<0.0001
74010353|NCT03740165|147571832|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0008|TWO_SIDED|95.0|0.61|0.89||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.89|0.61|0.0008
74041043|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.726|TWO_SIDED|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-1.3|0.7260
73879310|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4494|TWO_SIDED|95.0|-0.56|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.25|-0.56|0.4494
73879311|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0595|TWO_SIDED|95.0|-0.79|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.02|-0.79|0.0595
73879312|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0065|TWO_SIDED|95.0|-0.96|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.16|-0.96|0.0065
73879313|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0745|TWO_SIDED|95.0|-0.77|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.04|-0.77|0.0745
73879314|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.054|TWO_SIDED|95.0|-0.8|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.01|-0.80|0.0540
73879315|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0001|TWO_SIDED|95.0|-1.22|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.41|-1.22|0.0001
73879316|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.26|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.43|-1.26|<0.0001
73879317|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.5317|TWO_SIDED|95.0|-0.54|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.28|-0.54|0.5317
73887963|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|69.6||||0.0416|TWO_SIDED|95.0|2.7|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||136.5|2.7|0.0416
74041044|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.74||0.3326|TWO_SIDED|95.0|-2.2|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.7|-2.2|0.3326
74041045|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.72||0.4575|TWO_SIDED|95.0|-0.9|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.9|-0.9|0.4575
74041046|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.68||0.493|TWO_SIDED|95.0|-1.8|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-1.8|0.4930
74041047|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.86||0.1886|TWO_SIDED|95.0|-2.8|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.6|-2.8|0.1886
74092774|NCT02504671|147737909|OTHER||Mean Difference (Net)|-9.23||||0.002|TWO_SIDED|95.0|-14.99|-3.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-3.47|-14.99|0.002
73879318|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0424|TWO_SIDED|95.0|-0.83|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.01|-0.83|0.0424
74092775|NCT02504671|147737909|OTHER||Mean Difference (Net)|-5.65||||0.063|TWO_SIDED|95.0|-11.62|0.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||0.32|-11.62|0.063
74092776|NCT02504671|147737909|OTHER||Mean Difference (Net)|-6.29||||0.04|TWO_SIDED|95.0|-12.28|-0.3||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-0.30|-12.28|0.040
73879319|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0134|TWO_SIDED|95.0|-0.91|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.11|-0.91|0.0134
74092777|NCT02504671|147737909|OTHER||Mean Difference (Net)|-6.79||||0.024|TWO_SIDED|95.0|-12.69|-0.9||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-0.90|-12.69|0.024
74092778|NCT02504671|147737909|OTHER||Mean Difference (Net)|-6.58||||0.05|TWO_SIDED|95.0|-13.15|-0.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-0.01|-13.15|0.050
74092779|NCT02504671|147737909|OTHER||Mean Difference (Net)|-9.15||||0.006|TWO_SIDED|95.0|-15.71|-2.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-2.60|-15.71|0.006
74092780|NCT02504671|147737909|OTHER||Mean Difference (Net)|-8.86||||0.007|TWO_SIDED|95.0|-15.32|-2.41||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-2.41|-15.32|0.007
74092781|NCT02504671|147737909|OTHER||Mean Difference (Net)|-6.91||||0.074|TWO_SIDED|95.0|-14.49|0.68||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||0.68|-14.49|0.074
74092782|NCT02504671|147737909|OTHER||Mean Difference (Net)|-10.37||||0.008|TWO_SIDED|95.0|-17.99|-2.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-2.74|-17.99|0.008
73879320|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.04|-0.84|0.0300
73879321|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0605|TWO_SIDED|95.0|-0.78|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.02|-0.78|0.0605
74092783|NCT02504671|147737909|OTHER||Mean Difference (Net)|-14.15|||<|0.001|TWO_SIDED|95.0|-21.64|-6.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-6.67|-21.64|<0.001
74092784|NCT02504671|147737909|OTHER||Mean Difference (Net)|-1.88||||0.656|TWO_SIDED|95.0|-10.19|6.43||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||6.43|-10.19|0.656
73879322|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2||0.0001|TWO_SIDED|95.0|-1.2|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.40|-1.20|0.0001
74092785|NCT02504671|147737909|OTHER||Mean Difference (Net)|-7.0||||0.093|TWO_SIDED|95.0|-15.19|1.19||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||1.19|-15.19|0.093
74092786|NCT02504671|147737909|OTHER||Mean Difference (Net)|-7.26||||0.076|TWO_SIDED|95.0|-15.3|0.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||0.78|-15.30|0.076
74092787|NCT02504671|147737909|OTHER||Mean Difference (Net)|0.8||||0.86|TWO_SIDED|95.0|-8.14|9.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||9.74|-8.14|0.860
74092788|NCT02504671|147737909|OTHER||Mean Difference (Net)|-5.71||||0.196|TWO_SIDED|95.0|-14.4|2.99||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.99|-14.40|0.196
74092789|NCT02504671|147737909|OTHER||Mean Difference (Net)|-6.0||||0.164|TWO_SIDED|95.0|-14.48|2.48||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.48|-14.48|0.164
74092790|NCT02504671|147737909|OTHER||Mean Difference (Net)|-10.65||||0.066|TWO_SIDED|95.0|-21.99|0.69||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||0.69|-21.99|0.066
74092791|NCT02504671|147737909|OTHER||Mean Difference (Net)|-16.37||||0.003|TWO_SIDED|95.0|-27.25|-5.49||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-5.49|-27.25|0.003
74092792|NCT02504671|147737909|OTHER||Mean Difference (Net)|-15.67||||0.004|TWO_SIDED|95.0|-26.3|-5.03||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-5.03|-26.30|0.004
74010354|NCT03740165|147571832|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7174|TWO_SIDED|95.0|0.88|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.27|0.88|0.7174
74010355|NCT03740165|147571833|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0228|TWO_SIDED|95.0|0.62|1.0||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.00|0.62|0.0228
74010356|NCT03740165|147571833|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3935|TWO_SIDED|95.0|0.77|1.22||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.22|0.77|0.3935
74010357|NCT03740165|147571834|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0573|TWO_SIDED|95.0|0.74|1.03||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.03|0.74|0.0573
74010358|NCT03740165|147571834|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7234|TWO_SIDED|95.0|0.89|1.23||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.23|0.89|0.7234
74010359|NCT03740165|147571835|SUPERIORITY||Difference in Least Squares Means (LSM)|0.26||||0.8481|TWO_SIDED|95.0|-2.44|2.97|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.97|-2.44|0.8481
74010360|NCT03740165|147571835|SUPERIORITY||Difference in LS Means|-1.1||||0.4335|TWO_SIDED|95.0|-3.87|1.66|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||1.66|-3.87|0.4335
74010361|NCT03740165|147571836|SUPERIORITY||Difference in Least Squares Means (LSM)|0.14||||0.9024|TWO_SIDED|95.0|-2.15|2.44|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.44|-2.15|0.9024
74010362|NCT03740165|147571836|SUPERIORITY||Difference in Least Squares Means (LSM)|-0.08||||0.9478|TWO_SIDED|95.0|-2.47|2.31|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.31|-2.47|0.9478
74010363|NCT03740165|147571837|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2644|TWO_SIDED|95.0|0.73|1.17||One-sided p-value based on log-rank test stratified by surgery (planned interval debulking versus R0 following primary debulking versus R1 following primary debulking), bevacizumab use (yes versus no), and PD-L1 status (CPS\<10 vs CPS≥10).|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by surgery (planned interval vs R0 following primary vs R1 following primary debulking), bevacizumab use (Yes vs No), PD-L1 status (CPS\<10 vs CPS≥10)|||1.17|0.73|0.2644
74010364|NCT03740165|147571837|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1953|TWO_SIDED|95.0|0.71|1.14||One-sided p-value based on log-rank test stratified by surgery (planned interval debulking versus R0 following primary debulking versus R1 following primary debulking), bevacizumab use (yes versus no), and PD-L1 status (CPS\<10 vs CPS≥10).|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by surgery (planned interval vs R0 following primary vs R1 following primary debulking), bevacizumab use (Yes vs No), PD-L1 status (CPS\<10 vs CPS≥10)|||1.14|0.71|0.1953
74010365|NCT03740165|147571838|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5188|TWO_SIDED|95.0|0.77|1.3||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.30|0.77|0.5188
74041048|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.2643|TWO_SIDED|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.5|-0.7|0.2643
74041049|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.76||0.3516|TWO_SIDED|95.0|-2.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.8|-2.2|0.3516
74041050|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.94||0.2068|TWO_SIDED|95.0|-3.1|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.7|-3.1|0.2068
74041051|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.82||0.7284|TWO_SIDED|95.0|-1.3|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.9|-1.3|0.7284
74041052|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.77||0.2698|TWO_SIDED|95.0|-2.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.7|-2.4|0.2698
74041053|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.96||0.151|TWO_SIDED|95.0|-3.3|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.5|-3.3|0.1510
74041054|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.88||0.8039|TWO_SIDED|95.0|-2.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.5|-2.0|0.8039
74041055|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|0.83||0.0306|TWO_SIDED|95.0|-3.5|-0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||-0.2|-3.5|0.0306
74041056|NCT01617187|147634058|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.1|STANDARD_ERROR_OF_MEAN|1.03||0.0406|TWO_SIDED|95.0|-4.1|-0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||-0.1|-4.1|0.0406
74041057|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.7819|TWO_SIDED|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.5|-1.1|0.7819
74041058|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.703|TWO_SIDED|95.0|-1.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-1.5|0.7030
74041059|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.83||0.952|TWO_SIDED|95.0|-1.7|1.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.6|-1.7|0.9520
74041060|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.7907|TWO_SIDED|95.0|-2.1|1.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.6|-2.1|0.7907
74041061|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.91||0.1391|TWO_SIDED|95.0|-3.1|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.4|-3.1|0.1391
74041062|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.18||0.4901|TWO_SIDED|95.0|-3.1|1.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.5|-3.1|0.4901
74041063|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|1.0||0.8079|TWO_SIDED|95.0|-1.7|2.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||2.2|-1.7|0.8079
74041064|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.95||0.3889|TWO_SIDED|95.0|-2.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.1|-2.7|0.3889
74041065|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.21||0.3907|TWO_SIDED|95.0|-3.4|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-3.4|0.3907
74041066|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|1.15||0.5363|TWO_SIDED|95.0|-1.5|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||3.0|-1.5|0.5363
74041067|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|1.09||0.5075|TWO_SIDED|95.0|-2.9|1.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.4|-2.9|0.5075
74041068|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.38||0.4526|TWO_SIDED|95.0|-3.7|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.7|-3.7|0.4526
74041069|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.8|STANDARD_ERROR_OF_MEAN|1.26||0.1548|TWO_SIDED|95.0|-0.7|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||4.3|-0.7|0.1548
74041070|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|1.19||0.6589|TWO_SIDED|95.0|-2.9|1.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.8|-2.9|0.6589
74041071|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.48||0.5171|TWO_SIDED|95.0|-3.9|2.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||2.0|-3.9|0.5171
74041072|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|1.2||0.3133|TWO_SIDED|95.0|-3.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.2|-3.6|0.3133
74041073|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|1.13||0.1723|TWO_SIDED|95.0|-3.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.7|-3.8|0.1723
74041074|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.6|STANDARD_ERROR_OF_MEAN|1.42||0.0663|TWO_SIDED|95.0|-5.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.2|-5.4|0.0663
74041075|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|1.32||0.5128|TWO_SIDED|95.0|-3.5|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.7|-3.5|0.5128
74041076|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|1.24||0.0842|TWO_SIDED|95.0|-4.6|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-4.6|0.0842
74041077|NCT01617187|147634059|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.52||0.1217|TWO_SIDED|95.0|-5.4|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.6|-5.4|0.1217
74041078|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|0.39||0.0584|TWO_SIDED|95.0|0.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.5|-0.0|0.0584
74041079|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.38||0.5197|TWO_SIDED|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-0.5|0.5197
74041080|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.49||0.9693|TWO_SIDED|95.0|-0.9|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.0|-0.9|0.9693
74041081|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.56||0.6161|TWO_SIDED|95.0|-0.8|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.4|-0.8|0.6161
74041082|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.54||0.788|TWO_SIDED|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.9|-1.2|0.7880
73879323|NCT03192176|147297611|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.38|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.56|-1.38|<0.0001
73879324|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1848|TWO_SIDED|95.0|-0.68|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||0.13|-0.68|0.1848
73879325|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0321|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.04|-0.84|0.0321
73879326|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0025|TWO_SIDED|95.0|-1.01|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.22|-1.01|0.0025
74010366|NCT03740165|147571838|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5091|TWO_SIDED|95.0|0.77|1.3||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.30|0.77|0.5091
74041083|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.7||0.5526|TWO_SIDED|95.0|-1.8|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.0|-1.8|0.5526
74041084|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.67||0.7647|TWO_SIDED|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.5|-1.1|0.7647
73879327|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0441|TWO_SIDED|95.0|-0.81|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.01|-0.81|0.0441
74092793|NCT02504671|147737909|OTHER||Mean Difference (Net)|-4.78||||0.024|TWO_SIDED|95.0|-8.91|-0.65||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-0.65|-8.91|0.024
74092794|NCT02504671|147737909|OTHER||Mean Difference (Net)|-7.77|||<|0.001|TWO_SIDED|95.0|-11.84|-3.7||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-3.70|-11.84|<0.001
73879328|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0422|TWO_SIDED|95.0|-0.82|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.01|-0.82|0.0422
73879329|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.27|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.45|-1.27|<0.0001
73879330|NCT03192176|147297611|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.44|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.62|-1.44|<0.0001
74041085|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.64||0.89|TWO_SIDED|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.3|-1.2|0.8900
74041086|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.81||0.7097|TWO_SIDED|95.0|-1.9|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-1.9|0.7097
74041087|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.76||0.4601|TWO_SIDED|95.0|-0.9|2.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||2.1|-0.9|0.4601
74041088|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.72||0.6288|TWO_SIDED|95.0|-1.8|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.1|-1.8|0.6288
74092795|NCT02504671|147737909|OTHER||Mean Difference (Net)|-6.67||||0.01|TWO_SIDED|95.0|-11.74|-1.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-1.60|-11.74|0.010
73879331|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1464|TWO_SIDED|95.0|-0.71|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.11|-0.71|0.1464
74041089|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.91||0.6099|TWO_SIDED|95.0|-2.3|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.3|-2.3|0.6099
74041090|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.9|STANDARD_ERROR_OF_MEAN|0.82||0.279|TWO_SIDED|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.5|-0.7|0.2790
74092796|NCT02504671|147737909|OTHER||Mean Difference (Net)|-6.85||||0.008|TWO_SIDED|95.0|-11.91|-1.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-1.78|-11.91|0.008
74041091|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.77||0.4253|TWO_SIDED|95.0|-2.1|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.9|-2.1|0.4253
74041092|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.96||0.3014|TWO_SIDED|95.0|-2.9|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.9|-2.9|0.3014
74041093|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.972|TWO_SIDED|95.0|-1.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.7|-1.7|0.9720
74041094|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4758|TWO_SIDED|95.0|-2.2|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||1.0|-2.2|0.4758
74041095|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.03||0.4419|TWO_SIDED|95.0|-2.8|1.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||1.2|-2.8|0.4419
74041096|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.91||0.4762|TWO_SIDED|95.0|-2.4|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-2.4|0.4762
74041097|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.86||0.1046|TWO_SIDED|95.0|-3.1|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-3.1|0.1046
74041098|NCT01617187|147634060|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|1.06||0.1411|TWO_SIDED|95.0|-3.7|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.5|-3.7|0.1411
74041099|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.2754|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.4|-1.2|0.2754
74041100|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39||0.85|TWO_SIDED|95.0|-0.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.7|-0.8|0.8500
74092797|NCT02504671|147737909|OTHER||Mean Difference (Net)|-8.44||||0.004|TWO_SIDED|95.0|-14.2|-2.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-2.67|-14.20|0.004
74092798|NCT02504671|147737909|OTHER||Mean Difference (Net)|-12.51|||<|0.001|TWO_SIDED|95.0|-18.26|-6.75||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-6.75|-18.26|<0.001
74092799|NCT02504671|147737909|OTHER||Mean Difference (Net)|-7.0||||0.022|TWO_SIDED|95.0|-12.99|-1.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-1.01|-12.99|0.022
74092800|NCT02504671|147737909|OTHER||Mean Difference (Net)|-10.16|||<|0.001|TWO_SIDED|95.0|-16.07|-4.24||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-4.24|-16.07|<0.001
74092801|NCT02504671|147737909|OTHER||Mean Difference (Net)|-11.18|||<|0.001|TWO_SIDED|95.0|-17.7|-4.66||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-4.66|-17.70|<0.001
74092802|NCT02504671|147737909|OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-20.57|-7.44||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-7.44|-20.57|<0.001
74092803|NCT02504671|147737909|OTHER||Mean Difference (Net)|-9.68||||0.013|TWO_SIDED|95.0|-17.26|-2.11||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-2.11|-17.26|0.013
74092804|NCT02504671|147737909|OTHER||Mean Difference (Net)|-16.86|||<|0.001|TWO_SIDED|95.0|-24.39|-9.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-9.32|-24.39|<0.001
74092805|NCT02504671|147737909|OTHER||Mean Difference (Net)|-6.03||||0.149|TWO_SIDED|95.0|-14.24|2.18||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||2.18|-14.24|0.149
74092806|NCT02504671|147737909|OTHER||Mean Difference (Net)|-9.43||||0.019|TWO_SIDED|95.0|-17.32|-1.55||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||-1.55|-17.32|0.019
74092807|NCT02504671|147737909|OTHER||Mean Difference (Net)|-6.59||||0.138|TWO_SIDED|95.0|-15.32|2.14||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.14|-15.32|0.138
74041101|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.8439|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.9|-1.1|0.8439
74041102|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.51||0.4741|TWO_SIDED|95.0|-1.4|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.6|-1.4|0.4741
74041103|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.2158|TWO_SIDED|95.0|-1.6|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.4|-1.6|0.2158
74041104|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.63||0.506|TWO_SIDED|95.0|-1.7|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.8|-1.7|0.5060
74041105|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.56||0.9956|TWO_SIDED|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.1|-1.1|0.9956
74041106|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.53||0.1624|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.3|-1.8|0.1624
74041107|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.68||0.7662|TWO_SIDED|95.0|-1.5|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.1|-1.5|0.7662
74092808|NCT02504671|147737909|OTHER||Mean Difference (Net)|-8.7||||0.04|TWO_SIDED|95.0|-16.99|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||-0.42|-16.99|0.040
74092809|NCT02504671|147737909|OTHER||Mean Difference (Net)|-15.88||||0.005|TWO_SIDED|95.0|-26.77|-4.98||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-4.98|-26.77|0.005
74010367|NCT03740165|147571839|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.8||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.80|0.59|<0.0001
74010368|NCT03740165|147571839|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1206|TWO_SIDED|95.0|0.79|1.06||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.06|0.79|0.1206
74010369|NCT03740165|147571840|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0853||95.0|0.76|1.05||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.05|0.76|0.0853
74010370|NCT03740165|147571840|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7165||95.0|0.89|1.23||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.23|0.89|0.7165
74010371|NCT03740165|147571841|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0442||95.0|0.76|1.02||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.02|0.76|0.0442
74010372|NCT03740165|147571841|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.9565||95.0|0.98|1.31||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.31|0.98|0.9565
74010373|NCT03740165|147571842|SUPERIORITY||Difference in Percentage|3.7||||0.0318|TWO_SIDED|95.0|-0.3|7.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|t-test, 1 sided||Based on Miettinen \& Nurminen method stratified by bevacizumab use (Yes vs No) and PD-L1 CPS (\<10 vs ≥10)|||7.3|-0.3|0.0318
74010374|NCT04272892|147571845|SUPERIORITY||Mean Difference (Final Values)|3.35|||<|0.021|TWO_SIDED|||||p values are calculated for original data (complete case) and each of the 5 imputed datasets. The p value range was 0.002 - 0.020. This is not multiple statistical analyses- it is just one with multiple imputations.|ANCOVA|Degrees of freedom for original data (complete case): 1,64. Degrees of freedom for imputed datasets: 1,80||||||<0.021
74010375|NCT04272892|147571846|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.059|TWO_SIDED|95.0|-0.106|5.822|||ANCOVA|ANCOVA of score at 8 week follow up with baseline score as covariate, effect of group||||5.822|-.106|0.059
74092810|NCT02504671|147737909|OTHER||Mean Difference (Net)|-20.87|||<|0.001|TWO_SIDED|95.0|-31.2|-10.53||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-10.53|-31.20|<0.001
74092811|NCT02504671|147737910|OTHER||Mean Difference (Net)|-3.84||||0.063|TWO_SIDED|95.0|-7.89|0.2||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.20|-7.89|0.063
74092812|NCT02504671|147737910|OTHER||Mean Difference (Net)|-3.84||||0.067|TWO_SIDED|95.0|-7.95|0.28||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.28|-7.95|0.067
74092813|NCT02504671|147737910|OTHER||Mean Difference (Net)|-4.43||||0.032|TWO_SIDED|95.0|-8.46|-0.39||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||-0.39|-8.46|0.032
74010376|NCT04272892|147571847|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.596|TWO_SIDED|95.0|-3.5|6.0|||ANCOVA|ANCOVA of sleep fragmentation at post-intervention with baseline as covariate, effect of group||||6.0|-3.5|0.596
74010377|NCT04272892|147571848|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.031|TWO_SIDED|95.0|0.431|8.612|||ANCOVA|ANCOVA of sleep fragmentation at 8 week follow up with baseline as covariate, effect of group||||8.612|.431|0.031
74010378|NCT04272892|147571849|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.885|TWO_SIDED|95.0|-7.8|9.1|||ANCOVA|ANCOVA of wake after sleep onset post-intervention with baseline as covariate, effect of group||||9.1|-7.8|0.885
74010379|NCT04272892|147571850|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.077|TWO_SIDED|95.0|-1.0|17.0|||ANCOVA|ANCOVA of wake after sleep onset at 8 week follow up with baseline as covariate, effect of group||||17|-1|0.077
74010380|NCT04272892|147571851|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.014|TWO_SIDED|95.0|2.0|18.0|||ANCOVA|ANCOVA of sleep onset latency (median of 7 nights) at end of intervention with baseline as covariate, effect of group||||18|2|0.014
74010381|NCT04272892|147571852|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.03|TWO_SIDED|95.0|0.18|3.5|||ANCOVA|ANCOVA of PHQ9 score post-intervention with baseline as covariate, effect of group||||3.5|.18|0.03
74010382|NCT04272892|147571853|SUPERIORITY||Mean Difference (Final Values)|2.29||||0.036|TWO_SIDED|95.0|0.149|4.44|||ANCOVA|ANCOVA of PHQ9 score at 8 week follow up with baseline as covariate, effect of group||||4.44|.149|0.036
74010383|NCT04272892|147571854|SUPERIORITY||Mean Difference (Final Values)|1.61||||0.054|TWO_SIDED|95.0|-0.03|3.25|||ANCOVA|ANCOVA of GAD7 post-intervention, with baseline as covariate, effect of group||||3.25|-0.03|0.054
74010384|NCT04272892|147571855|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.229|TWO_SIDED|95.0|-0.7|2.87|||ANCOVA|ANCOVA of GAD7 at 8 week follow up, with baseline as covariate, effect of group||||2.87|-.70|0.229
74010385|NCT04272892|147571856|SUPERIORITY||Mean Difference (Final Values)|-1.39||||0.502|TWO_SIDED|95.0|-5.51|2.73|||ANCOVA|ANCOVA of SIS index at post-intervention, with baseline as covariate, effect of group||||2.73|-5.51|0.502
74010386|NCT04272892|147571857|SUPERIORITY||Mean Difference (Final Values)|0.183||||0.924|TWO_SIDED|95.0|-3.63|4.0|||ANCOVA|ANCOVA of SIS index at 8 week follow up, with baseline as covariate, effect of group||||4.0|-3.63|0.924
74010387|NCT05318937|147571864|SUPERIORITY||Difference in LS Means|0.0|STANDARD_ERROR_OF_MEAN|2.07||0.9934|TWO_SIDED|95.0|-4.13|4.09||The p-value was obtained using a MMRM model which included treatment, visit, treatment-by-visit interaction as categorical covariates, and WAIS-IV at baseline as continuous covariates.|MMRM||Difference was calculated as SAGE-718 - placebo.|||4.09|-4.13|0.9934
74010388|NCT01877915|147571875|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.27|TWO_SIDED|95.0|0.84|1.05|||Log Rank|||Statistical Analysis 1||1.05|0.84|0.270
74010389|NCT01877915|147571881|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.951|TWO_SIDED|95.0|0.41|2.59|||Log Rank|||Statistical Analysis 1 (Fatal Bleeding)||2.59|0.41|0.951
74010390|NCT01877915|147571881|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.253|TWO_SIDED|95.0|0.33|1.34|||Log Rank|||Statistical Analysis 2 (Bleeding in Critical Space with Potential for Permanent Disability)||1.34|0.33|0.253
74010391|NCT02046096|147571887|OTHER||12-month rate (%)|97.8|||<|0.0001|TWO_SIDED|95.0|95.6|99.1||The threshold for statistical significance was p = 0.025|One-tailed Exact binomial test||The 95% confidence interval was computed using Exact method.|Null Hypothesis: The rate of technical placement success and 12-month freedom from new symptomatic PE while a filter is indwelling, π, does not meet the performance goal (90%).||99.1|95.6|<0.0001
74010392|NCT02046096|147571888|OTHER||Cumulative probability|81.5|STANDARD_ERROR_OF_MEAN|4.5||0.369|TWO_SIDED|95.0|72.6|90.4||the threshold for statistical significance is 0.025.|Z-statistic|The hypothesis is assessed using a Z-statistic. The Z-statistic is given by Z = (Ŝ(t) - 0.8) / SE where SE is the Standard Error|The estimate of the variance of the Kaplan-Meier estimate used the methods described by Peto et al.|"the null hypotheses is: H0: S(t) ≤ 80%(Performance Goal) where,~* t is time through 12 months~* S(t) is the true rate of freedom from major adverse events at time t."||90.4|72.6|0.369
74010393|NCT02046096|147571889|OTHER||12-month freedom from MAE rate (%)|86.7||||0.001|TWO_SIDED|95.0|82.5|90.2||The threshold for statistical significance was p = 0.025|One-tailed exact binomial test|||Null Hypothesis: The 12-month freedom from MAE, π, does not meet the performance goal (80%).||90.2|82.5|0.001
74010394|NCT05314517|147571921|OTHER||Stratified Common Risk Difference|14.1||||0.1244|TWO_SIDED|90.0|-1.0|29.2|||Cochran-Mantel-Haenszel|||||29.2|-1.0|0.1244
74010395|NCT04490018|147571953|NON_INFERIORITY|The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater than (\>) -10%.|Difference in Percentage|4.98|||||TWO_SIDED|95.0|0.06|10.36||||||Serogroup A||10.36|0.06|
74010396|NCT04490018|147571953|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|4.97|||||TWO_SIDED|95.0|1.58|9.5||||||Serogroup C||9.50|1.58|
74010397|NCT04490018|147571953|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|1.24|||||TWO_SIDED|95.0|-1.28|4.42||||||Serogroup W||4.42|-1.28|
74010398|NCT04490018|147571953|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|1.24|||||TWO_SIDED|95.0|-1.88|4.77||||||Serogroup Y||4.77|-1.88|
74041108|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.8363|TWO_SIDED|95.0|-1.3|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.1|-1.3|0.8363
74041109|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.2388|TWO_SIDED|95.0|-1.8|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.5|-1.8|0.2388
74041110|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.9435|TWO_SIDED|95.0|-1.5|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.4|-1.5|0.9435
74041111|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.4267|TWO_SIDED|95.0|-0.8|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.9|-0.8|0.4267
74041112|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.681|TWO_SIDED|95.0|-1.6|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.0|-1.6|0.6810
74041113|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.82||0.7673|TWO_SIDED|95.0|-1.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.9|-1.4|0.7673
73879332|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0144|TWO_SIDED|95.0|-0.91|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.10|-0.91|0.0144
73879333|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0013|TWO_SIDED|95.0|-1.06|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.26|-1.06|0.0013
73879334|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0596|TWO_SIDED|95.0|-0.8|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.02|-0.80|0.0596
74010399|NCT04714073|147571981|OTHER||Ratio of geometric means (%)|218.81|||||TWO_SIDED|90.0|194.06|246.72|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 18.1."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||246.72|194.06|
74010400|NCT04714073|147571982|OTHER||Ratio of geometric means (%)|156.29|||||TWO_SIDED|90.0|135.04|180.89|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 22.1."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||180.89|135.04|
74010401|NCT04714073|147571983|OTHER||Ratio of geometric means (%)|223.12|||||TWO_SIDED|90.0|198.61|250.66|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 17.5."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||250.66|198.61|
74010402|NCT00943579|147571984|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||Chi-square analyses were used to assess CGI-I scores. there were no transformations.||||>.05
74092814|NCT02504671|147737910|OTHER||Mean Difference (Net)|-4.17||||0.102|TWO_SIDED|95.0|-9.17|0.84||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||0.84|-9.17|0.102
74092815|NCT02504671|147737910|OTHER||Mean Difference (Net)|-3.47||||0.17|TWO_SIDED|95.0|-8.43|1.49||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||1.49|-8.43|0.170
73887964|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|204.4|||<|0.0001|TWO_SIDED|95.0|137.5|271.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||271.3|137.5|<0.0001
74010403|NCT01401842|147572003|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on lumbar extension muscular strength (Nm) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.001
74010404|NCT01401842|147572004|SUPERIORITY_OR_OTHER|||||||0.871|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.871
74010405|NCT01401842|147572005|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.021
74010406|NCT00282295|147572006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of -10%.|Difference|2.18|||||TWO_SIDED|95.0|0.79|4.17||||||The non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-diphtheria toxoid (anti-D) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.||4.17|0.79|
74010407|NCT00282295|147572006|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of -10%.|Difference|0.02|||||TWO_SIDED|95.0|-1.4|1.48||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared toBoostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-tetanus toxoid (anti-T) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.||1.48|-1.4|
74092816|NCT02504671|147737910|OTHER||Mean Difference (Net)|-5.2||||0.039|TWO_SIDED|95.0|-10.13|-0.27||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-0.27|-10.13|0.039
74092817|NCT02504671|147737910|OTHER||Mean Difference (Net)|-7.2||||0.012|TWO_SIDED|95.0|-12.82|-1.57||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-1.57|-12.82|0.012
74092818|NCT02504671|147737910|OTHER||Mean Difference (Net)|-6.73||||0.018|TWO_SIDED|95.0|-12.3|-1.16||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-1.16|-12.30|0.018
73879335|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.036|TWO_SIDED|95.0|-0.85|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.03|-0.85|0.0360
73879336|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0006|TWO_SIDED|95.0|-1.15|-0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.32|-1.15|0.0006
74092819|NCT02504671|147737910|OTHER||Mean Difference (Net)|-9.19||||0.001|TWO_SIDED|95.0|-14.73|-3.66||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-3.66|-14.73|0.001
74092820|NCT02504671|147737910|OTHER||Mean Difference (Net)|-5.48||||0.065|TWO_SIDED|95.0|-11.31|0.35||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||0.35|-11.31|0.065
74092821|NCT02504671|147737910|OTHER||Mean Difference (Net)|-5.85||||0.05|TWO_SIDED|95.0|-11.69|0.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-0.00|-11.69|0.050
74092822|NCT02504671|147737910|OTHER||Mean Difference (Final Values)|-6.63||||0.024|TWO_SIDED|95.0|-12.38|-0.87||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-0.87|-12.38|0.024
74092823|NCT02504671|147737910|OTHER||Mean Difference (Net)|-6.41||||0.051|TWO_SIDED|95.0|-12.84|0.02||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||0.02|-12.84|0.051
73879337|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.23|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.39|-1.23|0.0002
73879338|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3227|TWO_SIDED|95.0|-0.62|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.21|-0.62|0.3227
74092824|NCT02504671|147737910|OTHER||Mean Difference (Net)|-8.6||||0.008|TWO_SIDED|95.0|-14.97|-2.22||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-2.22|-14.97|0.008
74092825|NCT02504671|147737910|OTHER||Mean Difference (Net)|-8.74||||0.007|TWO_SIDED|95.0|-15.06|-2.43||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-2.43|-15.06|0.007
73879339|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.022|TWO_SIDED|95.0|-0.89|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.07|-0.89|0.0220
74092826|NCT02504671|147737910|OTHER||Mean Difference (Net)|-6.8||||0.071|TWO_SIDED|95.0|-14.19|0.58||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||0.58|-14.19|0.071
73879340|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.038|TWO_SIDED|95.0|-0.84|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.02|-0.84|0.0380
74092827|NCT02504671|147737910|OTHER||Mean Difference (Net)|-9.8||||0.009|TWO_SIDED|95.0|-17.17|-2.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-2.44|-17.17|0.009
74092828|NCT02504671|147737910|OTHER||Mean Difference (Net)|-13.88|||<|0.001|TWO_SIDED|95.0|-21.17|-6.59||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-6.59|-21.17|<0.001
74092829|NCT02504671|147737910|OTHER||Mean Difference (Net)|-1.68||||0.676|TWO_SIDED|95.0|-9.63|6.26||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||6.26|-9.63|0.676
74092830|NCT02504671|147737910|OTHER||Mean Difference (Net)|-6.33||||0.11|TWO_SIDED|95.0|-14.11|1.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||1.44|-14.11|0.110
74092831|NCT02504671|147737910|OTHER||Mean Difference (Net)|-6.44||||0.099|TWO_SIDED|95.0|-14.12|1.23||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||1.23|-14.12|0.099
73887965|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|160.5|||<|0.0001|TWO_SIDED|95.0|93.5|227.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.4|93.5|<0.0001
74092832|NCT02504671|147737910|OTHER||Mean Difference (Net)|1.04||||0.812|TWO_SIDED|95.0|-7.61|9.69||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||9.69|-7.61|0.812
74041114|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.483|TWO_SIDED|95.0|-1.9|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.9|-1.9|0.4830
74041115|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.2128|TWO_SIDED|95.0|-2.1|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.5|-2.1|0.2128
74041116|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.83||0.1756|TWO_SIDED|95.0|-2.8|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.5|-2.8|0.1756
74041117|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.72||0.4246|TWO_SIDED|95.0|-0.8|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||2.0|-0.8|0.4246
74041118|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.68||0.2873|TWO_SIDED|95.0|-2.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.6|-2.1|0.2873
74041119|NCT01617187|147634061|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.7308|TWO_SIDED|95.0|-1.9|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.4|-1.9|0.7308
74041120|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2116|TWO_SIDED|95.0|-0.2|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.0|-0.2|0.2116
74041121|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.31||0.9039|TWO_SIDED|95.0|-0.6|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.7|-0.6|0.9039
74041122|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.2959|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.4|-1.2|0.2959
74041123|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.5909|TWO_SIDED|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.6|-1.1|0.5909
74041124|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1489|TWO_SIDED|95.0|-1.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-1.4|0.1489
74041125|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.54||0.1|TWO_SIDED|95.0|-2.0|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.2|-2.0|0.1000
74041126|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.49||0.783|TWO_SIDED|95.0|-0.8|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.1|-0.8|0.7830
74041127|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47||0.2679|TWO_SIDED|95.0|-1.4|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.4|0.2679
74041128|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2321|TWO_SIDED|95.0|-1.9|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.5|-1.9|0.2321
74041129|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.56||0.7368|TWO_SIDED|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||0.9|-1.3|0.7368
74041130|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.4606|TWO_SIDED|95.0|-1.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.7|-1.4|0.4606
74041131|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.66||0.3241|TWO_SIDED|95.0|-2.0|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.7|-2.0|0.3241
74092833|NCT02504671|147737910|OTHER||Mean Difference (Net)|-5.39||||0.204|TWO_SIDED|95.0|-13.75|2.96||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||2.96|-13.75|0.204
74041132|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.57||0.986|TWO_SIDED|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.1|-1.1|0.9860
74041133|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.53||0.189|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.3|-1.8|0.1890
74041134|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.67||0.303|TWO_SIDED|95.0|-2.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.6|-2.0|0.3030
74041135|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.055|TWO_SIDED|95.0|-2.3|0.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.0|-2.3|0.0550
74041136|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.55||0.0415|TWO_SIDED|95.0|-2.2|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||-0.0|-2.2|0.0415
74041137|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.9|STANDARD_ERROR_OF_MEAN|0.69||0.0058|TWO_SIDED|95.0|-3.3|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||-0.6|-3.3|0.0058
74041138|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.62||0.0691|TWO_SIDED|95.0|-2.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||0.1|-2.3|0.0691
74041139|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|0.58||0.0063|TWO_SIDED|95.0|-2.7|-0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||-0.5|-2.7|0.0063
73879341|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0067|TWO_SIDED|95.0|-0.6|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.10|-0.60|0.0067
73879342|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1227|TWO_SIDED|95.0|-0.45|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.05|-0.45|0.1227
73879343|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0208|TWO_SIDED|95.0|-0.57|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.05|-0.57|0.0208
73879344|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.2396|TWO_SIDED|95.0|-0.41|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.10|-0.41|0.2396
73879345|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0022|TWO_SIDED|95.0|-0.67|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.15|-0.67|0.0022
73879346|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0479|TWO_SIDED|95.0|-0.53|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.00|-0.53|0.0479
73879347|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.4152|TWO_SIDED|95.0|-0.35|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.15|-0.35|0.4152
74092834|NCT02504671|147737910|OTHER||Mean Difference (Net)|-5.9||||0.157|TWO_SIDED|95.0|-14.09|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||2.30|-14.09|0.157
74092835|NCT02504671|147737910|OTHER||Mean Difference (Net)|-9.37||||0.088|TWO_SIDED|95.0|-20.15|1.42||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||1.42|-20.15|0.088
74092836|NCT02504671|147737910|OTHER||Mean Difference (Net)|-15.12||||0.004|TWO_SIDED|95.0|-25.4|-4.83||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-4.83|-25.40|0.004
74010408|NCT00282295|147572007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of 0.67|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertussis toxoid (anti-PT) geometric mean antibody concentrations (GMCs) one month after vaccination.||1.03|0.84|
73879348|NCT03192176|147297611|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0262|TWO_SIDED|95.0|-0.52|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.03|-0.52|0.0262
73879349|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.121|TWO_SIDED|95.0|-0.43|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.05|-0.43|0.1210
74092837|NCT02504671|147737910|OTHER||Mean Difference (Net)|-14.91||||0.004|TWO_SIDED|95.0|-25.01|-4.8||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-4.80|-25.01|0.004
74092838|NCT02504671|147737910|OTHER||Mean Difference (Net)|-3.89||||0.06|TWO_SIDED|95.0|-7.96|0.17||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.17|-7.96|0.060
74092839|NCT02504671|147737910|OTHER||Mean Difference (Net)|-7.39|||<|0.001|TWO_SIDED|95.0|-11.42|-3.36||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||-3.36|-11.42|<0.001
74092840|NCT02504671|147737910|OTHER||Mean Difference (Net)|-6.1||||0.016|TWO_SIDED|95.0|-11.06|-1.14||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-1.14|-11.06|0.016
73879350|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0369|TWO_SIDED|95.0|-0.52|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.02|-0.52|0.0369
73879351|NCT03192176|147297611|SUPERIORITY||LSMean differencce|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.5855|TWO_SIDED|95.0|-0.32|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.18|-0.32|0.5855
73879352|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0041|TWO_SIDED|95.0|-0.62|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.12|-0.62|0.0041
73879353|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.0614|TWO_SIDED|95.0|-0.5|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.01|-0.50|0.0614
73879354|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3391|TWO_SIDED|95.0|-0.36|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.12|-0.36|0.3391
74010409|NCT00282295|147572007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of 0.67|Adjusted GMC ratio|0.76|||||TWO_SIDED|95.0|0.69|0.84||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-filamentous hemagglutinin (anti-FHA) GMCs one month after vaccination.||0.84|0.69|
74010410|NCT00282295|147572007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of 0.67|Adjusted GMC ratio|0.63|||||TWO_SIDED|95.0|0.54|0.72||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertactin (anti-PRN) GMCs one month after vaccination.||0.72|0.54|
74010411|NCT00282295|147572008|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-4.38|||||TWO_SIDED|95.0|-9.91|1.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PT one month after vaccination.||1.15|-9.91|
73879355|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0515|TWO_SIDED|95.0|-0.49|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.00|-0.49|0.0515
73879356|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0667|TWO_SIDED|95.0|-0.47|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.02|-0.47|0.0667
73879357|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0047|TWO_SIDED|95.0|-0.63|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.12|-0.63|0.0047
73887966|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|133.0||||0.0001|TWO_SIDED|95.0|66.1|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.9|66.1|0.0001
74010412|NCT00282295|147572008|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-3.39|||||TWO_SIDED|95.0|-7.03|0.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to FHA one month after vaccination.||0.15|-7.03|
74041140|NCT01617187|147634062|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|0.71||0.0056|TWO_SIDED|95.0|-3.4|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||-0.6|-3.4|0.0056
74041141|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.7847|TWO_SIDED|95.0|-0.6|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.8|-0.6|0.7847
74041142|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.5859|TWO_SIDED|95.0|-0.5|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.8|-0.5|0.5859
74041143|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.6413|TWO_SIDED|95.0|-1.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.6|-1.0|0.6413
74041144|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.38||0.7307|TWO_SIDED|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.9|-0.6|0.7307
74041145|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.7176|TWO_SIDED|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.9|-0.6|0.7176
74092841|NCT02504671|147737910|OTHER||Mean Difference (Net)|-6.85||||0.007|TWO_SIDED|95.0|-11.78|-1.91||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-1.91|-11.78|0.007
74092842|NCT02504671|147737910|OTHER||Mean Difference (Net)|-7.92||||0.005|TWO_SIDED|95.0|-13.48|-2.37||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-2.37|-13.48|0.005
74092843|NCT02504671|147737910|OTHER||Mean Difference (Net)|-12.19|||<|0.001|TWO_SIDED|95.0|-17.74|-6.64||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-6.64|-17.74|<0.001
74092844|NCT02504671|147737910|OTHER||Mean Difference (Net)|-5.62||||0.059|TWO_SIDED|95.0|-11.45|0.21||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||0.21|-11.45|0.059
74092845|NCT02504671|147737910|OTHER||Mean Difference (Net)|-10.17|||<|0.001|TWO_SIDED|95.0|-15.97|-4.38||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-4.38|-15.97|<0.001
74092846|NCT02504671|147737910|OTHER||Mean Difference (Net)|-10.37||||0.002|TWO_SIDED|95.0|-16.75|-4.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-4.00|-16.75|0.002
74092847|NCT02504671|147737910|OTHER||Mean Difference (Net)|-13.79|||<|0.001|TWO_SIDED|95.0|-20.18|-7.41||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-7.41|-20.18|<0.001
74092848|NCT02504671|147737910|OTHER||Mean Difference (Net)|-9.67||||0.01|TWO_SIDED|95.0|-17.03|-2.31||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-2.31|-17.03|0.010
74092849|NCT02504671|147737910|OTHER||Mean Difference (Net)|-16.63|||<|0.001|TWO_SIDED|95.0|-23.97|-9.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-9.30|-23.97|<0.001
74092850|NCT02504671|147737910|OTHER||Mean Difference (Net)|-5.53||||0.165|TWO_SIDED|95.0|-13.37|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||2.30|-13.37|0.165
74092851|NCT02504671|147737910|OTHER||Mean Difference (Net)|-8.85||||0.022|TWO_SIDED|95.0|-16.39|-1.32||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||-1.32|-16.39|0.022
74092852|NCT02504671|147737910|OTHER||Mean Difference (Net)|-6.55||||0.127|TWO_SIDED|95.0|-14.99|1.89||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||1.89|-14.99|0.127
74092853|NCT02504671|147737910|OTHER||Mean Difference (Net)|-8.67||||0.034|TWO_SIDED|95.0|-16.67|-0.67||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||-0.67|-16.67|0.034
74092854|NCT02504671|147737910|OTHER||Mean Difference (Net)|-15.43||||0.004|TWO_SIDED|95.0|-25.78|-5.07||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-5.07|-25.78|0.004
74092855|NCT02504671|147737910|OTHER||Mean Difference (Net)|-19.88|||<|0.001|TWO_SIDED|95.0|-29.7|-10.06||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-10.06|-29.70|<0.001
74092856|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.01||||0.938|TWO_SIDED|95.0|-0.14|0.16||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.16|-0.14|0.938
74092857|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.0||||0.981|TWO_SIDED|95.0|-0.15|0.15||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.15|-0.15|0.981
74092858|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.01||||0.857|TWO_SIDED|95.0|-0.16|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.14|-0.16|0.857
74092859|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.05||||0.592|TWO_SIDED|95.0|-0.13|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.22|-0.13|0.592
74092860|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.01||||0.917|TWO_SIDED|95.0|-0.16|0.18||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.18|-0.16|0.917
74010413|NCT00282295|147572008|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-1.96|||||TWO_SIDED|95.0|-5.25|-1.25||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PRN one month after vaccination.||-1.25|-5.25|
74010414|NCT00282295|147572009|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|-0.21|||||TWO_SIDED|95.0|-4.85|4.43||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccinecompared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup A one month after vaccination.||4.43|-4.85|
74010415|NCT00282295|147572009|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.69|||||TWO_SIDED|95.0|-1.69|5.16||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup C one month after vaccination.||5.16|-1.69|
74010416|NCT00282295|147572009|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.82||||||95.0|-2.58|6.25||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup Y one month after vaccination.||6.25|-2.58|
74010417|NCT00282295|147572009|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|3.56|||||TWO_SIDED|95.0|0.96|6.45||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup W-135 one month after vaccination||6.45|0.96|
74010418|NCT00121108|147572025|SUPERIORITY||Relative risk|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.21|||Fisher Exact|||||0.21|0.08|<0.001
74010419|NCT01380379|147572036|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|Single group comparison pre-post change score, compared to a value of 0 (no change)||||||<.01
74010420|NCT01380379|147572037|SUPERIORITY_OR_OTHER||||||<|0.04|||||||t-test, 2 sided|||||||<.04
74010421|NCT01357577|147572041|OTHER|||||||0.48||||||P-Value show above is for post-assessment time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.||||||.48
74010422|NCT01357577|147572041|OTHER|||||||0.12||||||The p-value shown above is for the 6-month time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.||||||.12
74092861|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.05||||0.545|TWO_SIDED|95.0|-0.23|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.12|-0.23|0.545
74010423|NCT01357577|147572041|OTHER|||||||0.65||||||The p-value shown above refers to the treatment main effect.|Mixed Models Analysis|||||||.65
74010424|NCT01357577|147572041|OTHER|||||||0.072||||||The p-value shown above refers to the timepoint main effect.|Mixed Models Analysis|||||||.072
74010425|NCT01357577|147572041|OTHER|||||||0.005|||||||Mixed Models Analysis|The p-value shown above refers to the interaction.||||||.0050
74010426|NCT01357577|147572041|OTHER|||||||0.12|||||||Mixed Models Analysis|The p-value shown above refers to the site main effect.||||||.12
74010427|NCT01357577|147572042|OTHER|mixed-effects linear regression model adjusted for study site and the baseline value of the dependent variable.||||||0.12||||||Post-treatment P-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (Alcohol Use) score.||||||.12
74010428|NCT01357577|147572042|OTHER|||||||0.84||||||6-month P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.84
74010429|NCT01357577|147572042|OTHER|||||||0.26||||||treatment main effect|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.26
74010430|NCT01357577|147572042|OTHER|||||||0.14||||||Timepoint main effect P-value|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.14
74010431|NCT01357577|147572042|OTHER|||||||0.29||||||interaction|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.29
74010432|NCT01357577|147572042|OTHER|||||||0.16||||||Site main effect P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.16
74010433|NCT01357577|147572043|OTHER|||||||0.66||||||Post-treatment p-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (drug score).||||||.66
74010434|NCT01357577|147572043|OTHER|||||||0.53||||||6-month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.53
74010435|NCT01357577|147572043|OTHER|||||||0.86||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.86
74010436|NCT01357577|147572043|OTHER|||||||0.16||||||Timepoint main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.16
74010437|NCT01357577|147572043|OTHER|||||||0.47||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.47
74010438|NCT01357577|147572043|OTHER|||||||0.19||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.19
74092862|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.04||||0.707|TWO_SIDED|95.0|-0.16|0.24||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.24|-0.16|0.707
73879358|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.513|TWO_SIDED|95.0|-0.34|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.17|-0.34|0.5130
74010439|NCT01357577|147572044|OTHER|||||||0.18||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.18
74010440|NCT01357577|147572044|OTHER|||||||0.45||||||P-value at 6 months.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.45
74010441|NCT01357577|147572044|OTHER|||||||0.73||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.73
74010442|NCT01357577|147572044|OTHER|||||||0.63||||||Timepoint main effect P-Value|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.63
74010443|NCT01357577|147572044|OTHER|||||||0.024||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.024
74010444|NCT01357577|147572044|OTHER|||||||0.15||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.15
74010445|NCT01357577|147572045|OTHER|||||||0.48||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.48
74010446|NCT01357577|147572045|OTHER|||||||0.2||||||6-Month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.20
74010447|NCT01357577|147572045|OTHER|||||||0.26||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.26
73879359|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.75|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.23|-0.75|0.0002
74010448|NCT01357577|147572045|OTHER|||||||0.71||||||Timepoint main effect.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.71
74010449|NCT01357577|147572045|OTHER|||||||0.56||||||Interaction main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.56
74010450|NCT01357577|147572045|OTHER|||||||0.51||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.51
74010451|NCT01439282|147572088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.108||||||1-side P value was obtained|1-sample binomial test|||||||0.1080
74010452|NCT02232802|147572091|EQUIVALENCE|Following logarithmic transformation, Cmax values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.|least square mean difference ratio|99.42|||||TWO_SIDED|95.0|96.28|102.65|||||Geometric least square means are being compared.|Statistical comparison for Anti-FXa||102.65|96.28|
74010453|NCT02232802|147572091|EQUIVALENCE|Following logarithmic transformation, Cmax was subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean difference ratio|91.55|||||TWO_SIDED|95.0|86.65|96.73|||||Geometric least square means are being compared.|Statistical comparison on Anti-FIIa||96.73|86.65|
74010454|NCT02232802|147572092|EQUIVALENCE|Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean difference ratio|102.89|||||TWO_SIDED|95.0|100.67|105.15|||||Geometric least square means are being compared.|Anti-FXa statistical comparison||105.15|100.67|
74010455|NCT02232802|147572092|EQUIVALENCE|Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.|least square mean difference ratio|92.37|||||TWO_SIDED|95.0|87.72|97.25|||||Geometric least square means are being compared.|Anti-FIIa comparison||97.25|87.72|
74010456|NCT02232802|147572093|EQUIVALENCE|Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean ratio|104.26|||||TWO_SIDED|95.0|101.68|106.9|||||Geometric least square means are being compared.|Anti-FXA comparison||106.9|101.68|
74010457|NCT02232802|147572093|EQUIVALENCE|Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean ratio|90.44|||||TWO_SIDED|95.0|85.38|95.8|||||Geometric least square means are being compared.|Anti-FIIa comparison||95.8|85.38|
74010458|NCT02232802|147572094|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|least square mean ratio|0.0||||0.7642|TWO_SIDED|95.0|-0.5|0.5||An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Wilcoxon (Mann-Whitney)||Geometric least square means are being compared.|Anti-FXa comparison||0.5|-0.5|0.7642
74010459|NCT02232802|147572094|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|least square mean ratio|0.0||||0.9464|TWO_SIDED|95.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||Geometric least square means are being compared.|Anti-FIIa comparison||0.5|-0.5|0.9464
74092863|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.05||||0.603|TWO_SIDED|95.0|-0.15|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.26|-0.15|0.603
74092864|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.07||||0.473|TWO_SIDED|95.0|-0.27|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.13|-0.27|0.473
74092865|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.21|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.22|-0.21|0.987
74092866|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.04||||0.713|TWO_SIDED|95.0|-0.25|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.17|-0.25|0.713
74092867|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.1||||0.357|TWO_SIDED|95.0|-0.31|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.11|-0.31|0.357
74092868|NCT02504671|147737911|OTHER||Mean Difference (Final Values)|0.04||||0.748|TWO_SIDED|95.0|-0.19|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.26|-0.19|0.748
73887967|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|140.1|||<|0.0001|TWO_SIDED|95.0|73.1|207.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||207.0|73.1|<0.0001
74092869|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.11||||0.327|TWO_SIDED|95.0|-0.34|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.11|-0.34|0.327
74092870|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.1||||0.395|TWO_SIDED|95.0|-0.32|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.13|-0.32|0.395
74092871|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.05||||0.71|TWO_SIDED|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.21|-0.30|0.710
74092872|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.04||||0.74|TWO_SIDED|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.21|-0.30|0.740
74092873|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.11||||0.398|TWO_SIDED|95.0|-0.36|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.14|-0.36|0.398
74092874|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.16||||0.364|TWO_SIDED|95.0|-0.19|0.52||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.52|-0.19|0.364
74092875|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.12||||0.503|TWO_SIDED|95.0|-0.23|0.46||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.46|-0.23|0.503
74092876|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.08||||0.647|TWO_SIDED|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.26|-0.42|0.647
74092877|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.02||||0.91|TWO_SIDED|95.0|-0.37|0.33||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.33|-0.37|0.910
73879360|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0126|TWO_SIDED|95.0|-0.6|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.07|-0.60|0.0126
73879361|NCT03192176|147297611|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3507|TWO_SIDED|95.0|-0.36|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.13|-0.36|0.3507
73879362|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0098|TWO_SIDED|95.0|-0.6|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.08|-0.60|0.0098
73879363|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0048|TWO_SIDED|95.0|-0.63|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.11|-0.63|0.0048
73879364|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.28|-0.80|<0.0001
73879365|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.47|-1.00|<0.0001
73879366|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.6761|TWO_SIDED|95.0|-0.32|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.21|-0.32|0.6761
73879367|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0188|TWO_SIDED|95.0|-0.57|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.05|-0.57|0.0188
73879368|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0067|TWO_SIDED|95.0|-0.61|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.10|-0.61|0.0067
74010460|NCT02232802|147572100|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|103.94|||||TWO_SIDED|95.0|101.22|106.73||||||||106.73|101.22|
74010461|NCT02232802|147572101|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|Geometric least square mean ratio|108.59|||||TWO_SIDED|95.0|103.93|113.46||||||||113.46|103.93|
74010462|NCT02232802|147572102|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|Geometric least square mean ratio|102.76|||||TWO_SIDED|95.0|97.51|108.28||||||||108.28|97.51|
74010463|NCT02232802|147572103|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|114.91|||||TWO_SIDED|95.0|102.29|129.08||||||||129.08|102.29|
74010464|NCT02232802|147572104|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Median Difference (Final Values)|0.0|||=|0.8554|TWO_SIDED|95.0|-0.5|0.5|||ANOVA|||||0.5|-0.5|= 0.8554
73879369|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0335|TWO_SIDED|95.0|-0.68|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.03|-0.68|0.0335
73879370|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.91|-0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.25|-0.91|0.0007
74010465|NCT02232802|147572105|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|geometric least square mean ratio|100.86|||||TWO_SIDED|95.0|99.27|102.47||||||||102.47|99.27|
74010466|NCT02232802|147572106|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|geometric least square mean ratio|95.13|||||TWO_SIDED|95.0|85.7|105.6||||||||105.6|85.7|
74010467|NCT02232802|147572107|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Median Difference (Final Values)|0.0|||=|0.6857|TWO_SIDED|95.0|-0.25|0.5|||Wilcoxon (Mann-Whitney)||Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.|||0.5|-0.25|= 0.6857
74010468|NCT02232802|147572113|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|111.39|||||TWO_SIDED|95.0|105.89|117.17||||||||117.17|105.89|
74010469|NCT02232802|147572114|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|113.82|||||TWO_SIDED|95.0|107.47|120.53||||||||120.53|107.47|
73879371|NCT03192176|147297612|SUPERIORITY||LSMean differencce|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.48|-1.14|<0.0001
74010470|NCT02232802|147572119|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Median Difference (Final Values)|0.0|||=|0.9217|TWO_SIDED|95.0|-0.13|0.13|||Wilcoxon (Mann-Whitney)||Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.|||0.13|-0.13|= 0.9217
74010471|NCT00885703|147572136|SUPERIORITY|||||||0.0012||||||Analysis did not adjust for multiple comparisons.|Chi-squared|||Testing discontinuation of any dose Fluconazole (pooled by treatment and dose) versus discontinuation of Ampho B (pooled). The null hypothesis is the two treatments have the same proportion of discontinuation.||||0.0012
74010472|NCT00885703|147572137|SUPERIORITY|||||||0.012|||||||Fisher Exact|||Among 4 treatment arms, comparison of three categorical groups: (CM negative, CM negative after switching treatment, and CM Positive/Died/Lost to Follow-up) at week 10. The null hypothesis is the 4 treatment arms have no differences at week 10.||||0.012
74010473|NCT00885703|147572138|SUPERIORITY|||||||0.019|||||||Kruskal-Wallis|||Comparison of change in quantitative CSF culture among 4 treatment arms. The null hypothesis is the 4 treatment arms have the same change in CSF culture from entry to week 2.||||0.019
74010474|NCT00885703|147572139|SUPERIORITY|||||||0.0894||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1200mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.0894
74010475|NCT00885703|147572139|SUPERIORITY|||||||0.4828||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1600mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.4828
74010476|NCT00885703|147572139|SUPERIORITY|||||||0.1766||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 2000mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.1766
74010477|NCT04096274|147572163|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||.014
74041146|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.486|TWO_SIDED|95.0|-1.3|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.6|-1.3|0.4860
74041147|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.9321|TWO_SIDED|95.0|-0.8|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||0.8|-0.8|0.9321
74041148|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.39||0.7691|TWO_SIDED|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-0.7|0.7691
73879372|NCT03192176|147297612|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.41|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.74|-1.41|<0.0001
73879373|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3227|TWO_SIDED|95.0|-0.5|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.17|-0.50|0.3227
73879374|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0085|TWO_SIDED|95.0|-0.77|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.11|-0.77|0.0085
74010478|NCT04096274|147572164|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||||||.023
74010479|NCT04096274|147572165|SUPERIORITY|||||||0.188|||||||Mixed Models Analysis|||||||.188
74010480|NCT04096274|147572166|SUPERIORITY|||||||0.782|||||||Mixed Models Analysis|||||||.782
74010481|NCT02113436|147572187|SUPERIORITY_OR_OTHER||Difference in Least square means|-0.97||||0.206|TWO_SIDED|95.0|-2.47|0.54|||ANCOVA|||||0.54|-2.47|0.206
74010482|NCT02113436|147572188|SUPERIORITY_OR_OTHER||Difference in Least sqaure means|-0.49||||0.235|TWO_SIDED|95.0|-1.29|0.32|||ANCOVA|||||0.32|-1.29|0.235
74010483|NCT02113436|147572189|SUPERIORITY_OR_OTHER||Difference in Least-Sqaure means|-0.48||||0.236|TWO_SIDED|95.0|-1.27|0.31|||ANCOVA|||||0.31|-1.27|0.236
74010484|NCT02113436|147572190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.14|1.6||||||||1.60|0.14|
74010485|NCT02113436|147572191|SUPERIORITY_OR_OTHER||Difference in Least-Square Means|0.7||||0.041|TWO_SIDED|95.0|0.0|1.4|||ANCOVA|||||1.4|0.0|0.041
74010486|NCT02113436|147572192|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.06||||0.335|TWO_SIDED|95.0|-0.2|0.07|||ANCOVA|||||0.07|-0.20|0.335
74010487|NCT02113436|147572193|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.6||||0.389|TWO_SIDED|95.0|-3.3|8.6|||ANCOVA|||||8.6|-3.3|0.389
74010488|NCT01263483|147572195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.002|||||TWO_SIDED|95.0|-1.166|-0.838||||||||-0.838|-1.166|
74010489|NCT01263483|147572195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.947|||||TWO_SIDED|95.0|-1.097|-0.796||||||||-0.796|-1.097|
74010490|NCT01263483|147572196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176|||||TWO_SIDED|95.0|-0.229|-0.123||||||||-0.123|-0.229|
74010491|NCT01263483|147572196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.247|-0.133||||||||-0.133|-0.247|
74010492|NCT01263483|147572197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.421|||||TWO_SIDED|95.0|-0.507|-0.334||||||||-0.334|-0.507|
74010493|NCT01263483|147572197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.414|||||TWO_SIDED|95.0|-0.504|-0.324||||||||-0.324|-0.504|
74041149|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5||0.5694|TWO_SIDED|95.0|-1.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.7|-1.3|0.5694
73879375|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0002|TWO_SIDED|95.0|-0.95|-0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.30|-0.95|0.0002
74092878|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.08||||0.66|TWO_SIDED|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.26|-0.42|0.660
73879376|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0102|TWO_SIDED|95.0|-0.87|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.12|-0.87|0.0102
73879377|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.15|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.39|-1.15|<0.0001
73879378|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.29|-0.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.54|-1.29|<0.0001
74092879|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.16||||0.34|TWO_SIDED|95.0|-0.5|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.17|-0.50|0.340
74092880|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.02||||0.902|TWO_SIDED|95.0|-0.34|0.39||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.39|-0.34|0.902
74092881|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.07||||0.687|TWO_SIDED|95.0|-0.42|0.28||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.28|-0.42|0.687
74092882|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.09||||0.599|TWO_SIDED|95.0|-0.44|0.25||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.25|-0.44|0.599
74092883|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.04||||0.588|TWO_SIDED|95.0|-0.19|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.11|-0.19|0.588
73879379|NCT03192176|147297612|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.46|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.68|-1.46|<0.0001
73879380|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.074|TWO_SIDED|95.0|-0.73|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||0.03|-0.73|0.0740
73887968|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|219.5|||<|0.0001|TWO_SIDED|95.0|127.6|311.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||311.3|127.6|<0.0001
74092884|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.09||||0.259|TWO_SIDED|95.0|-0.23|0.06||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.06|-0.23|0.259
74092885|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.08||||0.358|TWO_SIDED|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.09|-0.26|0.358
74092886|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.09||||0.325|TWO_SIDED|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.09|-0.26|0.325
74092887|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.07||||0.473|TWO_SIDED|95.0|-0.28|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.13|-0.28|0.473
74092888|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.18||||0.085|TWO_SIDED|95.0|-0.38|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.02|-0.38|0.085
74092889|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.01||||0.897|TWO_SIDED|95.0|-0.2|0.23||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.23|-0.20|0.897
74092890|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.2||||0.065|TWO_SIDED|95.0|-0.42|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.01|-0.42|0.065
74092891|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.14||||0.238|TWO_SIDED|95.0|-0.36|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.09|-0.36|0.238
74092892|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.21||||0.071|TWO_SIDED|95.0|-0.44|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.02|-0.44|0.071
74010494|NCT01263483|147572198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.738|||||TWO_SIDED|95.0|-0.871|-0.605||||||||-0.605|-0.871|
74010495|NCT01263483|147572198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.749|||||TWO_SIDED|95.0|-0.875|-0.623||||||||-0.623|-0.875|
74010496|NCT01263483|147572199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.01|||||TWO_SIDED|95.0|-18.5|-5.52||||||||-5.52|-18.50|
74010497|NCT01263483|147572199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.33|||||TWO_SIDED|95.0|-21.93|-8.73||||||||-8.73|-21.93|
74010498|NCT01263483|147572200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65|||||TWO_SIDED|95.0|-23.02|-8.27||||||||-8.27|-23.02|
74010499|NCT01263483|147572200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.03|||||TWO_SIDED|95.0|-29.68|-14.38||||||||-14.38|-29.68|
74010500|NCT01263483|147572201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3|||||TWO_SIDED|95.0|-26.09|-10.5||||||||-10.50|-26.09|
74010501|NCT01263483|147572201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.34|||||TWO_SIDED|95.0|-27.34|-11.34||||||||-11.34|-27.34|
74010502|NCT01263483|147572202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.53|||||TWO_SIDED|95.0|-21.46|-5.6||||||||-5.60|-21.46|
74010503|NCT01263483|147572202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.97|||||TWO_SIDED|95.0|-21.53|-4.41||||||||-4.41|-21.53|
73887969|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|145.0||||0.0022|TWO_SIDED|95.0|53.2|236.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||236.8|53.2|0.0022
74010504|NCT01263483|147572203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.304|0.104||||||||0.104|-0.304|
74010505|NCT01263483|147572203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|||||TWO_SIDED|95.0|-0.239|0.167||||||||0.167|-0.239|
74010506|NCT01263483|147572204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|||||TWO_SIDED|95.0|-0.267|0.292||||||||0.292|-0.267|
74010507|NCT01263483|147572204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|||||TWO_SIDED|95.0|-0.264|0.196||||||||0.196|-0.264|
74010508|NCT01263483|147572205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|||||TWO_SIDED|95.0|-0.268|0.191||||||||0.191|-0.268|
74010509|NCT01263483|147572205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|||||TWO_SIDED|95.0|-0.261|0.115||||||||0.115|-0.261|
74010510|NCT01263483|147572206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|||||TWO_SIDED|95.0|-0.183|0.252||||||||0.252|-0.183|
74010511|NCT01263483|147572206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|||||TWO_SIDED|95.0|-0.124|0.288||||||||0.288|-0.124|
74010512|NCT01263483|147572207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.54|||||TWO_SIDED|95.0|-41.28|-21.8||||||||-21.80|-41.28|
74010513|NCT01263483|147572207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.73|||||TWO_SIDED|95.0|-44.88|-22.57||||||||-22.57|-44.88|
74010514|NCT01263483|147572208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.38|||||TWO_SIDED|95.0|-90.67|-50.09||||||||-50.09|-90.67|
74010515|NCT01263483|147572208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.49|||||TWO_SIDED|95.0|-93.1|-51.88||||||||-51.88|-93.10|
74010516|NCT01263483|147572209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.093|||||TWO_SIDED|95.0|2.229|11.958||||||||11.958|2.229|
74010517|NCT01263483|147572209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.967|||||TWO_SIDED|95.0|-0.521|8.455||||||||8.455|-0.521|
74010518|NCT01263483|147572210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-0.045|1.144||||||||1.144|-0.045|
74010519|NCT01263483|147572210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.428|||||TWO_SIDED|95.0|-0.233|1.09||||||||1.090|-0.233|
74010520|NCT01263483|147572211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.77|||||TWO_SIDED|95.0|-36.65|-0.9||||||||-0.90|-36.65|
74010521|NCT01263483|147572211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.04|||||TWO_SIDED|95.0|-37.82|-2.27||||||||-2.27|-37.82|
74010522|NCT01372384|147572228|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Partial Response at Visit 4 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed.||||0.045
74010523|NCT01372384|147572228|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Partial Response at Visit 6 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed||||1.000
74010524|NCT01372384|147572228|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Partial Response Vs Progression of disease at Visit 6 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed||||1.000
74010525|NCT01372384|147572228|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Progression of disease at Visit 6 (Two proportions for of Stable Disease Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Stable Disease Vs Progression of disease was analyzed||||1.000
74041150|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.45||0.5583|TWO_SIDED|95.0|-0.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.2|-0.6|0.5583
74041151|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.43||0.7307|TWO_SIDED|95.0|-0.7|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.0|-0.7|0.7307
74041152|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.54||0.1715|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.3|-1.8|0.1715
74041153|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.4219|TWO_SIDED|95.0|-0.6|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.5|-0.6|0.4219
73879381|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0024|TWO_SIDED|95.0|-0.97|-0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.21|-0.97|0.0024
73879382|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.17|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.41|-1.17|<0.0001
73879383|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1197|TWO_SIDED|95.0|-0.72|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.08|-0.72|0.1197
73879384|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0046|TWO_SIDED|95.0|-0.98|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.18|-0.98|0.0046
73879385|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.28|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.47|-1.28|<0.0001
74010526|NCT01372384|147572228|SUPERIORITY_OR_OTHER|||||||0.274|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Partial Response Vs Progression of disease at Visit 10 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed||||0.274
74010527|NCT00829179|147572240|SUPERIORITY_OR_OTHER||Difference in Mean|11.0|STANDARD_DEVIATION|13.3||0.005||95.0|||||Sign test|||||||0.005
74010528|NCT01299376|147572246|SUPERIORITY_OR_OTHER||Difference in Least-squares Means|-5.9|||<|0.001|TWO_SIDED|95.0|-7.5|-4.2|||Contrained Longitudinal Data Analysis|Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.||||-4.2|-7.5|<0.001
74092893|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.12||||0.34|TWO_SIDED|95.0|-0.38|0.13||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.13|-0.38|0.340
74010529|NCT01299376|147572257|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3|||<|0.001|TWO_SIDED|95.0|-12.8|-7.7||Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.|Constrained Longitudinal Data Analysis|||||-7.7|-12.8|<0.001
74010530|NCT00941668|147572307|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74010531|NCT00941668|147572308|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74010532|NCT04315181|147572322|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=6.89, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
74010533|NCT04315181|147572323|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=5.51, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
74010534|NCT04315181|147572324|SUPERIORITY|||||||0.138||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=1.61, df=8, 72||Trough scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||0.138
74010535|NCT04315181|147572325|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=8.15, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
74092894|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.24||||0.059|TWO_SIDED|95.0|-0.49|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.01|-0.49|0.059
74092895|NCT02504671|147737911|OTHER||Mean Difference (Net)|0.09||||0.607|TWO_SIDED|95.0|-0.26|0.44||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.44|-0.26|0.607
74092896|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.01||||0.959|TWO_SIDED|95.0|-0.34|0.32||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.32|-0.34|0.959
74092897|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.15||||0.401|TWO_SIDED|95.0|-0.49|0.2||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.20|-0.49|0.401
74092898|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.21||||0.207|TWO_SIDED|95.0|-0.54|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.12|-0.54|0.207
74092899|NCT02504671|147737911|OTHER||Mean Difference (Net)|-0.08||||0.637|TWO_SIDED|95.0|-0.44|0.27||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.27|-0.44|0.637
74092900|NCT02504671|147737911|OTHER||Mean Difference (Final Values)|-0.2||||0.251|TWO_SIDED|95.0|-0.53|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.14|-0.53|0.251
73879386|NCT03192176|147297612|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.51|-0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.69|-1.51|<0.0001
74092901|NCT02504671|147737912|OTHER||Mean Difference (Net)|-2.45||||0.511|TWO_SIDED|95.0|-9.81|4.9||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||4.90|-9.81|0.511
74092902|NCT02504671|147737912|OTHER||Mean Difference (Net)|-2.76||||0.461|TWO_SIDED|95.0|-10.13|4.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||4.60|-10.13|0.461
74092903|NCT02504671|147737912|OTHER||Mean Difference (Net)|-7.71||||0.039|TWO_SIDED|95.0|-15.03|-0.39||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||-0.39|-15.03|0.039
74092904|NCT02504671|147737912|OTHER||Mean Difference (Net)|-2.92||||0.469|TWO_SIDED|95.0|-10.86|5.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||5.01|-10.86|0.469
74092905|NCT02504671|147737912|OTHER||Mean Difference (Net)|-5.99||||0.133|TWO_SIDED|95.0|-13.82|1.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||1.85|-13.82|0.133
74092906|NCT02504671|147737912|OTHER||Mean Difference (Net)|-7.58||||0.057|TWO_SIDED|95.0|-15.4|0.23||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||0.23|-15.40|0.057
73887970|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|200.2|||<|0.0001|TWO_SIDED|95.0|108.4|292.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||292.0|108.4|<0.0001
74092907|NCT02504671|147737912|OTHER||Mean Difference (Net)|-3.03||||0.49|TWO_SIDED|95.0|-11.67|5.61||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||5.61|-11.67|0.490
74092908|NCT02504671|147737912|OTHER||Mean Difference (Net)|-9.38||||0.031|TWO_SIDED|95.0|-17.91|-0.86||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-0.86|-17.91|0.031
74092909|NCT02504671|147737912|OTHER||Mean Difference (Net)|-12.21||||0.005|TWO_SIDED|95.0|-20.67|-3.74||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-3.74|-20.67|0.005
74092910|NCT02504671|147737912|OTHER||Mean Difference (Net)|-4.49||||0.345|TWO_SIDED|95.0|-13.83|4.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||4.85|-13.83|0.345
74092911|NCT02504671|147737912|OTHER||Mean Difference (Net)|-8.02||||0.09|TWO_SIDED|95.0|-17.3|1.26||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||1.26|-17.30|0.090
74092912|NCT02504671|147737912|OTHER||Mean Difference (Net)|-8.36||||0.074|TWO_SIDED|95.0|-17.55|0.83||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||0.83|-17.55|0.074
74092913|NCT02504671|147737912|OTHER||Mean Difference (Net)|-5.61||||0.268|TWO_SIDED|95.0|-15.57|4.34||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||4.34|-15.57|0.268
74092914|NCT02504671|147737912|OTHER||Mean Difference (Net)|-14.57||||0.004|TWO_SIDED|95.0|-24.43|-4.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-4.70|-24.43|0.004
74092915|NCT02504671|147737912|OTHER||Mean Difference (Net)|-13.94||||0.005|TWO_SIDED|95.0|-23.72|-4.16||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-4.16|-23.72|0.005
74092916|NCT02504671|147737912|OTHER||Mean Difference (Net)|-7.02||||0.182|TWO_SIDED|95.0|-17.36|3.32||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||3.32|-17.36|0.182
74092917|NCT02504671|147737912|OTHER||Mean Difference (Net)|-14.15||||0.007|TWO_SIDED|95.0|-24.42|-3.87||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-3.87|-24.42|0.007
74092918|NCT02504671|147737912|OTHER||Mean Difference (Net)|-18.18|||<|0.001|TWO_SIDED|95.0|-28.35|-8.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-8.01|-28.35|<0.001
74092919|NCT02504671|147737912|OTHER||Mean Difference (Net)|-4.89||||0.527|TWO_SIDED|95.0|-20.15|10.36||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||10.36|-20.15|0.527
74092920|NCT02504671|147737912|OTHER||Mean Difference (Net)|-15.95||||0.034|TWO_SIDED|95.0|-30.72|-1.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||-1.19|-30.72|0.034
74092921|NCT02504671|147737912|OTHER||Mean Difference (Net)|-13.86||||0.062|TWO_SIDED|95.0|-28.42|0.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||0.70|-28.42|0.062
74092922|NCT02504671|147737912|OTHER||Mean Difference (Net)|-0.69||||0.924|TWO_SIDED|95.0|-14.85|13.47||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||13.47|-14.85|0.924
74092923|NCT02504671|147737912|OTHER||Mean Difference (Net)|-13.17||||0.058|TWO_SIDED|95.0|-26.82|0.48||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||0.48|-26.82|0.058
74092924|NCT02504671|147737912|OTHER||Mean Difference (Net)|-13.49||||0.049|TWO_SIDED|95.0|-26.91|-0.08||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.08|-26.91|0.049
74092925|NCT02504671|147737912|OTHER||Mean Difference (Net)|-6.38||||0.445|TWO_SIDED|95.0|-22.84|10.07||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||10.07|-22.84|0.445
74092926|NCT02504671|147737912|OTHER||Mean Difference (Net)|-10.14||||0.205|TWO_SIDED|95.0|-25.87|5.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||5.58|-25.87|0.205
74092927|NCT02504671|147737912|OTHER||Mean Difference (Net)|-12.07||||0.125|TWO_SIDED|95.0|-27.55|3.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||3.41|-27.55|0.125
74092928|NCT02504671|147737912|OTHER||Mean Difference (Net)|-4.93||||0.187|TWO_SIDED|95.0|-12.26|2.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||2.41|-12.26|0.187
74092929|NCT02504671|147737912|OTHER||Mean Difference (Net)|-5.63||||0.13|TWO_SIDED|95.0|-12.93|1.67||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||1.67|-12.93|0.130
74092930|NCT02504671|147737912|OTHER||Mean Difference (Net)|-7.85||||0.051|TWO_SIDED|95.0|-15.72|0.03||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||0.03|-15.72|0.051
74092931|NCT02504671|147737912|OTHER||Mean Difference (Net)|-10.44||||0.009|TWO_SIDED|95.0|-18.27|-2.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||-2.60|-18.27|0.009
74092932|NCT02504671|147737912|OTHER||Mean Difference (Net)|-7.94||||0.068|TWO_SIDED|95.0|-16.47|0.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||0.58|-16.47|0.068
74092933|NCT02504671|147737912|OTHER||Mean Difference (Net)|-13.96||||0.001|TWO_SIDED|95.0|-22.47|-5.44||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-5.44|-22.47|0.001
74092934|NCT02504671|147737912|OTHER||Mean Difference (Net)|-7.36||||0.118|TWO_SIDED|95.0|-16.62|1.89||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||1.89|-16.62|0.118
74092935|NCT02504671|147737912|OTHER||Mean Difference (Net)|-12.43||||0.009|TWO_SIDED|95.0|-21.68|-3.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||-3.19|-21.68|0.009
74092936|NCT02504671|147737912|OTHER||Mean Difference (Net)|-16.51||||0.001|TWO_SIDED|95.0|-26.38|-6.65||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-6.65|-26.38|0.001
74092937|NCT02504671|147737912|OTHER||Mean Difference (Net)|-20.39|||<|0.001|TWO_SIDED|95.0|-30.27|-10.52||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-10.52|-30.27|<0.001
74092938|NCT02504671|147737912|OTHER||Mean Difference (Net)|-12.0||||0.022|TWO_SIDED|95.0|-22.27|-1.73||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-1.73|-22.27|0.022
74092939|NCT02504671|147737912|OTHER||Mean Difference (Net)|-17.94|||<|0.001|TWO_SIDED|95.0|-28.18|-7.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-7.70|-28.18|<0.001
74092940|NCT02504671|147737912|OTHER||Mean Difference (Net)|-13.2||||0.084|TWO_SIDED|95.0|-28.18|1.79||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||1.79|-28.18|0.084
74092941|NCT02504671|147737912|OTHER||Mean Difference (Net)|-11.87||||0.099|TWO_SIDED|95.0|-26.02|2.27||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||2.27|-26.02|0.099
73879387|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0553|TWO_SIDED|95.0|-0.8|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.01|-0.80|0.0553
73879388|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0823|TWO_SIDED|95.0|-0.76|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.76|0.0823
73879389|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.006|TWO_SIDED|95.0|-0.96|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.96|0.0060
73879390|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0374|TWO_SIDED|95.0|-0.83|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.03|-0.83|0.0374
73879391|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.0042|TWO_SIDED|95.0|-1.0|-0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.19|-1.00|0.0042
74092942|NCT02504671|147737912|OTHER||Mean Difference (Net)|-13.91||||0.048|TWO_SIDED|95.0|-27.68|-0.14||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.14|-27.68|0.048
74092943|NCT02504671|147737912|OTHER||Mean Difference (Net)|-13.22||||0.048|TWO_SIDED|95.0|-26.32|-0.13||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.13|-26.32|0.048
74092944|NCT02504671|147737912|OTHER||Mean Difference (Net)|-13.23||||0.102|TWO_SIDED|95.0|-29.11|2.64||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||2.64|-29.11|0.102
74092945|NCT02504671|147737912|OTHER||Mean Difference (Net)|-16.7||||0.03|TWO_SIDED|95.0|-31.79|-1.62||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||-1.62|-31.79|0.030
73879392|NCT03192176|147297612|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.38|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.56|-1.38|<0.0001
73879393|NCT03192176|147297612|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.54|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.71|-1.54|<0.0001
74092946|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.6||||0.683|TWO_SIDED|95.0|-2.31|3.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||3.52|-2.31|0.683
73879394|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.071|TWO_SIDED|95.0|-0.79|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.03|-0.79|0.0710
73879395|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.016|TWO_SIDED|95.0|-0.91|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.09|-0.91|0.0160
74092947|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.19||||0.03|TWO_SIDED|95.0|0.31|6.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||6.07|0.31|0.030
74092948|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.61||||0.074|TWO_SIDED|95.0|-0.25|5.47||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||5.47|-0.25|0.074
74092949|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.46||||0.39|TWO_SIDED|95.0|-1.88|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||4.80|-1.88|0.390
74092950|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.42||||0.154|TWO_SIDED|95.0|-0.91|5.75||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||5.75|-0.91|0.154
74092951|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.73||||0.302|TWO_SIDED|95.0|-1.56|5.02||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||5.02|-1.56|0.302
74010536|NCT04315181|147572326|SUPERIORITY|||||||0.0002||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=4.58, df=8, 72||Trough scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||0.0002
74010537|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.48|||||TWO_SIDED|95.0|1.22|1.81|||||The analysis of covariance (ANCOVA) model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 1||1.81|1.22|
74010538|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.31|||||TWO_SIDED|95.0|1.12|1.54|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 3||1.54|1.12|
74010539|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.13|1.58|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 4||1.58|1.13|
74010540|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.08|1.71|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 5||1.71|1.08|
74010541|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.37|||||TWO_SIDED|95.0|1.12|1.69|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 6A||1.69|1.12|
74010542|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.41|||||TWO_SIDED|95.0|1.17|1.7|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 6B||1.70|1.17|
74010543|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.16|1.55|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 7F||1.55|1.16|
74010544|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.38|||||TWO_SIDED|95.0|1.17|1.64|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 8||1.64|1.17|
74041154|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.52||0.7437|TWO_SIDED|95.0|-0.9|1.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.2|-0.9|0.7437
74041155|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.65||0.311|TWO_SIDED|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.6|-1.9|0.3110
74041156|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.9805|TWO_SIDED|95.0|-1.0|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.0|-1.0|0.9805
74041157|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.8741|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.8|-1.0|0.8741
74041158|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.58||0.3288|TWO_SIDED|95.0|-1.7|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.6|-1.7|0.3288
74041159|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.56||0.9336|TWO_SIDED|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-1.0|0.9336
74041160|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1722|TWO_SIDED|95.0|-1.7|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-1.7|0.1722
74041161|NCT01617187|147634063|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.64||0.1909|TWO_SIDED|95.0|-2.1|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.4|-2.1|0.1909
74041162|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.9851|TWO_SIDED|95.0|-0.7|0.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.7|-0.7|0.9851
74041163|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.36||0.4912|TWO_SIDED|95.0|-0.9|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.5|-0.9|0.4912
74041164|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8559|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.8|-1.0|0.8559
74041165|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.41||0.5635|TWO_SIDED|95.0|-0.6|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.1|-0.6|0.5635
73879396|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0003|TWO_SIDED|95.0|-1.15|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.34|-1.15|0.0003
73879397|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1013|TWO_SIDED|95.0|-0.76|0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.07|-0.76|0.1013
73879398|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0011|TWO_SIDED|95.0|-1.11|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.28|-1.11|0.0011
74010545|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.24|||||TWO_SIDED|95.0|1.05|1.47|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 9V||1.47|1.05|
74010546|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.22|||||TWO_SIDED|95.0|1.03|1.44|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 10A||1.44|1.03|
74010547|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.18|||||TWO_SIDED|95.0|0.98|1.42|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 11A||1.42|0.98|
74010548|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.2|||||TWO_SIDED|95.0|0.99|1.46|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 12F||1.46|0.99|
74010549|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.42|||||TWO_SIDED|95.0|1.21|1.67|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 14||1.67|1.21|
74010550|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.46|||||TWO_SIDED|95.0|1.22|1.76|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 15B||1.76|1.22|
74041166|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.2321|TWO_SIDED|95.0|-1.3|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.3|-1.3|0.2321
74041167|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.52||0.8867|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.9|-1.1|0.8867
74041168|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1499|TWO_SIDED|95.0|-0.2|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.4|-0.2|0.1499
74092952|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.69||||0.521|TWO_SIDED|95.0|-3.5|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.88|-3.50|0.521
74092953|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.28||||0.606|TWO_SIDED|95.0|-3.63|6.2||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.20|-3.63|0.606
74010551|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.29|||||TWO_SIDED|95.0|1.07|1.55|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 18C||1.55|1.07|
74010552|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 19A||1.61|1.20|
74041169|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.286|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.2|0.2860
74041170|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.8978|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.9|-1.1|0.8978
74041171|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.44||0.0283|TWO_SIDED|95.0|0.1|1.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.8|0.1|0.0283
73879399|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.36|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.53|-1.36|<0.0001
73879400|NCT03192176|147297612|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.57|-0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.72|-1.57|<0.0001
73879401|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0476|TWO_SIDED|95.0|-0.85|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.00|-0.85|0.0476
73879402|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.022|TWO_SIDED|95.0|-0.9|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.07|-0.90|0.0220
73879403|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0019|TWO_SIDED|95.0|-1.07|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.24|-1.07|0.0019
73879404|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1457|TWO_SIDED|95.0|-0.74|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.11|-0.74|0.1457
73879405|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0284|TWO_SIDED|95.0|-0.91|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.05|-0.91|0.0284
73879406|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0002|TWO_SIDED|95.0|-1.26|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.39|-1.26|0.0002
73879407|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.36|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.48|-1.36|<0.0001
73879408|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.4223|TWO_SIDED|95.0|-0.61|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.26|-0.61|0.4223
73879409|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0442|TWO_SIDED|95.0|-0.87|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.01|-0.87|0.0442
73879410|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.0071|TWO_SIDED|95.0|-1.02|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.16|-1.02|0.0071
74010553|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.33|||||TWO_SIDED|95.0|1.12|1.57|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 19F||1.57|1.12|
74010554|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.12|1.6|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 22F||1.60|1.12|
74010555|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.09|1.71|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 23F||1.71|1.09|
74041172|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.41||0.8667|TWO_SIDED|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-0.7|0.8667
74041173|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.52||0.5044|TWO_SIDED|95.0|-0.7|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.4|-0.7|0.5044
74041174|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.4|STANDARD_ERROR_OF_MEAN|0.49||0.004|TWO_SIDED|95.0|0.5|2.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.4|0.5|0.0040
74041175|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.46||0.633|TWO_SIDED|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.1|-0.7|0.6330
73879411|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0823|TWO_SIDED|95.0|-0.8|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.05|-0.80|0.0823
73879412|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0336|TWO_SIDED|95.0|-0.89|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.04|-0.89|0.0336
73879413|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.32|-0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.46|-1.32|<0.0001
73879414|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.47|-1.34|<0.0001
73879415|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.4819|TWO_SIDED|95.0|-0.59|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.28|-0.59|0.4819
73879416|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0371|TWO_SIDED|95.0|-0.88|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.03|-0.88|0.0371
73879417|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0121|TWO_SIDED|95.0|-0.97|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.12|-0.97|0.0121
73879418|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0281|TWO_SIDED|95.0|-0.89|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.05|-0.89|0.0281
73879419|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0436|TWO_SIDED|95.0|-0.86|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.01|-0.86|0.0436
73879420|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.49|-1.34|<0.0001
74041176|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.57||0.2981|TWO_SIDED|95.0|-0.5|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.7|-0.5|0.2981
73879421|NCT03192176|147297612|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.60|-1.47|<0.0001
73879422|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1488|TWO_SIDED|95.0|-0.75|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||0.11|-0.75|0.1488
73879423|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0251|TWO_SIDED|95.0|-0.91|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.06|-0.91|0.0251
73879424|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.0027|TWO_SIDED|95.0|-1.08|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.23|-1.08|0.0027
73879425|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1053|TWO_SIDED|95.0|-0.77|0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.07|-0.77|0.1053
74092954|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.46||||0.32|TWO_SIDED|95.0|-2.41|7.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||7.32|-2.41|0.320
74092955|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.5||||0.811|TWO_SIDED|95.0|-4.65|3.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||3.64|-4.65|0.811
74092956|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.45||||0.83|TWO_SIDED|95.0|-3.65|4.55||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||4.55|-3.65|0.830
74092957|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.54||||0.795|TWO_SIDED|95.0|-4.61|3.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||3.54|-4.61|0.795
74092958|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.32||||0.548|TWO_SIDED|95.0|-3.0|5.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.64|-3.00|0.548
74092959|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.46||||0.505|TWO_SIDED|95.0|-2.85|5.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.77|-2.85|0.505
73879426|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0304|TWO_SIDED|95.0|-0.9|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.04|-0.90|0.0304
74092960|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.12||||0.605|TWO_SIDED|95.0|-3.15|5.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.39|-3.15|0.605
74092961|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.43||||0.895|TWO_SIDED|95.0|-6.03|6.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||6.90|-6.03|0.895
74092962|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.29||||0.461|TWO_SIDED|95.0|-3.84|8.42||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||8.42|-3.84|0.461
74092963|NCT02504671|147737913|OTHER||Mean Difference (Net)|-1.05||||0.732|TWO_SIDED|95.0|-7.1|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||4.99|-7.10|0.732
74092964|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.11||||0.941|TWO_SIDED|95.0|-3.11|2.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||2.88|-3.11|0.941
74092965|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.73||||0.013|TWO_SIDED|95.0|0.78|6.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||6.67|0.78|0.013
74092966|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.92||||0.051|TWO_SIDED|95.0|-0.01|5.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||5.84|-0.01|0.051
74092967|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.53||||0.403|TWO_SIDED|95.0|-2.07|5.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||5.12|-2.07|0.403
74092968|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.82||||0.122|TWO_SIDED|95.0|-0.76|6.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||6.40|-0.76|0.122
74092969|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.08||||0.247|TWO_SIDED|95.0|-1.45|5.62||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||5.62|-1.45|0.247
74092970|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.85||||0.384|TWO_SIDED|95.0|-3.61|9.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||9.32|-3.61|0.384
74092971|NCT02504671|147737913|OTHER||Mean Difference (Net)|5.05||||0.105|TWO_SIDED|95.0|-1.07|11.16||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||11.16|-1.07|0.105
74092972|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.21||||0.29|TWO_SIDED|95.0|-2.76|9.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||9.17|-2.76|0.290
73887971|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|164.3||||0.0005|TWO_SIDED|95.0|72.4|256.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||256.1|72.4|0.0005
74092973|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.51||||0.738|TWO_SIDED|95.0|-3.52|2.5||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||2.50|-3.52|0.738
74092974|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.99||||0.513|TWO_SIDED|95.0|-1.99|3.97||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||3.97|-1.99|0.513
74092975|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.12||||0.934|TWO_SIDED|95.0|-2.83|3.08||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||3.08|-2.83|0.934
74010556|NCT05879107|147572333|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.4|||||TWO_SIDED|95.0|1.2|1.64|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 33F||1.64|1.20|
74010557|NCT05879107|147572334|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-A neutralizing titer was \<=1.5.|GMT ratio|1.06|||||TWO_SIDED|95.0|0.94|1.2|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|RSV-A||1.20|0.94|
74010558|NCT05879107|147572335|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-B neutralizing titer was \<=1.5.|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|RSV-B||1.13|0.89|
74010559|NCT03437564|147572349|EQUIVALENCE|The difference in the least square (LS) means between the formulations (dosing of one Vortioxetine 20 mg tablet - dosing of two Vortioxetine 10 mg tablets) and the two-sided 90% confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.996|||||TWO_SIDED|90.0|0.967|1.026|||ANOVA|||||1.026|0.967|
74010560|NCT03437564|147572350|EQUIVALENCE|The difference in the LS means between the formulations (dosing of one vortioxetine 20 mg tablet - dosing of two vortioxetine 10 mg tablets) and the two-sided 90% CI were provided using a crossover ANOVA model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.972|||||TWO_SIDED|90.0|0.937|1.008|||ANOVA|||||1.008|0.937|
74010561|NCT00916149|147572361|OTHER||||||>|0.05||||||For each group (levetiracetam and no treatment), the change in IEDs/hour from pre to post-intervention: p \>0.05. The a priori threshold for statistical significance was p=0.05.|Wilcoxon Signed Ranks Test|||Change in frequency of IEDs/per hour was assessed for each group (levetiracetam and no treatment)||||>0.05
74010562|NCT00916149|147572362|OTHER|||||||0.005|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the no treatment group.||||0.005
74010563|NCT00916149|147572362|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the levetiracetam group.||||>0.05
74010564|NCT00916149|147572363|OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the no treatment group.||||0.016
74010565|NCT00916149|147572363|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the levetiracetam treatment group.||||>0.05
74041177|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6556|TWO_SIDED|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.1|-0.7|0.6556
74041178|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.2889|TWO_SIDED|95.0|-1.3|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.4|-1.3|0.2889
74041179|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.53||0.9399|TWO_SIDED|95.0|-1.1|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||1.0|-1.1|0.9399
74041180|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.54||0.8955|TWO_SIDED|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-1.0|0.8955
74041181|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.3681|TWO_SIDED|95.0|-1.5|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.5|-1.5|0.3681
74041182|NCT01617187|147634064|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.62||0.8215|TWO_SIDED|95.0|-1.4|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.1|-1.4|0.8215
74041183|NCT00595868|147634096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.06|TWO_SIDED|95.0|1.0|2.9|||Chi-squared|||||2.9|1.0|0.06
74010566|NCT00916149|147572364|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the no treatment group.||||>0.05
74010567|NCT00916149|147572364|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the levetiracetam treatment group.||||>0.05
74010568|NCT00916149|147572365|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the no treatment group.||||>0.05
74041184|NCT00595868|147634097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.1|TWO_SIDED|95.0|0.9|5.2|||Chi-squared|||||5.2|0.9|0.10
74041185|NCT04268303|147634102|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74041186|NCT04268303|147634102|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74041187|NCT04268303|147634103|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
74041188|NCT04268303|147634103|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
74041189|NCT04268303|147634103|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
74092976|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.63||||0.687|TWO_SIDED|95.0|-2.43|3.68||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||3.68|-2.43|0.687
74092977|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.85||||0.233|TWO_SIDED|95.0|-1.2|4.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||4.91|-1.20|0.233
74092978|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.57||||0.708|TWO_SIDED|95.0|-2.44|3.59||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||3.59|-2.44|0.708
74010569|NCT00916149|147572365|OTHER|||||||0.045|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the levetiracetam treatment group.||||0.045
74010570|NCT00916149|147572366|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the no treatment group.||||>0.05
74010571|NCT00916149|147572366|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the levetiracetam treatment group.||||>0.05
74010572|NCT00916149|147572367|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the no treatment group||||>0.05
74010573|NCT00916149|147572367|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the levetiracetam treatment group||||>0.05
74010574|NCT00916149|147572368|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the no treatment group||||>0.05
74010575|NCT00916149|147572368|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the levetiracetam treatment group||||>0.05
74010576|NCT00916149|147572369|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the QOLIE score from pre to post time points in the levetiracetam treatment group||||>0.05
74010577|NCT00916149|147572370|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the no treatment group||||>0.05
74010578|NCT00916149|147572370|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the levetiracetam treatment group||||>0.05
74010579|NCT00916149|147572371|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the no treatment group||||>0.05
74010580|NCT00916149|147572371|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the levetiracetam treatment group||||>0.05
74010581|NCT00916149|147572372|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the no treatment group||||>0.05
74010582|NCT00916149|147572372|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the levetiracetam treatment group||||>0.05
74010583|NCT00916149|147572373|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the no treatment group||||>0.05
74010584|NCT00916149|147572373|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the levetiracetam treatment group||||>0.05
74010585|NCT00916149|147572374|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the no treatment group||||>0.05
74010586|NCT00916149|147572374|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the levetiracetam treatment group||||>0.05
74010587|NCT00916149|147572375|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the no treatment group||||>0.05
74010588|NCT00916149|147572375|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the levetiracetam treatment group||||>0.05
74010589|NCT00916149|147572376|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the no treatment group||||>0.05
74010590|NCT00916149|147572376|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the levetiracetam treatment group||||>0.05
74010591|NCT00916149|147572377|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the no treatment group||||>0.05
74010592|NCT00916149|147572377|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the levetiracetam treatment group||||>0.05
74010593|NCT00916149|147572378|OTHER|||||||0.014|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the no treatment group||||0.014
74010594|NCT00916149|147572378|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the levetiracetam treatment group||||>0.05
74010595|NCT00916149|147572379|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the no treatment group||||>0.05
74010596|NCT00916149|147572379|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
74010597|NCT00916149|147572380|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the no treatment group||||>0.05
74010598|NCT00916149|147572380|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the levetiracetam treatment group||||>0.05
74010599|NCT00916149|147572381|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Accuracy score from pre to post time points in the no treatment group||||>0.05
74010600|NCT00916149|147572382|OTHER|||||||0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Reaction Time score from pre to post time points in the no treatment group||||0.05
74010601|NCT00916149|147572383|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the no treatment group||||>0.05
74010602|NCT00916149|147572383|OTHER|||||||0.039|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group||||0.039
74010603|NCT00916149|147572384|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the no treatment group||||>0.05
74010604|NCT00916149|147572384|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
74010605|NCT00916149|147572385|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the no treatment group||||>0.05
74010606|NCT00916149|147572385|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
74010607|NCT00916149|147572386|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the no treatment group||||>0.05
74010608|NCT00916149|147572386|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
74010609|NCT00916149|147572387|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the no treatment group||||>0.05
74010610|NCT00916149|147572387|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
74010611|NCT00916149|147572388|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the no treatment group||||>0.05
74010612|NCT00916149|147572388|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
74010613|NCT00916149|147572389|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the no treatment group||||>0.05
74010614|NCT00916149|147572389|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
74010615|NCT00916149|147572390|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the no treatment group||||>0.05
74010616|NCT00916149|147572390|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
74010617|NCT00916149|147572391|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the no treatment group||||>0.05
74010618|NCT00916149|147572391|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the levetiracetam treatment group||||>0.05
74010619|NCT00916149|147572392|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the no treatment group||||>0.05
74010620|NCT00916149|147572392|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the levetiracetam treatment group||||>0.05
74010621|NCT00942175|147572402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|90.0|0.6106|0.8026|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.8026|0.6106|
74010622|NCT00942175|147572402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.734|||||TWO_SIDED|90.0|0.6516|0.8269|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.8269|0.6516|
74010623|NCT00942175|147572402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5564|||||TWO_SIDED|90.0|0.4877|0.6347|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.6347|0.4877|
74010624|NCT00942175|147572402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6783|||||TWO_SIDED|90.0|0.5063|0.9087|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9087|0.5063|
74010625|NCT00942175|147572403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8573|||||TWO_SIDED|90.0|0.802|0.9165|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9165|0.8020|
74041190|NCT04268303|147634103|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
74041191|NCT04268303|147634103|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
74041192|NCT04268303|147634103|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
74041193|NCT04268303|147634103|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 30 minutes post-dose||||<0.0001
74092979|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.29||||0.25|TWO_SIDED|95.0|-2.34|8.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||8.93|-2.34|0.250
74092980|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.76||||0.307|TWO_SIDED|95.0|-2.57|8.09||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||8.09|-2.57|0.307
74092981|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.53||||0.345|TWO_SIDED|95.0|-2.74|7.79||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||7.79|-2.74|0.345
74092982|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.16||||0.95|TWO_SIDED|95.0|-0.19|0.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||0.52|-0.19|0.950
74092983|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.88||||0.664|TWO_SIDED|95.0|-3.11|4.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||4.87|-3.11|0.664
74092984|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.01||||0.994|TWO_SIDED|95.0|-3.99|3.96||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||3.96|-3.99|0.994
74092985|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.6||||0.25|TWO_SIDED|95.0|-1.84|7.03||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||7.03|-1.84|0.250
74092986|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.21||||0.154|TWO_SIDED|95.0|-1.22|7.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||7.64|-1.22|0.154
74092987|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.5||||0.262|TWO_SIDED|95.0|-1.88|6.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||6.89|-1.88|0.262
74092988|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.32||||0.693|TWO_SIDED|95.0|-5.28|7.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||7.93|-5.28|0.693
74092989|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.28||||0.302|TWO_SIDED|95.0|-2.98|9.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||9.54|-2.98|0.302
74092990|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.61||||0.844|TWO_SIDED|95.0|-5.54|6.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||6.77|-5.54|0.844
74092991|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.66||||0.698|TWO_SIDED|95.0|-2.71|4.04||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||4.04|-2.71|0.698
74092992|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.38||||0.159|TWO_SIDED|95.0|-0.94|5.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||5.70|-0.94|0.159
74092993|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.53||||0.36|TWO_SIDED|95.0|-1.76|4.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||4.83|-1.76|0.360
74092994|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.82||||0.151|TWO_SIDED|95.0|-1.04|6.69||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.69|-1.04|0.151
74092995|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.01||||0.124|TWO_SIDED|95.0|-0.83|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.86|-0.83|0.124
74092996|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.0||||0.12|TWO_SIDED|95.0|-0.79|6.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.80|-0.79|0.120
74092997|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.64||||0.814|TWO_SIDED|95.0|-5.98|4.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||4.70|-5.98|0.814
74092998|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.41||||0.873|TWO_SIDED|95.0|-5.49|4.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||4.67|-5.49|0.873
74092999|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.23||||0.928|TWO_SIDED|95.0|-4.8|5.26||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||5.26|-4.80|0.928
74041194|NCT04268303|147634103|SUPERIORITY|||||||0.0075|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 30 minutes post-dose||||0.0075
74041195|NCT04268303|147634103|SUPERIORITY|||||||0.0032|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 20 minutes post-dose||||0.0032
74041196|NCT04268303|147634103|SUPERIORITY|||||||0.4097|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 20 minutes post-dose||||0.4097
74041197|NCT04268303|147634103|SUPERIORITY|||||||0.0457|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 10 minutes post-dose||||0.0457
74093000|NCT02504671|147737913|OTHER||Mean Difference (Net)|-1.29||||0.541|TWO_SIDED|95.0|-5.44|2.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||2.86|-5.44|0.541
74093001|NCT02504671|147737913|OTHER||Mean Difference (Net)|-1.29||||0.535|TWO_SIDED|95.0|-5.39|2.81||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||2.81|-5.39|0.535
74093002|NCT02504671|147737913|OTHER||Mean Difference (Net)|-1.03||||0.62|TWO_SIDED|95.0|-5.1|3.05||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||3.05|-5.10|0.620
74093003|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.34||||0.881|TWO_SIDED|95.0|-4.08|4.76||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional|||4.76|-4.08|0.881
74093004|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.66||||0.767|TWO_SIDED|95.0|-3.74|5.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,Role Emotional|||5.07|-3.74|0.767
74093005|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.24||||0.913|TWO_SIDED|95.0|-4.12|4.61||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional|||4.61|-4.12|0.913
74041198|NCT04268303|147634103|SUPERIORITY|||||||0.972|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 10 minutes post-dose||||0.9720
74041199|NCT00223652|147634123|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||=.001
74041200|NCT00223652|147634123|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
74041201|NCT00223652|147634123|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.95
74041202|NCT00223652|147634124|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Mixed Models Analysis|||||||>0.37
74041203|NCT00223652|147634125|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<.0001
74041204|NCT00223652|147634125|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Mixed Models Analysis|||||||0.61
74041205|NCT00223652|147634125|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.20
74041206|NCT00223652|147634126|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Generalized estimating equations models|||||||<0.0001
74041207|NCT00223652|147634126|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Generalized estimating equations models|||||||0.12
74041208|NCT00223652|147634126|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Generalized estimating equations models|||||||0.86
74041209|NCT00223652|147634127|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Mixed Models Analysis|||||||>0.37
74041210|NCT00223652|147634128|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Generalized estimating equations models|||||||>0.37
74041211|NCT01779648|147634154|SUPERIORITY_OR_OTHER|||||||0.785||95.0|||||Chi-squared|||||||0.785
74041212|NCT01779648|147634155|SUPERIORITY_OR_OTHER|||||||0.195||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.195
74041213|NCT01779648|147634156|SUPERIORITY_OR_OTHER|||||||0.722||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.722
74041214|NCT01779648|147634157|SUPERIORITY_OR_OTHER|||||||0.158||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.158
74041215|NCT01779648|147634158|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.301
74041216|NCT01779648|147634159|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline TVF (total volume flow) are controlled as fixed-effects parameters.||||||<0.001
74041217|NCT01779648|147634160|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline PVF (peak volume flow) are controlled as fixed-effects parameters.||||||<0.001
74041218|NCT01779648|147634161|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline PV (peak velocity)are controlled as fixed-effects parameters.||||||0.929
74041219|NCT01779648|147634163|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline peak volume flow are controlled as fixed-effects parameters.||||||0.008
74041220|NCT01779648|147634164|SUPERIORITY_OR_OTHER|||||||0.132||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline total volume flow are controlled as fixed-effects parameters.||||||0.132
74041221|NCT03657810|147634180|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0||||Type III P-Value are from the likelihood ration test from the logistic regression model with factors of treatment, gender, and investigator.|Regression, Logistic|||||||<0.001
74010626|NCT00942175|147572403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9103|||||TWO_SIDED|90.0|0.8567|0.9672|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9672|0.8567|
74010627|NCT00942175|147572403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6943|||||TWO_SIDED|90.0|0.6438|0.7487|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.7487|0.6438|
74010628|NCT00942175|147572403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8389|||||TWO_SIDED|90.0|0.644|1.0928|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||1.0928|0.6440|
74010629|NCT00942175|147572404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1016|||||TWO_SIDED|90.0|0.0348|8.1684|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||8.1684|0.0348|
74010630|NCT00942175|147572404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0474|||||TWO_SIDED|90.0|-0.8555|4.9503|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||4.9503|-0.8555|
74010631|NCT00942175|147572404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0407|||||TWO_SIDED|90.0|6.5219|15.5595|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||15.5595|6.5219|
74010632|NCT00942175|147572404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4437|||||TWO_SIDED|90.0|7.1791|15.7083|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||15.7083|7.1791|
74010633|NCT00942175|147572405|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.035
74010634|NCT00942175|147572405|SUPERIORITY_OR_OTHER|||||||0.445||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.445
74010635|NCT00942175|147572405|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
74010636|NCT00942175|147572405|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
74010637|NCT00942175|147572406|SUPERIORITY_OR_OTHER|||||||0.004||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.004
74010638|NCT00942175|147572406|SUPERIORITY_OR_OTHER|||||||0.148||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.148
74010639|NCT00942175|147572406|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
74010640|NCT00942175|147572406|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<.0001
74010641|NCT00545064|147572416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|20.2||0.001||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 score = 7"||7.0|-0.6|0.001
74010642|NCT00545064|147572416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|20.2||0.097||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 = 0"||7.0|-0.6|0.097
74010643|NCT00545064|147572419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|STANDARD_DEVIATION|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = -4"||-10.7|-12.3|<0.001
74010644|NCT00545064|147572419|SUPERIORITY_OR_OTHER||Median Difference (Net)|-11.5|STANDARD_DEVIATION|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = 0"||-10.7|-12.3|<0.001
74010645|NCT01940471|147572421|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample sizes of 288 and 576 participants in the TDF and TAF groups, respectively, were planned to give 84% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size based on the assumption that the expected difference (TAF - TDF) in the proportion of participants with HBV DNA \< 29 IU/mL was 0 and the proportion of participants with HBV DNA \< 29 IU/mL in the TDF group was 69%. Missing data were treated as not achieving the primary endpoint.|Difference in proportions|-3.6|||||TWO_SIDED|95.0|-9.8|2.6|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.||2.6|-9.8|
74010646|NCT00258674|147572427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.307||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.307
74010647|NCT00258674|147572428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.551||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.551
74041222|NCT03657810|147634181|SUPERIORITY|||||||0.052|TWO_SIDED|95.0||||Type III P-Value are from the likelihood ration test from the logistic regression model with factors of treatment, gender, and investigator|Regression, Logistic|||||||0.052
74041223|NCT03004976|147634208|OTHER||Wilcoxon Mann-Whitney Odds|0.9|STANDARD_ERROR_OF_MEAN|0.248||0.71|TWO_SIDED|95.0|0.53|1.55||Wilcoxon Two Sample Test|Wilcoxon (Mann-Whitney)|||Primary efficacy analysis (mRS shift from baseline to 90 days)||1.55|0.53|0.71
74093006|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.91||||0.79|TWO_SIDED|95.0|-5.81|7.63||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||7.63|-5.81|0.790
74093007|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.5||||0.876|TWO_SIDED|95.0|-5.86|6.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||6.87|-5.86|0.876
74093008|NCT02504671|147737913|OTHER||Mean Difference (Net)|-1.3||||0.684|TWO_SIDED|95.0|-7.59|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||4.99|-7.59|0.684
74093009|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.86||||0.588|TWO_SIDED|95.0|-2.28|4.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||4.01|-2.28|0.588
74093010|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.9||||0.229|TWO_SIDED|95.0|-1.21|5.0||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||5.00|-1.21|0.229
74093011|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.41||||0.125|TWO_SIDED|95.0|-0.67|5.49||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||5.49|-0.67|0.125
74093012|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.6||||0.736|TWO_SIDED|95.0|-2.92|4.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||4.12|-2.92|0.736
74093013|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.72||||0.338|TWO_SIDED|95.0|-1.8|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||5.23|-1.80|0.338
74093014|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.92||||0.6|TWO_SIDED|95.0|-2.55|4.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||4.40|-2.55|0.600
74093015|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.26||||0.657|TWO_SIDED|95.0|-4.34|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||6.86|-4.34|0.657
74093016|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.12||||0.965|TWO_SIDED|95.0|-5.41|5.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||5.17|-5.41|0.965
74093017|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.12||||0.675|TWO_SIDED|95.0|-4.14|6.37||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||6.37|-4.14|0.675
74093018|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.32||||0.88|TWO_SIDED|95.0|-4.54|3.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||3.89|-4.54|0.880
74093019|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.17||||0.135|TWO_SIDED|95.0|-1.0|7.33||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||7.33|-1.00|0.135
74093020|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.57||||0.785|TWO_SIDED|95.0|-3.56|4.71||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||4.71|-3.56|0.785
74093021|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.55||||0.797|TWO_SIDED|95.0|-3.69|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.80|-3.69|0.797
74093022|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.0|||>|0.999|TWO_SIDED|95.0|-4.23|4.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.23|-4.23|>0.999
74093023|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.28||||0.896|TWO_SIDED|95.0|-3.91|4.46||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.46|-3.91|0.896
74093024|NCT02504671|147737913|OTHER||Mean Difference (Net)|-2.89||||0.424|TWO_SIDED|95.0|-10.02|4.24||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||4.24|-10.02|0.424
74093025|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.44||||0.898|TWO_SIDED|95.0|-7.16|6.29||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||6.29|-7.16|0.898
74093026|NCT02504671|147737913|OTHER||Mean Difference (Net)|-3.79||||0.26|TWO_SIDED|95.0|-10.42|2.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||2.84|-10.42|0.260
74093027|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.02||||0.603|TWO_SIDED|95.0|-2.85|4.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||4.90|-2.85|0.603
74093028|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.56||||0.068|TWO_SIDED|95.0|-0.26|7.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||7.39|-0.26|0.068
74093029|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.63||||0.174|TWO_SIDED|95.0|-1.17|6.43||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||6.43|-1.17|0.174
74093030|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.97||||0.334|TWO_SIDED|95.0|-2.04|5.98||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||5.98|-2.04|0.334
74093031|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.91||||0.153|TWO_SIDED|95.0|-1.09|6.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||6.91|-1.09|0.153
74093032|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.18||||0.279|TWO_SIDED|95.0|-1.78|6.13||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||6.13|-1.78|0.279
74093033|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.94||||0.584|TWO_SIDED|95.0|-5.04|8.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,Vitality|||8.91|-5.04|0.584
74093034|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.15||||0.346|TWO_SIDED|95.0|-3.44|9.73||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.73|-3.44|0.346
74093035|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.97||||0.37|TWO_SIDED|95.0|-3.55|9.48||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.48|-3.55|0.370
74093036|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.94||||0.045|TWO_SIDED|95.0|0.06|5.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||5.83|0.06|0.045
74093037|NCT02504671|147737913|OTHER||Mean Difference (Net)|4.11||||0.006|TWO_SIDED|95.0|1.22|7.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||7.01|1.22|0.006
74093038|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.89||||0.264|TWO_SIDED|95.0|-1.44|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS|||5.23|-1.44|0.264
74093039|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.55||||0.037|TWO_SIDED|95.0|0.22|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS|||6.88|0.22|0.037
74093040|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.16||||0.392|TWO_SIDED|95.0|-2.81|7.14||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||7.14|-2.81|0.392
74093041|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.65||||0.493|TWO_SIDED|95.0|-3.09|6.39||MMRM analysis adjusted for PCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.39|-3.09|0.493
74093042|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.16||||0.577|TWO_SIDED|95.0|-2.94|5.26||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||5.26|-2.94|0.577
74093043|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.1||||0.964|TWO_SIDED|95.0|-4.01|4.2||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||4.20|-4.01|0.964
74093044|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.97||||0.37|TWO_SIDED|95.0|-2.35|6.28||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||6.28|-2.35|0.370
74093045|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.25||||0.138|TWO_SIDED|95.0|-1.05|7.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||7.54|-1.05|0.138
74093046|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.36||||0.667|TWO_SIDED|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||7.56|-4.85|0.667
73879427|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.33|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.43|-1.33|<0.0001
73879428|NCT03192176|147297612|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.49|-0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.61|-1.49|<0.0001
73879429|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0873|TWO_SIDED|95.0|-0.81|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.06|-0.81|0.0873
74041224|NCT03004976|147634208|OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.223||0.87|TWO_SIDED|95.0|0.4|2.3|||Cumulative Logit Proportional Odds Model|||Additional analysis of the primary endpoint (mRS score at 90 days), adjusted for baseline mRS, baseline NIHSS, and institution.||2.3|0.4|0.87
74041225|NCT02141217|147634316|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|1.5|||||TWO_SIDED|95.0|-4.9|8.0||||||||8.0|-4.9|
74041226|NCT02141217|147634317|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|0.9|||||TWO_SIDED|95.0|-5.6|7.4||||||||7.4|-5.6|
74041227|NCT02141217|147634318|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|2.3|||||TWO_SIDED|95.0|-4.4|9.0||||||||9.0|-4.4|
74041228|NCT01899677|147634331|SUPERIORITY_OR_OTHER|||||||0.32|||||||Mann whitney U|||Mann Whitney U test was used to compare cytokine levels between groups.||||0.32
74041229|NCT01899677|147634332|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mann whitney U|||||||0.73
74041230|NCT01899677|147634333|SUPERIORITY_OR_OTHER|||||||0.66|||||||Mann whitney U|||||||0.66
74041231|NCT01899677|147634334|SUPERIORITY_OR_OTHER|||||||0.76|||||||Mann whitney U|||||||0.76
74041232|NCT01306032|147634344|SUPERIORITY_OR_OTHER|||||||0.034|||||||Log Rank|||||||0.034
74093047|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.79||||0.203|TWO_SIDED|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||7.56|-4.85|0.203
74093048|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.45||||0.023|TWO_SIDED|95.0|0.49|6.41||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain|||6.41|0.49|0.023
74093049|NCT02504671|147737913|OTHER||Mean Difference (Net)|5.08|||<|0.001|TWO_SIDED|95.0|2.14|8.03||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain|||8.03|2.14|<0.001
74041233|NCT01306032|147634344|SUPERIORITY_OR_OTHER|||||||0.68|||||||Log Rank|||||||0.68
74093050|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.11||||0.249|TWO_SIDED|95.0|-1.49|5.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain|||5.70|-1.49|0.249
74093051|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.43||||0.059|TWO_SIDED|95.0|-0.13|6.99||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain|||6.99|-0.13|0.059
74093052|NCT02504671|147737913|OTHER||Mean Difference (Net)|4.72||||0.134|TWO_SIDED|95.0|-1.47|10.9||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain|||10.90|-1.47|0.134
74093053|NCT02504671|147737913|OTHER||Mean Difference (Net)|5.2||||0.078|TWO_SIDED|95.0|-0.58|10.97||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain|||10.97|-0.58|0.078
74041234|NCT05014542|147634349|SUPERIORITY||Mean Difference (Final Values)|-42.8|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 15) - mean (WOMAC total of group C in Week 15)|WOMAC total analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
74093054|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.65||||0.275|TWO_SIDED|95.0|-1.32|4.62||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health|||4.62|-1.32|0.275
74093055|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.94||||0.199|TWO_SIDED|95.0|-1.03|4.91||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health|||4.91|-1.03|0.199
74041235|NCT05014542|147634350|SUPERIORITY||Mean Difference (Final Values)|-8.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain of group A at Week 15) - mean (WOMAC pain of group C at Week 15)|WOMAC pain analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at assessments.||||<.001
74093056|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.69||||0.654|TWO_SIDED|95.0|-2.36|3.74||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health|||3.74|-2.36|0.654
74093057|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.29||||0.138|TWO_SIDED|95.0|-0.74|5.33||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health|||5.33|-0.74|0.138
74041236|NCT05014542|147634351|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness of group A at Week 15) - mean (WOMAC stiffness of group C at Week 15)|WOMAC stiffness between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
74041237|NCT05014542|147634352|SUPERIORITY||Mean Difference (Final Values)|-30.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability of group A in Week 15) - mean (WOMAC functional disability of group C in Week 15)|WOMAC functional disability between groups at Week 15. The Shapiro-Wilk test (S-W) tests normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with a power of 95 % and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment (the mid-spread).||||<0.001
74041238|NCT05014542|147634353|SUPERIORITY||Mean Difference (Final Values)|-48.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS of group A in Week 15) - mean (VAS of group C in Week 15)|Visual Analogue Scale (VAS) was compared between groups at Week 15, when the acupuncture of group A ended. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) presented the statistical dispersion of sample data at specified assessments.||||<0.001
74041239|NCT05014542|147634354|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ of group A in Week 15) - mean (KDSQ of group C in Week 15)|The Kidney Deficiency Syndrome Questionnaire (KDSQ) was compared between groups in Week 15. The Shapiro-Wilk test (S-W) tests the normality of data distribution. The comparability of groups regarding the null hypothesis of similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were used to analyse the statistical dispersion of specified sample data at specified assessment.||||<0.001
74041240|NCT05014542|147634355|SUPERIORITY||Mean Difference (Final Values)|-774.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG of A group in Week 15) - mean (DRUG of C group in Week 15)|In Week 15, DRUG was compared between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
74041241|NCT05014542|147634356|SUPERIORITY||Mean Difference (Final Values)|0.009||||0.8493|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (A group L knee in Week 15) - mean (C group L knee in Week 15)|Active extension of left (L) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.8493
74041242|NCT05014542|147634356|SUPERIORITY||Mean Difference (Final Values)|-0.107||||0.69654|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (A group R knee in Week 15) - mean (C group R knee in Week 15)|Active extension of the right (R) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.69654
74041243|NCT05014542|147634357|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (active flexion L knee of group A at Week 15) - mean (active flexion L knee of group C at Week 15)|L knee flexion between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.490
74041244|NCT05014542|147634357|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.517|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (active flexion R knee of group A at Week 15) - mean (active flexion R knee of group C at Week 15)|Right (R) knee flexion between groups in Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.517
74041245|NCT05014542|147634358|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.083|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L upper leg of group A at Week 15) - mean (circumference of L upper leg of group C at Week 15)|Circumference of the left (L) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessment.||||0.083
74010648|NCT00258674|147572429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.927||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.927
74010649|NCT00258674|147572430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.308||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.308
74010650|NCT00258674|147572431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.867||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.867
74010651|NCT00258674|147572432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.807||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.807
74010652|NCT00258674|147572433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.702||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.702
74010653|NCT00258674|147572434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.413||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.413
74010654|NCT00258674|147572435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.996||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.996
74010655|NCT00258674|147572436|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.451||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.451
74010656|NCT00258674|147572437|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1||||0.447||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.447
74010657|NCT00258674|147572438|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.01||||0.936||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.936
74093058|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.77||||0.516|TWO_SIDED|95.0|-3.62|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health|||7.17|-3.62|0.516
74010658|NCT00258674|147572439|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.332||95.0||||A comparison of the claims vs. claims+MR arms was also conducted, giving a p-value of 0.537.|Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.332
74093059|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.35||||0.198|TWO_SIDED|95.0|-1.77|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health|||8.46|-1.77|0.198
74093060|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.15||||0.941|TWO_SIDED|95.0|-4.15|3.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health|||3.84|-4.15|0.941
74093061|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.05||||0.979|TWO_SIDED|95.0|-3.94|4.05||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health|||4.05|-3.94|0.979
74093062|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.4||||0.287|TWO_SIDED|95.0|-2.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health|||6.84|-2.03|0.287
74093063|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.45||||0.125|TWO_SIDED|95.0|-0.96|7.85||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health|||7.85|-0.96|0.125
74093064|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.15||||0.503|TWO_SIDED|95.0|-4.18|8.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Mental health|||8.49|-4.18|0.503
74093065|NCT02504671|147737913|OTHER||Mean Difference (Net)|5.01||||0.099|TWO_SIDED|95.0|-0.96|10.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24,Mental health|||10.98|-0.96|0.099
74093066|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.88||||0.268|TWO_SIDED|95.0|-1.45|5.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning|||5.21|-1.45|0.268
74093067|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.45||||0.147|TWO_SIDED|95.0|-0.87|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning|||5.77|-0.87|0.147
74093068|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.87||||0.145|TWO_SIDED|95.0|-0.99|6.73||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning|||6.73|-0.99|0.145
74093069|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.54||||0.014|TWO_SIDED|95.0|0.97|8.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning|||8.61|0.97|0.014
74093070|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.47||||0.856|TWO_SIDED|95.0|-4.66|5.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning|||5.61|-4.66|0.856
74093071|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.65||||0.793|TWO_SIDED|95.0|-4.24|5.55||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning|||5.55|-4.24|0.793
74093072|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.59||||0.778|TWO_SIDED|95.0|-3.51|4.69||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional|||4.69|-3.51|0.778
74093073|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.6||||0.773|TWO_SIDED|95.0|-4.7|3.5||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional|||3.50|-4.70|0.773
74093074|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.08||||0.631|TWO_SIDED|95.0|-3.34|5.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional|||5.49|-3.34|0.631
74093075|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.68||||0.23|TWO_SIDED|95.0|-1.71|7.07||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional|||7.07|-1.71|0.230
74093076|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.41||||0.901|TWO_SIDED|95.0|-6.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional|||6.84|-6.03|0.901
74093077|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.52||||0.412|TWO_SIDED|95.0|-3.54|8.59||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional|||8.59|-3.54|0.412
74093078|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.88||||0.234|TWO_SIDED|95.0|-1.22|4.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical|||4.98|-1.22|0.234
74093079|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.66||||0.094|TWO_SIDED|95.0|-0.46|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical|||5.77|-0.46|0.094
74093080|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.43||||0.423|TWO_SIDED|95.0|-2.08|4.94||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical|||4.94|-2.08|0.423
74093081|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.35||||0.061|TWO_SIDED|95.0|-0.16|6.86||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical|||6.86|-0.16|0.061
74093082|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.21||||0.657|TWO_SIDED|95.0|-4.16|6.57||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical|||6.57|-4.16|0.657
74093083|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.87||||0.737|TWO_SIDED|95.0|-4.22|5.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical|||5.95|-4.22|0.737
74093084|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.95||||0.165|TWO_SIDED|95.0|-1.22|7.11||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning|||7.11|-1.22|0.165
74093085|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.4||||0.109|TWO_SIDED|95.0|-0.77|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning|||7.56|-0.77|0.109
74093086|NCT02504671|147737913|OTHER||Mean Difference (Net)|1.98||||0.359|TWO_SIDED|95.0|-2.26|6.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning|||6.21|-2.26|0.359
74093087|NCT02504671|147737913|OTHER||Mean Difference (Net)|4.35||||0.043|TWO_SIDED|95.0|0.14|8.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning|||8.56|0.14|0.043
74093088|NCT02504671|147737913|OTHER||Mean Difference (Net)|-0.33||||0.923|TWO_SIDED|95.0|-7.15|6.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Social Functioning|||6.49|-7.15|0.923
74093089|NCT02504671|147737913|OTHER||Mean Difference (Net)|0.3||||0.927|TWO_SIDED|95.0|-6.11|6.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||6.70|-6.11|0.927
74093090|NCT02504671|147737913|OTHER||Mean Difference (Net)|4.64||||0.018|TWO_SIDED|95.0|0.82|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||8.46|0.82|0.018
74093091|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.34||||0.087|TWO_SIDED|95.0|-0.49|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Vitality|||7.17|-0.49|0.087
74093092|NCT02504671|147737913|OTHER||Mean Difference (Net)|2.64||||0.193|TWO_SIDED|95.0|-1.35|6.64||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality|||6.64|-1.35|0.193
74093093|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.97||||0.051|TWO_SIDED|95.0|-0.01|7.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality|||7.95|-0.01|0.051
74093094|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.36||||0.321|TWO_SIDED|95.0|-3.31|10.02||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Vitality|||10.02|-3.31|0.321
74093095|NCT02504671|147737913|OTHER||Mean Difference (Net)|3.13||||0.328|TWO_SIDED|95.0|-3.18|9.44||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.44|-3.18|0.328
74093096|NCT02504671|147737914|OTHER||Mean Difference (Net)|-0.65||||0.701|TWO_SIDED|95.0|-3.97|2.67||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||2.67|-3.97|0.701
74093097|NCT02504671|147737914|OTHER||Mean Difference (Net)|1.5||||0.37|TWO_SIDED|95.0|-1.79|4.78||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||4.78|-1.79|0.370
74093098|NCT02504671|147737914|OTHER||Mean Difference (Net)|2.55||||0.125|TWO_SIDED|95.0|-0.71|5.81||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||5.81|-0.71|0.125
74093099|NCT02504671|147737914|OTHER||Mean Difference (Net)|1.92||||0.292|TWO_SIDED|95.0|-1.66|5.5||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||5.50|-1.66|0.292
74093100|NCT02504671|147737914|OTHER||Mean Difference (Net)|6.11||||0.163|TWO_SIDED|95.0|-1.04|6.11||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT sscore|||6.11|-1.04|0.163
74093101|NCT02504671|147737914|OTHER||Mean Difference (Net)|3.08||||0.087|TWO_SIDED|95.0|-0.46|6.61||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||6.61|-0.46|0.087
74093102|NCT02504671|147737914|OTHER||Mean Difference (Net)|0.76||||0.808|TWO_SIDED|95.0|-5.4|6.92||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||6.92|-5.40|0.808
74093103|NCT02504671|147737914|OTHER||Mean Difference (Net)|-0.47||||0.874|TWO_SIDED|95.0|-6.31|5.38||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||5.38|-6.31|0.874
74093104|NCT02504671|147737914|OTHER||Mean Difference (Net)|-0.81||||0.78|TWO_SIDED|95.0|-6.58|4.95||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,FACIT score|||4.95|-6.58|0.780
74093105|NCT02504671|147737914|OTHER||Mean Difference (Net)|3.57||||0.033|TWO_SIDED|95.0|0.29|6.85||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||6.85|0.29|0.033
74093106|NCT02504671|147737914|OTHER||Mean Difference (Net)|2.81||||0.094|TWO_SIDED|95.0|-0.48|6.1||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||6.10|-0.48|0.094
74093107|NCT02504671|147737914|OTHER||Mean Difference (Net)|3.92||||0.032|TWO_SIDED|95.0|0.34|7.49||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||7.49|0.34|0.032
74093108|NCT02504671|147737914|OTHER||Mean Difference (Net)|5.33||||0.004|TWO_SIDED|95.0|1.77|8.89||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||8.89|1.77|0.004
74093109|NCT02504671|147737914|OTHER||Mean Difference (Net)|0.73||||0.808|TWO_SIDED|95.0|-5.19|6.64||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||6.64|-5.19|0.808
74093110|NCT02504671|147737914|OTHER||Mean Difference (Net)|1.87||||0.511|TWO_SIDED|95.0|-3.74|7.48||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||7.48|-3.74|0.511
74093111|NCT02504671|147737915|OTHER||Mean Difference (Net)|-0.07||||0.888|TWO_SIDED|95.0|-1.04|0.9||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.90|-1.04|0.888
73879430|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0124|TWO_SIDED|95.0|-0.97|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.12|-0.97|0.0124
73879431|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.0014|TWO_SIDED|95.0|-1.12|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.27|-1.12|0.0014
73879432|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0479|TWO_SIDED|95.0|-0.68|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.00|-0.68|0.0479
73879433|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2342|TWO_SIDED|95.0|-0.54|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.13|-0.54|0.2342
73879434|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.007|TWO_SIDED|95.0|-0.84|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.13|-0.84|0.0070
73879435|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4291|TWO_SIDED|95.0|-0.49|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.21|-0.49|0.4291
73879436|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0076|TWO_SIDED|95.0|-0.83|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.13|-0.83|0.0076
73879437|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.1506|TWO_SIDED|95.0|-0.62|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.10|-0.62|0.1506
73879438|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.5479|TWO_SIDED|95.0|-0.44|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.24|-0.44|0.5479
73879439|NCT03192176|147297612|SUPERIORITY||LSMean differencce|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.1427|TWO_SIDED|95.0|-0.57|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.08|-0.57|0.1427
73879440|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1498|TWO_SIDED|95.0|-0.56|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.09|-0.56|0.1498
74041246|NCT05014542|147634358|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.084|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R upper leg of group A at Week 15) - mean (circumference of R upper leg of group C at Week 15)|Circumference of the right (R) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessments.||||0.084
74041247|NCT05014542|147634359|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.341|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L knee of group A at Week 15) - mean (circumference of L knee of group C at Week 15)|Circumference of the left (L) knee in Week 15 was analysed between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.341
74093112|NCT02504671|147737915|OTHER||Mean Difference (Net)|-0.5||||0.307|TWO_SIDED|95.0|-1.46|0.46||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.46|-1.46|0.307
74093113|NCT02504671|147737915|OTHER||Mean Difference (Net)|-0.99||||0.041|TWO_SIDED|95.0|-1.95|-0.04||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||-0.04|-1.95|0.041
74093114|NCT02504671|147737915|OTHER||Mean Difference (Net)|-0.64||||0.191|TWO_SIDED|95.0|-1.6|0.32||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||0.32|-1.60|0.191
74093115|NCT02504671|147737915|OTHER||Mean Difference (Net)|-1.2||||0.014|TWO_SIDED|95.0|-2.16|-0.24||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.24|-2.16|0.014
74093116|NCT02504671|147737915|OTHER||Mean Difference (Net)|-1.39||||0.004|TWO_SIDED|95.0|-2.34|-0.45||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.45|-2.34|0.004
74041248|NCT05014542|147634359|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.317|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R knee of group A at Week 15) - mean (circumference of R knee of group C at Week 15)|Circumference of the right (R) knee in between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.317
74041249|NCT05014542|147634360|SUPERIORITY||Mean Difference (Final Values)|-33.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 24) -mean (WOMAC total of group C in Week 24)|WOMAC total was analysed in Week 24 between groups, nine weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tested the normality of the distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
74041250|NCT05014542|147634361|SUPERIORITY||Mean Difference (Final Values)|-6.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain of group A at Week 24) - mean (WOMAC pain of group C at Week 24)|WOMAC pain was analysed between groups 9 weeks after acupuncture ended in Week 24. The Shapiro-Wilk test (S-W) tested the normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data (the mid-spread).||||<.001
74041251|NCT05014542|147634362|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness of group A in Week 24) - mean (WOMAC stiffness of group C in Week 24)|WOMAC stiffness between groups A and C in Week 24, 9 weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tests the normality of distribution. Group comparability was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
74041252|NCT05014542|147634363|SUPERIORITY||Mean Difference (Final Values)|-24.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability of group A in Week 24) - mean (WOMAC functional disability of group C in Week 24)|WOMAC functional disability at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests the normality of data. The comparability of groups regarding specified variables (to accept or reject the null hypothesis of comparability) was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
74041253|NCT05014542|147634364|SUPERIORITY||Mean Difference (Final Values)|-45.7|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 24 of group A) - mean (VAS in Week 24 of group C)|VAS was compared between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
74041254|NCT05014542|147634365|SUPERIORITY||Mean Difference (Final Values)|-11.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 24 of group A) - mean (KDSQ in Week 24 of group C)|KDSQ between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
74041255|NCT05014542|147634366|SUPERIORITY||Mean Difference (Final Values)|-581.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 24 of group A) - mean (DRUG in Week 24 of group C)|The DRUG between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
74041256|NCT05014542|147634367|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||mean (Act ext L of A group in Week 24) - mean (Act ext L of C group in Week 24)|Left (L) knee analysis between groups A and C in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability was tested with the Mann-Whitney U test, with 95% statistical power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessment.||||
74041257|NCT05014542|147634367|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||mean (Act ext R knee of A group in Week 24) - mean (Act ext R knee of C group in Week 24)|Right (R) knee analysis between groups at Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability between groups was tested by the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment.||||
74041258|NCT05014542|147634368|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.953|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (L knee act flexion of group A in Week 24) - mean (L knee act flexion of group C in Week 24)|Left (L) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of specified sample data at a specified assessment (time-point).||||0.953
74010659|NCT00258674|147572440|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.01||||0.86||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.860
74010660|NCT00258674|147572441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.382||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.382
74010661|NCT00258674|147572442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.988||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.988
74010662|NCT00258674|147572443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.685||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.685
74010663|NCT03715153|147572444|SUPERIORITY||Estimate of the adjusted difference|0.35|STANDARD_ERROR_OF_MEAN|0.71||0.617|TWO_SIDED|95.0|-1.04|1.75|||t-test, 2 sided|General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline.|Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||1.75|-1.04|0.617
74010664|NCT03715153|147572445|SUPERIORITY||Estimate of the adjusted difference|0.48|STANDARD_ERROR_OF_MEAN|3.26|||TWO_SIDED|95.0|-5.91|6.88|||||General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||6.88|-5.91|
74010665|NCT03715153|147572446|SUPERIORITY||Estimate of the adjusted difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.24|0.16|||||Rank-based analysis (Wilcoxon scores) including terms for fixed categorical effects of treatment, country and gender. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||0.16|-0.24|
74010666|NCT03715153|147572447|SUPERIORITY||Estimate of the adjusted difference|0.16|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|-1.42|1.75|||||General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||1.75|-1.42|
74010667|NCT03715153|147572451|SUPERIORITY||Estimate of the adjusted difference|-0.26|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|95.0|-5.12|4.59||||||||4.59|-5.12|
74010668|NCT01412554|147572477|OTHER|Only descriptive statistics|||||<|0.05|||||||Spearman|The degree of tracking was assessed by Spearman's rank or Pearson's correlation coefficient||Only an observational follow-up study|The degree of tracking was assessed by Spearman's rank or Pearson's correlation coefficient|||<0.05
74010669|NCT01806857|147572485|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Random Effects Model|||||||0.0003
74010670|NCT01806857|147572489|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Random Effects Model|||||||0.0001
74010671|NCT02044133|147572530|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74010672|NCT01251653|147572566|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|81.27|STANDARD_DEVIATION|63.3||0.4815|TWO_SIDED|90.0|44.863|147.205|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||147.205|44.863|0.4815
74010673|NCT01251653|147572566|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|95.36|STANDARD_DEVIATION|15.4||0.0149|TWO_SIDED|90.0|84.139|108.077|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||108.077|84.139|0.0149
74010674|NCT01251653|147572566|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|88.12|STANDARD_DEVIATION|9.2||0.0208|TWO_SIDED|90.0|81.778|94.964|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||94.964|81.778|0.0208
74010675|NCT01251653|147572567|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|141.36|STANDARD_DEVIATION|14.7||0.8715|TWO_SIDED|90.0|115.848|172.495|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||172.495|115.848|0.8715
74010676|NCT01251653|147572567|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|77.42|STANDARD_DEVIATION|16.8||0.6805|TWO_SIDED|90.0|68.516|87.473|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||87.473|68.516|0.6805
74010677|NCT01251653|147572567|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|83.95|STANDARD_DEVIATION|14.3||0.2327|TWO_SIDED|90.0|74.794|94.217|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||94.217|74.794|0.2327
74010678|NCT01251653|147572568|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|136.11|STANDARD_DEVIATION|26.3||0.7759|TWO_SIDED|90.0|112.09|165.29|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||165.29|112.09|0.7759
74010679|NCT01251653|147572569|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|118.41|STANDARD_DEVIATION|31.6||0.3359|TWO_SIDED|90.0|94.81|147.88|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||147.88|94.81|0.3359
74010680|NCT01251653|147572572|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|93.69|STANDARD_DEVIATION|19.5||0.0349|TWO_SIDED|90.0|81.352|107.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||107.890|81.352|0.0349
74010681|NCT01251653|147572572|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|98.11|STANDARD_DEVIATION|30.4||0.0405|TWO_SIDED|90.0|81.053|118.76|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||118.760|81.053|0.0405
74010682|NCT01251653|147572573|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|90.78|STANDARD_DEVIATION|22.8||0.0728|TWO_SIDED|90.0|78.566|104.901|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||104.901|78.566|0.0728
74010683|NCT01251653|147572573|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|85.74|STANDARD_DEVIATION|48.9||0.3294|TWO_SIDED|90.0|65.561|112.138|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||112.138|65.561|0.3294
74010684|NCT00847145|147572577|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off levels for the vaccine antigen measles is ≥255 mIU/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-5.0|2.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the measles antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Measles antigen was greater than -10%.||2|-5|
74041259|NCT05014542|147634368|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (R knee act flexion of group A in Week 24) - mean (R knee act flexion of group C in Week 24)|Right (R) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of comparability was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of sample data at an assessment.||||0.491
74093117|NCT02504671|147737915|OTHER||Mean Difference (Net)|-0.36||||0.656|TWO_SIDED|95.0|-1.94|1.23||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.23|-1.94|0.656
73879441|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0103|TWO_SIDED|95.0|-0.79|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.11|-0.79|0.0103
73879442|NCT03192176|147297612|SUPERIORITY||LSMean differencce|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.8984|TWO_SIDED|95.0|-0.36|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.32|-0.36|0.8984
73879443|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0095|TWO_SIDED|95.0|-0.79|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.11|-0.79|0.0095
73879444|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.137|TWO_SIDED|95.0|-0.6|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.08|-0.60|0.1370
73879445|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.4223|TWO_SIDED|95.0|-0.46|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.19|-0.46|0.4223
73879446|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3265|TWO_SIDED|95.0|-0.5|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.17|-0.50|0.3265
73879447|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0852|TWO_SIDED|95.0|-0.62|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.04|-0.62|0.0852
73879448|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0021|TWO_SIDED|95.0|-0.91|-0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.21|-0.91|0.0021
73879449|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5717|TWO_SIDED|95.0|-0.45|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.25|-0.45|0.5717
73879450|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0084|TWO_SIDED|95.0|-0.82|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.12|-0.82|0.0084
73879451|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0277|TWO_SIDED|95.0|-0.75|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.04|-0.75|0.0277
74010685|NCT00847145|147572577|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the vaccine antigen mumps is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody (Ab) units to be greater than -10%.|Percentage group difference|0.0|||||TWO_SIDED|95.0|-5.0|5.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B(2a), if for the mumps antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Mumps antigen was greater than -10%.||5|-5|
74010686|NCT00847145|147572577|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the vaccine antigen rubella is ≥10 IU/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-4.0|1.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the rubella antigen(two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for rubella antigen was greater than -10%.||1|-4|
74010687|NCT00847145|147572577|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off value for the vaccine antigen varicella is ≥1.25 gpELISA units/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for varicella antigen was greater than -10%.||3|-6|
74093118|NCT02504671|147737915|OTHER||Mean Difference (Net)|0.07||||0.928|TWO_SIDED|95.0|-1.43|1.57||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.57|-1.43|0.928
74093119|NCT02504671|147737915|OTHER||Mean Difference (Net)|-0.2||||0.788|TWO_SIDED|95.0|-1.68|1.28||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.28|-1.68|0.788
74093120|NCT02504671|147737915|OTHER||Mean Difference (Net)|-1.26||||0.01|TWO_SIDED|95.0|-2.22|-0.3||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||-0.30|-2.22|0.010
74093121|NCT02504671|147737915|OTHER||Mean Difference (Net)|-0.93||||0.059|TWO_SIDED|95.0|-1.89|0.03||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.03|-1.89|0.059
74041260|NCT05014542|147634369|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.261|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L upper leg of group A in Week 24) - mean (circumference of L upper leg of group C in Week 24)|Circumference of the left (L) upper leg between groups in Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of a distribution. The comparability of groups regarding specified variables to accept or reject the hypothesis of groups comparability was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.||||0.261
74041261|NCT05014542|147634369|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.273|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R upper leg of group A in Week 24) - mean (circumference of R upper leg of group C in Week 24)|Circumference of the R upper leg between groups at Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of distribution. The comparability of groups regarding specified variables (null hypothesis) was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.||||0.273
74041262|NCT05014542|147634370|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.445|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L knees in Week 24 of group A) - mean (circumference of L knees in Week 24 of group C)|Circumference of left (L) knees in Week 24, in between-groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at an assessment.||||0.445
74041263|NCT05014542|147634370|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R knees in Week 24 of group A) - mean (circumference of R knees in Week 24 of group C)|Circumference of right (R) knees at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at assessments.||||0.260
74041264|NCT05014542|147634371|SUPERIORITY||Mean Difference (Final Values)|-34.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 39) - mean (WOMAC total of group A in Week 0)|Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total of group A in Week 39 (24 weeks after acupunctures ended) was compared with the pre-experimental baseline assessment by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. The null hypothesis at weeks 0 and 39 was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of the sample.||||<0.001
74041265|NCT05014542|147634371|SUPERIORITY||Mean Difference (Final Values)|-39.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total in Week 39 of group C) - mean (WOMAC total in Week 0 of group C).|WOMAC total of group C in Week 39 was tested for the significance level and mean difference by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. WOMAC total at Week 0 (pre-experimental baseline assessment) and Week 39 were compared to test the null hypothesis of group comparability by the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of a sample.||||< 0.001
74041266|NCT05014542|147634372|SUPERIORITY||Mean Difference (Final Values)|-6.2|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain in Week 39 of group A) - mean (WOMAC pain in Week 0 of group A)|The pain subscale of the WOMAC index of group A in Week 39 (24 weeks after acupunctures ended) was compared with baseline by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of sample data at assessments.||||<0.001
74093122|NCT02504671|147737915|OTHER||Mean Difference (Net)|-1.44||||0.003|TWO_SIDED|95.0|-2.4|-0.48||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.48|-2.40|0.003
74093123|NCT02504671|147737915|OTHER||Mean Difference (Net)|-1.57||||0.001|TWO_SIDED|95.0|-2.53|-0.62||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.62|-2.53|0.001
74093124|NCT02504671|147737915|OTHER||Mean Difference (Net)|-0.76||||0.324|TWO_SIDED|95.0|-2.28|0.76||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||0.76|-2.28|0.324
74093125|NCT02504671|147737915|OTHER||Mean Difference (Net)|-0.58||||0.432|TWO_SIDED|95.0|-2.02|0.87||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||0.87|-2.02|0.432
74093126|NCT00866658|147737926|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-1.116|-0.65||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%),sulfonylurea use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 145 patients in each arm would provide a power of 90% assuming common standard deviation of 1.3% with a 2-sided t test at 5% significance level.||-0.650|-1.116|<0.0001
74093127|NCT00609518|147737946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.1|0.28|||Linear probability model|||||0.28|-0.10|
74093128|NCT00609518|147737947|SUPERIORITY_OR_OTHER|||||||0.4902||95.0|||||Fisher Exact|||||||0.4902
74093129|NCT00609518|147737948|SUPERIORITY_OR_OTHER|||||||0.6791||95.0|||||Log Rank|||||||0.6791
74093130|NCT00609518|147737948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.54|1.49|||Regression, Cox|Treatment was the covariate included in this model.||||1.49|0.54|
74093131|NCT00609518|147737949|SUPERIORITY_OR_OTHER|||||||0.587||95.0|||||Log Rank|||||||0.5870
74093132|NCT00609518|147737949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.57|1.38|||Regression, Cox|Treatment was the covariate included in this model.||||1.38|0.57|
74093133|NCT01687478|147737950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.62|||||TWO_SIDED|95.0|-5.04|1.8|||||The Confidence Interval is based on the treatment difference LS Mean changes from baseline between Olanzapine + Fluoxetine and Placebo + Fluoxetine.|||1.80|-5.04|
74093134|NCT05855616|147737960|OTHER||Odds Ratio (OR)|0.533||||1|TWO_SIDED|95.0|0.048|5.892|||t-test, 1 sided|||||5.892|0.048|1.00
74041267|NCT05014542|147634372|SUPERIORITY||Mean Difference (Final Values)|-7.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain in Week 39 of group C) - mean (WOMAC pain in Week 0 of group C)|The pain subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.||||<0.001
74093135|NCT05855616|147737961|OTHER||Odds Ratio (OR)|0.176||||0.013|TWO_SIDED|95.0|0.039|0.79|||t-test, 1 sided|||||0.790|0.039|0.013
74093136|NCT05855616|147737963|OTHER|||||||0.137|||||||Chi-squared, Corrected|||||||0.137
74041268|NCT05014542|147634373|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness in Week 39 of group A) - mean (WOMAC stiffness in Week 0 of group A)|The stiffness subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
74093137|NCT05855616|147737964|OTHER|||||||0.764|||||||Chi-squared, Corrected|||||||0.764
74093138|NCT05855616|147737965|OTHER|||||||0.055|||||||Chi-squared, Corrected|||||||0.055
74093139|NCT01276301|147737966|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.95|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|90.0|98.87|107.02|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||107.02|98.87|
74093140|NCT01276301|147737967|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|92.39|STANDARD_ERROR_OF_MEAN|12.7|||TWO_SIDED|90.0|85.38|99.97|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||99.97|85.38|
74093141|NCT01276301|147737968|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.77|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|90.0|98.87|106.83|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||106.83|98.87|
74093142|NCT04442490|147737982|SUPERIORITY||Least Squares (LS) Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0141|TWO_SIDED|95.0|-3.1|-0.3|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|||-0.3|-3.1|0.0141
74093143|NCT04442490|147737983|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.1193|TWO_SIDED|95.0|-0.4|0.0|||MMRM||Model used was the MMRM with treatment (SAGE-217 or placebo), baseline CGI-S score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|||0.0|-0.4|0.1193
74093144|NCT04442490|147737984|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|-4.0|-2.0|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 3||-2.0|-4.0|<0.0001
74093145|NCT04442490|147737984|SUPERIORITY||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-3.8|-1.4|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 8||-1.4|-3.8|<0.0001
74093146|NCT04442490|147737984|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.76||0.2344|TWO_SIDED|95.0|-2.4|0.6|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 42||0.6|-2.4|0.2344
74093147|NCT04442490|147737985|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0599|TWO_SIDED|95.0|0.99|1.98|||Generalized Estimating Equation Model|||Day 15|Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.98|0.99|0.0599
74093148|NCT04442490|147737985|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0889|TWO_SIDED|95.0|0.95|1.94|||GEE Model|||Day 42|Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure.Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.94|0.95|0.0889
74093149|NCT04442490|147737986|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5495|TWO_SIDED|95.0|0.76|1.66|||GEE Model|||Day 15|Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.66|0.76|0.5495
74093150|NCT04442490|147737986|SUPERIORITY||Odds Ratio (OR)|1.09||||0.679|TWO_SIDED|95.0|0.74|1.6|||GEE Model|||Day 42|Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.60|0.74|0.6790
74093151|NCT04442490|147737987|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0191|TWO_SIDED|95.0|1.07|2.16|||GEE Model|||Placebo, SAGE-217|Model used was a GEE for binary response model, with factors for treatment, CGI-S baseline score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having CGI-I response for participants treated with SAGE-217 relative to that for participants treated with placebo.|2.16|1.07|0.0191
74093152|NCT04442490|147737988|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.05||0.0238|TWO_SIDED|95.0|-4.4|-0.3|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline MADRS total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure|Placebo, SAGE-217||-0.3|-4.4|0.0238
74093153|NCT04442490|147737989|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.0199|TWO_SIDED|95.0|-2.5|-0.2|||MMRM||Model used was MMRM with treatment (SAGE-217/placebo), baseline HAM-A total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Placebo, SAGE-217||-0.2|-2.5|0.0199
74093154|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.5||0.3216|TWO_SIDED|95.0|-0.5|1.5|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 8||1.5|-0.5|0.3216
74093155|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.53||0.1247|TWO_SIDED|95.0|-0.2|1.8|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 15||1.8|-0.2|0.1247
74093156|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.56||0.1111|TWO_SIDED|95.0|-0.2|2.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 28||2.0|-0.2|0.1111
73879452|NCT03192176|147297612|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.4627|TWO_SIDED|95.0|-0.46|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.21|-0.46|0.4627
73879453|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.94||0.0142|TWO_SIDED|95.0|-8.62|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.97|-8.62|0.0142
73879454|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-11.73|-4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-4.05|-11.73|<0.0001
73879455|NCT03192176|147297613|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-12.98|-5.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-5.31|-12.98|<0.0001
73879456|NCT03192176|147297613|SUPERIORITY||LSMean difference|-10.5|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-14.39|-6.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-6.61|-14.39|<0.0001
73879457|NCT03192176|147297613|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|1.98||0.0819|TWO_SIDED|95.0|-7.36|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.44|-7.36|0.0819
73879458|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.95||0.0004|TWO_SIDED|95.0|-10.78|-3.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.09|-10.78|0.0004
73879459|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.94||0.0005|TWO_SIDED|95.0|-10.69|-3.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.05|-10.69|0.0005
73879460|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|1.98||0.038|TWO_SIDED|95.0|-8.01|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.23|-8.01|0.0380
73879461|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.99||0.0002|TWO_SIDED|95.0|-11.46|-3.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-3.64|-11.46|0.0002
73879462|NCT03192176|147297613|SUPERIORITY||LSMean differencce|-8.1|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-11.96|-4.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.17|-11.96|<0.0001
73879463|NCT03192176|147297613|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-13.17|-5.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-5.25|-13.17|<0.0001
73879464|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.02||0.0245|TWO_SIDED|95.0|-8.52|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.59|-8.52|0.0245
73879465|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.99||0.0031|TWO_SIDED|95.0|-9.83|-2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.01|-9.83|0.0031
73887972|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|146.6||||0.0019|TWO_SIDED|95.0|54.8|238.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||238.4|54.8|0.0019
74093157|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.59||0.1449|TWO_SIDED|95.0|-0.3|2.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 42||2.0|-0.3|0.1449
74093158|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.8242|TWO_SIDED|95.0|-1.3|1.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Role-Physical Domain Score: Change from Baseline at Day 8||1.0|-1.3|0.8242
74093159|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.62||0.8329|TWO_SIDED|95.0|-1.4|1.1|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 15||1.1|-1.4|0.8329
74093160|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.8127|TWO_SIDED|95.0|-1.4|1.1|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 28||1.1|-1.4|0.8127
74093161|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.64||0.5435|TWO_SIDED|95.0|-0.9|1.6|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 42||1.6|-0.9|0.5435
74093162|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.63||0.3551|TWO_SIDED|95.0|-0.7|1.8|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 8||1.8|-0.7|0.3551
74093163|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.68||0.7495|TWO_SIDED|95.0|-1.1|1.6|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 15||1.6|-1.1|0.7495
74093164|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.6471|TWO_SIDED|95.0|-1.1|1.7|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 28||1.7|-1.1|0.6471
74093165|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.75||0.1832|TWO_SIDED|95.0|-0.5|2.5|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 42||2.5|-0.5|0.1832
74093166|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.5||0.0168|TWO_SIDED|95.0|0.2|2.2|||MMRM|||General Health Domain Score: Change from Baseline at Day 8||2.2|0.2|0.0168
74093167|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.54||0.0787|TWO_SIDED|95.0|-0.1|2.0|||MMRM|||General Health Domain Score: Change from Baseline at Day 15||2.0|-0.1|0.0787
74093168|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.59||0.4273|TWO_SIDED|95.0|-0.7|1.6|||MMRM|||General Health Domain Score: Change from Baseline at Day 28||1.6|-0.7|0.4273
74093169|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.0938|TWO_SIDED|95.0|-0.2|2.2|||MMRM|||General Health Domain Score: Change from Baseline at Day 42||2.2|-0.2|0.0938
74093170|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.88||0.0033|TWO_SIDED|95.0|0.9|4.3|||MMRM|||Vitality Domain Score: Change from Baseline at Day 8||4.3|0.9|0.0033
74093171|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.03||0.0029|TWO_SIDED|95.0|1.1|5.1|||MMRM|||Vitality Domain Score: Change from Baseline at Day 15||5.1|1.1|0.0029
74093172|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.04||0.0791|TWO_SIDED|95.0|-0.2|3.9|||MMRM|||Vitality Domain Score: Change from Baseline at Day 28||3.9|-0.2|0.0791
74093173|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.12||0.0761|TWO_SIDED|95.0|-0.2|4.2|||MMRM|||Vitality Domain Score: Change from Baseline at Day 42||4.2|-0.2|0.0761
74093174|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.91||0.1568|TWO_SIDED|95.0|-0.5|3.1|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 8||3.1|-0.5|0.1568
74093175|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.99||0.2807|TWO_SIDED|95.0|-0.9|3.0|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 15||3.0|-0.9|0.2807
74093176|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.7751|TWO_SIDED|95.0|-1.8|2.4|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 28||2.4|-1.8|0.7751
74093177|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.07||0.0913|TWO_SIDED|95.0|-0.3|3.9|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 42||3.9|-0.3|0.0913
74093178|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.05||0.2863|TWO_SIDED|95.0|-0.9|3.2|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 8||3.2|-0.9|0.2863
74093179|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.13||0.1801|TWO_SIDED|95.0|-0.7|3.7|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 15||3.7|-0.7|0.1801
74093180|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.16||0.1107|TWO_SIDED|95.0|-0.4|4.1|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 28||4.1|-0.4|0.1107
74093181|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.23||0.3274|TWO_SIDED|95.0|-1.2|3.6|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 42||3.6|-1.2|0.3274
74093182|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.93||0.0873|TWO_SIDED|95.0|-0.2|3.4|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 8||3.4|-0.2|0.0873
73887973|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|132.7||||0.0049|TWO_SIDED|95.0|40.8|224.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||224.5|40.8|0.0049
74010688|NCT00847145|147572577|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the varicella vaccine antigen is ≥5 gp ELISA units/ml (seroprotection) to be greater than -10%.|Percentage group difference|-2.0|||||TWO_SIDED|95.0|-11.0|7.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of the subjects with antibody response greater than or equal to the specified cut-off value for varicella antigen was greater than -10%.||7|-11|
74041269|NCT05014542|147634373|SUPERIORITY||Mean Difference (Final Values)|-3.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness in Week 39 of group C) - mean (WOMAC stiffness in Week 0 of group C)|The stiffness subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.||||<0.001
74041270|NCT05014542|147634374|SUPERIORITY||Mean Difference (Final Values)|-25.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability in Week 39 of group A) - mean(WOMAC functional disability in Week 0 of group A)|The functional disability subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
74041271|NCT05014542|147634374|SUPERIORITY||Mean Difference (Final Values)|-29.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability in Week 39 of group C) - mean (WOMAC functional disability in Week 0 of group C)|The functional disability subscale of the WOMAC index of group C in Week 39 (when acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
74041272|NCT05014542|147634375|SUPERIORITY||Mean Difference (Final Values)|-41.2|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 39 of group A) - mean (VAS in Week 0 of group A)|VAS of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
74041273|NCT05014542|147634375|SUPERIORITY||Mean Difference (Final Values)|-31.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 39 of group C) - mean (VAS in Week 0 of group C)|VAS of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||< 0.001
74041274|NCT05014542|147634376|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 39 of group A) - mean (KDSQ in Week 0 of group A)|KDSQ of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
74041275|NCT05014542|147634376|SUPERIORITY||Mean Difference (Final Values)|-11.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 39 of group C) - mean (KDSQ in Week 0 of group C)|KDSQ of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
74041276|NCT05014542|147634377|SUPERIORITY||Mean Difference (Final Values)|-361.4||||0.204|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 39 of group A) - mean (DRUG in Week 0 of group A)|The DRUG of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||0.204
74041277|NCT05014542|147634377|SUPERIORITY||Mean Difference (Final Values)|-305.4||||0.134|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 39 of group C) - mean (DRUG in Week 0 of group C)|The DRUG of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||0.134
74093183|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.05||0.0871|TWO_SIDED|95.0|-0.3|3.9|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 15||3.9|-0.3|0.0871
74041278|NCT05014542|147634378|SUPERIORITY||Mean Difference (Final Values)|-7.53|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (Lequesne index in Week 24 of A group) - mean (Lequesne index in Week 24 of C group)|The Lequesne index in Week 24 compared two confirmed comparable groups (at baseline), 9 weeks after acupuncture treatment in group A ended, while the C group was still a control. The Shapiro-Wilk test (S-W) tests normality distribution. The between-group comparability test at Week 24 was provided to accept or reject the null hypothesis by the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion.||||< 0.001
74041279|NCT05067452|147634436|SUPERIORITY||Slope|-0.092|STANDARD_ERROR_OF_MEAN|0.721||0.9|TWO_SIDED|95.0|-1.59|1.4|||ANCOVA|||||1.40|-1.59|0.900
74041280|NCT05067452|147634437|SUPERIORITY||Slope|1.37|STANDARD_ERROR_OF_MEAN|0.945||0.146|TWO_SIDED|95.0|-0.478|3.23|||Mixed Models Analysis|||||3.23|-0.478|0.146
74041281|NCT05067452|147634438|SUPERIORITY||Risk Difference (RD)|0.235|STANDARD_ERROR_OF_MEAN|0.212||0.281|TWO_SIDED|95.0|-0.207|0.677|||ANCOVA|Linear regression used with the binary outcome (linear probability model)||||0.677|-0.207|0.281
74041282|NCT05067452|147634439|SUPERIORITY||Risk Difference (RD)|0.354|STANDARD_ERROR_OF_MEAN|0.211||0.094|TWO_SIDED|95.0|-0.06|0.768|||Mixed Models Analysis|Linear regression used with the binary outcome (linear probability model)||||0.768|-0.060|0.094
74041283|NCT05067452|147634440|SUPERIORITY||Slope|2.18|STANDARD_ERROR_OF_MEAN|5.11||0.669|TWO_SIDED|95.0|-7.83|12.2|||Mixed Models Analysis|||||12.2|-7.83|0.669
74041284|NCT05067452|147634441|SUPERIORITY||Slope|-0.024|STANDARD_ERROR_OF_MEAN|0.367||0.949|TWO_SIDED|95.0|-0.695|0.743|||Mixed Models Analysis|||||0.743|-0.695|0.949
74041285|NCT05067452|147634442|SUPERIORITY||Slope|-0.54|STANDARD_ERROR_OF_MEAN|0.53||0.308|TWO_SIDED|95.0|-1.58|0.679|||Mixed Models Analysis|||||0.679|-1.58|0.308
74041286|NCT05067452|147634443|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|1.91||0.593|TWO_SIDED|95.0|-4.77|0.499|||Mixed Models Analysis|||||0.499|-4.77|0.593
74041287|NCT05067452|147634444|SUPERIORITY||Slope|-2.63|STANDARD_ERROR_OF_MEAN|1.65||0.112|TWO_SIDED|95.0|-5.86|0.611|||Mixed Models Analysis|||||0.611|-5.86|0.112
74041288|NCT05067452|147634447|SUPERIORITY||Slope|-2.66|STANDARD_ERROR_OF_MEAN|2.85||0.349|TWO_SIDED|95.0|-8.25|2.92|||Mixed Models Analysis|||||2.92|-8.25|0.349
74041289|NCT00091962|147634516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001||||0.001|TWO_SIDED|95.0||||repeated measures mixed-effect model with treatment, time (4 time points), and sex; all 2- and 3-factor interaction terms with subject intercepts were treated as a random effect to account for individual differences at randomization.|Mixed Models Analysis|||||||0.001
74041290|NCT01170221|147634519|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measure (early clinical response at the 48-72 Hour Visit) between the tedizolid group and the linezolid group was calculated using the ITT analysis set. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.|Risk Difference (RD)|0.1||||||95.0|-6.1|6.2|||||Risk difference corresponds to tedizolid clinical response rate minus linezolid clinical response rate. The confidence interval was calculated using the Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.|The primary objective is to determine the noninferiority in the early clinical response rate of oral tedizolid phosphate compared with that of oral linezolid treatment at the 48-72 Hour Visit in the ITT Analysis Set in patients with ABSSSI.||6.2|-6.1|
74041291|NCT01170221|147634520|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI will be calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-2.6|||||TWO_SIDED|95.0|-9.6|4.2||Hierarchical testing procedure of Westfall and Krishen used to control for inflation of the overall type I error rate. If NI is declared for the primary, NI will be tested for the secondary outcomes in this order: Secondary Outcomes Measures 2 to 5.|||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||4.2|-9.6|
74041292|NCT01170221|147634521|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-7.7|5.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||5.4|-7.7|
74041293|NCT01170221|147634522|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-5.8|4.9|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||4.9|-5.8|
74041294|NCT01170221|147634523|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.8|||||TWO_SIDED|95.0|-4.6|3.0|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||3.0|-4.6|
74041295|NCT01170221|147634524|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.5|||||TWO_SIDED|95.0|-1.4|8.5|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.||8.5|-1.4|
74093184|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.12||0.3095|TWO_SIDED|95.0|-1.1|3.3|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 28||3.3|-1.1|0.3095
74093185|NCT04442490|147737991|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.17||0.1477|TWO_SIDED|95.0|-0.6|4.0|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 42||4.0|-0.6|0.1477
74093186|NCT04442490|147737992|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.57||0.0828|TWO_SIDED|95.0|-2.1|0.1|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 8||0.1|-2.1|0.0828
74010689|NCT01798589|147572591|OTHER|Bioequivalence is assessed based on concordance between the 2 allergen using Kappa statistic|Concordance|66.7|||||TWO_SIDED|95.0|41.6|90.2||||||||90.2|41.6|
74010690|NCT00307151|147572611|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.6||||0.015|TWO_SIDED|95.0|3.7|33.6||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (\<12 months vs. \>=12 months)and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.|||33.6|3.7|0.015
74041296|NCT01170221|147634525|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.7|||||TWO_SIDED|95.0|-2.8|6.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.||6.4|-2.8|
74041297|NCT01488409|147634541|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||||||0.97
74041298|NCT01488409|147634542|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
74041299|NCT01488409|147634543|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||t-test, 2 sided|||||||0.52
74041300|NCT01488409|147634544|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
74041301|NCT01488409|147634545|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||||||0.007
74041302|NCT03796182|147634562|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|98.5|||||TWO_SIDED|90.0|82.09|118.2||||||||118.20|82.09|
74041303|NCT03796182|147634563|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|93.49|||||TWO_SIDED|90.0|85.15|102.65||||||||102.65|85.15|
74041304|NCT03796182|147634564|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|88.07|||||TWO_SIDED|90.0|80.99|95.76||||||||95.76|80.99|
74041305|NCT03796182|147634566|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|94.25|||||TWO_SIDED|90.0|88.19|100.73||||||||100.73|88.19|
74041306|NCT04682353|147634576|OTHER||Geometric Mean Ratio|0.976|||||TWO_SIDED|90.0|0.748|1.274||||||||1.274|0.748|
74041307|NCT04682353|147634576|OTHER||Geometric Mean Ratio|1.226|||||TWO_SIDED|90.0|0.94|1.598||||||||1.598|0.940|
74041308|NCT04682353|147634576|OTHER||Geometric Mean Ratio|1.817|||||TWO_SIDED|90.0|1.38|2.392||||||||2.392|1.380|
74041309|NCT04682353|147634578|OTHER||Geometric Mean Ratio|1.202|||||TWO_SIDED|90.0|0.96|1.506||||||||1.506|0.960|
74041310|NCT04682353|147634578|OTHER||Geometric Mean Ratio|1.393|||||TWO_SIDED|90.0|1.07|1.815||||||||1.815|1.070|
74041311|NCT04682353|147634578|OTHER||Geometric Mean Ratio|2.301|||||TWO_SIDED|90.0|1.806|2.933||||||||2.933|1.806|
74041312|NCT04682353|147634579|OTHER||Geometric Mean Ratio|1.699|||||TWO_SIDED|90.0|0.921|3.135||||||||3.135|0.921|
74041313|NCT04682353|147634579|OTHER||Geometric Mean Ratio|2.364|||||TWO_SIDED|90.0|1.273|4.39||||||||4.390|1.273|
74041314|NCT04682353|147634579|OTHER||Geometric Mean Ratio|3.748|||||TWO_SIDED|90.0|2.033|6.908||||||||6.908|2.033|
74041315|NCT04682353|147634580|OTHER||Geometric Mean Ratio|1.904|||||TWO_SIDED|90.0|0.886|4.093||||||||4.093|0.886|
74093187|NCT04442490|147737992|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62||0.0606|TWO_SIDED|95.0|-2.4|0.1|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 15||0.1|-2.4|0.0606
74093188|NCT04442490|147737992|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.63||0.1079|TWO_SIDED|95.0|-2.3|0.2|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 28||0.2|-2.3|0.1079
74093189|NCT04442490|147737992|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.66||0.3951|TWO_SIDED|95.0|-1.9|0.7|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 42||0.7|-1.9|0.3951
74093190|NCT02227147|147737993|SUPERIORITY||Difference in percentage|40.4|||=|0.006|TWO_SIDED|90.0|14.2|66.6|||Chi-squared|||||66.6|14.2|=0.006
74041316|NCT04682353|147634580|OTHER||Geometric Mean Ratio|3.317|||||TWO_SIDED|90.0|1.585|6.942||||||||6.942|1.585|
74010691|NCT00307151|147572611|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.5|||<|0.001|TWO_SIDED|95.0|11.2|31.8||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (\<12 months vs. \>=12 months) and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.|||31.8|11.2|<0.001
74010692|NCT03600142|147572645|NON_INFERIORITY|For WLHIV (n=55), chi-square tests were used to assess differences between conditions in the proportion of participants who were retained in HIV care at 3 months post enrollment.||||||0.963|||||||Chi-squared|||We were aware that our resources of time and funding would not be sufficient to detect a significant difference in the HIV care outcome, and that we would only be able to detect observational signals of impact. We aimed for a minimum of 50 WLHIV, which is considered an adequate sample to assess feasibility and acceptability in a pilot intervention study. Given an estimated 5% HIV prevalence among women presenting for ANC, this required us to enroll 1000 female participants.||||0.963
74010693|NCT01180478|147572658|SUPERIORITY_OR_OTHER|||||||0.585|||||||Log Rank|||The expected recurrence rate in the WL-assisted TURBT group was 35%.14 To detect a clinically relevant difference in recurrence detection rates ≥10% at a 5% significance level and a power of 80%, the required sample size per treatment was calculated to be 329 patients (658 patients in total).||||0.585
74010694|NCT01180478|147572659|SUPERIORITY_OR_OTHER|||||||0.742|||||||Chi-squared|||||||0.742
74010695|NCT01180478|147572660|SUPERIORITY_OR_OTHER|||||||0.17|||||||Fisher Exact|The analysis was performed by using the Fisher exact test, because the criteria for using the Chi square test were not met.||The statistical analyses refers to comparison of the different 8 categories (one variable) mentioned of the Clavien grading of perioperative complications between Narrow Band Imaging and White Light Trans Urethral Resection.||||0.170
74010696|NCT01180478|147572661|SUPERIORITY_OR_OTHER|||||||0.311|||||||Chi-squared|||Comparison of the numbers in 'Bleeding' between NBI and WL||||0.311
74010697|NCT01180478|147572661|SUPERIORITY_OR_OTHER|||||||0.666|||||||Chi-squared|||Comparison of the numbers in 'Fever' between NBI and WL||||0.666
74010698|NCT01180478|147572661|SUPERIORITY_OR_OTHER|||||||0.569|||||||Chi-squared|||Comparison in the number of 'UTI' between NBI and WL||||0.569
74010699|NCT01180478|147572661|SUPERIORITY_OR_OTHER|||||||0.111|||||||Chi-squared|||Comparison in the number of 'Bladder cramps' between NBI and WL||||0.111
74010700|NCT01180478|147572661|SUPERIORITY_OR_OTHER|||||||||||||||||Comparison in the number of 'DVT' between NBI and WL|Non of the participants/patients had DVT. Therefore, the p-value is not available|||
74010701|NCT01180478|147572661|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'CVA/TIA' between NBI and WL||||0.500
74010702|NCT01180478|147572661|SUPERIORITY_OR_OTHER|||||||||||||||||Comparison in the number of 'Lung embolism' between NBI and WL|Non of the participants/patients had a lung embolism. Therefore, no p-value was available|||
74010703|NCT01180478|147572661|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'Sepsis' between NBI and WL||||0.500
74010704|NCT01180478|147572661|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Comparison in the number of 'Acute Abdomen' between NBI and WL||||1.000
74010705|NCT01180478|147572661|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||Comparison in the number of 'Other perioperative complication' between NBI and WL||||0.170
74010706|NCT01180478|147572662|SUPERIORITY_OR_OTHER|||||||0.553|TWO_SIDED||||||Chi-squared|||||||0.553
74010707|NCT00054704|147572663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.828|STANDARD_ERROR_OF_MEAN|3.182||0.086|TWO_SIDED|95.0|-12.59|0.934||A linear mixed model included drug, visit and their interaction as fixed factors. Subject was a random factor. The test here is for the main effect of drug.|Mixed Models Analysis|Baseline score was a covariate. Restricted maximum likelihood estimates were used with a compound symmetry covariance structure.||The primary intent of this study was to compare the efficacy of riluzole to placebo in the treatment of overall depressive symptomatology of bipolar disorder subjects who were acutely depressed. Data from 8 riluzole and 11 placebo participants were analyzed due to missing data for one riluzole patient.||0.934|-12.590|.086
74010708|NCT01469182|147572687|SUPERIORITY_OR_OTHER||Percent Difference|9.95||||0.005|TWO_SIDED|95.0|3.1|16.7|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||16.7|3.1|0.005
74010709|NCT01469182|147572688|SUPERIORITY_OR_OTHER||Percent Difference|5.58|||<|0.001|TWO_SIDED|95.0|2.9|8.2|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||8.2|2.9|<0.001
74010710|NCT01469182|147572689|SUPERIORITY_OR_OTHER||Percent Difference|7.88|||<|0.001|TWO_SIDED|95.0|5.5|10.5|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||10.5|5.5|<0.001
74010711|NCT01469182|147572690|SUPERIORITY_OR_OTHER||Percent Difference|10.17|||<|0.001|TWO_SIDED|95.0|6.6|13.6|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||13.6|6.6|<0.001
74010712|NCT01469182|147572691|SUPERIORITY_OR_OTHER||Percent Difference|5.25|||<|0.001|TWO_SIDED|95.0|3.3|7.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||7.4|3.3|<0.001
74041317|NCT04682353|147634580|OTHER||Geometric Mean Ratio|5.824|||||TWO_SIDED|90.0|2.796|12.135||||||||12.135|2.796|
74041318|NCT04682353|147634581|OTHER||Geometric Mean Ratio|1.095|||||TWO_SIDED|90.0|0.92|1.302||||||||1.302|0.920|
74041319|NCT04682353|147634581|OTHER||Geometric Mean Ratio|1.415|||||TWO_SIDED|90.0|1.148|1.744||||||||1.744|1.148|
74041320|NCT04682353|147634581|OTHER||Geometric Mean Ratio|2.017|||||TWO_SIDED|90.0|1.692|2.405||||||||2.405|1.692|
74041321|NCT04682353|147634582|OTHER||Geometric Mean Ratio|1.112|||||TWO_SIDED|90.0|0.948|1.303||||||||1.303|0.948|
74041322|NCT04682353|147634582|OTHER||Geometric Mean Ratio|1.439|||||TWO_SIDED|90.0|1.174|1.762||||||||1.762|1.174|
74041323|NCT04682353|147634582|OTHER||Geometric Mean Ratio|2.075|||||TWO_SIDED|90.0|1.751|2.459||||||||2.459|1.751|
74010713|NCT01469182|147572692|SUPERIORITY_OR_OTHER||Percent Difference|0.17||||0.861|TWO_SIDED|95.0|-2.1|1.9|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||1.9|-2.1|0.861
74010714|NCT01469182|147572693|SUPERIORITY_OR_OTHER||Percent Difference|1.15||||0.344||95.0|-1.5|3.3|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||3.3|-1.5|0.344
74010715|NCT01469182|147572694|SUPERIORITY_OR_OTHER||Percent Difference|0.99||||0.382|TWO_SIDED|95.0|-1.5|3.0|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||3.0|-1.5|0.382
74010716|NCT01469182|147572695|SUPERIORITY_OR_OTHER||Percent Difference|2.46||||0.029|TWO_SIDED|95.0|0.3|4.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||4.4|0.3|0.029
74010717|NCT02687542|147572707|OTHER|Bayesian Dose Response Analysis|Bayesian Dose Reponse Estimate|-0.693|STANDARD_ERROR_OF_MEAN|0.6162||0.5776|TWO_SIDED|90.0|-1.713|0.304||Bayesian Predictive Test for Emax (the additive increase over Placebo in the response of PF-06649751 at a theoretically infinite dose) Monotonicity|Bayesian Dose Response Analysis|Estimate and 90% credible interval of Bayesian dose response difference from placebo||||0.304|-1.713|0.5776
74041324|NCT04682353|147634583|OTHER||Geometric Mean Ratio|1.115|||||TWO_SIDED|90.0|0.993|1.252||||||||1.252|0.993|
74041325|NCT04682353|147634583|OTHER||Geometric Mean Ratio|1.53|||||TWO_SIDED|90.0|1.277|1.833||||||||1.833|1.277|
74041326|NCT04682353|147634583|OTHER||Geometric Mean Ratio|2.14|||||TWO_SIDED|90.0|1.888|2.425||||||||2.425|1.888|
74041327|NCT00862654|147634605|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.||||<0.01
74041328|NCT00862654|147634605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.||||0.039
74041329|NCT03954444|147634611|EQUIVALENCE|90% Confidence Interval, should be within -20% to +20%|Mean Difference (Net)|2.7|||||TWO_SIDED|90.0|-2.6|8.0||||||||8.0|-2.6|
74010718|NCT02114164|147572720|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74010719|NCT02114164|147572721|OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
74010720|NCT02114164|147572722|OTHER|||||||0.13||||||Comparison at baseline|t-test, 2 sided|||||||0.13
74010721|NCT02114164|147572722|OTHER|||||||0.018||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.018
74010722|NCT02114164|147572722|OTHER|||||||0.712||||||Comparison at end of procedure|t-test, 2 sided|||||||0.712
74010723|NCT02114164|147572723|OTHER|||||||0.42||||||Comparison at baseline|t-test, 2 sided|||||||0.42
74010724|NCT02114164|147572723|OTHER|||||||0.75||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.75
74010725|NCT02114164|147572723|OTHER|||||||0.99||||||Comparison at end of procedure|t-test, 2 sided|||||||0.99
74010726|NCT02114164|147572724|OTHER|||||||0.88||||||Comparison at baseline|t-test, 2 sided|||||||0.88
74010727|NCT02114164|147572724|OTHER|||||||0.65||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.65
74010728|NCT02114164|147572724|OTHER|||||||0.86||||||Comparison at end of procedure|t-test, 2 sided|||||||0.86
74010729|NCT02114164|147572725|OTHER|Number of interventions required by the anesthesiologists were compared between the AirSeal and standard Endopath groups using zero-inflated Poisson regression||||||0.41|||||||Zero-inflated Poisson regression|||||||0.41
74010730|NCT02114164|147572726|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
74010731|NCT02114164|147572727|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
74010732|NCT02187471|147572841|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.4601|TWO_SIDED|95.0|-0.52|0.23|||Difference of means|||||0.23|-0.52|0.4601
74041330|NCT03954444|147634611|SUPERIORITY|||||||0.04|||||||Cochran-Mantel-Haenszel|||||||0.04
74041331|NCT03954444|147634611|SUPERIORITY|||||||0.1126|||||||Cochran-Mantel-Haenszel|||||||0.1126
74041332|NCT05064332|147634656|OTHER||Ratio of Adjusted Geometric Means|101.43|||||TWO_SIDED|90.0|93.01|110.61||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed AUClast was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.61|93.01|
74041333|NCT05064332|147634657|OTHER||Ratio of Adjusted Geometric Means|108.51|||||TWO_SIDED|90.0|98.85|119.11||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed AUClast was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||119.11|98.85|
74041334|NCT05064332|147634658|OTHER||Ratio of Adjusted Geometric Means|95.07|||||TWO_SIDED|90.0|84.44|107.04||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed Cmax was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.04|84.44|
74093191|NCT02227147|147737994|SUPERIORITY||Difference in percentage|36.1|||=|0.013|TWO_SIDED|95.0|9.4|62.7|||Chi-squared|||||62.7|9.4|=0.013
74093192|NCT02227147|147737995|SUPERIORITY||difference in percentage|19.0|||=|0.191|TWO_SIDED|95.0|-9.0|47.1|||Chi-squared|||week 4 - central reviewer||47.1|-9.0|=0.191
74093193|NCT02227147|147737995|SUPERIORITY||difference in percentage|10.7|||=|0.464|TWO_SIDED|95.0|-17.7|39.1|||Chi-squared|||week 6 - central reviewer||39.1|-17.7|=0.464
74093194|NCT02227147|147737995|SUPERIORITY||difference in percentage|14.9|||=|0.308|TWO_SIDED|95.0|-13.4|43.1|||Chi-squared|||week 4 - investigator||43.1|-13.4|=0.308
74093195|NCT02227147|147737995|SUPERIORITY||difference in percentage|23.6|||=|0.106|TWO_SIDED|95.0|-4.2|51.3|||Chi-squared|||week 6 - investigator||51.3|-4.2|=0.106
74093196|NCT02227147|147737996|SUPERIORITY||difference in percentage|9.5|||=|0.255|TWO_SIDED|95.0|-6.9|25.9|||Chi-squared|||week 4||25.9|-6.9|=0.255
73879466|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.98||0.0046|TWO_SIDED|95.0|-9.53|-1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.75|-9.53|0.0046
73879467|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.04||0.0064|TWO_SIDED|95.0|-9.61|-1.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.59|-9.61|0.0064
73879468|NCT03192176|147297613|SUPERIORITY||LSMean difference|-8.7|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-12.72|-4.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.65|-12.72|<0.0001
74010733|NCT02187471|147572841|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.77|-0.03|||Difference of means|||||-0.03|-0.77|0.0350
74093197|NCT02227147|147737996|SUPERIORITY||difference in percentage|0.8|||=|0.927|TWO_SIDED|95.0|-15.6|17.1|||Chi-squared|||week 6||17.1|-15.6|=0.927
74093198|NCT02227147|147737996|SUPERIORITY||difference in percentage|18.6|||=|0.062|TWO_SIDED|95.0|-0.7|37.8|||Chi-squared|||week 8||37.8|-0.7|=0.062
74093199|NCT02227147|147737997|SUPERIORITY||difference in least square means|1.1|||=|0.745|TWO_SIDED|95.0|-5.6|7.7|||ANCOVA|||||7.7|-5.6|=0.745
74093200|NCT02227147|147737998|SUPERIORITY||difference in percentage|-3.8|||=|0.672|TWO_SIDED|95.0|-21.3|13.7|||Chi-squared|||week 4||13.7|-21.3|=0.672
74093201|NCT02227147|147737998|SUPERIORITY||difference in percentage|0.5|||=|0.955|TWO_SIDED|95.0|-18.5|19.6|||Chi-squared|||week 6||19.6|-18.5|=0.955
74093202|NCT02227147|147737998|SUPERIORITY||difference in percentage|-3.6|||=|0.727|TWO_SIDED|95.0|-23.9|16.7|||Chi-squared|||week 8||16.7|-23.9|=0.727
74093203|NCT02227147|147737999|SUPERIORITY||least square mean difference|0.6|||=|0.207|TWO_SIDED|95.0|-0.4|1.5|||ANCOVA|||||1.5|-0.4|=0.207
74093204|NCT02227147|147738000|SUPERIORITY||difference in percentage|-13.3|||=|0.11|TWO_SIDED|95.0|-30.5|3.9|||Chi-squared|||||3.9|-30.5|=0.110
74093205|NCT03514641|147738001|SUPERIORITY||LS Means difference|-2.72||||0.0025|TWO_SIDED|95.0|-4.47|-0.96|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.96|-4.47|0.0025
74093206|NCT03514641|147738002|SUPERIORITY||Mean Difference (Final Values)|-2.43||||0.0117|TWO_SIDED|95.0|-4.32|-0.54|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.54|-4.32|0.0117
74093207|NCT03514641|147738003|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1317|TWO_SIDED|95.0|0.92|1.83||Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP|Covariance|||||1.83|0.92|0.1317
74093208|NCT03514641|147738004|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0113|TWO_SIDED|95.0|1.11|2.3|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.30|1.11|0.0113
74093209|NCT03514641|147738005|SUPERIORITY||Mean Difference (Final Values)|-4.63|||<|0.0001|TWO_SIDED|95.0|-6.83|-2.42|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-2.42|-6.83|<0.0001
74093210|NCT03514641|147738006|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0004|TWO_SIDED|95.0|1.32|2.62|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.62|1.32|0.0004
74093211|NCT03514641|147738007|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.0863|TWO_SIDED|95.0|-1.79|0.12|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.12|-1.79|0.0863
74093212|NCT03514641|147738008|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0232|TWO_SIDED|95.0|1.06|2.08|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.08|1.06|0.0232
74093213|NCT03514641|147738009|SUPERIORITY||Odds Ratio (OR)|1.81||||0.014|TWO_SIDED|95.0|1.13|2.91|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.91|1.13|0.0140
74093214|NCT03514641|147738010|SUPERIORITY||Mean Difference (Final Values)|-2.31||||0.0011|TWO_SIDED|95.0|-3.7|-0.92|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.92|-3.70|0.0011
74093215|NCT03514641|147738011|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0094|TWO_SIDED|95.0|1.13|2.35|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.35|1.13|0.0094
74093216|NCT03514641|147738012|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.0083|TWO_SIDED|95.0|-5.57|-0.83|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.83|-5.57|0.0083
74093217|NCT03514641|147738013|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.1085|TWO_SIDED|95.0|-1.87|0.19|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.19|-1.87|0.1085
74093218|NCT03514641|147738014|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0837|TWO_SIDED|95.0|-2.67|0.17|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.17|-2.67|0.0837
74093219|NCT01055132|147738034|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve 80% power with 0.05 type I error.|Least-square mean difference|-0.037|STANDARD_ERROR_OF_MEAN|0.0072|||TWO_SIDED|95.0|-0.041|-0.0013|||linear mixed model|Sequence of wear, period and lens were included as fixed effects; site, patient, eye\*patient, period\*patient and period\*eye\*patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference(test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for monocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.||-0.0013|-0.041|
74093220|NCT01055132|147738035|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0062|||TWO_SIDED|95.0|-0.027|-0.003|||linear mixed model|Sequence of wear,lens period and lens were included in the model as fixed effects; site, patient, period\*patient were included as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for Binocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.||-0.003|-0.027|
74093221|NCT01055132|147738036|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|11.9|STANDARD_ERROR_OF_MEAN|3.93|||TWO_SIDED|95.0|4.05|19.79|||linear mixed model|Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and Site and patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for comfort at 1-week follow-up. A non-inferiority margin of -5 units was used.||19.79|4.05|
74093222|NCT01055132|147738037|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|least-square mean difference|7.7|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|0.58|14.8|||linear mixed model|Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and site and patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for overall quality of vision at 1-week follow-up. A non-inferiority margin of -5 units was used.||14.80|0.58|
74093223|NCT01156142|147738079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|||<|0.001|TWO_SIDED|95.0|-6.7|-2.1|||Wilcoxon (Mann-Whitney)|||||-2.1|-6.7|<0.001
74093224|NCT01156142|147738080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0018|TWO_SIDED|95.0|0.1|5.1|||Wilcoxon (Mann-Whitney)|||||5.1|0.1|0.0018
74093225|NCT01156142|147738081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6||||0.001|TWO_SIDED|95.0|2.9|8.3|||Wilcoxon (Mann-Whitney)|||||8.3|2.9|0.001
74093226|NCT01156142|147738082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.0297|TWO_SIDED|95.0|-1.2|4.6|||Wilcoxon (Mann-Whitney)|||||4.6|-1.2|0.0297
73879469|NCT03192176|147297613|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.78|-4.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.75|-12.78|<0.0001
74093227|NCT01156142|147738083|SUPERIORITY_OR_OTHER|||||||0.1392|||||||Chi-squared|||At 2 hours after initial mouthwash||||0.1392
74093228|NCT01156142|147738083|SUPERIORITY_OR_OTHER|||||||0.6989|||||||Chi-squared|||At 4 hours after initial mouthwash||||0.6989
74093229|NCT01156142|147738084|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Chi-squared|||||||0.0018
74093230|NCT02337959|147738126|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.028
74093231|NCT02337959|147738127|SUPERIORITY_OR_OTHER|||||||0||||||level of significance (alpha) = 0.05|t-test, 1 sided|||Both the predicate and investigational images were randomized for the monitors. Predicate images could display on the left or the right and vice versa with the investigational. There were formulas in the spreadsheet that gave the preferences a numerical value, and subsequently became part of the analysis.||||0.000
74093232|NCT04988152|147738138|SUPERIORITY||Ratio of geometric least squares means|1.0724|||||TWO_SIDED|90.0|0.8519|1.35|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||1.3500|0.8519|
74093233|NCT04988152|147738139|OTHER||Ratio of geometric least squares means|1.0513|||||TWO_SIDED|90.0|0.9281|1.1908|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUC(D1-29) as the dependent variable, and ethnicity and body weight were covariates.|||1.1908|0.9281|
74093234|NCT04988152|147738142|OTHER||Ratio of geometric least squares means|1.6999|||||TWO_SIDED|90.0|1.15|2.5129|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||2.5129|1.1500|
73879470|NCT03192176|147297613|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.27|-6.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-6.09|-14.27|<0.0001
74093235|NCT04988152|147738143|OTHER||Ratio of geometric least squares means|1.5869|||||TWO_SIDED|90.0|1.1236|2.2413|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUC(D1-29) as the dependent variable, and ethnicity and body weight were covariates.|||2.2413|1.1236|
74093236|NCT04988152|147738158|OTHER||Ratio of geometric least squares means|1.0724|||||TWO_SIDED|90.0|0.8519|1.35|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||1.3500|0.8519|
74093237|NCT04988152|147738160|OTHER||Ratio of geometric least squares means|1.0673|||||TWO_SIDED|90.0|0.9286|1.2268|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUClast as the dependent variable, and ethnicity and body weight were covariates.|||1.2268|0.9286|
74093238|NCT04988152|147738164|OTHER||Ratio of geometric least squares means|1.6999|||||TWO_SIDED|90.0|1.15|2.5129|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||2.5129|1.1500|
74093239|NCT04988152|147738166|OTHER||Ratio of geometric least squares means|1.5766|||||TWO_SIDED|90.0|1.1777|2.1106|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUClast as the dependent variable, and ethnicity and body weight were covariates|||2.1106|1.1777|
74093240|NCT00535587|147738183|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|2.94|<|0.02|TWO_SIDED|95.0|||||ANCOVA|||||||<0.02
74093241|NCT01355159|147738214|SUPERIORITY||Risk Ratio (RR)|1.1||||0.37|TWO_SIDED|95.0|0.9|1.34|||Chi-squared|||||1.34|0.90|0.37
74093242|NCT01355159|147738216|SUPERIORITY||Risk Ratio (RR)|1.29||||0.37|TWO_SIDED|95.0|0.74|2.28|||Chi-squared|||||2.28|0.74|0.37
74093243|NCT01355159|147738217|SUPERIORITY||Risk Ratio (RR)|0.64||||0.21|TWO_SIDED|95.0|0.31|1.31|||Chi-squared|||||1.31|0.31|0.21
74093244|NCT01355159|147738218|SUPERIORITY||Risk Ratio (RR)|0.97||||0.71|TWO_SIDED|95.0|0.82|1.15|||Chi-squared|||||1.15|0.82|0.71
74093245|NCT01355159|147738219|SUPERIORITY||Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.86|1.13|||Chi-squared|||||1.13|0.86|0.87
74093246|NCT01355159|147738220|SUPERIORITY||Risk Ratio (RR)|1.21||||0.75|TWO_SIDED|95.0|0.37|3.96|||Chi-squared|||||3.96|0.37|0.75
74093247|NCT01355159|147738221|SUPERIORITY||Risk Ratio (RR)|1.52||||0.19|TWO_SIDED|95.0|0.81|2.84|||Chi-squared|||||2.84|0.81|0.19
74093248|NCT01355159|147738222|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|7.0||0.61|TWO_SIDED|95.0|-0.96|1.63|||t-test, 2 sided|||||1.63|-0.96|0.61
74093249|NCT01355159|147738223|SUPERIORITY||Risk Ratio (RR)|0.6||||0.14|TWO_SIDED|95.0|0.3|1.19|||Chi-squared|||||1.19|0.30|0.14
74093250|NCT01355159|147738224|SUPERIORITY||Risk Ratio (RR)|0.76||||0.37|TWO_SIDED|95.0|0.41|1.39|||Chi-squared|||||1.39|0.41|0.37
74093251|NCT01355159|147738225|SUPERIORITY||Risk Ratio (RR)|1.03||||0.82|TWO_SIDED|95.0|0.81|1.3|||Chi-squared|||||1.30|0.81|0.82
74093252|NCT01355159|147738226|SUPERIORITY||Risk Ratio (RR)|0.87||||0.79|TWO_SIDED|95.0|0.31|2.44|||Chi-squared|||||2.44|0.31|0.79
74093253|NCT01355159|147738227|SUPERIORITY||Risk Ratio (RR)|0.63||||0.07|TWO_SIDED|95.0|0.37|1.05|||Chi-squared|||||1.05|0.37|0.07
74093254|NCT01355159|147738228|SUPERIORITY||Risk Ratio (RR)|1.2||||0.65|TWO_SIDED|95.0|0.54|2.66|||Chi-squared|||||2.66|0.54|0.65
74093255|NCT01355159|147738229|SUPERIORITY||Risk Ratio (RR)|0.34||||0.1|TWO_SIDED|95.0|0.09|1.23|||Chi-squared|||||1.23|0.09|0.10
74093256|NCT01355159|147738230|SUPERIORITY||Risk Ratio (RR)|2.04||||0.33|TWO_SIDED|95.0|0.49|8.57|||Chi-squared|||||8.57|0.49|0.33
73887974|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|209.3|||<|0.0001|TWO_SIDED|95.0|108.3|310.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||310.3|108.3|<0.0001
74093257|NCT01355159|147738231|SUPERIORITY||Risk Ratio (RR)|0.97||||0.94|TWO_SIDED|95.0|0.47|2.0|||Chi-squared|||||2.00|0.47|0.94
74093258|NCT01355159|147738232|SUPERIORITY||Risk Ratio (RR)|1.61||||0.06|TWO_SIDED|95.0|0.97|2.66|||Chi-squared|||||2.66|0.97|0.06
74093259|NCT01355159|147738233|SUPERIORITY||Risk Ratio (RR)|2.37||||0.21|TWO_SIDED|95.0|0.61|9.14|||Chi-squared|||||9.14|0.61|0.21
74093260|NCT01355159|147738234|SUPERIORITY||Risk Ratio (RR)|1.2||||0.38|TWO_SIDED|95.0|0.8|1.8|||Chi-squared|||||1.80|0.80|0.38
74093261|NCT01355159|147738235|SUPERIORITY||Mean Difference (Net)|-1.6||||46|TWO_SIDED|95.0|-5.84|2.64|||t-test, 2 sided|||||2.64|-5.84|046
74093262|NCT01355159|147738236|SUPERIORITY||Risk Ratio (RR)|0.87||||0.79|TWO_SIDED|95.0|0.31|2.44|||Chi-squared|||||2.44|0.31|0.79
74093263|NCT01355159|147738237|SUPERIORITY||Risk Ratio (RR)|2.0||||0.42|TWO_SIDED|95.0|0.37|10.92|||Chi-squared|||||10.92|0.37|0.42
74093264|NCT01194973|147738244|SUPERIORITY_OR_OTHER||LS mean change from baseline|117.68|||<|0.0001|TWO_SIDED|95.0|92.77|142.59|||ANOVA|||||142.59|92.77|<0.0001
74093265|NCT01194973|147738250|SUPERIORITY_OR_OTHER||LS mean change from baseline|102.49|||<|0.0001|TWO_SIDED|95.0|68.15|136.82|||ANOVA|||||136.82|68.15|<0.0001
74093266|NCT04700280|147738313|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|2.69||0.617|TWO_SIDED|90.0|-6.2|3.4|||Mixed Models Analysis|||||3.4|-6.2|0.617
74093267|NCT04700280|147738315|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.62||0.3089|TWO_SIDED|90.0|-1.7|0.41|||Mixed Models Analysis|||Week 4||0.41|-1.70|0.3089
74093268|NCT04700280|147738315|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.71||0.2834|TWO_SIDED|90.0|-1.97|0.43|||Mixed Models Analysis|||Week 8||0.43|-1.97|0.2834
74093269|NCT04700280|147738315|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.95||0.7109|TWO_SIDED|90.0|-2.02|1.3|||Mixed Models Analysis|||Week 12||1.30|-2.02|0.7109
74093270|NCT04700280|147738316|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.81||0.859|TWO_SIDED|90.0|-3.6|2.9|||Mixed Models Analysis|||Week 4||2.9|-3.6|0.859
74093271|NCT04700280|147738316|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.46||0.837|TWO_SIDED|90.0|-3.8|4.8|||Mixed Models Analysis|||Week 8||4.8|-3.8|0.837
74093272|NCT02615171|147738319|OTHER|||||||0.0106|||||||t-test, 2 sided|||||||0.0106
73879471|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|2.08||0.0021|TWO_SIDED|95.0|-10.54|-2.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.36|-10.54|0.0021
73879472|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|2.05||0.0002|TWO_SIDED|95.0|-11.71|-3.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-3.66|-11.71|0.0002
73879473|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|2.04||0.0007|TWO_SIDED|95.0|-10.96|-2.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.95|-10.96|0.0007
73879474|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.5|STANDARD_ERROR_OF_MEAN|2.03||0.0075|TWO_SIDED|95.0|-9.46|-1.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.47|-9.46|0.0075
73879475|NCT03192176|147297613|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.44|-4.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.42|-12.44|<0.0001
73879476|NCT03192176|147297613|SUPERIORITY||LSMean difference|-8.2|STANDARD_ERROR_OF_MEAN|2.03|<|0.0001|TWO_SIDED|95.0|-12.15|-4.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.16|-12.15|<0.0001
73879477|NCT03192176|147297613|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.07|<|0.0001|TWO_SIDED|95.0|-14.3|-6.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-6.16|-14.30|<0.0001
73879478|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|2.06||0.0021|TWO_SIDED|95.0|-10.46|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.34|-10.46|0.0021
73879479|NCT03192176|147297613|SUPERIORITY||LSMean difference|-8.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-12.25|-4.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.25|-12.25|<0.0001
73879480|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.02||0.0002|TWO_SIDED|95.0|-11.58|-3.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.62|-11.58|0.0002
74093273|NCT02615171|147738320|OTHER|||||||0.0027|||||||Chi-squared|||||||0.0027
74093274|NCT02615171|147738321|OTHER|||||||0.7829|||||||Wilcoxon rank sum test|||||||0.7829
74093275|NCT00888459|147738332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||Chi-squared|||||||.432
74093276|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.11|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||0.09|-0.11|
74093277|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||TWO_SIDED|95.0|-0.38|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.17|-0.38|
74093278|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||TWO_SIDED|95.0|-0.37|-0.16|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.16|-0.37|
74093279|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.3|||||TWO_SIDED|95.0|0.13|0.46|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.46|0.13|
74093280|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.13|||||TWO_SIDED|95.0|-0.04|0.29|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.29|-0.04|
74041335|NCT05064332|147634659|OTHER||Ratio of Adjusted Geometric Means|117.99|||||TWO_SIDED|90.0|101.82|136.73||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed Cmax was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||136.73|101.82|
74041336|NCT02293902|147634669|SUPERIORITY||Odds Ratio (OR)|12.185|||<|0.0001|TWO_SIDED|95.0|5.583|26.594||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by prior biologic use (Yes, No) and weight at screening (\<55 kg, \>=55 kg).|Placebo vs. Sarilumab 150 mg|26.594|5.583|<0.0001
74041337|NCT02293902|147634669|SUPERIORITY||Odds Ratio (OR)|7.227|||<|0.0001|TWO_SIDED|95.0|3.446|15.158||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using CMH test stratified by prior biologic use (Yes, No) and weight at screening (\<55 kg, \>=55 kg).|Placebo vs. Sarilumab 200 mg|15.158|3.446|<0.0001
74041338|NCT05742841|147634685|SUPERIORITY||Median Difference (Final Values)|-16.5|||||TWO_SIDED|||||||||||||
74041339|NCT04134728|147634686|SUPERIORITY||Odds Ratio (OR)|1.38||||0.2868|TWO_SIDED|0.95|0.76|2.48|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from placebo in the proportion of participants with ACR20 response at Week 12||2.48|0.76|0.2868
74041340|NCT04134728|147634686|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0596|TWO_SIDED|0.95|0.98|3.15|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and placebo in the percentage of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from placebo in the percentage of participants with ACR20 response at Week 12||3.15|0.98|0.0596
74041341|NCT04134728|147634686|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0049|TWO_SIDED|0.95|1.29|4.23|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 200 mg dose of Sarilumab alternating with placebo every week and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 200 mg dose of Sarilumab alternating with placebo every week differs from placebo in the proportion of participants with ACR20 response at Week 12||4.23|1.29|0.0049
74041342|NCT04134728|147634686|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0293|TWO_SIDED|0.95|0.36|0.95|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12||0.95|0.36|0.0293
74041343|NCT04134728|147634686|SUPERIORITY||Odds Ratio (OR)|0.75||||0.2308|TWO_SIDED|0.95|0.47|1.2|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12||1.20|0.47|0.2308
74093281|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.17|||||TWO_SIDED|95.0|-0.33|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||-0.01|-0.33|
74093282|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.04|-0.16|
74093283|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.04|-0.16|
74093284|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.10|-0.10|
74093285|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.15|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.09|-0.15|
74093286|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.16|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.08|-0.16|
74093287|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.11|-0.13|
74093288|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.13|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.07|-0.13|
74093289|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.13|||||TWO_SIDED|95.0|-0.23|-0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.03|-0.23|
74093290|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.1|||||TWO_SIDED|95.0|-0.2|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.00|-0.20|
74093291|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||TWO_SIDED|95.0|-0.22|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.01|-0.22|
74093292|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.34|||||TWO_SIDED|95.0|-0.44|-0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.23|-0.44|
74093293|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.22|||||TWO_SIDED|95.0|-0.33|-0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.11|-0.33|
74010734|NCT02187471|147572841|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.191||0.0001|TWO_SIDED|95.0|-1.12|-0.37|||Difference of means|||||-0.37|-1.12|0.0001
74041344|NCT05355818|147634832|SUPERIORITY||Diff. in proportion of responders in %|37.9|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian|Historical information from LP0133-1401 (NCT04871711)/LP0133-1402 (NCT04872101) as prior information is used.|There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 13.5% to 58.2%.|Based on the primary estimand 'composite'. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
74041345|NCT05355818|147634833|SUPERIORITY||Diff. in proportion of responders in %|36.4|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 12.3% to 59.9%.|Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
74010735|NCT02187471|147572841|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.193||0.0019|TWO_SIDED|95.0|0.22|0.98|||Difference of means|||||0.98|0.22|0.0019
74010736|NCT02187471|147572841|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.192||0.0761|TWO_SIDED|95.0|-0.04|0.72|||Difference of means|||||0.72|-0.04|0.0761
74010737|NCT02187471|147572843|SUPERIORITY||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|1.67||0.3407|TWO_SIDED|95.0|-4.86|1.68|||Difference of means|||||1.68|-4.86|0.3407
74010738|NCT02187471|147572843|SUPERIORITY||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.669||0.0012|TWO_SIDED|95.0|-8.69|-2.15|||Difference of means|||||-2.15|-8.69|0.0012
74010739|NCT02187471|147572843|SUPERIORITY||Mean Difference (Final Values)|-4.39|STANDARD_ERROR_OF_MEAN|1.665||0.0083|TWO_SIDED|95.0|-7.66|-1.13|||Difference of means|||||-1.13|-7.66|0.0083
74010740|NCT02187471|147572843|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|1.677||0.0946|TWO_SIDED|95.0|-0.48|6.09|||Difference of means|||||6.09|-0.48|0.0946
74010741|NCT02187471|147572843|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|1.669||0.5384|TWO_SIDED|95.0|-4.3|2.24|||Difference of means|||||2.24|-4.30|0.5384
74010742|NCT02187471|147572845|SUPERIORITY||Difference in least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.003|TWO_SIDED|95.0|-1.5|-0.3|||ANCOVA|||||-0.3|-1.5|0.0030
74010743|NCT02187471|147572845|SUPERIORITY||Difference in least squares means|-1.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||ANCOVA|||||-1.1|-2.3|<0.0001
74010744|NCT02187471|147572845|SUPERIORITY||Difference in least squares means|-1.2|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|95.0|-1.7|-0.6|||ANCOVA|||||-0.6|-1.7|0.0001
74010745|NCT02187471|147572845|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3562|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.3562
74010746|NCT02187471|147572845|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0862|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA|||||0.1|-1.1|0.0862
74010747|NCT02187471|147572846|SUPERIORITY||Difference in least square means|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5183|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.4|-0.7|0.5183
74010748|NCT02187471|147572846|SUPERIORITY||Difference in least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2669|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.2|-0.9|0.2669
74010749|NCT02187471|147572846|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.463|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||0.3|-0.8|0.4630
74010750|NCT02187471|147572846|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.928|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.5|0.9280
74010751|NCT02187471|147572846|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7089|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.7|0.7089
74010752|NCT02187471|147572846|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.0669|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0|-1.1|0.0669
74010753|NCT02187471|147572846|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.28||0.0081|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||-0.2|-1.3|0.0081
74010754|NCT02187471|147572846|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.0867|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||0.1|-1.0|0.0867
74010755|NCT02187471|147572846|SUPERIORITY||Difference of least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.9066|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.6|0.9066
74010756|NCT02187471|147572846|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.3509|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.3|-0.8|0.3509
74010757|NCT02187471|147572847|SUPERIORITY||Difference in least squares means|2.187|STANDARD_ERROR_OF_MEAN|0.6203||0.0004|TWO_SIDED|95.0|0.97|3.404|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||3.404|0.970|0.0004
74010758|NCT02187471|147572847|SUPERIORITY||Difference of least squares means|2.483|STANDARD_ERROR_OF_MEAN|0.6209|<|0.0001|TWO_SIDED|95.0|1.265|3.701|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||3.701|1.265|<0.0001
74010759|NCT02187471|147572847|SUPERIORITY||Difference in least squares means|2.621|STANDARD_ERROR_OF_MEAN|0.6215|<|0.0001|TWO_SIDED|95.0|1.401|3.84|||ANCOVA|||Physical Component: Placebo vs Pregabalin 150 mg BID||3.840|1.401|<0.0001
74010760|NCT02187471|147572847|SUPERIORITY||Difference in least squares means|-0.434|STANDARD_ERROR_OF_MEAN|0.6245||0.4877|TWO_SIDED|95.0|-1.659|0.792|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.792|-1.659|0.4877
73879481|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.92||0.0123|TWO_SIDED|95.0|-8.6|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.05|-8.60|0.0123
73879482|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.92|<|0.0001|TWO_SIDED|95.0|-11.63|-4.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.07|-11.63|<0.0001
73879483|NCT03192176|147297613|SUPERIORITY||LSMean difference|-8.0|STANDARD_ERROR_OF_MEAN|1.92|<|0.0001|TWO_SIDED|95.0|-11.8|-4.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.23|-11.80|<0.0001
73879484|NCT03192176|147297613|SUPERIORITY||LSMean difference|-9.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-13.73|-6.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-6.03|-13.73|<0.0001
73879485|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.95||0.0013|TWO_SIDED|95.0|-10.13|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.47|-10.13|0.0013
73879486|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.92||0.0002|TWO_SIDED|95.0|-10.97|-3.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-3.41|-10.97|0.0002
73879487|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.91||0.0006|TWO_SIDED|95.0|-10.41|-2.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.89|-10.41|0.0006
73879488|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.9||0.0119|TWO_SIDED|95.0|-8.54|-1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.07|-8.54|0.0119
74093294|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.16|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.11|-0.16|
73879489|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.9||0.0004|TWO_SIDED|95.0|-10.58|-3.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.09|-10.58|0.0004
73879490|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-11.57|-4.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-4.06|-11.57|<0.0001
74010761|NCT02187471|147572847|SUPERIORITY||Difference in least squares means|-0.137|STANDARD_ERROR_OF_MEAN|0.6252||0.8263|TWO_SIDED|95.0|-1.364|1.089|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.089|-1.364|0.8263
74093295|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.18|||||TWO_SIDED|95.0|0.04|0.31|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.31|0.04|
73879491|NCT03192176|147297613|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.94|<|0.0001|TWO_SIDED|95.0|-12.89|-5.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-5.27|-12.89|<0.0001
73879492|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.93||0.0057|TWO_SIDED|95.0|-9.18|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.58|-9.18|0.0057
73879493|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.91||0.0006|TWO_SIDED|95.0|-10.4|-2.9||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.90|-10.40|0.0006
74010762|NCT02187471|147572847|SUPERIORITY||Difference in least squares means|0.228|STANDARD_ERROR_OF_MEAN|0.7345||0.7567|TWO_SIDED|95.0|-1.213|1.669|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.669|-1.213|0.7567
74010763|NCT02187471|147572847|SUPERIORITY||Difference in least squares means|0.7349|STANDARD_ERROR_OF_MEAN|0.7349||0.0787|TWO_SIDED|95.0|-0.149|2.735|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||2.735|-0.149|0.0787
74093296|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.2|||||TWO_SIDED|95.0|0.07|0.34|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.34|0.07|
74093297|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||TWO_SIDED|95.0|-0.23|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.01|-0.23|
74093298|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.16|||||TWO_SIDED|95.0|-0.28|-0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||-0.04|-0.28|
74093299|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.17|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.06|-0.17|
74093300|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.02|-0.19|
74093301|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.18|||||TWO_SIDED|95.0|-0.28|-0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||-0.07|-0.28|
74093302|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.02|-0.19|
74093303|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.25|||||TWO_SIDED|95.0|0.13|0.37|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.37|0.13|
74093304|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||TWO_SIDED|95.0|-0.12|0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.12|-0.12|
74093305|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.25|||||TWO_SIDED|95.0|-0.37|-0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||-0.13|-0.37|
74093306|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.14|||||TWO_SIDED|95.0|0.02|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.25|0.02|
73887975|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|145.7||||0.005|TWO_SIDED|95.0|44.7|246.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.6|44.7|0.0050
74093307|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.12|||||TWO_SIDED|95.0|0.01|0.24|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.24|0.01|
74093308|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.11|-0.13|
74093309|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.01|||||TWO_SIDED|95.0|-0.09|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.10|-0.09|
74093310|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.14|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.04|-0.14|
73887976|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|200.7||||0.0001|TWO_SIDED|95.0|99.7|301.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||301.6|99.7|0.0001
74041346|NCT05355818|147634834|SUPERIORITY||Diff. in proportion of responders in %|31.7|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 5.6% to 51.1%.|||||
74041347|NCT05355818|147634835|SUPERIORITY||Diff. in proportion of responders in %|31.2|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 8.7% to 49.4%|||||
74041348|NCT05355818|147634836|SUPERIORITY||Diff. in proportion of responders in %|25.1|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 3.9% to 42.3%.|Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
74041349|NCT05355818|147634837|SUPERIORITY||Risk Difference (RD)|17.47||||0.0054|TWO_SIDED|95.0|5.16|29.78|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||29.78|5.16|0.0054
74041350|NCT05355818|147634838|SUPERIORITY||Risk Difference (RD)|21.21||||0.0248|TWO_SIDED|95.0|2.69|39.72|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||39.72|2.69|0.0248
74041351|NCT05355818|147634839|SUPERIORITY||Risk Difference (RD)|11.08||||0.332|TWO_SIDED|95.0|-11.3|33.46|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||33.46|-11.30|0.3320
74041352|NCT05355818|147634840|SUPERIORITY||Risk Difference (RD)|33.02||||0.0016|TWO_SIDED|95.0|12.51|53.52|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||53.52|12.51|0.0016
74041353|NCT05355818|147634841|SUPERIORITY||Mean Difference (Net)|-2.65||||0.0038|TWO_SIDED|95.0|-4.42|-0.88|||ANCOVA|||Primary estimand: Composite. Data considered non-response by using WOCF (including the baseline value) after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed using WOCF (including the baseline value).||-0.88|-4.42|0.0038
74041354|NCT00092677|147634868|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.591||95.0|0.826|1.115|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.115|0.826|0.591
74041355|NCT00092677|147634869|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.973||||0.732||95.0|0.833|1.137|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.137|0.833|0.732
74041356|NCT00092677|147634870|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.024||95.0|0.628|0.967|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||0.967|0.628|0.024
74041357|NCT00092677|147634871|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.829||||0.344||95.0|0.563|1.222|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.222|0.563|0.344
73879494|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.89||0.0006|TWO_SIDED|95.0|-10.27|-2.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.81|-10.27|0.0006
74041358|NCT00092677|147634872|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.997||||0.968||95.0|0.842|1.179|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.179|0.842|0.968
74041359|NCT00092677|147634873|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.088||||0.771||95.0|0.617|1.917|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.917|0.617|0.771
74041360|NCT00092677|147634874|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.636||||0.147||95.0|0.345|1.173|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.173|0.345|0.147
74041361|NCT00092677|147634875|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.683||||0.015||95.0|0.503|0.929|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||0.929|0.503|0.015
74041362|NCT00092677|147634876|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.456||||||95.0|0.197|1.057||The p-value was not provided as there were less than 40 patients who reported the specific endpoint.|Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.057|0.197|
74041363|NCT00092677|147634877|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.608||||||95.0|0.199|1.86||The p-value was not provided as there were less than 40 patients who reported the specific endpoint.|Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.860|0.199|
74041364|NCT00092677|147634878|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.124||||0.647||95.0|0.682|1.85|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.850|0.682|0.647
74041365|NCT00092677|147634879|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.036||||0.799||95.0|0.788|1.363|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.363|0.788|0.799
74041366|NCT00092677|147634880|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.667||||0.052||95.0|0.996|2.791|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||2.791|0.996|0.052
74041367|NCT00092677|147634881|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.504||||0.008||95.0|1.111|2.035|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||2.035|1.111|0.008
74041368|NCT00092677|147634882|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.029||0.829||95.0|-0.063|0.051|||ANCOVA|Model terms: treatment and baseline peak transaortic jet velocity|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||0.051|-0.063|0.829
74041369|NCT00092677|147634883|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.1|STANDARD_ERROR_OF_MEAN|0.6|<=|0.001||95.0|-33.3|-31.0|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-31.0|-33.3|<=0.001
74041370|NCT00092677|147634884|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|0.9|<=|0.001||95.0|-51.8|-48.2|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-48.2|-51.8|<=0.001
74093311|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.15|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.04|-0.15|
74093312|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.08|||||TWO_SIDED|95.0|-0.19|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.03|-0.19|
74093313|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.12|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.09|-0.12|
74041371|NCT00092677|147634885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|0.8|<=|0.001||95.0|2.4|5.5|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||5.5|2.4|<=0.001
74041372|NCT00092677|147634886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|STANDARD_ERROR_OF_MEAN|1.3|<=|0.001||95.0|-22.6|-17.3|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-17.3|-22.6|<=0.001
74093314|NCT00444457|147738346|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.06|||||TWO_SIDED|95.0|-0.05|0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.17|-0.05|
74093315|NCT00444457|147738347|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.1|||||TWO_SIDED|95.0|-3.3|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Tetanus toxoid: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||3.0|-3.3|
74093316|NCT00444457|147738348|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 1: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.0|-2.1|
74093317|NCT00444457|147738348|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.6|||||TWO_SIDED|95.0|-3.4|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 2: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.0|-3.4|
74093318|NCT00444457|147738348|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.5|||||TWO_SIDED|95.0|-1.5|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 3: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||3.0|-1.5|
74093319|NCT00444457|147738349|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.4|2.2|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Hepatitis B: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.2|-2.4|
74093320|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.0|||||TWO_SIDED|95.0|-0.51|4.75||||||Common serotypes - serotype 4||4.75|-0.51|
74041373|NCT01601704|147634887|NON_INFERIORITY_OR_EQUIVALENCE|At the pre-planned 50% interim analysis, a non-inferiority analysis was conducted based on the estimated hazard ratio (NB32/Placebo) for the time to the first confirmed occurrence of MACE. The upper-bound of the 99.7% confidence interval for the hazard ratio was compared to 1.4, the non-inferiority margin.|Cox Proportional Hazard|0.88|||||TWO_SIDED|99.7|0.57|1.34|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.34|0.57|
74041374|NCT01601704|147634888|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93|||||TWO_SIDED|99.7|0.66|1.33|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.33|0.66|
74041375|NCT01601704|147634889|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.5|||||TWO_SIDED|99.7|0.21|1.19|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.19|0.21|
74041376|NCT01601704|147634890|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.96|||||TWO_SIDED|99.7|0.55|1.67|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.67|0.55|
74093321|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||TWO_SIDED|95.0|-3.09|1.1||||||Common serotypes - serotype 4||1.10|-3.09|
74093322|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.9|||||TWO_SIDED|95.0|-5.58|-0.58||||||Common serotypes - serotype 4||-0.58|-5.58|
74041377|NCT01601704|147634891|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04|||||TWO_SIDED|99.7|0.43|2.55|||||Hazard ratio is based on CPH model with treatment as a factor.|||2.55|0.43|
74093323|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|5.3|||||TWO_SIDED|95.0|1.55|9.19||||||Common serotypes - serotype 6B||9.19|1.55|
74093324|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.4|||||TWO_SIDED|95.0|-2.77|3.66||||||Common serotypes - serotype 6B||3.66|-2.77|
74093325|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.9|||||TWO_SIDED|95.0|-8.82|-1.1||||||Common serotypes - serotype 6B||-1.10|-8.82|
74093326|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-3.13|2.83||||||Common serotypes - serotype 9V||2.83|-3.13|
74093327|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.1|||||TWO_SIDED|95.0|-3.97|1.73||||||Common serotypes - serotype 9V||1.73|-3.97|
74093328|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||TWO_SIDED|95.0|-3.81|1.88||||||Common serotypes - serotype 9V||1.88|-3.81|
74093329|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.27|1.95||||||Common serotypes - serotype 14||1.95|-1.27|
74093330|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.1|||||TWO_SIDED|95.0|-0.6|3.01||||||Common serotypes - serotype 14||3.01|-0.60|
74093331|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-1.04|2.76||||||Common serotypes - serotype 14||2.76|-1.04|
74093332|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.1|||||TWO_SIDED|95.0|-0.38|4.74||||||Common serotypes - serotype 18C||4.74|-0.38|
74093333|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-2.33|1.99||||||Common serotypes - serotype 18C||1.99|-2.33|
74093334|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.2|||||TWO_SIDED|95.0|-4.89|0.23||||||Common serotypes - serotype 18C||0.23|-4.89|
74093335|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.93|2.6||||||Common serotypes - serotype 19F||2.60|-1.93|
74093336|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||TWO_SIDED|95.0|-3.46|0.28||||||Common serotypes - serotype 19F||0.28|-3.46|
74093337|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.8|||||TWO_SIDED|95.0|-3.87|0.02||||||Common serotypes - serotype 19F||0.02|-3.87|
74093338|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.2|||||TWO_SIDED|95.0|-1.03|7.46||||||Common serotypes - serotype 23F||7.46|-1.03|
74093339|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|4.0|||||TWO_SIDED|95.0|-0.27|8.39||||||Common serotypes - serotype 23F||8.39|-0.27|
74093340|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-3.75|5.46||||||Common serotypes - serotype 23F||5.46|-3.75|
74093341|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-1.48|3.18||||||Additional serotypes - serotype 1||3.18|-1.48|
74093342|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.78|1.34||||||Additional serotypes - serotype 1||1.34|-2.78|
74010764|NCT02187471|147572847|SUPERIORITY||Difference in least squares means|0.7358|STANDARD_ERROR_OF_MEAN|0.7358||0.3516|TWO_SIDED|95.0|-0.758|2.129|||ANCOVA|||Mental Component: Placebo vs Pregabalin 150 mg BID||2.129|-0.758|0.3516
74041378|NCT00877006|147634906|SUPERIORITY_OR_OTHER|||||||0.0005||||||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment group, region, preassigned standard treatment, and lymphoma type as factors and baseline value as the covariate.|ANCOVA|||The hypothesis of interest is superiority of BR over standard treatment.||||0.0005
74041379|NCT00877006|147634907|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9677|TWO_SIDED|95.0|0.58|1.68|||Log Rank|Stratified log-rank test by preassigned standard treatment and lymphoma type.|BR/RCHOP-RCVP|||1.68|0.58|0.9677
74041380|NCT01878097|147634968|SUPERIORITY||F-stat|7.12||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
74041381|NCT01878097|147634969|SUPERIORITY||F-stat|7.18||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
74041382|NCT03325556|147634972|SUPERIORITY||Hazard Ratio (HR)|0.353|STANDARD_ERROR_OF_MEAN|0.3676||0.0023|TWO_SIDED|95.0|0.172|0.727||1-sided p-value reported. The protocol-defined O'Brien Flemming stopping boundary for the planned IA was a 1-sided p-value equal to 0.0033|Regression, Cox||Model included covariates for Treatment group, dementia subtype, and region, and robust sandwich-type variance estimator.|||0.727|0.172|0.0023
74041383|NCT03325556|147634973|SUPERIORITY||Hazard Ratio (HR)|0.452|STANDARD_ERROR_OF_MEAN|0.2812||0.0024|TWO_SIDED|95.0|0.261|0.785||1-sided p-value|Regression, Cox||Model included covariates for Treatment group, dementia subtype, and region, and robust sandwich-type variance estimator.|||0.785|0.261|0.0024
74041384|NCT02119026|147634974|SUPERIORITY|||||||0.967|||||||Mantel Haenszel|||||||0.967
74041385|NCT02119026|147634975|SUPERIORITY|||||||0.474|||||||Mantel Haenszel|||||||0.474
74093343|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||TWO_SIDED|95.0|-3.77|0.67||||||Additional serotypes - serotype 1||0.67|-3.77|
74093344|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-3.9|||||TWO_SIDED|95.0|-10.27|2.45||||||Additional serotypes - serotype 3||2.45|-10.27|
74093345|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-10.7|||||TWO_SIDED|95.0|-16.8|-4.57||||||Additional serotypes - serotype 3||-4.57|-16.80|
74093346|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-6.8|||||TWO_SIDED|95.0|-12.76|-0.74||||||Additional serotypes - serotype 3||-0.74|-12.76|
74093347|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.9|||||TWO_SIDED|95.0|0.15|7.69||||||Additional serotypes - serotype 5||7.69|0.15|
74041386|NCT02119026|147634976|SUPERIORITY|||||||0.464|||||||Mantel Haenszel|||||||0.464
74041387|NCT02119026|147634977|SUPERIORITY|||||||0.854|||||||Fisher Exact|||||||0.854
74041388|NCT02119026|147634978|SUPERIORITY|||||||0.728|||||||Mantel Haenszel|||||||0.728
74041389|NCT02119026|147634979|SUPERIORITY|||||||0.668|||||||Mantel Haenszel|||||||0.668
74041390|NCT02119026|147634980|SUPERIORITY|||||||0.618|||||||Mantel Haenszel|||||||0.618
74041391|NCT02119026|147634981|SUPERIORITY|||||||0.792||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)|||||||0.792
74041392|NCT02119026|147634982|SUPERIORITY|||||||0.371||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)|||||||0.371
74041393|NCT00510484|147634983|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74041394|NCT00510484|147634984|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74041395|NCT00510484|147634985|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74041396|NCT00510484|147634986|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74093348|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-3.52|3.09||||||Additional serotypes - serotype 5||3.09|-3.52|
74093349|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.1|||||TWO_SIDED|95.0|-7.92|-0.36||||||Additional serotypes - serotype 5||-0.36|-7.92|
74041397|NCT00510484|147634987|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74093350|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.5|||||TWO_SIDED|95.0|0.12|5.23||||||Additional serotypes - serotype 6A||5.23|0.12|
74093351|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-2.22|1.86||||||Additional serotypes - serotype 6A||1.86|-2.22|
73879495|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.93||0.021|TWO_SIDED|95.0|-8.27|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.68|-8.27|0.0210
74093352|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.7|||||TWO_SIDED|95.0|-5.39|-0.27||||||Additional serotypes - serotype 6A||-0.27|-5.39|
73879496|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.93||0.0002|TWO_SIDED|95.0|-10.98|-3.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.38|-10.98|0.0002
74041398|NCT00510484|147634988|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74041399|NCT00510484|147634989|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.013
74041400|NCT00510484|147634990|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
74041401|NCT00762268|147635004|SUPERIORITY_OR_OTHER|||||||1|||||||Regression, Linear|||||||1.0
74041402|NCT00762268|147635005|OTHER|||||||0.05|||||||Chi-squared|||Change from intake scores.||||0.05
74041403|NCT00762268|147635006|OTHER|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
74041404|NCT00961441|147635007|SUPERIORITY_OR_OTHER||Point estimate for ratio|1.0271|||||TWO_SIDED|90.0|0.8817|1.1964|||ANOVA|Point estimates for the geometric means ratios children/adults for Cmax normalized by dose and body weight and 90% CIs have been calculated.||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).||1.1964|0.8817|
74041405|NCT00961441|147635008|SUPERIORITY_OR_OTHER||Point estimate for ratio|0.9914|||||TWO_SIDED|90.0|0.811|1.2118|||ANOVA|Point estimates for the geometric means ratios children/adults for AUCtau normalized by dose and body weight and 90% CIs have been calculated.||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).||1.2118|0.8110|
74041406|NCT00150345|147635039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.493||||0.258|TWO_SIDED|95.0|0.129|1.755|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event IFI=yes is modeled.|Hypothesis: H0: rv - rp = 0 vs H1: rv - rp does not equal 0, where ri is rate of IFI (i=v for voriconazole group, i=p for deferred voriconazole group). Logit model (including important covariates) used. The adjusted odds ratio and 95 percent (%) confidence interval (CI) for adjusted odds ratio calculated. If 95% CI around odds ratio does not contain a value of 1, then the null hypothesis of equal rates of IFI between immediate voriconazole and deferred voriconazole to be rejected.||1.755|0.129|0.258
74041407|NCT00150345|147635040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.596|TWO_SIDED|95.0|0.398|1.696|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.|||1.696|0.398|0.596
74041408|NCT00150345|147635041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.936||||0.864|TWO_SIDED|95.0|0.441|1.988|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.|||1.988|0.441|0.864
74041409|NCT00150345|147635042|SUPERIORITY_OR_OTHER|||||||0.955|TWO_SIDED||||||Log Rank|||||||0.955
74041410|NCT00150345|147635044|SUPERIORITY_OR_OTHER||Difference in % participants that died|5.85|||||TWO_SIDED|95.0|-5.08|16.78|||||Approximate 2-sided confidence interval (CI).|Difference in proportions expressed as a percent: immediate voriconazole versus (vs) deferred voriconazole treatment||16.78|-5.08|
74041411|NCT00150345|147635045|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||||||0.190
74041412|NCT00150345|147635046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.031|STANDARD_ERROR_OF_MEAN|10.888||0.049|TWO_SIDED|95.0|-44.004|-0.059||SAS PROC REG with SELECTION=STEPWISE option of SLENTRY=0.05 and SLSTAY=0.10 utilized. Stepwise option combined forward stepping (with a 0.05 level to enter) with elimination of variables already in model that do not stay significant at 0.10 level.|Regression, Linear|Variables: association with age, c-reactive protein, and time to continuous defervescence not significant at 0.05 level; not included in final model||Continuous defervescence achieved=Yes||-0.059|-44.004|0.049
74041413|NCT00150345|147635066|SUPERIORITY_OR_OTHER||Difference in percentages|2.51|||||TWO_SIDED|95.0|-14.96|19.97||||||Difference in proportions expressed as a percent: immediate voriconazole vs deferred voriconazole treatment||19.97|-14.96|
74041414|NCT05034614|147635082|SUPERIORITY|||||||0.75|||||||Chi-squared|||||||.75
74041415|NCT03892707|147635086|SUPERIORITY|The between-group comparison on primary endpoint - change from baseline in pain intensity as measured on 0-10 points NRS scale at 10 days after the start of treatment was performed using analysis of covariance (ANCOVA). The difference between pain intensity at 10 days after the start of treatment and baseline (V3-V1) as response variable, treatment group as fixed factor and baseline pain intensity as a covariate was included into the model.|||||<|0.001|||||||ANCOVA|||"Since the superiority of one treatment over the other is investigated and taking into consideration that smaller negative values of the primary variable correspond to the greater reduction of pain, the statistical hypotheses are:~Null hypothesis (H0):~H0: μ2 - μ1 ≥ 0~Alternative hypothesis (HA):~HA: μ2 - μ1 \< 0, where μ1 и μ2 are the mean changes from baseline in pain intensity for (1) modern NSAIDs therapy and for (2) modern NSAIDs + Milgamma\\ Milgamma compositum therapy, correspondingly."||||<0.001
74041416|NCT03892707|147635087|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes from baseline in pain intensity measured on 0-10 points NRS scale at 5, 24 and 38 days after were compared between groups using ANCOVA models similar to those used for the analysis of the primary variable.||||<0.001
74093353|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-0.47|2.3||||||Additional serotypes - serotype 7F||2.30|-0.47|
74093354|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-1.12|1.18||||||Additional serotypes - serotype 7F||1.18|-1.12|
74093355|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.3|0.52||||||Additional serotypes - serotype 7F||0.52|-2.30|
74093356|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.0|||||TWO_SIDED|95.0|-2.91|0.8||||||Additional serotypes - serotype 19A||0.80|-2.91|
74093357|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.69|1.19||||||Additional serotypes - serotype 19A||1.19|-2.69|
74093358|NCT00444457|147738350|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.4|2.04||||||Additional serotypes - serotype 19A||2.04|-1.40|
74041417|NCT03892707|147635088|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
74041418|NCT03892707|147635089|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.|||||<|0.001|||||||Regression, Logistic|||For Visit 2 (5 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 2)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||<0.001
74093359|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.1|||||TWO_SIDED|95.0|-1.61|1.81|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||1.81|-1.61|
74093360|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||TWO_SIDED|95.0|-2.39|0.23|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||0.23|-2.39|
74093361|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-2.54|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||0.20|-2.54|
74093362|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.02|1.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.11|-1.02|
74093363|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.04|-1.03|
74093364|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.13|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.06|-1.13|
74093365|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.25|1.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||1.37|-1.25|
74041419|NCT03892707|147635089|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.|||||<|0.001|||||||Regression, Logistic|||For Visit 3 (10 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 3)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||<0.001
74041420|NCT03892707|147635089|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.||||||0.061|||||||Regression, Logistic|||For Visit 4 (24 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 4)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||0.061
74041421|NCT03892707|147635090|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Change from baseline in pain-related disability as measured by Roland Morris disability questionnaire at 10 days after the start of treatment was compared between groups using analysis of covariance (ANCOVA) model with treatment group as fixed factor and baseline value disability score as a covariate.||||<0.001
74041422|NCT03892707|147635091|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Episode of pain flare-up was defined as presence of at least 1 day with pain following a period without pain lasting at least 4 weeks . The denominator for the proportion was the number of FAS patients who had at least one pain-free period with approximately 4 weeks duration registered during the study.||||<0.001
74041423|NCT03892707|147635092|SUPERIORITY||Difference in proportion|28.6|||||TWO_SIDED|95.0|-3.6|60.7||||||Difference in proportion of patients with at least one pain flare-up resulting in consultancy with physician||60.7|-3.6|
74041424|NCT03892707|147635092|SUPERIORITY||Difference in proportion|-17.1|||||TWO_SIDED|95.0|-51.6|17.4||||||Difference in proportion of patients with at least one pain flare-up resulting in disruption of daily activity||17.4|-51.6|
74041425|NCT03892707|147635092|SUPERIORITY||Difference in proportion|25.7|||||TWO_SIDED|95.0|-4.1|55.5||||||Difference in proportion of patients with at least one pain flare-up resulting in NSAIDs intake||55.5|-4.1|
74041426|NCT03892707|147635093|SUPERIORITY|||||||0.986|||||||Wilcoxon (Mann-Whitney)|||NSAIDs intake during the study was analyzed. In order to calculate the total number of treatment days with NSAIDs, first, intersecting or adjacent records were collapsed, irrespective of the specific drug used; the duration of each of the resulting intake periods was determined as (End date - Start date + 1) and, finally, all individual duration values were summed up. In case medication intake was ongoing at the end of study, end date was imputed by the date of study completion.||||0.986
74041427|NCT03892707|147635096|SUPERIORITY|||||||0.921|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 5 days since the start of study treatment.||||0.921
74041428|NCT03892707|147635096|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 10 days since the start of study treatment||||0.051
74041429|NCT03892707|147635096|SUPERIORITY|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 38 days since the start of study treatment||||0.651
74041430|NCT03892707|147635096|SUPERIORITY|||||||0.106|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 3 months since the start of study treatment||||0.106
74041431|NCT01807949|147635100|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|2.62||||0.0004|TWO_SIDED|95.0|1.18|4.06|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than \[\<\] 18 versus greater than equal to \[\>=\]18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.06|1.18|0.0004
74041432|NCT01807949|147635100|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|||<|0.0001|TWO_SIDED|95.0|1.56|4.44|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.44|1.56|<0.0001
74041433|NCT01807949|147635101|SUPERIORITY_OR_OTHER||LS Mean Difference|4.42||||0.0007|TWO_SIDED|95.0|1.86|6.98|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||6.98|1.86|0.0007
74041434|NCT01807949|147635101|SUPERIORITY_OR_OTHER||LS Mean Difference|5.25|||<|0.0001|TWO_SIDED|95.0|2.69|7.81|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||7.81|2.69|<0.0001
74041435|NCT01807949|147635102|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.0001|TWO_SIDED|95.0|0.23|0.59|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI.||0.59|0.23|<0.0001
74041436|NCT01807949|147635102|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.0001|TWO_SIDED|95.0|0.17|0.54|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||0.54|0.17|0.0001
74041437|NCT01807949|147635103|SUPERIORITY_OR_OTHER||LS Mean Difference|2.21||||0.1651|TWO_SIDED|95.0|-0.91|5.33|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline CFQ-R respiratory domain score.||5.33|-0.91|0.1651
74041438|NCT01807949|147635103|SUPERIORITY_OR_OTHER||LS Mean Difference|2.85||||0.0736|TWO_SIDED|95.0|-0.27|5.98|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||5.98|-0.27|0.0736
74041439|NCT01807949|147635104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9568|||<|0.0001|TWO_SIDED|95.0|1.8829|4.6431||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.6431|1.8829|<0.0001
74041440|NCT01807949|147635104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3834||||0.0001|TWO_SIDED|95.0|1.5234|3.7286||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||3.7286|1.5234|0.0001
74041441|NCT01807949|147635105|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.6912||||0.0116|TWO_SIDED|95.0|0.5187|0.9209||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70) as covariates with the logarithm of time on study as the offset.||0.9209|0.5187|0.0116
74041442|NCT01807949|147635105|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.5659||||0.0002|TWO_SIDED|95.0|0.4191|0.7641||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.||0.7641|0.4191|0.0002
74041443|NCT01807949|147635106|SUPERIORITY_OR_OTHER||LS Mean Difference|1.13|||<|0.0001|TWO_SIDED|95.0|0.62|1.64|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline weight.||1.64|0.62|<0.0001
74041444|NCT01807949|147635106|SUPERIORITY_OR_OTHER||LS Mean Difference|0.95||||0.0003|TWO_SIDED|95.0|0.43|1.46|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||1.46|0.43|0.0003
74041445|NCT01807949|147635107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2313||||0.0005|TWO_SIDED|95.0|0.1037|0.3589|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI z-score.||0.3589|0.1037|0.0005
74041446|NCT01807949|147635107|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2217||||0.0006|TWO_SIDED|95.0|0.0961|0.3473|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.3473|0.0961|0.0006
74041447|NCT01807949|147635108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.716||||0.0384|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||||0.0384
74041448|NCT01807949|147635108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.533||||0.0003|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.||||0.0003
74041449|NCT01807949|147635109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6373||||0.0393|TWO_SIDED|95.0|0.416|0.9764|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||0.9764|0.4160|0.0393
74041450|NCT01807949|147635109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4429||||0.0002|TWO_SIDED|95.0|0.2863|0.6851|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||0.6851|0.2863|0.0002
74041451|NCT01807949|147635110|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0028||||0.7679|TWO_SIDED|95.0|-0.0211|0.0156|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L index score.||0.0156|-0.0211|0.7679
74041452|NCT01807949|147635110|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0009||||0.9214|TWO_SIDED|95.0|-0.0192|0.0174|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.0174|-0.0192|0.9214
74041453|NCT01807949|147635111|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4||||0.1034|TWO_SIDED|95.0|-0.5|5.3|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L VAS score.||5.3|-0.5|0.1034
74093366|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.76|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||2.18|-0.76|
74041454|NCT01807949|147635111|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0262|TWO_SIDED|95.0|0.4|6.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||6.2|0.4|0.0262
74041455|NCT01807949|147635112|SUPERIORITY_OR_OTHER||LS Mean Difference|8.64||||0.0005|TWO_SIDED|95.0|3.77|13.51|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM effectiveness score.||13.51|3.77|0.0005
74041456|NCT01807949|147635112|SUPERIORITY_OR_OTHER||LS Mean Difference|11.61|||<|0.0001|TWO_SIDED|95.0|6.75|16.48|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.||16.48|6.75|<0.0001
74041457|NCT01807949|147635112|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.18||||0.0403|TWO_SIDED|95.0|-6.21|-0.14|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM side effects score.||-0.14|-6.21|0.0403
74041458|NCT01807949|147635112|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.29||||0.0054|TWO_SIDED|95.0|-7.31|-1.28|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.||-1.28|-7.31|0.0054
74041459|NCT01807949|147635112|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||1|TWO_SIDED|95.0|-4.07|4.07|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM convenience score.||4.07|-4.07|1.0000
74041460|NCT01807949|147635112|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.8777|TWO_SIDED|95.0|-3.74|4.37|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.||4.37|-3.74|0.8777
74093367|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-0.87|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||2.18|-0.87|
73879497|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.3|STANDARD_ERROR_OF_MEAN|1.94||0.0002|TWO_SIDED|95.0|-11.12|-3.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.49|-11.12|0.0002
74041461|NCT01807949|147635112|SUPERIORITY_OR_OTHER||LS Mean Difference|4.64||||0.0668|TWO_SIDED|95.0|-0.32|9.61|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM global satisfaction score.||9.61|-0.32|0.0668
74041462|NCT01807949|147635112|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16||||0.0045|TWO_SIDED|95.0|2.23|12.08|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.||12.08|2.23|0.0045
74041463|NCT01457924|147635115|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||Note: There is a discrepancy in the number of par. in ITT populations at Wk 24 and Wk 48: 228 and 229 respectively. This resulted from a data issue: one par was incorrectly excluded from ITT pop. at Wk 24, but correctly included in Wk 48. This error affects all source tables, analyses relating to ITT and per protocol populations, primary endpoint and secondary MRI endpoints reported at Wk 24. This discrepancy affects all statistical analyses, but not summary statistics.||0.548|0.221|<0.001
74041464|NCT01457924|147635115|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
74041465|NCT01457924|147635115|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
74041466|NCT01457924|147635115|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
74041467|NCT01457924|147635116|SUPERIORITY_OR_OTHER||Ratio|0.38||||0.003|TWO_SIDED|95.0|0.2|0.72|||Generalized Linear Model|||||0.72|0.20|0.003
74041468|NCT01457924|147635116|SUPERIORITY_OR_OTHER||Ratio|0.38||||0.003|TWO_SIDED|95.0|0.2|0.72|||Generalized Linear Model|||||0.72|0.20|0.003
74041469|NCT01457924|147635116|SUPERIORITY_OR_OTHER||Ratio|0.35||||0.001|TWO_SIDED|95.0|0.19|0.65|||Generalized Linear Model|||||0.65|0.19|0.001
74041470|NCT01457924|147635116|SUPERIORITY_OR_OTHER||Ratio|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.39|||Generalized Linear Model|||||0.39|0.13|<0.001
74041471|NCT01457924|147635119|SUPERIORITY_OR_OTHER||Ratio|0.31|||<|0.001|TWO_SIDED|95.0|0.16|0.6|||Generalized Linear Model|||||0.60|0.16|<0.001
74041472|NCT01457924|147635119|SUPERIORITY_OR_OTHER||Ratio|0.56||||0.075|TWO_SIDED|95.0|0.29|1.06|||Generalized Linear Model|||||1.06|0.29|0.075
74041473|NCT01457924|147635119|SUPERIORITY_OR_OTHER||Ratio|0.51||||0.035|TWO_SIDED|95.0|0.27|0.95|||Generalized Linear Model|||||0.95|0.27|0.035
74041474|NCT01457924|147635119|SUPERIORITY_OR_OTHER||Ratio|0.32|||<|0.001|TWO_SIDED|95.0|0.19|0.55|||Generalized Linear Model|||||0.55|0.19|<0.001
74041475|NCT01457924|147635120|SUPERIORITY_OR_OTHER||Ratio|0.22||||0.026|TWO_SIDED|95.0|0.06|0.84|||Generalized Linear Model|||||0.84|0.06|0.026
74041476|NCT01457924|147635120|SUPERIORITY_OR_OTHER||Ratio|0.49||||0.296|TWO_SIDED|95.0|0.13|1.86|||Generalized Linear Model|||||1.86|0.13|0.296
74041477|NCT01457924|147635120|SUPERIORITY_OR_OTHER||Ratio|0.5||||0.285|TWO_SIDED|95.0|0.14|1.78|||Generalized Linear Model|||||1.78|0.14|0.285
74041478|NCT01457924|147635120|SUPERIORITY_OR_OTHER||Ratio|0.25||||0.009|TWO_SIDED|95.0|0.09|0.71|||Non-Linear Emax Model|||||0.71|0.09|0.009
74041479|NCT01457924|147635121|SUPERIORITY_OR_OTHER||Ratio|0.18||||0.004|TWO_SIDED|95.0|0.05|0.58|||Generalized Linear Model|||||0.58|0.05|0.004
74041480|NCT01457924|147635121|SUPERIORITY_OR_OTHER||Ratio|0.5||||0.248|TWO_SIDED|95.0|0.15|1.63|||Generalized Linear Model|||||1.63|0.15|0.248
74041481|NCT01457924|147635121|SUPERIORITY_OR_OTHER||Ratio|0.46||||0.181|TWO_SIDED|95.0|0.15|1.43|||Generalized Linear Model|||||1.43|0.15|0.181
74041482|NCT01457924|147635121|SUPERIORITY_OR_OTHER||Ratio|0.24||||0.003|TWO_SIDED|95.0|0.1|0.62|||Generalized Linear Model|||||0.62|0.10|0.003
74041483|NCT01457924|147635122|SUPERIORITY_OR_OTHER||Ratio|0.29|||<|0.001|TWO_SIDED|95.0|0.15|0.58|||Generalized Linear Model|||||0.58|0.15|<0.001
74041484|NCT01457924|147635122|SUPERIORITY_OR_OTHER||Ratio|0.34||||0.002|TWO_SIDED|95.0|0.17|0.68|||Generalized Linear Model|||||0.68|0.17|0.002
74041485|NCT01457924|147635122|SUPERIORITY_OR_OTHER||Ratio|0.4||||0.006|TWO_SIDED|95.0|0.21|0.77|||Generalized Linear Model|||||0.77|0.21|0.006
74041486|NCT01457924|147635122|SUPERIORITY_OR_OTHER||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.11|0.35|||Generalized Linear Model|||||0.35|0.11|<0.001
74041487|NCT01181141|147635126|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-3.5|||||TWO_SIDED|95.0|-18.8|6.0|||Wilcoxon (Mann-Whitney)|||||6.0|-18.8|
74041488|NCT00118911|147635131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.631|STANDARD_DEVIATION|7.337|<|0.03|TWO_SIDED|95.0|-8.3|-0.963|||ANCOVA|We used multiple imputation.||Hypothesis was that CBT would be superior to RES||-0.963|-8.30|<.03
74041489|NCT00118911|147635132|SUPERIORITY_OR_OTHER||Slope|-0.12|STANDARD_DEVIATION|0.59|>|0.05|TWO_SIDED|95.0|-0.41|0.18|||Mixed Models Analysis||Those who were assigned to CBT and made a partial or full response maintained their gains over follow-up|We examined whether those in the CBT condition maintained their gains over time. Analysis was restricted to those assigned to CBT who were responders or partial responders.||.18|-.41|>.05
74041490|NCT00835003|147635153|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations estimated a sample size of 1272 women with an estimated proportion of 8% in the 39 weeks Group and 14% in the 38 weeks group|Risk Ratio (RR)|0.86||||0.31|TWO_SIDED|95.0|0.65|1.15|||Chi-squared|||||1.15|0.65|0.31
74041491|NCT04446299|147635192|NON_INFERIORITY|The predetermined non-inferiority margin was 10%.|Risk Difference (RD)|3.42|||<|0.001|TWO_SIDED|95.0|-1.68|8.52|||Mantel Haenszel|||||8.52|-1.68|<0.001
74041492|NCT03819478|147635193|SUPERIORITY|||||||0.488|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.4880
74041493|NCT03819478|147635193|SUPERIORITY|||||||0.1683|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1683
74041494|NCT03819478|147635194|SUPERIORITY|||||||0.7636|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.7636
74041495|NCT03819478|147635195|SUPERIORITY|||||||0.1584|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1584
74041496|NCT03819478|147635195|SUPERIORITY|||||||0.1623|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1623
73887977|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|154.3||||0.003|TWO_SIDED|95.0|53.3|255.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||255.3|53.3|0.0030
74010765|NCT02187471|147572847|SUPERIORITY||Difference in least squares means|-0.458|STANDARD_ERROR_OF_MEAN|0.7372||0.5344|TWO_SIDED|95.0|-1.905|0.988|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.988|-1.905|0.5344
74010766|NCT02187471|147572847|SUPERIORITY||Difference in least squares means|0.607|STANDARD_ERROR_OF_MEAN|0.7379||0.4107|TWO_SIDED|95.0|-0.84|2.055|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||2.055|-0.840|0.4107
74010767|NCT02187471|147572848|SUPERIORITY||Difference in least squares means|0.0203|STANDARD_ERROR_OF_MEAN|0.01369||0.1394|TWO_SIDED|95.0|-0.0066|0.0471|||ANCOVA|||||0.0471|-0.0066|0.1394
74041497|NCT03819478|147635196|SUPERIORITY|||||||0.035|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.0350
74041498|NCT03819478|147635197|SUPERIORITY|||||||0.2422|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.2422
74041499|NCT03819478|147635197|SUPERIORITY|||||||0.5082|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5082
74041500|NCT03819478|147635198|SUPERIORITY|||||||0.5119|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5119
74041501|NCT03819478|147635198|SUPERIORITY|||||||0.4902|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.4902
74041502|NCT03819478|147635199|SUPERIORITY|||||||0.85|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.8500
74041503|NCT03819478|147635200|SUPERIORITY|||||||0.3685|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.3685
74041504|NCT03819478|147635200|SUPERIORITY|||||||0.0894|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.0894
74041505|NCT03819478|147635201|SUPERIORITY|||||||0.5334|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5334
74041506|NCT03819478|147635202|SUPERIORITY|||||||0.1573|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1573
74041507|NCT01135017|147635216|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|-59.13|STANDARD_ERROR_OF_MEAN|0.275||0.0015|TWO_SIDED|95.0|-76.322|-29.457||No adjustment for multiplicity was made. The priori threshold for statistical significance was ≤0.05.|ANCOVA|ANCOVA model on log-transformed AF burden data with treatment arm as a fixed effect term and baseline log-transformed AF burden as a covariate|"Percent change in AF burden with dronedarone relative to placebo~LS Mean difference from the ANCOVA model on log-transformed AF burden data was exponentiated to convert back to percent change."|"The planned sample size of 286 participants was estimated to have 70% power to detect a reduction in mean AF burden of 30% relative to the placebo group.~Due to the smaller-than-planned sample size, the power to detect this difference was estimated to be only 44%, based on the original assumption. However, the power to detect larger treatment effects (\>40% reduction) remained high and the posthoc power to detect a 60% reduction in AF burden was 99%."||-29.457|-76.322|0.0015
74041508|NCT01148693|147635222|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||Null hypothesis: Adding gentamicin to contrast medium during ERCP has no relation with postERCP cholangitis Power calculation: 80%||||<0.05
74041509|NCT04024072|147635283|EQUIVALENCE|8AM Day 14|Mean Difference (Net)|-0.46|||||TWO_SIDED|95.0|-0.93|0.01||||||||0.01|-0.93|
74041510|NCT04024072|147635283|EQUIVALENCE|10AM Day 14|Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.7|0.24||||||||0.24|-0.70|
74041511|NCT04024072|147635283|EQUIVALENCE|8AM Day 42|Mean Difference (Net)|-0.24|||||TWO_SIDED|95.0|-0.74|0.27||||||||0.27|-0.74|
74041512|NCT04024072|147635283|EQUIVALENCE|10AM Day 42|Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.51|0.51||||||||0.51|-0.51|
74041513|NCT04491240|147635311|SUPERIORITY||Mean Difference (Net)|73.29|STANDARD_DEVIATION|82.91404||0.020875|TWO_SIDED|95.0|13.97687|132.6031|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||132.6031|13.97687|0.020875
74041514|NCT04491240|147635311|SUPERIORITY||Mean Difference (Net)|69.56|STANDARD_DEVIATION|45.67648||0.000953|TWO_SIDED|95.0|36.88502|102.235|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||102.2350|36.88502|0.000953
74093368|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.74|1.62|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.62|-0.74|
74093369|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.04|-1.03|
74010768|NCT02187471|147572848|SUPERIORITY||Difference in least squares means|0.0211|STANDARD_ERROR_OF_MEAN|0.01369||0.1237|TWO_SIDED|95.0|-0.0058|0.048|||ANCOVA|||||0.0480|-0.0058|0.1237
74010769|NCT02187471|147572848|SUPERIORITY||Difference in least squares means|0.0386|STANDARD_ERROR_OF_MEAN|0.01371||0.0049|TWO_SIDED|95.0|0.0117|0.0655|||ANCOVA|||||0.0655|0.0117|0.0049
74010770|NCT02187471|147572848|SUPERIORITY||Difference in least squares means|-0.0184|STANDARD_ERROR_OF_MEAN|0.01378||0.1824|TWO_SIDED|95.0|-0.0454|0.0086|||ANCOVA|||||0.0086|-0.0454|0.1824
74010771|NCT02187471|147572848|SUPERIORITY||Difference in least squares means|-0.0175|STANDARD_ERROR_OF_MEAN|0.01378||0.2036|TWO_SIDED|95.0|-0.0446|0.0095|||ANCOVA|||||0.0095|-0.0446|0.2036
74010772|NCT02187471|147572849|SUPERIORITY||Difference in least squares means|-0.56|STANDARD_ERROR_OF_MEAN|0.162||0.0006|TWO_SIDED|95.0|-0.87|-0.24|||Mixed Models Analysis|||||-0.24|-0.87|0.0006
74010773|NCT02187471|147572849|SUPERIORITY||Difference in least squares means|-0.88|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.2|-0.57|||Mixed Models Analysis|||||-0.57|-1.20|<0.0001
74010774|NCT02187471|147572849|SUPERIORITY||Difference in least squares means|-0.95|STANDARD_ERROR_OF_MEAN|0.161|<|0.0001|TWO_SIDED|95.0|-1.27|-0.63|||Mixed Models Analysis|||||-0.63|-1.27|<0.0001
74010775|NCT02187471|147572849|SUPERIORITY||Difference in least squares means|0.39|STANDARD_ERROR_OF_MEAN|0.162||0.0158|TWO_SIDED|95.0|0.07|0.71|||Mixed Models Analysis|||||0.71|0.07|0.0158
74010776|NCT02187471|147572849|SUPERIORITY||Difference in least squares means|0.07|STANDARD_ERROR_OF_MEAN|0.161||0.6819|TWO_SIDED|95.0|-0.25|0.38|||Mixed Models Analysis|||||0.38|-0.25|0.6819
74010777|NCT02187471|147572851|SUPERIORITY||Difference of least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.2|<0.0001
74010778|NCT02187471|147572851|SUPERIORITY||Difference of least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2005|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.1|-0.6|0.2005
74010779|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||-0.3|-1.0|0.0010
74010780|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.0|0.2|0.0030
74010781|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3351|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.3351
74010782|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|<0.0001
74041515|NCT04491240|147635311|SUPERIORITY||Mean Difference (Net)|53.21|STANDARD_DEVIATION|39.85531||0.002233|TWO_SIDED|95.0|24.69923|81.72077|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||81.72077|24.69923|0.002233
74041516|NCT04491240|147635312|SUPERIORITY||Mean Difference (Net)|331.52|STANDARD_DEVIATION|315.823||0.008948|TWO_SIDED|95.0|105.5938|557.4462|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||557.4462|105.5938|0.008948
74093370|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.61|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||0.76|-1.61|
74010783|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0782|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.0|-0.7|0.0782
74010784|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0068|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||-0.1|-0.9|0.0068
74010785|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0169|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|0.1|0.0169
74010786|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1481|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.1|0.1481
74010787|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|<0.0001
74010788|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0088|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||-0.1|-0.8|0.0088
74010789|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0005|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||-0.3|-0.9|0.0005
74010790|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0627|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.0|0.0627
74010791|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3064|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.3064
74010792|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||-0.4|-1.2|<0.0001
74010793|NCT02187471|147572851|SUPERIORITY||Difference in least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0868|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.0|-0.7|0.0868
74010794|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0004|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||-0.3|-1.1|0.0004
74010795|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0271|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|0.1|0.0271
74010796|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6838|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.3|0.6838
74010797|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.791|STANDARD_ERROR_OF_MEAN|0.172|<|0.0001|TWO_SIDED|95.0|-1.129|-0.454|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||-0.454|-1.129|<0.0001
73879498|NCT03192176|147297613|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|-12.99|-5.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-5.25|-12.99|<0.0001
73879499|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.96||0.0047|TWO_SIDED|95.0|-9.45|-1.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.73|-9.45|0.0047
73879500|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.94||0.0009|TWO_SIDED|95.0|-10.29|-2.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.67|-10.29|0.0009
74010798|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.33|STANDARD_ERROR_OF_MEAN|0.1718||0.0552|TWO_SIDED|95.0|-0.667|0.007|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.007|-0.667|0.0552
74010799|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-0.612|STANDARD_ERROR_OF_MEAN|0.1718||0.0004|TWO_SIDED|95.0|-0.95|-0.275|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||-0.275|-0.950|0.0004
74010800|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|0.462|STANDARD_ERROR_OF_MEAN|0.1729||0.0077|TWO_SIDED|95.0|0.122|0.801|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.801|0.122|0.0077
74010801|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|0.179|STANDARD_ERROR_OF_MEAN|0.173||0.3014|TWO_SIDED|95.0|-0.161|0.518|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.518|-0.161|0.3014
74010802|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|9.6|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001|TWO_SIDED|95.0|4.9|14.3|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs Pregabalin 150 mg BID||14.3|4.9|<0.0001
74010803|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|8.5|STANDARD_ERROR_OF_MEAN|2.39||0.0004|TWO_SIDED|95.0|3.8|13.2|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg QD||13.2|3.8|0.0004
74010804|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|10.4|STANDARD_ERROR_OF_MEAN|2.39|<|0.0001|TWO_SIDED|95.0|5.7|15.1|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg BID||15.1|5.7|<0.0001
74010805|NCT02187471|147572851|SUPERIORITY||Difference in least squares means|-1.1|STANDARD_ERROR_OF_MEAN|2.41||0.6449|TWO_SIDED|95.0|-5.8|3.6|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||3.6|-5.8|0.6449
74010806|NCT02187471|147572851|SUPERIORITY||Difference in least square means|0.8|STANDARD_ERROR_OF_MEAN|2.41||0.734|TWO_SIDED|95.0|-3.9|5.5|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||5.5|-3.9|0.7340
74010807|NCT02187471|147572852|SUPERIORITY||Difference in least squares means|-0.016|STANDARD_ERROR_OF_MEAN|0.0225||0.4816|TWO_SIDED|95.0|-0.06|0.028|||ANCOVA|||||0.028|-0.060|0.4816
74010808|NCT02187471|147572852|SUPERIORITY||Difference in least square means|-0.064|STANDARD_ERROR_OF_MEAN|0.0225||0.0044|TWO_SIDED|95.0|-0.109|-0.02|||ANCOVA|||||-0.020|-.109|0.0044
74041517|NCT04491240|147635312|SUPERIORITY||Mean Difference (Net)|366.63|STANDARD_DEVIATION|414.9726||0.020921|TWO_SIDED|95.0|69.77651|663.4835|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||663.4835|69.77651|0.020921
74041518|NCT04491240|147635312|SUPERIORITY||Mean Difference (Net)|239.2|STANDARD_DEVIATION|204.0934||0.004873|TWO_SIDED|95.0|93.20037|385.1996|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||385.1996|93.20037|0.004873
74010809|NCT02187471|147572852|SUPERIORITY||Difference in least squares means|-0.074|STANDARD_ERROR_OF_MEAN|0.0226||0.001|TWO_SIDED|95.0|-0.119|-0.03|||ANCOVA|||||-0.030|-0.119|0.0010
74010810|NCT02187471|147572852|SUPERIORITY||Difference in least squares means|0.059|STANDARD_ERROR_OF_MEAN|0.0226||0.0094|TWO_SIDED|95.0|0.014|0.103|||ANCOVA|||||0.103|0.014|0.0094
74010811|NCT02187471|147572852|SUPERIORITY||Difference in least squares means|0.01|STANDARD_ERROR_OF_MEAN|0.0226||0.6527|TWO_SIDED|95.0|-0.034|0.055|||ANCOVA|||||0.055|-0.034|0.6527
74010812|NCT01785160|147572854|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability (No formal testing was performed)|Adjusted Geometric Mean ratio|272.06|STANDARD_DEVIATION|67.9||0.9999||95.0|199.69|370.66||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir||370.66|199.69|0.9999
74010813|NCT01785160|147572855|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability(No formal testing was performed)|Adjusted Geometric Mean ratio|245.72|STANDARD_DEVIATION|87.1||0.9973||95.0|168.46|358.404||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir||358.404|168.460|0.9973
74093371|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.4|||||TWO_SIDED|95.0|-1.52|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||2.39|-1.52|
74093372|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||1.04|-2.30|
74093373|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-2.87|0.74|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.74|-2.87|
74093374|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.55|1.5|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||1.50|-2.55|
74093375|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.1|||||TWO_SIDED|95.0|-3.06|0.57|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||0.57|-3.06|
74093376|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||TWO_SIDED|95.0|-2.44|1.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||1.00|-2.44|
74093377|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.21|2.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||2.05|-1.21|
74093378|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.1|||||TWO_SIDED|95.0|-0.52|3.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||3.16|-0.52|
74093379|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-1.05|2.87|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||2.87|-1.05|
74093380|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||TWO_SIDED|95.0|-0.17|2.53|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||2.53|-0.17|
74093381|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-0.2|2.44|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||2.44|-0.20|
74093382|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.79|1.66|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||1.66|-1.79|
74010814|NCT02081534|147572862|SUPERIORITY|||||||0.012|||||||ANCOVA|||||||0.012
74093383|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|2.8|||||TWO_SIDED|95.0|-2.85|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||8.55|-2.85|
74093384|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.9|||||TWO_SIDED|95.0|-9.99|0.21|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||0.21|-9.99|
74093385|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-7.7|||||TWO_SIDED|95.0|-13.14|-2.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||-2.37|-13.14|
74093386|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.0|1.84|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.84|-1.00|
74093387|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.27|1.3|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.30|-1.27|
74093388|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.84|1.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.02|-1.84|
74093389|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.04|1.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.08|-1.04|
74093390|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.76|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.56|-0.76|
74093391|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.83|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.56|-0.83|
74093392|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.47|2.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||2.09|-0.47|
74093393|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.48|2.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||2.00|-0.48|
74093394|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.59|1.49|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||1.49|-1.59|
74093395|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.04|1.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.09|-1.04|
74093396|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.05|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.04|-1.05|
74093397|NCT00444457|147738351|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.09|1.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.07|-1.09|
74093398|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.4|||||TWO_SIDED|95.0|-6.52|3.63|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||3.63|-6.52|
74093399|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.7|||||TWO_SIDED|95.0|-11.3|-2.15|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||-2.15|-11.30|
74093400|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.2|||||TWO_SIDED|95.0|-9.85|-0.79|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||-0.79|-9.85|
74093401|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.19|2.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||2.07|-1.19|
74093402|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.69|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.06|-1.69|
73887978|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|146.8||||0.0046|TWO_SIDED|95.0|45.9|247.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||247.8|45.9|0.0046
74093403|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||TWO_SIDED|95.0|-2.27|0.75|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||0.75|-2.27|
74093404|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.8|||||TWO_SIDED|95.0|-9.46|1.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||1.82|-9.46|
74093405|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.7|||||TWO_SIDED|95.0|-10.24|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||0.76|-10.24|
74093406|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-6.3|4.41|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||4.41|-6.30|
74093407|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.2|||||TWO_SIDED|95.0|-2.14|1.73|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.73|-2.14|
74093408|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.69|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||2.39|-1.69|
74093409|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-1.46|2.59|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||2.59|-1.46|
74010815|NCT02318667|147572865|OTHER|||||||0.0074|||||||t-test, 2 sided|||||||0.0074
74010816|NCT02318667|147572866|OTHER|||||||0.1506|||||||t-test, 2 sided|||||||0.1506
74010817|NCT04223843|147572923|OTHER||Difference of adjusted means|0.336|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.246|0.425|||ANCOVA|Model included fixed categorical effects of treatment and the fixed continous effect of baseline FEV1 AUC0-3.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean FEV1 AUC0-3 change from baseline between Tio+Olo and matching placebo.||0.425|0.246|<0.0001
74010818|NCT04223843|147572923|OTHER||Difference of adjusted means|0.321|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.233|0.409|||ANCOVA|Model included the fixed categorical effect of treatment and the fixed continuous effect of baseline FEV1 AUC0-3h.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean FEV1 AUC0-3h change from baseline between Tio+Olo and matching placebo.||0.409|0.233|<0.0001
74010819|NCT04223843|147572924|OTHER||Difference of adjusted means|0.201|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.117|0.286|||Mixed Models Analysis|Mixed model with repeated measures including fixed categorial effect of treatment at each visit and fixed continuous effect of baseline at each visit.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean trough FEV1 change from baseline between Tio+Olo and matching placebo.||0.286|0.117|<0.0001
74010820|NCT04223843|147572924|OTHER||Difference of adjusted means|0.217|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.135|0.299|||Mixed Models Analysis|Mixed model with repeated measures including fixed categorial effect of treatment at each visit and fixed continuous effect of baseline at each visit.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean trough FEV1 change from baseline between Tio+Olo and matching placebo.||0.299|0.135|<0.0001
74010821|NCT02636582|147572933|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
74010822|NCT02636582|147572934|SUPERIORITY|||||||0.964|||||||Wilcoxon (Mann-Whitney)|||||||0.964
74041519|NCT03549117|147635313|SUPERIORITY||Least square (LS) mean difference|0.15||||0.8142|TWO_SIDED|95.0|-1.14|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||1.45|-1.14|0.8142
74041520|NCT03549117|147635313|SUPERIORITY||LS mean difference|-0.7||||0.369|TWO_SIDED|95.0|-2.23|0.84||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.||0.84|-2.23|0.3690
74041521|NCT03549117|147635313|SUPERIORITY||LS mean difference|-0.18||||0.7995|TWO_SIDED|95.0|-1.61|1.25||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline; between treatment 95% CI.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.||1.25|-1.61|0.7995
74041522|NCT03549117|147635313|SUPERIORITY||LS mean difference|0.15||||0.7285|TWO_SIDED|95.0|-0.69|0.98||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.||0.98|-0.69|0.7285
74010823|NCT02636582|147572935|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
74010824|NCT02636582|147572936|OTHER|||||||0.172||||||HER2 expression - biopsy|Fisher Exact|||||||0.172
74041523|NCT03549117|147635314|SUPERIORITY||LS mean difference|-0.18||||0.7961|TWO_SIDED|95.0|-1.52|1.17||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||1.17|-1.52|0.7961
74041524|NCT03549117|147635314|SUPERIORITY||LS mean difference|-0.86||||0.271|TWO_SIDED|95.0|-2.41|0.68||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.||0.68|-2.41|0.2710
74010825|NCT02636582|147572936|OTHER|||||||0.38||||||HER2 expression - resection|Fisher Exact|||||||0.38
74010826|NCT03596866|147572956|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.8672|TWO_SIDED|95.0|0.658|1.424||P-value from a 2-sided stratified log-rank test using the stratification factors: presence of intracranial central nervous system (CNS) metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.|2-sided Stratified Log-rank Test||The hazard ratio was obtained using the stratified Cox regression model with the same stratification factors.|||1.424|0.658|=0.8672
74010827|NCT03596866|147572957|SUPERIORITY||Hazard Ratio (HR)|1.592|||=|0.0713|TWO_SIDED|95.0|0.956|2.652||P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Log Rank||The HR was obtained using the stratified Cox regression model with the same stratification factors.|||2.652|0.956|=0.0713
74010828|NCT03596866|147572958|SUPERIORITY||Hazard Ratio (HR)|1.232|||=|0.2501|TWO_SIDED|95.0|0.862|1.761||P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Log Rank||The HR was obtained using the stratified Cox regression model with the same stratification factors.|||1.761|0.862|=0.2501
74010829|NCT03596866|147572959|SUPERIORITY||Odds Ratio (OR)|0.7|||=|0.1555|TWO_SIDED|95.0|0.42|1.15||P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Cochran-Mantel-Haenszel||Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|BIRC Assessed||1.15|0.42|=0.1555
74010830|NCT03596866|147572959|SUPERIORITY||Odds Ratio (OR)|0.55|||=|0.0169|TWO_SIDED|95.0|0.33|0.9||P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Cochran-Mantel-Haenszel||Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Investigator Assessed||0.90|0.33|=0.0169
73879501|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.92||0.0008|TWO_SIDED|95.0|-10.28|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.71|-10.28|0.0008
73879502|NCT03192176|147297613|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.93||0.0889|TWO_SIDED|95.0|-7.1|0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.51|-7.10|0.0889
74010831|NCT03596866|147572962|SUPERIORITY||Odds Ratio (OR)|1.31|||=|0.6246|TWO_SIDED|95.0|0.44|3.84||P-value was from a Cochran-Mantel-Haenszel test stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.|Cochran-Mantel-Haenszel||Odds ratio was stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.|||3.84|0.44|=0.6246
74010832|NCT03596866|147572964|SUPERIORITY||||||=|0.0778||||||P-value from a 2-sided stratified Gray's test using the stratification factors (at randomization per IxRS): presence of intracranial CNS metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.|Gray's Test|P-value is for the event type: Intracranial Disease Progression without Prior Systemic Progression or Death.||||||=0.0778
74010833|NCT01961349|147572967|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
74041525|NCT03549117|147635314|SUPERIORITY||LS mean difference|-0.07||||0.9236|TWO_SIDED|95.0|-1.6|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.||1.45|-1.60|0.9236
74041526|NCT03549117|147635314|SUPERIORITY||LS mean difference|-0.05||||0.8756|TWO_SIDED|95.0|-0.87|0.75||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.||0.75|-0.87|0.8756
74041527|NCT03549117|147635315|SUPERIORITY||LS mean difference|0.02||||0.9314|TWO_SIDED|95.0|-0.38|0.42||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.42|-0.38|0.9314
74041528|NCT03549117|147635315|SUPERIORITY||LS mean difference|-0.05||||0.8005|TWO_SIDED|95.0|-0.45|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.35|-0.45|0.8005
74041529|NCT03549117|147635315|SUPERIORITY||LS mean difference|0.01||||0.9613|TWO_SIDED|95.0|-0.38|0.4||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.40|-0.38|0.9613
74093410|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.5|||||TWO_SIDED|95.0|-11.17|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.20|-11.17|
73879503|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.94||0.0023|TWO_SIDED|95.0|-9.76|-2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.13|-9.76|0.0023
73879504|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.94||0.0009|TWO_SIDED|95.0|-10.36|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.71|-10.36|0.0009
74010834|NCT01961349|147572967|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
74010835|NCT01961349|147572968|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
74010836|NCT01961349|147572968|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
74010837|NCT00896779|147572970|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
74010838|NCT00896779|147572970|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||t-test, 2 sided|||||||0.06
74010839|NCT02904915|147572971|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
74010840|NCT02904915|147572972|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
74010841|NCT02904915|147572973|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
74010842|NCT02971631|147572982|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|Paired analysis||||||0.008
74010843|NCT02971631|147572983|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Paired analysis||||||0.03
74010844|NCT02971631|147572984|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|Paired analysis||For meal consumption rate||||0.79
74041530|NCT03549117|147635315|SUPERIORITY||LS mean difference|-0.14||||0.4966|TWO_SIDED|95.0|-0.54|0.26||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.26|-0.54|0.4966
74041531|NCT03549117|147635316|SUPERIORITY||LS mean difference|0.03||||0.8775|TWO_SIDED|95.0|-0.39|0.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.45|-0.39|0.8775
73879505|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.98||0.0002|TWO_SIDED|95.0|-11.36|-3.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-3.58|-11.36|0.0002
74093411|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-10.0|||||TWO_SIDED|95.0|-15.31|-4.7|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||-4.70|-15.31|
74093412|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.5|||||TWO_SIDED|95.0|-9.55|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.46|-9.55|
74093413|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||TWO_SIDED|95.0|-4.23|2.52|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||2.52|-4.23|
74093414|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.3|||||TWO_SIDED|95.0|-6.35|-0.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||-0.40|-6.35|
74093415|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||TWO_SIDED|95.0|-5.44|0.33|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||0.33|-5.44|
74093416|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-3.67|4.8|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||4.80|-3.67|
74093417|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||TWO_SIDED|95.0|-2.38|6.28|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||6.28|-2.38|
74093418|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.4|||||TWO_SIDED|95.0|-3.06|5.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||5.82|-3.06|
74093419|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-3.34|5.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||5.08|-3.34|
74093420|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||TWO_SIDED|95.0|-6.39|1.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||1.18|-6.39|
74093421|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.4|||||TWO_SIDED|95.0|-7.45|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||0.46|-7.45|
74010845|NCT02971631|147572986|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|Paired analysis||Baseline||||0.20
74010846|NCT02971631|147572986|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|Paired analysis||Post-OGTT||||0.58
74010847|NCT02971631|147572986|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|Paired analysis||Pre-meal||||0.39
74010848|NCT02971631|147572986|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|Paired analysis||Post-meal||||0.20
74010849|NCT02971631|147572987|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|Paired analysis||Baseline||||0.26
74010850|NCT02971631|147572987|SUPERIORITY|||||||0.06||||||Paired analysis|t-test, 2 sided|||Post-OGTT||||0.06
74010851|NCT02971631|147572987|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|Paired analysis||Pre-meal||||0.95
74010852|NCT02971631|147572987|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|Paired analysis||Post-meal||||0.88
74010853|NCT02971631|147572988|SUPERIORITY|||||||1|||||||Other|0 events over whole study, no statistical test appropriate||||||1
74010854|NCT02971631|147572989|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
74093422|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.6|||||TWO_SIDED|95.0|-5.2|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||8.55|-5.20|
74093423|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.8|||||TWO_SIDED|95.0|-11.79|2.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||2.16|-11.79|
74093424|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.5|||||TWO_SIDED|95.0|-13.51|0.54|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||0.54|-13.51|
73879506|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.97||0.0255|TWO_SIDED|95.0|-8.3|-0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.55|-8.30|0.0255
73879507|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.94||0.0031|TWO_SIDED|95.0|-9.63|-1.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.98|-9.63|0.0031
73879508|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|1.93||0.0037|TWO_SIDED|95.0|-9.45|-1.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.85|-9.45|0.0037
74010855|NCT00736255|147572990|SUPERIORITY_OR_OTHER|||||||0.54|||||||Chi-squared|||"Null Hypothesis:LDX and NRT will not facilitate smoking cessation compared to NRT and placebo.~Alternate Hypothesis: LDX and NRT will facilitate smoking cessation compared to NRT and placebo.~This is a one tailed, proof of concept study so there is no formal power analysis, however if we see a signal for treatment effect, we would like to do further investigation by conducting a separate trial."||||0.54
74010856|NCT01360554|147573004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.195|TWO_SIDED|95.0|0.797|1.093||One-sided P-value.|1-sided stratified log-rank test|Stratified by epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG).|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS, baseline ECOG as stratification factors.|||1.093|0.797|0.195
74010857|NCT01360554|147573005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.037||||0.643|TWO_SIDED|95.0|0.848|1.268||One-sided P-value|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.268|0.848|0.643
74010858|NCT01360554|147573006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.899||||0.069|TWO_SIDED|95.0|0.78|1.035||Stratified by EGFR status, KRAS status, and baseline ECOG.|1-sided stratified log-rank test|One-sided P-value|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.|||1.035|0.780|0.069
74041532|NCT03549117|147635316|SUPERIORITY||LS mean difference|-0.06||||0.7747|TWO_SIDED|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.35|-0.47|0.7747
74041533|NCT03549117|147635316|SUPERIORITY||LS mean difference|0.04||||0.8535|TWO_SIDED|95.0|-0.39|0.47||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.47|-0.39|0.8535
74041534|NCT03549117|147635316|SUPERIORITY||LS mean difference|-0.06||||0.772|TWO_SIDED|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.35|-0.47|0.7720
74041535|NCT03549117|147635317|SUPERIORITY|||||||0.9258|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.9258
73887979|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|123.3||||0.0171|TWO_SIDED|95.0|22.3|224.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||224.3|22.3|0.0171
74010859|NCT01360554|147573007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.728|TWO_SIDED|95.0|0.881|1.267||One-sided P-value.|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.267|0.881|0.728
74010860|NCT01360554|147573008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026||||0.638|TWO_SIDED|95.0|0.887|1.188||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status, KRAS status, and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.|||1.188|0.887|0.638
74010861|NCT01360554|147573009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078||||0.775|TWO_SIDED|95.0|0.886|1.312||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.312|0.886|0.775
74041536|NCT03549117|147635317|SUPERIORITY|||||||0.2368|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.2368
74041537|NCT03549117|147635317|SUPERIORITY|||||||0.4432|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.4432
74041538|NCT03549117|147635317|SUPERIORITY|||||||0.9856|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.9856
74041539|NCT03549117|147635317|SUPERIORITY|||||||0.7854|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.7854
74010862|NCT01360554|147573017|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.9357||||||95.0|-4.278|0.407|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Global QoL. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||0.407|-4.278|
74010863|NCT01360554|147573017|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.8067||||||95.0|-1.312|2.926|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 cognitive functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.926|-1.312|
74010864|NCT01360554|147573017|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|0.73||||||95.0|-1.575|3.035|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 emotional functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.035|-1.575|
74010865|NCT01360554|147573017|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.5289||||||95.0|-0.756|3.814|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 physical functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.814|-0.756|
74010866|NCT01360554|147573017|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.2219||||||95.0|-1.975|4.419|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 role functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.419|-1.975|
74010867|NCT01360554|147573017|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.497||||||95.0|-4.575|1.581|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 social functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.581|-4.575|
74010868|NCT01360554|147573018|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.2851|||||TWO_SIDED|95.0|-2.416|4.986|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Appetite loss. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.986|-2.416|
74010869|NCT01360554|147573018|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-5.923|||||TWO_SIDED|95.0|-8.432|-3.414|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Constipation. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-3.414|-8.432|
74010870|NCT01360554|147573018|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|20.2564|||||TWO_SIDED|95.0|16.874|23.639|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Diarrhea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||23.639|16.874|
74010871|NCT01360554|147573018|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.5499|||||TWO_SIDED|95.0|-7.719|-1.381|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Dysponea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.381|-7.719|
74041540|NCT03549117|147635317|SUPERIORITY|||||||0.4141|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.4141
74010872|NCT01360554|147573018|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.6584|||||TWO_SIDED|95.0|-4.442|1.125|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Fatigue. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.125|-4.442|
74041541|NCT03549117|147635317|SUPERIORITY|||||||0.3028|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.3028
74041542|NCT03549117|147635317|SUPERIORITY|||||||0.3955|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.3955
74041543|NCT03549117|147635318|SUPERIORITY|||||||0.3826|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.3826
74010873|NCT01360554|147573018|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.1469||||||95.0|-3.056|2.762|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Financial Difficulties. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.762|-3.056|
74010874|NCT01360554|147573018|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.8711|||||TWO_SIDED|95.0|-7.998|-1.745|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Insomnia. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.745|-7.998|
74010875|NCT01360554|147573018|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.4924|||||TWO_SIDED|95.0|-2.485|1.5|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Nausea and Vomiting. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.500|-2.485|
74010876|NCT01360554|147573018|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.3096|||||TWO_SIDED|95.0|-2.646|3.265|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Pain. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.265|-2.646|
74010877|NCT01360554|147573019|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|2.6381||||||95.0|0.172|5.104|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Trouble Swallowing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||5.104|0.172|
74010878|NCT01360554|147573019|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.2504||||||95.0|-7.178|-1.322|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Coughing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.322|-7.178|
74010879|NCT01360554|147573019|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|-1.0764||||||95.0|-3.997|1.845|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Haemoptysis as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.845|-3.997|
74010880|NCT01360554|147573019|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|9.3545||||||95.0|6.211|12.497|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Sore Mouth as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||12.497|6.211|
74041544|NCT03549117|147635318|SUPERIORITY|||||||0.6251|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.6251
74041545|NCT03549117|147635318|SUPERIORITY|||||||0.2381|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.2381
74041546|NCT03549117|147635318|SUPERIORITY|||||||0.4245|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.4245
74041547|NCT03549117|147635318|SUPERIORITY|||||||0.8213|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.8213
74041548|NCT03549117|147635318|SUPERIORITY|||||||0.1823|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.1823
73879509|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|1.84||0.0316|TWO_SIDED|95.0|-7.59|-0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.35|-7.59|0.0316
74010881|NCT01360554|147573019|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.1762||||||95.0|-3.56|1.208|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Shortness of Breath as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.208|-3.560|
74041549|NCT03549117|147635318|SUPERIORITY|||||||0.7744|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.7744
74010882|NCT01360554|147573019|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.6378||||||95.0|-3.684|2.408|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Peripheral Neuropathy as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.408|-3.684|
74041550|NCT03549117|147635318|SUPERIORITY|||||||0.5811|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.5811
74041551|NCT00523614|147635330|NON_INFERIORITY_OR_EQUIVALENCE|"Size of the study adapted to the use of DNG/EE in female fertile age. Market share of DNG/EE of 13% in Germany. Assuming that 30% of women in the fertile age range were current users of OCs, a prevalence of current use of DNG/EE of about 4% was estimated.~Based on these data the number of cases needed to exclude a twofold increased VTE risk was estimated at about 500-700 cases (based on four controls per case)."|Odds Ratio (OR)|0.89|||<|0.05||95.0|0.57|1.39|||Regression, Logistic|||Null hypothesis: OR ≥ 2 (VTE of DNG/EE vs. other low-dose COC)||1.39|0.57|<0.05
74041552|NCT03296787|147635353|SUPERIORITY|TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.7265|||||||ANOVA|||||||0.7265
74041553|NCT03296787|147635353|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.9839|||||||ANOVA|||||||0.9839
74041554|NCT03296787|147635353|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.9393|||||||ANOVA|||||||0.9393
74041555|NCT03296787|147635353|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.1321|||||||ANOVA|||||||0.1321
74041556|NCT03296787|147635354|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.36|||||||ANOVA|||||||0.3600
74041557|NCT03296787|147635354|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0816|||||||ANOVA|||||||0.0816
74041558|NCT03296787|147635354|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.2686|||||||ANOVA|||||||0.2686
74041559|NCT03296787|147635354|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0059|||||||ANOVA|||||||0.0059
74041560|NCT03296787|147635355|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0998|||||||ANOVA|||||||0.0998
74041561|NCT03296787|147635355|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0155|||||||ANOVA|||||||0.0155
74041562|NCT03296787|147635355|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0916|||||||ANOVA|||||||0.0916
74041563|NCT03296787|147635355|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0014|||||||ANOVA|||||||0.0014
74093425|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|3.1|||||TWO_SIDED|95.0|-0.84|7.13|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||7.13|-0.84|
74010883|NCT01360554|147573019|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.3637||||||95.0|-4.546|1.819|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Alopecia as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.819|-4.546|
74041564|NCT03296787|147635356|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0038|||||||ANOVA|||||||0.0038
74041565|NCT03296787|147635356|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0004|||||||ANOVA|||||||0.0004
74041566|NCT03296787|147635356|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0389|||||||ANOVA|||||||0.0389
74041567|NCT03296787|147635356|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0011|||||||ANOVA|||||||0.0011
74041568|NCT01626989|147635368|NON_INFERIORITY_OR_EQUIVALENCE|Friedman Test comparing all 3 nights||||||0.001|||||||nonparametric Wilcoxon Signed Rank test|||||||.001
74041569|NCT02437487|147635382|SUPERIORITY||Relative Risk|1.2217|||||TWO_SIDED|95.0|0.7919|1.8849||||||||1.8849|0.7919|
74041570|NCT02437487|147635384|SUPERIORITY||Relative Risk|1.2624|||||TWO_SIDED|95.0|0.7668|2.0785||||||||2.0785|0.7668|
74041571|NCT02437487|147635385|SUPERIORITY||Relative Risk|1.2217|||||TWO_SIDED|95.0|0.7919|1.8849||||||||1.8849|0.7919|
74041572|NCT02437487|147635386|SUPERIORITY||Relative Risk|1.0878|||||TWO_SIDED|95.0|0.7383|1.6029||||||||1.6029|0.7383|
74041573|NCT01230749|147635407|SUPERIORITY_OR_OTHER||Difference in LSM|-27.4||||0.006|TWO_SIDED|95.0|-46.792|-8.008|||ANCOVA|||||-8.008|-46.792|0.006
74041574|NCT01230749|147635407|SUPERIORITY_OR_OTHER||Difference in LSM|-20.47||||0.038|TWO_SIDED|95.0|-39.801|-1.142|||ANCOVA|||||-1.142|-39.801|0.038
74041575|NCT01230749|147635407|SUPERIORITY_OR_OTHER||Difference in LSM|-13.24||||0.178|TWO_SIDED|95.0|-32.635|6.151|||ANCOVA|||||6.151|-32.635|0.178
74041576|NCT01230749|147635408|SUPERIORITY_OR_OTHER||Difference in LSM|-28.28||||0.005|TWO_SIDED|95.0|-47.606|-8.957|||ANCOVA|||||-8.957|-47.606|0.005
74041577|NCT01230749|147635408|SUPERIORITY_OR_OTHER||Difference in LSM|-21.97||||0.025|TWO_SIDED|95.0|-41.154|-2.786|||ANCOVA|||||-2.786|-41.154|0.025
74041578|NCT01230749|147635408|SUPERIORITY_OR_OTHER||Difference in LSM|-17.71||||0.069|TWO_SIDED|95.0|-36.86|1.431|||ANCOVA|||||1.431|-36.860|0.069
74041579|NCT01230749|147635409|SUPERIORITY_OR_OTHER||Difference in LSM|2.76||||0.628|TWO_SIDED|95.0|-8.542|14.054|||ANCOVA|||||14.054|-8.542|0.628
74041580|NCT01230749|147635409|SUPERIORITY_OR_OTHER||Difference in LSM|13.7||||0.018|TWO_SIDED|95.0|2.392|25.008|||ANCOVA|||||25.008|2.392|0.018
74041581|NCT01230749|147635409|SUPERIORITY_OR_OTHER||Difference in LSM|5.87||||0.303|TWO_SIDED|95.0|-5.417|17.148|||ANCOVA|||||17.148|-5.417|0.303
74041582|NCT01230749|147635410|SUPERIORITY_OR_OTHER||Difference in LSM|-1.86||||0.041|TWO_SIDED|95.0|-3.634|-0.082|||ANCOVA|||||-0.082|-3.634|0.041
74041583|NCT01230749|147635410|SUPERIORITY_OR_OTHER||Difference in LSM|-0.26||||0.769|TWO_SIDED|95.0|-2.033|1.509|||ANCOVA|||||1.509|-2.033|0.769
74041584|NCT01230749|147635410|SUPERIORITY_OR_OTHER||Difference in LSM|-0.69||||0.444|TWO_SIDED|95.0|-2.463|1.091|||ANCOVA|||||1.091|-2.463|0.444
74041585|NCT01230749|147635411|SUPERIORITY_OR_OTHER||GMR mulitplied by 100 percent|95.1||||0.774|TWO_SIDED|90.0|71.031|127.324|||ANCOVA|||||127.324|71.031|0.774
74041586|NCT01230749|147635411|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|89.9||||0.555|TWO_SIDED|90.0|66.567|121.403|||ANCOVA|||||121.403|66.567|0.555
74041587|NCT01230749|147635412|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|100.17||||0.968|TWO_SIDED|90.0|93.217|107.647|||ANCOVA|||||107.647|93.217|0.968
74041588|NCT01230749|147635412|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|101.18||||0.785|TWO_SIDED|90.0|94.179|108.7|||ANCOVA|||||108.700|94.179|0.785
74041589|NCT01230749|147635413|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|133.27||||0.097|TWO_SIDED|90.0|100.275|177.115|||ANCOVA|||||177.115|100.275|0.097
74041590|NCT01230749|147635413|SUPERIORITY_OR_OTHER||GMR mulitplied by 100 percent|101.82||||0.917|TWO_SIDED|90.0|76.26|135.942|||ANCOVA|||||135.942|76.260|0.917
74041591|NCT01230749|147635414|SUPERIORITY_OR_OTHER||Difference in LSM|0.46||||0.295|TWO_SIDED|95.0|-0.408|1.323|||ANCOVA|||||1.323|-0.408|0.295
74041592|NCT01230749|147635414|SUPERIORITY_OR_OTHER||Difference in LSM|0.03||||0.941|TWO_SIDED|95.0|-0.838|0.904|||ANCOVA|||||0.904|-0.838|0.941
74041593|NCT01230749|147635414|SUPERIORITY_OR_OTHER||Difference in LSM|1.02||||0.022|TWO_SIDED|95.0|0.15|1.892|||ANCOVA|||||1.892|0.150|0.022
74041594|NCT00713284|147635431|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
74041595|NCT03127852|147635432|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Poststudy between-group comparison of SF-36 physical component summary score.||||.48
74041596|NCT03127852|147635432|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||Poststudy between-group comparison of SF-36 mental component summary score.||||.73
74041597|NCT03127852|147635433|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of hospital visits.||||.02
74041598|NCT03127852|147635433|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported emergency department visits.||||.12
74041599|NCT03127852|147635433|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of clinic visits.||||.39
74041600|NCT03127852|147635433|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of family physician visits.||||.28
74041601|NCT03127852|147635434|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI maintenance sub-scale.||||.74
74041602|NCT03127852|147635434|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI management sub-scale.||||.67
74041603|NCT03127852|147635434|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI confidence sub-scale.||||.92
74041604|NCT03127852|147635435|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ total score.||||.67
74041605|NCT03127852|147635435|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ physical domain score.||||.43
74041606|NCT03127852|147635435|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ emotional domain score.||||.64
74041607|NCT03127852|147635436|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||Poststudy between-group comparison of HADS anxiety sub-scale.||||.06
74041608|NCT03127852|147635436|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Poststudy between-group comparison of HADS depression sub-scale.||||.77
74041609|NCT03127852|147635437|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Poststudy between-group comparison of SEMCD6.||||.13
74041610|NCT01432457|147635446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.57||||0.006|TWO_SIDED|95.0|0.44|2.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.69|0.44|0.006
74010884|NCT01360554|147573019|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.2163||||||95.0|-3.885|1.452|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Chest as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.452|-3.885|
74010885|NCT01360554|147573019|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.1475||||||95.0|-3.902|1.607|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Arm or Shoulder as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.607|-3.902|
74010886|NCT01360554|147573019|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.0687||||||95.0|-4.488|2.351|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain Other Parts as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.351|-4.488|
74010887|NCT01360554|147573019|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.0322||||||95.0|-4.847|4.911|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Any Med for Pain as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.911|-4.847|
74010888|NCT01360554|147573020|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.3886||||||95.0|-2.413|1.636|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for EQ-5D VAS. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.636|-2.413|
74010889|NCT00111800|147573033|SUPERIORITY||Mean Difference (Net)|-0.28||||0.061|TWO_SIDED|95.0|-0.58|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.58|0.061
74093426|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-3.14|4.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||4.11|-3.14|
74093427|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||TWO_SIDED|95.0|-6.72|1.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.40|-6.72|
74093428|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||TWO_SIDED|95.0|-0.87|3.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||3.02|-0.87|
74010890|NCT00111800|147573033|SUPERIORITY||Mean Difference (Net)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.82|-0.24|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.24|-0.82|<0.001
74093429|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.62|1.71|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.71|-1.62|
74093430|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-3.0|0.92|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||0.92|-3.00|
74093431|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||TWO_SIDED|95.0|-0.62|4.67|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||4.67|-0.62|
74093432|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.67|1.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||1.55|-2.67|
74093433|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||TWO_SIDED|95.0|-5.11|-0.01|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||-0.01|-5.11|
74010891|NCT00111800|147573033|SUPERIORITY||Mean Difference (Net)|-0.45||||0.002|TWO_SIDED|95.0|-0.74|-0.16|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.16|-0.74|0.002
74010892|NCT00111800|147573033|SUPERIORITY||Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.09|-0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.50|-1.09|<0.001
74010893|NCT00111800|147573033|SUPERIORITY||Mean Difference (Net)|-0.84|||<|0.001|TWO_SIDED|95.0|-1.13|-0.55|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.55|-1.13|<0.001
74010894|NCT00111800|147573035|SUPERIORITY||Mean Difference (Net)|-0.4||||0.306|TWO_SIDED|95.0|-1.18|0.37|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.37|-1.18|0.306
74010895|NCT00111800|147573035|SUPERIORITY||Mean Difference (Net)|-0.8||||0.039|TWO_SIDED|95.0|-1.56|-0.04|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.04|-1.56|0.039
74010896|NCT00111800|147573035|SUPERIORITY||Mean Difference (Net)|-0.58||||0.13|TWO_SIDED|95.0|-1.34|0.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.17|-1.34|0.130
73887980|NCT01746901|147309528|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3||||0.0016|TWO_SIDED|95.0|-3.7|-0.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.9|-3.7|0.0016
74010897|NCT00111800|147573035|SUPERIORITY||Mean Difference (Net)|-1.46|||<|0.001|TWO_SIDED|95.0|-2.23|-0.69|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.69|-2.23|<0.001
74010898|NCT00111800|147573035|SUPERIORITY||Mean Difference (Net)|-1.22||||0.002|TWO_SIDED|95.0|-1.99|-0.46|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.46|-1.99|0.002
74010899|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|0.92||||0.909|TWO_SIDED|95.0|0.21|3.95|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.95|0.21|0.909
74041611|NCT01432457|147635446|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.96|||<|0.001|TWO_SIDED|95.0|0.84|3.08||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||3.08|0.84|< 0.001
74041612|NCT01432457|147635447|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.36||||0.014|TWO_SIDED|95.0|0.28|2.45|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.45|0.28|0.014
74041613|NCT01432457|147635447|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.67||||0.002|TWO_SIDED|95.0|0.59|2.74|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.74|0.59|0.002
74041614|NCT01432457|147635448|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||||0.029
74041615|NCT01432457|147635448|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||||< 0.001
74041616|NCT01432457|147635449|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2||||0.009|TWO_SIDED|95.0|0.05|0.34|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.34|0.05|0.009
74093434|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.45|2.1|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||2.10|-0.45|
73879510|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.84||0.0036|TWO_SIDED|95.0|-9.02|-1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.78|-9.02|0.0036
73879511|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.85||0.0004|TWO_SIDED|95.0|-10.23|-2.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.94|-10.23|0.0004
73879512|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.88||0.0001|TWO_SIDED|95.0|-10.93|-3.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-3.54|-10.93|0.0001
74010900|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|1.15||||0.852|TWO_SIDED|95.0|0.27|4.92|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.92|0.27|0.852
74010901|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|1.2||||0.795|TWO_SIDED|95.0|0.3|4.83|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.83|0.30|0.795
74041617|NCT01432457|147635449|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.28|||<|0.001|TWO_SIDED|95.0|0.13|0.43|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.43|0.13|< 0.001
74041618|NCT01432457|147635450|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.17||||0.062|TWO_SIDED|95.0|-0.01|0.34|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.34|-0.01|0.062
74041619|NCT01432457|147635450|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.22||||0.014|TWO_SIDED|95.0|0.04|0.39|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.39|0.04|0.014
74041620|NCT01432457|147635451|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.242||||0.198|TWO_SIDED|95.0|0.893|1.726|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.726|0.893|0.198
74041621|NCT01432457|147635451|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.378||||0.054|TWO_SIDED|95.0|0.995|1.91|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.910|0.995|0.054
74041622|NCT01432457|147635452|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.105||||0.615|TWO_SIDED|95.0|0.749|1.631|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.631|0.749|0.615
74041623|NCT01432457|147635452|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.412||||0.072|TWO_SIDED|95.0|0.969|2.057|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.057|0.969|0.072
74093435|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.75|1.58|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.58|-0.75|
74010902|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|2.68||||0.135|TWO_SIDED|95.0|0.74|9.77|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.77|0.74|0.135
74041624|NCT01432457|147635453|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09||||0.837|TWO_SIDED|95.0|-0.98|0.8||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.80|-0.98|0.837
74041625|NCT01432457|147635453|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.32||||0.471|TWO_SIDED|95.0|-1.19|0.55||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.55|-1.19|0.471
74093436|NCT00444457|147738353|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.86|1.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.05|-1.86|
73879513|NCT03192176|147297613|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.87||0.0502|TWO_SIDED|95.0|-7.37|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.00|-7.37|0.0502
73879514|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.85||0.0025|TWO_SIDED|95.0|-9.28|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.99|-9.28|0.0025
74010903|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|3.24||||0.085|TWO_SIDED|95.0|0.85|12.37|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||12.37|0.85|0.085
74010904|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|1.1||||0.866|TWO_SIDED|95.0|0.36|3.36|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.36|0.36|0.866
74010905|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|1.99||||0.202|TWO_SIDED|95.0|0.69|5.76|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.76|0.69|0.202
74010906|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|1.04||||0.941|TWO_SIDED|95.0|0.35|3.13|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.13|0.35|0.941
74010907|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|2.15||||0.152|TWO_SIDED|95.0|0.76|6.13|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.13|0.76|0.152
74010908|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|3.24||||0.032|TWO_SIDED|95.0|1.11|9.52|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.52|1.11|0.032
74010909|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|0.46||||0.198|TWO_SIDED|95.0|0.14|1.5|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||1.50|0.14|0.198
74041626|NCT02574481|147635454|NON_INFERIORITY|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions.|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is \<0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning|||||||<0.0001
74041627|NCT02574481|147635455|NON_INFERIORITY|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions..|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is \<0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning|||||||<0.0001
74041628|NCT01281189|147635474|SUPERIORITY||LS Mean Difference (Final Values)|2.91||||0.8568|TWO_SIDED|95.0|-28.751|34.576|||ANCOVA|Includes treatment as a fixed effect and adjusts for baseline ALSFRS-R total score, duration from sx onset, site of onset, and use of riluzole.||||34.576|-28.751|0.8568
74010910|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|1.43||||0.481|TWO_SIDED|95.0|0.53|3.85|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.85|0.53|0.481
74010911|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|1.01||||0.991|TWO_SIDED|95.0|0.36|2.78|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||2.78|0.36|0.991
74010912|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|3.65||||0.008|TWO_SIDED|95.0|1.41|9.48|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.48|1.41|0.008
74010913|NCT00111800|147573037|SUPERIORITY||Odds Ratio (OR)|2.0||||0.161|TWO_SIDED|95.0|0.76|5.24|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c reduction \>=0.7%. A closed test procedure was used,P an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.24|0.76|0.161
74010914|NCT00111800|147573038|SUPERIORITY||Odds Ratio (OR)|1.77||||0.38|TWO_SIDED|95.0|0.5|6.3|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.30|0.50|0.380
74010915|NCT00111800|147573038|SUPERIORITY||Odds Ratio (OR)|2.57||||0.145|TWO_SIDED|95.0|0.72|9.11|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.11|0.72|0.145
74093437|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.1|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||0.13|-0.10|
74093438|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.29|||||TWO_SIDED|95.0|-0.41|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.17|-0.41|
74010916|NCT00111800|147573038|SUPERIORITY||Odds Ratio (OR)|1.09||||0.906|TWO_SIDED|95.0|0.26|4.62|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.62|0.26|0.906
74010917|NCT00111800|147573038|SUPERIORITY||Odds Ratio (OR)|1.56||||0.509|TWO_SIDED|95.0|0.41|5.91|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.91|0.41|0.509
74010918|NCT00111800|147573038|SUPERIORITY||Odds Ratio (OR)|3.14||||0.077|TWO_SIDED|95.0|0.89|11.14|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||11.14|0.89|0.077
74010919|NCT00111800|147573038|SUPERIORITY||Odds Ratio (OR)|1.9||||0.254|TWO_SIDED|95.0|0.63|5.72|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.72|0.63|0.254
74010920|NCT00111800|147573038|SUPERIORITY||Odds Ratio (OR)|1.59||||0.396|TWO_SIDED|95.0|0.55|4.62|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.62|0.55|0.396
74010921|NCT00111800|147573038|SUPERIORITY||Odds Ratio (OR)|1.35||||0.59|TWO_SIDED|95.0|0.45|4.0|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.00|0.45|0.590
74010922|NCT00111800|147573038|SUPERIORITY||Odds Ratio (OR)|3.24||||0.026|TWO_SIDED|95.0|1.15|9.13|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.13|1.15|0.026
74010923|NCT00111800|147573038|SUPERIORITY||Odds Ratio (OR)|3.0||||0.034|TWO_SIDED|95.0|1.08|8.3|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||8.30|1.08|0.034
74041629|NCT01281189|147635475|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8375|TWO_SIDED|95.0|0.75|1.427|||Cox Proportional Hazards model|Adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole.|||Hazard Ratio (HR) (Dex/PBO)|1.427|0.750|0.8375
74041630|NCT01281189|147635476|SUPERIORITY||LS Mean Difference (Net)|0.076||||0.9019|TWO_SIDED|95.0|-1.128|1.28|||mixed-effects repeated-measures model|Mixed-effects repeated-measures model with treatment, visit, treatment-by visit interaction, baseline ALSFRS-R score, baseline-by-visit interaction|The mixed-effects repeated-measures model also adjusted for the following covariates: duration from symptom onset, site of onset, and use of riluzole.|||1.280|-1.128|0.9019
73887981|NCT01746901|147309528|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.0105|TWO_SIDED|95.0|0.4|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|0.4|0.0105
74010924|NCT00111800|147573039|SUPERIORITY||Mean Difference (Net)|-14.9||||0.057||95.0|-30.2|0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.5|-30.2|0.057
74010925|NCT00111800|147573039|SUPERIORITY||Mean Difference (Net)|-22.4||||0.003||95.0|-37.1|-7.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-7.6|-37.1|0.003
74010926|NCT00111800|147573039|SUPERIORITY||Mean Difference (Net)|-29.2|||<|0.001||95.0|-43.9|-14.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-14.5|-43.9|<0.001
74010927|NCT00111800|147573039|SUPERIORITY||Mean Difference (Net)|-39.6|||<|0.001|TWO_SIDED|95.0|-54.6|-24.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-24.6|-54.6|<0.001
74010928|NCT00111800|147573039|SUPERIORITY||Mean Difference (Net)|-38.9|||<|0.001|TWO_SIDED|95.0|-53.8|-23.9|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-23.9|-53.8|<0.001
74041631|NCT01281189|147635477|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7715|TWO_SIDED|95.0|0.801|1.348|||Cox Proportional Hazards model|Adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole||||1.348|0.801|0.7715
74041632|NCT01281189|147635478|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9033|TWO_SIDED|95.0|0.745|1.298|||Cox Proportional Hazards model|adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole||||1.298|0.745|0.9033
74041633|NCT01281189|147635479|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.772|TWO_SIDED|95.0|0.789|1.192|||Cox Proportional Hazards model||Hazard ratio (Dex/PBO)|||1.192|0.789|0.7720
74041634|NCT01090102|147635514|SUPERIORITY_OR_OTHER|||||||0.63||||||Significant at p\<0.05|t-test, 2 sided|||||||0.63
74041635|NCT01090102|147635515|SUPERIORITY_OR_OTHER|||||||0.77||||||significant at p\<0.05|t-test, 2 sided|||||||0.77
73879515|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.1|STANDARD_ERROR_OF_MEAN|1.84||0.0063|TWO_SIDED|95.0|-8.67|-1.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.44|-8.67|0.0063
73879516|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.9||0.0117|TWO_SIDED|95.0|-8.58|-1.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.08|-8.58|0.0117
73879517|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.91||0.0047|TWO_SIDED|95.0|-9.17|-1.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.67|-9.17|0.0047
74010929|NCT00111800|147573041|SUPERIORITY||Mean Difference (Net)|-8.51||||0.489|TWO_SIDED|95.0|-32.66|15.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for fasting serum insulin.|Placebo versus DEN 2.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||15.65|-32.66|0.489
74010930|NCT00111800|147573041|SUPERIORITY||Mean Difference (Net)|14.18||||0.237|TWO_SIDED|95.0|-9.37|37.72|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for fasting serum insulin.|Placebo versus DEN 7.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||37.72|-9.37|0.237
74010931|NCT00111800|147573041|SUPERIORITY||Mean Difference (Net)|7.31||||0.534||95.0|-15.79|30.42|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for fasting serum insulin.|Placebo versus DEN 15 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||30.42|-15.79|0.534
74010932|NCT00111800|147573041|SUPERIORITY||Mean Difference (Net)|5.27||||0.665|TWO_SIDED|95.0|-18.64|29.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for fasting serum insulin.|Placebo versus DEN 30 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||29.17|-18.64|0.665
74010933|NCT00111800|147573041|SUPERIORITY||Mean Difference (Net)|12.74||||0.295|TWO_SIDED|95.0|-11.18|36.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for fasting serum insulin.|Placebo versus DEN 45 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||36.65|-11.18|0.295
74093439|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.31|||||TWO_SIDED|95.0|-0.43|-0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.19|-0.43|
73879518|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.92||0.0003|TWO_SIDED|95.0|-10.8|-3.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.23|-10.80|0.0003
73879519|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.94|<|0.0001|TWO_SIDED|95.0|-11.51|-3.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.86|-11.51|<0.0001
74010934|NCT00111800|147573041|SUPERIORITY||Mean Difference (Net)|3.31||||0.327|TWO_SIDED|95.0|-3.32|9.94|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for pro-insulin.|Placebo versus DEN 2.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.94|-3.32|0.327
74010935|NCT00111800|147573041|SUPERIORITY||Mean Difference (Net)|3.06||||0.345|TWO_SIDED|95.0|-3.31|9.44|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for pro-insulin.|Placebo versus DEN 7.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.44|-3.31|0.345
74010936|NCT00111800|147573041|SUPERIORITY||Mean Difference (Net)|-0.35||||0.914|TWO_SIDED|95.0|-6.7|6.0|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for pro-insulin.|Placebo versus DEN 15 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.00|-6.70|0.914
74010937|NCT00111800|147573041|SUPERIORITY||Mean Difference (Net)|-2.21||||0.504|TWO_SIDED|95.0|-8.71|4.29|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for pro-insulin.|Placebo versus DEN 30 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.29|-8.71|0.504
74093440|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.30|0.06|
74093441|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.12|||||TWO_SIDED|95.0|0.0|0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.23|-0.00|
74093442|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.18|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.06|-0.18|
74041636|NCT03518034|147635517|NON_INFERIORITY|Noninferiority margin in terms of HR is 1.5.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.78|1.17|||||HR of AndroGel to placebo and 95% CI were estimated from Cox proportional-hazards regression model, with adjustment for pre-existing CVD.|The hazard ratio (HR) and 2-sided 95% confidence interval (CI) were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing cardiovascular disease (CVD) status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of MACE. If a subject does not experience a MACE during the study, the time is right-censored at the time of participant's last available follow-up observation.||1.17|0.78|
74041637|NCT03518034|147635519|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.86|1.21|||||HR of AndroGel to placebo and 2-sided 95% CI were estimated from a Cox proportional-hazards regression model with adjustment of pre-existing CVD status.|The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of CV safety endpoint. If a participant does not experience a CV safety endpoint during the study, the time is right-censored at the time of participant's last available follow-up observation.||1.21|0.86|
74041638|NCT03518034|147635520|SUPERIORITY||Hazard Ratio (HR)|1.62|||||TWO_SIDED|95.0|0.39|6.77|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior cardiovascular disease (CVD).|The high grade prostate cancer endpoint was analyzed using a discrete time proportional hazard regression model with event time intervals based on scheduled visits, and adjusting for pre-existing CVD status. The HR of AndroGel to Placebo and its 2-sided 95% CI were provided.||6.77|0.39|
74041639|NCT03518034|147635521|SUPERIORITY|||||||0.011||||||P-value is derived from the omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using linear mixed regression model.|linear mixed regression model|Omnibus likelihood-ratio chi-square test from linear mixed regression model||A linear mixed regression model was used to analyze the change in PDQ-Q4 from baseline to months 6, 12, and 24, with the dependent variable being the change in PDQ-Q4 score. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CVD status. An unstructured covariance matrix was used to account for correlations among repeated measures within-subject.||||0.011
74093443|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.09|-0.13|
74093444|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.15|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.07|-0.15|
73879520|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.94||0.0083|TWO_SIDED|95.0|-8.97|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-1.34|-8.97|0.0083
74041640|NCT03518034|147635521|SUPERIORITY||LS Mean of Difference|0.49|||||TWO_SIDED|95.0|0.19|0.79|||||LS mean difference (AndroGel - Placebo) at month 6 was derived from linear mixed regression model.|Month 6 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.79|0.19|
74093445|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.09|-0.13|
74093446|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.19|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.06|-0.19|
74093447|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.17|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.08|-0.17|
74093448|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.11|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.15|-0.11|
74093449|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.12|||||TWO_SIDED|95.0|-0.25|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.00|-0.25|
74010938|NCT00111800|147573041|SUPERIORITY||Mean Difference (Net)|2.75||||0.403|TWO_SIDED|95.0|-3.71|9.22|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for pro-insulin.|Placebo versus DEN 45 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.22|-3.71|0.403
74093450|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.24|||||TWO_SIDED|95.0|-0.37|-0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.12|-0.37|
73879521|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.92||0.0011|TWO_SIDED|95.0|-10.1|-2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.56|-10.10|0.0011
74010939|NCT00111800|147573044|SUPERIORITY||Mean Difference (Net)|0.03||||0.286|TWO_SIDED|95.0|-0.02|0.08|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.08|-0.02|0.286
74010940|NCT00111800|147573044|SUPERIORITY||Mean Difference (Net)|-0.02||||0.457|TWO_SIDED|95.0|-0.07|0.03|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.03|-0.07|0.457
74010941|NCT00111800|147573044|SUPERIORITY||Mean Difference (Net)|-0.04||||0.136|TWO_SIDED|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.09|0.136
74010942|NCT00111800|147573044|SUPERIORITY||Mean Difference (Net)|-0.06||||0.021|TWO_SIDED|95.0|-0.11|-0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.01|-0.11|0.021
74010943|NCT00111800|147573044|SUPERIORITY||Mean Difference (Net)|-0.04||||0.094|TWO_SIDED|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.09|0.094
74010944|NCT03901105|147573060|OTHER||Risk Ratio (RR)|1.36||||0.0313|TWO_SIDED|95.0|1.028|1.785||A priori threshold was two-sided 0.05.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline CDR-SB score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.785|1.028|0.0313
74010945|NCT03901105|147573061|OTHER||Risk Ratio (RR)|1.35||||0.0833|TWO_SIDED|95.0|0.962|1.886||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for MMSE CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.886|0.962|.0833
74010946|NCT03901105|147573061|OTHER||Risk Ratio (RR)|1.77||||0.0141|TWO_SIDED|95.0|1.122|2.796||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for ADAS-Cog11 CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||2.796|1.122|.0141
74010947|NCT03901105|147573061|OTHER||Risk Ratio (RR)|1.32||||0.0639|TWO_SIDED|95.0|0.984|1.776||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for FAQ CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.776|0.984|.0639
74010948|NCT03901105|147573061|OTHER||Risk Ratio (RR)|1.28||||0.2814|TWO_SIDED|95.0|0.815|2.02||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for CDR Global CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||2.020|0.815|.2814
74010949|NCT03901105|147573062|OTHER|||||||0.0305||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between CDR-SB least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||.0305
74010950|NCT03901105|147573062|OTHER||||||<|0.0001||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between MMSE least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||<0.0001
74093451|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.12|||||TWO_SIDED|95.0|-0.25|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.01|-0.25|
74093452|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.18|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||0.11|-0.18|
74093453|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.37|||||TWO_SIDED|95.0|-0.51|-0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.22|-0.51|
74010951|NCT03901105|147573062|OTHER|||||||0.0006||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between ADAS-Cog11 least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||0.0006
74041641|NCT03518034|147635521|SUPERIORITY||LS Mean of Difference|0.47|||||TWO_SIDED|95.0|0.11|0.83|||||LS mean difference (AndroGel - Placebo) at month 12 was derived from linear mixed regression model.|Month 12 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.83|0.11|
74041642|NCT03518034|147635521|SUPERIORITY||LS Mean of Difference|0.48|||||TWO_SIDED|95.0|-0.01|0.96|||||LS mean difference (AndroGel - Placebo) at month 24 was derived from linear mixed regression model.|Month 24 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.96|-0.01|
74041643|NCT03518034|147635522|SUPERIORITY||Risk Ratio (RR)|1.92|||||TWO_SIDED|95.0|0.96|3.86||||||Month 6 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||3.86|0.96|
74041644|NCT03518034|147635522|SUPERIORITY||Risk Ratio (RR)|1.52|||||TWO_SIDED|95.0|0.64|3.63||||||Month 12 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||3.63|0.64|
74093454|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.33|||||TWO_SIDED|95.0|-0.47|-0.2|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.20|-0.47|
74010952|NCT03901105|147573062|OTHER|||||||0.0097||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between FAQ least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||0.0097
74010953|NCT00253643|147573064|SUPERIORITY_OR_OTHER|||||||0.1521|TWO_SIDED|||||Utilized a priori threshold for statistical significance of 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on FAS summary scores||||0.1521
74010954|NCT00253643|147573065|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED|||||A priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect of time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on Ki-67||||0.1573
74010955|NCT01549275|147573066|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Chi-squared|degrees of freedom =1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cells between two groups.||||< 0.005
74010956|NCT01549275|147573066|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured HCC cells with or without concomitant cancer-associated fibroblasts between two groups.||||< 0.005
74010957|NCT01549275|147573066|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cancer-associated fibroblasts alone between two groups.||||> 0.1
74041645|NCT03518034|147635522|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.42|1.94||||||Month 24 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||1.94|0.42|
74041646|NCT03518034|147635522|SUPERIORITY|||||||0.197||||||The omnibus test p value is a test of the null hypothesis of no difference between AndroGel and placebo groups across all time points.|GEE Poisson regression model|||Risk ratio of remission of LG-PDD in the TRT versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||||0.197
74093455|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.17|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.11|-0.17|
74093456|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.08|||||TWO_SIDED|95.0|-0.07|0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.22|-0.07|
74010958|NCT01549275|147573067|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||1
73879522|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.9||0.0017|TWO_SIDED|95.0|-9.77|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.29|-9.77|0.0017
73879523|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.86||0.0119|TWO_SIDED|95.0|-8.37|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.05|-8.37|0.0119
73879524|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0015|TWO_SIDED|95.0|-9.61|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.29|-9.61|0.0015
73879525|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.38|-3.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.99|-11.38|<0.0001
74010959|NCT01549275|147573067|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.032
74010960|NCT01549275|147573067|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.048
74010961|NCT01549275|147573067|SUPERIORITY_OR_OTHER|||||||0.176|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.176
74010962|NCT01549275|147573067|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative HCC cultured cells.||||0.021
74010963|NCT01549275|147573067|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.129
74010964|NCT03448068|147573068|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
74010965|NCT03448068|147573069|SUPERIORITY|||||||0.2252|||||||t-test, 2 sided|||||||0.2252
74010966|NCT03448068|147573070|SUPERIORITY|||||||0.061|||||||t-test, 2 sided|||||||0.0610
73879526|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-11.33|-3.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.87|-11.33|<0.0001
73879527|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.89||0.0051|TWO_SIDED|95.0|-9.07|-1.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.62|-9.07|0.0051
74010967|NCT03448068|147573071|SUPERIORITY|||||||0.272|||||||t-test, 2 sided|||||||0.2720
74010968|NCT03448068|147573072|SUPERIORITY|||||||0.7298|||||||Chi-squared|||Nausea 1st 12 hours for Ketamine Therapy vs Standard Therapy||||0.7298
74010969|NCT03448068|147573072|SUPERIORITY|||||||0.1058|||||||Chi-squared|||Nausea 2nd 12 hours for Ketamine Therapy vs Standard Therapy||||0.1058
74010970|NCT03448068|147573072|SUPERIORITY|||||||1|||||||Chi-squared|||Nausea 2nd 24 hours for Ketamine Therapy vs Standard Therapy||||1.000
74010971|NCT03448068|147573073|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
74010972|NCT00365456|147573076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.012|STANDARD_ERROR_OF_MEAN|1.0045||0.01|TWO_SIDED|95.0|1.003|1.021||No multiplicity correction of the significance level was performed as only one primary endpoint was planned.|ANCOVA|Estimation allowing for unequal variance in the two treatment groups and robust estimates for the standard errors were obtained.||An analysis of covariance (ANCOVA) model was used including treatment group, stratum and pooled centre as fixed effects and log (BMD at Baseline III (month 24)) as a covariate (log-normally distributed data assumed). Least square mean change from baseline III (month 24), 95% confidence interval and p-value for the treatment effect (PTH (1-84) vs. Risedronate) was calculated. Superiority was claimed if lower limit of the interval was above 1. Results were back-transformed from the log scale.||1.021|1.003|0.010
74093457|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.11|||||TWO_SIDED|95.0|-0.03|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.25|-0.03|
74093458|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.07|||||TWO_SIDED|95.0|-0.2|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.06|-0.20|
74093459|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.21|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.03|-0.21|
74010973|NCT01131676|147573078|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|95.02|0.74|0.99||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|Primary objective was to establish the non-inferiority of All empagliflozin relative to placebo for time to first 3-point MACE. A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||0.99|0.74|<0.0001
74010974|NCT01131676|147573078|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0382|TWO_SIDED|95.02|0.74|0.99||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.99|0.74|0.0382
74010975|NCT01131676|147573079|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.89|||<|0.0001|TWO_SIDED|95.02|0.78|1.01||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||1.01|0.78|<0.0001
74010976|NCT01131676|147573079|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0795|TWO_SIDED|95.02|0.78|1.01||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||1.01|0.78|0.0795
74010977|NCT01131676|147573080|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.4172|TWO_SIDED|95.0|0.7|2.33||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||2.33|0.70|0.4172
74041647|NCT03518034|147635524|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|1.04|1.97|||||Cox proportional-hazards model.|The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a subject is defined as the time from randomization to the first occurrence of a clinical fracture. If a subject does not experience a clinic fracture during the study, the follow-up time is right-censored at the time of subject's last available follow-up observation.||1.97|1.04|
74010978|NCT01131676|147573081|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0017|TWO_SIDED|95.0|0.5|0.85||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.85|0.50|0.0017
74010979|NCT01131676|147573082|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.2547|TWO_SIDED|95.0|0.87|1.04||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||1.04|0.87|0.2547
74010980|NCT01131676|147573083|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.72||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.72|0.54|<0.0001
74010981|NCT01131676|147573084|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.7||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.70|0.54|<0.0001
74093460|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.15|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.11|-0.15|
74093461|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.06|||||TWO_SIDED|95.0|-0.06|0.18|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.18|-0.06|
74010982|NCT01111851|147573090|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS Means|1.0|||||TWO_SIDED|90.0|0.99|1.01|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.01|0.99|
74010983|NCT01111851|147573091|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|1.0|||||TWO_SIDED|90.0|0.98|1.02|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.02|0.98|
74010984|NCT01111851|147573092|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|1.0|||||TWO_SIDED|90.0|0.97|1.03|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.03|0.97|
74093462|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.07|||||TWO_SIDED|95.0|-0.18|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.04|-0.18|
74093463|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.13|||||TWO_SIDED|95.0|-0.25|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||-0.01|-0.25|
73879528|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.87||0.0004|TWO_SIDED|95.0|-10.33|-2.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.96|-10.33|0.0004
74010985|NCT01111851|147573093|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|0.91|||||TWO_SIDED|90.0|0.5|1.66|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.66|0.50|
74010986|NCT01471015|147573098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
74010987|NCT01471015|147573099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
74010988|NCT02953340|147573100|NON_INFERIORITY|The study used non inferiority margin of 0.62 days for the above comparison. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean difference|-0.074|||<|0.0001|TWO_SIDED|95.0|-0.292|0.129|||t-statistics|The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.||||0.129|-0.292|< 0.0001
74010989|NCT01376778|147573110|SUPERIORITY||Risk Ratio (RR)|1.17||||0.42|TWO_SIDED|95.0|0.8|1.72|||Chi-squared|||||1.72|0.80|0.42
74010990|NCT01376778|147573115|SUPERIORITY||Risk Ratio (RR)|1.61|||||TWO_SIDED|95.0|0.86|3.03||||||||3.03|0.86|
74010991|NCT01376778|147573116|SUPERIORITY||Risk Ratio (RR)|2.82|||||TWO_SIDED|95.0|0.29|72.42||||||||72.42|0.29|
74010992|NCT01376778|147573117|SUPERIORITY||Risk Difference (RD)|-0.41|||||TWO_SIDED|||||||||||||
74010993|NCT01376778|147573118|SUPERIORITY||Risk Ratio (RR)|1.47|||||TWO_SIDED|95.0|0.81|2.67||||||||2.67|0.81|
74010994|NCT01376778|147573119|SUPERIORITY||Risk Ratio (RR)|1.61|||||TWO_SIDED|95.0|0.65|4.01||||||||4.01|0.65|
74010995|NCT01376778|147573121|SUPERIORITY||Risk Ratio (RR)|1.88|||||TWO_SIDED|95.0|0.66|5.41||||||||5.41|0.66|
74010996|NCT01376778|147573122|SUPERIORITY||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.66|0.15||||||||0.15|-0.66|
73887982|NCT01746901|147309528|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7259|TWO_SIDED|95.0|-1.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.7|0.7259
74010997|NCT01376778|147573123|SUPERIORITY||Risk Difference (RD)|-35.0|||||TWO_SIDED|95.0|-157.0|87.0||||||||87|-157|
74010998|NCT01376778|147573124|SUPERIORITY||Risk Ratio (RR)|1.92|||||TWO_SIDED|95.0|0.92|3.99||||||||3.99|0.92|
74010999|NCT01376778|147573128|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.03|31.5||||||||31.5|0.03|
74011000|NCT01376778|147573129|SUPERIORITY||Risk Ratio (RR)|0.48|||||TWO_SIDED|95.0|0.17|1.38||||||||1.38|0.17|
74011001|NCT01376778|147573132|SUPERIORITY||Risk Ratio (RR)|0.63|||||TWO_SIDED|95.0|0.32|1.23||||||||1.23|0.32|
74011002|NCT01376778|147573133|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.42|1.68||||||||1.68|0.42|
74011003|NCT01376778|147573134|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.17|5.23||||||||5.23|0.17|
74011004|NCT01376778|147573142|SUPERIORITY||Risk Ratio (RR)|1.3||||0.37|TWO_SIDED|95.0|0.7|2.5|||Chi-squared|||||2.5|0.7|0.37
74011005|NCT01376778|147573143|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
74011006|NCT01376778|147573144|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
74011007|NCT02700412|147573148|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
74011008|NCT02700412|147573149|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
74011009|NCT02684604|147573189|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74011010|NCT01197521|147573190|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.08|<0.001
74011011|NCT01197521|147573190|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.1||||0.006|TWO_SIDED|95.0|0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.03|0.006
74011012|NCT01197521|147573191|SUPERIORITY_OR_OTHER|||||||0.252||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.||||0.252
74011013|NCT01197521|147573191|SUPERIORITY_OR_OTHER|||||||0.17||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.||||0.170
74011014|NCT01197521|147573192|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.13|||<|0.001|TWO_SIDED|95.0|0.1|0.17||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.17|0.10|<0.001
74011015|NCT01197521|147573193|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.16|||<|0.001|TWO_SIDED|95.0|0.11|0.22||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.11|<0.001
74011016|NCT01197521|147573193|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.002|TWO_SIDED|95.0|0.03|0.14||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.14|0.03|0.002
74011017|NCT01197521|147573194|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.08|||<|0.001|TWO_SIDED|95.0|0.05|0.12||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|0.05|<0.001
74011018|NCT01197521|147573194|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.04||||0.015|TWO_SIDED|95.0|0.01|0.07||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|0.01|0.015
74041648|NCT03518034|147635525|OTHER|||||||0.002||||||p-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.|omnibus likelihood-ratio chi-square test|||Repeated measures log-binomial regression with effects for treatment, visit, treatment-by-visit interaction, and adjusted for pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.||||0.002
74041649|NCT03518034|147635526|SUPERIORITY|||||||0.494||||||P-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.|Repeated measures log-binomial regr.|||The risk ratio of progression to diabetes in the AndroGel versus placebo group was estimated by a repeated measures log-binomial regression with fixed effects for treatment, visit, treatment-visit interaction, and pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.||||0.494
74041650|NCT03518034|147635527|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.78|1.23|||||Cox proportional-hazards model adjusting for prior CVD.|||1.23|0.78|
74041651|NCT03518034|147635528|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.76|1.62|||||Cox proportional-hazards model adjusting for prior CVD.|||1.62|0.76|
74041652|NCT03518034|147635529|SUPERIORITY||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|0.92|2.32|||||Cox proportional-hazards model adjusting for prior CVD.|||2.32|0.92|
74093464|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.17|||||TWO_SIDED|95.0|0.05|0.28|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.28|0.05|
74041653|NCT03518034|147635530|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.56|1.51|||||Cox proportional-hazards model adjusting for prior CVD.|||1.51|0.56|
74041654|NCT03518034|147635531|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.55|2.31|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.31|0.55|
74041655|NCT03518034|147635532|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.47|2.42|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.42|0.47|
74041656|NCT03518034|147635533|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.65|2.41|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.41|0.65|
74093465|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.1|||||TWO_SIDED|95.0|0.0|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.21|-0.00|
74093466|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.17|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.05|-0.17|
74011019|NCT01197521|147573195|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
74011020|NCT01197521|147573195|SUPERIORITY_OR_OTHER|||||||0.002||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.002
74011021|NCT01197521|147573196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.0|||<|0.001|TWO_SIDED|95.0|2.44|14.64||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.64|2.44|<0.001
74011022|NCT01197521|147573196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4||||0.002|TWO_SIDED|95.0|1.76|11.02||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||11.02|1.76|0.002
74011023|NCT01197521|147573197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|1.63|5.67||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||5.67|1.63|<0.001
74011024|NCT01197521|147573197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.083|TWO_SIDED|95.0|0.93|3.5||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.50|0.93|0.083
74011025|NCT01197521|147573198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.79|3.3||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.30|1.79|<0.001
74011026|NCT01197521|147573198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.004|TWO_SIDED|95.0|1.16|2.14||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.14|1.16|0.004
74041657|NCT03518034|147635534|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.87|1.54|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||1.54|0.87|
74041658|NCT03518034|147635535|SUPERIORITY||Hazard Ratio (HR)|1.91|||||TWO_SIDED|95.0|0.95|3.84|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||3.84|0.95|
74041659|NCT00010803|147635538|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.12||||0.21|TWO_SIDED|95.0|0.94|1.33|||Log Rank|Time to dementia in Ginkgo vs placebo groups. The Cox proportional hazards model was used to compute hazard ratios and log-rank tests.||The null hypothesis is that the instantaneous hazard rate for Ginkgo biloba and placebo are the same. Assumptions were based on 4%/yr dementia and 6%/yr mortality and dropout combined. A sample size of 3000 with an average follow up of 5 years resulted in 96% power to detecting a 30% reduction in the rate of dementia at a 2-sided significance level of 0.5.||1.33|0.94|0.21
74041660|NCT00010803|147635539|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.04||||0.7|TWO_SIDED|95.0|0.85|1.27|||Log Rank|||Total Mortality||1.27|0.85|0.70
73879529|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0014|TWO_SIDED|95.0|-9.64|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.34|-9.64|0.0014
74011027|NCT01197521|147573199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.68|3.26||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.26|1.68|<0.001
74011028|NCT01197521|147573199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.38|2.68||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.68|1.38|<0.001
74011029|NCT01197521|147573200|SUPERIORITY_OR_OTHER||Treatment difference|2.24|||<|0.001||95.0|1.16|3.31||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.31|1.16|<0.001
74011030|NCT01197521|147573200|SUPERIORITY_OR_OTHER||Treatment difference|1.27||||0.02||95.0|0.2|2.35||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.35|0.20|0.020
74011031|NCT01197521|147573201|SUPERIORITY_OR_OTHER||Treatment difference|1.8||||0.005||95.0|0.54|3.07||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.07|0.54|0.005
74011032|NCT01197521|147573201|SUPERIORITY_OR_OTHER||Treatment difference|1.56||||0.017||95.0|0.28|2.83||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.83|0.28|0.017
74011033|NCT02285777|147573214|OTHER|Pre-specified.|Vaccine Effectiveness|71.0||||0.0001|TWO_SIDED|95.0|69.0|73.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains was computed by mean of a generalized linear model.||73|69|0.0001
74011034|NCT02285777|147573215|OTHER|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|TWO_SIDED|95.0|48.0|55.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||55|48|0.0001
74011035|NCT02285777|147573216|OTHER|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|TWO_SIDED|95.0|48.0|54.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||54|48|0.0001
74041661|NCT00010803|147635539|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.06||||0.78|TWO_SIDED|95.0|0.7|1.62|||Log Rank|||Atherosclerotic CHD mortality||1.62|0.70|0.78
74041662|NCT00010803|147635539|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.12||||0.54|TWO_SIDED|95.0|0.79|1.58|||Log Rank|||Incident Myocardial Infarction||1.58|0.79|0.54
74041663|NCT00010803|147635539|NON_INFERIORITY_OR_EQUIVALENCE|Previously Provided|Hazard Ratio (HR)|0.84||||0.32|TWO_SIDED|95.0|0.61|1.18|||Log Rank|||Incident Angina||1.18|0.61|0.32
74041664|NCT00010803|147635539|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.94||||0.66|TWO_SIDED|95.0|0.72|1.23|||Log Rank|||Incident CHD||1.23|0.72|0.66
73887983|NCT01746901|147309528|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.7813|TWO_SIDED|95.0|-1.6|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.6|0.7813
74041665|NCT00010803|147635539|NON_INFERIORITY_OR_EQUIVALENCE|Previously Provided|Hazard Ratio (HR)|0.91||||0.48|TWO_SIDED|95.0|0.71|1.18|||Log Rank|||Incident CHF||1.18|0.71|0.48
74041666|NCT00010803|147635539|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.87||||0.25|TWO_SIDED|95.0|0.52|1.45|||Log Rank|||Incident Stroke||1.45|0.52|0.25
74041667|NCT00010803|147635539|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.87||||0.59|TWO_SIDED|95.0|0.52|1.45|||Log Rank|||Incident TIA||1.45|0.52|0.59
74093467|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.08|||||TWO_SIDED|95.0|-0.04|0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.19|-0.04|
74093468|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.1|||||TWO_SIDED|95.0|-0.02|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.21|-0.02|
74011036|NCT02285777|147573216|OTHER|Pre-specified.|Vaccine Effectiveness|24.0||||0.0001||95.0|20.0|28.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||28|20|0.0001
74011037|NCT01431274|147573246|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.1|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.146|0.100|<0.0001
74011038|NCT01431274|147573246|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.117|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.094|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.140|0.094|<0.0001
74011039|NCT01431274|147573246|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.109|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.086|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.132|0.086|<0.0001
74011040|NCT01431274|147573246|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.093|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.07|0.116||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.116|0.070|<0.0001
74011041|NCT01431274|147573246|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.102|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.08|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.125|0.080|<0.0001
74041668|NCT00010803|147635539|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Cox Proportional Hazard|1.12||||0.42|TWO_SIDED|95.0|0.84|1.5|||Log Rank|||Incident CVD||1.50|0.84|0.42
74041669|NCT00010803|147635539|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.8|1.25|||Log Rank|||Total CHD and CVD combined||1.25|0.80|0.98
74041670|NCT00010803|147635540|SUPERIORITY_OR_OTHER||Treatment X Time interaction|-0.002||||0.65|TWO_SIDED|95.0|-0.009|0.005|||Mixed Models Analysis|||Linear mixed models comparing rates of change in global cognition scores (z-scores) by treatment group||0.005|-0.009|.65
74041671|NCT01019252|147635541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.24|||<|0.0001|TWO_SIDED|95.0|3.28|7.21|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||7.21|3.28|<.0001
74041672|NCT01019252|147635542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.94|1.39|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||1.39|.94|<.0001
74041673|NCT01019252|147635543|SUPERIORITY||Mean Difference (Net)|10.93|||<|0.0001|TWO_SIDED|95.0|8.93|12.93|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||12.93|8.93|<.0001
74041674|NCT03351478|147635551|SUPERIORITY||Difference in Least Square (LS) Means|-0.43|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.62|-0.25|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline HbA1c as a covariate.||-0.25|-0.62|< 0.0001
74093469|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.1|0.14|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.14|-0.10|
74093470|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.03|||||TWO_SIDED|95.0|-0.1|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.15|-0.10|
73879530|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.1|STANDARD_ERROR_OF_MEAN|1.82||0.0054|TWO_SIDED|95.0|-8.67|-1.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.51|-8.67|0.0054
73879531|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.82||0.0008|TWO_SIDED|95.0|-9.71|-2.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.55|-9.71|0.0008
73879532|NCT03192176|147297613|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.84|<|0.0001|TWO_SIDED|95.0|-11.2|-3.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.97|-11.20|<0.0001
73879533|NCT03192176|147297613|SUPERIORITY||LSMean difference|-8.2|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-11.88|-4.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-4.59|-11.88|<0.0001
73879534|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.85||0.0026|TWO_SIDED|95.0|-9.27|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.99|-9.27|0.0026
73879535|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.83||0.0003|TWO_SIDED|95.0|-10.35|-3.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.16|-10.35|0.0003
74011042|NCT01431274|147573246|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2169|TWO_SIDED|95.0|-0.008|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.037|-0.008|0.2169
74011043|NCT01431274|147573246|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.085|0.13||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.130|0.085|<0.0001
74041675|NCT03351478|147635551|SUPERIORITY||Difference in LS Means|0.12|STANDARD_ERROR_OF_MEAN|0.08||0.145|TWO_SIDED|95.0|-0.04|0.28|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline HbA1c as a covariate.||0.28|-0.04|0.145
74093471|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.17|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.07|-0.17|
74093472|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.08|||||TWO_SIDED|95.0|-0.2|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.05|-0.20|
74041676|NCT03351478|147635552|SUPERIORITY||Difference in LS Means|-2.05|STANDARD_ERROR_OF_MEAN|1.43||0.1529|TWO_SIDED|95.0|-4.87|0.76|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||0.76|-4.87|0.1529
74093473|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.01|||||TWO_SIDED|95.0|-0.11|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.13|-0.11|
73879536|NCT03192176|147297613|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.81||0.0006|TWO_SIDED|95.0|-9.88|-2.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.75|-9.88|0.0006
73879537|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|2.12||0.0126|TWO_SIDED|95.0|-9.48|-1.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.15|-9.48|0.0126
73879538|NCT03192176|147297613|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|2.12||0.1724|TWO_SIDED|95.0|-7.06|1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||1.27|-7.06|0.1724
74093474|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.14|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.10|-0.14|
74011044|NCT01431274|147573246|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.012||0.5849|TWO_SIDED|95.0|-0.017|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.029|-0.017|0.5849
74011045|NCT01431274|147573246|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.012||0.1863|TWO_SIDED|95.0|-0.007|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.007|0.1863
74011046|NCT01431274|147573246|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4352|TWO_SIDED|95.0|-0.032|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.014|-0.032|0.4352
74011047|NCT01431274|147573247|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.082|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.059|0.106||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.106|0.059|<.0001
74041677|NCT03351478|147635552|SUPERIORITY||Difference in LS Means|1.17|STANDARD_ERROR_OF_MEAN|1.21||0.3377|TWO_SIDED|95.0|-1.21|3.55|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||3.55|-1.21|0.3377
74041678|NCT03351478|147635553|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.33|-0.5|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline 2-hour postprandial glucose as a covariate.||-0.5|-1.33|<0.0001
74041679|NCT03351478|147635553|SUPERIORITY||Difference in LS Means|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.8397|TWO_SIDED|95.0|-0.37|0.3|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥ 130 mmHg) at screening, and the country as fixed effects, and baseline 2-hour postprandial glucose as a covariate.||0.3|-0.37|0.8397
74041680|NCT03351478|147635554|SUPERIORITY||Difference in LS Means|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0005|TWO_SIDED|95.0|-1.25|-0.35|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.35|-1.25|0.0005
74041681|NCT03351478|147635554|SUPERIORITY||Difference in LS Means|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1339|TWO_SIDED|95.0|-0.09|0.7|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline fasting plasma glucose as a covariate.||0.7|-0.09|0.1339
74093475|NCT00444457|147738354|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.15|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.08|-0.15|
74041682|NCT03351478|147635555|SUPERIORITY||Difference in LS Means|-2.25|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.95|-1.54|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline weight as a covariate.||-1.54|-2.95|<0.0001
74041683|NCT03351478|147635555|SUPERIORITY||Difference in LS Means|0.51|STANDARD_ERROR_OF_MEAN|0.34||0.1407|TWO_SIDED|95.0|-0.17|1.19|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline weight as a covariate.||1.19|-0.17|0.1407
74041684|NCT03351478|147635556|SUPERIORITY||Difference in LS Means|-2.03|STANDARD_ERROR_OF_MEAN|0.95||0.0325|TWO_SIDED|95.0|-3.89|-0.17|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||-0.17|-3.89|0.0325
74093476|NCT01121666|147738365|NON_INFERIORITY_OR_EQUIVALENCE|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003|TWO_SIDED|||||This study was powered to test equivalence using a two one-sided test (TOST) with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.|Shuirmann's TOST|||This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved.||||0.0003
74093477|NCT01121666|147738366|SUPERIORITY_OR_OTHER|||||||0.2357|TWO_SIDED|||||Follicles of 12 mm|Wilcoxon (Mann-Whitney)|||||||0.2357
74093478|NCT01121666|147738366|SUPERIORITY_OR_OTHER|||||||0.1395|TWO_SIDED|||||Follicles of 15 mm|Wilcoxon (Mann-Whitney)|||||||0.1395
74093479|NCT01121666|147738366|SUPERIORITY_OR_OTHER|||||||0.3992|TWO_SIDED|||||Follicles of 17 mm|Wilcoxon (Mann-Whitney)|||||||0.3992
74093480|NCT01121666|147738368|SUPERIORITY_OR_OTHER|||||||0.9638|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9638
74093481|NCT01121666|147738373|SUPERIORITY_OR_OTHER|||||||0.8926|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8926
74093482|NCT01121666|147738380|NON_INFERIORITY_OR_EQUIVALENCE|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003|TWO_SIDED||||||Shuirmann's TOST|||||||0.0003
74093483|NCT03176459|147738389|SUPERIORITY||LSM treatment difference|-16.5||||0.0117|TWO_SIDED|95.0|-30.8|-2.2|||ANCOVA|||||-2.2|-30.8|0.0117
74093484|NCT03176459|147738390|NON_INFERIORITY|Pre-specified non-inferiority margin of 36|LSM treatment difference (SE)|-30.6||||0.002|TWO_SIDED|95.0|-75.9|14.7|||ANCOVA|||||14.7|-75.9|0.0020
74093485|NCT03176459|147738391|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0012|TWO_SIDED|95.0|1.557|7.906|||LSM probability from logistic regression|||||7.906|1.557|0.0012
74093486|NCT03176459|147738392|SUPERIORITY||Least squares treatment difference|-3.2||||0.0543|TWO_SIDED||||||ANCOVA|||||||.0543
74093487|NCT03176459|147738393|SUPERIORITY||Least squares treatment difference|-11.4||||0.0096|ONE_SIDED||||||ANCOVA|||||||.0096
74011048|NCT01431274|147573247|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.047|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.094|0.047|<0.0001
74093488|NCT03176459|147738394|SUPERIORITY||Least squares treatment difference|-22.4||||0.0175|TWO_SIDED||||||ANCOVA|||||||.0175
74093489|NCT03176459|147738395|SUPERIORITY||Least squares treatment difference|-19.6||||0.0542|TWO_SIDED||||||ANCOVA|||||||.0542
74093490|NCT03176459|147738396|SUPERIORITY|||||||0.7536|||||||Regression, Cox|||||||0.7536
74093491|NCT03176459|147738397|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3609|TWO_SIDED||||||Regression, Logistic|||||||0.3609
74093492|NCT01383421|147738451|SUPERIORITY||||||<|0.001||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||< 0.001
74093493|NCT01383421|147738453|SUPERIORITY|||||||0.058||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||0.058
74093494|NCT01383421|147738455|SUPERIORITY|||||||0.003||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||0.003
74093495|NCT01383421|147738457|SUPERIORITY||LS Mean Difference|-0.203|STANDARD_ERROR_OF_MEAN|0.092||0.027|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.027
74093496|NCT01383421|147738457|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.094||0.006|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.006
74093497|NCT01383421|147738457|SUPERIORITY||LS Mean Difference|-0.233|STANDARD_ERROR_OF_MEAN|0.098||0.018|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.018
74093498|NCT01383421|147738458|SUPERIORITY||LS Mean Difference|-1.686|STANDARD_ERROR_OF_MEAN|0.893||0.059|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.059
74093499|NCT01383421|147738458|SUPERIORITY||LS Mean Difference|-2.697|STANDARD_ERROR_OF_MEAN|0.903||0.003|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.003
74093500|NCT01383421|147738458|SUPERIORITY||LS Mean Difference|-2.447|STANDARD_ERROR_OF_MEAN|0.945||0.01|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.010
74093501|NCT01383421|147738459|SUPERIORITY||LS Mean Difference|-1.791|STANDARD_ERROR_OF_MEAN|0.788||0.023|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.023
74093502|NCT01383421|147738459|SUPERIORITY||LS Mean Difference|-2.549|STANDARD_ERROR_OF_MEAN|0.818||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.002
74093503|NCT01383421|147738459|SUPERIORITY||LS Mean Difference|-2.734|STANDARD_ERROR_OF_MEAN|0.872||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.002
74093504|NCT01383421|147738463|SUPERIORITY||LS Mean Difference|1.333|STANDARD_ERROR_OF_MEAN|2.725||0.625|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.625
74093505|NCT01383421|147738463|SUPERIORITY||LS Mean Difference|-0.824|STANDARD_ERROR_OF_MEAN|2.441||0.736|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.736
74093506|NCT01383421|147738463|SUPERIORITY||LS Mean Difference|1.207|STANDARD_ERROR_OF_MEAN|3.126||0.7|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.700
74093507|NCT01383421|147738463|SUPERIORITY||LS Mean Difference|-3.552|STANDARD_ERROR_OF_MEAN|1.561||0.023|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||0.023
74093508|NCT01383421|147738464|SUPERIORITY||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|2.736||0.89|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.890
74093509|NCT01383421|147738464|SUPERIORITY||LS Mean Difference|-0.527|STANDARD_ERROR_OF_MEAN|2.523||0.835|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.835
74093510|NCT01383421|147738464|SUPERIORITY||LS Mean Difference|-0.471|STANDARD_ERROR_OF_MEAN|3.205||0.883|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.883
74093511|NCT01383421|147738464|SUPERIORITY||LS Mean Difference|-3.792|STANDARD_ERROR_OF_MEAN|1.611||0.019|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||0.019
74093512|NCT01383421|147738465|SUPERIORITY||LS Mean Difference|-0.409|STANDARD_ERROR_OF_MEAN|2.548||0.873|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.873
74093513|NCT01383421|147738465|SUPERIORITY||LS Mean Difference|-0.817|STANDARD_ERROR_OF_MEAN|2.598||0.753|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.753
74093514|NCT01383421|147738465|SUPERIORITY||LS Mean Difference|-2.334|STANDARD_ERROR_OF_MEAN|3.159||0.461|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.461
74011049|NCT01431274|147573247|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.081|0.034|<0.0001
74011050|NCT01431274|147573247|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0174|TWO_SIDED|95.0|0.005|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.052|0.005|0.0174
74011051|NCT01431274|147573247|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.012||0.0001|TWO_SIDED|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.070|0.023|0.0001
74093515|NCT01383421|147738465|SUPERIORITY||LS Mean Difference|-5.537|STANDARD_ERROR_OF_MEAN|1.624|<|0.001|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||<0.001
74093516|NCT01383421|147738466|SUPERIORITY||LS Mean Difference|2.973|STANDARD_ERROR_OF_MEAN|1.245||0.017|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.017
74093517|NCT01383421|147738466|SUPERIORITY||LS Mean Difference|2.843|STANDARD_ERROR_OF_MEAN|2.042||0.164|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.164
74093518|NCT01383421|147738466|SUPERIORITY||LS Mean Difference|5.473|STANDARD_ERROR_OF_MEAN|1.866||0.003|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||0.003
74093519|NCT01383421|147738466|SUPERIORITY||LS Mean Difference|1.705|STANDARD_ERROR_OF_MEAN|1.769||0.335|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.335
74093520|NCT01383421|147738467|SUPERIORITY||LS Mean Difference|2.728|STANDARD_ERROR_OF_MEAN|1.183||0.021|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.021
74093521|NCT01383421|147738467|SUPERIORITY||LS Mean Difference|3.124|STANDARD_ERROR_OF_MEAN|1.93||0.106|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.106
74093522|NCT01383421|147738467|SUPERIORITY||LS Mean Difference|5.572|STANDARD_ERROR_OF_MEAN|1.756||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||0.002
74093523|NCT01383421|147738467|SUPERIORITY||LS Mean Difference|1.885|STANDARD_ERROR_OF_MEAN|1.704||0.269|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.269
74011052|NCT01431274|147573247|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0407|TWO_SIDED|95.0|0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.048|0.001|0.0407
74011053|NCT01431274|147573247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.03|0.077||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.077|0.030|<0.0001
74041685|NCT03351478|147635556|SUPERIORITY||Difference in LS Means|1.1|STANDARD_ERROR_OF_MEAN|0.78||0.1565|TWO_SIDED|95.0|-0.42|2.63|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||2.63|-0.42|0.1565
74041686|NCT03351478|147635557|SUPERIORITY||percentage difference|8.1||||0.0048|TWO_SIDED|95.0|3.36|12.89|||Cochran-Mantel-Haenszel|||The percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at the screening.||12.89|3.36|0.0048
74041687|NCT03351478|147635558|SUPERIORITY||Percentage Difference|16.9||||0.0001|TWO_SIDED|95.0|9.26|24.52|||Cochran-Mantel-Haenszel|||The percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at the screening.||24.52|9.26|0.0001
74041688|NCT00763243|147635618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|2.17||0.766|TWO_SIDED|95.0|-1.44|1.89|||t-test, 2 sided|t(8)=0.31||Change during waiting period (no intervention); no change was hypothesized||1.89|-1.44|0.766
74041689|NCT00763243|147635618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_DEVIATION|1.0|<|0.001|TWO_SIDED|95.0|0.9|2.44|||t-test, 2 sided|t(8)=5.0||Change during the training period||2.44|0.90|<0.001
74041690|NCT00763243|147635618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78|STANDARD_DEVIATION|1.86||0.021|TWO_SIDED|95.0|0.35|3.2|||t-test, 2 sided|t(8)=2.87||Change from pre-training through follow-up period||3.20|0.35|0.021
74041691|NCT00763243|147635618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_DEVIATION|1.12||0.4|TWO_SIDED|95.0|-0.53|1.19|||t-test, 2 sided|t(8)=0.89||Change from pretraining to 6 month follow up||1.19|-0.53|0.40
74041692|NCT00763243|147635619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|2.24||0.11|TWO_SIDED|95.0|-0.39|3.05|||t-test, 2 sided|t(8)=1.79||Change during waiting period of no intervention||3.05|-0.39|0.11
74041693|NCT00763243|147635619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|STANDARD_DEVIATION|1.81||0.004|TWO_SIDED|95.0|1.05|3.84|||t-test, 2 sided|t(8)=4.05||Change during training period||3.84|1.05|0.004
74041694|NCT00763243|147635619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11|STANDARD_DEVIATION|3.06||0.072|TWO_SIDED|95.0|-0.24|4.46|||t-test, 2 sided|t(8)=2.07||1 Month Follow Up change from pre-training||4.46|-0.24|0.072
74041695|NCT00763243|147635619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|2.28||0.34|TWO_SIDED|95.0|-0.97|2.53|||t-test, 2 sided|t(8)=1.02||6 month follow up change from pre-training||2.53|-0.97|0.34
74041696|NCT00763243|147635620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|1.86||0.729|TWO_SIDED|95.0|-1.2|1.65|||t-test, 2 sided|t(8)=0.36||Waiting period - no treatment||1.65|-1.20|0.729
74041697|NCT00763243|147635620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_DEVIATION|2.17||0.039|TWO_SIDED|95.0|-3.44|-0.11|||t-test, 2 sided|t(8)=2.46||Training Period - Pretraining to Post-Training Visit||-0.11|-3.44|0.039
74041698|NCT00763243|147635620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_DEVIATION|2.98||0.4|TWO_SIDED|95.0|-3.17|1.4|||t-test, 2 sided|t(8)=0.90||1 Month Follow Up Period from Pretraining||1.40|-3.17|0.40
74041699|NCT00763243|147635620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_DEVIATION|2.5||0.4|TWO_SIDED|95.0|-2.59|1.26|||t-test, 2 sided|t(8)=0.89||6 Month Follow Up period from pretraining||1.26|-2.59|0.40
74041700|NCT00425100|147635631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.1|<|0.0001||95.0|-3.2|-2.7||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of micturition episodes per 24 hours at Week 12 is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-2.7|-3.2|<0.0001
74041701|NCT00425100|147635632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|2.4|<|0.0001||95.0|-2.0|-1.4||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency urinary incontinence per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-1.4|-2.0|<0.0001
73879539|NCT03192176|147297613|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.18||0.3548|TWO_SIDED|95.0|-6.31|2.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||2.27|-6.31|0.3548
73879540|NCT03192176|147297613|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|2.18||0.086|TWO_SIDED|95.0|-8.04|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.53|-8.04|0.0860
74011054|NCT01431274|147573247|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3326|TWO_SIDED|95.0|-0.012|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.035|-0.012|0.3326
74011055|NCT01431274|147573247|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0151|TWO_SIDED|95.0|0.006|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.053|0.006|0.0151
74011056|NCT01431274|147573247|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.012||0.1421|TWO_SIDED|95.0|-0.041|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.006|-0.041|0.1421
74011057|NCT01431274|147573248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.693|STANDARD_ERROR_OF_MEAN|0.553||0.0022|TWO_SIDED|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.608|-2.778|0.0022
74011058|NCT01431274|147573248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.233|STANDARD_ERROR_OF_MEAN|0.551||0.0252|TWO_SIDED|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.153|-2.313|0.0252
74011059|NCT01431274|147573248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.031|STANDARD_ERROR_OF_MEAN|0.552||0.062|TWO_SIDED|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.052|-2.113|0.0620
74041702|NCT00425100|147635633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|STANDARD_DEVIATION|4.8|<|0.0001||95.0|-5.4|-4.5||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency episodes per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-4.5|-5.4|<0.0001
74041703|NCT00425100|147635635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2 sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74093524|NCT01383421|147738468|SUPERIORITY||LS Mean Difference|2.324|STANDARD_ERROR_OF_MEAN|1.177||0.049|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.049
74011060|NCT01431274|147573248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.456|STANDARD_ERROR_OF_MEAN|0.548||0.4051|TWO_SIDED|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.618|-1.531|0.4051
74011061|NCT01431274|147573248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.571|STANDARD_ERROR_OF_MEAN|0.55||0.2988|TWO_SIDED|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.507|-1.649|0.2988
73887984|NCT01746901|147309528|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.5235|TWO_SIDED|95.0|-1.9|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.0|-1.9|0.5235
74011062|NCT01431274|147573248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.662|STANDARD_ERROR_OF_MEAN|0.545||0.2249|TWO_SIDED|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.407|-1.731|0.2249
74011063|NCT01431274|147573248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.118|STANDARD_ERROR_OF_MEAN|0.549||0.0418|TWO_SIDED|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||-0.042|-2.195|0.0418
74011064|NCT01431274|147573248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.557||0.4097|TWO_SIDED|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within-patient errors."|||0.633|-1.552|0.4097
74011065|NCT01431274|147573248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.575|STANDARD_ERROR_OF_MEAN|0.556||0.3013|TWO_SIDED|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.515|-1.664|0.3013
74011066|NCT01431274|147573248|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.554||0.8355|TWO_SIDED|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||1.200|-0.970|0.8355
74011067|NCT01431274|147573249|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.135||0.0019|TWO_SIDED|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.684|0.155|0.0019
74011068|NCT01431274|147573249|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.356|STANDARD_ERROR_OF_MEAN|0.135||0.0082|TWO_SIDED|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.619|0.092|0.0082
74011069|NCT01431274|147573249|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.416|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.681|0.152|0.0020
74011070|NCT01431274|147573249|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.134||0.0307|TWO_SIDED|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.554|0.027|0.0307
74011071|NCT01431274|147573249|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.352|STANDARD_ERROR_OF_MEAN|0.135||0.0088|TWO_SIDED|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.616|0.089|0.0088
74011072|NCT01431274|147573249|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.134||0.9801|TWO_SIDED|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.266|-0.259|0.9801
74011073|NCT01431274|147573249|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.294|STANDARD_ERROR_OF_MEAN|0.134||0.0289|TWO_SIDED|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.557|0.030|0.0289
74011074|NCT01431274|147573249|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.136||0.6382|TWO_SIDED|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.330|-0.202|0.6382
73879541|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.19||0.0111|TWO_SIDED|95.0|-9.89|-1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.28|-9.89|0.0111
74011075|NCT01431274|147573249|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.135||0.3525|TWO_SIDED|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.391|-0.140|0.3525
74011076|NCT01431274|147573249|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.062|STANDARD_ERROR_OF_MEAN|0.135||0.6457|TWO_SIDED|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.203|-0.327|0.6457
74011077|NCT01431274|147573250|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.012||0.0067|TWO_SIDED|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.056|0.009|0.0067
74011078|NCT01431274|147573250|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.081|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.104|0.057|<0.0001
74011079|NCT01431274|147573250|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.012||0.0746|TWO_SIDED|95.0|-0.002|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.045|-0.002|0.0746
74011080|NCT01431274|147573250|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.078|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.054|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.101|0.054|<0.0001
74011081|NCT01431274|147573250|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.093|0.046|<0.0001
74011082|NCT01431274|147573250|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.012||0.3549|TWO_SIDED|95.0|-0.013|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.035|-0.013|0.3549
74011083|NCT01431274|147573250|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.089|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.065|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.113|0.065|<0.0001
74011084|NCT01431274|147573250|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.048|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.072|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.025|-0.072|<0.0001
74041704|NCT00425100|147635636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_DEVIATION|4.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74041705|NCT00425100|147635637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74093525|NCT01383421|147738468|SUPERIORITY||LS Mean Difference|4.929|STANDARD_ERROR_OF_MEAN|1.929||0.011|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.011
74011085|NCT01431274|147573250|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.08|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.033|-0.080|<0.0001
74011086|NCT01431274|147573250|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.012||0.5018|TWO_SIDED|95.0|-0.016|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.032|-0.016|0.5018
74011087|NCT01431274|147573251|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.104|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.152|0.104|<0.0001
74011088|NCT01431274|147573251|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.102|0.15||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.150|0.102|<0.0001
73879542|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.19||0.0349|TWO_SIDED|95.0|-8.94|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.33|-8.94|0.0349
74011089|NCT01431274|147573251|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.087|0.135||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.135|0.087|<0.0001
74011090|NCT01431274|147573251|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.096|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.072|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.120|0.072|<0.0001
74011091|NCT01431274|147573251|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.109|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.085|0.133||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.133|0.085|<0.0001
74011092|NCT01431274|147573251|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.012||0.1569|TWO_SIDED|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.041|-0.007|0.1569
74041706|NCT00425100|147635638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|1.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74041707|NCT00425100|147635640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74041708|NCT00425100|147635642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.6|STANDARD_DEVIATION|26.4|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74041709|NCT00425100|147635643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|30.6|STANDARD_DEVIATION|26.6|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74011093|NCT01431274|147573251|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.113|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.089|0.137||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.137|0.089|<0.0001
74041710|NCT00425100|147635644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.9|STANDARD_DEVIATION|27.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74011094|NCT01431274|147573251|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.002|STANDARD_ERROR_OF_MEAN|0.012||0.8834|TWO_SIDED|95.0|-0.022|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.026|-0.022|0.8834
74011095|NCT01431274|147573251|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.012||0.2129|TWO_SIDED|95.0|-0.009|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.009|0.2129
74011096|NCT01431274|147573251|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.013|STANDARD_ERROR_OF_MEAN|0.012||0.2702|TWO_SIDED|95.0|-0.037|0.01||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.010|-0.037|0.2702
74011097|NCT01431274|147573252|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.117|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.166|0.117|<0.0001
74011098|NCT01431274|147573252|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.09|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.139|0.090|<0.0001
74011099|NCT01431274|147573252|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.119|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.094|0.143||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.143|0.094|<0.0001
74011100|NCT01431274|147573252|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.099|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.074|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.123|0.074|<0.0001
74011101|NCT01431274|147573252|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.092|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.067|0.117||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.117|0.067|<0.0001
74011102|NCT01431274|147573252|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.023|STANDARD_ERROR_OF_MEAN|0.013||0.0717|TWO_SIDED|95.0|-0.002|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.002|0.0717
74041711|NCT00425100|147635645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.8|STANDARD_DEVIATION|21.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74041712|NCT00425100|147635646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.1|STANDARD_DEVIATION|22.8|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74093526|NCT01383421|147738468|SUPERIORITY||LS Mean Difference|5.997|STANDARD_ERROR_OF_MEAN|1.775|<|0.001|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||<0.001
74093527|NCT01383421|147738468|SUPERIORITY||LS Mean Difference|1.823|STANDARD_ERROR_OF_MEAN|1.657||0.272|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.272
74041713|NCT00425100|147635647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.7|STANDARD_DEVIATION|22.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74093528|NCT01383421|147738469|SUPERIORITY||LS Mean Difference|0.817|STANDARD_ERROR_OF_MEAN|0.572||0.154|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.154
74093529|NCT01383421|147738469|SUPERIORITY||LS Mean Difference|0.772|STANDARD_ERROR_OF_MEAN|0.599||0.198|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.198
73879543|NCT03192176|147297613|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.12||0.2205|TWO_SIDED|95.0|-6.77|1.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.57|-6.77|0.2205
73879544|NCT03192176|147297613|SUPERIORITY||LSMean differencce|-4.0|STANDARD_ERROR_OF_MEAN|2.17||0.0645|TWO_SIDED|95.0|-8.29|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.24|-8.29|0.0645
74011103|NCT01431274|147573252|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.097|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.146|0.097|<0.0001
74011104|NCT01431274|147573252|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0344|TWO_SIDED|95.0|0.002|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.051|0.002|0.0344
74011105|NCT01431274|147573252|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.1126|TWO_SIDED|95.0|-0.005|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.045|-0.005|0.1126
74011106|NCT01431274|147573252|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.6009|TWO_SIDED|95.0|-0.018|0.031||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.031|-0.018|0.6009
74011107|NCT01431274|147573253|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.072|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.049|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.096|0.049|<0.0001
74093530|NCT01383421|147738469|SUPERIORITY||LS Mean Difference|0.884|STANDARD_ERROR_OF_MEAN|0.585||0.131|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.131
74093531|NCT01383421|147738473|SUPERIORITY||LS Mean Between Group Change|0.1|STANDARD_ERROR_OF_MEAN|0.0429||0.019|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Necessity||||0.019
74093532|NCT01383421|147738473|SUPERIORITY||LS Mean Between Group Change|0.0|STANDARD_ERROR_OF_MEAN|0.0526||0.56|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Concern||||0.560
74093533|NCT01461226|147738525|OTHER|Mixed models analysis|mixed models|0.04|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
74093534|NCT01461226|147738525|OTHER||mixed models|0.24||||0.64|TWO_SIDED|||||Baseline difference between groups|Mixed Models Analysis|||||||0.64
74093535|NCT01461226|147738525|OTHER|Mixed models|Slope|0.27||||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
74093536|NCT01461226|147738525|OTHER|mixed models|mixed models|4.2||||0.04|TWO_SIDED||||||Mixed Models Analysis|||change after 10 months between groups||||0.04
74093537|NCT00062010|147738528|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percentage|8.8|||||TWO_SIDED|90.0|2.4|21.3||||||The study was designed to have adequate (90%) power to distinguish a true response rate of 50% from a null rate of 35% assuming total accrual of 76 patients in two stages. The design mandated that at least 13 objective responses be observed among 34 patients in the first stage in order to continue to the second stage. These were not observed, so the study stopped after the first stage. 90% exact binomial confidence intervals are provided for the response rate.||21.3|2.4|
74093538|NCT02856880|147738531|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|40.18|||<|0.0001|TWO_SIDED|95.0|32.37|47.99||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque Glycolysis for the first named treatment.|||47.99|32.37|<0.0001
74093539|NCT02856880|147738532|SUPERIORITY_OR_OTHER||LS mean difference|26.41|||<|0.0001|TWO_SIDED|95.0|18.94|33.88||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||33.88|18.94|<0.0001
74093540|NCT02856880|147738532|SUPERIORITY_OR_OTHER||LS mean difference|-2.91||||0.4823|TWO_SIDED|95.0|-11.18|5.37||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of glycolysis for the first named treatment.|||5.37|-11.18|0.4823
73879545|NCT03192176|147297613|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|2.16||0.5031|TWO_SIDED|95.0|-5.69|2.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.80|-5.69|0.5031
74011108|NCT01431274|147573253|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.039|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.087|0.039|<0.0001
74041714|NCT00425100|147635649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.2|STANDARD_DEVIATION|14.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
74041715|NCT02781454|147635669|SUPERIORITY||linear contrast active vs placebo|-5.558||||0.039|TWO_SIDED|95.0|-10.8|-0.315|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||-0.315|-10.80|0.039
74041716|NCT02781454|147635670|SUPERIORITY||linear contrast active vs placebo|0.792||||0.332|TWO_SIDED|95.0|0.484|1.296||linear contrast active vs placebo|Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||1.296|0.484|0.332
74041717|NCT02781454|147635671|SUPERIORITY||linear contrast active vs placebo|0.411||||0.013|TWO_SIDED|95.0|0.208|0.81|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||0.810|0.208|0.013
74041718|NCT02781454|147635672|SUPERIORITY||linear contrast active vs placebo|0.343||||0.986|TWO_SIDED|95.0|-41.36|42.042|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||42.042|-41.36|0.986
74041719|NCT02781454|147635673|SUPERIORITY||linear contrast active vs placebo|0.994||||0.915|TWO_SIDED|95.0|0.876|1.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||1.126|0.876|0.915
74041720|NCT02781454|147635674|SUPERIORITY||linear contrast active vs placebo|1.089||||0.694|TWO_SIDED|95.0|-4.609|6.786|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||6.786|-4.609|0.694
74041721|NCT02781454|147635675|SUPERIORITY||linear contrast active vs placebo|0.242||||0.969|TWO_SIDED|95.0|-12.64|13.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||13.126|-12.64|0.969
74041722|NCT02781454|147635676|SUPERIORITY||linear contrast active vs placebo|2.597||||0.323|TWO_SIDED|95.0|-2.772|7.966|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||7.966|-2.772|0.323
74041723|NCT02781454|147635677|SUPERIORITY||linear contrast active vs placebo|-2.017||||0.273|TWO_SIDED|95.0|-5.767|1.733|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||1.733|-5.767|0.273
74041724|NCT02781454|147635678|SUPERIORITY||linear contrast active vs placebo|0.708||||0.713|TWO_SIDED|95.0|0.111|4.535|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo||4.535|0.111|0.713
74041725|NCT02781454|147635680|SUPERIORITY||linear contrast active vs placebo|-0.399||||0.601|TWO_SIDED|95.0|-1.966|1.169|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||1.169|-1.966|0.601
74041726|NCT02781454|147635681|SUPERIORITY||linear contrast active vs placebo|-2.734||||0.285|TWO_SIDED|95.0|-7.938|2.471|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||2.471|-7.938|0.285
74011109|NCT01431274|147573253|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0001|TWO_SIDED|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.070|0.023|0.0001
74041727|NCT02372097|147635698|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed AUC(0-168) of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|Least square (LS) mean difference|-0.017|||||TWO_SIDED|90.0|-0.0344|0.0004||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-168) as a dependent variable, and product, group and period as fixed effects.||0.0004|-0.0344|
74041728|NCT02372097|147635699|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed Cmax of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|LS mean difference|-0.1292|||||TWO_SIDED|90.0|-0.2177|-0.0406||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the Cmax as a dependent variable, and product, group and period as fixed effects.||-0.0406|-0.2177|
74041729|NCT02372097|147635700|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.021||||||90.0|-0.0362|-0.0058||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-inf) as a dependent variable, and product, group and period as fixed effects.||-0.0058|-0.0362|
74041730|NCT02372097|147635701|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.375|||||TWO_SIDED|90.0|-0.1452|0.8952||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with Tmax as a dependent variable, and product, group and period as fixed effects.||0.8952|-0.1452|
73879546|NCT03192176|147297613|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|2.24||0.5263|TWO_SIDED|95.0|-5.84|2.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.99|-5.84|0.5263
73879547|NCT03192176|147297613|SUPERIORITY||LSMean differencce|-2.4|STANDARD_ERROR_OF_MEAN|2.24||0.2782|TWO_SIDED|95.0|-6.83|1.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.97|-6.83|0.2782
73879548|NCT03192176|147297613|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|2.24||0.0198|TWO_SIDED|95.0|-9.67|-0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.84|-9.67|0.0198
73879549|NCT03192176|147297613|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.25||0.0417|TWO_SIDED|95.0|-9.05|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.18|-9.05|0.0417
73879550|NCT03192176|147297613|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.16||0.2963|TWO_SIDED|95.0|-6.52|2.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.00|-6.52|0.2963
73879551|NCT03192176|147297613|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|2.09||0.5408|TWO_SIDED|95.0|-5.39|2.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.83|-5.39|0.5408
73879552|NCT03192176|147297613|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|2.07||0.7473|TWO_SIDED|95.0|-4.74|3.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||3.41|-4.74|0.7473
74041731|NCT02372097|147635702|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.0168|||||TWO_SIDED|90.0|-0.0504|0.0169||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the MRT as a dependent variable, and product, group and period as fixed effects.||0.0169|-0.0504|
74041732|NCT02372097|147635703|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1099|||||TWO_SIDED|90.0|0.0235|0.1963||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the λz as a dependent variable, and product, group and period as fixed effects.||0.1963|0.0235|
74041733|NCT03219567|147635724|OTHER|||||||0.35|||||||t-test, 2 sided|||OCT compared to MRI||||0.35
73879553|NCT03192176|147297613|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|2.18||0.9214|TWO_SIDED|95.0|-4.07|4.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.50|-4.07|0.9214
73879554|NCT03192176|147297613|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|2.14||0.9876|TWO_SIDED|95.0|-4.19|4.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.26|-4.19|0.9876
73879555|NCT03192176|147297613|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.18||0.2379|TWO_SIDED|95.0|-6.86|1.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.71|-6.86|0.2379
74041734|NCT01654523|147635759|SUPERIORITY_OR_OTHER||Mean change in the single arm trial|6.695|STANDARD_DEVIATION|5.505|<|0.05|TWO_SIDED|95.0|4.041|9.348|||Paired t-test|||||9.348|4.041|<0.05
74041735|NCT01313208|147635760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.055|TWO_SIDED|95.0|0.99|3.41|||Mantel Haenszel|P-value from Mantel-Haenszel test stratified by participant's baseline methotrexate use (yes or no).|Etanercept/Placebo|||3.41|0.99|0.055
74093541|NCT02856880|147738532|SUPERIORITY_OR_OTHER||LS mean difference|10.86||||0.0072|TWO_SIDED|95.0|3.13|18.59||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||18.59|3.13|0.0072
73879556|NCT03192176|147297613|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|2.18||0.1491|TWO_SIDED|95.0|-7.45|1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.14|-7.45|0.1491
73879557|NCT03192176|147297613|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|2.07||0.956|TWO_SIDED|95.0|-3.96|4.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.19|-3.96|0.9560
73879558|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.96||0.0089|TWO_SIDED|95.0|-9.01|-1.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.30|-9.01|0.0089
74011110|NCT01431274|147573253|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.012||0.0122|TWO_SIDED|95.0|0.007|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.054|0.007|0.0122
74011111|NCT01431274|147573253|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.012||0.0021|TWO_SIDED|95.0|0.014|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.061|0.014|0.0021
74011112|NCT01431274|147573253|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.012||0.0347|TWO_SIDED|95.0|0.002|0.049||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.049|0.002|0.0347
74011113|NCT01431274|147573253|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.032|0.08||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.080|0.032|<0.0001
74041736|NCT01957787|147635802|OTHER|||||||0.41||||||Estimates of the log odds and Wald standard error from a random effects logistic regression model were combined across imputed datasets for reference.|Random effects logistic regression model|||The null hypothesis was tested comparing the lower bound of the Wald 97.5% 1-sided confidence interval for the estimated rate of local tumor control to the performance goal of 84.0%. If the lower bound was greater than 84.0%, the null hypothesis was rejected and the endpoint was considered met.||||0.410
74041737|NCT04046341|147635823|OTHER|||||||0.008||||||A priori statistical significance threshold = p\<.05|McNemar|||||||.008
74041738|NCT04046341|147635824|SUPERIORITY|||||||0.014||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.014
74041739|NCT04046341|147635825|SUPERIORITY|||||||0.013||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.013
74041740|NCT04046341|147635826|SUPERIORITY|||||||0.001||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.001
74041741|NCT04046341|147635827|SUPERIORITY|||||||0.209||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.209
74093542|NCT02856880|147738532|SUPERIORITY_OR_OTHER||LS mean difference|13.77||||0.0009|TWO_SIDED|95.0|6.01|21.53||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||21.53|6.01|0.0009
74093543|NCT02856880|147738532|SUPERIORITY_OR_OTHER||LS mean difference|8.44||||0.0286|TWO_SIDED|95.0|0.93|15.95||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||15.95|0.93|0.0286
74093544|NCT02856880|147738532|SUPERIORITY_OR_OTHER||LS mean difference|5.32||||0.1573|TWO_SIDED|95.0|-2.15|12.79||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||12.79|-2.15|0.1573
74041742|NCT00435994|147635831|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||0.0020
74041743|NCT00435994|147635832|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||.0020
74041744|NCT03846219|147635848|SUPERIORITY||rate ratio|0.38||||0.0002|TWO_SIDED|95.0|0.22|0.64||A one-sided alpha level of 0.1 was used.|generalized linear model|Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1).|Rate ratio of 45 mg IMU-838 / placebo|H0: cumulative number of CUA MRI lesions up to Week 24 with 45 mg IMU-838 equal to or higher than that with placebo. A generalized linear model with a negative binomial distribution and logarithmic link function was used. Log transformation of time from 1st IMP dose to date of last MRI assessment was used as offset term. 51 patients per group were necessary to have 80% power to detect a difference of 3.5 in mean event rate with a significance level 0.1, 1-sided.||0.64|0.22|0.0002
74041745|NCT03846219|147635849|SUPERIORITY||Rate ratio|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.53||A hierarchical testing procedure with a one-sided alpha level of 0.1 was used.|Generalized linear model|Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1).|Rate ratio of 30 mg IMU-838 / placebo|A generalized linear model with a negative binomial distribution and logarithmic link function was used. Log transformation of time from 1st IMP dose to date of last MRI assessment was used as offset term.||0.53|0.17|<.0001
74041746|NCT05109702|147635905|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.094||0.764|TWO_SIDED|95.0|-0.214|0.157|||MMRM|||The Least Square (LS) means, LS mean difference, Standard Errors (SEs), two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the Mixed model repeated measures (MMRM) model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.157|-0.214|0.764
74093545|NCT02856880|147738532|SUPERIORITY_OR_OTHER||LS mean difference|-29.32|||<|0.0001|TWO_SIDED|95.0|-37.2|-21.43||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||-21.43|-37.20|<0.0001
74093546|NCT02856880|147738532|SUPERIORITY_OR_OTHER||LS mean difference|31.74|||<|0.0001|TWO_SIDED|95.0|24.18|39.3||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||39.30|24.18|<0.0001
74093547|NCT02856880|147738532|SUPERIORITY_OR_OTHER||LS mean difference|2.42||||0.5174|TWO_SIDED|95.0|-5.08|9.92||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||9.92|-5.08|0.5174
74093548|NCT02856880|147738533|SUPERIORITY_OR_OTHER||LS mean difference|-233.22|||<|0.0001|TWO_SIDED|95.0|-332.88|-133.55||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-133.55|-332.88|<0.0001
74093549|NCT02856880|147738533|SUPERIORITY_OR_OTHER||LS mean difference|35.53||||0.5018|TWO_SIDED|95.0|-69.9|140.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||140.96|-69.90|0.5018
74011114|NCT01431274|147573253|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4407|TWO_SIDED|95.0|-0.014|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.033|-0.014|0.4407
74011115|NCT01431274|147573253|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.012||0.1777|TWO_SIDED|95.0|-0.007|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.040|-0.007|0.1777
74011116|NCT01431274|147573253|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.012||0.5641|TWO_SIDED|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.017|-0.031|0.5641
74011117|NCT01431274|147573254|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.104|0.057|<0.0001
74011118|NCT01431274|147573254|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.051|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.099|0.051|<0.0001
74011119|NCT01431274|147573254|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.012||0.0018|TWO_SIDED|95.0|0.014|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.062|0.014|0.0018
74011120|NCT01431274|147573254|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0517|TWO_SIDED|95.0|0.0|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.000|0.0517
74011121|NCT01431274|147573254|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.012||0.0072|TWO_SIDED|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.056|0.009|0.0072
74011122|NCT01431274|147573254|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.012||0.0005|TWO_SIDED|95.0|0.019|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.066|0.019|0.0005
74011123|NCT01431274|147573254|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.042|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.090|0.042|<0.0001
74011124|NCT01431274|147573254|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.012||0.6619|TWO_SIDED|95.0|-0.018|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.029|-0.018|0.6619
74011125|NCT01431274|147573254|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2401|TWO_SIDED|95.0|-0.01|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.038|-0.010|0.2401
74011126|NCT01431274|147573254|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4601|TWO_SIDED|95.0|-0.033|0.015||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.015|-0.033|0.4601
74011127|NCT01431274|147573255|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.064|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.112|0.064|<0.0001
74011128|NCT01431274|147573255|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.052|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.100|0.052|<0.0001
74011129|NCT01431274|147573255|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.094|0.046|<0.0001
74011130|NCT01431274|147573255|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.027|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|0.027|<0.0001
74011131|NCT01431274|147573255|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.082||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.082|0.034|<0.0001
74011132|NCT01431274|147573255|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.012||0.1405|TWO_SIDED|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.042|-0.006|0.1405
74041747|NCT05109702|147635906|SUPERIORITY||LS Mean Difference|4.34|STANDARD_ERROR_OF_MEAN|2.969||0.144|TWO_SIDED|95.0|-1.483|10.155|||MMRM|||The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.155|-1.483|0.144
74093550|NCT02856880|147738533|SUPERIORITY_OR_OTHER||LS mean difference|-24.73||||0.6325|TWO_SIDED|95.0|-128.07|78.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||78.61|-128.07|0.6325
74093551|NCT02856880|147738533|SUPERIORITY_OR_OTHER||LS mean difference|-60.26||||0.2427|TWO_SIDED|95.0|-162.72|42.21||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||42.21|-162.72|0.2427
74093552|NCT02856880|147738533|SUPERIORITY_OR_OTHER||LS mean difference|1.05||||0.9834|TWO_SIDED|95.0|-100.5|102.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||102.61|-100.50|0.9834
74093553|NCT02856880|147738533|SUPERIORITY_OR_OTHER||LS mean difference|-61.31||||0.2226|TWO_SIDED|95.0|-161.14|38.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||38.52|-161.14|0.2226
74093554|NCT02856880|147738533|SUPERIORITY_OR_OTHER||LS mean difference|268.74|||<|0.0001|TWO_SIDED|95.0|165.98|371.51||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is second named treatment(non-SLS negative control) minus first named treatment (SLS negative control) such that a negative difference indicates a greater inhibition of plaque|||371.51|165.98|<0.0001
74093555|NCT02856880|147738533|SUPERIORITY_OR_OTHER||LS mean difference|-293.47|||<|0.0001|TWO_SIDED|95.0|-396.03|-190.91||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-190.91|-396.03|<0.0001
74093556|NCT02856880|147738533|SUPERIORITY_OR_OTHER||LS mean difference|-294.53|||<|0.0001|TWO_SIDED|95.0|-395.43|-193.62||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-193.62|-395.43|<0.0001
74093557|NCT02856880|147738533|SUPERIORITY_OR_OTHER||LS mean difference|-25.78||||0.6086|TWO_SIDED|95.0|-126.53|74.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||74.96|-126.53|0.6086
74093558|NCT02856880|147738534|SUPERIORITY_OR_OTHER||LS mean difference|-273.92||||0.6664|TWO_SIDED|95.0|-1550.45|1002.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1002.61|-1550.45|0.6664
74093559|NCT02856880|147738534|SUPERIORITY_OR_OTHER||LS mean difference|674.06||||0.3249|TWO_SIDED|95.0|-692.21|2040.33||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2040.33|-692.21|0.3249
74093560|NCT02856880|147738534|SUPERIORITY_OR_OTHER||LS mean difference|677.09||||0.3544|TWO_SIDED|95.0|-784.16|2138.35||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2138.35|-784.16|0.3544
74093561|NCT02856880|147738534|SUPERIORITY_OR_OTHER||LS mean difference|3.04||||0.9967|TWO_SIDED|95.0|-1469.45|1475.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1475.52|-1469.45|0.9967
74093562|NCT02856880|147738534|SUPERIORITY_OR_OTHER||LS mean difference|766.64||||0.2976|TWO_SIDED|95.0|-703.26|2236.54||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2236.54|-703.26|0.2976
74093563|NCT02856880|147738534|SUPERIORITY_OR_OTHER||LS mean difference|-763.6||||0.2702|TWO_SIDED|95.0|-2144.45|617.25||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||617.25|-2144.45|0.2702
73887985|NCT01746901|147309528|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8512|TWO_SIDED|95.0|-1.6|1.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.3|-1.6|0.8512
73879559|NCT03192176|147297614|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|-12.22|-4.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-4.48|-12.22|<0.0001
73879560|NCT03192176|147297614|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-13.06|-5.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-5.34|-13.06|<0.0001
73879561|NCT03192176|147297614|SUPERIORITY||LSMean difference|-10.7|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-14.58|-6.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-6.75|-14.58|<0.0001
73879562|NCT03192176|147297614|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|2.0||0.063|TWO_SIDED|95.0|-7.65|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.20|-7.65|0.0630
73879563|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.97||0.0003|TWO_SIDED|95.0|-11.04|-3.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.30|-11.04|0.0003
73879564|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.96||0.0007|TWO_SIDED|95.0|-10.53|-2.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.84|-10.53|0.0007
73879565|NCT03192176|147297614|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.98||0.0231|TWO_SIDED|95.0|-8.43|-0.63||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.63|-8.43|0.0231
73879566|NCT03192176|147297614|SUPERIORITY||LSMean difference|-8.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-11.94|-4.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.09|-11.94|<0.0001
74011133|NCT01431274|147573255|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.045|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.093|0.045|<0.0001
74011134|NCT01431274|147573255|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3118|TWO_SIDED|95.0|-0.012|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.036|-0.012|0.3118
74011135|NCT01431274|147573255|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.019|STANDARD_ERROR_OF_MEAN|0.012||0.1171|TWO_SIDED|95.0|-0.005|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.043|-0.005|0.1171
74011136|NCT01431274|147573255|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.012||0.5759|TWO_SIDED|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.017|-0.031|0.5759
74011137|NCT01431274|147573256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.079|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.055|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.103|0.055|<0.0001
74011138|NCT01431274|147573256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.038|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.086|0.038|<0.0001
74041748|NCT05109702|147635907|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.094||0.056|TWO_SIDED|95.0|-0.005|0.363|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.363|-0.005|0.056
74041749|NCT05109702|147635907|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.094||0.064|TWO_SIDED|95.0|-0.01|0.359|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.359|-0.010|0.064
74041750|NCT05109702|147635907|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.095||0.328|TWO_SIDED|95.0|-0.093|0.279|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.279|-0.093|0.328
74041751|NCT05109702|147635907|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.096||0.837|TWO_SIDED|95.0|-0.208|0.168|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.168|-0.208|0.837
74041752|NCT05109702|147635908|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.079||0.686|TWO_SIDED|95.0|-0.123|0.187|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.187|-0.123|0.686
74041753|NCT05109702|147635908|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.079||0.68|TWO_SIDED|95.0|-0.123|0.188|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.188|-0.123|0.680
74041754|NCT05109702|147635908|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.529|TWO_SIDED|95.0|-0.107|0.207|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.207|-0.107|0.529
74041755|NCT05109702|147635908|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.081||0.745|TWO_SIDED|95.0|-0.132|0.185|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.185|-0.132|0.745
74041756|NCT05109702|147635909|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.085||0.765|TWO_SIDED|95.0|-0.141|0.192|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.192|-0.141|0.765
74041757|NCT05109702|147635909|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.085||0.053|TWO_SIDED|95.0|-0.002|0.331|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.331|-0.002|0.053
74041758|NCT05109702|147635909|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.086||0.552|TWO_SIDED|95.0|-0.117|0.219|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.219|-0.117|0.552
74041759|NCT05109702|147635909|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.087||0.593|TWO_SIDED|95.0|-0.216|0.124|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.124|-0.216|0.593
74041760|NCT05109702|147635910|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.087||0.884|TWO_SIDED|95.0|-0.183|0.158|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.158|-0.183|0.884
74093564|NCT02856880|147738534|SUPERIORITY_OR_OTHER||LS mean difference|947.97||||0.1511|TWO_SIDED|95.0|-361.95|2257.9||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2257.90|-361.95|0.1511
74093565|NCT02856880|147738534|SUPERIORITY_OR_OTHER||LS mean difference|-270.88||||0.6998|TWO_SIDED|95.0|-1680.58|1138.82||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1138.82|-1680.58|0.6998
74093566|NCT02856880|147738534|SUPERIORITY_OR_OTHER||LS mean difference|-1037.52||||0.121|TWO_SIDED|95.0|-2361.33|286.29||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant -level pre-treatment values and period minus participant -level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||286.29|-2361.33|0.1210
74093567|NCT02856880|147738534|SUPERIORITY_OR_OTHER||LS mean difference|-89.54||||0.8935|TWO_SIDED|95.0|-1439.5|1260.41||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1260.41|-1439.50|0.8935
74093568|NCT02944383|147738538|SUPERIORITY||Median Difference (Net)|-19.02||||0.0063|TWO_SIDED|95.0|-33.07|-4.25|||Ranked ANCOVA|Randomized treatment group \& randomized baseline statin (yes or no) are included as factors, \& outcome (ranked) at baseline is included as covariate.|Estimates generated from Hodges-Lehmann method.|||-4.25|-33.07|0.0063
74093569|NCT02944383|147738538|SUPERIORITY||Median Difference (Net)|-7.63||||0.235|TWO_SIDED|95.0|-25.88|7.05|||Ranked ANCOVA|Randomized treatment group \& randomized baseline statin (yes or no) are included as factors, \& outcome (ranked) at baseline is included as covariate.|Estimates generated from Hodges-Lehmann method.|||7.05|-25.88|0.2350
74093570|NCT02944383|147738539|OTHER|||||||0.1663||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1663
74093571|NCT02944383|147738539|SUPERIORITY|||||||0.6195||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6195
74093572|NCT02944383|147738539|SUPERIORITY|||||||0.0436||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0436
74093573|NCT02944383|147738539|SUPERIORITY|||||||0.5||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.5000
74093574|NCT02944383|147738539|SUPERIORITY|||||||0.0007||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0007
74093575|NCT02944383|147738539|SUPERIORITY|||||||0.1161||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1161
74093576|NCT02944383|147738539|SUPERIORITY|||||||0.183||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1830
74093577|NCT02944383|147738539|SUPERIORITY|||||||0.8762||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8762
74093578|NCT02944383|147738540|SUPERIORITY|||||||0.178||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1780
74093579|NCT02944383|147738540|SUPERIORITY|||||||0.7615||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.7615
74093580|NCT02944383|147738540|SUPERIORITY|||||||0.0162||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0162
74093581|NCT02944383|147738540|SUPERIORITY|||||||0.371||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.3710
74093582|NCT02944383|147738540|SUPERIORITY|||||||0.001||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
74093583|NCT02944383|147738540|SUPERIORITY|||||||0.0988||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0988
74093584|NCT02944383|147738540|SUPERIORITY|||||||0.2594||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2594
74093585|NCT02944383|147738540|SUPERIORITY|||||||0.9099||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9099
74093586|NCT02944383|147738540|SUPERIORITY|||||||0.0219||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0219
74093587|NCT02944383|147738540|SUPERIORITY|||||||0.3494||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3494
74093588|NCT02944383|147738541|SUPERIORITY|||||||0.0391||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0391
74093589|NCT02944383|147738541|SUPERIORITY|||||||0.2455||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2455
74093590|NCT02944383|147738541|SUPERIORITY|||||||0.026||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0260
74093591|NCT02944383|147738541|SUPERIORITY|||||||0.5704||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.5704
74093592|NCT02944383|147738541|SUPERIORITY|||||||0.0009||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0009
74093593|NCT02944383|147738541|SUPERIORITY|||||||0.0846||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0846
74093594|NCT02944383|147738541|SUPERIORITY|||||||0.1763||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1763
74093595|NCT02944383|147738541|SUPERIORITY|||||||0.5576||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5576
74093596|NCT02944383|147738541|SUPERIORITY||Median Difference (Net)|-14.66||||0.0086|TWO_SIDED|95.0|-24.68|-4.39||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-4.39|-24.68|0.0086
74093597|NCT02944383|147738541|SUPERIORITY||Mean Difference (Net)|-5.06||||0.1516|TWO_SIDED|95.0|-15.02|3.64||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||3.64|-15.02|0.1516
74093598|NCT02944383|147738542|SUPERIORITY|||||||0.0386||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0386
74093599|NCT02944383|147738542|SUPERIORITY|||||||0.1206||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1206
74093600|NCT02944383|147738542|SUPERIORITY|||||||0.0364||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0364
74093601|NCT02944383|147738542|SUPERIORITY|||||||0.4312||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.4312
74093602|NCT02944383|147738542|SUPERIORITY|||||||0.001||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
74093603|NCT02944383|147738542|SUPERIORITY|||||||0.0407||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0407
74093604|NCT02944383|147738542|SUPERIORITY|||||||0.1433||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1433
73879567|NCT03192176|147297614|SUPERIORITY||LSMean differencce|-8.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-11.87|-4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.05|-11.87|<0.0001
73879568|NCT03192176|147297614|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.02|<|0.0001|TWO_SIDED|95.0|-13.21|-5.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-5.26|-13.21|<0.0001
73879569|NCT03192176|147297614|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|2.02||0.0177|TWO_SIDED|95.0|-8.8|-0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.84|-8.80|0.0177
73879570|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.99||0.0012|TWO_SIDED|95.0|-10.45|-2.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.60|-10.45|0.0012
73879571|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|2.04||0.0072|TWO_SIDED|95.0|-9.26|-2.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.64|-9.26|0.0072
73879572|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|2.04||0.0044|TWO_SIDED|95.0|-9.86|-1.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.84|-9.86|0.0044
73879573|NCT03192176|147297614|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-13.27|-5.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-5.21|-13.27|<0.0001
74041761|NCT05109702|147635910|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.474|TWO_SIDED|95.0|-0.109|0.233|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.233|-0.109|0.474
74041762|NCT05109702|147635910|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.088||0.202|TWO_SIDED|95.0|-0.06|0.285|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.285|-0.060|0.202
74093605|NCT02944383|147738542|SUPERIORITY|||||||0.2866||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2866
74093606|NCT02944383|147738542|SUPERIORITY|||||||0.0056||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0056
73879574|NCT03192176|147297614|SUPERIORITY||LSMean difference|-8.6|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.57|-4.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.55|-12.57|<0.0001
73879575|NCT03192176|147297614|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.29|-6.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-6.11|-14.29|<0.0001
73879576|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|2.08||0.0009|TWO_SIDED|95.0|-11.04|-2.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.87|-11.04|0.0009
73879577|NCT03192176|147297614|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-12.44|-4.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.39|-12.44|<0.0001
73879578|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|2.04||0.0012|TWO_SIDED|95.0|-10.65|-2.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.64|-10.65|0.0012
73879579|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|2.04||0.0053|TWO_SIDED|95.0|-9.72|-1.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.71|-9.72|0.0053
74041763|NCT05109702|147635910|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.089||0.013|TWO_SIDED|95.0|0.047|0.396|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.396|0.047|0.013
74041764|NCT05109702|147635911|OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.604|TWO_SIDED|95.0|-0.131|0.224|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.224|-0.131|0.604
74041765|NCT05109702|147635911|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.091||0.519|TWO_SIDED|95.0|-0.119|0.236|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.236|-0.119|0.519
74041766|NCT05109702|147635911|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.092||0.299|TWO_SIDED|95.0|-0.085|0.275|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.275|-0.085|0.299
74041767|NCT05109702|147635911|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.093||0.124|TWO_SIDED|95.0|-0.039|0.324|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.324|-0.039|0.124
74041768|NCT05109702|147635912|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.215||0.293|TWO_SIDED|95.0|-0.196|0.647|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.647|-0.196|0.293
74041769|NCT05109702|147635912|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.215||0.094|TWO_SIDED|95.0|-0.062|0.783|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.783|-0.062|0.094
74041770|NCT05109702|147635912|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.217||0.404|TWO_SIDED|95.0|-0.245|0.608|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.608|-0.245|0.404
74041771|NCT05109702|147635912|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.22||0.806|TWO_SIDED|95.0|-0.485|0.377|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.377|-0.485|0.806
74041772|NCT05109702|147635913|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.157||0.824|TWO_SIDED|95.0|-0.273|0.343|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.343|-0.273|0.824
74041773|NCT05109702|147635913|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.157||0.437|TWO_SIDED|95.0|-0.186|0.431|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.431|-0.186|0.437
74041774|NCT05109702|147635913|SUPERIORITY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.159||0.193|TWO_SIDED|95.0|-0.105|0.519|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.519|-0.105|0.193
74093607|NCT02944383|147738542|SUPERIORITY|||||||0.0789||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0789
74093608|NCT02944383|147738543|SUPERIORITY|||||||0.0277||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0277
74011139|NCT01431274|147573256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.061|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.037|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.085|0.037|<0.0001
74011140|NCT01431274|147573256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|0.022|0.071||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.071|0.022|0.0002
74011141|NCT01431274|147573256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.044|STANDARD_ERROR_OF_MEAN|0.012||0.0004|TWO_SIDED|95.0|0.019|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.068|0.019|0.0004
74041775|NCT05109702|147635913|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.161||0.024|TWO_SIDED|95.0|0.048|0.679|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.679|0.048|0.024
74041776|NCT05109702|147635914|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.329||0.43|TWO_SIDED|95.0|-0.386|0.907|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.907|-0.386|0.430
74041777|NCT05109702|147635914|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.33||0.143|TWO_SIDED|95.0|-0.164|1.132|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.132|-0.164|0.143
74041778|NCT05109702|147635914|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.333||0.245|TWO_SIDED|95.0|-0.267|1.042|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.042|-0.267|0.245
74041779|NCT05109702|147635914|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.337||0.359|TWO_SIDED|95.0|-0.352|0.97|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.970|-0.352|0.359
74041780|NCT05109702|147635915|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.067||0.016|TWO_SIDED|95.0|0.03|0.292|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.292|0.030|0.016
74041781|NCT05109702|147635915|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.067||0.099|TWO_SIDED|95.0|-0.021|0.242|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.242|-0.021|0.099
74041782|NCT05109702|147635915|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.068||0.493|TWO_SIDED|95.0|-0.086|0.179|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.179|-0.086|0.493
74093609|NCT02944383|147738543|SUPERIORITY|||||||0.2502||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2502
73879580|NCT03192176|147297614|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.77|-4.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.73|-12.77|<0.0001
74011142|NCT01431274|147573256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.012||0.136|TWO_SIDED|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.042|-0.006|0.1360
73879581|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|2.04||0.0001|TWO_SIDED|95.0|-11.84|-3.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.84|-11.84|0.0001
73879582|NCT03192176|147297614|SUPERIORITY||LSMean difference|-10.0|STANDARD_ERROR_OF_MEAN|2.07|<|0.0001|TWO_SIDED|95.0|-14.12|-5.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-5.96|-14.12|<0.0001
73879583|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|2.07||0.001|TWO_SIDED|95.0|-10.92|-2.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.78|-10.92|0.0010
73879584|NCT03192176|147297614|SUPERIORITY||LSMean difference|-8.5|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.49|-4.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.46|-12.49|<0.0001
73879585|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|2.03||0.0005|TWO_SIDED|95.0|-11.12|-3.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.13|-11.12|0.0005
73879586|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.93||0.0057|TWO_SIDED|95.0|-9.15|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.58|-9.15|0.0057
74011143|NCT01431274|147573256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.041|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|0.041|<0.0001
74011144|NCT01431274|147573256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.012||0.1617|TWO_SIDED|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.041|-0.007|0.1617
73879587|NCT03192176|147297614|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-12.15|-4.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.56|-12.15|<0.0001
73879588|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-11.68|-4.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.08|-11.68|<0.0001
73879589|NCT03192176|147297614|SUPERIORITY||LSMean difference|-9.8|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-13.66|-5.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-5.93|-13.66|<0.0001
73879590|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.95||0.0007|TWO_SIDED|95.0|-10.54|-2.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.85|-10.54|0.0007
73879591|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-11.55|-3.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-3.95|-11.55|<0.0001
74093610|NCT02944383|147738543|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0161
73879592|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.92||0.001|TWO_SIDED|95.0|-10.16|-2.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.60|-10.16|0.0010
73879593|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.91||0.0064|TWO_SIDED|95.0|-8.99|-1.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.48|-8.99|0.0064
73879594|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.91||0.0002|TWO_SIDED|95.0|-10.94|-3.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.42|-10.94|0.0002
74011145|NCT01431274|147573256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2476|TWO_SIDED|95.0|-0.01|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.010|0.2476
74011146|NCT01431274|147573256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.012||0.8083|TWO_SIDED|95.0|-0.021|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.027|-0.021|0.8083
74011147|NCT01431274|147573257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.075|0.124||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.124|0.075|<0.0001
74011148|NCT01431274|147573257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.039|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.088|0.039|<0.0001
74041783|NCT05109702|147635915|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.068||0.987|TWO_SIDED|95.0|-0.133|0.135|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.135|-0.133|0.987
74041784|NCT05109702|147635916|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.072||0.655|TWO_SIDED|95.0|-0.109|0.173|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.173|-0.109|0.655
74041785|NCT05109702|147635916|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.072||0.826|TWO_SIDED|95.0|-0.157|0.125|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.125|-0.157|0.826
74041786|NCT05109702|147635916|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.073||0.861|TWO_SIDED|95.0|-0.155|0.13|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.130|-0.155|0.861
74041787|NCT05109702|147635916|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.073||0.556|TWO_SIDED|95.0|-0.101|0.187|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.187|-0.101|0.556
74041788|NCT05109702|147635917|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.527|TWO_SIDED|95.0|-0.116|0.226|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.226|-0.116|0.527
74093611|NCT02944383|147738543|SUPERIORITY|||||||0.6567||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.6567
74093612|NCT02944383|147738543|SUPERIORITY|||||||0.001||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
74093613|NCT02944383|147738543|SUPERIORITY|||||||0.1257||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1257
74011149|NCT01431274|147573257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.100|0.051|<0.0001
74093614|NCT02944383|147738543|SUPERIORITY|||||||0.144||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1440
74041789|NCT05109702|147635917|SUPERIORITY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.087||0.005|TWO_SIDED|95.0|0.077|0.418|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.418|0.077|0.005
74041790|NCT05109702|147635917|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.088||0.92|TWO_SIDED|95.0|-0.164|0.181|||MMRM|||Wek 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.181|-0.164|0.920
74041791|NCT05109702|147635917|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.089||0.286|TWO_SIDED|95.0|-0.08|0.269|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.269|-0.080|0.286
74041792|NCT05109702|147635918|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.098||0.071|TWO_SIDED|95.0|-0.015|0.369|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.369|-0.015|0.071
74041793|NCT05109702|147635918|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.098||0.384|TWO_SIDED|95.0|-0.107|0.278|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.278|-0.107|0.384
74041794|NCT05109702|147635918|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.099||0.391|TWO_SIDED|95.0|-0.109|0.28|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.280|-0.109|0.391
74041795|NCT05109702|147635918|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.802|TWO_SIDED|95.0|-0.171|0.222|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.222|-0.171|0.802
74041796|NCT05109702|147635919|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.098||0.884|TWO_SIDED|95.0|-0.206|0.178|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.178|-0.206|0.884
74041797|NCT05109702|147635919|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.098||0.303|TWO_SIDED|95.0|-0.091|0.293|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.293|-0.091|0.303
74041798|NCT05109702|147635919|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.099||0.554|TWO_SIDED|95.0|-0.135|0.253|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.253|-0.135|0.554
74093615|NCT02944383|147738543|SUPERIORITY|||||||0.7642||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7642
74093616|NCT02944383|147738543|SUPERIORITY||Median Difference (Net)|-16.4||||0.0107|TWO_SIDED|95.0|-28.31|-4.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-4.51|-28.31|0.0107
74093617|NCT02944383|147738543|SUPERIORITY||Median Difference (Net)|-5.32||||0.2466|TWO_SIDED|95.0|-16.73|5.52||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.52|-16.73|0.2466
74011150|NCT01431274|147573257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.023|0.072||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.072|0.023|0.0001
74011151|NCT01431274|147573257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.012||0.0014|TWO_SIDED|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.064|0.015|0.0014
74093618|NCT02944383|147738544|SUPERIORITY|||||||0.0211||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0211
74093619|NCT02944383|147738544|SUPERIORITY|||||||0.1304||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1304
74011152|NCT01431274|147573257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0554|TWO_SIDED|95.0|-0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.048|-0.001|0.0554
74011153|NCT01431274|147573257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.047|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.096|0.047|<0.0001
74011154|NCT01431274|147573257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.0041|TWO_SIDED|95.0|0.011|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.060|0.011|0.0041
74011155|NCT01431274|147573257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.013||0.0248|TWO_SIDED|95.0|0.004|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.053|0.004|0.0248
74011156|NCT01431274|147573257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5338|TWO_SIDED|95.0|-0.017|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.032|-0.017|0.5338
74011157|NCT01431274|147573258|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.024||0.0017|TWO_SIDED|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.029|0.0017
74011158|NCT01431274|147573258|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.138|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.09|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.186|0.090|<0.0001
74041799|NCT05109702|147635919|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.051|TWO_SIDED|95.0|-0.001|0.391|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.391|-0.001|0.051
74041800|NCT05109702|147635920|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.17||0.131|TWO_SIDED|95.0|-0.077|0.591|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.591|-0.077|0.131
74041801|NCT05109702|147635920|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.171||0.04|TWO_SIDED|95.0|0.016|0.685|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.685|0.016|0.040
74011159|NCT01431274|147573258|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.024||0.0426|TWO_SIDED|95.0|0.002|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.098|0.002|0.0426
74011160|NCT01431274|147573258|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.074|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.170|0.074|<0.0001
74011161|NCT01431274|147573258|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.063|0.159||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.159|0.063|<0.0001
74011162|NCT01431274|147573258|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.025||0.2661|TWO_SIDED|95.0|-0.021|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|-0.021|0.2661
74011163|NCT01431274|147573258|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.102|0.198||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.198|0.102|<0.0001
74011164|NCT01431274|147573258|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.061|STANDARD_ERROR_OF_MEAN|0.024||0.0119|TWO_SIDED|95.0|-0.109|-0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.014|-0.109|0.0119
74011165|NCT01431274|147573258|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.073|STANDARD_ERROR_OF_MEAN|0.024||0.0029|TWO_SIDED|95.0|-0.121|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.025|-0.121|0.0029
74011166|NCT01431274|147573258|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.024||0.6408|TWO_SIDED|95.0|-0.036|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.059|-0.036|0.6408
74011167|NCT01431274|147573259|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.221|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.173|0.27||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.270|0.173|<0.0001
74011168|NCT01431274|147573259|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.193|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.145|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.145|<0.0001
74011169|NCT01431274|147573259|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.185|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.136|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.233|0.136|<0.0001
74011170|NCT01431274|147573259|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.114|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.065|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.162|0.065|<0.0001
74011171|NCT01431274|147573259|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.157|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.108|0.205||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.205|0.108|<0.0001
74093620|NCT02944383|147738544|SUPERIORITY|||||||0.0318||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0318
74093621|NCT02944383|147738544|SUPERIORITY|||||||0.4607||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.4607
74093622|NCT02944383|147738544|SUPERIORITY|||||||0.0012||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0012
74093623|NCT02944383|147738544|SUPERIORITY|||||||0.0592||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0592
74093624|NCT02944383|147738544|SUPERIORITY|||||||0.117||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1170
74011172|NCT01431274|147573259|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.025||0.1355|TWO_SIDED|95.0|-0.012|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.085|-0.012|0.1355
74011173|NCT01431274|147573259|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.151|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.102|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.199|0.102|<0.0001
74093625|NCT02944383|147738544|SUPERIORITY|||||||0.3138||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3138
74093626|NCT02944383|147738544|SUPERIORITY|||||||0.009||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0090
74011174|NCT01431274|147573259|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.025||0.2562|TWO_SIDED|95.0|-0.02|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.076|-0.020|0.2562
74093627|NCT02944383|147738544|SUPERIORITY|||||||0.1317||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1317
74093628|NCT02944383|147738545|SUPERIORITY|||||||0.2395||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2395
74093629|NCT02944383|147738545|SUPERIORITY|||||||0.638||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6380
74093630|NCT02944383|147738545|SUPERIORITY|||||||0.7468||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.7468
74093631|NCT02944383|147738545|SUPERIORITY|||||||0.8483||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.8483
74093632|NCT02944383|147738545|SUPERIORITY|||||||0.0008||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0008
74093633|NCT02944383|147738545|SUPERIORITY|||||||0.0938||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0938
74093634|NCT02944383|147738545|SUPERIORITY|||||||0.3201||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3201
74093635|NCT02944383|147738545|SUPERIORITY|||||||0.901||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9010
73879595|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.92||0.0001|TWO_SIDED|95.0|-11.29|-3.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.75|-11.29|0.0001
73879596|NCT03192176|147297614|SUPERIORITY||LSMean difference|-8.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-12.69|-5.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-5.03|-12.69|<0.0001
73879597|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.94||0.003|TWO_SIDED|95.0|-9.62|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.99|-9.62|0.0030
73879598|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|1.92||0.0002|TWO_SIDED|95.0|-10.92|-3.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.37|-10.92|0.0002
73879599|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.9||0.0013|TWO_SIDED|95.0|-9.91|-2.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.42|-9.91|0.0013
74093636|NCT02944383|147738545|SUPERIORITY||Median Difference (Net)|-19.31||||0.0156|TWO_SIDED|95.0|-39.06|-1.49||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.49|-39.06|0.0156
74093637|NCT02944383|147738545|SUPERIORITY||Median Difference (Net)|-5.98||||0.3456|TWO_SIDED|95.0|-28.51|17.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||17.26|-28.51|0.3456
74093638|NCT02944383|147738546|SUPERIORITY|||||||0.3714||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.3714
74093639|NCT02944383|147738546|SUPERIORITY|||||||0.4415||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.4415
74093640|NCT02944383|147738546|SUPERIORITY|||||||0.7902||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.7902
74093641|NCT02944383|147738546|SUPERIORITY|||||||0.6999||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.6999
74093642|NCT02944383|147738546|SUPERIORITY|||||||0.0015||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0015
74093643|NCT02944383|147738546|SUPERIORITY|||||||0.0796||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0796
73879600|NCT03192176|147297614|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.94||0.0137|TWO_SIDED|95.0|-8.61|-0.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.99|-8.61|0.0137
73879601|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.4|STANDARD_ERROR_OF_MEAN|1.94||0.0002|TWO_SIDED|95.0|-11.24|-3.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.60|-11.24|0.0002
74011175|NCT01431274|147573259|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.025||0.0041|TWO_SIDED|95.0|0.022|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.119|0.022|0.0041
73879602|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.95||0.0004|TWO_SIDED|95.0|-10.79|-3.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.13|-10.79|0.0004
73879603|NCT03192176|147297614|SUPERIORITY||LSMean difference|-8.9|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-12.74|-4.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-4.97|-12.74|<0.0001
74011176|NCT01431274|147573259|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.043|STANDARD_ERROR_OF_MEAN|0.025||0.0815|TWO_SIDED|95.0|-0.091|0.005||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.005|-0.091|0.0815
74011177|NCT01431274|147573260|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.195|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.149|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.149|<0.0001
74011178|NCT01431274|147573260|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.107|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.199|0.107|<0.0001
74011179|NCT01431274|147573260|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.174|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.128|0.221||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.221|0.128|<0.0001
74011180|NCT01431274|147573260|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.107|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.061|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.154|0.061|<0.0001
74011181|NCT01431274|147573260|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.086|0.178||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.178|0.086|<0.0001
74011182|NCT01431274|147573260|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.024||0.3727|TWO_SIDED|95.0|-0.025|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.067|-0.025|0.3727
74011183|NCT01431274|147573260|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.082|0.175||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.175|0.082|<0.0001
74011184|NCT01431274|147573260|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.024||0.0744|TWO_SIDED|95.0|-0.004|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|-0.004|0.0744
74011185|NCT01431274|147573260|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.024||0.0047|TWO_SIDED|95.0|0.021|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.114|0.021|0.0047
74011186|NCT01431274|147573260|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.025|STANDARD_ERROR_OF_MEAN|0.024||0.2945|TWO_SIDED|95.0|-0.071|0.022||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.022|-0.071|0.2945
74011187|NCT01431274|147573261|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.205|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.155|0.255||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.255|0.155|<0.0001
74093644|NCT02944383|147738546|SUPERIORITY|||||||0.4225||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4225
74093645|NCT02944383|147738546|SUPERIORITY|||||||0.7687||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7687
73879604|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.97||0.0028|TWO_SIDED|95.0|-9.82|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.07|-9.82|0.0028
74041802|NCT05109702|147635920|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.172||0.767|TWO_SIDED|95.0|-0.287|0.389|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.389|-0.287|0.767
74041803|NCT05109702|147635920|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.174||0.41|TWO_SIDED|95.0|-0.198|0.485|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.485|-0.198|0.410
74041804|NCT05109702|147635921|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.17||0.324|TWO_SIDED|95.0|-0.166|0.501|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.501|-0.166|0.324
74041805|NCT05109702|147635921|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.262|TWO_SIDED|95.0|-0.143|0.525|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.525|-0.143|0.262
74041806|NCT05109702|147635921|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.172||0.391|TWO_SIDED|95.0|-0.19|0.485|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.485|-0.190|0.391
74041807|NCT05109702|147635921|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.174||0.192|TWO_SIDED|95.0|-0.114|0.568|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.568|-0.114|0.192
74041808|NCT05109702|147635922|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.29||0.14|TWO_SIDED|95.0|-0.141|0.999|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.999|-0.141|0.140
74041809|NCT05109702|147635922|SUPERIORITY||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.291||0.061|TWO_SIDED|95.0|-0.025|1.117|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.117|-0.025|0.061
74093646|NCT02944383|147738546|SUPERIORITY|||||||0.0437||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0437
74093647|NCT02944383|147738546|SUPERIORITY|||||||0.2735||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.2735
74093648|NCT02944383|147738547|SUPERIORITY|||||||0.1042||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1042
74093649|NCT02944383|147738547|SUPERIORITY|||||||0.6204||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6204
74093650|NCT02944383|147738547|SUPERIORITY|||||||0.8659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.8659
74093651|NCT02944383|147738547|SUPERIORITY|||||||0.9658||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9658
74093652|NCT02944383|147738547|SUPERIORITY|||||||0.8238||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8238
74011188|NCT01431274|147573261|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.107|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.206|0.107|<0.0001
74011189|NCT01431274|147573261|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.142|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.142|<0.0001
74011190|NCT01431274|147573261|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.124|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.074|0.174||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.174|0.074|<0.0001
74011191|NCT01431274|147573261|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.144|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.193|0.094|<0.0001
74011192|NCT01431274|147573261|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.025||0.6103|TWO_SIDED|95.0|-0.037|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.062|-0.037|0.6103
74011193|NCT01431274|147573261|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.087|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.186|0.087|<0.0001
74011194|NCT01431274|147573261|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.049|STANDARD_ERROR_OF_MEAN|0.025||0.0559|TWO_SIDED|95.0|-0.001|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.098|-0.001|0.0559
74011195|NCT01431274|147573261|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.025||0.0073|TWO_SIDED|95.0|0.018|0.118||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.118|0.018|0.0073
74011196|NCT01431274|147573261|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.02|STANDARD_DEVIATION|0.025||0.4368|TWO_SIDED|95.0|-0.07|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.030|-0.070|0.4368
74093653|NCT02944383|147738547|SUPERIORITY|||||||0.4874||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4874
74093654|NCT02944383|147738547|SUPERIORITY|||||||0.9467||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9467
74093655|NCT02944383|147738547|SUPERIORITY|||||||0.7467||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7467
74093656|NCT02944383|147738547|SUPERIORITY||Median Difference (Net)|-0.41||||0.9081|TWO_SIDED|95.0|-10.77|10.75||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||10.75|-10.77|0.9081
74093657|NCT02944383|147738547|SUPERIORITY||Median Difference (Net)|-2.38||||0.548|TWO_SIDED|95.0|-11.82|6.86||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||6.86|-11.82|0.5480
74093658|NCT02944383|147738548|SUPERIORITY|||||||0.1485||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1485
74093659|NCT02944383|147738548|SUPERIORITY|||||||0.6008||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6008
74011197|NCT01431274|147573262|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.147|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.196|0.098|<0.0001
74093660|NCT02944383|147738548|SUPERIORITY|||||||0.9409||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9409
74093661|NCT02944383|147738548|SUPERIORITY|||||||0.9292||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9292
74011198|NCT01431274|147573262|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0023|TWO_SIDED|95.0|0.027|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.027|0.0023
74011199|NCT01431274|147573262|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.170|0.072|<0.0001
74011200|NCT01431274|147573262|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.025||0.0545|TWO_SIDED|95.0|-0.001|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 μg).~Spatial power covariance structure for within-patient errors."|||0.097|-0.001|0.0545
74011201|NCT01431274|147573262|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.025||0.0456|TWO_SIDED|95.0|0.001|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.099|0.001|0.0456
74011202|NCT01431274|147573262|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.025||0.2949|TWO_SIDED|95.0|-0.023|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|-0.023|0.2949
74011203|NCT01431274|147573262|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.074|STANDARD_ERROR_OF_MEAN|0.025||0.0029|TWO_SIDED|95.0|0.025|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.123|0.025|0.0029
74011204|NCT01431274|147573262|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.025||0.0045|TWO_SIDED|95.0|0.022|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.120|0.022|0.0045
74011205|NCT01431274|147573262|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.073|STANDARD_ERROR_OF_MEAN|0.025||0.0035|TWO_SIDED|95.0|0.024|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.122|0.024|0.0035
74011206|NCT01431274|147573262|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.9369|TWO_SIDED|95.0|-0.051|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.051|0.9369
74093662|NCT02944383|147738548|SUPERIORITY|||||||0.8455||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8455
74093663|NCT02944383|147738548|SUPERIORITY|||||||0.5256||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5256
74093664|NCT02944383|147738548|SUPERIORITY|||||||0.9217||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9217
74093665|NCT02944383|147738548|SUPERIORITY|||||||0.7401||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7401
74093666|NCT02944383|147738548|SUPERIORITY|||||||0.9386||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9386
74093667|NCT02944383|147738548|SUPERIORITY|||||||0.6352||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6352
74011207|NCT01431274|147573263|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.168|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.119|0.217||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.217|0.119|<0.0001
74011208|NCT01431274|147573263|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.056|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.154|0.056|<0.0001
74011209|NCT01431274|147573263|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.054|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.152|0.054|<0.0001
74011210|NCT01431274|147573263|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.025||0.0585|TWO_SIDED|95.0|-0.002|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.096|-0.002|0.0585
74011211|NCT01431274|147573263|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.025||0.1042|TWO_SIDED|95.0|-0.008|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.090|-0.008|0.1042
74011212|NCT01431274|147573263|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.025||0.0097|TWO_SIDED|95.0|0.016|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.114|0.016|0.0097
74093668|NCT02944383|147738549|SUPERIORITY|||||||0.0165||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0165
74093669|NCT02944383|147738549|SUPERIORITY|||||||0.3075||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.3075
74093670|NCT02944383|147738549|SUPERIORITY|||||||0.1069||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1069
74093671|NCT02944383|147738549|SUPERIORITY|||||||0.6101||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6101
74011213|NCT01431274|147573263|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.063|0.161||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.161|0.063|<0.0001
74011214|NCT01431274|147573263|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.025||0.012|TWO_SIDED|95.0|0.014|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.112|0.014|0.0120
74011215|NCT01431274|147573263|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.025|TWO_SIDED|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.105|0.007|0.0250
74011216|NCT01431274|147573263|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.025||0.7889|TWO_SIDED|95.0|-0.042|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.056|-0.042|0.7889
74011217|NCT01431274|147573264|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.187|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.138|0.237||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.237|0.138|<0.0001
74011218|NCT01431274|147573264|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.170|0.072|<0.0001
74011219|NCT01431274|147573264|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.103|0.202||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.202|0.103|<0.0001
74011220|NCT01431274|147573264|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.025||0.0134|TWO_SIDED|95.0|0.013|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.111|0.013|0.0134
74011221|NCT01431274|147573264|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.086|STANDARD_ERROR_OF_MEAN|0.025||0.0006|TWO_SIDED|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.136|0.037|0.0006
74011222|NCT01431274|147573264|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.035|STANDARD_ERROR_OF_MEAN|0.025||0.167|TWO_SIDED|95.0|-0.015|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.084|-0.015|0.1670
74011223|NCT01431274|147573264|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.097|STANDARD_ERROR_OF_MEAN|0.025||0.0001|TWO_SIDED|95.0|0.048|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.146|0.048|0.0001
74011224|NCT01431274|147573264|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.025||0.0085|TWO_SIDED|95.0|0.017|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.115|0.017|0.0085
74093672|NCT02944383|147738549|SUPERIORITY||Median Difference (Net)|-12.04||||0.0351|TWO_SIDED|95.0|-23.79|-1.08||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.08|-23.79|0.0351
74011225|NCT01431274|147573264|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.025||0.0003|TWO_SIDED|95.0|0.041|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.140|0.041|0.0003
74011226|NCT01431274|147573264|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.025||0.3332|TWO_SIDED|95.0|-0.074|0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.025|-0.074|0.3332
74011227|NCT01431274|147573265|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.105|0.201||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.201|0.105|<0.0001
74011228|NCT01431274|147573265|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.024||0.0016|TWO_SIDED|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.029|0.0016
74011229|NCT01431274|147573265|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.18||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.180|0.084|<0.0001
74011230|NCT01431274|147573265|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.024||0.0926|TWO_SIDED|95.0|-0.007|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|-0.007|0.0926
74011231|NCT01431274|147573265|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.055|STANDARD_ERROR_OF_MEAN|0.024||0.0231|TWO_SIDED|95.0|0.008|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.103|0.008|0.0231
74011232|NCT01431274|147573265|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.024||0.3802|TWO_SIDED|95.0|-0.026|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.069|-0.026|0.3802
74011233|NCT01431274|147573265|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.024||0.0105|TWO_SIDED|95.0|0.015|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.110|0.015|0.0105
74011234|NCT01431274|147573265|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0018|TWO_SIDED|95.0|0.028|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.125|0.028|0.0018
74011235|NCT01431274|147573265|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.091|STANDARD_ERROR_OF_MEAN|0.025||0.0002|TWO_SIDED|95.0|0.043|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.139|0.043|0.0002
74011236|NCT01431274|147573265|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.024||0.5554|TWO_SIDED|95.0|-0.062|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.034|-0.062|0.5554
74011237|NCT01431274|147573266|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.178|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.127|0.228||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.228|0.127|<0.0001
74011238|NCT01431274|147573266|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.084|STANDARD_ERROR_OF_MEAN|0.026||0.0011|TWO_SIDED|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.134|0.033|0.0011
74011239|NCT01431274|147573266|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.142|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.091|0.192||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.192|0.091|<0.0001
74011240|NCT01431274|147573266|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.026||0.1112|TWO_SIDED|95.0|-0.009|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.091|-0.009|0.1112
74011241|NCT01431274|147573266|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.026||0.0632|TWO_SIDED|95.0|-0.003|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.098|-0.003|0.0632
74011242|NCT01431274|147573266|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.026||0.1615|TWO_SIDED|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.086|-0.014|0.1615
74011243|NCT01431274|147573266|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.026||0.0027|TWO_SIDED|95.0|0.027|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.127|0.027|0.0027
74011244|NCT01431274|147573266|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.044|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.144|0.044|0.0003
74011245|NCT01431274|147573266|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.101|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.05|0.151||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.151|0.050|<0.0001
74011246|NCT01431274|147573266|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.026||0.7925|TWO_SIDED|95.0|-0.057|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.044|-0.057|0.7925
74041810|NCT05109702|147635922|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.294||0.49|TWO_SIDED|95.0|-0.374|0.78|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.780|-0.374|0.490
74011247|NCT01431274|147573267|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.162|0.074|<0.0001
74041811|NCT05109702|147635922|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.297||0.212|TWO_SIDED|95.0|-0.212|0.953|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.953|-0.212|0.212
74041812|NCT05109702|147635923|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.784|TWO_SIDED|95.0|-0.134|0.101|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.101|-0.134|0.784
74011248|NCT01431274|147573267|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.169|0.077|<0.0001
74041813|NCT05109702|147635923|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.324|TWO_SIDED|95.0|-0.058|0.176|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.176|-0.058|0.324
74041814|NCT05109702|147635923|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED|95.0|-0.027|0.21|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.210|-0.027|0.130
74041815|NCT05109702|147635923|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.061||0|TWO_SIDED|95.0|0.11|0.35|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.350|0.110|0.000
74041816|NCT05109702|147635924|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.623||0.532|TWO_SIDED|95.0|-0.834|1.613|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.613|-0.834|0.532
74041817|NCT05109702|147635924|SUPERIORITY||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.63||0.252|TWO_SIDED|95.0|-0.515|1.959|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.959|-0.515|0.252
74041818|NCT05109702|147635924|SUPERIORITY||LS Mean Difference|1.98|STANDARD_ERROR_OF_MEAN|0.636||0.002|TWO_SIDED|95.0|0.732|3.231|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||3.231|0.732|0.002
74041819|NCT05109702|147635925|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.167||0.723|TWO_SIDED|95.0|-0.386|0.268|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.268|-0.386|0.723
74041820|NCT05109702|147635925|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.167||0.254|TWO_SIDED|95.0|-0.519|0.137|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.137|-0.519|0.254
74041821|NCT05109702|147635925|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.169||0.034|TWO_SIDED|95.0|-0.69|-0.028|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||-0.028|-0.690|0.034
74093673|NCT02944383|147738549|SUPERIORITY||Median Difference (Net)|-3.15||||0.3746|TWO_SIDED|95.0|-9.86|4.25||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.25|-9.86|0.3746
74093674|NCT02944383|147738550|SUPERIORITY|||||||0.0133||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0133
74093675|NCT02944383|147738550|SUPERIORITY|||||||0.2044||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2044
74093676|NCT02944383|147738550|SUPERIORITY|||||||0.0855||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0855
74093677|NCT02944383|147738550|SUPERIORITY|||||||0.5114||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5114
74093678|NCT02944383|147738550|SUPERIORITY|||||||0.0289||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0289
74041822|NCT05109702|147635925|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.171||0.64|TWO_SIDED|95.0|-0.255|0.414|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.414|-0.255|0.640
74041823|NCT05109702|147635926|SUPERIORITY|Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.|LS Mean Difference|1.45|STANDARD_DEVIATION|2.893||0.615|TWO_SIDED|95.0|-4.223|7.133|||MMRM|||||7.133|-4.223|0.615
74041824|NCT05109702|147635926|SUPERIORITY||LS Mean Difference|4.81|STANDARD_DEVIATION|2.894||0.097|TWO_SIDED|95.0|-0.866|10.494|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.494|-0.866|0.097
74041825|NCT05109702|147635926|SUPERIORITY||LS Mean Difference|1.06|STANDARD_DEVIATION|2.93||0.718|TWO_SIDED|95.0|-4.69|6.81|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.810|-4.690|0.718
74041826|NCT05109702|147635926|SUPERIORITY||LS Mean Difference|3.09|STANDARD_ERROR_OF_MEAN|2.963||0.298|TWO_SIDED|95.0|-2.728|8.903|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||8.903|-2.728|0.298
74041827|NCT05109702|147635927|SUPERIORITY||LS Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|2.814||0.343|TWO_SIDED|95.0|-2.854|8.191|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.191|-2.854|0.343
74041828|NCT05109702|147635927|SUPERIORITY||LS Mean Difference|3.71|STANDARD_ERROR_OF_MEAN|2.814||0.188|TWO_SIDED|95.0|-1.813|9.232|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||9.232|-1.813|0.188
74093679|NCT02944383|147738550|SUPERIORITY|||||||0.295||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.2950
74041829|NCT05109702|147635927|SUPERIORITY||LS Mean Difference|2.55|STANDARD_ERROR_OF_MEAN|2.849||0.371|TWO_SIDED|95.0|-3.04|8.143|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||8.143|-3.040|0.371
74041830|NCT05109702|147635927|SUPERIORITY||LS Mean Difference|6.92|STANDARD_ERROR_OF_MEAN|2.883||0.017|TWO_SIDED|95.0|1.259|12.573|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||12.573|1.259|0.017
74093680|NCT02944383|147738551|SUPERIORITY|||||||0.1992||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1992
74093681|NCT02944383|147738551|SUPERIORITY|||||||0.9945||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9945
74093682|NCT02944383|147738551|SUPERIORITY|||||||0.5139||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5139
74093683|NCT02944383|147738551|SUPERIORITY|||||||0.8085||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8085
73887986|NCT01746901|147309529|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.0883|TWO_SIDED|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.9|-1.7|0.0883
74041831|NCT05109702|147635928|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|2.7||0.754|TWO_SIDED|95.0|-4.452|6.147|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.147|-4.452|0.754
74041832|NCT05109702|147635928|SUPERIORITY||LS Mean Difference|2.43|STANDARD_ERROR_OF_MEAN|2.7||0.368|TWO_SIDED|95.0|-2.865|7.731|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||7.731|-2.865|0.368
74041833|NCT05109702|147635928|SUPERIORITY||LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|2.734||0.621|TWO_SIDED|95.0|-4.014|6.715|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.715|-4.014|0.621
74041834|NCT05109702|147635928|SUPERIORITY||LS Mean Difference|4.74|STANDARD_ERROR_OF_MEAN|2.766||0.087|TWO_SIDED|95.0|-0.688|10.168|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.168|-0.688|0.087
74041835|NCT05109702|147635929|SUPERIORITY||LS Mean Difference|4.23|STANDARD_ERROR_OF_MEAN|2.646||0.11|TWO_SIDED|95.0|-0.958|9.425|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.425|-0.958|0.110
74041836|NCT05109702|147635929|SUPERIORITY||LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|2.647||0.315|TWO_SIDED|95.0|-2.535|7.855|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.855|-2.535|0.315
74041837|NCT05109702|147635929|SUPERIORITY||LS Mean Difference|2.67|STANDARD_DEVIATION|2.678||0.318|TWO_SIDED|95.0|-2.582|7.928|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.928|-2.582|0.318
74041838|NCT05109702|147635929|SUPERIORITY||LS Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|2.71||0.303|TWO_SIDED|95.0|-2.525|8.111|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.111|-2.525|0.303
74041839|NCT05109702|147635930|SUPERIORITY||LS Mean Difference|4.44|STANDARD_ERROR_OF_MEAN|2.975||0.136|TWO_SIDED|95.0|-1.402|10.273|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||10.273|-1.402|0.136
74041840|NCT05109702|147635930|SUPERIORITY||LS Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|2.972||0.165|TWO_SIDED|95.0|-1.7|9.966|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||9.966|-1.700|0.165
74041841|NCT05109702|147635930|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.008||0.665|TWO_SIDED|95.0|-4.6|7.207|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||7.207|-4.600|0.665
74041842|NCT05109702|147635930|SUPERIORITY||LS Mean Difference|5.02|STANDARD_ERROR_OF_MEAN|3.043||0.099|TWO_SIDED|95.0|-0.95|10.995|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.995|-0.950|0.099
74093684|NCT02944383|147738551|SUPERIORITY||Median Difference (Net)|-0.77||||0.7644|TWO_SIDED|95.0|-6.31|4.85||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.85|-6.31|0.7644
74041843|NCT05109702|147635931|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|2.926||0.861|TWO_SIDED|95.0|-5.232|6.254|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.254|-5.232|0.861
74041844|NCT05109702|147635931|SUPERIORITY||LS Mean Difference|1.76|STANDARD_ERROR_OF_MEAN|2.925||0.548|TWO_SIDED|95.0|-3.983|7.497|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.497|-3.983|0.548
74041845|NCT05109702|147635931|SUPERIORITY||LS Mean Difference|3.97|STANDARD_ERROR_OF_MEAN|2.96||0.18|TWO_SIDED|95.0|-1.839|9.777|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.777|-1.839|0.180
74041846|NCT05109702|147635931|SUPERIORITY||LS Mean Difference|3.93|STANDARD_ERROR_OF_MEAN|2.993||0.189|TWO_SIDED|95.0|-1.941|9.807|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.807|-1.941|0.189
74041847|NCT05109702|147635932|SUPERIORITY||LS Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|2.608||0.613|TWO_SIDED|95.0|-3.799|6.438|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.438|-3.799|0.613
74041848|NCT05109702|147635932|SUPERIORITY||LS Mean Difference|4.53|STANDARD_ERROR_OF_MEAN|2.609||0.083|TWO_SIDED|95.0|-0.586|9.653|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.653|-0.586|0.083
74041849|NCT05109702|147635932|SUPERIORITY||LS Mean Difference|3.67|STANDARD_ERROR_OF_MEAN|2.639||0.165|TWO_SIDED|95.0|-1.508|8.851|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.851|-1.508|0.165
74041850|NCT05109702|147635932|SUPERIORITY||LS Mean Difference|4.28|STANDARD_ERROR_OF_MEAN|2.672||0.11|TWO_SIDED|95.0|-0.964|9.522|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.522|-0.964|0.110
74041851|NCT05109702|147635933|SUPERIORITY||LS Mean Difference|3.57|STANDARD_ERROR_OF_MEAN|1.743||0.041|TWO_SIDED|95.0|0.154|6.994|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.994|0.154|0.041
74041852|NCT05109702|147635933|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.743||0.122|TWO_SIDED|95.0|-0.723|6.118|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.118|-0.723|0.122
74041853|NCT05109702|147635933|SUPERIORITY||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.76||0.009|TWO_SIDED|95.0|1.146|8.056|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.056|1.146|0.009
74041854|NCT05109702|147635933|SUPERIORITY||LS Mean Difference|4.04|STANDARD_ERROR_OF_MEAN|1.781||0.024|TWO_SIDED|95.0|0.544|7.536|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.536|0.544|0.024
74041855|NCT05109702|147635934|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.282|TWO_SIDED|95.0|-0.115|0.394|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.394|-0.115|0.282
74041856|NCT05109702|147635934|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.353|TWO_SIDED|95.0|-0.134|0.375|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.375|-0.134|0.353
74041857|NCT05109702|147635934|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.131||0.764|TWO_SIDED|95.0|-0.297|0.218|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.218|-0.297|0.764
74041858|NCT05109702|147635934|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.133||0.104|TWO_SIDED|95.0|-0.044|0.476|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.476|-0.044|0.104
74041859|NCT05109702|147635935|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15||0.969|TWO_SIDED|95.0|-0.3|0.288|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.288|-0.300|0.969
74041860|NCT05109702|147635935|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.504|TWO_SIDED|95.0|-0.194|0.394|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.394|-0.194|0.504
74041861|NCT05109702|147635935|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.152||0.915|TWO_SIDED|95.0|-0.281|0.314|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.314|-0.281|0.915
74093685|NCT02944383|147738551|SUPERIORITY||Mean Difference (Net)|1.33||||0.9499|TWO_SIDED|95.0|-4.34|6.66||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||6.66|-4.34|0.9499
74093686|NCT02944383|147738552|SUPERIORITY|||||||0.1521||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1521
74093687|NCT02944383|147738552|SUPERIORITY|||||||0.8982||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8982
74093688|NCT02944383|147738552|SUPERIORITY|||||||0.6228||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6228
74093689|NCT02944383|147738552|SUPERIORITY|||||||0.9622||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9622
74093690|NCT02944383|147738552|SUPERIORITY|||||||0.6643||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6643
74093691|NCT02944383|147738552|SUPERIORITY|||||||0.9071||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9071
74093692|NCT02944383|147738553|SUPERIORITY|||||||0.5647||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5647
74093693|NCT02944383|147738553|SUPERIORITY|||||||0.1073||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1073
74093694|NCT02944383|147738553|SUPERIORITY|||||||0.3858||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3858
74093695|NCT02944383|147738553|SUPERIORITY|||||||0.0916||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0916
74093696|NCT02944383|147738553|SUPERIORITY||Median Difference (Net)|0.0||||0.9473|TWO_SIDED|95.0|-5.56|5.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.26|-5.56|0.9473
74093697|NCT02944383|147738553|SUPERIORITY||Median Difference (Net)|4.54||||0.0911|TWO_SIDED|95.0|-1.83|9.95||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||9.95|-1.83|0.0911
74093698|NCT02944383|147738554|SUPERIORITY|||||||0.4623||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4623
74093699|NCT02944383|147738554|SUPERIORITY|||||||0.1678||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1678
74093700|NCT02944383|147738554|SUPERIORITY|||||||0.439||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4390
74093701|NCT02944383|147738554|SUPERIORITY|||||||0.129||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1290
74093702|NCT02944383|147738554|SUPERIORITY|||||||0.9627||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9627
74093703|NCT02944383|147738554|SUPERIORITY|||||||0.0911||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0911
74093704|NCT02944383|147738555|SUPERIORITY|||||||0.2882||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2882
74011249|NCT01431274|147573267|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.022||0.0012|TWO_SIDED|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.114|0.028|0.0012
74011250|NCT01431274|147573267|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.137|0.050|<0.0001
74011251|NCT01431274|147573267|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.023||0.001|TWO_SIDED|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.121|0.031|0.0010
74011252|NCT01431274|147573267|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.023||0.0384|TWO_SIDED|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.092|0.003|0.0384
74011253|NCT01431274|147573267|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.185|0.097|<0.0001
74041862|NCT05109702|147635935|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.153||0.195|TWO_SIDED|95.0|-0.102|0.499|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.499|-0.102|0.195
74041863|NCT05109702|147635936|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.148||0.287|TWO_SIDED|95.0|-0.133|0.449|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.449|-0.133|0.287
74041864|NCT05109702|147635936|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.148||0.26|TWO_SIDED|95.0|-0.124|0.458|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.458|-0.124|0.260
74041865|NCT05109702|147635936|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.987|TWO_SIDED|95.0|-0.296|0.291|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.291|-0.296|0.987
74041866|NCT05109702|147635936|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.151||0.143|TWO_SIDED|95.0|-0.075|0.519|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.519|-0.075|0.143
74041867|NCT05109702|147635937|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.151||-0.198|TWO_SIDED|95.0|-0.102|0.49|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.490|-0.102|-0.198
74041868|NCT05109702|147635937|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.151||0.076|TWO_SIDED|95.0|-0.028|0.564|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.564|-0.028|0.076
74093705|NCT02944383|147738555|SUPERIORITY|||||||0.4474||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4474
74011254|NCT01431274|147573267|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.004|STANDARD_ERROR_OF_MEAN|0.023||0.8428|TWO_SIDED|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.040|-0.049|0.8428
74011255|NCT01431274|147573267|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.022||0.3048|TWO_SIDED|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.020|-0.065|0.3048
74011256|NCT01431274|147573267|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.023||0.4311|TWO_SIDED|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.063|-0.027|0.4311
74011257|NCT01431274|147573268|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.139|0.057|<0.0001
74041869|NCT05109702|147635937|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.152||0.656|TWO_SIDED|95.0|-0.231|0.367|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.367|-0.231|0.656
74041870|NCT05109702|147635937|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.154||0.324|TWO_SIDED|95.0|-0.15|0.454|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.454|-0.150|0.324
74041871|NCT05109702|147635938|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.146||0.477|TWO_SIDED|95.0|-0.182|0.39|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.390|-0.182|0.477
74041872|NCT05109702|147635938|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.146||0.033|TWO_SIDED|95.0|0.026|0.598|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.598|0.026|0.033
74041873|NCT05109702|147635938|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.147||0.374|TWO_SIDED|95.0|-0.158|0.42|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.420|-0.158|0.374
74041874|NCT05109702|147635938|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.149||0.114|TWO_SIDED|95.0|-0.056|0.529|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.529|-0.056|0.114
74041875|NCT05109702|147635939|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.329||0.598|TWO_SIDED|95.0|-0.822|0.475|||t-test, 2 sided|||Immediately Upon Instillation at Week 1||0.475|-0.822|0.598
74041876|NCT05109702|147635939|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.268||0.343|TWO_SIDED|95.0|-0.783|0.273|||t-test, 2 sided|||1 Minute Post Instillation at Week 1||0.273|-0.783|0.343
74041877|NCT05109702|147635939|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.359|TWO_SIDED|95.0|-0.721|0.262|||t-test, 2 sided|||2 Minutes Post Instillation at Week 1||0.262|-0.721|0.359
74041878|NCT03812588|147635940|SUPERIORITY||Slope|7.9|STANDARD_ERROR_OF_MEAN|7.261||0.292|TWO_SIDED|||||Linear regression model of condition in predicting change in HRSD-24. P-value and coefficient are Medication:Track. Medication (Escitalopram or Placebo) with Track (RFM or CFM) as co-variates. The threshold for statistical significance was p\>0.05.|Regression, Linear|||||||0.292
74041879|NCT00180271|147635943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.001|TWO_SIDED|95.0|0.52|0.84||The trial involved prespecified event monitoring at up to 20 successive periods by an independent DSMB to permit trial termination if the CRT-D was superior to, inferior to, or not different from ICD according to prespecified stopping rules.|Log Rank||A Hazard ratio \< 1.0 would indicate that the result favors CRT-D.|The trial utilized a Wang-Tsiatis (delta=0.1) group-sequential design with 95% power to detect a hazard ratio of 0.75 at a two-sided significance level of 0.05. Primary analysis based on statistical evaluation comparing the life-table event-free survival time graphs for CRT-D and ICD-only arms of the trial. Stratified Cox proportional-hazards regression was used to estimate a hazard ratio and statistical significance was evaluated with the log-rank test. Stratified by center and ischemic status.||0.84|0.52|< 0.001
74093706|NCT02944383|147738555|SUPERIORITY|||||||0.7875||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7875
74093707|NCT02944383|147738555|SUPERIORITY|||||||0.06||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0600
74041880|NCT00180271|147635944|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.001|TWO_SIDED|95.0|0.53|0.86|||Andersen-Gill|Andersen-Gill model performed, adjusted for a previous HF event in the study, stratified by ischemic status and using robust variance estimation.|Model adjusted for previously experienced heart failure event in the study. Hazard Ratio (95% CI) comparing patients with a previous heart failure event to those patients without a prior heart failure event equaled 8.84 (6084, 11.43), p\<0.001.|||0.86|0.53|0.001
74041881|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.0856|TWO_SIDED|95.0|0.69|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.69|0.0856
74093708|NCT02944383|147738555|SUPERIORITY||Median Difference (Net)|0.0||||0.9832|TWO_SIDED|95.0|0.0|0.0||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.00|0.00|0.9832
74041882|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.8546|TWO_SIDED|95.0|0.84|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.84|0.8546
74041883|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.73||||0.0012|TWO_SIDED|95.0|0.62|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.62|0.0012
74041884|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.02||||0.8414|TWO_SIDED|95.0|0.87|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.87|0.8414
74041885|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.83||||0.2412|TWO_SIDED|95.0|0.64|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.64|0.2412
74041886|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.4548|TWO_SIDED|95.0|0.88|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.44|0.88|0.4548
74041887|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.69||||0.0093|TWO_SIDED|95.0|0.53|0.88||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.88|0.53|0.0093
74041888|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.8414|TWO_SIDED|95.0|0.86|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.42|0.86|0.8414
74041889|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.1749|TWO_SIDED|95.0|0.75|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.75|0.1749
74041890|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.3121|TWO_SIDED|95.0|0.96|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.27|0.96|0.3121
74041891|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.1351|TWO_SIDED|95.0|0.78|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.78|0.1351
74041892|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.07||||0.8414|TWO_SIDED|95.0|0.93|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.93|0.8414
74041893|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.83||||0.2158|TWO_SIDED|95.0|0.67|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.67|0.2158
74041894|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.3279|TWO_SIDED|95.0|0.71|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.71|0.3279
74093709|NCT02944383|147738555|SUPERIORITY||Median Difference (Net)|0.0||||0.1352|TWO_SIDED|95.0|0.0|0.0||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.00|0.00|0.1352
74093710|NCT02944383|147738556|SUPERIORITY|||||||0.2857||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|ranked ANCOVA|||Week 10||||0.2857
73887987|NCT01746901|147309529|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0241|TWO_SIDED|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.6|2.0|0.0241
74041895|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2472|TWO_SIDED|95.0|0.72|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.72|0.2472
74093711|NCT02944383|147738556|SUPERIORITY|||||||0.4486||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4486
74093712|NCT02944383|147738556|SUPERIORITY|||||||0.764||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7640
74093713|NCT02944383|147738556|SUPERIORITY|||||||0.056||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0560
74041896|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.8414|TWO_SIDED|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.79|0.8414
74041897|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6193|TWO_SIDED|95.0|0.81|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.81|0.6193
74041898|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.3121|TWO_SIDED|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.96|0.3121
74041899|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.0191|TWO_SIDED|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.70|0.0191
74041900|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.14||||0.8414|TWO_SIDED|95.0|0.97|1.33||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.33|0.97|0.8414
74041901|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.76|0.2412
74041902|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.15||||0.3121|TWO_SIDED|95.0|0.99|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.35|0.99|0.3121
74041903|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.8||||0.0135|TWO_SIDED|95.0|0.68|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.94|0.68|0.0135
74093714|NCT02944383|147738556|SUPERIORITY|||||||0.9954||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9954
74093715|NCT02944383|147738556|SUPERIORITY|||||||0.1298||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1298
74093716|NCT02944383|147738557|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 10||||0.0161
74093717|NCT02944383|147738557|SUPERIORITY|||||||0.1806||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 10||||0.1806
74093718|NCT02944383|147738557|SUPERIORITY|||||||0.2657||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 12||||0.2657
74041904|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.8414|TWO_SIDED|95.0|0.87|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.87|0.8414
74041905|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.1749|TWO_SIDED|95.0|0.66|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.66|0.1749
74041906|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.15||||0.3121|TWO_SIDED|95.0|0.93|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.41|0.93|0.3121
74093719|NCT02944383|147738557|SUPERIORITY|||||||0.5996||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 12||||0.5996
74041907|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.7||||0.0038|TWO_SIDED|95.0|0.57|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.57|0.0038
74041908|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.8414|TWO_SIDED|95.0|0.84|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.27|0.84|0.8414
74041909|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.76|0.2412
74093720|NCT02944383|147738557|SUPERIORITY||Median Difference (Net)|-11.39||||0.027|TWO_SIDED|95.0|-28.81|2.08||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||2.08|-28.81|0.0270
74093721|NCT02944383|147738557|SUPERIORITY||Median Difference (Net)|-0.92||||0.5263|TWO_SIDED|95.0|-16.88|15.5||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||15.50|-16.88|0.5263
74093722|NCT02944383|147738558|SUPERIORITY|||||||0.0345||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0345
74093723|NCT02944383|147738558|SUPERIORITY|||||||0.2709||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2709
74093724|NCT02944383|147738558|SUPERIORITY|||||||0.3255||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3255
74093725|NCT02944383|147738558|SUPERIORITY|||||||0.7391||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7391
74093726|NCT02944383|147738558|SUPERIORITY|||||||0.0808||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0808
74093727|NCT02944383|147738558|SUPERIORITY|||||||0.6509||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6509
74093728|NCT02944383|147738559|SUPERIORITY|||||||0.0004||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0004
74093729|NCT02944383|147738559|SUPERIORITY|||||||0.0412||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0412
74093730|NCT02944383|147738559|SUPERIORITY|||||||0.1937||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1937
74041910|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.2||||0.2053|TWO_SIDED|95.0|1.02|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.41|1.02|0.2053
74041911|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.0241|TWO_SIDED|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.70|0.0241
74093731|NCT02944383|147738559|SUPERIORITY|||||||0.474||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4740
74093732|NCT02944383|147738559|SUPERIORITY||Median Difference (Net)|-14.32||||0.0116|TWO_SIDED|95.0|-34.13|3.89||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||3.89|-34.13|0.0116
74093733|NCT02944383|147738559|SUPERIORITY||Median Difference (Net)|-3.66||||0.1109|TWO_SIDED|95.0|-23.85|14.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||14.26|-23.85|0.1109
74041912|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.8414|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.8414
74093734|NCT02944383|147738560|SUPERIORITY|||||||0.0002||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0002
74093735|NCT02944383|147738560|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0161
74093736|NCT02944383|147738560|SUPERIORITY|||||||0.3043||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3043
74093737|NCT02944383|147738560|SUPERIORITY|||||||0.4639||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4639
74041913|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.0732|TWO_SIDED|95.0|0.69|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.94|0.69|0.0732
74093738|NCT02944383|147738560|SUPERIORITY|||||||0.021||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0210
74093739|NCT02944383|147738560|SUPERIORITY|||||||0.0992||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0992
74041914|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.609|TWO_SIDED|95.0|0.82|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.82|0.6090
74093740|NCT02944383|147738561|SUPERIORITY|||||||0.1512||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1512
74093741|NCT02944383|147738561|SUPERIORITY|||||||0.84||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8400
74093742|NCT02944383|147738561|SUPERIORITY|||||||0.0244||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0244
74093743|NCT02944383|147738561|SUPERIORITY|||||||0.1803||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1803
74093744|NCT02944383|147738561|SUPERIORITY||Median Difference (Net)|-24.41||||0.0307|TWO_SIDED|95.0|-42.73|-9.94||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-9.94|-42.73|0.0307
73879605|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.95||0.0006|TWO_SIDED|95.0|-10.6|-2.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.94|-10.60|0.0006
74093745|NCT02944383|147738561|SUPERIORITY||Median Difference (Net)|-8.73||||0.5326|TWO_SIDED|95.0|-23.33|7.68||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.68|-23.33|0.5326
74093746|NCT02944383|147738562|SUPERIORITY|||||||0.1705||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1705
74011258|NCT01431274|147573268|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.149|0.063|<0.0001
74011259|NCT01431274|147573268|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.021||0.0136|TWO_SIDED|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.091|0.010|0.0136
74011260|NCT01431274|147573268|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.021||0.0003|TWO_SIDED|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.116|0.035|0.0003
74011261|NCT01431274|147573268|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.0065|TWO_SIDED|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.101|0.016|0.0065
74011262|NCT01431274|147573268|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0277|TWO_SIDED|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.089|0.005|0.0277
74011263|NCT01431274|147573268|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.164|0.081|<0.0001
74011264|NCT01431274|147573268|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.7116|TWO_SIDED|95.0|-0.049|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.034|-0.049|0.7116
74011265|NCT01431274|147573268|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.02||0.2332|TWO_SIDED|95.0|-0.065|0.016||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.016|-0.065|0.2332
74011266|NCT01431274|147573268|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.021||0.4374|TWO_SIDED|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.059|-0.025|0.4374
74011267|NCT01431274|147573269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.161|STANDARD_ERROR_OF_MEAN|0.043||0.0002|TWO_SIDED|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.244|0.077|0.0002
74011268|NCT01431274|147573269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.045||0.0017|TWO_SIDED|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.228|0.053|0.0017
74011269|NCT01431274|147573269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.042||0.0022|TWO_SIDED|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.210|0.046|0.0022
74011270|NCT01431274|147573269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.176|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.259|0.093|<0.0001
73879606|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.93||0.002|TWO_SIDED|95.0|-9.82|-2.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.21|-9.82|0.0020
74011271|NCT01431274|147573269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.044||0.0141|TWO_SIDED|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.194|0.022|0.0141
74011272|NCT01431274|147573269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.043||0.4581|TWO_SIDED|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.118|-0.053|0.4581
74011273|NCT01431274|147573269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.293|0.124|<0.0001
74011274|NCT01431274|147573269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.043||0.6335|TWO_SIDED|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.105|-0.064|0.6335
74011275|NCT01431274|147573269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.047|STANDARD_ERROR_OF_MEAN|0.041||0.253|TWO_SIDED|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.034|-0.129|0.2530
74011276|NCT01431274|147573269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.043||0.1188|TWO_SIDED|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.153|-0.017|0.1188
74011277|NCT01431274|147573270|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.041||0.0008|TWO_SIDED|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.217|0.057|0.0008
74011278|NCT01431274|147573270|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.043||0.0032|TWO_SIDED|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.209|0.042|0.0032
74011279|NCT01431274|147573270|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.04||0.0085|TWO_SIDED|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.183|0.027|0.0085
74011280|NCT01431274|147573270|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.04||0.0001|TWO_SIDED|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.235|0.077|0.0001
74011281|NCT01431274|147573270|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0255|TWO_SIDED|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.176|0.011|0.0255
74011282|NCT01431274|147573270|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.041||0.4393|TWO_SIDED|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.113|-0.049|0.4393
74011283|NCT01431274|147573270|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.188|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.269|0.108|<0.0001
74011284|NCT01431274|147573270|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.041||0.7784|TWO_SIDED|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.092|-0.069|0.7784
74011285|NCT01431274|147573270|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.039||0.1965|TWO_SIDED|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.026|-0.129|0.1965
74011286|NCT01431274|147573270|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.041||0.1315|TWO_SIDED|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.144|-0.019|0.1315
74011287|NCT01431274|147573271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.141|STANDARD_ERROR_OF_MEAN|0.56||0.0001|TWO_SIDED|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-1.043|-3.239|0.0001
74011288|NCT01431274|147573271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.131|STANDARD_ERROR_OF_MEAN|0.56||0.0435|TWO_SIDED|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||-0.033|-2.230|0.0435
74011289|NCT01431274|147573271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.528|STANDARD_ERROR_OF_MEAN|0.559||0.0063|TWO_SIDED|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.432|-2.623|0.0063
74011290|NCT01431274|147573271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.517|STANDARD_ERROR_OF_MEAN|0.558||0.3545|TWO_SIDED|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.577|-1.611|0.3545
74011291|NCT01431274|147573271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.518|STANDARD_ERROR_OF_MEAN|0.559||0.3542|TWO_SIDED|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.578|-1.614|0.3542
74011292|NCT01431274|147573271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.613|STANDARD_ERROR_OF_MEAN|0.556||0.2697|TWO_SIDED|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.476|-1.702|0.2697
74041915|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.65|||<|0.0001|TWO_SIDED|95.0|0.56|0.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.76|0.56|<0.0001
74041916|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.8414|TWO_SIDED|95.0|0.82|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.82|0.8414
74041917|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.7828|TWO_SIDED|95.0|0.82|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.82|0.7828
74041918|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.21||||0.2053|TWO_SIDED|95.0|1.02|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|1.02|0.2053
74041919|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.77||||0.0093|TWO_SIDED|95.0|0.65|0.92||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.92|0.65|0.0093
74041920|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.8414|TWO_SIDED|95.0|0.93|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.93|0.8414
74041921|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2412|TWO_SIDED|95.0|0.73|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.73|0.2412
74041922|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.14||||0.3121|TWO_SIDED|95.0|0.95|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.95|0.3121
74041923|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.77||||0.0135|TWO_SIDED|95.0|0.64|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.93|0.64|0.0135
74041924|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.8414|TWO_SIDED|95.0|0.92|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.34|0.92|0.8414
74041925|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.79|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.79|0.2412
74041926|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.6652|TWO_SIDED|95.0|0.91|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.91|0.6652
74093747|NCT02944383|147738562|SUPERIORITY|||||||0.9193||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9193
74093748|NCT02944383|147738562|SUPERIORITY|||||||0.0224||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0224
73879607|NCT03192176|147297614|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.93||0.0588|TWO_SIDED|95.0|-7.46|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.14|-7.46|0.0588
74093749|NCT02944383|147738562|SUPERIORITY|||||||0.2387||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2387
74093750|NCT02944383|147738562|SUPERIORITY|||||||0.06||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0600
74093751|NCT02944383|147738562|SUPERIORITY|||||||0.6878||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6878
74093752|NCT02944383|147738563|SUPERIORITY|||||||0.0298||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0298
74093753|NCT02944383|147738563|SUPERIORITY|||||||0.0196||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0196
74093754|NCT02944383|147738563|SUPERIORITY|||||||0.2219||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2219
74093755|NCT02944383|147738563|SUPERIORITY|||||||0.4078||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4078
74041927|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.0275|TWO_SIDED|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.75|0.0275
74041928|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.8414|TWO_SIDED|95.0|0.93|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.93|0.8414
74041929|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.76|0.2412
74041930|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.3121|TWO_SIDED|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.96|0.3121
74041931|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.0387|TWO_SIDED|95.0|0.72|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.99|0.72|0.0387
74041932|NCT01392378|147635953|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.8414|TWO_SIDED|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.89|0.8414
74041933|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.935|TWO_SIDED|95.0|0.82|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.82|0.9350
74041934|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.7918|TWO_SIDED|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.93|0.7918
74041935|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.6922|TWO_SIDED|95.0|0.8|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.80|0.6922
74093756|NCT02944383|147738563|SUPERIORITY||Median Difference (Net)|-15.34||||0.0605|TWO_SIDED|95.0|-31.68|1.3||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||1.30|-31.68|0.0605
74093757|NCT02944383|147738563|SUPERIORITY||Median Difference (Net)|-4.08||||0.1768|TWO_SIDED|95.0|-19.91|7.32||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.32|-19.91|0.1768
74093758|NCT02944383|147738564|SUPERIORITY|||||||0.0084||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0084
74041936|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.9765|TWO_SIDED|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.93|0.9765
74041937|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6915|TWO_SIDED|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.78|0.6915
74041938|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.7918|TWO_SIDED|95.0|0.94|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.36|0.94|0.7918
74093759|NCT02944383|147738564|SUPERIORITY|||||||0.0047||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0047
74093760|NCT02944383|147738564|SUPERIORITY|||||||0.1574||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1574
74011293|NCT01431274|147573271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.559||0.0434|TWO_SIDED|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||-0.033|-2.227|0.0434
74011294|NCT01431274|147573271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.563||0.0732|TWO_SIDED|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.095|-2.114|0.0732
74011295|NCT01431274|147573271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.011|STANDARD_ERROR_OF_MEAN|0.563||0.0724|TWO_SIDED|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.092|-2.114|0.0724
74011296|NCT01431274|147573271|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.563||0.9983|TWO_SIDED|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.104|-1.102|0.9983
74011297|NCT01431274|147573272|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.852|STANDARD_ERROR_OF_MEAN|0.578||0.0014|TWO_SIDED|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.718|-2.985|0.0014
74011298|NCT01431274|147573272|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.444|STANDARD_ERROR_OF_MEAN|0.576||0.4413|TWO_SIDED|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.686|-1.573|0.4413
74011299|NCT01431274|147573272|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.437|STANDARD_ERROR_OF_MEAN|0.578||0.0129|TWO_SIDED|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.304|-2.569|0.0129
74011300|NCT01431274|147573272|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.574||0.9222|TWO_SIDED|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.070|-1.182|0.9222
74011301|NCT01431274|147573272|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.029|STANDARD_ERROR_OF_MEAN|0.576||0.9602|TWO_SIDED|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|ANCOVA|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||1.100|-1.157|0.9602
74041939|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.4389|TWO_SIDED|95.0|0.75|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.75|0.4389
74041940|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.85|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.85|0.9765
74011302|NCT01431274|147573272|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.415|STANDARD_ERROR_OF_MEAN|0.57||0.4669|TWO_SIDED|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.703|-1.533|0.4669
74093761|NCT02944383|147738564|SUPERIORITY|||||||0.3235||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3235
74011303|NCT01431274|147573272|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.471|STANDARD_ERROR_OF_MEAN|0.575||0.4126|TWO_SIDED|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.656|-1.598|0.4126
74011304|NCT01431274|147573272|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.408|STANDARD_ERROR_OF_MEAN|0.583||0.0158|TWO_SIDED|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.265|-2.551|0.0158
74093762|NCT02944383|147738564|SUPERIORITY|||||||0.0367||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0367
74093763|NCT02944383|147738564|SUPERIORITY|||||||0.0948||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0948
74093764|NCT02944383|147738565|SUPERIORITY|||||||0.0037||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0037
74093765|NCT02944383|147738565|SUPERIORITY|||||||0.1328||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1328
74093766|NCT02944383|147738565|SUPERIORITY|||||||0.4364||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4364
74093767|NCT02944383|147738565|SUPERIORITY|||||||0.8129||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8129
74093768|NCT02944383|147738565|SUPERIORITY||Median Difference (Net)|-15.29||||0.0347|TWO_SIDED|95.0|-36.54|2.35||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||2.35|-36.54|0.0347
74093769|NCT02944383|147738565|SUPERIORITY||Median Difference (Net)|-2.14||||0.3617|TWO_SIDED|95.0|-25.78|23.62||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||23.62|-25.78|0.3617
74093770|NCT02944383|147738566|SUPERIORITY|||||||0.0085||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0085
74093771|NCT02944383|147738566|SUPERIORITY|||||||0.2112||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2112
74093772|NCT02944383|147738566|SUPERIORITY|||||||0.7301||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7301
74093773|NCT02944383|147738566|SUPERIORITY|||||||0.6283||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6283
74093774|NCT02944383|147738566|SUPERIORITY|||||||0.0919||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0919
74011305|NCT01431274|147573272|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.381|STANDARD_ERROR_OF_MEAN|0.582||0.0177|TWO_SIDED|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.240|-2.521|0.0177
74011306|NCT01431274|147573272|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.027|STANDARD_ERROR_OF_MEAN|0.58||0.9624|TWO_SIDED|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.109|-1.164|0.9624
74093775|NCT02944383|147738566|SUPERIORITY|||||||0.5497||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.5497
74093776|NCT02944383|147738567|SUPERIORITY|||||||0.0009||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0009
74093777|NCT02944383|147738567|SUPERIORITY|||||||0.0351||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0351
74093778|NCT02944383|147738567|SUPERIORITY|||||||0.1561||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1561
74093779|NCT02944383|147738567|SUPERIORITY|||||||0.0268||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0268
74093780|NCT02944383|147738567|SUPERIORITY||Median Difference (Net)|-22.3||||0.0516|TWO_SIDED|95.0|-42.96|-1.67||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.67|-42.96|0.0516
74093781|NCT02944383|147738567|SUPERIORITY||Median Difference (Net)|-13.06||||0.0125|TWO_SIDED|95.0|-32.83|4.88||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.88|-32.83|0.0125
74093782|NCT02944383|147738568|SUPERIORITY|||||||0.0023||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0023
74093783|NCT02944383|147738568|SUPERIORITY|||||||0.0356||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0356
74093784|NCT02944383|147738568|SUPERIORITY|||||||0.2284||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2284
74093785|NCT02944383|147738568|SUPERIORITY|||||||0.0213||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0213
74093786|NCT02944383|147738568|SUPERIORITY|||||||0.033||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0330
74093787|NCT02944383|147738568|SUPERIORITY|||||||0.0221||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0221
74093788|NCT02944383|147738569|SUPERIORITY||Median Difference (Net)|-2.67||||0.2632|TWO_SIDED|95.0|-10.17|5.67||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL||5.67|-10.17|0.2632
74093789|NCT02944383|147738569|SUPERIORITY||Median Difference (Net)|2.02||||0.5382|TWO_SIDED|95.0|-6.77|9.71||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL||9.71|-6.77|0.5382
74093790|NCT02944383|147738569|SUPERIORITY||Median Difference (Net)|0.0||||0.1727|TWO_SIDED|95.0|-0.51|1.01||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL||1.01|-0.51|0.1727
74093791|NCT02944383|147738569|SUPERIORITY||Median Difference (Net)|0.0||||0.4567|TWO_SIDED|95.0|-0.51|0.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL||0.51|-0.51|0.4567
74093792|NCT02944383|147738569|SUPERIORITY||Median Difference (Net)|0.0||||0.6142|TWO_SIDED|95.0|-1.21|1.47||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|HDL||1.47|-1.21|0.6142
73879608|NCT03192176|147297614|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.93||0.0018|TWO_SIDED|95.0|-9.9|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.14|-9.90|0.0018
73879609|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.94||0.0017|TWO_SIDED|95.0|-9.98|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.34|-9.98|0.0017
74011307|NCT01431274|147573273|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.595|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.862|0.329|<0.0001
74011308|NCT01431274|147573273|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.907|0.373|<0.0001
74011309|NCT01431274|147573273|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.423|STANDARD_ERROR_OF_MEAN|0.136||0.0019|TWO_SIDED|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.690|0.156|0.0019
74011310|NCT01431274|147573273|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.446|STANDARD_ERROR_OF_MEAN|0.136||0.0011|TWO_SIDED|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.712|0.179|0.0011
74011311|NCT01431274|147573273|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.468|STANDARD_ERROR_OF_MEAN|0.136||0.0006|TWO_SIDED|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.735|0.201|0.0006
74041941|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.935|TWO_SIDED|95.0|0.87|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.87|0.9350
74041942|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.7918|TWO_SIDED|95.0|0.9|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.90|0.7918
74041943|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.943|TWO_SIDED|95.0|0.88|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.88|0.9430
74093793|NCT02944383|147738569|SUPERIORITY||Median Difference (Net)|-0.02||||0.2409|TWO_SIDED|95.0|-2.23|1.29||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|HDL||1.29|-2.23|0.2409
74093794|NCT02944383|147738570|SUPERIORITY|||||||0.2721||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL||||0.2721
73879610|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.97||0.0003|TWO_SIDED|95.0|-11.09|-3.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-3.32|-11.09|0.0003
74093795|NCT02944383|147738570|SUPERIORITY|||||||0.5669||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL||||0.5669
74093796|NCT02944383|147738570|SUPERIORITY|||||||0.1686||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL||||0.1686
74093797|NCT02944383|147738570|SUPERIORITY|||||||0.4308||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL||||0.4308
74093798|NCT02944383|147738570|SUPERIORITY|||||||0.5495||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||HDL||||0.5495
73879611|NCT03192176|147297614|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.97||0.081|TWO_SIDED|95.0|-8.55|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.81|-8.55|0.0810
74011312|NCT01431274|147573273|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.172|STANDARD_ERROR_OF_MEAN|0.136||0.2045|TWO_SIDED|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.438|-0.094|0.2045
74011313|NCT01431274|147573273|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.618|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.885|0.351|<0.0001
74011314|NCT01431274|147573273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.045|STANDARD_ERROR_OF_MEAN|0.137||0.7432|TWO_SIDED|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.223|-0.313|0.7432
74011315|NCT01431274|147573273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.136||0.8687|TWO_SIDED|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.245|-0.290|0.8687
74011316|NCT01431274|147573273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.137||0.8709|TWO_SIDED|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.246|-0.290|0.8709
74011317|NCT01431274|147573274|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.63|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.898|0.362|<0.0001
74093799|NCT02944383|147738570|SUPERIORITY|||||||0.2384||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||HDL||||0.2384
74093800|NCT02944383|147738571|SUPERIORITY||Median Difference (Net)|-13.99||||0.0781|TWO_SIDED|95.0|-33.76|2.55||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL \& Chylomicron particles||2.55|-33.76|0.0781
74093801|NCT02944383|147738571|SUPERIORITY||Median Difference (Net)|-2.1||||0.9901|TWO_SIDED|95.0|-19.36|19.01||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL \& Chylomicron particles||19.01|-19.36|0.9901
73887988|NCT01746901|147309529|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0235|TWO_SIDED|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.6|2.0|0.0235
74011318|NCT01431274|147573274|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.434|STANDARD_ERROR_OF_MEAN|0.137||0.0015|TWO_SIDED|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.703|0.166|0.0015
74011319|NCT01431274|147573274|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.419|STANDARD_ERROR_OF_MEAN|0.137||0.0022|TWO_SIDED|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.687|0.151|0.0022
74011320|NCT01431274|147573274|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.227|STANDARD_ERROR_OF_MEAN|0.137||0.0966|TWO_SIDED|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.495|-0.041|0.0966
74011321|NCT01431274|147573274|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.223|STANDARD_ERROR_OF_MEAN|0.137||0.1029|TWO_SIDED|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.492|-0.045|0.1029
74011322|NCT01431274|147573274|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.211|STANDARD_ERROR_OF_MEAN|0.136||0.122|TWO_SIDED|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.478|-0.056|0.1220
74011323|NCT01431274|147573274|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.438|STANDARD_ERROR_OF_MEAN|0.137||0.0014|TWO_SIDED|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.707|0.170|0.0014
74011324|NCT01431274|147573274|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.196|STANDARD_ERROR_OF_MEAN|0.137||0.1542|TWO_SIDED|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.465|-0.074|0.1542
74011325|NCT01431274|147573274|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.137||0.1626|TWO_SIDED|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.461|-0.077|0.1626
74011326|NCT01431274|147573274|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.138||0.9765|TWO_SIDED|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.274|-0.265|0.9765
74041944|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.9765|TWO_SIDED|95.0|0.85|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.85|0.9765
74011327|NCT01431274|147573275|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.647|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.925|0.370|<0.0001
74041945|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.5167|TWO_SIDED|95.0|0.74|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.74|0.5167
74041946|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.7918|TWO_SIDED|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.78|0.7918
74041947|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.2514|TWO_SIDED|95.0|0.73|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.73|0.2514
74011328|NCT01431274|147573275|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.322|STANDARD_ERROR_OF_MEAN|0.141||0.0226|TWO_SIDED|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.600|0.045|0.0226
74011329|NCT01431274|147573275|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.371|STANDARD_ERROR_OF_MEAN|0.142||0.0089|TWO_SIDED|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.649|0.093|0.0089
74011330|NCT01431274|147573275|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.332|STANDARD_ERROR_OF_MEAN|0.141||0.0186|TWO_SIDED|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.609|0.056|0.0186
74011331|NCT01431274|147573275|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.142||0.7441|TWO_SIDED|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.324|-0.231|0.7441
74011332|NCT01431274|147573275|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.276|STANDARD_ERROR_OF_MEAN|0.14||0.0492|TWO_SIDED|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 μg).~Spatial power covariance structure for within-patient errors."|||0.551|0.001|0.0492
74011333|NCT01431274|147573275|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.608|STANDARD_ERROR_OF_MEAN|0.141|<|0.0001|TWO_SIDED|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.884|0.332|<0.0001
74011334|NCT01431274|147573275|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.325|STANDARD_ERROR_OF_MEAN|0.143||0.023|TWO_SIDED|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within-patient errors."|||0.605|0.045|0.0230
74011335|NCT01431274|147573275|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.142||0.7855|TWO_SIDED|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.317|-0.240|0.7855
74011336|NCT01431274|147573275|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.142||0.0442|TWO_SIDED|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.564|0.007|0.0442
74011337|NCT01748942|147573321|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
74011338|NCT01748942|147573324|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
74011339|NCT01748942|147573325|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
74011340|NCT01748942|147573326|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
74011341|NCT01748942|147573327|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
74011342|NCT01748942|147573328|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
74011343|NCT04037748|147573329|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|90.8|||||TWO_SIDED|90.0|86.3|95.6||||||||95.6|86.3|
74011344|NCT04037748|147573330|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|93.7|||||TWO_SIDED|90.0|88.2|99.5||||||||99.5|88.2|
74011345|NCT04037748|147573332|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|97.3|||||TWO_SIDED|90.0|94.7|100.0||||||||100.0|94.7|
74011346|NCT04037748|147573333|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|94.82|||||TWO_SIDED|90.0|92.0|97.8||||||||97.8|92.0|
74011347|NCT00487396|147573456|OTHER||||||<|0.0001|||||||McNemar|||"Pathologies were including in the analysis as follows:~* combination of CE+IC procedures but not detected by the combination of SBFT+IC procedures were marked as CE+IC new finding ;~* Pathologies detected by the combination of SBFT+IC procedures but not detected by the combination of CE+IC procedures were marked as SBFT+IC new finding event;~* Pathologies detected by the combination of CE+IC procedures and by the combination of SBFT+IC procedures were marked as same findings event."||||<0.0001
74011348|NCT00487396|147573457|OTHER||||||<|0.0001|||||||McNemar|||"For each category, the numbers of found and missed pathologies were including in the analysis as follows:~* Pathologies detected by CE procedure but not detected by SBFT procedure were marked as CE new finding event;~* Pathologies detected by SBFT procedure but not detected by CE procedure were marked as SBFT new finding event;~* Pathologies detected by both procedures (i.e., CE and SBFT) were marked as same findings event."||||<0.0001
74041948|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.9872|TWO_SIDED|95.0|0.84|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.84|0.9872
74011349|NCT00487396|147573458|OTHER|||||||0.085|||||||McNemar|||"Pathologies were including in the analysis as follows:~* Pathologies detected by CE procedure but not detected by IC procedure were marked as CE new finding event;~* Pathologies detected by IC procedure but not detected by CE procedure were marked as IC new finding event;~* Pathologies detected by both procedures (i.e., CE and IC) were marked as same findings event."||||0.085
74011350|NCT01484977|147573460|SUPERIORITY_OR_OTHER||Retention Rate|73.3|||||TWO_SIDED|95.0|65.42|81.25||||||"Analyses of the primary efficacy variable will be descriptive only. No hypothesis tests are planned.~The number and percentage of subjects remaining in the study through the 21-Week Treatment Period will be calculated. Subjects with retention will be counted in the numerator. All subjects in the relevant population will be used as the denominator.~This percentage will be known as the retention rate, along with the 95 % confidence interval based on the normal approximation."||81.25|65.42|
74011351|NCT01538628|147573464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Exact binomial test|testing the null hypothesis that the proportion for SpaceOAR is less than or equal to 0.70.||||||.0001
74011352|NCT01648790|147573476|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.983|||||TWO_SIDED|90.0|0.819|1.18|||||Least Squares (LS) means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||1.18|0.819|
74011353|NCT01648790|147573477|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.987|||||TWO_SIDED|90.0|0.918|1.06|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||1.06|0.918|
74011354|NCT01648790|147573478|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.28|||||TWO_SIDED|90.0|0.233|0.335|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||0.335|0.233|
74011355|NCT01648790|147573479|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.779|||||TWO_SIDED|90.0|0.724|0.837|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||0.837|0.724|
74011356|NCT01486927|147573494|SUPERIORITY_OR_OTHER||Rate ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.07|0.1|||Poisson, regression|||A test of the null hypothesis of no difference on AsBR between the 2 comparison groups was based on the Poisson Regression method. The corresponding prophylaxis/on-demand ratio with 95% confidence interval (CI) was calculated.||0.10|0.07|< 0.0001
74011357|NCT01476475|147573515|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of insulin glargine/lixisenatide FRC versus insulin glargine was tested first, at alpha level of 0.025 (1-sided) and a non-inferiority margin of 0.4% HbA1c. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided). The non-inferiority was assessed using upper bound of 2-sided 95% confidence interval (CI) at ≤0.4%.|Least square (LS) mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.312|-0.037|||ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline HbA1c value as covariates. A step-down testing procedure described by Hochberg and Tamhane was used to control type-1 error.||-0.037|-0.312|
74011358|NCT01476475|147573515|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.312|-0.037||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline HbA1c value as covariates. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided).||-0.037|-0.312|0.0130
74041949|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2582|TWO_SIDED|95.0|0.73|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.73|0.2582
74011359|NCT01476475|147573516|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.17|STANDARD_ERROR_OF_MEAN|0.337|<|0.0001|TWO_SIDED|95.0|-3.832|-2.504||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA with treatment groups,randomization strata of screening HbA1c(\<8.0, ≥8.0%)\& screening BMI(\<30 kg/m\^2, ≥30 kg/m\^2),country as fixed effects and baseline 2-hour PPG value as covariates.A step-down testing procedure used to control type-1 error.If non-inferiority demonstrated for primary endpoint,superiority testing on secondary endpoints was performed sequentially in order endpoints are reported(continued only if previous endpoint was statistically significant).||-2.504|-3.832|<0.0001
74011360|NCT01476475|147573517|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|0.331|<|0.0001|TWO_SIDED|95.0|-3.895|-2.592||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline 2-hour plasma glucose excursion value as covariates.||-2.592|-3.895|<0.0001
74041950|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.7918|TWO_SIDED|95.0|0.91|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.91|0.7918
74041951|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.2514|TWO_SIDED|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.74|0.2514
74041952|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.88|0.9765
74041953|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.6915|TWO_SIDED|95.0|0.86|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.86|0.6915
74041954|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.7918|TWO_SIDED|95.0|0.93|1.38||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.38|0.93|0.7918
74041955|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.78|0.6922
74041956|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.01||||0.9872|TWO_SIDED|95.0|0.83|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.83|0.9872
74041957|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.3609|TWO_SIDED|95.0|0.7|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.70|0.3609
74041958|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.08||||0.7918|TWO_SIDED|95.0|0.89|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.89|0.7918
74041959|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.2514|TWO_SIDED|95.0|0.71|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.71|0.2514
74041960|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.9765|TWO_SIDED|95.0|0.86|1.26||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.26|0.86|0.9765
74041961|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.6304|TWO_SIDED|95.0|0.79|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.79|0.6304
74041962|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.7918|TWO_SIDED|95.0|0.91|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.91|0.7918
74041963|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2514|TWO_SIDED|95.0|0.75|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.75|0.2514
74093802|NCT02944383|147738571|SUPERIORITY||Median Difference (Net)|-25.23||||0.0717|TWO_SIDED|95.0|-43.62|-5.1||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL Particles||-5.10|-43.62|0.0717
74093803|NCT02944383|147738571|SUPERIORITY||Median Difference (Net)|-16.09||||0.1548|TWO_SIDED|95.0|-36.78|3.76||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL Particles||3.76|-36.78|0.1548
74041964|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.88|0.9765
74041965|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.2582|TWO_SIDED|95.0|0.71|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.71|0.2582
74041966|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.9279|TWO_SIDED|95.0|0.84|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.84|0.9279
74041967|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2514|TWO_SIDED|95.0|0.72|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.72|0.2514
74041968|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.9765|TWO_SIDED|95.0|0.76|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.76|0.9765
74041969|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.1424|TWO_SIDED|95.0|0.71|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.71|0.1424
74041970|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.7918|TWO_SIDED|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.84|0.7918
74041971|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2514|TWO_SIDED|95.0|0.73|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.73|0.2514
74041972|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.9765|TWO_SIDED|95.0|0.79|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.79|0.9765
74041973|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.6304|TWO_SIDED|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.78|0.6304
74041974|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.7918|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.7918
74093804|NCT02944383|147738571|SUPERIORITY||Median Difference (Net)|-47.16||||0.0428|TWO_SIDED|95.0|-119.58|-5.78||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|IDL Particles||-5.78|-119.58|0.0428
74093805|NCT02944383|147738571|SUPERIORITY||Median Difference (Net)|-26.13||||0.1836|TWO_SIDED|95.0|-121.44|19.48||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|IDL Particles||19.48|-121.44|0.1836
74093806|NCT02944383|147738572|SUPERIORITY|||||||0.1251||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL \& Chylomicron Particles||||0.1251
74093807|NCT02944383|147738572|SUPERIORITY|||||||0.9047||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL \& Chylomicron Particles||||0.9047
74093808|NCT02944383|147738572|SUPERIORITY|||||||0.0788||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL Particles||||0.0788
74093809|NCT02944383|147738572|SUPERIORITY|||||||0.1222||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL Particles||||0.1222
74093810|NCT02944383|147738572|SUPERIORITY|||||||0.0734||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||IDL Particles||||0.0734
74011361|NCT01476475|147573518|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.125||0.0154|TWO_SIDED|95.0|-0.55|-0.058||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline average 7-point SMPG value as covariates.||-0.058|-0.550|0.0154
74011362|NCT01476475|147573519|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.11|-0.773||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline body weight value as covariates.||-0.773|-2.110|<0.0001
74011363|NCT01476475|147573520|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.704||0.0583|TWO_SIDED|95.0|-6.592|0.114||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects.||0.114|-6.592|0.0583
74011364|NCT01278745|147573529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||ANCOVA|Adjusted for baseline PAV||||||0.0019
74011365|NCT01843842|147573542|SUPERIORITY|||||||0.016|||||||Global Test Statistic|See O'Brien 1984, Pocock 1997.||||||0.016
74011366|NCT01843842|147573543|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74011367|NCT01843842|147573544|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
74011368|NCT01843842|147573545|SUPERIORITY|||||||0.0283||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Day 3, doctor's examination)||||0.0283
74011369|NCT01843842|147573545|SUPERIORITY|||||||0.3264|||||||Kruskal-Wallis|||Non-specific (Day 3, doctor's examination)||||0.3264
74011370|NCT01843842|147573545|SUPERIORITY|||||||0.706|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Day 3, doctor's examination)||||0.7060
74011371|NCT01843842|147573545|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||All symptoms (Day 3, doctor's examination)||||0.25
74011372|NCT01843842|147573545|SUPERIORITY|||||||0.244|||||||ANCOVA|||Severity of clinical manifestations of acute respiratory infection (ARI) by Total Symptom Score on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)||||0.244
74011373|NCT01843842|147573546|SUPERIORITY|||||||0.1158|||||||Kruskal-Wallis|||Duration of fever based on Patient Diary Data||||0.1158
74011374|NCT01843842|147573546|SUPERIORITY|||||||0.5755|||||||Kruskal-Wallis|||Duration of non-specific symptoms based on Patient Diary Data||||0.5755
74011375|NCT01843842|147573546|SUPERIORITY|||||||0.4331|||||||Kruskal-Wallis|||Duration of nasal/ throat/ chest symptoms based on Patient Diary Data||||0.4331
74011376|NCT01843842|147573546|SUPERIORITY|||||||0.356|||||||Kruskal-Wallis|||Duration of all acute respiratory infection symptoms (fever, non-specific symptoms and nasal/ throat/ chest symptoms) based on Patient Diary Data||||0.3560
74011377|NCT01843842|147573547|SUPERIORITY|||||||0.0166||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1, 3, 6 doctor's examination)||||0.0166
74011378|NCT01843842|147573547|SUPERIORITY|||||||0.082|||||||Kruskal-Wallis|||Non-specific (Days 1, 3, 6 doctor's examination)||||0.0820
74011379|NCT01843842|147573547|SUPERIORITY|||||||0.7227|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1, 3, 6 doctor's examination)||||0.7227
74011380|NCT01843842|147573547|SUPERIORITY|||||||0.2645|||||||Kruskal-Wallis|||All symptoms (Days 1, 3, 6 doctor's examination)||||0.2645
74011381|NCT01843842|147573547|SUPERIORITY|||||||0.0142||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1-5, patient diary data)||||0.0142
74011382|NCT01843842|147573547|SUPERIORITY|||||||0.0145||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Non-specific (Days 1-5, patient diary data)||||0.0145
74011383|NCT01843842|147573547|SUPERIORITY|||||||0.2963|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1-5, patient diary data)||||0.2963
74011384|NCT01843842|147573547|SUPERIORITY|||||||0.0364||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||All symptoms (Days 1-5, patient diary data)||||0.0364
74011385|NCT01843842|147573548|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||0.40
74011386|NCT01977599|147573550|OTHER|Chi Square|||||<|0.001|||||||Chi-squared|||||||<0.001
74011387|NCT02375724|147573559|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.02||||0.0306|TWO_SIDED|95.0|-1.94|-0.1|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||-0.10|-1.94|0.0306
74011388|NCT02375724|147573560|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.22||||0.0793|TWO_SIDED|95.0|-0.46|0.03|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||0.03|-0.46|0.0793
74011389|NCT02375724|147573561|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.06||||0.844|TWO_SIDED|95.0|-0.64|0.52|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||0.52|-0.64|0.844
74011390|NCT01309659|147573566|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED|||||Correlation between ferritin and change in hemoglobin in the immediate intervention group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.308
74011391|NCT01309659|147573566|SUPERIORITY_OR_OTHER|||||||0.601|TWO_SIDED|||||Correlation between ferritin and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.601
74011392|NCT01309659|147573566|SUPERIORITY_OR_OTHER|||||||0.396|TWO_SIDED|||||Correlation between iron and change in hemoglobin in the intermediate intervention group. Testing the correlation = 0.|t-test, 2 sided|||||||0.396
74011393|NCT01309659|147573566|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED|||||Correlation between iron and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.106
74011394|NCT01309659|147573566|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED|||||Correlation between transferrin saturation and change in hemoglobin in the immediate intervention group. Testing the correlation = 0.|t-test, 2 sided|||||||0.606
74093811|NCT02944383|147738572|SUPERIORITY|||||||0.421||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||IDL Particles||||0.4210
74093812|NCT02944383|147738573|SUPERIORITY||Median Difference (Net)|0.43||||0.9672|TWO_SIDED|95.0|-8.12|9.07||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|||9.07|-8.12|0.9672
74093813|NCT02944383|147738573|SUPERIORITY||Median Difference (Net)|1.58||||0.7993|TWO_SIDED|95.0|-5.31|8.69||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|||8.69|-5.31|0.7993
74093814|NCT02944383|147738574|SUPERIORITY|||||||0.8602||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||||||0.8602
74093815|NCT02944383|147738574|SUPERIORITY|||||||0.8555||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||||||0.8555
73879612|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.94||0.002|TWO_SIDED|95.0|-9.88|-2.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.23|-9.88|0.0020
74011395|NCT01309659|147573566|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED|||||Correlation between transferrin saturation and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.077
74011396|NCT01309659|147573575|SUPERIORITY_OR_OTHER|||||||0.649|TWO_SIDED|||||Correlation between soluble transfer receptor and change in hemoglobin in the immediate intervention group. Testing the correlation =0.|t-test, 2 sided|||||||0.649
74011397|NCT01309659|147573575|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Correlation between soluble transfer receptor and change in hemoglobin in the wait list group. Testing the correlation =0.|t-test, 2 sided|||||||0.001
74011398|NCT01309659|147573576|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.391
74011399|NCT01309659|147573576|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the wait list control group. Testing correlation =0.|t-test, 2 sided|||||||0.111
74011400|NCT01309659|147573577|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED|||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.077
74011401|NCT01309659|147573577|SUPERIORITY_OR_OTHER|||||||0.798|TWO_SIDED|||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.798
74093816|NCT02944383|147738575|SUPERIORITY|||||||0.0583||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0583
74093817|NCT02944383|147738575|SUPERIORITY|||||||0.2289||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2289
73879613|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.93||0.0076|TWO_SIDED|95.0|-8.98|-1.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.39|-8.98|0.0076
74011402|NCT01309659|147573577|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED|||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.383
74011403|NCT01309659|147573577|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED|||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.732
74011404|NCT01309659|147573577|SUPERIORITY_OR_OTHER|||||||0.286|TWO_SIDED|||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.286
74011405|NCT01309659|147573577|SUPERIORITY_OR_OTHER|||||||0.356|TWO_SIDED|||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.356
74011406|NCT01309659|147573578|SUPERIORITY_OR_OTHER|||||||0.649|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.649
74011407|NCT01309659|147573578|SUPERIORITY_OR_OTHER|||||||0.396|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.396
74011408|NCT01309659|147573579|SUPERIORITY_OR_OTHER|||||||0.624|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the intermediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.624
74011409|NCT01309659|147573579|SUPERIORITY_OR_OTHER|||||||0.329|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.329
74011410|NCT00271596|147573591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166|STANDARD_ERROR_OF_MEAN|0.098||0.092|TWO_SIDED|95.0|-0.361|0.028|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.028|-0.361|0.092
74011411|NCT00271596|147573592|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.337|STANDARD_ERROR_OF_MEAN|0.168||0.048|TWO_SIDED|95.0|-0.672|-0.003|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||-0.003|-0.672|0.048
74011412|NCT00271596|147573593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.278|STANDARD_ERROR_OF_MEAN|0.268||0.302|TWO_SIDED|95.0|-0.81|0.254|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic)||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.254|-0.810|0.302
74011413|NCT00271596|147573594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.153||0.708|TWO_SIDED|95.0|-0.361|0.246|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.246|-0.361|0.708
74011414|NCT00271596|147573595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.15||0.646|TWO_SIDED|95.0|-0.229|0.367|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.367|-0.229|0.646
74011415|NCT00271596|147573596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.174||0.23||95.0|-0.554|0.135|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.135|-0.554|0.230
74011416|NCT00271596|147573597|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.317|STANDARD_ERROR_OF_MEAN|0.482||0.512|TWO_SIDED|95.0|-1.276|0.642|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.642|-1.276|0.512
74011417|NCT00271596|147573598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|1.17||0.12|TWO_SIDED|95.0|-4.3|0.5|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.50|-4.30|0.12
74011418|NCT00271596|147573599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.68||0.49|TWO_SIDED|95.0|-1.87|0.91|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.91|-1.87|0.49
74011419|NCT00271596|147573600|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-2.5|STANDARD_ERROR_OF_MEAN|1.23||0.05|TWO_SIDED|95.0|-5.04|0.04||Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|Mixed Models Analysis|||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.04|-5.04|0.05
74011420|NCT04707157|147573601|SUPERIORITY||Posterior Mean Difference|-1.56|||||TWO_SIDED|95.0|-2.76|-0.38|||||Posterior mean difference with 95% credible interval is reported.|||-0.38|-2.76|
74011421|NCT04707157|147573602|SUPERIORITY||Posterior Mean Difference|-1.03|||||TWO_SIDED|95.0|-2.14|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-2.14|
74011422|NCT04707157|147573603|SUPERIORITY||Posterior Mean Difference|-0.91|||||TWO_SIDED|95.0|-1.56|-0.25|||||Posterior mean difference with 95% credible interval is reported.|||-0.25|-1.56|
74011423|NCT04707157|147573604|SUPERIORITY||Posterior Mean Difference|-1.99|||||TWO_SIDED|95.0|-3.22|-0.77|||||Posterior mean difference with 95% credible interval is reported.|||-0.77|-3.22|
74011424|NCT04707157|147573605|SUPERIORITY||Posterior Mean Difference|-19.12|||||TWO_SIDED|95.0|-31.22|-6.97|||||Posterior mean difference with 95% credible interval is reported.|||-6.97|-31.22|
74011425|NCT04707157|147573606|SUPERIORITY||Posterior Mean Difference|-0.11|||||TWO_SIDED|95.0|-0.86|0.64|||||Posterior mean difference with 95% credible interval is reported.|||0.64|-0.86|
74011426|NCT04707157|147573607|SUPERIORITY||Posterior Mean Difference|-269.92|||||TWO_SIDED|95.0|-624.98|86.24|||||Posterior mean difference with 95% credible interval is reported.|||86.24|-624.98|
74011427|NCT04707157|147573608|SUPERIORITY||Posterior Mean Difference|0.03|||||TWO_SIDED|95.0|-0.22|0.29|||||Posterior mean difference with 95% credible interval is reported.|||0.29|-0.22|
74011428|NCT04206605|147573613|SUPERIORITY||Rate Ratio|1.02|||=|0.899|TWO_SIDED|95.0|0.71|1.47||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.47|0.71|=0.899
74011429|NCT04206605|147573614|SUPERIORITY||Risk Difference (RD)|0.003|||=|1|TWO_SIDED|95.0|-0.153|0.114||P-value was from the corresponding Mantel-Haenszel estimate for the common risk difference from Cochran-Mantel-Haenszel (CMH) test; unadjusted for multiple testing.|Cochran-Mantel-Haenszel|||||0.114|-0.153|=1.000
74011430|NCT04206605|147573615|SUPERIORITY||Rate Ratio|0.96|||=|0.852|TWO_SIDED|95.0|0.62|1.48||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.48|0.62|=0.852
74011431|NCT04206605|147573616|SUPERIORITY||Rate Ratio|1.1|||=|0.66|TWO_SIDED|95.0|0.72|1.7||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.70|0.72|=0.660
73879614|NCT03192176|147297614|SUPERIORITY||LSMean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.85||0.0182|TWO_SIDED|95.0|-8.01|-0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.75|-8.01|0.0182
73879615|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.84||0.0019|TWO_SIDED|95.0|-9.42|-2.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.16|-9.42|0.0019
73879616|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.86||0.0007|TWO_SIDED|95.0|-10.02|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.71|-10.02|0.0007
73879617|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|1.88||0.0002|TWO_SIDED|95.0|-10.76|-3.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-3.35|-10.76|0.0002
73879618|NCT03192176|147297614|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.88||0.0263|TWO_SIDED|95.0|-7.89|-0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.50|-7.89|0.0263
74011432|NCT04206605|147573617|SUPERIORITY||Risk Difference (RD)|-0.087|||=|0.25|TWO_SIDED|95.0|-0.28|0.063||P-value was from the corresponding Mantel-Haenszel estimate for the common risk difference from CMH test; unadjusted for multiple testing.|Cochran-Mantel-Haenszel|||||0.063|-0.280|=0.250
73879619|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0015|TWO_SIDED|95.0|-9.61|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.29|-9.61|0.0015
73879620|NCT03192176|147297614|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.84||0.0113|TWO_SIDED|95.0|-8.32|-1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.07|-8.32|0.0113
73879621|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.91||0.0059|TWO_SIDED|95.0|-9.04|-1.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.54|-9.04|0.0059
73879622|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.91||0.0018|TWO_SIDED|95.0|-9.76|-2.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.25|-9.76|0.0018
74011433|NCT04206605|147573619|SUPERIORITY||Rate Ratio|0.97|||=|0.896|TWO_SIDED|95.0|0.58|1.61||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.61|0.58|=0.896
74011434|NCT04206605|147573621|SUPERIORITY||||||=|0.498||||||P-value comparing lanadelumab to placebo was from a log rank test stratified by baseline strata.|Log Rank|||||||=0.498
74011435|NCT04206605|147573622|SUPERIORITY||||||=|0.184||||||P-value comparing lanadelumab to placebo was from a log rank test stratified by baseline strata.|Log Rank|||||||=0.184
73879623|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.93||0.0004|TWO_SIDED|95.0|-10.62|-3.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.05|-10.62|0.0004
73879624|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.95||0.0001|TWO_SIDED|95.0|-11.39|-3.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.73|-11.39|0.0001
73879625|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.94||0.0044|TWO_SIDED|95.0|-9.4|-1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-1.75|-9.40|0.0044
74011436|NCT04995055|147573639|SUPERIORITY||Least-square Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|2.81|||TWO_SIDED|95.0|-21.2|-9.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-9.5|-21.2|
74011437|NCT04995055|147573640|SUPERIORITY||Least-square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|0.2|0.4|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||0.4|0.2|
74011438|NCT04995055|147573641|SUPERIORITY||Least-square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-4.9|-2.1|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-2.1|-4.9|
74011439|NCT04995055|147573642|SUPERIORITY||Least-square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|0.2|0.4|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||0.4|0.2|
74011440|NCT04995055|147573644|SUPERIORITY||Least-square Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-4.4|-1.9|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-1.9|-4.4|
74011441|NCT02662036|147573645|SUPERIORITY|||||||0.76|||||||Mann Whitney U Test|||Statistical analysis #1 is for intraoperative opioid use||||0.76
74011442|NCT02662036|147573645|SUPERIORITY|||||||0.38|||||||Mann Whitney U Test|||Statistical analysis #2 is for postoperative acute care unit opioid use||||0.38
74011443|NCT02662036|147573645|SUPERIORITY|||||||0.69|||||||Mann Whitney U Test|||Statistical analysis #3 is for postoperative floor opioid use||||0.69
74011444|NCT02662036|147573645|SUPERIORITY|||||||0.98|||||||Mann Whitney U Test|||Statistical analysis #4 is for total opioid use||||0.98
74011445|NCT02662036|147573646|SUPERIORITY|||||||0.28|||||||Mann Whitney U Test|||Statistical analysis #1 is for postoperative acute care unit antiemetic use||||0.28
74011446|NCT02662036|147573646|SUPERIORITY|||||||0.62|||||||Mann Whitney U Test|||Statistical analysis #2 is for floor antiemetic use||||0.62
74011447|NCT02662036|147573646|SUPERIORITY|||||||0.5|||||||Mann Whitney U Test|||Statistical analysis #3 is for total antiemetic use||||0.50
74011448|NCT02662036|147573647|SUPERIORITY|||||||0.2|||||||Mann Whitney U Test|||||||0.20
74011449|NCT02662036|147573648|SUPERIORITY|||||||0.64|||||||Mann Whitney U Test|||||||0.64
74011450|NCT02662036|147573649|SUPERIORITY|||||||0.38|||||||Mann Whitney U Test|||||||0.38
74011451|NCT00884273|147573660|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Final Values)|2.37||||0.36|TWO_SIDED|95.0|-2.78|7.52||FAS.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||7.52|-2.78|0.36
74011452|NCT00884273|147573669|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Net)|2.24||||0.41|TWO_SIDED|95.0|-3.1|7.58||PP.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||7.58|-3.10|0.41
74011453|NCT00578136|147573676|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|The Wilcoxon rank-sum test was used because the study did not have a normal distribution using the Kolmogorov-Smirnov test (p\<0.01).||Assuming the opioid requirement in the local infiltration group to be 0.2mg kg-1 and in the rectus sheath block group to be 0.1mg kg-1, a sample size of 44 patients (22 in each group) will have a power of 80% to detect a difference in means of 0.1mg kg-1 with a 0.005 two-sided significance level.||||0.008
74011454|NCT02321930|147573740|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
74011455|NCT02321930|147573741|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
74011456|NCT02321930|147573742|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
74011457|NCT02321930|147573743|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
74011458|NCT02321930|147573744|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
74011459|NCT05321069|147573745|SUPERIORITY||Mean Difference (Net)|44.89||||0.0222|TWO_SIDED|95.0|6.44|83.33|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 9 mg bid group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.||83.33|6.44|0.0222
74011460|NCT05321069|147573745|SUPERIORITY||Mean Difference (Net)|68.83||||0.0005|TWO_SIDED|95.0|30.26|107.39|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 18 mg bid group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.||107.39|30.26|0.0005
74093818|NCT02944383|147738575|SUPERIORITY|||||||0.0416||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0416
74093819|NCT02944383|147738575|SUPERIORITY|||||||0.015||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0150
74093820|NCT02944383|147738575|SUPERIORITY||Median Difference (Net)|-26.21||||0.0718|TWO_SIDED|95.0|-54.29|-1.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.26|-54.29|0.0718
73879626|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.92||0.0006|TWO_SIDED|95.0|-10.4|-2.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.84|-10.40|0.0006
74011461|NCT05321069|147573746|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.5443|TWO_SIDED|95.0|0.69|1.22|||Regression, Cox|||The hazard ratio (HR) was estimated using a Cox proportional hazards model with treatment group, baseline antifibrotic therapy use, age (continuous), baseline FVC % predicted, and baseline DLCO % predicted (hemoglobin-corrected) as covariates. Breslow's method was applied for tied event times. A two-sided p-value from the Wald test assessed the treatment effect. P-values were not adjusted for multiplicity.||1.22|0.69|0.5443
74011462|NCT05321069|147573746|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9512|TWO_SIDED|95.0|0.75|1.31|||Regression, Cox|||Based on Cox proportional hazards model including treatment, baseline antifibrotic therapy, age, baseline Forced Vital Capacity (FVC) percent predicted, and baseline Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) percent predicted (corrected for haemoglobin) as covariates. p-values not adjusted for multiplicity.||1.31|0.75|0.9512
74011463|NCT05321069|147573747|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.5583|TWO_SIDED|95.0|0.76|1.67|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.67|0.76|0.5583
74011464|NCT05321069|147573747|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5896|TWO_SIDED|95.0|0.75|1.65|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.65|0.75|0.5896
74011465|NCT05321069|147573748|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9038|TWO_SIDED|95.0|0.7|1.36|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.36|0.70|0.9038
74011466|NCT05321069|147573748|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.4687|TWO_SIDED|95.0|0.82|1.56|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.56|0.82|0.4687
74011467|NCT05321069|147573749|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.7695|TWO_SIDED|95.0|0.74|1.25|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.25|0.74|0.7695
74011468|NCT05321069|147573749|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.2068|TWO_SIDED|95.0|0.64|1.1|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.10|0.64|0.2068
74011469|NCT05321069|147573750|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9251|TWO_SIDED|95.0|0.69|1.41|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.41|0.69|0.9251
74011470|NCT05321069|147573750|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4988|TWO_SIDED|95.0|0.62|1.26|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.26|0.62|0.4988
74011471|NCT05321069|147573751|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9084|TWO_SIDED|95.0|0.6|1.76|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.76|0.60|0.9084
74011472|NCT05321069|147573751|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4682|TWO_SIDED|95.0|0.46|1.43|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.43|0.46|0.4682
73887989|NCT01746901|147309529|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.0901|TWO_SIDED|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.9|-1.7|0.0901
74041975|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.81|0.6922
74041976|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.9765|TWO_SIDED|95.0|0.82|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.82|0.9765
74041977|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6572|TWO_SIDED|95.0|0.84|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.84|0.6572
74041978|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.7918|TWO_SIDED|95.0|0.86|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.86|0.7918
74041979|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.2514|TWO_SIDED|95.0|0.79|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.79|0.2514
74041980|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.9872|TWO_SIDED|95.0|0.88|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.88|0.9872
74041981|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.6304|TWO_SIDED|95.0|0.78|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.78|0.6304
74041982|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.7918|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.7918
74041983|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.8|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.80|0.6922
74041984|NCT01392378|147635955|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.9765|TWO_SIDED|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.81|0.9765
74041985|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7148|TWO_SIDED|95.0|0.82|1.66||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.66|0.82|0.7148
74041986|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.7907|TWO_SIDED|95.0|0.75|1.45||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.45|0.75|0.7907
74041987|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.4765|TWO_SIDED|95.0|0.81|1.6||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.60|0.81|0.4765
74041988|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.5037|TWO_SIDED|95.0|0.89|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.76|0.89|0.5037
74041989|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.9414|TWO_SIDED|95.0|0.52|2.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.17|0.52|0.9414
74041990|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7907|TWO_SIDED|95.0|0.45|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.71|0.45|0.7907
74041991|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.29|TWO_SIDED|95.0|0.32|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.32|0.2900
74041992|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.44|1.77||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.77|0.44|0.8826
74011473|NCT05321069|147573752|SUPERIORITY||Mean Difference (Net)|-1.0||||0.3697|TWO_SIDED|95.0|-3.2|1.19|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 9mg BID group and the Placebo group at Week 52.|The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.||1.19|-3.20|0.3697
74011474|NCT05321069|147573752|SUPERIORITY||Mean Difference (Net)|-0.63||||0.5734|TWO_SIDED|95.0|-2.83|1.57|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 18mg BID group and the Placebo group at Week 52.|The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.||1.57|-2.83|0.5734
74011475|NCT05321069|147573753|SUPERIORITY||Mean Difference (Net)|-0.1||||0.9442|TWO_SIDED|95.0|-2.98|2.77|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 9 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.77|-2.98|0.9442
74011476|NCT05321069|147573753|SUPERIORITY||Mean Difference (Net)|-0.59||||0.6862|TWO_SIDED|95.0|-3.47|2.28|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 18 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.28|-3.47|0.6862
74011477|NCT05321069|147573754|SUPERIORITY||Mean Difference (Net)|0.19||||0.8759|TWO_SIDED|95.0|-2.25|2.63|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 9 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.63|-2.25|0.8759
74011478|NCT05321069|147573754|SUPERIORITY||Mean Difference (Net)|0.43||||0.732|TWO_SIDED|95.0|-2.02|2.87|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 18 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.87|-2.02|0.7320
74011479|NCT05321069|147573755|SUPERIORITY||Mean Difference (Net)|1.17||||0.028|TWO_SIDED|95.0|0.13|2.22|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 9 mg BID group and the placebo group at Week 52.|"Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate."||2.22|0.13|0.0280
74011480|NCT05321069|147573755|SUPERIORITY||Mean Difference (Net)|1.73||||0.0013|TWO_SIDED|95.0|0.68|2.78|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 18 mg BID group and the placebo group at Week 52.|"Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate."||2.78|0.68|0.0013
74041993|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.5||||0.5823|TWO_SIDED|95.0|0.18|1.4||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.40|0.18|0.5823
74041994|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.7636|TWO_SIDED|95.0|0.27|1.8||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.80|0.27|0.7636
74041995|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.4||||0.2407|TWO_SIDED|95.0|0.14|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.14|0.2407
74041996|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.8826|TWO_SIDED|95.0|0.43|3.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||3.22|0.43|0.8826
74041997|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.5||||0.0961|TWO_SIDED|95.0|0.26|0.81||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.81|0.26|0.0961
74041998|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.7636|TWO_SIDED|95.0|0.38|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.38|0.7636
74041999|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.29|TWO_SIDED|95.0|0.39|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.39|0.2900
74042000|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.8826|TWO_SIDED|95.0|0.6|1.82||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.82|0.60|0.8826
74042001|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.9925|TWO_SIDED|95.0|0.65|1.54||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.54|0.65|0.9925
74093821|NCT02944383|147738575|SUPERIORITY||Median Difference (Net)|-18.68||||0.1248|TWO_SIDED|95.0|-50.0|7.31||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.31|-50.00|0.1248
74093822|NCT02944383|147738576|SUPERIORITY|||||||0.2397||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2397
74093823|NCT02944383|147738576|SUPERIORITY|||||||0.5399||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5399
74093824|NCT02944383|147738576|SUPERIORITY|||||||0.0409||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0409
74042002|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.7636|TWO_SIDED|95.0|0.52|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.52|0.7636
74042003|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.3929|TWO_SIDED|95.0|0.53|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.53|0.3929
74093825|NCT02944383|147738576|SUPERIORITY|||||||0.0073||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0073
74093826|NCT02944383|147738576|SUPERIORITY|||||||0.0976||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0976
74093827|NCT02944383|147738576|SUPERIORITY|||||||0.1899||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1899
74011481|NCT05321069|147573756|SUPERIORITY||Mean Difference (Net)|2.49||||0.0042|TWO_SIDED|95.0|0.79|4.19|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 9 mg BID group and the placebo group at Week 52.|"Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate."||4.19|0.79|0.0042
74011482|NCT05321069|147573756|SUPERIORITY||Mean Difference (Net)|1.67||||0.053|TWO_SIDED|95.0|-0.02|3.37|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 18 mg BID group and the placebo group at Week 52.|"Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate."||3.37|-0.02|0.0530
74011483|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 4||14.2|-5.0|
74011484|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 6B||9.5|-7.3|
74011485|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 9V||9.5|-7.3|
74011486|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.8|9.5||||||Comparison between treatments for common serotype 14||9.5|-7.8|
74011487|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 18C||14.2|-5.0|
74011488|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 19F||9.5|-7.3|
74042004|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.62|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.62|0.8826
74011489|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 23F||9.5|-7.3|
74011490|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1||14.2|-5.0|
74042005|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7433|TWO_SIDED|95.0|0.7|2.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.20|0.70|0.7433
74042006|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.7636|TWO_SIDED|95.0|0.46|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.35|0.46|0.7636
73887990|NCT01746901|147309529|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8||||0.1313|TWO_SIDED|95.0|-3.0|22.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.6|-3.0|0.1313
74011491|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 3||9.5|-7.3|
74011492|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 5||9.5|-7.3|
74011493|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A||9.5|-7.3|
74011494|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 7F||9.5|-7.3|
74011495|NCT00853749|147573757|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A||9.5|-7.3|
74011496|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.8|||||TWO_SIDED|95.0|-8.6|12.7||||||Comparison between treatments for common serotype 4||12.7|-8.6|
74011497|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 6B||9.7|-7.5|
74011498|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 9V||9.7|-7.5|
74011499|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 14||9.7|-7.5|
74011500|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.4|10.0||||||Comparison between treatments for common serotype 18C||10.0|-7.4|
74011501|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|10.0||||||Comparison between treatments for common serotype 19F||10.0|-7.5|
74011502|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-10.8|8.1||||||Comparison between treatments for common serotype 23F||8.1|-10.8|
74011503|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1||14.2|-5.0|
74011504|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-11.1|7.9||||||Comparison between treatments for additional serotype 3||7.9|-11.1|
74011505|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.7|||||TWO_SIDED|95.0|-8.5|12.2||||||Comparison between treatments for additional serotype 5||12.2|-8.5|
74011506|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A||9.5|-7.3|
74011507|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-11.3|7.7||||||Comparison between treatments for additional serotype 7F||7.7|-11.3|
74011508|NCT00853749|147573758|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A||9.5|-7.3|
74011509|NCT00853749|147573759|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.3|||||TWO_SIDED|95.0|0.22|0.42|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.42|0.22|
74011510|NCT00853749|147573759|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.32|||||TWO_SIDED|95.0|0.23|0.44|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ((PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.44|0.23|
74011511|NCT00853749|147573759|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.44|||||TWO_SIDED|95.0|0.29|0.67|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.67|0.29|
74011512|NCT00853749|147573759|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.88|||||TWO_SIDED|95.0|0.61|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.27|0.61|
74011513|NCT00853749|147573759|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.47|||||TWO_SIDED|95.0|0.34|0.65|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.65|0.34|
74011514|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.35|1.12|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.12|0.35|
74042007|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.2407|TWO_SIDED|95.0|0.34|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.34|0.2407
74042008|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.8826|TWO_SIDED|95.0|0.61|1.83||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.83|0.61|0.8826
74093828|NCT02944383|147738577|SUPERIORITY|||||||0.1747||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1747
74011515|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.68|1.38|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.38|0.68|
74011516|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.51|1.81|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.81|0.51|
74011517|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.67|1.48|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.48|0.67|
74011518|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.33|0.98|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures(PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.98|0.33|
74011519|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.1|||||TWO_SIDED|95.0|0.72|1.56|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.56|0.72|
74011520|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.39|0.99|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.99|0.39|
74011521|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.2|||||TWO_SIDED|95.0|0.12|0.32|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.32|0.12|
74011522|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.56|1.18|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.18|0.56|
73879627|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.91||0.0025|TWO_SIDED|95.0|-9.57|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.07|-9.57|0.0025
74011523|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.4|||||TWO_SIDED|95.0|0.21|0.63|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.63|0.21|
74011524|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.4|||||TWO_SIDED|95.0|0.88|2.25|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||2.25|0.88|
74011525|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.7|||||TWO_SIDED|95.0|0.48|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.14|0.48|
74011526|NCT00853749|147573760|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.54|1.2|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.20|0.54|
74011527|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.37|||||TWO_SIDED|95.0|0.25|0.55|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.55|0.25|
74011528|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.71|||||TWO_SIDED|95.0|0.44|1.15|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.15|0.44|
74011529|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.58|||||TWO_SIDED|95.0|0.45|0.75|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.75|0.45|
74011530|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.48|1.24|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.24|0.48|
74011531|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.57|||||TWO_SIDED|95.0|0.38|0.85|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.85|0.38|
74011532|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.56|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.27|0.56|
74011533|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.64|||||TWO_SIDED|95.0|0.44|0.95|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.95|0.44|
74011534|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.27|||||TWO_SIDED|95.0|0.18|0.4|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.40|0.18|
74011535|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|1.14|||||TWO_SIDED|95.0|0.76|1.72|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.72|0.76|
74011536|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.36|||||TWO_SIDED|95.0|0.25|0.51|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.51|0.25|
74011537|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.55|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.14|0.55|
74011538|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.61|1.28|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.28|0.61|
74011539|NCT00853749|147573761|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.6|1.23|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.23|0.60|
74042009|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.9414|TWO_SIDED|95.0|0.51|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.71|0.51|0.9414
74042010|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7636|TWO_SIDED|95.0|0.68|2.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.14|0.68|0.7636
74042011|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.738|TWO_SIDED|95.0|0.5|1.63||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.63|0.50|0.7380
74011540|NCT00853749|147573762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.253|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any tenderness||||0.253
74011541|NCT00853749|147573762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for significant tenderness||||0.380
74011542|NCT00853749|147573762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.135|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any redness||||0.135
74011543|NCT00853749|147573762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for mild redness||||0.520
74011544|NCT00853749|147573762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for moderate redness||||0.283
74011545|NCT00853749|147573762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.225|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for severe redness||||0.225
74011546|NCT00853749|147573762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any swelling||||0.202
74011547|NCT00853749|147573762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for mild swelling||||0.294
74011548|NCT00853749|147573762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for moderate swelling||||0.175
74011549|NCT00853749|147573762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.314|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for severe swelling||||0.314
74011550|NCT00853749|147573763|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for fever ≥ 38 degrees C but ≤ 39 degrees C||||> .99
74011551|NCT00853749|147573763|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for decreased appetite||||> .99
74011552|NCT00853749|147573763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.543|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for irritability||||0.543
74011553|NCT00853749|147573763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.233|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for increased sleep||||0.233
74011554|NCT00853749|147573763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for decreased sleep||||0.198
74011555|NCT00853749|147573763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.628|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for rash||||0.628
74011556|NCT01392677|147573782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.1022|<|0.0001|TWO_SIDED|95.0|-0.89|-0.49||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Mixed Models Analysis|Longitudinal repeated measures model using mixed model with treatment group, baseline value, week and week\*treatment and week\*baseline||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.49|-0.89|<0.0001
74011557|NCT01392677|147573783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.45|STANDARD_ERROR_OF_MEAN|4.8846|<|0.0001|TWO_SIDED|95.0|-43.08|-23.82||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-23.82|-43.08|<0.0001
74011558|NCT01392677|147573784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|0.3651|<|0.0001|TWO_SIDED|95.0|-2.79|-1.35||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.35|-2.79|<0.0001
74011559|NCT01392677|147573785|SUPERIORITY_OR_OTHER||Risk Difference (RD)|20.7|STANDARD_ERROR_OF_MEAN|5.056|<|0.0001|TWO_SIDED|95.0|10.7|30.6||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Tsiatis, Davidian, Zhang \& Lu, with adjustment for baseline value||H0: proportion(treat) minus proportion (placebo) = 0 versus the alternative HA: proportion (treat) minus proportion (placebo) =/= 0||30.6|10.7|<0.0001
74011560|NCT01392677|147573786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|1.6677||0.025|TWO_SIDED|95.0|-7.05|-0.48||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.48|-7.05|0.025
74011561|NCT03996876|147573787|SUPERIORITY|Given the relatively small sample size, results of our inferential statistical tests should be interpreted with caution.|F Statistic|1.032||||0.322|TWO_SIDED|||||The a priori threshold for statistical significance was set at 0.05.|ANOVA|We conducted a two-way mixed ANOVA with intervention as the between-subjects and time as the within-subjects variable.|The F Statistic reported is for the interaction between Intervention and Time.|||||0.322
74011562|NCT02726971|147573790|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
74011563|NCT00597753|147573824|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.3|-0.01|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin alfa group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.||-0.01|-0.30|
74011564|NCT00597753|147573825|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.76|1.92|||Cochran-Mantel-Haenszel|||||1.92|0.76|
74011565|NCT00597753|147573826|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.97|||Cochran-Mantel-Haenszel|||||0.97|0.79|
74011566|NCT03080883|147573827|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.3117|TWO_SIDED|95.0|0.38|1.37|||Gray Test P-value|||||1.37|0.38|0.3117
74011567|NCT03080883|147573828|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.997|TWO_SIDED|95.0|0.4|2.53|||Gray Test P-value|||||2.53|0.40|0.9970
74093829|NCT02944383|147738577|SUPERIORITY|||||||0.4576||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4576
74093830|NCT02944383|147738577|SUPERIORITY|||||||0.1549||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1549
74093831|NCT02944383|147738577|SUPERIORITY|||||||0.2427||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2427
74011568|NCT03451851|147573830|SUPERIORITY||Difference in percentage|49.9|||<|0.001|TWO_SIDED|95.0|25.9|69.4|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||69.4|25.9|<0.001
74011569|NCT03451851|147573831|SUPERIORITY||Difference in percentage|55.6|||<|0.001|TWO_SIDED|95.0|32.1|74.0|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||74.0|32.1|<0.001
74011570|NCT03451851|147573832|SUPERIORITY||Difference in percentage|40.1|||=|0.003|TWO_SIDED|95.0|15.6|61.3|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||61.3|15.6|=0.003
74011571|NCT03451851|147573833|SUPERIORITY||Difference in percentage|35.0|||=|0.004|TWO_SIDED|95.0|10.5|56.8|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||56.8|10.5|=0.004
74011572|NCT03451851|147573834|SUPERIORITY||Difference in percentage|34.1|||=|0.002|TWO_SIDED|25.0|9.7|56.1|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||56.1|9.7|=0.002
74011573|NCT03451851|147573835|SUPERIORITY||LS Mean difference|-5.4|||<|0.001|TWO_SIDED|95.0|-7.33|-3.06|||Mixed model repeated measures (MMRM)|||Guselkumab Vs Placebo||-3.06|-7.33|<0.001
74011574|NCT03451851|147573841|SUPERIORITY||Difference in percentage|59.8|||<|0.001|TWO_SIDED|95.0|36.9|77.6||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||77.6|36.9|<0.001
74011575|NCT03451851|147573849|SUPERIORITY||Difference in percentage|46.7|||=|0.002|TWO_SIDED|95.0|21.9|67.3||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||||67.3|21.9|=0.002
74011576|NCT03451851|147573851|SUPERIORITY||Difference in Percentage|23.1|||=|0.139|TWO_SIDED|95.0|-3.4|47.0||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||47.0|-3.4|=0.139
74011577|NCT03451851|147573853|SUPERIORITY||Difference in LS Mean|-5.44|||<|0.001|TWO_SIDED|95.0|-8.0|-2.87||p-value is nominal|MMRM model|||Guselkumab Vs Placebo||-2.87|-8.00|<0.001
74011578|NCT03451851|147573855|SUPERIORITY||LS Mean difference|-14.78|||<|0.001|TWO_SIDED|95.0|-20.28|-9.28||p-value is nominal|MMRM model|||Guselkumab Vs Placebo||-9.28|-20.28|<0.001
74042012|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.49|1.58||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.58|0.49|0.8826
74042013|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.9414|TWO_SIDED|95.0|0.67|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.65|0.67|0.9414
74093832|NCT02944383|147738577|SUPERIORITY||Median Difference (Net)|1.51||||0.1379|TWO_SIDED|95.0|-6.26|8.73||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||8.73|-6.26|0.1379
73879628|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.86||0.0059|TWO_SIDED|95.0|-8.81|-1.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.49|-8.81|0.0059
73879629|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.86||0.0007|TWO_SIDED|95.0|-10.06|-2.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.74|-10.06|0.0007
74011579|NCT05885737|147573865|EQUIVALENCE|Testing of primary efficacy endpoint was 2-sided and conducted at the 5% significance level. The efficacy of difelikefalin was to be declared for this study if null hypothesis of no treatment difference in the primary efficacy analysis was rejected in favor of the alternative that participants randomized to difelikefalin experience significantly different itching compared to participants randomized to placebo. The null hypothesis was to be rejected if the 2-sided p value was less than (\<) 0.05.|Least square mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.223||0.0003|TWO_SIDED|95.0|-1.25|-0.37|||MMRM|||The null hypothesis in this study was that there was no treatment difference in the primary efficacy analysis of the primary endpoint. The alternative hypothesis was that in participants randomized to difelikefalin there was a significant treatment difference in change in itching compared to participants randomized to placebo. The assessment was based on the mean change from baseline in the weekly mean of the daily 24-hour WI-NRS score at Week 4 of the DB period.||-0.37|-1.25|0.0003
74011580|NCT04360551|147573894|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
74011581|NCT04360551|147573895|SUPERIORITY||||||>|0.5|||||||Kruskal-Wallis|||||||>0.5
74011582|NCT00346073|147573932|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.43|||||TWO_SIDED|95.0|-1.47|0.84||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-diphtheria (anti-D) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.||0.84|-1.47|
74011583|NCT00346073|147573932|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.42|||||TWO_SIDED|95.0|-0.9|0.11||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.||0.11|-0.9|
74011584|NCT00346073|147573933|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-1.04|||||TWO_SIDED|95.0|-1.97|0.0||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 1.0 IU/mL, one month after vaccination.||0|-1.97|
74011585|NCT00346073|147573935|SUPERIORITY||Booster response|77.2|||||TWO_SIDED|95.0|74.9|79.3||||||"Demonstration that anti-PT booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||79.3|74.9|
74011586|NCT00346073|147573935|SUPERIORITY||Booster response|96.9|||||TWO_SIDED|95.0|95.8|97.7||||||"Demonstration that anti-FHA booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||97.7|95.8|
74011587|NCT00346073|147573935|SUPERIORITY||Booster response|93.2|||||TWO_SIDED|95.0|91.8|94.4||||||"Demonstration that anti-PRN booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||94.4|91.8|
74011588|NCT04342871|147573970|OTHER|Pre-post comparison from baseline to 2-weeks post-intervention||||||0.2|||||||t-test, 2 sided|||||||0.2
74011589|NCT03670953|147573971|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.226||0.0194|TWO_SIDED|95.0|0.09|0.97||"LSM, SE, CI and p-value from a MMRM with CFB in Good on time as outcome, baseline Good on time as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction."|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||0.97|0.09|0.0194
73879630|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.18|-3.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.79|-11.18|<0.0001
73879631|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.9||0.0001|TWO_SIDED|95.0|-11.18|-3.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.72|-11.18|0.0001
74011590|NCT03670953|147573972|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.214||0.0252|TWO_SIDED|95.0|-0.9|-0.06||"LSM, SE, CI and p-value from a MMRM with CFB in Off time as outcome, baseline Off time as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction."|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||-0.06|-0.90|0.0252
74011591|NCT03670953|147573973|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Percent difference|10.9||||0.0015|TWO_SIDED|95.0|3.5|18.3||"P-value from the Cochran-Mantel-Haenszel test stratified by pooled center comparing the percentage of Much or Very Much Improved participants between the treatment groups."|Cochran-Mantel-Haenszel|||||18.3|3.5|0.0015
74011592|NCT03670953|147573974|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.89||0.9587|TWO_SIDED|95.0|-1.8|1.7||LSM, SE, CI and p-value from a MMRM with CFB in MDS-UPDRS Part III Score as outcome, baseline MDS-UPDRS Part III Score as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction.|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||1.7|-1.8|0.9587
74011593|NCT03670953|147573975|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.11||0.9668|TWO_SIDED|95.0|-2.2|2.1||LSM, SE, CI \& p-value from MMRM with CFB in MDS-UPDRS Part II \& III Scores as outcome, baseline MDS-UPDRS Part II and III Scores as a covariate, treatment and visit as fixed effects, pooled center as random effect \& a treatment-by-visit interaction.|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||2.1|-2.2|0.9668
74011594|NCT00666458|147573980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.01|0.2||||||||0.20|-0.01|
74011595|NCT00666458|147573981|SUPERIORITY_OR_OTHER||Difference in Percent|-2.8|||||TWO_SIDED|95.0|-9.0|3.5||||||||3.5|-9.0|
74011596|NCT00666458|147573982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.42|STANDARD_ERROR_OF_MEAN|2.064|||TWO_SIDED|95.0|1.37|9.47||||||||9.47|1.37|
74011597|NCT00666458|147573983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.115|||TWO_SIDED|95.0|0.08|0.53||||||||0.53|0.08|
74011598|NCT02603120|147574005|NON_INFERIORITY|A sample size of 260 participants per treatment group would provide at least 90% power to detect a noninferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48, between B/F/TAF group and ABC/DTG/3TC group. Sample size was based on assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48 and that the non-inferiority margin is 4%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|0.7|||||TWO_SIDED|95.002|-1.0|2.8|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||2.8|-1.0|
74011599|NCT02603120|147574005|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
74011600|NCT02603120|147574006|NON_INFERIORITY|It would be concluded that B/F/TAF is noninferior to ABC/DTG/3TC if the lower bound of the 2-sided 95.002% CI of the difference between treatment groups (B/F/TAF group -ABC/DTG/3TC group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|-1.4|||||TWO_SIDED|95.002|-5.5|2.6|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||2.6|-5.5|
74011601|NCT02603120|147574006|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||.59
74011602|NCT02603120|147574007|OTHER||Difference in least squares means|-35.0||||0.031|TWO_SIDED|95.0|-67.0|-3.0|||ANOVA|||||-3|-67|0.031
74011603|NCT02603120|147574009|OTHER||Difference in least squares means|0.276||||0.33|TWO_SIDED|95.0|-0.275|0.827|||ANOVA|||||0.827|-0.275|0.33
74011604|NCT02603120|147574011|OTHER||Difference in least squares means|-0.143||||0.47|TWO_SIDED|95.0|-0.534|0.248|||ANOVA|||||0.248|-0.534|0.47
74011605|NCT01761292|147574039|OTHER||mean|13.906|||<|0.0001|TWO_SIDED|95.0|11.5657|16.2466||The paired t-test or non-parametric signed rank test for 2 means (paired observations) (as is appropriate) was applied for testing the statistical significance of the Change From Baseline to End of Study. MFA% P \< 0.05 was set as significant.|t-test, 2 sided|||||16.2466|11.5657|<0.0001
74011606|NCT01761292|147574040|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||< 0.0001
74011607|NCT04036708|147574054|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|2.33||0.77|TWO_SIDED|95.0|-3.93|5.32||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||5.32|-3.93|.77
74011608|NCT04036708|147574054|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.44||0.9|TWO_SIDED|95.0|-5.14|4.54||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||4.54|-5.14|.90
74042014|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7907|TWO_SIDED|95.0|0.58|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.58|0.7907
74011609|NCT04036708|147574055|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|64.03|STANDARD_ERROR_OF_MEAN|24.55||0.01|TWO_SIDED|95.0|15.26|112.8||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, the HOME score, child's age and sex were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||112.8|15.26|.01
74011610|NCT04036708|147574055|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-37.53|STANDARD_ERROR_OF_MEAN|24.86||0.13|TWO_SIDED|95.0|-86.92|11.85||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, the HOME score, and child's age and sex were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||11.85|-86.92|.13
74011611|NCT04036708|147574056|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|2.97||0.55|TWO_SIDED|95.0|-7.65|4.13||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome and household material possessions were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||4.13|-7.65|.55
74011612|NCT04036708|147574056|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|3.05||0.26|TWO_SIDED|95.0|-9.48|2.63||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome and household material possessions were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.63|-9.48|.26
74011613|NCT04036708|147574057|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.16||0.32|TWO_SIDED|95.0|-0.48|0.16||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||0.16|-0.48|.32
74011614|NCT04036708|147574057|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|95.0|-0.72|-0.06||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||-0.06|-0.72|.02
74011615|NCT04036708|147574058|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.2||0.06|TWO_SIDED|95.0|-0.78|0.01||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||0.01|-0.78|.06
74011616|NCT04036708|147574058|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.001|TWO_SIDED|95.0|-1.11|-0.28||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||-0.28|-1.11|.001
74042015|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2407|TWO_SIDED|95.0|0.43|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.43|0.2407
74011617|NCT04036708|147574059|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.49||0.04|TWO_SIDED|95.0|0.07|2.03||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.03|0.07|.04
74093833|NCT02944383|147738577|SUPERIORITY||Median Difference (Net)|-6.02||||0.249|TWO_SIDED|95.0|-13.1|0.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.51|-13.10|0.2490
74093834|NCT02944383|147738578|SUPERIORITY|||||||0.155||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1550
74011618|NCT04036708|147574059|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.51||0.07|TWO_SIDED|95.0|-0.08|1.96||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||1.96|-0.08|.07
74093835|NCT02944383|147738578|SUPERIORITY|||||||0.6604||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.6604
73887991|NCT01746901|147309529|SUPERIORITY_OR_OTHER||LS Mean Difference|10.8||||0.0982|TWO_SIDED|95.0|-2.0|23.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.6|-2.0|0.0982
74011619|NCT04036708|147574060|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|2.04|STANDARD_ERROR_OF_MEAN|0.51|<|0.01|TWO_SIDED|95.0|1.02|3.06||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||3.06|1.02|<.01
74011620|NCT04036708|147574060|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.53|<|0.01|TWO_SIDED|95.0|0.67|2.79||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.79|0.67|<.01
74011621|NCT02535715|147574069|SUPERIORITY|ANOVA Bonferroni adjustment|||||<|0.05|||||||ANOVA|||||||<0.05
74011622|NCT02933034|147574071|OTHER|||||||0.001|||||||t-test, 2 sided|||Comparison of infarct size using MEMRI versus DEMRI scan||||0.001
74011623|NCT01265615|147574119|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74011624|NCT01265615|147574120|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74011625|NCT01265615|147574121|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74011626|NCT01265615|147574122|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74011627|NCT01265615|147574123|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74011628|NCT01265615|147574124|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74011629|NCT01265615|147574125|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74011630|NCT01265615|147574126|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74011631|NCT01265615|147574127|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74011632|NCT01265615|147574128|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74011633|NCT00632099|147574136|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
74011634|NCT01923285|147574166|NON_INFERIORITY|The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||<|0.0001||||||The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|Chi-squared|||"The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.~If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025."||||<0.0001
74093836|NCT02944383|147738578|SUPERIORITY|||||||0.0952||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0952
74093837|NCT02944383|147738578|SUPERIORITY|||||||0.3006||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3006
74093838|NCT02944383|147738578|SUPERIORITY|||||||0.0642||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0642
74011635|NCT01923285|147574166|SUPERIORITY|The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025|||||=|0.0004|||||||Chi-squared|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||=0.0004
74011636|NCT01923285|147574167|OTHER|Comparison of the mean difference. Difference in intensities is calculated as the supine paresthesia intensity minus the upright paresthesia intensity.|Mean Difference (Net)|1.9|||<|0.0001|TWO_SIDED|95.0|1.0|2.8|||Wilcoxon (Mann-Whitney)||Difference in paresthesia intensities is calculated as the supine paresthesia score minus the upright paresthesia score for each subject.|"Secondary endpoint compared the mean differences in upright and supine paresthesia scores between the Axium and Control groups at three months post INS implant. This endpoint was evaluated at a two-sided significance level of 0.05.~The primary hypothesis tested was: H0: μ0- μ1≤0 vs. H1: μ0- μ1\>0 where μ0 is the mean difference in paresthesia intensities in the Control group and μ1 is the mean difference in the Axium group."||2.8|1.0|<0.0001
74011637|NCT01923285|147574168|NON_INFERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||<|0.0001|||||||Chi-squared|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||<0.0001
74093839|NCT02944383|147738578|SUPERIORITY|||||||0.3185||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3185
74093840|NCT02944383|147738579|SUPERIORITY|||||||0.0679||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0679
74011638|NCT01923285|147574168|SUPERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||=|0.0047|||||||Chi-squared|||||||=0.0047
74011639|NCT01923285|147574169|NON_INFERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.||||||0.0003|||||||Non-inferiority|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||0.0003
74011640|NCT00807742|147574209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.606|TWO_SIDED|95.0|0.57|2.63|||Chi-squared|||||2.63|0.57|.606
74011641|NCT00807742|147574210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.29|TWO_SIDED|95.0|0.57|2.63|||Chi-squared|||||2.63|0.57|.290
74011642|NCT00807742|147574211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.32|TWO_SIDED|95.0|0.49|8.23|||Chi-squared|||||8.23|0.49|.32
74011643|NCT00807742|147574212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.298|TWO_SIDED|95.0|0.51|8.45|||Chi-squared|||||8.45|0.51|.298
74093841|NCT02944383|147738579|SUPERIORITY|||||||0.4126||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4126
74093842|NCT02944383|147738579|SUPERIORITY|||||||0.0095||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0095
74093843|NCT02944383|147738579|SUPERIORITY|||||||0.0172||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0172
74011644|NCT00807742|147574213|SUPERIORITY||Effect Size d|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||t-test, 2 sided|||||-0.27|-0.71|<.001
74011645|NCT00807742|147574214|SUPERIORITY||Effect Size d|-0.15||||0.199|TWO_SIDED|95.0|-0.38|0.08|||t-test, 2 sided|||||0.08|-0.38|.199
74011646|NCT00807742|147574215|SUPERIORITY||Effect Size d|-0.12||||0.148|TWO_SIDED|95.0|-0.57|0.33|||t-test, 2 sided|||||0.33|-.57|.148
74011647|NCT00807742|147574216|SUPERIORITY||Effect Size d|-0.15||||0.249|TWO_SIDED|95.0|-0.4|0.11|||t-test, 2 sided|||||0.11|-0.40|.249
74011648|NCT00807742|147574217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.402|TWO_SIDED|95.0|0.59|3.72|||Chi-squared|||||3.72|0.59|0.402
74011649|NCT00807742|147574218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.772|TWO_SIDED|95.0|0.49|1.7|||Chi-squared|||||1.70|0.49|.772
74011650|NCT00807742|147574219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.91|TWO_SIDED|95.0|0.6|1.77|||Chi-squared|||||1.77|0.60|.910
74011651|NCT00807742|147574220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.812|TWO_SIDED|95.0|0.54|1.62|||Chi-squared|||||1.62|0.54|.812
74011652|NCT00807742|147574221|SUPERIORITY||Odds Ratio (OR)|0.76||||0.49|TWO_SIDED|95.0|0.36|1.65|||Chi-squared|||||1.65|0.36|.490
74011653|NCT00807742|147574222|SUPERIORITY||Odds Ratio (OR)|1.19||||0.511|TWO_SIDED|95.0|0.67|2.06|||Chi-squared|||||2.06|0.67|.511
74011654|NCT00807742|147574223|SUPERIORITY||Odds Ratio (OR)|1.19||||0.499|TWO_SIDED|95.0|0.72|1.97|||Chi-squared|||||1.97|0.72|.499
74011655|NCT00807742|147574224|SUPERIORITY||Odds Ratio (OR)|0.96||||0.876|TWO_SIDED|95.0|0.58|1.6|||Chi-squared|||||1.60|0.58|.876
74011656|NCT00807742|147574225|SUPERIORITY_OR_OTHER||Effect Size d|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||t-test, 2 sided|||||-0.15|-0.59|.001
74011657|NCT00807742|147574226|SUPERIORITY_OR_OTHER||Effect Size d|-0.25||||0.069|TWO_SIDED|95.0|-0.46|0.02|||t-test, 2 sided|||||0.02|-0.46|.069
74093844|NCT02944383|147738579|SUPERIORITY||Median Difference (Net)|-23.23||||0.0359|TWO_SIDED|95.0|-41.54|-3.64||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-3.64|-41.54|0.0359
74093845|NCT02944383|147738579|SUPERIORITY||Median Difference (Net)|-16.06||||0.0812|TWO_SIDED|95.0|-38.62|5.61||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.61|-38.62|0.0812
74093846|NCT02944383|147738580|SUPERIORITY|||||||0.1362||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1362
74093847|NCT02944383|147738580|SUPERIORITY|||||||0.6458||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.6458
74093848|NCT02944383|147738580|SUPERIORITY|||||||0.0209||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0209
74093849|NCT02944383|147738580|SUPERIORITY|||||||0.0822||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0822
74093850|NCT02944383|147738580|SUPERIORITY|||||||0.0504||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0504
73879632|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.89||0.0022|TWO_SIDED|95.0|-9.56|-2.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.11|-9.56|0.0022
74093851|NCT02944383|147738580|SUPERIORITY|||||||0.1315||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1315
74093852|NCT02944383|147738581|SUPERIORITY|||||||0.0843||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0843
74093853|NCT02944383|147738581|SUPERIORITY|||||||0.3587||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3587
74093854|NCT02944383|147738581|SUPERIORITY||Median Difference (Net)|12.99||||0.0843|TWO_SIDED|95.0|-0.54|25.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||25.51|-0.54|0.0843
74093855|NCT02944383|147738581|SUPERIORITY||Median Difference (Net)|7.98||||0.3587|TWO_SIDED|95.0|-3.7|21.39||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||21.39|-3.70|0.3587
74093856|NCT02944383|147738582|SUPERIORITY|||||||0.0768||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0768
74093857|NCT02944383|147738582|SUPERIORITY|||||||0.4346||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4346
73887992|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0351|TWO_SIDED|95.0|0.2|6.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.3|0.2|0.0351
74011658|NCT00807742|147574227|SUPERIORITY_OR_OTHER||Effect Size d|-0.16||||0.202|TWO_SIDED|95.0|-0.4|0.08|||t-test, 2 sided|||||0.08|-0.40|.202
74011659|NCT00807742|147574228|SUPERIORITY_OR_OTHER||Effect Size d|-0.17||||0.199|TWO_SIDED|95.0|-0.42|0.09|||t-test, 2 sided|||||0.09|-0.42|.199
74011660|NCT00492752|147574229|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6783||||0.014144||95.0|0.4962|0.9272|||Log Rank||Hazard ratio is for Sorafenib vs placebo.|||0.9272|0.4962|0.014144
74011661|NCT00492752|147574229|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6208||||0.003464||95.0|0.4498|0.8568|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||0.8568|0.4498|0.003464
74011662|NCT00492752|147574230|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9032||||0.497537||95.0|0.6705|1.2165|||Log Rank||Hazard ratio is for Sorafenib vs placebo.|||1.2165|0.6705|0.497537
74011663|NCT00492752|147574230|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8831||||0.437926||95.0|0.6449|1.2093|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||1.2093|0.6449|0.437926
74011664|NCT00492752|147574231|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5744||||0.000537||95.0|0.4154|0.7942|||Log Rank||Hazard ratio is for Sorafenib vs placebo|||0.7942|0.4154|0.000537
74011665|NCT00492752|147574231|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5375||||0.00054||95.0|0.3763|0.7677|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||0.7677|0.3763|0.000540
74011666|NCT00492752|147574232|SUPERIORITY_OR_OTHER||Disease control rate|0.3533||||||95.0|0.2771|0.4355||||||||0.4355|0.2771|
74011667|NCT00492752|147574232|SUPERIORITY_OR_OTHER||Disease control rate|0.1579||||||95.0|0.0843|0.2596||||||||0.2596|0.0843|
74011668|NCT00492752|147574235|SUPERIORITY_OR_OTHER|||||||0.67|||||||Fisher Exact|based on tumor response rate (CR+PR)||||||0.67
74011669|NCT02012621|147574262|OTHER||Odds Ratio (OR)|73.5|||<|0.0001|TWO_SIDED|95.0|25.7|210.5|||Regression, Logistic|||||210.5|25.7|<0.0001
74011670|NCT02012621|147574263|OTHER||Odds Ratio (OR)|8.5||||0.0012|TWO_SIDED|95.0|2.3|30.9|||Regression, Logistic|||||30.9|2.3|0.0012
74011671|NCT02012621|147574264|OTHER||Odds Ratio (OR)|4.7|||<|0.0001|TWO_SIDED|95.0|2.6|8.7|||Regression, Logistic|||||8.7|2.6|<0.0001
74011672|NCT04722042|147574265|SUPERIORITY|||||||0.557|||||||ANOVA|||comparison of word recognition over time (activation, and 1, 3, 6, and 12 months post-activation) between groups (default versus place-based)||||0.557
74011673|NCT04722042|147574266|SUPERIORITY|||||||0.208|||||||ANOVA|||comparison of spatial release from masking over time (1, 3, 6, and 12 months post-activation) between the groups (default versus place-based)||||0.208
74011674|NCT04722042|147574267|SUPERIORITY|||||||0.126|||||||ANOVA|||comparison of spatial release from masking between the groups over time||||0.126
74011675|NCT04722042|147574268|SUPERIORITY|||||||0.369|||||||ANOVA|||comparison of perceived benefit between the groups over time||||0.369
74011676|NCT04722042|147574269|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
74011677|NCT04722042|147574270|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74011678|NCT04722042|147574271|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
74011679|NCT02090413|147574276|SUPERIORITY_OR_OTHER||Difference in percentage|2.4|||||TWO_SIDED|95.0|-6.4|11.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined||11.2|-6.4|
74011680|NCT02090413|147574276|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3|||||TWO_SIDED|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined||8.3|-10.8|
74011681|NCT02090413|147574276|SUPERIORITY_OR_OTHER||Difference in percentage|2.0|||||TWO_SIDED|95.0|-9.3|13.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1||13.2|-9.3|
74011682|NCT02090413|147574276|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-11.4|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1||11.4|-11.4|
74011683|NCT02090413|147574276|SUPERIORITY_OR_OTHER||Difference in percentage|-14.8|||||TWO_SIDED|95.0|-29.2|-0.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2||-0.3|-29.2|
74011684|NCT02090413|147574276|SUPERIORITY_OR_OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-20.9|6.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2||6.9|-20.9|
74011685|NCT02090413|147574276|SUPERIORITY_OR_OTHER||Difference in percentage|-17.6|||||TWO_SIDED|95.0|-32.8|-2.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3||-2.4|-32.8|
74011686|NCT02090413|147574276|SUPERIORITY_OR_OTHER||Difference in percentage|-19.0|||||TWO_SIDED|95.0|-34.1|-3.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3||-3.9|-34.1|
74011687|NCT02090413|147574276|SUPERIORITY_OR_OTHER||Difference in percentage|-4.8|||||TWO_SIDED|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4||11.4|-21.0|
74011688|NCT02090413|147574276|SUPERIORITY_OR_OTHER||Difference in percentage|-4.8|||||TWO_SIDED|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4||11.4|-21.0|
74011689|NCT02090413|147574277|SUPERIORITY_OR_OTHER||Difference in percentage|4.9|||||TWO_SIDED|95.0|-2.6|12.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events||12.4|-2.6|
74011690|NCT02090413|147574277|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-2.5|12.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events||12.5|-2.5|
74011691|NCT02090413|147574277|SUPERIORITY_OR_OTHER||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-11.2|8.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events||8.1|-11.2|
74011692|NCT02090413|147574277|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3|||||TWO_SIDED|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events||8.3|-10.8|
74093858|NCT02944383|147738582|SUPERIORITY|||||||0.0768||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0768
74093859|NCT02944383|147738582|SUPERIORITY|||||||0.4346||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.4346
74093860|NCT02944383|147738583|SUPERIORITY|||||||0.5411||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5411
74093861|NCT02944383|147738583|SUPERIORITY|||||||0.2574||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2574
74093862|NCT02944383|147738583|SUPERIORITY||Median Difference (Net)|3.11||||0.5411|TWO_SIDED|95.0|-9.59|14.86||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||14.86|-9.59|0.5411
74093863|NCT02944383|147738583|SUPERIORITY||Median Difference (Net)|-7.31||||0.2574|TWO_SIDED|95.0|-19.3|5.76||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.76|-19.30|0.2574
74093864|NCT02944383|147738584|SUPERIORITY|||||||0.3998||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3998
74093865|NCT02944383|147738584|SUPERIORITY|||||||0.3659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3659
73879633|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.87||0.0003|TWO_SIDED|95.0|-10.56|-3.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.19|-10.56|0.0003
74093866|NCT02944383|147738584|SUPERIORITY|||||||0.3998||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3998
74093867|NCT02944383|147738584|SUPERIORITY|||||||0.3659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3659
74093868|NCT02944383|147738585|SUPERIORITY|||||||0.8823||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8823
74093869|NCT02944383|147738585|SUPERIORITY|||||||0.3788||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.3788
74093870|NCT02944383|147738585|SUPERIORITY|||||||0.1091||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1091
74093871|NCT02944383|147738585|SUPERIORITY|||||||0.6867||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6867
74093872|NCT02944383|147738585|SUPERIORITY||Median Difference (Net)|9.07||||0.3156|TWO_SIDED|95.0|-12.22|36.34||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||36.34|-12.22|0.3156
74093873|NCT02944383|147738585|SUPERIORITY||Median Difference (Net)|-0.3||||0.9734|TWO_SIDED|95.0|-24.58|25.43||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||25.43|-24.58|0.9734
74093874|NCT02944383|147738586|SUPERIORITY|||||||0.9772||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9772
74093875|NCT02944383|147738586|SUPERIORITY|||||||0.5213||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5213
73879634|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|-9.44|-2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.13|-9.44|0.0020
73879635|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.82||0.0023|TWO_SIDED|95.0|-9.18|-2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.01|-9.18|0.0023
74011693|NCT02090413|147574277|SUPERIORITY_OR_OTHER||Difference in percentage|4.9|||||TWO_SIDED|95.0|-1.8|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events||11.7|-1.8|
74011694|NCT02090413|147574277|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-1.7|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events||11.7|-1.7|
74011695|NCT02090413|147574277|SUPERIORITY_OR_OTHER||Difference in percentage|5.9|||||TWO_SIDED|95.0|-5.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events||17.3|-5.4|
74093876|NCT02944383|147738586|SUPERIORITY|||||||0.1582||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1582
74093877|NCT02944383|147738586|SUPERIORITY|||||||0.4588||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4588
74093878|NCT02944383|147738586|SUPERIORITY|||||||0.4264||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.4264
74093879|NCT02944383|147738586|SUPERIORITY|||||||0.8107||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.8107
74011696|NCT02090413|147574277|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-6.4|16.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events||16.4|-6.4|
74011697|NCT02090413|147574277|SUPERIORITY_OR_OTHER||Difference in percentage|-8.0|||||TWO_SIDED|95.0|-19.5|3.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events||3.5|-19.5|
74011698|NCT02090413|147574277|SUPERIORITY_OR_OTHER||Difference in percentage|-11.3|||||TWO_SIDED|95.0|-23.1|0.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events||0.6|-23.1|
74011699|NCT02090413|147574280|SUPERIORITY_OR_OTHER||Difference in percentage|-1.4|||||TWO_SIDED|95.0|-15.8|13.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined||13.0|-15.8|
74011700|NCT02090413|147574280|SUPERIORITY_OR_OTHER||Difference in percentage|5.4|||||TWO_SIDED|95.0|-8.4|19.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined||19.1|-8.4|
73887993|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8751|TWO_SIDED|95.0|-3.3|2.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.8|-3.3|0.8751
74011701|NCT02090413|147574280|SUPERIORITY_OR_OTHER||Difference in percentage|6.5|||||TWO_SIDED|95.0|-9.9|23.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined||23.0|-9.9|
74011702|NCT02090413|147574280|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||||TWO_SIDED|95.0|0.2|31.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined||31.3|0.2|
74011703|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined||15.4|-10.2|
74011704|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-8.6|16.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined||16.6|-8.6|
74011705|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|3.1|||||TWO_SIDED|95.0|-12.8|18.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined||18.9|-12.8|
74011706|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|12.3|||||TWO_SIDED|95.0|-2.8|27.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined||27.3|-2.8|
74011707|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|-1.8|||||TWO_SIDED|95.0|-15.7|12.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined||12.2|-15.7|
74011708|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-9.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined||17.3|-9.4|
74093880|NCT02944383|147738587|SUPERIORITY||Odds Ratio (OR)|5.38||||0.0093|TWO_SIDED|95.0|1.51|19.08||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 10||19.08|1.51|0.0093
74093881|NCT02944383|147738587|SUPERIORITY||Odds Ratio (OR)|2.57||||0.107|TWO_SIDED|95.0|0.82|8.07||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 10||8.07|0.82|0.1070
74093882|NCT02944383|147738587|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0865|TWO_SIDED|95.0|0.87|7.53||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic|||Week 12||7.53|0.87|0.0865
73879636|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.82||0.0004|TWO_SIDED|95.0|-10.06|-2.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.89|-10.06|0.0004
74093883|NCT02944383|147738587|SUPERIORITY||Odds Ratio (OR)|1.57||||0.399|TWO_SIDED|95.0|0.55|4.48||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 12||4.48|0.55|0.3990
74093884|NCT02944383|147738587|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0772|TWO_SIDED|95.0|0.9|8.42||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|EOS (average of week 10 and 12)||8.42|0.90|0.0772
74093885|NCT02944383|147738587|SUPERIORITY||Odds Ratio (OR)|1.54||||0.4315|TWO_SIDED|95.0|0.53|4.48||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|EOS (average of week 10 and 12)||4.48|0.53|0.4315
74093886|NCT00364949|147738588|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||||||0.049
74011709|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-25.1|7.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined||7.0|-25.1|
74011710|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|3.3|||||TWO_SIDED|95.0|-12.0|18.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined||18.5|-12.0|
74011711|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|-0.3|||||TWO_SIDED|95.0|-13.5|12.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined||12.9|-13.5|
74011712|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined||15.4|-10.2|
74011713|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|0.2|||||TWO_SIDED|95.0|-15.3|15.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined||15.7|-15.3|
74011714|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|4.8|||||TWO_SIDED|95.0|-10.3|19.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined||19.9|-10.3|
74011715|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-18.4|14.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined||14.3|-18.4|
74011716|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|13.7|||||TWO_SIDED|95.0|-1.9|29.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined||29.3|-1.9|
74011717|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|-5.2|||||TWO_SIDED|95.0|-22.1|11.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined||11.8|-22.1|
73879637|NCT03192176|147297614|SUPERIORITY||LSMean difference|-7.4|STANDARD_ERROR_OF_MEAN|1.84|<|0.0001|TWO_SIDED|95.0|-11.05|-3.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.81|-11.05|<0.0001
74011718|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|7.1|||||TWO_SIDED|95.0|-9.6|23.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined||23.9|-9.6|
74011719|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|9.4|||||TWO_SIDED|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8 combined||25.5|-6.8|
74011720|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|9.4|||||TWO_SIDED|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8||25.5|-6.8|
74011721|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-13.2|20.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined||20.8|-13.2|
73879638|NCT03192176|147297614|SUPERIORITY||LSMean difference|-8.1|STANDARD_ERROR_OF_MEAN|1.86|<|0.0001|TWO_SIDED|95.0|-11.8|-4.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-4.49|-11.80|<0.0001
73879639|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.85||0.0011|TWO_SIDED|95.0|-9.77|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.47|-9.77|0.0011
74011722|NCT02090413|147574281|SUPERIORITY_OR_OTHER||Difference in percentage|8.4|||||TWO_SIDED|95.0|-8.5|25.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined||25.3|-8.5|
74011723|NCT02090413|147574285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.414|0.125|||||Analysis of variance model (ANCOVA) model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||0.125|-0.414|
74011724|NCT02090413|147574285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.392|||||TWO_SIDED|95.0|-0.656|-0.128|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||-0.128|-0.656|
74011725|NCT02090413|147574285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|||||TWO_SIDED|95.0|-0.507|0.012|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||0.012|-0.507|
74011726|NCT02090413|147574285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.376|||||TWO_SIDED|95.0|-0.193|0.945|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.945|-0.193|
74011727|NCT02090413|147574285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|||||TWO_SIDED|95.0|-0.498|0.635|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.635|-0.498|
74011728|NCT02090413|147574285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.308|||||TWO_SIDED|95.0|-0.867|0.251|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.251|-0.867|
74011729|NCT02090413|147574285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|||||TWO_SIDED|95.0|-0.308|0.355|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.355|-0.308|
74011730|NCT02090413|147574285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.374|0.254|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.254|-0.374|
74011731|NCT02090413|147574285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||||TWO_SIDED|95.0|-0.4|0.232|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.232|-0.4|
74011732|NCT00255970|147574301|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study had been designed as a superiority study. The null hypothesis had been that there would be no significant difference in probing depth between groups at the time points measured.||||>.05
74011733|NCT00255970|147574301|SUPERIORITY_OR_OTHER||||||>|0.05||||||The power analysis had been computed for a threshold of 0.05 with a power of 0.8.|ANOVA|||A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study.||||>0.05
74011734|NCT00255970|147574302|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>.05
74011735|NCT00255970|147574303|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The change in recession, measured in mm, had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>0.05
73879640|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0002|TWO_SIDED|95.0|-10.54|-3.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.32|-10.54|0.0002
73879641|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.82||0.0008|TWO_SIDED|95.0|-9.71|-2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.56|-9.71|0.0008
74011736|NCT00255970|147574304|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||Each gingival unit (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of the individual tooth will be given a score from 0-3, called the gingival index for the area. The scores from the 6 areas of the tooth are added and divided by 6 to give the gingival index for the tooth.||||>0.05
74011737|NCT00255970|147574305|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>0.05
74011738|NCT03577730|147574316|OTHER||Median Difference (Final Values)|55.0||||0.092|TWO_SIDED|95.0|-9.0|118.0|||Generalized estimating equations||The median difference (+55) is an estimated difference between groups - rather than the actual difference - based on the pre-specified generalized estimated equations modeling.|||118|-9|0.092
74011739|NCT03577730|147574317|OTHER|||||||0.802|||||||Mixed Models Analysis|||Analysis for visual analog scale scores at rest presented.||||0.802
74011740|NCT03577730|147574318|OTHER|||||||0.32|||||||Mixed Models Analysis|||||||0.320
74011741|NCT03577730|147574319|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.670
74011742|NCT03577730|147574320|OTHER|||||||0.595|||||||Fisher Exact|||||||0.595
74011743|NCT03577730|147574321|OTHER|||||||0.985|||||||Fisher Exact|||||||0.985
74042016|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.42|1.02||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.02|0.42|0.2670
74042017|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.62|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.62|0.5823
74042018|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7636|TWO_SIDED|95.0|0.65|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.65|0.7636
74042019|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.0422|TWO_SIDED|95.0|0.48|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.48|0.0422
74093887|NCT00364949|147738589|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||||||0.042
74093888|NCT00364949|147738590|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||t-test, 2 sided|||||||0.156
74093889|NCT00364949|147738591|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||t-test, 2 sided|||||||0.770
74093890|NCT00364949|147738592|SUPERIORITY_OR_OTHER|||||||0.325||95.0|||||t-test, 2 sided|||||||0.325
74093891|NCT04763564|147738595|SUPERIORITY||||||<|0.03||||||A priori threshold for significance was \< 0.05. Significance level liraglutide vs. placebo in percent reduction of bowel frequency at week 4 vs. baseline.|Mixed Models Analysis|||The 2 treatment modalities, Liraglutide and Placebo, were compared. A repeated-measures mixed model was fitted to the data, with treatment (liraglutide or placebo), period, and treatment sequence as fixed effects and the repeated measures within the subject as a random effect.||||<0.03
74093892|NCT04763564|147738598|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||The 2 treatment modalities, Liraglutide and Placebo, were compared. A repeated-measures mixed model was fitted to the data, with treatment (liraglutide or placebo), period, and treatment sequence as fixed effects and the repeated measures within the subject as a random effect.||||0.01
74093893|NCT00852969|147738645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.71|TWO_SIDED|95.0|-10.79|7.41|||t-test, 2 sided|||||7.41|-10.79|0.71
74093894|NCT00852969|147738646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.48||||0.29|TWO_SIDED|95.0|-7.2|2.24|||t-test, 2 sided|||||2.24|-7.20|0.29
74093895|NCT02358343|147738692|SUPERIORITY|||||||0.77||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood ratio test obtained from logistic regression analysis adjusting for site||||||0.77
74093896|NCT02358343|147738693|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.035|TWO_SIDED|95.0|-3.54|-0.13||a priori threshold for significance is 0.05.|Wald Test|The Wald test is for the week 12 comparative treatment effect from a longitudinal model of QIDS-C adjusting for clinical site.|The week 12 mean difference estimated from the longitudinal model is the difference between antidepressant drug therapy (drug) and the cognitive behavioral therapy (CBT) at 12 weeks, (drug - CBT).|All participants randomized to treatment (N=120) were included in the pre-specified longitudinal model of QIDS-C used to estimate comparative treatment effect at 12 weeks (primary outcome). The model adjustment for clinical site and included baseline, 6 week and 12 week QIDS-C scores. Week 0 (baseline) and week 6 measurements are not pre-specified primary or secondary outcomes. The Observational Cohort arm was not included in the analysis.||-0.13|-3.54|0.035
74011744|NCT03577730|147574322|OTHER|||||||0.417|||||||Wilcoxon (Mann-Whitney)|||||||0.417
74011745|NCT03577730|147574323|OTHER|||||||0.432|||||||Wilcoxon (Mann-Whitney)|||||||0.432
74011746|NCT03577730|147574324|OTHER|||||||0.673|||||||Wilcoxon (Mann-Whitney)|||||||0.673
74011747|NCT03577730|147574325|OTHER|||||||0.058|||||||Chi-squared|||||||0.058
74011748|NCT01911442|147574336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.15||0.5463|TWO_SIDED|95.0|-5.6|3.0|||Mixed Models Analysis|||LS Mean, LS mean difference and the associated 95% Cl and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||3.0|-5.6|0.5463
74011749|NCT01911442|147574336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|2.09||0.3592|TWO_SIDED|95.0|-6.1|2.2|||Mixed Models Analysis|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures.||2.2|-6.1|0.3592
74011750|NCT01911442|147574337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1755|TWO_SIDED||||||Mixed Models Analysis||This is due to rounding. the LSM for Lurasidone 20 mg/d at week 6 was -1.069 vs -0.734 for placebo group. So the LSM of the treatment difference between Lurasidone 20 mg/d and placebo was 0.335 if 3 decimals are reported.|||||0.1755
74011751|NCT01911442|147574337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2402|TWO_SIDED||||||Mixed Models Analysis|||||||0.2402
74011752|NCT00122681|147574343|SUPERIORITY_OR_OTHER||1-Rate Ratio|92.9|||||TWO_SIDED|95.0|79.9|98.3||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||98.3|79.9|
74011753|NCT00122681|147574343|SUPERIORITY_OR_OTHER||1-Rate Ratio|95.7|||||TWO_SIDED|95.0|82.9|99.6||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||99.6|82.9|
74042020|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.53|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.53|0.2670
74042021|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.8454|TWO_SIDED|95.0|0.72|1.78||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.78|0.72|0.8454
74042022|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.7636|TWO_SIDED|95.0|0.81|2.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.00|0.81|0.7636
74042023|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2824|TWO_SIDED|95.0|0.45|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.45|0.2824
74042024|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.5155|TWO_SIDED|95.0|0.83|2.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.06|0.83|0.5155
74042025|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.5823|TWO_SIDED|95.0|0.5|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.50|0.5823
74042026|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.7636|TWO_SIDED|95.0|0.78|1.7||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.70|0.78|0.7636
74042027|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.4644|TWO_SIDED|95.0|0.56|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.25|0.56|0.4644
74042028|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.59|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.59|0.8826
74042029|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.61|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.61|0.5823
74093897|NCT02358343|147738694|SUPERIORITY|||||||0.96||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood Ratio Test from logistic regression analysis adjusting for clinical site.||||||0.96
74093898|NCT02358343|147738695|SUPERIORITY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-7.4|-0.02|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||-0.02|-7.4|
74042030|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7636|TWO_SIDED|95.0|0.65|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.65|0.7636
74042031|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.3299|TWO_SIDED|95.0|0.6|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.60|0.3299
74093899|NCT02358343|147738696|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-3.1|0.8|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.8|-3.1|
73887994|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0795|TWO_SIDED|95.0|-0.3|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-0.3|0.0795
74042032|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.54|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.54|0.2670
74042033|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.48|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.48|0.5823
74042034|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.7907|TWO_SIDED|95.0|0.68|1.69||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.69|0.68|0.7907
74042035|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2742|TWO_SIDED|95.0|0.43|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.43|0.2742
74042036|NCT01392378|147635957|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.42|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.42|0.2670
74042037|NCT01392378|147635958|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.813|TWO_SIDED|95.0|0.71|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.71|0.813
74042038|NCT01392378|147635958|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.845|TWO_SIDED|95.0|0.79|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.34|0.79|0.845
74042039|NCT01392378|147635958|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.461|TWO_SIDED|95.0|0.65|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.65|0.461
74042040|NCT01392378|147635958|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.545|TWO_SIDED|95.0|0.68|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.68|0.545
73887995|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.8382|TWO_SIDED|95.0|-2.7|3.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.4|-2.7|0.8382
74042041|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.91||||0.712|TWO_SIDED|95.0|0.79|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.79|0.712
74042042|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.837|TWO_SIDED|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.84|0.837
74042043|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.357|TWO_SIDED|95.0|0.78|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.78|0.357
74042044|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.19|TWO_SIDED|95.0|0.76|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.76|0.190
74042045|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.813|TWO_SIDED|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.83|0.813
74042046|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.136|TWO_SIDED|95.0|0.73|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.73|0.136
74042047|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.104|TWO_SIDED|95.0|0.74|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.74|0.104
73879642|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|2.15||0.0054|TWO_SIDED|95.0|-10.26|-1.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.80|-10.26|0.0054
74042048|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.73|||<|0.001|TWO_SIDED|95.0|0.64|0.85||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.85|0.64|<0.001
74042049|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.712|TWO_SIDED|95.0|0.72|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.72|0.712
74042050|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.206|TWO_SIDED|95.0|0.7|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.70|0.206
74042051|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.78||||0.066|TWO_SIDED|95.0|0.65|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.93|0.65|0.066
74042052|NCT01392378|147635959|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.085|TWO_SIDED|95.0|0.67|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.97|0.67|0.085
74042053|NCT01392378|147635960|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.712|TWO_SIDED|95.0|0.77|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.77|0.712
74042054|NCT01392378|147635960|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.206|TWO_SIDED|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.74|0.206
74042055|NCT01392378|147635960|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.104|TWO_SIDED|95.0|0.72|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.72|0.104
74042056|NCT01392378|147635960|SUPERIORITY_OR_OTHER||GMC Ratio|0.74||||0.001|TWO_SIDED|95.0|0.63|0.87||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.87|0.63|0.001
74042057|NCT01392378|147635960|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.813|TWO_SIDED|95.0|0.82|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.82|0.813
74042058|NCT01392378|147635960|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.837|TWO_SIDED|95.0|0.9|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.90|0.837
74042059|NCT01392378|147635960|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.534|TWO_SIDED|95.0|0.81|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.81|0.534
74042060|NCT01392378|147635960|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.961|TWO_SIDED|95.0|0.87|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.87|0.961
74042061|NCT01392378|147635961|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.85|TWO_SIDED|95.0|0.75|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.42|0.75|0.850
73879643|NCT03192176|147297614|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.15||0.1145|TWO_SIDED|95.0|-7.63|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.83|-7.63|0.1145
74011754|NCT00122681|147574343|SUPERIORITY_OR_OTHER||1-Rate Ratio|86.7|||||TWO_SIDED|95.0|39.7|98.7||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||98.7|39.7|
73879644|NCT03192176|147297614|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.21||0.2106|TWO_SIDED|95.0|-7.13|1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.58|-7.13|0.2106
74011755|NCT00122681|147574343|SUPERIORITY_OR_OTHER||1-Rate Ratio|90.8|||||TWO_SIDED|95.0|78.1|96.9||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||96.9|78.1|
74011756|NCT00122681|147574343|SUPERIORITY_OR_OTHER||1-Rate Ratio|92.7|||||TWO_SIDED|95.0|79.3|98.2||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.2|79.3|
74011757|NCT00122681|147574343|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.6|||||TWO_SIDED|95.0|44.1|98.8||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.8|44.1|
74011758|NCT00122681|147574344|SUPERIORITY_OR_OTHER||1-Rate Ratio|94.9|||||TWO_SIDED|95.0|87.7|98.4||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed||98.4|87.7|
74011759|NCT00122681|147574344|SUPERIORITY_OR_OTHER||1-Rate Ratio|97.6|||||TWO_SIDED|95.0|91.0|99.7||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed||99.7|91.0|
74011760|NCT00122681|147574344|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.1|||||TWO_SIDED|95.0|57.2|97.5||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||97.5|57.2|
74011761|NCT00122681|147574344|SUPERIORITY_OR_OTHER||1-Rate Ratio|93.6|||||TWO_SIDED|95.0|86.3|97.5||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||97.5|86.3|
74042062|NCT01392378|147635961|SUPERIORITY_OR_OTHER||GMC Ratio|1.05||||0.837|TWO_SIDED|95.0|0.77|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.44|0.77|0.837
73879645|NCT03192176|147297614|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|2.21||0.0685|TWO_SIDED|95.0|-8.39|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.31|-8.39|0.0685
74011762|NCT00122681|147574344|SUPERIORITY_OR_OTHER||1-Rate Ratio|95.7|||||TWO_SIDED|95.0|88.5|98.9||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.9|88.5|
73879646|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|2.22||0.0029|TWO_SIDED|95.0|-11.02|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-2.29|-11.02|0.0029
73879647|NCT03192176|147297614|SUPERIORITY||LSMean difference|-5.0|STANDARD_ERROR_OF_MEAN|2.22||0.0239|TWO_SIDED|95.0|-9.42|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.67|-9.42|0.0239
73879648|NCT03192176|147297614|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.15||0.2224|TWO_SIDED|95.0|-6.86|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.60|-6.86|0.2224
73879649|NCT03192176|147297614|SUPERIORITY||LSMean differencce|-4.8|STANDARD_ERROR_OF_MEAN|2.22||0.0308|TWO_SIDED|95.0|-9.17|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.45|-9.17|0.0308
73879650|NCT03192176|147297614|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|2.21||0.4194|TWO_SIDED|95.0|-6.13|2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.56|-6.13|0.4194
73879651|NCT03192176|147297614|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.29||0.3759|TWO_SIDED|95.0|-6.55|2.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.48|-6.55|0.3759
73879652|NCT03192176|147297614|SUPERIORITY||LSMean differencce|-2.8|STANDARD_ERROR_OF_MEAN|2.29||0.2285|TWO_SIDED|95.0|-7.26|1.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.74|-7.26|0.2285
73879653|NCT03192176|147297614|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|2.29||0.0072|TWO_SIDED|95.0|-10.71|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-1.70|-10.71|0.0072
73879654|NCT03192176|147297614|SUPERIORITY||LSMean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.31||0.0338|TWO_SIDED|95.0|-9.46|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.38|-9.46|0.0338
73879655|NCT03192176|147297614|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.21||0.3026|TWO_SIDED|95.0|-6.64|2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.07|-6.64|0.3026
73879656|NCT03192176|147297614|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.16||0.312|TWO_SIDED|95.0|-6.45|2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.07|-6.45|0.3120
73879657|NCT03192176|147297614|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|2.15||0.6816|TWO_SIDED|95.0|-5.11|3.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||3.34|-5.11|0.6816
73879658|NCT03192176|147297614|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|2.26||0.8599|TWO_SIDED|95.0|-4.85|4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.05|-4.85|0.8599
73879659|NCT03192176|147297614|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.23||0.9093|TWO_SIDED|95.0|-4.64|4.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.13|-4.64|0.9093
74011763|NCT00122681|147574344|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.6|||||TWO_SIDED|95.0|59.2|97.6||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||97.6|59.2|
74011764|NCT00122681|147574369|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.798||||0.391|TWO_SIDED|95.0|0.476|1.337|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection||1.337|0.476|0.3910
74011765|NCT00122681|147574371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.778||||0.3796|TWO_SIDED|95.0|0.444|1.362|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.||1.362|0.444|0.3796
74011766|NCT00122681|147574373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.1035||95.0|0.337|1.106|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection.||1.106|0.337|0.1035
74011767|NCT00122681|147574375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.635||||0.2111|TWO_SIDED|95.0|0.312|1.293|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.||1.293|0.312|0.2111
74011768|NCT04416555|147574411|SUPERIORITY|||||||0.391|||||||Mixed Models Analysis|||||||0.391
74011769|NCT04416555|147574412|SUPERIORITY|||||||0.608|||||||Regression, Linear|||||||0.608
74011770|NCT04416555|147574413|SUPERIORITY|||||||0.768|||||||Mixed Models Analysis|||||||0.768
74011771|NCT04416555|147574414|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
74011772|NCT04416555|147574415|SUPERIORITY|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
74011773|NCT01118273|147574421|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANCOVA|||||||0.54
74011774|NCT01118273|147574422|SUPERIORITY_OR_OTHER|||||||0.31|||||||ANCOVA|||||||0.31
74011775|NCT01118273|147574423|SUPERIORITY_OR_OTHER|||||||0.45|||||||Log Rank|||||||0.45
74011776|NCT01118273|147574424|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
74042063|NCT01392378|147635961|SUPERIORITY_OR_OTHER||GMC Ratio|0.94||||0.695|TWO_SIDED|95.0|0.69|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.69|0.695
74042064|NCT01392378|147635961|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.408|TWO_SIDED|95.0|0.6|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.60|0.408
74042065|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.813|TWO_SIDED|95.0|0.69|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.69|0.813
74011777|NCT01118273|147574425|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|||||||0.05
74011778|NCT01118273|147574426|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|||||||0.019
74011779|NCT01118273|147574427|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANCOVA|||||||0.018
74011780|NCT01118273|147574428|SUPERIORITY_OR_OTHER|||||||0.03|||||||Cochran-Mantel-Haenszel|||||||0.03
74011781|NCT01118273|147574429|SUPERIORITY_OR_OTHER|||||||0.76|||||||Cochran-Mantel-Haenszel|||||||0.76
74011782|NCT01118273|147574430|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.015
74011783|NCT01118273|147574431|SUPERIORITY_OR_OTHER|||||||0.04|||||||Cochran-Mantel-Haenszel|||||||0.04
74011784|NCT01118273|147574432|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
74011785|NCT01118273|147574433|SUPERIORITY_OR_OTHER|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
74011786|NCT01118273|147574435|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANCOVA|||||||0.42
74011787|NCT01118273|147574436|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
74011788|NCT01118273|147574437|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
74011789|NCT01118273|147574438|SUPERIORITY_OR_OTHER|||||||0.72|||||||ANCOVA|||||||0.72
74011790|NCT01118273|147574439|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
74011791|NCT01118273|147574441|SUPERIORITY_OR_OTHER|||||||0.35|||||||Cochran-Mantel-Haenszel|||||||0.35
74011792|NCT01118273|147574443|SUPERIORITY_OR_OTHER|||||||0.53|||||||ANCOVA|||||||0.53
74011793|NCT01118273|147574444|SUPERIORITY_OR_OTHER|||||||0.55|||||||ANCOVA|||||||0.55
74011794|NCT01118273|147574445|SUPERIORITY_OR_OTHER|||||||0.59|||||||ANCOVA|||||||0.59
74011795|NCT01118273|147574446|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANCOVA|||||||0.25
74011796|NCT00552175|147574477|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.17|-0.56|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|The primary objective and primary efficacy analysis for the study was the analysis between the combined duloxetine arms and placebo.||-0.56|-1.17|<0.0001
74011797|NCT00552175|147574479|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.64||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.64|-1.27|<0.0001
74011798|NCT00552175|147574479|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.51||P-value for Night Pain.|Mixed Models Analysis|Covariates: Baseline value of night pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.51|-1.15|<0.0001
74011799|NCT00552175|147574480|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||||TWO_SIDED|95.0|-1.26|-0.49|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis||-0.49|-1.26|
74011800|NCT00552175|147574480|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.05|||||TWO_SIDED|95.0|-1.43|-0.66|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis||-0.66|-1.43|
74011801|NCT00552175|147574480|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78|||||TWO_SIDED|95.0|-1.17|-0.39|||Mixed Models Analysis|Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis||-0.39|-1.17|
74042066|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|0.92||||0.837|TWO_SIDED|95.0|0.68|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.25|0.68|0.837
74011802|NCT00552175|147574480|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.89|||||TWO_SIDED|95.0|-1.28|-0.5|||Mixed Models Analysis|Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis||-0.5|-1.28|
74011803|NCT00552175|147574481|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.85|-0.44|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.44|-0.85|<0.0001
74093900|NCT02358343|147738697|SUPERIORITY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-6.2|-0.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||-0.1|-6.2|
74011804|NCT00552175|147574482|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||||TWO_SIDED|95.0|-0.9|-0.39|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.39|-0.9|
74093901|NCT02358343|147738698|SUPERIORITY||Mean Difference (Final Values)|10.2|||||TWO_SIDED|95.0|1.3|19.0|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||19.0|1.3|
74093902|NCT02358343|147738699|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.2|1.4|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||1.4|-0.2|
74011805|NCT00552175|147574482|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||||TWO_SIDED|95.0|-0.91|-0.4|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.4|-0.91|
74011806|NCT00552175|147574483|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.61||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.61|-1.34|<0.0001
74011807|NCT00552175|147574483|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.48||P-value for Least Pain.|Mixed Models Analysis|Covariates: Baseline value of least pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.48|-1.21|<0.0001
74011808|NCT00552175|147574483|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.67||P-value for Average Pain.|Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.67|-1.33|<0.0001
74011809|NCT00552175|147574483|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.54||P-value for Pain Right Now.|Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.54|-1.29|<0.0001
74011810|NCT00552175|147574484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.89|||||TWO_SIDED|95.0|-1.34|-0.44|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis||-0.44|-1.34|
74011811|NCT00552175|147574484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.06|||||TWO_SIDED|95.0|-1.51|-0.62|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis||-0.62|-1.51|
74011812|NCT00552175|147574484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78|||||TWO_SIDED|95.0|-1.23|-0.33|||Mixed Models Analysis|Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis||-0.33|-1.23|
74011813|NCT00552175|147574484|SUPERIORITY_OR_OTHER||Least Mean Squares Difference|-0.91|||||TWO_SIDED|95.0|-1.36|-0.46|||Mixed Models Analysis|Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis||-0.46|-1.36|
74011814|NCT00552175|147574484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|||||TWO_SIDED|95.0|-1.39|-0.58|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis||-0.58|-1.39|
74011815|NCT00552175|147574484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.01|||||TWO_SIDED|95.0|-1.41|-0.61|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis||-0.61|-1.41|
74011816|NCT00552175|147574484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|||||TWO_SIDED|95.0|-1.35|-0.41|||Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis||-0.41|-1.35|
74011817|NCT00552175|147574484|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||||TWO_SIDED|95.0|-1.41|-0.48|||Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis||-0.48|-1.41|
74042067|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|0.94||||0.695|TWO_SIDED|95.0|0.68|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.68|0.695
74042068|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.961|TWO_SIDED|95.0|0.71|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.36|0.71|0.961
74042069|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|1.18||||0.808|TWO_SIDED|95.0|0.85|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.65|0.85|0.808
74042070|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|1.09||||0.837|TWO_SIDED|95.0|0.8|1.5||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.50|0.80|0.837
74042071|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|0.92||||0.695|TWO_SIDED|95.0|0.66|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.66|0.695
74042072|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|0.82||||0.408|TWO_SIDED|95.0|0.58|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.58|0.408
74042073|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|1.07||||0.813|TWO_SIDED|95.0|0.78|1.46||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.46|0.78|0.813
74042074|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.343|TWO_SIDED|95.0|0.59|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.59|0.343
74042075|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|1.12||||0.695|TWO_SIDED|95.0|0.82|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.82|0.695
74093903|NCT02358343|147738700|SUPERIORITY||Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0|0.1|5.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||5.1|0.1|
74093904|NCT02358343|147738701|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.5|0.5|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.5|-0.5|
74042076|NCT01392378|147635962|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.925|TWO_SIDED|95.0|0.69|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.69|0.925
74042077|NCT01392378|147635963|SUPERIORITY_OR_OTHER||GMC Ratio|1.08||||0.91|TWO_SIDED|95.0|0.81|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.81|0.910
74042078|NCT01392378|147635963|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.85|TWO_SIDED|95.0|0.79|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.79|0.850
74093905|NCT02358343|147738703|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.5|0.7|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.7|-0.5|
74011818|NCT00552175|147574485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41||||0.0676|TWO_SIDED|95.0|-0.85|0.03||P-value for General Activity.|Mixed Models Analysis|Covariates: Baseline value of general activity score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.03|-0.85|0.0676
74011819|NCT00552175|147574485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.37||||0.0933|TWO_SIDED|95.0|-0.8|0.06||P-value for Mood.|Mixed Models Analysis|Covariates: Baseline value of mood score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.06|-0.8|0.0933
74011820|NCT00552175|147574485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49||||0.0228|TWO_SIDED|95.0|-0.91|-0.07||P-value for Walking Ability.|Mixed Models Analysis|Covariates: Baseline value of walking ability score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.07|-0.91|0.0228
74011821|NCT00552175|147574485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.38||||0.0783|TWO_SIDED|95.0|-0.8|0.04||P-value for Normal Work.|Mixed Models Analysis|Covariates: Baseline value of normal work score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.04|-0.8|0.0783
74011822|NCT00552175|147574485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55||||0.0076|TWO_SIDED|95.0|-0.96|-0.15||P-value for Relation to People.|Mixed Models Analysis|Covariates: Baseline value of relation to people score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.15|-0.96|0.0076
74011823|NCT00552175|147574485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.46||||0.0378|TWO_SIDED|95.0|-0.9|-0.03||P-value for Sleep.|Mixed Models Analysis|Covariates: Baseline value of sleep score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.03|-0.9|0.0378
74011824|NCT00552175|147574485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56||||0.0089|TWO_SIDED|95.0|-0.98|-0.14||P-value for Enjoyment of Life.|Mixed Models Analysis|Covariates: Baseline value of enjoyment of life score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.14|-0.98|0.0089
74011825|NCT00552175|147574485|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48||||0.0095|TWO_SIDED|95.0|-0.85|-0.12||P-value for Average of Interference Scores|Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.12|-0.85|0.0095
74011826|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.14|-0.06|||Mixed Models Analysis|Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis||-0.06|-1.14|
74042079|NCT01392378|147635963|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.868|TWO_SIDED|95.0|0.7|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.70|0.868
74011827|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.77|0.32|||Mixed Models Analysis|Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis||0.32|-0.77|
74042080|NCT01392378|147635963|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.914|TWO_SIDED|95.0|0.67|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.67|0.914
74093906|NCT02358343|147738704|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.55|1.1|||||The mean difference estimate is from a negative binomial model adjusted for clinical site. It is the rate of sessions skipped/shortened in the Drug group (numerator) compared to CBT (denominator).|||1.10|0.55|
74093907|NCT02358343|147738705|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.54|0.34|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.34|-0.54|
74011828|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.8|0.27|||Mixed Models Analysis|Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis||0.27|-0.8|
74011829|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48|||||TWO_SIDED|95.0|-1.01|0.05|||Mixed Models Analysis|Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis||0.05|-1.01|
74011830|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.02|0.02|||Mixed Models Analysis|Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis||0.02|-1.02|
74011831|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49|||||TWO_SIDED|95.0|-1.01|0.03|||Mixed Models Analysis|Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis||0.03|-1.01|
74093908|NCT02358343|147738706|SUPERIORITY||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.25|0.75|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.75|-0.25|
74093909|NCT00807248|147738716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.96||0.6405|TWO_SIDED|95.0|-2.34|1.44|||ANCOVA|||||1.44|-2.34|0.6405
74093910|NCT00807248|147738716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.96||0.6227|TWO_SIDED|95.0|-1.41|2.35|||ANCOVA|||||2.35|-1.41|0.6227
74093911|NCT00807248|147738717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-7.98|-3.11|||ANCOVA|||||-3.11|-7.98|<0.0001
74011832|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.35|||||TWO_SIDED|95.0|-0.86|0.16|||Mixed Models Analysis|Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis||0.16|-0.86|
74011833|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|||||TWO_SIDED|95.0|-0.92|0.11|||Mixed Models Analysis|Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis||0.11|-0.92|
74011834|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.39|||||TWO_SIDED|95.0|-0.89|0.11|||Mixed Models Analysis|Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis||0.11|-0.89|
74042081|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|1.05||||0.91|TWO_SIDED|95.0|0.89|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.89|0.910
74042082|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.85|TWO_SIDED|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.89|0.850
74042083|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.961|TWO_SIDED|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.85|0.961
74042084|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.916|TWO_SIDED|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.85|0.916
74042085|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.91|TWO_SIDED|95.0|0.87|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.87|0.910
74042086|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|1.01||||0.909|TWO_SIDED|95.0|0.89|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.89|0.909
74042087|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.868|TWO_SIDED|95.0|0.93|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.93|0.868
74042088|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.914|TWO_SIDED|95.0|0.81|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.81|0.914
74042089|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.91|TWO_SIDED|95.0|0.76|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.76|0.910
74042090|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|0.91||||0.85|TWO_SIDED|95.0|0.76|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.76|0.850
74042091|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.868|TWO_SIDED|95.0|0.78|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.78|0.868
74042092|NCT01392378|147635964|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.914|TWO_SIDED|95.0|0.76|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.76|0.914
74093912|NCT00807248|147738717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-7.53|-2.66|||ANCOVA|||||-2.66|-7.53|<0.0001
74093913|NCT00807248|147738717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-8.43|-3.56|||ANCOVA|||||-3.56|-8.43|<0.0001
74093914|NCT00807248|147738718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.98|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.13|-2.84|||ANCOVA|||||-2.84|-7.13|<0.0001
74093915|NCT00807248|147738718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-6.6|-2.32|||ANCOVA|||||-2.32|-6.60|<0.0001
74093916|NCT00807248|147738718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.27|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.41|-3.13|||ANCOVA|||||-3.13|-7.41|<0.0001
74093917|NCT00807248|147738719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-4.59|-1.58|||ANCOVA|||||-1.58|-4.59|<0.0001
74042093|NCT01392378|147635965|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.91|TWO_SIDED|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.83|0.910
74042094|NCT01392378|147635965|SUPERIORITY_OR_OTHER||GMC Ratio|0.94||||0.85|TWO_SIDED|95.0|0.82|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.82|0.850
74042095|NCT01392378|147635965|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.939|TWO_SIDED|95.0|0.86|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.86|0.939
74042096|NCT01392378|147635965|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.279|TWO_SIDED|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.75|0.279
74042097|NCT01392378|147635965|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.149|TWO_SIDED|95.0|0.76|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.97|0.76|0.149
74042098|NCT01392378|147635965|SUPERIORITY_OR_OTHER||GMC Ratio|1.02||||0.85|TWO_SIDED|95.0|0.91|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.91|0.850
74042099|NCT01392378|147635965|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.394|TWO_SIDED|95.0|0.79|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.99|0.79|0.394
74042100|NCT01392378|147635965|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.916|TWO_SIDED|95.0|0.87|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.87|0.916
74042101|NCT01392378|147635966|SUPERIORITY_OR_OTHER||GMC Ratio|1.26||||0.869|TWO_SIDED|95.0|0.9|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.76|0.90|0.869
74042102|NCT01392378|147635966|SUPERIORITY_OR_OTHER||GMC Ratio|1.07||||0.85|TWO_SIDED|95.0|0.78|1.48||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.48|0.78|0.850
74042103|NCT01392378|147635966|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.868|TWO_SIDED|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.80|0.868
74093918|NCT00807248|147738719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.15|-1.14|||ANCOVA|||||-1.14|-4.15|0.0006
74042104|NCT01392378|147635966|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.916|TWO_SIDED|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.80|0.916
74093919|NCT00807248|147738719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-5.13|-2.1|||ANCOVA|||||-2.10|-5.13|<0.0001
74093920|NCT00807248|147738720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-1.85|-0.64|||ANCOVA|||||-0.64|-1.85|<0.0001
74093921|NCT00807248|147738720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|0.31||0.0004|TWO_SIDED|95.0|-1.72|-0.5|||ANCOVA|||||-0.50|-1.72|0.0004
74042105|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.91|TWO_SIDED|95.0|0.78|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.78|0.910
74093922|NCT00807248|147738720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-1.87|-0.65|||ANCOVA|||||-0.65|-1.87|<0.0001
74093923|NCT00807248|147738721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.32||0.0007|TWO_SIDED|95.0|-1.72|-0.46|||ANCOVA|||||-0.46|-1.72|0.0007
74093924|NCT00807248|147738721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.33||0.0013|TWO_SIDED|95.0|-1.69|-0.41|||ANCOVA|||||-0.41|-1.69|0.0013
74093925|NCT00807248|147738721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-1.92|-0.66|||ANCOVA|||||-0.66|-1.92|<0.0001
74042106|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|1.05||||0.85|TWO_SIDED|95.0|0.83|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.83|0.850
74042107|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|1.09||||0.868|TWO_SIDED|95.0|0.87|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.87|0.868
74042108|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|1.02||||0.916|TWO_SIDED|95.0|0.81|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.81|0.916
74042109|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|0.99||||0.91|TWO_SIDED|95.0|0.79|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.79|0.910
74042110|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|0.94||||0.85|TWO_SIDED|95.0|0.76|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.76|0.850
74042111|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.868|TWO_SIDED|95.0|0.77|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.77|0.868
74042112|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.916|TWO_SIDED|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.79|0.916
74042113|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|0.97||||0.91|TWO_SIDED|95.0|0.77|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.77|0.910
74042114|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|0.84||||0.85|TWO_SIDED|95.0|0.67|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.67|0.850
74042115|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.939|TWO_SIDED|95.0|0.78|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.78|0.939
73879660|NCT03192176|147297614|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|2.26||0.0788|TWO_SIDED|95.0|-8.43|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.46|-8.43|0.0788
74042116|NCT01392378|147635967|SUPERIORITY_OR_OTHER||GMT Ratio|0.96||||0.916|TWO_SIDED|95.0|0.76|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.76|0.916
74042117|NCT02713789|147635980|SUPERIORITY|||||||0.827|||||||ANCOVA|||SEP2||||0.827
74042118|NCT02713789|147635980|SUPERIORITY|||||||0.594|||||||ANCOVA|||SEP2||||0.594
74042119|NCT02713789|147635980|SUPERIORITY|||||||0.274|||||||ANCOVA|||SEP3||||0.274
73879661|NCT03192176|147297614|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|2.26||0.1278|TWO_SIDED|95.0|-7.92|1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.00|-7.92|0.1278
73879662|NCT03192176|147297614|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|2.15||0.9848|TWO_SIDED|95.0|-4.19|4.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.27|-4.19|0.9848
74042120|NCT02713789|147635980|SUPERIORITY|||||||0.766|||||||ANCOVA|||SEP3||||0.766
74042121|NCT02713789|147635981|SUPERIORITY|||||||0.384|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.384
74042122|NCT02713789|147635981|SUPERIORITY|||||||0.144|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.144
74042123|NCT02713789|147635981|SUPERIORITY|||||||0.022|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.022
74042124|NCT02713789|147635981|SUPERIORITY|||||||0.137|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.137
74093926|NCT00807248|147738722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.31||0.0002|TWO_SIDED|95.0|-1.82|-0.58|||ANCOVA|||||-0.58|-1.82|0.0002
74093927|NCT00807248|147738722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.32||0.0006|TWO_SIDED|95.0|-1.72|-0.48|||ANCOVA|||||-0.48|-1.72|0.0006
74093928|NCT00807248|147738722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.0|-0.76|||ANCOVA|||||-0.76|-2.00|<0.0001
74093929|NCT00807248|147738723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.89|-0.34|||ANCOVA|||||-0.34|-0.89|<0.0001
74093930|NCT00807248|147738723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.82|-0.26|||ANCOVA|||||-0.26|-0.82|0.0001
74093931|NCT00807248|147738723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.99|-0.44|||ANCOVA|||||-0.44|-0.99|<0.0001
74093932|NCT00807248|147738724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.02|-0.5|||ANCOVA|||||-0.50|-1.02|<0.0001
74093933|NCT00807248|147738724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.88|-0.36|||ANCOVA|||||-0.36|-0.88|<0.0001
74093934|NCT00807248|147738724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.97|-0.45|||ANCOVA|||||-0.45|-0.97|<0.0001
74093935|NCT01340768|147738831|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.52||||0.028|TWO_SIDED|95.0|0.29|0.94||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel|||||0.94|0.29|0.028
74093936|NCT01340768|147738832|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.006|TWO_SIDED|95.0|0.29|0.83||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel|||||0.83|0.29|0.006
74093937|NCT00655876|147738855|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.47|TWO_SIDED|95.0|0.7|1.16|||Log Rank|||The sample size was based on the primary hypothesis of a 29% reduction in the hazard rate of death with cetuximab, corresponding to an increase in 2-year overall survival (OS) from 41% to 53% and a hazard ratio (λ\[exp\]/λ\[cont\]) of 0.71 in favor of the cetuximab arm. Assuming an exponential distribution and constant hazards, 400 patients were required to reach 281 OS events, with 80% statistical power, a 1-sided α of 0.025, 4.5 years of accrual, 2 years of follow-up, and 4 interim analyses.||1.16|0.70|0.47
74042125|NCT02713789|147635981|SUPERIORITY|||||||0.123|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.123
74042126|NCT02713789|147635982|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.160
74042127|NCT02713789|147635982|SUPERIORITY|||||||0.208|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.208
74042128|NCT02713789|147635982|SUPERIORITY|||||||0.316|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.316
74042129|NCT02713789|147635982|SUPERIORITY|||||||0.221|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.221
74042130|NCT02713789|147635982|SUPERIORITY|||||||0.172|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.172
74042131|NCT02713789|147635983|SUPERIORITY|||||||0.199|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.199
74042132|NCT02713789|147635983|SUPERIORITY|||||||0.203|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.203
74042133|NCT02713789|147635983|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.500
74042134|NCT02713789|147635983|SUPERIORITY|||||||0.296|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.296
74042135|NCT02713789|147635983|SUPERIORITY|||||||0.286|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.286
74042136|NCT02713789|147635984|SUPERIORITY|||||||0.449|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.449
74042137|NCT02713789|147635984|SUPERIORITY|||||||0.381|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.381
74042138|NCT02713789|147635984|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.011
74042139|NCT02713789|147635984|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.05
74042140|NCT02713789|147635984|SUPERIORITY|||||||0.09|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.09
74042141|NCT02713789|147635985|SUPERIORITY|||||||0.074|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.074
74042142|NCT02713789|147635985|SUPERIORITY|||||||0.468|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.468
74042143|NCT02713789|147635985|SUPERIORITY|||||||0.109|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.109
74042144|NCT02713789|147635985|SUPERIORITY|||||||0.493|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.493
74042145|NCT02713789|147635985|SUPERIORITY|||||||0.235|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.235
74042146|NCT02713789|147635986|SUPERIORITY|||||||0.136|||||||ANCOVA|||SEP1||||0.136
74042147|NCT02713789|147635986|SUPERIORITY|||||||0.498|||||||ANCOVA|||SEP1||||0.498
74042148|NCT02713789|147635986|SUPERIORITY|||||||0.369|||||||ANCOVA|||SEP4||||0.369
74042149|NCT02713789|147635986|SUPERIORITY|||||||0.337|||||||ANCOVA|||SEP4||||0.337
74042150|NCT02713789|147635986|SUPERIORITY|||||||0.16|||||||ANCOVA|||SEP5||||0.160
74042151|NCT00014911|147635987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.0|||||TWO_SIDED|95.0|30.0|61.0|||Fisher Exact|||||61|30|
74042152|NCT00014911|147635988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.0|||||TWO_SIDED|95.0|16.0|44.0|||Fisher Exact|||||44|16|
74042153|NCT00014911|147635989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|58.0|||||TWO_SIDED|95.0|42.0|63.0|||Fisher Exact|||||63|42|
74093938|NCT00655876|147738856|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.65|TWO_SIDED|95.0|0.66|1.28|||Log Rank|One-sided significance level = 0.025||||1.28|0.66|0.65
74093939|NCT00655876|147738858|SUPERIORITY|||||||0.66|||||||Fisher Exact|One-sided significance level = 0.025||||||0.66
73879663|NCT03192176|147297615|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|7.05||0.0388|TWO_SIDED|95.0|0.76|28.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||28.49|0.76|0.0388
73879664|NCT03192176|147297615|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|7.08||0.0012|TWO_SIDED|95.0|9.17|37.02||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||37.02|9.17|0.0012
73879665|NCT03192176|147297615|SUPERIORITY||LSMean difference|37.3|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|23.41|51.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||51.22|23.41|<0.0001
73879666|NCT03192176|147297615|SUPERIORITY||LSMean difference|41.0|STANDARD_ERROR_OF_MEAN|7.16|<|0.0001|TWO_SIDED|95.0|26.88|55.05||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||55.05|26.88|<0.0001
74011835|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.71|||||TWO_SIDED|95.0|-1.21|-0.22|||Mixed Models Analysis|Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis||-0.22|-1.21|
73879667|NCT03192176|147297615|SUPERIORITY||LSMean difference|8.2|STANDARD_ERROR_OF_MEAN|7.19||0.2569|TWO_SIDED|95.0|-5.98|22.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||22.32|-5.98|0.2569
74011836|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.57|||||TWO_SIDED|95.0|-1.11|-0.03|||Mixed Models Analysis|Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis||-0.03|-1.11|
74093940|NCT00655876|147738859|SUPERIORITY|||||||0.04|||||||Chi-squared|Two-sided significance level = 0.05||6-8 weeks post-treatment||||0.04
73879668|NCT03192176|147297615|SUPERIORITY||LSMean difference|25.6|STANDARD_ERROR_OF_MEAN|7.07||0.0003|TWO_SIDED|95.0|11.65|39.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||39.47|11.65|0.0003
73879669|NCT03192176|147297615|SUPERIORITY||LSMean difference|30.2|STANDARD_ERROR_OF_MEAN|7.03|<|0.0001|TWO_SIDED|95.0|16.39|44.06||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||44.06|16.39|<0.0001
74011837|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.36|||||TWO_SIDED|95.0|-0.9|0.18|||Mixed Models Analysis|Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis||0.18|-0.9|
74093941|NCT00655876|147738859|SUPERIORITY|||||||0.77|||||||Chi-squared|Two-sided significance level = 0.05||1 year||||0.77
74093942|NCT00655876|147738859|SUPERIORITY|||||||0.17|||||||Chi-squared|Two-sided significance level = 0.05||2 years||||0.17
74042154|NCT03404219|147636035|OTHER|Single group pre-post, follow-up|Mean Difference (Final Values)|2.56||||0.09|TWO_SIDED||||||General Linear Model (repeated measures)|||Single arm||||0.09
74042155|NCT02038790|147636038|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||>0.5000
74042156|NCT02038790|147636039|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.0196
74042157|NCT02038790|147636040|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.0006
74042158|NCT02038790|147636041|SUPERIORITY_OR_OTHER|||||||0.4422|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.4422
74042159|NCT02038790|147636042|SUPERIORITY_OR_OTHER|||||||0.2377|TWO_SIDED||||||Chi-squared|||||||0.2377
74042160|NCT02038790|147636043|SUPERIORITY_OR_OTHER|||||||0.0603|TWO_SIDED||||||Chi-squared|||||||0.0603
74042161|NCT02038790|147636044|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.0010
74042162|NCT00438464|147636080|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74042163|NCT00438464|147636081|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
74042164|NCT00438464|147636082|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74042165|NCT00438464|147636083|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.805
74042166|NCT00438464|147636084|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.254
74093943|NCT01831765|147738861|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.23|-0.07||||||Change from baseline in HbA1c analysed using a mixed effect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||-0.07|-0.23|
74042167|NCT00438464|147636085|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within GG3||||0.70
74042168|NCT00438464|147636085|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG3||||0.38
74042169|NCT00438464|147636085|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG3||||0.41
74042170|NCT00438464|147636085|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG3||||0.75
74042171|NCT00438464|147636085|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG3||||0.57
74042172|NCT00438464|147636085|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ubiquitin-conjugating enzyme E2C (UBE2C), Within GG3||||0.12
74042173|NCT00438464|147636085|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Cleaved Caspase 3 (Caspase), Within GG3||||0.03
74042174|NCT00438464|147636086|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Vascular Epithelial Growth Factor (VEGF3), Within GG4||||0.45
74042175|NCT00438464|147636086|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG4||||0.83
74042176|NCT00438464|147636086|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG4||||0.04
74042177|NCT00438464|147636086|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG4||||0.80
74042178|NCT00438464|147636086|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG4||||0.61
74042179|NCT00438464|147636086|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within GG4||||0.86
74042180|NCT00438464|147636086|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within GG4||||0.02
74042181|NCT00438464|147636091|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Finasteride Arm||||0.84
74042182|NCT00438464|147636091|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Finasteride Arm||||0.36
74042183|NCT00438464|147636091|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||AR, Within Finasteride||||0.09
74042184|NCT00438464|147636091|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Finasteride Arm||||0.46
74042185|NCT00438464|147636091|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Finasteride Arm||||0.88
74042186|NCT00438464|147636091|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Finasteride Arm||||0.18
74042187|NCT00438464|147636091|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Finasteride Arm||||<0.001
74042188|NCT00438464|147636092|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Placebo Arm||||0.32
74042189|NCT00438464|147636092|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Placebo Arm||||0.83
74042190|NCT00438464|147636092|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||AR, Within Placebo Arm||||0.77
74042191|NCT00438464|147636092|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Placebo Arm||||0.87
74042192|NCT00438464|147636092|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Placebo Arm||||0.91
74042193|NCT00438464|147636092|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Placebo Arm||||0.90
74042194|NCT00438464|147636092|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Placebo Arm||||<0.001
74042195|NCT03943446|147636097|SUPERIORITY||Estimated Difference in ER Rate|-0.1|||=|0.59|TWO_SIDED|95.0|-0.44|0.23|||Fisher Exact|||||0.23|-0.44|=0.590
74042196|NCT03943446|147636097|SUPERIORITY||Estimated difference in ERR|-0.01|||=|1|TWO_SIDED|95.0|-0.34|0.31|||Fisher Exact|||||0.31|-0.34|=1.000
74042197|NCT00270998|147636138|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||<0.0492
74042198|NCT00270998|147636138|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.02||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||0.02
74042199|NCT00270998|147636138|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.49||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||0.49
74042200|NCT00270998|147636139|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.006|||||||Regression, Logistic|||||||0.006
74042201|NCT00270998|147636139|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.048|||||||Regression, Logistic|||||||0.048
74042202|NCT00270998|147636139|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.42|||||||Regression, Logistic|||||||0.42
74042203|NCT00270998|147636140|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042204|NCT00270998|147636140|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74093944|NCT01831765|147738861|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.04|0.12||||||Change from baseline in HbA1c analysed using a mixedeffect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.12|-0.04|
74042205|NCT00270998|147636140|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042206|NCT00270998|147636141|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042207|NCT00270998|147636141|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042208|NCT00270998|147636141|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74011838|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.37|||||TWO_SIDED|95.0|-0.88|0.15|||Mixed Models Analysis|Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis||0.15|-0.88|
74011839|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||||TWO_SIDED|95.0|-1.27|-0.24|||Mixed Models Analysis|Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis||-0.24|-1.27|
74011840|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.45|||||TWO_SIDED|95.0|-0.9|0.0|||Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis||0|-0.9|
74011841|NCT00552175|147574486|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.52|||||TWO_SIDED|95.0|-0.97|-0.07|||Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis||-0.07|-0.97|
74011842|NCT00552175|147574487|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11||||0.8517|TWO_SIDED|95.0|-1.22|1.01|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||1.01|-1.22|0.8517
74011843|NCT00552175|147574488|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34|||||TWO_SIDED|95.0|-1.03|1.71|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||1.71|-1.03|
74011844|NCT00552175|147574488|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|||||TWO_SIDED|95.0|-1.92|0.81|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.81|-1.92|
74011845|NCT00804570|147574503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3||||0.12|TWO_SIDED|95.0|-9.72|1.13|||Mixed Models Analysis|||||1.13|-9.72|0.120
74011846|NCT00804570|147574504|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.013|TWO_SIDED|95.0|-1.27|-0.15|||Mixed Models Analysis|||||-0.15|-1.27|0.013
74011847|NCT00804570|147574505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.37||||0.051|TWO_SIDED|95.0|-0.02|10.77|||Mixed Models Analysis|||||10.77|-0.02|0.051
74042209|NCT00270998|147636142|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042210|NCT00270998|147636142|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042211|NCT00270998|147636142|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74011848|NCT00804570|147574506|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.249|TWO_SIDED|95.0|-1.07|0.28|||Mixed Models Analysis|||||0.28|-1.07|0.249
74011849|NCT00804570|147574507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.199|TWO_SIDED|95.0|-1.12|0.23|||Mixed Models Analysis|||||0.23|-1.12|0.199
74011850|NCT00804570|147574508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68||||0.318|TWO_SIDED|95.0|-2.03|0.66|||Mixed Models Analysis|||||0.66|-2.03|0.318
74011851|NCT00804570|147574509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01||||0.034|TWO_SIDED|95.0|-5.8|-0.22|||Mixed Models Analysis|||||-0.22|-5.80|0.034
74011852|NCT00804570|147574510|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.9||||0.001|TWO_SIDED|95.0|0.85|0.96|||Mixed Models Analysis|||||0.96|0.85|0.001
74011853|NCT00804570|147574511|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.96||||0.103|TWO_SIDED|95.0|0.91|1.01|||Mixed Models Analysis|||||1.01|0.91|0.103
74011854|NCT00804570|147574512|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.94||||0.012|TWO_SIDED|95.0|0.89|0.99|||Mixed Models Analysis|||||0.99|0.89|0.012
74011855|NCT00804570|147574513|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32||||0.392|TWO_SIDED|95.0|-1.05|0.41|||Mixed Models Analysis|||||0.41|-1.05|0.392
74011856|NCT00804570|147574514|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.185|TWO_SIDED|95.0|-1.1|0.21|||Mixed Models Analysis|||||0.21|-1.10|0.185
74011857|NCT00804570|147574515|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.25||||0.142|TWO_SIDED|95.0|-0.42|2.92|||ANCOVA|||||2.92|-0.42|0.142
74011858|NCT00804570|147574516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.69|TWO_SIDED|95.0|-1.01|0.04||P-value is for desire to stop drinking at this time.|ANCOVA|||||0.04|-1.01|0.69
74011859|NCT00804570|147574516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.545|TWO_SIDED|95.0|-0.85|0.45||P-value is for expectation of success in quitting alcohol.|ANCOVA|||||0.45|-0.85|0.545
74011860|NCT00804570|147574516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.19|TWO_SIDED|95.0|-1.2|0.24||P-value is for difficulty to quit and remain abstinent.|ANCOVA|||||0.24|-1.20|0.190
74011861|NCT00804570|147574516|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04||||0.856|TWO_SIDED|95.0|-0.49|0.4||P-value is for goal related to alcohol use.|ANCOVA|||||0.40|-0.49|0.856
74011862|NCT00804570|147574517|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.297|TWO_SIDED|95.0|-0.68|2.22|||Mixed Models Analysis|||||2.22|-0.68|0.297
74011863|NCT00804570|147574518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46||||0.633|TWO_SIDED|95.0|-1.44|2.36|||Mixed Models Analysis|||||2.36|-1.44|0.633
74011864|NCT00804570|147574521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.409|TWO_SIDED|95.0|-2.62|1.07||P-value is for supine systolic blood pressure.|Mixed Models Analysis|||||1.07|-2.62|0.409
74042212|NCT00270998|147636143|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042213|NCT00270998|147636143|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042214|NCT00270998|147636143|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042215|NCT00270998|147636144|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.03|||||||Regression, Logistic|||||||0.03
74042216|NCT00270998|147636144|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.048|||||||Regression, Logistic|||||||0.048
74042217|NCT00270998|147636144|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042218|NCT00270998|147636145|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042219|NCT00270998|147636145|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042220|NCT00270998|147636145|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
74042221|NCT03258632|147636146|SUPERIORITY||Odds Ratio (OR)|1.17|||<|0.05|TWO_SIDED|95.0|0.73|1.9|||Mixed Models Analysis|||||1.90|0.73|<.05
74042222|NCT00788697|147636155|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|11.3||||0.0754|TWO_SIDED|95.0|-1.0|23.6|||McNemar|||||23.6|-1.0|0.0754
74042223|NCT00788697|147636155|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|19.4||||0.0011|TWO_SIDED|95.0|8.3|30.5|||McNemar|||||30.5|8.3|0.0011
74042224|NCT00788697|147636155|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|-19.4||||0.0016|TWO_SIDED|95.0|-30.9|-7.8|||McNemar|||||-7.8|-30.9|0.0016
74042225|NCT00788697|147636156|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|47.4|||<|0.0001|TWO_SIDED|95.0|37.4|57.4|||McNemar|||||57.4|37.4|<.0001
74042226|NCT00788697|147636156|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|60.3|||<|0.0001|TWO_SIDED|95.0|50.5|70.2|||McNemar|||||70.2|50.5|<.0001
74042227|NCT00788697|147636156|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|29.3|||<|0.0001|TWO_SIDED|95.0|19.7|38.9|||McNemar|||||38.9|19.7|<.0001
74093945|NCT02731326|147738914|EQUIVALENCE|The study was designed to have 80% power to detect a hazard ratio of 2 for recurrence detection (α = .05).|Hazard Ratio (HR)|1.56||||0.05|TWO_SIDED|95.0|1.06|2.3|||Regression, Cox||Treatment arm equals numerator. Control arm=denominator.|The study was designed to have 80% power to detect a hazard ratio of 2 for recurrence detection (α = .05). Kaplan-Meier curves were created for recurrence detection in the intervention and control groups over the 6-month follow-up period. Differences in time to recurrence between groups were assessed using a Cox proportional hazards model. Baseline variables that differed significantly between groups were included as covariates and adjusted Kaplan-Meier curves were constructed.||2.30|1.06|0.05
74093946|NCT02731326|147738915|EQUIVALENCE|The study was designed to have 80% power to detect a hazard ratio of 2 (α = .05).|Hazard Ratio (HR)|0.33||||0.05|TWO_SIDED|95.0|0.09|0.58|||Regression, Cox||Treatment arm equals numerator. Control arm=denominator.|Kaplan-Meier curves were created for assessing time to treatment for intervention and control groups. Time to treatment was defined as the time interval from detection of a recurrent arrhythmia to treatment for that arrhythmia.||0.58|0.09|0.05
74042228|NCT00788697|147636157|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|28.8|||<|0.0001|TWO_SIDED|95.0|20.5|37.0|||McNemar|||||37.0|20.5|<.0001
74042229|NCT00788697|147636157|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|39.2|||<|0.0001|TWO_SIDED|95.0|31.3|47.1|||McNemar|||||47.1|31.3|<.0001
74011865|NCT00804570|147574521|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45||||0.452|TWO_SIDED|95.0|-1.63|0.73||P-value is for supine diastolic blood pressure.|Mixed Models Analysis|||||0.73|-1.63|0.452
74011866|NCT00804570|147574522|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53||||0.456|TWO_SIDED|95.0|-1.93|0.87|||Mixed Models Analysis|||||0.87|-1.93|0.456
74011867|NCT00804570|147574523|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.08||||0.081|TWO_SIDED|95.0|-4.41|0.26|||Mixed Models Analysis|||||0.26|-4.41|0.081
74011868|NCT00804570|147574524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0|||||Fisher Exact|||||||0.122
74011869|NCT00804570|147574525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Fisher Exact|||||||0.002
74011870|NCT00804570|147574526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69||||0.235|TWO_SIDED|95.0|-1.82|0.45||P-value is for orthostatic systolic blood pressure.|Mixed Models Analysis|||||0.45|-1.82|0.235
74011871|NCT00804570|147574526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.4|TWO_SIDED|95.0|-1.05|0.42||P-value is for orthostatic diastolic blood pressure.|Mixed Models Analysis|||||0.42|-1.05|0.400
74011872|NCT00804570|147574527|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74||||0.077|TWO_SIDED|95.0|-0.08|1.57|||Mixed Models Analysis|||||1.57|-0.08|0.077
74011873|NCT00804570|147574529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|||<|0.001|TWO_SIDED|95.0|0.24|0.9|||Mixed Models Analysis|||||0.90|0.24|<0.001
74011874|NCT00290342|147574530|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to diphtheria, standardized asymptotic 95% CI for the groups'difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to diphteria||1.79|-1.85|
74042230|NCT00788697|147636157|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|4.2||||0.3173|TWO_SIDED|95.0|-4.0|12.3|||McNemar|||||12.3|-4.0|0.3173
74042231|NCT00788697|147636158|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
74042232|NCT00788697|147636158|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
74042233|NCT00788697|147636158|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wald Test|||||||0.0004
74042234|NCT00788697|147636159|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
74042235|NCT00788697|147636159|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
74042236|NCT00788697|147636159|SUPERIORITY_OR_OTHER|||||||0.761|||||||Wald Test|||||||0.7610
74042237|NCT01998880|147636163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.36|0.59||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.59|0.36|<0.0001
74042238|NCT01998880|147636165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.31|0.5|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.50|0.31|<0.0001
74042239|NCT01998880|147636166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2841|TWO_SIDED|95.0|0.61|1.16|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||1.16|0.61|0.2841
74042240|NCT01998880|147636167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.31|||<|0.0001|TWO_SIDED|95.0|23.5|45.1|||Chi-squared|||||45.1|23.5|<0.0001
74042241|NCT01998880|147636169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.35|0.61|||Log-ranked, Stratified||Stratified by Binet stage at Baseline.|||0.61|0.35|<0.0001
74042242|NCT01998880|147636173|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.4|||<|0.0001|TWO_SIDED|95.0|0.3|0.53|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.53|0.30|<0.0001
74042243|NCT01998880|147636174|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.45|||<|0.0001|TWO_SIDED|95.0|0.31|0.65|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.65|0.31|<0.0001
74042244|NCT01998880|147636175|SUPERIORITY||Difference in Response Rates|33.04|||<|0.0001|TWO_SIDED|95.0|22.1|43.9|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.||43.9|22.1|< 0.0001
74042245|NCT01412060|147636182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.001|TWO_SIDED|95.0|0.28|0.73|||Log Rank||Hazard ratio (cariprazine 3-9 mg vs placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||0.73|0.28|0.0010
74042246|NCT00004732|147636188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.81|1.51|||||HR (95% CI) adjusted for age, sex and symptomatic status|||1.51|0.81|
74042247|NCT00004732|147636189|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.82|2.23|||||HR (95% CI) for WOMEN CAS vs CEA (adjusted for age and symptomatic status)|||2.23|0.82|
74042248|NCT01183312|147636190|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||wilcoxon signed rank (paired)|||||||0.77
74042249|NCT01183312|147636191|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.51
74042250|NCT01183312|147636192|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.32
74093947|NCT02731326|147738916|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.19|0.58|||Regression, Cox|||||0.58|0.19|<.0001
74093948|NCT02731326|147738917|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
74011875|NCT00290342|147574530|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to tetanus, standardized asymptotic 95% CI for the groups'difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to tetanus||1.79|-1.85|
74042251|NCT01183312|147636193|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.56
74042252|NCT01183312|147636194|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.14
74042253|NCT01183312|147636195|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.89
74042254|NCT01183312|147636196|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.13
74042255|NCT00605072|147636243|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||p-value for between group comparison (group\*visit)|Mixed Models Analysis|Adjusted for baseline AGE and Mini-Mental-State-Examination||||||0.008
74042256|NCT00605072|147636244|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Mixed Models Analysis|adjusted for age||||||0.74
74042257|NCT00605072|147636245|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Mixed Models Analysis|Adjusted for age at baseline||||||0.81
74042258|NCT00605072|147636246|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Mixed Models Analysis|||||||0.87
74042259|NCT00605072|147636247|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Mixed Models Analysis|||||||0.79
74042260|NCT00141037|147636253|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon Nonparametric Test|||The endpoint is assessed using a Wilcoxon nonparametric test and missing values are imputed using the last observation carried forward.||||0.79
74042261|NCT00141037|147636254|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||The difference was analyzed using a Fisher's exact test.||||0.85
74093949|NCT02731326|147738918|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
74093950|NCT04647721|147738939|NON_INFERIORITY|Non-inferiority margin of 0.5. The two-sided 95% confidence interval (CI) for the treatment difference was constructed using the repeated-measures analysis of covariance (ANCOVA).|Difference in Least Squares Means|0.03|||||TWO_SIDED|95.0|-0.07|0.12||||||||0.12|-0.07|
74093951|NCT04647721|147738940|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.35|6.35||||||||6.35|-6.35|
74093952|NCT04647721|147738941|OTHER||Risk Difference (RD)|1.75|||||TWO_SIDED|95.0|-3.08|6.74||||||||6.74|-3.08|
74011876|NCT00290342|147574531|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 1, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.82||||||Immune response non-inferiority - Anti-Polio 1||1.82|-1.85|
74011877|NCT00290342|147574531|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 2, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.49|||||TWO_SIDED|95.0|-1.36|2.71||||||Immune response non-inferiority - Anti-Polio 2||2.71|-1.36|
74011878|NCT00290342|147574531|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 3, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|-0.01|||||TWO_SIDED|95.0|-2.28|2.24||||||Immune response non-inferiority - Anti-Polio 3||2.24|-2.28|
74042262|NCT01938001|147636259|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.34|0.62|||Log Rank|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).|Hazard ratio and its confidence interval (CI) were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.|||0.62|0.34|< 0.0001
74042263|NCT01938001|147636260|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||0.0006
74042264|NCT01938001|147636261|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.37|0.95||||||Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||0.95|0.37|
74042265|NCT01938001|147636262|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||< 0.0001
74042266|NCT01938001|147636263|SUPERIORITY||||||=|0.001|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||= 0.0010
74042267|NCT01938001|147636264|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0015|TWO_SIDED|95.0|0.36|0.79|||Log Rank|||||0.79|0.36|0.0015
74042268|NCT01938001|147636265|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.2993|TWO_SIDED|95.0|0.32|1.43|||Log Rank|||||1.43|0.32|0.2993
74042269|NCT01938001|147636266|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Stratified Log-Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).|Hazard ratio and its CI were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.|||0.67|0.38|< 0.0001
74042270|NCT01938001|147636267|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.39|0.71|||Stratified Log Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||0.71|0.39|<0.0001
74042271|NCT01569087|147636279|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
74042272|NCT00892957|147636299|SUPERIORITY_OR_OTHER||||||<|0.0001|ONE_SIDED|95.0|||||Likelihood ratio chi-square test|||||||<0.0001
74042273|NCT00892957|147636300|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.001
74093953|NCT05070546|147738948|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 1\[Group1\] and 2 \[Group 3\])|Geometric Mean Ratio|1.41|||||TWO_SIDED|95.0|1.25|1.6|||Geometric Mean Ratio|||||1.60|1.25|
74042274|NCT00892957|147636301|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.012
74042275|NCT00892957|147636302|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.158
74042276|NCT00892957|147636304|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.380
74042277|NCT00892957|147636305|SUPERIORITY_OR_OTHER|||||||0.545|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.545
74042278|NCT01379924|147636363|SUPERIORITY||Odds Ratio (OR)|0.25||||0.037|TWO_SIDED|95.0|0.07|0.92|||Regression, Logistic|Adjusted for group differences at baseline and variables associated with differential study retention.|Usual care arm is reference group|Multiple logistic regression modeling used to compute adjusted odds ratios for 12-month follow-up data.||.92|.07|.037
74042279|NCT01379924|147636364|SUPERIORITY||Odds Ratio (OR)|0.24||||0.029|TWO_SIDED|95.0|0.07|0.86|||Regression, Logistic|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.|Usual care arm is reference group.|||.86|.07|.029
74042280|NCT01379924|147636365|SUPERIORITY||Odds Ratio (OR)|0.2||||0.017|TWO_SIDED|95.0|0.06|0.75|||Regression, Logistic|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.|Usual care arm is the reference group|||.75|.06|.017
74042281|NCT01379924|147636366|SUPERIORITY||Group by time interaction term coefficie|4.75|STANDARD_ERROR_OF_MEAN|3.84||0.217|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.217
74093954|NCT05070546|147738948|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohort 2 (Group 3 in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 2 \[Group 3\])|Geometric mean ratio|1.54|||||TWO_SIDED|95.0|1.34|1.78|||Geometric Mean Ratio|||||1.78|1.34|
74042282|NCT01379924|147636367|SUPERIORITY||Group by time interaction term coefficie|2.89|STANDARD_ERROR_OF_MEAN|3.77||0.444|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.444
74011879|NCT00290342|147574532|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertussis toxoid, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|1.44|||||TWO_SIDED|95.0|-0.46|4.13||||||Immune response non-inferiority - Anti-PT||4.13|-0.46|
74011880|NCT00290342|147574532|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to filamentous haemagglutinin, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.45|||||TWO_SIDED|95.0|-1.88|2.95||||||Immune response non-inferiority - Anti-FHA||2.95|-1.88|
74011881|NCT00290342|147574532|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertactin, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.47|||||TWO_SIDED|95.0|-1.4|2.64||||||Immune response non-inferiority - Anti-PRN||2.64|-1.4|
74011882|NCT01056510|147574543|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||The first-line subpopulation became the focus of the primary statistical analysis following the protocol amendment dated 21-May-2012.||||0.002
74011883|NCT01056510|147574544|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||||||< 0.001
74011884|NCT01056510|147574545|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||||||0.009
74011885|NCT01056510|147574546|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 3 cycles||||0.900
74011886|NCT01056510|147574546|SUPERIORITY_OR_OTHER|||||||0.563|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 6 cycles||||0.563
74011887|NCT01056510|147574546|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||At the EOT visit||||0.304
74011888|NCT01056510|147574549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.525||||0.003|TWO_SIDED|95.0|0.341|0.809|||Log Rank|||Unstratified analysis||0.809|0.341|0.003
74011889|NCT01056510|147574549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.523||||0.003|TWO_SIDED|95.0|0.339|0.806|||Log Rank|||Stratified analysis: by baseline Binet stage||0.806|0.339|0.003
74042283|NCT01379924|147636368|SUPERIORITY||Group by time interaction term coefficie|9.76|STANDARD_ERROR_OF_MEAN|3.82||0.011|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.011
74011890|NCT01056510|147574551|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Log Rank|||||||0.029
74011891|NCT01056510|147574553|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Log Rank|||||||0.006
74011892|NCT01056510|147574555|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Log Rank|||||||0.037
74011893|NCT01056510|147574557|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Log Rank|||||||0.007
74011894|NCT01056510|147574559|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.994||||0.986|TWO_SIDED|95.0|0.517|1.911||Unstratified analysis|Log Rank|||||1.911|0.517|0.986
74011895|NCT01056510|147574559|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.939|TWO_SIDED|95.0|0.505|1.88|||Log Rank|||Stratified analysis: by baseline Binet stage||1.880|0.505|0.939
74011896|NCT01056510|147574560|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||||||< 0.001
74011897|NCT00243386|147574563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6016||95.0|||||t-test, 2 sided|||A t-test was used to compare the means of the transformed data. The null-hypothesis tested was H0: X'A(PK-driven prophylaxis) - X'B (standard prophylaxis) = 0 (i.e., no difference for treatment under the 2 prophylactic regimens. X' = (ABR+0.5)\^(1/2)||||0.6016
74011898|NCT00243386|147574564|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-Test|||||||<0.0001
74011899|NCT00243386|147574565|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test|||||||<0.0001
74011900|NCT00243386|147574566|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test|||||||<0.0001
74011901|NCT00243386|147574567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4924||95.0|||||Wilcoxon-Rank Sum (Mann-Whitney)|||||||0.4924
74011902|NCT00243386|147574588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1467||95.0|||||Wilcoxon-Rank Sum (Mann-Whitney)|||||||0.1467
74011903|NCT00243386|147574589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0||||Due to multiple hypotheses testing results, adjusted alpha values are set to α\*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values \< α\*|Wilcoxon signed-rank test|||||||0.0007
74011904|NCT00243386|147574590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||Due to multiple hypotheses testing results, adjusted alpha values are set to α\*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values \< α\*|Wilcoxon signed-rank test|||||||0.0002
74011905|NCT00243386|147574591|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon Signed-Rank Test|||||||<0.0001
74042284|NCT01379924|147636370|SUPERIORITY||Group by time interaction term coefficie|0.64|STANDARD_ERROR_OF_MEAN|0.59||0.758|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.758
74042285|NCT01379924|147636371|SUPERIORITY||Group by time interaction term coefficie|1.36|STANDARD_ERROR_OF_MEAN|0.6||0.024|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.024
74011906|NCT02285998|147574592|NON_INFERIORITY_OR_EQUIVALENCE|The sample size required to achieve 80% power was calculated based on a one-sided alpha level of 0.025 and an attack rate of 2% in the IIV4 and 1.53% for the Flublok groups respectively.|Relative Vaccine Efficacy (rVE)|30.0|||||TWO_SIDED|95.0|10.0|47.0||||||The primary efficacy analysis was based on the numbers of protocol-defined influenza-like illnesses with rtPCR-positive nasopharyngeal swabs detecting influenza virus of any strain. The Relative Vaccine Efficacy was 30% (10, 47). Non-inferiority would be concluded if the lower bound of the 95% CI for rVE was \> -20%. Superiority of RIV4 in a pre-specified exploratory analysis required that the lower bound of the two-sided 95% CI of rVE be \> +9%.||47|10|
74042286|NCT01379924|147636372|SUPERIORITY||Group by time interaction term coefficie|2.67|STANDARD_ERROR_OF_MEAN|2.88||0.354|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up||||||.354
74042287|NCT01379924|147636373|SUPERIORITY||Group by time interaction term coefficie|4.43|STANDARD_ERROR_OF_MEAN|2.85||0.121|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.121
74011907|NCT03002155|147574607|SUPERIORITY|||||||0.26||||||Not adjusted for multiple comparisons due to the pilot nature of the study, alpha level was 0.10.|ANOVA|||||||.26
74011908|NCT03002155|147574608|SUPERIORITY|||||||0.38|||||||ANOVA|||||||0.38
74011909|NCT03002155|147574609|SUPERIORITY|||||||0.24|||||||ANOVA|||For PROMIS Global Physical||||0.24
74011910|NCT03002155|147574609|SUPERIORITY|||||||0.8||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||For PROMIS Global Mental||||0.80
74011911|NCT03002155|147574610|SUPERIORITY|||||||0.81||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||||||0.81
74011912|NCT03002155|147574611|SUPERIORITY|||||||0.03||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||||||0.03
74042288|NCT01379924|147636374|SUPERIORITY||Group by time interaction term coefficie|3.67|STANDARD_ERROR_OF_MEAN|2.89||0.205|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.205
74042289|NCT01379924|147636375|SUPERIORITY||Group by time interaction term coefficie|0.65|STANDARD_ERROR_OF_MEAN|2.6||0.803|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.803
74042290|NCT01379924|147636376|SUPERIORITY||Group by time interaction term coefficie|2.41|STANDARD_ERROR_OF_MEAN|2.56||0.347|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.347
74011913|NCT00978029|147574619|SUPERIORITY_OR_OTHER||Percent Difference|6.9||||0.486|TWO_SIDED|95.0|-10.17|23.97|||Fisher Exact|||||23.97|-10.17|0.486
74042291|NCT01379924|147636377|SUPERIORITY||Group by time interaction term coefficie|-1.39|STANDARD_ERROR_OF_MEAN|2.59||0.591|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.591
74011914|NCT00978029|147574619|SUPERIORITY_OR_OTHER||Percent Difference|16.9||||0.078|TWO_SIDED|95.0|0.01|33.83|||Fisher Exact|||||33.83|0.01|0.078
74011915|NCT03418129|147574662|SUPERIORITY||Slope|0.2331|STANDARD_ERROR_OF_MEAN|0.2176||0.2852|TWO_SIDED||||||ANCOVA||Multilevel modeling was used to model outcome at baseline and 3-month follow-up. Resulting slopes capture change in outcome from baseline to follow-up, with relaxation set as the comparison.|||||0.2852
74011916|NCT03418129|147574662|SUPERIORITY||Slope|0.03057|STANDARD_ERROR_OF_MEAN|0.2132||0.8861|TWO_SIDED||||||ANCOVA||Multilevel modeling was used to model outcome at baseline and 3-month follow-up. Resulting slopes capture change in outcome from baseline to follow-up, with relaxation set as the comparison.|||||0.8861
74011917|NCT03418129|147574663|SUPERIORITY||Slope|-0.03844|STANDARD_ERROR_OF_MEAN|0.09424||0.6842|TWO_SIDED||||||ANOVA||Multilevel modeling was used to model outcomes at two time points (3-month follow-up and baseline) and across three treatment groups (Mindfulness, Neurofeedback, and Relaxation).|||||0.6842
74011918|NCT03418129|147574663|SUPERIORITY||Slope|-0.1432|STANDARD_ERROR_OF_MEAN|0.09427||0.132|TWO_SIDED||||||ANOVA||Multilevel modeling was used to model outcomes at two time points (3-month follow-up and baseline) and across three treatment groups (Mindfulness, Neurofeedback, and Relaxation).|||||0.132
74011919|NCT03418129|147574664|SUPERIORITY||Slope|0.1911|STANDARD_ERROR_OF_MEAN|0.2551||0.4542|TWO_SIDED||||||ANCOVA|||||||0.4542
74011920|NCT03418129|147574664|SUPERIORITY||Slope|-0.3761|STANDARD_ERROR_OF_MEAN|0.2454||0.1261|TWO_SIDED||||||ANCOVA|||||||0.1261
74011921|NCT01553188|147574668|SUPERIORITY|||||||0.44|||||||Log rank two-tailed p-value|||||||0.44
74011922|NCT01553188|147574670|SUPERIORITY|||||||0.26|||||||Log rank two-tailed p-value|||||||0.26
74011923|NCT04744207|147574685|SUPERIORITY||Least squares mean estimate|0.81|||<|0.05|TWO_SIDED|95.0|-2.48|4.1|||ANCOVA|||||4.10|-2.48|<0.05
74011924|NCT05376215|147574699|NON_INFERIORITY|The non-inferiority margin of -12.5 was used per the findings from Chisolm, et al (2005), see attached article. In that study, the smallest critical difference for the short term retest difference was 12.5 for the APHAB global score at the 90th percentile. For this study, non-inferiority is confirmed if Fitting Method B is no more than 12.5 percentage points below the mean global benefit score of Fitting Method A.||||||0.806|||||||Mixed Models Analysis|||||||0.806
74011925|NCT05376215|147574700|NON_INFERIORITY|The non-inferiority margin is -1.8 dB. This is based off of work by Killion (2004) in which the critical difference for 4 lists is 1.9 dB at the 95% confidence interval. Killion also found that if all 12 lists are presented, the mean SNR scores will differ by 1.8 dB 5% of the time.||||||0.889|||||||Mixed Models Analysis|||||||0.889
74011926|NCT01947816|147574703|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24||||< 0.0001
74011927|NCT01947816|147574703|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52||||< 0.0001
74011928|NCT01947816|147574703|SUPERIORITY|||||||0.5512|||||||paired t-test|||Change from Baseline When Discontinued||||0.5512
74011929|NCT01947816|147574703|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment||||< 0.0001
74011930|NCT01947816|147574705|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 4||||< 0.0001
74011931|NCT01947816|147574705|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 8||||< 0.0001
74011932|NCT01947816|147574705|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 16||||< 0.0001
74011933|NCT01947816|147574705|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24||||< 0.0001
74011934|NCT01947816|147574705|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52||||< 0.0001
74011935|NCT01947816|147574705|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline when discontinued||||< 0.0001
74042292|NCT04532918|147636400|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|255.3|||||TWO_SIDED|90.0|208.7|312.3|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax||312.3|208.7|
74011936|NCT01947816|147574705|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment||||< 0.0001
74011937|NCT00078325|147574721|SUPERIORITY_OR_OTHER|||||||0.0001|||||||ANOVA|Treatment and country as factors.||||||0.0001
74011938|NCT00078325|147574721|SUPERIORITY_OR_OTHER|||||||0.0008|||||||ANOVA|Treatment and country as factors.||||||0.0008
74011939|NCT00078325|147574722|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.||||||<0.0001
74011940|NCT00078325|147574722|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.||||||<0.0001
74011941|NCT03710486|147574729|SUPERIORITY||Odds Ratio (OR)|0.61|||=|0.13202|TWO_SIDED|95.0|0.32|1.16|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by propensity scores inverse probability treatment weighting (PS-IPTW).|Estimated with a logistic regression adjusted by PS-IPTW.|||1.16|0.32|=0.13202
74011942|NCT03710486|147574730|SUPERIORITY||Odds Ratio (OR)|1.18|||=|0.5861|TWO_SIDED|95.0|0.65|2.13|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.13|0.65|=0.5861
74011943|NCT03710486|147574733|SUPERIORITY||Odds Ratio (OR)|0.65|||=|0.1648|TWO_SIDED|95.0|0.35|1.19|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.19|0.35|=0.1648
74011944|NCT03710486|147574734|SUPERIORITY||Odds Ratio (OR)|0.66|||=|0.1732|TWO_SIDED|95.0|0.36|1.2|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.20|0.36|=0.1732
74011945|NCT03710486|147574737|SUPERIORITY||||||=|0.2011|||||||Log Rank Test Adjusted by PS-IPTW|p-value was estimated with Log Rank test adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.||CD: Vedolizumab Versus Other Biological||||=0.2011
74011946|NCT03710486|147574738|SUPERIORITY||||||=|0.6939|||||||Log Rank Test Adjusted by PS-IPTW|p-value was estimated with Log Rank test adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.||||||=0.6939
74011947|NCT03710486|147574739|SUPERIORITY||Odds Ratio (OR)|0.29|||=|0.0071|TWO_SIDED|95.0|0.12|0.71|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.71|0.12|=0.0071
74011948|NCT03710486|147574740|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.4809|TWO_SIDED|95.0|0.64|2.55|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.55|0.64|=0.4809
74011949|NCT03710486|147574741|SUPERIORITY||Odds Ratio (OR)|1.05|||=|0.915|TWO_SIDED|95.0|0.46|2.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.36|0.46|=0.9150
74011950|NCT03710486|147574742|SUPERIORITY||Odds Ratio (OR)|1.13|||=|0.7254|TWO_SIDED|95.0|0.56|2.28|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.28|0.56|=0.7254
74011951|NCT03710486|147574743|SUPERIORITY||Odds Ratio (OR)|0.34|||=|0.0051|TWO_SIDED|95.0|0.16|0.72|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.72|0.16|=0.0051
74011952|NCT03710486|147574744|SUPERIORITY||Odds Ratio (OR)|0.53|||=|0.0653|TWO_SIDED|95.0|0.27|1.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.04|0.27|=0.0653
74011953|NCT03710486|147574745|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.7629|TWO_SIDED|95.0|0.47|1.74|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.74|0.47|=0.7629
74011954|NCT03710486|147574746|SUPERIORITY||Odds Ratio (OR)|0.8|||=|0.4895|TWO_SIDED|95.0|0.43|1.5|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.50|0.43|=0.4895
74011955|NCT03710486|147574747|SUPERIORITY||Odds Ratio (OR)|0.76|||=|0.4458|TWO_SIDED|95.0|0.38|1.54|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.54|0.38|=0.4458
74011956|NCT03710486|147574748|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.9471|TWO_SIDED|95.0|0.47|2.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.04|0.47|=0.9471
74011957|NCT03710486|147574749|SUPERIORITY||Odds Ratio (OR)|0.42|||=|0.0104|TWO_SIDED|95.0|0.21|0.81|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.81|0.21|=0.0104
73879670|NCT03192176|147297615|SUPERIORITY||LSMean difference|15.9|STANDARD_ERROR_OF_MEAN|7.02||0.024|TWO_SIDED|95.0|2.11|29.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||29.71|2.11|0.0240
73879671|NCT03192176|147297615|SUPERIORITY||LSMean difference|24.5|STANDARD_ERROR_OF_MEAN|7.05||0.0006|TWO_SIDED|95.0|10.62|38.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||38.37|10.62|0.0006
73879672|NCT03192176|147297615|SUPERIORITY||LSMean differencce|33.7|STANDARD_ERROR_OF_MEAN|7.03|<|0.0001|TWO_SIDED|95.0|19.87|47.52||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||47.52|19.87|<0.0001
74011958|NCT03710486|147574750|SUPERIORITY||Odds Ratio (OR)|0.26|||=|0.0011|TWO_SIDED|95.0|0.12|0.59|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.59|0.12|=0.0011
74011959|NCT03710486|147574751|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.9471|TWO_SIDED|95.0|0.47|2.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|CD Participants||2.04|0.47|=0.9471
74011960|NCT03710486|147574752|SUPERIORITY||Odds Ratio (OR)|0.3|||=|0.0104|TWO_SIDED|95.0|0.12|0.75|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.75|0.12|=0.0104
74011961|NCT03710486|147574753|SUPERIORITY||Odds Ratio (OR)|0.26|||=|0.0011|TWO_SIDED|95.0|0.12|0.59|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.59|0.12|=0.0011
74011962|NCT03710486|147574754|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.54|TWO_SIDED|95.0|0.59|2.78|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.78|0.59|=0.5400
74093955|NCT05070546|147738949|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 1\[Group1\] and 2 \[Group 3\]).|Difference in Seroresponse rate|5.4|||||TWO_SIDED|95.0|0.3|10.9|||Difference in Seroresponse rate|||||10.9|0.3|
74011963|NCT03710486|147574755|SUPERIORITY||Odds Ratio (OR)|1.21|||=|0.8123|TWO_SIDED|95.0|0.26|5.66|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||5.66|0.26|=0.8123
74042293|NCT04532918|147636400|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|189.5|||||TWO_SIDED|90.0|154.0|233.1|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax||233.1|154.0|
73879673|NCT03192176|147297615|SUPERIORITY||LSMean difference|38.0|STANDARD_ERROR_OF_MEAN|7.15|<|0.0001|TWO_SIDED|95.0|23.93|52.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||52.04|23.93|<0.0001
73879674|NCT03192176|147297615|SUPERIORITY||LSMean difference|14.5|STANDARD_ERROR_OF_MEAN|7.16||0.0441|TWO_SIDED|95.0|0.38|28.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||28.53|0.38|0.0441
73879675|NCT03192176|147297615|SUPERIORITY||LSMean difference|19.4|STANDARD_ERROR_OF_MEAN|7.04||0.0061|TWO_SIDED|95.0|5.58|33.28||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||33.28|5.58|0.0061
74011964|NCT03710486|147574756|SUPERIORITY||Odds Ratio (OR)|0.22|||=|0.0282|TWO_SIDED|95.0|0.06|0.85|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.85|0.06|=0.0282
74011965|NCT03710486|147574757|SUPERIORITY||Odds Ratio (OR)|1.13|||=|0.8584|TWO_SIDED|95.0|0.29|4.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||4.36|0.29|=0.8584
74011966|NCT03710486|147574758|SUPERIORITY||Odds Ratio (OR)|0.95|||=|0.9474|TWO_SIDED|95.0|0.24|3.78|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||3.78|0.24|=0.9474
74011967|NCT03710486|147574759|SUPERIORITY||Odds Ratio (OR)|0.73|||=|0.3103|TWO_SIDED|95.0|0.4|1.34|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.34|0.40|=0.3103
74011968|NCT03710486|147574759|SUPERIORITY||Odds Ratio (OR)|0.41|||=|0.0045|TWO_SIDED|95.0|0.22|0.76|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||0.76|0.22|=0.0045
74011969|NCT03710486|147574759|SUPERIORITY||Odds Ratio (OR)|1.19|||=|0.6287|TWO_SIDED|95.0|0.59|2.42|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||2.42|0.59|=0.6287
74042294|NCT04532918|147636401|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|238.4|||||TWO_SIDED|90.0|207.6|273.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf||273.8|207.6|
74093956|NCT05070546|147738949|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 2 \[Group 3\]).|Difference in Seroresponse rate|4.4|||||TWO_SIDED|95.0|-1.6|10.5|||Difference in Seroresponse rate|||||10.5|-1.6|
74093957|NCT00302081|147738951|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.02||||0.041||95.0|-0.1|1.0||The Hochberg procedure was used to adjust for the multiple comparisons (\[PEG2b 1.0/R(24 weeks)\] - \[PEG2b 1.5/R(24 weeks\]) and (\[PEG2b 1.5/R(16 weeks)\]-\[PEG2b 1.5/R(24 weeks)\]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 1.5-dose group and 0.643 (144/224 subjects) in the 1.0-dose group, for a risk difference of -0.02.||This is an evaluation of the effect of the peginterferon alfa-2b dose (1.0 vs 1.5 micrograms/kg/week) on the primary outcome measure.||1|-0.10|0.041
74093958|NCT00302081|147738951|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.1||||0.495||95.0|-0.17|1.0||The Hochberg procedure was used to adjust for the multiple comparisons (\[PEG2b 1.0/R(24 weeks)\] - \[PEG2b 1.5/R(24 weeks\]) and (\[PEG2b 1.5/R(16 weeks\]-\[PEG2b 1.5/R(24 weeks\]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 24-week group and 0.566 (129/228 subjects) in the 16-week group, for a risk difference of -0.10.||This is an evaluation of the effect of treatment duration (24 weeks vs 16 weeks) on the primary outcome measure.||1|-0.17|0.495
74093959|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.17|1.88|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 1: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.88|1.17|
74093960|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.1|||||TWO_SIDED|95.0|0.91|1.35|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 3: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.35|0.91|
74093961|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.93|3.74|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 4: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||3.74|1.93|
74093962|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.55|2.63|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 5: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.63|1.55|
74093963|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|3.0|||||TWO_SIDED|95.0|2.21|4.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 6B: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||4.13|2.21|
74011970|NCT03710486|147574759|SUPERIORITY||Odds Ratio (OR)|0.65|||=|0.2495|TWO_SIDED|95.0|0.31|1.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||1.36|0.31|=0.2495
74011971|NCT03710486|147574760|SUPERIORITY||Risk Ratio (RR)|0.89|||=|0.4784|TWO_SIDED|95.0|0.66|1.22|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.22|0.66|=0.4784
74011972|NCT03710486|147574760|SUPERIORITY||Risk Ratio (RR)|0.83|||=|0.2616|TWO_SIDED|95.0|0.6|1.15|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.15|0.60|=0.2616
74011973|NCT03710486|147574760|SUPERIORITY||Risk Ratio (RR)|2.01|||=|0.0077|TWO_SIDED|95.0|1.2|3.34|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||3.34|1.20|=0.0077
74011974|NCT03710486|147574760|SUPERIORITY||Risk Ratio (RR)|1.3|||=|0.3046|TWO_SIDED|95.0|0.79|2.14|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||2.14|0.79|=0.3046
74011975|NCT03710486|147574761|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.1681|TWO_SIDED|95.0|0.22|1.3|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||1.30|0.22|=0.1681
74011976|NCT03710486|147574761|SUPERIORITY||Odds Ratio (OR)|0.23|||=|0.0645|TWO_SIDED|95.0|0.05|1.09|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||1.09|0.05|=0.0645
74011977|NCT03710486|147574761|SUPERIORITY||Odds Ratio (OR)|0.38|||=|0.3145|TWO_SIDED|95.0|0.06|2.51|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||2.51|0.06|=0.3145
74011978|NCT03710486|147574761|SUPERIORITY||Odds Ratio (OR)|1.49|||=|0.8197|TWO_SIDED|95.0|0.05|47.11|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||47.11|0.05|=0.8197
74011979|NCT03710486|147574762|SUPERIORITY||Risk Ratio (RR)|0.43|||=|0.0239|TWO_SIDED|95.0|0.2|0.89|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||0.89|0.20|=0.0239
74011980|NCT03710486|147574762|SUPERIORITY||Risk Ratio (RR)|0.21|||=|0.0373|TWO_SIDED|95.0|0.05|0.91|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||0.91|0.05|=0.0373
74011981|NCT03710486|147574762|SUPERIORITY||Risk Ratio (RR)|0.54|||=|0.426|TWO_SIDED|95.0|0.12|2.49|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||2.49|0.12|=0.4260
74011982|NCT03710486|147574762|SUPERIORITY||Risk Ratio (RR)|1.56|||=|0.8012|TWO_SIDED|95.0|0.05|48.44|||Poisson Regression||The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||48.44|0.05|=0.8012
74011983|NCT03710486|147574763|SUPERIORITY||Odds Ratio (OR)|0.17|||=|0.0044|TWO_SIDED|95.0|0.05|0.58|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.58|0.05|=0.0044
74011984|NCT03710486|147574763|SUPERIORITY||Odds Ratio (OR)|0.32|||=|0.0215|TWO_SIDED|95.0|0.12|0.84|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.84|0.12|=0.0215
74011985|NCT03710486|147574764|SUPERIORITY||Risk Ratio (RR)|0.27|||=|0.0152|TWO_SIDED|95.0|0.1|0.78|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.78|0.10|=0.0152
74011986|NCT03710486|147574764|SUPERIORITY||Risk Ratio (RR)|1.56|||=|0.8012|TWO_SIDED|95.0|0.05|48.44|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||48.44|0.05|=0.8012
74011987|NCT01147744|147574789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.056||||0.326|TWO_SIDED|95.0|-0.06|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.17|-0.06|0.326
74011988|NCT01147744|147574789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.104||||0.066|TWO_SIDED|95.0|-0.01|0.22||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.22|-0.01|0.066
74011989|NCT01147744|147574789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069||||0.224|TWO_SIDED|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.18|-0.04|0.224
74011990|NCT01147744|147574789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.062||||0.271|TWO_SIDED|95.0|-0.05|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.17|-0.05|0.271
74011991|NCT01147744|147574789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.189|||<|0.001|TWO_SIDED|95.0|0.08|0.3||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.30|0.08|<0.001
74011992|NCT01147744|147574789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.22|TWO_SIDED|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.18|-0.04|0.220
74011993|NCT01147744|147574790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.385||||0.932|TWO_SIDED|95.0|-9.25|8.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||8.48|-9.25|0.932
74011994|NCT01147744|147574790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.367||||0.762|TWO_SIDED|95.0|-7.5|10.23|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||10.23|-7.50|0.762
74011995|NCT01147744|147574790|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.798||||0.689|TWO_SIDED|95.0|-10.62|7.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||7.03|-10.62|0.689
74011996|NCT01147744|147574790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.321||||0.605|TWO_SIDED|95.0|-6.49|11.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||11.13|-6.49|0.605
74042295|NCT04532918|147636401|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|148.9|||||TWO_SIDED|90.0|129.1|171.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf||171.7|129.1|
74011997|NCT01147744|147574790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.46||||0.584|TWO_SIDED|95.0|-6.36|11.28|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||11.28|-6.36|0.584
74011998|NCT01147744|147574790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.529||||0.907|TWO_SIDED|95.0|-8.4|9.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||9.45|-8.40|0.907
74011999|NCT01147744|147574791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.463||||0.753|TWO_SIDED|95.0|-7.65|10.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||10.58|-7.65|0.753
74012000|NCT01147744|147574791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.75||||0.419|TWO_SIDED|95.0|-5.36|12.87|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||12.87|-5.36|0.419
74012001|NCT01147744|147574791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.046||||0.51|TWO_SIDED|95.0|-12.12|6.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||6.03|-12.12|0.510
74012002|NCT01147744|147574791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.585||||0.32|TWO_SIDED|95.0|-4.47|13.64|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||13.64|-4.47|0.320
74042296|NCT04532918|147636402|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|261.8|||||TWO_SIDED|90.0|229.8|298.1|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast||298.1|229.8|
74012003|NCT01147744|147574791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.484||||0.452|TWO_SIDED|95.0|-5.61|12.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||12.58|-5.61|0.452
74012004|NCT01147744|147574791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.615||||0.229|TWO_SIDED|95.0|-3.55|14.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||14.78|-3.55|0.229
74012005|NCT01147744|147574792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.169||||0.771|TWO_SIDED|95.0|-6.73|9.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||9.07|-6.73|0.771
74012006|NCT01147744|147574792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56||||0.257|TWO_SIDED|95.0|-3.33|12.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.45|-3.33|0.257
74012007|NCT01147744|147574792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.326||||0.741|TWO_SIDED|95.0|-6.54|9.19|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||9.19|-6.54|0.741
74042297|NCT04532918|147636402|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|163.2|||||TWO_SIDED|90.0|142.8|186.6|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast||186.6|142.8|
74042298|NCT04532918|147636403|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|273.4|||||TWO_SIDED|90.0|227.9|328.1|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||328.1|227.9|
74042299|NCT04532918|147636403|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|275.9|||||TWO_SIDED|90.0|228.7|332.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||332.7|228.7|
74042300|NCT04532918|147636403|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|24.65|||||TWO_SIDED|90.0|19.15|31.72|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M8||31.72|19.15|
74042301|NCT04532918|147636403|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|37.82|||||TWO_SIDED|90.0|29.18|49.03|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M8||49.03|29.18|
73887996|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.0289|TWO_SIDED|95.0|0.4|6.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.4|0.4|0.0289
74012008|NCT01147744|147574792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083||||0.983|TWO_SIDED|95.0|-7.76|7.93|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||7.93|-7.76|0.983
74042302|NCT04532918|147636404|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|291.8|||||TWO_SIDED|90.0|260.6|326.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M1||326.8|260.6|
74042303|NCT04532918|147636404|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|215.8|||||TWO_SIDED|90.0|192.0|242.4|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||242.4|192.0|
74042304|NCT04532918|147636404|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|55.31|||||TWO_SIDED|90.0|47.19|64.83|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M8||64.83|47.19|
74042305|NCT04532918|147636404|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|68.28|||||TWO_SIDED|90.0|57.99|80.39|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M8||80.39|57.99|
74012009|NCT01147744|147574792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.204||||0.041|TWO_SIDED|95.0|0.34|16.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||16.07|0.34|0.041
74012010|NCT01147744|147574792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.891||||0.475|TWO_SIDED|95.0|-5.05|10.83|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.83|-5.05|0.475
74012011|NCT01147744|147574793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.837||||0.838|TWO_SIDED|95.0|-7.22|8.89|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||8.89|-7.22|0.838
74012012|NCT01147744|147574793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.715||||0.508|TWO_SIDED|95.0|-5.33|10.76|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.76|-5.33|0.508
74012013|NCT01147744|147574793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.124||||0.603|TWO_SIDED|95.0|-5.9|10.14|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.14|-5.90|0.603
74012014|NCT01147744|147574793|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.781||||0.662|TWO_SIDED|95.0|-9.78|6.22|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||6.22|-9.78|0.662
74012015|NCT01147744|147574793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.949||||0.146|TWO_SIDED|95.0|-2.08|13.98|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||13.98|-2.08|0.146
74012016|NCT01147744|147574793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.394||||0.191|TWO_SIDED|95.0|-2.69|13.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||13.48|-2.69|0.191
74042306|NCT04532918|147636405|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|306.4|||||TWO_SIDED|90.0|273.3|343.6|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M1||343.6|273.3|
74012017|NCT01147744|147574794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.106||||0.164|TWO_SIDED|95.0|-2.5|14.71|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||14.71|-2.50|0.164
74012018|NCT01147744|147574794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.106||||0.349||95.0|-4.49|12.7|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.70|-4.49|0.349
74012019|NCT01147744|147574794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.148||||0.623|TWO_SIDED|95.0|-6.42|10.72|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.72|-6.42|0.623
74042307|NCT04532918|147636405|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|227.4|||||TWO_SIDED|90.0|202.1|255.8|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M1||255.8|202.1|
74042308|NCT04532918|147636405|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|51.03|||||TWO_SIDED|90.0|43.8|59.45|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M8||59.45|43.80|
74042309|NCT04532918|147636405|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|70.45|||||TWO_SIDED|90.0|60.21|82.44|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M8||82.44|60.21|
74042310|NCT04532918|147636406|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|74.84|||||TWO_SIDED|90.0|59.42|94.26|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for allopurinol||94.26|59.42|
74093964|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.07|2.18|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 7F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.18|1.07|
74093965|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.36|2.97|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 9V: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.||2.97|1.36|
74093966|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.73|1.33|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 14: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.33|0.73|
74012020|NCT01147744|147574794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.713||||0.694|TWO_SIDED|95.0|-6.84|10.26|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.26|-6.84|0.694
74012021|NCT01147744|147574794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.592||||0.028|TWO_SIDED|95.0|1.03|18.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||18.15|1.03|0.028
74012022|NCT01147744|147574794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.75||||0.125|TWO_SIDED|95.0|-1.89|15.38|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||15.38|-1.89|0.125
74012023|NCT01147744|147574795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.346||||0.585|TWO_SIDED|95.0|-6.09|10.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.78|-6.09|0.585
74012024|NCT01147744|147574795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.431||||0.92|TWO_SIDED|95.0|-8.0|8.86|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||8.86|-8.00|0.920
74012025|NCT01147744|147574795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.702||||0.528|TWO_SIDED|95.0|-5.7|11.11|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||11.11|-5.70|0.528
74012026|NCT01147744|147574795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.218||||0.776|TWO_SIDED|95.0|-9.6|7.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||7.17|-9.60|0.776
74012027|NCT01147744|147574795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.49||||0.081|TWO_SIDED|95.0|-0.92|15.9|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||15.90|-0.92|0.081
74012028|NCT01147744|147574795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.611||||0.403|TWO_SIDED|95.0|-4.87|12.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.09|-4.87|0.403
74012029|NCT01147744|147574796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005||||0.951|TWO_SIDED|95.0|-0.17|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.17|0.951
74012030|NCT01147744|147574796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166||||0.043|TWO_SIDED|95.0|-0.33|-0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.01|-0.33|0.043
74093967|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.42|2.5|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 18C: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.50|1.42|
74093968|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.8|||||TWO_SIDED|95.0|1.43|2.2|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 19A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.20|1.43|
74093969|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.17|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 19F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.06|1.17|
74093970|NCT00546572|147738984|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|3.7|||||TWO_SIDED|95.0|2.69|5.09|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 23F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||5.09|2.69|
74093971|NCT00546572|147738985|SUPERIORITY_OR_OTHER||difference in proportions|43.8|||||TWO_SIDED|95.0|37.4|49.9|||||Exact 2-sided CI (based on Chan and Zhang) for the difference in proportions, 13vPnC - 23vPS expressed as a percentage.|"Serotype 6A: difference in proportions, 13vPnC - 23vPS, expressed as a percentage.~Statistical significance was shown if the lower limit of the 95% CI for the difference in proportions (13vPnC - 23vPS) was \> 0."||49.9|37.4|
74012031|NCT01147744|147574796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.028||||0.734|TWO_SIDED|95.0|-0.19|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.13|-0.19|0.734
74093972|NCT00546572|147738986|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|9.6|||||TWO_SIDED|95.0|7.0|13.26|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|"Serotype 6A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2."||13.26|7.00|
74093973|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.1|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 1: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.10|0.85|
74012032|NCT01147744|147574796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003||||0.972|TWO_SIDED|95.0|-0.16|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.16|0.972
74012033|NCT01147744|147574796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.097||||0.238|TWO_SIDED|95.0|-0.26|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.26|0.238
74012034|NCT01147744|147574796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075||||0.36|TWO_SIDED|95.0|-0.24|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.24|0.360
74012035|NCT01147744|147574797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028||||0.692|TWO_SIDED|95.0|-0.11|0.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.17|-0.11|0.692
74012036|NCT01147744|147574797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096||||0.176|TWO_SIDED|95.0|-0.24|0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.04|-0.24|0.176
74012037|NCT01147744|147574797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021||||0.768|TWO_SIDED|95.0|-0.16|0.12|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.12|-0.16|0.768
74042311|NCT04532918|147636406|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|80.99|||||TWO_SIDED|90.0|63.88|102.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for allopurinol||102.7|63.88|
74042312|NCT04532918|147636406|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|96.86|||||TWO_SIDED|90.0|92.11|101.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for oxypurinol||101.8|92.11|
74042313|NCT04532918|147636406|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|99.07|||||TWO_SIDED|90.0|94.36|104.0|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for oxypurinol||104.0|94.36|
74042314|NCT04532918|147636407|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.29|||||TWO_SIDED|90.0|91.26|105.9|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for allopurinol||105.9|91.26|
74042315|NCT04532918|147636407|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|101.2|||||TWO_SIDED|90.0|93.72|109.2|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for allopurinol||109.2|93.72|
74042316|NCT04532918|147636407|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|99.16|||||TWO_SIDED|90.0|95.02|103.5|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for oxypurinol||103.5|95.02|
74042317|NCT04532918|147636407|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|96.05|||||TWO_SIDED|90.0|92.15|100.1|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for oxypurinol||100.1|92.15|
74042318|NCT04532918|147636408|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.25|||||TWO_SIDED|90.0|91.1|106.0|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for allopurinol||106.0|91.10|
74093974|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.11|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 3: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.11|0.91|
74042319|NCT04532918|147636408|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|101.6|||||TWO_SIDED|90.0|93.99|109.8|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for allopurinol||109.8|93.99|
74042320|NCT04532918|147636408|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.05|||||TWO_SIDED|90.0|94.5|101.7|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for oxypurinol||101.7|94.50|
74042321|NCT04532918|147636408|OTHER||Geometric Mean Ratio (%)|95.98|||||TWO_SIDED|90.0|92.61|99.48|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects||99.48|92.61|
74093975|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.68|0.92|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 4: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||0.92|0.68|
74012038|NCT01147744|147574797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.887|TWO_SIDED|95.0|-0.13|0.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.15|-0.13|0.887
74012039|NCT01147744|147574797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.051||||0.471|TWO_SIDED|95.0|-0.19|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.19|0.471
74042322|NCT02564029|147636421|OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-8.6|-3.86|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-3.86|-8.60|
73879676|NCT03192176|147297615|SUPERIORITY||LSMean difference|25.7|STANDARD_ERROR_OF_MEAN|7.01||0.0003|TWO_SIDED|95.0|11.96|39.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||39.53|11.96|0.0003
73879677|NCT03192176|147297615|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|7.55||0.0078|TWO_SIDED|95.0|5.36|35.07||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||35.07|5.36|0.0078
74042323|NCT02564029|147636421|OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-7.78|-3.06|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-3.06|-7.78|
74042324|NCT02564029|147636421|OTHER||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-7.6|-2.84|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-2.84|-7.60|
74042325|NCT02564029|147636421|OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.58|3.2|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||3.20|-1.58|
74042326|NCT02564029|147636421|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-3.43|1.41|||Mixed Model Repreated Measure Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||1.41|-3.43|
74042327|NCT02564029|147636421|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-2.56|2.16|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||2.16|-2.56|
74042328|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-8.6|-3.86|||Mixed Model Repeated Measure Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.86|-8.60|
74042329|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-7.78|-3.06|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.06|-7.78|
74042330|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-7.6|-2.84|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-2.84|-7.60|
74042331|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.58|3.2|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||3.20|-1.58|
74042332|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-3.43|1.41|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.41|-3.43|
74042333|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-2.56|2.16|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||2.16|-2.56|
74042334|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-6.51|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|90.0|-8.01|-5.01|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-5.01|-8.01|
74042335|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-6.44|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|90.0|-7.93|-4.95|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-4.95|-7.93|
73879678|NCT03192176|147297615|SUPERIORITY||LSMean difference|28.3|STANDARD_ERROR_OF_MEAN|7.59||0.0002|TWO_SIDED|95.0|13.36|43.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||43.22|13.36|0.0002
73887997|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7878|TWO_SIDED|95.0|-2.6|3.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.5|-2.6|0.7878
74012040|NCT01147744|147574797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083||||0.248|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.22|0.248
74012041|NCT01147744|147574798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.131||||0.209|TWO_SIDED|95.0|-0.33|0.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.07|-0.33|0.209
74042336|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-5.74|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-7.2|-4.28|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-4.28|-7.20|
74042337|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|90.0|-1.31|1.46|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.46|-1.31|
74042338|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|-2.19|0.65|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||0.65|-2.19|
74042339|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|90.0|-2.09|0.7|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||0.70|-2.09|
74042340|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|90.0|-5.6|-3.25|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.25|-5.60|
74042341|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-5.57|-3.17|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.17|-5.57|
74042342|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-5.57|-3.19|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.19|-5.57|
74042343|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|90.0|-1.08|1.19|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.19|-1.08|
74012042|NCT01147744|147574798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.264||||0.011|TWO_SIDED|95.0|-0.47|-0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.06|-0.47|0.011
74042344|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|90.0|-1.18|1.1|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.10|-1.18|
74042345|NCT02564029|147636422|OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|-1.11|1.13|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.13|-1.11|
74042346|NCT00617656|147636449|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.56|TWO_SIDED|95.0|0.76|1.67|||Log Rank|||This is a futility analysis. The initial hypothesis of the clinical trial was that the experimental group as a whole was superior to the control group.||1.67|0.76|0.56
74042347|NCT00617656|147636449|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.79|TWO_SIDED|95.0|0.73|1.51|||Log Rank|||||1.51|0.73|0.79
74012043|NCT01147744|147574798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.076||||0.464|TWO_SIDED|95.0|-0.28|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.13|-0.28|0.464
74042348|NCT00617656|147636449|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.0001|TWO_SIDED|95.0|1.38|2.95|||Log Rank|||||2.95|1.38|0.0001
74042349|NCT00617656|147636450|SUPERIORITY||Hazard Ratio (HR)|1.55||||0.006|TWO_SIDED|95.0|1.13|2.12|||Log Rank|||||2.12|1.13|0.006
74042350|NCT05441540|147636469|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74042351|NCT05441540|147636470|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74042352|NCT05441540|147636471|OTHER|||||||0.7613|||||||Kruskal-Wallis|||||||0.7613
74042353|NCT05441540|147636472|OTHER|||||||0.764|||||||Wilcoxon (Mann-Whitney)|||||||0.7640
74042354|NCT00879437|147636486|NON_INFERIORITY|if 19 evaluable patients enrolled for DIPG, study is powered at 80% to detect a 20% improvement in 1-year EFS compared to historical control if 21 evaluable patients enrolled for HGG, study is powered at 80% to detect a 20% improvement in 1-year EFS compared to historical control|||||<|0.05|||||||Log Rank|one sample log-rank||comparing 1-year EFS of DIPG on this trial versus historical control (1-year EFS of 17% from CCG-9941; PMID 12177103) comparing 1-year EFS of HGG on this trial versus historical control (1-year EFS of 36% from ACNS0126; PMID 21339192)||||< 0.05
74042355|NCT00879437|147636526|OTHER|The Kaplan-Meier method was used to estimate the median EFS for each cohort with 95% confidence intervals. All analyses were performed in SAS version 9.4 statistical software (SAS Institute Inc) and R (https://cran.r-project.org/).|||||||TWO_SIDED|95.0|||||||||The Kaplan-Meier method was used to estimate the median EFS for each cohort with 95% confidence intervals.|||
74012044|NCT01147744|147574798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045||||0.662|TWO_SIDED|95.0|-0.25|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.25|0.662
74012045|NCT01147744|147574798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245||||0.018|TWO_SIDED|95.0|-0.45|-0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.04|-0.45|0.018
74012046|NCT01147744|147574798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.207||||0.047|TWO_SIDED|95.0|-0.41|0.0|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.00|-0.41|0.047
73879679|NCT03192176|147297615|SUPERIORITY||LSMean difference|36.9|STANDARD_ERROR_OF_MEAN|7.55|<|0.0001|TWO_SIDED|95.0|22.07|51.77||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||51.77|22.07|<0.0001
73879680|NCT03192176|147297615|SUPERIORITY||LSMean difference|40.5|STANDARD_ERROR_OF_MEAN|7.69|<|0.0001|TWO_SIDED|95.0|25.41|55.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRm|||Week 3||55.67|25.41|<0.0001
73879681|NCT03192176|147297615|SUPERIORITY||LSMean difference|19.7|STANDARD_ERROR_OF_MEAN|7.7||0.0108|TWO_SIDED|95.0|4.59|34.88||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||34.88|4.59|0.0108
74012047|NCT01147744|147574799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.098||||0.3|TWO_SIDED|95.0|-0.28|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.28|0.300
74012048|NCT01147744|147574799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.138||||0.145|TWO_SIDED|95.0|-0.32|0.05|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.05|-0.32|0.145
74012049|NCT01147744|147574799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.123||||0.19|TWO_SIDED|95.0|-0.31|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.31|0.190
74012050|NCT01147744|147574799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002||||0.98|TWO_SIDED|95.0|-0.19|0.18|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.18|-0.19|0.980
74012051|NCT01147744|147574799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.171||||0.07|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.01|-0.36|0.070
74012052|NCT01147744|147574799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.158||||0.095|TWO_SIDED|95.0|-0.34|0.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.03|-0.34|0.095
74012053|NCT01147744|147574800|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
74012054|NCT01147744|147574800|SUPERIORITY_OR_OTHER|||||||0.814|||||||Fisher Exact|||||||0.814
74012055|NCT01147744|147574800|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
74012056|NCT01147744|147574800|SUPERIORITY_OR_OTHER|||||||0.828|||||||Fisher Exact|||||||0.828
74012057|NCT01147744|147574800|SUPERIORITY_OR_OTHER|||||||0.477|||||||Fisher Exact|||||||0.477
74042356|NCT00879437|147636527|OTHER|The Kaplan-Meier method was used to estimate the one-year EFS for each cohort with 95% confidence intervals. All analyses were performed in SAS version 9.4 statistical software (SAS Institute Inc) and R (https://cran.r-project.org/).|||||||TWO_SIDED|95.0|||||||||The Kaplan-Meier method was used to estimate the one-year EFS for each cohort with 95% confidence intervals.|||
74012058|NCT01147744|147574800|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.460
74012059|NCT01342484|147574802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.48||0.3295|TWO_SIDED|95.0|-1.47|0.51|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, pharmacokinetic (PK) / pharmacodynamics (PD) subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.51|-1.47|0.3295
74012060|NCT01342484|147574802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63|STANDARD_ERROR_OF_MEAN|0.42||0.1447|TWO_SIDED|95.0|-1.5|0.23|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.23|-1.50|0.1447
74012061|NCT01342484|147574804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|1.36||0.8216|TWO_SIDED|95.0|-3.08|2.46|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||2.46|-3.08|0.8216
74012062|NCT01342484|147574804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|1.18||0.1189|TWO_SIDED|95.0|-4.31|0.52|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.52|-4.31|0.1189
74012063|NCT03302975|147574851|SUPERIORITY|||||||0.001|TWO_SIDED|95.0|||||ANOVA|||||||0.001
74042357|NCT00879437|147636528|OTHER|||||||||||||||||partial response defined as 51% to 99% reduction in tumor size,determined using WHO bi-dimensional criteria (product of the greatest tumor diameter and its perpendicular diameter)|Not applicable (8 partial responses in 16 patients = 50%)|||
73879682|NCT03192176|147297615|SUPERIORITY||LSMean difference|25.0|STANDARD_ERROR_OF_MEAN|7.56||0.0011|TWO_SIDED|95.0|10.09|39.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||39.84|10.09|0.0011
73879683|NCT03192176|147297615|SUPERIORITY||LSMean difference|30.9|STANDARD_ERROR_OF_MEAN|7.53|<|0.0001|TWO_SIDED|95.0|16.03|45.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||45.67|16.03|<0.0001
73879684|NCT03192176|147297615|SUPERIORITY||LSMean difference|20.5|STANDARD_ERROR_OF_MEAN|7.47||0.0063|TWO_SIDED|95.0|5.84|35.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||35.23|5.84|0.0063
73879685|NCT03192176|147297615|SUPERIORITY||LSMean difference|28.7|STANDARD_ERROR_OF_MEAN|7.49||0.0002|TWO_SIDED|95.0|13.98|43.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||43.46|13.98|0.0002
73879686|NCT03192176|147297615|SUPERIORITY||LSMean difference|33.3|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|18.66|48.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||48.00|18.66|<0.0001
73879687|NCT03192176|147297615|SUPERIORITY||LSMean difference|41.5|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|26.52|56.41||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||56.41|26.52|<0.0001
74012064|NCT02258451|147574858|SUPERIORITY||Hazard Ratio (HR)|0.891||||0.4843|TWO_SIDED|80.0|0.72|1.102||1-sided SSE-FS hypotheses were tested using a log-rank test with a 2-sided alpha of 0.2, stratified by the randomization stratification factors.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) for SSE-FS was calculated using Cox Proportional Hazards Model, stratified by the same stratification factors as randomization.|The 1-sided null hypothesis that treatment with radium-223 dichloride does not result in superior SSE-FS to treatment with placebo in participant population was tested against the 1-sided alternative hypothesis that the treatment with radium-223 dichloride results in superior SSE-FS time to treatment the placebo. H0: SSE-FS Radium-223+Exemestane/Everolimus \<= SSE-FS Placebo+Exemestane/Everolimus, versus HA: SSE-FSRadium-223+Exemestane/Everolimus \> SSE-FS Placebo+Exemestane/Everolimus||1.102|0.720|0.4843
74012065|NCT02258451|147574859|SUPERIORITY||Hazard Ratio (HR)|0.968||||0.8438|TWO_SIDED|95.0|0.697|1.343||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.343|0.697|0.8438
74012066|NCT02258451|147574860|SUPERIORITY||Hazard Ratio (HR)|0.962||||0.8811|TWO_SIDED|95.0|0.577|1.604||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.604|0.577|0.8811
74012067|NCT02258451|147574861|SUPERIORITY||Hazard Ratio (HR)|0.928||||0.6537|TWO_SIDED|95.0|0.667|1.289||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|Participants with baseline WPS \> 8 were included in the analysis population but censored at Day 1.||1.289|0.667|0.6537
74012068|NCT02258451|147574862|SUPERIORITY||Hazard Ratio (HR)|0.884||||0.4496|TWO_SIDED|95.0|0.641|1.219||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.219|0.641|0.4496
74012069|NCT02258451|147574863|SUPERIORITY||Hazard Ratio (HR)|0.874||||0.3467|TWO_SIDED|95.0|0.66|1.157||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.157|0.660|0.3467
74042358|NCT03000686|147636531|OTHER||Median Difference (Net)|0.021|STANDARD_DEVIATION|1.1339|||TWO_SIDED|95.0|-2.249|2.295|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion|||2.295|-2.249|
74042359|NCT03000686|147636531|OTHER||Median Difference (Net)|-4.021|STANDARD_DEVIATION|2.5923|||TWO_SIDED|95.0|-9.168|1.146|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.|||1.146|-9.168|
73879688|NCT03192176|147297615|SUPERIORITY||LSMean difference|19.7|STANDARD_ERROR_OF_MEAN|7.59||0.0098|TWO_SIDED|95.0|4.78|34.66||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||34.66|4.78|0.0098
73879689|NCT03192176|147297615|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|15.26|44.61||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||44.61|15.26|<0.0001
73879690|NCT03192176|147297615|SUPERIORITY||LSMean difference|33.1|STANDARD_ERROR_OF_MEAN|7.43|<|0.0001|TWO_SIDED|95.0|18.5|47.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||47.73|18.50|<0.0001
74012070|NCT02258451|147574864|SUPERIORITY||Risk Difference (RD)|4.1||||0.556|TWO_SIDED|95.0|-10.2|18.4||P-value was calculated using a 2-sided Cochran-Mantel-Haenszel test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Cochran-Mantel-Haenszel|||||18.4|-10.2|0.556
74093976|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.73|0.94|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 5: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||0.94|0.73|
74012071|NCT03834519|147574883|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2616|TWO_SIDED|95.0|0.77|1.14|||Log Rank|One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|Treatment difference in survival assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.||1.14|0.77|0.2616
74012072|NCT03834519|147574884|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.5544|TWO_SIDED|95.0|0.82|1.25|||Log Rank|One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|Treatment difference in rPFS assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.||1.25|0.82|0.5544
74012073|NCT03834519|147574885|OTHER|Treatment difference in TFST|Hazard Ratio (HR)|0.86||||||95.0|0.71|1.03|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.03|0.71|
74012074|NCT03834519|147574886|OTHER|Treatment difference in ORR|Difference in percentage|10.9|||||TWO_SIDED|95.0|4.0|17.1||||||||17.1|4.0|
74012075|NCT03834519|147574888|OTHER|Treatment difference in time to PSA progression|Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.89|1.38|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.38|0.89|
74012076|NCT03834519|147574889|OTHER|Treatment difference in SSRE|Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.38|0.78|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||0.78|0.38|
74012077|NCT03834519|147574890|OTHER|Treatment difference in time to radiographic soft tissue progression|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.62|1.0|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.00|0.62|
74012078|NCT03834519|147574891|OTHER|Treatment difference in TTPE|Hazard Ratio (HR)|0.95||||0.3643|TWO_SIDED|95.0|0.72|1.26|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.26|0.72|0.3643
74012079|NCT00980200|147574921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|||<|0.001|TWO_SIDED|95.0|0.049|0.14|||ANCOVA|||||0.140|0.049|<0.001
74012080|NCT00980200|147574921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.095|0.185|||ANCOVA|||||0.185|0.095|<0.001
74012081|NCT00980200|147574921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||<|0.001|TWO_SIDED|95.0|0.057|0.147|||ANCOVA|||||0.147|0.057|<0.001
74012082|NCT00980200|147574921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|||<|0.001|TWO_SIDED|95.0|0.08|0.17|||ANCOVA|||||0.170|0.080|<0.001
74012083|NCT00457015|147574923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The primary efficacy analysis compared the change from baseline in MSCS Score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.010
74012084|NCT00457015|147574924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.003
74012085|NCT00457015|147574925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||Kaplan-Meier analysis using the Log-Rank test was used to compare the time distribution between the 2 treatment groups.||||0.102
74012086|NCT01999465|147574999|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|We applied Wilcoxon-Mann Whitney test with the Null hypothesis that there is no difference between 2 arms.||||||0.40
74012087|NCT01999465|147575000|OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
74012088|NCT01308008|147575034|SUPERIORITY||coefficient|0.05||||0.16|TWO_SIDED|95.0|-0.02|0.13|||Regression, Logistic|||||0.13|-0.02|0.16
74012089|NCT01308008|147575035|SUPERIORITY||coefficient|34.0||||0.17|TWO_SIDED|95.0|-15.0|83.0|||Regression, Logistic|||||83|-15|0.17
74012090|NCT01308008|147575036|SUPERIORITY||coefficient|-8.7||||0.5|TWO_SIDED|95.0|-35.0|17.0|||Regression, Logistic|||||17|-35|0.5
73879691|NCT03192176|147297615|SUPERIORITY||LSMean difference|15.4|STANDARD_ERROR_OF_MEAN|7.1||0.0303|TWO_SIDED|95.0|1.48|29.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||29.40|1.48|0.0303
73879692|NCT03192176|147297615|SUPERIORITY||LSMean difference|24.8|STANDARD_ERROR_OF_MEAN|7.11||0.0006|TWO_SIDED|95.0|10.77|38.74||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||38.74|10.77|0.0006
73879693|NCT03192176|147297615|SUPERIORITY||LSMean difference|30.8|STANDARD_ERROR_OF_MEAN|7.11|<|0.0001|TWO_SIDED|95.0|16.77|44.75||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||44.75|16.77|<0.0001
73879694|NCT03192176|147297615|SUPERIORITY||LSMean difference|38.8|STANDARD_ERROR_OF_MEAN|7.23|<|0.0001|TWO_SIDED|95.0|24.55|53.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||53.00|24.55|<0.0001
73879695|NCT03192176|147297615|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|7.2||0.0086|TWO_SIDED|95.0|4.88|33.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||33.23|4.88|0.0086
73879696|NCT03192176|147297615|SUPERIORITY||LSMean difference|22.3|STANDARD_ERROR_OF_MEAN|7.09||0.0018|TWO_SIDED|95.0|8.33|36.24||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||36.24|8.33|0.0018
73879697|NCT03192176|147297615|SUPERIORITY||LSMean difference|25.1|STANDARD_ERROR_OF_MEAN|7.07||0.0004|TWO_SIDED|95.0|11.24|39.05||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||39.05|11.24|0.0004
73879698|NCT03192176|147297615|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.62||0.0282|TWO_SIDED|95.0|1.56|27.6||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||27.60|1.56|0.0282
74012091|NCT03357731|147575037|SUPERIORITY||Mean Difference (Net)|-2.15|STANDARD_ERROR_OF_MEAN|0.9242||0.027|TWO_SIDED|95.0|-4.0432|-0.257|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||-0.2570|-4.0432|0.027
74012092|NCT03357731|147575038|SUPERIORITY||Mean Difference (Net)|0.193|STANDARD_ERROR_OF_MEAN|0.9832||0.846|TWO_SIDED|95.0|-1.8176|2.2042|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||2.2042|-1.8176|0.846
74012093|NCT03357731|147575039|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|0.93||0.177|TWO_SIDED|95.0|-0.62|3.19|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||3.19|-0.62|0.177
74012094|NCT03357731|147575039|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.48||0.839|TWO_SIDED|95.0|-1.08|0.88|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.88|-1.08|0.839
73879699|NCT03192176|147297615|SUPERIORITY||LSMean difference|19.9|STANDARD_ERROR_OF_MEAN|6.63||0.0029|TWO_SIDED|95.0|6.85|32.92||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||32.92|6.85|0.0029
73879700|NCT03192176|147297615|SUPERIORITY||LSMean difference|29.7|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|16.58|42.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||42.73|16.58|<0.0001
73879701|NCT03192176|147297615|SUPERIORITY||LSMean difference|35.7|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|95.0|22.42|48.99||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||48.99|22.42|<0.0001
73887998|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0019|TWO_SIDED|95.0|5.6|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.0|5.6|0.0019
74012095|NCT03357731|147575040|SUPERIORITY||Mean Difference (Net)|-0.0977|STANDARD_ERROR_OF_MEAN|0.03308||0.007|TWO_SIDED|95.0|-0.16634|-0.02915|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||-0.02915|-0.16634|0.007
74042360|NCT03000686|147636531|OTHER||Median Difference (Net)|-1.668|STANDARD_DEVIATION|4.4927|||TWO_SIDED|95.0|-10.576|7.231|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for immediately post-exercise|||7.231|-10.576|
73879702|NCT03192176|147297615|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.74||0.0304|TWO_SIDED|95.0|1.4|27.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||27.90|1.40|0.0304
73879703|NCT03192176|147297615|SUPERIORITY||LSMean difference|20.4|STANDARD_ERROR_OF_MEAN|6.64||0.0022|TWO_SIDED|95.0|7.38|33.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||33.50|7.38|0.0022
73879704|NCT03192176|147297615|SUPERIORITY||LSMean difference|26.5|STANDARD_ERROR_OF_MEAN|6.59|<|0.0001|TWO_SIDED|95.0|13.56|39.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||39.50|13.56|<0.0001
74042361|NCT03000686|147636531|OTHER||Median Difference (Net)|-0.824|STANDARD_DEVIATION|1.6695|||TWO_SIDED|95.0|-4.142|2.506|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit|||2.506|-4.142|
74042362|NCT03000686|147636532|OTHER||Median Difference (Net)|-0.662|STANDARD_DEVIATION|2.1933|||TWO_SIDED|95.0|-5.037|3.815|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion|||3.815|-5.037|
74042363|NCT03000686|147636532|OTHER||Median Difference (Net)|-2.796|STANDARD_DEVIATION|3.4297|||TWO_SIDED|95.0|-9.729|4.027|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.|||4.027|-9.729|
74042364|NCT03000686|147636532|OTHER||Median Difference (Net)|-0.018|STANDARD_DEVIATION|4.145|||TWO_SIDED|95.0|-8.475|8.086|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 2 minutes post-exercise start|||8.086|-8.475|
74042365|NCT03000686|147636532|OTHER||Median Difference (Net)|-0.291|STANDARD_DEVIATION|2.3277|||TWO_SIDED|95.0|-4.96|4.386|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit|||4.386|-4.960|
74042366|NCT03000686|147636539|OTHER||Median Difference (Net)|-0.148|STANDARD_DEVIATION|0.5622|||TWO_SIDED|95.0|-1.264|0.973|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.|||0.973|-1.264|
74042367|NCT03000686|147636539|OTHER||Median Difference (Net)|-1.172|STANDARD_DEVIATION|2.072|||TWO_SIDED|95.0|-5.271|2.942|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.|||2.942|-5.271|
74042368|NCT03000686|147636539|OTHER||Median Difference (Net)|-0.169|STANDARD_DEVIATION|2.2351|||TWO_SIDED|95.0|-4.624|4.258|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation immediately post-exercise is presented.|||4.258|-4.624|
74042369|NCT03000686|147636539|OTHER||Median Difference (Net)|-0.367|STANDARD_DEVIATION|0.5649|||TWO_SIDED|95.0|-1.498|0.753|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.|||0.753|-1.498|
74042370|NCT03000686|147636540|OTHER||Median Difference (Net)|0.203|STANDARD_DEVIATION|0.8872|||TWO_SIDED|95.0|-1.578|1.968|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.|||1.968|-1.578|
74042371|NCT03000686|147636540|OTHER||Median Difference (Net)|3.76|STANDARD_DEVIATION|1.8799|||TWO_SIDED|95.0|-0.001|7.495|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.|||7.495|-0.001|
74042372|NCT03000686|147636540|OTHER||Median Difference (Net)|-1.029|STANDARD_DEVIATION|2.8146|||TWO_SIDED|95.0|-6.673|4.578|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 2 minutes post-exercise start is presented.|||4.578|-6.673|
74042373|NCT03000686|147636540|OTHER||Median Difference (Net)|-0.873|STANDARD_DEVIATION|0.762|||TWO_SIDED|95.0|-2.38|0.669|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.|||0.669|-2.380|
74042374|NCT01112982|147636578|OTHER|||||||0.34|||||||t-test, 2 sided|||Presence of synovial pannus and the serum urate level.||||0.34
74042375|NCT01112982|147636580|OTHER|Spearman Correlation Coefficient||||||0.73|||||||t-test, 1 sided|||The Severity of Synovial Pannus and the Serum Urate level.||||0.73
74042376|NCT01112982|147636581|OTHER|correlation between severity of synovial pannus and the serum urate level.||||||0.73|||||||t-test, 1 sided|||||||0.73
74042377|NCT01112982|147636582|OTHER|||||||0.32||||||"The presence of synovial pannus in the index joint."|t-test, 1 sided|||||||0.32
74042378|NCT01112982|147636583|OTHER|Kappa Coefficient||||||0.09|||||||t-test, 2 sided|||The absence of erosive changes.||||0.09
74042379|NCT01112982|147636583|OTHER|the absence of Intraosseous Tophi.||||||0.33|||||||t-test, 2 sided|||||||0.33
74042380|NCT01112982|147636583|OTHER|The absence of Soft Tissue Tophi||||||0.09|||||||t-test, 2 sided|||||||0.09
74042381|NCT01112982|147636583|OTHER|The absence of Joint Effusion.||||||0.31|||||||t-test, 2 sided|||||||0.31
74042382|NCT01112982|147636583|OTHER|The absence of Bone Marrow Edema.||||||0.25|||||||t-test, 2 sided|||||||0.25
74042383|NCT01112982|147636583|OTHER|The absence of Soft Tissue Edema.||||||0.14|||||||t-test, 2 sided|||||||0.14
74042384|NCT01112982|147636584|OTHER|||||||0.32||||||"The Presence of synovial Pannus in the index joint."|t-test, 1 sided|||||||0.32
74042385|NCT01112982|147636584|OTHER|||||||0.99||||||"The Severity of Synovial Pannus in the index joint."|t-test, 1 sided|||||||0.99
74042386|NCT00294684|147636585|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14||||0.43|TWO_SIDED|95.0|0.83|1.57|||Log binomial|||RR greater than one indicates benefit of steriods and a P value of treatment success from a log-binomial model with these covariates: Treatment group, age a HPE, BASM as fixed effects, and site as a random effect.||1.57|0.83|0.43
74042387|NCT00294684|147636586|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.6|1.8|||Regression, Cox|||||1.8|0.6|0.99
74042388|NCT00294684|147636587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6||||0.0973|TWO_SIDED|95.0|-3.49|0.3|||Mixed Models Analysis|||LS Mean difference reported as steroid minus placebo (negative values mean larger average values of total bilirubin in placebo).||0.3|-3.49|0.0973
74012096|NCT03357731|147575040|SUPERIORITY||Mean Difference (Net)|-0.0371|STANDARD_ERROR_OF_MEAN|0.02194||0.103|TWO_SIDED|95.0|-0.08243|0.00814|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.00814|-0.08243|0.103
74012097|NCT03357731|147575041|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.037||0.003|TWO_SIDED|95.0|-0.205|-0.051|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/A ratio||-0.051|-0.205|0.003
74012098|NCT03357731|147575041|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.904|TWO_SIDED|95.0|-0.051|0.057|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/A ratio||0.057|-0.051|0.904
74012099|NCT03357731|147575041|SUPERIORITY||Mean Difference (Net)|-1.66|STANDARD_ERROR_OF_MEAN|0.527||0.006|TWO_SIDED|95.0|-2.763|-0.549|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/e' ratio||-0.549|-2.763|0.006
74012100|NCT03357731|147575041|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.392||0.503|TWO_SIDED|95.0|-1.085|0.55|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/e' ratio||0.550|-1.085|0.503
74012101|NCT03357731|147575042|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.398||0.994|TWO_SIDED|95.0|-0.827|0.82|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|annular e' velocity||0.820|-0.827|0.994
74012102|NCT03357731|147575042|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_ERROR_OF_MEAN|0.258||0.073|TWO_SIDED|95.0|-0.049|1.013|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|annular e' velocity||1.013|-0.049|0.073
74012103|NCT03357731|147575043|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.4||0.705|TWO_SIDED|95.0|-0.67|0.976|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.976|-0.670|0.705
74012104|NCT03357731|147575043|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.404||0.105|TWO_SIDED|95.0|-1.504|0.151|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.151|-1.504|0.105
74042389|NCT00294684|147636588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.3||||0.0552|TWO_SIDED|95.0|-4.65|0.05|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average values of bilirubin in placebo)||0.05|-4.65|0.0552
74012105|NCT01417195|147575044|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin for the lower limit of the 95% CI for the difference in fertilization rate was below -12%.|Mean Difference (Final Values)|3.6|||||TWO_SIDED|95.0|-4.3|11.5|||||"Mean difference = Menopur/Bravelle - Menopur.~95% CI is based on Student's t-distribution, assuming equal variances."|||11.5|-4.3|
74012106|NCT02819635|147575061|SUPERIORITY||Adjusted risk difference (%)|8.4||||0.049|TWO_SIDED|95.0|0.0|16.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||16.8|0.0|0.049
74012107|NCT02819635|147575061|SUPERIORITY||Adjusted risk difference (%)|13.5||||0.01|TWO_SIDED|95.0|3.3|23.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||23.8|3.3|0.010
74012108|NCT02819635|147575061|SUPERIORITY||Adjusted risk difference (%)|13.8||||0.007|TWO_SIDED|95.0|3.8|23.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||23.9|3.8|0.007
74012109|NCT02819635|147575061|SUPERIORITY||Adjusted risk difference (%)|21.1|||<|0.001|TWO_SIDED|95.0|8.6|33.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||33.6|8.6|<0.001
74042390|NCT00294684|147636589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.39||||0.6607||95.0|-2.16|1.38|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average bilirubin in placebo)||1.38|-2.16|0.6607
74042391|NCT00294684|147636590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1603|||||||Mixed Models Analysis|||||||0.1603
73879705|NCT03192176|147297615|SUPERIORITY||LSMean difference|14.4|STANDARD_ERROR_OF_MEAN|6.87||0.0362|TWO_SIDED|95.0|0.93|27.95||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||27.95|0.93|0.0362
74012110|NCT02819635|147575062|SUPERIORITY||Adjusted risk difference (%)|21.6|||<|0.001|TWO_SIDED|95.0|15.8|27.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes vs. no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||27.4|15.8|<0.001
74012111|NCT02819635|147575063|SUPERIORITY||Adjusted risk difference (%)|30.7|||<|0.001|TWO_SIDED|95.0|21.7|39.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||39.8|21.7|<0.001
74012112|NCT02819635|147575063|SUPERIORITY||Adjusted risk difference (%)|39.0|||<|0.001|TWO_SIDED|95.0|29.7|48.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||48.2|29.7|<0.001
74012113|NCT02819635|147575064|SUPERIORITY||Adjusted risk difference (%)|13.1||||0.03|TWO_SIDED|95.0|1.2|25.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||25.0|1.2|0.030
74012114|NCT02819635|147575064|SUPERIORITY||Adjusted risk difference (%)|27.6|||<|0.001|TWO_SIDED|95.0|13.1|42.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||42.1|13.1|<0.001
74012115|NCT02819635|147575064|SUPERIORITY||Adjusted risk difference (%)|26.6|||<|0.001|TWO_SIDED|95.0|12.3|40.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||40.8|12.3|<0.001
74012116|NCT02819635|147575064|SUPERIORITY||Adjusted risk difference (%)|35.4|||<|0.001|TWO_SIDED|95.0|19.2|51.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||51.7|19.2|<0.001
74012117|NCT02819635|147575065|SUPERIORITY||Adjusted risk difference (%)|11.0||||0.021|TWO_SIDED|95.0|1.7|20.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||20.4|1.7|0.021
74012118|NCT02819635|147575065|SUPERIORITY||Adjusted risk difference (%)|9.6||||0.024|TWO_SIDED|95.0|1.3|18.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||18.0|1.3|0.024
73879706|NCT03192176|147297615|SUPERIORITY||LSMean difference|22.9|STANDARD_ERROR_OF_MEAN|6.88||0.0009|TWO_SIDED|95.0|9.41|36.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.47|9.41|0.0009
74012119|NCT02819635|147575065|SUPERIORITY||Adjusted risk difference (%)|12.2||||0.015|TWO_SIDED|95.0|2.3|22.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||22.0|2.3|0.015
74012120|NCT02819635|147575065|SUPERIORITY||Adjusted risk difference (%)|20.1||||0.001|TWO_SIDED|95.0|8.0|32.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||32.1|8.0|0.001
74012121|NCT02819635|147575066|SUPERIORITY||Adjusted risk difference (%)|16.7||||0.038|TWO_SIDED|95.0|0.9|32.5||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||32.5|0.9|0.038
74012122|NCT02819635|147575066|SUPERIORITY||Adjusted risk difference (%)|35.2|||<|0.001|TWO_SIDED|95.0|17.5|52.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||52.8|17.5|<0.001
74042392|NCT00294684|147636591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2801|||||||Mixed Models Analysis|||||||0.2801
74042393|NCT00294684|147636592|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.4||||0.41|TWO_SIDED|95.0|0.62|3.14|||Log Binomial|||||3.14|0.62|0.41
74042394|NCT00294684|147636593|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.3||||0.29|TWO_SIDED|95.0|0.03|2.92|||Log Binomial|||||2.92|0.03|0.29
74042395|NCT00587834|147636609|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact Bionomial Test|||Superiority relative to a pre-defined standard (50% success)||||<0.0001
74042396|NCT00587834|147636610|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||McNemar|||Compare participants with (1) Gintuit equally red and Control not equally red to (2) Gintuit not equally red and Control equally red||||<0.0001
74042397|NCT00587834|147636611|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||McNemar|||Compare participants with (1)Gintuit equally firm and Control not equally firm to (2) Gintuit not equally firm and Control equally firm||||<0.0001
74012123|NCT02819635|147575066|SUPERIORITY||Adjusted risk difference (%)|33.6|||<|0.001|TWO_SIDED|95.0|16.3|50.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||50.8|16.3|<0.001
74042398|NCT00587834|147636612|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact binomial test|||Superiority relative to a pre-defined threshold (80%) success||||<0.0001
74042399|NCT00587834|147636613|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact binomial test|||The proportion of Gintuit as the preferred procedure.||||<0.0001
74042400|NCT00587834|147636614|SUPERIORITY_OR_OTHER|||||||0.3173||95.0|||||McNemar|McNemar's paired comparison test||Compare participants with (1) Gintuit not sensitive and Control sensitive to (2) Gintuit sensitive and Control not sensitive.||||0.3173
74042401|NCT01001234|147636633|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.025|TWO_SIDED|95.0|1.06|2.26||The statistical significance level for the primary endpoint was α=0.0477, and had been adjusted to account for the interim sample size adjustment.|Regression, Logistic|Testing of primary endpoint and secondary endpoints was conducted sequentially in a pre-specified order, thus strongly controlling Type I error.||The comparison of rizatriptan versus placebo with respect to the primary outcome was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (United States \[US\] or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||2.26|1.06|0.025
73887999|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.821|TWO_SIDED|95.0|-8.1|10.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.3|-8.1|0.821
74042402|NCT01001234|147636634|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|95.0|0.96|1.9||Secondary endpoints were to be formally tested only if the test of the primary endpoint was statistically significant at the α=0.0477 level. The secondary endpoints were then tested sequentially in a pre-specified order, each at the α=0.05 level.|Regression, Logistic|This first secondary hypothesis was not statistically significant, therefore the other two were not formally tested for statistical significance.||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 12 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||1.90|0.96|0.080
74042403|NCT01001234|147636635|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.01|TWO_SIDED|95.0|1.1|2.1||This second secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain freedom at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||2.10|1.10|0.010
74042404|NCT01001234|147636636|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.178|TWO_SIDED|95.0|0.91|1.63||This third secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||1.63|0.91|0.178
74042405|NCT00753623|147636651|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
74042406|NCT03332303|147636652|EQUIVALENCE|If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Responders in the Test and Reference groups (pT - pR) is contained within the range \[-20%, +20%\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated.|Mean Difference (Final Values)|-5.1|||||TWO_SIDED|90.0|-13.0|2.8||||||Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.||2.8|-13.0|
74042407|NCT03332303|147636652|SUPERIORITY||% Difference|23.4|||<|0.0001|TWO_SIDED|||||The a priori threshold for statistical significance is p \< 0.05.|Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||<0.0001
74042408|NCT03332303|147636652|SUPERIORITY||% Difference|28.7|||<|0.0001|TWO_SIDED|||||The a priori threshold for statistical significance is p \< 0.05.|Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||<0.0001
74042409|NCT03332303|147636653|EQUIVALENCE|If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Treatment Successes in the Test and Reference groups (pT - pR) is contained within the range \[-20%, +20%\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated.|Mean Difference (Final Values)|-2.0|||||TWO_SIDED|90.0|-10.7|6.7||||||Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.||6.7|-10.7|
74042410|NCT03332303|147636653|SUPERIORITY|To conclude superiority of the Test product over Placebo, the proportion of Treatment Successes in the Test product group must be numerically and statistically superior to that of the Placebo (p \< 0.05; using a two-sided Cochran-Mantel-Haenszel \[CMH\] test).|% Difference|-0.8||||0.8068|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||0.8068
74042411|NCT03332303|147636653|SUPERIORITY|To conclude superiority of the Reference product over Placebo, the proportion of Treatment Successes in the Reference product group must be numerically and statistically superior to that of the Placebo (p \< 0.05; using a two-sided Cochran-Mantel-Haenszel \[CMH\] test).|% Difference|1.8||||0.8003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||0.8003
74042412|NCT02157168|147636690|SUPERIORITY|||||||0.624||||||This comparison reflects intent to treat and is the main comparison in the study.|Chi-squared|||CG and IG (IG1+IG2)||||0.624
74042413|NCT02157168|147636690|SUPERIORITY|||||||0.001||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.001
74042414|NCT02157168|147636691|SUPERIORITY|||||||0.278||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.278
74042415|NCT02157168|147636691|SUPERIORITY|||||||0.056||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.056
74042416|NCT02157168|147636692|SUPERIORITY|||||||0.889||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.889
74042417|NCT02157168|147636692|SUPERIORITY|||||||0.691||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.691
74042418|NCT02157168|147636693|SUPERIORITY|||||||0.741||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.741
74042419|NCT02157168|147636693|SUPERIORITY|||||||0.966||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.966
74042420|NCT02157168|147636694|SUPERIORITY|||||||0.117||||||This comparison captures the change over the intervention period.|Chi-squared|||||||.117
73888000|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.0094|TWO_SIDED|95.0|3.1|21.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.5|3.1|0.0094
74042421|NCT02157168|147636694|SUPERIORITY|||||||0.638||||||This comparison is an indication of whether the change seen between baseline and 6 months in the IG1 was due to the intervention or simply due to 6 months' enrollment.|Chi-squared|||||||.638
74042422|NCT03418051|147636719|SUPERIORITY|||||||0.824||||||A priori alpha level was set to 0.05|ANOVA|||||||0.824
74042423|NCT03418051|147636719|SUPERIORITY|||||||0.426||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.426
74042424|NCT03418051|147636720|SUPERIORITY|||||||0.722||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.722
74012124|NCT02819635|147575066|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|26.2|63.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||63.9|26.2|<0.001
74012125|NCT02819635|147575067|SUPERIORITY||Adjusted risk difference (%)|5.9||||0.495|TWO_SIDED|95.0|-11.1|22.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||22.9|-11.1|0.495
74012126|NCT02819635|147575067|SUPERIORITY||Adjusted risk difference (%)|15.9||||0.074|TWO_SIDED|95.0|-1.6|33.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||33.4|-1.6|0.074
74012127|NCT02819635|147575067|SUPERIORITY||Adjusted risk difference (%)|19.2||||0.033|TWO_SIDED|95.0|1.6|36.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||36.9|1.6|0.033
74012128|NCT02819635|147575067|SUPERIORITY||Adjusted risk difference (%)|40.1|||<|0.001|TWO_SIDED|95.0|20.5|59.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||59.7|20.5|<0.001
74012129|NCT02819635|147575068|SUPERIORITY||LS Mean Difference|-2.142|||<|0.001|TWO_SIDED|95.0|-3.2323|-1.052||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||-1.0520|-3.2323|<0.001
74042425|NCT03418051|147636720|SUPERIORITY|||||||0.843||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.843
74042426|NCT03418051|147636721|SUPERIORITY|||||||0.046||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.046
74042427|NCT03418051|147636721|SUPERIORITY|||||||0.845||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.845
74042428|NCT03418051|147636722|SUPERIORITY|||||||0.138||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.138
74042429|NCT03418051|147636722|SUPERIORITY|||||||0.523||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.523
74093977|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.4|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.40|1.03|
74042430|NCT03418051|147636723|SUPERIORITY|||||||0.069||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.069
74042431|NCT03418051|147636723|SUPERIORITY|||||||0.413||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.413
74042432|NCT03418051|147636724|SUPERIORITY|||||||0.604||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.604
74042433|NCT03418051|147636724|SUPERIORITY|||||||0.499||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.499
74042434|NCT03418051|147636725|SUPERIORITY|||||||0.005||||||A priori threshold was set at 0.05.|ANOVA|||||||0.005
74042435|NCT03418051|147636725|SUPERIORITY|||||||0.853||||||A priori threshold set at 0.05.|ANOVA|||||||0.853
74042436|NCT03418051|147636726|SUPERIORITY|||||||0.142||||||A priori threshold set to 0.05|ANOVA|||||||0.142
74042437|NCT03418051|147636726|SUPERIORITY|||||||0.167||||||A priori threshold set at 0.05.|ANOVA|||||||0.167
74042438|NCT03418051|147636727|SUPERIORITY|||||||0.849||||||A priori alpha set at 0.05.|ANOVA|||||||0.849
74042439|NCT03418051|147636727|SUPERIORITY|||||||0.993||||||A priori threshold set at 0.05.|ANOVA|||||||0.993
74042440|NCT03418051|147636728|SUPERIORITY|||||||0.535||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.535
74042441|NCT03418051|147636728|SUPERIORITY|||||||0.569||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.569
74042442|NCT03418051|147636729|SUPERIORITY|||||||0.405||||||A priori threshold was 0.05.|ANOVA|||||||0.405
74042443|NCT03418051|147636729|SUPERIORITY|||||||0.229||||||A priori threshold set to 0.05.|ANOVA|||||||0.229
74042444|NCT03418051|147636730|SUPERIORITY|||||||0.609||||||A priori threshold set at 0.05.|ANOVA|||||||0.609
74042445|NCT03418051|147636730|SUPERIORITY|||||||0.027||||||A priori threshold was set at 0.05.|ANOVA|||||||0.027
74042446|NCT03418051|147636731|SUPERIORITY|||||||0.613||||||A priori alpha set at 0.05.|Independent sample Mann-Whitney U|||||||0.613
74042447|NCT03418051|147636732|SUPERIORITY|||||||0.925||||||A priori threshold set at 0.05.|Independent sample Mann-Whitney U|||||||0.925
74042448|NCT03418051|147636733|SUPERIORITY|||||||0.641||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.641
74042449|NCT03418051|147636733|SUPERIORITY|||||||0.897||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.897
73879707|NCT03192176|147297615|SUPERIORITY||LSMean difference|28.9|STANDARD_ERROR_OF_MEAN|6.91|<|0.0001|TWO_SIDED|95.0|15.27|42.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||42.46|15.27|<0.0001
74012130|NCT02819635|147575068|SUPERIORITY||LS Mean Difference|-2.938|||<|0.001|TWO_SIDED|95.0|-4.0284|-1.8478||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||-1.8478|-4.0284|<0.001
74012131|NCT02819635|147575068|SUPERIORITY||LS Mean Difference|-3.736|||<|0.001|TWO_SIDED|95.0|-4.8247|-2.647||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||-2.6470|-4.8247|<0.001
74012132|NCT02819635|147575068|SUPERIORITY||LS Mean Difference|-4.061|||<|0.001|TWO_SIDED|95.0|-5.1252|-2.9974||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||-2.9974|-5.1252|<0.001
74012133|NCT02819635|147575069|SUPERIORITY||Adjusted risk difference (%)|6.6||||0.075|TWO_SIDED|95.0|-0.7|13.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||13.9|-0.7|0.075
74012134|NCT02819635|147575069|SUPERIORITY||Adjusted risk difference (%)|3.8||||0.199|TWO_SIDED|95.0|-2.0|9.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||9.6|-2.0|0.199
74012135|NCT02819635|147575069|SUPERIORITY||Adjusted risk difference (%)|11.1||||0.015|TWO_SIDED|95.0|2.2|20.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||20.0|2.2|0.015
74042450|NCT03418051|147636734|SUPERIORITY|||||||0.561||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.561
74042451|NCT03418051|147636734|SUPERIORITY|||||||0.925||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.925
74042452|NCT03418051|147636735|SUPERIORITY|||||||0.233||||||A priori threshold set at 0.05|ANOVA|||||||0.233
73879708|NCT03192176|147297615|SUPERIORITY||LSMean difference|36.8|STANDARD_ERROR_OF_MEAN|7.01|<|0.0001|TWO_SIDED|95.0|22.99|50.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||50.57|22.99|<0.0001
73879709|NCT03192176|147297615|SUPERIORITY||LSMean difference|15.6|STANDARD_ERROR_OF_MEAN|6.99||0.0265|TWO_SIDED|95.0|1.83|29.34||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||29.34|1.83|0.0265
73879710|NCT03192176|147297615|SUPERIORITY||LSMean difference|21.2|STANDARD_ERROR_OF_MEAN|6.89||0.0023|TWO_SIDED|95.0|7.6|34.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||34.71|7.60|0.0023
74012136|NCT02819635|147575069|SUPERIORITY||Adjusted risk difference (%)|17.8||||0.004|TWO_SIDED|95.0|5.8|29.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||29.9|5.8|0.004
74042453|NCT03418051|147636735|SUPERIORITY|||||||0.634||||||A priori threshold set at 0.05|ANOVA|||||||0.634
73879711|NCT03192176|147297615|SUPERIORITY||LSMean difference|27.1|STANDARD_ERROR_OF_MEAN|6.85|<|0.0001|TWO_SIDED|95.0|13.64|40.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||40.59|13.64|<0.0001
74042454|NCT03418051|147636736|SUPERIORITY|||||||0.233||||||A priori threshold set at 0.05.|ANOVA|||||||0.233
74042455|NCT03418051|147636736|SUPERIORITY|||||||0.634||||||A priori threshold set at 0.05.|ANOVA|||||||0.634
74042456|NCT03418051|147636737|SUPERIORITY|||||||0.03||||||A priori threshold set at 0.05.|ANOVA|||||||0.030
74042457|NCT03418051|147636737|SUPERIORITY|||||||0.618||||||A priori threshold set at 0.05.|ANOVA|||||||0.618
74042458|NCT03418051|147636738|SUPERIORITY|||||||0.456||||||A priori threshold set at 0.05.|ANOVA|||||||0.456
74042459|NCT03418051|147636738|SUPERIORITY|||||||0.568||||||A priori threshold set to 0.05.|ANOVA|||||||0.568
74012137|NCT02819635|147575070|SUPERIORITY||Adjusted risk difference (%)|25.6||||0.003|TWO_SIDED|95.0|8.9|42.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||42.3|8.9|0.003
73879712|NCT03192176|147297615|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|6.8||0.158|TWO_SIDED|95.0|-3.75|22.99||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||22.99|-3.75|0.1580
74012138|NCT02819635|147575070|SUPERIORITY||Adjusted risk difference (%)|43.6|||<|0.001|TWO_SIDED|95.0|25.4|61.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||61.8|25.4|<0.001
74012139|NCT02819635|147575070|SUPERIORITY||Adjusted risk difference (%)|39.4|||<|0.001|TWO_SIDED|95.0|21.3|57.5||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||57.5|21.3|<0.001
74012140|NCT02819635|147575070|SUPERIORITY||Adjusted risk difference (%)|43.1|||<|0.001|TWO_SIDED|95.0|24.4|61.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||61.9|24.4|<0.001
74012141|NCT02819635|147575071|SUPERIORITY||Adjusted risk difference (%)|29.3|||<|0.001|TWO_SIDED|95.0|22.6|35.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||35.9|22.6|<0.001
74012142|NCT02819635|147575072|SUPERIORITY||Adjusted risk difference (%)|12.7|||<|0.001|TWO_SIDED|95.0|8.4|17.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||17.0|8.4|<0.001
74012143|NCT02819635|147575073|SUPERIORITY||Adjusted risk difference (%)|46.3|||<|0.001|TWO_SIDED|95.0|38.4|54.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||54.2|38.4|<0.001
74012144|NCT02819635|147575074|SUPERIORITY||Adjusted risk difference (%)|33.3|||<|0.001|TWO_SIDED|95.0|24.8|41.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)||Substudy 2: Upadacitinib 45 mg vs Placebo|Difference = Upadacitinib 45 mg - Placebo|41.8|24.8|<0.001
74042460|NCT03418051|147636739|SUPERIORITY|||||||0.919||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.919
74042461|NCT03418051|147636739|SUPERIORITY|||||||0.558||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.558
74042462|NCT03418051|147636740|SUPERIORITY|||||||0.796||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.796
74042463|NCT03418051|147636740|SUPERIORITY|||||||0.558||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.558
74042464|NCT03418051|147636741|SUPERIORITY|||||||0.701||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.701
74042465|NCT03418051|147636741|SUPERIORITY|||||||0.68||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.68
73879713|NCT03192176|147297615|SUPERIORITY||LSMean difference|18.1|STANDARD_ERROR_OF_MEAN|6.8||0.0082|TWO_SIDED|95.0|4.72|31.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||31.50|4.72|0.0082
74042466|NCT03418051|147636742|SUPERIORITY|||||||0.883||||||A priori threshold set at 0.05.|ANOVA|||||||0.883
74042467|NCT03418051|147636742|SUPERIORITY|||||||0.401||||||A priori threshold set at 0.05.|ANOVA|||||||0.401
74042468|NCT03418051|147636743|SUPERIORITY|||||||0.393||||||A priori threshold set at 0.05.|ANOVA|||||||0.393
74042469|NCT03418051|147636743|SUPERIORITY|||||||0.779||||||A priori threshold set at 0.05.|ANOVA|||||||0.779
74042470|NCT03418051|147636744|SUPERIORITY|||||||0.246||||||A priori threshold set at 0.05.|ANOVA|||||||0.246
74042471|NCT03418051|147636744|SUPERIORITY|||||||0.191||||||A priori threshold set at 0.05.|ANOVA|||||||0.191
74042472|NCT03418051|147636745|SUPERIORITY|||||||0.703||||||A priori threshold set at 0.05.|ANOVA|||||||0.703
74042473|NCT03418051|147636745|SUPERIORITY|||||||0.282||||||A priori threshold set at 0.05.|ANOVA|||||||0.282
73879714|NCT03192176|147297615|SUPERIORITY||LSMean difference|25.2|STANDARD_ERROR_OF_MEAN|6.85||0.0003|TWO_SIDED|95.0|11.77|38.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||38.71|11.77|0.0003
73879715|NCT03192176|147297615|SUPERIORITY||LSMean difference|30.6|STANDARD_ERROR_OF_MEAN|6.96|<|0.0001|TWO_SIDED|95.0|16.93|44.31||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||44.31|16.93|<0.0001
73879716|NCT03192176|147297615|SUPERIORITY||LSMean difference|11.2|STANDARD_ERROR_OF_MEAN|6.93||0.1074|TWO_SIDED|95.0|-2.45|24.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||24.84|-2.45|0.1074
73879717|NCT03192176|147297615|SUPERIORITY||LSMean difference|18.3|STANDARD_ERROR_OF_MEAN|6.83||0.0077|TWO_SIDED|95.0|4.87|31.76||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||31.76|4.87|0.0077
73879718|NCT03192176|147297615|SUPERIORITY||LSMean difference|23.6|STANDARD_ERROR_OF_MEAN|6.79||0.0006|TWO_SIDED|95.0|10.29|37.01||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||37.01|10.29|0.0006
73879719|NCT03192176|147297615|SUPERIORITY||LSMean difference|11.8|STANDARD_ERROR_OF_MEAN|6.47||0.0689|TWO_SIDED|95.0|-0.92|24.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||24.53|-0.92|0.0689
73879720|NCT03192176|147297615|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.46||0.025|TWO_SIDED|95.0|1.84|27.27||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||27.27|1.84|0.0250
73879721|NCT03192176|147297615|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.51||0.0002|TWO_SIDED|95.0|11.54|37.17||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||37.17|11.54|0.0002
73879722|NCT03192176|147297615|SUPERIORITY||LSMean difference|29.6|STANDARD_ERROR_OF_MEAN|6.6|<|0.0001|TWO_SIDED|95.0|16.6|42.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||42.57|16.60|<0.0001
74042474|NCT03418051|147636746|SUPERIORITY|||||||0.925||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.925
74042475|NCT03418051|147636746|SUPERIORITY|||||||0.551||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.551
74042476|NCT03418051|147636747|SUPERIORITY|||||||0.506||||||A priori threshold set at 0.05.|ANOVA|||||||0.506
74042477|NCT03418051|147636747|SUPERIORITY|||||||0.753||||||A priori threshold at 0.05.|ANOVA|||||||0.753
74042478|NCT03418051|147636748|SUPERIORITY|||||||0.777||||||A priori threshold set at 0.05.|ANOVA|||||||0.777
74042479|NCT03418051|147636748|SUPERIORITY|||||||0.475||||||A priori threshold set at 0.05.|ANOVA|||||||0.475
74042480|NCT03418051|147636749|SUPERIORITY|||||||0.738||||||A priori threshold set at 0.05.|ANOVA|||||||0.738
74042481|NCT03418051|147636749|SUPERIORITY|||||||0.042||||||A priori threshold set at 0.05.|ANOVA|||||||0.042
74042482|NCT03418051|147636750|SUPERIORITY|||||||0.738||||||A priori threshold set at 0.05.|ANOVA|||||||0.738
74042483|NCT03418051|147636750|SUPERIORITY|||||||0.83||||||A priori threshold set at 0.05.|ANOVA|||||||0.830
74042484|NCT03418051|147636751|SUPERIORITY|||||||0.7||||||A priori threshold set at 0.05.|ANOVA|||||||0.700
74042485|NCT03418051|147636751|SUPERIORITY|||||||0.492||||||A priori threshold set at 0.05.|ANOVA|||||||0.492
74042486|NCT03418051|147636752|SUPERIORITY|||||||0.82||||||A priori threshold set at 0.05.|ANOVA|||||||0.820
74042487|NCT03418051|147636752|SUPERIORITY|||||||0.526||||||A priori threshold set at 0.05.|ANOVA|||||||0.526
74042488|NCT02193828|147636765|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
74042489|NCT02193828|147636765|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
74042490|NCT02193828|147636765|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
74042491|NCT02193828|147636765|SUPERIORITY_OR_OTHER|||||||0.0713|TWO_SIDED||||||ANOVA|||For surface area||||.0713
74042492|NCT02193828|147636765|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANOVA|||For volume||||.0002
74042493|NCT02193828|147636765|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||For volume||||.0001
74042494|NCT02193828|147636765|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||For volume||||.0001
74042495|NCT02193828|147636765|SUPERIORITY_OR_OTHER|||||||0.0446|TWO_SIDED||||||ANOVA|||For volume||||.0446
74042496|NCT02193828|147636766|SUPERIORITY_OR_OTHER|||||||0.2431|TWO_SIDED||||||ANOVA|||For surface area||||.2431
74042497|NCT02193828|147636766|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED||||||ANOVA|||For surface area||||.0625
74042498|NCT02193828|147636766|SUPERIORITY_OR_OTHER|||||||0.3409|TWO_SIDED||||||ANOVA|||For surface area||||.3409
74042499|NCT02193828|147636766|SUPERIORITY_OR_OTHER|||||||0.704|TWO_SIDED||||||ANOVA|||For surface area||||.7040
74042500|NCT02193828|147636766|SUPERIORITY_OR_OTHER|||||||0.3556|TWO_SIDED||||||ANOVA|||For volume||||0.3556
74042501|NCT02193828|147636766|SUPERIORITY_OR_OTHER|||||||0.1275|TWO_SIDED||||||ANOVA|||For volume||||.1275
74012145|NCT02819635|147575075|SUPERIORITY||Adjusted risk difference (%)|23.7|||<|0.001|TWO_SIDED|95.0|17.5|30.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||30.0|17.5|<0.001
74012146|NCT02819635|147575076|SUPERIORITY||Adjusted risk difference (%)|27.4|||<|0.001|TWO_SIDED|95.0|19.2|35.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||35.6|19.2|<0.001
74012147|NCT02819635|147575077|SUPERIORITY||Adjusted risk difference (%)|23.6|||<|0.001|TWO_SIDED|95.0|15.1|32.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||32.1|15.1|<0.001
74012148|NCT02819635|147575078|SUPERIORITY||Adjusted risk difference (%)|32.2|||<|0.001|TWO_SIDED|95.0|23.8|40.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||40.7|23.8|<0.001
74012149|NCT02819635|147575079|SUPERIORITY||Least Squares (LS) Mean Difference|33.7|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|27.02|40.36||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||40.36|27.02|<0.001
74012150|NCT02819635|147575080|SUPERIORITY||Adjusted risk difference (%)|9.7|||<|0.001|TWO_SIDED|95.0|5.7|13.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||13.7|5.7|<0.001
74012151|NCT02819635|147575081|SUPERIORITY||Least Squares (LS) Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|4.79|8.59||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||8.59|4.79|<0.001
74042502|NCT02193828|147636766|SUPERIORITY_OR_OTHER|||||||0.7883|TWO_SIDED||||||ANOVA|||For volume||||.7883
74042503|NCT02193828|147636766|SUPERIORITY_OR_OTHER|||||||0.9123|TWO_SIDED||||||ANOVA|||For volume||||.9123
74042504|NCT02193828|147636767|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Kruskal-Wallis|||||||.0002
74042505|NCT02193828|147636767|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.0001
74042506|NCT02193828|147636767|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0002
74042507|NCT02193828|147636767|SUPERIORITY_OR_OTHER|||||||0.0139|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0139
74042508|NCT02193828|147636768|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANOVA|||||||.0004
74042509|NCT02193828|147636768|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||ANOVA|||||||.0075
74042510|NCT02193828|147636768|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<.0001
74042511|NCT02193828|147636768|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||ANOVA|||||||.0031
74042512|NCT02193828|147636769|SUPERIORITY_OR_OTHER|||||||0.3135|TWO_SIDED||||||ANOVA|||||||.3135
74042513|NCT02193828|147636769|SUPERIORITY_OR_OTHER|||||||0.7249|TWO_SIDED||||||ANOVA|||||||.7249
74042514|NCT02193828|147636769|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED||||||ANOVA|||||||.1573
74042515|NCT02193828|147636769|SUPERIORITY_OR_OTHER|||||||0.1234|TWO_SIDED||||||ANOVA|||||||.1234
74042516|NCT02193828|147636770|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kruskal-Wallis|||||||.0006
74042517|NCT02193828|147636770|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0014
74042518|NCT02193828|147636770|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0012
74042519|NCT02193828|147636770|SUPERIORITY_OR_OTHER|||||||0.1298|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.1298
74042520|NCT02193828|147636771|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||Kruskal-Wallis|||||||.0048
74042521|NCT02193828|147636771|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0034
74042522|NCT02193828|147636771|SUPERIORITY_OR_OTHER|||||||0.0079|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0079
74042523|NCT02193828|147636771|SUPERIORITY_OR_OTHER|||||||0.3216|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.3216
74042524|NCT02193828|147636772|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED||||||Fisher Exact|||||||.0065
74042525|NCT02193828|147636772|SUPERIORITY_OR_OTHER|||||||0.0349|TWO_SIDED||||||Fisher Exact|||||||.0349
74042526|NCT02193828|147636772|SUPERIORITY_OR_OTHER|||||||0.0033|TWO_SIDED||||||Fisher Exact|||||||.0033
74042527|NCT02193828|147636772|SUPERIORITY_OR_OTHER|||||||0.3423|TWO_SIDED||||||Fisher Exact|||||||.3423
74012152|NCT02819635|147575082|SUPERIORITY||Adjusted risk difference (%)|34.4|||<|0.001|TWO_SIDED|95.0|25.1|43.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||43.7|25.1|<0.001
74093978|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.02|1.35|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6B: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.35|1.02|
73888001|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.4454|TWO_SIDED|95.0|-5.6|12.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.8|-5.6|0.4454
74012153|NCT02819635|147575082|SUPERIORITY||Adjusted risk difference (%)|46.3|||<|0.001|TWO_SIDED|95.0|36.7|55.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||55.8|36.7|<0.001
74012154|NCT02819635|147575083|SUPERIORITY||Adjusted risk difference (%)|37.4|||<|0.001|TWO_SIDED|95.0|20.3|54.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||54.6|20.3|<0.001
74012155|NCT02819635|147575083|SUPERIORITY||Adjusted risk difference (%)|47.0|||<|0.001|TWO_SIDED|95.0|30.7|63.3||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||63.3|30.7|<0.001
74012156|NCT02819635|147575084|SUPERIORITY||Adjusted risk difference (%)|35.4|||<|0.001|TWO_SIDED|95.0|18.2|52.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||52.7|18.2|<0.001
74012157|NCT02819635|147575084|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|28.7|61.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||61.6|28.7|<0.001
74012158|NCT02819635|147575085|SUPERIORITY||Adjusted risk difference (%)|42.0|||<|0.001|TWO_SIDED|95.0|27.8|56.2||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||56.2|27.8|<0.001
74012159|NCT02819635|147575085|SUPERIORITY||Adjusted risk difference (%)|48.6|||<|0.001|TWO_SIDED|95.0|35.5|61.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||61.7|35.5|<0.001
74012160|NCT02819635|147575086|SUPERIORITY||Adjusted risk difference (%)|18.7|||<|0.001|TWO_SIDED|95.0|11.0|26.4||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||26.4|11.0|<0.001
74042528|NCT01686958|147636792|OTHER|This is a primarily descriptive study, no statistical analysis is planned; however, analyses were performed at the alpha=0.05 level of significance and exact analyses will be used wherever possible.|||||||ONE_SIDED|95.0||||Confidence intervals \[CI\] will be constructed for outcomes of interest at the alpha=0.05 level of significance, i.e. 95% CI.||||A total of 30 subjects will be accrued to this study and treated with the PAD-105. The sample size is based primarily on feasibility and logistical concerns, however, is sufficiently large to allow the safety objectives to be met. Specifically, with 30 total patients, if no treatment-related grade 4 or 5 adverse events are observed, then a one-sided, 95% confidence interval would have an upper bound of 0.095.|For continuous outcomes, standard summary statistics will include n, mean, standard deviation, median, minimum and maximum. For categorical data, tables will show n and % of patients.|||
74042529|NCT03162458|147636808|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
74042530|NCT03162458|147636809|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
74042531|NCT03162458|147636810|SUPERIORITY|||||||0.055|||||||Log Rank|||||||0.055
74042532|NCT03162458|147636811|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||||||0.051
74012161|NCT02819635|147575086|SUPERIORITY||Adjusted risk difference (%)|19.4|||<|0.001|TWO_SIDED|95.0|11.7|27.2||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||27.2|11.7|<0.001
74012162|NCT02819635|147575087|SUPERIORITY||Adjusted risk difference (%)|44.6|||<|0.001|TWO_SIDED|95.0|34.5|54.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||54.7|34.5|<0.001
74012163|NCT02819635|147575087|SUPERIORITY||Adjusted risk difference (%)|56.6|||<|0.001|TWO_SIDED|95.0|47.2|66.0||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||66.0|47.2|<0.001
74012164|NCT02819635|147575088|SUPERIORITY||Adjusted risk difference (%)|23.8|||<|0.001|TWO_SIDED|95.0|14.8|32.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||32.8|14.8|<0.001
74012165|NCT02819635|147575088|SUPERIORITY||Adjusted risk difference (%)|37.3|||<|0.001|TWO_SIDED|95.0|27.8|46.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||46.8|27.8|<0.001
74012166|NCT02819635|147575089|SUPERIORITY||LS Mean Difference|31.3|STANDARD_ERROR_OF_MEAN|4.77|<|0.001|TWO_SIDED|95.0|21.98|40.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||40.70|21.98|<0.001
74012167|NCT02819635|147575089|SUPERIORITY||LS Mean Difference|41.0|STANDARD_ERROR_OF_MEAN|4.88|<|0.001|TWO_SIDED|95.0|31.39|50.55||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||50.55|31.39|<0.001
74012168|NCT02819635|147575090|SUPERIORITY||Adjusted risk difference (%)|13.0|||<|0.001|TWO_SIDED|95.0|6.0|20.0||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||20.0|6.0|<0.001
74012169|NCT02819635|147575090|SUPERIORITY||Adjusted risk difference (%)|13.6|||<|0.001|TWO_SIDED|95.0|6.6|20.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||20.6|6.6|<0.001
74042533|NCT03162458|147636812|SUPERIORITY|||||||0.19|||||||ANOVA|||Mean body temperatures, measured in the morning on Days 2-5 (based on patient diary data)||||0.19
74042534|NCT03162458|147636812|SUPERIORITY|||||||0.44|||||||ANOVA|||Mean body temperatures, measured in the evening on Days 2-5 (based on patient diary data)||||0.44
74093979|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.65|1.01|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 7F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.01|0.65|
74093980|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.69|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 9V: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.69|
73888002|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9||||0.0934|TWO_SIDED|95.0|-1.3|17.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.1|-1.3|0.0934
74042535|NCT03162458|147636813|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
74042536|NCT03162458|147636814|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
74042537|NCT03162458|147636815|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74042538|NCT03162458|147636816|SUPERIORITY|||||||0.63|||||||ANOVA|||||||0.63
74012170|NCT02819635|147575091|SUPERIORITY||Adjusted risk difference (%)|38.7|||<|0.001|TWO_SIDED|95.0|28.9|48.5||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||48.5|28.9|<0.001
74012171|NCT02819635|147575091|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|35.5|54.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||54.8|35.5|<0.001
74042539|NCT03162458|147636817|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74042540|NCT00861380|147636893|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|82.8|100.0||P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 =(vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||100|82.8|<0.0001
74042541|NCT00861380|147636894|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1vsControl). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect.|VE (1-RR)|91.8|||=|0.0009|TWO_SIDED|95.0|58.3|99.6||p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||99.6|58.3|= 0.0009
74042542|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|14.657|||||TWO_SIDED|95.0|13.229|16.197|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||16.197|13.229|
74042543|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|13.582|||||TWO_SIDED|95.0|11.691|15.693|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||15.693|11.691|
74093981|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.05|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 14: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.05|0.79|
74042544|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|8.452|||||TWO_SIDED|95.0|7.376|9.639|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||9.639|7.376|
73888003|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0||||0.1358|TWO_SIDED|95.0|-2.2|16.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.2|-2.2|0.1358
73879723|NCT03192176|147297615|SUPERIORITY||LSMean difference|8.4|STANDARD_ERROR_OF_MEAN|6.59||0.2041|TWO_SIDED|95.0|-4.58|21.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||21.36|-4.58|0.2041
73879724|NCT03192176|147297615|SUPERIORITY||LSMean difference|18.4|STANDARD_ERROR_OF_MEAN|6.5||0.0049|TWO_SIDED|95.0|5.62|31.2||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||31.20|5.62|0.0049
73879725|NCT03192176|147297615|SUPERIORITY||LSMean difference|20.7|STANDARD_ERROR_OF_MEAN|6.45||0.0015|TWO_SIDED|95.0|8.0|33.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||33.37|8.00|0.0015
74012172|NCT02819635|147575092|SUPERIORITY||Adjusted risk difference (%)|24.3|||<|0.001|TWO_SIDED|95.0|14.2|34.5||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||34.5|14.2|<0.001
74042545|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|7.603|||||TWO_SIDED|95.0|6.206|9.221|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.221|6.206|
74042546|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|1.637|||||TWO_SIDED|95.0|1.185|2.205|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||2.205|1.185|
74042547|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|1.845|||||TWO_SIDED|95.0|1.194|2.724|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.724|1.194|
74093982|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.97|1.23|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 18C: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.23|0.97|
74093983|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.89|1.07|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.07|0.89|
73879726|NCT03192176|147297615|SUPERIORITY||LSMean difference|15.8|STANDARD_ERROR_OF_MEAN|6.66||0.0184|TWO_SIDED|95.0|2.68|28.89||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||28.89|2.68|0.0184
73879727|NCT03192176|147297615|SUPERIORITY||LSMean difference|12.8|STANDARD_ERROR_OF_MEAN|6.66||0.0551|TWO_SIDED|95.0|-0.28|25.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||25.93|-0.28|0.0551
73879728|NCT03192176|147297615|SUPERIORITY||LSMean difference|25.8|STANDARD_ERROR_OF_MEAN|6.73||0.0002|TWO_SIDED|95.0|12.51|39.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||39.00|12.51|0.0002
73879729|NCT03192176|147297615|SUPERIORITY||LSMean difference|31.6|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|18.17|44.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||44.93|18.17|<0.0001
74042548|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as . 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 2626735.|PYAR|3.997|||||TWO_SIDED|95.0|3.269|4.839|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||4.839|3.269|
74042549|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 1354702.|PYAR|3.322|||||TWO_SIDED|95.0|2.423|4.445|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||4.445|2.423|
74042550|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|14.487|||||TWO_SIDED|95.0|13.071|16.015|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||16.015|13.071|
74042551|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|13.74|||||TWO_SIDED|95.0|11.841|15.857|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||15.857|11.841|
74042552|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|7.813|||||TWO_SIDED|95.0|6.782|8.955|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||8.955|6.782|
74042553|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|7.789|||||TWO_SIDED|95.0|6.377|9.42|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.420|6.377|
74093984|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.83|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.83|
74093985|NCT00546572|147738987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.6|2.14|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 23F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||2.14|1.60|
74093986|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|1.1|1.76|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 1: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.76|1.10|
74042554|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|2.313|||||TWO_SIDED|95.0|1.77|2.972|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||2.972|1.770|
74042555|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|1.984|||||TWO_SIDED|95.0|1.307|2.886|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.886|1.307|
74042556|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =2636783.|PYAR|4.172|||||TWO_SIDED|95.0|3.429|5.028|||Negative Binomial model without strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||5.028|3.429|
74042557|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =1360966.|PYAR|3.968|||||TWO_SIDED|95.0|2.981|5.177|||Negative Binomial model without strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||5.177|2.981|
74093987|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.1|||||TWO_SIDED|95.0|0.91|1.34|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 3: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.34|0.91|
74093988|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.3|||||TWO_SIDED|95.0|1.66|3.25|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 4: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||3.25|1.66|
73879730|NCT03192176|147297615|SUPERIORITY||LSMean difference|14.3|STANDARD_ERROR_OF_MEAN|6.79||0.0367|TWO_SIDED|95.0|0.89|27.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Wek 10||27.62|0.89|0.0367
73879731|NCT03192176|147297615|SUPERIORITY||LSMean difference|21.2|STANDARD_ERROR_OF_MEAN|6.7||0.0017|TWO_SIDED|95.0|7.99|34.34||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||34.34|7.99|0.0017
73888004|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|59.8||||0.0004|TWO_SIDED|95.0|27.0|92.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||92.7|27.0|0.0004
74042558|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|14.017|||||TWO_SIDED|95.0|12.628|15.516|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||15.516|12.628|
74042559|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|15.066|||||TWO_SIDED|95.0|13.079|17.269|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||17.269|13.079|
74042560|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|5.916|||||TWO_SIDED|95.0|5.026|6.917|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||6.917|5.026|
74042561|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|8.557|||||TWO_SIDED|95.0|7.077|10.255|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.255|7.077|
74012173|NCT02819635|147575092|SUPERIORITY||Adjusted risk difference (%)|33.7|||<|0.001|TWO_SIDED|95.0|23.6|43.9||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||43.9|23.6|<0.001
74012174|NCT02819635|147575093|SUPERIORITY||LS Mean Difference|5.1|||<|0.001|TWO_SIDED|95.0|2.67|7.52||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||7.52|2.67|<0.001
74012175|NCT02819635|147575093|SUPERIORITY||LS Mean Difference|5.9|||<|0.001|TWO_SIDED|95.0|3.44|8.27||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||8.27|3.44|<0.001
74012176|NCT01035099|147575097|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.31
74012177|NCT01035099|147575098|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.19
74012178|NCT01035099|147575101|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.12
74012179|NCT01035099|147575102|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.77
74012180|NCT01035099|147575103|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.63
74012181|NCT01035099|147575105|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.14
74012182|NCT01035099|147575106|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||<0.0001
74012183|NCT01035099|147575107|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.58
74012184|NCT01035099|147575109|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.42
74012185|NCT01438489|147575126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.014|TWO_SIDED|90.0|1.33|4.26|||Regression, Logistic|||All-comers||4.26|1.33|0.014
74012186|NCT01438489|147575126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.063|TWO_SIDED|90.0|1.08|3.49|||Regression, Logistic|||All-comers||3.49|1.08|0.063
74012187|NCT01438489|147575127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55||||0.004|TWO_SIDED|90.0|1.72|7.32|||Regression, Logistic|||High||7.32|1.72|0.004
74093989|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.21|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 5: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.06|1.21|
74012188|NCT01438489|147575127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.65||||0.029|TWO_SIDED|90.0|1.27|5.53|||Regression, Logistic|||High||5.53|1.27|0.029
74012189|NCT03129321|147575155|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|4.24|||||TWO_SIDED|90.0|-5.05|13.54||||||||13.54|-5.05|
74012190|NCT03129321|147575156|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74012191|NCT03129321|147575156|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
74012192|NCT03129321|147575157|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|2.85|||||TWO_SIDED|90.0|-6.29|11.98||||||||11.98|-6.29|
74012193|NCT03129321|147575158|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|-0.02|||||TWO_SIDED|90.0|-8.29|8.26||||||||8.26|-8.29|
74012194|NCT03129321|147575159|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||||||0.0020
74012195|NCT03129321|147575159|SUPERIORITY|||||||0.0076|||||||Cochran-Mantel-Haenszel|||||||0.0076
74012196|NCT03129321|147575160|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74012197|NCT03129321|147575160|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74012198|NCT01148537|147575164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|||<|0.001|TWO_SIDED|90.0|3.4|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.||||8.4|3.4|< .001
74012199|NCT01148537|147575165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.77|TWO_SIDED|90.0|-1.8|2.6|||ANCOVA||For the comparison of BTDS to placebo, the subjects randomized to moxifloxacin were excluded.|||2.6|-1.8|.770
74012200|NCT01148537|147575166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|||<|0.001|TWO_SIDED|90.0|3.3|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.||Day 13 analysis||8.4|3.3|< .001
74012201|NCT01148537|147575167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.64|||<|0.001|TWO_SIDED|90.0|5.4|9.9|||ANCOVA|ANCOVA model with average baseline as a covariate, and with gender and treatment as main effects||||9.9|5.4|< .001
74012202|NCT01148537|147575168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.936|TWO_SIDED|90.0|-2.9|2.6|||ANCOVA|||Day 6 analysis||2.6|-2.9|.936
74012203|NCT01148537|147575168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.16|||<|0.001|TWO_SIDED|90.0|4.2|10.1|||ANCOVA|||Day 13 analysis||10.1|4.2|< .001
74012204|NCT01148537|147575169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.23|||<|0.001|TWO_SIDED|90.0|5.5|10.9|||ANCOVA|||Day 6 analysis||10.9|5.5|< .001
74012205|NCT01148537|147575169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|90.0|4.3|10.5|||ANCOVA|||Day 13 analysis||10.5|4.3|< .001
74012206|NCT01148537|147575170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.427|TWO_SIDED|90.0|-1.4|4.0|||ANCOVA|||Day 6 analysis||4.0|-1.4|.427
74012207|NCT01148537|147575170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.01||||0.001|TWO_SIDED|90.0|3.2|8.8|||ANCOVA|||Day 13 analysis||8.8|3.2|.001
74012208|NCT01148537|147575171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|||<|0.001|TWO_SIDED|90.0|4.2|9.6|||ANCOVA|||Day 6 analysis||9.6|4.2|< .001
74012209|NCT01148537|147575171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68||||0.006|TWO_SIDED|90.0|1.9|7.4|||ANCOVA|||Day 13 analysis||7.4|1.9|.006
74012210|NCT01324232|147575172|SUPERIORITY||Pearson correlation|0.0019|||=|0.9827|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between the change from Baseline PRS scores and the DM plasma concentration was equal to zero and was tested using a 2-sided test at the 5% level of significance within active treatment groups. The regression line was fitted using change from baseline in average PRS during Day 57-84 as the dependent variable and the average of log-transformed DM Plasma Concentration at Day 22 and Day 50 as the independent variable.||||= 0.9827
74012211|NCT01324232|147575174|SUPERIORITY||||||=|0.8869|||||||ANCOVA|||Test of dose trend (overall P value)||||=0.8869
74093990|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|3.8|||||TWO_SIDED|95.0|2.78|5.07|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 6B: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||5.07|2.78|
73879732|NCT03192176|147297615|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.65||0.0003|TWO_SIDED|95.0|11.29|37.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||37.44|11.29|0.0003
73879733|NCT03192176|147297615|SUPERIORITY||LSMean difference|14.5|STANDARD_ERROR_OF_MEAN|6.45||0.0255|TWO_SIDED|95.0|1.78|27.15||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||27.15|1.78|0.0255
73879734|NCT03192176|147297615|SUPERIORITY||LSMean difference|15.3|STANDARD_ERROR_OF_MEAN|6.45||0.0186|TWO_SIDED|95.0|2.57|27.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||27.94|2.57|0.0186
73879735|NCT03192176|147297615|SUPERIORITY||LSMean difference|26.5|STANDARD_ERROR_OF_MEAN|6.52|<|0.0001|TWO_SIDED|95.0|13.71|39.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||39.36|13.71|<0.0001
73879736|NCT03192176|147297615|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|16.94|42.81||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||42.81|16.94|<0.0001
73879737|NCT03192176|147297615|SUPERIORITY||LSMean difference|13.9|STANDARD_ERROR_OF_MEAN|6.57||0.0347|TWO_SIDED|95.0|1.01|26.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||26.85|1.01|0.0347
73879738|NCT03192176|147297615|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.48||0.0008|TWO_SIDED|95.0|9.16|34.65||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||34.65|9.16|0.0008
73879739|NCT03192176|147297615|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|6.43||0.0003|TWO_SIDED|95.0|10.75|36.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||36.04|10.75|0.0003
73879740|NCT03192176|147297615|SUPERIORITY||LSMean difference|14.8|STANDARD_ERROR_OF_MEAN|6.43||0.0221|TWO_SIDED|95.0|2.13|27.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||27.43|2.13|0.0221
73879741|NCT03192176|147297615|SUPERIORITY||LSMean difference|17.0|STANDARD_ERROR_OF_MEAN|6.43||0.0087|TWO_SIDED|95.0|4.32|29.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||29.62|4.32|0.0087
74012212|NCT01324232|147575174|SUPERIORITY||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.46|=|0.9381|TWO_SIDED|95.0|-0.94|0.87|||ANCOVA|||Pairwise treatment group vs placebo||0.87|-0.94|=0.9381
73879742|NCT03192176|147297615|SUPERIORITY||LSMean difference|26.4|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|13.65|39.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||39.23|13.65|<0.0001
73879743|NCT03192176|147297615|SUPERIORITY||LSMean difference|31.0|STANDARD_ERROR_OF_MEAN|6.56|<|0.0001|TWO_SIDED|95.0|18.13|43.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||43.94|18.13|<0.0001
73888005|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7||||0.2365|TWO_SIDED|95.0|-13.1|52.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||52.6|-13.1|0.2365
74012213|NCT01324232|147575174|SUPERIORITY||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.46|=|0.4128|TWO_SIDED|95.0|-1.28|0.53|||ANCOVA|||Pairwise treatment group vs placebo||0.53|-1.28|=0.4128
74042562|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =2654010.|PYAR|2.977|||||TWO_SIDED|95.0|2.357|3.71|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||3.710|2.357|
74093991|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||TWO_SIDED|95.0|0.8|1.67|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 7F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.67|0.80|
74042563|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =1367343.|PYAR|2.048|||||TWO_SIDED|95.0|1.361|2.96|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.960|1.361|
74042564|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|5.011|||||TWO_SIDED|95.0|4.196|5.939|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||5.939|4.196|
74042565|NCT00861380|147636898|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|4.315|||||TWO_SIDED|95.0|3.285|5.566|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||5.566|3.285|
74042566|NCT00861380|147636906|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2626735.|PYAR|9.218|||||TWO_SIDED|95.0|9.103|9.335|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||9.335|9.103|
74042567|NCT00861380|147636906|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1354702.|PYAR|9.212|||||TWO_SIDED|95.0|9.052|9.375|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.375|9.052|
74042568|NCT00861380|147636906|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|10.5|||||TWO_SIDED|95.0|10.378|10.624|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||10.624|10.378|
74093992|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.8|||||TWO_SIDED|95.0|1.18|2.62|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 9V: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.62|1.18|
73879744|NCT03192176|147297615|SUPERIORITY||LSMean difference|14.8|STANDARD_ERROR_OF_MEAN|6.55||0.0244|TWO_SIDED|95.0|1.92|27.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||27.70|1.92|0.0244
74012214|NCT01324232|147575174|SUPERIORITY||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.461|=|0.9427|TWO_SIDED|95.0|-0.88|0.94|||ANCOVA|||Pairwise treatment group vs placebo||0.94|-0.88|=0.9427
74012215|NCT01324232|147575174|SUPERIORITY||Adjusted mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.401|=|0.6075|TWO_SIDED|95.0|-1.0|0.58|||ANCOVA|||Pairwise treatment group vs placebo||0.58|-1.0|=0.6075
74012216|NCT01324232|147575174|SUPERIORITY||Adjusted mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.402|=|0.669|TWO_SIDED|95.0|-0.96|0.62|||ANCOVA|||Pairwise treatment group vs placebo||0.62|-0.96|=0.6690
74012217|NCT01324232|147575174|SUPERIORITY||Adjusted mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.38|=|0.7394|TWO_SIDED|95.0|-0.88|0.62|||ANCOVA|||Pairwise treatment group vs placebo||0.62|-0.88|=0.7394
74012218|NCT01324232|147575175|SUPERIORITY||||||=|0.9731|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.9731
74012219|NCT01324232|147575175|SUPERIORITY||Mean difference (final values)|1.32|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-3.46|6.09||||||||6.09|-3.46|
74012220|NCT01324232|147575175|SUPERIORITY||Mean difference (final values)|-3.0|STANDARD_ERROR_OF_MEAN|2.394|||TWO_SIDED|95.0|-7.72|1.72||||||||1.72|-7.72|
74012221|NCT01324232|147575175|SUPERIORITY||Mean difference (final values)|1.2|STANDARD_ERROR_OF_MEAN|2.408|||TWO_SIDED|95.0|-3.54|5.95||||||||5.95|-3.54|
74012222|NCT01324232|147575177|SUPERIORITY||||||=|0.4778||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.||||=0.4778
74012223|NCT01324232|147575177|SUPERIORITY||Adjusted mean difference|0.49|STANDARD_ERROR_OF_MEAN|3.676|||TWO_SIDED|95.0|-6.76|7.74||||||||7.74|-6.76|
74042569|NCT00861380|147636906|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|10.429|||||TWO_SIDED|95.0|10.259|10.601|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.601|10.259|
73879745|NCT03192176|147297615|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.46||0.0008|TWO_SIDED|95.0|9.21|34.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||34.62|9.21|0.0008
74012224|NCT01324232|147575177|SUPERIORITY||Adjusted mean difference|-1.67|STANDARD_ERROR_OF_MEAN|3.663|||TWO_SIDED|95.0|-8.89|5.56||||||||5.56|-8.89|
74012225|NCT01324232|147575177|SUPERIORITY||Adjusted mean difference|3.43|STANDARD_ERROR_OF_MEAN|3.681|||TWO_SIDED|95.0|-3.83|10.68||||||||10.68|-3.83|
74012226|NCT01324232|147575178|SUPERIORITY||||||=|0.0685|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.0685
74012227|NCT01324232|147575178|SUPERIORITY||Mean difference (final values)|-0.51|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-1.85|0.83||||||||0.83|-1.85|
74012228|NCT01324232|147575178|SUPERIORITY||Mean difference (final values)|-0.85|STANDARD_ERROR_OF_MEAN|0.677|||TWO_SIDED|95.0|-2.19|0.48||||||||0.48|-2.19|
74012229|NCT01324232|147575178|SUPERIORITY||Mean difference (final values)|-1.2|STANDARD_ERROR_OF_MEAN|0.681|||TWO_SIDED|95.0|-2.54|0.15||||||||0.15|-2.54|
74012230|NCT01324232|147575179|SUPERIORITY||||||=|0.4201|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.4201
74012231|NCT01324232|147575179|SUPERIORITY||Adjusted mean difference|-0.49|STANDARD_ERROR_OF_MEAN|1.473|||TWO_SIDED|95.0|-3.4|2.41||||||||2.41|-3.40|
74012232|NCT01324232|147575179|SUPERIORITY||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.454|||TWO_SIDED|95.0|-3.76|1.97||||||||1.97|-3.76|
74012233|NCT01324232|147575179|SUPERIORITY||Adjusted mean difference|1.46|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-1.42|4.34||||||||4.34|-1.42|
74012234|NCT01324232|147575180|SUPERIORITY||||||=|0.8068||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.||||=0.8068
74012235|NCT01324232|147575180|SUPERIORITY||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.205|||TWO_SIDED|95.0|-3.47|1.28||||||||1.28|-3.47|
74012236|NCT01324232|147575180|SUPERIORITY||Adjusted mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.0|-2.99|1.74||||||||1.74|-2.99|
74012237|NCT01324232|147575180|SUPERIORITY||Adjusted mean difference|0.31|STANDARD_ERROR_OF_MEAN|1.207|||TWO_SIDED|95.0|-2.07|2.69||||||||2.69|-2.07|
74012238|NCT01324232|147575181|SUPERIORITY||||||=|0.6315||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect. Oral responses.|ANCOVA|||||||=0.6315
74012239|NCT01324232|147575181|SUPERIORITY||Adjusted mean difference|2.37|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-3.19|7.93||||||||7.93|-3.19|
74012240|NCT01324232|147575181|SUPERIORITY||Adjusted mean difference|1.31|STANDARD_ERROR_OF_MEAN|2.562|||TWO_SIDED|95.0|-3.83|6.45||||||||6.45|-3.83|
74012241|NCT01324232|147575181|SUPERIORITY||Adjusted mean difference|1.46|STANDARD_ERROR_OF_MEAN|2.728|||TWO_SIDED|95.0|-4.01|6.94||||||||6.94|-4.01|
74012242|NCT01324232|147575181|SUPERIORITY||||||=|0.1485|TWO_SIDED|||||P-value presented tests the hypothesis for overall treatment effect versus no treatment effect. Written responses.|ANCOVA|||||||=0.1485
74012243|NCT01324232|147575181|SUPERIORITY||Mean difference (final values)|1.77|STANDARD_ERROR_OF_MEAN|1.558|||TWO_SIDED|95.0|-1.31|4.85||||||||4.85|-1.31|
74012244|NCT01324232|147575181|SUPERIORITY||Mean difference (final values)|-1.68|STANDARD_ERROR_OF_MEAN|1.605|||TWO_SIDED|95.0|-4.86|1.49||||||||1.49|-4.86|
74093993|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||TWO_SIDED|95.0|0.62|1.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 14: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.13|0.62|
74093994|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.53|2.69|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 18C: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.69|1.53|
74042570|NCT00861380|147636906|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|10.118|||||TWO_SIDED|95.0|9.997|10.239|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||10.239|9.997|
74042571|NCT00861380|147636906|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|9.921|||||TWO_SIDED|95.0|9.755|10.088|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.088|9.755|
74042572|NCT00861380|147636914|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|22.624|||||TWO_SIDED|95.0|22.02|23.24|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||23.240|22.020|
74042573|NCT00861380|147636914|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|22.747|||||TWO_SIDED|95.0|21.912|23.606|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||23.606|21.912|
74042574|NCT00861380|147636914|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|24.503|||||TWO_SIDED|95.0|23.852|25.166|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||25.166|23.852|
74042575|NCT00861380|147636914|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|26.236|||||TWO_SIDED|95.0|25.308|27.189|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||27.189|25.308|
74093995|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.37|2.1|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 19A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.10|1.37|
74093996|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.09|1.93|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 19F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.93|1.09|
74093997|NCT00546572|147738988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|7.3|||||TWO_SIDED|95.0|5.36|9.82|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 23F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||9.82|5.36|
74093998|NCT00546572|147738989|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|12.1|||||TWO_SIDED|95.0|8.92|16.44|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|"Serotype 6A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2."||16.44|8.92|
74093999|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-11.4|||<|0.001|TWO_SIDED|95.0|-17.3|-5.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-5.6|-17.3|<0.001
73879746|NCT03192176|147297615|SUPERIORITY||LSMean difference|23.2|STANDARD_ERROR_OF_MEAN|6.41||0.0003|TWO_SIDED|95.0|10.63|35.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||35.83|10.63|0.0003
74012245|NCT01324232|147575181|SUPERIORITY||Mean difference (final values)|-1.65|STANDARD_ERROR_OF_MEAN|1.549|||TWO_SIDED|95.0|-4.71|1.41||||||||1.41|-4.71|
74012246|NCT01324232|147575182|SUPERIORITY||||||=|0.1404|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 158 of the 209 participants in the mITT Population were analyzed at Day 22.||||=0.1404
74012247|NCT01324232|147575182|SUPERIORITY||||||=|0.0805|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 152 of the 209 participants in the mITT Population were analyzed at Day 50.||||=0.0805
74012248|NCT01324232|147575182|SUPERIORITY||||||=|0.0551|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 185 of the 209 participants in the mITT Population were analyzed at Day 85.||||=0.0551
74094000|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-4.0||||0.129|TWO_SIDED|95.0|-9.1|1.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||1.1|-9.1|0.129
74094001|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-6.8||||0.002|TWO_SIDED|95.0|-11.3|-2.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-2.3|-11.3|0.002
74094002|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-3.2||||0.028|TWO_SIDED|95.0|-6.3|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.3|-6.3|0.028
74094003|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-12.7|||<|0.001|TWO_SIDED|95.0|-18.5|-7.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-7.0|-18.5|<0.001
74094004|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-5.1||||0.048|TWO_SIDED|95.0|-10.2|-0.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.1|-10.2|0.048
73879747|NCT03192176|147297615|SUPERIORITY||LSMean difference|9.8|STANDARD_ERROR_OF_MEAN|7.38||0.1871|TWO_SIDED|95.0|-4.77|24.3||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||24.30|-4.77|0.1871
74012249|NCT01324232|147575183|SUPERIORITY||||||=|0.9207|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.9207
74012250|NCT00330382|147575197|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.11|||>|0.45|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in buccal-cell Neu with relative percent change in total lesion area||||>0.45
73879748|NCT03192176|147297615|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|7.38||0.7552|TWO_SIDED|95.0|-12.23|16.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMMRM|||Week 13||16.83|-12.23|0.7552
73879749|NCT03192176|147297615|SUPERIORITY||LSMean difference|1.5|STANDARD_ERROR_OF_MEAN|7.61||0.8407|TWO_SIDED|95.0|-13.44|16.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||16.50|-13.44|0.8407
74012251|NCT00330382|147575197|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.92|||>|0.88|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in protease activity with relative percent change in total lesion area||||> 0.88
74012252|NCT00330382|147575197|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.07|||>|0.66|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in serum Neu with relative percent change in total lesion area||||> 0.66
74012253|NCT02018822|147575204|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2552|||||||Chi-squared|||||||0.2552
74012254|NCT02018822|147575205|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2235|||||||Chi-squared|||||||0.2235
74012255|NCT02018822|147575206|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3891|||||||Chi-squared|||||||0.3891
74012256|NCT02018822|147575207|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared|||||||0.3883
74012257|NCT02018822|147575208|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared|||||||0.3883
74012258|NCT02018822|147575209|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2707|||||||Chi-squared|||||||0.2707
74012259|NCT03201458|147575210|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.027|TWO_SIDED|90.0|0.35|0.93||One-sided test|Log Rank|||||0.93|0.35|0.027
74012260|NCT03201458|147575211|SUPERIORITY||Odds Ratio (OR)|2.3||||0.22|TWO_SIDED||||||Fisher Exact|||||||0.22
74012261|NCT03201458|147575213|SUPERIORITY|||||||0.41||||||One-sided test|Log Rank|||||||0.410
74012262|NCT05112536|147575228|OTHER|||||||0.101|||||||Wilcoxon signed-rank test|||||||0.101
74012263|NCT01389752|147575231|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.65|||||TWO_SIDED|90.0|0.61|0.68||The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.|Mixed Models Analysis|||||0.68|0.61|
74012264|NCT01389752|147575232|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.9|||||TWO_SIDED|90.0|0.83|0.98||The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.|Mixed Models Analysis|||||0.98|0.83|
74012265|NCT01389752|147575233|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.55||||0.001|TWO_SIDED|90.0|-1.04|-0.5||The outcome was measured using the median of paired differences between the 2 treatment groups: LY2216684 administered alone (reference) versus LY2216684 co-administered with charcoal (test).|Wilcoxon (Mann-Whitney)|||||-0.50|-1.04|0.0010
74012266|NCT01594515|147575247|SUPERIORITY_OR_OTHER||Slope|0.9702|STANDARD_ERROR_OF_MEAN|0.0151|||TWO_SIDED|95.0|0.94|1.0005|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of the drug for Cmax was analysed.(N=50)||1.0005|0.9400|
74012267|NCT01594515|147575248|SUPERIORITY_OR_OTHER||Slope|1.0442|STANDARD_ERROR_OF_MEAN|0.0148|||TWO_SIDED|95.0|1.0145|1.074|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale."|This was non confirmatory testing (Single dose). Dose proportionality of the drug for AUC0-inf was analysed. (N=48)||1.0740|1.0145|
73879750|NCT03192176|147297615|SUPERIORITY||LSMean difference|7.2|STANDARD_ERROR_OF_MEAN|7.6||0.345|TWO_SIDED|95.0|-7.77|22.14||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|LSMean difference|||Week 13||22.14|-7.77|0.3450
73879751|NCT03192176|147297615|SUPERIORITY||LSMean difference|5.7|STANDARD_ERROR_OF_MEAN|7.66||0.455|TWO_SIDED|95.0|-9.34|20.8||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||20.80|-9.34|0.4550
74012268|NCT04251910|147575265|SUPERIORITY|||||||0.0813|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0813
74012269|NCT04251910|147575265|SUPERIORITY|||||||0.0011|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0011
74012270|NCT04251910|147575265|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)||||0.0002
74012271|NCT04251910|147575267|SUPERIORITY|||||||0.9616|||||||Mixed effects model|||Part A 30 mcg BXCL501 v/s Part A-Placebo (30 minutes)||||0.9616
74012272|NCT04251910|147575267|SUPERIORITY|||||||0.546|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)||||0.5460
74012273|NCT04251910|147575267|SUPERIORITY|||||||0.0961|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/s Part A-Placebo (2 hours)||||0.0961
74012274|NCT04251910|147575267|SUPERIORITY|||||||0.1359|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (4 hours)||||0.1359
74012275|NCT04251910|147575267|SUPERIORITY|||||||0.1688|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (8 hours)||||0.1688
74012276|NCT04251910|147575267|SUPERIORITY|||||||0.667|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (24 hours)||||0.6670
74012277|NCT04251910|147575267|SUPERIORITY|||||||0.8695|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 3)||||0.8695
74012278|NCT04251910|147575267|SUPERIORITY|||||||0.5002|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 7)||||0.5002
74012279|NCT04251910|147575267|SUPERIORITY|||||||0.5631|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (30 minutes)||||0.5631
74012280|NCT04251910|147575267|SUPERIORITY|||||||0.0089|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (1 hour)||||0.0089
74012281|NCT04251910|147575267|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (2 hours)||||<.0001
74012282|NCT04251910|147575267|SUPERIORITY|||||||0.0011|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (4 hours)||||0.0011
74042576|NCT00861380|147636914|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|27.502|||||TWO_SIDED|95.0|26.81|28.207|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||28.207|26.810|
74094005|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-9.6|||<|0.001|TWO_SIDED|95.0|-14.2|-5.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-5.1|-14.2|<0.001
74094006|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-4.8|||<|0.001|TWO_SIDED|95.0|-7.9|-2.7|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-2.7|-7.9|<0.001
74012283|NCT04251910|147575267|SUPERIORITY|||||||0.0008|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (8 hours)||||0.0008
74012284|NCT04251910|147575267|SUPERIORITY|||||||0.2847|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (24 hours)||||0.2847
74012285|NCT04251910|147575267|SUPERIORITY|||||||0.2616|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 3)||||0.2616
74012286|NCT04251910|147575267|SUPERIORITY|||||||0.1989|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 7)||||0.1989
74012287|NCT04251910|147575267|SUPERIORITY|||||||0.4585|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (30 minutes)||||0.4585
74012288|NCT04251910|147575267|SUPERIORITY|||||||0.0005|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (1 hour)||||0.0005
74012289|NCT04251910|147575267|SUPERIORITY|||||||0.0004|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)||||0.0004
74012290|NCT04251910|147575267|SUPERIORITY|||||||0.0025|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (4 hours)||||0.0025
74012291|NCT04251910|147575267|SUPERIORITY|||||||0.1027|TWO_SIDED|95.0|||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (8 hours)||||0.1027
74012292|NCT04251910|147575267|SUPERIORITY|||||||0.7953|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (24 hours)||||0.7953
74012293|NCT04251910|147575267|SUPERIORITY|||||||0.1416|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)||||0.1416
74012294|NCT04251910|147575267|SUPERIORITY|||||||0.0658|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)||||0.0658
74012295|NCT04251910|147575268|SUPERIORITY|||||||0.876|||||||Mixed effects model|||Part A -30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)||||0.8760
74012296|NCT04251910|147575268|SUPERIORITY|||||||0.9077|||||||Mixed effects model|||Part A 30 mcg BXCL501 v/s Part A-Placebo (Day 1; 2 hours)||||0.9077
74012297|NCT04251910|147575268|SUPERIORITY|||||||0.7208|||||||Mixed effects model|||Part A 30 mcg BXCL501 vs Part A-Placebo (Day1; 4 hours)||||0.7208
74012298|NCT04251910|147575268|SUPERIORITY|||||||0.3666|||||||Mixed effects model|||Part A BXCL501 30 mcg v/s Part A-Placebo(Day 1;8 hours)||||0.3666
74012299|NCT04251910|147575268|SUPERIORITY|||||||0.0191|||||||Mixed effects model|||Part A BXCL501 60 mcg v/s Placebo-Part A (Day1; 1 hour)||||0.0191
74012300|NCT04251910|147575268|SUPERIORITY|||||||0.0006|||||||Mixed effects model|||Part A BXCL501 60 mcg v/s Part A-Placebo (Day 1; 2 hours)||||0.0006
74012301|NCT04251910|147575268|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 1; 4 hours)||||<.0001
74012302|NCT04251910|147575268|SUPERIORITY|||||||0.0003|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1;8 hours)||||0.0003
74012303|NCT04251910|147575268|SUPERIORITY|||||||0.0006|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0006
74012304|NCT04251910|147575268|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||0.0002
74012305|NCT04251910|147575268|SUPERIORITY|||||||0.0029|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0029
74012306|NCT04251910|147575268|SUPERIORITY|||||||0.2446|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.2446
73879752|NCT03192176|147297615|SUPERIORITY||LSMean difference|10.4|STANDARD_ERROR_OF_MEAN|7.64||0.1747|TWO_SIDED|95.0|-4.64|25.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||25.44|-4.64|0.1747
73879753|NCT03192176|147297615|SUPERIORITY||LSMean difference|4.4|STANDARD_ERROR_OF_MEAN|7.38||0.5476|TWO_SIDED|95.0|-10.08|18.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||18.97|-10.08|0.5476
74012307|NCT04251910|147575269|SUPERIORITY|||||||0.0926|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.0926
74012308|NCT04251910|147575269|SUPERIORITY|||||||0.3976|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.3976
74012309|NCT04251910|147575269|SUPERIORITY|||||||0.1169|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.1169
74012310|NCT04251910|147575269|SUPERIORITY|||||||0.3786|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.3786
74012311|NCT04251910|147575269|SUPERIORITY|||||||0.564|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24hours)||||0.5640
74012312|NCT04251910|147575269|SUPERIORITY|||||||0.602|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 3)||||0.6020
74012313|NCT04251910|147575269|SUPERIORITY|||||||0.5875|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.5875
74012314|NCT04251910|147575269|SUPERIORITY|||||||0.1055|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.1055
74094007|NCT00546572|147738990|SUPERIORITY_OR_OTHER||Chan & Zhang|-6.8||||0.062|TWO_SIDED|95.0|-14.0|0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||0.4|-14.0|0.062
74012315|NCT04251910|147575269|SUPERIORITY|||||||0.0024|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.0024
74012316|NCT04251910|147575269|SUPERIORITY|||||||0.0016|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.0016
74012317|NCT04251910|147575269|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.0002
74012318|NCT04251910|147575269|SUPERIORITY|||||||0.2039|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.2039
74012319|NCT04251910|147575269|SUPERIORITY|||||||0.1948|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 3)||||0.1948
74012320|NCT04251910|147575269|SUPERIORITY|||||||0.5615|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.5615
74012321|NCT04251910|147575269|SUPERIORITY|||||||0.8266|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)||||0.8266
73879754|NCT03192176|147297615|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|8.01||0.7954|TWO_SIDED|95.0|-13.69|17.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||17.84|-13.69|0.7954
73879755|NCT03192176|147297615|SUPERIORITY||LSMean differencce|1.3|STANDARD_ERROR_OF_MEAN|7.96||0.8731|TWO_SIDED|95.0|-14.41|16.95||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||16.95|-14.41|0.8731
73879756|NCT03192176|147297615|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|8.31||0.9689|TWO_SIDED|95.0|-16.68|16.03||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||16.03|-16.68|0.9689
74012322|NCT04251910|147575269|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0002
74012323|NCT04251910|147575269|SUPERIORITY|||||||0.0004|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0004
74012324|NCT04251910|147575269|SUPERIORITY|||||||0.1037|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.1037
74012325|NCT04251910|147575269|SUPERIORITY|||||||0.3267|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)||||0.3267
74012326|NCT04251910|147575269|SUPERIORITY|||||||0.0339|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)||||0.0339
74012327|NCT04251910|147575269|SUPERIORITY|||||||0.1892|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day7)||||0.1892
74012328|NCT04251910|147575270|SUPERIORITY|||||||0.3359|||||||Fisher Exact|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)||||0.3359
74012329|NCT04251910|147575270|SUPERIORITY|||||||0.0004|||||||Fisher Exact|||Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)||||0.0004
74012330|NCT04251910|147575270|SUPERIORITY|||||||0.0351|||||||Fisher Exact|||||||0.0351
74012331|NCT04251910|147575271|SUPERIORITY|||||||0.0952|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0952
74012332|NCT04251910|147575271|SUPERIORITY|||||||0.8977|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.8977
74012333|NCT04251910|147575271|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||0.0002
74012334|NCT04251910|147575271|SUPERIORITY|||||||0.3147|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.3147
74012335|NCT04251910|147575271|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||<.0001
74012336|NCT04251910|147575271|SUPERIORITY|||||||0.1241|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)||||0.1241
74012337|NCT04251910|147575272|SUPERIORITY|||||||0.408|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.4080
74012338|NCT04251910|147575272|SUPERIORITY|||||||0.4198|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.4198
73879757|NCT03192176|147297615|SUPERIORITY||LSMean difference|3.9|STANDARD_ERROR_OF_MEAN|8.28||0.6378|TWO_SIDED|95.0|-12.4|20.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||20.21|-12.40|0.6378
73879758|NCT03192176|147297615|SUPERIORITY||LSMean differencce|1.6|STANDARD_ERROR_OF_MEAN|8.33||0.8503|TWO_SIDED|95.0|-14.82|17.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||17.97|-14.82|0.8503
73879759|NCT03192176|147297615|SUPERIORITY||LSMean difference|13.0|STANDARD_ERROR_OF_MEAN|8.37||0.1224|TWO_SIDED|95.0|-3.51|29.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||29.44|-3.51|0.1224
74042577|NCT00861380|147636914|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|26.1||||||95.0|25.171|27.055|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||27.055|25.171|
74094008|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-4.0||||0.284|TWO_SIDED|95.0|-11.3|3.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||3.3|-11.3|0.284
74012339|NCT04251910|147575272|SUPERIORITY|||||||0.037|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day1; 2 hours)||||0.0370
74012340|NCT04251910|147575272|SUPERIORITY|||||||0.1324|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.1324
74012341|NCT04251910|147575272|SUPERIORITY|||||||0.0624|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.0624
74012342|NCT04251910|147575272|SUPERIORITY|||||||0.6334|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.6334
74012343|NCT04251910|147575272|SUPERIORITY|||||||0.0275|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.0275
74012344|NCT04251910|147575272|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||<.0001
74012345|NCT04251910|147575272|SUPERIORITY|||||||0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.0001
74012346|NCT04251910|147575272|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day1; 8 hours)||||<.0001
74012347|NCT04251910|147575272|SUPERIORITY|||||||0.2806|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)||||0.2806
74012348|NCT04251910|147575272|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0002
74012349|NCT04251910|147575272|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hour)||||<.0001
74012350|NCT04251910|147575272|SUPERIORITY|||||||0.0009|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0009
74012351|NCT04251910|147575272|SUPERIORITY|||||||0.0081|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.0081
73879760|NCT03192176|147297615|SUPERIORITY||LSMean difference|7.1|STANDARD_ERROR_OF_MEAN|7.99||0.3743|TWO_SIDED|95.0|-8.62|22.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||22.85|-8.62|0.3743
74012352|NCT04251910|147575273|SUPERIORITY|||||||0.0591|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||0.0591
74012353|NCT04251910|147575273|SUPERIORITY|||||||0.0966|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.0966
74012354|NCT04251910|147575273|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||<.0001
74012355|NCT04251910|147575273|SUPERIORITY|||||||0.029|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.0290
74012356|NCT04251910|147575273|SUPERIORITY|||||||0.0937|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||0.0937
74012357|NCT04251910|147575273|SUPERIORITY|||||||0.2747|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)||||0.2747
74012358|NCT04251910|147575276|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours post administration)||||0.0002
74012359|NCT00777101|147575305|NON_INFERIORITY|Non-inferiority of neratinib vs lapatinib + capecitabine was to be concluded if the upper limit of the 95% confidence interval (CI) for the hazard ratio was 1.15 or less.|Hazard Ratio (HR)|1.19||||0.231|TWO_SIDED|95.0|0.89|1.6|||Log Rank|The log-rank test comparing treatment groups is stratified by region.|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by region.|||1.60|0.89|0.231
74094009|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-16.1|||<|0.001|TWO_SIDED|95.0|-21.7|-10.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-10.6|-21.7|<0.001
73879761|NCT03192176|147297615|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|7.89||0.3173|TWO_SIDED|95.0|-23.44|7.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||7.63|-23.44|0.3173
73879762|NCT03192176|147297615|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|7.82||0.7905|TWO_SIDED|95.0|-17.48|13.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.32|-17.48|0.7905
73879763|NCT03192176|147297615|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|8.24||0.3804|TWO_SIDED|95.0|-23.46|8.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||8.98|-23.46|0.3804
73879764|NCT03192176|147297615|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|8.11||0.4905|TWO_SIDED|95.0|-21.58|10.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||10.38|-21.58|0.4905
73879765|NCT03192176|147297615|SUPERIORITY||LSMean difference|-12.6|STANDARD_ERROR_OF_MEAN|8.25||0.1289|TWO_SIDED|95.0|-28.83|3.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||3.68|-28.83|0.1289
73879766|NCT03192176|147297615|SUPERIORITY||LSMean difference|6.4|STANDARD_ERROR_OF_MEAN|8.24||0.4398|TWO_SIDED|95.0|-9.86|22.61||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||22.61|-9.86|0.4398
74012360|NCT01301950|147575335|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANOVA|||The null hypothesis was no difference in skin-to-skin time. The alternative hypothesis was that the TruMatch group time was less than the conventional group. Statistical power was anticipated to be 86% with 40 enrolled subjects based upon a Cohen's D effect size of 1. The Sponsor had difficulty identifying and recruiting sites suitable for participation. The statistically required sample size (N=40) was therefore not obtained, causing the group comparison to be statistically underpowered.||||0.54
74012361|NCT02651584|147575340|NON_INFERIORITY|The p-value was based on the chi square test for non-inferiority with the margin of 10% point.|||||<|0.001|||||||Chi-squared|||||||<0.001
74012362|NCT02651584|147575341|SUPERIORITY|||||||0.004|||||||Wilcoxon Rank-Sum|||including subject self-reported opioid use||||0.004
74012363|NCT02651584|147575341|SUPERIORITY|||||||0.008|||||||Wilcoxon Rank-Sum|||not including self-reported opioid use||||0.008
74012364|NCT02651584|147575343|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was based on the chi square test for non-inferiority with the margin of 15%.||||||0.006|||||||Chi-squared|||||||0.006
74012365|NCT00841789|147575344|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||.10
74012366|NCT00841789|147575345|SUPERIORITY|||||||0.86|||||||Regression, Cox|||We applied a Generalized Estimating Equation (GEE) model to determine z score change values (see Protocol page 36 in Supplement).||||0.86
74012367|NCT00841789|147575346|SUPERIORITY|||||||0.83|||||||GEE|||General Estimating Equation||||.83
74012368|NCT00841789|147575346|OTHER|Generallzed Estimating Equation was used for z-score change within groups compared to baseline|General Estimating Equation|||||0.1279|||||||GEE|||We analyzed change from baseline for both etanercept and placebo. LS mean change J(standard error) reported||||0.1279
74012369|NCT00841789|147575347|OTHER|General Estimating Equation for 3 coronary arteries.||||||0.03|||||||GEE|||General Estimating Equation|Generalize estimating equation for 3 coronary arteries evaluated in each patient by echocardiography|||0.03
74012370|NCT00841789|147575347|OTHER|see above||||||0.619|||||||GEE|||GEE performed to compare with change in coronary z score from baseline||||0.619
74012371|NCT03455491|147575362|SUPERIORITY|||||||0.3541|||||||Gekhan-Wilcoxon test|||||||0.3541
74012372|NCT03455491|147575363|SUPERIORITY|||||||0.3597|||||||Gekhan-Wilcoxon test|||||||0.3597
74012373|NCT03455491|147575365|SUPERIORITY|||||||0.4551|||||||ANOVA|one-way ANOVA||||||0.4551
73879767|NCT03192176|147297615|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|7.81||0.7921|TWO_SIDED|95.0|-17.45|13.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.33|-17.45|0.7921
74012374|NCT03317795|147575381|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
74012375|NCT03317795|147575383|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
74012376|NCT03317795|147575384|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Physical composite score||||0.32
74012377|NCT03317795|147575384|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Mental composite score||||0.26
74012378|NCT03317795|147575385|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
74012379|NCT03317795|147575386|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
74012380|NCT00495820|147575400|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
74012381|NCT00495820|147575401|SUPERIORITY_OR_OTHER||||||=|0.01|||||||Mixed Models Analysis|||||||=0.01
74094010|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-0.9||||0.539|TWO_SIDED|95.0|-3.5|1.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||1.4|-3.5|0.539
74094011|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-17.1|||<|0.001|TWO_SIDED|95.0|-23.1|-11.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-11.1|-23.1|<0.001
73879768|NCT03192176|147297616|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|7.28||0.009|TWO_SIDED|95.0|4.82|33.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||33.46|4.82|0.0090
73888006|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9||||0.0091|TWO_SIDED|95.0|11.1|76.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||76.7|11.1|0.0091
74012382|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.0034||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.||||0.0034
74012383|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.26||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.||||0.2600
74012384|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated measures Analysis of Variance|||60 minutes after study drug injection.||||0.0001
74012385|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.0039||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.0039
74012386|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.93||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.9300
74012387|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.0031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.0031
74012388|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.019||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.0190
74012389|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.92||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.9200
74012390|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.015||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.0150
74012391|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.095||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.0950
74012392|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.6||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.6000
74012393|NCT00916357|147575473|SUPERIORITY_OR_OTHER|||||||0.031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.0310
74012394|NCT00916357|147575474|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
74012395|NCT00916357|147575474|SUPERIORITY_OR_OTHER|||||||0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.1800
74012396|NCT00916357|147575474|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
74012397|NCT00916357|147575475|SUPERIORITY_OR_OTHER|||||||0.0045||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0045
74012398|NCT00916357|147575475|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.4800
74012399|NCT00916357|147575475|SUPERIORITY_OR_OTHER|||||||0.0006||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.0006
74012400|NCT00916357|147575476|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
74012401|NCT00916357|147575476|SUPERIORITY_OR_OTHER|||||||0.0016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0016
74012402|NCT00916357|147575476|SUPERIORITY_OR_OTHER|||||||0.1||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.1000
74012403|NCT00916357|147575477|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone + Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
74012404|NCT00916357|147575477|SUPERIORITY_OR_OTHER|||||||0.3||||||Treatment comparison for Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.3000
74012405|NCT00916357|147575477|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
74012406|NCT00916357|147575478|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
74012407|NCT00916357|147575478|SUPERIORITY_OR_OTHER|||||||0.77||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.7700
74012408|NCT00916357|147575478|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
74012409|NCT00916357|147575479|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0100
73879769|NCT03192176|147297616|SUPERIORITY||LSMean difference|27.0|STANDARD_ERROR_OF_MEAN|7.32||0.0003|TWO_SIDED|95.0|12.61|41.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||41.39|12.61|0.0003
73879770|NCT03192176|147297616|SUPERIORITY||LSMean difference|39.5|STANDARD_ERROR_OF_MEAN|7.31|<|0.0001|TWO_SIDED|95.0|25.14|53.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||53.90|25.14|<0.0001
73879771|NCT03192176|147297616|SUPERIORITY||LSMean difference|44.8|STANDARD_ERROR_OF_MEAN|7.4|<|0.0001|TWO_SIDED|95.0|30.27|59.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||59.39|30.27|<0.0001
73879772|NCT03192176|147297616|SUPERIORITY||LSMean difference|12.2|STANDARD_ERROR_OF_MEAN|7.43||0.1019|TWO_SIDED|95.0|-2.43|26.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||26.79|-2.43|0.1019
73879773|NCT03192176|147297616|SUPERIORITY||LSMean difference|27.8|STANDARD_ERROR_OF_MEAN|7.31||0.0002|TWO_SIDED|95.0|13.45|42.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||42.22|13.45|0.0002
73879774|NCT03192176|147297616|SUPERIORITY||LSMean difference|29.5|STANDARD_ERROR_OF_MEAN|7.27|<|0.0001|TWO_SIDED|95.0|15.21|43.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||43.82|15.21|<0.0001
73879775|NCT03192176|147297616|SUPERIORITY||LSMean difference|19.9|STANDARD_ERROR_OF_MEAN|7.03||0.0049|TWO_SIDED|95.0|6.1|33.76||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||33.76|6.10|0.0049
73879776|NCT03192176|147297616|SUPERIORITY||LSMean difference|28.6|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|14.64|42.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||42.46|14.64|<0.0001
73879777|NCT03192176|147297616|SUPERIORITY||LSMean differencce|33.8|STANDARD_ERROR_OF_MEAN|7.05|<|0.0001|TWO_SIDED|95.0|19.96|47.69||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||47.69|19.96|<0.0001
73879778|NCT03192176|147297616|SUPERIORITY||LSMean difference|39.5|STANDARD_ERROR_OF_MEAN|7.16|<|0.0001|TWO_SIDED|95.0|25.4|53.58||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||53.58|25.40|<0.0001
73879779|NCT03192176|147297616|SUPERIORITY||LSMean difference|17.6|STANDARD_ERROR_OF_MEAN|7.17||0.0146|TWO_SIDED|95.0|3.5|31.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||31.70|3.50|0.0146
73879780|NCT03192176|147297616|SUPERIORITY||LSMean difference|24.1|STANDARD_ERROR_OF_MEAN|7.06||0.0007|TWO_SIDED|95.0|10.21|38.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||38.00|10.21|0.0007
74012410|NCT00916357|147575479|SUPERIORITY_OR_OTHER|||||||0.82||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.8200
74012411|NCT00916357|147575479|SUPERIORITY_OR_OTHER|||||||0.0056||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.0056
74012412|NCT00916357|147575480|SUPERIORITY_OR_OTHER|||||||0.064||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.064
74094012|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-14.9|||<|0.001|TWO_SIDED|95.0|-20.8|-9.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-9.0|-20.8|<0.001
73879781|NCT03192176|147297616|SUPERIORITY||LSMean difference|23.9|STANDARD_ERROR_OF_MEAN|7.03||0.0008|TWO_SIDED|95.0|10.05|37.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||37.70|10.05|0.0008
73879782|NCT03192176|147297616|SUPERIORITY||LSMean difference|23.2|STANDARD_ERROR_OF_MEAN|7.46||0.002|TWO_SIDED|95.0|8.56|37.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||37.90|8.56|0.0020
73879783|NCT03192176|147297616|SUPERIORITY||LSMean difference|34.4|STANDARD_ERROR_OF_MEAN|7.5|<|0.0001|TWO_SIDED|95.0|19.6|49.11||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||49.11|19.60|<0.0001
74094013|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-2.3||||0.02|TWO_SIDED|95.0|-4.8|-0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.4|-4.8|0.020
74094014|NCT00546572|147738990|SUPERIORITY_OR_OTHER||difference in proportions|-2.3||||0.042|TWO_SIDED|95.0|-4.9|-0.1|||Limitation of arm movement: any; differe||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.1|-4.9|0.042
74094015|NCT00546572|147738995|SUPERIORITY_OR_OTHER||difference in proportions|-7.9||||0.034|TWO_SIDED|95.0|-15.2|-0.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|New generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.6|-15.2|0.034
74094016|NCT00546572|147738995|SUPERIORITY_OR_OTHER||difference in proportions|-6.9||||0.039|TWO_SIDED|95.0|-13.6|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Aggravated generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.3|-13.6|0.039
74094017|NCT00741936|147739015|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
74094018|NCT00741936|147739016|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.||||||<0.05
74094019|NCT00741936|147739017|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline||||||<0.05
74094020|NCT00741936|147739018|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.||||||<0.05
74094021|NCT00741936|147739019|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between two treatment groups in each time frame.||||||<0.05
74094022|NCT00741936|147739020|SUPERIORITY_OR_OTHER|||||||0||95.0|||||simple percentage|||||||0
74094023|NCT00741936|147739021|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
74094024|NCT00741936|147739022|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-samples t-test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
74094025|NCT00741936|147739023|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
74094026|NCT00741936|147739024|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
74094027|NCT00741936|147739025|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
74094028|NCT01941940|147739029|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094029|NCT01941940|147739035|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094030|NCT01941940|147739037|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094031|NCT01941940|147739037|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094032|NCT01941940|147739037|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094033|NCT01941940|147739038|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094034|NCT01941940|147739038|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094035|NCT01941940|147739038|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094036|NCT01941940|147739041|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094037|NCT01941940|147739041|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094038|NCT01941940|147739041|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094039|NCT01941940|147739041|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
73879784|NCT03192176|147297616|SUPERIORITY||LSMean difference|35.6|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|20.96|50.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||50.32|20.96|<0.0001
74012413|NCT00916357|147575480|SUPERIORITY_OR_OTHER|||||||0.47||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.47
74012414|NCT00916357|147575480|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.012
74012415|NCT00916357|147575480|SUPERIORITY_OR_OTHER|||||||0.099||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.099
74012416|NCT00916357|147575480|SUPERIORITY_OR_OTHER|||||||0.46||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.46
74012417|NCT00916357|147575480|SUPERIORITY_OR_OTHER|||||||0.02||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.020
74012418|NCT00916357|147575480|SUPERIORITY_OR_OTHER|||||||0.13||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.13
74012419|NCT00916357|147575480|SUPERIORITY_OR_OTHER|||||||0.41||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.41
74012420|NCT00916357|147575480|SUPERIORITY_OR_OTHER|||||||0.46||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.46
74012421|NCT00916357|147575481|SUPERIORITY_OR_OTHER|||||||0.016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.016
74012422|NCT00916357|147575481|SUPERIORITY_OR_OTHER|||||||0.88||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.8800
74012423|NCT00916357|147575481|SUPERIORITY_OR_OTHER|||||||0.011||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.011
74012424|NCT00916357|147575483|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||<0.0001
74094040|NCT01941940|147739041|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094041|NCT01941940|147739041|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74012425|NCT00916357|147575483|SUPERIORITY_OR_OTHER|||||||0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||0.1800
74012426|NCT00916357|147575483|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||<0.0001
74012427|NCT00916357|147575483|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison for Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||<0.0001
74012428|NCT00916357|147575483|SUPERIORITY_OR_OTHER|||||||0.72||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||0.7200
74012429|NCT00916357|147575483|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||<0.0001
74012430|NCT02495844|147575491|SUPERIORITY||Odds Ratio (OR)|4.14|||=|0.0679|TWO_SIDED|95.0|0.9|19.06|||Regression, Logistic|||||19.06|0.90|=0.0679
74012431|NCT03118232|147575504|OTHER|The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.|Difference in Risk Ratio|16.6|||<|0.001|TWO_SIDED|95.0|11.0|21.8|||Mixed Models Analysis|||||21.8|11.0|<0.001
74012432|NCT03118232|147575505|OTHER|The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.|Difference in Risk Ratio|14.6|||<|0.001|TWO_SIDED|95.0|9.7|19.2|||Mixed Models Analysis|||||19.2|9.7|<0.001
74012433|NCT02325219|147575510|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
74012434|NCT02325219|147575510|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
74012435|NCT02325219|147575511|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
74012436|NCT02325219|147575511|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
74094042|NCT01941940|147739042|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094043|NCT01941940|147739042|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
73879785|NCT03192176|147297616|SUPERIORITY||LSMean difference|43.0|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|28.03|57.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||57.93|28.03|<0.0001
73879786|NCT03192176|147297616|SUPERIORITY||LSMean difference|25.4|STANDARD_ERROR_OF_MEAN|7.6||0.0009|TWO_SIDED|95.0|10.48|40.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||40.37|10.48|0.0009
73879787|NCT03192176|147297616|SUPERIORITY||LSMean difference|31.2|STANDARD_ERROR_OF_MEAN|7.48|<|0.0001|TWO_SIDED|95.0|16.49|45.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||45.90|16.49|<0.0001
73879788|NCT03192176|147297616|SUPERIORITY||LSMean difference|28.9|STANDARD_ERROR_OF_MEAN|7.44||0.0001|TWO_SIDED|95.0|14.24|43.52||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||43.52|14.24|0.0001
73879789|NCT03192176|147297616|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|7.42||0.0021|TWO_SIDED|95.0|8.46|37.66||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||37.66|8.46|0.0021
74012437|NCT02918864|147575557|SUPERIORITY||Beta Coefficient|-0.22||||0.037|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.037
74012438|NCT02918864|147575559|SUPERIORITY||Beta Coefficient|-0.23||||0.016|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.016
74012439|NCT02918864|147575561|SUPERIORITY||Beta Coefficient|-0.16||||0.061|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.061
74012440|NCT02918864|147575563|SUPERIORITY||Beta Coefficient|0.03||||0.674|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.674
73879790|NCT03192176|147297616|SUPERIORITY||LSMean difference|32.1|STANDARD_ERROR_OF_MEAN|7.45|<|0.0001|TWO_SIDED|95.0|17.42|46.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||46.71|17.42|<0.0001
74012441|NCT02918864|147575565|SUPERIORITY||Beta Coefficient|0.09||||0.191|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.191
74012442|NCT02918864|147575567|SUPERIORITY||Beta Coefficient|0.04||||0.599|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||H0=No significant interaction of Group\*Time||||0.599
74012443|NCT02918864|147575569|SUPERIORITY|||||||0.462||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 12"||||0.462
74012444|NCT02918864|147575570|SUPERIORITY|||||||1||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 16"||||1.000
74012445|NCT02918864|147575571|SUPERIORITY|||||||0.607||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 24"||||0.607
74012446|NCT02918864|147575572|SUPERIORITY||Beta Coefficient|-0.15||||0.31|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.310
74012447|NCT02918864|147575574|SUPERIORITY||Beta Coefficient|-0.2||||0.115|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.115
74012448|NCT02918864|147575576|SUPERIORITY||Beta Coefficient|-0.08||||0.455|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.455
74012449|NCT02918864|147575578|SUPERIORITY||Beta Coefficient|-0.14||||0.379|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.379
74012450|NCT02918864|147575580|SUPERIORITY||Beta Coefficient|-0.14||||0.275|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.275
74012451|NCT02918864|147575582|SUPERIORITY||Beta Coefficient|-0.2||||0.087|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||||||0.087
74012452|NCT02257372|147575601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|||<|0.001|TWO_SIDED|95.0|0.071|0.174|||Mixed model repeated measures analysis|||||0.174|0.071|<0.001
74012453|NCT02257372|147575602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|||<|0.001|TWO_SIDED|95.0|0.099|0.197|||Mixed model repeated measures analysis|||||0.197|0.099|<0.001
74012454|NCT02634151|147575605|SUPERIORITY||LS Mean Difference|-11.05||||0.0057|TWO_SIDED|95.0|-18.81|-3.29|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||A 2-sided test with a significance level of 0.05 was used for the comparison.||-3.29|-18.81|0.0057
74012455|NCT02634151|147575606|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.8||||0.0648|TWO_SIDED|95.0|-24.35|0.75|||ANCOVA|Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.||High-Intensity.||0.75|-24.35|0.0648
74012456|NCT02634151|147575606|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.64||||0.0398|TWO_SIDED|95.0|-20.77|-0.51|||ANCOVA|Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.||Moderate Intensity.||-0.51|-20.77|0.0398
74012457|NCT02634151|147575607|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.09||||0.0275|TWO_SIDED|95.0|-19.04|-1.14|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.14|-19.04|0.0275
74012458|NCT02634151|147575607|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.4||||0.0524|TWO_SIDED|95.0|-18.9|0.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4.||0.10|-18.90|0.0524
74012459|NCT02634151|147575607|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.89||||0.8602|TWO_SIDED|95.0|-9.12|10.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||10.90|-9.12|0.8602
74012460|NCT02634151|147575607|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.63||||0.0115|TWO_SIDED|95.0|-22.37|-2.89|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-2.89|-22.37|0.0115
74012461|NCT02634151|147575607|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-5.87||||0.1945|TWO_SIDED|95.0|-14.79|3.05|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Average of week 8 and 12||3.05|-14.79|0.1945
74012462|NCT02634151|147575608|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-5.88||||0.0991|TWO_SIDED|95.0|-12.89|1.13|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||1.13|-12.89|0.0991
74094044|NCT01941940|147739042|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74012463|NCT02634151|147575609|OTHER|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.58||||0.0101|TWO_SIDED|95.0|-13.32|-1.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.84|-13.32|0.0101
74012464|NCT02634151|147575609|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.56||||0.0037|TWO_SIDED|95.0|-15.94|-3.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.18|-15.94|0.0037
74012465|NCT02634151|147575609|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.94||||0.7839|TWO_SIDED|95.0|-7.72|5.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||5.84|-7.72|0.7839
74012466|NCT02634151|147575609|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.69||||0.0025|TWO_SIDED|95.0|-17.53|-3.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-3.84|-17.53|0.0025
74012467|NCT02634151|147575610|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.66||||0.0117|TWO_SIDED|95.0|-22.45|-2.88|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-2.88|-22.45|0.0117
74012468|NCT02634151|147575610|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.55||||0.0036|TWO_SIDED|95.0|-25.88|-5.21|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-5.21|-25.88|0.0036
74012469|NCT02634151|147575610|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.59||||0.9147|TWO_SIDED|95.0|-11.48|10.31||Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.|ANCOVA|||Week 8||10.31|-11.48|0.9147
74012470|NCT02634151|147575610|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-16.59||||0.0026|TWO_SIDED|95.0|-27.24|-5.93|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-5.93|-27.24|0.0026
74012471|NCT02634151|147575611|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.13||||0.0101|TWO_SIDED|95.0|-10.77|-1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.50|-10.77|0.0101
74012472|NCT02634151|147575611|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.73||||0.0036|TWO_SIDED|95.0|-12.89|-2.58|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-2.58|-12.89|0.0036
74012473|NCT02634151|147575611|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.12||||0.9653|TWO_SIDED|95.0|-5.27|5.51|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||5.51|-5.27|0.9653
74012474|NCT02634151|147575611|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.89||||0.0101|TWO_SIDED|95.0|-12.1|-1.68|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-1.68|-12.10|0.0101
74012475|NCT02634151|147575612|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.74||||0.0173|TWO_SIDED|95.0|-23.19|-2.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-2.30|-23.19|0.0173
74012476|NCT02634151|147575612|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-16.29||||0.0038|TWO_SIDED|95.0|-27.17|-5.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-5.40|-27.17|0.0038
74012477|NCT02634151|147575612|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.58||||0.7846|TWO_SIDED|95.0|-9.85|13.01|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||13.01|-9.85|0.7846
74012478|NCT02634151|147575612|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-13.98||||0.0121|TWO_SIDED|95.0|-24.83|-3.13|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-3.13|-24.83|0.0121
74012479|NCT02634151|147575613|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-13.32||||0.0108|TWO_SIDED|95.0|-23.32|-3.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-3.12|-23.32|0.0108
74012480|NCT02634151|147575613|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-23.6|||<|0.0001|TWO_SIDED|95.0|-34.78|-12.42|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-12.42|-34.78|<0.0001
74094045|NCT01941940|147739042|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094046|NCT01941940|147739042|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74012481|NCT02634151|147575613|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.71||||0.1376|TWO_SIDED|95.0|-15.6|2.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.18|-15.60|0.1376
74042578|NCT00861380|147636914|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|28.661|||||TWO_SIDED|95.0|27.958|29.377|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||29.377|27.958|
74042579|NCT00861380|147636914|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|29.835|||||TWO_SIDED|95.0|28.843|30.85|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||30.850|28.843|
74094047|NCT01941940|147739042|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094048|NCT01941940|147739043|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 2||||<0.0001
74094049|NCT01941940|147739043|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 24||||<0.0001
74094050|NCT01941940|147739043|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 52||||<0.0001
74012482|NCT02634151|147575613|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.64||||0.0144|TWO_SIDED|95.0|-28.1|-3.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||-3.18|-28.10|0.0144
74012483|NCT02634151|147575614|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-19.53||||0.0113|TWO_SIDED|95.0|-34.55|-4.51|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-4.51|-34.55|0.0113
74094051|NCT01941940|147739044|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 2||||<0.0001
74012484|NCT02634151|147575614|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-33.64||||0.0002|TWO_SIDED|95.0|-50.58|-16.69|||ANCOVA|||Week 4||-16.69|-50.58|0.0002
74012485|NCT02634151|147575614|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-8.33||||0.1873|TWO_SIDED|95.0|-20.77|4.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||4.12|-20.77|0.1873
74012486|NCT02634151|147575614|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-29.58||||0.0172|TWO_SIDED|95.0|-53.8|-5.37|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-5.37|-53.80|0.0172
74094052|NCT01941940|147739044|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 24||||<0.0001
74094053|NCT01941940|147739044|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 52||||<0.0001
74012487|NCT02634151|147575615|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.52||||0.021|TWO_SIDED|95.0|-21.27|-1.77|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.77|-21.27|0.0210
74012488|NCT02634151|147575615|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-23.01|||<|0.0001|TWO_SIDED|95.0|-34.02|-12.01|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-12.01|-34.02|<0.0001
74094054|NCT01941940|147739045|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 2||||<0.0001
74094055|NCT01941940|147739045|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 24||||<0.0001
74094056|NCT01941940|147739045|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 52||||<0.0001
74012489|NCT02634151|147575615|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.43||||0.1483|TWO_SIDED|95.0|-15.19|2.33|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.33|-15.19|0.1483
74012490|NCT02634151|147575615|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.63||||0.0214|TWO_SIDED|95.0|-21.5|-1.76|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-1.76|-21.50|0.0214
74012491|NCT02634151|147575616|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-2.95||||0.0308|TWO_SIDED|95.0|-5.62|-0.28|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-0.28|-5.62|0.0308
74012492|NCT02634151|147575616|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.3||||0.0002|TWO_SIDED|95.0|-9.56|-3.04|||ANCOVA|A 2-sided test with a significance level of 0.05 was used for the comparison.||Week 4||-3.04|-9.56|0.0002
74012493|NCT02634151|147575616|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.58||||0.2056|TWO_SIDED|95.0|-4.03|0.88|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.88|-4.03|0.2056
74012494|NCT02634151|147575616|SUPERIORITY||LS Mean Difference|-4.0||||0.0103|TWO_SIDED|95.0|-7.04|-0.96|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-0.96|-7.04|0.0103
74012495|NCT02634151|147575617|SUPERIORITY||LS Mean Difference|-2.13||||0.3193|TWO_SIDED|95.0|-6.36|2.09|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||2.09|-6.36|0.3193
74012496|NCT02634151|147575617|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-2.4||||0.2932|TWO_SIDED|95.0|-6.91|2.11|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||2.11|-6.91|0.2932
74012497|NCT02634151|147575617|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.98||||0.4383|TWO_SIDED|95.0|-3.06|7.02|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||7.02|-3.06|0.4383
74012498|NCT02634151|147575617|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|2.78||||0.2814|TWO_SIDED|95.0|-2.31|7.86|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.86|-2.31|0.2814
74012499|NCT02634151|147575618|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.92||||0.4278|TWO_SIDED|95.0|-3.23|1.38|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||1.38|-3.23|0.4278
74012500|NCT02634151|147575618|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.13||||0.3529|TWO_SIDED|95.0|-3.53|1.27|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.27|-3.53|0.3529
74012501|NCT02634151|147575618|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.24||||0.3522|TWO_SIDED|95.0|-1.39|3.86|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.86|-1.39|0.3522
74012502|NCT02634151|147575618|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.6||||0.2635|TWO_SIDED|95.0|-1.22|4.42|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||4.42|-1.22|0.2635
74012503|NCT02634151|147575619|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.23||||0.0464|TWO_SIDED|95.0|1.01|4.93|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||4.93|1.01|0.0464
74012504|NCT02634151|147575619|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.3||||0.5278|TWO_SIDED|95.0|0.58|2.92|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.92|0.58|0.5278
74042580|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|816.813|||||TWO_SIDED|95.0|815.226|818.392|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||818.392|815.226|
74094057|NCT01941940|147739046|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 2||||<0.0001
74094058|NCT01941940|147739046|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 2||||<0.0001
74094059|NCT01941940|147739046|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 2||||<0.0001
74094060|NCT01941940|147739046|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 24||||<0.0001
74012505|NCT02634151|147575619|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.36||||0.0359|TWO_SIDED|95.0|1.06|5.27|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||5.27|1.06|0.0359
74012506|NCT02634151|147575620|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.5||||0.0268|TWO_SIDED|95.0|1.11|5.61|||Regression, Logistic|||Week 4||5.61|1.11|0.0268
74012507|NCT02634151|147575620|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2755|TWO_SIDED|95.0|0.7|3.41|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.41|0.70|0.2755
74012508|NCT02634151|147575620|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|4.74||||0.0003|TWO_SIDED|95.0|2.05|10.94|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||10.94|2.05|0.0003
74012509|NCT02634151|147575621|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.26||||0.0079|TWO_SIDED|95.0|1.36|7.8|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||7.80|1.36|0.0079
74012510|NCT02634151|147575621|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.44||||0.4002|TWO_SIDED|95.0|0.62|3.35|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.35|0.62|0.4002
74012511|NCT02634151|147575621|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.09||||0.0142|TWO_SIDED|95.0|1.25|7.59|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.59|1.25|0.0142
74012512|NCT02634151|147575622|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.7||||0.0115|TWO_SIDED|95.0|1.34|10.2|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||10.20|1.34|0.0115
74012513|NCT02634151|147575622|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.15||||0.7566|TWO_SIDED|95.0|0.48|2.75|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.75|0.48|0.7566
74012514|NCT02634151|147575622|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.96||||0.0298|TWO_SIDED|95.0|1.11|7.88|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.88|1.11|0.0298
74012515|NCT02634151|147575623|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.4||||0.0029|TWO_SIDED|95.0|-17.2|-3.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.7|-17.2|0.0029
74012516|NCT02634151|147575623|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-4.3||||0.1666|TWO_SIDED|95.0|-10.4|1.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||1.8|-10.4|0.1666
74012517|NCT02634151|147575623|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.5||||0.001|TWO_SIDED|95.0|-18.2|-4.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-4.8|-18.2|0.0010
74012518|NCT02634151|147575624|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.7||||0.0018|TWO_SIDED|95.0|-17.3|-4.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-4.1|-17.3|0.0018
74012519|NCT02634151|147575624|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-3.8||||0.2437|TWO_SIDED|95.0|-10.1|2.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.6|-10.1|0.2437
74012520|NCT02634151|147575624|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.6||||0.0012|TWO_SIDED|95.0|-18.5|-4.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-4.7|-18.5|0.0012
74012521|NCT02634151|147575625|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.7||||0.6832|TWO_SIDED|95.0|-4.2|2.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||2.8|-4.2|0.6832
74012522|NCT02634151|147575625|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.674|TWO_SIDED|95.0|-2.9|4.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||4.5|-2.9|0.6740
74012523|NCT02634151|147575625|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.9||||0.3379|TWO_SIDED|95.0|-2.0|5.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||5.7|-2.0|0.3379
74012524|NCT02634151|147575626|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.7||||0.7753|TWO_SIDED|95.0|-5.9|4.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||4.4|-5.9|0.7753
74012525|NCT02634151|147575626|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.5472|TWO_SIDED|95.0|-3.9|7.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||7.4|-3.9|0.5472
74012526|NCT02634151|147575626|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|3.6||||0.2406|TWO_SIDED|95.0|-2.4|9.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||9.6|-2.4|0.2406
74042581|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|841.176|||||TWO_SIDED|95.0|839.098|843.239|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||843.239|839.098|
74042582|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|702.245|||||TWO_SIDED|95.0|700.372|704.114|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for Acute Otitis Media (AOM)/Respiratory Tract Infections (RTI), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||704.114|700.372|
74042583|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|720.9|||||TWO_SIDED|95.0|718.355|723.435|||negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||723.435|718.355|
74042584|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|929.844|||||TWO_SIDED|95.0|928.755|930.923|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||930.923|928.755|
74042585|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|953.025|||||TWO_SIDED|95.0|951.77|954.257|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||954.257|951.770|
74094061|NCT01941940|147739046|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 24||||<0.0001
74094062|NCT01941940|147739046|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 24||||<0.0001
74094063|NCT01941940|147739046|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 52||||0.0004
74012527|NCT02634151|147575627|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.2||||0.9028|TWO_SIDED|95.0|-3.3|3.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||3.8|-3.3|0.9028
74012528|NCT02634151|147575627|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|5.2||||0.0199|TWO_SIDED|95.0|0.8|9.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||9.6|0.8|0.0199
74012529|NCT02634151|147575627|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.6||||0.0369|TWO_SIDED|95.0|0.3|8.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||8.9|0.3|0.0369
73879791|NCT03192176|147297616|SUPERIORITY||LSMean difference|31.3|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.73|45.91||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||45.91|16.73|<0.0001
74012530|NCT02634151|147575628|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.1||||0.911|TWO_SIDED|95.0|-1.2|1.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.4|-1.2|0.9110
74012531|NCT02634151|147575628|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.9||||0.0243|TWO_SIDED|95.0|0.3|3.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.5|0.3|0.0243
74012532|NCT02634151|147575628|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.0388|TWO_SIDED|95.0|0.1|3.2|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||3.2|0.1|0.0388
74012533|NCT02634151|147575629|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|7.0||||0.2799|TWO_SIDED|95.0|-5.7|19.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||19.6|-5.7|0.2799
74094064|NCT01941940|147739046|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 52||||0.0004
74012534|NCT02634151|147575629|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|26.8||||0.0018|TWO_SIDED|95.0|10.2|43.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||43.3|10.2|0.0018
74012535|NCT02634151|147575629|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|20.1||||0.0197|TWO_SIDED|95.0|3.3|36.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||36.9|3.3|0.0197
74012536|NCT02634151|147575630|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.6||||0.0179|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.0|0.1|0.0179
74012537|NCT02634151|147575630|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.1||||0.0003|TWO_SIDED|95.0|0.5|1.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||1.7|0.5|0.0003
74012538|NCT02634151|147575630|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.0095|TWO_SIDED|95.0|0.2|1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||1.5|0.2|0.0095
74012539|NCT02634151|147575631|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.2||||0.0057|TWO_SIDED|95.0|-20.8|-3.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.6|-20.8|0.0057
74012540|NCT02634151|147575631|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.2||||0.9665|TWO_SIDED|95.0|-8.3|8.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||8.6|-8.3|0.9665
74012541|NCT02634151|147575631|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.2||||0.2358|TWO_SIDED|95.0|-16.4|4.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||4.1|-16.4|0.2358
74012542|NCT02634151|147575632|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.3||||0.0048|TWO_SIDED|95.0|-2.3|-0.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-0.4|-2.3|0.0048
74012543|NCT02634151|147575632|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.1||||0.9064|TWO_SIDED|95.0|-0.9|0.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.8|-0.9|0.9064
74012544|NCT02634151|147575632|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6||||0.2505|TWO_SIDED|95.0|-1.7|0.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||0.4|-1.7|0.2505
74012545|NCT02634151|147575633|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|95.0|-22.6|-9.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-9.0|-22.6|<0.0001
74012546|NCT02634151|147575633|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.2||||0.0406|TWO_SIDED|95.0|-14.0|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||-0.3|-14.0|0.0406
74094065|NCT01941940|147739046|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 52||||0.0004
74094066|NCT01941940|147739047|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 2||||<0.0001
74094067|NCT01941940|147739047|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 24||||<0.0001
74094068|NCT01941940|147739047|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 52||||<0.0001
74094069|NCT01941940|147739048|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 2||||<0.0001
74094070|NCT01941940|147739048|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 2||||<0.0001
74094071|NCT01941940|147739048|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 2||||<0.0001
74094072|NCT01941940|147739048|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 24||||<0.0001
74094073|NCT01941940|147739048|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 24||||<0.0001
74094074|NCT01941940|147739048|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 24||||<0.0001
74094075|NCT01941940|147739048|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 52||||<0.0001
74094076|NCT01941940|147739048|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 52||||<0.0001
74094077|NCT01941940|147739048|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 52||||<0.0001
74094078|NCT01941940|147739049|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 2||||<0.0001
74094079|NCT01941940|147739049|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 24||||<0.0001
74094080|NCT01941940|147739049|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 52||||<0.0001
74094081|NCT01941940|147739050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 2||||<0.0001
74094082|NCT01941940|147739050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 2||||<0.0001
74094083|NCT01941940|147739050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 2||||<0.0001
74094084|NCT01941940|147739050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 24||||<0.0001
74094085|NCT01941940|147739050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 24||||<0.0001
74094086|NCT01941940|147739050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 24||||<0.0001
74094087|NCT01941940|147739050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 52||||<0.0001
74094088|NCT01941940|147739050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 52||||<0.0001
74094089|NCT01941940|147739050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 52||||<0.0001
74094090|NCT01941940|147739051|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 2||||<0.0001
74094091|NCT01941940|147739051|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 24||||<0.0001
73879792|NCT03192176|147297616|SUPERIORITY||LSMean difference|41.8|STANDARD_ERROR_OF_MEAN|7.56|<|0.0001|TWO_SIDED|95.0|26.95|56.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||56.68|26.95|<0.0001
74012547|NCT02634151|147575633|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.3|||<|0.0001|TWO_SIDED|95.0|-22.8|-7.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-7.8|-22.8|<0.0001
74012548|NCT02634151|147575634|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-0.3|-0.9|<0.0001
74012549|NCT02634151|147575634|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.3||||0.0771|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.0|-0.6|0.0771
74012550|NCT02634151|147575634|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6||||0.0006|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-0.3|-1.0|0.0006
74012551|NCT02634151|147575635|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|8.6||||0.121|TWO_SIDED|95.0|-2.3|19.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||19.6|-2.3|0.1210
74012552|NCT02634151|147575635|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|8.0||||0.0948|TWO_SIDED|95.0|-1.4|17.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||17.3|-1.4|0.0948
74012553|NCT02634151|147575635|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.1||||0.5113|TWO_SIDED|95.0|-8.2|16.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||16.4|-8.2|0.5113
74012554|NCT02634151|147575636|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.7276|TWO_SIDED|95.0|-7.8|11.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||11.1|-7.8|0.7276
74012555|NCT02634151|147575636|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.7||||0.2218|TWO_SIDED|95.0|-2.9|12.2|||ANCOVA|||Week 8||12.2|-2.9|0.2218
74012556|NCT02634151|147575636|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.3||||0.942|TWO_SIDED|95.0|-9.2|9.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||9.8|-9.2|0.9420
74012557|NCT02634151|147575637|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|32.57||||0.6786|TWO_SIDED|95.0|-122.98|188.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||188.12|-122.98|0.6786
74012558|NCT02634151|147575638|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.84||||0.1648|TWO_SIDED|95.0|-2.03|0.35|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||0.35|-2.03|0.1648
74012559|NCT02634151|147575639|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|41.5||||0.4701|TWO_SIDED|95.0|-72.1|155.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||155.1|-72.1|0.4701
74012560|NCT02634151|147575640|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-32.4||||0.0517|TWO_SIDED|95.0|-65.1|0.2|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||0.2|-65.1|0.0517
74012561|NCT02634151|147575641|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.5||||0.9111|TWO_SIDED|95.0|-177.8|158.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||158.8|-177.8|0.9111
74012562|NCT02634151|147575642|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-3.0||||0.3864|TWO_SIDED|95.0|-10.0|3.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||3.9|-10.0|0.3864
74012563|NCT02634151|147575643|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|12.2||||0.0145|TWO_SIDED|95.0|2.5|22.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||22.0|2.5|0.0145
74012564|NCT02634151|147575644|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.051|TWO_SIDED|95.0|0.0|1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||1.5|-0.0|0.0510
74012565|NCT02347098|147575646|SUPERIORITY|||||||0.2533|||||||t-test, 2 sided|||||||0.2533
74012566|NCT02347098|147575647|SUPERIORITY|||||||0.779|||||||t-test, 2 sided|||||||0.7790
74012567|NCT02347098|147575648|SUPERIORITY|||||||0.4549||||||The p-value reported compares the trends of outcome across time (baseline pre-PCI, baseline post-PCI, 30-day follow-up, and 90-day follow-up) between treatment groups using the repeated measurement analysis.|Mixed Models Analysis|||||||0.4549
74012568|NCT02347098|147575649|SUPERIORITY|||||||0.2663|||||||Fisher Exact|||||||0.2663
74094092|NCT01941940|147739051|SUPERIORITY_OR_OTHER|||||||0.0016|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 52||||0.0016
74094093|NCT01941940|147739054|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094094|NCT01941940|147739054|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094095|NCT01941940|147739054|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094096|NCT01941940|147739055|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094097|NCT01941940|147739055|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094098|NCT01941940|147739055|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094099|NCT01941940|147739056|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094100|NCT01941940|147739056|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74012569|NCT02187172|147575650|SUPERIORITY||Mean Difference (Final Values)|-0.2456|STANDARD_ERROR_OF_MEAN|0.07||0.0012|TWO_SIDED|95.0|-0.3873|-0.104|||Regression, Linear|||Comparison during RCT period||-0.1040|-0.3873|0.0012
74012570|NCT02187172|147575650|SUPERIORITY||Mean Difference (Final Values)|-0.0151|STANDARD_ERROR_OF_MEAN|0.0353||0.6718|TWO_SIDED|95.0|-0.0867|0.0565|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.0565|-0.0867|0.6718
74012571|NCT02187172|147575651|SUPERIORITY||Mean Difference (Final Values)|-64.97|STANDARD_ERROR_OF_MEAN|44.88||0.1159|TWO_SIDED|95.0|-115.83|25.89|||Regression, Linear|||Comparison during RCT period||25.89|-115.83|0.1159
74012572|NCT02187172|147575651|SUPERIORITY||Mean Difference (Final Values)|6.65|STANDARD_ERROR_OF_MEAN|22.24||0.7666|TWO_SIDED|95.0|-38.41|51.72|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||51.72|-38.41|0.7666
74012573|NCT02187172|147575652|SUPERIORITY||Mean Difference (Final Values)|-80.89|STANDARD_ERROR_OF_MEAN|30.46||0.0115|TWO_SIDED|95.0|-142.55|-19.23|||Regression, Linear|||Comparison during RCT period||-19.23|-142.55|0.0115
74094101|NCT01941940|147739056|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094102|NCT01941940|147739057|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094103|NCT01941940|147739057|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094104|NCT01941940|147739057|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094105|NCT01941940|147739059|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094106|NCT01941940|147739059|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094107|NCT01941940|147739059|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
74094108|NCT01941940|147739060|SUPERIORITY_OR_OTHER|||||||0.0045|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||0.0045
74094109|NCT01941940|147739060|SUPERIORITY_OR_OTHER|||||||0.1992|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||0.1992
74094110|NCT00513682|147739068|SUPERIORITY_OR_OTHER|||||||0.0013||95.0|||||t-test, 1 sided|||||||0.0013
74094111|NCT00513682|147739069|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||t-test, 1 sided|||||||0.0009
74094112|NCT02450526|147739070|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|94.3|||<|0.0001|TWO_SIDED|95.0|90.8|97.7||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||97.7|90.8|<0.0001
74094113|NCT02450526|147739071|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|87.5|||<|0.0001|TWO_SIDED|95.0|82.5|92.4||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||92.4|82.5|<0.0001
74094114|NCT02450526|147739072|NON_INFERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment Difference|-2.4|||||TWO_SIDED|95.0|-6.7|1.9||||||The non-inferiority of Dysport® to Botox on the ILA at maximum frown was tested using a multivariate logistic regression model||1.9|-6.7|
74012574|NCT02187172|147575652|SUPERIORITY||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|14.11||0.8883|TWO_SIDED|95.0|-30.58|26.59|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||26.59|-30.58|0.8883
74012575|NCT02187172|147575653|SUPERIORITY||Mean Difference (Final Values)|-3027.21|STANDARD_ERROR_OF_MEAN|3180.58||0.3472|TWO_SIDED|95.0|-9465.95|3411.54|||Regression, Linear|||Comparison during RCT period||3411.54|-9465.95|0.3472
74012576|NCT02187172|147575653|SUPERIORITY||Mean Difference (Final Values)|-1974.63|STANDARD_ERROR_OF_MEAN|1659.11||0.2416|TWO_SIDED|95.0|-5336.3|1387.04|||Regression, Linear|||Combined ustekinumab and placebo groups for active treatment period analysis.||1387.04|-5336.30|0.2416
74012577|NCT02187172|147575654|SUPERIORITY||Mean Difference (Final Values)|20.66|STANDARD_ERROR_OF_MEAN|24.75||0.6742|TWO_SIDED|95.0|-78.03|119.34|||Regression, Linear|||Comparison during RCT period||119.34|-78.03|0.6742
74012578|NCT02187172|147575654|SUPERIORITY||Mean Difference (Final Values)|47.0|STANDARD_ERROR_OF_MEAN|35.84||0.1979|TWO_SIDED|95.0|-25.63|11963.0|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||11963|-25.63|0.1979
74012579|NCT02187172|147575655|SUPERIORITY||Mean Difference (Final Values)|-7884.29|STANDARD_ERROR_OF_MEAN|7780.29||0.3173|TWO_SIDED|95.0|-23634.67|7566.1|||Regression, Linear|||Comparison during RCT period||7566.10|-23634.67|0.3173
74012580|NCT02187172|147575655|SUPERIORITY||Mean Difference (Final Values)|-3782.54|STANDARD_ERROR_OF_MEAN|4073.25||0.3591|TWO_SIDED|95.0|-12035.72|4470.64|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||4470.64|-12035.72|0.3591
74012581|NCT02187172|147575656|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.54||0.9767|TWO_SIDED|95.0|-5.22|5.07|||Regression, Linear|||Comparison during RCT period||5.07|-5.22|0.9767
74012582|NCT02187172|147575656|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.09||0.3205|TWO_SIDED|95.0|-3.29|1.11|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.11|-3.29|0.3205
74094115|NCT02450526|147739073|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|73.8|||<|0.0001|TWO_SIDED|95.0|59.1|88.4|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||88.4|59.1|<0.0001
74012583|NCT02187172|147575657|SUPERIORITY||Mean Difference (Final Values)|-14.79|STANDARD_ERROR_OF_MEAN|19.96||0.4632|TWO_SIDED|95.0|-55.19|25.61|||Regression, Linear|||Comparison during RCT period||25.61|-55.19|0.4632
74012584|NCT02187172|147575657|SUPERIORITY||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|11.47||0.5316|TWO_SIDED|95.0|-30.47|15.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||15.99|-30.47|0.5316
74012585|NCT02187172|147575658|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.68||0.1928|TWO_SIDED|95.0|-2.27|0.47|||Regression, Linear|||Comparison during RCT period||0.47|-2.27|0.1928
74012586|NCT02187172|147575658|SUPERIORITY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.34||0.058|TWO_SIDED|95.0|-1.36|0.02|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.02|-1.36|0.0580
74012587|NCT02187172|147575659|SUPERIORITY||Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|11.41||0.7185|TWO_SIDED|95.0|-27.24|18.96|||Regression, Linear|||Comparison during RCT period||18.96|-27.24|0.7185
74012588|NCT02187172|147575659|SUPERIORITY||Mean Difference (Final Values)|-8.35|STANDARD_ERROR_OF_MEAN|8.41||0.3271|TWO_SIDED|95.0|-25.4|8.69|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||8.69|-25.40|0.3271
74012589|NCT02187172|147575660|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.51||0.3124|TWO_SIDED|95.0|-1.56|0.51|||Regression, Linear|||Comparison during RCT period||0.51|-1.56|0.3124
74012590|NCT02187172|147575660|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.11||0.0106|TWO_SIDED|95.0|-0.54|-0.08|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-0.08|-0.54|0.0106
74012591|NCT02187172|147575661|SUPERIORITY||Mean Difference (Final Values)|-70.76|STANDARD_ERROR_OF_MEAN|33.42||0.0408|TWO_SIDED|95.0|-138.42|-3.11|||Regression, Linear|||Comparison during RCT period||-3.11|-138.42|0.0408
74012592|NCT02187172|147575661|SUPERIORITY||Mean Difference (Final Values)|71.72|STANDARD_ERROR_OF_MEAN|132.87||0.5926|TWO_SIDED|95.0|-197.5|340.93|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||340.93|-197.50|0.5926
74012593|NCT02187172|147575662|SUPERIORITY||Mean Difference (Final Values)|191.49|STANDARD_ERROR_OF_MEAN|46.1||0.0002|TWO_SIDED|95.0|98.18|284.81|||Regression, Linear|||Comparison during RCT period||284.81|98.18|0.0002
74012594|NCT02187172|147575662|SUPERIORITY||Mean Difference (Final Values)|171.21|STANDARD_ERROR_OF_MEAN|20.3|<|0.0001|TWO_SIDED|95.0|130.08|212.34|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||212.34|130.08|<0.0001
74012595|NCT02187172|147575663|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.98||0.011|TWO_SIDED|95.0|-4.62|-0.64|||Regression, Linear|||Comparison during RCT period||-0.64|-4.62|0.0110
74012596|NCT02187172|147575663|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.32||0.0008|TWO_SIDED|95.0|-1.79|-0.51|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-0.51|-1.79|0.0008
74012597|NCT02187172|147575664|SUPERIORITY||Mean Difference (Final Values)|-155.31|STANDARD_ERROR_OF_MEAN|688.28||0.8227|TWO_SIDED|95.0|-1548.66|1238.04|||Regression, Linear|||Comparison during RCT period||1238.04|-1548.66|0.8227
74012598|NCT02187172|147575664|SUPERIORITY||Mean Difference (Final Values)|-407.43|STANDARD_ERROR_OF_MEAN|180.7||0.0302|TWO_SIDED|95.0|-773.57|-41.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-41.29|-773.57|0.0302
74012599|NCT02187172|147575665|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|-0.47||0.2333|TWO_SIDED|95.0|-1.25|0.32|||Regression, Linear|||Comparison during RCT period||0.32|-1.25|0.2333
74012600|NCT02187172|147575665|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.0713|TWO_SIDED|95.0|-0.8|0.03|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.03|-0.80|0.0713
74012601|NCT02187172|147575666|SUPERIORITY||Mean Difference (Final Values)|-16.87|STANDARD_ERROR_OF_MEAN|15.62||0.2869|TWO_SIDED|95.0|-48.48|14.75|||Regression, Linear|||Comparison during RCT period||14.75|-48.48|0.2869
74094116|NCT02450526|147739074|SUPERIORITY|The comparison between mean scores of SGA at Treatment Cycle 1, Day 29 is based on 2 separate linear mixed models, adjusting on the two stratification parameters, gender and baseline ILA severity score, and the centre.|Treatment Difference|2.603|||<|0.0001|TWO_SIDED|95.0|2.327|2.878||The test was two-sided at the significance level of 0.05|Mixed Models Analysis|||Superiority analysis of Dysport® to placebo was tested using a linear mixed model.||2.878|2.327|<0.0001
74012602|NCT02187172|147575666|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|1.71||0.1988|TWO_SIDED|95.0|-5.69|1.22|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.22|-5.69|0.1988
74094117|NCT02450526|147739075|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|83.7|||<|0.0001|TWO_SIDED|95.0|78.7|88.7|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||88.7|78.7|<0.0001
74094118|NCT01565616|147739099|OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|10.4||0.52|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the anxiety domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.52
74012603|NCT02187172|147575667|SUPERIORITY||Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|12.91||0.8744|TWO_SIDED|95.0|-24.09|28.2|||Regression, Linear|||Comparison during RCT period||28.20|-24.09|0.8744
74012604|NCT02187172|147575667|SUPERIORITY||Mean Difference (Final Values)|10.55|STANDARD_ERROR_OF_MEAN|8.26||0.2093|TWO_SIDED|95.0|-6.18|27.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||27.29|-6.18|0.2093
74012605|NCT02187172|147575668|SUPERIORITY||Mean Difference (Final Values)|19.2|STANDARD_ERROR_OF_MEAN|7.41||0.0135|TWO_SIDED|95.0|4.21|34.2|||Regression, Linear|||Comparison during RCT period||34.20|4.21|0.0135
74012606|NCT02187172|147575668|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|4.14||0.8499|TWO_SIDED|95.0|-9.19|7.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||7.61|-9.19|0.8499
74012607|NCT02187172|147575669|SUPERIORITY||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.96||0.0693|TWO_SIDED|95.0|-0.3|7.62|||Regression, Linear|||Comparison during RCT period||7.62|-0.30|0.0693
74012608|NCT02187172|147575669|SUPERIORITY||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.42||0.1841|TWO_SIDED|95.0|-0.96|4.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||4.80|-0.96|0.1841
74012609|NCT02187172|147575670|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|1.03||0.2305|TWO_SIDED|95.0|-0.83|3.34|||Regression, Linear|||Comparison during RCT period||3.34|-0.83|0.2305
74012610|NCT02187172|147575670|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.72||0.2189|TWO_SIDED|95.0|-0.53|2.37|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||2.37|-0.53|0.2189
74012611|NCT02187172|147575671|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.11||0.3212|TWO_SIDED|95.0|-0.34|0.11|||Regression, Linear|||Comparison during RCT period||0.11|-0.34|0.3212
74012612|NCT02187172|147575671|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0137|TWO_SIDED|95.0|0.04|0.31|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.31|0.04|0.0137
74012613|NCT02187172|147575672|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.6||0.8383|TWO_SIDED|95.0|-1.09|1.33|||Regression, Linear|||Comparison during RCT period||1.33|-1.09|0.8383
74012614|NCT02187172|147575672|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.36||0.1651|TWO_SIDED|95.0|-0.22|1.24|||Regression, Logistic|||Global change from baseline after 52 weeks of active treatment.||1.24|-0.22|0.1651
74012615|NCT02187172|147575673|SUPERIORITY||Mean Difference (Final Values)|2.49|STANDARD_ERROR_OF_MEAN|1.7||0.1502|TWO_SIDED|95.0|-0.94|5.93|||Regression, Linear|||Comparison during RCT period||5.93|-0.94|0.1502
74012616|NCT02187172|147575673|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.84||0.8054|TWO_SIDED|95.0|-1.49|1.91|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.91|-1.49|0.8054
74012617|NCT02187172|147575674|SUPERIORITY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.69||0.4235|TWO_SIDED|95.0|-4.79|2.05|||Regression, Linear|||Comparison during RCT period||2.05|-4.79|0.4235
74012618|NCT02187172|147575674|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.97||0.8653|TWO_SIDED|95.0|-1.8|2.13|||Regression, Linear|||Comparison during RCT period||2.13|-1.80|0.8653
74012619|NCT02187172|147575675|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.89||0.558|TWO_SIDED|95.0|-4.95|2.71|||Regression, Linear|||Comparison during RCT period||2.71|-4.95|0.5580
74012620|NCT02187172|147575675|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.0||0.4454|TWO_SIDED|95.0|-1.25|2.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||2.80|-1.25|0.4454
74012621|NCT02187172|147575676|SUPERIORITY||Mean Difference (Final Values)|21.37|STANDARD_ERROR_OF_MEAN|6.67||0.0027|TWO_SIDED|95.0|7.86|34.87|||Regression, Linear|||Comparison during RCT period||34.87|7.86|0.0027
74012622|NCT02187172|147575676|SUPERIORITY||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|4.07||0.4775|TWO_SIDED|95.0|-11.17|5.33|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||5.33|-11.17|0.4775
74012623|NCT02187172|147575677|SUPERIORITY||Mean Difference (Final Values)|230.77|STANDARD_ERROR_OF_MEAN|69.8||0.0021|TWO_SIDED|95.0|89.47|372.08|||Regression, Linear|||Comparison during RCT period||372.08|89.47|0.0021
74012624|NCT02187172|147575677|SUPERIORITY||Mean Difference (Final Values)|-31.89|STANDARD_ERROR_OF_MEAN|41.71||0.4493|TWO_SIDED|95.0|-116.4|52.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||52.61|-116.40|0.4493
74094119|NCT01565616|147739099|OTHER||Mean Difference (Net)|2.7|STANDARD_DEVIATION|6.4||0.12|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the depression domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.12
74094120|NCT01565616|147739099|OTHER||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|8.5||0.54|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the fatigue domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.54
74094121|NCT01565616|147739099|OTHER||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|9.3||0.006|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the pain interference domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.006
74094122|NCT01565616|147739099|OTHER||Mean Difference (Net)|5.8|STANDARD_DEVIATION|10.5||0.044|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the physical function domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.044
74094123|NCT01565616|147739099|OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|11.8||0.85|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the satisfaction with social role domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.85
74094124|NCT01565616|147739099|OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|13.5||0.88|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the sleep disturbances domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.88
74012625|NCT02187172|147575678|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.8008|TWO_SIDED|95.0|-0.3|0.38|||Regression, Linear|||Comparison during RCT period||0.38|-0.30|0.8008
74094125|NCT01565616|147739099|OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.1||0.53|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in raw scores of the pain intensity domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.53
74012626|NCT02187172|147575678|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.11||0.8068|TWO_SIDED|95.0|-0.19|0.24|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.24|-0.19|0.8068
74012627|NCT02187172|147575679|SUPERIORITY||Mean Difference (Final Values)|46.96|STANDARD_ERROR_OF_MEAN|56.12||0.4079|TWO_SIDED|95.0|-66.65|160.57|||Regression, Logistic|||Comparison during RCT period||160.57|-66.65|0.4079
74012628|NCT02187172|147575679|SUPERIORITY||Mean Difference (Final Values)|4.68|STANDARD_ERROR_OF_MEAN|33.85||0.8907|TWO_SIDED|95.0|-63.91|73.28|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||73.28|-63.91|0.8907
74012629|NCT02187172|147575680|SUPERIORITY||Mean Difference (Final Values)|7.01|STANDARD_ERROR_OF_MEAN|48.81||0.8866|TWO_SIDED|95.0|-91.8|105.81|||Regression, Linear|||Comparison during RCT period||105.81|-91.80|0.8866
74012630|NCT02187172|147575680|SUPERIORITY||Mean Difference (Final Values)|-24.74|STANDARD_ERROR_OF_MEAN|32.59||0.4527|TWO_SIDED|95.0|-90.78|41.3|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||41.30|-90.78|0.4527
74012631|NCT02187172|147575681|SUPERIORITY||Mean Difference (Final Values)|194.69|STANDARD_ERROR_OF_MEAN|66.23||0.0056|TWO_SIDED|95.0|60.61|328.77|||Regression, Linear|||Comparison during RCT period||328.77|60.61|0.0056
74012632|NCT02187172|147575681|SUPERIORITY||Mean Difference (Final Values)|-29.16|STANDARD_ERROR_OF_MEAN|38.01||0.4478|TWO_SIDED|95.0|-106.17|47.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||47.85|-106.17|0.4478
74012633|NCT02187172|147575682|SUPERIORITY||Mean Difference (Final Values)|3.14|STANDARD_ERROR_OF_MEAN|2.81||0.2704|TWO_SIDED|95.0|-2.55|8.83|||Regression, Linear|||Comparison during RCT period||8.83|-2.55|0.2704
74012634|NCT02187172|147575682|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|1.41||0.295|TWO_SIDED|95.0|-1.36|4.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||4.36|-1.36|0.2950
74012635|NCT02187172|147575683|SUPERIORITY||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|6.57||0.0149|TWO_SIDED|95.0|-30.03|-3.45|||Regression, Linear|||Comparison during RCT period||-3.45|-30.03|0.0149
74012636|NCT02187172|147575683|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|3.37||0.9734|TWO_SIDED|95.0|-6.93|6.71|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||6.71|-6.93|0.9734
74094126|NCT01150890|147739211|SUPERIORITY|||||||0.1941|||||||Overall Trend test|||The primary null hypothesis was tested sequentially using a linear trend test at the significance level of 0.05 (two-sided) using logistic regression modeling.||||0.1941
74012637|NCT02187172|147575684|SUPERIORITY||Mean Difference (Net)|-9.21|STANDARD_ERROR_OF_MEAN|11.76||0.4384|TWO_SIDED|95.0|-33.03|14.6|||Regression, Linear|||Comparison during RCT period||14.60|-33.03|0.4384
74094127|NCT01150890|147739211|SUPERIORITY||Difference in Response Rate|0.0||||1|TWO_SIDED|95.0|-0.09|0.09|||Chi-squared|||||0.09|-0.09|1.0000
74094128|NCT01150890|147739211|SUPERIORITY||Difference in Response Rate|0.1203||||0.0966|TWO_SIDED|95.0|-0.02|0.26|||Chi-squared|||||0.26|-0.02|0.0966
74094129|NCT01150890|147739211|SUPERIORITY||Difference in Response Rate|0.0597||||0.3208|TWO_SIDED|95.0|-0.06|0.17|||Chi-squared|||||0.17|-0.06|0.3208
74094130|NCT01150890|147739212|SUPERIORITY||Difference in Response Rate|0.0363||||0.6831|TWO_SIDED|95.0|-0.14|0.21|||Chi-squared|||||0.21|-0.14|0.6831
74094131|NCT01150890|147739212|SUPERIORITY||Difference in Response Rate|0.1477||||0.1396|TWO_SIDED|95.0|-0.04|0.34|||Chi-squared|||||0.34|-0.04|0.1396
74094132|NCT01150890|147739212|SUPERIORITY||Difference in Response Rate|0.0265||||0.7588|TWO_SIDED|95.0|-0.14|0.19|||Chi-squared|||||0.19|-0.14|0.7588
74094133|NCT01150890|147739213|SUPERIORITY|||||||0.4161|||||||ANCOVA|Analysis of covariance (ANCOVA) model adjusted for baseline CDAI score.||||||0.4161
74094134|NCT01150890|147739213|SUPERIORITY|||||||0.8094|||||||ANCOVA|ANCOVA model adjusted for baseline CDAI score.||||||0.8094
74094135|NCT01150890|147739213|SUPERIORITY|||||||0.304|||||||ANCOVA|ANCOVA model adjusted for baseline CDAI score.||||||0.3040
74094136|NCT00922987|147739220|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||||||<0.0001
74094137|NCT00446199|147739228|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094138|NCT00446199|147739228|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094139|NCT00446199|147739228|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0005
74094140|NCT00446199|147739229|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/ van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094141|NCT00446199|147739229|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094142|NCT00446199|147739229|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094143|NCT00446199|147739230|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094144|NCT00446199|147739230|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094145|NCT00446199|147739230|SUPERIORITY_OR_OTHER|||||||0.0096||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0096
74094146|NCT00446199|147739231|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094147|NCT00446199|147739231|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094148|NCT00446199|147739231|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0005
74094149|NCT00446199|147739232|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74042586|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|804.703|||||TWO_SIDED|95.0|803.017|806.38|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||806.380|803.017|
74042587|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|818.66|||||TWO_SIDED|95.0|816.391|820.912|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||820.912|816.391|
74042588|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|916.079|||||TWO_SIDED|95.0|914.891|917.256|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||917.256|914.891|
74042589|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|928.568|||||TWO_SIDED|95.0|927.038|930.076|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||930.076|927.038|
74042590|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|796.894||||||95.0|795.175|798.605|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||798.605|795.175|
74042591|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|803.918|||||TWO_SIDED|95.0|801.571|806.25|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||806.250|801.571|
74094150|NCT00446199|147739232|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094151|NCT00446199|147739232|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3 mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094152|NCT00446199|147739233|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74012638|NCT02187172|147575684|SUPERIORITY||Mean Difference (Final Values)|11.14|STANDARD_ERROR_OF_MEAN|7.33||0.1373|TWO_SIDED|95.0|-3.72|25.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||25.99|-3.72|0.1373
74012639|NCT02187172|147575685|SUPERIORITY||Mean Difference (Final Values)|-15.71|STANDARD_ERROR_OF_MEAN|5.77||0.0097|TWO_SIDED|95.0|-27.39|-4.03|||Regression, Linear|||Comparison during RCT period||-4.03|-27.39|0.0097
74012640|NCT02187172|147575685|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.07||0.8119|TWO_SIDED|95.0|-4.69|3.7|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||3.70|-4.69|0.8119
74012641|NCT02187172|147575686|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|4.57||0.9415|TWO_SIDED|95.0|-8.91|9.59|||Regression, Linear|||Comparison during RCT period||9.59|-8.91|0.9415
74012642|NCT02187172|147575686|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|2.43||0.4485|TWO_SIDED|95.0|-6.77|3.06|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||3.06|-6.77|0.4485
74012643|NCT02187172|147575687|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|5.16||0.988|TWO_SIDED|95.0|-10.37|10.53|||Regression, Linear|||Comparison during RCT period||10.53|-10.37|0.9880
74012644|NCT02187172|147575687|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|2.59||0.8836|TWO_SIDED|95.0|-4.86|5.63|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||5.63|-4.86|0.8836
74012645|NCT02187172|147575688|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.3||0.8321|TWO_SIDED|95.0|-2.91|2.36|||Regression, Linear|||Comparison during RCT period||2.36|-2.91|0.8321
74012646|NCT02187172|147575688|SUPERIORITY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.08||0.0394|TWO_SIDED|95.0|0.12|4.48|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||4.48|0.12|0.0394
74012647|NCT02187172|147575689|SUPERIORITY||Mean Difference (Final Values)|152.68|STANDARD_ERROR_OF_MEAN|43.76||0.0012|TWO_SIDED|95.0|64.07|241.23|||Regression, Linear|||Comparison during RCT period||241.23|64.07|0.0012
74012648|NCT02187172|147575689|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|25.7||0.9085|TWO_SIDED|95.0|-55.04|49.09|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||49.09|-55.04|0.9085
74012649|NCT02187172|147575690|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.1792|TWO_SIDED|95.0|-0.03|0.14|||Regression, Linear|||Comparison during RCT period||0.14|-0.03|0.1792
74012650|NCT02187172|147575690|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2559|TWO_SIDED|95.0|-0.03|0.1|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||0.10|-0.03|0.2559
74012651|NCT02187172|147575691|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2453|TWO_SIDED|95.0|-0.11|0.41|||Regression, Linear|||||0.41|-0.11|0.2453
74012652|NCT02187172|147575691|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.1087|TWO_SIDED|95.0|-0.02|0.23|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||0.23|-0.02|0.1087
74012653|NCT02187172|147575692|SUPERIORITY||Mean Difference (Final Values)|48.43|STANDARD_ERROR_OF_MEAN|61.62||0.4368|TWO_SIDED|95.0|-76.31|173.16|||Regression, Linear|||Comparison during RCT period||173.16|-76.31|0.4368
74012654|NCT02187172|147575692|SUPERIORITY||Mean Difference (Final Values)|-49.56|STANDARD_ERROR_OF_MEAN|27.84||0.0833|TWO_SIDED|95.0|-105.97|6.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||6.85|-105.97|0.0833
74012655|NCT02187172|147575693|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.11||0.8036|TWO_SIDED|95.0|-2.52|1.97|||Regression, Linear|||Comparison during RCT period||1.97|-2.52|0.8036
74012656|NCT02187172|147575693|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.51||0.4608|TWO_SIDED|95.0|-0.65|1.4|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||1.40|-0.65|0.4608
74012657|NCT02187172|147575694|SUPERIORITY||Mean Difference (Final Values)|3320.58|STANDARD_ERROR_OF_MEAN|3414.9||0.337|TWO_SIDED|95.0|-3592.52|10233.67|||Regression, Linear|||Comparison during RCT period||10233.67|-3592.52|0.3370
74012658|NCT02187172|147575694|SUPERIORITY||Mean Difference (Final Values)|6926.25|STANDARD_ERROR_OF_MEAN|2257.84||0.004|TWO_SIDED|95.0|2351.43|11501.07|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||11501.07|2351.43|0.0040
74012659|NCT02187172|147575695|SUPERIORITY||Mean Difference (Final Values)|-68.95|STANDARD_ERROR_OF_MEAN|131.9||0.6042|TWO_SIDED|95.0|-335.97|198.08|||Regression, Linear|||Comparison during RCT period||198.08|-335.97|0.6042
74012660|NCT02187172|147575695|SUPERIORITY||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|85.98||0.9267|TWO_SIDED|95.0|-182.18|166.26|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||166.26|-182.18|0.9267
74012661|NCT02187172|147575696|SUPERIORITY||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|5.18||0.4226|TWO_SIDED|95.0|-6.28|14.68|||Regression, Linear|||Comparison during RCT period||14.68|-6.28|0.4226
74012662|NCT02187172|147575696|SUPERIORITY||Mean Difference (Final Values)|3.41|STANDARD_ERROR_OF_MEAN|3.43||0.327|TWO_SIDED|95.0|-3.54|10.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||10.36|-3.54|0.3270
74012663|NCT02187172|147575697|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.52||0.7507|TWO_SIDED|95.0|-3.56|2.59|||Regression, Linear|||Comparison during RCT period||2.59|-3.56|0.7507
74012664|NCT02187172|147575697|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.89||0.9348|TWO_SIDED|95.0|-1.88|1.73|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||1.73|-1.88|0.9348
74012665|NCT02187172|147575698|SUPERIORITY||Difference of proportions|0.67||||0.0005|TWO_SIDED|95.0|0.45|0.89|||Chi-squared|||||0.89|0.45|0.0005
74012666|NCT02187172|147575698|OTHER|95% CI of proportion achieving PASI75 at end of study|Proportion|0.72|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
74012667|NCT02187172|147575699|SUPERIORITY||Difference of proportions|0.41||||0.0016|TWO_SIDED|95.0|0.2|0.62|||Chi-squared|||||0.62|0.20|0.0016
74012668|NCT02187172|147575699|OTHER|95% CI of proportion achieving PASI90 at end of study|Proportion|0.49|||||TWO_SIDED|95.0|0.32|0.65||||||||0.65|0.32|
74012669|NCT02187172|147575700|SUPERIORITY||Difference of proportions|0.53||||0.0005|TWO_SIDED|95.0|0.29|0.78|||Chi-squared|||Comparison during RCT period for binary Physician Global Assessment||0.78|0.29|0.0005
73879793|NCT03192176|147297616|SUPERIORITY||LSMean difference|25.6|STANDARD_ERROR_OF_MEAN|7.54||0.0008|TWO_SIDED|95.0|10.77|40.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||40.43|10.77|0.0008
73879794|NCT03192176|147297616|SUPERIORITY||LSMean difference|31.3|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.75|45.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||45.94|16.75|<0.0001
73879795|NCT03192176|147297616|SUPERIORITY||LSMean difference|29.4|STANDARD_ERROR_OF_MEAN|7.39|<|0.0001|TWO_SIDED|95.0|14.91|43.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||43.97|14.91|<0.0001
73879796|NCT03192176|147297616|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|7.05||0.0045|TWO_SIDED|95.0|6.31|34.06||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||34.06|6.31|0.0045
73879797|NCT03192176|147297616|SUPERIORITY||LSMean difference|30.6|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|16.68|44.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||44.49|16.68|<0.0001
73879798|NCT03192176|147297616|SUPERIORITY||LSMean difference|29.1|STANDARD_ERROR_OF_MEAN|7.08|<|0.0001|TWO_SIDED|95.0|15.14|42.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||42.98|15.14|<0.0001
74094153|NCT00446199|147739233|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
73879799|NCT03192176|147297616|SUPERIORITY||LSMean difference|40.1|STANDARD_ERROR_OF_MEAN|7.19|<|0.0001|TWO_SIDED|95.0|25.96|54.26||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||54.26|25.96|<0.0001
74094154|NCT00446199|147739233|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
74094155|NCT00446199|147739234|SUPERIORITY_OR_OTHER|||||||0.0314||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0314
74094156|NCT00446199|147739234|SUPERIORITY_OR_OTHER|||||||0.878||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8780
74012670|NCT02187172|147575700|OTHER|95% CI of proportion achieving PGA clear/almost clear at end of study|Proportion|0.46|||||TWO_SIDED|95.0|0.3|0.63||||||||0.63|0.30|
74012671|NCT02187172|147575701|SUPERIORITY||Mean Difference (Final Values)|8.32|STANDARD_ERROR_OF_MEAN|6.3||0.1944|TWO_SIDED|95.0|-4.42|21.06|||Regression, Linear|||||21.06|-4.42|0.1944
74094157|NCT00446199|147739234|SUPERIORITY_OR_OTHER|||||||0.5908||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.5908
74094158|NCT00446199|147739235|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0027
74094159|NCT00446199|147739235|SUPERIORITY_OR_OTHER|||||||0.4463||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4463
74094160|NCT00446199|147739235|SUPERIORITY_OR_OTHER|||||||0.0303||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0303
74094161|NCT00446199|147739236|SUPERIORITY_OR_OTHER|||||||0.4397||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4397
74094162|NCT00446199|147739236|SUPERIORITY_OR_OTHER|||||||0.0132||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0132
74094163|NCT00446199|147739236|SUPERIORITY_OR_OTHER|||||||0.325||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.3250
74094164|NCT00446199|147739237|SUPERIORITY_OR_OTHER|||||||0.9555||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.9555
74094165|NCT00446199|147739237|SUPERIORITY_OR_OTHER|||||||0.1743||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.1743
74094166|NCT00446199|147739237|SUPERIORITY_OR_OTHER|||||||0.4395||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4395
74094167|NCT00446199|147739238|SUPERIORITY_OR_OTHER|||||||0.8966||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8966
74094168|NCT00446199|147739238|SUPERIORITY_OR_OTHER|||||||0.7512||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.7512
73879800|NCT03192176|147297616|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|7.15||0.0007|TWO_SIDED|95.0|10.28|38.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||38.42|10.28|0.0007
73888007|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|35.7||||0.0335|TWO_SIDED|95.0|2.8|68.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||68.5|2.8|0.0335
74042592|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|865.679|||||TWO_SIDED|95.0|864.227|867.121|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||867.121|864.227|
74094169|NCT00446199|147739238|SUPERIORITY_OR_OTHER|||||||0.8751||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8751
74094170|NCT00446199|147739239|SUPERIORITY_OR_OTHER|||||||0.1067||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.1067
74094171|NCT00446199|147739239|SUPERIORITY_OR_OTHER|||||||0.6011||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.6011
74094172|NCT00446199|147739239|SUPERIORITY_OR_OTHER|||||||0.4408||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.4408
74094173|NCT00446199|147739240|SUPERIORITY_OR_OTHER|||||||0.0144||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.0144
74094174|NCT00446199|147739240|SUPERIORITY_OR_OTHER|||||||0.5589||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.5589
74094175|NCT00446199|147739240|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.5500
74094176|NCT00446199|147739241|SUPERIORITY_OR_OTHER|||||||0.2179||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.2179
74094177|NCT00446199|147739241|SUPERIORITY_OR_OTHER|||||||0.7749||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.7749
74094178|NCT00446199|147739241|SUPERIORITY_OR_OTHER|||||||0.8307||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.8307
74094179|NCT00446199|147739242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.6|||<|0.0001||95.0|-33.2|-22.0||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-22.0|-33.2|<0.0001
74094180|NCT00446199|147739242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|||<|0.0001||95.0|-27.8|-16.6||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-16.6|-27.8|<0.0001
74094181|NCT00446199|147739242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8||||0.0007||95.0|-15.4|-4.2||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline||-4.2|-15.4|0.0007
74094182|NCT00446199|147739243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|||<|0.0001||95.0|-29.9|17.8||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||17.8|-29.9|<0.0001
74094183|NCT00446199|147739243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|||<|0.0001||95.0|-20.2|-8.1||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-8.1|-20.2|<0.0001
73879801|NCT03192176|147297616|SUPERIORITY||LSMean difference|26.7|STANDARD_ERROR_OF_MEAN|7.06||0.0002|TWO_SIDED|95.0|1.78|40.55||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||40.55|1.78|0.0002
74094184|NCT00446199|147739243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.0054||95.0|-14.6|-2.5||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-2.5|-14.6|0.0054
74094185|NCT00446199|147739244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.069|||<|0.0001||95.0|-1.28|-0.859||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.859|-1.280|<0.0001
74094186|NCT00446199|147739244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.803|||<|0.0001||95.0|-1.013|-0.593||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.593|-1.013|<0.0001
74094187|NCT00446199|147739244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.361||||0.0007||95.0|-0.57|-0.152||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.152|-0.570|0.0007
74094188|NCT00446199|147739245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.635|||<|0.0001||95.0|-0.813|-0.458||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.458|-0.813|<0.0001
74094189|NCT00446199|147739245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.382|||<|0.0001||95.0|-0.56|-0.205||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.205|-0.560|<0.0001
74094190|NCT00446199|147739245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.204||||0.0233||95.0|-0.381|-0.028||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between E2 (0.3) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.028|-0.381|0.0233
74094191|NCT01822574|147739246|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||0.001
73888008|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|30.8||||0.0661|TWO_SIDED|95.0|-2.1|63.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||63.6|-2.1|0.0661
74094192|NCT01822574|147739247|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||<0.001
74094193|NCT01822574|147739248|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||0.240
74094194|NCT01951885|147739266|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|47 patients per arm were needed to detect a 25% improvement in mucositis based on a one-sided test with 5% significance and 80% power.||||||0.05
74094195|NCT01951885|147739269|NON_INFERIORITY|Cumulative incidence methods are compared using the Gray test with a p-value \<0.05|||||<|0.05|||||||Log Rank|||||||<0.05
74094196|NCT01951885|147739270|NON_INFERIORITY|Hospital stay will be compared between groups using the Wilcoxon rank sum test with a p value of 0.05.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
74094197|NCT01951885|147739271|NON_INFERIORITY|TPN use will be compared using the Chi-square test.|||||<|0.05|||||||Chi-squared|||||||<0.05
74094198|NCT01951885|147739272|NON_INFERIORITY|Overall survival was estimated using the Kaplan-Meier method and compared between patients receiving Tac/MTX versus Tac/mini-MTX/MMF using the log-rank test|||||<|0.05|||||||Log Rank|||||||<0.05
74094199|NCT01951885|147739273|NON_INFERIORITY|Progression-free survival was estimated using the Kaplan-Meier method and compared between patients receiving Tac/MTX versus Tac/mini-MTX/MMF using the log-rank test|||||<|0.05|||||||Log Rank|||||||<0.05
74094200|NCT01951885|147739276|NON_INFERIORITY|Infusion times will be compared using the Wilcoxon rank sum test|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74094201|NCT01951885|147739277|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
74094202|NCT01951885|147739278|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
73879802|NCT03192176|147297616|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|7.03||0.001|TWO_SIDED|95.0|9.55|37.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||37.22|9.55|0.0010
73879803|NCT03192176|147297616|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|6.6||0.004|TWO_SIDED|95.0|6.13|32.11||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||32.11|6.13|0.0040
74094203|NCT01951885|147739279|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Chi-squared|||||||<0.05
74094204|NCT01951885|147739280|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
73879804|NCT03192176|147297616|SUPERIORITY||LSMean difference|23.8|STANDARD_ERROR_OF_MEAN|6.62||0.0004|TWO_SIDED|95.0|10.8|36.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||36.83|10.80|0.0004
74042593|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|871.749|||||TWO_SIDED|95.0|869.771|873.707|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||873.707|869.771|
74042594|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|753.423|||||TWO_SIDED|95.0|751.591|755.249|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||755.249|751.591|
74094205|NCT01951885|147739282|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
74094206|NCT01951885|147739283|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
74094207|NCT01951885|147739284|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
74094208|NCT04709835|147739305|SUPERIORITY||Difference in Adjusted Means|-0.11|STANDARD_ERROR_OF_MEAN|0.292||0.7144|TWO_SIDED|80.0|-0.49|0.27|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 3||0.27|-0.49|0.7144
73879805|NCT03192176|147297616|SUPERIORITY||LSMean difference|27.2|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|14.1|40.24||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||40.24|14.10|<0.0001
74094209|NCT04709835|147739305|SUPERIORITY||Difference in Adjusted Means|0.32|STANDARD_ERROR_OF_MEAN|0.327||0.3373|TWO_SIDED|80.0|-0.11|0.74|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 5||0.74|-0.11|0.3373
74094210|NCT04709835|147739305|SUPERIORITY||Difference in Adjusted Means|-0.25|STANDARD_ERROR_OF_MEAN|0.315||0.426|TWO_SIDED|80.0|-0.66|0.16|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 7||0.16|-0.66|0.4260
74094211|NCT04709835|147739306|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|80.0|0.53|1.74|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||1.74|0.53|
74094212|NCT04709835|147739306|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|80.0|0.76|2.32|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||2.32|0.76|
74094213|NCT04709835|147739307|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|80.0|0.44|1.7|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||1.70|0.44|
73879806|NCT03192176|147297616|SUPERIORITY||LSMean difference|35.6|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|95.0|22.34|48.88||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||48.88|22.34|<0.0001
74042595|NCT00861380|147636918|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|755.542|||||TWO_SIDED|95.0|753.008|758.064|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||758.064|753.008|
74042596|NCT00637377|147636930|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.2|||||TWO_SIDED|95.0|-4.86|2.46|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q4).||2.46|-4.86|
74042597|NCT00637377|147636930|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.84|||||TWO_SIDED|95.0|-5.4|1.71|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 0.5mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 0.5mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 0.5mg Q4).||1.71|-5.40|
74042598|NCT00637377|147636930|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.13|||||TWO_SIDED|95.0|-4.81|2.55|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q8 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q8, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q8).||2.55|-4.81|
74042599|NCT00637377|147636931|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.9484||||0.076|TWO_SIDED|95.0|-4.1009|0.204||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||0.2040|-4.1009|0.076
74042600|NCT00637377|147636931|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.062||||0.9555|TWO_SIDED|95.0|-2.2398|2.1158||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||2.1158|-2.2398|0.9555
74042601|NCT00637377|147636931|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.9014||||0.4131|TWO_SIDED|95.0|-3.0615|1.2587||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||1.2587|-3.0615|0.4131
74012672|NCT02187172|147575701|SUPERIORITY||Mean Difference (Final Values)|-12.33|STANDARD_ERROR_OF_MEAN|3.5||0.0011|TWO_SIDED|95.0|-19.4|-5.25|||Regression, Linear|||||-5.25|-19.40|0.0011
74012673|NCT02187172|147575702|SUPERIORITY||Mean Difference (Final Values)|-779.59|STANDARD_ERROR_OF_MEAN|1049.99||0.4628|TWO_SIDED|95.0|-2911.19|1352.01|||Regression, Linear|||||1352.01|-2911.19|0.4628
74012674|NCT02187172|147575702|SUPERIORITY||Mean Difference (Final Values)|-910.84|STANDARD_ERROR_OF_MEAN|729.96||0.2209|TWO_SIDED|95.0|-2395.95|574.27|||Regression, Linear|||||574.27|-2395.95|0.2209
74012675|NCT00880399|147575703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.4295|TWO_SIDED|95.0|-1.65|0.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 1||0.70|-1.65|0.4295
74012676|NCT00880399|147575703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15||||0.0586|TWO_SIDED|95.0|-2.34|0.04|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 1||0.04|-2.34|0.0586
74094214|NCT04709835|147739307|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|80.0|0.56|2.03|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||2.03|0.56|
74094215|NCT04709835|147739308|SUPERIORITY||Difference in Percentage of Positivity|5.0|||||TWO_SIDED|80.0|-0.16|10.16|||||Confidence interval estimated with the Farrington-Manning method.|Day 3||10.16|-0.16|
74012677|NCT00880399|147575703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.0111|TWO_SIDED|95.0|-3.34|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 2||-0.43|-3.34|0.0111
74094216|NCT04709835|147739308|SUPERIORITY||Difference in Percentage of Positivity|-1.9|||||TWO_SIDED|80.0|-9.2|5.41|||||Confidence interval estimated with the Farrington-Manning method.|Day 3||5.41|-9.20|
74012678|NCT00880399|147575703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.84||||0.0141|TWO_SIDED|95.0|-3.3|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 2||-0.37|-3.30|0.0141
74012679|NCT00880399|147575703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22||||0.0152|TWO_SIDED|95.0|-4.0|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 4||-0.43|-4.00|0.0152
74012680|NCT00880399|147575703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.06||||0.001|TWO_SIDED|95.0|-4.86|-1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 4||-1.25|-4.86|0.0010
74012681|NCT00880399|147575703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.41||||0.0245|TWO_SIDED|95.0|-4.5|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 6||-0.31|-4.50|0.0245
74012682|NCT00880399|147575703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.86||||0.0082|TWO_SIDED|95.0|-4.97|-0.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 6||-0.75|-4.97|0.0082
74012683|NCT00880399|147575705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.51|TWO_SIDED|95.0|0.8|3.19|||Log Rank|||Placebo Vs Orvepitant 30 mg at Week 6||3.19|0.80|0.51
74012684|NCT00880399|147575705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.37|TWO_SIDED|95.0|0.84|3.3|||Log Rank|||Placebo Vs Orvepitant 60 mg at Week 6||3.30|0.84|0.37
74012685|NCT00880399|147575706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.7859|TWO_SIDED|95.0|-0.72|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.55|-0.72|0.7859
74012686|NCT00880399|147575706|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.15||||0.6429|TWO_SIDED|95.0|-0.79|0.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.49|-0.79|0.6429
74012687|NCT00880399|147575706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04||||0.0092|TWO_SIDED|95.0|-1.82|-0.26|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||-0.26|-1.82|0.0092
74012688|NCT00880399|147575706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91||||0.023|TWO_SIDED|95.0|-1.69|-0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||-0.13|-1.69|0.0230
74012689|NCT00880399|147575706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.0104|TWO_SIDED|95.0|-2.27|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.31|-2.27|0.0104
74012690|NCT00880399|147575706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.68||||0.001|TWO_SIDED|95.0|-2.67|-0.69|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.69|-2.67|0.0010
74012691|NCT00880399|147575706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.0361|TWO_SIDED|95.0|-2.37|-0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.08|-2.37|0.0361
74012692|NCT00880399|147575706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54||||0.0092||95.0|-2.69|-0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.38|-2.69|0.0092
74012693|NCT00880399|147575707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72||||0.1662|TWO_SIDED|95.0|-1.74|0.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.30|-1.74|0.1662
74012694|NCT00880399|147575707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.2116|TWO_SIDED|95.0|-1.69|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.38|-1.69|0.2116
74012695|NCT00880399|147575707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.02||||0.082|TWO_SIDED|95.0|-2.17|0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.13|-2.17|0.0820
74012696|NCT00880399|147575707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.3498|TWO_SIDED|95.0|-1.71|0.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.61|-1.71|0.3498
74012697|NCT00880399|147575707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.0107|TWO_SIDED|95.0|-2.99|-0.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.40|-2.99|0.0107
74012698|NCT00880399|147575707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.0017|TWO_SIDED|95.0|-3.4|-0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.79|-3.40|0.0017
74094217|NCT04709835|147739308|SUPERIORITY||Difference in Percentage of Positivity|5.79|||||TWO_SIDED|80.0|-4.82|16.4|||||Confidence interval estimated with the Farrington-Manning method.|Day 5||16.40|-4.82|
74094218|NCT04709835|147739308|SUPERIORITY||Difference in Percentage of Positivity|-0.88|||||TWO_SIDED|80.0|-12.4|10.65|||||Confidence interval estimated with the Farrington-Manning method.|Day 5||10.65|-12.40|
74094219|NCT04709835|147739308|SUPERIORITY||Difference in Percentage of Positivity|2.39|||||TWO_SIDED|80.0|-10.64|15.42|||||Confidence interval estimated with the Farrington-Manning method.|Day 7||15.42|-10.64|
74094220|NCT04709835|147739308|SUPERIORITY||Difference in Percentage of Positivity|-0.26|||||TWO_SIDED|80.0|-13.39|12.88|||||Confidence interval estimated with the Farrington-Manning method.|Day 7||12.88|-13.39|
74094221|NCT04709835|147739320|SUPERIORITY||Difference in Adjusted Means|-0.1|STANDARD_ERROR_OF_MEAN|0.294||0.7351|TWO_SIDED|80.0|-0.48|0.28|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 3||0.28|-0.48|0.7351
74094222|NCT04709835|147739320|SUPERIORITY||Difference in Adjusted Means|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7524|TWO_SIDED|80.0|-0.5|0.3|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 5||0.30|-0.50|0.7524
73879807|NCT03192176|147297616|SUPERIORITY||LSMean difference|20.0|STANDARD_ERROR_OF_MEAN|6.72||0.0032|TWO_SIDED|95.0|6.76|33.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||33.19|6.76|0.0032
74042602|NCT00637377|147636932|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.57||||0.229|TWO_SIDED|95.0|-12.02|2.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q4 group|The null hypothesis is that the two proportions are equal.||2.88|-12.02|0.229
74042603|NCT00637377|147636932|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.78||||0.843|TWO_SIDED|95.0|-6.91|8.46||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 0.5mg Q4 group|The null hypothesis is that the two proportions are equal.||8.46|-6.91|0.843
74042604|NCT00637377|147636932|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.65||||0.49|TWO_SIDED|95.0|-10.18|4.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The null hypothesis is that the two proportions are equal.||4.88|-10.18|0.490
74094223|NCT04709835|147739320|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.314||0.8083|TWO_SIDED|80.0|-0.48|0.33|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 7||0.33|-0.48|0.8083
74094224|NCT01462318|147739358|SUPERIORITY_OR_OTHER||ratio|1.015|||||TWO_SIDED|90.0|0.894|1.153|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.153|0.894|
74094225|NCT01462318|147739358|SUPERIORITY_OR_OTHER||ratio|1.005|||||TWO_SIDED|90.0|0.951|1.063|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.063|0.951|
74094226|NCT01462318|147739358|SUPERIORITY_OR_OTHER||ratio|0.996|||||TWO_SIDED|90.0|0.88|1.127|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.127|0.880|
74094227|NCT01462318|147739358|SUPERIORITY_OR_OTHER||ratio|1.032|||||TWO_SIDED|90.0|0.93|1.145|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (\>5% of maximum observed concentration \[Cmax\]).||1.145|0.930|
74094228|NCT01462318|147739359|SUPERIORITY_OR_OTHER||ratio|1.012|||||TWO_SIDED|90.0|0.764|1.342|||||test/reference = dextromethorphan+DAC HYP/dextromethorphan|Pairwise comparison: dextromethorphan. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.342|0.764|
74094229|NCT01462318|147739367|SUPERIORITY_OR_OTHER||ratio|1.079|||||TWO_SIDED|90.0|0.912|1.276|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.276|0.912|
74094230|NCT01462318|147739367|SUPERIORITY_OR_OTHER||ratio|1.012|||||TWO_SIDED|90.0|0.952|1.075|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.075|0.952|
74094231|NCT01462318|147739367|SUPERIORITY_OR_OTHER||ratio|1.058|||||TWO_SIDED|90.0|0.804|1.392|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.392|0.804|
74094232|NCT01462318|147739367|SUPERIORITY_OR_OTHER||ratio|1.116|||||TWO_SIDED|90.0|1.005|1.238|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (\>5% of Cmax).||1.238|1.005|
74094233|NCT01462318|147739369|SUPERIORITY_OR_OTHER||ratio|0.878|||||TWO_SIDED|90.0|0.697|1.105|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.105|0.697|
74094234|NCT00667810|147739381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.83||||0.057|TWO_SIDED|95.0|-3.71|0.05||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood (REML) based mixed model for repeated-measures (MMRM). The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||0.05|-3.71|0.057
74094235|NCT00667810|147739381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.848|TWO_SIDED|95.0|-1.73|2.1||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||2.10|-1.73|0.848
74094236|NCT00667810|147739382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.459|TWO_SIDED|95.0|-2.48|5.49||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||5.49|-2.48|0.459
73879808|NCT03192176|147297616|SUPERIORITY||LSMean difference|24.1|STANDARD_ERROR_OF_MEAN|6.64||0.0003|TWO_SIDED|95.0|11.02|37.13||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||37.13|11.02|0.0003
74042605|NCT00637377|147636933|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-2.7885||||0.0097|TWO_SIDED|95.0|-4.9012|-0.6757||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||-0.6757|-4.9012|0.0097
74042606|NCT00637377|147636933|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.932||||0.3917|TWO_SIDED|95.0|-3.0658|1.2019||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||1.2019|-3.0658|0.3917
74042607|NCT00637377|147636933|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.947||||0.0717|TWO_SIDED|95.0|-4.0659|0.1718||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||0.1718|-4.0659|0.0717
74042608|NCT00637377|147636934|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.18||||0.0038|TWO_SIDED|95.0|-1.979|-0.382||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||-0.382|-1.979|0.0038
74042609|NCT00637377|147636934|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.17||||0.6784|TWO_SIDED|95.0|-0.632|0.972||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||0.972|-0.632|0.6784
74042610|NCT00637377|147636934|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.733||||0.0727|TWO_SIDED|95.0|-1.534|0.068||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||0.068|-1.534|0.0727
74042611|NCT01062009|147636963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Chi-squared|||Chi square analysis comparing number of participants with new fever in each group||||0.24
74042612|NCT01468701|147636966|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.6|0.9|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.90|0.60|
74042613|NCT01468701|147636968|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.63|0.98|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.98|0.63|
74042614|NCT01468701|147636969|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.57|1.11|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.11|0.57|
74042615|NCT01468701|147636971|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.57|1.14|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.14|0.57|
73879809|NCT03192176|147297616|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|6.59||0.0005|TWO_SIDED|95.0|10.17|36.08||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||36.08|10.17|0.0005
74042616|NCT01468701|147636979|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.38|0.73|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.||0.73|0.38|
74042617|NCT01468701|147636983|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.6|1.57|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.||1.57|0.60|
74042618|NCT01468701|147636985|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.54|0.8|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.80|0.54|
74042619|NCT01068717|147636988|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric least squares (LS) mean|109.53|||||TWO_SIDED|90.0|102.67|116.85||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||116.85|102.67|
74042620|NCT01068717|147636988|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.37|||||TWO_SIDED|90.0|85.7|117.56||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||117.56|85.70|
74042621|NCT01068717|147636989|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.02|||||TWO_SIDED|90.0|91.29|107.41||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states||107.41|91.29|
74094237|NCT00667810|147739382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.623|TWO_SIDED|95.0|-3.04|5.07||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||5.07|-3.04|0.623
73879810|NCT03192176|147297616|SUPERIORITY||LSMean difference|17.6|STANDARD_ERROR_OF_MEAN|6.82||0.0102|TWO_SIDED|95.0|4.2|31.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||31.04|4.20|0.0102
73879811|NCT03192176|147297616|SUPERIORITY||LSMean difference|25.9|STANDARD_ERROR_OF_MEAN|6.83||0.0002|TWO_SIDED|95.0|12.42|39.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||39.29|12.42|0.0002
73879812|NCT03192176|147297616|SUPERIORITY||LSMean difference|25.8|STANDARD_ERROR_OF_MEAN|6.87||0.0002|TWO_SIDED|95.0|12.29|39.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||39.33|12.29|0.0002
73879813|NCT03192176|147297616|SUPERIORITY||LSMean difference|36.3|STANDARD_ERROR_OF_MEAN|6.97|<|0.0001|TWO_SIDED|95.0|22.58|49.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||49.98|22.58|<0.0001
73879814|NCT03192176|147297616|SUPERIORITY||LSMean difference|20.6|STANDARD_ERROR_OF_MEAN|6.94||0.0031|TWO_SIDED|95.0|7.0|34.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||34.29|7.00|0.0031
74012699|NCT00880399|147575707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.088|TWO_SIDED|95.0|-2.78|0.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.19|-2.78|0.0880
74094238|NCT00667810|147739383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.654|TWO_SIDED|95.0|-0.15|0.09|||Mixed Models Analysis|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 0.186 unit advantage for a bapineuzumab dose group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||0.09|-0.15|0.654
74094239|NCT00667810|147739384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.18||||0.085|TWO_SIDED|95.0|-15.38|1.02|||ANCOVA|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 15 ng/L advantage in p-tau for a bapineuzumab dose group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||1.02|-15.38|0.085
74012700|NCT00880399|147575707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.68||||0.0282|TWO_SIDED|95.0|-3.17|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.18|-3.17|0.0282
74012701|NCT00880399|147575708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9854|TWO_SIDED|95.0|-0.45|0.44|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.44|-0.45|0.9854
74012702|NCT00880399|147575708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.3476|TWO_SIDED|95.0|-0.66|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.23|-0.66|0.3476
74012703|NCT00880399|147575708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.0898|TWO_SIDED|95.0|-0.94|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.07|-0.94|0.0898
74012704|NCT00880399|147575708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.0928|TWO_SIDED|95.0|-0.95|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.07|-0.95|0.0928
74012705|NCT00880399|147575708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2937|TWO_SIDED|95.0|-0.93|0.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.28|-0.93|0.2937
74012706|NCT00880399|147575708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.0587|TWO_SIDED|95.0|-1.2|0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.02|-1.20|0.0587
74012707|NCT00880399|147575708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.195|TWO_SIDED|95.0|-1.14|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.23|-1.14|0.1950
74012708|NCT00880399|147575708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.0498|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.00|-1.40|0.0498
74012709|NCT00880399|147575709|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.14||||0.1731|TWO_SIDED|95.0|0.72|6.4|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 1||6.40|0.72|0.1731
74012710|NCT00880399|147575709|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.77||||0.7084|TWO_SIDED|95.0|0.2|2.97|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 1||2.97|0.20|0.7084
74012711|NCT00880399|147575709|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.6||||0.0247|TWO_SIDED|95.0|1.13|5.98|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 2||5.98|1.13|0.0247
74012712|NCT00880399|147575709|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||0.1862|TWO_SIDED|95.0|0.75|4.3|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 2||4.30|0.75|0.1862
74012713|NCT00880399|147575709|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.87||||0.063|TWO_SIDED|95.0|0.97|3.61|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 4||3.61|0.97|0.0630
74012714|NCT00880399|147575709|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.65||||0.1413|TWO_SIDED|95.0|0.85|3.23|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 4||3.23|0.85|0.1413
74012715|NCT00880399|147575709|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.77||||0.0806|TWO_SIDED|95.0|0.93|3.37|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 6||3.37|0.93|0.0806
74012716|NCT00880399|147575709|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.53||||0.2007|TWO_SIDED|95.0|0.8|2.92|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 6||2.92|0.80|0.2007
74012717|NCT00880399|147575710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.2523|TWO_SIDED|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.07|-0.25|0.2523
74012718|NCT00880399|147575710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.2639|TWO_SIDED|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.07|-0.25|0.2639
74094240|NCT00667810|147739385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.437|TWO_SIDED|95.0|-1.55|3.57|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||3.57|-1.55|0.437
74012719|NCT00880399|147575710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.0004|TWO_SIDED|95.0|-0.58|-0.17|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||-0.17|-0.58|0.0004
74012720|NCT00880399|147575710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.0348|TWO_SIDED|95.0|-0.43|-0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||-0.02|-0.43|0.0348
74012721|NCT00880399|147575710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.0166|TWO_SIDED|95.0|-0.62|-0.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.06|-0.62|0.0166
74012722|NCT00880399|147575710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.0014|TWO_SIDED|95.0|-0.75|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.18|-0.75|0.0014
74012723|NCT00880399|147575710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.0099|TWO_SIDED|95.0|-0.79|-0.11|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.11|-0.79|0.0099
74012724|NCT00880399|147575710|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.0059|TWO_SIDED|95.0|-0.83|-0.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.14|-0.83|0.0059
74012725|NCT00880399|147575711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.5473|TWO_SIDED|95.0|-2.04|1.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||1.08|-2.04|0.5473
74012726|NCT00880399|147575711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.9814|TWO_SIDED|95.0|-1.56|1.6|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||1.60|-1.56|0.9814
74012727|NCT00880399|147575711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51||||0.0515|TWO_SIDED|95.0|-3.03|0.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.01|-3.03|0.0515
74012728|NCT00880399|147575711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.468|TWO_SIDED|95.0|-2.09|0.96|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.96|-2.09|0.4680
74012729|NCT00880399|147575711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.1757|TWO_SIDED|95.0|-2.98|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.55|-2.98|0.1757
74012730|NCT00880399|147575711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15||||0.2048|TWO_SIDED|95.0|-2.93|0.63|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.63|-2.93|0.2048
74094241|NCT00667810|147739385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.423|TWO_SIDED|95.0|-1.54|3.66|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||3.66|-1.54|0.423
74012731|NCT00880399|147575711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16||||0.0312|TWO_SIDED|95.0|-4.12|-0.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.20|-4.12|0.0312
74012732|NCT00880399|147575711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.34||||0.0202|TWO_SIDED|95.0|-4.31|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.37|-4.31|0.0202
74012733|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.45||||0.7246|TWO_SIDED|95.0|-20.38|29.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 1||29.28|-20.38|0.7246
74012734|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.36||||0.0332|TWO_SIDED|95.0|2.2|52.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 1||52.52|2.20|0.0332
74012735|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.12||||0.5439|TWO_SIDED|95.0|-18.18|34.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 2||34.41|-18.18|0.5439
74012736|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.52||||0.3127|TWO_SIDED|95.0|-12.8|39.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 2||39.85|-12.80|0.3127
74012737|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.51||||0.2419|TWO_SIDED|95.0|-46.9|11.89|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 4||11.89|-46.90|0.2419
74012738|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Median Difference (Net)|21.11||||0.1606|TWO_SIDED|95.0|-8.43|50.64|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 4||50.64|-8.43|0.1606
74012739|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.48||||0.7412||95.0|-22.21|31.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 6||31.16|-22.21|0.7412
74012740|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.47||||0.3974|TWO_SIDED|95.0|-15.19|38.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 6||38.14|-15.19|0.3974
74012741|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.52||||0.1397|TWO_SIDED|95.0|-26.83|3.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 1||3.79|-26.83|0.1397
74094242|NCT00667810|147739386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.212|TWO_SIDED|95.0|-3.4|0.76|||Mixed Models Analysis|||||0.76|-3.40|0.212
74094243|NCT00667810|147739386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.725|TWO_SIDED|95.0|-1.76|2.52|||Mixed Models Analysis|||||2.52|-1.76|0.725
74094244|NCT00667810|147739387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.149|TWO_SIDED|95.0|-1.15|7.56|||Mixed Models Analysis|||||7.56|-1.15|0.149
74012742|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.9||||0.0026|TWO_SIDED|95.0|-39.4|-8.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 1||-8.41|-39.40|0.0026
74012743|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.67||||0.3206|TWO_SIDED|95.0|-22.85|7.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 2||7.50|-22.85|0.3206
74012744|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.67||||0.0015|TWO_SIDED|95.0|-39.86|-9.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 2||-9.49|-39.86|0.0015
73879815|NCT03192176|147297616|SUPERIORITY||LSMean difference|22.9|STANDARD_ERROR_OF_MEAN|6.85||0.0009|TWO_SIDED|95.0|9.43|36.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.38|9.43|0.0009
73888009|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.1074|TWO_SIDED|95.0|-5.9|59.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.8|-5.9|0.1074
74012745|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.71||||0.2157|TWO_SIDED|95.0|-27.7|6.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 4||6.28|-27.70|0.2157
74012746|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.31||||0.0784|TWO_SIDED|95.0|-32.37|1.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 4||1.75|-32.37|0.0784
74012747|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.84||||0.3345|TWO_SIDED|95.0|-7.09|20.78|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 6||20.78|-7.09|0.3345
74012748|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.25||||0.6471|TWO_SIDED|95.0|-17.19|10.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 6||10.70|-17.19|0.6471
74012749|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.8071|TWO_SIDED|95.0|-16.95|21.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 1||21.75|-16.95|0.8071
74012750|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.3||||0.3564|TWO_SIDED|95.0|-29.11|10.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 1||10.52|-29.11|0.3564
74012751|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.86||||0.122|TWO_SIDED|95.0|-36.0|4.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 2||4.28|-36.00|0.1220
74012752|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.25||||0.0313|TWO_SIDED|95.0|-42.49|-2.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 2||-2.01|-42.49|0.0313
74094245|NCT00667810|147739387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.01||||0.375|TWO_SIDED|95.0|-2.44|6.46|||Mixed Models Analysis|||||6.46|-2.44|0.375
74012753|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.15||||0.8861|TWO_SIDED|95.0|-27.45|31.76|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 4||31.76|-27.45|0.8861
74012754|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.67||||0.9132|TWO_SIDED|95.0|-31.87|28.53|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 4||28.53|-31.87|0.9132
74012755|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.09||||0.7844|TWO_SIDED|95.0|-33.55|25.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6||25.37|-33.55|0.7844
74012756|NCT00880399|147575712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.8497|TWO_SIDED|95.0|-27.33|33.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6||33.14|-27.33|0.8497
74012757|NCT00880399|147575713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4814|TWO_SIDED|95.0|-0.83|0.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.39|-0.83|0.4814
74012758|NCT00880399|147575713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.6179|TWO_SIDED|95.0|-0.47|0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.79|-0.47|0.6179
74012759|NCT00880399|147575713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.5022|TWO_SIDED|95.0|-0.44|0.21|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.21|-0.44|0.5022
74012760|NCT00880399|147575713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.1389|TWO_SIDED|95.0|-0.57|0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.08|-0.57|0.1389
74012761|NCT00880399|147575713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.9663|TWO_SIDED|95.0|-0.36|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.38|-0.36|0.9663
74012762|NCT00880399|147575713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.1311|TWO_SIDED|95.0|-0.67|0.09|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.09|-0.67|0.1311
74094246|NCT00667810|147739388|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||Not specifed.|Log Rank|||||||0.030
74012763|NCT00880399|147575713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.1362|TWO_SIDED|95.0|-0.73|0.1|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.10|-0.73|0.1362
74012764|NCT00880399|147575713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.0275|TWO_SIDED|95.0|-0.91|-0.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.05|-0.91|0.0275
74012765|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52||||0.0606|TWO_SIDED|95.0|-0.02|1.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 1||1.06|-0.02|0.0606
74012766|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69||||0.0132|TWO_SIDED|95.0|0.15|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 1||1.24|0.15|0.0132
74012767|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94||||0.001|TWO_SIDED|95.0|0.38|1.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 2||1.50|0.38|0.0010
74012768|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84||||0.0034|TWO_SIDED|95.0|0.28|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 2||1.40|0.28|0.0034
74012769|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.6692|TWO_SIDED|95.0|-0.47|0.72|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 4||0.72|-0.47|0.6692
74012770|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.82||||0.0078|TWO_SIDED|95.0|0.22|1.42|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 4||1.42|0.22|0.0078
74094247|NCT00667810|147739388|SUPERIORITY_OR_OTHER|||||||0.567|TWO_SIDED||||||Log Rank|||||||0.567
74094248|NCT00667810|147739389|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED||||||Log Rank|||||||0.079
74094249|NCT00667810|147739389|SUPERIORITY_OR_OTHER|||||||0.675|TWO_SIDED||||||Log Rank|||||||0.675
73879816|NCT03192176|147297616|SUPERIORITY||LSMean difference|22.8|STANDARD_ERROR_OF_MEAN|6.8||0.0009|TWO_SIDED|95.0|9.42|36.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.19|9.42|0.0009
74012771|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66||||0.044|TWO_SIDED|95.0|0.02|1.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 6||1.30|0.02|0.0440
74012772|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.0181|TWO_SIDED|95.0|0.13|1.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 6||1.41|0.13|0.0181
74012773|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.1484|TWO_SIDED|95.0|-0.14|0.92|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 1||0.92|-0.14|0.1484
74012774|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.0108|TWO_SIDED|95.0|0.16|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 1||1.24|0.16|0.0108
74012775|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.0361||95.0|0.04|1.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 2||1.16|0.04|0.0361
74012776|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.0418|TWO_SIDED|95.0|0.02|1.15|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 2||1.15|0.02|0.0418
74012777|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.9305|TWO_SIDED|95.0|-0.64|0.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 4||0.58|-0.64|0.9305
74012778|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.0141|TWO_SIDED|95.0|0.16|1.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 4||1.39|0.16|0.0141
74012779|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65||||0.0562|TWO_SIDED|95.0|-0.02|1.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6||1.31|-0.02|0.0562
74094250|NCT00667810|147739390|SUPERIORITY_OR_OTHER|||||||0.846|TWO_SIDED||||||Log Rank|||Not spsecified.||||0.846
74012780|NCT00880399|147575714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.0296|TWO_SIDED|95.0|0.07|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6||1.40|0.07|0.0296
74012781|NCT00880399|147575718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2||||0.0735|TWO_SIDED|95.0|-0.21|4.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||4.61|-0.21|0.0735
74012782|NCT00880399|147575718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35||||0.2905|TWO_SIDED|95.0|-1.17|3.86|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||3.86|-1.17|0.2905
74012783|NCT00880399|147575718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.05||||0.4327|TWO_SIDED|95.0|-1.6|3.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||3.70|-1.60|0.4327
74012784|NCT00880399|147575718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.01||||0.4642|TWO_SIDED|95.0|-1.73|3.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||3.75|-1.73|0.4642
74012785|NCT00880399|147575718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.48||||0.285|TWO_SIDED|95.0|-1.26|4.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||4.23|-1.26|0.2850
74012786|NCT00880399|147575718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.5984|TWO_SIDED|95.0|-2.08|3.59|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||3.59|-2.08|0.5984
74012787|NCT00880399|147575718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.21||||0.4192|TWO_SIDED|95.0|-1.76|4.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||4.19|-1.76|0.4192
74012788|NCT00880399|147575718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0.6766|TWO_SIDED|95.0|-2.42|3.71|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||3.71|-2.42|0.6766
74012789|NCT00880399|147575719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9951|TWO_SIDED|95.0|-1.26|1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||1.25|-1.26|0.9951
74012790|NCT00880399|147575719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.894|TWO_SIDED|95.0|-1.17|1.34|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||1.34|-1.17|0.8940
74012791|NCT00880399|147575719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.8195|TWO_SIDED|95.0|-1.61|1.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||1.28|-1.61|0.8195
74012792|NCT00880399|147575719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.4106|TWO_SIDED|95.0|-0.84|2.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||2.05|-0.84|0.4106
74012793|NCT00880399|147575719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.9403|TWO_SIDED|95.0|-1.71|1.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||1.85|-1.71|0.9403
74012794|NCT00880399|147575719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.5206|TWO_SIDED|95.0|-2.36|1.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||1.20|-2.36|0.5206
74012795|NCT00880399|147575719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.714|TWO_SIDED|95.0|-2.3|1.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||1.58|-2.30|0.7140
74012796|NCT00880399|147575719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.26||||0.0234|TWO_SIDED|95.0|-4.22|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.31|-4.22|0.0234
74012797|NCT04353284|147575722|SUPERIORITY||Mean Difference (Net)|0.74||||0.06|TWO_SIDED|95.0|-0.03|1.51|||Mixed Models Analysis|||This analysis compares the change from baseline between treatment arms.||1.51|-0.03|0.06
74012798|NCT04353284|147575723|SUPERIORITY||Mean Difference (Net)|0.06||||0.87|TWO_SIDED|95.0|-0.7|0.83|||Mixed Models Analysis|||||0.83|-0.70|0.87
74094251|NCT00667810|147739390|SUPERIORITY_OR_OTHER|||||||0.797|TWO_SIDED||||||Log Rank|||||||0.797
74012799|NCT04353284|147575724|SUPERIORITY||Mean Difference (Net)|0.23||||0.69|TWO_SIDED|95.0|-0.94|1.4|||Mixed Models Analysis|||||1.4|-0.94|0.69
74012800|NCT04353284|147575725|SUPERIORITY||Odds Ratio (OR)|1.3||||0.71|TWO_SIDED|95.0|0.33|5.09|||GEE|||Nasopharyngeal Swab Samples analyzed.||5.09|0.33|0.71
74012801|NCT04353284|147575725|SUPERIORITY||Odds Ratio (OR)|0.4||||0.17|TWO_SIDED|95.0|0.11|1.47|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||1.47|0.11|0.17
74094252|NCT00667810|147739391|SUPERIORITY_OR_OTHER|||||||0.933|TWO_SIDED||||||Log Rank|||||||0.933
74094253|NCT00667810|147739391|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Log Rank|||||||0.714
74012802|NCT04353284|147575726|SUPERIORITY||Odds Ratio (OR)|3.05||||0.03|TWO_SIDED|95.0|1.12|8.26|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||||8.26|1.12|0.03
74012803|NCT04353284|147575726|SUPERIORITY||Odds Ratio (OR)|1.23||||0.68|TWO_SIDED|95.0|0.47|3.23|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||3.23|0.47|0.68
74012804|NCT04353284|147575727|SUPERIORITY||Odds Ratio (OR)|6.28||||0.1|TWO_SIDED|95.0|0.7|56.6|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||||56.60|0.70|0.10
74012805|NCT04353284|147575727|SUPERIORITY||Odds Ratio (OR)|0.9||||0.87|TWO_SIDED|95.0|0.25|3.23|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||3.23|0.25|0.87
74012806|NCT04353284|147575728|SUPERIORITY||Mean Difference (Net)|-6.6||||0.02|TWO_SIDED|95.0|-12.1|-1.2|||Mixed Models Analysis|||||-1.2|-12.1|0.02
74012807|NCT04353284|147575729|SUPERIORITY||Mean Difference (Net)|-2.1||||0.48|TWO_SIDED|95.0|-7.9|3.7|||Mixed Models Analysis|||||3.7|-7.9|0.48
74012808|NCT04353284|147575730|SUPERIORITY||Mean Difference (Net)|1.0||||0.16|TWO_SIDED|95.0|-0.4|2.3|||Mixed Models Analysis|||||2.3|-0.4|0.16
74012809|NCT04353284|147575731|SUPERIORITY||Mean Difference (Net)|0.7||||0.34|TWO_SIDED|95.0|-0.7|2.1|||Mixed Models Analysis|||||2.1|-0.7|0.34
74012810|NCT02424253|147575777|SUPERIORITY||LS Difference|-0.35|||=|0.249|TWO_SIDED|90.0|-1.21|0.51||1-sided p-value.|ANCOVA|The ANCOVA model included baseline value and treatment.||Change from baseline||0.51|-1.21|= 0.249
74094254|NCT00667810|147739393|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.277
74012811|NCT02424253|147575778|SUPERIORITY||LS Difference|-5.06|||=|0.01|TWO_SIDED|90.0|-8.66|-1.46||1-sided p-value.|ANCOVA|The ANCOVA model included baseline EASI, stratification variable (worst daily pruritus NRS ≤ 7.5 or \> 7.5) and treatment.||Change from baseline analysis||-1.46|-8.66|= 0.01
74012812|NCT03998046|147575779|SUPERIORITY|||||||0.85|||||||Chi-squared|||||||.85
74012813|NCT03998046|147575781|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||.20
74012814|NCT03998046|147575782|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||.38
74012815|NCT03998046|147575783|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.02
74012816|NCT03998046|147575784|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
74012817|NCT03998046|147575785|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||.13
74012818|NCT03998046|147575786|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||.61
74012819|NCT03998046|147575787|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||.56
74012820|NCT02370615|147575788|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|2.012|||||TWO_SIDED|90.0|1.632|2.481||||||Analysis for TAK 272F||2.481|1.632|
74012821|NCT02370615|147575788|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|0.089|||||TWO_SIDED|90.0|0.064|0.123||||||Analysis for TAK 272-M-I||0.123|0.064|
74012822|NCT02370615|147575789|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|4.888|||||TWO_SIDED|90.0|4.137|5.777||||||Analysis for TAK 272F||5.777|4.137|
74012823|NCT02370615|147575790|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|4.702|||||TWO_SIDED|90.0|3.969|5.569||||||Analysis for TAK 272F||5.569|3.969|
74012824|NCT02370615|147575790|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|0.023|||||TWO_SIDED|90.0|0.012|0.045||||||Analysis for TAK 272-M-I||0.045|0.012|
74012825|NCT02370615|147575792|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.349|||||TWO_SIDED|90.0|1.117|1.628||||||||1.628|1.117|
74012826|NCT02370615|147575793|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.02|||||TWO_SIDED|90.0|0.919|1.131||||||||1.131|0.919|
74012827|NCT02370615|147575794|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.155|||||TWO_SIDED|90.0|1.035|1.289||||||||1.289|1.035|
74012828|NCT02370615|147575796|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.235|||||TWO_SIDED|90.0|1.1|1.387||||||Analysis for Midazolam||1.387|1.100|
74012829|NCT02370615|147575796|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|0.887|||||TWO_SIDED|90.0|0.781|1.008||||||Analysis for 1'Hydroxymidazolam||1.008|0.781|
74012830|NCT02370615|147575797|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.422|||||TWO_SIDED|90.0|1.29|1.568||||||Analysis for Midazolam||1.568|1.290|
74012831|NCT02370615|147575797|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.081|||||TWO_SIDED|90.0|1.008|1.16||||||Analysis for 1'Hydroxymidazolam||1.160|1.008|
74012832|NCT02370615|147575798|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.425|||||TWO_SIDED|90.0|1.291|1.574||||||Analysis for Midazolam||1.574|1.291|
74012833|NCT02370615|147575798|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.061|||||TWO_SIDED|90.0|0.986|1.143||||||Analysis for 1'Hydroxymidazolam||1.143|0.986|
74012834|NCT02290873|147575805|SUPERIORITY||Difference in Rates|0.8961|||<|0.0001|TWO_SIDED|95.0|0.8505|0.9416||P-value calculated from a Cochran-Mantel-Haenszel test accounting for fentanyl strata.|Cochran-Mantel-Haenszel|||||0.9416|0.8505|<0.0001
74012835|NCT02290873|147575806|SUPERIORITY||Hazard Ratio (HR)|6.133|||<|0.0001|TWO_SIDED|95.0|4.416|8.517|||Log Rank|||||8.517|4.416|<0.0001
74012836|NCT01519765|147575812|SUPERIORITY_OR_OTHER|||||||0.1611|||||||Fisher Exact|||A consecutive sample will be used as women are recruited. Based on an 80% power and an alpha of 0.05, a sample size of 103 subjects in each arm is required to detect a 20% difference between deliveries within 24hrs between the two treatment arms. An effect size of 20% was selected as this is thought to be a clinically significant difference. This is based on the Wing study showing 50% delivery within 24 hrs with vaginal misoprostol.||||0.1611
74012837|NCT01519765|147575813|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||t-test, 2 sided|||||||0.018
74094255|NCT00667810|147739393|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.996
74094256|NCT00667810|147739395|SUPERIORITY_OR_OTHER|||||||0.855|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.855
74012838|NCT01519765|147575814|SUPERIORITY_OR_OTHER|||||||0.0623|||||||Kruskal-Wallis|||||||0.0623
74094257|NCT00667810|147739395|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.423
74094258|NCT00667810|147739396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.516|TWO_SIDED|95.0|-0.65|0.33|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.||0.33|-0.65|0.516
74094259|NCT00667810|147739396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.257|TWO_SIDED|95.0|-0.79|0.21|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.||0.21|-0.79|0.257
74094260|NCT00667810|147739397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.238|TWO_SIDED|95.0|-0.96|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.||0.24|-0.96|0.238
73879817|NCT03192176|147297616|SUPERIORITY||LSMean difference|13.8|STANDARD_ERROR_OF_MEAN|6.71||0.0408|TWO_SIDED|95.0|0.58|26.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||26.97|0.58|0.0408
73879818|NCT03192176|147297616|SUPERIORITY||LSMean difference|20.0|STANDARD_ERROR_OF_MEAN|6.72||0.0031|TWO_SIDED|95.0|6.77|33.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||33.21|6.77|0.0031
74094261|NCT00667810|147739397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.564|TWO_SIDED|95.0|-0.78|0.43|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.||0.43|-0.78|0.564
74094262|NCT00505375|147739404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.0014
74094263|NCT03709823|147739414|SUPERIORITY||LS Mean Difference vs. Placebo|-20.48||||0.0002|TWO_SIDED|95.0|-31.141|-9.821||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-9.821|-31.141|0.0002
74094264|NCT03709823|147739414|SUPERIORITY||LS Mean Difference vs. Placebo|-22.07|||<|0.0001|TWO_SIDED|95.0|-32.791|-11.342||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-11.342|-32.791|< 0.0001
74094265|NCT03709823|147739414|SUPERIORITY||LS Mean Difference vs. Placebo|-5.9||||0.2708|TWO_SIDED|95.0|-16.463|4.66||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||4.660|-16.463|0.2708
73879819|NCT03192176|147297616|SUPERIORITY||LSMean difference|22.1|STANDARD_ERROR_OF_MEAN|6.76||0.0012|TWO_SIDED|95.0|8.8|35.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||35.40|8.80|0.0012
74012839|NCT01519765|147575815|SUPERIORITY_OR_OTHER|||||||0.1141|TWO_SIDED||||||Kruskal-Wallis|||||||0.1141
73879820|NCT03192176|147297616|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|6.87|<|0.0001|TWO_SIDED|95.0|16.39|43.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||43.42|16.39|<0.0001
74012840|NCT01519765|147575816|SUPERIORITY_OR_OTHER|||||||0.4469|TWO_SIDED||||||Fisher Exact|||||||0.4469
74012841|NCT01519765|147575817|SUPERIORITY_OR_OTHER|||||||0.4469|TWO_SIDED||||||Fisher Exact|||||||0.4469
74012842|NCT01519765|147575818|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||Kruskal-Wallis|||||||0.093
74094266|NCT03709823|147739414|SUPERIORITY||LS Mean Difference vs. Placebo|-2.81||||0.6018|TWO_SIDED|95.0|-13.438|7.82||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||7.820|-13.438|0.6018
74094267|NCT03709823|147739414|SUPERIORITY||LS Mean Difference vs. Commercial Sched.|-12.17||||0.1025|TWO_SIDED|95.0|-26.869|2.535||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||2.535|-26.869|0.1025
74094268|NCT03709823|147739415|SUPERIORITY||LS Mean Difference vs. Placebo|-14.61||||0.001|TWO_SIDED|95.0|-23.216|-6.009||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-6.009|-23.216|0.0010
74094269|NCT03709823|147739415|SUPERIORITY||LS Mean Difference vs. Placebo|-16.2||||0.0003|TWO_SIDED|95.0|-24.862|-7.548||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-7.548|-24.862|0.0003
74094270|NCT03709823|147739416|SUPERIORITY||LS Mean Difference vs. Placebo|-12.41||||0.0091|TWO_SIDED|95.0|-21.695|-3.135||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-3.135|-21.695|0.0091
74094271|NCT03709823|147739416|SUPERIORITY||LS Mean Difference vs. Placebo|-9.3||||0.0518|TWO_SIDED|95.0|-18.667|0.075||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||0.075|-18.667|0.0518
74012843|NCT01519765|147575819|SUPERIORITY_OR_OTHER|||||||0.2417|TWO_SIDED||||||Fisher Exact|||||||0.2417
74012844|NCT01519765|147575820|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
74012845|NCT01519765|147575821|SUPERIORITY_OR_OTHER|||||||0.1054|TWO_SIDED||||||Fisher Exact|||||||0.1054
74094272|NCT04870138|147739419|OTHER|||||||1||||||One-sided Fisher's Exact Test with alpha = 0.05|Fisher Exact|||||||1.000
74094273|NCT04870138|147739421|OTHER||||||<|0.0001|||||||t-test, 1 sided|One-sided single sample t-test with alpha=0.05||Null hypothesis: The proportion of the strain in the inoculum = 0.5||||<0.0001
74094274|NCT02633488|147739446|EQUIVALENCE|equivalence defined as less that 2 SD in FMD between 2 treatments|||||>|0.05||||||FMD % change exceeded the threshold of our statistical significance test, i.e. the null hypothesis that there was no effect of metformin remained tenable.|t-test, 2 sided|||||||>0.05
74094275|NCT03167723|147739450|NON_INFERIORITY|15% Non-Inferiority||||||0.036|||||||Farrington-Manning|||||||0.036
74094276|NCT01175811|147739460|SUPERIORITY_OR_OTHER||LSmean difference|0.01|||||TWO_SIDED|95.0|-0.14|0.16||||||||0.16|-0.14|
74042622|NCT01068717|147636989|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.21|||||TWO_SIDED|90.0|96.86|103.67||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||103.67|96.86|
74012846|NCT01519765|147575822|SUPERIORITY_OR_OTHER|||||||0.8043|TWO_SIDED||||||Fisher Exact|||||||0.8043
74012847|NCT01519765|147575823|SUPERIORITY_OR_OTHER|||||||0.797|TWO_SIDED||||||Fisher Exact|||||||0.797
74012848|NCT01519765|147575824|SUPERIORITY_OR_OTHER|||||||0.751|||||||Fisher Exact|||||||0.751
74012849|NCT01519765|147575825|SUPERIORITY_OR_OTHER|||||||0.6244|TWO_SIDED||||||Fisher Exact|||||||0.6244
74012850|NCT01519765|147575826|SUPERIORITY_OR_OTHER|||||||0.7906|TWO_SIDED||||||Fisher Exact|||||||0.7906
74012851|NCT01519765|147575827|SUPERIORITY_OR_OTHER|||||||0.5118|TWO_SIDED||||||Fisher Exact|||||||0.5118
74042623|NCT01068717|147636991|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||TWO_SIDED|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||106.91|97.96|
74042624|NCT01068717|147636991|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.78|||||TWO_SIDED|90.0|96.61|103.05||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||103.05|96.61|
74094277|NCT01175811|147739461|SUPERIORITY_OR_OTHER||LSmean Difference|0.0|||||TWO_SIDED|95.0|-0.15|0.16||||||||0.16|-0.15|
74012852|NCT01519765|147575828|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
74012853|NCT01519765|147575829|SUPERIORITY_OR_OTHER|||||||0.741|TWO_SIDED||||||Fisher Exact|||||||0.741
74012854|NCT01519765|147575830|SUPERIORITY_OR_OTHER|||||||0.579|TWO_SIDED||||||Kruskal-Wallis|||||||0.579
74012855|NCT01519765|147575831|SUPERIORITY_OR_OTHER|||||||0.8062|||||||Kruskal-Wallis|||Score for Nausea and vomiting||||.8062
74012856|NCT01519765|147575831|SUPERIORITY_OR_OTHER|||||||0.1505|||||||Kruskal-Wallis|||Effectiveness||||0.1505
74012857|NCT01519765|147575831|SUPERIORITY_OR_OTHER|||||||0.1223|||||||Kruskal-Wallis|||Patient concern||||0.1223
74012858|NCT01519765|147575831|SUPERIORITY_OR_OTHER|||||||0.538||||||Patient satisfaction|Kruskal-Wallis|||Labor satisfaction||||0.5380
74012859|NCT01519765|147575832|SUPERIORITY_OR_OTHER|||||||0.2868||||||This is the overall p value of all rows.|Chi-squared|||||||0.2868
74012860|NCT02354222|147575864|SUPERIORITY||Least Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-1.16|-0.72|||ANCOVA|||||-0.72|-1.16|<0.001
74012861|NCT02354222|147575865|SUPERIORITY||Least Squares Mean Difference|-15.6|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-23.3|-7.9|||ANCOVA|||||-7.9|-23.3|<0.001
74012862|NCT02354222|147575866|SUPERIORITY||Least Squares Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|0.63|2.23|||ANCOVA|||||2.23|0.63|<0.001
74012863|NCT02354222|147575867|SUPERIORITY||Least Squares Mean Difference|-55.9|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-74.1|-37.6|||ANCOVA|||||-37.6|-74.1|<0.001
74012864|NCT02354222|147575868|SUPERIORITY||Least Squares Mean Difference|-37.6|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-49.9|-25.2|||ANCOVA|||||-25.2|-49.9|<0.001
74012865|NCT01699542|147575886|SUPERIORITY|||||||0.159|||||||Generalized Linear Model|||||||0.159
74012866|NCT00432042|147575915|NON_INFERIORITY_OR_EQUIVALENCE|Measles difference|Mean Difference (Final Values)|1.14|||||TWO_SIDED|95.0|-1.62|4.82|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||4.82|-1.62|
74012867|NCT00432042|147575915|NON_INFERIORITY_OR_EQUIVALENCE|Mumps difference|Mean Difference (Final Values)|-1.83|||||TWO_SIDED|95.0|-4.21|1.1|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||1.10|-4.21|
74012868|NCT00432042|147575915|NON_INFERIORITY_OR_EQUIVALENCE|Rubella difference|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-3.19|1.35|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||1.35|-3.19|
74012869|NCT00432042|147575915|NON_INFERIORITY_OR_EQUIVALENCE|Varicella difference|Mean Difference (Final Values)|2.53|||||TWO_SIDED|95.0|-0.41|6.58|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||6.58|-0.41|
74012870|NCT00432042|147575916|NON_INFERIORITY_OR_EQUIVALENCE|Hepatitis B difference|Mean Difference (Final Values)|1.36|||||TWO_SIDED|95.0|-0.29|4.24|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||4.24|-0.29|
74012871|NCT00432042|147575916|NON_INFERIORITY_OR_EQUIVALENCE|Haemophilus Influenza type B difference|Mean Difference (Final Values)|2.97|||||TWO_SIDED|95.0|-0.17|6.89|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||6.89|-0.17|
74012872|NCT00432042|147575917|NON_INFERIORITY_OR_EQUIVALENCE|Anti-PT difference|GMT ratio|0.97|||||TWO_SIDED|95.0|0.88|1.08|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.08|0.88|
74012873|NCT00432042|147575917|NON_INFERIORITY_OR_EQUIVALENCE|Anti-FHA difference|GMT ratio|1.09|||||TWO_SIDED|95.0|0.98|1.23|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.23|0.98|
74094278|NCT01175811|147739462|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value is for the comparison of participants achieving \<=6.5% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.344
74012874|NCT00432042|147575917|NON_INFERIORITY_OR_EQUIVALENCE|Anti-PRN difference|GMT ratio|1.18|||||TWO_SIDED|95.0|1.03|1.36|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.36|1.03|
74012875|NCT02822885|147575918|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
74012876|NCT02822885|147575919|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
74094279|NCT01175811|147739462|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||P-value is for the comparison of participants achieving \<=7.0% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.822
74012877|NCT02822885|147575920|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
74012878|NCT02822885|147575921|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
74012879|NCT02822885|147575922|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
74012880|NCT03924752|147575933|OTHER|A two-way repeated-measures analysis of variance (ANOVA) was performed on different walking conditions (including the baseline of not wearing the exoskeleton) on the subject's overground self-selected walking speed across different locomotion modes by setting the significant value to 0.05. Two independent variables were assistance type (Exo vs No Exo) and different locomotion modes.||||||0.9547||||||This presents the effect of exoskeleton assistance on the user's preferred overground walking speed across different locomotion modes.|ANOVA|||||||0.9547
74012881|NCT03803059|147575934|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using Wilcoxon signed rank test. Testing hypothesis is that the mean change from baseline is zero||||<0.01
74012882|NCT03803059|147575935|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using Wilcoxon signed rank test. Testing hypothesis is that the mean score is equal to 4 (no change).||||<0.01
74012883|NCT03803059|147575936|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using the Wilcoxon signed rank test. Testing hypothesis is that the mean score is equal to 4.||||<0.01
74012884|NCT03803059|147575937|SUPERIORITY|||||||0.051|||||||t-test, 1 sided|||Calculated using paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.051
74012885|NCT03803059|147575938|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||Calculated from paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||<0.01
74012886|NCT03803059|147575939|SUPERIORITY|||||||0.331|||||||t-test, 1 sided|||Calculated from paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.331
74012887|NCT03803059|147575940|SUPERIORITY|||||||0.863|||||||t-test, 2 sided|||Calculated using the paired t test. Testing hypothesis is that the mean change from baseline is zero.||||0.863
74012888|NCT03803059|147575941|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||Calculated using the paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.048
74094280|NCT01175811|147739462|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||P-value is for the comparison of participants achieving \<=6.5% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.417
74094281|NCT01175811|147739462|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||P-value is for the comparison of participants achieving \<=7.0% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.392
73888010|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|55.3||||0.0064|TWO_SIDED|95.0|15.8|94.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||94.9|15.8|0.0064
74012889|NCT03803059|147575942|SUPERIORITY|||||||0.355||||||P-value reported is for viscoelastic deformation.|t-test, 2 sided|at significance level alpha+0.05||Calculated using the paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.355
74012890|NCT03803059|147575943|SUPERIORITY|||||||0.859||||||Calculated with a paired T test. Testing hypothesis is that the mean change from baseline is zero.|t-test, 2 sided|||Calculated using the paired t test. Testing hypothesis is that the mean change from baseline is zero.||||0.859
74012891|NCT03803059|147575944|EQUIVALENCE|.A binomial (sign) test was performed to test if the the proportion of the combined designated favorable evaluations/responses is equal to the combined designated negative evaluations/responses for each question|||||<|0.01|||||||Sign test|||Patient satisfaction questionnaires were tabulated, and the frequency and percentage of all response options were reported for each question and time point calculated from the binomial (sign) test. The testing hypothesis is that the proportion of favorable responses is equal to the unfavorable||||<0.01
74012892|NCT03803059|147575945|SUPERIORITY|||||||0.031||||||All statistical tests were 2-sided at significance level alpha=0.05. No multiple testing corrections were considered in the study.|t-test, 2 sided|||The null hypothesis that the mean change from baseline is zero was tested using a paired t-test||||0.031
74012893|NCT04013529|147575948|SUPERIORITY||||||=|0.9|||||||ANCOVA|||||||=0.90
74012894|NCT04013529|147575949|SUPERIORITY||||||=|0.88|||||||ANCOVA|||||||= 0.88
74012895|NCT04013529|147575950|SUPERIORITY||||||<|0.17|||||||ANCOVA|||||||< 0.17
74012896|NCT04013529|147575951|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||< 0.05
74012897|NCT04013529|147575952|SUPERIORITY||||||=|0.81|||||||ANCOVA|||||||= 0.81
74012898|NCT03099187|147575982|SUPERIORITY||Difference in Group Means|-134.6||||0.6777|TWO_SIDED|95.0|-772.4|503.3||p-value was not adjusted for multiplicity and is provided for descriptive purpose only|t-test, 2 sided|||Primary Analysis in 2019. Mean FVC decline comparison between treatment groups using a Student's t-test with a two-sided significance level of 0.05||503.3|-772.4|0.6777
74012899|NCT03099187|147575982|SUPERIORITY||Difference in Group Means|-216.0||||0.4682|TWO_SIDED|95.0|-803.6|371.7||p-value was not adjusted for multiplicity and is provided for descriptive purpose only|Student's t-test|||Final Analysis in 2020. Mean FVC decline comparison between treatment groups using a Student's t-test with a two-sided significance level of 0.05||371.7|-803.6|0.4682
74012900|NCT03099187|147575983|SUPERIORITY|||||||0.0383|||||||rank ANCOVA|||Primary Analysis in 2019||||0.0383
74012901|NCT03099187|147575983|SUPERIORITY|||||||0.0239|||||||rank ANCOVA|||Final Analysis in 2020||||0.0239
74012902|NCT03099187|147575984|SUPERIORITY||Overall Mean Difference|95.3||||0.0018|TWO_SIDED|95.0|35.9|154.6||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Student's t-test|||Primary Analysis in 2019||154.6|35.9|0.0018
74012903|NCT03099187|147575984|SUPERIORITY||Overall Mean Difference|84.3||||0.0096|TWO_SIDED|95.0|20.7|147.8||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Student's t-test|||Final Analysis in 2020||147.8|20.7|0.0096
74012904|NCT03099187|147575985|SUPERIORITY||Odds Ratio (OR)|0.42||||0.0006|TWO_SIDED|95.0|0.25|0.69||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Primary Analysis in 2019||0.69|0.25|0.0006
74012905|NCT03099187|147575985|SUPERIORITY||Odds Ratio (OR)|0.43||||0.0009|TWO_SIDED|95.0|0.26|0.71||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Final Analysis in 2020||0.71|0.26|0.0009
74012906|NCT03099187|147575986|SUPERIORITY||Odds Ratio (OR)|0.44||||0.0114|TWO_SIDED|95.0|0.23|0.84||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Primary Analysis in 2019||0.84|0.23|0.0114
74012907|NCT03099187|147575986|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0168|TWO_SIDED|95.0|0.24|0.88||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Final Analysis in 2020||0.88|0.24|0.0168
74012908|NCT03099187|147575987|SUPERIORITY|||||||0.0874||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Primary Analysis in 2019||||0.0874
74012909|NCT03099187|147575987|SUPERIORITY|||||||0.1191||||||p-values are not adjusted for multiplicity and are provided for descriptive purpose only.|rank ANCOVA|||Final Analysis in 2020||||0.1191
74012910|NCT03099187|147575988|SUPERIORITY|||||||0.0395||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Primary Analysis in 2019||||0.0395
74012911|NCT03099187|147575988|SUPERIORITY|||||||0.0299||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Final Analysis in 2020||||0.0299
74012912|NCT03099187|147575989|SUPERIORITY||Hodges-Lehmann Median Difference|0.0||||0.7788|TWO_SIDED|95.0|-5.0|5.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||5.00|-5.00|0.7788
74012913|NCT03099187|147575989|SUPERIORITY||Hodges-Lehmann Median Difference|0.0||||0.8289|TWO_SIDED|95.0|-5.0|5.0||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate|rank ANCOVA|||Final Analysis in 2020||5.00|-5.00|0.8289
74012914|NCT03099187|147575990|SUPERIORITY||Hodges-Lehmann Median difference|0.29||||0.1872|TWO_SIDED|95.0|-0.45|1.04||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||1.04|-0.45|0.1872
74094282|NCT00415194|147739471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.082|TWO_SIDED|95.0|0.75|1.02|||Stratified Log Rank|||||1.02|0.75|0.082
74094283|NCT00415194|147739472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.166|TWO_SIDED|95.0|0.76|1.03|||Stratified Log Rank|||||1.03|0.76|0.166
74094284|NCT00415194|147739473|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Unadjusted normal distribution|p-value is based on an unadjusted, normal distribution approximation for differences in rates.||||||0.061
74094285|NCT00415194|147739474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.811|TWO_SIDED|95.0|0.56|1.53|||Stratified Log Rank|||||1.53|0.56|0.811
74094286|NCT00415194|147739475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.2|TWO_SIDED|95.0|0.69|1.07|||Stratified Log Rank|||||1.07|0.69|0.20
74094287|NCT01297465|147739477|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.947|||TWO_SIDED|95.0|-3.15|0.59|||ANOVA|ANOVA model adjusted for treatment and country|The primary efficacy variable was to be analyzed using an analysis of variance (ANOVA) model, adjusted for treatment and country.|The null hypothesis was that the difference between the mean number of oocytes is less than (-3) or greater than (+3) between the two treatment arm. The alternate hypothesis was that the difference is between (-3) and (+3). The study had 80% power to show that the group randomized to Pergoveris® has an absolute difference of no more than 3 oocytes retrieved in comparison to the group randomized to GONAL-f®/Pergoveris®||0.59|-3.15|
74094288|NCT00140426|147739518|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.55|TWO_SIDED|95.0|0.41|1.74|||Regression, Cox|Time to reaching ease of eating level 3 assessed using Cox regression as some patients did not reach it during the study.|The hazard ratio is for the placebo group versus the treatment group. A hazard ratio \<1 implies that the placebo group had a lower risk of achieving EOE level 3, although not statistically significant. Achieving EOE level 3 was the desired endpoint.|||1.74|0.41|0.55
74094289|NCT00140426|147739522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.38|STANDARD_DEVIATION|3.74||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
74094290|NCT00140426|147739522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.45|STANDARD_DEVIATION|20.88|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
74042625|NCT01068717|147636996|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||TWO_SIDED|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||106.91|97.96|
74094291|NCT00140426|147739524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.26||0.47|TWO_SIDED|95.0|-0.71|0.33|||t-test, 2 sided||The mean difference was for placebo - risperidone.|Null hypothesis: no difference in change from baseline to end of treatment for CAPT total score||0.33|-0.71|0.47
74094292|NCT00140426|147739525|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
74094293|NCT00140426|147739526|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
74094294|NCT00140426|147739527|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
74094295|NCT00140426|147739528|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
74094296|NCT02149108|147739529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.49|0.69||Hazard ratio, confidence interval and p-value obtained from log-rank test stratified by regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio \<1 favors Nintedanib.|||0.69|0.49|<0.0001
74094297|NCT02149108|147739530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.8659|TWO_SIDED|95.0|0.86|1.19||Hazard ratio, confidence interval and p-value obtained from log-rank test stratified by regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio below 1 favors Nintedanib.|||1.19|0.86|0.8659
74094298|NCT02149108|147739532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|2.0|4.47||Odds ratio and p-value are obtained from logistic regression model adjusted for regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomization in the trial (less than 24 months vs. 24 months or more) and region.|Regression, Logistic||An odds ratio \>1 indicates benefit to Nintedanib.|||4.47|2.00|<0.0001
74094299|NCT01971970|147739562|EQUIVALENCE|The number of genes with a 1.5 fold change (FDR value ≤ 0.05; paired t-test) from week 0 to week 8 were assessed for pediatric IBD or adult IBD patients.|||||<|0.05|||||||Paired t-test,FDR 1.5fold,FDRvalue≤ 0.05|||The number of genes with a 1.5 fold change (FDR value ≤ 0.05; paired t-test) from week 0 to week 8 were assessed for pediatric IBD or adult IBD patients.||||< 0.05
74094300|NCT01971970|147739563|OTHER|||||||0.2616||||||Kaplan-Meier curve comparing the percentage of children and adults on continued anti-TNF therapy over the course of study duration|gehan-breslow-wilcoxon test|||Kaplan-Meier curves were produced by dividing the population in the following groups i) paediatric versus adult patients.These groups were used to statistically compare the proportions of patients over time regarding continued anti-TNF therapy, reflecting maintenance of response at 12 and 18 months.||||0.2616
74094301|NCT01971970|147739564|OTHER|||||||0.0177||||||Kaplan-Meier curve comparing the percentage of children and adults with therapy intensification over the course of study duration|gehan-breslow-wilcoxon test|||Kaplan-Meier curves were produced by dividing the population in the following groups i) paediatric versus adult patients.These groups were used to statistically compare the proportions of patients over time regarding the escalation of anti-TNF therapy (dose increase above 5 mg/kg and/or interval shortening to less than 8 weeks)||||0.0177
74094302|NCT04561375|147739645|SUPERIORITY||Proportional odds ratio|0.37||||0.067|TWO_SIDED|95.0|0.13|1.07|||proportional odds logistic regression|In the analysis, 100 µg and 150 µg were merged as one level since too few cases used 150 µg.||||1.07|0.13|0.067
74094303|NCT04561375|147739646|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.147|TWO_SIDED|97.5|-5.8|26.0|||Regression, Linear|||||26|-5.8|0.147
74094304|NCT04561375|147739647|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.463|TWO_SIDED|97.5|-18.0|34.0|||Regression, Linear|||||34|-18|0.463
74094305|NCT04561375|147739648|SUPERIORITY||Median Difference (Final Values)|-13.0||||0.032|TWO_SIDED|95.0|-25.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|-25|0.032
74012915|NCT03099187|147575990|SUPERIORITY||Hodges-Lehmann Median Difference|0.27||||0.2019|TWO_SIDED|95.0|-0.48|1.02||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||1.02|-0.48|0.2019
74012916|NCT03099187|147575991|SUPERIORITY||Hodges-Lehmann Median Difference|-2.0||||0.2995|TWO_SIDED|95.0|-10.0|4.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||4.00|-10.00|0.2995
74012917|NCT03099187|147575991|SUPERIORITY||Hodges-Lehmann Median Difference|-2.0||||0.3372|TWO_SIDED|95.0|-10.0|4.0||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||4.00|-10.00|0.3372
74012918|NCT03099187|147575992|SUPERIORITY||Hodges-Lehmann Median Difference|-1.86||||0.163|TWO_SIDED|95.0|-5.06|1.38|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||1.38|-5.06|0.1630
74012919|NCT03099187|147575992|SUPERIORITY||Hodges-Lehmann Median Difference|-1.74||||0.1851|TWO_SIDED|95.0|-5.0|1.55||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||1.55|-5.00|0.1851
74012920|NCT03099187|147575993|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.5922|TWO_SIDED|95.0|0.59|2.49|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Primary Analysis in 2019. All-cause non-elective hospitalization.||2.49|0.59|0.5922
74042626|NCT01068717|147636996|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|101.82|||||TWO_SIDED|90.0|96.1|107.88||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||107.88|96.10|
74042627|NCT01068717|147636997|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|102.64|||||TWO_SIDED|90.0|98.31|107.16||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||107.16|98.31|
74012921|NCT03099187|147575993|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.8057|TWO_SIDED|95.0|0.26|2.83|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Primary Analysis in 2019. Respiratory non-elective hospitalization.||2.83|0.26|0.8057
74094306|NCT02992418|147739652|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMCs between groups (Group 1/ Group 2) was greater than (\>) 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|0.848|||||TWO_SIDED|95.0|0.721|0.997||||||Anti-PT||0.997|0.721|
74012922|NCT03099187|147575993|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.4613|TWO_SIDED|95.0|0.63|2.73|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models|Final Analysis in 2020. All-cause non-elective hospitalization.||2.73|0.63|0.4613
74012923|NCT03099187|147575993|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9523|TWO_SIDED|95.0|0.3|3.59|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Final Analysis in 2020. Respiratory non-elective hospitalization.||3.59|0.30|0.9523
74012924|NCT03099187|147575995|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.7871|TWO_SIDED|95.0|0.26|2.78|||Log Rank|||||2.78|0.26|0.7871
74012925|NCT03099187|147575996|SUPERIORITY||Cox Proportional Hazard|0.84||||0.366|TWO_SIDED|95.0|0.56|1.24|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Primary Analysis in 2019||1.24|0.56|0.3660
74012926|NCT03099187|147575996|SUPERIORITY||Cox Proportional Hazard|0.85||||0.4173|TWO_SIDED|95.0|0.57|1.26|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Final Analysis in 2020||1.26|0.57|0.4173
74012927|NCT03099187|147575997|SUPERIORITY||Cox Proportional Hazard|0.79||||0.2726|TWO_SIDED|95.0|0.52|1.2|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Primary Analysis in 2019||1.20|0.52|0.2726
74012928|NCT03099187|147575997|SUPERIORITY||Cox Proportional Hazard|0.82||||0.3386|TWO_SIDED|95.0|0.54|1.24|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Final Analysis in 2020||1.24|0.54|0.3386
74012929|NCT03099187|147575998|SUPERIORITY||Cox Proportional Hazard|1.01||||0.9969|TWO_SIDED|95.0|0.06|16.08|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||||16.08|0.06|0.9969
74012930|NCT03099187|147575999|SUPERIORITY|||||||0.3231|||||||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||||||0.3231
74012931|NCT05248295|147576005|OTHER|Separate regression models were used within each group (People with aphasia and Controls) to independently assess the effects of the variables. Below, the results are reported for the effect of production condition (Unison vs. Solo) for the group of interest, People with aphasia.|Odds Ratio (OR)|1.21|STANDARD_ERROR_OF_MEAN|0.13||0.077|TWO_SIDED|||||Results are reported for production condition for people with aphasia (experimental group).|Regression, Logistic||OR computed with Unison as the numerator and Solo as the denominator|People with aphasia (PWA) were not directly compared to controls since the finding of a lower % syllables correct in any condition in PWA would be trivial. Instead, within-groups analyses were conducted to understand how the experimental variables affected syllable accuracy within each group.||||0.077
74012932|NCT05248295|147576005|OTHER|Below, the results are reported for the effect of timing condition (Metrical vs. Conversational) for the group of interest, People with aphasia.|||||>|0.1||||||Results are reported for Timing Condition for the People with aphasia.|Regression, Logistic|||||||>.1
74012933|NCT05248295|147576005|OTHER|Below, the results are reported for the interaction effect between production condition and timing condition for the group of interest, People with aphasia.|Odds Ratio (OR)|1.55|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED||||||Regression, Logistic||OR computed as ((Unison Metrical)/(Unison Conversational)) / ((Solo Metrical)/(Solo Conversational))|||||<0.001
74012934|NCT05248295|147576005|OTHER||Odds Ratio (OR)|0.63|STANDARD_ERROR_OF_MEAN|0.14||0.036|TWO_SIDED|||||Results are reported for Production Condition for the Control group.|Regression, Logistic||OR computed with Unison as the numerator and Solo as the denominator|Separate regression models were used within each group. Here, the results are reported for the Control group.||||0.036
74012935|NCT05248295|147576005|OTHER|Below, the results are reported for the effect of timing condition (Metrical vs. Conversational) for the control group.|Odds Ratio (OR)|3.36|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED||||||Regression, Logistic||OR computed with Metrical as the numerator and Conversational as the denominator|||||<0.001
74012936|NCT05248295|147576005|OTHER|Below, the results are reported for the interaction effect between production condition and timing condition for the control group.|||||>|0.1|||||||Regression, Logistic|||||||>.1
74012937|NCT05248295|147576006|OTHER|Separate regression models were used within each group (People with aphasia and Controls) to independently assess the effects of Timing Condition. Production Condition is not included in the analysis since all timing data are from the unison production condition, by definition.|Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||Results are reported for people with aphasia (experimental group).|Regression, Linear|||People with aphasia were not directly compared to Controls since the Control group is a context-providing reference group rather than a true comparator. Instead, within-groups analyses were conducted to understand how the experimental variable affected timing alignment in each group.||||<0.001
74042628|NCT01068717|147636997|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|99.22||||||90.0|96.48|102.04||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||102.04|96.48|
74094307|NCT02992418|147739652|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.892|1.18||||||Anti-FHA||1.18|0.892|
74094308|NCT02992418|147739652|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.11|||||TWO_SIDED|95.0|0.836|1.46||||||Anti-PRN||1.46|0.836|
74094309|NCT02992418|147739652|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.05|||||TWO_SIDED|95.0|0.827|1.33||||||Anti-FIM2+3||1.33|0.827|
74094310|NCT02992418|147739653|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was \> -10% for all antigens.|Percentage difference|0.26|||||TWO_SIDED|95.0|-4.53|5.04||||||Anti-D||5.04|-4.53|
74094311|NCT02992418|147739653|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was \> -10% for all antigens.|Percentage difference|-0.66|||||TWO_SIDED|95.0|-2.87|1.37||||||Anti-T||1.37|-2.87|
74012938|NCT05248295|147576006|OTHER||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|||||Results are reported for the Control group.|Regression, Linear|||People with aphasia were not directly compared to Controls since the Control group is a context-providing reference group and not a true comparator. Instead, within-groups analyses were conducted to understand how experimental variables affected timing alignment in each group.||||<0.001
74012939|NCT02958007|147576009|SUPERIORITY|||||||0.544|||||||t-test, 2 sided|||||||0.544
74012940|NCT03021499|147576010|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.001|TWO_SIDED|95.0|1.64|4.27|||Regression, Logistic|The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and Region.||The primary endpoint was the proportion of subjects showing renal response at Week 52 as adjudicated by the Clinical Endpoints Committee.||4.27|1.64|<0.001
74012941|NCT03021499|147576011|SUPERIORITY||Hazard Ratio (HR)|2.02|||<|0.001|TWO_SIDED|95.0|1.51|2.7|||Log Rank|||||2.7|1.51|<0.001
74012942|NCT03021499|147576013|SUPERIORITY||Odds Ratio (OR)|2.23||||0.002|TWO_SIDED|95.0|1.34|3.72|||Regression, Cox||The hazard ratios are from a Cox's proportional hazards model with terms for treatment arm, baseline UPCR, biopsy class, MMF use at baseline and Region|||3.72|1.34|0.002
73879821|NCT03192176|147297616|SUPERIORITY||LSMean difference|14.9|STANDARD_ERROR_OF_MEAN|6.84||0.0303|TWO_SIDED|95.0|1.42|28.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||28.32|1.42|0.0303
73879822|NCT03192176|147297616|SUPERIORITY||LSMean difference|19.6|STANDARD_ERROR_OF_MEAN|6.75||0.004|TWO_SIDED|95.0|6.3|32.87||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||32.87|6.30|0.0040
73879823|NCT03192176|147297616|SUPERIORITY||LSMean difference|19.5|STANDARD_ERROR_OF_MEAN|6.71||0.0038|TWO_SIDED|95.0|6.34|32.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||32.73|6.34|0.0038
73879824|NCT03192176|147297616|SUPERIORITY||LSMean difference|16.0|STANDARD_ERROR_OF_MEAN|6.45||0.0137|TWO_SIDED|95.0|3.29|28.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||28.68|3.29|0.0137
73879825|NCT03192176|147297616|SUPERIORITY||LSMean difference|18.1|STANDARD_ERROR_OF_MEAN|6.45||0.0052|TWO_SIDED|95.0|5.44|30.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||30.82|5.44|0.0052
73879826|NCT03192176|147297616|SUPERIORITY||LSMean difference|22.6|STANDARD_ERROR_OF_MEAN|6.5||0.0006|TWO_SIDED|95.0|9.81|35.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||35.39|9.81|0.0006
74012943|NCT03021499|147576014|SUPERIORITY||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.56|3.79||Week 24|Regression, Logistic||Week 24|Week 24||3.79|1.56|<0.001
74012944|NCT03021499|147576014|SUPERIORITY||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.45|3.51||Week 52|Regression, Logistic||Week 52|Week 52||3.51|1.45|<0.001
74012945|NCT03021499|147576015|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.349|TWO_SIDED|95.0|0.53|1.25|||Regression, Cox|||||1.25|0.53|0.349
74012946|NCT03021499|147576015|SUPERIORITY|||||||0.646|||||||Log Rank|||||||0.646
74012947|NCT03021499|147576018|SUPERIORITY||Hazard Ratio (HR)|2.05|||<|0.001|TWO_SIDED|95.0|1.62|2.6|||Log Rank|||||2.6|1.62|<0.001
73879827|NCT03192176|147297616|SUPERIORITY||LSMean difference|29.4|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|16.41|42.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||42.32|16.41|<0.0001
73879828|NCT03192176|147297616|SUPERIORITY||LSMean difference|13.7|STANDARD_ERROR_OF_MEAN|6.57||0.0378|TWO_SIDED|95.0|0.78|26.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||26.63|0.78|0.0378
73879829|NCT03192176|147297616|SUPERIORITY||LSMean difference|20.1|STANDARD_ERROR_OF_MEAN|6.49||0.002|TWO_SIDED|95.0|7.31|32.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||32.85|7.31|0.002
74012948|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-4.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||Mixed Models Analysis|||Week 2||-1.9|-7.3|< 0.001
74012949|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-3.4|STANDARD_ERROR_OF_MEAN|1.39||0.014|TWO_SIDED|95.0|-6.1|-0.7|||Mixed Models Analysis|||Week 4||-0.7|-6.1|0.014
74012950|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-4.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||Mixed Models Analysis|||Week 8||-1.9|-7.3|< 0.001
74012951|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-3.3|STANDARD_ERROR_OF_MEAN|1.39||0.017|TWO_SIDED|95.0|-6.0|-0.6|||Mixed Models Analysis|||Week 12||-0.6|-6|0.017
74012952|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-2.4|STANDARD_ERROR_OF_MEAN|1.4||0.085|TWO_SIDED|95.0|-5.1|0.3|||Mixed Models Analysis|||Week 16||0.3|-5.1|0.085
74012953|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.035|TWO_SIDED|95.0|-5.7|-0.2|||Mixed Models Analysis|||Week 20||-0.2|-5.7|0.035
74012954|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-2.2|STANDARD_ERROR_OF_MEAN|1.41||0.121|TWO_SIDED|95.0|-5.0|0.6|||Mixed Models Analysis|||Week 24||0.6|-5|0.121
74012955|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-2.2|STANDARD_ERROR_OF_MEAN|1.42||0.12|TWO_SIDED|95.0|-5.0|0.6|||Mixed Models Analysis|||Week 30||0.6|-5|0.12
74012956|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-2.3|STANDARD_ERROR_OF_MEAN|1.43||0.102|TWO_SIDED|95.0|-5.1|0.5|||Mixed Models Analysis|||Week 36||0.5|-5.1|0.102
74012957|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-3.3|STANDARD_ERROR_OF_MEAN|1.44||0.022|TWO_SIDED|95.0|-6.1|0.5|||Mixed Models Analysis|||Week 42||0.5|-6.1|0.022
74012958|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-4.1|STANDARD_ERROR_OF_MEAN|1.45||0.004|TWO_SIDED|95.0|-7.0|-1.3|||Mixed Models Analysis|||Week 48||-1.3|-7|0.004
74012959|NCT03021499|147576019|SUPERIORITY||Mean Difference (Least Squares)|-2.8|STANDARD_ERROR_OF_MEAN|1.46||0.055|TWO_SIDED|95.0|-5.7|0.1|||Mixed Models Analysis|||Week 52||0.1|-5.7|0.055
74012960|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-0.56|STANDARD_ERROR_OF_MEAN|0.181||0.011|TWO_SIDED|95.0|-1.0|-0.13|||Mixed Models Analysis|||Week 2||-0.13|-1|0.011
74012961|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-0.76|STANDARD_ERROR_OF_MEAN|0.187|<|0.001|TWO_SIDED|95.0|-1.13|-0.4|||Mixed Models Analysis|||Week 4||-0.4|-1.13|<0.001
74012962|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-0.7|STANDARD_ERROR_OF_MEAN|0.181|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||Mixed Models Analysis|||Week 8||-0.34|-1.05|<0.001
74012963|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-0.94|STANDARD_ERROR_OF_MEAN|0.196|<|0.001|TWO_SIDED|95.0|-1.33|-0.55|||Mixed Models Analysis|||Week 12||-0.55|-1.33|<0.001
74012964|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-1.18|STANDARD_ERROR_OF_MEAN|0.214|<|0.001|TWO_SIDED|95.0|-1.6|-0.76|||Mixed Models Analysis|||Week 16||-0.76|-1.6|<0.001
74042629|NCT01068717|147636998|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.04|||||TWO_SIDED|95.0|92.9|105.59||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||105.59|92.90|
74042630|NCT01068717|147636998|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.77|||||TWO_SIDED|95.0|96.82|109.09||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||109.09|96.82|
74012965|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-1.16|STANDARD_ERROR_OF_MEAN|0.241|<|0.001|TWO_SIDED|95.0|-1.63|-0.68|||Mixed Models Analysis|||Week 20||-0.68|-1.63|<0.001
74042631|NCT02758119|147637007|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74042632|NCT00719862|147637012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_DEVIATION|0.3782||0.005||95.0|-1.8|-0.31|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.31|-1.80|0.005
74042633|NCT00719862|147637013|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.2987|STANDARD_DEVIATION|0.1881||0.112||95.0|-0.67|0.07|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.07|-0.67|0.112
74042634|NCT00719862|147637014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8617|STANDARD_DEVIATION|0.3803||0.023||95.0|-1.61|-0.12|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.12|-1.61|0.023
74042635|NCT00719862|147637015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7395|STANDARD_DEVIATION|0.3305||0.025||95.0|-1.39|-0.09|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline||-0.09|-1.39|0.025
74042636|NCT00719862|147637016|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANOVA|||Change from baseline||||0.051
74042637|NCT01060098|147637018|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.003
74042638|NCT01060098|147637018|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.04
74012966|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-1.15|STANDARD_ERROR_OF_MEAN|0.222|<|0.001|TWO_SIDED|95.0|-1.59|-0.72|||Mixed Models Analysis|||Week 24||-0.72|-1.59|<0.001
74012967|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-1.02|STANDARD_ERROR_OF_MEAN|0.284|<|0.001|TWO_SIDED|95.0|-1.58|-0.46|||Mixed Models Analysis|||Week 30||-0.46|-1.58|<0.001
74012968|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-1.21|STANDARD_ERROR_OF_MEAN|0.264|<|0.001|TWO_SIDED|95.0|-1.73|-0.69|||Mixed Models Analysis|||Week 36||-0.69|-1.73|<0.001
74012969|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-1.37|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-1.87|-0.86|||Mixed Models Analysis|||Week 42||-0.86|-1.87|<0.001
74012970|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-1.06|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-1.56|-0.55|||Mixed Models Analysis|||Week 48||-0.55|-1.56|<0.001
74012971|NCT03021499|147576020|SUPERIORITY||Mean Difference (Least Squares)|-0.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.52|-0.46|||Mixed Models Analysis|||Week 52||-0.46|-1.52|<0.001
74012972|NCT03021499|147576021|SUPERIORITY||Odds Ratio (OR)|2.44||||0.008|TWO_SIDED|95.0|1.26|4.71||Week 24|Regression, Logistic||Week 24|Week 24||4.71|1.26|0.008
74012973|NCT03021499|147576021|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.48|4.0||Week 52|Regression, Logistic||Week 52|Week 52||4.00|1.48|<0.001
74012974|NCT03021499|147576022|SUPERIORITY||Least Squares Mean difference|-0.5||||0.373|TWO_SIDED|95.0|-1.6|0.6||Week 24|Mixed Models Analysis||Week 24|Week 24||0.6|-1.6|0.373
74012975|NCT03021499|147576022|SUPERIORITY||Least Squares Mean difference|-0.5||||0.277|TWO_SIDED|95.0|-1.4|0.4||Week 52|Mixed Models Analysis||Week 52|Week 52||0.4|-1.4|0.277
74012976|NCT03021499|147576023|SUPERIORITY||Slope|-0.47|STANDARD_ERROR_OF_MEAN|1.389||0.733|TWO_SIDED|95.0|-3.21|2.26|||Mixed Models Analysis|||SF-36 Change from Baseline Week 24||2.26|-3.21|0.733
74012977|NCT03021499|147576023|SUPERIORITY||Mean Difference (Least Squares)|-0.37|STANDARD_ERROR_OF_MEAN|1.481||0.801|TWO_SIDED|95.0|-3.29|2.54|||Mixed Models Analysis|||SF-36 Change from Baseline at Week 52||2.54|-3.29|0.801
73879830|NCT03192176|147297616|SUPERIORITY||LSMean difference|17.4|STANDARD_ERROR_OF_MEAN|6.44||0.0071|TWO_SIDED|95.0|4.77|30.09||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||30.09|4.77|0.0071
73879831|NCT03192176|147297616|SUPERIORITY||LSMean difference|20.7|STANDARD_ERROR_OF_MEAN|6.63||0.002|TWO_SIDED|95.0|7.61|33.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||33.71|7.61|0.0020
73879832|NCT03192176|147297616|SUPERIORITY||LSMean difference|18.7|STANDARD_ERROR_OF_MEAN|6.63||0.005|TWO_SIDED|95.0|5.68|31.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||31.79|5.68|0.0050
73879833|NCT03192176|147297616|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.71||0.0003|TWO_SIDED|95.0|11.2|37.6||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||37.60|11.20|0.0003
73879834|NCT03192176|147297616|SUPERIORITY||LSMean difference|32.1|STANDARD_ERROR_OF_MEAN|6.77|<|0.0001|TWO_SIDED|95.0|18.77|45.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||45.42|18.77|<0.0001
74042639|NCT01060098|147637018|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.48
74042640|NCT00107172|147637023|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.01||||0.98|TWO_SIDED|95.0|0.51|1.98|||Log Rank|Competing risk P-value = 0.91.||The competing risk analysis accounting for death/regional and distant recurrence as competing events was performed.||1.98|0.51|0.98
74042641|NCT00107172|147637024|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.07||||0.75|TWO_SIDED|95.0|0.71|1.61|||Log Rank|||||1.61|0.71|0.75
74042642|NCT00107172|147637029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 30 between arms.||||0.37
74042643|NCT00107172|147637029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 90 between arms.||||0.25
74042644|NCT00107172|147637030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 30 between arms.||||0.35
73879835|NCT03192176|147297616|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|6.76||0.005|TWO_SIDED|95.0|5.79|32.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Wek 10||32.38|5.79|0.0050
73879836|NCT03192176|147297616|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|6.68||0.0006|TWO_SIDED|95.0|9.95|36.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||36.22|9.95|0.0006
73879837|NCT03192176|147297616|SUPERIORITY||LSMean difference|22.8|STANDARD_ERROR_OF_MEAN|6.62||0.0006|TWO_SIDED|95.0|9.79|35.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||35.85|9.79|0.0006
74012978|NCT03021499|147576023|SUPERIORITY||Mean Difference (Least Squares)|1.7|STANDARD_ERROR_OF_MEAN|1.442||0.239|TWO_SIDED|95.0|-1.14|4.54|||Mixed Models Analysis|||LupusPRO HRQOL Change from Baseline at Week 24||4.54|-1.14|0.239
74012979|NCT03021499|147576023|SUPERIORITY||Mean Difference (Least Squares)|-0.6|STANDARD_ERROR_OF_MEAN|1.535||0.695|TWO_SIDED|95.0|-3.62|2.42|||Mixed Models Analysis|||LupusPRO HRQOL Change from Baseline at Week 52||2.42|-3.62|0.695
74012980|NCT03021499|147576023|SUPERIORITY||Mean Difference (Least Squares)|-1.89|STANDARD_ERROR_OF_MEAN|1.439||0.19|TWO_SIDED|95.0|-4.72|0.94|||Mixed Models Analysis|||LupusPRO non-HRQOL Change from Baseline at Week 24||0.94|-4.72|0.19
74012981|NCT03021499|147576023|SUPERIORITY||Mean Difference (Least Squares)|0.826|STANDARD_ERROR_OF_MEAN|1.531||0.826|TWO_SIDED|95.0|-2.67|3.35|||Mixed Models Analysis|||LupusPRO non-HRQOL Change from Baseline at Week 52||3.35|-2.67|0.826
74012982|NCT04869345|147576063|SUPERIORITY||Odds Ratio (OR)|0.67||||0.684|TWO_SIDED|95.0|0.13|3.05||A priori threshold for statistical significance = 0.05.|Boschloo Test||Maximum likelihood estimate of the Odds Ratio comparing retention rate in LARKSPUR group to Attention Control group|||3.05|0.13|.684
74042645|NCT00107172|147637030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 90 between arms.||||0.31
74042646|NCT00107172|147637033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.||||0.03
73879838|NCT03192176|147297616|SUPERIORITY||LSMean difference|18.5|STANDARD_ERROR_OF_MEAN|6.32||0.0036|TWO_SIDED|95.0|6.11|30.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||30.98|6.11|0.0036
73879839|NCT03192176|147297616|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|6.32||0.0015|TWO_SIDED|95.0|7.77|32.65||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||32.65|7.77|0.0015
73879840|NCT03192176|147297616|SUPERIORITY||LSMean difference|25.0|STANDARD_ERROR_OF_MEAN|6.39||0.0001|TWO_SIDED|95.0|12.41|37.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||37.57|12.41|0.0001
74012983|NCT04869345|147576066|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.28||0.835|TWO_SIDED|95.0|-2.8|2.27||The threshold for statistical significance was 0.05.|Mixed Models Analysis|P-value adjusted using the Kenward-Roger (1997) degrees of freedom method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.27|-2.80|0.835
74042647|NCT00107172|147637033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.||||0.18
74042648|NCT00107172|147637034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.||||0.38
74042649|NCT00107172|147637034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.||||0.16
74042650|NCT02688153|147637035|SUPERIORITY||Median Difference (Final Values)|-4.5||||0.366|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3660
74042651|NCT02688153|147637036|SUPERIORITY||Median Difference (Final Values)|2.0||||0.8377|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8377
74042652|NCT01135394|147637109|OTHER|The genes with p-values below 10\^-6 were identified|Pearson correlation p-value|0.0000001|||<|1e-07|TWO_SIDED|||||The genes with p-values below 10\^-6 were identified|Genes with p-values below 10^-6|||After the change (end-of-treatment minus baseline) in HOMA-IR index had been calculated for each subject, the change (end-of-treatment minus baseline) in expression of each of approximately 45,000 transcripts contained in a human gene array was calculated. A Pearson correlation p-value was calculated for the correlation between change in gene expression and change in HOMA-IR index, with the purpose of identifying the genes whose expression changed in concert with changes in HOMA-IR index.|The genes with P-values below 10\^-6 were identified|||<0.0000001
74042653|NCT00191386|147637112|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 6 Months|Paired t-test|||||||<0.001
74042654|NCT00191386|147637112|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 12 Months|Paired t-test|||||||<0.001
74042655|NCT00191386|147637112|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 2 Years.|Paired t-test|||||||<0.001
74042656|NCT00191386|147637112|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 3 Years.|Paired t-test|||||||<0.001
74042657|NCT00191386|147637112|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 4 Years.|Paired t-test|||||||<0.001
74042658|NCT00191386|147637113|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 6 Months.|Paired t-test|||||||<0.001
74042659|NCT00191386|147637113|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 12 Months.|Paired t-test|||||||<0.001
74094312|NCT02992418|147739654|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.862|1.44||||||Serotype 1||1.44|0.862|
73879841|NCT03192176|147297616|SUPERIORITY||LSMean difference|29.8|STANDARD_ERROR_OF_MEAN|6.45|<|0.0001|TWO_SIDED|95.0|17.12|42.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||42.49|17.12|<0.0001
73879842|NCT03192176|147297616|SUPERIORITY||LSMean difference|19.6|STANDARD_ERROR_OF_MEAN|6.43||0.0026|TWO_SIDED|95.0|6.9|32.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||32.21|6.90|0.0026
74042660|NCT00191386|147637113|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 2 Years.|Paired t-test|||||||<0.001
74042661|NCT00191386|147637113|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 3 Years.|Paired t-test|||||||<0.001
74042662|NCT00191386|147637113|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 4 Years.|Paired t-test|||||||<0.001
74042663|NCT02061748|147637129|SUPERIORITY_OR_OTHER|||||||0.0111|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0111
74042664|NCT02061748|147637130|SUPERIORITY_OR_OTHER|||||||0.0861|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0861
74042665|NCT02061748|147637131|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0011
74042666|NCT02061748|147637132|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0019
74042667|NCT02061748|147637133|SUPERIORITY_OR_OTHER|||||||0.0808|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0808
74094313|NCT02992418|147739654|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|1.19|||||TWO_SIDED|95.0|0.97|1.47||||||Serotype 2||1.47|0.97|
74094314|NCT02992418|147739654|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.925|||||TWO_SIDED|95.0|0.739|1.16||||||Serotype 3||1.16|0.739|
74094315|NCT02992418|147739654|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.802|||||TWO_SIDED|95.0|0.644|0.999||||||Serotype 4||0.999|0.644|
74012984|NCT04869345|147576066|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.29||0.732|TWO_SIDED|95.0|-2.12|3.0||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.00|-2.12|0.732
74012985|NCT04869345|147576066|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|1.38||0.609|TWO_SIDED|95.0|-2.05|3.47||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.47|-2.05|0.609
74012986|NCT04869345|147576067|SUPERIORITY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|1.08||0.445|TWO_SIDED|95.0|-2.97|1.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||1.31|-2.97|0.445
74012987|NCT04869345|147576067|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|1.09||0.209|TWO_SIDED|95.0|-0.78|3.54||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.54|-0.78|0.209
74012988|NCT04869345|147576067|SUPERIORITY||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|1.17||0.063|TWO_SIDED|95.0|-0.12|4.54||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||4.54|-0.12|0.063
74042668|NCT02061748|147637134|SUPERIORITY_OR_OTHER|||||||0.3502|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.3502
74042669|NCT02061748|147637135|SUPERIORITY_OR_OTHER|||||||0.0068|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0068
74042670|NCT02061748|147637136|SUPERIORITY_OR_OTHER|||||||0.0271|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0271
74094316|NCT01992523|147739692|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%). Data were compared by means of the chi-2 test or Fisher exact test for categorical variables and unpaired t test or Mann-Whitney U-test for continuous variables, as appropriate. A P value \< .05 was considered statistically significant. All tests were two-sided.||||0.006
74094317|NCT04536935|147739696|SUPERIORITY|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the PHQ-9 and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.|Slope|-1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.8|-1.1|||Mixed Models Analysis|||||-1.1|-1.8|<.001
73879843|NCT03192176|147297616|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|6.36||0.0003|TWO_SIDED|95.0|10.92|35.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||35.94|10.92|0.0003
73879844|NCT03192176|147297616|SUPERIORITY||LSMean difference|21.7|STANDARD_ERROR_OF_MEAN|6.3||0.0006|TWO_SIDED|95.0|9.34|34.14||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||34.14|9.34|0.0006
74012989|NCT04869345|147576068|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.95||0.792|TWO_SIDED|95.0|-1.63|2.13||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.13|-1.63|0.792
74012990|NCT04869345|147576068|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.95||0.209|TWO_SIDED|95.0|-0.69|3.09||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.09|-0.69|0.209
74012991|NCT04869345|147576068|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.66||0.151|TWO_SIDED|95.0|-0.35|2.26||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.26|-0.35|0.151
74012992|NCT04869345|147576069|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.47||0.601|TWO_SIDED|95.0|-2.14|3.69||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.69|-2.14|0.601
74012993|NCT04869345|147576069|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|1.49||0.269|TWO_SIDED|95.0|-4.6|1.29||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||1.29|-4.60|0.269
74094318|NCT04536935|147739697|OTHER|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the GAD-7 and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.|Slope|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.6|-1.0|||Mixed Models Analysis|||||-1.0|-1.6|<.001
74042671|NCT02061748|147637137|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0749
74042672|NCT02061748|147637138|SUPERIORITY_OR_OTHER|||||||0.0072|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0072
74042673|NCT02061748|147637139|SUPERIORITY_OR_OTHER|||||||0.0055|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0055
74012994|NCT04869345|147576069|SUPERIORITY||Mean Difference (Net)|-2.43|STANDARD_ERROR_OF_MEAN|1.53||0.116|TWO_SIDED|95.0|-5.47|0.61||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.61|-5.47|0.116
74012995|NCT04869345|147576070|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.08||0.479|TWO_SIDED|95.0|-0.1|0.22||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.22|-0.10|0.479
74012996|NCT04869345|147576070|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.08||0.126|TWO_SIDED|95.0|-0.04|0.29||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.29|-0.04|0.126
74012997|NCT04869345|147576070|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.457|TWO_SIDED|95.0|-0.12|0.25||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.25|-0.12|0.457
74012998|NCT04869345|147576071|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.389|TWO_SIDED|95.0|-0.15|0.38||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.38|-0.15|0.389
74012999|NCT04869345|147576071|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.13||0.157|TWO_SIDED|95.0|-0.07|0.46||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.46|-0.07|0.157
74013000|NCT04869345|147576071|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.593|TWO_SIDED|95.0|-0.21|0.36||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.36|-0.21|0.593
74013001|NCT04869345|147576072|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.933|TWO_SIDED|95.0|-0.26|0.24||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.24|-0.26|0.933
74094319|NCT04536935|147739698|OTHER|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the DERS and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.||||||0.73|||||||Mixed Models Analysis|||||||.73
74094320|NCT04536935|147739699|OTHER|||||||0.25|||||||Mixed Models Analysis|||||||.25
74094321|NCT04536935|147739700|SUPERIORITY|||||||0.22|||||||ANOVA|||||||.22
73879845|NCT03192176|147297616|SUPERIORITY||LSMean difference|19.3|STANDARD_ERROR_OF_MEAN|6.37||0.0026|TWO_SIDED|95.0|6.78|31.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||31.83|6.78|0.0026
74013002|NCT04869345|147576072|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.642|TWO_SIDED|95.0|-0.19|0.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.31|-0.19|0.642
74013003|NCT04869345|147576072|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.577|TWO_SIDED|95.0|-0.18|0.32||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.32|-0.18|0.577
74013004|NCT04869345|147576073|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.11||0.403|TWO_SIDED|95.0|-0.32|0.13||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.13|-0.32|0.403
74013005|NCT04869345|147576073|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.11||0.062|TWO_SIDED|95.0|-0.44|0.01||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.01|-0.44|0.062
74013006|NCT04869345|147576073|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.269|TWO_SIDED|95.0|-0.33|0.09||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.09|-0.33|0.269
74013007|NCT04869345|147576074|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|0.07|0.33||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.33|0.07|0.003
74013008|NCT04869345|147576074|SUPERIORITY||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.006|TWO_SIDED|95.0|0.05|0.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.31|0.05|0.006
73879846|NCT03192176|147297616|SUPERIORITY||LSMean difference|20.8|STANDARD_ERROR_OF_MEAN|6.36||0.0012|TWO_SIDED|95.0|8.29|33.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||33.33|8.29|0.0012
74042674|NCT02061748|147637140|SUPERIORITY_OR_OTHER|||||||0.0284|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0284
74042675|NCT02061748|147637141|SUPERIORITY_OR_OTHER|||||||0.907|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.907
74094322|NCT04536935|147739701|SUPERIORITY|||||||0.48|||||||ANOVA|||||||.48
73879847|NCT03192176|147297616|SUPERIORITY||LSMean difference|25.1|STANDARD_ERROR_OF_MEAN|6.44||0.0001|TWO_SIDED|95.0|12.48|37.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||37.82|12.48|0.0001
73879848|NCT03192176|147297616|SUPERIORITY||LSMean difference|31.9|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|19.11|44.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||44.67|19.11|<0.0001
74013009|NCT04869345|147576074|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.796|TWO_SIDED|95.0|-0.15|0.12||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.12|-0.15|0.796
73879849|NCT03192176|147297616|SUPERIORITY||LSMean difference|20.1|STANDARD_ERROR_OF_MEAN|6.48||0.0021|TWO_SIDED|95.0|7.32|32.81||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||32.81|7.32|0.0021
73879850|NCT03192176|147297616|SUPERIORITY||LSMean difference|22.7|STANDARD_ERROR_OF_MEAN|6.4||0.0004|TWO_SIDED|95.0|10.1|35.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||35.29|10.10|0.0004
73879851|NCT03192176|147297616|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.34||0.0006|TWO_SIDED|95.0|9.42|34.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||34.38|9.42|0.0006
73879852|NCT03192176|147297616|SUPERIORITY||LSMean difference|17.0|STANDARD_ERROR_OF_MEAN|7.82||0.0304|TWO_SIDED|95.0|1.62|32.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||32.40|1.62|0.0304
73879853|NCT03192176|147297616|SUPERIORITY||LSMean difference|6.8|STANDARD_ERROR_OF_MEAN|7.82||0.3857|TWO_SIDED|95.0|-8.6|22.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMMRM|||Week 13||22.19|-8.60|0.3857
73879854|NCT03192176|147297616|SUPERIORITY||LSMean difference|7.5|STANDARD_ERROR_OF_MEAN|8.06||0.3497|TWO_SIDED|95.0|-8.31|23.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||23.40|-8.31|0.3497
74013010|NCT04869345|147576075|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.758|TWO_SIDED|95.0|-0.03|0.05||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.05|-0.03|0.758
74094323|NCT04536935|147739702|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<.0001
73879855|NCT03192176|147297616|SUPERIORITY||LSMean difference|10.9|STANDARD_ERROR_OF_MEAN|8.05||0.1771|TWO_SIDED|95.0|-4.95|26.75||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|LSMean difference|||Week 13||26.75|-4.95|0.1771
74042676|NCT02061748|147637142|SUPERIORITY_OR_OTHER|||||||0.8208|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8208
74042677|NCT02061748|147637143|SUPERIORITY_OR_OTHER|||||||0.1534|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.1534
74042678|NCT02061748|147637144|SUPERIORITY_OR_OTHER|||||||0.3055|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.3055
74042679|NCT02061748|147637145|SUPERIORITY_OR_OTHER|||||||0.9573|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.9573
74094324|NCT02500641|147739735|SUPERIORITY|||||||0.5298|||||||ANCOVA|||||||0.5298
74094325|NCT00643565|147739769|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.7189|TWO_SIDED|95.0|0.61|1.41|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.||1.41|0.61|0.7189
74094326|NCT00643565|147739770|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3211|TWO_SIDED|95.0|0.51|1.25|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.||1.25|0.51|0.3211
73879856|NCT03192176|147297616|SUPERIORITY||LSMean difference|16.3|STANDARD_ERROR_OF_MEAN|8.1||0.0444|TWO_SIDED|95.0|0.41|32.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||32.29|0.41|0.0444
73879857|NCT03192176|147297616|SUPERIORITY||LSMean difference|11.7|STANDARD_ERROR_OF_MEAN|8.1||0.15|TWO_SIDED|95.0|-4.25|27.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||27.63|-4.25|0.1500
73879858|NCT03192176|147297616|SUPERIORITY||LSMean difference|3.9|STANDARD_ERROR_OF_MEAN|7.83||0.6196|TWO_SIDED|95.0|-11.51|19.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||19.29|-11.51|0.6196
73879859|NCT03192176|147297616|SUPERIORITY||LSMean difference|9.4|STANDARD_ERROR_OF_MEAN|8.48||0.2664|TWO_SIDED|95.0|-7.25|26.15||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||26.15|-7.25|0.2664
73879860|NCT03192176|147297616|SUPERIORITY||LSMean differencce|4.0|STANDARD_ERROR_OF_MEAN|8.44||0.6388|TWO_SIDED|95.0|-12.66|20.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||20.59|-12.66|0.6388
73879861|NCT03192176|147297616|SUPERIORITY||LSMean difference|4.9|STANDARD_ERROR_OF_MEAN|8.79||0.5797|TWO_SIDED|95.0|-12.43|22.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||22.19|-12.43|0.5797
73879862|NCT03192176|147297616|SUPERIORITY||LSMean difference|6.2|STANDARD_ERROR_OF_MEAN|8.78||0.4817|TWO_SIDED|95.0|-11.1|23.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||23.47|-11.10|0.4817
74013011|NCT04869345|147576075|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.88|TWO_SIDED|95.0|-0.04|0.04||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.04|-0.04|0.880
74013012|NCT04869345|147576075|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.652|TWO_SIDED|95.0|-0.05|0.03||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.03|-0.05|0.652
74013013|NCT02116777|147576119|OTHER|Maximum Tolerate Dose Level was determined by the rolling-6 design.|Maximum Tolerate Dose Level|4.0|||||TWO_SIDED||||||||Maximum Tolerate Dose Level is Dose Level 4 (600 mcg/m²/dose +30 mg/m2/dose (BMN 673) BID + 30 mg/m²/dose (TEM), Max 1000 mcg/day). MTD determined by using the Rolling-6 Design.|||||
74094327|NCT00759902|147739846|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|123.0||||||90.0|112.9|134.1|||ANOVA|log-transformation||||134.1|112.9|
74094328|NCT00759902|147739848|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|98.5|104.9|||ANOVA|log-transformation||||104.9|98.5|
73879863|NCT03192176|147297616|SUPERIORITY||LSMean differencce|10.5|STANDARD_ERROR_OF_MEAN|8.8||0.2358|TWO_SIDED|95.0|-6.87|27.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||27.79|-6.87|0.2358
74013014|NCT04673292|147576187|EQUIVALENCE|The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing community-based testing to the fixed site SOC testing.|Prevalence Ratio|1.04||||0.67|TWO_SIDED|95.0|0.86|1.27|||Poisson Regression|Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.|||Models were adjusted for employment.|1.27|0.86|0.67
74013015|NCT04673292|147576187|EQUIVALENCE|The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing self-collected testing to the fixed site SOC testing.|Prevalence Ratio|1.08||||0.43|TWO_SIDED|95.0|0.89|1.31|||Poisson Regression|Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.|||Models were adjusted for employment.|1.31|0.89|0.43
73879864|NCT03192176|147297616|SUPERIORITY||LSMean difference|14.3|STANDARD_ERROR_OF_MEAN|8.86||0.107|TWO_SIDED|95.0|-3.11|31.77||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||31.77|-3.11|0.1070
74013016|NCT04673292|147576188|EQUIVALENCE|Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the community-based testing to fixed site SOC testing. Alpha threshold of 0.05.|Time Ratio|0.87||||0.14|TWO_SIDED|95.0|0.73|1.05||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 30 days.|Models adjusted for employment|1.05|0.73|0.14
74013017|NCT04673292|147576188|EQUIVALENCE|Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the self-collected testing arm to the fixed site SOC testing Alpha threshold of 0.05.|Time Ratio|0.86||||0.09|TWO_SIDED|95.0|0.71|1.03||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 30 days.|Models adjusted for employment|1.03|0.71|0.09
74013018|NCT04673292|147576189|EQUIVALENCE|Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the community-based testing to fixed site SOC testing.|Time Ratio|0.96||||0.56|TWO_SIDED|95.0|0.83|1.1||aprior threshold for significance: p\<0.05|Accelerated Failure Time|Study arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 10 days.|Models adjusted for employment|1.10|0.83|0.56
74013019|NCT04673292|147576189|EQUIVALENCE|Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the self-collected testing arm to the fixed site SOC testing.|Time Ratio|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 10 days.|Models adjusted for employment|1.07|0.81|0.32
74013020|NCT03045861|147576218|OTHER||Emax|-1.822|||||TWO_SIDED|95.0|-2.333|1.31||||||||1.310|-2.333|
74013021|NCT03045861|147576218|OTHER||ED50|1020.755|||||TWO_SIDED|95.0|100.786|1940.724||||||||1940.724|100.786|
74042680|NCT02061748|147637146|SUPERIORITY_OR_OTHER|||||||0.8465|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8465
74042681|NCT02061748|147637147|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0006
74042682|NCT02061748|147637148|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||<0.0001
74013022|NCT03045861|147576218|OTHER||s2e|0.2|||||TWO_SIDED|95.0|0.095|0.306||||||||0.306|0.095|
74042683|NCT02061748|147637149|SUPERIORITY_OR_OTHER|||||||0.0185|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0185
74042684|NCT02061748|147637150|SUPERIORITY_OR_OTHER|||||||0.0138|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0138
74042685|NCT02061748|147637151|SUPERIORITY_OR_OTHER|||||||0.261|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.261
74094329|NCT00759902|147739849|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|102.9||||||90.0|99.3|106.5|||ANOVA|log-transformation||||106.5|99.3|
74094330|NCT05071313|147739870|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.14||||||A/Victoria||1.14|0.89|
74094331|NCT05071313|147739870|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.28||||||A/Tasmania||1.28|0.97|
74094332|NCT05071313|147739870|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|0.91|||||TWO_SIDED|95.0|0.79|1.05||||||B/Washington||1.05|0.79|
74094333|NCT05071313|147739870|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|0.97||||||95.0|0.85|1.1||||||B/Phuket||1.10|0.85|
74094334|NCT03107026|147739885|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.187||0.1187|TWO_SIDED|95.0|-0.66|0.08|||Mixed Models Analysis|||||0.08|-0.66|0.1187
74094335|NCT03107026|147739885|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.192||0.0045|TWO_SIDED|95.0|-0.93|-0.17|||Mixed Models Analysis|||||-0.17|-0.93|0.0045
74013023|NCT03045861|147576219|OTHER||Emax|-1.801|||||TWO_SIDED|95.0|-2.319|-1.283||||||||-1.283|-2.319|
74013024|NCT03045861|147576219|OTHER||ED50|55.572|||||TWO_SIDED|95.0|3.565|107.579||||||||107.579|3.565|
74013025|NCT03045861|147576219|OTHER||s2e|0.206|||||TWO_SIDED|95.0|0.097|0.314||||||||0.314|0.097|
74013026|NCT03045861|147576220|OTHER||Emax|-1.846|||||TWO_SIDED|95.0|-2.352|-1.34||||||||-1.340|-2.352|
73879865|NCT03192176|147297616|SUPERIORITY||LSMean difference|6.7|STANDARD_ERROR_OF_MEAN|8.47||0.4268|TWO_SIDED|95.0|-9.94|23.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||23.43|-9.94|0.4268
73879866|NCT03192176|147297616|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|8.61||0.9197|TWO_SIDED|95.0|-17.81|16.08||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||16.08|-17.81|0.9197
73879867|NCT03192176|147297616|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|8.54||0.9954|TWO_SIDED|95.0|-16.77|16.87||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||16.87|-16.77|0.9954
73879868|NCT03192176|147297616|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|9.0||0.9607|TWO_SIDED|95.0|-17.28|18.17||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||18.17|-17.28|0.9607
73879869|NCT03192176|147297616|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|8.87||0.6625|TWO_SIDED|95.0|-21.33|13.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.59|-21.33|0.6625
73879870|NCT03192176|147297616|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|9.01||0.9952|TWO_SIDED|95.0|-17.81|17.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||17.70|-17.81|0.9952
73879871|NCT03192176|147297616|SUPERIORITY||LSMean difference|7.6|STANDARD_ERROR_OF_MEAN|9.02||0.4001|TWO_SIDED|95.0|-10.16|25.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||25.36|-10.16|0.4001
73879872|NCT03192176|147297616|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|8.54||0.751|TWO_SIDED|95.0|-19.52|14.1||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||14.10|-19.52|0.7510
73879873|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|6.02||||0.0018|TWO_SIDED|95.0|1.95|18.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.64|1.95|0.0018
73879874|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|8.28||||0.0002|TWO_SIDED|95.0|2.7|25.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.42|2.70|0.0002
74013027|NCT03045861|147576220|OTHER||ED50|32.415|||||TWO_SIDED|95.0|4.687|60.143||||||||60.143|4.687|
74013028|NCT03045861|147576220|OTHER||s2e|0.2|||||TWO_SIDED|95.0|0.094|0.305||||||||0.305|0.094|
74013029|NCT01040351|147576284|NON_INFERIORITY_OR_EQUIVALENCE|. The aggregate result of 6 studies reporting the pregnancy rate of patients with ultrasound visible hydrosalpinx revealed that clinical pregnancy rate among the patients with ultrasound-visible hydrosalpinges was 12.6%. We assumed that the aspiration of hydrosalpinx could restore clinical pregnancy rate to that expected for patients with tubal factor of infertility but without hydrosalpinges (about 36.5% in our hospital)|Odds Ratio (OR)|3.02||||0.023|TWO_SIDED|95.0|1.13|8.0|||Chi-squared|||||8.0|1.13|0.023
74013030|NCT02605187|147576310|SUPERIORITY|||||||0.882||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at rest 24 hours after delivery. Null Hypothesis: all the means are the same.||||0.882
74013031|NCT02605187|147576310|SUPERIORITY|||||||0.565||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at movement 24 hours after delivery. Null Hypothesis: all the means are the same.||||0.565
74013032|NCT02605187|147576310|SUPERIORITY|||||||0.022||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at rest 48 hours after delivery. Null Hypothesis: all the means are the same.||||0.022
74013033|NCT02605187|147576310|SUPERIORITY|||||||0.14||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at movement 48 hours after delivery. Null Hypothesis: all the means are the same.||||0.140
74013034|NCT02605187|147576311|SUPERIORITY|||||||0.311||||||Final parameter estimates would be considered significant at P \< 0.05.|Fisher Exact|||Comparison of opioid use 0-24 hours after delivery.||||0.311
74042686|NCT02061748|147637152|SUPERIORITY_OR_OTHER|||||||0.4407|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.4407
74042687|NCT02061748|147637153|SUPERIORITY_OR_OTHER|||||||0.2665|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.2665
74094336|NCT03107026|147739886|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.162||0.0256|TWO_SIDED|95.0|-0.68|-0.04|||Mixed Models Analysis|||||-0.04|-0.68|0.0256
74042688|NCT02061748|147637154|SUPERIORITY_OR_OTHER|||||||0.8017|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8017
74042689|NCT02061748|147637155|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||<0.0001
74094337|NCT03107026|147739886|SUPERIORITY||Median Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.166||0.0025|TWO_SIDED|95.0|-0.83|-0.18|||Mixed Models Analysis|||||-0.18|-0.83|0.0025
74013035|NCT02605187|147576311|SUPERIORITY|||||||0.008||||||Final parameter estimates would be considered significant at P \< 0.05.|Fisher Exact|||Comparison of opioid use 24-48 hours after delivery.||||0.008
74013036|NCT02605187|147576312|SUPERIORITY|||||||0.092|||||||Fisher Exact|||Comparison of presence of pruritus 0-24 hours after delivery.||||0.092
74013037|NCT02605187|147576312|SUPERIORITY|||||||0.269|||||||Fisher Exact|||Comparison of presence of pruritus 24-48 hours after delivery.||||0.269
74013038|NCT02605187|147576313|SUPERIORITY|||||||0.006|||||||ANOVA|||Comparison of pruritus score 24 hours after delivery. Null Hypothesis: all means are equal||||0.006
74042690|NCT02061748|147637156|SUPERIORITY_OR_OTHER|||||||0.2083|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.2083
74042691|NCT02061748|147637157|SUPERIORITY_OR_OTHER|||||||0.0023|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0023
74042692|NCT02061748|147637158|SUPERIORITY_OR_OTHER|||||||0.5331|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.5331
74042693|NCT02061748|147637159|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0003
74042694|NCT02061748|147637160|SUPERIORITY_OR_OTHER|||||||0.2646|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.2646
74042695|NCT02061748|147637161|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0004
74042696|NCT02061748|147637162|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0004
74042697|NCT03706040|147637168|SUPERIORITY||Adjusted Difference|13.0||||0.084|TWO_SIDED|95.0|-1.7|27.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||27.7|-1.7|0.084
74094338|NCT03107026|147739887|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5342|TWO_SIDED|95.0|0.726|1.854|||Regression, Logistic|||||1.854|0.726|0.5342
74094339|NCT03107026|147739887|SUPERIORITY||Odds Ratio (OR)|1.179||||0.4905|TWO_SIDED|95.0|0.738|1.882|||Regression, Logistic|||||1.882|0.738|0.4905
74094340|NCT03107026|147739888|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.946||0.0154|TWO_SIDED|95.0|-4.16|-0.44|||Mixed Models Analysis|||||-0.44|-4.16|0.0154
74094341|NCT03107026|147739888|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|0.969||0.0005|TWO_SIDED|95.0|-5.31|-1.5|||Mixed Models Analysis|||||-1.50|-5.31|0.0005
74094342|NCT04711902|147739905|OTHER|estimation and confidence interval|Marginal difference|39.91|||||TWO_SIDED|95.0|10.87|68.95|||Regression, Logistic|||||68.95|10.87|
74013039|NCT02605187|147576313|SUPERIORITY|||||||0.296|||||||ANOVA|||Comparison of pruritus score 48 hours after delivery. Null Hypothesis: all means are equal||||0.296
74013040|NCT02605187|147576314|SUPERIORITY|||||||0.759|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 0-24 hours after delivery.||||0.759
74013041|NCT02605187|147576314|SUPERIORITY|||||||0.761|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 24-48 hours after delivery.||||0.761
74013042|NCT02605187|147576315|SUPERIORITY|||||||0.281|||||||Chi-squared|||||||0.281
74013043|NCT02605187|147576316|SUPERIORITY|||||||0.786|||||||ANOVA|||Comparison of nausea score 24 hours after delivery. Null Hypothesis: all means are equal||||0.786
74042698|NCT03706040|147637168|SUPERIORITY||Adjusted Difference|10.0||||0.179|TWO_SIDED|95.0|-4.6|24.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.6|-4.6|0.179
74042699|NCT03706040|147637169|SUPERIORITY||Adjusted Difference|8.7||||0.129|TWO_SIDED|95.0|-2.5|20.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||20.0|-2.5|0.129
74042700|NCT03706040|147637169|SUPERIORITY||Adjusted Difference|0.0||||0.994|TWO_SIDED|95.0|-9.4|9.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||9.4|-9.4|0.994
74042701|NCT03706040|147637170|SUPERIORITY||Adjusted Difference|13.7||||0.001|TWO_SIDED|95.0|5.4|22.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||22.1|5.4|0.001
74042702|NCT03706040|147637170|SUPERIORITY||Adjusted Difference|15.3|||<|0.001|TWO_SIDED|95.0|6.6|24.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.0|6.6|<0.001
74042703|NCT03706040|147637171|SUPERIORITY||Least Squares (LS) Mean Difference|-10.32|STANDARD_ERROR_OF_MEAN|11.073||0.353|TWO_SIDED|95.0|-32.25|11.61|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||11.61|-32.25|0.353
74094343|NCT04711902|147739906|OTHER|estimation and confidence interval|Marginal difference|11.86|||||TWO_SIDED|95.0|-7.18|30.91|||Regression, Logistic|||||30.91|-7.18|
74094344|NCT04711902|147739907|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-1.1|||||TWO_SIDED|95.0|-1.68|-0.52|||Mixed Models Analysis|||||-0.52|-1.68|
74094345|NCT04711902|147739908|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-1.65|||||TWO_SIDED|95.0|-2.35|-0.94|||Mixed Models Analysis|||||-0.94|-2.35|
74094346|NCT04711902|147739909|OTHER|estimation and confidence interval|Mixed model repeated scores (MMRM)|4.2|||||TWO_SIDED|95.0|0.94|7.46|||Mixed Models Analysis|||||7.46|0.94|
74094347|NCT04711902|147739910|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-0.4|||||TWO_SIDED|95.0|-0.58|-0.21|||Mixed Models Analysis|||||-0.21|-0.58|
74094348|NCT03347422|147739936|SUPERIORITY||Odds Ratio (OR)|15.94|||<|0.001|TWO_SIDED|95.0|2.88|88.04||Threshold for significance was 0.05.|Cochran-Mantel-Haenszel||Stratified by baseline hemoglobin (\< median versus \>=median) and geographic region (Asia/Other, North America, and Europe).|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.||88.04|2.88|<0.001
74013044|NCT02605187|147576316|SUPERIORITY|||||||0.985|||||||ANOVA|||Comparison of nausea score at 48 hours after delivery. Null Hypothesis: all means are equal||||0.985
74013045|NCT02605187|147576317|SUPERIORITY|||||||0.057|||||||Chi-squared|||Comparison of participants who need nausea treatment from 0-24 hours after delivery.||||0.057
74013046|NCT02605187|147576317|SUPERIORITY|||||||0.246|||||||Fisher Exact|||Comparison of participants who need nausea treatment from 24-48 hours after delivery.||||0.246
74013047|NCT02605187|147576318|SUPERIORITY|||||||0.226|||||||ANOVA|||Comparison of average number of vomiting episodes 0-24 hours after delivery. Null Hypothesis: all means are equal||||0.226
74013048|NCT02605187|147576319|SUPERIORITY|||||||0.036|||||||ANOVA|||||||0.036
74013049|NCT02605187|147576320|SUPERIORITY|||||||0.019|||||||ANOVA|||Comparison of satisfaction with pain medication 24 hours after delivery.||||0.019
74013050|NCT02605187|147576320|SUPERIORITY|||||||0.873|||||||ANOVA|||Comparison of satisfaction with pain medication 48 hours after delivery.||||0.873
74013051|NCT05433571|147576321|SUPERIORITY|Superiority was tested for Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (Low DC) and concluded if the lower limit of a 95% confidence interval was above 0.80|Mean Population Estimate|0.917|STANDARD_ERROR_OF_MEAN|0.0194|||TWO_SIDED|95.0|0.878|0.955|||Bootstrapping Methods|bias adjusted confidence intervals||||0.955|0.878|
74013052|NCT05433571|147576321|SUPERIORITY|Superiority was tested for Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) and concluded if the lower limit of a 95% confidence interval was above 0.80|Mean Population Estimate|0.887|STANDARD_ERROR_OF_MEAN|0.0219|||TWO_SIDED|95.0|0.845|0.93|||Bootstrapping Methods|bias adjusted confidence intervals||||0.930|0.845|
74013053|NCT01761084|147576338|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.58|1.94||||||||1.94|.58|
74013054|NCT01761084|147576339|SUPERIORITY||Risk Ratio (RR)|1.32|||||TWO_SIDED|95.0|0.99|1.74||||||||1.74|.99|
74013055|NCT01761084|147576340|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.811|TWO_SIDED|95.0|-0.84|1.07|||t-test, 2 sided|Intention-to-treat analysis|Intention-to-treat analysis|Baseline||1.07|-0.84|0.811
74013056|NCT01761084|147576340|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.765|TWO_SIDED|95.0|-0.8|1.09|||t-test, 2 sided||Per-protocol analysis|Month 12||1.09|-0.80|0.765
74013057|NCT01761084|147576341|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.796|TWO_SIDED|95.0|-0.8|0.61|||t-test, 2 sided||Intention-to-treat analysis|Baseline||0.61|-0.80|0.796
74013058|NCT01761084|147576341|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.888|TWO_SIDED|95.0|-0.75|0.65|||t-test, 2 sided||Per-protocol analysis|Month 12||0.65|-0.75|0.888
74013059|NCT01761084|147576342|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.719|TWO_SIDED|95.0|-0.54|0.78|||t-test, 2 sided||Intention-to-treat analysis|Baseline||0.78|-0.54|0.719
74013060|NCT01761084|147576342|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.745|TWO_SIDED|95.0|-0.56|0.79|||t-test, 2 sided||Per-protocol analysis|Month 12||0.79|-0.56|0.745
74013061|NCT01761084|147576343|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.854|TWO_SIDED|95.0|-5.66|6.83|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in EQ5D - VAS||6.83|-5.66|0.854
74013062|NCT01761084|147576343|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.585|TWO_SIDED|95.0|-4.66|8.22|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in EQ5D-VAS||8.22|-4.66|0.585
74013063|NCT01761084|147576343|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.335|TWO_SIDED|95.0|-0.16|0.47|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in OQLQ Average Score||0.47|-0.16|0.335
74013064|NCT01761084|147576343|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.285|TWO_SIDED|95.0|-0.15|0.5|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in OQLQ Average Score||0.50|-0.15|0.285
74013065|NCT01761084|147576343|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.225|TWO_SIDED|95.0|-1.36|0.32|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS at rest||0.32|-1.36|0.225
74013066|NCT01761084|147576343|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.488|TWO_SIDED|95.0|-1.16|0.56|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS at rest||0.56|-1.16|0.488
74013067|NCT01761084|147576343|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.808|TWO_SIDED|95.0|-0.68|0.88|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS during movement||0.88|-0.68|0.808
74013068|NCT01761084|147576343|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.566|TWO_SIDED|95.0|-0.57|1.04|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS during movement||1.04|-0.57|0.566
74013069|NCT01761084|147576346|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.951|TWO_SIDED|95.0|-1.412|1.501|||t-test, 2 sided|||Baseline||1.501|-1.412|.951
74013070|NCT01761084|147576346|SUPERIORITY||Mean Difference (Final Values)|-1.396||||0.039|TWO_SIDED|95.0|-2.721|-0.071|||t-test, 2 sided|||Month 12||-0.071|-2.721|0.039
74013071|NCT01761084|147576347|SUPERIORITY||Mean Difference (Final Values)|-65.9|||<|0.05|TWO_SIDED|95.0|-91.8|-40.0||Month 6 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.||-40.0|-91.8|<0.05
74013072|NCT01761084|147576347|SUPERIORITY||Mean Difference (Final Values)|-49.3|||<|0.05|TWO_SIDED|95.0|-69.8|-28.8||Month 12 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.||-28.8|-69.8|<0.05
74013073|NCT01761084|147576352|SUPERIORITY||Incident Rate Ratio|0.97|||||TWO_SIDED|95.0|0.58|1.63||||||Negative Binomial Regression.||1.63|.58|
74013074|NCT01761084|147576355|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.536|TWO_SIDED|95.0|-0.28|0.53|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in height||0.53|-0.28|0.536
74013075|NCT01761084|147576356|SUPERIORITY||Mean Difference (Net)|-0.055||||0.9|TWO_SIDED|95.0|-0.917|0.807|||t-test, 2 sided|||Month 12 scores.||0.807|-0.917|.900
74013076|NCT01761084|147576357|SUPERIORITY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|13.9||0.712|TWO_SIDED|95.0|-33.6|23.2|||t-test, 2 sided|||Baseline||23.2|-33.6|.712
74013077|NCT01761084|147576357|SUPERIORITY||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|15.3||0.6|TWO_SIDED|95.0|-23.3|39.5|||t-test, 1 sided|||Month 12||39.5|-23.3|.60
74013078|NCT01761084|147576359|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.461|TWO_SIDED|95.0|-0.25|0.55|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in weight||0.55|-0.25|0.461
74042704|NCT03706040|147637171|SUPERIORITY||LS Mean Difference|-16.86|STANDARD_ERROR_OF_MEAN|11.305||0.139|TWO_SIDED|95.0|-39.24|5.53|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||5.53|-39.24|0.139
74042705|NCT03706040|147637174|SUPERIORITY||Adjusted Difference|12.9||||0.171|TWO_SIDED|95.0|-5.6|31.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||31.4|-5.6|0.171
74042706|NCT03706040|147637174|SUPERIORITY||Adjusted Difference|5.7||||0.552|TWO_SIDED|95.0|-13.1|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.5|-13.1|0.552
74042707|NCT03706040|147637176|SUPERIORITY||Adjusted Difference|11.6||||0.022|TWO_SIDED|95.0|1.7|21.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||21.6|1.7|0.022
74042708|NCT03706040|147637176|SUPERIORITY||Adjusted Difference|5.8||||0.192|TWO_SIDED|95.0|-2.9|14.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||14.4|-2.9|0.192
74042709|NCT03706040|147637179|SUPERIORITY||LS Mean Difference|-6.24|STANDARD_ERROR_OF_MEAN|4.506||0.169|TWO_SIDED|95.0|-15.15|2.68|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||2.68|-15.15|0.169
74042710|NCT03706040|147637179|SUPERIORITY||LS Mean Difference|-5.86|STANDARD_ERROR_OF_MEAN|4.589||0.204|TWO_SIDED|95.0|-14.94|3.22|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||3.22|-14.94|0.204
74042711|NCT03706040|147637181|SUPERIORITY||Adjusted Difference|6.7||||0.422|TWO_SIDED|95.0|-9.7|23.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||23.1|-9.7|0.422
74042712|NCT03706040|147637181|SUPERIORITY||Adjusted Difference|-5.2||||0.505|TWO_SIDED|95.0|-20.3|10.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||10.0|-20.3|0.505
74094349|NCT03347422|147739938|SUPERIORITY||LS mean difference|2.56|STANDARD_ERROR_OF_MEAN|0.408|<|0.001|TWO_SIDED|95.0|1.75|3.38||Threshold of significance at 0.05 level.|Mixed model for repeated measures|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||3.38|1.75|<0.001
74094350|NCT03347422|147739939|SUPERIORITY||LS mean difference|8.93|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|4.0|13.85||Threshold of significance at 0.05 level.|Mixed model for repeated measures|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||13.85|4.00|<0.001
74013079|NCT00940589|147576361|SUPERIORITY_OR_OTHER||||||<|0.045|TWO_SIDED||||||ANCOVA|||||||<0.045
74013080|NCT00940589|147576362|SUPERIORITY_OR_OTHER||||||<|0.044|TWO_SIDED||||||ANCOVA|||||||<0.044
74094351|NCT02397408|147739999|OTHER||||||<|0.008|||||||Wilcoxon (Mann-Whitney)|||||||<.008
74013081|NCT00676676|147576363|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Baseline versus 2-week||||0.002
74013082|NCT00676676|147576363|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Baseline versus 8-week||||0.004
74013083|NCT01918007|147576382|SUPERIORITY||Odds Ratio (OR)|1.3||||0.54|TWO_SIDED|95.0|0.5|3.3|||Chi-squared|||||3.3|0.5|0.54
74013084|NCT01918007|147576383|SUPERIORITY||Odds Ratio (OR)|14.0|||<|0.001|TWO_SIDED|95.0|2.9|68.4|||Chi-squared|||||68.4|2.9|<0.001
74013085|NCT01918007|147576384|SUPERIORITY||Mean Difference (Net)|-0.31|||<|0.001|TWO_SIDED|95.0|-0.35|-0.27|||t-test, 2 sided|||||-0.27|-0.35|<0.001
74013086|NCT01918007|147576385|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74042713|NCT03706040|147637183|SUPERIORITY||Adjusted Difference|10.1||||0.005|TWO_SIDED|95.0|3.0|17.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||17.3|3.0|0.005
74042714|NCT03706040|147637183|SUPERIORITY||Adjusted Difference|2.9||||0.151|TWO_SIDED|95.0|-1.1|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||6.8|-1.1|0.151
74042715|NCT03706040|147637185|SUPERIORITY||Adjusted Difference|5.9||||0.035|TWO_SIDED|95.0|0.4|11.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||11.3|0.4|0.035
74042716|NCT03706040|147637185|SUPERIORITY||Adjusted Difference|1.5||||0.311|TWO_SIDED|95.0|-1.4|4.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||4.4|-1.4|0.311
74042717|NCT03706040|147637187|SUPERIORITY||Adjusted Difference|-0.3||||0.965|TWO_SIDED|95.0|-12.0|11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||11.5|-12.0|0.965
74042718|NCT03706040|147637187|SUPERIORITY||Adjusted Difference|-3.1||||0.583|TWO_SIDED|95.0|-14.3|8.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||8.1|-14.3|0.583
74042719|NCT03706040|147637191|SUPERIORITY||Adjusted Difference|5.9||||0.539|TWO_SIDED|95.0|-13.0|24.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.9|-13.0|0.539
74042720|NCT03706040|147637191|SUPERIORITY||Adjusted Difference|12.2||||0.213|TWO_SIDED|95.0|-7.0|31.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||31.5|-7.0|0.213
74042721|NCT03706040|147637193|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.82||0.988|TWO_SIDED|95.0|-3.6|3.6|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||3.6|-3.6|0.988
74042722|NCT03706040|147637193|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.86||0.594|TWO_SIDED|95.0|-4.7|2.7|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||2.7|-4.7|0.594
74042723|NCT03706040|147637197|SUPERIORITY||LS Mean Difference|-1.318|STANDARD_ERROR_OF_MEAN|0.6137||0.033|TWO_SIDED|95.0|-2.531|-0.105|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||-0.105|-2.531|0.033
74042724|NCT03706040|147637197|SUPERIORITY||LS Mean Difference|-1.648|STANDARD_ERROR_OF_MEAN|0.626||0.009|TWO_SIDED|95.0|-2.885|-0.411|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||-0.411|-2.885|0.009
74042725|NCT03788616|147637217|EQUIVALENCE|assuming 95% power of the study|Median Difference (Final Values)|0.05||||0.478|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.478
74042726|NCT01673490|147637240|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74042727|NCT01673490|147637241|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||for Month 3|t-test, 2 sided|||||||<0.001
74042728|NCT01673490|147637241|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||for Month 6|t-test, 2 sided|||||||<0.001
74042729|NCT02940860|147637247|NON_INFERIORITY|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.06|0.23|||||The Mixed Model for Repeated Measurement (MMRM) used for testing, included the fixed, categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."||0.23|-0.06|
74042730|NCT02940860|147637248|OTHER||95% two-sided CI (iron isomaltoside)|0.3|||||TWO_SIDED|95.0|0.06|0.86||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."||0.86|0.06|
74042731|NCT02940860|147637248|OTHER||Risk Difference (RD)|0.29|||||TWO_SIDED|95.0|-0.19|0.77||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.77|-0.19|
74042732|NCT02940860|147637248|NON_INFERIORITY|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.48|-0.57|
74042733|NCT02940860|147637249|SUPERIORITY|||||||0.0248|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher's exact test.||||0.0248
74042734|NCT02940860|147637250|SUPERIORITY|||||||0.0185|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.||||0.0185
74042735|NCT02940860|147637252|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0478|TWO_SIDED|95.0|1.0|1.87|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥1 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.87|1.00|0.0478
74042736|NCT02940860|147637252|SUPERIORITY||Odds Ratio (OR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.39|2.36|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥1 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||2.36|1.39|<0.0001
74042737|NCT02940860|147637252|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0048|TWO_SIDED|95.0|1.11|1.79|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥1 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.79|1.11|0.0048
74042738|NCT02940860|147637252|SUPERIORITY||Odds Ratio (OR)|1.01||||0.944|TWO_SIDED|95.0|0.8|1.27|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥1 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.27|0.80|0.9440
74013087|NCT01918007|147576386|SUPERIORITY||Mean Difference (Net)|-2.76|||<|0.001|TWO_SIDED|95.0|-3.63|-1.9|||t-test, 2 sided|||||-1.90|-3.63|<0.001
74013088|NCT01918007|147576387|SUPERIORITY||Risk Ratio (RR)|1.16||||0.553|TWO_SIDED|95.0|0.71|1.89|||Chi-squared|||||1.89|0.71|0.553
74042739|NCT02940860|147637253|SUPERIORITY|||||||0.0174|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.||||0.0174
74042740|NCT02940860|147637254|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5074|TWO_SIDED|95.0|0.83|1.45|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of \>12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.||1.45|0.83|0.5074
74042741|NCT02940860|147637255|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1035|TWO_SIDED|95.0|0.96|1.6|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."||1.60|0.96|0.1035
74042742|NCT02940860|147637256|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.0001|TWO_SIDED|95.0|1.38|2.4|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."||2.40|1.38|<0.0001
74013089|NCT01918007|147576388|SUPERIORITY||Risk Ratio (RR)|1.79||||0.057|TWO_SIDED|95.0|0.98|3.27|||Chi-squared|||||3.27|0.98|0.057
74013090|NCT01918007|147576389|SUPERIORITY||Risk Ratio (RR)|2.29||||0.084|TWO_SIDED|95.0|0.84|6.25|||Chi-squared|||||6.25|0.84|0.084
74013091|NCT01918007|147576390|SUPERIORITY|||||||0.547|||||||Wilcoxon (Mann-Whitney)|||||||0.547
74013092|NCT01918007|147576391|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||||||0.062
74013093|NCT01918007|147576392|SUPERIORITY|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
74013094|NCT01918007|147576393|SUPERIORITY|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
74013095|NCT01918007|147576394|SUPERIORITY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
74013096|NCT01261507|147576399|SUPERIORITY_OR_OTHER||difference in areas under the LROC curve|-0.059|STANDARD_ERROR_OF_MEAN|0.037|<|0.05|TWO_SIDED|95.0|-0.086|-0.031|||mixed model:Dorfman, Berbaum, Metz|||Measure is the difference between the radiologists working without the software less the value for the radiologists working with the software. Thus a negative value would indicate that the the radiologists showed better results when using the software.||-0.031|-0.086|<0.05
74013097|NCT00393887|147576451|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Fisher Exact|||Two-sided Fisher's exact test||||0.11
74013098|NCT03503877|147576452|SUPERIORITY|||||||0.07|||||||Wilcoxon signed-rank testing|||||||0.07
74013099|NCT03503877|147576453|SUPERIORITY|||||||0.89|||||||Wilcoxon signed-rank testing|||||||0.89
74042743|NCT02940860|147637257|SUPERIORITY||Mean Difference (Final Values)|0.22|||<|0.0001|TWO_SIDED|95.0|0.12|0.31|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.31|0.12|<0.0001
74042744|NCT02940860|147637257|SUPERIORITY||Mean Difference (Final Values)|0.25|||<|0.0001|TWO_SIDED|95.0|0.14|0.36|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.36|0.14|<0.0001
74013100|NCT03503877|147576454|SUPERIORITY|||||||0.54||||||High mosaicism|Wilcoxon signed-rank testing|||||||0.54
74013101|NCT03503877|147576454|SUPERIORITY|||||||0.2||||||Low mosaicism|Wilcoxon signed-rank|||||||.20
74042745|NCT02940860|147637257|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0208|TWO_SIDED|95.0|0.02|0.28|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.28|0.02|0.0208
74042746|NCT02940860|147637258|SUPERIORITY||Mean Difference (Final Values)|309.2|||<|0.0001|TWO_SIDED|95.0|280.7|337.8|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||337.8|280.7|<0.0001
74042747|NCT02940860|147637258|SUPERIORITY||Mean Difference (Final Values)|95.8|||<|0.0001|TWO_SIDED|95.0|67.9|123.7|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||123.7|67.9|<0.0001
74042748|NCT02940860|147637258|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.7834|TWO_SIDED|95.0|-21.2|28.1|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||28.1|-21.2|0.7834
74094352|NCT01524679|147740010|SUPERIORITY|The Fisher Test with asymptotic test statistic provided by the analysis software was used.|||||<|0.0001||||||This was the only a priori defined primary endpoint. There was no adjustment for multiple comparisons.|Fisher Exact|There was no adjustment for other variables intended for the primary analysis. Confounding variables were analysed in subsequent analyses.||Nullhypothesis was the equality of response rates of the treatment group and the control group. Treatments were compared by a two-sided Fisher test on a level of significance of 0.05. The study was appropriately powered (80%) for this analysis.||||<0.0001
74094353|NCT01524679|147740011|SUPERIORITY||Mean Difference (Final Values)|0.7525||||0.0957|TWO_SIDED|95.0|0.5382|1.0521|||ANCOVA|||||1.0521|0.5382|0.0957
74013102|NCT03503877|147576455|SUPERIORITY|||||||0.01||||||Time to Expanded Blastocyst|Wilcoxon signed-rank testing|||||||0.01
74013103|NCT04962022|147576456|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir co-administered with itraconazole was the Test treatment.|Specified in comments|118.57||||0.05|TWO_SIDED|90.0|112.5|124.97|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"|||124.97|112.50|0.05
74013104|NCT04962022|147576457|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir co-administered with itraconazole was the Test treatment.|Specified in comments|138.82||||0.05|TWO_SIDED|90.0|129.25|149.11|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"|||149.11|129.25|0.05
74094354|NCT01524679|147740012|SUPERIORITY||Mean Difference (Final Values)|0.4621||||0.0005|TWO_SIDED|95.0|0.4621|0.7106|||ANCOVA|||||0.7106|0.4621|0.0005
74094355|NCT04040322|147740020|SUPERIORITY||Least squares mean difference in change|-1.26||||0.421|TWO_SIDED|95.0|-4.34|1.82||Threshold for statistical significance was p \< 0.05|ANCOVA|||||1.82|-4.34|0.4210
74094356|NCT03801265|147740024|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||.770
74094357|NCT03801265|147740025|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||.826
74094358|NCT03801265|147740026|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||.859
73888011|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|38.8||||0.0543|TWO_SIDED|95.0|-0.7|78.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||78.3|-0.7|0.0543
74013105|NCT01146873|147576475|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|0.107|||<|0.001|TWO_SIDED||||||Kaplan-Meier methods|||||||<0.001
74013106|NCT01146873|147576476|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|-0.007|||<|0.001|TWO_SIDED||||||Kaplan-Meier methods|||||||<0.001
73879875|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|10.92|||<|0.0001|TWO_SIDED|95.0|3.53|33.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.74|3.53|<0.0001
73879876|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|12.18|||<|0.0001|TWO_SIDED|95.0|3.91|37.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||37.89|3.91|<0.0001
73879877|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2244|TWO_SIDED|95.0|0.64|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.92|0.64|0.2244
74013107|NCT01146873|147576477|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
74013108|NCT01146873|147576479|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
74013109|NCT01399788|147576521|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.81|||||TWO_SIDED|90.0|99.2|108.64||||||Rifampicin; 32 participants (16 per sequence) provided at least 99% power that 90% confidence interval (CI) for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject coefficient of variation (CV) estimate of approximately 14.5% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||108.64|99.20|
74013110|NCT01399788|147576521|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|107.28|||||TWO_SIDED|90.0|101.95|112.9||||||Isoniazid; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.0% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||112.90|101.95|
74013111|NCT01399788|147576521|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.48|||||TWO_SIDED|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.9% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.25|94.92|
74042749|NCT02940860|147637258|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.7621|TWO_SIDED|95.0|-18.1|24.7|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||24.7|-18.1|0.7621
74094359|NCT03801265|147740027|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.904|||||||Wilcoxon (Mann-Whitney)|||||||.904
74094360|NCT03801265|147740028|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||.122
74013112|NCT01399788|147576522|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|102.75|||||TWO_SIDED|90.0|95.36|110.71||||||Rifampicin: 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||110.71|95.36|
74013113|NCT01399788|147576522|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.85|||||TWO_SIDED|90.0|92.13|117.07||||||Isoniazid; 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||117.07|92.13|
74013114|NCT01399788|147576522|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.48|||||TWO_SIDED|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 16.0% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.25|94.92|
74013115|NCT01399788|147576523|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|101.73|||||TWO_SIDED|90.0|99.12|104.4||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 5.2% for AUClast was used for this power calculation. Natural log transformed AUClast(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.40|99.12|
73879878|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|8.58||||0.0002|TWO_SIDED|95.0|2.77|26.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||26.53|2.77|0.0002
74042750|NCT02940860|147637259|SUPERIORITY||Mean Difference (Final Values)|8.8|||<|0.0001|TWO_SIDED|95.0|6.9|10.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||10.7|6.9|<0.0001
74042751|NCT02940860|147637259|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.0129|TWO_SIDED|95.0|0.3|2.4|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.4|0.3|0.0129
74042752|NCT02940860|147637259|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.2403|TWO_SIDED|95.0|-0.4|1.5|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.5|-0.4|0.2403
74042753|NCT02940860|147637259|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8094|TWO_SIDED|95.0|-0.9|1.2|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.2|-0.9|0.8094
74042754|NCT02940860|147637260|SUPERIORITY||Mean Difference (Final Values)|26.5|||<|0.0001|TWO_SIDED|95.0|20.4|32.7|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||32.7|20.4|<0.0001
74042755|NCT02940860|147637260|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.2229|TWO_SIDED|95.0|-1.2|5.1|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||5.1|-1.2|0.2229
74042756|NCT02940860|147637260|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.9046|TWO_SIDED|95.0|-2.9|2.6|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||2.6|-2.9|0.9046
74042757|NCT02940860|147637260|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.1307|TWO_SIDED|95.0|-5.8|0.8|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||0.8|-5.8|0.1307
74042758|NCT02940860|147637261|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8196|TWO_SIDED|95.0|-0.73|0.92|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.92|-0.73|0.8196
74042759|NCT02940860|147637261|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.7132|TWO_SIDED|95.0|-1.06|0.73|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.73|-1.06|0.7132
74094361|NCT03801265|147740029|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.379|||||||Wilcoxon (Mann-Whitney)|||||||.379
74094362|NCT03801265|147740030|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.881|||||||Wilcoxon (Mann-Whitney)|||||||.881
74094363|NCT03801265|147740031|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.818|||||||Wilcoxon (Mann-Whitney)|||||||.818
73879879|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|8.25||||0.0002|TWO_SIDED|95.0|2.71|25.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.13|2.71|0.0002
73879880|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.04||||0.0149|TWO_SIDED|95.0|1.24|7.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.45|1.24|0.0149
74013116|NCT01399788|147576524|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|95.17|||||TWO_SIDED|90.0|88.6|102.22||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 6.7% for Cmax was used for this power calculation. Natural log transformed Cmax(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.22|88.60|
74013117|NCT01399788|147576525|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|104.3|||||TWO_SIDED|90.0|99.7|109.1||||||Rifampicin; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||109.10|99.70|
74013118|NCT01399788|147576525|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|105.74|||||TWO_SIDED|90.0|100.32|111.46||||||Isoniazid; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||111.46|100.32|
74013119|NCT01399788|147576525|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|100.97|||||TWO_SIDED|90.0|96.28|105.88||||||Ethambutol; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||105.88|96.28|
74013120|NCT01399788|147576526|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|101.8|||||TWO_SIDED|90.0|99.24|104.43||||||Pyrazinamide; Natural log transformed AUC (0 -∞)(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.43|99.24|
74013121|NCT02919436|147576529|SUPERIORITY|We found observed rate of postoperative urinary retention in male spine surgery patients to historically be 17%. We hypothesize that the use of tamsulosin can reduce this rate by 50%. A two group continuity corrected chi-square test with a .05 two-sided significance level will have 80% power to detect the difference between a control group proportion of .17 and a treatment group proportion of .085 (odds ratio of .454) when the sample size in each group is 264 and a total sample size of 528.||||||0.96|||||||Chi-squared, Corrected|||||||.96
74013122|NCT03699007|147576532|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74013123|NCT03699007|147576533|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74013124|NCT03259074|147576541|SUPERIORITY||Marginal difference|1.51||||0.7164|TWO_SIDED|95.0|-6.63|9.64||Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.|Regression, Logistic|||||9.64|-6.63|0.7164
74042760|NCT02940860|147637261|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.586|TWO_SIDED|95.0|-0.71|1.25|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||1.25|-0.71|0.5860
74013125|NCT03259074|147576541|SUPERIORITY||Marginal difference|1.67||||0.6925|TWO_SIDED|95.0|-6.61|9.95|||Regression, Logistic|Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.||||9.95|-6.61|0.6925
74013126|NCT03259074|147576542|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS mean difference|-0.18|||||TWO_SIDED|95.0|-0.646|0.293|||||ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.|||0.293|-0.646|
74013127|NCT03259074|147576542|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS mean difference|-0.16|||||TWO_SIDED|95.0|-0.639|0.315|||||ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.|||0.315|-0.639|
74013128|NCT03259074|147576543|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|4.32|||||TWO_SIDED|95.0|-5.62|14.27|||||Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.|||14.27|-5.62|
74013129|NCT03259074|147576543|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|1.09|||||TWO_SIDED|95.0|-9.13|11.31|||||Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.|||11.31|-9.13|
74013130|NCT03259074|147576544|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS Means|0.183|STANDARD_ERROR_OF_MEAN|0.1517|||TWO_SIDED|95.0|-0.12|0.48|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 150 mg||0.48|-0.12|
74013131|NCT03259074|147576544|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|LS Means|0.332|STANDARD_ERROR_OF_MEAN|0.1545|||TWO_SIDED|95.0|0.03|0.64|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 300 mg||0.64|0.03|
74013132|NCT03259074|147576545|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS Means|0.877|STANDARD_ERROR_OF_MEAN|0.3316|||TWO_SIDED|95.0|0.22|1.53|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 150 mg||1.53|0.22|
74042761|NCT03170258|147637309|OTHER|||||||0.0015|||||||t-test, 2 sided|One-sample 2-sided t-test against a mean of 0 used to evaluate the main effect of VTA activation during neurofeedback.||||||0.0015
74042762|NCT03170258|147637310|OTHER||||||>|0.1|||||||t-test, 1 sided|One-sample t-test against 0 for the ratio of Beta to Theta power.||||||>0.10
74013133|NCT03259074|147576545|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|LS Means|0.419|STANDARD_ERROR_OF_MEAN|0.3357|||TWO_SIDED|95.0|-0.24|1.08|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 300 mg||1.08|-0.24|
74013134|NCT03259074|147576546|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|1.54|||||TWO_SIDED|95.0|-5.1|8.18|||||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||8.18|-5.10|
74013135|NCT03259074|147576547|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|-2.34|||||TWO_SIDED|95.0|-10.18|5.51|||||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method.|||5.51|-10.18|
74013136|NCT03259074|147576548|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|Marginal difference|2.18|||||TWO_SIDED|95.0|-5.34|9.69|||Marginal difference||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||9.69|-5.34|
74013137|NCT03259074|147576549|OTHER||Marginal difference|0.33|||||TWO_SIDED|95.0|-7.08|7.74||Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||7.74|-7.08|
74013138|NCT00530270|147576659|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.127
74013139|NCT00530270|147576660|SUPERIORITY_OR_OTHER|||||||0.801||||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.801
74013140|NCT00530270|147576661|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.02
74013141|NCT00530270|147576662|SUPERIORITY_OR_OTHER|||||||0.876||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.876
74042763|NCT01783470|147637329|EQUIVALENCE|All p values presented are two tailed. p values \< 0.05 were considered to indicate statistical significance for the primary outcome.||||||0.001|||||||Wilcoxon sign-ranks test|||Since the sample size of twelve subjects limited the ability to demonstrate that measurements were normally distributed, we used the non-parametric Wilcoxon sign-ranks test to assess the primary and secondary endpoints. All p values presented are two tailed. p values \< 0.05 were considered to indicate statistical significance for the primary outcome.||||0.001
74013142|NCT00530270|147576663|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.770
74013143|NCT01757678|147576665|OTHER||Difference in Probability|0.14|||||TWO_SIDED|95.0|0.09|0.19||||||||.19|.09|
73888012|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|50.2||||0.0131|TWO_SIDED|95.0|10.7|89.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||89.7|10.7|0.0131
74094364|NCT03801265|147740032|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.678|||||||Wilcoxon (Mann-Whitney)|||||||.678
74094365|NCT03801265|147740033|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||.002
74094366|NCT03801265|147740034|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.007|||||||Chi-squared|||||||.007
74094367|NCT03801265|147740035|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.271|||||||Wilcoxon (Mann-Whitney)|||||||.271
74094368|NCT03801265|147740036|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||.810
74013144|NCT01757678|147576666|OTHER||Difference in Probability|0.09|||||TWO_SIDED|95.0|0.04|0.14||||||||.14|.04|
74013145|NCT03972969|147576672|SUPERIORITY||Incidence Rate Ratio|0.13|||<|0.05|TWO_SIDED|95.0|0.05|0.32|||negative binomial regression|||||0.32|0.05|<0.05
74013146|NCT03972969|147576672|SUPERIORITY||Incidence Rate Ratio|0.25|||<|0.05|TWO_SIDED|95.0|0.1|0.61|||negative binomial regression|||||0.61|0.10|<0.05
74013147|NCT03972969|147576672|SUPERIORITY||Incidence Rate Ratio|0.52|||<|0.05|TWO_SIDED|95.0|0.19|1.38|||negative binomial regression|||||1.38|0.19|<0.05
74013148|NCT03972969|147576673|SUPERIORITY||Incidence Rate Ratio|0.15|||<|0.05|TWO_SIDED|95.0|0.07|0.33|||negative binomial regression|||||0.33|0.07|<0.05
74013149|NCT03972969|147576673|SUPERIORITY||Incidence Rate Ratio|0.26|||<|0.05|TWO_SIDED|95.0|0.11|0.58|||negative binomial regression|||||0.58|0.11|<0.05
74013150|NCT03972969|147576673|SUPERIORITY||Incidence Rate Ratio|0.58|||<|0.05|TWO_SIDED|95.0|0.25|1.38|||negative binomial regression|||||1.38|0.25|<0.05
74013151|NCT01074190|147576677|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||.34
74013152|NCT01074190|147576678|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||.1
74013153|NCT01074190|147576679|SUPERIORITY|||||||0.1|||||||Chi-squared|||A sample size of 315 achieves 80% power to detect a difference among groups using a 2 degrees of freedom Chi-Square Test with a significance level (alpha) of 0.05.||||.1
74013154|NCT02409290|147576689|SUPERIORITY||Cox Proportional Hazard|0.2||||0.0016|TWO_SIDED|95.0|0.07|0.61|||Log Rank|||||0.61|0.07|0.0016
74013155|NCT02409290|147576690|SUPERIORITY||Cox Proportional Hazard|0.11||||0.0005|TWO_SIDED|95.0|0.03|0.5|||Log Rank|||Control regimen (arm B) uses concurrent controls only||0.50|0.03|0.0005
74013156|NCT00708500|147576691|SUPERIORITY_OR_OTHER||Treatment Difference|37.4|||<|0.0001||95.0|25.7|49.1|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||49.1|25.7|<0.0001
74013157|NCT00708500|147576691|SUPERIORITY_OR_OTHER||Treatment Difference|45.2|||<|0.0001||95.0|33.7|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||56.8|33.7|<0.0001
74013158|NCT00708500|147576692|SUPERIORITY_OR_OTHER||Treatment Difference|39.1|||<|0.0001||95.0|27.2|51.0|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||51.0|27.2|<0.0001
74013159|NCT00708500|147576692|SUPERIORITY_OR_OTHER||Treatment Difference|45.1|||<|0.0001||95.0|33.4|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||56.8|33.4|<0.0001
74013160|NCT00595556|147576699|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Mixed Models Analysis|||||||.012
74013161|NCT00595556|147576700|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||Mixed Models Analysis|||||||.94
74013162|NCT00595556|147576701|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Mixed Models Analysis|||||||.004
74013163|NCT00595556|147576702|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Mixed Models Analysis|||||||.006
74013164|NCT00595556|147576703|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Mixed Models Analysis|||||||.3
74013165|NCT00705783|147576704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.199|||<|0.0001|TWO_SIDED|95.0|0.125|0.317|||Log Rank||Aripiprazole depot/placebo depot|Based on 6-month IR rates of 55% for placebo and 35% for aripiprazole, sample sizes were estimated to achieve 90% power to detect a hazard ratio of 0.54 and to preserve an overall nominal alpha level of 0.05 (2-sided), allowing for 2 interim looks at 50% and 75% of events. Assuming that each subject was followed for 12 months after randomization and allowing for a 25% loss to follow-up, the projected total number of subjects to be randomly assigned to treatment in the trial was 225.||0.317|0.125|<0.0001
74013166|NCT00705783|147576705|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The alpha levels for this key secondary Outcome Measure were the same as used for the primary Outcome Measure.|Chi-squared|||||||<0.0001
74013167|NCT00705783|147576706|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
74013168|NCT00705783|147576707|SUPERIORITY_OR_OTHER|||||||0.1756||95.0|||||Chi-squared|||||||0.1756
74013169|NCT00705783|147576708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.11|||<|0.0001|TWO_SIDED|95.0|-12.68|-7.54|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-7.54|-12.68|<0.0001
74013170|NCT00705783|147576709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.35|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-0.35|-0.70|<0.0001
74094369|NCT03801265|147740037|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||.676
73879881|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|4.65||||0.0011|TWO_SIDED|95.0|1.85|11.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.73|1.85|0.0011
74042764|NCT00247273|147637331|NON_INFERIORITY_OR_EQUIVALENCE|In order to establish noninferiority for the primary efficacy variable at one-sided α of 2.5% with 90% power, a total of 1068 patients, 534 per treatment group, is required. This calculation is based on the following assumptions: the noninferiority margin (or delta) = 1.5%, the common SD (standard deviation) of the percent change from baseline in lumbar spine BMD at Month 12 = 4.5%, the 1 year dropout rate = 20%, and the true mean difference μD - μM = 0.5%.|Least Square (LS) Mean Difference|-0.115|||||TWO_SIDED|95.0|-0.505|0.274|||ANOVA|Fixed effects for treatment and pooled center||||0.274|-0.505|
74042765|NCT00247273|147637332|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.076|||||TWO_SIDED|95.0|-0.475|0.323|||ANOVA|Fixed effects for treatment and pooled center.||||0.323|-0.475|
74042766|NCT00247273|147637333|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0005|||||TWO_SIDED|95.0|-0.0035|0.0024|||ANOVA|Fixed effects for treatment and pooled center.||||0.0024|-0.0035|
74094370|NCT03801265|147740038|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.908|||||||Wilcoxon (Mann-Whitney)|||||||.908
74094371|NCT03801265|147740039|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||.270
74094372|NCT03801265|147740040|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||.015
73879882|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|6.36||||0.0001|TWO_SIDED|95.0|2.46|16.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.45|2.46|0.0001
74013171|NCT00705783|147576710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82|||<|0.0001|TWO_SIDED|95.0|-4.72|-2.91|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||Positive Subscale Score||-2.91|-4.72|<0.0001
74013172|NCT00705783|147576711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0001|TWO_SIDED|95.0|-2.04|-0.67|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-0.67|-2.04|0.0001
74013173|NCT00705783|147576712|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
74013174|NCT00705783|147576713|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
74013175|NCT02184195|147576721|SUPERIORITY||Hazard Ratio (HR)|0.531||||0.0038|TWO_SIDED|95.0|0.346|0.815|||Log-rank test|||||0.815|0.346|0.0038
74013176|NCT02184195|147576722|OTHER||Hazard Ratio (HR)|0.831||||0.3487|TWO_SIDED|95.0|0.564|1.224|||Log-rank test|||||1.224|0.564|0.3487
74013177|NCT02184195|147576723|SUPERIORITY||Hazard Ratio (HR)|0.659||||0.0613|TWO_SIDED|95.0|0.426|1.02|||Log-rank test|||||1.020|0.426|0.0613
74042767|NCT00247273|147637334|NON_INFERIORITY_OR_EQUIVALENCE|The estimates of the common SD, dropout rate at month 24 and true difference are also based on previous risedronate Phase III studies (RVN008993, RVE009093, ROE009394, HMR4003E/3001).|LS Mean Difference|-0.239|||||TWO_SIDED|95.0|-0.727|0.249|||ANOVA|Fixed effects for treatment and pooled centers.||The sample size of 1068 patients will provide approximately 90% power to demonstrate the noninferiority of the monthly regimen at month 24, using a 2% noninferiority margin and assuming a common SD of the percent change from baseline in lumbar spine BMD at month 24 of 5%, a 2-year dropout rate of 30%, and a true mean difference (uDaily-uMonthly) of 0.8%.||0.249|-0.727|
74094373|NCT03801265|147740041|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||.203
74013178|NCT02184195|147576724|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.0111|TWO_SIDED|95.0|0.418|0.894|||Log-rank test|||||0.894|0.418|0.0111
74013179|NCT02184195|147576725|SUPERIORITY||Hazard Ratio (HR)|0.442|||<|0.0001|TWO_SIDED|95.0|0.297|0.658|||Log-rank test|||||0.658|0.297|<0.0001
74013180|NCT02184195|147576726|SUPERIORITY||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.289|0.627|||Log-rank test|||||0.627|0.289|<0.0001
74013181|NCT02184195|147576727|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3273|TWO_SIDED|95.0|0.668|3.61|||Regression, Logistic|||||3.610|0.668|0.3273
74013182|NCT02184195|147576729|SUPERIORITY||Mean Difference (Final Values)|-2.21||||0.355|TWO_SIDED|95.0|-6.917|2.496|||Mixed Models Analysis|||||2.496|-6.917|0.355
74013183|NCT02997735|147576734|SUPERIORITY||Odds Ratio (OR)|7.78|||<|0.001|TWO_SIDED|95.0|2.81|27.9|||Chi-squared||ORs from multivariable logistic regression model of characteristics associated with successful quitline enrollment.|||27.90|2.81|<0.001
74013184|NCT02997735|147576735|SUPERIORITY||Odds Ratio (OR)|0.48||||0.15|TWO_SIDED|95.0|0.13|1.72|||Chi-squared||1-5 years Row (\<1 Ref)|||1.72|0.13|0.15
74013185|NCT02997735|147576735|SUPERIORITY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.18|2.12|||||6-12 years Row (\<1 Ref)|||2.12|0.18|
74013186|NCT02997735|147576735|SUPERIORITY||Odds Ratio (OR)|1.82|||||TWO_SIDED|95.0|0.49|6.94|||||13 or Older Row (\<1 Ref)|||6.94|0.49|
74042768|NCT00247273|147637335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.085|||||TWO_SIDED|95.0|-0.609|0.439|||ANOVA|Fixed Effects for treatment \& pooled center||||0.439|-0.609|
73879883|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|6.87||||0.0001|TWO_SIDED|95.0|2.56|18.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.46|2.56|0.0001
73879884|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0897|TWO_SIDED|95.0|0.89|5.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.34|0.89|0.0897
73879885|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.46||||0.007|TWO_SIDED|95.0|1.42|8.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.53|1.42|0.0070
73879886|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.75||||0.0041|TWO_SIDED|95.0|1.52|9.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.23|1.52|0.0041
73879887|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0254|TWO_SIDED|95.0|1.13|6.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.78|1.13|0.0254
73879888|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0032|TWO_SIDED|95.0|1.59|10.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.04|1.59|0.0032
73879889|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|6.25||||0.0002|TWO_SIDED|95.0|2.37|16.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.51|2.37|0.0002
73879890|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|8.78|||<|0.0001|TWO_SIDED|95.0|3.0|25.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.70|3.00|<0.0001
73879891|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0214|TWO_SIDED|95.0|1.17|7.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.18|1.17|0.0214
73879892|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0049|TWO_SIDED|95.0|1.48|9.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.09|1.48|0.0049
74013187|NCT02997735|147576736|SUPERIORITY||Odds Ratio (OR)|2.38||||0.028|TWO_SIDED|95.0|0.92|6.5|||Chi-squared||35-49 years Row (18-34 Ref)|||6.50|0.92|0.028
74013188|NCT02997735|147576736|SUPERIORITY||Odds Ratio (OR)|5.1|||||TWO_SIDED|95.0|1.46|17.32|||||50 or older Row (18-34 Ref)|||17.32|1.46|
74013189|NCT02997735|147576737|SUPERIORITY||Odds Ratio (OR)|1.1||||0.85|TWO_SIDED|95.0|0.4|2.8|||Chi-squared||Asthma Row (No asthma Ref)|||2.80|0.40|0.85
74013190|NCT02997735|147576738|SUPERIORITY||Odds Ratio (OR)|2.07||||0.086|TWO_SIDED|95.0|0.9|6.5|||Chi-squared||10 or more cigarettes Row (\<10 cigarettes Ref)|||6.50|0.90|0.086
74013191|NCT02997735|147576739|SUPERIORITY||Odds Ratio (OR)|0.47||||0.35|TWO_SIDED|95.0|0.15|1.27|||Chi-squared||Less than 6 months Row (30 days Ref)|||1.27|0.15|0.35
74013192|NCT02997735|147576739|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.15|2.21|||||||6 or more months Row (30 days Ref)|2.21|0.15|
74042769|NCT00247273|147637336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0009|||||TWO_SIDED|95.0|-0.0048|0.0029|||ANOVA|Fixed effects for treatment and pooled center.||||0.0029|-0.0048|
74042770|NCT00247273|147637337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|-2.83|3.28|||ANOVA|Fixed effects for treatment and pooled center.||||3.28|-2.83|
74013193|NCT01664559|147576759|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.99
74013194|NCT01664559|147576760|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1\) Anticipated pain||||0.31
74013195|NCT01664559|147576760|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2\) pain with injection||||0.33
74013196|NCT01664559|147576760|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3\) speculum insertion||||0.72
74013197|NCT01664559|147576760|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||4\) tenaculum placement||||0.36
74013198|NCT01664559|147576760|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||5\) uterine sounding||||0.64
74013199|NCT01664559|147576760|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||6\) 5 min after placement||||<0.001
74013200|NCT01664559|147576760|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||7\) 15 min after placement||||<0.001
74042771|NCT00247273|147637338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57|||||TWO_SIDED|95.0|-4.47|1.33|||ANOVA|Fixed effects for treatment and pooled center||||1.33|-4.47|
74042772|NCT00247273|147637339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.54|4.53|||ANOVA|Fixed effects for treatment and pooled center||||4.53|-2.54|
74042773|NCT00247273|147637340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.83|||||TWO_SIDED|95.0|-6.45|0.8|||ANOVA|Fixed effects for treatment and pooled center.||||0.80|-6.45|
74042774|NCT00247273|147637341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.05|0.0|||ANOVA|Fixed effects for treatment and pooled center||||0.00|-0.05|
74013201|NCT01664559|147576761|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1\) anticipated pain||||0.6
74013202|NCT01664559|147576761|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2\) pain with injection||||1.0
74013203|NCT01664559|147576761|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3\) speculum insertion||||0.34
74013204|NCT01664559|147576761|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||4\) tenaculum placement||||0.32
74013205|NCT01664559|147576761|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||5\) uterine sounding||||0.04
74013206|NCT01664559|147576761|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||6\) IUD placement||||0.02
74013207|NCT01664559|147576761|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||7\) 5 min after placement||||0.32
74013208|NCT01664559|147576761|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||8\) 15 min after placement||||0.02
74094374|NCT03801265|147740042|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||.672
74094375|NCT00886288|147740095|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74013209|NCT01664559|147576762|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||Reported side effects (nausea, vomiting, dyspepsia, headache, dizziness, drowsiness, injection site itchiness, swelling or pain)||||> 0.05
74013210|NCT01664559|147576762|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||Injection site pain (just as bad or worse than IUD procedure)||||0.76
74013211|NCT01664559|147576762|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||Satisfied or very satisfied with IUD placement procedure||||0.76
74013212|NCT01664559|147576762|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Chi-squared|||Would recommend IUD placement to a friend||||0.35
74013213|NCT01664559|147576762|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Desires additional pain medication||||0.02
74013214|NCT01664559|147576763|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|||Level of training, PGY 1, 2, 3, 4 and Attending||||0.2
74013215|NCT01664559|147576763|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Chi-squared|||IUD type (levonorgestrel or copper)||||0.09
74013216|NCT01664559|147576763|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Purpose of IUD (contraception or heavy menstrual bleeding)||||1.0
74013217|NCT01664559|147576763|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Chi-squared|||Position of uterus (anteverted, retroverted, midpositioned)||||0.92
73888013|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9||||0.0297|TWO_SIDED|95.0|4.4|83.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.5|4.4|0.0297
74013218|NCT01664559|147576763|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Need for cervical dilation||||1.0
74013219|NCT01664559|147576763|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared, Corrected|||Able to complete the IUD insertion||||1.0
74013220|NCT01664559|147576763|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Chi-squared|||Significant bleeding||||0.24
74013221|NCT01664559|147576763|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Major complications||||1.0
74013222|NCT01664559|147576763|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Took acetaminophen prior to leaving the office||||0.02
74013223|NCT02255409|147576765|OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-6.7|9.7||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22||9.7|-6.7|
74013224|NCT02255409|147576765|OTHER||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-14.2|2.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22||2.3|-14.2|
74013225|NCT02255409|147576765|OTHER||Mean Difference (Final Values)|16.3|||||TWO_SIDED|95.0|8.4|24.1||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22||24.1|8.4|
74013226|NCT02255409|147576765|OTHER||Mean Difference (Final Values)|14.2|||||TWO_SIDED|95.0|6.3|22.0||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22||22.0|6.3|
74013227|NCT02255409|147576766|OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.9|2.2||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22||2.2|-0.9|
74013228|NCT02255409|147576766|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.9|1.2||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22||1.2|-1.9|
74013229|NCT02255409|147576766|OTHER||Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|9.3|20.0||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22||20.0|9.3|
74013230|NCT02255409|147576766|OTHER||Mean Difference (Final Values)|26.0|||||TWO_SIDED|95.0|20.6|32.0||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22||32.0|20.6|
74013231|NCT02255409|147576770|OTHER||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-1.6|13.0||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181||13.0|-1.6|
74013232|NCT02255409|147576770|OTHER||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-5.5|9.8||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||9.8|-5.5|
74013233|NCT02255409|147576770|OTHER||Mean Difference (Final Values)|11.8|||||TWO_SIDED|95.0|5.3|18.3||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||18.3|5.3|
74013234|NCT02255409|147576770|OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-8.4|5.7||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181||5.7|-8.4|
74013235|NCT02255409|147576771|OTHER||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|2.4|8.4||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181||8.4|2.4|
74013236|NCT02255409|147576771|OTHER||Mean Difference (Final Values)|5.6|||||TWO_SIDED|95.0|3.1|9.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||9.3|3.1|
74013237|NCT02255409|147576771|OTHER||Mean Difference (Final Values)|33.2|||||TWO_SIDED|95.0|25.0|40.9||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||40.9|25.0|
73879893|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0078|TWO_SIDED|95.0|1.38|8.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.22|1.38|0.0078
73879894|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0727|TWO_SIDED|95.0|0.93|5.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.63|0.93|0.0727
74013238|NCT02255409|147576771|OTHER||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|29.6|44.7||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181||44.7|29.6|
74013239|NCT02255409|147576772|OTHER||GMT Ratio|1.94|||||TWO_SIDED|95.0|1.6|2.4||||||The ratio of GMT (GMTr) values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 1.||2.4|1.6|
74013240|NCT02255409|147576772|OTHER||GMT Ratio|1.48|||||TWO_SIDED|95.0|1.3|1.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 22.||1.7|1.3|
74094376|NCT01675661|147740115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.985|TWO_SIDED|95.0|0.63|1.59|||Regression, Logistic|OR=1.00||For the primary outcome measure, a repeated-measures logistic regression model was used to analyze the odds of a negative urine cannabinoid test as an indicator of abstinence across all 12 weeks of treatment. A generalized estimating equations (GEEs) were used to adjust for this correlation with multiple samples per participant. The model for the primary analysis included the main effect of treatment, main effect of time, site effects, effect of smoking tobacco, and timeXtreatment interaction.||1.59|0.63|0.985
74094377|NCT02393248|147740128|SUPERIORITY|||||||0.2841|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2841
74013241|NCT02255409|147576772|OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|1.3|1.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 181.||1.7|1.3|
74013242|NCT02255409|147576772|OTHER||GMT Ratio|2.16|||||TWO_SIDED|95.0|1.7|2.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.||2.7|1.7|
74013243|NCT02255409|147576772|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.2|1.5||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||1.5|1.2|
74013244|NCT02255409|147576772|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.2|1.6||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||1.6|1.2|
74013245|NCT02255409|147576772|OTHER||GMT Ratio|1.82|||||TWO_SIDED|95.0|1.5|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.||2.2|1.5|
74013246|NCT02255409|147576772|OTHER||GMT Ratio|1.75|||||TWO_SIDED|95.0|1.5|2.0||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 22.||2.0|1.5|
74013247|NCT02255409|147576772|OTHER||GMT Ratio|1.85|||||TWO_SIDED|95.0|1.6|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 181.||2.2|1.6|
74013248|NCT02255409|147576772|OTHER||GMT Ratio|3.24|||||TWO_SIDED|95.0|2.7|4.0||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 1.||4.0|2.7|
74013249|NCT02255409|147576772|OTHER||GMT Ratio|1.49|||||TWO_SIDED|95.0|1.2|1.8||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 22.||1.8|1.2|
74013250|NCT02255409|147576772|OTHER||GMT Ratio|1.29|||||TWO_SIDED|95.0|1.1|1.5||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 181.||1.5|1.1|
74013251|NCT02255409|147576774|OTHER||Mean Difference (Final Values)|5.7|||||TWO_SIDED|95.0|-5.2|16.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||16.3|-5.2|
74013252|NCT02255409|147576774|OTHER||Mean Difference (Final Values)|14.5|||||TWO_SIDED|95.0|5.3|23.6||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||23.6|5.3|
74013253|NCT02255409|147576775|OTHER||Mean Difference (Final Values)|16.3|||||TWO_SIDED|95.0|9.5|24.1||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||24.1|9.5|
74013254|NCT02255409|147576775|OTHER||Mean Difference (Final Values)|46.4|||||TWO_SIDED|95.0|35.9|55.8||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||55.8|35.9|
74013255|NCT02255409|147576776|OTHER||GMT Ratio|2.63|||||TWO_SIDED|95.0|1.8|3.8||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.||3.8|1.8|
74013256|NCT02255409|147576776|OTHER||GMT Ratio|1.57|||||TWO_SIDED|95.0|1.3|2.9||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||2.9|1.3|
74013257|NCT02255409|147576776|OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|1.3|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||2.2|1.3|
74013258|NCT02255409|147576776|OTHER||GMT Ratio|1.99|||||TWO_SIDED|95.0|1.5|2.6||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.||2.6|1.5|
74013259|NCT02255409|147576776|OTHER||GMT Ratio|2.21|||||TWO_SIDED|95.0|1.8|2.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||2.7|1.8|
74013260|NCT02255409|147576776|OTHER||GMT Ratio|2.55|||||TWO_SIDED|95.0|2.1|3.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||3.2|2.1|
74013261|NCT02189213|147576822|OTHER|The parameters were the CGI-Improvement scale which comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale. The hypothesis is that \~50% of subjects receiving treatment will not respond.|||||=|0.0002|||||||t-test, 2 sided|||At least 50% of subjects will respond to Sertraline treatment (CGI greater than or equal to 2).||||=0.0002
74013262|NCT00135668|147576847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.2|STANDARD_DEVIATION|16.16|<|0.001|TWO_SIDED|95.0|-18.44|-13.97|||t-test, 2 sided|Paired t-test used.||Paired t-test used to test the null hypothesis of no change in MAP from baseline.||-13.97|-18.44|<0.001
74013263|NCT00135668|147576847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|15.68|<|0.001|TWO_SIDED|95.0|-15.45|-6.55|||t-test, 2 sided|Paired t-test.||||-6.55|-15.45|<0.001
74013264|NCT00135668|147576847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.0|STANDARD_DEVIATION|12.88|<|0.001|TWO_SIDED|95.0|-20.7|-13.3|||t-test, 2 sided|Paired t-test.||||-13.30|-20.70|<0.001
74013265|NCT00135668|147576847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|STANDARD_DEVIATION|15.95|<|0.001|TWO_SIDED|95.0|-24.38|-15.58|||t-test, 2 sided|Paired t-test.||||-15.58|-24.38|<0.001
74094378|NCT02393248|147740128|SUPERIORITY|||||||0.3042|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.3042
74013266|NCT00135668|147576847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.6|STANDARD_DEVIATION|18.63|<|0.001|TWO_SIDED|95.0|-21.87|-11.39|||t-test, 2 sided|Paired t-test||||-11.39|-21.87|<0.001
74094379|NCT02393248|147740128|SUPERIORITY|||||||0.1259|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1259
74094380|NCT02393248|147740128|SUPERIORITY|||||||0.8214|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.8214
74094381|NCT02393248|147740128|SUPERIORITY|||||||0.4315|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.4315
74094382|NCT02393248|147740128|SUPERIORITY|||||||0.2595|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2595
74094383|NCT02393248|147740132|SUPERIORITY|||||||0.8577|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.8577
74013267|NCT00345176|147576899|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||<|0.013|TWO_SIDED|98.7|0.76|1.07||Adjusted for 3 treatment versus placebo comparisons and interim analyses|Regression, Cox|Adjusted for baseline AMD status|The reference group is placebo.|Each of the 3 active arms was compared to the placebo/control arm.||1.07|0.76|<0.013
74013268|NCT00345176|147576899|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97|||<|0.013|TWO_SIDED|98.7|0.82|1.16||Adjusted for multiple comparisons|Regression, Cox|||||1.16|0.82|<0.013
74013269|NCT00345176|147576899|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||<|0.013|TWO_SIDED|98.7|0.75|1.06|||Regression, Cox|Adjusted for multiple comparisons||||1.06|0.75|<0.013
74013270|NCT00345176|147576900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||<|0.05|TWO_SIDED|95.0|0.84|1.08|||Regression, Cox|||||1.08|0.84|<0.05
74013271|NCT00345176|147576900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||<|0.05|TWO_SIDED|95.0|0.84|1.09|||Regression, Cox|||||1.09|0.84|<0.05
74013272|NCT00345176|147576900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.83|1.07|||Regression, Cox|||||1.07|0.83|<0.05
74013273|NCT00345176|147576901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||<|0.05|TWO_SIDED|95.0|0.77|1.4|||Regression, Cox|||Comparison of Lutein/Zeaxantin versus Control for mortality||1.40|0.77|<0.05
74013274|NCT00345176|147576901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||<|0.05|TWO_SIDED|95.0|0.84|1.52|||Regression, Cox|||Comparison of DHA/EPA versus Placebo for mortality||1.52|0.84|<0.05
74094384|NCT02393248|147740132|SUPERIORITY|||||||0.7238|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.7238
74094385|NCT02393248|147740132|SUPERIORITY|||||||0.5923|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.5923
74094386|NCT02393248|147740132|SUPERIORITY|||||||0.7634|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.7634
74094387|NCT02393248|147740132|SUPERIORITY|||||||0.5749|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.5749
74094388|NCT02393248|147740132|SUPERIORITY|||||||0.6877|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.6877
74094389|NCT02393248|147740136|SUPERIORITY|||||||0.143|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.143
74013275|NCT00345176|147576901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23|||<|0.05|TWO_SIDED|95.0|0.92|1.65|||Regression, Cox|||Comparison of Lutein/Zeaxanthin + DHA/EPA versus Placebo for Mortality||1.65|0.92|<0.05
74013276|NCT00345176|147576902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||<|0.05|TWO_SIDED|95.0|0.84|1.1|||Regression, Cox|||||1.10|0.84|<0.05
74013277|NCT01136655|147576908|SUPERIORITY_OR_OTHER||LS mean difference|0.114|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.087|0.142|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.142|0.087|<0.0001
74013278|NCT01136655|147576908|SUPERIORITY_OR_OTHER||LS mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.078|0.133|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.133|0.078|<0.0001
74013279|NCT01136655|147576908|SUPERIORITY_OR_OTHER||LS mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.0141||0.0001|TWO_SIDED|95.0|0.03|0.085|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.085|0.030|0.0001
74094390|NCT02393248|147740137|SUPERIORITY|||||||0.0013|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.0013
74094391|NCT02393248|147740138|SUPERIORITY|||||||0.319|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.319
74094392|NCT02393248|147740139|SUPERIORITY|||||||0.128|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.128
74094393|NCT02393248|147740140|SUPERIORITY|||||||0.305|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.305
74094394|NCT02393248|147740141|SUPERIORITY|||||||0.305|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.305
74094395|NCT02393248|147740142|SUPERIORITY|||||||0.772|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.772
74094396|NCT00117325|147740159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.335||||0.05|TWO_SIDED|95.0|-0.67|0.0|||ANCOVA|Analysis of covariance (ANCOVA) method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.00|-0.67|0.050
74094397|NCT00117325|147740160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.393||||0.027|TWO_SIDED|95.0|-0.74|-0.05||Week 1-4|ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||-0.05|-0.74|0.027
74094398|NCT00117325|147740161|SUPERIORITY_OR_OTHER|||||||0.184|||||||Regression, Logistic|logistic regression adjusting for age, gender, investigator, and treatment.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis.|Effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period (Total response) was analyzed.|||0.184
74094399|NCT00117325|147740162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.348||||0.051|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.00|-0.70|0.051
73879895|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0199|TWO_SIDED|95.0|1.19|7.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.29|1.19|0.0199
73879896|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0034|TWO_SIDED|95.0|1.61|11.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.01|1.61|0.0034
73879897|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|6.26||||0.0007|TWO_SIDED|95.0|2.16|18.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.26|2.16|0.0007
73879898|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1206|TWO_SIDED|95.0|0.83|4.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.92|0.83|0.1206
73879899|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.58||||0.007|TWO_SIDED|95.0|1.42|9.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.03|1.42|0.0070
73879900|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.41||||0.0088|TWO_SIDED|95.0|1.36|8.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.54|1.36|0.0088
74013280|NCT01136655|147576908|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0139||0.5223|TWO_SIDED|95.0|-0.036|0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.018|-0.036|0.5223
74013281|NCT01136655|147576908|SUPERIORITY_OR_OTHER||LS mean difference|-0.057|STANDARD_ERROR_OF_MEAN|0.0139||0.0001|TWO_SIDED|95.0|-0.084|-0.029|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.029|-0.084|0.0001
73879901|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4485|TWO_SIDED|95.0|0.58|3.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||3.40|0.58|0.4485
73879902|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.92||||0.0255|TWO_SIDED|95.0|1.14|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.47|1.14|0.0255
74042775|NCT00247273|147637342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-7.98|-0.36|||ANOVA|Fixed effects for treatment and pooled center||||-0.36|-7.98|
74042776|NCT00247273|147637343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.01|||ANOVA|Fixed effects for treatment and pooled center||||0.01|-0.06|
74042777|NCT00247273|147637344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69|||||TWO_SIDED|95.0|-12.04|0.66|||ANOVA|Fixed effects for treatment and pooled center||||0.66|-12.04|
74094400|NCT00117325|147740163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.304||||0.076|TWO_SIDED|95.0|-0.64|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis||0.03|-0.64|0.076
73879903|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0066|TWO_SIDED|95.0|1.49|11.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.75|1.49|0.0066
73879904|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0061|TWO_SIDED|95.0|1.53|13.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.01|1.53|0.0061
74013282|NCT01136655|147576908|SUPERIORITY_OR_OTHER||LS mean difference|-0.048|STANDARD_ERROR_OF_MEAN|0.0138||0.0007|TWO_SIDED|95.0|-0.075|-0.02|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.020|-0.075|0.0007
74013283|NCT01136655|147576908|SUPERIORITY_OR_OTHER||LS mean difference|-0.114|STANDARD_ERROR_OF_MEAN|0.0141|<|0.0001|TWO_SIDED|95.0|-0.142|-0.086|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.086|-0.142|<0.0001
74042778|NCT00247273|147637345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.29|0.64|||ANOVA|Fixed effects for treatment and pooled center||||0.64|-0.29|
74094401|NCT00117325|147740164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.51||||0.093|TWO_SIDED|95.0|-9.77|0.75|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.75|-9.77|0.093
74042779|NCT00247273|147637346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31|||||TWO_SIDED|95.0|-0.85|3.48|||ANOVA|Fixed effects for treatment and pooled center||||3.48|-0.85|
74042780|NCT00247273|147637347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.45|0.7|||ANOVA|Fixed effects for treatment and pooled center||||0.70|-0.45|
74013284|NCT01136655|147576908|SUPERIORITY_OR_OTHER||LS mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.0141||0.0001|TWO_SIDED|95.0|-0.084|-0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.028|-0.084|0.0001
74013285|NCT01136655|147576908|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0141||0.5394|TWO_SIDED|95.0|-0.036|0.019|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.019|-0.036|0.5394
74013286|NCT01136655|147576908|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.9863|TWO_SIDED|95.0|-0.027|0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.028|-0.027|0.9863
74013287|NCT01136655|147576909|SUPERIORITY_OR_OTHER||LS mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.056|0.155|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.155|0.056|<0.0001
74013288|NCT01136655|147576909|SUPERIORITY_OR_OTHER||LS mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.0252||0.0092|TWO_SIDED|95.0|0.017|0.116|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.116|0.017|0.0092
74013289|NCT01136655|147576909|SUPERIORITY_OR_OTHER||LS mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.0252||0.5509|TWO_SIDED|95.0|-0.035|0.065|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.065|-0.035|0.5509
74013290|NCT01136655|147576909|SUPERIORITY_OR_OTHER||LS mean difference|-0.039|STANDARD_ERROR_OF_MEAN|0.0249||0.1163|TWO_SIDED|95.0|-0.088|0.01|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.010|-0.088|0.1163
74013291|NCT01136655|147576909|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025||0.0004|TWO_SIDED|95.0|-0.14|-0.041|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.041|-0.140|0.0004
74013292|NCT01136655|147576909|SUPERIORITY_OR_OTHER||LS mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.0247||0.04|TWO_SIDED|95.0|-0.1|-0.002|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.002|-0.100|0.0400
74013293|NCT01136655|147576909|SUPERIORITY_OR_OTHER||LS mean difference|-0.083|STANDARD_ERROR_OF_MEAN|0.0252||0.0011|TWO_SIDED|95.0|-0.133|-0.034|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.034|-0.133|0.0011
73888014|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|41.3||||0.0407|TWO_SIDED|95.0|1.8|80.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.8|1.8|0.0407
74013294|NCT01136655|147576909|SUPERIORITY_OR_OTHER||LS mean difference|-0.068|STANDARD_ERROR_OF_MEAN|0.0254||0.0077|TWO_SIDED|95.0|-0.118|-0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.018|-0.118|0.0077
74013295|NCT01136655|147576909|SUPERIORITY_OR_OTHER||LS mean difference|-0.017|STANDARD_ERROR_OF_MEAN|0.0252||0.4957|TWO_SIDED|95.0|-0.067|0.033|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.033|-0.067|0.4957
74013296|NCT01136655|147576909|SUPERIORITY_OR_OTHER||LS mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.025||0.38|TWO_SIDED|95.0|-0.027|0.071|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.071|-0.027|0.3800
74013297|NCT01136655|147576910|SUPERIORITY_OR_OTHER||LS mean difference|0.107|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.073|0.14|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.140|0.073|<0.0001
74042781|NCT00247273|147637348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-3.96|2.43|||ANOVA|Fixed effects for treatment and pooled center||||2.43|-3.96|
74042782|NCT00247273|147637349|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||1|TWO_SIDED|95.0|0.36|2.54|||Fisher Exact|||||2.54|0.36|1.0000
74042783|NCT00247273|147637350|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98||||1|TWO_SIDED|95.0|0.47|2.03|||Fisher Exact|||||2.03|0.47|1.0000
74094402|NCT00117325|147740165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.372||||0.023|TWO_SIDED|95.0|-11.8|-0.9|||ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||-0.90|-11.8|0.023
74094403|NCT00117325|147740166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.118||||0.061|TWO_SIDED|95.0|-0.24|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.01|-0.24|0.061
74094404|NCT00117325|147740166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.061|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal Congestion||0.01|-0.25|0.061
74094405|NCT00117325|147740166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.095||||0.138|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.03|-0.22|0.138
74042784|NCT01510834|147637351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.824|STANDARD_DEVIATION|14.148||0.001|TWO_SIDED|95.0|-10.578|-3.07|||t-test, 2 sided|||||-3.070|-10.578|.001
73879905|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.22||||0.0879|TWO_SIDED|95.0|0.89|5.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.57|0.89|0.0879
73879906|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0389|TWO_SIDED|95.0|1.05|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.83|1.05|0.0389
73879907|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0446|TWO_SIDED|95.0|1.02|6.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.73|1.02|0.0446
73879908|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8196|TWO_SIDED|95.0|0.45|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||2.72|0.45|0.8196
73879909|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.0||||0.145|TWO_SIDED|95.0|0.79|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.10|0.79|0.1450
73879910|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|4.08||||0.0114|TWO_SIDED|95.0|1.37|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.11|1.37|0.0114
73879911|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.29||||0.0307|TWO_SIDED|95.0|1.12|9.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.71|1.12|0.0307
73879912|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5921|TWO_SIDED|95.0|0.51|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.24|0.51|0.5921
74013298|NCT01136655|147576910|SUPERIORITY_OR_OTHER||LS mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.0171|<|0.0001|TWO_SIDED|95.0|0.078|0.146|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.146|0.078|<0.0001
74013299|NCT01136655|147576910|SUPERIORITY_OR_OTHER||LS mean difference|0.057|STANDARD_ERROR_OF_MEAN|0.0172||0.0011|TWO_SIDED|95.0|0.023|0.09|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.090|0.023|0.0011
74013300|NCT01136655|147576910|SUPERIORITY_OR_OTHER||LS mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.0169||0.7589|TWO_SIDED|95.0|-0.028|0.039|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.039|-0.028|0.7589
74013301|NCT01136655|147576910|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.017||0.0035|TWO_SIDED|95.0|-0.084|-0.017|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.017|-0.084|0.0035
74013302|NCT01136655|147576910|SUPERIORITY_OR_OTHER||LS mean difference|-0.055|STANDARD_ERROR_OF_MEAN|0.0168||0.0011|TWO_SIDED|95.0|-0.089|-0.022|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.022|-0.089|0.0011
73879913|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0502|TWO_SIDED|95.0|1.0|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.26|1.00|0.0502
73879914|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0224|TWO_SIDED|95.0|1.18|9.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.25|1.18|0.0224
73879915|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7225|TWO_SIDED|95.0|0.47|2.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||2.93|0.47|0.7225
73879916|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0762|TWO_SIDED|95.0|0.91|6.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.48|0.91|0.0762
74013303|NCT01136655|147576910|SUPERIORITY_OR_OTHER||LS mean difference|-0.115|STANDARD_ERROR_OF_MEAN|0.0171|<|0.0001|TWO_SIDED|95.0|-0.149|-0.081|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.081|-0.149|<0.0001
74013304|NCT01136655|147576910|SUPERIORITY_OR_OTHER||LS mean difference|-0.058|STANDARD_ERROR_OF_MEAN|0.0172||0.0008|TWO_SIDED|95.0|-0.092|-0.024|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.024|-0.092|0.0008
74013305|NCT01136655|147576910|SUPERIORITY_OR_OTHER||LS mean difference|-0.003|STANDARD_ERROR_OF_MEAN|0.0172||0.8582|TWO_SIDED|95.0|-0.037|0.031|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.031|-0.037|0.8582
74013306|NCT01136655|147576910|SUPERIORITY_OR_OTHER||LS mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.017||0.6276|TWO_SIDED|95.0|-0.042|0.025|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.025|-0.042|0.6276
73879917|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0252|TWO_SIDED|95.0|1.17|10.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.53|1.17|0.0252
73879918|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.98||||0.049|TWO_SIDED|95.0|1.0|8.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.87|1.00|0.0490
73879919|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.97||||0.1773|TWO_SIDED|95.0|0.74|5.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.30|0.74|0.1773
73879920|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0609|TWO_SIDED|95.0|0.96|7.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.16|0.96|0.0609
73879921|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1364|TWO_SIDED|95.0|0.79|5.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.61|0.79|0.1364
73879922|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.36||||0.5268|TWO_SIDED|95.0|0.53|3.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.51|0.53|0.5268
73879923|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1645|TWO_SIDED|95.0|0.75|5.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.46|0.75|0.1645
73879924|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0215|TWO_SIDED|95.0|1.22|12.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||12.57|1.22|0.0215
74013307|NCT01136655|147576911|SUPERIORITY_OR_OTHER||LS mean difference|0.52|||<|0.0001|TWO_SIDED|95.0|0.393|0.7|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.700|0.393|<0.0001
73879925|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.04||||0.06|TWO_SIDED|95.0|0.95|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.69|0.95|0.0600
73879926|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6503|TWO_SIDED|95.0|0.47|3.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.32|0.47|0.6503
73879927|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0683|TWO_SIDED|95.0|0.93|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.88|0.93|0.0683
73879928|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0618|TWO_SIDED|95.0|0.95|8.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.44|0.95|0.0618
73879929|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5621|TWO_SIDED|95.0|0.5|3.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.63|0.50|0.5621
73879930|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.92||||0.2182|TWO_SIDED|95.0|0.68|5.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.40|0.68|0.2182
73879931|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.11||||0.06|TWO_SIDED|95.0|0.95|10.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.15|0.95|0.0600
73879932|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|4.6||||0.029|TWO_SIDED|95.0|1.17|18.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||18.12|1.17|0.0290
74013308|NCT01136655|147576911|SUPERIORITY_OR_OTHER||LS mean difference|0.26|||<|0.0001|TWO_SIDED|95.0|0.194|0.347|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.347|0.194|<0.0001
74013309|NCT01136655|147576911|SUPERIORITY_OR_OTHER||LS mean difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.214|0.396|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.396|0.214|<0.0001
73879933|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8485|TWO_SIDED|95.0|0.4|3.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.04|0.40|0.8485
74013310|NCT01136655|147576911|SUPERIORITY_OR_OTHER||LS mean difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.371|0.659|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.659|0.371|<0.0001
74013311|NCT01136655|147576911|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.0002|TWO_SIDED|95.0|0.409|0.755|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.755|0.409|0.0002
73879934|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1652|TWO_SIDED|95.0|0.73|6.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.42|0.73|0.1652
74013312|NCT01136655|147576911|SUPERIORITY_OR_OTHER||LS mean difference|1.12||||0.4512|TWO_SIDED|95.0|0.827|1.528|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||1.528|0.827|0.4512
74013313|NCT00768521|147576914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.18||||0.008||90.0|7.58|41.06||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.|Primary Hypothesis: Tolterodine LA 4 mg is superior to placebo with respect to change from baseline in maximum cystometric capacity at 4 hours post Dose 7 (i.e., steady state). The expected treatment effect is targeted at 40 mL.|||41.06|7.58|0.008
73879935|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.94||||0.2244|TWO_SIDED|95.0|0.67|5.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.65|0.67|0.2244
74013314|NCT00768521|147576915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63||||0.422||90.0|-11.5|16.71||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.||||16.71|-11.5|0.422
74013315|NCT01970501|147576962|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.905|TWO_SIDED|95.0|0.72|1.45|||Log Rank|||||1.45|.72|0.905
74013316|NCT01970501|147576963|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.961|TWO_SIDED|95.0|0.71|1.42|||Log Rank|||||1.42|0.71|0.961
74013317|NCT01733628|147576980|OTHER|Type of statistical Test: Inequality|Hazard Ratio (HR)|0.94||||0.8166|TWO_SIDED|95.0|0.56|1.59|||Wilcoxon (Mann-Whitney)|||||1.59|0.56|0.8166
74013318|NCT00102960|147576986|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.02|TWO_SIDED|95.0|0.38|0.93|||Regression, Cox|||Statistical analysis compares early therapy 40 weeks (ART-40W) relative to deferred therapy (ART-Def)||0.93|0.38|0.02
74013319|NCT00102960|147576986|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.002|TWO_SIDED|95.0|0.27|0.76|||Regression, Cox|||Statistical analysis compares early therapy 96 weeks (ART-96W) relative to deferred therapy (ART-Def)||0.76|0.27|0.002
74013320|NCT00102960|147576991|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Cummulative Probability|0.13||||0.03|TWO_SIDED|95.0|0.01|0.25|||Proportion test|||Relative to ART-Def, ART-40W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years||0.25|0.01|0.03
74013321|NCT00102960|147576991|SUPERIORITY||Kaplan-Meier Cummulative Probability|0.2||||0.0006|TWO_SIDED|95.0|0.09|0.31|||Proportion test|||Relative to ART-Def, ART-96W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years||0.31|0.09|0.0006
74013322|NCT00102960|147576992|SUPERIORITY_OR_OTHER_LEGACY||Rate per 100 person years|0.0|||<|0.0001|TWO_SIDED|||||This p-value compares event rates per 100 person-years across the three arms|Poisson Regression|||The CHER study compared Grade 3 or 4 clinical event rates per 100 person-years between the three arms using Poisson regression modeling over the study duration of 4.8 years.|The rates per 100 person-years were 33.8 (Arm 1), 21.6 (Arm 2) and 16 (Arm 3)|||<0.0001
74013323|NCT00102960|147576993|SUPERIORITY||Rate per 100 person years|0.0||||0.46|TWO_SIDED||||||Poisson regression|||The event rates per 100 person years were compared across the three arms|The laboratory events per 100 person years across the three arms were: 7 (Deferred arm), 8.1 (early therapy for 40 weeks) and 6 (early therapy for 96 weeks).|||0.46
74013324|NCT00102960|147576996|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48||||0.011|TWO_SIDED|95.0|0.27|0.84|||Regression, Cox||Hazard rate reported above compares early therapy 40 weeks relative to the deferred therapy arm.|The analysis compares ART-40W relative to the ART-Def arm.||0.84|0.27|0.011
74013325|NCT00102960|147576996|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.34||||0.0009|TWO_SIDED|95.0|0.18|0.64|||Regression, Cox||The hazard ratio compares ART-96W relative to the ART-Def arm.|The analysis compares ART-96 Weeks relative to ART-Deferred||0.64|0.18|0.0009
74013326|NCT00102960|147576998|SUPERIORITY||Count of days|0.0||||0.004|TWO_SIDED|||||The p-value here compares the days spent in hospital across the three arms|Poisson regression||||The total number of days/count of days: 1018 (Arm 1), 533 (Arm 2) and 414 (Arm 3) were compared across the three groups by Poisson regression analysis.|||0.004
74013327|NCT00102960|147576999|SUPERIORITY||Hazard Ratio (HR)|0.562||||0.0021|TWO_SIDED|95.0|0.389|0.811|||Regression, Cox|||||0.811|0.389|0.0021
73879936|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2097|TWO_SIDED|95.0|0.71|4.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.84|0.71|0.2097
73879937|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.53||||0.3708|TWO_SIDED|95.0|0.6|3.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.92|0.60|0.3708
74013328|NCT00102960|147576999|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.0038|TWO_SIDED|95.0|0.405|0.84|||Regression, Cox|||||0.840|0.405|0.0038
74013329|NCT02831673|147577045|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 greater than -10%.|Adjusted difference in proportion|-2.6|||||TWO_SIDED|95.0|-6.7|1.5|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<=versus \[vs.\]\>100,000 c/mL) and cluster of differentiation 4+ (CD4+) cell count (\<= vs. \>200 cells per cubic millimeter).|||1.5|-6.7|
74013330|NCT02831673|147577046|OTHER||Adjusted difference in proportion|-0.4|||||TWO_SIDED|95.0|-4.2|3.4|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<=vs.\>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells per cubic millimeter).|||3.4|-4.2|
74013331|NCT02831673|147577047|OTHER||Adjusted difference in proportion|-4.9|||||TWO_SIDED|95.0|-9.8|0.0|||||Week 96. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||0.0|-9.8|
74013332|NCT02831673|147577048|OTHER||Adjusted difference in proportion|-3.6|||||TWO_SIDED|95.0|-9.4|2.1|||||Week 144. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||2.1|-9.4|
74013333|NCT02831673|147577049|OTHER||Hazard Ratio (HR)|1.0||||0.658|TWO_SIDED|95.0|0.86|1.16||The generalized Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalized Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model.|||1.16|0.86|0.658
74013334|NCT02831673|147577053|OTHER||Mean Difference (Net)|17.1||||0.206|TWO_SIDED|95.0|-9.4|43.6|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||43.6|-9.4|0.206
74013335|NCT02831673|147577053|OTHER||Mean Difference (Net)|4.6||||0.754|TWO_SIDED|95.0|-23.9|33.0|||Mixed Model Repeated Measures (MMRM)||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||33.0|-23.9|0.754
74013336|NCT02831673|147577054|OTHER||Mean Difference (Net)|10.8||||0.5|TWO_SIDED|95.0|-20.7|42.4|||Mixed Model Repeated Measures (MMRM)||Week 96. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||42.4|-20.7|0.500
74042785|NCT01510834|147637352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0872|STANDARD_DEVIATION|15.731||0.001|TWO_SIDED|95.0|2.91|11.26|||t-test, 2 sided|||||11.26|2.91|.001
74013337|NCT02831673|147577055|OTHER||Mean Difference (Net)|-1.4||||0.934|TWO_SIDED|95.0|-34.2|31.5|||Mixed Model Repeated Measures (MMRM)||Week 144.Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||31.5|-34.2|0.934
74013338|NCT02831673|147577066|OTHER||Mean Difference (Net)|-0.02||||0.025|TWO_SIDED|95.0|-0.04|0.0|||Mixed Model Repeated Measures||Serum Cystatin C, Week 24|||0.00|-0.04|0.025
74013339|NCT02831673|147577066|OTHER||Mean Difference (Net)|-0.03||||0.001|TWO_SIDED|95.0|-0.05|-0.01|||Mixed Model Repeated Measures||Serum Cystatin C, Week 48|||-0.01|-0.05|0.001
74013340|NCT02831673|147577066|OTHER||Mean Difference (Net)|-0.3||||0.683|TWO_SIDED|95.0|-1.6|1.0|||Mixed Model Repeated Measures||Serum RBP, Week 24|||1.0|-1.6|0.683
74013341|NCT02831673|147577066|OTHER||Mean Difference (Net)|-0.1||||0.93|TWO_SIDED|95.0|-1.4|1.2|||Mixed Model Repeated Measures||Serum RBP, Week 48|||1.2|-1.4|0.930
74013342|NCT02831673|147577067|OTHER||Mean Difference (Net)|-0.02||||0.009|TWO_SIDED|95.0|-0.04|-0.01|||Mixed Model Repeated Measures||Week 96. Serum Cystatin C.|||-0.01|-0.04|0.009
74013343|NCT02831673|147577068|OTHER||Mean Difference (Net)|-0.01||||0.108|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Week 144. Serum Cystatin C.|||-0.00|-0.03|0.108
74013344|NCT02831673|147577071|OTHER||Mean Difference (Net)|2.2||||0.011|TWO_SIDED|95.0|0.5|4.0|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 24|||4.0|0.5|0.011
74013345|NCT02831673|147577071|OTHER||Mean Difference (Net)|2.8|||<|0.001|TWO_SIDED|95.0|1.2|4.5|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 48|||4.5|1.2|<0.001
74013346|NCT02831673|147577071|OTHER||Mean Difference (Net)|3.2|||<|0.001|TWO_SIDED|95.0|1.6|4.8|||Mixed Model Repeated Measures||GFR-creatinine adjusted, Week 24|||4.8|1.6|<0.001
74013347|NCT02831673|147577071|OTHER||Mean Difference (Net)|3.5|||<|0.001|TWO_SIDED|95.0|2.0|5.1|||Mixed Model Repeated Measures||GFR- creatinine adjusted, Week 48|||5.1|2.0|<0.001
74013348|NCT02831673|147577074|OTHER||Mean Difference (Net)|-3.19|||<|0.001|TWO_SIDED|95.0|-4.62|-1.75|||Mixed Model Repeated Measures||Week 24|||-1.75|-4.62|<0.001
74013349|NCT02831673|147577074|OTHER||Mean Difference (Net)|-3.22|||<|0.001|TWO_SIDED|95.0|-4.54|-1.91|||Mixed Model Repeated Measures||Week 48|||-1.91|-4.54|<0.001
74013350|NCT02831673|147577075|OTHER||Mean Difference (Net)|-3.34|||<|0.001|TWO_SIDED|95.0|-4.96|-1.72|||Mixed Model Repeated Measures||Week 96. Serum or Plasma creatinine|||-1.72|-4.96|<0.001
74094406|NCT00117325|147740167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.113||||0.087|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.02|-0.24|0.087
73879938|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0704|TWO_SIDED|95.0|0.92|7.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.66|0.92|0.0704
74013351|NCT02831673|147577076|OTHER||Mean Difference (Net)|-2.98|||<|0.001|TWO_SIDED|95.0|-4.57|-1.4|||Mixed Model Repeated Measures||Week 144. Serum or Plasma creatinine|||-1.40|-4.57|<0.001
74013352|NCT02831673|147577077|OTHER||Ratio of geometric means|0.915|||<|0.001|TWO_SIDED|95.0|0.887|0.943|||Mixed Model Repeated Measures||Week 24. Serum B2M|||0.943|0.887|<0.001
74013353|NCT02831673|147577077|OTHER||Ratio of geometric means|0.904|||<|0.001|TWO_SIDED|95.0|0.88|0.929|||Mixed Model Repeated Measures||Week 48. Serum B2M|||0.929|0.880|<0.001
74013354|NCT02831673|147577077|OTHER||Ratio of geometric means|0.656||||0.005|TWO_SIDED|95.0|0.491|0.877|||Mixed Model Repeated Measures||Week 24. Urine B2M|||0.877|0.491|0.005
74013355|NCT02831673|147577077|OTHER||Ratio of geometric means|0.672|||<|0.001|TWO_SIDED|95.0|0.551|0.821|||Mixed Model Repeated Measures||Week 48. Urine B2M|||0.821|0.551|<0.001
74013356|NCT02831673|147577077|OTHER||Ratio of geometric means|0.965||||0.575|TWO_SIDED|95.0|0.853|1.092|||Mixed Model Repeated Measures||Week 24. Urine Albumin/Creatinine|||1.092|0.853|0.575
74013357|NCT02831673|147577077|OTHER||Ratio of geometric means|0.891||||0.051|TWO_SIDED|95.0|0.793|1.001|||Mixed Model Repeated Measures||Week 48. Urine Albumin/Creatinine|||1.001|0.793|0.051
74013358|NCT02831673|147577077|OTHER||Ratio of geometric means|0.64|||<|0.001|TWO_SIDED|95.0|0.493|0.831|||Mixed Model Repeated Measures||Week 24. Urine B2M/Urine Creatinine|||0.831|0.493|<0.001
74013359|NCT02831673|147577077|OTHER||Ratio of geometric means|0.695|||<|0.001|TWO_SIDED|95.0|0.576|0.839|||Mixed Model Repeated Measures||Week 48. Urine B2M/Urine Creatinine|||0.839|0.576|<0.001
74013360|NCT02831673|147577077|OTHER||Ratio of geometric means|1.102||||0.099|TWO_SIDED|95.0|0.982|1.237|||Mixed Model Repeated Measures||Week 24. Urine Phosphate|||1.237|0.982|0.099
74013361|NCT02831673|147577077|OTHER||Ratio of geometric means|0.987||||0.816|TWO_SIDED|95.0|0.886|1.1|||Mixed Model Repeated Measures||Week 48. Urine Phosphate|||1.100|0.886|0.816
74013362|NCT02831673|147577077|OTHER||Ratio of geometric means|0.836|||<|0.001|TWO_SIDED|95.0|0.774|0.904|||Mixed Model Repeated Measures||Week 24. Urine Protein/Creatinine|||0.904|0.774|<0.001
74013363|NCT02831673|147577077|OTHER||Ratio of geometric means|0.829|||<|0.001|TWO_SIDED|95.0|0.773|0.888|||Mixed Model Repeated Measures||Week 48. Urine Protein/Creatinine|||0.888|0.773|<0.001
74013364|NCT02831673|147577077|OTHER||Ratio of geometric means|0.871||||0.087|TWO_SIDED|95.0|0.743|1.02|||Mixed Model Repeated Measures||Week 24. Urine RBP 4|||1.020|0.743|0.087
74013365|NCT02831673|147577077|OTHER||Ratio of geometric means|0.748|||<|0.001|TWO_SIDED|95.0|0.644|0.87|||Mixed Model Repeated Measures||Week 48. Urine RBP 4|||0.870|0.644|<0.001
74013366|NCT02831673|147577077|OTHER||Ratio of geometric means|0.828||||0.005|TWO_SIDED|95.0|0.727|0.944|||Mixed Model Repeated Measures||Week 24. Urine RBP 4/Urine Creatinine|||0.944|0.727|0.005
74013367|NCT02831673|147577077|OTHER||Ratio of geometric means|0.765|||<|0.001|TWO_SIDED|95.0|0.677|0.864|||Mixed Model Repeated Measures||Week 48. Urine RBP 4/Urine Creatinine|||0.864|0.677|<0.001
74013368|NCT02831673|147577078|OTHER||Ratio of geometric means|0.839||||0.006|TWO_SIDED|95.0|0.742|0.95|||Mixed Model Repeated Measures||Week 96. Urine Albumin/Creatinine.|||0.950|0.742|0.006
74094407|NCT00117325|147740167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.015|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion||-0.03|-0.30|0.015
74094408|NCT00117325|147740167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.112||||0.106|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.02|-0.25|0.106
74094409|NCT00117325|147740168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.132||||0.048|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rhinorrhea||-0.00|-0.26|0.048
74094410|NCT00117325|147740168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.076|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal congestion||0.01|-0.26|0.076
73879939|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|7.21||||0.004|TWO_SIDED|95.0|1.88|27.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||27.73|1.88|0.0040
74013369|NCT02831673|147577078|OTHER||Ratio of geometric means|0.551|||<|0.001|TWO_SIDED|95.0|0.445|0.682|||Mixed Model Repeated Measures||Week 96. Urine B2M/Urine Creatinine.|||0.682|0.445|<0.001
74013370|NCT02831673|147577078|OTHER||Ratio of geometric means|1.045||||0.467|TWO_SIDED|95.0|0.928|1.175|||Mixed Model Repeated Measures||Week 96. Urine Phosphate.|||1.175|0.928|0.467
74013371|NCT02831673|147577078|OTHER||Ratio of geometric means|0.824|||<|0.001|TWO_SIDED|95.0|0.764|0.889|||Mixed Model Repeated Measures||Week 96. Urine Protein/Creatinine.|||0.889|0.764|<0.001
74013372|NCT02831673|147577078|OTHER||Ratio of geometric means|0.74|||<|0.001|TWO_SIDED|95.0|0.651|0.84|||Mixed Model Repeated Measures||Week 96. Urine RBP 4/Urine Creatinine|||0.840|0.651|<0.001
74013373|NCT02831673|147577079|OTHER||Ratio of geometric means|0.916||||0.205|TWO_SIDED|95.0|0.799|1.05|||Mixed Model Repeated Measures||Week 144. Urine Albumin/Creatinine.|||1.050|0.799|0.205
74013374|NCT02831673|147577079|OTHER||Ratio of geometric means|0.495|||<|0.001|TWO_SIDED|95.0|0.406|0.603|||Mixed Model Repeated Measures||Week 144. Urine B2M/Urine Creatinine.|||0.603|0.406|<0.001
74013375|NCT02831673|147577079|OTHER||Ratio of geometric means|1.089||||0.16|TWO_SIDED|95.0|0.967|1.226|||Mixed Model Repeated Measures||Week 144. Urine Phosphate.|||1.226|0.967|0.160
74013376|NCT02831673|147577079|OTHER||Ratio of geometric means|0.817|||<|0.001|TWO_SIDED|95.0|0.753|0.885|||Mixed Model Repeated Measures||Week 144. Urine Protein/Creatinine.|||0.885|0.753|<0.001
74013377|NCT02831673|147577079|OTHER||Ratio of geometric means|0.679|||<|0.001|TWO_SIDED|95.0|0.607|0.76|||Mixed Model Repeated Measures||Week 144. Urine RBP 4/Urine Creatinine|||0.760|0.607|<0.001
74013378|NCT02831673|147577080|OTHER||Mean Difference (Net)|-2.23|||<|0.001|TWO_SIDED|95.0|-2.75|-1.7|||Mixed Model Repeated Measures||Week 24. Bone ALP|||-1.70|-2.75|<0.001
74013379|NCT02831673|147577080|OTHER||Mean Difference (Net)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.19|-1.98|||Mixed Model Repeated Measures||Week 48. Bone ALP|||-1.98|-3.19|<0.001
74013380|NCT02831673|147577080|OTHER||Mean Difference (Net)|-4.19|||<|0.001|TWO_SIDED|95.0|-5.15|-3.23|||Mixed Model Repeated Measures||Week 28. Serum Osteocalcin|||-3.23|-5.15|<0.001
74013381|NCT02831673|147577080|OTHER||Mean Difference (Net)|-5.23|||<|0.001|TWO_SIDED|95.0|-6.22|-4.23|||Mixed Model Repeated Measures||Week 48. Serum Osteocalcin|||-4.23|-6.22|<0.001
74013382|NCT02831673|147577080|OTHER||Mean Difference (Net)|-13.8|||<|0.001|TWO_SIDED|95.0|-16.5|-11.1|||Mixed Model Repeated Measures||Week 24. Serum PINP|||-11.1|-16.5|<0.001
74013383|NCT02831673|147577080|OTHER||Mean Difference (Net)|-12.6|||<|0.001|TWO_SIDED|95.0|-15.0|-10.3|||Mixed Model Repeated Measures||Week 48. Serum PINP|||-10.3|-15.0|<0.001
74013384|NCT02831673|147577080|OTHER||Mean Difference (Net)|-0.1628|||<|0.001|TWO_SIDED|95.0|-0.2015|-0.1241|||Mixed Model Repeated Measures||Week 24. CTX-1|||-0.1241|-0.2015|<0.001
74013385|NCT02831673|147577080|OTHER||Mean Difference (Net)|-0.2015|||<|0.001|TWO_SIDED|95.0|-0.246|-0.1569|||Mixed Model Repeated Measures||Week 48. CTX-1|||-0.1569|-0.2460|<0.001
74013386|NCT02831673|147577081|OTHER||Mean Difference (Net)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.63|-1.5|||Mixed Model Repeated Measures||Week 96, Bone ALP|||-1.50|-2.63|<0.001
74013387|NCT02831673|147577081|OTHER||Mean Difference (Net)|-4.17|||<|0.001|TWO_SIDED|95.0|-5.2|-3.14|||Mixed Model Repeated Measures||Week 96, Serum Osteocalcin|||-3.14|-5.20|<0.001
74013388|NCT02831673|147577081|OTHER||Mean Difference (Net)|-13.3|||<|0.001|TWO_SIDED|95.0|-17.6|-8.9|||Mixed Model Repeated Measures||Week 96, Serum PINP|||-8.9|-17.6|<0.001
74013389|NCT02831673|147577081|OTHER||Mean Difference (Net)|-0.1592|||<|0.001|TWO_SIDED|95.0|-0.208|-0.1104|||Mixed Model Repeated Measures||Week 96, CTX-1|||-0.1104|-0.2080|<0.001
74013390|NCT02831673|147577082|OTHER||Mean Difference (Net)|-1.68|||<|0.001|TWO_SIDED|95.0|-2.23|-1.14|||Mixed Model Repeated Measures||Week 144, Bone ALP|||-1.14|-2.23|<0.001
74013391|NCT02831673|147577082|OTHER||Mean Difference (Net)|-2.91|||<|0.001|TWO_SIDED|95.0|-4.0|-1.83|||Mixed Model Repeated Measures||Week 144, Serum Osteocalcin|||-1.83|-4.00|<0.001
74094411|NCT00117325|147740168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093||||0.164|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg for post-nasal drip||0.04|-0.22|0.164
74094412|NCT00117325|147740169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096||||0.136|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.03|-0.22|0.136
74094413|NCT00117325|147740169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.1||95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion||0.02|-0.24|0.100
74013392|NCT02831673|147577082|OTHER||Mean Difference (Net)|-9.2|||<|0.001|TWO_SIDED|95.0|-12.3|-6.2|||Mixed Model Repeated Measures||Week 144, Serum PINP|||-6.2|-12.3|<0.001
74013393|NCT02831673|147577082|OTHER||Mean Difference (Net)|-0.1414|||<|0.001|TWO_SIDED|95.0|-0.1771|-0.1056|||Mixed Model Repeated Measures||Week 144, CTX-1|||-0.1056|-0.1771|<0.001
74013394|NCT02831673|147577083|OTHER||Mean Difference (Net)|-6.5|||<|0.001|TWO_SIDED|95.0|-9.9|-3.0|||Mixed Model Repeated Measures||Week 24|||-3.0|-9.9|<0.001
74013395|NCT02831673|147577083|OTHER||Mean Difference (Net)|-6.2|||<|0.001|TWO_SIDED|95.0|-9.0|-3.4|||Mixed Model Repeated Measures||Week 48|||-3.4|-9.0|<0.001
74013396|NCT02831673|147577084|OTHER||Mean Difference (Net)|-2.9||||0.048|TWO_SIDED|95.0|-5.8|0.0|||Mixed Model Repeated Measures||Week 96|||0.0|-5.8|0.048
74013397|NCT02831673|147577085|OTHER||Mean Difference (Net)|-4.9||||0.004|TWO_SIDED|95.0|-8.3|-1.6|||Mixed Model Repeated Measures||Week 144|||-1.6|-8.3|0.004
74013398|NCT02831673|147577092|OTHER||Difference in percentage|2.0||||0.157|TWO_SIDED|95.0|-0.6|4.6||Fisher's exact p-value.|Fisher Exact||Week 24|||4.6|-0.6|0.157
74013399|NCT02831673|147577092|OTHER||Difference in percentage|1.3||||0.414|TWO_SIDED|95.0|-1.7|4.2||Fisher's exact p-value.|Fisher Exact||Week 48|||4.2|-1.7|0.414
74013400|NCT02831673|147577093|OTHER||Difference in percentage|1.0||||0.562|TWO_SIDED|95.0|-2.1|4.1||Fisher's exact p-value.|Fisher Exact||Week 96|||4.1|-2.1|0.562
74013401|NCT02831673|147577094|OTHER||Difference in percentage|0.9||||0.587|TWO_SIDED|95.0|-2.4|4.3||Fisher's exact p-value.|Fisher Exact||Week 144|||4.3|-2.4|0.587
74013402|NCT02831673|147577099|OTHER||Mean Difference (Net)|19.8|||||TWO_SIDED|95.0|-10.23|49.83|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||49.83|-10.23|
74013403|NCT02831673|147577099|OTHER||Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|-57.07|58.4|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||58.40|-57.07|
74013404|NCT02831673|147577099|OTHER||Mean Difference (Net)|36.84|||||TWO_SIDED|95.0|-55.94|129.63|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||129.63|-55.94|
74042786|NCT01510834|147637353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.78|STANDARD_DEVIATION|7.78|<|0.001|TWO_SIDED|95.0|-5.84|-1.7|||t-test, 2 sided|||||-1.70|-5.84|<.001
74042787|NCT01510834|147637354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_DEVIATION|6.269||0.015|TWO_SIDED|95.0|-3.751|-0.4244|||t-test, 2 sided|||||-.4244|-3.751|.015
74042788|NCT00607919|147637365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
74094414|NCT00117325|147740169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.1|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.02|-0.24|0.100
74094415|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.011|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 1||-0.10|-0.80|0.011
74013405|NCT02831673|147577099|OTHER||Mean Difference (Net)|14.37|||||TWO_SIDED|95.0|-13.38|42.12|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||42.12|-13.38|
74013406|NCT02831673|147577099|OTHER||Mean Difference (Net)|25.14|||||TWO_SIDED|95.0|-9.56|59.85|||||Age\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||59.85|-9.56|
74013407|NCT02831673|147577099|OTHER||Mean Difference (Net)|-7.82|||||TWO_SIDED|95.0|-55.98|40.34|||||Age 35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||40.34|-55.98|
74013408|NCT02831673|147577099|OTHER||Mean Difference (Net)|29.45|||||TWO_SIDED|95.0|-55.47|114.38|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||114.38|-55.47|
74013409|NCT02831673|147577099|OTHER||Mean Difference (Net)|17.67|||||TWO_SIDED|95.0|-49.89|85.23|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||85.23|-49.89|
74013410|NCT02831673|147577099|OTHER||Mean Difference (Net)|15.16|||||TWO_SIDED|95.0|-13.9|44.21|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||44.21|-13.90|
74013411|NCT02831673|147577099|OTHER||Mean Difference (Net)|22.51|||||TWO_SIDED|95.0|-9.52|54.54|||||Race group white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||54.54|-9.52|
74013412|NCT02831673|147577099|OTHER||Mean Difference (Net)|-26.67|||||TWO_SIDED|95.0|-110.64|57.3|||||Race group African Am/African H.. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||57.30|-110.64|
74042789|NCT00527072|147637414|SUPERIORITY_OR_OTHER||Proportion|0.654||||0.05|TWO_SIDED|95.0|0.586|0.718|||exact binomial distribution|||null hypothesis H0: proportion = 0.30||0.718|0.586|0.05
74042790|NCT00527072|147637415|SUPERIORITY_OR_OTHER||proportion|0.791||||0.05|TWO_SIDED|95.0|0.73|0.844|||exact binomial distribution|||||0.844|0.730|0.05
74042791|NCT00527072|147637416|SUPERIORITY_OR_OTHER||proportion|0.646||||0.05|TWO_SIDED|95.0|0.577|0.711|||exact binomial distribution|||||0.711|0.577|0.05
74042792|NCT02007252|147637417|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.1037|||||||ANCOVA|||Month 3||||= 0.1037
74042793|NCT02007252|147637417|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.4806|||||||ANCOVA|||Month 12||||= 0.4806
74042794|NCT02657434|147637418|OTHER|Unstratified Analysis|Hazard Ratio, log|0.562|||<|0.0001|TWO_SIDED|95.0|0.471|0.671|||Log Rank|||||0.671|0.471|<0.0001
74042795|NCT02657434|147637419|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.866||||0.1559|TWO_SIDED|95.0|0.709|1.056|||Log Rank|||||1.056|0.709|0.1559
74094416|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.325||||0.089|TWO_SIDED|95.0|-0.7|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 2||0.05|-0.70|0.089
74094417|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.393||||0.052|TWO_SIDED|95.0|-0.79|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 3||0.00|-0.79|0.052
74094418|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262||||0.187|TWO_SIDED|95.0|-0.65|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 4||0.13|-0.65|0.187
74094419|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.298||||0.164|TWO_SIDED|95.0|-0.72|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 5||0.12|-0.72|0.164
74094420|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.573||||0.008|TWO_SIDED|95.0|-1.0|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 6||-0.15|-1.00|0.008
74094421|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.376||||0.082|TWO_SIDED|95.0|-0.8|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 7||0.05|-0.80|0.082
74094422|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.296|TWO_SIDED|95.0|-0.67|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 8||0.20|-0.67|0.296
74094423|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.191||||0.383|TWO_SIDED|95.0|-0.62|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 9||0.24|-0.62|0.383
74094424|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.464||||0.048|TWO_SIDED|95.0|-0.92|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 10||-0.00|-0.92|0.048
74094425|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.172||||0.469|TWO_SIDED|95.0|-0.64|0.29|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 11||0.29|-0.64|0.469
74094426|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.151|TWO_SIDED|95.0|-0.8|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 12||0.12|-0.80|0.151
73888015|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|27.5||||0.171|TWO_SIDED|95.0|-12.0|67.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.1|-12.0|0.1710
74042796|NCT02657434|147637419|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.864||||0.1546|TWO_SIDED|95.0|0.707|1.056|||Log Rank|||||1.056|0.707|0.1546
74042797|NCT02657434|147637420|SUPERIORITY||Difference in event free rate|4.68||||0.2606|TWO_SIDED|95.0|-3.47|12.83|||z test|||||12.83|-3.47|0.2606
74042798|NCT02657434|147637421|SUPERIORITY||Difference in Event Free Rate|5.12||||0.209|TWO_SIDED|95.0|-2.87|13.11|||Z-test|||||13.11|-2.87|0.2090
74042799|NCT02657434|147637422|SUPERIORITY||Difference in response rate|14.3||||0.0005|TWO_SIDED|95.0|5.9|22.7|||Cochran-Mantel-Haenszel|||||22.7|5.9|0.0005
74042800|NCT02657434|147637423|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0024|TWO_SIDED|95.0|0.45|0.85|||Log Rank|||||0.85|0.45|0.0024
74042801|NCT02001688|147637433|SUPERIORITY|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)|||||||0.0005
74042802|NCT02001688|147637433|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.020
74042803|NCT02001688|147637433|SUPERIORITY|||||||0.0192|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.0192
74042804|NCT02001688|147637434|SUPERIORITY|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)|p-value of Stratified Wilcoxon test||||||0.0005
74094427|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.344||||0.145|TWO_SIDED|95.0|-0.81|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 13||0.12|-0.81|0.145
74094428|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.235||||0.297|TWO_SIDED|95.0|-0.68|0.21|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 14||0.21|-0.68|0.297
74094429|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.094|TWO_SIDED|95.0|-0.82|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 15||0.07|-0.82|0.094
74094430|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.064|TWO_SIDED|95.0|-0.89|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 16||0.03|-0.89|0.064
74094431|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.563||||0.019|TWO_SIDED|95.0|-1.03|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 17||-0.09|-1.03|0.019
74094432|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.457||||0.044|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 18||-0.01|-0.90|0.044
74094433|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.633||||0.007|TWO_SIDED|95.0|-1.09|-0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 19||-0.17|-1.09|0.007
74013413|NCT02831673|147577099|OTHER||Mean Difference (Net)|4.44||||||95.0|-76.18|85.06|||||Race group Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||85.06|-76.18|
74013414|NCT02831673|147577099|OTHER||Mean Difference (Net)|24.96|||||TWO_SIDED|95.0|-60.68|110.59|||||Race group Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||110.59|-60.68|
74013415|NCT02831673|147577100|OTHER||Mean Difference (Net)|7.6|||||TWO_SIDED|95.0|-24.6|39.8|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.|||39.8|-24.6|
74013416|NCT02831673|147577100|OTHER||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-59.8|65.9|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.|||65.9|-59.8|
74013417|NCT02831673|147577100|OTHER||Mean Difference (Net)|22.6|||||TWO_SIDED|95.0|-78.3|123.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||123.5|-78.3|
74013418|NCT02831673|147577100|OTHER||Mean Difference (Net)|5.2|||||TWO_SIDED|95.0|-24.7|35.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||35.1|-24.7|
74013419|NCT02831673|147577100|OTHER||Mean Difference (Net)|8.4|||||TWO_SIDED|95.0|-29.1|45.9|||||Age\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||45.9|-29.1|
74013420|NCT02831673|147577100|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-53.9|48.9|||||Age 35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||48.9|-53.9|
73879940|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.04||||0.1625|TWO_SIDED|95.0|0.75|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.55|0.75|0.1625
73879941|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0093|TWO_SIDED|95.0|1.46|14.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||14.50|1.46|0.0093
74013421|NCT02831673|147577100|OTHER||Mean Difference (Net)|17.7|||||TWO_SIDED|95.0|-74.6|110.1|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||110.1|-74.6|
74013422|NCT02831673|147577100|OTHER||Mean Difference (Net)|10.4|||||TWO_SIDED|95.0|-62.3|83.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||83.1|-62.3|
74013423|NCT02831673|147577100|OTHER||Mean Difference (Net)|5.6|||||TWO_SIDED|95.0|-25.6|36.9|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||36.9|-25.6|
74013424|NCT02831673|147577100|OTHER||Mean Difference (Net)|6.3|||||TWO_SIDED|95.0|-28.2|40.9|||||Race group white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||40.9|-28.2|
74042805|NCT02001688|147637434|SUPERIORITY|||||||0.0193|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.0193
74094434|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222||||0.348|TWO_SIDED|95.0|-0.69|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 20||0.24|-0.69|0.348
74013425|NCT02831673|147577100|OTHER||Mean Difference (Net)|-30.2|||||TWO_SIDED|95.0|-122.7|62.4|||||Race group African Am/African H.. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||62.4|-122.7|
74013426|NCT02831673|147577100|OTHER||Mean Difference (Net)|49.2|||||TWO_SIDED|95.0|-36.3|134.7|||||Race group Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||134.7|-36.3|
74013427|NCT02831673|147577100|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-94.7|89.7|||||Race group Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||89.7|-94.7|
74042806|NCT02001688|147637434|SUPERIORITY|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.2485
74042807|NCT02001688|147637435|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg,Kamada-AAT for Inhalation, 160mg and placebo)||||||<0.0001
74042808|NCT02001688|147637436|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg, Kamada-AAT for Inhalation, 160mg and placebo)||||||<0.0001
74094435|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.281||||0.243|TWO_SIDED|95.0|-0.76|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 21||0.19|-0.76|0.243
74094436|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.595||||0.014|TWO_SIDED|95.0|-1.07|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 22||-0.12|-1.07|0.014
74013428|NCT02831673|147577101|OTHER||Mean Difference (Net)|1.9|||||TWO_SIDED|95.0|-34.5|38.2|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||38.2|-34.5|
73879942|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|4.44||||0.0103|TWO_SIDED|95.0|1.42|13.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.87|1.42|0.0103
74042809|NCT01989754|147637444|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.57|0.73|||Cox proportional hazard method|||||0.73|0.57|<.0001
73879943|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.89||||0.1965|TWO_SIDED|95.0|0.72|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.95|0.72|0.1965
73879944|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0549|TWO_SIDED|95.0|0.98|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.42|0.98|0.0549
73879945|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0503|TWO_SIDED|95.0|1.0|9.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.09|1.00|0.0503
73879946|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|7.03||||0.0046|TWO_SIDED|95.0|1.82|27.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||27.10|1.82|0.0046
73879947|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.46||||0.0866|TWO_SIDED|95.0|0.88|6.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.88|0.88|0.0866
73879948|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|5.96||||0.0045|TWO_SIDED|95.0|1.74|20.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||20.40|1.74|0.0045
73879949|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|3.59||||0.0207|TWO_SIDED|95.0|1.22|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.62|1.22|0.0207
73879950|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2127|TWO_SIDED|95.0|0.7|4.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.91|0.70|0.2127
73879951|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.04||||0.1521|TWO_SIDED|95.0|0.77|5.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.43|0.77|0.1521
73879952|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|5.12||||0.0098|TWO_SIDED|95.0|1.48|17.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.70|1.48|0.0098
73879953|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|7.08||||0.0047|TWO_SIDED|95.0|1.82|27.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||27.50|1.82|0.0047
73879954|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1817|TWO_SIDED|95.0|0.72|5.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.51|0.72|0.1817
73879955|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0042|TWO_SIDED|95.0|1.77|20.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.95|1.77|0.0042
73879956|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0039|TWO_SIDED|95.0|1.78|20.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.74|1.78|0.0039
74013429|NCT02831673|147577101|OTHER||Mean Difference (Net)|40.1|||||TWO_SIDED|95.0|-31.2|111.5|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||111.5|-31.2|
74013430|NCT02831673|147577101|OTHER||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-122.3|114.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||114.5|-122.3|
74042810|NCT01989754|147637445|SUPERIORITY||Hazard Ratio (HR)|0.72|||=|0.0148|TWO_SIDED|95.0|0.55|0.94|||Stratified Cox proportional hazard|||||0.94|0.55|=0.0148
74042811|NCT01989754|147637446|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.4067|TWO_SIDED|95.0|0.61|1.22|||Stratified Cox proportional hazard|||||1.22|0.61|=0.4067
74042812|NCT00813917|147637453|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||For this randomized phase II we used a one sided test with a false positive(type I error)rate of 0.20 to assess whether additional studies of the experimental arm are warranted.|Chi-squared|1 sided||Data were compared between treatment groups using Chi Square test.||||0.126
74042813|NCT00792701|147637475|OTHER|Correlation|Correlation Coefficient|0.39||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
74013431|NCT02831673|147577101|OTHER||Mean Difference (Net)|10.8|||||TWO_SIDED|95.0|-22.9|44.5|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||44.5|-22.9|
74013432|NCT02831673|147577101|OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|95.0|-35.0|49.6|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||49.6|-35.0|
74013433|NCT02831673|147577101|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-60.7|55.7|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||55.7|-60.7|
74013434|NCT02831673|147577101|OTHER||Mean Difference (Net)|41.6|||||TWO_SIDED|95.0|-61.2|144.5|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||144.5|-61.2|
74013435|NCT02831673|147577101|OTHER||Mean Difference (Net)|18.8|||||TWO_SIDED|95.0|-64.2|101.8|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||101.8|-64.2|
74013436|NCT02831673|147577101|OTHER||Mean Difference (Net)|7.8|||||TWO_SIDED|95.0|-27.4|43.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||43.1|-27.4|
74013437|NCT02831673|147577101|OTHER||Mean Difference (Net)|15.2|||||TWO_SIDED|95.0|-23.6|54.0|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||54.0|-23.6|
73879957|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.23||||0.7025|TWO_SIDED|95.0|0.42|3.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.57|0.42|0.7025
73879958|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9599|TWO_SIDED|95.0|0.36|2.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.97|0.36|0.9599
73888016|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0||||0.3362|TWO_SIDED|95.0|-106.7|36.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.7|-106.7|0.3362
74013438|NCT02831673|147577101|OTHER||Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-106.3|103.0|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||103.0|-106.3|
74013439|NCT02831673|147577101|OTHER||Median Difference (Net)|-32.6|||||TWO_SIDED|95.0|-132.2|66.9|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||66.9|-132.2|
74013440|NCT02831673|147577101|OTHER||Mean Difference (Net)|26.1|||||TWO_SIDED|95.0|-77.3|129.5|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||129.5|-77.3|
74013441|NCT02831673|147577102|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-39.2|38.3|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||38.3|-39.2|
74013442|NCT02831673|147577102|OTHER||Mean Difference (Net)|4.7|||||TWO_SIDED|95.0|-69.4|78.8|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||78.8|-69.4|
74013443|NCT02831673|147577102|OTHER||Mean Difference (Net)|17.4|||||TWO_SIDED|95.0|-111.1|145.8|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||145.8|-111.1|
74042814|NCT00792701|147637478|SUPERIORITY_OR_OTHER_LEGACY||Correlation Coefficient|0.39||||0.0003|TWO_SIDED||||||Chi-squared|||Comparing RRM1 levels and ERCC1 levels between all patients.||||.0003
74042815|NCT00563368|147637502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|0.831||0.0009|TWO_SIDED|95.0|1.13|4.39||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.39|1.13|0.0009
74013444|NCT02831673|147577102|OTHER||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-37.2|34.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||34.1|-37.2|
74042816|NCT00563368|147637502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|0.825||0.0001|TWO_SIDED|95.0|1.53|4.77||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.77|1.53|0.0001
74094437|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.474||||0.055|TWO_SIDED|95.0|-0.96|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 23||0.01|-0.96|0.055
73879959|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9671|TWO_SIDED|95.0|0.34|3.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.10|0.34|0.9671
74094438|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.464||||0.062|TWO_SIDED|95.0|-0.95|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 24||0.02|-0.95|0.062
74094439|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.079|TWO_SIDED|95.0|-0.91|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 25||0.05|-0.91|0.079
74094440|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.576||||0.019|TWO_SIDED|95.0|-1.06|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 26||-0.10|-1.06|0.019
74094441|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.056|TWO_SIDED|95.0|-0.97|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 27||0.01|-0.97|0.056
74094442|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.659||||0.018|TWO_SIDED|95.0|-1.2|-0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 28||-0.11|-1.20|0.018
74094443|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222||||0.194|TWO_SIDED|95.0|-0.56|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 1||0.1|-0.56|0.194
74094444|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.263||||0.134|TWO_SIDED|95.0|-0.61|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 2||0.08|-0.61|0.134
74094445|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.091|TWO_SIDED|95.0|-0.67|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 3||0.05|-0.67|0.091
74094446|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.278||||0.131|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 4||0.08|-0.64|0.131
74094447|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.483|TWO_SIDED|95.0|-0.49|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 5||0.23|-0.49|0.483
74094448|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.301||||0.137|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 6||0.10|-0.70|0.137
74094449|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.297||||0.142|TWO_SIDED|95.0|-0.69|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 7||0.10|-0.69|0.142
74094450|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245||||0.22|TWO_SIDED|95.0|-0.64|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 8||0.15|-0.64|0.220
74094451|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.373||||0.081|TWO_SIDED|95.0|-0.79|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 9||0.05|-0.79|0.081
74094452|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.453||||0.034|TWO_SIDED|95.0|-0.87|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 10||-0.04|-0.87|0.034
74094453|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.314||||0.15|TWO_SIDED|95.0|-0.74|0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 11||0.11|-0.74|0.150
74094454|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.333||||0.111|TWO_SIDED|95.0|-0.74|0.08|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 12||0.08|-0.74|0.111
74094455|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.261|TWO_SIDED|95.0|-0.69|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 13||0.19|-0.69|0.261
74094456|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.342||||0.123|TWO_SIDED|95.0|-0.78|0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 14||0.09|-0.78|0.123
74094457|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.415||||0.056|TWO_SIDED|95.0|-0.84|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 15||0.01|-0.84|0.056
74094458|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.566||||0.011|TWO_SIDED|95.0|-1.0|-0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 16||-0.13|-1.00|0.011
73879960|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.26||||0.681|TWO_SIDED|95.0|0.42|3.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.83|0.42|0.6810
73879961|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6346|TWO_SIDED|95.0|0.43|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.04|0.43|0.6346
74042817|NCT00563368|147637502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.49|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|5.86|9.12||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||9.12|5.86|<0.0001
74042818|NCT00563368|147637502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.33|STANDARD_ERROR_OF_MEAN|0.832|<|0.0001|TWO_SIDED|95.0|1.69|4.96||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.96|1.69|<0.0001
74042819|NCT00563368|147637502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|STANDARD_ERROR_OF_MEAN|0.828||0.0003|TWO_SIDED|95.0|1.38|4.63||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.63|1.38|0.0003
74042820|NCT00563368|147637502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.75|STANDARD_ERROR_OF_MEAN|0.831|<|0.0001|TWO_SIDED|95.0|5.11|8.38||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||8.38|5.11|<0.0001
74042821|NCT00563368|147637503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.028|STANDARD_ERROR_OF_MEAN|0.5832||0.014|TWO_SIDED|95.0|1.154|3.563||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.563|1.154|0.0140
74042822|NCT00563368|147637503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.246|STANDARD_ERROR_OF_MEAN|0.6418||0.0046|TWO_SIDED|95.0|1.283|3.932||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.932|1.283|0.0046
74042823|NCT00563368|147637503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.623|STANDARD_ERROR_OF_MEAN|3.644|<|0.0001|TWO_SIDED|95.0|5.424|20.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||20.81|5.424|<0.0001
74042824|NCT00563368|147637503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.568|STANDARD_ERROR_OF_MEAN|0.7391||0.0011|TWO_SIDED|95.0|1.46|4.514||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.514|1.460|0.0011
74042825|NCT00563368|147637503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.166|STANDARD_ERROR_OF_MEAN|0.6158||0.0066|TWO_SIDED|95.0|1.241|3.781||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.781|1.241|0.0066
74042826|NCT00563368|147637503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.063|STANDARD_ERROR_OF_MEAN|3.0857|<|0.0001|TWO_SIDED|95.0|4.65|17.66||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||17.66|4.650|<0.0001
74094459|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.009|TWO_SIDED|95.0|-1.03|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 17||-0.15|-1.03|0.009
74094460|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.301||||0.175|TWO_SIDED|95.0|-0.74|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 18||0.13|-0.74|0.175
74094461|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.449||||0.039|TWO_SIDED|95.0|-0.87|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 19||-0.02|-0.87|0.039
74013445|NCT02831673|147577102|OTHER||Mean Difference (Net)|-18.0|||||TWO_SIDED|95.0|-63.2|27.1|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||27.1|-63.2|
74013446|NCT02831673|147577102|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|-57.0|64.0|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||64.0|-57.0|
74013447|NCT02831673|147577102|OTHER||Mean Difference (Net)|95.2|||||TWO_SIDED|95.0|-14.8|205.2|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||205.2|-14.8|
74013448|NCT02831673|147577102|OTHER||Mean Difference (Net)|24.9|||||TWO_SIDED|95.0|-62.5|112.3|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||112.3|-62.5|
74013449|NCT02831673|147577102|OTHER||Mean Difference (Net)|-4.2|||||TWO_SIDED|95.0|-41.5|33.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||33.1|-41.5|
74013450|NCT02831673|147577102|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-40.6|41.1|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||41.1|-40.6|
74013451|NCT02831673|147577102|OTHER||Mean Difference (Net)|-51.3|||||TWO_SIDED|95.0|-163.6|60.9|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||60.9|-163.6|
74013452|NCT02831673|147577102|OTHER||Median Difference (Net)|-20.1|||||TWO_SIDED|95.0|-125.3|85.0|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction|||85.0|-125.3|
74094462|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.315||||0.152|TWO_SIDED|95.0|-0.75|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 20||0.12|-0.75|0.152
74094463|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.424||||0.063|TWO_SIDED|95.0|-0.87|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 21||0.02|-0.87|0.063
74013453|NCT02831673|147577102|OTHER||Mean Difference (Net)|66.2|||||TWO_SIDED|95.0|-43.7|176.2|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||176.2|-43.7|
74013454|NCT02831673|147577103|OTHER||Mean Difference (Net)|0.0052||||0.302|TWO_SIDED|95.0|-0.0047|0.0152|||MMRM||Week 4. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0152|-0.0047|0.302
74013455|NCT02831673|147577103|OTHER||Mean Difference (Net)|-0.0038||||0.45|TWO_SIDED|95.0|-0.0136|0.006|||MMRM||Week24. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0060|-0.0136|0.450
74013456|NCT02831673|147577103|OTHER||Mean Difference (Net)|0.0004||||0.934|TWO_SIDED|95.0|-0.0098|0.0106|||MMRM||Week48. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0106|-0.0098|0.934
74094464|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.454||||0.044|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 22||-0.01|-0.90|0.044
74094465|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.312||||0.179|TWO_SIDED|95.0|-0.77|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 23||0.14|-0.77|0.179
74094466|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.479||||0.034|TWO_SIDED|95.0|-0.92|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 24||-0.04|-0.92|0.034
74094467|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.157||||0.505|TWO_SIDED|95.0|-0.62|0.31|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 25||0.31|-0.62|0.505
74094468|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.317||||0.186|TWO_SIDED|95.0|-0.79|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 26||0.15|-0.79|0.186
74094469|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.283||||0.234|TWO_SIDED|95.0|-0.75|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 27||0.18|-0.75|0.234
74013457|NCT02831673|147577104|OTHER||Mean Difference (Net)|-0.0012||||0.842|TWO_SIDED|95.0|-0.0132|0.0107|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0107|-0.0132|0.842
74013458|NCT02831673|147577105|OTHER||Mean Difference (Net)|0.0008||||0.879|TWO_SIDED|95.0|-0.0097|0.0113|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0113|-0.0097|0.879
73879962|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7929|TWO_SIDED|95.0|0.38|3.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.57|0.38|0.7929
74013459|NCT02831673|147577106|OTHER||Mean Difference (Net)|1.1||||0.137|TWO_SIDED|95.0|-0.3|2.4|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.4|-0.3|0.137
74013460|NCT02831673|147577106|OTHER||Mean Difference (Net)|0.6||||0.458|TWO_SIDED|95.0|-0.9|2.0|||MMRM||Week24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.0|-0.9|0.458
74042827|NCT01575899|147637516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.629|STANDARD_ERROR_OF_MEAN|3.1526||0.008|TWO_SIDED|95.0|1.28|5.42|||Chi-squared|||||5.42|1.28|0.008
74042828|NCT01575899|147637518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87|STANDARD_ERROR_OF_MEAN|3.2589||0.004|TWO_SIDED|95.0|1.5|10.02|||Chi-squared|||||10.02|1.5|0.004
74042829|NCT03205982|147637526|EQUIVALENCE|If the difference (between treatment and control arm) is greater than the minimal clinically important difference (MCID), we consider the treatment arm is different from the control arm. MCID is calculated as 0.25-0.5\* standard deviation (SD). Conversely, the equivalence margin is the biggest difference (between 2 arms) to be considered no difference between 2 arms. Therefore, the equivalence margin should be smaller than MCID, i.e., it should be smaller than the smallest possible MCID.|Odds Ratio (OR)|0.9943|STANDARD_ERROR_OF_MEAN|0.0005|<|0.0001|TWO_SIDED|95.0|0.993|0.995|||Mixed Models Analysis|generalized linear mixed model with logit link (logistic model)||Compares difference in adherence changes between Intervention and Control arms||0.995|0.993|<0.0001
74042830|NCT01293084|147637550|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.2||||0.62|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.62
74042831|NCT01293084|147637551|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.3||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.32
74042832|NCT02483078|147637605|SUPERIORITY|||||||0.0032|||||||Fisher Exact|The Fisher's Exact test if the count in any cell was less than 5; otherwise Chi-Square test was to be used||||||.0032
74042833|NCT02483078|147637606|SUPERIORITY|||||||0.0377|||||||Fisher Exact|||||||.0377
74042834|NCT02483078|147637607|SUPERIORITY|||||||0.1201|||||||Fisher Exact|||||||.1201
74042835|NCT02483078|147637608|SUPERIORITY|||||||0.0013|||||||ANCOVA|||||||.0013
74042836|NCT02483078|147637612|SUPERIORITY|||||||0.7123|||||||ANCOVA|||The raw and change from baseline in CD4 cell count at the end of the 1-week double blind treatment period was to be summarized by treatment group for the first week during the double-blind treatment phase. For change from baseline summaries, subjects with an undefined change from baseline, because of missing data, were to be excluded.||||.7123
74042837|NCT02483078|147637614|SUPERIORITY|||||||0.0993|||||||Fisher Exact|||||||.0993
74042838|NCT00676208|147637654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.04
74042839|NCT00676208|147637655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.04
74042840|NCT00439725|147637699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.185|STANDARD_ERROR_OF_MEAN|0.3858|<|0.0001||95.0|0.087|0.393||1st test in a hierarchy, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing).||0.393|0.087|< 0.0001
74042841|NCT00439725|147637700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.18|STANDARD_ERROR_OF_MEAN|0.385|<|0.0001||95.0|0.085|0.383||2nd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the 1st test in hierarchy was significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.383|0.085|< 0.0001
74042842|NCT00439725|147637701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.198|STANDARD_ERROR_OF_MEAN|0.3659|<|0.0001||95.0|0.096|0.405||3rd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.405|0.096|< 0.0001
74042843|NCT00439725|147637702|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.278|STANDARD_ERROR_OF_MEAN|0.3274|<|0.0001||95.0|0.146|0.528||4th test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.528|0.146|< 0.0001
74042844|NCT00439725|147637705|SUPERIORITY_OR_OTHER|||||||0.1121||||||No adjustment for multiple comparison.|Log Rank|||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.||||0.1121
74042845|NCT00439725|147637706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.185|STANDARD_ERROR_OF_MEAN|0.4131|<|0.0001||95.0|2.307|11.652||No adjustment for multiple comparison, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment done for treatment-emergent (time window: 2 days)||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.||11.652|2.307|< 0.0001
74042846|NCT00379236|147637720|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|Screening pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.||||||0.008
74094470|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.645||||0.017|TWO_SIDED|95.0|-1.17|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 28||-0.12|-1.17|0.017
74094471|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.095|TWO_SIDED|95.0|-0.7|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 1||0.06|-0.70|0.095
74013461|NCT02831673|147577106|OTHER||Mean Difference (Net)|1.5||||0.031|TWO_SIDED|95.0|0.1|2.8|||MMRM||Week48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.8|0.1|0.031
74013462|NCT02831673|147577107|OTHER||Mean Difference (Net)|1.7||||0.027|TWO_SIDED|95.0|0.2|3.2|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||3.2|0.2|0.027
74013463|NCT02831673|147577108|OTHER||Mean Difference (Net)|2.3||||0.001|TWO_SIDED|95.0|0.9|3.6|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||3.6|0.9|0.001
74013464|NCT03615183|147577123|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.36|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 99.72%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
74042847|NCT00379236|147637721|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is purely nominal|ANCOVA|||||||0.001
74042848|NCT00379236|147637722|SUPERIORITY_OR_OTHER|||||||0.202||95.0|||||Chi-squared|||||||0.202
74042849|NCT00379236|147637723|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Chi-squared|||||||0.047
74042850|NCT00379236|147637724|SUPERIORITY_OR_OTHER|||||||0.618||95.0|||||Chi-squared|||||||0.618
74042851|NCT00379236|147637725|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Chi-squared|||||||0.028
74042852|NCT00379236|147637726|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|Baseline pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.||||||0.002
74042853|NCT00379236|147637737|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
74094472|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.236|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 2||0.15|-0.61|0.236
74042854|NCT04914819|147637742|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.048|TWO_SIDED|95.0|0.04|10.8|||Mixed Models Analysis|||Change in weight among participants who completed final assessment||10.8|0.04|0.048
74042855|NCT04914819|147637743|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.3
74094473|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.255||||0.205|TWO_SIDED|95.0|-0.65|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 3||0.14|-0.65|0.205
74042856|NCT04914819|147637744|SUPERIORITY|||||||0.331|||||||Chi-squared|||||||0.331
74042857|NCT04914819|147637745|SUPERIORITY|||||||0.734|||||||Fisher Exact|||||||0.734
74094474|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.343||||0.084|TWO_SIDED|95.0|-0.73|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 4||0.05|-0.73|0.084
74042858|NCT04038385|147637749|SUPERIORITY||Mean Difference (Net)|-42.87||||0.001|TWO_SIDED|95.0|-65.25|-20.49|||Mixed Models Analysis|||||-20.49|-65.25|0.001
74042859|NCT04038385|147637750|SUPERIORITY||Median Difference (Net)|23.91||||0.031|TWO_SIDED|95.0|2.21|45.62|||Mixed Models Analysis|||||45.62|2.21|0.031
74042860|NCT04038385|147637751|SUPERIORITY||Median Difference (Net)|-0.06||||0.662|TWO_SIDED|95.0|-0.33|0.21|||Mixed Models Analysis|||||0.21|-0.33|0.662
74042861|NCT04038385|147637752|SUPERIORITY||Mean Difference (Net)|0.28||||0.047|TWO_SIDED|95.0|0.0|0.55|||Mixed Models Analysis|||||0.55|0.00|0.047
74042862|NCT04038385|147637753|SUPERIORITY||Odds Ratio (OR)|17.39|||<|0.01|TWO_SIDED|95.0|8.64|35.02|||Regression, Logistic|||||35.02|8.64|<0.01
74042863|NCT04038385|147637754|SUPERIORITY||Odds Ratio (OR)|3.9||||0.056|TWO_SIDED|95.0|1.0|16.1|||Mixed Models Analysis|||||16.1|1.0|0.056
74042864|NCT04038385|147637755|SUPERIORITY||Odds Ratio (OR)|4.0||||0.05|TWO_SIDED|95.0|1.0|16.3|||Mixed Models Analysis|||||16.3|1.0|0.050
74042865|NCT04038385|147637756|SUPERIORITY||Mean Difference (Net)|-1.7||||0.001|TWO_SIDED|95.0|-2.5|-1.0|||Mixed Models Analysis|||||-1.0|-2.5|0.001
74042866|NCT04038385|147637757|SUPERIORITY||Median Difference (Net)|-0.7||||0.082|TWO_SIDED|95.0|-1.4|0.1|||Mixed Models Analysis|||||0.1|-1.4|0.082
74042867|NCT04038385|147637758|SUPERIORITY||Mean Difference (Net)|-1.5||||0.001|TWO_SIDED|95.0|-2.2|-0.8|||Mixed Models Analysis|||||-0.8|-2.2|0.001
74042868|NCT04038385|147637759|SUPERIORITY||Median Difference (Net)|-0.7||||0.039|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|||||-0.0|-1.4|0.039
74042869|NCT04038385|147637760|SUPERIORITY||Mean Difference (Net)|0.0||||0.962|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.962
74094475|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.146||||0.475|TWO_SIDED|95.0|-0.55|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 5||0.26|-0.55|0.475
74094476|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.296||||0.178|TWO_SIDED|95.0|-0.73|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 6||0.14|-0.73|0.178
73879963|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8188|TWO_SIDED|95.0|0.39|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.28|0.39|0.8188
74013465|NCT03615183|147577123|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.63|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 99.86%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
74013466|NCT03615183|147577123|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.92|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 9.42%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
74013467|NCT01977781|147577140|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||Only the statistical analysis results for burning sensation at 10 weeks are reported below as they where the only tolerability results found to be significantly different between the two arms. All other tolerability measures were found to be the same between the two groups.||||0.0019
74013468|NCT02104583|147577147|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|1.52||||0.152|TWO_SIDED|95.0|0.86|2.71|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or rest of world (ROW)\].||2.71|0.86|0.152
74013469|NCT02104583|147577147|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|0.82||||0.662|TWO_SIDED|95.0|0.34|1.97|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or ROW\].||1.97|0.34|0.662
74013470|NCT02104583|147577147|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|1.24||||0.618|TWO_SIDED|95.0|0.54|2.86|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or ROW.||2.86|0.54|0.618
74013471|NCT00960661|147577230|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was concluded if the upper limit of the 95% confidence interval (CI) for the treatment contrast (BET minus BBT) at week 30 was less than the non inferiority margin.|Mean Difference (Final Values)|-0.04||||0.6273|TWO_SIDED|95.0|-0.18|0.11||The primary mixed-model repeated measures (MMRM) model included baseline HbA1c as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Mixed model repeated measures|||The primary objective is to test the hypothesis that BET is non inferior to BBT with respect to change in HbA1c from baseline to Week 30.||0.11|-0.18|0.6273
73879964|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8226|TWO_SIDED|95.0|0.3|2.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.60|0.30|0.8226
74013472|NCT00847912|147577259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Log Rank|||||||0.93
74013473|NCT00847912|147577260|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.93|TWO_SIDED|95.0|0.82|1.24|||Regression, Cox|||||1.24|0.82|0.93
74013474|NCT03070470|147577261|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|1.2|||||TWO_SIDED|90.0|-9.5|12.0||The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.|Mixed Models Analysis|||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||12.0|-9.5|
74013475|NCT03070470|147577261|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.6|||||TWO_SIDED|90.0|-11.4|6.1|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||6.1|-11.4|
74042870|NCT04038385|147637761|SUPERIORITY||Mean Difference (Net)|-0.2||||0.277|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|.277
74042871|NCT04038385|147637762|SUPERIORITY||Median Difference (Net)|-0.4||||0.155|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis|||||0.2|-1.0|0.155
74042872|NCT04038385|147637763|SUPERIORITY||Mean Difference (Net)|0.1||||0.74|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||||0.7|-0.5|0.740
74042873|NCT04038385|147637764|SUPERIORITY||Median Difference (Net)|-0.2||||0.122|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|.122
74042874|NCT04038385|147637765|SUPERIORITY||Mean Difference (Net)|-0.2||||0.177|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|.177
74042875|NCT04038385|147637766|SUPERIORITY||Median Difference (Net)|0.1||||0.514|TWO_SIDED|95.0|-0.3|0.5|||Mixed Models Analysis|||||0.5|-0.3|0.514
74042876|NCT04038385|147637767|SUPERIORITY||Median Difference (Net)|0.2||||0.335|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.335
74013476|NCT03070470|147577261|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.9|||||TWO_SIDED|90.0|-14.6|8.8|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||8.8|-14.6|
74094477|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.406||||0.071|TWO_SIDED|95.0|-0.85|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 7||0.04|-0.85|0.071
73879965|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9088|TWO_SIDED|95.0|0.32|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.72|0.32|0.9088
74013477|NCT03070470|147577262|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|30.7|||||TWO_SIDED|90.0|22.6|38.9|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% CI to be ≥10 msec for the projected placebo-corrected change from baseline QTc effect at the peak plasma level on Day 1 using a linear mixed-effects exposure response model.||38.9|22.6|
74013478|NCT01732796|147577264|SUPERIORITY_OR_OTHER||Adjusted response rate|81.4|||<|0.0001|TWO_SIDED|95.0|76.6|86.2|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).||86.2|76.6|<0.0001
74013479|NCT01732796|147577264|SUPERIORITY_OR_OTHER||Adjusted response rate|71.7||||0.3989|TWO_SIDED|95.0|66.1|77.4|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).||77.4|66.1|0.3989
74013480|NCT01732796|147577265|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|10.8||||0.004|TWO_SIDED|95.0|2.8|18.8|||z-test|based on two sample z-test with continuity correction for variance.||||18.8|2.8|0.0040
74042877|NCT04038385|147637768|SUPERIORITY||Mean Difference (Net)|0.1||||0.75|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||||0.6|-0.4|0.750
74042878|NCT04038385|147637769|SUPERIORITY||Mean Difference (Net)|-0.2||||0.455|TWO_SIDED|95.0|-0.7|0.3|||Mixed Models Analysis|||||0.3|-0.7|0.455
74042879|NCT04038385|147637770|SUPERIORITY||Mean Difference (Net)|0.9||||0.053|TWO_SIDED|95.0|0.0|1.8|||Mixed Models Analysis|||||1.8|-0.0|0.053
74094478|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.621|TWO_SIDED|95.0|-0.55|0.33|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 8||0.33|-0.55|0.621
74094479|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.206||||0.372|TWO_SIDED|95.0|-0.66|0.25|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 9||0.25|-0.66|0.372
74042880|NCT04038385|147637771|SUPERIORITY||Mean Difference (Net)|0.0||||0.986|TWO_SIDED|95.0|-0.9|0.9|||Mixed Models Analysis|||||0.9|-0.9|.986
74042881|NCT04038385|147637772|SUPERIORITY||Odds Ratio (OR)|1.1||||0.81|TWO_SIDED|95.0|0.6|2.2|||Mixed Models Analysis|||||2.2|0.6|0.810
74042882|NCT04038385|147637773|SUPERIORITY||Odds Ratio (OR)|0.8||||0.591|TWO_SIDED|95.0|0.4|1.7|||Mixed Models Analysis|||||1.7|0.4|0.591
74042883|NCT01628393|147637849|SUPERIORITY||||||<|0.0001||||||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
74042884|NCT01628393|147637849|SUPERIORITY||||||<|0.0001||||||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
74042885|NCT01628393|147637850|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
74042886|NCT01628393|147637850|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
74042887|NCT01628393|147637851|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
74042888|NCT01628393|147637851|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
74042889|NCT01628393|147637852|SUPERIORITY||Rate Ratio|0.47||||0.0531|TWO_SIDED|95.0|0.22|1.01|||Poisson regression model|Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.|Rate ratio = Ozanimod / Placebo|||1.01|0.22|0.0531
74094480|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.452||||0.046|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 10||-0.01|-0.90|0.046
74094481|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.302||||0.183|TWO_SIDED|95.0|-0.75|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 11||0.14|-0.75|0.183
74094482|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.226||||0.32|TWO_SIDED|95.0|-0.67|0.22|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 12||0.22|-0.67|0.320
74094483|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.188||||0.431|TWO_SIDED|95.0|-0.66|0.28|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 13||0.28|-0.66|0.431
74094484|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.299||||0.191|TWO_SIDED|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 14||0.15|-0.75|0.191
73879966|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6189|TWO_SIDED|95.0|0.24|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.35|0.24|0.6189
73879967|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6463|TWO_SIDED|95.0|0.42|4.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.03|0.42|0.6463
73879968|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.47||||0.506|TWO_SIDED|95.0|0.47|4.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.54|0.47|0.5060
74094485|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.475||||0.043|TWO_SIDED|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 15||-0.02|-0.94|0.043
74094486|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.619||||0.009|TWO_SIDED|95.0|-1.08|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 16||-0.16|-1.08|0.009
74094487|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.495||||0.04|TWO_SIDED|95.0|-0.97|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 17||-0.02|-0.97|0.040
74094488|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262||||0.249|TWO_SIDED|95.0|-0.71|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 18||0.18|-0.71|0.249
74094489|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.536||||0.023|TWO_SIDED|95.0|-1.0|-0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 19||-0.07|-1.00|0.023
74094490|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.321|TWO_SIDED|95.0|-0.71|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 20||0.23|-0.71|0.321
74094491|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.568||||0.019|TWO_SIDED|95.0|-1.04|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 21||-0.09|-1.04|0.019
74094492|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.419||||0.092|TWO_SIDED|95.0|-0.91|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 22||0.07|-0.91|0.092
74094493|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.206||||0.404|TWO_SIDED|95.0|-0.69|0.28|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 23||0.28|-0.69|0.404
74094494|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.546||||0.027|TWO_SIDED|95.0|-1.03|-0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 24||-0.06|-1.03|0.027
74094495|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.227||||0.357|TWO_SIDED|95.0|-0.71|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 25||0.26|-0.71|0.357
74094496|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.403||||0.114|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 26||0.10|-0.90|0.114
74094497|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.307||||0.228|TWO_SIDED|95.0|-0.81|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 27||0.19|-0.81|0.228
74094498|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.725||||0.012|TWO_SIDED|95.0|-1.29|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 28||-0.16|-1.29|0.012
74094499|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093||||0.643|TWO_SIDED|95.0|-0.49|0.3|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 1||0.30|-0.49|0.643
74094500|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.279||||0.15|TWO_SIDED|95.0|-0.66|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 2||0.10|-0.66|0.150
73879969|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3842|TWO_SIDED|95.0|0.53|5.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.31|0.53|0.3842
74013481|NCT01732796|147577266|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|6.0||||0.0575|TWO_SIDED|95.0|-1.5|13.5|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response||13.5|-1.5|0.0575
74013482|NCT01732796|147577267|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|9.9||||0.0089|TWO_SIDED|95.0|1.7|18.1|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response||18.1|1.7|0.0089
74042890|NCT01628393|147637852|SUPERIORITY||Rate Ratio|0.69||||0.2714|TWO_SIDED|95.0|0.36|1.34|||Poisson regression model|Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.|Rate ratio = Ozanimod / Placebo|||1.34|0.36|0.2714
74042891|NCT02980692|147637877|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
74042892|NCT02980692|147637877|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||||||0.0006
74042893|NCT02980692|147637877|SUPERIORITY|||||||0.0088|||||||Cochran-Mantel-Haenszel|||||||0.0088
74042894|NCT02980692|147637877|SUPERIORITY|||||||0.0041|||||||Cochran-Mantel-Haenszel|||||||0.0041
74042895|NCT02980692|147637878|SUPERIORITY||% response rate|92.54|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|86.24|98.83||||||||98.83|86.24|
74042896|NCT02980692|147637878|SUPERIORITY||% response rate|89.06|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|81.42|96.71||||||||96.71|81.42|
74042897|NCT02980692|147637878|SUPERIORITY||% response rate|86.67|STANDARD_ERROR_OF_MEAN|4.39|||TWO_SIDED|95.0|78.07|95.27||||||||95.27|78.07|
74042898|NCT02980692|147637878|SUPERIORITY||% response rate|81.33|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|72.52|90.15||||||||90.15|72.52|
74042899|NCT02980692|147637878|SUPERIORITY||% response rate|81.33|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|72.52|90.15||||||||90.15|72.52|
74042900|NCT02980692|147637879|SUPERIORITY||% response rate|79.1|STANDARD_ERROR_OF_MEAN|4.97|||TWO_SIDED|95.0|69.37|88.84||||||||88.84|69.37|
74042901|NCT02980692|147637879|SUPERIORITY||% response rate|75.0|STANDARD_ERROR_OF_MEAN|5.41|||TWO_SIDED|95.0|64.39|85.61||||||||85.61|64.39|
74042902|NCT02980692|147637879|SUPERIORITY||% response rate|72.13|STANDARD_ERROR_OF_MEAN|5.74|||TWO_SIDED|95.0|60.88|83.38||||||||83.38|60.88|
74094501|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.291||||0.162|TWO_SIDED|95.0|-0.7|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 3||0.12|-0.70|0.162
74013483|NCT02324920|147577268|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.001|TWO_SIDED|95.0|0.11|0.46|||Regression, Cox||||Additional models were implemented to control for country and investigational sites effect on primary endpoint.|0.46|0.11|<0.001
74013484|NCT02324920|147577269|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.002|TWO_SIDED|95.0|0.27|0.75|||Regression, Cox|||||0.75|0.27|0.002
74042903|NCT02980692|147637879|SUPERIORITY||% response rate|68.0|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|95.0|57.44|78.56||||||||78.56|57.44|
74042904|NCT02980692|147637879|SUPERIORITY||% response rate|62.67|STANDARD_ERROR_OF_MEAN|5.59|||TWO_SIDED|95.0|51.72|73.61||||||||73.61|51.72|
74042905|NCT02980692|147637880|SUPERIORITY||% response rate|58.21|STANDARD_ERROR_OF_MEAN|6.03|||TWO_SIDED|95.0|46.4|70.02||||||||70.02|46.40|
74042906|NCT02980692|147637880|SUPERIORITY||% response rate|48.44|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|36.19|60.68||||||||60.68|36.19|
74042907|NCT02980692|147637880|SUPERIORITY||% response rate|39.34|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|27.09|51.6||||||||51.60|27.09|
74042908|NCT02980692|147637880|SUPERIORITY||% response rate|40.0|STANDARD_ERROR_OF_MEAN|5.66|||TWO_SIDED|95.0|28.91|51.09||||||||51.09|28.91|
74042909|NCT02980692|147637880|SUPERIORITY||% response rate|37.33|STANDARD_ERROR_OF_MEAN|5.59|||TWO_SIDED|95.0|26.39|48.28||||||||48.28|26.39|
74042910|NCT02980692|147637881|SUPERIORITY|||||||0.085|||||||Cochran-Mantel-Haenszel|||||||0.0850
74042911|NCT02980692|147637881|SUPERIORITY|||||||0.0234|||||||Cochran-Mantel-Haenszel|||||||0.0234
74042912|NCT02980692|147637881|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|||||||0.0140
74042913|NCT02980692|147637881|SUPERIORITY|||||||0.0731|||||||Cochran-Mantel-Haenszel|||||||0.0731
74042914|NCT02980692|147637882|SUPERIORITY||Mean Difference (Net)|-12.3|STANDARD_DEVIATION|11.47|||TWO_SIDED|||||||||||||
74042915|NCT02980692|147637882|SUPERIORITY||Mean Difference (Net)|-13.7|STANDARD_DEVIATION|11.92|||TWO_SIDED|||||||||||||
74042916|NCT02980692|147637882|SUPERIORITY||Mean Difference (Net)|-16.0|STANDARD_DEVIATION|12.83|||TWO_SIDED|||||||||||||
74042917|NCT02980692|147637882|SUPERIORITY||Mean Difference (Net)|-14.0|STANDARD_DEVIATION|10.65|||TWO_SIDED|||||||||||||
74042918|NCT02980692|147637882|SUPERIORITY||Mean Difference (Net)|-13.9|STANDARD_DEVIATION|12.02|||TWO_SIDED|||||||||||||
74042919|NCT02980692|147637883|SUPERIORITY|||||||0.0111|||||||Cochran-Mantel-Haenszel|||||||0.0111
74042920|NCT02980692|147637883|SUPERIORITY|||||||0.0774|||||||Cochran-Mantel-Haenszel|||||||0.0774
74042921|NCT02980692|147637883|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|||||||0.0190
74042922|NCT02980692|147637883|SUPERIORITY|||||||0.1282|||||||Cochran-Mantel-Haenszel|||||||0.1282
74042923|NCT02980692|147637884|SUPERIORITY||Mean Difference (Net)|-8.7|STANDARD_DEVIATION|6.88|||TWO_SIDED|||||||||||||
74042924|NCT02980692|147637884|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|7.07|||TWO_SIDED|||||||||||||
74042925|NCT02980692|147637884|SUPERIORITY||Mean Difference (Net)|-9.2|STANDARD_DEVIATION|7.62|||TWO_SIDED|||||||||||||
74042926|NCT02980692|147637884|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|5.78|||TWO_SIDED|||||||||||||
74042927|NCT02980692|147637884|SUPERIORITY||Mean Difference (Net)|-9.0|STANDARD_DEVIATION|8.8|||TWO_SIDED|||||||||||||
74042928|NCT02980692|147637885|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
74042929|NCT02980692|147637885|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
74042930|NCT02980692|147637885|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
74042931|NCT02980692|147637885|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
74042932|NCT02980692|147637886|SUPERIORITY||Mean Difference (Net)|-40.0|STANDARD_DEVIATION|17.38|||TWO_SIDED|||||||||||||
74013485|NCT00930761|147577270|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.22||||0.06||95.0|0.99|1.51|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the infant hospital discharge and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.||1.51|0.99|0.06
74013486|NCT00930761|147577271|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21||||0.13||95.0|0.73|5.66|||Chi-squared|||||5.66|0.73|0.13
74013487|NCT00930761|147577272|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.26||||0.03||95.0|1.01|1.57|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the first follow-up visit and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.||1.57|1.01|0.03
74042933|NCT02980692|147637886|SUPERIORITY||Mean Difference (Net)|-44.3|STANDARD_DEVIATION|19.73|||TWO_SIDED|||||||||||||
74013488|NCT00930761|147577273|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.28||||0.09||95.0|0.95|1.71|||Chi-squared|||||1.71|0.95|0.09
74013489|NCT01500278|147577279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||=|0.467|TWO_SIDED|95.0|0.67|1.2||The odds ratio, CI, and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (\<2 years or \>=2 years), and geographic region as factors and age as a covariate.|Regression, Logistic|||||1.20|0.67|=0.467
74013490|NCT01500278|147577280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|||=|0.532|TWO_SIDED|95.0|0.82|1.45||The odds ratio, CI and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (\<2 years or \>=2 years), and geographic region as factors and Baseline DAS28(ESR) and age as covariates.|Regression, Logistic|||||1.45|0.82|=0.532
74042934|NCT02980692|147637886|SUPERIORITY||Mean Difference (Net)|-45.3|STANDARD_DEVIATION|19.84|||TWO_SIDED|||||||||||||
74042935|NCT02980692|147637886|SUPERIORITY||Mean Difference (Net)|-42.7|STANDARD_DEVIATION|19.18|||TWO_SIDED|||||||||||||
74042936|NCT02980692|147637886|SUPERIORITY||Mean Difference (Net)|-42.0|STANDARD_DEVIATION|20.41|||TWO_SIDED|||||||||||||
74042937|NCT02980692|147637887|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
74042938|NCT02980692|147637887|SUPERIORITY|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
74042939|NCT02980692|147637887|SUPERIORITY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||||||0.0011
74042940|NCT02980692|147637887|SUPERIORITY|||||||0.0167|||||||Cochran-Mantel-Haenszel|||||||0.0167
74042941|NCT02980692|147637888|SUPERIORITY||Mean Difference (Net)|-42.2|STANDARD_DEVIATION|22.74|||TWO_SIDED|||||||||||||
73879970|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5021|TWO_SIDED|95.0|0.49|4.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.23|0.49|0.5021
74042942|NCT02980692|147637888|SUPERIORITY||Mean Difference (Net)|-43.8|STANDARD_DEVIATION|24.01|||TWO_SIDED|||||||||||||
74042943|NCT02980692|147637888|SUPERIORITY||Mean Difference (Net)|-38.4|STANDARD_DEVIATION|27.9|||TWO_SIDED|||||||||||||
74042944|NCT02980692|147637888|SUPERIORITY||Mean Difference (Net)|-37.9|STANDARD_DEVIATION|24.65|||TWO_SIDED|||||||||||||
74042945|NCT02980692|147637888|SUPERIORITY||Mean Difference (Net)|-40.5|STANDARD_DEVIATION|28.13|||TWO_SIDED|||||||||||||
74013491|NCT02459795|147577290|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.0|||||TWO_SIDED|90.0|-7.0|12.92|||Yates correction|||||12.92|-7.00|
74042946|NCT02980692|147637889|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
74042947|NCT02980692|147637889|SUPERIORITY|||||||0.0055|||||||Cochran-Mantel-Haenszel|||||||0.0055
74042948|NCT02980692|147637889|SUPERIORITY|||||||0.0039|||||||Cochran-Mantel-Haenszel|||||||0.0039
74042949|NCT02980692|147637889|SUPERIORITY|||||||0.0487|||||||Cochran-Mantel-Haenszel|||||||0.0487
74042950|NCT02980692|147637890|SUPERIORITY||Mean Difference (Net)|-40.7|STANDARD_DEVIATION|21.59|||TWO_SIDED|||||||||||||
74042951|NCT02980692|147637890|SUPERIORITY||Mean Difference (Net)|-42.7|STANDARD_DEVIATION|25.67|||TWO_SIDED|||||||||||||
74042952|NCT02980692|147637890|SUPERIORITY||Mean Difference (Net)|-38.0|STANDARD_DEVIATION|29.26|||TWO_SIDED|||||||||||||
74042953|NCT02980692|147637890|SUPERIORITY||Mean Difference (Net)|-37.6|STANDARD_DEVIATION|26.63|||TWO_SIDED|||||||||||||
74042954|NCT02980692|147637890|SUPERIORITY||Mean Difference (Net)|-41.0|STANDARD_DEVIATION|29.83|||TWO_SIDED|||||||||||||
74042955|NCT02980692|147637891|SUPERIORITY|||||||0.0987|||||||Cochran-Mantel-Haenszel|||||||0.0987
74042956|NCT02980692|147637891|SUPERIORITY|||||||0.036|||||||Cochran-Mantel-Haenszel|||||||0.0360
74042957|NCT02980692|147637891|SUPERIORITY|||||||0.0346|||||||Cochran-Mantel-Haenszel|||||||0.0346
74042958|NCT02980692|147637891|SUPERIORITY|||||||0.4442|||||||Cochran-Mantel-Haenszel|||||||0.4442
74042959|NCT02980692|147637892|SUPERIORITY||Mean Difference (Net)|-0.4869|STANDARD_DEVIATION|0.52093|||TWO_SIDED|||||||||||||
74042960|NCT02980692|147637892|SUPERIORITY||Mean Difference (Net)|-0.543|STANDARD_DEVIATION|0.59145|||TWO_SIDED|||||||||||||
74042961|NCT02980692|147637892|SUPERIORITY||Mean Difference (Net)|-0.4857|STANDARD_DEVIATION|0.56968|||TWO_SIDED|||||||||||||
74042962|NCT02980692|147637892|SUPERIORITY||Mean Difference (Net)|-0.4583|STANDARD_DEVIATION|0.52285|||TWO_SIDED|||||||||||||
74042963|NCT02980692|147637892|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|0.54013|||TWO_SIDED|||||||||||||
74042964|NCT02980692|147637893|SUPERIORITY|||||||0.0064|||||||Cochran-Mantel-Haenszel|||||||0.0064
74042965|NCT02980692|147637893|SUPERIORITY|||||||0.0516|||||||Cochran-Mantel-Haenszel|||||||0.0516
74042966|NCT02980692|147637893|SUPERIORITY|||||||0.0114|||||||Cochran-Mantel-Haenszel|||||||0.0114
74042967|NCT02980692|147637893|SUPERIORITY|||||||0.082|||||||Cochran-Mantel-Haenszel|||||||0.0820
74042968|NCT02980692|147637894|SUPERIORITY||Mean Difference (Net)|-3.43|STANDARD_DEVIATION|12.506|||TWO_SIDED|||||||||||||
74042969|NCT02980692|147637894|SUPERIORITY||Mean Difference (Net)|-3.68|STANDARD_DEVIATION|10.77|||TWO_SIDED|||||||||||||
74013492|NCT01297270|147577328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||30.6|10.7|<0.0001
74013493|NCT01297270|147577328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4||||0.0007|TWO_SIDED|95.0|7.3|27.4|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||27.4|7.3|0.0007
74013494|NCT01297270|147577329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||30.6|10.7|<0.0001
74013495|NCT01297270|147577329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.6||||0.0014|TWO_SIDED|95.0|6.5|26.7|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||26.7|6.5|0.0014
74013496|NCT03882970|147577341|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-0.86|||<|0.001|TWO_SIDED|95.0|-1.0|-0.72|||Mixed Models Analysis|||||-0.72|-1.00|<0.001
74013497|NCT03882970|147577341|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.17|-0.9|||Mixed Models Analysis|||||-0.90|-1.17|<0.001
74013498|NCT03882970|147577342|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.73|-0.45|||Mixed Models Analysis|||||-0.45|-0.73|<0.001
74013499|NCT03882970|147577343|SUPERIORITY||LS Mean Difference|-9.8|||<|0.001|TWO_SIDED|95.0|-10.8|-8.8|||Mixed Models Analysis|||||-8.8|-10.8|<0.001
74013500|NCT03882970|147577343|SUPERIORITY||LS Mean Difference|-13.0|||<|0.001|TWO_SIDED|95.0|-14.0|-11.9|||Mixed Models Analysis|||||-11.9|-14.0|<0.001
74013501|NCT03882970|147577343|SUPERIORITY||LS Mean Difference|-15.2|||<|0.001|TWO_SIDED|95.0|-16.2|-14.2|||Mixed Models Analysis|||||-14.2|-16.2|<0.001
74013502|NCT03882970|147577344|SUPERIORITY||LS Mean Difference|7.5||||0.004|TWO_SIDED|95.0|2.4|12.5|||Mixed Models Analysis|||||12.5|2.4|0.004
74013503|NCT03882970|147577344|SUPERIORITY||LS Mean Difference|0.8||||0.751|TWO_SIDED|95.0|-4.3|5.9|||Mixed Models Analysis|||||5.9|-4.3|0.751
74013504|NCT03882970|147577344|SUPERIORITY||LS Mean Difference|-3.6||||0.168|TWO_SIDED|95.0|-8.7|1.5|||Mixed Models Analysis|||||1.5|-8.7|0.168
74042970|NCT02980692|147637894|SUPERIORITY||Mean Difference (Net)|-6.05|STANDARD_DEVIATION|19.004|||TWO_SIDED|||||||||||||
74042971|NCT02980692|147637894|SUPERIORITY||Mean Difference (Net)|-4.61|STANDARD_DEVIATION|9.508|||TWO_SIDED|||||||||||||
74042972|NCT02980692|147637894|SUPERIORITY||Mean Difference (Net)|-6.75|STANDARD_DEVIATION|19.649|||TWO_SIDED|||||||||||||
74042973|NCT02980692|147637895|SUPERIORITY|||||||0.0351|||||||Cochran-Mantel-Haenszel|||||||0.0351
74042974|NCT02980692|147637895|SUPERIORITY|||||||0.0876|||||||Cochran-Mantel-Haenszel|||||||0.0876
74042975|NCT02980692|147637895|SUPERIORITY|||||||0.0269|||||||Cochran-Mantel-Haenszel|||||||0.0269
74042976|NCT02980692|147637895|SUPERIORITY|||||||0.0185|||||||Cochran-Mantel-Haenszel|||||||0.0185
74013505|NCT03882970|147577345|SUPERIORITY||Odds Ratio (OR)|3.45|||<|0.001|TWO_SIDED|95.0|2.38|5.01|||Regression, Logistic|||||5.01|2.38|<0.001
74013506|NCT03882970|147577345|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|4.55|10.84|||Regression, Logistic|||||10.84|4.55|<0.001
74013507|NCT03882970|147577345|SUPERIORITY||Odds Ratio (OR)|10.79|||<|0.001|TWO_SIDED|95.0|6.65|17.48|||Regression, Logistic|||||17.48|6.65|<0.001
74013508|NCT03882970|147577347|SUPERIORITY||Odds Ratio (OR)|29.78|||<|0.001|TWO_SIDED|95.0|18.35|48.35|||Regression, Logistic|||||48.35|18.35|<0.001
74013509|NCT03882970|147577347|SUPERIORITY||Odds Ratio (OR)|79.88|||<|0.001|TWO_SIDED|95.0|47.56|134.17|||Regression, Logistic|||||134.17|47.56|<0.001
74013510|NCT03882970|147577347|SUPERIORITY||Odds Ratio (OR)|110.77|||<|0.001|TWO_SIDED|95.0|64.73|189.55|||Regression, Logistic|||||189.55|64.73|<0.001
74013511|NCT03882970|147577348|SUPERIORITY||LS Mean Difference|-0.26||||0.096|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||Hyperglycemia||0.05|-0.57|0.096
74013512|NCT03882970|147577348|SUPERIORITY||LS Mean Difference|-0.25||||0.113|TWO_SIDED|95.0|-0.57|0.06|||ANCOVA|||Hyperglycemia||0.06|-0.57|0.113
74013513|NCT03882970|147577348|SUPERIORITY||LS Mean Difference|-0.47||||0.003|TWO_SIDED|95.0|-0.78|-0.16|||ANCOVA|||Hyperglycemia||-0.16|-0.78|0.003
74013514|NCT03882970|147577348|SUPERIORITY||LS Mean Difference|-0.41||||0.014|TWO_SIDED|95.0|-0.74|-0.08|||ANCOVA|||Hypoglycemia||-0.08|-0.74|0.014
74013515|NCT03882970|147577348|SUPERIORITY||LS Mean Difference|-0.18||||0.28|TWO_SIDED|95.0|-0.51|0.15|||ANCOVA|||Hypoglycemia||0.15|-0.51|0.280
74013516|NCT03882970|147577348|SUPERIORITY||LS Mean Difference|-0.26||||0.129|TWO_SIDED|95.0|-0.59|0.07|||ANCOVA|||Hypoglycemia||0.07|-0.59|0.129
74042977|NCT02980692|147637896|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_DEVIATION|19.58|||TWO_SIDED|||||||||||||
74042978|NCT02980692|147637896|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_DEVIATION|15.26|||TWO_SIDED|||||||||||||
74042979|NCT02980692|147637896|SUPERIORITY||Median Difference (Net)|-8.9|STANDARD_DEVIATION|20.48|||TWO_SIDED|||||||||||||
74042980|NCT02980692|147637896|SUPERIORITY||Mean Difference (Net)|-9.7|STANDARD_DEVIATION|19.02|||TWO_SIDED|||||||||||||
74042981|NCT02980692|147637896|SUPERIORITY||Mean Difference (Net)|-9.2|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||||||||||
74042982|NCT02980692|147637897|SUPERIORITY||Proportion with Adjustment of Background|1.27|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|0.0|3.73||||||||3.73|0.00|
74042983|NCT02980692|147637897|SUPERIORITY||Proportion with Adjustment of Background|1.3|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|0.0|3.83||||||||3.83|0.00|
74042984|NCT02980692|147637897|SUPERIORITY||Proportion with Adjustment of Background|2.56|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|0.0|6.07||||||||6.07|0.00|
73879971|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|0.42||||0.1349|TWO_SIDED|95.0|0.14|1.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.31|0.14|0.1349
73879972|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|0.57||||0.3191|TWO_SIDED|95.0|0.19|1.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.71|0.19|0.3191
73879973|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|0.3||||0.0623|TWO_SIDED|95.0|0.09|1.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.06|0.09|0.0623
73879974|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1958|TWO_SIDED|95.0|0.15|1.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.48|0.15|0.1958
74013517|NCT03882970|147577348|SUPERIORITY||LS Mean Difference|3.01|||<|0.001|TWO_SIDED|95.0|2.26|3.75|||ANCOVA|||Treatment Satisfaction Score||3.75|2.26|<0.001
74013518|NCT03882970|147577348|SUPERIORITY||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.15|3.65|||ANCOVA|||Treatment Satisfaction Score||3.65|2.15|<0.001
74042985|NCT02980692|147637897|SUPERIORITY||Proportion with Adjustment of Background|1.27|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|0.0|3.73||||||||3.73|0.00|
73879975|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|0.62||||0.4353|TWO_SIDED|95.0|0.19|2.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.05|0.19|0.4353
73879976|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9729|TWO_SIDED|95.0|0.31|3.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.31|0.31|0.9729
73879977|NCT03192176|147297617|SUPERIORITY||Odds Ratio (OR)|0.64||||0.4211|TWO_SIDED|95.0|0.22|1.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.89|0.22|0.4211
73879978|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.05||||0.1938|TWO_SIDED|95.0|0.57|16.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.35|0.57|0.1938
74013519|NCT03882970|147577348|SUPERIORITY||LS Mean Difference|2.99|||<|0.001|TWO_SIDED|95.0|2.24|3.74|||ANCOVA|||Treatment Satisfaction Score||3.74|2.24|<0.001
74042986|NCT02980692|147637898|SUPERIORITY||% response rate|85.07|STANDARD_ERROR_OF_MEAN|4.35|||TWO_SIDED|95.0|76.54|93.61||||||||93.61|76.54|
74013520|NCT03029143|147577373|OTHER||Odds Ratio (OR)|0.6|||=|0.401|TWO_SIDED|95.0|0.2|1.8|||Chi-squared||||Chi-squared test was used to estimate P-value from the logistic regression model where Endoscopic Mucosal Healing was the response variable and Treatment and TNF stratification were factors. Baseline complete Mayo Score and natural logarithm of trough concentration at week 6 were covariates.|1.8|0.2|=0.401
74042987|NCT02980692|147637898|SUPERIORITY||% response rate|81.25|STANDARD_ERROR_OF_MEAN|4.88|||TWO_SIDED|95.0|71.69|90.81||||||||90.81|71.69|
74042988|NCT02980692|147637898|SUPERIORITY||% response rate|76.27|STANDARD_ERROR_OF_MEAN|5.54|||TWO_SIDED|95.0|65.42|87.13||||||||87.13|65.42|
74042989|NCT02980692|147637898|SUPERIORITY||% response rate|71.05|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|60.86|81.25||||||||81.25|60.86|
74094502|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.244||||0.242|TWO_SIDED|95.0|-0.65|0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 4||0.17|-0.65|0.242
74042990|NCT02980692|147637898|SUPERIORITY||% response rate|65.33|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|54.56|76.1||||||||76.10|54.56|
74042991|NCT02980692|147637899|SUPERIORITY||% response rate|56.92|STANDARD_ERROR_OF_MEAN|6.14|||TWO_SIDED|95.0|44.88|68.96||||||||68.96|44.88|
74042992|NCT02980692|147637899|SUPERIORITY||% response rate|64.41|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|95.0|52.19|76.62||||||||76.62|52.19|
74042993|NCT02980692|147637899|SUPERIORITY||% response rate|45.0|STANDARD_ERROR_OF_MEAN|6.42|||TWO_SIDED|95.0|32.41|57.59||||||||57.59|32.41|
74042994|NCT02980692|147637899|SUPERIORITY||% response rate|47.06|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|35.2|58.92||||||||58.92|35.20|
74042995|NCT02980692|147637899|SUPERIORITY||% response rate|42.03|STANDARD_ERROR_OF_MEAN|5.94|||TWO_SIDED|95.0|30.38|53.68||||||||53.68|30.38|
74042996|NCT02980692|147637900|SUPERIORITY|||||||0.7081|||||||Cochran-Mantel-Haenszel|||||||0.7081
74042997|NCT02980692|147637900|SUPERIORITY|||||||0.9244|||||||Cochran-Mantel-Haenszel|||||||0.9244
74042998|NCT02980692|147637900|SUPERIORITY|||||||0.5365|||||||Cochran-Mantel-Haenszel|||||||0.5365
74042999|NCT02980692|147637900|SUPERIORITY|||||||0.2925|||||||Cochran-Mantel-Haenszel|||||||0.2925
74043000|NCT02980692|147637901|SUPERIORITY||Mean Difference (Net)|-14.453|STANDARD_DEVIATION|31.9358|||TWO_SIDED|||||||||||||
74043001|NCT02980692|147637901|SUPERIORITY||Mean Difference (Net)|-18.883|STANDARD_DEVIATION|57.1147|||TWO_SIDED|||||||||||||
74043002|NCT02980692|147637901|SUPERIORITY||Mean Difference (Net)|-27.084|STANDARD_DEVIATION|76.2272|||TWO_SIDED|||||||||||||
74094503|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.223||||0.278|TWO_SIDED|95.0|-0.63|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 5||0.18|-0.63|0.278
73879979|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|6.97||||0.0162|TWO_SIDED|95.0|1.43|33.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.91|1.43|0.0162
73879980|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|14.37||||0.0008|TWO_SIDED|95.0|3.04|67.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||67.96|3.04|0.0008
73879981|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|16.02||||0.0005|TWO_SIDED|95.0|3.39|75.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||75.68|3.39|0.0005
73879982|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.02||||0.1971|TWO_SIDED|95.0|0.56|16.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.17|0.56|0.1971
73879983|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0811|TWO_SIDED|95.0|0.83|22.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.27|0.83|0.0811
73879984|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|11.44||||0.0021|TWO_SIDED|95.0|2.43|53.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||53.94|2.43|0.0021
73879985|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.11||||0.137|TWO_SIDED|95.0|0.79|5.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.64|0.79|0.1370
74013521|NCT03029143|147577374|OTHER||Adjusted risk difference|-0.4|||=|0.943|TWO_SIDED|95.0|-11.4|10.6|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|10.6|-11.4|=0.943
74013522|NCT03029143|147577375|OTHER||Adjusted risk difference|-1.2|||=|0.893|TWO_SIDED|95.0|-18.7|16.3|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|16.3|-18.7|=0.893
73879986|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.2||||0.0181|TWO_SIDED|95.0|1.22|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.40|1.22|0.0181
73879987|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|6.43||||0.0002|TWO_SIDED|95.0|2.43|17.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.05|2.43|0.0002
73879988|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|6.08||||0.0003|TWO_SIDED|95.0|2.26|16.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.31|2.26|0.0003
73879989|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3241|TWO_SIDED|95.0|0.61|4.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.49|0.61|0.3241
73879990|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2249|TWO_SIDED|95.0|0.68|5.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.03|0.68|0.2249
73879991|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.53||||0.0096|TWO_SIDED|95.0|1.36|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.18|1.36|0.0096
74043003|NCT02980692|147637901|SUPERIORITY||Mean Difference (Net)|-26.173|STANDARD_DEVIATION|87.5367|||TWO_SIDED|||||||||||||
74043004|NCT02980692|147637901|SUPERIORITY||Mean Difference (Net)|-50.399|STANDARD_DEVIATION|141.677|||TWO_SIDED|||||||||||||
74013523|NCT03029143|147577376|OTHER||Adjusted risk difference|6.0|||=|0.525|TWO_SIDED|95.0|-12.4|24.3|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|24.3|-12.4|=0.525
74013524|NCT03029143|147577377|OTHER||Adjusted risk difference|-6.6|||=|0.623|TWO_SIDED|95.0|-34.0|20.8|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|20.8|-34.0|=0.623
74043005|NCT02980692|147637902|SUPERIORITY|||||||0.0203|||||||Cochran-Mantel-Haenszel|||||||0.0203
74043006|NCT02980692|147637902|SUPERIORITY|||||||0.5194|||||||Cochran-Mantel-Haenszel|||||||0.5194
74043007|NCT02980692|147637902|SUPERIORITY|||||||0.0599|||||||Cochran-Mantel-Haenszel|||||||0.0599
74043008|NCT02980692|147637902|SUPERIORITY|||||||0.122|||||||Cochran-Mantel-Haenszel|||||||0.1220
74043009|NCT02980692|147637903|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|1.86|||TWO_SIDED|||||||||||||
74043010|NCT02980692|147637903|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|1.56|||TWO_SIDED|||||||||||||
74043011|NCT02980692|147637903|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|2.08|||TWO_SIDED|||||||||||||
74013525|NCT03029143|147577378|SUPERIORITY||Adjusted risk difference|8.1|||=|0.344|TWO_SIDED|95.0|-8.5|24.7|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|24.7|-8.5|=0.344
74013526|NCT00619255|147577389|SUPERIORITY||Slope|1.38||||0.71|TWO_SIDED||||||Chi-squared|DF=3||||||0.71
74013527|NCT00619255|147577390|SUPERIORITY||Slope|1.02||||0.8|TWO_SIDED||||||Chi-squared|DF=3||||||0.80
74013528|NCT00619255|147577391|SUPERIORITY|||||||0.67|||||||Chi-squared|"DF = 1~Chi-Square Value = 0.18"||||||0.67
74013529|NCT00619255|147577392|SUPERIORITY||Slope|9.0||||0.03|TWO_SIDED||||||Chi-squared|DF=3||||||0.03
74013530|NCT00619255|147577393|SUPERIORITY||Slope|1.35||||0.72|TWO_SIDED||||||Chi-squared|DF=3||||||0.72
74013531|NCT02121262|147577407|SUPERIORITY||Rate Difference|1.5||||0.7431|TWO_SIDED|95.0|-5.9|8.9|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel (CMH) general association test stratified by baseline BCVA categories.||||8.9|-5.9|0.7431
74013532|NCT02121262|147577408|SUPERIORITY||Least Squares Mean (LSM) Difference|2.9|STANDARD_ERROR_OF_MEAN|0.89||0.0011|TWO_SIDED|95.0|1.17|4.66|||ANCOVA|The ANCOVA model included the treatment group as the main effect and baseline BCVA score as the covariate.|Null hypothesis-there was no difference in treatment groups of average BCVA CFB in 12-months. Hypothesis test-based on 2-sided test at 0.05 significance level,confidence interval(CI) was constructed between treatment groups in LSM using ANCOVA model.|||4.66|1.17|0.0011
74013533|NCT02121262|147577409|SUPERIORITY||Least Squares Mean Difference|-89.3|STANDARD_ERROR_OF_MEAN|16.89|<|0.0001|TWO_SIDED|95.0|-122.53|-56.01|||ANCOVA|Based on ANCOVA model with treatment and baseline BCVA categories as main effects and baseline retinal thickness as the covariate.|Null hypothesis was there was no difference in treatment groups in average BCVA CFB in 12-months. Hypothesis test was based on 2-sided test at 0.05 significance level. 2-sided 95% CI was constructed between treatment groups in LSM using ANCOVA model.|||-56.01|-122.53|<0.0001
74043012|NCT02980692|147637903|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|1.75|||TWO_SIDED|||||||||||||
74013534|NCT02121262|147577410|SUPERIORITY||Least Squares Mean Difference|-7.729|STANDARD_ERROR_OF_MEAN|1.0443|<|0.0001|TWO_SIDED|95.0|-9.7855|-5.6733|||ANCOVA|Based on ANCOVA model with treatment and baseline BCVA categories as main effects and baseline total leakage area as the covariate.|Null hypothesis was there was no difference in treatment groups in average BCVA CFB in 12-months. Hypothesis test was based on 2-sided test at 0.05 significance level. 2-sided 95% CI was constructed between treatment groups in LSM using ANCOVA model.|||-5.6733|-9.7855|<0.0001
74013535|NCT01765920|147577415|SUPERIORITY|||||||0.0174||||||A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.0174
74013536|NCT01765920|147577416|SUPERIORITY|||||||0.0719||||||A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.0719
74013537|NCT01765920|147577417|SUPERIORITY|||||||0.02||||||Total score analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.02
74013538|NCT01765920|147577417|SUPERIORITY|||||||0.0099||||||"Symptoms domain analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses)."|Kruskal-Wallis|||||||0.0099
74013539|NCT01765920|147577417|SUPERIORITY|||||||0.037||||||"Ability domain analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses)."|Kruskal-Wallis|||||||0.037
74013540|NCT01765920|147577418|SUPERIORITY|||||||0.22||||||Day 1 analysis.|Fisher Exact|||||||0.22
74013541|NCT01765920|147577418|SUPERIORITY|||||||0.32||||||Day 2 analysis.|Fisher Exact|||||||0.32
74013542|NCT01765920|147577418|SUPERIORITY|||||||0.47||||||Day 3 analysis.|Fisher Exact|||||||0.47
74013543|NCT01765920|147577418|SUPERIORITY|||||||0.72||||||Day 4 analysis.|Fisher Exact|||||||0.72
74013544|NCT01765920|147577418|SUPERIORITY|||||||0.25||||||Day 5 analysis.|Fisher Exact|||||||0.25
74013545|NCT01765920|147577419|SUPERIORITY|||||||0.68|||||||Fisher Exact|||||||0.68
74013546|NCT02411539|147577425|SUPERIORITY|Assuming that a common standard deviation of change (measured as difference of log10 transformed HIV-1 RNA/DNA ratios) in both arms was 0.30, with a sample size of 36 evaluable participants (18 in each arm), the study had 88% power to detect an effect size of 0.30 log10 (2-fold) in change of cell-associated HIV-1 RNA/DNA from baseline to week 6 using a two-sided Wilcoxon rank sum test at 10% type I error rate assuming a normal distribution||||||0.16||||||Two-sided Wilcoxon rank sum test at 10% significance level. Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The primary efficacy analysis compared the change in cell-associated HIV-1 RNA/DNA ratio (log-transformed) from baseline to week 6 between the two randomized arms, testing the null hypothesis of no difference in changes in cell-associated HIV-1 RNA/DNA ratio between the two arms using a Wilcoxon rank sum test at 10% significance level.||||0.16
74013547|NCT04041284|147577462|OTHER||LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.16|-1.21|||ANCOVA|||||-1.21|-3.16|<0.0001
74013548|NCT04041284|147577463|OTHER||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.61||0.0205|TWO_SIDED|95.0|-2.61|-0.22|||Mixed Models Analysis|||||-0.22|-2.61|0.0205
74043013|NCT02980692|147637903|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|1.82|||TWO_SIDED|||||||||||||
74043014|NCT01819506|147637912|SUPERIORITY|||||||0.912|||||||ANOVA|||||||0.912
73879992|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.35||||0.0768|TWO_SIDED|95.0|0.91|6.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.05|0.91|0.0768
73879993|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.91||||0.00251|TWO_SIDED|95.0|1.14|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.39|1.14|0.00251
73888017|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|126.9||||0.0006|TWO_SIDED|95.0|55.2|198.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||198.5|55.2|0.0006
74013549|NCT04041284|147577464|OTHER||Odds Ratio (OR)|3.26|||<|0.0001|TWO_SIDED|95.0|1.89|5.62|||Regression, Logistic|||||5.62|1.89|<0.0001
74013550|NCT04041284|147577465|OTHER||LS mean difference|11.3|STANDARD_ERROR_OF_MEAN|2.21|<|0.0001|TWO_SIDED|95.0|6.91|15.59|||Mixed Models Analysis||Restrictive score: Fremanezumab versus placebo|||15.59|6.91|<0.0001
74013551|NCT04041284|147577465|OTHER||LS mean difference|9.9|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED|95.0|5.73|14.08|||Mixed Models Analysis||Preventive score: Fremanezumab versus placebo|||14.08|5.73|<0.0001
74013552|NCT04041284|147577466|OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0915|TWO_SIDED|95.0|-0.39|0.03|||Mixed Models Analysis||Change at Week 4: Fremanezumab versus Placebo|||0.03|-0.39|0.0915
74013553|NCT04041284|147577466|OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11||0.0006|TWO_SIDED|95.0|-0.59|-0.16|||Mixed Models Analysis||Change at Week 8: Fremanezumab versus Placebo|||-0.16|-0.59|0.0006
74013554|NCT04041284|147577466|OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12||0.003|TWO_SIDED|95.0|-0.58|-0.12|||Mixed Models Analysis||Change at Week 12: Fremanezumab versus Placebo|||-0.12|-0.58|0.0030
74013555|NCT04041284|147577467|OTHER||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.15|-1.96|||Mixed Models Analysis|||||-1.96|-5.15|<0.0001
74013556|NCT01923129|147577487|NON_INFERIORITY|The primary outcome of interest was the rate of AUR, defined as the number of patients with AUR within each study group. A 15% non-inferiority margin was chosen according to clinical relevance estimation. The expected difference between the two groups was 0%. Non-inferiority analysis was performed by calculation of risk difference and its 95% confidence interval according to Newcombe \& Altman.|||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
74013557|NCT02909985|147577530|SUPERIORITY||F|23.68|||<|0.0001|TWO_SIDED||||||ANOVA|(9, 129)||||||<0.0001
74013558|NCT02909985|147577530|SUPERIORITY||F|9.4394|||<|0.0001|TWO_SIDED||||||ANOVA|(11, 52)||||||<0.0001
74013559|NCT03548935|147577551|SUPERIORITY||Treatment difference|-12.44|||<|0.0001|TWO_SIDED|95.0|-13.37|-11.51|||ANCOVA|||Treatment policy estimand||-11.51|-13.37|<.0001
74013560|NCT03548935|147577551|SUPERIORITY||Treatment difference|-14.42|||<|0.0001|TWO_SIDED|95.0|-15.29|-13.55|||ANCOVA|||Hypothetical estimand||-13.55|-15.29|<0.0001
74013561|NCT03548935|147577552|SUPERIORITY||Odds Ratio (OR)|11.22|||<|0.0001|TWO_SIDED|95.0|8.88|14.19|||Regression, Logistic|||Treatment policy estimand||14.19|8.88|<0.0001
74013562|NCT03548935|147577552|SUPERIORITY||Odds Ratio (OR)|37.03|||<|0.0001|TWO_SIDED|95.0|28.02|48.95|||Regression, Logistic|||Hypothetical estimand||48.95|28.02|<0.0001
74013563|NCT04677959|147577595|OTHER||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0||||||||The 95% credible intervals of the odds ratio from the posterior distributions were calculated and presented.||||
74013564|NCT00763815|147577614|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.731|-0.386||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms; randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 patients in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.386|-0.731|<0.0001
74013565|NCT01970995|147577624|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|13.49|||<|0.001|TWO_SIDED|95.0|10.96|16.6||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarker of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||16.60|10.96|<.001
74094504|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.282||||0.2|TWO_SIDED|95.0|-0.71|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 6||0.15|-0.71|0.200
74094505|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.456|TWO_SIDED|95.0|-0.6|0.27|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 7||0.27|-0.60|0.456
74094506|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.385||||0.076|TWO_SIDED|95.0|-0.81|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 8||0.04|-0.81|0.076
74094507|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.396||||0.084|TWO_SIDED|95.0|-0.85|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 9||0.05|-0.85|0.084
73879994|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0002|TWO_SIDED|95.0|2.3|15.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.57|2.30|0.0002
74094508|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.481||||0.04|TWO_SIDED|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 10||-0.02|-0.94|0.040
73879995|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|7.29|||<|0.0001|TWO_SIDED|95.0|2.7|19.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||19.71|2.70|<0.0001
74094509|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.405||||0.09|TWO_SIDED|95.0|-0.87|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 11||0.06|-0.87|0.090
74094510|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.432||||0.06|TWO_SIDED|95.0|-0.88|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 12||0.02|-0.88|0.060
74094511|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.277||||0.252|TWO_SIDED|95.0|-0.75|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 13||0.20|-0.75|0.252
74094512|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.229|TWO_SIDED|95.0|-0.79|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 14||0.19|-0.79|0.229
74094513|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.373||||0.109|TWO_SIDED|95.0|-0.83|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 15||0.08|-0.83|0.109
74094514|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.484|||||TWO_SIDED|95.0|-0.96|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 16||-0.01|-0.96|
74094515|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.003|TWO_SIDED|95.0|-1.17|-0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 17||-0.23|-1.17|0.003
73888018|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|53.2||||0.1449|TWO_SIDED|95.0|-18.5|124.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||124.8|-18.5|0.1449
74094516|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.326||||0.182|TWO_SIDED|95.0|-0.81|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 18||0.15|-0.81|0.182
74094517|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.299||||0.194|TWO_SIDED|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 19||0.15|-0.75|0.194
74094518|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.348||||0.129|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 20||0.10|-0.80|0.129
74094519|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.292||||0.232|TWO_SIDED|95.0|-0.77|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 21||0.19|-0.77|0.232
74094520|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.499||||0.042|TWO_SIDED|95.0|-0.98|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 22||-0.02|-0.98|0.042
74094521|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.356||||0.15|TWO_SIDED|95.0|-0.84|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 23||0.13|-0.84|0.150
74094522|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.398||||0.09|TWO_SIDED|95.0|-0.86|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 24||0.06|-0.86|0.090
74094523|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.028||||0.909|TWO_SIDED|95.0|-0.52|0.46|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 25||0.46|-0.52|0.909
74094524|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.233||||0.354|TWO_SIDED|95.0|-0.73|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 26||0.26|-0.73|0.354
74094525|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.245|TWO_SIDED|95.0|-0.78|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 27||0.20|-0.78|0.245
74094526|NCT00117325|147740170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.601||||0.038|TWO_SIDED|95.0|-1.17|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 28||-0.03|-1.17|0.038
74094527|NCT00759187|147740171|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two way Anova general linear model (subject and treatment as factors)|ANOVA|||||||<0.05
73879996|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.14||||0.1144|TWO_SIDED|95.0|0.83|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.50|0.83|0.1144
74013566|NCT01970995|147577625|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|50.67|||<|0.001|TWO_SIDED|95.0|44.88|57.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||57.20|44.88|<.001
74013567|NCT01970995|147577626|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|10.97|||<|0.001|TWO_SIDED|95.0|9.26|12.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||12.99|9.26|<.001
74013568|NCT01970995|147577627|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|44.94|||<|0.001|TWO_SIDED|95.0|42.11|47.97||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||47.97|42.11|<.001
74013569|NCT01970995|147577628|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.25|||<|0.001|TWO_SIDED|95.0|17.38|31.11||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||31.11|17.38|<.001
74013570|NCT05284760|147577634|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Geometric Mean Ratio (GMR)|97.28|||||TWO_SIDED|90.0|87.66|107.96||||||||107.96|87.66|
74013571|NCT05284760|147577634|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|81.04|||||TWO_SIDED|90.0|73.06|89.89||||||||89.89|73.06|
74013572|NCT05284760|147577634|OTHER||GMR|37.48|||||TWO_SIDED|90.0|31.1|45.17||||||||45.17|31.10|
74013573|NCT05284760|147577634|OTHER||GMR|89.45|||||TWO_SIDED|90.0|74.24|107.79||||||||107.79|74.24|
74043015|NCT00968708|147637919|NON_INFERIORITY_OR_EQUIVALENCE|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was \<1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was \<1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.962||||0.315|ONE_SIDED|97.5||1.16|||Cox proportional hazards|||Statistical analyses of the primary MACE composite endpoint was based on sequences of 1-sided repeated confidence intervals (CIs) to assess non-inferiority or statistical superiority with respect to the null hypotheses. Each sequence of repeated CIs was constructed using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%. Each sequence of 1-sided repeated CIs had a simultaneous coverage probability of 97.5%.||1.160||0.315
74043016|NCT00968708|147637919|NON_INFERIORITY_OR_EQUIVALENCE|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was \<1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was \<1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.965||||0.332|ONE_SIDED|97.5||1.169||Stratified by endpoint renal function (defined as the last observed postbaseline renal function (normal renal function/mild renal impairment vs moderate/severe renal impairment including end-stage renal disease)) and geographic region.|Cox proportional hazards|||Stratified by endpoint renal function and geographic region||1.169||0.332
74094528|NCT00296231|147740172|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||Paired Student's t-test was used to compare pre and post intervention pCO2 values.||||0.011
73879997|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1341|TWO_SIDED|95.0|0.8|5.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.30|0.80|0.1341
74013574|NCT05284760|147577635|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|97.52|||||TWO_SIDED|90.0|92.17|103.17||||||||103.17|92.17|
74013575|NCT05284760|147577635|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|86.88|||||TWO_SIDED|90.0|82.14|91.89||||||||91.89|82.14|
74013576|NCT05284760|147577635|OTHER||GMR|87.63|||||TWO_SIDED|90.0|75.92|101.15||||||||101.15|75.92|
74013577|NCT05284760|147577635|OTHER||GMR|95.49|||||TWO_SIDED|90.0|82.73|110.22||||||||110.22|82.73|
74013578|NCT05284760|147577636|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|99.25|||||TWO_SIDED|90.0|92.84|106.1||||||||106.10|92.84|
74013579|NCT05284760|147577636|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|86.98|||||TWO_SIDED|90.0|81.33|93.03||||||||93.03|81.33|
74013580|NCT05284760|147577636|OTHER||GMR|89.28|||||TWO_SIDED|90.0|78.92|100.99||||||||100.99|78.92|
74013581|NCT05284760|147577636|OTHER||GMR|92.77|||||TWO_SIDED|90.0|81.77|105.25||||||||105.25|81.77|
74013582|NCT04474795|147577691|SUPERIORITY||||||<|0.0001|||||||Wilcoxon paired signed rank test|||Compared pre and post training scores||||<0.0001
74094529|NCT01568320|147740264|SUPERIORITY_OR_OTHER_LEGACY||Freedom from Major adverse events (%)|71.6|||||TWO_SIDED|95.0|59.0|82.0|||||Clopper-Pearson (Exact) Method|||82|59|
74013583|NCT04474795|147577692|SUPERIORITY||||||<|0.0001|||||||Wilcoxon paired signed rank test|||Comparison of scores pre and post training in individuals who completed training modules||||<0.0001
74013584|NCT04474795|147577693|SUPERIORITY|||||||0.606|||||||Wilcoxon paired signed rank test|||Patient autonomy||||0.606
74013585|NCT04474795|147577693|SUPERIORITY|||||||0.003|||||||Wilcoxon paired signed rank test|||Value of tight control||||0.003
74013586|NCT04474795|147577693|SUPERIORITY|||||||0.475|||||||Wilcoxon paired signed rank test|||Need for Special Training||||0.475
74013587|NCT04474795|147577694|SUPERIORITY|||||||0.009|||||||Wilcoxon paired signed rank test|||||||0.009
74013588|NCT00563186|147577697|SUPERIORITY_OR_OTHER|This statistical analysis applies to the overall VRE, CDI and MRSA infection and colonization events expressed as incidence density (per 1000 patient-days at risk).|Incidence Rate ratio|1.6|STANDARD_ERROR_OF_MEAN|0.57||0.18|TWO_SIDED|95.0|0.8|3.22|||Poisson||Numerator is novel ward and denominator is traditional ward.|"It was calculated that this study will require 9750 patient days of observation in the traditional design wards and 19,500 patient days of observation in the novel design ward to ensure 80% statistical power to detect a 60% difference in the rates of incident cases of selected HAIs and ARO colonizations (the primary outcome measure) with an α level of 0.05 assuming that incident cases in each unit follow Poisson distribution based on well established historic trends on these units"||3.22|0.80|0.18
74013589|NCT00563186|147577699|SUPERIORITY_OR_OTHER||Rate Ratio|1.929|STANDARD_ERROR_OF_MEAN|0.493||0.175|TWO_SIDED|95.0|0.76|4.9|||Large test for person-time analysis|||||4.9|0.76|0.175
74013590|NCT03631732|147577703|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the upper bound of the 2-sided 95% confidence interval (CI) of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL is less than 6% (i.e., a margin of 6% is applied to non-inferiority assessment).|Difference in percentages|-1.2|||||TWO_SIDED|95.0|-4.8|0.9|||||Differences in percentages of participants with HIV-1 RNA \>= 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||0.9|-4.8|
74013591|NCT03631732|147577703|SUPERIORITY|||||||0.3399|||||||Fisher Exact|||||||0.3399
74013592|NCT03631732|147577705|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).|Difference in percentages|1.8|||||TWO_SIDED|95.0|-2.0|6.8|||||Differences in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||6.8|-2.0|
74013593|NCT03631732|147577705|SUPERIORITY|||||||0.3532|||||||Fisher Exact|||||||0.3532
74013594|NCT03631732|147577706|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).|Difference in percentages|1.4|||||TWO_SIDED|95.0|-1.0|5.3|||||Differences in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||5.3|-1.0|
74013595|NCT03631732|147577706|SUPERIORITY|||||||0.3356|||||||Fisher Exact|||||||0.3356
74013596|NCT03631732|147577708|OTHER||Difference in LSM|11.0||||0.5618|TWO_SIDED|95.0|-27.0|49.0|||ANOVA|P-value was calculated from ANOVA model with treatment as a fixed effect.|Difference in LSM (Least square mean) and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.|||49|-27|0.5618
74013597|NCT03631732|147577709|OTHER||Difference in LSM|9.0||||0.6632|TWO_SIDED|95.0|-31.0|48.0|||ANOVA|P-value was calculated from ANOVA model with treatment as a fixed effect.|Difference in LSM and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.|||48|-31|0.6632
74013598|NCT02873936|147577728|SUPERIORITY||Difference in Response Rates|34.9|||<|0.001|TWO_SIDED|95.0|23.5|46.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||46.3|23.5|<0.001
74013599|NCT02873936|147577728|SUPERIORITY||Difference in Response Rates|26.4|||<|0.001|TWO_SIDED|95.0|15.0|37.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||37.9|15.0|<0.001
74094530|NCT01568320|147740265|SUPERIORITY_OR_OTHER_LEGACY||Survival rate (%)|95.5|||||TWO_SIDED|95.0|87.0|99.0|||||Clopper-Pearson (Exact) Method|||99|87|
74013600|NCT02873936|147577729|SUPERIORITY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.066|<|0.001|TWO_SIDED|95.0|-0.45|-0.19||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. Least squares (LS)-Mean, 95% confidence interval (CI), and P-value were provided from mixed effects model for repeated measure (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-0.45|<0.001
74094531|NCT01394952|147740268|SUPERIORITY|"Superiority was declared if the upper limit of the 2-sided 95.33% confidence interval (CI) of the hazard ratio was below 1.0 (after adjustment for the interim analysis).~Once superiority was achieved for the primary endpoint, multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467."|Hazard Ratio (HR)|0.88||||0.026|TWO_SIDED|95.33|0.79|0.99|||Regression, Cox|||Primary CV endpoint||0.99|0.79|0.026
74094532|NCT01394952|147740269|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.91||||0.211|TWO_SIDED|95.0|0.78|1.06|||Regression, Cox|||Death from CV causes||1.06|0.78|0.211
74013601|NCT02873936|147577729|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.4|-0.14||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.14|-0.40|<0.001
74094533|NCT01394952|147740269|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.96||||0.652|TWO_SIDED|95.0|0.79|1.16|||Regression, Cox|||Nonfatal MI||1.16|0.79|0.652
74094534|NCT01394952|147740269|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.76||||0.017|TWO_SIDED|95.0|0.61|0.95|||Regression, Cox|||Nonfatal stroke||0.95|0.61|0.017
74094535|NCT01394952|147740270|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.9||||0.067|TWO_SIDED|95.0|0.8|1.01|||Regression, Cox|||Time to all cause mortality||1.01|0.80|0.067
74094536|NCT01394952|147740271|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.93|||Regression, Cox|||microvascular endpoint||0.93|0.79|<0.001
74094537|NCT01394952|147740272|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.93||||0.456|TWO_SIDED|95.0|0.77|1.12|||Regression, Cox|||Heart failure requiring hospitalization or an urgent heart failure clinic visit||1.12|0.77|0.456
74013602|NCT02873936|147577730|SUPERIORITY||Difference in Response Rates|25.3|||<|0.001|TWO_SIDED|95.0|14.7|35.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||35.8|14.7|<0.001
74013603|NCT02873936|147577730|SUPERIORITY||Difference in Response Rates|21.7|||<|0.001|TWO_SIDED|95.0|11.4|32.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||32.0|11.4|<0.001
74013604|NCT02873936|147577731|SUPERIORITY||Least Squares Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|2.5|6.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.1|2.5|<0.001
74013605|NCT02873936|147577731|SUPERIORITY||Least Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|1.6|5.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.2|1.6|<0.001
74094538|NCT01394952|147740273|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|1.14||||0.413|TWO_SIDED|95.0|0.84|1.54|||Regression, Cox|||Hospitalization for unstable angina||1.54|0.84|0.413
74094539|NCT01986010|147740281|OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|0.8|2.6||||||GMT Ratio: GMT V160/GMT placebo||2.6|0.8|
74094540|NCT01986010|147740281|OTHER||GMT Ratio|1.9|||||TWO_SIDED|95.0|1.1|3.2||||||GMT Ratio: GMT V160/GMT placebo||3.2|1.1|
74094541|NCT01986010|147740281|OTHER||GMT Ratio|3.5|||||TWO_SIDED|95.0|1.6|7.4||||||GMT Ratio: GMT V160/GMT placebo||7.4|1.6|
74094542|NCT01986010|147740281|OTHER||GMT Ratio|2.6|||||TWO_SIDED|95.0|1.4|4.6||||||GMT Ratio: GMT V160/GMT placebo||4.6|1.4|
74094543|NCT01986010|147740281|OTHER||GMT Ratio|1.6|||||TWO_SIDED|95.0|0.9|3.0||||||GMT Ratio: GMT V160/GMT placebo||3.0|0.9|
74094544|NCT01986010|147740281|OTHER||GMT Ratio|3.9|||||TWO_SIDED|95.0|2.2|7.0||||||GMT Ratio: GMT V160/GMT placebo||7.0|2.2|
74094545|NCT01986010|147740281|OTHER||GMT Ratio|16.4|||<|0.001|TWO_SIDED|95.0|9.5|28.4||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||28.4|9.5|<0.001
74094546|NCT01986010|147740281|OTHER||GMT Ratio|76.6|||<|0.001|TWO_SIDED|95.0|49.5|118.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||118.6|49.5|<0.001
74094547|NCT01986010|147740281|OTHER||GMT Ratio|68.1|||<|0.001|TWO_SIDED|95.0|40.1|115.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||115.6|40.1|<0.001
74043017|NCT00968708|147637920|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the confidence interval for the primary MACE composite was \<1.0, then statistical superiority of alogliptin to placebo for the secondary MACE composite would be demonstrated.|Hazard Ratio (HR)|0.952|||||ONE_SIDED|97.5||1.135||||||||1.135||
74043018|NCT01150760|147637938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0007|||||||Chi-squared|||||||0.0007
74043019|NCT01150760|147637939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9|||<|0.0001|||||||Chi-squared|||||||< 0.0001
74043020|NCT01150760|147637940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.0001|||||||Chi-squared|||||||0.0001
74043021|NCT01150760|147637941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.1022|||||||Chi-squared|||||||0.1022
74043022|NCT01150760|147637942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001|||||||Chi-squared|||||||< 0.0001
74094548|NCT01986010|147740281|OTHER||GMT Ratio|41.0|||<|0.001|TWO_SIDED|95.0|23.8|70.7||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||70.7|23.8|<0.001
74043023|NCT01150760|147637943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
74043024|NCT01150760|147637944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0012|||||||Chi-squared|||||||0.0012
74043025|NCT01150760|147637945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.003|||||||Chi-squared|||||||0.0030
74043026|NCT01150760|147637946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.7637|||||||Chi-squared|||||||0.7637
74043027|NCT01150760|147637947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.0402|||||||Chi-squared|||||||0.0402
74043028|NCT01150760|147637948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0755|||||||Chi-squared|||||||0.0755
74043029|NCT01150760|147637949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.0532|||||||Chi-squared|||||||0.0532
74043030|NCT01150760|147637950|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||< 0.0001
74043031|NCT01150760|147637951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
74043032|NCT03238352|147637956|OTHER||Difference of Least Square mean|-1.22|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.657|-0.782|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Negative Control at Week 8 is a primary endpoint comparison.||-0.782|-1.657|<0.0001
74043033|NCT03238352|147637956|OTHER||Difference of Least Square mean|-1.28|STANDARD_ERROR_OF_MEAN|0.213|<|0.0001|TWO_SIDED|95.0|-1.705|-0.858|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.858|-1.705|<.0001
74094549|NCT01986010|147740281|OTHER||GMT Ratio|128.6|||<|0.001|TWO_SIDED|95.0|87.0|190.3||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||190.3|87.0|<0.001
74043034|NCT03238352|147637956|OTHER||Difference of Least Square mean|-1.25|STANDARD_ERROR_OF_MEAN|0.176|<|0.0001|TWO_SIDED|95.0|-1.6|-0.901|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group was obtained by using estimates statement in the ANCOVA model.||-0.901|-1.600|<0.0001
74043035|NCT03238352|147637957|OTHER||Diference of Least Square mean|37.46|STANDARD_ERROR_OF_MEAN|7.306|<|0.0004|TWO_SIDED|95.0|22.916|51.995||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|||51.995|22.916|<0.0004
74094550|NCT01986010|147740281|OTHER||GMT Ratio|62.0|||<|0.001|TWO_SIDED|95.0|30.5|126.1||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||126.1|30.5|<0.001
74043036|NCT03238352|147637957|OTHER||Diference of Least Square mean|49.88|STANDARD_ERROR_OF_MEAN|7.079|<|0.0001|TWO_SIDED|95.0|35.791|63.966||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|||63.966|35.791|<.0001
74043037|NCT03238352|147637957|OTHER||Diference of Least Square mean|43.67|STANDARD_ERROR_OF_MEAN|5.862|<|0.0001|TWO_SIDED|95.0|32.001|55.334||P-value from Van Elteren test.|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group is obtained by using estimates statement in the ANCOVA model||55.334|32.001|<.0001
74043038|NCT04153929|147637976|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod linear model fit|Model assumption: The maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
74094551|NCT01986010|147740281|OTHER||GMT Ratio|63.0|||<|0.001|TWO_SIDED|95.0|31.9|124.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||124.6|31.9|<0.001
74094552|NCT02283983|147740321|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74094553|NCT03055650|147740322|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change from Baseline in Meibomian Gland Secretion Total Score at Week 1||||<0.0001
74094554|NCT03055650|147740322|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change from Baseline in Meibomian Gland Secretion Total Score at Month 1||||<0.0001
74094555|NCT03055650|147740323|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change From Baseline in Tear Break-Up Time (TBUT) at Week 1||||<0.0001
74094556|NCT03055650|147740323|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change From Baseline in Tear Break-Up Time (TBUT) at Month 1||||<0.0001
74094557|NCT03055650|147740324|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Week 1||||<0.0001
73879998|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|4.43||||0.0017|TWO_SIDED|95.0|1.75|11.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.22|1.75|0.0017
73879999|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1488|TWO_SIDED|95.0|0.77|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.50|0.77|0.1488
74094558|NCT03055650|147740324|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Month 1||||<0.0001
74094559|NCT03055650|147740325|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||||||<0.0001
74094560|NCT02912650|147740341|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|30.08|||<|0.001|TWO_SIDED|95.0|24.14|36.02|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.||36.02|24.14|<0.001
74094561|NCT02912650|147740341|SUPERIORITY_OR_OTHER||LS Mean Difference|5.66||||0.008|TWO_SIDED|95.0|1.51|9.8|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||9.80|1.51|0.008
74094562|NCT02912650|147740341|SUPERIORITY_OR_OTHER||LS Mean Difference|14.76|||<|0.001|TWO_SIDED|95.0|10.55|18.97|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||18.97|10.55|<0.001
74094563|NCT02912650|147740341|SUPERIORITY_OR_OTHER||LS Mean Difference|24.42|||<|0.001|TWO_SIDED|95.0|18.5|30.35|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||30.35|18.50|<0.001
74094564|NCT02912650|147740341|SUPERIORITY_OR_OTHER||LS Mean Difference|15.32|||<|0.001|TWO_SIDED|95.0|9.35|21.29|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||21.29|9.35|<0.001
74094565|NCT02912650|147740341|SUPERIORITY_OR_OTHER||LS Mean Difference|9.1|||<|0.001|TWO_SIDED|95.0|4.9|13.31|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||13.31|4.90|<0.001
74094566|NCT02912650|147740342|SUPERIORITY_OR_OTHER||LS Mean Difference|9.26|||<|0.001|TWO_SIDED|95.0|6.59|11.94|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||11.94|6.59|<0.001
74094567|NCT02912650|147740342|SUPERIORITY_OR_OTHER||LS Mean Difference|1.84||||0.053|TWO_SIDED|95.0|-0.03|3.71|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.71|-0.03|0.053
74094568|NCT02912650|147740342|SUPERIORITY_OR_OTHER||LS Mean Difference|5.59|||<|0.001|TWO_SIDED|95.0|3.69|7.49|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.49|3.69|<0.001
74094569|NCT02912650|147740342|SUPERIORITY_OR_OTHER||LS Mean Difference|7.42|||<|0.001|TWO_SIDED|95.0|4.75|10.09|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.09|4.75|<0.001
74094570|NCT02912650|147740342|SUPERIORITY_OR_OTHER||LS Mean Difference|3.67||||0.008|TWO_SIDED|95.0|0.98|6.36|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||6.36|0.98|0.008
74094571|NCT02912650|147740342|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75|||<|0.001|TWO_SIDED|95.0|1.85|5.64|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.64|1.85|<0.001
74094572|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|13.05|||<|0.001|TWO_SIDED|95.0|10.39|15.71|||ANOVA|||0-8 hours: Treatment difference and 95% CI were based on LS Mean from analysis of variance (ANOVA) with treatment, gender and baseline categorical PSR.||15.71|10.39|<0.001
74094573|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|3.01||||0.002|TWO_SIDED|95.0|1.15|4.86|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.86|1.15|0.002
74094574|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|6.94|||<|0.001|TWO_SIDED|95.0|5.06|8.83|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.83|5.06|<0.001
74094575|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|10.05|||<|0.001|TWO_SIDED|95.0|7.39|12.7|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.70|7.39|<0.001
74013606|NCT02873936|147577732|SUPERIORITY||Difference in Response Rates|18.5|||<|0.001|TWO_SIDED|95.0|8.6|28.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||28.3|8.6|<0.001
74013607|NCT02873936|147577732|SUPERIORITY||Difference in Response Rates|14.0||||0.003|TWO_SIDED|95.0|4.6|23.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||23.4|4.6|0.003
74013608|NCT02873936|147577733|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|2.6|7.3||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.3|2.6|<0.001
74013609|NCT02873936|147577733|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|1.18||0.007|TWO_SIDED|95.0|0.9|5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.5|0.9|0.007
74013610|NCT02873936|147577734|SUPERIORITY||Difference in Response Rates|15.0|||<|0.001|TWO_SIDED|95.0|6.4|23.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||23.7|6.4|<0.001
74013611|NCT02873936|147577734|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|5.7|22.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||22.6|5.7|<0.001
73880000|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0043|TWO_SIDED|95.0|1.54|10.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.30|1.54|0.0043
74013612|NCT02873936|147577734|SUPERIORITY||Difference in Response Rates|28.0|||<|0.001|TWO_SIDED|95.0|17.5|38.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||38.5|17.5|<0.001
74013613|NCT02873936|147577734|SUPERIORITY||Difference in Response Rates|17.2|||<|0.001|TWO_SIDED|95.0|7.1|27.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||27.2|7.1|<0.001
74013614|NCT02873936|147577734|SUPERIORITY||Difference in Response Rates|26.7|||<|0.001|TWO_SIDED|95.0|15.8|37.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||37.6|15.8|<0.001
74013615|NCT02873936|147577734|SUPERIORITY||Difference in Response Rates|16.4||||0.002|TWO_SIDED|95.0|5.9|26.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||26.9|5.9|0.002
74043039|NCT04153929|147637976|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Exponential model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
74043040|NCT04153929|147637976|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Emax 1 model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
74043041|NCT04153929|147637976|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Emax 2 model fit|Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
74094576|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|6.11|||<|0.001|TWO_SIDED|95.0|3.44|8.78|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.78|3.44|<0.001
74094577|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|3.94|||<|0.001|TWO_SIDED|95.0|2.06|5.81|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.81|2.06|<0.001
74013616|NCT02873936|147577735|SUPERIORITY||Difference in Response Rates|3.4||||0.16|TWO_SIDED|95.0|-1.9|8.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||8.8|-1.9|0.16
74013617|NCT02873936|147577735|SUPERIORITY||Difference in Response Rates|5.8||||0.039|TWO_SIDED|95.0|0.0|11.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||11.6|-0.0|0.039
74013618|NCT02873936|147577735|SUPERIORITY||Difference in Response Rates|15.0|||<|0.001|TWO_SIDED|95.0|6.5|23.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||23.5|6.5|<0.001
74013619|NCT02873936|147577735|SUPERIORITY||Difference in Response Rates|7.6||||0.036|TWO_SIDED|95.0|0.1|15.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||15.2|0.1|0.036
74013620|NCT02873936|147577735|SUPERIORITY||Difference in Response Rates|23.9|||<|0.001|TWO_SIDED|95.0|14.5|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||33.3|14.5|<0.001
74013621|NCT02873936|147577735|SUPERIORITY||Difference in Response Rates|12.2||||0.004|TWO_SIDED|95.0|3.7|20.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||20.6|3.7|0.004
74013622|NCT02873936|147577736|SUPERIORITY||Difference in Response Rates|26.0|||<|0.001|TWO_SIDED|95.0|14.6|37.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||37.4|14.6|<0.001
73880001|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|5.53||||0.0005|TWO_SIDED|95.0|2.1|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.57|2.10|0.0005
73880002|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|14.54|||<|0.0001|TWO_SIDED|95.0|4.85|43.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||43.58|4.85|<0.0001
73880003|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0262|TWO_SIDED|95.0|1.14|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.68|1.14|0.0262
73880004|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0009|TWO_SIDED|95.0|1.95|13.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.19|1.95|0.0009
73880005|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|5.33||||0.0006|TWO_SIDED|95.0|2.06|13.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.80|2.06|0.0006
73880006|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3673|TWO_SIDED|95.0|0.61|3.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||3.75|0.61|0.3673
73880007|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1207|TWO_SIDED|95.0|0.83|4.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.91|0.83|0.1207
73880008|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0011|TWO_SIDED|95.0|1.9|13.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.21|1.90|0.0011
73880009|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|9.19|||<|0.0001|TWO_SIDED|95.0|3.08|27.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||27.38|3.08|<0.0001
73880010|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0594|TWO_SIDED|95.0|0.97|5.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.86|0.97|0.0594
74094578|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|3.84|||<|0.001|TWO_SIDED|95.0|2.63|5.05|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.05|2.63|<0.001
73880011|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.47||||0.05|TWO_SIDED|95.0|1.0|6.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.09|1.00|0.0500
73880012|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0123|TWO_SIDED|95.0|1.29|8.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.03|1.29|0.0123
73880013|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2243|TWO_SIDED|95.0|0.71|4.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.37|0.71|0.2243
73880014|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0976|TWO_SIDED|95.0|0.87|5.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.24|0.87|0.0976
73880015|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0004|TWO_SIDED|95.0|2.25|16.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.44|2.25|0.0004
73880016|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|9.13|||<|0.0001|TWO_SIDED|95.0|3.04|27.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||27.40|3.04|<0.0001
74094579|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.013|TWO_SIDED|95.0|0.23|1.92|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.92|0.23|0.013
74094580|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|2.69|||<|0.001|TWO_SIDED|95.0|1.83|3.55|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.55|1.83|<0.001
74013623|NCT02873936|147577736|SUPERIORITY||Difference in Response Rates|18.8|||<|0.001|TWO_SIDED|95.0|7.5|30.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||30.0|7.5|<0.001
74013624|NCT02873936|147577736|SUPERIORITY||Difference in Response Rates|34.9|||<|0.001|TWO_SIDED|95.0|23.6|46.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||46.3|23.6|<0.001
74043042|NCT04153929|147637976|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
74043043|NCT04153929|147637976|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.76|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.46||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-0.46|-1.06|<0.0001
74043044|NCT04153929|147637976|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.01||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.01|-1.60|<0.0001
74043045|NCT04153929|147637976|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.56|||<|0.0001|TWO_SIDED|95.0|-1.87|-1.26||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.26|-1.87|<0.0001
74043046|NCT04153929|147637976|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.41|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.1||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.10|-1.72|<0.0001
74043047|NCT04153929|147637976|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.49|||<|0.0001|TWO_SIDED|95.0|-1.78|-1.19||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.19|-1.78|<0.0001
74043048|NCT04153929|147637976|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.84|-1.22||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.22|-1.84|<0.0001
74094581|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|1.56|3.98|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.98|1.56|<0.001
74094582|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15||||0.064|TWO_SIDED|95.0|-0.07|2.37|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.37|-0.07|0.064
74094583|NCT02912650|147740343|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62|||<|0.001|TWO_SIDED|95.0|0.76|2.47|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.47|0.76|<0.001
74013625|NCT02873936|147577736|SUPERIORITY||Difference in Response Rates|20.4|||<|0.001|TWO_SIDED|95.0|8.8|32.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||32.1|8.8|<0.001
74013626|NCT02873936|147577737|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.4||0.003|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.003
73880017|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1237|TWO_SIDED|95.0|0.82|5.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.17|0.82|0.1237
73880018|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0226|TWO_SIDED|95.0|1.16|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.41|1.16|0.0226
73880019|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0069|TWO_SIDED|95.0|1.42|8.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.91|1.42|0.0069
73880020|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.9||||0.1666|TWO_SIDED|95.0|0.76|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.75|0.76|0.1666
74013627|NCT02873936|147577737|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.027|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.027
74013628|NCT02873936|147577737|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
74013629|NCT02873936|147577737|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
74043049|NCT04153929|147637977|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod linear model fit|Model assumption: The maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
74043050|NCT04153929|147637977|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod exponential model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
74043051|NCT04153929|147637977|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Emax 1 model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
74094584|NCT02912650|147740344|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
74094585|NCT02912650|147740344|SUPERIORITY_OR_OTHER|||||||0.069|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.069
74094586|NCT02912650|147740344|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
74013630|NCT02873936|147577737|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-10.0|-4.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-10.0|<0.001
74043052|NCT04153929|147637977|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Emax 2 model fit|Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
74043053|NCT04153929|147637977|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
74043054|NCT04153929|147637977|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.11||||0.2228|TWO_SIDED|95.0|-2.9|0.68||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||0.68|-2.90|0.2228
74043055|NCT04153929|147637977|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.79|||<|0.0001|TWO_SIDED|95.0|-5.56|-2.01||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-2.01|-5.56|<0.0001
74043056|NCT04153929|147637977|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.61|||<|0.0001|TWO_SIDED|95.0|-7.41|-3.81||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.81|-7.41|<0.0001
74043057|NCT04153929|147637977|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-6.25|||<|0.0001|TWO_SIDED|95.0|-8.12|-4.38||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.38|-8.12|<0.0001
74043058|NCT04153929|147637977|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-6.25|||<|0.0001|TWO_SIDED|95.0|-8.02|-4.47||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.47|-8.02|<0.0001
74043059|NCT04153929|147637977|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-7.68|||<|0.0001|TWO_SIDED|95.0|-9.52|-5.83||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-5.83|-9.52|<0.0001
74094587|NCT02912650|147740344|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
74094588|NCT02912650|147740344|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
74094589|NCT02912650|147740344|SUPERIORITY_OR_OTHER|||||||0.005|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.005
74094590|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-45.27|||<|0.001|TWO_SIDED|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-31.58|-58.96|<0.001
74094591|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.88||||0.064|TWO_SIDED|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||0.50|-18.27|0.064
74094592|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.98|||<|0.001|TWO_SIDED|95.0|-36.91|-17.05|||ANOVA|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-17.05|-36.91|<0.001
74094593|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.26|||<|0.001|TWO_SIDED|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-22.07|-50.45|<0.001
74094594|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.58||||0.01|TWO_SIDED|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-4.52|-32.64|0.010
74094595|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.17|||<|0.001|TWO_SIDED|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-7.90|-28.44|<0.001
74094596|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-57.58|||<|0.001|TWO_SIDED|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-44.72|-70.44|<0.001
74094597|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.28||||0.004|TWO_SIDED|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-3.57|-18.99|0.004
74094598|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-28.06|||<|0.001|TWO_SIDED|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-19.35|-36.77|<0.001
74094599|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-46.01|||<|0.001|TWO_SIDED|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-32.04|-59.98|<0.001
74094600|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-29.7|||<|0.001|TWO_SIDED|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-15.75|-43.65|<0.001
74094601|NCT02912650|147740345|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.94|||<|0.001|TWO_SIDED|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-7.29|-26.59|<0.001
74094602|NCT02912650|147740346|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
74094603|NCT02912650|147740346|SUPERIORITY_OR_OTHER|||||||0.003|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.003
74094604|NCT02912650|147740346|SUPERIORITY_OR_OTHER|||||||0.031|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.031
74094605|NCT02912650|147740346|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
74094606|NCT02912650|147740346|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
74094607|NCT02912650|147740346|SUPERIORITY_OR_OTHER|||||||0.631|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.631
74094608|NCT02912650|147740347|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
74094609|NCT02912650|147740347|SUPERIORITY_OR_OTHER|||||||0.088|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.088
74094610|NCT02912650|147740347|SUPERIORITY_OR_OTHER|||||||0.133|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.133
74094611|NCT02912650|147740347|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
74094612|NCT02912650|147740347|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
74094613|NCT02912650|147740347|SUPERIORITY_OR_OTHER|||||||0.887|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.887
74094614|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.14|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|0.14|<0.001
74094615|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.034|TWO_SIDED|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|0.01|0.034
74094616|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.963|TWO_SIDED|95.0|-0.13|0.14|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.14|-0.13|0.963
74094617|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.062|TWO_SIDED|95.0|-0.01|0.37|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.37|-0.01|0.062
74094618|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.001|TWO_SIDED|95.0|0.13|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|0.13|0.001
74094619|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.04|TWO_SIDED|95.0|-0.28|-0.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||-0.01|-0.28|0.040
74094620|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|||<|0.001|TWO_SIDED|95.0|0.7|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.70|<0.001
74094621|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.095|TWO_SIDED|95.0|-0.03|0.37|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.37|-0.03|0.095
74094622|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.414|TWO_SIDED|95.0|-0.12|0.29|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.29|-0.12|0.414
74094623|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81|||<|0.001|TWO_SIDED|95.0|0.52|1.1|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.52|<0.001
74094624|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.61|1.19|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|0.61|<0.001
74094625|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.406|TWO_SIDED|95.0|-0.29|0.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.12|-0.29|0.406
74094626|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|1.4|2.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.09|1.40|<0.001
74094627|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.006|TWO_SIDED|95.0|0.1|0.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.58|0.10|0.006
73880021|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0317|TWO_SIDED|95.0|1.09|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|1.09|0.0317
73880022|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0011|TWO_SIDED|95.0|1.94|14.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.39|1.94|0.0011
73888019|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|38.7||||0.2882|TWO_SIDED|95.0|-33.0|110.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||110.4|-33.0|0.2882
74094628|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33||||0.009|TWO_SIDED|95.0|0.08|0.57|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.57|0.08|0.009
74094629|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41|||<|0.001|TWO_SIDED|95.0|1.07|1.75|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.75|1.07|<0.001
74094630|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|1.08|1.77|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.77|1.08|<0.001
74094631|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.908|TWO_SIDED|95.0|-0.26|0.23|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.23|-0.26|0.908
74094632|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.99|||<|0.001|TWO_SIDED|95.0|1.64|2.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.35|1.64|<0.001
74094633|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.002|TWO_SIDED|95.0|0.15|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|0.15|0.002
74094634|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|||<|0.001|TWO_SIDED|95.0|0.32|0.82|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.82|0.32|<0.001
74094635|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|1.25|1.95|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.95|1.25|<0.001
74094636|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|1.07|1.78|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.78|1.07|<0.001
74094637|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.157|TWO_SIDED|95.0|-0.07|0.43|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.07|0.157
74094638|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|||<|0.001|TWO_SIDED|95.0|1.73|2.48|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.48|1.73|<0.001
74094639|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.005|TWO_SIDED|95.0|0.11|0.63|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.63|0.11|0.005
74094640|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|||<|0.001|TWO_SIDED|95.0|0.52|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.52|<0.001
74094641|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|||<|0.001|TWO_SIDED|95.0|1.36|2.1|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.10|1.36|<0.001
74094642|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.31|||<|0.001|TWO_SIDED|95.0|0.94|1.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.94|<0.001
74094643|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.002|TWO_SIDED|95.0|0.15|0.68|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.68|0.15|0.002
74094644|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|2.06|||<|0.001|TWO_SIDED|95.0|1.67|2.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.45|1.67|<0.001
73880023|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|8.45||||0.0001|TWO_SIDED|95.0|2.81|25.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||25.46|2.81|0.0001
74013631|NCT02873936|147577737|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.5||0.006|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.006
74013632|NCT02873936|147577738|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.0||0.008|TWO_SIDED|95.0|-5.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-5.0|0.008
74013633|NCT02873936|147577738|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.0||0.65|TWO_SIDED|95.0|-2.0|1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-2.0|0.65
74013634|NCT02873936|147577738|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
74013635|NCT02873936|147577738|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.008|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|0.008
74013636|NCT02873936|147577738|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
74013637|NCT02873936|147577738|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.039|TWO_SIDED|95.0|-4.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-4.0|0.039
74013638|NCT02873936|147577739|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-17.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-17.0|<0.001
74013639|NCT02873936|147577739|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-16.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-16.0|<0.001
74013640|NCT02873936|147577739|SUPERIORITY||Least Squares Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-24.0|-12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-12.0|-24.0|<0.001
74013641|NCT02873936|147577739|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-19.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-19.0|<0.001
74013642|NCT02873936|147577739|SUPERIORITY||Least Squares Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-25.0|-12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-12.0|-25.0|<0.001
74013643|NCT02873936|147577739|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-19.0|-6.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-19.0|<0.001
74013644|NCT02873936|147577740|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-17.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-17.0|<0.001
74013645|NCT02873936|147577740|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-15.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-15.0|<0.001
74013646|NCT02873936|147577740|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-22.0|-11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-11.0|-22.0|<0.001
74013647|NCT02873936|147577740|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-18.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-18.0|<0.001
74013648|NCT02873936|147577740|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-18.0|-8.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-18.0|<0.001
74013649|NCT02873936|147577740|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.7||0.052|TWO_SIDED|95.0|-11.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-11.0|0.052
74013650|NCT02873936|147577741|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-21.0|-10.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-21.0|<0.001
74013651|NCT02873936|147577741|SUPERIORITY||Least Squares Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-19.0|-8.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-19.0|<0.001
74094645|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.004|TWO_SIDED|95.0|0.13|0.67|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|0.13|0.004
74094646|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.82|1.37|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.37|0.82|<0.001
74013652|NCT02873936|147577741|SUPERIORITY||Least Squares Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-23.0|-11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-11.0|-23.0|<0.001
74013653|NCT02873936|147577741|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-19.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-19.0|<0.001
74013654|NCT02873936|147577741|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-23.0|-10.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-23.0|<0.001
73880024|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1142|TWO_SIDED|95.0|0.84|5.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.27|0.84|0.1142
73880025|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.91||||0.025|TWO_SIDED|95.0|1.14|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.39|1.14|0.0250
73880026|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.08||||0.0166|TWO_SIDED|95.0|1.23|7.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.75|1.23|0.0166
73880027|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6033|TWO_SIDED|95.0|0.52|3.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.11|0.52|0.6033
73880028|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.05||||0.117|TWO_SIDED|95.0|0.84|5.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.02|0.84|0.1170
73880029|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.69||||0.04|TWO_SIDED|95.0|1.05|6.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.91|1.05|0.0400
73880030|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|5.61||||0.002|TWO_SIDED|95.0|1.88|16.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||16.72|1.88|0.0020
73880031|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5177|TWO_SIDED|95.0|0.54|3.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.37|0.54|0.5177
73880032|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.79||||0.2117|TWO_SIDED|95.0|0.72|4.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.48|0.72|0.2117
74043060|NCT04153929|147637978|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.66||||0.4439|TWO_SIDED|95.0|-2.34|1.03||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.03|-2.34|0.4439
73880033|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0426|TWO_SIDED|95.0|1.03|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.67|1.03|0.0426
73880034|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.54||||0.3508|TWO_SIDED|95.0|0.62|3.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.82|0.62|0.3508
74013655|NCT02873936|147577741|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-19.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-19.0|<0.001
74013656|NCT02873936|147577742|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.055|<|0.001|TWO_SIDED|95.0|-0.33|-0.11||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.33|<0.001
74013657|NCT02873936|147577742|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.055||0.006|TWO_SIDED|95.0|-0.26|-0.04||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.26|0.006
74013658|NCT02873936|147577742|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.075|<|0.001|TWO_SIDED|95.0|-0.51|-0.21||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.21|-0.51|<0.001
74094647|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|||<|0.001|TWO_SIDED|95.0|1.27|2.04|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.04|1.27|<0.001
74094648|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|||<|0.001|TWO_SIDED|95.0|0.58|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.36|0.58|<0.001
74094649|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.42|0.96|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.96|0.42|<0.001
74094650|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.001|TWO_SIDED|95.0|1.6|2.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.40|1.60|<0.001
74094651|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.002|TWO_SIDED|95.0|0.16|0.72|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.72|0.16|0.002
74013659|NCT02873936|147577742|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.075||0.003|TWO_SIDED|95.0|-0.37|-0.08||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.08|-0.37|0.003
74013660|NCT02873936|147577743|SUPERIORITY||Least Squares Mean Difference|-10.51|STANDARD_ERROR_OF_MEAN|1.578|<|0.001|TWO_SIDED|95.0|-13.61|-7.41||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.41|-13.61|<0.001
74094652|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.16|||<|0.001|TWO_SIDED|95.0|0.88|1.44|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.44|0.88|<0.001
74094653|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|1.16|1.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.96|1.16|<0.001
74094654|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84|||<|0.001|TWO_SIDED|95.0|0.44|1.24|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.24|0.44|<0.001
74094655|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.44|1.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.00|0.44|<0.001
74094656|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|||<|0.001|TWO_SIDED|95.0|1.5|2.31|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.31|1.50|<0.001
74094657|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.001|TWO_SIDED|95.0|0.18|0.74|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.74|0.18|0.001
74094658|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.14|||<|0.001|TWO_SIDED|95.0|0.85|1.43|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.85|<0.001
74094659|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|1.04|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.85|1.04|<0.001
74094660|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.77|||<|0.001|TWO_SIDED|95.0|0.36|1.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.17|0.36|<0.001
74094661|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.39|0.97|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.97|0.39|<0.001
74094662|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55|||<|0.001|TWO_SIDED|95.0|1.13|1.98|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.98|1.13|<0.001
74094663|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.017|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.017
74094664|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07|||<|0.001|TWO_SIDED|95.0|0.77|1.37|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.37|0.77|<0.001
74094665|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|||<|0.001|TWO_SIDED|95.0|0.78|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.62|0.78|<0.001
74094666|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.026|TWO_SIDED|95.0|0.06|0.91|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.91|0.06|0.026
74094667|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.42|1.01|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.01|0.42|<0.001
74094668|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.27|||<|0.001|TWO_SIDED|95.0|0.84|1.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.84|<0.001
74013661|NCT02873936|147577743|SUPERIORITY||Least Squares Mean Difference|-8.92|STANDARD_ERROR_OF_MEAN|1.577|<|0.001|TWO_SIDED|95.0|-12.02|-5.82||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.82|-12.02|<0.001
74013662|NCT02873936|147577743|SUPERIORITY||Least Squares Mean Difference|-10.94|STANDARD_ERROR_OF_MEAN|1.652|<|0.001|TWO_SIDED|95.0|-14.19|-7.69||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.69|-14.19|<0.001
74013663|NCT02873936|147577743|SUPERIORITY||Least Squares Mean Difference|-8.98|STANDARD_ERROR_OF_MEAN|1.651|<|0.001|TWO_SIDED|95.0|-12.22|-5.73||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.73|-12.22|<0.001
74013664|NCT02873936|147577743|SUPERIORITY||Least Squares Mean Difference|-9.87|STANDARD_ERROR_OF_MEAN|1.964|<|0.001|TWO_SIDED|95.0|-13.73|-6.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.00|-13.73|<0.001
74013665|NCT02873936|147577743|SUPERIORITY||Least Squares Mean Difference|-6.89|STANDARD_ERROR_OF_MEAN|1.987|<|0.001|TWO_SIDED|95.0|-10.8|-2.98||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.98|-10.80|<0.001
74013666|NCT02873936|147577744|SUPERIORITY||Difference in Response Rates|20.1|||<|0.001|TWO_SIDED|95.0|8.1|32.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||32.1|8.1|<0.001
74013667|NCT02873936|147577744|SUPERIORITY||Difference in Response Rates|14.5||||0.013|TWO_SIDED|95.0|2.4|26.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||26.5|2.4|0.013
74013668|NCT02873936|147577744|SUPERIORITY||Difference in Response Rates|22.2|||<|0.001|TWO_SIDED|95.0|10.3|34.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||34.1|10.3|<0.001
74043061|NCT04153929|147637978|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.28||||0.0001|TWO_SIDED|95.0|-4.95|-1.61||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.61|-4.95|0.0001
73880035|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4431|TWO_SIDED|95.0|0.58|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.45|0.58|0.4431
74013669|NCT02873936|147577744|SUPERIORITY||Difference in Response Rates|21.8|||<|0.001|TWO_SIDED|95.0|10.0|33.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||33.6|10.0|<0.001
74013670|NCT02873936|147577744|SUPERIORITY||Difference in Response Rates|33.3|||<|0.001|TWO_SIDED|95.0|21.8|44.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||44.9|21.8|<0.001
74013671|NCT02873936|147577744|SUPERIORITY||Difference in Response Rates|18.6||||0.001|TWO_SIDED|95.0|6.8|30.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||30.5|6.8|0.001
74013672|NCT02873936|147577745|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.1|-0.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-1.1|<0.001
74013673|NCT02873936|147577745|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.9|-0.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.9|<0.001
73888020|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|55.0||||0.1314|TWO_SIDED|95.0|-16.6|126.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||126.7|-16.6|0.1314
74013674|NCT02873936|147577745|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.5|-0.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.9|-1.5|<0.001
74013675|NCT02873936|147577745|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.3|-0.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.3|<0.001
74013676|NCT02873936|147577745|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.5|-0.8||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.5|<0.001
74013677|NCT02873936|147577745|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-1.1|<0.001
74013678|NCT02873936|147577746|SUPERIORITY||Difference in Response Rates|12.3||||0.004|TWO_SIDED|95.0|3.5|21.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||21.2|3.5|0.004
74013679|NCT02873936|147577746|SUPERIORITY||Difference in Response Rates|12.8||||0.003|TWO_SIDED|95.0|4.0|21.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||21.5|4.0|0.003
74013680|NCT02873936|147577746|SUPERIORITY||Difference in Response Rates|27.4|||<|0.001|TWO_SIDED|95.0|16.3|38.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||38.4|16.3|<0.001
74043062|NCT04153929|147637978|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-4.93|||<|0.0001|TWO_SIDED|95.0|-6.62|-3.23||P-value is considered nominal|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.23|-6.62|<0.0001
74094669|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.017|TWO_SIDED|95.0|0.07|0.66|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.07|0.017
74013681|NCT02873936|147577746|SUPERIORITY||Difference in Response Rates|17.0||||0.001|TWO_SIDED|95.0|6.2|27.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||27.7|6.2|0.001
74013682|NCT02873936|147577747|SUPERIORITY||Difference in Response Rates|7.5||||0.012|TWO_SIDED|95.0|1.3|13.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||13.7|1.3|0.012
74013683|NCT02873936|147577747|SUPERIORITY||Difference in Response Rates|9.1||||0.006|TWO_SIDED|95.0|2.7|15.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||15.5|2.7|0.006
74013684|NCT02873936|147577747|SUPERIORITY||Difference in Response Rates|14.3|||<|0.001|TWO_SIDED|95.0|5.6|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||23.1|5.6|<0.001
74013685|NCT02873936|147577747|SUPERIORITY||Difference in Response Rates|17.4|||<|0.001|TWO_SIDED|95.0|8.5|26.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||26.2|8.5|<0.001
74013686|NCT02873936|147577750|SUPERIORITY||Least Squares Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|-10.0|-4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.2|-10.0|<0.001
74094670|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.6|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.60|<0.001
74094671|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.48|1.33|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.33|0.48|<0.001
74094672|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.089|TWO_SIDED|95.0|-0.06|0.8|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.80|-0.06|0.089
74094673|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|||<|0.001|TWO_SIDED|95.0|0.24|0.83|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.83|0.24|<0.001
73880036|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|4.27||||0.005|TWO_SIDED|95.0|1.55|11.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||11.78|1.55|0.0050
73880037|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0023|TWO_SIDED|95.0|1.84|16.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||16.30|1.84|0.0023
74094674|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|||<|0.001|TWO_SIDED|95.0|0.6|1.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.44|0.60|<0.001
74094675|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.018|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.018
74094676|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.42|1.02|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.02|0.42|<0.001
74094677|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67||||0.002|TWO_SIDED|95.0|0.25|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.25|0.002
74094678|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.163|TWO_SIDED|95.0|-0.12|0.72|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.72|-0.12|0.163
74094679|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.016|TWO_SIDED|95.0|0.07|0.66|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.07|0.016
74094680|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68||||0.002|TWO_SIDED|95.0|0.26|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.26|0.002
74094681|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.496|TWO_SIDED|95.0|-0.19|0.4|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.19|0.496
74094682|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.003|TWO_SIDED|95.0|0.16|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.16|0.003
74094683|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.008|TWO_SIDED|95.0|0.15|1.0|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.00|0.15|0.008
74094684|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.315|TWO_SIDED|95.0|-0.21|0.64|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|-0.21|0.315
74094685|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.019|TWO_SIDED|95.0|0.06|0.66|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.06|0.019
74094686|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45||||0.038|TWO_SIDED|95.0|0.02|0.87|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.87|0.02|0.038
74094687|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.918|TWO_SIDED|95.0|-0.28|0.31|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.31|-0.28|0.918
74094688|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.105|TWO_SIDED|95.0|-0.05|0.55|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.55|-0.05|0.105
74094689|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.045|TWO_SIDED|95.0|0.01|0.85|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.85|0.01|0.045
74094690|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.355|TWO_SIDED|95.0|-0.22|0.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.22|0.355
74094691|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.127|TWO_SIDED|95.0|-0.07|0.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.07|0.127
74094692|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.171|TWO_SIDED|95.0|-0.12|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.70|-0.12|0.171
74094693|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.79|TWO_SIDED|95.0|-0.25|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.33|-0.25|0.790
74094694|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.235|TWO_SIDED|95.0|-0.12|0.47|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.47|-0.12|0.235
74094695|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.236|TWO_SIDED|95.0|-0.16|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|-0.16|0.236
74094696|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.599|TWO_SIDED|95.0|-0.3|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.30|0.599
74094697|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.353|TWO_SIDED|95.0|-0.15|0.43|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.15|0.353
74013687|NCT02873936|147577750|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.46|<|0.001|TWO_SIDED|95.0|-7.9|-2.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-7.9|<0.001
74013688|NCT02873936|147577750|SUPERIORITY||Least Squares Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-12.6|-6.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.5|-12.6|<0.001
74013689|NCT02873936|147577750|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-10.6|-4.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-10.6|<0.001
74013690|NCT02873936|147577750|SUPERIORITY||Least Squares Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|-11.9|-5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.5|-11.9|<0.001
73880038|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5663|TWO_SIDED|95.0|0.52|3.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.32|0.52|0.5663
74013691|NCT02873936|147577750|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|1.66||0.003|TWO_SIDED|95.0|-8.2|-1.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-8.2|0.003
74013692|NCT02873936|147577751|SUPERIORITY||Least Squares Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-11.1|-5.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.1|-11.1|<0.001
74013693|NCT02873936|147577751|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-8.9|-2.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-8.9|<0.001
74013694|NCT02873936|147577751|SUPERIORITY||Least Squares Mean Difference|-10.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-13.8|-7.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.5|-13.8|<0.001
74013695|NCT02873936|147577751|SUPERIORITY||Least Squares Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|-11.8|-5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.5|-11.8|<0.001
74013696|NCT02873936|147577751|SUPERIORITY||Least Squares Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-13.5|-6.8||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.8|-13.5|<0.001
74013697|NCT02873936|147577751|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-9.4|-2.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.7|-9.4|<0.001
74043063|NCT04153929|147637978|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.76|||<|0.0001|TWO_SIDED|95.0|-7.53|-4.0||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.00|-7.53|<0.0001
74013698|NCT02873936|147577753|SUPERIORITY||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.1|3.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.1|<0.001
74013699|NCT02873936|147577753|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.7||0.005|TWO_SIDED|95.0|0.6|3.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|0.6|0.005
74013700|NCT02873936|147577753|SUPERIORITY||Least Squares Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|1.9|5.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.9|1.9|<0.001
74013701|NCT02873936|147577753|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.03||0.002|TWO_SIDED|95.0|1.1|5.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.2|1.1|0.002
74013702|NCT02873936|147577755|SUPERIORITY||Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|0.97||0.019|TWO_SIDED|95.0|0.4|4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.2|0.4|0.019
74013703|NCT02873936|147577755|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.97||0.073|TWO_SIDED|95.0|-0.2|3.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.6|-0.2|0.073
74043064|NCT04153929|147637978|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.44|||<|0.0001|TWO_SIDED|95.0|-7.11|-3.77||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.77|-7.11|<0.0001
74013704|NCT02873936|147577755|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.03||0.045|TWO_SIDED|95.0|0.0|4.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|0.0|0.045
74013705|NCT02873936|147577755|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.02||0.32|TWO_SIDED|95.0|-1.0|3.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-1.0|0.32
74013706|NCT02873936|147577755|SUPERIORITY||Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|1.19||0.12|TWO_SIDED|95.0|-0.5|4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.2|-0.5|0.12
74013707|NCT02873936|147577755|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.2||0.96|TWO_SIDED|95.0|-2.3|2.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.4|-2.3|0.96
74043065|NCT04153929|147637978|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-7.05|||<|0.0001|TWO_SIDED|95.0|-8.79|-5.31||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-5.31|-8.79|<0.0001
74094698|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.293|TWO_SIDED|95.0|-0.19|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.19|0.293
74013708|NCT02873936|147577757|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.6|5.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.7|1.6|<0.001
74013709|NCT02873936|147577757|SUPERIORITY||Least Squares Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|1.05||0.002|TWO_SIDED|95.0|1.2|5.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.4|1.2|0.002
74013710|NCT02873936|147577757|SUPERIORITY||Least Squares Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.28|<|0.001|TWO_SIDED|95.0|2.1|7.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.1|2.1|<0.001
74013711|NCT02873936|147577757|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.3||0.11|TWO_SIDED|95.0|-0.5|4.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.7|-0.5|0.11
74013712|NCT02873936|147577760|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|2.5||0.009|TWO_SIDED|95.0|2.0|11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||11.0|2.0|0.009
74013713|NCT02873936|147577760|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|2.5||0.003|TWO_SIDED|95.0|3.0|12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|3.0|0.003
74013714|NCT02873936|147577760|SUPERIORITY||Least Squares Mean Difference|8.0|STANDARD_ERROR_OF_MEAN|2.6||0.003|TWO_SIDED|95.0|3.0|13.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||13.0|3.0|0.003
74013715|NCT02873936|147577760|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|2.6||0.006|TWO_SIDED|95.0|2.0|12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|2.0|0.006
74013716|NCT02873936|147577760|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|2.9||0.002|TWO_SIDED|95.0|3.0|15.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||15.0|3.0|0.002
74013717|NCT02873936|147577760|SUPERIORITY||Least Squares Mean Difference|8.0|STANDARD_ERROR_OF_MEAN|2.9||0.007|TWO_SIDED|95.0|2.0|14.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||14.0|2.0|0.007
74013718|NCT02943564|147577769|SUPERIORITY||Least Squares Mean Difference|0.1||||0.8862|TWO_SIDED|95.0|-1.5|1.73|||Mixed Model Repeated Measures (MMRM)|||||1.73|-1.50|0.8862
74013719|NCT02943564|147577769|SUPERIORITY||Least Squares Mean Difference|-0.5||||0.5772|TWO_SIDED|95.0|-2.07|1.16|||Mixed Model Repeated Measures (MMRM)|||||1.16|-2.07|0.5772
74013720|NCT02943564|147577770|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.8967|TWO_SIDED|95.0|-1.48|1.29|||Mixed Model Repeated Measures (MMRM)|||||1.29|-1.48|0.8967
74013721|NCT02943564|147577770|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9963|TWO_SIDED|95.0|-1.38|1.39|||Mixed Model Repeated Measures (MMRM)|||||1.39|-1.38|0.9963
74043066|NCT04153929|147637978|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.85|||<|0.0001|TWO_SIDED|95.0|-5.52|-2.18||P-value is considered nominal.|Mixed Model Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as Semaglutide - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-2.18|-5.52|<0.0001
74094699|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.986|TWO_SIDED|95.0|-0.28|0.28|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.28|0.986
73880039|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0461|TWO_SIDED|95.0|1.02|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.83|1.02|0.0461
73880040|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0552|TWO_SIDED|95.0|0.98|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.38|0.98|0.0552
73880041|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.95||||0.1536|TWO_SIDED|95.0|0.78|4.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.88|0.78|0.1536
74013722|NCT01225731|147577778|SUPERIORITY_OR_OTHER||% Difference in Response Rate|28.89||||0.001|TWO_SIDED|95.0|13.41|44.36|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||44.36|13.41|0.001
74013723|NCT01225731|147577778|SUPERIORITY_OR_OTHER||% Difference in Response Rate|60.0|||<|0.001|TWO_SIDED|95.0|48.42|71.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||71.58|48.42|<0.001
74013724|NCT01225731|147577778|SUPERIORITY_OR_OTHER||% Difference in Response Rate|61.85|||<|0.001|TWO_SIDED|95.0|50.33|73.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||73.37|50.33|<0.001
74013725|NCT01225731|147577778|SUPERIORITY_OR_OTHER||% Difference in Response Rate|69.97|||<|0.001|TWO_SIDED|95.0|58.96|80.99|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||80.99|58.96|<0.001
74013726|NCT01225731|147577779|SUPERIORITY_OR_OTHER||% Difference in Response Rate|19.37||||0.009|TWO_SIDED|95.0|5.15|33.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||33.58|5.15|0.009
74013727|NCT01225731|147577779|SUPERIORITY_OR_OTHER||% Difference in Response Rate|54.44|||<|0.001|TWO_SIDED|95.0|42.63|66.26|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||66.26|42.63|<0.001
74013728|NCT01225731|147577779|SUPERIORITY_OR_OTHER||% Difference in Response Rate|56.23|||<|0.001|TWO_SIDED|95.0|44.43|68.03|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||68.03|44.43|<0.001
74013729|NCT01225731|147577779|SUPERIORITY_OR_OTHER||% Difference in Response Rate|67.65|||<|0.001|TWO_SIDED|95.0|56.42|78.88|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||78.88|56.42|<0.001
74013730|NCT01225731|147577780|SUPERIORITY_OR_OTHER||% Difference in Response Rate|31.11|||<|0.001|TWO_SIDED|95.0|16.22|46.0|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||46.0|16.22|<0.001
74013731|NCT01225731|147577780|SUPERIORITY_OR_OTHER||% Difference in Response Rate|55.56|||<|0.001|TWO_SIDED|95.0|44.48|66.63|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||66.63|44.48|<0.001
74013732|NCT01225731|147577780|SUPERIORITY_OR_OTHER||% Difference in Response Rate|59.58|||<|0.001|TWO_SIDED|95.0|48.6|70.55|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||70.55|48.60|<0.001
74013733|NCT01225731|147577780|SUPERIORITY_OR_OTHER||% Difference in Response Rate|72.2|||<|0.001|TWO_SIDED|95.0|62.02|82.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||82.37|62.02|<0.001
74013734|NCT00577642|147577791|OTHER|single group|||||<|0.05|||||||t-test, 1 sided|||Paired t-tests were used to compare differences of NTX cytokine levels at study entry versus end-of-study.||||<0.05
74043067|NCT04153929|147637979|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.62||||0.7708|TWO_SIDED|95.0|-4.82|3.57||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||3.57|-4.82|0.7708
73880042|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.69||||0.2575|TWO_SIDED|95.0|0.68|4.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.20|0.68|0.2575
73880043|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0096|TWO_SIDED|95.0|1.38|10.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.11|1.38|0.0096
73880044|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|8.48||||0.0003|TWO_SIDED|95.0|2.69|26.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||26.76|2.69|0.0003
74013735|NCT04341441|147577792|SUPERIORITY|Sample size was determined with one planned interim analysis when 50% of participants had completed their 8 weeks of treatment using an O'Brien-Fleming alpha spending method to ensure an overall type 1 error of 0.05. With a sample size of 900 per group and alpha = 0.0492, the power to detect a 32% reduction in COVID-19 disease rate (10% vs 6.8%) between the placebo and HCQ treated groups, determined at 87%. Study required 1000 per group with a total of 3000 patients to complete the trial.|Risk Ratio (RR)|0.32||||0.75|TWO_SIDED|||||P-value for the comparison between groups, including the non-randomized active comparator, was 0.75.|Mantel Haenszel||Low number of primary events precluded estimated value of risk ratio.|||||0.75
74013736|NCT01556425|147577808|SUPERIORITY||Odds Ratio (OR)|2.26||||0.48|TWO_SIDED|95.0|0.2|21.6|||General Estimating Equation (GEE)|||||21.6|0.2|0.48
73880045|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1047|TWO_SIDED|95.0|1.48|10.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.35|1.48|0.1047
73880046|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.91||||0.006|TWO_SIDED|95.0|1.48|10.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.35|1.48|0.0060
73880047|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0414|TWO_SIDED|95.0|1.04|6.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.71|1.04|0.0414
73880048|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0809|TWO_SIDED|95.0|0.9|5.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.89|0.90|0.0809
73880049|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2377|TWO_SIDED|95.0|0.69|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.34|0.69|0.2377
73880050|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0087|TWO_SIDED|95.0|1.44|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.34|1.44|0.0087
73880051|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0022|TWO_SIDED|95.0|1.9|18.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||18.94|1.90|0.0022
74013737|NCT01556425|147577808|SUPERIORITY||Odds Ratio (OR)|0.58||||0.61|TWO_SIDED|95.0|0.1|4.6|||General Estimating Equation (GEE)|||||4.6|0.1|0.61
74013738|NCT01556425|147577808|SUPERIORITY||Odds Ratio (OR)|6.0||||0.11|TWO_SIDED|95.0|0.7|54.9|||General Estimating Equation (GEE)|||||54.9|0.7|0.11
74043068|NCT04153929|147637979|OTHER|No formal hypotheses were tested.|Difference of adjusted means|0.68||||0.7462|TWO_SIDED|95.0|-3.44|4.79||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||4.79|-3.44|0.7462
73880052|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.4||||0.4788|TWO_SIDED|95.0|0.55|3.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.55|0.55|0.4788
73880053|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.98||||0.0074|TWO_SIDED|95.0|1.45|10.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.94|1.45|0.0074
73880054|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0187|TWO_SIDED|95.0|1.22|8.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.75|1.22|0.0187
73880055|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3443|TWO_SIDED|95.0|0.62|4.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.00|0.62|0.3443
74013739|NCT01556425|147577808|SUPERIORITY||Odds Ratio (OR)|2.66||||0.39|TWO_SIDED|95.0|0.3|24.9|||General Estimating Equation (GEE)|||||24.9|0.3|0.39
74013740|NCT01556425|147577808|SUPERIORITY||Odds Ratio (OR)|10.4||||0.03|TWO_SIDED|95.0|1.3|85.5|||General Estimating Equation (GEE)|||||85.5|1.3|0.03
74013741|NCT01556425|147577809|SUPERIORITY||Odds Ratio (OR)|0.36||||0.3|TWO_SIDED|95.0|0.1|2.4|||General Estimating Equation (GEE)|||||2.4|0.1|0.30
74013742|NCT01556425|147577809|SUPERIORITY||Odds Ratio (OR)|0.2||||0.08|TWO_SIDED|95.0|0.03|1.2|||General Estimating Equation (GEE)|||||1.2|0.03|0.08
73880056|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.66||||0.2867|TWO_SIDED|95.0|0.65|4.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.22|0.65|0.2867
74013743|NCT01556425|147577809|SUPERIORITY||Odds Ratio (OR)|0.91||||0.91|TWO_SIDED|95.0|0.1|5.8|||General Estimating Equation (GEE)|||||5.8|0.1|0.91
74013744|NCT01556425|147577809|SUPERIORITY||Odds Ratio (OR)|2.47||||0.34|TWO_SIDED|95.0|0.4|15.8|||General Estimating Equation (GEE)|||||15.8|0.4|0.34
74013745|NCT01556425|147577809|SUPERIORITY||Odds Ratio (OR)|4.46||||0.09|TWO_SIDED|95.0|0.8|26.1|||General Estimating Equation (GEE)|||||26.1|0.8|0.09
74094700|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.459|TWO_SIDED|95.0|-0.18|0.39|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.39|-0.18|0.459
74094701|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.287|TWO_SIDED|95.0|-0.18|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.18|0.287
74013746|NCT01505634|147577810|NON_INFERIORITY|Non-inferiority for the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-3.1||||0.005|TWO_SIDED|95.0|-11.2|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Difference (Diff) in Favorable MR||3.2|-11.2|0.005
74013747|NCT01505634|147577810|NON_INFERIORITY|Non-inferiority for the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-6.4|5.9|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Favorable MR||5.9|-6.4|< 0.001
74013748|NCT01505634|147577811|OTHER|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|TWO_SIDED|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with Event of Clinical Interest (ECI) #1||5.5|-2.7|0.315
74013749|NCT01505634|147577811|OTHER|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|TWO_SIDED|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #1||5.5|-2.7|0.315
74013750|NCT01505634|147577812|OTHER|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP \<2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff Participants with ECI #2||3.8|-3.7|> 0.999
74013751|NCT01505634|147577812|OTHER|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP \<2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #2||3.8|-3.7|> 0.999
74013752|NCT01505634|147577813|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.7||||||95.0|-14.3|10.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs||10.9|-14.3|
74013753|NCT01505634|147577813|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-0.7|||||TWO_SIDED|95.0|-13.4|12.0|||||Relebactam minus Placebo|Percent Diff in Participants with AEs||12.0|-13.4|
74013754|NCT01505634|147577814|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-5.8|5.9|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs||5.9|-5.8|
74013755|NCT01505634|147577814|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-7.6|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs||2.8|-7.6|
74013756|NCT01505634|147577815|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||TWO_SIDED|95.0|-7.5|9.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs||9.8|-7.5|
74013757|NCT01505634|147577815|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.1|||||TWO_SIDED|95.0|-8.4|8.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs||8.6|-8.4|
74013758|NCT01505634|147577816|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs||4.6|-4.5|
74013759|NCT01505634|147577816|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-5.5|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs||2.8|-5.5|
74013760|NCT01505634|147577817|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||TWO_SIDED|95.0|-4.4|6.8|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs||6.8|-4.4|
74013761|NCT01505634|147577817|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-6.1|3.7|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs||3.7|-6.1|
74013762|NCT01505634|147577818|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||TWO_SIDED|95.0|-3.6|6.2|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs||6.2|-3.6|
74013763|NCT01505634|147577818|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs||4.6|-4.5|
74013764|NCT01505634|147577819|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||TWO_SIDED|95.0|-5.5|7.8|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea||7.8|-5.5|
74013765|NCT01505634|147577819|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea||3.6|-8.1|
74013766|NCT01505634|147577819|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-6.4|6.5|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea||6.5|-6.4|
74013767|NCT01505634|147577819|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|2.1|||||TWO_SIDED|95.0|-4.6|9.2|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea||9.2|-4.6|
73880057|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|5.12||||0.0044|TWO_SIDED|95.0|1.66|15.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||15.78|1.66|0.0044
74013768|NCT01505634|147577819|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria||1.9|-9.0|
74013769|NCT01505634|147577819|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria||3.6|-8.1|
74013770|NCT01505634|147577819|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive||1.9|-9.0|
74013771|NCT01505634|147577819|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive||1.9|-9.0|
74013772|NCT01505634|147577819|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|3.1|||||TWO_SIDED|95.0|-3.7|10.4|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache||10.4|-3.7|
74013773|NCT01505634|147577819|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-7.2|5.1|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache||5.1|-7.2|
74013774|NCT02054897|147577826|SUPERIORITY|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% confidence interval (CI) for the estimated difference was below 0%.|Treatment difference|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.81|-1.25|||Mixed Models Analysis||Semaglutide 1.0 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 1.0 mg versus placebo. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-1.25|-1.81|< 0.0001
74043069|NCT04153929|147637979|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.32||||0.1302|TWO_SIDED|95.0|-7.62|0.98||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||0.98|-7.62|0.1302
74043070|NCT04153929|147637979|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-4.61||||0.0414|TWO_SIDED|95.0|-9.03|-0.18||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-0.18|-9.03|0.0414
74013775|NCT02054897|147577826|SUPERIORITY|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Treatment difference|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.71|-1.15|||Mixed Models Analysis||Semaglutide 0.5 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 0.5 mg versus placebo, if superiority for semaglutide 1.0 mg was concluded. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-1.15|-1.71|< 0.0001
74013776|NCT01692275|147577837|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.4|-0.7||||||All sites combined (week 6) - Between-group differences of mean in LBP||-0.7|-1.4|
74043071|NCT04153929|147637979|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-2.55||||0.2273|TWO_SIDED|95.0|-6.71|1.6||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.60|-6.71|0.2273
74013777|NCT01692275|147577837|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.2|-0.5||||||All sites combined (week 12) - Between-group differences of mean in LBP||-0.5|-1.2|
74013778|NCT01692275|147577837|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.3|-0.1||||||Walter Reed site (week 6) - Between-group differences of mean in LBP||-0.1|-1.3|
74013779|NCT01692275|147577837|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||Walter Reed site (week 12) - Between-group differences of mean in LBP||0.2|-1.0|
74013780|NCT01692275|147577837|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.8|-0.6||||||Naval Hospital Pensacola site (week 6) - Between-group differences of mean in LBP||-0.6|-1.8|
74013781|NCT01692275|147577837|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.8|-0.5||||||Naval Hospital Pensacola site (week 12) - Between-group differences of mean in LBP||-0.5|-1.8|
74013782|NCT01692275|147577837|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-1.9|-0.8||||||Naval Medical Center San Diego site (week 6) - Between-group differences of mean in LBP||-0.8|-1.9|
74013783|NCT01692275|147577837|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.7|-0.5||||||Naval Medical Center San Diego (week 12) - Between-group differences of mean in LBP||-0.5|-1.7|
74043072|NCT04153929|147637979|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-8.4||||0.0002|TWO_SIDED|95.0|-12.81|-3.98||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.98|-12.81|0.0002
74043073|NCT04153929|147637979|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-2.72||||0.1967|TWO_SIDED|95.0|-6.86|1.42||P-value is considered nominal.|Mixed Model Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as Semaglutide - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.42|-6.86|0.1967
74043074|NCT04153929|147637980|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.28|5.2|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||5.20|0.28|
74043075|NCT04153929|147637980|OTHER||Odds Ratio (OR)|7.92|||||TWO_SIDED|95.0|2.43|25.74|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||25.74|2.43|
74013784|NCT01692275|147577838|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-3.1|-1.2||||||All sites combined (week 6) - RMDQ Between-Group Differences in Disability||-1.2|-3.1|
74013785|NCT01692275|147577838|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|95.0|-3.0|-1.0||||||All sites combined (week 12) - RMDQ Between-Group Differences in Disability||-1.0|-3.0|
74013786|NCT01692275|147577838|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-3.4|-0.2||||||Walter Reed site (week 6) - RMDQ Between-Group Differences in Disability||-0.2|-3.4|
74013787|NCT01692275|147577838|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.2|0.2||||||Walter Reed site (week 12) - RMDQ Between-Group Differences in Disability||0.2|-3.2|
74013788|NCT01692275|147577838|SUPERIORITY||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-3.8|-0.4||||||Pensacola site (week 6) - RMDQ Between-Group Differences in Disability||-0.4|-3.8|
74013789|NCT01692275|147577838|SUPERIORITY||Mean Difference (Final Values)|-1.9|||||TWO_SIDED|95.0|-3.7|-0.2||||||Pensacola site (week 12) - RMDQ Between-Group Differences in Disability||-0.2|-3.7|
74013790|NCT01692275|147577838|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-4.3|-1.1||||||San Diego site (week 6) - RMDQ Between-Group Differences in Disability||-1.1|-4.3|
74013791|NCT01692275|147577838|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-4.4|-1.1||||||San Diego site (week 12) - RMDQ Between-Group Differences in Disability||-1.1|-4.4|
74013792|NCT01692275|147577839|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.6|-0.2||||||All sites combined (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.6|
74013793|NCT01692275|147577839|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.6|-0.2||||||All sites combined (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.6|
74013794|NCT01692275|147577839|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Walter Reed site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||0.1|-0.5|
74043076|NCT04153929|147637980|OTHER||Odds Ratio (OR)|17.68|||||TWO_SIDED|95.0|5.21|60.03|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||60.03|5.21|
74043077|NCT04153929|147637980|OTHER||Odds Ratio (OR)|25.87|||||TWO_SIDED|95.0|7.31|91.55|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||91.55|7.31|
74043078|NCT04153929|147637980|OTHER||Odds Ratio (OR)|21.75|||||TWO_SIDED|95.0|6.57|72.04|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||72.04|6.57|
74043079|NCT04153929|147637980|OTHER||Odds Ratio (OR)|35.0|||||TWO_SIDED|95.0|9.84|124.47|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||124.47|9.84|
74043080|NCT04153929|147637980|OTHER||Odds Ratio (OR)|8.22|||||TWO_SIDED|95.0|2.52|26.79|||||Odds Ratio was calculated as Semaglutide / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||26.79|2.52|
74013795|NCT01692275|147577839|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Walter Reed site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||0.1|-0.5|
74013796|NCT01692275|147577839|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||Pensacola site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.8|
74013797|NCT01692275|147577839|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||Pensacola site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.8|
74013798|NCT01692275|147577839|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.7|-0.2||||||San Diego site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.7|
74013799|NCT01692275|147577839|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.7|-0.1||||||San Diego site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.1|-0.7|
74013800|NCT01692275|147577840|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.6|-0.8||||||All sites combined (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.8|-1.6|
74013801|NCT01692275|147577840|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.6|-0.7||||||All sites combined (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.7|-1.6|
74013802|NCT01692275|147577840|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.3|-0.02||||||Walter Reed site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.02|-1.3|
74013803|NCT01692275|147577840|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-1.5|-0.1||||||Walter Reed site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.1|-1.5|
74013804|NCT01692275|147577840|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-2.0|-0.7||||||Pensacola site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.7|-2.0|
74094702|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.6|TWO_SIDED|95.0|-0.3|0.51|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.30|0.600
74013805|NCT01692275|147577840|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-2.3|-0.8||||||Pensacola site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.8|-2.3|
74013806|NCT01692275|147577840|SUPERIORITY||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-2.3|-1.0||||||San Diego site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-1.0|-2.3|
74013807|NCT01692275|147577840|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.9|-0.5||||||San Diego site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.5|-1.9|
74013808|NCT01692275|147577841|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.54|0.97||||||Week 6: All 3 sites combined||0.97|0.54|
74013809|NCT01692275|147577841|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.58|1.0||||||Week 12: All 3 sites combined||1.0|0.58|
74013810|NCT01692275|147577842|SUPERIORITY||Odds Ratio (OR)|0.18|||||TWO_SIDED|95.0|0.13|0.25||||||All sites combined: 6 weeks||0.25|0.13|
74013811|NCT01692275|147577842|SUPERIORITY||Odds Ratio (OR)|0.26|||||TWO_SIDED|95.0|0.16|0.42||||||Walter Reed site: 6 weeks||0.42|0.16|
74013812|NCT01692275|147577842|SUPERIORITY||Odds Ratio (OR)|0.18|||||TWO_SIDED|95.0|0.1|0.33||||||Naval Hospital Pensacola site: 6 weeks||0.33|0.10|
74013813|NCT01692275|147577842|SUPERIORITY||Odds Ratio (OR)|0.13|||||TWO_SIDED|95.0|0.08|0.21||||||Naval Medical Center San Diego site: 6 weeks||0.21|0.08|
74013814|NCT01692275|147577843|SUPERIORITY||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|2.1|2.8||||||All sites combined: 6 weeks||2.8|2.1|
74013815|NCT01692275|147577843|SUPERIORITY||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|1.4|2.6||||||Walter Reed site: 6 weeks||2.6|1.4|
74013816|NCT01692275|147577843|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|1.6|3.0||||||Naval Hospital Pensacola site: 6 weeks||3.0|1.6|
74013817|NCT01692275|147577843|SUPERIORITY||Mean Difference (Final Values)|3.1|||||TWO_SIDED|95.0|2.5|3.7||||||Naval Medical Center San Diego site: 6 weeks||3.7|2.5|
74013818|NCT03449095|147577896|SUPERIORITY||||||<|0.001||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|ANOVA|||||||<0.001
74013819|NCT03449095|147577897|SUPERIORITY|||||||0.001||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|ANCOVA|||||||.001
74013820|NCT04294901|147577995|SUPERIORITY||Odds Ratio (OR)|1.21||||0.008|TWO_SIDED|95.0|1.05|1.38|||Mixed Models Analysis|Binary mixed effect model with patients nested in providers nested in facilities||It is pre-specified in the Study Protocol and Statistical Analysis Plan to assess all medication groups combined within the Intervention and Control Arms/Groups.||1.38|1.05|0.008
74013821|NCT02813551|147578010|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.53|1.1||||||||1.10|0.53|
74013822|NCT02813551|147578011|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.4|3.3||||||||3.3|0.4|
74013823|NCT02813551|147578012|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|0.3|28.0||||||||28|0.3|
74013824|NCT02813551|147578013|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|1.0|1.3||||||||1.3|1.0|
74013825|NCT02813551|147578016|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|1.0|1.2||||||||1.2|1.0|
74013826|NCT02813551|147578017|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.5|1.9||||||||1.9|0.5|
74013827|NCT02813551|147578018|SUPERIORITY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.1|2.9||||||||2.9|0.1|
74013828|NCT02484911|147578037|SUPERIORITY_OR_OTHER|||||||0.397|||||||Chi-squared|||||||0.397
74094703|NCT02912650|147740348|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.447|TWO_SIDED|95.0|-0.17|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.17|0.447
74013829|NCT02484911|147578038|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
74013830|NCT02484911|147578040|SUPERIORITY_OR_OTHER|||||||0.397|||||||Chi-squared|||||||0.397
74013831|NCT02484911|147578041|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
74013832|NCT02484911|147578042|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
74013833|NCT02484911|147578043|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
74013834|NCT02484911|147578045|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
74013835|NCT02484911|147578046|SUPERIORITY_OR_OTHER|||||||0.283|||||||Chi-squared|||||||0.283
74043081|NCT04153929|147637981|OTHER||Odds Ratio (OR)|3.67|||||TWO_SIDED|95.0|0.14|95.73|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||95.73|0.14|
74043082|NCT04153929|147637981|OTHER||Odds Ratio (OR)|7.97|||||TWO_SIDED|95.0|0.39|163.56|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||163.56|0.39|
74013836|NCT02484911|147578047|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
74043083|NCT04153929|147637981|OTHER||Odds Ratio (OR)|25.17|||||TWO_SIDED|95.0|1.35|471.09|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||471.09|1.35|
73880058|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|5.58||||0.0038|TWO_SIDED|95.0|1.74|17.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.87|1.74|0.0038
74013837|NCT02484911|147578048|SUPERIORITY_OR_OTHER|||||||0.246|||||||Chi-squared|||||||0.246
74013838|NCT00812214|147578170|SUPERIORITY|For the purpose of the power calculation, it was assumed that the difference in total sleep time between the treatment groups is 40 minutes, with a standard deviation of 60. The pilot nature of the study allowed the use of alpha = 0.05 and beta = 0.2, with two-sided comparison, generating a required sample size of 37 subjects per arm.||||||0.33|||||||t-test, 2 sided|two-tailed student's t-test for independent samples||The null hypothesis is that there is no difference in the 6 week average total sleep time||||0.33
74013839|NCT00812214|147578171|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between the eszopiclone and placebo groups in the number of awakenings/night at 6 weeks.||||0.03
74013840|NCT00812214|147578173|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in sleep quality averaged over 6 weeks of treatment.||||0.1
74013841|NCT00812214|147578173|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime alertness averaged over 6 weeks of treatment.||||0.29
74013842|NCT00812214|147578173|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime fatigue averaged over 6 weeks of treatment.||||0.05
74013843|NCT00812214|147578173|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime functioning averaged over 6 weeks of treatment.||||0.76
74013844|NCT00812214|147578175|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in average days/week between eszopiclone and placebo groups at 6 weeks.||||0.89
74013845|NCT00812214|147578176|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in headache duration between eszopiclone and placebo groups at 6 weeks.||||0.98
74013846|NCT00812214|147578177|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in headache intensity between eszopiclone and placebo groups at 6 weeks.||||0.82
74013847|NCT01192022|147578179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|2.55|9.29||Logistic regression model with treatment and pooled center as factors.|Regression, Logistic|||||9.29|2.55|<0.001
74013848|NCT00129766|147578183|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval and relative risk adjusted for the stratification factor of presence or absence of CLD of prematurity as specified on the CRF.|Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.503|1.083|||t-test, 2 sided||Relative risk was calculated as (Pn/Ps) where Pn is the proportion of patients with RSV hospitalization in the motavizumab group and Ps is the proportion of patients with RSV hospitalization in the palivizumab group.|ITT population||1.083|0.503|
74013849|NCT00129766|147578192|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.11||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Cochran-Mantel-Haenszel|||||||0.110
74013850|NCT00129766|147578193|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.005||95.0||||No adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The CMH test was stratified by presence or absence of CLD of prematurity as specified on the CRF||||||0.005
74013851|NCT00129766|147578194|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.476||95.0|||||Van Eleteren test|Test stratified by presence or absence of CLD of prematurity specified on the CRF||P-value is for overall incidence||||0.476
74013852|NCT00129766|147578195|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.493||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test|||||||0.493
74043084|NCT04153929|147637981|OTHER||Odds Ratio (OR)|33.01|||||TWO_SIDED|95.0|1.78|613.51||||||Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||613.51|1.78|
73888021|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|20.1||||0.5808|TWO_SIDED|95.0|-51.6|91.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||91.8|-51.6|0.5808
74013853|NCT00129766|147578196|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.652||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test|||||||0.652
74013854|NCT00781456|147578206|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.02|STANDARD_ERROR_OF_MEAN|0.43||0.954|TWO_SIDED|95.0|-0.82|0.87|||Regression, Logistic|Logistic regression model with terms of treatment, weekly baseline migraine frequency, and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|||0.87|-0.82|0.954
74013855|NCT00781456|147578207|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|0.44||0.479|TWO_SIDED|95.0|-0.55|1.17||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the first month of treatment.||1.17|-0.55|0.479
74043085|NCT04153929|147637981|OTHER||Odds Ratio (OR)|42.44|||||TWO_SIDED|95.0|2.37|761.44|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||761.44|2.37|
74013856|NCT00781456|147578207|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.5|STANDARD_ERROR_OF_MEAN|0.44||0.256|TWO_SIDED|95.0|-0.36|1.37||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the second month of treatment||1.37|-0.36|0.256
74013857|NCT00781456|147578207|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.14|STANDARD_ERROR_OF_MEAN|0.52||0.788|TWO_SIDED|95.0|-1.16|0.88||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the third month of treatment.||0.88|-1.16|0.788
74013858|NCT00781456|147578208|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.19||||0.182|TWO_SIDED|95.0|-0.47|0.09|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the 91-day treatment period.||0.09|-0.47|0.182
74013859|NCT00781456|147578208|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.04||||0.853|TWO_SIDED|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the first month of treatment||0.19|-0.71|0.853
74013860|NCT00781456|147578208|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.26||||0.249|TWO_SIDED|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the second month of treatment||0.19|-0.71|0.249
74013861|NCT00781456|147578208|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.4||||0.119|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the third month of treatment||0.10|-0.90|0.119
74013862|NCT00781456|147578209|SUPERIORITY_OR_OTHER|||||||0.457|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the first month of treatment.||||0.457
74013863|NCT00781456|147578209|SUPERIORITY_OR_OTHER|||||||0.361|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the second month of treatment.||||0.361
74013864|NCT00781456|147578209|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the third month of treatment.||||0.018
74043086|NCT04153929|147637981|OTHER||Odds Ratio (OR)|84.53|||||TWO_SIDED|95.0|4.71|999.0|||||Odds Ratio was calculated as BI 456906 / Placebo. The upper limit is bigger than 999.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||999|4.71|
74043087|NCT04153929|147637981|OTHER||Odds Ratio (OR)|22.44|||||TWO_SIDED|95.0|1.22|413.33|||||Odds Ratio was calculated as Semaglutide / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||413.33|1.22|
74043088|NCT01963780|147637982|SUPERIORITY|Performance goal is 65%.|Proportion|0.544||||0.9663|TWO_SIDED|95.0|0.428|0.657|||one-sided exact binomial test|||||0.657|0.428|0.9663
74043089|NCT01963780|147637983|OTHER|No statistical hypothesis testing|Proportion|0.167|||||TWO_SIDED|95.0|0.092|0.268||||||||0.268|0.092|
74043090|NCT01963780|147637984|OTHER|No statistical hypothesis testing|Proportion|0.064|||||TWO_SIDED|95.0|0.021|0.143||||||||0.143|0.021|
74043091|NCT01963780|147637985|OTHER|No statistical hypothesis testing|Mean|0.3|||||TWO_SIDED|95.0|0.1|0.4||||||||0.4|0.1|
74043092|NCT02971293|147638044|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
74013865|NCT00781456|147578209|SUPERIORITY_OR_OTHER|||||||0.709|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the 91-day treatment period.||||0.709
74013866|NCT04091087|147578214|SUPERIORITY||Least square (LS) mean difference|-14.36|STANDARD_ERROR_OF_MEAN|7.47||0.0299|TWO_SIDED|90.0|-26.87|-1.86||1-sided|ANOVA|||||-1.86|-26.87|0.0299
74013867|NCT04091087|147578215|SUPERIORITY||Difference in percentage of participants|3.33||||0.1546|TWO_SIDED|90.0|-2.06|8.72||1-sided|Normal approximation test|||||8.72|-2.06|0.1546
74013868|NCT04091087|147578216|SUPERIORITY||Difference in percentage of participants|9.0||||0.0819|TWO_SIDED|90.0|-1.63|19.62||1-sided|Normal approximation test|||Week 1||19.62|-1.63|0.0819
74013869|NCT04091087|147578216|SUPERIORITY||Difference in percentage of participants|-0.47||||0.4789|TWO_SIDED|90.0|-15.2|14.25||1-sided|Normal approximation test|||Week 2||14.25|-15.20|0.4789
74013870|NCT04091087|147578216|SUPERIORITY||Difference in percentage of participants|-0.38||||0.4815|TWO_SIDED|90.0|-13.79|13.03||1-sided|Normal approximation test|||Week 3||13.03|-13.79|0.4815
74013871|NCT04091087|147578216|SUPERIORITY||Difference in percentage of participants|-0.38||||0.4815|TWO_SIDED|90.0|-13.79|13.03||1-sided|Normal approximation test|||Week 4||13.03|-13.79|0.4815
74013872|NCT04091087|147578216|SUPERIORITY||Difference in percentage of participants|8.9||||0.1197|TWO_SIDED|90.0|-3.55|21.35||1-sided|Normal approximation test|||Week 5||21.35|-3.55|0.1197
74013873|NCT04091087|147578216|SUPERIORITY||Difference in percentage of participants|18.18||||0.0034|TWO_SIDED|90.0|7.14|29.23||1-sided|Normal approximation test|||Week 6||29.23|7.14|0.0034
74013874|NCT04091087|147578217|SUPERIORITY||Difference in percentage of participants|5.13||||0.2896|TWO_SIDED|90.0|-10.09|20.34||1-sided|Normal approximation test|||||20.34|-10.09|0.2896
74013875|NCT04091087|147578218|SUPERIORITY||Difference in percentage of participants|7.77||||0.2648|TWO_SIDED|90.0|-12.55|28.08||1-sided|Normal approximation test|||Week 1||28.08|-12.55|0.2648
74013876|NCT04091087|147578218|SUPERIORITY||Difference in percentage of participants|17.05||||0.0809|TWO_SIDED|90.0|-2.99|37.08||1-sided|Normal approximation test|||Week 2||37.08|-2.99|0.0809
74013877|NCT04091087|147578218|SUPERIORITY||Difference in percentage of participants|1.7||||0.445|TWO_SIDED|90.0|-18.58|21.99||1-sided|Normal approximation test|||Week 3||21.99|-18.58|0.4450
74013878|NCT04091087|147578218|SUPERIORITY||Difference in percentage of participants|1.7||||0.445|TWO_SIDED|90.0|-18.58|21.99||1-sided|Normal approximation test|||Week 4||21.99|-18.58|0.4450
74013879|NCT04091087|147578218|SUPERIORITY||Difference in percentage of participants|20.45||||0.0385|TWO_SIDED|90.0|1.43|39.48||1-sided|Normal approximation test|||Week 5||39.48|1.43|0.0385
74013880|NCT04091087|147578218|SUPERIORITY||Difference in percentage of participants|29.64||||0.0045|TWO_SIDED|90.0|10.95|48.33||1 sided|Normal approximation test|||Week 6||48.33|10.95|0.0045
74013881|NCT04091087|147578219|SUPERIORITY||LS mean Difference|3.88|STANDARD_ERROR_OF_MEAN|13.49||0.3874|TWO_SIDED|90.0|-18.67|26.43||1-sided|Normal approximation test|||Week 1||26.43|-18.67|0.3874
74013882|NCT04091087|147578219|SUPERIORITY||LS mean Difference|-4.47|STANDARD_ERROR_OF_MEAN|11.59||0.3506|TWO_SIDED|90.0|-23.85|14.91||1-sided|Normal approximation test|||Week 2||14.91|-23.85|0.3506
74013883|NCT04091087|147578219|SUPERIORITY||LS mean Difference|9.81|STANDARD_ERROR_OF_MEAN|14.23||0.2466|TWO_SIDED|90.0|-13.97|33.6||1-sided|Normal approximation test|||Week 3||33.60|-13.97|0.2466
74013884|NCT04091087|147578219|SUPERIORITY||LS mean Difference|34.74|STANDARD_ERROR_OF_MEAN|15.74||0.0157|TWO_SIDED|90.0|8.43|61.05||1-sided|Normal approximation test|||Week 4||61.05|8.43|0.0157
74013885|NCT04091087|147578219|SUPERIORITY||LS mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|14.55||0.4548|TWO_SIDED|90.0|-25.99|22.68||1-sided|Normal approximation test|||Week 5||22.68|-25.99|0.4548
74013886|NCT04091087|147578219|SUPERIORITY||LS mean Difference|-42.19|STANDARD_ERROR_OF_MEAN|11.99||0.0004|TWO_SIDED|90.0|-62.24|-22.15||1-sided|Normal approximation test|||Week 6||-22.15|-62.24|0.0004
74013887|NCT04091087|147578220|SUPERIORITY||LS mean difference|6.91|STANDARD_ERROR_OF_MEAN|9.65||0.2383|TWO_SIDED|90.0|-9.23|23.06||1 sided|ANOVA|||||23.06|-9.23|0.2383
74013888|NCT04091087|147578221|SUPERIORITY||LS mean Difference|-29.95|STANDARD_ERROR_OF_MEAN|21.01||0.0797|TWO_SIDED|90.0|-65.09|5.18||1-sided|Normal approximation test|||Week 1||5.18|-65.09|0.0797
74013889|NCT04091087|147578221|SUPERIORITY||LS mean Difference|-14.39|STANDARD_ERROR_OF_MEAN|18.79||0.2236|TWO_SIDED|90.0|-45.81|17.04||1-sided|Normal approximation test|||Week 2||17.04|-45.81|0.2236
74013890|NCT04091087|147578221|SUPERIORITY||LS mean Difference|-9.94|STANDARD_ERROR_OF_MEAN|15.05||0.2559|TWO_SIDED|90.0|-35.12|15.24||1-sided|Normal approximation test|||Week 3||15.24|-35.12|0.2559
74013891|NCT04091087|147578221|SUPERIORITY||LS mean Difference|-16.01|STANDARD_ERROR_OF_MEAN|22.44||0.2392|TWO_SIDED|90.0|-53.54|21.52||1-sided|Normal approximation test|||Week 4||21.52|-53.54|0.2392
74013892|NCT04091087|147578221|SUPERIORITY||LS mean Difference|-13.01|STANDARD_ERROR_OF_MEAN|19.65||0.2553|TWO_SIDED|90.0|-45.87|19.85||1-sided|Normal approximation test|||Week 5||19.85|-45.87|0.2553
74013893|NCT04091087|147578221|SUPERIORITY||LS mean Difference|-53.01|STANDARD_ERROR_OF_MEAN|30.05||0.0416|TWO_SIDED|90.0|-103.26|-2.75||1-sided|Normal approximation test|||Week 6||-2.75|-103.26|0.0416
74013894|NCT04152161|147578228|SUPERIORITY||Vaccine Efficacy|-0.049|||||TWO_SIDED|95.0|-0.431|0.23|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.230|-0.431|
74013895|NCT04152161|147578228|SUPERIORITY||Hazard Ratio (HR)|1.049||||0.6193|TWO_SIDED|95.0|0.77|1.431|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.431|0.770|0.6193
74013896|NCT04152161|147578229|SUPERIORITY||Vaccine Efficacy|-0.009|||||TWO_SIDED|95.0|-0.395|0.27|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.270|-0.395|
74013897|NCT04152161|147578229|SUPERIORITY||Hazard Ratio (HR)|1.009||||0.5224|TWO_SIDED|95.0|0.73|1.395|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.395|0.730|0.5224
74013898|NCT04152161|147578230|SUPERIORITY||Vaccine Efficacy|-0.049|||||TWO_SIDED|95.0|-0.431|0.23|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.230|-0.431|
74013899|NCT04152161|147578230|SUPERIORITY||Hazard Ratio (HR)|1.049||||0.6193|TWO_SIDED|95.0|0.77|1.431|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.431|0.770|0.6193
74013900|NCT00440947|147578264|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) on the difference in the percentage of participants with HIV-1 RNA \<50 c/mL at Week 84 was -12% or greater.|Risk Difference (RD)|5.4||||0.14|TWO_SIDED|95.0|-1.8|12.5|||Cochran-Mantel-Haenszel|p-value was obtained from Cochran-Mantel-Haenszel stratified by baseline HIV-1 RNA (\<100000/\>=100000)||||12.5|-1.8|0.140
74013901|NCT02017327|147578314|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74013902|NCT02017327|147578314|SUPERIORITY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||||||0.0045
74013903|NCT02813694|147578328|NON_INFERIORITY|non-inferiority margin= 10%|Treatment difference|0.1|||||TWO_SIDED|95.0|-4.4|4.5|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic|||4.5|-4.4|
74013904|NCT02813694|147578329|NON_INFERIORITY|non-inferiority margin = 10%|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.3|3.1|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.1|-6.3|
74013905|NCT02813694|147578329|NON_INFERIORITY|non-inferiority margain = 10%|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.5|3.3|||||Difference in percentage of Success for IACR at test of cure visit. Confidence interval computed using a continuity-corrected Z-test.|||3.3|-6.5|
74013906|NCT02813694|147578330|NON_INFERIORITY|non-inferiority margain = 10%|Treatment difference|-3.9|||||TWO_SIDED|95.0|-8.2|0.5|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\]; PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||0.5|-8.2|
74013907|NCT02813694|147578330|NON_INFERIORITY|non-inferiority margin = 10%|Treatment difference|-3.9|||||TWO_SIDED|95.0|-8.4|0.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic.|||0.7|-8.4|
74013908|NCT01265797|147578331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare outcome measures between two treatment groups in the run-in month minus blinded month||The a priori alpha level was set at p \< 0.05, and a power of 0.80 (80%) was used to compute the number of subjects needed to find a meaningful difference between the verum and sham groups. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group.||||0.30
74013909|NCT01265797|147578332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.89|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare secondary outcome measures between two treatment groups in the run-in month minus open label month||||||0.89
74013910|NCT01265797|147578333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
74013911|NCT01265797|147578334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.98|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare the primary and secondary outcome measures between the two treatment groups.||The a priori alpha level was set at p \< 0.05, and beta 0.2. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group. The null hypothesis: No difference in the depression score/14 day recall between the two groups.||||0.98
74013912|NCT01265797|147578335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.75
74013913|NCT01265797|147578336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
74013914|NCT01265797|147578337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.02|TWO_SIDED|||||Change in mean anxiety score/ 14 day recall from the blinded period to open label period|Wilcoxon (Mann-Whitney)|||||||0.02
74043093|NCT02971293|147638044|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
74043094|NCT02971293|147638044|SUPERIORITY|||||||0.02|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.020
74043095|NCT02971293|147638056|SUPERIORITY|||||||0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.002
74043096|NCT02971293|147638056|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
74043097|NCT02971293|147638056|SUPERIORITY|||||||0.011|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.011
74043098|NCT02971293|147638057|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
74043099|NCT02971293|147638057|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
74013915|NCT01265797|147578338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.98|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.98
74013916|NCT01265797|147578339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.97
74013917|NCT01265797|147578340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.87
74013918|NCT01265797|147578341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.83
74013919|NCT01265797|147578342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.92|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.92
74013920|NCT02595723|147578356|OTHER|||||||0.003||||||Overall group difference adjusted for prior group, time, and baseline values.|Mixed Models Analysis|Model includes prior group, time, and baseline values to control for possible effects.||||||0.003
74013921|NCT01087905|147578370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.076|TWO_SIDED|95.0|0.98|1.61|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) versus Six Weeks of Nicotine Replacement Therapy (NRT). We hypothesized that Six Weeks of NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT)."||1.61|0.98|.076
74013922|NCT01087905|147578370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.017|TWO_SIDED|95.0|1.06|1.75|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving NRT Monotherapy (Nicotine Patch Only) versus NRT Combination Therapy (Nicotine Patch plus Nicotine Gum). We hypothesized that Combination NRT would result in statistically significantly higher abstinence rates compared to NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Combination NRT)."||1.75|1.06|.017
74043100|NCT02971293|147638057|SUPERIORITY|||||||0.201|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.201
74043101|NCT02971293|147638058|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
74043102|NCT02971293|147638058|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
74043103|NCT02971293|147638058|SUPERIORITY|||||||0.02|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.020
74043104|NCT02971293|147638059|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
74043105|NCT02971293|147638059|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
74043106|NCT02971293|147638059|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||<0.001
74043107|NCT02971293|147638060|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
74043108|NCT02971293|147638060|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
74043109|NCT02971293|147638060|SUPERIORITY|||||||0.092|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.092
74043110|NCT02971293|147638061|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
74043111|NCT02971293|147638061|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
74043112|NCT02971293|147638061|SUPERIORITY|||||||0.279|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.279
74043113|NCT02971293|147638062|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
74043114|NCT02971293|147638062|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
74043115|NCT02971293|147638062|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||<0.001
74043116|NCT02971293|147638063|SUPERIORITY|||||||0.205|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.205
74043117|NCT02971293|147638063|SUPERIORITY|||||||0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.002
74094704|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.001|TWO_SIDED|95.0|0.23|0.96|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.96|0.23|0.001
74094705|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.297|TWO_SIDED|95.0|-0.12|0.39|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.39|-0.12|0.297
74094706|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.457|TWO_SIDED|95.0|-0.35|0.16|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.16|-0.35|0.457
74094707|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.012|TWO_SIDED|95.0|0.1|0.82|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.82|0.10|0.012
73880059|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.09||||0.1424|TWO_SIDED|95.0|0.78|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.60|0.78|0.1424
74013923|NCT01087905|147578370|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.343|TWO_SIDED|95.0|0.69|1.14|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Standard Cessation Counseling (No CMAC) versus Standard Cessation Counseling plus CMAC. We hypothesized that Standard Counseling plus CMAC would result in statistically significantly higher abstinence rates compared to Standard Counseling Only.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Standard Counseling plus CMAC)."||1.14|0.69|.343
74043118|NCT02971293|147638063|SUPERIORITY|||||||0.06|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.060
74043119|NCT02971293|147638064|SUPERIORITY|||||||0.111|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.111
74043120|NCT02971293|147638064|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
74043121|NCT02971293|147638064|SUPERIORITY|||||||0.015|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.015
74043122|NCT02971293|147638065|SUPERIORITY|||||||0.621|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.621
74043123|NCT02971293|147638065|SUPERIORITY|||||||0.138|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.138
74043124|NCT02971293|147638065|SUPERIORITY|||||||0.333|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.333
74043125|NCT02971293|147638066|SUPERIORITY|||||||0.748|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.748
74043126|NCT02971293|147638066|SUPERIORITY|||||||0.005|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.005
74043127|NCT02971293|147638066|SUPERIORITY|||||||0.013|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.013
74043128|NCT02971293|147638067|SUPERIORITY|||||||0.064|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.064
74043129|NCT02971293|147638067|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
74043130|NCT02971293|147638067|SUPERIORITY|||||||0.03|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.030
74043131|NCT02971293|147638068|SUPERIORITY|||||||0.018|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.018
74043132|NCT02971293|147638068|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
74043133|NCT02971293|147638068|SUPERIORITY|||||||0.047|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.047
74043134|NCT02971293|147638069|SUPERIORITY|||||||0.477|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.477
74043135|NCT02971293|147638069|SUPERIORITY|||||||0.014|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.014
74043136|NCT02971293|147638069|SUPERIORITY|||||||0.084|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.084
74013924|NCT01087905|147578371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.029|TWO_SIDED|95.0|1.04|2.14|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Two Weeks of Combination NRT (Patch+Gum). We hypothesized that Two Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||2.14|1.04|.029
74013925|NCT01087905|147578371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.079|TWO_SIDED|95.0|0.96|1.97|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus SIx Weeks of NRT Monotherapy. We hypothesized that Six Weeks of NRT Monotherapy would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||1.97|0.96|.079
74013926|NCT01087905|147578371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.003|TWO_SIDED|95.0|1.2|2.45|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Six Weeks of Combination NRT (Patch+Gum). We hypothesized that Six Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||2.45|1.20|.003
74013927|NCT01087905|147578372|SUPERIORITY_OR_OTHER||incremental cost-effectiveness ratio|357.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.||||
74013928|NCT01087905|147578372|SUPERIORITY_OR_OTHER||Incremental cost-effectiveness ratio|712.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch only = (233-178)/(.462-.384) = $712.||||
74013929|NCT01087905|147578372|SUPERIORITY_OR_OTHER||Incremental cost-effectiveness ratio|1290.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the Incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch and nicotine gum = (348-178)/(.516-.384) = $1290.||||
73880060|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0191|TWO_SIDED|95.0|1.22|9.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.07|1.22|0.0191
74013930|NCT00004259|147578390|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.36|TWO_SIDED|95.0|0.67|1.32|||Log Rank|||The hypothesized median survival time was 36 months for the RT+BCNU/CCNU arm and 54 months for the RT+TMZ arm, corresponding to a hazard ratio (HR) of 0.67. A sample size of 216 evaluable patients per arm would provide 90% power with a one-sided significance level of 0.05. The final analysis was planned after 155 deaths were observed. Interim efficacy analyses were planned after 52 and 104 deaths, with an interim futility analysis planned at 128 deaths.||1.32|0.67|0.36
74013931|NCT00004259|147578392|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.46|TWO_SIDED|95.0|0.55|1.16||2-sided|Gray's test||Reference level = RT + BCNU/CCNU|||1.16|0.55|0.46
74043137|NCT02971293|147638070|SUPERIORITY|||||||0.213|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.213
73880061|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0244|TWO_SIDED|95.0|1.16|8.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.56|1.16|0.0244
74043138|NCT02971293|147638070|SUPERIORITY|||||||0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.001
74043139|NCT02971293|147638070|SUPERIORITY|||||||0.046|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.046
74043140|NCT00729326|147638072|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-values were not adjusted. The primary measure was change in 24-hour glucose without multiplicity adjustments for other analyses.|ANCOVA|Analyses for continuous variables adjusted for treatment, period, sequence, baseline of the continuous variable.Analysis method was Grizzle's model.||Null hypothesis: The 24-hour average glucose for exenatide was greater than or equal to that for sitagliptin after 4 weeks of treatment. The primary objective was to compare exenatide with sitagliptin on the time-averaged glucose during the 24-hour inpatient periods after 4 weeks of treatment.||||<.001
74013932|NCT00004259|147578393|SUPERIORITY||||||<|0.001||||||2-sided|Chi-squared|||Overall toxicity||||<0.001
74013933|NCT00004259|147578393|SUPERIORITY|||||||0.76||||||2-sided|Chi-squared|||Non-hematologic toxicity||||0.76
74013934|NCT00004259|147578394|SUPERIORITY||Hazard Ratio (HR)|1.78||||0.08|TWO_SIDED|95.0|0.93|3.4|||Log Rank|Two-side significance level = 0.05|Reference level = Methylated MGMT|||3.40|0.93|0.08
74013935|NCT00004259|147578395|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.41|TWO_SIDED|95.0|0.7|2.35|||Log Rank|Two-sided confidence interval = 0.5|Reference level = Methylated|||2.35|0.70|0.41
74013936|NCT00385255|147578417|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentages of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|1.06|||||TWO_SIDED|95.0|-1.36|3.56||||||Difference in seroprotection rates against diphteria toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-D antibody, one month post-Boostrix® vaccination.||3.56|-1.36|
74013937|NCT00385255|147578417|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+ Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|-1.67|||||TWO_SIDED|95.0|-2.96|-0.74||||||Difference in seroprotection rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-T antibody, one month post-Boostrix® vaccination.||-0.74|-2.96|
74013938|NCT00385255|147578418|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 1.0 IU/mL, being ≥ - 10%.|Difference in percentage|1.4|||||TWO_SIDED|95.0|-0.77|3.68||||||Difference in seropositivity rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seropositivity rates for anti-T antibody, one month post-Boostrix® vaccination.||3.68|-0.77|
74013939|NCT00385255|147578419|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertussis toxoid (PT) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82|||ANCOVA|||Difference in adjusted GMC ratios for anti-PT antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PT antibody, one month post-Boostrix® vaccination.||0.82|0.67|
74043141|NCT00729326|147638073|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
74013940|NCT00385255|147578419|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the filamentous hemagglutinin (FHA) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.71|||||TWO_SIDED|95.0|0.64|0.79|||ANCOVA|||Difference in adjusted GMC ratio for anti-FHA antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-FHA antibody, one month post-Boostrix® vaccination.||0.79|0.64|
74013941|NCT00385255|147578419|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertactin (PRN) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.7|||||TWO_SIDED|95.0|0.6|0.81|||ANCOVA|||Difference in adjusted GMC ratio for anti-PRN antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PRN antibody, one month post-Boostrix® vaccination.||0.81|0.60|
74013942|NCT00385255|147578420|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-1.17|||||TWO_SIDED|95.0|-3.58|1.23||||||Difference in percentage of subjects with anti-H1N1 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||1.23|-3.58|
74043142|NCT00729326|147638074|SUPERIORITY_OR_OTHER|||||||0.766||95.0|||||ANCOVA|||||||.766
74043143|NCT00729326|147638075|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
74043144|NCT00729326|147638076|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
74043145|NCT00729326|147638077|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||ANCOVA|||||||.117
74043146|NCT00729326|147638078|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
74043147|NCT00729326|147638079|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
74043148|NCT00729326|147638080|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
74043149|NCT00729326|147638081|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
74043150|NCT00729326|147638082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
74043151|NCT00729326|147638083|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
74043152|NCT00729326|147638084|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
74013943|NCT00385255|147578420|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.61|||||TWO_SIDED|95.0|-2.22|0.96||||||Difference in percentage of subjects with anti-H3N2 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||0.96|-2.22|
74043153|NCT00871572|147638110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0296|TWO_SIDED|90.0|-1.64|-0.23|||Mixed Models Analysis|||||-0.23|-1.64|0.0296
74043154|NCT00871572|147638110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0418|TWO_SIDED|90.0|-1.37|-0.15|||Mixed Models Analysis|||||-0.15|-1.37|0.0418
74043155|NCT00871572|147638110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0514|TWO_SIDED|90.0|-1.41|-0.12|||Mixed Models Analysis|||||-0.12|-1.41|0.0514
74043156|NCT00871572|147638111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.2565|TWO_SIDED|95.0|-4.46|1.21|||Mixed Models Analysis|||||1.21|-4.46|0.2565
74043157|NCT00871572|147638111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.1245|TWO_SIDED|95.0|-4.25|0.53|||Mixed Models Analysis|||||0.53|-4.25|0.1245
74043158|NCT00871572|147638111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.0594|TWO_SIDED|95.0|-4.92|0.1|||Mixed Models Analysis|||||0.10|-4.92|0.0594
74043159|NCT00871572|147638112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-124.56||||0.4978|TWO_SIDED|95.0|-490.02|240.9|||ANCOVA|||||240.90|-490.02|0.4978
74043160|NCT00871572|147638112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-338.64||||0.0372|TWO_SIDED|95.0|-656.55|-20.72|||ANCOVA|||||-20.72|-656.55|0.0372
74043161|NCT00871572|147638112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-466.83||||0.0068|TWO_SIDED|95.0|-799.48|-134.18|||ANCOVA|||||-134.18|-799.48|0.0068
74043162|NCT00871572|147638113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.814|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.814
74043163|NCT00871572|147638113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.681|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||||0.7|-0.4|0.681
74043164|NCT00871572|147638113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.715|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||||0.5|-0.7|0.715
74043165|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.56||||0.0248|TWO_SIDED|95.0|-44.03|-3.09||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-3.09|-44.03|0.0248
74043166|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.28||||0.0002|TWO_SIDED|95.0|-53.08|-17.48||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-17.48|-53.08|0.0002
74043167|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.32|||<|0.0001|TWO_SIDED|95.0|-58.12|-20.53||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-20.53|-58.12|<0.0001
74043168|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42||||0.6513|TWO_SIDED|95.0|-34.66|21.82||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||21.82|-34.66|0.6513
74043169|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.5045|TWO_SIDED|95.0|-32.61|16.21||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||16.21|-32.61|0.5045
74043170|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2||||0.5774|TWO_SIDED|95.0|-32.9|18.49||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||18.49|-32.90|0.5774
74043171|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.81||||0.0045|TWO_SIDED|95.0|-60.1|-11.53||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-11.53|-60.10|0.0045
74043172|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.15||||0.0024|TWO_SIDED|95.0|-54.1|-12.21||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-12.21|-54.10|0.0024
74043173|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.87||||0.0011|TWO_SIDED|95.0|-59.98|-15.75||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-15.75|-59.98|0.0011
74043174|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.48||||0.0389|TWO_SIDED|95.0|-55.47|-1.49||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||-1.49|-55.47|0.0389
74043175|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65||||0.1896|TWO_SIDED|95.0|-39.24|7.94||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||7.94|-39.24|0.1896
74043176|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.56||||0.0729|TWO_SIDED|95.0|-47.28|2.16||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||2.16|-47.28|0.0729
74043177|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.78||||0.0041|TWO_SIDED|95.0|-74.79|-14.77||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-14.77|-74.79|0.0041
74043178|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.45|||<|0.0001|TWO_SIDED|95.0|-80.42|-28.48||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-28.48|-80.42|<0.0001
74043179|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.19||||0.0013|TWO_SIDED|95.0|-73.57|-18.81||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-18.81|-73.57|0.0013
74043180|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.82||||0.0118|TWO_SIDED|95.0|-70.51|-9.13||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-9.13|-70.51|0.0118
74043181|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.8||||0.0016|TWO_SIDED|95.0|-70.42|-17.18||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-17.18|-70.42|0.0016
74013944|NCT00385255|147578420|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.55|||||TWO_SIDED|95.0|-2.52|1.42||||||Difference in percentage of subjects with anti-B antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||1.42|-2.52|
74013945|NCT00385255|147578421|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H1N1 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.37|||||TWO_SIDED|95.0|-2.84|7.58||||||Difference in seroconversion rates for anti-H1N1 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H1N1 antibody, one month post-Fluarix® vaccination.||7.58|-2.84|
73880062|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.63||||0.1462|TWO_SIDED|95.0|0.71|9.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.67|0.71|0.1462
74013946|NCT00385255|147578421|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H3N2 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|5.58|||||TWO_SIDED|95.0|1.1|10.07||||||Difference in seroconversion rates for anti-H3N2 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H3N2 antibody, one month post-Fluarix® vaccination.||10.07|1.10|
74013947|NCT00385255|147578421|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase anti-B antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.15|||||TWO_SIDED|95.0|-2.9|7.2||||||Difference in seroconversion rates for anti-B antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-B antibody, one month post-Fluarix® vaccination.||7.20|-2.90|
74013948|NCT02079987|147578463|SUPERIORITY|||||||0.49|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.||||||0.49
74013949|NCT02079987|147578464|SUPERIORITY|||||||0.23|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.||||||0.23
74013950|NCT02079987|147578465|SUPERIORITY|||||||0.25||||||A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.|difference-in-difference analysis|||||||0.25
74013951|NCT02079987|147578466|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
74013952|NCT02079987|147578467|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.57
73880063|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7403|TWO_SIDED|95.0|0.32|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.97|0.32|0.7403
74013953|NCT02079987|147578468|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
74013954|NCT01445951|147578473|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with 0.4 margin|Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|95.0|0.02|0.36||||||MMRM (mixed model repeated measures) model with auto-regression (1): HbA1c = Baseline HbA1c + region + basal insulin stratum + visit + treatment + (visit\*treatment)||0.36|0.02|
74013955|NCT01445951|147578474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.016|||TWO_SIDED|95.0|-0.02|0.04|||||Mixed Model Repeated Measure (MMRM): FEV1 = Baseline FEV1 + Age + Gender + Race + Baseline Height + Visit + Treatment + (Visit\*Treatment)|||0.04|-0.02|
74013956|NCT01445951|147578475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.42|STANDARD_ERROR_OF_MEAN|10.622|||TWO_SIDED|95.0|-56.25|-14.59|||||MMRM: FPG = Baseline FPG + Region + Basal insulin stratum + Visit + Treatment + (Visit\*Treatment)|||-14.59|-56.25|
74043182|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.56||||0.0065|TWO_SIDED|95.0|-67.63|-11.48||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-11.48|-67.63|0.0065
74043183|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.88||||0.0154|TWO_SIDED|95.0|-66.43|-7.33||P-value is for Bedtime.|Mixed Models Analysis|||||-7.33|-66.43|0.0154
74043184|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.5||||0.0006|TWO_SIDED|95.0|-71.93|-21.07||P-value is for Bedtime.|Mixed Models Analysis|||||-21.07|-71.93|0.0006
74043185|NCT00871572|147638116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.07||||0.0029|TWO_SIDED|95.0|-69.13|-15.01||P-value is for Bedtime.|Mixed Models Analysis|||||-15.01|-69.13|0.0029
74043186|NCT00871572|147638117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.62||||0.3815|TWO_SIDED|95.0|-32.44|83.68|||Mixed Models Analysis|||||83.68|-32.44|0.3815
74043187|NCT00871572|147638117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4||||0.8315|TWO_SIDED|95.0|-45.12|55.93|||Mixed Models Analysis|||||55.93|-45.12|0.8315
74043188|NCT00871572|147638117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.25||||0.3658|TWO_SIDED|95.0|-28.93|77.44|||Mixed Models Analysis|||||77.44|-28.93|0.3658
74043189|NCT00871572|147638118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|55.06||||0.2131|TWO_SIDED|95.0|-32.24|142.37|||Mixed Models Analysis|||||142.37|-32.24|0.2131
74013957|NCT01445951|147578478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.512||0.0102|TWO_SIDED|95.0|-2.33|-0.31|||ANCOVA|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment|||-0.31|-2.33|0.0102
74013958|NCT01445951|147578478|SUPERIORITY_OR_OTHER|||||||0.4955|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.4955
74013959|NCT01445951|147578478|SUPERIORITY_OR_OTHER|||||||0.6807|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.6807
74013960|NCT01445951|147578478|SUPERIORITY_OR_OTHER|||||||0.0079|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.0079
74013961|NCT01445951|147578480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5328||||0.0156|TWO_SIDED|95.0|0.3198|0.8877|||Regression, Logistic|Logistic model with affects for Region, Basal insulin stratum, and Treatment||||0.8877|0.3198|0.0156
74013962|NCT01445951|147578481|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time||||||<0.0001
74013963|NCT01445951|147578482|SUPERIORITY_OR_OTHER|||||||0.1022|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time||||||0.1022
74013964|NCT01445951|147578483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.449||||0.0158|TWO_SIDED|95.0|0.23|0.86|||Regression, Logistic|Model: Treatment + Basal insulin stratum + Region + Baseline HbA1c|Gen2 in the numerator, Aspart in the denominator|||0.86|0.23|0.0158
74013965|NCT01627860|147578494|SUPERIORITY_OR_OTHER||Difference in Seizure free rate|23.57||||0.0759|TWO_SIDED|95.0|-4.21|49.0|||ANOVA||Difference in Seizure free rate (Monotherapy minus Add on therapy)|||49.00|-4.21|0.0759
74013966|NCT01627860|147578495|SUPERIORITY_OR_OTHER||Difference in mean percent change|18.3||||0.7102|TWO_SIDED|95.0|-81.0|117.7|||ANCOVA||Difference in mean percent change of seizure frequency (Monotherapy minus Add on therapy)|||117.7|-81.0|0.7102
74013967|NCT02076997|147578498|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74013968|NCT02076997|147578504|OTHER|||||||||||||||||There was no statistical analysis performed for this aim as it was descriptive|There was no statistical analysis performed for this aim as it was descriptive|||
74013969|NCT02076997|147578505|OTHER||Odds Ratio (OR)|6.7|||||TWO_SIDED|95.0||||||||||||
74013970|NCT02533063|147578506|SUPERIORITY|||||||0.217|||||||ANOVA|||||||0.217
74013971|NCT02533063|147578507|SUPERIORITY|||||||0.501|||||||ANOVA|||||||0.501
74013972|NCT02533063|147578508|SUPERIORITY|||||||0.151|||||||ANOVA|||||||0.151
74013973|NCT02533063|147578509|SUPERIORITY|||||||0.45|||||||ANOVA|||||||0.450
74013974|NCT02533063|147578510|SUPERIORITY|||||||0.678|||||||ANOVA|||||||0.678
74013975|NCT02533063|147578511|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.060
74013976|NCT02533063|147578514|SUPERIORITY|||||||0.483|||||||ANOVA|||||||0.483
74013977|NCT00677014|147578515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.66||95.0|||||ANOVA|As LVESV values were non normal by Q-Q analysis and Shapiro-Wilk test (p\<.05), a square root transform was used. model adjusted for baseline LVESV.||Gate keeping strategy utilized for Type 1 error control described in design paper - negative results observed for initial comparisons - (each at alpha = .05) between fixed and algorithm optimized AV delay and fixed and Echo optimzied AV. Results from both of these comparisons were non-significant.||||.66
74013978|NCT02374099|147578543|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.599|TWO_SIDED|95.0|0.54|1.42|||Log Rank||||Hazard ratio and associated two-sided 95% confidence intervals (CI) were estimated by the Cox proportional hazard models.|1.42|0.54|= 0.599
74013979|NCT02374099|147578544|SUPERIORITY||Difference in Response Rates|6.3|||=|0.1479|TWO_SIDED|95.0|-2.47|15.06|||Fisher Exact||||The two-sided 95% confidence interval for the difference in ORR was estimated by the Wilson method.|15.06|-2.47|= 0.1479
74013980|NCT02374099|147578545|SUPERIORITY||Difference in Clinical Benefit Rate|0.7|||=|0.1732|TWO_SIDED|95.0|-17.76|19.04|||Fisher Exact||||The two-sided 95% confidence interval for the difference in clinical benefit rate was estimated by the Wilson method.|19.04|-17.76|= 0.1732
74013981|NCT02374099|147578546|SUPERIORITY||Hazard Ratio (HR)|0.59|||=|0.2725|TWO_SIDED|95.0|0.23|1.53|||Log Rank||||Hazard Ratio and associated two-sided 95% CI were estimated by the Cox proportional hazard model.|1.53|0.23|= 0.2725
74013982|NCT01033825|147578577|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-0.5|||>|0.05|TWO_SIDED|95.0|-13.9|13.0|||ANCOVA||Null Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\>=38 Alternative Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\<38|Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||13.0|-13.9|>0.05
74043190|NCT00871572|147638118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|89.68||||0.022|TWO_SIDED|95.0|13.27|166.1|||Mixed Models Analysis|||||166.10|13.27|0.0220
74043191|NCT00871572|147638118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|107.26||||0.0101|TWO_SIDED|95.0|26.29|188.22|||Mixed Models Analysis|||||188.22|26.29|0.0101
74043192|NCT00871572|147638119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87||||0.1596|TWO_SIDED|95.0|-0.75|4.49|||Mixed Models Analysis|||||4.49|-0.75|0.1596
74043193|NCT00871572|147638119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.0791|TWO_SIDED|95.0|-0.24|4.31|||Mixed Models Analysis|||||4.31|-0.24|0.0791
74043194|NCT00871572|147638119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.1564|TWO_SIDED|95.0|-0.67|4.1|||Mixed Models Analysis|||||4.10|-0.67|0.1564
74043195|NCT00871572|147638120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8018.51||||0.45|TWO_SIDED|95.0|-13104.14|29141.16|||ANCOVA|||||29141.16|-13104.14|0.4500
74043196|NCT00871572|147638120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5174.85||||0.5739|TWO_SIDED|95.0|-13158.65|23508.35|||ANCOVA|||||23508.35|-13158.65|0.5739
74043197|NCT00871572|147638120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18153.92||||0.0653|TWO_SIDED|95.0|-1188.23|37496.06|||ANCOVA|||||37496.06|-1188.23|0.0653
74013983|NCT01033825|147578577|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-2.4||||0.025|TWO_SIDED|95.0|-15.1|10.2|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||10.2|-15.1|0.025
74013984|NCT01033825|147578577|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide nasal spray 200 μg to placebo nasal spray 46 evaluable (per protocol) subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL|Mean Difference (Final Values)|10.4|||>|0.05|TWO_SIDED|95.0|-4.7|25.5|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||25.5|-4.7|>0.05
74013985|NCT00894556|147578638|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.||||||<0.001
74013986|NCT00894556|147578639|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.||||||<0.001
74094708|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.33|1.06|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.06|0.33|<0.001
74094709|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23||||0.076|TWO_SIDED|95.0|-0.49|0.02|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.02|-0.49|0.076
74094710|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|2.03|||<|0.001|TWO_SIDED|95.0|1.42|2.63|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.63|1.42|<0.001
74094711|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.016|TWO_SIDED|95.0|0.1|0.93|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.93|0.10|0.016
74043198|NCT00871572|147638121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18094.32||||0.6209|TWO_SIDED|95.0|-54734.08|90922.71|||ANCOVA|||||90922.71|-54734.08|0.6209
74043199|NCT00871572|147638121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5783.59||||0.8581|TWO_SIDED|95.0|-58650.71|70217.89|||ANCOVA|||||70217.89|-58650.71|0.8581
74043200|NCT00871572|147638121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36218.98||||0.285|TWO_SIDED|95.0|-30955.5|103393.46|||ANCOVA|||||103393.46|-30955.50|0.2850
74043201|NCT00871572|147638122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.584|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.584
74043202|NCT00871572|147638122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.426|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||||0.3|-0.7|0.426
74043203|NCT00871572|147638122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.657|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||||0.4|-0.6|0.657
74043204|NCT00871572|147638123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.365|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.365
74094712|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.33|TWO_SIDED|95.0|-0.21|0.64|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.64|-0.21|0.330
74094713|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|||<|0.001|TWO_SIDED|95.0|0.91|2.11|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.11|0.91|<0.001
74094714|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.81|||<|0.001|TWO_SIDED|95.0|1.21|2.42|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.42|1.21|<0.001
74043205|NCT00871572|147638123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.191|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.191
74043206|NCT00871572|147638123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.297|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.297
74043207|NCT00871572|147638124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.523|TWO_SIDED|95.0|-0.8|0.4|||ANCOVA|||||0.4|-0.8|0.523
74043208|NCT00871572|147638124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.476|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||||0.3|-0.7|0.476
74043209|NCT00871572|147638124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.634|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.634
74043210|NCT00871572|147638125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.919
74043211|NCT00871572|147638125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.864|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.864
74043212|NCT00871572|147638125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.726|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.726
74043213|NCT00735670|147638128|SUPERIORITY_OR_OTHER|||||||0.445|||||||Fisher Exact|||||||0.445
74013987|NCT04649255|147578669|OTHER||Exact binomial|96.4|||<|0.025|TWO_SIDED|95.0|96.4|100.0|||One-sided exact binomial test|Exact binomial one-sided lower 97.5% CI for performance goal test \>72% for primary effectiveness and \>82% for primary safety.||Descriptive assessment; H0: Ps ≤ PGS, versus HA: PS \> PGS, where where Ps is the population primary safety success rate in the Test group and PGS is the safety performance goal of 82%.||100|96.4|<0.025
74013988|NCT04649255|147578670|OTHER||Exact binomial|89.1|||<|0.025|TWO_SIDED|95.0|89.1|97.5|||One-sided exact binomial test|Exact binomial one-sided lower 97.5% CI for performance goal test \>72% for primary effectiveness and \>82% for primary safety.||Descriptive assessment; H0: PE ≤ PGE, versus HA: PE \> PGE, where PE is the proportion of target lesions with clinical success and PGE is the effectiveness performance goal of 72%.||97.5|89.1|<0.025
74013989|NCT04129528|147578672|SUPERIORITY||Ratio of geometric means CFZ533/placebo|1.173||||0.1817|TWO_SIDED|80.0|0.94|1.47||one-sided P-value|Mixed model repeated measure analysis|||||1.47|0.94|0.1817
74043214|NCT00735670|147638129|SUPERIORITY_OR_OTHER||REML|-0.31||||0.725|TWO_SIDED|95.0|-0.48|-0.15||Comparison of venlafaxine vs. placebo on change of PHQ-9 over time controlling for baseline PHQ-9 score.|Mixed Models Analysis|||A linear mixed model (LMM) analysis was used and included a random intercept effect based on lowest Akaike's Information Criterion values when we compared three random coefficient models (intercept, slope and intercept and slope). To examine whether allocation group influenced the effect of time and baseline PHQ-9 sore on the trajectory of PHQ-9 scores, we included two interaction terms (time by allocation group and baseline PHQ-9 score by allocation group).||-0.15|-0.48|0.725
74043215|NCT00187889|147638134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.6|STANDARD_ERROR_OF_MEAN|6.7||0.15|TWO_SIDED|95.0|-22.8|3.6||The P-value applies to this comparison, without adjustment, to the completers of the trial.|Satterthwaite corrected t-test||An expanded definition of the outcome measure is the difference between the percentage change (week 16) and the percentage change week 0). This is a calculation based on 4 measurements.|The null hypothesis is that the treatments are equivalent with respect to the primary outcome. The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups.||3.6|-22.8|0.15
74043216|NCT00187889|147638134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.39||0.92|TWO_SIDED|95.0|-0.79|0.72|||Satterthwaite corrected t-test||The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups. This is a different outcome variable than the primary.|The null hypothesis is that treatments are equivalent on this outcome. The study was powered around the primary outcome. No adjustment for multiple comparisons was planned.||0.72|-0.79|0.92
73880064|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.35||||0.2144|TWO_SIDED|95.0|0.61|9.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.07|0.61|0.2144
74013990|NCT01964352|147578678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.293|0.369|||Mixed Effects Model for Repeated Measure|||||0.369|0.293|<0.0001
74013991|NCT01964352|147578678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.075|0.148|||Mixed Effects Model for Repeated Measure|||||0.148|0.075|<0.0001
74013992|NCT01964352|147578678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.262|0.337|||Mixed Effects Model for Repeated Measure|||||0.337|0.262|<0.0001
74013993|NCT01964352|147578678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.044|0.116|||Mixed Effects Model for Repeated Measure|||||0.116|0.044|<0.0001
74013994|NCT01964352|147578678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.181|0.258|||Mixed Effects Model for Repeated Measure|||||0.258|0.181|<0.0001
74013995|NCT01964352|147578678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.018||0.0872|TWO_SIDED|95.0|-0.005|0.067|||Mixed Effects Model for Repeated Measure|||||0.067|-0.005|0.0872
74013996|NCT01964352|147578679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0124|0.2|||Mixed Effects Model for Repeated Measure|||||0.200|0.0124|<0.0001
74043217|NCT00108953|147638238|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.6||||0.016||95.0|0.33|0.95|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups.||0.95|0.33|0.016
74043218|NCT00108953|147638239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.007||95.0|0.37|0.74|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||0.74|0.37|0.007
74043219|NCT00108953|147638240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.018||95.0|0.45|0.83|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||0.83|0.45|0.018
74043220|NCT00108953|147638242|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.038||95.0|0.4|1.05|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||1.05|0.40|0.038
74043221|NCT01854593|147638248|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
74043222|NCT01854593|147638249|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||||||0.006
74043223|NCT01854593|147638250|SUPERIORITY_OR_OTHER|||||||0.033|||||||Fisher Exact|||||||0.033
73880065|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4321|TWO_SIDED|95.0|0.44|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.96|0.44|0.4321
74013997|NCT01964352|147578679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.019||0.1381|TWO_SIDED|95.0|-0.009|0.066|||Mixed Effects Model for Repeated Measure|||||0.066|-0.009|0.1381
74013998|NCT01964352|147578679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.113|0.188|||Mixed Effects Model for Repeated Measure|||||0.188|0.113|<0.0001
74013999|NCT01964352|147578679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.019||0.3872|TWO_SIDED|95.0|-0.021|0.054|||Mixed Effects Model for Repeated Measure|||||0.054|-0.021|0.3872
74043224|NCT01854593|147638251|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74043225|NCT01854593|147638252|SUPERIORITY_OR_OTHER|||||||0.667|||||||Wilcoxon (Mann-Whitney)|||||||0.667
74043226|NCT01854593|147638253|SUPERIORITY_OR_OTHER|||||||0.593|||||||Fisher Exact|||||||0.593
74043227|NCT01854593|147638254|SUPERIORITY_OR_OTHER|||||||0.298|||||||Wilcoxon (Mann-Whitney)|||||||0.298
74043228|NCT01854593|147638255|SUPERIORITY_OR_OTHER|||||||0.929|||||||Wilcoxon (Mann-Whitney)|||||||0.929
74043229|NCT01854593|147638256|SUPERIORITY_OR_OTHER|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||||||0.445
74043230|NCT01854593|147638257|SUPERIORITY_OR_OTHER|||||||0.131|||||||Chi-squared|||||||0.131
74043231|NCT01854593|147638258|SUPERIORITY_OR_OTHER|||||||0.149|||||||Fisher Exact|||||||0.149
74043232|NCT01854593|147638259|SUPERIORITY_OR_OTHER|||||||0.67|||||||Fisher Exact|||||||0.670
74014000|NCT01964352|147578679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.096|0.172|||Mixed Effects Model for Repeated Measure|||||0.172|0.096|<0.0001
74014001|NCT01964352|147578679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.019||0.5333|TWO_SIDED|95.0|-0.025|0.049|||Mixed Effects Model for Repeated Measure|||||0.049|-0.025|0.5333
74014002|NCT01964352|147578680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.894|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|95.0|-6.904|-2.884|||Mixed Effects Model for Repeated Measure|||||-2.884|-6.904|<0.0001
74014003|NCT01964352|147578680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.493|STANDARD_ERROR_OF_MEAN|1.009||0.0136|TWO_SIDED|95.0|-4.473|-0.513|||Mixed Effects Model for Repeated Measure|||||-0.513|-4.473|0.0136
74014004|NCT01964352|147578680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.122|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|-6.129|-2.114|||Mixed Effects Model for Repeated Measure|||||-2.114|-6.129|<0.0001
74014005|NCT01964352|147578680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.721|STANDARD_ERROR_OF_MEAN|1.008||0.088|TWO_SIDED|95.0|-3.698|0.256|||Mixed Effects Model for Repeated Measure|||||0.256|-3.698|0.0880
74014006|NCT01964352|147578680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.401|STANDARD_ERROR_OF_MEAN|1.029||0.0198|TWO_SIDED|95.0|-4.419|-0.382|||Mixed Effects Model for Repeated Measure|||||-0.382|-4.419|0.0198
74014007|NCT01964352|147578680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.772|STANDARD_ERROR_OF_MEAN|1.003||0.4415|TWO_SIDED|95.0|-2.741|1.196|||Mixed Effects Model for Repeated Measure|||||1.196|-2.741|0.4415
74014008|NCT01964352|147578681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.157|0.282|||Mixed Effects Model for Repeated Measure|||||0.282|0.157|<0.0001
74014009|NCT01964352|147578681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.032||0.5052|TWO_SIDED|95.0|-0.041|0.084|||Mixed Effects Model for Repeated Measure|||||0.084|-0.041|0.5052
74014010|NCT01964352|147578681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.146|0.271|||Mixed Effects Model for Repeated Measure|||||0.271|0.146|<0.0001
74014011|NCT01964352|147578681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.032||0.7566|TWO_SIDED|95.0|-0.052|0.072|||Mixed Effects Model for Repeated Measure|||||0.072|-0.052|0.7566
74043233|NCT01854593|147638260|SUPERIORITY_OR_OTHER|||||||0.378|||||||Chi-squared|||||||0.378
74043234|NCT01125293|147638318|OTHER|||||||0.69|||||||Two stage design, exact method|||In a two-stage Simon design, a VGPR or better rate of at least 18% is considered promising versus a 5% or less rate. In stage 1, if 1 or fewer of 23 evaluable participants achieve VGPR, the regimen is considered non-promising else continue with 24 more patients enrolled. If \</=4 of 47 evaluable patients have VGPR or better, the regimen is considered non-promising. If \>/=5, then the regimen is considered promising for further study. With this design, there is 90% power and 1-sided 10% alpha.|The study did not continue to stage 2 given 1 VGPR or better response was observed in 23 evaluable participants in stage 1.|||0.69
74043235|NCT01367860|147638327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|1.06||0.05|TWO_SIDED|95.0|-4.05|0.26|||t-test, 2 sided|||||0.26|-4.05|0.05
74043236|NCT01367860|147638328|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
74043237|NCT01367860|147638329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.9|<|0.05|TWO_SIDED|95.0|-2.21|1.43|||t-test, 2 sided|||||1.43|-2.21|<0.05
74043238|NCT01367860|147638330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.01|<|0.05|TWO_SIDED|95.0|-2.76|1.33|||t-test, 2 sided|||||1.33|-2.76|<0.05
74043239|NCT01367860|147638332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.13|<|0.05|TWO_SIDED|95.0|-2.58|2.01|||t-test, 2 sided|||||2.01|-2.58|<0.05
74043240|NCT01367860|147638333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|1.14|<|0.05|TWO_SIDED|95.0|-1.3|3.3|||t-test, 2 sided|||||3.3|-1.3|<0.05
74043241|NCT01367860|147638334|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|2.77|<|0.05|TWO_SIDED|95.0|-2.36|8.8|||t-test, 2 sided|||||8.8|-2.36|<0.05
74043242|NCT01367860|147638335|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|3.3|<|0.05|TWO_SIDED|95.0|-4.4|8.9|||t-test, 2 sided|||||8.9|-4.4|<0.05
74014012|NCT01964352|147578681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.136|0.261|||Mixed Effects Model for Repeated Measure|||||0.261|0.136|<0.0001
74014013|NCT01964352|147578681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.032||0.7199|TWO_SIDED|95.0|-0.051|0.073|||Mixed Effects Model for Repeated Measure|||||0.073|-0.051|0.7199
74014014|NCT01964352|147578682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.052|STANDARD_ERROR_OF_MEAN|0.273|<|0.0001|TWO_SIDED|95.0|1.516|2.588|||Mixed Effects Model for Repeated Measure|||||2.588|1.516|<0.0001
74014015|NCT01964352|147578682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.607|STANDARD_ERROR_OF_MEAN|0.27||0.0246|TWO_SIDED|95.0|0.078|1.137|||Mixed Effects Model for Repeated Measure|||||1.137|0.078|0.0246
74014016|NCT01964352|147578682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.952|STANDARD_ERROR_OF_MEAN|0.272|<|0.0001|TWO_SIDED|95.0|1.417|2.487|||Mixed Effects Model for Repeated Measure|||||2.487|1.417|<0.0001
74014017|NCT01964352|147578682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.507|STANDARD_ERROR_OF_MEAN|0.269||0.0599|TWO_SIDED|95.0|-0.021|1.035|||Mixed Effects Model for Repeated Measure|||||1.035|-0.021|0.0599
74014018|NCT01964352|147578682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.445|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|0.907|1.983|||Mixed Effects Model for Repeated Measure|||||1.983|0.907|<0.0001
74014019|NCT01964352|147578682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.268||0.7081|TWO_SIDED|95.0|-0.425|0.626|||Mixed Effects Model for Repeated Measure|||||0.626|-0.425|0.7081
74094715|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.163|TWO_SIDED|95.0|-0.73|0.12|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.12|-0.73|0.163
74014020|NCT01964352|147578683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.457|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.39|0.524|||Mixed Effects Model for Repeated Measure|||||0.524|0.390|<0.0001
74014021|NCT01964352|147578683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.095|0.225|||Mixed Effects Model for Repeated Measure|||||0.225|0.095|<0.0001
74014022|NCT01964352|147578683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.398|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.331|0.465|||Mixed Effects Model for Repeated Measure|||||0.465|0.331|<0.0001
74014023|NCT01964352|147578683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.033||0.0023|TWO_SIDED|95.0|0.036|0.165|||Mixed Effects Model for Repeated Measure|||||0.165|0.036|0.0023
74094716|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.91|||<|0.001|TWO_SIDED|95.0|3.18|4.65|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.65|3.18|<0.001
74014024|NCT01964352|147578683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.229|0.365|||Mixed Effects Model for Repeated Measure|||||0.365|0.229|<0.0001
74014025|NCT01964352|147578683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.033||0.0701|TWO_SIDED|95.0|-0.005|0.123|||Mixed Effects Model for Repeated Measure|||||0.123|-0.005|0.0701
74014026|NCT01908101|147578684|OTHER|comparison analysis|Median Difference (Final Values)|3.5|||||TWO_SIDED|95.0|2.6|4.6||comparison analysis; no P value|||The estimated value is 3.5 months, not years.|Progression free survival (PFS). We hypothesize that metronomic dosing of eribulin will result in a PFS of 4-6 months.||4.6|2.6|
74014027|NCT00166205|147578685|SUPERIORITY_OR_OTHER||Percent of ITT subjects|69.6||||||95.0|63.8|74.9||||||A sample size of 215, the adverse event (AE) rate at three years could be estimated with precision as determined by the interval half-width of approximately ± 7%.||74.9|63.8|
74014028|NCT00166205|147578686|SUPERIORITY_OR_OTHER||Mean|75.7|STANDARD_DEVIATION|39.8||||95.0|70.5|80.8||||||||80.8|70.5|
74014029|NCT00166205|147578687|SUPERIORITY_OR_OTHER||Mean|35.7|STANDARD_DEVIATION|6.2||||95.0|34.9|36.5||||||||36.5|34.9|
74014030|NCT00166205|147578688|SUPERIORITY_OR_OTHER||Mean|51.3|STANDARD_DEVIATION|45.8||||95.0|47.6|54.9||||||||54.9|47.6|
74014031|NCT00166205|147578689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.4|STANDARD_DEVIATION|10.3||||95.0|9.2|11.7|||||Value at 36 months minus value at baseline. Positive values indicate improved Quality of Life (QOL)|||11.7|9.2|
74014032|NCT00166205|147578690|SUPERIORITY_OR_OTHER||Mean|5.7|STANDARD_DEVIATION|0.7||||95.0|5.6|5.8||||||||5.8|5.6|
74014033|NCT00166205|147578692|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||A one-sided paired t-test would have 80% power to reject the null hypothesis in favor of the alternative (i.e., that the SAGB system is not inferior to the clinically meaningful result of 36.2 for 224 subjects) assuming: a standard deviation (SD) of (21.6), an equivalent limit difference of (3.6), and a significance level of 0.05.||||<0.001
74014034|NCT00166205|147578693|SUPERIORITY_OR_OTHER||Mean|56.4|STANDARD_DEVIATION|14.7||||95.0|54.5|58.4||||||||58.4|54.5|
74014035|NCT00166205|147578694|SUPERIORITY_OR_OTHER||Mean|114.5|STANDARD_DEVIATION|32.3||||95.0|110.1|118.8||||||||118.8|110.1|
74014036|NCT00166205|147578695|SUPERIORITY_OR_OTHER||Mean|193.5|STANDARD_DEVIATION|36.9||||95.0|188.6|198.4||||||||198.4|188.6|
74014037|NCT03787472|147578696|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least-Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-5.5|6.6|||Linear Mixed Model|The Kenward and Roger method was used for the calculation of the denominator of degrees of freedom.|Mean difference was calculated as Test - Control|||6.6|-5.5|
74014038|NCT03787472|147578697|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.025|0.041|||Linear Mixed Model||Mean difference was calculated as Test - Control|Distance Standard High Contrast Bright||0.041|-0.025|
74014039|NCT03787472|147578697|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|-0.012|STANDARD_ERROR_OF_MEAN|0.0155|||TWO_SIDED|95.0|-0.043|0.019|||Linear Mixed Model||Mean difference was calculated as Test - Control|Intermediate Standard High Contrast Bright||0.019|-0.043|
74014040|NCT03787472|147578697|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0169|||TWO_SIDED|95.0|-0.03|0.037|||Linear Mixed Model||Mean difference was calculated as Test - Control|Near Standard High Contrast Bright||0.037|-0.030|
74014041|NCT00477165|147578698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.59|TWO_SIDED|95.0|0.687|1.196||p\<0.05 for statistical significance|t-test, 2 sided||Repeated-measures logistic regression model, assuming the citalopram effect builds linearly over time starting at week 3.|Null hypothesis: number of patients achieving adequate relief is the same in both Citalopram and Placebo groups||1.196|0.687|0.59
74014042|NCT00105443|147578706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6931||||0.00583||95.0|0.5549|0.8658||According to the pre-specified O'Brien-Fleming alpha spending function, the alpha value for this second interim analysis was 0.0073 (corresponding to a nominal value of 0.0077 after taking into account the first interim analysis).|Log Rank||This is the sorafenib to placebo hazard ratio.|"The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.02 stratified by region, ECOG PS and tumor burden. In addition to the final analysis at the end of the study, 2 formal interim analyses of overall survival were planned. An alpha spending function was used to ensure that the false positive rate is less than or equal to 0.02 (1-sided). The study was stopped at the second interim analysis, the results of which are reported here."||0.8658|0.5549|0.00583
74014043|NCT00105443|147578707|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0764||||0.7676||95.0|0.8837|1.311|||Log Rank||This is the sorafenib to placebo hazard ratio.|"The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.005 stratified by region, ECOG PS and tumor burden. This was a co-primary endpoint with overall survival. No alpha-spending adjustments were necessary as it was only to be analyzed at the end of study."||1.3110|0.8837|0.7676
74014044|NCT00105443|147578708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5764||||7e-06||95.0|0.4484|0.741|||Log Rank||This is the sorafenib to placebo hazard ratio.|"In the analysis of TTP, based on independent radiological review performed to review data up to 12 May 2006, the 2 treatment groups were compared using a 1-sided log rank test with an alpha of 0.025, stratified by region, ECOG PS, and tumor burden."||0.7410|0.4484|0.000007
74043243|NCT01367860|147638336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|3.6|<|0.05|TWO_SIDED|95.0|-7.15|7.55|||t-test, 2 sided|||||7.55|-7.15|<0.05
74043244|NCT01367860|147638337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|3.65|<|0.05|TWO_SIDED|95.0|-7.14|7.67|||t-test, 2 sided|||||7.67|-7.14|<0.05
74094717|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.001|TWO_SIDED|95.0|0.35|1.38|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.38|0.35|0.001
74014045|NCT00105443|147578709|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-11.95||||0.001641||95.0|-19.56|-4.35|||Cochran-Mantel-Haenszel||Sorafenib minus placebo difference|"Disease control rates were compared between treatment groups using the Cochran Mantel Haenszel (CMH) test with a 1-sided alpha of 0.025, adjusting for region, ECOG PS, and tumor burden."||-4.35|-19.56|0.001641
74014046|NCT01157078|147578730|SUPERIORITY_OR_OTHER||LS mean|-1.0|STANDARD_ERROR_OF_MEAN|1.08||0.349|TWO_SIDED|95.0|-3.14|1.11||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-3.14|0.349
74014047|NCT01157078|147578731|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.29||0.444|TWO_SIDED|95.0|0.75|1.92|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.92|0.75|0.444
74014048|NCT01157078|147578732|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52|STANDARD_ERROR_OF_MEAN|0.42||0.13|TWO_SIDED|95.0|0.88|2.61|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.61|0.88|0.130
74043245|NCT01367860|147638338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|3.18|<|0.05|TWO_SIDED|95.0|-8.16|4.76|||t-test, 2 sided|||||4.76|-8.16|<0.05
74043246|NCT01367860|147638339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|0.88|<|0.05|TWO_SIDED|95.0|-0.12|3.46|||t-test, 2 sided|||||3.46|-0.12|<0.05
74043247|NCT01367860|147638340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|1.09|<|0.05|TWO_SIDED|95.0|-2.0|2.4|||t-test, 2 sided|||||2.4|-2|<0.05
74043248|NCT01367860|147638341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|1.08|<|0.05|TWO_SIDED|95.0|-2.55|1.85|||t-test, 2 sided|||||1.85|-2.55|<0.05
74043249|NCT01367860|147638342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|1.11|<|0.05|TWO_SIDED|95.0|-2.29|2.23|||t-test, 2 sided|||||2.23|-2.29|<0.05
74043250|NCT01367860|147638343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.17|<|0.05|TWO_SIDED|95.0|-1.67|3.08|||t-test, 2 sided|||||3.08|-1.67|<0.05
74094718|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.003|TWO_SIDED|95.0|0.26|1.31|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.31|0.26|0.003
73880066|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.53||||0.1778|TWO_SIDED|95.0|0.66|9.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.75|0.66|0.1778
74014049|NCT01157078|147578733|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75|STANDARD_ERROR_OF_MEAN|0.96||0.307|TWO_SIDED|95.0|0.6|5.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||5.14|0.60|0.307
74043251|NCT01270958|147638344|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043252|NCT01270958|147638345|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043253|NCT01270958|147638346|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043254|NCT01270958|147638347|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043255|NCT01270958|147638348|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043256|NCT01270958|147638349|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043257|NCT01270958|147638350|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043258|NCT01270958|147638351|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043259|NCT01270958|147638352|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||<0.01
74043260|NCT01270958|147638353|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043261|NCT01270958|147638354|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043262|NCT01270958|147638355|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043263|NCT01270958|147638356|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043264|NCT01270958|147638357|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043265|NCT01270958|147638358|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043266|NCT01270958|147638359|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043267|NCT01270958|147638360|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043268|NCT01270958|147638361|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043269|NCT01270958|147638362|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
74043270|NCT02481596|147638365|SUPERIORITY|||||||0.045||||||Beta=.083. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.045
74043271|NCT02481596|147638365|SUPERIORITY|||||||0.006||||||Beta=.126. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.006
74043272|NCT02481596|147638366|SUPERIORITY|||||||0.518||||||Beta=.031. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.518
74043273|NCT02481596|147638366|SUPERIORITY|||||||0.092||||||Beta=.092. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.092
74043274|NCT02481596|147638367|SUPERIORITY|||||||0.53||||||Beta=-.027. Threshold p\<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations||||.53
74043275|NCT02481596|147638367|SUPERIORITY|||||||0.41||||||Beta=-.037. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.41
74043276|NCT02481596|147638368|SUPERIORITY|||||||0.024||||||Beta=.088. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.||||.024
74043277|NCT02481596|147638368|SUPERIORITY|||||||0.003||||||Beta=.128. Threshold p\<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.||||.003
74043278|NCT02481596|147638369|SUPERIORITY|||||||0.001||||||Beta=-.133. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.||||.001
74043279|NCT02481596|147638369|SUPERIORITY|||||||0.012||||||Beta=-.115. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.||||.012
74043280|NCT02481596|147638370|SUPERIORITY|||||||0.015||||||Beta=.114. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.015
74043281|NCT02481596|147638370|SUPERIORITY|||||||0.034||||||Beta=.101. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.034
74043282|NCT00631540|147638397|SUPERIORITY_OR_OTHER||Mean Patency Rate|91.7|||<|0.0001|TWO_SIDED|95.0|84.2|95.9|||Z-test, 1-sided||GEE model estimate.|Alternative hypothesis is 9-month primary patency rate greater than 60%.||95.9|84.2|<0.0001
74043283|NCT03136367|147638462|SUPERIORITY|||||||0.045||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.045
74043284|NCT03136367|147638462|SUPERIORITY|||||||0.2||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.20
74043285|NCT03136367|147638462|SUPERIORITY|||||||0.82||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.82
74043286|NCT03136367|147638463|SUPERIORITY|||||||0.048||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.048
74043287|NCT03136367|147638463|SUPERIORITY|||||||0.015||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.015
74094719|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.05|||<|0.001|TWO_SIDED|95.0|2.32|3.79|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.79|2.32|<0.001
74094720|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.13|||<|0.001|TWO_SIDED|95.0|2.39|3.87|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.87|2.39|<0.001
74094721|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.769|TWO_SIDED|95.0|-0.6|0.44|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.44|-0.60|0.769
74094722|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|4.65|||<|0.001|TWO_SIDED|95.0|3.88|5.42|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.42|3.88|<0.001
74094723|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.002|TWO_SIDED|95.0|0.32|1.4|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.40|0.32|0.002
74094724|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|||<|0.001|TWO_SIDED|95.0|0.83|1.93|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.93|0.83|<0.001
74094725|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.79|||<|0.001|TWO_SIDED|95.0|3.02|4.56|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.56|3.02|<0.001
73880067|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8016|TWO_SIDED|95.0|0.28|5.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.20|0.28|0.8016
74043288|NCT03136367|147638463|SUPERIORITY|||||||0.43||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.43
74094726|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.27|||<|0.001|TWO_SIDED|95.0|2.49|4.04|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.04|2.49|<0.001
74043289|NCT03136367|147638464|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.46
74043290|NCT03136367|147638464|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.34
74043291|NCT03136367|147638464|SUPERIORITY|||||||0.165|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.165
74043292|NCT03136367|147638466|SUPERIORITY|||||||0.25||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.25
74043293|NCT03136367|147638466|SUPERIORITY|||||||0.89||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.89
74043294|NCT03136367|147638466|SUPERIORITY|||||||0.54||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.54
74043295|NCT03136367|147638467|SUPERIORITY|||||||0.72||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.72
74043296|NCT03136367|147638467|SUPERIORITY|||||||0.41||||||Adjusted for repeated within-patient measurements.|McNemar|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.41
74043297|NCT03136367|147638467|SUPERIORITY|||||||0.28||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.28
74043298|NCT03136367|147638468|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.01
74014050|NCT01157078|147578734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.52||0.313|TWO_SIDED|95.0|0.71|2.94|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.94|0.71|0.313
74014051|NCT01157078|147578735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77|STANDARD_ERROR_OF_MEAN|0.79||0.201|TWO_SIDED|95.0|0.74|4.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||4.24|0.74|0.201
74014052|NCT01157078|147578736|SUPERIORITY_OR_OTHER||LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.82||0.552|TWO_SIDED|95.0|-2.1|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.12|-2.10|0.552
74014053|NCT01157078|147578737|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.803||95.0|-0.31|0.24|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.24|-0.31|0.803
74043299|NCT03136367|147638468|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.12
74043300|NCT03136367|147638468|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.78
74043301|NCT03136367|147638469|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||<0.01
74043302|NCT03136367|147638469|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||<0.01
74094727|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.062|TWO_SIDED|95.0|-0.03|1.06|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.06|-0.03|0.062
74014054|NCT01157078|147578738|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.28||0.44|TWO_SIDED|95.0|0.75|1.91|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.91|0.75|0.440
74014055|NCT01157078|147578739|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.55||0.768|TWO_SIDED|95.0|-0.91|1.23||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.23|-0.91|0.768
74014056|NCT01157078|147578740|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.78||0.373|TWO_SIDED|95.0|-0.84|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.24|-0.84|0.373
74043303|NCT03136367|147638470|SUPERIORITY|||||||0.06||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.06
74043304|NCT03136367|147638470|SUPERIORITY|||||||0.65||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.65
74043305|NCT03136367|147638470|SUPERIORITY|||||||0.36||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.36
74043306|NCT03136367|147638471|SUPERIORITY|||||||0.11||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.11
74043307|NCT03136367|147638471|SUPERIORITY|||||||0.037||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.037
74043308|NCT03136367|147638471|SUPERIORITY|||||||0.28||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.28
74043309|NCT00771173|147638473|SUPERIORITY_OR_OTHER|||||||0.745|TWO_SIDED||||||t-test, 2 sided|||The independent samples t-test was used to test the null hypothesis that the mean VAS score for the active treatment cohort (i.e., those receiving pyridium) was no different than the mean VAS score for those receiving placebo.||||.745
74043310|NCT01602549|147638477|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.965|||||TWO_SIDED|95.0|0.831|1.12|||||Day 1: The adjusted means (AMs) and ratios were estimated using a mixed model (MM) fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 1||1.120|0.831|
74043311|NCT01602549|147638477|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.886|||||TWO_SIDED|95.0|0.763|1.029|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 8||1.029|0.763|
74043312|NCT01602549|147638477|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.937|||||TWO_SIDED|95.0|0.85|1.033|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8: Day 1||1.033|0.850|
74014057|NCT01157078|147578741|SUPERIORITY_OR_OTHER||LS mean|-0.7|STANDARD_ERROR_OF_MEAN|0.9||0.435|TWO_SIDED|95.0|-2.47|1.07|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.07|-2.47|0.435
74014058|NCT01157078|147578742|SUPERIORITY_OR_OTHER||LS mean|-0.7|STANDARD_ERROR_OF_MEAN|0.97||0.501|TWO_SIDED|95.0|-2.56|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||1.25|-2.56|0.501
74014059|NCT01157078|147578743|SUPERIORITY_OR_OTHER||LS mean|-0.62|STANDARD_ERROR_OF_MEAN|0.771||0.424|TWO_SIDED|95.0|-2.134|0.901||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.901|-2.134|0.424
74014060|NCT01157078|147578744|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.214|TWO_SIDED|95.0|-0.96|0.22||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.22|-0.96|0.214
73888022|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.2||||0.1415|TWO_SIDED|95.0|-154.6|22.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.3|-154.6|0.1415
74014061|NCT01157078|147578745|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.931|TWO_SIDED|95.0|-0.59|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.54|-0.59|0.931
74043313|NCT01602549|147638477|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.02|||||TWO_SIDED|95.0|0.89|1.17|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8:Day 1 Placebo||1.170|0.890|
74043314|NCT01602549|147638479|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.864|||||TWO_SIDED|95.0|0.702|1.064|||||Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1||1.064|0.702|
74043315|NCT01602549|147638479|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.018|||||TWO_SIDED|95.0|0.824|1.257|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8||1.257|0.824|
74043316|NCT01602549|147638479|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.018|||||TWO_SIDED|95.0|0.889|1.166|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 VS Day 1 GSK962040 50 mg||1.166|0.889|
74043317|NCT01602549|147638479|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.865|||||TWO_SIDED|95.0|0.709|1.055|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 Vs Day 1 Placebo||1.055|0.709|
74043318|NCT01602549|147638480|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||Wilcoxon rank-sum test|||Day 1||||0.157
74043319|NCT01602549|147638480|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Wilcoxon rank-sum test|||Day 8||||0.186
74043320|NCT01602549|147638482|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.239|||||TWO_SIDED|95.0|-16.015|7.537|||||Day 1: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1||7.537|-16.015|
74043321|NCT01602549|147638482|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.327|||||TWO_SIDED|95.0|-17.567|6.914|||||Day 8: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8||6.914|-17.567|
74043322|NCT01602549|147638483|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.16||||||95.0|-3.9|-0.41|||||Day 1; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 1||-0.41|-3.90|
74043323|NCT01602549|147638483|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.63|||||TWO_SIDED|95.0|-5.41|-1.85|||||Day 8; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 8||-1.85|-5.41|
74043324|NCT01602549|147638483|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.29|||||TWO_SIDED|95.0|-4.65|0.07|||||Day 1; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 1||0.07|-4.65|
74014062|NCT01157078|147578746|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.755|TWO_SIDED|95.0|-0.6|0.44|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.44|-0.60|0.755
74014063|NCT01157078|147578747|SUPERIORITY_OR_OTHER||LS mean|0.82|STANDARD_ERROR_OF_MEAN|1.789||0.646|TWO_SIDED|95.0|-2.699|4.346|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||4.346|-2.699|0.646
74014064|NCT01157078|147578748|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.446|TWO_SIDED|95.0|-0.31|0.14|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.14|-0.31|0.446
74043325|NCT01602549|147638483|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.46|||||TWO_SIDED|95.0|-4.85|-0.07|||||Day 8; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 8||-0.07|-4.85|
74094728|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|4.83|||<|0.001|TWO_SIDED|95.0|4.01|5.64|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.64|4.01|<0.001
74094729|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76||||0.009|TWO_SIDED|95.0|0.19|1.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.33|0.19|0.009
74043326|NCT01602549|147638483|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.38|||||TWO_SIDED|95.0|-10.28|-0.49|||||Day 8; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III -GSK962040 50 mg Vs Placebo Day 8||-0.49|-10.28|
74043327|NCT01602549|147638483|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.56|||||TWO_SIDED|95.0|-1.65|0.54|||||Day 1; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 1||0.54|-1.65|
74043328|NCT01602549|147638483|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.9|||||TWO_SIDED|95.0|-2.02|0.22|||||Day 8; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 8||0.22|-2.02|
74043329|NCT01602549|147638483|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.69|||||TWO_SIDED|95.0|-13.77|0.39|||||Day 1; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 1||0.39|-13.77|
74043330|NCT01602549|147638483|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-12.5|||||TWO_SIDED|95.0|-19.67|-5.29|||||Day 8; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 8||-5.29|-19.67|
74043331|NCT01602549|147638483|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-1.7|||||TWO_SIDED|95.0|-6.53|3.13|||||Day 1; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III- GSK962040 50 mg Vs Placebo Day 1||3.13|-6.53|
74043332|NCT01602549|147638484|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.14|||||TWO_SIDED|95.0|-9.07|2.78|||||Day 1; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 1||2.78|-9.07|
74043333|NCT01602549|147638484|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.18|||||TWO_SIDED|95.0|-9.11|2.75|||||Day 1; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1||2.75|-9.11|
74043334|NCT01602549|147638484|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.66|||||TWO_SIDED|95.0|-9.59|2.27|||||Day 1; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1:||2.27|-9.59|
74043335|NCT01602549|147638484|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.15|||||TWO_SIDED|95.0|-10.07|1.76|||||Day 1; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1||1.76|-10.07|
74043336|NCT01602549|147638484|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.8|||||TWO_SIDED|95.0|-12.79|-0.81|||||Day 8; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 8||-0.81|-12.79|
74043337|NCT01602549|147638484|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.97|||||TWO_SIDED|95.0|-9.96|2.03|||||Day 8; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8||2.03|-9.96|
74014065|NCT01157078|147578749|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.178|TWO_SIDED|95.0|-0.06|0.33|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.33|-0.06|0.178
74043338|NCT01602549|147638484|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.29|||||TWO_SIDED|95.0|-11.29|0.71|||||Day 8; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8||0.71|-11.29|
74014066|NCT01157078|147578750|SUPERIORITY_OR_OTHER||LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.61||0.515|TWO_SIDED|95.0|-4.22|2.12|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.12|-4.22|0.515
74014067|NCT01157078|147578751|SUPERIORITY_OR_OTHER||LS mean|0.024|STANDARD_ERROR_OF_MEAN|0.0226||0.298|TWO_SIDED|95.0|-0.0209|0.068||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0680|-0.0209|0.298
74014068|NCT01157078|147578751|SUPERIORITY_OR_OTHER||LS mean|1.6|STANDARD_ERROR_OF_MEAN|2.34||0.484|TWO_SIDED|95.0|-2.98|6.26||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||6.26|-2.98|0.484
74014069|NCT03187769|147578776|SUPERIORITY||Least Squares Mean Difference|-1.87||||0.012|TWO_SIDED|95.0|-3.33|-0.41|||ANCOVA|||||-.41|-3.33|.012
74014070|NCT00879229|147578798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.0|STANDARD_ERROR_OF_MEAN|67.0||0.696|TWO_SIDED|95.0|-54.0|17.0||This is an exact Wilcoxon rank sum test p-value for testing equality of ambrisentan and placebo distributions.|Wilcoxon (Mann-Whitney)|||||17|-54|0.696
74014071|NCT01097746|147578809|SUPERIORITY||Hazard Ratio (HR)|1.71||||0.33|TWO_SIDED|95.0|0.58|4.98|||t-test, 2 sided|||Participants for optimal ≤ 1 cm||4.98|0.58|0.33
74014072|NCT01097746|147578809|SUPERIORITY||Hazard Ratio (HR)|3.75||||0.04|TWO_SIDED|95.0|1.05|13.34|||t-test, 2 sided|||suboptimal \> 1 cm||13.34|1.05|0.04
74014073|NCT00631371|147578830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.8|TWO_SIDED|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and Memorial Sloan Kettering Cancer Center \[MSKCC\] risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95 percent (%) confidence interval (CI) from the stratified cox proportional hazard model were also presented.||1.3|0.9|0.8
74014074|NCT00631371|147578831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.9|TWO_SIDED|95.0|1.0|1.4|||Log Rank|||P-value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and MSKCC risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.4|1.0|0.9
74014075|NCT00631371|147578832|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.8|1.3|||Cochran-Mantel-Haenszel|||P-value (2-sided), risk ratio and associated 95% CI were based on Cochran-Mantel-Haenszel test stratified by prior nephrectomy and MSKCC risk group as randomized.||1.3|0.8|1.0
74014076|NCT00631371|147578833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.6|TWO_SIDED|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and MSKCC risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.3|0.9|0.6
74043339|NCT01602549|147638484|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-8.9|||||TWO_SIDED|95.0|-14.88|-2.91|||||Day 8; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8||-2.91|-14.88|
74014077|NCT00623480|147578835|SUPERIORITY_OR_OTHER||Ratio (On-Demand vs. Prophylaxis)|14.7|||<|0.0001|TWO_SIDED|95.0|8.1|26.5|||Negative Binomial Regression Model|Adjusted for time of follow-up||||26.5|8.1|<0.0001
74014078|NCT00623480|147578836|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|-0.17||||0.6614|TWO_SIDED|95.0|-0.92|0.59|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||0.59|-0.92|0.6614
74014079|NCT00623480|147578837|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|-0.94||||0.0072|TWO_SIDED|95.0|-1.61|-0.26|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||-0.26|-1.61|0.0072
74014080|NCT00623480|147578838|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|13.15|||||TWO_SIDED|95.0|5.23|21.08||no p-values computed|Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||21.08|5.23|
74014081|NCT00783094|147578874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.201|TWO_SIDED|95.0|-1.8|0.4|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo|||0.4|-1.8|0.201
74014082|NCT00783094|147578874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.062|TWO_SIDED|95.0|-2.2|0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.1|-2.2|0.062
74014083|NCT00783094|147578875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.356|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.2|-0.7|0.356
74014084|NCT00783094|147578875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.487|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.3|-0.6|0.487
74014085|NCT00783094|147578876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.228|TWO_SIDED|95.0|-1.3|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo|||0.3|-1.3|0.228
74014086|NCT00783094|147578876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.033|TWO_SIDED|95.0|-1.7|-0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||-0.1|-1.7|0.033
74014087|NCT00783094|147578877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.249|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.1|-0.4|0.249
74014088|NCT00783094|147578877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||-0.0|-0.6|0.022
74014089|NCT00783094|147578878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.904|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|with effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.3|-0.4|0.904
74014090|NCT00783094|147578878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.8|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|With effects for treatment, BPH severity(moderate/severe), prior alpha blocker use (yes/no), and baseline value.||||0.3|-0.4|0.800
74043340|NCT01602549|147638485|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.31|||||TWO_SIDED|95.0|-3.71|-0.9|||||OFF: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|OFF: Treatment Period||-0.90|-3.71|
74043341|NCT01602549|147638485|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|1.88|||||TWO_SIDED|95.0|0.28|3.48|||||ON: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|ON: Treatment Period||3.48|0.28|
74043342|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.83|||||TWO_SIDED|95.0|-21.79|16.13|||||Day 1, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: Day GSK962040 50 mg Vs Placebo Day 1||16.13|-21.79|
74043343|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.58|||||TWO_SIDED|95.0|-18.39|19.56|||||Day 1, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 1||19.56|-18.39|
74014091|NCT00783094|147578879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.147|TWO_SIDED|95.0|-1.5|0.2|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.2|-1.5|0.147
74014092|NCT00783094|147578879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.094|TWO_SIDED|95.0|-1.6|0.1|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.1|-1.6|0.094
74014093|NCT00783094|147578882|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-Value for systolic blood pressure.|Wilcoxin rank-sum test|||||||0.342
74014094|NCT00783094|147578882|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-Value for systolic blood pressure.|Wilcoxin rank sum test|||||||0.127
74014095|NCT00783094|147578882|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test|||||||0.705
74043344|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|1.84|||||TWO_SIDED|95.0|-17.18|20.86|||||Day 1, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Day 1, 30 min PD||20.86|-17.18|
74043345|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.28|||||TWO_SIDED|95.0|-18.72|19.28|||||Day 1, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 1||19.28|-18.72|
74043346|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.38|||||TWO_SIDED|95.0|-22.35|15.58|||||Day 1, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 1||15.58|-22.35|
74014096|NCT00783094|147578882|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test|||||||0.173
74014097|NCT00783094|147578883|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||Wilcoxin rank-sum test|||||||0.606
74014098|NCT00783094|147578883|SUPERIORITY_OR_OTHER|||||||0.149||95.0|||||Wilcoxin rank-sum test|||||||0.149
74014099|NCT00783094|147578884|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxin rank-sum test|||||||0.428
74014100|NCT00783094|147578884|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||Wilcoxin rank-sum test|||||||0.426
74014101|NCT00783094|147578885|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxin rank-sum|||||||0.060
74014102|NCT00783094|147578885|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Wilcoxin rank-sum|||||||0.212
74014103|NCT04852848|147578907|EQUIVALENCE|In our original power calculation, we expected to randomly assign 200 individuals to the Connect2Test (n = 100) and control conditions (n = 100). Power calculations were conducted using G\*Power assuming a two-tailed test with alpha = .05, power = .80, and an estimated COVID-19 testing rate in the Connect2Test condition of 20%. With these assumptions, the minimum detectable effect size (odds ratio) is 2.46, which corresponds to a moderate Cohen's d (0.49).|Odds Ratio (OR)|1.18||||0.6298|TWO_SIDED|95.0|0.61|2.27|||Chi-squared||The control condition was the reference category (Connect2Test intervention = 1, Control = 0).|||2.27|0.61|.6298
74014104|NCT00517595|147578912|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).||||0.02
74014105|NCT00517595|147578913|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).||||0.0041
74014106|NCT05525533|147578950|SUPERIORITY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-1.87|2.24|||Regression, Linear|||||2.24|-1.87|
74014107|NCT05525533|147578950|SUPERIORITY||Mean Difference (Final Values)|1.55|||||TWO_SIDED|95.0|-0.73|3.82|||Regression, Linear|||||3.82|-0.73|
74014108|NCT05525533|147578952|SUPERIORITY||Mean Difference (Final Values)|7.58|||||TWO_SIDED|95.0|-2.92|18.0|||Regression, Linear|||||18|-2.92|
74014109|NCT05525533|147578952|SUPERIORITY||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|0.64|31.0|||Regression, Linear|||||31|0.64|
74043347|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.18|||||TWO_SIDED|95.0|-23.13|14.76|||||Day 1, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1||14.76|-23.13|
74043348|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.39|||||TWO_SIDED|95.0|-25.36|12.58|||||Day 1, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1||12.58|-25.36|
74043349|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.77|||||TWO_SIDED|95.0|-18.2|19.75|||||Day 1, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1||19.75|-18.20|
74043350|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.51|||||TWO_SIDED|95.0|-18.51|19.52|||||Day 8, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: GSK962040 50 mg Vs Placebo Day 8||19.52|-18.51|
74014110|NCT05525533|147578954|SUPERIORITY||Mean Difference (Final Values)|47.0|||||TWO_SIDED|95.0|-18.0|113.0|||Regression, Linear|||||113|-18|
74043351|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|3.32|||||TWO_SIDED|95.0|-15.7|22.33|||||Day 8, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 8||22.33|-15.70|
74014111|NCT05525533|147578954|SUPERIORITY||Mean Difference (Final Values)|113.0|||||TWO_SIDED|95.0|38.0|189.0|||Regression, Linear|||||189|38|
74014112|NCT05525533|147578955|SUPERIORITY||Mean Difference (Final Values)|3.63|||||TWO_SIDED|95.0|-1.37|8.63|||Regression, Linear|||||8.63|-1.37|
74014113|NCT05525533|147578955|SUPERIORITY||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-1.5|4.5|||Regression, Linear|||||4.50|-1.50|
74014114|NCT05525533|147578956|SUPERIORITY||Mean Difference (Final Values)|1.32|||||TWO_SIDED|95.0|-0.36|7.3|||Regression, Linear|||||7.30|-0.36|
74014115|NCT05525533|147578956|SUPERIORITY||Mean Difference (Final Values)|3.38|||||TWO_SIDED|95.0|-0.54|7.3|||Regression, Linear|||||7.30|-0.54|
74014116|NCT05525533|147578957|SUPERIORITY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-3.38|3.72|||Regression, Linear|||||3.72|-3.38|
74043352|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.94|||||TWO_SIDED|95.0|-21.97|16.08|||||Day 8, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|30 min PD: GSK962040 50 mg Vs Placebo Day 8||16.08|-21.97|
74014117|NCT05525533|147578957|SUPERIORITY||Mean Difference (Final Values)|7.57|||||TWO_SIDED|95.0|0.42|15.0|||Regression, Linear|||||15|0.42|
74014118|NCT05525533|147578958|SUPERIORITY||Mean Difference (Final Values)|2.46|||||TWO_SIDED|95.0|-0.11|5.02|||Regression, Linear|||||5.02|-0.11|
74014119|NCT05525533|147578958|SUPERIORITY||Mean Difference (Final Values)|3.29|||||TWO_SIDED|95.0|0.33|6.25|||Regression, Linear|||||6.25|0.33|
74014120|NCT03703102|147578961|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
74014121|NCT03703102|147578961|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
74014122|NCT03703102|147578961|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
74014123|NCT03703102|147578961|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
74014124|NCT00876187|147578985|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.21||0.113|TWO_SIDED|95.0|-0.74|0.08|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) was based on least squares (LS) mean. Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.08|-0.74|0.113
74014125|NCT00876187|147578985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.19|-0.42|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.42|-1.19|<0.001
74014126|NCT00876187|147578985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.31|-0.54|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.54|-1.31|<0.001
74014127|NCT00876187|147578985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.2||0.688|TWO_SIDED|95.0|-0.31|0.47|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.47|-0.31|0.688
74014128|NCT00876187|147578985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.76|-0.03|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.03|-0.76|0.035
74014129|NCT00876187|147578985|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.19||0.006|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-0.88|0.006
74014130|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.18||0.221|TWO_SIDED|95.0|-0.57|0.13|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.13|-0.57|0.221
74014131|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-0.90|<0.001
74014132|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.027|TWO_SIDED|95.0|-0.7|-0.04|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.04|-0.70|0.027
74014133|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.17||0.082|TWO_SIDED|95.0|-0.04|0.62|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.62|-0.04|0.082
74014134|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.703|TWO_SIDED|95.0|-0.37|0.25|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.25|-0.37|0.703
74014135|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.16||0.379|TWO_SIDED|95.0|-0.17|0.45|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.45|-0.17|0.379
74014136|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.19||0.012|TWO_SIDED|95.0|-0.87|-0.11|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.11|-0.87|0.012
74014137|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.39|-0.67|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.67|-1.39|<0.001
74014138|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.31|-0.58|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.31|<0.001
74014139|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.862|TWO_SIDED|95.0|-0.33|0.39|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.39|-0.33|0.862
74014140|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.85|-0.17|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.85|0.003
74014141|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.014|TWO_SIDED|95.0|-0.76|-0.09|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.09|-0.76|0.014
74014142|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.2||0.019|TWO_SIDED|95.0|-0.86|-0.08|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-0.86|0.019
74014143|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.25|-0.51|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.51|-1.25|<0.001
74014144|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.56|-1.29|<0.001
74014145|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.19||0.668|TWO_SIDED|95.0|-0.45|0.29|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.29|-0.45|0.668
74014146|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-0.84|0.005
74014147|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.88|-0.19|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-0.88|0.002
74014148|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.22||0.032|TWO_SIDED|95.0|-0.89|-0.04|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.04|-0.89|0.032
74014149|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.21|-0.41|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.21|<0.001
74014150|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.28|-0.48|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.48|-1.28|<0.001
74014151|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.773|TWO_SIDED|95.0|-0.46|0.34|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.34|-0.46|0.773
74043353|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.12|||||TWO_SIDED|95.0|-22.13|15.88|||||Day 8, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 8||15.88|-22.13|
74043354|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-1.38|||||TWO_SIDED|95.0|-20.4|17.63|||||Day 8, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 8||17.63|-20.40|
74094730|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|1.17|2.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.33|1.17|<0.001
74094731|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|4.06|||<|0.001|TWO_SIDED|95.0|3.25|4.88|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.88|3.25|<0.001
74094732|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08|||<|0.001|TWO_SIDED|95.0|2.26|3.9|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.90|2.26|<0.001
74014152|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.78|-0.03|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.03|-0.78|0.035
74094733|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.41|1.56|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.56|0.41|<0.001
74094734|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|4.67|||<|0.001|TWO_SIDED|95.0|3.82|5.52|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.52|3.82|<0.001
74094735|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.01|TWO_SIDED|95.0|0.19|1.38|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.38|0.19|0.010
74094736|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|2.41|||<|0.001|TWO_SIDED|95.0|1.81|3.01|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.01|1.81|<0.001
74094737|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.89|||<|0.001|TWO_SIDED|95.0|3.04|4.74|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.74|3.04|<0.001
74094738|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.4|3.11|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.11|1.40|<0.001
74043355|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.71|||||TWO_SIDED|95.0|-19.7|18.28|||||Day 8, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8||18.28|-19.70|
74043356|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|3.02|||||TWO_SIDED|95.0|-15.98|22.02|||||Day 8, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8||22.02|-15.98|
74043357|NCT01602549|147638486|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|4.08|||||TWO_SIDED|95.0|-14.91|23.07|||||Day 8, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8||23.07|-14.91|
74043358|NCT02823080|147638506|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74043359|NCT02823080|147638507|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74043360|NCT02823080|147638508|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74043361|NCT02823080|147638512|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74043362|NCT00511108|147638513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.7||||0.002||95.0|-48.7|-10.6|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate||||-10.6|-48.7|0.002
74043363|NCT00511108|147638514|SUPERIORITY_OR_OTHER||Geometric Mean Difference|73.8|||<|0.001||95.0|44.2|104.4|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and log-scaled baseline value as a covariate|The outcome was analyzed by ANCOVA on the log scale. Results have been back-transformed to the original scale.|||104.4|44.2|<0.001
74043364|NCT00511108|147638515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-407.8|||<|0.001||95.0|-513.4|-302.1|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate||||-302.1|-513.4|<0.001
74043365|NCT01392742|147638553|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for RVR at Week 4.||||0.000
74043366|NCT01392742|147638553|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Regression, Linear|||Binary logistic regression for gender at Week 4.||||0.018
74043367|NCT01392742|147638553|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 4.||||0.062
74043368|NCT01392742|147638553|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for HCV genotype at Week 4.||||0.050
74094739|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63|||<|0.001|TWO_SIDED|95.0|1.02|2.23|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.23|1.02|<0.001
74094740|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|4.53|||<|0.001|TWO_SIDED|95.0|3.65|5.4|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.40|3.65|<0.001
74043369|NCT01392742|147638553|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for height at Week 4.||||0.001
74043370|NCT01392742|147638553|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 4.||||0.001
74043371|NCT01392742|147638553|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for EVR at Week 12.||||0.037
74043372|NCT01392742|147638553|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for gender at Week 12.||||0.018
74094741|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82||||0.009|TWO_SIDED|95.0|0.21|1.43|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.43|0.21|0.009
74094742|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|2.42|||<|0.001|TWO_SIDED|95.0|1.79|3.04|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.04|1.79|<0.001
74094743|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.71|||<|0.001|TWO_SIDED|95.0|2.83|4.58|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.58|2.83|<0.001
74094744|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|||<|0.001|TWO_SIDED|95.0|1.23|2.99|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.99|1.23|<0.001
74094745|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|0.97|2.22|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.22|0.97|<0.001
74043373|NCT01392742|147638553|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 12.||||0.092
74043374|NCT01392742|147638553|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for height at Week 12.||||0.001
74094746|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|4.27|||<|0.001|TWO_SIDED|95.0|3.37|5.17|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.17|3.37|<0.001
74094747|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.012|TWO_SIDED|95.0|0.18|1.44|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.44|0.18|0.012
74094748|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|||<|0.001|TWO_SIDED|95.0|1.72|3.0|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.00|1.72|<0.001
74094749|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.47|||<|0.001|TWO_SIDED|95.0|2.57|4.36|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.36|2.57|<0.001
74094750|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|||<|0.001|TWO_SIDED|95.0|1.0|2.82|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.82|1.00|<0.001
74094751|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55|||<|0.001|TWO_SIDED|95.0|0.92|2.19|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.19|0.92|<0.001
74094752|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.68|||<|0.001|TWO_SIDED|95.0|2.76|4.6|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.60|2.76|<0.001
74014153|NCT00876187|147578988|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.014|TWO_SIDED|95.0|-0.85|-0.1|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-0.85|0.014
74014154|NCT01560780|147579024|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
74014155|NCT01560780|147579025|EQUIVALENCE|safety end-point with p-value of \<0.05|||||>|0.99|||||||Log Rank|||||||>0.99
74014156|NCT01560780|147579026|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
74094753|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.055|TWO_SIDED|95.0|-0.01|1.27|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.27|-0.01|0.055
74094754|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|2.19|||<|0.001|TWO_SIDED|95.0|1.54|2.84|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.84|1.54|<0.001
74094755|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.05|||<|0.001|TWO_SIDED|95.0|2.14|3.97|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.97|2.14|<0.001
74094756|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.49||||0.002|TWO_SIDED|95.0|0.57|2.42|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.42|0.57|0.002
74094757|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|0.91|2.21|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.21|0.91|<0.001
74094758|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1|||<|0.001|TWO_SIDED|95.0|2.17|4.03|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.03|2.17|<0.001
74014157|NCT01560780|147579027|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||||||0.85
74014158|NCT01560780|147579028|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
74014159|NCT01560780|147579030|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
74094759|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.049|TWO_SIDED|95.0|0.0|1.3|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.30|0.00|0.049
74094760|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.93|||<|0.001|TWO_SIDED|95.0|1.27|2.59|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.59|1.27|<0.001
74094761|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|2.44|||<|0.001|TWO_SIDED|95.0|1.52|3.37|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.37|1.52|<0.001
74094762|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.015|TWO_SIDED|95.0|0.23|2.1|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.10|0.23|0.015
74014160|NCT05074251|147579047|SUPERIORITY||Risk Ratio (RR)|1.41|||<|0.05|TWO_SIDED|95.0|1.14|1.75|||Regression, Logistic|||||1.75|1.14|<0.05
74014161|NCT02915523|147579053|OTHER||Hazard Ratio (HR)|0.899|||||TWO_SIDED|95.0|0.581|1.393|||||Stratified HR estimated from a stratified univeriate Cox proportional hazards model. Avelumab + placebo was the reference treatment group.|||1.393|0.581|
74043375|NCT01392742|147638553|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 12.||||0.042
74043376|NCT00810043|147638587|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Anterior vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.430
74043377|NCT00810043|147638587|SUPERIORITY_OR_OTHER|||||||0.643|||||||t-test, 2 sided|||Middle vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.643
74043378|NCT00810043|147638587|SUPERIORITY_OR_OTHER|||||||0.165|||||||t-test, 2 sided|||Posterior vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.165
74043379|NCT00810043|147638588|SUPERIORITY_OR_OTHER|||||||0.402|||||||t-test, 2 sided|||Anterior VBH restored||||0.402
74043380|NCT00810043|147638588|SUPERIORITY_OR_OTHER|||||||0.578|||||||t-test, 2 sided|||Middle VBH restored||||0.578
74014162|NCT01179009|147579081|SUPERIORITY|||||||0.53||||||The p-value above represents the interaction between the treatment group and time.|ANOVA|||||||0.53
74014163|NCT01179009|147579082|SUPERIORITY|||||||0.06||||||The p-value above comes from a model where the treatment group is used to predict the CGI improvement score.|Ordinal regression|||||||0.06
74014164|NCT00401375|147579092|OTHER||Mean Difference (Final Values)|-0.23||||0.4259||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.||||0.4259
74014165|NCT00401375|147579092|OTHER||Mean Difference (Final Values)|0.13||||0.3575||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.||||0.3575
74043381|NCT00810043|147638588|SUPERIORITY_OR_OTHER|||||||0.166|||||||t-test, 2 sided|||Posterior VBH restored||||0.166
74043382|NCT00810043|147638590|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||Anterior VBH gained by postural reduction||||0.900
74043383|NCT00810043|147638590|SUPERIORITY_OR_OTHER|||||||0.62|||||||t-test, 2 sided|||Middle VBH gained by postural reduction||||0.620
74043384|NCT00810043|147638590|SUPERIORITY_OR_OTHER|||||||0.349|||||||t-test, 2 sided|||Posterior VBH gained by postural reduction||||0.349
74043385|NCT00810043|147638591|SUPERIORITY_OR_OTHER|||||||0.889|||||||t-test, 2 sided|||||||0.889
74014166|NCT03152019|147579096|SUPERIORITY||percentages|0.77|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
74043386|NCT00810043|147638592|SUPERIORITY_OR_OTHER|||||||0.486|||||||t-test, 2 sided|||||||0.486
74014167|NCT00350142|147579106|SUPERIORITY_OR_OTHER||proportion|0.75|||||TWO_SIDED|||||||||||||
74014168|NCT00610987|147579116|SUPERIORITY_OR_OTHER||||||=|0.12|TWO_SIDED||||||t-test, 1 sided|||||||=0.12
74014169|NCT00254501|147579117|SUPERIORITY_OR_OTHER|||||||0.0757||||||Adjusted for baseline Hemoglobin A-1C.|ANCOVA|||"Null hypothesis is mean change in usual care group equals mean change in Empower group.~Power calculation required 150 per group assuming 25% would withdraw prior to 12 months."||||0.0757
74014170|NCT00254501|147579118|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANCOVA|||Comparison of change in LDL from baseline to 12 months between groups.||||0.44
74014171|NCT00254501|147579118|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANCOVA|||Comparison of change in HDL from baseline to 12 months between groups.||||0.16
74014172|NCT00254501|147579118|SUPERIORITY_OR_OTHER|||||||0.14|||||||ANCOVA|||Comparison of change in total cholesterol from baseline to 12 months between groups.||||0.14
74043387|NCT00810043|147638593|SUPERIORITY_OR_OTHER|||||||0.144|||||||t-test, 2 sided|||||||0.144
74043388|NCT00810043|147638594|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.360
74043389|NCT01359046|147638595|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
74043390|NCT01359046|147638596|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
74014173|NCT00254501|147579118|SUPERIORITY_OR_OTHER|||||||0.92|||||||ANCOVA|||Comparison of change in triglycerides from baseline to 12 months between groups.||||0.92
74014174|NCT00254501|147579119|SUPERIORITY_OR_OTHER|||||||0.3856|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of total health care from baseline to 12 months between groups. Analyses not adjusted for other variables.||||.3856
74014175|NCT00254501|147579119|SUPERIORITY_OR_OTHER|||||||0.6413|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of diabetes medications from baseline to 12 months between groups. Analyses not adjusted for other variables.||||.6413
74014176|NCT00254501|147579119|SUPERIORITY_OR_OTHER|||||||0.4303|||||||Wilcoxon (Mann-Whitney)|||Analyses not adjusted for other variables.||||.4303
74043391|NCT03364491|147638601|SUPERIORITY|Model included treatment and preoperative hemoglobin level \<8 g/dL (yes/no) as covariates. We estimated that a total sample size of 11,000 participants (5,500 per group) would achieve 85% power to detect a 33% lower incidence of the primary outcome (1.67%) in the TXA group, at a type I error rate (two-sided) of 5%.|Risk Ratio (RR)|0.89||||0.19|TWO_SIDED|95.26|0.74|1.07||Following two interim analyses, a two-tailed P value of less than 0.047 was considered to indicate statistical significance.|Other (Log-binomial regression model)|||||1.07|0.74|0.19
74043392|NCT04539262|147638615|SUPERIORITY||Least Square Mean Difference by Day 7|-0.66|STANDARD_ERROR_OF_MEAN|0.4||0.1117|TWO_SIDED|95.0|-1.49|0.16||Least square (LS) Mean, Standard Error (SE), 95% CI and p-value were from Analysis of covariance (ANCOVA) with baseline viral load as a covariate.|ANCOVA|||||0.16|-1.49|0.1117
74043393|NCT04539262|147638615|SUPERIORITY||LS Mean Difference by Day 7|-0.35|STANDARD_ERROR_OF_MEAN|0.4||0.3793|TWO_SIDED|95.0|-1.16|0.46||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.46|-1.16|0.3793
74043394|NCT04539262|147638615|SUPERIORITY||LS Mean Difference by Day 7|-0.24|STANDARD_ERROR_OF_MEAN|0.37||0.5248|TWO_SIDED|95.0|-1.0|0.52||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate|ANCOVA|||||0.52|-1.00|0.5248
74014177|NCT00254501|147579120|SUPERIORITY_OR_OTHER|||||||0.785|||||||ANCOVA|||Comparison of change in Diabetes Empowerment Scale from baseline to 12 months between groups.||||0.785
74043395|NCT04539262|147638615|SUPERIORITY||LS Mean Difference by Day 7|-0.25|STANDARD_ERROR_OF_MEAN|0.34||0.461|TWO_SIDED|95.0|-0.94|0.44|||ANCOVA|LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate||||0.44|-0.94|0.4610
74094763|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|||<|0.001|TWO_SIDED|95.0|0.62|1.94|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.94|0.62|<0.001
74014178|NCT00254501|147579120|SUPERIORITY_OR_OTHER|||||||0.302|||||||ANCOVA|||Comparison of change in Adherence Starts with Knowledge (ASK-20) from baseline to 12 months between groups.||||0.302
74014179|NCT00254501|147579120|SUPERIORITY_OR_OTHER|||||||0.0024|||||||ANCOVA|||Comparison of change in Understanding of Diabetes from baseline to 12 months between groups.||||0.0024
74014180|NCT01500759|147579180|OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0||||||||||||
74014181|NCT01500759|147579181|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0||||||||||||
74014182|NCT01500759|147579182|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|||||||||||||
74014183|NCT01500759|147579183|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0||||||||||||
74014184|NCT01290874|147579184|SUPERIORITY|||||||0.31|||||||Log Rank|||||||0.31
74014185|NCT03962439|147579231|OTHER|Null-hypothesis significance testing|F-value|1.61||||0.211|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in episodic memory from baseline to 16 weeks interacted with condition (Time x Condition).||||.211
74014186|NCT03962439|147579233|OTHER|Null hypothesis significance testing|F-value|1.66||||0.203|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in speed of processing from baseline to 16 weeks interacted with condition (Time x Condition).||||.203
74014187|NCT03962439|147579235|OTHER|Null hypothesis significance testing|F-value|0.28||||0.76|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in reasoning from baseline to week 16 interacted with condition (Time x Condition).||||.760
74014188|NCT01515787|147579333|NON_INFERIORITY|Disease recurrence or death in order to have 85% power to reject the null hypothesis. Noninferiority of the intervention could be claimed if the upper limit of the two-sided 90.2% confidence interval of the hazard ratio for disease recurrence or death did not exceed the 1.29 noninferiority margin.|Hazard Ratio (HR)|0.92||||0.005|TWO_SIDED|90.2|0.74|1.14|||kaplan meier|||||1.14|0.74|0.005
74014189|NCT01515787|147579335|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.74|1.44||||||||1.44|0.74|
74014190|NCT01515787|147579337|SUPERIORITY||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.44|3.16||||||||3.16|0.44|
74043396|NCT04539262|147638615|SUPERIORITY||LS Mean Difference by Day 7|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5006|TWO_SIDED|95.0|-0.4|0.81||LS Mean (SE), 95% CI and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.81|-0.40|0.5006
74014191|NCT04442230|147579460|SUPERIORITY|||||||0.6602|||||||Fisher Exact|||The p-values from significance tests were obtained at a one-sided significance level of 0.025.||||0.6602
74014192|NCT01604265|147579463|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.25||||0.005|TWO_SIDED|95.0|-2.11|-0.39|||ANCOVA|||The change was compared between treatment groups using a one way analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows: Change in 0-10 Numerical Rating Scale Pain Score = Baseline Pain Score + Treatment||-0.39|-2.11|0.005
74014193|NCT01604265|147579464|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.39||||0.003|TWO_SIDED|95.0|-2.27|-0.5|||ANCOVA|||"The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in 0-10 Numerical Rating Scale sleep Score = Baseline Sleep Score + Treatment"||-0.50|-2.27|0.003
74043397|NCT04539262|147638616|SUPERIORITY||LS Mean Difference by Day 7|0.33|STANDARD_ERROR_OF_MEAN|0.34||0.3417|TWO_SIDED|95.0|-0.37|1.02||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||1.02|-0.37|0.3417
74094764|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48|||<|0.001|TWO_SIDED|95.0|1.56|3.4|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.40|1.56|<0.001
74014194|NCT01604265|147579465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.896||||0.005|TWO_SIDED|95.0|1.51|10.055|||Regression, Logistic|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test. Results were presented in terms of difference in percentages, and 95% CI based on the normal approximation to the binomial, and p-value."||10.055|1.510|0.005
74014195|NCT01604265|147579466|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-6.82||||0.039|TWO_SIDED|95.0|-13.28|-0.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||-0.37|-13.28|0.039
74014196|NCT01604265|147579467|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-6.95||||0.009|TWO_SIDED|95.0|-12.12|-1.77|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||-1.77|-12.12|0.009
74014197|NCT01604265|147579468|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|2.54||||0.23|TWO_SIDED|95.0|-1.64|6.71|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||6.71|-1.64|0.230
74014198|NCT01604265|147579469|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.53||||0.064|TWO_SIDED|95.0|-5.22|0.15|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.15|-5.22|0.064
74014199|NCT01604265|147579470|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|2.44||0.905|TWO_SIDED|95.0|-4.6|5.18|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||5.18|-4.60|0.905
74014200|NCT01604265|147579471|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|2.68||||0.257|TWO_SIDED|95.0|-2.01|7.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||7.37|-2.01|0.257
74014201|NCT01604265|147579472|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.5||||0.164|TWO_SIDED|95.0|-3.64|0.63|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.63|-3.64|0.164
74014202|NCT01604265|147579474|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.09||||0.88|TWO_SIDED|95.0|-1.06|1.23|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||1.23|-1.06|0.880
74014203|NCT01604265|147579475|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.249|TWO_SIDED|95.0|-1.75|0.46|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.46|-1.75|0.249
74014204|NCT01604265|147579476|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.06||||0.535|TWO_SIDED|95.0|-0.13|0.24|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.24|-0.13|0.535
74043398|NCT04539262|147638616|SUPERIORITY||LS Mean Difference by Day 7|0.49|STANDARD_ERROR_OF_MEAN|0.35||0.1803|TWO_SIDED|95.0|-0.24|1.21||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||1.21|-0.24|0.1803
74043399|NCT04539262|147638616|SUPERIORITY||LS Mean Difference by Day 7|-0.55|STANDARD_ERROR_OF_MEAN|0.35||0.1233|TWO_SIDED|95.0|-1.27|0.16||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.16|-1.27|0.1233
74043400|NCT04539262|147638616|SUPERIORITY||LS Mean Difference by Day 7|0.08|STANDARD_ERROR_OF_MEAN|0.35||0.8203|TWO_SIDED|95.0|-0.64|0.8||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.80|-0.64|0.8203
74043401|NCT04539262|147638616|SUPERIORITY||LS Mean Difference by Day 7|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.6458|TWO_SIDED|95.0|-0.65|0.41||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.41|-0.65|0.6458
74043402|NCT04539262|147638617|SUPERIORITY||LS Mean Difference by Day 7|-0.22|STANDARD_ERROR_OF_MEAN|0.4||0.5951|TWO_SIDED|95.0|-1.05|0.61||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.61|-1.05|0.5951
74043403|NCT04539262|147638617|SUPERIORITY|LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|LS Mean Difference by Day 7|-0.71|STANDARD_ERROR_OF_MEAN|0.4||0.0872|TWO_SIDED|95.0|-1.54|0.11|||ANCOVA|||||0.11|-1.54|0.0872
74043404|NCT04539262|147638617|SUPERIORITY||LS Mean Difference by Day 7|-0.19|STANDARD_ERROR_OF_MEAN|0.36||0.6031|TWO_SIDED|95.0|-0.94|0.56||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.56|-0.94|0.6031
74043405|NCT04539262|147638617|SUPERIORITY||LS Mean Difference by Day 7|0.12|STANDARD_ERROR_OF_MEAN|0.37||0.7578|TWO_SIDED|95.0|-0.64|0.87||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.87|-0.64|0.7578
74043406|NCT04539262|147638617|SUPERIORITY||LS Mean Difference by Day 7|0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8846|TWO_SIDED|95.0|-0.48|0.56||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.56|-0.48|0.8846
74043407|NCT02665468|147638650|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
74043408|NCT02052141|147638686|SUPERIORITY||Mean difference|-0.4|STANDARD_DEVIATION|0.58||0.03|TWO_SIDED|90.0|-0.71|-0.1|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.10|-0.71|0.03
74043409|NCT02052141|147638687|SUPERIORITY||Mean difference|-0.7|STANDARD_DEVIATION|1.06||0.05|TWO_SIDED|90.0|-1.2|-0.11|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.11|-1.20|0.05
74043410|NCT02052141|147638688|SUPERIORITY||Mean difference|-1.9|STANDARD_DEVIATION|2.82||0.04|TWO_SIDED|90.0|-3.31|-0.38|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.38|-3.31|0.04
74043411|NCT02052141|147638689|SUPERIORITY||Mean difference|-0.2|STANDARD_DEVIATION|0.37||0.07|TWO_SIDED|90.0|-0.41|-0.03|||Paired t-test||The difference between treatment B over treatment A was estimated|||-0.03|-0.41|0.07
74043412|NCT00291187|147638702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|||<|0.001|TWO_SIDED|95.0|-33.1|-9.9|||ANCOVA|||||-9.9|-33.1|<0.001
74043413|NCT00291187|147638702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.3|||<|0.001|TWO_SIDED|95.0|-37.8|-14.7|||ANCOVA|||||-14.7|-37.8|<0.001
74043414|NCT00291187|147638702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8|||<|0.001|TWO_SIDED|95.0|-34.2|-11.3|||ANCOVA|||||-11.3|-34.2|<0.001
74043415|NCT00291187|147638703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2||||0.017|TWO_SIDED|95.0|-44.1|-4.3|||ANCOVA|||||-4.3|-44.1|0.017
74043416|NCT00291187|147638703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.7||||0.001|TWO_SIDED|95.0|-53.6|-13.9|||ANCOVA|||||-13.9|-53.6|0.001
74043417|NCT00291187|147638703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4||||0.081|TWO_SIDED|95.0|-37.0|2.1|||ANCOVA|||||2.1|-37.0|0.081
74043418|NCT00291187|147638704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.7||||0.002|TWO_SIDED|95.0|13.0|54.5|||ANCOVA|||||54.5|13.0|0.002
74043419|NCT00291187|147638704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.9|||<|0.001|TWO_SIDED|95.0|27.2|68.6|||ANCOVA|||||68.6|27.2|<0.001
74043420|NCT00291187|147638704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.6||||0.005|TWO_SIDED|95.0|9.1|50.0|||ANCOVA|||||50.0|9.1|0.005
74043421|NCT00291187|147638705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1||||0.006|TWO_SIDED|95.0|-18.9|-3.3|||ANCOVA|||||-3.3|-18.9|0.006
74043422|NCT00291187|147638705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.3|||<|0.001|TWO_SIDED|95.0|-22.1|-6.5|||ANCOVA|||||-6.5|-22.1|<0.001
74014205|NCT02706873|147579478|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|23.7|||<|0.001|TWO_SIDED|95.0|16.3|31.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||31.1|16.3|<0.001
74043423|NCT00291187|147638705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3||||0.002|TWO_SIDED|95.0|-20.0|-4.6|||ANCOVA|||||-4.6|-20.0|0.002
74043424|NCT00047853|147638706|OTHER||||||<|0.001|||||||ANOVA|||||||< 0.001
74043425|NCT00047853|147638707|OTHER|||||||9.3e-05|||||||t-test, 2 sided|||||||0.000093
74043426|NCT02443805|147638719|SUPERIORITY||||||<|0.0001||||||Source Model: Type III effects Covariates: Treatment group, Gender, Age Class, Sensitization Status, Asthma Status, Pooled Center, Baseline Average RTSS.|ANCOVA|||||||<0.0001
74043427|NCT04362813|147638722|SUPERIORITY||Odds Ratio (OR)|1.39||||0.2874|TWO_SIDED|95.0|0.76|2.54|||Regression, Logistic|||Odds ratio is based on a Logistic regression model adjusted by treatment, region (North America vs Europe), and baseline 9-point ordinal scale (\<=4, \>=5).||2.54|0.76|0.2874
74043428|NCT04362813|147638723|SUPERIORITY||Odds Ratio (OR)|0.67||||0.3303|TWO_SIDED|95.0|0.3|1.5|||Regression, Logistic|||Odds ratio is based on a Logistic regression model adjusted by treatment, region (North America vs Europe), and baseline 9-point ordinal scale (\<=4, \>=5)||1.50|0.30|0.3303
74043429|NCT01515488|147638750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.3|STANDARD_ERROR_OF_MEAN|5.2|<|0.0005|TWO_SIDED|95.0|22.1|42.6|||t-test, 2 sided|DF=331.2||||42.6|22.1|<0.0005
74043430|NCT01975675|147638768|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment-naive noncirrhotic participants in the LDV/SOF (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test|||||||< 0.001
74043431|NCT01975675|147638768|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment-naive noncirrhotic participants in the LDV/SOF+RBV (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test|||||||< 0.001
74043432|NCT01975675|147638769|SUPERIORITY_OR_OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.2|1.0|||||The 95% confidence interval (CI) on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).|||1.0|-10.2|
74043433|NCT01975675|147638769|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-4.2|4.2|||||The 95% CI on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).|||4.2|-4.2|
74043434|NCT00753688|147638776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.26|0.48||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.48|0.26|<0.001
74014206|NCT02706873|147579478|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|28.0|||<|0.001|TWO_SIDED|95.0|20.6|35.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||35.4|20.6|<0.001
74014207|NCT02706873|147579479|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|29.8|||<|0.001|TWO_SIDED|95.0|22.8|36.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||36.8|22.8|<0.001
74014208|NCT02706873|147579479|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|24.5|38.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||38.5|24.5|<0.001
74043435|NCT00753688|147638777|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.256|TWO_SIDED|95.0|0.67|1.12||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||1.12|0.67|0.256
74043436|NCT00753688|147638781|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.23|0.6||Stratified two-sided log rank p-value for leiomyosarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.60|0.23|<0.001
74043437|NCT00753688|147638781|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.005|TWO_SIDED|95.0|0.19|0.98||Stratified two-sided log rank p-value for synovial sarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.98|0.19|0.005
74043438|NCT00753688|147638781|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.25|0.6||Stratified two-sided log rank p-value for other STS histologies|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.60|0.25|<0.001
74043439|NCT03803202|147638800|OTHER||Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.7|1.85|||t-test, 2 sided|||Serotype 1, Day 1||1.85|0.70|
74094765|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.087|TWO_SIDED|95.0|-0.08|1.2|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.20|-0.08|0.087
74043440|NCT03803202|147638800|OTHER||Ratio of GMT|1.17|||||TWO_SIDED|95.0|0.72|1.9|||t-test, 2 sided|||Serotype 1, Day 1||1.90|0.72|
74043441|NCT03803202|147638800|OTHER||Ratio of GMT|1.17|||||TWO_SIDED|95.0|0.74|1.87|||t-test, 2 sided|||Serotype 1, Day 1||1.87|0.74|
74094766|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.47|||<|0.001|TWO_SIDED|95.0|0.82|2.12|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.12|0.82|<0.001
74043442|NCT03803202|147638800|OTHER||Ratio of GMT|1.57|||||TWO_SIDED|95.0|0.68|3.63|||t-test, 2 sided|||Serotype 3, Day 1||3.63|0.68|
74043443|NCT03803202|147638800|OTHER||Ratio of GMT|2.04|||||TWO_SIDED|95.0|0.86|4.82|||t-test, 2 sided|||Serotype 3, Day 1||4.82|0.86|
74043444|NCT03803202|147638800|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.31|1.46|||t-test, 2 sided|||Serotype 3, Day 1||1.46|0.31|
74043445|NCT03803202|147638800|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.27|4.55|||t-test, 2 sided|||Serotype 4, Day 1||4.55|0.27|
74094767|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.92|||<|0.001|TWO_SIDED|95.0|1.0|2.84|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.84|1.00|<0.001
74094768|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01||||0.032|TWO_SIDED|95.0|0.09|1.94|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.94|0.09|0.032
74094769|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.006|TWO_SIDED|95.0|0.26|1.56|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.56|0.26|0.006
74014209|NCT02706873|147579480|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|21.6|||<|0.001|TWO_SIDED|95.0|14.3|28.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||28.8|14.3|<0.001
74014210|NCT02706873|147579480|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|22.9|||<|0.001|TWO_SIDED|95.0|15.7|30.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||30.1|15.7|<0.001
74014211|NCT02706873|147579481|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Least Squares (LS) Mean Difference|-0.53||||0.001|TWO_SIDED|95.0|-0.85|-0.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, geographic region as fixed factors and baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||-0.20|-0.85|0.001
74043446|NCT03803202|147638800|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.19|2.61|||t-test, 2 sided|||Serotype 4, Day 1||2.61|0.19|
74043447|NCT03803202|147638800|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|0.49|6.85|||t-test, 2 sided|||Serotype 4, Day 1||6.85|0.49|
74043448|NCT03803202|147638800|OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|0.76|4.73|||t-test, 2 sided|||Serotype 5, Day 1||4.73|0.76|
74043449|NCT03803202|147638800|OTHER||Ratio of GMT|1.22|||||TWO_SIDED|95.0|0.62|2.4|||t-test, 2 sided|||Serotype 5, Day 1||2.40|0.62|
74043450|NCT03803202|147638800|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.52|1.65|||t-test, 2 sided|||Serotype 5, Day 1||1.65|0.52|
74043451|NCT03803202|147638800|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.25|2.82|||t-test, 2 sided|||Serotype 6A, Day 1||2.82|0.25|
74014212|NCT02706873|147579481|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.91|-0.27||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||-0.27|-0.91|<0.001
74043452|NCT03803202|147638800|OTHER||Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.24|2.23|||t-test, 2 sided|||Serotype 6A, Day 1||2.23|0.24|
74043453|NCT03803202|147638800|OTHER||Ratio of GMT|1.03|||||TWO_SIDED|95.0|0.31|3.41|||t-test, 2 sided|||Serotype 6A, Day 1||3.41|0.31|
74043454|NCT03803202|147638800|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.32|4.46|||t-test, 2 sided|||Serotype 6B,Day 1||4.46|0.32|
74043455|NCT03803202|147638800|OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.42|4.05|||t-test, 2 sided|||Serotype 6B, Day 1||4.05|0.42|
74043456|NCT03803202|147638800|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.24|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.24|
74043457|NCT03803202|147638800|OTHER||Ratio of GMT|0.76|||||TWO_SIDED|95.0|0.26|2.17|||t-test, 2 sided|||Serotype 7F, Day 1||2.17|0.26|
74043458|NCT03803202|147638800|OTHER||Ratio of GMT|0.32|||||TWO_SIDED|95.0|0.11|0.89|||t-test, 2 sided|||Serotype 7F, Day 1||0.89|0.11|
74043459|NCT03803202|147638800|OTHER||Ratio of GMT|0.31|||||TWO_SIDED|95.0|0.1|0.93|||t-test, 2 sided|||Serotype 7F, Day 1||0.93|0.10|
74043460|NCT03803202|147638800|OTHER||Ratio of GMT|1.92|||||TWO_SIDED|95.0|0.74|4.99|||t-test, 2 sided|||Serotype 9V, Day 1||4.99|0.74|
74043461|NCT03803202|147638800|OTHER||Ratio of GMT|0.48|||||TWO_SIDED|95.0|0.15|1.61|||t-test, 2 sided|||Serotype 9V, Day 1||1.61|0.15|
74043462|NCT03803202|147638800|OTHER||Ratio of GMT|0.62|||||TWO_SIDED|95.0|0.21|1.9|||t-test, 2 sided|||Serotype 9V, Day 1||1.90|0.21|
74043463|NCT03803202|147638800|OTHER||Ratio of GMT|4.2|||||TWO_SIDED|95.0|1.17|15.09|||t-test, 2 sided|||Serotype 14, Day 1||15.09|1.17|
74043464|NCT03803202|147638800|OTHER||Ratio of GMT|1.91|||||TWO_SIDED|95.0|0.52|7.07|||t-test, 2 sided|||Serotype 14, Day 1||7.07|0.52|
74043465|NCT03803202|147638800|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.23|4.25|||t-test, 2 sided|||Serotype 14, Day 1||4.25|0.23|
74043466|NCT03803202|147638800|OTHER||Ratio of GMT|0.74|||||TWO_SIDED|95.0|0.21|2.62|||t-test, 2 sided|||Serotype 18C, Day 1||2.62|0.21|
74014213|NCT02706873|147579482|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.88|||<|0.001|TWO_SIDED|95.0|-1.09|-0.67||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.||||-0.67|-1.09|<0.001
74043467|NCT03803202|147638800|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.37|3.77|||t-test, 2 sided|||Serotype 18C, Day 1||3.77|0.37|
74014214|NCT02706873|147579482|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-1.01|||<|0.001|TWO_SIDED|95.0|-1.21|-0.8||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.80|-1.21|<0.001
74014215|NCT02706873|147579483|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.25||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.25|-0.44|<0.001
74014216|NCT02706873|147579483|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.37|||<|0.001|TWO_SIDED|95.0|-0.47|-0.28||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.28|-0.47|<0.001
74014217|NCT02706873|147579484|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|25.0|||<|0.001|TWO_SIDED|95.0|17.6|32.4||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||32.4|17.6|<0.001
74014218|NCT02706873|147579484|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|26.4|||<|0.001|TWO_SIDED|95.0|19.0|33.9||The nominal p-value is reported|Chi-squared, Corrected|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|||Response Rate Difference = Upadacitinib - Methotrexate|33.9|19.0|<0.001
74014219|NCT02706873|147579485|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.25|||<|0.001|TWO_SIDED|95.0|3.0|5.5||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.50|3.00|<0.001
74014220|NCT02706873|147579485|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.34|||<|0.001|TWO_SIDED|95.0|3.09|5.59||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.59|3.09|<0.001
74014221|NCT02706873|147579486|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.92|||<|0.001|TWO_SIDED|95.0|-1.12|-0.71||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.71|-1.12|<0.001
74014222|NCT02706873|147579486|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-1.19|||<|0.001|TWO_SIDED|95.0|-1.4|-0.99||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.99|-1.40|<0.001
74043468|NCT03803202|147638800|OTHER||Ratio of GMT|1.22|||||TWO_SIDED|95.0|0.38|3.94|||t-test, 2 sided|||Serotype 18C, Day 1||3.94|0.38|
74043469|NCT03803202|147638800|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.51|2.45|||t-test, 2 sided|||Serotype 19A, Day 1||2.45|0.51|
74014223|NCT02706873|147579487|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.37|-0.17||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.17|-0.37|<0.001
74043470|NCT03803202|147638800|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.31|1.63|||t-test, 2 sided|||Serotype 19A, Day 1||1.63|0.31|
74043471|NCT03803202|147638800|OTHER||Ratio of GMT|0.74|||||TWO_SIDED|95.0|0.36|1.53|||t-test, 2 sided|||Serotype 19A, Day 1||1.53|0.36|
74043472|NCT03803202|147638800|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.24|2.08|||t-test, 2 sided|||Serotype 19F, Day 1||2.08|0.24|
74043473|NCT03803202|147638800|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.44|3.5|||t-test, 2 sided|||Serotype 19F, Day 1||3.50|0.44|
74043474|NCT03803202|147638800|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.58|3.61|||t-test, 2 sided|||Serotype 19F, Day 1||3.61|0.58|
74014224|NCT02706873|147579487|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.41|-0.21||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.21|-0.41|<0.001
74014225|NCT02706873|147579488|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|26.8|||<|0.001|TWO_SIDED|95.0|19.3|34.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||34.3|19.3|<0.001
74014226|NCT02706873|147579488|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.2|||<|0.001|TWO_SIDED|95.0|24.8|39.6||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||39.6|24.8|<0.001
74043475|NCT03803202|147638800|OTHER||Ratio of GMT|2.22|||||TWO_SIDED|95.0|0.46|10.69|||t-test, 2 sided|||Serotype 23F, Day 1||10.69|0.46|
74043476|NCT03803202|147638800|OTHER||Ratio of GMT|1.36|||||TWO_SIDED|95.0|0.31|5.99|||t-test, 2 sided|||Serotype 23F, Day 1||5.99|0.31|
74043477|NCT03803202|147638800|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.15|3.01|||t-test, 2 sided|||Serotype 23F, Day 1||3.01|0.15|
74094770|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|0.85|2.66|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.66|0.85|<0.001
74094771|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.669|TWO_SIDED|95.0|-0.49|0.77|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.77|-0.49|0.669
74094772|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.89||||0.007|TWO_SIDED|95.0|0.24|1.53|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.53|0.24|0.007
74014227|NCT02706873|147579489|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|27.8|||<|0.001|TWO_SIDED|95.0|20.3|35.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||35.2|20.3|<0.001
74043478|NCT03803202|147638800|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.5|1.74|||t-test, 2 sided|||Serotype 1, Day 30||1.74|0.50|
74043479|NCT03803202|147638800|OTHER||Ratio of GMT|0.72|||||TWO_SIDED|95.0|0.39|1.32|||t-test, 2 sided|||Serotype 1, Day 30||1.32|0.39|
74043480|NCT03803202|147638800|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.35|1.39|||t-test, 2 sided|||Serotype 1, Day 30||1.39|0.35|
74043481|NCT03803202|147638800|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.66|1.8|||t-test, 2 sided|||Serotype 3, Day 30||1.80|0.66|
74043482|NCT03803202|147638800|OTHER||Ratio of GMT|1.44|||||TWO_SIDED|95.0|0.9|2.29|||t-test, 2 sided|||Serotype 3, Day 30||2.29|0.90|
74043483|NCT03803202|147638800|OTHER||Ratio of GMT|1.28|||||TWO_SIDED|95.0|0.76|2.17|||t-test, 2 sided|||Serotype 3, Day 30||2.17|0.76|
74043484|NCT03803202|147638800|OTHER||Ratio of GMT|0.82|||||TWO_SIDED|95.0|0.5|1.35|||t-test, 2 sided|||Serotype 4, Day 30||1.35|0.50|
74043485|NCT03803202|147638800|OTHER||Ratio of GMT|0.5|||||TWO_SIDED|95.0|0.24|1.02|||t-test, 2 sided|||Serotype 4, Day 30||1.02|0.24|
74094773|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|||<|0.001|TWO_SIDED|95.0|0.71|2.52|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.52|0.71|<0.001
74094774|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.063|TWO_SIDED|95.0|-0.05|1.78|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.78|-0.05|0.063
74094775|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75||||0.022|TWO_SIDED|95.0|0.11|1.39|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.39|0.11|0.022
74094776|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22||||0.008|TWO_SIDED|95.0|0.32|2.12|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.12|0.32|0.008
74014228|NCT02706873|147579489|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.8|||<|0.001|TWO_SIDED|95.0|25.4|40.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||40.2|25.4|<0.001
74014229|NCT02706873|147579490|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|3.72|||<|0.001|TWO_SIDED|95.0|2.42|5.03||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.03|2.42|<0.001
74043486|NCT03803202|147638800|OTHER||Ratio of GMT|1.06|||||TWO_SIDED|95.0|0.6|1.89|||t-test, 2 sided|||Serotype 4, Day 30||1.89|0.60|
74043487|NCT03803202|147638800|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.41|1.15|||t-test, 2 sided|||Serotype 5, Day 30||1.15|0.41|
74043488|NCT03803202|147638800|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.31|1.2|||t-test, 2 sided|||Serotype 5, Day 30||1.20|0.31|
74043489|NCT03803202|147638800|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.48|1.32|||t-test, 2 sided|||Serotype 5, Day 30||1.32|0.48|
74043490|NCT03803202|147638800|OTHER||Ratio of GMT|0.52|||||TWO_SIDED|95.0|0.28|0.98|||t-test, 2 sided|||Serotype 6A, Day 30||0.98|0.28|
74043491|NCT03803202|147638800|OTHER||Ratio of GMT|0.32|||||TWO_SIDED|95.0|0.15|0.68|||t-test, 2 sided|||Serotype 6A, Day 30||0.68|0.15|
74043492|NCT03803202|147638800|OTHER||Ratio of GMT|0.37|||||TWO_SIDED|95.0|0.21|0.66|||t-test, 2 sided|||Serotype 6A, Day 30||0.66|0.21|
74043493|NCT03803202|147638800|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.42|1.18|||t-test, 2 sided|||Serotype 6B, Day 30||1.18|0.42|
74043494|NCT03803202|147638800|OTHER||Ratio of GMT|0.45|||||TWO_SIDED|95.0|0.25|0.83|||t-test, 2 sided|||Serotype 6B, Day 30||0.83|0.25|
74043495|NCT03803202|147638800|OTHER||Ratio of GMT|0.43|||||TWO_SIDED|95.0|0.24|0.76|||t-test, 2 sided|||Serotype 6B, Day 30||0.76|0.24|
74043496|NCT03803202|147638800|OTHER||Ratio of GMT|0.81|||||TWO_SIDED|95.0|0.51|1.29|||t-test, 2 sided|||Serotype 7F, Day 30||1.29|0.51|
74043497|NCT03803202|147638800|OTHER||Ratio of GMT|0.68|||||TWO_SIDED|95.0|0.47|0.99|||t-test, 2 sided|||Serotype 7F, Day 30||0.99|0.47|
74043498|NCT03803202|147638800|OTHER||Ratio of GMT|0.82|||||TWO_SIDED|95.0|0.53|1.25|||t-test, 2 sided|||Serotype 7F, Day 30||1.25|0.53|
74043499|NCT03803202|147638800|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.35|1.08|||t-test, 2 sided|||Serotype 9V, Day 30||1.08|0.35|
74043500|NCT03803202|147638800|OTHER||Ratio of GMT|0.57|||||TWO_SIDED|95.0|0.31|1.03|||t-test, 2 sided|||Serotype 9V, Day 30||1.03|0.31|
74043501|NCT03803202|147638800|OTHER||Ratio of GMT|0.77|||||TWO_SIDED|95.0|0.46|1.28|||t-test, 2 sided|||Serotype 9V, Day 30||1.28|0.46|
74043502|NCT03803202|147638800|OTHER||Ratio of GMT|0.54|||||TWO_SIDED|95.0|0.27|1.08|||t-test, 2 sided|||Serotype 14, Day 30||1.08|0.27|
74043503|NCT03803202|147638800|OTHER||Ratio of GMT|0.28|||||TWO_SIDED|95.0|0.1|0.77|||t-test, 2 sided|||Serotype 14, Day 30||0.77|0.10|
74043504|NCT03803202|147638800|OTHER||Ratio of GMT|1.13|||||TWO_SIDED|95.0|0.56|2.3|||t-test, 2 sided|||Serotype 14, Day 30||2.30|0.56|
74043505|NCT03803202|147638800|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.53|1.5|||t-test, 2 sided|||Serotype 18C, Day 30||1.50|0.53|
74043506|NCT03803202|147638800|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.39|1.23|||t-test, 2 sided|||Serotype 18C, Day 30||1.23|0.39|
74043507|NCT03803202|147638800|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.5|1.28|||t-test, 2 sided|||Serotype 18C, Day 30||1.28|0.50|
74043508|NCT03803202|147638800|OTHER||Ratio of GMT|0.5|||||TWO_SIDED|95.0|0.32|0.79|||t-test, 2 sided|||Serotype 19A, Day 30||0.79|0.32|
74043509|NCT03803202|147638800|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.45|1.09|||t-test, 2 sided|||Serotype 19A, Day 30||1.09|0.45|
74043510|NCT03803202|147638800|OTHER||Ratio of GMT|0.63|||||TWO_SIDED|95.0|0.42|0.96|||t-test, 2 sided|||Serotype 19A, Day 30||0.96|0.42|
74043511|NCT03803202|147638800|OTHER||Ratio of GMT|0.56|||||TWO_SIDED|95.0|0.34|0.92|||t-test, 2 sided|||Serotype 19F, Day 30||0.92|0.34|
74043512|NCT03803202|147638800|OTHER||Ratio of GMT|0.64|||||TWO_SIDED|95.0|0.37|1.1|||t-test, 2 sided|||Serotype 19F, Day 30||1.10|0.37|
74043513|NCT03803202|147638800|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.56|1.55|||t-test, 2 sided|||Serotype 19F, Day 30||1.55|0.56|
74043514|NCT03803202|147638800|OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.08|0.46|||t-test, 2 sided|||Serotype 23F, Day 30||0.46|0.08|
74043515|NCT03803202|147638800|OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.08|0.47|||t-test, 2 sided|||Serotype 23F, Day 30||0.47|0.08|
74043516|NCT03803202|147638800|OTHER||Ratio of GMT|0.23|||||TWO_SIDED|95.0|0.09|0.57|||t-test, 2 sided|||Serotype 23F, Day 30||0.57|0.09|
74043517|NCT03803202|147638801|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.52|2.23|||t-test, 2 sided|||Serotype 1, Day 1||2.23|0.52|
74043518|NCT03803202|147638801|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.51|1.98|||t-test, 2 sided|||Serotype 1, Day 1||1.98|0.51|
74043519|NCT03803202|147638801|OTHER||Ratio of GMC|1.43|||||TWO_SIDED|95.0|0.72|2.83|||t-test, 2 sided|||Serotype 1, Day 1||2.83|0.72|
74043520|NCT03803202|147638801|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.59|2.68|||t-test, 2 sided|||Serotype 3, Day 1||2.68|0.59|
74043521|NCT03803202|147638801|OTHER||Ratio of GMC|1.65|||||TWO_SIDED|95.0|0.9|3.05|||t-test, 2 sided|||Serotype 3, Day 1||3.05|0.90|
74043522|NCT03803202|147638801|OTHER||Ratio of GMC|1.24|||||TWO_SIDED|95.0|0.68|2.25|||t-test, 2 sided|||Serotype 3, Day 1||2.25|0.68|
74043523|NCT03803202|147638801|OTHER||Ratio of GMC|1.03|||||TWO_SIDED|95.0|0.49|2.15|||t-test, 2 sided|||Serotype 4, Day 1||2.15|0.49|
74043524|NCT03803202|147638801|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.39|1.74|||t-test, 2 sided|||Serotype 4, Day 1||1.74|0.39|
74043525|NCT03803202|147638801|OTHER||Ratio of GMC|1.24|||||TWO_SIDED|95.0|0.59|2.59|||t-test, 2 sided|||Serotype 4, Day 1||2.59|0.59|
74043526|NCT03803202|147638801|OTHER||Ratio of GMC|1.71|||||TWO_SIDED|95.0|0.75|3.91|||t-test, 2 sided|||Serotype 5, Day 1||3.91|0.75|
74043527|NCT03803202|147638801|OTHER||Ratio of GMC|0.72|||||TWO_SIDED|95.0|0.36|1.46|||t-test, 2 sided|||Serotype 5, Day 1||1.46|0.36|
73880068|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|2.62||||0.1486|TWO_SIDED|95.0|0.71|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.64|0.71|0.1486
73880069|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.51||||0.2881|TWO_SIDED|95.0|0.15|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.77|0.15|0.2881
73880070|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.36||||0.1217|TWO_SIDED|95.0|0.1|1.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.31|0.10|0.1217
73880071|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.36||||0.1027|TWO_SIDED|95.0|0.07|1.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.28|0.07|0.1027
73880072|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.18||||0.0428|TWO_SIDED|95.0|0.03|0.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||0.94|0.03|0.0428
73880073|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5943|TWO_SIDED|95.0|0.21|2.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.44|0.21|0.5943
73880074|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.94||||0.928|TWO_SIDED|95.0|0.27|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.28|0.27|0.9280
73880075|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.94||||0.916|TWO_SIDED|95.0|0.3|2.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.94|0.30|0.9160
73880076|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.43||||0.2262|TWO_SIDED|95.0|0.11|1.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.69|0.11|0.2262
73880077|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2682|TWO_SIDED|95.0|0.13|1.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.75|0.13|0.2682
73880078|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.4||||0.2344|TWO_SIDED|95.0|0.09|1.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.81|0.09|0.2344
73880079|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.22||||0.0835|TWO_SIDED|95.0|0.04|1.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.22|0.04|0.0835
73880080|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.72||||0.6322|TWO_SIDED|95.0|0.19|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.72|0.19|0.6322
73880081|NCT03192176|147297618|SUPERIORITY||Odds Ratio (OR)|0.65||||0.4845|TWO_SIDED|95.0|0.2|2.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.17|0.20|0.4845
73880082|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9587|TWO_SIDED|95.0|0.06|17.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.98|0.06|0.9587
73888023|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|149.1||||0.0011|TWO_SIDED|95.0|60.7|237.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||237.5|60.7|0.0011
74043528|NCT03803202|147638801|OTHER||Ratio of GMC|0.93|||||TWO_SIDED|95.0|0.47|1.84|||t-test, 2 sided|||Serotype 5, Day 1||1.84|0.47|
73880083|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9895|TWO_SIDED|95.0|0.06|16.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.89|0.06|0.9895
73880084|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|7.24||||0.0736|TWO_SIDED|95.0|0.83|63.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||63.32|0.83|0.0736
73880085|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|7.08||||0.0767|TWO_SIDED|95.0|0.81|61.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||61.78|0.81|0.0767
73880086|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|3.51||||0.288|TWO_SIDED|95.0|0.35|35.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||35.49|0.35|0.2880
73880087|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.96||||0.5894|TWO_SIDED|95.0|0.17|22.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.47|0.17|0.5894
73880088|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.45||||0.3093|TWO_SIDED|95.0|0.44|13.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.78|0.44|0.3093
73880089|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|3.31||||0.1606|TWO_SIDED|95.0|0.62|17.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.58|0.62|0.1606
73880090|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|11.92||||0.0019|TWO_SIDED|95.0|2.5|56.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||56.87|2.50|0.0019
73880091|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|14.4||||0.0008|TWO_SIDED|95.0|3.02|68.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||68.73|3.02|0.0008
73880092|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8803|TWO_SIDED|95.0|0.11|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.55|0.11|0.8803
74014230|NCT02706873|147579490|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|4.42|||<|0.001|TWO_SIDED|95.0|3.12|5.72||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.72|3.12|<0.001
73880093|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.98||||0.2096|TWO_SIDED|95.0|0.54|16.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.46|0.54|0.2096
73880094|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|7.69||||0.011|TWO_SIDED|95.0|1.6|37.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||37.11|1.60|0.0110
73880095|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0845|TWO_SIDED|95.0|0.86|11.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.11|0.86|0.0845
74014231|NCT02706873|147579491|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|9.8||||0.002|TWO_SIDED|95.0|3.5|16.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||16.2|3.5|0.002
74014232|NCT02706873|147579491|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|11.6|||<|0.001|TWO_SIDED|95.0|5.4|17.8||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||17.8|5.4|<0.001
74014233|NCT02706873|147579492|SUPERIORITY||Response Rate Difference|18.5|||<|0.001|TWO_SIDED|95.0|12.1|24.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||24.9|12.1|<0.001
74043529|NCT03803202|147638801|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.57|2.52|||t-test, 2 sided|||Serotype 6A, Day 1||2.52|0.57|
74043530|NCT03803202|147638801|OTHER||Ratio of GMC|1.28|||||TWO_SIDED|95.0|0.64|2.56|||t-test, 2 sided|||Serotype 6A, Day 1||2.56|0.64|
74043531|NCT03803202|147638801|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.52|2.28|||t-test, 2 sided|||Serotype 6A, Day 1||2.28|0.52|
74043532|NCT03803202|147638801|OTHER||Ratio of GMC|1.23|||||TWO_SIDED|95.0|0.49|3.09|||t-test, 2 sided|||Serotype 6B, Day 1||3.09|0.49|
74043533|NCT03803202|147638801|OTHER||Ratio of GMC|0.96|||||TWO_SIDED|95.0|0.43|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.43|
74043534|NCT03803202|147638801|OTHER||Ratio of GMC|0.81|||||TWO_SIDED|95.0|0.37|1.73|||t-test, 2 sided|||Serotype 6B, Day 1||1.73|0.37|
74043535|NCT03803202|147638801|OTHER||Ratio of GMC|1.51|||||TWO_SIDED|95.0|0.76|3.01|||t-test, 2 sided|||Serotype 7F, Day 1||3.01|0.76|
74043536|NCT03803202|147638801|OTHER||Ratio of GMC|1.16|||||TWO_SIDED|95.0|0.69|1.94|||t-test, 2 sided|||Serotype 7F, Day 1||1.94|0.69|
74043537|NCT03803202|147638801|OTHER||Ratio of GMC|1.69|||||TWO_SIDED|95.0|0.98|2.91|||t-test, 2 sided|||Serotype 7F, Day 1||2.91|0.98|
74043538|NCT03803202|147638801|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.54|2.22|||t-test, 2 sided|||Serotype 9V, Day 1||2.22|0.54|
74043539|NCT03803202|147638801|OTHER||Ratio of GMC|0.74|||||TWO_SIDED|95.0|0.41|1.36|||t-test, 2 sided|||Serotype 9V, Day 1||1.36|0.41|
74094777|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.876|TWO_SIDED|95.0|-0.58|0.68|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.68|-0.58|0.876
74094778|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49||||0.134|TWO_SIDED|95.0|-0.15|1.13|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.13|-0.15|0.134
74043540|NCT03803202|147638801|OTHER||Ratio of GMC|0.85|||||TWO_SIDED|95.0|0.47|1.55|||t-test, 2 sided|||Serotype 9V, Day 1||1.55|0.47|
74043541|NCT03803202|147638801|OTHER||Ratio of GMC|2.05|||||TWO_SIDED|95.0|0.84|4.99|||t-test, 2 sided|||Serotype 14, Day 1||4.99|0.84|
74043542|NCT03803202|147638801|OTHER||Ratio of GMC|2.6|||||TWO_SIDED|95.0|1.13|5.98|||t-test, 2 sided|||Serotype 14, Day 1||5.98|1.13|
74043543|NCT03803202|147638801|OTHER||Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.37|2.15|||t-test, 2 sided|||Serotype 14, Day 1||2.15|0.37|
74043544|NCT03803202|147638801|OTHER||Ratio of GMC|1.37|||||TWO_SIDED|95.0|0.61|3.06|||t-test, 2 sided|||Serotype 18C, Day 1||3.06|0.61|
74043545|NCT03803202|147638801|OTHER||Ratio of GMC|1.07|||||TWO_SIDED|95.0|0.55|2.09|||t-test, 2 sided|||Serotype 18C, Day 1||2.09|0.55|
74094779|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.011|TWO_SIDED|95.0|0.27|2.07|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.07|0.27|0.011
74094780|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.112|TWO_SIDED|95.0|-0.17|1.64|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.64|-0.17|0.112
74043546|NCT03803202|147638801|OTHER||Ratio of GMC|1.25|||||TWO_SIDED|95.0|0.59|2.65|||t-test, 2 sided|||Serotype 18C, Day 1||2.65|0.59|
74043547|NCT03803202|147638801|OTHER||Ratio of GMC|1.61|||||TWO_SIDED|95.0|0.74|3.49|||t-test, 2 sided|||Serotype 19A, Day 1||3.49|0.74|
74043548|NCT03803202|147638801|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.42|1.65|||t-test, 2 sided|||Serotype 19A, Day 1||1.65|0.42|
74043549|NCT03803202|147638801|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.49|2.05|||t-test, 2 sided|||Serotype 19A, Day 1||2.05|0.49|
74043550|NCT03803202|147638801|OTHER||Ratio of GMC|1.47|||||TWO_SIDED|95.0|0.63|3.39|||t-test, 2 sided|||Serotype 19F, Day 1||3.39|0.63|
74043551|NCT03803202|147638801|OTHER||Ratio of GMC|1.4|||||TWO_SIDED|95.0|0.64|3.07|||t-test, 2 sided|||Serotype 19F, Day 1||3.07|0.64|
74043552|NCT03803202|147638801|OTHER||Ratio of GMC|1.12|||||TWO_SIDED|95.0|0.53|2.34|||t-test, 2 sided|||Serotype 19F, Day 1||2.34|0.53|
74043553|NCT03803202|147638801|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.49|2.09|||t-test, 2 sided|||Serotype 23F, Day 1||2.09|0.49|
74043554|NCT03803202|147638801|OTHER||Ratio of GMC|0.94|||||TWO_SIDED|95.0|0.5|1.75|||t-test, 2 sided|||Serotype 23F, Day 1||1.75|0.50|
74043555|NCT03803202|147638801|OTHER||Ratio of GMC|0.91|||||TWO_SIDED|95.0|0.42|2.0|||t-test, 2 sided|||Serotype 23F, Day 1||2.00|0.42|
74043556|NCT03803202|147638801|OTHER||Ratio of GMC|0.7|||||TWO_SIDED|95.0|0.38|1.29|||t-test, 2 sided|||Serotype 1, Day 30||1.29|0.38|
74043557|NCT03803202|147638801|OTHER||Ratio of GMC|0.95|||||TWO_SIDED|95.0|0.52|1.73|||t-test, 2 sided|||Serotype 1, Day 30||1.73|0.52|
74043558|NCT03803202|147638801|OTHER||Ratio of GMC|1.5|||||TWO_SIDED|95.0|0.84|2.66|||t-test, 2 sided|||Serotype 1, Day 30||2.66|0.84|
74043559|NCT03803202|147638801|OTHER||Ratio of GMC|1.38|||||TWO_SIDED|95.0|0.84|2.28|||t-test, 2 sided|||Serotype 3, Day 30||2.28|0.84|
74043560|NCT03803202|147638801|OTHER||Ratio of GMC|2.68|||||TWO_SIDED|95.0|1.71|4.19|||t-test, 2 sided|||Serotype 3, Day 30||4.19|1.71|
74043561|NCT03803202|147638801|OTHER||Ratio of GMC|3.87|||||TWO_SIDED|95.0|2.47|6.06|||t-test, 2 sided|||Serotype 3, Day 30||6.06|2.47|
74043562|NCT03803202|147638801|OTHER||Ratio of GMC|1.27|||||TWO_SIDED|95.0|0.7|2.3|||t-test, 2 sided|||Serotype 4, Day 30||2.30|0.70|
74043563|NCT03803202|147638801|OTHER||Ratio of GMC|1.02|||||TWO_SIDED|95.0|0.57|1.81|||t-test, 2 sided|||Serotype 4, Day 30||1.81|0.57|
74043564|NCT03803202|147638801|OTHER||Ratio of GMC|2.24|||||TWO_SIDED|95.0|1.21|4.15|||t-test, 2 sided|||Serotype 4, Day 30||4.15|1.21|
74043565|NCT03803202|147638801|OTHER||Ratio of GMC|1.58|||||TWO_SIDED|95.0|0.7|3.57|||t-test, 2 sided|||Serotype 5, Day 30||3.57|0.70|
74043566|NCT03803202|147638801|OTHER||Ratio of GMC|0.84|||||TWO_SIDED|95.0|0.35|2.05|||t-test, 2 sided|||Serotype 5, Day 30||2.05|0.35|
74094781|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.179|TWO_SIDED|95.0|-0.2|1.08|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.08|-0.20|0.179
74014234|NCT02706873|147579492|OTHER||Response Rate Difference|22.9|||<|0.001|TWO_SIDED|95.0|16.4|29.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||29.5|16.4|<0.001
74014235|NCT02706873|147579493|SUPERIORITY||Response Rate Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.2|27.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||27.3|13.2|<0.001
74014236|NCT02706873|147579493|SUPERIORITY||Response Rate Difference|19.4|||<|0.001|TWO_SIDED|95.0|12.3|26.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||26.5|12.3|<0.001
74014237|NCT02706873|147579494|SUPERIORITY||Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|19.1|33.0||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||33.0|19.1|<0.001
74014238|NCT02706873|147579494|SUPERIORITY||Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|24.2|38.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||38.2|24.2|<0.001
74014239|NCT02706873|147579495|SUPERIORITY|For the Japan sub-study, no multiplicity adjustments were applied and only nominal p-values were provided for all efficacy analyses.|Response Rate Difference|28.3||||0.004|TWO_SIDED|95.0|7.7|48.9|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||48.9|7.7|0.004
74014240|NCT02706873|147579495|SUPERIORITY||Response Rate Difference|28.0||||0.022|TWO_SIDED|95.0|5.3|50.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||50.7|5.3|0.022
74014241|NCT02706873|147579495|SUPERIORITY||Response Rate Difference|21.4||||0.086|TWO_SIDED|95.0|-2.4|45.2|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||45.2|-2.4|0.086
74043567|NCT03803202|147638801|OTHER||Ratio of GMC|1.49|||||TWO_SIDED|95.0|0.65|3.39|||t-test, 2 sided|||Serotype 5, Day 30||3.39|0.65|
74043568|NCT03803202|147638801|OTHER||Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.41|1.93|||t-test, 2 sided|||Serotype 6A, Day 30||1.93|0.41|
74094782|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97||||0.032|TWO_SIDED|95.0|0.09|1.85|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.85|0.09|0.032
74094783|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.85|TWO_SIDED|95.0|-0.56|0.67|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.67|-0.56|0.850
74014242|NCT02706873|147579496|SUPERIORITY||Response Rate Difference|38.6|||<|0.001|TWO_SIDED|95.0|18.6|58.5|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.5|18.6|<0.001
74014243|NCT02706873|147579496|SUPERIORITY||Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|21.8|68.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||68.6|21.8|<0.001
74014244|NCT02706873|147579496|SUPERIORITY||Response Rate Difference|50.0|||<|0.001|TWO_SIDED|95.0|27.4|72.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||72.6|27.4|<0.001
74014245|NCT02706873|147579497|SUPERIORITY||Response Rate Difference|34.5|||<|0.001|TWO_SIDED|95.0|22.0|47.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||47.1|22.0|<0.001
74014246|NCT02706873|147579497|SUPERIORITY||Response Rate Difference|51.9|||<|0.001|TWO_SIDED|95.0|33.0|70.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||70.7|33.0|<0.001
74014247|NCT02706873|147579497|SUPERIORITY||Response Rate Difference|64.3|||<|0.001|TWO_SIDED|95.0|46.5|82.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||82.0|46.5|<0.001
74094784|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.311|TWO_SIDED|95.0|-0.3|0.95|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.95|-0.30|0.311
74014248|NCT02706873|147579498|SUPERIORITY||LS Mean Difference|-1.43|||<|0.001|TWO_SIDED|95.0|-1.92|-0.95|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.95|-1.92|<0.001
74014249|NCT02706873|147579498|SUPERIORITY||LS Mean Difference|-1.86|||<|0.001|TWO_SIDED|95.0|-2.42|-1.3|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-1.30|-2.42|<0.001
74014250|NCT02706873|147579498|SUPERIORITY||LS Mean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.48|-1.36|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-1.36|-2.48|<0.001
74043569|NCT03803202|147638801|OTHER||Ratio of GMC|0.77|||||TWO_SIDED|95.0|0.33|1.79|||t-test, 2 sided|||Serotype 6A, Day 30||1.79|0.33|
74043570|NCT03803202|147638801|OTHER||Ratio of GMC|0.69|||||TWO_SIDED|95.0|0.32|1.48|||t-test, 2 sided|||Serotype 6A, Day 30||1.48|0.32|
74043571|NCT03803202|147638801|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.57|2.83|||t-test, 2 sided|||Serotype 6B, Day 30||2.83|0.57|
74043572|NCT03803202|147638801|OTHER||Ratio of GMC|0.75|||||TWO_SIDED|95.0|0.31|1.81|||t-test, 2 sided|||Serotype 6B, Day 30||1.81|0.31|
74043573|NCT03803202|147638801|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.39|1.97|||t-test, 2 sided|||Serotype 6B, Day 30||1.97|0.39|
74094785|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.043|TWO_SIDED|95.0|0.03|1.79|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.79|0.03|0.043
74014251|NCT02706873|147579499|SUPERIORITY||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.34|-0.75|<0.001
74014252|NCT02706873|147579499|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.51|-0.99|<0.001
74014253|NCT02706873|147579499|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.51|-0.99|<0.001
74014254|NCT02706873|147579500|SUPERIORITY||LS Mean Difference|5.97|||<|0.001|TWO_SIDED|95.0|3.15|8.8|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||8.80|3.15|<0.001
74014255|NCT02706873|147579500|SUPERIORITY||LS Mean Difference|7.92|||<|0.001|TWO_SIDED|95.0|4.66|11.19|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||11.19|4.66|<0.001
74014256|NCT02706873|147579500|SUPERIORITY||LS Mean Difference|6.76|||<|0.001|TWO_SIDED|95.0|3.33|10.2|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||10.20|3.33|<0.001
74014257|NCT02706873|147579501|SUPERIORITY||Response Rate Difference|51.2|||<|0.001|TWO_SIDED|95.0|32.5|70.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||70.0|32.5|<0.001
74014258|NCT02706873|147579501|SUPERIORITY||Response Rate Difference|59.9|||<|0.001|TWO_SIDED|95.0|38.8|81.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||81.1|38.8|<0.001
74014259|NCT02706873|147579501|SUPERIORITY||Response Rate Difference|60.7|||<|0.001|TWO_SIDED|95.0|39.9|81.5|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||81.5|39.9|<0.001
74014260|NCT02706873|147579502|SUPERIORITY||Response Rate Difference|49.4|||<|0.001|TWO_SIDED|95.0|30.6|68.3|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||68.3|30.6|<0.001
74014261|NCT02706873|147579502|SUPERIORITY||Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|30.2|74.8|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||74.8|30.2|<0.001
74014262|NCT02706873|147579502|SUPERIORITY||Response Rate Difference|64.3|||<|0.001|TWO_SIDED|95.0|44.2|84.3|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||84.3|44.2|<0.001
74014263|NCT02706873|147579503|SUPERIORITY||LS Mean Difference|-1.69||||0.063|TWO_SIDED|95.0|-3.47|0.09|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||0.09|-3.47|0.063
74014264|NCT02706873|147579503|SUPERIORITY||LS Mean Difference|-2.4||||0.022|TWO_SIDED|95.0|-4.45|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.35|-4.45|0.022
74014265|NCT02706873|147579503|SUPERIORITY||LS Mean Difference|-2.45||||0.022|TWO_SIDED|95.0|-4.54|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.35|-4.54|0.022
74014266|NCT02706873|147579504|SUPERIORITY||Response Rate Difference|36.2||||0.001|TWO_SIDED|95.0|14.4|58.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.0|14.4|0.001
74014267|NCT02706873|147579504|SUPERIORITY||Response Rate Difference|34.6||||0.01|TWO_SIDED|95.0|10.2|59.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||59.0|10.2|0.010
74014268|NCT02706873|147579504|SUPERIORITY||Response Rate Difference|33.0||||0.016|TWO_SIDED|95.0|7.9|58.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.1|7.9|0.016
74014269|NCT05051904|147579505|OTHER||Adjusted Hazard Ratio|0.5|||<|0.0001|TWO_SIDED|95.0|0.402|0.622|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.622|0.402|<0.0001
74014270|NCT05051904|147579505|OTHER||Adjusted Hazard Ratio|0.784||||0.0004|TWO_SIDED|95.0|0.686|0.896|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Rivaroxaban.|||0.896|0.686|0.0004
74014271|NCT05051904|147579505|OTHER||Adjusted Hazard Ratio|0.637|||<|0.0001|TWO_SIDED|95.0|0.514|0.791|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.791|0.514|<0.0001
74014272|NCT05051904|147579506|OTHER||Adjusted Hazard Ratio|0.78|||<|0.0001|TWO_SIDED|95.0|0.714|0.851|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.851|0.714|<0.0001
74014273|NCT05051904|147579506|OTHER||Adjusted Hazard Ratio|0.827|||<|0.0001|TWO_SIDED|95.0|0.777|0.88|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio\<1 favors Rivaroxaban|||0.88|0.777|<0.0001
74014274|NCT00794677|147579528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.252|STANDARD_ERROR_OF_MEAN|0.112||0.03||95.0|||||ANOVA|||Statistical significance was determined for a standard two-period crossover design using JMP software (Version 5.0, SAS Institute. Cary, NC).||||0.03
74014275|NCT00794677|147579529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.273|STANDARD_ERROR_OF_MEAN|0.102||0.01||95.0|||||ANOVA|||||||0.01
74014276|NCT00794677|147579530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.089||0.6||95.0|||||ANOVA|||||||0.60
74014277|NCT00794677|147579531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.47||0.67||95.0|||||ANOVA|||||||0.67
74014278|NCT00794677|147579532|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.14||0.3||95.0|||||ANOVA|||||||0.30
74014279|NCT00794677|147579533|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.412|STANDARD_ERROR_OF_MEAN|1.569|<|0.0001|TWO_SIDED|95.0|||||ANOVA|||||||<0.0001
74014280|NCT00794677|147579534|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.846|STANDARD_ERROR_OF_MEAN|2.866|<|1e-07|TWO_SIDED|95.0|||||ANOVA|||||||<0.0000001
74014281|NCT00794677|147579535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.397|STANDARD_ERROR_OF_MEAN|1.893||0.009|TWO_SIDED|95.0|||||ANOVA|||||||0.009
74094786|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.154||95.0|-0.24|1.53|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.53|-0.24|0.154
74094787|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.408|TWO_SIDED|95.0|-0.36|0.89|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.89|-0.36|0.408
74094788|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.065|TWO_SIDED|95.0|-0.05|1.68|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.68|-0.05|0.065
74094789|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.862|TWO_SIDED|95.0|-0.66|0.55|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.55|-0.66|0.862
74094790|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.352|TWO_SIDED|95.0|-0.32|0.9|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.90|-0.32|0.352
74094791|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.87||||0.049|TWO_SIDED|95.0|0.0|1.73|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.73|0.00|0.049
73880096|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1094|TWO_SIDED|95.0|0.79|10.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.13|0.79|0.1094
74014282|NCT00794677|147579536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.353|STANDARD_ERROR_OF_MEAN|2.22|<|1e-07|TWO_SIDED|95.0|||||ANOVA|||||||<0.0000001
74014283|NCT02692495|147579554|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
74094792|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.239|TWO_SIDED|95.0|-0.35|1.39|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.39|-0.35|0.239
74094793|NCT02912650|147740349|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.27|TWO_SIDED|95.0|-0.27|0.96|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.96|-0.27|0.270
74094794|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.031|TWO_SIDED|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|0.01|0.031
74094795|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.527|TWO_SIDED|95.0|-0.06|0.12|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.12|-0.06|0.527
74094796|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.386|TWO_SIDED|95.0|-0.14|0.05|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.05|-0.14|0.386
74094797|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.084|TWO_SIDED|95.0|-0.02|0.25|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.25|-0.02|0.084
74094798|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.006|TWO_SIDED|95.0|0.06|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|0.06|0.006
74094799|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.135|TWO_SIDED|95.0|-0.17|0.02|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.02|-0.17|0.135
74094800|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|||<|0.001|TWO_SIDED|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.34|<0.001
74094801|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.062|TWO_SIDED|95.0|-0.01|0.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.27|-0.01|0.062
74094802|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.977|TWO_SIDED|95.0|-0.14|0.14|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.14|-0.14|0.977
74094803|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.6|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.60|0.21|<0.001
74094804|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|||<|0.001|TWO_SIDED|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.34|<0.001
74014284|NCT02249143|147579560|SUPERIORITY||Mean Difference (Net)|6.62|||<|0.05|TWO_SIDED|95.0|0.02|13.22|||Regression, Linear|||FRC values over time were modeled using linear mixed effects regression with treatment group vs. time interaction and repeated measures for the randomization, 2 week, and discharge time points. Compound symmetric covariance structures were used to account for the correlation of FRC values within each patient. We compared outcomes between the two treatment groups and included adjustments for gender, twin gestation, and weight at randomization.||13.22|0.02|<0.05
74014285|NCT02249143|147579561|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
74094805|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.069|TWO_SIDED|95.0|-0.27|0.01|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.01|-0.27|0.069
74094806|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|1.14|||<|0.001|TWO_SIDED|95.0|0.9|1.38|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.90|<0.001
74094807|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|||<|0.001|TWO_SIDED|95.0|0.12|0.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.46|0.12|<0.001
74094808|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.011|TWO_SIDED|95.0|0.05|0.39|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.39|0.05|0.011
74094809|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.85|||<|0.001|TWO_SIDED|95.0|0.61|1.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.61|< 0.001
74094810|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|||<|0.001|TWO_SIDED|95.0|0.67|1.16|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.16|0.67|<0.001
74094811|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.427|TWO_SIDED|95.0|-0.24|0.1|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.10|-0.24|0.427
74094812|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|||<|0.001|TWO_SIDED|95.0|1.11|1.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.60|1.11|<0.001
74094813|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.002|TWO_SIDED|95.0|0.1|0.44|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|0.10|0.002
74094814|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.23|0.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.58|0.23|<0.001
74094815|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.84|1.33|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.33|0.84|<0.001
74094816|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.95|||<|0.001|TWO_SIDED|95.0|0.7|1.2|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.70|<0.001
74094817|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.123|TWO_SIDED|95.0|-0.04|0.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.31|-0.04|0.123
74094818|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|||<|0.001|TWO_SIDED|95.0|1.14|1.67|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.67|1.14|<0.001
74014286|NCT02249143|147579561|SUPERIORITY|||||||||||||||||Group differences in the secondary outcomes were tested at randomization, two weeks, and discharge using independent samples t-tests.||||
74014287|NCT01783080|147579573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4||||0.005|TWO_SIDED||||||Regression, Linear|||||||0.005
74094819|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.012|TWO_SIDED|95.0|0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|0.05|0.012
74094820|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.38|0.75|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.75|0.38|<0.001
74094821|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|||<|0.001|TWO_SIDED|95.0|0.9|1.43|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.90|<0.001
74094822|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84|||<|0.001|TWO_SIDED|95.0|0.57|1.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.11|0.57|<0.001
74094823|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.14|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|0.14|<0.001
74094824|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|||<|0.001|TWO_SIDED|95.0|1.11|1.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.65|1.11|<0.001
74094825|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.002|TWO_SIDED|95.0|0.11|0.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.48|0.11|0.002
74014288|NCT01783080|147579575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.11|TWO_SIDED||||||Regression, Linear|||||||0.11
74014289|NCT03817775|147579598|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74014290|NCT03817775|147579599|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74043574|NCT03803202|147638801|OTHER||Ratio of GMC|1.86|||||TWO_SIDED|95.0|1.05|3.3|||t-test, 2 sided|||Serotype 7F, Day 30||3.30|1.05|
74043575|NCT03803202|147638801|OTHER||Ratio of GMC|1.98|||||TWO_SIDED|95.0|1.1|3.55|||t-test, 2 sided|||Serotype 7F, Day 30||3.55|1.10|
74043576|NCT03803202|147638801|OTHER||Ratio of GMC|2.88|||||TWO_SIDED|95.0|1.62|5.12|||t-test, 2 sided|||Serotype 7F, Day 30||5.12|1.62|
74043577|NCT03803202|147638801|OTHER||Ratio of GMC|0.96|||||TWO_SIDED|95.0|0.49|1.87|||t-test, 2 sided|||Serotype 9V, Day 30||1.87|0.49|
74043578|NCT03803202|147638801|OTHER||Ratio of GMC|1.39|||||TWO_SIDED|95.0|0.74|2.62|||t-test, 2 sided|||Serotype 9V, Day 30||2.62|0.74|
74043579|NCT03803202|147638801|OTHER||Ratio of GMC|1.68|||||TWO_SIDED|95.0|0.87|3.27|||t-test, 2 sided|||Serotype 9V, Day 30||3.27|0.87|
74043580|NCT03803202|147638801|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.41|2.53|||t-test, 2 sided|||Serotype 14, Day 30||2.53|0.41|
74043581|NCT03803202|147638801|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.45|2.6|||t-test, 2 sided|||Serotype 14, Day 30||2.60|0.45|
74043582|NCT03803202|147638801|OTHER||Ratio of GMC|2.09|||||TWO_SIDED|95.0|0.86|5.04|||t-test, 2 sided|||Serotype 14, Day 30||5.04|0.86|
74043583|NCT03803202|147638801|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.57|2.07|||t-test, 2 sided|||Serotype 18C, Day 30||2.07|0.57|
74043584|NCT03803202|147638801|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.53|1.89|||t-test, 2 sided|||Serotype 18C, Day 30||1.89|0.53|
73880097|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|8.97||||0.0004|TWO_SIDED|95.0|2.68|30.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||30.07|2.68|0.0004
74014291|NCT03817775|147579600|OTHER|||||||0.7215|||||||Wilcoxon (Mann-Whitney)|||||||0.7215
74014292|NCT03817775|147579601|OTHER|||||||0.5675|||||||Wilcoxon (Mann-Whitney)|||||||0.5675
74014293|NCT03817775|147579602|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74014294|NCT00531752|147579625|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.7947|STANDARD_ERROR_OF_MEAN|1.8848||0.6749|TWO_SIDED|80.0|-1.649|3.2383||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.2383|-1.649|0.6749
74043585|NCT03803202|147638801|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.56|2.07|||t-test, 2 sided|||Serotype 18C, Day 30||2.07|0.56|
74043586|NCT03803202|147638801|OTHER||Ratio of GMC|0.68|||||TWO_SIDED|95.0|0.4|1.14|||t-test, 2 sided|||Serotype 19A, Day 30||1.14|0.40|
74043587|NCT03803202|147638801|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.46|1.61|||t-test, 2 sided|||Serotype 19A, Day 30||1.61|0.46|
74043588|NCT03803202|147638801|OTHER||Ratio of GMC|0.87|||||TWO_SIDED|95.0|0.47|1.6|||t-test, 2 sided|||Serotype 19A, Day 30||1.60|0.47|
74043589|NCT03803202|147638801|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.49|2.01|||t-test, 2 sided|||Serotype 19F, Day 30||2.01|0.49|
74043590|NCT03803202|147638801|OTHER||Ratio of GMC|1.38|||||TWO_SIDED|95.0|0.75|2.53|||t-test, 2 sided|||Serotype 19F, Day 30||2.53|0.75|
74043591|NCT03803202|147638801|OTHER||Ratio of GMC|1.41|||||TWO_SIDED|95.0|0.68|2.96|||t-test, 2 sided|||Serotype 19F, Day 30||2.96|0.68|
74043592|NCT03803202|147638801|OTHER||Ratio of GMC|0.46|||||TWO_SIDED|95.0|0.2|1.07|||t-test, 2 sided|||Serotype 23F, Day 30||1.07|0.20|
74043593|NCT03803202|147638801|OTHER||Ratio of GMC|0.5|||||TWO_SIDED|95.0|0.22|1.11|||t-test, 2 sided|||Serotype 23F, Day 30||1.11|0.22|
74043594|NCT03803202|147638801|OTHER||Ratio of GMC|0.64|||||TWO_SIDED|95.0|0.29|1.44|||t-test, 2 sided|||Serotype 23F, Day 30||1.44|0.29|
74043595|NCT03803202|147638805|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.56|1.14|||t-test, 2 sided|||Serotype 1, Day 1||1.14|0.56|
74043596|NCT03803202|147638805|OTHER||Ratio of GMT|1.39|||||TWO_SIDED|95.0|0.89|2.16|||t-test, 2 sided|||Serotype 1, Day 1||2.16|0.89|
74043597|NCT03803202|147638805|OTHER||Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.51|1.06|||t-test, 2 sided|||Serotype 1, Day 1||1.06|0.51|
74043598|NCT03803202|147638805|OTHER||Ratio of GMT|1.33|||||TWO_SIDED|95.0|0.85|2.09|||t-test, 2 sided|||Serotype 3, Day 1||2.09|0.85|
74043599|NCT03803202|147638805|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.91|2.3|||t-test, 2 sided|||Serotype 3, Day 1||2.30|0.91|
74043600|NCT03803202|147638805|OTHER||Ratio of GMT|0.95|||||TWO_SIDED|95.0|0.6|1.49|||t-test, 2 sided|||Serotype 3, Day 1||1.49|0.60|
74043601|NCT03803202|147638805|OTHER||Ratio of GMT|0.81|||||TWO_SIDED|95.0|0.46|1.4|||t-test, 2 sided|||Serotype 4, Day 1||1.40|0.46|
74043602|NCT03803202|147638805|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.62|1.91|||t-test, 2 sided|||Serotype 4, Day 1||1.91|0.62|
74043603|NCT03803202|147638805|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.4|1.23|||t-test, 2 sided|||Serotype 4, Day 1||1.23|0.40|
74043604|NCT03803202|147638805|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.58|1.68|||t-test, 2 sided|||Serotype 5, Day 1||1.68|0.58|
74043605|NCT03803202|147638805|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.76|2.29|||t-test, 2 sided|||Serotype 5, Day 1||2.29|0.76|
74043606|NCT03803202|147638805|OTHER||Ratio of GMT|0.88|||||TWO_SIDED|95.0|0.51|1.53|||t-test, 2 sided|||Serotype 5, Day 1||1.53|0.51|
74043607|NCT03803202|147638805|OTHER||Ratio of GMT|0.96|||||TWO_SIDED|95.0|0.54|1.72|||t-test, 2 sided|||Serotype 6A, Day 1||1.72|0.54|
74043608|NCT03803202|147638805|OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.57|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.57|
74043609|NCT03803202|147638805|OTHER||Ratio of GMT|1.63|||||TWO_SIDED|95.0|0.86|3.1|||t-test, 2 sided|||Serotype 6A, Day 1||3.10|0.86|
74043610|NCT03803202|147638805|OTHER||Ratio of GMT|1.61|||||TWO_SIDED|95.0|0.83|3.14|||t-test, 2 sided|||Serotype 6A, Day 1||3.14|0.83|
74014295|NCT00531752|147579625|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4176|STANDARD_ERROR_OF_MEAN|2.0343||0.4886|TWO_SIDED|80.0|-1.218|4.0533||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.0533|-1.218|0.4886
74014296|NCT00531752|147579626|SUPERIORITY_OR_OTHER||LS Mean Difference|1.025|STANDARD_ERROR_OF_MEAN|1.7713||0.5643|TWO_SIDED|80.0|-1.262|3.3121|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3121|-1.262|0.5643
74014297|NCT00531752|147579626|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9146|STANDARD_ERROR_OF_MEAN|1.8777||0.3107|TWO_SIDED|80.0|-0.51|4.3392|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.3392|-0.5100|0.3107
74043611|NCT03803202|147638805|OTHER||Ratio of GMT|1.15|||||TWO_SIDED|95.0|0.59|2.24|||t-test, 2 sided|||Serotype 6B, Day 1||2.24|0.59|
74043612|NCT03803202|147638805|OTHER||Ratio of GMT|1.18|||||TWO_SIDED|95.0|0.58|2.39|||t-test, 2 sided|||Serotype 6B, Day 1||2.39|0.58|
74043613|NCT03803202|147638805|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.4|1.8|||t-test, 2 sided|||Serotype 7F, Day 1||1.80|0.40|
74014298|NCT00531752|147579626|SUPERIORITY_OR_OTHER||LS Mean Difference|2.3154|STANDARD_ERROR_OF_MEAN|1.4638||0.1196|TWO_SIDED|80.0|0.41601|4.2148|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2148|0.41601|0.1196
74014299|NCT00531752|147579626|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3288|STANDARD_ERROR_OF_MEAN|1.524||0.3872|TWO_SIDED|80.0|-0.649|3.3065|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3065|-0.6490|0.3872
74043614|NCT03803202|147638805|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.63|2.87|||t-test, 2 sided|||Serotype 7F, Day 1||2.87|0.63|
74043615|NCT03803202|147638805|OTHER||Ratio of GMT|1.03|||||TWO_SIDED|95.0|0.45|2.37|||t-test, 2 sided|||Serotype 7F, Day 1||2.37|0.45|
74043616|NCT03803202|147638805|OTHER||Ratio of GMT|0.65||||||95.0|0.32|1.32|||t-test, 2 sided|||Serotype 9V, Day 1||1.32|0.32|
74043617|NCT03803202|147638805|OTHER||Ratio of GMT|0.78|||||TWO_SIDED|95.0|0.37|1.64|||t-test, 2 sided|||Serotype 9V, Day 1||1.64|0.37|
74043618|NCT03803202|147638805|OTHER||Ratio of GMT|0.66|||||TWO_SIDED|95.0|0.3|1.49|||t-test, 2 sided|||Serotype 9V, Day 1||1.49|0.30|
74043619|NCT03803202|147638805|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.31|1.18|||t-test, 1 sided|||Serotype 14, Day 1||1.18|0.31|
74014300|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1677|STANDARD_ERROR_OF_MEAN|1.0269||0.8708|TWO_SIDED|80.0|-1.162|1.4971|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.4971|-1.162|0.8708
74014301|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8607|STANDARD_ERROR_OF_MEAN|1.0912||0.0927|TWO_SIDED|80.0|0.44874|3.2726|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.2726|0.44874|0.0927
74043620|NCT03803202|147638805|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.54|2.18|||t-test, 2 sided|||Serotype 14, Day 1||2.18|0.54|
74043621|NCT03803202|147638805|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.66|2.65|||t-test, 2 sided|||Serotype 14, Day 1||2.65|0.66|
74043622|NCT03803202|147638805|OTHER||Ratio of GMT|0.54|||||TWO_SIDED|95.0|0.3|0.95|||t-test, 2 sided|||Serotype 18C, Day 1||0.95|0.30|
74043623|NCT03803202|147638805|OTHER||Ratio of GMT|1.37|||||TWO_SIDED|95.0|0.73|2.57|||t-test, 2 sided|||Serotype 18C, Day 1||2.57|0.73|
74043624|NCT03803202|147638805|OTHER||Ratio of GMT|0.58|||||TWO_SIDED|95.0|0.32|1.04|||t-test, 2 sided|||Serotype 18C, Day 1||1.04|0.32|
74043625|NCT03803202|147638805|OTHER||Ratio of GMT|0.76|||||TWO_SIDED|95.0|0.44|1.32|||t-test, 2 sided|||Serotype 19A, Day 1||1.32|0.44|
74043626|NCT03803202|147638805|OTHER||Ratio of GMT|1.15|||||TWO_SIDED|95.0|0.66|2.01|||t-test, 2 sided|||Serotype 19A, Day 1||2.01|0.66|
74043627|NCT03803202|147638805|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.48|1.5|||t-test, 2 sided|||Serotype 19A, Day 1||1.50|0.48|
74043628|NCT03803202|147638805|OTHER||Ratio of GMT|0.79|||||TWO_SIDED|95.0|0.45|1.38|||t-test, 2 sided|||Serotype 19F, Day 1||1.38|0.45|
74043629|NCT03803202|147638805|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.47|1.52|||t-test, 2 sided|||Serotype 19F, Day 1||1.52|0.47|
74043630|NCT03803202|147638805|OTHER||Ratio of GMT|0.62|||||TWO_SIDED|95.0|0.34|1.12|||t-test, 2 sided|||Serotype 19F, Day 1||1.12|0.34|
74043631|NCT03803202|147638805|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.64|1.94|||t-test, 2 sided|||Serotype 23F, Day 1||1.94|0.64|
74043632|NCT03803202|147638805|OTHER||Ratio of GMT|1.37|||||TWO_SIDED|95.0|0.77|2.42|||t-test, 2 sided|||Serotype 23F, Day 1||2.42|0.77|
74043633|NCT03803202|147638805|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.66|2.14|||t-test, 2 sided|||Serotype 23F, Day 1||2.14|0.66|
74043634|NCT03803202|147638805|OTHER||Ratio of GMT|0.83|||||TWO_SIDED|95.0|0.47|1.47|||t-test, 2 sided|||Serotype 1, Day 30||1.47|0.47|
74043635|NCT03803202|147638805|OTHER||Ratio of GMT|0.87|||||TWO_SIDED|95.0|0.5|1.53|||t-test, 2 sided|||Serotype 1, Day 30||1.53|0.50|
74043636|NCT03803202|147638805|OTHER||Ratio of GMT|1.28|||||TWO_SIDED|95.0|0.74|2.2|||t-test, 2 sided|||Serotype 1, Day 30||2.20|0.74|
74043637|NCT03803202|147638805|OTHER||Ratio of GMT|25.03|||||TWO_SIDED|95.0|16.33|38.34|||t-test, 2 sided|||Serotype 2, Day 30||38.34|16.33|
74043638|NCT03803202|147638805|OTHER||Ratio of GMT|21.99|||||TWO_SIDED|95.0|14.31|33.77|||t-test, 2 sided|||Serotype 2, Day 30||33.77|14.31|
74043639|NCT03803202|147638805|OTHER||Ratio of GMT|35.38|||||TWO_SIDED|95.0|23.09|54.22|||t-test, 2 sided|||Serotype 2, Day 30||54.22|23.09|
74043640|NCT03803202|147638805|OTHER||Ratio of GMT|1.81|||||TWO_SIDED|95.0|1.25|2.62|||t-test, 2 sided|||Serotype 3, Day 30||2.62|1.25|
74043641|NCT03803202|147638805|OTHER||Ratio of GMT|2.55|||||TWO_SIDED|95.0|1.83|3.56|||t-test, 2 sided|||Serotype 3, Day 30||3.56|1.83|
73880098|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0016|TWO_SIDED|95.0|2.1|24.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||24.09|2.10|0.0016
73880099|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4375|TWO_SIDED|95.0|0.44|6.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.64|0.44|0.4375
73880100|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|3.02||||0.0898|TWO_SIDED|95.0|0.84|10.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.85|0.84|0.0898
73880101|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|6.32||||0.0027|TWO_SIDED|95.0|1.9|21.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.06|1.90|0.0027
73880102|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1242|TWO_SIDED|95.0|0.78|7.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.64|0.78|0.1242
73880103|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0815|TWO_SIDED|95.0|0.88|8.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.03|0.88|0.0815
73880104|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|6.21||||0.0009|TWO_SIDED|95.0|2.11|18.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.27|2.11|0.0009
73880105|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0027|TWO_SIDED|95.0|1.78|15.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||15.64|1.78|0.0027
73880106|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.35||||0.6267|TWO_SIDED|95.0|0.41|4.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.46|0.41|0.6267
74014302|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|0.866|STANDARD_ERROR_OF_MEAN|0.9037||0.3405|TWO_SIDED|80.0|-0.3008|2.0329|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.0329|-0.3008|0.3405
74014303|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1623|STANDARD_ERROR_OF_MEAN|0.9622||0.8665|TWO_SIDED|80.0|-1.08|1.4047|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.4047|-1.080|0.8665
74043642|NCT03803202|147638805|OTHER||Ratio of GMT|3.14|||||TWO_SIDED|95.0|2.2|4.48|||t-test, 2 sided|||Serotype 3, Day 30||4.48|2.20|
74043643|NCT03803202|147638805|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.59|1.62|||t-test, 2 sided|||Serotype 4, Day 30||1.62|0.59|
73880107|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0709|TWO_SIDED|95.0|0.92|8.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.38|0.92|0.0709
73880108|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|4.62||||0.0049|TWO_SIDED|95.0|1.59|13.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.59|1.59|0.0049
74014304|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3886|STANDARD_ERROR_OF_MEAN|0.9694||0.6901|TWO_SIDED|80.0|-0.8694|1.6466|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.6466|-0.8694|0.6901
74043644|NCT03803202|147638805|OTHER||Ratio of GMT|0.94|||||TWO_SIDED|95.0|0.59|1.51|||t-test, 2 sided|||Serotype 4, Day 30||1.51|0.59|
74043645|NCT03803202|147638805|OTHER||Ratio of GMT|1.23|||||TWO_SIDED|95.0|0.76|1.99|||t-test, 2 sided|||Serotype 4, Day 30||1.99|0.76|
74043646|NCT03803202|147638805|OTHER||Ratio of GMT|1.25|||||TWO_SIDED|95.0|0.71|2.21|||t-test, 2 sided|||Serotype 5, Day 30||2.21|0.71|
74043647|NCT03803202|147638805|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.85|2.46|||t-test, 2 sided|||Serotype 5, Day 30||2.46|0.85|
74043648|NCT03803202|147638805|OTHER||Ratio of GMT|2.15|||||TWO_SIDED|95.0|1.25|3.72|||t-test, 2 sided|||Serotype 5, Day 30||3.72|1.25|
74043649|NCT03803202|147638805|OTHER||Ratio of GMT|0.94|||||TWO_SIDED|95.0|0.59|1.51|||t-test, 2 sided|||Serotype 6B, Day 30||1.51|0.59|
74043650|NCT03803202|147638805|OTHER||Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.56|1.29|||t-test, 2 sided|||Serotype 6B, Day 30||1.29|0.56|
74043651|NCT03803202|147638805|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.54|1.3|||t-test, 2 sided|||Serotype 6B, Day 30||1.30|0.54|
74043652|NCT03803202|147638805|OTHER||Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.61|1.18|||t-test, 2 sided|||Serotype 7F, Day 30||1.18|0.61|
74043653|NCT03803202|147638805|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.65|1.21|||t-test, 2 sided|||Serotype 7F, Day 30||1.21|0.65|
74043654|NCT03803202|147638805|OTHER||Ratio of GMT|1.05|||||TWO_SIDED|95.0|0.73|1.5|||t-test, 2 sided|||Serotype 7F, Day 30||1.50|0.73|
74043655|NCT03803202|147638805|OTHER||Ratio of GMT|19.46|||||TWO_SIDED|95.0|12.26|30.87|||t-test, 2 sided|||Serotype 8, Day 30||30.87|12.26|
74043656|NCT03803202|147638805|OTHER||Ratio of GMT|19.65|||||TWO_SIDED|95.0|12.07|32.0|||t-test, 2 sided|||Serotype 8, Day 30||32.00|12.07|
74043657|NCT03803202|147638805|OTHER||Ratio of GMT|41.87|||||TWO_SIDED|95.0|26.2|66.9|||t-test, 2 sided|||Serotype 8, Day 30||66.90|26.20|
74043658|NCT03803202|147638805|OTHER||Ratio of GMT|4.75|||||TWO_SIDED|95.0|3.06|7.36|||t-test, 2 sided|||Serotype 9N, Day 30||7.36|3.06|
74043659|NCT03803202|147638805|OTHER||Ratio of GMT|5.66|||||TWO_SIDED|95.0|3.83|8.37|||t-test, 2 sided|||Serotype 9N, Day 30||8.37|3.83|
74043660|NCT03803202|147638805|OTHER||Ratio of GMT|7.84|||||TWO_SIDED|95.0|5.19|11.82|||t-test, 2 sided|||Serotype 9N, Day 30||11.82|5.19|
74043661|NCT03803202|147638805|OTHER||Ratio of GMT|0.83|||||TWO_SIDED|95.0|0.49|1.42|||t-test, 2 sided|||Serotype 9V, Day 30||1.42|0.49|
74043662|NCT03803202|147638805|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.44|1.14|||t-test, 2 sided|||Serotype 9V, Day 30||1.14|0.44|
74043663|NCT03803202|147638805|OTHER||Ratio of GMT|1.21|||||TWO_SIDED|95.0|0.76|1.95|||t-test, 2 sided|||Serotype 9V, Day 30||1.95|0.76|
74043664|NCT03803202|147638805|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.39|1.21|||t-test, 2 sided|||Serotype 6A, Day 30||1.21|0.39|
74043665|NCT03803202|147638805|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.54|1.5|||t-test, 2 sided|||Serotype 6A, Day 30||1.50|0.54|
74043666|NCT03803202|147638805|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.53|1.64|||t-test, 2 sided|||Serotype 6A, Day 30||1.64|0.53|
74043667|NCT03803202|147638805|OTHER||Ratio of GMT|1.33|||||TWO_SIDED|95.0|0.84|2.11|||t-test, 2 sided|||Serotype 14, Day 30||2.11|0.84|
74094826|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.56|0.95|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.95|0.56|<0.001
74043668|NCT03803202|147638805|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.55|1.43|||t-test, 2 sided|||Serotype 14, Day 30||1.43|0.55|
74043669|NCT03803202|147638805|OTHER||Ratio of GMT|1.54|||||TWO_SIDED|95.0|0.95|2.5|||t-test, 2 sided|||Serotype 14, Day 30||2.50|0.95|
74043670|NCT03803202|147638805|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.55|1.44|||t-test, 2 sided|||Serotype 18C, Day 30||1.44|0.55|
74043671|NCT03803202|147638805|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.63|1.54|||t-test, 2 sided|||Serotype 18C, Day 30||1.54|0.63|
74043672|NCT03803202|147638805|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.82|2.12|||t-test, 2 sided|||Serotype 18C, Day 30||2.12|0.82|
74043673|NCT03803202|147638805|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.7|1.37|||t-test, 2 sided|||Serotype 19A, Day 30||1.37|0.70|
74043674|NCT03803202|147638805|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.71|1.37|||t-test, 2 sided|||Serotype 19A, Day 30||1.37|0.71|
74043675|NCT03803202|147638805|OTHER||Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.78|1.67|||t-test, 2 sided|||Serotype 19A, Day 30||1.67|0.78|
74043676|NCT03803202|147638805|OTHER||Ratio of GMT|1.52||||||95.0|0.99|2.32|||t-test, 2 sided|||Serotype 19F, Day 30||2.32|0.99|
74043677|NCT03803202|147638805|OTHER||Ratio of GMT|1.48|||||TWO_SIDED|95.0|1.0|2.18|||t-test, 2 sided|||Serotype 19F, Day 30||2.18|1.00|
74043678|NCT03803202|147638805|OTHER||Ratio of GMT|2.08|||||TWO_SIDED|95.0|1.35|3.22|||t-test, 2 sided|||Serotype 19F, Day 30||3.22|1.35|
74043679|NCT03803202|147638805|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.36|1.26|||t-test, 2 sided|||Serotype 23F, Day 30||1.26|0.36|
74043680|NCT03803202|147638805|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.4|1.26|||t-test, 2 sided|||Serotype 23F, Day 30||1.26|0.40|
74043681|NCT03803202|147638805|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.47|1.73|||t-test, 2 sided|||Serotype 23F, Day 30||1.73|0.47|
74043682|NCT03803202|147638806|OTHER||Ratio of GMC|0.9|||||TWO_SIDED|95.0|0.57|1.42|||t-test, 2 sided|||Serotype 1, Day 1||1.42|0.57|
74043683|NCT03803202|147638806|OTHER||Ratio of GMC|1.85|||||TWO_SIDED|95.0|1.12|3.08|||t-test, 2 sided|||Serotype 1, Day 1||3.08|1.12|
74043684|NCT03803202|147638806|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.53|1.49|||t-test, 2 sided|||Serotype 1, Day 1||1.49|0.53|
74043685|NCT03803202|147638806|OTHER||Ratio of GMC|1.25|||||TWO_SIDED|95.0|0.84|1.87|||t-test, 2 sided|||Serotype 3, Day 1||1.87|0.84|
74043686|NCT03803202|147638806|OTHER||Ratio of GMC|1.79|||||TWO_SIDED|95.0|1.18|2.73|||t-test, 2 sided|||Serotype 3, Day 1||2.73|1.18|
74043687|NCT03803202|147638806|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.69|1.69|||t-test, 2 sided|||Serotype 3, Day 1||1.69|0.69|
74043688|NCT03803202|147638806|OTHER||Ratio of GMC|0.81|||||TWO_SIDED|95.0|0.54|1.21|||t-test, 2 sided|||Serotype 4, Day 1||1.21|0.54|
74043689|NCT03803202|147638806|OTHER||Ratio of GMC|1.16|||||TWO_SIDED|95.0|0.74|1.81|||t-test, 2 sided|||Serotype 4, Day 1||1.81|0.74|
74043690|NCT03803202|147638806|OTHER||Ratio of GMC|0.67|||||TWO_SIDED|95.0|0.44|1.0|||t-test, 2 sided|||Serotype 4, Day 1||1.00|0.44|
74043691|NCT03803202|147638806|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.65|1.78|||t-test, 2 sided|||Serotype 5, Day 1||1.78|0.65|
74043692|NCT03803202|147638806|OTHER||Ratio of GMC|1.59|||||TWO_SIDED|95.0|0.96|2.63|||t-test, 2 sided|||Serotype 5, Day 1||2.63|0.96|
74043693|NCT03803202|147638806|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.58|1.72|||t-test, 2 sided|||Serotype 5, Day 1||1.72|0.58|
74043694|NCT03803202|147638806|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.53|1.47|||t-test, 2 sided|||Serotype 6A, Day 1||1.47|0.53|
74043695|NCT03803202|147638806|OTHER||Ratio of GMC|1.39|||||TWO_SIDED|95.0|0.83|2.3|||t-test, 2 sided|||Serotype 6A, Day 1||2.30|0.83|
74043696|NCT03803202|147638806|OTHER||Ratio of GMC|1.4|||||TWO_SIDED|95.0|0.8|2.44|||t-test, 2 sided|||Serotype 6A, Day 1||2.44|0.80|
74043697|NCT03803202|147638806|OTHER||Ratio of GMC|1.17|||||TWO_SIDED|95.0|0.69|1.99|||t-test, 2 sided|||Serotype 6B, Day 1||1.99|0.69|
74043698|NCT03803202|147638806|OTHER||Ratio of GMC|2.09|||||TWO_SIDED|95.0|1.19|3.67|||t-test, 2 sided|||Serotype 6B, Day 1||3.67|1.19|
74043699|NCT03803202|147638806|OTHER||Ratio of GMC|1.59|||||TWO_SIDED|95.0|0.88|2.88|||t-test, 2 sided|||Serotype 6B, Day 1||2.88|0.88|
74043700|NCT03803202|147638806|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.62|1.65|||t-test, 2 sided|||Serotype 7F, Day 1||1.65|0.62|
74043701|NCT03803202|147638806|OTHER||Ratio of GMC|1.58|||||TWO_SIDED|95.0|0.94|2.67|||t-test, 2 sided|||Serotype 7F, Day 1||2.67|0.94|
74043702|NCT03803202|147638806|OTHER||Ratio of GMC|0.9|||||TWO_SIDED|95.0|0.5|1.64|||t-test, 2 sided|||Serotype 7F, Day 1||1.64|0.50|
74094827|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.82|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.36|0.82|<0.001
74014305|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3779|STANDARD_ERROR_OF_MEAN|1.0114||0.179|TWO_SIDED|80.0|0.06498|2.6908|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.6908|0.06498|0.1790
74014306|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8759|STANDARD_ERROR_OF_MEAN|0.7508||0.0156|TWO_SIDED|80.0|0.90156|2.8502|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.8502|0.90156|0.0156
74014307|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04217|STANDARD_ERROR_OF_MEAN|0.7842||0.9573|TWO_SIDED|80.0|-1.06|0.97559|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.97559|-1.060|0.9573
74014308|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1602|STANDARD_ERROR_OF_MEAN|1.2517||0.8986|TWO_SIDED|80.0|-1.462|1.782|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.7820|-1.462|0.8986
74014309|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6688|STANDARD_ERROR_OF_MEAN|1.3437||0.6204|TWO_SIDED|80.0|-1.071|2.4086|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.4086|-1.071|0.6204
74014310|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|0.492|STANDARD_ERROR_OF_MEAN|0.8742||0.5759|TWO_SIDED|80.0|-0.6421|1.6261|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.6261|-0.6421|0.5759
74014311|NCT00531752|147579631|SUPERIORITY_OR_OTHER||LS Mean Difference|0.875|STANDARD_ERROR_OF_MEAN|0.9488||0.3603|TWO_SIDED|80.0|-0.3552|2.1051|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.1051|-0.3552|0.3603
74043703|NCT03803202|147638806|OTHER||Ratio of GMC|0.79|||||TWO_SIDED|95.0|0.52|1.21|||t-test, 2 sided|||Serotype 9V, Day 1||1.21|0.52|
74043704|NCT03803202|147638806|OTHER||Ratio of GMC|1.57|||||TWO_SIDED|95.0|0.97|2.54|||t-test, 2 sided|||Serotype 9V, Day 1||2.54|0.97|
74094828|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|||<|0.001|TWO_SIDED|95.0|0.35|0.9|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|0.35|<0.001
74094829|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|||<|0.001|TWO_SIDED|95.0|0.27|0.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.27|<0.001
74014312|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5306|STANDARD_ERROR_OF_MEAN|1.6664||0.0392|TWO_SIDED|80.0|1.3659|5.6952|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.6952|1.3659|0.0392
74014313|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9344|STANDARD_ERROR_OF_MEAN|1.7848||0.0003|TWO_SIDED|80.0|4.6177|9.2512|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.2512|4.6177|0.0003
74014314|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2888|STANDARD_ERROR_OF_MEAN|2.1861||0.0547|TWO_SIDED|80.0|1.4544|7.1232|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.1232|1.4544|0.0547
74014315|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6799|STANDARD_ERROR_OF_MEAN|2.3261||0.0176|TWO_SIDED|80.0|2.6655|8.6943|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6943|2.6655|0.0176
74014316|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7203|STANDARD_ERROR_OF_MEAN|2.5085||0.775|TWO_SIDED|80.0|-2.53|3.9704|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.9704|-2.530|0.7750
74043705|NCT03803202|147638806|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.6|1.6|||t-test, 2 sided|||Serotype 9V, Day 1||1.60|0.60|
74043706|NCT03803202|147638806|OTHER||Ratio of GMC|0.73|||||TWO_SIDED|95.0|0.4|1.33|||t-test, 2 sided|||Serotype 14, Day 1||1.33|0.40|
74043707|NCT03803202|147638806|OTHER||Ratio of GMC|1.33|||||TWO_SIDED|95.0|0.73|2.44|||t-test, 2 sided|||Serotype 14, Day 1||2.44|0.73|
74094830|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|||<|0.001|TWO_SIDED|95.0|1.06|1.61|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|1.06|<0.001
74094831|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.003|TWO_SIDED|95.0|0.1|0.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.49|0.10|0.003
74094832|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|||<|0.001|TWO_SIDED|95.0|0.58|0.98|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.98|0.58|<0.001
74043708|NCT03803202|147638806|OTHER||Ratio of GMC|0.87|||||TWO_SIDED|95.0|0.46|1.63|||t-test, 2 sided|||Serotype 14, Day 1||1.63|0.46|
74043709|NCT03803202|147638806|OTHER||Ratio of GMC|0.69|||||TWO_SIDED|95.0|0.42|1.12|||t-test, 2 sided|||Serotype 18C, Day 1||1.12|0.42|
74043710|NCT03803202|147638806|OTHER||Ratio of GMC|1.53|||||TWO_SIDED|95.0|0.92|2.55|||t-test, 2 sided|||Serotype 18C, Day 1||2.55|0.92|
74043711|NCT03803202|147638806|OTHER||Ratio of GMC|0.78|||||TWO_SIDED|95.0|0.44|1.37|||t-test, 2 sided|||Serotype 18C, Day 1||1.37|0.44|
74043712|NCT03803202|147638806|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.54|1.25|||t-test, 2 sided|||Serotype 19A, Day 1||1.25|0.54|
74043713|NCT03803202|147638806|OTHER||Ratio of GMC|1.34|||||TWO_SIDED|95.0|0.84|2.12|||t-test, 2 sided|||Serotype 19A, Day 1||2.12|0.84|
74043714|NCT03803202|147638806|OTHER||Ratio of GMC|1.05|||||TWO_SIDED|95.0|0.66|1.66|||t-test, 2 sided|||Serotype 19A, Day 1||1.66|0.66|
74043715|NCT03803202|147638806|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.51|1.37|||t-test, 2 sided|||Serotype 19F, Day 1||1.37|0.51|
74043716|NCT03803202|147638806|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.75|2.11|||t-test, 2 sided|||Serotype 19F, Day 1||2.11|0.75|
74043717|NCT03803202|147638806|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.57|1.72|||t-test, 2 sided|||Serotype 19F, Day 1||1.72|0.57|
74043718|NCT03803202|147638806|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.63|1.86|||t-test, 2 sided|||Serotype 23F, Day 1||1.86|0.63|
74043719|NCT03803202|147638806|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.69|2.08|||t-test, 2 sided|||Serotype 23F, Day 1||2.08|0.69|
74043720|NCT03803202|147638806|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.67|2.14|||t-test, 2 sided|||Serotype 23F, Day 1||2.14|0.67|
74043721|NCT03803202|147638806|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.52|1.29|||t-test, 2 sided|||Serotype 1, Day 30||1.29|0.52|
74043722|NCT03803202|147638806|OTHER||Ratio of GMC|1.04|||||TWO_SIDED|95.0|0.68|1.59|||t-test, 2 sided|||Serotype 1, Day 30||1.59|0.68|
74043723|NCT03803202|147638806|OTHER||Ratio of GMC|1.17|||||TWO_SIDED|95.0|0.76|1.8|||t-test, 2 sided|||Serotype 1, Day 30||1.80|0.76|
74043724|NCT03803202|147638806|OTHER||Ratio of GMC|2.07|||||TWO_SIDED|95.0|1.42|3.01|||t-test, 2 sided|||Serotype 3, Day 30||3.01|1.42|
74094833|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04|||<|0.001|TWO_SIDED|95.0|0.76|1.32|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.32|0.76|<0.001
74094834|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.28|0.84|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.84|0.28|<0.001
74094835|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.29|0.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.68|0.29|<0.001
74094836|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|||<|0.001|TWO_SIDED|95.0|1.0|1.57|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.57|1.00|<0.001
74094837|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.50|0.10|0.003
74043725|NCT03803202|147638806|OTHER||Ratio of GMC|3.29|||||TWO_SIDED|95.0|2.37|4.58|||t-test, 2 sided|||Serotype 3, Day 30||4.58|2.37|
74043726|NCT03803202|147638806|OTHER||Ratio of GMC|4.05|||||TWO_SIDED|95.0|2.83|5.79|||t-test, 2 sided|||Serotype 3, Day 30||5.79|2.83|
74043727|NCT03803202|147638806|OTHER||Ratio of GMC|0.79|||||TWO_SIDED|95.0|0.49|1.27|||t-test, 2 sided|||Serotype 4, Day 30||1.27|0.49|
74043728|NCT03803202|147638806|OTHER||Ratio of GMC|0.97|||||TWO_SIDED|95.0|0.63|1.48|||t-test, 2 sided|||Serotype 4, Day 30||1.48|0.63|
74043729|NCT03803202|147638806|OTHER||Ratio of GMC|1.05|||||TWO_SIDED|95.0|0.66|1.65|||t-test, 2 sided|||Serotype 4, Day 30||1.65|0.66|
74043730|NCT03803202|147638806|OTHER||Ratio of GMC|1.31|||||TWO_SIDED|95.0|0.75|2.29|||t-test, 2 sided|||Serotype 5, Day 30||2.29|0.75|
74043731|NCT03803202|147638806|OTHER||Ratio of GMC|1.3|||||TWO_SIDED|95.0|0.77|2.19|||t-test, 2 sided|||Serotype 5, Day 30||2.19|0.77|
74043732|NCT03803202|147638806|OTHER||Ratio of GMC|1.91|||||TWO_SIDED|95.0|1.08|3.37|||t-test, 2 sided|||Serotype 5, Day 30||3.37|1.08|
74043733|NCT03803202|147638806|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.5|1.49|||t-test, 2 sided|||Serotype 6A, Day 30||1.49|0.50|
74043734|NCT03803202|147638806|OTHER||Ratio of GMC|1.06|||||TWO_SIDED|95.0|0.65|1.72|||t-test, 2 sided|||Serotype 6A, Day 30||1.72|0.65|
74043735|NCT03803202|147638806|OTHER||Ratio of GMC|1.22|||||TWO_SIDED|95.0|0.71|2.1|||t-test, 2 sided|||Serotype 6A, Day 30||2.10|0.71|
74094838|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.51|0.91|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.91|0.51|<0.001
74094839|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.7|1.27|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.70|<0.001
74094840|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|||<|0.001|TWO_SIDED|95.0|0.29|0.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.29|<0.001
74094841|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.61|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.21|<0.001
73880109|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5107|TWO_SIDED|95.0|0.45|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.98|0.45|0.5107
74014317|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04276|STANDARD_ERROR_OF_MEAN|2.6874||0.9874|TWO_SIDED|80.0|-3.521|3.4357|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.4357|-3.521|0.9874
74014318|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6252|STANDARD_ERROR_OF_MEAN|2.2268||0.7799|TWO_SIDED|80.0|-3.513|2.2629|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.2629|-3.513|0.7799
73880110|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1297|TWO_SIDED|95.0|0.78|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.22|0.78|0.1297
74014319|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1136|STANDARD_ERROR_OF_MEAN|2.3365||0.1881|TWO_SIDED|80.0|0.08338|6.1438|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.1438|0.08338|0.1881
74014320|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6575|STANDARD_ERROR_OF_MEAN|1.9677||0.4032|TWO_SIDED|80.0|-0.8944|4.2094|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2094|-0.8944|0.4032
74014321|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9254|STANDARD_ERROR_OF_MEAN|2.0796||0.0059|TWO_SIDED|80.0|3.2314|8.6193|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6193|3.2314|0.0059
74014322|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0921|STANDARD_ERROR_OF_MEAN|2.1098||0.6067|TWO_SIDED|80.0|-1.643|3.8273|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.8273|-1.643|0.6067
74014323|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2785|STANDARD_ERROR_OF_MEAN|2.2424||0.0614|TWO_SIDED|80.0|1.3709|7.186|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.1860|1.3709|0.0614
74014324|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7149|STANDARD_ERROR_OF_MEAN|2.2086||0.7476|TWO_SIDED|80.0|-3.584|2.1546|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.1546|-3.584|0.7476
73880111|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|7.04||||0.0005|TWO_SIDED|95.0|2.34|21.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.22|2.34|0.0005
74014325|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3355|STANDARD_ERROR_OF_MEAN|2.4396||0.5863|TWO_SIDED|80.0|-4.499|1.8284|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.8284|-4.499|0.5863
74014326|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1058|STANDARD_ERROR_OF_MEAN|2.0529||0.9591|TWO_SIDED|80.0|-2.771|2.5593|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.5593|-2.771|0.9591
74014327|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4352|STANDARD_ERROR_OF_MEAN|2.2048||0.8442|TWO_SIDED|80.0|-3.294|2.4238|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.4238|-3.294|0.8442
74014328|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6876|STANDARD_ERROR_OF_MEAN|2.0533||0.1977|TWO_SIDED|80.0|0.01391|5.3613|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.3613|0.01391|0.1977
74014329|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8149|STANDARD_ERROR_OF_MEAN|2.2467||0.4235|TWO_SIDED|80.0|-1.108|4.7375|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.7375|-1.108|0.4235
74014330|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6424|STANDARD_ERROR_OF_MEAN|1.9753||0.1882|TWO_SIDED|80.0|0.07015|5.2147|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.2147|0.07015|0.1882
74014331|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2105|STANDARD_ERROR_OF_MEAN|2.0376||0.5555|TWO_SIDED|80.0|-1.44|3.8615|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.8615|-1.440|0.5555
74014332|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1804|STANDARD_ERROR_OF_MEAN|2.1934||0.1533|TWO_SIDED|80.0|0.33169|6.0292|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.0292|0.33169|0.1533
74014333|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0511|STANDARD_ERROR_OF_MEAN|2.2662||0.3697|TWO_SIDED|80.0|-0.8912|4.9934|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.9934|-0.8912|0.3697
74043736|NCT03803202|147638806|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.56|1.75|||t-test, 2 sided|||Serotype 6B, Day 30||1.75|0.56|
74043737|NCT03803202|147638806|OTHER||Ratio of GMC|1.44|||||TWO_SIDED|95.0|0.84|2.47|||t-test, 2 sided|||Serotype 6B, Day 30||2.47|0.84|
74014334|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|1.764|STANDARD_ERROR_OF_MEAN|2.3939||0.4652|TWO_SIDED|80.0|-1.352|4.8801|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.8801|-1.352|0.4652
74014335|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4377|STANDARD_ERROR_OF_MEAN|2.5148||0.8626|TWO_SIDED|80.0|-2.83|3.7058|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.7058|-2.830|0.8626
74014336|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7114|STANDARD_ERROR_OF_MEAN|1.6168||0.0261|TWO_SIDED|80.0|1.6105|5.8122|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.8122|1.6105|0.0261
74014337|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2644|STANDARD_ERROR_OF_MEAN|1.7026||0.1895|TWO_SIDED|80.0|0.0533|4.4756|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.4756|0.05330|0.1895
74014338|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1151|STANDARD_ERROR_OF_MEAN|3.0732||0.4994|TWO_SIDED|80.0|-1.961|6.1913|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.1913|-1.961|0.4994
74014339|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5616|STANDARD_ERROR_OF_MEAN|3.3113||0.2945|TWO_SIDED|80.0|-0.8226|7.9458|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.9458|-0.8226|0.2945
74043738|NCT03803202|147638806|OTHER||Ratio of GMC|1.77|||||TWO_SIDED|95.0|1.0|3.15|||t-test, 2 sided|||Serotype 6B, Day 30||3.15|1.00|
74043739|NCT03803202|147638806|OTHER||Ratio of GMC|1.54|||||TWO_SIDED|95.0|1.02|2.3|||t-test, 2 sided|||Serotype 7F, Day 30||2.30|1.02|
74043740|NCT03803202|147638806|OTHER||Ratio of GMC|1.55|||||TWO_SIDED|95.0|1.06|2.26|||t-test, 2 sided|||Serotype 7F, Day 30||2.26|1.06|
74043741|NCT03803202|147638806|OTHER||Ratio of GMC|1.66|||||TWO_SIDED|95.0|1.09|2.53|||t-test, 2 sided|||Serotype 7F, Day 30||2.53|1.09|
74043742|NCT03803202|147638806|OTHER||Ratio of GMC|1.29|||||TWO_SIDED|95.0|0.81|2.07|||t-test, 2 sided|||Serotype 9V, Day 30||2.07|0.81|
74043743|NCT03803202|147638806|OTHER||Ratio of GMC|1.64|||||TWO_SIDED|95.0|1.04|2.57|||t-test, 2 sided|||Serotype 9V, Day 30||2.57|1.04|
74043744|NCT03803202|147638806|OTHER||Ratio of GMC|2.16|||||TWO_SIDED|95.0|1.35|3.47|||t-test, 2 sided|||Serotype 9V, Day 30||3.47|1.35|
74043745|NCT03803202|147638806|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.58|1.68|||t-test, 2 sided|||Serotype 14, Day 30||1.68|0.58|
74043746|NCT03803202|147638806|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.77|2.05|||t-test, 2 sided|||Serotype 14, Day 30||2.05|0.77|
74094842|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||<|0.001|TWO_SIDED|95.0|0.81|1.38|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.81|<0.001
74043747|NCT03803202|147638806|OTHER||Ratio of GMC|1.67|||||TWO_SIDED|95.0|0.99|2.81|||t-test, 2 sided|||Serotype 14, Day 30||2.81|0.99|
74043748|NCT03803202|147638806|OTHER||Ratio of GMC|0.61|||||TWO_SIDED|95.0|0.39|0.95|||t-test, 2 sided|||Serotype 18C, Day 30||0.95|0.39|
74043749|NCT03803202|147638806|OTHER||Ratio of GMC|1.04|||||TWO_SIDED|95.0|0.7|1.54|||t-test, 2 sided|||Serotype 18C, Day 30||1.54|0.70|
74043750|NCT03803202|147638806|OTHER||Ratio of GMC|1.03|||||TWO_SIDED|95.0|0.67|1.57|||t-test, 2 sided|||Serotype 18C, Day 30||1.57|0.67|
74043751|NCT03803202|147638806|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.56|1.25|||t-test, 2 sided|||Serotype 19A, Day 30||1.25|0.56|
74043752|NCT03803202|147638806|OTHER||Ratio of GMC|1.07|||||TWO_SIDED|95.0|0.75|1.52|||t-test, 2 sided|||Serotype 19A, Day 30||1.52|0.75|
74043753|NCT03803202|147638806|OTHER||Ratio of GMC|1.2|||||TWO_SIDED|95.0|0.77|1.86|||t-test, 2 sided|||Serotype 19A, Day 30||1.86|0.77|
74043754|NCT03803202|147638806|OTHER||Ratio of GMC|1.2|||||TWO_SIDED|95.0|0.76|1.9|||t-test, 2 sided|||Serotype 19F, Day 30||1.90|0.76|
74043755|NCT03803202|147638806|OTHER||Ratio of GMC|1.69|||||TWO_SIDED|95.0|1.11|2.58|||t-test, 2 sided|||Serotype 19F, Day 30||2.58|1.11|
74043756|NCT03803202|147638806|OTHER||Ratio of GMC|2.23|||||TWO_SIDED|95.0|1.41|3.52|||t-test, 2 sided|||Serotype 19F, Day 30||3.52|1.41|
74094843|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.014|TWO_SIDED|95.0|0.05|0.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|0.05|0.014
74094844|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66|||<|0.001|TWO_SIDED|95.0|0.45|0.86|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.45|<0.001
74094845|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.85|||<|0.001|TWO_SIDED|95.0|0.56|1.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.13|0.56|<0.001
74094846|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.003|TWO_SIDED|95.0|0.15|0.73|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.15|0.003
74094847|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.21|<0.001
74094848|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91|||<|0.001|TWO_SIDED|95.0|0.62|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.62|<0.001
74043757|NCT03803202|147638806|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.5|1.47|||t-test, 2 sided|||Serotype 23F, Day 30||1.47|0.50|
74043758|NCT03803202|147638806|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.51|1.35|||t-test, 2 sided|||Serotype 23F, Day 30||1.35|0.51|
74043759|NCT03803202|147638806|OTHER||Ratio of GMC|1.18|||||TWO_SIDED|95.0|0.69|2.02|||t-test, 2 sided|||Serotype 23F, Day 30||2.02|0.69|
74043760|NCT03803202|147638809|OTHER||Mean Difference|0.1||||0.805|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Serotype 1, Day 30||0.5|-0.4|0.805
74043761|NCT03803202|147638809|OTHER||Mean Difference|0.4||||0.102|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 1, Day 30||0.9|-0.1|0.102
74043762|NCT03803202|147638809|OTHER||Mean Difference|0.4||||0.158|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 1, Day 30||0.9|-0.1|0.158
74043763|NCT03803202|147638809|OTHER||Mean Difference|-0.1||||0.596|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Serotype 2, Day 30||0.2|-0.4|0.596
74043764|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.025|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.0|0.025
74043765|NCT03803202|147638809|OTHER||Mean Difference|0.4||||0.005|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.1|0.005
74043766|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.037|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 3, Day 30||0.7|0.0|0.037
74043767|NCT03803202|147638809|OTHER||Mean Difference|0.6||||0.002|TWO_SIDED|95.0|0.2|0.9|||ANCOVA|||Serotype 3, Day 30||0.9|0.2|0.002
74094849|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.041|TWO_SIDED|95.0|0.01|0.42|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|0.01|0.041
74094850|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.35|0.76|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.35|<0.001
74094851|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.41|0.99|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.99|0.41|<0.001
74094852|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.018|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.018
74094853|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.001|TWO_SIDED|95.0|0.14|0.55|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.55|0.14|0.001
74014340|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7306|STANDARD_ERROR_OF_MEAN|2.9257||0.8056|TWO_SIDED|80.0|-4.622|3.1613|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.1613|-4.622|0.8056
74014341|NCT00531752|147579632|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3672|STANDARD_ERROR_OF_MEAN|3.8657||0.3922|TWO_SIDED|80.0|-1.725|8.4592|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.4592|-1.725|0.3922
74014342|NCT00531752|147579633|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5069|STANDARD_ERROR_OF_MEAN|0.8744||0.0913|TWO_SIDED|80.0|-2.643|-0.3705|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3705|-2.643|0.0913
74014343|NCT00531752|147579633|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2078|STANDARD_ERROR_OF_MEAN|0.9165||0.8216|TWO_SIDED|80.0|-1.399|0.98326|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.98326|-1.399|0.8216
74014344|NCT00531752|147579634|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4181|STANDARD_ERROR_OF_MEAN|0.6887||0.5466|TWO_SIDED|80.0|-1.313|0.47668|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.47668|-1.313|0.5466
74014345|NCT00531752|147579634|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02518|STANDARD_ERROR_OF_MEAN|0.6772||0.9705|TWO_SIDED|80.0|-0.9035|0.85312|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.85312|-0.9035|0.9705
74014346|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09953|STANDARD_ERROR_OF_MEAN|0.3001||0.7415|TWO_SIDED|80.0|-0.4892|0.29012|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29012|-0.4892|0.7415
74014347|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04804|STANDARD_ERROR_OF_MEAN|0.3227||0.8822|TWO_SIDED|80.0|-0.3703|0.4664|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46640|-0.3703|0.8822
74014348|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|0.125|STANDARD_ERROR_OF_MEAN|0.1302||0.3414|TWO_SIDED|80.0|-0.0439|0.29385|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29385|-0.0439|0.3414
74014349|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1044|STANDARD_ERROR_OF_MEAN|0.1418||0.4642|TWO_SIDED|80.0|-0.0793|0.28814|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.28814|-0.0793|0.4642
74014350|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06109|STANDARD_ERROR_OF_MEAN|0.09093||0.5049|TWO_SIDED|80.0|-0.0571|0.17926|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.17926|-0.0571|0.5049
74014351|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07917|STANDARD_ERROR_OF_MEAN|0.1002||0.4332|TWO_SIDED|80.0|-0.051|0.2093|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.20930|-0.0510|0.4332
74014352|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2453|STANDARD_ERROR_OF_MEAN|0.1753||0.1678|TWO_SIDED|80.0|-0.473|-0.0177|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0177|-0.4730|0.1678
74014353|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07717|STANDARD_ERROR_OF_MEAN|0.1925||0.6901|TWO_SIDED|80.0|-0.1726|0.32695|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.32695|-0.1726|0.6901
74014354|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1702|STANDARD_ERROR_OF_MEAN|1.354||0.9005|TWO_SIDED|80.0|-1.587|1.9274|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.9274|-1.587|0.9005
74014355|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4317|STANDARD_ERROR_OF_MEAN|1.4667||0.333|TWO_SIDED|80.0|-3.333|0.46937|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46937|-3.333|0.3330
74014356|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6537|STANDARD_ERROR_OF_MEAN|2.0857||0.7551|TWO_SIDED|80.0|-2.051|3.3584|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3584|-2.051|0.7551
74014357|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.8639|STANDARD_ERROR_OF_MEAN|2.2354||0.0334|TWO_SIDED|80.0|-7.759|-1.968|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.968|-7.759|0.0334
74043768|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.23|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 3, Day 30||0.6|-0.1|0.230
74043769|NCT03803202|147638809|OTHER||Mean Difference|0.0||||0.984|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 4, Day 30||0.4|-0.4|0.984
74014358|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6389|STANDARD_ERROR_OF_MEAN|3.6119||0.6519|TWO_SIDED|80.0|-3.05|6.3281|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.3281|-3.050|0.6519
74014359|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2007|STANDARD_ERROR_OF_MEAN|3.9647||0.7631|TWO_SIDED|80.0|-3.941|6.3423|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.3423|-3.941|0.7631
74014360|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9211|STANDARD_ERROR_OF_MEAN|2.8206||0.3034|TWO_SIDED|80.0|-0.7227|6.5648|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.5648|-0.7227|0.3034
74014361|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.0968|STANDARD_ERROR_OF_MEAN|3.0022||0.0933|TWO_SIDED|80.0|-8.975|-1.218|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.218|-8.975|0.0933
74043770|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.262|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.262
74043771|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.264|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.264
74043772|NCT03803202|147638809|OTHER||Mean Difference|0.1||||0.638|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 5, Day 30||0.6|-0.4|0.638
74043773|NCT03803202|147638809|OTHER||Mean Difference|0.5||||0.036|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 5, Day 30||1.0|0.0|0.036
74043774|NCT03803202|147638809|OTHER||Mean Difference|0.4||||0.094|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.094
74043775|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.266|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 6A, Day 30||0.8|-0.2|0.266
74043776|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.25|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 6A, Day 30||0.8|-0.2|0.250
74094854|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.48|1.05|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.48|<0.001
73880112|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|8.5||||0.0001|TWO_SIDED|95.0|2.82|25.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||25.63|2.82|0.0001
74014362|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.0675|STANDARD_ERROR_OF_MEAN|2.9778||0.0949|TWO_SIDED|80.0|-8.934|-1.201|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.201|-8.934|0.0949
74014363|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.3274|STANDARD_ERROR_OF_MEAN|3.2552||0.0283|TWO_SIDED|80.0|-11.55|-3.106|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-3.106|-11.55|0.0283
74043777|NCT03803202|147638809|OTHER||Mean Difference|0.0||||0.927|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Serotype 6A, Day 30||0.5|-0.5|0.927
74043778|NCT03803202|147638809|OTHER||Mean Difference|-0.1||||0.679|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Serotype 6B, Day 30||0.3|-0.5|0.679
74043779|NCT03803202|147638809|OTHER||Mean Difference|-0.1||||0.589|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 6B, Day 30||0.3|-0.6|0.589
74043780|NCT03803202|147638809|OTHER||Mean Difference|0.0||||0.88|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 6B, Day 30||0.4|-0.5|0.880
74043781|NCT03803202|147638809|OTHER||Mean Difference|0.1||||0.623|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.2|0.623
74043782|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.232|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 7F, Day 30||0.6|-0.1|0.232
74043783|NCT03803202|147638809|OTHER||Mean Difference|0.1||||0.451|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 7F, Day 30||0.5|-0.2|0.451
74043784|NCT03803202|147638809|OTHER||Mean Difference|0.0||||0.785|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 8, Day 30||0.4|-0.3|0.785
74043785|NCT03803202|147638809|OTHER||Mean Difference|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.1|||ANCOVA|||Serotype 8, Day 30||1.1|0.4|<.001
74043786|NCT03803202|147638809|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.4|1.1|||ANCOVA|||Serotype 8, Day 30||1.1|0.4|<.001
74043787|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||Serotype 9N, Day 30||0.5|-0.1|0.146
74043788|NCT03803202|147638809|OTHER||Mean Difference|0.5||||0.003|TWO_SIDED|95.0|0.2|0.8|||ANCOVA|||Serotype 9N, Day 30||0.8|0.2|0.003
74043789|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.113|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 9N, Day 30||0.6|-0.1|0.113
74043790|NCT03803202|147638809|OTHER||Mean Difference|-0.2||||0.453|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 9V, Day 30||0.3|-0.6|0.453
74043791|NCT03803202|147638809|OTHER||Mean Difference|0.4||||0.111|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 9V, Day 30||0.8|-0.1|0.111
74043792|NCT03803202|147638809|OTHER||Mean Difference|0.5||||0.02|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 9V, Day 30||1.0|0.1|0.020
74043793|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.218|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 10A, Day 30||0.8|-0.2|0.218
74043794|NCT03803202|147638809|OTHER||Mean Difference|0.4||||0.125|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 10A, Day 30||0.9|-0.1|0.125
74043795|NCT03803202|147638809|OTHER||Mean Difference|0.1||||0.706|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 10A, Day 30||0.6|-0.4|0.706
74043796|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.246|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 11A, Day 30||0.6|-0.1|0.246
74043797|NCT03803202|147638809|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.1|||ANCOVA|||Serotype 11A, Day 30||1.1|0.3|<.001
74043798|NCT03803202|147638809|OTHER||Mean Difference|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 11A, Day 30||0.9|0.1|0.010
74094855|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.045|TWO_SIDED|95.0|0.0|0.4|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|0.00|0.045
74014364|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1505|STANDARD_ERROR_OF_MEAN|1.5974||0.1852|TWO_SIDED|80.0|-4.229|-0.0719|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0719|-4.229|0.1852
74014365|NCT00531752|147579635|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5178|STANDARD_ERROR_OF_MEAN|1.7732||0.1623|TWO_SIDED|80.0|-4.823|-0.2127|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.2127|-4.823|0.1623
74014366|NCT00531752|147579636|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.5791|STANDARD_ERROR_OF_MEAN|18.0449||0.5241|TWO_SIDED|80.0|-35.02|11.86|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||11.860|-35.02|0.5241
74014367|NCT00531752|147579636|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.3367|STANDARD_ERROR_OF_MEAN|19.6995||0.3065|TWO_SIDED|80.0|-45.89|5.2183|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.2183|-45.89|0.3065
74014368|NCT00531752|147579636|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.7878|STANDARD_ERROR_OF_MEAN|13.4438||0.3831|TWO_SIDED|80.0|-29.15|5.5793|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5793|-29.15|0.3831
74014369|NCT00531752|147579636|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.1401|STANDARD_ERROR_OF_MEAN|14.4478||0.3657|TWO_SIDED|80.0|-31.8|5.5241|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5241|-31.80|0.3657
74043799|NCT03803202|147638809|OTHER||Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Serotype 12F, Day 30||0.2|-0.7|0.260
74014370|NCT00531752|147579636|SUPERIORITY_OR_OTHER||LS Mean Difference|2.666|STANDARD_ERROR_OF_MEAN|11.5818||0.8188|TWO_SIDED|80.0|-12.36|17.69|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||17.690|-12.36|0.8188
74014371|NCT00531752|147579636|SUPERIORITY_OR_OTHER||LS Mean Difference|24.1011|STANDARD_ERROR_OF_MEAN|12.405||0.0566|TWO_SIDED|80.0|8.0305|40.172|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||40.172|8.0305|0.0566
74014372|NCT00531752|147579636|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7559|STANDARD_ERROR_OF_MEAN|8.7164||0.9312|TWO_SIDED|80.0|-10.55|12.057|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.057|-10.55|0.9312
74043800|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.366|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Serotype 12F, Day 30||0.7|-0.3|0.366
74043801|NCT03803202|147638809|OTHER||Mean Difference|0.5||||0.046|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 12F, Day 30||1.0|0.0|0.046
74043802|NCT03803202|147638809|OTHER||Mean Difference|-0.4||||0.101|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Serotype 14, Day 30||0.1|-0.8|0.101
74014373|NCT00531752|147579636|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1138|STANDARD_ERROR_OF_MEAN|9.4361||0.5194|TWO_SIDED|80.0|-6.108|18.336|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||18.336|-6.108|0.5194
74014374|NCT00531752|147579637|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3255|STANDARD_ERROR_OF_MEAN|0.332||0.332|TWO_SIDED|80.0|-0.7573|0.10622|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.10622|-0.7573|0.3320
74043803|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.522||95.0|-0.3|0.6|||ANCOVA|||Serotype 14, Day 30||0.6|-0.3|0.522
74043804|NCT03803202|147638809|OTHER||Mean Difference|0.5||||0.026|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 14, Day 30||1.0|0.1|0.026
74043805|NCT03803202|147638809|OTHER||Mean Difference|-0.2||||0.236|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Serotype 15B, Day 30||0.2|-0.6|0.236
74043806|NCT03803202|147638809|OTHER||Mean Difference|0.1||||0.528|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 15B, Day 30||0.5|-0.3|0.528
74043807|NCT03803202|147638809|OTHER||Mean Difference|0.4||||0.081|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 15B, Day 30||0.8|0.0|0.081
74043808|NCT03803202|147638809|OTHER||Mean Difference|-0.1||||0.388|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Serotype 17F, Day 30||0.2|-0.5|0.388
74043809|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.151|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.1|0.151
74043810|NCT03803202|147638809|OTHER||Mean Difference|0.4||||0.024|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Serotype 17F, Day 30||0.7|0.1|0.024
74043811|NCT03803202|147638809|OTHER||Mean Difference|0.1||||0.476|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 18C, Day 30||0.5|-0.3|0.476
74043812|NCT03803202|147638809|OTHER||Mean Difference|0.4||||0.077|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 18C, Day 30||0.8|0.0|0.077
74043813|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.262|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 18C, Day 30||0.6|-0.2|0.262
74043814|NCT03803202|147638809|OTHER||Mean Difference|0.0||||0.767|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 19A, Day 30||0.4|-0.3|0.767
74043815|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.364|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.2|0.364
74043816|NCT03803202|147638809|OTHER||Mean Difference|0.1||||0.522|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.2|0.522
74043817|NCT03803202|147638809|OTHER||Mean Difference|0.0||||0.962|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 19F, Day 30||0.4|-0.4|0.962
74043818|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.091|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.1|0.091
74043819|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.093|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.1|0.093
74043820|NCT03803202|147638809|OTHER||Mean Difference|-0.2||||0.455|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 20B, Day 30||0.3|-0.6|0.455
74014375|NCT00531752|147579637|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4255|STANDARD_ERROR_OF_MEAN|0.3871||0.2767|TWO_SIDED|80.0|-0.0769|0.92804|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.92804|-0.0769|0.2767
74014376|NCT00531752|147579637|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3661|STANDARD_ERROR_OF_MEAN|0.4028||0.3675|TWO_SIDED|80.0|-0.8887|0.1566|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.15660|-0.8887|0.3675
74014377|NCT00531752|147579637|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1033|STANDARD_ERROR_OF_MEAN|0.4372||0.8141|TWO_SIDED|80.0|-0.67|0.46345|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46345|-0.6700|0.8141
74014378|NCT00531752|147579637|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1854|STANDARD_ERROR_OF_MEAN|0.3702||0.6186|TWO_SIDED|80.0|-0.6657|0.29495|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29495|-0.6657|0.6186
74014379|NCT00531752|147579637|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3623|STANDARD_ERROR_OF_MEAN|0.4028||0.372|TWO_SIDED|80.0|-0.1597|0.88432|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.88432|-0.1597|0.3720
74014380|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0781|STANDARD_ERROR_OF_MEAN|5.0238|<|0.0001|TWO_SIDED|80.0|18.565|31.591|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||31.591|18.565|<0.0001
74014381|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|15.6481|STANDARD_ERROR_OF_MEAN|5.3551||0.0049|TWO_SIDED|80.0|8.711|22.585|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||22.585|8.7110|0.0049
74014382|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.627|STANDARD_ERROR_OF_MEAN|3.5248||0.3078|TWO_SIDED|80.0|-8.196|0.94237|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.94237|-8.196|0.3078
74014383|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1594|STANDARD_ERROR_OF_MEAN|3.8022||0.0644|TWO_SIDED|80.0|2.2344|12.084|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.084|2.2344|0.0644
74014384|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5601|STANDARD_ERROR_OF_MEAN|3.1318||0.1517|TWO_SIDED|80.0|0.49198|8.6281|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6281|0.49198|0.1517
74014385|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7384|STANDARD_ERROR_OF_MEAN|3.3281||0.8252|TWO_SIDED|80.0|-5.056|3.5789|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.5789|-5.056|0.8252
74014386|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6228|STANDARD_ERROR_OF_MEAN|0.2203||0.0063|TWO_SIDED|80.0|-0.9082|-0.3375|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3375|-0.9082|0.0063
74014387|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2301|STANDARD_ERROR_OF_MEAN|0.2303||0.3217|TWO_SIDED|80.0|-0.5283|0.06822|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.06822|-0.5283|0.3217
74014388|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1291|STANDARD_ERROR_OF_MEAN|0.1065||0.2307|TWO_SIDED|80.0|-0.0091|0.26716|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.26716|-0.0091|0.2307
74014389|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08114|STANDARD_ERROR_OF_MEAN|0.1087||0.4585|TWO_SIDED|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.22209|-0.0598|0.4585
74043821|NCT03803202|147638809|OTHER||Mean Difference|0.4||||0.093|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 20B, Day 30||0.9|-0.1|0.093
74014390|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.6629|STANDARD_ERROR_OF_MEAN|3.8642||0.3477|TWO_SIDED|80.0|-8.681|1.3549|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.3549|-8.681|0.3477
74014391|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8688|STANDARD_ERROR_OF_MEAN|4.0842||0.1565|TWO_SIDED|80.0|-11.17|-0.5693|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.5693|-11.17|0.1565
74043822|NCT03803202|147638809|OTHER||Mean Difference|0.6||||0.017|TWO_SIDED|95.0|0.1|1.1|||ANCOVA|||Serotype 20B, Day 30||1.1|0.1|0.017
74043823|NCT03803202|147638809|OTHER||Mean Difference|-0.1||||0.561|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Serotype 22F, Day 30||0.3|-0.5|0.561
74094856|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|||<|0.001|TWO_SIDED|95.0|0.24|0.64|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|0.24|<0.001
74094857|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.28|0.84|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.84|0.28|< 0.001
74094858|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.027|TWO_SIDED|95.0|0.04|0.61|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.04|0.027
74094859|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.02|TWO_SIDED|95.0|0.04|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|0.04|0.020
74094860|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|||<|0.001|TWO_SIDED|95.0|0.29|0.85|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.85|0.29|<0.001
74094861|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.374|TWO_SIDED|95.0|-0.11|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.11|0.374
74094862|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|||<|0.001|TWO_SIDED|95.0|0.14|0.54|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.54|0.14|<0.001
74094863|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.2|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.20|<0.001
74094864|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.106|TWO_SIDED|95.0|-0.05|0.51|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.05|0.106
74094865|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.013|TWO_SIDED|95.0|0.05|0.45|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|0.05|0.013
74094866|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.006|TWO_SIDED|95.0|0.11|0.67|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|0.11|0.006
74094867|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.796|TWO_SIDED|95.0|-0.17|0.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.22|-0.17|0.796
74094868|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.104|TWO_SIDED|95.0|-0.03|0.36|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.36|-0.03|0.104
74094869|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.01|TWO_SIDED|95.0|0.09|0.65|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.09|0.010
74094870|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.114|TWO_SIDED|95.0|-0.05|0.51|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.05|0.114
74094871|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.168|TWO_SIDED|95.0|-0.06|0.34|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.34|-0.06|0.168
74094872|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.022|TWO_SIDED|95.0|0.05|0.59|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.59|0.05|0.022
74094873|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.62|TWO_SIDED|95.0|-0.14|0.24|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.24|-0.14|0.620
74094874|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.164|TWO_SIDED|95.0|-0.06|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.33|-0.06|0.164
74094875|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.052|TWO_SIDED|95.0|0.0|0.54|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.54|-0.00|0.052
74094876|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.196|TWO_SIDED|95.0|-0.09|0.45|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|-0.09|0.196
74094877|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.364|TWO_SIDED|95.0|-0.1|0.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.10|0.364
74094878|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.071|TWO_SIDED|95.0|-0.02|0.52|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|-0.02|0.071
74094879|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.865||95.0|-0.2|0.17|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.17|-0.20|0.865
74014392|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.4319|STANDARD_ERROR_OF_MEAN|3.9541||0.1088|TWO_SIDED|80.0|-11.55|-1.311|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.311|-11.55|0.1088
74014393|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7208|STANDARD_ERROR_OF_MEAN|4.1517||0.8627|TWO_SIDED|80.0|-4.654|6.0952|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.0952|-4.654|0.8627
74014394|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|56.631|STANDARD_ERROR_OF_MEAN|17.8056||0.0024|TWO_SIDED|80.0|33.532|79.73|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||79.730|33.532|0.0024
74014395|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|49.1543|STANDARD_ERROR_OF_MEAN|18.7622||0.0112|TWO_SIDED|80.0|24.831|73.478|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||73.478|24.831|0.0112
74014396|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|10.9197|STANDARD_ERROR_OF_MEAN|3.0912||0.0008|TWO_SIDED|80.0|6.9105|14.929|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||14.929|6.9105|0.0008
74014397|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4691|STANDARD_ERROR_OF_MEAN|3.3037||0.0129|TWO_SIDED|80.0|4.1876|12.751|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.751|4.1876|0.0129
74014398|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|14.1078|STANDARD_ERROR_OF_MEAN|4.3667||0.002|TWO_SIDED|80.0|8.4492|19.766|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||19.766|8.4492|0.0020
74043824|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.343|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 22F, Day 30||0.6|-0.2|0.343
74043825|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.132|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 22F, Day 30||0.7|-0.1|0.132
74094880|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.238|TWO_SIDED|95.0|-0.08|0.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.30|-0.08|0.238
73880113|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.84||||0.299|TWO_SIDED|95.0|0.58|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.81|0.58|0.2990
74043826|NCT03803202|147638809|OTHER||Mean Difference|0.0||||0.898|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Serotype 23F, Day 30||0.6|-0.5|0.898
74043827|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.313|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||Serotype 23F, Day 30||0.9|-0.3|0.313
74043828|NCT03803202|147638809|OTHER||Mean Difference|0.3||||0.366|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.3|0.366
74043829|NCT03803202|147638809|OTHER||Mean Difference|0.0||||0.961|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 33F, Day 30||0.4|-0.4|0.961
74043830|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.269|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 33F, Day 30||0.6|-0.2|0.269
73888024|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|52.5||||0.2423|TWO_SIDED|95.0|-35.9|140.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||140.9|-35.9|0.2423
74014399|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|14.3485|STANDARD_ERROR_OF_MEAN|4.5692||0.0026|TWO_SIDED|80.0|8.4275|20.27|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||20.270|8.4275|0.0026
74014400|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2989|STANDARD_ERROR_OF_MEAN|3.4103||0.9305|TWO_SIDED|80.0|-4.729|4.1309|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.1309|-4.729|0.9305
74014401|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.7062|STANDARD_ERROR_OF_MEAN|3.5839||0.1178|TWO_SIDED|80.0|-10.36|-1.05|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.050|-10.36|0.1178
74014402|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4586|STANDARD_ERROR_OF_MEAN|2.5231||0.3339|TWO_SIDED|80.0|-0.8124|5.7295|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.7295|-0.8124|0.3339
74043831|NCT03803202|147638809|OTHER||Mean Difference|0.2||||0.245|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 33F, Day 30||0.6|-0.2|0.245
74043832|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.213|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 1, Day 30||0.7|-0.1|0.213
74043833|NCT03803202|147638810|OTHER||Mean Difference|0.4||||0.097|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 1, Day 30||0.8|-0.1|0.097
74043834|NCT03803202|147638810|OTHER||Mean Difference|0.1||||0.631|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 1, Day 30||0.5|-0.3|0.631
74043835|NCT03803202|147638810|OTHER||Mean Difference|0.1||||0.699|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 2, Day 30||0.4|-0.3|0.699
74094881|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.054|TWO_SIDED|95.0|0.0|0.53|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.00|0.054
74094882|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.335|TWO_SIDED|95.0|-0.14|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.14|0.335
74014403|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|4.859|STANDARD_ERROR_OF_MEAN|2.63||0.0698|TWO_SIDED|80.0|1.4493|8.2686|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.2686|1.4493|0.0698
74014404|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3364|STANDARD_ERROR_OF_MEAN|0.1859||0.0762|TWO_SIDED|80.0|-0.5777|-0.095|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0950|-0.5777|0.0762
74014405|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1591|STANDARD_ERROR_OF_MEAN|0.1913||0.4096|TWO_SIDED|80.0|-0.4075|0.08935|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.08935|-0.4075|0.4096
74043836|NCT03803202|147638810|OTHER||Mean Difference|0.4||||0.042|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.0|0.042
74043837|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.092|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|-0.1|0.092
74043838|NCT03803202|147638810|OTHER||Mean Difference|0.5||||0.007|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 3, Day 30||0.8|0.1|0.007
74043839|NCT03803202|147638810|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|||Serotype 3, Day 30||1.0|0.3|<.001
74043840|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.237|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 3, Day 30||0.6|-0.1|0.237
74043841|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.248|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.248
74043842|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.193|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 4, Day 30||0.7|-0.1|0.193
74043843|NCT03803202|147638810|OTHER||Mean Difference|0.0||||0.838|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Serotype 4, Day 30||0.5|-0.4|0.838
74043844|NCT03803202|147638810|OTHER||Mean Difference|0.0||||0.898|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 5, Day 30||0.4|-0.5|0.898
74043845|NCT03803202|147638810|OTHER||Mean Difference|0.4||||0.143|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.143
74043846|NCT03803202|147638810|OTHER||Mean Difference|0.4||||0.108|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.108
74043847|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.396|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Serotype 6A, Day 30||0.7|-0.3|0.396
74043848|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.182|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Serotype 6A, Day 30||0.9|-0.2|0.182
74043849|NCT03803202|147638810|OTHER||Mean Difference|0.1||||0.593|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 6A, Day 30||0.6|-0.4|0.593
74043850|NCT03803202|147638810|OTHER||Mean Difference|0.4||||0.186|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Serotype 6B, Day 30||0.9|-0.2|0.186
74043851|NCT03803202|147638810|OTHER||Mean Difference|0.6||||0.038|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Serotype 6B, Day 30||1.1|0.0|0.038
74043852|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.408|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Serotype 6B, Day 30||0.8|-0.3|0.408
74043853|NCT03803202|147638810|OTHER||Mean Difference|0.1||||0.805|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.3|0.805
74043854|NCT03803202|147638810|OTHER||Mean Difference|0.1||||0.711|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 7F, Day 30||0.5|-0.3|0.711
74043855|NCT03803202|147638810|OTHER||Mean Difference|0.0||||0.891|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.4|0.891
74043856|NCT03803202|147638810|OTHER||Mean Difference|0.1||||0.649|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 8, Day 30||0.4|-0.3|0.649
74043857|NCT03803202|147638810|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|||Serotype 8, Day 30||1.0|0.3|<.001
74043858|NCT03803202|147638810|OTHER||Mean Difference|0.6|||<|0.001|TWO_SIDED|95.0|0.3|0.9|||ANCOVA|||Serotype 8, Day 30||0.9|0.3|<.001
74043859|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.454|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 9N, Day 30||0.5|-0.2|0.454
74043860|NCT03803202|147638810|OTHER||Mean Difference|0.6||||0.003|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Serotype 9N, Day 30||1.0|0.2|0.003
74043861|NCT03803202|147638810|OTHER||Mean Difference|0.5||||0.021|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 9N, Day 30||0.9|0.1|0.021
74043862|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.205|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 9V, Day 30||0.6|-0.1|0.205
74043863|NCT03803202|147638810|OTHER||Mean Difference|0.5||||0.015|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 9V, Day 30||0.9|0.1|0.015
74043864|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.209|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 9V, Day 30||0.7|-0.1|0.209
74043865|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.502|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Serotype 10A, Day 30||0.6|-0.3|0.502
74043866|NCT03803202|147638810|OTHER||Mean Difference|0.5||||0.054|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 10A, Day 30||1.0|0.0|0.054
74043867|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.19|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 10A, Day 30||0.8|-0.2|0.190
74043868|NCT03803202|147638810|OTHER||Mean Difference|0.1||||0.616|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 11A, Day 30||0.4|-0.3|0.616
74043869|NCT03803202|147638810|OTHER||Mean Difference|0.4||||0.018|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 11A, Day 30||0.8|0.1|0.018
74043870|NCT03803202|147638810|OTHER||Mean Difference|0.4||||0.056|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 11A, Day 30||0.7|0.0|0.056
74043871|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.527|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Serotype 12F, Day 30||0.7|-0.4|0.527
74014406|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2115|STANDARD_ERROR_OF_MEAN|0.1033||0.0455|TWO_SIDED|80.0|0.07751|0.3455|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.34550|0.07751|0.0455
74014407|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08114|STANDARD_ERROR_OF_MEAN|0.1087||0.4585|TWO_SIDED|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.22209|-0.0598|0.4585
74014408|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5433|STANDARD_ERROR_OF_MEAN|4.6662||0.9078|TWO_SIDED|80.0|-5.513|6.5995|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.5995|-5.513|0.9078
74014409|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1848|STANDARD_ERROR_OF_MEAN|4.7892||0.6502|TWO_SIDED|80.0|-8.403|4.0338|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.0338|-8.403|0.6502
74014410|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9029|STANDARD_ERROR_OF_MEAN|3.7234||0.809|TWO_SIDED|80.0|-5.716|3.9101|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.9101|-5.716|0.8090
74014411|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4351|STANDARD_ERROR_OF_MEAN|3.8429||0.5282|TWO_SIDED|80.0|-2.532|7.4025|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.4025|-2.532|0.5282
74014412|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|25.3231|STANDARD_ERROR_OF_MEAN|18.8604||0.1848|TWO_SIDED|80.0|0.86393|49.782|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||49.782|0.86393|0.1848
74014413|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|50.4054|STANDARD_ERROR_OF_MEAN|19.481||0.0124|TWO_SIDED|80.0|25.134|75.677|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||75.677|25.134|0.0124
74014414|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8658|STANDARD_ERROR_OF_MEAN|3.0205||0.0267|TWO_SIDED|80.0|2.9504|10.781|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||10.781|2.9504|0.0267
74043872|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.444|TWO_SIDED|95.0|-0.4|0.8|||ANCOVA|||Serotype 12F, Day 30||0.8|-0.4|0.444
74014415|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|8.0855|STANDARD_ERROR_OF_MEAN|3.1677||0.0134|TWO_SIDED|80.0|3.9787|12.192|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.192|3.9787|0.0134
74014416|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5242|STANDARD_ERROR_OF_MEAN|3.7993||0.0152|TWO_SIDED|80.0|4.5949|14.453|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||14.453|4.5949|0.0152
74014417|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|19.9806|STANDARD_ERROR_OF_MEAN|4.1501|<|0.0001|TWO_SIDED|80.0|14.602|25.359|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||25.359|14.602|<.0001
74014418|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7667|STANDARD_ERROR_OF_MEAN|2.9402||0.3516|TWO_SIDED|80.0|-6.59|1.0562|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.0562|-6.590|0.3516
74014419|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0838|STANDARD_ERROR_OF_MEAN|3.2323||0.3448|TWO_SIDED|80.0|-1.116|7.2838|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.2838|-1.116|0.3448
74043873|NCT03803202|147638810|OTHER||Mean Difference|0.0||||0.869|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Serotype 12F, Day 30||0.6|-0.5|0.869
74043874|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.305|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 14, Day 30||0.7|-0.2|0.305
74014420|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5882|STANDARD_ERROR_OF_MEAN|4.3902||0.5583|TWO_SIDED|80.0|-8.294|3.1175|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.1175|-8.294|0.5583
74014421|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6547|STANDARD_ERROR_OF_MEAN|4.7652||0.1141|TWO_SIDED|80.0|1.4717|13.838|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||13.838|1.4717|0.1141
74014422|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5882|STANDARD_ERROR_OF_MEAN|0.1903||0.0034|TWO_SIDED|80.0|-0.8356|-0.3408|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3408|-0.8356|0.0034
74014423|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1722|STANDARD_ERROR_OF_MEAN|0.2064||0.4083|TWO_SIDED|80.0|-0.4403|0.09599|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.09599|-0.4403|0.4083
74014424|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2744|STANDARD_ERROR_OF_MEAN|0.1055||0.012|TWO_SIDED|80.0|0.13746|0.41127|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.41127|0.13746|0.0120
74043875|NCT03803202|147638810|OTHER||Mean Difference|0.5||||0.046|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 14, Day 30||1.0|0.0|0.046
74014425|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1016|STANDARD_ERROR_OF_MEAN|0.1136||0.375|TWO_SIDED|80.0|-0.0457|0.24881|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.24881|-0.0457|0.3750
74014426|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4367|STANDARD_ERROR_OF_MEAN|3.9301||0.9119|TWO_SIDED|80.0|-4.665|5.5387|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5387|-4.665|0.9119
74014427|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3429|STANDARD_ERROR_OF_MEAN|4.1977||0.1367|TWO_SIDED|80.0|-11.79|-0.896|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.8960|-11.79|0.1367
74014428|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0062|STANDARD_ERROR_OF_MEAN|3.1094||0.0595|TWO_SIDED|80.0|-10.05|-1.964|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.964|-10.05|0.0595
74043876|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.299|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 14, Day 30||0.8|-0.2|0.299
74014429|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0362|STANDARD_ERROR_OF_MEAN|3.3182||0.1356|TWO_SIDED|80.0|0.72505|9.3473|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.3473|0.72505|0.1356
74014430|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1569|STANDARD_ERROR_OF_MEAN|16.2884||0.7528|TWO_SIDED|80.0|-15.99|26.303|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||26.303|-15.99|0.7528
74014431|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|67.7022|STANDARD_ERROR_OF_MEAN|17.4066||0.0003|TWO_SIDED|80.0|45.114|90.29|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||90.290|45.114|0.0003
74014432|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8582|STANDARD_ERROR_OF_MEAN|2.6389||0.2837|TWO_SIDED|80.0|-0.567|6.2835|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.2835|-0.5670|0.2837
74014433|NCT00531752|147579638|SUPERIORITY_OR_OTHER||LS Mean Difference|12.9251|STANDARD_ERROR_OF_MEAN|2.8913|<|0.0001|TWO_SIDED|80.0|9.1761|16.674|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||16.674|9.1761|<0.0001
74043877|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.14|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 15B, Day 30||0.7|-0.1|0.140
74043878|NCT03803202|147638810|OTHER||Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANCOVA|||Serotype 15B, Day 30||1.3|0.4|<.001
74043879|NCT03803202|147638810|OTHER||Mean Difference|0.6||||0.012|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 15B, Day 30||1.0|0.1|0.012
74014434|NCT00531752|147579639|SUPERIORITY_OR_OTHER||LS Mean Difference|26.8615|STANDARD_ERROR_OF_MEAN|3.9167|<|0.0001|TWO_SIDED|80.0|21.777|31.946|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||31.946|21.777|<0.0001
74014435|NCT00531752|147579639|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3455|STANDARD_ERROR_OF_MEAN|4.1817||0.3034|TWO_SIDED|80.0|-1.08|9.7713|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.7713|-1.080|0.3034
74014436|NCT00531752|147579639|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9558|STANDARD_ERROR_OF_MEAN|2.9408||0.0223|TWO_SIDED|80.0|3.132|10.78|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||10.780|3.1320|0.0223
74014437|NCT00531752|147579639|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7518|STANDARD_ERROR_OF_MEAN|3.0743||0.2284|TWO_SIDED|80.0|-0.2442|7.7479|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.7479|-0.2442|0.2284
74014438|NCT00531752|147579639|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5752|STANDARD_ERROR_OF_MEAN|3.5848||0.0201|TWO_SIDED|80.0|3.9265|13.224|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||13.224|3.9265|0.0201
74014439|NCT00531752|147579639|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0229|STANDARD_ERROR_OF_MEAN|3.8154||0.1931|TWO_SIDED|80.0|0.07753|9.9683|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.9683|0.07753|0.1931
74014440|NCT00531752|147579640|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6766|STANDARD_ERROR_OF_MEAN|0.1759||0.0003|TWO_SIDED|80.0|-0.9046|-0.4487|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.4487|-0.9046|0.0003
74014441|NCT00531752|147579640|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3075|STANDARD_ERROR_OF_MEAN|0.1871||0.1055|TWO_SIDED|80.0|-0.5499|-0.065|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0650|-0.5499|0.1055
74014442|NCT00531752|147579640|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4684|STANDARD_ERROR_OF_MEAN|0.1791||0.0119|TWO_SIDED|80.0|-0.7012|-0.2356|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.2356|-0.7012|0.0119
74014443|NCT00531752|147579640|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1263|STANDARD_ERROR_OF_MEAN|0.1866||0.5016|TWO_SIDED|80.0|-0.3687|0.11608|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.11608|-0.3687|0.5016
74014444|NCT00531752|147579640|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3451|STANDARD_ERROR_OF_MEAN|0.1738||0.0531|TWO_SIDED|80.0|-0.5711|-0.1191|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.1191|-0.5711|0.0531
74014445|NCT00531752|147579640|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4137|STANDARD_ERROR_OF_MEAN|0.1856||0.0306|TWO_SIDED|80.0|-0.6549|-0.1725|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.1725|-0.6549|0.0306
74014446|NCT00531752|147579641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7671|STANDARD_ERROR_OF_MEAN|0.1731|<|0.0001|TWO_SIDED|80.0|0.5426|0.99157|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.99157|0.54260|<0.0001
74014447|NCT00531752|147579641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5285|STANDARD_ERROR_OF_MEAN|0.1847||0.0059|TWO_SIDED|80.0|0.28911|0.76798|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.76798|0.28911|0.0059
74043880|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.2|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.1|0.200
74043881|NCT03803202|147638810|OTHER||Mean Difference|0.4||||0.037|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 17F, Day 30||0.8|0.0|0.037
74043882|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.38|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.2|0.380
74043883|NCT03803202|147638810|OTHER||Mean Difference|0.6||||0.006|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Serotype 18C, Day 30||1.0|0.2|0.006
74043884|NCT03803202|147638810|OTHER||Mean Difference|0.5||||0.018|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 18C, Day 30||1.0|0.1|0.018
74043885|NCT03803202|147638810|OTHER||Mean Difference|-0.1||||0.81|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 18C, Day 30||0.4|-0.5|0.810
74043886|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.173|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19A, Day 30||0.7|-0.1|0.173
74043887|NCT03803202|147638810|OTHER||Mean Difference|0.4||||0.096|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 19A, Day 30||0.8|-0.1|0.096
74043888|NCT03803202|147638810|OTHER||Mean Difference|0.1||||0.71|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.3|0.710
74043889|NCT03803202|147638810|OTHER||Mean Difference|0.4||||0.1|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 19F, Day 30||0.8|-0.1|0.100
74043890|NCT03803202|147638810|OTHER||Mean Difference|0.6||||0.007|TWO_SIDED|95.0|0.2|1.1|||ANCOVA|||Serotype 19F, Day 30||1.1|0.2|0.007
74043891|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.251|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.2|0.251
74043892|NCT03803202|147638810|OTHER||Mean Difference|0.1||||0.618|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 20B, Day 30||0.5|-0.3|0.618
74043893|NCT03803202|147638810|OTHER||Mean Difference|0.5||||0.041|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Serotype 20B, Day 30||0.9|0.0|0.041
74014448|NCT00531752|147579641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1526|STANDARD_ERROR_OF_MEAN|0.1431||0.2921|TWO_SIDED|80.0|-0.0336|0.33878|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.33878|-0.0336|0.2921
74014449|NCT00531752|147579641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.198|STANDARD_ERROR_OF_MEAN|0.1498||0.1929|TWO_SIDED|80.0|0.00319|0.39272|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.39272|0.00319|0.1929
74014450|NCT00531752|147579641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3433|STANDARD_ERROR_OF_MEAN|0.1565||0.0332|TWO_SIDED|80.0|0.13988|0.54663|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.54663|0.13988|0.0332
74014451|NCT00531752|147579641|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4184|STANDARD_ERROR_OF_MEAN|0.1681||0.0162|TWO_SIDED|80.0|0.20006|0.63674|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.63674|0.20006|0.0162
74014452|NCT00531752|147579642|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5103|STANDARD_ERROR_OF_MEAN|0.1103|<|0.0001|TWO_SIDED|80.0|0.36707|0.65345|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.65345|0.36707|<0.0001
74014453|NCT00531752|147579642|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3643|STANDARD_ERROR_OF_MEAN|0.1174||0.0031|TWO_SIDED|80.0|0.21189|0.51664|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.51664|0.21189|0.0031
74014454|NCT00531752|147579642|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1362|STANDARD_ERROR_OF_MEAN|0.09408||0.1553|TWO_SIDED|80.0|0.01366|0.25882|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.25882|0.01366|0.1553
74014455|NCT00531752|147579642|SUPERIORITY_OR_OTHER||LS Mean Difference|0.107|STANDARD_ERROR_OF_MEAN|0.09797||0.2809|TWO_SIDED|80.0|-0.0205|0.23458|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.23458|-0.0205|0.2809
74014456|NCT00531752|147579642|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2195|STANDARD_ERROR_OF_MEAN|0.1146||0.0603|TWO_SIDED|80.0|0.07101|0.36803|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.36803|0.07101|0.0603
74014457|NCT00531752|147579642|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4278|STANDARD_ERROR_OF_MEAN|0.1212||0.0008|TWO_SIDED|80.0|0.27079|0.58479|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.58479|0.27079|0.0008
74014458|NCT00531752|147579643|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.3264|STANDARD_ERROR_OF_MEAN|2.6944|<|0.0001|TWO_SIDED|80.0|-16.83|-9.828|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-9.828|-16.83|<0.0001
74043894|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.111|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 20B, Day 30||0.8|-0.1|0.111
74043895|NCT03803202|147638810|OTHER||Mean Difference|0.1||||0.758|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 22F, Day 30||0.4|-0.3|0.758
74014459|NCT00531752|147579643|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.126|STANDARD_ERROR_OF_MEAN|2.8841||0.0068|TWO_SIDED|80.0|-11.87|-4.382|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-4.382|-11.87|0.0068
74014460|NCT00531752|147579643|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5341|STANDARD_ERROR_OF_MEAN|2.3172||0.1346|TWO_SIDED|80.0|-6.551|-0.5175|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.5175|-6.551|0.1346
74014461|NCT00531752|147579643|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0911|STANDARD_ERROR_OF_MEAN|2.4268||0.6552|TWO_SIDED|80.0|-2.067|4.2494|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2494|-2.067|0.6552
74014462|NCT00531752|147579643|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2001|STANDARD_ERROR_OF_MEAN|1.7614||0.0765|TWO_SIDED|80.0|-5.494|-0.9063|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.9063|-5.494|0.0765
74014463|NCT00531752|147579643|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8781|STANDARD_ERROR_OF_MEAN|1.8976||0.0473|TWO_SIDED|80.0|-6.349|-1.407|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.407|-6.349|0.0473
74014464|NCT00950664|147579649|NON_INFERIORITY_OR_EQUIVALENCE|81 participants required to detect 5 difference in Tsui score, with 80% power. 20% drop out rate assumed, 102 participants needed. Alpha level of 0.05.||||||0.05||95.0|||||Paired-t test|||||||0.05
74014465|NCT00159861|147579670|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.095|||||TWO_SIDED|95.0|0.059|0.132||||||1 Year: Proportion of participants who died.||0.132|0.059|
74014466|NCT00159861|147579670|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.194|||||TWO_SIDED|95.0|0.144|0.243||||||2 Years: Proportion of participants who died.||0.243|0.144|
74043896|NCT03803202|147638810|OTHER||Mean Difference|0.5||||0.012|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 22F, Day 30||0.9|0.1|0.012
74043897|NCT03803202|147638810|OTHER||Mean Difference|0.4||||0.025|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 22F, Day 30||0.8|0.1|0.025
74043898|NCT03803202|147638810|OTHER||Mean Difference|0.0||||0.912|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 23F, Day 30||0.4|-0.5|0.912
73880114|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.38||||0.1355|TWO_SIDED|95.0|0.76|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.42|0.76|0.1355
73880115|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|5.17||||0.0028|TWO_SIDED|95.0|1.76|15.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.14|1.76|0.0028
73880116|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.2||||0.7422|TWO_SIDED|95.0|0.41|3.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.47|0.41|0.7422
73880117|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.44||||0.075|TWO_SIDED|95.0|0.91|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.52|0.91|0.0750
73880118|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0006|TWO_SIDED|95.0|2.16|16.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.67|2.16|0.0006
73880119|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|7.63||||0.0001|TWO_SIDED|95.0|2.69|21.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||21.65|2.69|0.0001
73880120|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8405|TWO_SIDED|95.0|0.38|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.23|0.38|0.8405
73880121|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6257|TWO_SIDED|95.0|0.45|3.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.79|0.45|0.6257
73880122|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|3.92||||0.006|TWO_SIDED|95.0|1.48|10.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.36|1.48|0.0060
73880123|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.74||||0.3556|TWO_SIDED|95.0|0.54|5.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.68|0.54|0.3556
74094883|NCT02912650|147740350|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.176|TWO_SIDED|95.0|-0.06|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|-0.06|0.176
73880124|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|3.67||||0.019|TWO_SIDED|95.0|1.24|10.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.90|1.24|0.0190
74043899|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.174|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.1|0.174
74043900|NCT03803202|147638810|OTHER||Mean Difference|0.3||||0.138|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.1|0.138
74043901|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.267|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 33F, Day 30||0.7|-0.2|0.267
74043902|NCT03803202|147638810|OTHER||Mean Difference|0.2||||0.3|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 33F, Day 30||0.7|-0.2|0.300
73880125|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|9.9|||<|0.0001|TWO_SIDED|95.0|3.2|30.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||30.68|3.20|<0.0001
73880126|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|14.81|||<|0.0001|TWO_SIDED|95.0|4.67|47.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||47.05|4.67|<0.0001
73880127|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1936|TWO_SIDED|95.0|0.68|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|0.68|0.1936
74043903|NCT03803202|147638810|OTHER||Mean Difference|0.0||||0.982|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 33F, Day 30||0.4|-0.4|0.982
74043904|NCT03803202|147638811|OTHER||Ratio of GMT|1.49|||||TWO_SIDED|95.0|1.06|2.08|||t-test, 2 sided|||Serotype 2||2.08|1.06|
74043905|NCT03803202|147638811|OTHER||Ratio of GMT|0.97|||||TWO_SIDED|95.0|0.68|1.37|||t-test, 2 sided|||Serotype 8||1.37|0.68|
74043906|NCT03803202|147638811|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.92|2.0|||t-test, 2 sided|||Serotype 9N||2.00|0.92|
74043907|NCT03803202|147638811|OTHER||Ratio of GMT|2.18|||||TWO_SIDED|95.0|1.25|3.79|||t-test, 2 sided|||Serotype 10A||3.79|1.25|
74043908|NCT03803202|147638811|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.8|1.77|||t-test, 2 sided|||Serotype 11A||1.77|0.80|
73880128|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0335|TWO_SIDED|95.0|1.1|10.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.47|1.10|0.0335
74014467|NCT00159861|147579670|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.26|||||TWO_SIDED|95.0|0.205|0.315||||||3 Years: Proportion of participants who died.||0.315|0.205|
74014468|NCT00159861|147579670|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.291|||||TWO_SIDED|95.0|0.234|0.348||||||4 Years: Proportion of participants who died.||0.348|0.234|
73880129|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|6.18||||0.0009|TWO_SIDED|95.0|2.1|18.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||18.17|2.10|0.0009
74014469|NCT00159861|147579670|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.369|||||TWO_SIDED|95.0|0.302|0.437||||||5 Years: Proportion of participants who died.||0.437|0.302|
74014470|NCT03829657|147579705|SUPERIORITY||Odds Ratio (OR)|0.6||||0.196|TWO_SIDED|95.0|0.27|1.29|||Regression, Logistic|||||1.29|0.27|0.196
74014471|NCT00609791|147579708|SUPERIORITY||Slope|0.011|STANDARD_ERROR_OF_MEAN|0.0057||0.055|TWO_SIDED||||||Regression, Linear|||Linear regression of ln AUC24 on age in years||||0.055
74043909|NCT03803202|147638811|OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.73|2.0|||t-test, 2 sided|||Serotype 12F||2.00|0.73|
74043910|NCT03803202|147638811|OTHER||Ratio of GMT|1.47|||||TWO_SIDED|95.0|0.94|2.29|||t-test, 2 sided|||Serotype 15B||2.29|0.94|
74043911|NCT03803202|147638811|OTHER||Ratio of GMT|2.61|||||TWO_SIDED|95.0|1.68|4.04|||t-test, 2 sided|||Serotype 17F||4.04|1.68|
74043912|NCT03803202|147638811|OTHER||Ratio of GMT|9.05|||||TWO_SIDED|95.0|5.65|14.5|||t-test, 2 sided|||Serotype 20B||14.50|5.65|
74043913|NCT03803202|147638811|OTHER||Ratio of GMT|1.79|||||TWO_SIDED|95.0|1.09|2.95|||t-test, 2 sided|||Serotype 22F||2.95|1.09|
74043914|NCT03803202|147638811|OTHER|Serotype 33F|Ratio of GMT|1.34|||||TWO_SIDED|95.0|0.86|2.11|||t-test, 2 sided|||||2.11|0.86|
74043915|NCT03803202|147638811|OTHER||Ratio of GMT|1.31|||||TWO_SIDED|95.0|0.93|1.83|||t-test, 2 sided|||Serotype 2||1.83|0.93|
74043916|NCT03803202|147638811|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.67|1.43|||t-test, 2 sided|||Serotype 8||1.43|0.67|
74043917|NCT03803202|147638811|OTHER||Ratio of GMT|1.62|||||TWO_SIDED|95.0|1.62|2.26|||t-test, 2 sided|||Serotype 9N||2.26|1.62|
74043918|NCT03803202|147638811|OTHER||Ratio of GMT|2.87|||||TWO_SIDED|95.0|1.68|4.9|||t-test, 2 sided|||Serotype 10A||4.90|1.68|
74043919|NCT03803202|147638811|OTHER||Ratio of GMT|1.42|||||TWO_SIDED|95.0|0.98|2.06|||t-test, 2 sided|||Serotype 11A||2.06|0.98|
74043920|NCT03803202|147638811|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.54|1.48|||t-test, 2 sided|||Serotype 12F||1.48|0.54|
74014472|NCT00609791|147579708|SUPERIORITY||Slope|1.17|STANDARD_ERROR_OF_MEAN|0.45||0.013|TWO_SIDED||||||Regression, Linear|||Linear regression of ln AUC24 on chemotherapy toxicity risk score||||0.013
74014473|NCT00609791|147579709|SUPERIORITY||Slope|-0.0074|STANDARD_ERROR_OF_MEAN|0.0063||0.25|TWO_SIDED||||||Regression, Linear|||Linear regression of ln CL on age in years||||0.25
74014474|NCT00609791|147579709|SUPERIORITY||Slope|-0.96|STANDARD_ERROR_OF_MEAN|0.44||0.04|TWO_SIDED||||||Regression, Linear|||Linear regression of ln CL versus chemotherapy toxicity risk score||||0.04
74014475|NCT00609791|147579710|OTHER|||||||0.041|||||||Fisher Exact|||||||0.041
74043921|NCT03803202|147638811|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.73|1.64|||t-test, 2 sided|||Serotype 15B||1.64|0.73|
74043922|NCT03803202|147638811|OTHER||Ratio of GMT|2.13|||||TWO_SIDED|95.0|1.4|3.25|||t-test, 2 sided|||Serotype 17F||3.25|1.40|
74043923|NCT03803202|147638811|OTHER||Ratio of GMT|7.28|||||TWO_SIDED|95.0|4.61|11.5|||t-test, 2 sided|||Serotype 20B||11.50|4.61|
74043924|NCT03803202|147638811|OTHER||Ratio of GMT|1.55|||||TWO_SIDED|95.0|0.96|2.48|||t-test, 2 sided|||Serotype 22F||2.48|0.96|
74043925|NCT03803202|147638811|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.83|1.84|||t-test, 2 sided|||Serotype 33F||1.84|0.83|
74043926|NCT03803202|147638811|OTHER||Ratio of GMT|2.1|||||TWO_SIDED|95.0|1.51|2.94|||t-test, 2 sided|||Serotype 2||2.94|1.51|
74043927|NCT03803202|147638811|OTHER||Ratio of GMT|2.08|||||TWO_SIDED|95.0|1.46|2.97|||t-test, 2 sided|||Serotype 8||2.97|1.46|
74043928|NCT03803202|147638811|OTHER||Ratio of GMT|2.24|||||TWO_SIDED|95.0|1.56|3.2|||t-test, 2 sided|||Serotype 9N||3.20|1.56|
74043929|NCT03803202|147638811|OTHER||Ratio of GMT|3.24|||||TWO_SIDED|95.0|1.79|5.89|||t-test, 2 sided|||Serotype 10A||5.89|1.79|
74043930|NCT03803202|147638811|OTHER||Ratio of GMT|2.43|||||TWO_SIDED|95.0|1.63|3.62|||t-test, 2 sided|||Serotype 11A||3.62|1.63|
74043931|NCT03803202|147638811|OTHER||Ratio of GMT|1.51|||||TWO_SIDED|95.0|0.89|2.55|||t-test, 2 sided|||Serotype 12 F||2.55|0.89|
74043932|NCT03803202|147638811|OTHER||Ratio of GMT|1.69|||||TWO_SIDED|95.0|1.11|2.57|||t-test, 2 sided|||Serotype 15B||2.57|1.11|
74043933|NCT03803202|147638811|OTHER||Ratio of GMT|3.37|||||TWO_SIDED|95.0|2.18|5.2|||t-test, 2 sided|||Serotype 17F||5.20|2.18|
74043934|NCT03803202|147638811|OTHER||Ratio of GMT|13.7|||||TWO_SIDED|95.0|8.26|22.72|||t-test, 2 sided|||Serotype 20B||22.72|8.26|
74043935|NCT03803202|147638811|OTHER||Ratio of GMT|2.17|||||TWO_SIDED|95.0|1.36|3.46|||t-test, 2 sided|||Serotype 22F||3.46|1.36|
74043936|NCT03803202|147638811|OTHER||Ratio of GMT|1.69|||||TWO_SIDED|95.0|1.11|2.57|||t-test, 2 sided|||Serotype 33F||2.57|1.11|
74043937|NCT03803202|147638812|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.95|1.93|||t-test, 2 sided|||Serotype 2||1.93|0.95|
74043938|NCT03803202|147638812|OTHER||Ratio of GMT|1.51|||||TWO_SIDED|95.0|1.07|2.13|||t-test, 2 sided|||Serotype 8||2.13|1.07|
74043939|NCT03803202|147638812|OTHER||Ratio of GMT|1.59|||||TWO_SIDED|95.0|1.09|2.33|||t-test, 2 sided|||Serotype 9N||2.33|1.09|
74043940|NCT03803202|147638812|OTHER||Ratio of GMT|2.24|||||TWO_SIDED|95.0|1.45|3.47|||t-test, 2 sided|||Serotype 10A||3.47|1.45|
74043941|NCT03803202|147638812|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|1.27|2.65|||t-test, 2 sided|||Serotype 11A||2.65|1.27|
73880130|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.9||||0.833|TWO_SIDED|95.0|0.34|2.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.39|0.34|0.8330
73880131|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.56||||0.341|TWO_SIDED|95.0|0.62|3.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.91|0.62|0.3410
74014476|NCT00609791|147579713|SUPERIORITY||Mean Difference (Final Values)|-4.89||||0.38|TWO_SIDED|95.0|-16.5|6.7|||t-test, 2 sided|||Difference in age based on whether there was need for a dose reduction.||6.7|-16.5|.38
74014477|NCT00609791|147579713|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.76|TWO_SIDED|95.0|-0.33|0.44|||t-test, 2 sided|||Difference in AUC24 based on the need of a dose reduction.||0.44|-0.33|0.76
74014478|NCT00609791|147579713|SUPERIORITY||Mean Difference (Final Values)|-0.063||||0.75|TWO_SIDED|95.0|-0.49|0.36|||t-test, 2 sided|||Difference in clearance based on whether there was a need for dose reduction.||0.36|-0.49|0.75
74014479|NCT00609791|147579714|SUPERIORITY||Mean Difference (Final Values)|5.81||||0.15|TWO_SIDED|95.0|-2.3|13.9|||t-test, 2 sided|||Difference in age based on whether there was need for a dose omission.||13.9|-2.3|0.15
74014480|NCT00609791|147579714|SUPERIORITY||Mean Difference (Final Values)|-0.079||||0.61|TWO_SIDED|95.0|-0.39|0.23|||t-test, 2 sided|||Difference in AUC24 based on whether there was need for a dose omission.||0.23|-0.39|0.61
74043942|NCT03803202|147638812|OTHER||Ratio of GMT|1.31|||||TWO_SIDED|95.0|0.77|2.23|||t-test, 2 sided|||Serotype 12F||2.23|0.77|
74043943|NCT03803202|147638812|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.8|1.91|||t-test, 2 sided|||Serotype 15B||1.91|0.80|
74043944|NCT03803202|147638812|OTHER||Ratio of GMT|2.63|||||TWO_SIDED|95.0|1.7|4.07|||t-test, 2 sided|||Serotype 17F||4.07|1.70|
74043945|NCT03803202|147638812|OTHER||Ratio of GMT|2.43|||||TWO_SIDED|95.0|1.61|3.67|||t-test, 2 sided|||Serotype 20B||3.67|1.61|
74043946|NCT03803202|147638812|OTHER||Ratio of GMT|2.49|||||TWO_SIDED|95.0|1.7|3.65|||t-test, 2 sided|||Serotype 22F||3.65|1.70|
74043947|NCT03803202|147638812|OTHER||Ratio of GMT|1.67|||||TWO_SIDED|95.0|1.1|2.54|||t-test, 2 sided|||Serotype 33F||2.54|1.10|
74043948|NCT03803202|147638812|OTHER||Ratio of GMT|1.42|||||TWO_SIDED|95.0|0.98|2.07|||t-test, 2 sided|||Serotype 2||2.07|0.98|
74043949|NCT03803202|147638812|OTHER||Ratio of GMT|1.58|||||TWO_SIDED|95.0|1.11|2.26|||t-test, 2 sided|||Serotype 8||2.26|1.11|
74043950|NCT03803202|147638812|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|1.23|2.72|||t-test, 2 sided|||Serotype 9N||2.72|1.23|
74043951|NCT03803202|147638812|OTHER||Ratio of GMT|2.59|||||TWO_SIDED|95.0|1.66|4.05||||||Serotype 10A||4.05|1.66|
74014481|NCT00609791|147579714|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.51|TWO_SIDED|95.0|-0.22|0.42|||t-test, 2 sided|||Difference in clearance based on whether there was a need for a dose omission.||0.42|-0.22|0.51
74014482|NCT00609791|147579715|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.75|TWO_SIDED|95.0|-9.3|12.7|||t-test, 2 sided|||Difference in age based on whether a participant experienced grade 3 toxicity.||12.7|-9.3|0.75
74014483|NCT00609791|147579715|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.13|TWO_SIDED|95.0|-0.12|0.81|||t-test, 2 sided|||Difference in AUC based on whether a participant experienced grade 3 toxicity.||0.81|-0.12|0.13
74014484|NCT00609791|147579715|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.34|TWO_SIDED|95.0|-0.67|0.25|||t-test, 2 sided|||Difference in clearance based on whether a participant experienced grade 3 toxicity.||0.25|-0.67|0.34
74014485|NCT00150592|147579730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.844||95.0|||||ANCOVA|||||||0.844
74014486|NCT00150592|147579731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274||95.0|||||ANCOVA|Mean reaction time (adjusted) for each randomized treatment group at endpoint.||||||0.274
74014487|NCT00150592|147579733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.307||95.0|||||ANCOVA|||Between errors||||0.307
74014488|NCT00150592|147579733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552||95.0|||||ANCOVA|||Within errors||||0.552
74014489|NCT00150592|147579733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.917||95.0|||||ANCOVA|||Double errors||||0.917
74014490|NCT00150592|147579733|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068||95.0|||||ANCOVA|||Strategy||||0.068
74043952|NCT03803202|147638812|OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.32|2.73|||t-test, 2 sided|||Serotype 11A||2.73|1.32|
74043953|NCT03803202|147638812|OTHER||Ratio of GMT|1.59|||||TWO_SIDED|95.0|0.93|2.71|||t-test, 2 sided|||Serotype 12F||2.71|0.93|
74043954|NCT03803202|147638812|OTHER||Ratio of GMT|1.68|||||TWO_SIDED|95.0|1.11|2.53|||t-test, 2 sided|||Serotype 15B||2.53|1.11|
74043955|NCT03803202|147638812|OTHER||Ratio of GMT|3.27|||||TWO_SIDED|95.0|2.17|4.93|||t-test, 2 sided|||Serotype 17F||4.93|2.17|
74043956|NCT03803202|147638812|OTHER||Ratio of GMT|2.79|||||TWO_SIDED|95.0|1.85|4.22|||t-test, 2 sided|||Serotype 20B||4.22|1.85|
74043957|NCT03803202|147638812|OTHER||Ratio of GMT|2.63|||||TWO_SIDED|95.0|1.79|3.88|||t-test, 2 sided|||Serotype 22F||3.88|1.79|
74043958|NCT03803202|147638812|OTHER||Ratio of GMT|2.05|||||TWO_SIDED|95.0|1.4|3.01|||t-test, 2 sided|||Serotype 33F||3.01|1.40|
74043959|NCT03803202|147638812|OTHER||Ratio of GMT|1.97|||||TWO_SIDED|95.0|1.37|2.84|||t-test, 2 sided|||Serotype 2||2.84|1.37|
74043960|NCT03803202|147638812|OTHER||Ratio of GMT|2.98|||||TWO_SIDED|95.0|2.12|4.18|||t-test, 2 sided|||Serotype 8||4.18|2.12|
74043961|NCT03803202|147638812|OTHER||Ratio of GMT|2.99|||||TWO_SIDED|95.0|2.02|4.44|||t-test, 2 sided|||Serotype 9N||4.44|2.02|
74043962|NCT03803202|147638812|OTHER||Ratio of GMT|3.63|||||TWO_SIDED|95.0|2.25|5.86|||t-test, 2 sided|||Serotype 10A||5.86|2.25|
74043963|NCT03803202|147638812|OTHER||Ratio of GMT|2.86|||||TWO_SIDED|95.0|1.96|4.18|||t-test, 2 sided|||Serotype 11A||4.18|1.96|
74043964|NCT03803202|147638812|OTHER||Ratio of GMT|1.64|||||TWO_SIDED|95.0|0.91|2.96|||t-test, 2 sided|||Serotype 12F||2.96|0.91|
74043965|NCT03803202|147638812|OTHER||Ratio of GMT|2.93|||||TWO_SIDED|95.0|1.87|4.61|||t-test, 2 sided|||Serotype 15B||4.61|1.87|
74043966|NCT03803202|147638812|OTHER||Ratio of GMT|4.0|||||TWO_SIDED|95.0|2.55|6.26|||t-test, 2 sided|||Serotype 17F||6.26|2.55|
74043967|NCT03803202|147638812|OTHER||Ratio of GMT|3.82|||||TWO_SIDED|95.0|2.46|5.91|||t-test, 2 sided|||Serotype 22F||5.91|2.46|
74043968|NCT03803202|147638812|OTHER||Ratio of GMT|4.02|||||TWO_SIDED|95.0|2.74|5.9|||t-test, 2 sided|||Serotype 22F||5.90|2.74|
73880132|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0075|TWO_SIDED|95.0|1.42|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.69|1.42|0.0075
73880133|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|4.86||||0.002|TWO_SIDED|95.0|1.78|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.26|1.78|0.0020
73880134|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.78||||0.6216|TWO_SIDED|95.0|0.29|2.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.10|0.29|0.6216
74014491|NCT00150592|147579734|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.001
74014492|NCT00150592|147579735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Cochran-Mantel-Haenszel|||||||0.007
74014493|NCT00150592|147579736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||ANCOVA|||||||0.02
74014494|NCT00150592|147579737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231||95.0|||||ANCOVA|||||||0.231
74014495|NCT02227693|147579738|OTHER||Difference of responder rate vs. placebo|19.5||||0.146|TWO_SIDED|95.0|-18.1|57.0|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||57.0|-18.1|0.146
74043969|NCT03803202|147638812|OTHER||Ratio of GMT|2.11|||||TWO_SIDED|95.0|1.38|3.23|||t-test, 2 sided|||Serotype 33F||3.23|1.38|
74043970|NCT00293241|147638813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.72|TWO_SIDED|95.0|0.612|1.405|||Log Rank||"Hospitalization:hospital admission with overnight stay;ER/office visits with cardioversions;acute treatment of worsened cardiac condition~CV:new/worsening HF,angina,MI,arrhythmia,stroke, TIA,acute peripheral vascular emergencies,pulmonary embolism"|"Analysis:Time to first cardiovascular hospitalization (CV hosp)~H0:freedom from CV hosp MVP=freedom from CV hosp DDD (dual chamber conventional pacing)~Ha:freedom from CV hosp MVP≠freedom from CV hosp DDD~Power calculation:~The study is designed to detect a difference event-free survival after 2 years of 5.5 % absolute, going from 91.5% to 97%.~Test=two-sided alpha=0.05 power=80% 1:1 randomization n=600"||1.405|0.612|0.72
74043971|NCT00293241|147638814|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.127||||0.48|TWO_SIDED|95.0|0.808|1.57|||Log Rank|||"Analysis:Time to first all cause death or cardiovascular hospitalization~H0:freedom from death or CV hospitalization=freedom from death or CV hospitalization~Ha:freedom from death or CV hospitalization≠freedom from death or CV hospitalization"||1.570|0.808|0.48
74043972|NCT00293241|147638815|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.521||||0.08|TWO_SIDED|95.0|0.954|2.424|||Log Rank|||Analysis:Time to first persistent AT/AF H0:freedom from persistent AT/AF=freedom from persistent AT/AF Ha:freedom from persistent AT/AF≠freedom from persistent AT/AF||2.424|0.954|0.08
74014496|NCT02227693|147579738|OTHER||Difference of responder rate vs. placebo|54.5||||0.004|TWO_SIDED|95.0|21.4|87.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||87.7|21.4|0.004
74014497|NCT02227693|147579738|OTHER||Difference of responder rate vs. placebo|30.9||||0.024|TWO_SIDED|95.0|-3.9|65.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||65.7|-3.9|0.024
74014498|NCT02227693|147579739|OTHER||Difference of proportion vs. placebo|14.3||||0.388|TWO_SIDED|95.0|-11.6|40.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)||40.2|-11.6|0.388
74014499|NCT02227693|147579739|OTHER||Difference of proportion vs. placebo|27.3||||0.214|TWO_SIDED|95.0|1.0|53.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)||53.6|1.0|0.214
74014500|NCT02227693|147579739|OTHER||Difference of proportion vs. placebo|62.3||||0.012|TWO_SIDED|95.0|24.8|99.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||99.9|24.8|0.012
74014501|NCT02227693|147579739|OTHER||Difference of proportion vs. placebo|72.7||||0.001|TWO_SIDED|95.0|44.3|100.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||100.0|44.3|0.001
74014502|NCT02227693|147579739|OTHER||Difference of proportion vs. placebo|40.9||||0.063|TWO_SIDED|95.0|5.6|76.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||76.2|5.6|0.063
74014503|NCT02227693|147579739|OTHER||Difference of proportion vs. placebo|-27.3||||0.245|TWO_SIDED|95.0|-53.6|-1.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||-1.0|-53.6|0.245
74014504|NCT02227693|147579739|OTHER||Difference of proportion vs. placebo|27.3||||0.386|TWO_SIDED|95.0|-12.2|66.8||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||66.8|-12.2|0.386
74094884|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.002|TWO_SIDED|95.0|0.18|0.77|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.77|0.18|0.002
74094885|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.098|TWO_SIDED|95.0|-0.03|0.38|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.38|-0.03|0.098
74094886|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.719|TWO_SIDED|95.0|-0.25|0.17|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.17|-0.25|0.719
74094887|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.048|TWO_SIDED|95.0|0.0|0.6|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.60|0.00|0.048
74094888|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|||<|0.001|TWO_SIDED|95.0|0.21|0.81|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.81|0.21|<0.001
74094889|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.046|TWO_SIDED|95.0|-0.42|0.0|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||-0.00|-0.42|0.046
74094890|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.52|||<|0.001|TWO_SIDED|95.0|1.05|1.99|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.99|1.05|<0.001
73880135|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.43||||0.4615|TWO_SIDED|95.0|0.55|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.71|0.55|0.4615
73880136|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0281|TWO_SIDED|95.0|1.12|7.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.19|1.12|0.0281
73880137|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8028|TWO_SIDED|95.0|0.33|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.35|0.33|0.8028
74094891|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.069|TWO_SIDED|95.0|-0.02|0.63|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.63|-0.02|0.069
74094892|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.604|TWO_SIDED|95.0|-0.24|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|-0.24|0.604
74094893|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|||<|0.001|TWO_SIDED|95.0|0.75|1.69|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.75|<0.001
74094894|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|||<|0.001|TWO_SIDED|95.0|0.96|1.9|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.90|0.96|<0.001
74094895|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.2|TWO_SIDED|95.0|-0.54|0.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.11|-0.54|0.200
74094896|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.89|||<|0.001|TWO_SIDED|95.0|2.32|3.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.46|2.32|<0.001
74094897|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.002|TWO_SIDED|95.0|0.23|1.03|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.03|0.23|0.002
74094898|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55||||0.008|TWO_SIDED|95.0|0.14|0.95|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.95|0.14|0.008
74094899|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.69|2.83|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.83|1.69|<0.001
74094900|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.34|||<|0.001|TWO_SIDED|95.0|1.77|2.91|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.91|1.77|<0.001
74094901|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.685|TWO_SIDED|95.0|-0.49|0.32|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|-0.49|0.685
74094902|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|3.35|||<|0.001|TWO_SIDED|95.0|2.77|3.93|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.93|2.77|<0.001
74094903|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.001|TWO_SIDED|95.0|0.26|1.07|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.07|0.26|0.001
74094904|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.57|1.39|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.39|0.57|<0.001
74094905|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.69|||<|0.001|TWO_SIDED|95.0|2.11|3.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.27|2.11|<0.001
74094906|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.37|||<|0.001|TWO_SIDED|95.0|1.79|2.96|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.96|1.79|<0.001
74014505|NCT02227693|147579739|OTHER||Difference of proportion vs. placebo|-7.3||||1|TWO_SIDED|95.0|-43.4|28.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||28.9|-43.4|1.000
74014506|NCT02227693|147579739|OTHER||Difference of proportion vs. placebo|-18.2||||0.496|TWO_SIDED|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||4.6|-41.0|0.496
74014507|NCT02227693|147579739|OTHER||Difference of proportion vs. placebo|-9.1||||1|TWO_SIDED|95.0|-37.5|19.3||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||19.3|-37.5|1.000
74014508|NCT02227693|147579739|OTHER||Difference of proportion vs. placebo|-18.2||||0.476|TWO_SIDED|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||4.6|-41.0|0.476
74014509|NCT02227693|147579740|OTHER||Difference of proportion vs. placebo|63.6||||0.003|TWO_SIDED|95.0|35.2|92.1||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||92.1|35.2|0.003
74014510|NCT02227693|147579740|OTHER||Difference of proportion vs. placebo|30.0||||0.09|TWO_SIDED|95.0|1.6|58.4||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||58.4|1.6|0.090
74014511|NCT02227693|147579740|OTHER||Difference of proportion vs. placebo|10.0||||0.476|TWO_SIDED|95.0|-8.6|28.6||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||28.6|-8.6|0.476
74014512|NCT02227693|147579743|OTHER|||||||0.296||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.296
74014513|NCT02227693|147579743|OTHER|||||||0.07||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.070
74014514|NCT02227693|147579743|OTHER|||||||0.138||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.138
74014515|NCT02227693|147579743|OTHER|||||||0.012||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.012
74014516|NCT02227693|147579743|OTHER|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.001
74014517|NCT02227693|147579743|OTHER|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.001
74043973|NCT00293241|147638816|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.425||||0.44|TWO_SIDED|95.0|0.573|3.543|||Log Rank|||Analysis:Time to permanent AF H0:freedom from permanent AF=freedom from permanent AF Ha:freedom from permanent AF≠freedom from permanent AF||3.543|0.573|0.44
74014518|NCT02227693|147579743|OTHER|||||||0.624||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.624
74014519|NCT02227693|147579743|OTHER|||||||0.009||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.009
74014520|NCT02227693|147579743|OTHER|||||||0.01||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.010
74014521|NCT02227693|147579743|OTHER|||||||0.154||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.154
74014522|NCT02227693|147579743|OTHER|||||||0.216||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.216
74014523|NCT02227693|147579743|OTHER|||||||0.901||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.901
74014524|NCT00874120|147579750|SUPERIORITY_OR_OTHER||residual error term from the ANOVA|-0.5||||0.548|TWO_SIDED|95.0|-2.0|1.1||P-value is based on an ANOVA model including sequence, subject within sequence, period and treatment as factors.|ANOVA|||||1.1|-2.0|0.5480
74014525|NCT01877187|147579783|OTHER|||||||0.06||||||Statistical significance defined as p \<= .05. Result is for Day 30 timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||.06
74014526|NCT01877187|147579783|OTHER|||||||0.09||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||.09
74014527|NCT01877187|147579783|OTHER|||||||0.034||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.034
74014528|NCT01877187|147579785|OTHER|||||||0.19||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.19
74014529|NCT01877187|147579785|OTHER|||||||0.011||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.011
74014530|NCT01877187|147579785|OTHER|||||||0.94||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.94
74014531|NCT01877187|147579787|OTHER|||||||0.06||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.06
74014532|NCT01877187|147579787|OTHER|||||||0.017||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.017
74014533|NCT01877187|147579787|OTHER|||||||0.08||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.08
74094907|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.132|TWO_SIDED|95.0|-0.1|0.73|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|-0.10|0.132
73880138|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.21||||0.6846|TWO_SIDED|95.0|0.48|3.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.07|0.48|0.6846
74014534|NCT01877187|147579789|OTHER|||||||0.02||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.020
74014535|NCT01877187|147579789|OTHER|||||||0.029||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.029
73888025|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|30.4||||0.498|TWO_SIDED|95.0|-58.0|118.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||118.8|-58.0|0.4980
74014536|NCT01877187|147579789|OTHER|||||||0.94||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.94
74014537|NCT01877187|147579791|OTHER|||||||0.06||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.06
74014538|NCT01877187|147579791|OTHER|||||||0.013||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.013
74014539|NCT01877187|147579791|OTHER|||||||0.67||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.67
74014540|NCT03776175|147579794|SUPERIORITY||Difference in LS mean|-44.52||||0|TWO_SIDED|90.0|-54.97|-31.65|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in least square (LS) mean between groups||-31.65|-54.97|0.0000
74014541|NCT03776175|147579794|SUPERIORITY||Difference in LS Mean|-35.4||||0.0007|TWO_SIDED|90.0|-47.4|-20.68|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference LS mean between groups.||-20.68|-47.40|0.0007
74094908|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|||<|0.001|TWO_SIDED|95.0|2.88|4.13|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.13|2.88|<0.001
74014542|NCT03776175|147579794|SUPERIORITY||Difference in LS Mean|-44.64||||0|TWO_SIDED|90.0|-54.8|-32.19|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||-32.19|-54.80|0.0000
74014543|NCT03776175|147579794|SUPERIORITY||Difference in LS Mean|-0.21||||0.9836|TWO_SIDED|90.0|-15.66|18.08|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||18.08|-15.66|0.9836
73880139|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0149|TWO_SIDED|95.0|1.26|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.67|1.26|0.0149
73880140|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|5.64||||0.0009|TWO_SIDED|95.0|2.03|15.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.65|2.03|0.0009
74014544|NCT03776175|147579794|SUPERIORITY||Difference in LS Mean|-14.3||||0.1233|TWO_SIDED|90.0|-27.32|1.06|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||1.06|-27.32|0.1233
74014545|NCT03776175|147579794|SUPERIORITY||Difference in LS Mean|-0.21|||||TWO_SIDED|50.0|-6.82|6.87|||||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.||6.87|-6.82|
74014546|NCT03776175|147579794|SUPERIORITY||Difference in LS Mean|-14.3|||||TWO_SIDED|50.0|-19.86|-8.35|||||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.||-8.35|-19.86|
74014547|NCT02599961|147579801|SUPERIORITY||LS Mean|-82.73|STANDARD_ERROR_OF_MEAN|11.363|<|0.0001|TWO_SIDED|95.0|-105.0|-60.46||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|generalized estimating equation (GEE)|||Month 0-3||-60.46|-105.00|< 0.0001
74014548|NCT02599961|147579801|SUPERIORITY||LS mean|-54.91|STANDARD_ERROR_OF_MEAN|16.097||0.0006|TWO_SIDED|95.0|-86.46|-23.36||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 4-6||-23.36|-86.46|0.0006
74043974|NCT00293241|147638817|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Analysis:Wilcoxon Test for Comparison of Percentage of Ventricular Pacing (%VP) During Followup by Randomization Arm~H0:distribution %VP MVP=distribution %VP DDD~Ha:distribution %VP MVP≠distribution %VP DDD~Ha:"||||<0.0001
74014549|NCT02599961|147579801|SUPERIORITY||LS Mean|-52.53|STANDARD_ERROR_OF_MEAN|16.882||0.0019|TWO_SIDED|95.0|-85.62|-19.45||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 7-9||-19.45|-85.62|0.0019
74014550|NCT02599961|147579801|SUPERIORITY||LS Mean|-82.65|STANDARD_ERROR_OF_MEAN|15.55|<|0.0001|TWO_SIDED|95.0|-113.13|-52.17||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 10-12||-52.17|-113.13|< 0.0001
74014551|NCT00143312|147579807|SUPERIORITY_OR_OTHER||Crude IFI Rate (percent) at 12 months|7.0||||||95.0|2.0|19.0||||||||19|2|
74014552|NCT00143312|147579807|SUPERIORITY_OR_OTHER||IFI Rate (percent) at 12 months|10.0||||||95.0|2.0|27.0||||||||27|2|
74014553|NCT00143312|147579808|SUPERIORITY_OR_OTHER||IFI Rate (percent) at 6 months|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||24|2|
74014554|NCT00143312|147579809|SUPERIORITY_OR_OTHER||IFI Rate (percent) at End of Prophylaxis|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||24|2|
74014555|NCT00143312|147579813|SUPERIORITY_OR_OTHER||survive free of IFI (percent): 6 months|79.0||||||95.0|64.0|91.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||91|64|
74014556|NCT00143312|147579813|SUPERIORITY_OR_OTHER||survive free of IFI (percent): 12 months|69.0||||||95.0|52.0|83.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||83|52|
74014557|NCT03341962|147579828|SUPERIORITY||Odds Ratio (OR)|1.0188||||0.5836|TWO_SIDED||||||Cochran-Mantel-Haenszel|1-sided exact test adjusted for stratification factors (prior use of any biologics and concurrent use of corticosteroids), α=0.097||||||0.5836
74014558|NCT03016325|147579894|SUPERIORITY|Part I, clinically relevant hypotension - relative risk|Relative risk from placebo|2.45|||||TWO_SIDED|95.0|0.83|14.53||||||||14.53|0.83|
74014559|NCT03016325|147579894|SUPERIORITY|Part I, clinically relevant hypotension - relative difference|Relative difference from placebo|0.12|||||TWO_SIDED|95.0|-0.02|0.28||||||||0.28|-0.02|
74043975|NCT00293241|147638818|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Regression, Linear|||||||0.048
74014560|NCT03016325|147579894|SUPERIORITY|Part I, symptoms of hypotension - relative risk|Relative risk from placebo|2.94|||||TWO_SIDED|95.0|0.31|75.47||||||||75.47|0.31|
74014561|NCT03016325|147579894|SUPERIORITY|Part I, symptoms of hypotension - relative difference|Relative difference from placebo|0.04|||||TWO_SIDED|95.0|-0.06|0.15||||||||0.15|-0.06|
74014562|NCT03016325|147579894|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|3.27|||||TWO_SIDED|95.0|1.01|14.66||||||||14.66|1.01|
74014563|NCT03016325|147579894|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.14|||||TWO_SIDED|95.0|0.0|0.29||||||||0.29|0.00|
74014564|NCT03016325|147579894|SUPERIORITY|Part II (low dose), clinically relevant hypotension - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
74014565|NCT03016325|147579894|SUPERIORITY|Part II (low dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
74043976|NCT00293241|147638820|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|95.0|||||Repeated measures logistic regression|||Analysis:Repeated measures logistic regression||||0.78
74043977|NCT00293241|147638821|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Beta-blockers=Change in Beta-blockers Ha:Change in Beta-blockers≠Change in Beta-blockers||||0.34
74014566|NCT03016325|147579894|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative risk|Relative risk from placebo|2.0|||||TWO_SIDED|95.0|0.18|54.35||||||||54.35|0.18|
74014567|NCT03016325|147579894|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.01|||||TWO_SIDED|95.0|-0.05|0.09||||||||0.09|-0.05|
74014568|NCT03016325|147579894|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
74014569|NCT03016325|147579894|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
74014570|NCT03016325|147579894|SUPERIORITY|Part II (high dose), clinically relevant hypotension - relative risk|Relative risk from placebo|1.9|||||TWO_SIDED|95.0|1.04|3.59||||||||3.59|1.04|
74014571|NCT03016325|147579894|SUPERIORITY|Part II (high dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.16|||||TWO_SIDED|95.0|0.01|0.31||||||||0.31|0.01|
74014572|NCT03016325|147579894|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative risk|Relative risk from placebo|5.92|||||TWO_SIDED|95.0|0.91|149.72||||||||149.72|0.91|
74014573|NCT03016325|147579894|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.07|||||TWO_SIDED|95.0|-0.01|0.16||||||||0.16|-0.01|
74014574|NCT03016325|147579894|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.59|||||TWO_SIDED|95.0|0.87|3.21||||||||3.21|0.87|
74014575|NCT03016325|147579894|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.11|||||TWO_SIDED|95.0|-0.04|0.25||||||||0.25|-0.04|
74014576|NCT03016325|147579894|SUPERIORITY|Part II-Japan (low dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
74014577|NCT03016325|147579894|SUPERIORITY|Part II-Japan (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
74014578|NCT03016325|147579894|SUPERIORITY|Part II-Japan (high dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
74014579|NCT03016325|147579894|SUPERIORITY|Part II-Japan (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
74014580|NCT03016325|147579897|SUPERIORITY|Part I, symptoms of hypotension - relative risk|Relative risk from placebo|2.94|||||TWO_SIDED|95.0|0.31|75.47||||||||75.47|0.31|
74014581|NCT03016325|147579897|SUPERIORITY|Part I, symptoms of hypotension - relative difference|Relative difference from placebo|0.04|||||TWO_SIDED|95.0|-0.06|0.15||||||||0.15|-0.06|
74014582|NCT03016325|147579897|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative risk|Relative risk from placebo|2.0|||||TWO_SIDED|95.0|0.18|54.35||||||||54.35|0.18|
74014583|NCT03016325|147579897|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.01|||||TWO_SIDED|95.0|-0.05|0.09||||||||0.09|-0.05|
74014584|NCT03016325|147579897|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative risk|Relative risk from placebo|5.92|||||TWO_SIDED|95.0|0.91|149.72||||||||149.72|0.91|
74014585|NCT03016325|147579897|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.07|||||TWO_SIDED|95.0|-0.01|0.16||||||||0.16|-0.01|
74014586|NCT03016325|147579898|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|3.27|||||TWO_SIDED|95.0|1.01|14.66||||||||14.66|1.01|
74014587|NCT03016325|147579898|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.14|||||TWO_SIDED|95.0|0.0|0.29||||||||0.29|0.00|
74014588|NCT03016325|147579898|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
74014589|NCT03016325|147579898|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
74014590|NCT03016325|147579898|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.59|||||TWO_SIDED|95.0|0.87|3.21||||||||3.21|0.87|
74014591|NCT03016325|147579898|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.11|||||TWO_SIDED|95.0|-0.04|0.25||||||||0.25|-0.04|
74014592|NCT03016325|147579898|SUPERIORITY|Part II-Japan (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
74014593|NCT03016325|147579898|SUPERIORITY|Part II-Japan (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
74043978|NCT00293241|147638821|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Digitalis/digoxin=Change in Digitalis/digoxin Ha:Change in Digitalis/digoxin≠Change in Digitalis/digoxin||||0.65
74094909|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.007|TWO_SIDED|95.0|0.17|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.17|0.007
74014594|NCT02970292|147579926|SUPERIORITY||Difference in MMRM LSMs|-2.1|STANDARD_ERROR_OF_MEAN|1.24||0.094|TWO_SIDED|95.0|-4.5|0.4|||mixed-effects model for repeated measure|||||0.4|-4.5|0.0940
74014595|NCT00814775|147579951|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.72|TWO_SIDED|95.0|0.55|2.37|||Regression, Cox||CTrach vs. Fastrach|||2.37|0.55|0.72
74014596|NCT00814775|147579952|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76||||0.45|TWO_SIDED|95.0|0.38|1.54|||Regression, Cox||CTrach vs. Fastrach|||1.54|0.38|0.45
74014597|NCT00513500|147579954|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.32||||||95.0|2.19|8.94||||||||8.94|2.19|
74014598|NCT00513500|147579955|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.23||||||95.0|0.14|0.38||||||||0.38|0.14|
74043979|NCT00293241|147638821|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Calcium antagonists=Change in Calcium antagonists Ha:Change in Calcium antagonists≠Change in Calcium antagonists||||0.55
74043980|NCT00293241|147638821|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Antiarrhythmic drug=Change in Antiarrhythmic drug Ha:Change in Antiarrhythmic drug≠Change in Antiarrhythmic drug||||0.53
74043981|NCT00293241|147638823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.243||||0.33|TWO_SIDED|95.0|0.803|1.923|||Log Rank|||"Analysis:Time to all-cause death~H0:survival MVP ON=survival MVP OFF Ha:survival MVP ON≠survival MVP OFF"||1.923|0.803|0.33
74014599|NCT00513500|147579956|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.44||||||95.0|0.21|0.93||||||||0.93|0.21|
74014600|NCT00749996|147579961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.228|TWO_SIDED|95.0|-1.59|0.38|||t-test, 2 sided|||The null-hypothesis: Ho: Δ VAS DIAM = Δ VAS Control will be tested against the alternative hypothesis:HA: Δ VAS DIAM ≠ Δ VAS Control.Where Δ is the average decrease in VAS score (baseline - 6 months). A minimal sample size of 240 analyzable patients is required to demonstrate with 80% power a difference in back pain reduction that is significant at the 95% level, comparing DIAM and Control groups. 268 patients will be enroll to allow of up to 10% attrition.||0.38|-1.59|0.228
74014601|NCT00749996|147579962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.719|TWO_SIDED|95.0|-8.8|6.08|||t-test, 2 sided|||The null-hypothesis(Ho: Δ ODI DIAM = Δ ODI Control) will be tested against the alternative hypothesis (HA: Δ ODI DIAM ≠ Δ ODI Control). Δ ODI DIAM = average change in the ODI (12 months - baseline) in the DIAM treated patient group and Δ VAS Control =average change in the ODI in the Control group.||6.08|-8.80|0.719
74014602|NCT01902290|147579963|SUPERIORITY||Difference|-0.05||||0.5219|TWO_SIDED|95.0|-0.203|0.103|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline ACQ score.|Difference = Brodalumab - Placebo|||0.103|-0.203|0.5219
74014603|NCT01902290|147579964|SUPERIORITY||Rate Ratio|1.41||||0.102|TWO_SIDED|95.0|0.93|2.12|||Generalized linear model|Generalized linear model under a negative binomial distribution assumption adjusting for stratification factors.|Rate ratio = Brodalumab : Placebo|||2.12|0.93|0.102
74014604|NCT01902290|147579965|SUPERIORITY||Difference|-0.038||||0.6632|TWO_SIDED|95.0|-0.21|0.134|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification factors, and baseline ACQ score.|Difference = Brodalumab - Placebo|||0.134|-0.210|0.6632
74014605|NCT01902290|147579966|SUPERIORITY||Rate Ratio|1.45||||0.096|TWO_SIDED|95.0|0.94|2.24|||Generalized linear model|Generalized linear model under a negative binomial distribution assumption adjusting for stratification factors.|Rate ratio = Brodalumab : Placebo|||2.24|0.94|0.096
74014606|NCT01902290|147579967|SUPERIORITY||Difference|-0.046||||0.329|TWO_SIDED|95.0|-0.137|0.046|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline score.|Difference = Brodalumab - Placebo|||0.046|-0.137|0.3290
74014607|NCT01902290|147579968|SUPERIORITY||Difference|0.03||||0.4549||95.0|-0.049|0.109|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and FEV1.|Difference = Brodalumab - Placebo|||0.109|-0.049|0.4549
74014608|NCT01902290|147579969|SUPERIORITY||Difference|0.128||||0.6317||95.0|-0.396|0.653|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline value.|Difference = Brodalumab - Placebo|||0.653|-0.396|0.6317
74014609|NCT01902290|147579970|SUPERIORITY||Hazard Ratio (HR)|1.277||||0.238|TWO_SIDED|95.0|0.843|1.936|||Log Rank|Log rank test stratified for baseline stratification factors.||||1.936|0.843|0.238
74014610|NCT01902290|147579971|SUPERIORITY||Odds Ratio (OR)|1.25||||0.351||95.0|0.78|2.01|||Regression, Logistic|Logistic regression adjusted for stratification factors.||||2.01|0.78|0.351
74014611|NCT01902290|147579972|SUPERIORITY||Difference|-0.001||||0.987||95.0|-0.174|0.171|||Mixed-effects model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline AQLQ score.|Difference = Brodalumab - Placebo|||0.171|-0.174|0.9870
74014612|NCT01902290|147579973|SUPERIORITY||Difference|0.635||||0.9053|TWO_SIDED|95.0|-9.82|11.089|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and AM PEFR.|Difference = Brodalumab - Placebo|Analysis of morning peak flow||11.089|-9.820|0.9053
74043982|NCT00293241|147638824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.492||||0.24|TWO_SIDED|95.0|0.148|1.637|||Log Rank|||||1.637|0.148|0.24
74043983|NCT00293241|147638825|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Statistical test for Number of subjects with CV hospitalization||||0.83
74014613|NCT01902290|147579973|SUPERIORITY||Difference|5.92||||0.2661|TWO_SIDED|95.0|-4.515|16.354|||Mixed-effects model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and PM PEFR.|Difference = Brodalumab - Placebo|Analysis of evening peak flow||16.354|-4.515|0.2661
74014614|NCT01902290|147579974|SUPERIORITY||Difference|-4.021||||0.0871|TWO_SIDED|95.0|-8.627|0.586|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, race group, height and PEFR variation.|Difference = Brodalumab - Placebo|||0.586|-8.627|0.0871
74014615|NCT00606086|147579986|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Mantel-Haenszel test|||||||1.000
74014616|NCT02500628|147579987|OTHER|||||||0.77|||||||t-test, 2 sided|||comparison between fibromyalgia and non-fibromyalgia group||||0.77
74014617|NCT02500628|147579988|OTHER|||||||0.27|||||||t-test, 2 sided|||||||0.27
74014618|NCT02500628|147579989|OTHER|||||||0.92|||||||t-test, 2 sided|||difference between fibromyalgia and non-fibromyalgia patients.||||0.92
74014619|NCT00391222|147579990|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED|95.0||||As defined in the protocol, the olanzapine arm was not included in the primary outcome comparison. Data on the olanzapine arm are presented in outcome measure 7.|Log Rank|||Comparison between risperidone LAI and placebo was performed using a log-rank test controlling for patient type at screening (acute or non-acute) and for geographic region. As recurrence rates at 9 months were assumed to be 45% for risperidone LAI and 68% for placebo, the study would have approximately 90% power to detect a clinically meaningful difference of 23% in recurrence rates of a mood episode if in Period III 100 patients were randomized to each of the 2 relevant treatment arms.||||0.057
74014620|NCT00391222|147579991|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.005
74014621|NCT00391222|147579991|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||<0.0001
74014622|NCT00391222|147579992|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.655
74014623|NCT00391222|147579992|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.011
74014624|NCT00391222|147579993|SUPERIORITY_OR_OTHER|||||||0.2882|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.2882
74014625|NCT00391222|147579993|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||<0.0001
74014626|NCT00391222|147579994|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||<0.001
74014627|NCT00391222|147579994|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||<0.001
74014628|NCT00391222|147579995|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||0.480
74043984|NCT00293241|147638828|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-R interval=Change in P-R interval Ha:Change in P-R interval≠Change in P-R interval||||0.34
74043985|NCT00293241|147638828|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in QRS duration=Change in QRS duration Ha:Change in QRS duration≠Change in QRS duration||||0.19
74043986|NCT00293241|147638828|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-wave duration=Change in P-wave duration Ha:Change in P-wave duration≠Change in P-wave duration||||0.29
74043987|NCT00293241|147638829|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|95.0|||||Fisher Exact|||No Symptoms (Baseline)||||0.24
74043988|NCT00293241|147638829|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Fisher Exact|||No Symptoms (12 months)||||0.92
74043989|NCT00293241|147638829|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||No Symptoms (24 Months)||||1.0
74043990|NCT00293241|147638830|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
74043991|NCT01216397|147638855|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.4||||||90.0|94.2|105.0|||ANOVA|||Standard batch vs. Side batch||105.0|94.2|
74043992|NCT01216397|147638856|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.1||||||90.0|96.1|104.2|||ANOVA|||Standard batch vs. Side batch||104.2|96.1|
74043993|NCT01216397|147638857|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.1||||||90.0|94.7|105.8|||ANOVA|||Standard batch vs. Side batch||105.8|94.7|
74043994|NCT01216397|147638865|SUPERIORITY_OR_OTHER||adjusted gMean ratio|97.9||||||90.0|92.5|103.7|||ANOVA|||Standard batch vs. Side batch||103.7|92.5|
73880141|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.79||||0.6434|TWO_SIDED|95.0|0.29|2.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.15|0.29|0.6434
74014629|NCT00391222|147579995|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||0.001
74014630|NCT04770389|147580008|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
74014631|NCT04770389|147580009|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
74014632|NCT04770389|147580010|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
74014633|NCT04770389|147580011|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
74014634|NCT04770389|147580012|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
74014635|NCT04770389|147580013|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
74014636|NCT04770389|147580014|SUPERIORITY||Least Squares (LS) Means|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
73880142|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4784|TWO_SIDED|95.0|0.54|3.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.69|0.54|0.4784
74014637|NCT04770389|147580015|SUPERIORITY||Least Squares (LS) Mean|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
74094910|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.35|||<|0.001|TWO_SIDED|95.0|0.91|1.8|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.80|0.91|<0.001
74014638|NCT04770389|147580016|SUPERIORITY||Least Squares (LS) Mean|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
74014639|NCT04770389|147580017|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
74014640|NCT04770389|147580018|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
74094911|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.27|3.52|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.52|2.27|<0.001
74094912|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|||<|0.001|TWO_SIDED|95.0|1.52|2.79|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.79|1.52|<0.001
74094913|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74||||0.001|TWO_SIDED|95.0|0.3|1.19|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|0.30|0.001
74014641|NCT04770389|147580019|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
74014642|NCT04770389|147580020|SUPERIORITY||Least Squares (LS) Means|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
74014643|NCT04770389|147580021|SUPERIORITY||Least Squares (LS) Mean|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
74014644|NCT04770389|147580022|SUPERIORITY||Least Squares (LS) Means|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
74014645|NCT04770389|147580023|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
74014646|NCT04770389|147580024|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
74014647|NCT04770389|147580025|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
74014648|NCT04770389|147580026|SUPERIORITY||Least Squares (LS) Means|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
74014649|NCT04770389|147580027|SUPERIORITY||Least Squares (LS) Mean|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
74014650|NCT04770389|147580028|SUPERIORITY||Least Squares (LS) Mean|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
74014651|NCT04770389|147580029|SUPERIORITY||Least Squares (LS) Means|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
74043995|NCT01216397|147638866|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.4||||||90.0|95.7|105.4|||ANOVA|||||105.4|95.7|
74043996|NCT01216397|147638867|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.3||||||90.0|95.7|105.2|||ANOVA|||Standard batch vs. Side batch||105.2|95.7|
74043997|NCT00971633|147638888|NON_INFERIORITY_OR_EQUIVALENCE|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.904|||||TWO_SIDED|95.0|0.796|1.028|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||1.028|0.796|
74043998|NCT00971633|147638888|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.991|||||TWO_SIDED|95.0|0.873|1.126|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally||1.126|0.873|
74043999|NCT00971633|147638889|NON_INFERIORITY_OR_EQUIVALENCE|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K.) ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.886|||||TWO_SIDED|95.0|0.813|0.966|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||0.966|0.813|
74044000|NCT00971633|147638889|NON_INFERIORITY_OR_EQUIVALENCE|§ Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.951|||||TWO_SIDED|95.0|0.872|1.037|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally. Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally||1.037|0.872|
74044001|NCT01455415|147638895|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.3287|TWO_SIDED|95.0|0.83|1.73||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.||1.73|0.83|0.3287
74014652|NCT04770389|147580030|SUPERIORITY||Least Squares (LS) Mean|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
74014653|NCT04770389|147580031|SUPERIORITY||Least Squares (LS) Mean|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
74014654|NCT04770389|147580032|SUPERIORITY||Least Squares (LS) Means|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
74094914|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|3.44|||<|0.001|TWO_SIDED|95.0|2.79|4.09|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.09|2.79|<0.001
74014655|NCT04770389|147580033|SUPERIORITY||Least Squares (LS) Mean|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
74014656|NCT04770389|147580034|SUPERIORITY||Least Squares (LS) Mean|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
74014657|NCT04770389|147580035|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
74014658|NCT04770389|147580036|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
74014659|NCT04770389|147580037|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
74014660|NCT04770389|147580038|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
74014661|NCT04770389|147580039|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
74014662|NCT04770389|147580040|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
74014663|NCT01890642|147580041|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Kruskal-Wallis|||||||0.01
74014664|NCT01890642|147580042|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Kruskal-Wallis|||||||0.80
74014665|NCT01890642|147580043|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Kruskal-Wallis|||||||0.004
74014666|NCT01890642|147580044|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Kruskal-Wallis|||||||0.0001
74014667|NCT01890642|147580045|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Kruskal-Wallis|||||||0.37
74014668|NCT00533442|147580046|SUPERIORITY|||||||0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Kidney (logrank test).||||0.01
74014669|NCT00533442|147580046|SUPERIORITY|||||||0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Pancreas (logrank test).||||0.01
74014670|NCT00533442|147580046|SUPERIORITY|||||||0.16|||||||Log Rank|||Death-Censored Kidney Graft Failure (logrank test).||||0.16
74014671|NCT00533442|147580046|SUPERIORITY|||||||0.12|||||||Log Rank|||Death-Censored Pancreas Graft Failure (logrank test).||||0.12
74014672|NCT00533442|147580046|SUPERIORITY|||||||0.96|||||||Log Rank|||Death-Uncensored (Kidney \& Pancreas) Graft Survival (logrank test).||||0.96
74014673|NCT00533442|147580046|SUPERIORITY||||||>|0.99||||||Patient Death (logrank test).|Log Rank|||||||>0.99
74014674|NCT00533442|147580047|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Comparison of Mean eGFR at 12 Months Post-Transplant (t-test).||||0.21
74014675|NCT00533442|147580047|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Comparison of Mean eGFR at 36 Months Post-Transplant (t-test).||||0.71
74014676|NCT00533442|147580047|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Comparison of Mean eGFR at 60 Months Post-Transplant (t-test).||||0.33
74014677|NCT00533442|147580048|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 12 Months Post-Transplant (t-test).||||.47
74014678|NCT00533442|147580048|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 36 Months Post-Transplant (t-test).||||0.97
74014679|NCT00533442|147580048|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 60 Months Post-Transplant (t-test).||||0.75
74014680|NCT01508702|147580054|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.19|0.37|||Cochran-Mantel-Haenszel|||||0.37|0.19|<0.0001
74014681|NCT01187953|147580065|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999|TWO_SIDED|||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||>0.999
74014682|NCT01187953|147580065|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.821|TWO_SIDED|||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.821
74014683|NCT01187953|147580065|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.9|TWO_SIDED|||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.900
74014684|NCT01187953|147580065|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999|TWO_SIDED|||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||>0.999
74014685|NCT01187953|147580066|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.835|TWO_SIDED|||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.835
74014686|NCT01187953|147580066|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.548|TWO_SIDED|||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.548
74014687|NCT01187953|147580066|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.822|TWO_SIDED|||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.822
74044002|NCT01455415|147638896|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.0625|TWO_SIDED|95.0|0.98|2.51||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.||2.51|0.98|0.0625
74044003|NCT01455415|147638897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9448|TWO_SIDED|95.0|-0.21|0.22||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain severity, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.22|-0.21|0.9448
74044004|NCT01455415|147638898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4548|TWO_SIDED|95.0|-0.32|0.14||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline interference score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.14|-0.32|0.4548
74044005|NCT01455415|147638899|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.0272|TWO_SIDED|95.0|-0.44|-0.03||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using linear mixed effects model including baseline score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||-0.03|-0.44|0.0272
74044006|NCT01455415|147638900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.7344|TWO_SIDED|95.0|-0.42|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-A score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.30|-0.42|0.7344
74044007|NCT01455415|147638901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.6007|TWO_SIDED|95.0|-0.42|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-D score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.24|-0.42|0.6007
74044008|NCT01455415|147638902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|1.04||0.2987|TWO_SIDED|95.0|-3.13|0.96||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline total score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.96|-3.13|0.2987
74044009|NCT01455415|147638903|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.26||0.1769|TWO_SIDED|95.0|-0.85|0.16||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline symptoms domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.16|-0.85|0.1769
74044010|NCT01455415|147638904|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.5119|TWO_SIDED|95.0|-0.48|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline activities of daily living domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.24|-0.48|0.5119
74044011|NCT01455415|147638905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.62||0.4335|TWO_SIDED|95.0|-1.72|0.74||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline physical functioning / large fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.74|-1.72|0.4335
74044012|NCT01455415|147638906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.16||0.9653|TWO_SIDED|95.0|-0.31|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline small fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.30|-0.31|0.9653
74014688|NCT01187953|147580066|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.383|TWO_SIDED|||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.383
74014689|NCT02572752|147580067|SUPERIORITY_OR_OTHER||gMean Ratio|97.478|STANDARD_ERROR_OF_MEAN|11.57|<|0.0001|TWO_SIDED|90.0|94.545|100.502|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed||100.502|94.545|<0.0001
74014690|NCT02572752|147580068|SUPERIORITY_OR_OTHER||gMean Ratio|97.004|STANDARD_ERROR_OF_MEAN|20.77|<|0.0001|TWO_SIDED|90.0|90.948|103.463|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed.||103.463|90.948|<0.0001
74014691|NCT02572752|147580069|SUPERIORITY_OR_OTHER||gMean Ratio|97.149|STANDARD_DEVIATION|11.4|<|0.0001|TWO_SIDED|90.0|94.223|100.166|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed||100.166|94.223|<0.0001
74014692|NCT01464307|147580070|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.0||||0.777|TWO_SIDED|95.0|-0.1|0.2|||Mixed-Model Repeated Measures|||The number of subjects included in the MMRM analysis was only 286 because a covariate was missing for 3 subjects.||0.2|-0.1|0.777
74014693|NCT01464307|147580071|SUPERIORITY_OR_OTHER|||||||0.804||||||worst-case analysis.|Wilcoxon's Rank-Sum Test|||The statistical analysis provided was for all categories of this outcome measure.||||0.804
74014694|NCT01464307|147580072|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.845|TWO_SIDED|95.0|0.63|1.74||observed cases analysis.|Regression, Logistic|||Week 4. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=283 for week 4.||1.74|0.63|0.845
74014695|NCT01464307|147580072|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.437|TWO_SIDED|95.0|0.73|2.04||observed cases analysis.|Regression, Logistic|||Week 8. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=279 for week 8.||2.04|0.73|0.437
74014696|NCT01464307|147580072|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.698|TWO_SIDED|95.0|0.59|2.21||observed cases analysis.|Regression, Logistic|||Week 12. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=273 for week 12.||2.21|0.59|0.698
74014697|NCT01780831|147580151|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had grade 3/4 AE through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|25.0|||||TWO_SIDED|90.0|9.0|48.4||||||||48.4|9|
73880143|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0955|TWO_SIDED|95.0|0.87|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.55|0.87|0.0955
74014698|NCT01780831|147580151|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had grade 3/4 AE through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|31.0|||||TWO_SIDED|90.0|18.7|46.6||||||||46.6|18.7|
73888026|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|54.5||||0.2253|TWO_SIDED|95.0|-33.9|142.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||142.9|-33.9|0.2253
74014699|NCT01780831|147580158|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had grade 3/4 AE through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|25.0|||||TWO_SIDED|90.0|9.0|48.4||||||||48.4|9|
74014700|NCT01780831|147580158|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had grade 3/4 AE through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|43.0|||||TWO_SIDED|90.0|28.6|58.1||||||||58.1|28.6|
73880144|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.06||||0.9082|TWO_SIDED|95.0|0.4|2.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.79|0.40|0.9082
73880145|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6478|TWO_SIDED|95.0|0.48|3.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.21|0.48|0.6478
73880146|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0104|TWO_SIDED|95.0|1.35|9.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.82|1.35|0.0104
73880147|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|6.66||||0.0004|TWO_SIDED|95.0|2.34|18.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.94|2.34|0.0004
73880148|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.91||||0.856|TWO_SIDED|95.0|0.34|2.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.45|0.34|0.8560
73880149|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.6||||0.3319|TWO_SIDED|95.0|0.62|4.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.17|0.62|0.3319
74014701|NCT01780831|147580159|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had SADR of Grade 3 or 4 through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI|6.0|||||TWO_SIDED|90.0|0.3|26.4||||||||26.4|0.3|
74014702|NCT01780831|147580159|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had SADR of Grade 3 or 4 through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|0.0|||||TWO_SIDED||||||||CI is not provided since the estimation parameter is 0.|||||
74014703|NCT01780831|147580160|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had SADR of Grade 3 or 4 through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|6.0|||||TWO_SIDED|90.0|0.3|26.4||||||||26.4|0.3|
74014704|NCT01780831|147580160|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had SADR of Grade 3 or 4 through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|0.0|||||TWO_SIDED||||||||CI is not provided since the estimation parameter is 0.|||||
74014705|NCT01780831|147580161|OTHER|||||||0.298|||||||Wilcoxon (Mann-Whitney)|||||||0.298
74014706|NCT01780831|147580162|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
74014707|NCT01780831|147580163|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
73880150|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0747|TWO_SIDED|95.0|0.92|5.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.95|0.92|0.0747
74014708|NCT04749459|147580169|OTHER|A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).|||||||||||||||||CSM Classic: CIs +/- 13.7% P2 Control Standard (vs. CSM Classic) CIs +/- 16.4%|||
74014709|NCT04749459|147580169|OTHER|A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).|||||||||||||||||CSM Strawberry Flavor: CIs +/- 16.6% P2 Control Standard (vs CSM Strawberry Flavour): CIs +/- 16.0%|||
74014710|NCT02429414|147580172|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74014711|NCT02429414|147580173|SUPERIORITY|||||||0.0209|||||||t-test, 2 sided|||||||0.0209
74014712|NCT02429414|147580174|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||||||0.078
74014713|NCT00983983|147580191|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|||Change over time in the ALSFRS-R was analyzed using random-slopes models||||0.07
74014714|NCT00983983|147580193|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Fisher Exact|||||||0.06
74014715|NCT00983983|147580194|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Fisher Exact|||||||0.0005
74014716|NCT00983983|147580195|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
74014717|NCT00382993|147580241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.63|||<|0.001||95.0|2.76|11.49|||ANOVA|||||11.49|2.76|<0.001
74014718|NCT03015259|147580264|EQUIVALENCE|To show the clinical equivalence, an analysis of covariance model was fit on the participants from the test budesonide/formoterol fumarate and Symbicort groups, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate.|Test/Referece LS Mean Ratio|1.04|||||TWO_SIDED|90.0|0.958|1.13|||||Fieller's formula was applied|Only Treatments 1 and 2 were compared for equivalence. Treatment 3 (placebo) was subtracted from both Treatments 1 and 2, as this primary endpoint was baseline adjusted.||1.130|0.958|
74014719|NCT03015259|147580265|EQUIVALENCE|To show the clinical equivalence, an ANCOVA model was fit with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate.|Test/Reference LS Mean Ratio|1.004|||||TWO_SIDED|90.0|0.889|1.14|||||Fieller's formula was applied|Treatments 1 and 2 were baseline adjusted by subtracting Treatment 3 (placebo) from each.||1.140|0.889|
74014720|NCT03015259|147580266|OTHER|||||||||||||||||Comparison of means, no formal statistical comparison|no statistical significance applied|||
74094915|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.003|TWO_SIDED|95.0|0.24|1.15|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.15|0.24|0.003
74094916|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.85|||<|0.001|TWO_SIDED|95.0|1.39|2.31|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.31|1.39|<0.001
74014721|NCT01827670|147580304|SUPERIORITY_OR_OTHER||Adjusted Mean|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.53|-1.06|||ANCOVA|From ANCOVA model: Treatment as fixed factor \& baseline Schiff score as covariate.|Difference was 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-1.06|-1.53|<0.0001
74014722|NCT01827670|147580305|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.62|||ANCOVA|From ANCOVA model: Treatment as fixed factor \& baseline Schiff score as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-0.62|-1.00|<0.0001
74014723|NCT01827670|147580306|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|27.2|||<|0.0001|TWO_SIDED|95.0|19.4|35.1|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||35.1|19.4|<0.0001
74014724|NCT01827670|147580307|SUPERIORITY_OR_OTHER||Adjusted Mean|7.5||||0.0138|TWO_SIDED|95.0|1.6|13.4|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||13.4|1.6|0.0138
74014725|NCT01827670|147580308|SUPERIORITY_OR_OTHER||Adjusted Mean|-12.14||||0.0003|TWO_SIDED|95.0|-18.51|-5.77|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-5.77|-18.51|0.0003
74014726|NCT01827670|147580309|SUPERIORITY_OR_OTHER||Adjusted Mean|-21.82|||<|0.0001|TWO_SIDED|95.0|-29.55|-14.09|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments."||-14.09|-29.55|<0.0001
74044013|NCT01455415|147638907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.12||0.269|TWO_SIDED|95.0|-0.38|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline autonomic domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.11|-0.38|0.2690
74044014|NCT01455415|147638908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.9951|TWO_SIDED|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline mobility domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.05|-0.05|0.9951
74094917|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.74|||<|0.001|TWO_SIDED|95.0|2.1|3.39|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.39|2.10|<0.001
74094918|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|||<|0.001|TWO_SIDED|95.0|0.94|2.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.24|0.94|< 0.001
74094919|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15|||<|0.001|TWO_SIDED|95.0|0.69|1.61|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|0.69|<0.001
74094920|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|3.33|||<|0.001|TWO_SIDED|95.0|2.67|4.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.00|2.67|<0.001
74094921|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74||||0.002|TWO_SIDED|95.0|0.27|1.2|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.27|0.002
74014727|NCT00790907|147580314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.267|TWO_SIDED|95.0|0.54|1.19|||Regression, Logistic|||||1.19|0.54|0.267
74014728|NCT01618214|147580353|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%.|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.08||||95.0|-0.19|0.14|||Regression, Linear|||FAS||0.14|-0.19|
74014729|NCT00708123|147580400|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.97||||0.0265|TWO_SIDED|95.0|0.47|7.48||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||7.48|0.47|0.0265
74014730|NCT00708123|147580400|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.66||||0.0017|TWO_SIDED|95.0|2.15|9.18||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors as treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||9.18|2.15|0.0017
74094922|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.94|||<|0.001|TWO_SIDED|95.0|1.47|2.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.41|1.47|<0.001
74094923|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|||<|0.001|TWO_SIDED|95.0|1.93|3.26|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.26|1.93|<0.001
74094924|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|||<|0.001|TWO_SIDED|95.0|0.73|2.07|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.07|0.73|<0.001
74014731|NCT00708123|147580401|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|-1.69||||0.3413|TWO_SIDED|95.0|-5.19|1.8||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1.80|-5.19|0.3413
74014732|NCT00708123|147580401|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.26|||<|0.0001|TWO_SIDED|95.0|6.76|13.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||13.76|6.76|<0.0001
74094925|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|||<|0.001|TWO_SIDED|95.0|0.73|1.67|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.67|0.73|<0.001
74094926|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|3.19|||<|0.001|TWO_SIDED|95.0|2.51|3.87|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.87|2.51|<0.001
74094927|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76||||0.002|TWO_SIDED|95.0|0.29|1.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.23|0.29|0.002
74094928|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.85|||<|0.001|TWO_SIDED|95.0|1.37|2.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.33|1.37|< 0.001
74094929|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.43|||<|0.001|TWO_SIDED|95.0|1.75|3.11|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.11|1.75|<0.001
74094930|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|||<|0.001|TWO_SIDED|95.0|0.66|2.03|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.03|0.66|<0.001
74094931|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.61|1.56|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.56|0.61|<0.001
74094932|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.65|||<|0.001|TWO_SIDED|95.0|1.95|3.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.35|1.95|<0.001
73880151|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8986|TWO_SIDED|95.0|0.41|2.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.76|0.41|0.8986
73880152|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9712|TWO_SIDED|95.0|0.38|2.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.53|0.38|0.9712
73880153|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|3.31||||0.091|TWO_SIDED|95.0|1.22|8.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.98|1.22|0.0910
73880154|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|5.68||||0.0011|TWO_SIDED|95.0|2.01|16.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||16.06|2.01|0.0011
73880155|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8466|TWO_SIDED|95.0|0.35|2.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.39|0.35|0.8466
73880156|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1409|TWO_SIDED|95.0|0.79|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.21|0.79|0.1409
73880157|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1212|TWO_SIDED|95.0|0.82|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.25|0.82|0.1212
74014733|NCT00708123|147580401|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.19|||<|0.0001|TWO_SIDED|95.0|9.69|16.68||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||16.68|9.69|<0.0001
73880158|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.48||||0.4269|TWO_SIDED|95.0|0.56|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.88|0.56|0.4269
74014734|NCT00708123|147580401|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.57|||<|0.0001|TWO_SIDED|95.0|5.09|12.05||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||12.05|5.09|<0.0001
74094933|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.015|TWO_SIDED|95.0|0.12|1.09|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.12|0.015
73880159|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5454|TWO_SIDED|95.0|0.52|3.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.49|0.52|0.5454
73880160|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0595|TWO_SIDED|95.0|0.96|7.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.15|0.96|0.0595
73880161|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0041|TWO_SIDED|95.0|1.62|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.98|1.62|0.0041
73880162|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.77||||0.6121|TWO_SIDED|95.0|0.28|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.13|0.28|0.6121
73880163|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.8||||0.2329|TWO_SIDED|95.0|0.68|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.75|0.68|0.2329
74094934|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|||<|0.001|TWO_SIDED|95.0|1.24|2.22|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.22|1.24|<0.001
74094935|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.05|||<|0.001|TWO_SIDED|95.0|1.35|2.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.74|1.35|<0.001
74094936|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92||||0.01|TWO_SIDED|95.0|0.22|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.62|0.22|0.010
74014735|NCT00708123|147580401|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.5|||<|0.0001|TWO_SIDED|95.0|8.01|14.98||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||14.98|8.01|<0.0001
74014736|NCT00708123|147580401|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.59||||0.0104|TWO_SIDED|95.0|-8.1|-1.09||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||-1.09|-8.10|0.0104
74014737|NCT00708123|147580401|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.52|||<|0.0001|TWO_SIDED|95.0|4.04|11.01||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||11.01|4.04|<0.0001
74014738|NCT00708123|147580401|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|2.93||||0.0986|TWO_SIDED|95.0|-0.55|6.41||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||6.41|-0.55|0.0986
74014739|NCT00708123|147580402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|196.74||||0.0148|TWO_SIDED|95.0|38.89|354.6||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided at 5% significance level.||354.60|38.89|0.0148
74014740|NCT00708123|147580402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|246.7||||0.0024|TWO_SIDED|95.0|88.3|405.1||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||405.10|88.30|0.0024
74014741|NCT00708123|147580402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.96||||0.5328|TWO_SIDED|95.0|-207.62|107.71||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||107.71|-207.62|0.5328
74014742|NCT00708123|147580402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-406.19|||<|0.0001|TWO_SIDED|95.0|-564.0|-248.37||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||-248.37|-564.00|<0.0001
74014743|NCT00708123|147580402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|602.93|||<|0.0001|TWO_SIDED|95.0|445.97|759.9||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||759.90|445.97|<0.0001
74044015|NCT01455415|147638909|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9726|TWO_SIDED|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline self-care domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.05|-0.05|0.9726
74044016|NCT01455415|147638910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.5497|TWO_SIDED|95.0|-0.04|0.08||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline usual activities domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.08|-0.04|0.5497
74094937|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12|||<|0.001|TWO_SIDED|95.0|0.63|1.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|0.63|<0.001
74094938|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|||<|0.001|TWO_SIDED|95.0|1.47|2.88|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.88|1.47|<0.001
74094939|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.022|TWO_SIDED|95.0|0.08|1.06|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.06|0.08|0.022
73880164|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0891|TWO_SIDED|95.0|0.88|5.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.90|0.88|0.0891
74044017|NCT01455415|147638911|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1495|TWO_SIDED|95.0|-0.02|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain / discomfort domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.11|-0.02|0.1495
74044018|NCT01455415|147638912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1297|TWO_SIDED|95.0|-0.11|0.01||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline anxiety / depression domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.01|-0.11|0.1297
74044019|NCT01455415|147638913|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.4279|TWO_SIDED|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 1997 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.02|-0.04|0.4279
74044020|NCT01455415|147638914|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.5505|TWO_SIDED|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 2001 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.02|-0.04|0.5505
74044021|NCT01455415|147638915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0604|TWO_SIDED|||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a Cochran-Mantel-Haenszel (CMH) test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.||||0.0604
74044022|NCT01455415|147638916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.106||0.7174|TWO_SIDED|95.0|-0.248|0.171||Primary analysis was two-sided and performed at the 0.05 significance level.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||A longitudinal analysis was done using a repeated measure linear mixed effects model including visit, treatment, an indicator variable for Week 6, and treatment by visit and by the indicator variable interaction as fixed effect factors and participant within sequence and within-participant error (estimated by using an unstructured covariance structure) as random factors. The treatment differences were tested using within-participant variability as the error term.||0.171|-0.248|0.7174
74044023|NCT01455415|147638917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1511|TWO_SIDED|||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a CMH test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.||||0.1511
74044024|NCT01496274|147638937|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P value is based on a Wilcoxon signed-rank test of H0: AsBR ratio (prophylaxis regimen/on-demand regimen) ≥ 0.50. The ratio was based on the original scale.|Wilcoxon signed-rank test|||A test of null hypothesis that the ratio of AsBR (prophylaxis regimen/on-demand regimen) was ≥ 0.50 was conducted at the 1-sided 0.025 level. Matched pairs design with 19 subjects and 2 observations per subject.||||<0.0001
74044025|NCT00701441|147639006|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||For comparing pre versus post, paired t tests were used. We considered tests in the hypothesized direction conclusive|t-test, 2 sided|For each comparison, we tested at the 0.05 level with double-sided P values. We used no correction for multiple testing when declaring significance.||Flow mediated dilation = \[(average maximum dilation post cuff deflation - average baseline diameter)/ average baseline diameter\]100||||0.02
74094940|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|0.95|1.95|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.95|0.95|<0.001
74094941|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|0.9|2.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.30|0.90|<0.001
73888027|NCT01746901|147309530|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7||||0.7945|TWO_SIDED|95.0|-76.8|100.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||100.1|-76.8|0.7945
74094942|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72||||0.045|TWO_SIDED|95.0|0.02|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.02|0.045
74044026|NCT00701441|147639007|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||We only consider tests in the hypothesized direction conclusive, so testing is conservative from that perspective. However, we used no correction for multiple testing when declaring significance|t-test, 2 sided|||For comparing pre- versus post-treatment, paired t tests were used. For each variable and comparison, we tested at the 0.05 level with double-sided P values.||||0.02
74044027|NCT01015820|147639008|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05||||0.001
74014744|NCT00708123|147580402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|652.89|||<|0.0001|TWO_SIDED|95.0|495.05|810.72||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||810.72|495.05|<0.0001
74014745|NCT00708123|147580402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|847.55|||<|0.0001|TWO_SIDED|95.0|690.54|1004.55||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1004.55|690.54|<0.0001
74044028|NCT01015820|147639009|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05||||0.03
74094943|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.88|||<|0.001|TWO_SIDED|95.0|0.38|1.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.38|<0.001
74094944|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.78|||<|0.001|TWO_SIDED|95.0|1.09|2.47|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.47|1.09|<0.001
74094945|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.024|TWO_SIDED|95.0|0.07|1.04|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.04|0.07|0.024
74094946|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.16|||<|0.001|TWO_SIDED|95.0|0.67|1.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.65|0.67|<0.001
74094947|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.23|||<|0.001|TWO_SIDED|95.0|0.54|1.92|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.92|0.54|<0.001
73888028|NCT01746901|147309531|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8||||0.0129|TWO_SIDED|95.0|-5.1|-0.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.6|-5.1|0.0129
74044029|NCT02690168|147639010|OTHER|||||||0.0053|||||||t-test, 2 sided|||||||0.0053
74094948|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62||||0.079|TWO_SIDED|95.0|-0.07|1.32|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.32|-0.07|0.079
74094949|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.015|TWO_SIDED|95.0|0.12|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.12|0.015
74094950|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25|||<|0.001|TWO_SIDED|95.0|0.56|1.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.94|0.56|<0.001
74094951|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.438|TWO_SIDED|95.0|-0.29|0.67|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|-0.29|0.438
74044030|NCT02690168|147639011|OTHER|||||||0.477|||||||t-test, 2 sided|||||||0.477
74094952|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.001|TWO_SIDED|95.0|0.31|1.29|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.29|0.31|0.001
74094953|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06||||0.003|TWO_SIDED|95.0|0.37|1.75|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.75|0.37|0.003
74094954|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45||||0.204|TWO_SIDED|95.0|-0.25|1.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.14|-0.25|0.204
74094955|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.014|TWO_SIDED|95.0|0.12|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.12|0.014
74094956|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.018|TWO_SIDED|95.0|0.15|1.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.53|0.15|0.018
74094957|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.867|TWO_SIDED|95.0|-0.44|0.52|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|-0.44|0.867
74094958|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.099|TWO_SIDED|95.0|-0.08|0.9|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|-0.08|0.099
74044031|NCT02690168|147639012|OTHER|||||||0.917|||||||t-test, 2 sided|||||||0.917
74044032|NCT02690168|147639014|OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
74044033|NCT01961089|147639017|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test.||||||0.09|||||||Paired t-test|||P-value comparing AL between G6 and IOLM||||0.09
74044034|NCT01961089|147639017|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing AL between G6 and LS||||<0.001
74044035|NCT01961089|147639017|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing AL between IOLM and LS||||<0.0001
74044036|NCT01961089|147639017|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing CCT between G6 and LS||||<0.0001
74044037|NCT01961089|147639017|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing ACD between G6 and IOLM||||<0.0001
73880165|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.55||||0.6857|TWO_SIDED|95.0|0.03|9.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.97|0.03|0.6857
74044038|NCT01961089|147639017|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing ACD between G6 and LS||||<0.01
74044039|NCT01961089|147639017|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.02|||||||Paired t-test|||P-value comparing ACD between IOLM and LS||||0.02
74044040|NCT01961089|147639017|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing LT between G6 and LS||||<0.01
74044041|NCT01961089|147639017|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and IOLM||||<0.0001
74044042|NCT01961089|147639017|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and LS||||<0.0001
74044043|NCT01961089|147639017|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing WtW between IOLM and LS||||<0.001
74044044|NCT01961089|147639018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||ANOVA|||Repeatability was determined with random effect ANOVAs (estimates of random effects). They were calculated as the square root of the sum of the (Device x EyeID) interaction component plus (EyeID) and (Device) variance components plus the residual variance component. A (Device x Operator) interaction component was not assessed because each device was consistently operated by the same operator such that there was no Device x Operator interaction component. CV = Coefficient of Variation = SD/mean.||||0.05
74094959|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.024|TWO_SIDED|95.0|0.11|1.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.49|0.11|0.024
74094960|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.228|TWO_SIDED|95.0|-0.27|1.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.12|-0.27|0.228
73880166|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.56||||0.7291|TWO_SIDED|95.0|0.12|19.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.71|0.12|0.7291
74044045|NCT01961089|147639019|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.13|||||||Paired t-test|||P-value comparing SimK between G6 and IOLM||||0.13
74044046|NCT01961089|147639019|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.25|||||||Paired t-test|||P-value comparing SimK between G6 and LS||||0.25
74044047|NCT01961089|147639019|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.21|||||||Paired t-test|||P-value comparing SimK between IOLM and LS||||0.21
74044048|NCT04209400|147639030|NON_INFERIORITY|P \< 0.05 is considered a statistically significant difference in seroconversion between the two groups.||||||1|||||||Chi-squared|||The null hypothesis is that the vaccines equally affect the achievement of seroconversion level.||||1
74044049|NCT00383708|147639050|OTHER||||||<|0.0001|||||||Exact test|One-sided p value||The percentage of subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
74044050|NCT00383708|147639051|OTHER|||||||0.1654||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with pegvisomant (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.1654
74044051|NCT00383708|147639051|OTHER|||||||0.0115||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with lanreotide Autogel (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.0115
74044052|NCT00383708|147639051|OTHER|||||||0.0003||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with octreotide LAR (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.0003
74044053|NCT00383708|147639052|OTHER|||||||0.084||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.084
74044054|NCT00383708|147639052|OTHER||||||<|0.0001||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup non diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
74044055|NCT00383708|147639053|OTHER||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'while taking final dose during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
74044056|NCT00383708|147639053|OTHER||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'at any time during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
74044057|NCT01576406|147639083|SUPERIORITY||Geometric mean ratio|91.2|||||TWO_SIDED|90.0|57.47|144.72||||||Confidence interval (CI): Geometric mean ratio and 90 percent (%) CI were derived from analysis of variance (ANOVA) model.||144.72|57.47|
74044058|NCT01576406|147639083|SUPERIORITY||Geometric mean ratio|143.82|||||TWO_SIDED|90.0|89.11|232.12||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||232.12|89.11|
74044059|NCT01576406|147639083|SUPERIORITY||Geometric mean ratio|108.87|||||TWO_SIDED|90.0|70.13|168.99||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||168.99|70.13|
74044060|NCT01576406|147639083|SUPERIORITY||Geometric mean ratio|72.63|||||TWO_SIDED|90.0|49.07|107.5||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||107.50|49.07|
74094961|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.136|TWO_SIDED|95.0|-0.12|0.86|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|-0.12|0.136
74094962|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.078|TWO_SIDED|95.0|-0.07|1.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.28|-0.07|0.078
74094963|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.716|TWO_SIDED|95.0|-0.38|0.56|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.56|-0.38|0.716
74094964|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31||||0.197|TWO_SIDED|95.0|-0.16|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.79|-0.16|0.197
74094965|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.131|TWO_SIDED|95.0|-0.15|1.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|-0.15|0.131
74094966|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.399|TWO_SIDED|95.0|-0.39|0.97|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.97|-0.39|0.399
74094967|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.349|TWO_SIDED|95.0|-0.25|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.70|-0.25|0.349
74094968|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.169|TWO_SIDED|95.0|-0.2|1.12|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.12|-0.20|0.169
74044061|NCT01576406|147639109|SUPERIORITY||Percentage of ratio of geometric mean|91.12|||||TWO_SIDED|90.0|56.56|146.79||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||146.79|56.56|
74044062|NCT01576406|147639109|SUPERIORITY||Percentage of ratio of geometric mean|149.54|||||TWO_SIDED|90.0|91.85|243.46||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||243.46|91.85|
74044063|NCT01576406|147639109|SUPERIORITY||Percentage of ratio of geometric mean|114.08|||||TWO_SIDED|90.0|73.57|176.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||176.89|73.57|
74044064|NCT01576406|147639109|SUPERIORITY||Percentage of ratio of geometric mean|64.67|||||TWO_SIDED|90.0|39.5|105.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||105.89|39.50|
74044065|NCT01576406|147639110|SUPERIORITY||Percentage of ratio of geometric mean|108.43|||||TWO_SIDED|90.0|63.47|185.26||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||185.26|63.47|
74044066|NCT01576406|147639110|SUPERIORITY||Percentage of ratio of geometric mean|202.89|||||TWO_SIDED|90.0|120.96|340.3||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||340.30|120.96|
74044067|NCT01576406|147639110|SUPERIORITY||Percentage of ratio of geometric mean|130.78|||||TWO_SIDED|90.0|86.61|197.47||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||197.47|86.61|
74044068|NCT01576406|147639110|SUPERIORITY||Percentage of ratio of geometric mean|62.82|||||TWO_SIDED|90.0|42.54|92.78||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||92.78|42.54|
74044069|NCT01962688|147639125|OTHER|||||||0.002|||||||Chi-squared|||||||0.002
74044070|NCT00669032|147639129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|ONE_SIDED||||||Chi-squared|||||||0.004
74044071|NCT00669032|147639130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.525|TWO_SIDED||||||Chi-squared|||||||0.525
74044072|NCT00669032|147639131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||Chi-squared|||||||0.030
74044073|NCT00669032|147639132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
74044074|NCT00669032|147639133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
74044075|NCT00669032|147639134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
74044076|NCT00669032|147639135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
74094969|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.937|TWO_SIDED|95.0|-0.48|0.44|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|-0.48|0.937
74094970|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.351|TWO_SIDED|95.0|-0.25|0.69|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.69|-0.25|0.351
74094971|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.151|TWO_SIDED|95.0|-0.18|1.14|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.14|-0.18|0.151
74094972|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.476|TWO_SIDED|95.0|-0.42|0.9|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|-0.42|0.476
74094973|NCT02912650|147740351|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.31|TWO_SIDED|95.0|-0.22|0.71|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.71|-0.22|0.310
74014746|NCT00708123|147580402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|897.5|||<|0.0001|TWO_SIDED|95.0|739.92|1055.08||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors treatment, period and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1055.08|739.92|<0.0001
74014747|NCT00708123|147580402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|650.8|||<|0.0001|TWO_SIDED|95.0|493.61|808.0||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||808.00|493.61|<0.0001
74014748|NCT00708123|147580402|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|244.62||||0.0024|TWO_SIDED|95.0|87.62|401.61||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||401.61|87.62|0.0024
74014749|NCT01119248|147580420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|0.62|<|0.001|TWO_SIDED|95.0|-0.48|-0.25|||t-test, 2 sided|||||-0.25|-0.48|<.001
74014750|NCT01119248|147580421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.0001|TWO_SIDED|95.0|-0.95|-0.43|||t-test, 2 sided|||pre- MRI body temperature was associated with change in body temperature after MRI by bivariate analysis. The values presented are adjusted for body surface area, type of MRI, room temperature and duration of MRI||-0.43|-0.95|0.0001
74014751|NCT01119248|147580422|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
74014752|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.39|0.84|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.84|0.39|
74014753|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.54|1.01|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.01|0.54|
74014754|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.5|1.11|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.11|0.50|
74014755|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.38|0.9|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.90|0.38|
74044077|NCT00669032|147639136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|TWO_SIDED||||||Chi-squared|||||||0.025
74044078|NCT00669032|147639137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED||||||Chi-squared|||||||0.023
74044079|NCT00669032|147639138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
74094974|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|7.35|||<|0.001|TWO_SIDED|95.0|6.09|8.61|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||8.61|6.09|<0.001
74094975|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41||||0.002|TWO_SIDED|95.0|0.53|2.28|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.28|0.53|0.002
74094976|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|1.98|||<|0.001|TWO_SIDED|95.0|1.09|2.88|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.88|1.09|<0.001
73880167|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.82||||0.8951|TWO_SIDED|95.0|0.05|14.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||14.41|0.05|0.8951
74044080|NCT00669032|147639139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9129|TWO_SIDED||||||Chi-squared|||||||0.9129
74044081|NCT01375647|147639144|SUPERIORITY||Risk Difference (RD)|-2.9||||0.4|TWO_SIDED|95.0|-9.6|3.9|||Chi-squared|2 sided, not adjusted||||3.9|-9.6|0.4
74044082|NCT01375647|147639145|SUPERIORITY||Risk Difference (RD)|13.4||||4e-05|TWO_SIDED|95.0|7.0|19.8||2-sided, no adjustment|Chi-squared|||||19.8|7.0|0.00004
74044083|NCT01375647|147639146|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.5|TWO_SIDED||||||t-test, 2 sided|||Sabin type 1 shedding||||0.5
74044084|NCT01375647|147639146|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.2|TWO_SIDED||||||t-test, 2 sided|||Sabin type 2 shedding||||0.2
74044085|NCT01375647|147639146|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.1|TWO_SIDED||||||t-test, 2 sided|||Sabin type 3 shedding||||0.1
74044086|NCT01375647|147639148|SUPERIORITY||Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-7.3|4.5||||||Sabin type 1||4.5|-7.3|
74094977|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|5.94|||<|0.001|TWO_SIDED|95.0|4.69|7.2|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.20|4.69|<0.001
74094978|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37|||<|0.001|TWO_SIDED|95.0|4.1|6.63|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||6.63|4.10|<0.001
74094979|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58||||0.203|TWO_SIDED|95.0|-0.31|1.47|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.47|-0.31|0.203
74094980|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.001|TWO_SIDED|95.0|20.1|28.9|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||28.90|20.10|<0.001
74094981|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|4.44||||0.005|TWO_SIDED|95.0|1.37|7.52|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.52|1.37|0.005
74094982|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|11.36|||<|0.001|TWO_SIDED|95.0|8.23|14.48|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||14.48|8.23|<0.001
74044087|NCT01375647|147639148|SUPERIORITY||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.2|0.9||||||Sabin type 2||0.9|-7.2|
74044088|NCT01375647|147639148|SUPERIORITY||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-3.2|6.1||||||||6.1|-3.2|
74044089|NCT01375647|147639149|SUPERIORITY||Risk Difference (RD)|-33.7|||||TWO_SIDED|95.0|-40.7|-26.5||||||||-26.5|-40.7|
74044090|NCT01375647|147639149|SUPERIORITY||Risk Difference (RD)|-24.3|||||TWO_SIDED|95.0|-31.1|-17.5||||||||-17.5|-31.1|
74044091|NCT01375647|147639149|SUPERIORITY||Risk Difference (RD)|-45.6|||||TWO_SIDED|95.0|-52.6|-38.0||||||||-38.0|-52.6|
74044092|NCT01375647|147639150|SUPERIORITY|||||||0.981|||||||Wilcoxon (Mann-Whitney)|||||||0.981
74044093|NCT01375647|147639151|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74044094|NCT03366844|147639152|OTHER||Proportion|0.6|||||TWO_SIDED|95.0|0.465|0.724|||||95% confidence interval for one proportion were estimated using the Exact (Clopper-Pearson) method.|||0.724|0.465|
74044095|NCT00789724|147639158|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANOVA|||||||0.033
74044096|NCT02088541|147639177|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4221|TWO_SIDED|95.0|0.79|1.75|||Log Rank|||||1.75|0.79|0.4221
74044097|NCT02088541|147639178|SUPERIORITY|||||||0.9464|||||||Log Rank|||||||0.9464
74044098|NCT02088541|147639179|SUPERIORITY|||||||0.0986|||||||Cochran-Mantel-Haenszel|||||||0.0986
74044099|NCT02088541|147639181|SUPERIORITY|||||||0.0844|||||||Cochran-Mantel-Haenszel|||||||0.0844
74044100|NCT00323310|147639190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|1.46|<|0.0001|TWO_SIDED|95.0|1.1|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.5|1.1|<0.0001
74044101|NCT00323310|147639191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.45|<|0.0001|TWO_SIDED|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.9|<0.0001
74044102|NCT00323310|147639192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|1.42|<|0.0001|TWO_SIDED|95.0|0.4|0.9||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||0.9|0.4|<0.0001
74094983|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|20.06|||<|0.001|TWO_SIDED|95.0|15.66|24.45|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||24.45|15.66|<0.001
74094984|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|13.14|||<|0.001|TWO_SIDED|95.0|8.71|17.57|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||17.57|8.71|<0.001
74094985|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|6.92|||<|0.001|TWO_SIDED|95.0|3.8|10.04|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.04|3.80|<0.001
74094986|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|34.83|||<|0.001|TWO_SIDED|95.0|26.09|43.57|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||43.57|26.09|<0.001
74094987|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|5.85||||0.06|TWO_SIDED|95.0|-0.25|11.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||11.95|-0.25|0.060
74094988|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|16.75|||<|0.001|TWO_SIDED|95.0|10.54|22.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||22.95|10.54|<0.001
74014756|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.37|0.74|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.74|0.37|
74044103|NCT00323310|147639193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|1.56|<|0.001|TWO_SIDED|95.0|1.1|1.6||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.6|1.1|<0.001
74044104|NCT00323310|147639194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|1.49|<|0.001|TWO_SIDED|95.0|0.8|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.8|<0.001
74044105|NCT00323310|147639195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|1.2|<|0.0001|TWO_SIDED|95.0|0.4|0.8||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||0.8|0.4|<0.0001
74094989|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|28.98|||<|0.001|TWO_SIDED|95.0|20.26|37.71|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||37.71|20.26|<0.001
74094990|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|18.08|||<|0.001||95.0|9.29|26.88|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||26.88|9.29|<0.001
74094991|NCT02912650|147740352|SUPERIORITY_OR_OTHER||LS Mean Difference|10.9|||<|0.001|TWO_SIDED|95.0|4.7|17.1|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||17.10|4.70|<0.001
74094992|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|2.12|||<|0.001|TWO_SIDED|95.0|1.72|2.51|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.51|1.72|<0.001
74044106|NCT00323310|147639196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.57|<|0.0001|TWO_SIDED|95.0|1.0|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.5|1.0|<0.0001
74044107|NCT00323310|147639197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.49|<|0.0001|TWO_SIDED|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.9|<0.0001
74044108|NCT00323310|147639198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|1.54|<|0.0001|TWO_SIDED|95.0|0.6|1.1||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.1|0.6|<0.0001
74044109|NCT00446641|147639255|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.654||95.0|||||Chi-squared|||We assumed that the prevalence of AR would be 12 % among ischemic stroke patients who were treated with aspirin 100 per day. The prevalence could be reduced to 4% with additional cilostazol therapy||||0.654
74044110|NCT03961295|147639262|OTHER||Ratio of Geometric LSMs|1.2984|||||TWO_SIDED|90.0|1.0786|1.5486||||||Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.5486|1.0786|
74044111|NCT03961295|147639263|OTHER||Ratio of Geometric LSMs|1.3274|||||TWO_SIDED|90.0|1.1147|1.5807||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.5807|1.1147|
74044112|NCT03961295|147639264|OTHER||Ratio of Geometric LSMs|1.1978|||||TWO_SIDED|90.0|1.0394|1.3804||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.3804|1.0394|
74044113|NCT02707601|147639265|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
74044114|NCT02707601|147639265|SUPERIORITY|||||||0.042||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.042
74044115|NCT02707601|147639266|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
74044116|NCT02707601|147639266|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
74094993|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.002|TWO_SIDED|95.0|0.16|0.71|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.71|0.16|0.002
74094994|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|||<|0.001|TWO_SIDED|95.0|0.3|0.86|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.30|<0.001
73880168|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.66||||0.6865|TWO_SIDED|95.0|0.14|19.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.74|0.14|0.6865
74044117|NCT02707601|147639267|OTHER||Difference in Percentages|0.0||||1|TWO_SIDED|95.0|-6.1|6.1|||Fisher exact test||The differences in percentages of participants between treatment groups and their 95% confidence intervals (CIs) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||6.1|-6.1|1.00
74044118|NCT01391468|147639294|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
74044119|NCT01391468|147639295|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.744
74044120|NCT01391468|147639296|SUPERIORITY_OR_OTHER|||||||0.0042|TWO_SIDED|||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)|||||||0.0042
74044121|NCT01391468|147639297|SUPERIORITY_OR_OTHER|||||||0.0099|TWO_SIDED|||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)|||||||0.0099
74094995|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.68|||<|0.001|TWO_SIDED|95.0|1.29|2.08|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.08|1.29|<0.001
74094996|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.53|||<|0.001|TWO_SIDED|95.0|1.14|1.93|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.93|1.14|<0.001
74094997|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.303|TWO_SIDED|95.0|-0.13|0.43|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.13|0.303
74044122|NCT04839393|147639307|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|108.86|||||TWO_SIDED|90.0|87.24|135.84|||Mixed Models Analysis|||||135.84|87.24|
74044123|NCT04839393|147639308|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio|113.14|||||TWO_SIDED|90.0|89.34|143.28|||Mixed Models Analysis|||||143.28|89.34|
74044124|NCT04839393|147639309|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|38.73|||||TWO_SIDED|90.0|32.8|45.74|||Mixed Models Analysis|||The test treatment was PF-06865571 300 mg + PF-06882961 200 mg BID (Period 3 - Day 47), which was reported separately in comparison to the reference treatment of PF-06865571 300 mg (Period 1 - Day 1).||45.74|32.80|
74044125|NCT04839393|147639310|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|73.91|||||TWO_SIDED|90.0|67.95|80.4|||Mixed Models Analysis|||||80.40|67.95|
74044126|NCT04839393|147639311|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|73.2|||||TWO_SIDED|90.0|66.82|80.18|||Mixed Models Analysis|||||80.18|66.82|
74044127|NCT04839393|147639312|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|115.3|||||TWO_SIDED|90.0|85.37|155.73|||Mixed Models Analysis|||||155.73|85.37|
74044128|NCT04839393|147639313|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|118.64|||||TWO_SIDED|90.0|94.05|149.66|||Mixed Models Analysis|||||149.66|94.05|
74044129|NCT00608881|147639332|SUPERIORITY_OR_OTHER||π hat|0.494|||||TWO_SIDED|95.0|0.454|0.534|||||π hat is the estimate of the probability π that a randomly selected subject treated with CoQ has a better outcome than a randomly selected subject treated with placebo. Under the null hypothesis of no effect of CoQ, π = 0.50.|In this joint rank analysis, subjects are ranked from worst to best outcome with subjects who die being assigned the worst ranks (and ranked according to the time of death) and subjects who survive being ranked more favorably in the order of the change from baseline to Month 60 in TFC score.||0.534|0.454|
74044130|NCT00608881|147639333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.44|0.91||||||||0.91|-0.44|
74044131|NCT00608881|147639334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-1.4|1.58||||||||1.58|-1.40|
74044132|NCT00608881|147639335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.44|||||TWO_SIDED|95.0|-6.68|3.79||||||||3.79|-6.68|
74044133|NCT00608881|147639336|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|||||TWO_SIDED|95.0|-4.4|2.16||||||||2.16|-4.40|
74044134|NCT00608881|147639337|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-1.48|1.39||||||||1.39|-1.48|
74044135|NCT00608881|147639338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-4.78|3.23||||||||3.23|-4.78|
74044136|NCT00608881|147639339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||||TWO_SIDED|95.0|-1.32|2.14||||||||2.14|-1.32|
74044137|NCT00608881|147639340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.71|1.51||||||||1.51|-2.71|
74044138|NCT00608881|147639341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||||TWO_SIDED|95.0|-2.28|2.87||||||||2.87|-2.28|
74044139|NCT00608881|147639342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.88|||||TWO_SIDED|95.0|0.31|7.44||||||||7.44|0.31|
74044140|NCT00608881|147639343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.04|||||TWO_SIDED|95.0|-1.1|3.18||||||||3.18|-1.10|
74044141|NCT00608881|147639344|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.81|1.2||||||||1.20|0.81|
74044142|NCT00608881|147639345|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.75|1.15||||||||1.15|0.75|
74044143|NCT00633893|147639347|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3283|||<|0.0001|TWO_SIDED|95.0|0.2225|0.4844||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.4844|0.2225|<0.0001
74094998|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|7.22|||<|0.001|TWO_SIDED|95.0|5.86|8.58|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.58|5.86|<0.001
74094999|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.58||||0.001|TWO_SIDED|95.0|0.63|2.53|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.53|0.63|0.001
74095000|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|3.48|||<|0.001|TWO_SIDED|95.0|2.52|4.45|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.45|2.52|<0.001
74095001|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|||<|0.001|TWO_SIDED|95.0|4.28|6.99|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.99|4.28|<0.001
74095002|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|3.73|||<|0.001|TWO_SIDED|95.0|2.37|5.1|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.10|2.37|<0.001
74044144|NCT00633893|147639347|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3615|||<|0.0001|TWO_SIDED|95.0|0.2475|0.5281||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat principle.||0.5281|0.2475|<0.0001
74095003|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|||<|0.001|TWO_SIDED|95.0|0.95|2.86|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.86|0.95|<0.001
74095004|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|8.89|||<|0.001|TWO_SIDED|95.0|7.08|10.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.71|7.08|<0.001
74095005|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.002|TWO_SIDED|95.0|0.73|3.26|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.26|0.73|0.002
74095006|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|4.48|||<|0.001|TWO_SIDED|95.0|3.2|5.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.77|3.20|<0.001
74095007|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9|||<|0.001|TWO_SIDED|95.0|5.08|8.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.71|5.08|<0.001
74095008|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|4.41|||<|0.001|TWO_SIDED|95.0|2.58|6.24|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.24|2.58|<0.001
74095009|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|2.49|||<|0.001|TWO_SIDED|95.0|1.21|3.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.77|1.21|<0.001
74095010|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|10.42|||<|0.001|TWO_SIDED|95.0|7.76|13.08|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||13.08|7.76|<0.001
74095011|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|2.14||||0.024|TWO_SIDED|95.0|0.28|4.0|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.00|0.28|0.024
74095012|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|5.24|||<|0.001|TWO_SIDED|95.0|3.35|7.12|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.12|3.35|<0.001
74044145|NCT00633893|147639348|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2891|||<|0.0001|TWO_SIDED|95.0|0.1902|0.4395||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.4395|0.1902|<0.0001
74095013|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|8.28|||<|0.001|TWO_SIDED|95.0|5.62|10.93|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.93|5.62|<0.001
74095014|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|5.18|||<|0.001|TWO_SIDED|95.0|2.51|7.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.86|2.51|<0.001
74095015|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1||||0.001|TWO_SIDED|95.0|1.22|4.97|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.97|1.22|0.001
74095016|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|1.95|3.59|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.59|1.95|<0.001
74095017|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.023|TWO_SIDED|95.0|0.09|1.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.24|0.09|0.023
74095018|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|||<|0.001|TWO_SIDED|95.0|1.07|2.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.24|1.07|<0.001
74095019|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|||<|0.001|TWO_SIDED|95.0|1.29|2.92|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.92|1.29|<0.001
73888029|NCT01746901|147309531|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.0003|TWO_SIDED|95.0|2.0|6.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.5|2.0|0.0003
74095020|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.11||||0.008|TWO_SIDED|95.0|0.29|1.94|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.94|0.29|0.008
74095021|NCT02912650|147740353|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|||<|0.001|TWO_SIDED|95.0|0.41|1.57|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.57|0.41|<0.001
74095022|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|||<|0.001|TWO_SIDED|95.0|2.68|3.82|||ANOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.82|2.68|<0.001
74095023|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.002|TWO_SIDED|95.0|0.23|1.03|||ANOVA|||0-2 hour:Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.03|0.23|0.002
74095024|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|||<|0.001|TWO_SIDED|95.0|0.46|1.27|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.46|<0.001
74095025|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|2.62|||<|0.001|TWO_SIDED|95.0|2.05|3.19|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.19|2.05|<0.001
74095026|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|2.39|||<|0.001|TWO_SIDED|95.0|1.81|2.96|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.96|1.81|<0.001
74095027|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.258|TWO_SIDED|95.0|-0.17|0.64|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|-0.17|0.258
74095028|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|10.77|||<|0.001|TWO_SIDED|95.0|8.79|12.74|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.74|8.79|<0.001
74095029|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|2.29||||0.001|TWO_SIDED|95.0|0.91|3.67|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.67|0.91|0.001
74095030|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|5.33|||<|0.001|TWO_SIDED|95.0|3.93|6.73|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.73|3.93|<0.001
74095031|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|8.48|||<|0.001|TWO_SIDED|95.0|6.51|10.44|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.44|6.51|<0.001
74095032|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|5.44|||<|0.001|TWO_SIDED|95.0|3.46|7.42|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.42|3.46|<0.001
74095033|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|3.04|||<|0.001|TWO_SIDED|95.0|1.65|4.43|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.43|1.65|<0.001
74095034|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|14.68|||<|0.001|TWO_SIDED|95.0|10.74|18.62|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||18.62|10.74|<0.001
74095035|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|3.16||||0.024|TWO_SIDED|95.0|0.41|5.91|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.91|0.41|0.024
74095036|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|7.94|||<|0.001|TWO_SIDED|95.0|5.15|10.73|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.73|5.15|<0.001
74014757|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.52|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.02|0.52|
74044146|NCT00633893|147639348|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3774|||<|0.0001|TWO_SIDED|95.0|0.2577|0.5525||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.5525|0.2577|<0.0001
74044147|NCT00633893|147639349|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2422|||<|0.0001|TWO_SIDED|95.0|0.1476|0.3975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.3975|0.1476|<0.0001
74044148|NCT00633893|147639349|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.1861|||<|0.0001|TWO_SIDED|95.0|0.1062|0.3261||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.3261|0.1062|<0.0001
74044149|NCT00633893|147639350|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2799|||<|0.0001|TWO_SIDED|95.0|0.1844|0.4247||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.4247|0.1844|<0.0001
74044150|NCT00633893|147639350|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3653|||<|0.0001|TWO_SIDED|95.0|0.25|0.5338||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.5338|0.2500|<0.0001
74044151|NCT00633893|147639351|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2615|||<|0.0001|TWO_SIDED|95.0|0.1593|0.4292||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.4292|0.1593|<0.0001
74044152|NCT00633893|147639351|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3972|||<|0.0001|TWO_SIDED|95.0|0.2595|0.6079||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.6079|0.2595|<0.0001
74044153|NCT00633893|147639352|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6087||||0.1084|TWO_SIDED|95.0|0.3653|1.0145||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.0145|0.3653|0.1084
74095037|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|11.52|||<|0.001|TWO_SIDED|95.0|7.59|15.45|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||15.45|7.59|<0.001
73880169|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.17||||0.9132|TWO_SIDED|95.0|0.07|20.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||20.24|0.07|0.9132
74095038|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|6.75|||<|0.001||95.0|2.79|10.71|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.71|2.79|<0.001
74014758|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.46|0.95|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.95|0.46|
74044154|NCT00633893|147639352|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6846||||0.1329|TWO_SIDED|95.0|0.4164|1.1257||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1257|0.4164|0.1329
73880170|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.38||||0.7982|TWO_SIDED|95.0|0.12|16.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.59|0.12|0.7982
74014759|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.45|1.25|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.25|0.45|
74014760|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.54|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.02|0.54|
74044155|NCT00633893|147639353|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.647||||0.3059|TWO_SIDED|95.0|0.3543|1.1813||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1813|0.3543|0.3059
74044156|NCT00633893|147639353|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9416||||0.8288|TWO_SIDED|95.0|0.5458|1.6245||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.6245|0.5458|0.8288
74044157|NCT00633893|147639354|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5794||||0.1316|TWO_SIDED|95.0|0.3215|1.0443||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.0443|0.3215|0.1316
74095039|NCT02912650|147740354|SUPERIORITY_OR_OTHER||LS Mean Difference|4.78|||<|0.001|TWO_SIDED|95.0|2.0|7.56|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.56|2.0|<0.001
74095040|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37|||<|0.001|TWO_SIDED|95.0|4.42|6.32|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.32|4.42|<0.001
74095041|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.002|TWO_SIDED|95.0|0.4|1.74|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.74|0.40|0.002
73880171|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|1.17||||0.9029|TWO_SIDED|95.0|0.09|15.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||15.57|0.09|0.9029
73880172|NCT03192176|147297619|SUPERIORITY||Odds Ratio (OR)|0.69||||0.7971|TWO_SIDED|95.0|0.04|11.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||11.94|0.04|0.7971
74095042|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|0.77|2.13|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.13|0.77|<0.001
74095043|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|||<|0.001|TWO_SIDED|95.0|3.35|5.25|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.25|3.35|<0.001
74095044|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|||<|0.001|TWO_SIDED|95.0|2.96|4.88|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.88|2.96|<0.001
74044158|NCT00633893|147639354|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8433||||0.5288|TWO_SIDED|95.0|0.4959|1.4341||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.4341|0.4959|0.5288
74044159|NCT00633893|147639355|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6577||||0.2361|TWO_SIDED|95.0|0.3874|1.1169||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1169|0.3874|0.2361
74044160|NCT00633893|147639355|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7708||||0.3155|TWO_SIDED|95.0|0.4631|1.2832||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.2832|0.4631|0.3155
74044161|NCT00633893|147639357|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.485||||0.3925|TWO_SIDED|95.0|0.0891|2.6391||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Treated participants with at least one dose of study drug were included.||2.6391|0.0891|0.3925
74044162|NCT00633893|147639357|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2457||||0.3551|TWO_SIDED|95.0|0.0269|2.2437||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Participants treated with at least one dose of study drug were included.||2.2437|0.0269|0.3551
74044163|NCT00633893|147639358|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2027||||0.5148|TWO_SIDED|95.0|0.6897|2.0975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.||2.0975|0.6897|0.5148
74044164|NCT00633893|147639358|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.616||||0.1412|TWO_SIDED|95.0|0.9554|2.7336||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.||2.7336|0.9554|0.1412
74044165|NCT00633893|147639359|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2928||||0.3932|TWO_SIDED|95.0|0.7158|2.3348||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.||2.3348|0.7158|0.3932
74095045|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.268|TWO_SIDED|95.0|-0.29|1.05|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|-0.29|0.268
74095046|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|17.99|||<|0.001|TWO_SIDED|95.0|14.69|21.28|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||21.28|14.69|<0.001
74095047|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|||<|0.001|TWO_SIDED|95.0|1.57|6.17|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.17|1.57|<0.001
74095048|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|8.81|||<|0.001|TWO_SIDED|95.0|6.48|11.15|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||11.15|6.48|<0.001
74095049|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|14.12|||<|0.001|TWO_SIDED|95.0|10.83|17.4|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||17.40|10.83|<0.001
74095050|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|9.17|||<|0.001|TWO_SIDED|95.0|5.86|12.48|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.48|5.86|<0.001
74095051|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|4.94|||<|0.001|TWO_SIDED|95.0|2.62|7.27|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.27|2.62|<0.001
74095052|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|21.94|||<|0.001|TWO_SIDED|95.0|17.52|26.37|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||26.37|17.52|<0.001
74095053|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0||||0.002|TWO_SIDED|95.0|1.91|8.09|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.09|1.91|0.002
74095054|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|11.43|||<|0.001|TWO_SIDED|95.0|8.29|14.56|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||14.56|8.29|<0.001
74095055|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|16.94|||<|0.001|TWO_SIDED|95.0|12.53|21.36|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||21.36|12.53|<0.001
74095056|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|10.52|||<|0.001|TWO_SIDED|95.0|6.07|14.97|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||14.97|6.07|<0.001
74095057|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|6.43|||<|0.001|TWO_SIDED|95.0|3.3|9.55|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||9.55|3.30|<0.001
74095058|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|||<|0.001|TWO_SIDED|95.0|18.57|31.63|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||31.63|18.57|<0.001
74095059|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3||||0.023|TWO_SIDED|95.0|0.74|9.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||9.86|0.74|0.023
74095060|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|13.17|||<|0.001|TWO_SIDED|95.0|8.55|17.8|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||17.80|8.55|<0.001
74095061|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.28|26.31|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||26.31|13.28|<0.001
74095062|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|11.93|||<|0.001|TWO_SIDED|95.0|5.36|18.49|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||18.49|5.36|<0.001
74095063|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|7.87|||<|0.001|TWO_SIDED|95.0|3.27|12.48|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.48|3.27|<0.001
74095064|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|6.61|||<|0.001|TWO_SIDED|95.0|4.61|8.62|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.62|4.61|<0.001
74095065|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|1.74||||0.015|TWO_SIDED|95.0|0.34|3.14|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.14|0.34|0.015
74095066|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|4.34|||<|0.001|TWO_SIDED|95.0|2.92|5.76|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.76|2.92|<0.001
74095067|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|4.87|||<|0.001|TWO_SIDED|95.0|2.87|6.88|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.88|2.87|<0.001
74095068|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|2.27||||0.028|TWO_SIDED|95.0|0.25|4.28|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.28|0.25|0.028
74095069|NCT02912650|147740355|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61|||<|0.001|TWO_SIDED|95.0|1.19|4.02|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.02|1.19|<0.001
74095070|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.56|||<|0.001|TWO_SIDED|95.0|-49.41|-23.71|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-23.71|-49.41|<0.001
74095071|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.95||||0.086|TWO_SIDED|95.0|-8.45|0.56|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.56|-8.45|0.086
73888030|NCT01746901|147309531|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.5483|TWO_SIDED|95.0|-1.6|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-1.6|0.5483
74014761|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.35|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.79|0.35|
74014762|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.34|0.67|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.67|0.34|
74014763|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.37|0.88|||||Confidence intervals for the ratio are back transformation of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.88|0.37|
74014764|NCT00562354|147580427|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.3|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.79|0.30|
74014765|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|-4.9|||||TWO_SIDED|95.0|-12.1|2.0||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.0|-12.1|
74014766|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|-3.9|||||TWO_SIDED|95.0|-11.6|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.5|-11.6|
74014767|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.6|2.2||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.2|-9.6|
74014768|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|-5.5|||||TWO_SIDED|95.0|-13.7|2.5||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.5|-13.7|
74014769|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|-1.5|||||TWO_SIDED|95.0|-5.7|2.1||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-5.7|
74014770|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|-1.6|||||TWO_SIDED|95.0|-5.9|2.1||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-5.9|
74095072|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.71||||0.112|TWO_SIDED|95.0|-8.28|0.86|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.86|-8.28|0.112
74095073|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-32.52|||<|0.001|TWO_SIDED|95.0|-45.86|-19.17|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.17|-45.86|<0.001
74014771|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|-5.3|||||TWO_SIDED|95.0|-10.8|-0.9||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-0.9|-10.8|
74014772|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|-0.8|||||TWO_SIDED|95.0|-8.7|6.9||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.9|-8.7|
74014773|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-4.0|4.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.1|-4.0|
74014774|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.6|2.5||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.5|-7.6|
74014775|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|0.8|||||TWO_SIDED|95.0|-2.8|4.7||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.7|-2.8|
74095074|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-32.88|||<|0.001|TWO_SIDED|95.0|-46.22|-19.55|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.55|-46.22|<0.001
74095075|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|0.11||||0.968|TWO_SIDED|95.0|-5.2|5.42|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||5.42|-5.20|0.968
74044166|NCT00633893|147639359|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8235||||0.0621||95.0|1.047|3.176||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.||3.1760|1.0470|0.0621
74044167|NCT00633893|147639360|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2579||||0.1691|TWO_SIDED|95.0|0.9064|1.7457||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.||1.7457|0.9064|0.1691
74044168|NCT00633893|147639360|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6971||||0.0013|TWO_SIDED|95.0|1.2468|2.3102||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.||2.3102|1.2468|0.0013
74044169|NCT00633893|147639361|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2374||||0.1466|TWO_SIDED|95.0|0.9276|1.6507||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding.||1.6507|0.9276|0.1466
74044170|NCT00633893|147639361|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6468||||0.0005|TWO_SIDED|95.0|1.2552|2.1606||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding is any major, clinically relevant non-major, or minor bleeding.||2.1606|1.2552|0.0005
74044171|NCT02911519|147639409|SUPERIORITY||Risk Ratio (RR)|0.95||||0.59|TWO_SIDED|95.0|0.77|1.16|||Mixed Models Analysis||This is intention-to-treat analysis. The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk.|||1.16|0.77|0.59
74044172|NCT02911519|147639410|SUPERIORITY||Risk Ratio (RR)|0.98||||0.73|TWO_SIDED|95.0|0.87|1.1|||Mixed Models Analysis||The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk. This is intention-to-treat analysis.|||1.10|0.87|0.73
74044173|NCT02911519|147639411|SUPERIORITY||Slope|0.01||||0.94|TWO_SIDED|95.0|-0.36|0.39|||Mixed Models Analysis||This is intention-to-treat analysis.|||0.39|-0.36|0.94
74044174|NCT02911519|147639411|SUPERIORITY||Slope|-0.19||||0.3|TWO_SIDED|95.0|-0.57|0.18|||Mixed Models Analysis||This is intention-to-treat analysis.|||0.18|-0.57|0.30
74044175|NCT02911519|147639413|SUPERIORITY||Slope|0.03||||0.61|TWO_SIDED|95.0|-0.1|0.17|||Mixed Models Analysis||This is an intention to treat analysis.|||0.17|-0.10|0.61
74044176|NCT02911519|147639414|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.|Slope|0.04||||0.81|TWO_SIDED|95.0|-0.38|0.3|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.|||0.30|-0.38|0.81
74044177|NCT02911519|147639414|SUPERIORITY|This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.|Slope|-0.04||||0.81|TWO_SIDED|95.0|-0.38|0.29|||Mixed Models Analysis||This is an intention to treat analysis.This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.|||0.29|-0.38|0.81
74044178|NCT02911519|147639414|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.|Slope|0.16||||0.52|TWO_SIDED|95.0|-0.33|0.65|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.|||0.65|-0.33|0.52
74044179|NCT02911519|147639414|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.|Slope|0.19||||0.27|TWO_SIDED|95.0|-0.15|0.53|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.|||0.53|-0.15|0.27
74044180|NCT02911519|147639415|SUPERIORITY|This analysis applies to SSFB objective domain in the first row.|Slope|-0.01||||0.33|TWO_SIDED|95.0|-0.01|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB objective domain in the first row.|||0.01|-0.01|0.33
74095076|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.88|||<|0.001|TWO_SIDED|95.0|-61.18|-34.58|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-34.58|-61.18|<0.001
74095077|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.23||||0.023|TWO_SIDED|95.0|-11.61|-0.84|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.84|-11.61|0.023
74095078|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.23||||0.026|TWO_SIDED|95.0|-11.73|-0.73|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.73|-11.73|0.026
74095079|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-41.51|||<|0.001|TWO_SIDED|95.0|-55.51|-27.52|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-27.52|-55.51|<0.001
74095080|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-41.77|||<|0.001|TWO_SIDED|95.0|-55.65|-27.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-27.89|-55.65|<0.001
74095081|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.16||||0.96|TWO_SIDED|95.0|-6.56|6.23|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||6.23|-6.56|0.960
73880173|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|0.67||||0.7899|TWO_SIDED|95.0|0.04|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.34|0.04|0.7899
74044181|NCT02911519|147639415|SUPERIORITY|This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.|Slope|-0.01||||0.19|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.|||0.01|-0.02|0.19
74044182|NCT02911519|147639416|SUPERIORITY||Slope|0.01||||0.97|TWO_SIDED|95.0|-0.19|0.19|||Mixed Models Analysis||This is an intention to treat analysis.|||0.19|-0.19|0.97
74044183|NCT00407550|147639426|SUPERIORITY|||||||0.015|||||||Log Rank|||||||0.015
74044184|NCT00407550|147639427|SUPERIORITY|||||||0.56|||||||Log Rank|||||||0.56
74044185|NCT01444898|147639434|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||.07
74044186|NCT01444898|147639435|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.08
74095082|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-55.73|||<|0.001|TWO_SIDED|95.0|-68.81|-42.65|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-42.65|-68.81|<0.001
74044187|NCT01444898|147639436|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||.8
74095083|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.16||||0.055|TWO_SIDED|95.0|-12.46|0.13|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.13|-12.46|0.055
74095084|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.7||||0.001|TWO_SIDED|95.0|-18.7|-4.7|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-4.70|-18.70|0.001
74095085|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-49.41|||<|0.001|TWO_SIDED|95.0|-63.21|-35.6|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-35.60|-63.21|<0.001
74095086|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-44.3|||<|0.001|TWO_SIDED|95.0|-58.04|-30.55|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-30.55|-58.04|<0.001
74095087|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-5.69||||0.151|TWO_SIDED|95.0|-13.46|2.08|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.08|-13.46|0.151
74095088|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-56.94|||<|0.001|TWO_SIDED|95.0|-69.96|-43.91|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-43.91|-69.96|<0.001
74095089|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-9.0||||0.01|TWO_SIDED|95.0|-15.8|-2.19|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.19|-15.80|0.010
74044188|NCT01444898|147639437|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
74044189|NCT01444898|147639438|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||.8
74044190|NCT01444898|147639439|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||.2
74044191|NCT01444898|147639440|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||.2
74044192|NCT01444898|147639441|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
74044193|NCT01444898|147639442|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||.004
74044194|NCT02580591|147639444|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|99.0|-0.46|-0.11|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.11|-0.46|<0.0001
74014776|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.7||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.7|-8.8|
74014777|NCT00562354|147580430|SUPERIORITY_OR_OTHER||difference in proportions|-6.2|||||TWO_SIDED|95.0|-14.1|1.5||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.5|-14.1|
74014778|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-7.2|||||TWO_SIDED|95.0|-15.1|0.3||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||0.3|-15.1|
74014779|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-5.4|||||TWO_SIDED|95.0|-14.5|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.5|-14.5|
74014780|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-11.2|||||TWO_SIDED|95.0|-21.4|-1.0||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.0|-21.4|
74044195|NCT02580591|147639444|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.6|-0.3|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.30|-0.60|<0.0001
74044196|NCT02580591|147639444|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.68|-0.37|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.37|-0.68|<0.0001
74044197|NCT02580591|147639445|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.4|-0.14|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.14|-0.40|
74095090|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.11|||<|0.001|TWO_SIDED|95.0|-27.97|-12.24|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-12.24|-27.97|<0.001
74095091|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.73|||<|0.001|TWO_SIDED|95.0|-61.64|-33.83|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-33.83|-61.64|<0.001
74095092|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-37.18|||<|0.001|TWO_SIDED|95.0|-50.96|-23.4|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-23.40|-50.96|<0.001
74095093|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.19||||0.013|TWO_SIDED|95.0|-20.02|-2.36|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.36|-20.02|0.013
73880174|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|0.86||||0.9186|TWO_SIDED|95.0|0.05|14.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.73|0.05|0.9186
73880175|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|2.19||||0.5303|TWO_SIDED|95.0|0.19|25.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||25.46|0.19|0.5303
74014781|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-4.7|||||TWO_SIDED|95.0|-13.5|3.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.9|-13.5|
74014782|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-5.1|||||TWO_SIDED|95.0|-14.3|4.0||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.0|-14.3|
74014783|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-12.9|||||TWO_SIDED|95.0|-24.6|-0.8||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-0.8|-24.6|
74095094|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-58.14|||<|0.001|TWO_SIDED|95.0|-71.03|-45.26|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-45.26|-71.03|<0.001
74095095|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.15||||0.005|TWO_SIDED|95.0|-17.24|-3.06|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.06|-17.24|0.005
74095096|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.77|||<|0.001|TWO_SIDED|95.0|-35.1|-18.44|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-18.44|-35.10|<0.001
74095097|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.74|||<|0.001|TWO_SIDED|95.0|-61.76|-33.72|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-33.72|-61.76|<0.001
74095098|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-31.69|||<|0.001|TWO_SIDED|95.0|-45.61|-17.76|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.76|-45.61|<0.001
74095099|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.76|||<|0.001|TWO_SIDED|95.0|-26.1|-7.42|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.42|-26.10|<0.001
74095100|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-57.58|||<|0.001|TWO_SIDED|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-44.72|-70.44|<0.001
74095101|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.28||||0.004|TWO_SIDED|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.57|-18.99|0.004
74095102|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-28.06|||<|0.001|TWO_SIDED|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.35|-36.77|<0.001
74095103|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-46.01|||<|0.001|TWO_SIDED|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-32.04|-59.98|<0.001
74095104|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-29.7|||<|0.001|TWO_SIDED|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-15.75|-43.65|<0.001
74095105|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.94|||<|0.001|TWO_SIDED|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.29|-26.59|<0.001
73880176|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|5.85||||0.1149|TWO_SIDED|95.0|0.65|52.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||52.66|0.65|0.1149
74095106|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-52.9|||<|0.001|TWO_SIDED|95.0|-66.06|-39.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-39.75|-66.06|<0.001
74095107|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.93||||0.042|TWO_SIDED|95.0|-17.53|-0.34|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.34|-17.53|0.042
74095108|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-27.25|||<|0.001|TWO_SIDED|95.0|-36.65|-17.86|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.86|-36.65|<0.001
74095109|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-43.78|||<|0.001|TWO_SIDED|95.0|-57.83|-29.72|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-29.72|-57.83|<0.001
74095110|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-25.75|||<|0.001|TWO_SIDED|95.0|-39.93|-11.57|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-11.57|-39.93|<0.001
74095111|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.49|||<|0.001|TWO_SIDED|95.0|-28.39|-8.59|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-8.59|-28.39|<0.001
74095112|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-45.27|||<|0.001|TWO_SIDED|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-31.58|-58.96|<0.001
74014784|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-7.3|||||TWO_SIDED|95.0|-16.3|1.5||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.5|-16.3|
74095113|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.88||||0.064|TWO_SIDED|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.50|-18.27|0.064
74095114|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.98|||<|0.001|TWO_SIDED|95.0|-36.91|-17.05|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.05|-36.91|<0.001
74095115|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.26|||<|0.001|TWO_SIDED|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-22.07|-50.45|<0.001
74014785|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-17.5|||||TWO_SIDED|95.0|-29.5|-5.0||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-5.0|-29.5|
74014786|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-9.6|||||TWO_SIDED|95.0|-21.4|2.4||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.4|-21.4|
74014787|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-10.5|||||TWO_SIDED|95.0|-19.3|-1.3||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.3|-19.3|
74014788|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|0.8|||||TWO_SIDED|95.0|-6.2|7.9||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||7.9|-6.2|
74014789|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-3.8|||||TWO_SIDED|95.0|-12.2|4.5||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.5|-12.2|
74014790|NCT00562354|147580433|SUPERIORITY_OR_OTHER||difference in proportions|-2.5|||||TWO_SIDED|95.0|-12.5|7.3||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||7.3|-12.5|
74014791|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-5.7|||||TWO_SIDED|95.0|-13.8|2.1||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-13.8|
74014792|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-5.5|||||TWO_SIDED|95.0|-15.9|5.0||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||5.0|-15.9|
74014793|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-18.3|||||TWO_SIDED|95.0|-30.1|-5.9||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-5.9|-30.1|
74014794|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-2.3|||||TWO_SIDED|95.0|-11.6|6.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.9|-11.6|
74014795|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-11.9|||||TWO_SIDED|95.0|-22.6|-1.2||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.2|-22.6|
74014796|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-11.0|||||TWO_SIDED|95.0|-23.8|1.9||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.9|-23.8|
74014797|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-9.5|||||TWO_SIDED|95.0|-19.3|0.4||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||0.4|-19.3|
74014798|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-26.9|||||TWO_SIDED|95.0|-39.0|-14.1||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-14.1|-39.0|
74014799|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-6.4|||||TWO_SIDED|95.0|-18.7|6.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.1|-18.7|
74014800|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-12.2|||||TWO_SIDED|95.0|-22.6|-1.7||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.7|-22.6|
74014801|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-0.8|||||TWO_SIDED|95.0|-9.8|8.1||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||8.1|-9.8|
74014802|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-11.4|||||TWO_SIDED|95.0|-21.7|-1.2||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.2|-21.7|
74014803|NCT00562354|147580436|SUPERIORITY_OR_OTHER||difference in proportions|-7.7|||||TWO_SIDED|95.0|-18.5|3.4||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.4|-18.5|
74014804|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.6|||||TWO_SIDED|95.0|0.43|0.86|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.86|0.43|
74014805|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.8|||||TWO_SIDED|95.0|0.63|1.0|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.00|0.63|
74014806|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.66|||||TWO_SIDED|95.0|0.48|0.91|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.91|0.48|
74014807|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.65|||||TWO_SIDED|95.0|0.5|0.85|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.85|0.50|
74014808|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.71|||||TWO_SIDED|95.0|0.52|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.97|0.52|
74014809|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.65|||||TWO_SIDED|95.0|0.48|0.9|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.90|0.48|
74014810|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.74|||||TWO_SIDED|95.0|0.56|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.97|0.56|
74014811|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.46|||||TWO_SIDED|95.0|0.35|0.61|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.61|0.35|
74014812|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.76|||||TWO_SIDED|95.0|0.56|1.03|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.03|0.56|
74095116|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.58||||0.01|TWO_SIDED|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-4.52|-32.64|0.010
74014813|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.57|||||TWO_SIDED|95.0|0.43|0.74|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.74|0.43|
74014814|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.5|||||TWO_SIDED|95.0|0.38|0.66|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.66|0.38|
74095117|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.17|||<|0.001|TWO_SIDED|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.90|-28.44|<0.001
73880177|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|9.07||||0.0442|TWO_SIDED|95.0|1.06|77.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||77.71|1.06|0.0442
74014815|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.42|||||TWO_SIDED|95.0|0.29|0.6|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.60|0.29|
74014816|NCT00562354|147580439|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.59|||||TWO_SIDED|95.0|0.42|0.82|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.82|0.42|
74014817|NCT01883635|147580462|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.14
74014818|NCT01883635|147580463|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.65
74014819|NCT01883635|147580464|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.51
74095118|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-34.21|||<|0.001|TWO_SIDED|95.0|-48.21|-20.21|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-20.21|-48.21|<0.001
74095119|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.97||||0.179|TWO_SIDED|95.0|-17.12|3.19|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.19|-17.12|0.179
74095120|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.7|||<|0.001|TWO_SIDED|95.0|-31.04|-10.35|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-10.35|-31.04|<0.001
74095121|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-27.2|||<|0.001|TWO_SIDED|95.0|-41.44|-12.96|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-12.96|-41.44|<0.001
73880178|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.53||||0.2851|TWO_SIDED|95.0|0.35|35.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||35.68|0.35|0.2851
73880179|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|4.22||||0.2073|TWO_SIDED|95.0|0.45|39.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||39.48|0.45|0.2073
73880180|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.68||||0.27|TWO_SIDED|95.0|0.36|37.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||37.16|0.36|0.2700
73880181|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.41||||0.2982|TWO_SIDED|95.0|0.34|34.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||34.27|0.34|0.2982
74014820|NCT03649061|147580467|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||To compare the two randomization groups, a linear mixed model with DAS28-CRP as outcome (Bell et al. 2014), including random intercepts per patient, adjusted for baseline DAS28-CRP, randomization timepoint, and RF and/or ACPA seropositivity was used.||||<0.05
74014821|NCT03649061|147580468|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||A binomial generalized linear mixed effect model for repeated measures of remission from randomization up until 28 weeks after was carried out, with adjustment for baseline DAS28-CRP, moment of randomization, and RF and/or ACPA seropositivity.||||<0.05
74014822|NCT00802204|147580480|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|describe.....||Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD||||<0.05
74014823|NCT00802204|147580480|OTHER||||||<|0.05|||||||t-test, 2 sided|||Paired t-test to compare baseline and post-diet outcome measures||||<0.05
74095122|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.9||||0.051|TWO_SIDED|95.0|-27.84|0.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.04|-27.84|0.051
74095123|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.76||||0.01|TWO_SIDED|95.0|-24.21|-3.31|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.31|-24.21|0.010
74095124|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-23.25||||0.001|TWO_SIDED|95.0|-37.31|-9.2|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-9.20|-37.31|0.001
73880182|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|12.3||||0.0204|TWO_SIDED|95.0|1.47|102.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||102.6|1.47|0.0204
74044198|NCT02580591|147639445|SUPERIORITY||Median Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.59|-0.28|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.28|-0.59|<0.0001
74044199|NCT02580591|147639445|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.66|-0.35|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.35|-0.66|<0.0001
74044200|NCT02580591|147639446|SUPERIORITY||Adjusted Rate Ratio (%)|0.94|||||TWO_SIDED|95.0|0.673|1.314|||Negative binomial model||Empagliflozin 2.5 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.314|0.673|
74044201|NCT02580591|147639446|SUPERIORITY||Adjusted Rate Ratio (%)|1.202||||0.2752|TWO_SIDED|97.75|0.818|1.766|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.766|0.818|0.2752
74044202|NCT02580591|147639446|SUPERIORITY||Adjusted Rate Ratio (%)|1.02||||0.9077|TWO_SIDED|97.75|0.693|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.501|0.693|0.9077
74044203|NCT02580591|147639446|SUPERIORITY||Adjusted Rate Ratio (%)|0.932|||||TWO_SIDED|95.0|0.682|1.274|||Negative binomial model|||For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.274|0.682|
74044204|NCT02580591|147639446|SUPERIORITY||Adjusted Rate Ratio (%)|1.258||||0.1438|TWO_SIDED|95.0|0.925|1.713||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.713|0.925|0.1438
74044205|NCT02580591|147639446|SUPERIORITY||Adjusted Rate Ratio (%)|1.051||||0.7543|TWO_SIDED|95.0|0.771|1.433||This is a nominal p-value.|Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.433|0.771|0.7543
74044206|NCT02580591|147639447|SUPERIORITY||Mean Difference (Final Values)|-1.76|||||TWO_SIDED|95.0|-2.32|-1.2|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.20|-2.32|
74044207|NCT02580591|147639447|SUPERIORITY||Mean Difference (Final Values)|-3.04|||<|0.0001|TWO_SIDED|99.75|-3.91|-2.18|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.18|-3.91|<0.0001
73880183|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|11.1||||0.027|TWO_SIDED|95.0|1.31|93.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||93.74|1.31|0.0270
74044208|NCT02580591|147639447|SUPERIORITY||Mean Difference (Final Values)|-3.43|||<|0.0001|TWO_SIDED|99.75|-4.3|-2.57|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.57|-4.30|<0.0001
74095125|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-2.22||||0.676|TWO_SIDED|95.0|-12.63|8.19|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.19|-12.63|0.676
73880184|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|2.22||||0.5224|TWO_SIDED|95.0|0.19|25.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.68|0.19|0.5224
73880185|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|4.92||||0.1635|TWO_SIDED|95.0|0.52|46.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||46.35|0.52|0.1635
74014824|NCT02701387|147580487|SUPERIORITY_OR_OTHER||||||<|0.01||||||"A 2-factor (implant type x time interval) nonparametric analysis for longitudinal data (Brunner et al. 2002) was used to compare test and control implants across time (baseline + four intervals). The R package nparLD was used (Noguchi et al. 2012)."|nonparametric for longitudinal|||Comparison of ISQ over time. Due to the high number of intervals (T0-T8) relative to the number of observations, data were combined for analysis purposes into 5 comparable intervals as follows: Baseline (T0, unchanged); Tr1=Average of follow-up weeks T1 and T2, Tr2=Average of follow-up weeks T3 and T4; Tr3=Average of follow-up weeks T5 and T6; Tr4=Average of follow-up weeks T7 and T8||||<0.01
74014825|NCT00631748|147580490|SUPERIORITY_OR_OTHER||||||<|0.25|TWO_SIDED|95.0|||||ANCOVA|We compared TLFB at baseline and at end of study.||We used a repeated-measures ANCOVA to compare cocaine usage between the two groups. This incorporated the multiple administrations of the Timeline Followback measure.||||<0.25
74014826|NCT00631748|147580491|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Regression, Cox|||End-of-trial abstinence was defined as a negative urine drug screen (for cocaine) for three consecutive weeks at the end of the study.||||.65
74014827|NCT00562588|147580522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.067||||0.683||95.0|0.78|1.461|||Regression, Logistic|||The primary endpoint tele-mRS on day 90 was available in 527 of 543 treated patients (97.1%).||1.461|0.78|0.683
74014828|NCT00562588|147580523|SUPERIORITY_OR_OTHER|||||||0.607||95.0|||||ANCOVA|ANCOVA with factors for treatment, age, weight, baseline SBP, diabetes, previous stroke and baseline NIHSS||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono||||0.607
74014829|NCT00562588|147580524|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725||||0.202||95.0|0.442|1.189|||Cox proportional hazards model|||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono||1.189|0.442|0.202
74044209|NCT02580591|147639448|SUPERIORITY||Mean Difference (Final Values)|-0.049|||||TWO_SIDED|95.0|-0.069|-0.03|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.030|-0.069|
74014830|NCT00313209|147580534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|27.0|71.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||71|27|<0.0001
74044210|NCT02580591|147639448|SUPERIORITY||Mean Difference (Final Values)|-0.07|||<|0.0001|TWO_SIDED|99.75|-0.101|-0.039|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.039|-0.101|<0.0001
74044211|NCT02580591|147639448|SUPERIORITY||Mean Difference (Final Values)|-0.091|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|99.75|-0.122|-0.06|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.060|-0.122|<0.0001
73888031|NCT01746901|147309531|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.5284|TWO_SIDED|95.0|-1.5|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-1.5|0.5284
74014831|NCT00313209|147580535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|60.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|38.0|82.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||82|38|<0.0001
74014832|NCT00313209|147580536|SUPERIORITY_OR_OTHER||Rate ratio|0.79|STANDARD_ERROR_OF_MEAN|0.12||0.1408|TWO_SIDED|95.0|0.58|1.08||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||1.08|0.58|0.1408
74014833|NCT00313209|147580537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.4654|TWO_SIDED|95.0|-0.2|0.4||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||0.4|-0.2|0.4654
74014834|NCT00313209|147580538|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.9||0.5457|TWO_SIDED|95.0|-1.2|2.2||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||2.2|-1.2|0.5457
74014835|NCT01332357|147580539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.56|2.46||The unadjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox|||||2.46|1.56|<0.0001
74014836|NCT01332357|147580539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.42|2.25||The adjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox|Covariates included demographics, IP or ED index event, primary asthma diagnosis, Charlson score, and pre-index medication||||2.25|1.42|<0.0001
74014837|NCT01332357|147580539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008|||<|0.0001|TWO_SIDED|95.0|1.005|1.011||The risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge by time interaction|Regression, Cox|Evaluates the impact of each day treatment with a controller was delayed||||1.011|1.005|<0.0001
74014838|NCT04099251|147580545|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.59|||Regression, Cox|||||0.59|0.30|< 0.0001
74014839|NCT05032157|147580557|SUPERIORITY||Mean Difference (Final Values)|-7.68|STANDARD_ERROR_OF_MEAN|1.136|<|0.001|TWO_SIDED|95.0|-9.91|-5.46|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, week, baseline score and both interaction of treatment by week and interaction of baseline score by week.|UAS7 at Week 12 (Scenario 1 with UAS7 as primary efficacy endpoint)||-5.46|-9.91|< 0.001
74014840|NCT05032157|147580558|SUPERIORITY||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|0.545|<|0.001|TWO_SIDED|95.0|-4.29|-2.16|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti- IgE, biologics, week, baseline score, and both interaction of treatment by week and interaction of baseline score by week.|ISS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-2.16|-4.29|<0.001
74044212|NCT02580591|147639449|SUPERIORITY||Median Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-3.9|-0.2|||Mixed effect Model Repeat MeasurementMix||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.2|-3.9|
74044213|NCT02580591|147639449|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.0001|TWO_SIDED|99.75|-6.8|-1.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, , treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.1|-6.8|<0.0001
74044214|NCT02580591|147639449|SUPERIORITY||Mean Difference (Final Values)|-3.7|||<|0.0001|TWO_SIDED|99.75|-6.6|-0.9|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.9|-6.6|<0.0001
74044215|NCT02580591|147639449|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.5|0.9|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.9|-1.5|
74044216|NCT02580591|147639449|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.0047|TWO_SIDED|99.75|-3.6|0.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.1|-3.6|0.0047
74044217|NCT02580591|147639449|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.0202|TWO_SIDED|99.75|-3.3|0.4|||Mixed effect Model Repeat Measurement|||For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.4|-3.3|0.0202
74044218|NCT03051217|147639455|SUPERIORITY||Estimated difference in responder rate|65.1|||||TWO_SIDED|95.0|48.22|81.9|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||81.90|48.22|
73880186|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|10.97||||0.0266|TWO_SIDED|95.0|1.32|91.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||91.15|1.32|0.0266
74014841|NCT05032157|147580559|SUPERIORITY||Mean Difference (Final Values)|-4.47|STANDARD_ERROR_OF_MEAN|0.634|<|0.001|TWO_SIDED|95.0|-5.71|-3.23|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti- IgE biologics, week, baseline score and both interaction of treatment by week and interaction of baseline score by week.|HSS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-3.23|-5.71|< 0.001
74014842|NCT05032157|147580560|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.39|6.18|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Disease activity control (UAS7 =\< 6) at Week 12||6.18|2.39|< 0.001
74044219|NCT03051217|147639455|SUPERIORITY||Estimated difference in responder rate|79.1|||||TWO_SIDED|95.0|65.1|93.17|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||93.17|65.10|
74044220|NCT03051217|147639455|SUPERIORITY||Odds Ratio (OR)|31.695|||<|0.0001|TWO_SIDED|97.5|5.129|195.877||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||195.877|5.129|<0.0001
74044221|NCT03051217|147639455|SUPERIORITY||Odds Ratio (OR)|79.112|||<|0.0001|TWO_SIDED|97.5|11.739|533.168||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||533.168|11.739|<0.0001
74044222|NCT03051217|147639456|SUPERIORITY||Estimated difference in responder rate|52.7|||||TWO_SIDED|95.0|29.95|75.39|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||75.39|29.95|
74044223|NCT03051217|147639456|SUPERIORITY||Estimated difference in responder rate|66.7|||||TWO_SIDED|95.0|43.34|90.15|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||90.15|43.34|
74044224|NCT03051217|147639456|SUPERIORITY||Odds Ratio (OR)|38.193|||<|0.0001|TWO_SIDED|97.5|6.113|238.619||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||238.619|6.113|<0.0001
74044225|NCT03051217|147639456|SUPERIORITY||Odds Ratio (OR)|69.58|||<|0.0001|TWO_SIDED|97.5|11.138|434.659||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||434.659|11.138|<0.0001
74095126|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.15||||0.013|TWO_SIDED|95.0|-23.57|-2.74|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.74|-23.57|0.013
74095127|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.94||||0.004|TWO_SIDED|95.0|-35.18|-6.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-6.69|-35.18|0.004
74095128|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.39||||0.14|TWO_SIDED|95.0|-24.19|3.4|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.40|-24.19|0.140
74044226|NCT03051217|147639457|SUPERIORITY||Estimated difference in responder rate|53.6|||||TWO_SIDED|95.0|30.67|76.47|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||76.47|30.67|
74044227|NCT03051217|147639457|SUPERIORITY||Estimated difference in responder rate|75.5|||||TWO_SIDED|95.0|51.95|99.04|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||99.04|51.95|
74014843|NCT05032157|147580561|SUPERIORITY||Odds Ratio (OR)|5.78|||<|0.001|TWO_SIDED|95.0|2.83|11.78|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Complete absence of hives and itch (UAS7 = 0) at Week 12||11.78|2.83|< 0.001
74014844|NCT05032157|147580562|SUPERIORITY||Odds Ratio (OR)|7.92|||<|0.001|TWO_SIDED|95.0|3.72|16.85|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Early onset of disease activity control (UAS7 =\< 6) at Week 2||16.85|3.72|< 0.001
74014845|NCT05032157|147580563|SUPERIORITY||Odds Ratio (OR)|2.75|||<|0.001|TWO_SIDED|95.0|1.65|4.58|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics and baseline DLQI score.|Dermatology Life Quality Index (DLQI) = 0-1 at Week 12||4.58|1.65|< 0.001
74044228|NCT03051217|147639457|SUPERIORITY||Odds Ratio (OR)|38.696|||<|0.0001|TWO_SIDED|97.5|6.047|247.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||247.634|6.047|<0.0001
74014846|NCT05032157|147580564|SUPERIORITY||Rate ratio|3.26|||<|0.001|TWO_SIDED|95.0|2.26|4.71|||Regression, Linear||Negative binomial regression with log link includes treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics as covariates. A rate ratio \>1 favors LOU064 25 mg b.i.d.|Disease activity control (UAS7 =\< 6) up to Week 12||4.71|2.26|< 0.001
74044229|NCT03051217|147639457|SUPERIORITY||Odds Ratio (OR)|100.459|||<|0.0001|TWO_SIDED|97.5|15.54|649.437||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||649.437|15.540|<0.0001
74044230|NCT03051217|147639458|SUPERIORITY||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|TWO_SIDED|97.5|-9.1|-3.844||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.844|-9.100|<0.0001
74044231|NCT03051217|147639458|SUPERIORITY||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|TWO_SIDED|97.5|-9.099|-3.91||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.910|-9.099|<0.0001
74044232|NCT03051217|147639459|SUPERIORITY||Adjusted Mean Treatment Difference|-3.1|||<|0.0001|TWO_SIDED|95.0|-4.265|-2.002||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-2.002|-4.265|<0.0001
74044233|NCT03051217|147639459|SUPERIORITY||Adjusted Mean Treatment Difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.295|-3.069||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.069|-5.295|<0.0001
74044234|NCT00109772|147639466|SUPERIORITY_OR_OTHER|||||||0.894||95.0|||||Cochran-Mantel-Haenszel|controlled for centers||||||.8940
74044235|NCT03437044|147639483|SUPERIORITY|||||||0.001|||||||ANCOVA|the corresponding baseline value of platelet reactivity was used as covariate||||||0.001
74095129|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.06||||0.038|TWO_SIDED|95.0|-21.51|-0.61|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.61|-21.51|0.038
74044236|NCT03437044|147639484|SUPERIORITY||||||<|0.001|||||||ANCOVA|the corresponding baseline value of platelet reactivity was used as covariate||||||<0.001
74044237|NCT00282568|147639488|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|94.97|||||TWO_SIDED|90.0|90.72|99.41|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||99.41|90.72|
74014847|NCT05032157|147580565|SUPERIORITY||Rate ratio|1.32|||<|0.001|TWO_SIDED|95.0|1.17|1.49|||Regression, Linear||Negative binomial regression with log link included treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics, baseline AAS7 = 0 response as covariates. A rate ratio \> 1 favors LOU064 25 mg b.i.d.|Angioedema occurrence-free weeks (AAS7 = 0 response) up to Week 12||1.49|1.17|< 0.001
74095130|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-17.9||||0.013||95.0|-32.13|-3.79|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||-3.79|-32.13|0.013
74014848|NCT02164981|147580593|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.57|TWO_SIDED|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||Given the sequential parallel comparison design (SPCD), we used a two-stage test (weighted z-test, Tamura approach: CHANGE\_score = BASELINE\_value + GROUP (i.e., SNP vs. placebo)) to combine the data on treatment effects from phases 1 and 2 (weighted equally). Assessments were on Day -1 (phase 1 baseline), Day 13 (phase 1 outcome, phase 2 baseline) and Day 28 (phase 2 outcome). Only participants who at least started the infusion were included in analysis (i.e., modified intent to treat).||||0.57
74014849|NCT02164981|147580593|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.54|TWO_SIDED|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||The same analysis as in Analysis 1 was conducted, except that CLOZAPINE (i.e., patient used clozapine vs. other antipsychotic) was added as a covariate.||||0.54
74014850|NCT02164981|147580594|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.35|TWO_SIDED|||||Exploratory efficacy outcome, hence no adjustment for multiple comparison.|ANCOVA|||||||0.35
74014851|NCT02164981|147580594|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.37|TWO_SIDED|||||Exploratory efficacy outcome, hence no adjustment for multiple comparisons|ANCOVA|||||||0.37
74014852|NCT02164981|147580595|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.85|TWO_SIDED||||||ANCOVA|||||||0.85
74014853|NCT02164981|147580595|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.88|TWO_SIDED||||||ANCOVA|||||||0.88
74044238|NCT00282568|147639490|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.15|||||TWO_SIDED|90.0|82.69|93.96|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmax. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmax prior to analysis and the results were transformed back to the original scale for the presentation of results.||93.96|82.69|
74095131|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.85||||0.467||95.0|-14.23|6.53|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||6.53|-14.23|0.467
74095132|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.38||||0.049||95.0|-20.73|-0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.02|-20.73|0.049
74095133|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-14.1||||0.05||95.0|-28.22|0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.02|-28.22|0.050
74095134|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-7.99||||0.255||95.0|-21.73|5.76|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||5.76|-21.73|0.255
74014854|NCT02164981|147580596|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.86|TWO_SIDED||||||ANCOVA|||||||0.86
74014855|NCT02164981|147580596|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.83|TWO_SIDED||||||ANCOVA|||||||0.83
74014856|NCT02164981|147580602|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.33|TWO_SIDED||||||ANCOVA|||||||0.33
74014857|NCT02164981|147580602|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.34|TWO_SIDED||||||ANCOVA|||||||0.34
74014858|NCT02164981|147580605|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.34|TWO_SIDED||||||ANCOVA|||||||0.34
74014859|NCT02164981|147580605|SUPERIORITY||Mean Difference (Final Values)|2.05||||0.36|TWO_SIDED||||||ANCOVA|||||||0.36
74014860|NCT02404103|147580618|EQUIVALENCE|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction with two doses.||||||0.148|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.148
74014861|NCT02404103|147580618|EQUIVALENCE|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.74|||||||Mixed Models Analysis|||||||.740
74014862|NCT02404103|147580618|EQUIVALENCE|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||0.921|||||||Mixed Models Analysis|||||||.921
74014863|NCT02404103|147580619|EQUIVALENCE|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction.||||||0.872|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.872
74044239|NCT00282568|147639491|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|87.2|||||TWO_SIDED|90.0|82.72|91.93|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||91.93|82.72|
74044240|NCT00324272|147639543|SUPERIORITY_OR_OTHER|||||||0.704||95.0|||||t-test, 2 sided|||||||0.704
74095135|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.57||||0.212||95.0|-16.89|3.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.75|-16.89|0.212
74095136|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-15.68||||0.027||95.0|-29.59|-1.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||-1.77|-29.59|0.027
74095137|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-4.39||||0.399|TWO_SIDED|95.0|-14.59|5.82|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||5.82|-14.59|0.399
74095138|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-7.5||||0.152||95.0|-17.76|2.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.77|-17.76|0.152
74014864|NCT02404103|147580619|EQUIVALENCE|secondary goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.82|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||0.820
74014865|NCT02404103|147580619|EQUIVALENCE|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.582|||||||Mixed Models Analysis|||||||0.582
74014866|NCT02404103|147580620|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.782|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.782
74095139|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.32||||0.106|TWO_SIDED|95.0|-25.05|2.4|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.40|-25.05|0.106
74014867|NCT02404103|147580620|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.906|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.906
74014868|NCT02404103|147580620|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.102|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.102
74014869|NCT02404103|147580621|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.62|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.620
74014870|NCT02404103|147580621|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.543|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.543
74014871|NCT02404103|147580621|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.6|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.6
74044241|NCT00324272|147639543|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||t-test, 2 sided|||||||0.217
74095140|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.59||||0.21||95.0|-22.0|4.83|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||4.83|-22.00|0.210
74044242|NCT00324272|147639545|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||t-test, 2 sided|||||||0.988
74044243|NCT00324272|147639545|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||t-test, 2 sided|||||||0.426
74044244|NCT00324272|147639546|SUPERIORITY_OR_OTHER|||||||0.351||95.0|||||Fisher Exact|||||||0.351
74044245|NCT00324272|147639546|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher Exact|||||||0.480
74044246|NCT00324272|147639547|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
74044247|NCT00324272|147639547|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.400
74095141|NCT02912650|147740356|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.13||||0.545||95.0|-13.26|7.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||7.00|-13.26|0.545
74095142|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|20.74|||<|0.001|TWO_SIDED|95.0|10.54|30.94|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||30.94|10.54|<0.001
74014872|NCT00328627|147580635|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.67|-0.41||For the primary analysis, the overall average HbA1c response of the Alogliptin/pioglitazone combination groups was compared with that of the pioglitazone alone groups at the 2-sided 0.05 significance level with no adjustment for multiple comparisons.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||The null hypothesis was that the doses of alogliptin do not have any additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone. The alternative hypothesis was that at least the higher dose of alogliptin would have an additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone.||-0.41|-0.67|<0.001
74044248|NCT00324272|147639548|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Local recurrence in the groin cohort.||||1.00
74044249|NCT00324272|147639548|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||Fisher Exact|||In transit or regional recurrence in the groin cohort.||||0.301
74044250|NCT00324272|147639548|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Fisher Exact|||Distant metastasis in the groin cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).||||0.474
74044251|NCT00324272|147639548|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||Fisher Exact|||Local recurrence in the groin cohort.||||0.606
74044252|NCT00324272|147639548|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||In transit or regional recurrence in the axillary cohort.||||1.000
74044253|NCT00324272|147639548|SUPERIORITY_OR_OTHER|||||||0.486||95.0|||||Fisher Exact|||Distant metastasis in the axillary cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).||||0.486
74095143|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.52||||0.342|TWO_SIDED|95.0|-4.81|13.86|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.86|-4.81|0.342
74095144|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|3.62||||0.459|TWO_SIDED|95.0|-5.98|13.22|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.22|-5.98|0.459
74095145|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|16.2||||0.001|TWO_SIDED|95.0|6.24|26.17|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||26.17|6.24|0.001
74095146|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|17.37|||<|0.001|TWO_SIDED|95.0|7.42|27.31|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||27.31|7.42|<0.001
74095147|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.91||||0.849|TWO_SIDED|95.0|-10.2|8.42|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.42|-10.2|0.849
74044254|NCT00324272|147639549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.963|TWO_SIDED|95.0|0.4|2.58|||Regression, Cox|||Death from metastatic disease in the groin cohort.||2.58|0.40|0.963
74044255|NCT00324272|147639549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.338|TWO_SIDED|95.0|0.03|3.2|||Regression, Cox|||Death from an unrelated cause in the groin cohort.||3.20|0.03|0.338
74044256|NCT00324272|147639549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.88|TWO_SIDED|95.0|0.35|2.47|||Regression, Cox|||Death from metastatic disease in the axillary cohort.||2.47|0.35|0.880
74044257|NCT00324272|147639549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.923||||0.923|TWO_SIDED|95.0|0.05|13.95|||Regression, Cox|||Death from an unrelated cause in the axillary cohort.||13.95|0.05|0.923
74095148|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.08|||<|0.001|TWO_SIDED|95.0|39.53|62.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||62.62|39.53|<0.001
74044258|NCT01057862|147639553|OTHER|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|6.0|STANDARD_DEVIATION|9.35|||TWO_SIDED||||||||The active arm had a mean PG-YBOCS score of 16 (n=5) at study start with a SD of 7.35. At end of study the active arm had a mean PG-YBOCS score of 10 (n=5) with a SD of 9.35. The placebo arm is not included here as there were only two scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.||||
74095149|NCT02912650|147740357|SUPERIORITY_OR_OTHER||Cumulative Percentage of Participants wi|5.16||||0.318|TWO_SIDED|95.0|-4.97|15.3|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.30|-4.97|0.318
74095150|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.86||||0.062|TWO_SIDED|95.0|-0.49|20.21|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||20.21|-0.49|0.062
74095151|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|45.6|||<|0.001|TWO_SIDED|95.0|33.45|57.76|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.76|33.45|<0.001
74014873|NCT00328627|147580635|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|||<|0.001|TWO_SIDED|95.0|-0.66|-0.41|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.41|-0.66|<0.001
74014874|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-0.93|-0.48||As a supportive analysis, each of the individual combination treatment groups was compared with the component treatment groups receiving aloliptin alone and pioglitazone alone at the 2-sided 0.05 significance level with no multiplicity adjustment.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.48|-0.93|<0.001
74014875|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.81|-0.38|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.38|-0.81|<0.001
74014876|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.15|-0.59|0.001
74014877|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.30|-0.74|<0.001
74014878|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.53|-0.98|<0.001
74014879|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.25|-0.70|<0.001
74014880|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.27|-0.71|<0.001
74014881|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.25|-0.70|<0.001
74044259|NCT01057862|147639554|OTHER|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|9.45|||TWO_SIDED||||||||The active treatment arm had a mean G-SAS score of 26.8 (n=5) at study start with a SD of 11.73. At end the active treatment arm had a mean G-SAS score of 12.6 (n=5) with a SD of 9.45. The placebo arm is not included as there were only 2 scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.||||
74044260|NCT03434041|147639564|SUPERIORITY||Difference of Least Square (LS) Means|-2.0||||0.123|TWO_SIDED|95.0|-4.64|0.55||2-sided|Mixed-effects Model for Repeated Measure|||||0.55|-4.64|0.123
73880187|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|2.69||||0.4299|TWO_SIDED|95.0|0.23|31.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||31.21|0.23|0.4299
74014882|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.13|-0.68|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.68|-1.13|<0.001
74014883|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|||<|0.001|TWO_SIDED|95.0|-0.77|-0.33|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.33|-0.77|<0.001
74014884|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-0.92|-0.48|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.48|-0.92|<0.001
74014885|NCT00328627|147580667|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.83|-0.39|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.39|-0.83|<0.001
74014886|NCT02600507|147580795|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.03||0.021|TWO_SIDED|95.0|-4.42|-0.37|||Mixed Effects Model for Repeated Measure|||||-0.37|-4.42|0.021
74014887|NCT02600507|147580795|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.01||0.099|TWO_SIDED|95.0|-3.65|0.32|||Mixed Effects Model for Repeated Measure|||||0.32|-3.65|0.099
74014888|NCT02600507|147580796|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.008|TWO_SIDED|95.0|-0.59|-0.09|||Mixed Effects Model for Repeated Measure|||||-0.09|-0.59|0.008
74014889|NCT02600507|147580796|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.04|TWO_SIDED|95.0|-0.5|-0.01|||Mixed Effects Model for Repeated Measure|||||-0.01|-0.50|0.040
74044261|NCT03434041|147639565|SUPERIORITY||Difference of LS Means|-3.3|||||TWO_SIDED|95.0|-5.33|-1.33||||||||-1.33|-5.33|
74044262|NCT03434041|147639566|SUPERIORITY||Difference of LS Means|-1.0|||||TWO_SIDED|95.0|-2.96|0.97||||||||0.97|-2.96|
74044263|NCT00444080|147639620|OTHER|||||||0.013|||||||Fisher Exact|||||||0.013
74044264|NCT03363165|147639627|SUPERIORITY||Mean Difference (Final Values)|-13.54||||0.7586|ONE_SIDED|90.0|-38.52||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-38.52|0.7586
74014890|NCT00621504|147580822|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on each of the CE and the MITTE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for each of the CE and MITTE Populations.|Risk Difference (RD)|6.2|||||TWO_SIDED|95.0|-0.2|12.6|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE and MITTE Populations in adult subjects with CABP.||12.6|-0.2|
74014891|NCT03657368|147580852|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.042|TWO_SIDED|97.5|-0.4|7.3|||Regression, Linear|||||7.3|-0.4|0.042
74014892|NCT03657368|147580852|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.966|TWO_SIDED|97.5|-3.9|3.7|||Regression, Linear|||||3.7|-3.9|0.966
74014893|NCT03657368|147580853|SUPERIORITY||Odds Ratio (OR)|0.93||||0.519|TWO_SIDED|99.2|0.68|1.27|||Regression, Logistic|||||1.27|0.68|0.519
74014894|NCT03657368|147580853|SUPERIORITY||Odds Ratio (OR)|0.87||||0.232|TWO_SIDED|99.2|0.63|1.19|||Regression, Logistic|||||1.19|0.63|0.232
74014895|NCT03657368|147580854|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.217|TWO_SIDED|99.2|-6.5|2.4|||Regression, Linear|||||2.4|-6.5|0.217
74014896|NCT03657368|147580854|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.66|TWO_SIDED|99.2|-3.7|5.2|||Regression, Linear|||||5.2|-3.7|0.660
74014897|NCT03657368|147580855|SUPERIORITY||mean ratio|1.03||||0.143|TWO_SIDED|99.2|0.97|1.1|||Mixed Models Analysis|||||1.10|0.97|0.143
74014898|NCT03657368|147580855|SUPERIORITY||mean ratio|0.99||||0.649|TWO_SIDED|99.2|0.93|1.05|||Regression, Logistic|||||1.05|0.93|0.649
74044265|NCT03363165|147639628|SUPERIORITY||Mean Difference (Final Values)|2.25||||0.0298|ONE_SIDED|90.0|0.78||||ANCOVA|Adjusted for baseline maximal treadmill walking time, age, race, former smoker|||||0.78|0.0298
73888032|NCT01746901|147309531|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.1331|TWO_SIDED|95.0|-0.5|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|-0.5|0.1331
74014899|NCT01623271|147580858|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
74014900|NCT01137773|147580877|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
74014901|NCT01137773|147580878|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
74014902|NCT03548051|147580883|SUPERIORITY||Difference in Proportions|0.05|||>|0.999|TWO_SIDED|95.0|-0.58|0.65||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in proportions between study arms, with a two-sided alternative.||0.65|-0.58|>0.999
74014903|NCT03548051|147580886|SUPERIORITY||Difference in Proportions|0.05|||>|0.999|TWO_SIDED|95.0|-0.58|0.65||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in proportions between study arms, with a two-sided alternative.||0.65|-0.58|>0.999
74014904|NCT03548051|147580887|SUPERIORITY||||||>|0.999||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Log Rank|||A Log-Rank permutation test for small samples was used to test the null hypothesis that there is no difference in the time to first CDAD recurrence between treatment arms.||||>0.999
74014905|NCT01745146|147580888|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.047||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes reported at non-responders.||||0.047
74014906|NCT01745146|147580888|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.549||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes reported at non-responders.||||0.549
74014907|NCT01745146|147580888|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.511||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes reported at non-responders.||||0.511
74044266|NCT03363165|147639629|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.4019|ONE_SIDED|90.0|-3.1||||ANCOVA|Adjusted for baseline perfusion, age, race, former smoker.|||||-3.10|0.4019
74044267|NCT03363165|147639630|SUPERIORITY||Mean Difference (Final Values)|8.28||||0.208|ONE_SIDED|90.0|-5.37||||ANCOVA|Adjusted for baseline muscle measure, age, race, former smoker.|||||-5.37|0.2080
74044268|NCT03363165|147639631|SUPERIORITY||Mean Difference (Final Values)|2.02||||0.398|ONE_SIDED|90.0|-8.11||||ANCOVA|Adjusted for baseline WIQ distance score, age, race, former smoker|||||-8.11|0.3980
74044269|NCT03363165|147639632|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.7852|ONE_SIDED|90.0|-14.5||||ANCOVA|Adjusted for baseline SF-36 physical functioning score, age, race, former smoker.|||||-14.50|0.7852
74044270|NCT03363165|147639633|SUPERIORITY||Mean Difference (Final Values)|-5.14||||0.8414|ONE_SIDED|90.0|-11.76||||ANCOVA|Adjusted for baseline SF-36 physical functioning score, age, race, former smoker.|||||-11.76|0.8414
74044271|NCT03363165|147639634|SUPERIORITY||Mean Difference (Final Values)|-2.13||||0.5912|ONE_SIDED|90.0|-14.11||||ANCOVA|Adjusted for baseline WIQ distance score, age, race, former smoker.|||||-14.11|0.5912
73888033|NCT01746901|147309531|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.8732|TWO_SIDED|95.0|-2.1|2.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.4|-2.1|0.8732
74044272|NCT03363165|147639635|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.5442|ONE_SIDED|90.0|-25.47||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-25.47|0.5442
74044273|NCT03363165|147639636|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.6603|ONE_SIDED|90.0|-2.11|||Adjusted for baseline pain-free treadmill walking time, age, race, former smoker.|ANCOVA||||||-2.11|0.6603
74044274|NCT03363165|147639637|SUPERIORITY||Mean Difference (Final Values)|-2.78||||0.5647|ONE_SIDED|90.0|-24.99||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-24.99|0.5647
74044275|NCT01363258|147639680|OTHER|Generalized linear mixed models fitted with binomial (logit link) and gamma (log link) distributions, with additional dispersion parameters, were used to estimate and test intervention effects in terms of occurrence and intensity of CRBs, respectively. Inference was conducted in the link scale, but inverse-link estimates in the original scales (proportions and CRB scores, for the binomial and gamma models, respectively) were computed to facilitate interpretation.|Effect size|-0.16||||0.1433|TWO_SIDED||||||Time by group interaction test|||||||0.1433
74044276|NCT00583661|147639685|NON_INFERIORITY_OR_EQUIVALENCE|Sample size determination: A sample of 24 subjects followed for approximately 100 days provides greater than 80% power to conclude that, with a 1-sided alpha=0.025 test, the SAE rate of the EXCOR (assumed to be 0.21 per patient-day) is less than 0.25 per patient-day. This sample size was estimated using 10,000 simulations of this study. A total enrollment of 48 subjects (24 per cohort) were enrolled and implanted with the EXCOR® Pediatric.|Poisson confidence interval|0.25|||<|0.05|TWO_SIDED|95.0|0.0|0.25||A Poisson exact confidence interval was calculated and the critical-value method was used for the significance testing. Success was defined as the upper bound of the 95% Poisson exact confidence interval being less than 0.25.|Poisson confidence interval|||Ho: EXCOR® SAE Rate \>=0.25 Ha: EXCOR® SAE Rate \< 0.25 Where serious adverse event (SAE) rate is calculated as the total number of serious adverse events divided by the sum of days all patients are on the EXCOR® Pediatric device, and 0.25 serious adverse events per patient-day is the success criterion. Study success in terms of safety will be demonstrated by the upper bound of a two-sided 95% Poisson exact confidence interval being less than 0.25.||0.25|0|<0.05
74044277|NCT04010370|147639688|SUPERIORITY||||||<|0.001|||||||Spearman correlation|||Correlation of McAuley index with PREDIM index at baseline.||||<0.001
74044278|NCT04010370|147639689|SUPERIORITY|||||||0.319|||||||Spearman correlation|||Correlation of Belfiore index with PREDIM index at baseline.||||0.319
74044279|NCT04010370|147639690|SUPERIORITY|||||||0.27|||||||Spearman correlation|||Correlation of Cederholm index with PREDIM index at baseline.||||0.27
74044280|NCT04010370|147639691|SUPERIORITY|||||||0.246|||||||Spearman correlation|||Correlation of Avignon index with PREDIM index at baseline.||||0.246
74044281|NCT04010370|147639692|SUPERIORITY|||||||0.259|||||||Spearman correlation|||Correlation of Matsuda index with PREDIM index at baseline.||||0.259
74044282|NCT04010370|147639693|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of Gutt index with PREDIM index at baseline.||||0.69
74044283|NCT04010370|147639694|SUPERIORITY|||||||0.022|||||||Spearman correlation|||Correlation of Stumvoll index with PREDIM index at baseline.||||0.022
74044284|NCT04010370|147639695|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of HOMA-IR index with PREDIM index at baseline.||||0.69
74044285|NCT04010370|147639696|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of ISI index with PREDIM index at baseline.||||0.69
74044286|NCT04010370|147639697|SUPERIORITY|||||||0.541|||||||Spearman correlation|||Correlation of Raynaud index with PREDIM index at baseline.||||0.541
74044287|NCT04010370|147639698|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of QUICKI index with PREDIM index at baseline.||||0.69
74044288|NCT04010370|147639699|SUPERIORITY|||||||0.531|||||||Spearman correlation|||Correlation of FIRI index with PREDIM index at baseline.||||0.531
74044289|NCT04010370|147639700|SUPERIORITY|||||||0.726|||||||Spearman correlation|||Correlation of Bennett index with PREDIM index at baseline.||||0.726
74044290|NCT04010370|147639701|SUPERIORITY|||||||0.787|||||||Spearman correlation|||Correlation of TyG index with PREDIM index at baseline.||||0.787
74014908|NCT01745146|147580888|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.031||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes excluded for this analysis.||||0.031
74014909|NCT01745146|147580888|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.483||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes excluded for this analysis.||||0.483
74014910|NCT01745146|147580888|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.53||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes excluded for this analysis.||||0.530
74014911|NCT01745146|147580888|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.421||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes included as non-responders.||||0.421
74014912|NCT01745146|147580888|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.332||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes excluded for this analysis.||||0.332
74014913|NCT02684981|147580889|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in PACT-Q2 scores from V1 to V2||||< 0.0001
74014914|NCT02684981|147580889|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in convenience PACT-Q2 scores from V1 to V3||||< 0.0001
74014915|NCT02684981|147580890|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V2||||< 0.0001
74014916|NCT02684981|147580890|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V3||||< 0.0001
74044291|NCT02925312|147639702|SUPERIORITY|||||||0.05|||||||McNemar|||The study was powered to detect a difference of 0.5 in the change in HbA1c with SD=2 with 80% power at alpha=0.05 with a sample size of 128 in each group (paired t-test). Differences in patient characteristics and the unadjusted differences in the outcome measures between the intervention and control groups were tested using linear mixed models, McNemar tests and conditional logistic models due to matching.||||0.05
74044292|NCT01998399|147639733|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Chi-squared|||Total enrollment only 25 patients and the study was terminated early due to low enrollment. No further statistical analysis was done.||||0.41
73888034|NCT01746901|147309532|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.4555|TWO_SIDED|95.0|-5.9|13.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.2|-5.9|0.4555
74014917|NCT02684981|147580891|OTHER||Mean Difference (Net)|18.377|STANDARD_ERROR_OF_MEAN|0.514|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)||||< 0.001
74014918|NCT02684981|147580891|OTHER||Mean Difference (Net)|23.341|STANDARD_ERROR_OF_MEAN|0.509|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)||||< 0.001
74014919|NCT02684981|147580892|OTHER||Mean Difference (Net)|15.884|STANDARD_ERROR_OF_MEAN|0.388|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)||||< 0.001
74044293|NCT00418717|147639758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||||95.0|-0.25|0.06||||||||0.06|-0.25|
74044294|NCT01142193|147639762|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
74044295|NCT01142193|147639762|SUPERIORITY_OR_OTHER||Median Difference (Net)|18.5|||||TWO_SIDED|95.0|8.53|28.1|||Hodges-Lehmann|||||28.1|8.53|
74044296|NCT01142193|147639763|SUPERIORITY_OR_OTHER||Difference in Percentages|14.7||||0.013|||||||Fisher Exact|||||||0.013
74044297|NCT01142193|147639764|SUPERIORITY_OR_OTHER||Difference in Percentages|16.3||||0.007|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.||||||0.007
74014920|NCT02684981|147580892|OTHER||Mean Difference (Net)|19.011|STANDARD_ERROR_OF_MEAN|0.408|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)||||< 0.001
74014921|NCT02684981|147580900|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Median convenience and satisfaction PACT-Q2 scores at last assessment compared to second assessment||||< 0.001
74014922|NCT03605680|147580916|SUPERIORITY||Least Squares (LS ) Mean Difference|-3.15|||=|0.0193|TWO_SIDED|95.0|-5.79|-0.51|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.51|-5.79|=0.0193
74014923|NCT03605680|147580916|SUPERIORITY||LS Mean Difference|-2.74|||=|0.0392|TWO_SIDED|95.0|-5.35|-0.14|||MMRM|||||-0.14|-5.35|=0.0392
74014924|NCT03605680|147580917|SUPERIORITY||LS Mean Difference|-0.27|||=|0.0232|TWO_SIDED|95.0|-0.5|-0.04|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.04|-0.50|=0.0232
74014925|NCT03605680|147580917|SUPERIORITY||LS Mean Difference|-0.28|||=|0.0162|TWO_SIDED|95.0|-0.51|-0.05|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.05|-0.51|=0.0162
74044298|NCT01142193|147639765|SUPERIORITY_OR_OTHER||Median Difference (Net)|25.36|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74044299|NCT01142193|147639766|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74044300|NCT01142193|147639770|SUPERIORITY_OR_OTHER||Median Difference (Net)|23.61||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74095152|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|41.07|||<|0.001|TWO_SIDED|95.0|28.76|53.38|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||53.38|28.76|<0.001
74014926|NCT01789814|147580940|SUPERIORITY_OR_OTHER|||||||0.001||||||Prasugrel treatment when compared to Clopidogrel was associated with significant reduction in platelets aggregation for all plateles agonist (ADD, SFFFLRN, AYPGKF) at all measured time points.|t-test, 2 sided|||Each patient will have paired samples representing their baseline as well as an on-drug sample. The magnitude of platelet inhibition for each studied agonist will be performed utilizing mean maximal change from baseline in light transmission aggregometry. The paired samples will be analyzed using a two-tailed student's t-test. Statistical significance will be assumed to occur when p\<0.05.||||0.001
74014927|NCT01425203|147580990|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|29.2|||<|0.0001|TWO_SIDED|95.0|16.4|41.5||Multiplicity adjustment for controlling type 1 error for the primary comparison was based on the step-down approach.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The primary statistical comparison was conducted on the FAS using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors, including IL28B genotype and previous treatment as specified at the time of randomization.||41.5|16.4|<0.0001
74014928|NCT01425203|147580991|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|30.2|||<|0.0001|TWO_SIDED|95.0|17.3|42.5||Multiplicity adjustment for controlling type 1 error for key secondary comparison based on a step-down approach. Key-secondary comparison was tested only if statistical significance of primary comparison was met at alpha level of 0.050.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The key secondary statistical comparison was conducted on the mITT using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors.||42.5|17.3|<0.0001
74014929|NCT01425203|147580992|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|45.6|||<|0.0001|TWO_SIDED|95.0|33.2|57.0|||Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The percentage of participants achieving EVR at TW8 was compared using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors in the FAS population.||57.0|33.2|<0.0001
74044301|NCT01142193|147639771|SUPERIORITY_OR_OTHER||Difference in Percentages|13.4||||0.048|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.||||||0.048
74044302|NCT01203787|147639784|SUPERIORITY_OR_OTHER|||||||0.0262|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.0262
74044303|NCT01041404|147639810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Log Rank|||||0.85|0.59|0.0002
74044304|NCT01041404|147639812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.0|0.58|0.85|||Log Rank|||||0.85|0.58|0.0003
74044305|NCT01041404|147639813|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.8||||0.0017|TWO_SIDED|95.0|4.7|20.9|||Chi-squared|||||20.9|4.7|0.0017
74044306|NCT01041404|147639815|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.73|||Log Rank|||||0.73|0.40|<0.0001
74044307|NCT01041404|147639816|SUPERIORITY_OR_OTHER||Difference in Clinical Benefit Rate|9.6||||0.0081|TWO_SIDED|95.0|2.4|16.9|||Chi-squared|||||16.9|2.4|0.0081
74044308|NCT01041404|147639816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66|||||TWO_SIDED|95.0|1.14|2.41||||||||2.41|1.14|
74044309|NCT01041404|147639817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0046|TWO_SIDED|95.0|0.6|0.91|||Log Rank|||||0.91|0.60|0.0046
74044310|NCT03627494|147639878|OTHER||Ratio|0.93|||||TWO_SIDED|90.0|0.84|1.03|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.03|0.84|
74095153|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.74||||0.374|TWO_SIDED|95.0|-5.7|15.17|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.17|-5.70|0.374
74095154|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.09|||<|0.001|TWO_SIDED|95.0|47.93|72.26|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.26|47.93|<0.001
74095155|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.3||||0.323|TWO_SIDED|95.0|-4.22|12.81|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||12.81|-4.22|0.323
74095156|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.86||||0.032|TWO_SIDED|95.0|0.86|18.86|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.86|0.86|0.032
74095157|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|55.66|||<|0.001|TWO_SIDED|95.0|43.11|68.2|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||68.20|43.11|<0.001
74095158|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.38|||<|0.001|TWO_SIDED|95.0|37.71|63.05|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||63.05|37.71|<0.001
74095159|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.61||||0.232|TWO_SIDED|95.0|-3.58|14.8|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.80|-3.58|0.232
74095160|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|59.92|||<|0.001|TWO_SIDED|95.0|47.39|72.46|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.46|47.39|<0.001
74095161|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.51||||0.179|TWO_SIDED|95.0|-2.52|13.53|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.53|-2.52|0.179
74095162|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.37||||0.003|TWO_SIDED|95.0|4.65|22.1|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.10|4.65|0.003
74095163|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|54.32|||<|0.001|TWO_SIDED|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||67.29|41.36|<0.001
74095164|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.99|33.50|<0.001
74095165|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74095166|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.51|||<|0.001|TWO_SIDED|95.0|47.99|73.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||73.03|47.99|<0.001
74095167|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.08||||0.135|TWO_SIDED|95.0|-1.89|14.05|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.89|0.135
74095168|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.97||||0.002|TWO_SIDED|95.0|5.3|22.64|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.64|5.30|0.002
74095169|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|54.32|||<|0.001|TWO_SIDED|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||67.29|41.36|<0.001
74095170|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.99|33.50|<0.001
74095171|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74095172|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
74095173|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
74095174|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
74095175|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74095176|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74014930|NCT00535132|147580997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|1.4|<|0.001||||||p-value based on a paired t-test for a within-group comparison.|t-test, 2 sided|||Sample size for this study was based on changes in the MSQ scores within subjects from baseline to endpoint using a one-sample paired t-test. A sample size of 97 subjects was shown to have 90% power at endpoint to detect a mean change from baseline of 0.5 units on the MSQ score, with a standard deviation of 1.5. Allowing for extra variability from subjects with prior generic risperidone (instead of branded risperidone) use, this number was increased to 150 subjects.||||<0.001
74014931|NCT00535132|147580998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|1.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
74014932|NCT00535132|147580999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|1.4|<|0.001|||||||t-test, 2 sided|||||||<0.001
74014933|NCT00535132|147581000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|1.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
74095177|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74095178|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
74095179|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
74095180|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
74095181|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74014934|NCT00535132|147581001|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.002
74014935|NCT00535132|147581002|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.033
74014936|NCT00535132|147581003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9|STANDARD_DEVIATION|13.1|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
74014937|NCT00535132|147581004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|0.9|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
74014938|NCT00535132|147581005|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.|Fisher Exact|||||||0.123
74014939|NCT00535132|147581006|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.125
74014940|NCT00535132|147581007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.3|STANDARD_DEVIATION|23.1|<|0.001||||||p-value for within-group comparison based on a paired t-test.|t-test, 2 sided|||||||<0.001
74014941|NCT00535132|147581008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|7.5||0.009|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||0.009
74014942|NCT00535132|147581009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_DEVIATION|10.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
74014943|NCT00535132|147581010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|4.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
74014944|NCT00535132|147581011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|3.0|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
74014945|NCT00267748|147581014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.089||||0.86|TWO_SIDED|95.0|0.423|2.803|||Log Rank|||For High risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.803|0.423|0.860
74014946|NCT00267748|147581014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.583|TWO_SIDED|95.0|0.623|1.306|||Log Rank|||For intermediate risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.306|0.623|0.583
74014947|NCT00267748|147581014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.556||||0.075|TWO_SIDED|95.0|0.288|1.074|||Log Rank|||For low risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.074|0.288|0.075
74014948|NCT00267748|147581014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.827||||0.22|TWO_SIDED|95.0|0.609|1.124|||Log Rank|||For overall stratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.124|0.609|0.220
74014949|NCT00267748|147581014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.773||||0.09|TWO_SIDED|95.0|0.572|1.044|||Log Rank|||For overall unstratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model. Two-sided unstratified Log rank method was used to calculate p value.||1.044|0.572|0.090
74044311|NCT03627494|147639879|OTHER||Ratio|0.93|||||TWO_SIDED|90.0|0.84|1.04|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.04|0.84|
73880188|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|4.87||||0.1667|TWO_SIDED|95.0|0.52|45.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||45.84|0.52|0.1667
74014950|NCT00267748|147581015|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.11||||0.444|TWO_SIDED|95.0|-6.4|14.6|||Chi-squared|||Response rate was estimated for each treatment group, 95% Confidence Interval (CI) on the difference in response rate between the 2 treatments was computed. P-value was calculated from a Pearson chi-square test.||14.6|-6.4|0.444
74014951|NCT00267748|147581017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.071||||0.866|TWO_SIDED|95.0|0.481|2.387|||Log Rank|||For high risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.387|0.481|0.866
74014952|NCT00267748|147581017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.169||||0.439|TWO_SIDED|95.0|0.785|1.741|||Log Rank|||For intermediate risk factor,the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.741|0.785|0.439
74014953|NCT00267748|147581017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.238||||0.614|TWO_SIDED|95.0|0.538|2.851|||Log Rank|||For low risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.851|0.538|0.614
74014954|NCT00267748|147581017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.365|TWO_SIDED|95.0|0.838|1.612|||Log Rank|||For overall stratified analysis, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.612|0.838|0.365
74014955|NCT00267748|147581018|SUPERIORITY_OR_OTHER|||||||0.6737|TWO_SIDED||||||t-test, 2 sided|||P value was calculated using sample t-test.||||0.6737
74014956|NCT00267748|147581019|SUPERIORITY_OR_OTHER|||||||0.1967|TWO_SIDED||||||t-test, 2 sided|||P value was calculated using sample t-test.||||0.1967
74014957|NCT01294800|147581020|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.7||||0.0564|TWO_SIDED|95.0|-1.37|0.02|||Constrained longitudinal data analysis|||||0.02|-1.37|0.0564
74014958|NCT01294800|147581020|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.5||||0.1844|TWO_SIDED|95.0|-1.16|0.22|||Constrained longitudinal data analysis|||||0.22|-1.16|0.1844
74014959|NCT01294800|147581020|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.3||||0.3386|TWO_SIDED|95.0|-1.04|0.36|||Constrained longitudinal data analysis|||||0.36|-1.04|0.3386
74044312|NCT03627494|147639880|OTHER||Ratio|0.89|||||TWO_SIDED|90.0|0.79|1.01|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.01|0.79|
74044313|NCT00671970|147639949|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
74044314|NCT00671970|147639950|SUPERIORITY_OR_OTHER|||||||0.613||95.0|||||Fisher Exact|||||||.613
74044315|NCT00671970|147639951|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
74044316|NCT00671970|147639952|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
74044317|NCT00671970|147639953|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
74044318|NCT00671970|147639954|SUPERIORITY_OR_OTHER|||||||0.179||95.0|||||Wilcoxon (Mann-Whitney)|||||||.179
74095182|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74095183|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74095184|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
74095185|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
74095186|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
74095187|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74095188|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74095189|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
73880189|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|8.11||||0.0592|TWO_SIDED|95.0|0.92|71.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||71.35|0.92|0.0592
74044319|NCT00671970|147639955|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||||||.008
73888035|NCT01746901|147309532|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.1495|TWO_SIDED|95.0|-2.5|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|-2.5|0.1495
74044320|NCT02741310|147639956|OTHER|The clinical hypothesis was that there would be no clinically meaningful difference between the blood pressure effects of sumatriptan alone and the effects of a single dose of erenumab IV and sumatriptan concomitant therapy. A clinically meaningful difference was defined as the upper bound of the 90% confidence interval (CI) of treatment difference between erenumab IV and sumatriptan compared to sumatriptan alone being ≥ 5 mmHg on the time-weighted scale resting MAP.|LS Mean Difference|-0.04|||||TWO_SIDED|90.0|-2.16|2.08||||||A linear mixed effects regression analysis was performed to assess if the time-weighted average in MAP for erenumab with sumatriptan is similar to sumatriptan alone. A two-sided 90% confidence interval (equivalent to a one-sided upper 95% CI) for the mean treatment difference was calculated using a linear mixed-effects model with fixed effects for treatment and period and a random effect for subject.||2.08|-2.16|
74044321|NCT02741310|147639958|OTHER||Geometric Least Squares Mean Ratio|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.03|0.93|
74044322|NCT02741310|147639959|OTHER||Geometric Least Squares Mean Ratio|1.0|||||TWO_SIDED|90.0|0.96|1.05||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.05|0.96|
73880190|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|18.28||||0.007|TWO_SIDED|95.0|2.21|151.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||151.2|2.21|0.0070
73880191|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.79||||0.2594|TWO_SIDED|95.0|0.37|38.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||38.32|0.37|0.2594
73880192|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|8.14||||0.0589|TWO_SIDED|95.0|0.92|71.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||71.67|0.92|0.0589
73880193|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|10.08||||0.0338|TWO_SIDED|95.0|1.19|85.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||85.20|1.19|0.0338
73880194|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7756|TWO_SIDED|95.0|0.12|4.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.88|0.12|0.7756
74044323|NCT02741310|147639960|OTHER||Geometric Least Squares Mean Ratio|0.95|||||TWO_SIDED|90.0|0.82|1.09||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.09|0.82|
74044324|NCT03417505|147639981|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|Paired t-test comparison||||||<0.01
74044325|NCT03417505|147639982|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparisons, one-sided||||||<0.05
73880195|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9246|TWO_SIDED|95.0|0.2|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.74|0.20|0.9246
74044326|NCT03417505|147639983|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|paired 1-sided t-test||||||<0.01
74044327|NCT03417505|147639984|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparison, one sided p value||||||<0.01
74044328|NCT03417505|147639985|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05.|t-test, 1 sided|paired||||||>0.05
74044329|NCT03417505|147639986|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.05
74044330|NCT03417505|147639987|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.01
74044331|NCT03417505|147639988|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.05
74044332|NCT03417505|147639989|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||>0.05
74044333|NCT00443846|147640003|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 95% confidence interval of the difference (Group 1 - Group 2) in seroprotection rate was greater than -10%.|Difference (Group 1 - Group 2)|0.0|||||TWO_SIDED|95.0|-3.7|3.7||||||Analysis of non-inferiority was based on the Miettinen and Nurminen method||3.7|-3.7|
74044334|NCT04583969|147640005|SUPERIORITY||Odds Ratio (OR)|1.13||||0.691|TWO_SIDED|95.0|0.63|2.02|||Regression, Logistic||Odds ratio above 1 favors Remdesivir plus Lenzilumab.|Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.||2.02|0.63|0.691
74044335|NCT04583969|147640006|SUPERIORITY||Odds Ratio (OR)|1.24||||0.378|TWO_SIDED|95.0|0.77|1.99|||Regression, Logistic||Odds ratio above 1 favors Remdesivir plus Lenzilumab.|Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.||1.99|0.77|0.378
74044336|NCT04583969|147640007|SUPERIORITY|Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline CRP.|Hazard Ratio, log|0.96||||0.689|TWO_SIDED|95.0|0.76|1.2|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab.|||1.20|0.76|0.689
74044337|NCT04583969|147640008|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.718|TWO_SIDED|95.0|0.79|1.18|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab.|Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal Score, age, and baseline CRP.||1.18|0.79|0.718
74044338|NCT04583969|147640009|SUPERIORITY||Odds Ratio (OR)|1.02||||0.907|TWO_SIDED|95.0|0.75|1.39|||Proportional odds model||Odds ratio greater than 1 favors Remdesivir plus Lenzilumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2.||1.39|0.75|0.907
74044339|NCT04583969|147640043|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.609|TWO_SIDED|95.0|0.87|1.27|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab|||1.27|0.87|0.609
74044340|NCT04583969|147640044|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.708|TWO_SIDED|95.0|0.85|1.26|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab|||1.26|0.85|0.708
74044341|NCT02420990|147640079|SUPERIORITY||Slope|-0.31|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
74044342|NCT02420990|147640079|SUPERIORITY||Slope|-0.67|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
74044343|NCT02420990|147640079|SUPERIORITY||Slope|0.05||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
74095190|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
74095191|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
74095192|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
74095193|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74095194|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74044344|NCT02420990|147640079|SUPERIORITY||Slope|0.56||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
74044345|NCT02420990|147640079|SUPERIORITY||Slope|-0.72||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
74044346|NCT02420990|147640080|SUPERIORITY||Slope|-1.78|||||TWO_SIDED||||||Linear Growth Curve Modeling|||||||
74044347|NCT02420990|147640080|SUPERIORITY||Slope|-0.64|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
74044348|NCT02420990|147640080|SUPERIORITY||Slope|0.07|||||TWO_SIDED||||||Linear Growth Curve Modeling|||||||
74044349|NCT02420990|147640080|SUPERIORITY||Slope|0.0|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
74044350|NCT02420990|147640080|SUPERIORITY||Slope|-1.44|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
74044351|NCT02420990|147640081|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.56|TWO_SIDED||||||Regression, Linear|||||||.56
74044352|NCT01525667|147640089|SUPERIORITY_OR_OTHER||Least Square Means (LSM) Difference|25.74|STANDARD_ERROR_OF_MEAN|8.94||0.0067|TWO_SIDED|95.0|7.61|43.86|||Mixed Models Analysis||LSM difference =LSM Low dose - LSM Placebo|||43.86|7.61|0.0067
74044353|NCT01525667|147640089|SUPERIORITY_OR_OTHER||Least Square Means (LSM) difference|14.93|STANDARD_ERROR_OF_MEAN|10.8||0.18|TWO_SIDED|95.0|-7.12|36.99|||Mixed Models Analysis||LSM difference= LSM High Dose - LSM Placebo|||36.99|-7.12|0.18
74044354|NCT01525667|147640090|SUPERIORITY_OR_OTHER||LSM Difference|18.03|STANDARD_ERROR_OF_MEAN|5.97||0.004|TWO_SIDED|95.0|6.03|30.02|||Mixed Models Analysis|||||30.02|6.03|0.004
74044355|NCT01525667|147640090|SUPERIORITY_OR_OTHER||LSM difference|9.23|STANDARD_ERROR_OF_MEAN|6.91||0.19|TWO_SIDED|95.0|-4.72|23.17|||Mixed Models Analysis|||||23.17|-4.72|0.19
74044356|NCT01525667|147640091|SUPERIORITY_OR_OTHER||LSM Difference|6.45|STANDARD_ERROR_OF_MEAN|4.64||0.19|TWO_SIDED|95.0|-3.5|16.41|||ANCOVA|||||16.41|-3.50|0.19
74044357|NCT01525667|147640091|SUPERIORITY_OR_OTHER||LSM difference|5.49|STANDARD_ERROR_OF_MEAN|4.56||0.25|TWO_SIDED|95.0|-4.29|15.26|||ANCOVA|||||15.26|-4.29|0.25
74044358|NCT01525667|147640092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.19||0.4|TWO_SIDED|95.0|-0.21|0.53|||Mixed Models Analysis|||||0.53|-0.21|0.4
74044359|NCT01525667|147640092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.011|STANDARD_ERROR_OF_MEAN|0.2||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||0.96
74044360|NCT01525667|147640093|SUPERIORITY_OR_OTHER||LSM difference|16.81|STANDARD_ERROR_OF_MEAN|8.37||0.05|TWO_SIDED|95.0|0.16|33.47|||Mixed Models Analysis|||||33.47|0.16|0.05
74044361|NCT01525667|147640093|SUPERIORITY_OR_OTHER||LSM difference|10.7|STANDARD_ERROR_OF_MEAN|9.01||0.24|TWO_SIDED|95.0|-7.26|28.65|||Mixed Models Analysis|||||28.65|-7.26|0.24
74044362|NCT01484561|147640099|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.92|||||TWO_SIDED|90.0|0.86|0.98|||ANCOVA||Analysis of covariance (ANCOVA) with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold Change (CP-690,550-placebo vs. placebo-placebo)||0.98|0.86|
74044363|NCT01484561|147640100|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|0.97|1.11|||ANCOVA||ANCOVA with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.11|0.97|
74044364|NCT01484561|147640101|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.09|||||TWO_SIDED|90.0|1.02|1.16|||ANCOVA||ANCOVA with change in logarithmic mGFR from Period 2 baseline/the end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.16|1.02|
74044365|NCT01484561|147640102|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.94|||||TWO_SIDED|90.0|0.91|0.97|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||0.97|0.91|
74044366|NCT01484561|147640103|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||TWO_SIDED|90.0|0.96|1.02|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.02|0.96|
74044367|NCT01484561|147640104|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|1.0|1.08|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.08|1.00|
74095195|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74014960|NCT01294800|147581021|SUPERIORITY_OR_OTHER||Difference in proportions of responders|5.7||||0.404|TWO_SIDED|95.0|-7.75|19.0|||A generalized linear mixed model|||||19.00|-7.75|0.404
74095196|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
74095197|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
74014961|NCT01294800|147581021|SUPERIORITY_OR_OTHER||Difference in proportions of responders|5.7||||0.39|TWO_SIDED|95.0|-7.73|18.81|||A generalized linear mixed model|||||18.81|-7.73|0.390
74014962|NCT01294800|147581021|SUPERIORITY_OR_OTHER||Difference in proportions of responders|-4.9||||0.508|TWO_SIDED|95.0|-17.78|7.97|||A generalized linear mixed model|||||7.97|-17.78|0.508
74014963|NCT01294800|147581022|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.7||||0.0509|TWO_SIDED|95.0|0.0|1.43|||Constrained longitudinal data analysis|||||1.43|-0.00|0.0509
74014964|NCT01294800|147581022|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.5||||0.1847|TWO_SIDED|95.0|-0.23|1.19|||Constrained longitudinal data analysis|||||1.19|-0.23|0.1847
74014965|NCT01294800|147581022|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.5||||0.2021|TWO_SIDED|95.0|-0.25|1.19|||Constrained longitudinal data analysis|||||1.19|-0.25|0.2021
74014966|NCT01857713|147581025|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.|||||<|0.05|||||||t-test, 1 sided|||The sample size was based on the primary effectiveness variable (% reduction in RSI from Baseline to Week 4). It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.||||<0.05
74014967|NCT03594227|147581037|SUPERIORITY||Mean Difference (Net)|-19.26|STANDARD_ERROR_OF_MEAN|5.02||0.011|TWO_SIDED|95.0|-33.98|-4.54||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-4.54|-33.98|0.011
74014968|NCT03594227|147581037|SUPERIORITY||Mean Difference (Final Values)|-24.08|STANDARD_ERROR_OF_MEAN|5.02||0.001|TWO_SIDED|95.0|-38.8|-9.36||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-9.36|-38.80|0.001
74014969|NCT03594227|147581037|SUPERIORITY||Mean Difference (Final Values)|-19.54|STANDARD_ERROR_OF_MEAN|5.133||0.01|TWO_SIDED|95.0|-34.41|-4.67||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-4.67|-34.41|0.010
74014970|NCT03594227|147581038|SUPERIORITY||Mean Difference (Final Values)|-19.17|STANDARD_ERROR_OF_MEAN|5.165||0.013|TWO_SIDED|95.0|-34.33|-4.02|||Mixed Models Analysis|||||-4.02|-34.33|0.013
74014971|NCT03594227|147581038|SUPERIORITY||Mean Difference (Net)|-24.53|STANDARD_ERROR_OF_MEAN|5.165||0.002|TWO_SIDED|95.0|-39.69|-9.38|||Mixed Models Analysis|||||-9.38|-39.69|0.002
74014972|NCT03594227|147581038|SUPERIORITY||Mean Difference (Net)|-19.17|STANDARD_ERROR_OF_MEAN|5.281||0.014|TWO_SIDED|95.0|-34.48|-3.86|||Mixed Models Analysis|||||-3.86|-34.48|0.014
74014973|NCT03594227|147581039|SUPERIORITY||Mean Difference (Net)|-11.29|STANDARD_ERROR_OF_MEAN|3.359||0.025|TWO_SIDED|95.0|-21.14|-1.45|||Mixed Models Analysis|||||-1.45|-21.14|0.025
74014974|NCT03594227|147581039|SUPERIORITY||Mean Difference (Net)|-15.25|STANDARD_ERROR_OF_MEAN|3.359||0.003|TWO_SIDED|95.0|-25.1|-5.4|||Mixed Models Analysis|||||-5.40|-25.10|0.003
74014975|NCT03594227|147581039|SUPERIORITY||Mean Difference (Net)|-17.55|STANDARD_ERROR_OF_MEAN|3.434|<|0.001|TWO_SIDED|95.0|-27.49|-7.6|||Mixed Models Analysis|||||-7.60|-27.49|<0.001
74014976|NCT03594227|147581040|SUPERIORITY||Mean Difference (Net)|-14.4|STANDARD_ERROR_OF_MEAN|3.599||0.008|TWO_SIDED|95.0|-24.95|-3.84|||Mixed Models Analysis|||||-3.84|-24.95|0.008
74014977|NCT03594227|147581040|SUPERIORITY||Mean Difference (Net)|-19.01|STANDARD_ERROR_OF_MEAN|3.599|<|0.001|TWO_SIDED|95.0|-29.56|-8.45|||Mixed Models Analysis|||||-8.45|-29.56|<0.001
74014978|NCT03594227|147581040|SUPERIORITY||Mean Difference (Net)|-17.52|STANDARD_ERROR_OF_MEAN|3.679||0.001|TWO_SIDED|95.0|-28.18|-6.86|||Mixed Models Analysis|||||-6.86|-28.18|0.001
74014979|NCT03594227|147581041|SUPERIORITY||Odds Ratio (OR)|4.6||||0.124|TWO_SIDED|95.0|0.7|31.8|||Mixed Models Analysis|||||31.8|0.7|0.124
74014980|NCT03594227|147581041|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.079|TWO_SIDED|95.0|0.8|38.3|||Mixed Models Analysis|||||38.3|0.8|0.079
74014981|NCT03594227|147581041|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.177|TWO_SIDED|95.0|0.5|27.7|||Mixed Models Analysis|||||27.7|0.5|0.177
74014982|NCT03594227|147581042|SUPERIORITY||Odds Ratio (OR)|4.6||||0.124|TWO_SIDED|95.0|0.7|31.8|||Mixed Models Analysis|||||31.8|0.7|0.124
74095198|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
74014983|NCT03594227|147581042|SUPERIORITY||Odds Ratio (OR)|5.6||||0.079|TWO_SIDED|95.0|0.8|38.3|||Mixed Models Analysis|||||38.3|0.8|0.079
74014984|NCT03594227|147581042|SUPERIORITY||Odds Ratio (OR)|3.9||||0.177|TWO_SIDED|95.0|0.5|27.7|||Mixed Models Analysis|||||27.7|0.5|0.177
74014985|NCT03594227|147581043|SUPERIORITY|||||||0.471|||||||Wilcoxon (Mann-Whitney)|||||||0.471
74014986|NCT03594227|147581043|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
74014987|NCT03594227|147581043|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|||||||0.367
74014988|NCT03594227|147581044|SUPERIORITY|||||||0.187|||||||Wilcoxon (Mann-Whitney)|||||||0.187
74014989|NCT03594227|147581044|SUPERIORITY|||||||0.375|||||||Wilcoxon (Mann-Whitney)|||||||0.375
74014990|NCT03594227|147581044|SUPERIORITY|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||||||0.581
74014991|NCT03594227|147581045|SUPERIORITY|||||||0.444|||||||Wilcoxon (Mann-Whitney)|||||||0.444
74014992|NCT03594227|147581045|SUPERIORITY|||||||0.861|||||||Wilcoxon (Mann-Whitney)|||||||0.861
74014993|NCT03594227|147581045|SUPERIORITY|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
74014994|NCT03594227|147581046|SUPERIORITY|||||||0.258|||||||Wilcoxon (Mann-Whitney)|||||||0.258
74014995|NCT03594227|147581046|SUPERIORITY|||||||0.263|||||||Wilcoxon (Mann-Whitney)|||||||0.263
74014996|NCT03594227|147581046|SUPERIORITY|||||||0.101|||||||Wilcoxon (Mann-Whitney)|||||||0.101
74014997|NCT03594227|147581047|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
74014998|NCT03594227|147581047|SUPERIORITY|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||||||0.277
74014999|NCT03594227|147581047|SUPERIORITY|||||||0.159|||||||Wilcoxon (Mann-Whitney)|||||||0.159
74015000|NCT03594227|147581048|SUPERIORITY|||||||0.407|||||||Wilcoxon (Mann-Whitney)|||||||0.407
74015001|NCT03594227|147581048|SUPERIORITY|||||||0.894|||||||Wilcoxon (Mann-Whitney)|||||||0.894
74015002|NCT03594227|147581048|SUPERIORITY|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||||||0.179
74015003|NCT03594227|147581049|SUPERIORITY|||||||0.691|||||||Wilcoxon (Mann-Whitney)|||||||0.691
74015004|NCT03594227|147581049|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
74015005|NCT03594227|147581049|SUPERIORITY|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||||||0.262
74015006|NCT03594227|147581050|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
74015007|NCT03594227|147581050|SUPERIORITY|||||||0.154|||||||Wilcoxon (Mann-Whitney)|||||||0.154
74015008|NCT03594227|147581050|SUPERIORITY|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||||||0.289
74015009|NCT03594227|147581051|SUPERIORITY|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||||||0.073
74015010|NCT03594227|147581051|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.660
74015011|NCT03594227|147581051|SUPERIORITY|||||||0.704|||||||Wilcoxon (Mann-Whitney)|||||||0.704
74015012|NCT03594227|147581052|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
74015013|NCT03594227|147581052|SUPERIORITY|||||||0.911|||||||Wilcoxon (Mann-Whitney)|||||||0.911
74015014|NCT03594227|147581052|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.110
74015015|NCT03594227|147581053|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.430
74015016|NCT03594227|147581053|SUPERIORITY|||||||0.288|||||||Wilcoxon (Mann-Whitney)|||||||0.288
74015017|NCT03594227|147581053|SUPERIORITY|||||||0.582|||||||Wilcoxon (Mann-Whitney)|||||||0.582
74015018|NCT03594227|147581054|SUPERIORITY|||||||0.194|||||||Wilcoxon (Mann-Whitney)|||||||0.194
74015019|NCT03594227|147581054|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
74015020|NCT03594227|147581054|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
74015021|NCT03594227|147581055|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||||||0.248
74015022|NCT03594227|147581055|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.150
74015023|NCT03594227|147581055|SUPERIORITY|||||||0.546|||||||Wilcoxon (Mann-Whitney)|||||||0.546
74015024|NCT03594227|147581056|SUPERIORITY|||||||0.341|||||||Wilcoxon (Mann-Whitney)|||||||0.341
74015025|NCT03594227|147581056|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
74015026|NCT03594227|147581056|SUPERIORITY|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||||||0.068
74015027|NCT03594227|147581058|SUPERIORITY|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||||||0.098
74015028|NCT03594227|147581058|SUPERIORITY|||||||0.082|||||||Wilcoxon (Mann-Whitney)|||||||0.082
74015029|NCT03594227|147581058|SUPERIORITY|||||||0.313|||||||Wilcoxon (Mann-Whitney)|||||||0.313
74015030|NCT03594227|147581059|SUPERIORITY|||||||0.883|||||||Wilcoxon (Mann-Whitney)|||||||0.883
74015031|NCT03594227|147581059|SUPERIORITY|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||||||0.954
74015032|NCT03594227|147581059|SUPERIORITY|||||||0.295|||||||Wilcoxon (Mann-Whitney)|||||||0.295
74015033|NCT03594227|147581060|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
74015034|NCT03594227|147581060|SUPERIORITY|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
74015035|NCT03594227|147581060|SUPERIORITY|||||||0.815|||||||Wilcoxon (Mann-Whitney)|||||||0.815
74015036|NCT03594227|147581061|SUPERIORITY|||||||0.522|||||||Wilcoxon (Mann-Whitney)|||||||0.522
74015037|NCT03594227|147581061|SUPERIORITY|||||||0.104|||||||Wilcoxon (Mann-Whitney)|||||||0.104
74015038|NCT03594227|147581061|SUPERIORITY|||||||0.414|||||||Wilcoxon (Mann-Whitney)|||||||0.414
74015039|NCT03594227|147581062|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.93||0.882|TWO_SIDED|95.0|-2.53|2.94|||Mixed Models Analysis|||||2.94|-2.53|0.882
74015040|NCT03594227|147581062|SUPERIORITY||Mean Difference (Net)|-3.58|STANDARD_ERROR_OF_MEAN|0.93||0.011|TWO_SIDED|95.0|-6.31|-0.84|||Mixed Models Analysis|||||-0.84|-6.31|0.011
74015041|NCT03594227|147581062|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.951||0.999|TWO_SIDED|95.0|-2.76|2.76|||Mixed Models Analysis|||||2.76|-2.76|0.999
74015042|NCT03594227|147581063|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
74044368|NCT01484561|147640105|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.95|||||TWO_SIDED|90.0|0.92|0.98|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||0.98|0.92|
74044369|NCT01484561|147640106|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||TWO_SIDED|90.0|0.97|1.02|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.02|0.97|
74044370|NCT01484561|147640107|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|1.01|1.07|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.07|1.01|
74044371|NCT01484561|147640108|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.05|||||TWO_SIDED|90.0|1.02|1.08|||ANCOVA||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.08|1.02|
74044372|NCT01484561|147640109|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.01|||||TWO_SIDED|90.0|0.98|1.04|||ANCOVA||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.04|0.98|
74044373|NCT01484561|147640110|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.97|||||TWO_SIDED|90.0|0.94|1.0|||ANCOVA||ANCOVA with change in logarithmic creatinine from Period 2 baseline/the end of Period 1 as dependent variable, treatment and Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.00|0.94|
74044374|NCT01484561|147640111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.16|STANDARD_ERROR_OF_MEAN|7.64|<|0.001|TWO_SIDED|90.0|23.6|48.73||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 1||48.73|23.60|<0.001
74044375|NCT01484561|147640111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.95|STANDARD_ERROR_OF_MEAN|8.14||0.05|TWO_SIDED|90.0|2.56|29.34||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 2||29.34|2.56|0.050
74044376|NCT01484561|147640112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.02|STANDARD_ERROR_OF_MEAN|5.94|<|0.001|TWO_SIDED|90.0|11.24|30.8||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 1||30.80|11.24|<0.001
74044377|NCT01484561|147640112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_ERROR_OF_MEAN|6.13||0.006|TWO_SIDED|90.0|6.92|27.08||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 2||27.08|6.92|0.006
74044378|NCT01484561|147640113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.56|STANDARD_ERROR_OF_MEAN|3.95|<|0.001|TWO_SIDED|90.0|12.06|25.05||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 1||25.05|12.06|<0.001
74044379|NCT01484561|147640113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.32|STANDARD_ERROR_OF_MEAN|3.53||0.038|TWO_SIDED|90.0|1.51|13.12||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 2||13.12|1.51|0.038
74044380|NCT01484561|147640114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|90.0|-1.53|-0.78||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.78|-1.53|<0.001
74095199|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74044381|NCT01484561|147640115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.21||0.028|TWO_SIDED|90.0|-0.83|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.12|-0.83|0.028
74044382|NCT01484561|147640116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.22||0.002|TWO_SIDED|90.0|0.32|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.04|0.32|0.002
74044383|NCT01484561|147640117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|-1.67|-0.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.84|-1.67|<0.001
74095200|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74095201|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74015043|NCT03594227|147581063|SUPERIORITY|||||||0.319|||||||Wilcoxon (Mann-Whitney)|||||||0.319
74015044|NCT03594227|147581063|SUPERIORITY|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||||||0.094
74044384|NCT01484561|147640118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.031|TWO_SIDED|90.0|-0.88|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.12|-0.88|0.031
74095202|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
74095203|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
74095204|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
74095205|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74095206|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|< 0.001
74095207|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74095208|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001||95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||71.00|45.24|< 0.001
74095209|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
74095210|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|< 0.001
74095211|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||64.09|37.39|<0.001
74095212|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74095213|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||16.97|-1.15|0.087
74095214|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
74095215|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
74015045|NCT03594227|147581064|SUPERIORITY|||||||0.584|||||||Wilcoxon (Mann-Whitney)|||||||0.584
74015046|NCT03594227|147581064|SUPERIORITY|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||||||0.287
74015047|NCT03594227|147581064|SUPERIORITY|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||||||0.144
74015048|NCT03594227|147581065|SUPERIORITY|||||||0.341|||||||Wilcoxon (Mann-Whitney)|||||||0.341
74015049|NCT03594227|147581065|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
74015050|NCT03594227|147581065|SUPERIORITY|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
74015051|NCT03594227|147581066|SUPERIORITY|||||||0.827|||||||Wilcoxon (Mann-Whitney)|||||||0.827
74015052|NCT03594227|147581066|SUPERIORITY|||||||0.742|||||||Wilcoxon (Mann-Whitney)|||||||0.742
74015053|NCT03594227|147581066|SUPERIORITY|||||||0.462|||||||Wilcoxon (Mann-Whitney)|||||||0.462
74015054|NCT03594227|147581067|SUPERIORITY|||||||0.836|||||||Wilcoxon (Mann-Whitney)|||||||0.836
74015055|NCT03594227|147581067|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.540
74015056|NCT03594227|147581067|SUPERIORITY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||0.672
74015057|NCT03594227|147581068|SUPERIORITY|||||||0.469|||||||Wilcoxon (Mann-Whitney)|||||||0.469
74015058|NCT03594227|147581068|SUPERIORITY|||||||0.219|||||||Wilcoxon (Mann-Whitney)|||||||0.219
74015059|NCT03594227|147581068|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
74095216|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
74095217|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74095218|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74015060|NCT01888640|147581069|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.008|TWO_SIDED|95.0|-1.8|-0.2||To account for multiple tests involving pairwise treatment group comparisons, p-values were adjusted using Bonferroni's method|Linear mixed models for repeated measure|||Visit 2-Visit 3||-0.2|-1.8|0.008
74015061|NCT01888640|147581069|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-2.6|<0.0001
74015062|NCT01888640|147581070|SUPERIORITY||Mean Difference (Net)|-1.3||||0.002|TWO_SIDED|95.0|-2.2|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.2|0.002
74015063|NCT01888640|147581070|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-2.8|<0.0001
74015064|NCT01888640|147581071|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.0006|TWO_SIDED|95.0|-2.1|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.1|0.0006
74015065|NCT01888640|147581071|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.6|-2.2|<0.0001
74015066|NCT01888640|147581072|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.001|TWO_SIDED|95.0|-2.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.4|0.001
74015067|NCT01888640|147581072|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.9|-0.9|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.9|-2.9|<0.0001
74015068|NCT01888640|147581073|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.011|TWO_SIDED|95.0|-2.2|-0.2|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.2|-2.2|0.011
74015069|NCT01888640|147581073|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-3.0|<0.0001
74015070|NCT01888640|147581074|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.016|TWO_SIDED|95.0|-2.2|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.1|-2.2|0.016
74015071|NCT01888640|147581074|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.0002|TWO_SIDED|95.0|-2.6|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.6|-2.6|0.0002
74015072|NCT01888640|147581075|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.074|TWO_SIDED|95.0|-10.4|0.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||0.3|-10.4|0.074
74015073|NCT01888640|147581075|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.005|TWO_SIDED|95.0|-12.4|-1.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.8|-12.4|0.005
74015074|NCT01888640|147581076|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.018|TWO_SIDED|95.0|-1.7|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.1|-1.7|0.018
74015075|NCT01888640|147581076|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.0006|TWO_SIDED|95.0|-1.9|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-1.9|0.0006
74015076|NCT01888640|147581077|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.043|TWO_SIDED|95.0|-1.3|-0.01|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.01|-1.3|0.043
74015077|NCT01888640|147581077|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.048|TWO_SIDED|95.0|-1.3|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.0|-1.3|0.048
74015078|NCT01888640|147581078|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.036|TWO_SIDED|95.0|-1.0|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.0|-1.0|0.036
74015079|NCT01888640|147581078|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-1.4|<0.0001
74015080|NCT01888640|147581079|SUPERIORITY||Mean Difference (Final Values)|-0.4|||>|0.99|TWO_SIDED|95.0|-2.3|1.5|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.5|-2.3|>0.99
74015081|NCT01888640|147581079|SUPERIORITY||Mean Difference (Final Values)|-0.6|||>|0.99|TWO_SIDED|95.0|-2.4|1.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.3|-2.4|>0.99
74015082|NCT01888640|147581080|SUPERIORITY||Mean Difference (Final Values)|1.1|||>|0.99|TWO_SIDED|95.0|-1.9|4.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||4.1|-1.9|>0.99
74015083|NCT01888640|147581080|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.17|TWO_SIDED|95.0|-0.6|5.3|||Linear mixed models for repeated measure|||||5.3|-0.6|0.17
74015084|NCT01888640|147581081|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.36|TWO_SIDED|95.0|-0.7|3.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||3.1|-0.7|0.36
74015085|NCT01888640|147581081|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.58|TWO_SIDED|95.0|-0.8|2.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||2.8|-0.8|0.58
74015086|NCT01888640|147581082|SUPERIORITY||Mean Difference (Final Values)|19.0|||>|0.99|TWO_SIDED|95.0|-58.0|96.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||96|-58|>0.99
74015087|NCT01888640|147581082|SUPERIORITY||Mean Difference (Final Values)|42.0|||>|0.99|TWO_SIDED|95.0|-34.0|117.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||117|-34|>0.99
74015088|NCT01888640|147581083|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.96|TWO_SIDED|95.0|-0.2|0.7|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||0.7|-0.2|0.96
74015089|NCT01888640|147581083|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.008|TWO_SIDED|95.0|0.1|1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.0|0.1|0.008
74015090|NCT01888640|147581084|SUPERIORITY||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3||||>0.99
74015091|NCT01888640|147581084|SUPERIORITY||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3||||>0.99
74015092|NCT03389854|147581089|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.001
74044385|NCT01484561|147640119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.24||0.002|TWO_SIDED|90.0|0.36|1.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.15|0.36|0.002
74095219|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74095220|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
74015093|NCT03389854|147581089|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 6 months||||0.90
74015094|NCT03389854|147581090|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.001
74015095|NCT03389854|147581090|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Control group vs. Penile Traction Therapy Group at 6 months||||0.40
74015096|NCT03389854|147581091|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.01
74015097|NCT03389854|147581091|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Control group vs. Penile Traction Therapy Group at 6 months||||0.64
74015098|NCT03389854|147581092|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.06
74015099|NCT03389854|147581092|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 6 months||||0.66
74015100|NCT03389854|147581093|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
74015101|NCT03389854|147581094|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
74015102|NCT03389854|147581095|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
74015103|NCT00960843|147581138|SUPERIORITY_OR_OTHER|||||||0.052||95.0|||||t-test, 2 sided|||Null hypothesis was no difference between arms. Original power calculation specified 24 per group and this was achieved under initial randomization. However, due to failure to follow protocol specified adjustment criteria, pressure and weight data from one site had to be excluded.||||0.0520
74015104|NCT00960843|147581139|SUPERIORITY_OR_OTHER|||||||0.0225||95.0|||||t-test, 2 sided|||||||0.0225
74015105|NCT00960843|147581140|SUPERIORITY_OR_OTHER|||||||0.0193||95.0|||||t-test, 2 sided|||||||0.0193
74015106|NCT00652366|147581142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.2026|TWO_SIDED|95.0|0.88|1.8|||Log Rank|||||1.80|0.88|0.2026
74015107|NCT00652366|147581144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.6298|TWO_SIDED|95.0|0.77|1.54|||Log Rank|||||1.54|0.77|0.6298
74044386|NCT01484561|147640120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.09|STANDARD_ERROR_OF_MEAN|2.02||0.045|TWO_SIDED|90.0|-7.44|-0.74||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.74|-7.44|0.045
74015108|NCT00652366|147581145|SUPERIORITY_OR_OTHER||Difference in Response Rates|-6.1||||0.2543|TWO_SIDED|95.0|-17.2|5.0|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||5.0|-17.2|0.2543
74015109|NCT00652366|147581145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.19|1.56||||||||1.56|0.19|
74015110|NCT00652366|147581147|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-15.52||||0.0603|TWO_SIDED|95.0|-32.4|1.3|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||1.3|-32.4|0.0603
74015111|NCT00652366|147581149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.2678|TWO_SIDED|95.0|0.6|1.15|||Log Rank|||||1.15|0.60|0.2678
74015112|NCT00652366|147581149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.8449|TWO_SIDED|95.0|0.74|1.43|||Log Rank|||||1.43|0.74|0.8449
74015113|NCT00652366|147581151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.0217|TWO_SIDED|95.0|0.51|0.95|||Log Rank|||||0.95|0.51|0.0217
74015114|NCT00652366|147581151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.1596|TWO_SIDED|95.0|0.57|1.1|||Log Rank|||||1.10|0.57|0.1596
74015115|NCT01181011|147581185|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.22|STANDARD_ERROR_OF_MEAN|1.06||0.0107||90.0|99.45|119.95||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||119.95|99.45|0.0107
74015116|NCT01181011|147581186|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.84|STANDARD_ERROR_OF_MEAN|1.06||0.0139|TWO_SIDED|90.0|99.96|120.71||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||120.71|99.96|0.0139
74015117|NCT01181011|147581187|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|97.57|STANDARD_ERROR_OF_MEAN|1.09||0.0126|TWO_SIDED|90.0|84.643|112.472||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||112.472|84.643|0.0126
74015118|NCT01181011|147581188|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.7|STANDARD_ERROR_OF_MEAN|1.04||0.0011|TWO_SIDED|90.0|102.87|117.07||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||117.07|102.87|0.0011
74015119|NCT01181011|147581189|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|108.8|STANDARD_ERROR_OF_MEAN|1.04||0.0006|TWO_SIDED|95.0|102.1|116.0||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||116.0|102.1|0.0006
74015120|NCT01181011|147581190|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|106.7|STANDARD_ERROR_OF_MEAN|1.03||0|TWO_SIDED|90.0|100.9|112.9||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||112.9|100.9|0.000
74044387|NCT01484561|147640121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.76||0.936|TWO_SIDED|90.0|-2.78|3.06||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||3.06|-2.78|0.936
74044388|NCT01484561|147640122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|1.93||0.03|TWO_SIDED|90.0|1.04|7.42||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||7.42|1.04|0.030
74095221|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
74095222|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
74095223|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74095224|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74095225|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74095226|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
74095227|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
74095228|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
74015121|NCT00137111|147581207|SUPERIORITY_OR_OTHER_LEGACY||Binomial proportion|79.27|||||TWO_SIDED|95.0|75.69|82.85|||Binomial proportion|||Of the 498 eligible patients, 492 were successfully evaluated with day 46 MRD measurement.||82.85|75.69|
74015122|NCT00137111|147581208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062||||||p-value from t-test after stratified for lineage and ploidy|t-test, 2 sided|||t-test stratified for lineage and ploidy||||.0062
74015123|NCT00137111|147581209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||p-value from t-test after adjusted for lineage and ploidy|t-test, 2 sided|||t-test adjusting for lineage and ploidy||||.15
74015124|NCT00137111|147581210|SUPERIORITY_OR_OTHER_LEGACY|||||||9.5e-07|||||||Wilcoxon (Mann-Whitney)|||||||0.00000095
74015125|NCT00137111|147581211|SUPERIORITY_OR_OTHER_LEGACY|||||||7e-07|||||||Wilcoxon (Mann-Whitney)|||||||0.0000007
74015126|NCT04703075|147581212|SUPERIORITY||Risk Difference (RD)|5.5||||0.07|TWO_SIDED||||||Chi-squared, Corrected|||||||0.07
74044389|NCT01484561|147640123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26|STANDARD_ERROR_OF_MEAN|1.03||0.03|TWO_SIDED|90.0|-3.96|-0.55||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.55|-3.96|0.030
74044390|NCT01484561|147640124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.11||0.472|TWO_SIDED|90.0|-2.64|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.04|-2.64|0.472
74044391|NCT01484561|147640125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|1.03||0.158|TWO_SIDED|90.0|-0.24|3.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||3.15|-0.24|0.158
74044392|NCT01484561|147640126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.73|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|90.0|-19.87|-7.59||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.59|-19.87|<0.001
74044393|NCT01484561|147640127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.89|STANDARD_ERROR_OF_MEAN|4.04||0.029|TWO_SIDED|90.0|-15.58|-2.21||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-2.21|-15.58|0.029
74044394|NCT01484561|147640128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.84|STANDARD_ERROR_OF_MEAN|2.98||0.107|TWO_SIDED|90.0|-0.1|9.77||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||9.77|-0.10|0.107
74044395|NCT01484561|147640129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|4.87||0.001|TWO_SIDED|90.0|-23.96|-7.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.84|-23.96|0.001
74044396|NCT01484561|147640130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|4.95||0.251|TWO_SIDED|90.0|-13.9|2.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||2.50|-13.90|0.251
74044397|NCT01484561|147640131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.19|STANDARD_ERROR_OF_MEAN|4.42||0.023|TWO_SIDED|90.0|2.87|17.52||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||17.52|2.87|0.023
74044398|NCT01484561|147640132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.12|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|90.0|-21.58|-8.67||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-8.67|-21.58|<0.001
74044399|NCT01484561|147640133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.77||0.616|TWO_SIDED|90.0|-10.3|5.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||5.50|-10.30|0.616
74044400|NCT01484561|147640134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.72|STANDARD_ERROR_OF_MEAN|4.17||0.003|TWO_SIDED|90.0|5.82|19.62||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||19.62|5.82|0.003
74095229|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74044401|NCT01484561|147640135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|90.0|-22.78|-7.82||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.82|-22.78|<0.001
74044402|NCT01484561|147640136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.62|STANDARD_ERROR_OF_MEAN|4.83||0.247|TWO_SIDED|90.0|-13.62|2.38||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||2.38|-13.62|0.247
74044403|NCT01484561|147640137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.68|STANDARD_ERROR_OF_MEAN|4.67||0.04|TWO_SIDED|90.0|1.95|17.41||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||17.41|1.95|0.040
74044404|NCT01484561|147640138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|90.0|-0.56|-0.23||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.23|-0.56|<0.001
74015127|NCT01223703|147581215|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.||"null hypothesis is no difference n3 PUFA administration and placebo. To demonstrate an effect size of 0.5 in LVEF, a sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with alpha=0.05 (2-tailed) at the Student t test.~for unpaired data."||||< 0.05
74015128|NCT01223703|147581216|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.||||||< 0.05
74015129|NCT04249687|147581219|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
74015130|NCT04249687|147581220|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
74044405|NCT01484561|147640139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.09||0.053|TWO_SIDED|90.0|-0.31|-0.03||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.03|-0.31|0.053
74044406|NCT01484561|147640140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|90.0|0.1|0.35||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||0.35|0.10|0.003
74044407|NCT01784614|147640141|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.96||||0.908|TWO_SIDED|90.0|0.56|1.65|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 0.1 mg LY2624803 / Placebo.|||1.65|0.56|0.908
74044408|NCT01784614|147640141|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.67||||0.083|TWO_SIDED|90.0|0.45|0.98|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 1.0 mg LY2624803 / Placebo.|||0.98|0.45|0.083
74044409|NCT01784614|147640141|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.53||||0.01|TWO_SIDED|90.0|0.36|0.78|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 3.0 mg LY2624803 / Placebo.|||0.78|0.36|0.010
74044410|NCT01784614|147640141|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.3|||<|0.001|TWO_SIDED|90.0|0.18|0.51|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 6.0 mg LY2624803 / Placebo.|||0.51|0.18|<0.001
74044411|NCT03371251|147640147|SUPERIORITY||Observed Difference vs. Placebo|2.0||||0.8434|TWO_SIDED|90.0|-14.5|18.5|||Pearson's chi-square test|||Statistical Analysis: SRI-4 Response||18.5|-14.5|0.8434
74044412|NCT03371251|147640147|SUPERIORITY||Observed Difference vs. Placebo|2.0||||0.8434|TWO_SIDED|90.0|-14.5|18.5|||Pearson's chi-square test|||Statistical Analysis: \>= 4-Point Reduction from Baseline in SLEDAI-2K Global Score||18.5|-14.5|0.8434
74044413|NCT03371251|147640147|SUPERIORITY||Observed Difference vs. Placebo|17.7||||0.0141|TWO_SIDED|90.0|4.5|30.9|||Pearson's chi-square test|||Statistical Analysis: No New BILAG A or More than One BILAG B Organ Score Compared with Baseline||30.9|4.5|0.0141
74044414|NCT03371251|147640147|SUPERIORITY||Observed Difference vs. Placebo|17.7||||0.0141|TWO_SIDED|90.0|4.5|30.9|||Pearson's chi-square test|||Statistical Analysis: No Deterioration from Baseline in PGA by \>=30mm||30.9|4.5|0.0141
74044415|NCT03371251|147640163|SUPERIORITY||Observed Difference vs. Placebo|-2.6||||0.7985|TWO_SIDED|90.0|-19.8|14.5|||Pearson's chi-square test|||||14.5|-19.8|0.7985
74044416|NCT03371251|147640164|SUPERIORITY||Observed Difference vs. Placebo|-6.9||||0.3498|TWO_SIDED|90.0|-22.9|9.8|||Pearson's chi-square test|||Statistical Analysis for Overall||9.8|-22.9|0.3498
74044417|NCT03371251|147640165|SUPERIORITY||Observed Difference vs. Placebo|-21.8||||0.0072|TWO_SIDED|90.0|-36.2|-7.4|||Pearson's chi-square test|||Statistical analysis for Overall||-7.4|-36.2|0.0072
74015131|NCT02425826|147581221|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-39.84|||<|0.0001|TWO_SIDED|95.0|-54.39|-25.3|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||||-25.30|-54.39|<0.0001
74015132|NCT02425826|147581222|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.5||||0.0008|TWO_SIDED|95.0|-3.9|-1.0|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||||-1.0|-3.9|0.0008
74015133|NCT02425826|147581223|SUPERIORITY_OR_OTHER_LEGACY||Difference|21.0|||<|0.0001|TWO_SIDED|95.0|11.0|31.1||Two-sided p-value is based on the Cochran-Mantel-Haenszel test stratified by sites.|Cochran-Mantel-Haenszel||Two-sided 95% confidence intervals (CI) is based on normal approximation|||31.1|11.0|<0.0001
74015134|NCT02425826|147581224|SUPERIORITY_OR_OTHER_LEGACY||Difference|13.7||||0.0365|TWO_SIDED|95.0|1.7|25.7|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation|||25.7|1.7|0.0365
74015135|NCT02425826|147581225|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-11.6||||0.0016|TWO_SIDED|95.0|-18.8|-4.5|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||The treatment comparison was only done for Week 16; End of Phase||-4.5|-18.8|0.0016
74015136|NCT02425826|147581226|SUPERIORITY_OR_OTHER_LEGACY||Difference|11.8||||0.0463|TWO_SIDED|95.0|-4.0|27.6|||Cochran-Mantel-Haenszel|p-value was based on 2-sided CMH tests stratified by sites.|Two-sided 95% CI is based on normal approximation.|||27.6|-4.0|0.0463
74044418|NCT03371251|147640165|SUPERIORITY||Observed Difference vs. Placebo|-17.7||||0.0141|TWO_SIDED|90.0|-30.9|-4.5|||Pearson's chi-square test|||Statistical Analysis for Day 210||-4.5|-30.9|0.0141
74044419|NCT03371251|147640166|SUPERIORITY||Observed Difference vs. Placebo|4.9||||0.6107|TWO_SIDED|90.0|-10.7|20.5|||Pearson's chi-square test|||||20.5|-10.7|0.6107
74044420|NCT03371251|147640167|SUPERIORITY||Observed Difference vs. Placebo|15.4||||0.1237|TWO_SIDED|90.0|-0.9|31.8|||Pearson's chi-square test|||||31.8|-0.9|0.1237
74044421|NCT03371251|147640168|SUPERIORITY||Observed Difference vs. Placebo|-13.7||||0.0581|TWO_SIDED|90.0|-26.7|-0.7|||Pearson's chi-square test|||Statistical Analysis for Overall||-0.7|-26.7|0.0581
74044422|NCT03371251|147640168|SUPERIORITY||Observed Difference vs. Placebo|-14.3||||0.0471|TWO_SIDED|90.0|-31.2|3.2|||Pearson's chi-square test|||Statistical Analysis for Day 210||3.2|-31.2|0.0471
74015137|NCT02425826|147581227|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|17.8|||<|0.0001|TWO_SIDED|95.0|10.36|25.24|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM-Effectiveness||25.24|10.36|<0.0001
74015138|NCT02425826|147581227|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.0||||0.3433|TWO_SIDED|95.0|-5.4|15.4|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM - Side Effects||15.40|-5.40|0.3433
74015139|NCT02425826|147581227|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.4||||0.625|TWO_SIDED|95.0|-4.25|7.06|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSMQ-Convenience||7.06|-4.25|0.6250
74015140|NCT02425826|147581227|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.07|||<|0.0001|TWO_SIDED|95.0|7.16|20.97|||ANOVA|||TSQM-Global Satisfaction||20.97|7.16|<0.0001
74015141|NCT02425826|147581229|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-37.0|||<|0.0001|TWO_SIDED|95.0|-54.08|-19.91|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate||||-19.91|-54.08|<0.0001
74015142|NCT02425826|147581230|SUPERIORITY_OR_OTHER_LEGACY||Difference|29.1|||<|0.0001|TWO_SIDED|95.0|16.3|41.8|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation|||41.8|16.3|<0.0001
74015143|NCT02425826|147581231|SUPERIORITY_OR_OTHER_LEGACY||Difference|13.5||||0.0136|TWO_SIDED|95.0|4.4|22.7|||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test stratified by sites.|2-sided 95% CI is based on normal approximation.|||22.7|4.4|0.0136
74015144|NCT02997904|147581236|SUPERIORITY||Least Squares Mean Difference|1.0058|STANDARD_ERROR_OF_MEAN|0.2131|<|0.0001|TWO_SIDED|95.0|0.5829|1.4288|||ANOVA|||Ho: Total Number of lice and eggs removed with Resultz® ≤ Total number of lice and eggs removed with sham control Ha: Total Number of lice and eggs removed with Resultz® \> Total Number of lice and eggs removed with sham control||1.4288|0.5829|<0.0001
74044423|NCT03371251|147640169|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|-0.3|STANDARD_ERROR_OF_MEAN|0.78||0.6596|TWO_SIDED|90.0|-1.63|0.94|||ANCOVA||This is based on LS Means|Statistical Analysis for CLASI-A (Total Activity)||0.94|-1.63|0.6596
74044424|NCT03371251|147640169|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.3|STANDARD_ERROR_OF_MEAN|0.33||0.4105|TWO_SIDED|90.0|-0.27|0.81|||ANCOVA||This is based on LS Means|Statistical Analysis for CLASI-B (Total Damage)||0.81|-0.27|0.4105
74044425|NCT03371251|147640170|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|4.11||0.8546|TWO_SIDED|90.0|-6.07|7.58|||ANCOVA||This is based on LS Means|Statistical Analysis for Day 210||7.58|-6.07|0.8546
74015145|NCT02997904|147581237|SUPERIORITY||Least Squares Mean Difference|1.2084|STANDARD_ERROR_OF_MEAN|0.0467|<|0.0001|TWO_SIDED|95.0|1.1157|1.3011||The P-Values were \<0.0001 in both comparison groups; total number lice removed and total number of eggs removed|GLIMMX|||Comparison of total number of lice removed and total number of eggs removed were analyzed separately||1.3011|1.1157|<0.0001
74015146|NCT02997904|147581237|SUPERIORITY||Least Squares Mean Difference|0.7899|STANDARD_ERROR_OF_MEAN|0.04565|<|0.0001|TWO_SIDED|95.0|0.6993|0.8805|||GLIMMX|||||0.8805|0.6993|<0.0001
74015147|NCT04036968|147581238|SUPERIORITY|Comparison of three drug conditions with cannabidiol to control groups placebo+placebo and hydromorphone+placebo||||||0.195|||||||ANOVA|||||||0.195
74015148|NCT04036968|147581239|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
74015149|NCT04036968|147581240|SUPERIORITY|||||||0.074|||||||ANOVA|||||||0.074
74015150|NCT00853671|147581242|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson Correlation|||||||<0.0001
74015151|NCT00853671|147581244|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson Correlation|||Pearson Correlation||||<0.0001
74015152|NCT02043548|147581256|SUPERIORITY|||||||0.86|||||||GEE|||||||0.86
74015153|NCT02043548|147581257|SUPERIORITY|||||||0.77|||||||Log Rank|||||||0.77
74015154|NCT02043548|147581258|SUPERIORITY|||||||0.4|||||||binomial test|||||||0.40
74044426|NCT03371251|147640171|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4455|TWO_SIDED|90.0|-0.63|1.71|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Swelling for Day 210||1.71|-0.63|0.4455
74044427|NCT03371251|147640171|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.9|STANDARD_ERROR_OF_MEAN|0.94||0.3367|TWO_SIDED|90.0|-0.65|2.47|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Tenderness for Day 210||2.47|-0.65|0.3367
74015155|NCT02043548|147581259|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
74015156|NCT02043548|147581260|SUPERIORITY|||||||0.78|||||||GEE|||||||0.78
74015157|NCT02043548|147581260|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
74015158|NCT00507559|147581263|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||This is compared to a historical control group, in which 11.1% of subjects experienced one or more MAE within 30 days.||||<0.001
74015159|NCT01314716|147581274|SUPERIORITY_OR_OTHER||Differences in least squares mean|4.6||||0.011|TWO_SIDED|95.0|1.1|8.2||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||8.2|1.1|0.011
74015160|NCT01314716|147581275|SUPERIORITY_OR_OTHER||Difference in least squares mean|1.1||||0.56|TWO_SIDED|95.0|-2.7|5.0||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||5.0|-2.7|0.56
74015161|NCT04311502|147581277|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.21|TWO_SIDED|90.0|0.82|1.79|||Regression, Cox|Adjusted for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).|Arm 1 vs Arm 2|This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||1.79|0.82|0.21
74015162|NCT04311502|147581278|SUPERIORITY||Risk Difference (RD)|0.3|||<|0.01|TWO_SIDED|90.0|0.14|0.45|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|"The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.~This outcome measure is limited to data obtained up to September 25, 2023."||0.45|0.14|<0.01
74015163|NCT04311502|147581278|SUPERIORITY||Risk Difference (RD)|0.28|||<|0.01|TWO_SIDED|90.0|0.11|0.44|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|"The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.~All data through week 65."||0.44|0.11|<0.01
74015164|NCT04311502|147581279|SUPERIORITY||Risk Difference (RD)|-0.26||||0.01|TWO_SIDED|95.0|-0.47|-0.06|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.||-0.06|-0.47|0.01
74015165|NCT04311502|147581280|SUPERIORITY||Risk Difference (RD)|-0.25||||0.02|TWO_SIDED|95.0|-0.46|-0.04|||Wald chi-square||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.||-0.04|-0.46|0.02
74015166|NCT04311502|147581281|SUPERIORITY|Fisher's exact test was used to test for a difference in proportions|Risk Difference (RD)|-0.06||||0.35|TWO_SIDED|95.0|-0.22|0.05|||Fisher Exact||Difference in proportions (Arm 1 - Arm 2); exact confidence interval|||0.05|-0.22|0.35
74015167|NCT04311502|147581283|SUPERIORITY||GEE|24.04|||<|0.01|TWO_SIDED|95.0|15.13|32.94|||Regression, Linear|||||32.94|15.13|<0.01
74015168|NCT04311502|147581285|SUPERIORITY||Odds Ratio (OR)|7.15|||<|0.01|TWO_SIDED|95.0|2.4|21.3|||Regression, Logistic|||Compares the odds of participants having maximum occurrence of QTcF change from baseline of ≥30 ms and \<60 ms, or ≥60 ms between Arm 1 and Arm 2 in the safety set using the proportional odds model.||21.30|2.40|<0.01
74015169|NCT04311502|147581285|SUPERIORITY||Risk Difference (RD)|0.41|||<|0.01|TWO_SIDED|95.0|0.17|0.58|||exact unconditional||Arm 1 - Arm 2|Proportion of Participants with Worst Changes in QTcF from Screening \>= 30 ms over visits at Weeks 2, 8, 13||0.58|0.17|<0.01
74015170|NCT04311502|147581286|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.18|TWO_SIDED|90.0|0.84|1.8||One-sided p-value|Regression, Cox|Adjusted for HIV status (positive/negative) and TB disease according to chest X-ray (advanced/not advanced)|Arm 1 vs. Arm 2|||1.80|0.84|0.18
74015171|NCT04311502|147581287|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.25|TWO_SIDED|90.0|0.8|1.71||One-sided p-value|Regression, Cox|||This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||1.71|0.80|0.25
74015172|NCT04311502|147581288|SUPERIORITY||Risk Difference (RD)|0.13||||0.23|TWO_SIDED|95.0|-0.07|0.35|||Fisher Exact|||||0.35|-0.07|0.23
74015173|NCT04311502|147581289|SUPERIORITY||Risk Difference (RD)|0.05||||0.56|TWO_SIDED|95.0|-0.11|0.24|||Fisher Exact|||||0.24|-0.11|0.56
74015174|NCT04311502|147581290|SUPERIORITY||Risk Difference (RD)|0.07||||0.27|TWO_SIDED|90.0|-0.04|0.18|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing an SAE through week 65 was compared between Arm 1 and Arm 2.||0.18|-0.04|0.27
74015175|NCT04311502|147581291|SUPERIORITY|Fisher's exact test was used to test for a difference in proportions|Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-0.1|0.13|||Fisher Exact||Difference in proportions (Arm 1 - Arm 2); exact confidence interval|||0.13|-0.10|1
74015176|NCT04311502|147581292|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.597|TWO_SIDED|95.0|0.57|1.39|||Regression, Cox|||Time point: Screening||1.39|0.57|0.597
74015177|NCT04311502|147581292|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.58|1.44|||Regression, Cox|||Time point: Entry||1.44|0.58|0.70
74015178|NCT04311502|147581292|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.07|TWO_SIDED|95.0|0.4|1.03|||Regression, Cox|||Time point: Week 2||1.03|0.40|0.07
74015179|NCT04311502|147581292|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.04|TWO_SIDED|95.0|0.34|0.98|||Regression, Cox|||Time point: Week 4||0.98|0.34|0.04
74015180|NCT04311502|147581292|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.6|TWO_SIDED|95.0|0.41|1.67|||Regression, Cox|||Time point: Week 6||1.67|0.41|0.60
74015181|NCT04311502|147581292|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.595|TWO_SIDED|95.0|0.33|1.88|||Regression, Cox|||Time point: Week 8||1.88|0.33|0.595
74015182|NCT04311502|147581292|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.66|TWO_SIDED|95.0|0.25|2.44|||Regression, Cox|||Time point: Week 10||2.44|0.25|0.66
74015183|NCT04311502|147581292|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.86|TWO_SIDED|95.0|0.21|6.39|||Regression, Cox|||Time point: Week 12||6.39|0.21|0.86
74015184|NCT04311502|147581293|SUPERIORITY||Slope|20.43|||<|0.01|TWO_SIDED|95.0|5.71|35.16|||Regression, Linear|||This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||35.16|5.71|<0.01
74015185|NCT03040999|147581305|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1997|TWO_SIDED|95.0|0.71|1.15|||Log Rank|One-sided p-value based on log-rank test stratified by human papilloma virus (HPV) status and overall cancer stage.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by HPV status and overall cancer stage.|||1.15|0.71|0.1997
74015186|NCT03040999|147581308|OTHER||Difference in Least squares mean|-4.24||||0.0015|TWO_SIDED|95.0|-6.85|-1.63|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||-1.63|-6.85|0.0015
74015187|NCT03040999|147581309|OTHER||Difference in Least squares mean|-0.51||||0.7719|TWO_SIDED|95.0|-3.98|2.96|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||2.96|-3.98|0.7719
74015188|NCT03040999|147581310|OTHER||Difference in Least squares mean|-1.29||||0.45|TWO_SIDED|95.0|-4.64|2.06|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||2.06|-4.64|0.4500
74015189|NCT03040999|147581311|OTHER||Difference in Least squares mean|1.29||||0.3524|TWO_SIDED|95.0|-1.43|4.02|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||4.02|-1.43|0.3524
74044428|NCT03371251|147640171|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|0.66||0.255|TWO_SIDED|90.0|-0.34|1.86|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Active Joints for Day 210||1.86|-0.34|0.2550
74044429|NCT03371251|147640172|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|0.68||0.2498|TWO_SIDED|90.0|-0.34|1.93|||ANCOVA||This is based on LS Means|||1.93|-0.34|0.2498
74044430|NCT03371251|147640173|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.2558|TWO_SIDED|90.0|-0.02|0.12|||ANCOVA||This is based on LS Means|Statistical Analysis for Day 180||0.12|-0.02|0.2558
74044431|NCT03371251|147640174|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.0479|TWO_SIDED|90.0|0.18|0.88|||Log Rank||Hazard rate of BOS161721 120 mg / Hazard rate of placebo|||0.88|0.18|0.0479
74044432|NCT03371251|147640176|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|4.4|STANDARD_ERROR_OF_MEAN|16.4||0.7898|TWO_SIDED|90.0|-22.92|31.7|||ANOVA||This is based on LS Means|||31.70|-22.92|0.7898
74044433|NCT03371251|147640177|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.0083|TWO_SIDED|90.0|0.16|0.68|||Log-Rank Test (2-Sided)||Hazard rate of BOS161721 120mg / Hazard rate of placebo|||0.68|0.16|0.0083
74044434|NCT03168555|147640182|EQUIVALENCE|compares visit 1 with visit 2||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
74044435|NCT03168555|147640184|EQUIVALENCE|compares visit 1 with visit 2||||||0.63|||||||paired t-test|lognormalized values||compares visit 1 with visit 2||||0.63
74044436|NCT03168555|147640185|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
74044437|NCT03168555|147640186|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
74044438|NCT03168555|147640187|OTHER|Spearman correlation||||||0.41|||||||Spearman correlation|||||||0.41
74044439|NCT03168555|147640188|OTHER|Spearman correlation||||||0.35|||||||Spearman correlation|||||||0.35
74044440|NCT03168555|147640188|OTHER|||||||0.03|||||||Spearman correlation|||||||0.03
74044441|NCT03168555|147640189|EQUIVALENCE|comparing visit 1 with visit 2||||||0.36|||||||paired t-test|||||||0.36
74044442|NCT03168555|147640190|SUPERIORITY|||||||0.29|||||||paired t-test|||||||0.29
74044443|NCT03168555|147640191|OTHER|Spearman correlation||||||0.73|||||||Spearman correlation|||||||0.73
74044444|NCT03168555|147640191|OTHER|||||||0.77|||||||Spearman correlation|||||||0.77
74044445|NCT03168555|147640192|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
74044446|NCT04445688|147640216|SUPERIORITY||difference in Least Squares Mean|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.2|-4.4|||ANOVA|||||-4.4|-10.2|<0.0001
74044447|NCT04445688|147640217|SUPERIORITY||difference in Least Squares Mean|-21.8|||<|0.0001|TWO_SIDED|95.0|-29.5|-14.1|||ANOVA|||||-14.1|-29.5|<0.0001
74044448|NCT04445688|147640218|SUPERIORITY||difference in Least Squares Mean|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.5|-4.2|||ANOVA|||||-4.2|-10.5|<0.0001
74044449|NCT01235507|147640225|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
74044450|NCT01235507|147640225|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
74044451|NCT01235507|147640225|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
74044452|NCT01235507|147640227|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
74044453|NCT01235507|147640227|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
74044454|NCT01235507|147640227|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
74044455|NCT01235507|147640228|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
74044456|NCT01235507|147640228|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
74044457|NCT01235507|147640228|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
74044458|NCT01235507|147640229|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
74044459|NCT01235507|147640229|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
74044460|NCT01235507|147640229|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
74044461|NCT01235507|147640230|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
74044462|NCT01235507|147640230|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
74044463|NCT01235507|147640230|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
74044464|NCT01235507|147640231|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
74044465|NCT01235507|147640231|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
74044466|NCT01235507|147640231|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
74044467|NCT01235507|147640232|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
74095230|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74095231|NCT02912650|147740357|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74095232|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.16||||0.156|TWO_SIDED|95.0|-0.44|2.75|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.75|-0.44|0.156
74095233|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.16||||0.155|TWO_SIDED|95.0|-0.44|2.76|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.76|-0.44|0.155
74095234|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.68||||0.605|TWO_SIDED|95.0|-3.27|1.9|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||1.90|-3.27|0.605
74095235|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.84||||0.079|TWO_SIDED|95.0|-0.21|3.89|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.89|-0.21|0.079
74095236|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-1.85||||0.078|TWO_SIDED|95.0|-3.9|0.21|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.21|-3.90|0.078
74095237|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|21.47|||<|0.001|TWO_SIDED|95.0|15.33|27.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||27.62|15.33|<0.001
74095238|NCT02912650|147740358|SUPERIORITY_OR_OTHER||Cumulative Percentage of Participants wi|7.79||||0.056|TWO_SIDED|95.0|-0.19|15.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.77|-0.19|0.056
74095239|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.37||||0.934|TWO_SIDED|95.0|-9.18|8.43|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.43|-9.18|0.934
74095240|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.67|||<|0.001|TWO_SIDED|95.0|8.58|18.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.77|8.58|<0.001
74095241|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|21.96|||<|0.001|TWO_SIDED|95.0|15.64|28.28|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||28.28|15.64|<0.001
74095242|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.21||||0.05|TWO_SIDED|95.0|-16.4|-0.01|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.01|-16.40|0.050
74095243|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|55.89|||<|0.001|TWO_SIDED|95.0|47.05|64.73|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.73|47.05|<0.001
74095244|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|12.99||||0.015|TWO_SIDED|95.0|2.5|23.49|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.49|2.50|0.015
74095245|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.16||||0.188|TWO_SIDED|95.0|-3.51|17.82|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.82|-3.51|0.188
74095246|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.61|||<|0.001|TWO_SIDED|95.0|33.85|51.38|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||51.38|33.85|<0.001
74095247|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|48.58|||<|0.001|TWO_SIDED|95.0|39.63|57.54|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.54|39.63|<0.001
74095248|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-5.98||||0.266|TWO_SIDED|95.0|-16.51|4.55|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||4.55|-16.51|0.266
74095249|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|59.77|||<|0.001|TWO_SIDED|95.0|49.63|69.9|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.90|49.63|<0.001
74095250|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.62||||0.094|TWO_SIDED|95.0|-1.46|18.69|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.69|-1.46|0.094
74095251|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.43||||0.047|TWO_SIDED|95.0|0.15|20.72|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||20.72|0.15|0.047
74095252|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.95|||<|0.001|TWO_SIDED|95.0|40.5|61.4|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||61.40|40.50|<0.001
74044468|NCT01235507|147640232|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
74095253|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|49.34|||<|0.001|TWO_SIDED|95.0|38.79|59.89|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.89|38.79|<0.001
74095254|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.79||||0.734|TWO_SIDED|95.0|-8.56|12.14|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||12.14|-8.56|0.734
74095255|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.46|||<|0.001|TWO_SIDED|95.0|46.88|70.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||70.03|46.88|<0.001
74095256|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.01||||0.152|TWO_SIDED|95.0|-2.57|16.59|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.59|-2.57|0.152
74095257|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.0||||0.073|TWO_SIDED|95.0|-0.83|19.82|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||19.82|-0.83|0.073
74095258|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.3|||<|0.001|TWO_SIDED|95.0|39.38|63.21|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||63.21|39.38|<0.001
74095259|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|49.49|||<|0.001|TWO_SIDED|95.0|37.5|61.47|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||61.47|37.50|<0.001
74095260|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.99||||0.694|TWO_SIDED|95.0|-7.91|11.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||11.89|-7.91|0.694
74044469|NCT01235507|147640232|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
74044470|NCT00918346|147640257|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type 1 error rate of 5%.|Mean Difference (Final Values)|0.01||||0.96||95.0|-0.46|0.49|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4.|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation||0.49|-0.46|0.96
74095261|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.61|||<|0.001|TWO_SIDED|95.0|48.37|72.84|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.84|48.37|<0.001
74095262|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.58||||0.135|TWO_SIDED|95.0|-2.05|15.2|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.20|-2.05|0.135
74095263|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|14.74||||0.002|TWO_SIDED|95.0|5.5|23.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.97|5.50|0.002
74095264|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.82|||<|0.001|TWO_SIDED|95.0|41.31|66.32|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||66.32|41.31|<0.001
74044471|NCT00918346|147640258|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type I error rate of 5%.|Median Difference (Final Values)|-0.05||||0.83||95.0|-0.52|0.42|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation||0.42|-0.52|0.83
74044472|NCT01815580|147640317|OTHER||||||>|0.75|||||||Chi-squared|||||||>0.75
74044473|NCT01815580|147640318|OTHER|||||||0.14|||||||t-test, 2 sided|||||||0.14
74044474|NCT01815580|147640319|OTHER||||||>|0.3|||||||Chi-squared|||||||>0.3
74044475|NCT01815580|147640320|OTHER||||||>|0.12|||||||Chi-squared|||||||>0.12
74044476|NCT01815580|147640321|OTHER||||||>|0.22|||||||Chi-squared|||||||>0.22
74044477|NCT02228564|147640322|NON_INFERIORITY|"The sample size calculation assumes the following:~The LIFESTREAM™ Covered Stent composite event rate is estimated at 10.5% The Performance Goal is set at 19.5% The Type 1 error, α = 0.05 (one-sided). The Type 2 error, β = 0.10 (Power = 1 - β = 90%). The calculated sample size is 139 subjects to be followed through the 9-month follow-up visit (using nQuery 7.0). To accommodate 10% censoring, the sample size is increased to 154."|||||<|0.0325|||||||Exact binomial test|||"H0: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is greater than or equal to that of the PG of 19.5%.~H1: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is less than that of the PG of 19.5%."||||<0.0325
74044478|NCT01262599|147640334|SUPERIORITY|Applies to primary and secondary outcomes: Data were analyzed using one-way analysis of variance, one-way repeated measures analysis of variance, t test, or Mann-Whitney rank sum test, as appropriate. (SigmaStat 3.5; Systat Software, Inc., San Jose, Calif.). Intention-to-treat using last value carried forward was used for missing data.|||||<|0.01|||||||ANOVA|||Before the start of this study, a sample size analysis, assuming a clinically meaningful 50± 40 percent (mean ± SD) decrease in pain scores from pulsed electromagnetic field treatment, suggested that a minimum of 11 patients per group were needed.||||<0.01
74044479|NCT01269047|147640337|OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|2.4||0.04|TWO_SIDED|95.0|-4.2|-0.2|||ANOVA|||||-0.2|-4.2|0.04
74044480|NCT01269047|147640337|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_DEVIATION|2.7||0.008|TWO_SIDED|95.0|-5.8|-1.3|||ANOVA|||||-1.3|-5.8|0.008
74044481|NCT01269047|147640337|OTHER||Mean Difference (Final Values)|-4.2|STANDARD_DEVIATION|2.6||0.003|TWO_SIDED|95.0|-6.4|-2.0|||ANOVA|||||-2.0|-6.4|0.003
74044482|NCT01269047|147640337|OTHER||Mean Difference (Final Values)|-0.66|STANDARD_DEVIATION|2.0||0.37|TWO_SIDED|95.0|-2.3|0.98|||ANOVA|||||0.98|-2.3|0.37
74044483|NCT01269047|147640338|OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.8||0.2|TWO_SIDED|95.0|-0.21|0.81|||t-test, 2 sided|||||0.81|-0.21|0.2
74044484|NCT01269047|147640338|OTHER||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|0.6||0.48|TWO_SIDED|95.0|-0.25|0.5|||t-test, 2 sided|||||0.50|-0.25|0.48
74044485|NCT01269047|147640338|OTHER||Mean Difference (Final Values)|0.23|STANDARD_DEVIATION|0.6||0.18|TWO_SIDED|95.0|-0.12|0.57|||t-test, 2 sided|||||0.57|-0.12|0.18
74044486|NCT01269047|147640338|OTHER||Mean Difference (Final Values)|-0.004|STANDARD_DEVIATION|1.0||1|TWO_SIDED|95.0|-0.62|0.61|||t-test, 2 sided|||||0.61|-0.62|1.0
74044487|NCT01711658|147640372|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.3436|TWO_SIDED|95.0|0.56|1.46|||Log Rank|One-sided significance level = 0.1803|Reference level = IMRT + cisplatin + placebo|Hazard ratio (lapatinib/placebo) set at 0.65 (35% reduction), 1-sided alpha 0.20 (final test at 0.1803 accounting for 1 interim analysis), logrank test, 80% power, 69 events in 128 randomized (142 total enrolled) patients required. Final analysis at 67 (of 69) events drops power to 79%.||1.46|0.56|0.3436
74044488|NCT01711658|147640373|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.5836|TWO_SIDED|95.0|0.61|1.86|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||1.86|0.61|0.5836
74044489|NCT01711658|147640374|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.1743|TWO_SIDED|95.0|0.25|1.65|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||1.65|0.25|0.1743
74044490|NCT01711658|147640375|SUPERIORITY|||||||0.7989|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.7989
74044491|NCT01711658|147640376|SUPERIORITY|||||||0.3728||||||IMRT|Fisher Exact|Two-sided significance level = 0.05||||||0.3728
74044492|NCT01711658|147640376|OTHER|||||||0.7781||||||Cisplatin|Fisher Exact|Two-sided significance level = 0.05||||||0.7781
74044493|NCT01711658|147640376|OTHER|||||||0.8||||||Pre-IMRT lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.8000
74044494|NCT01711658|147640376|OTHER|||||||0.6459||||||Concurrent lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.6459
74044495|NCT01711658|147640376|OTHER|||||||0.4792||||||Maintenance lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.4792
74044496|NCT01711658|147640377|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.6735|TWO_SIDED|95.0|0.62|2.17|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||2.17|0.62|0.6735
74044497|NCT00249795|147640414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.857|TWO_SIDED|95.0|0.907|1.085||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 4.5% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.|||1.085|0.907|0.8570
74044498|NCT00249795|147640415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.12|TWO_SIDED|95.0|0.869|1.016||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 1% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.|||1.016|0.869|0.1200
74044499|NCT00249795|147640416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.916||||0.2162|TWO_SIDED|95.0|0.796|1.053||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of a stroke in Irbesartan group versus Placebo group.|||1.053|0.796|0.2162
74044500|NCT00249795|147640417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014||||0.759|TWO_SIDED|95.0|0.927|1.11||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of death in Irbesartan group versus Placebo group.|||1.110|0.927|0.7590
74044501|NCT00249795|147640418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.897||||0.0369|TWO_SIDED|95.0|0.809|0.993||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of HF episodes in Irbesartan group versus Placebo group.|||0.993|0.809|0.0369
74044502|NCT00249795|147640419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.0175|TWO_SIDED|95.0|0.763|0.975||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for Heart Failure in Irbesartan group versus Placebo group.|||0.975|0.763|0.0175
74044503|NCT00249795|147640420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008||||0.8377|TWO_SIDED|95.0|0.93|1.093||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for other CV cause in Irbesartan group versus Placebo group.|||1.093|0.930|0.8377
74044504|NCT02460978|147640426|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.0579|<|0.0001|TWO_SIDED|95.0|-0.49|-0.26|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline||-0.26|-0.49|<0.0001
74044505|NCT02460978|147640426|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.0578|<|0.0001|TWO_SIDED|95.0|-0.53|-0.3|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline||-0.30|-0.53|<0.0001
74044506|NCT02460978|147640427|SUPERIORITY||Mean Difference (Final Values)|-10.78|STANDARD_ERROR_OF_MEAN|1.5291|<|0.0001|TWO_SIDED|95.0|-13.73|-7.72|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-7.72|-13.73|<0.0001
74044507|NCT02460978|147640427|SUPERIORITY||Mean Difference (Final Values)|-11.08|STANDARD_ERROR_OF_MEAN|1.5331|<|0.0001|TWO_SIDED|95.0|-14.04|-8.02|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-8.02|-14.04|<0.0001
74044508|NCT02460978|147640428|SUPERIORITY||Mean Difference (Final Values)|-3.21|STANDARD_ERROR_OF_MEAN|0.3829|<|0.0001|TWO_SIDED|95.0|-3.96|-2.45|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-2.45|-3.96|<0.0001
74044509|NCT02460978|147640428|SUPERIORITY||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|0.3812|<|0.0001|TWO_SIDED|95.0|-4.49|-2.99|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-2.99|-4.49|<0.0001
74044510|NCT02460978|147640429|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|2.3468|<|0.0001|TWO_SIDED|95.0|-20.26|-11.05|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-11.05|-20.26|<0.0001
74044511|NCT02460978|147640429|SUPERIORITY||Mean Difference (Final Values)|-19.74|STANDARD_ERROR_OF_MEAN|2.3419|<|0.0001|TWO_SIDED|95.0|-24.34|-15.14|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-15.14|-24.34|<0.0001
74044512|NCT02460978|147640430|SUPERIORITY||Mean Difference (Final Values)|-9.85|STANDARD_ERROR_OF_MEAN|2.4519|<|0.0001|TWO_SIDED|95.0|-14.66|-5.03|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-5.03|-14.66|<0.0001
74044513|NCT02460978|147640430|SUPERIORITY||Mean Difference (Final Values)|-9.36|STANDARD_ERROR_OF_MEAN|2.4487||0.0001|TWO_SIDED|95.0|-14.16|-4.55|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-4.55|-14.16|0.0001
74015190|NCT03040999|147581312|OTHER||Difference in Least squares mean|-2.05||||0.0963|TWO_SIDED|95.0|-4.47|0.37|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||0.37|-4.47|0.0963
74044514|NCT02460978|147640431|SUPERIORITY||Mean Difference (Final Values)|9.02|STANDARD_ERROR_OF_MEAN|1.0415|<|0.0001|TWO_SIDED|95.0|6.97|11.06|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||11.06|6.97|<0.0001
74044515|NCT02460978|147640431|SUPERIORITY||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|1.0396|<|0.0001|TWO_SIDED|95.0|8.66|12.74|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||12.74|8.66|<0.0001
74044516|NCT02460978|147640432|SUPERIORITY||Odds Ratio (OR)|2.71|STANDARD_ERROR_OF_MEAN|0.2058|<|0.0001|TWO_SIDED|95.0|1.81|4.06|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo||4.06|1.81|<0.0001
74044517|NCT02460978|147640432|SUPERIORITY||Odds Ratio (OR)|3.07|STANDARD_ERROR_OF_MEAN|0.2054|<|0.0001|TWO_SIDED|95.0|2.05|4.6|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo||4.60|2.05|<0.0001
74044518|NCT03549429|147640439|SUPERIORITY||Percent difference|8.0||||0.03|TWO_SIDED|95.0|1.5|14.4|||McNemar|||We compared the proportion of patients who had postoperative eyelid erythema with Tegaderm™ to those who had postop eyelid erythema with EyeGard®.||14.4|1.5|0.03
74044519|NCT03549429|147640440|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.23|TWO_SIDED||||||t-test, 2 sided|paired||||||0.23
74044520|NCT01459068|147640453|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.59|-0.4||a priori threshold for statistical significance was 0.05.|longitudinal model|longitudinal to model within-person change in mean scores||||-0.40|-0.59|<0.001
74044521|NCT01459068|147640454|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|power calculations were not done for secondary outcomes|Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.59|-0.28|||longitudinal model|||||-0.28|-0.59|<0.001
74044522|NCT01459068|147640455|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.51|-0.35||a priori threshold for significance set at 0.05|longitudinal model|longitudinal analysis modeling within-person change in mean scores||||-0.35|-0.51|<0.001
74015191|NCT03040999|147581313|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0429|TWO_SIDED|95.0|0.68|1.03||P-value crossing boundary of 0.0242 required for statistical significance.|Log Rank|One-sided p-value based on log-rank test stratified by human papilloma virus (HPV) status and overall cancer stage.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by HPV status and overall cancer stage.|||1.03|0.68|0.0429
74015192|NCT03257267|147581339|SUPERIORITY||Hazard Ratio (HR)|0.665|||<|1e-05|TWO_SIDED|95.0|0.555|0.796||One-sided p-value|Stratified Log-rank Test|||||0.796|0.555|<0.00001
74015193|NCT03257267|147581340|SUPERIORITY||Hazard Ratio (HR)|0.741||||0.00031|TWO_SIDED|95.0|0.623|0.882|||Stratified Log-rank Test|||||0.882|0.623|0.00031
74015194|NCT03257267|147581341|SUPERIORITY||Odds Ratio (OR)|3.136||||2e-05|TWO_SIDED|95.0|1.798|5.468|||Stratified Cochran-Mantel-Haenszel test|||||5.468|1.798|0.00002
74015195|NCT03257267|147581346|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.00024|TWO_SIDED|95.0|0.57|0.855||One-sided p-value|Stratified Log-rank Test|||||0.855|0.570|0.00024
74015196|NCT01979523|147581347|OTHER|||||||0.74|||||||Log Rank|||||||0.74
74015197|NCT01982292|147581361|SUPERIORITY_OR_OTHER||Difference in percentage|0.5|||>|0.9999|TWO_SIDED|90.0|-9.38|10.38|||Fisher Exact|||Difference in percentage of patients with positive antibody status||10.38|-9.38|>0.9999
74015198|NCT01982292|147581361|SUPERIORITY_OR_OTHER||Difference in percentage|-0.5|||||TWO_SIDED|90.0|-10.38|9.38||||||Difference in percentage of patients with negative antibody status||9.38|-10.38|
74015199|NCT00746252|147581370|OTHER|||||||0.495||||||Threshold of significance is p\<.05|t-test, 2 sided|||Comparison of mean weight gain between groups.||||.495
74015200|NCT01870401|147581385|NON_INFERIORITY|The protocol identified a non-inferiority bound equal to 0.12 (12%).|||||<|0.025|||||||Farrington and Manning|||The primary safety hypothesis is as follows: H0: pControl - pDCB ≥ and H1: pControl (alpha) pDCB \< where p is the success rate in each arm and (alpha) is the non-inferiority bound.||||<0.025
74015201|NCT01870401|147581386|SUPERIORITY|||||||0.0222|||||||Wald Test|One-sided Wald test based on model estimate of DCB treatment effect and subject as a random effect.||||||0.0222
74015202|NCT04623242|147581412|SUPERIORITY||Ratio|1.063|STANDARD_DEVIATION|0.059|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
74015203|NCT04623242|147581412|SUPERIORITY||Ratio|1.255|STANDARD_DEVIATION|0.061|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
74015204|NCT04623242|147581413|OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.094||0.805|TWO_SIDED|95.0|-2.46|1.92|||t-test, 2 sided|||||1.92|-2.46|0.805
73880196|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0177|TWO_SIDED|95.0|1.34|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.93|1.34|0.0177
74044523|NCT01459068|147640456|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations on secondary outcomes|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.61|-0.34|||longitudinal model|||||-0.34|-0.61|<0.001
74044524|NCT01459068|147640457|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations for secondary measures|Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.34|-0.15|||longitudinal model|||||-0.15|-0.34|<0.001
74044525|NCT01459068|147640458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations for secondary measures|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.26||0.896|TWO_SIDED|95.0|-0.44|0.5|||longitudinal model|||||0.50|-0.44|0.896
74044526|NCT01685203|147640488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381|TWO_SIDED||||||Regression, Logistic|Treatment group, baseline log(subscript)10(subscript) HCV RNA level and Interleukin-28B (IL28B) genotype (CC or non-CC) were used as predictors||||||0.381
74044527|NCT01685203|147640488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086|TWO_SIDED|||||Difference in rates after adjusting for Interleukin-28 (IL28) genotype (CC or Non-CC) using stratum-adjusted Mantel-Haenszel proportions and continuity-corrected variances.|Stratum-adjusted Mantel-Haenszel|||||||0.086
74044528|NCT05302804|147640509|SUPERIORITY|||||||0.742||||||p-value reflects main effect of treatment.|ANOVA|||"Null hypothesis was there was no difference between menthol gel and control gel~time x trial ANOVA statistical analysis"||||0.742
74044529|NCT05302804|147640510|SUPERIORITY|||||||0.742||||||p-value is main effect of menthol|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||0.742
74044530|NCT05302804|147640511|SUPERIORITY|||||||0.048||||||p-value reflects main effect of menthol|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||0.048
74044531|NCT05302804|147640512|SUPERIORITY|||||||0.104|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between menthol and control trials||||.104
74044532|NCT05302804|147640513|SUPERIORITY|||||||0.051|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between menthol and control trials||||.051
74044533|NCT05302804|147640514|SUPERIORITY||||||<|0.001||||||Main effect of treatment|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||< 0.001
74044534|NCT05302804|147640515|SUPERIORITY|||||||0.026|||||||ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||.026
74044535|NCT05302804|147640516|SUPERIORITY|||||||0.001||||||p-value at time 30 min of exercise|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||.001
74044536|NCT05302804|147640517|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
74044537|NCT03300427|147640603|SUPERIORITY||difference in least square means|-900.0||||0.7594|TWO_SIDED|95.0|-6781.7|4981.8|||ANCOVA|||The study hypothesis is that short-term therapy with sacubitril/valsartan added on standard HF therapy improves cardiac efficiency in subjects with systolic HF.||4981.8|-6781.7|0.7594
74044538|NCT03300427|147640605|SUPERIORITY||difference in least square means|-575.5||||0.8422|TWO_SIDED|95.0|-6365.5|5214.5|||ANCOVA|||The study hypothesis is that short-term therapy with sacubitril/valsartan added on standard HF therapy improves cardiac efficiency in subjects with systolic HF.||5214.5|-6365.5|0.8422
74044539|NCT03250624|147640606|SUPERIORITY||Least Square (LS) Mean Difference|-0.28||||0.632|TWO_SIDED|95.0|-1.46|0.89|||ANCOVA|||||0.89|-1.46|0.632
74044540|NCT00948428|147640630|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the PP population were contained within the interval -0.20 to +0.20, and each of these rates was greater than, and statistically different (p\<0.05) from, the Vehicle rate in the ITT population, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent|Mean Difference (Net)|-0.85|||||TWO_SIDED|90.0|-10.84|9.15||||||||9.15|-10.84|
74044541|NCT00948428|147640630|SUPERIORITY|||||||0.0001|||||||ANOVA|||Based on Intent-to-Treat Population||||0.0001
74044542|NCT00948428|147640631|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Partial Clearance rates in the PP population were contained within the interval -0.20 to +0.20, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.|Mean Difference (Net)|-3.1|||||TWO_SIDED|90.0|-12.11|5.95||||||||5.95|-12.11|
74044543|NCT00948428|147640632|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the ITT population were contained within the interval -0.20 to +0.20, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.|Mean Difference (Net)|-0.5|||||TWO_SIDED|90.0|-9.92|8.88||||||||8.88|-9.92|
73880197|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|5.38||||0.0178|TWO_SIDED|95.0|1.34|21.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.65|1.34|0.0178
74095265|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|45.93|||<|0.001|TWO_SIDED|95.0|33.21|58.66|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||58.66|33.21|<0.001
74095266|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.18||||0.091|TWO_SIDED|95.0|-1.32|17.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.69|-1.32|0.091
74095267|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.0|||<|0.001|TWO_SIDED|95.0|47.59|72.42|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.42|47.59|<0.001
74095268|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.03||||0.159|TWO_SIDED|95.0|-2.36|14.43|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.43|-2.36|0.159
74095269|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.32|||<|0.001|TWO_SIDED|95.0|6.23|24.41|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.41|6.23|<0.001
74095270|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.79|||<|0.001|TWO_SIDED|95.0|41.08|66.5|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||66.50|41.08|<0.001
74095271|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|44.76|||<|0.001|TWO_SIDED|95.0|31.72|57.81|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.81|31.72|<0.001
74095272|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.28||||0.052|TWO_SIDED|95.0|-0.08|18.64|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.64|-0.08|0.052
74095273|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.57|||<|0.001|TWO_SIDED|95.0|44.75|70.39|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||70.39|44.75|<0.001
74095274|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.06||||0.147|TWO_SIDED|95.0|-2.13|14.25|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.25|-2.13|0.147
73888036|NCT01746901|147309532|SUPERIORITY_OR_OTHER||LS Mean Difference|11.4||||0.02|TWO_SIDED|95.0|1.8|20.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.9|1.8|0.0200
74095275|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.3|||<|0.001|TWO_SIDED|95.0|6.39|24.21|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.21|6.39|<0.001
74095276|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.32|||<|0.001|TWO_SIDED|95.0|38.16|64.48|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.48|38.16|<0.001
74095277|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.28|||<|0.001|TWO_SIDED|95.0|28.74|55.82|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||55.82|28.74|<0.001
74095278|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.27||||0.049|TWO_SIDED|95.0|0.04|18.49|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.49|0.04|0.049
74095279|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001|TWO_SIDED|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
74095280|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
74015205|NCT04623242|147581414|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|1.823||0.512|TWO_SIDED|95.0|-4.83|2.43|||t-test, 2 sided|||Test of equality (any treatment difference)||2.43|-4.83|0.512
74044544|NCT02864706|147640776|SUPERIORITY|||||||0.0043|||||||ANCOVA|Incidence of CAV at 5-7 yrs was compared between groups using Cochran-Mantel-Haenszel test with stratification according to baseline distribution||||||0.0043
74044545|NCT02864706|147640777|SUPERIORITY|||||||0.037|||||||Cochran-Mantel-Haenszel|||||||0.037
74044546|NCT01599806|147640819|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Difference of symp resolution rates|4.0|||||TWO_SIDED|95.0|-2.39|10.42|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin||10.42|-2.39|
74044547|NCT01599806|147640820|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable combined resp rates|6.7|||||TWO_SIDED|95.0|0.3|13.12|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin||13.12|0.30|
74044548|NCT01599806|147640821|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable response rates|6.4|||||TWO_SIDED|95.0|0.33|12.36|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin||12.36|0.33|
74044549|NCT01599806|147640822|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.4|||||TWO_SIDED|95.0|-2.7|3.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||3.56|-2.70|
74044550|NCT01599806|147640823|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.68|13.81|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.81|0.68|
74044551|NCT01599806|147640824|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.21|1.72|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.72|-1.21|
74044552|NCT01599806|147640825|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.8|||||TWO_SIDED|95.0|2.27|15.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||15.24|2.27|
74044553|NCT01599806|147640826|SUPERIORITY_OR_OTHER||Diff of favorable response rates|10.9|||||TWO_SIDED|95.0|2.86|18.85|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||18.85|2.86|
74044554|NCT01599806|147640827|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.17|1.68|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.68|-1.17|
74044555|NCT01599806|147640828|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.88|13.74|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.74|0.88|
74044556|NCT01599806|147640829|SUPERIORITY_OR_OTHER||Diff of favorable response rates|9.7|||||TWO_SIDED|95.0|1.72|17.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||17.55|1.72|
74095281|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.86|||<|0.001|TWO_SIDED|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.63|7.08|<0.001
74095282|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
74095283|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.94|||<|0.001|TWO_SIDED|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.44|29.44|<0.001
74095284|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.23||||0.048|TWO_SIDED|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.40|0.06|0.048
74095285|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001|TWO_SIDED|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
74095286|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
74095287|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.86|||<|0.001|TWO_SIDED|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.63|7.08|<0.001
74095288|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
74095289|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.94|||<|0.001|TWO_SIDED|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.44|29.44|<0.001
74095290|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.23||||0.048|TWO_SIDED|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.40|0.06|0.048
74095291|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||71.49|45.93|<0.001
74095292|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||14.67|-1.38|0.105
74095293|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.23|||<|0.001|TWO_SIDED|95.0|6.48|23.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.97|6.48|<0.001
74095294|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001||95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
73880198|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|1.17||||0.8564|TWO_SIDED|95.0|0.22|6.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.20|0.22|0.8564
74044557|NCT01599806|147640830|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.4|||||TWO_SIDED|95.0|-4.07|1.02|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.02|-4.07|
74044558|NCT01599806|147640831|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-4.23|4.03|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.03|-4.23|
74044559|NCT01599806|147640832|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.3|||||TWO_SIDED|95.0|-3.71|6.3|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.30|-3.71|
74044560|NCT01599806|147640833|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.3|||||TWO_SIDED|95.0|-3.64|0.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.55|-3.64|
74044561|NCT01599806|147640834|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.2|||||TWO_SIDED|95.0|-2.03|4.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.56|-2.03|
74044562|NCT01599806|147640835|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.2|||||TWO_SIDED|95.0|-2.9|7.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.24|-2.90|
74044563|NCT01599806|147640836|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.9|||||TWO_SIDED|95.0|-4.3|0.04|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.04|-4.30|
74044564|NCT01599806|147640837|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.1|||||TWO_SIDED|95.0|-2.07|4.32|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.32|-2.07|
74095295|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.61|||<|0.001|TWO_SIDED|95.0|30.15|57.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.07|30.15|<0.001
74095296|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.61||||0.065|TWO_SIDED|95.0|-0.55|17.76|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.76|-0.55|0.065
74095297|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
74095298|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
74044565|NCT01599806|147640838|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.0|||||TWO_SIDED|95.0|-2.94|6.91|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.91|-2.94|
74044566|NCT01599806|147640839|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-1.99|1.61|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.61|-1.99|
74044567|NCT01599806|147640840|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|3.7|||||TWO_SIDED|95.0|0.41|7.16|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.16|0.41|
74044568|NCT01599806|147640841|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|4.0|||||TWO_SIDED|95.0|-1.0|9.05|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||9.05|-1.00|
74044569|NCT01599806|147640842|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|0.0|||||TWO_SIDED|95.0|-10.4|10.1|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.1|-10.4|
74044570|NCT01599806|147640843|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.4|||||TWO_SIDED|95.0|-7.8|10.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.2|-7.8|
74044571|NCT01599806|147640844|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.2|||||TWO_SIDED|95.0|-7.5|9.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||9.2|-7.5|
74044572|NCT01599806|147640845|SUPERIORITY_OR_OTHER||Diff of favorable response rates|2.0|||||TWO_SIDED|95.0|-13.18|16.89|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||16.89|-13.18|
74044573|NCT01599806|147640846|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.0|||||TWO_SIDED|95.0|-10.03|25.21|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||25.21|-10.03|
74044574|NCT01599806|147640847|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.5|||||TWO_SIDED|95.0|-9.91|24.01|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||24.01|-9.91|
74044575|NCT01599806|147640848|SUPERIORITY_OR_OTHER|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.038
74044576|NCT01599806|147640849|SUPERIORITY_OR_OTHER|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.129
74044577|NCT01599806|147640850|SUPERIORITY_OR_OTHER|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.080
74044578|NCT01599806|147640851|SUPERIORITY_OR_OTHER|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.155
74095299|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
74044579|NCT01263314|147640919|OTHER||Mean Difference (Final Values)|-1.25||||0.3551|TWO_SIDED|90.0|-7.01|4.5|||ANOVA|||||4.50|-7.01|0.3551
74044580|NCT01263314|147640919|OTHER||Mean Difference (Final Values)|-1.32||||0.3474|TWO_SIDED|90.0|-7.08|4.48|||ANOVA|||||4.48|-7.08|0.3474
74044581|NCT01263314|147640919|OTHER||Mean Difference (Final Values)|-1.67||||0.3105|TWO_SIDED|90.0|-7.42|4.09|||ANOVA|||||4.09|-7.42|0.3105
74044582|NCT01263314|147640919|OTHER||Mean Difference (Final Values)|-6.25||||0.1346|TWO_SIDED|90.0|-15.8|3.27|||ANOVA|||||3.27|-15.8|0.1346
74044583|NCT01263314|147640919|OTHER||Mean Difference (Final Values)|-10.1||||0.0416|TWO_SIDED|90.0|-19.6|-0.56|||ANOVA|||||-0.56|-19.6|0.0416
74044584|NCT01263314|147640919|OTHER||Mean Difference (Final Values)|-8.2||||0.0762|TWO_SIDED|90.0|-17.7|1.32|||ANOVA|||||1.32|-17.7|0.0762
74044585|NCT01263314|147640920|OTHER||Mean Difference (Final Values)|0.47||||0.418|TWO_SIDED|90.0|-3.47|4.41|||ANOVA|||||4.41|-3.47|0.418
74044586|NCT01263314|147640920|OTHER||Mean Difference (Final Values)|4.12||||0.0434|TWO_SIDED|90.0|0.18|8.05|||ANOVA|||||8.05|0.18|0.0434
74044587|NCT01263314|147640920|OTHER||Mean Difference (Final Values)|7.79||||0.0019|TWO_SIDED|90.0|3.85|11.72|||ANOVA|||||11.72|3.85|0.0019
74044588|NCT01263314|147640920|OTHER||Mean Difference (Final Values)|1.15||||0.2223|TWO_SIDED|90.0|-1.42|3.71|||ANOVA|||||3.71|-1.42|0.2223
74044589|NCT01263314|147640920|OTHER||Mean Difference (Final Values)|4.25||||0.0056|TWO_SIDED|90.0|1.69|6.82|||ANOVA|||||6.82|1.69|0.0056
74044590|NCT01263314|147640920|OTHER||Mean Difference (Final Values)|5.4||||0.0012|TWO_SIDED|90.0|2.83|7.96|||ANOVA|||||7.96|2.83|0.0012
74095300|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
74044591|NCT01263314|147640922|OTHER||GMR (Elderly female/Elderly male)|1.23|||||TWO_SIDED|90.0|0.85|1.76|||||GMR = geometric mean ratio|||1.76|0.85|
74044592|NCT01263314|147640923|OTHER||GMR (Elderly female/Elderly male)|1.08|||||TWO_SIDED|90.0|0.88|1.33||||||||1.33|0.88|
74044593|NCT01263314|147640923|OTHER||GMR (Elderly female/Elderly male)|1.26|||||TWO_SIDED|90.0|1.02|1.55||||||||1.55|1.02|
74044594|NCT01263314|147640923|OTHER||GMR (Elderly female/Elderly male)|1.2|||||TWO_SIDED|90.0|0.98|1.48||||||||1.48|0.98|
74044595|NCT01263314|147640926|SUPERIORITY||MK-8266 0.3 mg vs. placebo|9.58||||0.0253|TWO_SIDED|90.0|1.69|17.46|||ANOVA|||||17.46|1.69|0.0253
74044596|NCT01263314|147640926|SUPERIORITY||MK-8266 0.6 mg vs. placebo|-2.59||||0.2856|TWO_SIDED|90.0|-10.5|5.29|||ANOVA|||||5.29|-10.5|0.2856
74044597|NCT01263314|147640926|SUPERIORITY||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-4.06||||0.1895|TWO_SIDED|90.0|-11.9|3.82|||ANOVA|||||3.82|-11.9|0.1895
74044598|NCT01263314|147640926|SUPERIORITY||MK-8266 0.3 mg vs. placebo|-4.16||||0.1157|TWO_SIDED|90.0|-10.0|1.7|||ANOVA|||||1.70|-10.0|0.1157
74044599|NCT01263314|147640926|SUPERIORITY||MK-8266 0.6 mg vs. placebo|-11.7||||0.0018|TWO_SIDED|90.0|-17.5|-5.79|||ANOVA|||||-5.79|-17.5|0.0018
74044600|NCT01263314|147640926|SUPERIORITY||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-10.6||||0.0034|TWO_SIDED|90.0|-16.5|-4.77|||ANOVA|||||-4.77|-16.5|0.0034
74044601|NCT03689972|147640929|SUPERIORITY||Ratio of Mean|4.24|||=|0.0755|TWO_SIDED|95.0|0.86|20.85|||Negative Binomial Regression|The model included treatment as classification variable \& baseline body weight, duration of natalizumab exposure at baseline, \& region as covariates.||||20.85|0.86|=0.0755
74015206|NCT04623242|147581415|OTHER|Test of equality (any treatment difference)|Median Difference (Final Values)|-0.641|STANDARD_ERROR_OF_MEAN|0.1115|<|0.001|TWO_SIDED|95.0|-0.864|-0.417|||t-test, 2 sided|||||-0.417|-0.864|<0.001
74015207|NCT04623242|147581416|OTHER|Test of equality (any difference in the proportion of increase in the endpoint)|Ratio|0.3443||||0.5573|TWO_SIDED||||||Chi-squared|||||||0.5573
74015208|NCT04623242|147581417|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.092||0.707|TWO_SIDED|95.0|-1.77|2.6|||t-test, 2 sided|||||2.60|-1.77|0.707
74015209|NCT04623242|147581418|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.44||0.283|TWO_SIDED|95.0|-1.35|0.4|||t-test, 2 sided|||||0.40|-1.35|0.283
74015210|NCT04623242|147581419|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.859||0.674|TWO_SIDED|95.0|-1.34|2.07|||t-test, 2 sided|||||2.07|-1.34|0.674
74015211|NCT04623242|147581420|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|1.828||0.507|TWO_SIDED|95.0|-4.86|2.42|||t-test, 2 sided|||||2.42|-4.86|0.507
74015212|NCT04623242|147581421|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|1.706||0.553|TWO_SIDED|95.0|-4.41|2.38|||t-test, 2 sided|||||2.38|-4.41|0.553
74044602|NCT03689972|147640930|SUPERIORITY||Percentage|87.8|||||TWO_SIDED|95.0|80.68|93.01|||Exact Binomial method|Percentage of participants preferring natalizumab SC at end of crossover period of Part 2, and 95% CI was calculated using the exact binomial method.||||93.01|80.68|
74044603|NCT03689972|147640932|SUPERIORITY||Ratio of annualized relapse rate|1.32481|||=|0.6312|TWO_SIDED|95.0|0.42016|4.17725|||Poisson Regression|Poisson regression model was adjusted for baseline body weight, duration of natalizumab exposure at baseline, and region.||||4.17725|0.42016|=0.6312
74044604|NCT03689972|147640938|SUPERIORITY||Difference|0.47|||=|0.764|TWO_SIDED|95.0|-2.61|3.54||Performed with factors:route of administration,period,sequence,body weight,duration of natalizumab exposure,stratification factor,baseline TSQM score.|Linear Mixed Effects Model|||||3.54|-2.61|=0.764
74044605|NCT03689972|147640945|SUPERIORITY||Difference|0.08|||=|0.357|TWO_SIDED|95.0|-0.09|0.25||Performed with factors:route of administration,period,sequence,body weight,duration of natalizumab exposure,stratification factor,baseline TSQM score.|Linear Mixed Effects Model|||||0.25|-0.09|=0.357
74044606|NCT02417064|147640955|SUPERIORITY||Difference of Least Square (LS) Means|-3.2||||0.088|TWO_SIDED|95.0|-6.88|0.45|||Mixed Model for Repeated Measures|||||0.45|-6.88|0.088
74095301|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|44.89|||<|0.001||95.0|31.51|58.26|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||58.26|31.51|<0.001
74095302|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.36||||0.113|TWO_SIDED|95.0|-1.73|16.45|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.45|-1.73|0.113
74015213|NCT04623242|147581422|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.596||0.098|TWO_SIDED|95.0|-2.18|0.19|||t-test, 2 sided|||||0.19|-2.18|0.098
74015214|NCT04623242|147581423|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|2.73|STANDARD_ERROR_OF_MEAN|1.98||0.173|TWO_SIDED|95.0|-1.22|6.68|||t-test, 2 sided|||||6.68|-1.22|0.173
74015215|NCT04623242|147581424|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.998||0.94|TWO_SIDED|95.0|-8.1|8.71|||t-test, 2 sided|||||8.71|-8.10|0.940
74015216|NCT04623242|147581425|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|3.07|STANDARD_ERROR_OF_MEAN|16.524||0.854|TWO_SIDED|95.0|-30.49|36.62|||t-test, 2 sided|||||36.62|-30.49|0.854
74015217|NCT04623242|147581426|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|4.88|STANDARD_ERROR_OF_MEAN|17.448||0.781|TWO_SIDED|95.0|-30.0|39.75|||t-test, 2 sided|||||39.75|-30.00|0.781
74015218|NCT04623242|147581427|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|4.21||0.689|TWO_SIDED|95.0|-10.05|6.67|||t-test, 2 sided|||||6.67|-10.05|0.689
74015219|NCT04623242|147581428|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.689||0.474|TWO_SIDED|95.0|-1.86|0.87|||t-test, 2 sided|||||0.87|-1.86|0.474
74015220|NCT04623242|147581429|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.637||0.886|TWO_SIDED|95.0|-1.36|1.17|||t-test, 2 sided|||||1.17|-1.36|0.886
74015221|NCT04623242|147581430|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.556||0.873|TWO_SIDED|95.0|-1.03|1.2|||t-test, 2 sided|||||1.20|-1.03|0.873
74015222|NCT04623242|147581431|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|1.66||0.394|TWO_SIDED|95.0|-4.71|1.87|||t-test, 2 sided|||||1.87|-4.71|0.394
74015223|NCT04623242|147581432|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.063||0.776|TWO_SIDED|95.0|-2.41|1.81|||t-test, 2 sided|||||1.81|-2.41|0.776
74015224|NCT04623242|147581433|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.909||0.283|TWO_SIDED|95.0|-2.78|0.82|||t-test, 2 sided|||||0.82|-2.78|0.283
74015225|NCT04623242|147581434|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.947||0.634|TWO_SIDED|95.0|-2.33|1.42|||t-test, 2 sided|||||1.42|-2.33|0.634
74015226|NCT04623242|147581435|SUPERIORITY||Ratio|1.155|STANDARD_DEVIATION|0.074|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
74015227|NCT04623242|147581436|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.0562||0.726|TWO_SIDED|95.0|-0.093|0.132|||t-test, 2 sided|||||0.132|-0.093|0.726
74015228|NCT04623242|147581437|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.1056||0.439|TWO_SIDED|95.0|-0.13|0.295|||t-test, 2 sided|||||0.295|-0.130|0.439
74015229|NCT04623242|147581438|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.0168||0.967|TWO_SIDED|95.0|-0.034|0.033|||t-test, 2 sided|||||0.033|-0.034|0.967
73880199|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|2.52||||0.2202|TWO_SIDED|95.0|0.58|11.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.00|0.58|0.2202
74044607|NCT02417064|147640955|SUPERIORITY||Difference of Least Square (LS) Means|-4.1|||||TWO_SIDED|95.0|-7.67|-0.49||||||||-0.49|-7.67|
74095303|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
74095304|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
74095305|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
74095306|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74095307|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74015230|NCT04623242|147581439|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0377||0.669|TWO_SIDED|95.0|-0.059|0.092|||t-test, 2 sided|||||0.092|-0.059|0.669
74015231|NCT04623242|147581440|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-34.46|STANDARD_ERROR_OF_MEAN|116.419||0.768|TWO_SIDED|95.0|-264.14|195.22|||t-test, 2 sided|||||195.22|-264.14|0.768
74015232|NCT04623242|147581442|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-2737.62|STANDARD_ERROR_OF_MEAN|6558.467||0.677|TWO_SIDED|95.0|-15678.06|10202.81|||t-test, 2 sided|||||10202.81|-15678.06|0.677
74044608|NCT02417064|147640956|SUPERIORITY||Difference of Least Square (LS) Means|-2.0|||=|0.25|TWO_SIDED|95.0|-5.52|1.42|||ANCOVA|||||1.42|-5.52|= 0.250
74095308|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74095309|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
74044609|NCT02417064|147640956|SUPERIORITY||Difference of Least Square (LS) Means|-4.1|||||TWO_SIDED|95.0|-7.53|-0.6||||||||-0.6|-7.53|
74044610|NCT00371540|147640971|SUPERIORITY_OR_OTHER|||||||0.65|||||||Fisher Exact|||Note: The differences between the number of individuals evaluable for this secondary outcome and the number of individuals evaluable for the primary outcome is related to specimen loss by the laboratory. As such of the Routine care group only 96 of 102 patients completing the study were evaluable for the viral load outcome and only 86 of 87 patients in the Home visit group.||||0.65
74044611|NCT00371540|147640972|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
74095310|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
74015233|NCT04623242|147581443|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1078.32|STANDARD_ERROR_OF_MEAN|1788.474||0.547|TWO_SIDED|95.0|-4603.28|2446.64|||t-test, 2 sided|||||2446.64|-4603.28|0.547
74015234|NCT04623242|147581444|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1935.91|STANDARD_ERROR_OF_MEAN|385.538|<|0.001|TWO_SIDED|95.0|-2717.64|-1154.18|||t-test, 2 sided|||||-1154.18|-2717.64|<0.001
74015235|NCT04623242|147581445|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-77.12|STANDARD_ERROR_OF_MEAN|23.014||0.003|TWO_SIDED|95.0|-124.56|-29.68|||t-test, 2 sided|||||-29.68|-124.56|0.003
74015236|NCT04623242|147581446|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|30.89|STANDARD_ERROR_OF_MEAN|35.54||0.388|TWO_SIDED|95.0|-40.04|101.83|||t-test, 2 sided|||||101.83|-40.04|0.388
74015237|NCT04623242|147581447|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|6.624||0.909|TWO_SIDED|95.0|-13.97|12.45|||t-test, 2 sided|||||12.45|-13.97|0.909
74015238|NCT04623242|147581448|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.0593||0.004|TWO_SIDED|95.0|0.059|0.296|||t-test, 2 sided|||||0.296|0.059|0.004
74015239|NCT04623242|147581449|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.355||0.754|TWO_SIDED|95.0|-3.21|2.35|||t-test, 2 sided|||||2.35|-3.21|0.754
74044612|NCT00371540|147640973|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
74044613|NCT01548417|147640974|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Linear Mixed Effects Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in alcohol-cued craving..||||.003
74095311|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
74095312|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74095313|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74095314|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
74095315|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
74095316|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
74095317|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
74095318|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
74095319|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
74095320|NCT02912650|147740358|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
73880200|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|2.37||||0.2498|TWO_SIDED|95.0|0.55|10.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.25|0.55|0.2498
74095321|NCT02912650|147740359|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
74095322|NCT02912650|147740359|SUPERIORITY_OR_OTHER|||||||0.004|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||0.004
74095323|NCT02912650|147740359|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
74095324|NCT02912650|147740359|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
74095325|NCT02912650|147740359|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
74095326|NCT02912650|147740359|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||0.003
74095327|NCT01674647|147740371|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.15|1.73|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.02% (0.40% - 2.34%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||1.73|0.15|
74095328|NCT01674647|147740372|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.21|2.67|||no test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.26% - 1.27%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.80% (0.27% - 2.00%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||2.67|0.21|
74095329|NCT01674647|147740373|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.34|||||TWO_SIDED|95.0|0.06|2.0|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.20% (0.04% - 0.71%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||2.00|0.06|
74095330|NCT01674647|147740374|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.16|1.55|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.27% - 1.29%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.22% (0.53% - 2.51%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||1.55|0.16|
74044614|NCT01548417|147640975|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||Linear Mixed Effect Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in changes in drinking.||||.05
74044615|NCT01548417|147640975|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Data represent the estimated marginal mean + or - SEM. \*P\<0.05, mifepristone vs. placebo (linear mixed effects modeling).||||<0.05
73880201|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|8.22||||0.0576|TWO_SIDED|95.0|0.93|72.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||72.29|0.93|0.0576
73880202|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.34||||0.3065|TWO_SIDED|95.0|0.33|33.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||33.59|0.33|0.3065
73880203|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|19.9||||0.0056|TWO_SIDED|95.0|2.4|165.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||165.1|2.40|0.0056
74015240|NCT04623242|147581451|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|229362.3|STANDARD_ERROR_OF_MEAN|14863.08|<|0.001|TWO_SIDED|95.0|199264.32|259460.27|||t-test, 2 sided|||||259460.27|199264.32|<0.001
74044616|NCT01585168|147640976|OTHER||Mean Difference (Net)|2.4109||||0.032|TWO_SIDED|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided|A Paired t-test was performed to explore the difference between two groups.|FHN was found to have lower mean BOLD activation while given drug compared to placebo in amygdala.|||||0.032
74044617|NCT01585168|147640976|OTHER||Median Difference (Net)|3.6615||||0.125|TWO_SIDED||||||t-test, 2 sided|||||||0.125
74044618|NCT01585168|147640979|OTHER||Mean Difference (Net)|2.7264||||0.356|TWO_SIDED|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided||FHP was found to have lower mean BOLD activation while given drug compared to placebo in anterior cingulate cortex.|||||0.356
73880204|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|25.05||||0.0027|TWO_SIDED|95.0|3.05|205.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||205.5|3.05|0.0027
73880205|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.61||||0.2762|TWO_SIDED|95.0|0.36|36.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||36.51|0.36|0.2762
74044619|NCT01585168|147640979|OTHER||Median Difference (Net)|1.8348||||0.009|TWO_SIDED||||||t-test, 2 sided|||||||0.009
74044620|NCT03326583|147640999|SUPERIORITY|||||||0.05|||||||Fisher Exact|||||||.05
74044621|NCT03326583|147641000|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
73880206|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|6.93||||0.0851|TWO_SIDED|95.0|0.77|62.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||62.69|0.77|0.0851
73880207|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|17.02||||0.0081|TWO_SIDED|95.0|2.09|138.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||138.7|2.09|0.0081
74015241|NCT04623242|147581452|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|32906.6|STANDARD_ERROR_OF_MEAN|1697.541|<|0.001|TWO_SIDED|95.0|29406.49|36406.72|||t-test, 2 sided|||||36406.72|29406.49|<0.001
74015242|NCT04623242|147581453|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|1286.35|STANDARD_ERROR_OF_MEAN|140.692|<|0.001|TWO_SIDED|95.0|1002.79|1569.9|||t-test, 2 sided|||||1569.90|1002.79|<0.001
74044622|NCT03326583|147641001|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
74044623|NCT03326583|147641002|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
74044624|NCT01451398|147641060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.57|-0.23|||Mixed Models Analysis|Change in HbA1c = Baseline HbA1c + Region + Pooled OAD Strata + Visit + Treatment + (Treatment\*Visit), using AR(1) variance/covariance structure.||||-0.23|-0.57|<0.0001
74044625|NCT01451398|147641061|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.726||||0.0005|TWO_SIDED|95.0|1.55|4.8|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c||||4.80|1.55|0.0005
74044626|NCT01451398|147641062|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.361||||0.0021|TWO_SIDED|95.0|1.7|11.17|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c||||11.17|1.70|0.0021
74044627|NCT01451398|147641063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.42|STANDARD_ERROR_OF_MEAN|5.4||0.1698|TWO_SIDED|95.0|-18.03|3.18|||Mixed Models Analysis|"Model: FPG = Baseline FPG + Region + Pooled OAD Stratum + Visit + Treatment + (Treatment \* Visit)~Variance/Covariance Matrix is Autoregression 1"||||3.18|-18.03|0.1698
74044628|NCT01451398|147641066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.018|||TWO_SIDED|95.0|-0.12|-0.05|||Mixed Models Analysis|FEV1 = Baseline FEV1 + Age + Gender + Race + Height + Visit + Treatment + (Treatment\*Visit)||||-0.05|-0.12|
74044629|NCT01451398|147641069|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Negative binomial regression|Model: Treatment + Region + OAD Stratum + Exposure Time||||||<0.0001
73880208|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|6.37||||0.0995|TWO_SIDED|95.0|0.7|57.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||57.62|0.70|0.0995
74015243|NCT04623242|147581454|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|9867.26|STANDARD_ERROR_OF_MEAN|1212.232|<|0.001|TWO_SIDED|95.0|7419.38|12315.15|||t-test, 2 sided|||||12315.15|7419.38|<0.001
74015244|NCT00493870|147581473|OTHER|||||||0.05|||||||Log Rank|||||||0.05
74015245|NCT01289015|147581483|SUPERIORITY_OR_OTHER||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification was used to compare subjects with complete cure between NAFT-600 and placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1\<=p0 versus Ha (alternate): p1\>p0, where p0 and p1 are the proportions of subjects with complete cure in the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."||||<0.025
74015246|NCT01709149|147581487|SUPERIORITY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.366||0.114|TWO_SIDED|95.0|-1.3|0.14|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||0.14|-1.30|0.1140
74015247|NCT01709149|147581488|SUPERIORITY||Least squares mean difference|0.48|STANDARD_ERROR_OF_MEAN|1.963||0.8083|TWO_SIDED|95.0|-3.38|4.34|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||4.34|-3.38|0.8083
74015248|NCT01709149|147581489|SUPERIORITY||Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.627||0.0372|TWO_SIDED|95.0|-6.6|-0.2|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||-0.20|-6.60|0.0372
74015249|NCT01709149|147581490|SUPERIORITY||Least squares mean difference|4.25|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|2.23|6.28|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||6.28|2.23|<0.0001
74015250|NCT01709149|147581491|SUPERIORITY||Least squares mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.956||0.4328|TWO_SIDED|95.0|-1.13|2.63|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||2.63|-1.13|0.4328
74044630|NCT01451398|147641070|SUPERIORITY_OR_OTHER|||||||0.2024|||||||Negative Binomial Regression|Model: Treatment + Region + OAD Stratum + Exposure Time||||||0.2024
73880209|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|5.76||||0.1184|TWO_SIDED|95.0|0.64|51.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||51.80|0.64|0.1184
74015251|NCT01709149|147581492|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|4.399||0.9546|TWO_SIDED|95.0|-8.4|8.9|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||8.90|-8.40|0.9546
74015252|NCT01709149|147581493|SUPERIORITY||Least squares mean difference|1.61|STANDARD_ERROR_OF_MEAN|3.207||0.6166|TWO_SIDED|95.0|-4.7|7.91|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||7.91|-4.70|0.6166
74015253|NCT00428974|147581494|SUPERIORITY|||||||0.031|||||||t-test, 1 sided|||12 weeks, 2mg CF101 vs. Placebo||||0.031
74015254|NCT00428974|147581495|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
74015255|NCT02797808|147581497|SUPERIORITY||||||<|0.0083||||||Independent-sample t tests were used to compare the RSFC metrics between groups at baseline and 12 weeks. Bonferroni correction was applied to the alpha level (2-tailed, p\<.05/6= .0083) for multiple testing.|ANOVA|||||||<0.0083
74015256|NCT03759665|147581510|SUPERIORITY||Hodges-Lehmann Estimator|0.75||||0.044|TWO_SIDED|90.0|0.0|1.5|||1-sided Wilcoxon signed-rank test|||||1.50|0.00|0.044
74015257|NCT03759665|147581512|SUPERIORITY||Hodges-Lehmann Estimator|0.13||||0.206|TWO_SIDED|90.0|-0.13|0.25|||1-sided Wilcoxon signed-rank test|||||0.25|-0.13|0.206
74015258|NCT03759665|147581515|SUPERIORITY||Hodges-Lehmann Estimator|0.0327||||0.21|TWO_SIDED|90.0|-0.0327|0.104|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||0.1040|-0.0327|0.210
74015259|NCT03759665|147581515|SUPERIORITY||Hodges-Lehmann Estimator|-0.0291||||0.212|TWO_SIDED|90.0|-0.0863|0.0262|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.0262|-0.0863|0.212
74015260|NCT03759665|147581516|SUPERIORITY||Hodges-Lehmann Estimator|-1.25|||<|0.001|TWO_SIDED|90.0|-1.75|-0.75|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||-0.75|-1.75|<0.001
74015261|NCT03759665|147581516|SUPERIORITY||Hodges-Lehmann Estimator|1.25||||0.001|TWO_SIDED|90.0|0.5|2.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||2.00|0.50|0.001
74015262|NCT03759665|147581518|SUPERIORITY||Hodges-Lehmann Estimator|-0.031||||0.02|TWO_SIDED|90.0|-0.063|0.0|||1-sided Wilcoxon signed-rank test|||Treatment with IB1001||0.000|-0.063|0.020
74015263|NCT03759665|147581518|SUPERIORITY||Hodges-Lehmann Estimator|0.042|||<|0.001|TWO_SIDED|90.0|0.021|0.063|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.063|0.021|<0.001
74015264|NCT03759665|147581519|SUPERIORITY||Hodges-Lehmann Estimator|3.0|||<|0.001|TWO_SIDED|90.0|3.0|3.5|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||3.5|3.0|<0.001
74015265|NCT03759665|147581519|SUPERIORITY||Hodges-Lehmann Estimator|5.0|||<|0.001|TWO_SIDED|90.0|4.5|5.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||5.0|4.5|<0.001
74044631|NCT01451398|147641073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|0.365|<|0.0001|TWO_SIDED|95.0|0.9|2.34|||ANCOVA||Model: Baseline Weight + Change in HbA1c at Week 24 + Region + OAD Stratum + Treatment|||2.34|0.90|<0.0001
74015266|NCT05098041|147581522|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90 percent (%) confidence intervals (CIs) for the Geometric Mean Ratio (GMR) of Cmax for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the natural-log (ln)-transformed Cmax.|Geometric Mean Ratio (%)|13.15|||||TWO_SIDED|90.0|9.73|17.79|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||17.79|9.73|
74015267|NCT05098041|147581523|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90% CIs for the GMR of AUC∞ for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.|Geometric Mean Ratio (%)|16.42|||||TWO_SIDED|90.0|12.53|21.5|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||21.50|12.53|
74015268|NCT05098041|147581524|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90% CIs for the GMR of AUClast for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.|Geometric Mean Ratio (%)|14.92|||||TWO_SIDED|90.0|11.94|18.64|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||18.64|11.94|
74015269|NCT05098041|147581525|OTHER||Median Difference (Final Values)|-0.117|||=|0.0791|TWO_SIDED|90.0|-0.202|0.0|||Wilcoxon Signed-Rank Test||Difference was calculated as (Soticlestat + Rifampin) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% CI was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.000|-0.202|=0.07910
74015270|NCT00797732|147581533|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||.17
74015271|NCT02275338|147581545|OTHER|||||||0.0055||||||The expected proportion of responders using Lanreotide was 50%, 1 sided test, 2.5% significance level alpha and power of 80% using Z-test for binomial proportion.|Binomial test|||One sided binomial test to compare percentage of responding subjects to theoretical proportion of 30%.||||0.0055
74015272|NCT01857869|147581557|OTHER||1-Relative Risk|86.7|||<|0.0001|TWO_SIDED|95.0|66.8|94.6||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100\*(1-Relative Risk \[RR\]).||94.6|66.8|<0.0001
74015273|NCT01857869|147581557|OTHER||1-Relative Risk|62.5||||0.0009|TWO_SIDED|95.0|29.4|80.1||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100\*(1-Relative Risk \[RR\]).||80.1|29.4|0.0009
74015274|NCT03988335|147581579|OTHER|The primary endpoints were first tested at alpha of 10% (2-sided). If the larger p-value was less than 10% (2-sided), both primary endpoints were to be declared statistically significant. If the larger p-value was greater than 10%, but the smaller p-value was less than 5% (2-sided), then the primary endpoint with the smaller p-value was to be declared statistically significant.||||||0.24|||||||Hochberg's method|||||||0.24
74015275|NCT03988335|147581580|OTHER|The primary endpoints were first tested at alpha of 10% (2-sided). If the larger p-value was less than 10% (2sided), both primary endpoints were to be declared statistically significant. If the larger p-value was greater than 10%, but the smaller p-value was less than 5% (2-sided), then the primary endpoint with the smaller p-value was to be declared statistically significant.||||||0.804|||||||Hochberg's method|||||||0.804
74015276|NCT03603496|147581599|SUPERIORITY||Risk Ratio (RR)|1.18||||0.19|TWO_SIDED|95.0|0.92|1.5|||Chi-squared||Comparing TTCM as numerator, QL as denominator (reference group)|Two-stage multiple imputation techniques were used to estimate the missing smoking outcomes. 1st stage: we imputed missing data from surveys. 2nd stage: we imputed missing data from biochemical sample collection. Null hypothesis was no difference between arms in biochemically-validated past 7-day abstinence from cigarettes and other conventional tobacco products at 6-months. Sample of 1350 (675/group) was planned to detect a 6.5% difference (23.0% vs. 16.5%) with 84% power and 2-sided p\<0.05.||1.50|0.92|.19
74015277|NCT03603496|147581600|SUPERIORITY||Risk Ratio (RR)|1.22||||0.002|TWO_SIDED|95.0|1.08|1.35|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.35|1.08|.002
74015278|NCT03603496|147581601|SUPERIORITY||Risk Ratio (RR)|1.23||||0.001|TWO_SIDED|95.0|1.09|1.37|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.37|1.09|.001
74044632|NCT02754661|147641078|NON_INFERIORITY|The non-inferiority margin (δ) is pre-defined to be 5% in this study. Posterior Probability was based on Bayesian analysis.|Posterior Probability Bayesian analysis|0.9999|||||TWO_SIDED||||||||Support the claim of statistical non-inferiority of CCE vs CTC|||||
74044633|NCT02754661|147641079|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.3732|||<|0.0001|TWO_SIDED|90.0|0.203|0.5434|||Farrington-Manning test||Based on Farrington-Manning Method|||0.5434|0.2030|<0.0001
74044634|NCT02754661|147641080|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|-0.026||||0.019|TWO_SIDED|90.0|-0.0847|0.0327|||Farrington-Manning test||Based on Farrington-Manning Method|||0.0327|-0.0847|0.0190
74044635|NCT02754661|147641081|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0023||||0.093|TWO_SIDED|90.0|-0.1249|0.1249|||Farrington-Manning test||Based on Farrington-Manning Method|||0.1249|-0.1249|0.0930
74044636|NCT02754661|147641082|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0607||||0.0034|TWO_SIDED|90.0|-0.0371|0.1585|||Farrington-Manning test||Based on Farrington-Manning Method|||0.1585|-0.0371|0.0034
74044637|NCT01000025|147641083|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.506|TWO_SIDED|95.0|0.83|1.21||Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.1-sied p-value.|Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.||The trial was designed to detect a 25% deduction in risk of death with PF-804 with 90% power using a 1-sided 2.5% level significance test. The sample size was estimated as 720 patients.||1.21|0.83|0.506
74015279|NCT03603496|147581602|SUPERIORITY||Risk Ratio (RR)|1.13||||0.079|TWO_SIDED|95.0|0.98|1.29|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.29|0.98|.079
74044638|NCT01000025|147641084|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.043|TWO_SIDED|95.0|0.61|1.03||1-sided p-value|Log Rank|Stratified by stratification factors at randomization except study center.||||1.03|0.61|0.043
74015280|NCT03603496|147581603|SUPERIORITY||Risk Ratio (RR)|1.32|||<|0.0001|TWO_SIDED|95.0|1.21|1.44|||Chi-squared|||Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.||1.44|1.21|<.0001
74015281|NCT03603496|147581604|SUPERIORITY||Risk Ratio (RR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.23|1.5|||Chi-squared|||Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.||1.50|1.23|<.0001
74015282|NCT03603496|147581605|SUPERIORITY||Risk Ratio (RR)|1.31||||0.033|TWO_SIDED|95.0|1.02|1.66|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.66|1.02|.033
74015283|NCT00774345|147581606|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.276|TWO_SIDED|95.0|0.61|1.15||The p-value is based on a stratified log-rank test.|Log Rank||Based on the stratified cox proportional hazards model comparing the hazard functions associated with the treatment groups.|||1.15|0.61|0.276
74015284|NCT00684788|147581673|SUPERIORITY||Odds Ratio (OR)|5.68|||=|0.008|TWO_SIDED|95.0|1.61|20.02|||General Estimating Equation (GEE)|||||20.02|1.61|=0.008
74015285|NCT00684788|147581674|SUPERIORITY|||||||0.0033|||||||t-test, 2 sided|||||||0.0033
74044639|NCT01000025|147641085|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.46|TWO_SIDED|95.0|0.67|1.44||1-sided pvalue|Log Rank|||||1.44|0.67|0.46
74015286|NCT00684788|147581677|SUPERIORITY||Odds Ratio (OR)|1.05||||0.939|TWO_SIDED|95.0|0.32|3.42|||General Estimating Equation (GEE)|||||3.42|0.32|0.939
74015287|NCT00684788|147581679|SUPERIORITY||Odds Ratio (OR)|1.074||||0.959|TWO_SIDED|95.0|0.071|16.245|||General Estimating Equation (GEE)|||||16.245|0.071|0.959
74015288|NCT00623428|147581680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4557|TWO_SIDED|95.0|0.45|1.43|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|"The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.~(second column)."|In order to detect an improvement in SVR rate across all strata equivalent to an odds ratio of 2 (i.e. an increase in SVR by 15 to 16 percentage points at a power of 80% and a two-sided significance level of 0.05, 160 patients per treatment group (320 patients in total) were required.||1.43|0.45|0.4557
74044640|NCT01000025|147641086|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.55|0.79|||Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.||||0.79|0.55|< 0.0001
74044641|NCT01000025|147641087|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.11||||0.001|TWO_SIDED|95.0|1.84|20.3|||Cochran-Mantel-Haenszel|||||20.3|1.84|0.001
74044642|NCT04423757|147641095|OTHER||Adjusted mean difference|3.38|STANDARD_ERROR_OF_MEAN|3.1||0.2796|TWO_SIDED|90.0|-1.81|8.56|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||8.56|-1.81|0.2796
74044643|NCT04423757|147641096|OTHER||Odds Ratio (OR)|0.276||||0.0468|TWO_SIDED|90.0|0.091|0.781|||Regression, Logistic||For the calculation of the odds ratio Placebo is taken as reference.|Logistic regression includes treatment as covariate.||0.781|0.091|0.0468
74095331|NCT01674647|147740379|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.18|5.47|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.41% (0.14% - 1.02%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.41% (0.07% - 1.41%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||5.47|0.18|
74095332|NCT01674647|147740380|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.2|3.49|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||3.49|0.20|
74015289|NCT00623428|147581681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0788|TWO_SIDED|95.0|0.33|1.06|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.06|0.33|0.0788
74015290|NCT00623428|147581682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.5654|TWO_SIDED|95.0|0.48|3.87|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||3.87|0.48|0.5654
74015291|NCT00623428|147581684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.1934|TWO_SIDED|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.21|0.38|0.1934
74015292|NCT00623428|147581685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.1934|TWO_SIDED|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.21|0.38|0.1934
74015293|NCT00852995|147581724|SUPERIORITY_OR_OTHER|||||||0.00028|TWO_SIDED||||||t-test, 2 sided|||||||0.00028
74015294|NCT00852995|147581724|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED||||||t-test, 2 sided|||||||0.0899
74015295|NCT00852995|147581724|SUPERIORITY_OR_OTHER|||||||0.1586|TWO_SIDED||||||t-test, 2 sided|||||||0.1586
74015296|NCT00852995|147581724|SUPERIORITY_OR_OTHER|||||||0.0295|TWO_SIDED||||||t-test, 2 sided|||||||0.0295
74015297|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED|||||Treatment Week 01|ANCOVA|||||||.037
74015298|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||Treatment Week 02|ANCOVA|||||||.064
74015299|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED|||||Treatment Week 03|ANCOVA|||||||.161
74015300|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Treatment Week 04|ANCOVA|||||||.39
74015301|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||Treatment Week 05|ANCOVA|||||||.079
74015302|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.069|TWO_SIDED|||||Treatment Week 06|ANCOVA|||||||.069
74015303|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Treatment Week 07|ANCOVA|||||||.026
74015304|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED|||||Treatment Week 08|ANCOVA|||||||.133
74015305|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|||||Treatment Week 09|ANCOVA|||||||.089
74015306|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED|||||Treatment Week 10|ANCOVA|||||||.057
74015307|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||Treatment Week 11|ANCOVA|||||||.127
74015308|NCT00852995|147581726|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED|||||Treatment Week 12|ANCOVA|||||||0.395
74015309|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.0133|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.0133
73880210|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|26.54||||0.0023|TWO_SIDED|95.0|3.23|218.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||218.3|3.23|0.0023
74015310|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.3839|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.3839
74015311|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.5721|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.5721
74015312|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.232|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.232
74015313|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.0787|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.0787
74015314|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.7919|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.7919
74015315|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.6881|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.6881
74015316|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.9832|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.9832
74015317|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.0466|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.0466
74015318|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.8435|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.8435
74015319|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.8743|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.8743
74015320|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.2884|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.2884
74015321|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.0387|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.0387
74015322|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.8461|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.8461
74015323|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.9574|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.9574
74015324|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.2994|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.2994
74015325|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.1024|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.1024
74015326|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.8759|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.8759
74015327|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.9008|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.9008
74015328|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.4618|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4618
74015329|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.2439|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.2439
74015330|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.749|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.749
74015331|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.3749|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.3749
74015332|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.015
74044644|NCT04423757|147641097|OTHER||Adjusted mean difference|1.35|STANDARD_ERROR_OF_MEAN|3.5||0.698|TWO_SIDED|90.0|-4.47|7.17|||Mixed Models Analysis||Difference calculated as BI - Placebo.|S-Anxiety scale - Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||7.17|-4.47|0.6980
74015333|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.0078
74015334|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.07
74015335|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.208
74015336|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.0413|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.0413
74015337|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.0054|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0054
74015338|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.2031|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.2031
74015339|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.0894|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0894
74015340|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.0288|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0288
74015341|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.6964|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.6964
74044645|NCT04423757|147641097|OTHER||Adjusted mean difference|3.54|STANDARD_ERROR_OF_MEAN|3.1||0.2589|TWO_SIDED|90.0|-1.67|8.76|||Mixed Models Analysis||Difference calculated as BI - Placebo.|T-Anxiety scale - Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||8.76|-1.67|0.2589
74044646|NCT04423757|147641098|OTHER||Adjusted mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.4||0.1863|TWO_SIDED|90.0|-0.13|1.15|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||1.15|-0.13|0.1863
74095333|NCT02980874|147740387|SUPERIORITY||Difference in percentages|-6.1||||0.187|TWO_SIDED|95.0|-15.2|3.0||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.||3.0|-15.2|0.187
74095334|NCT04188301|147740412|SUPERIORITY||Odds Ratio (OR)|1.41||||0.192|TWO_SIDED|95.0|0.84|2.38||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA for living female O. volvulus worms in nodules after treatment.||2.38|0.84|0.192
74015342|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.59
74015343|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.7146|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.7146
74015344|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.5008|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.5008
74015345|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.1235|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.1235
74015346|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.5488|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.5488
74015347|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.4343|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.4343
74015348|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.1114|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.1114
74015349|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.2119|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.2119
74015350|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.0194|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.0194
74015351|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.506|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.506
74015352|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.2317|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.2317
74015353|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.1144|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.1144
74015354|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.6786|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.6786
74015355|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.7735|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.7735
74015356|NCT00852995|147581727|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.758
74015357|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||Week 04|Cochran-Mantel-Haenszel|||||||0.017
74015358|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED|||||Week 04|Cochran-Mantel-Haenszel|||||||.041
74015359|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||Week 05|Cochran-Mantel-Haenszel|||||||.017
74015360|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Week 06|Cochran-Mantel-Haenszel|||||||.011
74015361|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||Week 07|Cochran-Mantel-Haenszel|||||||.014
74015362|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||Week 08|Cochran-Mantel-Haenszel|||||||.029
74015363|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||Week 09|Cochran-Mantel-Haenszel|||||||.021
74015364|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED|||||Week 10|Cochran-Mantel-Haenszel|||||||.041
74044647|NCT04423757|147641099|OTHER||Adjusted mean difference|0.65|STANDARD_ERROR_OF_MEAN|3.1||0.8326|TWO_SIDED|90.0|-4.46|5.76|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||5.76|-4.46|0.8326
73880211|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|19.09||||0.0062|TWO_SIDED|95.0|2.31|157.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||157.9|2.31|0.0062
73880212|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|7.49||||0.0695|TWO_SIDED|95.0|0.85|65.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||65.87|0.85|0.0695
73880213|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|8.64||||0.052|TWO_SIDED|95.0|0.98|75.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||75.98|0.98|0.0520
73880214|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|22.3||||0.0036|TWO_SIDED|95.0|2.75|180.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||180.6|2.75|0.0036
73880215|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0676|TWO_SIDED|95.0|0.89|24.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||24.23|0.89|0.0676
73880216|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|4.14||||0.0903|TWO_SIDED|95.0|0.8|21.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||21.38|0.80|0.0903
73880217|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|15.46||||0.0007|TWO_SIDED|95.0|3.18|75.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||75.14|3.18|0.0007
73880218|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|10.94||||0.0032|TWO_SIDED|95.0|2.22|53.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.77|2.22|0.0032
74015365|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.044|TWO_SIDED|||||Week 10|Cochran-Mantel-Haenszel|||||||.044
74015366|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||Week 11|Cochran-Mantel-Haenszel|||||||.013
74015367|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||Week 11|Cochran-Mantel-Haenszel|||||||.024
74015368|NCT00852995|147581728|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Week 12|Cochran-Mantel-Haenszel|||||||.027
74015369|NCT00852995|147581730|SUPERIORITY_OR_OTHER|||||||0.0211|TWO_SIDED|||||P-value for Kaplan-Meier Days to Closure|ANCOVA|||||||0.0211
74044648|NCT04423757|147641100|OTHER||Adjusted mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.4||0.5567|TWO_SIDED|90.0|-0.43|0.89|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||0.89|-0.43|0.5567
73880219|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.04||||0.2031|TWO_SIDED|95.0|0.55|16.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||16.85|0.55|0.2031
73880220|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|4.13||||0.0972|TWO_SIDED|95.0|0.77|22.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||22.10|0.77|0.0972
73880221|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|11.04||||0.0027|TWO_SIDED|95.0|2.3|53.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.06|2.30|0.0027
74015370|NCT00852995|147581730|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.83||||0.0212|TWO_SIDED|95.0|1.09|3.04|||Regression, Cox|||||3.04|1.09|.0212
74015371|NCT00852995|147581730|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||ANCOVA|||||||0.59
74015372|NCT00852995|147581730|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.53|TWO_SIDED|95.0|0.69|2.05||This is the P-value for the Cox Hazard Ratio|Regression, Cox|||||2.05|.69|0.53
74015373|NCT00852995|147581730|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||ANCOVA|Kaplan-Meier Days to Closure||||||0.26
74015374|NCT00852995|147581730|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.19|TWO_SIDED|95.0|0.84|2.44||This is the P-value for the Cox Proportional Hazard Ratio|Regression, Cox|||||2.44|0.84|0.19
74044649|NCT02709109|147641103|SUPERIORITY||Least Square (LS) mean difference|0.2||||0.8173|TWO_SIDED|95.0|-1.4|1.8|||Mixed-effects Model for Repeated Measure|||||1.8|-1.4|0.8173
74015375|NCT00852995|147581730|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||P-value for Kaplan Meier Days to Closure|ANCOVA|||||||0.10
74015376|NCT00852995|147581730|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.06|TWO_SIDED|95.0|0.97|2.77||P-value for Cox Proportional Hazard Ratio|Regression, Cox|||||2.77|0.97|0.06
74015377|NCT03784079|147581866|OTHER||Emax|-1.937|||||TWO_SIDED|95.0|-2.484|-1.389||||||||-1.389|-2.484|
74015378|NCT03784079|147581866|OTHER||EC50|7.094|||||TWO_SIDED|95.0|0.585|13.602||||||||13.602|0.585|
74015379|NCT03784079|147581866|OTHER||s2e|0.137|||||TWO_SIDED|95.0|0.062|0.212||||||||0.212|0.062|
74015380|NCT03784079|147581867|OTHER||Emax|-1.929|||||TWO_SIDED|95.0|-2.479|-1.379||||||||-1.379|-2.479|
74015381|NCT03784079|147581867|OTHER||EC50|0.446|||||TWO_SIDED|95.0|0.03|0.861||||||||0.861|0.030|
74015382|NCT03784079|147581867|OTHER||s2e|0.139|||||TWO_SIDED|95.0|0.063|0.216||||||||0.216|0.063|
74015383|NCT03784079|147581868|OTHER||Emax|-1.926|||||TWO_SIDED|95.0|-2.498|-1.354||||||||-1.354|-2.498|
74015384|NCT03784079|147581868|OTHER||EC50|0.197|||||TWO_SIDED|95.0|0.007|0.386||||||||0.386|0.007|
74015385|NCT03784079|147581868|OTHER||s2e|0.144|||||TWO_SIDED|95.0|0.065|0.222||||||||0.222|0.065|
74015386|NCT02049944|147581900|OTHER|we used t-test on the regression coefficient for the group indicator to test for differences in means categorical variables were evaluated using fisher's exact test of association linear regression for log transformed start adipose concentrations were calculated by dose specific group|Median Difference (Final Values)|80.0|||||TWO_SIDED|95.0|||||Fisher Exact|||To detect the number of subjects who obtained a minimal inhibitory concentration (\>4mg/ml) following increased 3g dose of cefazolin. Compare this number to the historical cohort who had received 2g of cefazolin (standard dosing)||||
74095335|NCT04188301|147740412|SUPERIORITY||Odds Ratio (OR)|1.45||||0.107|TWO_SIDED|95.0|0.92|2.29||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for living female O. volvulus worms in nodules after treatment.||2.29|0.92|0.107
74095336|NCT04188301|147740412|SUPERIORITY|IA vs IDA treatment groups for living female O. volvulus worms in nodules after treatment.|Odds Ratio (OR)|1.44||||0.068|TWO_SIDED|95.0|0.97|2.15||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||||2.15|0.97|0.068
74095337|NCT04188301|147740412|SUPERIORITY||Odds Ratio (OR)|1.03||||0.918|TWO_SIDED|95.0|0.59|1.79||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA vs IDA3 for living female O. volvulus worms in nodules after treatment.||1.79|0.59|0.918
73888037|NCT01746901|147309532|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.8668|TWO_SIDED|95.0|-10.3|8.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.7|-10.3|0.8668
74015387|NCT01408147|147581901|SUPERIORITY||Mean Difference (Final Values)|2.3|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||To test the primary hypothesis, a generalized linear mixed effect model was used (intervention group as a fixed effect and clinic and subject as random effects). A group x time interaction term (fixed effect) tested if the change in weight over time differed significantly. The model included participant-level covariates (i.e., ethnicity, weeks postpartum at study entry, lactation, and age).||||<0.0001
74015388|NCT01765673|147581903|OTHER|||||||0.218|||||||paired t test|||||||0.218
74015389|NCT01765673|147581904|OTHER|||||||0.017|||||||paired t test|||||||0.017
74015390|NCT01765673|147581905|OTHER|||||||0.022|||||||paired t test|||||||0.022
74015391|NCT01765673|147581906|OTHER|||||||0.719|||||||paired t test|||||||0.719
74015392|NCT01765673|147581907|OTHER|||||||0.418|||||||paired t test|||||||0.418
74015393|NCT01765673|147581908|OTHER|||||||0.038|||||||paired t test|||||||0.038
74015394|NCT01765673|147581909|OTHER|||||||0.086|||||||paired t test|||||||0.086
74015395|NCT01765673|147581910|OTHER|||||||0.16|||||||paired t test|||||||0.16
74015396|NCT01765673|147581911|OTHER|||||||0.052|||||||paired t test|||||||0.052
74015397|NCT01765673|147581912|OTHER|||||||0.827|||||||paired t test|||||||0.827
74015398|NCT01765673|147581913|OTHER|||||||0.088|||||||paired t test|||||||0.088
74015399|NCT01765673|147581914|OTHER|||||||0.152|||||||paired t test|||||||0.152
74015400|NCT01765673|147581915|OTHER|||||||0.229|||||||paired t test|||||||0.229
74015401|NCT01765673|147581916|OTHER|||||||0.121|||||||paired t test|||||||0.121
74015402|NCT01765673|147581917|OTHER|||||||0.239|||||||paired t test|||||||0.239
74015403|NCT01765673|147581918|OTHER|||||||0.03|||||||paired t test|||||||0.03
74015404|NCT01765673|147581919|OTHER|||||||0.067|||||||paired t test|||||||0.067
74015405|NCT01765673|147581920|OTHER|||||||0.396|||||||paired t test|||||||0.396
74015406|NCT01765673|147581921|OTHER|||||||0.373|||||||paired t test|||||||0.373
74015407|NCT01765673|147581922|OTHER|||||||0.744|||||||paired t test|||||||0.744
74015408|NCT05048719|147581931|SUPERIORITY||LS Mean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.13|-0.4|||Mixed Models Analysis|||||-0.40|-1.13|<0.001
74015409|NCT05048719|147581931|SUPERIORITY||LS Mean Difference|-1.49|||<|0.001|TWO_SIDED|95.0|-1.85|-1.12|||Mixed Models Analysis|||||-1.12|-1.85|<0.001
74015410|NCT05048719|147581931|SUPERIORITY||LS Mean Difference|-1.36|||<|0.001|TWO_SIDED|95.0|-1.75|-0.98|||Mixed Models Analysis|||||-0.98|-1.75|<0.001
74015411|NCT05048719|147581931|SUPERIORITY||LS Mean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-1.96|-1.25|||Mixed Models Analysis|||||-1.25|-1.96|<0.001
74015412|NCT05048719|147581931|SUPERIORITY||LS Mean Difference|-1.67|||<|0.001|TWO_SIDED|95.0|-2.02|-1.32|||Mixed Models Analysis|||||-1.32|-2.02|<0.001
74015413|NCT05048719|147581932|SUPERIORITY||LS Mean Difference|-0.09||||0.626|TWO_SIDED|95.0|-0.47|0.28|||Mixed Models Analysis|||||0.28|-0.47|0.626
74015414|NCT05048719|147581932|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.18|-0.44|||Mixed Models Analysis|||||-0.44|-1.18|<0.001
74015415|NCT05048719|147581932|SUPERIORITY||LS Mean Difference|-0.69|||<|0.001|TWO_SIDED|95.0|-1.08|-0.3|||Mixed Models Analysis|||||-0.30|-1.08|<0.001
74015416|NCT05048719|147581932|SUPERIORITY||LS Mean Difference|-0.93|||<|0.001|TWO_SIDED|95.0|-1.29|-0.57|||Mixed Models Analysis|||||-0.57|-1.29|<0.001
73880222|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.06||||0.1306|TWO_SIDED|95.0|0.72|13.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.02|0.72|0.1306
73880223|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|4.83||||0.0248|TWO_SIDED|95.0|1.22|19.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||19.10|1.22|0.0248
74015417|NCT05048719|147581932|SUPERIORITY||LS Mean Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-1.36|-0.64|||Mixed Models Analysis|||||-0.64|-1.36|<0.001
73880224|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|7.14||||0.0054|TWO_SIDED|95.0|1.79|28.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||28.53|1.79|0.0054
74015418|NCT05048719|147581933|OTHER||Odds Ratio (OR)|6.77|||<|0.001|TWO_SIDED|95.0|2.21|20.75|||Regression, Logistic|||||20.75|2.21|<0.001
74015419|NCT05048719|147581933|OTHER||Odds Ratio (OR)|34.09|||<|0.001|TWO_SIDED|95.0|9.92|117.16|||Regression, Logistic|||||117.16|9.92|<0.001
74015420|NCT05048719|147581933|OTHER||Odds Ratio (OR)|48.33|||<|0.001|TWO_SIDED|95.0|11.9|196.24|||Regression, Logistic|||||196.24|11.90|<0.001
74015421|NCT05048719|147581933|OTHER||Odds Ratio (OR)|45.72|||<|0.001|TWO_SIDED|95.0|13.61|153.64|||Regression, Logistic|||||153.64|13.61|<0.001
74095338|NCT04188301|147740415|SUPERIORITY||Odds Ratio (OR)|1.41||||0.192|TWO_SIDED|95.0|0.84|2.38||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA for living female O. volvulus worms in nodules after treatment.||2.38|0.84|0.192
74015422|NCT05048719|147581933|OTHER||Odds Ratio (OR)|77.23|||<|0.001|TWO_SIDED|95.0|20.26|294.48|||Regression, Logistic|||||294.48|20.26|<0.001
74015423|NCT05048719|147581933|OTHER||Odds Ratio (OR)|1.22||||0.678|TWO_SIDED|95.0|0.48|3.13|||Regression, Logistic|||||3.13|0.48|0.678
74015424|NCT05048719|147581933|OTHER||Odds Ratio (OR)|6.15|||<|0.001|TWO_SIDED|95.0|2.19|17.24|||Regression, Logistic|||||17.24|2.19|<0.001
74015425|NCT05048719|147581933|OTHER||Odds Ratio (OR)|8.71|||<|0.001|TWO_SIDED|95.0|2.55|29.79|||Regression, Logistic|||||29.79|2.55|<0.001
73880225|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|10.01||||0.001|TWO_SIDED|95.0|2.55|39.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||39.36|2.55|0.0010
74015426|NCT05048719|147581933|OTHER||Odds Ratio (OR)|8.24|||<|0.001|TWO_SIDED|95.0|3.05|22.3|||Regression, Logistic|||||22.30|3.05|<0.001
74015427|NCT05048719|147581933|OTHER||Odds Ratio (OR)|13.93|||<|0.001|TWO_SIDED|95.0|4.51|43.01|||Regression, Logistic|||||43.01|4.51|<0.001
74015428|NCT05048719|147581934|OTHER||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|95.0|2.93|22.9|||Regression, Logistic|||||22.90|2.93|<0.001
74015429|NCT05048719|147581934|OTHER||Odds Ratio (OR)|25.02|||<|0.001|TWO_SIDED|95.0|7.57|82.69|||Regression, Logistic|||||82.69|7.57|<0.001
74015430|NCT05048719|147581934|OTHER||Odds Ratio (OR)|62.31|||<|0.001|TWO_SIDED|95.0|12.26|316.63|||Regression, Logistic|||||316.63|12.26|<0.001
74015431|NCT05048719|147581934|OTHER||Odds Ratio (OR)|67.57|||<|0.001|TWO_SIDED|95.0|17.56|259.97|||Regression, Logistic|||||259.97|17.56|<0.001
74015432|NCT05048719|147581934|OTHER||Odds Ratio (OR)|129.55|||<|0.001|TWO_SIDED|95.0|26.72|628.09|||Regression, Logistic|||||628.09|26.72|<0.001
74015433|NCT05048719|147581934|OTHER||Odds Ratio (OR)|1.13||||0.802|TWO_SIDED|95.0|0.43|2.96|||Regression, Logistic|||||2.96|0.43|0.802
74015434|NCT05048719|147581934|OTHER||Odds Ratio (OR)|3.46||||0.026|TWO_SIDED|95.0|1.16|10.31|||Regression, Logistic|||||10.31|1.16|0.026
74015435|NCT05048719|147581934|OTHER||Odds Ratio (OR)|8.61||||0.006|TWO_SIDED|95.0|1.83|40.51|||Regression, Logistic|||||40.51|1.83|0.006
74015436|NCT05048719|147581934|OTHER||Odds Ratio (OR)|9.34|||<|0.001|TWO_SIDED|95.0|2.67|32.71|||Regression, Logistic|||||32.71|2.67|<0.001
74015437|NCT05048719|147581934|OTHER||Odds Ratio (OR)|17.9|||<|0.001|TWO_SIDED|95.0|4.02|79.7|||Regression, Logistic|||||79.70|4.02|<0.001
74015438|NCT05048719|147581935|OTHER||LS Mean Difference|-21.5|||<|0.001|TWO_SIDED|95.0|-32.7|-10.3|||Mixed Models Analysis|||||-10.3|-32.7|<0.001
74015439|NCT05048719|147581935|OTHER||LS Mean Difference|-42.5|||<|0.001|TWO_SIDED|95.0|-53.4|-31.7|||Mixed Models Analysis|||||-31.7|-53.4|<0.001
74015440|NCT05048719|147581935|OTHER||LS Mean Difference|-41.0|||<|0.001|TWO_SIDED|95.0|-52.7|-29.3|||Mixed Models Analysis|||||-29.3|-52.7|<0.001
74015441|NCT05048719|147581935|OTHER||LS Mean Difference|-42.7|||<|0.001|TWO_SIDED|95.0|-53.5|-32.0|||Mixed Models Analysis|||||-32.0|-53.5|<0.001
74015442|NCT05048719|147581935|OTHER||LS Mean Difference|-44.7|||<|0.001|TWO_SIDED|95.0|-55.3|-34.2|||Mixed Models Analysis|||||-34.2|-55.3|<0.001
74015443|NCT05048719|147581935|OTHER||LS Mean Difference|0.6|||<|0.001|TWO_SIDED|95.0|-10.6|11.8|||Mixed Models Analysis|||||11.8|-10.6|<0.001
74015444|NCT05048719|147581935|OTHER||LS Mean Difference|-20.5|||<|0.001|TWO_SIDED|95.0|-31.4|-9.5|||Mixed Models Analysis|||||-9.5|-31.4|<0.001
74015445|NCT05048719|147581935|OTHER||LS Mean Difference|-19.0||||0.002|TWO_SIDED|95.0|-30.7|-7.2|||Mixed Models Analysis|||||-7.2|-30.7|0.002
74015446|NCT05048719|147581935|OTHER||LS Mean Difference|-20.7|||<|0.001|TWO_SIDED|95.0|-31.4|-9.9|||Mixed Models Analysis|||||-9.9|-31.4|<0.001
74015447|NCT05048719|147581935|OTHER||LS Mean Difference|-22.7|||<|0.001|TWO_SIDED|95.0|-33.2|-12.1|||Mixed Models Analysis|||||-12.1|-33.2|<0.001
74015448|NCT05048719|147581936|OTHER||LS Mean Difference|-1.6||||0.153|TWO_SIDED|95.0|-3.7|0.6|||Mixed Models Analysis|||||0.6|-3.7|0.153
74015449|NCT05048719|147581936|OTHER||LS Mean Difference|-4.3|||<|0.001|TWO_SIDED|95.0|-6.4|-2.2|||Mixed Models Analysis|||||-2.2|-6.4|<0.001
74015450|NCT05048719|147581936|OTHER||LS Mean Difference|-7.6|||<|0.001|TWO_SIDED|95.0|-9.8|-5.3|||Mixed Models Analysis|||||-5.3|-9.8|<0.001
73880226|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8271|TWO_SIDED|95.0|0.23|6.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.45|0.23|0.8271
73880227|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.27||||0.1089|TWO_SIDED|95.0|0.77|13.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.95|0.77|0.1089
74015451|NCT05048719|147581936|OTHER||LS Mean Difference|-7.4|||<|0.001|TWO_SIDED|95.0|-9.4|-5.3|||Mixed Models Analysis|||||-5.3|-9.4|<0.001
74015452|NCT05048719|147581936|OTHER||LS Mean Difference|-7.9|||<|0.001|TWO_SIDED|95.0|-9.9|-5.9|||Mixed Models Analysis|||||-5.9|-9.9|<0.001
74015453|NCT05048719|147581936|OTHER||LS Mean Difference|0.1||||0.914|TWO_SIDED|95.0|-2.0|2.3|||Mixed Models Analysis|||||2.3|-2.0|0.914
74015454|NCT05048719|147581936|OTHER||LS Mean Difference|-2.6||||0.015|TWO_SIDED|95.0|-4.7|-0.5|||Mixed Models Analysis|||||-0.5|-4.7|0.015
74015455|NCT05048719|147581936|OTHER||LS Mean Difference|-5.9|||<|0.001|TWO_SIDED|95.0|-8.1|-3.6|||Mixed Models Analysis|||||-3.6|-8.1|<0.001
74015456|NCT05048719|147581936|OTHER||LS Mean Difference|-5.7|||<|0.001|TWO_SIDED|95.0|-7.8|-3.6|||Mixed Models Analysis|||||-3.6|-7.8|<0.001
74015457|NCT05048719|147581936|OTHER||LS Mean Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-8.3|-4.2|||Mixed Models Analysis|||||-4.2|-8.3|<0.001
74015458|NCT03325673|147581973|SUPERIORITY|||||||0.116|||||||Independent t-test|||||||0.116
74015459|NCT03325673|147581974|SUPERIORITY|||||||0.468|||||||t-test, 2 sided|||Insertion||||0.468
74015460|NCT03325673|147581974|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||After 2 hours||||0.235
74015461|NCT03325673|147581974|SUPERIORITY|||||||0.152|||||||t-test, 2 sided|||End of Day||||0.152
74015462|NCT03325673|147581975|SUPERIORITY|||||||0.488|||||||t-test, 2 sided|||||||0.488
74015463|NCT03325673|147581976|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||0.072
74015464|NCT00590590|147581977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||||||||||Ha: Drug 1 \< Drug 2||||
74015465|NCT00590590|147581977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 \< Placebo||||
74015466|NCT00590590|147581977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 2 \< Placebo||||
74015467|NCT00590590|147581978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||||||||||||Ha: Drug 1 \< Drug 2||||
74015468|NCT00590590|147581978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 \< Placebo||||
74015469|NCT00590590|147581978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||||||||||||Ha: Drug 2 \< Placebo||||
74015470|NCT00590590|147581979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||||||||||||Ha: Drug 1 \< Drug 2||||
74015471|NCT00590590|147581979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||||||||||||Ha: Drug 1 \< Placebo||||
73880228|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|5.58||||0.0138|TWO_SIDED|95.0|1.42|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||21.93|1.42|0.0138
74015472|NCT00590590|147581979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8||||||||||||||Ha: Drug 2 \< Placebo||||
74015473|NCT00590590|147581980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3||||||||||||||Ha: Drug 1 \< Drug 2||||
74015474|NCT00590590|147581980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.0||||||||||||||Ha: Drug 1 \< Placebo||||
74015475|NCT00590590|147581980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||||||||||||Ha: Drug 2 \< Placebo||||
74015476|NCT00590590|147581981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||||||||||||Ha: Drug 1 \< Drug 2||||
74015477|NCT00590590|147581981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||||||||||||Ha: Drug 1 \< Placebo||||
74015478|NCT00590590|147581981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0||||||||||||||Ha: Drug 2 \< Placebo||||
74015479|NCT00590590|147581982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||||||||||||Ha: Drug 1 \< Drug 2||||
74015480|NCT00590590|147581982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||||||||||||Ha: Drug 1 \< Placebo||||
74015481|NCT00590590|147581982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||||||||||||Ha: Drug 2 \< Placebo||||
74015482|NCT00132132|147581989|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|This analysis is the per protocol unadjusted value||||||0.03
74015483|NCT00132132|147581989|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|Age adjusted per protocol||||||0.14
74015484|NCT00132132|147581989|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||t-test, 2 sided|Per protocol adjusted for age and paternal education. Given the small number of participants with complete data, this model may be overfit.||||||0.006
74015485|NCT00132132|147581990|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
74015486|NCT02025426|147581991|OTHER|||||||0.547|||||||Kruskal-Wallis|||||||0.547
74015487|NCT02025426|147581993|OTHER|||||||0.925|||||||Kruskal-Wallis|||||||0.925
74015488|NCT02025426|147581994|OTHER|||||||0.498|||||||Kruskal-Wallis|||||||0.498
74015489|NCT02025426|147581995|OTHER|||||||0.201|||||||Kruskal-Wallis|||||||0.201
74015490|NCT02025426|147581996|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
74015491|NCT02025426|147581997|OTHER|||||||0.962|||||||Fisher Exact|||||||0.962
74015492|NCT02025426|147581998|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
74015493|NCT01602692|147582001|OTHER|||||||0.24|||||||ANOVA|||End of PACU Mean Pain Level p-value between arms||||0.24
74015494|NCT01602692|147582001|OTHER|||||||0.76|||||||ANOVA|||First 24 hrs Post-op Mean Current Pain p-value between arms||||0.76
74015495|NCT01602692|147582001|OTHER|||||||0.78|||||||ANOVA|||First 24 hrs Post-op Mean Worst Pain p-value between arms||||0.78
74015496|NCT01602692|147582001|OTHER|||||||0.41|||||||ANOVA|||First 24 hrs Post-op Mean Least Pain p-value between arms||||0.41
74015497|NCT01602692|147582002|OTHER|||||||0.1|||||||ANOVA|||PACU IV hydromorphone p-value between arms||||0.10
74015498|NCT01602692|147582002|OTHER|||||||0.71|||||||ANOVA|||First 24 hr Post-op oxycodone p-value between arms||||0.71
74044650|NCT02709109|147641103|SUPERIORITY||LS mean difference|-0.7||||0.5903|TWO_SIDED|95.0|-3.3|1.9|||Mixed-effects Model for Repeated Measure|||||1.9|-3.3|0.5903
74015499|NCT00527605|147582028|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-14.23|||<|0.0001||95.0|-20.23|-8.22|||t-test, 2 sided||Dutasteride arm minus placebo arm.|||-8.22|-20.23|<0.0001
74015500|NCT01008280|147582074|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinking days.||||<0.01
74015501|NCT01008280|147582074|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinking days.||||>0.01
74044651|NCT02709109|147641103|SUPERIORITY||LS mean difference|-0.7||||0.5917|TWO_SIDED|95.0|-3.4|1.9|||Mixed-effects Model for Repeated Measure|||||1.9|-3.4|0.5917
74044652|NCT02709109|147641103|SUPERIORITY||LS mean difference|-0.9||||0.5021|TWO_SIDED|95.0|-3.6|1.8|||Mixed-effects Model for Repeated Measure|||||1.8|-3.6|0.5021
74044653|NCT02709109|147641103|SUPERIORITY||LS mean difference|-1.6||||0.1382|TWO_SIDED|95.0|-3.8|0.5|||Mixed-effects Model for Repeated Measure|||||0.5|-3.8|0.1382
74044654|NCT02709109|147641103|SUPERIORITY||LS mean difference|0.9||||0.4962|TWO_SIDED|95.0|-1.7|3.5|||Mixed-effects Model for Repeated Measure|||||3.5|-1.7|0.4962
74044655|NCT02738580|147641106|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|0.26|<|0.05|TWO_SIDED|||||The proportion of patients with elevated Progesterone on last day of stimulation(\>1.5 ng/mL) was compared between both groups using the Chi-square test.|t-test, 2 sided|||||||<0.05
74044656|NCT02738580|147641107|SUPERIORITY||||||<|0.49|||||||t-test, 1 sided|||||||<0.49
74044657|NCT00996593|147641108|SUPERIORITY_OR_OTHER||Percentage of participants|65.0|||||TWO_SIDED|95.0|50.0|80.0|||||The estimated value represents the percentage of participants with complete response.|||80|50|
74095339|NCT04188301|147740415|SUPERIORITY||Odds Ratio (OR)|1.45||||0.107|TWO_SIDED|95.0|0.92|2.29||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for living female O. volvulus worms in nodules after treatment.||2.29|0.92|0.107
74044658|NCT00996593|147641109|SUPERIORITY_OR_OTHER||Percentage of participants|23.0|||||TWO_SIDED|95.0|10.0|35.0|||||The estimated value represents the percentage of participants with complete response.|||35|10|
74044659|NCT00996593|147641110|SUPERIORITY_OR_OTHER||Percentage of participants|38.0|||||TWO_SIDED|95.0|22.0|53.0|||||The estimated value represents the percentage of participants with complete response.|||53|22|
74095340|NCT04188301|147740415|SUPERIORITY||Odds Ratio (OR)|1.44||||0.068|TWO_SIDED|95.0|0.97|2.15||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA groups for living female O. volvulus worms in nodules after treatment.||2.15|0.97|0.068
74044660|NCT00996593|147641111|SUPERIORITY_OR_OTHER||Percentage of participants|28.0|||||TWO_SIDED|95.0|14.0|41.0|||||The estimated value represents the percentage of participants with complete response.|||41|14|
74044661|NCT00996593|147641116|SUPERIORITY_OR_OTHER||Percentage of responders|75.0||||1|TWO_SIDED|95.0|54.0|96.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||96|54|1.0
74044662|NCT00996593|147641116|SUPERIORITY_OR_OTHER||Percentage of responders|70.0||||1|TWO_SIDED|95.0|51.0|88.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||88|51|1.0
74044663|NCT00996593|147641117|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Fisher Exact|||||||0.8
74044664|NCT00996593|147641118|SUPERIORITY_OR_OTHER||Percentage of responders|31.0||||1|TWO_SIDED|95.0|9.0|54.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||54|9|1.0
74044665|NCT00996593|147641118|SUPERIORITY_OR_OTHER||Percentage of responders|17.0||||1|TWO_SIDED|95.0|2.0|33.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||33|2|1.0
74044666|NCT00996593|147641119|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
74044667|NCT00996593|147641120|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Log Rank|||||||0.9
74044668|NCT03920865|147641133|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.802|||||TWO_SIDED|90.0|0.627|1.03||||||||1.03|0.627|
74015502|NCT01008280|147582074|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time by group effects for the number of drinking days.||||>0.01
74044669|NCT03920865|147641133|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.842|||||TWO_SIDED|90.0|0.588|1.21||||||||1.21|0.588|
74044670|NCT03920865|147641135|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.95|||||TWO_SIDED|90.0|0.695|1.3||||||||1.30|0.695|
74044671|NCT03920865|147641135|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.953|||||TWO_SIDED|90.0|0.715|1.27||||||||1.27|0.715|
74044672|NCT03920865|147641136|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|0.83|1.39||||||||1.39|0.830|
74044673|NCT03920865|147641136|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.947|||||TWO_SIDED|90.0|0.74|1.21||||||||1.21|0.740|
74044674|NCT03920865|147641138|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|1.2|||||TWO_SIDED|90.0|0.962|1.49||||||||1.49|0.962|
74044675|NCT03920865|147641138|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.991|||||TWO_SIDED|90.0|0.81|1.21||||||||1.21|0.810|
74044676|NCT05563714|147641173|SUPERIORITY||Odds Ratio (OR)|5.22|||<|0.001|TWO_SIDED|95.0|2.41|11.33|||generalized linear mixed effects model||Adjusted OR (base model)|Adjusted OR (base model), 95% CI - Includes clinician proceduralist vs non-proceduralist status as a co-variate.||11.33|2.41|<0.001
73880229|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1987|TWO_SIDED|95.0|0.63|9.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.15|0.63|0.1987
73880230|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3984|TWO_SIDED|95.0|0.46|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.02|0.46|0.3984
73880231|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0402|TWO_SIDED|95.0|1.06|14.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||14.45|1.06|0.0402
73880232|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|8.05||||0.001|TWO_SIDED|95.0|2.32|27.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||27.95|2.32|0.0010
74015503|NCT01008280|147582075|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinks.||||<0.01
74015504|NCT01008280|147582075|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinks.||||>0.01
74015505|NCT01008280|147582075|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of drinks.||||>0.01
74015506|NCT01008280|147582076|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of heavy drinking days.||||<0.01
74015507|NCT01008280|147582076|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of heavy drinking days.||||>0.01
74015508|NCT01008280|147582076|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of heavy drinking days.||||>0.01
74015509|NCT01968460|147582077|SUPERIORITY||Mean Difference (Net)|-4.67|STANDARD_ERROR_OF_MEAN|1.28||0.0004|TWO_SIDED|95.0|-7.2|-2.13||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-2.13|-7.20|0.0004
74044677|NCT05563714|147641173|SUPERIORITY||Odds Ratio (OR)|5.76|||<|0.001|TWO_SIDED|95.0|2.54|13.05|||generalized linear mixed effects model||Adjusted OR (expanded model)|Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.||13.05|2.54|<0.001
74044678|NCT05563714|147641174|SUPERIORITY||Odds Ratio (OR)|29.3|||<|0.001|TWO_SIDED|95.0|6.07|141.49|||generalized linear mixed effects model||Adjusted OR (base model)|Adjusted OR (base model), 95% CI - Included clinician proceduralist vs non-proceduralist status as a co-variate.||141.49|6.07|<0.001
74044679|NCT05563714|147641174|SUPERIORITY||Odds Ratio (OR)|43.6|||<|0.001|TWO_SIDED|95.0|6.56|289.88|||generalized linear mixed effects model||Adjusted OR (expanded model)|Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.||289.88|6.56|<0.001
73880233|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8287|TWO_SIDED|95.0|0.17|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.08|0.17|0.8287
74015510|NCT01968460|147582077|SUPERIORITY||Mean Difference (Net)|-3.84|STANDARD_ERROR_OF_MEAN|1.25||0.0027|TWO_SIDED|95.0|-6.32|-1.36||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-1.36|-6.32|0.0027
74015511|NCT01968460|147582078|SUPERIORITY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|0.51||0.0004|TWO_SIDED|95.0|-2.86|-0.84||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.84|-2.86|0.0004
74015512|NCT01968460|147582078|SUPERIORITY||Mean Difference (Net)|-1.42|STANDARD_ERROR_OF_MEAN|0.01||0.005|TWO_SIDED|95.0|-2.41|0.44||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||0.44|-2.41|0.005
74095341|NCT04188301|147740415|SUPERIORITY||Odds Ratio (OR)|1.03||||0.918|TWO_SIDED|95.0|0.59|1.79||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA vs IDA3 for living female O. volvulus worms in nodules after treatment.||1.79|0.59|0.918
74095342|NCT04188301|147740418|SUPERIORITY||Odds Ratio (OR)|1.66||||0.134|TWO_SIDED|95.0|0.85|3.21||Adjusted p values were model-adjusted for repeated measurements per person. Participant level random effects were included in the model to adjust for multiple worms/person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA in fertile female O. volvulus worms in nodules after treatment.||3.21|0.85|0.134
74095343|NCT04188301|147740418|SUPERIORITY||Odds Ratio (OR)|2.23||||0.023|TWO_SIDED|95.0|1.12|4.44||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for fertile female O. volvulus worms in nodules after treatment.||4.44|1.12|0.023
74095344|NCT04188301|147740418|SUPERIORITY||Odds Ratio (OR)|1.32||||0.43|TWO_SIDED|95.0|0.64|2.85||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA1 vs IDA3 for fertile female O. volvulus worms in nodules after treatment.||2.85|.64|0.430
74095345|NCT04188301|147740418|SUPERIORITY||Odds Ratio (OR)|1.91||||0.023|TWO_SIDED|95.0|1.09|3.34||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA treatment groups for fertile female O. volvulus worms in nodules after treatment.||3.34|1.09|0.023
74095346|NCT04221789|147740430|OTHER|differences in proportions|Risk Ratio (RR)|1.12||||0.049|TWO_SIDED|95.0|1.02|1.2||Statistical significance threshold p \<0.05|Chi-squared|||Ho no difference in treatment success between groups. The study was originally powered to detect a 15% difference between groups||1.20|1.02|0.049
74095347|NCT04221789|147740431|OTHER|comparison of proportions and relative risk with 95% CI|Risk Ratio (RR)|0.7|||<|0.043|TWO_SIDED|95.0|0.5|0.97||statistical significance if p value \<0.05|Chi-squared||intervention / control|Ho No difference between arms. 80% power to detect a 10% difference||0.97|0.50|<0.043
74095348|NCT02906930|147740457|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.3|<0.0001
73880234|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|2.93||||0.1083|TWO_SIDED|95.0|0.79|10.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.92|0.79|0.1083
74044680|NCT05563714|147641175|SUPERIORITY|Adjusted OR, 95% CI (base model) - Included clinician proceduralist vs non-proceduralist status as a co-variate.|Odds Ratio, log|19.86|||<|0.001|TWO_SIDED|95.0|10.63|29.09|||generalized linear mixed effects model|||We used generalized linear mixed effects modeling (logit link) to estimate the odds of medication optimization at week 7-10. This model included fixed effects for CNNF (vs. usual care), target provider specialty and size, and a random effect for clinician to account for the clustering of patients. We report the log odds ratios with corresponding confidence intervals for the main effect. The main effect was tested at a two-sided 5% significance level.||29.09|10.63|<0.001
74044681|NCT01610206|147641181|EQUIVALENCE|To estimate the progression-free survival hazard ratio of the combination of weekly gemcitabine and pazopanib compared to weekly gemcitabine alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.|Hazard Ratio (HR)|0.81||||0.019|TWO_SIDED|95.0|0.61|1.07|||non-parametric weighted Tarone-Ware test|||||1.07|0.61|0.019
74044682|NCT00166517|147641183|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed versus a constant, 85%, based on historical data.||||||0.003||95.0||||p ≥.85, where p is the proportion of subjects who achieved ≥3-fold rise from baseline in the group that received RotaTeq®|Exact test of proportion|Exact test of proportion, based on binomial distribution||||||0.003
74044683|NCT03061812|147641194|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.0051|TWO_SIDED|95.0|1.17|1.82|||Log Rank|Two-sided p-value stratified by the randomization stratification factors.|Calculated using a Cox proportional hazards regression model, with treatment and randomization stratification factors as covariates.|||1.82|1.17|0.0051
74015513|NCT01968460|147582079|SUPERIORITY||Odds Ratio (OR)|8.1||||0.0165|TWO_SIDED|95.0|1.47|44.77||The overall significance level for this study was 5% using two-tailed tests.|Regression, Logistic|||A subject will be defined as a treatment responder in case that the improvement from baseline to the Week12 / Last Observed Value (LOV) in the CGI-S will be of 1 point or more. Baseline adjusted logistic regression (SAS® LOGISTIC procedure) stratified by GeoSite using the STRATA sub-command with the following effects: treatment group and baseline CGI-S measurement was used to test the between the active groups and placebo contrasts.||44.77|1.47|0.0165
74015514|NCT01968460|147582079|SUPERIORITY||Odds Ratio (OR)|4.23|STANDARD_ERROR_OF_MEAN|0.9||0.111|TWO_SIDED|95.0|0.72|24.9||The overall significance level for this study will be 5% using two-tailed tests.|Regression, Logistic|||||24.90|0.72|0.111
74015515|NCT01968460|147582080|SUPERIORITY||Mean Difference (Net)|-2.81|STANDARD_ERROR_OF_MEAN|1.0||0.0058|TWO_SIDED|95.0|-4.8|-0.83||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.83|-4.80|0.0058
74015516|NCT01968460|147582080|SUPERIORITY||Mean Difference (Net)|-2.32|STANDARD_ERROR_OF_MEAN|0.98||0.0191|TWO_SIDED|95.0|-4.26|-0.39||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.39|-4.26|0.0191
74015517|NCT01968460|147582081|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.24||0.0097|TWO_SIDED|95.0|-5.72|-0.8||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|Mixed Models Analysis|||||-0.80|-5.72|0.0097
74015518|NCT01968460|147582081|SUPERIORITY||Mean Difference (Net)|-2.45|STANDARD_ERROR_OF_MEAN|1.24||0.0509|TWO_SIDED|95.0|-4.91|-0.012||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|Mixed Models Analysis|||||-0.012|-4.91|0.0509
74015519|NCT00179309|147582100|SUPERIORITY_OR_OTHER|||||||0.12|ONE_SIDED|95.0||||Multiple comparisons were not done.|Log Rank|||48 evaluable pts will be randomized in a 1:1 ratio between two arms (24 evaluable pts per arm). Using standard formulae (e.g. nQuery Advisor v5), this number was selected to provide 80% power to detect a difference between 4.2 month median progression free survival (PFS) on the docetaxel alone arm and 8 month median PFS on the arm receiving PANVAC plus docetaxel, with a one-tailed alpha=0.10,assuming 36 months accrual and an additional 12 months of follow-up after the last pt has been enrolled.||||0.12
74015520|NCT03716869|147582117|SUPERIORITY||Odds Ratio (OR)|2.07|||<|0.001|TWO_SIDED|95.0|1.39|3.1|||Regression, Logistic|||Statistical analysis was conducted using the intent-to-treat principle. Analysis for primary and secondary outcomes that compared universal to targeted screening was conducted using mixed effects logistic regression.||3.10|1.39|<0.001
74015521|NCT03716869|147582118|SUPERIORITY||Odds Ratio (OR)|5.92|||<|0.001|TWO_SIDED|95.0|5.07|6.93|||Regression, Logistic|||||6.93|5.07|<0.001
74015522|NCT03716869|147582120|SUPERIORITY||Odds Ratio (OR)|3.3|||<|0.001|TWO_SIDED|95.0|2.49|4.38|||Regression, Logistic|||||4.38|2.49|<0.001
74015523|NCT03716869|147582126|SUPERIORITY||Odds Ratio (OR)|8.42|||<|0.001|TWO_SIDED|95.0|6.71|10.58|||Regression, Logistic||Test of interaction terms from mixed-effects logistic regression for subgroup analyses. Information above is sex x rand group interaction for identification of MDD symptoms among females. For males, OR 4.05 (95% CI 3.26-5.03).||"Sex x rand group interaction p=0.005 for SAP confirmation of need for follow-up.~Females 4.73 (3.19-7.02) Males 2.09 (1.38-3.16)~Sex x rand group interaction p=0.37 for treatment initiation. OR is not reported due to p\>0.05."|10.58|6.71|<0.001
74015524|NCT03716869|147582126|SUPERIORITY||Odds Ratio (OR)|8.65|||<|0.001|TWO_SIDED|95.0|6.58|11.35|||Regression, Logistic||Information above is for race/ethnicity x rand group interaction for identification of MDD symptoms for non-Hispanic white students. For non-Hispanic Black students OR 2.55 (95% CI 1.97-3.31), Hispanic 7.45 (4.98-11.17), other 12.41 (7.34-21.00).||"Race/ethnicity x rand group p=0.007 for SAP confirmation of need for follow-up. non-Hispanic white 2.24 (1.59-3.15) non-Hispanic Black 4.19 (2.03-8.65) Hispanic 10.15 (4.06-25.36) Other 12.22 (1.59-94.12)~Race/ethnicity x rand group interaction p=0.15 for treatment initiation. OR is not reported due to p\>0.05."|11.35|6.58|<0.001
74015525|NCT03716869|147582126|SUPERIORITY||Odds Ratio (OR)|5.47||||0.006|TWO_SIDED|95.0|4.65|6.44|||Regression, Logistic||Information above is location x rand group interaction for identification of MDD symptoms among urban students. For rural students and identification of depressive symptoms OR 13.60 (95% CI 7.28-25.42).||"Location x rand group interaction p=0.27 for SAP confirmation of need for follow-up. OR is not reported due to p\>0.05.~Location x rand group interaction p=0.36 for treatment initiation. OR is not reported due to p\>0.05."|6.44|4.65|0.006
74015526|NCT00689572|147582173|EQUIVALENCE|Mixed-effects linear regression model|Mean Difference (Final Values)|-0.09||||0.972|TWO_SIDED|95.0|-5.43|5.25|||Regression, Linear|Mixed-effects linear regression model included random intercept and slope (for temporal trend)||Difference between ondansetron and placebo groups regarding percentage of cocaine-free days (PCFD)||5.25|-5.43|0.972
74015527|NCT00689572|147582174|EQUIVALENCE|Mixed-effects linear regression model|Mean Difference (Final Values)|0.44||||0.909|TWO_SIDED|95.0|-7.08|7.95|||Regression, Linear|Mixed-effects linear regression model included random intercept and slope (for temporal trend)||Difference between ondansetron and placebo groups regarding percentage of cocaine free urines (PCFU)||7.95|-7.08|0.909
74015528|NCT02342015|147582185|OTHER||||||<|0.05|||||||wilcoxon signed-rank test|||||||<0.05
74015529|NCT02342015|147582186|OTHER||||||<|0.05|||||||paired Student's t-test|||||||<0.05
74015530|NCT01692301|147582187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.66|STANDARD_ERROR_OF_MEAN|1.42||0.01|TWO_SIDED|95.0|-6.45|-0.87|||ANCOVA|||||-0.87|-6.45|0.010
74044684|NCT03061812|147641195|SUPERIORITY||Hazard Ratio (HR)|1.51|||<|0.0001|TWO_SIDED|95.0|1.22|1.87|||Log Rank|Two-sided p-value stratified by the randomization stratification factors.|Calculated using a Cox proportional hazards regression model, with treatment and randomization stratification factors as covariates.|||1.87|1.22|< 0.0001
74044685|NCT03061812|147641196|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|95.0|-5.66|4.65||||||||4.65|-5.66|
74044686|NCT03061812|147641197|SUPERIORITY||Odds Ratio (OR)|0.68||||0.3352|TWO_SIDED|95.0|0.39|1.18|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors.||||1.18|0.39|0.3352
74015531|NCT02109484|147582202|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||||0.0165|||||||Wilcoxon (Mann-Whitney)|||||||0.0165
74015532|NCT02109484|147582202|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||<0.0001
74015533|NCT02109484|147582202|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74015534|NCT02109484|147582203|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were peformed||||<0.0001
74015535|NCT02109484|147582203|EQUIVALENCE|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74015536|NCT02109484|147582203|EQUIVALENCE|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||||||0.0006
74015537|NCT02109484|147582204|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Group B 10 mcg P2-VP8 was performed.||||0.0004
74015538|NCT02109484|147582204|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Cohort B 30 mcg P2-VP8 vaccine group was performed.||||<0.0001
74015539|NCT02109484|147582204|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair-wise comparison between the Adjusted Seroresponses in Cohort B Placebo group and the Cohort B P2-VP8 group was performed.||||<0.0001
74015540|NCT02111993|147582208|SUPERIORITY_OR_OTHER|||||||0.02||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.02
74015541|NCT02111993|147582208|SUPERIORITY_OR_OTHER|||||||0.03||||||This p-value correlates to Δ8 hr cTnT.|t-test, 2 sided|||||||0.03
74015542|NCT02111993|147582208|SUPERIORITY_OR_OTHER|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.16
74015543|NCT02111993|147582209|SUPERIORITY_OR_OTHER|||||||0.04||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.04
74015544|NCT02111993|147582209|SUPERIORITY_OR_OTHER|||||||0.06||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided|||||||0.06
74015545|NCT02111993|147582209|SUPERIORITY_OR_OTHER|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.16
74015546|NCT02111993|147582210|SUPERIORITY_OR_OTHER|||||||0.17||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.17
74015547|NCT02111993|147582210|SUPERIORITY_OR_OTHER|||||||0.19||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided|||||||0.19
74015548|NCT02111993|147582210|SUPERIORITY_OR_OTHER|||||||0.38||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.38
74015549|NCT04074928|147582215|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.73|||||TWO_SIDED|95.0|0.645|0.836||||||"Non-inferiority, A/H1N1, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the A/H1N1 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.836|0.645|
74015550|NCT04074928|147582215|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.73|||||TWO_SIDED|95.0|0.656|0.809||||||"Non-inferiority, B/Yamagata, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the B/Yamagata vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.809|0.656|
74015551|NCT04074928|147582215|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.88|||||TWO_SIDED|95.0|0.791|0.972||||||"Non-inferiority, B/Victoria, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the B/Victoria vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.972|0.791|
74015552|NCT04074928|147582216|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-11.46|||||TWO_SIDED|95.0|-16.447|-6.423||||||"Non-inferiority, A/H1N1, SCR difference, Day 29/57~Non-inferiority of the immune response to the A/H1N1 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-6.423|-16.447|
74095349|NCT02906930|147740457|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.1|<0.0001
74095350|NCT02906930|147740457|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.8|<0.0001
74095351|NCT02906930|147740457|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 3 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.9|<0.0001
74095352|NCT02906930|147740457|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.0|-1.5|<0.0001
73880235|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0043|TWO_SIDED|95.0|1.76|20.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||20.66|1.76|0.0043
73880236|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.23||||0.1126|TWO_SIDED|95.0|0.76|13.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.79|0.76|0.1126
74015553|NCT04074928|147582216|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-14.87|||||TWO_SIDED|95.0|-19.61|-9.983||||||"Non-inferiority, B/Yamagata, SCR difference, Day 29/57~Non-inferiority of the immune response to the B/Yamagata vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-9.983|-19.610|
74015554|NCT04074928|147582216|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-5.96|||||TWO_SIDED|95.0|-10.327|-1.44||||||"Non-inferiority, B/Victoria, SCR difference, Day 29/57~Non-inferiority of the immune response to the B/Victoria vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-1.440|-10.327|
74015555|NCT04074928|147582217|NON_INFERIORITY|The noninferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified noninferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|1.04|||||TWO_SIDED|95.0|0.927|1.16||||||"Non-inferiority, A/H3N2, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the A/H3N2 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||1.160|0.927|
74015556|NCT04074928|147582218|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|3.13|||||TWO_SIDED|95.0|-1.443|7.812||||||"Non-inferiority, A/H3N2, SCR difference, Day 29/57~Non-inferiority of the immune response to the A/H3N2 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||7.812|-1.443|
74015557|NCT04074928|147582219|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.79|1.024||||||A/H1N1, GMT ratio, Day 29/57||1.024|0.790|
74015558|NCT04074928|147582219|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.08|||||TWO_SIDED|95.0|0.968|1.195||||||B/Yamagata, GMT ratio, Day 29/57||1.195|0.968|
74015559|NCT04074928|147582219|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.09|||||TWO_SIDED|95.0|0.986|1.202||||||B/Victoria, GMT ratio, Day 29/57||1.202|0.986|
74015560|NCT04074928|147582220|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|-2.52|||||TWO_SIDED|95.0|-7.526|2.461||||||A/H1N1, SCR difference, Day 29/57||2.461|-7.526|
74015561|NCT04074928|147582220|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|-0.04|||||TWO_SIDED|95.0|-4.912|4.911||||||B/Yamagata, SCR difference, Day 29/57||4.911|-4.912|
74015562|NCT04074928|147582220|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|1.18|||||TWO_SIDED|95.0|-2.805|5.353||||||B/Victoria, SCR difference, Day 29/57||5.353|-2.805|
74044687|NCT03061812|147641198|SUPERIORITY||Odds Ratio (OR)|0.73||||0.0358|TWO_SIDED|95.0|0.47|1.12|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors.||||1.12|0.47|0.0358
73880237|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|2.9||||0.1479|TWO_SIDED|95.0|0.69|12.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.30|0.69|0.1479
73888038|NCT01746901|147309532|SUPERIORITY_OR_OTHER||LS Mean Difference|4.1||||0.3904|TWO_SIDED|95.0|-5.3|13.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.6|-5.3|0.3904
74015563|NCT04074928|147582221|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.914|1.165||||||A/H3N2, GMT ratio, Day 29/57||1.165|0.914|
74015564|NCT04074928|147582222|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|1.89|||||TWO_SIDED|95.0|-3.006|6.856||||||A/H3N2, SCR difference, Day 29/57||6.856|-3.006|
74044688|NCT01176240|147641213|SUPERIORITY_OR_OTHER|||||||0.978|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||Study 306A was initially designed as a blinded interim analysis by an independent DMC to ensure that the overall study was adequately powered. Study 306A was not powered to provide statistical significance as a stand alone study. Thus, no additional efficacy end points were prospectively defined beyond the primary end point.||||0.978
74044689|NCT01176240|147641214|SUPERIORITY_OR_OTHER|||||||0.018||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.018
74044690|NCT01176240|147641216|SUPERIORITY_OR_OTHER|||||||0.6||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the first secondary endpoint was not positive, statistical analysis was not performed on additional secondary endpoints.|Wilcoxon (Mann-Whitney)|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.60
74015565|NCT02685709|147582229|NON_INFERIORITY|An assessment of NI was made by comparing the lower bound of the two-sided 95% confidence interval (CI) for the difference in biochemical control (octreotide capsules - SRLs) to a NI margin of -20%.|95% CI Stratified Miettinen & Nurminen|-19.9|||||TWO_SIDED|95.0|-19.9|0.5|||Stratified Miettinen & Nurminen (M&N)|||||0.5|-19.9|
74015566|NCT02685709|147582230|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
74015567|NCT02685709|147582231|OTHER||||||||||||||Clopper-Pearson method|||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
74015568|NCT02685709|147582232|OTHER|||||||||||||Confidence interval was applied||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
74095353|NCT02906930|147740457|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.7|<0.0001
74095354|NCT02906930|147740458|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.5|-3.1|<0.0001
74095355|NCT02906930|147740458|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9||||0.0866|TWO_SIDED|95.0|-1.9|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.1|-1.9|0.0866
74095356|NCT02906930|147740458|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1||||0.8692|TWO_SIDED|95.0|-0.9|0.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.8|-0.9|0.8692
74095357|NCT02906930|147740458|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.2||||0.7075|TWO_SIDED|95.0|-1.0|0.6|||MMRM||Oral Semaglutide 3 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.6|-1.0|0.7075
74095358|NCT02906930|147740458|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.0||||0.0138|TWO_SIDED|95.0|-1.8|-0.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-1.8|0.0138
74095359|NCT02906930|147740458|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.8|-3.4|<0.0001
74095360|NCT02906930|147740481|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.45||||0.0043|TWO_SIDED|95.0|0.26|0.78||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.78|0.26|0.0043
73888039|NCT01746901|147309532|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.6524|TWO_SIDED|95.0|-7.3|11.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.6|-7.3|0.6524
74015569|NCT02685709|147582233|OTHER||||||||||||||Clopper-Pearson method|||Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.|Based on this analysis 63.0% of patients in the octreotide capsule group and 51.4% of patients in the SRL injection group entered the Study Extension phase.|||
74015570|NCT02685709|147582234|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The mean change in IGF-1 from RCT Baseline to the end of the RCT phase was calculated using the Last Observation Carried Forward (LOCF) approach.|||
74015571|NCT02685709|147582235|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|Estimates were obtained from an analysis of covariance (ANCOVA) for the mean integrated growth hormone (GH) change from baseline with explanatory factors of treatment group and baseline value.|||
74015572|NCT02685709|147582236|OTHER|||||||||||||||||This endpoint is descriptive with no formal statistical hypothesis testing|The week 26 value was used as the baseline value for the RCT phase. The denominator for the percentage was the number of subjects at each visit.|||
74015573|NCT02685709|147582237|OTHER|||||||||||||||||This endpoint is descriptive with no formal statistical hypothesis testing.|The week 26 value is used as the baseline value for the RCT phase. The denominator for the percentage was the number of subjects at each visit.|||
74015574|NCT02685709|147582238|OTHER|||||||||||||||||This endpoints is descriptive with no formal statistical hypothesis testing.|This sensitivity analysis was using the Full analysis set (FAS), where any patient who discontinued treatment early was imputed as non-responder.|||
74044691|NCT01176240|147641222|SUPERIORITY_OR_OTHER|||||||0.238|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||||||0.238
74044692|NCT00807014|147641231|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Analysis of covariance (ANCOVA) model was used with terms for baseline value, treatment, and center. Treatment-by-center interaction was not included.|ANCOVA|||||||<0.001
74044693|NCT03906136|147641251|SUPERIORITY||Odds Ratio (OR)|0.69||||0.119|TWO_SIDED|95.0|0.43|1.1|||Regression, Logistic|||Week 24||1.10|0.43|0.119
74044694|NCT03906136|147641252|SUPERIORITY||Odds Ratio (OR)|0.59||||0.029|TWO_SIDED|95.0|0.37|0.95|||Regression, Logistic|||Week 12||0.95|0.37|0.029
74044695|NCT03906136|147641253|SUPERIORITY||Odds Ratio (OR)|0.71||||0.154|TWO_SIDED|95.0|0.45|1.14|||Regression, Logistic|||Week 12||1.14|0.45|0.154
74044696|NCT03906136|147641253|SUPERIORITY||Odds Ratio (OR)|0.87||||0.562|TWO_SIDED|95.0|0.54|1.39|||Regression, Logistic|||Week 24||1.39|0.54|0.562
74044697|NCT03906136|147641254|SUPERIORITY||Odds Ratio (OR)|0.55||||0.029|TWO_SIDED|95.0|0.32|0.94|||Regression, Logistic|||Week 12||0.94|0.32|0.029
74015575|NCT02685709|147582239|OTHER|||||||||||||||||This endpoints is descriptive with no formal statistical hypothesis testing|This sensitivity analysis was using the Full analysis set (FAS), where patient who were biochemically controlled at the RCT Baseline (week 26), and who discontinued treatment early was imputed as non-responder.|||
74044698|NCT03906136|147641254|SUPERIORITY||Odds Ratio (OR)|0.74||||0.264|TWO_SIDED|95.0|0.44|1.25|||Regression, Logistic|||Week 24||1.25|0.44|0.264
74044699|NCT03906136|147641255|SUPERIORITY||Odds Ratio (OR)|0.49||||0.008|TWO_SIDED|95.0|0.29|0.83|||Regression, Logistic|||Week 12||0.83|0.29|0.008
74044700|NCT03906136|147641255|SUPERIORITY||Odds Ratio (OR)|0.47||||0.005|TWO_SIDED|95.0|0.28|0.8|||Regression, Logistic|||Week 24||0.80|0.28|0.005
74044701|NCT03906136|147641256|SUPERIORITY||Odds Ratio (OR)|0.72||||0.263|TWO_SIDED|95.0|0.4|1.28|||Regression, Logistic|||Week 12||1.28|0.40|0.263
74044702|NCT03906136|147641256|SUPERIORITY||Odds Ratio (OR)|0.61||||0.103|TWO_SIDED|95.0|0.34|1.1|||Regression, Logistic|||Week 24||1.10|0.34|0.103
74044703|NCT03906136|147641257|SUPERIORITY||Odds Ratio (OR)|0.64||||0.055|TWO_SIDED|95.0|0.4|1.01|||Regression, Logistic|||Week 12||1.01|0.40|0.055
74044704|NCT03906136|147641257|SUPERIORITY||Odds Ratio (OR)|0.82||||0.409|TWO_SIDED|95.0|0.52|1.31|||Regression, Logistic|||Week 24||1.31|0.52|0.409
74015576|NCT02685709|147582240|OTHER||Proportion of patients|64.4|||||TWO_SIDED|95.0|56.0|72.1|||||Confidence Interval estimated using the Clopper-Pearson (Exact) method.||The proportion of patients biochemically controlled at the end of the Run-in phase was defined as IGF-1 \< 1.3 times ULN \[based on the average of week 24 and week 26\])|72.1|56|
74015577|NCT02685709|147582241|OTHER||Proportion of patients|66.4|||||TWO_SIDED|95.0|58.5|74.1||||||||74.1|58.5|
74015578|NCT02685709|147582242|OTHER||Proportion of patients|48.9|||||TWO_SIDED|95.0|38.7|59.1||||||||59.1|38.7|
74015579|NCT02685709|147582246|OTHER||||||||||||||||||The LSM change from baseline estimates are from a mixed model for repeated measures.|||
74015580|NCT00784654|147582247|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||< 0.001
74015581|NCT00784654|147582248|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74015582|NCT00784654|147582249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED|95.0|-15.4|-9.8|||ANCOVA|||||-9.8|-15.4|<0.001
74044705|NCT03906136|147641258|SUPERIORITY||Odds Ratio (OR)|0.85||||0.477|TWO_SIDED|95.0|0.53|1.34|||Regression, Logistic|||Week 12||1.34|0.53|0.477
74044706|NCT03906136|147641258|SUPERIORITY||Odds Ratio (OR)|1.01||||0.968|TWO_SIDED|95.0|0.63|1.61|||Regression, Logistic|||Week 24||1.61|0.63|0.968
74044707|NCT03906136|147641259|SUPERIORITY||Odds Ratio (OR)|0.3||||0.205|TWO_SIDED|95.0|-0.16|0.75|||Regression, Logistic|||Week 12||0.75|-0.16|0.205
74044708|NCT03906136|147641259|SUPERIORITY||Odds Ratio (OR)|0.37||||0.108|TWO_SIDED|95.0|-0.08|0.82|||Regression, Logistic|||Week 24||0.82|-0.08|0.108
74044709|NCT03906136|147641260|SUPERIORITY||Mean Difference (Net)|0.06||||0.525|TWO_SIDED|95.0|-0.12|0.23|||Mixed Models Analysis|||Week 12||0.23|-0.12|0.525
74044710|NCT03906136|147641260|SUPERIORITY||Mean Difference (Net)|-0.06||||0.577|TWO_SIDED|95.0|-0.25|0.14|||Mixed Models Analysis|||Week 24||0.14|-0.25|0.577
74044711|NCT03906136|147641261|SUPERIORITY||Odds Ratio (OR)|-0.89||||0.22|TWO_SIDED|95.0|-2.32|0.54|||Mixed Models Analysis|||Week 12||0.54|-2.32|0.220
74044712|NCT03906136|147641261|SUPERIORITY||Median Difference (Net)|-0.1||||0.745|TWO_SIDED|95.0|-0.7|0.5|||Regression, Logistic|||Week 24||0.50|-0.70|0.745
73880238|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|10.49||||0.001|TWO_SIDED|95.0|2.59|42.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||42.46|2.59|0.0010
73880239|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|13.01||||0.0002|TWO_SIDED|95.0|3.31|51.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||51.14|3.31|0.0002
74044713|NCT03906136|147641262|SUPERIORITY||Mean Difference (Net)|-0.13||||0.768|TWO_SIDED|95.0|-1.01|0.74|||Mixed Models Analysis|||Week 12||0.74|-1.01|0.768
74044714|NCT03906136|147641262|SUPERIORITY||Mean Difference (Net)|-0.37||||0.451|TWO_SIDED|95.0|-1.34|0.6|||Mixed Models Analysis|||Week 24||0.60|-1.34|0.451
74044715|NCT03906136|147641263|SUPERIORITY||Mean Difference (Net)|0.26||||0.477|TWO_SIDED|95.0|-0.46|0.97|||Mixed Models Analysis|||Week 12||0.97|-0.46|0.477
74044716|NCT03906136|147641263|SUPERIORITY||Mean Difference (Net)|-0.17||||0.66|TWO_SIDED|95.0|-0.92|0.58|||Mixed Models Analysis|||Week 24||0.58|-0.92|0.660
74044717|NCT03906136|147641264|SUPERIORITY||Mean Difference (Net)|0.17||||0.586|TWO_SIDED|95.0|-0.45|0.79|||Mixed Models Analysis|||Week 12||0.79|-0.45|0.586
74044718|NCT03906136|147641264|SUPERIORITY||Median Difference (Net)|0.21||||0.491|TWO_SIDED|95.0|-0.39|0.82|||Mixed Models Analysis|||Week 24||0.82|-0.39|0.491
74044719|NCT03906136|147641265|SUPERIORITY|Week 12|Mean Difference (Net)|4.49||||0.082|TWO_SIDED|95.0|-0.58|9.56|||Mixed Models Analysis|||||9.56|-0.58|0.082
74044720|NCT03906136|147641265|SUPERIORITY||Median Difference (Net)|2.73||||0.292|TWO_SIDED|95.0|-2.35|7.81|||Mixed Models Analysis|||Week 24||7.81|-2.35|0.292
74044721|NCT00878644|147641266|SUPERIORITY||Risk Difference (RD)|7.3||||0.14|TWO_SIDED|95.0|-1.5|16.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||16.1|-1.5|0.14
74044722|NCT00878644|147641267|SUPERIORITY||Risk Difference (RD)|9.1||||0.13|TWO_SIDED|95.0|-1.8|19.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||19.9|-1.8|0.13
74095361|NCT02906930|147740481|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|TWO_SIDED|95.0|0.18|0.59||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.59|0.18|0.0002
74095362|NCT02906930|147740481|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|TWO_SIDED|95.0|0.19|0.6||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.60|0.19|0.0002
74044723|NCT00878644|147641268|SUPERIORITY|||||||0.13|||||||Stratified Mann-Whitney Test|Test stratified by age category (\<2 years, 2 to \<12 years, or \>=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.|||0.13
74044724|NCT00878644|147641269|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."||||||0.81
74044725|NCT02371980|147641275|SUPERIORITY||Hazard Ratio (HR)|0.517||||0.006|TWO_SIDED|95.0|0.323|0.828||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo||0.828|0.323|0.006
74044726|NCT02371980|147641275|SUPERIORITY||Hazard Ratio (HR)|0.476||||0.002|TWO_SIDED|95.0|0.296|0.767||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo||0.767|0.296|0.002
74044727|NCT02371980|147641275|SUPERIORITY||Hazard Ratio (HR)|0.483||||0.003|TWO_SIDED|95.0|0.298|0.782||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo||0.782|0.298|0.003
74044728|NCT02371980|147641276|SUPERIORITY||Least Squares Mean (LSM) Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.59||0.421|TWO_SIDED|95.0|-1.63|0.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.68|-1.63|0.421
74044729|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.589||0.037|TWO_SIDED|95.0|-2.39|-0.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||-0.08|-2.39|0.037
74044730|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.592||0.488|TWO_SIDED|95.0|-1.57|0.75|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.75|-1.57|0.488
74015583|NCT00784654|147582252|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
74015584|NCT00784654|147582256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 1 sided|||||||<0.001
74015585|NCT00784654|147582257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5|||<|0.001|TWO_SIDED|95.0|3.5|9.5|||ANCOVA|||||9.5|3.5|<0.001
74015586|NCT00784654|147582258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 1 sided|||||||<0.001
74015587|NCT00784654|147582259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|||<|0.001|TWO_SIDED|95.0|-0.26|-0.11|||ANCOVA|||||-0.11|-0.26|<0.001
74015588|NCT00784654|147582262|SUPERIORITY_OR_OTHER_LEGACY|||||||0.726||95.0|||||Cochran-Mantel-Haenszel|||||||0.726
74015589|NCT00262873|147582267|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
74015590|NCT00262873|147582268|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
74015591|NCT00262873|147582269|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
74015592|NCT00844753|147582273|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Chi-squared|||||||0.47
74015593|NCT00844753|147582274|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Chi-squared|||||||0.95
74015594|NCT05110300|147582281|SUPERIORITY|||||||0.0283||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0283
74015595|NCT05110300|147582282|SUPERIORITY|||||||0.3118||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3118
74015596|NCT05110300|147582283|SUPERIORITY|||||||0.213||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.213
74015597|NCT05110300|147582283|EQUIVALENCE|MDC of the inpatient stroke population for the BBS was used as the equivalence bounds. Equivalence bounds were set at +/- 6.9|||||<|0.001||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||||||<0.001
74015598|NCT05110300|147582283|SUPERIORITY|||||||0.32||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.320
74015599|NCT05110300|147582284|SUPERIORITY|||||||0.2612||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.2612
74015600|NCT05110300|147582285|SUPERIORITY|||||||0.541||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.5410
74015601|NCT05110300|147582286|SUPERIORITY|||||||0.6282||||||The a priori threshold for statistical significance was p\<0.05.|Wilcoxon (Mann-Whitney)|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.6282
74015602|NCT05110300|147582286|SUPERIORITY|||||||0.5056||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.5056
74015603|NCT05110300|147582287|SUPERIORITY|||||||0.558||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.5580
74015604|NCT05110300|147582288|SUPERIORITY|||||||0.0897||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0897
74015605|NCT05110300|147582289|SUPERIORITY|||||||0.0549||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.0549
74015606|NCT05110300|147582289|SUPERIORITY|||||||0.05626||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.05626
74015607|NCT05110300|147582290|SUPERIORITY|||||||0.0706||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0706
74044731|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.765||0.002|TWO_SIDED|95.0|-3.93|-0.93|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.93|-3.93|0.002
74044732|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.761|<|0.001|TWO_SIDED|95.0|-4.49|-1.51|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-1.51|-4.49|<0.001
74044733|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.775||0.001|TWO_SIDED|95.0|-4.02|-0.98|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.98|-4.02|0.001
74044734|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|0.924||0.001|TWO_SIDED|95.0|-4.76|-1.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-1.13|-4.76|0.001
74044735|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|0.919|<|0.001|TWO_SIDED|95.0|-5.64|-2.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-2.03|-5.64|<0.001
74044736|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.939||0.001|TWO_SIDED|95.0|-4.84|-1.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-1.16|-4.84|0.001
74044737|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-2.92|STANDARD_ERROR_OF_MEAN|0.938||0.002|TWO_SIDED|95.0|-4.76|-1.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-1.08|-4.76|0.002
74044738|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-4.51|STANDARD_ERROR_OF_MEAN|0.934|<|0.001|TWO_SIDED|95.0|-6.34|-2.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-2.68|-6.34|<0.001
74044739|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|0.949|<|0.001|TWO_SIDED|95.0|-5.5|-1.78|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-1.78|-5.50|<0.001
74044740|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.957||0.033|TWO_SIDED|95.0|-3.92|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.16|-3.92|0.033
74044741|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-3.69|STANDARD_ERROR_OF_MEAN|0.952|<|0.001|TWO_SIDED|95.0|-5.55|-1.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-1.82|-5.55|<0.001
74044742|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.967||0.007|TWO_SIDED|95.0|-4.52|-0.73|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.73|-4.52|0.007
74044743|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|0.912||0.004|TWO_SIDED|95.0|-4.4|-0.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.82|-4.40|0.004
74095363|NCT02906930|147740482|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.03|TWO_SIDED|95.0|0.25|0.93||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.93|0.25|0.0300
74044744|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-4.09|STANDARD_ERROR_OF_MEAN|0.906|<|0.001|TWO_SIDED|95.0|-5.86|-2.31|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-2.31|-5.86|<0.001
74044745|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|0.921||0.003|TWO_SIDED|95.0|-4.57|-0.96|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.96|-4.57|0.003
74044746|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-1.92|STANDARD_ERROR_OF_MEAN|1.008||0.057|TWO_SIDED|95.0|-3.89|0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.06|-3.89|0.057
73888040|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.1771|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.1|-0.4|0.1771
74015608|NCT05110300|147582291|SUPERIORITY|||||||0.1629||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.1629
74015609|NCT05110300|147582292|SUPERIORITY|||||||0.4271||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.4271
74015610|NCT05110300|147582292|SUPERIORITY|||||||0.419||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.4190
74015611|NCT05110300|147582293|SUPERIORITY|||||||0.3444||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3444
74015612|NCT05110300|147582294|SUPERIORITY|||||||0.3581||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3581
74015613|NCT05110300|147582295|SUPERIORITY|||||||0.906||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.9060
74015614|NCT05110300|147582295|SUPERIORITY|||||||0.0848||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.0848
74015615|NCT01662440|147582308|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the Rabies vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% Confidence Intervals (CI) of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 7 days after last active vaccination is greater than -5.|Difference in percentages of subjects|0.0|||||TWO_SIDED|97.5|-2.8|2.8||||||To establish non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) accelerated schedule as compared to conventional schedule at 7 days after last active vaccination.||2.8|-2.8|
74015616|NCT01662440|147582309|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the JE vaccine is considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 28 days after last active vaccination is greater than -10.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|97.5|-4.8|7.9||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) accelerated schedule as compared to conventional schedule at 28 day after last active vaccination||7.9|-4.8|
74015617|NCT01662440|147582310|NON_INFERIORITY_OR_EQUIVALENCE|The conventional schedule of Rabies vaccine co-administered with JE vaccine considered non inferior to the conventional schedule of Rabies vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMCs measured 28 days after last active vaccination is greater than 0.667.|Between groups ratio of GMCs|1.07|||||TWO_SIDED|95.0|0.86|1.32||||||Non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) as compared to Rabies vaccines (administered alone) as given according to conventional schedule at 28day after last active vaccination||1.32|0.86|
74044747|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.997|<|0.001|TWO_SIDED|95.0|-5.46|-1.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-1.55|-5.46|<0.001
74044748|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.011||0.012|TWO_SIDED|95.0|-4.51|-0.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-0.55|-4.51|0.012
74044749|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.012||0.061|TWO_SIDED|95.0|-3.88|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.09|-3.88|0.061
74044750|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-2.36|STANDARD_ERROR_OF_MEAN|0.997||0.018|TWO_SIDED|95.0|-4.31|-0.4|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||-0.40|-4.31|0.018
74044751|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|1.015||0.065|TWO_SIDED|95.0|-3.87|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.12|-3.87|0.065
74044752|NCT02371980|147641276|SUPERIORITY||MMRM Model|-3.09|STANDARD_ERROR_OF_MEAN|1.136||0.007|TWO_SIDED|95.0|-5.31|-0.86|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.86|-5.31|0.007
74044753|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-3.97|STANDARD_ERROR_OF_MEAN|1.122|<|0.001|TWO_SIDED|95.0|-6.16|-1.77|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-1.77|-6.16|<0.001
74044754|NCT02371980|147641276|SUPERIORITY||Least Squares Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|1.143||0.002|TWO_SIDED|95.0|-5.82|-1.34|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-1.34|-5.82|0.002
74044755|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.085||0.732|TWO_SIDED|95.0|-0.2|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.14|-0.20|0.732
74044756|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.085||0.273|TWO_SIDED|95.0|-0.26|0.07|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.07|-0.26|0.273
74044757|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.085||0.361|TWO_SIDED|95.0|-0.24|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.09|-0.24|0.361
74044758|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.099||0.004|TWO_SIDED|95.0|-0.48|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.09|-0.48|0.004
74044759|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.099||0.002|TWO_SIDED|95.0|-0.5|-0.12|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.12|-0.50|0.002
74044760|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.16|-0.55|<0.001
74044761|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.121||0.014|TWO_SIDED|95.0|-0.54|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.06|-0.54|0.014
73880240|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1483|TWO_SIDED|95.0|0.68|12.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.41|0.68|0.1483
74044762|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.121||0.001|TWO_SIDED|95.0|-0.63|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.16|-0.63|0.001
74044763|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.123||0.002|TWO_SIDED|95.0|-0.62|-0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.14|-0.62|0.002
74044764|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.122||0.025|TWO_SIDED|95.0|-0.51|-0.03|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.03|-0.51|0.025
74044765|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.74|-0.26|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.26|-0.74|<0.001
74044766|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.124||0.002|TWO_SIDED|95.0|-0.63|-0.15|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.15|-0.63|0.002
74044767|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.123||0.333|TWO_SIDED|95.0|-0.36|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||0.12|-0.36|0.333
74044768|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.122||0.002|TWO_SIDED|95.0|-0.61|-0.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.13|-0.61|0.002
74044769|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.124||0.023|TWO_SIDED|95.0|-0.53|-0.04|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.04|-0.53|0.023
74044770|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.121||0.092|TWO_SIDED|95.0|-0.44|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||0.03|-0.44|0.092
74044771|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.121|<|0.001|TWO_SIDED|95.0|-0.67|-0.2|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.20|-0.67|<0.001
74044772|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.122||0.008|TWO_SIDED|95.0|-0.57|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.09|-0.57|0.008
74044773|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.248|TWO_SIDED|95.0|-0.42|0.11|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.11|-0.42|0.248
74044774|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.133||0.006|TWO_SIDED|95.0|-0.63|-0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-0.10|-0.63|0.006
74044775|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.135||0.087|TWO_SIDED|95.0|-0.5|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.03|-0.50|0.087
74044776|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.131||0.362|TWO_SIDED|95.0|-0.38|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.14|-0.38|0.362
74044777|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.129||0.251|TWO_SIDED|95.0|-0.4|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.10|-0.40|0.251
74044778|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.131||0.391|TWO_SIDED|95.0|-0.37|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.14|-0.37|0.391
74044779|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.141||0.209|TWO_SIDED|95.0|-0.45|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||0.10|-0.45|0.209
74044780|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.139||0.018|TWO_SIDED|95.0|-0.6|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.06|-0.60|0.018
74044781|NCT02371980|147641277|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.141||0.009|TWO_SIDED|95.0|-0.65|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.09|-0.65|0.009
74015618|NCT01662440|147582311|NON_INFERIORITY_OR_EQUIVALENCE|The conventional schedule of JE vaccine co-administered with Rabies vaccine considered non inferior to the conventional schedule of JE vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMTs measured 28 days after last active vaccination is greater than 0.5.|Ratio of GMTs|0.88|||||TWO_SIDED|95.0|0.68|1.13||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as compared to JE vaccine (administered alone) as given according to conventional schedule at day 28 after last active vaccination.||1.13|0.68|
74044782|NCT02371980|147641279|SUPERIORITY||Hazard Ratio (HR)|0.481||||0.002|TWO_SIDED|95.0|0.302|0.766||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo||0.766|0.302|0.002
74044783|NCT02371980|147641279|SUPERIORITY||Hazard Ratio (HR)|0.455|||<|0.001|TWO_SIDED|95.0|0.286|0.725||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo||0.725|0.286|<0.001
74044784|NCT02371980|147641279|SUPERIORITY||Hazard Ratio (HR)|0.484||||0.002|TWO_SIDED|95.0|0.304|0.771||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo||0.771|0.304|0.002
74044785|NCT01731990|147641280|SUPERIORITY_OR_OTHER_LEGACY||Treatment effect for ratio to placebo|1.06||||0.284|TWO_SIDED|90.0|0.97|1.15|||Mixed Models Analysis|||||1.15|0.97|0.284
74044786|NCT02971007|147641315|OTHER|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.||||||||||||||||No formal sample size calculations were made. The sample size was determined empirically rather than with a specific statistical rationale and is considered sufficient to achieve the study objectives of this proof of concept study. Women with moderate to severe Vulvovaginal candidiasis were randomized in a 1:1:1 ratio to 1 of 3 treatment groups, stratified by signs and symptoms composite score of up to 12 (moderate) and greater than 13 (severe).|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.|||
74044787|NCT02009930|147641320|OTHER||Wilson Method used|16.0|||||TWO_SIDED|95.0|9.4|22.9||||||||22.9|9.4|
74044788|NCT02009930|147641321|OTHER||||||||||||||||||Only descriptive statistics were calculated (frequency, percent). Inferential statistics were not necessary, nor appropriate|||
74044789|NCT02009930|147641322|OTHER|||||||0.79||||||Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor expressed as a p-value|Spearman's Rank Correlation Coefficient|Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor. Spearman's rho = 0.04||Compare risk categories (FRS and CAC)||||0.79
74044790|NCT02009930|147641323|OTHER|||||||0.063||||||Relationship between FRS and metabolic syndrome. FRS risk category (low, mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||FRS risk category (low, mod, mod-high, high, very high risk)||||0.063
74044791|NCT02009930|147641323|OTHER|||||||0.21||||||Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high)||||0.21
74044792|NCT02009930|147641324|OTHER|||||||0.56||||||Relationship between FRS and living in the dorms. FRS risk category (low, mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||FRS risk categories (low, moderate, mod -high, high, and very high)||||0.56
74044793|NCT02009930|147641324|OTHER|||||||0.13||||||Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||CAC risk category (low, low-mod, moderate - high, high, and very high)||||0.13
74044794|NCT02009930|147641325|OTHER|||||||0.44||||||Relationship between FRS and PT failures. FRS risk category (low, mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, PT failure - with/without PT failure) expressed as a p-value||FRS risk categories (low, moderate, moderate-high, high, and very high)||||0.44
74044795|NCT02009930|147641325|OTHER|||||||0.49||||||Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value||CAC risk categories (low, low-moderate, mod -high, high, and very high)||||0.49
74044796|NCT02009930|147641326|OTHER|||||||0.11||||||Relationship between FRS and overall years of service. FRS risk category (low, mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, overall years of service) expressed as a p-value||FRS risk categories (low, moderate, moderate -high, high, and very high)||||0.11
74044797|NCT02009930|147641326|OTHER|||||||0.003||||||Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high risk)||||0.003
74015619|NCT01662440|147582312|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the Rabies vaccine is considered non-inferior to the Rabies vaccine conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 28 days after last active vaccine administration is greater than -5.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|95.0|-3.8|1.4||||||Non-inferiority of the Rabies immune response (administered concomitantly with JE vaccine) as given according to an accelerated schedule as compared Rabies vaccine (administered alone) as given to a conventional schedule at day 28 after last active vaccination||1.4|-3.8|
74044798|NCT02009930|147641328|OTHER|||||||0.21||||||Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high)||||0.21
74044799|NCT02009930|147641329|OTHER|||||||0.13||||||Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||CAC risk category (low, low-mod, moderate - high, high, and very high)||||0.13
74044800|NCT02009930|147641330|OTHER|||||||0.49||||||Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value||CAC risk categories (low, low-moderate, mod -high, high, and very high)||||0.49
74044801|NCT02009930|147641331|OTHER|||||||0.003||||||Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high risk)||||0.003
74044802|NCT02408484|147641371|OTHER|||||||0.0028||||||p-value for the change in MCF from baseline to 1 hour post infusion for the firstBLEED population|ANOVA|||||||0.0028
74044803|NCT02408484|147641371|OTHER|||||||0.0002||||||p-value for the change in MCF from baseline to 1 hour post infusion for the BLEED population|ANOVA|||||||0.0002
74044804|NCT05516134|147641398|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||baseline vs. treatment, paired sample t-test||||<0.01
74044805|NCT05516134|147641399|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
74044806|NCT05516134|147641400|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
74044807|NCT05516134|147641401|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
73880241|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|4.03||||0.0557|TWO_SIDED|95.0|0.97|16.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||16.84|0.97|0.0557
73880242|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|6.47||||0.0072|TWO_SIDED|95.0|1.66|25.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||25.28|1.66|0.0072
73880243|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9715|TWO_SIDED|95.0|0.32|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.24|0.32|0.9715
73880244|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|1.49||||0.472|TWO_SIDED|95.0|0.5|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.39|0.50|0.4720
73880245|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1262|TWO_SIDED|95.0|0.79|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.05|0.79|0.1262
73880246|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0396|TWO_SIDED|95.0|1.05|8.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.92|1.05|0.0396
73880247|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|0.66||||0.5137|TWO_SIDED|95.0|0.19|2.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.29|0.19|0.5137
73880248|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|2.25||||0.137|TWO_SIDED|95.0|0.77|6.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.58|0.77|0.1370
73880249|NCT03192176|147297620|SUPERIORITY||Odds Ratio (OR)|1.39||||0.5526|TWO_SIDED|95.0|0.47|4.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.07|0.47|0.5526
73880250|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|5.75||||0.0012|TWO_SIDED|95.0|1.99|16.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.62|1.99|0.0012
73880251|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|8.86|||<|0.0001|TWO_SIDED|95.0|3.06|25.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.68|3.06|<0.0001
73880252|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|11.55|||<|0.0001|TWO_SIDED|95.0|3.94|33.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.85|3.94|<0.0001
73880253|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|13.55|||<|0.0001|TWO_SIDED|95.0|4.55|40.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||40.38|4.55|<0.0001
74015620|NCT01662440|147582313|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the JE vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 7 days after last active vaccine administration is greater than -10.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|95.0|-4.1|6.2||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as given according to an accelerated schedule as compared to JE vaccine (administered alone) as given according to a conventional schedule at 7day after last active vaccine administration.||6.2|-4.1|
73880254|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0555|TWO_SIDED|95.0|0.98|8.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.61|0.98|0.0555
74044808|NCT05516134|147641402|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
74044809|NCT05516134|147641403|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||.11
74044810|NCT05516134|147641404|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
73880255|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|7.98||||0.0001|TWO_SIDED|95.0|2.75|23.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.18|2.75|0.0001
74044811|NCT05516134|147641405|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
74044812|NCT03805971|147641407|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||"The objective of the test is to assess if the pCLE feature full chia seed sign is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."||||0.0003
73888041|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.3944|TWO_SIDED|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-1.7|0.3944
74015621|NCT02229552|147582323|OTHER|Repeated measures analysis of variance with zbmi for each year as the repeated dependent measure.|Mean Difference (Final Values)|3.0||||0.051|TWO_SIDED||||||ANOVA|||||||0.051
74015622|NCT04872101|147582324|SUPERIORITY||Risk Difference (RD)|22.2|||<|0.001|TWO_SIDED|95.0|15.8|28.5||5% significance level (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||28.5|15.8|<0.001
74015623|NCT04872101|147582325|SUPERIORITY||Risk Difference (RD)|22.9|||<|0.001|TWO_SIDED|95.0|16.0|29.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.8|16.0|<0.001
74015624|NCT04872101|147582326|SUPERIORITY||Risk Difference (RD)|6.5||||0.043|TWO_SIDED|95.0|0.8|12.3||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||12.3|0.8|0.043
74015625|NCT04872101|147582327|SUPERIORITY||Risk Difference (RD)|27.4|||<|0.001|TWO_SIDED|95.0|19.0|35.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.8|19.0|<0.001
74044813|NCT03805971|147641407|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the malignant pleural infiltrations group than in the benign pleura group."||||<0.0001
74044814|NCT03805971|147641407|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||"The objective is to assess if the pCLE feature cellular shape homogeneity is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."||||0.0052
74044815|NCT03805971|147641407|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if dysplastic vessels are more frequently found in the malignant pleural infiltrations group than in the benign pleura group."||||<0.0001
74044816|NCT03012594|147641421|SUPERIORITY|||||||0.07|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.07
74044817|NCT00927576|147641549|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis of the results showed a 95% chance of finding a p\<0.05 difference in 166 subjects and a 99% chance of finding a p \<0.05 difference in 230 subjects in comparison of Group 1 controls and sTBI patients.|Difference in z-score, sTBI vs. controls|2.04|||<|0.001|TWO_SIDED||||||ANOVA|for repeated measures with effect sizes (omega squared).||The null hypotheses was that the severe TBI group would not differ from the control group in SRT latencies.||||< 0.001
74044818|NCT00927576|147641549|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis of controls (i.e., with z-score = 0) showed a 95% chance of detecting a p \< 0.05 significance level for z-scores exceeding 0.54 in the mild TBI patient group..|z-score difference between groups|-0.3||||0.5|TWO_SIDED|||||The P-value reflects the likelihood of detection a difference of the magnitude observed.|ANOVA|||The null hypothesis was that the mild TBI group would not differ in age-corrected z-score from that of a control subjects in the large control group.||||.50
74044819|NCT01094808|147641568|SUPERIORITY_OR_OTHER||mean value for 200 mg Pregabalin|33.391|STANDARD_DEVIATION|22.106||0.14||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects||||0.14
74044820|NCT01094808|147641569|SUPERIORITY_OR_OTHER||mean value for 200 mg Pregabalin|35.301|STANDARD_DEVIATION|22.295||0.12||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects||||0.12
74044821|NCT01224106|147641578|SUPERIORITY||Effect Size|-0.044||||0.6744|TWO_SIDED|95.0|-0.248|0.161|||Mixed Models Analysis|||||0.161|-0.248|0.6744
74044822|NCT01224106|147641578|SUPERIORITY||Effect Size|-0.085||||0.4494|TWO_SIDED|95.0|-0.304|0.135|||Mixed Models Analysis|||||0.135|-0.304|0.4494
74044823|NCT01224106|147641580|SUPERIORITY||Effect Size|0.035||||0.7458|TWO_SIDED|95.0|-0.179|0.25|||Mixed Models Analysis|||||0.250|-0.179|0.7458
74044824|NCT01224106|147641580|SUPERIORITY||Effect Size|0.042||||0.723|TWO_SIDED|95.0|-0.191|0.275|||Mixed Models Analysis|||||0.275|-0.191|0.723
74044825|NCT01224106|147641584|SUPERIORITY||Effect Size|-0.191||||0.0825|TWO_SIDED|95.0|-0.407|0.025|||Mixed Models Analysis|||||0.025|-0.407|0.0825
74044826|NCT01224106|147641584|SUPERIORITY||Effect Size|0.043||||0.7171|TWO_SIDED|95.0|-0.19|0.276|||Mixed Models Analysis|||||0.276|-0.19|0.7171
74044827|NCT01224106|147641587|SUPERIORITY|||||||0.9734|||||||Mixed Models Analysis|||"Statistical analysis of the Abeta 1-42 CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.9734
74044828|NCT01224106|147641587|SUPERIORITY|||||||0.0629|||||||Mixed Models Analysis|||"Statistical analysis of the Abeta 1-42 CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0629
74044829|NCT01224106|147641587|SUPERIORITY|||||||0.0084|||||||Mixed Models Analysis|||"Statistical analysis of the p-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0084
74044830|NCT01224106|147641587|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||"Statistical analysis of the p-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0003
73880256|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|8.07||||0.0001|TWO_SIDED|95.0|2.81|23.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.19|2.81|0.0001
73880257|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.55||||0.0012|TWO_SIDED|95.0|1.82|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.39|1.82|0.0012
73880258|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|5.25||||0.0005|TWO_SIDED|95.0|2.06|13.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.43|2.06|0.0005
73880259|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|5.62||||0.0003|TWO_SIDED|95.0|2.2|14.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.39|2.20|0.0003
74095364|NCT02906930|147740482|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.13||||0.0001|TWO_SIDED|95.0|0.04|0.36||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.36|0.04|0.0001
74095365|NCT02906930|147740482|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.06||||0.0001|TWO_SIDED|95.0|0.01|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg /Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.26|0.01|0.0001
73880260|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|8.42|||<|0.0001|TWO_SIDED|95.0|2.99|23.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||23.74|2.99|<0.0001
74015626|NCT04872101|147582328|SUPERIORITY||Risk Difference (RD)|23.7|||<|0.001|TWO_SIDED|95.0|15.1|32.2||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.2|15.1|<0.001
74044831|NCT01224106|147641587|SUPERIORITY|||||||0.0903|||||||Mixed Models Analysis|||"Statistical analysis of the t-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0903
74044832|NCT01224106|147641587|SUPERIORITY|||||||0.0434|||||||Mixed Models Analysis|||"Statistical analysis of the t-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0434
74044833|NCT02019758|147641606|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||The mean post-treatment maximum eosinophil count will be compared between the OVB and MDI groups using a two-sample t-test.||||0.31
74044834|NCT02019758|147641607|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||The mean DSQ scores will be compared between the OVB and MDI groups using a two-sample t-test.||||0.70
74044835|NCT02019758|147641612|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.52|2.08||||||||2.08|0.52|
74044836|NCT02019758|147641613|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74044837|NCT02019758|147641614|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74044838|NCT02019758|147641615|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74044839|NCT00446797|147641616|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To conclude non inferiority, the lower bound of the 2-sided 95% confidence interval of the difference in change scores between the 2 treatment groups (nsNSAIDs - celecoxib) must be greater than -10 mm.|Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|2.11||||95.0|-0.76|7.55|||ANCOVA|Terms for treatment, country (fixed), and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Least squares mean||7.55|-0.76|
74095366|NCT01155024|147740508|NON_INFERIORITY_OR_EQUIVALENCE|10 participants required to detect one value change in rating for the SCS scale, with 80% power.|||||>|0.4||95.0||||Two-Sided|t-test, 2 sided|||Alpha level of 0.05||||>0.4
74095367|NCT00894738|147740563|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The null hypothesis is that mean DEXA total percent fat is similar between the two groups of interest. The primary statistical model consisted of treatment group as a 2-level factor (AP-Treated Vs Non-AP Treated) and DEXA total percent fat as a covariate. Carotid intima-media thickness (CIMT) was the dependent variable.||||0.49
74095368|NCT00894738|147740564|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The statistical analysis consisted of treatment group as a 2-level factor variable and DEXA total percent fat as a covariate. An interaction term between treatment group and DEXA total percent fat was also generated. Hepatic triglyceride content was the dependent variable. DEXA total percent fat was found to be significant while treatment group and the interaction between treatment group and DEXA total percent fat were not significant.||||<0.0001
74044840|NCT00446797|147641617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|2.02||||95.0|-0.89|7.08|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||7.08|-0.89|
74044841|NCT00446797|147641617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.46|STANDARD_ERROR_OF_MEAN|2.04||||95.0|-0.55|7.48|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||7.48|-0.55|
74044842|NCT00446797|147641617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|1.86||||95.0|-0.91|6.42|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||6.42|-0.91|
74044843|NCT00446797|147641618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1591||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 2||||0.1591
74044844|NCT00446797|147641618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3995||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 3||||0.3995
74044845|NCT00446797|147641618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6805||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 7||||0.6805
74015627|NCT04872101|147582329|SUPERIORITY||Risk Difference (RD)|29.0|||<|0.001|TWO_SIDED|95.0|21.3|36.7||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||36.7|21.3|<0.001
74044846|NCT00446797|147641619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2411||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2||||0.2411
74015628|NCT04872101|147582330|SUPERIORITY||Risk Difference (RD)|18.3|||<|0.001|TWO_SIDED|95.0|11.0|25.6||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||25.6|11.0|<0.001
74044847|NCT00446797|147641619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1163||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3||||0.1163
74044848|NCT00446797|147641619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7||||0.0440
74044849|NCT00446797|147641620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7223||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3||||0.7223
74015629|NCT04872101|147582331|SUPERIORITY||Risk Difference (RD)|6.6||||0.031|TWO_SIDED|95.0|1.1|12.0||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||12.0|1.1|0.031
74015630|NCT04872101|147582332|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.001|TWO_SIDED|95.0|17.5|32.5||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.5|17.5|<0.001
74044850|NCT00446797|147641620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0541||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7||||0.0541
74044851|NCT00446797|147641621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 2||||0.2900
74044852|NCT00446797|147641621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0157||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3||||0.0157
74044853|NCT00446797|147641621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1206||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7||||0.1206
74044854|NCT00446797|147641622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2||||0.0846
74044855|NCT00446797|147641622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3041||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3||||0.3041
74044856|NCT00446797|147641622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1216||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7||||0.1216
74044857|NCT00446797|147641623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.24||0.395||95.0|-0.33|0.62||Overall p-value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.62|-0.33|0.395
74044858|NCT00446797|147641623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.22||0.004||95.0|0.18|1.04||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||1.04|0.18|0.004
74044859|NCT00446797|147641623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.22||0.122||95.0|-0.08|0.77||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.77|-0.08|0.122
74044860|NCT00446797|147641624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.21||0.604||95.0|-0.32|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.49|-0.32|0.604
74095369|NCT01383135|147740569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||||||GraphPad (GraphPad Software, San Diego, Calif) was used for the paired two-sample t test and was performed to compare SUVmax values. P \< .05 was considered to indicate a significant difference|t-test, 2 sided|||Comparison made between baseline tumor values and tumor values 6-weeks post-bevacizumab therapy||||.034
74015631|NCT04872101|147582333|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.001|TWO_SIDED|95.0|10.2|23.7||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||23.7|10.2|<0.001
74015632|NCT04872101|147582334|SUPERIORITY||Risk Difference (RD)|26.0|||<|0.001|TWO_SIDED|95.0|17.0|35.1||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.1|17.0|<0.001
74015633|NCT04872101|147582335|SUPERIORITY||Risk Difference (RD)|29.6|||<|0.001|TWO_SIDED|95.0|21.7|37.4||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||37.4|21.7|<0.001
74015634|NCT04872101|147582336|SUPERIORITY||Risk Difference (RD)|20.5|||<|0.001|TWO_SIDED|95.0|13.1|27.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||27.8|13.1|<0.001
74015635|NCT04872101|147582337|SUPERIORITY||Risk Difference (RD)|22.2|||<|0.001|TWO_SIDED|95.0|15.4|29.0||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.0|15.4|<0.001
74095370|NCT03397771|147740592|OTHER||Odds Ratio (OR)|1.0||||0.963|TWO_SIDED||||||Regression, Logistic|||||||0.963
74095371|NCT03397771|147740593|NON_INFERIORITY|The analysis was conducted according to the nul hypothesis, assuming no difference between treatment arms||||||0.022|||||||ANCOVA|||||||0.022
74015636|NCT04872101|147582338|SUPERIORITY||Risk Difference (RD)|31.3|||<|0.001|TWO_SIDED|95.0|23.1|39.5||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||39.5|23.1|<0.001
74015637|NCT04872101|147582339|SUPERIORITY||Risk Difference (RD)|31.0|||<|0.001|TWO_SIDED|95.0|22.7|39.3||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||39.3|22.7|<0.001
74015638|NCT04872101|147582340|SUPERIORITY||Mean Difference (Net)|-45.5|||<|0.001|TWO_SIDED|95.0|-56.4|-34.6||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HECSI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-34.6|-56.4|<0.001
74095372|NCT04078126|147740594|OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.0179||0.345|TWO_SIDED|95.0|-0.054|0.02|||ANCOVA|||||0.020|-0.054|0.3450
74095373|NCT04078126|147740595|OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.0183||0.3675|TWO_SIDED|95.0|-0.054|0.021|||ANCOVA|||||0.021|-0.054|0.3675
74095374|NCT04078126|147740596|OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.0199||0.7563|TWO_SIDED|95.0|-0.047|0.034|||ANCOVA|||||0.034|-0.047|0.7563
74095375|NCT04078126|147740597|OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.0521||0.5419|TWO_SIDED|95.0|-0.139|0.075|||ANCOVA|||||0.075|-0.139|0.5419
74095376|NCT04078126|147740598|OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|2.334||0.1337|TWO_SIDED|95.0|-8.39|1.18|||ANCOVA|||||1.18|-8.39|0.1337
74095377|NCT04078126|147740599|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|1.269||0.0431|TWO_SIDED|95.0|-5.29|-0.09|||ANCOVA|||||-0.09|-5.29|0.0431
74095378|NCT04078126|147740600|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|1.667||0.3625|TWO_SIDED|95.0|-4.87|1.81|||ANCOVA|||||1.81|-4.87|0.3625
74095379|NCT04078126|147740601|OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.0198||0.0375|TWO_SIDED|95.0|0.003|0.084|||ANCOVA|||||0.084|0.003|0.0375
74015639|NCT04872101|147582341|SUPERIORITY||Mean Difference (Net)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.0|-2.8||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline DLQI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-2.8|-5.0|<0.001
74015640|NCT04872101|147582342|SUPERIORITY||Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.4|-1.4||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.4|-2.4|<0.001
74015641|NCT04872101|147582343|SUPERIORITY||Median Difference (Net)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD itch score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.4|-2.5|<0.001
74015642|NCT04872101|147582344|SUPERIORITY||Mean Difference (Net)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.6|-1.5||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD pain score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.5|-2.6|<0.001
74015643|NCT04872101|147582345|SUPERIORITY||Median Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-0.99|-0.62||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.62|-0.99|<0.001
74015644|NCT04872101|147582346|SUPERIORITY||Mean Difference (Net)|-0.82|||<|0.001|TWO_SIDED|95.0|-1.01|-0.62||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS PDAL score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.62|-1.01|<0.001
74015645|NCT04872101|147582347|SUPERIORITY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|17.0|35.9||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.9|17.0|<0.001
74015646|NCT03354663|147582353|OTHER|Single arm trial|Proportion|0.047|||<|0.0001|ONE_SIDED|95.0||0.0864|||Binomial Exact Test|||"The hypothesis is formally expressed as:~H0: P ≥ 16.2% Ha: P \< 16.2%, where P is the percentage of subjects with a primary safety endpoint event. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level."||0.0864||<0.0001
74015647|NCT03354663|147582354|OTHER|"The hypothesis is formally expressed as:~H0: P \< 90% Ha: P ≥ 90%, where P is the percentage of subjects with acute success. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level. Rejection of the null hypothesis will indicate study success."|Proportion|0.98||||0.0001|ONE_SIDED|95.0|0.9495||||Binomial Exact Test||||||0.9495|0.0001
74015648|NCT03354663|147582359|OTHER||Kaplan-Meier Survival Estimate|82.2|||||TWO_SIDED|95.0|74.7|87.6|||||Kaplan-Meier estimate of freedom from recurrence at 1-year|Kaplan Meier Estimate of freedom from recurrence.||87.6|74.7|
74015649|NCT03354663|147582360|OTHER||Kaplan-Meier survival estimate|68.2|||||TWO_SIDED|95.0|59.9|75.1||||||Kaplan-Meier estimate of freedom from recurrence or need for anti-arrhythmic medication||75.1|59.9|
74015650|NCT03691974|147582374|SUPERIORITY||Least Square (LS) Mean Difference|0.4||||0.4192|TWO_SIDED|95.0|-0.55|1.32||Analyses are based on Mixed Model for Repeated Measures (MMRM) model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|Mixed Model for Repeated Measures (MMRM)|||||1.32|-0.55|0.4192
74015651|NCT03691974|147582375|SUPERIORITY||LS Mean Difference|0.4||||0.0521|TWO_SIDED|95.0|0.0|0.8||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||0.80|-0.00|0.0521
74044861|NCT00446797|147641624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|0.18||0.124||95.0|-0.07|0.63||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.63|-0.07|0.124
74044862|NCT00446797|147641624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.15||0.062||95.0|0.03|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.61|0.03|0.062
74015652|NCT03691974|147582376|SUPERIORITY||LS Mean Difference|1.3||||0.1593|TWO_SIDED|95.0|-0.52|3.15||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||3.15|-0.52|0.1593
74015653|NCT03691974|147582377|SUPERIORITY||LS Mean Difference|-0.2||||0.7757|TWO_SIDED|95.0|-1.59|1.19||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.19|-1.59|0.7757
74015654|NCT03691974|147582378|SUPERIORITY||LS Mean Difference|-0.4||||0.6063|TWO_SIDED|95.0|-1.87|1.09||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.09|-1.87|0.6063
74015655|NCT03691974|147582379|SUPERIORITY||LS Mean Difference|-1.0||||0.4203|TWO_SIDED|95.0|-3.3|1.39||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.39|-3.30|0.4203
74015656|NCT03691974|147582380|SUPERIORITY||LS Mean Difference|-1.33||||0.001|TWO_SIDED|95.0|-2.123|-0.538||Analyses are based on multiple imputation with MMRM model with terms for baseline WOMAC subscale score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||-0.538|-2.123|0.0010
74015657|NCT03691974|147582381|SUPERIORITY||LS Mean Difference|-1.42||||0.0005|TWO_SIDED|95.0|-2.212|-0.625||Analyses were based on multiple imputation with MMRM model with terms for baseline WOMAC subscale score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||-0.625|-2.212|0.0005
74015658|NCT01661140|147582391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority if the difference between treatments is statistically significant and the lower limit of the 95% confidence interval (CI) is greater than 0.9.|Odds Ratio (OR)|1.803||||0.036|TWO_SIDED|95.0|1.037|3.133|||Analysis by logistic regression|||Comparison was Tapering MTX : MTX maintenance. Last post-baseline EULAR response recorded used for participants with a missing result at Week 60.||3.133|1.037|0.036
74015659|NCT00883337|147582437|SUPERIORITY_OR_OTHER|||||||0.5953||95.0||||"Hochberg testing procedure:~* a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~* a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value \>0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"The study was sized to detect a difference between Teriflunomide and Rebif groups in the time to failure at a significance level of 0.025 with a power of 81%.~Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and Rebif~* H2: No difference between Teriflunomide 7 mg and Rebif"||||0.5953
74015660|NCT00883337|147582437|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||"Hochberg testing procedure:~* a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~* a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value \>0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and Rebif~* H2: No difference between Teriflunomide 7 mg and Rebif"||||0.5190
74015661|NCT03468309|147582455|SUPERIORITY|T-test was used to compare means at baseline and 12-weeks|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74015662|NCT03468309|147582456|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74015663|NCT03468309|147582457|SUPERIORITY||||||<|0.05|||||||ANOVA|Assumption of sphericity had been violated X2(2)=13.61, p\<.01 so Huynh-Feldt correction was used||||||<0.05
74015664|NCT03468309|147582458|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74015665|NCT05726318|147582506|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
74015666|NCT05726318|147582508|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
74015667|NCT05726318|147582509|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||.68
74015668|NCT05726318|147582511|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
74015669|NCT05726318|147582512|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
74044863|NCT00446797|147641625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.21||0.705||95.0|-0.36|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.47|-0.36|0.705
74044864|NCT00446797|147641625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.19||0.064||95.0|-0.01|0.73||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.73|-0.01|0.064
74044865|NCT00446797|147641625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.074||95.0|-0.01|0.68||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.68|-0.01|0.074
74044866|NCT00446797|147641626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.24||0.017||95.0|0.11|1.05||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||1.05|0.11|0.017
74044867|NCT00446797|147641626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.2||0.108||95.0|-0.05|0.74||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.74|-0.05|0.108
73888042|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.1778|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.1|-0.4|0.1778
74015670|NCT01485627|147582513|SUPERIORITY||Adjusted mean difference in difference|0.34||||0.05|TWO_SIDED|95.0|0.06|0.62|||Mixed Models Analysis||Models included fixed-effects terms for phase (pre- vs postrandomization), study arm, and the Phase\*Arm interaction. Estimated effect is the between-arm difference in adjusted mean difference from prerandomization to postrandomization samples.|The primary outcome was a composite of 4 prespecified communication measures matched to the goals of communication training, as follows: Active Patient Participation Coding \[APPC\], Verona VR-CoDES, Prognostic and Treatment Choices \[PTCC\] Informing subscale, and PTCC Balanced Framing subscale. The 4 measures were z-score transformed and averaged to produce the composite measure.||0.62|0.06|0.05
73880261|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0277|TWO_SIDED|95.0|1.12|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.70|1.12|0.0277
74015671|NCT01485627|147582514|SUPERIORITY|||||||0.214|||||||Mixed Models Analysis|||||||0.214
74015672|NCT01485627|147582515|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.05|TWO_SIDED|95.0|-0.56|0.37|||Mixed Models Analysis|||||0.37|-0.56|0.05
74015673|NCT01485627|147582517|SUPERIORITY|||||||0.677|||||||Mixed Models Analysis|||||||0.677
74015674|NCT01485627|147582518|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
74015675|NCT04589988|147582519|SUPERIORITY|||||||0.068||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.068
74015676|NCT04589988|147582520|SUPERIORITY|||||||0.063||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.063
74044868|NCT00446797|147641626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.17||0.117||95.0|-0.01|0.66||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.66|-0.01|0.117
74044869|NCT00446797|147641627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.2||0.229||95.0|-0.17|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.60|-0.17|0.229
74044870|NCT00446797|147641627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.18||0.027||95.0|0.05|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.75|0.05|0.027
74044871|NCT00446797|147641627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.07||95.0|0.01|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.65|0.01|0.070
74044872|NCT00446797|147641628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.3||0.954||95.0|-0.64|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.53|-0.64|0.954
74044873|NCT00446797|147641628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.31||0.172||95.0|-0.19|1.02||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||1.02|-0.19|0.172
74044874|NCT00446797|147641628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.24||0.541||95.0|-0.3|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.62|-0.30|0.541
74044875|NCT00446797|147641629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.34||0.924||95.0|-0.75|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.58|-0.75|0.924
74044876|NCT00446797|147641629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.29||0.898||95.0|-0.62|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.51|-0.62|0.898
74044877|NCT00446797|147641629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.24||0.655||95.0|-0.33|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.60|-0.33|0.655
74015677|NCT04589988|147582521|SUPERIORITY|||||||0.724||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.724
74015678|NCT04589988|147582522|SUPERIORITY|||||||0.447||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.447
74044878|NCT00446797|147641630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.31||0.929||95.0|-0.59|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.62|-0.59|0.929
74044879|NCT00446797|147641630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.3||0.712||95.0|-0.5|0.71||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.71|-0.50|0.712
74095380|NCT04078126|147740602|OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.0443||0.9089|TWO_SIDED|95.0|-0.086|0.096|||ANCOVA|||||0.096|-0.086|0.9089
74015679|NCT04589988|147582523|SUPERIORITY|||||||0.696||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, work status, and depression score at baseline.||||0.696
74044880|NCT00446797|147641630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.24||0.993||95.0|-0.44|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.51|-0.44|0.993
74044881|NCT00446797|147641631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.32||0.779||95.0|-0.53|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.75|-0.53|0.779
74044882|NCT00446797|147641631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.34||0.972||95.0|-0.69|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.65|-0.69|0.972
74044883|NCT00446797|147641631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.27||0.844||95.0|-0.47|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.61|-0.47|0.844
74044884|NCT00446797|147641632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.31||0.944||95.0|-0.63|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.60|-0.63|0.944
74044885|NCT00446797|147641632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.654||95.0|-0.62|0.38||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.38|-0.62|0.654
74044886|NCT00446797|147641632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.952||95.0|-0.36|0.39||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.39|-0.36|0.952
74044887|NCT00446797|147641633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.31||0.842||95.0|-0.65|0.59||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.59|-0.65|0.842
74044888|NCT00446797|147641633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.828||95.0|-0.57|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.49|-0.57|0.828
74095381|NCT03056157|147740603|SUPERIORITY||Slope|-0.236||||0.03|TWO_SIDED|95.0|-3.34|-0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1519 )= -2.19, d = 0.15.||-0.18|-3.34|0.03
74095382|NCT03056157|147740603|SUPERIORITY||Slope|-8.97|||<|0.001|TWO_SIDED|95.0|-10.12|-6.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to- treat data for SDS scores, t(160)= -15.74, d = 2.97.||-6.11|-10.12|<.001
74095383|NCT03056157|147740603|SUPERIORITY||Slope|-6.62|||<|0.001|TWO_SIDED|95.0|-8.35|-6.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(160) = -12.72, d = 1.86.||-6.11|-8.35|<0.001
74044889|NCT00446797|147641633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.21||0.542||95.0|-0.3|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.53|-0.30|0.542
74044890|NCT00446797|147641634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.34||0.404||95.0|-0.92|0.42||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.42|-0.92|0.404
74044891|NCT00446797|147641634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.28||0.816||95.0|-0.53|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.58|-0.53|0.816
74044892|NCT00446797|147641634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.23||0.837||95.0|-0.37|0.52||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.52|-0.37|0.837
74044893|NCT00446797|147641635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.25||0.887||95.0|-0.54|0.45||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.45|-0.54|0.887
74044894|NCT00446797|147641635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.24||0.889||95.0|-0.43|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.51|-0.43|0.889
74044895|NCT00446797|147641635|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.2||0.738||95.0|-0.3|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.47|-0.30|0.738
74044896|NCT04211961|147641673|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
74095384|NCT03056157|147740603|SUPERIORITY||Slope|-0.65||||0.49|TWO_SIDED|95.0|-2.13|0.86|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = -0.90, d = 0.05.||0.86|-2.13|0.49
74044897|NCT04211961|147641674|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
74044898|NCT04211961|147641675|SUPERIORITY|||||||0.3|||||||Fisher Exact|||||||0.3
74044899|NCT04211961|147641676|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
74044900|NCT04211961|147641678|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
74044901|NCT04211961|147641679|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
74044902|NCT04211961|147641680|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
74044903|NCT04211961|147641682|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
74044904|NCT04211961|147641683|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
74044905|NCT04211961|147641684|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
74044906|NCT04211961|147641685|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
74044907|NCT04211961|147641686|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
74095385|NCT03056157|147740603|SUPERIORITY||Slope|1.1|||<|0.001|TWO_SIDED|95.0|0.06|2.17|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = 2.11, d = 0.11.||2.17|0.06|<0.001
74095386|NCT03056157|147740603|SUPERIORITY||Slope|1.75|||<|0.001|TWO_SIDED|95.0|0.75|2.81|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = 3.45, d = 0.18||2.81|0.75|<0.001
74095387|NCT03056157|147740604|SUPERIORITY||Odds Ratio (OR)|2.35||||0.03|TWO_SIDED|95.0|1.01|5.56|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced probable recovery in SDS from baseline to post-treatment in AD-MIL versus PCT.||5.56|1.01|0.03
74095388|NCT03056157|147740604|SUPERIORITY||Odds Ratio (OR)|0.0||||0.01|TWO_SIDED|95.0|0.0|0.71|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced improvement from baseline to post-treatment in SDS in AD-MIL versus PCT.||0.71|0|0.01
74095389|NCT03056157|147740604|SUPERIORITY||Odds Ratio (OR)|0.82||||0.69|TWO_SIDED|95.0|0.35|1.87|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced no change in SDS from baseline to post-treatment in AD-MIL versus PCT.||1.87|0.35|.69
74095390|NCT03056157|147740604|SUPERIORITY||Odds Ratio (OR)|0.0||||0.5|TWO_SIDED|0.0|0.0|5.83|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced deterioration in SDS from baseline to post-treatment in AD-MIL versus PCT.||5.83|0|0.50
74095391|NCT03056157|147740605|SUPERIORITY||Slope|-3.39||||0.35|TWO_SIDED|95.0|-10.57|3.79|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -0.93, d = 0.10.||3.79|-10.57|0.35
74095392|NCT03056157|147740605|SUPERIORITY||Slope|-8.64||||0.001|TWO_SIDED|95.0|-13.83|-3.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for BIPF scores, t(116) = -3.27, d = 0.61.||-3.44|-13.83|0.001
74095393|NCT03056157|147740605|SUPERIORITY||Slope|-5.25||||0.04|TWO_SIDED|95.0|-10.21|-0.29|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(116) = -2.08, d = 0.39.||-0.29|-10.21|0.04
74095394|NCT03056157|147740605|SUPERIORITY||Slope|-5.17||||0.08|TWO_SIDED|95.0|-10.86|0.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -1.79, d = 0.20.||0.52|-10.86|0.08
73880262|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0022|TWO_SIDED|95.0|1.66|10.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.32|1.66|0.0022
74095395|NCT03056157|147740605|SUPERIORITY||Slope|-5.64||||0.007|TWO_SIDED|95.0|-9.72|-1.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -2.72, d = 0.30.||-1.57|-9.72|0.007
74095396|NCT03056157|147740605|SUPERIORITY||Slope|-0.47||||0.82|TWO_SIDED|95.0|-4.44|3.5|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -0.23, d = 0.03.||3.50|-4.44|0.82
74095397|NCT03056157|147740606|SUPERIORITY||Slope|-0.6||||0.75|TWO_SIDED|95.0|-4.68|3.36|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = -0.32, d = 0.03.||3.36|-4.68|0.75
74095398|NCT03056157|147740606|SUPERIORITY||Slope|-9.12|||<|0.001|TWO_SIDED|95.0|-12.12|-6.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(37) = -6.01, d = 1.97.||-6.12|-12.12|<0.001
74095399|NCT03056157|147740606|SUPERIORITY||Slope|-8.72|||<|0.001|TWO_SIDED|95.0|-11.16|-5.76|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(37) = -6.11, d = 2.01.||-5.76|-11.16|<0.001
74095400|NCT03056157|147740606|SUPERIORITY||Slope|-2.28||||0.56|TWO_SIDED|95.0|-10.08|5.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = -0.59, d = 0.06.||5.52|-10.08|0.56
74095401|NCT03056157|147740606|SUPERIORITY||Slope|4.2||||0.22|TWO_SIDED|95.0|-0.24|10.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = 1.25, d = 0.13.||10.92|-0.24|0.22
74095402|NCT03056157|147740606|SUPERIORITY||Slope|6.6||||0.002|TWO_SIDED|95.0|2.52|10.69|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = 3.18, d = 0.33.||10.69|2.52|0.002
74095403|NCT03056157|147740607|SUPERIORITY||Slope|0.48||||0.92|TWO_SIDED|95.0|-9.6|10.69|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(367) = 0.10, d = 0.01.||10.69|-9.60|0.92
74095404|NCT03056157|147740607|SUPERIORITY||Slope|-16.08|||<|0.001|TWO_SIDED|95.0|-23.64|-8.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -4.23, d = 1.39.||-8.52|-23.64|<0.001
74095405|NCT03056157|147740607|SUPERIORITY||Slope|-16.56|||<|0.001|TWO_SIDED|95.0|-23.4|-9.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -4.77, d = 1.57.||-9.72|-23.40|<0.001
74095406|NCT03056157|147740607|SUPERIORITY||Slope|-26.28||||0.002|TWO_SIDED|95.0|-42.6|-9.84|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(367) = -3.15, d = 0.33.||-9.84|-42.60|0.002
74095407|NCT03056157|147740607|SUPERIORITY||Slope|-18.72||||0.01|TWO_SIDED|95.0|-32.4|-4.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -2.67, d = 0.28.||-4.92|-32.40|0.01
74095408|NCT03056157|147740607|SUPERIORITY||Slope|-5.25||||0.04|TWO_SIDED|95.0|-10.21|-0.29|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B- IPF scores, the Pre-Post PCT Time slope was -5.25 \[95% CI = -10.21, -0.29\], p-value = 0.04, t(116) = -2.08, d = 0.39.||-0.29|-10.21|0.04
74044908|NCT02498392|147641697|SUPERIORITY||Difference of Least Square (LS) Means|-0.2|STANDARD_ERROR_OF_MEAN|1.04|=|0.416|TWO_SIDED|60.0|-1.1|0.66|||Mixed-effects Model for Repeated Measure|||||0.66|-1.10|= 0.416
74044909|NCT02498392|147641698|SUPERIORITY||Difference of Least Square (LS) Means|0.3|STANDARD_ERROR_OF_MEAN|0.88|=|0.647|TWO_SIDED|60.0|-0.41|1.07||1-sided|Mixed-effects Model for Repeated Measure|||||1.07|-0.41|= 0.647
74044910|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.9825|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.9825
74044911|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.5737|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5737
74044912|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.5703|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5703
74044913|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.5684|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5684
74044914|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.8235|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.8235
74044915|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.2384|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.2384
74044916|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.1634|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.1634
74044917|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.7816|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.7816
74044918|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.3917|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.3917
74044919|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.1749|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.1749
74044920|NCT01156363|147641732|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||<0.001
74095409|NCT03056157|147740608|SUPERIORITY||Slope|-6.38||||0.1|TWO_SIDED|95.0|-13.97|1.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = -1.69, d = 0.48.||1.22|-13.97|0.10
74044921|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.0905|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.0905
74044922|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.3766|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.3766
74044923|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.0253|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.0253
74044924|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.0209|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.0209
74044925|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.8206|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.8206
74044926|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.0907|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0907
74044927|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0177
74044928|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0050
74044929|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.3724|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.3724
74044930|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.2796|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.2796
74044931|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.0066
74044932|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.0081
74044933|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.7853|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.7853
74044934|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.0039
74044935|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.3057|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.3057
74044936|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.3374|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.3374
74044937|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.141|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.1410
74044938|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0017
74044939|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.0677|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0677
74044940|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.1608|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.1608
74044941|NCT01156363|147641732|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0196
74044942|NCT04080752|147641744|SUPERIORITY||Least Square (LS) Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.897||0.2494|TWO_SIDED|80.0|-1.76|0.55|||Mixed Model for Repeated Measures (MMRM)|||||0.55|-1.76|0.2494
74095410|NCT03056157|147740608|SUPERIORITY||Slope|-13.29|||<|0.001|TWO_SIDED|95.0|-18.96|-7.62|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(32) = -4.71, d = 1.67.||-7.62|-18.96|<0.001
74095411|NCT03056157|147740608|SUPERIORITY||Slope|-6.92||||0.001|TWO_SIDED|95.0|-11.96|-1.87|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(32) = -2.75, d = 0.97.||-1.87|-11.96|0.001
74044943|NCT01641081|147641850|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2644|STANDARD_ERROR_OF_MEAN|0.0148|<|0.0001|TWO_SIDED|95.0|0.2353|0.2934|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2934|0.2353|<0.0001
74044944|NCT01641081|147641850|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2524|STANDARD_ERROR_OF_MEAN|0.0156|<|0.0001|TWO_SIDED|95.0|0.2218|0.283|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2830|0.2218|<0.0001
74044945|NCT01641081|147641850|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2242|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.1941|0.2544|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2544|0.1941|<0.0001
74044946|NCT01641081|147641850|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2174|STANDARD_ERROR_OF_MEAN|0.0146|<|0.0001|TWO_SIDED|95.0|0.1887|0.2461|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2461|0.1887|<0.0001
74095412|NCT03056157|147740608|SUPERIORITY||Slope|5.22||||0.34|TWO_SIDED|95.0|-5.6|16.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 0.97, d = 0.28.||16.05|-5.60|0.34
74095413|NCT03056157|147740608|SUPERIORITY||Slope|5.93||||0.17|TWO_SIDED|95.0|-2.55|14.41|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 1.40, d = 0.40.||14.41|-2.55|0.17
74095414|NCT03056157|147740608|SUPERIORITY||Slope|0.7||||0.83|TWO_SIDED|95.0|-6.04|7.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 0.21, d = 0.06.||7.44|-6.04|0.83
74095415|NCT03056157|147740609|SUPERIORITY||Slope|0.6||||0.76|TWO_SIDED|95.0|-3.12|4.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = 0.30, d = 0.03.||4.20|-3.12|0.76
74095416|NCT03056157|147740609|SUPERIORITY||Slope|-3.12||||0.002|TWO_SIDED|95.0|-6.96|-1.56|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(37) = -3.14, d = 1.03.||-1.56|-6.96|0.002
74095417|NCT03056157|147740609|SUPERIORITY||Slope|-4.92|||<|0.001|TWO_SIDED|95.0|-7.32|-2.4|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(37) = -3.88, d = 1.27.||-2.40|-7.32|<0.001
74095418|NCT03056157|147740609|SUPERIORITY||Slope|-4.8||||0.13|TWO_SIDED|95.0|-11.16|1.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = -1.50, d = 0.16.||1.44|-11.16|0.13
74095419|NCT03056157|147740609|SUPERIORITY||Slope|-2.4||||0.38|TWO_SIDED|95.0|-7.68|3.0|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = -0.87, d = 0.09.||3.00|-7.68|0.38
74044947|NCT01095666|147641852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.0869|<|0.0001|TWO_SIDED|95.0|-0.76|-0.42||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment.|ANCOVA|||||-0.42|-0.76|<0.0001
74044948|NCT01095666|147641852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.0865|<|0.0001|TWO_SIDED|95.0|-0.79|-0.45||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment.|ANCOVA|||||-0.45|-0.79|<0.0001
74044949|NCT01095666|147641853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|3.299|<|0.0001|TWO_SIDED|95.0|-28.6|-15.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-15.6|-28.6|<0.0001
74044950|NCT01095666|147641853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.1|STANDARD_ERROR_OF_MEAN|3.271|<|0.0001|TWO_SIDED|95.0|-33.5|-20.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-20.7|-33.5|<0.0001
74095420|NCT03056157|147740609|SUPERIORITY||Slope|2.4||||0.26|TWO_SIDED|95.0|-0.96|5.88|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = 1.42, d = 0.15.||5.88|-0.96|0.26
74044951|NCT01095666|147641854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.3|STANDARD_ERROR_OF_MEAN|5.8758|<|0.0001|TWO_SIDED|95.0|-53.84|-30.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-30.73|-53.84|<0.0001
74044952|NCT01095666|147641854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.1|STANDARD_ERROR_OF_MEAN|5.7921|<|0.0001|TWO_SIDED|95.0|-60.53|-37.74||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-37.74|-60.53|<0.0001
74095421|NCT03056157|147740610|SUPERIORITY||Slope|-6.65|||<|0.001|TWO_SIDED|95.0|-10.23|-3.07|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = -3.65, d = 0.39.||-3.07|-10.23|<0.001
74095422|NCT03056157|147740610|SUPERIORITY||Slope|-11.88|||<|0.001|TWO_SIDED|95.0|-14.43|-9.32|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(131) = -9.14, d = 1.60.||-9.32|-14.43|<0.001
74095423|NCT03056157|147740610|SUPERIORITY||Slope|-5.23|||<|0.001|TWO_SIDED|95.0|-7.74|-2.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(131) = -4.10, d = 0.72.||-2.72|-7.74|<0.001
74095424|NCT03056157|147740610|SUPERIORITY||Slope|1.36||||0.39|TWO_SIDED|95.0|-1.73|4.45|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = 0.87, d = 0.09.||4.45|-1.73|0.39
74095425|NCT03056157|147740610|SUPERIORITY||Slope|0.08||||0.94|TWO_SIDED|95.0|-2.1|2.26|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = 0.07, d = 0.001.||2.26|-2.10|0.94
74095426|NCT03056157|147740610|SUPERIORITY||Slope|-1.28||||0.25|TWO_SIDED|95.0|-3.48|0.91|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = -1.15, d = 0.12.||0.91|-3.48|0.25
74095427|NCT03056157|147740611|SUPERIORITY||Odds Ratio (OR)|6.44||||0.01|TWO_SIDED|95.0|1.29|63.18|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced probable recovery in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||63.18|1.29|0.01
74095428|NCT03056157|147740611|SUPERIORITY||Odds Ratio (OR)|1.51||||0.4|TWO_SIDED|95.0|0.61|3.75|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced improvement in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||3.75|0.61|0.40
74095429|NCT03056157|147740611|SUPERIORITY||Odds Ratio (OR)|0.78||||0.58|TWO_SIDED|95.0|0.36|1.7|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced no change in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||1.70|0.36|0.58
73880263|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0314|TWO_SIDED|95.0|1.26|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.41|1.26|0.0314
73880264|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0041|TWO_SIDED|95.0|1.54|9.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.97|1.54|0.0041
73880265|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.19||||0.0028|TWO_SIDED|95.0|1.64|10.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.74|1.64|0.0028
73880266|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.96||||0.0011|TWO_SIDED|95.0|1.9|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.98|1.90|0.0011
73880267|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|8.79||||0.0001|TWO_SIDED|95.0|2.86|26.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||26.99|2.86|0.0001
73880268|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.09||||0.0036|TWO_SIDED|95.0|1.59|10.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.57|1.59|0.0036
73880269|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.52||||0.0018|TWO_SIDED|95.0|1.75|11.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.67|1.75|0.0018
73880270|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0243|TWO_SIDED|95.0|1.14|6.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.68|1.14|0.0243
74015680|NCT04589988|147582524|SUPERIORITY|||||||0.798||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.798
74015681|NCT04589988|147582525|SUPERIORITY|||||||0.135||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.135
74044953|NCT01095666|147641855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.2765|<|0.0001|TWO_SIDED|95.0|-1.65|-0.56||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-0.56|-1.65|<0.0001
74044954|NCT01095666|147641855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|0.2747|<|0.0001|TWO_SIDED|95.0|-2.36|-1.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-1.28|-2.36|<0.0001
74095430|NCT03056157|147740611|SUPERIORITY||Odds Ratio (OR)|0.15||||0.06|TWO_SIDED|95.0|0.003|1.2|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced deterioration in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||1.20|0.003|0.06
73880271|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.33||||0.077|TWO_SIDED|95.0|0.91|5.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.96|0.91|0.0770
74044955|NCT01095666|147641856|SUPERIORITY_OR_OTHER||Difference in percentage|15.4|STANDARD_ERROR_OF_MEAN|4.702||0.001|TWO_SIDED|95.0|6.2|24.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c||||24.7|6.2|0.0010
73880272|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.61||||0.0451|TWO_SIDED|95.0|1.02|6.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.69|1.02|0.0451
74044956|NCT01095666|147641856|SUPERIORITY_OR_OTHER||Difference in percentage|15.5|STANDARD_ERROR_OF_MEAN|4.594||0.0007|TWO_SIDED|95.0|6.5|24.5||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c||||24.5|6.5|0.0007
74095431|NCT03056157|147740612|SUPERIORITY||Odds Ratio (OR)|0.49||||0.07|TWO_SIDED|95.0|0.22|1.06|||Fisher Exact|||Odds ratio comparison of the proportions of participants with a PTSD Diagnosis in CAPS-5 at post-treatment in AD-MIL versus PCT.||1.06|0.22|0.07
73880273|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0165|TWO_SIDED|95.0|1.25|9.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.04|1.25|0.0165
74095432|NCT03056157|147740612|SUPERIORITY||Odds Ratio (OR)|0.66||||0.33|TWO_SIDED|95.0|0.28|1.56|||Fisher Exact|||Odds ratio comparison of the proportions of participants with PTSD Diagnosis in CAPS-5 at 3MFU in AD-MIL versus PCT.||1.56|0.28|0.33
74095433|NCT03056157|147740612|SUPERIORITY||Odds Ratio (OR)|0.42||||0.05|TWO_SIDED|95.0|0.15|1.08|||Fisher Exact|||Odds ratio comparison of the proportions of participants with PTSD Diagnosis in CAPS-5 at 6MFU in AD-MIL versus PCT.||1.08|0.15|0.05
74095434|NCT03056157|147740613|SUPERIORITY||Slope|-4.63||||0.003|TWO_SIDED|95.0|-7.16|-2.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = -3.01, d = 0.13.||-2.10|-7.16|.003
74095435|NCT03056157|147740613|SUPERIORITY||Slope|-12.62|||<|0.001|TWO_SIDED|95.0|-14.43|-10.8|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(161) = -11.50, d = 1.81.||-10.80|-14.43|<0.001
74095436|NCT03056157|147740613|SUPERIORITY||Slope|-7.89|||<|0.001|TWO_SIDED|95.0|-9.77|-6.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(161) = -7.40, d = 1.16.||-6.20|-9.77|<0.001
74095437|NCT03056157|147740613|SUPERIORITY||Slope|-0.75||||0.65|TWO_SIDED|95.0|-4.01|2.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = -0.45, d = 0.02.||2.52|-4.01|0.65
74095438|NCT03056157|147740613|SUPERIORITY||Slope|2.3||||0.05|TWO_SIDED|95.0|-0.03|4.63|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = 1.94, d = 0.10.||4.63|-0.03|0.05
74095439|NCT03056157|147740613|SUPERIORITY||Slope|3.04||||0.001|TWO_SIDED|95.0|0.75|5.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = 2.61, d = 0.13.||5.34|0.75|0.001
74095440|NCT03056157|147740614|SUPERIORITY||Odds Ratio (OR)|2.39||||0.04|TWO_SIDED|95.0|1.01|5.84|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing probable recovery in PCL-5 at post-treatment in AD-MIL versus PCT.||5.84|1.01|0.04
74095441|NCT03056157|147740614|SUPERIORITY||Odds Ratio (OR)|0.7||||0.49|TWO_SIDED|95.0|0.25|1.95|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing improvement in PCL-5 at post-treatment in AD-MIL versus PCT.||1.95|0.25|0.49
74095442|NCT03056157|147740614|SUPERIORITY||Odds Ratio (OR)|0.58||||0.18|TWO_SIDED|95.0|0.25|1.32|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing no change in PCL-5 at post-treatment in AD-MIL versus PCT.||1.32|0.25|0.18
74095443|NCT03056157|147740615|SUPERIORITY||Slope|-0.99||||0.14|TWO_SIDED|95.0|-2.29|0.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = -1.46, d = 0.07||0.34|-2.29|0.14
74095444|NCT03056157|147740615|SUPERIORITY||Slope|-5.87|||<|0.001|TWO_SIDED|95.0|-6.8|-4.9|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(161) = -12.41, d = 1.96.||-4.90|-6.80|<0.001
74095445|NCT03056157|147740615|SUPERIORITY||Slope|-4.89|||<|0.001|TWO_SIDED|95.0|-5.82|-3.94|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(161) = -10.29, d = 1.62.||-3.94|-5.82|<0.001
74095446|NCT03056157|147740615|SUPERIORITY||Slope|0.02||||0.68|TWO_SIDED|95.0|-0.99|1.53|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 0.42, d = 0.02.||1.53|-0.99|0.68
74095447|NCT03056157|147740615|SUPERIORITY||Slope|1.36||||0.003|TWO_SIDED|95.0|0.48|2.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 3.02, d = 0.15.||2.24|0.48|0.003
74095448|NCT03056157|147740615|SUPERIORITY||Slope|1.09||||0.02|TWO_SIDED|95.0|0.19|1.99|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 2.37, d = 0.12.||1.99|0.19|0.02
74095449|NCT03056157|147740616|SUPERIORITY||Slope|-0.2||||0.18|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(314) = -1.35, d = 0.15.||0.09|-0.49|0.18
74095450|NCT03056157|147740616|SUPERIORITY||Slope|-0.26||||0.02|TWO_SIDED|95.0|-0.47|-0.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -2.44, d = 0.46.||-0.05|-0.47|0.02
74095451|NCT03056157|147740616|SUPERIORITY||Slope|-0.06||||0.62|TWO_SIDED|95.0|-0.26|0.14|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -0.69, d = 0.12.||0.14|-0.26|0.62
73880274|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0037|TWO_SIDED|95.0|1.72|16.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||16.23|1.72|0.0037
73880275|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0812|TWO_SIDED|95.0|0.9|5.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.82|0.90|0.0812
74095452|NCT03056157|147740616|SUPERIORITY||Slope|0.16||||0.18|TWO_SIDED|95.0|-0.07|0.39|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(314) = 1.34, d = 0.15.||0.39|-0.07|0.18
74095453|NCT03056157|147740616|SUPERIORITY||Slope|0.13||||0.14|TWO_SIDED|95.0|-0.04|0.3|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = 1.49, d = 0.28.||0.30|-0.04|0.14
74095454|NCT03056157|147740616|SUPERIORITY||Slope|-0.03||||0.71|TWO_SIDED|95.0|-0.19|0.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -0.38, d = 0.07.||0.13|-0.19|0.71
74095455|NCT03056157|147740617|SUPERIORITY||Slope|-0.47|||<|0.001|TWO_SIDED|95.0|-0.74|-0.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(314) = -3.41, d = 0.39.||-0.20|-0.74|<0.001
74095456|NCT03056157|147740617|SUPERIORITY||Slope|-0.64|||<|0.001|TWO_SIDED|95.0|-0.83|-0.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -6.41, d = 1.20.||-0.44|-0.83|<0.001
74095457|NCT03056157|147740617|SUPERIORITY||Slope|-0.17||||0.07|TWO_SIDED|95.0|-0.36|0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -1.83, d = 0.34.||0.02|-0.36|0.07
74095458|NCT03056157|147740617|SUPERIORITY||Slope|0.35||||0.002|TWO_SIDED|95.0|0.13|0.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(314) = 3.13, d = 0.06.||0.57|0.13|0.002
74015682|NCT04589988|147582526|SUPERIORITY|||||||0.291||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, work status, and depression score at baseline.||||0.291
74015683|NCT04589988|147582527|SUPERIORITY||Incidence rate ratio|0.83||||0.631|TWO_SIDED|95.0|0.4|1.76|||Negative binomial regression||IRR reflects REBIL intervention group versus control group.|Fall rates were compared between REBIL and control groups using negative binomial regression. The model adjusted for age, sex, ace, and depression score at baseline. The null hypothesis was that fall rates do not differ between groups.||1.76|0.40|0.631
74015684|NCT02264990|147582528|SUPERIORITY|A fixed sequence testing procedure was used for analyses of the primary and secondary efficacy endpoints to control for the familywise error rate. If veliparib plus C/P treatment was not statistically significantly better compared to the investigators' choice of standard therapy for the primary efficacy endpoint of OS in LSP+ participants, then statistical significance would not be declared for any of the secondary efficacy endpoints.|Hazard Ratio (HR)|0.644||||0.113|TWO_SIDED|95.0|0.396|1.048||Statistical significance was determined by a two-sided P value ≤ 0.05.|Log Rank|Log rank test stratified by ECOG performance status, investigators' preferred platinum therapy, and gender.|Hazard ratio obtained using the covariate adjusted Cox Proportional Hazard Model with covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.048|0.396|0.113
74015685|NCT02264990|147582529|OTHER||Hazard Ratio (HR)|0.647||||0.26|TWO_SIDED|95.0|0.388|1.08|||Log Rank|Log-rank test stratified by investigator's preferred platinum therapy, gender, and ECOG performance status.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.080|0.388|0.260
74044957|NCT03011775|147641865|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|The threshold for statistical significance was P value of .05||||||<0.05
74044958|NCT03011775|147641866|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
74044959|NCT03011775|147641868|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
74044960|NCT03011775|147641869|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74044961|NCT03011775|147641871|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74044962|NCT03011775|147641872|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
74044963|NCT03011775|147641873|SUPERIORITY||||||=|0.3|||||||Wilcoxon (Mann-Whitney)|||||||=0.3
74044964|NCT00588380|147641874|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Kruskal-Wallis|||Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of rs6923761 genotype with Phi Total in the presence of either glucose alone, glucose and 0.75 pmol/kg/min GLP-1 or glucose and 1.5 pmol/kg/min GLP-1 If the p-value for the overall univariate test of association was \<0.1, then the associations for specific genotype pairs (e.g.: 1,1 vs. 1,2 or 2,2 vs. 1,1) were also examined using a Mann-Whitney Rank Sum test.||||0.11
74044965|NCT00588380|147641875|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Kruskal-Wallis|||All data are presented as means ± SEM. Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of genotype with ΦTotal||||0.09
74044966|NCT01324687|147641876|SUPERIORITY_OR_OTHER||Rate ratio|0.8387||||0.017|TWO_SIDED|95.0|0.7261|0.9689|||GEE / Poisson regression models|||Rate ratio of ED use rate of the intervention group as compared to the control group.||0.9689|0.7261|0.017
74044967|NCT02917629|147641890|SUPERIORITY||Mean Difference (Final Values)|1.0011|STANDARD_DEVIATION|0.024||0.031|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000229822 baseline and post exposure||||0.031
74044968|NCT02917629|147641890|SUPERIORITY||Mean Difference (Final Values)|-1.0217|STANDARD_DEVIATION|0.0257||0.031|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000230585 baseline and post exposure||||0.031
74044969|NCT02917629|147641890|SUPERIORITY||Mean Difference (Final Values)|-1.0098|STANDARD_DEVIATION|0.005|<|0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000249245 baseline and post exposure||||<0.001
74044970|NCT02917629|147641890|SUPERIORITY||Mean Difference (Final Values)|1.0007|STANDARD_DEVIATION|0.0063|<|0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000261792 baseline and post exposure||||<0.001
74044971|NCT02917629|147641891|SUPERIORITY||Mean Difference (Final Values)|1.006|STANDARD_DEVIATION|0.006||0.002|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000234806 baseline and post exposure||||0.002
74044972|NCT02917629|147641892|SUPERIORITY||Mean Difference (Final Values)|1.0013|STANDARD_DEVIATION|0.0072||0.002|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000232479 baseline and post exposure||||0.002
74044973|NCT02917629|147641892|SUPERIORITY||Mean Difference (Final Values)|1.0037|STANDARD_DEVIATION|0.0193||0.02|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000233163 baseline and post exposure||||0.020
74044974|NCT02917629|147641892|SUPERIORITY||Mean Difference (Final Values)|-1.0098|STANDARD_DEVIATION|0.005||0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000249245 baseline and post-exposure||||0.001
74044975|NCT03136484|147641898|NON_INFERIORITY|The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3 rather than zero as in a superiority test.|Treatment difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an analysis of covariance (ANCOVA) with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.||-0.33|-0.65|<.0001
74044976|NCT03136484|147641898|SUPERIORITY||Treatment difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an ANCOVA with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.||-0.33|-0.65|<.0001
74015686|NCT02264990|147582530|OTHER||Odds Ratio (OR)|0.66||||0.455|TWO_SIDED|95.0|0.23|1.9|||Regression, Logistic|Logistic regression adjusted for the covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.|Odds ratio is from covariate adjusted logistic regression with the covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.90|0.23|0.455
74015687|NCT02264990|147582531|OTHER||Hazard Ratio (HR)|0.986||||0.846|TWO_SIDED|95.0|0.827|1.176|||Log Rank|Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.176|0.827|0.846
74044977|NCT00360685|147641959|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Sample size was based on the difference in the proportion of patients in each arm who were predicted to develop severe mucositis defined as clinical grade 3 or 4 per the CTCAE. A sample-size of 42 evaluable subjects per study-arm allowed detection of an absolute difference of 30%, which corresponds to a reduction in the incidence of severe mucositis from 60% in the methotrexate arm to 30% in the MMF arm (alpha=0.05, power=0.80).||||0.06
74044978|NCT00360685|147641960|SUPERIORITY_OR_OTHER|||||||0.8|||||||K-sample tests for comparing the cumulat|||||||0.8
74044979|NCT00360685|147641961|SUPERIORITY_OR_OTHER|||||||0.58|||||||Log Rank|||||||0.58
74044980|NCT01628042|147641989|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.83|||||TWO_SIDED|90.0|1.36|2.46|||ANCOVA|||||2.46|1.36|
74044981|NCT01628042|147641989|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|2.06|||||TWO_SIDED|90.0|1.55|2.74|||ANCOVA|||||2.74|1.55|
74044982|NCT01628042|147641989|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.49|||||TWO_SIDED|90.0|1.11|2.0|||ANCOVA|||||2.00|1.11|
74044983|NCT01628042|147641990|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.42|||||TWO_SIDED|90.0|0.89|2.27|||ANCOVA|||||2.27|0.89|
74044984|NCT01628042|147641990|SUPERIORITY_OR_OTHER||Geometric least-squares mean ration|1.68|||||TWO_SIDED|90.0|1.07|2.63|||ANCOVA|||||2.63|1.07|
74044985|NCT01628042|147641990|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.96|||||TWO_SIDED|90.0|1.23|3.13|||ANCOVA|||||3.13|1.23|
74044986|NCT01628042|147641991|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.55|||||TWO_SIDED|90.0|0.41|0.74|||ANCOVA|||||0.74|0.41|
74044987|NCT01628042|147641991|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.49|||||TWO_SIDED|90.0|0.36|0.65|||ANCOVA|||||0.65|0.36|
74044988|NCT01628042|147641991|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.67|||||TWO_SIDED|90.0|0.5|0.9|||ANCOVA|||||0.90|0.50|
74044989|NCT01696396|147642008|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg group. The primary and key secondary endpoints were tested under a sequential framework of statistical hypotheses, each with 2-sided significance level of 0.10 for the treatment effect of abrilumab 70 mg compared with placebo.|Odds Ratio (OR)|1.15||||0.76|TWO_SIDED|90.0|0.54|2.44|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.44|0.54|0.76
74044990|NCT01696396|147642008|SUPERIORITY||Difference in Adjusted Remission Rates|1.6|||||TWO_SIDED|90.0|-7.9|8.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.9|-7.9|
73880276|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.46||||0.0577|TWO_SIDED|95.0|0.97|6.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.22|0.97|0.0577
73880277|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0706|TWO_SIDED|95.0|0.93|5.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.85|0.93|0.0706
74044991|NCT01696396|147642008|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.91||||0.22|TWO_SIDED|90.0|0.8|4.57|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.57|0.80|0.22
74044992|NCT01696396|147642008|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|9.1|||||TWO_SIDED|90.0|-4.6|19.4||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||19.4|-4.6|
74044993|NCT01696396|147642008|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.05||||0.25|TWO_SIDED|90.0|0.74|5.73|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.73|0.74|0.25
74044994|NCT01696396|147642008|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|10.3|||||TWO_SIDED|90.0|-6.8|22.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.6|-6.8|
74095459|NCT03056157|147740617|SUPERIORITY||Slope|0.18||||0.03|TWO_SIDED|95.0|0.02|0.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = 2.21, d = 0.42.||0.34|0.02|0.03
74095460|NCT03056157|147740617|SUPERIORITY||Slope|-0.17||||0.03|TWO_SIDED|95.0|-0.32|-0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -2.22, d = 0.42.||-0.02|-0.32|0.03
73880278|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0404|TWO_SIDED|95.0|1.04|7.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.00|1.04|0.0404
73880279|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0054|TWO_SIDED|95.0|1.54|11.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.99|1.54|0.0054
74044995|NCT01696396|147642009|SUPERIORITY||Odds Ratio (OR)|1.78||||0.16|TWO_SIDED|90.0|0.9|3.53|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.53|0.90|0.16
74044996|NCT01696396|147642009|SUPERIORITY||Difference in Adjusted Remission Rates|10.9|||||TWO_SIDED|90.0|-1.8|21.0||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||21.0|-1.8|
74044997|NCT01696396|147642009|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.12||||0.13|TWO_SIDED|90.0|0.93|4.84|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.84|0.93|0.13
74044998|NCT01696396|147642009|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|14.7|||||TWO_SIDED|90.0|-2.1|27.5||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||27.5|-2.1|
74044999|NCT01696396|147642009|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|3.1||||0.056|TWO_SIDED|90.0|1.17|8.2|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.20|1.17|0.056
74045000|NCT01696396|147642009|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|23.7|||||TWO_SIDED|90.0|2.8|39.2||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||39.2|2.8|
74045001|NCT01696396|147642010|SUPERIORITY||Odds Ratio (OR)|2.25||||0.021|TWO_SIDED|90.0|1.27|4.01|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.01|1.27|0.021
74045002|NCT01696396|147642010|SUPERIORITY||Difference in Adjusted Response Rates|19.8|||||TWO_SIDED|90.0|5.8|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.3|5.8|
74045003|NCT01696396|147642010|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.9||||0.14|TWO_SIDED|90.0|0.94|3.87|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.87|0.94|0.14
74045004|NCT01696396|147642010|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.7|||||TWO_SIDED|90.0|-2.3|29.7||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||29.7|-2.3|
74045005|NCT01696396|147642010|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.87||||0.23|TWO_SIDED|90.0|0.79|4.39|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.39|0.79|0.23
74045006|NCT01696396|147642010|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.1|||||TWO_SIDED|90.0|-6.4|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.3|-6.4|
74095461|NCT03056157|147740618|SUPERIORITY||Slope|0.32||||0.01|TWO_SIDED|95.0|0.06|0.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(314) = 2.46, d = 0.28.||0.57|0.06|0.01
74095462|NCT03056157|147740618|SUPERIORITY||Slope|0.001||||0.95|TWO_SIDED|95.0|-0.17|0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = 0.06, d = 0.01.||0.18|-0.17|0.95
74095463|NCT03056157|147740618|SUPERIORITY||Slope|-0.31||||0.01|TWO_SIDED|95.0|-0.5|-0.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = -3.32, d = 0.62.||-0.13|-0.50|0.01
74045007|NCT01696396|147642011|SUPERIORITY||Odds Ratio (OR)|1.98||||0.047|TWO_SIDED|90.0|1.13|3.47|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.47|1.13|0.047
74045008|NCT01696396|147642011|SUPERIORITY||Difference in Adjusted Response Rates|16.0|||||TWO_SIDED|90.0|2.4|27.1||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||27.1|2.4|
74045009|NCT01696396|147642011|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|90.0|0.52|2.29|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.29|0.52|0.84
74045010|NCT01696396|147642011|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|1.9|||||TWO_SIDED|90.0|-15.2|15.2||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||15.2|-15.2|
74045011|NCT01696396|147642011|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.15||||0.78|TWO_SIDED|90.0|0.49|2.72|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.72|0.49|0.78
74045012|NCT01696396|147642011|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|3.1|||||TWO_SIDED|90.0|-17.4|18.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||18.3|-17.4|
74045013|NCT01696396|147642012|SUPERIORITY||Odds Ratio (OR)|1.65||||0.34|TWO_SIDED|90.0|0.69|3.91|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.91|0.69|0.34
74045014|NCT01696396|147642012|SUPERIORITY||Difference in Adjusted Remission Rates|5.0|||||TWO_SIDED|90.0|-3.9|11.7||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||11.7|-3.9|
74045015|NCT01696396|147642012|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.82||||0.078|TWO_SIDED|90.0|1.07|7.41|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||7.41|1.07|0.078
74045016|NCT01696396|147642012|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|12.8|||||TWO_SIDED|90.0|-0.6|22.6||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.6|-0.6|
74045017|NCT01696396|147642012|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|3.37||||0.083|TWO_SIDED|90.0|1.07|10.66|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||10.66|1.07|0.083
74095464|NCT03056157|147740618|SUPERIORITY||Slope|-0.21||||0.04|TWO_SIDED|95.0|-0.41|-0.01|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(314) = -2.02, d = 0.23.||-0.01|-0.41|0.04
74095465|NCT03056157|147740618|SUPERIORITY||Slope|-0.16||||0.03|TWO_SIDED|95.0|-0.3|-0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(113) = -2.18, d = 0.03.||-0.02|-0.30|0.03
74095466|NCT03056157|147740618|SUPERIORITY||Slope|0.05||||0.48|TWO_SIDED|95.0|-0.09|0.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = 0.70, d = 0.13.||0.20|-0.09|0.48
73880280|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0186|TWO_SIDED|95.0|1.22|9.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.27|1.22|0.0186
74095467|NCT03056157|147740619|SUPERIORITY||Slope|0.7||||0.45|TWO_SIDED|95.0|-1.12|2.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = 0.76, d = 0.09.||2.52|-1.12|0.45
74095468|NCT03056157|147740619|SUPERIORITY||Slope|-1.2||||0.08|TWO_SIDED|95.0|-2.52|0.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(113) = -1.79, d = 0.34.||0.12|-2.52|0.08
74095469|NCT03056157|147740619|SUPERIORITY||Slope|-1.91||||0.003|TWO_SIDED|95.0|-3.15|-0.66|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(113) = -3.00, d = 0.56.||-0.66|-3.15|0.003
74015688|NCT02264990|147582532|OTHER||Hazard Ratio (HR)|1.035||||0.473|TWO_SIDED|95.0|0.867|1.235|||Log Rank|Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.235|0.867|0.473
74015689|NCT02264990|147582533|OTHER||Odds Ratio (OR)|0.86||||0.409|TWO_SIDED|95.0|0.59|1.24|||Regression, Logistic|Logistic regression adjusted for the covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|Odds ratio is from covariate adjusted logistic regression with the covariates being LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.24|0.59|0.409
74015690|NCT01849172|147582547|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
74095470|NCT03056157|147740619|SUPERIORITY||standardized effect size of the slope|-0.29||||0.7|TWO_SIDED|95.0|-1.75|1.17|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -0.39, d = 0.04.||1.17|-1.75|0.70
74095471|NCT03056157|147740619|SUPERIORITY||Slope|-0.59||||0.27|TWO_SIDED|95.0|-1.64|0.46|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -1.11, d = 0.12.||0.46|-1.64|0.27
74095472|NCT03056157|147740619|SUPERIORITY||Slope|-0.29||||0.57|TWO_SIDED|95.0|-1.32|0.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -0.57, d = 0.06.||0.72|-1.32|0.57
74095473|NCT03056157|147740620|SUPERIORITY||Slope|3.41||||0.02|TWO_SIDED|95.0|0.56|6.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = 2.35, d = 0.26.||6.25|0.56|0.02
74095474|NCT03056157|147740620|SUPERIORITY||Slope|6.84|||<|0.001|TWO_SIDED|95.0|4.78|8.9|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(116) = -6.53, d = 1.21.||8.90|4.78|<0.001
74095475|NCT03056157|147740620|SUPERIORITY||Slope|3.43||||0.001|TWO_SIDED|95.0|1.47|5.4|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(116) = 3.44, d = 0.64.||5.40|1.47|0.001
74015691|NCT02112370|147582582|SUPERIORITY_OR_OTHER|||||||0.008||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Swallowing difficulty||||0.008
74015692|NCT02112370|147582582|SUPERIORITY_OR_OTHER|||||||0.016||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Anterior neck pain||||0.016
74095476|NCT03056157|147740620|SUPERIORITY||Slope|0.76||||0.51|TWO_SIDED|95.0|-1.5|3.03|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = 0.66, d = 0.07.||3.03|-1.50|0.51
74095477|NCT03056157|147740620|SUPERIORITY||Slope|-0.27||||0.75|TWO_SIDED|95.0|-1.89|1.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = -0.32, d = 0.04.||1.35|-1.89|0.75
74095478|NCT03056157|147740620|SUPERIORITY||Slope|-1.03||||0.2|TWO_SIDED|95.0|-2.61|0.55|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = -1.28, d = 0.14.||0.55|-2.61|0.20
74095479|NCT03056157|147740621|SUPERIORITY||Slope|0.26||||0.004|TWO_SIDED|95.0|0.08|0.43|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 2.93, d = 0.33.||0.43|0.08|0.004
74095480|NCT03056157|147740621|SUPERIORITY||Slope|0.35|||<|0.001|TWO_SIDED|95.0|0.23|0.48|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 5.56, d = 1.04.||0.48|0.23|<0.001
74095481|NCT03056157|147740621|SUPERIORITY||Slope|0.1||||0.11|TWO_SIDED|95.0|-0.02|0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 1.61, d = 0.30.||0.22|-0.02|0.11
74015693|NCT02112370|147582582|SUPERIORITY_OR_OTHER|||||||0.019||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Right chest pain||||0.019
74015694|NCT02112370|147582582|SUPERIORITY_OR_OTHER|||||||0.035||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Left chest pain||||0.035
74015695|NCT02112370|147582582|SUPERIORITY_OR_OTHER|||||||0.089||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Back pain||||0.089
74015696|NCT02112370|147582582|SUPERIORITY_OR_OTHER|||||||0.634||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Posterior neck pain||||0.634
74015697|NCT01142726|147582595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01|STANDARD_ERROR_OF_MEAN|0.55||0.01|TWO_SIDED|95.0|1.18|3.43|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Month 12|Power estimate assumed 2-sided alpha level of 5% and that 60% of abatacept (ABA)+methotrexate (MX) patients (pts) would be in DAS28-CRP remission at Month 12 compared with 38% of MX monotherapy pts. Also assumed that 48% of ABA monotherapy pts would be in DAS28-CRP remission at Month 12, yielding an expected treatment difference from MX of 10% in favor of ABA monotherapy; 116 pts randomized to ABA monotherapy would yield a half-length of the 95% CI around that 10% treatment difference of 13.5%.||3.43|1.18|0.010
74095482|NCT03056157|147740621|SUPERIORITY||Slope|0.007||||0.92|TWO_SIDED|95.0|-0.13|0.15|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.10, d = 0.10.||0.15|-0.13|0.92
74095483|NCT03056157|147740621|SUPERIORITY||Slope|0.02||||0.75|TWO_SIDED|95.0|-0.08|0.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.31, d = 0.03.||0.12|-0.08|0.75
74095484|NCT03056157|147740621|SUPERIORITY||Slope|0.01||||0.86|TWO_SIDED|95.0|-0.09|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.18, d = 0.02.||0.11|-0.09|0.86
74095485|NCT03056157|147740622|SUPERIORITY||Slope|-2.56||||0.15|TWO_SIDED|95.0|-6.1|0.97|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -1.43, d = 0.16.||0.97|-6.10|0.15
74095486|NCT03056157|147740622|SUPERIORITY||Slope|-5.28|||<|0.001|TWO_SIDED|95.0|-7.83|-2.73|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(116) = -4.07, d = 0.76||-2.73|-7.83|<0.001
74095487|NCT03056157|147740622|SUPERIORITY||Slope|-2.71||||0.03|TWO_SIDED|95.0|-5.16|-0.28|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(116) = -2.19, d = 0.41.||-0.28|-5.16|0.03
74095488|NCT03056157|147740622|SUPERIORITY||Slope|-1.38||||0.33|TWO_SIDED|95.0|-4.17|1.42|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -0.97, d = 0.11.||1.42|-4.17|0.33
74095489|NCT03056157|147740622|SUPERIORITY||Slope|-1.54||||0.13|TWO_SIDED|95.0|-3.54|0.46|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -1.51, d = 0.17.||0.46|-3.54|0.13
74015698|NCT01142726|147582595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|STANDARD_ERROR_OF_MEAN|1.15||0.045|TWO_SIDED|95.0|1.02|6.18|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Months 12 and 18|Conditional on statistical significance of the 1st coprimary efficacy analysis (CEA), a sample of 116 patients per arm would provide 98% power for the 2nd CEA comparison of the percentage of patients in DAS28-CRP remission at Months 12 and 18 between the abatacept (ABA)+methotrexate (MTX) arm and the MTX monotherapy arm for intent-to treat population. This sample size calculation assumed 30% remission in the ABA+MTX arm and 8% in the monotherapy arm at Month 18 and a 2-sided alpha level of 5%.||6.18|1.02|0.045
74015699|NCT01142726|147582596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|0.55|1.57|||||At Month 12|||1.57|0.55|
74015700|NCT01142726|147582596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|0.81|5.14|||||At Months 12 and 18|||5.14|0.81|
74015701|NCT00419380|147582615|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Chi-squared|||Two by two contingency table was used to compare our outcome, tube patency yes/no, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.||||.36
74015702|NCT00419380|147582616|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|||||Two by two contingency table was used to compare our outcome, presence/absence of ear drainage, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.|Chi-squared|||||||.26
74015703|NCT01180660|147582620|SUPERIORITY_OR_OTHER||Median Difference (Net)|19.0||||0.01|TWO_SIDED|95.0|3.0|27.0|||Regression, Linear|||A sample size of 22 subjects per group was estimated to achieve 90% power to detect a 16 point difference in the aggregated Qor-40 score for the two study groups to be compared assuming an overall standard deviation of 16 points similar to what was observed in a previous investigation.||27|3|.01
74015704|NCT03861559|147582622|OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
74015705|NCT03861559|147582623|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74015706|NCT03861559|147582625|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74015707|NCT03861559|147582626|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
73880281|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|6.58||||0.0023|TWO_SIDED|95.0|1.96|22.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||22.14|1.96|0.0023
74015708|NCT03861559|147582627|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74015709|NCT03861559|147582629|OTHER|||||||0.14|||||||ANOVA|||||||0.14
74015710|NCT03861559|147582630|OTHER|||||||0.02|||||||ANOVA|||||||0.02
74015711|NCT03861559|147582631|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74015712|NCT03861559|147582633|OTHER|||||||0.15|||||||ANOVA|||||||0.15
74015713|NCT03861559|147582634|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74045018|NCT01696396|147642012|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|16.0|||||TWO_SIDED|90.0|-1.2|28.3||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||28.3|-1.2|
74045019|NCT01696396|147642013|SUPERIORITY||Odds Ratio (OR)|1.52||||0.47|TWO_SIDED|90.0|0.59|3.93|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.93|0.59|0.47
74045020|NCT01696396|147642013|SUPERIORITY||Difference in Adjusted Remission Rates|2.8|||||TWO_SIDED|90.0|-4.7|8.1||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.1|-4.7|
74095490|NCT03056157|147740622|SUPERIORITY||Slope|-0.17||||0.87|TWO_SIDED|95.0|-2.12|1.79|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -0.17, d = 0.02.||1.79|-2.12|0.87
74095491|NCT03056157|147740623|SUPERIORITY||Slope|-0.37||||0.04|TWO_SIDED|95.0|-0.72|-0.01|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -2.03, d = 0.23.||-0.01|-0.72|0.04
74015714|NCT03861559|147582635|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74015715|NCT03861559|147582637|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74015716|NCT03861559|147582638|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74015717|NCT03861559|147582639|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74015718|NCT03861559|147582640|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74015719|NCT03861559|147582641|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74015720|NCT03861559|147582642|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74015721|NCT01110200|147582686|SUPERIORITY_OR_OTHER||Treatment comparison ratio|0.917||||0.71|TWO_SIDED|95.0|0.581|1.447|||Negative bionomial regression model||Annualized rate estimates, the treatment comparison ratio, the confidence interval, and the p-value are from a negative binomial regression model with terms for treatment, country, randomization stratum, baseline severity, and time on treatment.|||1.447|0.581|0.710
74015722|NCT01437397|147582689|SUPERIORITY_OR_OTHER||Least squares mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.073|0.144|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.144|0.073|<0.0001
74015723|NCT01437397|147582689|SUPERIORITY_OR_OTHER||Least squares mean difference|0.087|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.052|0.123|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.123|0.052|<0.0001
74015724|NCT01437397|147582690|SUPERIORITY_OR_OTHER||Least squares mean difference|0.045|STANDARD_ERROR_OF_MEAN|0.017||0.01|TWO_SIDED|95.0|0.011|0.079|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.079|0.011|0.010
74095492|NCT03056157|147740623|SUPERIORITY||Slope|-0.83|||<|0.001|TWO_SIDED|95.0|-1.09|-0.58|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(116)= -6.40, d = 1.19.||-0.58|-1.09|<0.001
74015725|NCT01437397|147582690|SUPERIORITY_OR_OTHER||Least squares mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.017||0.133|TWO_SIDED|95.0|-0.008|0.06|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.060|-0.008|0.133
74015726|NCT01437397|147582691|SUPERIORITY_OR_OTHER||Least squares mean difference|1.436|STANDARD_ERROR_OF_MEAN|0.297|<|0.0001|TWO_SIDED|95.0|0.854|2.018|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||2.018|0.854|<0.0001
74015727|NCT01437397|147582691|SUPERIORITY_OR_OTHER||Least squares mean difference|1.395|STANDARD_ERROR_OF_MEAN|0.294|<|0.0001|TWO_SIDED|95.0|0.818|1.972|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||1.972|0.818|<0.0001
74015728|NCT01437397|147582692|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.353|STANDARD_ERROR_OF_MEAN|1.075|<|0.0001|TWO_SIDED|95.0|-6.462|-2.244|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||-2.244|-6.462|<0.0001
74015729|NCT01437397|147582692|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.728|STANDARD_ERROR_OF_MEAN|1.066||0.0005|TWO_SIDED|95.0|-5.819|-1.637|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||-1.637|-5.819|0.0005
74015730|NCT00903175|147582693|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective was to assess the non-inferiority of everolimus as compared to Sunitinib in terms of PFS-1L \& was based on Bayesian methodology. If the estimated HR for PFS-1L had a value ≤ 1.1, non-inferiority of everolimus to Sunitinib would be declared. Non-inferiority of everolimus compared with Sunitinib as a first-line therapy was not achieved. The estimated HR for PFS-1L was 1.43 which did not satisfy the protocol-defined non-inferiority margin of a HR ≤ 1.1.|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|1.15|1.77||||||||1.77|1.15|
74015731|NCT01687712|147582706|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (\& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|3.7|||||TWO_SIDED|95.0|-1.3|8.7|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2- p1 \> ∆ and H1: p2- p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."||8.7|-1.3|
74015732|NCT01687712|147582707|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (\& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-2.5|8.1|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2- p1 \> ∆ and H1: p2- p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."||8.1|-2.5|
74015733|NCT01687712|147582711|SUPERIORITY|Comparisons were tested against a null of zero at the two-side 5% significance level.||||||0.612||||||P-values are based upon Type III sums of squares.|ANCOVA|Treatment group and Site are included as factors.||"The null and alternative hypotheses are as follows:~H0: p2- p1 = 0 and H1: p2- p1 ≠0,~where p1 is the least squares adjusted mean number of oocytes retrieved in the AFOLIA treatment group and p2 is the least squares adjusted mean number of oocytes retrieved in the Gonal f® treatment group."||||0.612
74015734|NCT04817111|147582738|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
74015735|NCT04817111|147582740|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
74015736|NCT04817111|147582741|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
74015737|NCT01318109|147582772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.751|||||TWO_SIDED|95.0|-0.923|-0.579||||||||-0.579|-0.923|
74015738|NCT01318109|147582772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.858|||||TWO_SIDED|95.0|-1.019|-0.697||||||||-0.697|-1.019|
74015739|NCT01318109|147582773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.191|||||TWO_SIDED|95.0|-0.247|-0.135||||||||-0.135|-0.247|
74015740|NCT01318109|147582773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.192|||||TWO_SIDED|95.0|-0.242|-0.143||||||||-0.143|-0.242|
74015741|NCT01318109|147582774|SUPERIORITY_OR_OTHER||Hazard Ratio, log|-0.386|||||TWO_SIDED|95.0|-0.469|-0.303||||||||-0.303|-0.469|
74015742|NCT01318109|147582774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.403|||||TWO_SIDED|95.0|-0.484|-0.323||||||||-0.323|-0.484|
74045021|NCT01696396|147642013|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.32||||0.21|TWO_SIDED|90.0|0.77|6.98|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.98|0.77|0.21
74045022|NCT01696396|147642013|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|6.8|||||TWO_SIDED|90.0|-4.3|14.5||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.5|-4.3|
74015743|NCT01318109|147582775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.621|||||TWO_SIDED|95.0|-0.757|-0.486||||||||-0.486|-0.757|
74015744|NCT01318109|147582775|SUPERIORITY_OR_OTHER||Hazard Ratio, log|-0.692|||||TWO_SIDED|95.0|-0.814|-0.569||||||||-0.569|-0.814|
73880282|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.63||||0.0118|TWO_SIDED|95.0|1.33|9.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.93|1.33|0.0118
74045023|NCT01696396|147642013|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.66||||0.21|TWO_SIDED|90.0|0.75|9.45|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||9.45|0.75|0.21
73880283|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|5.57||||0.002|TWO_SIDED|95.0|1.88|16.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.53|1.88|0.0020
74015745|NCT01318109|147582776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.26|||||TWO_SIDED|95.0|-26.12|-12.4||||||||-12.40|-26.12|
74015746|NCT01318109|147582776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.27|||||TWO_SIDED|95.0|-30.43|-16.12||||||||-16.12|-30.43|
74015747|NCT01318109|147582777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||||TWO_SIDED|95.0|-24.54|-10.66||||||||-10.66|-24.54|
74015748|NCT01318109|147582777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.35|||||TWO_SIDED|95.0|-28.32|-14.39||||||||-14.39|-28.32|
74015749|NCT01318109|147582778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.87|||||TWO_SIDED|95.0|-25.95|-11.79||||||||-11.79|-25.95|
74015750|NCT01318109|147582778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||||TWO_SIDED|95.0|-25.43|-10.9||||||||-10.90|-25.43|
74015751|NCT01318109|147582779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.24|||||TWO_SIDED|95.0|-26.32|-10.16||||||||-10.16|-26.32|
74015752|NCT01318109|147582779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.38|||||TWO_SIDED|95.0|-30.87|-13.88||||||||-13.88|-30.87|
74015753|NCT01318109|147582780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.89|||||TWO_SIDED|95.0|-20.14|2.37||||||||2.37|-20.14|
74015754|NCT01318109|147582780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.41|||||TWO_SIDED|95.0|-16.34|3.52||||||||3.52|-16.34|
74015755|NCT01328951|147582782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8183|TWO_SIDED|95.0|0.85|1.22|||Log Rank||The HR and 95% confidence interval (CI) were estimated by Cox regression.|Unstratified Analysis.||1.22|0.85|0.8183
74015756|NCT01328951|147582782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.5256|TWO_SIDED|95.0|0.87|1.32|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.||1.32|0.87|0.5256
74015757|NCT01328951|147582783|SUPERIORITY_OR_OTHER||Difference in Event-Free Rate|-0.4||||0.9207|TWO_SIDED|95.0|-8.25|7.45|||Chi-squared|||||7.45|-8.25|0.9207
74015758|NCT01328951|147582785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4759|TWO_SIDED|95.0|0.8|1.11|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Unstratified Analysis.||1.11|0.80|0.4759
74015759|NCT01328951|147582785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1635|TWO_SIDED|95.0|0.72|1.06|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.||1.06|0.72|0.1635
74015760|NCT01328951|147582786|SUPERIORITY_OR_OTHER||Difference in Event-Free Rate|-2.89||||0.4069|TWO_SIDED|95.0|-9.7|3.93|||Chi-squared|||||3.93|-9.70|0.4069
74015761|NCT01328951|147582787|SUPERIORITY_OR_OTHER||Difference in Response Rate|2.78||||0.1097|TWO_SIDED|95.0|-0.78|6.35|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.|||6.35|-0.78|0.1097
74015762|NCT01328951|147582787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.87|3.72|||||The 95% CI for OR was constructed using the Wald method.|||3.72|0.87|
74015763|NCT01328951|147582789|SUPERIORITY_OR_OTHER||Difference in Response Rate|1.99||||0.6062|TWO_SIDED|95.0|-5.74|9.72|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.|||9.72|-5.74|0.6062
74015764|NCT01328951|147582789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.79|1.49|||||The 95% CI for OR was constructed using the Wald method.|||1.49|0.79|
74015765|NCT00970853|147582790|NON_INFERIORITY_OR_EQUIVALENCE|The original sample for this study (N=302) was sufficient for an 80% detection of differences in means of at least 1/2 standard deviation. This analysis presents the results of the follow-up of the original sample.||||||0.39||||||non-adjusted for multiple comparisons|t-test, 2 sided|||||||0.39
74015766|NCT00970853|147582791|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.99|||||||t-test, 2 sided|||||||.99
74015767|NCT00970853|147582792|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.16|||||||t-test, 2 sided|||||||0.16
74015768|NCT00970853|147582793|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.4|||||||t-test, 2 sided|||||||.40
74015769|NCT00970853|147582794|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.56|||||||t-test, 2 sided|||||||.56
74015770|NCT00970853|147582795|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.34|||||||t-test, 2 sided|||||||.34
74015771|NCT00970853|147582796|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.85|||||||t-test, 2 sided|||||||.85
74015772|NCT00970853|147582797|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.61|||||||t-test, 2 sided|||||||.61
74015773|NCT00970853|147582798|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.67|||||||t-test, 2 sided|||||||.67
74015774|NCT00271817|147582819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.4|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-41.4|-35.4||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-35.4|-41.4|<0.001
74015775|NCT00271817|147582820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.5|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-36.5|-30.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-30.6|-36.5|<0.001
74015776|NCT00271817|147582821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|18.8|25.3||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||25.3|18.8|<0.001
74045024|NCT01696396|147642013|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|8.4|||||TWO_SIDED|90.0|-6.0|17.9||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||17.9|-6.0|
74045025|NCT01696396|147642014|SUPERIORITY||LS Mean Treatment Difference|-42.09||||0.006|TWO_SIDED|90.0|-67.3|-16.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-16.9|-67.3|0.006
74045026|NCT01696396|147642014|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-40.79||||0.095|TWO_SIDED|90.0|-81.5|-0.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-0.5|-81.5|0.095
74045027|NCT01696396|147642014|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-36.84||||0.11|TWO_SIDED|90.0|-74.3|0.7|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||0.7|-74.3|0.11
74045028|NCT01696396|147642015|SUPERIORITY||LS Mean Treatment Difference|-27.47||||0.045|TWO_SIDED|90.0|-50.0|-4.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-4.9|-50.0|0.045
74045029|NCT01696396|147642015|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-23.59||||0.27|TWO_SIDED|90.0|-58.7|11.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||11.5|-58.7|0.27
74095493|NCT03056157|147740623|SUPERIORITY||Slope|-0.47||||0.002|TWO_SIDED|95.0|-0.71|-0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(116) = -3.78, d = 0.70.||-0.22|-0.71|0.002
74095494|NCT03056157|147740623|SUPERIORITY||Slope|-0.08||||0.58|TWO_SIDED|95.0|-0.37|0.21|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.56, d = 0.06.||0.21|-0.37|0.58
74095495|NCT03056157|147740623|SUPERIORITY||Slope|-0.1||||0.34|TWO_SIDED|95.0|-0.31|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.96, d = 0.11.||0.11|-0.31|0.34
74095496|NCT03056157|147740623|SUPERIORITY||Slope|-0.02||||0.85|TWO_SIDED|95.0|-0.22|0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.19, d = 0.02.||0.18|-0.22|0.85
74095497|NCT03056157|147740624|SUPERIORITY|We log-transformed CTS2 scores because they were heavily positively skewed in conjunction with zero-inflation.|Slope|-0.23||||0.07|TWO_SIDED|95.0|-0.48|0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319)= -1.82, d = 0.20.||0.02|-0.48|0.07
74095498|NCT03056157|147740624|SUPERIORITY||Slope|-0.13||||0.17|TWO_SIDED|95.0|-0.31|-0.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(116) = -1.39, d = 0.16.||-0.05|-0.31|0.17
74095499|NCT03056157|147740624|SUPERIORITY||Slope|0.1||||0.24|TWO_SIDED|95.0|-0.07|0.27|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(116) = 1.18, d = 0.13.||0.27|-0.07|0.24
74095500|NCT03056157|147740624|SUPERIORITY||Slope|0.11||||0.71|TWO_SIDED|95.0|-0.23|0.15|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -0.37, d = 0.04.||0.15|-0.23|0.71
74015777|NCT00271817|147582822|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-18.7|||<|0.001||95.0|-22.6|-14.7||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender|"Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic."|||-14.7|-22.6|<0.001
74045030|NCT01696396|147642015|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-16.37||||0.45|TWO_SIDED|90.0|-51.8|19.1|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||19.1|-51.8|0.45
74045031|NCT00394277|147642019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.075||||0.584||95.0|0.831|1.391||All secondary comparisons were tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||This reflects the primary protocol-specified comparison (standard Pegasys induction dosing arms versus pooled Pegasys induction dosing arms). The study was designed to have at least 86% power for testing the null hypothesis of no difference between these two pooled groups, with assumed response rates of 28%, 32%, 36%, and 43% in the four treatment arms.||1.391|0.831|0.584
74045032|NCT00394277|147642020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.039||||0.775||95.0|0.803|1.344||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.344|0.803|0.775
74045033|NCT00394277|147642021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.004||||0.973||95.0|0.777|1.299||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.299|0.777|0.973
74045034|NCT00394277|147642022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.008||||0.951||95.0|0.78|1.304||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.304|0.780|0.951
74095501|NCT03056157|147740624|SUPERIORITY||Slope|-0.07||||0.32|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -1.00, d = 0.11.||0.07|-0.21|0.32
74095502|NCT03056157|147740624|SUPERIORITY||Slope|-0.04||||0.61|TWO_SIDED|95.0|-0.17|0.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -0.51, d = 0.06.||0.10|-0.17|0.61
74015778|NCT00271817|147582823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|18.0|25.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||25.0|18.0|<0.001
74015779|NCT00271817|147582824|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.6|||<|0.001||95.0|-21.8|-13.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender.|"Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic."|||-13.6|-21.8|<0.001
74015780|NCT00271817|147582825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-10.4|-4.2||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-4.2|-10.4|<0.001
74045035|NCT02712008|147642024|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|-2.09||||0.1368|TWO_SIDED|95.0||0.67||Threshold for significance at 0.05 level.|ANCOVA|||||0.67|- 4.84|0.1368
74045036|NCT02712008|147642024|SUPERIORITY||Least square mean difference|0.04||||0.9716|TWO_SIDED|95.0||2.18||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||2.18|- 2.10|0.9716
74045037|NCT02712008|147642025|SUPERIORITY||Least square mean difference|2.15||||0.1665|TWO_SIDED|95.0|-0.9|5.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.20|-0.90|0.1665
74045038|NCT02712008|147642025|SUPERIORITY||Least square mean difference|1.9||||0.2223|TWO_SIDED|95.0|-1.16|4.95||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||4.95|-1.16|0.2223
74095503|NCT03056157|147740625|SUPERIORITY||Slope|-0.07||||0.74|TWO_SIDED|95.0|-0.5|0.36|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(318) = -0.33, d = 0.04||0.36|-0.50|0.74
74095504|NCT03056157|147740625|SUPERIORITY||Slope|-0.12||||0.44|TWO_SIDED|95.0|-0.43|0.19|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.77, d = 0.14.||0.19|-0.43|0.44
74045039|NCT02712008|147642025|SUPERIORITY||Least square mean difference|0.39||||0.7943|TWO_SIDED|95.0|-2.54|3.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||3.32|-2.54|0.7943
74045040|NCT02712008|147642025|SUPERIORITY||Least square mean difference|0.66||||0.6655|TWO_SIDED|95.0|-2.35|3.67||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||3.67|-2.35|0.6655
74045041|NCT02712008|147642025|SUPERIORITY||Least square mean difference|2.33||||0.1278|TWO_SIDED|95.0|-0.67|5.33||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.33|-0.67|0.1278
74045042|NCT02712008|147642025|SUPERIORITY||Least square mean difference|-1.51||||0.3159|TWO_SIDED|-1.51|-4.47|1.45||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||1.45|-4.47|0.3159
74045043|NCT02712008|147642025|SUPERIORITY||Least square mean difference|-0.27||||0.8537|TWO_SIDED|95.0|-3.18|2.63||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.63|-3.18|0.8537
74045044|NCT02712008|147642026|SUPERIORITY||Least square mean difference|-24.43||||0.1105|TWO_SIDED|95.0|-54.46|5.61||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||5.61|-54.46|0.1105
74045045|NCT02712008|147642026|SUPERIORITY||Least square mean difference|-27.79||||0.0183|TWO_SIDED|95.0||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||- 4.74|- 50.83|0.0183
74045046|NCT02712008|147642027|SUPERIORITY||Least square mean difference|-55.91||||0.004|TWO_SIDED|95.0||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||- 18.01|- 93.81|0.0040
74045047|NCT02712008|147642027|SUPERIORITY||Least square mean difference|-40.51||||0.0365|TWO_SIDED|95.0|-78.46|-2.57||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-2.57|-78.46|0.0365
74045048|NCT02712008|147642027|SUPERIORITY||Least square mean difference|-37.15||||0.0454|TWO_SIDED|95.0|-73.53|-0.77||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-0.77|-73.53|0.0454
74045049|NCT02712008|147642027|SUPERIORITY||Least square mean difference|1.75||||0.9266|TWO_SIDED|95.0|-35.54|39.03||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||39.03|-35.54|0.9266
74045050|NCT02712008|147642027|SUPERIORITY||Least square mean difference|-15.49||||0.4116|TWO_SIDED|95.0|-52.58|21.59||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||21.59|-52.58|0.4116
74045051|NCT02712008|147642027|SUPERIORITY||Least square mean difference|3.36||||0.8574|TWO_SIDED|95.0|-33.42|40.14||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||40.14|-33.42|0.8574
74045052|NCT02712008|147642027|SUPERIORITY||Least square mean difference|-38.9||||0.0351|TWO_SIDED|95.0|-75.06|-2.73||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-2.73|-75.06|0.0351
74045053|NCT02712008|147642028|SUPERIORITY||difference in percentages|-1.8||||0.7617|TWO_SIDED|95.0|-13.5|9.8||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.||9.8|-13.5|0.7617
74045054|NCT02712008|147642028|SUPERIORITY||difference in percentages|6.1||||0.2268|TWO_SIDED|95.0||16.3||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.||16.3|- 4.1|0.2268
74045055|NCT02712008|147642029|SUPERIORITY||difference in percentages|-1.3||||0.8896|TWO_SIDED|95.0|-20.4|17.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||17.7|-20.4|0.8896
74045056|NCT02712008|147642029|SUPERIORITY||difference in percentages|6.4||||0.5021|TWO_SIDED|95.0|-12.6|25.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||25.5|-12.6|0.5021
74045057|NCT02712008|147642029|SUPERIORITY||difference in percentages|6.0||||0.5273|TWO_SIDED|95.0|-12.8|24.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||24.7|-12.8|0.5273
74045058|NCT02712008|147642029|SUPERIORITY||difference in percentages|-1.5||||0.8683|TWO_SIDED|95.0|-19.7|16.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||16.6|-19.7|0.8683
74045059|NCT02712008|147642029|SUPERIORITY||difference in percentages|8.8||||0.3546|TWO_SIDED|95.0|-9.8|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||27.4|-9.8|0.3546
74045060|NCT02712008|147642029|SUPERIORITY||difference in percentages|0.2||||0.9801|TWO_SIDED|95.0|-19.0|19.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||19.5|-19.0|0.9801
74045061|NCT02712008|147642029|SUPERIORITY||difference in percentages|8.8||||0.3528|TWO_SIDED|95.0|-9.9|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||27.4|-9.9|0.3528
74045062|NCT01280812|147642030|SUPERIORITY||Median Difference (Net)|1100.0|STANDARD_DEVIATION|3000.0|||TWO_SIDED|95.0|||||Mixed Models Analysis|Two-sided P values less than .05 were considered statistically significant.||Intent to treat analysis||||
74045063|NCT03189563|147642125|SUPERIORITY|||||||0.3656||||||p-value is from ANCOVA model adjusted for baseline motor MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3656
74045064|NCT03189563|147642125|SUPERIORITY|||||||0.3119||||||p-value is from ANCOVA model adjusted for baseline motor MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3119
74045065|NCT03189563|147642126|SUPERIORITY|||||||0.147||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1470
74045066|NCT03189563|147642126|SUPERIORITY|||||||0.252||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2520
74045067|NCT03189563|147642127|SUPERIORITY|||||||0.1528||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 1 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1528
74045068|NCT03189563|147642127|SUPERIORITY|||||||0.6146||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 1 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.6146
74045069|NCT03189563|147642128|SUPERIORITY|||||||0.5691||||||p-value is from ANCOVA model adjusted for baseline S\&E scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.5691
74045070|NCT03189563|147642128|SUPERIORITY|||||||0.1309||||||p-value is from ANCOVA model adjusted for baseline S\&E scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1309
74045071|NCT03189563|147642129|SUPERIORITY|||||||0.7913||||||p-value is from ANCOVA model adjusted for baseline PDQ-39 summary index. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.7913
74045072|NCT03189563|147642129|SUPERIORITY|||||||0.9399||||||p-value is from ANCOVA model adjusted for baseline PDQ-39 summary index. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.9399
74045073|NCT03189563|147642130|SUPERIORITY|||||||0.4978||||||p-value is from ANCOVA model adjusted for baseline H\&Y scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.4978
74045074|NCT03189563|147642130|SUPERIORITY|||||||0.888||||||p-value is from ANCOVA model adjusted for baseline H\&Y scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.8880
74045075|NCT03189563|147642131|SUPERIORITY|||||||0.5755||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 2 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.5755
74045076|NCT03189563|147642131|SUPERIORITY|||||||0.1517||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 2 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1517
74045077|NCT03189563|147642132|SUPERIORITY|||||||0.2095||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 3 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2095
74045078|NCT03189563|147642132|SUPERIORITY|||||||0.6094||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 3 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.6094
74045079|NCT03189563|147642133|SUPERIORITY|||||||0.226||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 4 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2260
74045080|NCT03189563|147642133|SUPERIORITY|||||||0.226||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 4 subscale score All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2260
74045081|NCT03189563|147642134|SUPERIORITY|||||||0.8274||||||p-value is from ANCOVA model adjusted for baseline CGI-S score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.8274
74045082|NCT03189563|147642134|SUPERIORITY|||||||0.3416||||||p-value is from ANCOVA model adjusted for baseline CGI-S score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3416
74045083|NCT03189563|147642135|SUPERIORITY|||||||0.4052||||||P-value is from ANCOVA model. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||||||0.4052
74045084|NCT03189563|147642135|SUPERIORITY|||||||0.2643||||||P-value is from ANCOVA model. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||||||0.2643
74095505|NCT03056157|147740625|SUPERIORITY||Slope|-0.06||||0.74|TWO_SIDED|95.0|-0.35|0.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.34, d = 0.06.||0.24|-0.35|0.74
74095506|NCT03056157|147740625|SUPERIORITY||Slope|-0.1||||0.57|TWO_SIDED|95.0|-0.45|0.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.57, d = 0.11.||0.25|-0.45|0.57
74095507|NCT03056157|147740625|SUPERIORITY||Slope|-0.03||||0.82|TWO_SIDED|95.0|-0.28|0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.23, d = 0.04.||0.22|-0.28|0.82
74095508|NCT03056157|147740625|SUPERIORITY||Slope|0.07||||0.57|TWO_SIDED|95.0|-0.17|0.31|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = 0.58, d = 0.11.||0.31|-0.17|0.57
74095509|NCT03056157|147740626|SUPERIORITY||Slope|-1.1||||0.16|TWO_SIDED|95.0|-2.63|0.43|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(316) = -1.42, d = 0.16.||0.43|-2.63|0.16
74095510|NCT03056157|147740626|SUPERIORITY||Slope|-0.76||||0.18|TWO_SIDED|95.0|-1.87|0.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114)= -1.35, d = 0.25.||0.35|-1.87|0.18
74095511|NCT03056157|147740626|SUPERIORITY||Slope|0.34||||0.53|TWO_SIDED|95.0|-0.71|1.39|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = 0.63, d = 0.12.||1.39|-0.71|0.53
74095512|NCT03056157|147740626|SUPERIORITY||Slope|-0.6||||0.37|TWO_SIDED|95.0|-1.93|0.73|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(316) = -0.89, d = 0.12.||0.73|-1.93|.37
74045085|NCT00937326|147642197|SUPERIORITY|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.25 g/day in number of participants with any AE.||||0.4816
74045086|NCT00937326|147642197|SUPERIORITY|||||||0.1147||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.5 g/day in number of participants with any AE.||||0.1147
74095513|NCT03056157|147740626|SUPERIORITY||Slope|-0.04||||0.94|TWO_SIDED|95.0|-1.0|0.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = -0.08, d = 0.02.||0.92|-1.00|0.94
74095514|NCT03056157|147740626|SUPERIORITY||Slope|0.57||||0.23|TWO_SIDED|95.0|-0.35|1.48|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = 1.21, d = 0.23.||1.48|-0.35|0.23
74095515|NCT03056157|147740627|SUPERIORITY||Slope|3.98||||0.01|TWO_SIDED|95.0|0.83|7.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 2.49, d = 0.28.||7.13|0.83|0.01
74095516|NCT03056157|147740627|SUPERIORITY||Slope|4.84|||<|0.001|TWO_SIDED|95.0|2.55|7.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 4.16, d = 0.78.||7.13|2.55|<0.001
74095517|NCT03056157|147740627|SUPERIORITY||Slope|0.85||||0.44|TWO_SIDED|95.0|-1.31|3.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 0.78, d = 0.15.||3.02|-1.31|0.44
73880284|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.71||||0.043|TWO_SIDED|95.0|1.03|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.14|1.03|0.0430
74045087|NCT00937326|147642197|SUPERIORITY|||||||1||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 1.0 g/day in number of participants with any AE.||||1.0000
74045088|NCT00937326|147642197|SUPERIORITY|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 2.0 g/day in number of participants with any AE.||||0.4816
74095518|NCT03056157|147740627|SUPERIORITY||Slope|0.21||||0.88|TWO_SIDED|95.0|-2.32|2.75|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.17, d = 0.02.||2.75|-2.32|0.88
74095519|NCT03056157|147740627|SUPERIORITY||Slope|0.55||||0.55|TWO_SIDED|95.0|-1.27|2.37|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.60, d = 0.07.||2.37|-1.27|0.55
74095520|NCT03056157|147740627|SUPERIORITY||Slope|0.38||||0.7|TWO_SIDED|95.0|-1.42|2.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.38, d = 0.04.||2.10|-1.42|0.70
74095521|NCT03056157|147740628|SUPERIORITY||Slope|-0.04||||0.8|TWO_SIDED|95.0|-0.32|0.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(318) = -0.25, d = 0.03.||0.25|-0.32|0.80
74095522|NCT03056157|147740628|SUPERIORITY||Slope|0.04||||0.57|TWO_SIDED|95.0|-0.09|0.16|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(115) = 0.57, d = 0.11.||0.16|-0.09|0.57
74095523|NCT03056157|147740628|SUPERIORITY||Slope|-0.01||||0.82|TWO_SIDED|95.0|-0.14|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(115) = -0.23, d = 0.04.||0.11|-0.14|0.82
74095524|NCT03056157|147740628|SUPERIORITY||Slope|0.05||||0.57|TWO_SIDED|95.0|-0.13|0.23|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(320) = 0.57, d = 0.06.||0.23|-0.13|0.57
74045089|NCT00937326|147642221|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|168.4|||||TWO_SIDED|90.0|123.87|228.94|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding confidence interval (CI) were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.25 g/day.||228.94|123.87|
74045090|NCT00937326|147642221|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|110.88|||||TWO_SIDED|90.0|88.18|139.43|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.25 g/day.||139.43|88.18|
74095525|NCT03056157|147740629|SUPERIORITY||Slope|3.91||||0.002|TWO_SIDED|95.0|1.48|6.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 3.16, d = 0.32.||6.35|1.48|0.002
74095526|NCT03056157|147740629|SUPERIORITY||Slope|4.16|||<|0.001|TWO_SIDED|95.0|2.41|5.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(121) = 4.66, d = 0.85.||5.92|2.41|<0.001
74095527|NCT03056157|147740629|SUPERIORITY||Slope|0.25||||0.78|TWO_SIDED|95.0|-1.44|1.94|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(121) = 0.63, d = 0.11.||1.94|-1.44|0.78
74045091|NCT00937326|147642221|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|133.11|||||TWO_SIDED|90.0|100.55|176.21|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.5 g/day.||176.21|100.55|
74045092|NCT00937326|147642221|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Other|94.3|||||TWO_SIDED|90.0|70.31|126.48|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.5 g/day.||126.48|70.31|
74045093|NCT00937326|147642221|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|141.63|||||TWO_SIDED|90.0|111.2|180.39|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 1.0 g/day.||180.39|111.20|
74045094|NCT00937326|147642221|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.46|||||TWO_SIDED|90.0|85.56|153.11|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1for AUC 0-infinity of SRT2104 1.0 g/day.||153.11|85.56|
74045095|NCT00937326|147642221|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|167.09|||||TWO_SIDED|90.0|120.73|231.25|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 2.0 g/day.||231.25|120.73|
74045096|NCT00937326|147642221|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|117.73|||||TWO_SIDED|90.0|85.14|162.79|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 2.0 g/day.||162.79|85.14|
74045097|NCT00937326|147642222|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|122.22|||||TWO_SIDED|90.0|86.94|171.8|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.25 g/day.||171.80|86.94|
74045098|NCT00937326|147642222|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|94.45|||||TWO_SIDED|90.0|69.07|129.16|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.5 g/day.||129.16|69.07|
74045099|NCT00937326|147642222|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.79|||||TWO_SIDED|90.0|91.54|143.95|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 1.0 g/day.||143.95|91.54|
74045100|NCT00937326|147642222|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|120.3|||||TWO_SIDED|90.0|88.66|163.23|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 2.0 g/day.||163.23|88.66|
74045101|NCT00937326|147642227|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPG.||||0.997
74045102|NCT00937326|147642227|SUPERIORITY|||||||0.581||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPG.||||0.581
74045103|NCT00937326|147642227|SUPERIORITY|||||||0.987||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPG.||||0.987
73880285|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.81||||0.2197|TWO_SIDED|95.0|0.7|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.66|0.70|0.2197
74045104|NCT00937326|147642227|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPG.||||0.999
74045105|NCT00937326|147642227|SUPERIORITY|||||||0.85||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPG.||||0.850
74045106|NCT00937326|147642227|SUPERIORITY|||||||0.843||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPG.||||0.843
74045107|NCT00937326|147642227|SUPERIORITY|||||||0.961||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPG.||||0.961
74045108|NCT00937326|147642227|SUPERIORITY|||||||0.939||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPG.||||0.939
74045109|NCT00937326|147642227|SUPERIORITY|||||||0.966||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPG.||||0.966
74045110|NCT00937326|147642227|SUPERIORITY|||||||0.075||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPG.||||0.075
74045111|NCT00937326|147642227|SUPERIORITY|||||||0.7||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPG.||||0.700
74045112|NCT00937326|147642227|SUPERIORITY|||||||0.732||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPG.||||0.732
74045113|NCT00937326|147642227|SUPERIORITY|||||||0.552||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPG.||||0.552
74045114|NCT00937326|147642227|SUPERIORITY|||||||0.196||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPG.||||0.196
74045115|NCT00937326|147642227|SUPERIORITY|||||||0.393||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPG.||||0.393
74045116|NCT00937326|147642227|SUPERIORITY|||||||0.775||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPG.||||0.775
74045117|NCT00937326|147642227|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPG.||||1.000
74095528|NCT03056157|147740629|SUPERIORITY||Slope|-0.05||||0.73|TWO_SIDED|95.0|-0.34|0.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = -0.34, d = 0.01.||0.24|-0.34|0.73
74095529|NCT03056157|147740629|SUPERIORITY||Slope|0.06||||0.58|TWO_SIDED|95.0|-0.15|0.27|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 0.56, d = 0.06.||0.27|-0.15|0.58
74095530|NCT03056157|147740629|SUPERIORITY||Slope|0.11||||0.28|TWO_SIDED|95.0|-0.1|0.31|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 1.07, d = 0.11.||0.31|-0.10|0.28
73888043|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.396|TWO_SIDED|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-1.7|0.3960
74045118|NCT00937326|147642227|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPG.||||0.989
74045119|NCT00937326|147642227|SUPERIORITY|||||||0.603||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPG.||||0.603
74045120|NCT00937326|147642227|SUPERIORITY|||||||0.108||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPG.||||0.108
74045121|NCT00937326|147642228|SUPERIORITY|||||||0.525||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 8.||||0.525
74045122|NCT00937326|147642228|SUPERIORITY|||||||0.818||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 8.||||0.818
74045123|NCT00937326|147642228|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 8.||||0.999
74045124|NCT00937326|147642228|SUPERIORITY|||||||0.809||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 8.||||0.809
74045125|NCT00937326|147642228|SUPERIORITY|||||||0.993||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 15.||||0.993
74045126|NCT00937326|147642228|SUPERIORITY|||||||0.954||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 15.||||0.954
74045127|NCT00937326|147642228|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 15.||||1.000
74045128|NCT00937326|147642228|SUPERIORITY|||||||0.344||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 15.||||0.344
74045129|NCT00937326|147642228|SUPERIORITY|||||||0.968||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 22.||||0.968
74045130|NCT00937326|147642228|SUPERIORITY|||||||0.316||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 22.||||0.316
74045131|NCT00937326|147642228|SUPERIORITY|||||||0.984||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 22.||||0.984
73880286|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1341|TWO_SIDED|95.0|0.8|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.42|0.80|0.1341
73888044|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.6125|TWO_SIDED|95.0|-0.9|1.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-0.9|0.6125
74045132|NCT00937326|147642228|SUPERIORITY|||||||0.235||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 22.||||0.235
74045133|NCT00937326|147642228|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 28.||||1.000
74045134|NCT00937326|147642228|SUPERIORITY|||||||0.656||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 28.||||0.656
74045135|NCT00937326|147642228|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 28.||||0.994
74045136|NCT00937326|147642228|SUPERIORITY|||||||0.285||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 28.||||0.285
74045137|NCT00937326|147642228|SUPERIORITY|||||||0.992||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 35.||||0.992
74045138|NCT00937326|147642228|SUPERIORITY|||||||0.822||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 35.||||0.822
74045139|NCT00937326|147642228|SUPERIORITY|||||||0.538||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 35.||||0.538
74045140|NCT00937326|147642228|SUPERIORITY|||||||0.907||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 35.||||0.907
74045141|NCT00937326|147642229|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPI.||||0.999
74045142|NCT00937326|147642229|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPI.||||0.982
74045143|NCT00937326|147642229|SUPERIORITY|||||||0.677||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPI.||||0.677
74045144|NCT00937326|147642229|SUPERIORITY|||||||0.688||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPI.||||0.688
73888045|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.9059|TWO_SIDED|95.0|-1.1|1.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.3|-1.1|0.9059
74015781|NCT00271817|147582826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.6||0.004||95.0|-8.0|-1.5||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-1.5|-8.0|0.004
74015782|NCT00271817|147582827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-7.7|-2.1||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-2.1|-7.7|<0.001
74015783|NCT00271817|147582828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-10.4|-5.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-5.0|-10.4|<0.001
74015784|NCT00931359|147582829|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Factors of treatment group and analysis center were considered||||||<0.001
74015785|NCT00931359|147582830|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANOVA|||||||0.019
74015786|NCT01295216|147582913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37|||||TWO_SIDED|95.0|-2.15|1.4|||||Systolic blood pressure at 12 months|||1.40|-2.15|
74015787|NCT01295216|147582913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-1.29|1.32|||||Diastolic blood pressure for 12 months|||1.32|-1.29|
74045145|NCT00937326|147642229|SUPERIORITY|||||||0.903||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPI.||||0.903
74045146|NCT00937326|147642229|SUPERIORITY|||||||0.945||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPI.||||0.945
73880287|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0196|TWO_SIDED|95.0|1.23|11.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.05|1.23|0.0196
74015788|NCT01411085|147582919|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.317|TWO_SIDED||||||t-test, 2 sided|||The assessment was between baseline and values for last 8 weeks.||||0.317
74015789|NCT03809611|147582920|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|1.77||0.1832|TWO_SIDED|90.0|-1.34|4.56||One-sided p-value for treatment difference|Mixed Models Analysis|||||4.56|-1.34|0.1832
74015790|NCT03809611|147582921|SUPERIORITY||Odds Ratio (OR)|1.9||||0.283|TWO_SIDED|90.0|0.72|4.78|||Cochran-Mantel-Haenszel|||||4.78|0.72|0.2830
74015791|NCT02193074|147582923|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|50.68|||<|0.0001|TWO_SIDED|95.0|31.81|66.48|||Fisher Exact||exact unconditional confidence interval|||66.48|31.81|< 0.0001
74015792|NCT02193074|147582924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046|||||||Log Rank|Based on log-rank test stratified by disease duration.||||||0.0046
74015793|NCT02193074|147582924|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53||||0.0164|TWO_SIDED|95.0|0.3156|0.8902|||Cox proportional hazards model|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||0.8902|0.3156|0.0164
74015794|NCT02193074|147582925|SUPERIORITY_OR_OTHER_LEGACY||DIfference in percentages|68.53|||<|0.0001|TWO_SIDED|95.0|51.27|81.99|||Fisher Exact|||||81.99|51.27|< 0.0001
74015795|NCT02193074|147582926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041|||||||Log Rank|Based on log-rank test stratified by disease duration (primary analysis).||||||0.0041
74015796|NCT02193074|147582926|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.372||||0.0082|TWO_SIDED|95.0|0.1787|0.7745|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening (sensitivity analysis).||||0.7745|0.1787|0.0082
74015797|NCT02193074|147582928|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|30.21||||0.0004|TWO_SIDED|95.0|10.35|48.09|||Fisher Exact|||||48.09|10.35|0.0004
74015798|NCT02193074|147582929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Log Rank|||||||0.0003
74015799|NCT02193074|147582929|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.24||||0.0014|TWO_SIDED|95.0|0.1002|0.5753|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||0.5753|0.1002|0.0014
74015800|NCT02193074|147582930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3953|||||||Log Rank|||||||0.3953
74015801|NCT02193074|147582930|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.6268|TWO_SIDED|95.0|0.427|1.6698|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||1.6698|0.4270|0.6268
74015802|NCT03124563|147582937|SUPERIORITY||||||=|0.006|||||||Mixed Models Analysis|Controlling for age, gender, and functional health||||||=.006
74015803|NCT03124563|147582938|SUPERIORITY|||||||0.034|||||||Mixed Models Analysis|Controlling for age, gender, and functional health||||||.034
74015804|NCT03124563|147582939|SUPERIORITY|||||||0.065|||||||Mixed Models Analysis|Controlling for age, gender, and education||||||.065
74015805|NCT03124563|147582940|SUPERIORITY|||||||0.308|||||||Mixed Models Analysis|Controlling for age, gender, and level of education||||||.308
74045147|NCT00937326|147642229|SUPERIORITY|||||||0.949||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPI.||||0.949
74045148|NCT00937326|147642229|SUPERIORITY|||||||0.924||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPI.||||0.924
74045149|NCT00937326|147642229|SUPERIORITY|||||||0.394||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPI.||||0.394
74045150|NCT00937326|147642229|SUPERIORITY|||||||0.687||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPI.||||0.687
74045151|NCT00937326|147642229|SUPERIORITY|||||||0.568||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPI.||||0.568
74045152|NCT00937326|147642229|SUPERIORITY|||||||0.486||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPI.||||0.486
74045153|NCT00937326|147642229|SUPERIORITY|||||||0.973||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPI.||||0.973
74045154|NCT00937326|147642229|SUPERIORITY|||||||0.739||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPI.||||0.739
74045155|NCT00937326|147642229|SUPERIORITY|||||||0.731||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPI.||||0.731
74045156|NCT00937326|147642229|SUPERIORITY|||||||0.991||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPI.||||0.991
74045157|NCT00937326|147642229|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPI.||||0.994
74045158|NCT00937326|147642229|SUPERIORITY|||||||0.963||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPI.||||0.963
74045159|NCT00937326|147642229|SUPERIORITY|||||||0.929||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPI.||||0.929
74095531|NCT02605993|147740635|OTHER||||||<|0.0001|TWO_SIDED|95.0||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|Mixed Model for Repeated Measures (MMRM)|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of -40% at Day 253 for Cohorts 1 to 4, with an estimated standard deviation (SD) of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.||||<0.0001
73888046|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.4585|TWO_SIDED|95.0|-2.9|6.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.3|-2.9|0.4585
74095532|NCT02605993|147740635|OTHER||||||<|0.0001|TWO_SIDED|95.0||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of -40% at Day 281 for Cohort 4 only, with an estimated SD of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.||||<0.0001
74095533|NCT02605993|147740636|OTHER|||||||0.0214||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0214
74095534|NCT02605993|147740636|OTHER|||||||0.0313||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.0313
73880288|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.79||||0.0121|TWO_SIDED|95.0|1.41|16.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.26|1.41|0.0121
73880289|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1511|TWO_SIDED|95.0|0.77|5.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.56|0.77|0.1511
74015806|NCT03124563|147582941|SUPERIORITY|||||||0.349|||||||ANOVA|||||||.349
74015807|NCT03124563|147582942|SUPERIORITY|||||||0.022|||||||Mixed Models Analysis|Controlling for age, gender, and level of education||||||.022
74015808|NCT01534533|147582943|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|Chi-squared|||"The null hypothesis was no group difference"||||>0.05
74015809|NCT01534533|147582944|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.992
74015810|NCT01534533|147582945|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.672
74015811|NCT01534533|147582946|SUPERIORITY_OR_OTHER|||||||0.402||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.402
74015812|NCT01534533|147582947|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.636
74015813|NCT03036293|147582951|SUPERIORITY||Mean Difference (Final Values)|1.56||||0.0055|TWO_SIDED|98.33|0.217|2.91|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.91|0.217|0.0055
74015814|NCT03036293|147582951|SUPERIORITY||Mean Difference (Final Values)|2.56|||<|0.0001|TWO_SIDED|98.33|1.1|3.96|||ANCOVA|Baseline score used as covariate. Yeo-Johnson transformation with λ=1,09 was applied. Statistical inference performed for transformed values.|estimate and CL are backtransformed|Mean score differences (begin-end) were compared||3.96|1.1|<0.0001
74015815|NCT03036293|147582951|EQUIVALENCE|equivalence limits were prespecified as \[-2.763; 2.763\]|Mean Difference (Net)|0.89||||0.0008|TWO_SIDED|98.33|-0.64|2.33|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.33|-0.64|0.0008
74015816|NCT03036293|147582952|SUPERIORITY||Mean Difference (Net)|0.6||||0.08|TWO_SIDED|95.0|-0.08|1.54|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.54|-0.08|0.08
74015817|NCT03036293|147582952|SUPERIORITY||Mean Difference (Net)|0.76||||0.044|TWO_SIDED|95.0|0.02|1.66|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.66|0.02|0.044
74015818|NCT03036293|147582953|SUPERIORITY||Mean Difference (Net)|0.69||||0.21|TWO_SIDED|95.0|-0.4|1.78|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.78|-0.4|0.21
74015819|NCT03036293|147582953|SUPERIORITY||Mean Difference (Net)|1.19||||0.027|TWO_SIDED|95.0|0.14|2.26|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.26|0.14|0.027
74015820|NCT03036293|147582954|SUPERIORITY||Odds Ratio (OR)|1.36||||0.065|TWO_SIDED|95.0|0.98|1.89|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.89|0.98|0.065
74015821|NCT03036293|147582954|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0015|TWO_SIDED|95.0|1.22|2.33|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||2.33|1.22|0.0015
74015822|NCT03036293|147582954|SUPERIORITY|||||||0.7|||||||Fisher Exact|||Week 4 frequencies comparison||||0.7
74015823|NCT03036293|147582954|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 8 frequencies comparison||||1
74015824|NCT03036293|147582954|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Week 12 frequencies comparison||||0.01
74015825|NCT03036293|147582954|SUPERIORITY|||||||0.57|||||||Fisher Exact|||Week 4 frequencies comparison||||0.57
74015826|NCT03036293|147582954|SUPERIORITY|||||||0.25|||||||Fisher Exact|||Week 8 frequencies comparison||||0.25
74015827|NCT03036293|147582954|SUPERIORITY|||||||0.001|||||||Fisher Exact|||Week 12 frequencies comparison||||0.001
74015828|NCT03036293|147582955|SUPERIORITY||Odds Ratio (OR)|0.88||||0.46|TWO_SIDED|95.0|0.64|1.23|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.23|0.64|0.46
74015829|NCT03036293|147582955|SUPERIORITY||Odds Ratio (OR)|1.27||||0.17|TWO_SIDED|95.0|0.9|1.79|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.79|0.9|0.17
74015830|NCT03036293|147582955|SUPERIORITY|||||||0.38|||||||Fisher Exact|||Week 4 frequencies comparison||||0.38
74015831|NCT03036293|147582955|SUPERIORITY|||||||0.67|||||||Fisher Exact|||Week 8 frequencies comparison||||0.67
74015832|NCT03036293|147582955|SUPERIORITY|||||||0.85|||||||Fisher Exact|||Week 12 frequencies comparison||||0.85
74015833|NCT03036293|147582955|SUPERIORITY|||||||0.71|||||||Fisher Exact|||Week 4 frequencies comparison||||0.71
74015834|NCT03036293|147582955|SUPERIORITY|||||||0.29|||||||Fisher Exact|||Week 8 frequencies comparison||||0.29
74015835|NCT03036293|147582955|SUPERIORITY|||||||0.007|||||||Fisher Exact|||Week 12 frequencies comparison||||0.007
74045160|NCT00937326|147642229|SUPERIORITY|||||||0.97||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPI.||||0.970
74045161|NCT00937326|147642230|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 8.||||0.989
74045162|NCT00937326|147642230|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 8.||||0.989
74045163|NCT00937326|147642230|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 8.||||0.982
74045164|NCT00937326|147642230|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 8.||||0.999
74045165|NCT00937326|147642230|SUPERIORITY|||||||0.685||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 15.||||0.685
74045166|NCT00937326|147642230|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 15.||||0.999
74095535|NCT02605993|147740637|OTHER|||||||0.0625||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||tatistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0625
74095536|NCT02605993|147740637|OTHER|MMRM||||||0.5||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.||||0.5000
74095537|NCT02605993|147740638|OTHER|||||||0.4871||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.4871
74095538|NCT02605993|147740638|OTHER|||||||0.4688||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.4688
74095539|NCT02605993|147740639|OTHER|||||||0.0023||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0023
74045167|NCT00937326|147642230|SUPERIORITY|||||||0.971||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 15.||||0.971
74045168|NCT00937326|147642230|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 15.||||1.000
74045169|NCT00937326|147642230|SUPERIORITY|||||||0.405||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 22.||||0.405
74045170|NCT00937326|147642230|SUPERIORITY|||||||0.975||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 22.||||0.975
74095540|NCT02605993|147740640|OTHER|||||||0.0029||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0029
74095541|NCT02605993|147740640|OTHER|||||||0.125||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.1250
74095542|NCT02603393|147740642|NON_INFERIORITY|Non-inferiority will be demonstrated if the 95% confidence interval of the treatment difference lies entirely to the right of (higher than) -50 mL.|Mean Difference (Final Values)|-0.026||||0.0404||95.0|-0.053|0.001||1 sided|Mixed Model for Repeated Measures Analys|||||0.001|-0.053|0.0404
74015836|NCT03036293|147582956|SUPERIORITY||Median Difference (Net)|0.00002||||0.314|TWO_SIDED|95.0|-0.00002|0.33|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator for location difference provided|Median changes (begin-end) within groups are compared||0.33|-0.00002|0.314
74015837|NCT03036293|147582956|SUPERIORITY||Median Difference (Net)|0.0||||0.031|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator for location difference provided|Median changes (begin-end) within groups are compared||1|0|0.031
74015838|NCT03036293|147582957|SUPERIORITY||Median Difference (Net)|-0.00001||||0.0021|TWO_SIDED|95.0|-3.0|-0.00001|||Wilcoxon (Mann-Whitney)||Lower is better|||-0.00001|-3|0.0021
74015839|NCT03036293|147582957|SUPERIORITY||Median Difference (Net)|-0.00002||||0.0056|TWO_SIDED|95.0|-1.0|-0.00002|||Wilcoxon (Mann-Whitney)||Lower is better|||-0.00002|-1|0.0056
74015840|NCT02787850|147582980|OTHER||sucess proportion|86.8|||||TWO_SIDED|95.0|71.9|95.6||||||||95.6|71.9|
74015841|NCT02787850|147582980|OTHER||success proportion|76.7|||||TWO_SIDED|95.0|57.7|90.1||||||||90.1|57.7|
74015842|NCT02787850|147582980|OTHER||success proportion|87.7|||||TWO_SIDED|95.0|76.3|94.9||||||||94.9|76.3|
74015843|NCT02787850|147582980|OTHER||success proportion|85.2|||||TWO_SIDED|95.0|66.3|95.8||||||||95.8|66.3|
74015844|NCT02921971|147582983|SUPERIORITY||Least square (LS) Mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.21||0.0291|TWO_SIDED|95.0|-4.71|0.08||Above p-value is one-sided p-value. Threshold for significance is at 0.05 level.|Mixed-effect model with repeated measure|||Analysis was performed using mixed model repeated measures (MMRM) model. The model included fixed categorical effects of treatment group, randomization strata as per IVRS, timepoint, treatment-by-timepoint and strata-by-timepoint interactions, as well as the continuous fixed covariate of baseline and baseline-by-timepoint interactions.||0.08|-4.71|0.0291
74015845|NCT00452699|147582987|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|||<|0.001||95.0|0.07|0.15|||ANCOVA|||||0.15|0.07|<0.001
74015846|NCT00326898|147582991|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.8|TWO_SIDED|97.5|0.85|1.23|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.||||1.23|0.85|0.80
74015847|NCT00326898|147582991|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.72|TWO_SIDED|97.5|0.8|1.17|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.||||1.17|0.80|0.72
74015848|NCT00326898|147582992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|97.5|0.9|1.52|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.|||1.52|0.90|
74015849|NCT00326898|147582992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|97.5|0.75|1.28|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.|||1.28|0.75|
74015850|NCT01166230|147583015|SUPERIORITY_OR_OTHER|||||||0.141|||||||Fisher Exact|||||||0.141
74015851|NCT01166230|147583016|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.041
74015852|NCT01166230|147583017|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|99.0|||||Wilcoxon (Mann-Whitney)|||||||0.056
74015853|NCT02111564|147583021|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.136|TWO_SIDED|95.0|0.52|1.09|||Cox proportional hazards model|||||1.09|0.52|0.136
74015854|NCT02111564|147583022|SUPERIORITY||Hazard Ratio (HR)|1.88||||0.124|TWO_SIDED|95.0|0.84|4.23|||Cox proportional hazards model|||||4.23|0.84|0.124
74015855|NCT02111564|147583023|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.751|TWO_SIDED|95.0|0.62|1.42|||Cox proportional hazards model|||||1.42|0.62|0.751
74015856|NCT02111564|147583024|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.023|TWO_SIDED|95.0|0.22|0.89|||Cox proportional hazards model|||||0.89|0.22|0.023
74015857|NCT02111564|147583025|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.033|TWO_SIDED|95.0|0.54|0.97|||Cox proportional hazards model|||||0.97|0.54|0.033
74015858|NCT02111564|147583026|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.073|TWO_SIDED|95.0|0.6|1.02|||Cox proportional hazards model|||||1.02|0.60|0.073
74015859|NCT02111564|147583027|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.156|TWO_SIDED|95.0|0.58|1.09|||Cox proportional hazards model|||||1.09|0.58|0.156
74015860|NCT04681170|147583042|OTHER||Mean Difference (Net)|-53.91|||<|0.0001|TWO_SIDED|95.0|-61.859|-45.9612|||t-test, 1 sided|||This was a single-arm study, no comparative group can be assigned; the comparison made for the primary efficacy endpoint is done only between baseline and Week 24 in paediatric subjects (5 to ≤17 years of age). Analysis was made using the one-sample t-test to test the null hypothesis that the percentage change from Baseline was equal to zero against the alternative hypothesis that the percentage change from Baseline was not equal to zero.||-45.9612|-61.8590|<0.0001
74095543|NCT02603393|147740643|SUPERIORITY||Ratio of rates|1.08||||0.5802||95.0|0.83|1.4||2 sided|Generalized Linear Model Analysis|||||1.40|0.83|0.5802
74095544|NCT02603393|147740644|SUPERIORITY||Ratio of rates|1.08||||0.5651|TWO_SIDED|95.0|0.82|1.43||2-sided|Generalized Linear Model Analysis|||||1.43|0.82|0.5651
74095545|NCT02603393|147740645|SUPERIORITY||Ratio of rates|1.02||||0.9665|TWO_SIDED|95.0|0.44|2.34||2-sided|Generalized Linear Model Analysis|||||2.34|0.44|0.9665
74095546|NCT02603393|147740646|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.0573||95.0|-0.053|0.001||2-Sided|Mixed Model for Repeated Measures Analys|||||0.001|-0.053|0.0573
74095547|NCT02603393|147740647|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.0022||95.0|0.7|3.0||2-Sided|Mixed Model for Repeated Measures Analys|||||3.0|0.7|0.0022
74095548|NCT02603393|147740648|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.0221|TWO_SIDED|95.0|0.2|2.6||2-Sided|Mixed Model for Repeated measures Analys|||||2.6|0.2|0.0221
74095549|NCT02603393|147740649|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.1724||95.0|-0.587|0.105|||Mixed Model for Repeated Measures Analys|||||0.105|-0.587|0.1724
74095550|NCT02603393|147740650|SUPERIORITY||Mean Difference (Final Values)|-0.288||||0.1055||95.0|-0.638|0.061||2-Sided|Mixed Model for Repated Measures Analysi|||||0.061|-0.638|0.1055
74095551|NCT02603393|147740651|SUPERIORITY||Mean Difference (Final Values)|0.177||||0.0641||95.0|-0.01|0.365||2-Sided|Linear Mixed Model Analysis|||||0.365|-0.010|0.0641
74095552|NCT02603393|147740652|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.4107|TWO_SIDED|95.0|-0.025|0.061||2-Sided|Mixed Model for Repeated Measures Analys|||||0.061|-0.025|0.4107
74045171|NCT00937326|147642230|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 22.||||0.999
74045172|NCT00937326|147642230|SUPERIORITY|||||||0.629||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 22.||||0.629
74045173|NCT00937326|147642230|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 28.||||0.982
74045174|NCT00937326|147642230|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 28.||||0.982
73880290|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.94||||0.0068|TWO_SIDED|95.0|1.55|15.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.68|1.55|0.0068
74015861|NCT04986202|147583061|SUPERIORITY||Mean Difference (Final Values)|-0.92||||0.537|TWO_SIDED|95.0|-3.86|2.02||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||2.02|-3.86|0.537
74015862|NCT04986202|147583061|SUPERIORITY||Mean Difference (Final Values)|-1.81||||0.221|TWO_SIDED|95.0|-4.71|1.09||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||1.09|-4.71|0.221
74015863|NCT04986202|147583062|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.559|TWO_SIDED|95.0|-5.7|10.5||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||10.5|-5.7|0.559
74015864|NCT04986202|147583062|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.195|TWO_SIDED|95.0|-2.7|13.3||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||13.3|-2.7|0.195
74015865|NCT04986202|147583063|SUPERIORITY||Mean Difference (Final Values)|-1.65||||0.289|TWO_SIDED|95.0|-4.71|1.41||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.41|-4.71|0.289
74015866|NCT04986202|147583063|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.571|TWO_SIDED|95.0|-3.86|2.13||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||2.13|-3.86|0.571
74015867|NCT04986202|147583063|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.89|TWO_SIDED|95.0|-3.8|3.3||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||3.30|-3.80|0.890
74015868|NCT04986202|147583063|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.558|TWO_SIDED|95.0|-4.55|2.46||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||2.46|-4.55|0.558
74015869|NCT04986202|147583064|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.619|TWO_SIDED|95.0|-11.1|6.6||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||6.6|-11.1|0.619
74015870|NCT04986202|147583064|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.522|TWO_SIDED|95.0|-5.8|11.4||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||11.4|-5.8|0.522
74045175|NCT00937326|147642230|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 28.||||0.999
74045176|NCT00937326|147642230|SUPERIORITY|||||||0.874||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 28.||||0.874
74015871|NCT04986202|147583064|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.267|TWO_SIDED|95.0|-4.4|15.8||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||15.8|-4.4|0.267
74015872|NCT04986202|147583064|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.657|TWO_SIDED|95.0|-7.6|12.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||12.1|-7.6|0.657
74015873|NCT04986202|147583065|SUPERIORITY||Geometric mean ratio|0.95||||0.312|TWO_SIDED|95.0|0.86|1.05||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 16 weeks||1.05|0.86|0.312
74015874|NCT04986202|147583065|SUPERIORITY||Geometric mean ratio|0.91||||0.07|TWO_SIDED|95.0|0.83|1.01||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 16 weeks||1.01|0.83|0.070
74015875|NCT04986202|147583065|SUPERIORITY||Geometric mean ratio|1.01||||0.911|TWO_SIDED|95.0|0.91|1.12||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 24 weeks||1.12|0.91|0.911
74015876|NCT04986202|147583065|SUPERIORITY||Geometric mean ratio|1.01||||0.837|TWO_SIDED|95.0|0.91|1.12||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 24 weeks||1.12|0.91|0.837
74015877|NCT04986202|147583065|SUPERIORITY||Geometric mean ratio|0.95||||0.37|TWO_SIDED|95.0|0.84|1.07||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 48 weeks||1.07|0.84|0.370
74015878|NCT04986202|147583065|SUPERIORITY||Geometric mean ratio|0.93||||0.205|TWO_SIDED|95.0|0.83|1.04||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 48 weeks||1.04|0.83|0.205
74015879|NCT04986202|147583066|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.183|TWO_SIDED|95.0|-0.2|1.2||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.2|-0.2|0.183
74045177|NCT00937326|147642230|SUPERIORITY|||||||0.986||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 35.||||0.986
74045178|NCT00937326|147642230|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 35.||||0.997
74095553|NCT01783548|147740658|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.66||||0.002|TWO_SIDED|95.0|-1.08|-0.24||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||Based on other studies, the standard deviation for the change from baseline over the first 6 weeks of treatment in the average of AM and PM rTNSS is assumed to be 2.0. Using this standard deviation, 450 subjects aged 6 to 11 years (300 on active treatment of BDP and 150 on placebo) provide approximately 90% power to detect a difference of 0.65 in rTNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.||-0.24|-1.08|0.002
74015880|NCT04986202|147583066|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.898|TWO_SIDED|95.0|-0.8|0.7||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||0.7|-0.8|0.898
74015881|NCT04986202|147583066|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.316|TWO_SIDED|95.0|-0.4|1.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.1|-0.4|0.316
74015882|NCT04986202|147583066|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.934|TWO_SIDED|95.0|-0.7|0.8||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||0.8|-0.7|0.934
74015883|NCT04986202|147583067|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.725|TWO_SIDED|95.0|-1.647|2.366||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||2.366|-1.647|0.725
74045179|NCT00937326|147642230|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 35.||||1.000
74015884|NCT04986202|147583067|SUPERIORITY||Mean Difference (Final Values)|-0.594||||0.555|TWO_SIDED|95.0|-2.571|1.382||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.382|-2.571|0.555
74015885|NCT04986202|147583067|SUPERIORITY||Mean Difference (Final Values)|0.657||||0.586|TWO_SIDED|95.0|-1.71|3.025||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||3.025|-1.710|0.586
74015886|NCT04986202|147583067|SUPERIORITY||Mean Difference (Final Values)|-0.815||||0.486|TWO_SIDED|95.0|-3.108|1.478||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.478|-3.108|0.486
74015887|NCT04986202|147583068|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.968|TWO_SIDED|95.0|-4.1|3.9||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||3.9|-4.1|0.968
74015888|NCT04986202|147583068|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.251|TWO_SIDED|95.0|-6.3|1.6||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.6|-6.3|0.251
74015889|NCT04986202|147583068|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.872|TWO_SIDED|95.0|-4.8|5.7||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||5.7|-4.8|0.872
74015890|NCT04986202|147583068|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.682|TWO_SIDED|95.0|-6.2|4.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|No formal hypothesis testing and p-value is not adjusted for multiple comparisons.|Change from baseline at 24 weeks||4.1|-6.2|0.682
74015891|NCT04986202|147583070|SUPERIORITY||Geometric mean ratio|1.029||||0.76|TWO_SIDED|95.0|0.857|1.236||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.236|0.857|0.760
74015892|NCT04986202|147583070|SUPERIORITY||Geometric mean ratio|1.209||||0.039|TWO_SIDED|95.0|1.01|1.448||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Change from baseline at 16 weeks||1.448|1.010|0.039
74015893|NCT04986202|147583070|SUPERIORITY||Geometric mean ratio|1.111||||0.241|TWO_SIDED|95.0|0.931|1.326||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.326|0.931|0.241
74045180|NCT00937326|147642230|SUPERIORITY|||||||0.697||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 35.||||0.697
74045181|NCT00937326|147642231|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPG.||||1.000
74095554|NCT01783548|147740659|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.58||||0.004|TWO_SIDED|95.0|-0.99|-0.18||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.18|-0.99|0.004
74095555|NCT01783548|147740660|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.62||||0.002|TWO_SIDED|95.0|-1.0|-0.23||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.23|-1.00|0.002
74045182|NCT00937326|147642231|SUPERIORITY|||||||0.812||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPG.||||0.812
74015894|NCT04986202|147583070|SUPERIORITY||Geometric mean ratio|1.19||||0.049|TWO_SIDED|95.0|1.001|1.414||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.414|1.001|0.049
74015895|NCT04986202|147583070|SUPERIORITY||Geometric mean ratio|1.151||||0.158|TWO_SIDED|95.0|0.946|1.401||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.401|0.946|0.158
74095556|NCT01783548|147740661|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.54||||0.004|TWO_SIDED|95.0|-0.91|-0.17||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.17|-0.91|0.004
74015896|NCT04986202|147583070|SUPERIORITY||Geometric mean ratio|1.159||||0.131|TWO_SIDED|95.0|0.957|1.404||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.404|0.957|0.131
74015897|NCT04986202|147583071|SUPERIORITY||Geometric mean ratio|1.0111||||0.874|TWO_SIDED|95.0|0.8819|1.1592||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.1592|0.8819|0.874
74015898|NCT04986202|147583071|SUPERIORITY||Geometric mean ratio|0.9157||||0.2|TWO_SIDED|95.0|0.8002|1.0479||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.0479|0.8002|0.200
74015899|NCT04986202|147583071|SUPERIORITY||Geometric mean ratio|1.1063||||0.135|TWO_SIDED|95.0|0.969|1.2631||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.2631|0.9690|0.135
74015900|NCT04986202|147583071|SUPERIORITY||Geometric mean ratio|1.0842||||0.22|TWO_SIDED|95.0|0.9527|1.2339||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.2339|0.9527|0.220
74015901|NCT04986202|147583071|SUPERIORITY||Geometric mean ratio|1.0496||||0.467|TWO_SIDED|95.0|0.9211|1.196||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.1960|0.9211|0.467
74015902|NCT04986202|147583071|SUPERIORITY||Geometric mean ratio|1.0312||||0.636|TWO_SIDED|95.0|0.908|1.1711||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.1711|0.9080|0.636
74015903|NCT02118792|147583081|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
74015904|NCT02787863|147583099|OTHER||||||<|0.05|||||||McNemar|||||||<0.05
74015905|NCT02787863|147583100|OTHER||||||<|0.05|||||||McNemar|||||||<0.05
74015906|NCT02163434|147583123|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
74015907|NCT02163434|147583124|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
74015908|NCT02163434|147583125|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
74015909|NCT02163434|147583127|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
74015910|NCT02163434|147583128|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
74015911|NCT01903837|147583137|EQUIVALENCE|Equivalence margin of 10 points|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.17||0.3|TWO_SIDED|95.0|-2.0|2.6|||Least Square Mean Difference|||||2.6|-2.0|0.3
74015912|NCT01903837|147583138|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
74015913|NCT01903837|147583138|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74015914|NCT01903837|147583139|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
74015915|NCT01903837|147583139|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74015916|NCT01081795|147583166|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.4||||0.1646|TWO_SIDED|95.0|-1.0|0.2||Analysis of covariance (ANCOVA) method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.1646
74015917|NCT01081795|147583166|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.4479|TWO_SIDED|95.0|-0.8|0.4||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.4|-0.8|0.4479
74095557|NCT00988442|147740662|SUPERIORITY_OR_OTHER|||||||1||||||Two-sided 5% significance level.|Fisher Exact|||A Fisher's exact test was used to compare the proportion of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL at week 48 between the standard of care and standard of care + enhanced telephone support groups.||||1.000
74095558|NCT05084716|147740718|SUPERIORITY||Odds Ratio (OR)|5.03|||<|0.0001|TWO_SIDED|95.0|2.08|12.13|||Regression, Logistic|||||12.13|2.08|<.0001
74095559|NCT05084716|147740718|SUPERIORITY||Odds Ratio (OR)|7.6|||<|0.0001|TWO_SIDED|95.0|3.48|16.59|||Regression, Logistic|||||16.59|3.48|<.0001
74095560|NCT05084716|147740719|SUPERIORITY||Odds Ratio (OR)|12.88|||<|0.0001|TWO_SIDED|95.0|5.96|27.85|||Regression, Logistic|||||27.85|5.96|<.0001
74095561|NCT05084716|147740719|SUPERIORITY||Odds Ratio (OR)|1.78||||0.001|TWO_SIDED|95.0|1.26|2.52|||Regression, Logistic|||||2.52|1.26|.001
74095562|NCT05084716|147740720|SUPERIORITY||Cohen's d for difference in proportions|1.28|||<|0.0001|TWO_SIDED|||||Odds Ratio is undefined and p-value from Fisher's Exact test is reported because 0% of PrEP users had ≥80% medication coverage pre-intervention.|Fisher Exact|||||||<.0001
74015918|NCT01081795|147583167|SUPERIORITY_OR_OTHER||LS mean difference|-0.5||||0.1547|TWO_SIDED|95.0|-1.1|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.1|0.1547
74015919|NCT01081795|147583167|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2624|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.2624
74095563|NCT05084716|147740720|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.34|||Regression, Logistic|||||0.34|0.16|<.0001
74095564|NCT00123474|147740729|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% confidence interval (CI) for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-6.0|11.6||||||6 Month Analysis||11.6|-6.0|
74095565|NCT00123474|147740730|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-6.8|10.6||||||||10.6|-6.8|
74095566|NCT00123474|147740730|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg total daily dose relative to 140 mg total daily dose was deduced if the lower bound of the 95% CI for the difference was greater than or equal to -15%.|Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-8.9|8.5||||||||8.5|-8.9|
74095567|NCT00123474|147740741|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-11.7|15.3||||||6 Month Analysis||15.3|-11.7|
74095568|NCT00123474|147740741|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|4.2|||||TWO_SIDED|95.0|-9.3|17.6||||||6 Month Analysis||17.6|-9.3|
74095569|NCT00123474|147740741|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-11.2|14.1||||||24 Month Analysis||14.1|-11.2|
74095570|NCT00123474|147740741|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-11.2|14.1||||||24 Month Analysis||14.1|-11.2|
74095571|NCT04380090|147740792|SUPERIORITY||Odds Ratio (OR)|1.37||||0.41|TWO_SIDED|95.0|0.65|2.86|||Regression, Logistic||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||2.86|0.65|0.41
74095572|NCT04380090|147740793|SUPERIORITY||Odds Ratio (OR)|0.79||||0.66|TWO_SIDED|95.0|0.28|2.24|||ordinal regression model||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||2.24|0.28|0.66
74015920|NCT01081795|147583168|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2464|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.2464
74015921|NCT01081795|147583168|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.3148|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.3148
74015922|NCT01081795|147583169|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.8762|TWO_SIDED|95.0|-0.6|0.5||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.5|-0.6|0.8762
74015923|NCT01081795|147583169|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.3031|TWO_SIDED|95.0|-0.8|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-0.8|0.3031
74015924|NCT01081795|147583170|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.1145|TWO_SIDED|95.0|-0.7|0.1||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.1|-0.7|0.1145
74015925|NCT01081795|147583170|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.3971|TWO_SIDED|95.0|-0.6|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-0.6|0.3971
74045183|NCT00937326|147642231|SUPERIORITY|||||||0.996||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPG.||||0.996
74045184|NCT00937326|147642231|SUPERIORITY|||||||0.198||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPG.||||0.198
74045185|NCT00937326|147642231|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPG.||||1.000
74045186|NCT00937326|147642231|SUPERIORITY|||||||0.358||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPG.||||0.358
74045187|NCT00937326|147642231|SUPERIORITY|||||||0.852||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPG.||||0.852
74045188|NCT00937326|147642231|SUPERIORITY|||||||0.678||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPG.||||0.678
74045189|NCT00937326|147642231|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPG.||||1.000
74095573|NCT04380090|147740794|SUPERIORITY||Odds Ratio (OR)|1.28||||0.65|TWO_SIDED|95.0|0.45|3.63|||ordinal regression model||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||3.63|0.45|0.65
73888047|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.8986|TWO_SIDED|95.0|-4.2|4.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.8|-4.2|0.8986
74015926|NCT01081795|147583171|SUPERIORITY_OR_OTHER||LS mean difference|-0.5||||0.1866|TWO_SIDED|95.0|-1.3|0.3||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.3|0.1866
74015927|NCT01081795|147583171|SUPERIORITY_OR_OTHER||LS mean difference|-0.6||||0.1507|TWO_SIDED|95.0|-1.4|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.4|0.1507
74015928|NCT01081795|147583173|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.1743|TWO_SIDED|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.1743
74015929|NCT01081795|147583173|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2165|TWO_SIDED|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.2165
74015930|NCT01081795|147583174|SUPERIORITY_OR_OTHER||Percentage difference|5.1||||0.3083|TWO_SIDED|95.0|-3.8|14.0||Month 6|Fisher Exact|||||14.0|-3.8|0.3083
74095574|NCT04380090|147740795|EQUIVALENCE|Equivalence is defined as a p-value greater or equal to 0.05 (no difference between groups)||||||0.47|||||||Chi-squared|||||||0.47
74095575|NCT04380090|147740796|EQUIVALENCE|Equivalence is defined as a p-value greater or equal to 0.05 (no difference between groups)||||||0.99|||||||Fisher Exact|||||||0.99
74095576|NCT03276221|147740868|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.215|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.215
74095577|NCT03276221|147740869|SUPERIORITY||Slope|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.495|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of picking the correct box for the abstinence group above and beyond the monitoring group (positive values indicate better memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.495
74095578|NCT03276221|147740870|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.14||0.05|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.050
74095579|NCT03276221|147740871|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.12||0.532|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.532
74015931|NCT01081795|147583174|SUPERIORITY_OR_OTHER||Percentage difference|2.0||||0.7235|TWO_SIDED|95.0|-6.6|10.6||Month 6|Fisher Exact|||||10.6|-6.6|0.7235
73888048|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.3641|TWO_SIDED|95.0|-2.5|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.7|-2.5|0.3641
74095580|NCT03276221|147740872|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.07||0.226|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.226
74095581|NCT03276221|147740873|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.369|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.369
74095582|NCT03276221|147740874|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.647|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.647
73888049|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.9674|TWO_SIDED|95.0|-4.6|4.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.4|-4.6|0.9674
74045190|NCT00937326|147642231|SUPERIORITY|||||||0.191||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPG.||||0.191
74045191|NCT00937326|147642231|SUPERIORITY|||||||0.805||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPG.||||0.805
74045192|NCT00937326|147642231|SUPERIORITY|||||||0.96||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPG.||||0.960
74045193|NCT00937326|147642231|SUPERIORITY|||||||0.985||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPI.||||0.985
74045194|NCT00937326|147642231|SUPERIORITY|||||||0.733||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPI.||||0.733
74015932|NCT00143455|147583176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.236||||0.0556||95.0|0.995|1.536|||Cox Proportional Hazard Model|||A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.||1.536|0.995|0.0556
74015933|NCT00143455|147583177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.343||||0.143||95.0|0.905|1.993|||Chi-squared|||||1.993|0.905|0.143
74015934|NCT00143455|147583178|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.|Hazard Ratio (HR)|1.35||||0.011||95.0|1.071|1.701|||Cox Proportional Hazard Model|||||1.701|1.071|0.0110
74015935|NCT00143455|147583179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.354||||0.0831||95.0|0.961|1.908|||Cox Proportional Hazard Model|||||1.908|0.961|0.0831
74045195|NCT00937326|147642231|SUPERIORITY|||||||0.365||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPI.||||0.365
74045196|NCT00937326|147642231|SUPERIORITY|||||||0.413||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPI.||||0.413
74045197|NCT00937326|147642231|SUPERIORITY|||||||0.765||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPI.||||0.765
74045198|NCT00937326|147642231|SUPERIORITY|||||||0.434||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPI.||||0.434
74095583|NCT03276221|147740875|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.511|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.511
74015936|NCT00143455|147583180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.965||||0.7544||95.0|0.771|1.208|||Cox Proportional Hazard Model|||||1.208|0.771|0.7544
74015937|NCT03099707|147583192|SUPERIORITY||Risk Ratio (RR)|5.2||||0.105|TWO_SIDED|95.0|0.6|43.0|||Fisher Exact|||||43|0.6|0.105
74015938|NCT01459705|147583229|SUPERIORITY_OR_OTHER||Slope|-22.34|STANDARD_DEVIATION|4.69|||ONE_SIDED|||||||||||||
74045199|NCT00937326|147642231|SUPERIORITY|||||||0.184||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPI.||||0.184
74015939|NCT01459705|147583229|SUPERIORITY_OR_OTHER||Slope|-13.3|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|||||||||||||
74015940|NCT01459705|147583229|SUPERIORITY_OR_OTHER||Slope|9.04|STANDARD_ERROR_OF_MEAN|5.11|||TWO_SIDED|||||||||||||
74015941|NCT01459705|147583230|SUPERIORITY_OR_OTHER||Slope|15.07|STANDARD_DEVIATION|6.03|||TWO_SIDED|||||||||||||
74015942|NCT01459705|147583231|SUPERIORITY_OR_OTHER||Slope|13.91|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|||||||||||||
74015943|NCT01967537|147583322|SUPERIORITY|||||||0.23|||||||Mann-Whitney|||||||0.23
74015944|NCT04417894|147583349|SUPERIORITY||||||=|0.003|||||||Cochran-Mantel-Haenszel|||||||=0.0030
74015945|NCT04417894|147583350|SUPERIORITY||Difference|38.6|||<|0.0001|TWO_SIDED|95.0|24.06|53.15|||Mantel Haenszel|||||53.15|24.06|<0.0001
74015946|NCT05130463|147583370|OTHER|||||||0.0011||||||Comparison of the change in HbA1c from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|||||||0.0011
74015947|NCT05130463|147583371|OTHER|||||||0.0014||||||Comparison of the change in HbA1c from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|||||||0.0014
74015948|NCT05130463|147583376|OTHER|||||||0.0008||||||Comparison of the change in FPG from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||FPG at baseline vs FPG after 12 weeks of treatment.||||0.0008
74015949|NCT05130463|147583377|OTHER|||||||0.0068||||||Comparison of the change in FPG from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||FPG at baseline vs FPG after 24 weeks of treatment.||||0.0068
74015950|NCT05130463|147583378|OTHER|||||||0.1867||||||Comparison of the change in body weight from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level||Body weight at baseline vs Body weight after 12 weeks of treatment.||||0.1867
74015951|NCT05130463|147583379|OTHER|||||||0.0003||||||Comparison of the change in body weight from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||Body weight at baseline vs Body weight after 24 weeks of treatment.||||0.0003
74015952|NCT05130463|147583380|OTHER|||||||0.002||||||Comparison of the change in SBP from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||SBP at baseline vs SBP after 12 weeks of treatment.||||0.0020
74015953|NCT05130463|147583380|OTHER|||||||0.0132||||||Comparison of the change in DBP from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||DBP at baseline vs DBP after 12 weeks of treatment.||||0.0132
74015954|NCT05130463|147583381|OTHER|||||||0.7591||||||Comparison of the change in SBP from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||SBP at baseline vs SBP after 24 weeks of treatment.||||0.7591
74015955|NCT05130463|147583381|OTHER|||||||0.5161||||||Comparison of the change in DBP from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||DBP at baseline vs DBP after 24 weeks of treatment.||||0.5161
74015956|NCT03461757|147583382|SUPERIORITY||Risk Difference (RD)|10.4|||<|0.0001|TWO_SIDED|95.0|6.5|14.2|||Cochran-Mantel-Haenszel|||||14.2|6.5|< 0.0001
74015957|NCT03461757|147583383|SUPERIORITY||Risk Difference (RD)|8.3||||0.0009|TWO_SIDED|95.0|3.4|13.2|||Cochran-Mantel-Haenszel|||||13.2|3.4|0.0009
74015958|NCT03461757|147583384|SUPERIORITY||Risk Difference (RD)|16.1|||<|0.0001|TWO_SIDED|95.0|10.8|21.3|||Cochran-Mantel-Haenszel|||||21.3|10.8|< 0.0001
74015959|NCT03461757|147583385|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|15.1|25.2|||Cochran-Mantel-Haenszel|||||25.2|15.1|< 0.0001
74015960|NCT03461757|147583386|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|15.1|25.2|||Cochran-Mantel-Haenszel|||||25.2|15.1|< 0.0001
74015961|NCT03461757|147583387|SUPERIORITY||Risk Difference (RD)|9.3|||<|0.0001|TWO_SIDED|95.0|4.9|13.7|||Cochran-Mantel-Haenszel|||||13.7|4.9|< 0.0001
74015962|NCT03461757|147583388|SUPERIORITY||Risk Difference (RD)|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.3|-10.7|||Cochran-Mantel-Haenszel|||||-10.7|-19.3|< 0.0001
74015963|NCT03461757|147583389|SUPERIORITY||Risk Difference (RD)|12.7|||<|0.0001|TWO_SIDED|95.0|8.3|17.2|||Cochran-Mantel-Haenszel|||||17.2|8.3|< 0.0001
74015964|NCT03461757|147583390|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.0001|TWO_SIDED|95.0|12.0|21.9|||Cochran-Mantel-Haenszel|||||21.9|12.0|< 0.0001
74015965|NCT03461757|147583391|SUPERIORITY||Risk Difference (RD)|6.8||||0.0018|TWO_SIDED|95.0|2.5|11.0|||Cochran-Mantel-Haenszel|||||11.0|2.5|0.0018
74015966|NCT03461757|147583392|SUPERIORITY||Risk Difference (RD)|10.6|||<|0.0001|TWO_SIDED|95.0|6.3|14.9|||Cochran-Mantel-Haenszel|||||14.9|6.3|< 0.0001
74015967|NCT03461757|147583393|SUPERIORITY||Risk Difference (RD)|8.8||||0.0007|TWO_SIDED|95.0|3.7|13.9|||Cochran-Mantel-Haenszel|||||13.9|3.7|0.0007
74015968|NCT03461757|147583394|SUPERIORITY||Risk Difference (RD)|8.9||||0.0002|TWO_SIDED|95.0|4.3|13.6|||Cochran-Mantel-Haenszel|||||13.6|4.3|0.0002
74015969|NCT03461757|147583395|SUPERIORITY||Risk Difference (RD)|12.4|||<|0.0001|TWO_SIDED|95.0|7.1|17.6|||Cochran-Mantel-Haenszel|||||17.6|7.1|< 0.0001
74015970|NCT03461757|147583396|SUPERIORITY||Risk Difference (RD)|10.1|||<|0.0001|TWO_SIDED|95.0|6.9|13.4|||Cochran-Mantel-Haenszel|||||13.4|6.9|< 0.0001
74015971|NCT03461757|147583397|SUPERIORITY||Risk Difference (RD)|5.8||||0.0128|TWO_SIDED|95.0|1.2|10.4|||Cochran-Mantel-Haenszel|||||10.4|1.2|0.0128
74015972|NCT03461757|147583398|SUPERIORITY||Risk Difference (RD)|7.8|||<|0.0001|TWO_SIDED|95.0|4.4|11.1|||Cochran-Mantel-Haenszel|||||11.1|4.4|< 0.0001
74015973|NCT03461757|147583399|SUPERIORITY||Risk Difference (RD)|11.5||||0.0003|TWO_SIDED|95.0|5.3|17.7|||Cochran-Mantel-Haenszel|||||17.7|5.3|0.0003
74045200|NCT00937326|147642231|SUPERIORITY|||||||0.142||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPI.||||0.142
74045201|NCT00937326|147642231|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPI.||||0.999
74045202|NCT00937326|147642231|SUPERIORITY|||||||0.876||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPI.||||0.876
74045203|NCT00937326|147642231|SUPERIORITY|||||||0.756||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPI.||||0.756
74015974|NCT03461757|147583400|SUPERIORITY||Risk Difference (RD)|8.0|||<|0.0001|TWO_SIDED|95.0|4.9|11.1|||Cochran-Mantel-Haenszel|||||11.1|4.9|< 0.0001
74015975|NCT03461757|147583401|SUPERIORITY||Risk Difference (RD)|5.5||||0.0314|TWO_SIDED|95.0|0.5|10.6|||Cochran-Mantel-Haenszel|||||10.6|0.5|0.0314
74015976|NCT03461757|147583402|SUPERIORITY||Risk Difference (RD)|6.4||||0.0025|TWO_SIDED|95.0|2.3|10.6|||Cochran-Mantel-Haenszel|||||10.6|2.3|0.0025
74015977|NCT03461757|147583403|SUPERIORITY||Risk Difference (RD)|5.9||||0.0898|TWO_SIDED|95.0|-0.9|12.7||P-Value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.7|-0.9|0.0898
74015978|NCT00487539|147583412|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74045204|NCT00937326|147642231|SUPERIORITY|||||||0.983||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPI.||||0.983
74045205|NCT00937326|147642232|SUPERIORITY|||||||0.809||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 30 minutes.||||0.809
74045206|NCT00937326|147642232|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 30 minutes.||||1.000
74045207|NCT00937326|147642232|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 30 minutes.||||0.989
74045208|NCT00937326|147642232|SUPERIORITY|||||||0.13||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 30 minutes.||||0.130
74045209|NCT00937326|147642232|SUPERIORITY|||||||0.87||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 60 minutes.||||0.870
74045210|NCT00937326|147642232|SUPERIORITY|||||||0.864||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 60 minutes.||||0.864
74045211|NCT00937326|147642232|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 60 minutes.||||0.997
74015979|NCT00487539|147583412|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74015980|NCT00487539|147583413|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74015981|NCT00487539|147583413|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74015982|NCT00487539|147583414|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Chi-squared|||||||0.0014
74015983|NCT00487539|147583414|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
74015984|NCT00487539|147583415|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores||||||<0.0001
74015985|NCT00487539|147583415|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores||||||<0.0001
74015986|NCT03440814|147583416|SUPERIORITY||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|1.294||0.1983|TWO_SIDED|95.0|-4.24|0.89|||Mixed Models Analysis|MMRM analysis adjusted for baseline growth hormone use and HQ-CT total score. All available subject data were used with no imputation of missing data.|alpha=0.05 level of significance|||0.89|-4.24|0.1983
74015987|NCT03440814|147583417|SUPERIORITY|||||||0.0294|||||||Cochran-Mantel-Haenszel|Treatment groups were compared using CMH mean score test with modified ridit scores, stratified by the randomization stratification variables.||||||0.0294
74015988|NCT03440814|147583418|SUPERIORITY|||||||0.4089|||||||Cochran-Mantel-Haenszel|Treatment groups were compared using CMH mean score test with modified ridit scores, stratified by the randomization stratification variables.||||||0.4089
74015989|NCT03440814|147583419|SUPERIORITY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.458||0.0225|TWO_SIDED|95.0|-1.95|-0.15|||ANCOVA|ANCOVA adjusted for baseline body fat mass value as a covariate, and randomization stratification variables (as randomized) as factors.||||-0.15|-1.95|0.0225
74015990|NCT03440814|147583420|SUPERIORITY||Mean Difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|1.481||0.0369|TWO_SIDED|95.0|-6.06|-0.19|||Mixed Models Analysis|Linear mixed model for repeated measurements was used. All available data collected before the March 1, 2020 cutoff from each subject were included.|alpha=0.05 level of significance|||-0.19|-6.06|0.0369
74015991|NCT00879697|147583421|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The effect of training in both groups were assessed by a 2-way ANOVA (Time x Group) for repeated measures. When significance was obtained, the Newman-Keuls post hoc test was used to identify the differences.||||<0.05
74015992|NCT00720109|147583430|SUPERIORITY_OR_OTHER_LEGACY||Percentage|40.7|||<|0.001|TWO_SIDED|90.0|30.8|51.4|||Chi-squared|Chi-squared test equivalent to Z-test of proportions.||The a priori plan was to compare MRD positivity rate with that on a prior study, AALL0031 (n=72 Cohorts 1-5 of AALL0031 with 71% MRD positive). Out of 59 patients with end-Induction MRD on AALL0622, 40.7% were MRD positive. Per protocol, rates will be compared with a 2 sample Z-test of proportions, 1-sided test, alpha=5%.||51.4|30.8|<0.001
74015993|NCT00720109|147583431|SUPERIORITY_OR_OTHER_LEGACY||percentage|10.5|||=|0.13|TWO_SIDED|90.0|5.3|19.3|||Binomial Test||The pre-specified threshold for the estimated percentage of MRD positivity at End Consolidation was set to 16%. Results show an upper bound on the (Agresti-Coull) confidence interval of 19.3%.|||19.3|5.3|=0.13
74015994|NCT00371865|147583433|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||.27
74015995|NCT00371865|147583434|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||||||.90
74015996|NCT00371865|147583435|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||.13
73888050|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.5744|TWO_SIDED|95.0|-3.2|5.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-3.2|0.5744
74045212|NCT00937326|147642232|SUPERIORITY|||||||0.682||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 60 minutes.||||0.682
74045213|NCT00937326|147642232|SUPERIORITY|||||||0.798||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 2 hour.||||0.798
74045214|NCT00937326|147642232|SUPERIORITY|||||||0.73||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 2 hour.||||0.730
74045215|NCT00937326|147642232|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 2 hour.||||1.000
74045216|NCT00937326|147642232|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 2 hour.||||1.000
74045217|NCT00937326|147642232|SUPERIORITY|||||||0.464||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 30 minutes.||||0.464
74045218|NCT00937326|147642232|SUPERIORITY|||||||0.634||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 30 minutes.||||0.634
74045219|NCT00937326|147642232|SUPERIORITY|||||||0.254||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 30 minutes.||||0.254
74045220|NCT00937326|147642232|SUPERIORITY|||||||0.034||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 30 minutes.||||0.034
74045221|NCT00937326|147642232|SUPERIORITY|||||||0.765||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 60 minutes.||||0.765
74045222|NCT00937326|147642232|SUPERIORITY|||||||0.434||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 60 minutes.||||0.434
74045223|NCT00937326|147642232|SUPERIORITY|||||||0.184||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 60 minutes.||||0.184
74045224|NCT00937326|147642232|SUPERIORITY|||||||0.142||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 60 minutes.||||0.142
74015997|NCT00371865|147583436|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||.26
74015998|NCT00371865|147583437|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||||||.90
74015999|NCT02508194|147583438|SUPERIORITY||Vaccine efficacy|-7.1|||||TWO_SIDED|90.0|-106.9|44.3|||||The CI was estimated by an exact conditional method.|2 sided 90 percent (%) confidence interval (CI) was used to compare vaccine efficacy (VE). VE = (\[1 - relative risk (RR)\] \*100%), where RR was the RR of ARA-RI in the MEDI7510 group compared with the placebo group. A lower bound of the 90% CI greater than (\>) 0% would demonstrate the efficacy of MEDI7510.||44.3|-106.9|
74016000|NCT01564862|147583491|SUPERIORITY_OR_OTHER||LS mean difference|1.75|STANDARD_ERROR_OF_MEAN|0.744||0.019|TWO_SIDED|95.0|0.28|3.21||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||3.21|0.28|0.019
74016001|NCT01564862|147583491|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.733||0.099|TWO_SIDED|95.0|-0.23|2.65||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||2.65|-0.23|0.099
74016002|NCT01564862|147583491|SUPERIORITY_OR_OTHER||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.725||0.46|TWO_SIDED|95.0|-0.89|1.96||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||1.96|-0.89|0.460
74016003|NCT01564862|147583492|SUPERIORITY_OR_OTHER||LS Mean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.001|TWO_SIDED|95.0|-4.1|-1.0||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-1.0|-4.1|0.001
74016004|NCT01564862|147583492|SUPERIORITY_OR_OTHER||LS mean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.77|<|0.001|TWO_SIDED|95.0|-4.5|-1.5||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-1.5|-4.5|<0.001
74016005|NCT01564862|147583493|SUPERIORITY_OR_OTHER||LS Mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1211||0.017|TWO_SIDED|95.0|-0.528|-0.052||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-0.052|-0.528|0.017
74016006|NCT01564862|147583493|SUPERIORITY_OR_OTHER||LS mean difference|-0.404|STANDARD_ERROR_OF_MEAN|0.1194|<|0.001|TWO_SIDED|95.0|-0.638|-0.169||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-0.169|-0.638|<0.001
74016007|NCT00691483|147583590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.03|||<|0.0001|TWO_SIDED|95.0|3.8|9.56||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide \>=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 \[Weeks 9-12\] and 0.18 \[Weeks 9-24\] and Varenicline CA rates of 0.46 \[Weeks 9-12\] and 0.31 \[Weeks 9-24\]) (odds ratio of \>=2.67 \[Weeks 9-12\] and \>=2.10 \[Weeks 9-24\]).||9.56|3.80|<0.0001
74016008|NCT00691483|147583591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.45|||<|0.0001|TWO_SIDED|95.0|2.62|7.55||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide \>=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 \[Weeks 9-12\] and 0.18 \[Weeks 9-24\] and Varenicline CA rates of 0.46 \[Weeks 9-12\] and 0.31 \[Weeks 9-24\]) (odds ratio of \>=2.67 \[Weeks 9-12\] and \>=2.10 \[Weeks 9-24\]).||7.55|2.62|<0.0001
74016009|NCT00691483|147583592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.91|||<|0.0001|TWO_SIDED|95.0|2.96|8.13||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||8.13|2.96|<0.0001
74016010|NCT00691483|147583593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.0001|TWO_SIDED|95.0|3.66|8.75||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 12. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||8.75|3.66|<0.0001
74016011|NCT00691483|147583593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.58|6.58||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 24. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||6.58|2.58|<0.0001
74016012|NCT00691483|147583594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14|||<|0.0001|TWO_SIDED|95.0|2.58|6.67||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||6.67|2.58|<0.0001
74016013|NCT00439946|147583596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.84
73880291|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.49||||0.0741|TWO_SIDED|95.0|0.91|6.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.79|0.91|0.0741
74016014|NCT00439946|147583597|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
74016015|NCT00439946|147583598|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
74016016|NCT00439946|147583599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.50
74016017|NCT00439946|147583600|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.00
74016018|NCT00439946|147583601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.50
74016019|NCT00439946|147583602|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.0
74016020|NCT00439946|147583603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.75
74016021|NCT00439946|147583604|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.0
74016022|NCT00439946|147583605|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.00
74016023|NCT00439946|147583606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0||||p-value for: Gather/set-up|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.95
74016024|NCT00439946|147583606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||p-value for: Prepare drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.02
74016025|NCT00439946|147583606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0||||p-value for: Connect drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.20
74016026|NCT00439946|147583606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0||||p-value for: Change dressing|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.48
74016027|NCT00439946|147583606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||p-value for: Total time|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.11
74016028|NCT00439946|147583607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0||||p-value for: CAMPHOR Symptom Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.31
74016029|NCT00439946|147583607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84||95.0||||p-value for CAMPHOR Activity Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.84
74016030|NCT00439946|147583607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0||||p-value for CAMPHOR Quality of Life Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
74016031|NCT00439946|147583607|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||p-value for CAMPHOR Total Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.22
74016032|NCT00439946|147583608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0||||p-value for TSQM Effectiveness Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.55
74016033|NCT00439946|147583608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0||||p-value for TSQM Side-Effects Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.50
74016034|NCT00439946|147583608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||p-value for TSQM Convenience Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.01
74016035|NCT00439946|147583608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||95.0||||p-value for TSQM Global Satisfaction Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.52
74016036|NCT01535729|147583611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949|STANDARD_ERROR_OF_MEAN|0.167||0.756|TWO_SIDED|95.0|0.684|1.318|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.318|0.684|0.756
74045225|NCT00937326|147642232|SUPERIORITY|||||||0.955||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 2 hour.||||0.955
74045226|NCT00937326|147642232|SUPERIORITY|||||||0.985||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 2 hour.||||0.985
74016037|NCT01535729|147583611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.744|STANDARD_ERROR_OF_MEAN|0.185||0.11|TWO_SIDED|95.0|0.518|1.07|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.070|0.518|0.110
74016038|NCT01535729|147583611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.054|STANDARD_ERROR_OF_MEAN|0.242||0.829|TWO_SIDED|95.0|0.656|1.692|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.692|0.656|0.829
74016039|NCT01535729|147583626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.981|STANDARD_ERROR_OF_MEAN|0.143||0.895|TWO_SIDED|95.0|0.741|1.299|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.299|0.741|0.895
74016040|NCT01535729|147583626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.689|STANDARD_ERROR_OF_MEAN|0.162||0.022|TWO_SIDED|95.0|0.501|0.947|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||0.947|0.501|0.022
74016041|NCT01535729|147583626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162|STANDARD_ERROR_OF_MEAN|0.212||0.479|TWO_SIDED|95.0|0.767|1.759|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.759|0.767|0.479
74016042|NCT01535729|147583627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732|STANDARD_ERROR_OF_MEAN|0.129||0.015|TWO_SIDED|95.0|0.569|0.941|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.||0.941|0.569|0.015
74016043|NCT01535729|147583628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.902|STANDARD_ERROR_OF_MEAN|0.156||0|TWO_SIDED|95.0|1.402|2.582|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.582|1.402|0.000
74016044|NCT01535729|147583628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.786|STANDARD_ERROR_OF_MEAN|0.183||0.002|TWO_SIDED|95.0|1.248|2.557|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.557|1.248|0.002
74016045|NCT01535729|147583631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.15||0.027|TWO_SIDED|95.0|0.535|0.962|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.||0.962|0.535|0.027
74016046|NCT01535729|147583632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.935|STANDARD_ERROR_OF_MEAN|0.179||0|TWO_SIDED|95.0|1.362|2.749|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.749|1.362|0.000
74016047|NCT01535729|147583632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.882|STANDARD_ERROR_OF_MEAN|0.213||0.003|TWO_SIDED|95.0|1.239|2.859|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.859|1.239|0.003
74016048|NCT00130832|147583662|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.5|||<|0.001||95.0|-2.2|1.4|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 1||1.4|-2.2|<0.001
74016049|NCT00130832|147583662|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|0.0|||<|0.001||95.0|-1.4|1.6|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 2||1.6|-1.4|<0.001
74045227|NCT00937326|147642232|SUPERIORITY|||||||0.923||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 2 hour.||||0.923
74045228|NCT00937326|147642232|SUPERIORITY|||||||0.883||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 2 hour.||||0.883
74016050|NCT00130832|147583662|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.1|||<|0.001||95.0|-2.3|2.3|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 3||2.3|-2.3|<0.001
74045229|NCT00937326|147642233|SUPERIORITY|||||||0.118||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.118
74045230|NCT00937326|147642233|SUPERIORITY|||||||0.119||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.119
74045231|NCT00937326|147642233|SUPERIORITY|||||||0.293||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.293
74045232|NCT00937326|147642233|SUPERIORITY|||||||0.966||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.966
74045233|NCT00937326|147642234|SUPERIORITY|||||||0.94||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.940
74045234|NCT00937326|147642234|SUPERIORITY|||||||0.197||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.197
74045235|NCT00937326|147642234|SUPERIORITY|||||||0.097||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.097
74045236|NCT00937326|147642234|SUPERIORITY|||||||0.404||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.404
74045237|NCT00937326|147642235|SUPERIORITY|||||||0.206||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPG.||||0.2060
74045238|NCT00937326|147642235|SUPERIORITY|||||||0.179||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPG.||||0.1790
74045239|NCT00937326|147642235|SUPERIORITY|||||||0.2741||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPG.||||0.2741
74045240|NCT00937326|147642235|SUPERIORITY|||||||0.6001||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPG.||||0.6001
74045241|NCT00937326|147642235|SUPERIORITY|||||||0.6711||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPG.||||0.6711
74045242|NCT00937326|147642235|OTHER|||||||0.1361||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPG.||||0.1361
74045243|NCT00937326|147642235|SUPERIORITY|||||||0.3369||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPG.||||0.3369
74045244|NCT00937326|147642235|SUPERIORITY|||||||0.0975||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 28 for PPG.||||0.0975
74045245|NCT00937326|147642235|SUPERIORITY|||||||0.2184||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPG.||||0.2184
74045246|NCT00937326|147642235|SUPERIORITY|||||||0.1013||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPG.||||0.1013
74045247|NCT00937326|147642235|SUPERIORITY|||||||0.3286||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPG.||||0.3286
74045248|NCT00937326|147642235|SUPERIORITY|||||||0.5193||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPG.||||0.5193
74045249|NCT00937326|147642235|SUPERIORITY|||||||0.9788||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPG.||||0.9788
74045250|NCT00937326|147642235|SUPERIORITY|||||||0.1214||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPG.||||0.1214
74045251|NCT00937326|147642235|SUPERIORITY|||||||0.5751||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPG.||||0.5751
74045252|NCT00937326|147642235|SUPERIORITY|||||||0.2409||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPG.||||0.2409
74045253|NCT00937326|147642235|SUPERIORITY|||||||0.4829||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPI.||||0.4829
74045254|NCT00937326|147642235|SUPERIORITY|||||||0.7563||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPI.||||0.7563
74095584|NCT03276221|147740876|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.312|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.312
74095585|NCT03276221|147740877|SUPERIORITY||Slope|1.92|STANDARD_ERROR_OF_MEAN|9.27||0.836|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate higher slower responses for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.836
74095586|NCT03276221|147740878|SUPERIORITY||Slope|-0.5|STANDARD_ERROR_OF_MEAN|3.93||0.898|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median incongruency cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for incongruent trials for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.898
74095587|NCT03276221|147740879|SUPERIORITY||Slope|16.54|STANDARD_ERROR_OF_MEAN|9.05||0.068|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the multitasking cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for multitasking trials for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.068
74016051|NCT00130832|147583663|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the GMT ratio (concomitant group over staggered group) greater than 0.50.|GMT Ratio|0.54||||0.277||95.0|0.42|0.69|||ANOVA|ANOVA model on log titer of serum anti-rotavirus IgA||||0.69|0.42|0.277
74016052|NCT00130832|147583663|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve 3-fold rise in serum anti-rotavirus IgA greater than -10%.|Percentage Point Difference|-4.4||||0.002||95.0|-8.0|-1.4|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method.|Percentage point difference (concomitant - staggered)|||-1.4|-8.0|0.002
74016053|NCT02354703|147583670|SUPERIORITY|||||||0.94||||||a priori significance P\<0.05|Kruskal-Wallis|adjusted for baseline value||||||0.94
74016054|NCT02354703|147583671|SUPERIORITY|||||||1||||||a priori significance is P\<0.05|Chi-squared|adjusted for baseline value||||||1.00
74016055|NCT02354703|147583672|SUPERIORITY|||||||0.73||||||a priori threshold is P\<0.05|Kruskal-Wallis|adjusted for baseline value||||||0.73
74016056|NCT02944448|147583673|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7093|TWO_SIDED|95.0|-0.4|0.5|||Mixed Models Analysis|||||0.5|-0.4|0.7093
74016057|NCT02944448|147583674|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.6007|TWO_SIDED|95.0|-13.1|7.6|||Mixed Models Analysis|||||7.6|-13.1|0.6007
74016058|NCT02944448|147583675|SUPERIORITY||Median Difference (Final Values)|-0.8||||0.4563|TWO_SIDED|95.0|-3.0|1.4|||Mixed Models Analysis|||||1.4|-3.0|0.4563
74016059|NCT02944448|147583676|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.8693|TWO_SIDED|95.0|-1.0|0.8|||Mixed Models Analysis|||||0.8|-1.0|0.8693
74016060|NCT02944448|147583677|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.6516|TWO_SIDED|95.0|-9.1|5.7|||Mixed Models Analysis|||||5.7|-9.1|0.6516
74016061|NCT02944448|147583678|SUPERIORITY||Odds Ratio (OR)|0.7||||0.1033|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|Logistic regression, including treatment, baseline weekly pain score, and OA joint as independent variables.|Ratio between treatment odds of achieving a treatment response.|||1.1|0.5|0.1033
74016062|NCT02944448|147583679|SUPERIORITY||Odds Ratio (OR)|0.8||||0.2831|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|Logistic regression, including treatment, baseline weekly pain score, and OA joint as independent variables.|Ratio between treatment odds of achieving a treatment response.|||1.2|0.5|0.2831
74016063|NCT02944448|147583680|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1959|TWO_SIDED|95.0|0.9|2.0|||Regression, Logistic|Logistic regression with treatment as a main effect and OA joint as a covariate.|"Ratio between treatment odds of having a PGIC of Very Much Improved or Much Improved."|||2.0|0.9|0.1959
74016064|NCT02944448|147583681|SUPERIORITY|||||||0.2858|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test stratified by Primary OA joint (Hip or Knee) and Baseline Week Mean of the Daily NRS (\<6.7 or \>=6.7) (Van Elteren test).||||||0.2858
74016065|NCT02944448|147583682|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8002|TWO_SIDED|95.0|0.3|2.7|||Regression, Logistic|Logistic regression, including treatment, baseline pain score, and OA joint as independent variables.|Ratio between treatment odds of withdrawing from treatment due to lack of analgesic efficacy.|||2.7|0.3|0.8002
74016066|NCT03118297|147583718|SUPERIORITY|||||||0.002||||||Threshold for significance: p=0.05|Wilcoxon (Mann-Whitney)|||||||0.002
74016067|NCT03118297|147583719|SUPERIORITY|||||||0.032||||||Threshold for significance: p=0.05|Fisher Exact|||||||0.032
74016068|NCT03118297|147583720|SUPERIORITY||||||<|0.001||||||Threshold for significance: p=0.05|Fisher Exact|||||||<0.001
74016069|NCT03118297|147583721|SUPERIORITY||||||>|0.05||||||Threshold for significance: p=0.05|Chi-squared|||||||>0.05
74016070|NCT03118297|147583722|OTHER|No statistical test performed|||||||||||||||||Significance testing not performed. All values below prespecified limit of 5.0 ng/mL.|||
74016071|NCT04283123|147583744|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.41|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
74016072|NCT04283123|147583744|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.45|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
74016073|NCT04283123|147583745|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.48|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
74016074|NCT04283123|147583745|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.32|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
74016075|NCT04283123|147583746|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.6|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
74016076|NCT04283123|147583746|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.12|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
74016077|NCT01415752|147583753|SUPERIORITY|||||||0.25||||||one-sided stratified log-rank test|Log Rank|one-sided stratified log-rank test||||||0.25
74016078|NCT01415752|147583754|SUPERIORITY|||||||0.178||||||one-sided stratified log-rank test|Log Rank|one-sided stratified log-rank test||||||0.178
74016079|NCT03066102|147583780|OTHER|||||||0.227||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular elevation. Muscle fatigue would increase reposition error during scapular elevation. One-way repeated measures analysis of variance.||||0.227
74016080|NCT03066102|147583780|OTHER|||||||0.764||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular protraction. Muscle fatigue would increase reposition error during scapular protraction. One-way repeated measures analysis of variance.||||0.764
74016081|NCT03066102|147583781|OTHER|||||||0.413||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.413
74016082|NCT03066102|147583781|OTHER|||||||0.984||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.984
74016083|NCT03066102|147583781|OTHER|||||||0.006||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.006
74016084|NCT03066102|147583781|OTHER|||||||0.154||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.154
74016085|NCT03066102|147583781|OTHER|||||||0.096||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.096
74016086|NCT03066102|147583781|OTHER|||||||0.037||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.037
74016087|NCT03066102|147583782|OTHER|||||||8.5e-05||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of serratus anterior during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.000085
74016088|NCT03066102|147583782|OTHER|||||||0.037||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of upper trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.037
74016089|NCT03066102|147583782|OTHER|||||||0.382||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of lower trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.382
74016090|NCT03066102|147583783|OTHER|||||||0.000467||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular posterior tilt during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular posterior tilt during each angle of scaption.||||0.000467
74016091|NCT03066102|147583783|OTHER|||||||0.093||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.093
74016092|NCT03066102|147583783|OTHER|||||||0.062||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.062
74016093|NCT03066102|147583783|OTHER|||||||0.04||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.04
74045255|NCT00937326|147642235|SUPERIORITY|||||||0.2907||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPI.||||0.2907
74045256|NCT00937326|147642235|SUPERIORITY|||||||0.7663||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPI.||||0.7663
74016094|NCT03066102|147583783|OTHER|||||||0.000147||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.000147
74045257|NCT00937326|147642235|SUPERIORITY|||||||0.5825||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI||||0.5825
74045258|NCT00937326|147642235|SUPERIORITY|||||||0.322||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPI.||||0.3220
74045259|NCT00937326|147642235|SUPERIORITY|||||||0.0564||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPI.||||0.0564
74045260|NCT00937326|147642235|SUPERIORITY|||||||0.196||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI.||||0.1960
74045261|NCT00937326|147642235|SUPERIORITY|||||||0.5997||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPI.||||0.5997
74045262|NCT00937326|147642235|SUPERIORITY|||||||0.9637||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPI.||||0.9637
74045263|NCT00937326|147642235|SUPERIORITY|||||||0.324||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPI.||||0.3240
74045264|NCT00937326|147642235|SUPERIORITY|||||||0.844||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPI.||||0.8440
74045265|NCT00937326|147642235|SUPERIORITY|||||||0.6483||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPI.||||0.6483
74045266|NCT00937326|147642235|SUPERIORITY|||||||0.6452||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPI.||||0.6452
74045267|NCT00937326|147642235|SUPERIORITY|||||||0.1253||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPI.||||0.1253
74045268|NCT00937326|147642235|SUPERIORITY|||||||0.2583||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPI.||||0.2583
74045269|NCT00937326|147642236|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for fructosamine.||||1.000
74045270|NCT00937326|147642236|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for fructosamine.||||1.000
74095588|NCT03276221|147740880|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.1||0.15|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct response for the abstinence group above and beyond the monitoring group (positive values indicate higher accuracy for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.150
74095589|NCT03276221|147740881|SUPERIORITY||Slope|179.11|STANDARD_ERROR_OF_MEAN|281.76||0.525|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.525
74095590|NCT03276221|147740882|SUPERIORITY||Slope|-10.86|STANDARD_ERROR_OF_MEAN|5.24||0.038|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the stop signal task module. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the inhibition latency for the abstinence group above and beyond the monitoring group (positive values indicate slower inhibition for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.038
74095591|NCT03276221|147740883|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.576|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.576
74016095|NCT03066102|147583783|OTHER|||||||1.2e-05||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.000012
74016096|NCT03066102|147583783|OTHER|||||||0.007||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.007
74016097|NCT03066102|147583783|OTHER|||||||0.059||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.059
74016098|NCT03066102|147583783|OTHER|||||||0.032||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.032
74016099|NCT03066102|147583783|OTHER|||||||1.5e-05||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular internal rotation during scaption Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular internal rotation during each angle of scaption.||||0.000015
74016100|NCT03066102|147583783|OTHER|||||||0.296||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.296
74016101|NCT03066102|147583783|OTHER|||||||0.457||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.457
74016102|NCT03066102|147583783|OTHER|||||||0.311||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.311
74016103|NCT03066102|147583783|OTHER|||||||0.004||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.004
74016104|NCT03066102|147583783|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
74016105|NCT03066102|147583783|OTHER|||||||0.137||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.137
74045271|NCT00937326|147642236|SUPERIORITY|||||||0.901||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for fructosamine.||||0.901
74045272|NCT00937326|147642236|SUPERIORITY|||||||0.155||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for fructosamine.||||0.155
74045273|NCT00937326|147642236|SUPERIORITY|||||||0.845||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for fructosamine.||||0.845
74045274|NCT00937326|147642236|SUPERIORITY|||||||0.164||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for fructosamine.||||0.164
74095592|NCT03276221|147740884|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.296|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of trials with strategic responding for the abstinence group above and beyond the monitoring group (positive values indicate higher rates of strategic responding for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.296
74095593|NCT03276221|147740885|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.65|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the discriminability measure for the abstinence group above and beyond the monitoring group (positive values indicate higher discriminability rates for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.650
74045275|NCT00937326|147642236|SUPERIORITY|||||||0.699||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for fructosamine.||||0.699
74045276|NCT00937326|147642236|SUPERIORITY|||||||0.313||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for fructosamine.||||0.313
74045277|NCT00937326|147642237|SUPERIORITY|||||||0.896||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.896
74045278|NCT00937326|147642237|SUPERIORITY|||||||0.08||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.080
74045279|NCT00937326|147642237|SUPERIORITY|||||||0.792||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.792
74045280|NCT00937326|147642237|SUPERIORITY|||||||0.645||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.645
74045281|NCT00937326|147642238|SUPERIORITY|||||||0.992||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-IR.||||0.992
74016106|NCT03066102|147583783|OTHER|||||||0.636||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.636
74016107|NCT03066102|147583783|OTHER|||||||0.406||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.406
74016108|NCT03066102|147583783|OTHER|||||||0.001||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular upward rotation during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular upward rotation during each angle of scaption.||||0.001
74016109|NCT03066102|147583783|OTHER|||||||0.65||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.650
74016110|NCT03066102|147583783|OTHER|||||||0.141||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.141
74016111|NCT03066102|147583783|OTHER|||||||0.021||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.021
74016112|NCT03066102|147583783|OTHER|||||||0.005||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.005
74016113|NCT03066102|147583783|OTHER|||||||0.083||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.083
74016114|NCT03066102|147583783|OTHER|||||||0.389||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.389
74016115|NCT03066102|147583783|OTHER|||||||0.542||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.542
74016116|NCT03066102|147583783|OTHER|||||||0.263||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.263
74016117|NCT03066102|147583784|OTHER|||||||0.331||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of upper trapezius during each angle of scaption."||||0.331
74016118|NCT03066102|147583784|OTHER|||||||0.627||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of lower trapezius during each angle of scaption."||||0.627
74016119|NCT03066102|147583784|OTHER|||||||0.042||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of serratus anterior during each angle of scaption."||||0.042
74016120|NCT03066102|147583784|OTHER|||||||0.021||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 30\~60 degree of scaption.~One-way repeated measures analysis of variance."||||0.021
74045282|NCT00937326|147642238|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-IR.||||0.999
74045283|NCT00937326|147642238|SUPERIORITY|||||||0.548||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-IR.||||0.548
74045284|NCT00937326|147642238|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-IR.||||0.989
74045285|NCT00937326|147642238|SUPERIORITY|||||||0.877||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-IR.||||0.877
74045286|NCT00937326|147642238|SUPERIORITY|||||||0.887||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-IR.||||0.887
74045287|NCT00937326|147642238|SUPERIORITY|||||||0.916||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-IR.||||0.916
74045288|NCT00937326|147642238|SUPERIORITY|||||||0.86||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-IR.||||0.860
74045289|NCT00937326|147642239|SUPERIORITY|||||||0.996||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.996
74045290|NCT00937326|147642239|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.989
74045291|NCT00937326|147642239|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.999
74045292|NCT00937326|147642239|SUPERIORITY|||||||0.763||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.763
74045293|NCT00937326|147642240|SUPERIORITY|||||||0.81||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.810
74045294|NCT00937326|147642240|SUPERIORITY|||||||0.753||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.753
74045295|NCT00937326|147642240|SUPERIORITY|||||||0.404||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.404
74045296|NCT00937326|147642240|SUPERIORITY|||||||0.671||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.671
74045297|NCT00937326|147642240|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-percentage of beta cell function.||||1.000
74045298|NCT00937326|147642240|SUPERIORITY|||||||0.622||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.622
74045299|NCT00937326|147642240|SUPERIORITY|||||||0.332||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.332
74045300|NCT00937326|147642240|SUPERIORITY|||||||0.998||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.998
74095594|NCT03276221|147740886|SUPERIORITY||Slope|-11.64|STANDARD_ERROR_OF_MEAN|9.55||0.223|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate slower responses for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.223
74095595|NCT01791153|147740894|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|42.0|||<|0.0001|TWO_SIDED|99.5|18.0|66.0|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (less than or equal to \[\</=\] 30 mg/day, greater than \[\>\] 30 mg/day).||66.00|18.00|<0.0001
74095596|NCT01791153|147740894|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|39.06|||<|0.0001|TWO_SIDED|99.5|12.46|65.66|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||65.66|12.46|< 0.0001
74095597|NCT01791153|147740895|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||||< 0.0001
74095598|NCT01791153|147740895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was \>/= -22.5%.|Difference in Response Rates|38.35|||||TWO_SIDED|99.5|17.89|58.81||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||58.81|17.89|
74016121|NCT03066102|147583784|OTHER|||||||0.018||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 60\~90 degree of scaption.~One-way repeated measures analysis of variance."||||0.018
74016122|NCT03066102|147583784|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 90\~120 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
74016123|NCT03066102|147583784|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 120\~90 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
74016124|NCT03066102|147583784|OTHER|||||||0.035||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 90\~60 degree of scaption.~One-way repeated measures analysis of variance."||||0.035
74016125|NCT03066102|147583784|OTHER|||||||0.05||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 60\~30 degree of scaption.~One-way repeated measures analysis of variance."||||0.05
74016126|NCT03066102|147583785|OTHER|||||||0.5||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of upper trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.5
74095599|NCT01791153|147740895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||||0.0002
74016127|NCT03066102|147583785|OTHER|||||||0.843||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of lower trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.843
74095600|NCT01791153|147740895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was \>/= -22.5%.|Difference in Response Rates|35.41|||||TWO_SIDED|99.5|10.41|60.41||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||60.41|10.41|
74016128|NCT03066102|147583785|OTHER|||||||0.466||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of serratus anterior during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.466
74016129|NCT01926782|147583801|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-52.4|||<|0.0001|TWO_SIDED|97.5|-59.8|-45.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24||-45.0|-59.8|<0.0001
74045301|NCT00937326|147642241|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.994
74045302|NCT00937326|147642241|SUPERIORITY|||||||0.979||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.979
74045303|NCT00937326|147642241|SUPERIORITY|||||||0.993||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.993
74045304|NCT00937326|147642241|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.999
74045305|NCT02443155|147642265|SUPERIORITY||Treatment ratio|1.48|||=|0.0017|TWO_SIDED|95.0|1.16|1.89|||Mixed model repeated measurements||NNC0114-0006 + liraglutide / Placebo|Ratio of week 54 to baseline are analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.89|1.16|=0.0017
74045306|NCT02443155|147642265|SUPERIORITY||Treatment Ratio|1.23|||=|0.0927|TWO_SIDED|95.0|0.97|1.57|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.57|0.97|=0.0927
74045307|NCT02443155|147642265|SUPERIORITY||Treatment Ratio|1.12|||=|0.378|TWO_SIDED|95.0|0.87|1.42|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.42|0.87|=0.3780
74045308|NCT02443155|147642265|SUPERIORITY||Treatment ratio|1.2|||=|0.1377|TWO_SIDED|95.0|0.94|1.53|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.53|0.94|=0.1377
74095601|NCT01791153|147740896|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|99.0|0.11|0.46|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.46|0.11|<0.0001
74095602|NCT01791153|147740896|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39||||0.0011|TWO_SIDED|99.0|0.18|0.82|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.82|0.18|0.0011
74095603|NCT01791153|147740896|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28||||0.0001|TWO_SIDED|99.0|0.12|0.66|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.66|0.12|0.0001
73880292|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.7||||0.2772|TWO_SIDED|95.0|0.65|4.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.43|0.65|0.2772
74016130|NCT01926782|147583801|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|97.5|-62.3|-48.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Week 21-24||-48.1|-62.3|<0.0001
74016131|NCT01926782|147583802|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-58.7|||<|0.0001|TWO_SIDED|97.5|-65.0|-52.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24||-52.4|-65.0|<0.0001
74016132|NCT01926782|147583802|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-65.0|||<|0.0001|TWO_SIDED|97.5|-70.4|-59.5||Threshold for significance ≤ 0.025|Mixed Models Analysis|||Week 21-24||-59.5|-70.4|< 0.0001
74016133|NCT01926782|147583803|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.0|||<|0.0001|TWO_SIDED|97.5|-64.6|-53.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-53.4|-64.6|<0.0001
74016134|NCT01926782|147583804|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.0|||<|0.0001|TWO_SIDED|97.5|-67.7|-56.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-56.2|-67.7|<0.0001
74016135|NCT01926782|147583805|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.7|||<|0.0001|TWO_SIDED|97.5|-64.5|-53.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.0|-64.5|<0.0001
74016136|NCT01926782|147583806|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.3|||<|0.0001|TWO_SIDED|97.5|-62.3|-50.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50.3|-62.3|<0.0001
74016137|NCT01926782|147583807|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.5|||<|0.0001|TWO_SIDED|97.5|-65.0|-54.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.1|-65.0|<0.0001
74016138|NCT01926782|147583808|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.4|||<|0.0001|TWO_SIDED|97.5|-64.8|-54.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.0|-64.8|<0.0001
74016139|NCT01926782|147583809|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.5|||<|0.0001|TWO_SIDED|97.5|-45.8|-33.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.1|-45.8|<0.0001
74016140|NCT01926782|147583810|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.2|||<|0.0001|TWO_SIDED|97.5|-53.2|-43.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.2|-53.2|<0.0001
74016141|NCT01926782|147583811|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.5|||<|0.0001|TWO_SIDED|97.5|-49.9|-39.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.1|-49.9|<0.0001
74045309|NCT02443155|147642265|SUPERIORITY||Treatment ratio|1.33|||=|0.0214|TWO_SIDED|95.0|1.04|1.69|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.69|1.04|=0.0214
74095604|NCT01791153|147740896|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48||||0.0316|TWO_SIDED|99.0|0.2|1.16|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||1.16|0.20|0.0316
74016142|NCT01926782|147583812|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.3|||<|0.0001|TWO_SIDED|97.5|-55.0|-45.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-45.6|-55.0|<0.0001
74016143|NCT01926782|147583813|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|97.5|-49.9|-36.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.2|-49.9|<0.0001
74016144|NCT01926782|147583814|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.0|||<|0.0001|TWO_SIDED|97.5|-55.3|-44.8||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.8|-55.3|<0.0001
74016145|NCT01926782|147583815|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|97.5|-54.8|-43.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.3|-54.8|<0.0001
74016146|NCT01926782|147583816|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.8|||<|0.0001|TWO_SIDED|97.5|-57.6|-47.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.9|-57.6|<0.0001
74016147|NCT01926782|147583817|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|97.5|-36.6|-26.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-26.3|-36.6|<0.0001
74045310|NCT02443155|147642265|SUPERIORITY||Treatmrnt ratio|1.1|||=|0.4187|TWO_SIDED|95.0|0.87|1.41|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.41|0.87|=0.4187
74045311|NCT02279160|147642383|SUPERIORITY||Multiple imputation|0.742||||0.022|TWO_SIDED|95.0|0.575|0.958|||ANCOVA|||||0.958|0.575|0.0220
74045312|NCT02279160|147642384|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9002|TWO_SIDED|95.0|-28.0|30.0|||Stratified Wilcoxon|||||30.0|-28.0|0.9002
74095605|NCT01791153|147740897|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
74095606|NCT01791153|147740897|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
73880293|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0705|TWO_SIDED|95.0|0.92|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.02|0.92|0.0705
73880294|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.88||||0.022|TWO_SIDED|95.0|1.22|12.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.39|1.22|0.0220
74045313|NCT02853123|147642389|SUPERIORITY||Mean Difference (Final Values)|-0.357|STANDARD_ERROR_OF_MEAN|0.153||0.0217|TWO_SIDED|95.0|-0.661|-0.053|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.053|-0.661|0.0217
74045314|NCT02853123|147642390|SUPERIORITY||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.106|0.265|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured prior to exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.265|0.106|<.0001
74045315|NCT02853123|147642391|SUPERIORITY||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.038||0.0852|TWO_SIDED|95.0|-0.009|0.141|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured end of exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.141|-0.009|0.0852
74045316|NCT02853123|147642392|SUPERIORITY||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.117|0.194|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.194|0.117|<.0001
74045317|NCT02853123|147642393|SUPERIORITY||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.134|0.267|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.267|0.134|<.0001
74045318|NCT02853123|147642394|SUPERIORITY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.096||0.2645|TWO_SIDED|95.0|-0.3|0.083|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|1 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.083|-0.300|0.2645
74045319|NCT02853123|147642394|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.107||0.0267|TWO_SIDED|95.0|-0.452|-0.028|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.028|-0.452|0.0267
74045320|NCT02853123|147642394|SUPERIORITY||Mean Difference (Final Values)|-0.318|STANDARD_ERROR_OF_MEAN|0.14||0.0258|TWO_SIDED|95.0|-0.596|-0.039|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2.5 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.039|-0.596|0.0258
74045321|NCT02853123|147642395|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.12||0.8025|TWO_SIDED|95.0|-0.268|0.208|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.208|-0.268|0.8025
74095607|NCT01791153|147740897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30mg/day, \>30mg/day).||||0.0003
74095608|NCT01791153|147740897|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
74016148|NCT01926782|147583818|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|||<|0.0001|TWO_SIDED|97.5|-38.9|-31.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.1|-38.9|<0.0001
74016149|NCT01926782|147583819|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.1|||<|0.0001|TWO_SIDED|97.5|-49.0|-39.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.2|-49.0|<0.0001
74045322|NCT02853123|147642396|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.099||0.3634|TWO_SIDED|95.0|-0.106|0.286|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.286|-0.106|0.3634
74095609|NCT01791153|147740898|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|0.61||||0.8067|TWO_SIDED|99.0|-5.86|7.07|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||7.07|-5.86|0.8067
74095610|NCT01791153|147740898|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.44||||0.0252|TWO_SIDED|99.0|-0.69|9.56|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.56|-0.69|0.0252
74095611|NCT01791153|147740898|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-0.56||||0.8374|TWO_SIDED|99.0|-7.64|6.53|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||6.53|-7.64|0.8374
74095612|NCT01791153|147740898|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|3.27||||0.1468|TWO_SIDED|99.0|-2.59|9.14|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.14|-2.59|0.1468
74095613|NCT01791153|147740898|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.38||||0.057|TWO_SIDED|99.0|-1.58|10.34|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||10.34|-1.58|0.0570
74095614|NCT01791153|147740898|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|5.59||||0.0024|TWO_SIDED|99.0|0.86|10.32|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||10.32|0.86|0.0024
74095615|NCT01791153|147740898|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|3.04||||0.2218|TWO_SIDED|99.0|-3.43|9.51|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.51|-3.43|0.2218
73880295|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.33||||0.0196|TWO_SIDED|95.0|1.27|14.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.82|1.27|0.0196
74016150|NCT01926782|147583820|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.8|||<|0.0001|TWO_SIDED|97.5|-49.7|-39.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.9|-49.7|<0.0001
74045323|NCT00106249|147642397|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73880296|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0433|TWO_SIDED|95.0|1.03|9.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.24|1.03|0.0433
74045324|NCT00106249|147642398|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74045325|NCT01665872|147642446|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.172|||||||t-test, 2 sided|||||||0.172
74016151|NCT01926782|147583821|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.5|||<|0.0001|TWO_SIDED|97.5|-54.5|-44.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.6|-54.5|<0.0001
74016152|NCT01926782|147583822|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.1|||<|0.0001|TWO_SIDED|97.5|-52.2|-42.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.0|-52.2|<0.0001
74016153|NCT01926782|147583823|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.4|||<|0.0001|TWO_SIDED|97.5|-40.4|-32.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.4|-40.4|<0.0001
74016154|NCT01926782|147583824|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.8|||<|0.0001|TWO_SIDED|97.5|-36.5|-29.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.1|-36.5|<0.0001
74016155|NCT01926782|147583825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|68.0|||<|0.0001|TWO_SIDED|97.5|20.9|221.0||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||221.0|20.9|<0.0001
74016156|NCT01926782|147583826|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.6|||<|0.0001|TWO_SIDED|97.5|13.7|47.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||47.8|13.7|<0.0001
74016157|NCT01926782|147583827|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|280.2|||<|0.0001|TWO_SIDED|97.5|56.7|1385.7||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1385.7|56.7|<0.0001
74016158|NCT01926782|147583828|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|41.3|||<|0.0001|TWO_SIDED|97.5|20.3|83.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model||83.8|20.3|<0.0001
74016159|NCT01926782|147583829|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|90.6|||<|0.0001|TWO_SIDED|97.5|16.5|498.3||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||498.3|16.5|<0.0001
74045326|NCT01665872|147642447|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.5337|||||||Wilcoxon (Mann-Whitney)|||Are CES-D scores at 12 months different between groups?||||0.5337
74045327|NCT01665872|147642448|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.092||||||This test looks at a difference in Parental Distress at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0920
74016160|NCT01926782|147583830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.5|||<|0.0001|TWO_SIDED|97.5|23.4|104.4||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||104.4|23.4|<0.0001
74016161|NCT01926782|147583831|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|297.1|||<|0.0001|TWO_SIDED|97.5|27.9|3160.6||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||3160.6|27.9|<0.0001
74016162|NCT01926782|147583832|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|77.7|||<|0.0001|TWO_SIDED|97.5|34.1|176.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||176.8|34.1|<0.0001
74045328|NCT01665872|147642448|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.3352||||||This test looks at a difference in Parent-Child Dysfunctional Interaction at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.3352
74045329|NCT01665872|147642448|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0404||||||This test looks at a difference in Difficult Child at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0404
73888051|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.3457|TWO_SIDED|95.0|-2.4|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.7|-2.4|0.3457
74045330|NCT01665872|147642448|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0915||||||This test looks at a difference in PSI total score (percentile) at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0915
74045331|NCT01665872|147642449|EQUIVALENCE|Chi-square was used with a p-value of 0.05 to determine if the difference was statistically greater than 0.||||||0.2914|||||||Chi-squared|||||||0.2914
74045332|NCT01929018|147642451|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.87
74045333|NCT01929018|147642451|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.38
74095616|NCT01791153|147740898|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.25||||0.0412|TWO_SIDED|99.0|-1.14|9.64|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.64|-1.14|0.0412
74095617|NCT01791153|147740899|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-15.6||||0.0312|TWO_SIDED|99.0|-34.3|3.1|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||3.1|-34.3|0.0312
74095618|NCT01791153|147740899|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-11.8||||0.0476|TWO_SIDED|99.0|-27.2|3.6|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||3.6|-27.2|0.0476
74095619|NCT01791153|147740899|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-21.9||||0.0059|TWO_SIDED|99.0|-42.4|-1.4|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||-1.4|-42.4|0.0059
74095620|NCT01791153|147740899|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-18.2||||0.0081|TWO_SIDED|99.0|-35.8|-0.5|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||-0.5|-35.8|0.0081
74095621|NCT00975286|147740909|SUPERIORITY_OR_OTHER||[Least squares (LS) mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED|95.0|-0.463|-0.171||Statistical testing: 2-sided at significance level=0.05. Analysis of covariance (ANCOVA) included treatment arms; randomization strata of Week -1 HbA1c (\<8.0,\>=8.0%) and TZD use (yes/no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 225 patients in each arm would provide a power of 98% (or 90%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.171|-0.463|<0.0001
74095622|NCT04156620|147740927|SUPERIORITY||Marginal difference|17.91|||<|0.0001|TWO_SIDED|95.0|10.12|25.71|||Regression, Logistic|||Week 16||25.71|10.12|<0.0001
74095623|NCT04156620|147740928|SUPERIORITY||Marginal difference|20.45|||<|0.0001|TWO_SIDED|95.0|14.45|26.44|||Regression, Logistic|||||26.44|14.45|<0.0001
74095624|NCT04156620|147740929|SUPERIORITY||LS mean change|-1.01|STANDARD_ERROR_OF_MEAN|0.189|<|0.0001|TWO_SIDED|95.0|-1.38|-0.64|||Mixed Models Analysis|||Week 16||-0.64|-1.38|<0.0001
74016163|NCT01926782|147583833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.7|||<|0.0001|TWO_SIDED|97.5|-37.0|-18.3||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-18.3|-37.0|<0.0001
74095625|NCT04156620|147740930|SUPERIORITY||Marginal difference|22.15|||<|0.0001|TWO_SIDED|95.0|14.36|29.95|||Regression, Logistic|||||29.95|14.36|<0.0001
74095626|NCT04156620|147740931|SUPERIORITY||LS mean change|-0.94|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|-1.33|-0.56|||Mixed Models Analysis|||Week 16||-0.56|-1.33|<0.0001
74095627|NCT04156620|147740932|SUPERIORITY||LS mean change|3.01|STANDARD_ERROR_OF_MEAN|0.615|<|0.0001|TWO_SIDED|95.0|1.8|4.22|||Mixed Models Analysis|||Week 16||4.22|1.80|<0.0001
74095628|NCT04156620|147740933|SUPERIORITY||LS mean change|-1.77|STANDARD_ERROR_OF_MEAN|0.373|<|0.0001|TWO_SIDED|95.0|-2.51|-1.04|||Mixed Models Analysis|||Week 16||-1.04|-2.51|<0.0001
74095629|NCT04156620|147740934|SUPERIORITY||Relative LS mean change|0.44|||<|0.0001|TWO_SIDED|95.0|0.37|0.51|||Mixed Models Analysis|||Week 16||0.51|0.37|<0.0001
74016164|NCT01926782|147583834|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.1|||<|0.0001|TWO_SIDED|97.5|-35.5|-22.7||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-22.7|-35.5|<0.0001
74016165|NCT01926782|147583835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.5|||<|0.0001|TWO_SIDED|97.5|-32.4|-14.5||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-14.5|-32.4|<0.0001
74016166|NCT01926782|147583836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-26.6|||<|0.0001|TWO_SIDED|97.5|-32.8|-20.4||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-20.4|-32.8|<0.0001
74095630|NCT04156620|147740935|SUPERIORITY||Marginal difference|23.41|||<|0.0001|TWO_SIDED|95.0|15.61|31.66|||Regression, Logistic|||||31.66|15.61|<0.0001
74095631|NCT04156620|147740936|SUPERIORITY||Marginal difference|12.58|||<|0.0001|TWO_SIDED|95.0|7.96|17.19|||Regression, Logistic|||Week 16||17.19|7.96|<0.0001
74095632|NCT04156620|147740937|SUPERIORITY||Marginal difference|10.56|||<|0.0001|TWO_SIDED|95.0|5.64|15.47|||Regression, Logistic|||||15.47|5.64|<0.0001
74095633|NCT04156620|147740938|SUPERIORITY||LS mean change|-0.66|STANDARD_ERROR_OF_MEAN|0.292||0.0234|TWO_SIDED|95.0|-1.24|-0.09|||Regression, Logistic|||||-0.09|-1.24|0.0234
74095634|NCT01753336|147740945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0|STANDARD_DEVIATION|8.94|||TWO_SIDED|95.0|-9.79|-6.28||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 is presented.||-6.28|-9.79|
74095635|NCT01753336|147740945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|STANDARD_DEVIATION|11.68|||TWO_SIDED|95.0|-7.36|-2.68||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 is presented.||-2.68|-7.36|
74095636|NCT01753336|147740945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9|STANDARD_DEVIATION|7.29|||TWO_SIDED|95.0|-7.42|-4.47||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 is presented.||-4.47|-7.42|
74095637|NCT01753336|147740945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|7.49|||TWO_SIDED|95.0|-3.37|-0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 is presented.||-0.27|-3.37|
74095638|NCT01753336|147740945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_DEVIATION|9.03|||TWO_SIDED|95.0|-5.99|-2.2||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||-2.20|-5.99|
74016167|NCT01926782|147583837|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.0003|TWO_SIDED|97.5|3.1|12.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.6|3.1|0.0003
74016168|NCT01926782|147583838|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1||||0.0004|TWO_SIDED|97.5|1.9|8.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.4|1.9|0.0004
74016169|NCT01926782|147583839|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.0004|TWO_SIDED|97.5|2.6|11.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)||11.1|2.6|0.0004
74045334|NCT01929018|147642452|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.75
74045335|NCT01929018|147642452|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.11
74045336|NCT01929018|147642453|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.11
74045337|NCT01929018|147642453|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.23
74045338|NCT01929018|147642454|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.27
74045339|NCT01929018|147642454|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.58
74045340|NCT01929018|147642455|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.83
74045341|NCT01929018|147642455|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.13
74095639|NCT01753336|147740945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_DEVIATION|9.42|||TWO_SIDED|95.0|-3.11|0.81||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.81|-3.11|
74095640|NCT01753336|147740946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|STANDARD_DEVIATION|9.74|||TWO_SIDED|95.0|-13.38|-9.56||||||Pretreatment baseline vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 1 is presented.||-9.56|-13.38|
74095641|NCT01753336|147740946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9|STANDARD_DEVIATION|10.89|||TWO_SIDED|95.0|-11.08|-6.71||||||Pretreatment baseline vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for treatment Cycle 1 is presented.||-6.71|-11.08|
74095642|NCT01753336|147740946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.4|STANDARD_DEVIATION|11.43|||TWO_SIDED|95.0|-16.74|-12.11||||||Pretreatment baseline vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 2 is presented.||-12.11|-16.74|
74045342|NCT01929018|147642456|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.03
74045343|NCT01929018|147642456|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.02
74045344|NCT01929018|147642457|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.03
74045345|NCT01929018|147642457|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.06
74045346|NCT01929018|147642458|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.62
74045347|NCT01929018|147642458|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.40
74045348|NCT01929018|147642459|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.96
74045349|NCT01929018|147642459|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.35
74045350|NCT04882072|147642460|SUPERIORITY||Hazard Ratio (HR)|1.86|||||TWO_SIDED|95.0|0.41|8.47||||||||8.47|0.41|
74095643|NCT01753336|147740946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.6|STANDARD_DEVIATION|11.33|||TWO_SIDED|95.0|-12.92|-8.22||||||Pretreatment baseline vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 2 is presented.||-8.22|-12.92|
74095644|NCT01753336|147740946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.6|STANDARD_DEVIATION|12.19|||TWO_SIDED|95.0|-17.18|-12.1||||||Pretreatment baseline vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 3 is presented.||-12.10|-17.18|
74095645|NCT01753336|147740946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.7|STANDARD_DEVIATION|11.17|||TWO_SIDED|95.0|-14.02|-9.39||||||Pretreatment baseline vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 3 is presented.||-9.39|-14.02|
74095646|NCT01753336|147740948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_DEVIATION|4.95|||TWO_SIDED|95.0|-4.46|-2.52||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-2.52|-4.46|
74095647|NCT01753336|147740948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|5.24|||TWO_SIDED|95.0|-2.81|-0.7||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.70|-2.81|
74095648|NCT01753336|147740948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.77|||TWO_SIDED|95.0|-3.75|-2.23||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-2.23|-3.75|
74095649|NCT01753336|147740948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.86|||TWO_SIDED|95.0|-1.33|0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||0.27|-1.33|
74095650|NCT01753336|147740948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_DEVIATION|4.32|||TWO_SIDED|95.0|-3.64|-1.83||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||-1.83|-3.64|
74095651|NCT01753336|147740948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|4.77|||TWO_SIDED|95.0|-2.0|-0.02||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||-0.02|-2.00|
74016170|NCT01926782|147583840|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.0007|TWO_SIDED|97.5|1.8|8.7||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.7|1.8|0.0007
74016171|NCT01926782|147583841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.9||||0.0042|TWO_SIDED|97.5|-21.3|-2.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-2.6|-21.3|0.0042
74016172|NCT01926782|147583842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.1|||<|0.0001|TWO_SIDED|97.5|-21.5|-8.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-8.6|-21.5|<0.0001
74016173|NCT01926782|147583843|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.1||||0.0004|TWO_SIDED|97.5|-22.9|-5.2||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-5.2|-22.9|0.0004
74045351|NCT03097133|147642481|SUPERIORITY||Difference of Least Square Means|-3.9|STANDARD_ERROR_OF_MEAN|1.39||0.006|TWO_SIDED|95.0|-6.6|-1.11|||ANCOVA|||||-1.11|-6.60|0.006
74045352|NCT00356057|147642529|SUPERIORITY|||||||0.437|||||||t-test, 2 sided|||||||0.437
74045353|NCT00356057|147642529|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
74045354|NCT00356057|147642530|EQUIVALENCE|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0596|||||||t-test, 1 sided|||||||0.0596
74045355|NCT00356057|147642531|EQUIVALENCE|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0009|||||||t-test, 1 sided|||||||0.0009
74045356|NCT00356057|147642534|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.030
74045357|NCT00356057|147642534|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
74045358|NCT00356057|147642538|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
74045359|NCT00356057|147642538|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
74045360|NCT00356057|147642539|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
74045361|NCT00356057|147642539|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
74045362|NCT00356057|147642540|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74045363|NCT00356057|147642540|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
74045364|NCT00356057|147642541|SUPERIORITY|||||||0.039|||||||t-test, 2 sided|||||||0.039
74045365|NCT00356057|147642541|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
74045366|NCT01000818|147642542|NON_INFERIORITY_OR_EQUIVALENCE|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.39||||||95.0|1.04|1.84||||||||1.84|1.04|
74016174|NCT01926782|147583844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.6|||<|0.0001|TWO_SIDED|97.5|-20.3|-6.9||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-6.9|-20.3|<0.0001
74016175|NCT01926782|147583845|SUPERIORITY_OR_OTHER||LS Mean Difference|6.6|||<|0.0001|TWO_SIDED|97.5|3.0|10.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.2|3.0|<0.0001
74016176|NCT01926782|147583846|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0306|TWO_SIDED|97.5|-0.1|5.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis||Alirocumab 300 mg vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.4|-0.1|0.0306
74016177|NCT00430508|147583896|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.3|||<|0.0001||95.0|-6.97|-3.6|||ANCOVA|||||-3.6|-6.97|<0.0001
74016178|NCT00430508|147583896|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4|||<|0.0001||95.0|-4.79|-2.03|||ANCOVA|||||-2.03|-4.79|<0.0001
74016179|NCT00430508|147583896|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.1788||95.0|-2.32|0.43|||ANCOVA|||||0.43|-2.32|0.1788
74016180|NCT00430508|147583897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|||<|0.0001||95.0|-5.54|-2.6|||ANCOVA|||||-2.6|-5.54|<0.0001
74045367|NCT01000818|147642542|NON_INFERIORITY_OR_EQUIVALENCE|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.45||||||95.0|1.09|1.93||||||||1.93|1.09|
74045368|NCT02427100|147642549|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANCOVA|||||||.18
74095652|NCT01753336|147740949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_DEVIATION|3.86|||TWO_SIDED|95.0|-3.64|-2.12||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-2.12|-3.64|
74095653|NCT01753336|147740949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|4.82|||TWO_SIDED|95.0|-2.79|-0.86||||||Cycle 1-Day 1 vs Cycle 1-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.86|-2.79|
74095654|NCT01753336|147740949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|3.47|||TWO_SIDED|95.0|-2.44|-1.04||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-1.04|-2.44|
74016181|NCT00430508|147583897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.39|-1.98|||ANCOVA|||||-1.98|-4.39|<0.0001
74016182|NCT00430508|147583897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1081||95.0|-2.19|0.22|||ANCOVA|||||0.22|-2.19|0.1081
74016183|NCT00430508|147583898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.4|||<|0.0001||95.0|-10.13|-4.66|||ANCOVA|||||-4.66|-10.13|<0.0001
74045369|NCT02427100|147642550|SUPERIORITY_OR_OTHER|||||||0.00036||||||The Linear Mixed Model (LMM) regression analysis (repeated measures) was adjusted for daily minutes of accelerometer wear time, gender, age, BMI, education, and meeting physical activity guidelines at baseline.|Mixed Models Analysis|A fourth root transformation of daily accelerometer-measured minutes of MVPA was used to normalize the distribution and was included in the analyses.||||||.00036
74045370|NCT02120352|147642551|OTHER||Difference in Percentage|3.7|||||TWO_SIDED|95.0|-4.8|12.2|||||Comparison between CAB LA 600 mg+RPV LA 900 mg IM-Q8W and CAB 30 mg+ABC/3TC QD|||12.2|-4.8|
74045371|NCT02120352|147642551|OTHER||Difference in Percentage|2.8|||||TWO_SIDED|95.0|-5.8|11.5|||||Comparison between CAB LA 400 mg+RPV LA 600 mg IM-Q4W and CAB 30 mg+ABC/3TC QD|||11.5|-5.8|
74045372|NCT00444964|147642616|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74016184|NCT00430508|147583898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2|||<|0.0001||95.0|-7.4|-2.91|||ANCOVA|||||-2.91|-7.4|<0.0001
74016185|NCT00430508|147583898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.0255||95.0|-4.79|-0.31|||ANCOVA|||||-0.31|-4.79|0.0255
74016186|NCT00430508|147583899|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.6|||<|0.0001||95.0|-9.0|-4.26|||ANCOVA|||||-4.26|-9.00|<0.0001
74016187|NCT00430508|147583899|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|||<|0.0001||95.0|-6.7|-2.81|||ANCOVA|||||-2.81|-6.70|<0.0001
74016188|NCT00430508|147583899|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.0812||95.0|-3.66|0.21|||ANCOVA|||||0.21|-3.66|0.0812
74016189|NCT00430508|147583900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67||||||95.0|1.69|4.21|||Regression, Logistic|||||4.21|1.69|
74016190|NCT00430508|147583900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||||95.0|1.5|3.24|||Regression, Logistic|||||3.24|1.50|
74016191|NCT00430508|147583900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||||95.0|1.07|2.25|||Regression, Logistic|||||2.25|1.07|
74045373|NCT00444964|147642617|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74045374|NCT00444964|147642618|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74045375|NCT02573233|147642631|SUPERIORITY|||||||0.84||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.8400
74016192|NCT00430508|147583901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|||<|0.0001||95.0|-6.78|-3.36|||ANCOVA|||||-3.36|-6.78|<0.0001
74016193|NCT00430508|147583901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.54|-1.78|||ANCOVA|||||-1.78|-4.54|<0.0001
74016194|NCT00430508|147583901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1452||95.0|-2.43|0.36|||ANCOVA|||||0.36|-2.43|0.1452
74016195|NCT00430508|147583902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|||<|0.0001||95.0|-6.79|-3.17|||ANCOVA|||||-3.17|-6.79|<0.0001
74016196|NCT00430508|147583902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3|||<|0.0001||95.0|-4.79|-1.87|||ANCOVA|||||-1.87|-4.79|<0.0001
74016197|NCT00430508|147583902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1629||95.0|-2.52|0.42|||ANCOVA|||||0.42|-2.52|0.1629
74016198|NCT00430508|147583903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.5|||<|0.0001||95.0|-7.4|-3.62|||ANCOVA|||||-3.62|-7.40|<0.0001
74045376|NCT02573233|147642632|SUPERIORITY||LS Mean Difference|-235.02||||0.0336|TWO_SIDED|90.0|-414.19|-55.84||Threshold for significance at 0.05 level|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||-55.84|-414.19|0.0336
74045377|NCT02573233|147642633|SUPERIORITY||LS mean difference|13.89||||0.4795|TWO_SIDED|90.0|-19.0|46.78||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||46.78|-19.00|0.4795
74095655|NCT01753336|147740949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|3.46|||TWO_SIDED|95.0|-1.55|-0.12||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||-0.12|-1.55|
74016199|NCT00430508|147583903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|||<|0.0009||95.0|-4.12|-1.07|||ANCOVA|||||-1.07|-4.12|<0.0009
74016200|NCT00430508|147583903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1985||95.0|-2.55|0.53|||ANCOVA|||||0.53|-2.55|0.1985
74016201|NCT03138876|147583909|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
74016202|NCT01707693|147583913|SUPERIORITY|repeated measures mixed model analysis of covariance, with the baseline measurement as a covariate.||||||0.023||||||P-value calculated from repeated measures model adjusting for age with a log transformation applied. P-values are one-sided.|ANCOVA|||||||0.023
74016203|NCT01707693|147583914|SUPERIORITY|||||||0.011||||||\* P-value calculated from repeated measures model adjusting for age with a log transformation applied.|ANCOVA|\* P-value calculated from repeated measures model adjusting for age with a log transformation applied.||||||0.011
74016204|NCT01707693|147583915|OTHER|2-sided Wilcoxon Rank Sum test||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
74016205|NCT01707693|147583916|OTHER|counts of stage of change||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Armitage trend test||||||.001
74016206|NCT03987854|147583917|SUPERIORITY||paired t-test|-7.67|STANDARD_DEVIATION|6.1|<|0.001|TWO_SIDED|||||-6.16|t-test, 2 sided|||||||<.001
74016207|NCT03987854|147583918|SUPERIORITY||paired t-test|-0.21|STANDARD_DEVIATION|0.27||0.001|TWO_SIDED|||||-3.29|t-test, 2 sided|||||||.001
74016208|NCT03987854|147583919|SUPERIORITY||paired t-test|1.92|STANDARD_DEVIATION|1.17|<|0.001|TWO_SIDED|||||7.52|t-test, 2 sided|||||||<.001
74016209|NCT03987854|147583920|SUPERIORITY||paired t-test|1.14|STANDARD_DEVIATION|1.04|<|0.001|TWO_SIDED|||||5.03|t-test, 2 sided|||||||<.001
74016210|NCT03987854|147583921|SUPERIORITY||paired t-test|2.52|STANDARD_DEVIATION|1.7|<|0.001|TWO_SIDED|||||6.81|t-test, 2 sided|||||||<.001
74016211|NCT03987854|147583922|SUPERIORITY||paired t-test|1.08|STANDARD_DEVIATION|1.43||0.003|TWO_SIDED|||||3.46|t-test, 2 sided|||||||.003
74016212|NCT03987854|147583923|SUPERIORITY||paired t-test|1.11|STANDARD_DEVIATION|1.56||0.004|TWO_SIDED|||||3.26|t-test, 2 sided|||||||.004
74016213|NCT03987854|147583924|SUPERIORITY||paired t-test|2.1|STANDARD_DEVIATION|2.76||0.002|TWO_SIDED|||||3.49|t-test, 2 sided|||||||.002
74016214|NCT04673786|147583925|EQUIVALENCE|Predefined equivalence margin: -10% to 10%|Treatment difference (%) and 90% CI|2.05|||||TWO_SIDED|90.0|-0.23|4.32|||ANCOVA|Multiple imputation (MI) with the Missing at random (MAR) assumption was applied.||||4.32|-0.23|
74016215|NCT02171611|147583942|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|175.14|STANDARD_ERROR_OF_MEAN|50.7|||TWO_SIDED|90.0|141.904|216.149|||||Relative bioavailability was estimated by the ratio of the gMeans of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||216.149|141.904|
74016216|NCT02171611|147583942|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|154.84|STANDARD_ERROR_OF_MEAN|46.6|||TWO_SIDED|90.0|127.425|188.161|||||Relative bioavailability was estimated by the ratio of the geometric means (gMeans) of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment (T2) vs. the Reference treatment (R). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||188.161|127.425|
74016217|NCT02171611|147583943|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|175.4|STANDARD_ERROR_OF_MEAN|51.1|||TWO_SIDED|90.0|141.924|216.772|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||216.772|141.924|
74016218|NCT02171611|147583943|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|158.12|STANDARD_ERROR_OF_MEAN|46.7|||TWO_SIDED|90.0|130.052|192.255|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||192.255|130.052|
74045378|NCT02573233|147642634|SUPERIORITY||LS mean difference|-18.98||||0.4494|TWO_SIDED|90.0|-60.92|22.97||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||22.97|-60.92|0.4494
74045379|NCT02573233|147642635|SUPERIORITY|||||||0.6865||||||Threshold for significance at 0.05 level.|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.6865
74016219|NCT02171611|147583944|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|186.94|STANDARD_ERROR_OF_MEAN|57.7|||TWO_SIDED|90.0|147.659|236.665|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||236.665|147.659|
74016220|NCT02171611|147583944|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|166.59|STANDARD_ERROR_OF_MEAN|54.3|||TWO_SIDED|90.0|133.221|208.326|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||208.326|133.221|
74016221|NCT02171611|147583945|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|181.6|STANDARD_ERROR_OF_MEAN|53.9|||TWO_SIDED|90.0|145.428|226.776|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||226.776|145.428|
74016222|NCT02171611|147583945|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|166.83|STANDARD_ERROR_OF_MEAN|52.6|||TWO_SIDED|90.0|134.25|207.328|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||207.328|134.25|
74016223|NCT02171611|147583946|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|182.17|STANDARD_ERROR_OF_MEAN|56.1|||TWO_SIDED|90.0|144.727|229.297|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||229.297|144.727|
74016224|NCT02171611|147583946|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|160.74|STANDARD_ERROR_OF_MEAN|52.0|||TWO_SIDED|90.0|129.633|199.306|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||199.306|129.633|
74016225|NCT02171611|147583947|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|182.25|STANDARD_ERROR_OF_MEAN|55.7|||TWO_SIDED|90.0|144.993|229.075|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||229.075|144.993|
74016226|NCT02171611|147583947|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|164.01|STANDARD_ERROR_OF_MEAN|51.7|||TWO_SIDED|90.0|132.421|203.14|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||203.14|132.421|
74016227|NCT02573155|147583983|SUPERIORITY_OR_OTHER||Least Square Mean|0.111|STANDARD_ERROR_OF_MEAN|0.0265|<|0.0001|TWO_SIDED|95.0|0.0585|0.163|||ANCOVA|||||0.163|0.0585|<0.0001
74016228|NCT02573155|147583983|SUPERIORITY_OR_OTHER||Least square mean|0.21|STANDARD_ERROR_OF_MEAN|0.0272|<|0.0001||95.0|0.156|0.264|||ANCOVA|||||0.264|0.156|<0.0001
74016229|NCT02189850|147583995|SUPERIORITY|||||||0.923|||||||Cochran-Mantel-Haenszel|||||||0.923
74016230|NCT00802685|147584018|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0|STANDARD_DEVIATION|8.0||0.858|TWO_SIDED|95.0|4.0|36.0|||Wilcoxon (Mann-Whitney)|||Null hypothesis: Oxygen duration (days) during the first 28 days will be equal between treatment arms.||36|4|0.858
74016231|NCT00802685|147584019|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.953||||0.8|TWO_SIDED|95.0|0.393|2.309|||Cochran-Mantel-Haenszel|||null hypothesis: The proportion of subjects on O2 at 36 wk PMA will be equal between treatment arms.||2.309|0.393|0.8
74045380|NCT02573233|147642636|SUPERIORITY|||||||0.7588||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.7588
74045381|NCT02573233|147642637|SUPERIORITY||LS Mean Difference|-22.4||||0.0012|TWO_SIDED|90.0|-32.9|-11.9||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect Model with Repeated Measures (MRMM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.||-11.9|-32.9|0.0012
73880297|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0355|TWO_SIDED|95.0|1.08|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.20|1.08|0.0355
74016232|NCT06142643|147584025|OTHER|"A responder was defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.~Inferential analysis for the primary evaluation criterion For the derived outcome responder rate at M1 (1 month after injection) for the GAIS Investigator, a binomial exact test (bilateral approach) vs 60% was applied for the overall score. This test compared the proportion of improvement to 60%."|||||<|0.0001||||||Power of 80%, significant result (alpha = 5%).|t-test, 2 sided|Null hypothesis stated that less than 60% of subjects were responders with GAIS. Under the alternative hypothesis, 75% of subjects were responders.||||||<0.0001
74016233|NCT06142643|147584026|OTHER|"A responder was defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.~Inferential analysis for the primary evaluation criterion For the derived outcome responder rate at M1 (1 month after injection) for the GAIS Investigator, a binomial exact test (bilateral approach) vs 60% was applied for the overall score. This test compared the proportion of improvement to 60%."|||||<|0.0001||||||Power of 80%, significant result (alpha = 5%).|t-test, 2 sided|Null hypothesis stated that less than 60% of subjects were responders with GAIS. Under the alternative hypothesis, 75% of subjects were responders.||||||<0.0001
74045382|NCT02573233|147642638|SUPERIORITY||LS Mean Difference|-22.0||||0.0005|TWO_SIDED|90.0|-31.3|-12.8||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect model with Repeated Measures (MMRM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.||-12.8|-31.3|0.0005
74045383|NCT02023112|147642657|SUPERIORITY_OR_OTHER_LEGACY||percentage of participants with SVR12|91.5|||||TWO_SIDED|95.0|80.1|96.6|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 16-week treatment arm to a clinically relevant threshold.~Lower bound of 95% confidence interval (LCB) must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-interferon (IFN) alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."||96.6|80.1|
74045384|NCT02023112|147642657|SUPERIORITY_OR_OTHER_LEGACY||percentage of participants with SVR12|75.0|||||TWO_SIDED|95.0|61.2|85.1|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 12-week treatment arm to a clinically relevant threshold.~LCB must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-IFN alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."||85.1|61.2|
74045385|NCT03536923|147642669|OTHER|||||||0.0001|||||||t-test, 1 sided|||||||0.0001
74045386|NCT03536923|147642670|OTHER|||||||0.0009|||||||t-test, 1 sided|||||||0.0009
74045387|NCT03536923|147642672|OTHER|||||||0.0001|||||||t-test, 1 sided|||||||0.0001
74045388|NCT02228824|147642676|SUPERIORITY||Mean Difference (Final Values)|1.51|||<|0.001|TWO_SIDED|95.0|0.86|2.17|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE||||2.17|0.86|<0.001
74045389|NCT02228824|147642678|SUPERIORITY||Mean Difference (Final Values)|-38.5||||0.041|TWO_SIDED|95.0|-75.21|-1.78|||Mixed Models Analysis|||||-1.78|-75.21|0.041
74045390|NCT02228824|147642679|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.016|TWO_SIDED|95.0|-1.26|-0.13|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE||||-0.13|-1.26|0.016
74045391|NCT02228824|147642680|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.03|TWO_SIDED|95.0|-0.04|-0.002|||Mixed Models Analysis|||||-0.002|-0.04|0.03
74045392|NCT01042938|147642737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7991|STANDARD_DEVIATION|0.7606||0.0077|TWO_SIDED|95.0|-1.3693|-0.2289|||Standard pooled variances t-test|||Hypothesis: The mean RDS for curcumin group is significantly different (i.e., lower) than mean RDS of placebo group at end of radiation treatment.||-0.2289|-1.3693|0.0077
74045393|NCT01042938|147642738|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Fisher Exact|||Hypothesis: The presence of moist desquamation significantly differed between the curcumin group and the placebo group.||||0.0022
74045394|NCT01042938|147642739|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||ANOVA|||Hypothesis: There is a significant difference in mean redness (i.e., mean a\* number value) between the curcumin and placebo groups.||||0.145
74045395|NCT01042938|147642740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.685||||0.218|TWO_SIDED|95.0|-1.059|4.428|||ANCOVA|||Hypothesis: There is a significant difference in mean MPQ pain scores between the curcumin and placebo groups.||4.428|-1.059|0.218
74045396|NCT01042938|147642740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.152|TWO_SIDED|95.0|-0.6|3.6|||ANCOVA|||Hypothesis: There is a significant difference in mean sensory subscale pain scores between curcumin and placebo groups.||3.6|-0.6|0.152
74045397|NCT01042938|147642740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7|TWO_SIDED|95.0|-0.7|1.1|||ANCOVA|||Hypohesis: There is a signifcant difference in affective subscale pain scores between curcumin and placebo groups.||1.1|-0.7|0.700
74045398|NCT01042938|147642740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.559|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Hypothesis: There is a significant difference in mean perceived pain scores between curcumin and placebo groups.||0.7|-0.4|0.559
74095656|NCT01753336|147740949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|3.75|||TWO_SIDED|95.0|-1.45|0.12||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||0.12|-1.45|
73888052|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7||||0.6664|TWO_SIDED|95.0|-13.3|20.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.8|-13.3|0.6664
73880298|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3238|TWO_SIDED|95.0|0.62|4.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.28|0.62|0.3238
73880299|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.68||||0.3208|TWO_SIDED|95.0|0.6|4.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.68|0.60|0.3208
73880300|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2281|TWO_SIDED|95.0|0.67|5.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.40|0.67|0.2281
73880301|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0566|TWO_SIDED|95.0|0.97|10.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.46|0.97|0.0566
74016234|NCT03485820|147584034|SUPERIORITY||Mean Difference (Net)|1.3||||0.76|TWO_SIDED|95.0|-7.1|9.6||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||9.6|-7.1|0.76
74016235|NCT03485820|147584035|SUPERIORITY||Mean Difference (Net)|-1.8||||0.6|TWO_SIDED|95.0|-8.6|5.0||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||5.0|-8.6|0.60
74016236|NCT03485820|147584036|SUPERIORITY||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.06|0.05||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.05|-0.06|0.83
74016237|NCT03485820|147584037|SUPERIORITY||Mean Difference (Net)|0.39||||0.046|TWO_SIDED|95.0|0.01|0.77||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression , number of days in inpatient rehabilitation, and baseline calendar time.||0.77|0.01|0.046
74045399|NCT00856986|147642762|SUPERIORITY_OR_OTHER||Estimated Treatment Difference, LSMean|-0.52||||||95.0|-0.68|-0.36|||ANCOVA|||The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5% and with the power of 90%.||-0.36|-0.68|
74045400|NCT00856986|147642763|SUPERIORITY_OR_OTHER||Estimated Treatment Difference, LSMean|-0.41||||||95.0|-0.6|-0.21|||ANCOVA||The analysis values for intensified Lira 1.8 mg subjects were kept in the treatment group and the last observation carried forward (LOCF) method was applied.|The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5%.||-0.21|-0.6|
74045401|NCT00856986|147642764|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS mean|-0.51||||||95.0|-0.7|-0.31|||ANCOVA||The mean change in HbA1c from randomisation to week 52 was analysed including the values before intensification as LOCF for intensified subjects|||-0.31|-0.7|
74045402|NCT02043509|147642805|SUPERIORITY||Adjusted odds ratio|2.7|||||TWO_SIDED|95.0|0.93|9.35|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||9.35|0.93|
74045403|NCT02043509|147642806|SUPERIORITY||Adjusted odds ratio|1.03|||||TWO_SIDED|95.0|0.61|1.75|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||1.75|0.61|
74045404|NCT02043509|147642807|SUPERIORITY||Adjusted odds ratio|1.34|||||TWO_SIDED|95.0|0.79|2.31|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||2.31|0.79|
74045405|NCT02043509|147642808|SUPERIORITY||Adjusted odds ratio|1.67|||||TWO_SIDED|95.0|0.72|4.03|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||4.03|0.72|
74045406|NCT02043509|147642809|SUPERIORITY||Adjusted odds ratio|2.11|||||TWO_SIDED|95.0|0.89|5.46|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||5.46|0.89|
74045407|NCT02043509|147642810|SUPERIORITY||Adjusted odds ratio|3.16|||||TWO_SIDED|95.0|1.14|10.69|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||10.69|1.14|
74045408|NCT02043509|147642811|SUPERIORITY||Adjusted odds ratio|3.28|||||TWO_SIDED|95.0|0.9|17.36|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||17.36|0.90|
74045409|NCT02043509|147642812|SUPERIORITY|||||||0.118|||||||Mann-Whitney U-test|||||||0.118
73880302|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.39||||0.1491|TWO_SIDED|95.0|0.73|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.78|0.73|0.1491
74016238|NCT03485820|147584038|SUPERIORITY||Mean Difference (Net)|0.52||||0.02|TWO_SIDED|95.0|0.08|0.96||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.96|0.08|0.02
74016239|NCT03485820|147584039|SUPERIORITY||Mean Difference (Net)|-10.6||||0.07|TWO_SIDED|95.0|-21.9|0.8||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.8|-21.9|0.07
74016240|NCT04685876|147584040|SUPERIORITY|||||||0.355|||||||Regression, Linear|||||||0.355
74016241|NCT04685876|147584040|SUPERIORITY|||||||0.578|||||||Regression, Linear|||||||0.578
74016242|NCT04685876|147584042|SUPERIORITY|||||||0.248|||||||Regression, Cox|||||||0.248
74016243|NCT04685876|147584042|SUPERIORITY|||||||0.297|||||||Regression, Cox|||||||0.297
74016244|NCT04685876|147584043|SUPERIORITY|||||||0.748|||||||Mixed Models Analysis|||||||0.748
74016245|NCT04685876|147584043|SUPERIORITY|||||||0.395|||||||Mixed Models Analysis|||||||0.395
74016246|NCT04685876|147584044|SUPERIORITY|||||||0.152|||||||Regression, Linear|||||||0.152
74045410|NCT03180294|147642869|SUPERIORITY|||||||0.46|||||||t-test, 1 sided|||Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..||||0.46
74045411|NCT03180294|147642869|SUPERIORITY|||||||0.54|||||||t-test, 1 sided|||Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..||||0.54
74045412|NCT03180294|147642870|SUPERIORITY|||||||0.95||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.95
74016247|NCT04685876|147584044|SUPERIORITY|||||||0.482|||||||Regression, Linear|||||||0.482
74045413|NCT03180294|147642870|SUPERIORITY|||||||0.73||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.73
74045414|NCT03180294|147642870|SUPERIORITY|||||||0.46||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.46
74045415|NCT03180294|147642870|SUPERIORITY|||||||0.42||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.42
73880303|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1477|TWO_SIDED|95.0|0.74|7.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.23|0.74|0.1477
74016248|NCT01358864|147584045|SUPERIORITY_OR_OTHER||Adjusted percent difference|52.8|||<|0.0001|TWO_SIDED|95.0|42.4|63.2||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||63.2|42.4|<0.0001
74016249|NCT01358864|147584045|SUPERIORITY_OR_OTHER||Adjusted percent difference|48.5|||<|0.0001|TWO_SIDED|95.0|38.2|58.9||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||58.9|38.2|<0.0001
74016250|NCT01358864|147584045|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.4|||||TWO_SIDED|95.0|-6.0|14.9||||||||14.9|-6.0|
74016251|NCT01358864|147584045|SUPERIORITY_OR_OTHER||Adjusted percent difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.7||||||||10.7|-10.9|
74016252|NCT01358864|147584045|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.||||<0.0001
74016253|NCT01358864|147584045|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.||||0.0001
74016254|NCT01358864|147584047|SUPERIORITY_OR_OTHER||Adjusted percent difference|54.7|||<|0.0001|TWO_SIDED|95.0|44.4|65.0||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||65.0|44.4|<0.0001
74045416|NCT03180294|147642871|SUPERIORITY|||||||0.24||||||One-side significance level 0.05|t-test, 1 sided|||||||0.24
73888053|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.1949|TWO_SIDED|95.0|-5.8|28.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.0|-5.8|0.1949
74016255|NCT01358864|147584047|SUPERIORITY_OR_OTHER||Adjusted percent difference|50.4|||<|0.0001|TWO_SIDED|95.0|40.1|60.8||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||60.8|40.1|<0.0001
74016256|NCT01358864|147584047|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.5|||||TWO_SIDED|95.0|-5.8|14.9||||||||14.9|-5.8|
74016257|NCT01358864|147584047|SUPERIORITY_OR_OTHER||Adjusted percent difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.7||||||||10.7|-10.9|
74016258|NCT01358864|147584047|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.||||<0.0001
74016259|NCT01358864|147584047|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.||||0.0001
74045417|NCT03180294|147642871|SUPERIORITY|||||||0.74||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.74
74045418|NCT03180294|147642872|SUPERIORITY|||||||0.41||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.41
74095657|NCT01753336|147740949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|3.73|||TWO_SIDED|95.0|-0.85|0.7||||||Cycle 3-Day 1 vs Cycle 3-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.70|-0.85|
74095658|NCT01753336|147740950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|3.74|||TWO_SIDED|95.0|-2.39|-0.92||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-0.92|-2.39|
74095659|NCT01753336|147740950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|3.88|||TWO_SIDED|95.0|-2.22|-0.66||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.66|-2.22|
74095660|NCT01753336|147740950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|3.12|||TWO_SIDED|95.0|-1.84|-0.58||||||Cycle 2-Day 1 vs Cycle 2-Week 4.The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-0.58|-1.84|
74095661|NCT01753336|147740950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.04|||TWO_SIDED|95.0|-1.08|0.18||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||0.18|-1.08|
74095662|NCT01753336|147740950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|4.2|||TWO_SIDED|95.0|-1.57|0.19||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||0.19|-1.57|
74095663|NCT01753336|147740950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|3.78|||TWO_SIDED|95.0|-0.85|0.73||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.73|-0.85|
74095664|NCT01629966|147740966|SUPERIORITY||Least Squares Mean Difference|-1.27||||0.083|TWO_SIDED|95.0|-2.71|0.17|||MMRM|||||0.17|-2.71|0.0830
74095665|NCT01629966|147740966|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.0156|TWO_SIDED|95.0|-3.26|-0.34|||MMRM|||||-0.34|-3.26|0.0156
74095666|NCT01629966|147740967|SUPERIORITY||Least Squares Mean Difference|-1.37||||0.0536|TWO_SIDED|95.0|-2.75|0.02|||MMRM|||||0.02|-2.75|0.0536
74095667|NCT01629966|147740967|SUPERIORITY||Least Squares Mean Difference|-1.52||||0.0349|TWO_SIDED|95.0|-2.94|-0.11|||MMRM|||||-0.11|-2.94|0.0349
74095668|NCT04568031|147740968|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
74095669|NCT04568031|147740968|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
74095670|NCT04568031|147740973|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
74016260|NCT03194373|147584056|SUPERIORITY|Power to detect a 20% improvement in disease control rate (DCR). Based on historical data, the DCR in R/M HNSCC with single agent platinum therapy is 40%. We hypothesize that addition of Palbociclib will increase DCR at 12 weeks to 60%. Two-stage design. Type I error rate of 0.059 and power of 0.80 when the true response rate is 0.60 with alpha=0.05. The two-stage sample size calculations assume a null probability of 0.40.|Proportion|33.0|||||TWO_SIDED|95.0|13.0|59.0||||||||59|13|
74095671|NCT04568031|147740973|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
74095672|NCT04568031|147740976|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
74016261|NCT03194373|147584057|OTHER||||||||||||||||||Median survival times were computed using the Kaplan-Meier method with standard error computed using Greenwood's formula. All analyses were done using SAS 9.4 software.|||
74095673|NCT04568031|147740976|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
74095674|NCT03801382|147740980|EQUIVALENCE|Validity and test-retest reliability were explored|Mean Difference (Final Values)|0.05|||>|0.05|TWO_SIDED||||||t-test, 2 sided||||Validity and test-retest reliability were explored|||>.05
74095675|NCT00786994|147740990|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Mantel Haenszel|||A vs C/D||||0.60
74095676|NCT00786994|147740990|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Mantel Haenszel|||B vs. C/D||||0.83
74095677|NCT03564444|147740991|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.7|1.9||||||||1.9|-6.7|
74095678|NCT03753763|147741001|SUPERIORITY||Least square mean difference|0.1||||0.9697|TWO_SIDED|95.0|-6.3|6.5|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in anterior and lateral displacement from baseline||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||6.5|-6.3|0.9697
74095679|NCT03753763|147741002|SUPERIORITY||least square mean difference|0.5||||0.7751|TWO_SIDED|95.0|-3.1|4.1||A mixed-model repeated measures (MMRM) was used to analyze the change in anterior and lateral displacement from baseline.|Mixed Models Analysis|||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate||4.1|-3.1|0.7751
74095680|NCT03753763|147741003|SUPERIORITY||least square mean difference|0.2||||0.9076|TWO_SIDED|95.0|-3.3|3.7|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in UMSARS Part II||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||3.7|-3.3|0.9076
74095681|NCT03753763|147741004|SUPERIORITY||least square mean difference|-1.1||||0.5386|TWO_SIDED|95.0|-4.8|2.6|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in UMSARS Part II.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||2.6|-4.8|0.5386
74095682|NCT03753763|147741005|SUPERIORITY||Least square mean difference|6.0||||0.3364|TWO_SIDED|95.0|-6.5|18.6|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in MSA-QoL scale.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||18.6|-6.5|0.3364
74045419|NCT03180294|147642872|SUPERIORITY|||||||0.6||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.60
74045420|NCT03180294|147642872|SUPERIORITY|||||||0.9||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.90
74095683|NCT03753763|147741006|SUPERIORITY||Least square mean difference|0.2||||0.7574|TWO_SIDED|95.0|-1.1|1.5|||ANCOVA|||The ANCOVA included change from baseline as the response variable, treatment group as a factor, and baseline score as a covariate||1.5|-1.1|0.7574
74016262|NCT03194373|147584058|OTHER||||||||||||||||||Median survival times were computed using the Kaplan-Meier method with standard error computed using Greenwood's formula. All analyses were done using SAS 9.4 software.|||
74016263|NCT02177201|147584060|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: The antiemetic effect was not significantly different for two groups in this study||||0.05
74016264|NCT02177201|147584060|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared, Corrected|||77 patients was needed in each groups for an 20% effect size, 5% alpha and 80% statistical power for postoperative vomiting.||||<0.05
74016265|NCT02926950|147584086|SUPERIORITY||Difference in Least Squares (LS) Means|-0.47|STANDARD_ERROR_OF_MEAN|0.084|<|0.0001|TWO_SIDED|95.0|-0.64|-0.309|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.309|-0.64|< 0.0001
74016266|NCT02926950|147584087|SUPERIORITY||Difference in LS Means|-1.572|STANDARD_ERROR_OF_MEAN|0.2457|<|0.0001|TWO_SIDED|95.0|-2.0538|-1.0909|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and country as fixed effects, and baseline 2- hour postprandial glucose as a covariate.||-1.0909|-2.0538|< 0.0001
74016267|NCT02926950|147584088|SUPERIORITY||Difference in LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.2247|=|0.0007|TWO_SIDED|95.0|-1.2006|-0.3198|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.3198|-1.2006|= 0.0007
74016268|NCT02926950|147584089|SUPERIORITY||Difference in LS Means|-1.87|STANDARD_ERROR_OF_MEAN|0.369|<|0.0001|TWO_SIDED|95.0|-2.591|-1.144|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and country as fixed effects, and baseline weight as a covariate.||-1.144|-2.591|< 0.0001
74016269|NCT02926950|147584090|SUPERIORITY||Difference in LS Means|-3.28|STANDARD_ERROR_OF_MEAN|1.422|=|0.0209|TWO_SIDED|95.0|-6.07|-0.497|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.0, \>8.0%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-0.497|-6.07|= 0.0209
74016270|NCT02926950|147584091|SUPERIORITY||Difference in LS Means|-3.54|STANDARD_ERROR_OF_MEAN|0.992|=|0.0004|TWO_SIDED|95.0|-5.479|-1.592|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.592|-5.479|= 0.0004
74016271|NCT02926950|147584092|SUPERIORITY||Percentage Difference|5.4|||=|0.0238|TWO_SIDED|95.0|0.75|10.06|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening. Missing data at Week 26 were assigned a status of nonresponder in the analysis.||10.06|0.75|= 0.0238
74016272|NCT02926950|147584093|SUPERIORITY||Percentage Difference|13.9|||=|0.0001|TWO_SIDED|95.0|6.91|20.89|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening. Missing data at Week 26 were assigned a status of nonresponder in the analysis.||20.89|6.91|= 0.0001
74016273|NCT00049673|147584109|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.18|TWO_SIDED|95.0|0.53|1.14|||Log Rank|||||1.14|0.53|0.18
74045421|NCT03180294|147642872|SUPERIORITY|||||||0.79||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.79
74045422|NCT03180294|147642873|SUPERIORITY|||||||0.41||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.41
74045423|NCT03180294|147642873|SUPERIORITY|||||||0.35||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.35
74016274|NCT00049673|147584110|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0001|TWO_SIDED|95.0|0.43|0.73|||Log Rank|||||0.73|0.43|0.0001
74016275|NCT02475681|147584111|SUPERIORITY||Hazard Ratio (HR)|0.1|||<|0.0001|TWO_SIDED|95.0|0.06|0.17|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The primary test to compare PFS between treatment arms was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR (Arm B/Arm A) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.17|0.06|<0.0001
74016276|NCT02475681|147584112|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.13|0.3|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare PFS between treatment Arms A and C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.30|0.13|<0.0001
74045424|NCT03180294|147642873|SUPERIORITY|||||||0.83||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.83
74045425|NCT03180294|147642873|SUPERIORITY|||||||0.79||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.79
74045426|NCT03180294|147642874|SUPERIORITY|||||||0.78||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.78
73880304|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0532|TWO_SIDED|95.0|0.98|10.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.64|0.98|0.0532
73880305|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1616|TWO_SIDED|95.0|0.73|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.76|0.73|0.1616
73880306|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.5||||0.432|TWO_SIDED|95.0|0.55|4.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.11|0.55|0.4320
73880307|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2231|TWO_SIDED|95.0|0.68|5.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.35|0.68|0.2231
73880308|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.88||||0.0347|TWO_SIDED|95.0|1.1|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.64|1.10|0.0347
74016277|NCT02475681|147584113|SUPERIORITY||Risk Difference (RD)|15.3|||<|0.0001|TWO_SIDED|95.0|8.3|22.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS||||22.3|8.3|<0.0001
74016278|NCT02475681|147584113|SUPERIORITY||Risk Difference (RD)|6.9||||0.0763|TWO_SIDED|95.0|-1.0|14.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS.||||14.9|-1.0|0.0763
74016279|NCT02475681|147584114|SUPERIORITY||Hazard Ratio (HR)|0.14|||<|0.0001|TWO_SIDED|95.0|0.08|0.26|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare TTNT between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.26|0.08|<0.0001
74016280|NCT02475681|147584114|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.15|0.4||P-value based on stratified by randomization stratification factors as recorded in IXRS|Log Rank|Stratified by randomization stratification factors as recorded in IXRS||||0.40|0.15|<0.0001
73880309|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0291|TWO_SIDED|95.0|1.17|18.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||18.07|1.17|0.0291
73880310|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2805|TWO_SIDED|95.0|0.61|5.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.38|0.61|0.2805
73880311|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0602|TWO_SIDED|95.0|0.95|10.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.11|0.95|0.0602
74045427|NCT03180294|147642874|SUPERIORITY|||||||0.51||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.51
74045428|NCT03180294|147642874|SUPERIORITY|||||||0.49||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.49
74045429|NCT03180294|147642874|SUPERIORITY|||||||0.5||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.50
74045430|NCT03180294|147642875|SUPERIORITY|||||||0.71|||||||Chi-squared|One-sided significance level 0.05||||||0.71
74045431|NCT03180294|147642875|SUPERIORITY|||||||0.34|||||||Chi-squared|One-sided significance level 0.05||||||0.34
74045432|NCT03180294|147642876|SUPERIORITY|||||||0.23||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.23
74045433|NCT03180294|147642876|SUPERIORITY|||||||0.25||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.25
74045434|NCT02037204|147642932|NON_INFERIORITY|A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.|||||<|0.05|||||||ANOVA|||A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.||||<0.05
74045435|NCT00524043|147642938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|4.2||0.504||95.0|-5.47|11.09||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Sample size estimation was based on the assumption that the difference between the paliperidone ER 1.5 mg dose group and the placebo group in the mean change in PANSS total score from baseline to end point was 11 points with a within-group standard deviation of 20 points. It was calculated that 65 patients were needed per treatment group to detect a statistically significant treatment difference between the paliperidone ER 1.5 mg dose group and the placebo group with a power of 87.5%.||11.09|-5.47|0.504
74045436|NCT00524043|147642938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|4.15||0.431||95.0|-11.46|4.9||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|Paliperidone ER 6 mg was used for assay sensitivity||||4.90|-11.46|0.431
74045437|NCT00524043|147642939|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||Based on ANCOVA model on ranks with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.626
74095684|NCT03753763|147741007|SUPERIORITY||Least square mean difference|0.8||||0.6393|TWO_SIDED|95.0|-2.5|4.0|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change from baseline in UDRS.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||4.0|-2.5|0.6393
74095685|NCT01104779|147741008|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0029|TWO_SIDED|95.0|-11.3|-2.4|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo|||-2.4|-11.3|0.0029
74095686|NCT01104779|147741008|SUPERIORITY||Mean Difference (Final Values)|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.5|-5.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo|||-5.3|-14.5|<0.0001
74095687|NCT01104779|147741009|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0115|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo|||-0.1|-0.6|0.0115
74095688|NCT01104779|147741009|SUPERIORITY||Mean Difference (Final Values)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo|||-0.3|-0.8|<0.0001
73880312|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5087|TWO_SIDED|95.0|0.51|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.88|0.51|0.5087
73880313|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1224|TWO_SIDED|95.0|0.8|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.38|0.80|0.1224
73880314|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.85||||0.228|TWO_SIDED|95.0|0.68|5.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.02|0.68|0.2280
74045438|NCT00524043|147642940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.69||0.87||95.0|-4.86|5.74||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||5.74|-4.86|0.870
74045439|NCT00524043|147642941|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.126
74045440|NCT00524043|147642942|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.691
74095689|NCT03982199|147741012|SUPERIORITY||Event Rate|80.0||||4e-05|TWO_SIDED|94.211|52.2|92.9|||Poisson regression|||Case Definition 1||92.9|52.2|0.00004
74045441|NCT02773368|147643003|NON_INFERIORITY|Non-inferiority of IDegLira was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (IDegLira minus IGlar) was strictly below 0.3%.|Treatment Contrast|-0.34|||||TWO_SIDED|95.0|-0.48|-0.2|||ANCOVA||IDegLira minus IGlar|Analysis was based on ANCOVA model with treatment, pre-trial OAD, region as factors and baseline HbA1c as covariate. Data obtained after premature treatment discontinuation are included in the analysis. Missing data was imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation. The non-inferiority margin of 0.3 % was added to the end-of-treatment value for prematurely discontinued and withdrawn from trial IDegLira subjects.||-0.20|-0.48|
74095690|NCT03982199|147741012|SUPERIORITY||Event Rate|75.0||||1e-05|TWO_SIDED|94.211|50.1|88.5|||Poisson regression|||Case Definition 2||88.5|50.1|0.00001
73880315|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1835|TWO_SIDED|95.0|0.71|6.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.02|0.71|0.1835
73880316|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|5.85||||0.0107|TWO_SIDED|95.0|1.51|22.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||22.69|1.51|0.0107
74095691|NCT03982199|147741012|SUPERIORITY||Event Rate|69.8||||4e-05|TWO_SIDED|94.211|43.7|84.7|||Poisson regression|||Case Definition 3||84.7|43.7|0.00004
74095692|NCT05011123|147741098|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-5%|Difference in percentage of participants|-1.2|||||TWO_SIDED|95.0|-3.4|1.8|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||1.8|-3.4|
74095693|NCT05011123|147741099|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-5%|Difference in percentage of participants|-0.9|||||TWO_SIDED|95.0|-4.0|3.0|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||3.0|-4.0|
74095694|NCT00006721|147741111|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.11|TWO_SIDED|95.0|0.6|1.05|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab|||1.05|0.6|0.11
74095695|NCT00006721|147741115|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.55||||0.08|TWO_SIDED|95.0|0.95|2.54|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab|||2.54|0.95|0.08
74095696|NCT04732221|147741117|SUPERIORITY||Treatment difference|-9.2||||0.068|TWO_SIDED|95.0|-21.3|2.9||A 1-sided p-value was obtained from fitting a Robust regression estimate based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||2.9|-21.3|0.068
74016281|NCT02475681|147584115|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.0577|TWO_SIDED|95.0|0.21|1.06|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare overall survival between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||1.06|0.21|0.0577
74016282|NCT02475681|147584115|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.1556|TWO_SIDED|95.0|0.28|1.27|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||||1.27|0.28|0.1556
74016283|NCT01262365|147584122|SUPERIORITY||Odds Ratio (OR)|1.307|||=|0.175|TWO_SIDED|95.0|0.888|1.923|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.||1.923|0.888|=0.175
74016284|NCT01262365|147584122|SUPERIORITY||Odds Ratio (OR)|1.164|||=|0.442|TWO_SIDED|95.0|0.79|1.714|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.||1.714|0.790|=0.442
74016285|NCT02322710|147584134|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the 95% confidence interval of the observed difference between healing rates at D21 (Urgotul® - Tullegras M.S.®) in the PP population did not exceed +10%.|Difference in Percentages|1.2|STANDARD_DEVIATION|4.5|||ONE_SIDED|97.5||10.0||||||||10.0||
74016286|NCT04316585|147584173|SUPERIORITY||Mean Difference (Final Values)|-2.28|||||TWO_SIDED|95.0|-9.19|8.28|||Bayesian Logistic Regression Model|The model was adjusted for treatment (GSK2982772 vs placebo), baseline PASI score and prior biologic use (yes/no).|Posterior median and 95% CrI for the true difference in proportion of responders (GSK2982772 - placebo).|Bayesian logistic regression. An informative prior was used for the placebo response in this statistical analysis, the prior for placebo response rate was of the form: 90% weight on Be (5.39, 69) and 10% on Be (1/3,1/3). The prior was derived from historical data from similar clinical trials using meta-analytic predictive prior (MAP) approach. All other parameters took vague priors.||8.28|-9.19|
74016287|NCT04316585|147584173|SUPERIORITY||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-4.81|8.07|||Bayesian Logistic Regression Model|The model was adjusted for treatment (GSK2982772 vs placebo), baseline PASI score and prior biologic use (yes/no).|Posterior median and 95% CrI for the true difference in proportion of responders (GSK2982772 - placebo).|||8.07|-4.81|
74016288|NCT01394081|147584190|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||||||<.0001
74016289|NCT01394081|147584191|SUPERIORITY||||||<|0.0001|||||||Log Rank|log rank Mantel Cox χ2 = 25.4||||||<.0001
74095697|NCT04732221|147741117|SUPERIORITY||Treatment difference|-22.0|||<|0.001|TWO_SIDED|95.0|-33.7|-10.3||based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||-10.3|-33.7|<0.001
74016290|NCT02814565|147584204|SUPERIORITY|||||||0.6179|TWO_SIDED|95.0|||||Wilcoxon Rank Sum test|||The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.6179
74016291|NCT02814565|147584205|SUPERIORITY|||||||0.4338|||||||Wilcoxon Rank Sum Test|||Day 7. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4338
74016292|NCT02814565|147584205|SUPERIORITY|||||||0.1657|||||||Wilcoxon Rank Sum Test|||Day 14. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.1657
74016293|NCT02814565|147584206|SUPERIORITY|||||||0.0393|||||||Wilcoxon Sum Rank Test|||The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0393
74016294|NCT02814565|147584207|SUPERIORITY|||||||0.033|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0330
74016295|NCT02814565|147584207|SUPERIORITY|||||||0.0262|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0262
74016296|NCT02814565|147584208|SUPERIORITY|||||||0.5756|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.5756
74016297|NCT02814565|147584208|SUPERIORITY|||||||0.4395|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4395
74016298|NCT02814565|147584208|SUPERIORITY|||||||0.0905|||||||Wilcoxon Sum Rank Test|||Day 14. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0905
74016299|NCT02814565|147584209|SUPERIORITY|||||||1|||||||Fisher Exact|||"Day 3. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||1.0000
74045442|NCT02773368|147643003|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change and the number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in HbA1c was strictly below 0%.|Treatment Contrast|-0.36|||||TWO_SIDED|95.0|-0.5|-0.21|||ANCOVA||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline value as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-0.21|-0.50|
74095698|NCT04732221|147741117|SUPERIORITY||Treatment difference|-19.9||||0.002|TWO_SIDED|95.0|-33.4|-6.4||A 1-sided p-value was obtained from fitting a Robust regression estimate based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||-6.4|-33.4|0.002
74016300|NCT02814565|147584209|SUPERIORITY|||||||1|||||||Fisher Exact|||"Day 7. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||1.0000
74016301|NCT02814565|147584209|SUPERIORITY|||||||0.2757|||||||Fisher Exact|||"Day 14. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||0.2757
74016302|NCT02814565|147584210|SUPERIORITY|||||||0.302|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.3020
74016303|NCT02814565|147584210|SUPERIORITY|||||||0.2367|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2367
74016304|NCT02814565|147584210|SUPERIORITY|||||||0.025|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0250
74016305|NCT02814565|147584211|SUPERIORITY|||||||0.4428|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4428
74016306|NCT02814565|147584211|SUPERIORITY|||||||0.1163|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.1163
74095699|NCT02752906|147741156|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non- inferiority assumption was rejected.|Percentage Difference|5.0|||||TWO_SIDED|95.0|0.735|9.38||||||Serogroup A||9.38|0.735|
74016307|NCT02814565|147584211|SUPERIORITY|||||||0.0489|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0489
74016308|NCT02814565|147584212|SUPERIORITY|||||||0.5275|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.5275
74016309|NCT02814565|147584212|SUPERIORITY|||||||0.088|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0880
74016310|NCT02814565|147584212|SUPERIORITY|||||||0.2542|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2542
74016311|NCT02814565|147584213|SUPERIORITY|||||||0.692|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.6920
74016312|NCT02814565|147584213|SUPERIORITY|||||||0.0749|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0749
74016313|NCT02814565|147584213|SUPERIORITY|||||||0.2371|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2371
74016314|NCT01885000|147584229|SUPERIORITY||||||=|0.0065|||||||Cochran-Mantel-Haenszel|||||||= 0.0065
74016315|NCT01885000|147584230|SUPERIORITY||||||=|0.0328|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who satisfied with appearance.||||= 0.0328
74095700|NCT02752906|147741156|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|5.4|||||TWO_SIDED|95.0|2.16|8.76||||||Serogroup C||8.76|2.16|
74016316|NCT01885000|147584230|SUPERIORITY||||||=|0.5312|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who appearance acceptable.||||= 0.5312
74016317|NCT01885000|147584230|SUPERIORITY||||||=|0.0756|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who appearance concerned.||||= 0.0756
74016318|NCT01885000|147584230|SUPERIORITY||||||=|0.0083|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who embarrassed with facial redness.||||= 0.0083
74016319|NCT01885000|147584230|SUPERIORITY||||||=|0.0076|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who self-conscious.||||= 0.0076
74016320|NCT01885000|147584230|SUPERIORITY||||||=|0.2186|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who's frequency control last 24 hours||||= 0.2186
74016321|NCT01885000|147584230|SUPERIORITY||||||=|0.2373|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who are frustrated.||||= 0.2373
74016322|NCT01885000|147584230|SUPERIORITY||||||=|0.7769|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who cover up or camouflage.||||= 0.7769
74016323|NCT01885000|147584230|SUPERIORITY||||||=|0.8764|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who pay attention to the known triggers.||||= 0.8764
74016324|NCT01885000|147584230|SUPERIORITY||||||=|0.6149|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who avoid the known triggers.||||= 0.6149
74016325|NCT01885000|147584230|SUPERIORITY||||||=|0.8361|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who interfering with social life.||||= 0.8361
74016326|NCT01885000|147584230|SUPERIORITY||||||=|0.6259|||||||Cochran-Mantel-Haenszel|||Interfering with work life||||= 0.6259
74016327|NCT01885000|147584231|SUPERIORITY||||||=|0.5821|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Mobility.||||= 0.5821
74016328|NCT01885000|147584231|SUPERIORITY||||||=|0.8864|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Self-Care.||||= 0.8864
74016329|NCT01885000|147584231|SUPERIORITY||||||=|0.9579|||||||Cochran-Mantel-Haenszel|||This analysis was performed for usual activities.||||= 0.9579
74016330|NCT01885000|147584231|SUPERIORITY||||||=|0.1344|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Pain/Discomfort.||||= 0.1344
74016331|NCT01885000|147584231|SUPERIORITY||||||=|0.1881|||||||Cochran-Mantel-Haenszel|||Anxiety/Depression||||= 0.1881
74016332|NCT01885000|147584232|SUPERIORITY||||||=|0.3935|||||||Cochran-Mantel-Haenszel|||||||= 0.3935
74016333|NCT01885000|147584233|SUPERIORITY||||||=|0.4162|||||||Cochran-Mantel-Haenszel|||||||= 0.4162
74016334|NCT03124784|147584238|EQUIVALENCE|ARMS\<= 3 %SpO2 Error per International Organization For Standardization (ISO) -80601-2-61 Pilot study Monte Carlo simulation provided 80% Power with 25 subjects for an expected ARMS\< 3 % SpO2.|ARMS|0.0|||||TWO_SIDED|||||||||Accuracy Root Mean Square (ARMS)|Per ISO-80601-2-61, the Root Mean Square difference (SpO2-SaO2) is the measure of merit for desaturation studies.|||
74016335|NCT02469090|147584271|SUPERIORITY||LS mean differnce|-7.6|STANDARD_ERROR_OF_MEAN|1.96||0.0002|TWO_SIDED|95.0|-11.5|-3.7||The null-hypothesis to be tested was: H0: APL-130277 is the same as placebo in its effect on the motor function against the 2-sided alternative: H1: Either of the treatment groups is superior to the other in its effect on the motor function.|LS mean difference|To control the family-wise type I error rate, the primary and secondary end points were tested in hierarchical order in the order presented||Mixed effects model for repeated measures (MMRM) was used to estimate the treatment difference(APL-130277-placebo) Observed change from pre-dose MDS-UPDRS Part III score values after 30 minutes were response values. Treatment group, visit and the interaction between the treatment group and visit were fixed factors. Change from pre-dose in MDS-UPDRS Part III score after 30 minutes at the last TV at which the randomized dose was given up through TV6 was used as a covariate||-3.7|-11.5|0.0002
74016336|NCT02469090|147584272|SUPERIORITY||Adjusted odds ratio|2.81||||0.0426|TWO_SIDED|95.0|1.036|7.644|||Adjusted Odds Ratio|||"This was analyzed using a generalized linear mixed model (with logit link function) for binomial data. The model included the observed outcomes as the response values, with treatment group, visit, and the interaction between treatment group and visit as fixed factors and the ON/OFF assessment at the last open-label titration visit at which the randomized dose was given as a covariate."||7.644|1.036|0.0426
74016337|NCT02469090|147584273|SUPERIORITY||Adjusted odds ratio|2.8||||0.0501|TWO_SIDED|95.0|1.0|7.84||The hierarchical testing stopped at this endpoint due to non-significant result. P-values for endpoints after this endpoint have not been presented and the confidence interval presented are unadjusted for multiplicity.|Adjusted odds ratio|||"This was analyzed using a generalized linear mixed model (with logit link function) for binomial data. The model included the observed outcomes as the response values, with treatment group, visit, and the interaction between treatment group and visit as fixed factors and the ON/OFF assessment at the last open-label titration visit at which the randomized dose was given as a covariate."||7.84|1.00|0.0501
74016338|NCT02469090|147584276|SUPERIORITY||LS mean difference|-1.1|||||TWO_SIDED|95.0|-3.159|0.959||||||||0.959|-3.159|
74095701|NCT02752906|147741156|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-0.907|4.55||||||Serogroup Y||4.55|-0.907|
74016339|NCT02469090|147584277|SUPERIORITY||LS mean difference|47.6|||||TWO_SIDED|95.0|28.84|66.36||||||||66.36|28.84|
74016340|NCT02469090|147584278|SUPERIORITY||LS mean difference|1.979|||||TWO_SIDED|95.0|-2.162|6.12||||||||6.120|-2.162|
74016341|NCT02469090|147584279|SUPERIORITY||LS mean difference|-3.4|||||TWO_SIDED|95.0|-6.7|-0.2||||||||-0.2|-6.7|
74016342|NCT02469090|147584280|SUPERIORITY||Hazard ratio|3.4|||||TWO_SIDED|95.0|1.99|5.69||||||Median Time to effect for APL-130277 versus placebo patients||5.69|1.99|
74016343|NCT05215600|147584282|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.001|||||||t-test, 2 sided|T-Test (Pooled)||||||<0.001
74016344|NCT05215600|147584283|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.001|||||||t-test, 2 sided|T-Test (Pooled)||||||<0.001
74016345|NCT00355394|147584321|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
74016346|NCT00355394|147584322|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
74016347|NCT00355394|147584323|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.46
74095702|NCT02752906|147741156|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|7.4|||||TWO_SIDED|95.0|4.3|10.9||||||Serogroup W||10.9|4.30|
74095703|NCT03244644|147741182|SUPERIORITY||Treatment Difference|13.1|||||TWO_SIDED|95.0|2.3|24.0|||||The Bayesian posterior probability of superiority was 0.99136. This value exceeded the pre-specified threshold of 0.9750338 (nominal 0.025 one-sided level).|A hierarchical, closed-testing procedure (Bayesian hierarchical model) was utilized for the primary endpoint. The Bayesian hierarchical model formally incorporated data from the previous Phase 2B study (NCT02299570) of RBX2660. This analysis tested the hypothesis that the response rate of RBX2660 was superior to Placebo and was performed at the nominal 0.00125 and 0.025 one-sided levels.||24.0|2.3|
74095704|NCT03244644|147741183|SUPERIORITY|||||||0.156||||||P-value for secondary outcome evaluated from baseline through 6 months|Chi-squared|||||||0.156
74095705|NCT04796779|147741226|SUPERIORITY||||||<|0.001|||||||Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
74095706|NCT04796779|147741227|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Robust regression using M-estimation|The model was adjusted for baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.||||||<0.001
74016348|NCT00355394|147584324|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
74095707|NCT04796779|147741228|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
74095708|NCT04796779|147741229|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
74095709|NCT04796779|147741230|SUPERIORITY|||||||0.57||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Robust regression using M-estimation|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.||||||0.57
74016349|NCT00355394|147584325|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
74095710|NCT00910091|147741302|SUPERIORITY_OR_OTHER|||||||0.1895|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.1895
74095711|NCT00910091|147741303|SUPERIORITY_OR_OTHER|||||||0.0203|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.0203
74095712|NCT00910091|147741305|SUPERIORITY_OR_OTHER|||||||0.698|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.6980
74095713|NCT00910091|147741306|SUPERIORITY_OR_OTHER|||||||0.3078|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.3078
74095714|NCT00910091|147741307|SUPERIORITY_OR_OTHER|||||||0.0484|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.0484
74095715|NCT01659866|147741316|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74095716|NCT02109419|147741324|OTHER||Pearson Test-retest reliability coeff.|0.8|||<|0.0001|TWO_SIDED||||||Pearson Test-retest reliability coeff.|||HHT-D reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.||||<0.0001
74095717|NCT02109419|147741324|OTHER||Pearson test-retest reliability coeff|0.87|||<|0.0001|TWO_SIDED||||||Pearson test-retest reliability coeff|||HHT-G reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.||||<0.0001
74095718|NCT02109419|147741324|OTHER||Pearson correlation coefficient|0.6|||<|0.0001|TWO_SIDED||||||Pearson correlation coefficient|||Validity of the HHT-D was tested by Pearson correlation coefficients between HHT-D and Geriatric Depression Scale (GDS) scores. The dataset included participants from all groups.||||<.0001
74095719|NCT02109419|147741324|OTHER||Pearson correlation coefficient|0.71||||0.0001|TWO_SIDED||||||Pearson correlation coefficient|||Validity of the HHT-G was tested by Pearson correlation coefficients between HHT-G and Mini-Mental State Examination (MMSE) scores. The dataset included participants from all groups.||||0.0001
74095720|NCT02109419|147741324|OTHER||Chronbach's alpha|0.73|||||TWO_SIDED|||||||||Internal consistency reliability of the HHT-D was assessed with Chronbach's alpha. The dataset included participants from all groups.||||
74095721|NCT02109419|147741324|OTHER||Chronbach's alpha|0.7|||||TWO_SIDED|||||||||Internal consistency reliability of the HHT-G was assessed with Chronbach's alpha. The dataset included participants from all groups.||||
74095722|NCT03560986|147741360|SUPERIORITY||Mean Difference (Net)|0.43|STANDARD_ERROR_OF_MEAN|0.372||0.2522|TWO_SIDED|95.0|-0.31|1.17||2-sided p-value for testing superiority of neridronic acid 400 mg compared to placebo.|Mixed Models Analysis|The degrees of freedom of the denominator are estimated using the Kenward-Roger approximation.|The primary endpoint estimate was the least squares mean differences of change from baseline in pain NRS (electronic diary) at Week 12 between neridronate and Placebo.|Mixed-effects model for repeated measures (MMRM) defined with baseline pain intensity as covariate, the factors geographic region, week, treatment and treatment-by-week as fixed effects, and an unstructured covariance matrix to model the covariance structure of the repeated measurements.||1.17|-0.31|0.2522
74016350|NCT00355394|147584326|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.50
74016351|NCT00411554|147584337|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin (Sitagliptin minus Voglibose) = 0.2 percent|Least-squares Mean Difference|-0.39|||<|0.001||95.0|-0.51|-0.28||"This p-value corresponds to a test of superiority that was performed after success was achieved in the test of non-inferiority (reported under Estimation below), according to the pre-specified analysis plan"|ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show non-inferiority and superiority to voglibose (closed procedure) and to estimate difference of two groups and its 95% confidence interval|||-0.28|-0.51|<0.001
74016352|NCT00411554|147584338|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-10.7|||<|0.001||95.0|-15.3|-6.2|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval|||-6.2|-15.3|<0.001
74016353|NCT00411554|147584339|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-18.8|||<|0.001||95.0|-26.7|-10.9|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval|||-10.9|-26.7|<0.001
74016354|NCT03728309|147584348|SUPERIORITY||Percentage Difference|53.5|||<|0.001|TWO_SIDED|95.0|43.5|63.5||The p-value and 95% CI are computed by pooling 30 imputed data sets using SAS PROC MIANALYZE with normal approximation.|SAS PROC MIANALYZE|||||63.5|43.5|<0.001
74016355|NCT03728309|147584350|SUPERIORITY||Mean Difference (Final Values)|28.0|STANDARD_ERROR_OF_MEAN|3.83|<|0.001|TWO_SIDED|95.0|21.0|36.0|||2-sample, t-test|||||36.0|21.0|<0.001
74016356|NCT03728309|147584351|SUPERIORITY||Percentage Difference|52.9|||<|0.001|TWO_SIDED|95.0|40.1|65.7|||Fisher's Exact Test||Comparison of treatment group versus control group at Month 1, responder rate difference, 95% CI for risk difference and p-value was estimated based on Fisher's exact test using mITT population with baseline AFLS score of 2 or 3 on both cheeks.|||65.7|40.1|<0.001
74016357|NCT02682901|147584390|SUPERIORITY|||||||0.603||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.603
74016358|NCT02682901|147584391|SUPERIORITY|||||||0.068||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.068
74045443|NCT02773368|147643004|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in body weight was strictly below 0 kg.|Treatment Contrast|-1.92|||||TWO_SIDED|95.0|-2.64|-1.19|||ANCOVA||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline weight as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-1.19|-2.64|
74045444|NCT02773368|147643005|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c and superiority of IDegLira was confirmed for change from baseline in body weight) and if the upper limit of the two-sided 95% CI for the rate ratio (IDegLira over IGlar) of rate of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes was strictly below 1.|Treatment Ratio|0.42|||||TWO_SIDED|95.0|0.23|0.75|||Negative binomial regression model||IDegLira over IGlar|This endpoint was analysed using a negative binomial regression model with a log link and the logarithm of the exposure time as offset. The model included treatment and pre-trial OAD as fixed factors. Missing data were imputed using multiple imputations (conditioning on expected event rate before premature treatment discontinuation or withdrawal from trial as if treated with IGlar).||0.75|0.23|
74095723|NCT00593736|147741374|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the analysis of covariance (ANCOVA) model.||||0.646
74095724|NCT00593736|147741374|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.084
74095725|NCT00593736|147741374|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.929
74016359|NCT02682901|147584392|SUPERIORITY|||||||0.493||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.493
74016360|NCT02682901|147584393|SUPERIORITY|||||||0.524||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.524
74016361|NCT02682901|147584394|SUPERIORITY|||||||0.63||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.630
74016362|NCT02682901|147584395|SUPERIORITY|||||||0.537||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.537
74016363|NCT02682901|147584396|SUPERIORITY|||||||0.53||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.530
74016364|NCT02682901|147584397|SUPERIORITY|||||||0.005||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.005
74016365|NCT01097304|147584443|OTHER|||||||0.54|||||||t-test, 2 sided|||||||0.54
74016366|NCT01097304|147584444|OTHER||||||<|0.0001|||||||signed rank test|||||||<0.0001
74016367|NCT01097304|147584445|OTHER||||||<|0.01|||||||signed rank test|||||||<0.01
74016368|NCT01097304|147584446|OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
74045445|NCT02773368|147643006|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change, number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and change in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in insulin dose after 26 weeks was strictly below 0 U.|Treatment Contrast|-15.37|||||TWO_SIDED|95.0|-19.6|-11.13|||ANCOVA||IDegLira minus IGlar|The endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline HbA1c as covariate. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-11.13|-19.60|
74045446|NCT01789255|147643044|OTHER|||||||0.02642|||||||Wilcoxon (Mann-Whitney)|||||||0.02642
74045447|NCT01789255|147643045|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
74045448|NCT02635867|147643046|SUPERIORITY|Descriptive data and rates of success were calculated independently for indirect and direct therapies. Statistical analyses of proportions were done using Fisher's test and 95% confidence intervals (CI)|||||>|0.1|||||||Fisher Exact|||"The clinical outcome measures assessed were pain using visual analog pain scale, pulp vitality assessment at 12 months.~The success rate was based on 3 measures of pulp vitality that resulted in a diagnosis of vital or nonvital:~Vital: palpation = negative/ percussion = negative/ response to cold stimuli= positive response Non vital: palpation = positive / percussion = positive. / response to cold stimuli= positive or delayed response time in seconds and lingering."||||>0.1
74095726|NCT00593736|147741375|SUPERIORITY_OR_OTHER|||||||0.854||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.854
74016369|NCT02799069|147584447|NON_INFERIORITY|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.0|||||ONE_SIDED|97.5|5.9||||||||||5.9|
74016370|NCT02799069|147584447|SUPERIORITY||Difference to BF-200 ALA|61.1||||0|TWO_SIDED|95.0|51.2|71.0|||Chi-squared|||"Superiority of BF-200 ALA compared to placebo:~A sample size of 264: 88 patients (BF-200 ALA: placebo) will have a power of more than 90% to establish superiority of BF-200 ALA over placebo, even if very conservative response rates of 65% for the BF-200 ALA group and 40% for placebo are assumed using a chi-square test with continuity correction and a two-sided significance level of 0.05."||71.0|51.2|0.0000
74016371|NCT02799069|147584448|NON_INFERIORITY|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.2|||||ONE_SIDED|97.5|6.0||||||||||6.0|
74016372|NCT02799069|147584448|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|59.4||||0|TWO_SIDED|95.0|48.4|70.4|||Chi-squared|||||70.4|48.4|0.0000
74045449|NCT00329784|147643057|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74045450|NCT00329784|147643057|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||||||0.004
74045451|NCT00329784|147643058|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74045452|NCT00329784|147643059|SUPERIORITY_OR_OTHER|||||||0.369|||||||Wilcoxon (Mann-Whitney)|||||||0.369
74045453|NCT00329784|147643060|SUPERIORITY_OR_OTHER|||||||0.642|||||||Chi-squared|||||||0.642
74045454|NCT00329784|147643061|SUPERIORITY_OR_OTHER|||||||0.417|||||||Chi-squared|||Comparison for Seasonal Rhinoconjunctivitis||||0.417
74045455|NCT00329784|147643061|SUPERIORITY_OR_OTHER|||||||0.926|||||||Chi-squared|||Comparison for Perennial Rhinoconjunctivitis||||0.926
74045456|NCT00329784|147643062|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison for Peanut Wheal||||<0.001
74045457|NCT00329784|147643062|SUPERIORITY_OR_OTHER|||||||0.361|||||||Chi-squared|||Comparison for Egg Wheal||||0.361
74045458|NCT00329784|147643062|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Comparison for Milk Wheal||||0.760
74045459|NCT00329784|147643062|SUPERIORITY_OR_OTHER|||||||0.834|||||||Chi-squared|||Comparison for Sesame Wheal||||0.834
74045460|NCT00329784|147643062|SUPERIORITY_OR_OTHER|||||||0.882|||||||Chi-squared|||Comparison for Brazil Nut Wheal||||0.882
74045461|NCT00329784|147643062|SUPERIORITY_OR_OTHER|||||||0.226|||||||Chi-squared|||Comparison for Hazel Nut Wheal||||0.226
74016373|NCT02799069|147584449|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|72.0||||0|TWO_SIDED|95.0|59.7|84.2|||Chi-squared|||||84.2|59.7|0.0000
74016374|NCT02799069|147584449|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|17.3|||||ONE_SIDED|97.5|6.6||||||||||6.6|
74016375|NCT01844895|147584507|SUPERIORITY_OR_OTHER||geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||A mixed-effect model of log (Cminss) with device and substudy baseline weight category (\< 60 kg,60-100 kg, \> 100 kg) as fixed effects and participant as a random effect was used. Point estimates and 90% CIs for device differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale. No adjustment was made for multiplicity. PK comparability was concluded if the 90% CIs for the ratios of geometric means were contained within 80% to 125%.||1.00|0.83|
74016376|NCT06245551|147584519|OTHER|The analysis is applied to the All-subjects data.|Mean Difference (Final Values)|-17.52|||<|0.001|TWO_SIDED|95.0|-19.78|-15.25|||Mixed Models Analysis|||||-15.25|-19.78|<0.001
74016377|NCT00511355|147584525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0849||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0849
74016378|NCT00511355|147584527|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
73880317|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0576|TWO_SIDED|95.0|0.97|8.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.96|0.97|0.0576
73880318|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|9.68||||0.0047|TWO_SIDED|95.0|2.0|46.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||46.77|2.00|0.0047
73880319|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0569|TWO_SIDED|95.0|0.97|8.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.64|0.97|0.0569
73880320|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1078|TWO_SIDED|95.0|0.83|6.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.68|0.83|0.1078
73880321|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0772|TWO_SIDED|95.0|0.9|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.47|0.90|0.0772
73880322|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.36||||0.1311|TWO_SIDED|95.0|0.77|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.22|0.77|0.1311
73880323|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|5.64||||0.01255|TWO_SIDED|95.0|1.45|21.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||21.96|1.45|0.01255
73880324|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.97||||0.0128|TWO_SIDED|95.0|1.41|17.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||17.54|1.41|0.0128
74016379|NCT00511355|147584528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4191||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.4191
73880325|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|6.32||||0.0079|TWO_SIDED|95.0|1.62|24.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||24.63|1.62|0.0079
73880326|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0572|TWO_SIDED|95.0|0.97|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.67|0.97|0.0572
73880327|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0284|TWO_SIDED|95.0|1.14|9.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.79|1.14|0.0284
73880328|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0705|TWO_SIDED|95.0|0.92|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.22|0.92|0.0705
73880329|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.81||||0.0136|TWO_SIDED|95.0|1.38|16.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.77|1.38|0.0136
73880330|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|9.96||||0.0043|TWO_SIDED|95.0|2.06|48.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||48.29|2.06|0.0043
73880331|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.66||||0.076|TWO_SIDED|95.0|0.9|7.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.83|0.90|0.0760
74016380|NCT00511355|147584529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0010
74016381|NCT00511355|147584533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3779||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.3779
74045462|NCT00329784|147643062|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||Comparison for Cashew Wheal||||0.024
74045463|NCT00329784|147643062|SUPERIORITY_OR_OTHER|||||||0.204|||||||Chi-squared|||Comparison for Walnut Wheal||||0.204
74045464|NCT00329784|147643062|SUPERIORITY_OR_OTHER|||||||0.194|||||||Chi-squared|||Comparison for Almond Wheal||||0.194
74045465|NCT00329784|147643063|SUPERIORITY_OR_OTHER|||||||0.859|||||||Chi-squared|||Comparison for Peanut IgE||||0.859
73880332|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|5.75||||0.0059|TWO_SIDED|95.0|1.65|20.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.00|1.65|0.0059
73880333|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|4.22||||0.0143|TWO_SIDED|95.0|1.33|13.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||13.35|1.33|0.0143
73880334|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2779|TWO_SIDED|95.0|0.62|5.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.35|0.62|0.2779
73880335|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7559|TWO_SIDED|95.0|0.41|3.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.41|0.41|0.7559
73880336|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.07||||0.905|TWO_SIDED|95.0|0.35|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.23|0.35|0.9050
73880337|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.05||||0.2163|TWO_SIDED|95.0|0.66|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.38|0.66|0.2163
73880338|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.24||||0.1713|TWO_SIDED|95.0|0.7|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.14|0.70|0.1713
73880339|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3981|TWO_SIDED|95.0|0.52|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.09|0.52|0.3981
73880340|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9692|TWO_SIDED|95.0|0.35|2.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.96|0.35|0.9692
73880341|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.77||||0.2978|TWO_SIDED|95.0|0.6|5.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.22|0.60|0.2978
73880342|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8525|TWO_SIDED|95.0|0.38|3.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.18|0.38|0.8525
73880343|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|0.67||||0.5028|TWO_SIDED|95.0|0.21|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.13|0.21|0.5028
73880344|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.53||||0.4594|TWO_SIDED|95.0|0.5|4.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.73|0.50|0.4594
73880345|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.56||||0.1124|TWO_SIDED|95.0|0.8|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||8.17|0.80|0.1124
73880346|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3415|TWO_SIDED|95.0|0.55|5.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.58|0.55|0.3415
73880347|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3635|TWO_SIDED|95.0|0.56|4.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.83|0.56|0.3635
73888054|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.2009|TWO_SIDED|95.0|-6.0|28.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.1|-6.0|0.2009
74045466|NCT00329784|147643063|SUPERIORITY_OR_OTHER|||||||0.885|||||||Chi-squared|||Comparison for Egg IgE||||0.885
74045467|NCT00329784|147643063|SUPERIORITY_OR_OTHER|||||||0.403|||||||Chi-squared|||Comparison for Milk IgE||||0.403
74045468|NCT00329784|147643063|SUPERIORITY_OR_OTHER|||||||0.106|||||||Chi-squared|||Comparison for Sesame IgE||||0.106
74045469|NCT00329784|147643063|SUPERIORITY_OR_OTHER|||||||0.202|||||||Chi-squared|||Comparison for Brazil Nut IgE||||0.202
74045470|NCT00329784|147643063|SUPERIORITY_OR_OTHER|||||||0.108|||||||Chi-squared|||Comparison for Hazel Nut IgE||||0.108
74045471|NCT00329784|147643063|SUPERIORITY_OR_OTHER|||||||0.157|||||||Chi-squared|||Comparison for Cashew IgE||||0.157
73880348|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|0.73||||0.5716|TWO_SIDED|95.0|0.24|2.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.20|0.24|0.5716
73880349|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5028|TWO_SIDED|95.0|0.23|2.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.05|0.23|0.5028
73880350|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3982|TWO_SIDED|95.0|0.18|1.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.98|0.18|0.3982
73880351|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.3|2.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.87|0.30|0.93
73880352|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|2.12||||0.2364|TWO_SIDED|95.0|0.61|7.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.32|0.61|0.2364
73880353|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|1.25||||0.7095|TWO_SIDED|95.0|0.39|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.04|0.39|0.7095
73880354|NCT03192176|147297621|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6011|TWO_SIDED|95.0|0.26|2.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.20|0.26|0.6011
73880355|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|6.78||||0.0181|TWO_SIDED|95.0|1.39|33.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.10|1.39|0.0181
73880356|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|9.97||||0.0039|TWO_SIDED|95.0|2.1|47.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||47.48|2.10|0.0039
73880357|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|21.2||||0.0001|TWO_SIDED|95.0|4.51|99.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||99.65|4.51|0.0001
73880358|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|23.97|||<|0.0001|TWO_SIDED|95.0|5.09|112.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||112.9|5.09|<0.0001
73880359|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.17||||0.1766|TWO_SIDED|95.0|0.59|16.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.87|0.59|0.1766
74016382|NCT00511355|147584534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5027||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.5027
73880360|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|7.68||||0.0116|TWO_SIDED|95.0|1.58|37.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||37.43|1.58|0.0116
73880361|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|12.74||||0.0013|TWO_SIDED|95.0|2.71|59.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||59.81|2.71|0.0013
73880362|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0359|TWO_SIDED|95.0|1.07|7.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.43|1.07|0.0359
73880363|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|5.8||||0.0004|TWO_SIDED|95.0|2.2|15.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||15.33|2.20|0.0004
73880364|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|7.13|||<|0.0001|TWO_SIDED|95.0|2.68|18.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.98|2.68|<0.0001
74016383|NCT00511355|147584535|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0041
74095727|NCT00593736|147741375|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.383
74095728|NCT00593736|147741375|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.883
73880365|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|6.84||||0.0001|TWO_SIDED|95.0|2.53|18.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.46|2.53|0.0001
74045472|NCT00329784|147643063|SUPERIORITY_OR_OTHER|||||||0.04|||||||Chi-squared|||Comparison for Walnut IgE||||0.040
74045473|NCT00329784|147643063|SUPERIORITY_OR_OTHER|||||||0.262|||||||Chi-squared|||Comparison for Almond IgE||||0.262
74045474|NCT00838383|147643064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-70.0||||0.5307|TWO_SIDED|95.0|-291.3|151.4|||ANCOVA|||||151.4|-291.3|0.5307
74045475|NCT00838383|147643064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-73.2||||0.5121|TWO_SIDED|95.0|-294.5|148.2|||ANCOVA|||||148.2|-294.5|0.5121
74045476|NCT00838383|147643065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-123.1||||0.2735|TWO_SIDED|95.0|-345.5|99.3|||ANCOVA|||||99.3|-345.5|0.2735
74045477|NCT00838383|147643065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-174.5||||0.1223|TWO_SIDED|95.0|-396.8|47.9|||ANCOVA|||||47.9|-396.8|0.1223
74045478|NCT00838383|147643066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-66.6||||0.5505|TWO_SIDED|95.0|-288.0|154.8|||ANCOVA|||||154.8|-288.0|0.5505
74045479|NCT00838383|147643066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-110.3||||0.3237|TWO_SIDED|95.0|-331.7|111.0|||ANCOVA|||||111.0|-331.7|0.3237
74045480|NCT00838383|147643067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-166.5||||0.1412|TWO_SIDED|95.0|-389.6|56.6|||ANCOVA|||||56.6|-389.6|0.1412
74045481|NCT00838383|147643067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-199.8||||0.0813|TWO_SIDED|95.0|-425.0|25.5|||ANCOVA|||||25.5|-425.0|0.0813
74045482|NCT00924729|147643086|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74045483|NCT02999191|147643102|OTHER||Ratio|89.9|STANDARD_DEVIATION|36.0|||TWO_SIDED|90.0|73.304|110.25|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fasted (numerator) and Solution, fasted (denominator). The Standard Deviation \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.25|73.304|
74045484|NCT02999191|147643102|OTHER||Ratio|170.78|STANDARD_DEVIATION|33.9|||TWO_SIDED|90.0|139.85|208.54|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fed (numerator) and Tablets, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||208.54|139.85|
74045485|NCT02999191|147643103|OTHER||Ratio|84.17|STANDARD_DEVIATION|48.8|||TWO_SIDED|90.0|64.26|110.24|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fasted (numerator) and Solution, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.24|64.260|
74045486|NCT02999191|147643103|OTHER||Ratio|136.16|STANDARD_DEVIATION|54.8|||TWO_SIDED|90.0|99.885|185.61|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fed (numerator) and Tablets, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||185.61|99.885|
74045487|NCT02896192|147643108|OTHER||CI||||<|0.0001||||||One-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest would achieve 10% weight loss.|Exact binomial test|||||||<0.0001
74045488|NCT02896192|147643109|OTHER||||||<|0.0001||||||One-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest would achieve 10% weight loss.|Exact binomial test|||||||<0.0001
74045489|NCT02896192|147643110|OTHER||Least Squares Mean|-25.73|||<|0.0001|TWO_SIDED|90.0|-28.49|-22.98|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline body weight and random effect for participant, one sided p-value from model.||-22.98|-28.49|<0.0001
74045490|NCT02896192|147643111|OTHER||Least Squares Mean|-27.77||||0.0005|TWO_SIDED|90.0|-40.58|-14.96|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline daily hunger score and random effect for participant, one sided p-value from model.||-14.96|-40.58|0.0005
73880366|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.04||||0.154|TWO_SIDED|95.0|0.76|5.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.47|0.76|0.1540
73880367|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.84||||0.0065|TWO_SIDED|95.0|1.46|10.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.12|1.46|0.0065
73880368|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0052|TWO_SIDED|95.0|1.5|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.14|1.50|0.0052
73880369|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.68||||0.0064|TWO_SIDED|95.0|1.44|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.39|1.44|0.0064
73880370|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0003|TWO_SIDED|95.0|2.26|15.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.21|2.26|0.0003
74095729|NCT00593736|147741376|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.365
74095730|NCT00593736|147741376|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.121
73880371|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0001|TWO_SIDED|95.0|2.47|16.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.69|2.47|0.0001
73880372|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|8.21|||<|0.0001|TWO_SIDED|95.0|3.01|22.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||22.42|3.01|<0.0001
74016384|NCT00511355|147584536|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9662||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.9662
74016385|NCT00511355|147584537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0004
74095731|NCT00593736|147741376|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.269
73880373|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0171|TWO_SIDED|95.0|1.22|7.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.97|1.22|0.0171
73880374|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|4.38||||0.002|TWO_SIDED|95.0|1.71|11.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.18|1.71|0.0020
73880375|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.97||||0.0034|TWO_SIDED|95.0|1.58|9.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.99|1.58|0.0034
73880376|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0399|TWO_SIDED|95.0|1.05|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.59|1.05|0.0399
74016386|NCT00511355|147584538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0019
74016387|NCT00511355|147584539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9662||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.9662
74016388|NCT00511355|147584540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0187||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0187
74016389|NCT00511355|147584541|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
74016390|NCT00511355|147584542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6886||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.6886
74016391|NCT00511355|147584543|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
74016392|NCT00511355|147584544|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
74095732|NCT00593736|147741377|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.920
74095733|NCT00593736|147741377|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.382
74095734|NCT00593736|147741377|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.439
74016393|NCT00511355|147584545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0083||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0083
74016394|NCT00511355|147584546|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0455||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0455
74016395|NCT00511355|147584547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0063
74016396|NCT00511355|147584548|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
74016397|NCT00511355|147584549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
74016398|NCT00511355|147584550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0078
74016399|NCT00511355|147584551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0016
74016400|NCT00511355|147584552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0003
74016401|NCT00511355|147584553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0009
74016402|NCT00511355|147584554|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0024
74016403|NCT00511355|147584555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3653||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.3653
74016404|NCT00511355|147584556|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
74016405|NCT00511355|147584557|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
74016406|NCT00511355|147584558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5668||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.5668
74016407|NCT00511355|147584559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.1770
74016408|NCT00511355|147584560|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
74016409|NCT04770779|147584578|SUPERIORITY||Common Risk Difference on Response Rate|17.6||||0.0003|TWO_SIDED|95.0|8.0|27.2|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||27.2|8.0|0.0003
74016410|NCT04770779|147584579|SUPERIORITY||Common Risk Difference on Response Rate|11.1||||0.0003|TWO_SIDED|95.0|5.1|17.0|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||17.0|5.1|0.0003
74016411|NCT04770779|147584580|SUPERIORITY||Common Risk Difference on Response Rate|13.4|||<|0.0001|TWO_SIDED|95.0|7.7|19.1|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||19.1|7.7|<0.0001
74016412|NCT04770779|147584581|SUPERIORITY||Common Risk Difference on Response Rate|6.4||||0.0056|TWO_SIDED|95.0|1.9|10.9|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||10.9|1.9|0.0056
74016413|NCT03692052|147584598|OTHER||||||<|0.0001|||||||Clopper-Pearson Method|Significance of p-value associated with the test of H0:Hb response rate =0.3 vs H1:Hb response rate \> 0.3.||||||<.0001
74016414|NCT05600309|147584619|OTHER||Hazard Ratio (HR)|0.94||||0.3914|TWO_SIDED|95.0|0.59|1.5||One-sided nominal p-value based on log-rank test.|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.50|0.59|0.3914
74016415|NCT05600309|147584620|OTHER||Hazard Ratio (HR)|1.23||||0.8091|TWO_SIDED|95.0|0.78|1.92||One-sided nominal p-value based on log-rank test.|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.92|0.78|0.8091
74045491|NCT02896192|147643112|OTHER|||||||0.0004||||||One-sided p-value obtained from exact binomial test, testing that ≥ 5% of participants in the population of interest would achieve ≥ 25% improvement in daily hunger score.|Exact binomial test|||||||0.0004
74045492|NCT02896192|147643113|OTHER||Least Squares Mean|-18.1|||<|0.0001|TWO_SIDED|90.0|-21.27|-14.88|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline waist circumference and random effect for participant, one sided p-value from model.||-14.88|-21.27|<0.0001
74095735|NCT00593736|147741378|SUPERIORITY_OR_OTHER|||||||0.973||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.973
74095736|NCT00593736|147741378|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.117
74095737|NCT00593736|147741378|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.816
74016416|NCT05600309|147584621|OTHER||Difference in percentage|6.0||||0.0502|TWO_SIDED|95.0|-2.3|16.3||One-sided nominal p-value for testing.|Miettinen & Nurminen Method||Difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|||16.3|-2.3|0.0502
74016417|NCT04209855|147584689|SUPERIORITY||Cox Proportional Hazard|0.63|||<|0.0001|TWO_SIDED|95.0|0.513|0.785|||Log Rank|||||0.785|0.513|<0.0001
74016418|NCT01250379|147584711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0204|TWO_SIDED|95.0|0.65|0.97|||Log Rank||The 95% confidence interval (CI) was estimated using Cox proportional hazards methodology. The stratification factors used in the analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and lactate dehydrogenase (LDH) level.|||0.97|0.65|0.0204
74016419|NCT01250379|147584711|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0245|TWO_SIDED|95.0|0.67|0.97|||Log Rank||Unstratified analysis.|||0.97|0.67|0.0245
74016420|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.0088|TWO_SIDED|95.0|0.4|0.88|||Log Rank|||Subgroup analysis: HR-neg||0.88|0.40|0.0088
74016421|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.1196|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||Subgroup analysis: HR-pos/HER-neg||1.05|0.67|0.1196
74016422|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.011|TWO_SIDED|95.0|0.43|0.9|||Log Rank|||Subgroup analysis: PFS \<6 months||0.90|0.43|0.0110
74016423|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0816|TWO_SIDED|95.0|0.65|1.03|||Log Rank|||Subgroup analysis: PFS ≥6 months||1.03|0.65|0.0816
74016424|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.0395|TWO_SIDED|95.0|0.31|0.98|||Log Rank|||Subgroup analysis: taxane chemo||0.98|0.31|0.0395
74016425|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.1385|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||Subgroup analysis: non-taxane chemo||1.06|0.68|0.1385
74016426|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.0029|TWO_SIDED|95.0|0.22|0.75|||Log Rank|||Subgroup analysis: vinorelbine chemo||0.75|0.22|0.0029
74016427|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0171|TWO_SIDED|95.0|0.62|0.96|||Log Rank|||Subgroup analysis: LDH ≤ 1.5 ULN||0.96|0.62|0.0171
74045493|NCT02896192|147643116|OTHER||Least Squares Mean|-27.4|||<|0.0001|TWO_SIDED|90.0|-30.6|-24.29|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline BMI and random effect for participant, one sided p-value from model.||-24.29|-30.60|<0.0001
74045494|NCT02448914|147643147|NON_INFERIORITY_OR_EQUIVALENCE|Analysis was first to attempt to show non-inferiority. To show non-inferiority of TRIGEL over Duodopa, the lower limit of the two-sided CI for the treatment ratio had to be above the chosen non-inferiority margin of 0.9. If non-inferiority was shown, analysis continued with test of superiority. To show superiority of TRIGEL versus Duodopa, the lower confidence limit had to be above 1 (corresponding to a p-value less than 0.05).|back-transformed ratio|1.382|||<|0.0001|TWO_SIDED|95.0|1.264|1.511|||ANCOVA|||Levodopa AUC 0-14h/dose, was derived using the trapezoidal method and divided by the total administered dose of levodopa during the corresponding time interval.The primary endpoint was log transformed and analysed using an ANCOVA, adjusting for treatment, period and patient. The back-transformed ratio of TRIGEL over Duodopa was calculated together with 95% confidence intervals (CI) and the associated (2 sided) p value.||1.511|1.264|<0.0001
74016428|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1797|TWO_SIDED|95.0|0.46|1.16|||Log Rank|||Subgroup analysis: LDH \> 1.5 ULN||1.16|0.46|0.1797
74095738|NCT00593736|147741379|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.661
74095739|NCT00593736|147741379|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.341
74016429|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0229|TWO_SIDED|95.0|0.62|0.97|||Log Rank|||Subgroup analysis: \< 65 years of age||0.97|0.62|0.0229
74016430|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.2139|TWO_SIDED|95.0|0.51|1.16|||Log Rank|||Subgroup analysis: ≥ 65 years of age||1.16|0.51|0.2139
74095740|NCT00593736|147741379|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.853
74016431|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0021|TWO_SIDED|95.0|0.59|0.89|||Log Rank|||Subgroup analysis: \< 70 years of age||0.89|0.59|0.0021
74016432|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.5216|TWO_SIDED|95.0|0.64|2.39|||Log Rank|||Subgroup analysis: ≥ 70 years of age||2.39|0.64|0.5216
74016433|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0148|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||Subgroup analysis: \< 3 metastatic organ sites||0.94|0.58|0.0148
74016434|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3102|TWO_SIDED|95.0|0.61|1.17|||Log Rank|||Subgroup analysis: ≥ 3 metastatic organ sites||1.17|0.61|0.3102
74016435|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0967|TWO_SIDED|95.0|0.64|1.04|||Log Rank|||Subgroup analysis: B-free ≤ 6 weeks||1.04|0.64|0.0967
74016436|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.0489|TWO_SIDED|95.0|0.51|1.0|||Log Rank|||Subgroup analysis: B-free \> 6 weeks||1.00|0.51|0.0489
74016437|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0176|TWO_SIDED|95.0|0.41|0.92|||Log Rank|||Subgroup analysis: D-free ≤ 24 months||0.92|0.41|0.0176
74016438|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2318|TWO_SIDED|95.0|0.66|1.11|||Log Rank|||Subgroup analysis: D-free \> 24 months||1.11|0.66|0.2318
74016439|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0568|TWO_SIDED|95.0|0.26|1.03|||Log Rank|||Subgroup analysis: D-free ≤ 12 months||1.03|0.26|0.0568
74016440|NCT01250379|147584712|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1143|TWO_SIDED|95.0|0.66|1.05|||Log Rank|||Subgroup analysis: D-free \> 12 months||1.05|0.66|0.1143
74016441|NCT01250379|147584713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.3457|TWO_SIDED|95.0|-4.2|12.4|||Chi-squared||The 95% CI was estimated using Hauck-Anderson methodology.|||12.4|-4.2|0.3457
74016442|NCT01250379|147584715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9825|TWO_SIDED|95.0|0.51|1.99|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.99|0.51|0.9825
74016443|NCT01250379|147584715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.3601|TWO_SIDED|95.0|0.73|2.34|||Log Rank||Unstratified analysis.|||2.34|0.73|0.3601
74016444|NCT01250379|147584718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.108|TWO_SIDED|95.0|0.59|1.06|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.06|0.59|0.1080
74016445|NCT01250379|147584718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0625|TWO_SIDED|95.0|0.59|1.02|||Log Rank||Unstratified analysis.|||1.02|0.59|0.0625
74016446|NCT01250379|147584720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1349|TWO_SIDED|95.0|0.68|1.05|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.05|0.68|0.1349
74016447|NCT01250379|147584720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0863|TWO_SIDED|95.0|0.68|1.03|||Log Rank||Unstratified analysis.|||1.03|0.68|0.0863
74016448|NCT01250379|147584722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0744|TWO_SIDED|95.0|0.65|1.02|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.02|0.65|0.0744
74016449|NCT01250379|147584722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0503|TWO_SIDED|95.0|0.66|1.0|||Log Rank||Unstratified analysis.|||1.00|0.66|0.0503
74016450|NCT01250379|147584725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.7253|TWO_SIDED|95.0|0.76|1.21|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.21|0.76|0.7253
74016451|NCT01250379|147584725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5332|TWO_SIDED|95.0|0.75|1.16|||Log Rank||Unstratified analysis.|||1.16|0.75|0.5332
74016452|NCT00644787|147584740|NON_INFERIORITY_OR_EQUIVALENCE|Difference of 7.5 mm in VAS score was selected as the threshold value for clinical non-inferiority of Fentanyl 1-day transdermal patch to Fentanyl 3-day transdermal patch.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-3.5|6.23||||||||6.23|-3.50|
74045495|NCT00560794|147643153|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The null hypothesis stated that the true MRD response probability (π) ≤ 5%.|1-sided exact binomial test|||||||0.0000
74045496|NCT04857892|147643167|OTHER||Ratio of geometric Least Square mean|1.025|||||TWO_SIDED|90.0|0.9335|1.126|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.126|0.9335|
73880377|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|5.76||||0.0003|TWO_SIDED|95.0|2.23|14.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.84|2.23|0.0003
73880378|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|4.05||||0.0031|TWO_SIDED|95.0|1.6|10.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.23|1.60|0.0031
73880379|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|3.41|28.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||28.28|3.41|<0.0001
73880380|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0036|TWO_SIDED|95.0|1.57|10.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.01|1.57|0.0036
73880381|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|4.79||||0.0009|TWO_SIDED|95.0|1.89|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||12.11|1.89|0.0009
73880382|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0091|TWO_SIDED|95.0|1.35|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.21|1.35|0.0091
74016453|NCT01327157|147584761|EQUIVALENCE|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors.|Mean Difference (Net)|0.5||||0.524|TWO_SIDED|||||Statistical significance was considered for values of p \<0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results.|t-test, 1 sided|The comparison between the groups in each study period (initial) was done through the t-test for two independent samples.||"We assessed the quality of oral functions in the first query to check the status of discomfort before treatment in both groups, using VAS..~Statistical significance was considered for values of p \<0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results"||||0.524
74016454|NCT01327157|147584762|EQUIVALENCE|"Only the treatment group was analysed. The dental contacts were evaluated in models and gnathostats demarcated after the points were counted in the models before and after treatment If an increase in the number of dental contacts after occlusal adjustment was detected, in relation of the models.~The models are made in the first and last query, after four visits with one month interval between them."|Mean Difference (Net)|5.0|STANDARD_DEVIATION|3.92|<|0.001|TWO_SIDED||||||t-test, 2 sided|||The brand carbon mark was done on the treatment group in the first and last query.||||<0.001
74016455|NCT01327157|147584763|EQUIVALENCE|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors. The comparison among the groups, in each period of the study (initial and final) was done through t test for two independent samples.|Mean Difference (Net)|2.4|STANDARD_DEVIATION|1.44||0.002|TWO_SIDED||||||t-test, 2 sided|||"We assessed the quality of oral functions in the last query to check the status of discomfort after ninety days in both groups, control and treatment, using VAS.~The statistical significance was considered to p\<0.05 values and it was used the Minitab statistics software, 15.1 version, to get the results."||||0.002
74016456|NCT01327157|147584764|OTHER|||||||0.705|||||||t-test, 1 sided|||||||0.705
74095741|NCT00593736|147741380|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.365
74095742|NCT00593736|147741380|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.121
73880383|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.78||||0.2043|TWO_SIDED|95.0|0.73|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.34|0.73|0.2043
73880384|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|4.7||||0.0012|TWO_SIDED|95.0|1.84|12.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||12.01|1.84|0.0012
73880385|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0058|TWO_SIDED|95.0|1.47|9.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.70|1.47|0.0058
73880386|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|8.07||||0.0002|TWO_SIDED|95.0|2.73|23.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||23.83|2.73|0.0002
73880387|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0221|TWO_SIDED|95.0|1.16|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.12|1.16|0.0221
74016457|NCT01327157|147584765|OTHER|||||||0.01|||||||t-test, 1 sided|||||||0.01
74016458|NCT01790503|147584786|OTHER||Hazard Ratio (HR)|0.98||||0.456|TWO_SIDED|95.0|0.71|1.36|||Log Rank|||||1.36|0.71|0.456
74016459|NCT01790503|147584786|OTHER||Hazard Ratio (HR)|1.05||||0.619|TWO_SIDED|95.0|0.77|1.43|||Log Rank|||||1.43|0.77|0.619
74016460|NCT01790503|147584786|OTHER||Hazard Ratio (HR)|0.9||||0.272|TWO_SIDED|95.0|0.65|1.26|||Log Rank|||||1.26|0.65|0.272
74016461|NCT01790503|147584787|OTHER|||||||0.44|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.440
74016462|NCT01790503|147584787|OTHER|||||||0.699|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||0.699
74016463|NCT01790503|147584787|OTHER|||||||0.003|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||0.003
74016464|NCT01790503|147584787|OTHER|||||||0.201|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.201
73880388|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0034|TWO_SIDED|95.0|1.58|10.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.13|1.58|0.0034
74016465|NCT01790503|147584789|OTHER||Hazard Ratio (HR)|0.94||||0.389|TWO_SIDED|95.0|0.6|1.47|||Log Rank|||||1.47|0.60|0.389
74016466|NCT01790503|147584789|OTHER||Hazard Ratio (HR)|0.94||||0.393|TWO_SIDED|95.0|0.63|1.42|||Log Rank|||||1.42|0.63|0.393
74016467|NCT01790503|147584789|OTHER||Hazard Ratio (HR)|0.98||||0.469|TWO_SIDED|95.0|0.63|1.54|||Log Rank|||||1.54|0.63|0.469
74016468|NCT01790503|147584790|OTHER|||||||0.063|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.063
74016469|NCT01790503|147584790|OTHER|||||||0.969|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||0.969
74016470|NCT01790503|147584790|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||<0.001
74016471|NCT01790503|147584790|OTHER|||||||0.501|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.501
74016472|NCT01790503|147584791|OTHER|||||||0.705|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.705
74016473|NCT01790503|147584791|OTHER||||||>|0.999|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||>0.999
74016474|NCT01790503|147584791|OTHER|||||||0.099|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||0.099
74016475|NCT01790503|147584791|OTHER|||||||0.348|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.348
74016476|NCT02762513|147584816|OTHER||Median overall survival time (months)|9.8|||||TWO_SIDED|95.0|||||||Median calculated by Kaplan-Meier method.|||||
74016477|NCT02762513|147584817|OTHER||Median PFS time (months)|3.5|||||TWO_SIDED|95.0|||||||Median calculated by Kaplan-Meier method.|||||
74016478|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|849.0|||<|0.0001|TWO_SIDED|95.0|786.0|921.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||921|786|<0.0001
74016479|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1879.0|||<|0.0001|TWO_SIDED|95.0|1636.0|2112.0||Adjusted Cost Differences in Prescription Drug Costs, nonAEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||2112|1636|<0.0001
74016480|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5681.0|||<|0.0001|TWO_SIDED|95.0|5257.0|6077.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||6077|5257|<0.0001
74016481|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|273.0|||<|0.0001|TWO_SIDED|95.0|251.0|295.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||295|251|<0.0001
74016482|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1021.0|||<|0.0001|TWO_SIDED|95.0|819.0|1211.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||1211|819|<0.0001
74016483|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|60.0|||<|0.0001|TWO_SIDED|95.0|48.0|72.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||72|48|<0.0001
74016484|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2555.0||||0.008|TWO_SIDED|95.0|834.0|4281.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||4281|834|0.0080
74045497|NCT04857892|147643167|OTHER||Ratio of geometric Least Square mean|1.072|||||TWO_SIDED|90.0|0.9693|1.185|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.185|0.9693|
74045498|NCT04857892|147643168|OTHER||Ratio of geometric Least Square mean|1.126|||||TWO_SIDED|90.0|0.9918|1.278|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.278|0.9918|
73880389|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0123|TWO_SIDED|95.0|1.29|8.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.04|1.29|0.0123
73880390|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.56||||0.3291|TWO_SIDED|95.0|0.64|3.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.78|0.64|0.3291
73880391|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0118|TWO_SIDED|95.0|1.3|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.21|1.30|0.0118
74016485|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4041.0|||<|0.0001|TWO_SIDED|95.0|3776.0|4305.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||4305|3776|<0.0001
74016486|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|105.0|||<|0.0001|TWO_SIDED|95.0|97.0|114.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||114|97|<0.0001
74016487|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|384.0|||<|0.0001|TWO_SIDED|95.0|358.0|413.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||413|358|<0.0001
74016488|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.0|||<|0.0001|TWO_SIDED|95.0|40.0|56.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||56|40|<0.0001
74016489|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|892.0|||<|0.0001|TWO_SIDED|95.0|584.0|1192.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||1192|584|<0.0001
74016490|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12258.0|||<|0.0001|TWO_SIDED|95.0|10482.0|14083.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||14083|10482|<0.0001
74016491|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|322.0|||<|0.0001|TWO_SIDED|95.0|245.0|398.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||398|245|<0.0001
74016492|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|841.0|||<|0.0001|TWO_SIDED|95.0|556.0|1078.0||Adjusted Cost Differences in Prescription Drug Costs, non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1078|556|<0.0001
74016493|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3248.0|||<|0.0001|TWO_SIDED|95.0|2790.0|3714.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||3714|2790|<0.0001
74016494|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|164.0|||<|0.0001|TWO_SIDED|95.0|138.0|190.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||190|138|<0.0001
74016495|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|628.0|||<|0.0001|TWO_SIDED|95.0|409.0|819.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||819|409|<0.0001
74016496|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.0|||<|0.0001|TWO_SIDED|95.0|18.0|42.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||42|18|<0.0001
74016497|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|235.0||||0.7628|TWO_SIDED|95.0|-1367.0|1798.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1798|-1367|0.7628
74016498|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2306.0|||<|0.0001|TWO_SIDED|95.0|2016.0|2603.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||2603|2016|<0.0001
74045499|NCT04857892|147643168|OTHER||Ratio of geometric Least Square mean|1.055|||||TWO_SIDED|90.0|0.9278|1.201|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.201|0.9278|
74016499|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0|||<|0.0001|TWO_SIDED|95.0|52.0|74.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||74|52|<0.0001
74016500|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.0|||<|0.0001|TWO_SIDED|95.0|179.0|245.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||245|179|<0.0001
74016501|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||<|0.0001|TWO_SIDED|95.0|15.0|33.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||33|15|<0.0001
74016502|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|277.0||||0.0581|TWO_SIDED|95.0|-19.0|581.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||581|-19|0.0581
74016503|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5437.0|||<|0.0001|TWO_SIDED|95.0|3672.0|7142.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||7142|3672|<0.0001
74016504|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1019.0|||<|0.0001|TWO_SIDED|95.0|836.0|1191.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1191|836|<0.0001
74016505|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1047.0|||<|0.0001|TWO_SIDED|95.0|564.0|1486.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1486|564|<0.0001
74016506|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|9128.0|||<|0.0001|TWO_SIDED|95.0|7346.0|11125.0||Adjusted Cost Differences in Hospitalizations|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||11125|7346|<0.0001
74045500|NCT04857892|147643169|OTHER||Ratio of geometric Least Square mean|1.036|||||TWO_SIDED|90.0|0.9209|1.166|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax.|||1.166|0.9209|
74045501|NCT04857892|147643169|OTHER||Ratio of geometric Least Square mean|1.02|||||TWO_SIDED|90.0|0.9049|1.151|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax.|||1.151|0.9049|
74045502|NCT04857892|147643170|OTHER||Ratio of geometric Least Square mean|1.129|||||TWO_SIDED|90.0|1.067|1.195|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.195|1.067|
74095743|NCT00593736|147741380|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.268
74095744|NCT00593736|147741381|SUPERIORITY_OR_OTHER|||||||0.9||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.900
74016507|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|459.0|||<|0.0001|TWO_SIDED|95.0|326.0|622.0||Adjusted Cost Differences in Emergency Department Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||622|326|<0.0001
74016508|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2427.0|||<|0.0001|TWO_SIDED|95.0|1587.0|3290.0||Adjusted Cost Differences in Outpatient Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||3290|1587|<0.0001
74045503|NCT04857892|147643170|OTHER||Ratio of geometric Least Square mean|1.112|||||TWO_SIDED|90.0|1.05|1.178|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.178|1.050|
74045504|NCT04857892|147643171|OTHER||Ratio of geometric Least Square mean|1.164|||||TWO_SIDED|90.0|1.07|1.267|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.267|1.070|
74045505|NCT04857892|147643171|OTHER||Ratio of geometric Least Square mean|1.087|||||TWO_SIDED|90.0|0.9975|1.184|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.184|0.9975|
74045506|NCT04857892|147643172|OTHER||Ratio of geometric Least Square mean|1.078|||||TWO_SIDED|90.0|1.036|1.122|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.122|1.036|
74045507|NCT04857892|147643172|OTHER||Ratio of geometric Least Square mean|1.032|||||TWO_SIDED|90.0|0.9914|1.075|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.075|0.9914|
74016509|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|357.0|||<|0.0001|TWO_SIDED|95.0|225.0|525.0||Adjusted Cost Differences in Neurologists Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||525|225|<0.0001
74016510|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|502.0|||<|0.0001|TWO_SIDED|95.0|234.0|768.0||Adjusted Cost Differences in Other Healthcare Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||768|234|<0.0001
74016511|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6483.0|||<|0.0001|TWO_SIDED|95.0|5329.0|7927.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||7927|5329|<0.0001
74016512|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|150.0|||<|0.0001|TWO_SIDED|95.0|112.0|199.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||199|112|<0.0001
74016513|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|516.0|||<|0.0001|TWO_SIDED|95.0|401.0|645.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||645|401|<0.0001
74016514|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|158.0|||<|0.0001|TWO_SIDED|95.0|97.0|231.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||231|97|<0.0001
74016515|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|83.0|||<|0.0001|TWO_SIDED|95.0|58.0|113.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||113|58|<0.0001
74016516|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14582.0|||<|0.0001|TWO_SIDED|95.0|12019.0|17097.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||17097|12019|<0.0001
74016517|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|420.0|||<|0.0001|TWO_SIDED|95.0|210.0|630.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||630|210|<0.0001
74016518|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|658.0|||<|0.0001|TWO_SIDED|95.0|217.0|1131.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1131|217|<0.0001
74016519|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6040.0|||<|0.0001|TWO_SIDED|95.0|3442.0|8795.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||8795|3442|<0.0001
74016520|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|268.0||||0.002|TWO_SIDED|95.0|81.0|425.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||425|81|0.0020
74016521|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.967|TWO_SIDED|95.0|-991.0|944.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||944|-991|0.9670
74016522|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|97.0||||0.2563|TWO_SIDED|95.0|-77.0|302.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||302|-77|0.2563
74016523|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|328.0||||0.01|TWO_SIDED|95.0|90.0|588.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||588|90|0.0100
74016524|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4984.0|||<|0.0001|TWO_SIDED|95.0|3168.0|7335.0||Adjusted Cost Differences in Hospitalizations, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||7335|3168|<0.0001
74016525|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|112.0|||<|0.0001|TWO_SIDED|95.0|70.0|166.0||Adjusted Cost Differences in Emergency Department Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||166|70|<0.0001
74045508|NCT04857892|147643173|OTHER||Ratio of geometric Least Square mean|2.705|||||TWO_SIDED|90.0|2.135|3.427|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf)|||3.427|2.135|
74045509|NCT04857892|147643174|OTHER||Ratio of geometric Least Square mean|2.761|||||TWO_SIDED|90.0|2.16|3.527|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t)|||3.527|2.160|
73880392|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.93||||0.0058|TWO_SIDED|95.0|1.49|10.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.40|1.49|0.0058
74095745|NCT00593736|147741381|SUPERIORITY_OR_OTHER|||||||0.525||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.525
74016526|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|236.0||||0.01|TWO_SIDED|95.0|70.0|403.0||Adjusted Cost Differences in Outpatient Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||403|70|0.01
74016527|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.0||||0.1061|TWO_SIDED|95.0|-22.0|145.0||Adjusted Cost Differences in Neurologist Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||145|-22|0.1061
74016528|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.0|||<|0.0001|TWO_SIDED|95.0|28.0|93.0||Adjusted Cost Differences in Other Healthcare Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||93|28|<0.0001
74016529|NCT01390909|147584822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7673.0|||<|0.0001|TWO_SIDED|95.0|4571.0|10989.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||10989|4571|<0.0001
74016530|NCT03269344|147584832|SUPERIORITY|||||||0.11|||||||ANOVA|||||||0.11
74016531|NCT03269344|147584833|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
74016532|NCT03269344|147584834|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
74016533|NCT03269344|147584835|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74016534|NCT03269344|147584836|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
74045510|NCT04857892|147643175|OTHER||Ratio of geometric Least Square mean|2.498|||||TWO_SIDED|90.0|1.821|3.425|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||3.425|1.821|
74016535|NCT03269344|147584837|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
74016536|NCT02597855|147584840|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||The difference of polyp regression rate between two groups were compared.||||<0.05
74016537|NCT02597855|147584841|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney test was used for a comparison of best corrected visual acuity assessed at baseline, 3 months, and 6 months between type1 and type2.||best corrected visual acuity was compared between two groups||||<0.05
74016538|NCT05022641|147584861|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||.6
74016539|NCT05022641|147584862|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||.65
74016540|NCT05022641|147584863|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||.02
74016541|NCT05022641|147584864|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
74016542|NCT05022641|147584866|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||.6
74016543|NCT02889796|147584867|SUPERIORITY||Difference in Response Rates|26.7|||<|0.001|TWO_SIDED|95.0|20.6|32.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||32.8|20.6|<0.001
74016544|NCT02889796|147584867|SUPERIORITY||Difference in Response Rates|19.9|||<|0.001|TWO_SIDED|95.0|13.6|26.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||26.2|13.6|<0.001
74016545|NCT02889796|147584868|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.36|-0.22||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.22|-0.36|<0.001
74016546|NCT02889796|147584868|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.24|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.10|-0.24|<0.001
74016547|NCT02889796|147584869|SUPERIORITY||Difference in Response Rates|24.8|||<|0.001|TWO_SIDED|95.0|19.6|30.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||30.0|19.6|<0.001
74016548|NCT02889796|147584869|SUPERIORITY||Difference in Response Rates|14.5|||<|0.001|TWO_SIDED|95.0|9.7|19.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||19.3|9.7|<0.001
74045511|NCT04857892|147643176|OTHER||Ratio of geometric Least Square mean|1.316|||||TWO_SIDED|90.0|1.193|1.451|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf)|||1.451|1.193|
74045512|NCT04857892|147643177|OTHER||Ratio of geometric Least Square mean|1.316|||||TWO_SIDED|90.0|1.193|1.452|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t)|||1.452|1.193|
74095746|NCT00593736|147741381|SUPERIORITY_OR_OTHER|||||||0.418||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.418
74095747|NCT00593736|147741382|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.051
73880393|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|5.98||||0.0012|TWO_SIDED|95.0|2.03|17.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||17.65|2.03|0.0012
74095748|NCT00593736|147741382|SUPERIORITY_OR_OTHER|||||||0.926||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.926
74095749|NCT00593736|147741382|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.166
74095750|NCT00593736|147741383|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.511
74095751|NCT00593736|147741383|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.082
74095752|NCT00593736|147741383|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.188
74095753|NCT00593736|147741384|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.691
74095754|NCT00593736|147741384|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.323
74095755|NCT00593736|147741384|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.324
74095756|NCT00593736|147741385|SUPERIORITY_OR_OTHER|||||||0.197||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.197
74095757|NCT00593736|147741385|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.871
74095758|NCT00593736|147741385|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.737
74095759|NCT00593736|147741386|SUPERIORITY_OR_OTHER|||||||0.972||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.972
74095760|NCT00593736|147741386|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.117
74095761|NCT00593736|147741386|SUPERIORITY_OR_OTHER|||||||0.811||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.811
74095762|NCT00593736|147741387|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.659
74095763|NCT00593736|147741387|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.337
74095764|NCT00593736|147741387|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.853
74095765|NCT00593736|147741388|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.206
74095766|NCT00593736|147741388|SUPERIORITY_OR_OTHER|||||||0.495||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.495
74095767|NCT00593736|147741388|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.800
74095768|NCT00593736|147741389|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.194
74095769|NCT00593736|147741389|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.134
74095770|NCT00593736|147741389|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.130
74095771|NCT00593736|147741390|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.063
74095772|NCT00593736|147741390|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.156
74045513|NCT04857892|147643178|OTHER||Ratio of geometric Least Square mean|1.232|||||TWO_SIDED|90.0|1.138|1.333|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.333|1.138|
74045514|NCT00880607|147643302|OTHER|Wilcoxon rank-sum test because the outcome variable was found to have a skewed distribution.|Median Difference (Final Values)|7.7||||0.27|TWO_SIDED|95.0|-5.8|21.2||Hodges-Lehmanne estimation method|Wilcoxon (Mann-Whitney)||Hodges-Lehmanne estimation method|||21.2|-5.8|.27
74095773|NCT00593736|147741390|SUPERIORITY_OR_OTHER|||||||0.521||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.521
74095774|NCT00593736|147741391|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.675
74095775|NCT00593736|147741391|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.566
73880394|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1043|TWO_SIDED|95.0|0.85|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.32|0.85|0.1043
74095776|NCT00593736|147741391|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.205
74095777|NCT00593736|147741392|SUPERIORITY_OR_OTHER|||||||0.643||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.643
74095778|NCT00593736|147741392|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.032
74095779|NCT00593736|147741392|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.875
74095780|NCT00593736|147741393|SUPERIORITY_OR_OTHER|||||||0.286||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.286
74095781|NCT00593736|147741393|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.318
74095782|NCT00593736|147741393|SUPERIORITY_OR_OTHER|||||||0.483||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.483
74095783|NCT00593736|147741394|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.040
74045515|NCT00880607|147643303|OTHER|Log-rank test in Kaplan-Meier used.||||||0.42|TWO_SIDED|95.0|||||Log Rank|||||||.42
74045516|NCT00880607|147643305|OTHER|||||||0.08|||||||Chi-squared|||||||0.08
74045517|NCT00880607|147643306|OTHER|||||||0.3|||||||Chi-squared|||||||0.30
74045518|NCT00880607|147643307|OTHER|||||||0.07|||||||Chi-squared|||||||0.07
74045519|NCT00880607|147643308|OTHER|||||||0.31|||||||Chi-squared|||||||0.31
74045520|NCT02963766|147643311|SUPERIORITY||LS Mean difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.8|-0.7|||Mixed Models Analysis|||||-0.7|-1.8|<0.001
74045521|NCT02963766|147643312|SUPERIORITY||LS Mean difference (Final Values)|-1.0||||0.002|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||||-0.4|-1.7|0.002
74045522|NCT02963766|147643312|SUPERIORITY||LS Mean difference (Final Values)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.2|-0.9|||Mixed Models Analysis|||||-0.9|-2.2|<0.001
74045523|NCT02963766|147643313|SUPERIORITY||LS Mean difference (Final Values)|-1.44||||0.021|TWO_SIDED|95.0|-2.65|-0.22|||Mixed Models Analysis|||||-0.22|-2.65|0.021
74045524|NCT02963766|147643313|SUPERIORITY||LS Mean difference (Final Values)|-2.51|||<|0.001|TWO_SIDED|95.0|-3.72|-1.29|||Mixed Models Analysis|||||-1.29|-3.72|<0.001
73880395|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0015|TWO_SIDED|95.0|1.85|13.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||13.54|1.85|0.0015
73880396|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0658|TWO_SIDED|95.0|0.95|5.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.73|0.95|0.0658
74045525|NCT02963766|147643313|SUPERIORITY||LS Mean difference (Final Values)|-1.97|||<|0.001|TWO_SIDED|95.0|-3.03|-0.91|||Mixed Models Analysis|||||-0.91|-3.03|<0.001
74045526|NCT02963766|147643314|SUPERIORITY||Odds Ratio (OR)|11.038|||<|0.001|TWO_SIDED|95.0|3.491|34.902|||Regression, Logistic|||||34.902|3.491|<0.001
74045527|NCT02963766|147643314|SUPERIORITY||Odds Ratio (OR)|11.666|||<|0.001|TWO_SIDED|95.0|3.653|37.253|||Regression, Logistic|||||37.253|3.653|<0.001
74045528|NCT02963766|147643314|SUPERIORITY||Odds Ratio (OR)|11.348|||<|0.001|TWO_SIDED|95.0|4.163|30.932|||Regression, Logistic|||||30.932|4.163|<0.001
74045529|NCT02963766|147643315|SUPERIORITY||LS Mean difference (Final Values)|-0.1||||0.689|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.689
74045530|NCT02963766|147643315|SUPERIORITY||LS Mean difference (Final Values)|0.0||||0.924|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||||0.5|-0.6|0.924
74045531|NCT02963766|147643315|SUPERIORITY||LS Mean difference (Final Values)|-0.1||||0.776|TWO_SIDED|95.0|-0.6|0.4|||Mixed Models Analysis|||||0.4|-0.6|0.776
74045532|NCT02527564|147643357|OTHER|||||||0.1||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Within group change at week 1 - suvorexant (double-blind)||||0.10
74045533|NCT02527564|147643357|OTHER|||||||0.57||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Within group change at week 1- placebo (double-blind) group||||0.57
74045534|NCT02527564|147643357|OTHER|||||||0.44||||||A p-value of \<0.05 would be considered statistically significant.|Unpaired 2-sided t-test|||Between group change at week 1||||0.44
74045535|NCT02527564|147643358|OTHER|||||||0.035||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at week 1 - suvorexant (double-blind)||||0.035
74045536|NCT02527564|147643358|OTHER|||||||0.55|||||||Paired 2-sided t-test|A p-value of \<0.05 would be considered statistically significant.||Within group change at week 1- placebo (double-blind) group||||0.55
74045537|NCT02527564|147643358|OTHER|||||||0.89||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Between group change at week 1||||0.89
74045538|NCT02527564|147643359|OTHER|||||||0.97||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at month 3 - suvorexant (open-label)||||0.97
74045539|NCT02527564|147643360|OTHER|||||||0.28||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at month 3 - suvorexant (open-label)||||0.28
74045540|NCT00420342|147643361|SUPERIORITY_OR_OTHER|||||||0.1182||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.1182
74045541|NCT00420342|147643361|SUPERIORITY_OR_OTHER|||||||0.2224||95.0||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.2224
74045542|NCT00420342|147643361|SUPERIORITY_OR_OTHER|||||||0.6929||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.6929
74045543|NCT00420342|147643362|SUPERIORITY_OR_OTHER|||||||0.0702||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.0702
74045544|NCT00420342|147643362|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.1980
74095784|NCT00593736|147741394|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.610
74095785|NCT00593736|147741394|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.368
74095786|NCT00593736|147741395|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.352
74045545|NCT00420342|147643362|SUPERIORITY_OR_OTHER|||||||0.5777||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.5777
74045546|NCT02473289|147643378|SUPERIORITY||Difference of Least Square (LS) Means|-0.8|STANDARD_ERROR_OF_MEAN|1.67||0.31|TWO_SIDED|75.0|-2.77|1.1||1-sided|MMRM|Here 'MMRM' refers to Mixed-effect Model Using Repeated Measures.||||1.10|-2.77|0.310
74045547|NCT03285490|147643400|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 complete clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
74045548|NCT03285490|147643401|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%.|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 partial clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
74045549|NCT01291511|147643425|SUPERIORITY||Cox Proportional Hazard|5.2|||<|0.0001|TWO_SIDED|95.0|3.2|8.4|||Log Rank|||||8.4|3.2|<0.0001
74045550|NCT01291511|147643426|SUPERIORITY||||||<|0.0001||||||P-value is based on an ANCOVA model with treatment and site as main effects and DBRP baseline as a covariate.|ANCOVA|||||||<0.0001
74045551|NCT01291511|147643428|SUPERIORITY|||||||0.0062||||||P-value is based on an ANCOVA model with treatment and site as main effects and DBRP baseline as a covariate.|ANCOVA|||||||0.0062
74045552|NCT02565576|147643436|SUPERIORITY||estimate of contrast posterior median|-1.14|||||TWO_SIDED|90.0|-3.41|1.14|||bayesian|||Primary analysis was performed on the PD analysis set. Changes from baseline in QMG scores at Week 25 were analyzed using a Bayesian model. The model investigated effects for treatment (CFZ533 or placebo) and baseline QMG score. A difference of 3 points on the mean change in QMG score between CFZ533 and placebo was deemed a clinical meaningful effect.||1.14|-3.41|
74045553|NCT02918318|147643447|SUPERIORITY||Difference of Least Squares means|-1.0|STANDARD_ERROR_OF_MEAN|2.25||0.475|TWO_SIDED|90.0|-5.77|3.7||1-sided|Dunnett adjustment|||||3.70|-5.77|0.475
74045554|NCT02918318|147643447|SUPERIORITY||Difference of Least Squares means|0.6|STANDARD_ERROR_OF_MEAN|2.33||0.504|TWO_SIDED|90.0|-4.32|5.47||1-sided|Dunnett adjustment|||||5.47|-4.32|0.504
74045555|NCT02918318|147643447|SUPERIORITY||Difference of Least Squares means|-0.9|STANDARD_ERROR_OF_MEAN|2.26||0.482|TWO_SIDED|90.0|-5.66|3.83||1-sided|Dunnett adjustment|||||3.83|-5.66|0.482
74045556|NCT03185819|147643486|SUPERIORITY||Difference of LS Means|-5.8|STANDARD_ERROR_OF_MEAN|2.74|=|0.037|TWO_SIDED|95.0|-11.19|-0.35||Threshold for significance for p-value was 0.05.|ANCOVA|||A pooled (54 mg and 84 mg) sequential multiple testing procedure was implemented to control type I error by comparing pooled data against midazolam + placebo matched to esketamine nasal spray.||-0.35|-11.19|= 0.037
74045557|NCT03185819|147643486|SUPERIORITY||Difference of LS Mean|-5.7|STANDARD_ERROR_OF_MEAN|3.65|=|0.123|TWO_SIDED|95.0|-12.91|1.55||Threshold for significance for p-value was 0.05.|ANCOVA|||Individual esketamine dose (84 mg versus medazolam + esketamine matched placebo) independent testing was planned to be performed after pooled (56 mg + 84 mg) analysis.||1.55|-12.91|= 0.123
74045558|NCT03185819|147643486|SUPERIORITY||Difference of LS Means|-5.9|STANDARD_ERROR_OF_MEAN|3.23|=|0.072|TWO_SIDED|95.0|-12.25|0.53||Threshold for significance for p-value was 0.05.|ANCOVA|||Individual esketamine dose (56 mg versus medazolam + esketamine matched placebo) independent testing was planned to be performed after pooled (56 mg + 84 mg) analysis.||0.53|-12.25|= 0.072
74095787|NCT00593736|147741395|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.860
74045559|NCT03185819|147643486|SUPERIORITY||Difference of LS Means|-2.4|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|-9.08|4.19||||||||4.19|-9.08|
74045560|NCT02910089|147643507|SUPERIORITY|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.2|0.32||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with an identity link function (as a continuous variable) and normally distributed errors|Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics|||0.32|-0.2|
74045561|NCT02910089|147643508|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.42|4.4||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with an identity link function and normally distributed errors|Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics|Average of the percentage (proportion x 100) of days covered across all subjects.||4.40|-2.42|
74045562|NCT02910089|147643509|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.83|1.28||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with a logit link and binary distributed errors||||1.28|0.83|
74045563|NCT02910089|147643510|OTHER|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.71|1.17||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|See comments|Generalized Estimating Equations with a logit link and binary distributed errors||||1.17|0.71|
74045564|NCT01872897|147643560|SUPERIORITY||Mean Difference (Final Values)|-9.79||||0.0003|TWO_SIDED|95.0|-14.85|-4.74|||Mixed Models Analysis|||||-4.74|-14.85|0.0003
74045565|NCT01872897|147643561|SUPERIORITY||Mean Difference (Final Values)|-15.76|||<|0.0001|TWO_SIDED|95.0|-22.82|-8.71|||Mixed Models Analysis|||||-8.71|-22.82|<0.0001
74045566|NCT01872897|147643562|SUPERIORITY||Median Difference (Final Values)|-19.4||||0.0004|TWO_SIDED|95.0|-29.6|-9.2|||Mixed Models Analysis|||||-9.2|-29.6|0.0004
74016549|NCT02889796|147584869|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 using non-responder imputation (NRI).|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 12.||||<0.001
74016550|NCT02889796|147584869|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 using NRI.||||||0.002||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 12.||||0.002
74016551|NCT02889796|147584869|SUPERIORITY||Difference in Response Rates|10.4||||0.001|TWO_SIDED|95.0|3.9|17.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 12.||17.0|3.9|0.001
74016552|NCT02889796|147584869|SUPERIORITY||Difference in Response Rates|0.1||||0.99|TWO_SIDED|95.0|-6.2|6.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 12.||6.3|-6.2|0.99
74016553|NCT02889796|147584870|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.43|<0.001
74016554|NCT02889796|147584870|SUPERIORITY||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.078||0.001|TWO_SIDED|95.0|-0.4|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.10|-0.40|0.001
74016555|NCT02889796|147584871|SUPERIORITY||Difference in Response Rates|26.3|||<|0.001|TWO_SIDED|95.0|20.2|32.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||32.4|20.2|<0.001
74045567|NCT01872897|147643563|SUPERIORITY||Mean Difference (Final Values)|-16.3||||0.0019|TWO_SIDED|95.0|-26.2|-6.4|||Mixed Models Analysis|||||-6.4|-26.2|0.0019
74045568|NCT01872897|147643564|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.029|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis|||||-0.1|-1.6|0.0290
74045569|NCT01872897|147643565|SUPERIORITY||Mean Difference (Final Values)|-14.4|||<|0.0001|TWO_SIDED|95.0|-20.57|-8.23|||Mixed Models Analysis|||||-8.23|-20.57|<0.0001
74016556|NCT02889796|147584871|SUPERIORITY||Difference in Response Rates|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||21.4|9.4|<0.001
74016557|NCT02889796|147584871|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 12||||<0.001
74016558|NCT02889796|147584871|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.||||||0.054||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 12||||0.054
74016559|NCT02889796|147584871|SUPERIORITY||Difference in Response Rates|6.3||||0.069|TWO_SIDED|95.0|-1.0|13.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 12||13.6|-1.0|0.069
74016560|NCT02889796|147584871|SUPERIORITY||Difference in Response Rates|-4.6||||0.18|TWO_SIDED|95.0|-11.8|2.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 12||2.6|-11.8|0.18
74016561|NCT02889796|147584872|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|2.8|4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.6|2.8|<0.001
74016562|NCT02889796|147584872|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|2.2|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|2.2|<0.001
74016563|NCT02889796|147584873|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|1.7|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.7|<0.001
74045570|NCT01872897|147643566|SUPERIORITY||Mean Difference (Final Values)|-23.37|||<|0.0001|TWO_SIDED|95.0|-31.55|-15.19|||Mixed Models Analysis|||||-15.19|-31.55|<0.0001
74045571|NCT01872897|147643567|SUPERIORITY||Mean Difference (Final Values)|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.6|||Mixed Models Analysis|||||-4.6|-10.0|<0.0001
74045572|NCT01872897|147643568|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.0001|TWO_SIDED|95.0|-9.4|-3.3|||Mixed Models Analysis|||||-3.3|-9.4|0.0001
74045573|NCT01872897|147643569|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.0075|TWO_SIDED|95.0|-10.9|-1.8|||Mixed Models Analysis|||||-1.8|-10.9|0.0075
74045574|NCT01872897|147643570|SUPERIORITY||Mean Difference (Final Values)|-24.145||||0.0007|TWO_SIDED|95.0|-37.432|-10.858|||Mixed Models Analysis|||||-10.858|-37.432|0.0007
74045575|NCT04254796|147643571|OTHER|Calculation of the effect size (Cohen's d)|Cohen's d|0.27|||||TWO_SIDED|95.0|-0.13|0.68||||||The goal of the analysis was to measure the effect size of the change in the primary mechanistic outcome (Putamen structural node strength), with a Go/No-Go threshold of Cohen's d \> 0.20.||0.68|-0.13|
74045576|NCT04159701|147643573|SUPERIORITY||Mean Difference (Final Values)|2.94||||0.38|TWO_SIDED|95.0|-3.73|9.6|||Mixed Models Analysis|||||9.60|-3.73|0.380
74045577|NCT04159701|147643574|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.415|TWO_SIDED|95.0|-1.89|4.5|||Mixed Models Analysis|||||4.50|-1.89|0.415
74045578|NCT04159701|147643575|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.369|TWO_SIDED|95.0|-2.09|5.53|||Mixed Models Analysis|||||5.53|-2.09|0.369
74045579|NCT04159701|147643576|SUPERIORITY||Odds Ratio (OR)|0.61||||0.674|TWO_SIDED|95.0|0.14|2.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (\< 28 vs \>= 28) score.||||2.70|0.14|0.674
74045580|NCT04159701|147643577|SUPERIORITY||Odds Ratio (OR)|0.59||||0.674|TWO_SIDED|95.0|0.13|2.68|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (\< median vs \>= median) score.||||2.68|0.13|0.674
74045581|NCT03605836|147643580|SUPERIORITY||Least Squares (LS) Mean Difference|-4.01|||=|0.0021|TWO_SIDED|95.0|-6.55|-1.46|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-1.46|-6.55|=0.0021
74045582|NCT03605836|147643580|SUPERIORITY||LS Mean Difference|-4.42|||=|0.0009|TWO_SIDED|95.0|-7.02|-1.82|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-1.82|-7.02|=0.0009
74045583|NCT03605836|147643581|SUPERIORITY||LS Mean Difference|-0.33|||=|0.0073|TWO_SIDED|95.0|-0.57|-0.09|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-0.09|-0.57|=0.0073
74045584|NCT03605836|147643581|SUPERIORITY||LS Mean Difference|-0.28|||=|0.0245|TWO_SIDED|95.0|-0.53|-0.04|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-0.04|-0.53|=0.0245
74045585|NCT02845440|147643586|SUPERIORITY||Odds Ratio (OR)|2.4||||0.013|TWO_SIDED|95.0|1.2|4.79||A priori threshold for significance was p \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||4.79|1.20|0.013
74045586|NCT02845440|147643586|SUPERIORITY||Odds Ratio (OR)|1.31||||0.481|TWO_SIDED|95.0|0.62|2.74||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.74|0.62|0.481
74045587|NCT02845440|147643586|SUPERIORITY||Odds Ratio (OR)|1.84||||0.036|TWO_SIDED|95.0|1.04|3.24||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||3.24|1.04|0.036
74045588|NCT02845440|147643587|SUPERIORITY||Odds Ratio (OR)|1.35||||0.174|TWO_SIDED|95.0|0.88|2.06||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||2.06|0.88|0.174
74045589|NCT02845440|147643587|SUPERIORITY||Odds Ratio (OR)|0.69||||0.092|TWO_SIDED|95.0|0.45|1.06||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||1.06|0.45|0.092
74045590|NCT02845440|147643588|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.61|4.75||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||4.75|1.61|<0.001
74045591|NCT02845440|147643588|SUPERIORITY||Odds Ratio (OR)|0.9||||0.742|TWO_SIDED|95.0|0.5|1.64||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||1.64|0.50|0.742
74045592|NCT02845440|147643589|SUPERIORITY||Odds Ratio (OR)|1.57||||0.056|TWO_SIDED|95.0|0.99|2.51||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of TUD medication use on abstinence rates attributable to the AD+CHW intervention was 2.8%.|2.51|0.99|0.056
74045593|NCT02845440|147643590|SUPERIORITY||Odds Ratio (OR)|1.97||||0.012|TWO_SIDED|95.0|1.16|3.33||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as varenicline use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of varenicline use on abstinence rates attributable to the AD+CHW intervention was 13.9%.|3.33|1.16|0.012
73880397|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1253|TWO_SIDED|95.0|0.82|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.98|0.82|0.1253
73880398|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0013|TWO_SIDED|95.0|1.88|13.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||13.34|1.88|0.0013
74016564|NCT02889796|147584873|SUPERIORITY||Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.5|3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.7|1.5|<0.001
74016565|NCT02889796|147584874|SUPERIORITY||Difference in Response Rates|8.0|||<|0.001|TWO_SIDED|95.0|5.1|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||10.9|5.1|<0.001
74016566|NCT02889796|147584874|SUPERIORITY||Difference in Response Rates|4.8|||<|0.001|TWO_SIDED|95.0|2.3|7.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||7.3|2.3|<0.001
74016567|NCT02889796|147584874|SUPERIORITY||Difference in Response Rates|16.4|||<|0.001|TWO_SIDED|95.0|11.9|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||20.9|11.9|<0.001
74016568|NCT02889796|147584874|SUPERIORITY||Difference in Response Rates|7.0|||<|0.001|TWO_SIDED|95.0|3.1|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||10.9|3.1|<0.001
74016569|NCT02889796|147584874|SUPERIORITY||Difference in Response Rates|27.4|||<|0.001|TWO_SIDED|95.0|21.4|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||33.3|21.4|<0.001
74045594|NCT02845440|147643591|SUPERIORITY||Odds Ratio (OR)|1.71||||0.032|TWO_SIDED|95.0|1.05|2.79||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.79|1.05|0.032
74016570|NCT02889796|147584874|SUPERIORITY||Difference in Response Rates|16.7|||<|0.001|TWO_SIDED|95.0|10.9|22.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||22.5|10.9|<0.001
74045595|NCT02845440|147643591|SUPERIORITY||Odds Ratio (OR)|1.37||||0.376|TWO_SIDED|95.0|0.68|2.75||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.75|0.68|0.376
73880399|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0096|TWO_SIDED|95.0|1.37|9.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.75|1.37|0.0096
74016571|NCT02889796|147584874|SUPERIORITY||Difference in Response Rates|24.6|||<|0.001|TWO_SIDED|95.0|18.3|31.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||31.0|18.3|<0.001
74016572|NCT02889796|147584874|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||25.8|13.1|<0.001
74016573|NCT02889796|147584876|SUPERIORITY||Difference in Response Rates|2.3||||0.008|TWO_SIDED|95.0|0.5|4.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||4.1|0.5|0.008
74016574|NCT02889796|147584876|SUPERIORITY||Difference in Response Rates|0.8||||0.18|TWO_SIDED|95.0|-0.5|2.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||2.2|-0.5|0.18
74016575|NCT02889796|147584876|SUPERIORITY||Difference in Response Rates|7.6|||<|0.001|TWO_SIDED|95.0|4.6|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||10.6|4.6|<0.001
74016576|NCT02889796|147584876|SUPERIORITY||Difference in Response Rates|1.9||||0.067|TWO_SIDED|95.0|-0.3|4.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||4.0|-0.3|0.067
74016577|NCT02889796|147584876|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|14.6|24.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||24.1|14.6|<0.001
74016578|NCT02889796|147584876|SUPERIORITY||Difference in Response Rates|11.8|||<|0.001|TWO_SIDED|95.0|7.5|16.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||16.2|7.5|<0.001
74016579|NCT02889796|147584876|SUPERIORITY||Difference in Response Rates|21.3|||<|0.001|TWO_SIDED|95.0|15.7|26.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||26.9|15.7|<0.001
74016580|NCT02889796|147584876|SUPERIORITY||Difference in Response Rates|14.6|||<|0.001|TWO_SIDED|95.0|9.2|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||20.0|9.2|<0.001
74016581|NCT02889796|147584878|SUPERIORITY||Difference in Response Rates|22.3|||<|0.001|TWO_SIDED|95.0|16.7|27.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||27.9|16.7|<0.001
74016582|NCT02889796|147584878|SUPERIORITY||Difference in Response Rates|12.6|||<|0.001|TWO_SIDED|95.0|7.2|17.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||17.9|7.2|<0.001
74016583|NCT02889796|147584878|SUPERIORITY||Difference in Response Rates|19.8|||<|0.001|TWO_SIDED|95.0|13.4|26.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||26.1|13.4|<0.001
74016584|NCT02889796|147584878|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|7.5|20.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||20.2|7.5|<0.001
74016585|NCT02889796|147584878|SUPERIORITY||Difference in Response Rates|18.9|||<|0.001|TWO_SIDED|95.0|13.0|24.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||24.9|13.0|<0.001
74016586|NCT02889796|147584878|SUPERIORITY||Difference in Response Rates|18.6|||<|0.001|TWO_SIDED|95.0|12.6|24.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||24.5|12.6|<0.001
74016587|NCT02889796|147584880|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|-0.22|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.22|<0.001
74016588|NCT02889796|147584880|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|-0.14|-0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.14|<0.001
74016589|NCT02889796|147584880|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.028|<|0.001|TWO_SIDED|95.0|-0.24|-0.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.13|-0.24|<0.001
74016590|NCT02889796|147584880|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.028|<|0.001|TWO_SIDED|95.0|-0.15|-0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.15|<0.001
74095788|NCT00593736|147741395|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.297
74016591|NCT02889796|147584880|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.34|-0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-0.34|<0.001
74016592|NCT02889796|147584880|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.26|-0.11||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.26|<0.001
74016593|NCT02889796|147584882|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
74095789|NCT00593736|147741396|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.053
74016594|NCT02889796|147584882|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.01|TWO_SIDED|95.0|-3.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-3.0|0.010
74095790|NCT00593736|147741396|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.837
74095791|NCT00593736|147741396|SUPERIORITY_OR_OTHER|||||||0.783||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.783
74016595|NCT02889796|147584882|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
74016596|NCT02889796|147584882|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
74016597|NCT02889796|147584882|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
74016598|NCT02889796|147584882|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
74016599|NCT02889796|147584882|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
74016600|NCT02889796|147584882|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
74016601|NCT02889796|147584884|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.002|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|0.002
74016602|NCT02889796|147584884|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.047|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|0.047
74016603|NCT02889796|147584884|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
74016604|NCT02889796|147584884|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
74095792|NCT00593736|147741397|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.566
74016605|NCT02889796|147584884|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
74016606|NCT02889796|147584884|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
74095793|NCT00593736|147741397|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.543
74095794|NCT00593736|147741397|SUPERIORITY_OR_OTHER|||||||0.847||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.847
74016607|NCT02889796|147584884|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
74016608|NCT02889796|147584884|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
74016609|NCT02889796|147584886|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-11.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-11.0|<0.001
74016610|NCT02889796|147584886|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
74016611|NCT02889796|147584886|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
74016612|NCT02889796|147584886|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
74016613|NCT02889796|147584886|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-16.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-16.0|<0.001
74016614|NCT02889796|147584886|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
74016615|NCT02889796|147584886|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-14.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-14.0|<0.001
74095795|NCT00593736|147741398|SUPERIORITY_OR_OTHER|||||||0.356||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.356
74016616|NCT02889796|147584886|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
74016617|NCT02889796|147584888|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-10.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-10.0|<0.001
74016618|NCT02889796|147584888|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-8.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-8.0|<0.001
74016619|NCT02889796|147584888|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-11.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-11.0|<0.001
74016620|NCT02889796|147584888|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-9.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-9.0|<0.001
74016621|NCT02889796|147584888|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-10.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-10.0|<0.001
74016622|NCT02889796|147584888|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-10.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-10.0|<0.001
74016623|NCT02889796|147584888|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-11.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-11.0|<0.001
74016624|NCT02889796|147584888|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-10.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-10.0|<0.001
74016625|NCT02889796|147584890|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
74016626|NCT02889796|147584890|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
74095796|NCT00593736|147741398|SUPERIORITY_OR_OTHER|||||||0.964||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.964
74095797|NCT00593736|147741398|SUPERIORITY_OR_OTHER|||||||0.799||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.799
73888055|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8||||0.6595|TWO_SIDED|95.0|-13.1|20.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.7|-13.1|0.6595
74016627|NCT02889796|147584890|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
74045596|NCT02845440|147643591|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.3||||0.645|TWO_SIDED|95.0|0.42|4.05|||Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||4.05|0.42|0.645
74016628|NCT02889796|147584890|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-9.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-9.0|<0.001
74045597|NCT02845440|147643592|SUPERIORITY||Odds Ratio (OR)|1.85|||<|0.001|TWO_SIDED|95.0|1.34|2.56||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|The CHW intervention increased odds of self-reported use of any TUD medication by 1.85.||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||2.56|1.34|<0.001
74045598|NCT02845440|147643592|SUPERIORITY||Odds Ratio (OR)|0.7||||0.084|TWO_SIDED|95.0|0.46|1.05|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||1.05|0.46|0.084
74045599|NCT02845440|147643592|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.22||||0.589|TWO_SIDED|95.0|0.59|2.55|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.||2.55|0.59|0.589
74045600|NCT02845440|147643593|SUPERIORITY||Odds Ratio (OR)|3.05|||<|0.001|TWO_SIDED|95.0|1.99|4.68||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||4.68|1.99|<0.001
74045601|NCT02845440|147643593|SUPERIORITY||Odds Ratio (OR)|0.89||||0.698|TWO_SIDED|95.0|0.51|1.57||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||1.57|0.51|0.698
74095798|NCT00593736|147741399|SUPERIORITY_OR_OTHER|||||||0.698||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.698
74095799|NCT00593736|147741399|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.385
74095800|NCT00593736|147741399|SUPERIORITY_OR_OTHER|||||||0.641||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.641
74095801|NCT00593736|147741400|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.979
74095802|NCT00593736|147741400|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.194
74095803|NCT00593736|147741400|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.004
74095804|NCT00593736|147741401|SUPERIORITY_OR_OTHER|||||||0.975||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.975
74095805|NCT00593736|147741401|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.639
74095806|NCT00593736|147741401|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.109
74095807|NCT00593736|147741402|SUPERIORITY_OR_OTHER|||||||0.823||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.823
73880400|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|6.06||||0.0012|TWO_SIDED|95.0|2.04|17.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||17.96|2.04|0.0012
73880401|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0344|TWO_SIDED|95.0|1.08|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.02|1.08|0.0344
73880402|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|4.07||||0.0045|TWO_SIDED|95.0|1.55|10.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.72|1.55|0.0045
73880403|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.24||||0.081|TWO_SIDED|95.0|0.91|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.55|0.91|0.0810
73880404|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0761|TWO_SIDED|95.0|0.92|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.70|0.92|0.0761
73880405|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0078|TWO_SIDED|95.0|1.41|9.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.51|1.41|0.0078
73880406|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0253|TWO_SIDED|95.0|1.15|7.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.82|1.15|0.0253
73880407|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|6.23||||0.0017|TWO_SIDED|95.0|1.99|19.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||19.55|1.99|0.0017
73880408|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3512|TWO_SIDED|95.0|0.62|3.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.87|0.62|0.3512
73880409|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0352|TWO_SIDED|95.0|1.07|7.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.13|1.07|0.0352
74016629|NCT02889796|147584890|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
74016630|NCT02889796|147584890|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-13.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-13.0|<0.001
74016631|NCT02889796|147584890|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-14.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-14.0|<0.001
74045602|NCT02845440|147643593|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.1||||0.845|TWO_SIDED|95.0|0.43|2.78|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.||2.78|0.43|0.845
73880410|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.36||||0.0704|TWO_SIDED|95.0|0.93|5.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.97|0.93|0.0704
73880411|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.94||||0.1651|TWO_SIDED|95.0|0.76|4.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.93|0.76|0.1651
73880412|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0964|TWO_SIDED|95.0|0.87|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.62|0.87|0.0964
74016632|NCT02889796|147584890|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-12.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-12.0|<0.001
74016633|NCT02889796|147584892|SUPERIORITY||Least Squares Mean Difference|-10.83|STANDARD_ERROR_OF_MEAN|0.952|<|0.001|TWO_SIDED|95.0|-12.7|-8.96||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.96|-12.70|<0.001
74016634|NCT02889796|147584892|SUPERIORITY||Least Squares Mean Difference|-7.73|STANDARD_ERROR_OF_MEAN|0.947|<|0.001|TWO_SIDED|95.0|-9.58|-5.87||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.87|-9.58|<0.001
74016635|NCT02889796|147584892|SUPERIORITY||Least Squares Mean Difference|-9.39|STANDARD_ERROR_OF_MEAN|0.989|<|0.001|TWO_SIDED|95.0|-11.33|-7.45||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.45|-11.33|<0.001
74016636|NCT02889796|147584892|SUPERIORITY||Least Squares Mean Difference|-7.35|STANDARD_ERROR_OF_MEAN|0.987|<|0.001|TWO_SIDED|95.0|-9.29|-5.42||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.42|-9.29|<0.001
74016637|NCT02889796|147584892|SUPERIORITY||Least Squares Mean Difference|-8.02|STANDARD_ERROR_OF_MEAN|0.961|<|0.001|TWO_SIDED|95.0|-9.9|-6.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.13|-9.90|<0.001
74016638|NCT02889796|147584892|SUPERIORITY||Least Squares Mean Difference|-6.46|STANDARD_ERROR_OF_MEAN|0.96|<|0.001|TWO_SIDED|95.0|-8.35|-4.58||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.58|-8.35|<0.001
74016639|NCT02889796|147584892|SUPERIORITY||Least Squares Mean Difference|-7.91|STANDARD_ERROR_OF_MEAN|1.007|<|0.001|TWO_SIDED|95.0|-9.88|-5.93||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.93|-9.88|<0.001
74016640|NCT02889796|147584892|SUPERIORITY||Least Squares Mean Difference|-6.59|STANDARD_ERROR_OF_MEAN|1.005|<|0.001|TWO_SIDED|95.0|-8.56|-4.62||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.62|-8.56|<0.001
74095808|NCT00593736|147741402|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.004
73880413|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0276|TWO_SIDED|95.0|1.13|8.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.59|1.13|0.0276
74016641|NCT02889796|147584894|SUPERIORITY||Difference in Response Rates|12.3|||<|0.001|TWO_SIDED|95.0|5.7|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2.||18.9|5.7|<0.001
74016642|NCT02889796|147584894|SUPERIORITY||Difference in Response Rates|6.5||||0.043|TWO_SIDED|95.0|-0.1|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2.||13.1|-0.1|0.043
74095809|NCT00593736|147741402|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.296
74016643|NCT02889796|147584894|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|9.8|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||22.8|9.8|<0.001
74016644|NCT02889796|147584894|SUPERIORITY||Difference in Response Rates|8.1||||0.011|TWO_SIDED|95.0|1.5|14.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||14.7|1.5|0.011
74016645|NCT02889796|147584894|SUPERIORITY||Difference in Response Rates|21.0|||<|0.001|TWO_SIDED|95.0|14.9|27.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||27.0|14.9|<0.001
74016646|NCT02889796|147584894|SUPERIORITY||Difference in Response Rates|13.6|||<|0.001|TWO_SIDED|95.0|7.3|19.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||19.9|7.3|<0.001
74095810|NCT00593736|147741403|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.092
73880414|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|4.99||||0.006|TWO_SIDED|95.0|1.58|15.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.70|1.58|0.0060
74016647|NCT02889796|147584894|SUPERIORITY||Difference in Response Rates|16.6|||<|0.001|TWO_SIDED|95.0|10.5|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||22.8|10.5|<0.001
74016648|NCT02889796|147584894|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|7.8|20.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||20.3|7.8|<0.001
74016649|NCT02889796|147584896|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
74016650|NCT02889796|147584896|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.5|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.5|<0.001
74016651|NCT02889796|147584896|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.9|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-0.9|<0.001
74016652|NCT02889796|147584896|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.7|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.7|<0.001
74095811|NCT00593736|147741403|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.025
74016653|NCT02889796|147584896|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
74016654|NCT02889796|147584896|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
74095812|NCT00593736|147741403|SUPERIORITY_OR_OTHER|||||||0.732||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.732
74016655|NCT02889796|147584896|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
74095813|NCT00593736|147741404|SUPERIORITY_OR_OTHER|||||||0.298||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.298
74095814|NCT00593736|147741404|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.276
74095815|NCT00593736|147741404|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.430
74045603|NCT02845440|147643594|SUPERIORITY||Odds Ratio (OR)|1.42||||0.158|TWO_SIDED|95.0|0.92|2.2||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of TUD medication use on abstinence rates attributable to the CHW intervention was 55.6%.|2.20|0.92|0.158
74095816|NCT00593736|147741405|SUPERIORITY_OR_OTHER|||||||0.349||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.349
74095817|NCT00593736|147741405|SUPERIORITY_OR_OTHER|||||||0.203||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.203
74045604|NCT02845440|147643595|SUPERIORITY||Odds Ratio (OR)|1.89||||0.013|TWO_SIDED|95.0|1.14|3.13||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as varenicline use and a clinic-varying random intercept. Regression coefficients and mediation analysis estimates were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of varenicline use on abstinence rates attributable to the CHW intervention was 36.6%.|3.13|1.14|0.013
74045605|NCT02845440|147643596|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.505|TWO_SIDED|95.0|-0.16|0.33|||Regression, Linear|||The model had a clinic varying random intercept. This statistical model included cohort 1: TAU , AD, and AD+CHW||0.33|-0.16|0.505
74045606|NCT02845440|147643596|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.848|TWO_SIDED|95.0|-0.22|0.27||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.27|-0.22|0.848
74016656|NCT02889796|147584896|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
74016657|NCT02889796|147584898|SUPERIORITY||Difference in Response Rates|9.5|||<|0.001|TWO_SIDED|95.0|5.8|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||13.1|5.8|<0.001
74016658|NCT02889796|147584898|SUPERIORITY||Difference in Response Rates|4.5||||0.004|TWO_SIDED|95.0|1.4|7.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||7.7|1.4|0.004
74095818|NCT00593736|147741405|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.444
74095819|NCT00593736|147741406|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.581
74095820|NCT00593736|147741406|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.257
74095821|NCT00593736|147741406|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.688
74095822|NCT00593736|147741407|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.561
74095823|NCT00593736|147741407|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.595
74095824|NCT00593736|147741407|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.795
74095825|NCT00593736|147741408|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.655
74095826|NCT00593736|147741408|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.177
74095827|NCT00593736|147741408|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.044
74095828|NCT00593736|147741409|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.475
74095829|NCT00593736|147741409|SUPERIORITY_OR_OTHER|||||||0.635||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.635
74095830|NCT00593736|147741409|SUPERIORITY_OR_OTHER|||||||0.782||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.782
74016659|NCT02889796|147584898|SUPERIORITY||Difference in Response Rates|16.2|||<|0.001|TWO_SIDED|95.0|11.3|21.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||21.1|11.3|<0.001
74016660|NCT02889796|147584898|SUPERIORITY||Difference in Response Rates|11.2|||<|0.001|TWO_SIDED|95.0|6.5|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||15.8|6.5|<0.001
74016661|NCT02889796|147584898|SUPERIORITY||Difference in Response Rates|26.9|||<|0.001|TWO_SIDED|95.0|20.6|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||33.3|20.6|<0.001
74016662|NCT02889796|147584898|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||25.8|13.1|<0.001
74016663|NCT02889796|147584900|SUPERIORITY||Difference in Response Rates|4.4|||<|0.001|TWO_SIDED|95.0|2.1|6.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2.||6.7|2.1|<0.001
74016664|NCT02889796|147584900|SUPERIORITY||Difference in Response Rates|1.0||||0.17|TWO_SIDED|95.0|-0.5|2.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2.||2.6|-0.5|0.17
74016665|NCT02889796|147584900|SUPERIORITY||Difference in Response Rates|10.7|||<|0.001|TWO_SIDED|95.0|7.1|14.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||14.4|7.1|<0.001
74095831|NCT00593736|147741410|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.192
74095832|NCT00593736|147741410|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.618
74095833|NCT00593736|147741410|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.152
74095834|NCT00593736|147741411|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.379
74095835|NCT00593736|147741411|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.057
74095836|NCT00593736|147741411|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.808
74095837|NCT00593736|147741412|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.284
74095838|NCT00593736|147741412|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.344
74095839|NCT00593736|147741412|SUPERIORITY_OR_OTHER|||||||0.558||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.558
74095840|NCT00593736|147741413|SUPERIORITY_OR_OTHER|||||||0.867||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.867
74095841|NCT00593736|147741413|SUPERIORITY_OR_OTHER|||||||0.244||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.244
74095842|NCT00593736|147741413|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.620
73888056|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6||||0.3176|TWO_SIDED|95.0|-8.3|25.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.5|-8.3|0.3176
74016666|NCT02889796|147584900|SUPERIORITY||Difference in Response Rates|5.8|||<|0.001|TWO_SIDED|95.0|2.6|9.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||9.0|2.6|<0.001
74016667|NCT02889796|147584900|SUPERIORITY||Difference in Response Rates|32.2|||<|0.001|TWO_SIDED|95.0|26.4|38.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||38.0|26.4|<0.001
74016668|NCT02889796|147584900|SUPERIORITY||Difference in Response Rates|19.0|||<|0.001|TWO_SIDED|95.0|13.4|24.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||24.6|13.4|<0.001
74016669|NCT02889796|147584900|SUPERIORITY||Difference in Response Rates|12.7|||<|0.001|TWO_SIDED|95.0|5.6|19.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 24.||19.9|5.6|<0.001
74016670|NCT02889796|147584900|SUPERIORITY||Difference in Response Rates|-0.5||||0.88|TWO_SIDED|95.0|-7.5|6.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 24.||6.5|-7.5|0.88
74016671|NCT02889796|147584900|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 at using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 24.||||<0.001
74016672|NCT02889796|147584900|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 at using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 24.||||<0.001
74016673|NCT02889796|147584906|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-5.9|-3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.2|-5.9|<0.001
74016674|NCT02889796|147584906|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-4.3|-1.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-4.3|<0.001
74016675|NCT02889796|147584906|SUPERIORITY||Least Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-6.6|-3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.8|-6.6|<0.001
74016676|NCT02889796|147584906|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-5.3|-2.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.4|-5.3|<0.001
74016677|NCT02889796|147584906|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-7.3|-4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.6|-7.3|<0.001
74016678|NCT02889796|147584906|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_DEVIATION|0.69|<|0.001|TWO_SIDED|95.0|-5.8|-3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.1|-5.8|<0.001
74016679|NCT02889796|147584906|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-6.9|-4.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-6.9|<0.001
74016680|NCT02889796|147584906|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-5.3|-2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-5.3|<0.001
74016681|NCT02889796|147584908|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-7.1|-4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.4|-7.1|<0.001
74016682|NCT02889796|147584908|SUPERIORITY||Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.0|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-5.0|<0.001
74016683|NCT02889796|147584908|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-7.6|-4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.6|-7.6|<0.001
74016684|NCT02889796|147584908|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-6.0|-3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.1|-6.0|<0.001
74016685|NCT02889796|147584908|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|-8.2|-5.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.4|-8.2|<0.001
74016686|NCT02889796|147584908|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|-6.5|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-6.5|<0.001
74045607|NCT02845440|147643596|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.529|TWO_SIDED|95.0|-0.13|0.25||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.25|-0.13|0.529
74095843|NCT00593736|147741414|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.206
74016687|NCT02889796|147584908|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-7.8|-5.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.3|-7.8|<0.001
74016688|NCT02889796|147584908|SUPERIORITY||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-6.1|-3.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.5|-6.1|<0.001
74016689|NCT02889796|147584910|SUPERIORITY||Least Squares Mean Difference|-0.39||||0.042|TWO_SIDED|95.0|-0.77|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.77|0.042
74095844|NCT00593736|147741414|SUPERIORITY_OR_OTHER|||||||0.559||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.559
74095845|NCT00593736|147741414|SUPERIORITY_OR_OTHER|||||||0.074||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.074
74016690|NCT02889796|147584910|SUPERIORITY||Least Squares Mean Difference|-0.39||||0.039|TWO_SIDED|95.0|-0.77|-0.02||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.02|-0.77|0.039
74016691|NCT02889796|147584911|SUPERIORITY||Difference in non-progression rate|6.6||||0.002|TWO_SIDED|95.0|2.2|11.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.||11.1|2.2|0.002
74045608|NCT02845440|147643597|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.937|TWO_SIDED|95.0|-0.16|0.18|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.18|-0.16|0.937
74045609|NCT02845440|147643597|SUPERIORITY||Median Difference (Final Values)|0.05||||0.683|TWO_SIDED|95.0|-0.19|0.29|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.29|-0.19|0.683
74045610|NCT02845440|147643597|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Mean Difference (Final Values)|0.3||||0.19|TWO_SIDED|95.0|-0.15|0.74|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.74|-0.15|0.190
74045611|NCT01704976|147643607|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
74045612|NCT01704976|147643608|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
74095846|NCT00593736|147741415|SUPERIORITY_OR_OTHER|||||||0.796||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.796
74095847|NCT00593736|147741415|SUPERIORITY_OR_OTHER|||||||0.546||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.546
74045613|NCT01704976|147643609|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
74045614|NCT01704976|147643610|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
74045615|NCT01704976|147643611|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
74045616|NCT02977507|147643612|OTHER|||||||0.041|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.041
74095848|NCT00593736|147741415|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.479
74095849|NCT00593736|147741416|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.766
74016692|NCT02889796|147584911|SUPERIORITY||Difference in non-progression rate|3.9||||0.073|TWO_SIDED|95.0|-0.8|8.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.||8.6|-0.8|0.073
74016693|NCT02889796|147584911|SUPERIORITY||Difference in non-progression rate|7.0||||0.009|TWO_SIDED|95.0|1.5|12.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.||12.5|1.5|0.009
74045617|NCT02977507|147643612|OTHER|||||||0.0005|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0005
74045618|NCT02977507|147643613|OTHER|||||||0.002|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.002
74045619|NCT02977507|147643613|OTHER|||||||0.0001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0001
74045620|NCT02977507|147643614|OTHER|||||||0.004|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.004
74045621|NCT02977507|147643614|OTHER|||||||0.001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.001
74045622|NCT02977507|147643618|OTHER|||||||0.003|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.003
74045623|NCT02977507|147643618|OTHER|||||||0.0007|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0007
74045624|NCT02977507|147643620|OTHER|||||||0.569|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.569
74045625|NCT02977507|147643620|OTHER|||||||9e-05|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.00009
74095850|NCT00593736|147741416|SUPERIORITY_OR_OTHER|||||||0.912||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.912
74045626|NCT02977507|147643620|OTHER|||||||0.821|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.821
73880415|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1556|TWO_SIDED|95.0|0.76|5.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.39|0.76|0.1556
73880416|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0202|TWO_SIDED|95.0|1.21|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.18|1.21|0.0202
73880417|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2063|TWO_SIDED|95.0|0.72|4.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.67|0.72|0.2063
73880418|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0383|TWO_SIDED|95.0|1.06|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.92|1.06|0.0383
73880419|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0118|TWO_SIDED|95.0|1.32|9.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.10|1.32|0.0118
73880420|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0314|TWO_SIDED|95.0|1.1|7.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.97|1.10|0.0314
73880421|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|6.8||||0.001|TWO_SIDED|95.0|2.17|21.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||21.34|2.17|0.0010
73880422|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.24||||0.0956|TWO_SIDED|95.0|0.87|5.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.80|0.87|0.0956
73880423|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0027|TWO_SIDED|95.0|1.72|13.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.40|1.72|0.0027
74016694|NCT02889796|147584911|SUPERIORITY||Difference in non-progression rate|5.0||||0.061|TWO_SIDED|95.0|-0.6|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.||10.6|-0.6|0.061
74045627|NCT02977507|147643620|OTHER|||||||0.502|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.502
73880424|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.41||||0.066|TWO_SIDED|95.0|0.94|6.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.14|0.94|0.0660
73880425|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.32||||0.0853|TWO_SIDED|95.0|0.89|6.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.05|0.89|0.0853
74045628|NCT02977507|147643620|OTHER|||||||0.81|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.810
73880426|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.49||||0.0159|TWO_SIDED|95.0|1.26|9.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.62|1.26|0.0159
73880427|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0303|TWO_SIDED|95.0|1.12|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.53|1.12|0.0303
73880428|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|4.84||||0.0071|TWO_SIDED|95.0|1.54|15.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||15.28|1.54|0.0071
74016695|NCT02889796|147584911|SUPERIORITY||Difference in non-progression rate|5.5||||0.004|TWO_SIDED|95.0|1.6|9.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).||9.4|1.6|0.004
74016696|NCT02889796|147584911|SUPERIORITY||Difference in non-progression rate|4.7||||0.012|TWO_SIDED|95.0|0.7|8.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).||8.8|0.7|0.012
74045629|NCT02977507|147643620|OTHER|||||||0.435|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.435
74045630|NCT00633360|147643632|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||.59
74045631|NCT00633360|147643633|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||.29
73880429|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0621|TWO_SIDED|95.0|0.95|7.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.09|0.95|0.0621
73880430|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0081|TWO_SIDED|95.0|1.45|12.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.15|1.45|0.0081
73880431|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0533|TWO_SIDED|95.0|0.99|7.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.09|0.99|0.0533
73880432|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.71||||0.2666|TWO_SIDED|95.0|0.66|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.42|0.66|0.2666
73880433|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0754|TWO_SIDED|95.0|0.91|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.52|0.91|0.0754
73880434|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0313|TWO_SIDED|95.0|1.11|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.64|1.11|0.0313
73880435|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|5.76||||0.0056|TWO_SIDED|95.0|1.67|19.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||19.88|1.67|0.0056
73880436|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0736|TWO_SIDED|95.0|0.91|7.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.28|0.91|0.0736
74016697|NCT02889796|147584915|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.9|3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|1.9|<0.001
74095851|NCT00593736|147741416|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.952
73880437|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0184|TWO_SIDED|95.0|1.24|10.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||10.00|1.24|0.0184
73880438|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1187|TWO_SIDED|95.0|0.82|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.81|0.82|0.1187
73880439|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0299|TWO_SIDED|95.0|1.14|12.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.69|1.14|0.0299
73880440|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5989|TWO_SIDED|95.0|0.4|4.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.89|0.40|0.5989
73880441|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1337|TWO_SIDED|95.0|0.74|9.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.14|0.74|0.1337
73880442|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4605|TWO_SIDED|95.0|0.45|5.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.89|0.45|0.4605
74016698|NCT02889796|147584915|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.0|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|1.0|<0.001
74095852|NCT00593736|147741417|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.722
74016699|NCT02889796|147584915|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.1|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.1|<0.001
74045632|NCT03241589|147643642|SUPERIORITY||Odds Ratio (OR)|0.931||||0.7428|TWO_SIDED|95.0|0.606|1.429|||Regression, Logistic||Referent group is Urban|We followed power calculations described in uploaded protocol document, using an incomplete design matrix with a 3-month transition period, a level of precision α=0.05 and a minimum power level of 0.80. We also assumed a total number of clusters I=36 as per the study design and the number of baseline measurements B=2. Due to insufficient sample size, we modified groups studied.||1.429|0.606|0.7428
74016700|NCT02889796|147584915|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.0|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.0|<0.001
74016701|NCT02889796|147584919|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|0.9|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.9|<0.001
74045633|NCT03241589|147643643|SUPERIORITY||Odds Ratio (OR)|2.258||||0.0031|TWO_SIDED|95.0|1.181|4.315|||Regression, Logistic|2 degrees of freedom, Wald Chi-Square 11.5759|Veterans with expired requests = referent.|||4.315|1.181|0.0031
74045634|NCT05103475|147643648|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||1||||||The investigators used Fisher's exact due to small cell sizes.|Fisher Exact|The reported value represents the calculated p-value for the Fisher's Exact test.||||||1.0
74045635|NCT05103475|147643649|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.35|||||||t-test, 2 sided|||||||0.35
74045636|NCT05103475|147643650|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.15||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||||||0.15
74045637|NCT05103475|147643651|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.43|||||||t-test, 2 sided|||Pre/post comparison for control group scores.||||0.43
74045638|NCT05103475|147643651|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.24|||||||t-test, 2 sided|||Pre/post comparison for RAP group score.||||0.24
74045639|NCT05103475|147643651|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.53||||||F = 0.41|ANOVA|||ANOVA results - group x time interaction.||||0.53
74045640|NCT05103475|147643652|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.7|||||||t-test, 2 sided|||Pre/post comparison for control group.||||0.70
74045641|NCT05103475|147643652|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.17|||||||t-test, 2 sided|||Pre/post comparison for RAP group.||||0.17
74045642|NCT05103475|147643652|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.18||||||F = 1.95|ANOVA|||ANOVA results - group x time interaction.||||0.18
74045643|NCT05103475|147643653|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.37|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.37
74045644|NCT05103475|147643653|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.5|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.50
74045645|NCT05103475|147643653|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.9||||||F = 0.01|ANOVA|||ANOVA results - group x time interaction.||||0.90
74045646|NCT05103475|147643654|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.56|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.56
74045647|NCT05103475|147643654|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.32|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.32
74045648|NCT05103475|147643654|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.41||||||F = 0.71|ANOVA|||ANOVA results - group x time interaction.||||0.41
74045649|NCT05103475|147643655|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.5|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.50
74045650|NCT05103475|147643655|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.6|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.60
74045651|NCT05103475|147643655|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.98||||||F = 0.0|ANOVA|||ANOVA results - group x time interaction.||||0.98
74045652|NCT05103475|147643656|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.54|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.54
74045653|NCT05103475|147643656|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.15|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.15
74045654|NCT05103475|147643656|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.04||||||F = 4.9|ANOVA|||ANOVA results - group x time interaction.||||0.04
74045655|NCT05103475|147643657|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.11|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.11
74045656|NCT05103475|147643657|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.09|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.09
74016702|NCT02889796|147584919|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.48||0.002|TWO_SIDED|95.0|0.6|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|0.6|0.002
74016703|NCT02889796|147584919|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.52||0.006|TWO_SIDED|95.0|0.4|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|0.4|0.006
74016704|NCT02889796|147584919|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.52||0.001|TWO_SIDED|95.0|0.7|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|0.7|0.001
74045657|NCT05103475|147643657|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.75||||||F = 0.10|ANOVA|||ANOVA results - group x time interaction.||||0.75
73880443|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0188|TWO_SIDED|95.0|1.28|15.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||15.65|1.28|0.0188
74016705|NCT02889796|147584919|SUPERIORITY||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.55||0.086|TWO_SIDED|95.0|-0.1|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.1|0.086
74016706|NCT02889796|147584919|SUPERIORITY||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.55||0.12|TWO_SIDED|95.0|-0.2|1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.9|-0.2|0.12
74016707|NCT02889796|147584923|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.8|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.8|<0.001
74016708|NCT02889796|147584923|SUPERIORITY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.2|3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.2|1.2|<0.001
74016709|NCT02889796|147584923|SUPERIORITY||Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.5|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.5|<0.001
74016710|NCT02889796|147584923|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.6|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.6|<0.001
74016711|NCT02889796|147584929|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.049|TWO_SIDED|95.0|0.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|0.0|0.049
74045658|NCT05103475|147643658|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.41|||||||Fisher Exact|The investigators used Fisher's Exact due to small cell sizes.||Likelihood to participate in a program like it in the future||||0.41
74045659|NCT05103475|147643658|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.003||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||Help to manage back pain.||||0.003
74045660|NCT05103475|147643658|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||1||||||The investigators used Fisher's Exact due to small sample sizes.|Fisher Exact|The reported value represents the calculated p-value for the Fisher's Exact test.||Would recommend to another Veteran.||||1.00
74095853|NCT00593736|147741417|SUPERIORITY_OR_OTHER|||||||0.262||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.262
74095854|NCT00593736|147741417|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.717
74095855|NCT00593736|147741418|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.498
74095856|NCT00593736|147741418|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.664
73880444|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5854|TWO_SIDED|95.0|0.39|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.42|0.39|0.5854
73880445|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1768|TWO_SIDED|95.0|0.68|7.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.86|0.68|0.1768
73880446|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8426|TWO_SIDED|95.0|0.29|2.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.78|0.29|0.8426
73880447|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3017|TWO_SIDED|95.0|0.17|1.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.73|0.17|0.3017
73880448|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5958|TWO_SIDED|95.0|0.21|2.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.43|0.21|0.5958
73880449|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|0.23||||0.0515|TWO_SIDED|95.0|0.05|1.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.01|0.05|0.0515
73880450|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9734|TWO_SIDED|95.0|0.31|3.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.11|0.31|0.9734
74095857|NCT00593736|147741418|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.428
74095858|NCT00593736|147741419|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.519
74095859|NCT00593736|147741419|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.179
74095860|NCT00593736|147741419|SUPERIORITY_OR_OTHER|||||||0.935||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.935
74095861|NCT00593736|147741420|SUPERIORITY_OR_OTHER|||||||0.425||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.425
74095862|NCT00593736|147741420|SUPERIORITY_OR_OTHER|||||||0.406||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.406
74095863|NCT00593736|147741420|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.720
73880451|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|0.85||||0.7969|TWO_SIDED|95.0|0.25|2.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.93|0.25|0.7969
73888057|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0||||0.6423|TWO_SIDED|95.0|-12.9|20.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.9|-12.9|0.6423
73880452|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|0.78||||0.6637|TWO_SIDED|95.0|0.25|2.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.40|0.25|0.6637
74016712|NCT02889796|147584929|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.069|TWO_SIDED|95.0|0.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|-0.0|0.069
74016713|NCT02889796|147584929|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|4.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|4.0|<0.001
74016714|NCT02889796|147584929|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|4.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|4.0|<0.001
74016715|NCT02889796|147584929|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.5||0.06|TWO_SIDED|95.0|0.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-0.0|0.060
74016716|NCT02889796|147584929|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.5||0.003|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|0.003
74016717|NCT02479802|147584949|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Change from Baseline at Week 48.||||<0.0001
74016718|NCT02479802|147584950|OTHER|||||||0.0006|||||||t-test, 1 sided|||Change from Baseline at Week 48.||||0.0006
74016719|NCT01978093|147584961|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-PRP concentrations ≥1.0 mg/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.96|||||TWO_SIDED|95.0|-2.12|4.3|||Group difference in proportions|Before concluding on the primary objectives for Rotarix, Prevnar 13 and Havrix, this primary objective regarding anti-PRP needs to be reached||Difference between HibCY and PedHIB groups in percentage of subjects with anti-PRP concentrations equal to or above the cut-off value of 1.0 µg/mL one month after the fourth dose in HibCY Group and third dose in PedHIB Group.||4.30|-2.12|
74016720|NCT01978093|147584962|NON_INFERIORITY|Non-inferiority is concluded if lower limit of the two-sided standardized asymptotic 97.5% CI on the ratio of anti-rotavirus IgA GMC (HibCY group over PedHIB group) is to be ≥0.5|Adjusted GMC ratios|1.21|||||TWO_SIDED|97.5|0.77|1.9|||ANCOVA|GMC adjusted for BS sub-cohorts;97.5% confidence interval calculated for adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 Post dose 3)\& Epoch 002 (Havrix \& Prevnar13 post dose 4),a Bonferroni correction is used in order to test these objectives(1.25% 1sided for Epoch 001 \& 002)|GMC ratios between HibCY and PedHIB groups for anti-Rota IgA concentrations 2 months after the second dose of Rotarix vaccine||1.90|0.77|
74016721|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.95|1.47|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio (Ancova Model: adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix \& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the third dose.||1.47|0.95|
74016722|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.15|||||TWO_SIDED|97.5|0.93|1.42|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the third dose.||1.42|0.93|
74045661|NCT05103475|147643658|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.07||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||Liked the program.||||0.07
74045662|NCT05103475|147643659|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.91|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.91
74016723|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.08|||||TWO_SIDED|97.5|0.9|1.31|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the third dose.||1.31|0.90|
74016724|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.95|1.47|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the third dose.||1.47|0.95|
74016725|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.29|||||TWO_SIDED|97.5|1.03|1.63|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the third dose.||1.63|1.03|
74016726|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.17|||||TWO_SIDED|97.5|0.88|1.55|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the third dose.||1.55|0.88|
74045663|NCT05103475|147643659|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.51|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.51
73880453|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.53||||0.4921|TWO_SIDED|95.0|0.45|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.15|0.45|0.4921
74016727|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.11|||||TWO_SIDED|97.5|0.91|1.34|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the third dose.||1.34|0.91|
74045664|NCT05103475|147643659|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.42||||||F = 0.68|ANOVA|||ANOVA results - group x time interaction.||||0.42
74045665|NCT01449955|147643695|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||ANOVA comparing the results of change over time (e.g., comparing baseline to 1 month posttreatment) as well as comparing differences between condition (e.g., placebo compared to rapamycin).||||>0.05
74045666|NCT01449955|147643696|SUPERIORITY||||||>|0.5|||||||ANOVA|||||||> 0.5
74045667|NCT01449955|147643697|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
74045668|NCT01449955|147643698|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
74045669|NCT01449955|147643699|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< .05
74045670|NCT01449955|147643700|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
74045671|NCT01332097|147643701|SUPERIORITY||Least squares mean difference|54.2|||||TWO_SIDED|95.0|-41.7|150.1||||||LS Mean difference: Treatment A vs. Treatment B, E, G \& I (placebo) Day 5||150.1|-41.7|
74045672|NCT01332097|147643701|SUPERIORITY||Least squares mean difference|-52.0|||||TWO_SIDED|95.0|-148.5|44.5||||||LS Mean difference: Treatment C vs. Treatment B, E, G \& I (placebo) Day 5||44.5|-148.5|
74045673|NCT01332097|147643701|SUPERIORITY||Least squares mean difference|5.5|||||TWO_SIDED|95.0|-96.0|106.9||||||LS Mean difference: Treatment D vs. Treatment B, E, G \& I (placebo) Day 5||106.9|-96.0|
74045674|NCT01332097|147643701|SUPERIORITY||Least squares mean difference|33.5|||||TWO_SIDED|95.0|-66.8|133.9||||||LS Mean difference: Treatment F vs. Treatment B, E, G \& I (placebo) Day 5||133.9|-66.8|
74045675|NCT01332097|147643701|SUPERIORITY||Least squares mean difference|99.8|||||TWO_SIDED|95.0|-2.4|202.0||||||LS Mean difference: Treatment H vs. Treatment B, E, G \& I (placebo) Day 5||202.0|-2.4|
74045676|NCT01332097|147643701|SUPERIORITY||Least squares mean difference|37.8|||||TWO_SIDED|95.0|-107.1|182.6||||||LS Mean difference: Treatment A vs. Treatment B, E, G \& I (placebo) Day 10||182.6|-107.1|
74045677|NCT01332097|147643701|SUPERIORITY||Least squares mean difference|-72.0|||||TWO_SIDED|95.0|-215.7|71.8||||||LS Mean difference: Treatment C vs. Treatment B, E, G \& I (placebo) Day 10||71.8|-215.7|
74016728|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||TWO_SIDED|97.5|1.0|1.55|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the third dose.||1.55|1.00|
73880454|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.09||||0.891|TWO_SIDED|95.0|0.33|3.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.64|0.33|0.8910
74016729|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.9|1.5|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the third dose.||1.50|0.90|
74095864|NCT00593736|147741421|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.294
74095865|NCT00593736|147741421|SUPERIORITY_OR_OTHER|||||||0.474||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.474
74016730|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.24|||||TWO_SIDED|97.5|1.01|1.52|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the third dose.||1.52|1.01|
74016731|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.94|1.43|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the third dose.||1.43|0.94|
74016732|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.07|||||TWO_SIDED|97.5|0.89|1.29|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the third dose.||1.29|0.89|
74016733|NCT01978093|147584963|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.91|1.53|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the third dose.||1.53|0.91|
74045678|NCT01332097|147643701|SUPERIORITY||Least squares mean difference|-72.3|||||TWO_SIDED|95.0|-241.5|96.9||||||LS Mean difference: Treatment D vs. Treatment B, E, G \& I (placebo) Day 10||96.9|-241.5|
74045679|NCT01332097|147643701|SUPERIORITY||Least squares mean difference|-17.9|||||TWO_SIDED|95.0|-154.9|119.2||||||LS Mean difference: Treatment F vs. Treatment B, E, G \& I (placebo) Day 10||119.2|-154.9|
74045680|NCT01332097|147643701|SUPERIORITY||Least squares mean difference|123.6|||||TWO_SIDED|95.0|-15.8|263.0||||||LS Mean difference: Treatment H vs. Treatment B, E, G \& I (placebo) Day 10||263.0|-15.8|
74045681|NCT00431496|147643703|SUPERIORITY_OR_OTHER||Percentage of participants|42.3||||||95.0|30.8|53.7||||||||53.7|30.8|
74045682|NCT00431496|147643704|SUPERIORITY_OR_OTHER||Percentage of participants|52.1||||||95.0|40.5|63.7||||||||63.7|40.5|
74045683|NCT00431496|147643705|SUPERIORITY_OR_OTHER||Percentage of participants|78.9||||||95.0|69.4|88.4||||||||88.4|69.4|
74045684|NCT00431496|147643706|SUPERIORITY_OR_OTHER||Percentage of participants|54.9||||||95.0|43.4|66.5||||||||66.5|43.4|
74045685|NCT00431496|147643707|SUPERIORITY_OR_OTHER||Percentage of participants|53.5||||||95.0|41.9|65.1||||||||65.1|41.9|
74045686|NCT00431496|147643708|SUPERIORITY_OR_OTHER||Percentage of participants|46.5||||||95.0|34.9|58.1||||||||58.1|34.9|
74045687|NCT04018612|147643709|SUPERIORITY||LS Mean Difference|-21.84|STANDARD_ERROR_OF_MEAN|11.091||0.0258|ONE_SIDED|90.0||-7.53|||ANCOVA||SPID24 was analyzed using ANCOVA model with treatment group as a fixed effect and baseline (BL) Pain Intensity-Numerical Pain Relief Scale (PI-NPRS) as a covariate. The lower limit of one-sided 90% confidence interval (CI) was -∞|||-7.53||0.0258
74045688|NCT04018612|147643709|SUPERIORITY||LS Mean Difference|-25.74|STANDARD_ERROR_OF_MEAN|11.154||0.0115|ONE_SIDED|90.0||-11.35|||ANCOVA||SPID24 was analyzed using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The lower limit of one-sided 90% CI was -∞|||-11.35||0.0115
74045689|NCT04018612|147643710|SUPERIORITY||LS Mean Difference|12.72|STANDARD_ERROR_OF_MEAN|5.267||0.0087|ONE_SIDED|90.0|5.92||||ANCOVA||TOTPAR24 was analyzed using an ANCOVA model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The upper limit of one-sided 90% CI was +∞||||5.92|0.0087
74045690|NCT04018612|147643710|SUPERIORITY||LS Mean Difference|12.14|STANDARD_ERROR_OF_MEAN|5.297||0.012|ONE_SIDED|90.0|5.31||||ANCOVA||TOTPAR24 was analyzed using an ANCOVA model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The upper limit of one-sided 90% CI was +∞||||5.31|0.0120
74045691|NCT02566109|147643736|OTHER|Estimation of Pearson correlation|Pearson Correlation Coefficient|-0.57472||||0.6102|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.6102
74045692|NCT02566109|147643736|OTHER|Correlation|Pearson Correlation Coefficient|0.25733||||0.8343|TWO_SIDED||||||Peason Correlation Coefficient|||Correlation between baseline and 6 months.||||0.8343
74045693|NCT02566109|147643737|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|-0.09487||||0.9395|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.9395
74095866|NCT00593736|147741421|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.999
74045694|NCT02566109|147643737|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.97287||||0.1486|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.||||0.1486
74045695|NCT02566109|147643738|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.10327||||0.9341|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.9341
74045696|NCT02566109|147643738|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.99696||||0.0497|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.||||0.0497
74045697|NCT02566109|147643739|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.98432||||0.1129|TWO_SIDED||||||Pearson Correlation Coefficient|||||||0.1129
74045698|NCT01906476|147643744|NON_INFERIORITY|Non-inferiority trials of pharmaceuticals have used 30% to 50% of the difference between treatment and control conditions to define non-inferiority margins. (Jones, Jarvis, Lewis, \& Ebbutt, 1996; Nutt et al., 2008). A meta-analysis of CBT found an overall effect size of d=0.82.(Cuijpers, Smit, Bohlmeijer, Hollon, \& Andersson, 2010). Using the midpoint of 40% for the acceptable criterion, we set d=0.33 as the non-inferiority criterion.|||||||||||||||||"Cohen's d and upper limits of one-sided 95% Confidence intervals for each time are as follows:~Mid-treatment -0.19 (95% upper limit= 0.06) End of treatment 0.03 (0.24) 3 months post treatment -0.02 (0.19) 6 months post treatment -0.07 (0.14)"|||
74045699|NCT01906476|147643745|SUPERIORITY||ICER estimate|-152.55|||||TWO_SIDED|95.0|-1143.09|1094.72||||||We calculated the ICER (Incremental cost-effectiveness ratio) estimate, computed using the difference in average cost between the two arms, divided by the difference in average Depression Free Days (DFD) as defined using QIDS (Quick Inventory of Depressive Symptomatology), between the two arms, Stepped Care minus Telephone Cognitive Behavior Therapy. The confidence interval was created using bootstrapping.||1094.72|-1143.09|
74095867|NCT00593736|147741422|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.655
74045700|NCT01248585|147643749|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.053||0.05|TWO_SIDED|90.0|0.0|0.177||1-sided p-value.|Cochran-Mantel-Haenszel|||One-sided 0.05 level test with 90% power, 298 participants required.||0.177|0|0.05
74045701|NCT01248585|147643750|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.009||||0.432|TWO_SIDED|95.0|-0.08|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.08|0.432
74045702|NCT01248585|147643752|SUPERIORITY||Risk Difference (RD)|0.09||||0.15|TWO_SIDED|90.0|0.01|0.18||Fisher exact test.|Fisher Exact|||||0.18|0.01|0.15
74045703|NCT01248585|147643753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.55||||0.07|TWO_SIDED|90.0|-5.06|3.97|||Wilcoxon (Mann-Whitney)|||||3.97|-5.06|0.07
74045704|NCT00118404|147643792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.079|STANDARD_ERROR_OF_MEAN|0.39||0.42|TWO_SIDED|95.0|0.5|2.34|||Log Rank|log-rank chi-square = 0.038, df = 1, p \<=.42|Hazard ratio for relapse in C-CT group compared to that in the fluoxetine group.|The sample size was based on a predicted 30% difference in relapse/recurrence rates between C-CT and fluoxetine (ie,30% vs 60%) across both the experimental phase and the first 12 months of follow-up. With these assumptions, 180 randomized patients (60 per cell) were required to detect a statistically significant difference using a log-rank test with 1-sided α = 0.05 and 80% power.||2.34|0.50|.42
74095868|NCT00593736|147741422|SUPERIORITY_OR_OTHER|||||||0.331||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.331
74045705|NCT00118404|147643792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.481|STANDARD_ERROR_OF_MEAN|0.38||0.02|TWO_SIDED|95.0|0.23|1.01|||Log Rank|log-rank chi-square = 3.92, df = 1|Hazard Ratio for relapse in fluoxetine group compared to that in the pill placebo group.|||1.01|.23|.02
74045706|NCT00118404|147643792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.519|STANDARD_ERROR_OF_MEAN|0.36||0.03|TWO_SIDED|95.0|0.26|1.06|||Log Rank|log-rank chi-square = 3.391, df = 1|Hazard ratio for relapse in C-CT group compared to that in the placebo group.|||1.06|0.26|.03
74045707|NCT00118404|147643792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.501|STANDARD_ERROR_OF_MEAN|0.31||0.01|TWO_SIDED|95.0|0.27|0.93|||Log Rank|log-rank chi-square = 5.06, df = 1|Hazard ratio for relapse in active treatment group (fluoxetine or C-CT) compared to that in the placebo group.|||0.93|0.27|.01
74045708|NCT00118404|147643793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988|STANDARD_ERROR_OF_MEAN|0.3||0.48|TWO_SIDED|95.0|0.55|1.76|||Log Rank|log-rank chi-square = 0.002, df = 1|Hazard ratio for relapse/recurrence in the C-CT group compared to that in the fluoxetine group.|||1.76|0.55|.48
74045709|NCT00118404|147643793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.31||0.14|TWO_SIDED|95.0|0.39|1.31|||Log Rank|Chi-square = 1.19, df = 1|Hazard ratio of relapse/recurrence in the Fluoxetine arm over the 20 months of follow-up since randomization compared to the pill placebo arm.|||1.31|.39|.14
74045710|NCT00118404|147643793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715|STANDARD_ERROR_OF_MEAN|0.3||0.13|TWO_SIDED|95.0|0.4|1.29|||Log Rank|chi-square = 1.262, df = 1|Hazard ratio of relapse/recurrence in the C-CT arm over the 20 months of follow-up since randomization compared to the pill placebo arm.|||1.29|.40|.13
74045711|NCT00118404|147643793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.26||0.1|TWO_SIDED|95.0|0.43|1.2|||Log Rank|Chi-square = 1.595, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO (placebo)arm.|||1.20|.43|.10
74045712|NCT00118404|147643794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075|STANDARD_ERROR_OF_MEAN|0.27||0.4|TWO_SIDED|95.0|0.63|1.84|||Log Rank|chi-square = .07, df = 1|Hazard of relapse/recurrence for C-CT arm compared to FLX arm was reported.|||1.84|.63|.40
74045713|NCT00118404|147643794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.649|STANDARD_ERROR_OF_MEAN|0.28||0.61|TWO_SIDED|95.0|0.37|1.13|||Log Rank|chi-square = 2.407, df = 1|Hazard of relapse/recurrence in the FLX arm compared tp C-CT arm was reported.|||1.13|.37|.61
74045714|NCT00118404|147643794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.701|STANDARD_ERROR_OF_MEAN|0.27||0.09|TWO_SIDED|95.0|0.41|1.19|||Log Rank|chi-square = 1.731, df = 1|Hazard of relapse/recurrence in the C-CT arm compared to PBO arm is reported.|||1.19|.41|.09
74045715|NCT00118404|147643794|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.676|STANDARD_ERROR_OF_MEAN|0.24||0.05|TWO_SIDED|95.0|0.42|1.08|||Log Rank|chi-square = 2.705, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO arm was reported.|||1.08|.42|.05
74045716|NCT00499460|147643795|SUPERIORITY|The primary hypothesis being tested is that garlic powder treatment increases metabolic clearance of oxycodone through enzyme induction and results in lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is oxycodone oral clearance. Explanatory variables include treatment, period and gender, along with their interaction terms.||||||>0.05
74045717|NCT00499460|147643796|SUPERIORITY|The secondary hypothesis being tested is that powder garlic treatment lowers Cold Pressor Test tolerance (i.e., diminished analgesic response) after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is log Tolerance AUC. Explanatory variables include treatment, period and gender, along with their interaction terms.||||||>0.05
74045718|NCT00499460|147643797|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total SSE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.||||||>0.05
74045719|NCT00499460|147643798|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total CASE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.||||||>0.05
74045720|NCT00499460|147643799|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo||The secondary hypothesis being tested is that garlic powder induces CYP3A-mediated metabolism resulting in a lower oral midazolam AUC.||||>0.05
74045721|NCT00499460|147643800|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment induces intestinal P-glycoprotein, reduces the bioavailability and hence AUC of orally administered digoxin.|||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo||||||>0.05
74045722|NCT01256918|147643802|SUPERIORITY_OR_OTHER||incidence|0.0|||>|0.05|||||||incidence|||"Any occurence of posterior capsular rupture in attempted vertical chop would have been an indicator of overzealous penetration as the vertical chop even though effective would not have been safe.~We hypothesised that use of callibrated phacotip after careful preoperative assessment for performing vertical chop during phacoemulsification is not associated with any posterior capsular rupture we noted any incidence of posterior capsular rupture."||||>0.05
74045723|NCT01256918|147643803|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.850958|||<|0.05|||||||pearson correlation coefficient|||null hypothesis : there is no correlation between nuclear colour and phacodepth required for a full thickness crack during a vertical chop||||<0.05
74045724|NCT01256918|147643804|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.842617|||<|0.05|||||||pearson correlation coefficient|||"Null hypothesis:~there is no correlation between nuclear opalescence and phacodepth required to achieve full thickness nuclear crack using a callibrated phacotip."||||<0.05
74016734|NCT01978093|147584964|NON_INFERIORITY|Lower limit of the two-sided standardized asymptotic 97.5% CI on the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-HAV concentrations ≥15 mIU/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.0|||||TWO_SIDED|97.5|-3.76|3.91|||Group difference in proportions||To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix \& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|Difference between HibCY and PedHIB groups in percentage of subjects with anti-HAV concentrations equal to or above the cut-off value of 15 mIU/mL one month after the second Havrix dose.||3.91|-3.76|
74016735|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||TWO_SIDED|97.5|1.04|1.51|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the fourth dose||1.51|1.04|
74016736|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.01|||||TWO_SIDED|97.5|0.83|1.24|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the fourth dose||1.24|0.83|
74016737|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.1|||||TWO_SIDED|97.5|0.92|1.31|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the fourth dose||1.31|0.92|
74016738|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.06|||||TWO_SIDED|97.5|0.87|1.28|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the fourth dose||1.28|0.87|
74016739|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.21|||||TWO_SIDED|97.5|1.01|1.44|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the fourth dose||1.44|1.01|
74016740|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.13|||||TWO_SIDED|97.5|0.94|1.36|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the fourth dose||1.36|0.94|
74016741|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||TWO_SIDED|97.5|0.93|1.29|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the fourth dose||1.29|0.93|
74045725|NCT01256918|147643805|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.111166|||>|0.05|||||||pearson correlation coefficient|||null hypothesis there is no correlation between lens thickness and penetration of phacotip (phacodepth)required to achieve full thickness crack in vertical chop during phacoemulsification||||>0.05
74045726|NCT04315298|147643819|SUPERIORITY||LS Mean (log scale)|-1.25|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-1.456|-1.035||P-value is based on the ANCOVA model for differences between treatment groups in terms of \[ln(CRP at day 4 ) - ln(baseline CRP)\].|ANCOVA|||||-1.035|-1.456|<0.0001
73888058|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.4358|TWO_SIDED|95.0|-10.5|24.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.2|-10.5|0.4358
73888059|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7||||0.1789|TWO_SIDED|95.0|-5.4|28.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.9|-5.4|0.1789
74045727|NCT04315298|147643819|SUPERIORITY||LS Mean (log scale)|-1.3|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-1.511|-1.09||p-value is based on the ANCOVA model for differences between treatment groups in terms of \[ln(CRP at day 4 ) - ln(baseline CRP)\].|ANCOVA|||||-1.090|-1.511|<0.0001
74045728|NCT04315298|147643820|SUPERIORITY||Risk Difference (RD)|7.1||||0.3707|TWO_SIDED|95.0|-8.4|21.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||21.7|-8.4|0.3707
74045729|NCT04315298|147643820|SUPERIORITY||Risk Difference (RD)|7.5||||0.3261|TWO_SIDED|95.0|-7.4|21.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||21.3|-7.4|0.3261
74045730|NCT04315298|147643821|SUPERIORITY||Risk Difference (RD)|6.2||||0.7328|TWO_SIDED|95.0|-26.2|36.8|||Cochran-Mantel-Haenszel|P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline||||36.8|-26.2|0.7328
74045731|NCT04315298|147643822|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.5687|TWO_SIDED|95.0|0.76|1.66||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.66|0.76|0.5687
74045732|NCT04315298|147643822|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7014|TWO_SIDED|95.0|0.74|1.62||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.62|0.74|0.7014
74045733|NCT04315298|147643823|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3622|TWO_SIDED|95.0|0.83|1.7||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.70|0.83|0.3622
74045734|NCT04315298|147643823|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.5802|TWO_SIDED|95.0|0.79|1.63||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.63|0.79|0.5802
74045735|NCT04315298|147643824|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.234|TWO_SIDED|95.0|0.83|2.02||P-value based on log-rank test stratified by disease severity (severe, critical and MSOD) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.02|0.83|0.2340
74045736|NCT04315298|147643824|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.6949|TWO_SIDED|95.0|0.74|1.79||P-value based on log-rank test stratified by disease severity (severe, critical and MSOD) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.79|0.74|0.6949
74045737|NCT04315298|147643825|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.3151|TWO_SIDED|95.0|0.66|2.43||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||2.43|0.66|0.3151
74045738|NCT04315298|147643825|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.1884|TWO_SIDED|95.0|0.39|1.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.41|0.39|0.1884
74045739|NCT04315298|147643825|SUPERIORITY||Hazard Ratio (HR)|1.61||||0.4356|TWO_SIDED|95.0|0.76|3.4||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||3.40|0.76|0.4356
74045740|NCT04315298|147643825|SUPERIORITY||Hazard Ratio (HR)|2.1||||0.0371|TWO_SIDED|95.0|1.01|4.4||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||4.40|1.01|0.0371
74045741|NCT04315298|147643825|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8923|TWO_SIDED|95.0|0.32|3.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||3.05|0.32|0.8923
74045742|NCT04315298|147643825|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.694|TWO_SIDED|95.0|0.25|2.71||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.71|0.25|0.6940
74045743|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|2.14||||0.0832|TWO_SIDED|95.0|0.81|5.65||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)||5.65|0.81|0.0832
74045744|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|1.93||||0.1369|TWO_SIDED|95.0|0.77|4.8||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)||4.80|0.77|0.1369
74045745|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.9636|TWO_SIDED|95.0|0.28|1.95||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)||1.95|0.28|0.9636
74045746|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0038|TWO_SIDED|95.0|0.08|0.74||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)||0.74|0.08|0.0038
74045747|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.738|TWO_SIDED|95.0|0.47|3.13||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 166.68pg/mL (Median)||3.13|0.47|0.7380
74045748|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.7342|TWO_SIDED|95.0|0.48|3.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \<166.68pg/mL (Median)||3.05|0.48|0.7342
74045749|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|3.58||||0.1934|TWO_SIDED|95.0|0.79|16.17||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)||16.17|0.79|0.1934
74045750|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|5.33||||0.0159|TWO_SIDED|95.0|1.19|23.94||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)||23.94|1.19|0.0159
74045751|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.6281|TWO_SIDED|95.0|0.13|8.75||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)||8.75|0.13|0.6281
74016742|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||TWO_SIDED|97.5|0.94|1.33|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the fourth dose||1.33|0.94|
74016743|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.96|1.41|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the fourth dose||1.41|0.96|
74016744|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.14|||||TWO_SIDED|97.5|0.97|1.35|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the fourth dose||1.35|0.97|
74016745|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||TWO_SIDED|97.5|0.9|1.31|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the fourth dose||1.31|0.90|
74045752|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.4971|TWO_SIDED|95.0|0.06|6.13||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)||6.13|0.06|0.4971
74045753|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.299|TWO_SIDED|95.0|0.03|2.86||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)||2.86|0.03|0.2990
74095869|NCT00593736|147741422|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.362
74045754|NCT04315298|147643826|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.936|TWO_SIDED|95.0|0.22|4.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)||4.41|0.22|0.9360
74045755|NCT04315298|147643827|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.9032|TWO_SIDED|95.0|0.52|1.47||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.47|0.52|0.9032
74045756|NCT04315298|147643827|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0052|TWO_SIDED|95.0|0.29|0.88||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||0.88|0.29|0.0052
74045757|NCT04315298|147643827|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.1168|TWO_SIDED|95.0|0.48|1.21||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.21|0.48|0.1168
74045758|NCT04315298|147643827|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3753|TWO_SIDED|95.0|0.69|1.72||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.72|0.69|0.3753
74045759|NCT04315298|147643827|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4956|TWO_SIDED|95.0|0.4|1.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.66|0.40|0.4956
74045760|NCT04315298|147643827|SUPERIORITY||Cox Proportional Hazard|1.01||||0.8439|TWO_SIDED|95.0|0.5|2.02||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.02|0.50|0.8439
74045761|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.389|TWO_SIDED|95.0|0.52|2.79||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)||2.79|0.52|0.3890
74045762|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.7838||95.0|0.3|1.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)||1.41|0.30|0.7838
74095870|NCT00593736|147741423|SUPERIORITY_OR_OTHER|||||||0.684||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.684
74095871|NCT00593736|147741423|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.399
74016746|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB Group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||TWO_SIDED|97.5|0.95|1.34|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the fourth dose||1.34|0.95|
73880455|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|0.68||||0.5881|TWO_SIDED|95.0|0.16|2.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.78|0.16|0.5881
74016747|NCT01978093|147584965|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.22|||||TWO_SIDED|97.5|1.0|1.5|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the fourth dose||1.50|1.00|
74016748|NCT01202656|147585027|SUPERIORITY_OR_OTHER|||||||0.72|||||||Cochran-Mantel-Haenszel|||||||0.72
74016749|NCT00493038|147585029|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|2.1||||||95.0|-1.9|6.2|||||Mean difference denotes the difference of clinical cure rates between the two treatment groups (moxifloxacin minus amoxicillin/clavulanate).|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.2|-1.9|
74016750|NCT00493038|147585030|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|-0.5||||||95.0|-7.9|6.8||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.8|-7.9|
74016751|NCT00493038|147585031|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|1.7||||||95.0|-3.8|7.1||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.1|-3.8|
74016752|NCT01100944|147585047|SUPERIORITY_OR_OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
74016753|NCT01100944|147585056|SUPERIORITY_OR_OTHER|||||||0.3||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. Only differences with p\<0.005 could be potentially considered statistically significant while those with 0.005\<p\<0.05 would represent trends towards a difference.|Wilcoxon signed rank test|||||||0.30
74016754|NCT01100944|147585056|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
74016755|NCT01100944|147585056|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
74016756|NCT01100944|147585057|SUPERIORITY_OR_OTHER|||||||0.76||||||Fold change at Cycle 2 Day 1 vs. pre was assessed.Only differences with p\<0.005 could be potentially considered statistically significant while those with 0.005\<p\<0.05 would represent trends towards a difference.|Wilcoxon signed rank test|||||||0.76
74016757|NCT01100944|147585057|SUPERIORITY_OR_OTHER|||||||0.0009||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0009
74045763|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.237|TWO_SIDED|95.0|0.28|1.65||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)||1.65|0.28|0.2370
74045764|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|0.25||||0.0004||95.0|0.1|0.59||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)||0.59|0.10|0.0004
74016758|NCT01100944|147585057|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
74045765|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.174|TWO_SIDED|95.0|0.37|1.32||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)||1.32|0.37|0.1740
73880456|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|0.11||||0.0523|TWO_SIDED|95.0|0.01|1.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.02|0.01|0.0523
73880457|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.6||||0.4646|TWO_SIDED|95.0|0.46|5.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.61|0.46|0.4646
73880458|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|1.43||||0.5806|TWO_SIDED|95.0|0.4|5.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.14|0.40|0.5806
73880459|NCT03192176|147297622|SUPERIORITY||Odds Ratio (OR)|0.94||||0.922|TWO_SIDED|95.0|0.28|3.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.12|0.28|0.9220
73880460|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|4.45||||0.1933|TWO_SIDED|95.0|0.47|42.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||42.25|0.47|0.1933
73880461|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|5.61||||0.124|TWO_SIDED|95.0|0.62|50.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||50.44|0.62|0.1240
74016759|NCT01100944|147585058|SUPERIORITY_OR_OTHER|||||||0.95||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.95
74016760|NCT01100944|147585058|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
74016761|NCT01100944|147585058|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
74016762|NCT01175902|147585059|NON_INFERIORITY_OR_EQUIVALENCE|"To prove the non-inferiority of Cosopt to Xalatan, the sample size calculation was based on the assumption that non-inferiority margin of trough IOP of 1.5mmHg. A sample size of n=21 patients per group, this study has 80% power (1-β=0.80) and α=0.05, crossover-designed analysis.~In this study, the upper limit of the 95% CI is expected above the maximal acceptable clinically significant difference of 1.5 mmHg of IOP."|Mean Difference (Final Values)|0.9||||0.05|TWO_SIDED|||||Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|t-test, 2 sided|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.||||0.05
73880462|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|14.16||||0.014|TWO_SIDED|95.0|1.71|117.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||117.2|1.71|0.0140
73880463|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|17.5||||0.0075|TWO_SIDED|95.0|2.15|142.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||142.7|2.15|0.0075
73880464|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.98||||0.5853|TWO_SIDED|95.0|0.17|22.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.96|0.17|0.5853
73880465|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|5.0||||0.1596|TWO_SIDED|95.0|0.53|47.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||47.05|0.53|0.1596
74016763|NCT00699907|147585065|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon Rank Sum Test|||||||0.012
74016764|NCT00699907|147585065|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
74016765|NCT00699907|147585066|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon Rank Sum Test|||||||0.010
73880466|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|6.48||||0.0908|TWO_SIDED|95.0|0.74|56.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||56.51|0.74|0.0908
73880467|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.97||||0.1318|TWO_SIDED|95.0|0.72|12.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.19|0.72|0.1318
73880468|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0093|TWO_SIDED|95.0|1.56|23.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||23.04|1.56|0.0093
73888060|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|14.0||||0.1131|TWO_SIDED|95.0|-3.3|31.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.3|-3.3|0.1131
73880469|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|10.13||||0.0006|TWO_SIDED|95.0|2.69|38.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||38.22|2.69|0.0006
73880470|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|15.63|||<|0.0001|TWO_SIDED|95.0|4.11|59.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||59.40|4.11|<0.0001
73880471|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.53||||0.2054|TWO_SIDED|95.0|0.6|10.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.64|0.60|0.2054
73880472|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.8||||0.1592|TWO_SIDED|95.0|0.67|11.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.72|0.67|0.1592
73880473|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|6.31||||0.007|TWO_SIDED|95.0|1.66|24.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||24.07|1.66|0.0070
73880474|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0392|TWO_SIDED|95.0|1.06|10.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.85|1.06|0.0392
74016766|NCT00699907|147585066|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
73880475|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|4.49||||0.0096|TWO_SIDED|95.0|1.44|13.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.96|1.44|0.0096
73880476|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|10.11|||<|0.0001|TWO_SIDED|95.0|3.28|31.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||31.16|3.28|<0.0001
73880477|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|11.76|||<|0.0001|TWO_SIDED|95.0|3.75|36.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.90|3.75|<0.0001
73880478|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.11||||0.2217|TWO_SIDED|95.0|0.64|7.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.03|0.64|0.2217
73880479|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|4.26||||0.0131|TWO_SIDED|95.0|1.36|13.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.38|1.36|0.0131
73880480|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0031|TWO_SIDED|95.0|1.76|16.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.46|1.76|0.0031
74016767|NCT00699907|147585067|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Wilcoxon Rank Sum Test|||||||0.0006
74016768|NCT00699907|147585067|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
74016769|NCT00699907|147585068|SUPERIORITY_OR_OTHER|||||||0.009|||||||Wilcoxon Rank Sum Test|||||||0.009
74016770|NCT00699907|147585068|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
74016771|NCT00699907|147585069|SUPERIORITY_OR_OTHER|||||||0.037|||||||Wilcoxon Rank Sum Test|||||||0.037
73880481|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.15||||0.1485|TWO_SIDED|95.0|0.76|6.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.10|0.76|0.1485
73880482|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0128|TWO_SIDED|95.0|1.31|9.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.56|1.31|0.0128
73880483|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|6.5||||0.0003|TWO_SIDED|95.0|2.37|17.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||17.81|2.37|0.0003
73880484|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0003|TWO_SIDED|95.0|2.32|17.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||17.77|2.32|0.0003
73880485|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.87||||0.2354|TWO_SIDED|95.0|0.67|5.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.26|0.67|0.2354
74016772|NCT00699907|147585069|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
73880486|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0894|TWO_SIDED|95.0|0.87|6.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.65|0.87|0.0894
74016773|NCT00699907|147585070|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon Rank Sum Test|||||||0.010
74016774|NCT00699907|147585070|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
74016775|NCT00699907|147585071|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
74016776|NCT00699907|147585071|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
74016777|NCT00699907|147585072|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon Rank Sum Test|||||||0.006
74016778|NCT00699907|147585072|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
74016779|NCT00699907|147585073|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||||||<0.0001
74016780|NCT00699907|147585073|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
74016781|NCT02161211|147585074|SUPERIORITY|||||||0.673|||||||Chi-squared|df = 2||Null hypothesis = no difference in frequency in relapse between groups||||.673
74016782|NCT02161211|147585075|SUPERIORITY||Wald Chi-squared|-0.278||||0.133|TWO_SIDED|95.0|-0.64|0.084|||Wald Chi-squared|Negative binomial regression with offset of natural log of possible drinking days||||.084|-.64|.133
74045766|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3664|TWO_SIDED|95.0|0.38|1.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)||1.66|0.38|0.3664
74045767|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7318|TWO_SIDED|95.0|0.53|1.87||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)||1.87|0.53|0.7318
73880487|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.23||||0.0201|TWO_SIDED|95.0|1.2|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.67|1.20|0.0201
74016783|NCT02161211|147585075|SUPERIORITY||Wald Chi-squared|0.101||||0.562|TWO_SIDED|95.0|-0.24|0.44|||Wald Chi-squared|||||.44|-.24|.562
74016784|NCT02161211|147585076|SUPERIORITY|||||||0.982|||||||ANOVA|F(2,105) = .019||||||.982
74016785|NCT02161211|147585077|SUPERIORITY|||||||0.685|||||||Chi-squared|||Null hypothesis = no difference in proportion between the groups||||.685
74016786|NCT02161211|147585078|SUPERIORITY|||||||0.608|||||||Chi-squared|||Null hypothesis = no significant difference in frequency of hazardous drinking between groups||||.608
74016787|NCT03850912|147585118|SUPERIORITY||Odds Ratio (OR)|1.104||||0.214|TWO_SIDED|95.0|0.944|1.29|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (chemo and surgical patients combined)||1.290|0.944|0.214
74016788|NCT03850912|147585118|SUPERIORITY||Odds Ratio (OR)|0.927||||0.565|TWO_SIDED|95.0|0.715|1.201|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.201|0.715|0.565
74016789|NCT03850912|147585118|SUPERIORITY||Odds Ratio (OR)|1.225||||0.042|TWO_SIDED|95.0|1.008|1.49|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.490|1.008|0.042
74016790|NCT03850912|147585119|OTHER||Odds Ratio (OR)|1.128||||0.05|TWO_SIDED|95.0|1.0|1.272|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.272|1.000|0.050
74016791|NCT03850912|147585119|OTHER||Odds Ratio (OR)|1.012||||0.903|TWO_SIDED|95.0|0.836|1.225|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.225|0.836|0.903
74016792|NCT03850912|147585119|OTHER||Odds Ratio (OR)|1.215||||0.014|TWO_SIDED|95.0|1.04|1.418|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.418|1.040|0.014
74016793|NCT03850912|147585120|OTHER||Odds Ratio (OR)|1.002||||0.978|TWO_SIDED|95.0|0.881|1.139|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.139|0.881|0.978
74016794|NCT03850912|147585120|OTHER||Odds Ratio (OR)|0.854||||0.126|TWO_SIDED|95.0|0.697|1.046|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.046|0.697|0.126
74016795|NCT03850912|147585120|OTHER||Odds Ratio (OR)|1.102||||0.254|TWO_SIDED|95.0|0.933|1.302|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.302|0.933|0.254
74016796|NCT03850912|147585121|OTHER||Odds Ratio (OR)|1.068||||0.209|TWO_SIDED|95.0|0.964|1.183|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.183|0.964|0.209
74016797|NCT03850912|147585121|OTHER||Odds Ratio (OR)|0.992||||0.924|TWO_SIDED|95.0|0.85|1.159|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.159|0.850|0.924
74016798|NCT03850912|147585121|OTHER||Odds Ratio (OR)|1.122||||0.099|TWO_SIDED|95.0|0.979|1.286|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.286|0.979|0.099
74016799|NCT03850912|147585122|SUPERIORITY||Difference|-1.328||||0.04|TWO_SIDED|95.0|-2.593|-0.062|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||-0.062|-2.593|0.04
74016800|NCT03850912|147585122|OTHER||Difference|-1.958||||0.004|TWO_SIDED|95.0|-3.269|-0.646|||Regression, Logistic|||Multivariable regression analyses (surgical cohort only)||-0.646|-3.269|0.004
74016801|NCT03850912|147585123|SUPERIORITY||Difference|-0.925||||0.09|TWO_SIDED|95.0|-1.985|0.136|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.136|-1.985|0.09
74045768|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4155|TWO_SIDED|95.0|0.59|2.37||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)||2.37|0.59|0.4155
74016802|NCT03850912|147585123|SUPERIORITY||Difference|-1.516||||0.002|TWO_SIDED|95.0|-2.474|-0.557|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||-0.557|-2.474|0.002
74016803|NCT03850912|147585124|SUPERIORITY||Difference|-1.767||||0.17|TWO_SIDED|95.0|-2.532|0.433|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.433|-2.532|0.17
74016804|NCT03850912|147585124|SUPERIORITY||Difference|-2.198|||<|0.0001|TWO_SIDED|95.0|-3.259|-1.137|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||-1.137|-3.259|<0.0001
74016805|NCT03850912|147585125|SUPERIORITY||Difference|-0.8084||||0.2|TWO_SIDED|95.0|-2.048|0.431|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.431|-2.048|0.2
74016806|NCT03850912|147585125|SUPERIORITY||Difference|-0.652||||0.27|TWO_SIDED|95.0|-1.8|0.496|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||0.496|-1.800|0.27
74016807|NCT03850912|147585126|SUPERIORITY||Difference|-0.617||||0.23|TWO_SIDED|95.0|-1.62|0.386|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.386|-1.620|0.23
74016808|NCT03850912|147585126|SUPERIORITY||Difference|0.434||||0.39|TWO_SIDED|95.0|-0.563|1.431|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||1.431|-0.563|0.39
74016809|NCT03850912|147585127|SUPERIORITY||Difference|-0.7||||0.22|TWO_SIDED|95.0|-1.829|0.429|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.429|-1.829|0.22
74016810|NCT03850912|147585127|SUPERIORITY||Difference|-0.58||||0.28|TWO_SIDED|95.0|-1.632|0.472|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||0.472|-1.632|0.28
74016811|NCT03850912|147585128|SUPERIORITY||Odds Ratio (OR)|0.842|||<|0.001|TWO_SIDED|95.0|0.776|0.913|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (chemo and surgical patients combined)||0.913|0.776|<0.001
74016812|NCT03850912|147585128|SUPERIORITY||Odds Ratio (OR)|0.78|||<|0.001|TWO_SIDED|95.0|0.688|0.885|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.885|0.688|<0.001
74016813|NCT03850912|147585128|SUPERIORITY||Odds Ratio (OR)|0.889||||0.032|TWO_SIDED|95.0|0.799|0.99|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.990|0.799|0.032
74016814|NCT03850912|147585129|SUPERIORITY||Odds Ratio (OR)|0.893|||<|0.001|TWO_SIDED|95.0|0.839|0.949|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.949|0.839|<0.001
74016815|NCT03850912|147585129|SUPERIORITY||Odds Ratio (OR)|0.872||||0.003|TWO_SIDED|95.0|0.796|0.954|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.954|0.796|0.003
74016816|NCT03850912|147585129|SUPERIORITY||Odds Ratio (OR)|0.909||||0.027|TWO_SIDED|95.0|0.835|0.989|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.989|0.835|0.027
74016817|NCT03850912|147585130|SUPERIORITY||Odds Ratio (OR)|0.636|||<|0.001|TWO_SIDED|95.0|0.593|0.682|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.682|0.593|<0.001
74016818|NCT03850912|147585130|SUPERIORITY||Odds Ratio (OR)|0.611|||<|0.001|TWO_SIDED|95.0|0.55|0.679|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.679|0.550|<0.001
74016819|NCT03850912|147585130|SUPERIORITY||Odds Ratio (OR)|0.655|||<|0.001|TWO_SIDED|95.0|0.597|0.719|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.719|0.597|<0.001
74016820|NCT03850912|147585131|SUPERIORITY||Odds Ratio (OR)|0.769|||<|0.001|TWO_SIDED|95.0|0.729|0.811|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.811|0.729|<0.001
74016821|NCT03850912|147585131|SUPERIORITY||Odds Ratio (OR)|0.795|||<|0.001|TWO_SIDED|95.0|0.737|0.858|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.858|0.737|<0.001
74016822|NCT03850912|147585131|SUPERIORITY||Odds Ratio (OR)|0.739|||<|0.001|TWO_SIDED|95.0|0.686|0.796|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.796|0.686|<0.001
74016823|NCT02301403|147585156|SUPERIORITY||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.69|5.14|||Regression, Logistic|||||5.14|1.69|<.001
74016824|NCT00217087|147585184|SUPERIORITY_OR_OTHER|||||||0.0098|TWO_SIDED||||||Fisher Exact|||||||0.0098
74016825|NCT00217087|147585185|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Chi-squared|||||||0.34
74016826|NCT00217087|147585186|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|the only participant who reported a decrease quality of life related that to a recent surgery not their esophagus.||||||0.2
74016827|NCT03208231|147585187|SUPERIORITY|||||||0.79|||||||Fisher Exact|||||||0.79
73880488|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1614|TWO_SIDED|95.0|0.74|5.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.94|0.74|0.1614
74016828|NCT03208231|147585188|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
73880489|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0123|TWO_SIDED|95.0|1.32|9.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.66|1.32|0.0123
74045769|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.6262|TWO_SIDED|95.0|0.23|2.45||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)||2.45|0.23|0.6262
73880490|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|6.08||||0.0006|TWO_SIDED|95.0|2.17|17.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||17.03|2.17|0.0006
73880491|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|3.4|28.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||28.36|3.40|<0.0001
74016829|NCT01844986|147585222|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.23|<0.0001
74016830|NCT01844986|147585222|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.23|0.97||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \< 1 favours olaparib|||0.97|0.23|
74016831|NCT01844986|147585223|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8903|TWO_SIDED|95.0|0.6|1.53||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||1.53|0.60|0.8903
74016832|NCT01844986|147585223|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.29|2.28||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \< 1 favours olaparib|||2.28|0.29|
74045770|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.553||95.0|0.21|2.3||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)||2.30|0.21|0.5530
74045771|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.8775|TWO_SIDED|95.0|0.25|2.85||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)||2.85|0.25|0.8775
74045772|NCT04315298|147643828|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.7485|TWO_SIDED|95.0|0.41|2.99||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)||2.99|0.41|0.7485
74045773|NCT04315298|147643829|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.4556|TWO_SIDED|95.0|0.63|1.79||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.79|0.63|0.4556
74045774|NCT04315298|147643829|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0248|TWO_SIDED|95.0|0.35|1.04||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.04|0.35|0.0248
74045775|NCT04315298|147643829|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.6842|TWO_SIDED|95.0|0.62|1.67||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.67|0.62|0.6842
74045776|NCT04315298|147643829|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.0671|TWO_SIDED|95.0|0.89|2.32||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.32|0.89|0.0671
74045777|NCT04315298|147643829|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.6146|TWO_SIDED|95.0|0.41|1.74||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.74|0.41|0.6146
74045778|NCT04315298|147643829|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.973|TWO_SIDED|95.0|0.48|1.99||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.99|0.48|0.9730
74045779|NCT04315298|147643831|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.6987|TWO_SIDED|95.0|0.59|1.59||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.59|0.59|0.6987
74045780|NCT04315298|147643831|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0453|TWO_SIDED|95.0|0.39|1.09||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.09|0.39|0.0453
74045781|NCT04315298|147643831|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.9734|TWO_SIDED|95.0|0.73|2.09||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.09|0.73|0.9734
74045782|NCT04315298|147643831|SUPERIORITY||Hazard Ratio (HR)|1.91||||0.004|TWO_SIDED|95.0|1.14|3.2||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No)|Log Rank|||Disease Severity: Critical||3.20|1.14|0.0040
74045783|NCT04315298|147643831|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9551|TWO_SIDED|95.0|0.43|2.17||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.17|0.43|0.9551
74045784|NCT04315298|147643831|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.8722|TWO_SIDED|95.0|0.42|2.1||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.10|0.42|0.8722
74045785|NCT04315298|147643834|SUPERIORITY|||||||1|||||||Chi-squared|||Disease Severity: Severe||||1.0000
74045786|NCT04315298|147643834|SUPERIORITY|||||||0.0353|||||||Chi-squared|||Disease Severity: Severe||||0.0353
74045787|NCT04315298|147643834|SUPERIORITY|||||||0.3187|||||||Chi-squared|||Disease Severity: Critical||||0.3187
74045788|NCT04315298|147643834|SUPERIORITY|||||||0.0261|||||||Chi-squared|||Disease Severity: Critical||||0.0261
74045789|NCT04315298|147643834|SUPERIORITY|||||||0.9117|||||||Chi-squared|||Disease Severity: MSOD||||0.9117
74045790|NCT04315298|147643834|SUPERIORITY|||||||0.7584|||||||Chi-squared|||Disease Severity: MSOD||||0.7584
74045791|NCT04315298|147643838|SUPERIORITY||Hazard Ratio (HR)|0.32||||0.0385|TWO_SIDED|95.0|0.11|0.94||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||0.94|0.11|0.0385
74095872|NCT00593736|147741423|SUPERIORITY_OR_OTHER|||||||0.611||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.611
73880492|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1609|TWO_SIDED|95.0|0.75|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.81|0.75|0.1609
74045792|NCT04315298|147643838|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0782|TWO_SIDED|95.0|0.14|1.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.05|0.14|0.0782
74045793|NCT04315298|147643838|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.2436|TWO_SIDED|95.0|0.7|2.14||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.14|0.70|0.2436
74095873|NCT00593736|147741424|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.157
74095874|NCT00593736|147741424|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.463
74045794|NCT04315298|147643838|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3223|TWO_SIDED|95.0|0.46|1.51||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.51|0.46|0.3223
74045795|NCT04315298|147643838|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.467|TWO_SIDED|95.0|0.36|1.52||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.52|0.36|0.4670
74095875|NCT00593736|147741424|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.774
74045796|NCT04315298|147643838|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.3728|TWO_SIDED|95.0|0.35|1.47||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.47|0.35|0.3728
74045797|NCT04315298|147643844|SUPERIORITY||Risk Difference (RD)|2.7||||0.5851|TWO_SIDED|95.0|-7.0|12.4||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||12.4|-7.0|0.5851
74045798|NCT04315298|147643844|SUPERIORITY||Risk Difference (RD)|-2.6||||0.5767|TWO_SIDED|95.0|-11.7|6.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||6.5|-11.7|0.5767
74045799|NCT04315298|147643845|SUPERIORITY||Risk Difference (RD)|5.2||||0.4777|TWO_SIDED|95.0|-9.4|18.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.6|-9.4|0.4777
74045800|NCT04315298|147643845|SUPERIORITY||Risk Difference (RD)|5.7||||0.4202|TWO_SIDED|95.0|-8.4|18.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.2|-8.4|0.4202
74045801|NCT04315298|147643846|SUPERIORITY||Risk Difference (RD)|0.2||||0.9696|TWO_SIDED|95.0|-9.5|9.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||9.9|-9.5|0.9696
74045802|NCT04315298|147643846|SUPERIORITY||Risk Difference (RD)|-4.7||||0.3152|TWO_SIDED|95.0|-13.8|4.4||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.4|-13.8|0.3152
74016833|NCT01844986|147585224|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.23|<0.0001
74095876|NCT00593736|147741425|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.413
74095877|NCT00593736|147741425|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.093
73880493|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.42||||0.093|TWO_SIDED|95.0|0.86|6.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.79|0.86|0.0930
73880494|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0063|TWO_SIDED|95.0|1.48|10.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.91|1.48|0.0063
74016834|NCT01844986|147585224|SUPERIORITY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.23|0.99||Not applicable due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||0.99|0.23|
74016835|NCT01844986|147585225|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0002|TWO_SIDED|95.0|0.35|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.72|0.35|0.0002
74016836|NCT01844986|147585225|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.23|1.35||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.35|0.23|
74016837|NCT01844986|147585226|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.001|TWO_SIDED|95.0|-4.779|-1.216|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.||||-1.216|-4.779|0.0010
74016838|NCT01844986|147585227|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
74016839|NCT01844986|147585227|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.29|1.23||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.23|0.29|
74016840|NCT01844986|147585228|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.32|0.63||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.63|0.32|<0.0001
74016841|NCT01844986|147585228|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.25|1.26||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.26|0.25|
74016842|NCT01844986|147585229|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.51|0.79||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.79|0.51|<0.0001
74016843|NCT01844986|147585229|SUPERIORITY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.47|1.42||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.42|0.47|
74016844|NCT01844986|147585230|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
74016845|NCT06523491|147585231|SUPERIORITY||F value|23.31||||0|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of 1 and 2 NOLTREX courses with placebo was used ANCOVA adjusted for the baseline value with fixed factor of treatment group"||No sample size calculation was performed. In the survey took part 57 patients from the parent study and OLE. The study did not have a formal hypothesis. The between-group comparison of changes from baseline (OLE visit 0) in the WOMAC-T at the end of 12-month follow-up (EOF) visit was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.00
74016846|NCT06523491|147585231|SUPERIORITY||LS-means difference|353.18|STANDARD_ERROR_OF_MEAN|72.27||0|TWO_SIDED|95.0|178.91|527.45||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||527.45|178.91|0.00
74016847|NCT06523491|147585231|SUPERIORITY||LS-means difference|-292.19|STANDARD_ERROR_OF_MEAN|78.04||0|TWO_SIDED|95.0|-480.37|-104.01||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-104.01|-480.37|0.00
74016848|NCT06523491|147585231|SUPERIORITY||LS-means difference|-645.37|STANDARD_ERROR_OF_MEAN|95.68||0|TWO_SIDED|95.0|-876.07|-414.67||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-414.67|-876.07|0.00
74016849|NCT06523491|147585231|SUPERIORITY||F value|23.31||||0|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of 1 and 2 NOLTREX courses with placebo was used ANCOVA adjusted for the baseline value with fixed factor of treatment group"||The between-group comparison of changes from baseline (study 1 visit 1) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.00
74016850|NCT06523491|147585231|SUPERIORITY||LS-means difference|-292.19|STANDARD_ERROR_OF_MEAN|78.04||0|TWO_SIDED|95.0|-480.37|-104.01|||Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-104.01|-480.37|0.00
74016851|NCT06523491|147585231|SUPERIORITY||[LS-means difference|-645.37|STANDARD_ERROR_OF_MEAN|95.68||0|TWO_SIDED|95.0|-876.07|-414.67||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-414.67|-876.07|0.00
74016852|NCT03266016|147585236|SUPERIORITY||Odds Ratio (OR)|1.67||||0.045|TWO_SIDED|95.0|1.01|2.77|||Proportional Odds Logistic Regression|||This analysis is comparing length of weaning between REDvent acute group and control acute group.||2.77|1.01|.045
74016853|NCT03266016|147585236|SUPERIORITY||Proportional odds logistic regression|1.3|||||TWO_SIDED|95.0|0.7|2.6||||||Weaning Phase||2.6|0.7|
74045803|NCT04315298|147643847|SUPERIORITY||Risk Difference (RD)|-7.7||||0.3217|TWO_SIDED|95.0|-22.8|7.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||7.2|-22.8|0.3217
74045804|NCT04315298|147643847|SUPERIORITY||Risk Difference (RD)|-5.5||||0.463|TWO_SIDED|95.0|-20.2|8.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||8.7|-20.2|0.4630
74095878|NCT00593736|147741425|SUPERIORITY_OR_OTHER|||||||0.982||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.982
74095879|NCT00593736|147741426|SUPERIORITY_OR_OTHER|||||||0.441||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.441
74016854|NCT03266016|147585237|SUPERIORITY||Incident rate ratio|1.03|||||TWO_SIDED|95.0|0.84|1.25|||||Negative binomial model.|||1.25|0.84|
74016855|NCT03266016|147585238|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.7||||||||2.7|0.4|
74016856|NCT03266016|147585239|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.44|2.47||||||||2.47|0.44|
74016857|NCT03266016|147585240|SUPERIORITY||Proportional odds logistic regression|1.6|||||TWO_SIDED|95.0|1.01|2.55||||||||2.55|1.01|
74016858|NCT04183335|147585243|SUPERIORITY||Odds Ratio (OR)|6.5|||<|0.0001|TWO_SIDED|95.0|2.78|15.41||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when primary outcome measure was statistically significant at two-sided 0.05.||15.41|2.78|<0.0001
74045805|NCT04315298|147643847|SUPERIORITY||Risk Difference (RD)|-13.3||||0.0971|TWO_SIDED|95.0|-28.2|2.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.3|-28.2|0.0971
74045806|NCT04315298|147643847|SUPERIORITY||Risk Difference (RD)|-11.9||||0.1193|TWO_SIDED|95.0|-26.4|2.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.9|-26.4|0.1193
74045807|NCT04315298|147643848|SUPERIORITY||Risk Difference (RD)|-0.6||||0.8844|TWO_SIDED|95.0|-9.3|7.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||7.7|-9.3|0.8844
74045808|NCT04315298|147643848|SUPERIORITY||Risk Difference (RD)|5.2||||0.2247|TWO_SIDED|95.0|-3.3|13.0||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||13.0|-3.3|0.2247
74045809|NCT04315298|147643848|SUPERIORITY||Risk Difference (RD)|-13.3||||0.2102|TWO_SIDED|95.0|-28.2|2.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.3|-28.2|0.2102
74016859|NCT04183335|147585244|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0004|TWO_SIDED|95.0|1.81|8.98||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||8.98|1.81|0.0004
74016860|NCT04183335|147585245|SUPERIORITY||Odds Ratio (OR)|6.9|||<|0.0001|TWO_SIDED|95.0|2.49|19.05||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||19.05|2.49|<0.0001
74016861|NCT04183335|147585246|SUPERIORITY||LS mean difference|-26.67|||<|0.0001|TWO_SIDED|95.0|-38.44|-14.9||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-14.90|-38.44|<0.0001
74016862|NCT04183335|147585247|SUPERIORITY||Least square mean difference|-6.19|||<|0.0001|TWO_SIDED|95.0|-8.34|-4.05||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-4.05|-8.34|<0.0001
74016863|NCT04183335|147585248|SUPERIORITY||Least square mean difference|-2.17|||<|0.0001|TWO_SIDED|95.0|-3.07|-1.28||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-1.28|-3.07|<0.0001
74016864|NCT04183335|147585249|SUPERIORITY||Least square mean difference|-2.6||||0.0082|TWO_SIDED|95.0|-4.52|-0.67||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-0.67|-4.52|0.0082
74016865|NCT04183335|147585257|SUPERIORITY||LS mean difference|-0.7||||0.0119|TWO_SIDED|95.0|-1.25|-0.15||Threshold of significance at \<0.05 level.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|||-0.15|-1.25|0.0119
74016866|NCT00741156|147585279|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.09
74016867|NCT01449708|147585286|SUPERIORITY_OR_OTHER||Relative Risk|1.27||||0.04|TWO_SIDED|95.0|1.01|1.61|||Chi-squared|||||1.61|1.01|0.04
74016868|NCT01449708|147585288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.04||||0.009|TWO_SIDED|95.0|1.28|7.29|||Chi-squared|||Grouping of surgical procedures into three categories, analysis using bonferroni correction, 1) ReY group( gastric bypass, conversion to gastric bypass and revision gastric bypass) 2) Gastric Band (GB), 3) sleeve gastrectomy (SG)||7.29|1.28|0.009
74016869|NCT02653768|147585306|OTHER|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-5.1|||||TWO_SIDED|95.0|-8.2|-2.0||||||This analysis of between-group difference in change from baseline to 3-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.||-2.0|-8.2|
74016870|NCT02653768|147585306|OTHER|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-5.2|2.3||||||This is the analysis of between-group difference in change from baseline to 6-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.||2.3|-5.2|
74016871|NCT02653768|147585306|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0003|TWO_SIDED|95.0|-10.5|-3.2|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 9-month follow-up. This is the primary outcome assessment time point.||-3.2|-10.5|0.0003
74016872|NCT02653768|147585307|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.43|TWO_SIDED|95.0|-0.6|1.3|||Mixed Models Analysis|||This is the analysis between-group difference in change from baseline to 9-month follow-up for the 30 second chair stand.||1.3|-0.6|0.43
74016873|NCT02653768|147585308|OTHER||Mean Difference (Final Values)|-2.3||||0.23|TWO_SIDED|95.0|-6.1|1.5|||Mixed Models Analysis|||||1.5|-6.1|0.23
74016874|NCT01784965|147585309|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74016875|NCT03823391|147585327|SUPERIORITY||Least Squares (LS) Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.215||0.022|TWO_SIDED|90.0|-0.89|-0.15|||Mixed-effect model repeated measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Between groups difference was a single-arm comparison of LS mean of ABBV-3373 estimated from the MMRM model above minus the historical mean of adalimumab (-2.13).|Two primary comparisons were performed between ABBV-3373 and adalimumab. The first was the comparison of ABBV-3373 to historical adalimumab reference value -2.13 based on a meta-analysis consisting of 242 subjects from 3 historical adalimumab studies in which the success criterion was 2-sided P value ≤ 0.1.||-0.15|-0.89|0.022
74016876|NCT03823391|147585327|SUPERIORITY|||||||0.899||||||Posterior probability|Historical data borrowing|Based on posterior distribution of means for each group, the probability of Treatment mean - Control mean \< 0 given the observed data was calculated.||The second comparison was ABBV-3373 to adalimumab with combined in-trial and borrowed historical adalimumab data using a Bayesian historical borrowing approach in which the success criterion was posterior probability of ABBV-3373 being better than adalimumab \> 95%. When borrowing 30 historical adalimumab subjects, the combined least squares mean change from Baseline was -2.29.||||0.899
74016877|NCT03823391|147585327|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.353||0.683|TWO_SIDED|90.0|-0.74|0.45|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|The mean difference in change from Baseline in DAS28 (CRP) at Week 12 between ABBV-3373 and adalimumab was also estimated only based on in-study data.||0.45|-0.74|0.683
74045810|NCT04315298|147643848|SUPERIORITY||Risk Difference (RD)|-11.9||||0.8292|TWO_SIDED|95.0|-26.4|2.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.9|-26.4|0.8292
74045811|NCT04315298|147643849|SUPERIORITY||Risk Difference (RD)|9.8||||0.2203|TWO_SIDED|95.0|-6.0|24.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||24.3|-6.0|0.2203
74045812|NCT04315298|147643849|SUPERIORITY||Risk Difference (RD)|8.8||||0.2483|TWO_SIDED|95.0|-6.1|22.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||22.6|-6.1|0.2483
74045813|NCT04315298|147643850|SUPERIORITY||Risk Difference (RD)|4.1||||0.602|TWO_SIDED|95.0|-11.2|18.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.5|-11.2|0.6020
74045814|NCT04315298|147643850|SUPERIORITY||Risk Difference (RD)|5.9||||0.4342|TWO_SIDED|95.0|-8.9|19.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||19.5|-8.9|0.4342
74045815|NCT04315298|147643851|SUPERIORITY||Risk Difference (RD)|5.2||||0.2896|TWO_SIDED|95.0|-4.3|14.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||14.7|-4.3|0.2896
74045816|NCT04315298|147643851|SUPERIORITY||Risk Difference (RD)|-2.9||||0.5355|TWO_SIDED|95.0|-11.8|6.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||6.2|-11.8|0.5355
74045817|NCT04315298|147643852|SUPERIORITY||Risk Difference (RD)|0.5||||0.921|TWO_SIDED|95.0|-9.2|10.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.2|-9.2|0.9210
74045818|NCT04315298|147643852|SUPERIORITY||Risk Difference (RD)|-4.7||||0.3174|TWO_SIDED|95.0|-13.8|4.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.5|-13.8|0.3174
74045819|NCT04315298|147643853|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.0705|TWO_SIDED|95.0|0.98|2.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.66|0.98|0.0705
74045820|NCT04315298|147643853|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.18|TWO_SIDED|95.0|0.92|2.43||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.43|0.92|0.1800
74045821|NCT04315298|147643854|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.1831|TWO_SIDED|95.0|0.91|1.52||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.52|0.91|0.1831
74045822|NCT04315298|147643854|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.877|TWO_SIDED|95.0|0.82|1.34||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.34|0.82|0.8770
74045823|NCT04315298|147643855|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.7103|TWO_SIDED|95.0|0.35|2.06||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.06|0.35|0.7103
74045824|NCT04315298|147643856|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.1512|TWO_SIDED|95.0|0.89|2.43||P-value from stratified log-rank test|Log Rank|||||2.43|0.89|0.1512
74045825|NCT04315298|147643856|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.2952|TWO_SIDED|95.0|0.85|2.24||P-value from stratified log-rank test|Log Rank|||||2.24|0.85|0.2952
74045826|NCT04315298|147643857|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2297|TWO_SIDED|95.0|0.89|1.5||P-value from stratified log-rank test|Log Rank|||||1.50|0.89|0.2297
74045827|NCT04315298|147643857|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8651|TWO_SIDED|95.0|0.79|1.3||P-value from stratified log-rank test|Log Rank|||||1.30|0.79|0.8651
74045828|NCT04315298|147643858|SUPERIORITY||Risk Difference (RD)|-1.0||||0.8864|TWO_SIDED|95.0|-15.2|12.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||12.1|-15.2|0.8864
74045829|NCT04315298|147643858|SUPERIORITY||Risk Difference (RD)|-2.1||||0.75|TWO_SIDED|95.0|-15.8|10.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.1|-15.8|0.7500
74045830|NCT04315298|147643859|SUPERIORITY||Risk Difference (RD)|-1.5||||0.6858|TWO_SIDED|95.0|-9.1|5.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||5.6|-9.1|0.6858
74045831|NCT04315298|147643859|SUPERIORITY||Risk Difference (RD)|0.4||||0.9173|TWO_SIDED|95.0|-7.0|7.0||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||7.0|-7.0|0.9173
74045832|NCT04315298|147643860|SUPERIORITY||Risk Difference (RD)|4.5||||0.5239|TWO_SIDED|95.0|-9.7|17.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||17.3|-9.7|0.5239
74045833|NCT04315298|147643860|SUPERIORITY||Risk Difference (RD)|3.7||||0.5809|TWO_SIDED|95.0|-10.0|15.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||15.6|-10.0|0.5809
74045834|NCT04315298|147643861|SUPERIORITY||Risk Difference (RD)|0.4||||0.9343|TWO_SIDED|95.0|-9.3|10.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.1|-9.3|0.9343
74045835|NCT04315298|147643861|SUPERIORITY||Risk Difference (RD)|-5.0||||0.2822|TWO_SIDED|95.0|-14.1|4.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.1|-14.1|0.2822
74045836|NCT04315298|147643862|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.4519|TWO_SIDED|95.0|0.75|2.18||P-value from stratified log-rank test|Log Rank|||||2.18|0.75|0.4519
74045837|NCT04315298|147643862|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.2818|TWO_SIDED|95.0|0.81|2.24||P-value from stratified log-rank test|Log Rank|||||2.24|0.81|0.2818
74045838|NCT04315298|147643863|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.4674|TWO_SIDED|95.0|0.84|1.43||P-value from stratified log-rank test|Log Rank|||||1.43|0.84|0.4674
74045839|NCT04315298|147643863|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.8503|TWO_SIDED|95.0|0.77|1.28||P-value from stratified log-rank test.|Log Rank|||||1.28|0.77|0.8503
74016878|NCT03823391|147585328|SUPERIORITY||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|3.207||0.601|TWO_SIDED|90.0|-7.08|3.7|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||3.70|-7.08|0.601
74016879|NCT03823391|147585329|SUPERIORITY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|3.205||0.737|TWO_SIDED|90.0|-6.47|4.3|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||4.30|-6.47|0.737
74016880|NCT03823391|147585330|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.418||0.612|TWO_SIDED|90.0|-0.92|0.49|||Mixed Effect Model Repeated Measurement|Analysis included treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||0.49|-0.92|0.612
74016881|NCT03823391|147585331|SUPERIORITY||Response Rate Difference|-4.0||||0.877|TWO_SIDED|90.0|-28.5|20.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factors.|Response rate difference = ABBV-3373 - Adalimumab|||20.5|-28.5|0.877
74016882|NCT03823391|147585332|SUPERIORITY||Response Rate Difference|-13.1||||0.426|TWO_SIDED|90.0|-37.2|11.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors.|Response rate difference = ABBV-3373 - Adalimumab|||11.0|-37.2|0.426
74016883|NCT04175626|147585359|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint was evaluated by performing an exact, binomial test comparing the rate of TLF for the Orsiro stent at 1 year to a performance goal of 6.9%, with Type I error (alpha) of 0.025 and power of 80%. The null hypothesis (Ho) was stated as: The TLF rate of the Orsiro stent at 1 year is greater than or equal to 6.9%. The alternative hypothesis (Ha) was stated as: The TLF rate of the Orsiro stent at 1 year is less than 6.9%.||||<0.0001
74045840|NCT04315298|147643864|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.6156|TWO_SIDED|95.0|0.31|2.02||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.02|0.31|0.6156
73880495|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2621|TWO_SIDED|95.0|0.65|4.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.74|0.65|0.2621
73880496|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0092|TWO_SIDED|95.0|1.37|9.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.21|1.37|0.0092
74016884|NCT01562548|147585374|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-0.21||||0.68|TWO_SIDED|95.0|-1.23|0.8||P-value was associated with t-test for difference of LS means|t-test, 2 sided|The model included factors for treatment (as a fixed effect) and site (as a random effect).|Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||0.80|-1.23|0.68
74045841|NCT04315298|147643865|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0843|TWO_SIDED|95.0|0.41|1.03||P-value from stratified log-rank test|Log Rank|||||1.03|0.41|0.0843
74045842|NCT04315298|147643865|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.1576|TWO_SIDED|95.0|0.44|1.07||P-value from stratified log-rank test|Log Rank|||||1.07|0.44|0.1576
74095880|NCT00593736|147741426|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.082
74095881|NCT00593736|147741426|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.549
74095882|NCT00593736|147741427|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.860
74045843|NCT04315298|147643866|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.198|TWO_SIDED|95.0|0.57|1.14||P-value from stratified log-rank test|Log Rank|||||1.14|0.57|0.1980
74045844|NCT04315298|147643866|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7973|TWO_SIDED|95.0|0.73|1.36||P-value from stratified log-rank test.|Log Rank|||||1.36|0.73|0.7973
74045845|NCT04315298|147643867|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.5023|TWO_SIDED|95.0|0.13|2.75||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.75|0.13|0.5023
74045846|NCT04315298|147643868|SUPERIORITY||Risk Difference (RD)|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2804|TWO_SIDED|95.0|-0.2|0.8||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.8|-0.2|0.2804
74095883|NCT00593736|147741427|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.997
74045847|NCT04315298|147643868|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5023|TWO_SIDED|95.0|-0.5|0.3||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.3|-0.5|0.5023
74095884|NCT00593736|147741427|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.834
73880497|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|5.69||||0.0007|TWO_SIDED|95.0|2.09|15.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.48|2.09|0.0007
73880498|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|8.85|||<|0.0001|TWO_SIDED|95.0|3.08|25.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||25.43|3.08|<0.0001
74045848|NCT04315298|147643868|SUPERIORITY||Risk Difference (RD)|0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3821|TWO_SIDED|95.0|-0.7|1.9||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.9|-0.7|0.3821
74045849|NCT04315298|147643868|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.59||0.9737|TWO_SIDED|95.0|-1.2|1.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.1|-1.2|0.9737
74045850|NCT04315298|147643868|SUPERIORITY||Risk Difference (RD)|1.2|STANDARD_ERROR_OF_MEAN|1.15||0.3179|TWO_SIDED|95.0|-1.1|3.4||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||3.4|-1.1|0.3179
74045851|NCT04315298|147643868|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|1.03||0.6302|TWO_SIDED|95.0|-1.5|2.5||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||2.5|-1.5|0.6302
74095885|NCT00593736|147741428|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.837
74095886|NCT00593736|147741428|SUPERIORITY_OR_OTHER|||||||0.321||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.321
74095887|NCT00593736|147741428|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.978
74095888|NCT00593736|147741429|SUPERIORITY_OR_OTHER|||||||0.513||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.513
73880499|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4259|TWO_SIDED|95.0|0.55|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.08|0.55|0.4259
73880500|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1334|TWO_SIDED|95.0|0.79|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.74|0.79|0.1334
74016885|NCT01562548|147585374|SUPERIORITY_OR_OTHER||Least Squares Means Difference|0.35||||0.52|TWO_SIDED|95.0|-0.72|1.42||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||1.42|-0.72|0.52
74045852|NCT04315298|147643868|SUPERIORITY||Risk Difference (RD)|1.8|STANDARD_ERROR_OF_MEAN|1.64||0.2862|TWO_SIDED|95.0|-1.5|5.0||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||5.0|-1.5|0.2862
74045853|NCT04315298|147643868|SUPERIORITY||Risk Difference (RD)|1.1|STANDARD_ERROR_OF_MEAN|1.49||0.4509|TWO_SIDED|95.0|-1.8|4.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||4.1|-1.8|0.4509
73880501|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.39||||0.012|TWO_SIDED|95.0|1.31|8.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.77|1.31|0.0120
74016886|NCT01562548|147585374|SUPERIORITY_OR_OTHER||Least Squares Means Difference|0.24||||0.58|TWO_SIDED|95.0|-0.64|1.13||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was Second named treatment - first named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||1.13|-0.64|0.58
74016887|NCT01496066|147585388|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
74016888|NCT01496066|147585389|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
74016889|NCT01496066|147585390|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
74016890|NCT01496066|147585391|SUPERIORITY|||||||0.0318|||||||t-test, 2 sided|||||||.0318
74016891|NCT01496066|147585392|EQUIVALENCE|a two-group t-test of equivalence in means was used|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|99.0|-0.06|-0.02||||||||-0.02|-0.06|
74016892|NCT03237065|147585393|SUPERIORITY||Risk Difference (RD)|-65.8|||<|0.0001|TWO_SIDED|95.0|-76.6|-49.8|||Cochran-Mantel-Haenszel|Rate difference with 95% Newcombe confidence intervals (CI) adjusted for stratum, using the Cochran-Mantel-Haenszel method.|Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."||-49.8|-76.6|<0.0001
74016893|NCT03237065|147585394|SUPERIORITY|||||||0.0511|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan- Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) \<2 mg/dL were included.||||0.0511
74016894|NCT03237065|147585395|SUPERIORITY||Risk Difference (RD)|-44.6|||<|0.0001|TWO_SIDED|95.0|-57.7|-31.6|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (\< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.||-31.6|-57.7|<0.0001
74016895|NCT03237065|147585396|SUPERIORITY||Mean Difference (Final Values)|0.46|||<|0.0001|TWO_SIDED|95.0|0.3|0.62|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.62|0.30|<0.0001
74045854|NCT04315298|147643869|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.33||0.564|TWO_SIDED|95.0|-0.8|0.5||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.5|-0.8|0.5640
74045855|NCT04315298|147643869|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.1602|TWO_SIDED|95.0|-1.0|0.2||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.2|-1.0|0.1602
74045856|NCT04315298|147643869|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.64||0.9144|TWO_SIDED|95.0|-1.3|1.2||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.2|-1.3|0.9144
74045857|NCT04315298|147643869|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|0.61||0.145|TWO_SIDED|95.0|-2.1|0.3||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||0.3|-2.1|0.1450
74016896|NCT03237065|147585396|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.0001|TWO_SIDED|95.0|0.32|0.76|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.76|0.32|<0.0001
74016897|NCT03237065|147585396|SUPERIORITY||Mean Difference (Final Values)|0.73|||<|0.0001|TWO_SIDED|95.0|0.49|0.96|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.96|0.49|<0.0001
74016898|NCT03237065|147585396|SUPERIORITY||Mean Difference (Final Values)|1.22|||<|0.0001|TWO_SIDED|95.0|0.99|1.46|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.46|0.99|<0.0001
74045858|NCT04315298|147643869|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.95||0.8378|TWO_SIDED|95.0|-1.7|2.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||2.1|-1.7|0.8378
74045859|NCT04315298|147643869|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|0.89||0.1988|TWO_SIDED|95.0|-2.9|0.6||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||0.6|-2.9|0.1988
74045860|NCT04315298|147643869|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|1.26||0.8556|TWO_SIDED|95.0|-2.2|2.7||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||2.7|-2.2|0.8556
74045861|NCT04315298|147643869|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|1.19||0.263|TWO_SIDED|95.0|-3.7|1.0||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||1.0|-3.7|0.2630
74045862|NCT04315298|147643870|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3662|TWO_SIDED|95.0|-0.2|0.5||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.5|-0.2|0.3662
73880502|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.84||||0.2443|TWO_SIDED|95.0|0.66|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.10|0.66|0.2443
74045863|NCT04315298|147643870|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.16||0.082|TWO_SIDED|95.0|0.0|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.6|0.0|0.0820
74045864|NCT04315298|147643870|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.37||0.6984|TWO_SIDED|95.0|-0.9|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.9|0.6984
74045865|NCT04315298|147643870|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.32||0.9833|TWO_SIDED|95.0|-0.6|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.6|0.9833
74045866|NCT04315298|147643870|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.56||0.1436|TWO_SIDED|95.0|-0.3|2.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||2.0|-0.3|0.1436
74045867|NCT04315298|147643870|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.49||0.419|TWO_SIDED|95.0|-0.6|1.4||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.4|-0.6|0.4190
74045868|NCT04315298|147643870|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.652|TWO_SIDED|95.0|-0.7|1.2||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||1.2|-0.7|0.6520
74045869|NCT04315298|147643870|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.801|TWO_SIDED|95.0|-1.1|0.9||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.9|-1.1|0.8010
74045870|NCT04315298|147643871|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3724|TWO_SIDED|95.0|-0.4|0.2||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.2|-0.4|0.3724
74045871|NCT04315298|147643871|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.7034|TWO_SIDED|95.0|-0.2|0.3||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.3|-0.2|0.7034
74045872|NCT04315298|147643871|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5841|TWO_SIDED|95.0|-0.4|0.7||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.7|-0.4|0.5841
74045873|NCT04315298|147643871|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.6648|TWO_SIDED|95.0|-0.4|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.4|0.6648
74045874|NCT04315298|147643871|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.36||0.4624|TWO_SIDED|95.0|-0.4|1.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.0|-0.4|0.4624
74045875|NCT04315298|147643871|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2546|TWO_SIDED|95.0|-0.3|1.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.0|-0.3|0.2546
74045876|NCT04315298|147643871|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.38||0.5312|TWO_SIDED|95.0|-1.0|0.5||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.5|-1.0|0.5312
74045877|NCT04315298|147643871|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.3039|TWO_SIDED|95.0|-1.1|0.3||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.3|-1.1|0.3039
74045878|NCT01183104|147643897|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was 0.3%.|LS mean difference|0.11||||0.087|TWO_SIDED|95.0|-0.02|0.24|||ANCOVA|||||0.24|-0.02|0.087
74045879|NCT01183104|147643898|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|||||||0.002
74045880|NCT01183104|147643899|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
74095889|NCT00593736|147741429|SUPERIORITY_OR_OTHER|||||||0.751||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.751
74095890|NCT00593736|147741429|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.242
74095891|NCT00593736|147741430|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.307
74095892|NCT00593736|147741430|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.765
74095893|NCT00593736|147741430|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.727
74095894|NCT00593736|147741431|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.902
74095895|NCT00593736|147741431|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.590
74095896|NCT00593736|147741431|SUPERIORITY_OR_OTHER|||||||0.29||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.290
74045881|NCT01183104|147643900|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||||||0.030
74045882|NCT01183104|147643901|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
74045883|NCT01183104|147643902|SUPERIORITY_OR_OTHER|||||||0.043|||||||ANCOVA|||||||0.043
74045884|NCT03267511|147643903|OTHER||Difference of Least Mean Square|0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6499|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|||"The reason for entering same analysis for primary and secondary is because statistical analysis was not done separately for primary outcome measure.~The decision was clinical decision at the time of protocol design.There was no comparisons for the primary objective as the main objective was to look at the rank order of the treatments in level of stain reduction after 8 weeks of treatment. This was achieved via the adjusted means and confidence intervals for the means along with plots of MLSI over time. The hypothesis was that the test products would reduce stain to a greater extent than the reference products. Two comparisons of interest were done under secondary and exploratory objectives."|0.31|-0.19|0.6499
74045885|NCT03267511|147643903|OTHER||Difference of Least Square mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128||0.568|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|-0.33 to 0.18|||0.18|-0.33|0.5680
74045886|NCT03267511|147643904|OTHER||Difference of Least Square mean|0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6499|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.31|-0.19|0.6499
74045887|NCT03267511|147643905|OTHER||Difference of Least Square mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128||0.568|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.18|-0.33|0.5680
74045888|NCT01594749|147643906|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on Cochran-Mantel-Haenszel (CMH) method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
74045889|NCT01594749|147643907|SUPERIORITY_OR_OTHER||Difference in percentage vs. Control|0.6||||0.085|TWO_SIDED|95.0|-0.2|1.7||P-value based on Miettinen \& Nurminen method|Miettinen & Nurminen method|||||1.7|-0.2|0.085
74045890|NCT01594749|147643909|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
74045891|NCT01594749|147643910|SUPERIORITY_OR_OTHER|||||||0.184||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||0.184
74045892|NCT01594749|147643911|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
74045893|NCT00922974|147643920|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Based on the one-sided exact binomial test with α=0.025 and a 2:1 randomization, 228 patients would be required to detect a 40% improvement in the response rate from 51% (external beam radiation therapy) to 70% (Radiosurgery/SBRT) with a statistical power of 0.80.||||0.99
74045894|NCT00922974|147643921|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.38|TWO_SIDED|95.0|0.72|1.27|||Stratified log rank|One-sided significance level = 0.025.|Reference level = Radiosurgery/SBRT|||1.27|0.72|0.38
74016899|NCT03237065|147585396|SUPERIORITY||Mean Difference (Final Values)|1.24|||<|0.0001|TWO_SIDED|95.0|0.98|1.51|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.51|0.98|<0.0001
74016900|NCT03237065|147585396|SUPERIORITY||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.91|1.43|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.43|0.91|<0.0001
74016901|NCT03237065|147585397|SUPERIORITY||Mean Difference (Final Values)|13.99|||<|0.0001|TWO_SIDED|95.0|9.38|18.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||18.59|9.38|<0.0001
74016902|NCT03237065|147585397|SUPERIORITY||Mean Difference (Final Values)|15.84|||<|0.0001|TWO_SIDED|95.0|9.45|22.23|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.23|9.45|<0.0001
74016903|NCT03237065|147585397|SUPERIORITY||Mean Difference (Final Values)|21.66|||<|0.0001|TWO_SIDED|95.0|14.72|28.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||28.59|14.72|<0.0001
74016904|NCT03237065|147585397|SUPERIORITY||Mean Difference (Final Values)|36.17|||<|0.0001|TWO_SIDED|95.0|29.28|43.06|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||43.06|29.28|<0.0001
74016905|NCT03237065|147585397|SUPERIORITY||Mean Difference (Final Values)|37.86|||<|0.0001|TWO_SIDED|95.0|29.99|45.72|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||45.72|29.99|<0.0001
74016906|NCT03237065|147585397|SUPERIORITY||Mean Difference (Final Values)|34.53|||<|0.0001|TWO_SIDED|95.0|26.8|42.26|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||42.26|26.80|<0.0001
74016907|NCT03237065|147585399|SUPERIORITY||Mean Difference (Final Values)|-96.8|||<|0.0001|TWO_SIDED|95.0|-119.8|-73.8|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-73.8|-119.8|<0.0001
74045895|NCT00922974|147643922|SUPERIORITY||Hazard Ratio (HR)|1.73||||0.29|TWO_SIDED|95.0|0.24|12.8|||Stratified log rank|One-sided significance level = 0.025|Significance level = Radiosurgery/SBRT|||12.8|0.24|0.29
74045896|NCT00922974|147643923|SUPERIORITY|||||||0.93||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with treatment-related adverse events.||||0.93
74045897|NCT00922974|147643923|SUPERIORITY|||||||0.09||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with any adverse events.||||0.09
74045898|NCT00922974|147643924|SUPERIORITY|||||||0.59||||||Two-sided significance level = 0.05|Gray's test|||||||0.59
74045899|NCT00922974|147643925|SUPERIORITY|||||||0.38||||||Two-sided significance level = 0.05|Gray's test|||||||0.38
74045900|NCT00922974|147643926|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Assuming that the data are normally distributed, the two sample t-test assuming equal variances will be used to test the hypothesis at the one-sided 0.025 significance level. A mean difference of 7 points represents a clinically meaningful change (CMC). A difference of less than 7 points between the treatment arms will not be considered meaningful, even if it has statistical significance.||||0.28
73888061|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6||||0.5965|TWO_SIDED|95.0|-12.6|21.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.8|-12.6|0.5965
74095897|NCT00593736|147741432|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.685
74095898|NCT00593736|147741432|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.214
74045901|NCT00922974|147643927|SUPERIORITY|||||||0.4313|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.4313
74045902|NCT00922974|147643927|SUPERIORITY|||||||0.8707|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.8707
74045903|NCT00922974|147643927|SUPERIORITY|||||||0.1549|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.1549
74045904|NCT00922974|147643927|SUPERIORITY|||||||0.0193|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.0193
74045905|NCT00922974|147643927|SUPERIORITY|||||||0.0016|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||0.0016
74045906|NCT00922974|147643927|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||0.0003
74045907|NCT00922974|147643927|SUPERIORITY|||||||0.6371|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.6371
74045908|NCT00922974|147643928|SUPERIORITY|||||||0.0218|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.0218
74045909|NCT00922974|147643928|SUPERIORITY|||||||0.9437|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.9437
74045910|NCT00922974|147643928|SUPERIORITY|||||||0.0696|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.0696
74045911|NCT00922974|147643928|SUPERIORITY|||||||0.114|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.1140
74095899|NCT00593736|147741432|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.055
74095900|NCT00593736|147741433|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.589
74095901|NCT00593736|147741433|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.156
74095902|NCT00593736|147741433|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.041
74095903|NCT03493386|147741435|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||AUC (0-t)|||1.07|0.97|
74095904|NCT03493386|147741435|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||AUC(0-inf)|||1.07|0.97|
74095905|NCT03493386|147741436|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.04|||||TWO_SIDED|90.0|0.97|1.12|||||Cmax|||1.12|0.97|
74095906|NCT03493386|147741443|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||TWO_SIDED|90.0|0.82|1.01|||||AUC (0-t)|||1.01|0.82|
74095907|NCT03493386|147741443|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||TWO_SIDED|90.0|0.82|1.01|||||AUC (0-inf)|||1.01|0.82|
74095908|NCT03493386|147741444|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geomtric mean|0.89||||||90.0|0.73|1.08||||||||1.08|0.73|
74095909|NCT00271154|147741531|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: mean 12-month change in LVESVi in group 1 = mean 12-month change in LVESVi in group 2.||||<0.0001
74095910|NCT00271154|147741532|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Chi-squared|||Null hypothesis: Percentage worsened in CRT OFF group = Percentage worsened in CRT ON group||||0.10
74095911|NCT01059344|147741550|SUPERIORITY_OR_OTHER|||||||0.069|||||||Chi-squared|||||||0.069
74095912|NCT01059344|147741551|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74095913|NCT01059344|147741552|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74095914|NCT01059344|147741553|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
74095915|NCT01059344|147741554|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74095916|NCT01059344|147741555|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74095917|NCT01059344|147741556|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
74095918|NCT01739348|147741557|SUPERIORITY||Difference in Least Squares Mean|0.2||||0.6287|TWO_SIDED|97.51|-0.9|1.3|||Longitudinal ANCOVA|||||1.3|-0.9|0.6287
74095919|NCT01739348|147741557|SUPERIORITY||Difference in Least Squares Mean|0.4||||0.4625|TWO_SIDED|97.51|-0.8|1.5|||Longitudinal ANCOVA|||||1.5|-0.8|0.4625
74095920|NCT01739348|147741558|SUPERIORITY||Difference in Least Squares Means|0.5||||0.4925|TWO_SIDED|97.51|-1.1|2.1|||Longitudinal ANCOVA|||||2.1|-1.1|0.4925
74095921|NCT01739348|147741558|SUPERIORITY||Difference in Least Squares Means|0.7||||0.3221|TWO_SIDED|97.51|-0.9|2.3|||Longitudinal ANCOVA|||||2.3|-0.9|0.3221
74095922|NCT01739348|147741565|SUPERIORITY||Difference in Least Squares Means|0.0||||0.8426|TWO_SIDED|97.51|-0.4|0.3|||Longitudinal ANCOVA|||||0.3|-0.4|0.8426
74095923|NCT01739348|147741565|SUPERIORITY||Difference in Least Squares Means|0.0||||0.8264|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA|||||0.4|-0.3|0.8264
74095924|NCT01739348|147741566|SUPERIORITY||Difference in Least Squares Means|-0.6||||0.0005|TWO_SIDED|97.51|-1.0|-0.2|||Longitudinal ANCOVA|||||-0.2|-1.0|0.0005
74095925|NCT01739348|147741566|SUPERIORITY||Difference in Least Squares Means|-0.7||||0.0002|TWO_SIDED|97.51|-1.1|-0.3|||Longitudinal ANCOVA|||||-0.3|-1.1|0.0002
74095926|NCT01739348|147741567|SUPERIORITY||Ratio of Fold Change from Baseline|0.95||||0.2138|TWO_SIDED|95.0|0.87|1.04|||Longitudinal ANCOVA|||||1.04|0.87|0.2138
74095927|NCT01739348|147741567|SUPERIORITY||Ratio of Fold Change from Baseline|0.97||||0.433|TWO_SIDED|95.0|0.9|1.05|||Longitudinal ANCOVA|||||1.05|0.90|0.4330
74095928|NCT01739348|147741568|SUPERIORITY||Difference in Least Squares Means|-0.03||||0.0066|TWO_SIDED|95.0|-0.05|0.0|||Longitudinal ANCOVA|||||0.00|-0.05|0.0066
74095929|NCT01739348|147741568|SUPERIORITY||Difference in Least Squares Means|-0.04|||<|0.0001|TWO_SIDED|95.0|-0.06|-0.02|||Longitudinal ANCOVA|||||-0.02|-0.06|<0.0001
74095930|NCT01739348|147741570|SUPERIORITY||Difference in Least Squares Means|0.7||||0.2949|TWO_SIDED|95.0|-0.6|2.1|||Longitudinal ANCOVA|||||2.1|-0.6|0.2949
74095931|NCT01739348|147741570|SUPERIORITY||Difference in Least Squares Means|1.1||||0.1372|TWO_SIDED|95.0|-0.4|2.6|||Longitudinal ANCOVA|||||2.6|-0.4|0.1372
74095932|NCT01739348|147741571|SUPERIORITY||Difference in Least Squares Means|0.2||||0.4721|TWO_SIDED|95.0|-0.3|0.7|||Longitudinal ANCOVA|||||0.7|-0.3|0.4721
73888062|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.3175|TWO_SIDED|95.0|-8.5|25.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.9|-8.5|0.3175
74095933|NCT01739348|147741571|SUPERIORITY||Difference in Least Squares Means|0.5||||0.0599|TWO_SIDED|95.0|0.0|1.0|||Longitudinal ANCOVA|||||1.0|0.0|0.0599
74095934|NCT01447420|147741575|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Chi-squared|Participants without measurement at the end of the 24 week untreated follow-up period were considered as non-responders.||IL28B Genotypes (CC, CT or TT)||||0.0007
74095935|NCT01447420|147741578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.69|4.14|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia after the first month of treatment vs No anemia||4.14|0.69|
74095936|NCT01447420|147741578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.28|2.59|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia in the first month of treatment vs No anemia||2.59|0.28|
74095937|NCT01447420|147741578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.45|||||TWO_SIDED|95.0|2.27|13.12|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs CT||13.12|2.27|
74095938|NCT01447420|147741578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||||TWO_SIDED|95.0|1.19|13.61|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs TT||13.61|1.19|
74045912|NCT00922974|147643928|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||0.0003
74045913|NCT00922974|147643928|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||<0.0001
74095939|NCT04420273|147741582|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||1-month survey||||<0.001
74095940|NCT04420273|147741582|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||2- months||||<0.001
74095941|NCT04420273|147741582|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||3-months||||<0.001
74095942|NCT04420273|147741583|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
74095943|NCT04420273|147741584|OTHER||||||<|0.1|||||||Chi-squared|||||||< 0.1
74095944|NCT04420273|147741585|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
74095945|NCT04420273|147741586|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
74095946|NCT04420273|147741587|OTHER|||||||0.459|||||||Chi-squared|||||||0.459
74095947|NCT04420273|147741587|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74095948|NCT04420273|147741588|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
74095949|NCT01974440|147741593|SUPERIORITY||Hazard Ratio (HR)|0.806||||0.0922|TWO_SIDED|95.0|0.626|1.037|||Log Rank|||||1.037|0.626|0.0922
74095950|NCT01974440|147741594|SUPERIORITY||Hazard Ratio (HR)|0.725||||0.4505|TWO_SIDED|95.0|0.312|1.682|||Log Rank|||||1.682|0.312|0.4505
74095951|NCT04795908|147741616|NON_INFERIORITY|looking for statistical significant differences between groups||||||0.1997|||||||ANOVA|||||||0.1997
74095952|NCT04795908|147741617|NON_INFERIORITY|looking for statistical significant differences between groups||||||0.076|||||||ANOVA|||||||0.076
74095953|NCT04795908|147741618|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.6228|||||||ANOVA|||||||0.6228
74095954|NCT04795908|147741619|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.8984|||||||ANOVA|||||||0.8984
74095955|NCT04795908|147741620|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.8188|||||||ANOVA|||||||0.8188
74095956|NCT04795908|147741621|NON_INFERIORITY|Looking for statistically significant differences between groups||||||0.0288|||||||ANOVA|||||||0.0288
74095957|NCT04795908|147741622|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.0524|||||||ANOVA|||||||0.0524
74095958|NCT01948986|147741632|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|103.07|||||TWO_SIDED|90.0|80.32|132.27|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||132.27|80.32|
74095959|NCT01948986|147741632|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|156.34|||||TWO_SIDED|90.0|127.83|191.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||191.23|127.83|
73880503|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0022|TWO_SIDED|95.0|1.73|12.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.25|1.73|0.0022
74045914|NCT00922974|147643928|SUPERIORITY|||||||0.7732|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.7732
74045915|NCT00922974|147643929|SUPERIORITY|||||||0.5198|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.5198
74045916|NCT00922974|147643929|SUPERIORITY|||||||0.1197|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.1197
74045917|NCT00922974|147643929|SUPERIORITY|||||||0.0306|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.0306
74045918|NCT00922974|147643929|SUPERIORITY|||||||0.7903|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.7903
74045919|NCT00922974|147643929|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||<0.0001
74045920|NCT00922974|147643929|SUPERIORITY|||||||0.0026|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||0.0026
74045921|NCT00922974|147643929|SUPERIORITY|||||||0.3282|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.3282
74045922|NCT02177786|147643930|SUPERIORITY||Least Square Means Difference|0.38|STANDARD_ERROR_OF_MEAN|1.21||0.755|TWO_SIDED|95.0|-2.0|2.75||Data was calculated using a mixed-effect model repeated measures (MMRM) model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||2.75|-2.00|0.755
74045923|NCT02177786|147643930|SUPERIORITY||Least Square Means Difference|0.84|STANDARD_ERROR_OF_MEAN|1.22||0.492|TWO_SIDED|95.0|-1.55|3.23||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||3.23|-1.55|0.492
74045924|NCT02177786|147643930|SUPERIORITY||Least Square Means Difference|-0.87|STANDARD_ERROR_OF_MEAN|1.23||0.481|TWO_SIDED|95.0|-3.29|1.56||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||1.56|-3.29|0.481
74095960|NCT01948986|147741632|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|170.04|||||TWO_SIDED|90.0|139.02|207.98|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||207.98|139.02|
74045925|NCT02177786|147643931|SUPERIORITY||Difference in Percentages|-2.2||||0.798|TWO_SIDED|95.0|-16.1|11.7|||Cochran-Mantel-Haenszel|P-value was based on a Cochran-Mantel-Haenszel (CMH) test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% confidence interval (CI) in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||11.7|-16.1|0.798
74045926|NCT02177786|147643931|SUPERIORITY||Difference in Percentages|-9.2||||0.175|TWO_SIDED|95.0|-22.3|4.0|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||4.0|-22.3|0.175
74045927|NCT02177786|147643931|SUPERIORITY||Difference in Percentages|-2.9||||0.686|TWO_SIDED|95.0|-16.6|10.9|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||10.9|-16.6|0.686
74095961|NCT01948986|147741632|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|155.26|||||TWO_SIDED|90.0|124.38|193.8|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||193.80|124.38|
74016908|NCT03237065|147585399|SUPERIORITY||Mean Difference (Final Values)|-15.7||||0.1064|TWO_SIDED|95.0|-34.9|3.4|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.4|-34.9|0.1064
74016909|NCT03237065|147585399|SUPERIORITY||Mean Difference (Final Values)|-251.7|||<|0.0001|TWO_SIDED|95.0|-307.2|-196.2|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-196.2|-307.2|<0.0001
74095962|NCT01948986|147741633|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|103.42|||||TWO_SIDED|90.0|80.66|132.61|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||132.61|80.66|
74095963|NCT01948986|147741633|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|151.63|||||TWO_SIDED|90.0|124.05|185.34|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||185.34|124.05|
74095964|NCT01948986|147741633|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|168.11|||||TWO_SIDED|90.0|137.53|205.49|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||205.49|137.53|
74095965|NCT01948986|147741633|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|151.8|||||TWO_SIDED|90.0|121.69|189.36|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||189.36|121.69|
74095966|NCT01948986|147741635|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|101.57|||||TWO_SIDED|90.0|78.83|130.87|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||130.87|78.83|
74095967|NCT01948986|147741635|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|143.74|||||TWO_SIDED|90.0|117.15|176.37|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||176.37|117.15|
74095968|NCT01948986|147741635|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|140.37|||||TWO_SIDED|90.0|114.4|172.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||172.23|114.40|
74095969|NCT01948986|147741635|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|90.18|||||TWO_SIDED|90.0|71.99|112.96|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||112.96|71.99|
74095970|NCT01948986|147741642|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|80.39|||||TWO_SIDED|90.0|59.41|108.76|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||108.76|59.41|
74095971|NCT01948986|147741642|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|53.46|||||TWO_SIDED|90.0|41.64|68.63|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||68.63|41.64|
73880504|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|6.6||||0.0004|TWO_SIDED|95.0|2.35|18.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||18.58|2.35|0.0004
74095972|NCT01948986|147741642|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|43.45|||||TWO_SIDED|90.0|33.85|55.78|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||55.78|33.85|
74095973|NCT01948986|147741642|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|29.02|||||TWO_SIDED|90.0|22.04|38.21|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||38.21|22.04|
74095974|NCT01948986|147741659|SUPERIORITY_OR_OTHER||Ratio: Mild Ren. Impa./T2DM Norm. Renal|76.73|||||TWO_SIDED|95.0|48.58|121.19|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||121.19|48.58|
74095975|NCT01948986|147741659|SUPERIORITY_OR_OTHER||Ratio: Mod. Ren. Impa./T2DM Norm. Renal|86.52|||||TWO_SIDED|95.0|54.78|136.65|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||136.65|54.78|
74095976|NCT01948986|147741659|SUPERIORITY_OR_OTHER||Ratio: Sev. Ren. Impa./T2DM Norm. Renal|72.74|||||TWO_SIDED|95.0|44.63|118.58|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||118.58|44.63|
74095977|NCT01948986|147741661|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./T2DM Norm. Ren|49.75|||||TWO_SIDED|90.0|27.22|90.93|||||The model was an ANOVA model with renal function group as a fixed effect.|||90.93|27.22|
74095978|NCT01948986|147741661|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./T2DM Norm. Ren|38.1|||||TWO_SIDED|90.0|20.85|69.64|||||The model was an ANOVA model with renal function group as a fixed effect.|||69.64|20.85|
74095979|NCT01948986|147741661|SUPERIORITY_OR_OTHER||Ratio (Sev. Renal Impair./T2DM Norm. Ren|13.95|||||TWO_SIDED|90.0|7.32|26.58|||||The model was an ANOVA model with renal function group as a fixed effect.|||26.58|7.32|
74095980|NCT00536263|147741662|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.008||||0.86|TWO_SIDED|95.0|-0.063|0.079||P-values are unadjusted; Hochberg's adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."||0.079|-0.063|0.860
74016910|NCT03237065|147585399|SUPERIORITY||Mean Difference (Final Values)|-79.1|||<|0.0001|TWO_SIDED|95.0|-103.7|-54.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-54.5|-103.7|<0.0001
73880505|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|12.17|||<|0.0001|TWO_SIDED|95.0|4.05|36.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||36.63|4.05|<0.0001
74016911|NCT03237065|147585399|SUPERIORITY||Mean Difference (Final Values)|-61.8|||<|0.0001|TWO_SIDED|95.0|-83.0|-40.5|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-40.5|-83.0|<0.0001
74016912|NCT03237065|147585399|SUPERIORITY||Mean Difference (Final Values)|-18.0||||0.0039|TWO_SIDED|95.0|-30.1|-5.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-5.9|-30.1|0.0039
74016913|NCT03237065|147585400|SUPERIORITY||Mean Difference (Final Values)|-57.5||||0.1243|TWO_SIDED|95.0|-131.1|16.1|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||16.1|-131.1|0.1243
74045928|NCT03950440|147643932|OTHER|Propensity scores were obtained from three separate multivariable logistic regression models contrasting each group versus the two other groups. The result from this multivariable model quantifies the degree of separation between both groups.|Risk Ratio (RR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.16|0.44||The double robust approach refers to the weighted analysis with all variables involved in the construction of the propensity-based weights added as confounders in the model.|Poisson regression||TAVI-group compared to the SAVR-group|Frailty scores (Tilburg and essential) and Euroscore were specified in the protocol. Age was added during the meeting before start of the data-analysis|The double robust approach refers to the weighted analysis with all variables involved in the construction of the propensity-based weights added as confounders in the model.|0.44|0.16|<0.0001
74045929|NCT00439309|147643942|NON_INFERIORITY_OR_EQUIVALENCE|The sealing success rates for the investigational group and control groups were assumed to be 0.85 (85%) and 0.75 (75%), respectively, and the non-inferiority margin (10%) is 0.10. For safety reasons it was desired to have at least 100 Vascular Sealant treated subjects. It was determined that a sample size of at least 31 evaluable subjects is required for the control group. For blocking purposes, the number of evaluable control group subjects was set to 33, for a 3:1 randomization.||||||0.072|||||||Z-Test|one-sided Z-test based on the normal approximation to the binomial distribution testing||The effectiveness analyses were performed on the ITT population.||||0.072
74045930|NCT00439309|147643943|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAM Treatment from two-sided test based on the GEE regression model.||||||0.006
74045931|NCT00439309|147643944|SUPERIORITY_OR_OTHER|||||||0.654|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAMTreatment from two-sided test based on the GEE regression model||||||0.654
74045932|NCT00439309|147643945|SUPERIORITY_OR_OTHER|||||||0.089|||||||t-test, 2 sided|||||||0.089
74045933|NCT00439309|147643946|SUPERIORITY_OR_OTHER|||||||0.404|||||||Log Rank|Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group||||||0.404
74045934|NCT01957215|147643948|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.72||||0.0201||95.0|0.1134|1.3199||P- value was obtained from ANCOVA model with treatment and site as fixed effects and NRS Baseline value as a covariate|ANCOVA||ADJ DIFF is the Treatment difference defined as the Adjusted Mean of 0.35% Indomethacin Patches minus Adjusted Mean of Placebo Patches|||1.3199|0.1134|0.0201
74045935|NCT01951326|147644052|SUPERIORITY|||||||0.0048|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0048
74095981|NCT00536263|147741662|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.139|||<|0.001|TWO_SIDED|95.0|0.061|0.217||P-values are unadjusted; Hochberg's adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."||0.217|0.061|<0.001
73888063|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9||||0.6551|TWO_SIDED|95.0|-13.3|21.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.0|-13.3|0.6551
74045936|NCT01951326|147644053|SUPERIORITY|||||||0.0116|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0116
74045937|NCT01951326|147644054|SUPERIORITY|||||||0.0616|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0616
74045938|NCT01951326|147644055|SUPERIORITY|||||||0.0851|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0851
74045939|NCT01951326|147644056|SUPERIORITY|||||||0.0147|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0147
73880506|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.7||||0.3101|TWO_SIDED|95.0|0.61|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.71|0.61|0.3101
73880507|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0116|TWO_SIDED|95.0|1.34|10.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.00|1.34|0.0116
73880508|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0045|TWO_SIDED|95.0|1.56|11.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.05|1.56|0.0045
73880509|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3505|TWO_SIDED|95.0|0.62|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.88|0.62|0.3505
73880510|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0739|TWO_SIDED|95.0|0.92|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.62|0.92|0.0739
73880511|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0163|TWO_SIDED|95.0|1.24|8.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.20|1.24|0.0163
73880512|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|8.49||||0.0001|TWO_SIDED|95.0|2.81|25.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||25.64|2.81|0.0001
73880513|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8358|TWO_SIDED|95.0|0.35|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.35|0.35|0.8358
73880514|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1006|TWO_SIDED|95.0|0.86|5.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.52|0.86|0.1006
73880515|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0484|TWO_SIDED|95.0|1.01|6.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.34|1.01|0.0484
73880516|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6492|TWO_SIDED|95.0|0.5|3.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.08|0.50|0.6492
73880517|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.74||||0.223|TWO_SIDED|95.0|0.71|4.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.27|0.71|0.2230
73880518|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.43||||0.0126|TWO_SIDED|95.0|1.3|9.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.02|1.30|0.0126
73880519|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|5.56||||0.0014|TWO_SIDED|95.0|1.94|15.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.98|1.94|0.0014
73880520|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|0.7||||0.4713|TWO_SIDED|95.0|0.27|1.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||1.83|0.27|0.4713
73880521|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1397|TWO_SIDED|95.0|0.79|5.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.12|0.79|0.1397
73880522|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.75||||0.2272|TWO_SIDED|95.0|0.71|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.34|0.71|0.2272
74045940|NCT01951326|147644057|SUPERIORITY|||||||0.151|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.1510
74045941|NCT01951326|147644058|SUPERIORITY|||||||0.2402|||||||Log Rank|||||||0.2402
74045942|NCT01951326|147644059|SUPERIORITY|||||||0.046|||||||Log Rank|||||||0.0460
74045943|NCT01951326|147644060|SUPERIORITY|||||||0.0031|||||||Log Rank|||||||0.0031
74045944|NCT01951326|147644061|SUPERIORITY|||||||0.01|||||||Log Rank|||||||0.0100
74045945|NCT01951326|147644062|SUPERIORITY|||||||0.0077|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0077
74045946|NCT01951326|147644063|SUPERIORITY|||||||0.0422|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0422
74045947|NCT00047008|147644127|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.18|TWO_SIDED|95.0|0.719|1.128|||Log Rank|||A sample size of 684 analyzable patients provides 80% power to detect a relative reduction of 25% in the rate of death in the accelerated-fractionation radiotherapy group as compared with the standard-fractionation radiotherapy group, assuming a 2-year rate of overall survival of 45% in the standard-fractionation radiotherapy group, with the use of a one-sided log-rank test at the 0.05 significance level.||1.128|0.719|0.180
74095982|NCT00536263|147741662|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of PEG 1.5 mcg/kg\*24 weeks with respect to PEG 1.5 mcg/kg\*48 weeks was to be concluded if the lower bound of the one-sided 95% confidence interval of the difference of the rates (PEG 1.5 mcg/kg\*24 weeks minus PEG 1.5 mcg/kg\*48 weeks) was greater than the noninferiority margin of -10%.|Pairwise rate difference|-0.132|||||TWO_SIDED|90.0|-0.198|-0.065||||||||-0.065|-0.198|
74016914|NCT03237065|147585400|SUPERIORITY||Mean Difference (Final Values)|20.7||||0.5547|TWO_SIDED|95.0|-49.7|91.0|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||91.0|-49.7|0.5547
74016915|NCT03237065|147585400|SUPERIORITY||Mean Difference (Final Values)|-155.7||||0.0005|TWO_SIDED|95.0|-234.7|-76.6|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-76.6|-234.7|0.0005
74016916|NCT03237065|147585400|SUPERIORITY||Mean Difference (Final Values)|-27.3||||0.3516|TWO_SIDED|95.0|-86.0|31.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||31.5|-86.0|0.3516
74016917|NCT03237065|147585400|SUPERIORITY||Mean Difference (Final Values)|-24.3||||0.1988|TWO_SIDED|95.0|-62.3|13.7|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||13.7|-62.3|0.1988
74016918|NCT03237065|147585400|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.4379|TWO_SIDED|95.0|-18.6|41.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||41.2|-18.6|0.4379
74016919|NCT03237065|147585401|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.6869|TWO_SIDED|95.0|-1.06|0.7|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.70|-1.06|0.6869
74016920|NCT03237065|147585401|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.1037|TWO_SIDED|95.0|-2.29|0.22|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.22|-2.29|0.1037
74016921|NCT03237065|147585401|SUPERIORITY||Mean Difference (Final Values)|-1.62||||0.0213|TWO_SIDED|95.0|-2.99|-0.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.25|-2.99|0.0213
74016922|NCT03237065|147585401|SUPERIORITY||Mean Difference (Final Values)|-1.91||||0.0176|TWO_SIDED|95.0|-3.47|-0.34|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.34|-3.47|0.0176
74045948|NCT00047008|147644128|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.76|TWO_SIDED|95.0|0.83|1.43||One-sided significance level = 0.05|Gray's test|||||1.43|0.83|0.76
74045949|NCT00047008|147644129|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.8|TWO_SIDED|95.0|0.85|1.44||One-sided significance level = 0.05|Gray's test|||||1.44|0.85|0.80
74045950|NCT00047008|147644130|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.42|TWO_SIDED|95.0|0.81|1.2||One-sided significance level = 0.05|Log Rank|||||1.20|0.81|0.42
74095983|NCT00536263|147741663|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.011||||0.7|TWO_SIDED|95.0|-0.074|0.052|||Cochran-Mantel-Haenszel|Stratified by genotype||||0.052|-0.074|0.700
74095984|NCT00536263|147741663|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.054||||0.125|TWO_SIDED|95.0|-0.014|0.123|||Cochran-Mantel-Haenszel|Stratified by genotype||||0.123|-0.014|0.125
74016923|NCT03237065|147585401|SUPERIORITY||Mean Difference (Final Values)|-1.37||||0.0999|TWO_SIDED|95.0|-3.01|0.27|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.27|-3.01|0.0999
74016924|NCT03237065|147585401|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.8878|TWO_SIDED|95.0|-1.77|2.04|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.04|-1.77|0.8878
74045951|NCT00047008|147644131|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5|TWO_SIDED|95.0|0.81|1.23||One-sided significance level = 0.05|Log Rank|||||1.23|0.81|0.50
74045952|NCT00047008|147644132|SUPERIORITY|||||||0.21||||||Two-side significance level = 0.05|Fisher Exact|||Acute toxicity||||0.21
74045953|NCT00047008|147644132|SUPERIORITY|||||||0.18||||||Two-sided significance level = 0.05|Fisher Exact|||Late toxicity||||0.18
74045954|NCT00047008|147644133|SUPERIORITY|||||||0.92||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.92
74045955|NCT00047008|147644134|SUPERIORITY|||||||0.67||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.67
74045956|NCT00047008|147644135|SUPERIORITY|||||||0.43||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.43
74045957|NCT00047008|147644136|SUPERIORITY|||||||0.39||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.39
74045958|NCT01366534|147644144|OTHER||Vaccine Efficacy Maentel-Haenzel Method|-17.6||||0.7675|TWO_SIDED|95.0|-107.4|33.3|||2-sided Fisher Exact test||Pre-defined futility criteria for efficacy: point estimate of increase of VE in Ad35.CS.01 Group over GSK257049 Group less than 0%|Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at one month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||33.3|-107.4|0.7675
74095985|NCT00536263|147741663|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.065|||||TWO_SIDED|90.0|-0.122|-0.008||||||||-0.008|-0.122|
74095986|NCT00536263|147741664|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.016||||0.598|TWO_SIDED|95.0|-0.078|0.047|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.047|-0.078|0.598
74095987|NCT00536263|147741664|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.041||||0.24|TWO_SIDED|95.0|-0.027|0.108|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.108|-0.027|0.24
74095988|NCT00536263|147741664|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.056|||||TWO_SIDED|90.0|-0.112|-0.001||||||End of treatment||-0.001|-0.112|
74095989|NCT00536263|147741664|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.006||||0.83|TWO_SIDED|95.0|-0.075|0.063|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.063|-0.075|0.830
74095990|NCT00536263|147741664|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.13||||0.001|TWO_SIDED|95.0|0.053|0.208|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.208|0.053|0.001
74095991|NCT00536263|147741664|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.136||||||90.0|-0.201|-0.071||||||24 weeks after EOT||-0.071|-0.201|
74095992|NCT00536263|147741665|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.072||||0.076|TWO_SIDED|95.0|-0.007|0.151|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.151|-0.007|0.076
74095993|NCT00536263|147741665|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.135||||0.001|TWO_SIDED|95.0|0.053|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.216|0.053|0.001
74095994|NCT00536263|147741665|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.063|||||TWO_SIDED|90.0|-0.135|0.009||||||End of treatment||0.009|-0.135|
74095995|NCT00536263|147741665|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.017||||0.662|TWO_SIDED|95.0|-0.058|0.092|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.092|-0.058|0.662
74095996|NCT00536263|147741665|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.139|||<|0.001|TWO_SIDED|95.0|0.059|0.22|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.220|0.059|<0.001
74095997|NCT00536263|147741665|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.122|||||TWO_SIDED|90.0|-0.191|-0.053||||||24 weeks after EOT||-0.053|-0.191|
74095998|NCT00536263|147741666|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.019||||0.373|TWO_SIDED|95.0|-0.023|0.061|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.061|-0.023|0.373
74095999|NCT00536263|147741666|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.049||||0.04|TWO_SIDED|95.0|0.003|0.096|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.096|0.003|0.040
74096000|NCT00536263|147741666|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.03|||||TWO_SIDED|90.0|-0.072|0.011||||||End of treatment||0.011|-0.072|
74096001|NCT00536263|147741666|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.001||||0.969|TWO_SIDED|95.0|-0.041|0.043|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.043|-0.041|0.969
74096002|NCT00536263|147741666|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.045||||0.074|TWO_SIDED|95.0|-0.004|0.094|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.094|-0.004|0.074
74096003|NCT00536263|147741666|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.044|||||TWO_SIDED|90.0|-0.085|-0.003||||||24 weeks after EOT||-0.003|-0.085|
74096004|NCT00536263|147741667|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004||||0.724|TWO_SIDED|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.019|-0.027|0.724
74096005|NCT00536263|147741667|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.018||||0.243|TWO_SIDED|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.048|-0.012|0.243
74096006|NCT00536263|147741667|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.022|||||TWO_SIDED|90.0|-0.046|0.002||||||End of treatment||0.002|-0.046|
74096007|NCT00536263|147741667|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004||||0.724|TWO_SIDED|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.019|-0.027|0.724
74096008|NCT00536263|147741667|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.018||||0.232|TWO_SIDED|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.048|-0.012|0.232
73880523|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2024|TWO_SIDED|95.0|0.72|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.64|0.72|0.2024
74016925|NCT03237065|147585402|SUPERIORITY||Mean Difference (Final Values)|21.81|||<|0.0001|TWO_SIDED|95.0|17.66|25.95|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||25.95|17.66|<0.0001
74016926|NCT03237065|147585402|SUPERIORITY||Mean Difference (Final Values)|4.64||||0.2923|TWO_SIDED|95.0|-4.05|13.33|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||13.33|-4.05|0.2923
74016927|NCT03237065|147585402|SUPERIORITY||Mean Difference (Final Values)|19.56|||<|0.0001|TWO_SIDED|95.0|12.37|26.74|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||26.74|12.37|<0.0001
74016928|NCT03237065|147585402|SUPERIORITY||Mean Difference (Final Values)|33.05|||<|0.0001|TWO_SIDED|95.0|25.96|40.14|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||40.14|25.96|<0.0001
74016929|NCT03237065|147585402|SUPERIORITY||Mean Difference (Final Values)|21.82|||<|0.0001|TWO_SIDED|95.0|14.2|29.43|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||29.43|14.20|<0.0001
74016930|NCT03237065|147585402|SUPERIORITY||Mean Difference (Final Values)|9.03||||0.025|TWO_SIDED|95.0|1.16|16.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||16.90|1.16|0.0250
74016931|NCT03237065|147585403|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.5134|TWO_SIDED|95.0|-0.22|0.11|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.11|-0.22|0.5134
74016932|NCT03237065|147585403|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.7579|TWO_SIDED|95.0|-0.24|0.32|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.32|-0.24|0.7579
74096009|NCT00536263|147741667|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.022|||||TWO_SIDED|90.0|-0.046|0.002||||||24 weeks after EOT||0.002|-0.046|
74096010|NCT00536263|147741668|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.056||||0.219|TWO_SIDED|95.0|-0.033|0.145|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.145|-0.033|0.219
74096011|NCT00536263|147741668|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.126||||0.006|TWO_SIDED|95.0|0.037|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.216|0.037|0.006
74096012|NCT00536263|147741668|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.071|||||TWO_SIDED|90.0|-0.148|0.006||||||End of treatment||0.006|-0.148|
74096013|NCT00536263|147741668|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.082||||0.067|TWO_SIDED|95.0|-0.004|0.168|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.168|-0.004|0.067
74096014|NCT00536263|147741668|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.18|||<|0.001|TWO_SIDED|95.0|0.092|0.268|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.268|0.092|<0.001
74096015|NCT00536263|147741668|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.098|||||TWO_SIDED|90.0|-0.174|-0.021||||||24 weeks after EOT||-0.021|-0.174|
74016933|NCT03237065|147585403|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3169|TWO_SIDED|95.0|-0.41|0.14|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.14|-0.41|0.3169
74016934|NCT03237065|147585403|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.0018|TWO_SIDED|95.0|-0.76|-0.18|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.18|-0.76|0.0018
74045959|NCT01366534|147644144|OTHER||Vaccine Efficacy: Maentel-Haenzel Method|44.0||||0.0066|TWO_SIDED|95.0|20.7|60.4|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||60.4|20.7|0.0066
74045960|NCT01366534|147644144|OTHER||Vaccine Efficacy: Maentel-Haenzel Method|52.4||||0.0021|TWO_SIDED|95.0|25.4|69.6|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||69.6|25.4|0.0021
74045961|NCT01047436|147644163|SUPERIORITY_OR_OTHER||difference between treatments|26.7||||0.17|TWO_SIDED|95.0|-0.3|53.7|||Fisher Exact|||The sample size was not statistically determined in this initial trial with ArTimist. For the primary outcome analysis, the percentage of patients defined as having success were determined. The difference between ArTiMist and quinine, along with its 95% confidence interval (CI) were determined. The difference between treatments were compared using Fisher's Exact test||53.7|-0.3|0.17
74045962|NCT01047436|147644165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.7|TWO_SIDED|95.0|0.48|3.01|||Log Rank|||The time for the parasite count to fall by 90% (PCT90) was determined for each patient as the time in minutes/seconds, when the parasite count fell by 90% The PCT90 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.||3.01|0.48|0.70
74045963|NCT01047436|147644167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.76||95.0|0.34|2.18||Difference between survival curves compared by Log Rank test|Log Rank|||The PCT50 was determined for each patient as the time in minutes/seconds, when the parasite count fell by 50% The PCT50 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.||2.18|0.34|0.76
74045964|NCT00424099|147644187|OTHER|||||||0.16|||||||Kruskal-Wallis|||||||0.16
74045965|NCT00424099|147644188|OTHER|||||||0.45|||||||Kruskal-Wallis|||||||0.45
74045966|NCT03377452|147644189|SUPERIORITY||Mean Difference (Final Values)|7.26|STANDARD_ERROR_OF_MEAN|6.02||0.2313|TWO_SIDED|95.0|-4.71|19.22|||t-test, 2 sided|||||19.22|-4.71|0.2313
74045967|NCT03377452|147644190|SUPERIORITY||Mean Difference (Net)|-3.31|STANDARD_ERROR_OF_MEAN|0.81|<|0.001|TWO_SIDED|95.0|-4.91|-1.72|||Mixed Models Analysis||The parameter estimate is the change in the outcome from baseline to 3-months after the last intervention/control session for the intervention group versus the same change in the control group.|||-1.72|-4.91|<0.001
74045968|NCT00796003|147644203|SUPERIORITY_OR_OTHER||Overall Response Rate|26.5|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|90.0|14.6|41.6|||Binomial test|one-tailed 5% level at a significance level||Null Hypothesis: Overall Remission Rate = 5%||41.6|14.6|<0.0001
73880524|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.9||||0.1716|TWO_SIDED|95.0|0.76|4.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.79|0.76|0.1716
73880525|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.2||||0.0199|TWO_SIDED|95.0|1.2|8.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.51|1.20|0.0199
73880526|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|8.45||||0.0002|TWO_SIDED|95.0|2.8|25.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||25.54|2.80|0.0002
73880527|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4243|TWO_SIDED|95.0|0.57|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.77|0.57|0.4243
73880528|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1507|TWO_SIDED|95.0|0.78|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.09|0.78|0.1507
74016935|NCT03237065|147585403|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.0003|TWO_SIDED|95.0|-0.77|-0.24|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.24|-0.77|0.0003
74016936|NCT03237065|147585403|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.1063|TWO_SIDED|95.0|-0.5|0.05|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.05|-0.50|0.1063
74016937|NCT03237065|147585404|SUPERIORITY||Mean Difference (Final Values)|4.57||||0.2166|TWO_SIDED|95.0|-2.72|11.85|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||11.85|-2.72|0.2166
74016938|NCT03237065|147585404|SUPERIORITY||Mean Difference (Final Values)|-4.64||||0.2997|TWO_SIDED|95.0|-13.47|4.19|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||4.19|-13.47|0.2997
74016939|NCT03237065|147585404|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.9221|TWO_SIDED|95.0|-7.75|8.56|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||8.56|-7.75|0.9221
74016940|NCT03237065|147585404|SUPERIORITY||Mean Difference (Final Values)|-15.69||||0.0034|TWO_SIDED|95.0|-26.07|-5.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-5.32|-26.07|0.0034
74016941|NCT03237065|147585404|SUPERIORITY||Mean Difference (Final Values)|-22.54||||0.0002|TWO_SIDED|95.0|-33.93|-11.16|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-11.16|-33.93|0.0002
74045969|NCT05179057|147644214|SUPERIORITY|A logistic regression model included treatment, level of viremia at baseline (≥10,000 copies/mL or \<10,000 copies/mL adenovirus DNA), age (≥12 years or \<12 years), and absolute lymphocyte counts at baseline. The null hypothesis is that the true percentage for posoleucel plus SoC is less than or equal to the true percentage for placebo plus SoC, and the alternative hypothesis is that it is greater.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.26|3.69|||||Posoleucel versus Placebo|||3.69|0.26|
74045970|NCT02437162|147644241|SUPERIORITY||Percentage difference|2.586||||0.669|TWO_SIDED|95.0|-9.138|14.31|||Cochran-Mantel-Haenszel|||||14.310|-9.138|0.669
74045971|NCT02437162|147644241|SUPERIORITY||Percentage difference|-0.646||||0.913|TWO_SIDED|95.0|-12.18|10.887|||Cochran-Mantel-Haenszel|||||10.887|-12.180|0.913
74045972|NCT04338321|147644278|SUPERIORITY||Mean Difference (Final Values)|9.44|||=|0.003|TWO_SIDED|95.0|3.19|15.68|||Cochran-Mantel-Haenszel|||||15.68|3.19|=0.003
74096016|NCT00536263|147741669|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.001||||0.995|TWO_SIDED|95.0|-0.039|0.041|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.041|-0.039|0.995
74096017|NCT00536263|147741669|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.054||||0.031|TWO_SIDED|95.0|0.005|0.103|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.103|0.005|0.031
74096018|NCT00536263|147741669|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.053|||||TWO_SIDED|90.0|-0.094|-0.012||||||End of treatment||-0.012|-0.094|
74096019|NCT00536263|147741669|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.024||||0.389|TWO_SIDED|95.0|-0.03|0.078|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.078|-0.030|0.389
74096020|NCT00536263|147741669|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.121|||<|0.001|TWO_SIDED|95.0|0.058|0.184|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.184|0.058|<0.001
74096021|NCT00536263|147741669|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.097|||||TWO_SIDED|90.0|-0.152|-0.041||||||24 weeks after EOT||-0.041|-0.152|
74096022|NCT00536263|147741670|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0||||0.991|TWO_SIDED|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.012|-0.012|0.991
74096023|NCT00536263|147741670|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.013||||0.181|TWO_SIDED|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.033|-0.006|0.181
74096024|NCT00536263|147741670|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.013|||||TWO_SIDED|90.0|-0.03|0.003||||||End of treatment||0.003|-0.030|
74096025|NCT00536263|147741670|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0||||0.971|TWO_SIDED|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.012|-0.012|0.971
74096026|NCT00536263|147741670|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.013||||0.179|TWO_SIDED|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.033|-0.006|0.179
74096027|NCT00536263|147741670|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.013|||||TWO_SIDED|90.0|-0.03|0.003||||||24 weeks after EOT||0.003|-0.030|
74096028|NCT00536263|147741671|SUPERIORITY_OR_OTHER|||||||0.991|||||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference \& corresponding 95% confidence interval were not applicable."||End of treatment||||0.991
74096029|NCT00536263|147741671|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.004||||0.322|TWO_SIDED|95.0|-0.004|0.013|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.013|-0.004|0.322
74096030|NCT00536263|147741671|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004|||||TWO_SIDED|90.0|-0.012|0.003||||||End of treatment||0.003|-0.012|
74045973|NCT03375203|147644303|OTHER||Back-transformed Least Square Mean Ratio|0.88|||=|0.346|TWO_SIDED|90.0|0.7|1.1|||ANCOVA|||||1.10|0.70|= 0.346
74045974|NCT03375203|147644303|OTHER||Back-transformed Least Square Mean Ratio|0.64|||=|0.001|TWO_SIDED|90.0|0.51|0.81|||ANCOVA|||||0.81|0.51|= 0.001
74045975|NCT03375203|147644303|OTHER||Back-transformed Least Square Mean Ratio|0.51|||<|0.001|TWO_SIDED|90.0|0.41|0.64|||ANCOVA|||||0.64|0.41|< 0.001
74045976|NCT03375203|147644303|OTHER|||||||0|||||||MCP-mod|||||||0.000
74096031|NCT00536263|147741671|SUPERIORITY_OR_OTHER|||||||0.991||95.0|||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference \& corresponding 95% confidence interval were not applicable."||24 weeks after EOT||||0.991
74096032|NCT00536263|147741671|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.009||||0.157|TWO_SIDED|95.0|-0.003|0.021|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.021|-0.003|0.157
74096033|NCT00536263|147741671|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.009|||||TWO_SIDED|90.0|-0.019|0.001||||||24 weeks after EOT||0.001|-0.019|
74096034|NCT00536263|147741672|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||0.014
74096035|NCT00536263|147741672|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||<0.001
74096036|NCT00536263|147741672|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||0.010
74096037|NCT00536263|147741672|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.2||||0.631|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.||||0.8|-1.2|0.631
74096038|NCT00536263|147741672|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.3||||0.617|TWO_SIDED|95.0|-1.4|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.||||0.8|-1.4|0.617
74045977|NCT03107793|147644350|SUPERIORITY||||||=|0.0871|||||||Cochran-Mantel-Haenszel|||||||= 0.0871
74045978|NCT03321526|147644374|SUPERIORITY|||||||0.5355|TWO_SIDED||||||Log Rank|||||||0.5355
74096039|NCT00536263|147741672|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||||1.1|-1.1|
74096040|NCT04135196|147741705|OTHER|||||||0.119|||||||Regression, Linear|||"The power analysis for the overall study was based on 12-month change in UD iBMC. The power calculation, based on pilot data, determined that 20 participants per group would have 80% power to detect a 1.0±1.1% change.~The null hypothesis was that change in UD iBMC was not proportional to strain magnitude. Raw change in iBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group."|"Overall model fit: R\^2=0.101, F=2.244, df1=2, df2=40, p=0.119~Contrast between the low strain magnitude group and the control group: B=0.015, Std. Error of estimate of B=0.007, Beta=0.374, t=2.114, p=0.041, 95% CI of B: \[0.001, 0.030\]~Contrast between the high strain magnitude group and the control group: B=0.009, Std. Error of estimate of B=0.007, Beta=0.221, t=1.247, p=0.220, 95% CI of B: \[-0.005, 0.022\]"|||0.119
74016942|NCT03237065|147585404|SUPERIORITY||Mean Difference (Final Values)|-24.81|||<|0.0001|TWO_SIDED|95.0|-35.42|-14.21|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-14.21|-35.42|<0.0001
74016943|NCT03237065|147585405|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.3048|TWO_SIDED|95.0|-0.1|0.03|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.03|-0.10|0.3048
74016944|NCT03237065|147585405|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.1641|TWO_SIDED|95.0|-0.02|0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.13|-0.02|0.1641
74016945|NCT03237065|147585405|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.1333|TWO_SIDED|95.0|-0.02|0.12|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.12|-0.02|0.1333
74016946|NCT03237065|147585405|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.9385|TWO_SIDED|95.0|-0.17|0.16|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.16|-0.17|0.9385
74016947|NCT03237065|147585405|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.0408|TWO_SIDED|95.0|0.0|0.14|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.14|0.00|0.0408
74016948|NCT03237065|147585405|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.2376|TWO_SIDED|95.0|-0.03|0.12|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.12|-0.03|0.2376
74016949|NCT03237065|147585407|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.0882|TWO_SIDED|95.0|-0.67|0.05|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.05|-0.67|0.0882
74016950|NCT03237065|147585407|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0941|TWO_SIDED|95.0|-0.74|0.06|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.06|-0.74|0.0941
74016951|NCT03237065|147585407|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.0628|TWO_SIDED|95.0|-0.02|0.66|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.66|-0.02|0.0628
74016952|NCT03237065|147585407|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.0056|TWO_SIDED|95.0|0.14|0.79|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.79|0.14|0.0056
74045979|NCT02808507|147644412|OTHER||Treatment initiation ratio|1.04||||0.73|TWO_SIDED|95.0|0.8|1.3|||See above comments|||The primary analysis was based on the facility-level rate ratio. We first calculated an unadjusted ratio of the treatment initiation rates between the two arms and the corresponding 95% CI. We first fit a Poisson regression to the facility-level counts and the district and historical volume covariates. The residuals ratios, calculated as the ratio of the observed over the expected counts, were then used in the second stage to estimate the between-arm rate ratio and the corresponding 95% CI.||1.3|0.80|0.73
74096041|NCT04135196|147741705|OTHER||||||<|0.01|||||||Regression, Linear|||The null hypothesis was that change in UD iBMC was not proportional to strain rate. Raw change in iBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.438, F=12.836, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.036, Std. Error of estimate of B=0.009, Beta=0.599, t=4.050, p=\<0.001, 95% CI of B: \[0.018, 0.055\]~Contrast between the high strain rate group and the control group: B=0.041, Std. Error of estimate of B=0.009, Beta=0.678, t=4.589, p=\<0.001, 95% CI of B: \[0.023, 0.060\]"|||<0.01
74096042|NCT04135196|147741706|OTHER|||||||0.809|||||||Regression, Linear|||The null hypothesis was that change in UD cBMC was not proportional to strain magnitude. Raw change in cBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.011, F=0.213, df1=2, df2=40, p=0.809~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.006, Beta=0.039, t=0.209, p=0.836, 95% CI of B: \[-0.012, 0.014\]~Contrast between the high strain magnitude group and the control group: B=-0.002, Std. Error of estimate of B=0.006, Beta=-0.077, t=-0.412, p=0.682, 95% CI of B: \[-0.015, 0.010\]"|||0.809
74096043|NCT04135196|147741706|OTHER|||||||0.155|||||||Regression, Linear|||The null hypothesis was that change in UD cBMC was not proportional to strain rate. Raw change in cBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.107, F=1.971, df1=2, df2=33, p=0.155~Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.008, Beta=0.284, t=1.526, p=0.137, 95% CI of B: \[-0.004, 0.027\]~Contrast between the high strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.008, Beta=0.342, t=1.837, p=0.075, 95% CI of B: \[-0.002, 0.030\]"|||0.155
74096044|NCT04135196|147741707|OTHER|||||||0.991|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMC was not proportional to strain magnitude. Raw change in ecBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=\<0.001, F=0.009, df1=2, df2=40, p=0.991~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.009, Beta=0.025, t=0.133, p=0.894, 95% CI of B: \[-0.016, 0.018\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.008, Beta=0.012, t=0.063, p=0.950, 95% CI of B: \[-0.016, 0.017\]"|||0.991
74096045|NCT04135196|147741707|OTHER|||||||0.018|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMC was not proportional to strain rate. Raw change in ecBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.216, F=4.548, df1=2, df2=33, p=0.018~Contrast between the low strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.455, t=2.607, p=0.014, 95% CI of B: \[0.006, 0.052\]~Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.447, t=2.563, p=0.015, 95% CI of B: \[0.006, 0.052\]"|||0.018
74096046|NCT04135196|147741708|OTHER|||||||0.153|||||||Regression, Linear|||The null hypothesis was that change in UD tBMC was not proportional to strain magnitude. Raw change in tBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.090, F=1.968, df1=2, df2=40, p=0.153~Contrast between the low strain magnitude group and the control group: B=0.007, Std. Error of estimate of B=0.003, Beta=0.352, t=1.973, p=0.055, 95% CI of B: \[0.000, 0.013\]~Contrast between the high strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.003, Beta=0.156, t=0.874, p=0.387, 95% CI of B: \[-0.004, 0.009\]"|||0.153
74016953|NCT03237065|147585407|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.0492|TWO_SIDED|95.0|0.0|0.55|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.55|0.00|0.0492
74016954|NCT03237065|147585407|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.0882|TWO_SIDED|95.0|-0.05|0.64|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.64|-0.05|0.0882
74016955|NCT03237065|147585408|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.6568|TWO_SIDED|95.0|-35.3|22.3|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.3|-35.3|0.6568
74016956|NCT03237065|147585408|SUPERIORITY||Mean Difference (Final Values)|-24.2||||0.4929|TWO_SIDED|95.0|-94.0|45.5|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||45.5|-94.0|0.4929
74096047|NCT04135196|147741708|OTHER|||||||0.001|||||||Regression, Linear|||The null hypothesis was that change in UD tBMC was not proportional to strain rate. Raw change in tBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.331, F=8.152, df1=2, df2=33, p=0.001~Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.004, Beta=0.473, t=2.930, p=0.006, 95% CI of B: \[0.004, 0.020\]~Contrast between the high strain rate group and the control group: B=0.016, Std. Error of estimate of B=0.004, Beta=0.617, t=3.828, p=0.001, 95% CI of B: \[0.008, 0.025\]"|||0.001
74096048|NCT04135196|147741709|OTHER|||||||0.84|||||||Regression, Linear|||The null hypothesis was that change in UD iBMD was not proportional to strain magnitude. Raw change in iBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.009, F=0.176, df1=2, df2=40, p=0.840~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.001, Beta=0.091, t=0.489, p=0.628, 95% CI of B: \[-0.002, 0.003\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.001, Beta=0.101, t=0.544, p=0.589, 95% CI of B: \[-0.002, 0.003\]"|||0.840
74096049|NCT04135196|147741709|OTHER||||||<|0.001|||||||Regression, Linear|||The null hypothesis was that change in UD iBMD was not proportional to strain rate. Raw change in iBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.563, F=21.225, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.009, Std. Error of estimate of B=0.002, Beta=0.739, t=5.669, p=\<0.001, 95% CI of B: \[0.005, 0.012\]~Contrast between the high strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.716, t=5.495, p=\<0.001, 95% CI of B: \[0.005, 0.012\]"|||<0.001
74096050|NCT04135196|147741710|OTHER|||||||0.202|||||||Regression, Linear|||The null hypothesis was that change in UD cBMD was not proportional to strain magnitude. Raw change in cBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.077, F=1.665, df1=2, df2=40, p=0.202~Contrast between the low strain magnitude group and the control group: B=-0.005, Std. Error of estimate of B=0.003, Beta=-0.303, t=-1.689, p=0.099, 95% CI of B: \[-0.012, 0.001\]~Contrast between the high strain magnitude group and the control group: B=-0.004, Std. Error of estimate of B=0.003, Beta=-0.266, t=-1.484, p=0.146, 95% CI of B: \[-0.010, 0.002\]"|||0.202
74096051|NCT04135196|147741710|OTHER|||||||0.381|||||||Regression, Linear|||The null hypothesis was that change in UD cBMD was not proportional to strain rate. Raw change in cBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.057, F=0.995, df1=2, df2=33, p=0.381~Contrast between the low strain rate group and the control group: B=0.004, Std. Error of estimate of B=0.003, Beta=0.254, t=1.327, p=0.194, 95% CI of B: \[-0.002, 0.011\]~Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.003, Beta=0.038, t=0.200, p=0.843, 95% CI of B: \[-0.006, 0.008\]"|||0.381
74096052|NCT04135196|147741711|OTHER|||||||0.697|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMD was not proportional to strain magnitude. Raw change in ecBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.018, F=0.365, df1=2, df2=40, p=0.697~Contrast between the low strain magnitude group and the control group: B=-0.004, Std. Error of estimate of B=0.004, Beta=-0.158, t=-0.854, p=0.398, 95% CI of B: \[-0.012, 0.005\]~Contrast between the high strain magnitude group and the control group: B=-0.002, Std. Error of estimate of B=0.004, Beta=-0.078, t=-0.423, p=0.675, 95% CI of B: \[-0.010, 0.006\]"|||0.697
74096053|NCT04135196|147741711|OTHER|||||||0.018|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMD was not proportional to strain rate. Raw change in ecBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.215, F=4.516, df1=2, df2=33, p=0.018~Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.005, Beta=0.484, t=2.773, p=0.009, 95% CI of B: \[0.004, 0.0524\]~Contrast between the high strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.005, Beta=0.406, t=2.325, p=0.026, 95% CI of B: \[0.001, 0.022\]"|||0.018
74096054|NCT04135196|147741712|OTHER|||||||0.073|||||||Regression, Linear|||The null hypothesis was that change in UD tBMD was not proportional to strain magnitude. Raw change in tBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.123, F=2.799, df1=2, df2=40, p=0.073~Contrast between the low strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.001, Beta=0.413, t=2.361, p=0.023, 95% CI of B: \[0.000, 0.006\]~Contrast between the high strain magnitude group and the control group: B=0.002, Std. Error of estimate of B=0.001, Beta=0.198, t=1.129, p=0.265, 95% CI of B: \[-0.001, 0.004\]"|||0.073
74096055|NCT04135196|147741712|OTHER||||||<|0.001|||||||Regression, Linear|||The null hypothesis was that change in UD tBMD was not proportional to strain rate. Raw change in tBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.480, F=15.256, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.590, t=4.153, p=\<0.001, 95% CI of B: \[0.004, 0.012\]~Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.002, Beta=0.734, t=5.164, p=\<0.001, 95% CI of B: \[0.006, 0.014\]"|||<0.001
74096056|NCT04135196|147741713|OTHER|||||||0.101|||||||Regression, Linear|||The null hypothesis was that change in UD iBV was not proportional to strain magnitude. Raw change in iBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.108, F=2.428, df1=2, df2=40, p=0.101~Contrast between the low strain magnitude group and the control group: B=0.053, Std. Error of estimate of B=0.024, Beta=0.388, t=2.200, p=0.034, 95% CI of B: \[0.004, 0.101\]~Contrast between the high strain magnitude group and the control group: B=0.029, Std. Error of estimate of B=0.022, Beta=0.226, t=1.280, p=0.208, 95% CI of B: \[-0.017, 0.074\]"|||0.101
74016957|NCT03237065|147585408|SUPERIORITY||Mean Difference (Final Values)|-91.7||||0.0113|TWO_SIDED|95.0|-162.3|-21.1|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-21.1|-162.3|0.0113
74016958|NCT03237065|147585408|SUPERIORITY||Mean Difference (Final Values)|-240.4|||<|0.0001|TWO_SIDED|95.0|-318.4|-162.3|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-162.3|-318.4|<0.0001
74016959|NCT03237065|147585408|SUPERIORITY||Mean Difference (Final Values)|-135.1|||<|0.0001|TWO_SIDED|95.0|-196.1|-74.0|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-74.0|-196.1|<0.0001
74016960|NCT03237065|147585408|SUPERIORITY||Mean Difference (Final Values)|-67.7||||0.0039|TWO_SIDED|95.0|-113.2|-22.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-22.2|-113.2|0.0039
74016961|NCT03237065|147585409|SUPERIORITY||Mean Difference (Final Values)|24.2||||0.0503|TWO_SIDED|95.0|0.0|48.5|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||48.5|-0.0|0.0503
74016962|NCT03237065|147585409|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.5794|TWO_SIDED|95.0|-5.5|9.8|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||9.8|-5.5|0.5794
74016963|NCT03237065|147585409|SUPERIORITY||Mean Difference (Final Values)|-62.2|||<|0.0001|TWO_SIDED|95.0|-70.1|-54.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-54.3|-70.1|<0.0001
74045980|NCT02808507|147644413|OTHER||Treatment initiation ratio|1.05||||0.68|TWO_SIDED|95.0|0.97|1.13|||Poisson regression||Adjusted for district, study phase and clinic random effect.|The primary outcome of the study was the comparative number of people with incident TB diagnosed and started on treatment at study clinics during the two study periods, excluding the six-month washout period. The number of people starting treatment for incident TB was calculated by performing a review of paper and electronic medical records at each clinic on a quarterly basis during the study.||1.13|0.97|0.68
74045981|NCT02808507|147644414|OTHER||Prevalence ratio|1.0||||0.8|TWO_SIDED|95.0|0.51|1.95||"The pre-specified secondary study outcome was the number of Xpert-based TB diagnoses made among enrolled contacts (secondary cases) by arm."|Poisson regression||Adjusted for study phase and district|||1.95|0.51|0.80
74045982|NCT01989572|147644419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.528|||||||Log Rank|stratifying on HLA-A2 status, site of metastases and number of metastatic lesions.||||||0.528
74045983|NCT01989572|147644420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Log Rank|stratifying on HLA-A2 status, site of metastases, and number of metastatic lesions||||||0.131
74045984|NCT01989572|147644421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Log Rank|stratifying on GM-CSF, site of metastases and number of metastatic lesions||||||0.60
74045985|NCT01989572|147644422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||stratifying on GM-CSF, site of metastases and number of metastatic lesions|Log Rank|||||||0.71
74045986|NCT01989572|147644423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status||||0.88
74045987|NCT01989572|147644423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with negative HLA-A2 status||||0.69
74045988|NCT01989572|147644424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status||||0.91
74045989|NCT01989572|147644424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparisons in patients with negative HLA-A2 status||||0.13
74045990|NCT02280096|147644425|SUPERIORITY||t-boostrap|0.028||||0.028|TWO_SIDED||||||t-test, 1 sided|||||||0.028
74045991|NCT02280096|147644426|SUPERIORITY||t-boostrap|0.001||||0.001|ONE_SIDED||||||t-test, 1 sided|||||||0.001
74016964|NCT03237065|147585409|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.0001|TWO_SIDED|95.0|-10.4|-3.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-3.5|-10.4|0.0001
74016965|NCT03237065|147585409|SUPERIORITY||Mean Difference (Final Values)|-5.8||||0.0008|TWO_SIDED|95.0|-9.1|-2.4|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-2.4|-9.1|0.0008
74016966|NCT03237065|147585409|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.004|TWO_SIDED|95.0|-8.1|-1.6|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-1.6|-8.1|0.0040
74016967|NCT03237065|147585410|SUPERIORITY||Risk Difference (RD)|-10.7||||0.009|TWO_SIDED|95.0|-18.8|-2.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.||-2.6|-18.8|0.0090
74016968|NCT01764633|147585504|SUPERIORITY||Hazard Ratio (HR)|0.85|||<|0.0001|TWO_SIDED|95.0|0.79|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|The primary endpoint was compared between treatment groups at a significance level of 0.05.||0.92|0.79|< 0.0001
74016969|NCT01764633|147585505|SUPERIORITY||Hazard Ratio (HR)|0.8|||<|0.0001|TWO_SIDED|95.0|0.73|0.88|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary endpoint reached statistical significance at the 0.05 level, the key secondary endpoint (composite of cardiovascular death, myocardial infarction, and stroke) was tested at a significance level of 0.05.||0.88|0.73|< 0.0001
74016970|NCT01764633|147585506|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.6188|TWO_SIDED|95.0|0.88|1.25|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary and key secondary endpoints reached a statistical significance level of 0.05, then the endpoint of cardiovascular death was tested at a significance level of 0.05.||1.25|0.88|0.6188
74016971|NCT01764633|147585507|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5368|TWO_SIDED|95.0|0.91|1.19|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints at an overall significant level of 0.01 by applying the Hochberg method.||1.19|0.91|0.5368
74016972|NCT01764633|147585508|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.65|0.82|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.82|0.65|< 0.0001
74016973|NCT01764633|147585509|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0101|TWO_SIDED|95.0|0.66|0.95|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.95|0.66|0.0101
74045992|NCT02280096|147644427|SUPERIORITY||t-boostrap|0.016||||0.016|TWO_SIDED||||||t-test, 1 sided|||||||0.016
74045993|NCT02280096|147644428|SUPERIORITY||t-boostrap|0.64||||0.64|ONE_SIDED||||||t-test, 1 sided|||Reading speed||||0.64
74045994|NCT02280096|147644428|SUPERIORITY||t-boostrap|0.43||||0.43|TWO_SIDED||||||t-test, 1 sided|||Count speed||||0.43
74045995|NCT02280096|147644428|SUPERIORITY||t-boostrap|0.9||||0.9|TWO_SIDED||||||t-test, 1 sided|||Alternation||||0.9
74045996|NCT02280096|147644429|SUPERIORITY||t-boostrap|0.83||||0.83|TWO_SIDED||||||t-test, 1 sided|||||||0.83
74045997|NCT02280096|147644430|SUPERIORITY||t-boostrap|0.92||||0.92|ONE_SIDED||||||t-test, 1 sided|||||||0.92
74045998|NCT02280096|147644431|SUPERIORITY||t-boostrap|0.017||||0.017|TWO_SIDED||||||t-test, 1 sided|||Total moves||||0.017
74045999|NCT02280096|147644431|SUPERIORITY||t-boostrap|0.01||||0.01|TWO_SIDED||||||t-test, 1 sided|||Correct moves||||0.010
74046000|NCT02280096|147644432|SUPERIORITY||t-boostrap|0.001||||0.001|TWO_SIDED||||||t-test, 1 sided|||Execution time||||0.001
74046001|NCT02280096|147644432|SUPERIORITY||t-boostrap|0.001||||0.001|TWO_SIDED||||||t-test, 1 sided|||Problem-solving time||||0.001
74096057|NCT04135196|147741713|OTHER|||||||0.344|||||||Regression, Linear|||The null hypothesis was that change in UD iBV was not proportional to strain rate. Raw change in iBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.063, F=01.103, df1=2, df2=33, p=0.344~Contrast between the low strain rate group and the control group: B=0.015, Std. Error of estimate of B=0.025, Beta=0.113, t=0.595, p=0.556, 95% CI of B: \[-0.036, 0.065\]~Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: \[-0.014, 0.089\]"|||0.344
74096058|NCT04135196|147741714|OTHER|||||||0.676|||||||Regression, Linear|||The null hypothesis was that change in UD cBV was not proportional to strain magnitude. Raw change in cBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.019, F=0.395, df1=2, df2=40, p=0.676~Contrast between the low strain magnitude group and the control group: B=0.012, Std. Error of estimate of B=0.015, Beta=0.146, t=0.787, p=0.436, 95% CI of B: \[-0.019, 0.042\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.014, Beta=0.013, t=0.070, p=0.945, 95% CI of B: \[-0.028, 0.029\]"|||0.676
74096059|NCT04135196|147741714|OTHER|||||||0.289|||||||Regression, Linear|||The null hypothesis was that change in UD cBV was not proportional to strain rate. Raw change in cBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|Overall model fit: R\^2=0.072, F=1.288, df1=2, df2=33, p=0.289 Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.018, Beta=0.154, t=0.814, p=0.422, 95% CI of B: \[-0.022, 0.051\] Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.018, Beta=0.304, t=1.604, p=0.118, 95% CI of B: \[-0.008, 0.066\]|||0.289
74096060|NCT04135196|147741715|OTHER|||||||0.096|||||||Regression, Linear|||The null hypothesis was that change in UD ecBV was not proportional to strain magnitude. Raw change in ecBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.111, F=2.491, df1=2, df2=40, p=0.096~Contrast between the low strain magnitude group and the control group: B=0.026, Std. Error of estimate of B=0.012, Beta=0.391, t=2.222, p=0.032, 95% CI of B: \[0.032, 0.049\]~Contrast between the high strain magnitude group and the control group: B=0.015, Std. Error of estimate of B=0.011, Beta=0.240, t=1.362, p=0.181, 95% CI of B: \[-0.007, 0.037\]"|||0.096
74096061|NCT04135196|147741715|OTHER|||||||0.344|||||||Regression, Linear|||The null hypothesis was that change in UD ecBV was not proportional to strain rate. Raw change in ecBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.063, F=1.103, df1=2, df2=33, p=0.344~Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.015, Beta=0.113, t=0.595, p=0.556, 95% CI of B: \[-0.036, 0.065\]~Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: \[-0.014, 0.089\]"|||0.344
74096062|NCT04135196|147741716|OTHER|||||||0.332|||||||Regression, Linear|||The null hypothesis was that change in UD tBV was not proportional to strain magnitude. Raw change in tBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.054, F=1.132, df1=2, df2=40, p=0.332~Contrast between the low strain magnitude group and the control group: B=0.016, Std. Error of estimate of B=0.011, Beta=0.271, t=1.493, p=0.143, 95% CI of B: \[-0.006, 0.039\]~Contrast between the high strain magnitude group and the control group: B=0.007, Std. Error of estimate of B=0.010, Beta=0.115, t=635, p=0.529, 95% CI of B: \[-0.014, 0.028\]"|||0.332
74096063|NCT04135196|147741716|OTHER|||||||0.399|||||||Regression, Linear|||The null hypothesis was that change in UD tBV was not proportional to strain rate. Raw change in tBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.054, F=0.946, df1=2, df2=33, p=0.399~Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.012, Beta=0.119, t=0.619, p=0.540, 95% CI of B: \[-0.017, 0.032\]~Contrast between the high strain rate group and the control group: B=0.017, Std. Error of estimate of B=0.012, Beta=0.264, t=1.375, p=0.178, 95% CI of B: \[-0.008, 0.042\]"|||0.399
74016974|NCT01764633|147585510|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.71|0.86|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.86|0.71|< 0.0001
74096064|NCT04135196|147741717|OTHER|||||||||||||||||The null hypothesis was that change in cortical thickness was not proportional to strain magnitude. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~There were no significant relationships found between change in cortical thickness and strain magnitude group at any time point (p\>0.05)."|||
74016975|NCT01764633|147585511|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8179|TWO_SIDED|95.0|0.86|1.13|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||1.13|0.86|0.8179
74096065|NCT04135196|147741717|OTHER|||||||||||||||||The null hypothesis was that change in cortical thickness was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~At 3 months, there was a significant overall linear relationship between change in cortical thickness and strain rate group. Additionally, the coefficient representing the contrast between the control group and the high strain rate group was also significant. All other comparisons were not statistically significant (p\>0.05).~Stats for 3 months:~Overall model fit: R\^2=0.258, F=4.519, df1=2, df2=26, p=0.021~Contrast between the high strain rate group and the control group: B=0.036, Std. Error of estimate of B=0.012, Beta=0.574, t=2.967, p=0.006, 95% CI of B: \[0.011, 0.061\]"|||
74096066|NCT04135196|147741718|OTHER|||||||||||||||||The null hypothesis was that change in bone volume fraction (BV/TV) was not proportional to strain magnitude. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~At 9 months, there was a significant overall linear relationship between change in BV/TV and strain magnitude group. Additionally, the coefficient representing the contrast between the control group and the low strain magnitude group was also significant. All other comparisons were not statistically significant (p\>0.05).~Stats for 9 months:~Overall model fit: R\^2=0.240, F=5.057, df1=2, df2=32, p=0.012~Contrast between the low strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.001, Beta=0.562, t=3.180, p=0.003, 95% CI of B: \[0.001, 0.006\]"|||
74096067|NCT04135196|147741718|OTHER||||||>|0.05|||||||Regression, Linear|||The null hypothesis was that change in bone volume fraction (BV/TV) was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.|||>0.05
74096068|NCT03118570|147741785|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.644||||||Analysis is based on a log transformed analysis of covariance (ANCOVA) model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.644
74096069|NCT03118570|147741785|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.485||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.485
74096070|NCT03118570|147741785|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.404||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.404
74096071|NCT03118570|147741786|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.006
74096072|NCT03118570|147741786|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.190
74096073|NCT03118570|147741786|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.704||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.704
74096074|NCT03118570|147741787|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.011
74096075|NCT03118570|147741787|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.047||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.047
74016976|NCT01764633|147585512|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0035|TWO_SIDED|95.0|0.65|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.92|0.65|0.0035
74096076|NCT03118570|147741787|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.756||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.756
74016977|NCT04418765|147585529|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.9|-2.5||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 1 of testing order.|Mixed Models Analysis|||Analysis was performed using a restricted maximum likelihood (REML)-based mixed model for repeated measurements (MMRM) with month (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy was applied to ensure protection of the type 1 error.||-2.5|-3.9|<0.0001
74016978|NCT04418765|147585529|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.4|-2.0||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 3 of testing order.|Mixed Models Analysis|||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-2.0|-3.4|<0.0001
74016979|NCT04418765|147585530|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|6.58|||<|0.0001|TWO_SIDED|95.0|4.41|10.01||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 2 of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||10.01|4.41|<0.0001
74016980|NCT04418765|147585530|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|4.91|||<|0.0001|TWO_SIDED|95.0|3.29|7.47||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 4 of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||7.47|3.29|<0.0001
74046002|NCT02418585|147644444|SUPERIORITY||Difference of Least Square (LS) Means|-4.0|STANDARD_ERROR_OF_MEAN|1.69|=|0.02|TWO_SIDED|95.0|-7.31|-0.64|||Mixed Model for Repeated Measures|||||-0.64|-7.31|=0.020
74046003|NCT02418585|147644445|SUPERIORITY||Difference of Least Square (LS) Means|-3.5|||=|0.034|TWO_SIDED|95.0|-6.67|-0.26|||ANCOVA|||||-0.26|-6.67|=0.034
74046004|NCT02040857|147644460|OTHER|Exact binomial test||||||0.0011|||||||Exact binomial test|||Primary objective is treatment discontinuation rate at 2 yr for patients receiving Palbociclib therapy. If the true rate of discontinuation by two years is 48% or higher, treatment duration will be considered not feasible and not worthy of further study. If the rate of discontinuation is 33.3% or less, the 2 yr duration will be deemed feasible and worthy of further study. Using a one-sided alpha = 0.025, there is \> 90% power to reject the null hypothesis in favor of feasibility.||||0.0011
74096077|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.329||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.329
74046005|NCT02057068|147644471|SUPERIORITY||||||<|0.001|||||||ANOVA|Intention to treat analysis with last observation carried forward|||Partial Eta Squared = .282|||<.001
74016981|NCT04418765|147585531|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-4.5|-3.0||Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 5a of testing order.|Mixed Models Analysis|Testing continued only, if the previous comparison was statistically significant.||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-3.0|-4.5|<0.0001
74016982|NCT04418765|147585531|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-3.8|-2.2||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6a of testing order.|Mixed Models Analysis|Testing continued only, if the previous comparison was statistically significant.||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-2.2|-3.8|<0.0001
74016983|NCT04418765|147585532|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|11.43|||<|0.0001|TWO_SIDED|95.0|5.22|30.15||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 5b of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||30.15|5.22|<0.0001
74046006|NCT02057068|147644472|SUPERIORITY|Intention to treat analysis with last observation carried forward|||||>|0.05|||||||ANOVA|||||||>.05
74046007|NCT02057068|147644473|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
74046008|NCT00654420|147644481|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.268|TWO_SIDED|95.0|0.47|1.57|||Finkelstein Proportional Hazards Model|||Finkelstein proportional hazards model for interval-censored data was used to assess treatment effect on PFS in Phase II. The hazard ratio with 95% confidence interval for the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported.||1.57|0.47|0.268
74046009|NCT00654420|147644482|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.879|TWO_SIDED|95.0|0.78|2.64|||Regression, Cox|||The treatment difference in survival between treatment groups was assessed by Cox regression. The estimated hazard ratio for treatment of the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported from the Cox model.||2.64|0.78|0.879
74046010|NCT00654420|147644483|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8||||0.721|TWO_SIDED|95.0|-15.9|9.4|||Miettinen & Nurminen Method|||Miettinen and Nurminen's method for stratified data was used for comparison of percentage of participants with objective response (ORR) between the two treatment groups. Response rate calculation was based on full follow-up.||9.4|-15.9|0.721
74096078|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.953||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.953
74096079|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.795||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.795
74096080|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.644||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.644
74096081|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.485||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.485
74096082|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.404||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.404
74096083|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.827||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.827
74096084|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.459||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.459
74096085|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.022||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.022
74096086|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.821||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.821
74096087|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.911||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.911
74096088|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.152||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.152
74096089|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.668||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.668
74096090|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.109||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.109
74096091|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.358||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.358
74096092|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.742||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.742
74096093|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.567||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.567
74096094|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.43||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.430
74096095|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.634||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.634
73880529|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0449|TWO_SIDED|95.0|1.02|6.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.60|1.02|0.0449
73880530|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.68||||0.2759|TWO_SIDED|95.0|0.66|4.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.24|0.66|0.2759
74096096|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.146||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.146
74096097|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.521||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.521
74096098|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.991||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.991
74096099|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.069||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.069
74046011|NCT00471276|147644497|SUPERIORITY_OR_OTHER||Objective Response Rate (percent)|8.4|||||TWO_SIDED|95.0|3.5|16.6|||Exact 2-sided confidence interval|||||16.6|3.5|
74046012|NCT00471276|147644498|SUPERIORITY_OR_OTHER||Objective Response Rate (percent)|10.8|||||TWO_SIDED|95.0|5.1|19.6|||Exact 2-sided confidence interval|||||19.6|5.1|
74046013|NCT00655811|147644522|SUPERIORITY||||||<|0.05|||||||ANOVA|||One-way anova was used to compare the mean COVAS values between groups.||||<0.05
74046014|NCT00655811|147644522|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.550
74046015|NCT00655811|147644522|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
74046016|NCT00655811|147644522|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
74046017|NCT00655811|147644523|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
74046018|NCT00655811|147644523|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
74046019|NCT00655811|147644523|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
74046020|NCT00655811|147644524|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
74046021|NCT00814307|147644525|SUPERIORITY_OR_OTHER||Percent difference|39.04|||<|0.0001|TWO_SIDED|95.0|29.12|48.95||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||48.95|29.12|<0.0001
74046022|NCT00814307|147644525|SUPERIORITY_OR_OTHER||Percent difference|33.08|||<|0.0001|TWO_SIDED|95.0|23.04|43.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||43.13|23.04|<0.0001
74046023|NCT00814307|147644526|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.27||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.||-0.27|-0.50|<.0001
74046024|NCT00814307|147644526|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.2||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.||-0.20|-0.43|<0.0001
74046025|NCT00814307|147644527|SUPERIORITY_OR_OTHER||Percent difference|5.24||||0.0728|TWO_SIDED|95.0|-0.49|10.96||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.||10.96|-0.49|0.0728
74046026|NCT00814307|147644527|SUPERIORITY_OR_OTHER||Percent difference|1.31||||0.6193|TWO_SIDED|95.0|-3.85|6.46||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.||6.46|-3.85|0.6193
74046027|NCT03039192|147644570|SUPERIORITY||Difference of Least Square Means|-3.8|STANDARD_ERROR_OF_MEAN|1.39||0.006|TWO_SIDED|95.0|-6.56|-1.09|||ANCOVA|||||-1.09|-6.56|0.006
74046028|NCT04984876|147644624|OTHER||Odds Ratio (OR)|25.83||||0.002|TWO_SIDED|95.0|4.34|506.78|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||506.78|4.34|0.002
74046029|NCT04984876|147644624|OTHER||Odds Ratio (OR)|5.1||||0.073|TWO_SIDED|95.0|0.8|100.98|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||100.98|0.80|0.073
74046030|NCT04984876|147644625|OTHER||Odds Ratio (OR)|9.86||||0.018|TWO_SIDED|95.0|1.69|188.85|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||188.85|1.69|0.018
74046031|NCT04984876|147644625|OTHER||Odds Ratio (OR)|3.02||||0.164|TWO_SIDED|95.0|0.45|59.93|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||59.93|0.45|0.164
74046032|NCT04984876|147644626|OTHER||Odds Ratio (OR)|3.47||||0.138|TWO_SIDED|95.0|0.51|70.08|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||70.08|0.51|0.138
74046033|NCT04984876|147644626|OTHER||Odds Ratio (OR)|2.21||||0.247|TWO_SIDED|95.0|0.3|45.56|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||45.56|0.30|0.247
74046034|NCT04984876|147644627|OTHER||Odds Ratio (OR)|10.59|||<|0.001|TWO_SIDED|95.0|3.63|31.56|||proportional odds model||proportional odds model adjusting for treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), log transformed baseline total IgE at screening and region.|||31.56|3.63|<0.001
74046035|NCT04984876|147644627|OTHER||Odds Ratio (OR)|5.05||||0.001|TWO_SIDED|95.0|1.8|14.36|||proportional odds model||proportional odds model adjusting for treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), log transformed baseline total IgE at screening and region.|||14.36|1.80|0.001
74046036|NCT04984876|147644628|OTHER||Odds Ratio (OR)|4.73||||0.082|TWO_SIDED|95.0|0.74|93.16|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||93.16|0.74|0.082
74046037|NCT04984876|147644628|OTHER||Odds Ratio (OR)|0.61||||0.632|TWO_SIDED|95.0|0.02|16.43|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||16.43|0.02|0.632
74046038|NCT04984876|147644633|OTHER||LS Mean difference|-3.77|||<|0.001|TWO_SIDED|95.0|-5.15|-2.4|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-2.40|-5.15|<0.001
74046039|NCT04984876|147644633|OTHER||LS Mean difference|-4.93|||<|0.001|TWO_SIDED|95.0|-7.77|-2.09|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-2.09|-7.77|<0.001
74046040|NCT04984876|147644633|OTHER||LS Mean difference|-3.2||||0.015|TWO_SIDED|95.0|-6.08|-0.32|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-0.32|-6.08|0.015
74046041|NCT04984876|147644633|OTHER||LS Mean difference|-1.68||||0.13|TWO_SIDED|95.0|-4.62|1.25|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||1.25|-4.62|0.130
74046042|NCT04984876|147644634|OTHER||LS Mean difference|-0.33||||0.173|TWO_SIDED|95.0|-1.03|0.36|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.36|-1.03|0.173
74046043|NCT04984876|147644634|OTHER||LS Mean difference|-0.29||||0.202|TWO_SIDED|95.0|-0.96|0.39|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.39|-0.96|0.202
74046044|NCT04984876|147644634|OTHER||LS Mean difference|-0.37||||0.151|TWO_SIDED|95.0|-1.09|0.34|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.34|-1.09|0.151
74046045|NCT04984876|147644634|OTHER||LS Mean difference|-0.23||||0.264|TWO_SIDED|95.0|-0.94|0.49|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.49|-0.94|0.264
74046046|NCT04984876|147644634|OTHER||LS Mean difference|-0.43||||0.123|TWO_SIDED|95.0|-1.16|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.30|-1.16|0.123
74046047|NCT04984876|147644634|OTHER||LS Mean difference|-0.23||||0.258|TWO_SIDED|95.0|-0.94|0.47|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.47|-0.94|0.258
74046048|NCT04984876|147644634|OTHER||LS Mean difference|-0.17||||0.324|TWO_SIDED|95.0|-0.92|0.58|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.58|-0.92|0.324
74046049|NCT04984876|147644634|OTHER||LS Mean difference|-0.03||||0.473|TWO_SIDED|95.0|-0.78|0.73|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.73|-0.78|0.473
74046050|NCT04984876|147644635|OTHER||LS Mean difference|0.06||||0.597|TWO_SIDED|95.0|-0.44|0.57|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.57|-0.44|0.597
74046051|NCT04984876|147644635|OTHER||LS Mean difference|-0.39||||0.064|TWO_SIDED|95.0|-0.89|0.11|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.11|-0.89|0.064
74046052|NCT04984876|147644635|OTHER||LS Mean difference|-0.22||||0.191|TWO_SIDED|95.0|-0.72|0.28|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.28|-0.72|0.191
74046053|NCT04984876|147644635|OTHER||LS Mean difference|-0.02||||0.472|TWO_SIDED|95.0|-0.51|0.48|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.48|-0.51|0.472
74096100|NCT03118570|147741788|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.625||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.625
74096101|NCT03118570|147741789|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.615||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.615
74096102|NCT03118570|147741789|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.376||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.376
74096103|NCT03118570|147741789|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.259||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.259
74096104|NCT03118570|147741789|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.253||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.253
74096105|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.064||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.064
74096106|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.019||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.019
74096107|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.845||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.845
74096108|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.006
74096109|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.190
74096110|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.704||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.704
74096111|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.002||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.002
74096112|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.021||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.021
74096113|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.504||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.504
74096114|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.462||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.462
74096115|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.134||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.134
74096116|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.086
74096117|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.199||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.199
74096118|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.219||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 8||||0.219
74016984|NCT04418765|147585532|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|9.19|||<|0.0001|TWO_SIDED|95.0|4.16|24.35||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6b of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||24.35|4.16|<0.0001
74046054|NCT04984876|147644635|OTHER||LS Mean difference|0.03||||0.537|TWO_SIDED|95.0|-0.57|0.62|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.62|-0.57|0.537
74046055|NCT04984876|147644635|OTHER||LS Mean difference|-0.32||||0.141|TWO_SIDED|95.0|-0.91|0.27|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.27|-0.91|0.141
74046056|NCT04984876|147644635|OTHER||LS Meand difference|-0.45||||0.063|TWO_SIDED|95.0|-1.04|0.13|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.13|-1.04|0.063
74046057|NCT04984876|147644635|OTHER||LS Mean difference|-0.1||||0.368|TWO_SIDED|95.0|-0.68|0.48|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.48|-0.68|0.368
74046058|NCT04984876|147644636|OTHER||LS Mean difference|-0.24||||0.225|TWO_SIDED|95.0|-0.87|0.39|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.39|-0.87|0.225
74046059|NCT04984876|147644636|OTHER||LS Mean difference|-0.32||||0.153|TWO_SIDED|95.0|-0.93|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.30|-0.93|0.153
74046060|NCT04984876|147644636|OTHER||LS Mean difference|-0.3||||0.179|TWO_SIDED|95.0|-0.95|0.34|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.34|-0.95|0.179
74046061|NCT04984876|147644636|OTHER||LS Mean difference|0.11||||0.631|TWO_SIDED|95.0|-0.55|0.77|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.77|-0.55|0.631
74046062|NCT04984876|147644636|OTHER||LS Mean difference|-0.52||||0.06|TWO_SIDED|95.0|-1.18|0.14|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.14|-1.18|0.060
74046063|NCT04984876|147644636|OTHER||LS Mean difference|-0.08||||0.404|TWO_SIDED|95.0|-0.72|0.56|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.56|-0.72|0.404
74046064|NCT04984876|147644636|OTHER||LS Mean difference|-0.38||||0.135|TWO_SIDED|95.0|-1.06|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.30|-1.06|0.135
74046065|NCT04984876|147644636|OTHER||LS Mean difference|0.01||||0.514|TWO_SIDED|95.0|-0.7|0.72|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.72|-0.70|0.514
74046066|NCT04984876|147644637|OTHER||LS Mean difference|0.04||||0.574|TWO_SIDED|95.0|-0.42|0.51|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.51|-0.42|0.574
74046067|NCT04984876|147644637|OTHER||LS Mean difference|-0.37||||0.056|TWO_SIDED|95.0|-0.83|0.09|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.09|-0.83|0.056
74046068|NCT04984876|147644637|OTHER||LS Mean difference|-0.36||||0.069|TWO_SIDED|95.0|-0.83|0.12|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.12|-0.83|0.069
74046069|NCT04984876|147644637|OTHER||LS Mean difference|-0.19||||0.205|TWO_SIDED|95.0|-0.65|0.27|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.27|-0.65|0.205
74046070|NCT04984876|147644637|OTHER||LS Mean difference|-0.2||||0.248|TWO_SIDED|95.0|-0.76|0.37|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.37|-0.76|0.248
74046071|NCT04984876|147644637|OTHER||LS Mean difference|-0.42||||0.071|TWO_SIDED|95.0|-0.98|0.14|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.14|-0.98|0.071
74046072|NCT04984876|147644637|OTHER||LS Mean difference|-0.49||||0.048|TWO_SIDED|95.0|-1.06|0.09|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.09|-1.06|0.048
74046073|NCT04984876|147644637|OTHER||LS Mean difference|-0.3||||0.142|TWO_SIDED|95.0|-0.85|0.25|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.25|-0.85|0.142
74096119|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.112||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.112
74096120|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.086
74096121|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.245||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.245
74096122|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.232||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.232
74096123|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.237||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.237
74096124|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.088
74096125|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.302||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.302
74096126|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.626||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.626
74096127|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.517||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 8||||0.517
74096128|NCT03118570|147741790|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.262||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.262
74096129|NCT03118570|147741791|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||< 0.001
74096130|NCT03118570|147741791|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.004||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.004
74096131|NCT03118570|147741791|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.08||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.080
74096132|NCT03118570|147741791|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.031||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.031
74096133|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.06||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.060
74096134|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.015||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.015
74096135|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.795||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.795
74096136|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.011
74096137|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.047||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.047
74046074|NCT01726504|147644648|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||During the 8-week treatment period, the adjusted change from baseline in mean weekly CSBMs was 1.72 ± 0.12 (95% CI, 1.48 to 1.96) in the EA group and 0.82 ± 0.13 (95% CI, 0.58 to 1.07, P\<0.001) times more than that in the SA group.||||<0.001
74046075|NCT02436915|147644659|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of TUG (i.e., greater percent decrease of time to complete TUG from baseline to follow ups) as compared to the sham tDCS.||||||0.24|||||||ANOVA|||||||0.24
74046076|NCT02436915|147644660|EQUIVALENCE|We hypothesized that the real tDCS would improve the MoCA score (i.e., greater percent increase decrease of MoCA score from baseline to follow ups) as compared to the sham tDCS.||||||0.03|||||||ANOVA|||||||0.03
74046077|NCT02436915|147644661|EQUIVALENCE|We hypothesized that the real tDCS would improve the dual task performance of walking (i.e., greater percent decrease of dual task cost to walking speed from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA|||||||0.37
74046078|NCT02436915|147644662|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing sway speed from baseline to follow ups) as compared to the sham tDCS.||||||0.004|||||||ANOVA|||||||0.004
74046079|NCT02436915|147644663|EQUIVALENCE|We hypothesized that the real tDCS would reduce the depression (i.e., greater percent decrease of GDS score from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA|||||||0.37
74046080|NCT02436915|147644664|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of TMT (i.e., greater percent decrease of time to complete TMT from baseline to follow ups) as compared to the sham tDCS.||||||0.54|||||||ANOVA|||||||0.54
74046081|NCT02436915|147644665|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing postural sway area from baseline to follow ups) as compared to the sham tDCS.||||||0.0007|||||||ANOVA|||||||0.0007
74046082|NCT02436915|147644666|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of walking (i.e., greater percent decrease of dual task cost to stride time from baseline to follow ups) as compared to the sham tDCS.||||||0.04|||||||ANOVA|||||||0.04
74046083|NCT03531762|147644680|OTHER||Ratio of Geometric Least Square Mean|108.87|||||TWO_SIDED|90.0|101.2|117.13||||||||117.13|101.20|
74046084|NCT03531762|147644681|OTHER||Ratio of Geometric Least Square Mean|109.8|||||TWO_SIDED|90.0|101.69|118.55||||||||118.55|101.69|
74046085|NCT03531762|147644682|OTHER||Ratio of Geometric Least Square Mean|104.1|||||TWO_SIDED|90.0|92.93|116.61||||||||116.61|92.93|
74046086|NCT00364832|147644710|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.81|||||TWO_SIDED|90.0|0.73|0.9|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ week (0.4, 0.8 and 1.2 dose group)||0.90|0.73|
74046087|NCT00364832|147644710|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.72|||||TWO_SIDED|90.0|0.55|0.86|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 3 weeks (0.4, 0.8 and 1.2 dose group)||0.86|0.55|
74046088|NCT00364832|147644710|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.93|||||TWO_SIDED|90.0|0.81|1.09|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 4 weeks (0.4, 0.8 and 1.2 dose group)||1.09|0.81|
74046089|NCT04222673|147644726|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
74046090|NCT04222673|147644727|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
74046091|NCT04222673|147644728|OTHER|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
74046092|NCT04222673|147644729|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
74046093|NCT04222673|147644730|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
74046094|NCT04222673|147644731|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
74046095|NCT04222673|147644732|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
74046096|NCT04222673|147644733|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
74046097|NCT00068822|147644734|SUPERIORITY_OR_OTHER||Adjusted treatment effect|0.7||||0.49|TWO_SIDED|95.0|-1.3|2.8|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.||2.8|-1.3|0.49
74046098|NCT00068822|147644735|SUPERIORITY_OR_OTHER||Treatment Effect|1.0||||0.45|TWO_SIDED|95.0|-1.7|3.7|||ANCOVA|||SF-36 Physical Component Summary treatment effect||3.7|-1.7|0.45
74046099|NCT00068822|147644735|SUPERIORITY_OR_OTHER||Treatment Effect|1.0||||0.83|TWO_SIDED|95.0|-3.7|4.6|||ANCOVA|||SF-36 Mental Component Summary treatment effect||4.6|-3.7|0.83
74046100|NCT00068822|147644735|SUPERIORITY_OR_OTHER||Treatment Effect|0.2||||0.33|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain Frequency Index treatment effect||0.6|-0.2|0.33
74046101|NCT00068822|147644735|SUPERIORITY_OR_OTHER||Treatment Effect|0.33||||0.33|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain Bothersome Index treatment effect||0.6|-0.2|0.33
74046102|NCT00068822|147644735|SUPERIORITY_OR_OTHER||Treatment Effect|0.05||||0.13|TWO_SIDED|95.0|-0.01|0.11|||ANCOVA|||EQ-5D Index treatment effect||0.11|-0.01|0.13
74046103|NCT00068822|147644735|SUPERIORITY_OR_OTHER||Treatment Effect|0.4||||0.5|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||SOF-ADL treatment effect||1.6|-0.8|0.5
74046104|NCT00068822|147644736|SUPERIORITY_OR_OTHER||Adjusted treatment effect|0.7||||0.19|TWO_SIDED|95.0|-0.3|1.7|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.||1.7|-0.3|0.19
74046105|NCT00617162|147644742|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.3989|TWO_SIDED|95.0|-5.5|2.2|||Fisher Exact|||||2.2|-5.5|0.3989
74046106|NCT00735072|147644751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there will be no difference in the week 24 change in %activated CD8+ T cells between arms. Assuming a standard deviation as high as 3.5% and a Type I error of 5%, with 21 subjects in each treatment arm we would have 80% statistical power to detect a mean 3 percentage-point difference in the percent of activated CD8+ T cells between the active drug and placebo groups.||||0.014
74046107|NCT00735072|147644752|OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
74046108|NCT00735072|147644753|OTHER|||||||0.33|||||||Mixed Models Analysis|||||||0.33
74046109|NCT03146403|147644756|SUPERIORITY|||||||0.7474|||||||Wilcoxon (Mann-Whitney)|||||||0.7474
74046110|NCT03146403|147644757|SUPERIORITY|||||||0.645|||||||Wilcoxon (Mann-Whitney)|||||||0.6450
74046111|NCT03146403|147644758|SUPERIORITY|||||||0.3157|||||||Chi-squared|||||||0.3157
74046112|NCT03146403|147644759|SUPERIORITY|||||||0.3869|||||||Log Rank|||||||0.3869
74046113|NCT03146403|147644760|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.2200
74046114|NCT01024920|147644761|OTHER|||||||0.8531||||||P-value for comparison of Kaplan-Meier estimates at 9 months using normal approximation test (two-sided).|Normal approximation test|||||||0.8531
74016985|NCT04418765|147585533|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-6.7|-4.2||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 5c of testing order.|Mixed Models Analysis|||"Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/\>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||-4.2|-6.7|<0.0001
74046115|NCT01024920|147644763|OTHER||Hazard Ratio (HR)|1.12||||0.6395|TWO_SIDED|95.0|0.697|1.8|||Log Rank||Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery.|A stratified log-rank test (two-sided, 0.05 significance level) was used to test the effect of nintedanib on PFS compared with sunitinib. The test was stratified by Motzer risk score category (low/intermediate or high) and prior nephrectomy surgery for Renal Cell Cancer (yes or no).||1.800|0.697|0.6395
74046116|NCT01024920|147644764|OTHER||Odds Ratio (OR)|0.484||||0.1213|TWO_SIDED|95.0|0.193|1.212|||Regression, Logistic||Odds ratio \> 1 favours nintedanib.|A logistic regression model stratified by Motzer risk score category and prior surgery for renal cell cancer (RCC) was used to compare the objective response rate between the two treatment arms. The corresponding odds ratio and 95% Confidence Intervals was also presented.||1.212|0.193|0.1213
74046117|NCT01024920|147644766|OTHER||Hazard Ratio (HR)|0.92||||0.7593|TWO_SIDED|95.0|0.542|1.564||P-value from log-rank stratified by Motzer risk score and previous surgery.|Log Rank||Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.564|0.542|0.7593
74016986|NCT04418765|147585533|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-5.0|-2.5||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6c of testing order.|Mixed Models Analysis|||"Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/\>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||-2.5|-5.0|<0.0001
74016987|NCT01077973|147585594|SUPERIORITY_OR_OTHER||Least-square (LS) mean difference|-1.12||||0.299|TWO_SIDED|95.0|-3.23|1.0||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.00|-3.23|0.299
74046118|NCT01024920|147644767|OTHER||Cox Proportional Hazard|1.143||||0.5958|TWO_SIDED|95.0|0.697|1.873|||Log Rank|P-value from log-rank stratified by Motzer risk score and previous surgery.|Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.873|0.697|0.5958
74046119|NCT01024920|147644768|OTHER||Hazard Ratio (HR)|1.142||||0.5712|TWO_SIDED|95.0|0.72|1.812|||Log Rank|P-value from log-rank stratified by Motzer risk score and previous surgery (two-sided).|Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.812|0.720|0.5712
74096138|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.756||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.756
74046120|NCT00926185|147644814|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.06||||0.9381|TWO_SIDED|95.0|-0.26|0.39|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.39|-0.26|0.9381
74046121|NCT00926185|147644814|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.2||||0.3585|TWO_SIDED|95.0|-0.13|0.53|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.53|-0.13|0.3585
74046122|NCT00926185|147644814|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.27||||0.1375|TWO_SIDED|95.0|-0.06|0.6|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.60|-0.06|0.1375
74096139|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.006
74096140|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.137||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.137
74096141|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.639||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.639
74096142|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.325||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.325
74096143|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.108||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.108
74096144|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.078||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.078
74096145|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.106||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.106
74096146|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.236||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.236
74096147|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.164||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.164
74096148|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.031||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.031
74096149|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.224||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.224
74096150|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.291||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.291
74096151|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.324||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.324
74096152|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.188||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.188
74096153|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.503||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.503
74096154|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.385||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.385
74096155|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.727||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.727
74096156|NCT03118570|147741792|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.338||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.338
74096157|NCT03118570|147741793|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||< 0.001
74096158|NCT03118570|147741793|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||< 0.001
74096159|NCT03118570|147741793|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||< 0.001
74096160|NCT03118570|147741793|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||< 0.001
74096161|NCT03118570|147741795|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
74096162|NCT03118570|147741795|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
74096163|NCT03118570|147741795|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.08||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.080
74096164|NCT03118570|147741795|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.238||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.238
74096165|NCT03118570|147741795|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.238||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.238
74096166|NCT03118570|147741795|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.035||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.035
74096167|NCT03118570|147741795|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.687||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.687
74096168|NCT03118570|147741795|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.107||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.107
74096169|NCT03118570|147741795|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.128||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.128
74096170|NCT03118570|147741796|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
74096171|NCT03118570|147741796|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
74096172|NCT03118570|147741796|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.088
74096173|NCT03118570|147741796|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.184||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.184
74096174|NCT03118570|147741796|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.144||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.144
74096175|NCT03118570|147741796|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.028||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.028
74096176|NCT03118570|147741796|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.694||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.694
74096177|NCT03118570|147741796|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.143||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.143
74096178|NCT03118570|147741796|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.111||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.111
74096179|NCT03118570|147741797|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
74096180|NCT03118570|147741797|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
73880531|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.9||||0.17|TWO_SIDED|95.0|0.76|4.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.78|0.76|0.1700
73880532|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.47||||0.0153|TWO_SIDED|95.0|1.27|9.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.51|1.27|0.0153
74046123|NCT04599972|147644816|SUPERIORITY||Odds Ratio (OR)|2.979|||<|0.01|TWO_SIDED|95.0|1.753|5.064|||Regression, Logistic|||All treatment comparisons for primary and secondary endpoints related to BDCVA were conducted with a logistic regression model including fixed effects of baseline BDCVA at 40 cm as a covariate and treatment.||5.064|1.753|<0.01
74046124|NCT04599972|147644817|SUPERIORITY||Odds Ratio (OR)|2.807|||<|0.01|TWO_SIDED|95.0|1.655|4.762|||Regression, Logistic|||||4.762|1.655|<0.01
74046125|NCT04599972|147644818|SUPERIORITY||Odds Ratio (OR)|6.002|||<|0.01|TWO_SIDED|95.0|3.431|10.499|||Regression, Logistic|||||10.499|3.431|<0.01
74046126|NCT04599972|147644819|SUPERIORITY||Odds Ratio (OR)|4.161|||<|0.01|TWO_SIDED|95.0|2.404|7.204|||Regression, Logistic|||||7.204|2.404|<0.01
74046127|NCT03949621|147644820|OTHER|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9632|||||TWO_SIDED|90.0|0.7938|1.1688||||||||1.1688|0.7938|
74046128|NCT03949621|147644821|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9606|||||TWO_SIDED|90.0|0.798|1.1562||||||||1.1562|0.798|
74046129|NCT03949621|147644822|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0162|||||TWO_SIDED|90.0|0.9001|1.1473||||||||1.1473|0.9001|
74046130|NCT00605358|147644823|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.018|TWO_SIDED|95.0|1.17|4.93|||Chi-squared|||Participants in the Open Door Intervention and the Services Referral condition were compared on rates of engagement in mental health services over the study follow-up period.||4.93|1.17|.018
74046131|NCT02861118|147644824|OTHER|||||||0.024|||||||Regression, Logistic|||IBD||||0.024
74046132|NCT02861118|147644824|OTHER|||||||0.006|||||||Regression, Logistic|||Corticosteroids||||0.006
74046133|NCT02861118|147644824|OTHER|||||||0.006|||||||Regression, Logistic|||Chronic Obstructive Pulmonary Disease||||0.006
74046134|NCT02861118|147644825|OTHER|||||||0.044|||||||Regression, Logistic|||IBD||||0.044
74046135|NCT02861118|147644825|OTHER|||||||0.003|||||||Regression, Logistic|||Corticosteroids||||0.003
74046136|NCT02861118|147644825|OTHER|||||||0.003|||||||Regression, Logistic|||Myocardial Infarction||||0.003
74046137|NCT02861118|147644826|OTHER|||||||0.007|||||||Regression, Logistic|||Corticosteroids||||0.007
74046138|NCT02861118|147644827|OTHER|||||||0.002|||||||Regression, Logistic|||Corticosteroids||||0.002
74046139|NCT02861118|147644827|OTHER|||||||0.003|||||||Regression, Logistic|||Skin Disease||||0.003
74046140|NCT01594411|147644831|SUPERIORITY_OR_OTHER||||||<|0.001|||||||one-sided binomial with alpha level of 0|||"The proportion of patients whose final treatment plan changes from the preliminary will be estimated, and a one-sided binomial test with alpha level of .05 will be used to test whether it is greater than 10%.~This is the level at which it is assumed that patient management has been modified by a practically important amount."||||<0.001
74046141|NCT00565812|147644878|SUPERIORITY_OR_OTHER||Difference in Slopes|0.012|STANDARD_ERROR_OF_MEAN|0.018||0.50877|TWO_SIDED|95.0|-0.023|0.046|||Mixed Models Analysis|||Slopes, 95 percent confidence interval (CI), P-values: Random coefficients mixed-effects model for repeated measures (MMRM) with random intercept and slope for each participant,fixed effects for treatment group,time (years),treatment group\*time interaction,(collapsed)Kellgren and Lawrence Grades (KLG), KLG\*time interaction,geographic region,gender,age,body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha =0.0499.||0.046|-0.023|0.508770
74046142|NCT00565812|147644878|SUPERIORITY_OR_OTHER||Difference in Slopes|0.005|STANDARD_ERROR_OF_MEAN|0.017||0.754074|TWO_SIDED|95.0|-0.029|0.04|||Mixed Models Analysis|||Slopes, 95 percent CI, P-values: MMRM with random intercept and slope for each participant, fixed effects for treatment group, time (years), treatment group\*time interaction, (collapsed) KLG, KLG\*time interaction, geographic region, gender, age, body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha=0.0499.||0.040|-0.029|0.754074
74046143|NCT00565812|147644879|SUPERIORITY_OR_OTHER||Difference in slopes|0.023|STANDARD_ERROR_OF_MEAN|0.023||0.312|TWO_SIDED|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.067|-0.022|0.312
74046144|NCT00565812|147644879|SUPERIORITY_OR_OTHER||Difference in slopes|0.022|STANDARD_ERROR_OF_MEAN|0.023||0.327|TWO_SIDED|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.067|-0.022|0.327
74046145|NCT00565812|147644880|SUPERIORITY_OR_OTHER||Difference in slopes|0.004|STANDARD_ERROR_OF_MEAN|0.026||0.881|TWO_SIDED|95.0|-0.046|0.054|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.054|-0.046|0.881
74016988|NCT01077973|147585595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.193|TWO_SIDED|95.0|0.52|1.14||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.14|0.52|0.193
74016989|NCT01077973|147585596|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.304|TWO_SIDED|95.0|0.5|1.24||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.24|0.50|0.304
74096181|NCT03118570|147741797|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.026||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.026
74016990|NCT01077973|147585596|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.936|TWO_SIDED|95.0|0.65|1.59||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.59|0.65|0.936
74016991|NCT01077973|147585597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.072|TWO_SIDED|95.0|0.41|1.04||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.04|0.41|0.072
74016992|NCT01077973|147585597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.652|TWO_SIDED|95.0|0.58|1.41||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.41|0.58|0.652
74016993|NCT01077973|147585597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.108|TWO_SIDED|95.0|0.49|1.07||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.07|0.49|0.108
74016994|NCT01077973|147585598|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.402|TWO_SIDED|95.0|-0.65|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.65|0.402
74016995|NCT01077973|147585598|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.407|TWO_SIDED|95.0|-0.64|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.64|0.407
74016996|NCT01077973|147585598|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.991|TWO_SIDED|95.0|-0.38|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.38|0.991
74016997|NCT01077973|147585598|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.313|TWO_SIDED|95.0|-0.75|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.24|-0.75|0.313
74016998|NCT01077973|147585598|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.621|TWO_SIDED|95.0|-0.62|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.62|0.621
74016999|NCT01077973|147585598|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.533|TWO_SIDED|95.0|-0.54|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.28|-0.54|0.533
74017000|NCT01077973|147585598|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.352|TWO_SIDED|95.0|-0.79|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.28|-0.79|0.352
74096182|NCT03118570|147741797|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.007||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.007
73888064|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.3||||0.0354|TWO_SIDED|95.0|-87.5|-3.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.1|-87.5|0.0354
74096183|NCT03118570|147741797|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.004||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.004
74096184|NCT03118570|147741797|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.085||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.085
74096185|NCT03118570|147741797|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.04||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.040
74096186|NCT03118570|147741797|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.061||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.061
73880533|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|6.04||||0.0009|TWO_SIDED|95.0|2.08|17.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||17.53|2.08|0.0009
74017001|NCT01077973|147585598|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.573|TWO_SIDED|95.0|-0.69|0.38||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.38|-0.69|0.573
74017002|NCT01077973|147585598|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.657|TWO_SIDED|95.0|-0.54|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-0.54|0.657
74017003|NCT01077973|147585599|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.382|TWO_SIDED|95.0|-0.36|0.14||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.36|0.382
74017004|NCT01077973|147585599|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.242|TWO_SIDED|95.0|-0.39|0.1||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.10|-0.39|0.242
74017005|NCT01077973|147585599|SUPERIORITY_OR_OTHER||LS mean difference|0.04||||0.72|TWO_SIDED|95.0|-0.17|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.24|-0.17|0.720
74017006|NCT01077973|147585599|SUPERIORITY_OR_OTHER||LS mean difference|-0.16||||0.235|TWO_SIDED|95.0|-0.43|0.11||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.11|-0.43|0.235
74017007|NCT01077973|147585599|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.63|TWO_SIDED|95.0|-0.34|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.20|-0.34|0.630
74096187|NCT03118570|147741797|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.189||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.189
74096188|NCT03118570|147741798|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
74096189|NCT03118570|147741798|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
74096190|NCT03118570|147741798|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.035||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.035
74096191|NCT03118570|147741798|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.003
74096192|NCT03118570|147741798|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.003
74017008|NCT01077973|147585599|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.393|TWO_SIDED|95.0|-0.32|0.13||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.32|0.393
74017009|NCT01077973|147585599|SUPERIORITY_OR_OTHER||LS mean difference|-0.14||||0.382|TWO_SIDED|95.0|-0.46|0.18||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.18|-0.46|0.382
74017010|NCT01077973|147585599|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.995|TWO_SIDED|95.0|-0.32|0.32||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.32|-0.32|0.995
74017011|NCT01077973|147585599|SUPERIORITY_OR_OTHER||LS mean difference|-0.14||||0.287|TWO_SIDED|95.0|-0.41|0.12||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.12|-0.41|0.287
74017012|NCT01077973|147585600|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.377|TWO_SIDED|95.0|-0.98|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.98|0.377
74017013|NCT01077973|147585600|SUPERIORITY_OR_OTHER||LS mean difference|-0.34||||0.324|TWO_SIDED|95.0|-1.01|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-1.01|0.324
74017014|NCT01077973|147585600|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.902|TWO_SIDED|95.0|-0.52|0.59||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.52|0.902
74017015|NCT01077973|147585600|SUPERIORITY_OR_OTHER||LS mean difference|-0.42||||0.273|TWO_SIDED|95.0|-1.17|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-1.17|0.273
74017016|NCT01077973|147585600|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.616|TWO_SIDED|95.0|-0.94|0.56||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.56|-0.94|0.616
74017017|NCT01077973|147585600|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.471|TWO_SIDED|95.0|-0.85|0.39||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.39|-0.85|0.471
74017018|NCT01077973|147585600|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.356|TWO_SIDED|95.0|-1.24|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|-1.24|0.356
74017019|NCT01077973|147585600|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.722|TWO_SIDED|95.0|-1.0|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|-1.00|0.722
74017020|NCT01077973|147585600|SUPERIORITY_OR_OTHER||LS mean difference|-0.24||||0.493|TWO_SIDED|95.0|-0.94|0.46||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|-0.94|0.493
74017021|NCT01077973|147585601|SUPERIORITY_OR_OTHER||LS mean difference|-0.27||||0.259|TWO_SIDED|95.0|-0.75|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.20|-0.75|0.259
74017022|NCT01077973|147585601|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.378|TWO_SIDED|95.0|-0.69|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.69|0.378
74017023|NCT01077973|147585601|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.762|TWO_SIDED|95.0|-0.45|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-0.45|0.762
74017024|NCT01077973|147585601|SUPERIORITY_OR_OTHER||LS mean difference|-0.42||||0.281|TWO_SIDED|95.0|-1.17|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-1.17|0.281
74017025|NCT01077973|147585601|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.582|TWO_SIDED|95.0|-0.97|0.55||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.55|-0.97|0.582
74017026|NCT01077973|147585601|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.523|TWO_SIDED|95.0|-0.83|0.42||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.42|-0.83|0.523
74017027|NCT01077973|147585602|SUPERIORITY_OR_OTHER||LS mean difference|-0.45||||0.327|TWO_SIDED|95.0|-1.35|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|-1.35|0.327
74017028|NCT01077973|147585602|SUPERIORITY_OR_OTHER||LS mean difference|-0.32||||0.489|TWO_SIDED|95.0|-1.21|0.58||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.58|-1.21|0.489
74017029|NCT01077973|147585602|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.726|TWO_SIDED|95.0|-0.88|0.61||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.61|-0.88|0.726
74017030|NCT01077973|147585602|SUPERIORITY_OR_OTHER||LS mean difference|-0.7||||0.32|TWO_SIDED|95.0|-2.09|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|-2.09|0.320
74046146|NCT00565812|147644880|SUPERIORITY_OR_OTHER||Difference in slopes|-0.007|STANDARD_ERROR_OF_MEAN|0.025||0.78|TWO_SIDED|95.0|-0.056|0.042|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.042|-0.056|0.780
74046147|NCT00565812|147644881|SUPERIORITY_OR_OTHER||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.84||0.639|TWO_SIDED|95.0|-1.26|2.05|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.05|-1.26|0.639
74046148|NCT00565812|147644881|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.84||0.957|TWO_SIDED|95.0|-1.61|1.7|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.70|-1.61|0.957
74046149|NCT00565812|147644881|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.96||0.893|TWO_SIDED|95.0|-1.76|2.01|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.01|-1.76|0.893
74046150|NCT00565812|147644881|SUPERIORITY_OR_OTHER||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|0.96||0.365|TWO_SIDED|95.0|-1.01|2.76|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.76|-1.01|0.365
74046151|NCT00565812|147644881|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|1.05||0.678|TWO_SIDED|95.0|-1.63|2.51|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.51|-1.63|0.678
74096193|NCT03118570|147741798|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.088
74017031|NCT01077973|147585602|SUPERIORITY_OR_OTHER||LS mean difference|-0.47||||0.506|TWO_SIDED|95.0|-1.86|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.86|0.506
74017032|NCT01077973|147585602|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.691|TWO_SIDED|95.0|-1.38|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.38|0.691
74017033|NCT01077973|147585603|SUPERIORITY_OR_OTHER||LS mean difference|-0.72||||0.292|TWO_SIDED|95.0|-2.07|0.62||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.62|-2.07|0.292
74017034|NCT01077973|147585603|SUPERIORITY_OR_OTHER||LS mean difference|-0.53||||0.439|TWO_SIDED|95.0|-1.87|0.82||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-1.87|0.439
74017035|NCT01077973|147585603|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.733|TWO_SIDED|95.0|-1.31|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.31|0.733
74017036|NCT01077973|147585603|SUPERIORITY_OR_OTHER||LS mean difference|-0.68||||0.526|TWO_SIDED|95.0|-2.8|1.43||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.43|-2.80|0.526
74017037|NCT01077973|147585603|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.624|TWO_SIDED|95.0|-2.19|1.31||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.31|-2.19|0.624
74017038|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|3.02||||0.672|TWO_SIDED|95.0|-11.03|17.07||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||17.07|-11.03|0.672
74017039|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|-4.47||||0.467|TWO_SIDED|95.0|-17.61|8.68||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.68|-17.61|0.467
74017040|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|7.55||||0.164|TWO_SIDED|95.0|-2.96|18.05||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.05|-2.96|0.164
74017041|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|-7.52||||0.427|TWO_SIDED|95.0|-25.96|10.92||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.92|-25.96|0.427
74017042|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|-5.66||||0.537|TWO_SIDED|95.0|-23.57|12.25||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.25|-23.57|0.537
74017043|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|-1.83||||0.813|TWO_SIDED|95.0|-16.88|13.22||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.22|-16.88|0.813
74096194|NCT03118570|147741798|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.016||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.016
74017044|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|-5.5||||0.455|TWO_SIDED|95.0|-19.24|8.24||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.24|-19.24|0.455
74017045|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|-4.02||||0.57|TWO_SIDED|95.0|-17.63|9.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.59|-17.63|0.570
74017046|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.792|TWO_SIDED|95.0|-13.8|10.5||p-value was calculated using CMH test which was adjusted which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.50|-13.80|0.792
74017047|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
74046152|NCT00565812|147644881|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|1.05||0.902|TWO_SIDED|95.0|-2.18|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.93|-2.18|0.902
74046153|NCT00565812|147644881|SUPERIORITY_OR_OTHER||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|1.15||0.577|TWO_SIDED|95.0|-2.89|1.61|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-2.89|0.577
74046154|NCT00565812|147644881|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|1.14||0.98|TWO_SIDED|95.0|-2.26|2.21|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.21|-2.26|0.980
74046155|NCT00565812|147644881|SUPERIORITY_OR_OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.17||0.95|TWO_SIDED|95.0|-2.37|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.23|-2.37|0.950
74046156|NCT00565812|147644881|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|1.17||0.292|TWO_SIDED|95.0|-3.53|1.06|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.06|-3.53|0.292
74046157|NCT00565812|147644882|SUPERIORITY_OR_OTHER||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.683|TWO_SIDED|95.0|-0.3|0.46|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.46|-0.30|0.683
74046158|NCT00565812|147644882|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.19||0.853|TWO_SIDED|95.0|-0.42|0.35|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.35|-0.42|0.853
74017048|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
74046159|NCT00565812|147644882|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.22||0.938|TWO_SIDED|95.0|-0.41|0.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.44|-0.41|0.938
74046160|NCT00565812|147644882|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.648|TWO_SIDED|95.0|-0.32|0.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.52|-0.32|0.648
74096195|NCT03118570|147741798|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.068||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.068
74017049|NCT01077973|147585604|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
74017050|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|6.06||||0.48|TWO_SIDED|95.0|-10.86|22.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.99|-10.86|0.480
74017051|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|4.34||||0.612|TWO_SIDED|95.0|-12.55|21.23||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.23|-12.55|0.612
74017052|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|1.47||||0.839|TWO_SIDED|95.0|-12.6|15.55||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.55|-12.60|0.839
74017053|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|-13.2||||0.13|TWO_SIDED|95.0|-29.4|2.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.99|-29.40|0.130
74017054|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|-7.83||||0.331|TWO_SIDED|95.0|-23.39|7.73||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.73|-23.39|0.331
74017055|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|-5.5||||0.45|TWO_SIDED|95.0|-19.59|8.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.59|-19.59|0.450
74017056|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
74017057|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
74017058|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
74017059|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
74017060|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
74096196|NCT03118570|147741798|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.16||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.160
74096197|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.065||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.065
74017061|NCT01077973|147585605|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
74046161|NCT00565812|147644882|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.24||0.916|TWO_SIDED|95.0|-0.49|0.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.44|-0.49|0.916
74046162|NCT00565812|147644882|SUPERIORITY_OR_OTHER||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.528|TWO_SIDED|95.0|-0.6|0.31|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.31|-0.60|0.528
74046163|NCT00565812|147644882|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.365|TWO_SIDED|95.0|-0.73|0.27|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.27|-0.73|0.365
74046164|NCT00565812|147644882|SUPERIORITY_OR_OTHER||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.25||0.328|TWO_SIDED|95.0|-0.74|0.25|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.25|-0.74|0.328
74046165|NCT00565812|147644882|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.26||0.54|TWO_SIDED|95.0|-0.66|0.35|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.35|-0.66|0.540
74046166|NCT00565812|147644882|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.26||0.423|TWO_SIDED|95.0|-0.71|0.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.30|-0.71|0.423
73880534|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6228|TWO_SIDED|95.0|0.5|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.23|0.50|0.6228
74017062|NCT01077973|147585608|SUPERIORITY_OR_OTHER||Difference in proportion|3.89||||0.355|TWO_SIDED|95.0|-3.33|11.1||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.10|-3.33|0.355
74017063|NCT01077973|147585608|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.623|TWO_SIDED|95.0|-6.62|4.2||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.20|-6.62|0.623
74017064|NCT01077973|147585608|SUPERIORITY_OR_OTHER||Difference in proportion|5.1||||0.094|TWO_SIDED|95.0|-0.9|11.11||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.11|-0.90|0.094
74017065|NCT01077973|147585608|SUPERIORITY_OR_OTHER||Difference in proportion|4.43||||0.565|TWO_SIDED|95.0|-10.43|19.29||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.29|-10.43|0.565
74046167|NCT00565812|147644883|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.904|TWO_SIDED|95.0|-0.17|0.2|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.20|-0.17|0.904
74046168|NCT00565812|147644883|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.582|TWO_SIDED|95.0|-0.24|0.13|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.13|-0.24|0.582
74096198|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.405||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.405
74017066|NCT01077973|147585608|SUPERIORITY_OR_OTHER||Difference in proportion|-2.09||||0.765|TWO_SIDED|95.0|-16.15|11.97||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.97|-16.15|0.765
74017067|NCT01077973|147585608|SUPERIORITY_OR_OTHER||Difference in proportion|6.47||||0.288|TWO_SIDED|95.0|-5.43|18.37||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.37|-5.43|0.288
74096199|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.966||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.966
74096200|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.003
74096201|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.229||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.229
74096202|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.807||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.807
74096203|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.042||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.042
74096204|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.283||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.283
74017068|NCT01077973|147585608|SUPERIORITY_OR_OTHER||Difference in proportion|-0.87||||0.928|TWO_SIDED|95.0|-20.0|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.27|-20.00|0.928
74017069|NCT01077973|147585608|SUPERIORITY_OR_OTHER||Difference in proportion|-6.4||||0.495|TWO_SIDED|95.0|-25.14|12.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.33|-25.14|0.495
74096205|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.536||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.536
74096206|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.765||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.765
74096207|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.247||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.247
74096208|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.050
74096209|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.037
74096210|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.174||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.174
74096211|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.558||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.558
74096212|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.02||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.020
74096213|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.346||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.346
74096214|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.387||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.387
74017070|NCT01077973|147585608|SUPERIORITY_OR_OTHER||Difference in proportion|5.46||||0.477|TWO_SIDED|95.0|-9.66|20.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.59|-9.66|0.477
74046169|NCT00565812|147644883|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.818|TWO_SIDED|95.0|-0.22|0.18|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.18|-0.22|0.818
74046170|NCT00565812|147644883|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.988|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG x visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.20|-0.20|0.988
74046171|NCT00565812|147644883|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.11||0.857|TWO_SIDED|95.0|-0.2|0.24|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.24|-0.20|0.857
74046172|NCT00565812|147644883|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.658|TWO_SIDED|95.0|-0.17|0.27|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.27|-0.17|0.658
74046173|NCT00565812|147644883|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.612|TWO_SIDED|95.0|-0.28|0.17|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.17|-0.28|0.612
74046174|NCT00565812|147644883|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.391|TWO_SIDED|95.0|-0.32|0.13|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.13|-0.32|0.391
74046175|NCT00565812|147644883|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||1|TWO_SIDED|95.0|-0.24|0.24|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.24|-0.24|1.000
74046176|NCT00565812|147644883|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.086|TWO_SIDED|95.0|-0.45|0.03|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.03|-0.45|0.086
74096215|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.093||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.093
74096216|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.156||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.156
74096217|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.324||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.324
74017071|NCT03889639|147585636|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95 percentage (%) confidence interval (CI) were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-56.16||||0.1673|TWO_SIDED|95.0|-193.99|17.05|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||17.05|-193.99|0.1673
74046177|NCT00565812|147644884|SUPERIORITY_OR_OTHER||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.62||0.586|TWO_SIDED|95.0|-0.88|1.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.55|-0.88|0.586
74017072|NCT03889639|147585636|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-62.8||||0.354|TWO_SIDED|95.0|-356.24|41.91|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||41.91|-356.24|0.3540
74017073|NCT03889639|147585636|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|13.49||||0.7674|TWO_SIDED|95.0|-126.05|66.89|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||66.89|-126.05|0.7674
74017074|NCT03889639|147585636|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|85.02||||0.0178|TWO_SIDED|95.0|28.02|96.88|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||96.88|28.02|0.0178
74017075|NCT03889639|147585637|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|10.17||||0.7736|TWO_SIDED|95.0|-86.49|56.73|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||56.73|-86.49|0.7736
74017076|NCT03889639|147585637|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|37.07||||0.248|TWO_SIDED|95.0|-38.08|71.32|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||71.32|-38.08|0.2480
74017077|NCT03889639|147585637|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|38.5||||0.3081|TWO_SIDED|95.0|-56.61|75.85|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||75.85|-56.61|0.3081
74017078|NCT03889639|147585637|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|89.34||||0.0001|TWO_SIDED|95.0|68.39|96.41|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||96.41|68.39|0.0001
74017079|NCT03889639|147585638|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-62.16||||0.1525|TWO_SIDED|95.0|-214.44|16.38|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||16.38|-214.44|0.1525
74046178|NCT00565812|147644884|SUPERIORITY_OR_OTHER||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.62||0.789|TWO_SIDED|95.0|-1.05|1.38|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.38|-1.05|0.789
74046179|NCT00565812|147644884|SUPERIORITY_OR_OTHER||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.69||0.821|TWO_SIDED|95.0|-1.21|1.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.52|-1.21|0.821
74096218|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.92||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.920
74096219|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.04||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.040
74096220|NCT03118570|147741799|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.643||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.643
74017080|NCT03889639|147585638|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-47.38||||0.4606|TWO_SIDED|95.0|-312.91|47.4|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||47.40|-312.91|0.4606
74017081|NCT03889639|147585638|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|2.9||||0.949|TWO_SIDED|95.0|-138.96|60.54|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||60.54|-138.96|0.9490
74017082|NCT03889639|147585638|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|65.05||||0.2324|TWO_SIDED|95.0|-96.21|93.77|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||93.77|-96.21|0.2324
74017083|NCT01703858|147585642|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.68|STANDARD_DEVIATION|10.0||0|TWO_SIDED|90.0|92.501|105.272|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||105.272|92.501|0.0000
74017084|NCT01703858|147585642|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.16|STANDARD_DEVIATION|18.3||0.9644|TWO_SIDED|90.0|62.331|78.962|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||78.962|62.331|0.9644
74017085|NCT01703858|147585642|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.36|STANDARD_DEVIATION|18.8||0.2835|TWO_SIDED|90.0|73.648|94.346|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||94.346|73.648|0.2835
74017086|NCT01703858|147585642|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.18|STANDARD_DEVIATION|16.7||0.1599|TWO_SIDED|90.0|104.923|130.867|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||130.867|104.923|0.1599
74017087|NCT01703858|147585642|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.4|STANDARD_DEVIATION|15.8||0.002|TWO_SIDED|90.0|88.072|107.719|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||107.719|88.072|0.0020
74046180|NCT00565812|147644884|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.69||0.294|TWO_SIDED|95.0|-0.63|2.09|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.09|-0.63|0.294
74046181|NCT00565812|147644884|SUPERIORITY_OR_OTHER||LS mean difference|0.48|STANDARD_ERROR_OF_MEAN|0.76||0.532|TWO_SIDED|95.0|-1.02|1.97|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.97|-1.02|0.532
74046182|NCT00565812|147644884|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.76||0.938|TWO_SIDED|95.0|-1.55|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.43|-1.55|0.938
74017088|NCT01703858|147585643|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|89.26|STANDARD_DEVIATION|25.3||0.1261|TWO_SIDED|90.0|75.893|104.973|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||104.973|75.893|0.1261
74017089|NCT01703858|147585643|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|54.57|STANDARD_DEVIATION|47.4||0.9808|TWO_SIDED|90.0|40.711|73.157|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||73.157|40.711|0.9808
74017090|NCT01703858|147585643|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|94.88|STANDARD_DEVIATION|43.2||0.1449|TWO_SIDED|90.0|72.175|124.731|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||124.731|72.175|0.1449
74017091|NCT01703858|147585643|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|169.46|STANDARD_DEVIATION|49.7||0.9463|TWO_SIDED|90.0|124.093|231.419|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||231.419|124.093|0.9463
74017092|NCT01703858|147585643|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|81.06|STANDARD_DEVIATION|33.3||0.4564|TWO_SIDED|90.0|65.811|99.848|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||99.848|65.811|0.4564
74017093|NCT01703858|147585644|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.66|STANDARD_DEVIATION|9.9||0|TWO_SIDED|90.0|92.5|105.225|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||105.225|92.500|0.0000
74017094|NCT01703858|147585644|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.24|STANDARD_DEVIATION|18.3||0.9635|TWO_SIDED|90.0|62.43|79.038|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||79.038|62.430|0.9635
74046183|NCT00565812|147644884|SUPERIORITY_OR_OTHER||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.83||0.68|TWO_SIDED|95.0|-1.97|1.29|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.29|-1.97|0.680
74096221|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.285||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.285
74096222|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.544||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.544
74096223|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.615||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.615
73880535|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.62||||0.046|TWO_SIDED|95.0|1.02|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.76|1.02|0.0460
73880536|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1215|TWO_SIDED|95.0|0.82|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.23|0.82|0.1215
73880537|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.75||||0.247|TWO_SIDED|95.0|0.68|4.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.48|0.68|0.2470
73880538|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2072|TWO_SIDED|95.0|0.72|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.66|0.72|0.2072
73880539|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0621|TWO_SIDED|95.0|0.95|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.94|0.95|0.0621
73880540|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|5.67||||0.0016|TWO_SIDED|95.0|1.93|16.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.69|1.93|0.0016
73880541|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4372|TWO_SIDED|95.0|0.56|3.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.84|0.56|0.4372
73880542|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.18||||0.11|TWO_SIDED|95.0|0.84|5.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.66|0.84|0.1100
73880543|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0533|TWO_SIDED|95.0|0.99|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.59|0.99|0.0533
73880544|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|4.68||||0.1769|TWO_SIDED|95.0|0.5|44.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||44.00|0.50|0.1769
73880545|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.26||||0.4942|TWO_SIDED|95.0|0.22|23.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||23.53|0.22|0.4942
73880546|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|12.82||||0.0214|TWO_SIDED|95.0|1.46|112.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||112.7|1.46|0.0214
73880547|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.93||||0.6013|TWO_SIDED|95.0|0.16|22.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||22.99|0.16|0.6013
73880548|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0537|TWO_SIDED|95.0|0.97|76.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||76.58|0.97|0.0537
73880549|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.8||||0.2662|TWO_SIDED|95.0|0.36|39.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||39.91|0.36|0.2662
73880550|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.51||||0.7431|TWO_SIDED|95.0|0.13|17.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||17.84|0.13|0.7431
73880551|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|3.53||||0.2829|TWO_SIDED|95.0|0.35|35.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||35.22|0.35|0.2829
73880552|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|2.12||||0.5311|TWO_SIDED|95.0|0.2|22.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||22.29|0.20|0.5311
73880553|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|4.71||||0.1857|TWO_SIDED|95.0|0.47|46.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||46.83|0.47|0.1857
73880554|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9879|TWO_SIDED|95.0|0.06|17.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||17.50|0.06|0.9879
74017095|NCT01703858|147585644|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.46|STANDARD_DEVIATION|18.7||0.2771|TWO_SIDED|90.0|73.774|94.412|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||94.412|73.774|0.2771
74017096|NCT01703858|147585644|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.16|STANDARD_DEVIATION|16.6||0.1584|TWO_SIDED|90.0|104.958|130.787|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||130.787|104.958|0.1584
74046184|NCT00565812|147644884|SUPERIORITY_OR_OTHER||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.82||0.73|TWO_SIDED|95.0|-1.33|1.9|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.90|-1.33|0.730
74046185|NCT00565812|147644884|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.84||0.901|TWO_SIDED|95.0|-1.55|1.76|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.76|-1.55|0.901
74046186|NCT00565812|147644884|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.84||0.333|TWO_SIDED|95.0|-2.45|0.83|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.83|-2.45|0.333
74046187|NCT00565812|147644885|SUPERIORITY_OR_OTHER||LS mean difference|2.34|STANDARD_ERROR_OF_MEAN|1.36||0.086|TWO_SIDED|95.0|-0.33|5.01|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||5.01|-0.33|0.086
74046188|NCT00565812|147644885|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|1.36||0.415|TWO_SIDED|95.0|-1.56|3.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.78|-1.56|0.415
74046189|NCT00565812|147644885|SUPERIORITY_OR_OTHER||LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|1.41||0.569|TWO_SIDED|95.0|-1.97|3.57|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.57|-1.97|0.569
74046190|NCT00565812|147644885|SUPERIORITY_OR_OTHER||LS mean difference|1.26|STANDARD_ERROR_OF_MEAN|1.41||0.374|TWO_SIDED|95.0|-1.51|4.02|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.02|-1.51|0.374
74046191|NCT00565812|147644885|SUPERIORITY_OR_OTHER||LS mean difference|1.63|STANDARD_ERROR_OF_MEAN|1.53||0.288|TWO_SIDED|95.0|-1.38|4.64|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.64|-1.38|0.288
74046192|NCT00565812|147644885|SUPERIORITY_OR_OTHER||LS mean difference|1.18|STANDARD_ERROR_OF_MEAN|1.52||0.44|TWO_SIDED|95.0|-1.81|4.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.17|-1.81|0.440
73880555|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|4.57||||0.1853|TWO_SIDED|95.0|0.48|43.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||43.19|0.48|0.1853
74046193|NCT00565812|147644885|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|1.58||0.896|TWO_SIDED|95.0|-3.3|2.88|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-3.30|0.896
74046194|NCT00565812|147644885|SUPERIORITY_OR_OTHER||LS mean difference|1.14|STANDARD_ERROR_OF_MEAN|1.56||0.464|TWO_SIDED|95.0|-1.92|4.2|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.20|-1.92|0.464
74017097|NCT01703858|147585644|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.41|STANDARD_DEVIATION|15.8||0.002|TWO_SIDED|90.0|88.066|107.741|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||107.741|88.066|0.0020
74017098|NCT00993031|147585651|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.76|TWO_SIDED|95.0|0.26|2.67|||Chi-squared|||||2.67|.26|.76
74017099|NCT00993031|147585652|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.76|TWO_SIDED|95.0|0.29|2.46|||Chi-squared|||||2.46|.29|.76
74017100|NCT00993031|147585653|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.45|TWO_SIDED|95.0|0.36|1.59|||Chi-squared|||||1.59|.36|.45
74017101|NCT00993031|147585655|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.22||||0.21|TWO_SIDED|95.0|0.89|1.66|||Chi-squared|||||1.66|.89|.21
74017102|NCT00993031|147585656|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.34||||0.06|TWO_SIDED|95.0|0.98|1.83|||Chi-squared|||||1.83|.98|.06
74017103|NCT03506295|147585670|OTHER||Odds Ratio (OR)|0.496||||0.7878|TWO_SIDED|95.0|0.168|1.469|||Regression, Logistic|||||1.469|0.168|0.7878
74017104|NCT03694925|147585695|OTHER||Specificity|0.871|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.|||||
74017105|NCT03694925|147585695|OTHER||Specificity|0.957|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.|||||
74017106|NCT03694925|147585695|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>14 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.|||||
74017107|NCT03694925|147585695|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>50 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.|||||
74017108|NCT03694925|147585695|OTHER||Positive predictive value|0.852|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
74017109|NCT03694925|147585695|OTHER||Positive predictive value|0.945|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
74017110|NCT03694925|147585695|OTHER||Negative predictive value|0.984|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
74017111|NCT03694925|147585695|OTHER||Negative predictive value|0.985|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
74017112|NCT03694925|147585696|OTHER||Specificity|0.829|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.|||||
74017113|NCT03694925|147585696|OTHER||Specificity|0.957|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.|||||
74017114|NCT03694925|147585696|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>14 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.|||||
74017115|NCT03694925|147585696|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>50 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.|||||
74017116|NCT03694925|147585696|OTHER||Positive predictive value|0.813|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
74017117|NCT03694925|147585696|OTHER||Positive predictive value|0.945|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
74017118|NCT03694925|147585696|OTHER||Negative predictive value|0.983|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
74017119|NCT03694925|147585696|OTHER||Negative predictive value|0.985|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. NPV=98.5%|||
74017120|NCT01639872|147585701|SUPERIORITY||difference in treatment means|0.014|STANDARD_ERROR_OF_MEAN|1.62||0.99|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.99
74017121|NCT01639872|147585702|SUPERIORITY||difference in treatment means|-0.32|STANDARD_ERROR_OF_MEAN|0.28||0.25|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.25
74017122|NCT03434977|147585719|OTHER||Ratio|0.937|||||TWO_SIDED|90.0|0.89|0.986||||||The shown data were ratio of fed conditions divided by fasted conditions, taking anti-logs of the least square (LS) means difference (fed-fasted) or confidence interval (CI). The difference in LS means between treatment conditions (fed-fasted) and two-sided 90% CI were provided using a crossover analysis of variance (ANOVA) model. ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.||0.986|0.890|
74017123|NCT03434977|147585720|OTHER||LS-Means Difference|0.9083|||||TWO_SIDED|90.0|0.1821|1.6345||||||The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (non-natural log) PK parameters tmax as dependent variable, and treatment condition, group, and period as independent variables.||1.6345|0.1821|
74017124|NCT03434977|147585721|OTHER||Ratio|0.998|||||TWO_SIDED|90.0|0.943|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.||1.056|0.943|
73880556|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|4.43||||0.217|TWO_SIDED|95.0|0.42|46.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||46.93|0.42|0.2170
74017125|NCT03434977|147585722|OTHER||Ratio|0.997|||||TWO_SIDED|90.0|0.942|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUC∞ as dependent variable, and treatment condition, group, and period as independent variables.||1.056|0.942|
74017126|NCT03434977|147585723|OTHER||Ratio|0.985|||||TWO_SIDED|90.0|0.932|1.041||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters T1/2z as dependent variable, and treatment condition, group, and period as independent variables.||1.041|0.932|
74017127|NCT03434977|147585724|OTHER||Ratio|1.047|||||TWO_SIDED|90.0|1.006|1.091||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRTlast, ev as dependent variable, and treatment condition, group, and period as independent variables.||1.091|1.006|
74096224|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.179||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.179
73880557|NCT03192176|147297623|SUPERIORITY||Odds Ratio (OR)|0.74||||0.8354|TWO_SIDED|95.0|0.04|12.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||12.62|0.04|0.8354
73880558|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9671|TWO_SIDED|95.0|0.06|16.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.04|0.06|0.9671
74017128|NCT03434977|147585725|OTHER||Ratio|1.037|||||TWO_SIDED|90.0|0.996|1.081||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRT∞, ev as dependent variable, and treatment condition, group, and period as independent variables.||1.081|0.996|
74017129|NCT03434977|147585726|OTHER||Ratio|1.014|||||TWO_SIDED|90.0|0.959|1.071||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters λz as dependent variable, and treatment condition, group, and period as independent variables.||1.071|0.959|
74017130|NCT03434977|147585727|OTHER||Ratio|1.003|||||TWO_SIDED|90.0|0.947|1.062||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters CL/F as dependent variable, and treatment condition, group, and period as independent variables.||1.062|0.947|
74096225|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.513||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.513
73880559|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.16||||0.3289|TWO_SIDED|95.0|0.31|31.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||31.87|0.31|0.3289
74017131|NCT03434977|147585728|OTHER||Ratio|0.989|||||TWO_SIDED|90.0|0.916|1.068||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Vz/F as dependent variable, and treatment condition, group, and period as independent variables.||1.068|0.916|
74017132|NCT06232317|147585773|SUPERIORITY|||||||0.61|||||||Kruskal-Wallis|||||||0.61
74096226|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.849||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.849
74017133|NCT06232317|147585774|SUPERIORITY|||||||0.014|||||||Kruskal-Wallis|||||||0.014
74017134|NCT06232317|147585779|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
74017135|NCT02321436|147585810|OTHER|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified log rank test.||||||0.0176||||||Significance level (α) = 5%|Log Rank|||||||0.0176
74017136|NCT02321436|147585810|OTHER|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified Wilcoxon test.||||||0.048||||||Significance level (α) = 5%|Wilcoxon (Mann-Whitney)|||||||0.0480
74017137|NCT02321436|147585811|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.0||||0.0005|TWO_SIDED|95.0|-1.54|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).||-0.47|-1.54|0.0005
73880560|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.26||||0.3157|TWO_SIDED|95.0|0.32|32.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||32.71|0.32|0.3157
74017138|NCT02321436|147585811|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0007|TWO_SIDED|95.0|-1.63|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).||-0.47|-1.63|0.0007
74017139|NCT02321436|147585811|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0006|TWO_SIDED|95.0|-1.62|-0.48||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).||-0.48|-1.62|0.0006
74017140|NCT02321436|147585811|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.84||||0.0027|TWO_SIDED|95.0|-1.36|-0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).||-0.31|-1.36|0.0027
74017141|NCT02321436|147585811|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.83||||0.0052|TWO_SIDED|95.0|-1.39|-0.26||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).||-0.26|-1.39|0.0052
74017142|NCT02321436|147585811|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.52||||0.2037|TWO_SIDED|95.0|-1.35|0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).||0.31|-1.35|0.2037
74017143|NCT02321436|147585811|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.15||||0.7656|TWO_SIDED|95.0|-1.25|0.94||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).||0.94|-1.25|0.7656
74017144|NCT02321436|147585811|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.12||||0.8521|TWO_SIDED|95.0|-1.46|1.23||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).||1.23|-1.46|0.8521
74017145|NCT02321436|147585811|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.21||||0.6582|TWO_SIDED|95.0|-1.24|0.81||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).||0.81|-1.24|0.6582
74096227|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.037
74096228|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.88||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.880
73880561|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.0||||0.991|TWO_SIDED|95.0|0.06|16.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.83|0.06|0.991
74017146|NCT02321436|147585812|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|0.8||||0.8754|TWO_SIDED|95.0|-9.5|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).||11.1|-9.5|0.8754
74017147|NCT02321436|147585812|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.9||||0.8805|TWO_SIDED|95.0|-12.8|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).||11.1|-12.8|0.8805
74017148|NCT02321436|147585812|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-2.2||||0.6992|TWO_SIDED|95.0|-14.0|9.6||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).||9.6|-14.0|0.6992
74017149|NCT02321436|147585812|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.1||||0.9882|TWO_SIDED|95.0|-13.0|12.8||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).||12.8|-13.0|0.9882
74017150|NCT02321436|147585812|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|4.6||||0.5646|TWO_SIDED|95.0|-11.9|21.2||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).||21.2|-11.9|0.5646
74017151|NCT02321436|147585812|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-12.5||||0.2325|TWO_SIDED|95.0|-34.0|9.0||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).||9.0|-34.0|0.2325
74017152|NCT02321436|147585812|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-14.1||||0.2441|TWO_SIDED|95.0|-39.4|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).||11.1|-39.4|0.2441
74017153|NCT02321436|147585812|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-9.0||||0.4311|TWO_SIDED|95.0|-33.7|15.7||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).||15.7|-33.7|0.4311
74017154|NCT02321436|147585812|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-4.5||||0.731|TWO_SIDED|95.0|-33.3|24.3||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).||24.3|-33.3|0.7310
74017155|NCT02321436|147585813|OTHER|||||||0.6128||||||The Cochran-Mantel-Haenszel (CMH) p-value represents the strength of the association between treatment and global assessments of changes at the last visit, adjusted for symptomatic status at baseline.|Cochran-Mantel-Haenszel|p value significance level = 5%||||||0.6128
74017156|NCT03048422|147585817|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|2.0|10.7||||||Difference in proportions for intention-to-treat analysis.||10.7|2.0|
74017157|NCT03048422|147585817|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|1.6|10.3||||||Difference in proportions for per-protocol analysis.||10.3|1.6|
74017158|NCT03048422|147585817|SUPERIORITY||Risk Difference (RD)|6.5||||0.005|TWO_SIDED|95.0|2.0|10.7|||Wald test of two proportions|||Difference in proportions for superiority and intention-to-treat analysis.||10.7|2.0|0.005
74017159|NCT03048422|147585818|SUPERIORITY||Risk Difference (RD)|-8.8||||0.043|TWO_SIDED|95.0|-17.3|-0.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||-0.3|-17.3|0.043
74017160|NCT03048422|147585818|SUPERIORITY||Risk Difference (RD)|0.2||||0.97|TWO_SIDED|95.0|-8.8|9.1|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||9.1|-8.8|0.97
74017161|NCT03048422|147585818|SUPERIORITY||Risk Difference (RD)|-8.6||||0.047|TWO_SIDED|95.0|-17.1|-0.1|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-0.1|-17.1|0.047
74017162|NCT03048422|147585819|SUPERIORITY||Risk Difference (RD)|-5.6||||0.098|TWO_SIDED|95.0|-14.2|2.9|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||2.9|-14.2|0.098
74017163|NCT03048422|147585819|SUPERIORITY||Risk Difference (RD)|2.6||||0.26|TWO_SIDED|95.0|-5.9|11.7|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TDF-EFV/FTC/TDF).||11.7|-5.9|0.26
74017164|NCT03048422|147585819|SUPERIORITY||Risk Difference (RD)|-2.8||||0.26|TWO_SIDED|95.0|-11.3|5.8|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF-EFV/FTC/TDF).||5.8|-11.3|0.26
73880562|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|2.26||||0.5139|TWO_SIDED|95.0|0.2|26.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||26.12|0.20|0.5139
74017165|NCT03048422|147585820|SUPERIORITY||Risk Difference (RD)|-3.2||||0.25|TWO_SIDED|95.0|-12.8|6.3|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of DTG+FTC/TAF - DTG+FTC/TDF.||6.3|-12.8|0.25
74017166|NCT03048422|147585820|SUPERIORITY||Risk Difference (RD)|-2.3||||0.32|TWO_SIDED|95.0|-12.1|7.5|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TDF-EFV/FTC/TDF.||7.5|-12.1|0.32
74017167|NCT03048422|147585820|SUPERIORITY||Risk Difference (RD)|-5.5||||0.11|TWO_SIDED|95.0|-14.3|3.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TAF-EFV/FTC/TDF.||3.2|-14.3|0.11
74017168|NCT03048422|147585821|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.0001|TWO_SIDED|95.0|9.3|22.0|||Wald test of two proportions|||Difference in proportions between arms for intention-to-treat analysis with null hypothesis of no difference (DTG groups - EFV/FTC/TDF).||22.0|9.3|< 0.0001
74017169|NCT03048422|147585822|SUPERIORITY||Risk Difference (RD)|-0.1||||0.97|TWO_SIDED|95.0|-3.3|3.2|||Wald test of two proportions|||Difference in proportions for intention-to-treat analysis with null hypothesis of no difference between arms (DTG arms - EFV/FTC/TDF).||3.2|-3.3|0.97
74017170|NCT03048422|147585823|SUPERIORITY||Hazard Ratio (HR)|2.4|||<|0.001|TWO_SIDED|95.0|1.9|3.1|||Kaplan-Meier|||||3.1|1.9|< 0.001
74017171|NCT03048422|147585824|SUPERIORITY||Risk Difference (RD)|3.6||||0.19|TWO_SIDED|95.0|-1.8|9.1|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - DTG+FTC/TDF).||9.1|-1.8|0.19
74017172|NCT03048422|147585824|SUPERIORITY||Risk Difference (RD)|-11.5|||<|0.001|TWO_SIDED|95.0|-17.9|-5.2|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TDF - EFV/FTC/TDF).||-5.2|-17.9|< 0.001
74017173|NCT03048422|147585824|SUPERIORITY||Risk Difference (RD)|-7.9||||0.022|TWO_SIDED|95.0|-14.6|-1.2|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - EFV/FTC/TDF).||-1.2|-14.6|0.022
74017174|NCT03048422|147585825|SUPERIORITY||Risk Difference (RD)|2.1||||0.61|TWO_SIDED|95.0|-5.9|10.1|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - DTG+FTC/TDF).||10.1|-5.9|0.61
74017175|NCT03048422|147585825|SUPERIORITY||Risk Difference (RD)|-1.4||||0.74|TWO_SIDED|95.0|-9.4|6.6|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TDF - EFV/FTC/TDF).||6.6|-9.4|0.74
74017176|NCT03048422|147585825|SUPERIORITY||Risk Difference (RD)|0.7||||0.86|TWO_SIDED|95.0|-7.4|8.8|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - EFV/FTC/TDF).||8.8|-7.4|0.86
74017177|NCT03048422|147585826|SUPERIORITY||Risk Difference (RD)|4.3||||0.27|TWO_SIDED|95.0|-3.4|11.9|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG groups - EFV/FTC/TDF).||11.9|-3.4|0.27
74017178|NCT03048422|147585827|SUPERIORITY||Risk Difference (RD)|-0.1||||0.49|TWO_SIDED|95.0|-7.6|7.5|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference combined DTG arms-EFV/FTC/TDF.||7.5|-7.6|0.49
74017179|NCT03048422|147585828|SUPERIORITY||Risk Difference (RD)|4.1||||0.15|TWO_SIDED|95.0|-3.8|12.0|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of combined DTG arms - EFV/FTC/TDF.||12.0|-3.8|0.15
74017180|NCT03048422|147585829|SUPERIORITY||Risk Difference (RD)|-8.8||||0.043|TWO_SIDED|95.0|-17.3|-0.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||-0.3|-17.3|0.043
74017181|NCT03048422|147585829|SUPERIORITY||Risk Difference (RD)|-0.3||||0.95|TWO_SIDED|95.0|-9.3|8.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||8.6|-9.3|0.95
74017182|NCT03048422|147585829|SUPERIORITY||Risk Difference (RD)|-9.1||||0.037|TWO_SIDED|95.0|-17.6|-0.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-0.6|-17.6|0.037
73880563|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.32||||0.3079|TWO_SIDED|95.0|0.33|33.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||33.45|0.33|0.3079
74017183|NCT03048422|147585830|SUPERIORITY||Odds Ratio (OR)|0.73||||0.095|TWO_SIDED|95.0|0.5|1.06|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TAF - DTG+FTC/TDF).||1.06|0.50|0.095
74017184|NCT03048422|147585830|SUPERIORITY||Odds Ratio (OR)|0.83||||0.3|TWO_SIDED|95.0|0.58|1.19|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TDF - EFV/FTC/TDF).||1.19|0.58|0.30
74017185|NCT03048422|147585830|SUPERIORITY||Odds Ratio (OR)|0.6||||0.008|TWO_SIDED|95.0|0.42|0.88|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TAF - EFV/FTC/TDF).||0.88|0.42|0.008
74017186|NCT03048422|147585831|SUPERIORITY||Risk Difference (RD)|0.5||||0.28|TWO_SIDED|95.0|-1.2|2.1|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||2.1|-1.2|0.28
73880564|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|8.83||||0.0469|TWO_SIDED|95.0|1.03|75.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||75.68|1.03|0.0469
74046195|NCT00565812|147644885|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.57||0.901|TWO_SIDED|95.0|-3.27|2.88|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-3.27|0.901
74046196|NCT00565812|147644885|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.56||0.8|TWO_SIDED|95.0|-3.45|2.66|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.66|-3.45|0.800
74046197|NCT00565812|147644886|SUPERIORITY_OR_OTHER||LS mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.048||0.984|TWO_SIDED|95.0|-0.093|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.095|-0.093|0.984
74046198|NCT00565812|147644886|SUPERIORITY_OR_OTHER||LS mean difference|-0.046|STANDARD_ERROR_OF_MEAN|0.048||0.33|TWO_SIDED|95.0|-0.14|0.047|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.047|-0.140|0.330
74046199|NCT00565812|147644886|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.049||0.308|TWO_SIDED|95.0|-0.146|0.046|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.046|-0.146|0.308
74046200|NCT00565812|147644886|SUPERIORITY_OR_OTHER||LS mean difference|-0.083|STANDARD_ERROR_OF_MEAN|0.049||0.089|TWO_SIDED|95.0|-0.18|0.013|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.013|-0.180|0.089
74046201|NCT00565812|147644886|SUPERIORITY_OR_OTHER||LS mean difference|-0.035|STANDARD_ERROR_OF_MEAN|0.052||0.508|TWO_SIDED|95.0|-0.137|0.068|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.068|-0.137|0.508
74046202|NCT00565812|147644886|SUPERIORITY_OR_OTHER||LS mean difference|-0.036|STANDARD_ERROR_OF_MEAN|0.052||0.49|TWO_SIDED|95.0|-0.137|0.066|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.066|-0.137|0.490
74046203|NCT00565812|147644886|SUPERIORITY_OR_OTHER||LS mean difference|-0.019|STANDARD_ERROR_OF_MEAN|0.057||0.739|TWO_SIDED|95.0|-0.132|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.094|-0.132|0.739
74046204|NCT00565812|147644886|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.057||0.376|TWO_SIDED|95.0|-0.162|0.061|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.061|-0.162|0.376
74046205|NCT00565812|147644886|SUPERIORITY_OR_OTHER||LS mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.057||0.883|TWO_SIDED|95.0|-0.121|0.104|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.104|-0.121|0.883
74046206|NCT00565812|147644886|SUPERIORITY_OR_OTHER||LS mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.057||0.69|TWO_SIDED|95.0|-0.135|0.089|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.089|-0.135|0.690
73880565|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|14.39||||0.0134|TWO_SIDED|95.0|1.74|119.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||119.1|1.74|0.0134
73880566|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|4.98||||0.1606|TWO_SIDED|95.0|0.53|46.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||46.90|0.53|0.1606
73880567|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|6.69||||0.0854|TWO_SIDED|95.0|0.77|58.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||58.35|0.77|0.0854
74017187|NCT03048422|147585831|SUPERIORITY||Risk Difference (RD)|-0.1||||0.47|TWO_SIDED|95.0|-1.5|1.4|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||1.4|-1.5|0.47
74017188|NCT03048422|147585831|SUPERIORITY||Risk Difference (RD)|0.4||||0.31|TWO_SIDED|95.0|-1.3|2.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||2.2|-1.3|0.31
74017189|NCT03048422|147585832|SUPERIORITY|The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of DTG+FTC/TAF - DTG+FTC/TDF.|Risk Difference (RD)|-1.0||||0.2|TWO_SIDED|95.0|-3.4|1.3|||Z-test|||||1.3|-3.4|0.20
74017190|NCT03048422|147585832|SUPERIORITY||Risk Difference (RD)|-4.9||||0.008|TWO_SIDED|95.0|-8.9|-0.9|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TDF-EFV/FTC/TDF.||-0.9|-8.9|0.008
74017191|NCT03048422|147585832|SUPERIORITY||Risk Difference (RD)|-5.9|||<|0.001|TWO_SIDED|95.0|-9.7|-2.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TAF-EFV/FTC/TDF.||-2.2|-9.7|<0.001
74017192|NCT03048422|147585833|SUPERIORITY||Mean Difference (Final Values)|-0.093||||0.12|TWO_SIDED|95.0|-0.208|0.023|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TAF - DTG+FTC/TDF).||0.023|-0.208|0.12
74017193|NCT03048422|147585833|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.39|TWO_SIDED|95.0|-0.061|0.158|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TDF - EFV/FTC/TDF).||0.158|-0.061|0.39
73880568|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|6.07||||0.1082|TWO_SIDED|95.0|0.67|54.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||54.72|0.67|0.1082
74017194|NCT03048422|147585833|SUPERIORITY||Mean Difference (Final Values)|-0.045||||0.45|TWO_SIDED|95.0|-0.161|0.072|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TAF - EFV/FTC/TDF).||0.072|-0.161|0.45
74017195|NCT03048422|147585834|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.94|TWO_SIDED|95.0|-11.3|10.5|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TAF - DTG+FTC/TDF).||10.5|-11.3|0.94
74017196|NCT03048422|147585834|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.44|TWO_SIDED|95.0|-6.5|14.9|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TDF - EFV/FTC/TDF).||14.9|-6.5|0.44
73888065|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|55.2||||0.01|TWO_SIDED|95.0|13.4|97.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||97.0|13.4|0.0100
74017197|NCT03048422|147585834|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.18|TWO_SIDED|95.0|-1.8|9.3|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TAF - EFV/FTC/TDF).||9.3|-1.8|0.18
74017198|NCT03048422|147585834|SUPERIORITY||Mean Difference (Final Values)|11.1||||0.27|TWO_SIDED|95.0|-8.9|31.1|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TAF - DTG+FTC/TDF).||31.1|-8.9|0.27
74017199|NCT03048422|147585834|SUPERIORITY||Mean Difference (Final Values)|-11.4||||0.048|TWO_SIDED|95.0|-22.6|-0.1|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TDF - EFV/FTC/TDF).||-0.1|-22.6|0.048
74017200|NCT03048422|147585834|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.98|TWO_SIDED|95.0|-21.0|20.5|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TAF - EFV/FTC/TDF).||20.5|-21.0|0.98
74017201|NCT03048422|147585835|SUPERIORITY||Risk Difference (RD)|-0.9||||0.4|TWO_SIDED|95.0|-3.1|1.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||1.3|-3.1|0.40
74017202|NCT03048422|147585835|SUPERIORITY||Risk Difference (RD)|-4.3||||0.023|TWO_SIDED|95.0|-8.0|-0.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||-0.6|-8.0|0.023
74017203|NCT03048422|147585835|SUPERIORITY||Risk Difference (RD)|-5.2||||0.003|TWO_SIDED|95.0|-8.7|-1.8|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-1.8|-8.7|0.003
74017204|NCT03048422|147585837|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-3.6||||0.16|TWO_SIDED|95.0|-8.8|1.5|||Wald test of two proportions|||||1.5|-8.8|0.16
73880569|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|7.22||||0.0737|TWO_SIDED|95.0|0.83|63.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||63.04|0.83|0.0737
74096229|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.153||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.153
74096230|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.073||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.073
74096231|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.007||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.007
74017205|NCT03048422|147585837|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-2.7||||0.38|TWO_SIDED|95.0|-8.7|3.3|||Wald test of two proportions|||||3.3|-8.7|0.38
74017206|NCT03048422|147585837|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-6.3||||0.023|TWO_SIDED|95.0|-11.8|-0.9|||Wald test of two proportions|||||-0.9|-11.8|0.023
74017207|NCT03048422|147585838|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-6.2||||0.12|TWO_SIDED|95.0|-13.9|1.5|||Wald test of two proportions|||||1.5|-13.9|0.12
74017208|NCT03048422|147585838|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|2.0||||0.63|TWO_SIDED|95.0|-6.0|10.0|||Wald test of two proportions|||||10.0|-6.0|0.63
74017209|NCT03048422|147585838|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-4.2||||0.28|TWO_SIDED|95.0|-11.7|3.4|||Wald test of two proportions|||||3.4|-11.7|0.28
74096232|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.791||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.791
73880570|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|11.98||||0.0217|TWO_SIDED|95.0|1.44|99.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||99.74|1.44|0.0217
73880571|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|19.24||||0.0058|TWO_SIDED|95.0|2.36|157.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||157.1|2.36|0.0058
74017210|NCT03048422|147585839|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.011|TWO_SIDED|95.0|0.013|0.103|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.103|0.013|0.011
74017211|NCT03048422|147585839|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.19|TWO_SIDED|95.0|-0.014|0.07|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.070|-0.014|0.19
74017212|NCT03048422|147585839|SUPERIORITY||Mean Difference (Final Values)|0.086|||<|0.001|TWO_SIDED|95.0|0.04|0.133|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.133|0.040|< 0.001
74017213|NCT03048422|147585840|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.11|TWO_SIDED|95.0|-0.005|0.048|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.048|-0.005|0.11
74017214|NCT03048422|147585840|SUPERIORITY||Mean Difference (Final Values)|0.024||||0.055|TWO_SIDED|95.0|0.0|0.049|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.049|-0.000|0.055
74017215|NCT03048422|147585840|SUPERIORITY||Mean Difference (Final Values)|0.046|||<|0.001|TWO_SIDED|95.0|0.022|0.07|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.070|0.022|< 0.001
74017216|NCT03048422|147585841|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.041|TWO_SIDED|95.0|0.001|0.045|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.045|0.001|0.041
74017217|NCT03048422|147585841|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.002|TWO_SIDED|95.0|0.013|0.055|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.055|0.013|0.002
74017218|NCT03048422|147585841|SUPERIORITY||Mean Difference (Final Values)|0.057|||<|0.001|TWO_SIDED|95.0|0.036|0.078|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.078|0.036|< 0.001
74017219|NCT03505021|147585842|SUPERIORITY||Mean Difference (Final Values)|0.258||||0.8253|TWO_SIDED|95.0|-2.032|2.547|||ANCOVA|||||2.547|-2.032|0.8253
74017220|NCT03505021|147585843|SUPERIORITY||Mean Difference (Final Values)|10.69||||0.4277|TWO_SIDED|95.0|-15.74|37.12|||ANCOVA|||||37.12|-15.74|0.4277
74096233|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.01||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.010
74096234|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.553||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.553
74096235|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.652||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.652
73880572|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|4.44||||0.1924|TWO_SIDED|95.0|0.47|41.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||41.87|0.47|0.1924
73880573|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|7.54||||0.068|TWO_SIDED|95.0|0.86|66.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||66.00|0.86|0.0680
73880574|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|15.95||||0.0095|TWO_SIDED|95.0|1.97|129.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||129.4|1.97|0.0095
74017221|NCT03505021|147585844|SUPERIORITY||Hazard Ratio (HR)|1.051||||0.6733|TWO_SIDED|95.0|0.833|1.327|||Regression, Cox|||||1.327|0.833|0.6733
74017222|NCT03505021|147585845|SUPERIORITY||Mean Difference (Final Values)|3.762||||0.1295|TWO_SIDED|95.0|-1.129|8.654|||ANCOVA|||||8.654|-1.129|0.1295
74017223|NCT03505021|147585846|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.623|TWO_SIDED|95.0|-0.04|0.066|||Mixed Models Analysis|||||0.066|-0.040|0.6230
74017224|NCT03505021|147585847|SUPERIORITY||Mean Difference (Final Values)|-0.272||||0.1752|TWO_SIDED|95.0|-0.666|0.122|||ANCOVA|||||0.122|-0.666|0.1752
74017225|NCT02392429|147585852|NON_INFERIORITY|we tested the null hypothesis that the NPV of the post-treatment FLT PET/CT scan was less than or equal to the NPV of the day 14 nadir bone marrow biopsy (estimated to be 0.64 by Hussein et al) against the one-sided alternative hypothesis that the NPV was greater than 0.64 using the exact binomial test.|||||>|0.99|||||||binomial exact test|||||||>0.99
74017226|NCT02392429|147585853|NON_INFERIORITY|we tested the null hypothesis that the PPV of the post-treatment FLT PET/CT scan was less than or equal to the PPV of the day 14 nadir bone marrow biopsy (estimated to be 0.79by Hussein et al) against the one-sided alternative hypothesis that the PPV was greater than 0.79 using the exact binomial test.||||||0.06|||||||binomial exact test|||||||0.06
74017227|NCT02392429|147585857|EQUIVALENCE|no margin was assumed||||||0.68|||||||log-rank test|||Kaplan-Meier curves were constructed for the positive and negative scan groups, and the null hypothesis that the survival distributions of the two groups were equal was tested using the log-rank test.||||0.68
73880575|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.68||||0.269|TWO_SIDED|95.0|0.36|37.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||37.21|0.36|0.2690
73880576|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|10.28||||0.0321|TWO_SIDED|95.0|1.22|86.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||86.53|1.22|0.0321
73888066|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2||||0.5379|TWO_SIDED|95.0|-29.0|55.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||55.4|-29.0|0.5379
74017228|NCT02392429|147585858|EQUIVALENCE|no margin was assumed||||||0.08|||||||log-rank test|||Kaplan-Meier curves were constructed for the positive and negative scan groups, and the null hypothesis that the survival distributions of the two groups were equal was tested using the log-rank test.||||0.08
74017229|NCT04137887|147585882|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the Confidence intervals (CIs) for relative vaccine effectiveness (rVE); expressed in percentage (%) was more than (\>) 0%.|Relative Vaccine Effectiveness|5.54|||||TWO_SIDED|95.0|-12.43|20.66|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|||20.66|-12.43|
74017230|NCT04137887|147585883|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the CIs for rVE, expressed in % was \> 0%.|Relative Vaccine Effectiveness|5.4|||||TWO_SIDED|95.0|-27.99|30.14|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|Statistical analysis for diseases of respiratory system.||30.14|-27.99|
74017231|NCT04137887|147585883|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the CIs for rVE, expressed in % was \> 0%.|Relative Vaccine Effectiveness|7.09|||||TWO_SIDED|95.0|-15.04|25.0|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|Statistical analysis for diseases of circulatory system.||25.00|-15.04|
74017232|NCT03193398|147585906|OTHER||Mean Difference (Net)|-1.3||||0.5939|TWO_SIDED|95.0|-6.3|3.6|||MMRM|MMRM: mixed model for repeated measures||Difference in LS Means (BTRX-246040 - Placebo)||3.6|-6.3|0.5939
74017233|NCT03193398|147585907|OTHER||Mean Difference (Net)|-1.0||||0.5503|TWO_SIDED|95.0|-4.4|2.3|||MMRM|MMRM: mixed model for repeated measures||Analysis of Change from Baseline in Investigator-administered MADRS-6 Total Score at week 8||2.3|-4.4|0.5503
74017234|NCT03193398|147585908|OTHER||Mean Difference (Net)|0.8||||0.3906|TWO_SIDED|95.0|-1.1|2.8|||MMRM|MMRM: mixed model for repeated measures||||2.8|-1.1|0.3906
74017235|NCT03193398|147585909|OTHER||Mean Difference (Net)|0.9||||0.4187|TWO_SIDED|95.0|-1.3|3.1||+/-|MMRM|MMRM: mixed model for repeated measures||||3.1|-1.3|0.4187
74017236|NCT03193398|147585910|OTHER||Mean Difference (Net)|-3.0||||0.4869|TWO_SIDED|95.0|-11.5|5.5|||MMRM|MMRM: mixed model for repeated measures||||5.5|-11.5|0.4869
74017237|NCT03193398|147585911|OTHER||Mean Difference (Net)|1.2||||0.5178|TWO_SIDED|95.0|-2.4|4.7|||MMRM|MMRM: mixed model for repeated measures||||4.7|-2.4|0.5178
74096236|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||< 0.001
74017238|NCT03806127|147585927|OTHER||Cochran-Mantel-Haenszel (CMH) Difference|-1.9|||||TWO_SIDED|90.0|-16.1|12.3|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.|||12.3|-16.1|
74017239|NCT03806127|147585928|OTHER||CMH Difference|9.1|||||TWO_SIDED|90.0|-4.8|22.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|IBS-D Participants||22.9|-4.8|
74017240|NCT03806127|147585928|OTHER||CMH Difference|-0.1|||||TWO_SIDED|90.0|-16.7|16.4|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|IBS-M Participants||16.4|-16.7|
74017241|NCT03806127|147585928|OTHER||CMH Difference|5.3|||||TWO_SIDED|90.0|-5.4|15.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|All Participants||15.9|-5.4|
74017242|NCT03806127|147585929|OTHER||CMH Difference|1.6|||||TWO_SIDED|90.0|-11.7|14.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|||14.9|-11.7|
74046207|NCT00565812|147644887|SUPERIORITY_OR_OTHER||LS mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.044||0.849|TWO_SIDED|95.0|-0.078|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.095|-0.078|0.849
74046208|NCT00565812|147644887|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.044||0.837|TWO_SIDED|95.0|-0.096|0.078|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.078|-0.096|0.837
74046209|NCT00565812|147644887|SUPERIORITY_OR_OTHER||LS mean difference|-0.013|STANDARD_ERROR_OF_MEAN|0.047||0.776|TWO_SIDED|95.0|-0.105|0.078|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.078|-0.105|0.776
74046210|NCT00565812|147644887|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.047||0.033|TWO_SIDED|95.0|-0.191|-0.008|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.008|-0.191|0.033
74096237|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.482||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.482
74017243|NCT03806127|147585930|OTHER||CMH Difference|6.7|||||TWO_SIDED|90.0|-5.5|18.8|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.|||18.8|-5.5|
74017244|NCT05030311|147585954|SUPERIORITY||Mean Difference (Final Values)|-6.22|STANDARD_ERROR_OF_MEAN|1.136|<|0.001|TWO_SIDED|95.0|-8.45|-4.0|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|||-4.00|-8.45|<0.001
74017245|NCT05030311|147585955|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.544|<|0.001|TWO_SIDED|95.0|-3.7|-1.56|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|ISS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-1.56|-3.70|<0.001
74017246|NCT05030311|147585956|SUPERIORITY||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|0.635|<|0.001|TWO_SIDED|95.0|-4.85|-2.36|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|HSS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-2.36|-4.85|<0.001
74017247|NCT05030311|147585957|SUPERIORITY||Odds Ratio (OR)|3.11|||<|0.001|TWO_SIDED|95.0|2.0|4.84|||Regression, Logistic|Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.||Disease activity control (UAS7 =\< 6) at Week 12||4.84|2.00|<0.001
74017248|NCT05030311|147585958|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.001|TWO_SIDED|95.0|2.16|6.82|||Regression, Logistic|Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.||Complete absence of hives and itch (UAS7 = 0) at Week 12||6.82|2.16|<0.001
74046211|NCT00565812|147644887|SUPERIORITY_OR_OTHER||LS mean difference|-0.064|STANDARD_ERROR_OF_MEAN|0.05||0.201|TWO_SIDED|95.0|-0.163|0.034|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.034|-0.163|0.201
73880577|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|14.48||||0.0131|TWO_SIDED|95.0|1.75|119.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||119.7|1.75|0.0131
74046212|NCT00565812|147644887|SUPERIORITY_OR_OTHER||LS mean difference|-0.103|STANDARD_ERROR_OF_MEAN|0.05||0.038|TWO_SIDED|95.0|-0.201|-0.006|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.006|-0.201|0.038
74046213|NCT00565812|147644887|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.053||0.848|TWO_SIDED|95.0|-0.114|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.094|-0.114|0.848
74046214|NCT00565812|147644887|SUPERIORITY_OR_OTHER||LS mean difference|-0.019|STANDARD_ERROR_OF_MEAN|0.052||0.714|TWO_SIDED|95.0|-0.122|0.084|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.084|-0.122|0.714
74046215|NCT00565812|147644887|SUPERIORITY_OR_OTHER||LS mean difference|0.025|STANDARD_ERROR_OF_MEAN|0.054||0.652|TWO_SIDED|95.0|-0.082|0.131|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.131|-0.082|0.652
74046216|NCT00565812|147644887|SUPERIORITY_OR_OTHER||LS mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.054||0.7|TWO_SIDED|95.0|-0.085|0.127|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.127|-0.085|0.700
74046217|NCT00565812|147644888|SUPERIORITY_OR_OTHER||LS mean difference|1.68|STANDARD_ERROR_OF_MEAN|1.37||0.22|TWO_SIDED|95.0|-1.0|4.36|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.36|-1.00|0.220
74046218|NCT00565812|147644888|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.36||0.997|TWO_SIDED|95.0|-2.67|2.68|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.68|-2.67|0.997
74046219|NCT00565812|147644888|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|1.44||0.613|TWO_SIDED|95.0|-2.09|3.55|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.55|-2.09|0.613
74046220|NCT00565812|147644888|SUPERIORITY_OR_OTHER||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|1.44||0.964|TWO_SIDED|95.0|-2.75|2.88|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-2.75|0.964
73880578|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|25.22||||0.0025|TWO_SIDED|95.0|3.11|204.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||204.6|3.11|0.0025
74046221|NCT00565812|147644888|SUPERIORITY_OR_OTHER||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|1.49||0.872|TWO_SIDED|95.0|-2.69|3.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.17|-2.69|0.872
73888067|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3||||0.8768|TWO_SIDED|95.0|-45.1|38.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.5|-45.1|0.8768
74046222|NCT00565812|147644888|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.48||0.947|TWO_SIDED|95.0|-2.81|3.01|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.01|-2.81|0.947
74046223|NCT00565812|147644888|SUPERIORITY_OR_OTHER||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|1.62||0.927|TWO_SIDED|95.0|-3.03|3.33|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.33|-3.03|0.927
74046224|NCT00565812|147644888|SUPERIORITY_OR_OTHER||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|1.61||0.547|TWO_SIDED|95.0|-2.18|4.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.12|-2.18|0.547
74046225|NCT00565812|147644888|SUPERIORITY_OR_OTHER||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|1.58||0.304|TWO_SIDED|95.0|-1.47|4.71|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.71|-1.47|0.304
74046226|NCT00565812|147644888|SUPERIORITY_OR_OTHER||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|1.57||0.679|TWO_SIDED|95.0|-3.73|2.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.43|-3.73|0.679
74046227|NCT00565812|147644889|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|1.11||0.738|TWO_SIDED|95.0|-1.8|2.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.55|-1.80|0.738
74046228|NCT00565812|147644889|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.11||0.632|TWO_SIDED|95.0|-2.7|1.64|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.64|-2.70|0.632
74096238|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.685||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.685
74017249|NCT05030311|147585959|SUPERIORITY||Odds Ratio (OR)|15.67|||<|0.001|TWO_SIDED|95.0|6.18|39.77|||Regression, Logistic||Statistical model used logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|||39.77|6.18|<0.001
74017250|NCT05030311|147585960|SUPERIORITY||Rate ratio|2.69|||<|0.001|TWO_SIDED|95.0|2.01|3.61|||Negative binomial regression model|Negative binomial regression model with log link, using treatment arm, geographical region, and prior exposure to anti-IgE biologics as covariates.||||3.61|2.01|<0.001
74017251|NCT05030311|147585961|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.53|3.9|||Regression, Logistic||Statistical model used logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics and baseline DLQI score.|||3.90|1.53|<0.001
74046229|NCT00565812|147644889|SUPERIORITY_OR_OTHER||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|1.21||0.736|TWO_SIDED|95.0|-2.77|1.96|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.96|-2.77|0.736
74096239|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.002||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.002
74096240|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.672||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.672
74096241|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.377||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.377
74017252|NCT05030311|147585962|SUPERIORITY||Rate ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.12|1.41|||Regression, Linear||Statistical model used a negative binomial regression with log link included treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics, baseline AAS7 = 0 response as covariates.|Angioedema occurrence-free weeks (AAS7 = 0 response) up to Week 12||1.41|1.12|<0.001
74046230|NCT00565812|147644889|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|1.21||0.811|TWO_SIDED|95.0|-2.66|2.08|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.08|-2.66|0.811
74017253|NCT03178487|147585984|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|Response Rate Difference|26.1|||<|0.001|TWO_SIDED|95.0|12.6|39.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for stratification factor of Screening hsCRP level.|Response Rate Difference = Upadacitinib - Placebo|||39.5|12.6|<0.001
74017254|NCT03178487|147585985|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|Least Squares (LS) Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.14|-0.68|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.68|-1.14|<0.001
74017255|NCT03178487|147585986|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|LS Mean Difference|-6.71|||<|0.001|TWO_SIDED|95.0|-9.01|-4.41|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-4.41|-9.01|<0.001
74017256|NCT03178487|147585987|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASDAI 50; within the group, the allocated α was adjusted based on the magnitude of p values.|Response Rate Difference|21.8||||0.002|TWO_SIDED|95.0|8.5|35.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|Response rate difference = Upadacitinib - Placebo|||35.0|8.5|0.002
74046231|NCT00565812|147644889|SUPERIORITY_OR_OTHER||LS mean difference|-1.22|STANDARD_ERROR_OF_MEAN|1.27||0.335|TWO_SIDED|95.0|-3.71|1.26|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.26|-3.71|0.335
74046232|NCT00565812|147644889|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|1.26||0.966|TWO_SIDED|95.0|-2.52|2.41|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.41|-2.52|0.966
74046233|NCT00565812|147644889|SUPERIORITY_OR_OTHER||LS mean difference|-1.44|STANDARD_ERROR_OF_MEAN|1.38||0.299|TWO_SIDED|95.0|-4.16|1.28|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.28|-4.16|0.299
74046234|NCT00565812|147644889|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.37||0.925|TWO_SIDED|95.0|-2.56|2.82|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.82|-2.56|0.925
74046235|NCT00565812|147644889|SUPERIORITY_OR_OTHER||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|1.39||0.676|TWO_SIDED|95.0|-2.14|3.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.30|-2.14|0.676
74046236|NCT00565812|147644889|SUPERIORITY_OR_OTHER||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|1.38||0.732|TWO_SIDED|95.0|-3.18|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.23|-3.18|0.732
74046237|NCT00565812|147644890|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.2||0.911|TWO_SIDED|95.0|-2.22|2.49|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.49|-2.22|0.911
74017257|NCT03178487|147585988|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including ASQoL; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-1.54||||0.016|TWO_SIDED|95.0|-2.78|-0.3|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.30|-2.78|0.016
74096242|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.015||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.015
74046238|NCT00565812|147644890|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|1.2||0.5|TWO_SIDED|95.0|-3.16|1.54|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.54|-3.16|0.500
74046239|NCT00565812|147644890|SUPERIORITY_OR_OTHER||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|1.26||0.596|TWO_SIDED|95.0|-1.81|3.15|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.15|-1.81|0.596
74046240|NCT00565812|147644890|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|1.26||0.979|TWO_SIDED|95.0|-2.51|2.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-2.51|0.979
74046241|NCT00565812|147644890|SUPERIORITY_OR_OTHER||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|1.33||0.659|TWO_SIDED|95.0|-3.2|2.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.03|-3.20|0.659
74046242|NCT00565812|147644890|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.32||0.823|TWO_SIDED|95.0|-2.89|2.3|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-2.89|0.823
74046243|NCT00565812|147644890|SUPERIORITY_OR_OTHER||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|1.43||0.387|TWO_SIDED|95.0|-4.04|1.57|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.57|-4.04|0.387
74046244|NCT00565812|147644890|SUPERIORITY_OR_OTHER||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|1.42||0.737|TWO_SIDED|95.0|-3.25|2.3|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-3.25|0.737
74046245|NCT00565812|147644890|SUPERIORITY_OR_OTHER||LS mean difference|1.12|STANDARD_ERROR_OF_MEAN|1.45||0.443|TWO_SIDED|95.0|-1.73|3.97|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.97|-1.73|0.443
74046246|NCT00565812|147644890|SUPERIORITY_OR_OTHER||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.44||0.585|TWO_SIDED|95.0|-3.62|2.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.04|-3.62|0.585
74017258|NCT03178487|147585989|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including ASAS PR; within the group, the allocated α was adjusted based on the magnitude of p values.|Response Rate Difference|18.3|||<|0.001|TWO_SIDED|95.0|10.0|26.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|Response rate difference = Upadacitinib - Placebo|||26.6|10.0|<0.001
74017259|NCT03178487|147585990|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASFI; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-1.0||||0.001|TWO_SIDED|95.0|-1.6|-0.39|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.39|-1.60|0.001
74046247|NCT00565812|147644891|SUPERIORITY_OR_OTHER||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|1.16||0.613|TWO_SIDED|95.0|-1.68|2.85|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.85|-1.68|0.613
74046248|NCT00565812|147644891|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|1.16||0.67|TWO_SIDED|95.0|-2.76|1.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-2.76|0.670
73880579|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|4.65||||0.1788|TWO_SIDED|95.0|0.49|43.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||43.72|0.49|0.1788
74017260|NCT03178487|147585991|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASMI(lin); within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-0.22||||0.03|TWO_SIDED|95.0|-0.43|-0.02|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.02|-0.43|0.030
73880580|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|10.33||||0.032|TWO_SIDED|95.0|1.22|87.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||87.31|1.22|0.0320
74017261|NCT03178487|147585992|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including MASES; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-0.84||||0.049|TWO_SIDED|95.0|-1.68|0.0|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.00|-1.68|0.049
74017262|NCT03178487|147585993|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including WPAI; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-5.52||||0.19|TWO_SIDED|95.0|-13.82|2.78|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||2.78|-13.82|0.190
74017263|NCT03178487|147585994|OTHER|"To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.~ASAS HI was to be evaluated only if the group of endpoints tested by Hochberg procedure were all significant."|LS Mean Difference|-1.37||||0.007|TWO_SIDED|95.0|-2.37|-0.37||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped during the Hochberg procedure.|Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.37|-2.37|0.007
74017264|NCT03178487|147585995|OTHER||Response Rate Difference|24.1||||0.001|TWO_SIDED|95.0|10.2|38.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|||Response Rate Difference = Upadacitinib - Placebo|38.0|10.2|0.001
74017265|NCT03178487|147585996|OTHER||LS Mean Difference|-3.69|||<|0.001|TWO_SIDED|95.0|-5.31|-2.08||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.08|-5.31|<0.001
74017266|NCT03178487|147585997|OTHER||LS Mean Difference|-6.21|||<|0.001|TWO_SIDED|95.0|-8.27|-4.14|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-4.14|-8.27|<0.001
74017267|NCT03178487|147585998|OTHER||LS Mean Difference|-2.55|||<|0.001|TWO_SIDED|95.0|-4.01|-1.08|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.08|-4.01|<0.001
74017268|NCT04781816|147586003|SUPERIORITY||Least Square Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|7.53|||TWO_SIDED|90.0|-18.26|6.85||||||Analysis was performed using mixed model with repeated measurements (MMRM) including fixed effects for baseline CLASI-A, post-baseline visit, geographical region, disease subtype, baseline use of CQ/HCQ, intervention group, visit-by- intervention group interaction, and visit-by-baseline-CLASI-A interaction.||6.85|-18.26|
74017269|NCT01789970|147586022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|||<|0.001|TWO_SIDED|95.0|0.26|1.0||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in WPI were compared between the active drug and placebo treatment groups.||1.00|0.26|<0.001
74017270|NCT01789970|147586023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|||<|0.001|TWO_SIDED|95.0|0.25|0.91||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in API were compared between the active drug and placebo treatment groups.||0.91|0.25|<0.001
74017271|NCT01789970|147586024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.059|TWO_SIDED|95.0|0.5|1.01||5% significance level|Wald chi-square|Cox proportional hazards model with treatment, baseline worst pain intensity (WPI), opioid status, and center in the model||||1.01|0.5|0.059
74017272|NCT01789970|147586025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.0293|TWO_SIDED|95.0|0.47|0.96||5% significance level|Regression, Logistic|stratified by center with the following effects: treatment group, baseline API, and opioid status.|Hydrocodone ER / Placebo|API increase \>=30% and API \>=5||0.96|0.47|0.0293
74096243|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.086
74017273|NCT01789970|147586026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.557|TWO_SIDED|95.0|-1.2|0.65||5% significance level|ANCOVA|Model with the following effects: treatment, study center, opioid status, and baseline RMDQ score.|Placebo - Hydrocodone ER|||0.65|-1.20|0.557
74017274|NCT01121393|147586034|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on PFS compared with gemcitabine / cisplatin chemotherapy.||||<0.0001
74017275|NCT01121393|147586034|SUPERIORITY||Hazard Ratio (HR)|0.281|||||TWO_SIDED|95.0|0.203|0.389||||||A Cox proportional-hazards model, stratified by EGFR mutation category was used to estimate the hazard ratio (HR) and 95% confidence interval (CI) between the 2 treatment arms.||0.389|0.203|
74096244|NCT03118570|147741800|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.712||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.712
74017276|NCT01121393|147586035|SUPERIORITY||Odds Ratio (OR)|7.572|||<|0.0001|TWO_SIDED|95.0|4.522|12.679|||Regression, Logistic|||A logistic regression model, stratified by EGFR mutation category was used to compare the objective response rate between the 2 treatment arms.||12.679|4.522|<0.0001
74017277|NCT01121393|147586036|SUPERIORITY||Odds Ratio (OR)|3.843|||<|0.0001|TWO_SIDED|95.0|2.039|7.24|||Regression, Logistic|||stratified for EGFR mutation group||7.240|2.039|<0.0001
74017278|NCT01121393|147586037|SUPERIORITY|||||||0.4013|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.||||0.4013
74017279|NCT01121393|147586037|SUPERIORITY||Hazard Ratio (HR)|0.904|||||TWO_SIDED|95.0|0.715|1.144||||||A Cox proportional hazard model stratified (by EGFR mutation category stratification factor used at randomisation) was used to test the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.||1.144|0.715|
74017280|NCT01121393|147586041|SUPERIORITY||Mean Difference (Final Values)|-13.64|STANDARD_ERROR_OF_MEAN|1.76|<|0.0001|TWO_SIDED|95.0|-17.1|-10.19|||ANCOVA|adjusted for baseline sum of diameters and EGFR mutation group||||-10.19|-17.10|<0.0001
74017281|NCT01121393|147586044|SUPERIORITY|||||||0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||0.0001
74017282|NCT01121393|147586044|SUPERIORITY||Hazard Ratio (HR)|0.458|||||TWO_SIDED|95.0|0.303|0.692||||||Cox proportional hazard model stratified by EGFR mutation group||0.692|0.303|
74017283|NCT01121393|147586045|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||<0.0001
74017284|NCT01121393|147586045|SUPERIORITY||Hazard Ratio (HR)|0.534|||||TWO_SIDED|95.0|0.394|0.724||||||Cox proportional hazard model stratified by EGFR mutation group||0.724|0.394|
74096245|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.045||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.045
74017285|NCT01121393|147586046|SUPERIORITY|||||||0.022|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||0.0220
74017286|NCT01121393|147586046|SUPERIORITY||Hazard Ratio (HR)|0.699|||||TWO_SIDED|95.0|0.511|0.956||||||Cox proportional hazard model stratified by EGFR mutation group||0.956|0.511|
74017287|NCT02123485|147586052|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
74017288|NCT03423342|147586055|SUPERIORITY||Mean Difference (Net)|30.2|STANDARD_ERROR_OF_MEAN|3.3|<|0.0001|TWO_SIDED|||||The updated p-value is calculated and not a threshold for statistical significance.|t-test, 2 sided|||||||<0.0001
74017289|NCT03423342|147586056|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
74017290|NCT03423342|147586057|SUPERIORITY||Mean Difference (Net)|19.0|STANDARD_ERROR_OF_MEAN|48.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
74017291|NCT03423342|147586058|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|17.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
74017292|NCT03423342|147586059|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|3.1|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
74017293|NCT03423342|147586060|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.66|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
74017294|NCT02296242|147586061|OTHER||Highest dose (mg) with no DLTs.|600.0|||||TWO_SIDED|||||||||In Part 1, 2 patients experienced DLTs in the 750 mg b.i.d. treatment group (2/7; 29%). There were no dose-limiting toxicities in the 600 mg b.i.d. group or 300 mg b.i.d. group. Therefore, based on these results, 600 mg b.i.d. was selected as the MTD dose (and RP2D dose) which was used as the treatment dose in Part 2 of the study.||||
74017295|NCT00119158|147586071|NON_INFERIORITY_OR_EQUIVALENCE|modified EASI (eczema area severity index) was considered equivalent if p value was greater than \>0.05|||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
74017296|NCT00608985|147586085|SUPERIORITY_OR_OTHER||Median Difference (Net)|-15.0|||<|0.0001|TWO_SIDED|95.0|-21.8|-8.8|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-8.8|-21.8|<0.0001
74017297|NCT00608985|147586085|SUPERIORITY_OR_OTHER||Median Difference (Net)|-26.8|||<|0.0001|TWO_SIDED|95.0|-34.3|-19.5|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-19.5|-34.3|<0.0001
74017298|NCT00608985|147586085|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.8||||0.0376|TWO_SIDED|95.0|-13.5|-0.3|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-0.3|-13.5|0.0376
74017299|NCT00608985|147586086|SUPERIORITY_OR_OTHER||Median Difference (Net)|-13.5||||0.0001|TWO_SIDED|95.0|-20.3|-6.5|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-6.5|-20.3|0.0001
74046249|NCT00565812|147644891|SUPERIORITY_OR_OTHER||LS mean difference|-1.33|STANDARD_ERROR_OF_MEAN|1.27||0.296|TWO_SIDED|95.0|-3.82|1.16|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.16|-3.82|0.296
74046250|NCT00565812|147644891|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|1.27||0.604|TWO_SIDED|95.0|-3.15|1.83|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.83|-3.15|0.604
74046251|NCT00565812|147644891|SUPERIORITY_OR_OTHER||LS mean difference|-1.86|STANDARD_ERROR_OF_MEAN|1.33||0.163|TWO_SIDED|95.0|-4.46|0.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.75|-4.46|0.163
74046252|NCT00565812|147644891|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.32||0.939|TWO_SIDED|95.0|-2.69|2.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.48|-2.69|0.939
74046253|NCT00565812|147644891|SUPERIORITY_OR_OTHER||LS mean difference|-1.74|STANDARD_ERROR_OF_MEAN|1.46||0.233|TWO_SIDED|95.0|-4.61|1.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.12|-4.61|0.233
74046254|NCT00565812|147644891|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|1.45||0.72|TWO_SIDED|95.0|-2.32|3.36|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.36|-2.32|0.720
74046255|NCT00565812|147644891|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.45||0.993|TWO_SIDED|95.0|-2.82|2.85|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.85|-2.82|0.993
74096246|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.101||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.101
74096247|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.482||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.482
74096248|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.011
74046256|NCT00565812|147644891|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|1.44||0.794|TWO_SIDED|95.0|-3.19|2.44|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-3.19|0.794
74096249|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.508||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.508
74096250|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.563||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.563
74096251|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.917||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.917
73880581|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|11.24||||0.0251|TWO_SIDED|95.0|1.35|93.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||93.33|1.35|0.0251
73880582|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.43||||0.6154|TWO_SIDED|95.0|0.35|5.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.83|0.35|0.6154
74017300|NCT00608985|147586086|SUPERIORITY_OR_OTHER||Median Difference (Net)|-19.5|||<|0.0001|TWO_SIDED|95.0|-27.3|-12.3|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-12.3|-27.3|<0.0001
74046257|NCT00565812|147644892|SUPERIORITY_OR_OTHER||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|0.53||0.069|TWO_SIDED|95.0|-0.07|2.02|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.02|-0.07|0.069
74046258|NCT00565812|147644892|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.54||0.335|TWO_SIDED|95.0|-0.53|1.57|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.57|-0.53|0.335
74046259|NCT00565812|147644892|SUPERIORITY_OR_OTHER||LS mean difference|0.89|STANDARD_ERROR_OF_MEAN|0.62||0.153|TWO_SIDED|95.0|-0.33|2.11|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.11|-0.33|0.153
74046260|NCT00565812|147644892|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.672|TWO_SIDED|95.0|-0.95|1.47|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.47|-0.95|0.672
74046261|NCT00565812|147644892|SUPERIORITY_OR_OTHER||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.63||0.765|TWO_SIDED|95.0|-1.05|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.43|-1.05|0.765
74046262|NCT00565812|147644892|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.675|TWO_SIDED|95.0|-0.96|1.49|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.49|-0.96|0.675
74096252|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.789||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.789
74017301|NCT00608985|147586086|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.5||||0.3358|TWO_SIDED|95.0|-3.8|11.0|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||11.0|-3.8|0.3358
74017302|NCT00608985|147586087|SUPERIORITY_OR_OTHER||Median Difference (Net)|-7.3||||0.0186|TWO_SIDED|95.0|-13.3|-1.3|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-1.3|-13.3|0.0186
74017303|NCT00608985|147586087|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.4||||0.0006|TWO_SIDED|95.0|-16.4|-4.6|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-4.6|-16.4|0.0006
74046263|NCT00565812|147644892|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.72||0.56|TWO_SIDED|95.0|-1.0|1.84|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.84|-1.00|0.560
74096253|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.262||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.262
73880583|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1906|TWO_SIDED|95.0|0.65|8.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.63|0.65|0.1906
74046264|NCT00565812|147644892|SUPERIORITY_OR_OTHER||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.72||0.433|TWO_SIDED|95.0|-0.84|1.97|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.97|-0.84|0.433
74046265|NCT00565812|147644892|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.73||0.318|TWO_SIDED|95.0|-0.7|2.16|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.16|-0.70|0.318
74046266|NCT00565812|147644892|SUPERIORITY_OR_OTHER||LS mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.73||0.303|TWO_SIDED|95.0|-0.68|2.18|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.18|-0.68|0.303
74046267|NCT00565812|147644893|SUPERIORITY_OR_OTHER||LS mean difference|1.67|STANDARD_ERROR_OF_MEAN|0.81||0.039|TWO_SIDED|95.0|0.08|3.26|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLGU\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.26|0.08|0.039
74096254|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.426||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.426
74017304|NCT00608985|147586087|SUPERIORITY_OR_OTHER||Median Difference (Net)|-12.7|||<|0.0001|TWO_SIDED|95.0|-18.8|-6.6|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-6.6|-18.8|<0.0001
74017305|NCT00608985|147586088|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.3||||0.0035|TWO_SIDED|95.0|-15.3|-3.0|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-3.0|-15.3|0.0035
74017306|NCT00608985|147586088|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.5||||0.0006|TWO_SIDED|95.0|-15.0|-4.3|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-4.3|-15.0|0.0006
74017307|NCT00608985|147586088|SUPERIORITY_OR_OTHER||Median Difference (Net)|-16.0|||<|0.0001|TWO_SIDED|95.0|-22.0|-9.8|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-9.8|-22.0|<0.0001
74017308|NCT00608985|147586089|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0||||0.2237|TWO_SIDED|95.0|-11.0|2.5|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||2.5|-11.0|0.2237
74017309|NCT00608985|147586089|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.0||||0.0607|TWO_SIDED|95.0|-12.3|0.3|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||0.3|-12.3|0.0607
74017310|NCT00608985|147586089|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.5||||0.0017|TWO_SIDED|95.0|-17.3|-4.0|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-4.0|-17.3|0.0017
74017311|NCT00608985|147586090|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.1||||0.1187|TWO_SIDED|95.0|-9.1|0.9|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||0.9|-9.1|0.1187
74017312|NCT00608985|147586090|SUPERIORITY_OR_OTHER||Median Difference (Net)|-7.1||||0.0017|TWO_SIDED|95.0|-11.5|-2.7|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-2.7|-11.5|0.0017
74017313|NCT00608985|147586090|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.1||||0.0121|TWO_SIDED|95.0|-10.8|-1.4|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-1.4|-10.8|0.0121
74017314|NCT04311086|147586127|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
74017315|NCT04311086|147586128|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
74017316|NCT04311086|147586129|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment||||>0.05
74017317|NCT04311086|147586130|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
74017318|NCT04311086|147586134|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||<|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||<0.05
74017319|NCT04311086|147586135|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||<|0.05|||||||ANCOVA|||||||<0.05
74017320|NCT04311086|147586136|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
74017321|NCT04311086|147586137|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
74017322|NCT02499029|147586219|SUPERIORITY|||||||0.05|||||||Regression, Linear|||A series of hierarchical linear regression analyses were conducted to examine the effects of treatment group (NAC or placebo) on PTSD symptomatology, craving, substance use, and depression. Baseline levels of the respective outcome measures were entered in Step 1 of the model to adjust for any baseline differences. Treatment group was entered as the predictor in Step 2. The significance threshold was set at a p-value of .05 (two-sided) for all statistical tests.||||.05
74017323|NCT03439033|147586224|SUPERIORITY||Risk Difference (RD)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.53|||McNemar||Risk difference reflects PSMA PET/MRI Scan detection proportion minus MRI scan detection proportion.|||0.53|0.30|<0.0001
74017324|NCT01849770|147586243|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|0.4||0.561|TWO_SIDED|95.0|-1.03|0.56|||Random slopes model|||||0.56|-1.03|0.561
74017325|NCT01849770|147586243|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.43||0.662|TWO_SIDED|95.0|-1.04|0.66|||Random slopes model|||||0.66|-1.04|0.662
74017326|NCT01849770|147586244|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.71|STANDARD_ERROR_OF_MEAN|1.25||0.178|TWO_SIDED|95.0|-0.8|4.22|||Random slopes model|||||4.22|-0.80|0.178
74046268|NCT00565812|147644893|SUPERIORITY_OR_OTHER||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.82||0.395|TWO_SIDED|95.0|-0.91|2.3|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.91|0.395
74017327|NCT01849770|147586244|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.94|STANDARD_ERROR_OF_MEAN|1.42||0.51|TWO_SIDED|95.0|-3.8|1.91|||Random slopes model|||||1.91|-3.80|0.510
74017328|NCT04925752|147586258|SUPERIORITY||Rate Ratio|0.043|||<|0.0001|TWO_SIDED|95.0|0.01|0.182||p-value for rate ratio vs bHIV is from Wald test.|Wald test||Confidence Interval (CI) for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 01: LEN/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than bHIV.||0.182|0.010|<0.0001
74017329|NCT04925752|147586258|SUPERIORITY||Rate Ratio|0.043|||<|0.0001|TWO_SIDED|95.0|0.01|0.182||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 02: LEN/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly and at least 20% lower than bHIV.||0.182|0.010|< 0.0001
74017330|NCT04925752|147586259|OTHER|Null Hypothesis 03: LEN - F/TDF\>= 0.8/100PY; Null hypothesis was to be rejected if HIV-1 incidence in LEN is not substantially greater than F/TDF (LEN is comparable to F/TDF).|Rate difference|-0.828|||<|0.0001|TWO_SIDED|95.0|-1.669|-0.255||p-value for rate difference (SC LEN minus F/TDF) is based on a hybrid approach.|Hybrid approach||Exact CI for rate difference versus F/TDF is based on a hybrid approach.|||-0.255|-1.669|<0.0001
74017331|NCT04925752|147586259|SUPERIORITY||Rate Ratio|0.111||||0.00245|TWO_SIDED|95.0|0.024|0.513||P-value for rate ratio versus F/TDF is from a Poisson model.|Poisson model||Confidence interval for rate ratio versus F/TDF is from a Poisson model.|Null Hypothesis 04: LEN vs F/TDF\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than F/TDF.||0.513|0.024|0.00245
74017332|NCT00866307|147586269|SUPERIORITY_OR_OTHER_LEGACY||Percentage|50.0|||||TWO_SIDED|90.0|35.6|64.4|||Agresti-Coull Confidence Interval|||Per protocol, percentage of high risk-High patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy is compared to a null fixed rate (\<=73%). A 90% two-sided Agresti-Coull confidence interval will be constructed and the lower bound examined. Will reject null if lower bound of confidence interval is above 73%.||64.4|35.6|
74017333|NCT00866307|147586270|SUPERIORITY_OR_OTHER_LEGACY||Percentage|53.3|||||TWO_SIDED|90.0|38.7|67.4|||Agresti-Coull Confidence Interval|||Per protocol, percentage receiving at least 8 doses is compared to a null fixed rate (\<=42%). A 90% two-sided Agresti-Coull confidence interval will be constructed. Will reject null if lower bound of confidence interval is above 42%.||67.4|38.7|
74017334|NCT05574062|147586295|NON_INFERIORITY|-7.5% non-inferiority margin|Mean Difference (Final Values)|9.88|||||TWO_SIDED|95.0|8.04|11.72|||Mixed Models Analysis||Mixed model adjusted for baseline (run-in) values|||11.72|8.04|
74017335|NCT05574062|147586296|NON_INFERIORITY|non-inferiority margin of 0.4% HbA1c|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.03|0.31|||Regression, Linear||Linear regression model adjusted for baseline (continuation phase period1) values|||0.31|-0.03|
74017336|NCT05574062|147586297|NON_INFERIORITY|non- inferiority margin of 0.4%|Mean Difference (Final Values)|-0.61|||||TWO_SIDED|95.0|-0.76|-0.46|||Mixed Models Analysis||Mixed model adjusted for baseline (screening) values|||-0.46|-0.76|
74017337|NCT05574062|147586298|SUPERIORITY||Median Difference (Final Values)|9.88|||<|0.0001|TWO_SIDED|95.0|8.04|11.72|||Mixed Models Analysis||Mixed model adjusted for baseline (run-in) values|||11.72|8.04|<.0001
74017338|NCT05574062|147586299|SUPERIORITY||Mean Difference (Net)|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.46|||Mixed Models Analysis||Mixed model adjusted for baseline (screening) values|||-0.46|-0.76|<.0001
74017339|NCT05574062|147586300|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.1097|TWO_SIDED|95.0|-0.03|0.31|||Regression, Linear||Linear regression model adjusted for baseline (period1) values|||0.31|-0.03|0.1097
74017340|NCT05574062|147586301|NON_INFERIORITY|non inferiority margin of -7.5%|Mean Difference (Net)|1.17|||||TWO_SIDED|95.0|-0.04|2.38|||Regression, Linear||Linear regression adjusted for baseline (continuation phase period 1) values|||2.38|-0.04|
74017341|NCT05574062|147586302|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.0581|TWO_SIDED|95.0|-0.04|2.38|||Regression, Linear||Linear regression adjusted for baseline (continuation phase period 1) values|||2.38|-0.04|0.0581
74017342|NCT06033079|147586336|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.32|2.95||||||||2.95|0.32|
74046269|NCT00565812|147644893|SUPERIORITY_OR_OTHER||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|0.96||0.16|TWO_SIDED|95.0|-0.54|3.25|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.25|-0.54|0.160
74046270|NCT00565812|147644893|SUPERIORITY_OR_OTHER||LS mean difference|0.46|STANDARD_ERROR_OF_MEAN|0.97||0.638|TWO_SIDED|95.0|-1.44|2.35|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.35|-1.44|0.638
74017343|NCT06033079|147586337|SUPERIORITY|||||||0.233|||||||Fisher Exact|||||||0.233
74017344|NCT06033079|147586338|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.3|2.37||||||||2.37|0.30|
74017345|NCT06033079|147586339|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.32|1.82||||||||1.82|0.32|
74017346|NCT06033079|147586340|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.34|7.51||||||||7.51|0.34|
74017347|NCT06033079|147586341|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.13|1.42||||||||1.42|0.13|
74017348|NCT06033079|147586342|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|0.41|7.9||||||||7.90|0.41|
74017349|NCT04202679|147586347|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0216|TWO_SIDED|95.0|1.08|5.0||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05.||5.00|1.08|0.0216
74017350|NCT04202679|147586348|SUPERIORITY||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|3.56|22.66||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||22.66|3.56|<0.0001
74017351|NCT04202679|147586349|SUPERIORITY||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.02|9.55||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||9.55|2.02|<0.0001
74017352|NCT04202679|147586350|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0001|TWO_SIDED|95.0|2.03|18.11||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05||18.11|2.03|0.0001
74017353|NCT04202679|147586351|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0194|TWO_SIDED|95.0|1.13|7.52||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||7.52|1.13|0.0194
74017354|NCT04202679|147586352|SUPERIORITY||LS mean difference|-23.16|||<|0.0001|TWO_SIDED|95.0|-33.81|-12.51||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-12.51|-33.81|<0.0001
74017355|NCT04202679|147586353|SUPERIORITY||LS mean difference|-6.39|||<|0.0001|TWO_SIDED|95.0|-8.42|-4.36||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-4.36|-8.42|<0.0001
74017356|NCT04202679|147586354|SUPERIORITY||LS mean difference|-1.61||||0.0003|TWO_SIDED|95.0|-2.49|-0.73||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-0.73|-2.49|0.0003
74017357|NCT04202679|147586355|SUPERIORITY||LS mean difference|0.54||||0.1658|TWO_SIDED|95.0|-0.22|1.3||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||1.30|-0.22|0.1658
74017358|NCT04202679|147586363|SUPERIORITY||LS mean difference|-0.61||||0.037|TWO_SIDED|95.0|-1.18|-0.04||Threshold of significance was \<0.05.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|||-0.04|-1.18|0.0370
74017359|NCT01680900|147586373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.05|TWO_SIDED|95.0|-2.6|-0.48|||Regression, Linear|||||-0.48|-2.60|0.05
74017360|NCT01680900|147586374|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
74017361|NCT01680900|147586375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.05|TWO_SIDED|95.0|-0.75|-0.08|||Regression, Linear|||||-0.08|-0.75|<0.05
74017362|NCT01680900|147586379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.05|TWO_SIDED|95.0|-0.74|-0.21|||Regression, Linear|||||-0.21|-0.74|0.05
74017363|NCT00546052|147586380|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.74||0.999||95.0|-0.02|0.06|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5%.||0.06|-0.02|0.999
74017364|NCT00546052|147586381|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.62||0.999||95.0|0.01|0.07|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5mmol/L.||0.07|0.01|0.999
74017365|NCT00546052|147586383|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.95|STANDARD_DEVIATION|13.34|<|0.001||95.0|-17.62|-16.27|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg||-16.27|-17.62|<0.001
74017366|NCT00546052|147586384|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.84|STANDARD_DEVIATION|8.39|<|0.001||95.0|-10.29|-9.39|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg.||-9.39|-10.29|<0.001
74017367|NCT00546052|147586385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|5.4|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||<0.001
74017368|NCT00546052|147586386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_DEVIATION|5.2|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||<0.001
74017369|NCT00546052|147586387|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.5|STANDARD_DEVIATION|32.1||0.084|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.084
74017370|NCT00546052|147586388|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|18.0||0.654|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.654
74017371|NCT00546052|147586389|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|43.5||0.336|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.336
74017372|NCT00546052|147586390|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|17.0||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.001
74017373|NCT00546052|147586391|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.2|STANDARD_DEVIATION|63.8||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.001
74017374|NCT00546052|147586392|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|8.7||0.613|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.613
74017375|NCT01928381|147586404|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.23||0.5695|TWO_SIDED|95.0|-0.34|0.61|||Mixed Models Analysis|||||0.61|-0.34|0.5695
74017376|NCT01928381|147586404|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.23||0.8905|TWO_SIDED|95.0|-0.43|0.49|||Mixed Models Analysis|||||0.49|-0.43|0.8905
74017377|NCT01928381|147586404|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4822|TWO_SIDED|95.0|-0.3|0.64|||Mixed Models Analysis|||||0.64|-0.30|0.4822
74017378|NCT01928381|147586405|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.25||0.2237|TWO_SIDED|95.0|-0.2|0.82|||Mixed Models Analysis||In direction of Pregabalin|||0.82|-0.20|0.2237
74017379|NCT01928381|147586405|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.25||0.0978|TWO_SIDED|95.0|-0.93|0.08|||Mixed Models Analysis||In direction of Pregabain, positive control|||0.08|-0.93|0.0978
74017380|NCT01928381|147586405|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.25||0.661|TWO_SIDED|95.0|-0.62|0.4|||Mixed Models Analysis|||||0.40|-0.62|0.6610
74017381|NCT04770753|147586441|SUPERIORITY||Percentage difference|40.9|||<|0.0001|TWO_SIDED|95.0|32.0|49.8|||Cochran-Mantel-Haenszel|||The estimated adjusted difference in response rate, 95% CI, and p-value are based on Mantel-Haenszel stratum weighted method adjusting for the randomization stratification factors.||49.8|32.0|<0.0001
74017382|NCT04770753|147586442|SUPERIORITY||Difference in Lean Square (LS) Mean|3.4||||0.0026|TWO_SIDED|95.0|1.21|5.59|||ANCOVA|||The estimates, 95% CIs, and 2-sided p-value are based on an analysis of covariance (ANCOVA) model which includes average change from baseline in FACIT-Fatigue subscale score from Week 12 through Week 24 as the dependent variable, treatment group as the independent variable, and baseline and the randomization stratification factors as covariates.||5.59|1.21|0.0026
74017383|NCT04770753|147586443|SUPERIORITY||Difference in LS Mean|9.63|||<|0.0001|TWO_SIDED|95.0|7.8|11.46|||ANCOVA|||The estimates, 95% CIs, and 2-sided p-value are based on an ANCOVA model which includes average change from baseline in Hb concentrations from Week 12 through Week 24 as the dependent variable, treatment group as the independent variable, and baseline Hb concentration and the randomization stratification factors as covariates.||11.46|7.80|<0.0001
74017384|NCT02775851|147586465|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial|||We assumed a null pCR rate of 5% and powered the study assuming an alternative hypothesis of 25%. This single stage design had an alpha of 3.4% (i.e. probability of declaring the regimen warrants further study when the true CR is 5%) and a power of 90% (probability of declaring the regimen warrants further study when the true pCR is 25%) with 25 eligible participants.||||<0.001
74017385|NCT02775851|147586466|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial|||We assumed a null CR rate of 5% and powered the study assuming an alternative hypothesis of 20%. This single stage design had an alpha of 8.5% (i.e. probability of declaring the regimen warrants further study when the true CR is 5%) and a power of 82% (probability of declaring the regimen warrants further study when the true CR is 20%) with 21 eligible participants.||||<0.001
74046271|NCT00565812|147644893|SUPERIORITY_OR_OTHER||LS mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.98||0.537|TWO_SIDED|95.0|-1.32|2.54|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.54|-1.32|0.537
74046272|NCT00565812|147644893|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.98||0.988|TWO_SIDED|95.0|-1.9|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*(visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.93|-1.90|0.988
74046273|NCT00565812|147644893|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|1.11||0.962|TWO_SIDED|95.0|-2.12|2.22|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.22|-2.12|0.962
74096255|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.871||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.871
73880584|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.67||||0.045|TWO_SIDED|95.0|1.03|13.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.07|1.03|0.0450
74017386|NCT02066792|147586532|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.81|-0.21||two-sided|Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||At 3 month follow-up||-.21|-.81|<.001
74017387|NCT02066792|147586532|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.635|TWO_SIDED|95.0|-0.37|0.23||Two-sided|Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||.23|-.37|.635
74017388|NCT02066792|147586532|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.8|-0.18|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||||-.18|-.80|.002
74017389|NCT02066792|147586532|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.73|-0.14|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||-.14|-.73|.004
74096256|NCT03118570|147741802|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.113||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.113
74096257|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
74096258|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
74096259|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.984||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||0.984
74046274|NCT00565812|147644893|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.11||0.856|TWO_SIDED|95.0|-1.97|2.37|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.37|-1.97|0.856
74096260|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||< 0.001
74017390|NCT02066792|147586532|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.16||0.008|TWO_SIDED|95.0|-0.72|-0.11|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||-.11|-.72|.008
74046275|NCT00565812|147644893|SUPERIORITY_OR_OTHER||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|1.15||0.237|TWO_SIDED|95.0|-0.9|3.63|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.63|-0.90|0.237
74046276|NCT00565812|147644893|SUPERIORITY_OR_OTHER||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|1.15||0.475|TWO_SIDED|95.0|-1.44|3.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.09|-1.44|0.475
74046277|NCT00565812|147644894|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.57||0.938|TWO_SIDED|95.0|-1.07|1.16|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.16|-1.07|0.938
74046278|NCT00565812|147644894|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.56||0.906|TWO_SIDED|95.0|-1.04|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.17|-1.04|0.906
74046279|NCT00565812|147644894|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.65||0.726|TWO_SIDED|95.0|-1.5|1.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.04|-1.50|0.726
74096261|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.050
74017391|NCT03946670|147586605|SUPERIORITY|||||||0.769|||||||Cochran-Mantel-Haenszel|stratified by the randomization stratification factor IPSS-R category||||||0.769
74017392|NCT03946670|147586606|SUPERIORITY||Cox Proportional Hazard|0.749||||0.1022|TWO_SIDED|95.0|0.479|1.173|||Log Rank|stratified by the randomization stratification factor IPSS-R category||||1.173|0.479|0.1022
74017393|NCT03083886|147586652|SUPERIORITY||Risk Ratio (RR)|0.93||||0.04|TWO_SIDED|95.0|0.87|0.997|||GEE with log link and Poisson errors|||||.997|.87|.04
74017394|NCT03083886|147586652|SUPERIORITY||Risk Ratio (RR)|1.4|||<|0.001|TWO_SIDED|95.0|1.35|1.45|||GEE with log link and Poisson errors|||||1.45|1.35|<0.001
74017395|NCT03083886|147586653|SUPERIORITY||Risk Difference (RD)|-5.8|||<|0.001|TWO_SIDED|95.0|-7.7|-3.9|||GEE with identity link and normal errors|||||-3.9|-7.7|<0.001
74017396|NCT03083886|147586653|SUPERIORITY||Risk Difference (RD)|-4.3|||<|0.001|TWO_SIDED|95.0|-5.9|-2.6|||GEE with identity link and normal errors|||||-2.6|-5.9|<0.001
74017397|NCT03083886|147586654|SUPERIORITY||Risk Difference (RD)|-7.5|||<|0.001|TWO_SIDED|95.0|-9.4|-5.7|||GEE with identity link and normal errors|||||-5.7|-9.4|<0.001
74017398|NCT03083886|147586654|SUPERIORITY||Risk Difference (RD)|-6.7|||<|0.001|TWO_SIDED|95.0|-8.4|-5.0|||GEE with identity link and normal errors|||||-5.0|-8.4|<0.001
74017399|NCT03083886|147586655|SUPERIORITY||Risk Difference (RD)|4.7|||<|0.001|TWO_SIDED|95.0|2.6|6.8|||GEE with identity link and normal errors|||||6.8|2.6|<0.001
74017400|NCT03083886|147586655|SUPERIORITY||Risk Difference (RD)|6.0|||<|0.001|TWO_SIDED|95.0|4.1|7.9|||GEE with identity link and normal errors|||||7.9|4.1|<0.001
74017401|NCT03083886|147586656|SUPERIORITY||Risk Difference (RD)|6.8|||<|0.001|TWO_SIDED|95.0|5.0|8.7|||GEE with identity link and normal errors|||||8.7|5.0|<0.001
74017402|NCT03083886|147586656|SUPERIORITY||Risk Difference (RD)|6.7|||<|0.001|TWO_SIDED|95.0|5.0|8.4|||GEE with identity link and normal errors|||||8.4|5.0|<0.001
74017403|NCT04161495|147586659|NON_INFERIORITY|Non-inferiority would be established if the upper bound of the one-sided 97.5% CI was less than 4.|Mean difference|-2.3|||||TWO_SIDED|95.0|-3.49|-1.11||||||Hierarchical testing framework: used to control type I error for secondary OM analyses. Statistical testing of Arm A intra-participant comparison non-inferiority continued only when estimation of previous OM was statistically significant at 0.05 level. For Arm A intra-participant comparison, mean difference and 95% confidence interval (CI) were estimated by NB regression model in which treatment (BIVV001 prophylaxis vs historical prophylaxis vs historical prophylaxis) was treated as covariate.||-1.11|-3.49|
74017404|NCT04161495|147586661|SUPERIORITY|Superiority was declared if the upper bound of the one-sided 97.5% confidence interval was less than 1.|Rate ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.13|0.42|||Negative binomial regression mode|||Tested according to hierarchical testing procedure (only performed if the previous OM was statistically significant for the considered dosing regimen). For test about Arm A intra-participant comparison superiority, rate ratio and 95% CI were estimated using NB regression model in which treatment (BIVV001 prophylaxis vs historical prophylaxis) was treated as covariate.||0.42|0.13|<0.0001
74046280|NCT00565812|147644894|SUPERIORITY_OR_OTHER||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.64||0.681|TWO_SIDED|95.0|-1.52|1.0|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.00|-1.52|0.681
73880585|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0017|TWO_SIDED|95.0|2.1|24.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||24.66|2.10|0.0017
73880586|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3939|TWO_SIDED|95.0|0.47|6.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.97|0.47|0.3939
74017405|NCT04161495|147586663|SUPERIORITY||LS mean difference|-6.74|STANDARD_ERROR_OF_MEAN|1.71||0.0001|TWO_SIDED|95.0|-10.13|-3.36|||Unstructured covariance matrix|An unstructured covariance matrix within a participant was used.||Testing according to hierarchical testing procedure. Only performed if previous OM \[Annualized Bleeding Rate During the Efficacy Period in Prophylaxis Arm - Superiority Analysis\] was statistically significant for considered dosing regimen). Least square (LS) mean difference, standard error and 95% confidence interval were estimated by mixed-effect model with repeated measures (MMRM) using visit as fixed effect and Baseline Haem-A-QOL physical health score as covariate.||-3.36|-10.13|0.0001
74096262|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.857||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.857
73888068|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1||||0.7031|TWO_SIDED|95.0|-33.8|49.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.9|-33.8|0.7031
74017406|NCT04161495|147586664|SUPERIORITY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|0.67||0.0042|TWO_SIDED|95.0|-3.26|-0.63|||Unstructured covariance matrix|An unstructured covariance matrix within a participant was used.||Testing according to hierarchical testing procedure. Only performed if previous OM \[Change From Baseline in Haem-A-QOL Physical Health Score at Weeks 26 and 52: Prophylaxis Arm\] was statistically significant for considered dosing regimen). LS mean difference, standard error and 95% confidence interval were estimated by MMRM using visit as fixed effect and PROMIS Pain Intensity 3a score as covariate.||-0.63|-3.26|0.0042
74017407|NCT04161495|147586665|SUPERIORITY||LS mean difference|-1.54|STANDARD_ERROR_OF_MEAN|0.59||0.0101|TWO_SIDED|95.0|-2.7|-0.37||An unstructured covariance matrix within a participant was used.|Unstructured covariance matrix|||Testing according to hierarchical testing procedure (only performed if previous OM \[Change From Baseline in PROMIS Pain Intensity 3a First Item at Week 52: Prophylaxis Arm\] was statistically significant for considered dosing regimen). LS mean difference, standard error and 95% confidence interval were estimated by MMRM using visit as fixed effect and Baseline Haem-A-QOL physical health score as covariate.||-0.37|-2.70|0.0101
74017408|NCT02475655|147586738|SUPERIORITY|||||||0.67||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 5.||||0.67
74017409|NCT02475655|147586741|SUPERIORITY||Mean Difference (Net)|0.85||||0.18|TWO_SIDED|90.0|0.69|1.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to week 4/5.||1.04|0.69|0.18
74017410|NCT02475655|147586743|SUPERIORITY|||||||0.4||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 12.||||0.40
74017411|NCT02475655|147586747|SUPERIORITY||Mean Difference (Net)|1.31||||0.7|TWO_SIDED|90.0|-4.27|6.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 1/2.||6.90|-4.27|0.70
74017412|NCT02475655|147586747|SUPERIORITY||Mean Difference (Net)|1.61||||0.69|TWO_SIDED|90.0|-5.06|8.29||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 4/5.||8.29|-5.06|0.69
74017413|NCT02475655|147586747|SUPERIORITY||Mean Difference (Net)|6.35||||0.09|TWO_SIDED|90.0|0.16|12.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to 10/12.||12.5|0.16|0.09
74017414|NCT02475655|147586749|SUPERIORITY||Mean Difference (Net)|-0.02||||0.58|TWO_SIDED|90.0|-0.06|0.03||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 1/2.||0.03|-0.06|0.58
74017415|NCT02475655|147586749|SUPERIORITY||Mean Difference (Net)|-0.01||||0.79|TWO_SIDED|90.0|-0.06|0.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 4/5.||0.04|-0.06|0.79
74017416|NCT02475655|147586749|SUPERIORITY||Mean Difference (Net)|-0.07||||0.016|TWO_SIDED|90.0|-0.11|-0.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to 10/12.||-0.02|-0.11|0.016
74096263|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.001
73880587|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|2.06||||0.2869|TWO_SIDED|95.0|0.55|7.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.74|0.55|0.2869
73880588|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1817|TWO_SIDED|95.0|0.66|8.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.80|0.66|0.1817
73880589|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|11.41||||0.0256|TWO_SIDED|95.0|1.35|96.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||96.77|1.35|0.0256
74017417|NCT02475655|147586751|SUPERIORITY||Mean Difference (Net)|-679.0||||0.018|TWO_SIDED|90.0|-1146.0|-212.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 1/2.||-212|-1146|0.018
74017418|NCT02475655|147586751|SUPERIORITY||Mean Difference (Net)|-651.0||||0.021|TWO_SIDED|90.0|-1110.0|-192.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 4/5.||-192|-1110|0.021
74017419|NCT02475655|147586751|SUPERIORITY||Mean Difference (Net)|33.6||||0.91|TWO_SIDED|90.0|-461.0|528.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 10/12.||528|-461|0.91
74017420|NCT02475655|147586753|SUPERIORITY||Mean Difference (Net)|-0.13||||0.45|TWO_SIDED|90.0|-0.42|0.15||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 1/2.||0.15|-0.42|0.45
74017421|NCT02475655|147586753|SUPERIORITY||Mean Difference (Net)|-0.55||||0.005|TWO_SIDED|90.0|-0.87|-0.23||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 4/5.||-0.23|-0.87|0.005
74017422|NCT02475655|147586753|SUPERIORITY||Mean Difference (Net)|0.15||||0.75|TWO_SIDED|90.0|-0.65|0.95||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 10/12.||0.95|-0.65|0.75
74017423|NCT02475655|147586755|SUPERIORITY||Mean Difference (Net)|37754.0|||<|0.001|TWO_SIDED|90.0|19609.0|55898.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 1/2.||55898|19609|<0.001
74017424|NCT02475655|147586755|SUPERIORITY||Mean Difference (Net)|27832.0||||0.012|TWO_SIDED|90.0|9849.0|45815.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 4/5.||45815|9849|0.012
74017425|NCT02475655|147586755|SUPERIORITY||Mean Difference (Net)|5376.0||||0.52|TWO_SIDED|90.0|-8592.0|19344.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 10/12.||19344|-8592|0.52
74017426|NCT02475655|147586757|SUPERIORITY||Mean Difference (Net)|4.96||||0.05|TWO_SIDED|90.0|0.78|9.14||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 1/2.||9.14|0.78|0.05
74017427|NCT02475655|147586757|SUPERIORITY||Mean Difference (Net)|8.15|||<|0.001|TWO_SIDED|90.0|4.47|11.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 4/5.||11.8|4.47|<0.001
74017428|NCT02475655|147586757|SUPERIORITY||Mean Difference (Net)|3.95||||0.025|TWO_SIDED|90.0|1.08|6.81||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 10/12.||6.81|1.08|0.025
73880590|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|13.65||||0.0153|TWO_SIDED|95.0|1.65|112.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||112.8|1.65|0.0153
73888069|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0||||0.8507|TWO_SIDED|95.0|-45.8|37.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.8|-45.8|0.8507
74096264|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.079||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.079
73880591|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|21.76||||0.0042|TWO_SIDED|95.0|2.64|179.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||179.2|2.64|0.0042
73880592|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|35.75||||0.0008|TWO_SIDED|95.0|4.39|291.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||291.5|4.39|0.0008
74017429|NCT02475655|147586759|SUPERIORITY||Mean Difference (Net)|4.9||||0.02|TWO_SIDED|90.0|1.46|8.33||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 1/2.||8.33|1.46|0.020
74017430|NCT02475655|147586759|SUPERIORITY||Mean Difference (Net)|11.0||||0.004|TWO_SIDED|90.0|4.84|17.1||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 4/5.||17.1|4.84|0.004
74017431|NCT02475655|147586759|SUPERIORITY||Mean Difference (Net)|4.64||||0.043|TWO_SIDED|90.0|0.88|8.39||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 10/12.||8.39|0.88|0.043
74017432|NCT02475655|147586760|SUPERIORITY||Mean Difference (Net)|1.1||||0.56|TWO_SIDED|90.0|0.84|1.44||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to Week 10/12.||1.44|0.84|0.56
74017433|NCT02475655|147586760|SUPERIORITY||Mean Difference (Net)|1.37||||0.026|TWO_SIDED|90.0|1.09|1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from Week 4/5 to Week 10/12.||1.73|1.09|0.026
74017434|NCT02475655|147586761|SUPERIORITY||Mean Difference (Net)|0.89||||0.07|TWO_SIDED|90.0|0.8|0.99||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 4/5.||0.99|0.80|0.07
74017435|NCT02475655|147586761|SUPERIORITY||Mean Difference (Net)|0.95||||0.59|TWO_SIDED|90.0|0.8|1.12||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 12.||1.12|0.80|0.59
74017436|NCT02475655|147586761|SUPERIORITY||Mean Difference (Net)|1.06||||0.56|TWO_SIDED|90.0|0.9|1.24||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from Week 4/5 to Week 12.||1.24|0.90|0.56
74017437|NCT02475655|147586762|SUPERIORITY||Mean Difference (Net)|142.1||||0.007|TWO_SIDED|90.0|57.6|227.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 2.||227|57.6|0.007
74017438|NCT02475655|147586762|SUPERIORITY||Mean Difference (Net)|74.3||||0.14|TWO_SIDED|90.0|-8.23|156.7||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 5.||156.7|-8.23|0.14
74096265|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.912||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.912
73880593|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|6.45||||0.0967|TWO_SIDED|95.0|0.71|58.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||58.21|0.71|0.0967
73880594|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|8.3||||0.0564|TWO_SIDED|95.0|0.94|72.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||72.95|0.94|0.0564
74017439|NCT02475655|147586762|SUPERIORITY||Mean Difference (Net)|-38.9||||0.54|TWO_SIDED|90.0|-143.0|65.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 12.||65.5|-143|0.54
73880595|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|23.63||||0.003|TWO_SIDED|95.0|2.93|190.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||190.5|2.93|0.0030
74017440|NCT02475655|147586762|SUPERIORITY||Mean Difference (Net)|-112.0||||0.12|TWO_SIDED|90.0|-231.0|5.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|There is no difference between the two arms in the change in CD4+ T cell counts from Week 5 to Week 12.||5.90|-231|0.12
74017441|NCT02475655|147586764|SUPERIORITY||Risk Ratio (RR)|0.98||||0.94|TWO_SIDED|90.0|0.65|1.49||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 5.||1.49|0.65|0.94
74017442|NCT02475655|147586764|SUPERIORITY||Risk Ratio (RR)|0.74||||0.46|TWO_SIDED|90.0|0.37|1.46||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 12.||1.46|0.37|0.46
74017443|NCT02475655|147586764|SUPERIORITY||Risk Ratio (RR)|0.83||||0.59|TWO_SIDED|90.0|0.46|1.48||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Week 5 to Week 12.||1.48|0.46|0.59
74017444|NCT02475655|147586765|SUPERIORITY||Mean Difference (Net)|0.88||||0.11|TWO_SIDED|90.0|0.76|1.01||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 5.||1.01|0.76|0.11
74017445|NCT02475655|147586765|SUPERIORITY||Mean Difference (Net)|0.92||||0.71|TWO_SIDED|90.0|0.64|1.33||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 12.||1.33|0.64|0.71
74017446|NCT02475655|147586766|SUPERIORITY||Mean Difference (Net)|1.27||||0.3|TWO_SIDED|90.0|0.87|1.86||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 5.||1.86|0.87|0.30
74046281|NCT00565812|147644895|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.58||0.9|TWO_SIDED|95.0|-1.07|1.21|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.21|-1.07|0.900
74017447|NCT02475655|147586766|SUPERIORITY||Mean Difference (Net)|1.59||||0.46|TWO_SIDED|90.0|0.56|4.49||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 12.||4.49|0.56|0.46
74017448|NCT02475655|147586767|SUPERIORITY||Mean Difference (Net)|1.29||||0.24|TWO_SIDED|90.0|0.9|1.84||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 5.||1.84|0.90|0.24
74046282|NCT00565812|147644895|SUPERIORITY_OR_OTHER||LS mean difference|0.36|STANDARD_ERROR_OF_MEAN|0.58||0.528|TWO_SIDED|95.0|-0.77|1.5|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.50|-0.77|0.528
74046283|NCT00565812|147644895|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.62||0.647|TWO_SIDED|95.0|-1.51|0.94|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.94|-1.51|0.647
74096266|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.054||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.054
74046284|NCT00565812|147644895|SUPERIORITY_OR_OTHER||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.62||0.841|TWO_SIDED|95.0|-1.34|1.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.09|-1.34|0.841
74046285|NCT00565812|147644896|SUPERIORITY_OR_OTHER||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.59||0.587|TWO_SIDED|95.0|-0.84|1.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.48|-0.84|0.587
74046286|NCT00565812|147644896|SUPERIORITY_OR_OTHER||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.58||0.687|TWO_SIDED|95.0|-0.91|1.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.38|-0.91|0.687
74046287|NCT00565812|147644896|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.65||0.677|TWO_SIDED|95.0|-1.56|1.01|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.01|-1.56|0.677
74046288|NCT00565812|147644896|SUPERIORITY_OR_OTHER||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.65||0.469|TWO_SIDED|95.0|-0.8|1.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.74|-0.80|0.469
74096267|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.95||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.950
74096268|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.555||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.555
74096269|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.221||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.221
74096270|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.393||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.393
74096271|NCT03118570|147741803|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.385||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.385
74096272|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
73880596|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|9.72||||0.0384|TWO_SIDED|95.0|1.13|83.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||83.68|1.13|0.0384
73888070|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.3||||0.0381|TWO_SIDED|95.0|-121.2|-3.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.5|-121.2|0.0381
74017449|NCT02475655|147586767|SUPERIORITY||Mean Difference (Net)|1.19||||0.46|TWO_SIDED|90.0|0.81|1.74||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 12.||1.74|0.81|0.46
74017450|NCT02475655|147586772|SUPERIORITY||Mean Difference (Net)|1.15||||0.56|TWO_SIDED|90.0|0.77|1.72||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 5.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|1.72|0.77|0.56
74096273|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
74096274|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
74096275|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.003
74046289|NCT00565812|147644897|SUPERIORITY_OR_OTHER||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.48||0.632|TWO_SIDED|95.0|-0.71|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.17|-0.71|0.632
74046290|NCT00565812|147644897|SUPERIORITY_OR_OTHER||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.48||0.308|TWO_SIDED|95.0|-0.45|1.42|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.42|-0.45|0.308
74046291|NCT00565812|147644897|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.54||0.615|TWO_SIDED|95.0|-1.33|0.79|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.79|-1.33|0.615
74046292|NCT00565812|147644897|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.53||0.425|TWO_SIDED|95.0|-1.48|0.62|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.62|-1.48|0.425
74046293|NCT00565812|147644898|SUPERIORITY_OR_OTHER||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|0.54||0.214|TWO_SIDED|95.0|-0.39|1.72|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.72|-0.39|0.214
74046294|NCT00565812|147644898|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.53||0.98|TWO_SIDED|95.0|-1.06|1.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.03|-1.06|0.980
74046295|NCT00565812|147644898|SUPERIORITY_OR_OTHER||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.59||0.575|TWO_SIDED|95.0|-0.83|1.49|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.49|-0.83|0.575
74046296|NCT00565812|147644898|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.59||0.986|TWO_SIDED|95.0|-1.16|1.14|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.14|-1.16|0.986
74046297|NCT00565812|147644899|SUPERIORITY_OR_OTHER||LS mean difference|1.33|STANDARD_ERROR_OF_MEAN|0.61||0.03|TWO_SIDED|95.0|0.13|2.52|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.52|0.13|0.030
74046298|NCT00565812|147644899|SUPERIORITY_OR_OTHER||LS mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.6||0.48|TWO_SIDED|95.0|-0.76|1.61|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-0.76|0.480
74017451|NCT02475655|147586772|SUPERIORITY||Mean Difference (Net)|0.97||||0.95|TWO_SIDED|90.0|0.47|2.01||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 12.||2.01|0.47|0.95
74017452|NCT02475655|147586773|SUPERIORITY||Mean Difference (Net)|1.34||||0.002|TWO_SIDED|90.0|1.15|1.56||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 5.||1.56|1.15|0.002
74017453|NCT02475655|147586773|SUPERIORITY||Mean Difference (Net)|1.07||||0.6|TWO_SIDED|90.0|0.86|1.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 12.||1.34|0.86|0.60
74046299|NCT00565812|147644899|SUPERIORITY_OR_OTHER||LS mean difference|1.01|STANDARD_ERROR_OF_MEAN|0.67||0.132|TWO_SIDED|95.0|-0.3|2.32|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.32|-0.30|0.132
74017454|NCT02475655|147586774|SUPERIORITY||Mean Difference (Net)|0.94||||0.4|TWO_SIDED|90.0|0.82|1.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 5.||1.07|0.82|0.40
74017455|NCT02475655|147586774|SUPERIORITY||Mean Difference (Net)|1.03||||0.82|TWO_SIDED|90.0|0.83|1.27||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 12.||1.27|0.83|0.82
74017456|NCT02475655|147586775|SUPERIORITY||Mean Difference (Net)|1.5||||0.028|TWO_SIDED|90.0|1.11|2.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 5.||2.02|1.11|0.028
74017457|NCT02475655|147586775|SUPERIORITY||Mean Difference (Net)|2.04||||0.21|TWO_SIDED|90.0|0.79|5.25||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 12.||5.25|0.79|0.21
74017458|NCT02475655|147586776|SUPERIORITY||Mean Difference (Net)|1.39||||0.031|TWO_SIDED|90.0|1.08|1.79||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 5.||1.79|1.08|0.031
74017459|NCT02475655|147586776|SUPERIORITY||Mean Difference (Net)|0.96||||0.93|TWO_SIDED|90.0|0.46|2.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 12.||2.02|0.46|0.93
74017460|NCT02475655|147586777|SUPERIORITY||Mean Difference (Net)|1.57||||0.43|TWO_SIDED|90.0|0.61|4.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 5.||4.05|0.61|0.43
74017461|NCT02475655|147586777|SUPERIORITY||Mean Difference (Net)|0.68||||0.41|TWO_SIDED|90.0|0.3|1.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 12.||1.50|0.30|0.41
74017462|NCT02475655|147586778|SUPERIORITY||Mean Difference (Net)|-0.34||||0.038|TWO_SIDED|90.0|-0.61|-0.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 5.||-0.07|-0.61|0.038
74017463|NCT02475655|147586778|SUPERIORITY||Mean Difference (Net)|0.27||||0.07|TWO_SIDED|90.0|0.03|0.51||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 12.||0.51|0.03|0.07
74017464|NCT02475655|147586779|SUPERIORITY||Mean Difference (Net)|-0.88||||0.05|TWO_SIDED|90.0|-1.62|-0.13||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.||-0.13|-1.62|0.05
74017465|NCT02475655|147586779|SUPERIORITY||Mean Difference (Net)|0.86||||0.16|TWO_SIDED|90.0|-0.16|1.88||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.||1.88|-0.16|0.16
74046300|NCT00565812|147644899|SUPERIORITY_OR_OTHER||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|0.66||0.117|TWO_SIDED|95.0|-0.26|2.34|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.34|-0.26|0.117
74017466|NCT02475655|147586780|SUPERIORITY||Mean Difference (Net)|-1.71|||<|0.001|TWO_SIDED|90.0|-2.46|-0.97||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 5.||-0.97|-2.46|<0.001
74017467|NCT02475655|147586780|SUPERIORITY||Mean Difference (Net)|0.16||||0.68|TWO_SIDED|90.0|-0.5|0.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 12.||0.82|-0.50|0.68
74046301|NCT00565812|147644900|SUPERIORITY_OR_OTHER||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|0.71||0.133|TWO_SIDED|95.0|-0.32|2.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-0.32|0.133
74046302|NCT00565812|147644900|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.7||0.524|TWO_SIDED|95.0|-0.93|1.82|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.82|-0.93|0.524
74017468|NCT02475655|147586781|SUPERIORITY||Mean Difference (Net)|-0.01||||0.98|TWO_SIDED|90.0|-0.7|0.69||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 5.||0.69|-0.70|0.98
74017469|NCT02475655|147586781|SUPERIORITY||Mean Difference (Net)|-0.16||||0.79|TWO_SIDED|90.0|-1.13|0.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 12.||0.82|-1.13|0.79
74017470|NCT02475655|147586782|SUPERIORITY||Mean Difference (Net)|3.49||||0.001|TWO_SIDED|90.0|1.75|5.22||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 5.||5.22|1.75|0.001
74017471|NCT02475655|147586782|SUPERIORITY||Mean Difference (Net)|-1.3||||0.28|TWO_SIDED|90.0|-3.28|0.68||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 12.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|0.68|-3.28|0.28
74017472|NCT02475655|147586783|SUPERIORITY||Mean Difference (Net)|6.54|||<|0.001|TWO_SIDED|90.0|3.76|9.31||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 5.||9.31|3.76|<0.001
74017473|NCT02475655|147586783|SUPERIORITY||Mean Difference (Net)|-0.19||||0.92|TWO_SIDED|90.0|-3.56|3.18||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 12.||3.18|-3.56|0.92
74017474|NCT02475655|147586784|SUPERIORITY||Mean Difference (Net)|-0.07||||0.82|TWO_SIDED|90.0|-0.61|0.47||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 5.||0.47|-0.61|0.82
74017475|NCT02475655|147586784|SUPERIORITY||Mean Difference (Net)|0.76||||0.033|TWO_SIDED|90.0|0.18|1.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 12.||1.34|0.18|0.033
74017476|NCT02475655|147586785|SUPERIORITY||Mean Difference (Net)|0.01||||0.98|TWO_SIDED|90.0|-0.53|0.55||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 5.||0.55|-0.53|0.98
74017477|NCT02475655|147586785|SUPERIORITY||Mean Difference (Net)|0.55||||0.37|TWO_SIDED|90.0|-0.46|1.57||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 12.||1.57|-0.46|0.37
74017478|NCT02475655|147586786|SUPERIORITY||Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|90.0|-4.72|-1.87||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 5.||-1.87|-4.72|<0.001
74017479|NCT02475655|147586786|SUPERIORITY||Mean Difference (Net)|-0.73||||0.09|TWO_SIDED|90.0|-1.42|-0.03||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 12.||-0.03|-1.42|0.09
74017480|NCT02475655|147586787|SUPERIORITY||Mean Difference (Net)|-5.4|||<|0.001|TWO_SIDED|90.0|-7.29|-3.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 5.||-3.50|-7.29|<0.001
74017481|NCT02475655|147586787|SUPERIORITY||Mean Difference (Net)|-1.23||||0.11|TWO_SIDED|90.0|-2.51|0.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 12.||0.05|-2.51|0.11
74017482|NCT02475655|147586788|SUPERIORITY||Mean Difference (Net)|-1.54||||0.26|TWO_SIDED|90.0|-3.78|0.7||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 5.||0.70|-3.78|0.26
74017483|NCT02475655|147586788|SUPERIORITY||Mean Difference (Net)|-0.39||||0.74|TWO_SIDED|90.0|-2.41|1.62||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 12.||1.62|-2.41|0.74
74017484|NCT02475655|147586789|SUPERIORITY||Mean Difference (Net)|0.55||||0.71|TWO_SIDED|90.0|-1.9|3.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 5.||3.00|-1.90|0.71
74017485|NCT02475655|147586789|SUPERIORITY||Mean Difference (Net)|0.31||||0.83|TWO_SIDED|90.0|-2.15|2.78||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 12.||2.78|-2.15|0.83
74017486|NCT02475655|147586790|SUPERIORITY||Mean Difference (Net)|-1.33||||0.01|TWO_SIDED|90.0|-2.16|-0.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 5.||-0.50|-2.16|0.010
74017487|NCT02475655|147586790|SUPERIORITY||Mean Difference (Net)|-0.17||||0.74|TWO_SIDED|90.0|-1.02|0.68||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 12.||0.68|-1.02|0.74
74017488|NCT02475655|147586791|SUPERIORITY||Mean Difference (Net)|-3.24||||0.008|TWO_SIDED|90.0|-5.22|-1.27||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.||-1.27|-5.22|0.008
74017489|NCT02475655|147586791|SUPERIORITY||Median Difference (Net)|-0.17||||0.9|TWO_SIDED|90.0|-2.38|2.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.||2.05|-2.38|0.90
74017490|NCT02475655|147586794|SUPERIORITY||Mean Difference (Net)|1.39||||0.47|TWO_SIDED|90.0|-1.83|4.61||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 5.||4.61|-1.83|0.47
74017491|NCT02475655|147586794|SUPERIORITY||Mean Difference (Net)|2.21||||0.22|TWO_SIDED|90.0|-0.77|5.18||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 12.||5.18|-0.77|0.22
73880597|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|13.65||||0.0153|TWO_SIDED|95.0|1.65|112.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||112.9|1.65|0.0153
73880598|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|30.55||||0.0015|TWO_SIDED|95.0|3.72|250.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||250.6|3.72|0.0015
73880599|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|35.99||||0.0008|TWO_SIDED|95.0|4.41|293.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||293.5|4.41|0.0008
73880600|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|12.67||||0.0192|TWO_SIDED|95.0|1.51|106.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||106.1|1.51|0.0192
73880601|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|16.92||||0.0089|TWO_SIDED|95.0|2.03|141.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||141.0|2.03|0.0089
73880602|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|24.96||||0.0025|TWO_SIDED|95.0|3.09|201.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||201.6|3.09|0.0025
73880603|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.03||||0.091|TWO_SIDED|95.0|0.84|10.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.94|0.84|0.0910
74017492|NCT02475655|147586795|SUPERIORITY||Mean Difference (Net)|-4.34||||0.28|TWO_SIDED|90.0|-11.0|2.35||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 5.||2.35|-11.0|0.28
74017493|NCT02475655|147586795|SUPERIORITY||Mean Difference (Net)|-9.81||||0.019|TWO_SIDED|90.0|-16.6|-3.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 12.||-3.02|-16.6|0.019
74017494|NCT02475655|147586796|SUPERIORITY||Mean Difference (Net)|-0.81||||0.55|TWO_SIDED|90.0|-3.02|1.41||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 5.||1.41|-3.02|0.55
74017495|NCT02475655|147586796|SUPERIORITY||Mean Difference (Net)|-1.7||||0.09|TWO_SIDED|90.0|-3.36|-0.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 12.||-0.04|-3.36|0.09
74096276|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.050
73880604|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0296|TWO_SIDED|95.0|1.15|13.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.67|1.15|0.0296
73880605|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|8.23||||0.0009|TWO_SIDED|95.0|2.38|28.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||28.44|2.38|0.0009
73880606|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|8.54||||0.0007|TWO_SIDED|95.0|2.46|29.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||29.63|2.46|0.0007
73880607|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4152|TWO_SIDED|95.0|0.45|6.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.86|0.45|0.4152
73880608|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.29||||0.07|TWO_SIDED|95.0|0.91|11.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.93|0.91|0.0700
73880609|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|5.83||||0.0048|TWO_SIDED|95.0|1.71|19.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||19.84|1.71|0.0048
74017496|NCT02475655|147586797|SUPERIORITY||Mean Difference (Net)|-1.47||||0.15|TWO_SIDED|90.0|-3.17|0.23||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 5.||0.23|-3.17|0.15
74017497|NCT02475655|147586797|SUPERIORITY||Mean Difference (Net)|-1.62||||0.37|TWO_SIDED|90.0|-4.59|1.35||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 12.||1.35|-4.59|0.37
74017498|NCT02475655|147586798|SUPERIORITY||Mean Difference (Net)|-0.86||||0.39|TWO_SIDED|90.0|-2.51|0.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 5.||0.80|-2.51|0.39
74017499|NCT02475655|147586798|SUPERIORITY||Mean Difference (Net)|-0.7||||0.54|TWO_SIDED|90.0|-2.59|1.19||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 12.||1.19|-2.59|0.54
74017500|NCT02475655|147586799|SUPERIORITY||Mean Difference (Net)|-6.02||||0.1|TWO_SIDED|90.0|-12.0|-0.06||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 5.||-0.06|-12.0|0.10
74017501|NCT02475655|147586799|SUPERIORITY||Mean Difference (Net)|-6.39||||0.026|TWO_SIDED|90.0|-11.1|-1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 12.||-1.73|-11.1|0.026
74017502|NCT02475655|147586800|SUPERIORITY||Mean Difference (Net)|0.28||||0.95|TWO_SIDED|90.0|-7.26|7.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 5.||7.82|-7.26|0.95
74017503|NCT02475655|147586800|SUPERIORITY||Mean Difference (Net)|-4.1||||0.43|TWO_SIDED|90.0|-12.6|4.45||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 12.||4.45|-12.6|0.43
74017504|NCT02475655|147586801|SUPERIORITY||Mean Difference (Net)|1.23||||0.74|TWO_SIDED|90.0|-5.08|7.54||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 5.||7.54|-5.08|0.74
74017505|NCT02475655|147586801|SUPERIORITY||Mean Difference (Net)|3.76||||0.42|TWO_SIDED|90.0|-3.94|11.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 12.||11.5|-3.94|0.42
74017506|NCT02475655|147586802|SUPERIORITY||Mean Difference (Net)|-0.63||||0.66|TWO_SIDED|90.0|-2.99|1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 5.||1.73|-2.99|0.66
74017507|NCT02475655|147586802|SUPERIORITY||Mean Difference (Net)|-1.56||||0.27|TWO_SIDED|90.0|-3.93|0.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 12.||0.80|-3.93|0.27
74017508|NCT02475655|147586803|SUPERIORITY||Mean Difference (Net)|-7.1||||0.013|TWO_SIDED|90.0|-11.7|-2.46||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 5.||-2.46|-11.7|0.013
74017509|NCT02475655|147586803|SUPERIORITY||Mean Difference (Net)|-1.49||||0.7|TWO_SIDED|90.0|-8.06|5.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 12.||5.07|-8.06|0.70
74017510|NCT02475655|147586804|SUPERIORITY||Mean Difference (Net)|0.01||||0.79|TWO_SIDED|90.0|-0.05|0.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 5.||0.07|-0.05|0.79
74017511|NCT02475655|147586804|SUPERIORITY||Mean Difference (Net)|0.01||||0.91|TWO_SIDED|90.0|-0.07|0.08||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 12.||0.08|-0.07|0.91
74096277|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.006
73880610|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1497|TWO_SIDED|95.0|0.72|8.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.23|0.72|0.1497
74046303|NCT00565812|147644900|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.78||0.743|TWO_SIDED|95.0|-1.27|1.78|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-1.27|0.743
74046304|NCT00565812|147644900|SUPERIORITY_OR_OTHER||LS mean difference|0.78|STANDARD_ERROR_OF_MEAN|0.77||0.31|TWO_SIDED|95.0|-0.73|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.73|0.310
74046305|NCT00565812|147644901|SUPERIORITY_OR_OTHER||LS mean difference|1.17|STANDARD_ERROR_OF_MEAN|0.62||0.058|TWO_SIDED|95.0|-0.04|2.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.38|-0.04|0.058
74046306|NCT00565812|147644901|SUPERIORITY_OR_OTHER||LS mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.61||0.213|TWO_SIDED|95.0|-0.44|1.96|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.96|-0.44|0.213
74046307|NCT00565812|147644901|SUPERIORITY_OR_OTHER||LS mean difference|0.98|STANDARD_ERROR_OF_MEAN|0.67||0.143|TWO_SIDED|95.0|-0.33|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.33|0.143
74046308|NCT00565812|147644901|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.67||0.45|TWO_SIDED|95.0|-0.8|1.81|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.81|-0.80|0.450
74096278|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.519||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.519
73888071|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|64.0||||0.0318|TWO_SIDED|95.0|5.7|122.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||122.3|5.7|0.0318
74046309|NCT00565812|147644902|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.701|TWO_SIDED|95.0|-1.19|0.8|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.80|-1.19|0.701
74046310|NCT00565812|147644902|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.5||0.764|TWO_SIDED|95.0|-0.84|1.14|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.14|-0.84|0.764
74046311|NCT00565812|147644902|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.57||0.228|TWO_SIDED|95.0|-1.8|0.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.43|-1.80|0.228
74046312|NCT00565812|147644902|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.56||0.514|TWO_SIDED|95.0|-1.47|0.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.74|-1.47|0.514
74096279|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.226||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.226
74096280|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.190
74096281|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.388||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.388
74096282|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.109||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.109
74096283|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.204||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.204
74096284|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.119||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.119
74096285|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.925||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.925
74096286|NCT03118570|147741804|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.204||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.204
74096287|NCT03118570|147741805|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.588||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.588
74096288|NCT03118570|147741805|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.697||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.697
74096289|NCT03118570|147741805|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.283||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.283
74096290|NCT03118570|147741805|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.354||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.354
74096291|NCT03118570|147741805|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.43||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.430
74096292|NCT03118570|147741805|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.091||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.091
74096293|NCT03118570|147741806|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.527||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.527
74096294|NCT03118570|147741806|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.738||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.738
74096295|NCT03118570|147741806|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.465||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.465
74096296|NCT03118570|147741806|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.068||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.068
74096297|NCT03118570|147741806|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.328||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.328
74096298|NCT03118570|147741806|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.277||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.277
74096299|NCT03118570|147741807|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.092||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.092
74096300|NCT03118570|147741807|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.31||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.310
74096301|NCT03118570|147741807|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.304||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.304
74096302|NCT03118570|147741807|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.155||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.155
74096303|NCT03118570|147741807|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.392||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.392
74017512|NCT02475655|147586805|SUPERIORITY||Mean Difference (Net)|-2.85||||0.43|TWO_SIDED|90.0|-8.82|3.12||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 5.||3.12|-8.82|0.43
74017513|NCT02475655|147586805|SUPERIORITY||Mean Difference (Net)|0.03||||0.99|TWO_SIDED|90.0|-6.53|6.6||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 12.||6.60|-6.53|0.99
74017514|NCT02475655|147586806|SUPERIORITY||Median Difference (Net)|1.88||||0.007|TWO_SIDED|90.0|1.29|2.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 5.||2.73|1.29|0.007
74017515|NCT02475655|147586806|SUPERIORITY||Mean Difference (Net)|1.31||||0.23|TWO_SIDED|90.0|0.9|1.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 12.||1.90|0.90|0.23
74017516|NCT02475655|147586807|SUPERIORITY||Mean Difference (Net)|1.22||||0.32|TWO_SIDED|90.0|0.87|1.72||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 5.||1.72|0.87|0.32
74017517|NCT02475655|147586807|SUPERIORITY||Mean Difference (Net)|1.03||||0.91|TWO_SIDED|90.0|0.68|1.56||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 12.||1.56|0.68|0.91
74046313|NCT00565812|147644903|SUPERIORITY_OR_OTHER||LS mean difference|1.42|STANDARD_ERROR_OF_MEAN|0.62||0.023|TWO_SIDED|95.0|0.19|2.65|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.65|0.19|0.023
74046314|NCT00565812|147644903|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.62||0.391|TWO_SIDED|95.0|-0.68|1.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.75|-0.68|0.391
74046315|NCT00565812|147644903|SUPERIORITY_OR_OTHER||LS mean difference|1.02|STANDARD_ERROR_OF_MEAN|0.69||0.142|TWO_SIDED|95.0|-0.34|2.37|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.37|-0.34|0.142
74096304|NCT03118570|147741807|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.464||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.464
74017518|NCT02475655|147586808|SUPERIORITY|||||||0.4||||||Not adjusted for multiple comparisons. Two-sided 10% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5).||||0.40
74046316|NCT00565812|147644903|SUPERIORITY_OR_OTHER||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|0.68||0.204|TWO_SIDED|95.0|-0.47|2.21|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.21|-0.47|0.204
74046317|NCT00565812|147644910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.952||||0.875|TWO_SIDED|95.0|0.516|1.756|||Regression, Logistic|||Month 12; Odds ratio (OR), 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.756|0.516|0.875
74096305|NCT03118570|147741808|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.15||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.150
74096306|NCT03118570|147741808|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.468||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.468
74017519|NCT02475655|147586808|SUPERIORITY|||||||0.87||||||Not adjusted for multiple comparisons. Two-sided 10% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any post-treatment time point (ever shedding at weeks 10 or 12).||||0.87
74017520|NCT02475655|147586812|SUPERIORITY||Mean Difference (Net)|0.53||||0.4|TWO_SIDED|90.0|0.15|1.88||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 5.||1.88|0.15|0.40
74017521|NCT02475655|147586812|SUPERIORITY||Mean Difference (Net)|0.92||||0.93|TWO_SIDED|90.0|0.2|4.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 12.||4.34|0.20|0.93
74017522|NCT03545906|147586828|SUPERIORITY||Mean Difference (Net)|1.0||||0.075|TWO_SIDED||||||t-test, 2 sided|||||||.075
74017523|NCT03545906|147586829|SUPERIORITY||Mean Difference (Net)|1.3||||0.018|TWO_SIDED||||||t-test, 2 sided|||||||.018
74017524|NCT03545906|147586830|SUPERIORITY||Mean Difference (Net)|1.2||||0.039|TWO_SIDED||||||t-test, 2 sided|||||||.039
74046318|NCT00565812|147644910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.273||||0.406|TWO_SIDED|95.0|0.721|2.247|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||2.247|0.721|0.406
74046319|NCT00565812|147644910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.787||||0.406|TWO_SIDED|95.0|0.448|1.384|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.384|0.448|0.406
74046320|NCT00565812|147644910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.154||||0.591|TWO_SIDED|95.0|0.685|1.942|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.942|0.685|0.591
74046321|NCT00565812|147644911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.704||||0.168|TWO_SIDED|95.0|0.428|1.16|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.160|0.428|0.168
74046322|NCT00565812|147644911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.893||||0.634|TWO_SIDED|95.0|0.56|1.423|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.423|0.560|0.634
74046323|NCT00565812|147644911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.583||||0.032|TWO_SIDED|95.0|0.356|0.955|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||0.955|0.356|0.032
74096307|NCT03118570|147741808|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.8||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.800
74017525|NCT03545906|147586831|SUPERIORITY||Mean Difference (Net)|0.7||||0.265|TWO_SIDED||||||t-test, 2 sided|||||||.265
74017526|NCT00353418|147586832|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6119||95.0|0.68|1.93|||Cochran-Mantel-Haenszel|||"Sample sizes of 133 and 267 patients for RBV 800 mg daily and RBV 1000 or 1200 mg daily, respectively, provided the following probabilities of detecting the specified differences in SVR with a 0.05 level two-sided chi-square test of significance:~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.40; Probability - 0.49~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.45; Probability - 0.83"||1.93|0.68|0.6119
74046324|NCT00565812|147644911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.774||||0.276|TWO_SIDED|95.0|0.489|1.227|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.227|0.489|0.276
74046325|NCT00565812|147644912|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.709|TWO_SIDED|95.0|-0.21|0.14|||ANCOVA|||LS Mean, 95 percent CI and P-values were obtained from an analysis of covariance (ANCOVA) model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.||0.14|-0.21|0.709
74046326|NCT00565812|147644912|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.798|TWO_SIDED|95.0|-0.15|0.2|||ANCOVA|||LS-Mean, 95 percent CI and P-values were obtained from an ANCOVA model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.||0.20|-0.15|0.798
74046327|NCT00565812|147644913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||0.81|TWO_SIDED|95.0|0.797|1.337|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.||1.337|0.797|0.810
74096308|NCT03118570|147741808|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.563||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.563
74017527|NCT03244033|147586891|SUPERIORITY||Odds Ratio (OR)|0.97||||0.91|TWO_SIDED|96.0|0.57|1.64|||Mixed Models Analysis|Adjusted for site (p\<.001) and for whether physician contextualized plan (AOR 2.14, p=.001), and random effects of physician and patient.||Logistic mixed effects regression modeling likelihood of red flag improved/resolved (vs. not) during outcome period with fixed effects of intervention, site, and whether contextual factor was incorporated into care plan, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||1.64|.57|.91
74017528|NCT03244033|147586892|SUPERIORITY||Odds Ratio (OR)|2.09||||0.02|TWO_SIDED|95.0|1.13|3.86|||Mixed Models Analysis|Adjusted for site, source of red flag, visible/concealed recorder, and random effects of physician and patient.|OR\>1 indicates greater likelihood in intervention group vs. control.|Logistic mixed effects regression modeling likelihood of provider probing red flag (vs. not) during visit with fixed effects of intervention, site, \\whether red flag was select on pre-visit questionnaire, and whether audiorecorder was visible to provider, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||3.86|1.13|0.02
74017529|NCT03244033|147586893|SUPERIORITY||Odds Ratio (OR)|2.67||||0.006|TWO_SIDED|95.0|1.32|5.41|||Mixed Models Analysis|Adjusted for site, source of factor, recorder visible/concealed, and random effects of physician and patient.|OR \> 1 indicates greater likelihood in intervention group vs. control.|Logistic mixed effects regression modeling likelihood of provider incorporating contextual factor into care plan (vs. not) at visit with fixed effects of intervention, site, whether red flag was select on pre-visit questionnaire, whether audiorecorder was visible to provider, whether factor was identified by provider probe, whether factor was revealed by patient, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||5.41|1.32|.006
74017530|NCT00662792|147586910|SUPERIORITY||Difference of adjusted means|0.13|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.102|0.158|||ANOVA|Analysis of variance with terms for centre, patient with centre, treatment, and period.|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. salmeterol (Salm50DPI) for FEV1 AUC0-12||0.158|0.102|<0.0001
74017531|NCT00662792|147586910|SUPERIORITY||Difference of adjusted means|0.07|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.042|0.097|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs Tiotropium (Tio18GEL) for FEV1 AUC0- 12||0.097|0.042|<.0001
74017532|NCT00662792|147586910|OTHER||Difference of adjusted means|-0.024|STANDARD_ERROR_OF_MEAN|0.014||0.0914|TWO_SIDED|95.0|-0.052|0.004|||ANOVA|Analysis of variance with terms for centre, patient with centre, treatment, and period. α = 0.025 one-sided|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||0.004|-0.052|0.0914
74046328|NCT00565812|147644913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.068||||0.62|TWO_SIDED|95.0|0.824|1.383|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.||1.383|0.824|0.620
74046329|NCT00565812|147644914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.745||||0.047|TWO_SIDED|95.0|0.557|0.997|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||0.997|0.557|0.047
74017533|NCT00662792|147586911|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Difference of adjusted means|0.064|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.036|0.093|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Non-Inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) for FEV1AUC12-24||0.093|0.036|<.0001
74046330|NCT00565812|147644914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.864||||0.317|TWO_SIDED|95.0|0.65|1.15|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.150|0.650|0.317
74096309|NCT03118570|147741808|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.839||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.839
74096310|NCT03118570|147741808|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.186||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.186
74046331|NCT00565812|147644915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.043||||0.881|TWO_SIDED|95.0|0.602|1.806|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.806|0.602|0.881
74096311|NCT03118570|147741809|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.278||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.278
74096312|NCT03118570|147741809|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.292||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.292
74017534|NCT00662792|147586911|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Difference of adjusted means|0.064|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.036|0.093|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of FEV1AUC12-24||0.093|0.036|<.0001
74017535|NCT00662792|147586911|OTHER||Difference of adjusted means|-0.057|STANDARD_ERROR_OF_MEAN|0.015||0.0001|TWO_SIDED|95.0|-0.086|-0.028|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||-0.028|-0.086|0.0001
74017536|NCT00662792|147586912|SUPERIORITY||Difference of adjusted means|0.134|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.102|0.166|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) of Peak FEV1||0.166|0.102|<.0001
74017537|NCT00662792|147586912|SUPERIORITY||Difference of adjusted means|0.066|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.034|0.098|||ANOVA|Analysis of with terms for centre, patient with centre, treatment, and period. α = 0.025 one-sided|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of PeakFEV1.||0.098|0.034|<.0001
74017538|NCT00662792|147586912|OTHER||Difference of adjusted means|-0.026|STANDARD_ERROR_OF_MEAN|0.016||0.1093|TWO_SIDED|95.0|-0.058|0.006|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S\_DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||0.006|-0.058|0.1093
74017539|NCT00662792|147586913|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Differences of adjusted means|0.058|STANDARD_ERROR_OF_MEAN|0.017||0.0008|TWO_SIDED|95.0|0.024|0.092|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) of trough FEV1||0.092|0.024|0.0008
74017540|NCT00662792|147586913|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as a delta of 0.050 L.|Difference of adjusted means|0.029|STANDARD_ERROR_OF_MEAN|0.017||0.0857|TWO_SIDED|95.0|-0.004|0.063|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of trough FEV1||0.063|-0.004|0.0857
74017541|NCT00662792|147586913|OTHER||Difference of adjusted means|-0.037|STANDARD_ERROR_OF_MEAN|0.017||0.0317|TWO_SIDED|95.0|-0.071|-0.003|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||-0.003|-0.071|0.0317
74017542|NCT00662792|147586914|SUPERIORITY||Difference of adjusted means|0.097|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.071|0.124|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. salmeterol (Salm50DPI) for FEV1 AUC0-24||0.124|0.071|<.0001
74017543|NCT00662792|147586914|SUPERIORITY||Difference of adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.041|0.093|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) for FEV1 AUC24||0.093|0.041|<.0001
74017544|NCT00662792|147586914|SUPERIORITY||Difference of adjusted means|-0.041|STANDARD_ERROR_OF_MEAN|0.014||0.0029|TWO_SIDED|95.0|-0.067|-0.014|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (T18GEL+S-DPI)|||-0.014|-0.067|0.0029
74017545|NCT00662792|147586915|SUPERIORITY||Difference of adjusted means|0.083|STANDARD_ERROR_OF_MEAN|0.025||0.001|TWO_SIDED|95.0|0.034|0.132|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Tio18GEL)|||0.132|0.034|0.0010
74017546|NCT00662792|147586915|SUPERIORITY||Difference of adjusted means|0.176|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.127|0.226|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.226|0.127|<.0001
74046332|NCT00565812|147644915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.186||||0.525|TWO_SIDED|95.0|0.701|2.009|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||2.009|0.701|0.525
74017547|NCT00662792|147586915|SUPERIORITY||Difference of adjusted means|-0.045|STANDARD_ERROR_OF_MEAN|0.025||0.0757|TWO_SIDED|95.0|-0.095|0.005|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.005|-0.095|0.0757
74017548|NCT00662792|147586916|SUPERIORITY||Difference of adjusted means|0.085|STANDARD_ERROR_OF_MEAN|0.027||0.0015|TWO_SIDED|95.0|0.033|0.137|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.137|0.033|0.0015
74017549|NCT00662792|147586916|SUPERIORITY||Difference of adjusted means|0.118|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.066|0.171|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.171|0.066|<.0001
73888072|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|15.2||||0.6095|TWO_SIDED|95.0|-43.6|74.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||74.1|-43.6|0.6095
74017550|NCT00662792|147586916|SUPERIORITY||Difference of adjusted means|-0.085|STANDARD_ERROR_OF_MEAN|0.027||0.0017|TWO_SIDED|95.0|-0.138|-0.032|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.032|-0.138|0.0017
74017551|NCT00662792|147586917|SUPERIORITY||Difference of adjusted means|0.084|STANDARD_ERROR_OF_MEAN|0.024||0.0005|TWO_SIDED|95.0|0.037|0.131|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.131|0.037|0.0005
74017552|NCT00662792|147586917|SUPERIORITY||Difference of adjusted means|0.147|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.194|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.194|0.100|<.0001
74017553|NCT00662792|147586917|SUPERIORITY||Difference of adjusted means|-0.065|STANDARD_ERROR_OF_MEAN|0.024||0.0074|TWO_SIDED|95.0|-0.113|-0.018|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.018|-0.113|0.0074
74017554|NCT00662792|147586918|SUPERIORITY||Differences of adjusted means|0.051|STANDARD_ERROR_OF_MEAN|0.03||0.0898|TWO_SIDED|95.0|-0.008|0.109|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.109|-0.008|0.0898
74017555|NCT00662792|147586918|SUPERIORITY||Difference of adjusted means|0.142|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.083|0.201|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.201|0.083|<.0001
74017556|NCT00662792|147586918|SUPERIORITY||Difference of adjusted means|-0.057|STANDARD_ERROR_OF_MEAN|0.03||0.0601|TWO_SIDED|95.0|-0.116|0.002|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.002|-0.116|0.0601
74017557|NCT00662792|147586919|SUPERIORITY||Difference of adjusted means|-0.028|STANDARD_ERROR_OF_MEAN|0.031||0.3652|TWO_SIDED|95.0|-0.089|0.033|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.033|-0.089|0.3652
74017558|NCT00662792|147586919|SUPERIORITY||Difference of adjusted means|0.042|STANDARD_ERROR_OF_MEAN|0.031||0.1816|TWO_SIDED|95.0|-0.02|0.103|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.103|-0.020|0.1816
74017559|NCT00662792|147586919|SUPERIORITY||Difference of adjusted means|-0.095|STANDARD_ERROR_OF_MEAN|0.031||0.0026|TWO_SIDED|95.0|-0.157|-0.033|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.033|-0.157|0.0026
74046333|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.63||0.668|TWO_SIDED|95.0|-1.5|0.96|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.96|-1.50|0.668
74046334|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.63||0.326|TWO_SIDED|95.0|-0.61|1.85|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.85|-0.61|0.326
74017560|NCT00662792|147586920|SUPERIORITY||Difference of adjusted means|11.8|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|6.9|16.8|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||16.8|6.9|<.0001
74017561|NCT00662792|147586920|SUPERIORITY||Difference of adjusted means|24.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|19.2|29.2|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||29.2|19.2|<.0001
74017562|NCT00662792|147586920|SUPERIORITY||Difference of adjusted means|-3.4|STANDARD_ERROR_OF_MEAN|2.6||0.1804|TWO_SIDED|95.0|-8.5|1.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||1.6|-8.5|0.1804
74017563|NCT00662792|147586921|SUPERIORITY||Difference of adjusted means|8.5|STANDARD_ERROR_OF_MEAN|2.5||0.0008|TWO_SIDED|95.0|3.5|13.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||13.4|3.5|0.0008
74017564|NCT00662792|147586921|SUPERIORITY||Difference of adjusted means|10.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|5.6|15.5|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||15.5|5.6|<.0001
74017565|NCT00662792|147586921|SUPERIORITY||Difference of adjusted means|-12.9|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-17.9|-8.0|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S\_DPI)|||-8.0|-17.9|<.0001
74017566|NCT00662792|147586922|SUPERIORITY||Difference of adjusted means|10.1|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|5.7|14.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||14.6|5.7|<.0001
74017567|NCT00662792|147586922|SUPERIORITY||Difference of adjusted means|17.4|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|12.9|21.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||21.9|12.9|<.0001
74017568|NCT00662792|147586922|SUPERIORITY||Difference of adjusted means|-8.2|STANDARD_ERROR_OF_MEAN|2.3||0.0004|TWO_SIDED|95.0|-12.7|-3.7|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S\_DPI)|||-3.7|-12.7|0.0004
74046335|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.66||0.679|TWO_SIDED|95.0|-1.56|1.01|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.01|-1.56|0.679
74017569|NCT00662792|147586923|SUPERIORITY||Difference of adjusted means|13.1|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|7.2|18.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||18.9|7.2|<.0001
73880611|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0608|TWO_SIDED|95.0|0.95|9.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.77|0.95|0.0608
74017570|NCT00662792|147586923|SUPERIORITY||Difference of adjusted means|23.1|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|17.2|28.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||28.9|17.2|<.0001
74017571|NCT00662792|147586923|SUPERIORITY||Difference in adjusted means|-5.3|STANDARD_ERROR_OF_MEAN|3.0||0.0769|TWO_SIDED|95.0|-11.2|0.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.6|-11.2|0.0769
73880612|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0028|TWO_SIDED|95.0|1.85|19.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||19.34|1.85|0.0028
74096313|NCT03118570|147741809|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.115||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.115
73880613|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|7.84||||0.0005|TWO_SIDED|95.0|2.45|25.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||25.13|2.45|0.0005
74017572|NCT00662792|147586924|SUPERIORITY||Difference of adjusted means|2.8|STANDARD_ERROR_OF_MEAN|3.2||0.3775|TWO_SIDED|95.0|-3.5|9.1|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||9.1|-3.5|0.3775
74017573|NCT00662792|147586924|SUPERIORITY||Difference of adjusted means|7.1|STANDARD_ERROR_OF_MEAN|3.2||0.0285|TWO_SIDED|95.0|0.7|13.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||13.4|0.7|0.0285
74017574|NCT00662792|147586924|SUPERIORITY||Difference of adjusted means|-8.9|STANDARD_ERROR_OF_MEAN|3.2||0.0065|TWO_SIDED|95.0|-15.2|-2.5|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-2.5|-15.2|0.0065
74017575|NCT00662792|147586928|SUPERIORITY||Difference of adjusted means|5.7|STANDARD_ERROR_OF_MEAN|2.4||0.0182|TWO_SIDED|95.0|1.0|10.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Morning PEF||10.4|1.0|0.0182
74017576|NCT00662792|147586928|SUPERIORITY||Difference of adjusted means|6.3|STANDARD_ERROR_OF_MEAN|2.4||0.0091|TWO_SIDED|95.0|1.6|11.1|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Morning PEF||11.1|1.6|0.0091
74017577|NCT00662792|147586928|SUPERIORITY||Difference of adjusted means|-8.0|STANDARD_ERROR_OF_MEAN|2.4||0.001|TWO_SIDED|95.0|-12.8|-3.3|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Morning PEF||-3.3|-12.8|0.0010
74017578|NCT00662792|147586928|SUPERIORITY||Difference of adjusted means|11.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|5.8|16.2|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Evening PEF||16.2|5.8|<.0001
74017579|NCT00662792|147586928|SUPERIORITY||Difference of adjusted means|23.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|18.1|28.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Evening PEF||28.6|18.1|<.0001
74017580|NCT00662792|147586928|SUPERIORITY||Difference of adjusted means|1.5|STANDARD_ERROR_OF_MEAN|2.7||0.5766|TWO_SIDED|95.0|-3.8|6.8|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Evening PEF||6.8|-3.8|0.5766
74017581|NCT00662792|147586929|SUPERIORITY||Difference of adjusted means|0.04|STANDARD_ERROR_OF_MEAN|0.016||0.0137|TWO_SIDED|95.0|0.008|0.071|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Morning FEV1||0.071|0.008|0.0137
74017582|NCT00662792|147586929|SUPERIORITY||Difference of adjusted means|0.027|STANDARD_ERROR_OF_MEAN|0.016||0.0981|TWO_SIDED|95.0|-0.005|0.059|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Morning FEV1||0.059|-0.005|0.0981
74017583|NCT00662792|147586929|SUPERIORITY||Difference of adjusted means|-0.022|STANDARD_ERROR_OF_MEAN|0.016||0.1827|TWO_SIDED|95.0|-0.054|0.01|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Morning FEV1||0.010|-0.054|0.1827
73880614|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8393|TWO_SIDED|95.0|0.3|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.39|0.30|0.8393
74017584|NCT00662792|147586929|SUPERIORITY||Difference of adjusted means|0.057|STANDARD_ERROR_OF_MEAN|0.018||0.0014|TWO_SIDED|95.0|0.022|0.092|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Evening FEV1||0.092|0.022|0.0014
74017585|NCT00662792|147586929|SUPERIORITY||Difference of adjusted means|0.105|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.07|0.14|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Evening FEV1||0.140|0.070|<.0001
74017586|NCT00662792|147586929|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.018||0.2584|TWO_SIDED|95.0|-0.015|0.056|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Evening FEV1||0.056|-0.015|0.2584
74017587|NCT00662792|147586930|SUPERIORITY||Difference of adjusted means|-0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0027|TWO_SIDED|95.0|-0.11|-0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Daytime||-0.02|-0.11|0.0027
74017588|NCT00662792|147586930|SUPERIORITY||Difference of adjusted means|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.4587|TWO_SIDED|95.0|-0.06|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Daytime||0.03|-0.06|0.4587
74017589|NCT00662792|147586930|SUPERIORITY||Difference of adjusted means|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1535|TWO_SIDED|95.0|-0.01|0.08|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Daytime||0.08|-0.01|0.1535
74096314|NCT03118570|147741809|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.356||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.356
74096315|NCT03118570|147741809|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.205||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.205
74017590|NCT00662792|147586930|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.02||0.0002|TWO_SIDED|95.0|-0.14|-0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Night-time||-0.05|-0.14|0.0002
74017591|NCT00662792|147586930|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0006|TWO_SIDED|95.0|-0.14|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Night-time||-0.04|-0.14|0.0006
74017592|NCT00662792|147586930|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.5784|TWO_SIDED|95.0|-0.06|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Night-time||0.04|-0.06|0.5784
74017593|NCT00662792|147586930|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.02||0.0003|TWO_SIDED|95.0|-0.14|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|24 hours||-0.04|-0.14|0.0003
74017594|NCT00662792|147586930|SUPERIORITY||Difference of adjusted means|-0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0042|TWO_SIDED|95.0|-0.12|-0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|24 hours||-0.02|-0.12|0.0042
74017595|NCT00662792|147586930|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.9978|TWO_SIDED|95.0|-0.05|0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|24 hours||0.05|-0.05|0.9978
74017596|NCT00662792|147586931|SUPERIORITY||Difference of adjusted means|-0.33|STANDARD_ERROR_OF_MEAN|0.11||0.0029|TWO_SIDED|95.0|-0.55|-0.11|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Daytime||-0.11|-0.55|0.0029
74046336|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|1.86|STANDARD_ERROR_OF_MEAN|0.66||0.005|TWO_SIDED|95.0|0.57|3.14|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.14|0.57|0.005
74017597|NCT00662792|147586931|SUPERIORITY||Difference of adjusted means|-0.36|STANDARD_ERROR_OF_MEAN|0.11||0.0012|TWO_SIDED|95.0|-0.58|-0.14|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Daytime||-0.14|-0.58|0.0012
74046337|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.72||0.399|TWO_SIDED|95.0|-0.8|2.01|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.01|-0.80|0.399
74046338|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|2.52|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|1.12|3.92|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.92|1.12|<0.001
74046339|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.668|TWO_SIDED|95.0|-1.08|1.68|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.68|-1.08|0.668
74046340|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|1.76|STANDARD_ERROR_OF_MEAN|0.7||0.012|TWO_SIDED|95.0|0.39|3.13|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.13|0.39|0.012
74096316|NCT03118570|147741809|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.078||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.078
74096317|NCT03118570|147741810|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.037
74017598|NCT00662792|147586931|SUPERIORITY||Difference of adjusted means|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0829|TWO_SIDED|95.0|-0.02|0.25|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Daytime||0.25|-0.02|0.0829
74017599|NCT00662792|147586931|SUPERIORITY||Difference of adjusted means|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0115|TWO_SIDED|95.0|-0.3|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Night-time||-0.04|-0.30|0.0115
74046341|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.75||0.109|TWO_SIDED|95.0|-0.27|2.67|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.67|-0.27|0.109
74096318|NCT03118570|147741810|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.342||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.342
74096319|NCT03118570|147741810|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.515||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.515
74096320|NCT03118570|147741810|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.786||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.786
74096321|NCT03118570|147741810|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.212||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.212
74096322|NCT03118570|147741810|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.655||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.655
74096323|NCT03970837|147741813|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.87|3.53|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.53|1.87|<0.0001
74096324|NCT03970837|147741813|SUPERIORITY||Odds Ratio (OR)|2.55|||<|0.0001|TWO_SIDED|95.0|1.85|3.5|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.50|1.85|<0.0001
74096325|NCT03970837|147741813|SUPERIORITY||Odds Ratio (OR)|5.38|||<|0.0001|TWO_SIDED|95.0|3.66|7.9|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 05mg dose of Tofacitinib and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 05mg dose of Tofacitinib differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||7.90|3.66|<0.0001
74096326|NCT03970837|147741813|SUPERIORITY||Odds Ratio (OR)|0.48|||<|0.0001|TWO_SIDED|95.0|0.34|0.66|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90 mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.66|0.34|<0.0001
74096327|NCT03970837|147741813|SUPERIORITY||Odds Ratio (OR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.34|0.66|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.66|0.34|<0.0001
74096328|NCT03970837|147741817|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 95% Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Difference in Percentage|-14.7|||||TWO_SIDED|95.0|-21.3|-8.1|||Regression, Logistic|Difference in proportion and 95% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-8.1|-21.3|
74096329|NCT03970837|147741817|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 95% Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Difference in Percentage|-17.2|||||TWO_SIDED|95.0|-23.9|-10.6|||Regression, Logistic|Difference in proportion and 95% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-10.6|-23.9|
74096330|NCT01997229|147742026|SUPERIORITY||Mean Difference (Net)|-11.7||||0.0698|TWO_SIDED|95.0|-24.33|0.96|||ANCOVA|||||0.96|-24.33|0.0698
74096331|NCT04682730|147742060|SUPERIORITY||Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.13||0.18|TWO_SIDED|95.0|0.58|1.11|||Mixed Models Analysis|||||1.11|0.58|0.18
74096332|NCT04682730|147742062|OTHER|single intervention group across 16 clinics|mean total program costs in 2021 dollars|7845.0|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|6378.0|9312.0|||||An opportunity cost approach was used. Costs estimated: Develop workbook- guideline, EHR data analyses, survey, evidence review- \& print; facilitator training/delivery/program tailoring; staff time; implemented strategies; dental sealant placements.|Mean Total Program costs per clinic for the KPNW Dental system.||9312|6378|
74096333|NCT04682730|147742066|OTHER|single intervention group across 16 clinics|mean total costs/per clinic per sealant|1321.0|STANDARD_DEVIATION|1245.0|||TWO_SIDED|95.0|845.0|3208.0|||||Total cost per sealant calculated as quotient of total intervention costs ($125,521) \& total sealants placed (95), is = to mean cost/sealant across each clinic ($7845/5.938).|Mean Total Program costs per sealant per clinic for the KPNW Dental system.||3208|845|
74096334|NCT04682730|147742068|OTHER|descriptive analysis|percentage|100.0|||||TWO_SIDED||||||||||89/89 treatment plans completed by the end of the period.|||
74096335|NCT05091307|147742135|NON_INFERIORITY|The criterion for non-inferiority (NI) was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.28|||||TWO_SIDED|95.0|1.09|1.53|||ANOVA|||A/Victoria (H1N1): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.53|1.09|
74096336|NCT05091307|147742135|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.23|||||TWO_SIDED|95.0|1.05|1.45|||ANOVA|||A/Cambodia (H3N2): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.45|1.05|
74017600|NCT00662792|147586931|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.1772|TWO_SIDED|95.0|-0.22|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Night-time||0.04|-0.22|0.1772
74017601|NCT00662792|147586931|SUPERIORITY||Difference of adjusted means|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.6895|TWO_SIDED|95.0|-0.18|0.27|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Night-time||0.27|-0.18|0.6895
74017602|NCT00662792|147586931|SUPERIORITY||Difference of adjusted means|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0013|TWO_SIDED|95.0|-0.84|-0.21|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Over 24 hours||-0.21|-0.84|0.0013
74017603|NCT00662792|147586931|SUPERIORITY||Difference of adjusted means|-0.47|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.78|-0.15|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Over 24 hours||-0.15|-0.78|0.0040
74017604|NCT00662792|147586931|SUPERIORITY||Difference of adjusted means|0.16|STANDARD_ERROR_OF_MEAN|0.16||0.3287|TWO_SIDED|95.0|-0.16|0.48|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Over 24 hours||0.48|-0.16|0.3287
74046342|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|1.03|STANDARD_ERROR_OF_MEAN|0.74||0.163|TWO_SIDED|95.0|-0.42|2.48|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.48|-0.42|0.163
74046343|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.73||0.424|TWO_SIDED|95.0|-2.02|0.85|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.85|-2.02|0.424
74046344|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.72||0.635|TWO_SIDED|95.0|-1.07|1.76|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.76|-1.07|0.635
74096337|NCT05091307|147742135|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.84|1.19|||ANOVA|||B/Victoria (B/Victoria): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.19|0.84|
74017605|NCT00662792|147586932|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9956|TWO_SIDED|95.0|-0.03|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.03|-0.03|0.9956
74017606|NCT00662792|147586932|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.71|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.02|-0.03|0.7100
74017607|NCT00662792|147586932|SUPERIORITY||Difference of adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3659|TWO_SIDED|95.0|-0.02|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.04|-0.02|0.3659
74017608|NCT00662792|147586933|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.4416|TWO_SIDED|95.0|-0.04|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.02|-0.04|0.4416
74017609|NCT00662792|147586933|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.7058|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.02|-0.03|0.7058
74017610|NCT00662792|147586933|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.1494|TWO_SIDED|95.0|-0.01|0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.05|-0.01|0.1494
74017611|NCT00662792|147586934|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.998|TWO_SIDED|95.0|-0.06|0.06|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.06|-0.06|0.9980
74017612|NCT00662792|147586934|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4618|TWO_SIDED|95.0|-0.04|0.08|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.08|-0.04|0.4618
74017613|NCT00662792|147586934|SUPERIORITY||Difference of adjusted means|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0418|TWO_SIDED|95.0|0.0|0.12|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.12|0.00|0.0418
74017614|NCT00662792|147586935|SUPERIORITY||Difference of adjusted means|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4206|TWO_SIDED|95.0|-0.08|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.03|-0.08|0.4206
74017615|NCT00662792|147586935|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.8723|TWO_SIDED|95.0|-0.05|0.06|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.06|-0.05|0.8723
74017616|NCT00662792|147586935|SUPERIORITY||Difference of adjusted means|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1005|TWO_SIDED|95.0|-0.01|0.11|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.11|-0.01|0.1005
74017617|NCT03021642|147586956|SUPERIORITY_OR_OTHER_LEGACY||Geometric Least square (LS) mean ratio|98.68|||||TWO_SIDED|90.0|93.67|103.96||||||||103.96|93.67|
74017618|NCT03021642|147586957|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|95.71|||||TWO_SIDED|90.0|88.43|103.59||||||||103.59|88.43|
74017619|NCT03021642|147586958|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|96.88|||||TWO_SIDED|90.0|90.8|103.36||||||||103.36|90.8|
74017620|NCT03021642|147586959|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|0.0||||0.8981|TWO_SIDED|90.0|-1.0|1.025|||Wilcoxon signed-rank test|||||1.025|-1.000|0.8981
74017621|NCT00756938|147586973|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.22||||0.753|TWO_SIDED|95.0|-6.45|8.9|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage||||8.90|-6.45|0.753
74017622|NCT00756938|147586974|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.81||||0.643|TWO_SIDED|95.0|-5.9|9.51|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage||||9.51|-5.90|0.643
74017623|NCT00441545|147586977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113||95.0|||||ANCOVA|||||||0.1130
74017624|NCT00441545|147586978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0249||95.0|||||ANCOVA|||||||0.0249
74017625|NCT02347176|147586981|SUPERIORITY||Adjusted Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|1.968||0.143|TWO_SIDED|95.0|-6.78|0.99|||Mixed Model Repeated Measures Analysis|||||0.99|-6.78|0.143
74017626|NCT02347176|147586981|SUPERIORITY||Adjusted Mean Difference|-4.36|STANDARD_ERROR_OF_MEAN|1.951||0.027|TWO_SIDED|95.0|-8.22|-0.51|||Mixed Model Repeated Measures Analysis|||||-0.51|-8.22|0.027
74017627|NCT02347176|147586981|SUPERIORITY||Adjusted Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.932||0.011|TWO_SIDED|95.0|-8.76|-1.13|||Mixed Model Repeated Measures Analysis|||||-1.13|-8.76|0.011
74017628|NCT02347176|147586982|SUPERIORITY||Odds Ratio (OR)|0.98||||0.974|TWO_SIDED|95.0|0.29|3.32|||Regression, Logistic|||||3.32|0.29|0.974
74017629|NCT02347176|147586982|SUPERIORITY||Odds Ratio (OR)|1.85||||0.281|TWO_SIDED|95.0|0.61|5.65|||Regression, Logistic|||||5.65|0.61|0.281
74017630|NCT02347176|147586982|SUPERIORITY||Odds Ratio (OR)|2.83||||0.061|TWO_SIDED|95.0|0.95|8.37|||Regression, Logistic|||||8.37|0.95|0.061
74017631|NCT02474082|147586991|SUPERIORITY||Odds Ratio (OR)|16.61|||<|0.0001|TWO_SIDED|95.0|7.79|35.4|||Regression, Logistic|||||35.40|7.79|<.0001
74017632|NCT03403205|147587012|OTHER||LS Mean Difference|1.64|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|1.14|2.13||Test was performed at a significance level of 0.05.|ANCOVA|||Analysis was performed using ANCOVA model, which included treatment, cohort, and baseline value. Missing imputation was performed: 1) for intermediate missing, interpolation was used to fill out missing values. 2) For participants who die, baseline dNCC was carried forward from discontinuation to week 48. 3) For others, multiple imputation was used to impute missing dNCC assuming data were missing not at random.||2.13|1.14|< 0.0001
74017633|NCT03403205|147587012|OTHER||LS Mean Difference|3.79|STANDARD_ERROR_OF_MEAN|0.584|<|0.0001|TWO_SIDED|95.0|2.65|4.94||Test was performed at a significance level of 0.05.|ANCOVA|||Analysis was performed using ANCOVA model, which included treatment, cohort, and baseline value. Missing imputation was performed: 1) for intermediate missing, interpolation was used to fill out missing values. 2) For participants who die, baseline dNCC was carried forward from discontinuation to week 48. 3) For others, multiple imputation was used to impute missing dNCC assuming data were missing not at random.||4.94|2.65|< 0.0001
74017634|NCT01834729|147587024|SUPERIORITY|||||||0.78|||||||Least squares means|||||||0.78
74017635|NCT01834729|147587025|SUPERIORITY|||||||0.57|||||||Least squares means|||||||0.57
74017636|NCT00288080|147587029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0398|||||||Log Rank|||The study was designed to detect an improvement in the 4-year overall survival rate from 86% (AS+RT) to 93% (AS+RT+CT). Assuming an exponential survival distribution for each arm, then an absolute improvement of 7% in the 4-year overall survival rate translates to a 51% relative reduction (hazard ratio 0.49) in the yearly death rate. Under a 1-sided significance level of 0.05 and 90% power, at least 78 deaths and 486 cases were required to perform the primary endpoint analysis.||||0.0398
74017637|NCT00288080|147587030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||Log Rank|||Biochemical control rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-sided log-rank test with a significance level of 0.05.||||0.22
74017638|NCT00288080|147587032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Log Rank|||Distant failure rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-side log-rank test at the 0.05 significance level.||||0.21
74017639|NCT00288080|147587033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0484|||||||Log Rank|||Disease-free survival rates were compared by a two-sided log-rank test at a significance level of 0.05.||||0.0484
74017640|NCT02340663|147587050|OTHER|||||||0.23|||||||t-test, 2 sided|||||||0.23
74017641|NCT02340663|147587051|OTHER|||||||0.045|||||||ANOVA|||||||0.045
74017642|NCT02340663|147587052|OTHER|||||||0.665|||||||t-test, 2 sided|||||||0.665
74017643|NCT02340663|147587053|OTHER|||||||0.249|||||||Wilcoxon (Mann-Whitney)|||||||0.249
74017644|NCT02340663|147587054|OTHER|||||||0.626|||||||Wilcoxon (Mann-Whitney)|||||||0.626
74017645|NCT02340663|147587055|OTHER|||||||0.695|||||||t-test, 2 sided|||||||0.695
74017646|NCT02340663|147587056|OTHER|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||||||0.255
74017647|NCT02340663|147587057|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||.049
74017648|NCT02340663|147587060|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.750
74017649|NCT02340663|147587061|OTHER||||||<|0.01||||||The P-value given is the computed value|Mixed Models Analysis|||||||<0.01
74017650|NCT02340663|147587062|OTHER|||||||0.544|||||||Wilcoxon (Mann-Whitney)|||||||0.544
74017651|NCT02340663|147587063|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.220
74017652|NCT02340663|147587064|OTHER|||||||0.081|||||||Wilcoxon (Mann-Whitney)|||||||0.081
74017653|NCT02340663|147587065|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
74017654|NCT02340663|147587066|OTHER|||||||0.731|||||||Wilcoxon (Mann-Whitney)|||||||0.731
74017655|NCT02340663|147587067|OTHER|||||||0.238|||||||Wilcoxon (Mann-Whitney)|||||||0.238
74017656|NCT02340663|147587068|OTHER|||||||0.952||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA|||||||0.952
74017657|NCT02340663|147587069|OTHER|||||||0.53||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA|||||||0.53
74017658|NCT02340663|147587070|OTHER|||||||0.292||||||"The P-value refers to the difference in group means, see Group Means row in the table."|Mixed Models Analysis|||||||0.292
74017659|NCT02340663|147587071|OTHER|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.||||0.289
74017660|NCT02340663|147587072|OTHER|||||||0.287||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.287
74017661|NCT02340663|147587073|OTHER|||||||0.505||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.505
74017662|NCT02340663|147587074|OTHER|||||||0.643||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.643
74017663|NCT02340663|147587075|OTHER|||||||0.923||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.923
74017664|NCT02979431|147587076|SUPERIORITY||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||<0.001
74017665|NCT02979431|147587076|SUPERIORITY||||||=|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||=0.001
74017666|NCT02979431|147587076|SUPERIORITY||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||<0.001
74017667|NCT02979431|147587077|SUPERIORITY||Mean Difference (Net)|-0.6452|STANDARD_ERROR_OF_MEAN|0.5843|=|0.271|TWO_SIDED||||||Mixed Models Analysis|||A comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to + including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used.The model was fitted using an unstructured variance-covariance matrix.||||=0.271
74046345|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.75||0.855|TWO_SIDED|95.0|-1.34|1.61|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-1.34|0.855
74046346|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|1.84|STANDARD_ERROR_OF_MEAN|0.74||0.013|TWO_SIDED|95.0|0.38|3.3|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.30|0.38|0.013
74096338|NCT05091307|147742135|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.88|1.21|||ANOVA|||B/Phuket (B/Yamagata): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.21|0.88|
74096339|NCT05091307|147742136|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.26|||ANOVA|||Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.26|0.97|
74046347|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.81||0.292|TWO_SIDED|95.0|-2.44|0.73|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.73|-2.44|0.292
74046348|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.8||0.897|TWO_SIDED|95.0|-1.47|1.68|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.68|-1.47|0.897
74046349|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.84||0.39|TWO_SIDED|95.0|-2.36|0.92|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.92|-2.36|0.390
74096340|NCT03611543|147742154|SUPERIORITY||||||<|0.0001||||||Information related to the INVESTIGATIONAL group.|Wilcoxon Rank-Sum test|||||||<0.0001
74096341|NCT02081209|147742159|OTHER||sucess percentage|82.4|||||TWO_SIDED|95.0|76.4|87.3||||||||87.3|76.4|
74096342|NCT02081209|147742159|OTHER||sucess percentage|77.4|||||TWO_SIDED|95.0|68.1|85.1||||||||85.1|68.1|
74017668|NCT02979431|147587077|SUPERIORITY||Difference in LS means|-0.4904|STANDARD_ERROR_OF_MEAN|0.5862|=|0.404|TWO_SIDED||||||Mixed Models Analysis|||||||=0.404
74017669|NCT02979431|147587077|SUPERIORITY||Difference in LS means|-0.2156|STANDARD_ERROR_OF_MEAN|0.5842|=|0.713|TWO_SIDED||||||Mixed Models Analysis|||||||=0.713
74017670|NCT01331304|147587093|SUPERIORITY_OR_OTHER|||||||0.59||||||Because this study has co-primary outcomes (CGI-EI and NCAs), the analyses of the treatment effect in the two primary hypotheses each involved a two-tailed alpha-level of 0.025.|Mixed Models Analysis|||For the first co-primary aim, mixed-effects linear regression analyses compared the two intervention groups on the repeated assessments of the CGI-EI over 6 months.||||0.59
74017671|NCT01331304|147587094|SUPERIORITY_OR_OTHER|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||For the second co-primary, patient monthly rates of NCAs (determined by dividing total number of NCAs during follow-up by the length of follow-up - to account for attrition and resulting differential exposure time) for treatment groups were compared using a Wilcoxon rank-sum test.||||0.118
74017672|NCT01331304|147587095|SUPERIORITY|||||||0.11||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated collection of measures relevant to calculation of the Framingham Risk Score over 6 months||||0.11
74017673|NCT01331304|147587096|SUPERIORITY|||||||0.7||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated assessment of the LIFE-RIFT over 6 months||||0.70
74017674|NCT02004873|147587099|SUPERIORITY_OR_OTHER||Kaplan-Meier survival probability (%)|96.0|||<|0.0001|TWO_SIDED|98.66|93.3|97.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|z-test, 1-sided||"The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.~The coverage level for the confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis."|"Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%.~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%."||97.6|93.3|<0.0001
74017675|NCT02004873|147587100|SUPERIORITY_OR_OTHER||Percentage of subjects (%)|98.3|||<|0.0001|TWO_SIDED|98.66|95.4|99.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is greater than 80%."||99.6|95.4|<0.0001
74046350|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.83||0.659|TWO_SIDED|95.0|-1.26|1.99|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.99|-1.26|0.659
74046351|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.8||0.847|TWO_SIDED|95.0|-1.73|1.42|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.42|-1.73|0.847
74017676|NCT02004873|147587101|SUPERIORITY_OR_OTHER||Percentage of subjects (%)|99.6|||<|0.0001|TWO_SIDED|98.66|97.5|100.0||Holm adjustment for multiple comparisons for secondary objectives was used. The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is less than or equal to 85%.~Alternative hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is greater than 85%."||100.0|97.5|<0.0001
74096343|NCT02081209|147742159|OTHER||sucess percentage|79.2|||||TWO_SIDED|95.0|65.0|89.5||||||||89.5|65.0|
74096344|NCT02081209|147742159|OTHER||sucess percentage|94.0|||||TWO_SIDED|95.0|84.6|98.8||||||||98.8|84.6|
74096345|NCT02081209|147742160|OTHER||Mean Difference (Net)|2.3|STANDARD_DEVIATION|1.9|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73880615|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|4.01||||0.0215|TWO_SIDED|95.0|1.23|13.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.10|1.23|0.0215
74096346|NCT02081209|147742160|OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|0.5|2.1||||||||2.1|0.5|
74096347|NCT02081209|147742160|OTHER||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|2.0|4.1||||||||4.1|2.0|
74096348|NCT02081209|147742161|OTHER||||||||||||||||||Data from the 16-week follow-up questionnaire were tabulated for all subjects with completed questionnaires.. All confidence intervals were calculated at 95%. Alpha was calculated to be 0.05, critical probability (p\*) was calculated to be 0.975. Assuming normal distribution of survey recipients, a standard deviation of 1.96 is used to calculate the standard margin of error.|||
74096349|NCT05205772|147742162|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
74096350|NCT05205772|147742162|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
74096351|NCT05205772|147742162|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
74096352|NCT05205772|147742162|SUPERIORITY|||||||0.98|||||||ANOVA|||||||0.98
74096353|NCT05205772|147742162|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
74096354|NCT05205772|147742162|SUPERIORITY|||||||0.63|||||||ANOVA|||||||0.63
73888073|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.6||||0.647|TWO_SIDED|95.0|-71.9|44.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||44.8|-71.9|0.6470
74096355|NCT05205772|147742163|OTHER|||||||0.38||||||Adjusted for age.|Regression, Linear|||||||0.38
74017677|NCT02004873|147587102|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin is 0.35. The Micra sensor indicated rate is considered proportional to the workload if the 90% CI for the Kay-Wilkoff slope parameter falls into \[0.65, 1.35\].|Slope|0.864|||<|0.001|TWO_SIDED|90.0|0.768|0.961||Holm adjustment for multiple comparisons for secondary objectives was used. Two One-sided Test (TOST) procedure was used at the 0.05 significance level.|t-test, 1 sided|Two One-sided Test (TOST)|A random effect linear regression model was used to assess if the Micra sensor-indicated rate was proportional to the workload using the Kay-Wilkoff model. The Kay-Wilkoff slope parameter was estimated along with its 90% CI.|Null hypothesis: Kay-Wilkoff slope parameter is \< 0.65 or \> 1.35 Alternative hypothesis: Kay-Wilkoff slope parameter is between 0.65 and 1.35||0.961|0.768|<0.001
74017678|NCT01060059|147587164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.831|TWO_SIDED|95.0|0.62|1.46|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline Gender (Male vs. Female), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.46|0.62|0.831
74017679|NCT01060059|147587164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.554|TWO_SIDED|95.0|0.74|1.76||Baseline Medical conditions (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.||1.76|0.74|0.554
74017680|NCT01060059|147587164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.714|TWO_SIDED|95.0|0.43|3.42||Baseline gastrointestinal symptoms (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.||3.42|0.43|0.714
74017681|NCT01060059|147587165|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||<|0.001|TWO_SIDED|95.0|0.6|0.78|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline HbA1c was 1% more, was it associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.78|0.60|<0.001
74017682|NCT01060059|147587166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.055|TWO_SIDED|95.0|0.96|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if longer duration of diabetes was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|0.96|0.055
74017683|NCT01060059|147587167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|||<|0.001|TWO_SIDED|95.0|0.95|0.99|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if older age (1 year older), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.99|0.95|<0.001
74017684|NCT01060059|147587168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||<|0.001|TWO_SIDED|95.0|1.15|1.23|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher BMI (1 kg/m\^2 higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.23|1.15|<0.001
74096356|NCT05205772|147742164|OTHER|||||||0.67||||||Adjusted for age.|Regression, Linear|||||||0.67
74096357|NCT05205772|147742165|OTHER|||||||0.156|||||||Regression, Linear|||||||0.156
74096358|NCT06378749|147742170|OTHER|||||||0.029|||||||t-test, 2 sided|||||||.029
74096359|NCT06378749|147742171|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74096360|NCT06378749|147742172|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74096361|NCT06378749|147742173|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74096362|NCT06378749|147742174|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74096363|NCT05538065|147742195|SUPERIORITY||Risk Ratio (RR)|1.4||||0.002|TWO_SIDED|95.0|1.1|1.78||Adjusted for multiple comparisons|Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and binary errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||1.78|1.10|0.002
74096364|NCT05538065|147742195|SUPERIORITY||Risk Ratio (RR)|1.26||||0.039|TWO_SIDED|95.0|1.01|1.57||Adjusted for multiple comparisons|Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and binary errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||1.57|1.01|0.039
74096365|NCT05538065|147742196|SUPERIORITY||Mean Difference (Final Values)|29.0||||0.386|TWO_SIDED|95.0|-36.6|94.6||Adjusted for multiple testing|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||94.6|-36.6|0.386
73880616|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|4.42||||0.0112|TWO_SIDED|95.0|1.4|13.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.94|1.40|0.0112
74017685|NCT01060059|147587169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.026|TWO_SIDED|95.0|1.0|1.05|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if greater height (1 cm higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.05|1.00|0.026
74096366|NCT05538065|147742196|SUPERIORITY||Mean Difference (Final Values)|38.1||||272|TWO_SIDED|95.0|-29.9|106.1||Adjusted for multiple comparisons|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||106.1|-29.9|272
74096367|NCT05538065|147742197|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.657|TWO_SIDED|95.0|-74.5|47.0||Adjusted for multiple testing|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||47.0|-74.5|0.657
74096368|NCT05538065|147742197|SUPERIORITY||Mean Difference (Final Values)|15.1||||0.696|TWO_SIDED|95.0|-60.7|91.0|||Regression, Linear|Adjusted for multiple testing||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||91.0|-60.7|0.696
74096369|NCT03589768|147742201|OTHER|N/A, Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-11.9|10.3|||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|||10.3|-11.9|
74096370|NCT03589768|147742202|SUPERIORITY||Risk Difference (RD)|4.62||||0.559|TWO_SIDED|95.0|-6.25|15.5|||Fisher Exact||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|||15.5|-6.25|0.559
74096371|NCT03589768|147742203|OTHER|Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-9.3|9.8|||||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|9.8|-9.3|
74017686|NCT01060059|147587170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.007|TWO_SIDED|95.0|0.18|0.77|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline creatinine (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.77|0.18|0.007
74017687|NCT01060059|147587170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.094|TWO_SIDED|95.0|0.97|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting HDL cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|0.97|0.094
74017688|NCT01060059|147587170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.259|TWO_SIDED|95.0|1.0|1.01|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting total cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.01|1.00|0.259
74017689|NCT01060059|147587170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.123|TWO_SIDED|95.0|1.0|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting triglycerides (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|1.00|0.123
74017690|NCT01128829|147587171|SUPERIORITY_OR_OTHER|||||||0.025|||||||t-test, 2 sided|||Each subject served as their own control. We compared insulin concentrations when subjects consumed sucralose before a glucose load (experimental condition) with those on the day consumed water before a glucose load (control condition).||||0.025
74017691|NCT00848354|147587173|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel chi-square test, stratified by country, was used to calculate p-value. Assuming ACR50 response at Week 24 to be 23% in the DMARD combination therapy group and 37% in the etanercept + methotrexate group, a study enrolling 276 participants assigned to etanercept + methotrexate and 138 participants assigned to DMARD combination therapy has 80% power to reject the null hypothesis of no difference in response rates testing at the type I error = 0.05 level.||||<0.0001
74096372|NCT03589768|147742204|SUPERIORITY||Risk Difference (RD)|6.06||||0.29|TWO_SIDED|95.0|-3.82|15.9|||Fisher Exact||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|15.9|-3.82|0.290
74046352|NCT00565812|147644919|SUPERIORITY_OR_OTHER||LS mean difference|0.77|STANDARD_ERROR_OF_MEAN|0.8||0.333|TWO_SIDED|95.0|-0.79|2.34|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.34|-0.79|0.333
74046353|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.42||0.238|TWO_SIDED|95.0|-1.31|0.32|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.32|-1.31|0.238
74096373|NCT03589768|147742206|OTHER|Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|1.5|||||TWO_SIDED|95.0|-6.4|7.3|||||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|7.3|-6.4|
74096374|NCT03589768|147742207|SUPERIORITY||Ratio|7.0|||<|0.0001|TWO_SIDED|95.0|4.6|10.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth day timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|10.7|4.6|<0.0001
74096375|NCT03589768|147742207|SUPERIORITY||Ratio|4.8|||<|0.0001|TWO_SIDED|95.0|3.2|7.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for Prior to receipt of first dose of DTwP (approximately 6 weeks of age) timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|7.3|3.2|<0.0001
74096376|NCT03589768|147742207|SUPERIORITY||Ratio|2.9|||<|0.0001|TWO_SIDED|95.0|1.8|4.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for One month after receipt of first dose of DTwP (approximately 10 weeks of age) timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|4.8|1.8|<0.0001
74096377|NCT03589768|147742207|SUPERIORITY||Ratio|0.3||||0.0068|TWO_SIDED|95.0|0.1|0.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for One month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.7|0.1|0.0068
74096378|NCT03589768|147742207|SUPERIORITY||Ratio|0.3||||0.0003|TWO_SIDED|95.0|0.1|0.5|||t-test, 2 sided|Test compares differences in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.5|0.1|0.0003
74017692|NCT00848354|147587174|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||Analysis of covariance (ANCOVA) model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||<0.0001
74017693|NCT00848354|147587175|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for vitality domain at Week 24.||||0.0003
74017694|NCT00848354|147587175|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for mental component at Week 24.||||0.0002
74017695|NCT00848354|147587175|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for physical component at Week 24.||||<0.0001
74017696|NCT00848354|147587176|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model on ranks of change in mTSS with treatment group and center main effects and the Baseline rank as covariate was used to calculate p-value.||||0.0270
74096379|NCT03589768|147742208|SUPERIORITY||Ratio|0.9||||0.7102|TWO_SIDED|95.0|0.7|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.7|0.7102
74096380|NCT03589768|147742208|SUPERIORITY||Ratio|8.7|||<|0.0001|TWO_SIDED|95.0|6.2|12.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|12.0|6.2|<0.0001
74017697|NCT00848354|147587177|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
74017698|NCT00848354|147587180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.39|||<|0.0001|TWO_SIDED|95.0|2.25|18.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||18.2|2.25|<0.0001
74017699|NCT00848354|147587180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.62|9.49||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||9.49|2.62|<0.0001
74017700|NCT00848354|147587180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.6|||<|0.0001|TWO_SIDED|95.0|2.19|5.94||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.94|2.19|<0.0001
74017701|NCT00848354|147587180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.57|6.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.53|2.57|<0.0001
74017702|NCT00848354|147587180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED|95.0|2.51|6.16||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.16|2.51|<0.0001
74017703|NCT00848354|147587180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.46|5.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||5.93|2.46|<0.0001
74017704|NCT00848354|147587180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.39|||<|0.0001|TWO_SIDED|95.0|3.41|8.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||8.53|3.41|<0.0001
74017705|NCT00848354|147587182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84|||<|0.0001|TWO_SIDED|95.0|2.37|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||6.21|2.37|<0.0001
74017706|NCT00848354|147587182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.0001|TWO_SIDED|95.0|2.19|5.11||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.11|2.19|<0.0001
74017707|NCT00848354|147587182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9|||<|0.0001|TWO_SIDED|95.0|1.9|4.43||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||4.43|1.90|<0.0001
74046354|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.41||0.815|TWO_SIDED|95.0|-0.72|0.91|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.91|-0.72|0.815
74096381|NCT03589768|147742208|SUPERIORITY||Ratio|4.7|||<|0.0001|TWO_SIDED|95.0|3.3|6.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|6.6|3.3|<0.0001
74096382|NCT03589768|147742208|SUPERIORITY||Ratio|3.3|||<|0.0001|TWO_SIDED|95.0|2.1|5.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|5.2|2.1|<0.0001
74017708|NCT00848354|147587182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.0001|TWO_SIDED|95.0|2.06|4.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||4.96|2.06|<0.0001
74017709|NCT00848354|147587182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.91|||<|0.0001|TWO_SIDED|95.0|2.46|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.21|2.46|<0.0001
74017710|NCT00848354|147587182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.45|6.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.22|2.45|<0.0001
74017711|NCT00848354|147587182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.94|||<|0.0001|TWO_SIDED|95.0|3.13|7.78||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||7.78|3.13|<0.0001
74017712|NCT00848354|147587184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.19||||0.1086|TWO_SIDED|95.0|0.66|40.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||40.9|0.66|0.1086
74017713|NCT00848354|147587184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.58||||0.0392|TWO_SIDED|95.0|1.04|12.3||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||12.3|1.04|0.0392
74017714|NCT00848354|147587184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.27|||<|0.0001|TWO_SIDED|95.0|2.04|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||13.6|2.04|<0.0001
74017715|NCT00848354|147587184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.69|||<|0.0001|TWO_SIDED|95.0|2.39|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||13.6|2.39|<0.0001
73880617|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3498|TWO_SIDED|95.0|0.55|5.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.29|0.55|0.3498
74017716|NCT00848354|147587184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.02|7.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||7.09|2.02|<0.0001
74017717|NCT00848354|147587184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.02|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.60|2.02|<0.0001
74017718|NCT00848354|147587184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2|||<|0.0001|TWO_SIDED|95.0|2.36|7.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||7.46|2.36|<0.0001
74017719|NCT00848354|147587186|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
74017720|NCT00848354|147587188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.23|||<|0.0001|TWO_SIDED|95.0|3.88|10.0||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value.||10.00|3.88|<0.0001
74046355|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.42||0.508|TWO_SIDED|95.0|-0.54|1.1|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.10|-0.54|0.508
74046356|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.42||0.004|TWO_SIDED|95.0|0.38|2.02|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.02|0.38|0.004
74046357|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.45||0.683|TWO_SIDED|95.0|-1.07|0.7|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.70|-1.07|0.683
73880618|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1981|TWO_SIDED|95.0|0.69|6.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.08|0.69|0.1981
74017721|NCT00848354|147587189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.79|||<|0.0001|TWO_SIDED|95.0|3.49|17.39||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value.||17.39|3.49|<0.0001
74017722|NCT00848354|147587190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.24|5.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.46|2.24|<0.0001
74017723|NCT00848354|147587190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.91|8.55||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||8.55|2.91|<0.0001
74017724|NCT00848354|147587190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|2.93|12.02||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||12.02|2.93|<0.0001
74017725|NCT00848354|147587190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57|||<|0.0001|TWO_SIDED|95.0|2.27|9.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||9.21|2.27|<0.0001
74017726|NCT00848354|147587190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.08|||<|0.0001|TWO_SIDED|95.0|2.74|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.48|2.74|<0.0001
74017727|NCT00848354|147587190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.86|||<|0.0001|TWO_SIDED|95.0|3.0|15.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||15.72|3.00|<0.0001
74017728|NCT00848354|147587190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.64|||<|0.0001|TWO_SIDED|95.0|3.74|15.63||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||15.63|3.74|<0.0001
74017729|NCT00848354|147587192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|2.04|4.86||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||4.86|2.04|<0.0001
74017730|NCT00848354|147587192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.85|6.82||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||6.82|2.85|<0.0001
74046358|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.45||0.007|TWO_SIDED|95.0|0.33|2.09|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.09|0.33|0.007
74046359|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.45||0.687|TWO_SIDED|95.0|-0.71|1.07|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.07|-0.71|0.687
74096383|NCT03589768|147742209|SUPERIORITY||Ratio|1.1||||0.7039|TWO_SIDED|95.0|0.8|1.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.4|0.8|0.7039
74017731|NCT00848354|147587192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.99|||<|0.0001|TWO_SIDED|95.0|2.5|6.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||6.38|2.50|<0.0001
74017732|NCT00848354|147587192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.37|6.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.41|2.37|<0.0001
74017733|NCT00848354|147587192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58|||<|0.0001|TWO_SIDED|95.0|3.19|9.76||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||9.76|3.19|<0.0001
74017734|NCT00848354|147587192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.49|||<|0.0001|TWO_SIDED|95.0|3.16|9.52||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||9.52|3.16|<0.0001
74017735|NCT00848354|147587192|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.87|11.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.21|3.87|<0.0001
74017736|NCT00848354|147587194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.3|5.4||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.40|2.30|<0.0001
74017737|NCT00848354|147587194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87|||<|0.0001|TWO_SIDED|95.0|3.07|7.71||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.71|3.07|<0.0001
74017738|NCT00848354|147587194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.0001|TWO_SIDED|95.0|2.98|8.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.41|2.98|<0.0001
74017739|NCT00848354|147587194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.55|7.58||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||7.58|2.55|<0.0001
74017740|NCT00848354|147587194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.81|||<|0.0001|TWO_SIDED|95.0|3.15|10.74||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||10.74|3.15|<0.0001
74096384|NCT03589768|147742209|SUPERIORITY||Ratio|18.5|||<|0.0001|TWO_SIDED|95.0|14.0|24.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|24.3|14.0|<0.0001
74096385|NCT03589768|147742209|SUPERIORITY||Ratio|10.5|||<|0.0001|TWO_SIDED|95.0|8.1|13.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|13.7|8.1|<0.0001
74017741|NCT00848354|147587194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18|||<|0.0001|TWO_SIDED|95.0|3.25|11.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||11.73|3.25|<0.0001
74017742|NCT00848354|147587194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.45|||<|0.0001|TWO_SIDED|95.0|3.67|11.33||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.33|3.67|<0.0001
74017743|NCT00848354|147587196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.09||||0.0349|TWO_SIDED|95.0|1.05|9.13||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||9.13|1.05|0.0349
74017744|NCT00848354|147587196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87|||<|0.0001|TWO_SIDED|95.0|1.98|7.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.60|1.98|<0.0001
74017745|NCT00848354|147587196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.1|5.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.88|2.10|<0.0001
74017746|NCT00848354|147587196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.0001|TWO_SIDED|95.0|2.02|5.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.06|2.02|<0.0001
74017747|NCT00848354|147587196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.78|6.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.96|2.78|<0.0001
74017748|NCT00848354|147587196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.8|6.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.90|2.80|<0.0001
74017749|NCT00848354|147587196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.13|||<|0.0001|TWO_SIDED|95.0|3.82|9.85||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||9.85|3.82|<0.0001
74017750|NCT00848354|147587198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.25|||<|0.0001|TWO_SIDED|95.0|2.74|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||6.60|2.74|<0.0001
74017751|NCT00848354|147587198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.6|||<|0.0001|TWO_SIDED|95.0|2.94|7.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.18|2.94|<0.0001
74017752|NCT00848354|147587198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21|||<|0.0001|TWO_SIDED|95.0|3.15|8.61||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.61|3.15|<0.0001
74017753|NCT00848354|147587198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.77|||<|0.0001|TWO_SIDED|95.0|3.36|9.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||9.93|3.36|<0.0001
74017754|NCT00848354|147587198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.15|||<|0.0001|TWO_SIDED|95.0|3.91|13.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.09|3.91|<0.0001
74017755|NCT00848354|147587198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.43|||<|0.0001|TWO_SIDED|95.0|4.5|15.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||15.80|4.50|<0.0001
74017756|NCT00848354|147587198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.05|||<|0.0001|TWO_SIDED|95.0|3.5|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||10.47|3.50|<0.0001
74017757|NCT00848354|147587200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.4||||0.025|TWO_SIDED|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||56.88|0.96|0.0250
74017758|NCT00848354|147587200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0466|TWO_SIDED|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.45|1.00|0.0466
74096386|NCT03589768|147742209|SUPERIORITY||Ratio|7.4|||<|0.0001|TWO_SIDED|95.0|5.0|11.1|||t-test, 2 sided|Difference in log values back transformed into ratio.||Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|11.1|5.0|<0.0001
74096387|NCT03589768|147742210|SUPERIORITY||Ratio|1.2||||0.2897|TWO_SIDED|95.0|0.8|1.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.8|0.8|0.2897
74096388|NCT03589768|147742210|SUPERIORITY||Ratio|54.2|||<|0.0001|TWO_SIDED|95.0|35.6|82.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|82.4|35.6|<0.0001
73880619|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0029|TWO_SIDED|95.0|1.76|15.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.78|1.76|0.0029
73888074|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0||||0.8136|TWO_SIDED|95.0|-51.4|65.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||65.4|-51.4|0.8136
74046360|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|0.89|STANDARD_ERROR_OF_MEAN|0.45||0.05|TWO_SIDED|95.0|0.0|1.78|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-0.00|0.050
74046361|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.48||0.215|TWO_SIDED|95.0|-0.35|1.54|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.54|-0.35|0.215
74046362|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|0.96|STANDARD_ERROR_OF_MEAN|0.47||0.042|TWO_SIDED|95.0|0.03|1.89|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.89|0.03|0.042
74046363|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.5||0.401|TWO_SIDED|95.0|-1.41|0.56|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.56|-1.41|0.401
74046364|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.5||0.98|TWO_SIDED|95.0|-0.96|0.99|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.99|-0.96|0.980
74046365|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.51||0.632|TWO_SIDED|95.0|-1.25|0.76|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.76|-1.25|0.632
74046366|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|1.08|STANDARD_ERROR_OF_MEAN|0.51||0.032|TWO_SIDED|95.0|0.09|2.07|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.07|0.09|0.032
74046367|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.54||0.668|TWO_SIDED|95.0|-1.29|0.83|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.83|-1.29|0.668
74046368|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|0.54||0.038|TWO_SIDED|95.0|0.06|2.16|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.16|0.06|0.038
74096389|NCT03589768|147742210|SUPERIORITY||Ratio|32.0|||<|0.0001|TWO_SIDED|95.0|20.6|49.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|49.7|20.6|<0.0001
74096390|NCT03589768|147742210|SUPERIORITY||Ratio|18.9|||<|0.0001|TWO_SIDED|95.0|10.4|34.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|34.2|10.4|<0.0001
74096391|NCT03589768|147742211|SUPERIORITY||Ratio|1.0||||0.837|TWO_SIDED|95.0|0.6|1.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.5|0.6|0.8370
74017759|NCT00848354|147587200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0007|TWO_SIDED|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.36|1.50|0.0007
74017760|NCT00848354|147587200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.0001|TWO_SIDED|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.18|1.70|<0.0001
74017761|NCT00848354|147587200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||5.05|1.85|<0.0001
74017762|NCT00848354|147587200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.87|2.47|<0.0001
74017763|NCT00848354|147587200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.51|||<|0.0001|TWO_SIDED|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.38|3.72|<0.0001
74017764|NCT00848354|147587202|SUPERIORITY_OR_OTHER|||||||0.3054||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||||0.3054
74096392|NCT03589768|147742211|SUPERIORITY||Ratio|0.6|||<|0.0001|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.8|0.5|<0.0001
74096393|NCT03589768|147742211|SUPERIORITY||Ratio|0.7||||0.005|TWO_SIDED|95.0|0.6|0.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.9|0.6|0.0050
74096394|NCT03589768|147742211|SUPERIORITY||Ratio|0.8||||0.0689|TWO_SIDED|95.0|0.6|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.6|0.0689
74096395|NCT03589768|147742212|SUPERIORITY||Ratio|1.0||||0.8361|TWO_SIDED|95.0|0.7|1.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.6|0.7|0.8361
74017765|NCT00848354|147587202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.4044|TWO_SIDED|95.0|0.58|7.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.53|0.58|0.4044
74017766|NCT00848354|147587202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53||||0.0388|TWO_SIDED|95.0|1.02|6.26||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||6.26|1.02|0.0388
74017767|NCT00848354|147587202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.89||||0.0059|TWO_SIDED|95.0|1.31|6.34||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.34|1.31|0.0059
74017768|NCT00848354|147587202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3|||<|0.0001|TWO_SIDED|95.0|1.99|9.29||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||9.29|1.99|<0.0001
74017769|NCT00848354|147587202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|2.88|12.24||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||12.24|2.88|<0.0001
74017770|NCT00848354|147587202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.18|||<|0.0001|TWO_SIDED|95.0|3.61|23.32||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||23.32|3.61|<0.0001
74017771|NCT00848354|147587204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.4||||0.025|TWO_SIDED|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||56.88|0.96|0.0250
74096396|NCT03589768|147742212|SUPERIORITY||Ratio|0.9||||0.5136|TWO_SIDED|95.0|0.6|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.6|0.5136
74096397|NCT03589768|147742212|SUPERIORITY||Ratio|0.9||||0.4237|TWO_SIDED|95.0|0.6|1.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.2|0.6|0.4237
74096398|NCT03589768|147742212|SUPERIORITY||Ratio|0.7||||0.1607|TWO_SIDED|95.0|0.4|1.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.2|0.4|0.1607
74096399|NCT03589768|147742213|SUPERIORITY||Ratio|13.7|||<|0.0001|TWO_SIDED|95.0|10.2|18.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|18.3|10.2|<0.0001
74096400|NCT03589768|147742213|SUPERIORITY||Ratio|10.8|||<|0.0001|TWO_SIDED|95.0|8.0|14.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|14.5|8.0|<0.0001
74096401|NCT03589768|147742213|SUPERIORITY||Ratio|10.2|||<|0.0001|TWO_SIDED|95.0|6.9|15.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio. Test compares difference in log values.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|15.2|6.9|<0.0001
74096402|NCT03589768|147742213|SUPERIORITY||Ratio|2.1||||0.0002|TWO_SIDED|95.0|1.4|3.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|3.0|1.4|0.0002
74096403|NCT03589768|147742213|SUPERIORITY||Ratio|1.2||||0.4828|TWO_SIDED|95.0|0.8|1.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.7|0.8|0.4828
74096404|NCT03589768|147742214|SUPERIORITY||Ratio|46.4|||<|0.0001|TWO_SIDED|95.0|26.6|81.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|81.0|26.6|<0.0001
74096405|NCT03589768|147742214|SUPERIORITY||Ratio|39.5|||<|0.0001|TWO_SIDED|95.0|24.0|65.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|65.0|24.0|<0.0001
74096406|NCT03589768|147742214|SUPERIORITY||Ratio|10.4|||<|0.0001|TWO_SIDED|95.0|6.1|17.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|17.9|6.1|<0.0001
74096407|NCT03589768|147742214|SUPERIORITY||Ratio|0.6||||0.0746|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.3|0.0746
74017772|NCT00848354|147587204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0466|TWO_SIDED|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.45|1.00|0.0466
74096408|NCT03589768|147742214|SUPERIORITY||Ratio|0.7||||0.1532|TWO_SIDED|95.0|0.5|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.5|0.1532
74096409|NCT03589768|147742215|SUPERIORITY||Ratio|0.7||||0.0022|TWO_SIDED|95.0|0.6|0.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.9|0.6|0.0022
74096410|NCT03589768|147742215|SUPERIORITY||Ratio|0.7||||0.0008|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.8|0.5|0.0008
74096411|NCT03589768|147742215|SUPERIORITY||Ratio|0.7||||0.0261|TWO_SIDED|95.0|0.5|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.5|0.0261
74096412|NCT03589768|147742215|SUPERIORITY||Ratio|0.6||||0.0532|TWO_SIDED|95.0|0.3|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.3|0.0532
74096413|NCT03589768|147742215|SUPERIORITY||Ratio|0.9||||0.5587|TWO_SIDED|95.0|0.5|1.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.4|0.5|0.5587
74096414|NCT03589768|147742216|SUPERIORITY||Ratio|0.9||||0.5056|TWO_SIDED|95.0|0.6|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.6|0.5056
74096415|NCT03589768|147742216|SUPERIORITY||Ratio|1.0||||0.9466|TWO_SIDED|95.0|0.7|1.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.5|0.7|0.9466
74046369|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.53||0.868|TWO_SIDED|95.0|-1.13|0.95|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.95|-1.13|0.868
74096416|NCT03589768|147742216|SUPERIORITY||Ratio|1.1||||0.6911|TWO_SIDED|95.0|0.6|2.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.0|0.6|0.6911
74096417|NCT03589768|147742216|SUPERIORITY||Ratio|0.6||||0.0952|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.3|0.0952
74096418|NCT03589768|147742216|SUPERIORITY||Ratio|1.2||||0.4134|TWO_SIDED|95.0|0.8|2.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.0|0.8|0.4134
74096419|NCT03589768|147742217|SUPERIORITY||Ratio|1.6||||0.0859|TWO_SIDED|95.0|0.9|2.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.6|0.9|0.0859
74096420|NCT03589768|147742217|SUPERIORITY||Ratio|1.4||||0.204|TWO_SIDED|95.0|0.8|2.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.3|0.8|0.2040
74046370|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|0.59|STANDARD_ERROR_OF_MEAN|0.52||0.257|TWO_SIDED|95.0|-0.43|1.62|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.62|-0.43|0.257
74046371|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.55||0.895|TWO_SIDED|95.0|-1.0|1.15|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.15|-1.00|0.895
74096421|NCT03589768|147742217|SUPERIORITY||Ratio|1.6||||0.0763|TWO_SIDED|95.0|1.0|2.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.7|1.0|0.0763
74096422|NCT03589768|147742217|SUPERIORITY||Ratio|0.5||||0.0836|TWO_SIDED|95.0|0.2|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.2|0.0836
74096423|NCT03589768|147742217|SUPERIORITY||Ratio|0.6||||0.0672|TWO_SIDED|95.0|0.3|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.3|0.0672
74096424|NCT02213510|147742232|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
74096425|NCT02213510|147742233|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED||||||t-test, 2 sided|||||||0.655
74096426|NCT02213510|147742234|SUPERIORITY_OR_OTHER|||||||0.811|TWO_SIDED||||||t-test, 2 sided|||||||0.811
74096427|NCT02213510|147742235|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||||||1.00
74096428|NCT02213510|147742236|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||t-test, 2 sided|||||||0.462
74096429|NCT02213510|147742237|SUPERIORITY_OR_OTHER|||||||0.646|TWO_SIDED||||||t-test, 2 sided|||||||0.646
74096430|NCT02213510|147742238|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||||||0.510
74096431|NCT02213510|147742239|SUPERIORITY_OR_OTHER|||||||0.651|TWO_SIDED||||||t-test, 2 sided|||||||0.651
74096432|NCT02213510|147742240|SUPERIORITY_OR_OTHER|||||||0.588|TWO_SIDED||||||t-test, 2 sided|||||||0.588
74096433|NCT02213510|147742241|SUPERIORITY_OR_OTHER|||||||0.858|TWO_SIDED||||||t-test, 2 sided|||||||0.858
74096434|NCT02213510|147742242|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||||||1.00
74096435|NCT03786718|147742269|OTHER||||||<|0.001|||||||One sample median test|||Due to nonnormality, we used nonparametric tests to analyze the data. This analysis is a one sample median test of participants' median SUS score compared to the threshold score of 68 indicative of 'above average' usability.||||<0.001
74096436|NCT03786718|147742273|OTHER|||||||0.77|||||||Wilcoxon Signed Rank Sum test|||||||0.77
74096437|NCT03786718|147742274|OTHER|||||||0.02|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in General Diet sub-scale score||||0.02
74096438|NCT03786718|147742274|OTHER|||||||0.13|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Specific Diet sub-scale score||||0.13
74096439|NCT03786718|147742274|OTHER|||||||0.35|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Exercise sub-scale score||||0.35
74096440|NCT03786718|147742274|OTHER|||||||0.67|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Blood-glucose Testing sub-scale score||||0.67
74096441|NCT03786718|147742274|OTHER|||||||0.65|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Foot Care sub-scale score||||0.65
74096442|NCT03786718|147742275|OTHER|||||||0.001|||||||Wilcoxon Signed Rank Sum test|||||||0.001
74096443|NCT03786718|147742276|OTHER|||||||0.86|||||||Wilcoxon Signed Rank Sum test|||||||0.86
74096444|NCT03786718|147742277|OTHER|||||||0.3|||||||McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||0.30
73880620|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|5.95||||0.0011|TWO_SIDED|95.0|2.03|17.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||17.40|2.03|0.0011
74017773|NCT00848354|147587204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0007|TWO_SIDED|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.36|1.50|0.0007
74096445|NCT03786718|147742277|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||1.00
73880621|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9511|TWO_SIDED|95.0|0.29|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.23|0.29|0.9511
74017774|NCT00848354|147587204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.0001|TWO_SIDED|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.18|1.70|<0.0001
74017775|NCT00848354|147587204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||5.05|1.85|<0.0001
74017776|NCT00848354|147587204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.87|2.47|<0.0001
74017777|NCT00848354|147587204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.51|||<|0.0001|TWO_SIDED|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.38|3.72|<0.0001
74017778|NCT00848354|147587206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.0001|TWO_SIDED|95.0|2.9|7.07||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||7.07|2.90|<0.0001
74017779|NCT00848354|147587206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.36|6.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||6.80|2.36|<0.0001
74017780|NCT00848354|147587206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23|||<|0.0001|TWO_SIDED|95.0|2.82|9.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||9.72|2.82|<0.0001
74017781|NCT00848354|147587206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.25|||<|0.0001|TWO_SIDED|95.0|2.63|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||10.47|2.63|<0.0001
74017782|NCT00848354|147587206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.53|||<|0.0001|TWO_SIDED|95.0|3.16|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.48|3.16|<0.0001
74017783|NCT00848354|147587206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.38|||<|0.0001|TWO_SIDED|95.0|3.86|18.17||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||18.17|3.86|<0.0001
74017784|NCT00848354|147587206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.84|||<|0.0001|TWO_SIDED|95.0|3.94|15.62||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||15.62|3.94|<0.0001
74017785|NCT00848354|147587208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.35|5.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.73|2.35|<0.0001
74017786|NCT00848354|147587208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.65|||<|0.0001|TWO_SIDED|95.0|3.0|7.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.22|3.00|<0.0001
74017787|NCT00848354|147587208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96|||<|0.0001|TWO_SIDED|95.0|3.05|8.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.06|3.05|<0.0001
74017788|NCT00848354|147587208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.34|||<|0.0001|TWO_SIDED|95.0|3.18|8.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||8.96|3.18|<0.0001
74096446|NCT03786718|147742277|OTHER|||||||0.63|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.63
74096447|NCT03786718|147742277|OTHER|||||||0.02|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.02
74096448|NCT03786718|147742277|OTHER|||||||0.55|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.55
74096449|NCT03786718|147742277|OTHER|||||||0.0009|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.0009
73880622|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.76||||0.3241|TWO_SIDED|95.0|0.57|5.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.45|0.57|0.3241
73880623|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0111|TWO_SIDED|95.0|1.36|11.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||11.16|1.36|0.0111
73880624|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|2.51||||0.1375|TWO_SIDED|95.0|0.74|8.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.48|0.74|0.1375
74017789|NCT00848354|147587208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.7|||<|0.0001|TWO_SIDED|95.0|3.23|10.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||10.06|3.23|<0.0001
74096450|NCT03786718|147742277|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of flu vaccine||||1.00
74096451|NCT03786718|147742277|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of recommended frequency of flu vaccination||||1.00
74096452|NCT03786718|147742278|OTHER|||||||0.15|||||||Wilcoxon Signed Rank Sum test|||||||0.15
74096453|NCT03786718|147742279|OTHER|||||||0.23|||||||McNemar|||Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)||||0.23
74017790|NCT00848354|147587208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.88|||<|0.0001|TWO_SIDED|95.0|4.37|14.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||14.20|4.37|<0.0001
74017791|NCT00848354|147587208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.73|||<|0.0001|TWO_SIDED|95.0|3.4|9.65||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||9.65|3.40|<0.0001
74096454|NCT03786718|147742279|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)||||1.00
74017792|NCT00848354|147587210|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
74096455|NCT03786718|147742279|OTHER|||||||0.51|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me \[social comparison information\] is useful.'||||0.51
74096456|NCT03786718|147742279|OTHER|||||||0.63|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range \[goal-based comparison information\] is useful.||||0.63
74096457|NCT03786718|147742280|OTHER|||||||0.01|||||||Wilcoxon Signed Rank Sum test|||||||0.01
73880625|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.02||||0.067|TWO_SIDED|95.0|0.93|9.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.83|0.93|0.0670
73880626|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|7.57||||0.0009|TWO_SIDED|95.0|2.29|25.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||25.04|2.29|0.0009
74017793|NCT00848354|147587212|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
74096458|NCT00945100|147742284|SUPERIORITY_OR_OTHER||Risk difference (unadjusted)|22.0||||0.003|TWO_SIDED|95.0|8.0|35.0|||Regression, Logistic|The logistic regression model included amblyopic eye visual acuity at randomization as an adjustment covariate.||||35|8|0.003
74096459|NCT00945100|147742285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.01|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|The ANCOVA model included interocular difference at randomization as an adjustment covariate.||||1.0|0.1|0.01
74096460|NCT00945100|147742287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.002|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.||1.0|0.3|0.002
74096461|NCT00945100|147742291|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within gender was assessed by including an interaction term between treatment group and gender in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.04
74096462|NCT00945100|147742291|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within race/ethnicity was assessed by including an interaction term between treatment group and race/ethnicity in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.89
74017794|NCT00848354|147587214|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
74096463|NCT00945100|147742291|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within age at randomization was assessed by including an interaction term between treatment group and age in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.49
74096464|NCT00945100|147742291|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANCOVA|||The treatment effect within amblyopic eye visual acuity at randomization was assessed by including an interaction term between treatment group and visual acuity in the ANCOVA model, adjusting for the main effects corresponding to the interaction term.||||0.37
74096465|NCT00945100|147742291|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within cause of amblyopia was assessed by including an interaction term between treatment group and amblyopia cause in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.50
74096466|NCT00945100|147742293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|0.04|1.0|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||||1.0|0.04|
73880627|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|9.42||||0.0002|TWO_SIDED|95.0|2.91|30.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||30.49|2.91|0.0002
74017795|NCT00848354|147587216|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
74096467|NCT00945100|147742301|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the 10-week exam.||||>0.99
74017796|NCT00848354|147587218|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.||||<0.0001
74096468|NCT00945100|147742303|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the final exam.||||0.12
74096469|NCT00945100|147742307|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.||||0.28
74096470|NCT00945100|147742310|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.||||0.45
74096471|NCT05958888|147742311|SUPERIORITY||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<0.001
74096472|NCT05958888|147742311|SUPERIORITY||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome.The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<0.001
74096473|NCT05958888|147742311|SUPERIORITY||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
74096474|NCT05958888|147742311|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.10
74017797|NCT00848354|147587218|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.||||0.0007
74046372|NCT00565812|147644920|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.54||0.268|TWO_SIDED|95.0|-0.46|1.67|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.67|-0.46|0.268
74046373|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.44||0.908|TWO_SIDED|95.0|-0.92|0.82|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.82|-0.92|0.908
74046374|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.44||0.008|TWO_SIDED|95.0|-2.05|-0.31|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.31|-2.05|0.008
74046375|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.46||0.44|TWO_SIDED|95.0|-1.25|0.54|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.54|-1.25|0.440
73880628|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0982|TWO_SIDED|95.0|0.83|9.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.14|0.83|0.0982
74017798|NCT00848354|147587218|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0009
74017799|NCT00848354|147587218|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.||||0.0007
74017800|NCT00848354|147587218|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0005
74017801|NCT00848354|147587218|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.||||<0.0001
74017802|NCT00848354|147587218|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
74017803|NCT00848354|147587220|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
74046376|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.46||0.14|TWO_SIDED|95.0|-1.57|0.22|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.22|-1.57|0.140
74017804|NCT00848354|147587222|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
74017805|NCT00848354|147587224|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
74017806|NCT00848354|147587226|SUPERIORITY_OR_OTHER|||||||0.1975|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||0.1975
73880629|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1233|TWO_SIDED|95.0|0.77|8.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.80|0.77|0.1233
74017807|NCT00848354|147587227|SUPERIORITY_OR_OTHER|||||||0.0044|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||0.0044
74017808|NCT00848354|147587228|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
74096475|NCT05958888|147742311|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.01
74096476|NCT05958888|147742311|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.2||0.25|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.25
74017809|NCT00848354|147587230|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.||||<0.0001
74017810|NCT00848354|147587230|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.||||<0.0001
74017811|NCT00848354|147587230|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0002
74017812|NCT00848354|147587230|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.||||0.0007
74017813|NCT00848354|147587230|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0001
74017814|NCT00848354|147587230|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.||||<0.0001
74017815|NCT00848354|147587230|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0021
74017816|NCT00848354|147587231|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0001
74017817|NCT00848354|147587231|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
74017818|NCT00848354|147587231|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0003
74017819|NCT00848354|147587233|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
74017820|NCT00848354|147587233|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0264
74096477|NCT05958888|147742312|SUPERIORITY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
73880630|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|4.63||||0.0091|TWO_SIDED|95.0|1.46|14.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||14.64|1.46|0.0091
73880631|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.03||||0.962|TWO_SIDED|95.0|0.34|3.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.10|0.34|0.9620
74096478|NCT05958888|147742312|SUPERIORITY||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
74096479|NCT05958888|147742312|SUPERIORITY||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
74046377|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.46||0.474|TWO_SIDED|95.0|-0.58|1.24|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.24|-0.58|0.474
74046378|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.46||0.376|TWO_SIDED|95.0|-1.32|0.5|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.50|-1.32|0.376
74046379|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|0.66|STANDARD_ERROR_OF_MEAN|0.5||0.186|TWO_SIDED|95.0|-0.32|1.64|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.64|-0.32|0.186
74046380|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.5||0.185|TWO_SIDED|95.0|-1.63|0.32|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.32|-1.63|0.185
74046381|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.52||0.334|TWO_SIDED|95.0|-1.53|0.52|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.52|-1.53|0.334
74046382|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.52||0.055|TWO_SIDED|95.0|-2.0|0.02|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.02|-2.00|0.055
74096480|NCT05958888|147742312|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.85||0.12|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.12
74096481|NCT05958888|147742312|SUPERIORITY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||<.001
74017821|NCT00848354|147587233|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0002
74017822|NCT00848354|147587235|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0005
74017823|NCT00848354|147587235|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
74017824|NCT00848354|147587235|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
73888075|NCT01746901|147309533|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.6||||0.6699|TWO_SIDED|95.0|-71.0|45.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.7|-71.0|0.6699
74017825|NCT00848354|147587237|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 8, Week 16, and Week 24 - independently).||||<0.0001
74017826|NCT00848354|147587238|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0061
74046383|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.54||0.539|TWO_SIDED|95.0|-1.38|0.72|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.72|-1.38|0.539
74046384|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.53||0.018|TWO_SIDED|95.0|-2.3|-0.22|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.22|-2.30|0.018
74046385|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.53||0.365|TWO_SIDED|95.0|-1.52|0.56|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.56|-1.52|0.365
74046386|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.52||0.403|TWO_SIDED|95.0|-1.47|0.59|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.59|-1.47|0.403
74046387|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.57||0.02|TWO_SIDED|95.0|-2.43|-0.21|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.21|-2.43|0.020
74046388|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-2.98|-0.77|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.77|-2.98|<0.001
74046389|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.269|TWO_SIDED|95.0|-1.66|0.46|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.46|-1.66|0.269
74096482|NCT05958888|147742312|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.85||0.04|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.04
74096483|NCT05958888|147742313|SUPERIORITY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||.01
74046390|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.54||0.104|TWO_SIDED|95.0|-1.92|0.18|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.18|-1.92|0.104
74096484|NCT05958888|147742313|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.23|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||.23
73880632|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3527|TWO_SIDED|95.0|0.58|4.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.59|0.58|0.3527
74096485|NCT05958888|147742313|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||.01
74017827|NCT00848354|147587238|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0730
74017828|NCT00848354|147587238|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
74096486|NCT05958888|147742313|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.58
74096487|NCT05958888|147742313|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.85|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.85
74096488|NCT05958888|147742313|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.58
74096489|NCT05958888|147742314|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||>.99
74096490|NCT05958888|147742314|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||>.99
74096491|NCT05958888|147742314|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.47|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||.47
74096492|NCT05958888|147742314|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||>.99
74096493|NCT05958888|147742314|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.1||0.45|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.45
74096494|NCT05958888|147742314|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.7|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.70
74096495|NCT05958888|147742315|SUPERIORITY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
74017829|NCT00848354|147587239|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0066
74017830|NCT00848354|147587239|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0036
74017831|NCT00848354|147587239|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
74017832|NCT00848354|147587240|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
74017833|NCT00848354|147587240|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0013
74017834|NCT00848354|147587240|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0002
74017835|NCT00848354|147587241|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0021
74017836|NCT00848354|147587241|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
74017837|NCT00848354|147587241|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
74017838|NCT00848354|147587242|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0062
74017839|NCT00848354|147587242|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0007
74017840|NCT00848354|147587242|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
74017841|NCT00848354|147587243|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
74017842|NCT00848354|147587243|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0073
74017843|NCT00848354|147587243|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
74017844|NCT05064059|147587248|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4183|TWO_SIDED|95.0|0.8|1.2||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.20|0.80|0.4183
74017845|NCT05064059|147587249|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.9967|TWO_SIDED|95.0|1.09|1.64||One-sided nominal p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.64|1.09|0.9967
74017846|NCT05064059|147587250|SUPERIORITY||Difference in percentage|5.9||||0.0007|TWO_SIDED|95.0|2.5|10.1||One-sided, nominal p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen Method||Difference in percentage and 95% CI were based on the Miettinen \& Nurminen method stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||10.1|2.5|0.0007
74017847|NCT05064059|147587254|OTHER||Difference in Least Square (LS) Means|-3.08||||0.1318|TWO_SIDED|95.0|-7.09|0.93||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||0.93|-7.09|0.1318
74017848|NCT05064059|147587255|OTHER||Difference in LS Means|-0.95||||0.637|TWO_SIDED|95.0|-4.93|3.02||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||3.02|-4.93|0.6370
74017849|NCT05064059|147587256|OTHER||Difference in LS Means|3.86||||0.1846|TWO_SIDED|95.0|-1.85|9.57||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||9.57|-1.85|0.1846
74017850|NCT05064059|147587257|OTHER||Difference in LS Means|0.56||||0.841|TWO_SIDED|95.0|-4.96|6.08||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||6.08|-4.96|0.8410
74017851|NCT05064059|147587258|OTHER||Hazard Ratio (HR)|1.0||||0.5094|TWO_SIDED|95.0|0.64|1.58||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.58|0.64|0.5094
74096496|NCT05958888|147742315|SUPERIORITY||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
74096497|NCT05958888|147742315|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
74017852|NCT05064059|147587259|OTHER||Hazard Ratio (HR)|1.51||||0.9704|TWO_SIDED|95.0|0.98|2.33||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||2.33|0.98|0.9704
74017853|NCT05064059|147587260|OTHER||Hazard Ratio (HR)|1.82||||0.9905|TWO_SIDED|95.0|1.11|2.98||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||2.98|1.11|0.9905
74017854|NCT05064059|147587261|OTHER||Hazard Ratio (HR)|1.86||||0.9853|TWO_SIDED|95.0|1.06|3.26||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization|||3.26|1.06|0.9853
74017855|NCT04669678|147587262|OTHER||Odds Ratio (OR)|0.85||||0.306|TWO_SIDED|90.0|0.65|1.11|||Mixed Models Analysis|||Week 2||1.11|0.65|0.306
74017856|NCT04669678|147587262|OTHER||Odds Ratio (OR)|0.81||||0.874|TWO_SIDED|90.0|0.6|1.09|||Mixed Models Analysis|||Week 4||1.09|0.60|0.874
74017857|NCT04669678|147587262|OTHER||Odds Ratio (OR)|1.04||||0.646|TWO_SIDED|90.0|0.91|1.19|||Mixed Models Analysis|||Week 8||1.19|0.91|0.646
74017858|NCT04669678|147587262|OTHER||Odds Ratio (OR)|1.02||||0.869|TWO_SIDED|90.0|0.82|1.28|||Mixed Models Analysis|||Week 12||1.28|0.82|0.869
74017859|NCT04669678|147587262|OTHER||Odds Ratio (OR)|0.51||||0.044|TWO_SIDED|90.0|0.3|0.88|||Mixed Models Analysis|||Week 2||0.88|0.30|0.044
74017860|NCT04669678|147587262|OTHER||Odds Ratio (OR)|0.36|||<|0.001|TWO_SIDED|90.0|0.28|0.46|||Mixed Models Analysis|||Week 4||0.46|0.28|<0.001
74017861|NCT04669678|147587262|OTHER||Odds Ratio (OR)|0.37|||<|0.001|TWO_SIDED|90.0|0.27|0.49|||Mixed Models Analysis|||Week 8||0.49|0.27|<0.001
74017862|NCT04669678|147587262|OTHER||Odds Ratio (OR)|0.44|||<|0.001|TWO_SIDED|90.0|0.35|0.54|||Mixed Models Analysis|||Week 12||0.54|0.35|<0.001
74017863|NCT04669678|147587263|OTHER||Odds Ratio (OR)|1.25||||0.641|TWO_SIDED|90.0|0.57|2.74|||Mixed Models Analysis|||Week 2||2.74|0.57|0.641
74017864|NCT04669678|147587263|OTHER||Odds Ratio (OR)|1.57||||0.204|TWO_SIDED|90.0|0.87|2.8|||Mixed Models Analysis|||Week 4||2.80|0.87|0.204
74017865|NCT04669678|147587263|OTHER||Odds Ratio (OR)|1.29||||0.415|TWO_SIDED|90.0|0.77|2.15|||Mixed Models Analysis|||Week 8||2.15|0.77|0.415
74017866|NCT04669678|147587263|OTHER||Odds Ratio (OR)|2.23||||0.027|TWO_SIDED|90.0|1.23|4.06|||Mixed Models Analysis|||Week 12||4.06|1.23|0.027
74017867|NCT04669678|147587263|OTHER||Odds Ratio (OR)|1.86||||0.274|TWO_SIDED|90.0|0.73|4.73|||Mixed Models Analysis|||Week 2||4.73|0.73|0.274
74017868|NCT04669678|147587263|OTHER||Odds Ratio (OR)|1.83||||0.065|TWO_SIDED|90.0|1.07|3.13|||Mixed Models Analysis|||Week 4||3.13|1.07|0.065
74017869|NCT04669678|147587263|OTHER||Odds Ratio (OR)|1.72||||0.252|TWO_SIDED|90.0|0.79|3.75|||Mixed Models Analysis|||Week 8||3.75|0.79|0.252
74017870|NCT04669678|147587263|OTHER||Odds Ratio (OR)|2.61||||0.002|TWO_SIDED|90.0|1.57|4.33|||Mixed Models Analysis|||Week 12||4.33|1.57|0.002
74017871|NCT04669678|147587263|OTHER||Odds Ratio (OR)|0.78||||0.46|TWO_SIDED|90.0|0.46|1.34|||Mixed Models Analysis|||Week 20||1.34|0.46|0.460
74017872|NCT04669678|147587263|OTHER||Odds Ratio (OR)|1.59||||0.019|TWO_SIDED|90.0|1.15|2.2|||Mixed Models Analysis|||Week 24||2.20|1.15|0.019
74017873|NCT04669678|147587263|OTHER||Odds Ratio (OR)|2.16||||0.061|TWO_SIDED|90.0|1.1|4.27|||Mixed Models Analysis|||Week 2||4.27|1.10|0.061
74017874|NCT04669678|147587263|OTHER||Odds Ratio (OR)|1.64||||0.106|TWO_SIDED|90.0|0.99|2.71|||Mixed Models Analysis|||Week 4||2.71|0.99|0.106
74017875|NCT04669678|147587263|OTHER||Odds Ratio (OR)|1.77||||0.144|TWO_SIDED|90.0|0.93|3.36|||Mixed Models Analysis|||Week 8||3.36|0.93|0.144
74017876|NCT04669678|147587263|OTHER||Odds Ratio (OR)|2.37||||0.011|TWO_SIDED|90.0|1.36|4.16|||Mixed Models Analysis|||Week 12||4.16|1.36|0.011
74017877|NCT05227690|147587265|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24|=|0.1765|TWO_SIDED|95.0|-7.5|1.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||1.4|-7.5|=0.1765
74096498|NCT05958888|147742315|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||<.001
74096499|NCT05958888|147742315|SUPERIORITY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||<.001
74017878|NCT05227690|147587265|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.26|=|0.6007|TWO_SIDED|95.0|-5.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Emraclidine 10 mg versus Placebo||3.3|-5.6|=0.6007
74017879|NCT05227690|147587266|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124|=|0.2534|TWO_SIDED|95.0|-0.39|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||0.10|-0.39|=0.2534
74017880|NCT05227690|147587266|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.125|=|0.6774|TWO_SIDED|95.0|-0.3|0.19|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Emraclidine 10 mg versus Placebo||0.19|-0.30|=0.6774
74017881|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.1|=|0.3596|TWO_SIDED|95.0|-3.2|1.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||1.2|-3.2|=0.3596
74017882|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.1|=|0.6053|TWO_SIDED|95.0|-2.7|1.6|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 1-- Emraclidine 10 mg versus Placebo||1.6|-2.7|=0.6053
74017883|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.54|=|0.8149|TWO_SIDED|95.0|-3.4|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||2.7|-3.4|=0.8149
74017884|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.55|=|0.9058|TWO_SIDED|95.0|-3.2|2.9|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 2-- Emraclidine 10 mg versus Placebo||2.9|-3.2|=0.9058
74017885|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.71|=|0.5419|TWO_SIDED|95.0|-4.4|2.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||2.3|-4.4|=0.5419
74017886|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.72|=|0.8585|TWO_SIDED|95.0|-3.1|3.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||3.7|-3.1|=0.8585
74017887|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.99|=|0.5521|TWO_SIDED|95.0|-5.1|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||2.7|-5.1|=0.5521
74017888|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|2.0|=|0.754|TWO_SIDED|95.0|-4.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 4-- Emraclidine 10 mg versus Placebo||3.3|-4.6|=0.7540
74017889|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.12|=|0.4842|TWO_SIDED|95.0|-5.7|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 5-- Emraclidine 30 mg versus Placebo||2.7|-5.7|=0.4842
74096500|NCT05958888|147742315|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.72|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.72
74017890|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|2.13|=|0.6999|TWO_SIDED|95.0|-5.0|3.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 5-- Emraclidine 10 mg versus Placebo||3.4|-5.0|=0.6999
74017891|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24|=|0.1765|TWO_SIDED|95.0|-7.5|1.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||1.4|-7.5|=0.1765
74017892|NCT05227690|147587267|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.26|=|0.6007|TWO_SIDED|95.0|-5.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||3.3|-5.6|=0.6007
73880633|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.04||||0.0394|TWO_SIDED|95.0|1.06|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.76|1.06|0.0394
74017893|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.061|=|0.5822|TWO_SIDED|95.0|-0.15|0.09|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||0.09|-0.15|=0.5822
74046391|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.57||0.038|TWO_SIDED|95.0|-2.3|-0.06|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.06|-2.30|0.038
74046392|NCT00565812|147644921|SUPERIORITY_OR_OTHER||LS mean difference|-1.16|STANDARD_ERROR_OF_MEAN|0.57||0.041|TWO_SIDED|95.0|-2.28|-0.05|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.05|-2.28|0.041
74046393|NCT01810380|147644932|SUPERIORITY_OR_OTHER||Least square mean difference|-4.1|STANDARD_ERROR_OF_MEAN|2.1||0.056|TWO_SIDED|95.0|-8.2|0.1||For all efficacy analyses the primary comparison is the difference between brexpiprazole 2 to 4 mg/day and placebo at Week 6.|Mixed Models Analysis|Pooled site, visit, treatment as fixed effects, baseline score as continuous covariate, treatment-by-visit and baseline score-by-visit as interactions||The overall significance level was 0.05. The primary and the key secondary endpoints were tested hierarchically. Only if the primary endpoint was statistically significant would confirmatory testing continue with the key secondary endpoint.||0.1|-8.2|0.0560
74046394|NCT01810380|147644932|SUPERIORITY_OR_OTHER||Least square mean difference|-8.0|STANDARD_ERROR_OF_MEAN|2.1||0.0002|TWO_SIDED|95.0|-12.2|-3.9|||Mixed Models Analysis|||||-3.9|-12.2|0.0002
74046395|NCT03209362|147644995|SUPERIORITY||Least Squares Mean Difference|-2.9||||0.5453|TWO_SIDED|95.0|-12.4|6.6|||ANCOVA|||||6.6|-12.4|0.5453
74046396|NCT03209362|147644996|SUPERIORITY||Least Squares Mean Difference|-3.5||||0.5386|TWO_SIDED|95.0|-14.9|7.8|||Longitudinal model|||Week 12||7.8|-14.9|0.5386
74046397|NCT03209362|147644996|SUPERIORITY||Least Squares Mean Difference|-3.3||||0.5873|TWO_SIDED|95.0|-15.2|8.6|||Longitudinal model|||Week 26||8.6|-15.2|0.5873
74046398|NCT03209362|147644997|SUPERIORITY||Least Squares Mean Difference|-2.9||||0.6347|TWO_SIDED|95.0|-15.0|9.2|||Longitudinal model|||Week 12||9.2|-15.0|0.6347
74046399|NCT03209362|147644997|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.7806|TWO_SIDED|95.0|-14.3|10.8|||Longitudinal model|||Week 26||10.8|-14.3|0.7806
74046400|NCT03209362|147644998|SUPERIORITY||Least Squares Mean Difference|-0.9||||0.8819|TWO_SIDED|95.0|-13.2|11.4|||Longitudinal model|||Week 12||11.4|-13.2|0.8819
74046401|NCT03209362|147644998|SUPERIORITY||Least Squares Mean Difference|-5.6||||0.3796|TWO_SIDED|95.0|-18.3|7.1|||Longitudinal model|||Week 26||7.1|-18.3|0.3796
74046402|NCT03209362|147644999|SUPERIORITY||Least Squares Mean Difference|-3.0||||0.6217|TWO_SIDED|95.0|-14.9|9.0|||Longitudinal model|||Week 12||9.0|-14.9|0.6217
74046403|NCT03209362|147644999|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.6901|TWO_SIDED|95.0|-14.8|9.8|||Longitudinal model|||Week 26||9.8|-14.8|0.6901
74046404|NCT00323427|147645013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.0974||0.69|TWO_SIDED|95.0|-0.15|0.23||No multiple testing adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)||0.23|-0.15|0.69
74046405|NCT00323427|147645014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.42|TWO_SIDED|95.0|-0.16|0.38||No adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)||0.38|-0.16|0.42
74046406|NCT00323427|147645015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.15||0.97|TWO_SIDED|95.0|-0.3|0.29||No adjustment|t-test, 2 sided|||H0: mean(Arm 1) = Mean (Arm 2)||0.29|-0.30|0.97
74046407|NCT02493868|147645023|SUPERIORITY||Hazard Ratio (HR)|0.49|||=|0.003|TWO_SIDED|95.0|0.29|0.84|||Weighted Log-rank|||||0.84|0.29|= 0.003
74046408|NCT02407236|147645041|SUPERIORITY||Adjusted treatment difference|10.3|||<|0.001|TWO_SIDED|95.0|5.7|14.9|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1||14.9|5.7|< 0.001
74017894|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.061|=|0.9244|TWO_SIDED|95.0|-0.11|0.13|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 1-- Emraclidine 10 mg versus Placebo||0.13|-0.11|=0.9244
74096501|NCT05958888|147742316|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
74096502|NCT05958888|147742316|SUPERIORITY||Mean Difference (Final Values)|2.39|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
74096503|NCT05958888|147742316|SUPERIORITY||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
74096504|NCT05958888|147742316|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||<.001
74096505|NCT05958888|147742316|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.14||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.01
74096506|NCT05958888|147742316|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.04
74046409|NCT02407236|147645041|SUPERIORITY||Adjusted treatment difference|10.2|||<|0.001|TWO_SIDED|95.0|5.6|14.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2||14.8|5.6|< 0.001
74096507|NCT05958888|147742317|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
74096508|NCT05958888|147742317|SUPERIORITY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
74096509|NCT05958888|147742317|SUPERIORITY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
74096510|NCT05958888|147742317|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.15||0.43|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.43
74017895|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.088|=|0.9348|TWO_SIDED|95.0|-0.17|0.18|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||0.18|-0.17|=0.9348
74046410|NCT02407236|147645042|SUPERIORITY||Adjusted treatment difference|10.3|||<|0.001|TWO_SIDED|97.5|4.8|15.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1||15.8|4.8|< 0.001
74046411|NCT02407236|147645042|SUPERIORITY||Adjusted treatment difference|12.7|||<|0.001|TWO_SIDED|97.5|7.0|18.4|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2||18.4|7.0|< 0.001
74046412|NCT02407236|147645043|SUPERIORITY||Adjusted treatment difference|14.5||||0.002|TWO_SIDED|95.0|5.5|23.6|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1||23.6|5.5|0.002
74046413|NCT02407236|147645043|SUPERIORITY||Adjusted treatment difference|19.7|||<|0.001|TWO_SIDED|95.0|10.3|29.0|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2||29.0|10.3|< 0.001
74096511|NCT05958888|147742317|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.15||0.81|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.81
74096512|NCT05958888|147742317|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.81|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.81
74096513|NCT01781481|147742326|SUPERIORITY_OR_OTHER||Inter-rater reliability|0.87|||||TWO_SIDED||||||||Inter rater reliability for a subset of 40 patients whose Pediatric INTERMED was scored by two trained raters. The median inter-rater reliability coefficient was .87.|||||
74096514|NCT01781481|147742326|SUPERIORITY_OR_OTHER||Cronbach's Alpha|0.91|||||TWO_SIDED||||||||Overall internal consistency of the overall Pediatric INTERMED scale (34 items).|||||
74096515|NCT01781481|147742327|SUPERIORITY_OR_OTHER||||||<|0.05||||||Correlation between the biological and psychological domain scores on the Pediatric INTERMED. The threshold for significance is p\< .05.|Pearson Correlation Coefficients|||||||<0.05
74017896|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.089|=|0.716|TWO_SIDED|95.0|-0.21|0.14|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 2-- Emraclidine 10 mg versus Placebo||0.14|-0.21|=0.7160
74017897|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1|=|0.6883|TWO_SIDED|95.0|-0.24|0.16|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.16|-0.24|=0.6883
74017898|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.1|=|0.5973|TWO_SIDED|95.0|-0.14|0.25|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.25|-0.14|=0.5973
74017899|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.11|=|0.1392|TWO_SIDED|95.0|-0.38|0.05|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||0.05|-0.38|=0.1392
74017900|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.111|=|0.9421|TWO_SIDED|95.0|-0.21|0.23|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 4-- Emraclidine 10 mg versus Placebo||0.23|-0.21|=0.9421
74017901|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.116|=|0.5431|TWO_SIDED|95.0|-0.3|0.16|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 5-- Emraclidine 30 mg versus Placebo||0.16|-0.30|=0.5431
74017902|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.117|=|0.816|TWO_SIDED|95.0|-0.2|0.26|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 5-- Emraclidine 10 mg versus Placebo||0.26|-0.20|=0.8160
74017903|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124|=|0.2534|TWO_SIDED|95.0|-0.39|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.10|-0.39|=0.2534
74096516|NCT01781481|147742327|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Social domain scores on the Pediatric INTERMED.||||<0.01
74096517|NCT01781481|147742327|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Family/Caregiver Pediatric INTERMED domain scores.||||<0.01
74096518|NCT01781481|147742327|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Biological and Health Service Pediatric INTERMED domain scores.||||<0.01
74017904|NCT05227690|147587268|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.125|=|0.6774|TWO_SIDED|95.0|-0.3|0.19|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.19|-0.30|=0.6774
74017905|NCT05227690|147587269|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and Baseline value as a covariate.|Odds Ratio|1.9|||=|0.0904|TWO_SIDED|95.0|0.9|3.99|||Regression, Logistic|||Emraclidine 30 mg versus Placebo||3.99|0.90|=0.0904
74017906|NCT05227690|147587269|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and Baseline value as a covariate.|Odds Ratio|1.96|||=|0.0756|TWO_SIDED|95.0|0.93|4.13|||Regression, Logistic|||Emraclidine 10 mg versus Placebo||4.13|0.93|=0.0756
74017907|NCT05227690|147587276|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.05|=|0.2418|TWO_SIDED|95.0|0.0|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.2|0.0|=0.2418
74017908|NCT05227690|147587276|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.572|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.5720
74017909|NCT05227690|147587276|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06|=|0.7459|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|=0.7459
74017910|NCT05227690|147587276|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06|=|0.6729|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.6729
74017911|NCT05227690|147587277|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.06|=|0.3783|TWO_SIDED|95.0|-0.1|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.2|-0.1|=0.3783
74017912|NCT05227690|147587277|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06|=|0.2242|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.0|-0.2|=0.2242
74017913|NCT05227690|147587277|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.8626|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|=0.8626
74017914|NCT05227690|147587277|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.6106|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.6106
74017915|NCT05227690|147587278|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.4219|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.1|0.0|=0.4219
74017916|NCT05227690|147587278|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.3933|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.1|0.0|=0.3933
74017917|NCT05227690|147587278|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.7366|TWO_SIDED|95.0|0.0|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.0|0.0|=0.7366
74046414|NCT02407236|147645044|SUPERIORITY||Adjusted treatment difference|15.1||||0.002|TWO_SIDED|95.0|6.0|24.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1||24.2|6.0|0.002
74096519|NCT01781481|147742327|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Psychology and Social Pediatric INTERMED domain scores.||||<0.01
74096520|NCT01781481|147742327|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||||||<0.01
74017918|NCT05227690|147587278|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.4639|TWO_SIDED|95.0|-0.1|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.0|-0.1|=0.4639
74017919|NCT03881007|147587279|SUPERIORITY||Incidence rate ratio|1.17||||0.359|TWO_SIDED|95.0|0.84|1.64|||Mixed Models Analysis|||||1.64|0.84|0.359
74017920|NCT03881007|147587280|SUPERIORITY||Incidence rate ratio|5.78||||0.024|TWO_SIDED|95.0|1.52|136.56|||Mixed Models Analysis|||||136.56|1.52|0.024
74017921|NCT03881007|147587281|SUPERIORITY||Incidence rate ratio|1.09||||0.774|TWO_SIDED|95.0|0.61|1.95|||Mixed Models Analysis|||||1.95|0.61|0.774
74096521|NCT01781481|147742327|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological and Health Service Pediatric INTERMED domain scores.||||<0.01
74017922|NCT03881007|147587282|SUPERIORITY||incidence rate ratio|0.59||||0.323|TWO_SIDED|95.0|0.2|1.63|||Mixed Models Analysis|||||1.63|0.2|0.323
74017923|NCT03881007|147587284|SUPERIORITY||Incidence rate ratio|1.21||||0.279|TWO_SIDED|95.0|0.86|1.72|||Mixed Models Analysis|||||1.72|0.86|0.279
74017924|NCT02634580|147587290|SUPERIORITY||LS Mean Treatment Difference|-39.35|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-47.23|-31.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-31.48|-47.23|<0.0001
74017925|NCT02634580|147587291|SUPERIORITY||LS Mean Treatment Difference|-40.14|STANDARD_ERROR_OF_MEAN|4.26|<|0.0001|TWO_SIDED|95.0|-48.68|-31.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-31.60|-48.68|< 0.0001
74017926|NCT02634580|147587292|SUPERIORITY||LS Mean Treatment Difference|-77.6|STANDARD_ERROR_OF_MEAN|8.1|<|0.0001|TWO_SIDED|95.0|-93.9|-61.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-61.3|-93.9|<0.0001
74017927|NCT02634580|147587293|SUPERIORITY||LS Mean Treatment Difference|-79.4|STANDARD_ERROR_OF_MEAN|8.7|<|0.0001|TWO_SIDED|95.0|-96.7|-62.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-62.0|-96.7|<0.0001
74017928|NCT02634580|147587294|SUPERIORITY||Treatment Difference|56.41|||<|0.0001|TWO_SIDED|95.0|34.1|70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe|||70.70|34.10|<0.0001
74017929|NCT02634580|147587295|SUPERIORITY||Treatment Difference|52.63|||<|0.0001|TWO_SIDED|95.0|30.36|67.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe|||67.52|30.36|< 0.0001
74017930|NCT02634580|147587296|SUPERIORITY||LS Mean Treatment Difference|-25.44|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-30.8|-20.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.08|-30.80|<0.0001
74017931|NCT02634580|147587297|SUPERIORITY||LS Mean Treatment Difference|-25.83|STANDARD_ERROR_OF_MEAN|2.89|<|0.0001|TWO_SIDED|95.0|-31.63|-20.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.04|-31.63|<0.0001
74096522|NCT01781481|147742327|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Social and Family/Caregiver Pediatric INTERMED domain scores.||||<0.01
73880634|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0224|TWO_SIDED|95.0|1.19|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.53|1.19|0.0224
73880635|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7891|TWO_SIDED|95.0|0.39|3.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.44|0.39|0.7891
73880636|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|2.48||||0.0851|TWO_SIDED|95.0|0.88|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.99|0.88|0.0851
73880637|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2885|TWO_SIDED|95.0|0.63|4.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.83|0.63|0.2885
73880638|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|0.78||||0.8611|TWO_SIDED|95.0|0.05|13.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||13.30|0.05|0.8611
73880639|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.48||||0.7549|TWO_SIDED|95.0|0.13|17.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||17.42|0.13|0.7549
74017932|NCT02634580|147587298|SUPERIORITY||LS Mean Treatment Difference|-33.53|STANDARD_ERROR_OF_MEAN|3.42|<|0.0001|TWO_SIDED|95.0|-40.38|-26.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-26.68|-40.38|< 0.0001
73880640|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|2.07||||0.5658|TWO_SIDED|95.0|0.17|24.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||24.66|0.17|0.5658
74017933|NCT02634580|147587299|SUPERIORITY||LS Mean Treatment Difference|-33.44|STANDARD_ERROR_OF_MEAN|3.75|<|0.0001|TWO_SIDED|95.0|-40.94|-25.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-25.94|-40.94|<0.0001
74017934|NCT02634580|147587300|SUPERIORITY||LS Mean Treatment Difference|-35.67|STANDARD_ERROR_OF_MEAN|3.31|<|0.0001|TWO_SIDED|95.0|-42.3|-29.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.04|-42.30|< 0.0001
74017935|NCT02634580|147587301|SUPERIORITY||LS Mean Treatment Difference|-36.6|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|-43.98|-29.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.22|-43.98|<0.0001
74096523|NCT01781481|147742327|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Social and Health Service Pediatric INTERMED domain scores.||||<0.01
73880641|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.83||||0.6319|TWO_SIDED|95.0|0.15|21.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||21.86|0.15|0.6319
73880642|NCT03192176|147297624|SUPERIORITY||Odds Ratio (OR)|1.09||||0.9526|TWO_SIDED|95.0|0.06|18.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||18.96|0.06|0.9526
73880643|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2251|TWO_SIDED|95.0|0.71|4.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||4.26|0.71|0.2251
74017936|NCT02634580|147587302|SUPERIORITY||LS Mean Treatment Difference|-28.61|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|-35.26|-21.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-21.97|-35.26|< 0.0001
74096524|NCT01781481|147742327|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Family/Caregiver and Health Service Pediatric INTERMED domain scores.||||<0.01
74096525|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity at Diagnosis||||>0.05
73888076|NCT01746901|147309534|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.1728|TWO_SIDED|95.0|-3.9|0.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-3.9|0.1728
74017937|NCT02634580|147587303|SUPERIORITY||LS Mean Treatment Difference|-27.05|STANDARD_ERROR_OF_MEAN|3.47|<|0.0001|TWO_SIDED|95.0|-34.0|-20.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.09|-34.00|< 0.0001
74017938|NCT02634580|147587304|SUPERIORITY||LS Mean Treatment Difference|-37.07|STANDARD_ERROR_OF_MEAN|3.28|<|0.0001|TWO_SIDED|95.0|-43.65|-30.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-30.50|-43.65|<0.0001
74017939|NCT02634580|147587305|SUPERIORITY||LS Mean Treatment Difference|-36.29|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-43.39|-29.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.20|-43.39|<0.0001
74017940|NCT02634580|147587306|SUPERIORITY||LS Mean Treatment Difference|-31.13|STANDARD_ERROR_OF_MEAN|5.34|<|0.0001|TWO_SIDED|95.0|-41.83|-20.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.43|-41.83|<0.0001
74017941|NCT02634580|147587307|SUPERIORITY||LS Mean Treatment Difference|-31.21|STANDARD_ERROR_OF_MEAN|6.17|<|0.0001|TWO_SIDED|95.0|-43.57|-18.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-18.84|-43.57|<0.0001
74017942|NCT02634580|147587308|SUPERIORITY||LS Mean Treatment Difference|3.49|STANDARD_ERROR_OF_MEAN|7.31||0.63|TWO_SIDED|95.0|-11.15|18.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||18.13|-11.15|0.63
74017943|NCT02634580|147587309|SUPERIORITY||LS Mean Treatment Difference|11.79|STANDARD_ERROR_OF_MEAN|9.52||0.22|TWO_SIDED|95.0|-7.29|30.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||30.87|-7.29|0.22
74017944|NCT02634580|147587310|SUPERIORITY||LS Mean Treatment Difference|7.96|STANDARD_ERROR_OF_MEAN|3.08||0.012|TWO_SIDED|95.0|1.78|14.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||14.14|1.78|0.012
74017945|NCT02634580|147587311|SUPERIORITY||LS Mean Treatment Difference|5.59|STANDARD_ERROR_OF_MEAN|3.2||0.086|TWO_SIDED|95.0|-0.82|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||12.00|-0.82|0.086
74017946|NCT02634580|147587312|SUPERIORITY||LS Mean Treatment Difference|-0.67|STANDARD_ERROR_OF_MEAN|7.26||0.93|TWO_SIDED|95.0|-15.22|13.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||13.87|-15.22|0.93
73888077|NCT01746901|147309534|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.2616|TWO_SIDED|95.0|-1.0|3.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.6|-1.0|0.2616
74046415|NCT02407236|147645044|SUPERIORITY||Adjusted treatment difference|17.9|||<|0.001|TWO_SIDED|95.0|8.6|27.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2||27.2|8.6|< 0.001
74046416|NCT00616772|147645121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.22|TWO_SIDED|95.0|-0.016|0.004|||Repeated measures linear mixed model|Fixed effects for baseline cIMT, baseline atorvastatin dose, central imaging site, treatment group, time; interaction between treatment group and time||||0.004|-0.016|0.220
74046417|NCT00616772|147645122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.813|TWO_SIDED|95.0|-0.014|0.011|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline cIMT as covariate.||||0.011|-0.014|0.813
74046418|NCT00616772|147645123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.249|TWO_SIDED|95.0|-0.018|0.005|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.005|-0.018|0.249
74046419|NCT00616772|147645124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005||||0.487|TWO_SIDED|95.0|-0.02|0.01|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.010|-0.020|0.487
74046420|NCT00616772|147645125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.112|TWO_SIDED|95.0|-0.004|0.035|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.035|-0.004|0.112
74046421|NCT01462045|147645141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|5.7|<|0.01|TWO_SIDED|95.0|-25.6|-1.6|||t-test, 2 sided|||||-1.6|-25.6|<0.01
74046422|NCT01462045|147645142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|2.4|<|0.01|TWO_SIDED|95.0|0.83|10.8|||t-test, 2 sided|||||10.8|0.83|<0.01
73880644|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0084|TWO_SIDED|95.0|1.39|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||9.20|1.39|0.0084
73880645|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|5.71||||0.0007|TWO_SIDED|95.0|2.09|15.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||15.62|2.09|0.0007
73880646|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|5.11||||0.0015|TWO_SIDED|95.0|1.87|14.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.00|1.87|0.0015
73880647|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6976|TWO_SIDED|95.0|0.48|2.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||2.95|0.48|0.6976
73880648|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|4.57||||0.0021|TWO_SIDED|95.0|1.73|12.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.05|1.73|0.0021
74017947|NCT02634580|147587313|SUPERIORITY||LS Mean Treatment Difference|7.64|STANDARD_ERROR_OF_MEAN|9.88||0.44|TWO_SIDED|95.0|-12.15|27.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||27.43|-12.15|0.44
74017948|NCT00584233|147587314|NON_INFERIORITY|The statistical test will be to assess non-inferiority. The non-inferiority margin is -0.04 in AUC. Key parameters are the number of participating patients, the number of radiologists reading the images in the study. Power analysis was conducted using the standard simulation from the ROC literature (Roe and Metz, Academic Radiology 1997). With a total of 100 participating patients and 4 participating readers, we achieve a power \>80% with a non-inferiority margin of -0.04.|Obuchowski Rockette methodology|0.05||||0.05|TWO_SIDED|95.0|0.025|0.975|||Obuchowski Rockette|||The analysis is intended to evaluate non-inferiority in observer performance between CE-bCT and CE-bMRI as assessed by the area under the ROC curve (AUC). The null hypothesis is that the observed difference in average AUC for CE-bCT and CE-bMRI will be outside of a non-inferiority margin of -0.04. See below for details of the power analyses.||.975|.025|0.05
74017949|NCT01340209|147587357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.048||0.7971|TWO_SIDED|95.0|-0.082|0.106|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||0.106|-0.082|0.7971
74017950|NCT01340209|147587357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.048||0.0203|TWO_SIDED|95.0|0.018|0.207|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||0.207|0.018|0.0203
74017951|NCT01340209|147587358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037|STANDARD_ERROR_OF_MEAN|0.053||0.4944|TWO_SIDED|95.0|-0.141|0.068|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||0.068|-0.141|0.4944
74046423|NCT02579863|147645143|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.33475|TWO_SIDED|95.0|0.56|1.45|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III).|||1.45|0.56|0.33475
74046424|NCT02579863|147645144|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.83416|TWO_SIDED|95.0|0.81|1.84|||Stratified log-rank test||"Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III)."|||1.84|0.81|0.83416
74046425|NCT02579863|147645145|SUPERIORITY||Difference in % vs SOC|5.8||||0.13102|TWO_SIDED|95.0|-4.3|15.8|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|||Based on Miettinen \& Nurminen method stratified by 'Age' (\<75 years vs \>= 75 years) and 'ISS stage' (I or II vs. III); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.|15.8|-4.3|0.13102
74046426|NCT02658149|147645152|OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
74046427|NCT02658149|147645153|OTHER|||||||0.204|||||||Wilcoxon (Mann-Whitney)|||||||0.204
73880649|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0171|TWO_SIDED|95.0|1.22|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||7.68|1.22|0.0171
73880650|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2224|TWO_SIDED|95.0|0.69|5.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.04|0.69|0.2224
73880651|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2716|TWO_SIDED|95.0|0.65|4.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.69|0.65|0.2716
74046428|NCT02658149|147645154|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
74046429|NCT02658149|147645155|OTHER|||||||0.741|||||||t-test, 2 sided|||||||0.741
73880652|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|4.49||||0.0112|TWO_SIDED|95.0|1.41|14.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.32|1.41|0.0112
74017952|NCT01340209|147587358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.054||0.127|TWO_SIDED|95.0|-0.023|0.188|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||0.188|-0.023|0.1270
73880653|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.08||||0.0461|TWO_SIDED|95.0|1.02|9.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.31|1.02|0.0461
73880654|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3463|TWO_SIDED|95.0|0.59|4.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.47|0.59|0.3463
74017953|NCT01340209|147587359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.498|STANDARD_ERROR_OF_MEAN|12.282||0.9677|TWO_SIDED|95.0|-23.634|24.63|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||24.630|-23.634|0.9677
73880655|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0419|TWO_SIDED|95.0|1.04|8.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.92|1.04|0.0419
74017954|NCT01340209|147587359|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|34.176|STANDARD_ERROR_OF_MEAN|12.346||0.0058|TWO_SIDED|95.0|9.919|58.432|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium Respimat 5 μg minus placebo||58.432|9.919|0.0058
74017955|NCT01340209|147587360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.646|STANDARD_ERROR_OF_MEAN|9.182||0.3468|TWO_SIDED|95.0|-9.388|26.68|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||26.680|-9.388|0.3468
74017956|NCT01340209|147587360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.216|STANDARD_ERROR_OF_MEAN|9.238||0.5013||95.0|-11.927|24.359|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||24.359|-11.927|0.5013
74017957|NCT01340209|147587361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.458|STANDARD_ERROR_OF_MEAN|9.196||0.2132|TWO_SIDED|95.0|-6.601|29.517|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||29.517|-6.601|0.2132
74017958|NCT01340209|147587361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.398|STANDARD_ERROR_OF_MEAN|9.245||0.0766|TWO_SIDED|95.0|-1.759|34.555|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||34.555|-1.759|0.0766
74017959|NCT01340209|147587362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.601|STANDARD_ERROR_OF_MEAN|1.038||0.5629|TWO_SIDED|95.0|-2.637|1.436|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||1.436|-2.637|0.5629
74017960|NCT01340209|147587362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.564|STANDARD_ERROR_OF_MEAN|1.038||0.5871|TWO_SIDED|95.0|-1.473|2.601|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||2.601|-1.473|0.5871
74017961|NCT00523991|147587480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.27||"There was only one primary endpoint and the p-value was not adjusted for multiple comparisons.~Mean Difference (Final Values) means difference in LS-Means"|ANCOVA|The analysis of covariance model included treatment, site, and trough forced expiratory volume in 1 second at baseline in the model.||||0.27|0.18|<0.001
74017962|NCT00523991|147587484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and trough forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.18|0.09|<0.001
74017963|NCT00523991|147587488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.19|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and peak forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.29|0.19|<0.001
74017964|NCT00523991|147587504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"Terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.18|0.09|<0.001
74017965|NCT00523991|147587505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.001||95.0|0.16|0.25||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.25|0.16|<0.001
74046430|NCT02658149|147645156|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
74046431|NCT03053401|147645160|OTHER|Test of difference was conducted.||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
74046432|NCT03053401|147645161|OTHER|||||||0.762||||||Alpha = 0.025 for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.762
73880656|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.68||||0.2977|TWO_SIDED|95.0|0.63|4.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.46|0.63|0.2977
74046433|NCT03053401|147645161|OTHER|||||||0.41||||||Alpha = 0.025 for multiple comparisons.|Wilcoxon Rank Sum Test with Exact Option|||||||0.410
73880657|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.87||||0.23|TWO_SIDED|95.0|0.67|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.21|0.67|0.2300
73880658|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0655|TWO_SIDED|95.0|0.94|8.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.58|0.94|0.0655
74046434|NCT03053401|147645162|OTHER|Test of Difference conducted.||||||0.454|||||||t-test, 2 sided|||||||0.454
74046435|NCT02352090|147645194|OTHER|||||||0.27|||||||ANOVA|||||||0.27
74046436|NCT00981292|147645224|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||A Bonferroni adjustment was made for multiplicity.|ANOVA|||This data was analysed by two-way repeated measures ANOVA (task \[epoch\] x treatment). In the case of those analyses that showed a significant main effect of treatment or a task/epoch x treatment interaction, planned comparisons of data from each task or epoch were then made between placebo and each of the EGCG treatment groups using t tests calculated with the Mean Squares Error from the ANOVA.||||<0.05
74046437|NCT00981292|147645225|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||Task performance data were analysed by within subjects ANCOVA (treatment) with pre-treatment performance included as a co-variate for each individual task/measure.||||>0.05
74046438|NCT00981292|147645226|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Mood data was analysed via student t-test.||||>0.05
74046439|NCT01849562|147645263|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|50.0|||||TWO_SIDED|95.0|1.8|82.7||||||Differences in proportions between Group 1 (sovaprevir 200 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.||82.7|1.8|
74046440|NCT01849562|147645263|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|70.0|||||TWO_SIDED|95.0|24.2|93.6||||||Differences in proportions between Group 2 (sovaprevir 400 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.||93.6|24.2|
74046441|NCT02182999|147645275|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.596|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A sample size of 17 patients in each group was previously calculated on the basis of a significance level of .05, a power of 80%, an anticipated pooled standard Deviation (SD) of 1.0 of the mean verbal NRS pain level, and a minimal clinically important difference in the mean verbal NRS pain level of 1.0 points between the groups. Anticipating a loss to follow-up, we planned to recruit a total of 50 patients (25 patients each group).||||0.596
74046442|NCT02182999|147645276|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.353
74046443|NCT01791465|147645310|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
74046444|NCT01791465|147645311|SUPERIORITY_OR_OTHER|||||||0.34||||||Unadjusted - this was a Wilcoxon signed rank p-value (Baseline vs. week 16) comparison|Wilcoxon (Mann-Whitney)|no adjustments||The null hypothesis was that there would be no difference between baseline and 16 week IL-6||||0.34
74046445|NCT01791465|147645312|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
74046446|NCT01791465|147645313|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
74046447|NCT01791465|147645314|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
74046448|NCT01791465|147645315|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
74046449|NCT01791465|147645316|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
74046450|NCT01791465|147645317|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
74046451|NCT01791465|147645318|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
74096526|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity (at time of Study Participation).||||<0.01
74017966|NCT00523991|147587506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium vesus placebo||0.28|0.18|<0.001
74017967|NCT00523991|147587507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.2|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.29|0.20|<0.001
74096527|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (child rating).||||<0.01
74096528|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (parent rating).||||<0.01
74017968|NCT00523991|147587508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.001||95.0|0.2|0.3||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.30|0.20|<0.001
74096529|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Impact Quality of Life: General Well Being scale.||||<0.01
74096530|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Surgeries.||||>0.05
74096531|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Courses of Prednisone.||||>0.05
74096532|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of Immunomodulators.||||>0.05
74096533|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of ant-TNFa medications.||||>0.05
74096534|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at Diagnosis.||||>0.05
74096535|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).||||>0.05
74096536|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Child Report)||||>0.05
74096537|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Parent)||||<0.01
74096538|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Impact Quality of Life: General Well-Being.||||>0.05
74096539|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Surgeries.||||>0.05
74096540|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Courses of Prednisone.||||>0.05
74096541|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\< 0.05.|Spearman Correlation Coefficent|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Use of Immunomodulators (azathioprine or methotrexate)||||<0.05
74096542|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and use of anti-TNFa medications.||||>0.05
74096543|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Disease Severity at Diagnosis."||||>0.05
74096544|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and IBD Disease Severity at time of study participation."||||<0.01
74096545|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (child rating)."||||<0.01
74017969|NCT00523991|147587512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|||<|0.001||95.0|0.24|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity area under the curve at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.38|0.24|<0.001
74017970|NCT00523991|147587516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and trough forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.28|0.14|<0.001
74017971|NCT00523991|147587520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.24|0.42||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.42|0.24|<0.001
74017972|NCT00523991|147587536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.28|0.14|<0.001
74017973|NCT00523991|147587537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||<|0.001||95.0|0.21|0.36||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.36|0.21|<0.001
74017974|NCT00523991|147587538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.001||95.0|0.23|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.38|0.23|<0.001
74017975|NCT00523991|147587539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.25|0.4||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.40|0.25|<0.001
74017976|NCT00523991|147587540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||<|0.001||95.0|0.26|0.45||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.45|0.26|<0.001
74017977|NCT00523991|147587547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.927||95.0|-0.38|0.41||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and albuterol use at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.41|-0.38|0.927
74017978|NCT00523991|147587548|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.174
74017979|NCT00523991|147587549|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.186
73880659|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0245|TWO_SIDED|95.0|1.19|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.11|1.19|0.0245
73880660|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|5.62||||0.0129|TWO_SIDED|95.0|1.44|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.93|1.44|0.0129
74017980|NCT00523991|147587550|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.045
74017981|NCT00523991|147587551|SUPERIORITY_OR_OTHER|||||||0.223||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.223
74017982|NCT00523991|147587552|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.010
74017983|NCT00523991|147587553|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.086
74017984|NCT00523991|147587555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.729||95.0|-2.97|4.24||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||4.24|-2.97|0.729
74017985|NCT00523991|147587556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.149||95.0|-5.9|0.9||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||0.90|-5.90|0.149
74046452|NCT01791465|147645319|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
74046453|NCT01791465|147645320|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
74017986|NCT00523991|147587557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.763||95.0|-4.0|2.93||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||2.93|-4.00|0.763
74017987|NCT00523991|147587558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.313||95.0|-5.45|1.75||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||1.75|-5.45|0.313
74046454|NCT01791465|147645321|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
74046455|NCT01791465|147645322|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
74046456|NCT01791465|147645323|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
74046457|NCT01791465|147645324|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
74046458|NCT01791465|147645325|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
74046459|NCT01791465|147645326|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
74046460|NCT01791465|147645327|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
74096546|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (Parent Rating)"||||<0.01
74096547|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Impact Quality of Life: General Well-Being Scale"||||<0.01
74096548|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Surgeries"||||>0.05
73880661|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1259|TWO_SIDED|95.0|0.79|7.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.15|0.79|0.1259
73880662|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1015|TWO_SIDED|95.0|0.84|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.82|0.84|0.1015
73880663|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0167|TWO_SIDED|95.0|1.31|15.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.33|1.31|0.0167
73880664|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5232|TWO_SIDED|95.0|0.5|3.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.95|0.50|0.5232
73880665|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.0||||0.2055|TWO_SIDED|95.0|0.68|5.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.82|0.68|0.2055
73880666|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0658|TWO_SIDED|95.0|0.93|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.64|0.93|0.0658
73880667|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|7.34||||0.0136|TWO_SIDED|95.0|1.51|35.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||35.75|1.51|0.0136
73880668|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3238|TWO_SIDED|95.0|0.59|5.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.00|0.59|0.3238
73880669|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0118|TWO_SIDED|95.0|1.48|23.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||23.21|1.48|0.0118
74046461|NCT01791465|147645328|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
74046462|NCT01791465|147645329|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
74046463|NCT01791465|147645330|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
74046464|NCT02972593|147645335|OTHER|Data collapsed to participant level, creating an ever/never response for each participant for each infection outcome type. Analyses performed at the participant level to determine if proportion of outcome types were similar between transfusion groups using Fisher's Exact tests, due to small expected cell counts, using SAS v9.4 (SAS Institute, Cary, NC). Power analyses performed based on these proportions using bootstrapping methods in SAS and confirmed with nQuery v8.7.1.0.||||||0.0122|||||||Fisher Exact|||||||.0122
74046465|NCT02972593|147645336|OTHER|||||||0.7742|||||||Fisher Exact|||||||.7742
74046466|NCT02972593|147645337|OTHER|||||||0.1443|||||||t-test, 1 sided|||||||.1443
74096549|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Courses of Prednisone."||||>0.05
74017988|NCT00523991|147587559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.682||95.0|-4.6|3.01||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||3.01|-4.60|0.682
74017989|NCT00523991|147587560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76||||0.043||95.0|-7.39|-0.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||-0.13|-7.39|0.043
74096550|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of Immunomodulators."||||>0.05
74017990|NCT00523991|147587562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.823||95.0|-6.01|4.79||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||4.79|-6.01|0.823
74017991|NCT00523991|147587563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.767||95.0|-7.86|5.81||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.81|-7.86|0.767
74017992|NCT00523991|147587564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.754||95.0|-4.12|5.67||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.67|-4.12|0.754
74017993|NCT00523991|147587565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.995||95.0|-6.31|6.27||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.27|-6.31|0.995
74017994|NCT00523991|147587566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.72||95.0|-7.77|5.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.39|-7.77|0.720
74017995|NCT00523991|147587567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88||||0.064||95.0|-12.1|0.35||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||0.35|-12.10|0.064
74017996|NCT00523991|147587569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.718||95.0|-7.21|4.98||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||4.98|-7.21|0.718
74017997|NCT00523991|147587570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.912||95.0|-7.9|7.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||7.06|-7.90|0.912
74017998|NCT00523991|147587571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.79||||0.162||95.0|-1.55|9.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||9.13|-1.55|0.162
74017999|NCT00523991|147587572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59||||0.471||95.0|-4.51|9.69||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||9.69|-4.51|0.471
74018000|NCT00523991|147587573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.961||95.0|-6.52|6.84||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.84|-6.52|0.961
74018001|NCT00523991|147587574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.158||95.0|-11.73|1.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||1.94|-11.73|0.158
74096551|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of anti-TNFa Medications."||||>0.05
74096552|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05. The P-Value indicated above was found for all the correlations which were examined.|Spearman Correlation Coefficient|||"Correlations between Pediatric INTERMED Diagnostic Dilemma Item (Historical Biological) and Functional Disability Index (Parent) and each of the following variables: Disease Severity at Diagnosis, Disease Severity at Interview, Functional Disability Index - Child, Functional Disability Index- Parent, Impact Quality of Life: General Well Being, Number of Surgeries, Number of Courses of Prednisone, Use of Immunomodulators, Use of Anti-TNFa Medications."||||>0.05
74096553|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at Diagnosis."||||>0.05
74096554|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at time of study participation."||||<0.05
74096555|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (Child Rating)"||||<0.05
74096556|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (parent rating)."||||>0.05
74096557|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Impact Quality of LIfe: General Well-Being Scale"||||<0.01
74096558|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Surgeries."||||>0.05
73880670|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|5.29||||0.0163|TWO_SIDED|95.0|1.36|20.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||20.62|1.36|0.0163
74018002|NCT00523991|147587576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.74||||0.469||95.0|-3.01|6.49||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.49|-3.01|0.469
74096559|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Courses of Prednisone."||||>0.05
74096560|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of Immunomodulators. ."||||>0.05
74096561|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of anti-TNFa Medications"||||>0.05
74096562|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at Diagnosis."||||>0.05
74096563|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview)."||||>0.05
74096564|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Child Rating)."||||>0.05
74096565|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Parent Rating)"||||>0.05
74096566|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Impact Quality of Life: General Well-Being"||||>0.05
74096567|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Surgeries."||||>0.05
74096568|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Courses of Prednisone since diagnosis."||||<0.05
74096569|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significiance is p\<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of Immunomodulators (azathioprine or methotrexate)."||||<0.01
74096570|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The Threshold for significance is p\<0.05)|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of ant-TNFa Medications (infliximab or adalimumab)."||||<0.01
74096571|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at diagnosis."||||>0.05
74096572|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at study participation."||||<0.05
74096573|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (Child Rating)."||||<0.01
74096574|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (parent rating)."||||<0.01
74096575|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Impact Quality of Life: General Well Being Scale."||||<0.05
74096576|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Surgeries."||||>0.05
74096577|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Courses of Prednisone."||||>0.05
74096578|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of Immunomodulators (azathioprine or methotrexate)."||||<0.05
74096579|NCT01781481|147742341|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of anti-TNFa Medications."||||>0.05
74096580|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
73880671|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6363|TWO_SIDED|95.0|0.42|4.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.18|0.42|0.6363
74018003|NCT00523991|147587577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.79||||0.079||95.0|-0.68|12.26||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||12.26|-0.68|0.079
74096581|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
74096582|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Children's Depression Inventory: Total Score||||<0.01
74096583|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Multidimensional Anxiety Scale for Children: Total Score.||||<0.05
74096584|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale||||<0.01
74096585|NCT01781481|147742342|SUPERIORITY_OR_OTHER|||||||0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Social Competence Scale (Child Behaviour Checklist).||||0.01
73880672|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.68||||0.0722|TWO_SIDED|95.0|0.89|15.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.25|0.89|0.0722
74096586|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.05
74096587|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
74096588|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Social Scale||||<0.01
74096589|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.05
74096590|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).||||<0.01
74096591|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
74096592|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
74096593|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
74046467|NCT02069704|147645339|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio BEVZ92 to Avastin|99.4|||||TWO_SIDED|90.0|90.5|109.0|||||For the ratio: BEVZ92 represents the numerator and reference bevacizumab the denominator|Based on previously published PK data for reference bevacizumab in metastatic colorectal cancer, we assumed a conservative inter-participant coefficient of variation for AUC of around 35%. A sample size of 51 patients in each treatment arm could show bioequivalence with a nominal power of 90% and an α of 0·05, if the 90% CIs for the ratio of BEVZ92 to reference bevacizumab of the geometric means for AUC0-336h and AUCss were within the acceptance interval of 80%-125%.||109.0|90.5|
74046468|NCT02069704|147645340|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio BEVZ92 to Avastin|100.0|||||TWO_SIDED|90.0|90.2|112.0||||||||112.0|90.2|
74046469|NCT01236768|147645354|EQUIVALENCE|Comparative analysis of AG200-15 and Levora for breakthrough bleeding and/or spotting.||||||0.089|||||||Chi-squared|||Comparative evaluation of AG200-15 and Levora||||0.089
74046470|NCT00638690|147645358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.646|||<|0.0001|TWO_SIDED|95.0|0.543|0.768||Nominal P-value is 0.0142 at interim analysis based on group sequential design.|Log Rank|This was a stratified analysis.||||0.768|0.543|<0.0001
74046471|NCT00638690|147645359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.462|0.728||Nominal P-value = 0.05.|Log Rank|This was a stratified analysis.||||0.728|0.462|<0.0001
74046472|NCT00638690|147645360|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.266|||<|0.001|TWO_SIDED|95.0|3.459|8.018||Nominal P-value = 0.05.|Chi-squared|||||8.018|3.459|<0.001
74046473|NCT00638690|147645361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.673|||<|0.0001|TWO_SIDED|95.0|0.585|0.776||The nominal P-value = 0.05.|Log Rank|This was a stratified analysis.||||0.776|0.585|<0.0001
74046474|NCT02809846|147645413|OTHER|Bivariate associations between variables were assessed using statistical methods appropriate for the variable types. Baseline characteristics (demographics, other morbidities, baseline medication use, pain intensity and QOL) were compared between the two treatment groups to assess effectiveness of randomization and identify important covariates for multivariable analyses. Associations between demographic variables and primary and secondary endpoints were examined.|||||<|0.05||||||Sensitivity analyses comparing use of data from all participants with use of participants with complete data only was also performed. Agreement between different measures representing the same variable type was assessed using correlation analyses.|Mixed Models Analysis|Multivariable analysis with mixed effect regression models were used to assess the effect of treatment group on the primary and secondary outcomes.||Initially, a sample size of 20 participants per treatment group (active and sham) was selected to achieve 90% power to find a 20% difference in mean percent change in opioid consumption between the two groups with an estimated standard deviation of 22% and 80% power to detect the same difference with a standard deviation of 19% at a two-sided alpha = 0.05|Similar models were used to assess associations of treatment group with secondary endpoints. Model fit was assessed by Akaike's Information Criteria to determine optimal covariance structure.|||<0.05
74046475|NCT01620593|147645415|SUPERIORITY|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74046476|NCT03054740|147645419|SUPERIORITY||||||||||||||||||Levene's Test of Equality of Error Variances (Design: Intercept + Pain Previous IV + Intervention) F = .001, df1 = 1, df2=28, Sig. = .972|||
74046477|NCT03054740|147645420|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||.390
74046478|NCT02667392|147645426|OTHER|||||||0.77||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.77
74046479|NCT02667392|147645427|OTHER|||||||0.61||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.61
74046480|NCT02667392|147645428|OTHER|||||||0.28||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.28
74046481|NCT02667392|147645429|OTHER|||||||0.002||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.002
74046482|NCT02667392|147645430|OTHER|||||||0.02||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.02
74046483|NCT02667392|147645431|OTHER|||||||0.03||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.03
74096594|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Children's Depression Inventory: Total Score||||<0.01
74096595|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Multidimensional Anxiety Scale for Children: Total Score.||||<0.05
74046484|NCT02667392|147645432|OTHER|||||||0.55||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.55
74046485|NCT02667392|147645433|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.0089|||||||t-test, 2 sided|||||||0.0089
74096596|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Emotional Scale||||<0.01
74046486|NCT02667392|147645434|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.73|||||||t-test, 2 sided|||||||0.73
74046487|NCT02667392|147645435|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.81|||||||t-test, 2 sided|||||||0.81
74046488|NCT02667392|147645436|OTHER|||||||0.02||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.02
74046489|NCT02033850|147645437|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||Δs on ADL (baseline vs 6 months)||||.145
74046490|NCT02033850|147645437|SUPERIORITY|||||||0.618|||||||t-test, 2 sided|||Δs on ADL (6 vs 12 months)||||.618
74046491|NCT02033850|147645437|SUPERIORITY|||||||0.262|||||||t-test, 2 sided|||Δs on ADL (baseline vs 12 months)||||.262
74046492|NCT02033850|147645437|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Δs on IADL (baseline vs 6 months)||||.240
74046493|NCT02033850|147645437|SUPERIORITY|||||||0.134|||||||t-test, 2 sided|||Δs on IADL (6 vs 12 months)||||.134
74018004|NCT00523991|147587578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.051||95.0|-0.02|8.23||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||8.23|-0.02|0.051
74018005|NCT00523991|147587579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43||||0.075||95.0|-0.35|7.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||7.21|-0.35|0.075
74018006|NCT00523991|147587580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.306||95.0|-1.39|4.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and work productivity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||4.38|-1.39|0.306
74018007|NCT00523991|147587581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.363||95.0|-7.39|2.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||2.73|-7.39|0.363
74018008|NCT00523991|147587583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.668||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and logarithm of baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.02|-0.03|0.668
74096597|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Social Competence Scale (Child Behaviour Checklist).||||<0.01
74096598|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.01
74096599|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
74096600|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Social Scale||||<0.01
74018009|NCT00523991|147587584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.78||95.0|-0.02|0.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.03|-0.02|0.780
74018010|NCT00523991|147587585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.61||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.02|-0.03|0.610
74096601|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.01
74018011|NCT00523991|147587586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.554||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.554
74018012|NCT00523991|147587587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.549||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.549
74018013|NCT00523991|147587588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.568||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.568
74046494|NCT02033850|147645437|SUPERIORITY|||||||0.457|||||||t-test, 2 sided|||Δs on IADL (baseline vs 12 months)||||.457
74046495|NCT02033850|147645437|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||Δs on DAD (baseline vs 6 months)||||.612
74046496|NCT02033850|147645437|SUPERIORITY|||||||0.522|||||||t-test, 2 sided|||Δs on DAD (6 vs 12 months)||||.522
74046497|NCT02033850|147645437|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Δs on DAD (baseline vs 12 months)||||.800
74046498|NCT02033850|147645438|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||Δs on AQ (baseline vs 6 months)||||.204
74046499|NCT02033850|147645438|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||Δs on AQ (6 vs 12 months)||||.810
74046500|NCT02033850|147645438|SUPERIORITY|||||||0.193|||||||t-test, 2 sided|||Δs on AQ (baseline vs 12 months)||||.193
74046501|NCT02033850|147645438|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 6 months)||||.698
74096602|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Life Events (family stress measure).||||<0.01
74046502|NCT02033850|147645438|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||Δs on EQ index (6 vs 12 months)||||.283
74096603|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
74096604|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
74096605|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
74018014|NCT00523991|147587590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.358||95.0|-0.18|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.07|-0.18|0.358
74018015|NCT00523991|147587591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.219||95.0|-0.2|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.05|-0.20|0.219
74018016|NCT00523991|147587592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.518||95.0|-0.1|0.19||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.19|-0.10|0.518
74018017|NCT00523991|147587593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.455||95.0|-0.09|0.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.21|-0.09|0.455
74018018|NCT00523991|147587594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.927||95.0|-0.16|0.15||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.15|-0.16|0.927
74018019|NCT00523991|147587595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.933||95.0|-0.17|0.16||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.16|-0.17|0.933
74018020|NCT00523991|147587596|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.996
74018021|NCT00523991|147587597|SUPERIORITY_OR_OTHER|||||||0.196||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.196
74018022|NCT00523991|147587598|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.800
74018023|NCT00523991|147587599|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.215
74018024|NCT00523991|147587600|SUPERIORITY_OR_OTHER|||||||0.205||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.205
74018025|NCT00523991|147587601|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.622
74018026|NCT00523991|147587602|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.446
74018027|NCT00523991|147587604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.819||95.0|-0.05|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.06|-0.05|0.819
74018028|NCT00523991|147587605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.204||95.0|-0.1|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.02|-0.10|0.204
74018029|NCT00523991|147587606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.67||95.0|-0.08|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.05|-0.08|0.670
74018030|NCT00523991|147587607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.63||95.0|-0.09|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.06|-0.09|0.630
74018031|NCT00523991|147587608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.704||95.0|-0.1|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.07|-0.10|0.704
74018032|NCT00523991|147587609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.579||95.0|-0.11|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.06|-0.11|0.579
74046503|NCT02033850|147645438|SUPERIORITY|||||||0.647|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 12 months)||||.647
74046504|NCT02033850|147645438|SUPERIORITY|||||||0.057|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 6 months)||||.057
74096606|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Children's Depression Inventory: Total Score||||<0.01
74096607|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Multidimensional Anxiety Scale for Children: Total Score.||||>0.05
74096608|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale||||<0.01
74096609|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Social Competence Scale (Child Behaviour Checklist).||||<0.01
74096610|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.01
73880673|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.35||||0.2019|TWO_SIDED|95.0|0.63|8.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.73|0.63|0.2019
74046505|NCT02033850|147645438|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||Δs on EQ visual (6 vs 12 months)||||.685
74046506|NCT02033850|147645438|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 12 months)||||.056
74046507|NCT02033850|147645438|SUPERIORITY|||||||0.393|||||||t-test, 2 sided|||Δs on GDS (baseline vs 6 months)||||.393
74046508|NCT02033850|147645438|SUPERIORITY|||||||0.958|||||||t-test, 2 sided|||Δs on GDS (6 vs 12 months)||||.958
74046509|NCT02033850|147645438|SUPERIORITY|||||||0.448|||||||t-test, 2 sided|||Δs on GDS (baseline vs 12 months)||||.448
74046510|NCT02033850|147645438|SUPERIORITY|||||||0.567|||||||t-test, 2 sided|||Δs on MCS (baseline vs 6 months)||||.567
74046511|NCT02033850|147645438|SUPERIORITY|||||||0.274|||||||t-test, 2 sided|||Δs on MCS (6 vs 12 months)||||.274
74046512|NCT02033850|147645438|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||Δs on MCS (baseline vs 12 months)||||.668
74046513|NCT02033850|147645438|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||Δs on PCS (baseline vs 6 months)||||.709
74046514|NCT02033850|147645438|SUPERIORITY|||||||0.567|||||||t-test, 2 sided|||Δs on PCS (6 vs 12 months)||||.567
74096611|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
74096612|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Impact Quality of Life: Social Scale||||<0.01
74096613|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.01
74096614|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).||||<0.01
74096615|NCT01781481|147742342|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
74096616|NCT01781481|147742343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.33|||||TWO_SIDED|95.0|2.02|34.47||||||||34.47|2.02|
74096617|NCT01781481|147742344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.52|||||TWO_SIDED|95.0|1.7|43.02||||||||43.02|1.70|
74096618|NCT01781481|147742345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.27|||||TWO_SIDED|95.0|2.17|24.36||||||||24.36|2.17|
74046515|NCT02033850|147645438|SUPERIORITY|||||||0.867|||||||t-test, 2 sided|||Δs on PCS (baseline vs 12 months)||||.867
74046516|NCT02033850|147645439|SUPERIORITY|||||||0.095|||||||Chi-squared|||MCS outcome (baseline vs 6 months)||||.095
74046517|NCT02033850|147645439|SUPERIORITY|||||||0.729|||||||Chi-squared|||MCS outcome (6 vs 12 months)||||.729
74046518|NCT02033850|147645439|SUPERIORITY|||||||0.115|||||||Chi-squared|||MCS outcome (baseline vs 12 months)||||.115
74046519|NCT02033850|147645439|SUPERIORITY|||||||0.576|||||||Chi-squared|||PCS outcome (baseline vs 6 months)||||.576
74046520|NCT02033850|147645439|SUPERIORITY|||||||0.191|||||||Chi-squared|||PCS outcome (6 vs 12 months)||||.191
74046521|NCT02033850|147645439|SUPERIORITY|||||||0.79|||||||Chi-squared|||PCS outcome (baseline vs 12 months)||||.790
74046522|NCT02033850|147645440|SUPERIORITY|||||||0.936|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 6 months)||||.936
74046523|NCT02033850|147645440|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||Δs on MoCA (6 vs 12 months)||||.188
74046524|NCT02033850|147645440|SUPERIORITY|||||||0.381|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 12 months)||||.381
74046525|NCT02033850|147645440|SUPERIORITY|||||||0.458|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 6 months)||||.458
74046526|NCT02033850|147645440|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||Δs on MMSE (6 vs 12 months)||||.236
74046527|NCT02033850|147645440|SUPERIORITY|||||||0.601|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 12 months)||||.601
74046528|NCT02033850|147645440|SUPERIORITY|||||||0.839|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 6 months)||||.839
74046529|NCT02033850|147645440|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|||Δs on RAVL immediate (6 vs 12 months)||||.021
74046530|NCT02033850|147645440|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 12 months)||||.032
74096619|NCT01781481|147742346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.79|||||TWO_SIDED|95.0|5.0|122.84||||||||122.84|5.00|
74096620|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Hospital Services involved in the child's care.||||<0.01
74096621|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Inpatient Hospitalizations since IBD diagnosis.||||<0.01
73880674|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|10.15||||0.0337|TWO_SIDED|95.0|1.2|86.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||86.09|1.20|0.0337
74018033|NCT00523991|147587611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.54||||0.916||95.0|-464.02|416.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||416.94|-464.02|0.916
74018034|NCT00523991|147587612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.42||||0.899||95.0|-520.19|457.34||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||457.34|-520.19|0.899
74018035|NCT00523991|147587613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|181.99||||0.495||95.0|-341.75|705.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||placebo versus tiotropium||705.73|-341.75|0.495
74018036|NCT00523991|147587614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|258.83||||0.318||95.0|-250.37|768.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||768.03|-250.37|0.318
74018037|NCT00523991|147587615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.18||||0.45||95.0|-338.04|760.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||760.39|-338.04|0.450
74018038|NCT00523991|147587616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.46||||0.858||95.0|-512.2|615.12||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||615.12|-512.20|0.858
74018039|NCT03285243|147587633|OTHER|||||||0.001||||||A priori, All p-values \< 0.05 were considered statistically significant.|Chi-squared|||||||0.001
74018040|NCT03285243|147587634|OTHER|||||||0.002||||||a priori, all p-values \< 0.05 were considered statistically significant.|Regression, Logistic|||||||0.002
74018041|NCT03175549|147587639|SUPERIORITY||Mean Difference (Final Values)|5.53|STANDARD_ERROR_OF_MEAN|10.1||0.36|TWO_SIDED|95.0|-10.22|29.38||A priori threshold for significance was 0.05.|Mixed Models Analysis||Standard error was calculated using bootstrap methods which is considered best for MEM.|||29.38|-10.22|0.36
74018042|NCT03175549|147587640|SUPERIORITY||Slope|-0.067|STANDARD_ERROR_OF_MEAN|0.03|<|0.025|TWO_SIDED||||||t-test, 2 sided|||Posted results show mean change in drinking for the drug group relative to placebo for each day of the 11 days of ad libidum drinking (Days 1-11) permitted during the 14 days (2 weeks) of medication.||||<0.025
74018043|NCT03175549|147587640|SUPERIORITY||Slope|-0.067|STANDARD_ERROR_OF_MEAN|0.03||0.025|TWO_SIDED||||||Mixed Models Analysis|473 daily observations within 43 individuals.|The apremilast group showed a significantly more rapid reduction in drinks per day relative to placebo.|||||0.025
74018044|NCT02435849|147587641|OTHER|testing the null hypothesis that ORR within 3 months is less than or equal to 20%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
74018045|NCT02435849|147587643|OTHER|testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
74018046|NCT02435849|147587644|OTHER|testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
74018047|NCT01017952|147587679|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.04|TWO_SIDED|95.0|0.66|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.99|0.66|0.040
74018048|NCT01017952|147587679|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.024|TWO_SIDED|95.0|0.64|0.97|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.97|0.64|0.024
74018049|NCT01017952|147587679|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69|||<|0.001|TWO_SIDED|95.0|0.56|0.85|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.85|0.56|<0.001
74018050|NCT01017952|147587680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.177|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox|||||1.06|0.71|0.177
74018051|NCT01017952|147587680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.036|TWO_SIDED|95.0|0.66|0.99|||Regression, Cox|||||0.99|0.66|0.036
74018052|NCT01017952|147587680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.82|||Regression, Cox|||||0.82|0.54|<0.001
74018053|NCT01017952|147587681|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.154|TWO_SIDED|95.0|0.65|1.07|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.07|0.65|0.154
74018054|NCT01017952|147587681|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.041|TWO_SIDED|95.0|0.6|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.99|0.60|0.041
74046531|NCT02033850|147645440|SUPERIORITY|||||||0.858|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 6 months)||||.858
74046532|NCT02033850|147645440|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||Δs on RAVL recall (6 vs 12 months)||||.212
74046533|NCT02033850|147645440|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 12 months)||||.268
74046534|NCT02033850|147645440|SUPERIORITY|||||||0.184|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 6 months)||||.184
74046535|NCT02033850|147645440|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||Δs on ROCF recall (6 vs 12 months)||||.358
74046536|NCT02033850|147645440|SUPERIORITY|||||||0.768|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 12 months)||||.768
74046537|NCT02033850|147645440|SUPERIORITY|||||||0.164|||||||t-test, 2 sided|||Δs on short story (baseline vs 6 months)||||.164
74046538|NCT02033850|147645440|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Δs on short story (6 vs 12 months)||||.420
74046539|NCT02033850|147645440|SUPERIORITY|||||||0.527|||||||t-test, 2 sided|||Δs on short story (baseline vs 12 months)||||.527
74046540|NCT02033850|147645440|SUPERIORITY|||||||0.762|||||||t-test, 2 sided|||Δs on visual search (baseline vs 6 months)||||.762
74046541|NCT02033850|147645440|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||Δs on visual search (6 vs 12 months)||||.405
74046542|NCT02033850|147645440|SUPERIORITY|||||||0.674|||||||t-test, 2 sided|||Δs on visual search (baseline vs 12 months)||||.674
74046543|NCT02033850|147645440|SUPERIORITY|||||||0.328|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 6 months)||||.328
74046544|NCT02033850|147645440|SUPERIORITY|||||||0.198|||||||t-test, 2 sided|||Δs on SDMT (6 vs 12 months)||||.198
74046545|NCT02033850|147645440|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 12 months)||||.639
74046546|NCT02033850|147645440|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 6 months)||||.098
74046547|NCT02033850|147645440|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||Δs on ROCF copy (6 vs 12 months)||||.235
74046548|NCT02033850|147645440|SUPERIORITY|||||||0.789|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 12 months)||||.789
74046549|NCT02033850|147645441|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 6 months)||||.743
74046550|NCT02033850|147645441|SUPERIORITY|||||||0.428|||||||t-test, 2 sided|||Δs on Stroop test (6 vs 12 months)||||.428
74046551|NCT02033850|147645441|SUPERIORITY|||||||0.294|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 12 months)||||.294
74046552|NCT02033850|147645441|SUPERIORITY|||||||0.157|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 6 months)||||.157
74046553|NCT02033850|147645441|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||Δs on TMT-A (6 vs 12 months)||||.094
74046554|NCT02033850|147645441|SUPERIORITY|||||||0.476|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 12 months)||||.476
74046555|NCT02033850|147645441|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 6 months)||||.142
74046556|NCT02033850|147645441|SUPERIORITY|||||||0.651|||||||t-test, 2 sided|||Δs on TMT-B (6 vs 12 months)||||.651
74046557|NCT02033850|147645441|SUPERIORITY|||||||0.534|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 12 months)||||.534
74046558|NCT02033850|147645442|SUPERIORITY|||||||0.882|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 6 months)||||.882
74046559|NCT02033850|147645442|SUPERIORITY|||||||0.835|||||||t-test, 2 sided|||Δs on phonemic fluency (6 vs 12 months)||||.835
74046560|NCT02033850|147645442|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 12 months)||||.951
74046561|NCT02033850|147645442|SUPERIORITY|||||||0.392|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 6 months)||||.392
74046562|NCT02033850|147645442|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||Δs on semantic fluency (6 vs 12 months)||||.973
74046563|NCT02033850|147645442|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 12 months)||||.486
74046564|NCT02033850|147645443|SUPERIORITY|||||||0.92|||||||Chi-squared|||MoCA variations (baseline vs 6 months)||||.920
74046565|NCT02033850|147645443|SUPERIORITY|||||||0.17|||||||Chi-squared|||MoCA variations (6 vs 12 months)||||.170
74046566|NCT02033850|147645443|SUPERIORITY|||||||0.716|||||||Chi-squared|||MoCA variations (baseline vs 12 months)||||.716
74046567|NCT02033850|147645443|SUPERIORITY|||||||0.973|||||||Chi-squared|||MMSE variations (baseline vs 6 months)||||.973
74046568|NCT02033850|147645443|SUPERIORITY|||||||0.973|||||||Chi-squared|||MMSE variations (6 vs 12 months)||||.973
74046569|NCT02033850|147645443|SUPERIORITY|||||||0.3|||||||Chi-squared|||MMSE variations (baseline vs 12 months)||||.300
74046570|NCT02033850|147645443|SUPERIORITY|||||||0.068|||||||Chi-squared|||RAVL immed. variations (baseline vs 6 months)||||.068
74046571|NCT02033850|147645443|SUPERIORITY|||||||0.089|||||||Chi-squared|||RAVL immed. variations (6 vs 12 months)||||.089
74046572|NCT02033850|147645443|SUPERIORITY|||||||0.241|||||||Chi-squared|||RAVL immed. variations (baseline vs 12 months)||||.241
74046573|NCT02033850|147645443|SUPERIORITY|||||||0.089|||||||Chi-squared|||RAVL recall variations (baseline vs 6 months)||||.089
74046574|NCT02033850|147645443|SUPERIORITY|||||||0.17|||||||Chi-squared|||RAVL recall variations (6 vs 12 months)||||.170
74046575|NCT02033850|147645443|SUPERIORITY|||||||0.413|||||||Chi-squared|||RAVL recall variations (baseline vs 12 months)||||.413
74046576|NCT02033850|147645443|SUPERIORITY|||||||0.777|||||||Chi-squared|||ROCF recall variations (baseline vs 6 months)||||.777
74046577|NCT02033850|147645443|SUPERIORITY|||||||0.134|||||||Chi-squared|||ROCF recall variations (6 vs 12 months)||||.134
74046578|NCT02033850|147645443|SUPERIORITY|||||||0.498|||||||Chi-squared|||ROCF recall variations (baseline vs 12 months)||||.498
74046579|NCT02033850|147645443|SUPERIORITY|||||||0.942|||||||Chi-squared|||Short story variations (baseline vs 6 months)||||.942
74046580|NCT02033850|147645443|SUPERIORITY|||||||0.578|||||||Chi-squared|||Short story variations (6 vs 12 months)||||.578
74046581|NCT02033850|147645443|SUPERIORITY|||||||0.413|||||||Chi-squared|||Short story variations (baseline vs 12 months)||||.413
74046582|NCT02033850|147645443|SUPERIORITY|||||||1|||||||Chi-squared|||Visual search variations (baseline vs 6 months)||||1
74046583|NCT02033850|147645443|SUPERIORITY|||||||0.038|||||||Chi-squared|||Visual search variations (6 vs 12 months)||||.038
74046584|NCT02033850|147645443|SUPERIORITY|||||||0.658|||||||Chi-squared|||Visual search variations (baseline vs 12 months)||||.658
74046585|NCT02033850|147645443|SUPERIORITY|||||||0.522|||||||Chi-squared|||SDMT variations (baseline vs 6 months)||||.522
74018055|NCT01017952|147587681|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65|||<|0.001|TWO_SIDED|95.0|0.51|0.84|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.84|0.51|<0.001
74046586|NCT02033850|147645443|SUPERIORITY|||||||0.674|||||||Chi-squared|||SDMT variations (6 vs 12 months)||||.674
74046587|NCT02033850|147645443|SUPERIORITY|||||||0.17|||||||Chi-squared|||SDMT variations (baseline vs 12 months)||||.170
74046588|NCT02033850|147645443|SUPERIORITY|||||||0.961|||||||Chi-squared|||Stroop test variations (baseline vs 6 months)||||.961
74046589|NCT02033850|147645443|SUPERIORITY|||||||0.413|||||||Chi-squared|||Stroop test variations (6 vs 12 months)||||.413
74046590|NCT02033850|147645443|SUPERIORITY|||||||0.477|||||||Chi-squared|||Stroop test variations (baseline vs 12 months)||||.477
74046591|NCT02033850|147645443|SUPERIORITY|||||||0.42|||||||Chi-squared|||TMT-A variations (baseline vs 6 months)||||.420
74046592|NCT02033850|147645443|SUPERIORITY|||||||0.241|||||||Chi-squared|||TMT-A variations (6 vs 12 months)||||.241
74046593|NCT02033850|147645443|SUPERIORITY|||||||0.295|||||||Chi-squared|||TMT-A variations (baseline vs 12 months)||||.295
74046594|NCT02033850|147645443|SUPERIORITY|||||||0.453|||||||Chi-squared|||TMT-B variations (baseline vs 6 months)||||.453
74046595|NCT02033850|147645443|SUPERIORITY|||||||0.952|||||||Chi-squared|||TMT-B variations (6 vs 12 months)||||.952
74046596|NCT02033850|147645443|SUPERIORITY|||||||0.881|||||||Chi-squared|||TMT-B variations (baseline vs 12 months)||||.881
74046597|NCT02033850|147645443|SUPERIORITY|||||||0.413|||||||Chi-squared|||Phonemic fluency variations (baseline vs 6 months)||||.413
74018056|NCT01017952|147587682|SUPERIORITY_OR_OTHER||Least squares mean difference|0.034||||0.034|TWO_SIDED|95.0|0.003|0.066||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.066|0.003|0.034
74018057|NCT01017952|147587682|SUPERIORITY_OR_OTHER||Least squares mean difference|0.024||||0.143|TWO_SIDED|95.0|-0.008|0.056|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.056|-0.008|0.143
74018058|NCT01017952|147587682|SUPERIORITY_OR_OTHER||Least squares mean difference|0.026||||0.115|TWO_SIDED|95.0|-0.006|0.057|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.057|-0.006|0.115
74046598|NCT02033850|147645443|SUPERIORITY|||||||0.961|||||||Chi-squared|||Phonemic fluency variations (6 vs 12 months)||||.961
74046599|NCT02033850|147645443|SUPERIORITY|||||||0.951|||||||Chi-squared|||Phonemic fluency variation (baseline vs 12 months)||||.951
74046600|NCT02033850|147645443|SUPERIORITY|||||||0.951|||||||Chi-squared|||Semantic fluency variations (baseline vs 6 months)||||.951
74046601|NCT02033850|147645443|SUPERIORITY|||||||0.674|||||||Chi-squared|||Semantic fluency variations (6 vs 12 months)||||.674
74046602|NCT02033850|147645443|SUPERIORITY|||||||0.951|||||||Chi-squared|||Semantic fluency variation (baseline vs 12 months)||||.951
74046603|NCT02033850|147645443|SUPERIORITY|||||||1|||||||Chi-squared|||ROCF copy variations (baseline vs 6 months)||||1
74046604|NCT02033850|147645443|SUPERIORITY|||||||0.027|||||||Chi-squared|||ROCF copy variations (6 vs 12 months)||||.027
74046605|NCT02033850|147645443|SUPERIORITY|||||||0.169|||||||Chi-squared|||ROCF copy variations (baseline vs 12 months)||||.169
74046606|NCT02033850|147645444|SUPERIORITY|||||||0.478|||||||Chi-squared|||||||.478
74046607|NCT02033850|147645445|SUPERIORITY|||||||0.029||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in vermis VIIIb||||0.029
74096622|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Surgeries since IBD diagnosis.||||<0.01
74096623|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Family Financial Well Being||||<0.01
74096624|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."||||>0.05
74018059|NCT01064167|147587683|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||Given that the frequency of RBC transfusion for OPCAB surgery is about 55%, to detect 35% reduction in TA group, with power=o.8 and α=0.05, a group of 107 patients in each arm is required. We estimated a crossover rate of 20%. The final sample size for randomization purposes increased to a total of 260 patients. The Chi-square test was used to test the differences in categorical variables between both groups.If one or more cells had an expected count less than 5, Fisher's Exact Test was used.||||<0.05
74018060|NCT01064167|147587684|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
74046608|NCT02033850|147645445|SUPERIORITY|||||||0.04||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in right VIIb lobule||||0.04
74046609|NCT02033850|147645445|SUPERIORITY|||||||0.039||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in left VIIb lobule||||0.039
74046610|NCT02820038|147645446|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8408|TWO_SIDED|95.0|0.52|2.24|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||2.24|0.52|0.8408
73880675|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.25||||0.2207|TWO_SIDED|95.0|0.61|8.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.24|0.61|0.2207
74046611|NCT02820038|147645446|SUPERIORITY||Odds Ratio (OR)|1.18||||0.58|TWO_SIDED|95.0|0.66|2.12|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or Other CMI+SMART, 1=DFB or DFB + SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.12|0.66|0.58
74046612|NCT02820038|147645446|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1937|TWO_SIDED|95.0|0.82|2.68|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||2.68|0.82|0.1937
74046613|NCT02820038|147645446|SUPERIORITY||Odds Ratio (OR)|2.379||||0.0193|TWO_SIDED|95.0|1.15|4.92|||Regression, Logistic|Sample restricted to participants who did not meet the criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who did not meet criteria for informed decision-making at baseline.||4.92|1.15|0.0193
74046614|NCT02820038|147645446|SUPERIORITY||Odds Ratio (OR)|0.53||||0.2216|TWO_SIDED|95.0|0.19|1.48|||Regression, Logistic||Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who met the criteria for informed decision-making at baseline.||1.48|0.19|0.2216
74046615|NCT02820038|147645447|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.83|STANDARD_ERROR_OF_MEAN|1.32||0.163|TWO_SIDED|95.0|-1.83|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.75|-1.83|0.1630
74046616|NCT02820038|147645447|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.05||0.7892|TWO_SIDED|95.0|-2.33|1.77|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|1.77|-2.33|0.7892
74046617|NCT02820038|147645447|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-2.19|STANDARD_ERROR_OF_MEAN|1.05||0.0377|TWO_SIDED|95.0|-4.25|-0.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||-0.13|-4.25|0.0377
74046618|NCT02820038|147645448|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.53||0.9216|TWO_SIDED|95.0|-0.98|1.08|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in values favorable to aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|1.08|-0.98|0.9216
74046619|NCT02820038|147645448|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.42||0.3843|TWO_SIDED|95.0|-0.45|1.17|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||1.17|-0.45|0.3843
74046620|NCT02820038|147645448|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.42||0.509|TWO_SIDED|95.0|-0.54|1.09|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.09|-0.54|0.5090
74096625|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||<0.01
74096626|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Surgeries since Diagnosis."||||<0.01
74096627|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Family Financial Well-Being."||||<0.01
74096628|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
74096629|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||>0.05
73880676|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.5||||0.0849|TWO_SIDED|95.0|0.84|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.57|0.84|0.0849
74096630|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Surgeries since child's diagnosis."||||>0.05
74096631|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Family Financial Well-Being."||||>0.05
74096632|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
74096633|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospitalizations since IBD Diagnosis."||||>0.05
74096634|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Surgeries since Child's IBD Diagnosis."||||>0.05
74096635|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Family Financial Well-Being."||||<0.01
74096636|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
74096637|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||>0.05
74096638|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Surgeries Child's IBD Diagnosis."||||>0.05
74096639|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Family Financial Well Being."||||>0.05
74096640|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospital Services Involved in the Child's Care."||||>0.05
74096641|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospitalizations since Child's IBD Diagnosis. Services Involved in the Child's Care."||||<0.01
74096642|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Surgeries since Child's IBD Diagnosis."||||>0.05
74096643|NCT01781481|147742347|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Family Financial Well-Being."||||<0.01
74096644|NCT01781481|147742348|SUPERIORITY_OR_OTHER||Rsquare change statistic|0.08|||<|0.01|TWO_SIDED|||||p\<0.05 Threshold for statistical significance|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
74096645|NCT01781481|147742349|SUPERIORITY_OR_OTHER||R2Change|0.05|||<|0.01|TWO_SIDED|||||Threshold for statistical significance is p\<0.01|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of calls to the IBD Nurse. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
74046621|NCT02820038|147645449|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.23||0.1486|TWO_SIDED|95.0|-0.77|0.12|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.12|-0.77|0.1486
74046622|NCT02820038|147645449|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.4888|TWO_SIDED|95.0|-0.47|0.22|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.22|-0.47|0.4888
74046623|NCT02820038|147645449|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.8637|TWO_SIDED|95.0|-0.32|0.38|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.38|-0.32|0.8637
74046624|NCT02820038|147645450|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.25||0.507|TWO_SIDED|95.0|-0.33|0.66|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.66|-0.33|0.5070
74046625|NCT02820038|147645450|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.19||0.4821|TWO_SIDED|95.0|-0.25|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.52|-0.25|0.4821
74046626|NCT02820038|147645450|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.7777|TWO_SIDED|95.0|-0.33|0.44|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.44|-0.33|0.7777
74046627|NCT02820038|147645451|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.64||0.6084|TWO_SIDED|95.0|-0.93|1.58|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.58|-0.93|0.6084
74046628|NCT02820038|147645451|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.5||0.597|TWO_SIDED|95.0|-0.71|1.23|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||1.23|-0.71|0.5970
74096646|NCT01781481|147742350|SUPERIORITY_OR_OTHER||Rsquare change statistic|0.05|||<|0.01|TWO_SIDED|||||p\<.05 threshold for statistical significance|Regression, Linear|Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of extra appointments with the IBD team. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3).||||<0.01
73880677|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.47||||0.0844|TWO_SIDED|95.0|0.84|14.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.24|0.84|0.0844
73888078|NCT01746901|147309534|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7307|TWO_SIDED|95.0|-1.9|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.7|-1.9|0.7307
74046629|NCT02820038|147645451|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.5||0.5094|TWO_SIDED|95.0|-0.65|1.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.31|-0.65|.5094
74046630|NCT02820038|147645452|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.48|STANDARD_ERROR_OF_MEAN|2.74||0.5866|TWO_SIDED|95.0|-6.85|3.89|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||3.89|-6.85|0.5866
74046631|NCT02820038|147645452|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|2.13||0.8689|TWO_SIDED|95.0|-3.82|4.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||4.52|-3.82|0.8689
74046632|NCT02820038|147645452|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|2.14||0.4356|TWO_SIDED|95.0|-2.53|5.86|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||5.86|-2.53|.4356
74046633|NCT02820038|147645453|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.48|STANDARD_ERROR_OF_MEAN|2.95||0.2366|TWO_SIDED|95.0|-2.3|9.26|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in self-efficacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||9.26|-2.30|0.2366
74046634|NCT02820038|147645453|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|2.29||0.8841|TWO_SIDED|95.0|-4.16|4.83|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||4.83|-4.16|0.8841
74046635|NCT02820038|147645453|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.45|STANDARD_ERROR_OF_MEAN|2.3||0.5264|TWO_SIDED|95.0|-3.05|5.95|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||5.95|-3.05|0.5264
74046636|NCT02820038|147645454|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|2.19||0.9604|TWO_SIDED|95.0|-4.4|4.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in medication adherence at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||4.18|-4.40|0.9604
74046637|NCT02820038|147645454|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-3.62|STANDARD_ERROR_OF_MEAN|1.64||0.0279|TWO_SIDED|95.0|-6.84|-0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in adherence between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||-0.40|-6.84|0.0279
74046638|NCT02820038|147645454|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.92|STANDARD_ERROR_OF_MEAN|1.66||0.0184|TWO_SIDED|95.0|0.67|7.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in medication adherence between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||7.18|0.67|0.0184
74046639|NCT02820038|147645455|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.73||0.3056|TWO_SIDED|95.0|-2.56|8.14|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in illness intrusiveness at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||8.14|-2.56|0.3056
74046640|NCT02820038|147645455|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|4.19|STANDARD_ERROR_OF_MEAN|2.11||0.0466|TWO_SIDED|95.0|0.06|8.32|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||8.32|0.06|0.0466
74046641|NCT02820038|147645455|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|2.11||0.9106|TWO_SIDED|95.0|-4.38|3.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||3.90|-4.38|0.9106
74096647|NCT01781481|147742351|SUPERIORITY_OR_OTHER||R2Change|0.03|||<|0.05|TWO_SIDED|||||Threshold for statistical significance is p \<0.05.|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of ER Visits. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.05
74018061|NCT00725075|147587685|SUPERIORITY_OR_OTHER||Mean Change From Baseline|-2.26||||0.267|TWO_SIDED|95.0|-6.25|1.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.||1.74|-6.25|0.267
74018062|NCT00725075|147587685|SUPERIORITY_OR_OTHER||Mean Change From Baseline|-0.08||||0.966|TWO_SIDED|95.0|-3.91|3.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.||3.74|-3.91|0.966
74018063|NCT00087646|147587721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.006|TWO_SIDED|95.0|1.21|3.31|||Cochran-Mantel-Haenszel|||Group A Vs Group D||3.31|1.21|0.0060
74018064|NCT00087646|147587722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9228|TWO_SIDED|95.0|0.63|1.51|||Cochran-Mantel-Haenszel|||||1.51|0.63|0.9228
74018065|NCT00087646|147587723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0006|TWO_SIDED|95.0|1.4|3.52|||Cochran-Mantel-Haenszel|||||3.52|1.40|0.0006
74018066|NCT00087646|147587724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.66|4.18|||Cochran-Mantel-Haenszel|||At Week 12||4.18|1.66|<.0001
74018067|NCT00087646|147587724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.1955|TWO_SIDED|95.0|0.89|1.79|||Cochran-Mantel-Haenszel|||At Week 24||1.79|0.89|0.1955
74018068|NCT00087646|147587724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0883|TWO_SIDED|95.0|0.95|1.93|||Cochran-Mantel-Haenszel|||At Week 48||1.93|0.95|0.0883
74018069|NCT00087646|147587725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.67|3.19|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 12)||3.19|1.67|<.0001
74018070|NCT00087646|147587725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.3389|TWO_SIDED|95.0|0.85|1.6|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 24)||1.60|0.85|0.3389
74018071|NCT01235962|147587729|SUPERIORITY||Adjusted Hazard Ratio|0.862||||0.1649|TWO_SIDED|95.0|0.699|1.063|||Stratified Log-Rank|||||1.063|0.699|0.1649
74018072|NCT01235962|147587730|SUPERIORITY||Adjusted Hazard Ratio|0.998||||0.988|TWO_SIDED|95.0|0.759|1.311|||Stratified Log-Rank|||||1.311|0.759|0.9880
74018073|NCT01235962|147587732|SUPERIORITY||Adjusted Hazard Ratio|0.802||||0.0126|TWO_SIDED|95.0|0.675|0.954|||Stratified Log-Rank|||||0.954|0.675|0.0126
74018074|NCT01235962|147587733|SUPERIORITY||Adjusted Hazard Ratio|1.001||||0.9959|TWO_SIDED|95.0|0.796|1.257|||Stratified Log-Rank|||||1.257|0.796|0.9959
74018075|NCT01235962|147587735|SUPERIORITY||Adjusted Hazard Ratio|0.693||||0.0201|TWO_SIDED|95.0|0.51|0.943|||Stratified Log-Rank|||||0.943|0.510|0.0201
74018076|NCT01235962|147587736|SUPERIORITY||Adjusted Hazard Ratio|1.004||||0.9865|TWO_SIDED|95.0|0.662|1.521|||Stratified Log-Rank|||||1.521|0.662|0.9865
74018077|NCT01235962|147587737|SUPERIORITY||Mean Difference (Week 52)|-3.397|||<|0.001|TWO_SIDED|95.0|-4.486|-2.307|||analysis of covariance|adjusted for baseline score using mixed-model||||-2.307|-4.486|<.001
74018078|NCT01235962|147587737|SUPERIORITY||Mean Difference (24M DFS FU)|-0.043||||0.93|TWO_SIDED|95.0|-1.003|0.917|||analysis of covariance|adjusted for baseline score using mixed-model||||0.917|-1.003|0.930
74018079|NCT01235962|147587737|SUPERIORITY||Mean Difference (36M DFS FU)|0.119||||0.828|TWO_SIDED|95.0|-0.958|1.196|||analysis of covariance|adjusted for baseline score using mixed-model||||1.196|-0.958|0.828
74018080|NCT01235962|147587737|SUPERIORITY||Mean Difference (48M DFS FU)|-0.347||||0.603|TWO_SIDED|95.0|-1.658|0.964|||analysis of covariance|adjusted for baseline score using mixed-model||||0.964|-1.658|0.603
74018081|NCT01235962|147587737|SUPERIORITY||Mean Difference (54M DFS FU)|-0.17||||0.841|TWO_SIDED|95.0|-1.843|1.503|||analysis of covariance|adjusted for baseline score using mixed-model||||1.503|-1.843|0.841
74018082|NCT01235962|147587738|SUPERIORITY||Mean Difference (Week 52)|-1.619|||<|0.001|TWO_SIDED|95.0|-2.283|-0.955|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.955|-2.283|<.001
73880678|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2383|TWO_SIDED|95.0|0.6|7.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.65|0.60|0.2383
73880679|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1653|TWO_SIDED|95.0|0.68|9.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.58|0.68|0.1653
73880680|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1836|TWO_SIDED|95.0|0.65|9.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.48|0.65|0.1836
73880681|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|8.3||||0.0529|TWO_SIDED|95.0|0.97|70.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||70.80|0.97|0.0529
73880682|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3197|TWO_SIDED|95.0|0.52|7.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.27|0.52|0.3197
73880683|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|5.88||||0.0376|TWO_SIDED|95.0|1.11|31.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||31.25|1.11|0.0376
73880684|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|10.08||||0.0343|TWO_SIDED|95.0|1.19|85.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||85.64|1.19|0.0343
73880685|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4435|TWO_SIDED|95.0|0.49|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.09|0.49|0.4435
73880686|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1805|TWO_SIDED|95.0|0.67|8.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.13|0.67|0.1805
73880687|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0857|TWO_SIDED|95.0|0.84|14.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.95|0.84|0.0857
74046642|NCT02820038|147645456|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.1762|TWO_SIDED|95.0|-0.57|0.1|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group..|The investigators hypothesized that participants would exhibit greater decreases in health distress at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.10|-0.57|0.1762
73880688|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|10.5||||0.0316|TWO_SIDED|95.0|1.23|89.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||89.63|1.23|0.0316
73880689|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.81||||0.3471|TWO_SIDED|95.0|0.52|6.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.27|0.52|0.3471
73880690|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|6.15||||0.0313|TWO_SIDED|95.0|1.18|32.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||32.09|1.18|0.0313
73880691|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|12.49||||0.0208|TWO_SIDED|95.0|1.47|106.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||106.3|1.47|0.0208
73880692|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8669|TWO_SIDED|95.0|0.31|3.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.97|0.31|0.8669
73880693|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.34||||0.6592|TWO_SIDED|95.0|0.37|4.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.89|0.37|0.6592
73880694|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.23||||0.2923|TWO_SIDED|95.0|0.5|9.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.98|0.50|0.2923
73880695|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|5.78||||0.1145|TWO_SIDED|95.0|0.65|51.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||51.04|0.65|0.1145
73880696|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.77||||0.447|TWO_SIDED|95.0|0.4|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.78|0.40|0.4470
73880697|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|7.31||||0.0753|TWO_SIDED|95.0|0.82|65.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||65.41|0.82|0.0753
73880698|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|6.85||||0.0829|TWO_SIDED|95.0|0.78|60.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||60.24|0.78|0.0829
73880699|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9978|TWO_SIDED|95.0|0.28|3.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.59|0.28|0.9978
74018083|NCT01235962|147587738|SUPERIORITY||Mean Difference (24 M DFS FU)|-0.114||||0.726|TWO_SIDED|95.0|-0.75|0.522|||analysis of covariance|adjusted for baseline score using mixed-model||||0.522|-0.750|0.726
74018084|NCT01235962|147587738|SUPERIORITY||Mean Difference (36 M DFS FU)|-0.09||||0.801|TWO_SIDED|95.0|-0.789|0.609|||analysis of covariance|adjusted for baseline score using mixed-model||||0.609|-0.789|0.801
74018085|NCT01235962|147587738|SUPERIORITY||Meat Difference (48 M DFS FU)|-0.212||||0.617|TWO_SIDED|95.0|-1.044|0.32|||analysis of covariance|adjusted for baseline score using mixed-model||||0.320|-1.044|0.617
74018086|NCT01235962|147587738|SUPERIORITY||Mean Difference (54 M DFS FU)|0.341||||0.565|TWO_SIDED|95.0|-0.828|1.51|||adjusted for baseline score using mixedm|||||1.510|-0.828|0.565
74018087|NCT01235962|147587739|SUPERIORITY||Mean Difference (Week 52)|-0.077||||0.238|TWO_SIDED|95.0|-0.205|0.051|||analysis of covariance|adjusted for baseline score using mixed-model||||0.051|-0.205|0.238
74018088|NCT01235962|147587739|SUPERIORITY||Mean Difference (24M DFS FU)|-0.052||||0.442|TWO_SIDED|95.0|-0.185|0.081|||analysis of covariance|adjusted for baseline score using mixed-model||||0.081|-0.185|0.442
74018089|NCT01235962|147587739|SUPERIORITY||Mean Difference (36M DFS FU)|0.016||||0.819|TWO_SIDED|95.0|-0.125|0.158|||analysis of covariance|adjusted for baseline score using mixed-model||||0.158|-0.125|0.819
74018090|NCT01235962|147587739|SUPERIORITY||Mean Difference (48M DFS FU)|-0.119||||0.223|TWO_SIDED|95.0|-0.311|0.073|||analysis of covariance|analysis of covariance adjusted for baseline score using mixed-model||||0.073|-0.311|0.223
74018091|NCT01235962|147587739|SUPERIORITY||Mean Difference (54M DFS FU)|-0.203||||0.085|TWO_SIDED|95.0|-0.435|0.028|||analysis of covariance|adjusted for baseline score using mixed-model||||0.028|-0.435|0.085
74018092|NCT01235962|147587740|SUPERIORITY||Mean Difference (Week 52)|-1.394|||<|0.001|TWO_SIDED|95.0|-1.66|-1.129|||analysis of covariance|adjusted for baseline score using mixed-model||||-1.129|-1.660|<.001
74018093|NCT01235962|147587740|SUPERIORITY||Mean difference (24M DFS FU)|0.117||||0.083|TWO_SIDED|95.0|-0.015|0.249|||analysis of covariance|adjusted for baseline score using mixed-model||||0.249|-0.015|0.083
74018094|NCT01235962|147587740|SUPERIORITY||Mean Difference (36M DFS FU)|0.081||||0.307|TWO_SIDED|95.0|-0.074|0.236|||analysis of covariance|adjusted for baseline score using mixed-model||||0.236|-0.074|0.307
74018095|NCT01235962|147587740|SUPERIORITY||Mean Difference (48M DFS FU)|-0.029||||0.796|TWO_SIDED|95.0|-0.249|0.191|||analysis of covariance|adjusted for baseline score using mixed-model||||0.191|-0.249|0.796
74018096|NCT01235962|147587740|SUPERIORITY||Mean Difference (54M DFS FU)|-0.016||||0.885|TWO_SIDED|95.0|-0.237|0.205|||analysis of covariance|adjusted for baseline score using mixed-models||||0.205|-0.237|0.885
74018097|NCT01235962|147587741|SUPERIORITY||Mean Differencec (Week 52)|-0.27||||0.143|TWO_SIDED|95.0|-0.633|0.092|||analysis of covariance|adjusted for baseline score using mixed-model||||0.092|-0.633|0.143
74018098|NCT01235962|147587741|SUPERIORITY||Mean Difference (24M DFS FU)|0.069||||0.736|TWO_SIDED|95.0|-0.336|0.475|||analysis of covariance|adjusted for baseline score using mixed-model||||0.475|-0.336|0.736
74018099|NCT01235962|147587741|SUPERIORITY||Mean Difference (36M DFS FU)|0.188||||0.397|TWO_SIDED|95.0|-0.247|0.623|||analysis of covariance|adjusted for baseline score using mixed-model||||0.623|-0.247|0.397
74018100|NCT01235962|147587741|SUPERIORITY||Mean Difference (48M DFS FU)|0.081||||0.781|TWO_SIDED|95.0|-0.488|0.649|||analysis of covariance|adjusted for baseline score using mixed-model||||0.649|-0.488|0.781
74018101|NCT01235962|147587741|SUPERIORITY||Mean Difference (54M DFS FU)|-0.278||||0.503|TWO_SIDED|95.0|-1.094|0.539|||analysis of covariance|adjusted for baseline score using mixed-model||||0.539|-1.094|0.503
74018102|NCT01235962|147587742|SUPERIORITY||Mean Difference (Week 52 thermo)|-0.717||||0.49|TWO_SIDED|95.0|-2.751|1.318|||analysis of covariance|adjusted for baseline score using mixed-model||||1.318|-2.751|0.490
74018103|NCT01235962|147587742|SUPERIORITY||Mean Difference (24M DFS FU- thermo)|-0.285||||0.788|TWO_SIDED|95.0|-2.358|1.788|||analysis of covariance|adjusted for baseline score using mixed-model||||1.788|-2.358|0.788
74018104|NCT01235962|147587742|SUPERIORITY||Mean Difference (36M DFS FU- thermo)|1.18||||0.266|TWO_SIDED|95.0|-0.901|3.262|||analysis of covariance|adjusted for baseline score using mixed-model||||3.262|-0.901|0.266
74018105|NCT01235962|147587742|SUPERIORITY||Mean Difference (48M DFS FU - thermo)|0.725||||0.57|TWO_SIDED|95.0|-1.779|3.229|||analysis of covariance|adjusted for baseline score using mixed-model||||3.229|-1.779|0.570
74096648|NCT01781481|147742352|SUPERIORITY_OR_OTHER||R2Change|0.07|||<|0.01|TWO_SIDED||||||Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
73880700|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.68||||0.4571|TWO_SIDED|95.0|0.43|6.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.65|0.43|0.4571
74096649|NCT00642694|147742376|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
74096650|NCT03688282|147742385|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74096651|NCT01007942|147742404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0067|TWO_SIDED|95.0|0.65|0.95|||Log Rank|||||0.95|0.65|0.0067
74096652|NCT00806286|147742430|SUPERIORITY||Mean Difference (Final Values)|-23.2|||<|0.0001|TWO_SIDED|||||Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Z-test||The estimated value represents the difference in treatments (%).|||||<0.0001
74096653|NCT00806286|147742430|SUPERIORITY||Cox Proportional Hazard|1.579||||0.0499|TWO_SIDED|95.0|1.0|2.5|||Regression, Cox|||||2.5|1.0|0.0499
74096654|NCT00806286|147742431|SUPERIORITY|Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Mean Difference (Final Values)|-25.5|||<|0.0001|TWO_SIDED||||||Z-test||The estimated value represents the difference in treatments (%).|||||<0.0001
74096655|NCT03469336|147742440|OTHER|Ratio|Mean Ratio (Test/Reference)|1.0109|STANDARD_ERROR_OF_MEAN|0.732||0.9883|TWO_SIDED|95.0|0.2364|4.3226|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.3226|0.2364|0.9883
74096656|NCT03469336|147742440|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9979|STANDARD_ERROR_OF_MEAN|0.732||0.9977|TWO_SIDED|95.0|0.2334|4.2671|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.2671|0.2334|0.9977
74096657|NCT03469336|147742440|OTHER|Ratio|Mean Ratio (Test/Reference)|1.1382|STANDARD_ERROR_OF_MEAN|0.732||0.86|TWO_SIDED|95.0|0.2662|4.867|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.8670|0.2662|0.8600
73880701|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.99||||0.3681|TWO_SIDED|95.0|0.44|8.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.94|0.44|0.3681
73880702|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|6.12||||0.1038|TWO_SIDED|95.0|0.69|54.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||54.38|0.69|0.1038
74018106|NCT01235962|147587742|SUPERIORITY||Mean Difference (54M DFS FU - thermo)|2.023||||0.346|TWO_SIDED|95.0|-2.205|6.251|||analysis of covariance|adjusted for baseline score using mixed-model||||6.251|-2.205|0.346
74018107|NCT01235962|147587742|SUPERIORITY||Mean Difference (Week 52 - UI)|-0.018||||0.111|TWO_SIDED|95.0|-0.04|0.004|||analysis of covariance|adjusted for baseline score using mixed-model||||0.004|-0.040|0.111
74096658|NCT03469336|147742445|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9979|STANDARD_ERROR_OF_MEAN|0.071||0.9763|TWO_SIDED|95.0|0.8588|1.1594|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.1594|0.8588|0.9763
74096659|NCT03469336|147742445|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9664|STANDARD_ERROR_OF_MEAN|0.051||0.5081|TWO_SIDED|95.0|0.8686|1.0752|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.0752|0.8686|0.5081
74096660|NCT03469336|147742445|OTHER|Ratio|Mean Ratio (Test/Reference)|1.1155|STANDARD_ERROR_OF_MEAN|0.044||0.0249|TWO_SIDED|95.0|1.0157|1.2252|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.2252|1.0157|0.0249
74096661|NCT03469336|147742446|OTHER|Ratio|Mean Ratio (Test/Reference)|0.7946|STANDARD_ERROR_OF_MEAN|0.732||0.754|TWO_SIDED|95.0|0.1858|3.3977|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.3977|0.1858|0.7540
74096662|NCT03469336|147742446|OTHER|Ratio|Mean Ratio (Test/Reference)|0.7844|STANDARD_ERROR_OF_MEAN|0.732||0.7407|TWO_SIDED|95.0|0.1834|3.354|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.3540|0.1834|0.7407
74096663|NCT03469336|147742446|OTHER|Ratio|Mean Ratio (Test/Reference)|0.8946|STANDARD_ERROR_OF_MEAN|0.732||0.8793|TWO_SIDED|95.0|0.2092|3.8256|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.8256|0.2092|0.8793
73880703|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4639|TWO_SIDED|95.0|0.39|7.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.72|0.39|0.4639
74046643|NCT02820038|147645456|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4186|TWO_SIDED|95.0|-0.36|0.15|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.15|-0.36|0.4186
74046644|NCT02820038|147645456|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8848|TWO_SIDED|95.0|-0.28|0.24|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.24|-0.28|0.8848
74046645|NCT02820038|147645457|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6403|TWO_SIDED|95.0|-0.15|0.25|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in health status at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.25|-0.15|0.6403
74046646|NCT02820038|147645457|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.8766|TWO_SIDED|95.0|-0.14|0.16|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in global health status between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.16|-0.14|0.8766
74046647|NCT02820038|147645457|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.08||0.7603|TWO_SIDED|95.0|-0.13|0.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater improvement in global health status between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.18|-0.13|0.7603
74046648|NCT02820038|147645458|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7093|TWO_SIDED|95.0|-0.43|0.63|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in disease activity at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.63|-0.43|0.7093
74046649|NCT02820038|147645458|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.21||0.5941|TWO_SIDED|95.0|-0.3|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.52|-0.30|0.5941
74046650|NCT02820038|147645458|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.9476|TWO_SIDED|95.0|-0.42|0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.40|-0.42|0.9476
74096664|NCT03469336|147742447|OTHER|Ratio|Mean Ratio (Test/Reference)|1.081321|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.25287|4.623941|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||4.623941|0.25287|<0.0001
73880704|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|7.15||||0.077|TWO_SIDED|95.0|0.81|63.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||63.27|0.81|0.0770
73880705|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9838|TWO_SIDED|95.0|0.26|4.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.01|0.26|0.9838
73880706|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|0.77||||0.6995|TWO_SIDED|95.0|0.21|2.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.86|0.21|0.6995
73880707|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8808|TWO_SIDED|95.0|0.26|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.71|0.26|0.8808
73880708|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|4.94||||0.157|TWO_SIDED|95.0|0.54|45.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||45.13|0.54|0.1570
74046651|NCT02820038|147645459|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.8||0.9128|TWO_SIDED|95.0|-1.65|1.48|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in depression at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.48|-1.65|0.9128
74046652|NCT02820038|147645459|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.62||0.6312|TWO_SIDED|95.0|-1.5|0.91|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.91|-1.50|0.6312
74046653|NCT02820038|147645459|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.62||0.5766|TWO_SIDED|95.0|-1.57|0.87|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.87|-1.57|0.5766
73880709|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.19||||0.3742|TWO_SIDED|95.0|0.39|12.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.26|0.39|0.3742
73888079|NCT01746901|147309534|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.5473|TWO_SIDED|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-3.0|0.5473
74018108|NCT01235962|147587742|SUPERIORITY||Mean Difference (24M DFS FU - UI)|-0.02||||0.094|TWO_SIDED|95.0|-0.044|0.003|||analysis of covariance|adjusted for baseline score using mixed-model||||0.003|-0.044|0.094
74018109|NCT01235962|147587742|SUPERIORITY||Mean Difference (36M DFS FU - UI)|0.01||||0.49|TWO_SIDED|95.0|-0.018|0.037|||analysis of covariance|adjusted for baseline score using mixed-model||||0.037|-0.018|0.490
74018110|NCT01235962|147587742|SUPERIORITY||Mean Difference (48M DFS FU - UI)|-0.009||||0.58|TWO_SIDED|95.0|-0.043|0.024|||analysis of covariance|adjusted for baseline score using mixed-model||||0.024|-0.043|0.580
74018111|NCT01235962|147587742|SUPERIORITY||Mean Difference (54M DFS FU - UI)|0.017||||0.473|TWO_SIDED|95.0|-0.029|0.063|||analysis of covariance|adjusted for baseline score using mixed-model||||0.063|-0.029|0.473
74046654|NCT02820038|147645460|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|1.04||0.2123|TWO_SIDED|95.0|-3.34|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in fatigue at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.75|-3.34|0.2123
74046655|NCT02820038|147645460|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.81||0.2691|TWO_SIDED|95.0|-2.48|0.7|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.70|-2.48|0.2691
74046656|NCT02820038|147645460|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.81||0.5655|TWO_SIDED|95.0|-2.06|1.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.13|-2.06|0.5655
73880710|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|5.24||||0.1436|TWO_SIDED|95.0|0.57|48.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||48.26|0.57|0.1436
74046657|NCT02820038|147645461|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|4.1||0.5364|TWO_SIDED|95.0|-5.51|10.55|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in health literacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||10.55|-5.51|0.5364
74046658|NCT02820038|147645461|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|3.24||0.605|TWO_SIDED|95.0|-4.68|8.01|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||8.01|-4.68|0.6050
74046659|NCT02820038|147645461|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|3.24||0.924|TWO_SIDED|95.0|-6.66|6.05|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||6.05|-6.66|0.9240
74046660|NCT02820038|147645462|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7871|TWO_SIDED|95.0|0.43|1.89|||Regression, Logistic||Modeled probability of attending at least one class session. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to participate in the BetterChoices, BetterHealth program if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.89|0.43|0.7871
74046661|NCT02820038|147645462|SUPERIORITY||Odds Ratio (OR)|1.189||||0.5815|TWO_SIDED|95.0|0.643|2.198|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices,BetterHealth program if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.198|0.643|0.5815
74046662|NCT02820038|147645462|SUPERIORITY||Odds Ratio (OR)|0.679||||0.2211|TWO_SIDED|95.0|0.366|1.262|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices, BetterHealth program if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.262|0.366|0.2211
74046663|NCT02820038|147645463|SUPERIORITY||Odds Ratio (OR)|0.804||||0.574|TWO_SIDED|95.0|0.38|1.72|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to use the RA Self-Management website if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.72|0.38|0.5740
74046664|NCT02820038|147645463|SUPERIORITY||Odds Ratio (OR)|1.425||||0.1278|TWO_SIDED|95.0|0.766|2.649|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.649|0.766|0.1278
74046665|NCT02820038|147645463|SUPERIORITY||Odds Ratio (OR)|0.614||||0.1278|TWO_SIDED|95.0|0.328|1.15|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.15|0.328|0.1278
74096665|NCT03469336|147742447|OTHER|Ratio|Mean Ratio (Test/Reference)|1.067453|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.249631|4.564555|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||4.564555|0.249631|<0.0001
74096666|NCT03469336|147742447|OTHER|Ratio|Mean Ratio (Test/Reference)|1.217483|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.284708|5.206258|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||5.206258|0.284708|<0.0001
74096667|NCT00289536|147742478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1662|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log initial recovery will be the same in each dose group.||||0.1662
74096668|NCT00289536|147742479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0965||||||No adjustments were made for multiple comparisons.|ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log AUC/dose will be the same in each dose group.||||0.0965
74096669|NCT00289536|147742480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5057|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean terminal half-life will be the same in each dose group.||||0.5057
73880711|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|5.57||||0.1277|TWO_SIDED|95.0|0.61|50.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||50.77|0.61|0.1277
73880712|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6689|TWO_SIDED|95.0|0.2|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.81|0.20|0.6689
73880713|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.2||||0.8019|TWO_SIDED|95.0|0.29|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.95|0.29|0.8019
74046666|NCT02820038|147645464|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|11.9|STANDARD_ERROR_OF_MEAN|8.7||0.17|TWO_SIDED|95.0|-5.2|28.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||28.9|-5.2|0.17
74046667|NCT02820038|147645464|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable|Mean Difference (Net)|16.0|STANDARD_ERROR_OF_MEAN|6.9||0.02|TWO_SIDED|95.0|2.5|29.5|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||29.5|2.5|0.02
74046668|NCT02820038|147645464|SUPERIORITY|Regression model adjusted for baseline values of the dependent variable.|Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|6.9||0.42|TWO_SIDED|95.0|-8.1|19.2|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||19.2|-8.1|0.42
74046669|NCT02820038|147645465|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.15||0.15|TWO_SIDED|95.0|-5.2|0.8|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.8|-5.2|0.15
74046670|NCT02820038|147645465|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.2||0.07|TWO_SIDED|95.0|-4.4|0.3|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.3|-4.4|0.07
74046671|NCT02820038|147645465|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.13|TWO_SIDED|95.0|-4.2|0.6|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.6|-4.2|0.13
74046672|NCT02820038|147645466|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.12||0.68|TWO_SIDED|95.0|-0.19|0.29|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.29|-0.19|0.68
74046673|NCT02820038|147645466|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2|TWO_SIDED|95.0|-0.06|0.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.31|-0.06|0.20
73880714|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9591|TWO_SIDED|95.0|0.23|4.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.05|0.23|0.9591
73880715|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.33||||0.3364|TWO_SIDED|95.0|0.42|13.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.06|0.42|0.3364
74046674|NCT02820038|147645466|SUPERIORITY||Mean Difference (Net)|0.001|STANDARD_ERROR_OF_MEAN|0.1||0.99|TWO_SIDED|95.0|-0.19|0.19|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-week follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.19|-0.19|0.99
74046675|NCT02820038|147645467|SUPERIORITY||Odds Ratio (OR)|2.105||||0.0028|TWO_SIDED|95.0|1.291|3.432|||Regression, Logistic|||The investigators hypothesized that participants would be more likely to view at least one webpage if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Modeled probability of viewing at least one webpage. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|3.432|1.291|0.0028
74046676|NCT02820038|147645468|SUPERIORITY||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|0.45||0.0601|TWO_SIDED|95.0|-1.71|0.04|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would view more webpages if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.04|-1.71|0.0601
74046677|NCT02820038|147645469|SUPERIORITY||Odds Ratio (OR)|0.91||||0.9|TWO_SIDED|95.0|0.22|3.81|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to be using at least one DMARD (Disease-Modifying Antirheumatic Drug) at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||3.81|0.22|0.90
74046678|NCT02820038|147645469|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|0.75||||0.63|TWO_SIDED|95.0|0.24|2.35|||Regression, Logistic||. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART; 1=DFB Only, DFB+SMART|The investigators hypothesized that participants would exhibit a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.35|0.24|0.63
74046679|NCT02820038|147645469|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|1.15||||0.81|TWO_SIDED|95.0|0.37|3.54|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, DrugFactsBox® (DFB) Only; 1=Other CMI+SMART, DFB+SMART|The investigators hypothesized that participants would experience a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||3.54|0.37|0.81
74046680|NCT02512276|147645505|SUPERIORITY||Mean Difference (Net)|4.7|||||TWO_SIDED|95.0|3.0|6.4||||||||6.4|3.0|
74046681|NCT02512276|147645506|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.91|1.22||||||||1.22|0.91|
74046682|NCT02512276|147645507|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.94|1.28||||||||1.28|0.94|
74046683|NCT02512276|147645508|SUPERIORITY||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.45|0.85||||||||0.85|0.45|
74046684|NCT02512276|147645509|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||||1.36|0.91|
74046685|NCT02512276|147645510|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.78|1.34||||||||1.34|0.78|
74046686|NCT02725268|147645584|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.178|TWO_SIDED|95.0|0.58|1.12||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.12|0.58|=0.178
74046687|NCT02725268|147645584|SUPERIORITY||Hazard Ratio (HR)|1.85|||=|0.092|TWO_SIDED|95.0|1.19|2.86||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.86|1.19|=0.092
73888080|NCT01746901|147309534|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.4999|TWO_SIDED|95.0|-3.1|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-3.1|0.4999
74046688|NCT02725268|147645584|SUPERIORITY||Hazard Ratio (HR)|2.57|||=|0.147|TWO_SIDED|95.0|1.47|4.49||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||4.49|1.47|=0.147
74046689|NCT02725268|147645586|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.968|TWO_SIDED|95.0|0.72|1.5||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.50|0.72|=0.968
73880716|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.2||||0.3698|TWO_SIDED|95.0|0.39|12.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.32|0.39|0.3698
74096670|NCT00289536|147742488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7048||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: Relationship of initial recovery to pre-infusion level of VWF:Rco with dose groups combined.||||0.7048
73880717|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|4.92||||0.1587|TWO_SIDED|95.0|0.54|45.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||45.01|0.54|0.1587
74096671|NCT00289536|147742488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0322||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Rco with dose groups combined.||||.0322
74096672|NCT00289536|147742488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Rco with dose groups combined.||||0.0056
74096673|NCT00289536|147742489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3696||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of initial recovery to pre-infusion level of VWF:Ag with dose groups combined.||||0.3696
74096674|NCT00289536|147742489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Ag with dose groups combined.||||0.0001
74096675|NCT00289536|147742489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Ag with dose groups combined.||||<0.0001
74096676|NCT00265395|147742516|SUPERIORITY_OR_OTHER||SVR Rate Difference|-4.9||||0.6445||95.0|-20.4|10.6|||Asymptotic Z-test|||||10.6|-20.4|0.6445
74096677|NCT01955837|147742517|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.035|TWO_SIDED|95.0|0.62|0.99|||Log Rank|||||0.99|0.62|0.035
74096678|NCT01955837|147742518|SUPERIORITY||Hazard Ratio (HR)|0.43|||<|0.001|TWO_SIDED|95.0|0.34|0.54|||Log Rank|||||0.54|0.34|<0.001
74096679|NCT01955837|147742519|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.37|0.58|||Log Rank|||||0.58|0.37|<0.001
74096680|NCT01955837|147742520|SUPERIORITY||Difference in ORR|1.1||||0.554|TWO_SIDED|95.0|-0.1|2.4|||Fisher Exact|||||2.4|-0.1|0.554
74096681|NCT01955837|147742521|SUPERIORITY||Difference in DCR|29.4|||<|0.001|TWO_SIDED|95.0|20.9|38.0|||Fisher Exact|||||38.0|20.9|<0.001
74096682|NCT01955837|147742522|SUPERIORITY||Odds Ratio (OR)|29.4|||<|0.001|TWO_SIDED|95.0|20.9|38.0|||Fisher Exact|||||38.0|20.9|<0.001
74096683|NCT01955837|147742525|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.083|TWO_SIDED|95.0|0.57|1.04|||Log Rank|||||1.04|0.57|0.083
74096684|NCT01955837|147742526|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.228|TWO_SIDED|95.0|0.57|1.2|||Log Rank|||||1.20|0.57|0.228
74096685|NCT01955837|147742527|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.32|0.59||||||||0.59|0.32|
74096686|NCT01955837|147742528|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.31|0.65||||||||0.65|0.31|
74018112|NCT01235962|147587743|SUPERIORITY||Mean Difference (Week 52)|-3.536|||<|0.001|TWO_SIDED|95.0|-4.466|-2.606|||analysis of covariance|adjusted for baseline score using mixed-model||||-2.606|-4.466|<.001
74096687|NCT00552578|147742536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17||||0.523||95.0|0.0098|2.8215|||Fisher Exact|||Intent to treat||2.8215|0.0098|0.523
74096688|NCT00552578|147742538|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||No adjustment|Fisher Exact|||Fisher exact test was used and tested the hypothesis that neither group would be more likely to complete the study protocol.||||0.015
74096689|NCT02338193|147742544|SUPERIORITY||||||<|0.032|||||||ANOVA|||One Way ANOVA with Bonferroni contrast if p\>0.05||||<0.032
74096690|NCT02338193|147742545|SUPERIORITY||||||<|0.05|||||||ANOVA|One Way ANOVA with Bonferoni contrast test||||||<0.05
74096691|NCT02338193|147742546|SUPERIORITY||||||<|0.01|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.01
74096692|NCT02338193|147742547|SUPERIORITY||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.012
74096693|NCT02338193|147742548|SUPERIORITY|||||||0.007|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.007
74096694|NCT02338193|147742549|SUPERIORITY|||||||0.023|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||0.023
74096695|NCT02338193|147742550|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||>0.05
74096696|NCT02338193|147742551|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||>0.05
74096697|NCT02338193|147742552|SUPERIORITY||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||<0.001
74018113|NCT01235962|147587743|SUPERIORITY||Mean difference (24M DFS FU)|-0.102||||0.812|TWO_SIDED|95.0|-0.942|0.738|||analysis of covariance|adjusted for baseline score using mixed-model||||0.738|-0.942|0.812
74018114|NCT01235962|147587743|SUPERIORITY||Mean Difference (36M DFS FU)|0.233||||0.621|TWO_SIDED|95.0|-0.69|1.155|||analysis of covariance|adjusted for baseline score using mixed-model||||1.155|-0.690|0.621
74018115|NCT01235962|147587743|SUPERIORITY||Mean Difference (48M DFS FU)|0.082||||0.878|TWO_SIDED|95.0|-0.959|1.122|||analysis of covariance|adjusted for baseline score using mixed-model||||1.122|-0.959|0.878
74018116|NCT01235962|147587743|SUPERIORITY||Mean Difference (54M DFS FU)|0.412||||0.533|TWO_SIDED|95.0|-0.887|1.712|||analysis of covariance|adjusted for baseline score using mixed-model||||1.712|-0.887|0.533
74018117|NCT01235962|147587744|SUPERIORITY||Mean Difference (Week 52)|-1.515|||<|0.001|TWO_SIDED|95.0|-2.078|-0.952|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.952|-2.078|<.001
74096698|NCT02338193|147742553|SUPERIORITY||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.001
74096699|NCT02338193|147742554|SUPERIORITY||||||<|0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.004
74096700|NCT02338193|147742555|SUPERIORITY||||||<|0.02|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.02
74018118|NCT01235962|147587744|SUPERIORITY||Mean Difference (24M DFS FU)|0.014||||0.961|TWO_SIDED|95.0|-0.534|0.561|||analysis of covariance|adjusted for baseline score using mixed-model||||0.561|-0.534|0.961
74096701|NCT02338193|147742556|SUPERIORITY||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.012
74096702|NCT02338193|147742557|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||>0.05
74096703|NCT02338193|147742558|SUPERIORITY||||||<|0.028|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.028
74096704|NCT02338193|147742559|SUPERIORITY||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<.03
74018119|NCT01235962|147587744|SUPERIORITY||Mean Difference (36M DFS FU)|0.043||||0.888|TWO_SIDED|95.0|-0.555|0.641|||analysis of covariance|adjusted for baseline score using mixed-model||||0.641|-0.555|0.888
74018120|NCT01235962|147587744|SUPERIORITY||Mean Difference (48M DFS FU)|-0.061||||0.858|TWO_SIDED|95.0|-0.736|0.614|||analysis of covariance|adjusted for baseline score using mixed-model||||0.614|-0.736|0.858
74018121|NCT01235962|147587744|SUPERIORITY||Mean Difference (54M DFS FU)|0.452||||0.3|TWO_SIDED|95.0|-0.404|1.309|||analysis of covariance|adjusted for baseline score using mixed-model||||1.309|-0.404|0.300
74018122|NCT01235962|147587745|SUPERIORITY||Mean Difference (Week 52)|-0.103||||0.059|TWO_SIDED|95.0|-0.211|0.004|||analysis of covariance|adjusted for baseline score using mixed-model||||0.004|-0.211|0.059
74018123|NCT01235962|147587745|SUPERIORITY||Mean Difference (24M DFS FU)|-0.041||||0.487|TWO_SIDED|95.0|-0.155|0.074|||analysis of covariance|adjusted for baseline score using mixed-model||||0.074|-0.155|0.487
74018124|NCT01235962|147587745|SUPERIORITY||Mean Difference (36M DFS FU)|0.037||||0.885|TWO_SIDED|95.0|-0.085|0.16|||analysis of covariance|adjusted for baseline score using mixed-model||||0.160|-0.085|0.885
74018125|NCT01235962|147587745|SUPERIORITY||Mean Difference (48M DFS FU)|-0.032||||0.676|TWO_SIDED|95.0|-0.183|0.119|||analysis of covariance|adjusted for baseline score using mixed-model||||0.119|-0.183|0.676
74018126|NCT01235962|147587745|SUPERIORITY||Mean Difference (54M DFS FU)|-0.015||||0.859|TWO_SIDED|95.0|-0.183|0.153|||analysis of covariance|adjusted for baseline score using mixed-model||||0.153|-0.183|0.859
74018127|NCT01235962|147587746|SUPERIORITY||Mean Diffeence (Week 52)|-1.535|||<|0.001|TWO_SIDED|95.0|-1.769|-1.3|||analysis of covariance|adjusted for baseline score using mixed-model||||-1.300|-1.769|<.001
74018128|NCT01235962|147587746|SUPERIORITY||Mean Diffeence (24M DFS FU)|0.089||||0.127|TWO_SIDED|95.0|-0.025|0.202|||analysis of covariance|adjusted for baseline score using mixed-model||||0.202|-0.025|0.127
74018129|NCT01235962|147587746|SUPERIORITY||Mean Diffeence (36M DFS FU)|0.123||||0.069|TWO_SIDED|95.0|-0.009|0.255|||analysis of covariance|adjusted for baseline score using mixed-model||||0.255|-0.009|0.069
74018130|NCT01235962|147587746|SUPERIORITY||Mean Diffeence (48M DFS FU)|0.049||||0.544|TWO_SIDED|95.0|-0.11|0.208|||analysis of covariance|adjusted for baseline score using mixed-model||||0.208|-0.110|0.544
74018131|NCT01235962|147587746|SUPERIORITY||Mean Difference (54M DFS FU)|0.061||||0.518|TWO_SIDED|95.0|-0.124|0.246|||analysis of covariance|adjusted for baseline score using mixed-model||||0.246|-0.124|0.518
74018132|NCT01235962|147587747|SUPERIORITY||Mean Diffeence (Week 52)|-0.374||||0.022|TWO_SIDED|95.0|-0.695|-0.053|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.053|-0.695|0.022
74018133|NCT01235962|147587747|SUPERIORITY||Mean Diffeence (24M DFS FU)|-0.104||||0.567|TWO_SIDED|95.0|-0.462|0.253|||analysis of covariance|adjusted for baseline score using mixed-model||||0.253|-0.462|0.567
74018134|NCT01235962|147587747|SUPERIORITY||Mean Difference (36M DFS FU)|0.072||||0.706|TWO_SIDED|95.0|-0.302|0.446|||analysis of covariance|adjusted for baseline score using mixed-model||||0.446|-0.302|0.706
74018135|NCT01235962|147587747|SUPERIORITY||Mean Difference (48M DFS FU)|0.12||||0.612|TWO_SIDED|95.0|-0.343|0.583|||analysis of covariance|adjusted for baseline score using mixed-model||||0.583|-0.343|0.612
74018136|NCT01235962|147587747|SUPERIORITY||Mean Difference (54M DFS FU)|-0.045||||0.87|TWO_SIDED|95.0|-0.587|0.496|||analysis of covariance|adjusted for baseline score using mixed-model||||0.496|-0.587|0.870
74018137|NCT01235962|147587748|SUPERIORITY||Mean Difference (Week 52 - thermo.)|-2.116||||0.018|TWO_SIDED|95.0|-3.872|-0.359|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.359|-3.872|0.018
74018138|NCT01235962|147587748|SUPERIORITY||Mean Difference (24M DFS FU - thermo)|-0.253||||0.778|TWO_SIDED|95.0|-2.014|1.508|||analysis of covariance|adjusted for baseline score using mixed-model||||1.508|-2.014|0.778
74018139|NCT01235962|147587748|SUPERIORITY||Mean Difference (36M DFS FU - thermo)|0.847||||0.376|TWO_SIDED|95.0|-1.03|2.724|||analysis of covariance|adjusted for baseline score using mixed-model||||2.724|-1.030|0.376
74018140|NCT01235962|147587748|SUPERIORITY||Mean Difference (48M DFS FU - thermo)|0.131||||0.905|TWO_SIDED|95.0|-2.032|2.294|||analysis of covariance|adjusted for baseline score using mixed-model||||2.294|-2.032|0.905
74018141|NCT01235962|147587748|SUPERIORITY||Mean Difference (54M DFS FU - thermo)|0.401||||0.768|TWO_SIDED|95.0|-2.269|3.071|||analysis of covariance|adjusted for baseline score using mixed-model||||3.071|-2.269|0.768
74018142|NCT01235962|147587748|SUPERIORITY||Mean Difference (Week 52 - UI)|-0.026||||0.007|TWO_SIDED|95.0|-0.044|-0.007|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.007|-0.044|0.007
74018143|NCT01235962|147587748|SUPERIORITY||Mean Difference (24M DFS FU - UI)|-0.016||||0.13|TWO_SIDED|95.0|-0.036|0.005|||analysis of covariance|adjusted for baseline score using mixed-model||||0.005|-0.036|0.130
74018144|NCT01235962|147587748|SUPERIORITY||Mean Difference (36M DFS FU - UI)|0.007||||0.52|TWO_SIDED|95.0|-0.015|0.03|||analysis of covariance|adjusted for baseline score using mixed-model||||0.030|-0.015|0.520
74018145|NCT01235962|147587748|SUPERIORITY||Mean Difference (48M DFS FU - UI)|-0.014||||0.276|TWO_SIDED|95.0|-0.04|0.011|||analysis of covariance|adjusted for baseline score using mixed-model||||0.011|-0.040|0.276
74018146|NCT01235962|147587748|SUPERIORITY||Mean Difference (54M DFS FU - UI)|-0.007||||0.665|TWO_SIDED|95.0|-0.037|0.024|||analysis of covariance|adjusted for baseline score using mixed-model||||0.024|-0.037|0.665
74018147|NCT01405053|147587784|SUPERIORITY||LS Mean difference|2.601|STANDARD_ERROR_OF_MEAN|6.558||0.6928|TWO_SIDED|95.0|-10.5|15.7|||ANCOVA|||The primary statistical model for comparing the 2 treatment groups was an analysis of covariance (ANCOVA) mixed model for repeated measures with baseline score, age, and sex as covariates, and treatment, week, and treatment by week interaction as factors.||15.7|-10.5|0.6928
74046690|NCT02725268|147645586|SUPERIORITY||Hazard Ratio (HR)|1.5|||=|0.145|TWO_SIDED|95.0|0.95|2.37||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.37|0.95|=0.145
74046691|NCT02725268|147645586|SUPERIORITY||Hazard Ratio (HR)|1.54|||=|0.243|TWO_SIDED|95.0|0.87|2.73||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.73|0.87|=0.243
74046692|NCT02725268|147645587|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.17|TWO_SIDED|95.0|0.57|1.11||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.11|0.57|=0.170
74046693|NCT02725268|147645587|SUPERIORITY||Hazard Ratio (HR)|1.67|||=|0.224|TWO_SIDED|95.0|1.04|2.68||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.68|1.04|=0.224
74046694|NCT02725268|147645587|SUPERIORITY||Hazard Ratio (HR)|2.28|||=|0.244|TWO_SIDED|95.0|1.32|3.96||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||3.96|1.32|=0.244
74046695|NCT02725268|147645588|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.66|2.9|||||The odds ratio and 95% confidence intervals were obtained using a stratified Cochran-Mantel-Haenszel (CMH) model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||2.90|0.66|
74046696|NCT02725268|147645588|SUPERIORITY||Odds Ratio (OR)|0.22|||||TWO_SIDED|95.0|0.04|1.14|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||1.14|0.04|
74046697|NCT02725268|147645588|SUPERIORITY||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.00|0.00|
74046698|NCT02725268|147645589|SUPERIORITY||Odds Ratio (OR)|3.02|||||TWO_SIDED|95.0|1.53|5.96|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||5.96|1.53|
74046699|NCT02725268|147645589|SUPERIORITY||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.18|0.86|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.86|0.18|
74046700|NCT02725268|147645589|SUPERIORITY||Odds Ratio (OR)|0.43|||||TWO_SIDED|95.0|0.15|1.21|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||1.21|0.15|
74046701|NCT02725268|147645590|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|0.89|7.67|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||7.67|0.89|
74046702|NCT02725268|147645590|SUPERIORITY||Odds Ratio (OR)|0.15|||||TWO_SIDED|95.0|0.05|0.51|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.51|0.05|
74046703|NCT02725268|147645590|SUPERIORITY||Odds Ratio (OR)|0.07|||||TWO_SIDED|95.0|0.01|0.67|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.67|0.01|
74046704|NCT04498468|147645591|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.003|TWO_SIDED|95.0|-0.91|-0.19|||t-test, 2 sided|||Corneal staining analysis, day 28.||-0.19|-0.91|0.003
74046705|NCT04498468|147645591|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.19|TWO_SIDED|95.0|-1.28|0.28|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, 18-59 year old subgroup.||0.28|-1.28|0.19
74046706|NCT04498468|147645591|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.047|TWO_SIDED|95.0|-1.86|-0.02|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, 60+ year old subgroup.||-0.02|-1.86|0.047
74046707|NCT04498468|147645591|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.08|TWO_SIDED|95.0|-1.49|0.1|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, Sjogren's subgroup.||0.10|-1.49|0.08
74046708|NCT04498468|147645591|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.09|TWO_SIDED|95.0|-1.67|0.14|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, non-Sjogren's subgroup.||0.14|-1.67|0.09
74046709|NCT04498468|147645591|SUPERIORITY||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-1.05|-0.3|||t-test, 2 sided|||Conjunctival staining analysis, day 28||-0.30|-1.05|< 0.001
74046710|NCT04498468|147645591|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.58|TWO_SIDED|95.0|-1.04|0.61|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, 18-59 year old subgroup.||0.61|-1.04|0.58
74096705|NCT06354998|147742573|OTHER||Geometric Mean Ratio (GMR)|0.908|||||TWO_SIDED|95.0|0.662|1.245|||||GMR was a secondary endpoint.|GMR (mRNA-1273.815 versus licensed Spikevax) at Day 15 and its 95% CI was calculated based on the t-distribution for the mean difference of log-transformed antibody values and then back transformed to the original scale for presentation.||1.245|0.662|
74046711|NCT04498468|147645591|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.021|TWO_SIDED|95.0|-2.17|-0.21|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, 60+ year old subgroup.||-0.21|-2.17|0.021
74046712|NCT04498468|147645591|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.16|TWO_SIDED|95.0|-1.88|0.34|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, Sjogren's subgroup.||0.34|-1.88|0.16
74046713|NCT04498468|147645591|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.097|TWO_SIDED|95.0|-1.55|0.14|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, non-Sjogren's subgroup.||0.14|-1.55|0.097
74046714|NCT04498468|147645592|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.069|TWO_SIDED|95.0|-11.4|0.4|||t-test, 2 sided|||Eye dryness, day 28||0.4|-11.4|0.069
74046715|NCT04498468|147645592|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.92|TWO_SIDED|95.0|-7.0|6.3|||t-test, 2 sided|||VAS Eye discomfort, Day 28||6.3|-7.0|0.92
74046716|NCT04498468|147645592|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.55|TWO_SIDED|95.0|-5.8|3.1|||t-test, 2 sided|||VAS eye fatigue, day 28||3.1|-5.8|0.55
74046717|NCT04498468|147645593|SUPERIORITY||Risk Ratio (RR)|1.26||||0.42|TWO_SIDED|95.0|0.8|2.0|||McNemar|||||2.0|0.8|0.42
74046718|NCT04498468|147645594|SUPERIORITY||Risk Ratio (RR)|1.04||||1|TWO_SIDED|95.0|0.76|1.42|||McNemar|||||1.42|0.76|1.00
74046719|NCT04973085|147645607|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
74046720|NCT01627782|147645639|SUPERIORITY_OR_OTHER_LEGACY||Difference of Least Square Means|-16.0|||<|0.001|TWO_SIDED|70.0|-20.0|-12.01|||Mixed Effect Model Repeated Measure|||||-12.01|-20.00|< 0.001
74046721|NCT01627782|147645639|SUPERIORITY_OR_OTHER_LEGACY||Difference of Least Square Means|-16.4|||<|0.001|TWO_SIDED|70.0|-18.96|-13.84|||Mixed Effect Model Repeated Measure|||||-13.84|-18.96|< 0.001
74046722|NCT00089999|147645697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.691|TWO_SIDED|95.0|0.3|1.9|||Fisher Exact|||||1.9|0.3|0.691
74046723|NCT00089999|147645698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.443|TWO_SIDED|95.0|0.3|1.6|||Fisher Exact||Overall Response (i.e. sum of Complete and Partial Responses) comparison|||1.6|0.3|0.443
74096706|NCT02800213|147742576|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.280
74046724|NCT01193049|147645713|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.25||||0.001|TWO_SIDED|90.0|0.14|0.46||1-sided p-value, α = 0.05|ANOVA|||GM Fold Reduction (FR) is the GM of individual FC(Prednisone)/FC (Placebo) from SP.||0.46|0.14|0.001
74046725|NCT01193049|147645713|SUPERIORITY_OR_OTHER||GM FR from Placebo : NE|0.2|||<|0.001|TWO_SIDED|90.0|0.13|0.3||1-sided p value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC(Placebo) from NE.||0.30|0.13|<0.001
74096707|NCT02994940|147742580|SUPERIORITY||Hodges Lehman estimator|21.3||||0.127|TWO_SIDED|95.0|-2.5|44.2|||Wilcoxon (Mann-Whitney)|||||44.2|-2.5|0.127
74096708|NCT02994940|147742581|SUPERIORITY|||||||0.851|||||||Chi-squared|||||||0.851
74046726|NCT01193049|147645713|SUPERIORITY_OR_OTHER||Correlation FC from BL: SP vs NE|0.2||||0.553||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-5 after placebo treatment.||||0.553
74096709|NCT02994940|147742582|SUPERIORITY||Hodges Lehman estimator|2.0||||0.109|TWO_SIDED|95.0|-1.0|6.0|||Wilcoxon (Mann-Whitney)|||||6.0|-1.0|0.109
74096710|NCT02994940|147742583|SUPERIORITY||Hodges Lehman estimator|7.0||||0.0001|TWO_SIDED|95.0|4.0|8.0|||Wilcoxon (Mann-Whitney)|||||8.0|4.0|0.0001
74096711|NCT03233230|147742584|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1746|TWO_SIDED|95.0|0.84|2.61|||Regression, Logistic|||||2.61|0.84|0.1746
74096712|NCT03233230|147742584|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8283|TWO_SIDED|95.0|0.61|1.87|||Regression, Logistic|||||1.87|0.61|0.8283
74046727|NCT01193049|147645713|SUPERIORITY_OR_OTHER||Correlation FR from Placebo :SP vs NE|-0.02||||0.964||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-5 after prednisone treatment.||||0.964
74046728|NCT01193049|147645714|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.27||||0.009|TWO_SIDED|90.0|0.12|0.62||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC (Placebo) from SP.||0.62|0.12|0.009
74046729|NCT01193049|147645714|SUPERIORITY_OR_OTHER||GM FR from Placebo : NE|0.31|||<|0.001|TWO_SIDED|90.0|0.22|0.43||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC Prednisone)/FC(Placebo) from NE.||0.43|0.22|<0.001
74046730|NCT01193049|147645714|SUPERIORITY_OR_OTHER||Correlation FC from BL: SP vs NE|-0.02||||0.962||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-13 after placebo treatment.||||0.962
74046731|NCT01193049|147645714|SUPERIORITY_OR_OTHER||Correlation FR from Placebo: SP vs NE|0.07||||0.83||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-13 after prednisone treatment.||||0.83
74046732|NCT01193049|147645715|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.8||||0.258|TWO_SIDED|90.0|0.43|1.47||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.||1.47|0.43|0.258
74046733|NCT01193049|147645715|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|1.08||||0.681|TWO_SIDED|90.0|0.8|1.46||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.||1.46|0.80|0.681
74046734|NCT01193049|147645716|SUPERIORITY_OR_OTHER||GM FR from Placebo:SP|0.61||||0.117|TWO_SIDED|90.0|0.3|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.||1.24|0.30|0.117
74046735|NCT01193049|147645716|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.64||||0.011|TWO_SIDED|90.0|0.47|0.86||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.||0.86|0.47|0.011
74046736|NCT01193049|147645718|SUPERIORITY_OR_OTHER||GM FR from Placebo: IL-5|1.51||||0.01|TWO_SIDED|90.0|1.15|1.99||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) for IL-5.||1.99|1.15|0.010
74096713|NCT03233230|147742584|SUPERIORITY||Odds Ratio (OR)|1.55||||0.1298|TWO_SIDED|95.0|0.88|2.74|||Regression, Logistic|||||2.74|0.88|0.1298
74096714|NCT03233230|147742585|SUPERIORITY||Response rate difference|0.13||||0.0077|TWO_SIDED|95.0|0.04|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.04|0.0077
74096715|NCT03233230|147742585|SUPERIORITY||Response rate difference|0.17||||0.0013|TWO_SIDED|95.0|0.07|0.27|||Cochran-Mantel-Haenszel|||||0.27|0.07|0.0013
74096716|NCT03233230|147742585|SUPERIORITY||Response rate difference|0.13||||0.008|TWO_SIDED|95.0|0.04|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.04|0.0080
73888081|NCT01746901|147309534|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.5592|TWO_SIDED|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-3.0|0.5592
74046737|NCT01193049|147645718|SUPERIORITY_OR_OTHER||GM FR from Placebo: IL-13|1.35||||0.02|TWO_SIDED|90.0|1.07|1.71||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) for IL-13.||1.71|1.07|0.020
74046738|NCT01193049|147645719|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.82||||0.119|TWO_SIDED|90.0|0.62|1.09||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from SP.||1.09|0.62|0.119
74046739|NCT01193049|147645719|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.68||||0.103|TWO_SIDED|90.0|0.41|1.14||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from NE.||1.14|0.41|0.103
74046740|NCT01193049|147645720|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.6||||0.003|TWO_SIDED|90.0|0.46|0.77||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-1β from SP.||0.77|0.46|0.003
74046741|NCT01193049|147645720|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.49||||0.036|TWO_SIDED|90.0|0.26|0.93||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in IL-1β from NE.||0.93|0.26|0.036
74046742|NCT01193049|147645721|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.7||||0.143|TWO_SIDED|90.0|0.4|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in MIP-1β from SP.||1.24|0.40|0.143
74046743|NCT01193049|147645721|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.61||||0.056|TWO_SIDED|90.0|0.37|1.02||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in MIP-1β from NE.||1.02|0.37|0.056
74046744|NCT04283773|147645728|SUPERIORITY||Median Difference (Final Values)|0.001|STANDARD_DEVIATION|1.5||0.001|TWO_SIDED|95.0|0.0|8.0||The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.|Kruskal-Wallis|||Assessment of statistical differences in P16 expression between 3 groups. The immunohistochemical evaluation is done using German- semiquantitative scoring system. The score ranges from ( 0, 1,2,3,4,6,8,9 and 12). The data will entered on SPSS,version 24 as numbers. The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.||8|0|0.001
74046745|NCT04283773|147645729|SUPERIORITY||Hazard Ratio, log|0.009||||0.009|TWO_SIDED|95.0|0.0|8.0||Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.|Spearman's rank correlation coefficient(|||Correlation between Ki 67 expression using percentage of Ki67 positive nuclei and P16 cytoplasmic expression using German semi quantitative score among MOGCT group. Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.||8|0|0.009
74046746|NCT04283773|147645730|SUPERIORITY|One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.|Mean Difference (Final Values)|11.0|STANDARD_DEVIATION|1.5||0.699|TWO_SIDED|80.0|9.5|13.0||One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.|ANOVA|||Correlation between P16 cytoplasmic score using German semi-quantitative system and FIGO staging of MOGCTs was done via One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD).||13|9.5|0.699
74046747|NCT06048809|147645733|OTHER|||||||2.36e-05|||||||ANCOM-BC2|||Haemophilus parainfluenzae: Change From Baseline at Week 6||||0.0000236
74046748|NCT06048809|147645733|OTHER|||||||0.0033243|||||||ANCOM-BC2|||Neisseria elongata: Change From Baseline at Week 6||||0.0033243
74046749|NCT06048809|147645733|OTHER|||||||0.00500088|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_898: Change From Baseline at Week 6||||0.00500088
74046750|NCT06048809|147645733|OTHER|||||||0.0066975|||||||ANCOM-BC2|||Parvimonas sp.\_HMT\_110: Change From Baseline at Week 6||||0.0066975
74046751|NCT06048809|147645733|OTHER|||||||0.00710228|||||||ANCOM-BC2|||Aggregatibacter aphrophilus: Change From Baseline at Week 6||||0.00710228
74046752|NCT06048809|147645733|OTHER|||||||0.00744022|||||||ANCOM-BC2|||Kingella oralis: Change From Baseline at Week 6||||0.00744022
74046753|NCT06048809|147645733|OTHER|||||||0.01434037|||||||ANCOM-BC2|||Haemophilus sp.\_HMT\_036: Change From Baseline at Week 6||||0.01434037
74046754|NCT06048809|147645733|OTHER|||||||0.01955327|||||||ANCOM-BC2|||Haemophilus haemolyticus: Change From Baseline at Week 6||||0.01955327
74046755|NCT06048809|147645733|OTHER|||||||0.01995277|||||||ANCOM-BC2|||Neisseria mucosa: Change From Baseline at Week 6||||0.01995277
74046756|NCT06048809|147645733|OTHER|||||||0.02082528|||||||ANCOM-BC2|||Parvimonas sp.\_HMT\_393\_nov\_97.053%: Change From Baseline at Week 6||||0.02082528
74046757|NCT06048809|147645733|OTHER|||||||0.02188156|||||||ANCOM-BC2|||Ottowia sp.\_HMT\_894: Change from Baseline at Week 6||||0.02188156
74046758|NCT06048809|147645733|OTHER|||||||0.02321733|||||||ANCOM-BC2|||Cryptobacterium curtum: Change From Baseline at Week 6||||0.02321733
74046759|NCT06048809|147645733|OTHER|||||||0.02397996|||||||ANCOM-BC2|||Lautropia mirabilis: Change from Baseline at Week 6||||0.02397996
74046760|NCT06048809|147645733|OTHER|||||||0.02509094|||||||ANCOM-BC2|||Haemophilus paraphrohaemolyticus: Change From Baseline at Week 6||||0.02509094
74046761|NCT06048809|147645733|OTHER|||||||0.02648847|||||||ANCOM-BC2|||Capnocytophaga sp.\_HMT\_332: Change From Baseline at Week 6||||0.02648847
74046762|NCT06048809|147645733|OTHER|||||||0.02828764|||||||ANCOM-BC2|||Neisseria flavescens: Change From Baseline at Week 6||||0.02828764
74046763|NCT06048809|147645733|OTHER|||||||0.03454372|||||||ANCOM-BC2|||Capnocytophaga gingivalis\_nov\_96.429%: Change From Baseline at Week 6||||0.03454372
74046764|NCT06048809|147645733|OTHER|||||||0.03747507|||||||ANCOM-BC2|||Capnocytophaga sputigena: Change From Baseline at Week 6||||0.03747507
74046765|NCT06048809|147645733|OTHER|||||||0.03776136|||||||ANCOM-BC2|||Haemophilus sputorum: Change From Baseline at Week 6||||0.03776136
74046766|NCT06048809|147645733|OTHER|||||||0.03853215|||||||ANCOM-BC2|||Capnocytophaga gingivalis\_nov\_90.546%: Change From Baseline at Week 6||||0.03853215
74018148|NCT02175680|147587806|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Rank Sum|The time to Virologic Failure for the subjects treated with PRO 140 monotherapy was compared to historical data.|||The median time to Virologic Failure for historical controls was 29 days.|||<0.0001
74018149|NCT01913483|147587837|SUPERIORITY|||||||0.9458||||||The primary endpoint analysis was to assess the superiority of bivalirudin versus UFH in BARC ≥3 bleeds within the 48 hours post study drug initiation or at hospital discharge, whichever occurred first.|Chi-squared|||Assuming a bleeding event rate of 5.0% in the heparin control treatment group and 3.2% in the bivalirudin group (36% relative risk reduction, a sample size of 3900 participants was to provide more than 80% power with a two-tailed alpha level of 0.05). This estimate took into consideration that the interim efficacy analysis was to be performed when approximately 70% of participants were enrolled using the O'Brien-Fleming alpha spending function.||||0.9458
74018150|NCT02302963|147587840|OTHER|Analysis of Variance|||||<|0.001|||||||GLM Repeated Measures|Repeated-measures general linear model was used to compare HCLC versus SAP data. A P-value of \< 0.001 was considered the threshold for significance.||||||<0.001
74018151|NCT00915343|147587845|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.806|||<|0.0001|TWO_SIDED|95.0|0.753|0.862||Comparison of log S-cortisol AUC between OD and TID regimens was adjusted for both period effect and subject effect using generalized linear model (GLM) in statistical analysis system (SAS).|ANOVA||The quotient was defined as AUC0-24h for OD treatment divided by AUC0-24h for TID treatment.|||0.862|0.753|<0.0001
74018152|NCT00915343|147587846|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-111.989|||<|0.0001|TWO_SIDED|95.0|-133.98|89.999|||Fisher's non-parametric permutation test|||||89.999|-133.980|<0.0001
74018153|NCT00915343|147587847|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|110.417||||0.0357|TWO_SIDED|95.0|16.755|204.078|||Fisher's non-parametric permutation test|||||204.078|16.755|0.0357
74018154|NCT00915343|147587848|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-38.076|||<|0.0001|TWO_SIDED|95.0|-50.276|25.876|||Fisher's non-parametric permutation test|||||25.876|-50.276|<0.0001
74018155|NCT00915343|147587849|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-65.782||||0.0033|TWO_SIDED|95.0|-109.201|22.362|||Fisher's non-parametric permutation test|||||22.362|-109.201|0.0033
74018156|NCT00915343|147587850|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-148.015|||<|0.0001|TWO_SIDED|95.0|-189.469|-106.561|||Fisher's non-parametric permutation test|||||-106.561|-189.469|<0.0001
74018157|NCT00915343|147587851|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-108.306|||<|0.0001|TWO_SIDED|95.0|-140.193|-76.42|||Fisher's non-parametric permutation test|||||-76.420|-140.193|<0.0001
74018158|NCT00915343|147587852|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.27||||0.0214|TWO_SIDED|95.0|0.028|0.512|||Fisher's non-parametric permutation test|||||0.512|0.028|0.0214
74018159|NCT00915343|147587853|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-1.042||||0.0714|TWO_SIDED|95.0|-2.098|0.015|||Fisher's non-parametric permutation test|||||0.015|-2.098|0.0714
74018160|NCT00915343|147587854|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.007||||0.6687|TWO_SIDED|95.0|-0.038|0.024|||Fisher's non-parametric permutation test|||||0.024|-0.038|0.6687
74018161|NCT00915343|147587855|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.049||||0.028|TWO_SIDED|95.0|0.006|0.093|||Fisher's non-parametric permutation test|||||0.093|0.006|0.0280
74018162|NCT00915343|147587856|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|5.509||||0.0003|TWO_SIDED|95.0|0.751|10.268|||Fisher's non-parametric permutation test|||||10.268|0.751|0.0003
74018163|NCT00915343|147587857|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-13.8|||<|0.0001|TWO_SIDED|95.0|-20.533|-7.067|||Fisher's non-parametric permutation test|||||-7.067|-20.533|<0.0001
74018164|NCT00915343|147587858|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.064||||0.0002|TWO_SIDED|95.0|1.032|1.097|||ANOVA||The quotient was defined as AUC0-4h for OD treatment divided by AUC0-4h for TID treatment.|AUC0-4h||1.097|1.032|0.0002
74018165|NCT00915343|147587858|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.617|||<|0.0001|TWO_SIDED|95.0|0.563|0.675|||ANOVA||The quotient was defined as AUC4-12h for OD treatment divided by AUC4-12h for TID treatment.|AUC4-12h||0.675|0.563|<0.0001
74018166|NCT00915343|147587858|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.472|||<|0.0001|TWO_SIDED|95.0|0.424|0.525|||ANOVA||The quotient was defined as AUC6-12h for OD treatment divided by AUC6-12h for TID treatment.|AUC6-12h||0.525|0.424|<0.0001
74018167|NCT00915343|147587858|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.588||||0.0003|TWO_SIDED|95.0|0.446|0.775|||ANOVA||The quotient was defined as AUC12-24h for OD treatment divided by AUC12-24h for TID treatment.|AUC12-24h||0.775|0.446|0.0003
74018168|NCT00915343|147587858|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.894|||<|0.0001|TWO_SIDED|95.0|0.856|0.935|||ANOVA||The quotient was defined as AUC0-10h for OD treatment divided by AUC0-10h for TID treatment.|AUC0-10h||0.935|0.856|<0.0001
74018169|NCT00915343|147587858|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.695|||<|0.0001|TWO_SIDED|95.0|0.632|0.765|||ANOVA||The quotient was defined as AUC4-10h for OD treatment divided by AUC4-10h for TID treatment.|AUC4-10h||0.765|0.632|<0.0001
74018170|NCT00915343|147587858|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.54|||<|0.0001|TWO_SIDED|95.0|0.482|0.605|||ANOVA||The quotient was defined as AUC6-10h for OD treatment divided by AUC6-10h for TID treatment.|AUC6-10h||0.605|0.482|<0.0001
74046767|NCT06048809|147645733|OTHER|||||||0.04751303|||||||ANCOM-BC2|||Prevotella denticola: Change From Baseline at Week 6||||0.04751303
74046768|NCT06048809|147645733|OTHER|||||||0.05190512|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_513: Change From Baseline at Week 6||||0.05190512
74046769|NCT06048809|147645733|OTHER|||||||0.0550647|||||||ANCOM-BC2|||Veillonella sp.\_HMT\_780: Change From Baseline at Week 6||||0.0550647
74046770|NCT06048809|147645733|OTHER|||||||0.05861488|||||||ANCOM-BC2|||Neisseria perflava: Change From Baseline at Week 6||||0.05861488
74046771|NCT06048809|147645733|OTHER|||||||0.06727926|||||||ANCOM-BC2|||Slackia exigua: Change From Baseline at Week 6||||0.06727926
74046772|NCT06048809|147645733|OTHER|||||||0.07051698|||||||ANCOM-BC2|||Shuttleworthia satelles: Change from Baseline at Week 6||||0.07051698
74046773|NCT06048809|147645733|OTHER|||||||0.0740793|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_458: Change From Baseline at Week 6||||0.0740793
74046774|NCT06048809|147645733|OTHER|||||||0.07426973|||||||ANCOM-BC2|||Ruminococcaceae\_\[G-1\] bacterium\_HMT\_075: Change From Baseline at Week 6||||0.07426973
74046775|NCT06048809|147645733|OTHER|||||||0.07829888|||||||ANCOM-BC2|||Campylobacter showae: Change From Baseline at Week 6||||0.07829888
74046776|NCT06048809|147645733|OTHER|||||||0.08462924|||||||ANCOM-BC2|||Streptococcus sp.\_HMT\_056: Change From Baseline at Week 6||||0.08462924
74046777|NCT06048809|147645734|OTHER|||||||0.062378|||||||ANCOM-BC2|||Abiotrophia defectiva: Change from Baseline at Week 6||||0.062378
73880718|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|5.5||||0.13|TWO_SIDED|95.0|0.61|50.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||50.06|0.61|0.1300
73880719|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.81||||0.4152|TWO_SIDED|95.0|0.43|7.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.53|0.43|0.4152
73880720|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9645|TWO_SIDED|95.0|0.27|3.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.50|0.27|0.9645
73880721|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3884|TWO_SIDED|95.0|0.43|8.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.96|0.43|0.3884
74046778|NCT06048809|147645734|OTHER|||||||0.063437|||||||ANCOM-BC2|||Saccharibacteria\_(TM7)\_\[G1\] bacterium\_HMT\_346: Change from Baseline at Week 6||||0.063437
73880722|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.62||||0.267|TWO_SIDED|95.0|0.48|14.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.41|0.48|0.2670
73880723|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|6.91||||0.0861|TWO_SIDED|95.0|0.76|62.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||62.90|0.76|0.0861
73880724|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|7.21||||0.0774|TWO_SIDED|95.0|0.8|64.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||64.66|0.80|0.0774
74018171|NCT00915343|147587858|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.412|||<|0.0001|TWO_SIDED|95.0|0.338|0.504|||ANOVA||The quotient was defined as AUC10-24h for OD treatment divided by AUC10-24h for TID treatment.|AUC10-24h||0.504|0.338|<0.0001
74018172|NCT00915343|147587858|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.776|||<|0.0001|TWO_SIDED|95.0|0.714|0.843|||ANOVA||The quotient was defined as AUC(0-inf) for OD treatment divided by AUC(0-inf) for TID treatment.|AUC(0-inf)||0.843|0.714|<0.0001
74018173|NCT00915343|147587858|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.069||||0.877|TWO_SIDED|95.0|0.453|2.521|||ANOVA||The quotient was defined as AUC(24h-inf) for OD treatment divided by AUC(24h-inf) for TID treatment.|AUC(24h-inf)||2.521|0.453|0.8770
74018174|NCT00915343|147587859|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.806|||<|0.0001|TWO_SIDED|95.0|0.753|0.862|||ANOVA||The quotient was defined as AUCtau for OD treatment divided by AUCtau for TID treatment.|||0.862|0.753|<0.0001
74018175|NCT00915343|147587860|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.79|||<|0.0001|TWO_SIDED|95.0|0.734|0.851|||ANOVA||The quotient was defined as AUCtau/dose for OD treatment divided by AUCtau/dose for TID treatment.|||0.851|0.734|<0.0001
74018176|NCT00915343|147587861|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.785|||<|0.0001|TWO_SIDED|95.0|0.741|0.831|||ANOVA||The quotient was defined as AUC0-24h/dose for OD treatment divided by AUC0-24h/dose for TID treatment.|||0.831|0.741|<0.0001
74018177|NCT00915343|147587862|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.885|||<|0.0001|TWO_SIDED|95.0|0.844|0.926|||ANOVA||The quotient was defined as AUC0-10h/dose for OD treatment divided by AUC0-10h/dose for TID treatment.|||0.926|0.844|<0.0001
74018178|NCT00915343|147587863|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.053||||0.002|TWO_SIDED|95.0|1.02|1.086|||ANOVA||The quotient was defined as AUC0-4h/dose for OD treatment divided by AUC0-4h/dose for TID treatment.|||1.086|1.020|0.0020
74018179|NCT00915343|147587864|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001|||<|0.0001|TWO_SIDED|95.0|-0.001|0.0|||Fisher's non-parametric permutation test|||||-0.000|-0.001|<0.0001
74018180|NCT00915343|147587865|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001|||<|0.0001|TWO_SIDED|95.0|-0.002|-0.001|||Fisher's non-parametric permutation test|||||-0.001|-0.002|<0.0001
74018181|NCT00915343|147587866|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.055||||0.7827|TWO_SIDED|95.0|-0.444|0.334|||Fisher's non-parametric permutation test|||||0.334|-0.444|0.7827
74018182|NCT00915343|147587867|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001||||0.0015|TWO_SIDED|95.0|-0.001|0.0|||Fisher's non-parametric permutation test|||||-0.000|-0.001|0.0015
74018183|NCT00915343|147587868|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|6.098|||<|0.0001|TWO_SIDED|95.0|2.94|12.646|||ANOVA||The quotient was defined as AUC Extrapolation for OD treatment divided by AUC Extrapolation for TID treatment.|||12.646|2.940|<0.0001
74018184|NCT00915343|147587869|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|33.532||||0.0396|TWO_SIDED|95.0|1.734|65.329|||Fisher's non-parametric permutation test|||||65.329|1.734|0.0396
74018185|NCT00915343|147587870|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.08||||0.1032|TWO_SIDED|95.0|-0.017|0.177|||Fisher's non-parametric permutation test|||||0.177|-0.017|0.1032
74018186|NCT00915343|147587871|SUPERIORITY_OR_OTHER_LEGACY||least square mean|-0.078||||0.3767|TWO_SIDED|95.0|-0.25|0.094|||Fisher's test|Fisher's non||Patient||0.094|-0.250|0.3767
74018187|NCT00915343|147587871|SUPERIORITY_OR_OTHER_LEGACY||least square mean|-0.064||||0.4625|TWO_SIDED|95.0|-0.235|0.107|||Fisher's test|Fisher's non||Investigator||0.107|-0.235|0.4625
74018188|NCT00915343|147587872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6072|TWO_SIDED||||||Sign test|||Patient||||0.6072
74018189|NCT00915343|147587872|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Sign test|||Investigator||||1.0000
74018190|NCT00915343|147587873|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.6||||0.3332|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score||||0.3332
73880725|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|4.73||||0.0389|TWO_SIDED|95.0|1.08|20.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||20.65|1.08|0.0389
73880726|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.81||||0.3695|TWO_SIDED|95.0|0.5|6.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.57|0.50|0.3695
73880727|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3501|TWO_SIDED|95.0|0.48|7.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.89|0.48|0.3501
73880728|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.49||||0.2021|TWO_SIDED|95.0|0.61|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.14|0.61|0.2021
73880729|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.42||||0.6201|TWO_SIDED|95.0|0.36|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.62|0.36|0.6201
74046779|NCT06048809|147645734|OTHER|||||||0.069908|||||||ANCOM-BC2|||Olsenella sp.\_HMT\_807: Change from Baseline at Week 6||||0.069908
74046780|NCT06048809|147645734|OTHER|||||||0.079736|||||||ANCOM-BC2|||Fusobacterium nucleatum\_nucleatum\_subsp.\_animalis: Change from Baseline at Week 6||||0.079736
74046781|NCT06048809|147645734|OTHER|||||||0.094642|||||||ANCOM-BC2|||Bergeyella sp.\_HMT\_322: Change from Baseline at Week 6||||0.094642
74046782|NCT06048809|147645734|OTHER|||||||0.095848|||||||ANCOM-BC2|||Peptostreptococcaceae\_\[XI\]\[G-1\] \[Eubacterium\]\_infirmum: Change from Baseline at Week 6||||0.095848
74046783|NCT06048809|147645734|OTHER|||||||0.107931|||||||ANCOM-BC2|||Prevotella sp.\_HMT\_317: Change from Baseline at Week 6||||0.107931
74046784|NCT06048809|147645734|OTHER|||||||0.109114|||||||ANCOM-BC2|||Bacteroidales\_\[G-2\] bacterium\_HMT\_274: Change from Baseline at Week 6||||0.109114
74046785|NCT06048809|147645734|OTHER|||||||0.11083|||||||ANCOM-BC2|||Actinomyces sp.\_HMT\_175\_nov 97.951%: Change from Baseline at Week 6||||0.11083
74046786|NCT06048809|147645734|OTHER|||||||0.120377|||||||ANCOM-BC2|||Slackia exigua: Change from Baseline at Week 6||||0.120377
74046787|NCT06048809|147645734|OTHER|||||||0.123758|||||||ANCOM-BC2|||Granulicatella adiacens: Change from Baseline at Week 6||||0.123758
74046788|NCT06048809|147645734|OTHER|||||||0.123992|||||||ANCOM-BC2|||Prevotella oris: Change from Baseline at Week 6||||0.123992
74046789|NCT06048809|147645734|OTHER|||||||0.133385|||||||ANCOM-BC2|||Streptococcus sp.\_HMT\_064: Change from Baseline at Week 6||||0.133385
74046790|NCT06048809|147645734|OTHER|||||||0.144598|||||||ANCOM-BC2|||Schaalia odontolyticus: Change from Baseline at Week 6||||0.144598
74096717|NCT03233230|147742586|SUPERIORITY||Response rate difference|0.09||||0.0056|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0056
73880730|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|13.71||||0.0235|TWO_SIDED|95.0|1.42|132.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||132.0|1.42|0.0235
74046791|NCT06048809|147645734|OTHER|||||||0.147278|||||||ANCOM-BC2|||Mogibacterium diversum: Change from Baseline at Week 6||||0.147278
74046792|NCT06048809|147645734|OTHER|||||||0.148674|||||||ANCOM-BC2|||Prevotella denticola: Change from Baseline at Week 6||||0.148674
74046793|NCT06048809|147645734|OTHER|||||||0.149722|||||||ANCOM-BC2|||Absconditabacteria\_(SR1)\_\[G-1\] bacterium\_HMT\_875: Change from Baseline at Week 6||||0.149722
74046794|NCT06048809|147645734|OTHER|||||||0.154465|||||||ANCOM-BC2|||Prevotella nigrescens: Change from Baseline at Week 6||||0.154465
74046795|NCT06048809|147645734|OTHER|||||||0.158139|||||||ANCOM-BC2|||Streptococcus chosunense: Change from Baseline at Week 6||||0.158139
74046796|NCT03887052|147645739|NON_INFERIORITY|The primary endpoint was performed as a one-sided test with a 0.025 significance level of the null hypothesis (H0) that the WCD false positive shock alarm rate per patient-day for the study device was equal to or greater than the comparator rate (0.29). A random-effects Poisson regression model was fit with the number of false-positive shock alarms for each patient as the outcome, the logarithm of days of wear as an offset, and random site effect.|||||<|0.001||||||"Hypotheses:~H0: p1 ≥ 0.29 H1: p1 \< 0.29~where p1 = A-WCD False Positive Alarm Rate"|One-sided non-inferiority|Poisson Regression Analysis||The analysis was based on the cohort of 130 patients with three false-positive shock alarms occurring over a total of 3501 patient-days (500 weeks), or 0.0060 false-positive shock alarms per patient-week. The Poisson distribution was used to model the results and calculate the false-positive shock alarm rate.||||<0.001
74046797|NCT01804842|147645742|SUPERIORITY_OR_OTHER||% Ratio of LS Means|71.7||||0.0018|TWO_SIDED|90.0|61.14|84.01|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.||84.01|61.14|0.0018
74046798|NCT01804842|147645742|SUPERIORITY_OR_OTHER||% Ratio of LS Means|71.5||||0.002|TWO_SIDED|90.0|60.85|84.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||84.09|60.85|0.0020
74046799|NCT01804842|147645742|SUPERIORITY_OR_OTHER||% Ratio of LS Means|99.8||||0.9844|TWO_SIDED|90.0|84.91|117.33|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||117.33|84.91|0.9844
74096718|NCT03233230|147742586|SUPERIORITY||Response rate difference|0.09||||0.005|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0050
74096719|NCT03233230|147742586|SUPERIORITY||Response rate difference|0.09||||0.0053|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0053
73880731|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.43||||0.0929|TWO_SIDED|95.0|0.81|14.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||14.48|0.81|0.0929
73880732|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|0.99||||0.982|TWO_SIDED|95.0|0.29|3.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.33|0.29|0.9820
73880733|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.55||||0.4956|TWO_SIDED|95.0|0.44|5.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.41|0.44|0.4956
73880734|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5708|TWO_SIDED|95.0|0.2|2.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.44|0.20|0.5708
73880735|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1985|TWO_SIDED|95.0|0.61|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||10.61|0.61|0.1985
73880736|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8368|TWO_SIDED|95.0|0.31|4.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.32|0.31|0.8368
73880737|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|3.18||||0.1397|TWO_SIDED|95.0|0.68|14.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||14.76|0.68|0.1397
74096720|NCT03233230|147742587|SUPERIORITY||Response rate difference|0.09||||0.1419|TWO_SIDED|95.0|-0.03|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.03|0.1419
74096721|NCT03233230|147742587|SUPERIORITY||Response rate difference|0.07||||0.2202|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.05|0.2202
74096722|NCT03233230|147742587|SUPERIORITY||Response rate difference|0.07||||0.2328|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.05|0.2328
74096723|NCT03233230|147742588|SUPERIORITY||Response rate difference|0.06||||0.1232|TWO_SIDED|95.0|-0.02|0.15|||Cochran-Mantel-Haenszel|||||0.15|-0.02|0.1232
74096724|NCT03233230|147742588|SUPERIORITY||Response rate difference|0.05||||0.1725|TWO_SIDED|95.0|-0.03|0.14|||Cochran-Mantel-Haenszel|||||0.14|-0.03|0.1725
74096725|NCT03233230|147742588|SUPERIORITY||Response rate difference|0.05||||0.1795|TWO_SIDED|95.0|-0.03|0.13|||Cochran-Mantel-Haenszel|||||0.13|-0.03|0.1795
74096726|NCT03233230|147742596|SUPERIORITY||Response rate difference|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||||0.04|-0.04|
74018191|NCT00915343|147587873|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.9||||0.3405|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score||||0.3405
74018192|NCT00915343|147587874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8418|TWO_SIDED||||||Wilcoxon Signed Rank|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score||||0.8418
74018193|NCT00915343|147587874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.355|TWO_SIDED||||||Wilcoxon Signed Rank test|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score||||0.3550
74018194|NCT00915343|147587875|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-2.9||||0.0823|TWO_SIDED||||||Fisher's|Fisher's non-parametric two-sample permutation test||||||0.0823
74018195|NCT00915343|147587876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5982|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.5982
74018196|NCT00915343|147587877|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|2.3||||0.0632|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||||||0.0632
74018197|NCT00915343|147587878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8676|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.8676
74018198|NCT00915343|147587879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.9700
74018199|NCT00915343|147587880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2624|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.2624
74018200|NCT00915343|147587881|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|1.28|||||TWO_SIDED|||||||||||||
74018201|NCT00915343|147587883|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Sign test|||||||<0.0001
74018202|NCT00915343|147587884|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-272.3||||0.0034|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0034
74018203|NCT01920711|147587885|SUPERIORITY||Rate Ratio|0.8698||||0.0587|TWO_SIDED|95.0|0.7526|1.0052||1-sided p-value 0.0294|Proportional Rates Model (LWYY)|Treatment as fixed-effect factor and stratified by region and with robust variance estimate.||Primary Composite Events||1.0052|0.7526|0.0587
74018204|NCT01920711|147587885|SUPERIORITY||Rate Ratio|0.8511||||0.0556|TWO_SIDED|95.0|0.7216|1.0039||1-sided p-value 0.0278|Joint Frality Model|Treatment and region as fixed-effect factors||Total Hospitalizations for heart failure||1.0039|0.7216|0.0556
74018205|NCT01920711|147587885|SUPERIORITY||Hazard Ratio (HR)|0.9531||||0.6241|TWO_SIDED|95.0|0.7863|1.1551||1-sided p-value 0.3120|Cox's proportional hazard model|||Cardiovascular Death||1.1551|0.7863|0.6241
74018206|NCT01920711|147587886|SUPERIORITY||Least Squares Mean of Difference|1.0264||||0.051|TWO_SIDED|95.0|-0.0047|2.0576|||Mixed Models Analysis|||Clinical Summary Score||2.0576|-0.0047|0.0510
74018207|NCT01920711|147587887|SUPERIORITY||Odds Ratio (OR)|1.4475||||0.0035|TWO_SIDED|95.0|1.1294|1.8552|||Repeated measures cumulative odds model|The response variable is the change from baseline to any scheduled time points up to Month 8.||NYHA Class Change||1.8552|1.1294|0.0035
74018208|NCT01920711|147587888|SUPERIORITY||Hazard Ratio (HR)|0.5041||||0.0014|TWO_SIDED|95.0|0.3312|0.7673|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Composite renal endpoint||0.7673|0.3312|0.0014
73880738|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.88||||0.0366|TWO_SIDED|95.0|0.52|6.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.85|0.52|0.0366
73880739|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|0.84||||0.7968|TWO_SIDED|95.0|0.23|3.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.05|0.23|0.7968
73880740|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9074|TWO_SIDED|95.0|0.3|3.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.81|0.30|0.9074
73880741|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|0.41||||0.1987|TWO_SIDED|95.0|0.1|1.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.60|0.10|0.1987
73880742|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|2.58||||0.204|TWO_SIDED|95.0|0.6|11.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||11.18|0.60|0.2040
74018209|NCT01920711|147587888|SUPERIORITY||Hazard Ratio (HR)|0.9295||||0.9588|TWO_SIDED|95.0|0.0581|14.861|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Renal Death||14.861|0.0581|0.9588
74018210|NCT01920711|147587888|SUPERIORITY||Hazard Ratio (HR)|0.5774||||0.2484|TWO_SIDED|95.0|0.2272|1.4672|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Reaching ESRD||1.4672|0.2272|0.2484
74018211|NCT01920711|147587888|SUPERIORITY||Hazard Ratio (HR)|0.4407||||0.0004|TWO_SIDED|95.0|0.2798|0.6942|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||\>=50% decline in eGFR from baseline||0.6942|0.2798|0.0004
74018212|NCT01920711|147587889|SUPERIORITY||Hazard Ratio (HR)|0.9696||||0.6846|TWO_SIDED|95.0|0.8352|1.1255|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||All-cause mortality||1.1255|0.8352|0.6846
74018213|NCT01634555|147587891|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.93|||||TWO_SIDED|90.0|0.83|1.05|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1 for Irinotecan .||||1.05|0.83|
74018214|NCT01634555|147587891|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.95|||||TWO_SIDED|90.0|0.88|1.04|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1 for Metabolite SN-38.||||1.04|0.88|
74018215|NCT01634555|147587893|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|1.04|||||TWO_SIDED|90.0|0.97|1.12|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1 for Irinotecan.||||1.12|0.97|
74018216|NCT01634555|147587893|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.97|||||TWO_SIDED|90.0|0.85|1.12|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1 for Metabolite SN-38.||||1.12|0.85|
74018217|NCT00805740|147587896|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.8|||||TWO_SIDED|95.0|-12.3|53.3||||||The 95 percent (%) confidence interval (CI) was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||53.3|-12.3|
74018218|NCT00805740|147587897|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.6|||||TWO_SIDED|95.0|-13.6|55.6||||||2-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||55.6|-13.6|
74018219|NCT00805740|147587897|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1|||||TWO_SIDED|95.0|-23.3|47.3||||||6-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||47.3|-23.3|
74018220|NCT00805740|147587899|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.1|||||TWO_SIDED|95.0|-39.0|27.9||||||The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||27.9|-39.0|
74018221|NCT04033367|147587905|SUPERIORITY||Least square mean difference|-15.52|||<|0.001|TWO_SIDED|95.0|-24.13|-6.9||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.||-6.90|-24.13|<0.001
74018222|NCT04033367|147587906|SUPERIORITY||Least square mean difference|-27.87|||<|0.001|TWO_SIDED|95.0|-37.96|-17.78||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-17.78|-37.96|<0.001
74018223|NCT04033367|147587907|SUPERIORITY||Least square mean difference|-15.06|||<|0.001|TWO_SIDED|95.0|-20.56|-9.56||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-9.56|-20.56|<0.001
74018224|NCT04033367|147587908|SUPERIORITY||Least square mean difference|-2.08|||<|0.001|TWO_SIDED|95.0|-2.97|-1.18||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-1.18|-2.97|<0.001
74046800|NCT01804842|147645743|SUPERIORITY_OR_OTHER||% Ratio of LS Means|83.8||||0.1595|TWO_SIDED|90.0|68.1|103.23|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of LS means and the comparator for the p-values.||103.23|68.10|0.1595
74046801|NCT01804842|147645743|SUPERIORITY_OR_OTHER||% Ratio of LS Means|111.3||||0.3867|TWO_SIDED|90.0|90.37|136.99|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||136.99|90.37|0.3867
74046802|NCT01804842|147645743|SUPERIORITY_OR_OTHER||% Ratio of LS Means|132.7||||0.0294|TWO_SIDED|90.0|107.78|163.39|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||163.39|107.78|0.0294
74046803|NCT01804842|147645744|SUPERIORITY_OR_OTHER||% Ratio of LS Means|91.0||||0.0028|TWO_SIDED|95.0|85.7|96.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||96.67|85.70|0.0028
74046804|NCT01804842|147645744|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.9||||0.0024|TWO_SIDED|95.0|85.58|96.53|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||96.53|85.58|0.0024
74046805|NCT01804842|147645744|SUPERIORITY_OR_OTHER||% Ratio of LS Means|95.1||||0.0992|TWO_SIDED|95.0|89.54|100.99|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||100.99|89.54|0.0992
74046806|NCT01804842|147645745|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.4||||0.0006|TWO_SIDED|95.0|85.55|95.56|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||95.56|85.55|0.0006
74046807|NCT01804842|147645745|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.5||||0.0007|TWO_SIDED|95.0|85.65|95.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||95.67|85.65|0.0007
74046808|NCT01804842|147645745|SUPERIORITY_OR_OTHER||% Ratio of LS Means|94.3||||0.0389|TWO_SIDED|95.0|89.24|99.69|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||99.69|89.24|0.0389
74046809|NCT00628134|147645746|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons||||0.07
74046810|NCT00628134|147645747|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons||||0.29
74046811|NCT03687827|147645752|SUPERIORITY|Superiority is confirmed if non-inferiority is confirmed and the lower limit of the two-sided 95% confidence interval is entirely above zero.|Estimated treatment difference|1.43||||0.0321|TWO_SIDED|95.0|0.12|2.74|||t-test, 2 sided|||||2.74|0.12|0.0321
74046812|NCT03687827|147645752|NON_INFERIORITY|A non-inferiority margin of -0.83% has been applied, corresponding to 0.2 hours/24 hours|Estimated treatment difference|1.43|||||TWO_SIDED|95.0|0.12|2.74||||||||2.74|0.12|
74046813|NCT02128958|147645758|OTHER|||||||0.536|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) of Overall Survival will be performed using the log rank test as the primary analysis.||||0.536
74046814|NCT02128958|147645759|OTHER|||||||0.371|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) of Time to Progression will be performed using the log rank test as the primary analysis.||||.371
74046815|NCT02128958|147645760|OTHER|||||||0.521|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) will be performed on Time to Progression Free Survival using the logrank test.||||0.521
74096727|NCT03233230|147742596|SUPERIORITY||Response rate difference|0.01|||||TWO_SIDED|95.0|-0.03|0.06||||||||0.06|-0.03|
74096728|NCT03233230|147742596|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
74096729|NCT03233230|147742597|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.02|0.09||||||||0.09|-0.02|
74096730|NCT03233230|147742597|SUPERIORITY||Response rate difference|0.05|||||TWO_SIDED|95.0|0.0|0.12||||||||0.12|-0.00|
74046816|NCT02128958|147645763|OTHER|||||||0.988|||||||ANCOVA|||Between-treatment comparisons of ALT will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.988
74046817|NCT02128958|147645763|OTHER|||||||0.989|||||||ANCOVA|||Between-treatment comparisons of AST will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.989
74046818|NCT02128958|147645763|OTHER|||||||0.717|||||||ANCOVA|||Between-treatment comparisons of Albumin will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.717
74046819|NCT02128958|147645763|OTHER|||||||0.891|||||||ANCOVA|||Between-treatment comparisons of Bilirubin (direct) will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.891
74046820|NCT02128958|147645763|OTHER|||||||0.275|||||||ANCOVA|||Between-treatment comparisons of Bilirubin (Total) will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.275
74046821|NCT02128958|147645763|OTHER|||||||0.549|||||||ANCOVA|||Between-treatment comparisons of PT will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.549
74096731|NCT03233230|147742597|SUPERIORITY||Response rate difference|0.02|||||TWO_SIDED|95.0|-0.03|0.08||||||||0.08|-0.03|
74096732|NCT03233230|147742598|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
74096733|NCT03233230|147742598|SUPERIORITY||Response rate difference|0.04|||||TWO_SIDED|95.0|0.0|0.1||||||||0.10|0.00|
74096734|NCT03233230|147742598|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
74096735|NCT03233230|147742599|SUPERIORITY||Response rate difference|0.11|||||TWO_SIDED|95.0|-0.03|0.24||||||||0.24|-0.03|
74096736|NCT03233230|147742599|SUPERIORITY||Response rate difference|0.12|||||TWO_SIDED|95.0|-0.02|0.25||||||||0.25|-0.02|
74096737|NCT03233230|147742599|SUPERIORITY||Response rate difference|0.18|||||TWO_SIDED|95.0|0.05|0.31||||||||0.31|0.05|
74096738|NCT01898650|147742628|SUPERIORITY|||||||0.004||||||no adjustments for multiple comparisons were made. the threshold for significance was set a priori at 0.05.|t-test, 1 sided|||Null hypothesis was that blood flow would be equivalent on the unaffected and affected sides.||||0.004
74096739|NCT00911807|147742629|SUPERIORITY_OR_OTHER||Mean Square (Factor Treatment)|19.59||||0.6348||||||ANCOVA F-test. The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|ANCOVA|ANCOVA with the week 28 ADAS-cog+ change score as dependent variable and the ADAS-cog+ baseline score as a covariate.||The null-hypothesis stated no differences between the three treatment groups regarding the mean change from baseline in ADAS-cog+ at week 28. A sample size of approximately 60 evaluable patients per treatment arm was estimated to allow for the detection of a significant group difference of two points in ADAS-cog+ week 28 change score (standard deviation \[SD\] 3.3) between the three groups with a power of \> 80% and a probability level of alpha = 0.05 (two-sided).||||0.6348
74096740|NCT00911807|147742629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.583||95.0|-2.891|1.63||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'||1.630|-2.891|0.5830
74096741|NCT00911807|147742629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.3434||95.0|-3.324|1.163||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.||1.163|-3.324|0.3434
74096742|NCT00911807|147742629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.6962||95.0|-2.719|1.819||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.||1.819|-2.719|0.6962
74096743|NCT02304991|147742641|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero||||0.002
74096744|NCT02304991|147742642|SUPERIORITY|||||||0.0005|||||||t-test, 2 sided|||Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero||||0.0005
74096745|NCT02304991|147742643|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
74096746|NCT02304991|147742644|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Per protocol analysis of patients with available samples.||||0.01
74096747|NCT02304991|147742645|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Per protocol analysis of patients with available samples.||||<0.0001
73880743|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|0.51||||0.3318|TWO_SIDED|95.0|0.13|1.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.99|0.13|0.3318
74096748|NCT02304991|147742646|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
74096749|NCT04430855|147742647|SUPERIORITY||Response Rate Difference|13.3||||0.018|TWO_SIDED|95.0|-0.6|27.2|||Chi-squared||Response rate difference compared to historical placebo = upadacitinib 30 mg - historical placebo|The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved HiSCR response to that of a prespecified, single historical placebo rate (25%). The historical placebo rate of 25% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).||27.2|-0.6|0.018
74096750|NCT04430855|147742647|SUPERIORITY||Adjusted Response Rate Difference|9.2||||0.142|TWO_SIDED|95.0|-7.6|25.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)|As a supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo HiSCR data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic HiSCR was 29.2%.||25.9|-7.6|0.142
74096751|NCT04430855|147742647|SUPERIORITY||Adjusted Response Rate Difference|14.7||||0.087|TWO_SIDED|95.0|-6.6|36.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo|As an additional supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.||36.0|-6.6|0.087
73880744|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7437|TWO_SIDED|95.0|0.31|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.10|0.31|0.7437
74096752|NCT04430855|147742648|SUPERIORITY||Response Rate Difference|13.9||||0.028|TWO_SIDED|95.0|-2.5|30.3|||Chi-squared||Response rate difference compared to historical placebo (upadacitinib 30 mg - historical placebo)|The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved NRS30 response to that of a prespecified, single historical placebo rate (22.5%). The historical placebo rate of 22.5% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).||30.3|-2.5|0.028
74046822|NCT02128958|147645763|OTHER|||||||0.479|||||||ANCOVA|||Between-treatment comparisons of INR will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.479
74046823|NCT00262639|147645784|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||||||0.03
74046824|NCT00262639|147645785|SUPERIORITY|||||||0.0006||||||This p value is for the interaction of AW status by medication group.|ANOVA|||The analysis was an ANOVA interaction analysis with alcohol withdrawal (AW) group (Low vs. High) by medication group (active versus placebo medication) across the 6 weeks of the medication trial.||||0.0006
74046825|NCT02736929|147645796|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.12|TWO_SIDED|95.0|-2.7|22.3|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up||22.3|-2.7|0.12
74046826|NCT02736929|147645797|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.024|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.5|0.1|0.024
74046827|NCT02736929|147645798|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.027|TWO_SIDED|95.0|0.0|0.6|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.6|0.0|0.027
74046828|NCT02736929|147645799|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.024|TWO_SIDED|95.0|0.5|7.1|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||7.1|0.5|0.024
74046829|NCT02736929|147645800|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.19|TWO_SIDED|95.0|-9.8|2.0|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||2.0|-9.8|0.19
74046830|NCT02736929|147645801|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.31|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.4|-1.3|0.31
74046831|NCT02736929|147645802|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||1.5|-1.8|0.86
74046832|NCT02736929|147645803|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.77|TWO_SIDED|95.0|-1.7|1.2|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||1.2|-1.7|0.77
74046833|NCT01690988|147645815|OTHER|Test of independence|Difference in Percentages|0.36|STANDARD_ERROR_OF_MEAN|3.301||0.912|TWO_SIDED|95.0|-6.07|7.38|||Chi-squared||Difference in delirium incidence between placebo control and combined ketamine groups.|The primary analysis was a comparison between the placebo control group and the combined ketamine groups||7.38|-6.07|0.912
74046834|NCT01690988|147645816|SUPERIORITY|||||||0.964|||||||ANOVA|one-way||We compared the combined average pain level (pain level at rest, taking a deep breath, and/or when moving) over the entire day (AM and PM).||||0.964
74046835|NCT01690988|147645817|SUPERIORITY|||||||0.476|||||||ANOVA|||"All morphine equivalent drugs consumed by patients perioperatively~Opioid Drugs included:~\* Postoperatively while still in hospital, the list of pain medication used included Morphine, Hydromorphone, Meperidine, Nalbuphine, Oxycodone,Oxymorphone, Tramadol, bupivacaine, (Codeine, Fentanyl, Naloxone) Total Opiates (Morphine Equivalent) in milligrams The median(IQR) opioid consumption was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg)"||||0.476
74046836|NCT01690988|147645818|SUPERIORITY||frequency-test|0.572||||0.572|TWO_SIDED||||||Chi-squared|||"Assessed from patient-reported postoperative nausea and vomiting section of Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) Patients where asked whether they currently have nausea/vomiting AM \& PM the response choices: None, Mild, Moderate, Severe Incidence of nausea\\vomiting accounted for any positive reporting(Mild, moderate, or sever) Daily incidence accounted for any positive incidence AM/PM in each POD Any POD nausea/vomiting reports the incidence across day 1-3"||||0.572
74046837|NCT01690988|147645820|SUPERIORITY|||||||0.01|||||||Chi-squared|||Frequency of patients reporting hallucinations using the DSAQ instrument.||||0.01
74046838|NCT01690988|147645821|SUPERIORITY|||||||0.03||||||"Patients where asked whether Following their surgery they had bad dreams or nightmares the response choices: Yes/No question The incidence of hallucination and nightmares were assessed separately and compared across the three study group."|Chi-squared|||||||0.03
74046839|NCT00638274|147645823|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
74046840|NCT00638274|147645823|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
74046841|NCT01634100|147645862|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|135.2|STANDARD_DEVIATION|7.3|||TWO_SIDED|90.0|129.58|141.06|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||141.06|129.58|
74046842|NCT01634100|147645862|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.47|STANDARD_DEVIATION|7.4|||TWO_SIDED|90.0|146.41|160.88|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||160.88|146.41|
74046843|NCT01634100|147645863|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|175.14|STANDARD_DEVIATION|15.4|||TWO_SIDED|90.0|160.14|191.56|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||191.56|160.14|
74046844|NCT01634100|147645863|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|125.6|STANDARD_DEVIATION|15.9|||TWO_SIDED|90.0|113.67|138.78|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||138.78|113.67|
74046845|NCT01634100|147645864|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|136.42|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|130.61|142.48|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||142.48|130.61|
74046846|NCT01634100|147645864|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.61|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|146.5|161.06|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||161.06|146.50|
74046847|NCT01487863|147645872|SUPERIORITY|||||||0.2141|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.2141
74046848|NCT00893763|147645883|SUPERIORITY_OR_OTHER|||||||0.1763|TWO_SIDED||||||mixed effects linear model|||We compared groups in a single analytical model using a mixed effects linear model with CPIS as the response variable. For this model, group (CHX, control), day, group by day interaction, APACHE III score and hospital (VCU, USF) were modeled as fixed effects and subject was modeled as a random effect.||||0.1763
74046849|NCT00893763|147645883|SUPERIORITY_OR_OTHER|||||||0.8656|TWO_SIDED||||||Regression, Logistic|||A logistic regression analysis was performed using the binary response variable of colonization or no colonization and dependent variables for group, length of intubation, and group-by-length-of-intubation interaction. The probability of a type 1 error ( a ) was set to 0.05.||||0.8656
74046850|NCT01512693|147645887|NON_INFERIORITY_OR_EQUIVALENCE|Similarity will be concluded if the GMR (moderate hepatic insufficiency / healthy) is contained within the interval \[0.40, 2.50\].|GMR|0.85|||||TWO_SIDED|90.0|0.61|1.19||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (moderate hepatic insufficiency / healthy) and 90% confidence intervals.||1.19|0.61|
74046851|NCT01512693|147645888|SUPERIORITY_OR_OTHER||GMR|0.71|||||TWO_SIDED|90.0|0.51|1.0||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (moderate hepatic insufficiency / healthy) and 90% confidence intervals.||1.00|0.51|
74046852|NCT01975376|147645891|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.930905|TWO_SIDED|95.0|0.8|1.22|||Log Rank|||Hazard ratio and 95 percent (%) Confidence Interval (CI) were from a Cox proportional hazards model stratified by geographic region and low density lipoprotein cholesterol (LDL-C) at pre-screening (less than \[\<\] 100 milligrams per deciliters \[mg/dL\], greater than and equal to \[\>=\] 100 mg/dL) with treatment as a co-variate.||1.22|0.80|0.930905
74096753|NCT04430855|147742648|SUPERIORITY||Adjusted Response Rate Difference|4.5||||0.323|TWO_SIDED|95.0|-14.6|23.5||Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Cochran-Mantel-Haenszel||Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)|As a supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo NRS30 data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic NRS30 was 31.3%.||23.5|-14.6|0.323
74096754|NCT04430855|147742648|SUPERIORITY||Adjusted Response Rate Difference|2.2||||0.421|TWO_SIDED|95.0|-19.6|24.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo|As an additional supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.||24.0|-19.6|0.421
74096755|NCT04874636|147742659|SUPERIORITY||Posterior Mean Difference|0.08|||||TWO_SIDED|95.0|-0.59|0.75|||||Posterior mean difference with 95% credible interval is reported.|||0.75|-0.59|
74096756|NCT04874636|147742660|SUPERIORITY||Posterior Mean Difference|0.49|||||TWO_SIDED|95.0|-1.02|2.0|||||Posterior mean difference with 95% credible interval is reported.|||2.00|-1.02|
74096757|NCT04874636|147742661|SUPERIORITY||Posterior Mean Difference|0.14|||||TWO_SIDED|95.0|-0.27|0.55|||||Posterior mean difference with 95% credible interval is reported.|||0.55|-0.27|
74096758|NCT04874636|147742662|SUPERIORITY||Posterior Mean Difference|0.29|||||TWO_SIDED|95.0|-0.43|1.02|||||Posterior mean difference with 95% credible interval is reported.|||1.02|-0.43|
74096759|NCT04874636|147742663|SUPERIORITY||Posterior Mean Difference|7.9|||||TWO_SIDED|95.0|-0.32|16.14|||||Posterior mean difference with 95% credible interval is reported.|||16.14|-0.32|
74096760|NCT04874636|147742664|SUPERIORITY||Posterior Mean Difference|-0.17|||||TWO_SIDED|95.0|-0.65|0.3|||||Posterior mean difference with 95% credible interval is reported.|||0.30|-0.65|
74096761|NCT04874636|147742665|SUPERIORITY||Posterior Mean Difference|-34.98|||||TWO_SIDED|95.0|-176.34|106.69|||||Posterior mean difference with 95% credible interval is reported.|||106.69|-176.34|
74096762|NCT04874636|147742666|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.1|0.09|||||Posterior mean difference with 95% credible interval is reported.|||0.09|-0.10|
74096763|NCT01770392|147742667|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|50.12|STANDARD_DEVIATION|12.7||1|TWO_SIDED|90.0|47.155|53.275||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)"|||53.275|47.155|1.0000
73880745|NCT03192176|147297625|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6848|TWO_SIDED|95.0|0.36|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.71|0.36|0.6848
74046853|NCT01975376|147645892|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.784265|TWO_SIDED|95.0|0.82|1.3|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.30|0.82|0.784265
74046854|NCT01975376|147645893|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.892441|TWO_SIDED|95.0|0.81|1.2|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.20|0.81|0.892441
74046855|NCT01975376|147645894|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.845797|TWO_SIDED|95.0|0.83|1.26|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.26|0.83|0.845797
74046856|NCT01975376|147645895|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.431903|TWO_SIDED|95.0|0.49|1.36|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.36|0.49|0.431903
74046857|NCT01975376|147645896|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.883797|TWO_SIDED|95.0|0.8|1.21|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.21|0.80|0.883797
74046858|NCT01975376|147645897|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.45569|TWO_SIDED|95.0|0.74|1.95|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.95|0.74|0.455690
74046859|NCT01975376|147645898|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.469496|TWO_SIDED|95.0|0.84|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.48|0.84|0.469496
74046860|NCT01975376|147645899|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.633022|TWO_SIDED|95.0|0.26|9.23|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||9.23|0.26|0.633022
74046861|NCT01975376|147645900|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.46765|TWO_SIDED|95.0|0.83|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.48|0.83|0.467650
74046862|NCT01975376|147645901|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.015462|TWO_SIDED|95.0|0.32|0.89|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.89|0.32|0.015462
74046863|NCT01975376|147645902|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.011863|TWO_SIDED|95.0|0.33|0.88|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.88|0.33|0.011863
74046864|NCT01975376|147645903|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.316066|TWO_SIDED|95.0|0.12|2.0|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||2.00|0.12|0.316066
74046865|NCT01975376|147645904|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.020328|TWO_SIDED|95.0|0.3|0.91|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.91|0.30|0.020328
74096764|NCT01770392|147742668|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|59.76|STANDARD_DEVIATION|21.9||1|TWO_SIDED|90.0|53.829|66.348||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."|||66.348|53.829|1.0000
74046866|NCT01975376|147645905|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.367069|TWO_SIDED|95.0|0.53|1.27|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.27|0.53|0.367069
74046867|NCT01975376|147645906|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.443081|TWO_SIDED|95.0|0.56|1.29|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.29|0.56|0.443081
74046868|NCT01975376|147645907|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.343817|TWO_SIDED|95.0|0.71|1.12|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.12|0.71|0.343817
74046869|NCT01975376|147645908|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.889065|TWO_SIDED|95.0|0.59|1.85|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.85|0.59|0.889065
74046870|NCT01975376|147645909|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.308388|TWO_SIDED|95.0|0.69|1.13|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.13|0.69|0.308388
74046871|NCT01975376|147645910|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.874835|TWO_SIDED|95.0|0.74|1.42|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.42|0.74|0.874835
74096765|NCT01770392|147742669|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|49.98|STANDARD_DEVIATION|13.3||1|TWO_SIDED|90.0|46.886|53.286||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."|||53.286|46.886|1.0000
74096766|NCT03258853|147742703|SUPERIORITY|||||||0.001|||||||paired 2-sided t-test|||||||0.001
74096767|NCT03258853|147742704|SUPERIORITY|||||||1||||||Secondary outcomes were adjusted for multiple comparisons|Wilcoxon signed rank test|||||||1.0
73880746|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1114|TWO_SIDED|95.0|0.84|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.32|0.84|0.1114
73880747|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|4.69||||0.0013|TWO_SIDED|95.0|1.83|12.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.04|1.83|0.0013
73880748|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|7.01|||<|0.0001|TWO_SIDED|95.0|2.65|18.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.54|2.65|<0.0001
73880749|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|4.96||||0.001|TWO_SIDED|95.0|1.91|12.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.89|1.91|0.0010
73880750|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6384|TWO_SIDED|95.0|0.49|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||3.22|0.49|0.6384
74046872|NCT01975376|147645911|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.526269|TWO_SIDED|95.0|0.79|1.6|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.60|0.79|0.526269
74046873|NCT01975376|147645912|SUPERIORITY||LS-mean difference|-60.57|||<|0.001|TWO_SIDED|95.0|-61.43|-59.71|||Mixed Effect Model Repeat Measurement|||Lease Square (LS)- mean differences, associated 95% CI, and p-values were from a mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-59.71|-61.43|<0.001
74046874|NCT01975376|147645913|SUPERIORITY||LS-mean difference|-54.7|||<|0.001|TWO_SIDED|95.0|-55.48|-53.92|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-53.92|-55.48|<0.001
74046875|NCT01975376|147645914|SUPERIORITY||LS-mean difference|-46.72|||<|0.001|TWO_SIDED|95.0|-47.68|-45.76|||ANCOVA|||LS- mean difference and associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-45.76|-47.68|<0.001
74046876|NCT01975376|147645915|SUPERIORITY||LS-mean difference|-54.88|||<|0.001|TWO_SIDED|95.0|-55.66|-54.09|||Mixed Effect Model Repeat Measurement|||Non-HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-54.09|-55.66|<0.001
74046877|NCT01975376|147645915|SUPERIORITY||LS-mean difference|-36.51|||<|0.001|TWO_SIDED|95.0|-37.07|-35.95|||Mixed Effect Model Repeat Measurement|||Total cholesterol: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-35.95|-37.07|<0.001
74046878|NCT01975376|147645915|SUPERIORITY||LS-mean difference|-20.17|||<|0.001|TWO_SIDED|95.0|-21.42|-18.93|||Mixed Effect Model Repeat Measurement|||VLDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-18.93|-21.42|<0.001
74046879|NCT01975376|147645915|SUPERIORITY||LS-Mean Difference|-30.25|||<|0.001|TWO_SIDED|95.0|-32.44|-28.07|||Mixed Effect Model Repeat Measurement|||RLP-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-28.07|-32.44|<0.001
74046880|NCT01975376|147645915|SUPERIORITY||LS-Mean Difference|-58.55|||<|0.001|TWO_SIDED|95.0|-59.42|-57.69|||Mixed Effect Model Repeat Measurement|||Apo B: LS -mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-57.69|-59.42|<0.001
74046881|NCT01975376|147645915|SUPERIORITY||LS-Mean Difference|6.14|||<|0.001|TWO_SIDED|95.0|5.69|6.59|||Mixed Effect Model Repeat Measurement|||HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||6.59|5.69|<0.001
74096768|NCT03258853|147742705|SUPERIORITY|||||||0.04||||||Secondary outcomes are adjusted for multiple comparisons|paired 2-sided t-test|||||||0.04
74096769|NCT03258853|147742706|SUPERIORITY|||||||1||||||Adjusted for multiple comparisons|Wicoxon signed rank test|||||||1.0
74096770|NCT03258853|147742707|SUPERIORITY|||||||0.014||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.014
74096771|NCT03258853|147742708|SUPERIORITY|||||||0.014||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.014
74096772|NCT03258853|147742709|SUPERIORITY|||||||0.14||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.14
74046882|NCT01975376|147645915|SUPERIORITY||LS-Mean Difference|3.53|||<|0.001|TWO_SIDED|95.0|3.02|4.03|||Mixed Effect Model Repeat Measurement|||Apo A-I: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||4.03|3.02|<0.001
74046883|NCT01975376|147645916|SUPERIORITY||LS-mean difference|0.67|||<|0.001|TWO_SIDED|95.0|0.66|0.68|||Mixed Effect Model Repeat Measurement|||Lp (a): LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||0.68|0.66|<0.001
74046884|NCT01975376|147645916|SUPERIORITY||LS-mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.8|0.81|||Mixed Effect Model Repeat Measurement|||Triglycerides: LS- mean differences and associated 95% CI, and p-values were from an MMRM model through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||0.81|0.80|<0.001
74046885|NCT01975376|147645917|SUPERIORITY||LS-mean difference|1.06|||<|0.001|TWO_SIDED|95.0|1.03|1.1|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||1.10|1.03|<0.001
74046886|NCT01378299|147645962|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with last value carry forward.||||<0.05
74046887|NCT01378299|147645963|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward||||<0.05
74046888|NCT01378299|147645964|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
74096773|NCT03258853|147742710|SUPERIORITY|||||||1||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||1.0
74046889|NCT01378299|147645965|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
74046890|NCT01378299|147645966|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
74046891|NCT01378299|147645967|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
74046892|NCT01378299|147645968|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
74046893|NCT01378299|147645970|OTHER||||||<|0.05|||||||ANOVA|||Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline and with acceptable assay coefficient of variability were included in the analysis. The data of 79 subjects were analyzed; 15 in the GG, 43 in the GA and 21 in the AA genotype.||||<0.05
74046894|NCT01378299|147645971|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
74046895|NCT01378299|147645972|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
74046896|NCT01378299|147645973|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
74046897|NCT01448707|147645987|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5%.|Non-Linear mixed|-7.9||||0.2331|TWO_SIDED|95.0|-14.64|-1.19||P-Value for non-inferiority of DRV/rtv MONO vs DRV/rtv + 2NRTIs (delta = 12%).|Mixed Models Analysis|Predicted response rate:confidence limits are obtained by means of logistic regression model with treatment group and Hepatitis C status as covariates||||-1.19|-14.64|0.2331
74046898|NCT01448707|147645988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-Linear mixed|-10.1||||0.6933|TWO_SIDED|95.0|-19.5|-0.73|||Mixed Models Analysis|||||-0.73|-19.50|0.6933
74046899|NCT01448707|147645989|NON_INFERIORITY_OR_EQUIVALENCE|Week 48: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-linear mixed model|-3.5||||0.0016|TWO_SIDED|95.0|-8.77|1.72|||Mixed Models Analysis|||||1.72|-8.77|0.0016
74046900|NCT01448707|147645989|NON_INFERIORITY_OR_EQUIVALENCE|Week 96: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|non-linear mixed model|-0.7||||0.0022|TWO_SIDED|95.0|-7.89|6.58|||Mixed Models Analysis|||||6.58|-7.89|0.0022
74096774|NCT03258853|147742711|SUPERIORITY|||||||0.01|||||||Wilcoxon signed rank test|||||||0.01
74096775|NCT03258853|147742712|SUPERIORITY|||||||0.08|||||||McNemar|||||||0.08
74096776|NCT03258853|147742713|SUPERIORITY|||||||0.56|||||||McNemar|||||||0.56
74096777|NCT03258853|147742714|SUPERIORITY|||||||0.56|||||||McNemar|||||||0.56
74096778|NCT03258853|147742715|SUPERIORITY|||||||0.15|||||||McNemar|||||||0.15
74096779|NCT02569112|147742716|SUPERIORITY|A significant improvement in skin laxity reduction is defined as a mean average increase in grade of 1 as per the GAIS.|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Used Wilcoxon Matched-Pairs Signed-Ranks test||The null hypothesis was that the addition of the multipolar radiofrequency with varipulse technology treatment to the cryolipolysis treatment would not show visual improvement.||||<0.01
74096780|NCT01540773|147742717|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
74096781|NCT01540773|147742718|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
74096782|NCT01398943|147742725|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74096783|NCT01398943|147742725|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74096784|NCT01398943|147742726|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74096785|NCT01398943|147742726|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73880751|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|5.77||||0.0003|TWO_SIDED|95.0|2.23|14.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.93|2.23|0.0003
73880752|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0025|TWO_SIDED|95.0|1.65|10.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||10.45|1.65|0.0025
74046901|NCT02623699|147646040|SUPERIORITY||least square (LS) mean difference|1.2|STANDARD_ERROR_OF_MEAN|2.22|=|0.9689|TWO_SIDED|95.0|-3.19|5.53||Joint rank p-value was calculated from ANCOVA model which included treatment as fixed effect, adjusts for covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, and use of riluzole or edaravone.|Joint rank||ANCOVA model included treatment as a fixed effect, adjusts for the covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, and use of riluzole or edaravone.|Joint rank test combining function and mortality were used for statistical inference and the estimates were from the Analysis of covariance (ANCOVA) for change from baseline. Multiple imputation was used to handle missing data for withdrawals other than death in the joint rank analysis. Multiple imputation was used to handle all missing data in the ANCOVA for change from baseline.||5.53|-3.19|= 0.9689
74046902|NCT02623699|147646041|SUPERIORITY||Difference in LS geometric mean ratio|0.67|||<|0.0001|TWO_SIDED|95.0|0.53|0.84|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.84|0.53|< 0.0001
74046903|NCT02623699|147646041|SUPERIORITY||Difference in LS geometric mean ratio|0.75|||=|0.0002|TWO_SIDED|95.0|0.6|0.95|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.95|0.60|=0.0002
74046904|NCT02623699|147646041|SUPERIORITY||Difference in LS geometric mean ratio|0.81|||=|0.0641|TWO_SIDED|95.0|0.65|1.02|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||1.02|0.65|=0.0641
74046905|NCT02623699|147646041|SUPERIORITY||Difference in LS geometric mean ratio|0.67|||<|0.0001|TWO_SIDED|95.0|0.53|0.84|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.84|0.53|<0.0001
74046906|NCT02623699|147646042|SUPERIORITY||Difference in LS geometric mean ratio|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78||The analysis was based on ANCOVA model with natural log transformed data. P-value for this secondary outcome measure (OM) is nominal as statistical significance was not met on the primary OM.|ANCOVA|||The ANCOVA model included covariates for the corresponding baseline value i.e. log value, baseline disease duration since symptom onset, and use of riluzole or edaravone. Multiple imputation was used to handle missing data for withdrawals. Difference in LS geometric mean ratio to baseline (BIIB067:Placebo) was calculated.||0.78|0.49|< 0.0001
74046907|NCT02623699|147646043|SUPERIORITY||Difference in LS geometric mean ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.25|0.45||The analysis was based on ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, baseline disease duration since symptom onset, and use of riluzole or edaravone.|ANCOVA|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.45|0.25|< 0.0001
73880753|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0279|TWO_SIDED|95.0|1.12|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.12|1.12|0.0279
73880754|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0114|TWO_SIDED|95.0|1.31|8.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.61|1.31|0.0114
73888082|NCT01746901|147309535|SUPERIORITY_OR_OTHER||LS Mean Difference|13.3||||0.0217|TWO_SIDED|95.0|2.0|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.6|2.0|0.0217
74046908|NCT02623699|147646044|SUPERIORITY||LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|5.829|=|0.3233|TWO_SIDED|95.0|-3.528|19.322||Joint rank p-value was calculated from ANCOVA model which included treatment as fixed effect, adjusts for covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, baseline SVC, and use of riluzole or edaravone.|Joint rank|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.|ANCOVA model included treatment as a fixed effect, adjusts for the covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, baseline SVC, and use of riluzole or edaravone.|Joint rank test combining function and mortality were used for statistical inference and the estimates were from the ANCOVA for change from baseline. Multiple imputation was used to handle missing data for withdrawals other than death in the joint rank analysis. Multiple imputation was used to handle all missing data in the ANCOVA for change from baseline.||19.322|-3.528|= 0.3233
74046909|NCT02623699|147646045|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.118|=|0.839|TWO_SIDED|95.0|-0.207|0.255||ANCOVA model included treatment as fixed effect and adjusts for following covariates: Baseline disease duration since symptom onset, baseline HHD overall megascore, and use of riluzole/edaravone. Missing data were handled using multiple imputation.|ANCOVA|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.||||0.255|-0.207|= 0.8390
74046910|NCT03787095|147646078|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||0.71
74096786|NCT03433755|147742727|SUPERIORITY||Treatment difference|-70.73|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-77.98|-63.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-63.48|-77.98|< 0.0001
74046911|NCT03787095|147646079|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||1.00
74046912|NCT03787095|147646080|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||0.33
74046913|NCT02092324|147646083|SUPERIORITY|1-proportion test for greater than 10% difference.||||||0.002||||||p-value for Protocol-defined objective response|binomial|||Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate (based on Simon's 2-stage).||||0.002
74046914|NCT02092324|147646083|SUPERIORITY|1-proportion test for greater than 10% difference||||||0.9||||||p-value is for IWG-defined objective response|binomial|||Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate (based on Simon's 2-stage).||||0.90
74046915|NCT02092324|147646086|SUPERIORITY|Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate.|||||<|0.0001||||||p-value for protocol-defined objective response. p-value for IWG-defined objective response is 0.70|Clopper-Pearson method|||||||<0.0001
74046916|NCT02092324|147646086|SUPERIORITY|Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate.||||||0.7||||||p-value for IWG-defined objective response|Clopper-Pearson method|||||||0.70
74046917|NCT02092324|147646096|EQUIVALENCE|2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic)||||||0.003||||||p-value for protocol-defined objective response.|Chi-squared, Corrected|||2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic) comparing Wildtype and Mutant CSF3R status for protocol-defined objective response||||0.003
74046918|NCT02092324|147646096|EQUIVALENCE|2-sample test for equality of proportions with continuity correction (Pearson's chi-square)||||||0.1||||||p-value for IWG-defined objective response = 0.1|Fisher Exact|||2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic) comparing Wildtype and Mutant CSF3R status for IWG-defined objective response||||0.1
74046919|NCT00441012|147646106|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|100.0||||||95.0|98.7|100.0|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.||100.0|98.7|
74046920|NCT00441012|147646106|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|99.1||||||95.0|69.9|99.9|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.||99.9|69.9|
74046921|NCT00441012|147646107|NON_INFERIORITY_OR_EQUIVALENCE|The Modified Process Vaccine is non-inferior to COMVAX with respect to anti-HBs GMT. The non-inferiority criterion requires that the lower bound of the two-sided 95% confidence interval on the ratio of the Month 11 GMTs \[GMT modified process vaccine/GMT COMVAX™\] is \>0.67.|Geometric Mean Titer Ratio|2.5||||||95.0|1.9|3.3||||||||3.3|1.9|
74046922|NCT00441012|147646109|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|93.9||||||95.0|90.0|96.6|||||Exact binomial confidence interval|||96.6|90.0|
74046923|NCT00441012|147646109|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|92.1||||||95.0|87.8|95.3|||||Exact binomial confidence interval|No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of participants with anti-PRP \> 1µg/mL) in each group at 1 month after the third dose.||95.3|87.8|
74046924|NCT01838304|147646113|OTHER||Odds Ratio (OR)|7.9|||<|0.0001|TWO_SIDED|95.0|4.21|14.81|||Fisher Exact|||Fisher's exact test for odd's ratio of time below a saturation of 80% to total time||14.81|4.21|<0.0001
74046925|NCT03674541|147646115|SUPERIORITY|||||||0.043|||||||Welch's t-test|||||||0.043
74046926|NCT03674541|147646116|SUPERIORITY|||||||0.008||||||P-value was not adjusted for multiplicity for secondary outcomes|Welch's t-test|||||||0.008
74046927|NCT03674541|147646117|SUPERIORITY|||||||0.263||||||Not adjusted for multiplicity|Welch's t-test|||||||0.263
74046928|NCT03674541|147646118|SUPERIORITY|||||||0.039||||||Not adjusted for multiplicity|Welch's t-test|||||||0.039
74046929|NCT03674541|147646119|SUPERIORITY|||||||0.068||||||Not adjusted for multiplicity|Welch's t-test|||||||0.068
74046930|NCT03674541|147646120|SUPERIORITY|||||||0.045||||||Not adjusted for multiplicity|Welch's t-test|||||||0.045
74046931|NCT03674541|147646121|SUPERIORITY|||||||1||||||Not adjusted multiplicity|Welch's t-test|||||||1.000
74046932|NCT03674541|147646122|SUPERIORITY|||||||0.093||||||Not adjusted for multiplicity|Welch's t-test|||||||0.093
74046933|NCT03674541|147646123|SUPERIORITY|||||||0.427||||||Not adjusted for multiplicity|Welch's t-test|||||||0.427
74046934|NCT03674541|147646124|SUPERIORITY|||||||0.262||||||Not adjusted for multiplicity|Welch's t-test|||||||0.262
74046935|NCT03674541|147646125|SUPERIORITY|||||||0.038||||||Not adjusted for multiplicity|Welch's t-test|||||||0.038
74046936|NCT03674541|147646126|SUPERIORITY|||||||0.147|||||||Welch's t-test|||||||0.147
74046937|NCT00117572|147646178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.68|TWO_SIDED|95.0|0.59|1.41|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|Comparison of overall survival curves||1.41|0.59|0.68
74046938|NCT00117572|147646179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.37|TWO_SIDED|95.0|0.55|1.25|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|||1.25|0.55|0.37
74046939|NCT00117572|147646180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.16|TWO_SIDED|95.0|0.51|1.12|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|||1.12|0.51|0.16
74046940|NCT00117572|147646181|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher Exact|||||||0.57
74046941|NCT00117572|147646182|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
73880755|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|7.55||||0.0001|TWO_SIDED|95.0|2.66|21.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||21.45|2.66|0.0001
73880756|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|6.41||||0.0005|TWO_SIDED|95.0|2.25|18.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.26|2.25|0.0005
74046942|NCT00117572|147646183|SUPERIORITY_OR_OTHER|||||||0.55|||||||t-test, 2 sided|Comparison of change scores between treatment groups||||||0.55
74046943|NCT00117572|147646184|SUPERIORITY_OR_OTHER|||||||0.034|||||||t-test, 2 sided|||||||0.034
74046944|NCT00117572|147646185|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
74046945|NCT00117572|147646186|SUPERIORITY_OR_OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
74046946|NCT00117572|147646187|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
74046947|NCT00117572|147646188|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
74046948|NCT00117572|147646189|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
74046949|NCT00117572|147646190|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.090
74046950|NCT01387594|147646194|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|1.33|||||TWO_SIDED|80.0|1.13|1.56||A p-value was not computed; hypothesis was tested using confidence interval (CI) approach.|||The lower limit of 80% CI greater than 0.5 indicates the statistical significance at alpha=0.1 level.|The null hypothesis is the (median) percent decrease in total lymphocytes count is greater or equal to 50%, equivalently indicating that the geometric mean ratio (GMR: post-treatment/pretreatment) in total lymphocyte counts is less than or equal to 0.5.||1.56|1.13|
74046951|NCT05849441|147646200|SUPERIORITY|||||||0.04||||||This is for the subscale: Support-Seeking.|Regression, Linear|||||||0.04
74046952|NCT05849441|147646200|SUPERIORITY|||||||0.02||||||This is for subscale: Problem Solving|Regression, Linear|||||||0.02
74046953|NCT05849441|147646200|SUPERIORITY|||||||0.55||||||This is for subscale: Distancing|Regression, Linear|||||||0.55
74046954|NCT05849441|147646200|SUPERIORITY|||||||0.79||||||This is for subscale: Internalizing|Regression, Linear|||||||0.79
74046955|NCT05849441|147646200|SUPERIORITY|||||||0.93||||||This is for subscale: Externalizing|Regression, Linear|||||||0.93
74046956|NCT05849441|147646200|SUPERIORITY|||||||0.09||||||This is for subscale: Mindfulness|Regression, Linear|||||||0.09
74046957|NCT05849441|147646201|SUPERIORITY|||||||0.32||||||This is for subscale: Reappraisal|Regression, Linear|||||||0.32
74046958|NCT05849441|147646201|SUPERIORITY|||||||0.24||||||This is for subscale: Suppression|Regression, Linear|||||||0.24
74046959|NCT05849441|147646202|SUPERIORITY|||||||0.53||||||This is for subscale: Manage own emotions|Regression, Linear|||||||0.53
74046960|NCT05849441|147646202|SUPERIORITY|||||||0.16||||||This is for subscale: Identify and Understand Own Emotions|Regression, Linear|||||||0.16
74046961|NCT05849441|147646202|SUPERIORITY|||||||0.27||||||This is for subscale: Deal with emotions of others|Regression, Linear|||||||0.27
74046962|NCT05849441|147646202|SUPERIORITY|||||||0.59||||||This is for subscale: Perceive emotions through faces and bodies|Regression, Linear|||||||0.59
74046963|NCT05849441|147646203|SUPERIORITY|||||||0.16|||||||Regression, Linear|||||||0.16
74046964|NCT05849441|147646204|SUPERIORITY|||||||0.65||||||This is for subscale: Fear of Negative Evaluation|Regression, Linear|||||||0.65
74046965|NCT05849441|147646204|SUPERIORITY|||||||0.6||||||This is for subscale: Social avoidance and distress (new)|Regression, Linear|||||||0.60
74046966|NCT05849441|147646204|SUPERIORITY|||||||0.23||||||This is for subscale: social avoidance and distress (general)|Regression, Linear|||||||0.23
74046967|NCT05849441|147646205|SUPERIORITY|||||||0.55|||||||Regression, Linear|||||||0.55
74046968|NCT05849441|147646206|SUPERIORITY|||||||0.11||||||This is for subscale: Negativity|Regression, Linear|||||||0.11
74046969|NCT05849441|147646206|SUPERIORITY|||||||0.79||||||This is for subscale: Emotion regulation|Regression, Linear|||||||0.79
74046970|NCT05849441|147646207|SUPERIORITY|||||||0.14||||||This is for subscale: Working Memory|Regression, Linear|||||||0.14
74046971|NCT05849441|147646207|SUPERIORITY|||||||0.2||||||This is for subscale: Planning|Regression, Linear|||||||0.20
74046972|NCT05849441|147646207|SUPERIORITY|||||||0.48||||||This is for subscale: Inhibit|Regression, Linear|||||||0.48
74046973|NCT05849441|147646207|SUPERIORITY|||||||0.37||||||This is for subscale: Regulation|Regression, Linear|||||||0.37
74046974|NCT05849441|147646208|SUPERIORITY|||||||0.45|||||||Regression, Linear|||||||0.45
74046975|NCT05849441|147646209|SUPERIORITY|||||||0.88|||||||Regression, Linear|||||||0.88
74046976|NCT03277794|147646210|OTHER||Odds Ratio (OR)|2.28|STANDARD_ERROR_OF_MEAN|0.89||0.354|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.354
74046977|NCT03277794|147646210|OTHER||Odds Ratio (OR)|2.01|STANDARD_ERROR_OF_MEAN|0.95||0.465|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.465
74046978|NCT03277794|147646211|OTHER||Odds Ratio (OR)|2.31|STANDARD_ERROR_OF_MEAN|0.59||0.159|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.159
74046979|NCT03277794|147646211|OTHER||Odds Ratio (OR)|2.3|STANDARD_ERROR_OF_MEAN|0.64||0.2|TWO_SIDED||||||Regression, Linear|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.200
74046980|NCT03277794|147646212|OTHER||Odds Ratio (OR)|3.18|STANDARD_ERROR_OF_MEAN|0.74||0.121|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.121
74046981|NCT03277794|147646212|OTHER||Odds Ratio (OR)|3.63|STANDARD_ERROR_OF_MEAN|0.85||0.134|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.134
74046982|NCT03277794|147646213|OTHER|||||||0.899||||||Unadjusted.|Regression, Linear|||||||0.899
74046983|NCT03277794|147646213|OTHER|||||||0.128||||||Unadjusted|Regression, Linear|||||||0.128
74046984|NCT03277794|147646214|OTHER|||||||0.198||||||Unadjusted.|Regression, Linear|||||||0.198
74046985|NCT03277794|147646214|OTHER|||||||0.017||||||Unadjusted.|Regression, Linear|||||||0.017
74046986|NCT03277794|147646215|OTHER|||||||0.091||||||Unadjusted.|Regression, Linear|||||||0.091
74046987|NCT03277794|147646215|OTHER|||||||0.591||||||Unadjusted.|Regression, Linear|||||||0.591
74046988|NCT03277794|147646216|OTHER|||||||0.03||||||Unadjusted.|Regression, Linear|||||||0.030
74046989|NCT03277794|147646216|OTHER|||||||0.005||||||Unadjusted.|Regression, Linear|||||||0.005
74046990|NCT03277794|147646217|OTHER|||||||0.163||||||Unadjusted.|Regression, Linear|||||||0.163
74046991|NCT03277794|147646217|OTHER|||||||0.865||||||Unadjusted.|Regression, Linear|||||||0.865
74046992|NCT03277794|147646218|OTHER|||||||0.98||||||Unadjusted.|Regression, Linear|||||||0.980
74046993|NCT03277794|147646218|OTHER|||||||0.758||||||Unadjusted.|Regression, Linear|||||||0.758
73888083|NCT01746901|147309535|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.5513|TWO_SIDED|95.0|-7.8|14.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.6|-7.8|0.5513
74046994|NCT03277794|147646219|OTHER|||||||0.124||||||Unadjusted.|Regression, Linear|||||||0.124
74046995|NCT03277794|147646219|OTHER|||||||0.168||||||Unadjusted.|Regression, Linear|||||||0.168
74046996|NCT03277794|147646220|OTHER|||||||0.436||||||Unadjusted.|Regression, Linear|||||||0.436
74046997|NCT03277794|147646220|OTHER|||||||0.706||||||Unadjusted.|Regression, Linear|||||||0.706
74046998|NCT03277794|147646221|OTHER|||||||0.604||||||Unadjusted.|Regression, Linear|||Internalizing||||0.604
74046999|NCT03277794|147646221|OTHER|||||||0.177||||||Unadjusted.|Regression, Linear|||Internalizing||||0.177
74047000|NCT03277794|147646221|OTHER|||||||0.325||||||Unadjusted.|Regression, Linear|||Externalizing||||0.325
74047001|NCT03277794|147646221|OTHER|||||||0.227||||||Unadjusted.|Regression, Linear|||Externalizing||||0.227
74047002|NCT03277794|147646221|OTHER|||||||0.106||||||Unadjusted.|Regression, Linear|||Substance Use||||0.106
74047003|NCT03277794|147646221|OTHER|||||||0.058||||||Unadjusted.|Regression, Linear|||Substance Use||||0.058
74047004|NCT03277794|147646222|OTHER|||||||0.862||||||Unadjusted.|Regression, Linear|||Emotional Supports||||0.862
74047005|NCT03277794|147646222|OTHER|||||||0.382||||||Unadjusted.|Regression, Linear|||Emotional Supports||||0.382
74047006|NCT03277794|147646222|OTHER|||||||0.68||||||Unadjusted.|Regression, Linear|||Tangible Supports||||0.680
74047007|NCT03277794|147646222|OTHER|||||||0.988||||||Unadjusted.|Regression, Linear|||Tangible Supports||||0.988
74047008|NCT03277794|147646222|OTHER|||||||0.701||||||Unadjusted.|Regression, Linear|||Affectionate||||0.701
74047009|NCT03277794|147646222|OTHER|||||||0.154||||||Unadjusted.|Regression, Linear|||Affectionate||||0.154
74047010|NCT03277794|147646223|OTHER|||||||0.719||||||Unadjusted.|Regression, Linear|||Physical Health||||0.719
74047011|NCT03277794|147646223|OTHER|||||||0.15||||||Unadjusted.|Regression, Linear|||Physical Health||||0.150
74047012|NCT03277794|147646223|OTHER|||||||0.789||||||Unadjusted.|Regression, Linear|||Psychological||||0.789
74047013|NCT03277794|147646223|OTHER|||||||0.811||||||Unadjusted.|Regression, Linear|||Psychological||||0.811
74047014|NCT03277794|147646223|OTHER|||||||0.726||||||Unadjusted.|Regression, Linear|||Social||||0.726
74047015|NCT03277794|147646223|OTHER|||||||0.795||||||Unadjusted.|Regression, Linear|||Social||||0.795
74047016|NCT03277794|147646223|OTHER|||||||0.837||||||Unadjusted.|Regression, Linear|||Environment||||0.837
74047017|NCT03277794|147646223|OTHER|||||||0.048||||||Unadjusted.|Regression, Linear|||Environment||||0.048
74047018|NCT03991468|147646239|NON_INFERIORITY|A Mixed Model Repeated Measures logistic regression was used to prove WSI major discordance (MD) rate non-inferior to Glass MD rate. A two-sided 95% CI for the difference in MD rate was constructed. If the upper bound of the 95% CI was less than the non-inferiority margin of 4%, then WSI would be considered non-inferior to Glass, assuming power = 0.9 and alpha = 0.05 a sample size of 2000 was calculated to be sufficient to prove non-inferiority.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis|Dependent var = major discordance status (yes/no); independent var = modality (WSI/Glass) as a fixed effect \& site, reader, \& case as random effects.||||1.0|-0.1|
74047019|NCT04507360|147646275|SUPERIORITY||Mean Difference (Final Values)|0.23|||||TWO_SIDED|||||||||"Mean difference in Overall row"||||
74047020|NCT04507360|147646277|SUPERIORITY||Mean Difference (Final Values)|0.96|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
74047021|NCT04507360|147646277|SUPERIORITY||Mean Difference (Final Values)|0.63|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
74047022|NCT04507360|147646277|SUPERIORITY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
74047023|NCT04507360|147646277|SUPERIORITY||Mean Difference (Final Values)|0.62|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
74047024|NCT04507360|147646277|SUPERIORITY||Mean Difference (Final Values)|0.85|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
74047025|NCT04507360|147646277|SUPERIORITY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
74047026|NCT04507360|147646277|SUPERIORITY||Mean Difference (Final Values)|1.39|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
74047027|NCT04507360|147646277|SUPERIORITY||Mean Difference (Final Values)|2.16|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
74047028|NCT04507360|147646277|SUPERIORITY||Mean Difference (Final Values)|2.69|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
73880757|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0695|TWO_SIDED|95.0|0.93|6.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.02|0.93|0.0695
73880758|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|4.83||||0.0015|TWO_SIDED|95.0|1.83|12.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.77|1.83|0.0015
74047029|NCT04507360|147646277|SUPERIORITY||Mean Difference (Final Values)|1.75|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
74047030|NCT04507360|147646278|SUPERIORITY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
74047031|NCT04507360|147646278|SUPERIORITY||Mean Difference (Final Values)|0.42|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
74047032|NCT04507360|147646278|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
73880759|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.28||||0.012|TWO_SIDED|95.0|1.3|8.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.28|1.30|0.0120
74047033|NCT04507360|147646278|SUPERIORITY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
74047034|NCT04507360|147646279|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
74047035|NCT04507360|147646279|SUPERIORITY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
74047036|NCT04507360|147646279|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
74047037|NCT04507360|147646279|SUPERIORITY||Mean Difference (Final Values)|0.29|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
74047038|NCT04507360|147646280|SUPERIORITY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
74047039|NCT04507360|147646280|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
74047040|NCT04507360|147646280|SUPERIORITY||Mean Difference (Final Values)|1.24|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
74047041|NCT04507360|147646280|SUPERIORITY||Mean Difference (Final Values)|0.47|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
74047042|NCT04507360|147646280|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
74047043|NCT04507360|147646280|SUPERIORITY||Mean Difference (Final Values)|1.98|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
74047044|NCT04507360|147646280|SUPERIORITY||Mean Difference (Final Values)|1.18|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
74047045|NCT04507360|147646280|SUPERIORITY||Mean Difference (Final Values)|3.67|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
74047046|NCT04507360|147646280|SUPERIORITY||Mean Difference (Final Values)|4.22|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
74047047|NCT04507360|147646280|SUPERIORITY||Mean Difference (Final Values)|2.07|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
74047048|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|||||||||Mean difference at baseline||||
74047049|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|0.29|||||TWO_SIDED|||||||||Mean difference at week 1||||
74047050|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|||||||||Mean difference at week 2||||
74047051|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|0.13|||||TWO_SIDED|||||||||Mean difference at week 3||||
74047052|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|1.68|||||TWO_SIDED|||||||||Mean difference at week 4||||
74047053|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|||||||||Mean difference at week 8||||
74047054|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|0.28|||||TWO_SIDED|||||||||Mean difference at baseline||||
74047055|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|0.67|||||TWO_SIDED|||||||||Mean difference at week 1||||
74047056|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|0.78|||||TWO_SIDED|||||||||Mean difference at week 2||||
74047057|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|||||||||Mean difference at week 3||||
74047058|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|0.47|||||TWO_SIDED|||||||||Mean difference at week 4||||
74047059|NCT04507360|147646283|SUPERIORITY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|||||||||Mean difference at week 8||||
74047060|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|||||||||Mean difference at baseline||||
74047061|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|||||||||Mean difference at week 1||||
74047062|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|0.23|||||TWO_SIDED|||||||||Mean difference at week 2||||
74047063|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|||||||||Mean difference at week 3||||
74047064|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|1.26|||||TWO_SIDED|||||||||Mean difference at week 4||||
74047065|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|||||||||Mean difference at week 8||||
74047066|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED|||||||||Mean difference at baseline||||
74047067|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|||||||||Mean difference at week 1||||
74047068|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|||||||||Mean difference at week 2||||
74047069|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|||||||||Mean difference at week 3||||
74047070|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|||||||||Mean difference at week 4||||
74047071|NCT04507360|147646284|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|||||||||Mean difference at week 8||||
74047072|NCT04058990|147646287|NON_INFERIORITY|13.2% non-inferiority margin||||||0.0012|||||||Farrington-Manning|||\[Not Specified\]||||0.0012
74096787|NCT03433755|147742727|SUPERIORITY||Treatment difference|-69.74|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-76.51|-62.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-62.97|-76.51|< 0.0001
74096788|NCT03433755|147742728|SUPERIORITY||Treatment difference|-70.87|STANDARD_ERROR_OF_MEAN|4.33|<|0.0001|TWO_SIDED|95.0|-79.47|-62.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-62.27|-79.47|< 0.0001
74096789|NCT03433755|147742728|SUPERIORITY||Treatment difference|-65.81|STANDARD_ERROR_OF_MEAN|4.11|<|0.0001|TWO_SIDED|95.0|-73.97|-57.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-57.66|-73.97|< 0.0001
74047073|NCT03050307|147646289|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-3.7|||||TWO_SIDED|95.0|-10.966|3.339||||||||3.339|-10.966|
74096790|NCT03433755|147742729|SUPERIORITY||Treatment difference|-76.5|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|95.0|-86.6|-66.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-66.4|-86.6|< 0.0001
74047074|NCT03050307|147646290|NON_INFERIORITY|If the primary outcome measure was met, then the hypothesis for this outcome measure was that if the lower bound of the 95% CI of the difference was ≥-10%, noninferiority for TAK-438 relative to lansoprazole with regard to H pylori eradication was declared.|Exact (Clopper-Pearson)|7.2|||||TWO_SIDED|95.0|-4.469|18.825||||||||18.825|-4.469|
74047075|NCT03050307|147646291|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-6.0|||||TWO_SIDED|95.0|-16.644|4.741||||||||4.741|-16.644|
74047076|NCT03050307|147646292|OTHER|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-1.1|||||TWO_SIDED|95.0|-25.175|23.07||||||Epigastric Pain (Postprandial)||23.070|-25.175|
74047077|NCT03050307|147646292|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|4.5|||||TWO_SIDED|95.0|-11.907|20.931||||||Epigastric Pain (Fasting/Nocturnal)||20.931|-11.907|
74096791|NCT03433755|147742729|SUPERIORITY||Treatment difference|-77.2|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001|TWO_SIDED|95.0|-87.7|-66.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-66.7|-87.7|< 0.0001
74096792|NCT03433755|147742730|SUPERIORITY||Treatment difference|-75.9|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-87.1|-64.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-64.7|-87.1|< 0.0001
74096793|NCT03433755|147742730|SUPERIORITY||Treatment difference|-73.0|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-84.1|-61.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-61.8|-84.1|< 0.0001
74096794|NCT03433755|147742731|SUPERIORITY||Treatment difference|-61.2|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|95.0|-68.04|-54.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-54.37|-68.04|< 0.0001
74096795|NCT03433755|147742731|SUPERIORITY||Treatment difference|-62.15|STANDARD_ERROR_OF_MEAN|2.94|<|0.0001|TWO_SIDED|95.0|-67.97|-56.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-56.32|-67.97|< 0.0001
74047078|NCT03050307|147646292|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|16.0|||||TWO_SIDED|95.0|-11.255|43.321||||||Abdominal Bloating||43.321|-11.255|
74047079|NCT03050307|147646292|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|10.1|||||TWO_SIDED|95.0|-5.109|25.348||||||Heartburn||25.348|-5.109|
74047080|NCT03050307|147646292|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-12.2|||||TWO_SIDED|95.0|-45.138|20.694||||||Lack of Appetite||20.694|-45.138|
74047081|NCT01998906|147646303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6||||0.0051|TWO_SIDED|95.0|5.0|30.2|||Chi-squared|||||30.2|5.0|0.0051
74047082|NCT01998906|147646304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3||||0.0014|TWO_SIDED|95.0|7.2|31.4|||Chi-squared|||||31.4|7.2|0.0014
74047083|NCT01998906|147646305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.3077|TWO_SIDED|95.0|-6.4|19.1|||Chi-squared|||||19.1|-6.4|0.3077
74047084|NCT01998906|147646307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0275|TWO_SIDED|95.0|0.44|0.96|||Log Rank|||||0.96|0.44|0.0275
73880760|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.49||||0.662|TWO_SIDED|95.0|0.94|6.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.57|0.94|0.662
74047085|NCT01998906|147646309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.0555|TWO_SIDED|95.0|0.35|1.02|||Log Rank|||||1.02|0.35|0.0555
74047086|NCT05724069|147646315|SUPERIORITY||Median Difference (Net)|-0.239|||=|0.1279|TWO_SIDED|95.0|-0.553|0.074|||paired T-test|||Subjects in this analysis are 15 and not 30 (this happens because arms are not mutually exclusive, as explained in previous sections). Each subject can contribute with 0, 1, 2 pairs. Only data that constitute pairs evaluable for primary endpoint are considered in the analysis; the pairs evaluable for primary endpoint were 23.||0.074|-0.553|=0.1279
74047087|NCT03552289|147646316|SUPERIORITY|||||||0.8283|||||||One-sided Z-test|||||||0.8283
74047088|NCT01077193|147646337|NON_INFERIORITY_OR_EQUIVALENCE|See above.|Mean Percent Excess Weight Loss|37.9|STANDARD_DEVIATION|25.18||0.3227|TWO_SIDED|95.0|30.2|45.5||No multiple comparison adjustments are necessary as this is a single hypothesis on 1 parameter for a within group change comparison to 36.1%.|t-test, 1 sided|||A sample size of 32 achieves power\>90% to demonstrate non-inferiority using a one-sided t-test (alpha=0.025) when the margin of equivalence is a 5% difference in EWL. The true difference between %EWL for patients undergoing a greater curvature procedure and the target %EWL is hypothesized to be 0. The target %EWL at 3 years is 41.1%, based upon prior studies. This power analysis assumes data are drawn from a single population with a standard deviation of 8.20.||45.5|30.2|0.3227
74047089|NCT00762528|147646370|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
74047090|NCT00762528|147646371|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
74047091|NCT00762528|147646372|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
74047092|NCT00762528|147646373|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
74047093|NCT00762528|147646374|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
74047094|NCT00762528|147646375|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
74047095|NCT00762528|147646376|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
74047096|NCT00762528|147646377|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
74047097|NCT01536418|147646383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|||||TWO_SIDED|95.0|-3.0|19.3||||||||19.3|-3.0|
74047098|NCT01536418|147646384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-5.8|10.8||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 8||10.8|-5.8|
74047099|NCT01536418|147646384|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.6|||||TWO_SIDED|95.0|-3.0|14.3||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 12||14.3|-3.0|
74047100|NCT01536418|147646384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-4.6|9.5||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at both Weeks 8 and 12||9.5|-4.6|
74047101|NCT01536418|147646385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||||TWO_SIDED|95.0|-6.0|15.9||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at Week 8||15.9|-6.0|
74047102|NCT01536418|147646385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-1.0|18.7||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at both Week 8 and Week 12||18.7|-1.0|
74047103|NCT03342404|147646392|SUPERIORITY||Difference in proportions|77.1|||||TWO_SIDED|95.0|63.4|87.0|||||The difference in proportions (luspatercept - placebo) and 95% CI were estimated from the exact unconditional test|||87.0|63.4|
74047104|NCT03342404|147646392|SUPERIORITY||Risk Difference (RD)|77.1|||||TWO_SIDED|95.0|68.7|85.5|||||The common risk difference (luspatercept - placebo) and 95% CI were estimated from the CMH test stratified by baseline Hb category and baseline NTDT-PRO T/W domain score category|||85.5|68.7|
73888084|NCT01746901|147309535|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0469|TWO_SIDED|95.0|0.2|22.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.8|0.2|0.0469
74047105|NCT03342404|147646393|SUPERIORITY||Mean Difference (Net)|-0.48||||0.0924|TWO_SIDED|95.0|-1.03|0.08|||ANCOVA|||||0.08|-1.03|0.0924
74047106|NCT03342404|147646394|SUPERIORITY||Mean Difference (Net)|1.42|||<|0.0001|TWO_SIDED|95.0|1.16|1.67|||ANCOVA|||||1.67|1.16|< 0.0001
74047107|NCT03342404|147646395|SUPERIORITY||Mean Difference (Net)|68.8|||<|0.0001|TWO_SIDED|95.0|54.3|80.4|||Cochran-Mantel-Haenszel|||||80.4|54.3|< 0.0001
74047108|NCT03342404|147646396|SUPERIORITY||Mean Difference (Net)|1.39||||0.2641|TWO_SIDED|95.0|-1.06|3.83|||ANCOVA|||||3.83|-1.06|0.2641
74047109|NCT03342404|147646397|SUPERIORITY||Mean Difference (Net)|-0.49||||0.0721|TWO_SIDED|95.0|-1.02|0.04|||ANCOVA|||||0.04|-1.02|0.0721
74047110|NCT03342404|147646398|SUPERIORITY||Mean Difference (Net)|1.49|||<|0.0001|TWO_SIDED|95.0|1.2|1.79|||ANCOVA|||||1.79|1.20|< 0.0001
74047111|NCT03342404|147646399|SUPERIORITY||Mean Difference (Net)|2.19||||0.0959|TWO_SIDED|95.0|-0.39|4.78|||ANCOVA|||||4.78|-0.39|0.0959
74047112|NCT03342404|147646400|SUPERIORITY||Mean Difference (Net)|-0.79||||0.051|TWO_SIDED|95.0|-1.58|0.0|||ANCOVA|||||0.00|-1.58|0.0510
74047113|NCT03342404|147646401|SUPERIORITY||Mean Difference (Net)|-1.07||||0.0047|TWO_SIDED|95.0|-1.8|-0.33|||ANCOVA|||||-0.33|-1.80|0.0047
74047114|NCT03342404|147646402|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1359|TWO_SIDED|95.0|0.8|4.0|||Cochran-Mantel-Haenszel|||||4.0|0.8|0.1359
74047115|NCT03342404|147646403|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0657|TWO_SIDED|95.0|0.9|5.4|||Cochran-Mantel-Haenszel|||||5.4|0.9|0.0657
74047116|NCT03342404|147646404|SUPERIORITY||Mean Difference (Net)|1.39||||0.0847|TWO_SIDED|95.0|-0.19|2.96|||Mixed Models Analysis|||Mean change from baseline in SF-36 PCS to Week 24||2.96|-0.19|0.0847
74047117|NCT03342404|147646404|SUPERIORITY||Mean Difference (Net)|1.75||||0.0712|TWO_SIDED|95.0|-0.15|3.65|||Mixed Models Analysis|||Mean change from baseline in SF-36 PCS to Week 48||3.65|-0.15|0.0712
74047118|NCT03342404|147646404|SUPERIORITY||Mean Difference (Net)|1.54||||0.1633|TWO_SIDED|95.0|-0.63|3.72|||Mixed Models Analysis|||Mean change from baseline in SF-36 MCS to Week 24||3.72|-0.63|0.1633
74047119|NCT03342404|147646404|SUPERIORITY||Mean Difference (Net)|2.7||||0.0469|TWO_SIDED|95.0|0.04|5.36|||Mixed Models Analysis|||Mean change from baseline in SF-36 MCS to Week 48||5.36|0.04|0.0469
74047120|NCT03342404|147646405|SUPERIORITY||Mean Difference (Net)|-4.2||||0.4787|TWO_SIDED|95.0|-21.4|13.0|||Cochran-Mantel-Haenszel|||Percentage of participants with improvement of iron overload (LIC/ICT responders) at Week 24||13.0|-21.4|0.4787
74047121|NCT03342404|147646405|SUPERIORITY||Mean Difference (Net)|-14.6||||0.0827|TWO_SIDED|95.0|-31.5|2.4|||Cochran-Mantel-Haenszel|||Percentage of participants with improvement of iron overload (LIC/ICT responders) at Week 48||2.4|-31.5|0.0827
74047122|NCT03342404|147646406|SUPERIORITY||Mean Difference (Net)|27.14||||0.5949|TWO_SIDED|95.0|-46.77|101.06|||ANCOVA|||Mean change from baseline in serum ferritin at Week 24||101.06|-46.77|0.5949
74047123|NCT03342404|147646406|SUPERIORITY||Mean Difference (Net)|13.46||||0.3454|TWO_SIDED|95.0|-61.01|87.93|||ANCOVA|||Mean change from baseline in serum ferritin at Week 48||87.93|-61.01|0.3454
74047124|NCT03342404|147646407|SUPERIORITY||Mean Difference (Net)|-0.09||||0.6628|TWO_SIDED|95.0|-0.47|0.3|||ANCOVA|||Mean change from baseline in LIC at Week 24||0.30|-0.47|0.6628
74047125|NCT03342404|147646407|SUPERIORITY||Mean Difference (Net)|0.66||||0.0859|TWO_SIDED|95.0|-0.09|1.42|||ANCOVA|||Mean change from baseline in LIC at Week 48||1.42|-0.09|0.0859
74047126|NCT03342404|147646408|SUPERIORITY||Mean Difference (Net)|22.2||||0.0013|TWO_SIDED|95.0|5.0|38.6|||Cochran-Mantel-Haenszel|||Percentage of participants who were transfusion free over 24 weeks||38.6|5.0|0.0013
74047127|NCT03342404|147646409|SUPERIORITY||Mean Difference (Net)|37.4|||<|0.0001|TWO_SIDED|95.0|20.9|53.0|||Cochran-Mantel-Haenszel|||Percentage of Participants Who are Transfusion-Free Over 48 Weeks||53.0|20.9|< 0.0001
74047128|NCT03342404|147646411|SUPERIORITY||Mean Difference (Net)|16.15||||0.1466|TWO_SIDED|95.0|-5.73|38.04|||ANCOVA|||Mean change from baseline in 6MWT distance at Week 24||38.04|-5.73|0.1466
74047129|NCT03342404|147646411|SUPERIORITY||Mean Difference (Net)|12.44||||0.2011|TWO_SIDED|95.0|-6.72|31.59|||ANCOVA|||Mean change from baseline in 6MWT distance at Week 48||31.59|-6.72|0.2011
74047130|NCT03342404|147646412|SUPERIORITY||Mean Difference (Net)|52.1|||<|0.0001|TWO_SIDED|95.0|36.2|66.2|||Cochran-Mantel-Haenszel|||Percentage of Participants with an Increase From Baseline ≥1.5 g/dL in Mean Hemoglobin Values in the Absence of Transfusion||66.2|36.2|< 0.0001
74047131|NCT03342404|147646413|SUPERIORITY||Mean Difference (Net)|1.7||||0.1989|TWO_SIDED|95.0|0.8|3.7|||Cochran-Mantel-Haenszel|||Percentage of Participants With a Decrease From Baseline ≥ RD (= 1) in the Non-Transfusion Dependent β-thalassemia-Patient Reported Outcome (NTDT-PRO) Tiredness and Weakness (T/W) Domain Score Week 13 to Week 24||3.7|0.8|0.1989
74047132|NCT03342404|147646413|SUPERIORITY||Mean Difference (Net)|2.1||||0.0733|TWO_SIDED|95.0|0.9|5.0|||Cochran-Mantel-Haenszel|||Percentage of Participants With a Decrease From Baseline ≥ RD (= 1) in the Non-Transfusion Dependent β-thalassemia-Patient Reported Outcome (NTDT-PRO) Tiredness and Weakness (T/W) Domain Score Week 37 to Week 48||5.0|0.9|0.0733
74047133|NCT01957085|147646424|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.04||||||Statistical significance was set at .05 to determine statistical significance.|Chi-squared|||||||=.04
74047134|NCT01957085|147646425|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
74047135|NCT01957085|147646426|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
74047136|NCT01957085|147646428|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
74047137|NCT03748420|147646429|SUPERIORITY||Odds Ratio (OR)|1.29|STANDARD_ERROR_OF_MEAN|0.09845||0.0103|TWO_SIDED|95.0|1.06|1.56|||Regression, Logistic|||||1.56|1.06|0.0103
74047138|NCT03748420|147646430|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.1166||0.7967|TWO_SIDED|95.0|0.82|1.3|||Regression, Logistic|||||1.30|0.82|0.7967
74047139|NCT03748420|147646431|SUPERIORITY||Odds Ratio (OR)|1.18|STANDARD_ERROR_OF_MEAN|0.08906||0.0589|TWO_SIDED|95.0|0.99|1.41|||Regression, Logistic|||||1.41|0.99|0.0589
74047140|NCT03748420|147646432|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.0871||0.21|TWO_SIDED|95.0|-0.8|3.5|||Mixed Models Analysis|||||3.5|-0.8|0.21
74047141|NCT03748420|147646433|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1234||0.2|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|0.20
74047142|NCT03748420|147646434|SUPERIORITY||Mean Difference (Net)|-7.47|STANDARD_ERROR_OF_MEAN|59.96||0.901|TWO_SIDED|95.0|-124.99|110.04|||Mixed Models Analysis|||||110.04|-124.99|0.901
74047143|NCT01899768|147646439|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.26|||||TWO_SIDED|90.0|1.1|1.44|||||Ratio of adjusted geometric means = GSK2339345/Placebo.|||1.44|1.10|
74047144|NCT01899768|147646440|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.02|||||TWO_SIDED|90.0|0.87|1.19|||||Ratio of adjusted geometric means = GSK2339345/Placebo.|||1.19|0.87|
74047145|NCT01899768|147646463|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.23|||||TWO_SIDED|90.0|0.86|1.75|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.|||1.75|0.86|
74047146|NCT01899768|147646463|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.36|||||TWO_SIDED|90.0|1.07|1.72|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 4-8 hr.|||1.72|1.07|
74047147|NCT01899768|147646464|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.97|||||TWO_SIDED|90.0|0.67|1.4|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.|||1.40|0.67|
73880761|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1019|TWO_SIDED|95.0|0.85|5.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.80|0.85|0.1019
74047148|NCT01899768|147646464|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means = GSK2|1.04|||||TWO_SIDED|90.0|0.79|1.36|||Ratio of adjusted geometric mean|||||1.36|0.79|
74047149|NCT03236506|147646490|NON_INFERIORITY|Assuming a 95% SVR rate (based on published studies) in the DOT arm of the trial in this population and a non-inferiority limit of 14% (which would be likely to maintain cost-effectiveness) then at a 5% significance level and 90% power we would need a sample size of 42 in each group 126 in total. To allow for drop-outs we will aim to recruit 135 individuals, 45 per group.|Odds Ratio (OR)|0.64||||0.67|TWO_SIDED|95.0|0.14|3.0|||Logistic|||||3.00|0.14|0.67
74047150|NCT03236506|147646490|NON_INFERIORITY|Described in Statistical Analysis 1.|Odds Ratio (OR)|0.53||||0.41|TWO_SIDED|95.0|0.11|2.45|||logistic|||||2.45|0.11|0.41
74047151|NCT03236506|147646490|NON_INFERIORITY|Described in Statistical Analysis 1.|Odds Ratio (OR)|1.22||||0.82|TWO_SIDED|95.0|0.23|6.61|||logistic|||||6.61|0.23|0.82
74047152|NCT01925014|147646506|NON_INFERIORITY|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.013|||||TWO_SIDED|95.0|-0.008|0.033|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.||0.033|-0.008|
74047153|NCT01925014|147646507|NON_INFERIORITY|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.035|||||TWO_SIDED|95.0|-0.021|0.091|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.||0.091|-0.021|
74047154|NCT02044367|147646527|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.01|STANDARD_DEVIATION|26.8|||TWO_SIDED|90.0|125.773|149.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||149.250|125.773|
74047155|NCT02044367|147646527|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|130.43|STANDARD_DEVIATION|27.1|||TWO_SIDED|90.0|119.628|142.2|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||142.200|119.628|
74047156|NCT02044367|147646528|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|146.16|STANDARD_DEVIATION|31.6|||TWO_SIDED|90.0|132.217|161.576|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||161.576|132.217|
74047157|NCT02044367|147646528|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|141.06|STANDARD_DEVIATION|31.5|||TWO_SIDED|90.0|127.644|155.876|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||155.876|127.644|
74047158|NCT02044367|147646529|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.61|STANDARD_DEVIATION|26.5|||TWO_SIDED|90.0|126.418|149.797|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||149.797|126.418|
74047159|NCT02044367|147646529|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|132.0|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|120.714|144.342|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||144.342|120.714|
74047160|NCT02044367|147646530|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|147.8|STANDARD_DEVIATION|32.4|||TWO_SIDED|90.0|133.384|163.779|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||163.779|133.384|
74047161|NCT02044367|147646530|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|144.8|STANDARD_DEVIATION|32.0|||TWO_SIDED|90.0|130.853|160.242|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||160.242|130.853|
74047162|NCT03489850|147646533|SUPERIORITY||Parameter Estimate|0.34|STANDARD_ERROR_OF_MEAN|0.69||0.62|TWO_SIDED|95.0|-1.01|1.69|||Generalized Estimating Equation|||||1.69|-1.01|.62
73880762|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0023|TWO_SIDED|95.0|1.83|16.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.18|1.83|0.0023
74047163|NCT03489850|147646534|SUPERIORITY||Odds Ratio (OR)|0.55|||<|0.05|TWO_SIDED|95.0|0.3|0.98|||Generalized Estimating Equation|||||.98|.30|<0.05
74047164|NCT03489850|147646535|SUPERIORITY||Odds Ratio (OR)|0.83|||<|0.05|TWO_SIDED|95.0|0.47|1.48|||Generalized Estimating Equation|||||1.48|0.47|<0.05
74047165|NCT03489850|147646536|SUPERIORITY||F|7.36|||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
74047166|NCT00901394|147646588|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||For baseline comparisons among the three groups, one-way ANOVA was used for normally distributed variables and χ2 goodness-of-fit for categorical variables. To model the effects of B-vitamin treatment on nitrous-oxide-induced total homocysteine increase at the three different timepoints within individual patients and between the three groups, a linear mixed model with was used and we included a group × time interaction in the model.||||<0.05
74047167|NCT01388491|147646595|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.8||||0.5892|TWO_SIDED|95.0|-54.75|31.17||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||31.17|-54.75|0.5892
74047168|NCT01388491|147646596|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|3.0||||0.839|TWO_SIDED|95.0|-25.96|31.94||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||31.94|-25.96|0.839
74047169|NCT01388491|147646597|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.8||||0.0021|TWO_SIDED|95.0|-7.87|-1.77||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||-1.77|-7.87|0.0021
74047170|NCT01388491|147646598|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|3.2||||0.2312|TWO_SIDED|95.0|-2.08|8.58||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||8.58|-2.08|0.2312
74047171|NCT01388491|147646599|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.6||||0.344|TWO_SIDED|95.0|-1.7|4.85||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||4.85|-1.70|0.3440
73880763|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|7.33||||0.0015|TWO_SIDED|95.0|2.15|25.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.02|2.15|0.0015
73880764|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.78||||0.238|TWO_SIDED|95.0|0.68|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||4.66|0.68|0.2380
74047172|NCT01388491|147646600|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.3||||0.2522|TWO_SIDED|95.0|-0.24|0.92||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.92|-0.24|0.2522
74047173|NCT01388491|147646601|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.9||||0.0143|TWO_SIDED|95.0|0.58|5.13||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||5.13|0.58|0.0143
74047174|NCT01388491|147646602|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.5||||0.8507|TWO_SIDED|95.0|-4.87|5.91||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||5.91|-4.87|0.8507
74047175|NCT01388491|147646603|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1||||0.0459|TWO_SIDED|95.0|0.0|0.14||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.14|0.00|0.0459
74047176|NCT01388491|147646604|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1||||0.0318|TWO_SIDED|95.0|0.01|0.26||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.26|0.01|0.0318
74047177|NCT01388491|147646605|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|361.6||||0.1148|TWO_SIDED|95.0|-88.45|811.61||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||811.61|-88.45|0.1148
74047178|NCT01388491|147646606|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.2||||0.7136|TWO_SIDED|95.0|-35.92|52.39||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||52.39|-35.92|0.7136
74047179|NCT01388491|147646607|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1||||0.3903|TWO_SIDED|95.0|-0.29|0.11||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.11|-0.29|0.3903
74047180|NCT01388491|147646608|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|14.3||||0.1731|TWO_SIDED|95.0|-6.29|34.8||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||34.80|-6.29|0.1731
74047181|NCT00412113|147646624|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|19.03|||<|0.001||95.0|9.14|39.63||There was only one primary endpoint and the p-value was not adjusted for comparison.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the BP(\< 140/90 mmHg) and LDL goal (\< 100mg/dL) at Week 6.~With \~120 in each treatment arm, planned power was at least 90% to detect a difference between treatments, assuming 35% in the Caduet and 15% in the Norvasc arm achieving BP \<140/90 mmHg and LDL \<100 mg/dL and using a chi-square test with 0.05 two-sided significance level."||39.63|9.14|<0.001
74047182|NCT00412113|147646625|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|31.39|||<|0.001||95.0|12.61|78.09||No adjustment for p-value for secondary analysis|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<100 mg/dL) at Week 4.||78.09|12.61|<0.001
74047183|NCT00412113|147646626|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.2|||<|0.001||95.0|2.93|9.24||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<130mg/dL) at Week 4.||9.24|2.93|<0.001
74047184|NCT00412113|147646627|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.14|||<|0.001||95.0|2.89|9.11||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<130mg/dL) at Week 6.||9.11|2.89|<0.001
74047185|NCT00412113|147646628|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|65.51|||<|0.001||95.0|27.1|158.34||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving (\<100mg/DL) at Week 4.||158.34|27.10|<0.001
74047186|NCT00412113|147646629|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|42.04|||<|0.001||95.0|19.42|90.99||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving LDL-goal (\<100mg/DL) at Week 6.||90.99|19.42|<0.001
74047187|NCT00412113|147646630|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.785||95.0|0.6|1.98||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (\< 140/90 mmHg)at Week 4||1.98|0.60|0.785
73888085|NCT01746901|147309535|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.3604|TWO_SIDED|95.0|-6.0|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|-6.0|0.3604
74018225|NCT04033367|147587909|SUPERIORITY||Least square mean difference|-3.61|||<|0.001|TWO_SIDED|95.0|-5.68|-1.53||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-1.53|-5.68|<0.001
74018226|NCT04033367|147587910|SUPERIORITY||Least square mean difference|9.97||||0.297|TWO_SIDED|95.0|-8.86|28.79||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||28.79|-8.86|0.297
74018227|NCT02723201|147587920|SUPERIORITY_OR_OTHER||LS Mean Difference|0.402|||<|0.001|TWO_SIDED|90.0|0.32|0.505|||ANOVA|||Analysis of variance (ANOVA) was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90 percent (%) confidence interval (CI) was obtained by taking the antilog of the difference in the log transformed least square (LS) means and its CI, respectively.||0.505|0.320|<0.001
74018228|NCT02723201|147587920|SUPERIORITY_OR_OTHER||LS Mean Difference|1.216||||0.249|TWO_SIDED|90.0|1.016|1.455|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||1.455|1.016|0.249
74018229|NCT02723201|147587920|SUPERIORITY_OR_OTHER||LS Mean Difference|0.055|||<|0.001|TWO_SIDED|90.0|0.041|0.074|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.074|0.041|<0.001
74018230|NCT02723201|147587920|SUPERIORITY_OR_OTHER||LS Mean Difference|0.685||||0.054|TWO_SIDED|90.0|0.499|0.939|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.939|0.499|0.054
74018231|NCT02723201|147587922|SUPERIORITY_OR_OTHER||LS Mean Difference|0.648||||0.007|TWO_SIDED|90.0|0.497|0.844|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.844|0.497|0.007
74018232|NCT02723201|147587922|SUPERIORITY_OR_OTHER||LS Mean Difference|1.18||||0.423|TWO_SIDED|90.0|1.088|1.279|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||1.279|1.088|0.423
74018233|NCT02723201|147587922|SUPERIORITY_OR_OTHER||LS Mean Difference|0.116|||<|0.001|TWO_SIDED|90.0|0.077|0.176|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.176|0.077|<0.001
74018234|NCT02723201|147587922|SUPERIORITY_OR_OTHER||LS Mean Difference|0.836||||0.037|TWO_SIDED|90.0|0.731|0.957|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.957|0.731|0.037
74018235|NCT00094757|147587973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.9|<|0.001|TWO_SIDED|95.0|-0.82|-0.39||Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)|ANCOVA|||||-0.39|-0.82|<0.001
74018236|NCT00094757|147587973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_DEVIATION|0.9|<|0.001|TWO_SIDED|95.0|-0.7|-0.26|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)||||-0.26|-0.70|<0.001
74018237|NCT00094757|147587974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.7|STANDARD_DEVIATION|45.9|<|0.001|TWO_SIDED|95.0|-30.5|-8.9|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status||||-8.9|-30.5|<0.001
74018238|NCT00094757|147587974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.9|STANDARD_DEVIATION|45.9|<|0.002|TWO_SIDED|95.0|-27.6|-6.1|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status||||-6.1|-27.6|<0.002
74018239|NCT04317274|147587984|OTHER||Slope|-0.19||||0.21|TWO_SIDED||||||Mixed Models Analysis|Note: original plan was to conduct ANOVAs, but failed tests of assumptions||We tested for interaction effect of order and video version within the high cholesterol group.||||0.21
74018240|NCT04317274|147587984|OTHER||Slope|-1.23|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Original plan was to conduct ANOVAs, but failed tests of assumptions||We tested for interaction effect of order and video version within the colorectal cancer group.||||<0.001
74018241|NCT04317274|147587985|OTHER||Slope|0.58|||<|0.001|TWO_SIDED||||||Pearson's correlation coefficient|||We examined the correlation between SDM Process and SDM-Q9 scores in the high cholesterol group.||||<.001
74018242|NCT04317274|147587985|OTHER||Slope|0.71|||<|0.001|TWO_SIDED||||||Pearson's correlation coefficient]|||We examined the correlation between SDM Process and SDM-Q9 scores in the colorectal cancer group.||||<.001
74018243|NCT04849780|147587999|NON_INFERIORITY|It was calculated that 80 participants randomized in a 1:1 fashion between the two arms would have at least 80% power to detect a 5 points difference in mean change from baseline overall comfort. Sample size was determined using a 2-sided Satterthwaite t-test assuming unequal variances with an alpha level of 5%. A non-inferiority margin of -5 points was used.|Population Mean Difference|29.279|||||TWO_SIDED|95.0|24.602|33.732|||Bootstrapping methods||Population Mean difference was calculated as Arm 1 minus Arm 2|||33.732|24.602|
74018244|NCT04849780|147588000|NON_INFERIORITY|Sample size was determined based on the primary hypothesis only. A non-inferiority margin of 3 points was used.|LS Mean|-10.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-12.7|-8.6|||Heterogeneous Mixed model analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Arm 1 minus Arm 2 (subjects' own contact lens)|||-8.6|-12.7|
74018245|NCT04849780|147588001|NON_INFERIORITY|Sample size was determined based on the primary hypothesis only. A non-inferiority margin of -5 points was used.|LS Mean|25.9|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|19.0|32.9|||Heterogeneous Mixed model analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Arm 2 (senofilcon A), minus Arm 2 (subjects' own contact lens)|||32.9|19.0|
74018246|NCT04849780|147588002|NON_INFERIORITY|A non-inferiority margin of 3 points was used.|LS Mean|-8.5|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-10.1|-7.0|||Heterogeneous mixed model analysis||Mean difference was calculated as Arm 2 (senofilcon A) minus Arm 2 (subjects' own contact lens)|||-7.0|-10.1|
74018247|NCT02551159|147588003|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.787|TWO_SIDED|95.0|0.69|1.32||2 sided|Log Rank|||Statistical analysis of number of deaths||1.32|0.69|0.787
74018248|NCT02551159|147588005|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.634|TWO_SIDED|95.0|0.8|1.39||2 sided|Log Rank|||||1.39|0.80|0.634
74018249|NCT02551159|147588007|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.287|TWO_SIDED|95.0|0.94|1.8||2 sided|Log Rank|||||1.80|0.94|0.287
74018250|NCT02551159|147588007|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.028|TWO_SIDED|95.0|0.99|1.76||2 sided|Log Rank|||||1.76|0.99|0.028
74018251|NCT02551159|147588008|SUPERIORITY||Odds Ratio (OR)|0.19|||<|0.001|TWO_SIDED|95.0|0.1|0.37||2 sided|Regression, Logistic|||Statistical analysis of number with a response||0.37|0.10|<0.001
74018252|NCT02551159|147588008|SUPERIORITY||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.2|0.57||2 sided|Regression, Logistic|||Statistical analysis of number with a response||0.57|0.20|<0.001
74018253|NCT02551159|147588010|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.811|TWO_SIDED|95.0|0.83|1.27||2 sided|Log Rank|||Statistical analysis of number of deaths||1.27|0.83|0.811
74018254|NCT02551159|147588010|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.624|TWO_SIDED|95.0|0.87|1.25|||Log Rank|||Statistical analysis of number of deaths||1.25|0.87|0.624
74018255|NCT02551159|147588013|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.006|TWO_SIDED|95.0|1.1|1.68||2 sided|Log Rank|||||1.68|1.10|0.006
74018256|NCT02551159|147588013|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.008|TWO_SIDED|95.0|1.06|1.53||2 sided|Log Rank|||||1.53|1.06|0.008
74018257|NCT02551159|147588014|SUPERIORITY||Odds Ratio (OR)|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.33||2 sided|Regression, Logistic|||||0.33|0.13|<0.001
74018258|NCT02551159|147588014|SUPERIORITY||Odds Ratio (OR)|0.29|||<|0.001|TWO_SIDED|95.0|0.2|0.41||2 sided|Regression, Logistic|||||0.41|0.20|<0.001
74018259|NCT00993928|147588022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q3: Percent change in sleep latency from baseline to week 7.||||0.85
74018260|NCT00993928|147588022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q6A: Percent change in time to fall back asleep from baseline to week 7.||||0.86
74018261|NCT00993928|147588024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|||||||Chi-squared|||||||0.42
74018262|NCT00993928|147588026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||t-test, 2 sided|||Compare percent change from baseline to week 7 Distress Thermometer score.||||0.64
74018263|NCT01665144|147588027|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0134|TWO_SIDED|95.0|0.65|0.95|||Cox proportional hazards model|||||0.95|0.65|0.0134
74018264|NCT01665144|147588028|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4398|TWO_SIDED|95.0|0.8|1.1|||Cox proportional hazards model|||||1.10|0.80|0.4398
74018265|NCT01665144|147588029|SUPERIORITY||Mean Difference (Final Values)|-613.1|STANDARD_ERROR_OF_MEAN|95.39|<|0.0001|TWO_SIDED|95.0|-800.2|-426.0|||Mixed model for repeated measures|||Month 12||-426.0|-800.2|<0.0001
74018266|NCT01665144|147588029|SUPERIORITY||Mean Difference (Final Values)|-777.5|STANDARD_ERROR_OF_MEAN|108.62|<|0.0001|TWO_SIDED|95.0|-990.6|-564.4|||Mixed model for repeated measures|||Month 24||-564.4|-990.6|<0.0001
74018267|NCT01665144|147588029|SUPERIORITY||Mean Difference (Final Values)|-695.3|STANDARD_ERROR_OF_MEAN|92.79|<|0.0001|TWO_SIDED|95.0|-877.3|-513.3|||Mixed model for repeated measures|||Average over Month 12 and Month 24||-513.3|-877.3|<0.0001
74018268|NCT01665144|147588030|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0058|TWO_SIDED|95.0|0.6|0.92|||Cox proportional hazards model|||||0.92|0.60|0.0058
74018269|NCT01665144|147588031|SUPERIORITY||ARR ratio|0.445|||<|0.0001|TWO_SIDED|95.0|0.337|0.587|||Negative binomial regression model|||||0.587|0.337|<0.0001
74018270|NCT01665144|147588032|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.7|||Cox proportional hazards model|||||0.70|0.41|<0.0001
74018271|NCT01665144|147588034|SUPERIORITY||Mean Difference (Final Values)|-1.83|STANDARD_ERROR_OF_MEAN|1.03||0.0764|TWO_SIDED|95.0|-3.85|0.19|||Repeated measures model|||Month 12||0.19|-3.85|0.0764
74018272|NCT01665144|147588034|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.359||0.3671|TWO_SIDED|95.0|-3.89|1.44|||Repeated measures model|||Month 24||1.44|-3.89|0.3671
74018273|NCT01665144|147588035|SUPERIORITY||Rate ratio|0.126|||<|0.0001|TWO_SIDED|95.0|0.083|0.191|||Negative binomial regression model|||Month 12||0.191|0.083|<0.0001
74018274|NCT01665144|147588035|SUPERIORITY||Rate ratio|0.178|||<|0.0001|TWO_SIDED|95.0|0.087|0.362|||Negative binomial regression model|||Month 24||0.362|0.087|<0.0001
74018275|NCT01665144|147588036|SUPERIORITY||Rate ratio|0.266|||<|0.0001|TWO_SIDED|95.0|0.215|0.328|||Regression model|Repeated measures negative binomial regression model||Month 12||0.328|0.215|<0.0001
74018276|NCT01665144|147588036|SUPERIORITY||Rate ratio|0.142|||<|0.0001|TWO_SIDED|95.0|0.103|0.196|||Regression model|Repeated measures negative binomial regression model||Month 24||0.196|0.103|<0.0001
73880765|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.61||||0.012|TWO_SIDED|95.0|1.33|9.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.81|1.33|0.0120
73880766|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.25||||0.091|TWO_SIDED|95.0|0.88|5.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.77|0.88|0.0910
73880767|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.93||||0.1926|TWO_SIDED|95.0|0.72|5.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.18|0.72|0.1926
73880768|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1017|TWO_SIDED|95.0|0.85|6.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.15|0.85|0.1017
73880769|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0153|TWO_SIDED|95.0|1.29|11.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.45|1.29|0.0153
73880770|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|7.52||||0.0034|TWO_SIDED|95.0|1.95|28.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||28.98|1.95|0.0034
73880771|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4539|TWO_SIDED|95.0|0.55|3.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.76|0.55|0.4539
73880772|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.03||||0.0327|TWO_SIDED|95.0|1.1|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.40|1.10|0.0327
73880773|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0555|TWO_SIDED|95.0|0.98|7.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.30|0.98|0.0555
73880774|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.64||||0.3505|TWO_SIDED|95.0|0.58|4.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.67|0.58|0.3505
73880775|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0265|TWO_SIDED|95.0|1.17|13.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.11|1.17|0.0265
73880776|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0174|TWO_SIDED|95.0|1.32|17.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||17.32|1.32|0.0174
73880777|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|8.95||||0.0075|TWO_SIDED|95.0|1.8|44.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||44.61|1.80|0.0075
73880778|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1228|TWO_SIDED|95.0|0.78|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.68|0.78|0.1228
73880779|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0431|TWO_SIDED|95.0|1.04|10.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.38|1.04|0.0431
73880780|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0851|TWO_SIDED|95.0|0.87|8.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.35|0.87|0.0851
73880781|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.45||||0.4726|TWO_SIDED|95.0|0.53|3.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.99|0.53|0.4726
74018277|NCT01665144|147588037|SUPERIORITY||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.0367|<|0.0001|TWO_SIDED|95.0|0.103|0.247|||Repeated measures model|||Month 12||0.247|0.103|<0.0001
74018278|NCT01665144|147588037|SUPERIORITY||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.0549||0.0196|TWO_SIDED|95.0|0.021|0.236|||Repeated measures model|||Month 24||0.236|0.021|0.0196
74018279|NCT01665144|147588038|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.68|1.11|||Cox proportional hazard model|||Without superimposed relapses at baseline||1.11|0.68|
74047188|NCT00412113|147646631|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.171||95.0|0.83|2.88||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (\< 140/90 mmHg) at Week 6.||2.88|0.83|0.171
74047189|NCT00412113|147646632|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.76||||0.585||95.0|-1.97|3.48||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 4.||3.48|-1.97|0.585
74047190|NCT00412113|147646633|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0|||>|0.999||95.0|-2.01|2.01||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 4.||2.01|-2.01|> 0.999
74047191|NCT00412113|147646634|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.363||95.0|-2.83|1.04|||ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in pulse rate at Week 4.||1.04|-2.83|0.363
74047192|NCT00412113|147646635|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-3.25||||0.02||95.0|-5.99|-0.51||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 6.||-0.51|-5.99|0.020
74047193|NCT00412113|147646636|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.87||||0.351||95.0|-2.71|0.97||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 6.||0.97|-2.71|0.351
74047194|NCT00412113|147646637|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.922||95.0|-1.91|2.11||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline in pulse rate at Week 6.||2.11|-1.91|0.922
74047195|NCT00412113|147646638|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-49.3|||<|0.001||95.0|-54.68|-43.91||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 4.||-43.91|-54.68|<0.001
74047196|NCT00412113|147646639|SUPERIORITY_OR_OTHER_LEGACY||difference in LS Means|-0.3||||0.739||95.0|-2.07|1.47||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 4.||1.47|-2.07|0.739
74047197|NCT00412113|147646640|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-57.9|||<|0.001||95.0|-64.02|51.81||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 4.||51.81|-64.02|<0.001
74047198|NCT00412113|147646641|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-47.27|||<|0.001||95.0|-63.37|-31.16||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TG at Week 4.||-31.16|-63.37|<0.001
74047199|NCT00412113|147646642|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-51.21|||<|0.001||95.0|-56.88|-45.55||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 6.||-45.55|-56.88|<0.001
74047200|NCT00412113|147646643|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.02||||0.329||95.0|-3.07|1.03||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 6.||1.03|-3.07|0.329
74096796|NCT03433755|147742732|SUPERIORITY||Treatment difference|-61.45|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-69.25|-53.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-53.65|-69.25|< 0.0001
74047201|NCT00412113|147646644|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-62.07|||<|0.001||95.0|-68.49|-55.65||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 6.||-55.65|-68.49|<0.001
74047202|NCT00412113|147646645|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-53.95|||<|0.001||95.0|-77.61|-30.29||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change in TG from baseline in at Week 6.||-30.29|-77.61|<0.001
74047203|NCT00412113|147646646|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.4|||<|0.001||95.0|-3.1|-1.7||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline to Week 4 in Framingham predicted absolute 10-year risk.||-1.7|-3.1|<0.001
74047204|NCT00412113|147646647|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.8|||<|0.001||95.0|-3.5|-2.1||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline to Week 6 in Framingham predicted absolute 10-year risk.||-2.1|-3.5|<0.001
74047205|NCT00864123|147646648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_DEVIATION|6.3|<|0.05||95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CY-BOCS Total Score) fixed-effects linear regression with time as the repeated measure. Cohen's d was used to examine the magnitude of treatment effects.||||<0.05
73888086|NCT01746901|147309535|SUPERIORITY_OR_OTHER||LS Mean Difference|6.2||||0.2725|TWO_SIDED|95.0|-5.0|17.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.4|-5.0|0.2725
74047206|NCT00864123|147646649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|1.1|<|0.05|TWO_SIDED|95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CGI-Severity) fixed-effects linear regression with time as the repeated measure. Cohen's d was used to examine the magnitude of treatment effects.||||<0.05
74047207|NCT00796224|147646657|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|157.98||||||90.0|98.87|252.44|||ANOVA|||Test (60 mg/kg Azithromycin ER)/ Reference (30 mg/kg Azithromycin IR)||252.44|98.87|
74047208|NCT00796224|147646659|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|91.63||||||90.0|56.21|149.38|||ANOVA|||||149.38|56.21|
74047209|NCT00796224|147646661|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|65.44||||||90.0|23.56|181.77|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 1 hour postdose||181.77|23.56|
74047210|NCT00796224|147646661|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|50.57||||||90.0|25.24|101.3|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 2 hours postdose||101.30|25.24|
74047211|NCT00796224|147646661|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|100.07||||||90.0|57.91|172.92|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 3 hours postdose||172.92|57.91|
74047212|NCT00796224|147646661|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|164.93||||||90.0|103.78|262.12|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 4 hours postdose||262.12|103.78|
74047213|NCT00796224|147646661|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|174.41||||||90.0|110.07|276.36|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 8 hours postdose||276.36|110.07|
74047214|NCT00796224|147646661|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|173.01||||||90.0|111.45|268.55|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 24 hours postdose||268.55|111.45|
74047215|NCT00796224|147646661|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|189.35||||||90.0|129.76|276.3|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 48 hours postdose||276.30|129.76|
74047216|NCT00796224|147646661|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|183.14||||||90.0|124.61|269.14|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 72 hours postdose||269.14|124.61|
74047217|NCT04195750|147646664|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00031|TWO_SIDED|95.0|0.63|0.88|||Log Rank|One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.88|0.63|0.00031
74047218|NCT04195750|147646665|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.17644|TWO_SIDED|95.0|0.77|1.1|||Log Rank|One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||1.10|0.77|0.17644
74018280|NCT01665144|147588038|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.49|0.91|||Cox proportional hazard model|||With superimposed relapses at baseline||0.91|0.49|
74018281|NCT01665144|147588038|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.06|||Cox proportional hazard model|||Without superimposed relapses post-treatment||1.06|0.69|
74018282|NCT01665144|147588038|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.53|1.19|||Cox proportional hazard model|||With superimposed relapses post-treatment||1.19|0.53|
74018283|NCT01665144|147588039|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.46|0.91|||Cox proportional hazard model|||Rapidly evolving patients||0.91|0.46|
74018284|NCT01665144|147588039|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.69|1.09|||Cox proportional hazard model|||Not rapidly evolving patients||1.09|0.69|
74018285|NCT01665144|147588040|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.65|0.99|||Cox proportional hazard model|||With moderate or severe course of disease||0.99|0.65|
74018286|NCT01665144|147588040|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.47|1.13|||Cox proportional hazard model|||Without moderate or severe course of disease||1.13|0.47|
74018287|NCT03551743|147588099|SUPERIORITY||Least Squares Means (Difference)|-65.02||||0.0344|TWO_SIDED||||||ANCOVA|||||||0.0344
74018288|NCT03551743|147588099|SUPERIORITY||Least Squares Means (Difference)|-92.38||||0.0014|TWO_SIDED||||||ANCOVA|||||||0.0014
74018289|NCT03551743|147588099|SUPERIORITY||Least Squares Means (Difference)|-46.26||||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
74018290|NCT03551743|147588100|SUPERIORITY||Least Squares Means (Difference)|88722.37||||0.0032|TWO_SIDED||||||ANCOVA|||||||0.0032
74018291|NCT03551743|147588100|SUPERIORITY||Least Squares Means (Difference)|151500.3||||0.0003|TWO_SIDED||||||ANCOVA|||||||0.0003
74018292|NCT03551743|147588100|SUPERIORITY||Least Squares Means (Difference)|198560.4||||0.0004|TWO_SIDED||||||ANCOVA|||||||0.0004
74018293|NCT03551743|147588101|SUPERIORITY||Least Squares Means (Difference)|-76.05||||0.1874|TWO_SIDED||||||ANCOVA|||||||0.1874
74018294|NCT03551743|147588101|SUPERIORITY||Least Squares Means (Difference)|-27.98||||0.386|TWO_SIDED||||||ANCOVA|||||||0.386
74018295|NCT03551743|147588101|SUPERIORITY||Least Squares Means (Difference)|-49.99|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
74018296|NCT01724528|147588140|SUPERIORITY_OR_OTHER||Least squares means difference|-196.794|||<|0.0001|TWO_SIDED|95.0|-238.6|-154.988|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and \> 7.5 mg/dL) were inserted in the ANCOVA model as covariates||-154.988|-238.600|<0.0001
74018297|NCT01724528|147588141|SUPERIORITY_OR_OTHER||Least squares means difference|4.097||||0.0903|TWO_SIDED|95.0|-0.6467|8.8406|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and \> 7.5 mg/dL) were inserted in the ANCOVA model as covariates||8.8406|-0.6467|0.0903
74018298|NCT01724528|147588142|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0231||||0.1993|TWO_SIDED|95.0|-0.0153|0.0654|||Wilson's confidence interval|||||0.0654|-0.0153|0.1993
74018299|NCT01724528|147588143|SUPERIORITY_OR_OTHER||Relative risk|0.875||||0.8488|TWO_SIDED|95.0|0.4408|1.7369|||Chi-squared|||||1.7369|0.4408|0.8488
73880782|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1289|TWO_SIDED|95.0|0.79|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.67|0.79|0.1289
73880783|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.39||||0.04|TWO_SIDED|95.0|1.06|10.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.84|1.06|0.0400
74047219|NCT04195750|147646666|SUPERIORITY|P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Difference in Percentage|18.4|||<|1e-05|TWO_SIDED|95.0|14.0|23.2||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen||Belzutifan minus Everolimus|||23.2|14.0|<0.00001
74047220|NCT04195750|147646670|OTHER||Hazard Ratio (HR)|0.75||||0.0185|TWO_SIDED|95.0|0.58|0.96|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.96|0.58|0.0185
74047221|NCT04195750|147646671|OTHER||Hazard Ratio (HR)|0.93||||0.5533|TWO_SIDED|95.0|0.72|1.2|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||1.20|0.72|0.5533
74047222|NCT04195750|147646672|OTHER||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.69|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.69|0.41|<0.0001
74047223|NCT04195750|147646673|OTHER||Difference in Least Squares (LS) Means|6.38|||<|0.0001|TWO_SIDED|95.0|3.21|9.55|||t-test, 2 sided||Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||9.55|3.21|<0.0001
74047224|NCT04195750|147646674|OTHER||Difference in LS Means|2.47||||0.1134|TWO_SIDED|95.0|-0.59|5.54|||t-test, 2 sided||Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||5.54|-0.59|0.1134
74047225|NCT04195750|147646675|OTHER||Difference in LS Means|1.45||||0.0002|TWO_SIDED|95.0|0.7|2.19|||t-test, 2 sided||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||2.19|0.70|0.0002
74047226|NCT04195750|147646676|OTHER||Difference in LS Means|3.72||||0.0051|TWO_SIDED|95.0|1.12|6.31|||t-test, 2 sided||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||6.31|1.12|0.0051
74047227|NCT03559192|147646677|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.25|=|0.0443|ONE_SIDED|80.0||-1.09|||Mixed Models Analysis|||||-1.09||= 0.0443
73880784|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|8.22||||0.0097|TWO_SIDED|95.0|1.67|40.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||40.55|1.67|0.0097
73880785|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.97||||0.226|TWO_SIDED|95.0|0.66|5.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.94|0.66|0.2260
73880786|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|8.63||||0.0031|TWO_SIDED|95.0|2.07|35.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||35.96|2.07|0.0031
74047228|NCT03559192|147646678|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.05||0.0017|ONE_SIDED|80.0||-2.21|||Mixed Models Analysis|||||-2.21||0.0017
74047229|NCT03559192|147646680|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.87|=|0.4188|ONE_SIDED|80.0||0.41|||Mixed Models Analysis|||||0.41||= 0.4188
74047230|NCT03559192|147646681|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.2503|ONE_SIDED|80.0||0.1|||Mixed Models Analysis|||||0.10||0.2503
74047231|NCT03517722|147646696|SUPERIORITY||Odds Ratio (OR)|0.6||||0.042|TWO_SIDED|95.0|0.4|1.0|||Regression, Logistic|||||1.0|0.4|0.042
74047232|NCT02422186|147646703|SUPERIORITY||Difference of Least Square (LS) Means|-3.6|||=|0.059|TWO_SIDED|95.0|-7.2|0.07|||Mixed Model for Repeated Measures|||||0.07|-7.20|=0.059
74047233|NCT02422186|147646704|OTHER||Least Square (LS) Mean Difference|-3.6|||=|0.052|TWO_SIDED|95.0|-7.16|-0.03|||ANCOVA|||||-0.03|-7.16|=0.052
74096797|NCT03433755|147742732|SUPERIORITY||Treatment difference|-56.65|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-63.66|-49.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-49.63|-63.66|< 0.0001
74047234|NCT01425307|147646711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We hypothesized that the Alternative arm mean TCD velocity at 24 months will be less than the Standard arm mean TCD velocity plus 15cm/sec. We used Lan-DeMets boundaries to control overall Type I error rate at α = 0.05. For looks at exactly 1/3, 2/3, and 100 percent of the completed subjects, the cumulative α were estimated to be 0.0001, 0.001, and 0.05, respectively.|Mean Difference (Final Values)|4.54|||<|0.05|TWO_SIDED|95.0|0.1|8.98||P value for non inferiority was 8.82 X 10\^-16|Mixed Models Analysis|Linear mixed model||Participants were randomized at a central site, stratified by site with a block size of four, and an adaptive randomization scheme was used to balance the covariates of baseline age and TCD velocity. The treatment period lasted 24 months. The primary study endpoint was the 24 month TCD velocity calculated from a general linear mixed model, with the non-inferiority margin set at 15 cm/s. The primary analysis was done in the intention-to-treat population.||8.98|0.10|<0.05
74047235|NCT01425307|147646715|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74047236|NCT01425307|147646725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||t-test, 2 sided|||||||0.0011
74047237|NCT03573804|147646727|OTHER|A two-tailed paired T-test for equivalence was used to evaluate equivalence between the average raw tumor.|Mean Difference (Net)|224.675|STANDARD_ERROR_OF_MEAN|67.89|<|0.001|TWO_SIDED|95.0|90.26044|359.08956||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A paired two-tailed t-test was used on the paired prone-to-supine tumor intensity values.||Regions of interest (ROIs) for tumor were defined by the radiologist segmentation of tumor in supine and prone positions. ROIs for the surrounding tissue were selected such that tumor and normal regions had equal volumes. The alpha level was assumed to be of 0.05 (dof = 60), and the null hypothesis of equivalence (mu = 0).||359.08956|90.26044|<0.001
74047238|NCT03573804|147646728|OTHER|A two-tailed paired T-test was used to compare sample means in between the prone and supine mean benign tissue intensities.|Mean Difference (Net)|165.833|STANDARD_ERROR_OF_MEAN|44.19|<|0.001|TWO_SIDED|95.0|78.34708|253.31892||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A paired two-tailed t-test was used on the paired prone-to-supine normal tissue intensity values.||Regions of interest (ROIs) for surrounding tissues were selected as the surrounding benign tissue regions directly adjacent to the segmented tumor regions. Tumor and surrounding regions had equal volumes. The mean surrounding region intensities reported were all calculated from the prone and supine T1-weighted MR images segmented by the radiologist.||253.31892|78.34708|<0.001
74047239|NCT03573804|147646729|OTHER|A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.|Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.08||0.0058|TWO_SIDED|95.0|-0.04209|0.28209||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.||The ratios of tumor-to-surrounding tissue intensities, as calculated in Secondary Objective Part A, were compared between prone and supine T1-weighted MR image scans.||0.28209|-0.04209|0.0058
74047240|NCT03573804|147646731|SUPERIORITY|||||||0.00049664|||||||Students two-tailed paired t-test|||||||0.00049664
74047241|NCT03399786|147646732|SUPERIORITY||Least Squares (LS) Mean Difference|-49.0|STANDARD_ERROR_OF_MEAN|8.0|<|0.0001|TWO_SIDED|95.0|-65.0|-33.1|||Mixed-effect Model Repeat Measure (MMRM)|||Confidence interval (CI) with p-value was based on-treatment group difference of least squares (LS) means using mixed-effect model repeat measurement (MMRM), randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated LDL-C value.||-33.1|-65.0|< 0.0001
74047242|NCT03399786|147646733|SUPERIORITY||Least Squares (LS) Mean Difference|-36.9|STANDARD_ERROR_OF_MEAN|5.9|<|0.0001|TWO_SIDED|95.0|-48.6|-25.2|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated Apo B value.||-25.2|-48.6|< 0.0001
74047243|NCT03399786|147646734|SUPERIORITY||Least Squares (LS) Mean Difference|-51.7|STANDARD_ERROR_OF_MEAN|6.6|<|0.0001|TWO_SIDED|95.0|-64.8|-38.5|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated non-HDL-C value.||-38.5|-64.8|< 0.0001
74047244|NCT03399786|147646735|SUPERIORITY||Least Squares (LS) Mean Difference|-48.4|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|95.0|-58.7|-38.1|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated TC value.||-38.1|-58.7|< 0.0001
74096798|NCT03433755|147742733|SUPERIORITY||Treatment Difference|-56.26|STANDARD_ERROR_OF_MEAN|3.12|<|0.0001|TWO_SIDED|95.0|-62.44|-50.07||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-50.07|-62.44|< 0.0001
74096799|NCT03433755|147742733|SUPERIORITY||Treatment Difference|-57.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-62.35|-51.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-51.65|-62.35|< 0.0001
73880787|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|10.16||||0.0043|TWO_SIDED|95.0|2.07|49.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||49.90|2.07|0.0043
74047245|NCT03399786|147646736|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|25.2|||<|0.0001|TWO_SIDED|95.0|5.7|110.5|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for secondary endpoints in pre-specified order to control type I error.Testing sequence continued only when previous endpoint was statistically significant at 0.05.Multiple imputation addressed missing data at week 24.Combined estimate for odds ratio obtained by Rubin's formulae.Logistic regression models stratified by randomized strata include fixed categorical effect of treatment group \& continuous fixed covariate of baseline calculated LDL-C.||110.5|5.7|< 0.0001
74047246|NCT03399786|147646737|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|24.2|||=|0.0028|TWO_SIDED|95.0|3.0|195.6|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for secondary endpoints in pre-specified order to control type I error.Testing sequence continued only when previous endpoint was statistically significant at 0.05.Multiple imputation addressed missing data at week 24.Combined estimate for odds ratio obtained by Rubin's formulae.Logistic regression models stratified by randomized strata include fixed categorical effect of treatment group \& continuous fixed covariate of baseline calculated LDL-C.||195.6|3.0|= 0.0028
74047247|NCT03399786|147646738|SUPERIORITY||Least Squares (LS) Mean Difference|-132.1|STANDARD_ERROR_OF_MEAN|21.5|<|0.0001|TWO_SIDED|95.0|-175.3|-88.9|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated LDL-C value.||-88.9|-175.3|< 0.0001
74047248|NCT03399786|147646739|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|0.1|||=|0.0845|TWO_SIDED|95.0|0.0|1.3|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||1.3|0|= 0.0845
74047249|NCT03399786|147646740|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|5.7|||=|0.0203|TWO_SIDED|95.0|1.3|24.9||The p-value is nominal for descriptive purpose only due to statistical hypothesis testing terminated previously.|Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||24.9|1.3|= 0.0203
74047250|NCT03399786|147646741|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|0.1|||=|0.0004|TWO_SIDED|95.0|0.0|0.3||The p-value is nominal for descriptive purpose only due to statistical hypothesis testing terminated previously.|Logistic Regression Models Analysis|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||0.3|0.0|= 0.0004
74047251|NCT01673373|147646749|OTHER|Due to the early termination of enrollment, all inferential analyses were interpreted as descriptive and carried out in an exploratory manner.|||||<|0.0001||||||The p-value was computed using a one-sided exact test of the difference between the observed rate and the Performance Goal (equal to 70%). The defined threshold for statistical significance is .025.|one-sided exact|||The original Performance Goal of 70% patency rate was derived from a thorough literature review of trials with renal bare metal stent placement. Other assumptions included a determination of samples size based upon a one-sided alpha of 0.025 and desired power of 87%, and assumption of 10% attrition. The null hypothesis was that the incidence of primary patency at 9 months is less than or equal to 70%.|"The cumulative incidence of primary patency was computed as the number of subject-lesions with primary patency at 9 months divided by the number of subject-lesions and was analyzed using the allowable window of 243 to 303 trial days.~An exact binomial one-sided 95% CI was constructed and the lower limit compared to the Performance Goal equal to 70%."|||<.0001
74047252|NCT01673373|147646750|OTHER|A one-sided 95% Confidence Interval for the mean difference between baseline and 9-month systolic blood pressure was constructed and the lower limit compared to the 10 mmHg performance goal. A p-value of the difference between the estimated systolic blood pressure change from the baseline and the performance goal was computed using a paired t-test.||||||0.0192||||||The defined threshold for statistical significance is .025.|t-test, 1 sided|||The primary endpoint of systolic blood pressure was analyzed according to the Performance Goal of a decrease in systolic blood pressure of 10 mmHg between procedure and 9 months.||||.0192
73888087|NCT01746901|147309535|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4||||0.3461|TWO_SIDED|95.0|-5.8|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.6|-5.8|0.3461
73880788|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5571|TWO_SIDED|95.0|0.47|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.04|0.47|0.5571
73880789|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1911|TWO_SIDED|95.0|0.69|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.59|0.69|0.1911
73880790|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.74||||0.1101|TWO_SIDED|95.0|0.8|9.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.41|0.80|0.1101
73880791|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|6.86||||0.0199|TWO_SIDED|95.0|1.36|34.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||34.74|1.36|0.0199
73880792|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.96||||0.26|TWO_SIDED|95.0|0.61|6.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.33|0.61|0.2600
73880793|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|8.93||||0.009|TWO_SIDED|95.0|1.73|46.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||46.19|1.73|0.0090
74047253|NCT05505734|147646832|SUPERIORITY||Hazard Ratio (HR)|0.535|||<|0.001|TWO_SIDED|95.0|0.392|0.73||The pre-specified alpha (type I error) at the IA was set at 0.003 for the primary and first secondary endpoint|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.730|0.392|<0.001
74047254|NCT05505734|147646833|SUPERIORITY||Hazard Ratio (HR)|0.539|||<|0.001|TWO_SIDED|95.0|0.397|0.733||The pre-specified alpha (type I error) at the IA was set at 0.003 for the primary and first secondary endpoint|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.733|0.397|<0.001
74096800|NCT03433755|147742734|SUPERIORITY||Treatment difference|-55.69|STANDARD_ERROR_OF_MEAN|3.67|<|0.0001|TWO_SIDED|95.0|-62.98|-48.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-48.41|-62.98|< 0.0001
74096801|NCT03433755|147742734|SUPERIORITY||Treatment difference|-51.21|STANDARD_ERROR_OF_MEAN|3.45|<|0.0001|TWO_SIDED|95.0|-58.06|-44.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-44.37|-58.06|< 0.0001
73880794|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|17.22||||0.0089|TWO_SIDED|95.0|2.04|145.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||145.2|2.04|0.0089
73880795|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8966|TWO_SIDED|95.0|0.36|3.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.19|0.36|0.8966
73880796|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.47||||0.5031|TWO_SIDED|95.0|0.48|4.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.51|0.48|0.5031
73880797|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2603|TWO_SIDED|95.0|0.59|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.92|0.59|0.2603
73880798|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.16||||0.2447|TWO_SIDED|95.0|0.59|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.88|0.59|0.2447
73880799|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.64||||0.4239|TWO_SIDED|95.0|0.49|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.55|0.49|0.4239
73888088|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4||||0.1828|TWO_SIDED|95.0|-1.1|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-1.1|0.1828
73880800|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|11.72||||0.024|TWO_SIDED|95.0|1.38|99.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||99.35|1.38|0.0240
74047255|NCT05505734|147646834|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.001|TWO_SIDED|95.0|0.405|0.724||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.724|0.405|<0.001
73880801|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1457|TWO_SIDED|95.0|0.72|9.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.41|0.72|0.1457
74047256|NCT05505734|147646835|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.001|TWO_SIDED|95.0|0.406|0.72||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.720|0.406|<0.001
74047257|NCT05505734|147646836|SUPERIORITY||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.34|0.64||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Negative binomial|||Rates, rate ratios and two-sided p-values were estimated from a negative binomial model with treatment, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A rate ratio less than 1 favors BDA MDI treatment group.||0.64|0.34|<0.001
74047258|NCT05505734|147646837|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.63||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Negative binomial|||Rates, rate ratios and two-sided p-values were estimated from a negative binomial model with treatment, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A rate ratio less than 1 favors BDA MDI treatment group.||0.63|0.33|<0.001
74047259|NCT05505734|147646838|SUPERIORITY||||||<|0.001||||||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Wilcoxon rank sum|||||||<0.001
74047260|NCT05505734|147646839|SUPERIORITY||||||<|0.001||||||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Wilcoxon rank sum|||||||<0.001
74047261|NCT00554853|147646851|SUPERIORITY_OR_OTHER|||||||0.63|||||||ANCOVA|||||||0.63
74047262|NCT02203916|147646858|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.317|STANDARD_ERROR_OF_MEAN|2.4502|<|0.001|TWO_SIDED|95.0|-18.138|-8.497||"Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis all treatment groups equal was first rejected at 0.05."|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.||||-8.497|-18.138|<0.001
74047263|NCT02203916|147646858|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.955|STANDARD_ERROR_OF_MEAN|2.447|<|0.001|TWO_SIDED|95.0|-19.77|-10.141||"Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis all treatment groups equal was first rejected at 0.05."|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.||||-10.141|-19.770|<0.001
74047264|NCT00414973|147646865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|2.89|5.89||There were no adjustments for multiple comparisons.|ANCOVA||Difference = Teriparatide minus Calcitonin|Null hypothesis=no difference between percentage changes from baseline in lumbar spine bone mineral density for female patients receiving teriparatide compared to female patients receiving calcitonin.||5.89|2.89|<0.0001
74047265|NCT00414973|147646866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.7||0.9062||95.0|-1.3|1.46|||ANCOVA||Difference = Teriparatide minus Calcitonin|||1.46|-1.30|0.9062
74047266|NCT00414973|147646867|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test|||||||<0.0001
74047267|NCT00414973|147646867|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 24 Percentage Change.|Wilcoxon Rank-Sum Test|||||||<0.0001
74047268|NCT00414973|147646868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.63|STANDARD_ERROR_OF_MEAN|2.2||0.2409||95.0|-1.87|7.13|||ANCOVA||Difference = Teriparatide minus Calcitonin|||7.13|-1.87|0.2409
74047269|NCT00414973|147646869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.96|STANDARD_ERROR_OF_MEAN|1.9||0.6156||95.0|-4.85|2.92|||ANCOVA||Difference = Teriparatide minus Calcitonin|||2.92|-4.85|0.6156
74047270|NCT00414973|147646870|SUPERIORITY_OR_OTHER|||||||0.0026||95.0||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test|||||||0.0026
74047271|NCT00414973|147646870|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||P-value for 24 Week Percentage Change.|Wilcoxon Rank-Sum Test|||||||0.0006
74047272|NCT03152110|147646895|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||||||.203
74047273|NCT03152110|147646896|SUPERIORITY|||||||0.931|||||||t-test, 2 sided|||||||0.931
74047274|NCT00850135|147646925|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED|||||p-Value for the correlation between AUC-110 and birth weight|correlation|||||||0.035
74047275|NCT00085644|147646973|SUPERIORITY_OR_OTHER||Risk Difference (RD)|37.6|||<|0.001||95.0|27.4|47.8|||Chi-squared||Risk difference is measured as a percentage.|ASAS 20 response rates of the adalimumab group were compared with the placebo group using Pearson's Chi-square test. The counts and percentages were calculated for total sample and by therapy group. Statistical tests were 2-sided. For the statistical analysis, subjects with missing data before Week 12 were considered as nonresponders. The comparisons were performed at an alpha level = 0.05.||47.8|27.4|< 0.001
74047276|NCT00085644|147646974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.985||95.0|||||ANCOVA|||||||0.985
74096802|NCT03433755|147742735|SUPERIORITY||Treatment difference|-42.74|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-48.06|-37.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-37.41|-48.06|< 0.0001
74096803|NCT03433755|147742735|SUPERIORITY||Treatment difference|-44.3|STANDARD_ERROR_OF_MEAN|2.38|<|0.0001|TWO_SIDED|95.0|-49.02|-39.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-39.58|-49.02|< 0.0001
74096804|NCT03433755|147742736|SUPERIORITY||Treatment difference|-43.05|STANDARD_ERROR_OF_MEAN|3.05|<|0.0001|TWO_SIDED|95.0|-49.09|-37.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-37.00|-49.09|< 0.0001
74096805|NCT03433755|147742736|SUPERIORITY||Treatment difference|-40.42|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-45.98|-34.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-34.87|-45.98|< 0.0001
74096806|NCT03433755|147742737|SUPERIORITY||Treatment difference|87.2|||<|0.0001|TWO_SIDED|95.0|72.6|92.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||92.8|72.6|< 0.0001
74096807|NCT03433755|147742737|SUPERIORITY||Treatment difference|91.5|||<|0.0001|TWO_SIDED|95.0|76.9|96.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||96.1|76.9|< 0.0001
74096808|NCT03433755|147742738|SUPERIORITY||Treatment difference|90.6|||<|0.0001|TWO_SIDED|95.0|76.6|95.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||95.6|76.6|< 0.0001
74096809|NCT03433755|147742738|SUPERIORITY||Treatment difference|85.7|||<|0.0001|TWO_SIDED|95.0|68.2|91.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||91.9|68.2|< 0.0001
73888089|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5||||0.3908|TWO_SIDED|95.0|-5.0|1.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.9|-5.0|0.3908
74047277|NCT01836029|147647056|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.266|ONE_SIDED|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank|||||1.22||0.266
74047278|NCT01836029|147647058|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.399|ONE_SIDED|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank|||||1.22||0.399
74047279|NCT01836029|147647059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.536||||||p-values are from Cochran-Mantel-Haenszel tests controlling for randomization stratification factors and comparing tumor response rates between the treatment groups.|Cochran-Mantel-Haenszel|||||||0.536
74047280|NCT04157751|147647071|OTHER||Stratified Win Ratio|1.36||||0.0027|TWO_SIDED|95.0|1.09|1.68||p-value for WR\<=1.0 (one-sided), variance calculated using the asymptotic normal U statistics approach.|Asymptotic normal U statistics approach||WR estimate= \[((a)+(c)+(e)+(g)) / ((b)+(d)+(f)+(h))\]|"Stratified win ratio (WR) was used, calculated as total number of wins in the empa group across all strata divided by total number of losses. Weights were applied analogous to a Mantel-Haenszel approach.~1. death in pbo first;~2. death in empa first;~3. HFEs in pbo more frequently;~4. HFEs in empa more frequently;~5. HFEs in pbo first;~6. HFEs in empa first;~7. KCCQ-TSS change lower in pbo;~8. KCCQ-TSS change lower in empa"||1.68|1.09|0.0027
74047281|NCT04157751|147647072|OTHER||Odds Ratio (OR)|1.522|STANDARD_ERROR_OF_MEAN|0.386||0.097|TWO_SIDED|95.0|0.927|2.501||p-value for OR=1.0 (two-sided).|Regression, Logistic|Wald Confidence interval.|Comparison vs. Placebo.|Logistic regression including terms for baseline KCCQ-TSS, treatment and heart failure status||2.501|0.927|0.0970
74096810|NCT03433755|147742739|SUPERIORITY||Treatment difference|87.0|||<|0.0001|TWO_SIDED|95.0|73.3|93.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||93.0|73.3|< 0.0001
74096811|NCT03433755|147742739|SUPERIORITY||Treatment difference|88.7|||<|0.0001|TWO_SIDED|95.0|73.5|94.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||94.0|73.5|< 0.0001
74096812|NCT03433755|147742740|SUPERIORITY||Treatment difference|82.8|||<|0.0001|TWO_SIDED|95.0|67.8|90.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||90.1|67.8|< 0.0001
74047282|NCT04157751|147647073|OTHER||Difference of adjusted mean|4.45|STANDARD_ERROR_OF_MEAN|2.1||0.0347|TWO_SIDED|95.0|0.32|8.59||p-value for difference = 0 (two-sided)|Mixed Models Analysis|||Restricted maximum likelihood estimation based on a mixed-effect model for repeated measures (MMRM) analysis to obtain adjusted means for the treatment effects. This model included discrete fixed effects for treatment group, and heart failure status at each visit and continuous fixed effects for baseline value at each visit. Missing data caused by patient withdrawal or other reasons were handled implicitly by the MMRM approach. Unstructured covariance structure was used.||8.59|0.32|0.0347
74047283|NCT04157751|147647074|OTHER||Adjusted geometric mean ratio|0.9||||0.0176|TWO_SIDED|95.0|0.82|0.98|||ANCOVA|ANCOVA with a discrete fixed effect for heart failure status and a continuous fixed effect for baseline NT-proBNP level.|Comparison vs. Placebo|Area under the curve (AUC) of change from baseline in log-transformed NT-proBNP level over 30 days of treatment was analysed by an analysis of covariance (ANCOVA). NT-proBNP level is regarded as log-normally distributed, therefore values were log-transformed prior to analysis. The linear trapezoidal rule was used to calculate the AUC after the log-transformation had been applied to each value.||0.98|0.82|0.0176
74047284|NCT04157751|147647077|OTHER||Hazard Ratio (HR)|0.71||||0.1241|TWO_SIDED|95.0|0.46|1.1||p-value for HR=1.0 (two sided)|Regression, Cox|Cox proportional hazard model with terms for heart failure status and treatment.|Comparison vs. Placebo.|||1.10|0.46|0.1241
74047285|NCT01302691|147647133|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.1||||0.205|TWO_SIDED|95.0|-2.7|0.6|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups||||0.6|-2.7|0.205
74047286|NCT01302691|147647139|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.2||||0.011|TWO_SIDED|95.0|-5.7|-0.8|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups||||-0.8|-5.7|0.011
74047287|NCT03446612|147647140|OTHER||FBF ratio difference|0.6953|STANDARD_DEVIATION|0.12998|||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (7.5 ug/min) is presented.|||||
74047288|NCT03446612|147647140|OTHER||FBF ratio difference|0.1683|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (15 ug/min) is presented.|||||
74047289|NCT03446612|147647140|OTHER||FBF ratio difference|0.3238|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (30 ug/min) is presented.|||||
74047290|NCT03446612|147647142|OTHER||FBF ratio difference|0.2968|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to sodium nitroprusside (3 ug/min) is presented.|||||
74047291|NCT03446612|147647142|OTHER||FBF ratio difference|1.4425|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to sodium nitroprusside (10 ug/min) is presented.|||||
74047292|NCT03446612|147647144|OTHER||FBF ratio difference|-0.1598|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to L-NMMA (2 umol/min) is presented.|||||
74047293|NCT03446612|147647144|OTHER||FBF ratio difference|-0.3715|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to L-NMMA (8 umol/min) is presented.|||||
74047294|NCT03934203|147647202|OTHER|The null hypothesis was 'The mean difference in the QTcF changes from baseline between 50 mg BI 409306 and placebo is greater than or equal to 10 milliseconds at least for one timepoint after dosing.' The one-sided tests were performed at the 5% level; due to the symmetry of the normal distribution 2-sided 90% confidence intervals for the differences of adjusted means per timepoint were used.|Difference of adjusted means|1.3|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|0.2|2.4|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 20 minutes after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||2.4|0.2|
74096813|NCT03433755|147742740|SUPERIORITY||Treatment difference|82.7|||<|0.0001|TWO_SIDED|95.0|64.8|89.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||89.7|64.8|< 0.0001
73880802|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9|TWO_SIDED|95.0|0.34|3.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.38|0.34|0.9000
74096814|NCT03433755|147742741|SUPERIORITY||Treatment difference|-48.45|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-57.78|-39.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-39.11|-57.78|< 0.0001
74018300|NCT01724528|147588144|SUPERIORITY_OR_OTHER||Relative risk|0.994||||1|TWO_SIDED|95.0|0.9691|1.0199|||Chi-squared|||||1.0199|0.9691|1.0000
74018301|NCT00466310|147588146|SUPERIORITY_OR_OTHER|||||||0.0149|TWO_SIDED|95.0||||Unadjusted p value is .0041|Wilcoxon (Mann-Whitney)|||A wilcoxon rank sum test was performed comparing baseline plasmalogen values, comparing schizophrenia subjects vs controls.P values from this analysis were adjusted for false discovery rates by the method of Storey and Tribshiani.||||0.0149
74018302|NCT04247425|147588228|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.59
74018303|NCT04247425|147588229|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.02
74018304|NCT04247425|147588230|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||1.0
74018305|NCT04247425|147588231|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.09
74018306|NCT00762515|147588251|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|baseline is used a factor||The null hypothesis states that there is no difference between groups.||||<0.05
74047295|NCT03934203|147647203|OTHER|The null hypothesis was 'The mean difference in the QTcF changes from baseline between 250 mg BI 409306 and placebo is greater than or equal to 10 milliseconds at least for one timepoint after dosing.' The one-sided tests were performed at the 5% level; due to the symmetry of the normal distribution 2-sided 90% confidence intervals for the differences of adjusted means per timepoint were used.|Difference of adjusted means|5.7|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|90.0|4.4|7.1|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 40 minutes after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||7.1|4.4|
74047296|NCT03934203|147647204|OTHER|No formal hypotheses were tested.|Difference of adjusted means|12.1|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|90.0|10.5|13.6|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as moxifloxacin - placebo at 1 hour and 30 minutes after drug intake.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||13.6|10.5|
74047297|NCT03934203|147647205|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 2 hours after drug administration.'|Difference of adjusted means|11.9|STANDARD_ERROR_OF_MEAN|0.9||0|TWO_SIDED|90.0|10.4|13.4||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.0167.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||13.4|10.4|0.00000000
74047298|NCT03934203|147647206|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 3 hours after drug administration.'|Difference of adjusted means|11.1|STANDARD_ERROR_OF_MEAN|1.0||3e-08|TWO_SIDED|90.0|9.3|12.8||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.0250.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.8|9.3|0.00000003
74047299|NCT03934203|147647207|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 4 hours after drug administration.'|Difference of adjusted means|10.7|STANDARD_ERROR_OF_MEAN|1.1||2e-07|TWO_SIDED|90.0|8.9|12.4||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.050.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.4|8.9|0.00000020
74096815|NCT03433755|147742741|SUPERIORITY||Treatment difference|-40.43|STANDARD_ERROR_OF_MEAN|4.13|<|0.0001|TWO_SIDED|95.0|-48.62|-32.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-32.24|-48.62|< 0.0001
74096816|NCT03433755|147742742|SUPERIORITY||Treatment difference|-44.7|STANDARD_ERROR_OF_MEAN|5.07|<|0.0001|TWO_SIDED|95.0|-54.76|-34.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-34.65|-54.76|< 0.0001
74096817|NCT03433755|147742742|SUPERIORITY||Treatment difference|-38.26|STANDARD_ERROR_OF_MEAN|5.88|<|0.0001|TWO_SIDED|95.0|-49.94|-26.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-26.59|-49.94|< 0.0001
74096818|NCT03433755|147742743|SUPERIORITY||Treatment difference|-15.09|STANDARD_ERROR_OF_MEAN|4.71||0.008|TWO_SIDED|95.0|-24.44|-5.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-5.75|-24.44|0.008
74096819|NCT03433755|147742743|SUPERIORITY||Treatment difference|-19.67|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-28.3|-11.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-11.05|-28.30|< 0.0001
74047300|NCT03934203|147647208|OTHER|No formal hypotheses were tested.|Difference of adjusted means|2.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|1.4|3.3|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 20 minutes after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||3.3|1.4|
74047301|NCT03934203|147647209|OTHER|No formal hypotheses were tested.|Difference of adjusted means|11.7|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|10.6|12.8|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 40 minutes after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.8|10.6|
74047302|NCT03934203|147647210|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.2|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.3|-0.1|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Minimum difference of adjusted means was calculated as BI 409306 - placebo at 24 hours after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||-0.1|-2.3|
74047303|NCT03934203|147647211|OTHER|No formal hypotheses were tested.|Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|90.0|-1.3|1.3|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Minimum difference of adjusted means was calculated as BI 409306 - placebo at 12 hours after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||1.3|-1.3|
74047304|NCT00608842|147647228|SUPERIORITY_OR_OTHER||Difference to placebo|0.0|||||TWO_SIDED|95.0|-18.4|20.4||||||Complete Clearance||20.4|-18.4|
74047305|NCT00608842|147647228|SUPERIORITY_OR_OTHER||Difference to placebo|0.0|||||TWO_SIDED|95.0|-18.4|20.4||||||Complete Clearance||20.4|-18.4|
74047306|NCT00608842|147647228|SUPERIORITY_OR_OTHER||Difference to placebo|7.1|||||TWO_SIDED|95.0|-12.2|31.5||||||Complete Clearance||31.5|-12.2|
74047307|NCT00608842|147647228|SUPERIORITY_OR_OTHER||Difference to placebo|1.6|||||TWO_SIDED|95.0|-23.0|27.5||||||≥ 75% Cleared||27.5|-23.0|
74047308|NCT00608842|147647228|SUPERIORITY_OR_OTHER||Difference to placebo|-5.1|||||TWO_SIDED|95.0|-28.3|19.6||||||≥ 75% Cleared||19.6|-28.3|
74047309|NCT00608842|147647228|SUPERIORITY_OR_OTHER||Difference to placebo|2.5|||||TWO_SIDED|95.0|-22.3|29.5||||||≥ 75% Cleared||29.5|-22.3|
74047310|NCT04445051|147647238|SUPERIORITY||Mean Difference (Final Values)|32.9||||0.01|TWO_SIDED|95.0|8.3|57.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||57.5|8.3|0.010
73880803|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7644|TWO_SIDED|95.0|0.39|3.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.64|0.39|0.7644
74047311|NCT04445051|147647238|SUPERIORITY||Mean Difference (Final Values)|34.3||||0.007|TWO_SIDED|95.0|9.8|58.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||58.8|9.8|0.007
74047312|NCT04445051|147647238|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.908|TWO_SIDED|95.0|-23.1|25.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||25.9|-23.1|0.908
74047313|NCT04445051|147647238|SUPERIORITY||Mean Difference (Final Values)|35.3||||0.006|TWO_SIDED|95.0|10.8|59.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||59.8|10.8|0.006
74047314|NCT04445051|147647238|SUPERIORITY||Mean Difference (Final Values)|36.8||||0.005|TWO_SIDED|95.0|11.9|61.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||61.8|11.9|0.005
74047315|NCT04445051|147647238|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.899|TWO_SIDED|95.0|-23.3|26.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||26.5|-23.3|0.899
74047316|NCT04445051|147647239|SUPERIORITY||Mean Difference (Final Values)|8.8||||0.665|TWO_SIDED|95.0|-31.9|49.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.6|-31.9|0.665
74047317|NCT04445051|147647239|SUPERIORITY||Mean Difference (Final Values)|-18.1||||0.375|TWO_SIDED|95.0|-58.7|22.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||22.4|-58.7|0.375
74047318|NCT04445051|147647239|SUPERIORITY||Mean Difference (Final Values)|-27.0||||0.188|TWO_SIDED|95.0|-67.6|13.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||13.6|-67.6|0.188
74047319|NCT04445051|147647239|SUPERIORITY||Mean Difference (Final Values)|-18.6||||0.361|TWO_SIDED|95.0|-59.3|21.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||21.9|-59.3|0.361
74047320|NCT04445051|147647239|SUPERIORITY||Mean Difference (Final Values)|-10.9||||0.6|TWO_SIDED|95.0|-52.3|30.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||30.5|-52.3|0.600
74047321|NCT04445051|147647239|SUPERIORITY||Mean Difference (Final Values)|7.78||||0.707|TWO_SIDED|95.0|-33.5|49.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.0|-33.5|0.707
74047322|NCT04445051|147647240|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.615|TWO_SIDED|95.0|-1.08|0.65||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.65|-1.08|0.615
74047323|NCT04445051|147647240|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.48|TWO_SIDED|95.0|-1.17|0.56||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.56|-1.17|0.480
74047324|NCT04445051|147647240|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.839|TWO_SIDED|95.0|-0.95|0.77||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.77|-0.95|0.839
74096820|NCT03433755|147742744|SUPERIORITY||Treatment difference|-17.56|STANDARD_ERROR_OF_MEAN|5.98||0.008|TWO_SIDED|95.0|-29.42|-5.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-5.69|-29.42|0.008
74096821|NCT03433755|147742744|SUPERIORITY||Treatment difference|-12.35|STANDARD_ERROR_OF_MEAN|5.38|<|0.0001|TWO_SIDED|95.0|-23.04|-1.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-1.67|-23.04|< 0.0001
74096822|NCT03433755|147742745|SUPERIORITY||Treatment difference|8.44|STANDARD_ERROR_OF_MEAN|2.56||0.008|TWO_SIDED|95.0|3.35|13.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||13.52|3.35|0.008
74096823|NCT03433755|147742745|SUPERIORITY||Treatment difference|6.8|STANDARD_ERROR_OF_MEAN|2.37||0.017|TWO_SIDED|95.0|2.1|11.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||11.50|2.10|0.017
74096824|NCT03433755|147742746|SUPERIORITY||Treatment difference|7.94|STANDARD_ERROR_OF_MEAN|2.91||0.008|TWO_SIDED|95.0|2.18|13.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||13.71|2.18|0.008
74096825|NCT03433755|147742746|SUPERIORITY||Treatment difference|6.17|STANDARD_ERROR_OF_MEAN|0.036||0.017|TWO_SIDED|95.0|0.42|11.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||11.92|0.42|0.017
74096826|NCT03433755|147742747|SUPERIORITY||Treatment difference|-22.96|STANDARD_ERROR_OF_MEAN|4.44||0.0002|TWO_SIDED|95.0|-33.12|-12.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-12.81|-33.12|0.0002
73880804|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.29||||0.2245|TWO_SIDED|95.0|0.6|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.67|0.60|0.2245
74018307|NCT00762515|147588252|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|baseline to be used a factor||The null hypothesis states that there is no difference between groups.||||<0.05
74018308|NCT01582308|147588264|SUPERIORITY_OR_OTHER||Least squares mean difference|18.24|||<|0.001|TWO_SIDED|90.0|14.97|21.67||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||21.67|14.97|<.001
74018309|NCT01582308|147588264|SUPERIORITY_OR_OTHER||Least squares mean difference|62.86|||<|0.001|TWO_SIDED|90.0|58.21|67.74||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||67.74|58.21|<.001
74018310|NCT01582308|147588264|SUPERIORITY_OR_OTHER||Least squares mean difference|1.11||||0.128|TWO_SIDED|90.0|-0.1|2.33||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||2.33|-0.10|0.128
74018311|NCT01582308|147588264|SUPERIORITY_OR_OTHER||Least squares mean difference|88.24|||<|0.001|TWO_SIDED|90.0|85.77|90.76||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||90.76|85.77|<.001
74018312|NCT01582308|147588264|SUPERIORITY_OR_OTHER||Least squares mean difference|44.62|||<|0.001|TWO_SIDED|90.0|34.51|55.23||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||55.23|34.51|<.001
74018313|NCT01582308|147588264|SUPERIORITY_OR_OTHER||Least squares mean difference|-17.13|||<|0.001|TWO_SIDED|90.0|-21.21|-13.25||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||-13.25|-21.21|<.001
74018314|NCT01582308|147588264|SUPERIORITY_OR_OTHER||Least squares mean difference|70.0|||<|0.001|TWO_SIDED|90.0|58.46|82.2||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||82.20|58.46|<.001
74018315|NCT01582308|147588264|SUPERIORITY_OR_OTHER||Least squares mean difference|-61.75|||<|0.001|TWO_SIDED|90.0|-68.76|-55.18||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||-55.18|-68.76|<.001
74018316|NCT01582308|147588264|SUPERIORITY_OR_OTHER||Least squares mean difference|25.38|||<|0.001|TWO_SIDED|90.0|15.37|35.48||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||35.48|15.37|<.001
74018317|NCT01582308|147588264|SUPERIORITY_OR_OTHER||Least squares mean difference|87.13|||<|0.001|TWO_SIDED|90.0|80.06|94.61||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||94.61|80.06|<.001
74018318|NCT01227902|147588302|SUPERIORITY_OR_OTHER||percentage of participants|40.0|||||TWO_SIDED|95.0|27.1|52.9|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||52.9|27.1|
74018319|NCT01227902|147588302|SUPERIORITY_OR_OTHER||percentage of participants|32.0|||||TWO_SIDED|95.0|19.1|44.9|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||44.9|19.1|
74047325|NCT04445051|147647240|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.894|TWO_SIDED|95.0|-0.92|0.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.80|-0.92|0.894
74047326|NCT04445051|147647240|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.195|TWO_SIDED|95.0|-1.46|0.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.30|-1.46|0.195
74047327|NCT04445051|147647240|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.242|TWO_SIDED|95.0|-1.4|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-1.40|0.242
74047328|NCT04445051|147647241|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.639|TWO_SIDED|95.0|-1.2|0.74||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.74|-1.20|0.639
74047329|NCT04445051|147647241|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.492|TWO_SIDED|95.0|-1.3|0.63||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.63|-1.30|0.492
74047330|NCT04445051|147647241|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.828|TWO_SIDED|95.0|-1.07|0.86||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.86|-1.07|0.828
74047331|NCT04445051|147647241|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.744|TWO_SIDED|95.0|-0.81|1.13||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.13|-0.81|0.744
74047332|NCT04445051|147647241|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.208|TWO_SIDED|95.0|-1.62|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-1.62|0.208
74047333|NCT04445051|147647241|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.116|TWO_SIDED|95.0|-1.77|0.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.20|-1.77|0.116
74047334|NCT04445051|147647242|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.798|TWO_SIDED|95.0|-0.75|0.96||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.96|-0.75|0.798
74047335|NCT04445051|147647242|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.556|TWO_SIDED|95.0|-1.1|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-1.10|0.556
74047336|NCT04445051|147647242|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.399|TWO_SIDED|95.0|-1.21|0.49||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.49|-1.21|0.399
74047337|NCT04445051|147647242|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.198|TWO_SIDED|95.0|-0.3|1.41||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.41|-0.30|0.198
74047338|NCT04445051|147647242|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.365|TWO_SIDED|95.0|-1.27|0.48||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.48|-1.27|0.365
74047339|NCT04445051|147647242|SUPERIORITY||Mean Difference (Final Values)|-0.95||||0.033|TWO_SIDED|95.0|-1.82|-0.08||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.08|-1.82|0.033
74018320|NCT01227902|147588302|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|95.0|35.2|64.8|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||64.8|35.2|
74018321|NCT01227902|147588302|SUPERIORITY_OR_OTHER||percentage of participants|56.9|||||TWO_SIDED|95.0|43.3|70.5|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||70.5|43.3|
74018322|NCT01227902|147588302|SUPERIORITY_OR_OTHER||percentage of participants|44.5|||||TWO_SIDED|95.0|37.6|51.4|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||51.4|37.6|
74018323|NCT01299766|147588358|SUPERIORITY||Risk Ratio (RR)|0.12||||0.02|TWO_SIDED|95.0|0.02|0.74|||Poisson regression with robust SE (GEE)|||Poisson regression with robust standard errors (GEE) was used to jointly model decline in HVLT-R Total Recall score ≥ 6 words at 6, 12, 18, and 24 months by treatment group. The model included time, treatment, time-by-treatment interaction terms, and baseline HVLT-R Total Recall score.||0.74|0.02|.02
74018324|NCT01299766|147588359|SUPERIORITY||Difference in Slopes|2.47||||0.064|TWO_SIDED|95.0|-0.14|5.07|||Mixed Models Analysis|||Mixed effects linear regression was used to model the trajectory. Fixed effects for time (as a continuous variable), treatment group, time-by-treatment group interaction, and age at baseline were included. Random intercepts and slopes were included to account for within-subject correlation.||5.07|-.14|.064
74018325|NCT00403260|147588366|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the PCR-corrected ACPR response rate at Day 28 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction). Non-inferiority of PA to MQ + AS was concluded if the lower limit of the CI for the difference was \>-5%.|ACPR percent difference|1.1||||0.106|TWO_SIDED|95.0|-0.2|3.1||If non-inferiority of PA was demonstrated, the p-value associated with a superiority test is calculated based on a 2-sided Chi-square test. If the calculated p-value is \<5%, then the superiority of PA compared to MQ+AS was statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than 5%.~Was tested versus the alternative:~Alternative hypothesis: the PCR-corrected ACPR response rate at Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than -5%."||3.1|-0.2|0.106
74018326|NCT01354028|147588374|SUPERIORITY_OR_OTHER|||||||0.1303||95.0|||||Chi-squared|Degrees of freedom =1||"Null hypothesis: there will be no difference in sleep efficiency in preterm infants on the day of massage versus the day without massage.~Power calculation: the sample size was determined by convenience for this pilot study"||||0.1303
74018327|NCT01354028|147588377|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||Pearson's chi square|Chi-squared|Degrees of freedom=1||"Null hypothesis: there is no difference in massage therapy or no massage therapy in number of infants who will be asleep at the end of massage or the corresponding time frame on the non massage day.~Pearson's chi square=4.98"||||0.026
74018328|NCT02109159|147588378|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.44|TWO_SIDED|95.0|0.8|1.4|||Chi-squared||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.|||1.4|0.8|0.44
74018329|NCT02109159|147588378|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.47|TWO_SIDED|95.0|0.8|1.7|||Chi-squared||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.|||1.7|0.8|0.47
74018330|NCT02109159|147588379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.|||0.04|-0.02|0.53
74018331|NCT02109159|147588379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.56|TWO_SIDED|95.0|-0.5|0.8|||t-test, 2 sided||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.|||0.8|-0.5|0.56
74018332|NCT01664793|147588384|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|Chi-square tests for comparisons of between-arm changes in vaccination rates from pre to post intervention.||||||<0.05
74018333|NCT03195517|147588386|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
74018334|NCT03195517|147588387|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
74018335|NCT03195517|147588388|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
74018336|NCT03195517|147588389|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
74018337|NCT03195517|147588390|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
74018338|NCT03195517|147588391|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
74018339|NCT03195517|147588392|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
74018340|NCT03195517|147588393|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
74018341|NCT03195517|147588394|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
74018342|NCT03195517|147588395|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
74018343|NCT00122135|147588446|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||||||.77
74018344|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.34|||||TWO_SIDED|90.0|66.05|149.43||||||Buprenorphine||149.43|66.05|
74018345|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|163.88|||||TWO_SIDED|90.0|110.82|242.34||||||Buprenorphine||242.34|110.82|
74018346|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|281.43|||||TWO_SIDED|90.0|187.1|423.33||||||Buprenorphine||423.33|187.10|
74018347|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.43|||||TWO_SIDED|90.0|52.14|117.98||||||Buprenorphine||117.98|52.14|
74018348|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|126.66|||||TWO_SIDED|90.0|81.87|195.97||||||Buprenorphine||195.97|81.87|
74018349|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|208.94|||||TWO_SIDED|90.0|137.21|318.18||||||Buprenorphine||318.18|137.21|
74018350|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|358.83|||||TWO_SIDED|90.0|231.92|555.17||||||Buprenorphine||555.17|231.92|
74047340|NCT04445051|147647243|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.882|TWO_SIDED|95.0|-0.83|0.96||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.96|-0.83|0.882
74096827|NCT03433755|147742747|SUPERIORITY||Treatment difference|-27.81|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|-36.6|-19.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-19.02|-36.60|< 0.0001
74096828|NCT03433755|147742748|SUPERIORITY||Treatment difference|-21.78|STANDARD_ERROR_OF_MEAN|6.32||0.0002|TWO_SIDED|95.0|-34.31|-9.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-9.25|-34.31|0.0002
73888090|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.2513|TWO_SIDED|95.0|-1.5|5.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.5|-1.5|0.2513
74047341|NCT04445051|147647243|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.478|TWO_SIDED|95.0|-1.21|0.57||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.57|-1.21|0.478
74047342|NCT04445051|147647243|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0.391|TWO_SIDED|95.0|-1.27|0.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.51|-1.27|0.391
74047343|NCT04445051|147647243|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.657|TWO_SIDED|95.0|-0.69|1.09||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.09|-0.69|0.657
74047344|NCT04445051|147647243|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.125|TWO_SIDED|95.0|-1.62|0.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.20|-1.62|0.125
74047345|NCT04445051|147647243|SUPERIORITY||Mean Difference (Final Values)|-0.91||||0.051|TWO_SIDED|95.0|-1.81|0.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.00|-1.81|0.051
74047346|NCT04445051|147647244|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.877|TWO_SIDED|95.0|-0.83|0.97||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.97|-0.83|0.877
74047347|NCT04445051|147647244|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.351|TWO_SIDED|95.0|-1.31|0.47||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.47|-1.31|0.351
74047348|NCT04445051|147647244|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.278|TWO_SIDED|95.0|-1.38|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-1.38|0.278
74047349|NCT04445051|147647244|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.711|TWO_SIDED|95.0|-0.73|1.06||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.06|-0.73|0.711
74047350|NCT04445051|147647244|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.024|TWO_SIDED|95.0|-1.97|-0.15||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.15|-1.97|0.024
74047351|NCT04445051|147647244|SUPERIORITY||Mean Difference (Final Values)|-1.23||||0.009|TWO_SIDED|95.0|-2.14|-0.31||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.31|-2.14|0.009
74047352|NCT00997555|147647261|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Chi-squared|||||||0.6
74047353|NCT00997555|147647262|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||(bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).|t-test, 2 sided|||||||0.7
74047354|NCT00997555|147647263|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|(bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).||||||0.4
74047355|NCT00997555|147647264|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||t-test, 2 sided|(bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).||||||0.5
74047356|NCT03028467|147647284|OTHER||Mean Difference (Net)|-1.111|||||TWO_SIDED|95.0|-2.7186|0.4965|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.4965|-2.7186|
73880805|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0475|TWO_SIDED|95.0|1.02|27.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||27.40|1.02|0.0475
74047357|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.5177|||||TWO_SIDED|95.0|-1.904|0.8685|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8685|-1.9040|
74047358|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.5332|||||TWO_SIDED|95.0|-1.914|0.8475|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8475|-1.9140|
74047359|NCT03028467|147647284|OTHER||Mean Difference (Net)|-1.1387|||||TWO_SIDED|95.0|-2.8848|0.6075|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6075|-2.8848|
74047360|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.8905|||||TWO_SIDED|95.0|-2.3962|0.6153|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6153|-2.3962|
74047361|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.8047|||||TWO_SIDED|95.0|-2.3045|0.6951|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6951|-2.3045|
74047362|NCT03028467|147647284|OTHER||Mean Difference (Net)|-1.4575|||||TWO_SIDED|95.0|-3.6013|0.6863|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6863|-3.6013|
74047363|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.8894|||||TWO_SIDED|95.0|-2.7381|0.9593|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.9593|-2.7381|
74047364|NCT03028467|147647284|OTHER||Mean Difference (Net)|-1.1615|||||TWO_SIDED|95.0|-3.0028|0.6799|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6799|-3.0028|
74047365|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.3209|||||TWO_SIDED|95.0|-2.3021|1.6603|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.6603|-2.3021|
74047366|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.1876|||||TWO_SIDED|95.0|-1.896|1.5209|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.5209|-1.8960|
73880806|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2569|TWO_SIDED|95.0|0.57|8.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.07|0.57|0.2569
74047367|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.4593|||||TWO_SIDED|95.0|-2.161|1.2424|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.2424|-2.1610|
74047368|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.6521|||||TWO_SIDED|95.0|-3.1342|1.83|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.8300|-3.1342|
74047369|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.5499|||||TWO_SIDED|95.0|-2.6903|1.5904|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.5904|-2.6903|
74047370|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.9665|||||TWO_SIDED|95.0|-3.0984|1.1654|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.1654|-3.0984|
74047371|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.3576|||||TWO_SIDED|95.0|-3.0892|2.374|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.3740|-3.0892|
74047372|NCT03028467|147647284|OTHER||Mean Difference (Net)|0.1851|||||TWO_SIDED|95.0|-2.1704|2.5407|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.5407|-2.1704|
74047373|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.1181|||||TWO_SIDED|95.0|-2.4643|2.2281|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.2281|-2.4643|
74047374|NCT03028467|147647284|OTHER||Mean Difference (Net)|-1.4276|||||TWO_SIDED|95.0|-3.6569|0.8018|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8018|-3.6569|
74047375|NCT03028467|147647284|OTHER||Mean Difference (Net)|0.5415|||||TWO_SIDED|95.0|-1.381|2.4639|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.4639|-1.3810|
73880807|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|9.32||||0.0412|TWO_SIDED|95.0|1.09|79.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||79.44|1.09|0.0412
74047376|NCT03028467|147647284|OTHER||Mean Difference (Net)|-0.7932|||||TWO_SIDED|95.0|-2.708|1.1217|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.1217|-2.7080|
74047377|NCT04757376|147647286|EQUIVALENCE|Statistical equivalence: the 90% confidence interval (CI) of the difference in the mean of the primary efficacy endpoint between treatment groups was entirely within an equivalence margin, \[- 1.45, + 1.45\].|Mean Difference (Final Values)|-0.19|||||TWO_SIDED|90.0|-0.76|0.38|||ANCOVA|ANCOVA included the treatment as a fixed effect and age, baseline LS-BMD T-score, and prior bisphosphonates therapy (Yes versus No) as covariates.||||0.38|-0.76|
74047378|NCT01307046|147647300|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-5.1|||<|0.001|TWO_SIDED|95.0|-6.8|-3.4|||constrained longitudinal data analysis|||||-3.4|-6.8|<.001
74047379|NCT01307046|147647301|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-9.2|||<|0.001|TWO_SIDED|95.0|-11.9|-6.5|||constrained longitudinal data analysis|||||-6.5|-11.9|<.001
74047380|NCT02550093|147647303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||HEAT||||.47
74047381|NCT02550093|147647303|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.70
74047382|NCT02550093|147647304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||HEAT||||0.84
74047383|NCT02550093|147647304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.95
74047384|NCT02550093|147647305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||HEAT||||0.92
74047385|NCT02550093|147647305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.63
74047386|NCT02550093|147647306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
74047387|NCT02550093|147647307|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
74047388|NCT02550093|147647308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
74047389|NCT02550093|147647309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
74047390|NCT02550093|147647310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
74047391|NCT02550093|147647311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
74047392|NCT02550093|147647312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
74047393|NCT02550093|147647313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
74047394|NCT02550093|147647314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
74047395|NCT01365091|147647315|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1: The corresponding power and coefficient of variation between test and reference drugs are 98% and 17.24%, respectively|Geometric mean ratio|95.204|||||TWO_SIDED|90.0|87.618|103.446|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.446|87.618|
74047396|NCT01365091|147647315|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and coefficient of variation are 80% and 22.62%, respectively.|Geometric mean ratio|107.606|||||TWO_SIDED|90.0|96.552|119.924|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||119.924|96.552|
74047397|NCT01365091|147647315|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 16.26%, respectively.|Geometric mean ratio|104.373|||||TWO_SIDED|90.0|96.504|112.883|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B= FDC (test value)|||112.883|96.504|
74047398|NCT01365091|147647315|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 81% and 14.42%,respectively.|Geometric mean ratio|88.188|||||TWO_SIDED|90.0|82.368|94.419|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||94.419|82.368|
74047399|NCT01365091|147647315|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 13.09%, respectively.|Geometric mean ratio|98.168|||||TWO_SIDED|90.0|92.263|104.451|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.451|92.263|
74047400|NCT01365091|147647315|NON_INFERIORITY_OR_EQUIVALENCE|5-OH saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 8.02%, respectively.|Geometric mean ratio|95.023|||||TWO_SIDED|90.0|91.47|98.714|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.714|91.470|
74047401|NCT01365091|147647315|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 15.55%, respectively.|Geometric mean ratio|97.601|||||TWO_SIDED|90.0|15.55|99.0|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99|15.55|
74047402|NCT01365091|147647315|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 84% and 15.65%, respectively.|Geometric mean ratio|110.656|||||TWO_SIDED|90.0|102.416|119.559|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||119.559|102.416|
74047403|NCT01365091|147647315|NON_INFERIORITY_OR_EQUIVALENCE|OH-Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.61%, respectively.|Geometric mean ratio|106.264|||||TWO_SIDED|90.0|99.826|113.117|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||113.117|99.826|
74047404|NCT01365091|147647315|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.30%, respectively.|Geometric mean ratio|100.028|||||TWO_SIDED|90.0|95.164|105.139|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||105.139|95.164|
74047405|NCT01365091|147647315|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.38%, respectively.|Geometric mean ratio|93.644|||||TWO_SIDED|95.0|89.055|98.47|||ANCOVA|Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.470|89.055|
74047406|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1: The corresponding power and coefficient of variation are 98% and 17.24%, respectively.|Geometric mean ratio|91.508|||||TWO_SIDED|90.0|82.596|101.38|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.380|82.596|
74096829|NCT03433755|147742748|SUPERIORITY||Treatment difference|-15.74|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|95.0|-26.31|-5.18||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-5.18|-26.31|< 0.0001
74096830|NCT01565850|147742749|NON_INFERIORITY_OR_EQUIVALENCE|A total sample size of 150 HIV-1 infected participants, randomized in a 2:1 ratio to 2 groups, would achieve 56% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 0.88 for both arms, a noninferiority margin of 0.12, and the significance level of the test at a one-sided 0.025 level were assumed.|Difference in proportions|3.3||||0.64|TWO_SIDED|95.0|-11.4|18.1||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 24; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.||18.1|-11.4|0.64
74096831|NCT01565850|147742750|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.|Difference in proportions|-6.2||||0.35|TWO_SIDED|95.0|-19.9|7.4||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.|||7.4|-19.9|0.35
74096832|NCT01565850|147742751|SUPERIORITY_OR_OTHER||Difference in LSM|0.04||||0.67|TWO_SIDED|95.0|-0.14|0.21||The p-value, difference in least squares mean (LSM), and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||0.21|-0.14|0.67
74096833|NCT01565850|147742752|SUPERIORITY_OR_OTHER||Difference in LSM|0.06||||0.5|TWO_SIDED|95.0|-0.11|0.23||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||0.23|-0.11|0.50
74096834|NCT01565850|147742753|SUPERIORITY_OR_OTHER||Difference in LSM|45.0||||0.11|TWO_SIDED|95.0|-10.0|101.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||101|-10|0.11
74096835|NCT01565850|147742754|SUPERIORITY_OR_OTHER||Difference in LSM|18.0||||0.5|TWO_SIDED|95.0|-35.0|72.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||72|-35|0.50
74096836|NCT04994483|147742769|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.4308|TWO_SIDED|95.0|-1.37|0.59|||Mixed Models Analysis|||||0.59|-1.37|0.4308
74096837|NCT04994483|147742770|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.4034|TWO_SIDED|95.0|-0.68|1.7|||Mixed Models Analysis|||||1.70|-0.68|0.4034
74096838|NCT00191113|147742784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001||95.0|0.7|1.1|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interaction terms removed when not significant.|"Effect direction is As-Randomized Humatrope minus As-Randomized Control"|This component of the primary analysis is inferential i.e. to ascertain definitively whether Humatrope treatment affects change in Height SDS (NCHS). Null hypothesis is no effect of Humatrope treatment.||1.1|0.7|<0.001
74096839|NCT00191113|147742785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.001||95.0|0.9|1.2|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interactions terms removed when not significant.|"Effect direction is As-Treated Growth Hormone minus As-Treated No Growth Hormone"|Estimation analysis of the magnitude of effect of treatment with growth hormone upon Final Height. Null hypothesis is no effect of growth hormone upon attained height standard deviation score (National Center for Health Statistics).||1.2|0.9|<0.001
74047407|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.66%, respectively.|Geometric mean ratio|97.437|||||TWO_SIDED|90.0|93.889|101.119|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.119|93.889|
74047408|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.43%, respectively.|Geometric mean ratio|96.77|||||TWO_SIDED|90.0|93.35|100.316|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.316|93.350|
74096840|NCT00191113|147742786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||<|0.001||95.0|0.9|1.3|||ANCOVA|||||1.3|0.9|<0.001
74096841|NCT00191113|147742787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9|||<|0.001||95.0|5.7|8.1|||ANCOVA|||||8.1|5.7|<0.001
74096842|NCT00191113|147742788|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
74096843|NCT00191113|147742789|SUPERIORITY_OR_OTHER|||||||0.744||95.0|||||Fisher Exact|||||||0.744
74047409|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.37%, respectively.|Geometric mean ratio|91.585|||||TWO_SIDED|90.0|85.56|98.035|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.035|85.56|
74047410|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 96.028% and 101.095%, respectively.|Geometric mean ratio|98.529|||||TWO_SIDED|90.0|96.028|101.095|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.095|96.028|
74047411|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.55%, respectively|Geometric mean ratio|96.239|||||TWO_SIDED|90.0|93.286|99.286|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99.286|93.286|
74047412|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.19%, respectively.|Geometric mean ratio|102.994|||||TWO_SIDED|90.0|96.956|109.407|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||109.407|96.956|
74047413|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.135|||||TWO_SIDED|95.0|93.778|100.613|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.613|93.778|
74047414|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.18%, respectively.|Geometric mean ratio|100.01|||||TWO_SIDED|90.0|96.512|103.648|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.648|96.512|
74047415|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1:The corresponding power and the variation coefficient are 93% and 17.35%, respectively.|Geometric mean ratio|92.953|||||TWO_SIDED|90.0|85.502|101.053|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.053|85.502|
74047416|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.75%, respectively.|Geometric mean ratio|101.281|||||TWO_SIDED|95.0|98.494|104.147|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.147|98.494|
74047417|NCT01365091|147647316|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.73%, respectively.|Geometric mean ratio|100.111|||||TWO_SIDED|90.0|97.367|102.932|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||102.932|97.367|
74047418|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|For AUC(0-inf) metformin, Arm 1, the corresponding power and coefficient of variation are 80% and 21.06%, respectively.|Geometric mean ratio|91.494|||||TWO_SIDED|90.0|82.697|101.226|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).|||101.226|82.697|
74047419|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.60%, respectively.|Geometric mean ratio|97.477|||||TWO_SIDED|90.0|93.955|101.132|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.132|93.955|
74047420|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1. The corresponding power and the coefficient of variation are 99% and 07.31%, respectively.|Geometric mean ratio|96.76|||||TWO_SIDED|90.0|93.393|100.247|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).|||100.247|93.393|
74047421|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.25%, respectively.|Geometric mean ratio|91.548|||||TWO_SIDED|90.0|85.573|97.939|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||97.939|85.573|
74018351|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.09|||||TWO_SIDED|90.0|44.03|138.49||||||Norbuprenorphine||138.49|44.03|
74096844|NCT00191113|147742790|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||Fisher Exact|||||||0.073
74096845|NCT00191113|147742791|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||Comparison of proportion of patients with any category of hearing loss between As-Treated Growth Hormone group and As-Treated No Growth Hormone.||||>0.999
74018352|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|74.78|||||TWO_SIDED|90.0|39.26|142.41||||||Norbuprenorphine||142.41|39.26|
74018353|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|11.45|||||TWO_SIDED|90.0|6.35|20.66||||||Norbuprenorphine||20.66|6.35|
74018354|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|71.08|||||TWO_SIDED|90.0|39.0|129.49||||||Norbuprenorphine||129.49|39.00|
74018355|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|109.9|||||TWO_SIDED|90.0|58.14|207.75||||||Norbuprenorphine||207.75|58.14|
74018356|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|105.23|||||TWO_SIDED|90.0|52.17|212.24||||||Norbuprenorphine||212.24|52.17|
74018357|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|16.12|||||TWO_SIDED|90.0|8.4|30.94||||||Norbuprenorphine||30.94|8.40|
74018358|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|79.3|||||TWO_SIDED|90.0|40.03|157.12||||||Naloxone||157.12|40.03|
74018359|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|317.58|||||TWO_SIDED|90.0|164.93|611.54||||||Naloxone||611.54|164.93|
74018360|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1401.85|||||TWO_SIDED|90.0|707.55|2777.46||||||Naloxone||2777.46|707.55|
74018361|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|105.78|||||TWO_SIDED|90.0|53.39|209.59||||||Naloxone||209.59|53.39|
74018362|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|74.97|||||TWO_SIDED|90.0|36.09|155.71||||||Naloxone||155.71|36.09|
74018363|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|300.22|||||TWO_SIDED|90.0|148.44|607.21||||||Naloxone||607.21|148.44|
74018364|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1325.22|||||TWO_SIDED|90.0|638.03|2752.55||||||Naloxone||2752.55|638.03|
74018365|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|85.87|||||TWO_SIDED|90.0|66.06|111.61||||||Naloxone-3-β-D-Glucuronide||111.61|66.06|
74047422|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 5.38%,respectively.|Geometric mean ratio|98.535|||||TWO_SIDED|95.0|96.044|101.09|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.090|96.044|
74047423|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.52%, respectively.|Geometric mean ratio|96.258|||||TWO_SIDED|95.0|93.319|99.29|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99.290|93.319|
74047424|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 11.75%, respectively.|Geometric mean ratio|102.383|||||TWO_SIDED|95.0|96.589|108.525|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||108.525|96.589|
74047425|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 5: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.187|||||TWO_SIDED|90.0|93.832|100.662|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.662|93.832|
74047426|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Sarexagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.08%, respectively.|Geometric mean ratio|100.015|||||TWO_SIDED|95.0|96.56|103.594|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.594|96.560|
74047427|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 4: The corresponding power and the variation coefficient are 94% and 17.13%, respectively.|Geometric mean ratio|93.219|||||TWO_SIDED|90.0|85.835|101.238|||ANCOVA|||||101.238|85.835|
73880808|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1201|TWO_SIDED|95.0|0.76|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.61|0.76|0.1201
73880809|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3814|TWO_SIDED|95.0|0.53|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.23|0.53|0.3814
73888091|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2||||0.5035|TWO_SIDED|95.0|-4.6|2.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-4.6|0.5035
74047428|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.72%, respectively.|Geometric mean ratio|101.346|||||TWO_SIDED|90.0|98.574|104.196|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.196|98.574|
74047429|NCT01365091|147647318|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.71%, respectively.|Geometric mean ratio|100.056|||||TWO_SIDED|90.0|97.324|102.864|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||102.864|97.324|
74047430|NCT03227224|147647342|SUPERIORITY||Difference of Least Square Means|0.9||||0.724|TWO_SIDED|90.0|-3.12|4.82|||Mixed model for repeated measures (MMRM)|||||4.82|-3.12|0.724
74047431|NCT03227224|147647342|SUPERIORITY||Difference of Least Square Means|-3.1||||0.083|TWO_SIDED|90.0|-6.13|-0.16|||MMRM|||||-0.16|-6.13|0.083
73880810|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8549|TWO_SIDED|95.0|0.38|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.23|0.38|0.8549
73880811|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.77||||0.1274|TWO_SIDED|95.0|0.75|10.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.24|0.75|0.1274
73880812|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0703|TWO_SIDED|95.0|0.9|15.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.01|0.90|0.0703
73880813|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1821|TWO_SIDED|95.0|0.66|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.76|0.66|0.1821
73880814|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|12.96||||0.0187|TWO_SIDED|95.0|1.53|109.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||109.5|1.53|0.0187
73880815|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0458|TWO_SIDED|95.0|1.03|17.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||17.00|1.03|0.0458
73880816|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6806|TWO_SIDED|95.0|0.41|3.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.89|0.41|0.6806
73880817|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.15||||0.809|TWO_SIDED|95.0|0.38|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.45|0.38|0.8090
73880818|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.22||||0.2352|TWO_SIDED|95.0|0.6|8.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.26|0.60|0.2352
73880819|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.04||||0.1231|TWO_SIDED|95.0|0.74|12.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.50|0.74|0.1231
73880820|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.86||||0.1445|TWO_SIDED|95.0|0.7|11.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||11.76|0.70|0.1445
74096846|NCT00191113|147742792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.492||||0.419||95.0|-8.631|3.646|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control|||3.646|-8.631|0.419
74096847|NCT00191113|147742794|SUPERIORITY_OR_OTHER|||||||0.545||95.0|||||Fisher Exact|||||||0.545
73880821|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|12.03||||0.023|TWO_SIDED|95.0|1.41|102.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||102.7|1.41|0.0230
73880822|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0801|TWO_SIDED|95.0|0.86|14.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||14.36|0.86|0.0801
73880823|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.63||||0.4152|TWO_SIDED|95.0|0.5|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.32|0.50|0.4152
74018366|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|123.77|||||TWO_SIDED|90.0|96.27|159.13||||||Naloxone-3-β-D-Glucuronide||159.13|96.27|
74018367|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|91.26|||||TWO_SIDED|90.0|70.21|118.62||||||Naloxone-3-β-D-Glucuronide||118.62|70.21|
74018368|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|84.78|||||TWO_SIDED|90.0|65.23|110.2||||||Naloxone-3-β-D-Glucuronide||110.20|65.23|
74018369|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|101.28|||||TWO_SIDED|90.0|76.52|134.06||||||Naloxone-3-β-D-Glucuronide||134.06|76.52|
74018370|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|145.99|||||TWO_SIDED|90.0|111.43|191.26||||||Naloxone-3-β-D-Glucuronide||191.26|111.43|
74018371|NCT01846455|147588447|SUPERIORITY_OR_OTHER||ratio of parameter means, %|107.64|||||TWO_SIDED|90.0|81.33|142.47||||||Naloxone-3-β-D-Glucuronide||142.47|81.33|
74096848|NCT00191113|147742796|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
74096849|NCT00191113|147742798|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
74096850|NCT00191113|147742799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.945||95.0|-0.199|0.186|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control|||0.186|-0.199|0.945
74047432|NCT03227224|147647342|SUPERIORITY||Difference of Least Square Means|-1.5||||0.424|TWO_SIDED|90.0|-4.7|1.63|||MMRM|||||1.63|-4.70|0.424
74096851|NCT00191113|147742801|SUPERIORITY_OR_OTHER|||||||||95.0||||P-value cannot be computed since no patients had abnormal result in either comparison group.|Fisher Exact|||||||
74096852|NCT01404923|147742803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4||||0.0008|TWO_SIDED||||||ANCOVA|||||||0.0008
74047433|NCT03782376|147647423|SUPERIORITY||Difference in percentage|11.5||||0.089|TWO_SIDED|95.0|-1.5|24.5||Threshold for significance was 0.05 level.|Cochran-Mantel Haenszel-chi-square test|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||24.5|-1.5|0.089
74047434|NCT03782376|147647424|SUPERIORITY||Difference in percentage|5.9||||0.338|TWO_SIDED|95.0|-6.0|17.8|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||17.8|-6.0|0.338
74047435|NCT03782376|147647425|SUPERIORITY||Difference in percentage|7.1||||0.3|TWO_SIDED|95.0|-6.0|20.2|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||20.2|-6.0|0.300
74047436|NCT03782376|147647426|SUPERIORITY||Difference in percentage|6.4||||0.314|TWO_SIDED|95.0|-5.8|18.6|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||18.6|-5.8|0.314
74047437|NCT03782376|147647427|SUPERIORITY||Difference in percentage|18.5||||0.004|TWO_SIDED|95.0|6.8|30.2|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||30.2|6.8|0.004
74047438|NCT00400946|147647452|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||.60
74047439|NCT05426460|147647481|SUPERIORITY|||||||0.438|||||||ANOVA|||2 x 2 ANOVA||||.438
74047440|NCT05426460|147647482|SUPERIORITY|||||||0.847|||||||ANOVA|||2 x 2 ANOVA||||.847
74047441|NCT05426460|147647483|SUPERIORITY|||||||0.57|||||||ANOVA|||2 X 2 ANOVA||||.570
74047442|NCT05426460|147647484|SUPERIORITY|||||||0.657|||||||ANOVA|||2 x 2 ANOVA||||.657
74096853|NCT00368979|147742845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.003||95.0|-2.7|-0.5|||ANCOVA|||||-0.5|-2.7|0.003
74047443|NCT05426460|147647485|SUPERIORITY|||||||0.254|||||||ANOVA|||2 x 2 ANOVA||||.254
74047444|NCT05426460|147647486|SUPERIORITY|||||||0.852|||||||ANOVA|||2 x 2 ANOVA with Main effect p-values for tDCS and AAT reported in comments below||||.852
74047445|NCT05426460|147647487|SUPERIORITY|||||||0.732|||||||ANOVA|||2 x 2 ANOVA||||.732
74047446|NCT05426460|147647488|SUPERIORITY|||||||0.038|||||||ANOVA|||2 x 2 ANOVA||||.038
74047447|NCT05426460|147647489|SUPERIORITY|||||||0.029|||||||ANOVA|||2 x 2 ANOVA||||.029
74047448|NCT05426460|147647490|SUPERIORITY|||||||0.353|||||||ANOVA|||2 x 2 ANOVA||||.353
74047449|NCT01431521|147647494|SUPERIORITY_OR_OTHER||Least squares mean difference|-44.37|||<|0.001|TWO_SIDED|95.0|-54.67|-34.07|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-34.07|-54.67|<0.001
74047450|NCT01431521|147647494|SUPERIORITY_OR_OTHER||Least squares mean difference|-26.67|||<|0.001|TWO_SIDED|95.0|-36.97|-16.37|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-16.37|-36.97|<0.001
74096854|NCT02684630|147742850|OTHER|A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|||0.951|
74096855|NCT02684630|147742851|OTHER|A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|||0.951|
74047451|NCT01431521|147647494|SUPERIORITY_OR_OTHER||least squares mean difference|-17.69||||0.007|TWO_SIDED|95.0|-36.97|-7.39|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-7.39|-36.97|0.007
74047452|NCT01431521|147647495|SUPERIORITY_OR_OTHER||Least square mean difference|-6.35|||>|0.2|TWO_SIDED|95.0|-18.69|6.0|||Linear mixed effect model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||6.00|-18.69|>0.200
74047453|NCT01431521|147647495|SUPERIORITY_OR_OTHER||Least squares mean difference|-16.74||||0.028|TWO_SIDED|95.0|-29.08|-4.4|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||-4.40|-29.08|0.028
74047454|NCT01431521|147647496|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.47|||>|0.2|TWO_SIDED|95.0|-17.85|10.92|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||10.92|-17.85|>0.200
74047455|NCT01431521|147647496|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.67|||>|0.2|TWO_SIDED|95.0|-25.06|3.71|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||3.71|-25.06|>0.200
74047456|NCT05171816|147647501|OTHER|Exploratory|Hazard Ratio (HR)|1.43||||0.2592|TWO_SIDED|95.0|0.83|2.48||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.48|0.83|0.2592
73880824|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.7||||0.3845|TWO_SIDED|95.0|0.51|5.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.65|0.51|0.3845
73880825|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1864|TWO_SIDED|95.0|0.65|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.39|0.65|0.1864
73880826|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.06||||0.01268|TWO_SIDED|95.0|0.73|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.86|0.73|0.01268
73880827|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.8||||0.16|TWO_SIDED|95.0|0.67|11.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.76|0.67|0.1600
73880828|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|6.13||||0.0317|TWO_SIDED|95.0|1.17|32.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||32.11|1.17|0.0317
74096856|NCT00631657|147742852|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|48.7|||<|0.0001|TWO_SIDED|95.0|35.0|62.5|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline TST as covariate.|||62.5|35.0|<0.0001
74096857|NCT00631657|147742855|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.9||||0.2145|TWO_SIDED|95.0|-12.6|2.8|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline SL as covariate.|||2.8|-12.6|0.2145
73880829|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0709|TWO_SIDED|95.0|0.89|15.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||15.53|0.89|0.0709
73880830|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.6||||0.4533|TWO_SIDED|95.0|0.47|5.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.41|0.47|0.4533
73880831|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7053|TWO_SIDED|95.0|0.24|2.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.60|0.24|0.7053
74018372|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|120.02|||||TWO_SIDED|90.0|83.35|172.82||||||Buprenorphine||172.82|83.35|
74018373|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|107.85|||||TWO_SIDED|90.0|75.85|153.36||||||Buprenorphine||153.36|75.85|
74018374|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|171.76|||||TWO_SIDED|90.0|117.93|250.15||||||Buprenorphine||250.15|117.93|
74018375|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|112.82|||||TWO_SIDED|90.0|77.66|163.91||||||Buprenorphine||163.91|77.66|
74018376|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|106.38|||||TWO_SIDED|90.0|71.43|158.43||||||Buprenorphine||158.43|71.43|
74018377|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|95.59|||||TWO_SIDED|90.0|64.36|141.99||||||Buprenorphine||141.99|64.36|
74018378|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|152.24|||||TWO_SIDED|90.0|103.08|224.83||||||Buprenorphine||224.83|103.08|
74018379|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|135.17|||||TWO_SIDED|90.0|75.44|242.16||||||Norbuprenorphine||242.16|75.44|
74018380|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|67.87|||||TWO_SIDED|90.0|38.82|118.68||||||Norbuprenorphine||118.68|38.82|
74018381|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|48.39|||||TWO_SIDED|90.0|27.01|86.69||||||Norbuprenorphine||86.69|27.01|
74018382|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|76.59|||||TWO_SIDED|90.0|42.75|137.22||||||Norbuprenorphine||137.22|42.75|
74018383|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|176.48|||||TWO_SIDED|90.0|94.62|329.17||||||Norbuprenorphine||329.17|94.62|
74018384|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|88.62|||||TWO_SIDED|90.0|48.6|161.59||||||Norbuprenorphine||161.59|48.60|
74018385|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|63.17|||||TWO_SIDED|90.0|33.87|117.83||||||Norbuprenorphine||117.83|33.87|
74018386|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|100.41|||||TWO_SIDED|90.0|51.3|196.53||||||Naloxone||196.53|51.30|
74018387|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|270.0|||||TWO_SIDED|90.0|141.86|513.9||||||Naloxone||513.90|141.86|
74018388|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1129.81|||||TWO_SIDED|90.0|577.22|2211.44||||||Naloxone||2211.44|577.22|
74018389|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|126.25|||||TWO_SIDED|90.0|64.5|247.11||||||Naloxone||247.11|64.50|
74018390|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|79.53|||||TWO_SIDED|90.0|38.79|163.06||||||Naloxone||163.06|38.79|
74018391|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|213.86|||||TWO_SIDED|90.0|107.07|427.17||||||Naloxone||427.17|107.07|
74018392|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|894.91|||||TWO_SIDED|90.0|436.49|1834.8||||||Naloxone||1834.80|436.49|
74018393|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|111.03|||||TWO_SIDED|90.0|85.94|143.44||||||Naloxone-3-β-D-Glucuronide||143.44|85.94|
74018394|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|111.22|||||TWO_SIDED|90.0|87.02|142.16||||||Naloxone-3-β-D-Glucuronide||142.16|87.02|
73880832|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3677|TWO_SIDED|95.0|0.49|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.99|0.49|0.3677
73880833|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.24||||0.735|TWO_SIDED|95.0|0.35|4.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.40|0.35|0.7350
73880834|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.37||||0.6443|TWO_SIDED|95.0|0.36|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.15|0.36|0.6443
73880835|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4865|TWO_SIDED|95.0|0.43|5.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.76|0.43|0.4865
73880836|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.52||||0.1628|TWO_SIDED|95.0|0.69|9.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.27|0.69|0.1628
74096858|NCT00631657|147742856|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.0|||<|0.0001|TWO_SIDED|95.0|-34.5|-15.4|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline WASO as covariate.|||-15.4|-34.5|<0.0001
74096859|NCT00325195|147742863|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
74096860|NCT00325195|147742863|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
74096861|NCT00325195|147742864|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||Fisher Exact|||||||<0.002
74096862|NCT00325195|147742864|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.200
74096863|NCT00325195|147742865|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Fisher Exact|||% of pegloticase q2 participants reporting flares compared to placebo pts during Months 4-6 treatment period||||0.007
73880837|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|0.79||||0.6935|TWO_SIDED|95.0|0.24|2.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.57|0.24|0.6935
73880838|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9753|TWO_SIDED|95.0|0.32|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.28|0.32|0.9753
74018395|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|83.09|||||TWO_SIDED|90.0|64.32|107.35||||||Naloxone-3-β-D-Glucuronide||107.35|64.32|
74018396|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|83.66|||||TWO_SIDED|90.0|64.75|108.08||||||Naloxone-3-β-D-Glucuronide||108.08|64.75|
74018397|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.72|||||TWO_SIDED|90.0|100.93|174.53||||||Naloxone-3-β-D-Glucuronide||174.53|100.93|
74018398|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.95|||||TWO_SIDED|90.0|102.12|173.1||||||Naloxone-3-β-D-Glucuronide||173.10|102.12|
74018399|NCT01846455|147588448|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.33|||||TWO_SIDED|90.0|75.54|130.61||||||Naloxone-3-β-D-Glucuronide||130.61|75.54|
74018400|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|125.19|||||TWO_SIDED|90.0|79.46|197.24||||||Buprenorphine||197.24|79.46|
74018401|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|220.97|||||TWO_SIDED|90.0|135.33|360.81||||||Buprenorphine||360.81|135.33|
74018402|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|249.28|||||TWO_SIDED|90.0|162.19|383.14||||||Buprenorphine||383.14|162.19|
74018403|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|94.44|||||TWO_SIDED|90.0|56.44|158.02||||||Buprenorphine||158.02|56.44|
74018404|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.57|||||TWO_SIDED|90.0|78.86|222.84||||||Buprenorphine||222.84|78.86|
74018405|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|233.99|||||TWO_SIDED|90.0|135.63|403.68||||||Buprenorphine||403.68|135.63|
74018406|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|263.97|||||TWO_SIDED|90.0|155.52|448.03||||||Buprenorphine||448.03|155.52|
74018407|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|159.38|||||TWO_SIDED|90.0|78.21|324.79||||||Norbuprenorphine||324.79|78.21|
74018408|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|106.93|||||TWO_SIDED|90.0|52.47|217.91||||||Norbuprenorphine||217.91|52.47|
74018409|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|87.1|||||TWO_SIDED|90.0|42.74|177.5||||||Norbuprenorphine||177.50|42.74|
74018410|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|182.98|||||TWO_SIDED|90.0|89.79|372.89||||||Norbuprenorphine||372.89|89.79|
74018411|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|122.77|||||TWO_SIDED|90.0|60.24|250.19||||||Norbuprenorphine||250.19|60.24|
74018412|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|69.12|||||TWO_SIDED|90.0|33.45|142.82||||||Naloxone||142.82|33.45|
74018413|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|282.17|||||TWO_SIDED|90.0|141.59|562.3||||||Naloxone||562.30|141.59|
74018414|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1497.7|||||TWO_SIDED|90.0|724.85|3094.59||||||Naloxone||3094.59|724.85|
74018415|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|87.64|||||TWO_SIDED|90.0|40.3|190.59||||||Naloxone||190.59|40.30|
74018416|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.86|||||TWO_SIDED|90.0|34.34|181.12||||||Naloxone||181.12|34.34|
74018417|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|321.94|||||TWO_SIDED|90.0|144.65|716.52||||||Naloxone||716.52|144.65|
73880839|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|0.81||||0.7407|TWO_SIDED|95.0|0.23|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.81|0.23|0.7407
73880840|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.55||||0.4929|TWO_SIDED|95.0|0.44|5.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.49|0.44|0.4929
73880841|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8496|TWO_SIDED|95.0|0.25|3.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.15|0.25|0.8496
73880842|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|1.92||||0.3248|TWO_SIDED|95.0|0.52|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.05|0.52|0.3248
73880843|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2589|TWO_SIDED|95.0|0.59|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.92|0.59|0.2589
74096864|NCT00325195|147742865|SUPERIORITY_OR_OTHER|||||||0.321||95.0|||||Fisher Exact|||% of pegloticase q4 participants reporting flares compared to placebo pts during Months 4-6 treatment period||||0.321
74096865|NCT00325195|147742866|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||t-test, 2 sided|||||||0.166
74096866|NCT00325195|147742866|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||||||0.170
74096867|NCT00325195|147742867|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
74096868|NCT00325195|147742867|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||||||0.024
74096869|NCT04228783|147742877|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
74096870|NCT04228783|147742877|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
73880844|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3318|TWO_SIDED|95.0|0.16|1.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.87|0.16|0.3318
73880845|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8536|TWO_SIDED|95.0|0.26|3.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.01|0.26|0.8536
73880846|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2817|TWO_SIDED|95.0|0.12|1.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.84|0.12|0.2817
73880847|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|0.59||||0.4091|TWO_SIDED|95.0|0.17|2.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.07|0.17|0.4091
74018418|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1708.83|||||TWO_SIDED|90.0|744.08|3924.47||||||Naloxone||3924.47|744.08|
74018419|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|84.2|||||TWO_SIDED|90.0|60.92|116.38||||||Naloxone-3-β-D-Glucuronide||116.38|60.92|
74018420|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|110.98|||||TWO_SIDED|90.0|82.02|150.17||||||Naloxone-3-β-D-Glucuronide||150.17|82.02|
74018421|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|81.97|||||TWO_SIDED|90.0|60.03|111.92||||||Naloxone-3-β-D-Glucuronide||111.92|60.03|
74018422|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|82.78|||||TWO_SIDED|90.0|59.89|114.42||||||Naloxone-3-β-D-Glucuronide||114.42|59.89|
74018423|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|101.71|||||TWO_SIDED|90.0|74.96|138.0||||||Naloxone-3-β-D-Glucuronide||138.00|74.96|
74018424|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|134.06|||||TWO_SIDED|90.0|101.07|177.82||||||Naloxone-3-β-D-Glucuronide||177.82|101.07|
74096871|NCT04228783|147742877|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.9|1.2||||||||1.2|0.9|
74096872|NCT04228783|147742878|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.2||||||||1.2|0.8|
74096873|NCT04228783|147742878|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||||1.3|0.8|
74096874|NCT04228783|147742878|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||||1.3|0.8|
74096875|NCT00626392|147742884|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Cochran-Mantel-Haenszel|||||||0.010
74096876|NCT00555152|147742907|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
74096877|NCT00392236|147742931|SUPERIORITY_OR_OTHER|||||||0.083|||||||ANOVA|||||||0.083
74096878|NCT03275064|147742986|SUPERIORITY||Mean Difference (Net)|0.48|||||TWO_SIDED|90.0|-30.73|31.69|||Mixed Models Analysis|||Week 16||31.69|-30.73|
74096879|NCT03275064|147742986|SUPERIORITY||Mean Difference (Net)|3.68|||||TWO_SIDED|90.0|-27.04|34.4|||Mixed Models Analysis|||Week 28||34.40|-27.04|
74047457|NCT05171816|147647502|OTHER|Exploratory|Hazard Ratio (HR)|1.14||||0.7251|TWO_SIDED|95.0|0.57|2.29||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.29|0.57|0.7251
74096880|NCT03275064|147742987|SUPERIORITY||Mean Difference (Final Values)|1.69|||||TWO_SIDED|90.0|-27.7|31.08|||Mixed Models Analysis|||Week 16||31.08|-27.70|
74096881|NCT03275064|147742987|SUPERIORITY||Mean Difference (Net)|5.97|||||TWO_SIDED|90.0|-23.03|34.97|||Mixed Models Analysis|||Week 28||34.97|-23.03|
74096882|NCT03275064|147742988|SUPERIORITY||Mean Difference (Net)|0.88|||||TWO_SIDED|90.0|-47.27|49.04|||Mixed Models Analysis|||Week 16||49.04|-47.27|
74096883|NCT03275064|147742988|SUPERIORITY||Mean Difference (Net)|2.27|||||TWO_SIDED|90.0|-43.11|47.65|||Mixed Models Analysis|||Week 28||47.65|-43.11|
74096884|NCT03275064|147742989|SUPERIORITY|Week 29|Mean Difference (Net)|200.18||||0.0131|TWO_SIDED|90.0|54.53|345.83|||Mixed Models Analysis|||||345.83|54.53|0.0131
74096885|NCT03275064|147742989|SUPERIORITY||Mean Difference (Net)|141.87||||0.0544|TWO_SIDED|90.0|-3.83|287.56|||Mixed Models Analysis|||Week 29||287.56|-3.83|0.0544
74096886|NCT03275064|147742989|SUPERIORITY||Mean Difference (Net)|228.27||||0.0067|TWO_SIDED|90.0|80.87|375.67|||Mixed Models Analysis|||Week 53||375.67|80.87|0.0067
74096887|NCT03275064|147742989|SUPERIORITY||Mean Difference (Net)|116.21||||0.0931|TWO_SIDED|90.0|-29.52|261.94|||Mixed Models Analysis|||Week 53||261.94|-29.52|0.0931
74096888|NCT03275064|147742990|SUPERIORITY||Mean Difference (Net)|0.05||||0.0574|TWO_SIDED|90.0|0.0|0.1|||Mixed Models Analysis|||Week 29||0.10|-0.00|0.0574
74096889|NCT03275064|147742990|SUPERIORITY||Mean Difference (Net)|0.06||||0.0248|TWO_SIDED|90.0|0.01|0.11|||Mixed Models Analysis|||Week 29||0.11|0.01|0.0248
74047458|NCT05171816|147647503|OTHER|Exploratory|Hazard Ratio (HR)|0.99||||0.9715|TWO_SIDED|95.0|0.6|1.64||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.64|0.60|0.9715
74047459|NCT05171816|147647504|OTHER|Exploratory|Hazard Ratio (HR)|0.68||||0.4937|TWO_SIDED|95.0|0.2|2.06||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.06|0.20|0.4937
74096890|NCT03275064|147742990|SUPERIORITY||Mean Difference (Net)|0.01||||0.3864|TWO_SIDED|90.0|-0.05|0.07|||Mixed Models Analysis|||Week 53||0.07|-0.05|0.3864
74096891|NCT03275064|147742990|SUPERIORITY||Mean Difference (Net)|0.02||||0.329|TWO_SIDED|90.0|-0.05|0.08|||Mixed Models Analysis|||Week 53||0.08|-0.05|0.3290
74096892|NCT03275064|147742991|SUPERIORITY||Mean Difference (Net)|4.75||||0.6184|TWO_SIDED|90.0|-21.36|30.85|||Mixed Models Analysis|||Week 16||30.85|-21.36|0.6184
74096893|NCT03275064|147742991|OTHER||Mean Difference (Net)|-7.32||||0.3194|TWO_SIDED|90.0|-33.16|18.53|||Mixed Models Analysis|||Week 28||18.53|-33.16|0.3194
74096894|NCT03275064|147742992|SUPERIORITY||Mean Difference (Net)|3.38|||||TWO_SIDED|90.0|-1.72|8.47|||Mixed Models Analysis|||Week 29||8.47|-1.72|
74096895|NCT03275064|147742992|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|90.0|-5.22|5.01|||Mixed Models Analysis|||Week 29||5.01|-5.22|
74096896|NCT03275064|147742992|SUPERIORITY||Mean Difference (Net)|-1.14|||||TWO_SIDED|90.0|-6.42|4.15|||Mixed Models Analysis|||Week 53||4.15|-6.42|
74096897|NCT03275064|147742992|SUPERIORITY||Mean Difference (Net)|-7.44|||||TWO_SIDED|90.0|-12.68|-2.2|||Mixed Models Analysis|||Week 53||-2.20|-12.68|
74096898|NCT03275064|147742993|SUPERIORITY||Mean Difference (Net)|2.09|||||TWO_SIDED|90.0|-3.49|7.66|||Mixed Models Analysis|||Week 29||7.66|-3.49|
74096899|NCT03275064|147742993|SUPERIORITY||Mean Difference (Net)|0.82|||||TWO_SIDED|90.0|-4.82|6.45|||Mixed Models Analysis|||Week 29||6.45|-4.82|
74096900|NCT03275064|147742993|SUPERIORITY||Mean Difference (Net)|2.29|||||TWO_SIDED|90.0|-3.54|8.11|||Mixed Models Analysis|||Week 53||8.11|-3.54|
74096901|NCT03275064|147742993|SUPERIORITY||Mean Difference (Net)|-5.96|||||TWO_SIDED|90.0|-11.81|-0.1|||Mixed Models Analysis|||Week 53||-0.10|-11.81|
74096902|NCT03275064|147742994|SUPERIORITY||Mean Difference (Net)|3.47|||||TWO_SIDED|90.0|-2.21|9.15|||Mixed Models Analysis|||Week 29||9.15|-2.21|
74096903|NCT03275064|147742994|SUPERIORITY||Mean Difference (Net)|-0.63|||||TWO_SIDED|90.0|-6.31|5.04|||Mixed Models Analysis|||Week 29||5.04|-6.31|
74096904|NCT03275064|147742994|SUPERIORITY||Mean Difference (Net)|-2.63|||||TWO_SIDED|90.0|-8.07|2.82|||Mixed Models Analysis|||Week 53||2.82|-8.07|
74096905|NCT03275064|147742994|SUPERIORITY||Mean Difference (Net)|-8.16|||||TWO_SIDED|90.0|-13.61|-2.72|||Mixed Models Analysis|||Week 53||-2.72|-13.61|
74096906|NCT00724048|147743019|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.078|TWO_SIDED|95.0|-2.47|0.13|||ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||0.13|-2.47|0.078
74096907|NCT00724048|147743019|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.084|TWO_SIDED|95.0|-2.53|0.16||Hypothesis testing was completed only if ACR16 45 mg BID (90 mg) vs. placebo was significant.|ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||0.16|-2.53|0.084
74096908|NCT00724048|147743019|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.982|TWO_SIDED|95.0|-1.35|1.32||Hypothesis testing was completed only if ACR16 22.5 mg BID (45 mg) vs. placebo was significant.|ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||1.32|-1.35|0.982
74096909|NCT00073021|147743036|SUPERIORITY_OR_OTHER||Difference in Success Rates|12.543||||0.0357|TWO_SIDED|95.0|0.96|24.12|||Chi-squared|||It was assumed that true rate of improvement for 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with 2-sided test, type I error of 0.05 (alpha = 0.05), and power of 80%, 120 patients with moderately active ulcerative colitis were required per group to complete the study.||24.12|0.96|0.0357
74096910|NCT00073021|147743037|SUPERIORITY_OR_OTHER||Difference Between Means|-0.5||||0.1594|TWO_SIDED|95.0|-1.28|0.21|||ANOVA|||||0.21|-1.28|0.1594
74096911|NCT00073021|147743037|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|The 2-sample t-test will be used to examine the treatment effect.||||||<0.0001
74096912|NCT00073021|147743037|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|Teh 2-sample t-test will be used to examine the treatment effect.||||||<0.0001
74096913|NCT00073021|147743038|SUPERIORITY_OR_OTHER||Difference in Success Rates|3.75||||0.5774|TWO_SIDED|95.0|-9.43|16.93|||Chi-squared|||||16.93|-9.43|0.5774
74096914|NCT00073021|147743039|SUPERIORITY_OR_OTHER||Difference in Success Rates|6.19||||0.2991|TWO_SIDED|95.0|-5.47|17.86|||Chi-squared|||||17.86|-5.47|0.2991
74096915|NCT00073021|147743040|SUPERIORITY_OR_OTHER||Difference in Success Rates|2.74||||0.6543|TWO_SIDED|95.0|-9.25|14.73|||Chi-squared|||||14.73|-9.25|0.6543
74096916|NCT00073021|147743041|SUPERIORITY_OR_OTHER||Difference in Success Rates|1.05||||0.8542|TWO_SIDED|95.0|-10.19|12.29|||Chi-squared|||||12.29|-10.19|0.8542
74096917|NCT00073021|147743042|SUPERIORITY_OR_OTHER||Difference in Success Rates|-0.96||||0.8859|TWO_SIDED|95.0|-14.09|12.17|||Chi-squared|||||12.17|-14.09|0.8859
74096918|NCT00073021|147743043|SUPERIORITY_OR_OTHER||Difference in Success Rates|9.73||||0.0758|TWO_SIDED|95.0|-0.94|20.4|||Chi-squared|||||20.40|-0.94|0.0758
74096919|NCT00073021|147743044|SUPERIORITY_OR_OTHER|||||||0.8308||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8308
74096920|NCT00073021|147743044|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
74096921|NCT00073021|147743044|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline.|t-test, 2 sided|||||||<0.0001
74096922|NCT00073021|147743045|SUPERIORITY_OR_OTHER|||||||0.534||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5340
74018425|NCT01846455|147588449|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.02|||||TWO_SIDED|90.0|73.93|132.61||||||Naloxone-3-β-D-Glucuronide||132.61|73.93|
74018426|NCT00847587|147588460|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 8 additional hours was chosen to be clinically relevant, as many common medical interventions (such as epidural anesthesia, cesarean delivery, labor induction, and general stress) have been reported to delay time to lactogenesis stage II by up to 12 hours.|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|120.0|<|0.05|TWO_SIDED|95.0|-10.6|7.7|||t-test, 2 sided|||It was assumed that both groups would have a mean of 54 hours to lactogenesis with a common standard deviation of 12 hours based on previous reports of lactogenesis in women with uncomplicated vaginal deliveries. Setting the noninferiority margin at 8 additional hours, using an alpha 0.05 level comparison, to achieve 80% power a sample size of n=34 evaluable subjects was required in each group. The calculation was performed using N Solution 2007 Professional Software.||7.7|-10.6|<0.05
74018427|NCT00847587|147588461|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.61|STANDARD_DEVIATION|1.8|<|0.05|TWO_SIDED|95.0|-1.3|2.5|||t-test, 2 sided|||||2.5|-1.3|<0.05
74018428|NCT00454779|147588462|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.051|TWO_SIDED|95.0|0.395|1.002|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone.|||1.002|0.395|0.051
74018429|NCT00454779|147588462|SUPERIORITY_OR_OTHER|||||||0.048|||||||Log Rank|Stratified by IVRS randomization factors||||||0.048
74018430|NCT00454779|147588463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.23|||||TWO_SIDED|95.0|-11.67|24.12|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS|||24.12|-11.67|
74018431|NCT00454779|147588463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||||95.0|0.57|3.33|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates|||3.33|0.57|
74018432|NCT00454779|147588464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.78|||||TWO_SIDED|95.0|-8.29|23.85|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS|||23.85|-8.29|
74018433|NCT00454779|147588464|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||||95.0|0.62|5.26|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates|||5.26|0.62|
74018434|NCT00454779|147588467|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.103||||0.663|TWO_SIDED|95.0|0.709|1.717|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone|||1.717|0.709|0.663
74018435|NCT00454779|147588467|SUPERIORITY_OR_OTHER|||||||0.666|||||||Log Rank|Stratified by IVRS randomization factors||||||0.666
74018436|NCT05425563|147588479|OTHER||Slope|8.3269|STANDARD_ERROR_OF_MEAN|0.8792|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
74018437|NCT05425563|147588480|OTHER||Slope|8.0809|STANDARD_ERROR_OF_MEAN|0.5414|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
74018438|NCT05425563|147588481|OTHER||Slope|8.121|STANDARD_ERROR_OF_MEAN|0.481|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
74018439|NCT05425563|147588488|OTHER||Slope|34.613|STANDARD_ERROR_OF_MEAN|0.602|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
74018440|NCT05425563|147588489|OTHER||Slope|33.9754|STANDARD_ERROR_OF_MEAN|0.426||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
74018441|NCT05425563|147588490|OTHER||Slope|31.63|STANDARD_ERROR_OF_MEAN|0.422|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
74018442|NCT00168831|147588501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
74018443|NCT00168831|147588501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
74018444|NCT00168831|147588502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.713|STANDARD_ERROR_OF_MEAN|1.052||0.0004||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||0.0004
74018445|NCT00168831|147588502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.445|STANDARD_ERROR_OF_MEAN|1.059||0.0012||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||0.0012
74018446|NCT00168831|147588503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_ERROR_OF_MEAN|0.165|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
74096923|NCT00073021|147743045|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
74096924|NCT00073021|147743045|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
74096925|NCT00073021|147743046|SUPERIORITY_OR_OTHER||Difference in Success Rates|11.1||||0.0966|TWO_SIDED|95.0|-1.87|24.14|||Chi-squared|||||24.14|-1.87|0.0966
74096926|NCT00073021|147743047|SUPERIORITY_OR_OTHER||Difference in Success Rates|9.75||||0.1173|TWO_SIDED|95.0|-2.39|21.89|||Chi-squared|||||21.89|-2.39|0.1173
74096927|NCT01672970|147743064|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical analysis at Month 3||||0.000
73880848|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|0.5||||0.3147|TWO_SIDED|95.0|0.13|1.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.93|0.13|0.3147
73880849|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8547|TWO_SIDED|95.0|0.24|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.24|0.24|0.8547
74047460|NCT05171816|147647505|OTHER|Exploratory|Hazard Ratio (HR)|1.65||||0.4923|TWO_SIDED|95.0|0.61|4.87||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||4.87|0.61|0.4923
74047461|NCT05171816|147647507|OTHER|Exploratory|Hazard Ratio (HR)|1.45||||0.3407|TWO_SIDED|95.0|0.63|3.39||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||3.39|0.63|0.3407
74047462|NCT02000622|147647522|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0009|TWO_SIDED|95.0|0.43|0.8||A priori threshold for statistical significance (2-sided) is 0.05.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Study is sized to provide 90% power to detect a true treatment effect of PFS hazard ratio 0.653.||0.80|0.43|0.0009
74047463|NCT02000622|147647523|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0033|TWO_SIDED|95.0|0.4|0.83||PFS2 tested using a multiple testing procedure with a recycling strategy. With 157 PFS2 events, a priori threshold for statistical significance (2-sided) was 0.008.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||0.83|0.40|0.0033
74047464|NCT02000622|147647524|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5665|TWO_SIDED|95.0|0.63|1.29||OS tested using a multiple testing procedure with a recycling strategy. With 140 OS events, a priori threshold for statistical significance (2-sided) was 0.018.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.29|0.63|0.5665
74047465|NCT02000622|147647526|SUPERIORITY||Mean Difference (Final Values)|7.5||||0.0035|TWO_SIDED|95.0|2.5|12.4|||Mixed Models Analysis|Variables for treatment, visit, treatment-visit interaction, adjusted for baseline global health status/QoL score, baseline score-visit interaction.|Mean difference \>0 favours olaparib.|||12.4|2.5|0.0035
74047466|NCT02000622|147647527|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0005|TWO_SIDED|95.0|0.41|0.78|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||0.78|0.41|0.0005
74047467|NCT02000622|147647528|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.24|0.47|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS.||0.47|0.24|<0.0001
74047468|NCT02000622|147647529|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.38|0.74|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS2.||0.74|0.38|0.0002
74047469|NCT02000622|147647530|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5131|TWO_SIDED|95.0|0.66|1.23||OS tested using a multiple testing procedure with a recycling strategy. With 192 OS events, a priori threshold for statistical significance was 0.045.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.23|0.66|0.5131
74047470|NCT02000622|147647531|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.4167|TWO_SIDED|95.0|0.67|1.18|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.18|0.67|0.4167
74047471|NCT02000622|147647532|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.27|0.5|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS.||0.50|0.27|<0.0001
74047472|NCT02000622|147647533|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.72|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS2.||0.72|0.40|<0.0001
74047473|NCT01405027|147647535|SUPERIORITY_OR_OTHER|||||||0.4864|TWO_SIDED||||||ANOVA|||||||0.4864
74047474|NCT05085327|147647540|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Original: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
74047475|NCT05085327|147647540|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Mint: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
74096928|NCT01672970|147743064|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
74096929|NCT01672970|147743065|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.001
74096930|NCT01672970|147743065|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.005
74096931|NCT01672970|147743066|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
74096932|NCT01672970|147743066|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
73880850|NCT03192176|147297626|SUPERIORITY||Odds Ratio (OR)|0.66||||0.5023|TWO_SIDED|95.0|0.2|2.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.19|0.20|0.5023
73880851|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0093|TWO_SIDED|95.0|1.41|11.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||11.35|1.41|0.0093
74047476|NCT05085327|147647540|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Black Cherry: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
74047477|NCT01320033|147647541|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.006|TWO_SIDED|95.0|-6.1|-1.1|||ANCOVA|||||-1.1|-6.1|0.006
73880852|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0035|TWO_SIDED|95.0|1.66|13.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||13.09|1.66|0.0035
73880853|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|8.48|||<|0.0001|TWO_SIDED|95.0|3.01|23.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.90|3.01|<0.0001
74047478|NCT01320033|147647541|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.024|TWO_SIDED|95.0|-5.4|-0.4|||ANCOVA|||||-0.4|-5.4|0.024
74047479|NCT01320033|147647541|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.595|TWO_SIDED|95.0|-3.2|1.8|||ANCOVA|||||1.8|-3.2|0.595
74047480|NCT05241470|147647559|SUPERIORITY||Mean Difference (Net)|0.01||||0.9575|TWO_SIDED||||||ANCOVA|||||||0.9575
74047481|NCT05241470|147647559|SUPERIORITY||Mean Difference (Net)|0.01||||0.9741|TWO_SIDED||||||ANCOVA|||||||0.9741
74047482|NCT05241470|147647560|SUPERIORITY|||||||0.5696|||||||ANCOVA|||||||0.5696
74047483|NCT05241470|147647561|SUPERIORITY|||||||0.0266|||||||Fisher Exact|||||||0.0266
74047484|NCT05241470|147647562|SUPERIORITY|||||||0.0055|||||||ANCOVA|||||||0.0055
74047485|NCT05241470|147647563|SUPERIORITY|||||||0.0097|||||||ANCOVA|||||||0.0097
74047486|NCT05241470|147647564|SUPERIORITY|||||||0.0137|||||||ANCOVA|||||||0.0137
74047487|NCT05241470|147647565|SUPERIORITY|||||||0.0332|||||||ANCOVA|||||||0.0332
74047488|NCT05241470|147647566|SUPERIORITY|||||||0.0394|||||||t-test, 2 sided|||||||0.0394
74047489|NCT05241470|147647567|SUPERIORITY|||||||0.0121|||||||Wilcoxon (Mann-Whitney)|||||||0.0121
74047490|NCT05241470|147647568|SUPERIORITY|||||||0.0224|||||||Wilcoxon (Mann-Whitney)|||||||0.0224
74047491|NCT03671148|147647618|SUPERIORITY||Response Rate Difference|24.5|||<|0.001|TWO_SIDED|95.0|15.9|33.0||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of current use of csDMARD (0 vs ≥ 1), number of prior biologic therapies (0 vs ≥ 1), and extent of psoriasis (≥ 3% BSA or \< 3% BSA) at Baseline.||33.0|15.9|<0.001
74047492|NCT03671148|147647619|SUPERIORITY||Least Squares (LS) Mean Difference|-0.16|||<|0.001|TWO_SIDED|95.0|-0.26|-0.07||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.07|-0.26|<0.001
74047493|NCT03671148|147647620|SUPERIORITY||Response Rate Difference|44.3|||<|0.001|TWO_SIDED|95.0|33.9|54.6||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||54.6|33.9|<0.001
74096933|NCT01672970|147743067|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
74096934|NCT01672970|147743067|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.001
74096935|NCT01672970|147743070|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
74096936|NCT01672970|147743070|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
74096937|NCT01672970|147743071|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
74096938|NCT01672970|147743071|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
74096939|NCT01672970|147743076|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
74096940|NCT01672970|147743076|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
74096941|NCT01672970|147743077|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
74096942|NCT01672970|147743077|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
74018447|NCT00168831|147588503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.075|STANDARD_ERROR_OF_MEAN|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
74096943|NCT01672970|147743078|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
74096944|NCT01672970|147743078|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
74096945|NCT01672970|147743079|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
74096946|NCT01672970|147743079|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
74096947|NCT01672970|147743080|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
74096948|NCT01672970|147743080|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
74096949|NCT01672970|147743081|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
74096950|NCT01672970|147743081|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
74018448|NCT00168831|147588504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.782||||0.0002|TWO_SIDED|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg vs. Placebo|||0.890|0.687|0.0002
74018449|NCT00168831|147588504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.725|||<|0.0001|TWO_SIDED|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg vs. Placebo|||0.828|0.635|<0.0001
74096951|NCT00390221|147743137|SUPERIORITY_OR_OTHER||Rate Ratio|0.461|||<|0.0001|TWO_SIDED|95.0|0.318|0.668||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (\<=2.5 vs \> 2.5), and age (\<=35 vs \>35)|Negative Binomial Regression|||||0.668|0.318|<0.0001
74096952|NCT00390221|147743137|SUPERIORITY_OR_OTHER||Rate Ratio|0.503||||0.0002|TWO_SIDED|95.0|0.352|0.721||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (\<=2.5 vs \> 2.5), and age (\<=35 vs \>35)|Negative Binomial Regression|||||0.721|0.352|0.0002
74096953|NCT00390221|147743138|SUPERIORITY_OR_OTHER||Percent Reduction|78.44|||<|0.0001|TWO_SIDED|95.0|65.97|86.35|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||86.35|65.97|<0.0001
74096954|NCT00390221|147743138|SUPERIORITY_OR_OTHER||Percent Reduction|69.47|||<|0.0001|TWO_SIDED|95.0|52.4|80.41|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||80.41|52.40|<0.0001
74096955|NCT00390221|147743139|SUPERIORITY_OR_OTHER||Percent Reduction|78.73|||<|0.0001|TWO_SIDED|95.0|71.33|84.22|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||84.22|71.33|<0.0001
74096956|NCT00390221|147743139|SUPERIORITY_OR_OTHER||Percent Reduction|70.23|||<|0.0001|TWO_SIDED|95.0|59.94|77.88|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||77.88|59.94|<0.0001
74096957|NCT00390221|147743140|SUPERIORITY_OR_OTHER||Hazard Ratio|0.49||||0.0003|TWO_SIDED|95.0|0.33|0.72||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (\<=2.5 versus \>2.5, p=0.449), and age (\<=35 versus \>35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.72|0.33|0.0003
74047494|NCT03671148|147647621|SUPERIORITY||Response Rate Difference|22.6|||<|0.001|TWO_SIDED|95.0|13.9|31.2||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||31.2|13.9|<0.001
74047495|NCT03671148|147647622|SUPERIORITY||Response Rate Difference|14.0|||<|0.001|TWO_SIDED|95.0|7.0|21.0||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||21.0|7.0|<0.001
74047496|NCT03671148|147647623|SUPERIORITY||LS Mean Difference|3.86|||<|0.001|TWO_SIDED|95.0|2.41|5.31||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||5.31|2.41|<0.001
74047497|NCT03671148|147647624|SUPERIORITY||LS Mean Difference|2.2||||0.009|TWO_SIDED|95.0|0.6|3.9||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||3.9|0.6|0.009
74047498|NCT03671148|147647625|SUPERIORITY||Response Rate Difference|16.6|||<|0.001|TWO_SIDED|95.0|9.7|23.6|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||23.6|9.7|<0.001
74047499|NCT03671148|147647626|SUPERIORITY||Response Rate Difference|6.0||||0.024|TWO_SIDED|95.0|0.8|11.3|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||11.3|0.8|0.024
74047500|NCT03671148|147647627|SUPERIORITY||Response Rate Difference|13.8||||0.009|TWO_SIDED|95.0|3.5|24.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||24.2|3.5|0.009
74047501|NCT03671148|147647628|SUPERIORITY||Response Rate Difference|38.8|||<|0.001|TWO_SIDED|95.0|22.9|54.8|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||54.8|22.9|<0.001
74047502|NCT02234050|147647635|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.204|TWO_SIDED|80.0|0.997|2.028|||Regression, Cox|||||2.028|0.997|0.204
74096958|NCT00390221|147743140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.3|0.67||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (\<=2.5 versus \>2.5, p=0.449), and age (\<=35 versus \>35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.67|0.30|<0.0001
74047503|NCT02234050|147647638|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.94|TWO_SIDED|95.0|0.53|1.71|||Regression, Cox|||||1.71|0.53|0.94
74047504|NCT00592176|147647640|SUPERIORITY_OR_OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
74047505|NCT02365506|147647642|SUPERIORITY||Difference in LSM|-7.7|STANDARD_ERROR_OF_MEAN|7.92||0.358|TWO_SIDED|95.0|-26.0|10.5|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|Least Square mean (LSM) and 95% confidence interval (CI) is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||10.5|-26.0|0.358
74047506|NCT02365506|147647642|SUPERIORITY||Difference in LSM|-1.7|STANDARD_ERROR_OF_MEAN|7.96||0.84|TWO_SIDED|95.0|-20.0|16.7|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||16.7|-20.0|0.840
74047507|NCT02365506|147647643|SUPERIORITY||Difference in LSM|-6.0|STANDARD_ERROR_OF_MEAN|5.83||0.338|TWO_SIDED|95.0|-19.8|7.8|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||7.8|-19.8|0.338
74047508|NCT02365506|147647643|SUPERIORITY||Difference in LSM|5.3|STANDARD_ERROR_OF_MEAN|6.21||0.425|TWO_SIDED|95.0|-9.4|19.9|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||19.9|-9.4|0.425
74047509|NCT02365506|147647644|SUPERIORITY||Difference in LSM|-6.5|STANDARD_ERROR_OF_MEAN|4.42||0.174|TWO_SIDED|95.0|-16.5|3.5|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||3.5|-16.5|0.174
74047510|NCT02365506|147647644|SUPERIORITY||Difference in LSM|3.4|STANDARD_ERROR_OF_MEAN|4.28||0.448|TWO_SIDED|95.0|-6.3|13.1|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||13.1|-6.3|0.448
74047511|NCT02365506|147647645|SUPERIORITY||Difference in LSM|8.8|STANDARD_ERROR_OF_MEAN|8.5||0.339|TWO_SIDED|95.0|-12.0|29.6|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||29.6|-12.0|0.339
74047512|NCT02365506|147647645|SUPERIORITY||Difference in LSM|12.8|STANDARD_ERROR_OF_MEAN|8.4||0.178|TWO_SIDED|95.0|-7.7|33.4|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||33.4|-7.7|0.178
74047513|NCT02365506|147647646|SUPERIORITY||Difference in LSM|4.9|STANDARD_ERROR_OF_MEAN|8.03||0.564|TWO_SIDED|95.0|-14.1|23.9|||Mixed Models Analysis|||||23.9|-14.1|0.564
74047514|NCT02365506|147647646|SUPERIORITY||Difference in LSM|2.7|STANDARD_ERROR_OF_MEAN|7.38||0.721|TWO_SIDED|95.0|-14.7|20.2|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||20.2|-14.7|0.721
74047515|NCT03728881|147647673|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.5|||||TWO_SIDED|96.0|0.44|0.57|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.57|0.44|
74047516|NCT03728881|147647675|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|Ratio of the GMCs|1.11|||||TWO_SIDED|96.0|0.95|1.29|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.29|0.95|
74047517|NCT03728881|147647677|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.42|||||TWO_SIDED|99.0|0.36|0.5|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.50|0.36|
74047518|NCT03728881|147647679|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.9|||||TWO_SIDED|99.0|0.75|1.08|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.08|0.75|
74047519|NCT03728881|147647680|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
74047520|NCT03728881|147647681|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.006|||||||Fisher Exact|||||||=0.006
74096959|NCT00390221|147743141|SUPERIORITY_OR_OTHER||Relative Mean Change|-1.93||||0.1284|TWO_SIDED|95.0|-4.42|0.56||Analysis of variance for difference between treatment groups, controlling for baseline score.|Analysis of Variance|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.56|-4.42|0.1284
74096960|NCT00390221|147743141|SUPERIORITY_OR_OTHER||Relative Mean Change|-4.27||||0.0008|TWO_SIDED|95.0|-6.76|-1.78|||Analysis of Variance|Analysis of variance for difference between treatment groups, controlling for baseline score.||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||-1.78|-6.76|0.0008
74047521|NCT03728881|147647682|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
74047522|NCT03728881|147647683|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.48|||||||Fisher Exact|||||||=0.48
74047523|NCT03728881|147647689|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.49|||||TWO_SIDED|96.0|0.42|0.56|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.56|0.42|
74047524|NCT03728881|147647690|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.||||||1|||||||Fisher Exact|||||||1.0
74047525|NCT03728881|147647692|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.09|||||TWO_SIDED|96.0|0.93|1.27||||||||1.27|0.93|
74047526|NCT03728881|147647693|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.0006|||||||Fisher Exact|||||||=0.0006
74047527|NCT03728881|147647695|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.41|||||TWO_SIDED|99.0|0.35|0.49|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.49|0.35|
74047528|NCT03728881|147647696|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
74047529|NCT03728881|147647698|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.86|||||TWO_SIDED|99.0|0.71|1.04|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.04|0.71|
74047530|NCT03728881|147647699|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.478|||||||Fisher Exact|||||||=0.478
74047531|NCT03728881|147647701|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.33|||||TWO_SIDED|95.0|1.12|1.58|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.58|1.12|
74047532|NCT03728881|147647704|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.29|||||TWO_SIDED|95.0|1.09|1.54|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.54|1.09|
74047533|NCT03728881|147647707|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.2|1.81|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.81|1.20|
74047534|NCT03728881|147647708|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose 9-10 year old girls and one-dose 11-14 year old girls. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
74047535|NCT03728881|147647710|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.15|1.75|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.75|1.15|
74047536|NCT03728881|147647711|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose 9-10 year old girls and one-dose 11-14 year old girls. A p-value under 0.05 will be regarded as significant.|||||=|0.368|||||||Fisher Exact|||||||=0.368
74096961|NCT02823652|147743191|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
74096962|NCT02823652|147743192|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
74096963|NCT02823652|147743193|SUPERIORITY|||||||0.312|||||||t-test, 2 sided|||||||0.312
74096964|NCT02823652|147743194|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
74096965|NCT00620659|147743213|SUPERIORITY_OR_OTHER|||||||0.615||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.615
74096966|NCT00620659|147743214|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-4.11|||||TWO_SIDED|90.0|-5.92|-2.3||||||||-2.30|-5.92|
74096967|NCT00620659|147743215|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-3.8|||||TWO_SIDED|90.0|-5.23|-2.38||||||||-2.38|-5.23|
74096968|NCT00620659|147743216|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.079
74096969|NCT00620659|147743217|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.003
73880854|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|7.57||||0.0002|TWO_SIDED|95.0|2.65|21.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||21.59|2.65|0.0002
74096970|NCT01193127|147743218|SUPERIORITY_OR_OTHER||least-squares mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.1||0||95.0|0.6|1.1||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates|repeated measures model|All data time points collected used in the analysis.|OMS302 - Vehicle (BSS)|||1.1|0.6|0.0000
74096971|NCT01193127|147743218|SUPERIORITY_OR_OTHER||least-squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.1||0||95.0|0.5|0.9||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates.|repeated measures model|OMS302 - ketorolac tromethamine||||0.9|0.5|0.0000
74096972|NCT01193127|147743219|SUPERIORITY_OR_OTHER||least-squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.2||0.0421||95.0|-8.9|-0.2||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates|repeated measures model||OMS302 - Vehicle (BSS)|||-0.2|-8.9|0.0421
74096973|NCT01193127|147743219|SUPERIORITY_OR_OTHER||least-squares mean difference|-5.9|STANDARD_ERROR_OF_MEAN|2.2||0.0093||95.0|-10.3|-1.5||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates.|repeated measures model||OMS302 - PE|||-1.5|-10.3|0.0093
74096974|NCT01193127|147743220|SUPERIORITY_OR_OTHER|||||||0.63||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.630
73880855|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1664|TWO_SIDED|95.0|0.73|6.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.22|0.73|0.1664
74096975|NCT01193127|147743220|SUPERIORITY_OR_OTHER|||||||0.769||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.769
74096976|NCT01193127|147743220|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.025
73880856|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0012|TWO_SIDED|95.0|1.94|14.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.96|1.94|0.0012
74096977|NCT01193127|147743221|SUPERIORITY_OR_OTHER|||||||0.229||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.229
74096978|NCT01193127|147743221|SUPERIORITY_OR_OTHER|||||||0.162||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.162
74096979|NCT01193127|147743221|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
74096980|NCT01193127|147743222|SUPERIORITY_OR_OTHER|||||||0.177||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.177
74096981|NCT01193127|147743222|SUPERIORITY_OR_OTHER|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.051
74096982|NCT01193127|147743222|SUPERIORITY_OR_OTHER|||||||0.497||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.497
74096983|NCT01193127|147743223|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.480
73880857|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|9.85|||<|0.0001|TWO_SIDED|95.0|3.49|27.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||27.86|3.49|<0.0001
73880858|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.73||||0.0334|TWO_SIDED|95.0|1.08|6.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.89|1.08|0.0334
74096984|NCT01193127|147743223|SUPERIORITY_OR_OTHER|||||||0.09||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.090
74096985|NCT01193127|147743223|SUPERIORITY_OR_OTHER|||||||0.439||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.439
74096986|NCT01193127|147743224|SUPERIORITY_OR_OTHER|||||||0.812||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.812
74096987|NCT01193127|147743224|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.480
74096988|NCT01193127|147743224|SUPERIORITY_OR_OTHER|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.160
73880859|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0034|TWO_SIDED|95.0|1.6|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.62|1.60|0.0034
73880860|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|6.55||||0.0002|TWO_SIDED|95.0|2.45|17.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.47|2.45|0.0002
73880861|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.9||||0.0014|TWO_SIDED|95.0|1.85|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.98|1.85|0.0014
73880862|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0872|TWO_SIDED|95.0|0.89|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.74|0.89|0.0872
74047537|NCT03728881|147647713|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.46|||||TWO_SIDED|96.0|0.38|0.56|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.56|0.38|
74047538|NCT03728881|147647713|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.58|||||TWO_SIDED|96.0|0.48|0.7|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.70|0.48|
74047539|NCT03728881|147647713|EQUIVALENCE|A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|||||=|0.079||||||The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|p-values test for heterogeneity|||||||=0.079
74047540|NCT03728881|147647714|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the older one-dose recipients and the older three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 36 months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).||||=1.0000
74047541|NCT03728881|147647716|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.01|||||TWO_SIDED|96.0|0.82|1.25||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.25|0.82|
74096989|NCT01193127|147743225|SUPERIORITY_OR_OTHER|||||||0.085||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.085
74096990|NCT01193127|147743225|SUPERIORITY_OR_OTHER|||||||0.742||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.742
74096991|NCT01193127|147743225|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.021
73880863|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0131|TWO_SIDED|95.0|1.28|7.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.98|1.28|0.0131
73880864|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0386|TWO_SIDED|95.0|1.05|6.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.43|1.05|0.0386
73880865|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0191|TWO_SIDED|95.0|1.2|8.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.05|1.20|0.0191
74096992|NCT01193127|147743226|SUPERIORITY_OR_OTHER|||||||0.081||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.081
73880866|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0291|TWO_SIDED|95.0|1.11|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.26|1.11|0.0291
73880867|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0004|TWO_SIDED|95.0|2.23|16.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.58|2.23|0.0004
74018450|NCT00168831|147588548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
74018451|NCT00168831|147588548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|||||ANCOVA||Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
74018452|NCT00168831|147588549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
74096993|NCT01193127|147743226|SUPERIORITY_OR_OTHER|||||||0.202||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.202
73880868|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|7.24||||0.0003|TWO_SIDED|95.0|2.49|21.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.02|2.49|0.0003
73880869|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.22||||0.0992|TWO_SIDED|95.0|0.86|5.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.72|0.86|0.0992
74018453|NCT00168831|147588549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
74018454|NCT00168831|147588550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
74018455|NCT00168831|147588550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.393|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
74018456|NCT00168831|147588551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.9|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
74018457|NCT00168831|147588551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.7|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
74018458|NCT00168831|147588552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
74018459|NCT00168831|147588552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.1|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
74018460|NCT00168831|147588553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0169||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||0.0169
74018461|NCT00168831|147588553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
74018462|NCT01087541|147588563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.5|<|0.01||95.0|0.0|1.0|||t-test, 2 sided|||||1|0|<0.01
74018463|NCT01087541|147588565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|5.0|<|0.001|TWO_SIDED|95.0|2.0|15.0|||t-test, 2 sided|||||15|2|<0.001
74018464|NCT00997516|147588590|SUPERIORITY_OR_OTHER|||||||0.01||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.01
74018465|NCT00997516|147588591|SUPERIORITY_OR_OTHER||||||<|0.01||||||Significant at p\<0.05|t-test, 2 sided|||||||<0.01
74018466|NCT00997516|147588600|SUPERIORITY_OR_OTHER|||||||0.86||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Overall body satisfaction||||0.86
74018467|NCT00997516|147588600|SUPERIORITY_OR_OTHER|||||||0.18||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Damage to body||||0.18
74018468|NCT00997516|147588600|SUPERIORITY_OR_OTHER|||||||0.04||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Physical attractiveness||||0.04
74018469|NCT00997516|147588600|SUPERIORITY_OR_OTHER|||||||0.34||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Masculinity/femininity||||0.34
74018470|NCT00997516|147588600|SUPERIORITY_OR_OTHER|||||||0.63||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Looking at oneself naked||||0.63
74018471|NCT00997516|147588601|SUPERIORITY_OR_OTHER|||||||0.48||||||Significant at p\<0.05|t-test, 2 sided|||Cosmetic appearance of abdomen||||0.48
74096994|NCT01193127|147743226|SUPERIORITY_OR_OTHER|||||||0.606||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.606
74096995|NCT01193127|147743227|SUPERIORITY_OR_OTHER|||||||0.893||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.893
74096996|NCT01193127|147743227|SUPERIORITY_OR_OTHER|||||||0.553||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.553
74096997|NCT01193127|147743227|SUPERIORITY_OR_OTHER|||||||0.412||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.412
74096998|NCT01193127|147743228|SUPERIORITY_OR_OTHER|||||||0.186||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.186
74096999|NCT01193127|147743228|SUPERIORITY_OR_OTHER|||||||0.191||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.191
74097000|NCT01193127|147743228|SUPERIORITY_OR_OTHER|||||||0.167||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.167
74097001|NCT01193127|147743229|SUPERIORITY_OR_OTHER|||||||0.663||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.663
74097002|NCT01193127|147743229|SUPERIORITY_OR_OTHER|||||||0.326||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.326
74097003|NCT01193127|147743229|SUPERIORITY_OR_OTHER|||||||0.045||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.045
74097004|NCT01193127|147743230|SUPERIORITY_OR_OTHER|||||||0.106||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.106
74097005|NCT01193127|147743230|SUPERIORITY_OR_OTHER|||||||0.519||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.519
74097006|NCT01193127|147743230|SUPERIORITY_OR_OTHER|||||||0.039||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.039
74097007|NCT01193127|147743231|SUPERIORITY_OR_OTHER|||||||0.1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.100
74097008|NCT01193127|147743231|SUPERIORITY_OR_OTHER|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.029
74097009|NCT01193127|147743231|SUPERIORITY_OR_OTHER|||||||0.525||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.525
74097010|NCT01193127|147743232|SUPERIORITY_OR_OTHER|||||||0.642||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.642
74097011|NCT01193127|147743232|SUPERIORITY_OR_OTHER|||||||0.442||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.442
74097012|NCT01193127|147743232|SUPERIORITY_OR_OTHER|||||||0.467||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.467
74097013|NCT01193127|147743233|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.695
74097014|NCT01193127|147743233|SUPERIORITY_OR_OTHER|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.355
74097015|NCT01193127|147743233|SUPERIORITY_OR_OTHER|||||||0.369||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.369
74097016|NCT01193127|147743234|SUPERIORITY_OR_OTHER|||||||0.124||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.124
74097017|NCT01193127|147743234|SUPERIORITY_OR_OTHER|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.298
74097018|NCT01193127|147743234|SUPERIORITY_OR_OTHER|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.291
73880870|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|5.66||||0.0006|TWO_SIDED|95.0|2.11|15.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.16|2.11|0.0006
74018472|NCT00997516|147588601|SUPERIORITY_OR_OTHER|||||||0.09||||||Significant at p\<0.05|t-test, 2 sided|||Cosmetic appearance of scars||||0.09
73880871|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.74||||0.006|TWO_SIDED|95.0|1.46|9.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.59|1.46|0.0060
73880872|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.01||||0.1472|TWO_SIDED|95.0|0.78|5.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.14|0.78|0.1472
74018473|NCT00997516|147588601|SUPERIORITY_OR_OTHER|||||||0.25||||||Significant at p\<0.05|t-test, 2 sided|||Satisfaction with scars||||0.25
74018474|NCT00997516|147588601|SUPERIORITY_OR_OTHER|||||||0.81||||||Significant at p\<0.05|t-test, 2 sided|||Discomfort of scars||||0.81
74018475|NCT00997516|147588601|SUPERIORITY_OR_OTHER||||||<|0.01||||||Significant at p\<0.05|t-test, 2 sided|||Overall impression of scars||||<0.01
74018476|NCT01970176|147588617|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
74018477|NCT01970176|147588618|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
74018478|NCT01970176|147588619|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
74018479|NCT01394705|147588620|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||.65
74018480|NCT01394705|147588620|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
74018481|NCT01394705|147588621|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
74018482|NCT04428411|147588632|OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
74018483|NCT04428411|147588633|OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.07
74018484|NCT04428411|147588634|OTHER|||||||0.41|||||||t-test, 2 sided|||||||0.41
74018485|NCT04428411|147588635|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
74018486|NCT04428411|147588636|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
74018487|NCT04428411|147588637|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
74018488|NCT04428411|147588638|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
74018489|NCT04428411|147588639|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74018490|NCT04428411|147588640|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74018491|NCT04428411|147588641|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
74018492|NCT04428411|147588641|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
74018493|NCT04428411|147588642|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
74018494|NCT04428411|147588642|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
74018495|NCT04428411|147588643|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
74018496|NCT04428411|147588643|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
74018497|NCT02918019|147588665|OTHER||Rate Ratio|0.57||||0.0049|TWO_SIDED|95.0|0.39|0.84|||Poisson regression|||||0.84|0.39|0.0049
74018498|NCT02918019|147588665|OTHER||Rate Ratio|0.78||||0.1838|TWO_SIDED|95.0|0.54|1.12|||Poisson regression|||||1.12|0.54|0.1838
74018499|NCT02918019|147588665|OTHER||Rate Ratio|0.63||||0.0144|TWO_SIDED|95.0|0.44|0.91|||Poisson regression|||||0.91|0.44|0.0144
74018500|NCT04823949|147588672|OTHER||Risk Ratio (RR)|1.59|||<|0.001|TWO_SIDED|95.0|1.33|1.88|||Chi-squared|||||1.88|1.33|<0.001
74018501|NCT04823949|147588673|OTHER||Risk Ratio (RR)|1.35||||0.53|TWO_SIDED|95.0|0.52|3.49|||Fisher Exact|||||3.49|0.52|.530
74018502|NCT04823949|147588674|OTHER||Risk Ratio (RR)|2.53||||0.059|TWO_SIDED|95.0|0.92|6.9|||Fisher Exact|||||6.90|0.92|.059
74018503|NCT04823949|147588675|OTHER||Risk Ratio (RR)|0.84||||0.792|TWO_SIDED|95.0|0.23|3.04|||Fisher Exact|||||3.04|0.23|.792
74018504|NCT04823949|147588676|OTHER||Risk Ratio (RR)|1.11||||0.21|TWO_SIDED|95.0|0.94|1.31|||Chi-squared|||||1.31|0.94|.210
74018505|NCT01700192|147588680|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||Wilcoxon (Mann-Whitney)|||||-0.40|-1.20|<0.001
74018506|NCT01700192|147588680|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-17.2|||||TWO_SIDED|95.0|-25.0|-9.7||||||||-9.7|-25.0|
74018507|NCT01700192|147588683|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.6|||<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||Wilcoxon (Mann-Whitney)|||||-0.30|-1.00|<0.001
74018508|NCT01700192|147588683|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-15.5|||||TWO_SIDED|95.0|-24.4|-7.3||||||||-7.3|-24.4|
74018509|NCT01700192|147588684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.154|TWO_SIDED|95.0|-0.35|0.05|||Zero-inflated Log-normal Model|||||0.05|-0.35|0.154
74018510|NCT01700192|147588684|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-18.4|||||TWO_SIDED|95.0|-41.0|4.3||||||||4.3|-41|
74018511|NCT01700192|147588685|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.7|-0.6|||Wilcoxon (Mann-Whitney)|||||-0.60|-1.70|<0.001
74018512|NCT01700192|147588685|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-16.7|||||TWO_SIDED|95.0|-24.6|-4.0||||||||-4.0|-24.6|
74097019|NCT01193127|147743235|SUPERIORITY_OR_OTHER|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.825
74097020|NCT01193127|147743235|SUPERIORITY_OR_OTHER|||||||0.211||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.211
74097021|NCT01193127|147743235|SUPERIORITY_OR_OTHER|||||||0.589||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.589
74097022|NCT01193127|147743236|SUPERIORITY_OR_OTHER|||||||0.401||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.401
74097023|NCT01193127|147743236|SUPERIORITY_OR_OTHER|||||||0.2||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Chi-squared, Corrected|||||||0.200
74097024|NCT01193127|147743236|SUPERIORITY_OR_OTHER|||||||0.478||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.478
74097025|NCT01193127|147743237|SUPERIORITY_OR_OTHER|||||||0.758||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.758
74097026|NCT01193127|147743237|SUPERIORITY_OR_OTHER|||||||0.521||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.521
74097027|NCT01193127|147743237|SUPERIORITY_OR_OTHER|||||||0.432||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.432
74097028|NCT01193127|147743238|SUPERIORITY_OR_OTHER|||||||0.148||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.148
74097029|NCT01193127|147743238|SUPERIORITY_OR_OTHER|||||||0.156||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.156
74018513|NCT01700192|147588686|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-9.1|-3.1|||Wilcoxon (Mann-Whitney)|||||-3.10|-9.10|<0.001
74097030|NCT01193127|147743238|SUPERIORITY_OR_OTHER|||||||0.381||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.381
74097031|NCT01193127|147743239|SUPERIORITY_OR_OTHER|||||||0.646||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.646
74097032|NCT01193127|147743239|SUPERIORITY_OR_OTHER|||||||0.95||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.950
74097033|NCT01193127|147743239|SUPERIORITY_OR_OTHER|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.160
74018514|NCT01700192|147588686|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-16.0|||||TWO_SIDED|95.0|-22.7|-8.3||||||||-8.3|-22.7|
74018515|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-79.456|STANDARD_ERROR_OF_MEAN|0.0819|<|0.0001|TWO_SIDED|80.0|-81.56|-77.11|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-77.11|-81.56|<0.0001
74097034|NCT01193127|147743240|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
74097035|NCT01193127|147743240|SUPERIORITY_OR_OTHER|||||||0.667||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.667
74097036|NCT01193127|147743240|SUPERIORITY_OR_OTHER|||||||0.303||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.303
74097037|NCT01193127|147743241|SUPERIORITY_OR_OTHER|||||||0.789||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.789
74097038|NCT01193127|147743241|SUPERIORITY_OR_OTHER|||||||0.977||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.977
74097039|NCT01193127|147743241|SUPERIORITY_OR_OTHER|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.336
74097040|NCT01193127|147743242|SUPERIORITY_OR_OTHER|||||||0.632||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.632
74018516|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-87.403|STANDARD_ERROR_OF_MEAN|0.0887|<|0.0001|TWO_SIDED|80.0|-88.8|-85.84|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-85.84|-88.80|<0.0001
74097041|NCT01193127|147743242|SUPERIORITY_OR_OTHER|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.778
74097042|NCT01193127|147743242|SUPERIORITY_OR_OTHER|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.336
74097043|NCT01193127|147743243|SUPERIORITY_OR_OTHER|||||||0.528||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.528
74097044|NCT01193127|147743243|SUPERIORITY_OR_OTHER|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.362
74097045|NCT01193127|147743243|SUPERIORITY_OR_OTHER|||||||0.353||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.353
74097046|NCT01193127|147743244|SUPERIORITY_OR_OTHER|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.463
74097047|NCT01193127|147743244|SUPERIORITY_OR_OTHER|||||||0.406||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.406
74097048|NCT01193127|147743244|SUPERIORITY_OR_OTHER|||||||0.245||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.245
74097049|NCT01193127|147743245|SUPERIORITY_OR_OTHER|||||||0.945||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.945
74097050|NCT01193127|147743245|SUPERIORITY_OR_OTHER|||||||0.438||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.438
74097051|NCT01193127|147743245|SUPERIORITY_OR_OTHER|||||||0.596||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.596
74097052|NCT01193127|147743246|SUPERIORITY_OR_OTHER|||||||0.811||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.811
74097053|NCT01193127|147743246|SUPERIORITY_OR_OTHER|||||||0.552||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.552
74097054|NCT01193127|147743246|SUPERIORITY_OR_OTHER|||||||0.549||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.549
74097055|NCT01193127|147743247|SUPERIORITY_OR_OTHER|||||||0.173||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.173
74097056|NCT01193127|147743247|SUPERIORITY_OR_OTHER|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.362
74097057|NCT01193127|147743247|SUPERIORITY_OR_OTHER|||||||0.559|||||||Cochran-Mantel-Haenszel|||||||0.559
74097058|NCT01193127|147743248|SUPERIORITY_OR_OTHER|||||||0.681||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.681
74097059|NCT01193127|147743248|SUPERIORITY_OR_OTHER|||||||0.429||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.429
74097060|NCT01193127|147743248|SUPERIORITY_OR_OTHER|||||||0.306||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.306
74097061|NCT01193127|147743249|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
74097062|NCT01193127|147743249|SUPERIORITY_OR_OTHER|||||||0.602||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.602
74097063|NCT01193127|147743249|SUPERIORITY_OR_OTHER|||||||0.29|||||||Cochran-Mantel-Haenszel|||||||0.290
74097064|NCT01193127|147743250|SUPERIORITY_OR_OTHER|||||||0.244||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.244
74097065|NCT01193127|147743250|SUPERIORITY_OR_OTHER|||||||0.122||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.122
74097066|NCT01193127|147743250|SUPERIORITY_OR_OTHER|||||||0.79||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.790
74097067|NCT01193127|147743251|SUPERIORITY_OR_OTHER|||||||0.752||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.752
74097068|NCT01193127|147743251|SUPERIORITY_OR_OTHER|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.355
74097069|NCT01193127|147743251|SUPERIORITY_OR_OTHER|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.292
74097070|NCT01193127|147743252|SUPERIORITY_OR_OTHER|||||||0.228||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.228
74097071|NCT01193127|147743252|SUPERIORITY_OR_OTHER|||||||0.564||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.564
74097072|NCT01193127|147743252|SUPERIORITY_OR_OTHER|||||||0.755||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.755
74097073|NCT01193127|147743253|SUPERIORITY_OR_OTHER|||||||0.018||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.018
74097074|NCT01193127|147743253|SUPERIORITY_OR_OTHER|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.292
74097075|NCT01193127|147743253|SUPERIORITY_OR_OTHER|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.298
74097076|NCT01193127|147743254|SUPERIORITY_OR_OTHER|||||||0.271||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.271
74097077|NCT01193127|147743254|SUPERIORITY_OR_OTHER|||||||0.345||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.345
74097078|NCT01193127|147743254|SUPERIORITY_OR_OTHER|||||||0.096||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.096
74097079|NCT01193127|147743255|SUPERIORITY_OR_OTHER|||||||0.32||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.320
74097080|NCT01193127|147743255|SUPERIORITY_OR_OTHER|||||||0.39||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.390
74097081|NCT01193127|147743255|SUPERIORITY_OR_OTHER|||||||0.23||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.230
74097082|NCT01193127|147743256|SUPERIORITY_OR_OTHER|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.778
74097083|NCT01193127|147743256|SUPERIORITY_OR_OTHER|||||||0.348||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.348
74097084|NCT01193127|147743256|SUPERIORITY_OR_OTHER|||||||0.477||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.477
74097085|NCT01193127|147743257|SUPERIORITY_OR_OTHER|||||||0.374||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.374
74097086|NCT01193127|147743257|SUPERIORITY_OR_OTHER|||||||0.265||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.265
74097087|NCT01193127|147743257|SUPERIORITY_OR_OTHER|||||||0.555||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.555
74018517|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-83.83|STANDARD_ERROR_OF_MEAN|0.0905|<|0.0001|TWO_SIDED|80.0|-85.65|-81.78|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-81.78|-85.65|<0.0001
74097088|NCT01193127|147743258|SUPERIORITY_OR_OTHER|||||||0.031||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.031
74097089|NCT01193127|147743258|SUPERIORITY_OR_OTHER|||||||0.059||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.059
74097090|NCT01193127|147743258|SUPERIORITY_OR_OTHER|||||||0.472||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.472
74097091|NCT01193127|147743259|SUPERIORITY_OR_OTHER|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.476
74097092|NCT01193127|147743259|SUPERIORITY_OR_OTHER|||||||0.169||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.169
74018518|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-92.138|STANDARD_ERROR_OF_MEAN|0.1041|<|0.0001|TWO_SIDED|80.0|-93.15|-90.98|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-90.98|-93.15|<0.0001
74097093|NCT01193127|147743259|SUPERIORITY_OR_OTHER|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.310
74097094|NCT01193127|147743260|SUPERIORITY_OR_OTHER|||||||0.075||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.075
74097095|NCT01193127|147743260|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.005
74097096|NCT01193127|147743260|SUPERIORITY_OR_OTHER|||||||0.078||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.078
74097097|NCT01193127|147743261|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
74097098|NCT01193127|147743261|SUPERIORITY_OR_OTHER|||||||0.357||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.357
74047542|NCT03728881|147647716|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.24|||||TWO_SIDED|96.0|1.01|1.54||||||The cohort for the analysis of HPV16 at 36 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11.||1.54|1.01|
74047543|NCT03728881|147647716|EQUIVALENCE|A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|||||=|0.14||||||The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|p-values test for heterogeneity|||||||=0.14
74047544|NCT03728881|147647717|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the younger one-dose recipients and the younger three-dose recipients.|||||=|0.001||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between younger one-dose recipients (9-11 Year Old Girls) and the younger three-dose recipients (18-21 Year Old Women).||||=0.001
74047545|NCT03728881|147647717|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between older one-dose and older three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.737||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between older one-dose recipients (12-14 Year Old Girls) and the older three-dose recipients (22-25 Year Old Women).||||=0.737
74047546|NCT03728881|147647719|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.41|||||TWO_SIDED|99.0|0.33|0.52||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.52|0.33|
74047547|NCT03728881|147647719|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.47|||||TWO_SIDED|99.0|0.37|0.6||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.60|0.37|
74047548|NCT03728881|147647719|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.028||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.028
74018519|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-84.814|STANDARD_ERROR_OF_MEAN|0.0971|<|0.0001|TWO_SIDED|80.0|-86.64|-82.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-82.74|-86.64|<0.0001
74018520|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-92.87|STANDARD_ERROR_OF_MEAN|0.1114|<|0.0001|TWO_SIDED|80.0|-93.85|-91.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-91.74|-93.85|<0.0001
74018521|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-79.465|STANDARD_ERROR_OF_MEAN|0.087|<|0.0001|TWO_SIDED|80.0|-81.69|-76.96|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-76.96|-81.69|<0.0001
74018522|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-88.711|STANDARD_ERROR_OF_MEAN|0.0963|<|0.0001|TWO_SIDED|80.0|-90.06|-87.18|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-87.18|-90.06|<0.0001
74018523|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-78.936|STANDARD_ERROR_OF_MEAN|0.0824|<|0.0001|TWO_SIDED|80.0|-81.11|-76.52|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-76.52|-81.11|<0.0001
74018524|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-86.28|STANDARD_ERROR_OF_MEAN|0.0899|<|0.0001|TWO_SIDED|80.0|-87.82|-84.55|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-84.55|-87.82|<0.0001
74018525|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-79.648|STANDARD_ERROR_OF_MEAN|0.0664|<|0.0001|TWO_SIDED|80.0|-81.36|-77.78|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-77.78|-81.36|<0.0001
74018526|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-84.985|STANDARD_ERROR_OF_MEAN|0.0715|<|0.0001|TWO_SIDED|80.0|-86.34|-83.5|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-83.50|-86.34|<0.0001
74018527|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|72.893|STANDARD_ERROR_OF_MEAN|0.0809|<|0.0001|TWO_SIDED|80.0|55.37|92.4|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||92.40|55.37|<0.0001
74018528|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|98.049|STANDARD_ERROR_OF_MEAN|0.0897|<|0.0001|TWO_SIDED|80.0|75.92|122.96|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||122.96|75.92|<0.0001
74097099|NCT01193127|147743261|SUPERIORITY_OR_OTHER|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.291
74097100|NCT01193127|147743262|SUPERIORITY_OR_OTHER|||||||0.172||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.172
74018529|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-80.164|STANDARD_ERROR_OF_MEAN|0.0668|<|0.0001|TWO_SIDED|80.0|-81.84|-78.33|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-78.33|-81.84|<0.0001
74018530|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-83.381|STANDARD_ERROR_OF_MEAN|0.0733|<|0.0001|TWO_SIDED|80.0|-84.92|-81.69|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-81.69|-84.92|<0.0001
74097101|NCT01193127|147743262|SUPERIORITY_OR_OTHER|||||||0.547||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.547
74097102|NCT01193127|147743262|SUPERIORITY_OR_OTHER|||||||0.921||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test|||||||0.921
74097103|NCT01193127|147743263|SUPERIORITY_OR_OTHER|||||||0.701||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.701
74097104|NCT01193127|147743263|SUPERIORITY_OR_OTHER|||||||0.089||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.089
74018531|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-78.408|STANDARD_ERROR_OF_MEAN|0.0602|<|0.0001|TWO_SIDED|80.0|-80.06|-76.62|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate||-76.62|-80.06|<0.0001
74018532|NCT02793232|147588735|SUPERIORITY||Percent change from baseline|-85.365|STANDARD_ERROR_OF_MEAN|0.0653|<|0.0001|TWO_SIDED|80.0|-86.57|-84.05|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-84.05|-86.57|<0.0001
74018533|NCT03979274|147588739|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|98.53|||||TWO_SIDED|90.0|94.55|102.68||||||||102.68|94.55|
74018534|NCT03979274|147588740|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|97.59|||||TWO_SIDED|90.0|91.34|104.26||||||||104.26|91.34|
74018535|NCT03979274|147588743|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|99.73|||||TWO_SIDED|90.0|98.45|101.03||||||||101.03|98.45|
74018536|NCT03979274|147588744|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|99.26|||||TWO_SIDED|90.0|97.7|100.85||||||||100.85|97.70|
74018537|NCT02105415|147588770|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.385|TWO_SIDED|95.0|-6.9|2.7|||ANCOVA|||5 minutes||2.7|-6.9|0.385
74018538|NCT02105415|147588770|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.241|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|||10 minutes||2.8|-10.8|0.241
74018539|NCT02105415|147588770|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.802|TWO_SIDED|95.0|-7.2|5.6|||ANCOVA|||15 minutes||5.6|-7.2|0.802
74018540|NCT02105415|147588771|SUPERIORITY|||||||0.605|||||||ANCOVA|||||||0.605
74018541|NCT02105415|147588772|SUPERIORITY|||||||0.212|||||||ANCOVA|||Pre-treatment||||0.212
74018542|NCT02105415|147588772|SUPERIORITY|||||||0.308|||||||ANCOVA|||New-onset pressors (within 3 minutes)||||0.308
74018543|NCT02105415|147588772|SUPERIORITY|||||||0.691|||||||ANCOVA|||Delayed-onset pressors (within 24 hrs)||||0.691
74018544|NCT02105415|147588774|SUPERIORITY|||||||0.911|||||||ANCOVA|||||||0.911
74018545|NCT02105415|147588775|SUPERIORITY|||||||0.069|||||||ANCOVA|||Red blood cell||||0.069
74018546|NCT02105415|147588775|SUPERIORITY|||||||0.046|||||||ANCOVA|||Non-red blood cell||||0.046
74018547|NCT02105415|147588775|SUPERIORITY|||||||0.502|||||||ANCOVA|||Colloid||||0.502
74018548|NCT02105415|147588776|SUPERIORITY|||||||0.994|||||||ANCOVA|||||||0.994
74018549|NCT02105415|147588777|SUPERIORITY|||||||0.233|||||||ANCOVA|||||||0.233
74018550|NCT01116544|147588784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005|TWO_SIDED|||||A priori threshold = 0.05|Wilcoxon (Mann-Whitney)|||||||<0.005
74018551|NCT01116544|147588785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis called for sample sizes of 32 participants in each treatment group. The study was close before reaching this number of participants.|||||<|0.001||||||Hypothesis: significant increase in score (post-tx - pre-tx) for both groups|ANCOVA|FMA scores adjusted for baseline differences.||||||<0.001
74018552|NCT01116544|147588786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||Across both groups, whether score increased following completion of intervention|ANCOVA|||||||0.001
74018553|NCT01116544|147588787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||Across both treatment groups|ANCOVA|||||||0.001
74018554|NCT01116544|147588788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Data combined between 2 treatment groups||||0.001
74018555|NCT01116544|147588789|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Both treatment groups combined||||>0.05
74018556|NCT01493180|147588811|SUPERIORITY_OR_OTHER|||||||0.576|||||||t-test, 2 sided|||||||0.576
74097105|NCT01193127|147743263|SUPERIORITY_OR_OTHER|||||||0.095||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.095
74097106|NCT01193127|147743264|SUPERIORITY_OR_OTHER|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.086
74097107|NCT01193127|147743264|SUPERIORITY_OR_OTHER|||||||0.092||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test|||||||0.092
74097108|NCT01193127|147743264|SUPERIORITY_OR_OTHER|||||||0.12||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.120
74097109|NCT01193127|147743265|SUPERIORITY_OR_OTHER|||||||0.626||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.626
73880873|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1284|TWO_SIDED|95.0|0.81|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.15|0.81|0.1284
74047549|NCT03728881|147647720|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the older one-dose recipients and the older three-dose recipients.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 24months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).||||=1.000
74047550|NCT03728881|147647722|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.85|||||TWO_SIDED|99.0|0.65|1.1||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.10|0.65|
74097110|NCT01193127|147743265|SUPERIORITY_OR_OTHER|||||||0.736||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.736
74097111|NCT01193127|147743265|SUPERIORITY_OR_OTHER|||||||0.725||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.725
74097112|NCT01193127|147743266|SUPERIORITY_OR_OTHER|||||||0.22||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.220
74097113|NCT01193127|147743266|SUPERIORITY_OR_OTHER|||||||0.903||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.903
74097114|NCT01193127|147743266|SUPERIORITY_OR_OTHER|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.463
74097115|NCT01193127|147743267|SUPERIORITY_OR_OTHER|||||||0.675||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.675
74097116|NCT01193127|147743267|SUPERIORITY_OR_OTHER|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|WIlcoxon rank-sum test|||||||0.825
74097117|NCT01193127|147743267|SUPERIORITY_OR_OTHER|||||||0.668||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.668
74097118|NCT01193127|147743268|SUPERIORITY_OR_OTHER|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2066
74097119|NCT01193127|147743268|SUPERIORITY_OR_OTHER|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2066
74097120|NCT01193127|147743268|SUPERIORITY_OR_OTHER|||||||0.5263||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.5263
74097121|NCT01193127|147743269|SUPERIORITY_OR_OTHER|||||||0.4222||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.4222
74097122|NCT01193127|147743269|SUPERIORITY_OR_OTHER|||||||0.2712||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2712
74097123|NCT01193127|147743269|SUPERIORITY_OR_OTHER|||||||0.8819||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.8819
74097124|NCT01193127|147743270|SUPERIORITY_OR_OTHER|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0510
74097125|NCT01193127|147743270|SUPERIORITY_OR_OTHER|||||||0.8084||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.8084
74097126|NCT01193127|147743270|SUPERIORITY_OR_OTHER|||||||0.1495||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.1495
73880874|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0117|TWO_SIDED|95.0|1.32|9.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.50|1.32|0.0117
74097127|NCT01193127|147743271|SUPERIORITY_OR_OTHER|||||||0.4099||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.4099
74097128|NCT01193127|147743271|SUPERIORITY_OR_OTHER|||||||0.6499||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.6499
74097129|NCT01193127|147743271|SUPERIORITY_OR_OTHER|||||||0.0765||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0765
74097130|NCT01193127|147743272|SUPERIORITY_OR_OTHER|||||||0.0688||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0688
74097131|NCT01193127|147743272|SUPERIORITY_OR_OTHER|||||||0.0314||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0314
74097132|NCT01193127|147743272|SUPERIORITY_OR_OTHER|||||||0.0775||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0775
74097133|NCT01193127|147743273|SUPERIORITY_OR_OTHER|||||||0.5369||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.5369
74097134|NCT01193127|147743273|SUPERIORITY_OR_OTHER|||||||0.3763||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.3763
74097135|NCT01193127|147743273|SUPERIORITY_OR_OTHER|||||||0.6144||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.6144
74097136|NCT01193127|147743274|SUPERIORITY_OR_OTHER|||||||0.1374||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.1374
74097137|NCT01193127|147743274|SUPERIORITY_OR_OTHER|||||||0.9146||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.9146
74097138|NCT01193127|147743274|SUPERIORITY_OR_OTHER|||||||0.7599||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.7599
74097139|NCT01193127|147743275|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
74097140|NCT01193127|147743275|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
74097141|NCT01193127|147743275|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
74097142|NCT01193127|147743276|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
74097143|NCT01193127|147743276|SUPERIORITY_OR_OTHER|||||||0.647||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.647
74097144|NCT01193127|147743276|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
73888092|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.1452|TWO_SIDED|95.0|-0.9|6.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.0|-0.9|0.1452
74018557|NCT00930059|147588939|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.73||0.3353|TWO_SIDED|90.0|-1.52|0.9||The primary test of significance was 1-sided, and a nominal Type I error rate a = 0.05 was employed.|ANCOVA|||Least squares (LS) mean difference and p-values were based on analysis of covariance (ANCOVA) on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.90|-1.52|0.3353
74018558|NCT00930059|147588940|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.72||0.6073|TWO_SIDED|90.0|-0.99|1.38||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 3: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||1.38|-0.99|0.6073
74018559|NCT00930059|147588940|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.73||0.3086|TWO_SIDED|90.0|-1.56|0.84||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 6: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.84|-1.56|0.3086
74097145|NCT01193127|147743277|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
74097146|NCT01193127|147743277|SUPERIORITY_OR_OTHER|||||||0.335||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.335
74097147|NCT01193127|147743277|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
74097148|NCT01193127|147743278|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
74097149|NCT01193127|147743278|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
74097150|NCT01193127|147743278|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
74097151|NCT01193127|147743279|SUPERIORITY_OR_OTHER|||||||0.824||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.824
74097152|NCT01193127|147743279|SUPERIORITY_OR_OTHER|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.476
74097153|NCT01193127|147743279|SUPERIORITY_OR_OTHER|||||||0.281||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.281
74097154|NCT01193127|147743280|SUPERIORITY_OR_OTHER|||||||0.842||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.842
74097155|NCT01193127|147743280|SUPERIORITY_OR_OTHER|||||||0.619||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.619
74097156|NCT01193127|147743280|SUPERIORITY_OR_OTHER|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.711
74097157|NCT01193127|147743281|SUPERIORITY_OR_OTHER|||||||0.773||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.773
74097158|NCT01193127|147743281|SUPERIORITY_OR_OTHER|||||||0.592||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.592
74097159|NCT01193127|147743281|SUPERIORITY_OR_OTHER|||||||0.787||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.787
74097160|NCT01193127|147743282|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.695
74097161|NCT01193127|147743282|SUPERIORITY_OR_OTHER|||||||0.166||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.166
74097162|NCT01193127|147743282|SUPERIORITY_OR_OTHER|||||||0.987||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.987
74097163|NCT01193127|147743283|SUPERIORITY_OR_OTHER|||||||0.134||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.134
74097164|NCT01193127|147743283|SUPERIORITY_OR_OTHER|||||||0.71||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.710
74097165|NCT01193127|147743283|SUPERIORITY_OR_OTHER|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.310
74097166|NCT01193127|147743284|SUPERIORITY_OR_OTHER|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.086
74097167|NCT01193127|147743284|SUPERIORITY_OR_OTHER|||||||0.183||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.183
74097168|NCT01193127|147743284|SUPERIORITY_OR_OTHER|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.029
74097169|NCT01193127|147743285|SUPERIORITY_OR_OTHER|||||||0.206||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.206
74097170|NCT01193127|147743285|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.021
74097171|NCT01193127|147743285|SUPERIORITY_OR_OTHER|||||||0.026||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.026
74097172|NCT01193127|147743286|SUPERIORITY_OR_OTHER|||||||0.822||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.822
74097173|NCT01193127|147743286|SUPERIORITY_OR_OTHER|||||||0.424||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.424
74097174|NCT01193127|147743286|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.695
74047551|NCT03728881|147647722|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|1.0|||||TWO_SIDED|99.0|0.77|1.29||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.29|0.77|
74047552|NCT03728881|147647722|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.24||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.24
74047553|NCT03728881|147647723|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between younger one-dose and younger three-dose recipients.|||||=|0.216||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between younger one-dose recipients (9-12 Year Old Girls) and younger three-dose recipients (18-21 Year Old Women).||||=0.216
74047554|NCT03728881|147647723|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between older one-dose and older three-dose recipients.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between older one-dose recipients (12-14 Year Old Girls) and older three-dose recipients (22-25 Year Old Women).||||=1.000
74047555|NCT03728881|147647725|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.52|||||TWO_SIDED|96.0|0.43|0.64||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.64|0.43|
74047556|NCT03728881|147647725|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.49|||||TWO_SIDED|96.0|0.41|0.58||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.58|0.41|
74047557|NCT03728881|147647725|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.73||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.73
74047558|NCT03728881|147647726|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate one-dose and three-dose recipients who enrolled June - August.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.||||=1.000
74097175|NCT01193127|147743287|SUPERIORITY_OR_OTHER|||||||0.489||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.489
74097176|NCT01193127|147743287|SUPERIORITY_OR_OTHER|||||||0.459||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.459
74097177|NCT01193127|147743287|SUPERIORITY_OR_OTHER|||||||0.99||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.990
74097178|NCT01193127|147743289|SUPERIORITY_OR_OTHER|||||||0.4575||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.4575
74097179|NCT01193127|147743289|SUPERIORITY_OR_OTHER|||||||0.8318||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.8318
74097180|NCT01193127|147743289|SUPERIORITY_OR_OTHER|||||||0.8946||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.8946
74097181|NCT01193127|147743290|SUPERIORITY_OR_OTHER|||||||0.157||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.1570
74047559|NCT03728881|147647728|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.26||||||96.0|1.0|1.58||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.58|1.00|
74047560|NCT03728881|147647728|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.01||||||96.0|0.83|1.24||||||||1.24|0.83|
74047561|NCT03728881|147647728|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.15||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.15
74047562|NCT03728881|147647729|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled April - May.|||||=|0.253||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled April - May.||||=0.253
74047563|NCT03728881|147647729|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|0.015||||||A p-value under 0.05 will be regarded as significant|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled June - August.||||=0.015
74047564|NCT03728881|147647731|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.43||||||99.0|0.33|0.55||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.55|0.33|
74047565|NCT03728881|147647731|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.42|||||TWO_SIDED|99.0|0.34|0.52||||||||0.52|0.34|
74047566|NCT03728881|147647731|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.95||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.95
74047567|NCT03728881|147647732|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.||||=1.000
74047568|NCT03728881|147647734|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.91|||||TWO_SIDED|99.0|0.69|1.19||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.19|0.69|
74047569|NCT03728881|147647734|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.89|||||TWO_SIDED|99.0|0.69|1.14||||||||1.14|0.69|
74047570|NCT03728881|147647734|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.88||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.88
74097182|NCT01193127|147743290|SUPERIORITY_OR_OTHER|||||||0.0839||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.0839
74097183|NCT01193127|147743290|SUPERIORITY_OR_OTHER|||||||0.092||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.0920
74047571|NCT03728881|147647735|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled April - May.|||||=|0.629||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled April - May.||||=0.629
74047572|NCT03728881|147647735|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|0.175||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled June - August.||||=0.175
74047573|NCT03728881|147647737|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.52||||||96.0|0.43|0.64||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.64|0.43|
74047574|NCT03728881|147647737|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.48||||||96.0|0.4|0.58||||||||0.58|0.40|
74047575|NCT03728881|147647737|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.46||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.46
74047576|NCT03728881|147647738|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
74097184|NCT01193127|147743291|SUPERIORITY_OR_OTHER|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.711
74047577|NCT03728881|147647740|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.27||||||96.0|1.03|1.57||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.57|1.03|
74047578|NCT03728881|147647740|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.99||||||96.0|0.8|1.23||||||||1.23|0.80|
74047579|NCT03728881|147647740|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.095||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.095
74047580|NCT03728881|147647741|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|0.327||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=0.327
74047581|NCT03728881|147647741|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from mountainous districts.|||||=|0.012||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.||||=0.012
74097185|NCT01193127|147743291|SUPERIORITY_OR_OTHER|||||||0.253||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.253
74097186|NCT01193127|147743291|SUPERIORITY_OR_OTHER|||||||0.104||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.104
74097187|NCT03246646|147743292|SUPERIORITY||Z test of proportions|0.66|||>|0.05|ONE_SIDED||||||Z test of independent proportions|||||||>.05
74097188|NCT02352779|147743293|OTHER||Mean Difference (Final Values)|0.6763|STANDARD_ERROR_OF_MEAN|0.4843||0.1666|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF||||0.1666
74047582|NCT03728881|147647743|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.45|||||TWO_SIDED|99.0|0.36|0.58||||||||0.58|0.36|
74047583|NCT03728881|147647743|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.4|||||TWO_SIDED|99.0|0.32|0.5||||||||0.50|0.32|
74047584|NCT03728881|147647743|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.3||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.30
74097189|NCT02352779|147743293|OTHER||Mean Difference (Final Values)|0.6936|STANDARD_ERROR_OF_MEAN|0.4567||0.1329|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF||||0.1329
74097190|NCT02352779|147743293|OTHER||Mean Difference (Final Values)|0.0831|STANDARD_ERROR_OF_MEAN|3.8065||0.9826|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF||||0.9826
74047585|NCT03728881|147647744|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
74047586|NCT03728881|147647746|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|1.02||||||99.0|0.79|1.32||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.32|0.79|
74047587|NCT03728881|147647746|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.81||||||99.0|0.63|1.04||||||||1.04|0.63|
74047588|NCT03728881|147647746|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.1||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.10
74047589|NCT03728881|147647747|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
74047590|NCT03728881|147647747|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from mountainous districts.|||||=|0.339||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.||||=0.339
74047591|NCT04088331|147647785|SUPERIORITY||||||<|0.001|||||||Exact binomial test|||"Hypotheses:~H0: p ≤ 0.65 H1: p \> 0.65 where p = the proportion of subjects who are a treatment success.~Hypotheses evaluated using a one-sided exact binomial test.~Power calculation assumed a treatment success rate of 80%. With a one-sided type I error of 0.025 and a type II error of 0.10 (90% power), a sample size of 96 subjects needed to demonstrate the proportion of subjects who are a treatment success exceeds 65%."||||< 0.001
74047592|NCT01994109|147647795|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74047593|NCT01994109|147647795|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74047594|NCT01994109|147647796|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74047595|NCT01994109|147647796|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74047596|NCT03233308|147647797|OTHER|||||||0.001|||||||t-test, 1 sided|||Mean Change from Baseline||||0.0010
74047597|NCT03233308|147647798|OTHER|||||||0.0003|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)||||0.0003
74047598|NCT03233308|147647799|OTHER|||||||0.0687|||||||t-test, 1 sided|||Mean change from baseline -EVP||||0.0687
74047599|NCT03233308|147647799|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline -IOP||||<0.0001
74097191|NCT02352779|147743293|OTHER||Mean Difference (Final Values)|2.9898|STANDARD_ERROR_OF_MEAN|3.5448||0.4016|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF||||0.4016
74097192|NCT03867097|147743327|SUPERIORITY||LS mean difference in change|-0.77|STANDARD_ERROR_OF_MEAN|4.047||0.8498|TWO_SIDED|95.0|-9.04|7.49|||ANCOVA||The Shapiro-Wilk normality test of residuals indicated that the data did not have a normal distribution (p-value 0.0108).|"Treatment comparison of change versus placebo. LS mean difference in change. When a subject had no RP attacks in the past 24 hours, the frequency was considered as zero for that day.~The LS means, SEs, CIs, and p-values came from an ANCOVA model with randomized treatment group and use of phosphodiesterase inhibitors at screening (yes, no) as factors and baseline as a covariate."||7.49|-9.04|0.8498
74097193|NCT03867097|147743327|SUPERIORITY||Median Difference (Final Values)|-0.24||||0.9729|TWO_SIDED|95.0|-9.97|9.32|||Wilcoxon (Mann-Whitney)|||"Change in the Weekly Frequency of Symptomatic Raynaud's Phenomenon Attacks From Baseline to the Double-Blind Endpoint Using Nonparametric Analysis - Modified Intent-to-Treat Population.~Treatment comparison of change versus placebo."||9.32|-9.97|0.9729
74018560|NCT00930059|147588940|SUPERIORITY||LS mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.73||0.197|TWO_SIDED|90.0|-1.82|0.58||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 9: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.58|-1.82|0.1970
74018561|NCT00930059|147588941|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6547|TWO_SIDED|90.0|-0.18|0.29||No adjustments made for multiple comparisons.|Linear model|||Week 3: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.29|-0.18|0.6547
74018562|NCT00930059|147588941|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.702|TWO_SIDED|90.0|-0.16|0.31||No adjustments made for multiple comparisons.|Linear model|||Week 6: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.31|-0.16|0.7020
74018563|NCT00930059|147588941|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.1138|TWO_SIDED|90.0|-0.41|0.06||No adjustments made for multiple comparisons.|Linear model|||Week 9: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.06|-0.41|0.1138
74018564|NCT00930059|147588941|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.0816|TWO_SIDED|90.0|-0.44|0.04||No adjustments made for multiple comparisons.|Linear model|||Week 12: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.04|-0.44|0.0816
74018565|NCT00930059|147588943|SUPERIORITY||LS mean difference|0.69|STANDARD_ERROR_OF_MEAN|0.96||0.7634|TWO_SIDED|90.0|-0.89|2.27||No adjustments have been made for multiple comparisons.|ANCOVA|||Change at Week 3: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.27|-0.89|0.7634
74018566|NCT00930059|147588943|SUPERIORITY||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|0.97||0.8077|TWO_SIDED|90.0|-0.75|2.45||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 6: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.45|-0.75|0.8077
74018567|NCT00930059|147588943|SUPERIORITY||LS mean difference|0.96|STANDARD_ERROR_OF_MEAN|0.98||0.835|TWO_SIDED|90.0|-0.66|2.57||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 9: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.57|-0.66|0.8350
74018568|NCT00930059|147588943|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.99||0.4377|TWO_SIDED|90.0|-1.78|1.48||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 12: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||1.48|-1.78|0.4377
74018569|NCT01641120|147589010|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||<.05
74018570|NCT01641120|147589011|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||0.193
74018571|NCT01641120|147589012|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||0.035
74018572|NCT01641120|147589013|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||.005
74018573|NCT03160560|147589021|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||<0.010
74018574|NCT03160560|147589021|SUPERIORITY|||||||0.932|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||.932
74018575|NCT03160560|147589021|SUPERIORITY|||||||0.853|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.853
74018576|NCT03160560|147589021|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||Baseline-2, Week 6, Week 7, Week 8||||.032
74018577|NCT03160560|147589021|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||<0.001
74018578|NCT03160560|147589021|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||.750
74018579|NCT03160560|147589021|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.810
74018580|NCT03160560|147589021|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.006
74047600|NCT03233308|147647800|OTHER|||||||0.0087|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline) -EVP||||0.0087
74047601|NCT03233308|147647800|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)- IOP||||<0.0001
74047602|NCT00976963|147647802|NON_INFERIORITY|The equivalence margin for non-inferiority of Fosfomycin to TMP/SMX is 10%.|||||<|0.001|||||||Wald test for noninferiority|||The null hypothesis is that Fosfomycin is inferior to TMP/SMX.||||<0.001
74097194|NCT01372774|147743328|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.35|0.63|||Log Rank|||||0.63|0.35|<0.0001
74097195|NCT01372774|147743329|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.7|TWO_SIDED|95.0|0.76|1.5|||Log Rank|||||1.50|0.76|0.70
74018581|NCT01815229|147589052|OTHER||||||<|0.05||||||P value applies to cell count at removal|t-test, 2 sided|||Tracheal lavages (TL) were done in intubated humans to obtain cell counts.||||<0.05
74018582|NCT00804687|147589054|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.126|STANDARD_ERROR_OF_MEAN|0.066||0.0602||95.0|-0.258|0.006|||Linear mixed model|||||0.006|-0.258|0.0602
74018583|NCT00804687|147589054|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.195|STANDARD_ERROR_OF_MEAN|0.067||0.0043||95.0|-0.328|-0.063|||Linear mixed model|||||-0.063|-0.328|0.0043
74097196|NCT01372774|147743330|SUPERIORITY|||||||0.00068||||||Intracranial Brain Control Rates estimated via 1-Cumulative Incidence Rate from Competing Risk survival analysis of time to the specific recurrence type. Deaths without recurrence are censored at time of death.|Gray's K-sample|||||||0.00068
73880875|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0067|TWO_SIDED|95.0|1.49|12.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||12.03|1.49|0.0067
74047603|NCT02148952|147647827|SUPERIORITY|We hypothesized a 15% reduction in the composite outcome between the intervention and control arm.|Risk Ratio (RR)|0.99||||0.9|TWO_SIDED|95.0|0.83|1.18|||Chi-squared, Corrected|In secondary analyses, a Rao-Scott test with 3 degrees of freedom resulted in a p value of 0.88.|Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.18|0.83|0.90
74047604|NCT02148952|147647828|SUPERIORITY||Risk Ratio (RR)|1.03||||0.67|TWO_SIDED|95.0|0.89|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.20|0.89|0.67
74047605|NCT02148952|147647829|SUPERIORITY||Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.89|1.2|||Chi-squared, Corrected|||||1.20|0.89|0.68
74047606|NCT02148952|147647830|SUPERIORITY||Risk Ratio (RR)|0.94||||0.56|TWO_SIDED|95.0|0.76|1.16|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.16|0.76|0.56
74047607|NCT02148952|147647831|SUPERIORITY||Risk Ratio (RR)|1.1||||0.19|TWO_SIDED|95.0|0.95|1.27|||Chi-squared, Corrected|||||1.27|0.95|0.19
74047608|NCT02148952|147647832|SUPERIORITY||Risk Ratio (RR)|1.11||||0.73|TWO_SIDED|95.0|0.74|1.53|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.53|0.74|0.73
74047609|NCT02148952|147647833|SUPERIORITY||Risk Ratio (RR)|0.97||||0.81|TWO_SIDED|95.0|0.79|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate any severe maternal complication within 7 days||1.20|0.79|0.81
74047610|NCT02148952|147647833|SUPERIORITY||Risk Ratio (RR)|0.89||||0.76|TWO_SIDED|95.0|0.57|1.52|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of seizures||1.52|0.57|0.76
74047611|NCT02148952|147647833|SUPERIORITY||Risk Ratio (RR)|0.98||||0.97|TWO_SIDED|95.0|0.7|1.41|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of loss of consciousness for \> 1 hr||1.41|0.70|0.97
74047612|NCT02148952|147647833|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9|TWO_SIDED|95.0|0.76|1.38|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of high fever with foul-smelling vaginal discharge||1.38|0.76|0.90
74047613|NCT02148952|147647833|SUPERIORITY||Risk Ratio (RR)|0.95||||0.61|TWO_SIDED|95.0|0.77|1.17|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of hemorrhage||1.17|0.77|0.61
74047614|NCT02148952|147647833|SUPERIORITY||Risk Ratio (RR)|0.5||||0.41|TWO_SIDED|95.0|0.34|1.58|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of stroke||1.58|0.34|0.41
74097197|NCT01372774|147743332|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
73888093|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.9303|TWO_SIDED|95.0|-3.6|3.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|-3.6|0.9303
74047615|NCT02148952|147647834|SUPERIORITY||Risk Ratio (RR)|1.07||||0.74|TWO_SIDED|95.0|0.72|1.58|||Chi-squared, Corrected|||||1.58|0.72|0.74
74047616|NCT02148952|147647835|SUPERIORITY||Risk Ratio (RR)|1.09||||0.57|TWO_SIDED|95.0|0.81|1.47|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.47|0.81|0.57
74047617|NCT02148952|147647836|SUPERIORITY||Risk Ratio (RR)|1.19||||0.41|TWO_SIDED|95.0|0.78|1.8|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.80|0.78|0.41
74047618|NCT02148952|147647837|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.45|2.13|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||2.13|0.45|0.95
74047619|NCT02148952|147647838|SUPERIORITY||Risk Ratio (RR)|0.99||||0.97|TWO_SIDED|95.0|0.69|1.43|||Chi-squared, Corrected|||||1.43|0.69|0.97
74047620|NCT02148952|147647839|SUPERIORITY||Risk Ratio (RR)|0.91||||0.32|TWO_SIDED|95.0|0.76|1.1|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.10|0.76|0.32
74047621|NCT02148952|147647840|SUPERIORITY||Risk Ratio (RR)|0.92||||0.3|TWO_SIDED|95.0|0.78|1.08|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.08|0.78|0.30
74047622|NCT02148952|147647841|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
74097198|NCT00792935|147743378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|4.4||0.847|TWO_SIDED|95.0|-7.9|9.6|||Constrained longitudinal analysis|||Using a standard deviation of 23.5 mg/dL, a sample size of at least 65 participants per treatment group would be required to have an 80% power to detect a true difference of 12.5 mg/dL between MK-0941 and glimepiride as measured by change from baseline in 24-hour WMG at Week 6.||9.6|-7.9|0.847
74047623|NCT02148952|147647842|SUPERIORITY||Other|0.0||||0.18|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Birth Companion Present||||0.18
74047624|NCT02148952|147647842|SUPERIORITY||Risk Ratio (RR)|9.8|||<|0.001|TWO_SIDED|95.0|3.4|28.3|||Chi-squared, Corrected|||Maternal blood pressure taken||28.3|3.4|<0.001
74047625|NCT02148952|147647842|SUPERIORITY||Risk Ratio (RR)|132.0|||<|0.001|TWO_SIDED|95.0|26.9|645.0|||Chi-squared, Corrected|||Maternal temperature taken||645|26.9|<0.001
74047626|NCT02148952|147647842|SUPERIORITY||Risk Ratio (RR)|7.3||||0.01|TWO_SIDED|95.0|1.5|35.6|||Chi-squared, Corrected|||Partography started||35.6|1.5|0.01
74047627|NCT02148952|147647842|SUPERIORITY||Risk Ratio (RR)|413.0|||<|0.001|TWO_SIDED|95.0|65.8|2589.0|||Chi-squared, Corrected|||Checklist use||2589|65.8|<0.001
74047628|NCT02148952|147647843|SUPERIORITY||Risk Ratio (RR)|53.3|||<|0.001|TWO_SIDED|95.0|13.1|217.0|||Chi-squared, Corrected|||Hand hygiene||217|13.1|<0.001
74047629|NCT02148952|147647843|SUPERIORITY||Risk Ratio (RR)|2.3||||0.007|TWO_SIDED|95.0|1.3|4.2|||Chi-squared, Corrected|||No oxytocin given before delivery||4.2|1.3|0.007
74047630|NCT02148952|147647843|SUPERIORITY||Risk Ratio (RR)|5.7|||<|0.001|TWO_SIDED|95.0|2.7|12.1|||Chi-squared, Corrected|||Clean towel available||12.1|2.7|<0.001
74047631|NCT02148952|147647843|SUPERIORITY||Risk Ratio (RR)|1.1||||0.72|TWO_SIDED|95.0|0.7|1.7|||Chi-squared, Corrected|||Clean scissors or blade available||1.7|0.7|0.72
74047632|NCT02148952|147647843|SUPERIORITY||Risk Ratio (RR)|1.0||||0.48|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available||1.0|1.0|0.48
74047633|NCT02148952|147647843|SUPERIORITY||Risk Ratio (RR)|1.0||||0.73|TWO_SIDED|95.0|0.9|1.1|||Chi-squared, Corrected|||Mucus extractor available||1.1|0.9|0.73
74047634|NCT02148952|147647843|SUPERIORITY||Risk Ratio (RR)|1.0||||0.56|TWO_SIDED|95.0|0.9|1.1|||Chi-squared, Corrected|||Neonatal bag and mask available||1.1|0.9|0.56
74047635|NCT02148952|147647843|SUPERIORITY||Risk Ratio (RR)|2.1||||0.005|TWO_SIDED|95.0|1.3|3.5|||Chi-squared, Corrected|||Pads available||3.5|1.3|0.005
74047636|NCT02148952|147647843|SUPERIORITY||Risk Ratio (RR)|185.0|||<|0.001|TWO_SIDED|95.0|19.7|1738.0|||Chi-squared, Corrected|||Checklist use||1738|19.7|<0.001
74047637|NCT02148952|147647844|SUPERIORITY||Risk Ratio (RR)|3.9|||<|0.001|TWO_SIDED|95.0|2.1|7.2|||Chi-squared, Corrected|||Oxytocin administered||7.2|2.1|<0.001
74047638|NCT02148952|147647844|SUPERIORITY||Risk Ratio (RR)|0.6||||0.25|TWO_SIDED|95.0|0.3|1.4|||Chi-squared, Corrected|||Neonatal bag used||1.4|0.3|0.25
74047639|NCT02148952|147647844|SUPERIORITY||Risk Ratio (RR)|1.0||||0.25|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth attendant present||1.0|1.0|0.25
74047640|NCT02148952|147647845|SUPERIORITY||Risk Ratio (RR)|1.1||||0.25|TWO_SIDED|95.0|0.9|1.4|||Chi-squared, Corrected|||Newborn weight taken||1.4|0.9|0.25
74047641|NCT02148952|147647845|SUPERIORITY||Risk Ratio (RR)|317.0|||<|0.001|TWO_SIDED|95.0|50.4|1989.0|||Chi-squared, Corrected|||Newborn temperature taken||1989|50.4|<0.001
74047642|NCT02148952|147647845|SUPERIORITY||Risk Ratio (RR)|7.3|||<|0.001|TWO_SIDED|95.0|2.4|22.0|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth||22.0|2.4|<0.001
74047643|NCT02148952|147647845|SUPERIORITY||Risk Ratio (RR)|38.7|||<|0.001|TWO_SIDED|95.0|7.7|194.0|||Chi-squared, Corrected|||Skin-to-skin care maintained for 1 hr||194|7.7|<0.001
74047644|NCT02148952|147647845|SUPERIORITY||Risk Ratio (RR)|19.4|||<|0.001|TWO_SIDED|95.0|11.4|33.2|||Chi-squared, Corrected|||Initiation of breast-feeding||33.2|11.4|<0.001
74047645|NCT02148952|147647845|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
74047646|NCT02148952|147647846|SUPERIORITY||Risk Ratio (RR)|182.0|||<|0.001|TWO_SIDED|95.0|33.5|993.0|||Chi-squared, Corrected|||Maternal temperature taken||993|33.5|<0.001
74047647|NCT02148952|147647846|SUPERIORITY||Risk Ratio (RR)|9.9|||<|0.001|TWO_SIDED|95.0|3.8|25.8|||Chi-squared, Corrected|||Maternal blood pressure taken||25.8|3.8|<0.001
74047648|NCT02148952|147647846|SUPERIORITY||Risk Ratio (RR)|0.4||||0.3|TWO_SIDED|95.0|0.1|2.1|||Chi-squared, Corrected|||Mother given magnesium sulfate||2.1|0.1|0.30
74047649|NCT02148952|147647847|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
74047650|NCT02148952|147647848|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present||1.0|1.0|1.00
74047651|NCT02148952|147647848|SUPERIORITY||Risk Ratio (RR)|19.1|||<|0.001|TWO_SIDED|95.0|7.9|46.5|||Chi-squared, Corrected|||Maternal blood pressure taken||46.5|7.9|<0.001
74047652|NCT02148952|147647848|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated due to 100% or 0% values in one group.|Maternal temperature taken||||<0.001
74047653|NCT02148952|147647848|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Partography started||||<0.001
74047654|NCT02148952|147647848|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
74047655|NCT02148952|147647849|SUPERIORITY||Risk Ratio (RR)|19.9|||<|0.001|TWO_SIDED|95.0|6.6|60.4|||Chi-squared, Corrected|||Hand hygiene||60.4|6.6|<0.001
74047656|NCT02148952|147647849|SUPERIORITY||Risk Ratio (RR)|2.1||||0.04|TWO_SIDED|95.0|1.0|4.1|||Chi-squared, Corrected|||No oxytocin given before delivery||4.1|1.0|0.04
74047657|NCT02148952|147647849|SUPERIORITY||Risk Ratio (RR)|2.4||||0.006|TWO_SIDED|95.0|1.3|4.3|||Chi-squared, Corrected|||Clean towel available||4.3|1.3|0.006
74047658|NCT02148952|147647849|SUPERIORITY||Risk Ratio (RR)|1.0||||0.34|TWO_SIDED|95.0|1.0|1.1|||Chi-squared, Corrected|||Clean scissors or blade available||1.1|1.0|0.34
74047659|NCT02148952|147647849|SUPERIORITY||Risk Ratio (RR)|1.0||||0.25|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available||1.0|1.0|0.25
74047660|NCT02148952|147647849|SUPERIORITY||Risk Ratio (RR)|1.0||||0.5|TWO_SIDED|95.0|1.0|1.1|||Chi-squared, Corrected|||Mucus extractor available||1.1|1.0|0.50
73880876|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4088|TWO_SIDED|95.0|0.59|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.71|0.59|0.4088
73880877|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0194|TWO_SIDED|95.0|1.2|7.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.96|1.20|0.0194
73880878|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0423|TWO_SIDED|95.0|1.03|6.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.73|1.03|0.0423
73880879|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2151|TWO_SIDED|95.0|0.7|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.99|0.70|0.2151
73880880|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0531|TWO_SIDED|95.0|0.99|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.42|0.99|0.0531
73880881|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0118|TWO_SIDED|95.0|1.37|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||12.34|1.37|0.0118
74047661|NCT02148952|147647849|SUPERIORITY||Risk Ratio (RR)|1.0||||0.32|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Neonatal bag and mask available||1.0|1.0|0.32
74047662|NCT02148952|147647849|SUPERIORITY||Risk Ratio (RR)|1.4||||0.11|TWO_SIDED|95.0|0.9|2.1|||Chi-squared, Corrected|||Pads available||2.1|0.9|0.11
74047663|NCT02148952|147647849|SUPERIORITY||Risk Ratio (RR)|37.9|||<|0.001|TWO_SIDED|95.0|7.3|196.0|||Chi-squared, Corrected|||Checklist available||196|7.3|<0.001
74047664|NCT02148952|147647850|SUPERIORITY||Risk Ratio (RR)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|7.5|||Chi-squared, Corrected|||Oxytocin administered||7.5|1.8|<0.001
73880882|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|16.28||||0.0006|TWO_SIDED|95.0|3.29|80.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||80.46|3.29|0.0006
74047665|NCT02148952|147647850|SUPERIORITY||Risk Ratio (RR)|0.6||||0.19|TWO_SIDED|95.0|0.3|1.3|||Chi-squared, Corrected|||Neonatal bag used||1.3|0.3|0.19
74047666|NCT02148952|147647850|SUPERIORITY||Risk Ratio (RR)|1.0||||0.5|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present||1.0|1.0|0.50
73880883|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3698|TWO_SIDED|95.0|0.59|4.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.22|0.59|0.3698
73880884|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0059|TWO_SIDED|95.0|1.55|13.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.53|1.55|0.0059
73880885|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0241|TWO_SIDED|95.0|1.17|9.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.44|1.17|0.0241
74047667|NCT02148952|147647851|SUPERIORITY||Risk Ratio (RR)|1.1||||0.08|TWO_SIDED|95.0|1.0|1.3|||Chi-squared, Corrected|||Newborn weight taken||1.3|1.0|0.08
74047668|NCT02148952|147647851|SUPERIORITY||Risk Ratio (RR)|91.5|||<|0.001|TWO_SIDED|95.0|11.0|758.0|||Chi-squared, Corrected|||Newborn temperature taken||758|11.0|<0.001
74047669|NCT02148952|147647851|SUPERIORITY||Risk Ratio (RR)|8.2|||<|0.001|TWO_SIDED|95.0|2.5|27.5|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth||27.5|2.5|<0.001
74047670|NCT02148952|147647851|SUPERIORITY||Other|0.0||||0.01|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Skin-to-skin care maintained for 1 hr||||0.01
74047671|NCT02148952|147647851|SUPERIORITY||Risk Ratio (RR)|7.9|||<|0.001|TWO_SIDED|95.0|3.7|16.7|||Chi-squared, Corrected|||Initiation of breast-feeding||16.7|3.7|<0.001
74047672|NCT02148952|147647851|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
74047673|NCT02148952|147647852|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Maternal temperature taken||||<0.001
74047674|NCT02148952|147647852|SUPERIORITY||Risk Ratio (RR)|12.7|||<|0.001|TWO_SIDED|95.0|4.7|34.3|||Chi-squared, Corrected|||Maternal blood pressure taken||34.3|4.7|<0.001
74047675|NCT02148952|147647852|SUPERIORITY||Risk Ratio (RR)|1.1||||0.95|TWO_SIDED|95.0|0.2|6.6|||Chi-squared, Corrected|||Mother given magnesium sulfate||6.6|0.2|0.95
74097199|NCT00792935|147743379|SUPERIORITY_OR_OTHER||Proportions|-7.7||||0.361|TWO_SIDED|95.0|-23.6|8.7|||Miettinen & Nurminen method.||The estimated value represents the difference in percentages, MK-0941 minus Glimepiride.|||8.7|-23.6|0.361
74097200|NCT04663295|147743394|SUPERIORITY||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|3.3|7.9||One-sided test at significant level of 0.025.|Wilcoxon (Mann-Whitney)|Wilcoxon Signed rank test comparing baseline and study period.||||7.9|3.3|<0.001
73880886|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5308|TWO_SIDED|95.0|0.5|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.77|0.50|0.5308
74047676|NCT02213081|147647905|EQUIVALENCE|Wilcoxon signed rank test was used to determine if the mean difference in pain scores before compared to during ulipristal therapy were equivalent or non-equivalent.|Mean Difference (Net)|3.5|STANDARD_ERROR_OF_MEAN|0.57|<|0.05|TWO_SIDED||||||Wilcoxon signed rank|||||||<0.05
74047677|NCT00423592|147647913|SUPERIORITY_OR_OTHER||Proportion|0.0|STANDARD_DEVIATION|0.0||0.01|TWO_SIDED|95.0|0.0|9.7|||Exact binomial test|A 1-sample test for a binomial proportion was performed.||Sample size: 30 participants; 80% power to rule out 50% recurrence rate of serum ALT/AST abnormalities following ambrisentan treatment (assumes 25% recurrence rate); 99% power to rule out 75% recurrence rate (assumes 37.5% recurrence rate). H\_0 = proportion of subjects experiencing primary endpoint at 12% vs 1-sided alternative of \< 12%. P-value from exact binomial test. Summary statistics included the estimated proportion, 95% confidence interval (CI), and the p-value of the hypothesis test.||9.7|0.0|0.01
74047678|NCT00423592|147647916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4|STANDARD_DEVIATION|49.6||0.009|TWO_SIDED|95.0|6.3|40.4|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) 6-minute walk distance change from baseline.||40.4|6.3|0.009
74047679|NCT00423592|147647917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|1.51||0.046|TWO_SIDED|95.0|-1.0|0.0|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) Borg dyspnea index change from baseline.||0.0|-1.0|0.046
74047680|NCT00423592|147647919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|STANDARD_DEVIATION|6.44||0.001|TWO_SIDED|95.0|2.1|7.1|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.1|2.1|0.001
74047681|NCT00423592|147647920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|8.98||0.059|TWO_SIDED|95.0|-0.1|6.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||6.8|-0.1|0.059
74047682|NCT00423592|147647921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|STANDARD_DEVIATION|6.86||0.002|TWO_SIDED|95.0|1.7|7.0|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.0|1.7|0.002
74047683|NCT00423592|147647922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|10.56||0.001|TWO_SIDED|95.0|3.1|11.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||11.3|3.1|0.001
74047684|NCT00423592|147647923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|6.4||0.017|TWO_SIDED|95.0|0.6|5.6|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||5.6|0.6|0.017
74047685|NCT00423592|147647924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|7.45||0.046|TWO_SIDED|95.0|0.1|5.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||5.8|0.1|0.046
74047686|NCT00423592|147647925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|7.23||0.003|TWO_SIDED|95.0|1.7|7.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.3|1.7|0.003
74047687|NCT00423592|147647926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|9.41||0.059|TWO_SIDED|95.0|-0.1|7.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.2|-0.1|0.059
74047688|NCT00423592|147647927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|13.96||0.152|TWO_SIDED|95.0|-1.5|9.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||9.3|-1.5|0.152
73880887|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.09||||0.8603|TWO_SIDED|95.0|0.41|2.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||2.90|0.41|0.8603
74047689|NCT00423592|147647928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|5.78||0.001|TWO_SIDED|95.0|1.7|6.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||6.2|1.7|0.001
74047690|NCT02485860|147647954|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
74047691|NCT03325010|147647960|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.5||0.1768|TWO_SIDED|95.0|-5.2|1.0||Nominal p-value is considered statistically significant if less than 0.05. To control for multiplicity, comparisons were tested sequentially.|Mixed Models Analysis|||||1.0|-5.2|0.1768
74097201|NCT03954834|147743411|SUPERIORITY||LS Mean Difference|-1.91|||<|0.001|TWO_SIDED|95.0|-2.18|-1.63|||Mixed Models Analysis|||||-1.63|-2.18|<0.001
74097202|NCT03954834|147743411|SUPERIORITY||LS Mean Difference|-1.93|||<|0.001|TWO_SIDED|95.0|-2.21|-1.65|||Mixed Models Analysis|||||-1.65|-2.21|<0.001
74097203|NCT03954834|147743411|SUPERIORITY||LS Mean Difference|-2.11|||<|0.001|TWO_SIDED|95.0|-2.39|-1.83|||Mixed Models Analysis|||||-1.83|-2.39|<0.001
74097204|NCT03954834|147743412|SUPERIORITY||LS Mean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-7.8|-4.7|||Mixed Models Analysis|||||-4.7|-7.8|<0.001
74097205|NCT03954834|147743412|SUPERIORITY||LS Mean Difference|-7.1|||<|0.001|TWO_SIDED|95.0|-8.6|-5.5|||Mixed Models Analysis|||||-5.5|-8.6|<0.001
74097206|NCT03954834|147743412|SUPERIORITY||LS Mean Difference|-8.8|||<|0.001|TWO_SIDED|95.0|-10.3|-7.2|||Mixed Models Analysis|||||-7.2|-10.3|<0.001
73880888|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0264|TWO_SIDED|95.0|1.17|11.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.95|1.17|0.0264
74047692|NCT03325010|147647961|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1095|TWO_SIDED|95.0|-0.6|0.1||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary outcome measure was statistically significant.|Mixed Models Analysis|||||0.1|-0.6|0.1095
74047693|NCT03325010|147647962|SUPERIORITY||Risk Difference (RD)|3.0||||0.819|TWO_SIDED|||||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary and preceding secondary outcome measures were statistically significant.|Cochran-Mantel-Haenszel|Stratified by baseline weight group (\<50 kg, ≥50 kg).||||||0.8190
74047694|NCT03325010|147647963|SUPERIORITY||Risk Difference (RD)|33.6||||0.0008|TWO_SIDED|||||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary and preceding secondary outcome measures were statistically significant.|Cochran-Mantel-Haenszel|Stratified by baseline weight group (\<50 kg, ≥50 kg)||||||0.0008
74047695|NCT02402881|147647964|OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our primary outcome was the proportion of non-administered doses of prescribed pharmacologic VTE prophylaxis. We compared rates of VTE prophylaxis non-administration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% confidence intervals (CIs), the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.||||<0.05
74047696|NCT02402881|147647965|OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our secondary outcome was the proportion of VTE events. We compared rates of VTE prophylaxis nonadministration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% CIs, the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.||||<0.05
74097207|NCT03954834|147743413|SUPERIORITY||Odds Ratio (OR)|49.0|||<|0.001|TWO_SIDED|95.0|21.12|113.67|||Regression, Logistic|||||113.67|21.12|<0.001
73880889|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0188|TWO_SIDED|95.0|1.29|16.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.42|1.29|0.0188
74018584|NCT00804687|147589054|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.066|STANDARD_ERROR_OF_MEAN|0.07||0.3513|TWO_SIDED|95.0|-0.206|0.075|||Linear mixed model|||||0.075|-0.206|0.3513
74018585|NCT00804687|147589055|SUPERIORITY_OR_OTHER||Least Squares Mean difference|8.604|STANDARD_ERROR_OF_MEAN|2.267||0.0003||95.0|4.104|13.104|||Linear mixed model|||||13.104|4.104|0.0003
74018586|NCT00804687|147589055|SUPERIORITY_OR_OTHER||Least Squares Mean difference|4.699|STANDARD_ERROR_OF_MEAN|2.289||0.0428||95.0|0.155|9.243|||Linear mixed model|||||9.243|0.155|0.0428
74018587|NCT00804687|147589055|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-3.905|STANDARD_ERROR_OF_MEAN|2.277||0.0895|TWO_SIDED|95.0|-8.424|0.614|||Linear mixed model|||||0.614|-8.424|0.0895
74018588|NCT03222427|147589085|OTHER||Ratio of Geometric Least Squares Means|0.952|||||TWO_SIDED|90.0|0.769|1.18||||||||1.18|0.769|
74018589|NCT01808612|147589131|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.264|TWO_SIDED|95.0|-0.55|2.0|||Mixed Models Analysis|||Approximately 522 participants were to be enrolled. Randomization was to be 2:1:3 (20 mg fluoxetine:40 mg fluoxetine:placebo). Assuming 5% of participants would have missing post-baseline data, the study had 85% power to detect an effect size of 0.33 (20 mg fluoxetine compared to placebo on HAMD21 total score) based on simulations with a 0.05 two-sided significance level.||2.00|-0.55|0.264
74018590|NCT03543410|147589201|SUPERIORITY||Mean Difference (Final Values)|-3.29|STANDARD_ERROR_OF_MEAN|1.625||0.044|TWO_SIDED|95.0|-6.489|-0.09||nominal p-value|Mixed Models Analysis|||||-0.090|-6.489|0.044
74018591|NCT03543410|147589201|SUPERIORITY||Mean Difference (Final Values)|-3.128|STANDARD_ERROR_OF_MEAN|1.597||0.051|TWO_SIDED|95.0|-6.273|0.017||nominal p-value|Mixed Models Analysis|||||0.017|-6.273|0.051
74018592|NCT03543410|147589202|SUPERIORITY||Mean Difference (Final Values)|-0.281|STANDARD_ERROR_OF_MEAN|0.191||0.143|TWO_SIDED|95.0|-0.658|0.095||nominal p-value|Mixed Models Analysis|||||0.095|-0.658|0.143
74018593|NCT03543410|147589202|SUPERIORITY||Mean Difference (Final Values)|-0.219|STANDARD_ERROR_OF_MEAN|0.187||0.243|TWO_SIDED|95.0|-0.588|0.15||nominal p-value|Mixed Models Analysis|||||0.150|-0.588|0.243
74018594|NCT02063035|147589207|SUPERIORITY|||||||0.1318|||||||Wilcoxon (Mann-Whitney)|||||||0.1318
74018595|NCT02642094|147589214|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.0020
74018596|NCT02642094|147589215|SUPERIORITY|||||||0.0137|||||||t-test, 2 sided|||||||0.0137
74018597|NCT02642094|147589216|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74018598|NCT02642094|147589217|SUPERIORITY|||||||0.0072|||||||t-test, 2 sided|||||||0.0072
74018599|NCT02642094|147589218|SUPERIORITY|||||||0.3093|||||||t-test, 2 sided|||||||0.3093
74018600|NCT00535925|147589223|OTHER||Cox Proportional Hazard|0.48|||<|0.05|TWO_SIDED||||||Regression, Cox|Cox Shared Frailty Model, adjusted for age, sex, SBP, Hb, eGFR, albuminuria, HbA1c, total cholesterol, triglycerides (log-scaled) to reduce bias risk.||||||<0.05
74047697|NCT00460525|147647986|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.17||||0.175||95.0|-0.09|0.37||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|No adjustments were made.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first clinical malaria episode with significant parasitemia (2500/mm\^3) and temperature of greater than or equal to 37.5 degrees C was analyzed by fitting a Cox Proportional Hazards model. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||0.37|-0.09|0.175
74047698|NCT00460525|147647988|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.2||||0.068||95.0|-0.02|0.37||The a priori threshold for statistical significance was set at 0.05.|Poisson regression|No adjustments|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Poisson model fit.|Incidence density, defined as number of clinical malaria episodes per PYAR, was compared using Poisson regression. The null hypothesis of no vaccine efficacy was tested. The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||0.37|-0.02|0.068
74047699|NCT03073200|147647998|SUPERIORITY||Mean Difference (Final Values)|63.7|||<|0.001|TWO_SIDED|95.0|51.0|76.4|||Fisher Exact|||||76.4|51.0|<0.001
74047700|NCT03073200|147647999|SUPERIORITY||Mean Difference (Final Values)|70.2|||<|0.001|TWO_SIDED|95.0|59.3|81.0|||Fisher Exact|||||81|59.3|<0.001
74047701|NCT03073200|147648000|SUPERIORITY||Mean Difference (Final Values)|72.9|||<|0.001|TWO_SIDED|95.0|63.3|82.5|||Fisher Exact|||||82.5|63.3|<0.001
74047702|NCT03073200|147648001|SUPERIORITY||Mean Difference (Final Values)|50.4|||<|0.001|TWO_SIDED|95.0|40.6|60.2|||Fisher Exact|||||60.2|40.6|<0.001
74047703|NCT03073200|147648002|SUPERIORITY||Mean Difference (Final Values)|47.8|||<|0.001|TWO_SIDED|95.0|38.0|57.6|||Fisher Exact|||||57.6|38.0|<0.001
74047704|NCT03073200|147648003|SUPERIORITY||Mean Difference (Final Values)|45.0|||<|0.001|TWO_SIDED|95.0|33.2|56.8|||Fisher Exact|||||56.8|33.2|<0.001
74047705|NCT03073200|147648004|SUPERIORITY||Mean Difference (Final Values)|40.7|||<|0.001|TWO_SIDED|95.0|29.3|52.0|||Fisher Exact|||||52.0|29.3|<0.001
74097208|NCT03954834|147743413|SUPERIORITY||Odds Ratio (OR)|80.39|||<|0.001|TWO_SIDED|95.0|31.8|203.19|||Regression, Logistic|||||203.19|31.80|<0.001
74097209|NCT03954834|147743413|SUPERIORITY||Odds Ratio (OR)|52.95|||<|0.001|TWO_SIDED|95.0|22.3|125.73|||Regression, Logistic|||||125.73|22.30|<0.001
74097210|NCT03954834|147743414|SUPERIORITY||LS Mean Difference|-1.5||||0.776|TWO_SIDED|95.0|-11.9|8.9|||Mixed Models Analysis|||||8.9|-11.9|0.776
73880890|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7642|TWO_SIDED|95.0|0.42|3.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.27|0.42|0.7642
74047706|NCT03073200|147648005|SUPERIORITY||Mean Difference (Final Values)|51.1|||<|0.001|TWO_SIDED|95.0|35.3|66.9|||Fisher Exact|||||66.9|35.3|<0.001
74047707|NCT03073200|147648006|SUPERIORITY||Mean Difference (Final Values)|41.1|||<|0.001|TWO_SIDED|95.0|27.0|55.2|||Fisher Exact|||||55.2|27.0|<0.001
74047708|NCT03073200|147648007|SUPERIORITY||Mean Difference (Final Values)|-17.04|STANDARD_ERROR_OF_MEAN|5.747||0.005|TWO_SIDED|95.0|-28.7|-5.38|||Mixed Models Analysis|||||-5.38|-28.70|0.005
74047709|NCT03073200|147648008|SUPERIORITY||Mean Difference (Final Values)|-15.36|STANDARD_ERROR_OF_MEAN|1.682|<|0.001|TWO_SIDED|95.0|-18.69|-12.04|||Mixed Models Analysis|||||-12.04|-18.69|<0.001
74047710|NCT03073200|147648009|SUPERIORITY||Mean Difference (Final Values)|-12.01|STANDARD_DEVIATION|3.853||0.006|TWO_SIDED|95.0|-20.11|-3.9|||Mixed Models Analysis|||||-3.90|-20.11|0.006
74047711|NCT03073200|147648012|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.089|TWO_SIDED|95.0|0.1|41.7|||Fisher Exact|||||41.7|0.1|0.089
74047712|NCT03073200|147648013|SUPERIORITY||Mean Difference (Final Values)|23.0||||0.07|TWO_SIDED|95.0|0.6|45.4|||Fisher Exact|||||45.4|0.6|0.070
74047713|NCT02859558|147648089|SUPERIORITY|||||||0.48||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||0.48
74047714|NCT02859558|147648089|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
74097211|NCT03954834|147743414|SUPERIORITY||LS Mean Difference|-2.6||||0.622|TWO_SIDED|95.0|-13.0|7.8|||Mixed Models Analysis|||||7.8|-13.0|0.622
74097212|NCT03954834|147743414|SUPERIORITY||LS Mean Difference|-0.6||||0.908|TWO_SIDED|95.0|-11.1|9.8|||Mixed Models Analysis|||||9.8|-11.1|0.908
74097213|NCT03954834|147743415|SUPERIORITY||Odds Ratio (OR)|40.28|||<|0.001|TWO_SIDED|95.0|7.74|209.71|||Regression, Logistic|||||209.71|7.74|<0.001
74097214|NCT03954834|147743415|SUPERIORITY||Odds Ratio (OR)|34.12|||<|0.001|TWO_SIDED|95.0|6.53|178.19|||Regression, Logistic|||||178.19|6.53|<0.001
74097215|NCT03954834|147743415|SUPERIORITY||Odds Ratio (OR)|85.13|||<|0.001|TWO_SIDED|95.0|16.36|443.13|||Regression, Logistic|||||443.13|16.36|<0.001
74097216|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.1|-31.2|||Mixed Models Analysis|||Morning Premeal - Fasting||-31.2|-44.1|<0.001
74097217|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-38.6|||<|0.001|TWO_SIDED|95.0|-45.1|-32.2|||Mixed Models Analysis|||Morning Premeal - Fasting||-32.2|-45.1|<0.001
74097218|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-36.5|||<|0.001|TWO_SIDED|95.0|-43.1|-29.8|||Mixed Models Analysis|||Morning Premeal - Fasting||-29.8|-43.1|<0.001
74097219|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-57.9|||<|0.001|TWO_SIDED|95.0|-68.4|-47.4|||Mixed Models Analysis|||Morning 2-hour Postmeal||-47.4|-68.4|<0.001
74047715|NCT02859558|147648089|SUPERIORITY|||||||0.5||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.50
74047716|NCT02859558|147648089|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
74047717|NCT02859558|147648089|SUPERIORITY|||||||0.44||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.44
74047718|NCT02859558|147648089|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
74047719|NCT02859558|147648090|SUPERIORITY|||||||0.39||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.39
74047720|NCT02859558|147648090|SUPERIORITY|||||||0.46||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.46
74047721|NCT02859558|147648090|SUPERIORITY|||||||0.056||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.056
74047722|NCT02859558|147648090|SUPERIORITY|||||||0.025||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.025
74047723|NCT02859558|147648090|SUPERIORITY|||||||0.072||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.072
74047724|NCT02859558|147648090|SUPERIORITY|||||||0.47||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.47
74047725|NCT02859558|147648090|SUPERIORITY|||||||0.086||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.086
74097220|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-49.7|||<|0.001|TWO_SIDED|95.0|-60.3|-39.2|||Mixed Models Analysis|||Morning 2-hour Postmeal||-39.2|-60.3|<0.001
74047726|NCT02859558|147648090|SUPERIORITY|||||||0.18||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.18
74047727|NCT02859558|147648090|SUPERIORITY|||||||0.88||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.88
74047728|NCT02859558|147648090|SUPERIORITY|||||||0.061||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.061
74047729|NCT02859558|147648090|SUPERIORITY|||||||0.042||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.042
74047730|NCT02859558|147648090|SUPERIORITY|||||||0.54||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.54
74097221|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-57.3|||<|0.001|TWO_SIDED|95.0|-68.1|-46.4|||Mixed Models Analysis|||Morning 2-hour Postmeal||-46.4|-68.1|<0.001
74097222|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-40.9|||<|0.001|TWO_SIDED|95.0|-49.6|-32.2|||Mixed Models Analysis|||Midday Premeal||-32.2|-49.6|<0.001
74097223|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-39.9|||<|0.001|TWO_SIDED|95.0|-48.6|-31.2|||Mixed Models Analysis|||Midday Premeal||-31.2|-48.6|<0.001
74097224|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-40.0|||<|0.001|TWO_SIDED|95.0|-49.0|-31.1|||Mixed Models Analysis|||Midday Premeal||-31.1|-49.0|<0.001
74097225|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-51.4|||<|0.001|TWO_SIDED|95.0|-62.5|-40.4|||Mixed Models Analysis|||Midday 2-hour Postmeal||-40.4|-62.5|<0.001
74097226|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-47.3|||<|0.001|TWO_SIDED|95.0|-58.4|-36.2|||Mixed Models Analysis|||Midday 2-hour Postmeal||-36.2|-58.4|<0.001
74097227|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-50.7|||<|0.001|TWO_SIDED|95.0|-62.1|-39.3|||Mixed Models Analysis|||Midday 2-hour Postmeal||-39.3|-62.1|<0.001
74097228|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-39.0|||<|0.001|TWO_SIDED|95.0|-47.6|-30.4|||Mixed Models Analysis|||Evening Premeal||-30.4|-47.6|<0.001
74097229|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-39.2|||<|0.001|TWO_SIDED|95.0|-47.9|-30.6|||Mixed Models Analysis|||Evening Premeal||-30.6|-47.9|<0.001
74097230|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-36.4|||<|0.001|TWO_SIDED|95.0|-45.3|-27.5|||Mixed Models Analysis|||Evening Premeal||-27.5|-45.3|<0.001
74097231|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-51.7|||<|0.001|TWO_SIDED|95.0|-63.2|-40.1|||Mixed Models Analysis|||Evening 2-hour Postmeal||-40.1|-63.2|<0.001
74097232|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-52.5|||<|0.001|TWO_SIDED|95.0|-64.1|-40.9|||Mixed Models Analysis|||Evening 2-hour Postmeal||-40.9|-64.1|<0.001
74097233|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-53.2|||<|0.001|TWO_SIDED|95.0|-65.1|-41.3|||Mixed Models Analysis|||Evening 2-hour Postmeal||-41.3|-65.1|<0.001
74097234|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-48.0|||<|0.001|TWO_SIDED|95.0|-58.6|-37.4|||Mixed Models Analysis|||Bedtime||-37.4|-58.6|<0.001
74097235|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-50.7|||<|0.001|TWO_SIDED|95.0|-61.3|-40.1|||Mixed Models Analysis|||Bedtime||-40.1|-61.3|<0.001
74097236|NCT03954834|147743416|SUPERIORITY||LS Mean Difference|-51.7|||<|0.001|TWO_SIDED|95.0|-62.6|-40.9|||Mixed Models Analysis|||||-40.9|-62.6|<0.001
73888094|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|8.8||||0.0283|TWO_SIDED|95.0|0.9|16.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.7|0.9|0.0283
74097237|NCT03954834|147743417|SUPERIORITY||Odds Ratio (OR)|12.4|||<|0.001|TWO_SIDED|95.0|6.43|23.94|||Regression, Logistic|||||23.94|6.43|<0.001
74097238|NCT03954834|147743417|SUPERIORITY||Odds Ratio (OR)|21.13|||<|0.001|TWO_SIDED|95.0|10.59|42.18|||Regression, Logistic|||||42.18|10.59|<0.001
74097239|NCT03954834|147743417|SUPERIORITY||Odds Ratio (OR)|20.1|||<|0.001|TWO_SIDED|95.0|10.09|40.04|||Regression, Logistic|||||40.04|10.09|<0.001
74097240|NCT03047330|147743422|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
74097241|NCT03047330|147743422|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74097242|NCT03047330|147743423|SUPERIORITY|||||||0.048|||||||Mixed Models Analysis|||||||0.048
74097243|NCT03047330|147743423|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||0.58
74097244|NCT04715932|147743462|SUPERIORITY||Odds Ratio (OR)|1.49||||0.3849|TWO_SIDED|95.0|0.6|3.69|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression).||||3.69|0.60|0.3849
74097245|NCT04715932|147743463|SUPERIORITY||Odds Ratio (OR)|1.43||||0.3139|TWO_SIDED|95.0|0.71|2.88|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.88|0.71|0.3139
74097246|NCT04715932|147743464|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5886|TWO_SIDED|95.0|0.65|2.14|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.14|0.65|0.5886
74097247|NCT04715932|147743465|SUPERIORITY||Odds Ratio (OR)|0.69||||0.2328|TWO_SIDED|95.0|0.38|1.27|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.27|0.38|0.2328
74097248|NCT04715932|147743466|SUPERIORITY||Rate Ratio|1.14||||0.156|TWO_SIDED|95.0|0.95|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression).||||1.37|0.95|0.1560
74097249|NCT04715932|147743467|SUPERIORITY||Rate Ratio|1.06||||0.6233|TWO_SIDED|95.0|0.84|1.33|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.33|0.84|0.6233
74097250|NCT04715932|147743468|SUPERIORITY||Rate Ratio|1.03||||0.829|TWO_SIDED|95.0|0.78|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.37|0.78|0.8290
74097251|NCT04715932|147743469|SUPERIORITY||Rate Ratio|0.98||||0.9222|TWO_SIDED|95.0|0.69|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.40|0.69|0.9222
74097252|NCT04715932|147743470|SUPERIORITY|||||||0.8834|||||||Log Rank|||||||0.8834
74097253|NCT04715932|147743471|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9416|TWO_SIDED|95.0|0.59|1.77|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.77|0.59|0.9416
74097254|NCT04715932|147743472|SUPERIORITY||Odds Ratio (OR)|0.87||||0.6296|TWO_SIDED|95.0|0.49|1.55|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.55|0.49|0.6296
74097255|NCT04715932|147743473|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3711|TWO_SIDED|95.0|0.41|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.40|0.41|0.3711
74097256|NCT04715932|147743474|SUPERIORITY||Odds Ratio (OR)|0.82||||0.5696|TWO_SIDED|95.0|0.42|1.61|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.61|0.42|0.5696
74097257|NCT04715932|147743475|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7583|TWO_SIDED|95.0|0.26|2.67|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.67|0.26|0.7583
74097258|NCT04715932|147743476|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8091|TWO_SIDED|95.0|0.2|3.58|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.58|0.20|0.8091
74097259|NCT04715932|147743477|SUPERIORITY||Odds Ratio (OR)|1.67||||0.5591|TWO_SIDED|95.0|0.3|9.42|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||9.42|0.30|0.5591
74097260|NCT04715932|147743478|SUPERIORITY|||||||0.9983|||||||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||||0.9983
74097261|NCT04715932|147743479|SUPERIORITY||Odds Ratio (OR)|1.6||||0.1068|TWO_SIDED|95.0|0.9|2.82|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.82|0.90|0.1068
74097262|NCT04715932|147743480|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8382|TWO_SIDED|95.0|0.57|1.98|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.98|0.57|0.8382
74097263|NCT04715932|147743481|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5912|TWO_SIDED|95.0|0.59|2.51|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.51|0.59|0.5912
74097264|NCT04715932|147743483|SUPERIORITY||Odds Ratio (OR)|0.78||||0.3686|TWO_SIDED|95.0|0.45|1.35|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.35|0.45|0.3686
74047731|NCT02859558|147648091|SUPERIORITY|||||||0.97||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.97
74047732|NCT02859558|147648091|SUPERIORITY|||||||0.21||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.21
74047733|NCT02859558|147648091|SUPERIORITY|||||||0.12||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.12
74047734|NCT02859558|147648091|SUPERIORITY|||||||0.055||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.055
74047735|NCT02859558|147648091|SUPERIORITY|||||||0.28||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.28
74047736|NCT02859558|147648091|SUPERIORITY|||||||0.38||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.38
74047737|NCT02859558|147648091|SUPERIORITY|||||||0.35||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.35
74097265|NCT04715932|147743484|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8711|TWO_SIDED|95.0|0.59|1.86|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.86|0.59|0.8711
74047738|NCT02859558|147648091|SUPERIORITY|||||||0.007||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.007
74047739|NCT02859558|147648091|SUPERIORITY|||||||0.045||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.045
74047740|NCT02859558|147648091|SUPERIORITY|||||||0.085||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.085
74047741|NCT02859558|147648091|SUPERIORITY|||||||0.044||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.044
74047742|NCT02859558|147648091|SUPERIORITY|||||||0.6||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.60
74047743|NCT02859558|147648092|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Joint Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
74047744|NCT02859558|147648092|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Joint Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
74047745|NCT02859558|147648092|SUPERIORITY|||||||0.64||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||0.64
74047746|NCT02859558|147648092|SUPERIORITY|||||||0.69||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.69
74047747|NCT02859558|147648092|SUPERIORITY|||||||0.4||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.40
74047748|NCT02859558|147648092|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
74097266|NCT04715932|147743485|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9124|TWO_SIDED|95.0|0.57|1.87|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.87|0.57|0.9124
74097267|NCT04715932|147743486|SUPERIORITY||Odds Ratio (OR)|0.7||||0.2952|TWO_SIDED|95.0|0.36|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.37|0.36|0.2952
74097268|NCT04715932|147743487|SUPERIORITY||Odds Ratio (OR)|1.2||||0.5894|TWO_SIDED|95.0|0.62|2.34|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.34|0.62|0.5894
74097269|NCT04715932|147743488|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7887|TWO_SIDED|95.0|0.45|2.89|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.89|0.45|0.7887
74097270|NCT04715932|147743489|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6348|TWO_SIDED|95.0|0.2|2.7|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.70|0.20|0.6348
74097271|NCT04715932|147743490|SUPERIORITY||Odds Ratio (OR)|0.39||||0.4257|TWO_SIDED|95.0|0.04|3.92|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.92|0.04|0.4257
74097272|NCT04715932|147743491|SUPERIORITY||Odds Ratio (OR)|1.66||||0.1113|TWO_SIDED|95.0|0.89|3.11|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.11|0.89|0.1113
74097273|NCT04715932|147743492|SUPERIORITY||Odds Ratio (OR)|1.57||||0.2613|TWO_SIDED|95.0|0.71|3.47|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.47|0.71|0.2613
74097274|NCT04715932|147743493|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7273|TWO_SIDED|95.0|0.27|2.49|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.49|0.27|0.7273
74097275|NCT04715932|147743494|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8909|TWO_SIDED|95.0|0.19|4.19|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.19|0.19|0.8909
74097276|NCT04715932|147743495|SUPERIORITY||Odds Ratio (OR)|1.52||||0.1438|TWO_SIDED|95.0|0.87|2.67|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.67|0.87|0.1438
74047749|NCT02859558|147648092|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
74097277|NCT04715932|147743496|SUPERIORITY||Odds Ratio (OR)|1.38||||0.344|TWO_SIDED|95.0|0.71|2.68|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.68|0.71|0.3440
74047751|NCT00142818|147648164|SUPERIORITY|||||||0.4|||||||ANOVA|||||||0.4
74047752|NCT04852666|147648178|SUPERIORITY|||||||0.751|||||||t-test, 2 sided|||||||0.751
74047753|NCT04852666|147648178|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
74097278|NCT04715932|147743497|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5968|TWO_SIDED|95.0|0.58|2.56|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.56|0.58|0.5968
74097279|NCT04715932|147743498|SUPERIORITY||Odds Ratio (OR)|1.52||||0.362|TWO_SIDED|95.0|0.62|3.76|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.76|0.62|0.3620
74097280|NCT04715932|147743499|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0875|TWO_SIDED|95.0|0.91|4.27|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.27|0.91|0.0875
74097281|NCT04715932|147743500|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8397|TWO_SIDED|95.0|0.36|2.32|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.32|0.36|0.8397
74097282|NCT04715932|147743501|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6265|TWO_SIDED|95.0|0.4|4.65|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.65|0.40|0.6265
74097283|NCT04715932|147743502|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8528|TWO_SIDED|95.0|0.16|8.91|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||8.91|0.16|0.8528
74097284|NCT04715932|147743503|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2983|TWO_SIDED|95.0|0.77|2.35|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.35|0.77|0.2983
74097285|NCT04715932|147743504|SUPERIORITY||Odds Ratio (OR)|1.19||||0.5611|TWO_SIDED|95.0|0.66|2.16|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.16|0.66|0.5611
74097286|NCT04715932|147743505|SUPERIORITY||Odds Ratio (OR)|1.29||||0.4643|TWO_SIDED|95.0|0.65|2.58|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.58|0.65|0.4643
74097287|NCT04715932|147743506|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5063|TWO_SIDED|95.0|0.53|3.62|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.62|0.53|0.5063
74097288|NCT04715932|147743507|SUPERIORITY||Odds Ratio (OR)|1.41||||0.2292|TWO_SIDED|95.0|0.8|2.47|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.47|0.80|0.2292
74097289|NCT04715932|147743508|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6097|TWO_SIDED|95.0|0.65|2.07|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.07|0.65|0.6097
74097290|NCT04715932|147743509|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8389|TWO_SIDED|95.0|0.54|2.16|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.16|0.54|0.8389
74097291|NCT04715932|147743510|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9764|TWO_SIDED|95.0|0.45|2.17|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.17|0.45|0.9764
74097292|NCT04715932|147743511|SUPERIORITY||Odds Ratio (OR)|0.8||||0.4403|TWO_SIDED|95.0|0.46|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.40|0.46|0.4403
74097293|NCT04715932|147743512|SUPERIORITY||Odds Ratio (OR)|0.79||||0.5112|TWO_SIDED|95.0|0.39|1.6|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.60|0.39|0.5112
74097294|NCT04715932|147743513|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9306|TWO_SIDED|95.0|0.46|2.36|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.36|0.46|0.9306
74097295|NCT04715932|147743514|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6046|TWO_SIDED|95.0|0.23|2.36|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.36|0.23|0.6046
74097296|NCT04715932|147743515|SUPERIORITY||Odds Ratio (OR)|1.15||||0.6963|TWO_SIDED|95.0|0.57|2.34|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.34|0.57|0.6963
74097297|NCT04715932|147743516|SUPERIORITY||Odds Ratio (OR)|0.65||||0.425|TWO_SIDED|95.0|0.22|1.88|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.88|0.22|0.4250
74097298|NCT04715932|147743517|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8797|TWO_SIDED|95.0|0.27|4.65|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.65|0.27|0.8797
73880891|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.91||||0.0101|TWO_SIDED|95.0|1.46|16.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.53|1.46|0.0101
74047754|NCT04852666|147648179|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||||||0.778
74047755|NCT04852666|147648179|SUPERIORITY|||||||0.357|||||||t-test, 2 sided|||||||0.357
74047756|NCT04852666|147648180|SUPERIORITY|||||||0.012|||||||Chi-squared|||||||0.012
74047757|NCT04852666|147648180|SUPERIORITY|||||||0.956|||||||Chi-squared|||||||0.956
74047758|NCT04852666|147648181|SUPERIORITY|||||||0.103|||||||Chi-squared|||||||0.103
74047759|NCT04852666|147648181|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
74047760|NCT04852666|147648182|SUPERIORITY|||||||0.785|||||||t-test, 2 sided|||||||0.785
74047761|NCT04852666|147648183|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.200
74047762|NCT04852666|147648184|SUPERIORITY|||||||0.887|||||||t-test, 2 sided|||||||0.887
74047763|NCT04852666|147648184|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
74047764|NCT04960202|147648290|SUPERIORITY||Percentage difference|-6.137|STANDARD_ERROR_OF_MEAN|1.057|<|0.0001|TWO_SIDED|95.0|-8.208|-4.066|||Normal approximation|||The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.||-4.066|-8.208|<0.0001
74047765|NCT04960202|147648293|SUPERIORITY||Percentage difference|-5.638|STANDARD_ERROR_OF_MEAN|0.852|<|0.0001|TWO_SIDED|95.0|-7.308|-3.967|||Normal approximation|||The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.||-3.967|-7.308|<0.0001
74047766|NCT04960202|147648294|SUPERIORITY||Hazard Ratio (HR)|1.294||||0.0003|TWO_SIDED|95.0|1.136|1.476|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox proportional hazard (PH) model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 logarithm to base 10 \[log10\] copies/milliliter \[mL\], \>=4 log10 copies/mL) as covariates.||1.476|1.136|0.0003
74047767|NCT04960202|147648295|SUPERIORITY||Hazard Ratio (HR)|1.266|||<|0.0001|TWO_SIDED|95.0|1.134|1.412|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.412|1.134|<0.0001
74047768|NCT04960202|147648296|SUPERIORITY||Hazard Ratio (HR)|1.258|||<|0.0001|TWO_SIDED|95.0|1.131|1.4|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.400|1.131|<0.0001
74047769|NCT04960202|147648297|SUPERIORITY||Odds Ratio (OR)|0.871||||0.3473|TWO_SIDED|95.0|0.652|1.162|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.162|0.652|0.3473
74047770|NCT04960202|147648298|SUPERIORITY||Odds Ratio (OR)|0.936||||0.5762|TWO_SIDED|95.0|0.74|1.182|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.182|0.740|0.5762
74047771|NCT04960202|147648299|SUPERIORITY||Odds Ratio (OR)|0.969||||0.7807|TWO_SIDED|95.0|0.773|1.213|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No),baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.213|0.773|0.7807
74047772|NCT04960202|147648300|SUPERIORITY||Hazard Ratio (HR)|1.219||||0.0053|TWO_SIDED|95.0|1.061|1.401|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.401|1.061|0.0053
74047773|NCT04960202|147648301|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.0022|TWO_SIDED|95.0|1.068|1.348|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.348|1.068|0.0022
74047774|NCT04960202|147648302|SUPERIORITY||Hazard Ratio (HR)|1.194||||0.0021|TWO_SIDED|95.0|1.066|1.337|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.337|1.066|0.0021
74047775|NCT04960202|147648309|SUPERIORITY||Odds Ratio (OR)|1.088||||0.5293|TWO_SIDED|95.0|0.836|1.416|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.416|0.836|0.5293
74047776|NCT04960202|147648310|SUPERIORITY||Odds Ratio (OR)|1.053||||0.6379|TWO_SIDED|95.0|0.85|1.303|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.303|0.850|0.6379
74047777|NCT04960202|147648311|SUPERIORITY||Odds Ratio (OR)|1.046||||0.676|TWO_SIDED|95.0|0.848|1.29|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.290|0.848|0.6760
74097299|NCT04715932|147743518|SUPERIORITY||Odds Ratio (OR)|3.71||||0.2634|TWO_SIDED|95.0|0.37|37.03|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||37.03|0.37|0.2634
74047778|NCT04960202|147648312|SUPERIORITY||Odds Ratio (OR)|19.4||||0.1997||95.0|7.788|48.328|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||48.328|7.788|0.1997
74047779|NCT04960202|147648312|OTHER||Odds Ratio (OR)|8.948|||||TWO_SIDED|95.0|4.159|19.253|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: Placebo|||19.253|4.159|
74047780|NCT04960202|147648313|SUPERIORITY||Odds Ratio (OR)|20.875||||0.281|TWO_SIDED|95.0|10.097|43.156|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||43.156|10.097|0.2810
74047781|NCT04960202|147648313|SUPERIORITY||Odds Ratio (OR)|12.452|||||TWO_SIDED|95.0|6.823|22.725|||Breslow Day test||Odds ratio for Day 5 vs Day 1: Placebo|||22.725|6.823|
74047782|NCT04960202|147648314|SUPERIORITY||Odds Ratio (OR)|21.119||||0.2226|TWO_SIDED|95.0|10.412|42.837|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||42.837|10.412|0.2226
74047783|NCT04960202|147648314|SUPERIORITY||Odds Ratio (OR)|12.036||||0.2342|TWO_SIDED|95.0|6.808|21.28|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: Placebo|||21.280|6.808|0.2342
74047784|NCT03558828|147648342|OTHER|A power analysis based on the study's primary aim (impact of augmented treatments on non-responders) was conducted. An estimated effect size of d=0.41 for the difference between the two augmented treatments was used. With a 2-tailed alpha of 0.05, a pre-post correlation of r=0.60, and a sample size of 188 non-responders, an estimated 80% power was obtained. Assuming 67% non-response to the initial treatments and 10% attrition, the final target sample size was N=312.|Effect size estimates|0.41|||||TWO_SIDED|95.0||||All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|GEEs||Effect size estimates (Cohen's d) for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator.||"The longitudinal trajectories using generalized estimating equations (GEEs) were estimated. Cases for responders are duplicated and weighted based on the inverse probability of being assigned to a particular adaptive intervention (i.e., responders have a ½ probability of assignment to a specific adaptive intervention, and non-responders have a ¼ probability).~Only the Phase 1 (baseline to 8 weeks) treatment condition x time interaction was included because it preceded the randomization to Phase 2 (weeks 9-34) treatment conditions. Planned contrasts were used to test specific hypotheses. Effect size estimates for all analyses were created by using the relevant slope effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests."|||
74047785|NCT03558828|147648343|OTHER|A power analysis based on the study's primary aim (impact of augmented treatments on non-responders) was conducted. An estimated effect size of d=0.41 for the difference between the two augmented treatments was used. With a 2-tailed alpha of 0.05, a pre-post correlation of r=0.60, and a sample size of 188 non-responders, an estimated 80% power was obtained. Assuming 67% non-response to the initial treatments and 10% attrition, the final target sample size was N=312.|Effect size estimates|0.41|||||TWO_SIDED|95.0||||All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|GEEs||Effect size estimates for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. An estimated effect size of d=0.41 was used.||There were time slope terms for Phase 1 (baseline to 8-week assessment), Phase 2 (9-weeks to 34-week assessment), and Phase 3 (maintenance from 35-weeks to 50-week assessment). Also, there were interactions of condition and time slopes. For Phase 1, only the Phase 1 treatment condition x time interaction was included because it preceded the randomization to Phase 2 treatment conditions. Supplementary analyses were conducted to compare the trajectories of responders versus non-responders to the Phase 1 treatment. Effect size estimates for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. The resulting effect size is equivalent to a Cohen's d, representing mean change (or difference in change) in standard deviation units. All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|||
74047786|NCT01250899|147648347|SUPERIORITY_OR_OTHER||Percentage of 12-wk 25(OH)D ≥30ng/mL|70.0|||<|0.05|TWO_SIDED|95.0|60.0|80.0|||Exact binomial||The primary endpoint (mean change in 25(OH)D following 12 weeks of vitamin D repletion in vitamin D insufficient subjects) was dichotomized to success or failure to achieve a week twelve 25(OH)D level ≥30ng/mL.|We predicted that HIV-infected subjects would have a 70% twelve-week repletion success rate compared to 85% among historical controls.Eighty subjects provided 91% power to detect a 12-week repletion rate statistically different than 85% (95% confidence interval (CI) 60%, 80%).||80|60|<0.05
74047787|NCT03774875|147648353|SUPERIORITY||Adjusted Difference in Response Rates|31.9|STANDARD_ERROR_OF_MEAN|6.78|<|0.0001|TWO_SIDED|95.0|18.6|45.2|||Cochran-Mantel-Haenszel|The CMH (Cochran-Mantel-Haenszel) test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.|Adjusted difference (apremilast - placebo) in response rates calculated using the weighted average of the treatment differences across the strata with the CMH weights.|||45.2|18.6|<0.0001
74047788|NCT03774875|147648354|SUPERIORITY||Least Squares (LS) Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|0.95|<|0.0001|TWO_SIDED|95.0|-7.15|-3.43|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and baseline value as a covariate.|Difference in LS Means = Apremilast - Placebo|||-3.43|-7.15|<0.0001
74097300|NCT04715932|147743519|SUPERIORITY||Odds Ratio (OR)|1.5||||0.271|TWO_SIDED|95.0|0.73|3.06|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.06|0.73|0.2710
74097301|NCT04715932|147743520|SUPERIORITY||Odds Ratio (OR)|1.82||||0.1748|TWO_SIDED|95.0|0.77|4.3|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.30|0.77|0.1748
74097302|NCT04715932|147743521|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8513|TWO_SIDED|95.0|0.34|3.63|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.63|0.34|0.8513
74047789|NCT03774875|147648355|SUPERIORITY||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|14.12||0.0085|TWO_SIDED|95.0|-66.58|-10.14|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate variable.|LS Mean Difference = Apremilast - Placebo|||-10.14|-66.58|0.0085
74047790|NCT03774875|147648356|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-2.34|-0.86|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||-0.86|-2.34|<0.0001
74047791|NCT03774875|147648357|SUPERIORITY||LS Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|4.31||0.0003|TWO_SIDED|95.0|-24.63|-7.6|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||-7.60|-24.63|0.0003
74047792|NCT03774875|147648358|SUPERIORITY||Adjusted Difference in Response Rates|13.5|STANDARD_ERROR_OF_MEAN|6.3||0.0328|TWO_SIDED|95.0|1.1|25.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification of the 5 difficult to treat manifestation types at randomization.|The adjusted difference in response rates (Apremilast - Placebo) using the weighted average of the treatment differences across the strata with the CMH weights.|||25.8|1.1|0.0328
74047793|NCT03774875|147648359|SUPERIORITY||Adjusted Difference in Response Rates|37.0|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|24.1|49.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.|Adjusted difference (Apremilast - Placebo) in response rates using the weighted average of the treatment differences across the strata with the CMH weights.|||49.9|24.1|<0.0001
74047794|NCT03774875|147648360|SUPERIORITY||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|18.55||0.4216|TWO_SIDED|95.0|-21.62|51.48|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||51.48|-21.62|0.4216
74047795|NCT03774875|147648361|SUPERIORITY||LS Mean Difference|-148.024|STANDARD_ERROR_OF_MEAN|103.9525||0.1559|TWO_SIDED|95.0|-352.8793|56.8304|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||56.8304|-352.8793|0.1559
74047796|NCT03774875|147648362|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.82||0.2667|TWO_SIDED|95.0|-2.43|8.73|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||8.73|-2.43|0.2667
74047797|NCT03774875|147648363|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.23||0.562|TWO_SIDED|95.0|-10.83|5.91|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||5.91|-10.83|0.5620
74047798|NCT03774875|147648364|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|4.81||0.8927|TWO_SIDED|95.0|-10.16|8.86|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||8.86|-10.16|0.8927
74047799|NCT03774875|147648365|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|4.09||0.0572|TWO_SIDED|95.0|-15.9|0.24|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||0.24|-15.90|0.0572
74047800|NCT05706623|147648391|OTHER|Analysis of variance model|Geometric least squares (LS) mean ratio|0.8354|||||TWO_SIDED|90.0|0.5216|1.338||||||Moderate Hepatic Impairment Group (test) versus Normal Hepatic Function Group (reference). The analysis was performed on natural log (ln) transformed parameters using an analysis of variance model with the hepatic function group as a fixed effect.||1.338|0.5216|
74047801|NCT05706623|147648393|OTHER|Analysis of variance model|Geometric LS Mean Ratio|0.9356|||||TWO_SIDED|90.0|0.5889|1.4864||||||Moderate Hepatic Impairment Group (test) versus Normal Hepatic Function Group (reference). The analysis was performed on ln transformed parameters using an analysis of variance model with the hepatic function group as a fixed effect.||1.4864|0.5889|
74047802|NCT00435929|147648400|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.656|||||TWO_SIDED|90.0|0.268|1.603||||||Comparison between normal liver function and moderate hepatic impairment for SQV||1.603|0.268|
74047803|NCT00435929|147648400|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.764|||||TWO_SIDED|90.0|0.505|1.156||||||Comparison between normal liver function and moderate hepatic impairment for RTV.||1.156|0.505|
74047804|NCT00435929|147648401|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.716|||||TWO_SIDED|90.0|0.311|1.644||||||Comparison between normal liver function and moderate hepatic impairment for SQV.||1.644|0.311|
74047805|NCT00435929|147648401|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.844|||||TWO_SIDED|90.0|0.551|1.292||||||Comparison between normal liver function and moderate hepatic impairment for RTV.||1.292|0.551|
74097303|NCT04715932|147743522|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7906|TWO_SIDED|95.0|0.29|5.07|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||5.07|0.29|0.7906
74047806|NCT00576147|147648421|SUPERIORITY_OR_OTHER||Percent Sensitivity|88.0|||||TWO_SIDED|95.0|75.0|95.0||||||||95.0|75.0|
74047807|NCT00576147|147648421|SUPERIORITY_OR_OTHER||Percent Specificity|90.7|||||TWO_SIDED|95.0|86.4|93.7||||||||93.7|86.4|
74097304|NCT03783039|147743574|NON_INFERIORITY|10% margin|Risk Difference (RD)|0.0605|||<|0.0001|ONE_SIDED|97.5|-0.0189|||Testing whether the group difference in proportion of successes is \>-0.1 (Test Group - Control Group)|Farrington-Manning method||||||-0.0189|<0.0001
74047808|NCT02219516|147648435|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|153.0|||||TWO_SIDED|90.0|115.0|203.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||203|115|
74047809|NCT02219516|147648435|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|173.0|||||TWO_SIDED|90.0|131.0|230.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||230|131|
74047810|NCT02219516|147648435|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|228.0|||||TWO_SIDED|90.0|155.0|336.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||336|155|
74097305|NCT03783039|147743575|OTHER||Difference in proportion of successes|0.0992|||||TWO_SIDED|95.0|0.0078|0.1906|||Farrington-Manning Method|Difference in proportion of successes (Test Group - Control Group)||||0.1906|0.0078|
74097306|NCT03783039|147743576|OTHER||Difference in proportion of successes|0.0275|||||TWO_SIDED|95.0|-0.0312|0.0863|||Farrington-Manning Method|Difference in proportion of successes (Test Group - Control Group)||||0.0863|-0.0312|
74018601|NCT02986230|147589226|SUPERIORITY||Odds Ratio (OR)|1.07||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index for breast, cervical, and colorectal cancer. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two contrasts were 2-sided with P-values \< 0.025 considered statistically significant.||||.025
74018602|NCT02986230|147589226|SUPERIORITY||Odds Ratio (OR)|0.91||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index date for breast, cervical, and colorectal cancer. Model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in randomization process. Tests of the planned contrasts were 2-sided with P-values \< 0.025 considered statistically significant.||||.025
74018603|NCT02986230|147589227|SUPERIORITY||Odds Ratio (OR)|1.04||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of the HPV vaccination series by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
74018604|NCT02986230|147589227|SUPERIORITY||Odds Ratio (OR)|0.71||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of the HPV vaccination series by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
74018605|NCT02986230|147589228|SUPERIORITY||Odds Ratio (OR)|1.55||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of lung cancer screening by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
74018606|NCT02986230|147589228|SUPERIORITY||Odds Ratio (OR)|1.02||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the intervention effect on the completion of lung cancer screening by 12 months post-index. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
74018607|NCT03434379|147589242|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0006|TWO_SIDED|95.0|0.42|0.79|||Log Rank|||At CCOD 18 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).||0.79|0.42|0.0006
74018608|NCT03434379|147589242|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0009|TWO_SIDED|95.0|0.52|0.85|||Log Rank|||At CCOD 30 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).||0.85|0.52|0.0009
74018609|NCT03434379|147589243|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.76|0.47|<0.0001
74097307|NCT00918138|147743594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|7.01||0.1278|TWO_SIDED|95.0|-24.8|3.2||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg|With at least 36 participants per treatment group (72 total), there is 90% power to detect a difference of 18 mg/dL between the two treatment groups. Assuming approximately 20% of participants will discontinue without any valid post-randomization assessment at Week 4, a total of 90 participants (45 participants per treatment group) needed to be randomized.||3.2|-24.8|0.1278
74097308|NCT00918138|147743595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1|STANDARD_ERROR_OF_MEAN|11.8|||TWO_SIDED|95.0|-54.6|-7.7||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure.|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg.|||-7.7|-54.6|
74097309|NCT00918138|147743596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|7.18|||TWO_SIDED|95.0|-20.0|8.5||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure.|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model.|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg|||8.5|-20.0|
74097310|NCT00699374|147743599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.9993|TWO_SIDED|95.0|1.14|1.5||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior transarterial chemoembolization (TACE) and tumor invasion condition.|Log Rank|||||1.50|1.14|0.9993
74097311|NCT00699374|147743600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8857|TWO_SIDED|95.0|0.99|1.3||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE, and tumor invasion condition|Log Rank|||||1.30|0.99|0.8857
74097312|NCT00699374|147743601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8459|TWO_SIDED|95.0|0.98|1.31||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE and tumor invasion condition|Log Rank|||||1.31|0.98|0.8459
74097313|NCT02885181|147743607|SUPERIORITY||Least Squares (LS) Means of Differences|0.01||||0.978|TWO_SIDED|95.0||0.76|||Cochran-Mantel-Haenszel|||||0.76|- 0.74|0.978
74097314|NCT02885181|147743607|SUPERIORITY||LS Means of Differences|0.4||||0.3|TWO_SIDED|95.0||1.16|||Cochran-Mantel-Haenszel|||||1.16|- 0.36|0.300
74097315|NCT02885181|147743607|SUPERIORITY||LS Means of Differences|0.0||||0.002|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||- 0.43|- 1.92|0.002
74097316|NCT02885181|147743608|SUPERIORITY||Difference in Response Rates|-5.9||||0.66|TWO_SIDED|95.0|-36.0|24.0|||Cochran-Mantel-Haenszel|||||24.0|-36.0|0.660
74097317|NCT02885181|147743608|SUPERIORITY||Difference in Response Rates|-15.9||||0.277|TWO_SIDED|95.0|-44.7|13.8|||Cochran-Mantel-Haenszel|||||13.8|-44.7|0.277
74097318|NCT02885181|147743608|SUPERIORITY||Difference in Response Rates|40.0||||0.009|TWO_SIDED|95.0|10.7|65.6|||Cochran-Mantel-Haenszel|||||65.6|10.7|0.009
74097319|NCT02885181|147743609|SUPERIORITY||Difference in Response Rates|-2.7||||0.853|TWO_SIDED|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel|||||27.5|-32.0|0.853
74097320|NCT02885181|147743609|SUPERIORITY||Difference in Response Rates|-2.7||||0.852|TWO_SIDED|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel|||||27.5|-32.0|0.852
74097321|NCT02885181|147743609|SUPERIORITY||Difference in Response Rates|24.9||||0.092|TWO_SIDED|95.0|-6.6|51.5|||Cochran-Mantel-Haenszel|||||51.5|-6.6|0.092
74097322|NCT02885181|147743610|SUPERIORITY||Difference in Response Rates|-8.6||||0.36|TWO_SIDED|95.0|-37.9|22.5|||Cochran-Mantel-Haenszel|||||22.5|-37.9|0.360
74097323|NCT02885181|147743610|SUPERIORITY||Difference in Response Rates|1.4||||0.896|TWO_SIDED|95.0|-28.0|31.7|||Cochran-Mantel-Haenszel|||||31.7|-28.0|0.896
74097324|NCT02885181|147743610|SUPERIORITY||Difference in Response Rates|24.5||||0.072|TWO_SIDED|95.0|-6.6|50.1|||Cochran-Mantel-Haenszel|||||50.1|-6.6|0.072
74097325|NCT02885181|147743611|SUPERIORITY||LS Means of Differences|-0.12||||0.528|TWO_SIDED|95.0|-0.49|0.25|||Cochran-Mantel-Haenszel|||||0.25|-0.49|0.528
74097326|NCT02885181|147743611|SUPERIORITY||LS Means of Differences|0.2||||0.293|TWO_SIDED|95.0|-0.17|0.57|||Cochran-Mantel-Haenszel|||||0.57|-0.17|0.293
74097327|NCT02885181|147743611|SUPERIORITY||LS Means of Differences|-0.33||||0.072|TWO_SIDED|95.0|-0.7|0.03|||Cochran-Mantel-Haenszel|||||0.03|-0.70|0.072
74097328|NCT01517373|147743613|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.145||0.4468|TWO_SIDED|80.0|-0.21|0.17||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment,duration of type 2 diabetes mellitus (T2DM),time and treatment-by-time interaction as fixed effects,baseline as the covariate,time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.17|-0.21|0.4468
74097329|NCT01517373|147743613|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.146||0.0218|TWO_SIDED|80.0|-0.48|-0.11||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.11|-0.48|0.0218
74047811|NCT02219516|147648437|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|131.0|||||TWO_SIDED|90.0|98.6|174.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||174|98.6|
74047812|NCT02219516|147648437|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|222.0|||||TWO_SIDED|90.0|171.0|287.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||287|171|
74047813|NCT02219516|147648437|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|211.0|||||TWO_SIDED|90.0|139.0|319.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||319|139|
74047814|NCT02219516|147648438|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|124.0|||||TWO_SIDED|90.0|88.8|173.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||173|88.8|
74047815|NCT02219516|147648438|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|248.0|||||TWO_SIDED|90.0|168.0|366.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||366|168|
74047816|NCT02219516|147648438|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|230.0|||||TWO_SIDED|90.0|146.0|363.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||363|146|
74047817|NCT02219516|147648440|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|76.0|||||TWO_SIDED|90.0|57.1|101.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||101|57.1|
74047818|NCT02219516|147648440|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|45.1|||||TWO_SIDED|90.0|34.9|58.3|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||58.3|34.9|
74047819|NCT02219516|147648440|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|47.8|||||TWO_SIDED|90.0|31.5|72.5|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||72.5|31.5|
74047820|NCT02219516|147648441|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|80.8|||||TWO_SIDED|90.0|57.9|113.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||113|57.9|
74047821|NCT02219516|147648441|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|40.3|||||TWO_SIDED|90.0|27.3|59.5|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||59.5|27.3|
74047822|NCT02219516|147648441|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|43.5|||||TWO_SIDED|90.0|27.5|68.7|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||68.7|27.5|
74047823|NCT02219516|147648442|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.4|||||TWO_SIDED|90.0|60.6|150.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||150|60.6|
74047824|NCT02219516|147648442|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|58.3|||||TWO_SIDED|90.0|30.2|113.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||113|30.2|
74097330|NCT01517373|147743613|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.144||0.0006|TWO_SIDED|80.0|-0.65|-0.28||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.28|-0.65|0.0006
74047825|NCT02219516|147648442|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|21.2|||||TWO_SIDED|90.0|13.6|32.8|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||32.8|13.6|
74047826|NCT01933399|147648443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4||||0.01|TWO_SIDED|95.0|2.2|16.6|||ANCOVA||"Difference in mean change in scores from baseline to follow-up by treatment group with no adjusment for baseline.~a priori threshold determined to be .05. no adjustments for multiple comparisons."|ANCOVA Adjusted for baseline score||16.6|2.2|.01
74047827|NCT01933399|147648443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.16|TWO_SIDED|95.0|-2.0|12.6||a priori threshold determined to be .05. no adjustments for multiple comparisons.|ANCOVA|Adjustment for baseline.||||12.6|-2.0|.16
74097331|NCT01517373|147743613|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.144|<|0.0001|TWO_SIDED|80.0|-1.02|-0.65||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.65|-1.02|<0.0001
74097332|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.087||0.6112|TWO_SIDED|80.0|-0.09|0.14||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.14|-0.09|0.6112
74097333|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.088||0.055|TWO_SIDED|80.0|-0.25|-0.03||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.03|-0.25|0.0550
74097334|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.086||0.0032|TWO_SIDED|80.0|-0.35|-0.13||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80%CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.13|-0.35|0.0032
74097335|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.086|<|0.0001|TWO_SIDED|80.0|-0.55|-0.33||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.33|-0.55|<0.0001
74097336|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.101||0.6146|TWO_SIDED|80.0|-0.1|0.16||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.16|-0.10|0.6146
74097337|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.2606|TWO_SIDED|80.0|-0.19|0.06||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.06|-0.19|0.2606
74097338|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.099||0.0006|TWO_SIDED|80.0|-0.45|-0.2||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.20|-0.45|0.0006
74097339|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|80.0|-0.7|-0.44||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.44|-0.70|<0.0001
74097340|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.118||0.6618|TWO_SIDED|80.0|-0.1|0.2||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.20|-0.10|0.6618
74097341|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.119||0.0878|TWO_SIDED|80.0|-0.31|-0.01||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.01|-0.31|0.0878
74097342|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.117||0.0022|TWO_SIDED|80.0|-0.49|-0.19||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.19|-0.49|0.0022
74097343|NCT01517373|147743614|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.117|<|0.0001|TWO_SIDED|80.0|-0.81|-0.51||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.51|-0.81|<0.0001
74097344|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|5.222||0.3446|TWO_SIDED|80.0|-8.8|4.62||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.62|-8.80|0.3446
74097345|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.12|STANDARD_ERROR_OF_MEAN|5.21||0.1204|TWO_SIDED|80.0|-12.81|0.57||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.57|-12.81|0.1204
74097346|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.74|STANDARD_ERROR_OF_MEAN|5.166||0.0041|TWO_SIDED|80.0|-20.37|-7.1||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.10|-20.37|0.0041
74097347|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.34|STANDARD_ERROR_OF_MEAN|5.192|<|0.0001|TWO_SIDED|80.0|-28.01|-14.67||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-14.67|-28.01|<0.0001
74097348|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.14|STANDARD_ERROR_OF_MEAN|5.191||0.1616|TWO_SIDED|80.0|-11.8|1.53||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.53|-11.80|0.1616
74097349|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.45|STANDARD_ERROR_OF_MEAN|5.219||0.1974|TWO_SIDED|80.0|-11.15|2.26||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.26|-11.15|0.1974
74097350|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.62|STANDARD_ERROR_OF_MEAN|5.14||0.0122|TWO_SIDED|80.0|-18.22|-5.02||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.02|-18.22|0.0122
74097351|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.79|STANDARD_ERROR_OF_MEAN|5.129|<|0.0001|TWO_SIDED|80.0|-31.37|-18.2||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-18.20|-31.37|<0.0001
73880892|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0572|TWO_SIDED|95.0|0.97|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.55|0.97|0.0572
74047828|NCT01933399|147648444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.01|TWO_SIDED|95.0|-2.3|-0.4|||ANCOVA|||Adjusted for baseline.||-0.4|-2.3|0.01
74047829|NCT01933399|147648444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.05|TWO_SIDED|95.0|-2.1|0.0|||ANCOVA|||Adjusted for baseline.||0|-2.1|.05
74047830|NCT03369704|147648452|OTHER||Least Square Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.44|-0.62||"H0: Omalizumab is not different to placebo with respect to mean nasal symptom score over the severe symptom period.~H1: Omalizumab is different to placebo with respect to mean nasal symptom score over the severe symptom period."|ANCOVA||nasal symptom score|||-0.62|-1.44|<0.001
74047831|NCT03369704|147648453|OTHER||ANCOVA|-1.89|STANDARD_ERROR_OF_MEAN|0.331|||TWO_SIDED|95.0|-2.55|-1.24|||||Nasal Ocular Symptom|||-1.24|-2.55|
74047832|NCT03369704|147648453|OTHER||ANCOVA|-0.87|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-1.18|-0.55|||||Ocular symptom|||-0.55|-1.18|
74047833|NCT03369704|147648454|OTHER||ANCOVA|-1.1|STANDARD_ERROR_OF_MEAN|0.229|||TWO_SIDED|95.0|-1.55|-0.64|||||nasal symptom medication score|||-0.64|-1.55|
74047834|NCT03369704|147648454|OTHER||ANCOVA|-0.95|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|-1.32|-0.58|||||ocular symptom medication score|||-0.58|-1.32|
74047835|NCT03369704|147648454|OTHER||ANCOVA|-2.05|STANDARD_ERROR_OF_MEAN|0.375|||TWO_SIDED|95.0|-2.78|-1.31|||||nasal ocular symptom medication score|||-1.31|-2.78|
74047836|NCT03369704|147648455|OTHER||ANCOVA|-0.4|STANDARD_ERROR_OF_MEAN|0.073|||TWO_SIDED|95.0|-0.54|-0.26|||||sneezing score|||-0.26|-0.54|
74047837|NCT03369704|147648455|OTHER||ANCOVA|-0.34|STANDARD_ERROR_OF_MEAN|0.088|||TWO_SIDED|95.0|-0.51|-0.16|||||rhinorrhea score|||-0.16|-0.51|
74047838|NCT03369704|147648455|OTHER||ANCOVA|-0.29|STANDARD_ERROR_OF_MEAN|0.081|||TWO_SIDED|95.0|-0.45|-0.13|||||nasal congestion score|||-0.13|-0.45|
74047839|NCT03369704|147648456|OTHER||ANCOVA|-0.47|STANDARD_ERROR_OF_MEAN|0.084|||TWO_SIDED|95.0|-0.63|-0.3|||||itchy eye score|||-0.30|-0.63|
74047840|NCT03369704|147648456|OTHER||ANCOVA|-0.4|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|95.0|-0.57|-0.23|||||watery eye score|||-0.23|-0.57|
74097352|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|5.674||0.3645|TWO_SIDED|80.0|-9.26|5.32||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.32|-9.26|0.3645
74097353|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.93|STANDARD_ERROR_OF_MEAN|5.676||0.3672|TWO_SIDED|80.0|-9.22|5.36||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.36|-9.22|0.3672
74097354|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|5.598||0.0906|TWO_SIDED|80.0|-14.69|-0.31||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.31|-14.69|0.0906
74097355|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.69|STANDARD_ERROR_OF_MEAN|5.624||0.0003|TWO_SIDED|80.0|-26.91|-12.46||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-12.46|-26.91|0.0003
74047841|NCT03369704|147648457|OTHER||ANCOVA|-0.34|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.48|-0.2|||||score for impairment of daily activities|||-0.20|-0.48|
74047842|NCT03369704|147648458|OTHER||Hodges-Lehmann Estimate|3.0|STANDARD_ERROR_OF_MEAN|1.02||0.005|TWO_SIDED|95.0|1.0|5.0|||van Elteren test||Nasal symptom free days|||5.0|1.0|0.005
74047843|NCT03369704|147648458|OTHER||Hodges-Lehmann Estimate|4.0|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|2.0|6.5|||van Elteren test||Ocular symptom free days|||6.5|2.0|<0.001
74047844|NCT03369704|147648459|OTHER||Odds Ratio (OR)|3.43||||0.005|TWO_SIDED|95.0|1.21|9.75|||logistic regression||Completely nasal symptom free patients|||9.75|1.21|0.005
74047845|NCT03369704|147648460|OTHER||ANCOVA|-0.08|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.14|-0.01|||||Nasal rescue mediation score|||-0.01|-0.14|
74047846|NCT03369704|147648460|OTHER||ANCOVA|-0.08|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.16|0.0|||||Ocular rescue medication score|||0.00|-0.16|
74047847|NCT03369704|147648460|OTHER||ANCOVA|-0.16|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.28|-0.04|||||Nasal ocular rescue medication score|||-0.04|-0.28|
74047848|NCT03369704|147648461|OTHER||Hodges-Lehmann Estimate|1.5|STANDARD_ERROR_OF_MEAN|0.89||0.011|TWO_SIDED|95.0|0.0|3.5|||van Elteren test||Nasal rescue mediation free days|||3.5|0.0|0.011
74047849|NCT03369704|147648461|OTHER||Hodges-Lehmann Estimate|2.0|STANDARD_ERROR_OF_MEAN|1.21||0.074|TWO_SIDED|95.0|0.0|4.8|||van Elteren test||Ocular rescue medication free days|||4.8|0.0|0.074
74047850|NCT03369704|147648461|OTHER||Hodges-Lehmann Estimate|1.8|STANDARD_ERROR_OF_MEAN|1.02||0.098|TWO_SIDED|95.0|0.0|4.0|||van Elteren test||Nasal ocular rescue medication free days|||4.0|0.0|0.098
74047851|NCT03369704|147648462|OTHER||Hodges-Lehmann Estimate|-2.0|STANDARD_ERROR_OF_MEAN|1.15||0.006|TWO_SIDED|95.0|-4.5|0.0|||van Elteren test||Nasal rescue mediation used|||0.0|-4.5|0.006
74047852|NCT03369704|147648462|OTHER||Hodges-Lehmann Estimate|-7.0|STANDARD_ERROR_OF_MEAN|2.81||0.012|TWO_SIDED|95.0|-12.0|-1.0|||van Elteren test||Ocular rescue medication used|||-1.0|-12.0|0.012
74047853|NCT03369704|147648463|OTHER||ANCOVA|-0.5|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|95.0|-0.66|-0.33|||||JRQLQ I|||-0.33|-0.66|
74047854|NCT03369704|147648463|OTHER||ANCOVA|-0.51|STANDARD_ERROR_OF_MEAN|0.093|||TWO_SIDED|95.0|-0.69|-0.33|||||JRQLQ II|||-0.33|-0.69|
74047855|NCT03369704|147648463|OTHER||ANCOVA|-0.6|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.8|-0.4|||||JRQLQ III|||-0.4|-0.8|
74047856|NCT03797144|147648491|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.06|||||||t-test, 1 sided|||"To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline."||||0.06
74047857|NCT03797144|147648491|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.012|||||||t-test, 1 sided|||"To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline."||||0.012
73888095|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7||||0.4861|TWO_SIDED|95.0|-10.5|5.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.0|-10.5|0.4861
74047858|NCT03797144|147648492|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.002||||||Back Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||0.002
74047859|NCT03797144|147648492|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Back Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
74047860|NCT03797144|147648492|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Leg Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
74047861|NCT03797144|147648492|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Leg Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
74097356|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.18|STANDARD_ERROR_OF_MEAN|5.534||0.1748|TWO_SIDED|80.0|-12.29|1.93||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.93|-12.29|0.1748
74047862|NCT03797144|147648493|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.174||||||Health State Score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.174
74047863|NCT03797144|147648493|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.002||||||Health State Score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.002
74097357|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.54|STANDARD_ERROR_OF_MEAN|5.566||0.0297|TWO_SIDED|80.0|-17.69|-3.38||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.38|-17.69|0.0297
74097358|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.44|STANDARD_ERROR_OF_MEAN|5.469||0.0118|TWO_SIDED|80.0|-19.47|-5.41||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.41|-19.47|0.0118
74047864|NCT03797144|147648493|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.003||||||Index score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.003
74047865|NCT03797144|147648493|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.012||||||Index score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.012
74047866|NCT00995215|147648517|OTHER|Statistical analysis was performed using a repeated measures analysis of variance and paired t-test.||||||0.05||||||A P value \<0.05 was taken as indicative of statistical significance.|ANOVA|||The effects of electrical (spinal cord stimulation) SCS with disc electrode and wire leads on airway pressure generation were compared. Since SCS with the disc leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.||||0.05
74047867|NCT01678560|147648537|OTHER|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|TWO_SIDED|||||Hypothesis: Active continuous monitoring of PAP treatment in OSA will result in improved adherence at 90 days Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|Exact Fisher test was used on the information from the limited population.||PAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department. The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.|Exact Fisher test was used on the collected information from the limited population.|||<0.01
74047868|NCT01678560|147648538|OTHER|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|TWO_SIDED|||||"Hypothesis: Active continuous monitoring of PAP treatment in OSA (Wireless group) will result in improved adherence at 90 days compared to Usual Group.~Exact Fisher test was used on the collected information from the limited population."|Fisher Exact|Exact Fisher test was used on the information from the limited population||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm|Exact Fisher test was used on the collected information from the limited population|||<0.01
74097359|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.0|STANDARD_ERROR_OF_MEAN|5.48|<|0.0001|TWO_SIDED|80.0|-34.04|-19.96||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-19.96|-34.04|<0.0001
74097360|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.03|STANDARD_ERROR_OF_MEAN|6.281||0.1012|TWO_SIDED|80.0|-16.1|0.04||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.04|-16.10|0.1012
74047869|NCT01678560|147648539|OTHER|Exact Fisher test was used on the collected information from the limited population|Estimation Parameter Other[Fisher exact|1.0|||<|0.01|TWO_SIDED|||||Hypothesis - Number of patients effectively treated with the PAP will be higher in the Wireless Group compared to the Usual Group Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.||||<0.01
74047870|NCT01678560|147648540|OTHER|Exact Fisher test was used on the collected information from the limited population|Other[Fisher exact test statistic value]|0.0286|||<|0.01|TWO_SIDED|||||Hypothesis - PAP treatment Adherence in the first 3 months of treatment predicts the PAP treatment Adherence in the next 9 months of treatment Exact Fisher test was used on the collected information from the limited population|Fisher Exact||Exact Fisher test was used on the collected information from the limited population.|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population.|||<0.01
74047871|NCT01678560|147648541|OTHER|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test|0.0039|||<|0.01|TWO_SIDED|||||"Hypothesis: Patients with the higher AHI are more likely to become adherent to the PAP therapy.~Exact Fisher test was used on the collected information from the limited population"|Fisher Exact|Exact Fisher test was used on the collected information from the limited population||Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population|||<0.01
74047872|NCT03296072|147648558|OTHER||Difference of Least Square mean|7.69|||<|0.0001|TWO_SIDED|95.0|5.18|10.19|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||10.19|5.18|<.0001
74047873|NCT03296072|147648559|OTHER||Difference of Least Square mean|33.29|||<|0.0001|TWO_SIDED|95.0|28.89|37.68|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||37.68|28.89|<.0001
74047874|NCT03296072|147648560|OTHER||Difference of Least Square mean|1.81|||<|0.0001|TWO_SIDED|95.0|1.59|2.04|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||2.04|1.59|<.0001
74047875|NCT03296072|147648561|OTHER||Difference of Least Square mean|7.57|||<|0.0001|TWO_SIDED|95.0|5.07|11.07|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||11.07|5.07|<.0001
74047876|NCT03296072|147648562|OTHER||Difference of Least Square mean|10.98|||<|0.0001|TWO_SIDED|95.0|6.58|15.37|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||15.37|6.58|<.0001
74047877|NCT03296072|147648563|OTHER||Difference of Least Square mean|0.97|||<|0.0001|TWO_SIDED|95.0|0.75|1.2|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||1.20|0.75|<.0001
74097361|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.99|STANDARD_ERROR_OF_MEAN|6.287||0.0409|TWO_SIDED|80.0|-19.07|-2.91|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.91|-19.07|0.0409
74047878|NCT00654368|147648564|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the one-sided 95% confidence interval (CI), defined below, exceeded the noninferiority margin of -0.6, then noninferiority was to be concluded.|Mean Difference|-0.41|||||TWO_SIDED|95.0|-0.75|-0.06|||||The 95% CI was calculated using the mean square error from an analysis of variance (ANOVA) fitted with effects for treatment and covariates of duration of disease, type of reimbursement, and 6 month DAS28.|||-0.06|-0.75|
74047879|NCT00804986|147648577|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.47||||0.0109|TWO_SIDED|95.0|-0.83|-0.11||p-value represents change from baseline to Week 12 HbA1c for 0.5 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.11|-0.83|0.0109
74047880|NCT00804986|147648577|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.67||||0.0003|TWO_SIDED|95.0|-1.02|-0.31||p-value represents change from baseline to week 12 HbA1c for 2.0 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.31|-1.02|0.0003
74047881|NCT00804986|147648577|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.76||p-value represents change from baseline to Week 12 HbA1c for 6.2 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.76|-1.46|<0.0001
74097362|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.87|STANDARD_ERROR_OF_MEAN|6.232||0.0089|TWO_SIDED|80.0|-22.88|-6.86|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-6.86|-22.88|0.0089
74097363|NCT01517373|147743615|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.93|STANDARD_ERROR_OF_MEAN|6.233|<|0.0001|TWO_SIDED|80.0|-33.93|-17.92||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-17.92|-33.93|<0.0001
73880893|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7348|TWO_SIDED|95.0|0.44|3.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||3.20|0.44|0.7348
74047882|NCT00804986|147648577|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.64|-0.93||p-value represents change from baseline to Week 12 HbA1c for 12.0 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.93|-1.64|<0.0001
74047883|NCT00804986|147648577|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.88||p-value represents change from baseline to Week 12 HbA1c for 17.6 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.88|-1.59|<0.0001
74047884|NCT00804986|147648578|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|1.93||||0.655||95.0||||p-value represents change from baseline to Week 12 for hunger, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.655
74047885|NCT00804986|147648578|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|3.36||||0.436||95.0||||p-value represents change from baseline to Week 12 for hunger, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.436
74047886|NCT00804986|147648578|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.45||||0.914||95.0||||p-value represents change from baseline to Week 12 for hunger, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.914
74047887|NCT00804986|147648578|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|3.3||||0.446||95.0||||p-value represents change from baseline to Week 12 for hunger, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.446
74047888|NCT00804986|147648578|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|2.84||||0.508||95.0||||p-value represents change from baseline to Week 12 for hunger, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.508
74047889|NCT00804986|147648578|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|2.89||||0.561||95.0||||p-value represents change from baseline to Week 12 for how full, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.561
74047890|NCT00804986|147648578|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-7.4||||0.135||95.0||||p-value represents change from baseline to Week 12 for how full, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.135
74047891|NCT00804986|147648578|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-4.45||||0.357||95.0||||p-value represents change from baseline to Week 12 for how full, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.357
74047892|NCT00804986|147648578|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-8.05||||0.105||95.0||||p-value represents change from baseline to Week 12 for how full, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.105
74047893|NCT00804986|147648578|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6.02||||0.221||95.0||||p-value represents change from baseline to Week 12 for how full, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.221
74047894|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-4.54||||0.4848||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4848
74047895|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-19.48||||0.0029||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0029
74047896|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-32.52|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047897|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-30.45|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047898|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.25|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047899|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-5.32||||0.6279||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.6279
74047900|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-29.72||||0.0072||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0072
74047901|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-42.49|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74097364|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.196||0.0898|TWO_SIDED|80.0|0.08|0.59||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, duration of type 2 diabetes mellitus (T2DM), time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|0.08|0.0898
74097365|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.195||0.0555|TWO_SIDED|80.0|0.12|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|0.12|0.0555
74047902|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-43.05||||0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
74047903|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-51.38|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047904|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-20.21||||0.0335||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0335
74047905|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-21.91||||0.0221||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0221
74047906|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-39.41|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047907|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-36.07||||0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0002
74047908|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.36|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047909|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6.41||||0.503||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.5030
74047910|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-12.49||||0.1938||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.1938
74097366|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.193||0.0585|TWO_SIDED|80.0|0.12|0.61||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.61|0.12|0.0585
74047911|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-33.13||||0.0003||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0003
74047912|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.66||||0.0101||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0101
74047913|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-43.47|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047914|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.69||||0.006||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0060
74047915|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-34.26||||0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0002
74047916|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-38.55|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047917|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.34|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
73880894|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.2||||0.1397|TWO_SIDED|95.0|0.77|6.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.25|0.77|0.1397
74047918|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-46.26|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047919|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-11.84||||0.2468||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.2468
74047920|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-21.13||||0.0413||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, visit, treatment and visit by treatment interaction as fixed effects||||||0.0413
74047921|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.19||||0.0004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0004
74047922|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-29.59||||0.004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0040
74047923|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-49.9|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047924|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.02||||0.0199||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0199
74047925|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.77||||0.0008||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0008
74047926|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-38.17||||0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
74047927|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.74||||0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
74047928|NCT00804986|147648581|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-53.16|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047929|NCT00804986|147648582|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1131.85||||0.4193||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4193
74047930|NCT00804986|147648582|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1471.04||||0.3026||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.3026
74047931|NCT00804986|147648582|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-5547.95|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047932|NCT00804986|147648582|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6116.19|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047933|NCT00804986|147648582|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-7786.69|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
74047934|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.08||||0.693||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.693
74047935|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.31||||0.104||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.104
74047936|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.13||||0.506||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.506
74047937|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.09||||0.648||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.648
74047938|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.09||||0.647||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.647
74018610|NCT03434379|147589244|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0026|TWO_SIDED|95.0|0.25|0.76|||Log Rank|||At CCOD 18 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.76|0.25|0.0026
74097367|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.194||0.0454|TWO_SIDED|80.0|0.14|0.64||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.64|0.14|0.0454
74018611|NCT03434379|147589244|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0019|TWO_SIDED|95.0|0.35|0.8|||Log Rank|||At CCOD 30 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.80|0.35|0.0019
74018612|NCT03434379|147589245|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0117|TWO_SIDED|95.0|0.4|0.9|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.90|0.40|0.0117
74018613|NCT03434379|147589246|SUPERIORITY||Odds Ratio (OR)|2.9|||<|0.0001|TWO_SIDED|95.0|1.68|5.01|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.01|1.68|<0.0001
74018614|NCT03434379|147589247|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.0001|TWO_SIDED|95.0|2.02|5.71|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.71|2.02|<0.0001
74018615|NCT03434379|147589248|SUPERIORITY||Odds Ratio (OR)|6.15|||<|0.0001|TWO_SIDED|95.0|2.99|12.66|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||12.66|2.99|<0.0001
74018616|NCT03434379|147589249|SUPERIORITY||Hazard Ratio (HR)|0.23||||0.0051|TWO_SIDED|95.0|0.08|0.7|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.70|0.08|0.0051
74018617|NCT03434379|147589250|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.0048|TWO_SIDED|95.0|0.12|0.73|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.73|0.12|0.0048
74018618|NCT03434379|147589251|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.4187|TWO_SIDED|95.0|0.16|2.15|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||2.15|0.16|0.4187
74018619|NCT03434379|147589252|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.74|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.74|0.46|<.0001
74018620|NCT03434379|147589253|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.36|0.57|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.57|0.36|<.0001
74018621|NCT03434379|147589254|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0105|TWO_SIDED|95.0|0.53|0.92|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.92|0.53|0.0105
74018622|NCT03434379|147589255|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0063|TWO_SIDED|95.0|0.52|0.9|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.90|0.52|0.0063
74018623|NCT03434379|147589256|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.57|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.57|0.35|<.0001
74018624|NCT03434379|147589257|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0019|TWO_SIDED|95.0|0.32|0.78|||Log Rank|||AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.78|0.32|0.0019
74018625|NCT03434379|147589257|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0879|TWO_SIDED|95.0|0.42|1.06|||Log Rank|||AFP \>/= 400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||1.06|0.42|0.0879
74018626|NCT03434379|147589258|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.37|0.68|||Log Rank|||AFP\<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.68|0.37|<.0001
74018627|NCT03434379|147589258|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.2159|TWO_SIDED|95.0|0.53|1.15|||Log Rank|||AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||1.15|0.53|0.2159
74018628|NCT03434379|147589259|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.31|0.57|||Log Rank|||AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.57|0.31|<0.0001
74018629|NCT03434379|147589259|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0002|TWO_SIDED|95.0|0.35|0.73|||Log Rank|||AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.73|0.35|0.0002
74018630|NCT03434379|147589260|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.39|0.73|||Log Rank|||Physical Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.73|0.39|<.0001
74097368|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.235||0.2819|TWO_SIDED|80.0|-0.05|0.55||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.55|-0.05|0.2819
74097369|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.235||0.0319|TWO_SIDED|80.0|0.2|0.81||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.81|0.20|0.0319
74097370|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.231||0.1835|TWO_SIDED|80.0|0.01|0.6||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.60|0.01|0.1835
74097371|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|0.231||0.0001|TWO_SIDED|80.0|0.63|1.22||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.22|0.63|0.0001
74097372|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.266||0.9689|TWO_SIDED|80.0|-0.35|0.33||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.33|-0.35|0.9689
74097373|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.265||0.2221|TWO_SIDED|80.0|-0.02|0.67||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.67|-0.02|0.2221
74097374|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.261||0.2774|TWO_SIDED|80.0|-0.05|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|-0.05|0.2774
74097375|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.263|<|0.0001|TWO_SIDED|80.0|0.76|1.43||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.43|0.76|<0.0001
74018631|NCT03434379|147589260|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0019|TWO_SIDED|95.0|0.46|0.84|||Log Rank|||Role Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.84|0.46|0.0019
74097376|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.314||0.0667|TWO_SIDED|80.0|0.17|0.98||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.98|0.17|0.0667
74097377|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.314||0.0133|TWO_SIDED|80.0|0.38|1.19||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.19|0.38|0.0133
74097378|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.308||0.026|TWO_SIDED|80.0|0.29|1.08||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.08|0.29|0.0260
74097379|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|80.0|1.23|2.02||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.02|1.23|<0.0001
74097380|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.374||0.0335|TWO_SIDED|80.0|0.32|1.28||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.28|0.32|0.0335
74097381|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.373||0.1557|TWO_SIDED|80.0|0.05|1.01||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.01|0.05|0.1557
74097382|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|STANDARD_ERROR_OF_MEAN|0.368||0.0132|TWO_SIDED|80.0|0.45|1.39||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.39|0.45|0.0132
74097383|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|80.0|2.2|3.15||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.15|2.20|<0.0001
74097384|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.394||0.0158|TWO_SIDED|80.0|0.45|1.46||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.46|0.45|0.0158
74097385|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.392||0.2132|TWO_SIDED|80.0|-0.01|0.99||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.99|-0.01|0.2132
74097386|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.387||0.0263|TWO_SIDED|80.0|0.37|1.36||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.36|0.37|0.0263
74097387|NCT01517373|147743623|SUPERIORITY_OR_OTHER||LS Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|80.0|2.12|3.12||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.12|2.12|<0.0001
74097388|NCT04562155|147743637|SUPERIORITY||||||=|0.0345||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: Emax model (ED50=30) Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0345
74097389|NCT04562155|147743637|SUPERIORITY||||||=|0.0376||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: Emax model (ED50=50) Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0376
74097390|NCT04562155|147743637|SUPERIORITY||||||=|0.0319||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: sigm. Emax model (ED50=30, h=3) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0319
74097391|NCT04562155|147743637|SUPERIORITY||||||=|0.0603||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: sigm. Emax model (ED50=60, h=5) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0603
74097392|NCT00790335|147743646|SUPERIORITY||Risk Ratio (RR)|0.96||||0.56|TWO_SIDED|95.0|0.82|1.11|||Cochran-Mantel-Haenszel|Adjusted for extent of DVT and for clinical center|Numerator: PCDT Arm; Denominator: Control Arm. Primary outcome = no statistically significant difference between the two arms.|||1.11|0.82|0.56
74097393|NCT00790335|147743647|SUPERIORITY||Risk Ratio (RR)|0.58||||0.38|TWO_SIDED|95.0|0.17|1.98|||Cochran-Mantel-Haenszel|Adjusted by extent of thrombus and clinical center|Numerator: PCDT Arm; Denominator: Control Arm. No statistically significant difference was seen.|||1.98|0.17|0.38
74097394|NCT00790335|147743648|SUPERIORITY||Risk Ratio (RR)|0.94||||0.39|TWO_SIDED|95.0|0.8|1.09|||Cochran-Mantel-Haenszel|Adjusted for thrombus extent and clinical center|No statistically significant difference was seen.|||1.09|0.80|0.39
74097395|NCT00790335|147743649|SUPERIORITY||Risk Ratio (RR)|0.73||||0.04|TWO_SIDED|95.0|0.54|0.98|||Cochran-Mantel-Haenszel|Adjusted by extent of DVT and clinical center|Numerator: PCDT Arm; Denominator: Control Arm|||0.98|0.54|0.04
74097396|NCT00790335|147743650|SUPERIORITY||Risk Ratio (RR)|6.18||||0.049|TWO_SIDED|95.0|0.78|49.2|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm. More major bleeding was observed in the PCDT Arm.|||49.2|0.78|0.049
74097397|NCT00790335|147743651|SUPERIORITY||Risk Ratio (RR)|1.52||||0.23|TWO_SIDED|95.0|0.76|3.01|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||3.01|0.76|0.23
74097398|NCT00790335|147743652|SUPERIORITY||Risk Ratio (RR)|2.64||||0.03|TWO_SIDED|95.0|1.04|6.68|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm. Bleeding was more frequent in the PCDT Arm.|||6.68|1.04|0.03
74097399|NCT00790335|147743653|SUPERIORITY||Risk Ratio (RR)|1.26||||0.25|TWO_SIDED|95.0|0.85|1.89|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||1.89|0.85|0.25
74097400|NCT00790335|147743654|SUPERIORITY||Risk Ratio (RR)|1.53||||0.5|TWO_SIDED|95.0|0.44|5.28|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm|||5.28|0.44|0.50
74097401|NCT00790335|147743655|SUPERIORITY||Risk Ratio (RR)|1.47||||0.09|TWO_SIDED|95.0|0.94|2.29|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||2.29|0.94|0.09
74097402|NCT00790335|147743657|SUPERIORITY||Risk Ratio (RR)|0.89||||0.83|TWO_SIDED|95.0|0.33|2.44|||Cochran-Mantel-Haenszel|||||2.44|0.33|0.83
74097403|NCT00790335|147743658|SUPERIORITY||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
74097404|NCT00790335|147743659|SUPERIORITY||Mean Difference (Net)|-1.17|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
74097405|NCT00790335|147743660|SUPERIORITY||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
74097406|NCT00790335|147743661|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.38||0.005|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.005
74097407|NCT00790335|147743662|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
74097408|NCT00790335|147743663|SUPERIORITY||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.23||0.01|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.01
74097409|NCT00790335|147743664|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
74097410|NCT00790335|147743665|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.26||0.03|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.03
74097411|NCT00790335|147743666|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|1.26||0.37|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference was seen in the degree of change from baseline to 24 months between the two treatment arms.|||||0.37
74018632|NCT03434379|147589260|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0028|TWO_SIDED|95.0|0.46|0.85|||Log Rank|||GHS/QoL: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.85|0.46|0.0028
74018633|NCT03434379|147589265|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0036|TWO_SIDED|95.0|1.53|13.86|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||13.86|1.53|0.0036
74018634|NCT03434379|147589266|SUPERIORITY||Odds Ratio (OR)|4.71||||0.0013|TWO_SIDED|95.0|1.72|12.87|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||12.87|1.72|0.0013
74018635|NCT03434379|147589267|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0052|TWO_SIDED|95.0|1.47|17.39|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||17.39|1.47|0.0052
74018636|NCT03434379|147589268|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.4581|TWO_SIDED|95.0|0.02|5.85|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.85|0.02|0.4581
74018637|NCT03434379|147589269|SUPERIORITY||Hazard Ratio (HR)|0.08||||0.01|TWO_SIDED|95.0|0.01|0.91|||Log Rank||Lower limit: \<0.01|Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.91|0.01|0.0100
74018638|NCT03434379|147589270|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.3477|TWO_SIDED|95.0|0.03|3.69|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||3.69|0.03|0.3477
74018639|NCT03434379|147589271|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0103|TWO_SIDED|95.0|0.4|0.89|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.89|0.40|0.0103
74018640|NCT03434379|147589272|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0002|TWO_SIDED|95.0|0.33|0.71|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.71|0.33|0.0002
74018641|NCT03434379|147589273|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0927|TWO_SIDED|95.0|0.43|1.07|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.07|0.43|0.0927
74018642|NCT03434379|147589274|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0861|TWO_SIDED|95.0|0.43|1.06|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.06|0.43|0.0861
74018643|NCT03434379|147589275|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0004|TWO_SIDED|95.0|0.33|0.74|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.74|0.33|0.0004
74018644|NCT03434379|147589276|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.0035|TWO_SIDED|95.0|0.26|0.78|||Log Rank|||Physical Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.78|0.26|0.0035
74018645|NCT03434379|147589276|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.2214|TWO_SIDED|95.0|0.42|1.23|||Log Rank|||Role Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.23|0.42|0.2214
74018646|NCT03434379|147589276|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0135|TWO_SIDED|95.0|0.32|0.88|||Log Rank|||GHS/QoL: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.88|0.32|0.0135
74018647|NCT03550066|147589281|NON_INFERIORITY|The non-inferiority limit, d, is selected as the largest difference that is clinically acceptable. Here the non-inferiority limit is d=.6 (a medium to large effect size).||||||0.18||||||Threshold for statistical significance: \<.05|t-test, 2 sided|||||||0.18
74018648|NCT03179436|147589343|OTHER||Percent Difference|2.4|||||TWO_SIDED|95.0|-8.7|14.1|||Percent Difference|Comparision based on Miettinen \& Nurminen method||||14.1|-8.7|
74018649|NCT00692211|147589358|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.01|TWO_SIDED|95.0|1.04|2.32||Not adjusted for multiple comparisons, a priori threshold of 0.05|Regression, Logistic|||Study powered to detect 10% difference in proportion of screening adherence based on alpha of 0.05, beta 0.20.||2.32|1.04|0.01
74047939|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.01||||0.781||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.781
74047940|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.401||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.401
74047941|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.03||||0.464||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.464
74047942|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.42||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.420
74047943|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.01||||0.762||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.762
74047944|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.738||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.738
74047945|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.14||||0.277||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.277
74047946|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.21||||0.094||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.094
74047947|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.792||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.792
74047948|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.21||||0.105||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.105
74047949|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.12||||0.403||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.403
74047950|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.799||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.799
74047951|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.32||||0.029||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.029
74047952|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.12||||0.439||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.439
74047953|NCT00804986|147648585|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.27||||0.062||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.062
74047954|NCT00804986|147648586|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.16||||0.8003||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.8003
74047955|NCT00804986|147648586|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.26||||0.6736||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.6736
74047956|NCT00804986|147648586|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.53||||0.0123||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0123
74047957|NCT00804986|147648586|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.44||||0.4771||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4771
74047958|NCT00804986|147648586|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-2.01||||0.0013||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0013
74047959|NCT00815776|147648591|NON_INFERIORITY_OR_EQUIVALENCE|The unadjusted reductions are straight arithmetic averages and are supplied for informational purposes only. The pooled variance is calculated from the unadjusted standard deviations, and the t statistic is calculated as described in Laster (2003) using an average sample size of 54 and 106 degrees of freedom.|||||<|0.0096|||||||student's t-test with 2n-2 DoF|||The LS means were used to calculate the test statistic for non-inferiority of the CID to the traditional splint device. The null hypothesis was that the reduction of CMI score for the CID is less than 80% of the reduction in the splint group. A significant p-value(\< 0.05) would reject this null hypothesis in favor of the alternative hypothesis that the CID demonstrated a reduction of at least 80% of that seen in the splint group.||||<0.0096
74047960|NCT00815776|147648592|NON_INFERIORITY_OR_EQUIVALENCE|Safety analyses were performed on the ITT population.||||||0.688|||||||t-test, 1 sided|||Safety analyses were performed on the ITT population. The safety of the CID was characterized by the proportion of subjects with all serious and non-serious study-related adverse events and Unanticipated Adverse Device Events (UADEs). In addition, summaries of the onset, duration, severity, treatment relatedness, and outcome of all adverse events were reported.||||0.688
74047961|NCT00815776|147648593|SUPERIORITY_OR_OTHER|||||||0.2995||||||From the pilot study, 50 subjects (CID arm) and 25 (exercise arm) were required for at least 80% power to detect a difference in the mean reduction in CMI scores between arms if muPassive is less than approximately 70% of that in the CID arm.|t-test, 2 sided|||A significant p-value for the treatment group effect would indicate that the CID group and Exercise group were significantly different, based on results of a two-sided t test for difference in means, with alpha=0.5, and allowing for unequal sample sizes.||||.2995
74047962|NCT00959699|147648595|SUPERIORITY_OR_OTHER||Strata-Adjusted Difference|33.7||||0.0008|TWO_SIDED|95.0|14.1|53.3||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% Confidence Interval (CI) is based on a Modified Koch approach which adjusted for Randomization Strata of Cirrhosis/Fibrosis (Yes or No). The adjustment of randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) was not possible due to sparse data.||53.3|14.1|0.0008
74047963|NCT00959699|147648596|SUPERIORITY_OR_OTHER||Observed Difference|34.2||||0.0007|TWO_SIDED|95.0|14.5|53.9||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% CI is based on the asymptotic normal approximation to the binomial distribution||53.9|14.5|0.0007
74047964|NCT02583360|147648601|SUPERIORITY|||||||0.008|||||||Chi-squared|||||||0.008
74047965|NCT02583360|147648602|SUPERIORITY|||||||0.907|||||||t-test, 2 sided|||||||0.907
74047966|NCT02583360|147648603|SUPERIORITY|||||||0.592|||||||t-test, 2 sided|||||||0.592
74047967|NCT04228445|147648604|SUPERIORITY||Odds Ratio (OR)|14.041|||<|0.0001|TWO_SIDED|95.0|7.394|26.662|||Score statistics for Type 3 GEE analysis|||||26.662|7.394|<0.0001
74047968|NCT04228445|147648604|SUPERIORITY||Odds Ratio (OR)|16.772|||<|0.0001|TWO_SIDED|95.0|8.625|32.617|||Score statistics for Type 3 GEE analysis|||||32.617|8.625|<0.0001
74047969|NCT04228445|147648605|OTHER||Percentage of Responders|87.8|||||TWO_SIDED|95.0|78.6|96.9|||||Missing data imputed as non-responder|||96.9|78.6|
74047970|NCT04228445|147648605|OTHER||Percentage of Responders|87.2|||||TWO_SIDED|95.0|77.7|96.8|||||Missing data imputed as non-responder|||96.8|77.7|
74097412|NCT00790335|147743667|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.16||0.99|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No difference was observed in the degree of change from baseline to 24 months in the two treatment groups.|||||0.99
74047971|NCT04228445|147648606|OTHER||percentage of satisfaction|89.8|||||TWO_SIDED|95.0|78.2|95.6||||||||95.6|78.2|
74047972|NCT04228445|147648606|OTHER||percentage of satisfaction|80.9|||||TWO_SIDED|95.0|67.5|89.6||||||||89.6|67.5|
74047973|NCT04228445|147648607|OTHER||median time to visualization (minutes)|6.0|||||TWO_SIDED|95.0|5.25|7.0||||||||7.00|5.25|
74047974|NCT04228445|147648607|OTHER||median time to visualization (minutes)|5.93|||||TWO_SIDED|95.0|5.12|7.0||||||||7.00|5.12|
74047975|NCT04228445|147648608|SUPERIORITY||Odds Ratio (OR)|19.532|||<|0.0001|TWO_SIDED|95.0|8.738|43.663|||Score statistics for Type 3 GEE analysis|||||43.663|8.738|<0.0001
74047976|NCT04228445|147648608|SUPERIORITY||Odds Ratio (OR)|15.73|||<|0.0001|TWO_SIDED|95.0|7.199|34.369|||Score statistics for Type 3 GEE analysis|||||34.369|7.199|<0.0001
74047977|NCT04228445|147648609|OTHER||Percentage of Agreement|91.1|||||TWO_SIDED|||||||||Left Ureter||||
74047978|NCT04228445|147648609|OTHER||Percentage of Agreement|88.4|||||TWO_SIDED|||||||||Left Ureter||||
74047979|NCT04228445|147648609|OTHER||Percentage of Agreement|76.1|||||TWO_SIDED|||||||||Left Ureter||||
74047980|NCT04228445|147648609|OTHER||Percentage of Agreement|95.6|||||TWO_SIDED|||||||||Right Ureter||||
74047981|NCT04228445|147648609|OTHER||Percentage of Agreement|86.0|||||TWO_SIDED|||||||||Right Ureter||||
74047982|NCT04228445|147648609|OTHER||Percentage of Agreement|71.6|||||TWO_SIDED|||||||||Right Ureter||||
74047983|NCT04228445|147648610|SUPERIORITY||Odds Ratio (OR)|0.771||||0.4595|TWO_SIDED|95.0|0.388|1.534|||Score statistics for Type 3 GEE analysis|||||1.534|.388|0.4595
74047984|NCT04228445|147648611|SUPERIORITY||Odds Ratio (OR)|1.036||||0.922|TWO_SIDED|95.0|0.509|2.11|||Score statistics for Type 3 GEE analysis|||||2.110|.509|0.9220
74047985|NCT01316380|147648616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.036||0.0005||95.0|0.057|0.199||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.199|0.057|0.0005
74047986|NCT01316380|147648616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.088|0.23||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for the primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.230|0.088|<0.0001
74047987|NCT01316380|147648617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.037||0.001||95.0|0.049|0.194||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.194|0.049|0.001
74047988|NCT01316380|147648617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.037||0.0028||95.0|0.038|0.182||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.182|0.038|0.0028
74047989|NCT01316380|147648618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.042||0.1714||95.0|-0.025|0.14||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.140|-0.025|0.1714
74097413|NCT00790335|147743668|SUPERIORITY||Mean Difference (Net)|4.2|STANDARD_ERROR_OF_MEAN|2.39||0.08|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference in the change from baseline to 24 months between the two treatment arms.|||||0.08
74047990|NCT01316380|147648618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.042||0.0119||95.0|0.023|0.188||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.188|0.023|0.0119
74047991|NCT01316380|147648619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.034||0.0003||95.0|0.058|0.192||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.192|0.058|0.0003
74047992|NCT01316380|147648619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.082|0.216||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.216|0.082|<0.0001
74047993|NCT01316380|147648620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.039||0.1182||95.0|-0.016|0.138||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.138|-0.016|0.1182
74047994|NCT01316380|147648620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.039||0.0102||95.0|0.024|0.178||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.178|0.024|0.0102
74047995|NCT01316380|147648622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25||||0.2155||95.0|0.03|2.24||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.||2.24|0.03|0.2155
74047996|NCT01316380|147648622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.5071||95.0|0.43|5.44||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.||5.44|0.43|0.5071
74047997|NCT01316380|147648623|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.1217||95.0|0.29|1.16||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc).||1.16|0.29|0.1217
74047998|NCT01316380|147648623|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.8974||95.0|0.53|1.75||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc). The Hazard Ratio is still estimable from the Cox model.||1.75|0.53|0.8974
74047999|NCT01316380|147648624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.129||0.0872|TWO_SIDED|95.0|-0.032|0.476||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.476|-0.032|0.0872
74048000|NCT01316380|147648624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.033|STANDARD_ERROR_OF_MEAN|0.129||0.7995|TWO_SIDED|95.0|-0.287|0.221||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.221|-0.287|0.7995
74048001|NCT01316380|147648625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.097|STANDARD_ERROR_OF_MEAN|0.076||0.2038|TWO_SIDED|95.0|-0.053|0.247||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.||0.247|-0.053|0.2038
74048002|NCT01316380|147648625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.076||0.9104|TWO_SIDED|95.0|-0.158|0.141||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.141|-0.158|0.9104
74048003|NCT01316380|147648626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.068||0.0559|TWO_SIDED|95.0|-0.003|0.265||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.265|-0.003|0.0559
74048004|NCT01316380|147648626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.068||0.8795|TWO_SIDED|95.0|-0.144|0.123||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.123|-0.144|0.8795
74048005|NCT03793010|147648657|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-1.2|1.81||||||||1.81|-1.20|
74048006|NCT03793010|147648658|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.05|2.24||||||||2.24|-1.05|
74048007|NCT03793010|147648659|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|0.9||||||||0.9|-1.0|
74097414|NCT00790335|147743669|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.14||0.02|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.02
74048008|NCT02903966|147648676|OTHER||Least Square Mean Difference|-0.18|||||TWO_SIDED|95.0|-1.23|0.87|||||Analysis performed using a Mixed Models Repeated Measures (MMRM) model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and baseline value by visit interactions|||0.87|-1.23|
74048009|NCT02903966|147648677|OTHER||Least Square Mean Difference|0.02|||||TWO_SIDED|95.0|-1.18|1.22|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and baseline value by visit interactions|||1.22|-1.18|
74048010|NCT02903966|147648678|OTHER||Least Square Mean Difference|-0.05|||||TWO_SIDED|95.0|-4.11|4.02|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||4.02|-4.11|
74048011|NCT02903966|147648678|OTHER||Least Square Mean Difference|-3.17|||||TWO_SIDED|95.0|-5.99|-0.35|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||-0.35|-5.99|
74048012|NCT02903966|147648678|OTHER||Least Square Mean Difference|-1.69|||||TWO_SIDED|95.0|-6.26|2.88|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||2.88|-6.26|
74048013|NCT02903966|147648679|OTHER||Least Square Mean Difference|0.29|||||TWO_SIDED|95.0|-4.01|4.59|||||Day 57. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||4.59|-4.01|
74048014|NCT02903966|147648679|OTHER||Least Square Mean Difference|0.11|||||TWO_SIDED|95.0|-3.64|3.85|||||Day 71. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||3.85|-3.64|
74048015|NCT02903966|147648679|OTHER||Least Square Mean Difference|1.12|||||TWO_SIDED|95.0|-2.87|5.1|||||Day 85. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||5.10|-2.87|
74048016|NCT02903966|147648680|OTHER||Ratio|0.7|||||TWO_SIDED|95.0|0.27|1.8|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.80|0.27|
74048017|NCT02903966|147648680|OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.2|1.0|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.00|0.20|
74048018|NCT02903966|147648680|OTHER||Ratio|0.23|||||TWO_SIDED|95.0|0.09|0.62|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||0.62|0.09|
74048019|NCT02903966|147648681|OTHER||Ratio|0.49|||||TWO_SIDED|95.0|0.25|0.97|||||Day 57. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||0.97|0.25|
74048020|NCT02903966|147648681|OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.2|1.57|||||Day 71. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.57|0.20|
74048021|NCT02903966|147648681|OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.31|2.18|||||Day 85. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||2.18|0.31|
74048022|NCT02903966|147648682|OTHER||Least Square Mean Difference|0.01|||||TWO_SIDED|95.0|-2.05|2.07|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||2.07|-2.05|
74048023|NCT02903966|147648683|OTHER||Least Square Mean Difference|0.08|||||TWO_SIDED|95.0|-2.11|2.27|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||2.27|-2.11|
74048024|NCT02903966|147648684|OTHER||Least Square Mean Difference|-0.76|||||TWO_SIDED|95.0|-5.29|3.77|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||3.77|-5.29|
74048025|NCT02903966|147648685|OTHER||Least Square Mean Difference|-0.8|||||TWO_SIDED|95.0|-5.68|4.08|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||4.08|-5.68|
74048026|NCT02903966|147648690|OTHER||Least Square Mean Difference|-0.36|||||TWO_SIDED|95.0|-1.58|0.86|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||0.86|-1.58|
74048027|NCT02903966|147648690|OTHER||Least Square Mean Difference|-0.1|||||TWO_SIDED|95.0|-1.29|1.08|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.08|-1.29|
74048028|NCT02903966|147648690|OTHER||Least Square Mean Difference|-0.34|||||TWO_SIDED|95.0|-1.72|1.04|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.04|-1.72|
74048029|NCT02903966|147648691|OTHER||Least Square Mean Difference|-0.06|||||TWO_SIDED|95.0|-1.87|1.75|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.75|-1.87|
74097415|NCT00790335|147743670|SUPERIORITY||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.15||0.03|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.03
74097416|NCT00790335|147743671|SUPERIORITY||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.23||0.02|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.02
74097417|NCT00790335|147743672|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.23||0.05|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.05
74097418|NCT02699060|147743676|SUPERIORITY||Median Difference (Net)|-1.76|STANDARD_DEVIATION|0.8||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
73880895|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.07||||0.0231|TWO_SIDED|95.0|1.21|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||13.64|1.21|0.0231
74048030|NCT04423718|147648709|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.97||||0.0009|TWO_SIDED|95.0|-2.87|0.92||Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with next primary endpoint (HDq16-2q8) / within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq12-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.92|-2.87|0.0009
74048031|NCT04423718|147648709|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-1.14||||0.0011|TWO_SIDED|95.0|-2.97|0.69||Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with secondary endpoint (no IRF no SRF at W16)/within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq16-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.69|-2.97|0.0011
74048032|NCT04423718|147648710|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.86||||0.0002|TWO_SIDED|95.0|-2.57|0.84||EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested for EMA/PMDA after primary endpoint (HDq12-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with next primary endpoint (HDq16-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.84|-2.57|0.0002
74048033|NCT04423718|147648710|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.92|||<|0.0001|TWO_SIDED|95.0|-2.51|0.66||EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested after primary endpoint (HDq16-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with secondary endpoint test (no IRF no SRF at W16)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.66|-2.51|<0.0001
74048034|NCT04423718|147648711|SUPERIORITY|One sided test (alpha = 0.025) for superiority|Difference|11.733||||0.0002|TWO_SIDED|95.0|5.263|18.204||Strictly hierarchical testing procedure to adjust for multiplicity.|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|All HD - 2q8||18.204|5.263|0.0002
74048035|NCT04423718|147648712|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-1.748||||0.5704|TWO_SIDED|95.0|-7.784|4.287||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||4.287|-7.784|0.5704
74048036|NCT04423718|147648712|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-0.939||||0.7611|TWO_SIDED|95.0|-6.997|5.119||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||5.119|-6.997|0.7611
74048037|NCT04423718|147648713|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-0.182||||0.9554|TWO_SIDED|95.0|-6.565|6.2||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||6.200|-6.565|0.9554
74048038|NCT04423718|147648713|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-2.221||||0.4834|TWO_SIDED|95.0|-8.435|3.994||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||3.994|-8.435|0.4834
74097419|NCT04516759|147743682|SUPERIORITY||Risk Ratio (RR)|1.09||||0.1854|TWO_SIDED|95.0|0.9|1.32|||Chi-squared|Chi-squared test on the one-sided significance level of 2.5%||||1.32|0.9|0.1854
74048039|NCT04423718|147648714|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-1.22||||0.0009|TWO_SIDED|95.0|-1.94|-0.51||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CNV size and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-0.51|-1.94|0.0009
74097420|NCT04516759|147743683|OTHER|||||||0.0286||||||Baseline p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.0286
73880896|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.54||||0.0196|TWO_SIDED|95.0|1.27|16.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.15|1.27|0.0196
74048040|NCT04423718|147648714|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.48||||0.2076|TWO_SIDED|95.0|-1.22|0.27||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CNV size and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.27|-1.22|0.2076
74048041|NCT04423718|147648715|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.55||||0.0287|TWO_SIDED|95.0|-1.04|-0.06||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline total lesion area and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-0.06|-1.04|0.0287
74048042|NCT04423718|147648715|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.44||||0.087|TWO_SIDED|95.0|-0.94|0.06||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline total lesion area and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.06|-0.94|0.0870
74048043|NCT04423718|147648716|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|11.725||||0.0015|TWO_SIDED|95.0|4.527|18.923||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||18.923|4.527|0.0015
74048044|NCT04423718|147648716|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|7.451||||0.0458|TWO_SIDED|95.0|0.142|14.76||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||14.760|0.142|0.0458
74048045|NCT04423718|147648717|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-11.12||||0.0283|TWO_SIDED|95.0|-21.06|-1.18||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CST and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-1.18|-21.06|0.0283
74048046|NCT04423718|147648717|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-10.51||||0.0321|TWO_SIDED|95.0|-20.12|-0.9||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CST and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||-0.90|-20.12|0.0321
74048047|NCT04423718|147648718|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.72||||0.3817|TWO_SIDED|95.0|-2.35|0.9||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline NEI-VFQ-25 total score and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.90|-2.35|0.3817
74048048|NCT04423718|147648718|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.87||||0.307|TWO_SIDED|95.0|-2.55|0.8||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline NEI-VFQ-25 total score and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.80|-2.55|0.3070
74048049|NCT00425945|147648722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|95.0|-0.1|14.9||||||||14.9|-0.1|
74048050|NCT00425945|147648723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.4|||||TWO_SIDED|95.0|-2.1|10.8||||||||10.8|-2.1|
74048051|NCT00425945|147648724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-1.7|2.5||||||||2.5|-1.7|
74097421|NCT04516759|147743683|OTHER|||||||0.0786||||||Day 7 p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.0786
74048052|NCT00425945|147648725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.2|||||TWO_SIDED|95.0|-2.3|38.7||||||||38.7|-2.3|
74048053|NCT00425945|147648726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||||0.3|-0.1|
74048054|NCT00425945|147648727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||||0.1|-0.0|
74048055|NCT00425945|147648728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-6.8|0.5||||||||0.5|-6.8|
74048056|NCT00425945|147648729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.5|0.5||||||||0.5|-1.5|
74048057|NCT00425945|147648730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|0.0|0.4||||||||0.4|0.0|
74048058|NCT00425945|147648731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|0.1|2.4||||||||2.4|0.1|
74048059|NCT00425945|147648732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-4.4|2.3||||||||2.3|-4.4|
74097422|NCT04516759|147743683|OTHER|||||||0.2169||||||Day 14 p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.2169
74097423|NCT04516759|147743683|OTHER|||||||0.186||||||Day 21 p-value|Wilcoxon (Mann-Whitney)|one-sided significance level of 2.5%||||||0.1860
74097424|NCT04516759|147743683|OTHER|||||||0.2256||||||Study Drug Discontinuation (SDD) p-value|Wilcoxon (Mann-Whitney)|one-sided significance level of 2.5%||||||0.2256
74097425|NCT04516759|147743684|OTHER|||||||0.4006||||||Increase in Diabetic Medication needed equal or more than 3 days|Fisher Exact|||||||0.4006
74097426|NCT04516759|147743684|OTHER|||||||0.7482||||||Diabetic Medication is stable/reduced equal or more than 3 days|Fisher Exact|||||||0.7482
74097427|NCT04516759|147743684|OTHER|||||||0.6949||||||Increase in Diabetic Medication needed at any time during the study|Fisher Exact|||||||0.6949
74097428|NCT04516759|147743684|OTHER|||||||0.5521||||||Diabetic Medication is stable/reduced at any time during the study|Fisher Exact|||||||0.5521
74018650|NCT02531646|147589360|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test|||||||0.000
74048060|NCT00425945|147648733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|-0.9|2.5||||||||2.5|-0.9|
74048061|NCT00425945|147648734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
74048062|NCT00425945|147648735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.8|||||TWO_SIDED|95.0|-1.6|9.3||||||||9.3|-1.6|
74048063|NCT00425945|147648736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.4|0.8||||||||0.8|-3.4|
74048064|NCT01526928|147648796|OTHER||||||||||||||||||Since an MTD was never reached for any of the rociletinib FB or HBr formulations/doses, a 750 mg BID HBr starting dose was selected based on early efficacy data from Phase 1, and enrollment into Phase 2 was initiated at this dosage. As the Phase 1 efficacy data matured, the recommended dose was adjusted to 625 mg BID based on antitumor activity and safety evaluations.|||
74048065|NCT01108068|147648811|EQUIVALENCE|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype T-test was used to compare differences at baseline between affecteds and unaffecteds||||||0.0003|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Cortical area Z-score||||0.0003
74048066|NCT01108068|147648811|EQUIVALENCE|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype||||||0.001|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Periosteal circumference Z-score||||0.001
74048067|NCT00376675|147648816|SUPERIORITY_OR_OTHER|||||||0.317|||||||Wilcoxon rank sum test|||||||0.317
74097429|NCT04516759|147743685|OTHER|||||||0.5875|||||||Fisher Exact|||||||0.5875
74097430|NCT04516759|147743686|OTHER|||||||0.1129|||||||Fisher Exact|||||||0.1129
74097431|NCT04516759|147743687|SUPERIORITY|||||||0.1556|||||||Log Rank|||||||0.1556
74097432|NCT04516759|147743688|OTHER||Risk Ratio (RR)|0.41||||0.0903|TWO_SIDED|95.0|0.13|1.26|||Fisher Exact|The p-value is assessed by means of an Fisher's exact test on the one-sided significance level of 2.5%||||1.26|0.13|0.0903
74018651|NCT02531646|147589361|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test|||||||0.000
74018652|NCT02531646|147589362|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
74018653|NCT02531646|147589363|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
74018654|NCT02531646|147589364|SUPERIORITY_OR_OTHER|||||||0.007||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.007
74018655|NCT02531646|147589366|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
74018656|NCT02851173|147589377|OTHER|||||||0.79|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. CU group.||||0.79
74018657|NCT02851173|147589377|OTHER|||||||0.87|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. MCI group.||||0.87
74018658|NCT02851173|147589377|OTHER|||||||0.16|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. CU group. 3 outliers removed, whose scores were outside 1.5 times the interquartile range.||||0.16
74018659|NCT02851173|147589378|OTHER|||||||0.22|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left middle frontal gyrus 1.||||0.22
74018660|NCT02851173|147589378|OTHER|||||||0.69|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left medial frontal/superior frontal gyrus.||||0.69
74018661|NCT02851173|147589378|OTHER|||||||0.25|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right superior parietal lobule.||||0.25
74018662|NCT02851173|147589378|OTHER|||||||0.86|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left inferior parietal lobule.||||0.86
74018663|NCT02851173|147589378|OTHER|||||||0.28|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left middle frontal gyrus 2.||||0.28
74018664|NCT02851173|147589378|OTHER|||||||0.12|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right superior frontal gyrus.||||0.12
74018665|NCT02851173|147589378|OTHER|||||||0.26|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right middle frontal gyrus.||||0.26
74018666|NCT02851173|147589378|OTHER|||||||0.83|||||||ANOVA|||The contract of interest was the Time x Treatment Group interaction. Right inferior frontal gyrus.||||0.83
74018667|NCT02851173|147589378|OTHER|||||||0.55|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left middle frontal gyrus 1.||||0.55
74018668|NCT02851173|147589378|OTHER|||||||0.76|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left medial frontal/superior frontal gyrus.||||0.76
74018669|NCT02851173|147589378|OTHER|||||||0.38|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right superior parietal lobule.||||0.38
74018670|NCT02851173|147589378|OTHER|||||||0.93|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left inferior parietal lobule.||||0.93
74018671|NCT02851173|147589378|OTHER|||||||0.41|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left middle frontal gyrus 2.||||0.41
74097433|NCT04516759|147743689|OTHER|||||||0.6144|||||||Fisher Exact|One-sided significance level of 2.5%||||||0.6144
74097434|NCT04516759|147743690|OTHER|||||||0.0105|||||||Fisher Exact|one-sided significance level of 2.5%||||||0.0105
74097435|NCT04516759|147743691|OTHER|||||||0.062|||||||Fisher Exact|one-sided significance level of 2.5%||||||0.062
74097436|NCT04916444|147743737|SUPERIORITY|||||||0.691|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the TWSTRS scores.||||0.691
74097437|NCT04916444|147743738|SUPERIORITY|||||||0.816|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the BDI scores.||||0.816
74097438|NCT04916444|147743739|SUPERIORITY|||||||0.167|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the time to complete the TMT-A task.||||0.167
74018672|NCT02851173|147589378|OTHER|||||||0.06|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right superior frontal gyrus.||||0.06
74018673|NCT02851173|147589378|OTHER|||||||0.18|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right middle frontal gyrus.||||0.18
74018674|NCT02851173|147589378|OTHER|||||||0.84|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right inferior frontal gyrus.||||0.84
74018675|NCT02851173|147589379|OTHER|||||||0.53|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction.||||0.53
74018676|NCT02851173|147589379|OTHER|||||||0.74|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy).||||0.74
74018677|NCT02851173|147589380|OTHER|||||||0.72|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction.||||0.72
74018678|NCT02851173|147589380|OTHER|||||||0.97|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy).||||0.97
74018679|NCT02363478|147589407|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of contractions, resting LES pressure and IRP between baseline and week 4.||||||<0.05
74018680|NCT02363478|147589410|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of heartburn, regurgitation, chest pain and dysphagia between baseline and week 4.||||||0.05
74018681|NCT02554929|147589415|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.42||0.002|TWO_SIDED|95.0|-0.91|0.74||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SAD.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||0.74|-0.91|0.002
74018682|NCT02554929|147589415|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.62||0.002|TWO_SIDED|95.0|-0.95|1.48||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SM.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||1.48|-0.95|0.002
74018683|NCT02554929|147589418|SUPERIORITY||Mean Difference (Final Values)|1.89|STANDARD_ERROR_OF_MEAN|3.14||0.002|TWO_SIDED|95.0|-4.28|8.08||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||The estimated value of the estimation parameter corresponds to the difference between change in CGAS scores for participants in the CBT arm, in comparison to those in the socialization arm, from pre-treatment to 6-month follow-up.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||8.08|-4.28|0.002
74018684|NCT01916980|147589421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in least squares (LS) mean for the Desloratadine: Eczema/Dermatitis group||||<0.001
74018685|NCT01916980|147589421|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in LS mean for the Desloratadine: Dermal Pruritus group||||<0.001
74018686|NCT02324270|147589427|EQUIVALENCE|If the 90% CI for the ratio of mean changes between test and reference products was contained within the interval, \[0.80,1.25\], then the products were considered to be equivalent.|Ratio|1.01|||||TWO_SIDED|90.0|0.94|1.08||||||||1.08|0.94|
74018687|NCT02324270|147589428|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
74018688|NCT02324270|147589428|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
73880897|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7703|TWO_SIDED|95.0|0.42|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||3.24|0.42|0.7703
73880898|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.83||||0.0222|TWO_SIDED|95.0|1.21|12.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.12|1.21|0.0222
73880899|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0668|TWO_SIDED|95.0|0.93|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.21|0.93|0.0668
73880900|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7533|TWO_SIDED|95.0|0.43|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.22|0.43|0.7533
74018689|NCT03968419|147589477|OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-25.56|21.23||||||Difference in MPR rate||21.23|-25.56|
74018690|NCT01641939|147589492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.8589|TWO_SIDED|95.0|0.87|1.6||One sided p-value with correction for interim treatment selection due to adaptive seamless phase design.|Log Rank|Log-Rank test, inverse normal combination test.||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% Confidence Interval (CI) for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||1.60|0.87|0.8589
74018691|NCT01641939|147589493|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.32|2.03||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||2.03|0.32|
74018692|NCT01641939|147589493|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01|||||TWO_SIDED|95.0|0.82|4.92||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||4.92|0.82|
74018693|NCT01641939|147589493|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.23|0.96||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Trastuzumab Emtansine 3.6 mg||0.96|0.23|
74018694|NCT01641939|147589495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.308|TWO_SIDED|95.0|0.89|1.43|||Log Rank|||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy||1.43|0.89|0.308
74018695|NCT00167245|147589528|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
74018696|NCT00167245|147589529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||Generalized Estimating Equations|||||||0.45
74018697|NCT00167245|147589530|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.4|TWO_SIDED|95.0|-2.1|5.2|||t-test, 2 sided|||||5.2|-2.1|0.4
74018698|NCT00700180|147589555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8127|TWO_SIDED|95.0|0.63|1.8||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||bFGF (high versus low)||1.80|0.63|0.8127
74018699|NCT00700180|147589555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0285|TWO_SIDED|95.0|1.06|3.08||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||E-selectin (high versus low)||3.08|1.06|0.0285
74018700|NCT00700180|147589555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7478|TWO_SIDED|95.0|0.64|1.85||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||ICAM (high versus low)||1.85|0.64|0.7478
74018701|NCT00700180|147589555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6761|TWO_SIDED|95.0|0.58|2.33||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||PlGF (high versus low)||2.33|0.58|0.6761
74018702|NCT00700180|147589555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4601|TWO_SIDED|95.0|0.72|2.09||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGF A (high versus low)||2.09|0.72|0.4601
74018703|NCT00700180|147589555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.3193|TWO_SIDED|95.0|0.46|1.29||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-1 (high versus low)||1.29|0.46|0.3193
74018704|NCT00700180|147589555|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.1758|TWO_SIDED|95.0|0.85|2.45||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-2 (high versus low)||2.45|0.85|0.1758
74018705|NCT00700180|147589557|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9454|TWO_SIDED|95.0|0.78|1.31|||Log Rank|||||1.31|0.78|0.9454
74018706|NCT00700180|147589558|SUPERIORITY_OR_OTHER||Difference in Responses Rates|9.34||||0.1737|TWO_SIDED|95.0|-2.4|21.0|||Cochran-Mantel-Haenszel||Approximate 95% Confidence Interval (CI) for difference of two rates using Hauck-Anderson method.|||21.0|-2.4|0.1737
74018707|NCT00700180|147589559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.75||||0.6148|TWO_SIDED|95.0|-8.2|11.7|||Cochran-Mantel-Haenszel||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||11.7|-8.2|0.6148
74018708|NCT00700180|147589561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.7587|TWO_SIDED|95.0|0.68|1.69|||Log Rank|||||1.69|0.68|0.7587
74097439|NCT04916444|147743740|SUPERIORITY|||||||0.507|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the time to complete the TMT-A task.||||0.507
74097440|NCT04916444|147743741|SUPERIORITY|||||||0.056|||||||ANOVA|Two-way repeated measures ANOVA||||||0.056
74048068|NCT00062647|147648828|NON_INFERIORITY_OR_EQUIVALENCE|No margin was justified owing to the exploratory nature of the investigation.|Risk Difference (RD)|1.0||||||95.0|-35.5|31.9|||the difference in the 2 eradication rate|Statistical testing was limited to interval estimation (95% CI) of the difference in the 2 eradication rates using the method of Agresti and Caffo.||||31.9|-35.5|
74048069|NCT05083949|147648850|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|99.57|STANDARD_DEVIATION|5.23||0.7792|TWO_SIDED|90.0|97.03|102.19|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.19|97.03|0.7792
74048070|NCT05083949|147648851|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.36|STANDARD_DEVIATION|10.18||0.6493|TWO_SIDED|90.0|96.39|106.59|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.59|96.39|0.6493
74048071|NCT05083949|147648852|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.63|STANDARD_DEVIATION|7.65||0.471|TWO_SIDED|90.0|97.85|105.55|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of the was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.55|97.85|0.4710
74048072|NCT05083949|147648853|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|98.11|STANDARD_DEVIATION|8.14||0.4251|TWO_SIDED|90.0|94.24|102.15|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.15|94.24|0.4251
74048073|NCT05083949|147648854|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|99.49|STANDARD_DEVIATION|5.25||0.7379|TWO_SIDED|90.0|96.93|102.11|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.11|96.93|0.7379
74097441|NCT04916444|147743742|SUPERIORITY|||||||0.646|||||||ANOVA|Two-way repeated measures ANOVA||||||0.646
74097442|NCT02695537|147743753|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
74048074|NCT05083949|147648855|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.24|STANDARD_DEVIATION|7.82||0.5895|TWO_SIDED|90.0|97.4|105.24|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.24|97.40|0.5895
74048075|NCT02996500|147648864|SUPERIORITY||Mean Difference (Net)|-7.83||||0.005|TWO_SIDED|95.0|-13.73|-1.97|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-1.97|-13.73|0.0050
74048076|NCT02996500|147648864|SUPERIORITY||Mean Difference (Net)|-8.96|||<|0.001|TWO_SIDED|95.0|-14.37|-3.66|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-3.66|-14.37|<0.001
74048077|NCT02996500|147648864|SUPERIORITY||Median Difference (Net)|-10.89|||<|0.001|TWO_SIDED|95.0|-16.36|-5.63|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-5.63|-16.36|<0.001
74048078|NCT02996500|147648864|SUPERIORITY||Mean Difference (Net)|-11.29|||<|0.001|TWO_SIDED|95.0|-16.62|-5.92|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-5.92|-16.62|<0.001
74048079|NCT00835276|147648910|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|87.96||||||90.0|80.15|96.53|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.|||96.53|80.15|
74097443|NCT02695537|147743754|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
74097444|NCT04558918|147743796|SUPERIORITY||Odds Ratio (OR)|338.25|||<|0.0001|TWO_SIDED|95.0|25.07|4564.14||two sided unadjusted p-value|Regression, Logistic|Logistic regression model using Firth||||4564.14|25.07|<0.0001
74097445|NCT04558918|147743796|SUPERIORITY||Difference in marginal proportion|80.2|||||TWO_SIDED|95.0|71.2|87.6||||||||87.6|71.2|
74048080|NCT00835276|147648911|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.15|98.26|||||To establish bioequivalence, the mean values for the test product differ by no more that 20% from the repective mean values for the reference listed product.|||98.26|85.15|
74048081|NCT00835276|147648912|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.32|98.07|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.|||98.07|85.32|
74048082|NCT02332876|147648932|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74048083|NCT02614261|147648949|SUPERIORITY||LSMean Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.92|-1.26|||Mixed Models Analysis|||||-1.26|-2.92|<.001
74048084|NCT02614261|147648949|SUPERIORITY||LSMean Difference|-1.88|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.71|-1.05|||Mixed Models Analysis|||||-1.05|-2.71|<.001
74048085|NCT02614261|147648950|SUPERIORITY||Odds Ratio (OR)|1.623||||0.004|TWO_SIDED|95.0|1.167|2.256|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%,||2.256|1.167|.004
74048086|NCT02614261|147648950|SUPERIORITY||Odds Ratio (OR)|1.788|||<|0.001|TWO_SIDED|95.0|1.291|2.474|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%||2.474|1.291|<.001
74048087|NCT02614261|147648950|SUPERIORITY||Odds Ratio (OR)|1.498||||0.102|TWO_SIDED|95.0|0.923|2.43|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%||2.430|0.923|.102
74048088|NCT02614261|147648950|SUPERIORITY||Odds Ratio (OR)|1.819||||0.011|TWO_SIDED|95.0|1.146|2.888|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%||2.888|1.146|.011
74048089|NCT02614261|147648950|SUPERIORITY||Odds Ratio (OR)|0.761||||0.729|TWO_SIDED|95.0|0.163|3.563|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%||3.563|0.163|0.729
74097446|NCT04558918|147743797|SUPERIORITY||Odds Ratio (OR)|495.74|||<|0.0001|TWO_SIDED|95.0|24.41|10066.53||two sided unadjusted p-value|Regression, Logistic|Logistic regression model using Firth||||10066.53|24.41|<0.0001
74097447|NCT04558918|147743797|SUPERIORITY||Diff. in marginal proportion|67.0|||||TWO_SIDED|95.0|56.4|76.9||||||||76.9|56.4|
74097448|NCT04558918|147743800|OTHER||Adjusted mean difference|-0.01|||||TWO_SIDED|95.0|-0.53|0.51||||||||0.51|-0.53|
74097449|NCT04558918|147743801|OTHER||Adjusted mean difference|-1.17|||||TWO_SIDED|95.0|-4.01|1.68||||||||1.68|-4.01|
74048090|NCT02614261|147648950|SUPERIORITY||Odds Ratio (OR)|1.897||||0.276|TWO_SIDED|95.0|0.6|5.998|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%||5.998|0.600|.276
74048091|NCT02614261|147648951|SUPERIORITY||LSMean Difference|5.06|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|2.12|7.99|||Mixed Models Analysis|||||7.99|2.12|<.001
74048092|NCT02614261|147648951|SUPERIORITY||LSMean Difference|6.29|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|3.03|9.55|||Mixed Models Analysis|||||9.55|3.03|<.001
74048093|NCT02614261|147648952|SUPERIORITY||LSMean Difference|-2.51|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-3.27|-1.76|||Mixed Models Analysis|||||-1.76|-3.27|<.001
74048094|NCT02614261|147648952|SUPERIORITY||LSMean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.77|-1.26|||Mixed Models Analysis|||||-1.26|-2.77|<.001
74048095|NCT02614261|147648953|SUPERIORITY||LSMean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.181|TWO_SIDED|95.0|-0.34|0.06|||Mixed Models Analysis|||||0.06|-0.34|.181
74048096|NCT02614261|147648953|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.48|-0.08|||Mixed Models Analysis|||||-0.08|-0.48|.006
74048097|NCT02614261|147648954|SUPERIORITY||LSMean Difference|-22.71|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-31.74|-13.69|||Mixed Models Analysis|||||-13.69|-31.74|<.001
74048098|NCT02614261|147648954|SUPERIORITY||LSMean Difference|-18.09|STANDARD_ERROR_OF_MEAN|4.58|<|0.001|TWO_SIDED|95.0|-27.09|-9.09|||Mixed Models Analysis|||||-9.09|-27.09|<.001
74048099|NCT02614261|147648955|SUPERIORITY||LSMean Difference|-8.74|STANDARD_ERROR_OF_MEAN|3.9||0.025|TWO_SIDED|95.0|-16.39|-1.08|||ANCOVA|||||-1.08|-16.39|.025
74048100|NCT02614261|147648955|SUPERIORITY||LSMean Difference|-5.49|STANDARD_ERROR_OF_MEAN|3.88||0.157|TWO_SIDED|95.0|-13.1|2.12|||ANCOVA|||||2.12|-13.10|.157
74048101|NCT02614261|147648956|SUPERIORITY|||||||0.263|||||||Cochran-Mantel-Haenszel|||||||.263
74048102|NCT02614261|147648956|SUPERIORITY|||||||0.29|||||||Cochran-Mantel-Haenszel|||||||.290
74048103|NCT02574520|147649007|SUPERIORITY|Primary|Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.24||0.124|TWO_SIDED|95.0|-0.84|0.1|||ANOVA|Mixed model with repeated measures (MMRM) for scheduled pain measurements was estimated with time as a repeating factor within subject.|Least squares mean from the MMRM described in the Statistical Test of Hypothesis.|Pain Intensity on Movement 0-48 hr||0.10|-0.84|0.124
74048104|NCT01868594|147649108|SUPERIORITY|||||||0.019||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.019
74048105|NCT01868594|147649109|SUPERIORITY|||||||0.0432||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0432
74048106|NCT01868594|147649110|SUPERIORITY|||||||0.7344||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.7344
74048107|NCT01868594|147649111|SUPERIORITY|||||||0.278||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.2780
74048108|NCT01868594|147649111|SUPERIORITY|||||||0.8114||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.8114
74048109|NCT01868594|147649111|SUPERIORITY|||||||0.1619||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.1619
74048110|NCT01868594|147649111|SUPERIORITY|||||||0.0764||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.0764
74048111|NCT01868594|147649112|SUPERIORITY|||||||0.3107||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of basal insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.3107
74048112|NCT01868594|147649112|SUPERIORITY|||||||0.5236||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of prandial insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.5236
74048113|NCT01868594|147649112|SUPERIORITY|||||||0.3847||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total daily dose insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.3847
74048114|NCT01868594|147649113|SUPERIORITY|||||||0.6716|||||||t-test, 2 sided|||||||0.6716
74048115|NCT01868594|147649114|SUPERIORITY|||||||0.2484||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total Treatment Satisfaction score at Week 36 endpoint between Subetta and Placebo treatment groups.||||0.2484
74048116|NCT01868594|147649114|SUPERIORITY|||||||0.761||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hyperglycaemia question at Week 36 endpoint between Subetta and Placebo treatment groups."||||0.7610
74048117|NCT01868594|147649114|SUPERIORITY|||||||0.3714||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hypoglycemia question at Week 36 endpoint between Subetta and Placebo treatment groups."||||0.3714
74048118|NCT04964557|147649118|SUPERIORITY||Mean Difference (Final Values)|-62.3|||<|0.001|TWO_SIDED|95.0|-68.0|-56.6|||ANCOVA|||||-56.6|-68|<0.001
74048119|NCT04964557|147649119|SUPERIORITY||Mean Difference (Final Values)|-76.7|||<|0.001|TWO_SIDED|95.0|-81.7|-71.7|||ANCOVA|||||-71.7|-81.7|<0.001
74097450|NCT04558918|147743802|SUPERIORITY||Odds Ratio (OR)|108.41|||<|0.0001|TWO_SIDED|95.0|17.25|681.24||two sided unadjusted p-value|Conditional logistic regression|||||681.24|17.25|<0.0001
74097451|NCT04558918|147743802|SUPERIORITY||Diff. in marginal proportion|68.9|||||TWO_SIDED|95.0|51.4|83.9||||||logistic regression model||83.9|51.4|
74097452|NCT04558918|147743803|SUPERIORITY||Adjusted mean diff.|3.66|||<|0.0001|TWO_SIDED|95.0|3.2|4.12||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||4.12|3.20|<0.0001
74097453|NCT04558918|147743804|SUPERIORITY||Mean Difference (Net)|8.29|||<|0.0001|TWO_SIDED|95.0|5.28|11.29||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||11.29|5.28|<0.0001
74097454|NCT04558918|147743805|SUPERIORITY||Mean Difference (Net)|-116.15|||<|0.0001|TWO_SIDED|95.0|-132.04|-100.26||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||-100.26|-132.04|<0.0001
74097455|NCT04558918|147743806|SUPERIORITY||Geometric mean ratio|0.99||||0.8361|TWO_SIDED|95.0|0.89|1.1||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||1.10|0.89|0.8361
73880901|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3325|TWO_SIDED|95.0|0.59|4.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.73|0.59|0.3325
73880902|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0899|TWO_SIDED|95.0|0.86|8.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.57|0.86|0.0899
74048120|NCT04363944|147649157|EQUIVALENCE|A paired-t test comparing performance of vertical bowl transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||<|0.001||||||Comparing the change in performing a vertical bowl transfer, the calculated p-value for this activity was \<.001|t-test, 2 sided|||mRehab task vertical bowl transfer- moving the bowl vertically up and down||||<0.001
74097456|NCT04558918|147743807|SUPERIORITY||Rate ratio|0.1||||0.01183|TWO_SIDED|95.0|0.02|0.61||two sided unadjusted p-value|Negative binomial model|||||0.61|0.02|0.01183
74097457|NCT04558918|147743807|SUPERIORITY||Rate difference|-0.6|||||TWO_SIDED|95.0|-1.24|0.04||||||||0.04|-1.24|
74097458|NCT04558918|147743808|SUPERIORITY||rate difference|0.03||||0.31731|TWO_SIDED|95.0|-0.03|0.1||two sided unadjusted p-value|Poisson model|||||0.10|-0.03|0.31731
74097459|NCT04558918|147743809|OTHER||Adjusted mean difference|1.69|||||TWO_SIDED|95.0|-16.86|20.23||||||||20.23|-16.86|
74097460|NCT04558918|147743810|OTHER||Geometric mean ratio|1.12|||||TWO_SIDED|95.0|0.97|1.3||||||||1.30|0.97|
74097461|NCT02737748|147743828|OTHER|||||||0.2217|||||||Cochran-Mantel-Haenszel|||||||0.2217
74097462|NCT02737748|147743829|OTHER|||||||0.0324|||||||Cochran-Mantel-Haenszel|||||||0.0324
74097463|NCT02737748|147743830|OTHER|||||||0.3975|||||||Log Rank|||||||0.3975
74097464|NCT01292226|147743872|SUPERIORITY_OR_OTHER|||||||0.4505||||||Free MPA, time 0 \[trough\]|ANOVA|Analysis of variance (ANOVA)||||||0.4505
74097465|NCT01292226|147743872|SUPERIORITY_OR_OTHER|||||||0.7322||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.7322
74097466|NCT01292226|147743872|SUPERIORITY_OR_OTHER|||||||0.6798||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.6798
74097467|NCT01292226|147743872|SUPERIORITY_OR_OTHER|||||||0.541||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.5410
74097468|NCT01292226|147743873|SUPERIORITY_OR_OTHER|||||||0.3892||||||Free MPA, time 0 \[trough\]|ANOVA|||||||0.3892
74097469|NCT01292226|147743873|SUPERIORITY_OR_OTHER|||||||0.6564||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.6564
74097470|NCT01292226|147743873|SUPERIORITY_OR_OTHER|||||||0.7772||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.7772
74097471|NCT01292226|147743873|SUPERIORITY_OR_OTHER|||||||0.0958||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.0958
74048121|NCT04363944|147649157|EQUIVALENCE|A paired-t test comparing performance of moving the bowl horizontally at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.001||||||Comparing the change in performing a horizontal bowl transfer, the calculated p-value for this activity was .001|t-test, 2 sided|||mRehab task horizontal bowl transfer- moving the bowl horizontally||||=.001
74048122|NCT04363944|147649157|EQUIVALENCE|A paired-t test comparing performance of the vertical mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.003||||||Comparing the change in performing a vertical mug transfer, the calculated p-value for this activity was .003|t-test, 2 sided|||mRehab task vertical mug transfer- moving the mug vertically up and down||||=.003
74097472|NCT01292226|147743874|SUPERIORITY_OR_OTHER|||||||0.5796||||||Time 0 \[trough\]|ANOVA|||||||0.5796
74097473|NCT01292226|147743874|SUPERIORITY_OR_OTHER|||||||0.3428||||||Time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3428
74097474|NCT01292226|147743875|SUPERIORITY_OR_OTHER|||||||0.9372||||||Free MPA, time 0 \[trough\]|ANOVA|||||||0.9372
74097475|NCT01292226|147743875|SUPERIORITY_OR_OTHER|||||||0.9904||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.9904
74097476|NCT01292226|147743875|SUPERIORITY_OR_OTHER|||||||0.3658||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3658
74097477|NCT01292226|147743875|SUPERIORITY_OR_OTHER|||||||0.2987||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.2987
74097478|NCT01292226|147743876|SUPERIORITY_OR_OTHER|||||||0.7455||||||time 0 \[trough\]|ANOVA|||||||0.7455
74097479|NCT01292226|147743876|SUPERIORITY_OR_OTHER|||||||0.8504||||||Time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.8504
74097480|NCT01292226|147743877|SUPERIORITY_OR_OTHER|||||||0.6847||||||IMPDH I, time 0 \[trough\]|ANOVA|||||||0.6847
74097481|NCT01292226|147743877|SUPERIORITY_OR_OTHER|||||||0.3184||||||IMPDH I, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3184
73880903|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0642|TWO_SIDED|95.0|0.93|11.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.79|0.93|0.0642
74048123|NCT04363944|147649157|EQUIVALENCE|A paired-t test comparing performance of the horizontal mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.009||||||Comparing the change in performing a horizontal mug transfer, the calculated p-value for this activity was .009|t-test, 2 sided|||mRehab task horizontal mug transfer- moving the mug horizontally||||=.009
74048124|NCT04363944|147649157|EQUIVALENCE|A paired-t test comparing performance of the simulated sip at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.933|||||||t-test, 2 sided|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.||mRehab task simulate sip- bring mug within one inch of mouth as if taking a drink||||=.933
74048125|NCT04363944|147649157|EQUIVALENCE|A paired-t test comparing performance of entering a phone number at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.136|||||||t-test, 2 sided|||mRehab task enter phone number||||=.136
74048126|NCT04363944|147649157|EQUIVALENCE|A paired-t test comparing performance of the quick tap at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.005|||||||t-test, 2 sided|||mRehab task quick tap- tapping a moving object on the phone screen||||=.005
74048127|NCT04363944|147649158|EQUIVALENCE|Paired t-tests comparing performance at the first session of in-home training to the last session of in-home training were conducted.|||||=|0.228|||||||t-test, 2 sided|||mRehab task vertical bowl transfer- moving bowl vertically up and down||||=.228
74048128|NCT04363944|147649158|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.||||||0.196|||||||t-test, 2 sided|||mRehab task horizontal bowl- bowl moved horizontally||||.196
74048129|NCT04363944|147649158|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.024|||||||t-test, 2 sided|||mRehab task Vertical Mug- Mug moved vertically and then placed on counter||||=.024
73880904|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5964|TWO_SIDED|95.0|0.46|3.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.89|0.46|0.5964
74048130|NCT04363944|147649158|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.038|||||||t-test, 2 sided|||mRehab task horizontal mug transfer- moving the mug horizontally||||=.038
74048131|NCT04363944|147649158|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.306||||||calculated p-value greater than .05|t-test, 2 sided|||mRehab task simulate sip||||=.306
74048132|NCT04363944|147649159|EQUIVALENCE|The average of the WMFT from testing sessions pre intervention (week 1 and approximately week 2) was compared to the WMFT immediately following mRehab home intervention (week 8) using a two tailed paired t-test.|||||=|0.017||||||calculated p-value .017|t-test, 2 sided|||||||=.017
74048133|NCT04363944|147649160|EQUIVALENCE|Test, the scores from the first and second in-laboratory visits were averaged to account for variability in the performance of individuals with stroke. This averaged preintervention score was compared with the third in-laboratory visit to assess the immediate change in performance following use of mRehab.|||||=|0.019|||||||t-test, 2 sided|||Compared pre and post intervention data for participants using mRehab for a 6 week home program.||||=.019
73880905|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.43||||0.0224|TWO_SIDED|95.0|1.23|15.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||15.91|1.23|0.0224
74048134|NCT03649815|147649171|OTHER|||||||0.067|||||||Paired Sample T-Test|||||||0.067
74048135|NCT03649815|147649171|OTHER|||||||0.071||||||Controlled for gender, age, and baseline symptomatology|Paired Sample T-Test|||||||0.071
74048136|NCT03649815|147649172|OTHER|||||||0.047|||||||Paired Sample T-Test|||||||0.047
74048137|NCT03649815|147649172|OTHER|||||||0.036||||||Controlled for gender, age and baseline symptomatology|Paired Sample T-Test|||||||0.036
74048138|NCT03649815|147649173|OTHER|||||||0.032|||||||Paired Sample T-Test|||||||0.032
74048139|NCT03649815|147649173|OTHER|||||||0.006||||||Controlled for gender, age and baseline symptomatology|Paired Sample T-Test|||||||0.006
74048140|NCT03258593|147649178|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|67.5||||0.202|TWO_SIDED|95.0|25.0|75.0||Unadjusted p-value|Wilcoxon Rank sum test|||||75|25|0.202
74018709|NCT00700180|147589563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.312|TWO_SIDED|95.0|0.87|1.53|||Log Rank|||||1.53|0.87|0.3120
74018710|NCT03569202|147589566|SUPERIORITY||Mean Difference (Final Values)|1.8837||||0.662|TWO_SIDED|95.0|-6.7081|10.4756||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||10.4756|-6.7081|0.662
74018711|NCT03569202|147589566|OTHER||Mean Difference (Final Values)|-24.6445|||<|0.0001|TWO_SIDED|95.0|-30.7199|-18.5692||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-18.5692|-30.7199|<0.0001
74018712|NCT03569202|147589566|OTHER||Mean Difference (Final Values)|-26.5283|||<|0.0001|TWO_SIDED|95.0|-32.6036|-20.4529||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-20.4529|-32.6036|<0.0001
74018713|NCT03569202|147589567|OTHER||Mean Difference (Final Values)|-2.9808||||0.575|TWO_SIDED|95.0|-13.6005|7.639||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||7.6390|-13.6005|0.575
74018714|NCT03569202|147589567|OTHER||Mean Difference (Final Values)|-4.75||||0.2098|TWO_SIDED|95.0|-12.2593|2.7593||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||2.7593|-12.2593|0.2098
74048141|NCT03258593|147649178|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|114.0||||0.667|TWO_SIDED|95.0|67.9|160.3||Unadjusted p-value|Wilcoxon Rank sum test|||||160.3|67.9|0.667
74048142|NCT03258593|147649178|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|44.1||||0.463|TWO_SIDED|95.0|25.0|75.0|||Wilcoxon Rank sum test|||||75|25|0.463
74048143|NCT03258593|147649180|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|-17.75||||0.863|TWO_SIDED|95.0|-211.6|170.3|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||170.3|-211.6|0.863
74048144|NCT03258593|147649180|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|114.1||||0.666|TWO_SIDED|95.0|67.9|160.3|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||160.3|67.9|0.666
74048145|NCT03258593|147649180|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|21.3||||0.949|TWO_SIDED|95.0|-203.9|269.9|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||269.9|-203.9|0.949
74048146|NCT03258593|147649182|OTHER|Other: median difference|Median Difference (Net)|4.34|||<|0.001|TWO_SIDED|95.0|1.7|38.0||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interferon Gamma (IFN-γ) at 3 weeks compared to their respective baseline values.||38.0|1.7|<0.001
74048147|NCT03258593|147649182|OTHER|Other: median difference|Median Difference (Net)|3.29|||<|0.001|TWO_SIDED|95.0|1.5|11.25||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interferon Gamma (IFN-γ) at 5 weeks compared to their respective baseline values.||11.25|1.5|<0.001
74048148|NCT03258593|147649182|OTHER|Other: median difference|Median Difference (Net)|0.4|||<|0.05|TWO_SIDED|95.0|0.1|0.7||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Tumor Necrosis Factor Alpha (TNF-α) at 3 weeks compared to their respective baseline values.||0.7|0.1|<0.05
74048149|NCT03258593|147649182|OTHER|Other: median difference|Median Difference (Net)|0.24||||0.052|TWO_SIDED|95.0|-0.01|0.96||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Tumor Necrosis Factor Alpha (TNF-α ) at 5 weeks compared to their respective baseline values.||0.96|-0.01|0.052
74048150|NCT03258593|147649182|OTHER|Other: median difference|Median Difference (Net)|0.39||||0.055|TWO_SIDED|95.0|-0.03|4.61||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 6 (IL-6) at 3 weeks as compared to their respective baseline values.||4.61|-0.03|0.055
74048151|NCT03258593|147649182|OTHER|Other: median difference|Median Difference (Net)|0.54||||0.06|TWO_SIDED|95.0|-0.06|1.96|||Paired samples Wilcoxon rank sum test|Hochberg adjustment may be used.||Interleukin 6 (IL-6) at 5 weeks as compared to their respective baseline values.||1.96|-0.06|0.06
74097482|NCT01292226|147743877|SUPERIORITY_OR_OTHER|||||||0.3862||||||IMPDH II, time 0 \[trough\]|ANOVA|||||||0.3862
74097483|NCT01292226|147743877|SUPERIORITY_OR_OTHER|||||||0.904||||||IMPDH II, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.9040
74048152|NCT03258593|147649182|OTHER|Other: median difference|Median Difference (Net)|0.73||||0.42|TWO_SIDED|95.0|-1.63|1.62||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 8 (IL-8) at 3 weeks as compared to their respective baseline values.||1.62|-1.63|0.420
74097484|NCT01292226|147743877|SUPERIORITY_OR_OTHER|||||||0.0907||||||IMPDH activity, time 0 \[trough\]|ANOVA|||||||0.0907
74048153|NCT03258593|147649182|OTHER|Other: median difference|Median Difference (Net)|-0.39||||0.733|TWO_SIDED|95.0|-1.315|1.31||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 8 (IL-8) at 5 weeks as compared to their respective baseline values.||1.31|-1.315|0.733
74048154|NCT03258593|147649182|OTHER|Other: median difference|Median Difference (Net)|0.12||||0.01|TWO_SIDED|95.0|0.04|0.21||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 10 (IL-10) at 3 weeks as compared to their respective baseline values.||0.21|0.04|0.010
74048155|NCT03258593|147649182|OTHER|Other: median difference|Median Difference (Net)|0.1||||0.014|TWO_SIDED|95.0|0.04|0.4||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 10 (IL-10) at 5 weeks as compared to their respective baseline values.||0.40|0.04|0.014
74048156|NCT03258593|147649184|OTHER|One curve estimated in this cohort. Not compared to any other curves.|Kaplan-Meier product-limit|13.2|||||TWO_SIDED|97.5|2.5|97.5||Unadjusted p-value|Kaplan-Meier product-limit estimates|||Disease free survival time was evaluated with the product-limit estimator by Kaplan-Meier test.||97.5|2.5|
74048157|NCT05032755|147649238|SUPERIORITY||beta estimate|1.902|STANDARD_ERROR_OF_MEAN|0.398|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term|||||<.0001
74048158|NCT05032755|147649239|SUPERIORITY||beta estimate|0.368|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||<.0001
74097485|NCT01292226|147743877|SUPERIORITY_OR_OTHER|||||||0.963||||||IMPDH activity, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.9630
74097486|NCT01292226|147743878|SUPERIORITY_OR_OTHER|||||||0.413||||||IMPDH I|ANOVA|||||||0.4130
74097487|NCT01292226|147743878|SUPERIORITY_OR_OTHER|||||||0.3823||||||IMPDH II|ANOVA|||||||0.3823
74048159|NCT05032755|147649240|SUPERIORITY||beta estimate|0.672|STANDARD_ERROR_OF_MEAN|0.362||0.065|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.065
74048160|NCT05032755|147649241|SUPERIORITY||beta estimate|0.364|STANDARD_ERROR_OF_MEAN|0.133||0.007|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.007
74097488|NCT01292226|147743879|SUPERIORITY_OR_OTHER|||||||0.0316||||||IMPDH I|ANOVA|||||||0.0316
74097489|NCT01292226|147743879|SUPERIORITY_OR_OTHER|||||||0.944||||||IMPDH II|ANOVA|||||||0.9440
74097490|NCT01292226|147743880|SUPERIORITY_OR_OTHER|||||||0.1328||||||IMPDH I|ANOVA|||||||0.1328
74097491|NCT01292226|147743880|SUPERIORITY_OR_OTHER|||||||0.576||||||IMPDH II|ANOVA|||||||0.5760
74097492|NCT01292226|147743881|SUPERIORITY_OR_OTHER|||||||0.7332||||||Free MPA|ANOVA|||||||0.7332
74097493|NCT01292226|147743881|SUPERIORITY_OR_OTHER|||||||0.2681||||||Total MPA|ANOVA|||||||0.2681
74097494|NCT01292226|147743881|SUPERIORITY_OR_OTHER|||||||0.7087||||||AUC MPA|ANOVA|||||||0.7087
74097495|NCT01292226|147743882|SUPERIORITY_OR_OTHER|||||||0.9432||||||Free MPA|ANOVA|||||||0.9432
74097496|NCT01292226|147743882|SUPERIORITY_OR_OTHER|||||||0.5177||||||Total MPA|ANOVA|||||||0.5177
74097497|NCT01292226|147743882|SUPERIORITY_OR_OTHER|||||||0.6398||||||AUC MPA|ANOVA|||||||0.6398
73880906|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.72||||0.3139|TWO_SIDED|95.0|0.6|4.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.96|0.60|0.3139
74048161|NCT05032755|147649242|SUPERIORITY||beta estimate|1.78|STANDARD_ERROR_OF_MEAN|1.78||0.325|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 2 levels (pre- vs post-intervention). Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.325
74048162|NCT05032755|147649244|SUPERIORITY||beta estimate|0.222|STANDARD_ERROR_OF_MEAN|0.104||0.035|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.035
74048163|NCT05032755|147649245|SUPERIORITY||beta estimate|0.201|STANDARD_ERROR_OF_MEAN|0.181||0.27|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.27
74048164|NCT05032755|147649246|SUPERIORITY||beta estimate|-1.229|STANDARD_ERROR_OF_MEAN|1.037||0.24|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.24
74048165|NCT05032755|147649251|SUPERIORITY||beta estimate|4.69|STANDARD_ERROR_OF_MEAN|2.88||0.113|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 2 levels (pre- vs post-intervention). Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.113
74097498|NCT01292226|147743883|SUPERIORITY_OR_OTHER|||||||0.0656||||||Free MPA|ANOVA|||||||0.0656
74097499|NCT01292226|147743883|SUPERIORITY_OR_OTHER|||||||0.0131||||||Total MPA|ANOVA|||||||0.0131
74097500|NCT01292226|147743883|SUPERIORITY_OR_OTHER|||||||0.0515||||||AUC MPA|ANOVA|||||||0.0515
74097501|NCT01584843|147743884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.83||||0.091|TWO_SIDED|95.0|-21.81|2.14||LSD=Least Significant Difference|Fisher LSD method|||||2.14|-21.81|0.091
73880907|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6343|TWO_SIDED|95.0|0.45|3.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.76|0.45|0.6343
74048166|NCT01874353|147649271|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.22|<0.0001
74097502|NCT01584843|147743884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.08||||0.338|TWO_SIDED|95.0|-20.39|8.23|||Fisher LSD method|||||8.23|-20.39|0.338
74097503|NCT01584843|147743884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75||||0.524|TWO_SIDED|95.0|-9.83|17.33|||Fisher LSD method|||||17.33|-9.83|0.524
74097504|NCT01584843|147743884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.85||||0.031|TWO_SIDED|95.0|-24.46|-1.24|||Fisher LSD method|||||-1.24|-24.46|0.031
74097505|NCT01584843|147743884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.72||||0.005|TWO_SIDED|95.0|-28.06|-5.38|||Fisher LSD method|||||-5.38|-28.06|0.005
74097506|NCT01584843|147743884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.87||||0.49|TWO_SIDED|95.0|-15.21|7.47|||Fisher LSD method|||||7.47|-15.21|0.490
74097507|NCT00311402|147743920|NON_INFERIORITY_OR_EQUIVALENCE|The non-event rates after 1 year in the Aggrenox group and ASA group are estimated at 94.0% and 91.5%, respectively. The non-inferiority margin was set to 2%. Under these conditions, 500 patients per group were supposed to be enough to detect the non-inferiority of Aggrenox with over 80% power.|Cox Proportional Hazard|1.47||||0.097||95.0|0.93|2.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.31|0.93|0.097
74048167|NCT01874353|147649271|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.17|1.19||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours olaparib|||1.19|0.17|
74048168|NCT01874353|147649272|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0537|TWO_SIDED|95.0|0.54|1.0||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \<1 favours olaparib|||1.00|0.54|0.0537
74048169|NCT01874353|147649272|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.38|2.49||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \<1 favours olaparib|||2.49|0.38|
74048170|NCT01874353|147649273|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.23|<0.0001
74097508|NCT00311402|147743921|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.79||||0.223||95.0|0.7|4.54|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||4.54|0.70|0.223
74097509|NCT00311402|147743922|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.0||||0.998|ONE_SIDED|95.0|0.0||||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|||0|0.998
74097510|NCT00311402|147743923|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.02||||0.977||95.0|0.21|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||5.07|0.21|0.977
74097511|NCT00311402|147743924|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.58||||0.192||95.0|0.26|1.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.31|0.26|0.192
74097512|NCT00311402|147743925|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.88||||0.215||95.0|0.69|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||5.07|0.69|0.215
74097513|NCT00311402|147743926|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.16||||0.443||95.0|0.79|1.69|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.69|0.79|0.443
74097514|NCT00311402|147743927|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.52||||0.043||95.0|1.01|2.29|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.29|1.01|0.043
74097515|NCT00311402|147743928|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.919||95.0|0.48|2.25|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.25|0.48|0.919
74097516|NCT00311402|147743929|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.34||||0.101||95.0|0.94|1.91|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.91|0.94|0.101
74097517|NCT02640053|147743930|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
74097518|NCT02640053|147743931|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
74097519|NCT02640053|147743932|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
74097520|NCT02640053|147743933|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
74097521|NCT02640053|147743934|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
74097522|NCT02640053|147743935|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
74097523|NCT02640053|147743936|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
74097524|NCT02640053|147743937|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
74097525|NCT04159935|147743945|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
74097526|NCT04159935|147743946|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||||||0.057
74097527|NCT04159935|147743947|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
74097528|NCT04159935|147743949|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
74097529|NCT04159935|147743950|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
74097530|NCT04159935|147743951|OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
74097531|NCT04159935|147743952|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
74097532|NCT04159935|147743953|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
74097533|NCT04159935|147743955|OTHER|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||||||0.343
74097534|NCT04159935|147743956|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.700
74097535|NCT04159935|147743957|OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
74097536|NCT02036775|147743958|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|110.68|STANDARD_DEVIATION|20.42|||TWO_SIDED|90.0|99.84|122.69|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||122.69|99.84|
74097537|NCT02036775|147743958|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|STANDARD_DEVIATION|13.52|||TWO_SIDED|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||110.74|96.54|
74097538|NCT02036775|147743958|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|106.93|STANDARD_DEVIATION|12.65|||TWO_SIDED|90.0|100.29|114.02|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||114.02|100.29|
74097539|NCT02036775|147743959|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|84.72|STANDARD_DEVIATION|19.01|||TWO_SIDED|90.0|76.96|93.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||93.25|76.96|
74018715|NCT03569202|147589567|OTHER||Mean Difference (Final Values)|-1.7692||||0.6381|TWO_SIDED|95.0|-9.2785|5.7401||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||5.7401|-9.2785|0.6381
74018716|NCT03569202|147589568|OTHER||Mean Difference (Final Values)|0.8462||||0.271|TWO_SIDED|95.0|-0.6792|2.3715||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||2.3715|-0.6792|0.271
74018717|NCT03569202|147589568|OTHER||Mean Difference (Final Values)|1.7115||||0.0025|TWO_SIDED|95.0|0.633|2.7901||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||2.7901|0.6330|0.0025
74018718|NCT03569202|147589568|OTHER||Mean Difference (Final Values)|0.8654||||0.1134|TWO_SIDED|95.0|-0.2132|1.944||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||1.9440|-0.2132|0.1134
74018719|NCT03569202|147589569|OTHER||Mean Difference (Final Values)|2.1731||||0.412|TWO_SIDED|95.0|-3.1016|7.4477||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||7.4477|-3.1016|0.412
74018720|NCT03569202|147589569|OTHER||Mean Difference (Final Values)|0.01923||||0.9918|TWO_SIDED|95.0|-3.7105|3.749||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||3.7490|-3.7105|0.9918
74018721|NCT03569202|147589569|OTHER||Mean Difference (Final Values)|-2.1538||||0.2516|TWO_SIDED|95.0|-5.8836|1.5759||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||1.5759|-5.8836|0.2516
74018722|NCT03569202|147589570|OTHER||Mean Difference (Final Values)|0.5093||||0.047|TWO_SIDED|95.0|0.007267|1.0113||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||1.0113|0.007267|0.047
74018723|NCT03569202|147589570|OTHER||Mean Difference (Final Values)|0.5596||||0.0026|TWO_SIDED|95.0|0.2046|0.9146||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||0.9146|0.2046|0.0026
74018724|NCT03569202|147589570|OTHER||Mean Difference (Final Values)|0.05032||||0.777|TWO_SIDED|95.0|-0.3047|0.4053||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||0.4053|-0.3047|0.7770
74018725|NCT03569202|147589571|OTHER||Wilcoxon Z statistic|-0.7604||||0.447|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.447
74018726|NCT03569202|147589571|OTHER|||||||0.014||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.014
74018727|NCT03569202|147589571|OTHER|||||||0.07||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.070
74018728|NCT03569202|147589572|OTHER||Wilcoxon Z statistic|-0.6396||||0.522|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.522
74018729|NCT03569202|147589572|OTHER|||||||0.119||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.119
74018730|NCT03569202|147589572|OTHER|||||||0.9||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.900
74018731|NCT03569202|147589573|OTHER||Wilcoxon Z statistic|-0.5387||||0.59|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.590
74018732|NCT03569202|147589573|OTHER|||||||0.043||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.043
74018733|NCT03569202|147589573|OTHER|||||||0.442||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.442
74018734|NCT03569202|147589575|OTHER||Wilcoxon Z statistic|0.9208||||0.357|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.357
74018735|NCT03569202|147589575|OTHER|||||||0.001||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.001
74018736|NCT03569202|147589575|OTHER|||||||0.065||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.065
74018737|NCT03569202|147589576|OTHER||Wilcoxon Z statistic|1.044||||0.296|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.296
74018738|NCT03569202|147589576|OTHER|||||||0.012||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.012
74048171|NCT01874353|147649273|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.18|1.03||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \<1 favours olaparib|||1.03|0.18|
74097540|NCT02036775|147743959|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|103.87|STANDARD_DEVIATION|17.19|||TWO_SIDED|90.0|95.22|113.31|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||113.31|95.22|
74048172|NCT01874353|147649274|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5||||0.0002|TWO_SIDED|95.0|0.34|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.72|0.34|0.0002
74048173|NCT01874353|147649274|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.22|3.97||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes treatment factor only|A hazard ratio \< 1 favours olaparib|||3.97|0.22|
74048174|NCT01874353|147649275|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03||||0.9765|TWO_SIDED|95.0|-2.191|2.126|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.||||2.126|-2.191|0.9765
74048175|NCT01874353|147649276|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.28|0.48||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.48|0.28|<0.0001
74048176|NCT01874353|147649276|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.21|1.08||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours olaparib|||1.08|0.21|
74048177|NCT01874353|147649277|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.68||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.68|0.39|<0.0001
74048178|NCT01874353|147649277|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.37|1.85||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model included treatment factor only|A hazard ratio \< 1 favours olaparib|||1.85|0.37|
74048179|NCT01874353|147649278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.28|0.49||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.49|0.28|<0.0001
74048180|NCT01874353|147649278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.2|1.04||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours the Olaparib arm|||1.04|0.20|
74048181|NCT01874353|147649279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
74048182|NCT01327573|147649285|SUPERIORITY_OR_OTHER|||||||0.09||||||"This p-value was for the overall slope difference between groups (i.e. the interaction between group and time).~Significance level was set at 0.1 a priori."|Mixed effects model analysis|||Analysis used eGFR, group, time, and group-by-time variables.||||0.09
74048183|NCT03070119|147649300|SUPERIORITY||Least square (LS) geometric mean ratio|0.86|||||TWO_SIDED|95.0|0.69|1.08||||||Week 52 - The analysis was based on an analysis of covariance (ANCOVA) model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation (MI) including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.08|0.69|
74097541|NCT02036775|147743959|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|80.94|STANDARD_DEVIATION|17.95|||TWO_SIDED|90.0|73.92|88.62|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||88.62|73.92|
74048184|NCT03070119|147649300|SUPERIORITY||LS geometric mean ratio|0.91|||=|0.3711|TWO_SIDED|95.0|0.75|1.11|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.11|0.75|=0.3711
74097542|NCT02036775|147743960|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|88.54|STANDARD_DEVIATION|20.42|||TWO_SIDED|90.0|79.87|98.15|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||98.15|79.87|
74097543|NCT02036775|147743960|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|STANDARD_DEVIATION|13.52|||TWO_SIDED|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||110.74|96.54|
74097544|NCT02036775|147743960|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|85.55|STANDARD_DEVIATION|12.65|||TWO_SIDED|90.0|80.23|91.22|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||91.22|80.23|
74097545|NCT02036775|147743961|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|76.55|STANDARD_DEVIATION|14.55|||TWO_SIDED|90.0|71.1|82.4|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||82.40|71.10|
74097546|NCT02036775|147743961|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|100.46|STANDARD_DEVIATION|11.65|||TWO_SIDED|90.0|94.69|106.58|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||106.58|94.69|
74097547|NCT02036775|147743961|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|75.69|STANDARD_DEVIATION|15.64|||TWO_SIDED|90.0|69.92|81.93|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||81.93|69.92|
74097548|NCT03923530|147743969|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.12
74097549|NCT03923530|147743970|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.49
74097550|NCT03923530|147743971|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.03
74097551|NCT03923530|147743972|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.27
74097552|NCT03923530|147743973|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.18
74048185|NCT03070119|147649300|SUPERIORITY||LS geometric mean ratio|1.06|||=|0.6344|TWO_SIDED|95.0|0.84|1.34|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.34|0.84|=0.6344
74048186|NCT03070119|147649301|SUPERIORITY||LS geometric mean ratio|0.8|||||TWO_SIDED|95.0|0.63|1.03||||||Week 52 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.03|0.63|
74048187|NCT03070119|147649301|SUPERIORITY||LS geometric mean ratio|0.83|||=|0.2306|TWO_SIDED|95.0|0.6|1.13|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.13|0.60|=0.2306
74097553|NCT03923530|147743974|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.8
74097554|NCT03923530|147743975|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.76
74097555|NCT01158573|147744002|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Hypothesis that leptin levels in OA is not different from the other 3 groups.|ANOVA|||||||<0.0001
74097556|NCT01158573|147744003|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||0.002
74097557|NCT01158573|147744004|SUPERIORITY_OR_OTHER|||||||0.725|||||||ANOVA|||||||0.725
74097558|NCT01158573|147744005|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANOVA|||||||0.16
74097559|NCT03316378|147744055|SUPERIORITY||Mean Difference (Final Values)|73.8||||0.44|TWO_SIDED|||||Adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||0.44
74097560|NCT03316378|147744055|SUPERIORITY||Mean Difference (Final Values)|31.7||||0.08|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||0.08
74097561|NCT03316378|147744056|SUPERIORITY||Mean Difference (Final Values)|6.9|||<|0.001|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||<0.001
74097562|NCT03316378|147744056|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.012|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||0.012
74097563|NCT03316378|147744057|SUPERIORITY||Mean Difference (Final Values)|0.15||||1|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||1.0
74097564|NCT03316378|147744057|SUPERIORITY||Mean Difference (Final Values)|0.05||||1|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||1.0
74048188|NCT03070119|147649301|SUPERIORITY||LS geometric mean ratio|0.92|||=|0.673|TWO_SIDED|95.0|0.61|1.38|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.38|0.61|=0.6730
74048189|NCT03070119|147649302|SUPERIORITY||Least square (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|0.5|6.7||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||6.7|0.5|
74048190|NCT03070119|147649302|SUPERIORITY||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|2.28|=|0.1054|TWO_SIDED|95.0|-0.8|8.2|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||8.2|-0.8|=0.1054
74097565|NCT02288182|147744065|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Student's t-test comparing the group means was planned and performed (successfully). However, due to some outliers, the central tendencies have been reported as medians (instead of arithmetic means). Therefore an additional non-parameteric test (Mann-Whitney U-test) was performed.||||0.001
74097566|NCT02056392|147744079|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|90.0|-1.8|1.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.5|-1.8|
74048191|NCT03070119|147649302|SUPERIORITY||LS mean difference|3.6|STANDARD_ERROR_OF_MEAN|2.46|=|0.1432|TWO_SIDED|95.0|-1.2|8.4|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||8.4|-1.2|=0.1432
74048192|NCT03070119|147649303|SUPERIORITY||LS mean difference|8.1|STANDARD_ERROR_OF_MEAN|3.99|||TWO_SIDED|95.0|0.3|15.9||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||15.9|0.3|
74048193|NCT03070119|147649303|SUPERIORITY||LS mean difference|9.3|STANDARD_ERROR_OF_MEAN|5.6|=|0.0963|TWO_SIDED|95.0|-1.7|20.4|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||20.4|-1.7|=0.0963
74048194|NCT03070119|147649303|SUPERIORITY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|5.56|=|0.4388|TWO_SIDED|95.0|-6.6|15.2|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||15.2|-6.6|= 0.4388
74048195|NCT03070119|147649304|SUPERIORITY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.109|||TWO_SIDED|95.0|0.051|0.477||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.477|0.051|
74048196|NCT03070119|147649304|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.145|=|0.3207|TWO_SIDED|95.0|-0.141|0.43|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.430|-0.141|=0.3207
74048197|NCT03070119|147649304|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.091|=|0.5452|TWO_SIDED|95.0|-0.124|0.234|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.234|-0.124|=0.5452
74048198|NCT03070119|147649306|SUPERIORITY||Hazard Ratio (HR)|0.64|||=|0.4202|TWO_SIDED|95.0|0.282|1.461|||Log Rank|The analysis was based on a log rank test stratified by median baseline plasma NfL.|The analysis was based on a Cox proportional hazards model adjusted for baseline plasma NfL, and riluzole or edaravone use.|||1.461|0.282|=0.4202
73888096|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3||||0.1809|TWO_SIDED|95.0|-2.5|13.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.2|-2.5|0.1809
74097567|NCT02056392|147744079|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|6.1|||||TWO_SIDED|90.0|4.4|7.7|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||7.7|4.4|
74097568|NCT02056392|147744080|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|90.0|-2.0|1.3|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.3|-2.0|
74097569|NCT02056392|147744080|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.2|||||TWO_SIDED|90.0|7.6|10.8|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.8|7.6|
74097570|NCT02056392|147744081|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.9|||||TWO_SIDED|90.0|-0.7|2.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||2.5|-0.7|
74048199|NCT03070119|147649307|SUPERIORITY||Hazard Ratio (HR)|0.52|||=|0.3108|TWO_SIDED|95.0|0.199|1.357|||Log Rank|The analysis was based on a log rank test stratified by median baseline plasma NfL.|The analysis was based on a Cox proportional hazards model adjusted for baseline plasma NfL, and riluzole or edaravone use.|||1.357|0.199|=0.3108
74048200|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|2.777|||TWO_SIDED|95.0|-3.39|7.91|||||Day 1, Max HR|||7.91|-3.39|
74048201|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.922|||TWO_SIDED|95.0|-4.78|7.28|||||Day 7, Max HR|||7.28|-4.78|
74048202|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-2.37|8.91|||||Day 1, Max HR|||8.91|-2.37|
74048203|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|2.729|||TWO_SIDED|95.0|-7.89|3.39|||||Day 7, Max HR|||3.39|-7.89|
74048204|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.49|STANDARD_ERROR_OF_MEAN|2.899|||TWO_SIDED|95.0|1.59|13.39|||||Day 1, Max HR|||13.39|1.59|
74097571|NCT02056392|147744081|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.9|||||TWO_SIDED|90.0|8.3|11.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||11.5|8.3|
74048205|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|3.079|||TWO_SIDED|95.0|2.34|15.05|||||Day 7, Max HR|||15.05|2.34|
74048206|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|2.243|||TWO_SIDED|95.0|-4.8|4.34|||||Day 1, WM|||4.34|-4.80|
74048207|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.52|||TWO_SIDED|95.0|-5.09|5.4|||||Day 7, WM|||5.40|-5.09|
74048208|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|2.182|||TWO_SIDED|95.0|-2.12|6.77|||||Day 1, WM|||6.77|-2.12|
74048209|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|2.378|||TWO_SIDED|95.0|-7.48|2.45|||||Day 7, WM|||2.45|-7.48|
74048210|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.16|STANDARD_ERROR_OF_MEAN|2.282|||TWO_SIDED|95.0|1.51|10.81|||||Day 1, WM|||10.81|1.51|
74048211|NCT00732472|147649311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.06|STANDARD_ERROR_OF_MEAN|2.642|||TWO_SIDED|95.0|1.57|12.54|||||Day 7, WM|||12.54|1.57|
74048212|NCT01058395|147649333|SUPERIORITY|"Comparison between groups at 3 months (primary).~Comparison between the 2 tiers."||||||0.021||||||P-value|ANCOVA|Threshold for significance was P-value \< 0.05||DRS levels changes at from 4 weeks to 3 months comparing the different doses.||||0.021
74048213|NCT01058395|147649333|SUPERIORITY|||||||0.258|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 3 months.||||0.258
74048214|NCT01058395|147649333|SUPERIORITY|t-test||||||0.541|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 4 weeks.||||0.541
74048215|NCT01058395|147649335|SUPERIORITY||Mean Difference (Final Values)|176.0|||>|0.05|ONE_SIDED||||||t-test, 2 sided|||||||>0.05
74048216|NCT01266876|147649336|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 300 mg Q4W versus placebo~3. Alirocumab 200 mg Q4W versus placebo~4. Alirocumab 150 mg Q4W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."||||0.0000
74048217|NCT01266876|147649336|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0000
74048218|NCT01266876|147649336|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0035
74097572|NCT02056392|147744082|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|90.0|-1.2|2.0|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||2.0|-1.2|
74097573|NCT02056392|147744082|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.1|||||TWO_SIDED|90.0|8.5|11.8|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||11.8|8.5|
74097574|NCT02056392|147744083|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|90.0|-1.8|1.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.5|-1.8|
74097575|NCT02056392|147744083|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|11.9||||||90.0|10.3|13.6|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||13.6|10.3|
74048219|NCT01266876|147649336|SUPERIORITY_OR_OTHER|||||||0.0113|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0113
74048220|NCT01996865|147649367|OTHER||Hazard Ratio (HR)|0.8||||0.3296|TWO_SIDED|95.0|0.6|1.2|||Regression, Cox|||||1.2|0.6|0.3296
74048221|NCT01996865|147649368|OTHER||Hazard Ratio (HR)|0.7||||0.1222|TWO_SIDED|95.0|0.4|1.1|||Regression, Cox|||||1.1|0.4|0.1222
74048222|NCT04083781|147649380|SUPERIORITY|Analyses of count endpoints were analysed using a negative binomial regression model with the logarithm of the length of the observation period included (in years) as an offset with randomised treatment regimen, type of haemophilia (HAwI or HBwI) and bleeding frequency (less than 9 or greater than or equal to 9 bleeding episodes during the past 24 weeks prior to screening) as factors comparing arm 1 (on-demand treatment) and arm 2.|Annualised bleeding rate ratio|0.14|||<|0.001|TWO_SIDED|95.0|0.07|0.29|||Two-sided test of no difference from 1|||||0.29|0.07|<0.001
74048223|NCT03733132|147649433|SUPERIORITY|||||||0.854|||||||t-test, 2 sided|||||||0.854
74048224|NCT03733132|147649434|SUPERIORITY|||||||0.389|||||||t-test, 2 sided|||||||0.389
74097576|NCT02056392|147744084|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.5|||||TWO_SIDED|90.0|-3.1|0.2|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||0.2|-3.1|
74048225|NCT03733132|147649435|SUPERIORITY|||||||0.609|||||||t-test, 2 sided|||||||0.609
74048226|NCT03733132|147649436|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||0.371
74048227|NCT03733132|147649437|SUPERIORITY|||||||0.686|||||||t-test, 2 sided|||||||0.686
74097577|NCT02056392|147744084|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.8|||||TWO_SIDED|90.0|9.2|12.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||12.5|9.2|
74097578|NCT02056392|147744085|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|90.0|-3.4|-0.1|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-0.1|-3.4|
74048228|NCT00557362|147649508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.098||||0.29|TWO_SIDED|95.0|-0.28|0.083|||Regression, Linear|Multiple linear regression model adjusted for enrollment BSCVA and corneal de-epithelialization||||0.083|-0.28|0.29
74048229|NCT00557362|147649509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.4|TWO_SIDED|95.0|0.76|2.02|||Regression, Cox|||||2.02|0.76|0.40
74048230|NCT00557362|147649510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.37|TWO_SIDED|95.0|-0.2|0.53|||Regression, Linear|||||0.53|-0.20|0.37
74048231|NCT00557362|147649511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.62|TWO_SIDED|95.0|-0.25|0.41|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was examined in a linear regression model with enrollment BSCVA and treatment arm as covariates among a subgroup of ulcers caused by Fusarium spp.||0.41|-0.25|0.62
74048232|NCT00557362|147649511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.26|TWO_SIDED|95.0|-0.57|0.17|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was evaluated in a linear regression model with enrollment BSCVA and treatment arm as covariates in a subgroup of ulcers caused by Aspergillus spp.||0.17|-0.57|0.26
74048233|NCT00557362|147649512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.53|TWO_SIDED|95.0|-0.26|0.14|||Regression, Linear|||||0.14|-0.26|0.53
74048234|NCT02268942|147649678|OTHER|||||||0.0003|||||||Exact Binomial|||"Success at six months is estimated to be 86% compared to a performance goal of 77.5%. Using an exact binomial test, with a one-sided alpha of 0.05, and 80% Power, a sample size of 145 implanted subjects was planned.~Success will be met if the lower bound of the upper one-sided exact 95% confidence interval is greater than 77.5%."||||0.0003
74048235|NCT02268942|147649679|OTHER||||||<|0.0001|||||||t-test, 1 sided|||"The secondary endpoint is an improvement in the mean length of initial hospital stay (initial recovery and step down unit), which is calculated by considering the number of days in acute care (ICU/CCU) plus the number of days in intermediate/step-down care, comprising the total number of days post-implant to discharge.~This secondary endpoint will be calculated using an upper tail one-sided t-test at 0.05 level of significance compared to 26.1 days for median sternotomy patients."||||<0.0001
74048236|NCT01332851|147649720|SUPERIORITY||Cox Proportional Hazard|2.5|||=|0.043|TWO_SIDED|95.0|1.03|6.1||We used a threshold of p \< .05 as the criterion for statistical significance.|Regression, Cox||The hazard ratio of 2.5 indicates that children with parents in the control group were 2.5 times more likely to be removed from their home and placed into foster care compared to the intervention group.|Child welfare system removals were analyzed with a survival models that used condition assignment to predict hazard of being removed from the birth parent home.||6.10|1.03|=.043
74048237|NCT01332851|147649721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|0.42|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Parents in the PFR condition were 0.94 higher on sensitivity scores (on the unstandardized sensitivity measure) across the three post-intervention time points than parents in the R\&R condition. The standard error (SE) of this difference was .42.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline sensitivity score, months between baseline and end of intervention, and age of child at baseline.||||<.05
74097579|NCT02056392|147744085|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.8|||||TWO_SIDED|90.0|7.1|10.4|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.4|7.1|
74048238|NCT01332851|147649722|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had a higher mean compared to the R\&R group. (the absolute value of the standardized effect is d=.15).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline security score, months between baseline and end of intervention, and age of child at baseline||||>.05
74048239|NCT01332851|147649723|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.5|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The adjusted mean across the two post-intervention time points was -.20 (SE=.50) lower in the PFR group than R\&R group. The standardized effect size was d=.04.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline.||||>.05
74048240|NCT01332851|147649724|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.53|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The adjusted mean across post-intervention time points was .41 (SE=.53) higher in the PFR group than the R\&R group. The standardized effect size was d=-.07|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline competence stress score, months between baseline and end of intervention, and age of child at baseline||||>.05
74048241|NCT01332851|147649725|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.25|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had a higher mean level of social and emotional development compared to the R\&R group (the absolute value of the standardized effect is d=.10).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline social-emotional competence score, months between baseline and end of intervention, and age of child at baseline.||||>.05
74048242|NCT01332851|147649726|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.66|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had lower mean level of problem behavior compared to the R\&R group (the absolute value of standardized effect is d= .12).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline||||>.05
74048243|NCT01332851|147649727|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.07 (SE=.08) lower for PFR compared to R\&R group.|Tested mean differences by condition at 3-month follow-up controlling for baseline score, months between baseline and the end of the intervention, and age of child and using an ANVOVA/regression model. Null hypothesis was that post-intervention means were equal.||||>.05
74097580|NCT02056392|147744086|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|90.0|-2.9|0.4|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||0.4|-2.9|
74097581|NCT02056392|147744086|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.9|||||TWO_SIDED|90.0|7.2|10.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.5|7.2|
73888097|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.856|TWO_SIDED|95.0|-7.1|8.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.5|-7.1|0.8560
74097582|NCT02056392|147744087|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-4.7|||||TWO_SIDED|90.0|-6.4|-3.1|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-3.1|-6.4|
74097583|NCT02056392|147744087|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|7.6|||||TWO_SIDED|90.0|6.0|9.3|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||9.3|6.0|
74097584|NCT02056392|147744088|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-2.5|||||TWO_SIDED|90.0|-4.1|-0.9|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-0.9|-4.1|
74097585|NCT02056392|147744088|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|4.0|||||TWO_SIDED|90.0|2.4|5.7|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||5.7|2.4|
74097586|NCT02022748|147744091|OTHER||Ratio of Geometric Least Square Means|151.13|||||TWO_SIDED|90.0|112.03|203.86|||||Treatment H is the reference treatment.|||203.86|112.03|
74048244|NCT01332851|147649728|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.06 (SE=.08) lower for PFR compared to R\&R group.|||||>.05
74048245|NCT01332851|147649729|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had lower atypical affective communication compared to the R\&R group (the absolute value of the standardized effect size was d=.19).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline score, months between baseline and end of intervention, and age of child at baseline||||<.05
74048246|NCT03299166|147649742|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.81||0.2202|TWO_SIDED|95.0|-2.59|0.6|||Mixed Models Analysis|||Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.||0.60|-2.59|0.2202
74048247|NCT03299166|147649749|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.61||0.4508|TWO_SIDED|95.0|-1.67|0.75|||Mixed Models Analysis|||"Week 4 Analysis.~Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect."||0.75|-1.67|0.4508
74048248|NCT03299166|147649749|SUPERIORITY||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.75||0.041|TWO_SIDED|95.0|-3.02|-0.06|||Mixed Models Analysis|||"Week 8 Analysis.~Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect."||-0.06|-3.02|0.0410
74048249|NCT00255008|147649750|SUPERIORITY_OR_OTHER||Proportion of patients (%)|80.0||||||95.0|28.36|99.49||||||||99.49|28.36|
74048250|NCT00255008|147649750|SUPERIORITY_OR_OTHER||Proportion of patients (%)|76.47||||||95.0|50.1|93.19||||||||93.19|50.10|
74048251|NCT00255008|147649750|SUPERIORITY_OR_OTHER||Proportion of patients (%)|87.5||||||95.0|47.35|99.48||||||||99.48|47.35|
74097587|NCT02022748|147744091|OTHER||Ratio of Geometric Least Square Means|161.38|||||TWO_SIDED|90.0|122.52|212.58|||||Treatment H is the reference treatment.|||212.58|122.52|
74097588|NCT02022748|147744091|OTHER||Ratio of Geometric Least Square Means|90.1|||||TWO_SIDED|90.0|78.07|103.98|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||103.98|78.07|
74048252|NCT01833806|147649751|SUPERIORITY||Proportion Difference|0.78|||=|0.01|TWO_SIDED|95.0|0.58|0.98|||Binomial|||The alternative hypothesis test was that the proportion of Responders would be greater than the proportion of subjects experiencing pain progression. This PAS was powered to enroll 70 subjects based on the pivotal trial proportion of 18:8 (Responders:Pain progression). The study was closed at an enrollment of 32 subjects.||0.98|0.58|= 0.01
74048253|NCT02858713|147649758|SUPERIORITY||Odds Ratio (OR)|2.99|||=|0.004|TWO_SIDED|95.0|1.42|6.28|||Regression, Logistic|||||6.28|1.42|=0.004
74048254|NCT02858713|147649759|SUPERIORITY||Coefficient|-0.415|||=|0.545|TWO_SIDED|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change baseline to week 4||0.939|-1.770|=0.545
74048255|NCT02858713|147649759|SUPERIORITY||Coefficient|-0.415||||0.545|TWO_SIDED|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change from baseline to week 4||0.939|-1.770|0.545
74048256|NCT02858713|147649759|SUPERIORITY||Coefficient|-0.581||||0.45|TWO_SIDED|95.0|-2.099|0.938|||Regression, Linear|||DLQI: Change from baseline to week 8||0.938|-2.099|0.450
74048257|NCT02858713|147649759|SUPERIORITY||Coefficient|-0.77||||0.348|TWO_SIDED|95.0|-2.389|0.848|||Regression, Linear|||DLQI: Change from baseline to week 26||0.848|-2.389|0.348
74048258|NCT02858713|147649760|SUPERIORITY||coefficient|0.4||||0.047|TWO_SIDED|95.0|0.005|0.795|||Regression, Linear|||LS-PGA: Change from baseline to week 4||0.795|0.005|0.047
74048259|NCT02858713|147649760|SUPERIORITY||Coefficient|0.091||||0.662|TWO_SIDED|95.0|-0.321|0.504|||Regression, Linear|||LS-PGA: Change from baseline to week 8||0.504|-0.321|0.662
74048260|NCT02858713|147649760|SUPERIORITY||Coefficient|0.18||||0.424|TWO_SIDED|95.0|-0.264|0.625|||Regression, Linear|||LS-PGA: Change from baseline to week 26||0.625|-0.264|0.424
74097589|NCT02022748|147744092|OTHER||Ratio of Geometric Least Square Means|117.09|||||TWO_SIDED|90.0|84.51|162.22|||||Treatment H is the reference treatment.|||162.22|84.51|
74097590|NCT02022748|147744092|OTHER||Ratio of Geometric Least Square Means|136.27|||||TWO_SIDED|90.0|95.38|194.7|||||Treatment H is the reference treatment.|||194.70|95.38|
74097591|NCT02022748|147744092|OTHER||Ratio of Geometric Least Square Means|82.29|||||TWO_SIDED|90.0|68.43|98.96|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||98.96|68.43|
74097592|NCT02022748|147744093|OTHER||Ratio of Geometric Least Square Means|137.75|||||TWO_SIDED|90.0|105.7|179.52|||||Treatment H is the reference treatment.|||179.52|105.70|
74097593|NCT02022748|147744093|OTHER||Ratio of Geometric Least Square Means|148.76|||||TWO_SIDED|90.0|115.07|192.32|||||Treatment H is the reference treatment.|||192.32|115.07|
74097594|NCT02022748|147744093|OTHER||Ratio of Geometric Least Square Means|90.35|||||TWO_SIDED|90.0|77.55|105.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||105.27|77.55|
74097595|NCT02022748|147744094|OTHER||Ratio of Geometric Least Square Means|112.73|||||TWO_SIDED|90.0|88.61|143.42|||||Treatment H is the reference treatment.|||143.42|88.61|
74097596|NCT02022748|147744094|OTHER||Ratio of Geometric Least Square Means|114.37|||||TWO_SIDED|90.0|91.19|143.45|||||Treatment H is the reference treatment.|||143.45|91.19|
74097597|NCT02022748|147744094|OTHER||Ratio of Geometric Least Square Means|93.13|||||TWO_SIDED|90.0|80.31|108.0|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||108.00|80.31|
74097598|NCT02022748|147744095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|90.0|-0.97|0.75|||||Treatment A - Treatment H.|||0.75|-0.97|
74097599|NCT02022748|147744095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|90.0|-0.96|1.52|||||Treatment B - Treatment H.|||1.52|-0.96|
74097600|NCT02022748|147744095|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.36|||||TWO_SIDED|90.0|-1.73|1.02|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.|||1.02|-1.73|
74097601|NCT02022748|147744096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||||TWO_SIDED|90.0|-2.62|0.48|||||Treatment A - Treatment H.|||0.48|-2.62|
74097602|NCT02022748|147744096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05|||||TWO_SIDED|90.0|-2.46|0.37|||||Treatment B - Treatment H.|||0.37|-2.46|
74097603|NCT02022748|147744096|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.5|||||TWO_SIDED|90.0|-1.27|0.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.|||0.27|-1.27|
74097604|NCT00461253|147744097|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.88|1.12|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD; adjusted for BMI, family history of breast cancer, age at first birth, age at menarche and physical activity (primary analysis)|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.12|0.88|
74097605|NCT00461253|147744097|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.93|1.17|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD, crude|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.17|0.93|
74097606|NCT00461253|147744097|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.52|1.39|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis; adjusted for BMI, family history of breast cancer, age at first birth, age at first menarche, physical activity (primary analysis)"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.39|0.52|
73888098|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7||||0.2385|TWO_SIDED|95.0|-3.1|12.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.4|-3.1|0.2385
74097607|NCT00461253|147744097|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.58|1.41|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis, crude"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.41|0.58|
74097608|NCT04240392|147744098|SUPERIORITY||Odds Ratio (OR)|1.369||||0.534|TWO_SIDED|95.0|0.462|4.055|||Mixed Models Analysis|Generalized Linear Mixed Model||||4.055|0.462|0.5340
74097609|NCT04240392|147744099|SUPERIORITY||Odds Ratio (OR)|0.803||||0.6|TWO_SIDED|95.0|0.326|1.979|||Mixed Models Analysis|Generalized Linear Mixed Model||At delivery||1.979|0.326|0.600
74097610|NCT04240392|147744099|SUPERIORITY||Odds Ratio (OR)|0.709||||0.471|TWO_SIDED|95.0|0.254|1.975|||Mixed Models Analysis|Generalized Linear Mixed Model||At 3 months post partum||1.975|0.254|0.471
74097611|NCT04240392|147744100|SUPERIORITY||Beta-coefficient|1.53||||0.518|TWO_SIDED|95.0|-3.13|6.19|||Mixed Models Analysis|Repeated Measures Linear Mixed Model|Beta-coefficient for treatment for time interaction term|At week 36||6.19|-3.13|0.518
74097612|NCT04240392|147744100|SUPERIORITY||Beta-coefficient|0.32||||0.893|TWO_SIDED|95.0|-4.41|5.06|||Mixed Models Analysis|Repeated Measures Linear Mixed Model|Beta-coefficient for treatment for time interaction term|At 3 months post partum||5.06|-4.41|0.893
74097613|NCT04086407|147744121|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
74097614|NCT04086407|147744122|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
74097615|NCT04086407|147744123|OTHER||||||||||||||||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||
74097616|NCT04086407|147744124|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
74097617|NCT01555671|147744125|OTHER||Mean Difference (Net)|30.0||||0.029|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.029
74097618|NCT00372411|147744128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.17||||0.08|TWO_SIDED|95.0|-0.23|4.58||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||4.58|-0.23|0.08
74097619|NCT00372411|147744128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.88||||0.02|TWO_SIDED|95.0|0.57|5.18||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||5.18|0.57|0.02
74097620|NCT00372411|147744128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.92|TWO_SIDED|95.0|-2.94|2.65||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||2.65|-2.94|0.92
73888099|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7||||0.3479|TWO_SIDED|95.0|-4.1|11.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.5|-4.1|0.3479
74097621|NCT00372411|147744128|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.58||||0.63|TWO_SIDED|95.0|-2.97|1.81||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||1.81|-2.97|0.63
74097622|NCT00372411|147744129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.64||||0.009|TWO_SIDED|95.0|2.03|13.24||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||13.24|2.03|0.009
74097623|NCT00372411|147744129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.95||||0.04|TWO_SIDED|95.0|0.34|11.56||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||11.56|0.34|0.04
74048261|NCT00126425|147649761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.83||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.83|0.23|=0.004
74048262|NCT00126425|147649761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.84|0.23|=0.004
74048263|NCT00126425|147649761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.84|0.23|=0.004
74048264|NCT04474366|147649764|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||||||0.72
74048265|NCT02141854|147649806|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.179||||0.0009|TWO_SIDED|95.0|0.074|0.285||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.||0.285|0.074|0.0009
74048266|NCT02141854|147649806|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.182||||0.001|TWO_SIDED|95.0|0.074|0.291||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.||0.291|0.074|0.0010
74048267|NCT02141854|147649806|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.326||||0|TWO_SIDED|95.0|0.221|0.431||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.||0.431|0.221|0.0000
74048268|NCT02141854|147649806|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.322||||0|TWO_SIDED|95.0|0.212|0.432||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.||0.432|0.212|0.0000
74048269|NCT02141854|147649807|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.276||||0|TWO_SIDED|95.0|0.191|0.361||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.||0.361|0.191|0.0000
74048270|NCT02141854|147649807|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.274||||0|TWO_SIDED|95.0|0.189|0.36||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.||0.360|0.189|0.0000
74048271|NCT02141854|147649807|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.183||||0|TWO_SIDED|95.0|0.098|0.268||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.||0.268|0.098|0.0000
74048272|NCT02141854|147649807|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.123||||0.0047|TWO_SIDED|95.0|0.038|0.208||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.||0.208|0.038|0.0047
74097624|NCT00372411|147744129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.81|TWO_SIDED|95.0|-3.87|4.94||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||4.94|-3.87|0.81
74048273|NCT02141854|147649808|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|18.45||||0|TWO_SIDED|95.0|11.751|25.15||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||25.150|11.751|0.0000
74097625|NCT00372411|147744129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19||||0.55|TWO_SIDED|95.0|-2.74|5.12||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||5.12|-2.74|0.55
73880908|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6557|TWO_SIDED|95.0|0.45|3.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.61|0.45|0.6557
73880909|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0516|TWO_SIDED|95.0|0.99|13.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.51|0.99|0.0516
74018739|NCT03569202|147589576|OTHER||||||>|0.05||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||>0.05
74018740|NCT03569202|147589578|OTHER||Mean Difference (Final Values)|-1.9911||||0.764|TWO_SIDED|95.0|-15.6117|11.6295||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||11.6295|-15.6117|0.764
74018741|NCT03569202|147589578|OTHER||Mean Difference (Final Values)|-17.0625||||0.0038|TWO_SIDED|95.0|-27.928|-6.197||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-6.1970|-27.9280|0.0038
74018742|NCT03569202|147589578|OTHER||Mean Difference (Final Values)|-15.0714||||0.0011|TWO_SIDED|95.0|-23.285|-6.8579||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-6.8579|-23.2850|0.0011
74018743|NCT01175005|147589626|SUPERIORITY_OR_OTHER|||||||0.001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
74018744|NCT02397473|147589627|SUPERIORITY||LSMean Difference|-3.47|STANDARD_ERROR_OF_MEAN|1.63||0.036|TWO_SIDED|95.0|-6.72|-0.23|||Mixed Models Analysis|||||-0.23|-6.72|0.036
74018745|NCT02397473|147589628|SUPERIORITY|||||||0.046|||||||ANCOVA|Koch's nonparametric randomization-based ANCOVA.||||||0.046
74018746|NCT02397473|147589629|SUPERIORITY||LSMean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.2||0.493|TWO_SIDED|95.0|-3.23|1.57|||Mixed Models Analysis|||||1.57|-3.23|0.493
74018747|NCT02397473|147589630|SUPERIORITY||Odds Ratio (OR)|3.046||||0.016|TWO_SIDED|95.0|1.242|7.469|||Mixed Models Analysis|||||7.469|1.242|0.016
74018748|NCT02397473|147589631|SUPERIORITY||Odds Ratio (OR)|1.312||||0.575|TWO_SIDED|95.0|0.502|3.426|||Mixed Models Analysis|||||3.426|.502|0.575
74018749|NCT02397473|147589632|SUPERIORITY||Odds Ratio (OR)|0.965||||0.91|TWO_SIDED|95.0|0.512|1.819|||Mixed Models Analysis|Pseudo-likelihood-based repeated measures.||||1.819|.512|0.910
74018750|NCT02397473|147589633|SUPERIORITY||Odds Ratio (OR)|0.929||||0.841|TWO_SIDED|95.0|0.449|1.923|||Mixed Models Analysis|Pseudolikelihood-based repeated measures model||||1.923|0.449|0.841
74018751|NCT00254566|147589645|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-0.9||||||95.0|-5.8|3.9|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence Interval|95% Confidence Interval (CI) for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.||3.9|-5.8|
74018752|NCT00254566|147589646|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in the percentage of participants with Cure and the 95% CI|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.||3.4|-8.5|
74018753|NCT00254566|147589647|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciprocal of the variance. Stratification will be by steroid use at time of randomization.||3.4|-8.5|
74018754|NCT00254566|147589648|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||||95.0|-4.5|3.3|||||Risk difference is the difference in eradication rates of pathogens by treatment|||3.3|-4.5|
74018755|NCT00254566|147589649|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.33||||0.159||95.0|0.9|2.0||p-value was estimated from Cox's Proportional Hazard model with steriod use and country as factors and baseline FEV1 fitted as covariate|Regression, Cox|||Kaplan-Meier method was used to estimate time taken for 1st 25th quartile of subjects to experience recurrence of AECB. Estimate of median time to event couldn't be calculated because \<50% of subjects in analysis population experienced a recurrence. The ratio of the treatment groups' recurrence rate (hazard ratio) estimated using Cox proportional hazards model adjusting for steroid use, frequency of AECB in previous 12 months, country and baseline Forced expiratory volume in 1 second (FEV1).||2.0|0.9|0.159
74018756|NCT00254566|147589650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.57||95.0|-0.21|0.12|||ANCOVA|Estimated from ANCOVA with treatment, steriod use, and country fitted as factor and baseline CCQ total scores and FEV1 fitted as covariates||||0.12|-0.21|0.57
74018757|NCT00254566|147589650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.82||95.0|-0.13|0.1|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.10|-0.13|0.82
74018758|NCT00254566|147589651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.81||95.0|-0.21|0.17|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.17|-0.21|0.81
74018759|NCT00254566|147589651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.87||95.0|-0.12|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.14|-0.12|0.87
74048274|NCT02141854|147649808|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|16.718||||0|TWO_SIDED|95.0|9.988|23.449||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||23.449|9.988|0.0000
74048275|NCT02141854|147649808|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|31.221||||0|TWO_SIDED|95.0|24.513|37.93||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||37.930|24.513|0.0000
74048276|NCT02141854|147649808|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|29.597||||0|TWO_SIDED|95.0|22.839|36.354||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||36.354|22.839|0.0000
74048277|NCT02141854|147649808|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|12.771||||0.0002|TWO_SIDED|95.0|6.179|19.363||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.363|6.179|0.0002
74048278|NCT02141854|147649808|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|12.879||||0.0002|TWO_SIDED|95.0|6.216|19.541||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.541|6.216|0.0002
74048279|NCT02141854|147649808|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|11.146||||0.001|TWO_SIDED|95.0|4.511|17.782||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||17.782|4.511|0.0010
74048280|NCT02141854|147649809|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.156||||0.001|TWO_SIDED|95.0|-0.248|-0.063||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.063|-0.248|0.0010
74048281|NCT02141854|147649809|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.195||||0|TWO_SIDED|95.0|-0.288|-0.102||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.102|-0.288|0.0000
74048282|NCT02141854|147649809|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.304||||0|TWO_SIDED|95.0|-0.397|-0.212||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.212|-0.397|0.0000
74048283|NCT02141854|147649809|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.277||||0|TWO_SIDED|95.0|-0.37|-0.184||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.184|-0.370|0.0000
74048284|NCT02141854|147649809|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.149||||0.0014|TWO_SIDED|95.0|-0.239|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.058|-0.239|0.0014
74097626|NCT00372411|147744130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.41||||0.22|TWO_SIDED|95.0|-11.52|2.7||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||2.70|-11.52|0.22
74097627|NCT00372411|147744130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.1||||0.005|TWO_SIDED|95.0|-13.61|-2.6||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||-2.60|-13.61|0.005
74097628|NCT00372411|147744130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.93||||0.82|TWO_SIDED|95.0|-7.03|8.89||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||8.89|-7.03|0.82
74048285|NCT02141854|147649809|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.082||||0.0818|TWO_SIDED|95.0|-0.174|0.01||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.010|-0.174|0.0818
74048286|NCT02141854|147649809|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.121||||0.0094|TWO_SIDED|95.0|-0.213|-0.03||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.030|-0.213|0.0094
74048287|NCT02141854|147649810|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.702||||0|TWO_SIDED|95.0|-1.001|-0.403||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.403|-1.001|0.0000
74048288|NCT02141854|147649810|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.607||||0.0001|TWO_SIDED|95.0|-0.908|-0.307||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.307|-0.908|0.0001
74048289|NCT02141854|147649810|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.066||||0|TWO_SIDED|95.0|-1.365|-0.766||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.766|-1.365|0.0000
74048290|NCT02141854|147649810|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.989||||0|TWO_SIDED|95.0|-1.291|-0.686||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.686|-1.291|0.0000
74048291|NCT02141854|147649810|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.364||||0.016|TWO_SIDED|95.0|-0.659|-0.068||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.068|-0.659|0.0160
74048292|NCT02141854|147649810|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.382||||0.0124|TWO_SIDED|95.0|-0.681|-0.083||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.083|-0.681|0.0124
74048293|NCT02141854|147649810|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.287||||0.0588|TWO_SIDED|95.0|-0.584|0.011||Significance level of 0.05.|Wilcoxon (Mann-Whitney)|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.011|-0.584|0.0588
74048294|NCT02141854|147649811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Significance level of 0.05.|Log Rank|||||||0.0001
74048295|NCT02141854|147649811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Significance level of 0.05.|Log Rank|||||||<.0001
74048296|NCT02141854|147649811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||||||Significance level of 0.05.|Log Rank|||||||0.0003
74048297|NCT02141854|147649811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Significance level of 0.05.|Log Rank|||||||<.0001
74048298|NCT02141854|147649811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7203||||||Significance level of 0.05.|Log Rank|||||||0.7203
74097629|NCT00372411|147744130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.13||||0.55|TWO_SIDED|95.0|-9.2|4.93||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||4.93|-9.20|0.55
74048299|NCT02141854|147649811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.996||||||Significance level of 0.05.|Log Rank|||||||0.9960
74048300|NCT02141854|147649811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.325||||||Significance level of 0.05.|Log Rank|||||||0.3250
73880910|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.38||||0.04|TWO_SIDED|95.0|1.07|17.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||17.91|1.07|0.0400
74048301|NCT02141854|147649812|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.473||||0|TWO_SIDED|95.0|0.269|0.677||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.677|0.269|0.0000
74048302|NCT02141854|147649812|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.428||||0|TWO_SIDED|95.0|0.224|0.632||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.632|0.224|0.0000
74048303|NCT02141854|147649812|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.623||||0|TWO_SIDED|95.0|0.418|0.828||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.828|0.418|0.0000
74048304|NCT02141854|147649812|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.681||||0|TWO_SIDED|95.0|0.478|0.885||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.885|0.478|0.0000
74048305|NCT02141854|147649812|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.15||||0.149|TWO_SIDED|95.0|-0.054|0.354||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.354|-0.054|0.1490
74048306|NCT02141854|147649812|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.253||||0.0143|TWO_SIDED|95.0|0.051|0.455||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.455|0.051|0.0143
74048307|NCT02141854|147649812|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.209||||0.0435|TWO_SIDED|95.0|0.006|0.411||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.411|0.006|0.0435
74048308|NCT03057106|147649823|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.46|TWO_SIDED|90.0|0.67|1.16||2-sided, adjusted for stratification factors at rtandomization.|Log Rank|||||1.16|0.67|0.46
74097630|NCT00372411|147744131|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.08|TWO_SIDED|95.0|-1.73|0.11||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||0.11|-1.73|0.08
73880911|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.37||||0.5825|TWO_SIDED|95.0|0.44|4.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.24|0.44|0.5825
73880912|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|7.46||||0.0152|TWO_SIDED|95.0|1.47|37.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||37.83|1.47|0.0152
73880913|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1565|TWO_SIDED|95.0|0.73|7.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.30|0.73|0.1565
73880914|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.45||||0.4932|TWO_SIDED|95.0|0.5|4.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.25|0.50|0.4932
74048309|NCT03057106|147649824|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0035|TWO_SIDED|95.0|0.52|0.88||2-sided, adjusted for stratification factors at randomization.|Log Rank|Adjusted for stratification factors at randomization.||||0.88|0.52|0.0035
74048310|NCT03057106|147649825|SUPERIORITY||Odds Ratio (OR)|1.69||||0.033|TWO_SIDED|95.0|1.04|2.76||2-sided, adjusted for stratification factors at randomization.|Cochran-Mantel-Haenszel|||||2.76|1.04|0.033
74048311|NCT03991936|147649827|SUPERIORITY||Mean Difference (Net)|-2.635|||<|0.001|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|t-test, 2 sided|||The null hypothesis was that the change from baseline to 24 weeks in the Nail Psoriasis Severity Index (NAPSI) for the triamcinolone acetonide groups: 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10 mg/mL would be no different than the change from baseline to 24 weeks for the placebo group.||||<0.001
74048312|NCT05306964|147649886|OTHER|||||||0.5|||||||GLMM|||||||0.5
74048313|NCT05306964|147649887|OTHER|||||||0.4|||||||GLMM|||||||0.4
74048314|NCT05306964|147649888|OTHER|||||||0.5|||||||GLMM|||||||0.5
74048315|NCT05306964|147649889|OTHER|||||||0.3|||||||GLMM|||||||0.3
74048316|NCT05306964|147649890|OTHER|||||||0.4|||||||GLMM|||||||0.4
74048317|NCT05306964|147649891|OTHER|||||||0.5|||||||GLMM|||||||0.5
74048318|NCT05306964|147649892|OTHER|||||||0.3|||||||GLMM|||||||0.3
74048319|NCT05306964|147649893|OTHER|||||||0.3|||||||GLMM|||||||0.3
74048320|NCT05306964|147649894|OTHER|||||||0.7|||||||GLMM|||||||0.7
74048321|NCT05306964|147649895|OTHER|||||||0.2|||||||GLMM|||||||0.2
74048322|NCT05306964|147649896|OTHER|||||||0.02|||||||GLMM|||||||0.02
74048323|NCT05306964|147649897|OTHER|||||||0.2|||||||GLMM|||||||0.2
74048324|NCT05306964|147649898|OTHER|||||||0.7|||||||GLMM|||||||0.7
74048325|NCT05306964|147649899|OTHER|||||||0.1|||||||GLMM|||||||0.1
74048326|NCT05306964|147649900|OTHER|||||||0.2|||||||GLMM|||||||0.2
74048327|NCT05306964|147649901|OTHER||||||<|0.001|||||||GLMM|||||||<0.001
74048328|NCT05306964|147649902|OTHER|||||||0|||||||GLMM|||||||0
74048329|NCT05306964|147649903|OTHER|||||||0.5|||||||GLMM|||||||0.5
74048330|NCT05306964|147649904|OTHER|||||||0.9|||||||GLMM|||||||0.9
74048331|NCT05306964|147649905|OTHER|||||||0.8|||||||GLMM|||||||0.8
74048332|NCT05306964|147649906|OTHER|||||||0|||||||GLMM|||||||0
74048333|NCT05306964|147649907|OTHER|||||||0|||||||GLMM|||||||0
74048334|NCT05306964|147649908|OTHER|||||||0.2|||||||GLMM|||||||0.2
74048335|NCT05306964|147649909|OTHER|||||||0|||||||GLMM|||||||0
74048336|NCT05306964|147649910|OTHER|||||||0.9|||||||GLMM|||||||0.9
74048337|NCT05306964|147649911|OTHER|||||||0|||||||GLMM|||||||0
74048338|NCT05306964|147649912|OTHER|||||||0.9|||||||GLMM|||||||0.9
74048339|NCT05306964|147649913|OTHER|||||||0|||||||GLMM|||||||0
74048340|NCT05306964|147649914|OTHER|||||||0|||||||GLMM|||||||0
74048341|NCT05306964|147649915|OTHER|||||||0|||||||GLMM|||||||0
74048342|NCT05306964|147649916|OTHER|||||||0.5|||||||GLMM|||||||0.5
74048343|NCT05306964|147649917|OTHER|||||||0.2|||||||GLMM|||||||0.2
74048344|NCT05306964|147649918|OTHER|||||||0.3|||||||GLMM|||||||0.3
74048345|NCT03811535|147649972|NON_INFERIORITY|The pre-specified non-inferiority margin was -1.8 cm/year.|Treatment difference|-0.5|||||TWO_SIDED|95.0|-1.1|0.2|||ANCOVA|||Height velocity at week 52 was analyzed using an analysis of covariance model with treatment, gender, age group, region, growth hormone (GH) peak group and gender by age group by region interaction term as factors, and baseline height as covariate.||0.2|-1.1|
74048346|NCT03811535|147649973|NON_INFERIORITY|The pre-specified non-inferiority margin was -1.8 cm/year.|Treatment difference|-0.5|||||TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||Height velocity at 52 weeks was analyzed using a mixed model for repeated measurements, with treatment, gender, age group, region, GH peak group and gender by age group by region interaction terms as factors and baseline height as a covariate, all nested within week as a factor.||0.2|-1.1|
74048347|NCT06408818|147650053|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.69|TWO_SIDED||||||Regression, Linear|||||||0.69
74048348|NCT06408818|147650054|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.33|TWO_SIDED||||||Regression, Linear|||||||0.33
74048349|NCT06408818|147650055|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.46|TWO_SIDED||||||Regression, Linear|||||||0.46
74048350|NCT06408818|147650056|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.46|TWO_SIDED||||||Regression, Linear|||||||0.46
74048351|NCT06408818|147650057|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
74048352|NCT06408818|147650058|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.22|TWO_SIDED||||||Regression, Linear|||||||0.22
74048353|NCT06408818|147650059|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.19||0.48|TWO_SIDED||||||Regression, Linear|||||||0.48
74048354|NCT06408818|147650060|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.69|TWO_SIDED||||||Regression, Linear|||||||0.69
74048355|NCT06408818|147650061|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.63||0.22|TWO_SIDED||||||Regression, Logistic|||||||0.22
74048356|NCT06408818|147650062|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.79||0.57|TWO_SIDED||||||Regression, Logistic|||||||0.57
74048357|NCT06408818|147650063|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.42|TWO_SIDED||||||Regression, Linear|||||||0.42
74097631|NCT00372411|147744131|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84||||0.03|TWO_SIDED|95.0|-1.62|-0.06||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||-0.06|-1.62|0.03
74097632|NCT00372411|147744132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.95|TWO_SIDED|95.0|-0.25|0.26||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||0.26|-0.25|0.95
74097633|NCT00372411|147744132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.1|TWO_SIDED|95.0|-0.42|0.04||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||0.04|-0.42|0.10
74097634|NCT01284361|147744142|SUPERIORITY_OR_OTHER||Proportion|91.5|||||TWO_SIDED|95.0|84.5|97.5|||||Seventy five of the 82 subjects (91.5%) preferred the longer commercially available catheter over the experimental 30 cm catheter.|The sample size of 81 subjects provides a 10.8% margin of error.||97.5|84.5|
74097635|NCT00324649|147744157|SUPERIORITY_OR_OTHER|||||||0.0014||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0014
74097636|NCT00324649|147744158|SUPERIORITY_OR_OTHER|||||||0.9713||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9713
74097637|NCT00324649|147744159|SUPERIORITY_OR_OTHER|||||||0.9725||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9725
74048358|NCT06408818|147650064|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.45|TWO_SIDED||||||Regression, Linear|||||||0.45
74048359|NCT06408818|147650065|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.39|TWO_SIDED||||||Regression, Linear|||||||0.39
74048360|NCT05492877|147650086|SUPERIORITY||Hazard Ratio (HR)|1.071||||0.599|TWO_SIDED|90.0|0.869|1.32|||Regression, Cox||||The p-value was based on a 2-sided log rank test stratified by region|1.320|0.869|0.599
74048361|NCT05492877|147650089|SUPERIORITY||Hazard Ratio (HR)|1.234|||||TWO_SIDED|90.0|0.882|1.726|||Regression, Cox|||||1.726|0.882|
74048362|NCT01426009|147650110|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0723|STANDARD_ERROR_OF_MEAN|0.0188||0.0003|TWO_SIDED|95.0|0.0347|0.1099|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence. A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1099|0.0347|0.0003
74048363|NCT01426009|147650110|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0676|STANDARD_ERROR_OF_MEAN|0.0184||0.0006|TWO_SIDED|95.0|0.0307|0.1046|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1046|0.0307|0.0006
74048364|NCT01426009|147650110|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.1021|STANDARD_ERROR_OF_MEAN|0.0188|<|0.0001|TWO_SIDED|95.0|0.0644|0.1398|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1398|0.0644|<0.0001
74097638|NCT00324649|147744160|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0078
74097639|NCT00324649|147744161|SUPERIORITY_OR_OTHER|||||||0.6984||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: percentages of days with compliance in the two treatment groups are equal. Alternative Hypothesis: percentages of days with compliance in the two treatment groups are different (two sided).||||0.6984
74048365|NCT01426009|147650110|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.1299|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0918|0.1681|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||00.1681|0.0918|<0.0001
74048366|NCT01426009|147650110|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0446|STANDARD_ERROR_OF_MEAN|0.0186||0.02|TWO_SIDED|95.0|0.0073|0.082|||Mantel Haenszel||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0820|0.0073|0.0200
74048367|NCT01426009|147650110|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0813|STANDARD_ERROR_OF_MEAN|0.0284||0.006|TWO_SIDED|95.0|0.0243|0.1382|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1382|0.0243|0.0060
74048368|NCT01426009|147650110|SUPERIORITY|Day 1 analysis|Least Squares Mean Difference (SE)|0.0385|STANDARD_ERROR_OF_MEAN|0.0183||0.0402|TWO_SIDED|95.0|0.0018|0.0752|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0752|0.0018|0.0402
74048369|NCT01426009|147650110|SUPERIORITY|Day 1 analysis|Least Squares Mean Difference (SE)|0.0696|STANDARD_ERROR_OF_MEAN|0.0179||0.0003|TWO_SIDED|95.0|0.0337|0.1055|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1055|0.0337|0.0003
73880915|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8504|TWO_SIDED|95.0|0.39|3.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.12|0.39|0.8504
73880916|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0759|TWO_SIDED|95.0|0.89|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.61|0.89|0.0759
74048370|NCT01426009|147650110|SUPERIORITY|Day 1 analysis|Least Squares Mean|0.0501|STANDARD_ERROR_OF_MEAN|0.018||0.0074|TWO_SIDED|95.0|0.014|0.0861|||ANCOVA|||An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0861|0.0140|0.0074
74048371|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.0767|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.0505|0.1028|||ANCOVA||standard error of the mean difference|ACU 0-24 on Day 1||0.1028|0.0505|<0.0001
74048372|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.122|STANDARD_ERROR_OF_MEAN|0.0127|<|0.0001|TWO_SIDED|95.0|0.0965|0.1475|||ANCOVA||standard error of the Mean difference|ACU 0-24 Day 1||0.1475|0.0965|<0.0001
74048373|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1222|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.0965|0.1479|||ANCOVA||standard error of the Mean difference|AUC 0-24 Day 1||0.1479|0.0965|<0.0001
74097640|NCT00324649|147744162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.3||||0.1165||95.0|-0.9|29.4||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.|The difference is for Truvada minus zidovudine/lamivudine. The 95% confidence interval on the mean difference between treatment groups is based on the normal approximation.|"Null Hypothesis: treatment is not associated with the observed virologic response.~Alternative Hypothesis: treatment is associated with the observed virologic response."||29.4|-0.9|0.1165
73888100|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|27.7||||0.0185|TWO_SIDED|95.0|4.7|50.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||50.6|4.7|0.0185
74048374|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1625|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.1362|0.1888|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1888|0.1362|<0.0001
74048375|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.169|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1434|0.1946|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1946|0.1434|<0.0001
74097641|NCT00324649|147744165|SUPERIORITY_OR_OTHER|||||||0.0789||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0789
74097642|NCT00324649|147744166|SUPERIORITY_OR_OTHER|||||||0.9633||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9633
74097643|NCT00324649|147744167|SUPERIORITY_OR_OTHER|||||||0.9686||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9686
73880917|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0477|TWO_SIDED|95.0|1.01|13.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.46|1.01|0.0477
74097644|NCT00324649|147744168|SUPERIORITY_OR_OTHER|||||||0.6638||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.6638
74097645|NCT00324649|147744169|SUPERIORITY_OR_OTHER|||||||0.2907||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.2907
74097646|NCT00324649|147744170|SUPERIORITY_OR_OTHER|||||||0.0072||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0072
74097647|NCT00324649|147744171|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0006
74048376|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1095|STANDARD_ERROR_OF_MEAN|0.0189|<|0.0001|TWO_SIDED|95.0|0.0716|0.1473|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1473|0.0716|<0.0001
74048377|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1095|STANDARD_ERROR_OF_MEAN|0.0141|<|0.0001|TWO_SIDED|95.0|0.0812|0.1379|||ANCOVA||standard error of the Mean difference|AUC 0-24 on Day 7||0.1379|0.0812|<0.0001
74048378|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1271|STANDARD_ERROR_OF_MEAN|0.0139|<|0.0001|TWO_SIDED|95.0|0.0993|0.1548|||ANCOVA||standard error of the Mean difference|AUC0-24 on Day 7||0.1548|0.0993|<0.0001
74048379|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.145|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.1169|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1730|0.1169|<0.0001
74048380|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1688|STANDARD_ERROR_OF_MEAN|0.0142|<|0.0001|TWO_SIDED|95.0|0.1403|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1972|0.1403|<0.0001
74097648|NCT00324649|147744172|SUPERIORITY_OR_OTHER|||||||0.1785||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.1785
74097649|NCT01988129|147744185|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||Analysis for 'sick' days||||0.66
74097650|NCT01988129|147744185|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||t-test, 2 sided|||Analysis for 'disability/injury' days||||0.033
73880918|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.47||||0.1448|TWO_SIDED|95.0|0.73|8.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.36|0.73|0.1448
74048381|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1396|STANDARD_ERROR_OF_MEAN|0.0139|<|0.0001|TWO_SIDED|95.0|0.1117|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1730|0.1117|<0.0001
74097651|NCT01988129|147744185|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|Mixed model analysis with nested random effects for possible station-level and station-pairing correlation (3-level hierarchical linear model)||Mixed model analysis was conducted for 'disability/injury' days||||0.003
74048382|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1183|STANDARD_ERROR_OF_MEAN|0.0194|<|0.0001|TWO_SIDED|95.0|0.0795|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1972|0.0795|<0.0001
74048383|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1038|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.0776|0.1301|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1301|0.0776|<0.0001
74048384|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1468|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1212|0.1724|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1724|0.1212|<0.0001
74048385|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1579|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1322|0.1837|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1837|0.1322|<0.0001
74048386|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1919|STANDARD_ERROR_OF_MEAN|0.0132|<|0.0001|TWO_SIDED|95.0|0.1655|0.2184|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.2184|0.1655|<0.0001
74097652|NCT01988129|147744186|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
74097653|NCT01988129|147744187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.31|TWO_SIDED|95.0|0.6|0.98|||t-test, 2 sided||The Odds Ratio analyses compared the odds of reporting at least one injury during the study between those who did (n=560) and did not (n=629) attend the education sessions, regardless of station assignment (intervention or control).|||0.98|0.60|0.31
73880919|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|5.54||||0.0173|TWO_SIDED|95.0|1.35|22.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||22.71|1.35|0.0173
74048387|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1994|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1738|0.2251|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.2251|0.1738|<0.0001
74048388|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1248|STANDARD_ERROR_OF_MEAN|0.0188|<|0.0001|TWO_SIDED|95.0|0.0872|0.1625|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1625|0.0872|<0.0001
74048389|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1279|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.097|0.1587|||ANCOVA|standard error of the Mean difference|standard error of the Mean difference|AUC 0-12 on day 7||0.1587|0.0970|<0.0001
74048390|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1454|STANDARD_ERROR_OF_MEAN|0.0151|<|0.0001|TWO_SIDED|95.0|0.1151|0.1756|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.1756|0.1151|<0.0001
74048391|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1699|STANDARD_ERROR_OF_MEAN|0.0152|<|0.0001|TWO_SIDED|95.0|0.1393|0.2004|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.2004|0.1393|<0.0001
74048392|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1814|STANDARD_ERROR_OF_MEAN|0.0155|<|0.0001|TWO_SIDED|95.0|0.1503|0.2125|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.2125|0.1503|<0.0001
74048393|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1697|STANDARD_ERROR_OF_MEAN|0.0152|<|0.0001|TWO_SIDED|95.0|0.1393|0.201|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.201|0.1393|<0.0001
74048394|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1384|STANDARD_ERROR_OF_MEAN|0.0216|<|0.0001|TWO_SIDED|95.0|0.0951|0.1817|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.1817|0.0951|<0.0001
74048395|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.0471|STANDARD_ERROR_OF_MEAN|0.0157|<|0.0001|TWO_SIDED|95.0|0.0155|0.0786|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.0786|0.0155|<0.0001
74048396|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.0918|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.0611|0.1226|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1226|0.0611|<0.0001
74048397|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.0829|STANDARD_ERROR_OF_MEAN|0.0155|<|0.0001|TWO_SIDED|95.0|0.0519|0.1139|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1139|0.0519|<0.0001
73880920|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.57||||0.1101|TWO_SIDED|95.0|0.81|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.17|0.81|0.1101
74048398|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1299|STANDARD_ERROR_OF_MEAN|0.0158|<|0.0001|TWO_SIDED|95.0|0.0982|0.1617|||ANCOVA||standard error of the Mean difference|AUC 12-24 o day 1||0.1617|0.0982|<0.0001
74048399|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1369|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.1061|0.1678|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1678|0.1061|<0.0001
74048400|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.0934|STANDARD_ERROR_OF_MEAN|0.0221|<|0.0001|TWO_SIDED|95.0|0.049|0.1377|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1377|0.0490|<0.0001
74048401|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.0879|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.0573|0.1186|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1186|0.0573|<0.0001
74048402|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1088|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.0788|0.1388|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1388|0.0788|<0.0001
74048403|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1175|STANDARD_ERROR_OF_MEAN|0.0151|<|0.0001|TWO_SIDED|95.0|0.0872|0.1478|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1478|0.0872|<0.0001
74048404|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1532|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.1226|0.1838|||ANCOVA||standard error of the Mean difference|||0.1838|0.1226|<0.0001
74048405|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.1048|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.0747|0.135|||ANCOVA||standard error of the Mean difference|||0.1350|0.0747|<0.0001
74048406|NCT01426009|147650111|SUPERIORITY||Least Squares Mean Difference (SE)|0.0993|STANDARD_ERROR_OF_MEAN|0.0202|<|0.0001|TWO_SIDED|95.0|0.0589|0.1398|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1398|0.0589|<0.0001
74048407|NCT00515099|147650160|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.60
74048408|NCT00515099|147650161|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||Missing Month 12 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL||||0.40
74048409|NCT00515099|147650162|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 12||||0.59
74048410|NCT00515099|147650162|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 24||||0.14
74048411|NCT00515099|147650164|SUPERIORITY_OR_OTHER||||||>|0.099|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 12||||>0.099
74097654|NCT01988129|147744188|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Paired t-test|||Of the 100 participants who completed both the pre- and post-study survey (see Patient Flow), only 62 completed answered the question about sleep duration at both time points||||0.22
74097655|NCT01988129|147744189|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||paired t-test|||||||0.65
74097656|NCT01988129|147744190|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||paired t-test|||||||0.71
74097657|NCT01988129|147744192|SUPERIORITY_OR_OTHER||Percentage of firefighters screened|41.5|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of any sleep disorders; there is no comparison group||||
74097658|NCT01988129|147744192|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|31.3|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of obstructive sleep apnea only; there is no comparison group||||
74097659|NCT01988129|147744192|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|7.7|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of insomnia; there is no comparison group||||
74097660|NCT01988129|147744192|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|3.5|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of restless legs syndrome only; there is no comparison group||||
74097661|NCT01988129|147744192|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|9.3|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of shiftwork disorder only; there is no comparison group||||
74097662|NCT01988129|147744193|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||paired t-test|||||||0.31
74097663|NCT01988129|147744194|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Paired t-test, 2-sided|||Sleeping while stopped in traffic||||0.16
74097664|NCT01988129|147744195|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Paired t-test, 2-sided|||||||0.46
73880921|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6022|TWO_SIDED|95.0|0.46|3.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.78|0.46|0.6022
74048412|NCT00515099|147650164|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 24||||0.75
74048413|NCT00515099|147650165|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||2-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Primary imputation method used for missing Month 24 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.38
74048414|NCT00515099|147650165|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||4-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Missing Month 24 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.33
74048415|NCT00515099|147650166|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 12||||0.07
74048416|NCT00515099|147650166|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 24||||0.16
74048417|NCT04476108|147650167|SUPERIORITY||Posterior Mean Difference|-0.42|||||TWO_SIDED|95.0|-1.17|0.32|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.32|-1.17|
74097665|NCT02740699|147744197|SUPERIORITY|||||||0.0256|||||||Wilcoxon Signed Rank Tests|||||||0.0256
74097666|NCT02740699|147744198|SUPERIORITY|||||||0.0254|||||||Wilcoxon Signed Rank Tests|||||||0.0254
74097667|NCT02740699|147744199|SUPERIORITY|||||||0.58|||||||Regression, Linear|||||||0.58
74097668|NCT02740699|147744200|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
74097669|NCT02740699|147744201|SUPERIORITY|||||||0.69|||||||Regression, Linear|||||||0.69
74097670|NCT02740699|147744202|SUPERIORITY|||||||0.006|||||||Regression, Linear|||||||0.006
74097671|NCT04713553|147744203|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% confidence interval (CI) for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|1.01|||||TWO_SIDED|95.0|0.91|1.13|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.13|0.91|
74097672|NCT04713553|147744203|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.04|0.83|
74097673|NCT04713553|147744203|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.92|||||TWO_SIDED|95.0|0.82|1.03|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.03|0.82|
74097674|NCT04713553|147744204|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.95|||||TWO_SIDED|95.0|0.84|1.07|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.07|0.84|
74097675|NCT04713553|147744205|NON_INFERIORITY|Noninferiority of the 20 mcg dose to the corresponding 30 mcg dose was said to be achieved if the lower limit of the 2-sided 95% CI for the GMR is \>0.67.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.02|||||GMRs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group|||1.02|0.84|
74048418|NCT04476108|147650168|SUPERIORITY||Posterior Mean Difference|-0.37|||||TWO_SIDED|95.0|-1.09|0.35|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.35|-1.09|
74048419|NCT04476108|147650169|SUPERIORITY||Posterior Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.69|0.15|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.15|-0.69|
74048420|NCT04476108|147650170|SUPERIORITY||Posterior Mean Difference|-0.44|||||TWO_SIDED|95.0|-1.2|0.31|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.31|-1.20|
74048421|NCT04476108|147650171|SUPERIORITY||Posterior Mean Difference|-2.86|||||TWO_SIDED|95.0|-11.71|6.06|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||6.06|-11.71|
74048422|NCT04476108|147650172|SUPERIORITY||Posterior Mean Difference|0.35|||||TWO_SIDED|95.0|-0.09|0.78|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.78|-0.09|
74048423|NCT04476108|147650173|SUPERIORITY||Posterior Mean Difference|0.34|||||TWO_SIDED|95.0|-188.46|187.97|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||187.97|-188.46|
74048424|NCT04476108|147650174|SUPERIORITY||Posterior Mean Difference|0.04|||||TWO_SIDED|95.0|-0.01|0.1|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.10|-0.01|
74048425|NCT03676465|147650175|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
74048426|NCT03676465|147650176|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
74048427|NCT03676465|147650177|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
74048428|NCT03676465|147650178|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
74048429|NCT03676465|147650179|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
74048430|NCT03676465|147650180|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
74048431|NCT03676465|147650181|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
74048432|NCT03676465|147650182|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
74048433|NCT03676465|147650183|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
74048434|NCT03676465|147650184|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
74048435|NCT03676465|147650185|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
74048436|NCT03676465|147650186|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
74048437|NCT03676465|147650187|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
74048438|NCT03676465|147650188|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74048439|NCT03685643|147650189|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74048440|NCT03685643|147650190|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
74048441|NCT03685643|147650191|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
74048442|NCT04716010|147650217|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.002
74048443|NCT04716010|147650217|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
74048444|NCT04716010|147650217|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
74048445|NCT04716010|147650217|SUPERIORITY|||||||0.024||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.024
74048446|NCT04716010|147650217|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
74048447|NCT04716010|147650217|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
74048448|NCT04716010|147650218|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.001
74048449|NCT04716010|147650218|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
74048450|NCT04716010|147650218|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
74048451|NCT04716010|147650218|SUPERIORITY|||||||0.022||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.022
74048452|NCT04716010|147650218|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
74048453|NCT04716010|147650218|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
74048454|NCT04716010|147650219|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \>0.05|Regression, Linear|||||||>0.05
74048455|NCT04716010|147650219|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048456|NCT04716010|147650219|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
73880922|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6128|TWO_SIDED|95.0|0.46|3.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.73|0.46|0.6128
74048457|NCT04716010|147650219|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048458|NCT04716010|147650219|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048459|NCT04716010|147650219|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
73880923|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.82||||0.1001|TWO_SIDED|95.0|0.82|9.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.68|0.82|0.1001
73880924|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.95||||0.0255|TWO_SIDED|95.0|1.22|20.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.12|1.22|0.0255
73880925|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.42||||0.1521|TWO_SIDED|95.0|0.72|8.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.10|0.72|0.1521
74048460|NCT04716010|147650220|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74097676|NCT01853930|147744258|SUPERIORITY|The purpose of the superiority test is to show if laboratory based training is superior to an independent home-based training option.||||||0.876|||||||t-test, 2 sided|t= -0.157 df= 30||||||0.876
74097677|NCT00537303|147744288|NON_INFERIORITY_OR_EQUIVALENCE|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the full analysis set and the per protocol set|Mean Difference (Final Values)|0.06||||0.606||95.0|-0.17|0.29||P-value for test of difference between treatments.|ANCOVA|Regimen, country and previous oral antidiabetic drug (OAD) use as factors and baseline HbA1c as covariate.||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.||0.29|-0.17|0.606
73880926|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|9.37||||0.0071|TWO_SIDED|95.0|1.84|47.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||47.69|1.84|0.0071
73880927|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.52||||0.115|TWO_SIDED|95.0|0.8|7.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.93|0.80|0.1150
73880928|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8101|TWO_SIDED|95.0|0.4|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.22|0.40|0.8101
73880929|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.49||||0.4663|TWO_SIDED|95.0|0.51|4.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.33|0.51|0.4663
73880930|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0453|TWO_SIDED|95.0|1.03|14.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.01|1.03|0.0453
73880931|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0659|TWO_SIDED|95.0|0.92|12.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.21|0.92|0.0659
73880932|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.83||||0.3117|TWO_SIDED|95.0|0.57|5.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.86|0.57|0.3117
74048461|NCT04716010|147650220|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048462|NCT04716010|147650220|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048463|NCT04716010|147650220|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048464|NCT04716010|147650220|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048465|NCT04716010|147650220|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048466|NCT04716010|147650221|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048467|NCT04716010|147650221|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048468|NCT04716010|147650221|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048469|NCT04716010|147650221|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048470|NCT04716010|147650221|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048471|NCT04716010|147650221|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048472|NCT04716010|147650222|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048473|NCT04716010|147650222|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048474|NCT04716010|147650222|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048475|NCT04716010|147650222|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048476|NCT04716010|147650222|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048477|NCT04716010|147650222|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
74048478|NCT04716010|147650223|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048479|NCT04716010|147650223|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
73880933|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|6.02||||0.0129|TWO_SIDED|95.0|1.46|24.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||24.73|1.46|0.0129
73880934|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0303|TWO_SIDED|95.0|1.14|14.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.83|1.14|0.0303
74048480|NCT04716010|147650223|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048481|NCT04716010|147650223|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048482|NCT04716010|147650223|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048483|NCT04716010|147650223|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048484|NCT04716010|147650224|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048485|NCT04716010|147650224|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048486|NCT04716010|147650224|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048487|NCT04716010|147650224|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048488|NCT04716010|147650224|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048489|NCT04716010|147650224|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048490|NCT04716010|147650225|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048491|NCT04716010|147650225|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048492|NCT04716010|147650225|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048493|NCT04716010|147650225|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048494|NCT04716010|147650225|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048495|NCT04716010|147650225|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048496|NCT04716010|147650226|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048497|NCT04716010|147650226|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048498|NCT04716010|147650226|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048499|NCT04716010|147650226|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048500|NCT04716010|147650226|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048501|NCT04716010|147650226|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048502|NCT04716010|147650227|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048503|NCT04716010|147650227|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048504|NCT04716010|147650227|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048505|NCT04716010|147650227|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048506|NCT04716010|147650227|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048507|NCT04716010|147650227|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048508|NCT04716010|147650228|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048509|NCT04716010|147650228|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048510|NCT04716010|147650228|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
73880935|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.94||||0.2772|TWO_SIDED|95.0|0.59|6.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.42|0.59|0.2772
73880936|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9432|TWO_SIDED|95.0|0.29|3.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.16|0.29|0.9432
73880937|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.08||||0.2577|TWO_SIDED|95.0|0.59|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.36|0.59|0.2577
74048511|NCT04716010|147650228|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048512|NCT04716010|147650228|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048513|NCT04716010|147650228|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048514|NCT04716010|147650229|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048515|NCT04716010|147650229|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048516|NCT04716010|147650229|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048517|NCT04716010|147650229|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
73880938|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1496|TWO_SIDED|95.0|0.71|9.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.12|0.71|0.1496
73880939|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.05||||0.2874|TWO_SIDED|95.0|0.55|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.67|0.55|0.2874
73880940|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1981|TWO_SIDED|95.0|0.65|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.78|0.65|0.1981
73880941|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|3.35||||0.0531|TWO_SIDED|95.0|0.98|11.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.43|0.98|0.0531
73888101|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.5471|TWO_SIDED|95.0|-15.8|29.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.7|-15.8|0.5471
74048518|NCT04716010|147650229|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74097678|NCT00537303|147744289|NON_INFERIORITY_OR_EQUIVALENCE|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the Full Analysis Set and the Per Protocol set.|Mean Difference (Final Values)|0.03||||0.816||95.0|-0.21|0.26||P-value for test of difference between treatments.|ANCOVA|||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.||0.26|-0.21|0.816
74048519|NCT04716010|147650229|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048520|NCT04716010|147650230|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048521|NCT04716010|147650230|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048522|NCT04716010|147650230|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048523|NCT04716010|147650230|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048524|NCT04716010|147650230|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048525|NCT04716010|147650230|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048526|NCT04716010|147650231|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048527|NCT04716010|147650231|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048528|NCT04716010|147650231|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048529|NCT04716010|147650231|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048530|NCT04716010|147650231|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048531|NCT04716010|147650231|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048532|NCT04716010|147650232|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048533|NCT04716010|147650232|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048534|NCT04716010|147650232|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74097679|NCT03839823|147744310|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.003|TWO_SIDED|95.0|0.429|0.87|||one-sided stratified logrank test|||||0.870|0.429|0.003
74097680|NCT03839823|147744311|SUPERIORITY||Hazard Ratio (HR)|0.497||||||95.0|0.363|0.68||||||||0.680|0.363|
74097681|NCT03839823|147744312|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
74097682|NCT03839823|147744313|SUPERIORITY|||||||0.255|||||||Cochran-Mantel-Haenszel|||||||0.255
74097683|NCT03839823|147744314|SUPERIORITY|||||||0.116|||||||Cochran-Mantel-Haenszel|||||||0.116
74097684|NCT03839823|147744315|SUPERIORITY||Hazard Ratio (HR)|0.762|||||TWO_SIDED|95.0|0.546|1.064||||||||1.064|0.546|
74097685|NCT03151811|147744328|SUPERIORITY|||||||0.0311|||||||Log Rank|||||||0.0311
74097686|NCT01243112|147744335|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||ANOVA|||Null Hypothesis is that no difference would be measured between treatment arms.||||0.359
74097687|NCT01243112|147744336|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANOVA|||||||0.490
74097688|NCT01081834|147744337|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.091|<|0.001|TWO_SIDED|95.0|-1.088|-0.729|||ANCOVA|||||-0.729|-1.088|<0.001
73880942|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5858|TWO_SIDED|95.0|0.22|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.35|0.22|0.5858
74097689|NCT01081834|147744337|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.091|<|0.001|TWO_SIDED|95.0|-1.342|-0.985|||ANCOVA|||||-0.985|-1.342|<0.001
73880943|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.68||||0.5122|TWO_SIDED|95.0|0.21|2.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.16|0.21|0.5122
74097690|NCT01081834|147744339|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.34|||<|0.001|TWO_SIDED|95.0|3.1|9.23|||Regression, Logistic|||||9.23|3.10|<0.001
74097691|NCT01081834|147744339|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.61|||<|0.001|TWO_SIDED|95.0|8.14|26.25|||Regression, Logistic|||||26.25|8.14|<0.001
73880944|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.55||||0.3415|TWO_SIDED|95.0|0.16|1.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.89|0.16|0.3415
74097692|NCT01081834|147744340|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-35.5|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-42.22|-28.78|||ANCOVA|||||-28.78|-42.22|<0.001
74097693|NCT01081834|147744340|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-43.4|STANDARD_ERROR_OF_MEAN|3.402|<|0.001|TWO_SIDED|95.0|-50.06|-36.69|||ANCOVA|||||-36.69|-50.06|<0.001
74097694|NCT01081834|147744341|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-49.1|STANDARD_ERROR_OF_MEAN|5.629|<|0.001|TWO_SIDED|95.0|-59.12|-36.99|||ANCOVA|||||-36.99|-59.12|<0.001
74097695|NCT01081834|147744341|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-64.0|STANDARD_ERROR_OF_MEAN|5.616|<|0.001|TWO_SIDED|95.0|-75.02|-52.94|||ANCOVA|||||-52.94|-75.02|<0.001
74097696|NCT01081834|147744342|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.9|-1.6|||ANCOVA|||||-1.6|-2.9|<0.001
74097697|NCT01081834|147744342|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-4.0|-2.6|||ANCOVA|||||-2.6|-4.0|<0.001
74097698|NCT01081834|147744343|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.71|STANDARD_ERROR_OF_MEAN|1.093|<|0.001|TWO_SIDED|95.0|-5.86|-1.568|||ANCOVA|||||-1.568|-5.860|<0.001
74097699|NCT01081834|147744343|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.42|STANDARD_ERROR_OF_MEAN|1.088|<|0.001|TWO_SIDED|95.0|-7.556|-3.28|||ANCOVA|||||-3.280|-7.556|<0.001
74097700|NCT01081834|147744344|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|4.8||0.267|TWO_SIDED|95.0|-14.8|4.1|||ANCOVA|||||4.1|-14.8|0.267
74097701|NCT01081834|147744344|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|4.8||0.034|TWO_SIDED|95.0|-19.6|-0.8|||ANCOVA|||||-0.8|-19.6|0.034
74097702|NCT01081834|147744345|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|2.9|10.6|||ANCOVA|||||10.6|2.9|<0.001
74097703|NCT01081834|147744345|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.9||0.002|TWO_SIDED|95.0|2.2|9.9|||ANCOVA|||||9.9|2.2|0.002
74097704|NCT03149445|147744366|SUPERIORITY||LS Mean Difference|-5.4||||0.1045|TWO_SIDED|95.0|-12.3|1.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||1.5|-12.3|0.1045
74097705|NCT03149445|147744366|SUPERIORITY||LS Mean Difference|0.7||||0.7422|TWO_SIDED|95.0|-4.0|5.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||5.3|-4.0|0.7422
74097706|NCT03149445|147744366|SUPERIORITY||LS Mean Difference|5.6||||0.046|TWO_SIDED|95.0|0.1|11.0||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||11.0|0.1|0.0460
74097707|NCT03149445|147744366|SUPERIORITY||LS Mean Difference|4.3||||0.3847|TWO_SIDED|95.0|-9.2|17.8||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||17.8|-9.2|0.3847
74097708|NCT03149445|147744367|SUPERIORITY||LS Mean Difference|-6.2||||0.1326|TWO_SIDED|95.0|-14.9|2.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||2.5|-14.9|0.1326
74097709|NCT03149445|147744367|SUPERIORITY||LS Mean Difference|1.2||||0.5148|TWO_SIDED|95.0|-2.9|5.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||5.3|-2.9|0.5148
74097710|NCT03149445|147744367|SUPERIORITY||LS Mean Difference|4.5||||0.0605|TWO_SIDED|95.0|-0.3|9.4||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||9.4|-0.3|0.0605
74097711|NCT03149445|147744367|SUPERIORITY||LS Mean Difference|2.6||||0.5198|TWO_SIDED|95.0|-8.8|14.0||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||14.0|-8.8|0.5198
74018760|NCT00254566|147589652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.385||95.0|-0.27|0.1|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.10|-0.27|0.385
74018761|NCT00254566|147589652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.56||95.0|-0.17|0.09|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.09|-0.17|0.56
74018762|NCT00254566|147589653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.62||95.0|-0.26|0.16|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.16|-0.26|0.62
74018763|NCT00254566|147589653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8||95.0|-0.18|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.14|-0.18|0.80
74018764|NCT03106779|147589694|SUPERIORITY||treatment difference in the MMR rate|12.2||||0.029|TWO_SIDED|95.0|2.19|22.3|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factor, i.e. cytogenetic response status (MCyR vs no MCyR) at screening||||22.30|2.19|0.029
74018765|NCT02288247|147589709|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.027|TWO_SIDED|95.0|0.53|0.96||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||0.96|0.53|0.027
74018766|NCT02288247|147589710|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.002|TWO_SIDED|95.0|0.41|0.82||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||0.82|0.41|0.002
74018767|NCT02288247|147589712|SUPERIORITY|||||||0.142||||||From the Cochran-Mantel-Haenszel test stratified by disease progression (radiographic, non-radiographic) in Period 1.|Cochran-Mantel-Haenszel|||||||0.142
74018768|NCT02288247|147589715|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.994|TWO_SIDED|95.0|0.47|2.13||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||2.13|0.47|0.994
74018769|NCT04652804|147589718|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|1.0|1.19||||||Reference group: Low Intensity Intervention||1.19|1.00|
74018770|NCT04652804|147589718|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.9|1.05||||||Reference Group: Low Intensity Intervention||1.05|0.90|
74018771|NCT04652804|147589718|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.8|1.15||||||Reference group: High Intensity Intervention||1.15|0.80|
74018772|NCT04652804|147589718|SUPERIORITY||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.77|1.04||||||Reference group: High Intensity Intervention||1.04|0.77|
74018773|NCT00356031|147589817|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<.05
74018774|NCT00356031|147589818|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<.05
74018775|NCT02623335|147589852|SUPERIORITY||Odds Ratio (OR)|1.32||||0.353|TWO_SIDED||||||Mixed Models Analysis|||Options questions||||0.353
74018776|NCT02623335|147589852|SUPERIORITY||Odds Ratio (OR)|0.97||||0.923|TWO_SIDED||||||Mixed Models Analysis|||Expectations questions||||0.923
74018777|NCT02623335|147589852|SUPERIORITY||Odds Ratio (OR)|1.41||||0.255|TWO_SIDED||||||Mixed Models Analysis|||Risks questions||||0.255
74018778|NCT02623335|147589852|SUPERIORITY||Odds Ratio (OR)|239047259.0||||0.094|TWO_SIDED||||||Mixed Models Analysis|||Advance directives questions||||0.094
74018779|NCT02623335|147589853|SUPERIORITY||Effect estimate|-0.04||||0.84|TWO_SIDED||||||Mixed Models Analysis|||Change in scores between T2 and T1||||0.84
74018780|NCT02623335|147589853|SUPERIORITY||Effect estimate|-0.15||||0.645|TWO_SIDED||||||Mixed Models Analysis|||Change in scores between T3 and T1||||0.645
74018781|NCT02623335|147589854|SUPERIORITY||Effect estimate|-0.37||||0.411|TWO_SIDED||||||Mixed Models Analysis|||||||0.411
74018782|NCT02623335|147589855|SUPERIORITY||Odds Ratio (OR)|1.39||||0.412|TWO_SIDED||||||Mixed Models Analysis|||||||0.412
74018783|NCT02623335|147589856|SUPERIORITY||Effect estimate|-0.25||||0.009|TWO_SIDED||||||Mixed Models Analysis|||||||0.009
74018784|NCT02623335|147589857|SUPERIORITY||Effect estimate|-0.72||||0.106|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.106
74018785|NCT02623335|147589857|SUPERIORITY||Effect estimate|-1.12||||0.007|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)||||0.007
74018786|NCT02623335|147589858|SUPERIORITY||Effect estimate|0.97||||0.034|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.034
74018787|NCT02623335|147589858|SUPERIORITY||Effect estimate|1.12||||0.019|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment (T3)||||0.019
74018788|NCT02623335|147589859|SUPERIORITY||Effect estimate|1.16||||0.022|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.022
74018789|NCT02623335|147589859|SUPERIORITY||Effect estimate|0.94||||0.053|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)||||0.053
74018790|NCT02623335|147589861|SUPERIORITY||Effect estimate|5.04||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
74048535|NCT04716010|147650232|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048536|NCT04716010|147650232|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048537|NCT04716010|147650232|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048538|NCT04716010|147650233|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048539|NCT04716010|147650233|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048540|NCT04716010|147650233|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048541|NCT04716010|147650233|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048542|NCT04716010|147650233|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048543|NCT04716010|147650233|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048544|NCT04716010|147650234|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74097712|NCT03149445|147744368|SUPERIORITY||LS Mean Difference|-8.1||||0.0058|TWO_SIDED|95.0|-12.5|-3.6||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||-3.6|-12.5|0.0058
74048545|NCT04716010|147650234|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048546|NCT04716010|147650234|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048547|NCT04716010|147650234|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048548|NCT04716010|147650234|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048549|NCT04716010|147650234|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048550|NCT04716010|147650235|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048551|NCT04716010|147650235|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048552|NCT04716010|147650235|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048553|NCT04716010|147650235|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74097713|NCT03149445|147744368|SUPERIORITY||LS Mean Difference|2.1||||0.5142|TWO_SIDED|95.0|-5.3|9.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||9.5|-5.3|0.5142
74048554|NCT04716010|147650235|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048555|NCT04716010|147650235|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048556|NCT04716010|147650236|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048557|NCT04716010|147650236|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048558|NCT04716010|147650236|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048559|NCT04716010|147650236|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048560|NCT04716010|147650236|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
74048561|NCT04716010|147650236|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
74048562|NCT00572728|147650239|SUPERIORITY_OR_OTHER||AUC|0.68|STANDARD_ERROR_OF_MEAN|0.1||0.046|ONE_SIDED|95.0||0.83||The Delong method was used to test if the observed AUC was significantly different than 0.5 with the one-sided p value DeLong ER, DeLong DM, Clarke-Pearson DL, Biometrics (1988)|Delong method|one-sided p-value|"percent change in SUVmax was computed as: %ΔSUVmax = 100\*(FLT1-FLT2)/FLT1 a 90% 2-sided confidence interval was constructed from 2000 Bootstrapping estimates from which the 1-sided 95% CI was derived.~Hanley SE(AUC) reported."|"A receiver operating characteristic (ROC) analysis was performed to assess the significance of the Area Under the Curve (AUC) under the Null Hypothesis with a one sided alpha=0.05 (95% one-sided CL):~H0: AUC = 0.50 (no difference from guessing) given the alternative hypothesis: Ha:AUC \>= 0.75 AUC = ROC(%ΔSUVmax\| path response) where percent change (%ΔSUVmax ) was defined as (SUVmax at FLT1 -SUVmax at FLT2)/SUVmax at FLT1 x 100"||.83||0.046
74048563|NCT00572728|147650240|SUPERIORITY_OR_OTHER||spearman correlation|0.35||||0.002|TWO_SIDED|95.0|0.13|0.54|||spearman correlation method||This estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-1 and Ki-67 LI a Fisher's z Transformation was applied to adjust for bias in the Spearman Correlation Statistic||0.54|0.13|0.002
74048564|NCT00572728|147650241|SUPERIORITY_OR_OTHER||Spearman Correlation|0.67|||<|0.0001|TWO_SIDED|95.0|0.47|0.81|||Spearman Correlation method|we use Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|this estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-3 and Ki-67 LI||0.81|0.47|<0.0001
74097714|NCT03149445|147744368|SUPERIORITY||LS Mean Difference|3.1||||0.3794|TWO_SIDED|95.0|-5.1|11.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||11.3|-5.1|0.3794
74097715|NCT03149445|147744368|SUPERIORITY||LS Mean Difference|1.0||||0.685|TWO_SIDED|95.0|-6.1|8.1||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||8.1|-6.1|0.6850
74097716|NCT01442688|147744403|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.995|1.04|||ANOVA|||||1.04|0.995|
73880945|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.87||||0.8263|TWO_SIDED|95.0|0.25|2.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.98|0.25|0.8263
73880946|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8085|TWO_SIDED|95.0|0.24|3.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.03|0.24|0.8085
73880947|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6745|TWO_SIDED|95.0|0.38|4.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.43|0.38|0.6745
74048565|NCT00572728|147650242|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided exact p value from Wilcoxon two-sample test||"H0: Mean SUVmax (RCB 0,I) = Mean SUVmax (RCB II,III) After dichotomization, Wilcoxon two-sample test was used to compare uptake values between RCB groups.~In other words, we are comparing the means (of SUVmax) @ FLT1 between the RCB 0,I and the RCB II,III groups.."||||0.66
74048566|NCT00572728|147650243|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|\*two-sided exact p value from Wilcoxon two-sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT2 between the RCB 0,I and the RCB II,III groups.||||0.86
74048567|NCT00572728|147650244|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided exact p value from Wilcoxon two-sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT3 between the RCB 0,I and the RCB II,III groups.||||0.010
74048568|NCT00572728|147650244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.013|TWO_SIDED|95.0|0.76|0.97|||Regression, Logistic|||H0: %SUVmax FLT1-FLT3 (RCB 0,I) = %SUVmax FLT1-FLT3 (RCB II,III) A logistic regression model is used to determine if a larger percent change in SUVmax is associated with (RCB 0,I); the null hypothesis assumes that there is no association.||0.97|0.76|0.013
74048569|NCT00572728|147650245|SUPERIORITY_OR_OTHER||AUC|0.83|||<|0.001|TWO_SIDED|90.0|0.72|0.94||Delong 1-sided p-value (alpha=0.05)|Delong Method|The Delong-Delong Clark-Pearson method using modified U-statistics was used to evaluate the AUC||"ROC analysis was used to compute the AUC and evaluate if %ΔSUVmax FLT1-FLT3 is predictive of pCR with alpha=0.05.~The Null Hypothesis assumes that the P(%ΔSUVmax FLT1-FLT3\|pCR)= 1 - P(%ΔSUVmax FLT1-FLT3\|non-pCR) that is: H0: AUC =0.5 (guessing)"||.94|.72|<0.001
74048570|NCT00572728|147650246|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Kruskal-Wallis|two-sided p value from Kruskal-Wallis one-way ANOVA||"Kruskal-Wallis one-way ANOVA was used to test whether there was a difference in %SUVmax (FLT1-FLT2) among LN statuses.~H0: no difference between the 3 LN status."||||0.86
74048571|NCT00572728|147650247|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||two-sided p value from Kruskal-Wallis one-way ANOVA|Kruskal-Wallis|||||||0.67
73880948|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9019|TWO_SIDED|95.0|0.34|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.45|0.34|0.9019
73880949|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.62||||0.4425|TWO_SIDED|95.0|0.18|2.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.10|0.18|0.4425
73880950|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3106|TWO_SIDED|95.0|0.17|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.77|0.17|0.3106
74048572|NCT00679380|147650248|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|3.8||||0.2876|TWO_SIDED|95.0|-3.0|10.5|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Entocort EC and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Entocort EC versus budesonide MMX.||10.5|-3.0|0.2876
73880951|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.32||||0.0912|TWO_SIDED|95.0|0.08|1.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.20|0.08|0.0912
74048573|NCT00679380|147650248|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|12.9||||0.0047|TWO_SIDED|95.0|4.6|21.3|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||21.3|4.6|0.0047
74048574|NCT00679380|147650248|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.1||||0.0481|TWO_SIDED|95.0|0.4|15.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||15.9|0.4|0.0481
74048575|NCT00679380|147650249|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-8.0||||0.2174|TWO_SIDED|95.0|-20.8||||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.||4.|-20.8|0.2174
74048576|NCT00679380|147650249|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.5||||0.2215|TWO_SIDED|95.0|-5.0|22.0|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||22.0|-5.0|0.2215
74048577|NCT00679380|147650249|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-0.7||||0.9185|TWO_SIDED|95.0|-14.1|12.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||12.7|-14.1|0.9185
74048578|NCT00679380|147650250|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.4||||0.4293|TWO_SIDED|95.0|-8.0|18.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Entocort EC and placebo groups is shown here.||18.8|-8.0|0.4293
74048579|NCT02724111|147650257|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74048580|NCT02724111|147650258|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74048581|NCT02724111|147650259|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74048582|NCT02724111|147650260|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74048583|NCT02724111|147650261|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74097717|NCT01442688|147744404|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.94|1.04|||ANOVA|||||1.04|0.940|
74097718|NCT00176423|147744417|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73888102|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5||||0.0367|TWO_SIDED|95.0|1.5|47.4|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||47.4|1.5|0.0367
74097719|NCT00176423|147744418|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
74048584|NCT02724111|147650262|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74048585|NCT02724111|147650263|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
74048586|NCT02724111|147650264|SUPERIORITY|||||||0.202|||||||Chi-squared|||||||0.202
74097720|NCT00176423|147744419|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
74048587|NCT01828567|147650265|OTHER|A logistic regression model was used. The null hypothesis is that there is no difference in improvement prevention program enrollment between the usual care and intervention arms by month 6.|Odds Ratio (OR)|2.54|||<|0.0001|TWO_SIDED|95.0|1.66|3.89|||Regression, Logistic|||The first primary outcome is the cumulative enrollment in prevention programs over the six months of follow up. This will be assessed via self-report at months 1 and 6. As defined by the eligibility criteria, all patients will have a value of 0 at baseline.||3.89|1.66|<.0001
74048588|NCT01828567|147650267|OTHER||Mean Difference (Final Values)|1.5||||0.204|TWO_SIDED|95.0|-0.8|3.7||A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 1 month.|For the primary hypothesis we will be examining the effect during the 1-month long intervention delivery period.||3.7|-0.8|0.204
74048589|NCT01828567|147650268|EQUIVALENCE|This model assumes the groups have equal baseline means, which is appropriate for a randomized controlled trial and is equivalent in efficiency to an ANCOVA model.|Mean Difference (Final Values)|2.5||||0.03|TWO_SIDED|95.0|0.2|4.7||A general Linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time. For the primary hypothesis we will be assessing sustainability at 6 months.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 6 month.|||4.7|0.2|0.030
74048590|NCT01828567|147650270|EQUIVALENCE|This model assumes the groups have equal baseline means|Mean Difference (Final Values)|0.7||||0.33|TWO_SIDED|95.0|-0.7|2.2|||Repeated Measures|A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in FRS scores between the usual care and intervention arms at 6 month.|Our secondary outcome of interest is the Framingham Risk Score, measured at baseline and month 6.||2.2|-0.7|0.330
74097721|NCT00176423|147744420|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
74097722|NCT05502081|147744421|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097723|NCT05502081|147744421|SUPERIORITY|||||||0.176|||||||Kruskal-Wallis|||||||0.176
74097724|NCT05502081|147744421|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097725|NCT05502081|147744421|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097726|NCT05502081|147744422|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
74097727|NCT05502081|147744422|SUPERIORITY|||||||0.021|||||||Kruskal-Wallis|||||||0.021
74097728|NCT05502081|147744422|SUPERIORITY|||||||0.42|||||||Kruskal-Wallis|||||||0.42
74097729|NCT05502081|147744422|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
74097730|NCT05502081|147744423|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
74097731|NCT05502081|147744424|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
74097732|NCT05502081|147744424|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
74097733|NCT05502081|147744424|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
74097734|NCT05502081|147744424|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
74097735|NCT05502081|147744425|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097736|NCT05502081|147744425|SUPERIORITY|||||||0.119|||||||Kruskal-Wallis|||||||0.119
74097737|NCT05502081|147744425|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
73880952|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5681|TWO_SIDED|95.0|0.2|2.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.41|0.20|0.5681
74048591|NCT00113555|147650274|SUPERIORITY||Mean Difference (Net)|-1.16|STANDARD_DEVIATION|1.05|<|0.001|TWO_SIDED|95.0|-1.325|-1.003|||Wilcoxon (Mann-Whitney)|||Wilcoxon's matched pairs signed ranks test was used to determine the significance of differences between scores at follow-up compared to pre-implant.||-1.003|-1.325|<0.001
74048592|NCT05307523|147650284|OTHER|Paired t-test for normally distributed data Wilcoxon Rank test for the not normally distributed data|||||<|0.05||||||Paired T-test for the normally distributed data and a Wilcoxon Rank test for the non-parametric data were used|Both Paired T-test and Wilcoxon Rank|The data included both normally and not normally distributed data for the baseline, mid-study, and final study assessment points.||||||<0.05
74048593|NCT02875366|147650304|SUPERIORITY||Least Squares Mean Difference|-3.2||||0.3021|TWO_SIDED|95.0|-9.2|2.9|||Mixed effects model for repeated measure|||||2.9|-9.2|0.3021
74048594|NCT02875366|147650305|SUPERIORITY||Least Squares Mean Difference|-3.2||||0.1894|TWO_SIDED|95.0|-8.0|1.6|||Mixed effects model for repeated measure|||||1.6|-8.0|0.1894
74048595|NCT02875366|147650306|SUPERIORITY||Least Squares Mean Difference|-15.3||||0.2328|TWO_SIDED|95.0|-40.8|10.1|||Mixed effects model for repeated measure|||||10.1|-40.8|0.2328
74048596|NCT02875366|147650307|SUPERIORITY||Least Squares Mean Difference|-1.4||||0.1203|TWO_SIDED|95.0|-3.1|0.4|||Mixed effects model for repeated measure|||||0.4|-3.1|0.1203
74048597|NCT02875366|147650308|SUPERIORITY||Least Squares Mean Difference|-149.6||||0.0439|TWO_SIDED|95.0|-295.0|-4.2|||Mixed effects model for repeated measure|||||-4.2|-295.0|0.0439
74048598|NCT02875366|147650309|SUPERIORITY||Least Squares Mean Difference|-7.5||||0.2237|TWO_SIDED|95.0|-19.8|4.7|||Mixed effects model for repeated measure|||||4.7|-19.8|0.2237
74048599|NCT02875366|147650310|SUPERIORITY||Least Squares Mean Difference|-0.6||||0.0226|TWO_SIDED|95.0|-1.12|-0.09|||Mixed effects model for repeated measure|||||-0.09|-1.12|0.0226
74048600|NCT02875366|147650311|SUPERIORITY||Least Squares Mean Difference|-6.32||||0.0613|TWO_SIDED|95.0|-12.94|0.31|||Mixed effects model for repeated measure|||||0.31|-12.94|0.0613
74048601|NCT02875366|147650312|SUPERIORITY||Least Squares Mean Difference|0.3||||0.6409|TWO_SIDED|95.0|-0.9|1.5|||Mixed effects model for repeated measure|||||1.5|-0.9|0.6409
74048602|NCT02875366|147650313|SUPERIORITY||Least Squares Mean Difference|1.0||||0.5889|TWO_SIDED|95.0|-2.7|4.7|||Mixed effects model for repeated measure|||||4.7|-2.7|0.5889
74048603|NCT02875366|147650314|SUPERIORITY||Least Squares Mean Difference|3.4||||0.146|TWO_SIDED|95.0|-1.2|8.1|||Mixed effects model for repeated measure|||||8.1|-1.2|0.1460
74048604|NCT02875366|147650315|SUPERIORITY||Least Squares Mean Difference|3.5||||0.3091|TWO_SIDED|95.0|-3.4|10.4|||Mixed effects model for repeated measure|||||10.4|-3.4|0.3091
74048605|NCT02875366|147650316|SUPERIORITY||Least Squares Mean Difference|0.2||||0.3961|TWO_SIDED|95.0|-0.3|0.6|||Mixed effects model for repeated measure|||||0.6|-0.3|0.3961
74048606|NCT02875366|147650317|SUPERIORITY||Least Squares Mean Difference|0.9||||0.3905|TWO_SIDED|95.0|-1.2|3.1|||Mixed effects model for repeated measure|||||3.1|-1.2|0.3905
74048607|NCT02875366|147650318|SUPERIORITY||Least Squares Mean Difference|6.2||||0.1257|TWO_SIDED|95.0|-1.8|14.1|||Mixed effects model for repeated measure|||||14.1|-1.8|0.1257
74048608|NCT02735044|147650328|NON_INFERIORITY|Non-inferiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference in the mean change in HbA1c from baseline to month 6 was \<0.3%.|LS Mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.172|0.179||||||Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (\<12 years and \>=12 years), and the continuous fixed covariates of the baseline HbA1c value.||0.179|-0.172|
74048609|NCT02735044|147650328|SUPERIORITY|Superiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% CI for the difference between treatment groups was \<0 (zero).||||||0.965||||||Threshold for significance at 0.025 level.|ANCOVA|||A step-wise closed testing approach was used to control the type I error. Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (\<12 years and \>=12 years), and the continuous fixed covariates of the baseline HbA1c value.||||0.965
74048610|NCT01201967|147650346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.68||||0.002|TWO_SIDED|95.0|2.14|9.22|||Mixed Models Analysis|||||9.22|2.14|0.002
74048611|NCT01201967|147650347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.045|TWO_SIDED|95.0|-4.06|-0.05|||Mixed Models Analysis|||||-0.05|-4.06|0.045
74048612|NCT01201967|147650348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.55|TWO_SIDED|95.0|-0.93|1.76|||Mixed Models Analysis|||||1.76|-0.93|0.55
74048613|NCT01201967|147650349|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|11.4|||<|0.001|TWO_SIDED|95.0|5.2|24.9|||Chi-squared|||||24.9|5.20|<0.001
74048614|NCT01201967|147650350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.28|TWO_SIDED|95.0|-0.51|1.76|||Mixed Models Analysis|||||1.76|-0.51|0.28
74048615|NCT01201967|147650351|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.83|TWO_SIDED|95.0|0.63|1.46|||Chi-squared|||||1.46|0.63|0.83
74048616|NCT01201967|147650352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.029|TWO_SIDED|95.0|0.012|0.22|||Mixed Models Analysis|||||0.22|0.012|0.029
74048617|NCT01201967|147650353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59||||0.005|TWO_SIDED|95.0|1.71|9.46|||Mixed Models Analysis|||||9.46|1.71|0.005
74097738|NCT05502081|147744425|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097739|NCT05502081|147744426|SUPERIORITY|||||||0.933|||||||Kruskal-Wallis|||||||0.933
74097740|NCT05502081|147744427|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
74097741|NCT05502081|147744427|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
74097742|NCT05502081|147744427|SUPERIORITY|||||||0.185|||||||Kruskal-Wallis|||||||0.185
74097743|NCT05502081|147744427|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
74097744|NCT05502081|147744428|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097745|NCT05502081|147744428|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
74097746|NCT05502081|147744428|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
73880953|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.58||||0.4261|TWO_SIDED|95.0|0.15|2.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.21|0.15|0.4261
73880954|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7514|TWO_SIDED|95.0|0.24|2.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.82|0.24|0.7514
73880955|NCT03192176|147297627|SUPERIORITY||Odds Ratio (OR)|0.52||||0.2712|TWO_SIDED|95.0|0.16|1.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.67|0.16|0.2712
74048618|NCT01201967|147650354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.11|TWO_SIDED|95.0|-0.54|5.14|||Mixed Models Analysis|||||5.14|-0.54|0.11
73880956|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|4.89||||0.0103|TWO_SIDED|95.0|1.46|16.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.40|1.46|0.0103
73880957|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0011|TWO_SIDED|95.0|2.2|23.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.48|2.20|0.0011
73888103|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|10.1||||0.3797|TWO_SIDED|95.0|-12.6|32.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.9|-12.6|0.3797
74018791|NCT01046695|147589875|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||Decrease in OME use in the TENS Unit during the first and second 24 hours.||||.005
74018792|NCT01046695|147589875|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||Decrease in OME use in the Control Arm during the first and second 24 hours.||||.11
74018793|NCT01046695|147589876|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||t-test, 2 sided|||||||.70
74018794|NCT03072160|147589880|OTHER|||||||0.926||||||CD4|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.926
74018795|NCT03072160|147589880|OTHER|||||||0.445||||||CD8|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.445
74018796|NCT03072160|147589880|OTHER|||||||0.21||||||Tregs|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.210
74018797|NCT03072160|147589880|OTHER|||||||0.78||||||Natural Killer (NK) cells|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.780
74018798|NCT00408694|147589888|OTHER|||||||||||||||||Null hypothesis, H0: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≤ 0.05. Alternative hypothesis, HA: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≥ 0.15.|If 3 of the first 14 patients or 4 of the first 42 patients experience the specified adverse events, then the regimen is considered unacceptable as calculated by the Fleming method for a two-stage design with type I error and the statistical power were set at 0.14 and 0.83, respectively.|||
74018799|NCT00666926|147589920|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|155.66|||||TWO_SIDED|90.0|109.66|220.95|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||220.95|109.66|
74018800|NCT00666926|147589921|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|315.72|||||TWO_SIDED|90.0|227.6|437.97|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||437.97|227.60|
74018801|NCT00666926|147589922|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|496.63|||||TWO_SIDED|90.0|206.24|1195.92|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||1195.92|206.24|
74018802|NCT04871711|147589939|SUPERIORITY||Risk Difference (RD)|9.8||||0.006|TWO_SIDED|95.0|3.6|16.1||5% significance level (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||16.1|3.6|0.006
74018803|NCT04871711|147589940|SUPERIORITY||Risk Difference (RD)|24.1|||<|0.001|TWO_SIDED|95.0|15.5|32.6||Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.6|15.5|<0.001
74018804|NCT04871711|147589941|SUPERIORITY||Risk Difference (RD)|22.8|||<|0.001|TWO_SIDED|95.0|14.0|31.7||Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||31.7|14.0|<0.001
74097747|NCT05502081|147744428|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097748|NCT05502081|147744429|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097749|NCT05502081|147744429|SUPERIORITY|||||||0.758|||||||Kruskal-Wallis|||||||0.758
74097750|NCT05502081|147744429|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097751|NCT05502081|147744429|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097752|NCT05502081|147744430|SUPERIORITY|||||||0.412|||||||Kruskal-Wallis|||||||0.412
74097753|NCT05502081|147744431|SUPERIORITY|||||||0.106|||||||Kruskal-Wallis|||||||0.106
74097754|NCT05502081|147744432|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
74097755|NCT05502081|147744432|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||||||0.06
74097756|NCT05502081|147744432|SUPERIORITY|||||||0.156|||||||Kruskal-Wallis|||||||0.156
74097757|NCT05502081|147744432|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
74097758|NCT05502081|147744433|SUPERIORITY|||||||0.219|||||||Kruskal-Wallis|||||||0.219
74097759|NCT05502081|147744434|SUPERIORITY|||||||0.298|||||||Kruskal-Wallis|||||||0.298
74097760|NCT05502081|147744435|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
74018805|NCT04871711|147589942|SUPERIORITY||Risk Difference (RD)|12.3||||0.001|TWO_SIDED|95.0|5.7|18.9||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||18.9|5.7|0.001
74018806|NCT04871711|147589943|SUPERIORITY||Risk Difference (RD)|10.4|||<|0.001|TWO_SIDED|95.0|5.3|15.6||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||15.6|5.3|<0.001
74097761|NCT05502081|147744435|SUPERIORITY|||||||0.232|||||||Kruskal-Wallis|||||||0.232
74097762|NCT05502081|147744435|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
74097763|NCT05502081|147744435|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
74097764|NCT05502081|147744436|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
74097765|NCT05502081|147744436|SUPERIORITY|||||||0.232|||||||Kruskal-Wallis|||||||0.232
74097766|NCT05502081|147744436|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
74097767|NCT05502081|147744436|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
74097768|NCT05502081|147744437|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
74097769|NCT05502081|147744437|SUPERIORITY|||||||0.557|||||||Kruskal-Wallis|||||||0.557
74097770|NCT05502081|147744437|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
74097771|NCT05502081|147744437|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
74097772|NCT05502081|147744438|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097773|NCT05502081|147744438|SUPERIORITY|||||||0.51|||||||Kruskal-Wallis|||||||0.51
74097774|NCT05502081|147744438|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097775|NCT05502081|147744438|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097776|NCT05502081|147744439|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097777|NCT05502081|147744439|SUPERIORITY|||||||0.891|||||||Kruskal-Wallis|||||||0.891
74097778|NCT05502081|147744439|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097779|NCT05502081|147744439|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097780|NCT05502081|147744440|SUPERIORITY|||||||0.516|||||||Kruskal-Wallis|||||||0.516
74097781|NCT05502081|147744441|SUPERIORITY|||||||0.264|||||||Wilcoxon (Mann-Whitney)|||||||0.264
74097782|NCT05502081|147744442|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097783|NCT05502081|147744442|SUPERIORITY|||||||0.256|||||||Kruskal-Wallis|||||||0.256
74097784|NCT05502081|147744442|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097785|NCT05502081|147744442|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097786|NCT05502081|147744443|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
74097787|NCT05502081|147744443|SUPERIORITY|||||||0.797|||||||Kruskal-Wallis|||||||0.797
74097788|NCT05502081|147744443|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
74097789|NCT05502081|147744443|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
74097790|NCT05502081|147744444|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
74097791|NCT05502081|147744445|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097792|NCT05502081|147744445|SUPERIORITY|||||||0.982|||||||Kruskal-Wallis|||||||0.982
74097793|NCT05502081|147744445|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097794|NCT05502081|147744445|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097795|NCT05502081|147744446|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
74097796|NCT05502081|147744446|SUPERIORITY|||||||0.136|||||||Kruskal-Wallis|||||||0.136
74097797|NCT05502081|147744446|SUPERIORITY|||||||0.062|||||||Kruskal-Wallis|||||||0.062
74097798|NCT05502081|147744446|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
74097799|NCT05502081|147744447|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
74097800|NCT05502081|147744448|SUPERIORITY|||||||0.687|||||||Kruskal-Wallis|||||||0.687
74097801|NCT05502081|147744449|SUPERIORITY|||||||0.278|||||||Kruskal-Wallis|||||||0.278
74097802|NCT05502081|147744450|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
74097803|NCT05502081|147744451|SUPERIORITY|||||||0.574|||||||Kruskal-Wallis|||||||0.574
74097804|NCT05502081|147744452|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
74097805|NCT05502081|147744452|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
74097806|NCT05502081|147744452|SUPERIORITY|||||||0.041|||||||Kruskal-Wallis|||||||0.041
74097807|NCT05502081|147744452|SUPERIORITY|||||||0.616|||||||Kruskal-Wallis|||||||0.616
74097808|NCT05502081|147744453|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
74097809|NCT05502081|147744454|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
73880958|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|11.06|||<|0.0001|TWO_SIDED|95.0|3.41|35.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||35.86|3.41|<0.0001
73880959|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|10.48||||0.0001|TWO_SIDED|95.0|3.18|34.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||34.55|3.18|0.0001
74048619|NCT04191096|147650371|OTHER||Hazard Ratio (HR)|1.2||||0.9467|TWO_SIDED|95.0|0.96|1.49||A one-sided p-value was calculated using the log-rank test stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||1.49|0.96|0.9467
74048620|NCT04191096|147650372|OTHER||Hazard Ratio (HR)|1.16||||0.85122|TWO_SIDED|95.0|0.88|1.53||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.53|0.88|0.85122
74048621|NCT04191096|147650373|OTHER||Hazard Ratio (HR)|1.24||||0.97907|TWO_SIDED|95.0|1.01|1.54||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.54|1.01|0.97907
74048622|NCT04191096|147650374|OTHER||Hazard Ratio (HR)|0.89||||0.27202|TWO_SIDED|95.0|0.61|1.3||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.30|0.61|0.27202
74048623|NCT04191096|147650375|OTHER||Hazard Ratio (HR)|0.92||||0.2972|TWO_SIDED|95.0|0.69|1.23||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.23|0.69|0.2972
74048624|NCT04191096|147650376|OTHER||Hazard Ratio (HR)|1.07||||0.6863|TWO_SIDED|95.0|0.81|1.41||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.41|0.81|0.6863
74048625|NCT04191096|147650377|OTHER||Hazard Ratio (HR)|1.15||||0.9235|TWO_SIDED|95.0|0.95|1.39||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.39|0.95|0.9235
74048626|NCT04191096|147650378|OTHER||Hazard Ratio (HR)|1.16||||0.8801|TWO_SIDED|95.0|0.9|1.5||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||1.50|0.90|0.8801
74048627|NCT04191096|147650379|OTHER||Percent Difference|-2.7||||0.9576|TWO_SIDED|95.0|-5.8|0.4||One-sided p-value based on Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen method||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||0.4|-5.8|0.9576
74048628|NCT04191096|147650380|OTHER||Percent difference|-0.8||||0.6053|TWO_SIDED|95.0|-6.3|4.8||One-sided p-value based on Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||4.8|-6.3|0.6053
74048629|NCT04191096|147650381|OTHER||Percent difference|-5.6||||0.9105|TWO_SIDED|95.0|-13.7|2.6||One-sided p-value based on Miettinen \& Nurminen method stratified prior docataxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docataxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||2.6|-13.7|0.9105
74048630|NCT03128307|147650385|SUPERIORITY||||||<|0.0001||||||Assuming a priori threshold for statistical significant of p = 0.05|t-test, 2 sided|||||||< 0.0001
74048631|NCT03128307|147650386|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance of p = 0.05|t-test, 2 sided|||||||< 0.0001
74048632|NCT01693562|147650427|EQUIVALENCE|Other||||||0.016|||||||Regression, Cox|||||||0.016
74048633|NCT01693562|147650428|EQUIVALENCE|Other||||||0.0046|||||||Regression, Cox|||||||0.0046
73880960|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1571|TWO_SIDED|95.0|0.71|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.55|0.71|0.1571
73880961|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|7.14||||0.001|TWO_SIDED|95.0|2.21|23.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.04|2.21|0.0010
73880962|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|7.35||||0.0008|TWO_SIDED|95.0|2.29|23.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.61|2.29|0.0008
73880963|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.78||||0.0342|TWO_SIDED|95.0|1.08|7.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.18|1.08|0.0342
73880964|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0231|TWO_SIDED|95.0|1.16|7.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.66|1.16|0.0231
74018807|NCT04871711|147589944|SUPERIORITY||Risk Difference (RD)|21.0|||<|0.001|TWO_SIDED|95.0|12.6|29.4||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.4|12.6|<0.001
74018808|NCT04871711|147589945|SUPERIORITY||Risk Difference (RD)|19.5|||<|0.001|TWO_SIDED|95.0|12.5|26.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||26.5|12.5|<0.001
74018809|NCT04871711|147589946|SUPERIORITY||Risk Difference (RD)|9.3||||0.004|TWO_SIDED|95.0|3.8|14.7||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||14.7|3.8|0.004
74018810|NCT04871711|147589947|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|14.4|30.6||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||30.6|14.4|<0.001
74018811|NCT04871711|147589948|SUPERIORITY||Risk Difference (RD)|19.5|||<|0.001|TWO_SIDED|95.0|12.5|26.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||26.5|12.5|<0.001
74018812|NCT04871711|147589949|SUPERIORITY||Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|12.4|30.9||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||30.9|12.4|<0.001
74018813|NCT04871711|147589950|SUPERIORITY||Risk Difference (RD)|23.9|||<|0.001|TWO_SIDED|95.0|15.2|32.7||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.7|15.2|<0.001
74018814|NCT04871711|147589951|SUPERIORITY||Risk Difference (RD)|19.6|||<|0.001|TWO_SIDED|95.0|11.8|27.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||27.5|11.8|<0.001
74048634|NCT00887822|147650450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.8636|TWO_SIDED|95.0|0.75|1.41|||Log Rank|The difference in distribution of survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.41|0.75|0.8636
74097810|NCT05502081|147744454|SUPERIORITY|||||||0.208|||||||Kruskal-Wallis|||||||0.208
74097811|NCT05502081|147744454|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097812|NCT05502081|147744454|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
74097813|NCT05502081|147744455|SUPERIORITY|||||||0.088|||||||Kruskal-Wallis|||||||0.088
74097814|NCT05502081|147744456|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
74097815|NCT05502081|147744457|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
73880965|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0032|TWO_SIDED|95.0|1.6|10.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.55|1.60|0.0032
73880966|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.89||||0.0059|TWO_SIDED|95.0|1.48|10.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.22|1.48|0.0059
73880967|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2471|TWO_SIDED|95.0|0.68|4.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.59|0.68|0.2471
73880968|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0381|TWO_SIDED|95.0|1.05|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.70|1.05|0.0381
73880969|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.34||||0.0113|TWO_SIDED|95.0|1.31|8.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.48|1.31|0.0113
73880970|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0486|TWO_SIDED|95.0|1.01|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.52|1.01|0.0486
74097816|NCT05502081|147744457|SUPERIORITY|||||||0.151|||||||Kruskal-Wallis|||||||0.151
74097817|NCT05502081|147744457|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
73880971|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.71||||0.035|TWO_SIDED|95.0|1.07|6.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.87|1.07|0.0350
73880972|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0027|TWO_SIDED|95.0|1.65|10.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.90|1.65|0.0027
74097818|NCT05502081|147744457|SUPERIORITY|||||||0.035|||||||Kruskal-Wallis|||||||0.035
73880973|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|4.68||||0.002|TWO_SIDED|95.0|1.76|12.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.47|1.76|0.0020
73880974|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0686|TWO_SIDED|95.0|0.94|6.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.19|0.94|0.0686
73880975|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0034|TWO_SIDED|95.0|1.58|10.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.21|1.58|0.0034
74097819|NCT05502081|147744458|SUPERIORITY|||||||0.037|||||||Kruskal-Wallis|||||||0.037
74097820|NCT05502081|147744458|SUPERIORITY|||||||0.997|||||||Kruskal-Wallis|||||||0.997
74097821|NCT05502081|147744458|SUPERIORITY|||||||0.016|||||||Kruskal-Wallis|||||||0.016
74097822|NCT05502081|147744458|SUPERIORITY|||||||0.014|||||||Kruskal-Wallis|||||||0.014
74097823|NCT05502081|147744459|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
74097824|NCT05502081|147744460|SUPERIORITY|||||||0.047|||||||Kruskal-Wallis|||||||0.047
74097825|NCT05502081|147744460|SUPERIORITY|||||||0.04|||||||Kruskal-Wallis|||||||0.04
74097826|NCT05502081|147744460|SUPERIORITY|||||||0.036|||||||Kruskal-Wallis|||||||0.036
74097827|NCT05502081|147744460|SUPERIORITY|||||||0.67|||||||Kruskal-Wallis|||||||0.67
74097828|NCT05502081|147744461|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
74097829|NCT05502081|147744461|SUPERIORITY|||||||0.027|||||||Kruskal-Wallis|||||||0.027
74097830|NCT05502081|147744461|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
74097831|NCT05502081|147744461|SUPERIORITY|||||||0.38|||||||Kruskal-Wallis|||||||0.38
74097832|NCT05502081|147744462|SUPERIORITY|||||||0.814|||||||Kruskal-Wallis|||||||0.814
74097833|NCT05502081|147744463|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
74097834|NCT05502081|147744464|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097835|NCT05502081|147744464|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097836|NCT05502081|147744464|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097837|NCT05502081|147744464|SUPERIORITY|||||||0.971|||||||Kruskal-Wallis|||||||0.971
74097838|NCT05502081|147744465|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
74097839|NCT05502081|147744465|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097840|NCT05502081|147744466|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
74048635|NCT00887822|147650452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.4709|TWO_SIDED|95.0|0.66|1.21|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.21|0.66|0.4709
74048636|NCT00887822|147650454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3685|TWO_SIDED|95.0|0.58|1.22|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.22|0.58|0.3685
74048637|NCT00887822|147650456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8589|TWO_SIDED|95.0|0.67|1.41|||Log Rank|The difference in distribution of disease progression between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.41|0.67|0.8589
74048638|NCT00887822|147650457|SUPERIORITY_OR_OTHER||Difference in Response Rates|7.02||||0.348|TWO_SIDED|95.0|-8.3|22.4|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||22.4|-8.3|0.3480
74048639|NCT00887822|147650458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.0462|TWO_SIDED|95.0|0.29|1.0|||Log Rank|The difference in distribution of response between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.00|0.29|0.0462
74048640|NCT00887822|147650459|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|0.45||||0.9426|TWO_SIDED|95.0|-12.4|13.3|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||13.3|-12.4|0.9426
74097841|NCT05502081|147744466|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
74097842|NCT05502081|147744466|SUPERIORITY|||||||0.452|||||||Kruskal-Wallis|||||||0.452
74097843|NCT05502081|147744466|SUPERIORITY|||||||0.237|||||||Kruskal-Wallis|||||||0.237
74097844|NCT05502081|147744467|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
74097845|NCT05502081|147744468|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
74048641|NCT02045979|147650462|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 percent (%).|ratio of the geometric means|108.62|||||TWO_SIDED|90.0|98.5|119.79|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||119.79|98.50|
74048642|NCT02045979|147650462|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|101.27|||||TWO_SIDED|90.0|92.45|110.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||110.94|92.45|
74048643|NCT02045979|147650462|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|94.02|||||TWO_SIDED|90.0|86.01|102.78|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.78|86.01|
74048644|NCT02045979|147650463|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|107.32|||||TWO_SIDED|90.0|98.49|116.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||116.94|98.49|
74048645|NCT02045979|147650463|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|99.93|||||TWO_SIDED|90.0|92.15|108.37|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||108.37|92.15|
74097846|NCT05502081|147744468|SUPERIORITY|||||||0.223|||||||Kruskal-Wallis|||||||0.223
74097847|NCT05502081|147744468|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
74097848|NCT05502081|147744468|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
74097849|NCT05502081|147744469|SUPERIORITY|||||||0.423|||||||Kruskal-Wallis|||||||0.423
74097850|NCT05502081|147744470|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||||||0.429
74097851|NCT05502081|147744471|SUPERIORITY|||||||0.089|||||||Kruskal-Wallis|||||||0.089
74097852|NCT05502081|147744472|SUPERIORITY|||||||0.222|||||||Kruskal-Wallis|||||||0.222
74097853|NCT05502081|147744473|SUPERIORITY|||||||0.252|||||||Kruskal-Wallis|||||||0.252
74097854|NCT05502081|147744474|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
74097855|NCT05502081|147744475|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
74097856|NCT05502081|147744475|SUPERIORITY|||||||0.382|||||||Kruskal-Wallis|||||||0.382
74097857|NCT05502081|147744475|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
74097858|NCT05502081|147744475|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
74097859|NCT05502081|147744476|SUPERIORITY|||||||0.457|||||||Kruskal-Wallis|||||||0.457
74097860|NCT05502081|147744477|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
74097861|NCT05502081|147744478|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
74097862|NCT05502081|147744478|SUPERIORITY|||||||0.605|||||||Kruskal-Wallis|||||||0.605
74097863|NCT05502081|147744478|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
74097864|NCT05502081|147744478|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
74097865|NCT05502081|147744479|SUPERIORITY|||||||0.293|||||||Kruskal-Wallis|||||||0.293
74097866|NCT05502081|147744480|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
74097867|NCT05502081|147744481|SUPERIORITY|||||||0.36|||||||Kruskal-Wallis|||||||0.36
74097868|NCT05502081|147744482|SUPERIORITY|||||||0.404|||||||Kruskal-Wallis|||||||0.404
73880976|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0222|TWO_SIDED|95.0|1.16|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.22|1.16|0.0222
74048646|NCT02045979|147650463|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|93.66|||||TWO_SIDED|90.0|86.76|101.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.11|86.76|
74097869|NCT05502081|147744483|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097870|NCT05502081|147744483|SUPERIORITY|||||||0.234|||||||Kruskal-Wallis|||||||0.234
74048647|NCT02045979|147650464|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|100.85|||||TWO_SIDED|90.0|95.15|106.88|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||106.88|95.15|
74048648|NCT02045979|147650464|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|96.39|||||TWO_SIDED|90.0|91.06|102.03|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.03|91.06|
74048649|NCT02045979|147650464|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|95.93|||||TWO_SIDED|90.0|90.83|101.33|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.33|90.83|
74048650|NCT02045979|147650465|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% Confidence Interval (CI) for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.3|||||TWO_SIDED|90.0|91.54|105.55|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.55|91.54|
74048651|NCT02045979|147650465|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|96.05|||||TWO_SIDED|90.0|89.27|103.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.36|89.27|
74048652|NCT02045979|147650465|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.11|||||TWO_SIDED|90.0|91.42|105.27|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.27|91.42|
74048653|NCT02045979|147650466|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|99.61|||||TWO_SIDED|90.0|93.66|105.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.94|93.66|
74048654|NCT02045979|147650466|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.19|||||TWO_SIDED|90.0|91.39|103.35|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.35|91.39|
74048655|NCT02045979|147650466|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.97|||||TWO_SIDED|90.0|92.58|103.68|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.68|92.58|
74048656|NCT02045979|147650467|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.23|||||TWO_SIDED|90.0|95.45|107.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||107.36|95.45|
74048657|NCT02045979|147650467|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.83|||||TWO_SIDED|90.0|93.27|104.72|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||104.72|93.27|
74048658|NCT02045979|147650467|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.01|||||TWO_SIDED|90.0|93.15|103.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.11|93.15|
74048659|NCT02045979|147650468|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|103.68|||||TWO_SIDED|90.0|97.47|110.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||110.29|97.47|
74048660|NCT02045979|147650468|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.16|||||TWO_SIDED|90.0|94.37|106.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||106.29|94.37|
74048661|NCT02045979|147650468|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.02|||||TWO_SIDED|90.0|92.07|102.24|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.24|92.07|
74048662|NCT02045979|147650469|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|106.57|||||TWO_SIDED|90.0|99.07|114.63|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||114.63|99.07|
74048663|NCT02045979|147650469|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.94|||||TWO_SIDED|90.0|94.24|108.12|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||108.12|94.24|
74048664|NCT02045979|147650469|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|95.37|||||TWO_SIDED|90.0|89.53|101.6|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.60|89.53|
74048665|NCT02045979|147650470|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|108.7|||||TWO_SIDED|90.0|98.54|119.9|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||119.90|98.54|
74048666|NCT02045979|147650470|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.36|||||TWO_SIDED|90.0|92.51|111.05|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||111.05|92.51|
74048667|NCT02045979|147650470|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|94.04|||||TWO_SIDED|90.0|86.01|102.82|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.82|86.01|
74048668|NCT02987205|147650477|NON_INFERIORITY|If the upper bound of this 95% CI was less than the prespecified non-inferiority limit of 0.50, the Test product would be claimed to be non-inferior to the Comparator product.||||||0.013||||||Wilcoxon matched-pairs signed rank test|Wilcoxon (Mann-Whitney)|||||||0.0130
74097871|NCT05502081|147744483|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
73880977|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0876|TWO_SIDED|95.0|0.89|5.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.84|0.89|0.0876
74048669|NCT02145429|147650482|OTHER||Hazard Ratio (HR)|0.32||||0.04|TWO_SIDED|95.0|0.1|0.98|||Log Rank|||||0.98|0.10|0.04
74097872|NCT05502081|147744483|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74048670|NCT02145429|147650483|OTHER||Mean Difference (Final Values)|-1.18|||<|0.001|TWO_SIDED|95.0|-2.03|-0.31|||Mixed Models Analysis|||||-0.31|-2.03|<0.001
73880978|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.72||||0.0345|TWO_SIDED|95.0|1.08|6.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.88|1.08|0.0345
74048671|NCT02145429|147650484|OTHER||Mean Difference (Final Values)|-0.14||||0.26|TWO_SIDED|95.0|-1.89|1.62|||Mixed Models Analysis|||||1.62|-1.89|0.26
74048672|NCT04167514|147650492|SUPERIORITY||Odds Ratio (OR)|1.92||||0.034|TWO_SIDED|95.0|0.954|3.866|||One-sided Wald|One-sided Wald test of superior odds of overall response under AAT treatment compared to placebo.Threshold of significance at \<0.025.|Wald CIs|||3.866|0.954|0.034
74097873|NCT05502081|147744484|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097874|NCT05502081|147744484|SUPERIORITY|||||||0.223|||||||Kruskal-Wallis|||||||0.223
74097875|NCT05502081|147744484|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097876|NCT05502081|147744484|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097877|NCT05502081|147744485|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097878|NCT05502081|147744485|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
74097879|NCT05502081|147744485|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097880|NCT05502081|147744485|SUPERIORITY|||||||0.213|||||||Kruskal-Wallis|||||||0.213
74097881|NCT05502081|147744486|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097882|NCT05502081|147744486|SUPERIORITY|||||||0.478|||||||Kruskal-Wallis|||||||0.478
74097883|NCT05502081|147744486|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097884|NCT05502081|147744486|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097885|NCT05502081|147744487|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097886|NCT05502081|147744487|SUPERIORITY|||||||0.413|||||||Kruskal-Wallis|||||||0.413
74097887|NCT05502081|147744487|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097888|NCT05502081|147744487|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097889|NCT05502081|147744488|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
74048673|NCT03345849|147650504|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and European Union/European Medicines Agency regulatory purposes.|Adjusted Response Rate Difference|20.8|||<|0.0001|TWO_SIDED|95.0|12.7|28.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|Comparison of the upadacitinib group and placebo group was performed using the Cochran Mantel-Haenszel (CMH) test adjusting for stratification factors (baseline steroid use \[Yes, No\], endoscopic disease severity \[SES-CD \< 15, ≥ 15\] and number of prior biologics with prior inadequate response or intolerance \[0, 1, \> 1\]).||28.8|12.7|<0.0001
74048674|NCT03345849|147650505|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|28.7|||<|0.0001|TWO_SIDED|95.0|20.9|36.4|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||36.4|20.9|<0.0001
74048675|NCT03345849|147650506|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|33.0|||<|0.0001|TWO_SIDED|95.0|26.2|39.9|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||39.9|26.2|<0.0001
74097890|NCT05502081|147744488|SUPERIORITY|||||||0.155|||||||Kruskal-Wallis|||||||0.155
74097891|NCT05502081|147744488|SUPERIORITY|||||||0.022|||||||Kruskal-Wallis|||||||0.022
74097892|NCT05502081|147744488|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
74097893|NCT05502081|147744489|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
74097894|NCT05502081|147744490|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097895|NCT05502081|147744490|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
74097896|NCT05502081|147744490|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74097897|NCT05502081|147744490|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
74097898|NCT05502081|147744491|SUPERIORITY|||||||0.189|||||||Kruskal-Wallis|||||||0.189
74097899|NCT05502081|147744492|SUPERIORITY|||||||0.414|||||||Wilcoxon (Mann-Whitney)|||||||0.414
74097900|NCT00998309|147744509|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participatns of responders."||||=0.001
74097901|NCT00998309|147744510|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the participatns of responders."||||=1.000
74097902|NCT00998309|147744511|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was type of infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental and Oral Surgery Infection in the participatns of responders."||||<0.001
74097903|NCT00998309|147744512|SUPERIORITY_OR_OTHER||||||=|0.556|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, and severe infection in the participatns of responders."||||=0.556
74097904|NCT00998309|147744513|SUPERIORITY_OR_OTHER||||||=|0.074|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was hepatic dysfunction. The null hypothesis is there is no difference between with and without hepatic dysfunction in the participatns of responders."||||=0.074
74097905|NCT00998309|147744514|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal dysfunction. The null hypothesis is there is no difference between with and without Renal dysfunction in the participatns of responders."||||=1.000
74097906|NCT00998309|147744515|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past medical history. The null hypothesis is there is no difference between with and without past medical history in the participatns of responders."||||=1.000
74097907|NCT00998309|147744516|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications  in the participatns of responders."||||=1.000
74097908|NCT00998309|147744517|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history. The null hypothesis is there is no difference between with and without previous antibiotic treatment history in the participatns of responders."||||=1.000
74097909|NCT00998309|147744518|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the participatns of responders."||||=0.470
74097910|NCT00998309|147744519|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the participatns of responders."||||=1.000
74097911|NCT00998309|147744522|SUPERIORITY_OR_OTHER||||||=|0.657|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.657
74097912|NCT00998309|147744523|SUPERIORITY_OR_OTHER||||||=|0.145|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years or \>=65 in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.145
74097913|NCT00998309|147744524|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Type of Infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental or Oral Surgery Infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.005
74048676|NCT03345849|147650507|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|21.8|||<|0.0001|TWO_SIDED|95.0|15.8|27.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||27.8|15.8|<0.0001
74048677|NCT03345849|147650508|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for US/FDA regulatory purposes.|Adjusted Response Rate Difference|27.7|||<|0.0001|TWO_SIDED|95.0|15.7|39.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors endoscopic disease severity and number of prior failed biologic therapies.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors endoscopic disease severity and number of prior biologic failed.|||39.8|15.7|<0.0001
74048678|NCT03345849|147650509|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Least Squares (LS) Mean Difference|6.3|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|4.2|8.3|||Mixed-effect Model Repeated Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, stratification factors, and Baseline value as covariate.||||8.3|4.2|<0.0001
74048679|NCT03345849|147650510|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|LS Mean Difference|21.842|STANDARD_ERROR_OF_MEAN|3.1933|<|0.0001|TWO_SIDED|95.0|15.566|28.118|||Mixed-effect Model Repeated Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, stratification factors, and Baseline value as covariate.||||28.118|15.566|<0.0001
74048680|NCT03345849|147650511|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|11.7||||0.0022|TWO_SIDED|95.0|4.2|19.2|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||19.2|4.2|0.0022
74048681|NCT03345849|147650512|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|19.8|||<|0.0001|TWO_SIDED|95.0|11.3|28.4|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||28.4|11.3|<0.0001
74048682|NCT03345849|147650513|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for US/FDA regulatory purposes.|Adjusted Response Rate Difference|10.8||||0.0071|TWO_SIDED|95.0|2.9|18.6|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||18.6|2.9|0.0071
74048683|NCT03345849|147650514|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Response Rate Difference|-1.4||||0.4494|TWO_SIDED|95.0|-5.2|2.4|||Chi-squared||Response rate difference = Upadacitinib - Placebo|||2.4|-5.2|0.4494
74097914|NCT00998309|147744525|SUPERIORITY_OR_OTHER||||||=|0.213|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, or severe infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.213
74097915|NCT00998309|147744526|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=1.000
74097916|NCT00998309|147744527|SUPERIORITY_OR_OTHER||||||=|0.116|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.116
74097917|NCT00998309|147744528|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past Medical History. The null hypothesis is there is no difference between with and without Past Medical History in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||<0.001
74097918|NCT00998309|147744529|SUPERIORITY_OR_OTHER||||||=|0.645|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.645
74097919|NCT00998309|147744530|SUPERIORITY_OR_OTHER||||||=|0.679|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history (PATH). The null hypothesis is there is no difference between with and without previous antibiotic treatment history (PTH) in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.679
74097920|NCT00998309|147744531|SUPERIORITY_OR_OTHER||||||=|0.234|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.234
74097921|NCT00998309|147744532|SUPERIORITY_OR_OTHER||||||=|0.039|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.039
74097922|NCT00998309|147744533|SUPERIORITY_OR_OTHER||||||=|0.605|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Pregnancy in Female. The null hypothesis is there is no difference between with and without Pregnancy in the Incidence Rate of Treatment Related Adverse Events (TRAEs) in Female."||||=0.605
74097923|NCT01844505|147744544|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|99.5|0.43|0.76|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipimlimumab.|||0.76|0.43|<0.0001
74097924|NCT01844505|147744544|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|99.5|0.31|0.57|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.|||0.57|0.31|<0.0001
74097925|NCT01844505|147744545|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|98.0|0.5|0.78|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the Interactive Voice Response System (IVRS).|Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipilimumab|||0.78|0.50|<0.0001
73880979|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0319|TWO_SIDED|95.0|1.09|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.99|1.09|0.0319
74097926|NCT01844505|147744545|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|98.0|0.42|0.72|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the IVRS.|Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.|||0.72|0.42|<0.0001
74097927|NCT01844505|147744548|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.65|0.96|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||0.96|0.65|
74097928|NCT01844505|147744549|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.05|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.05|0.69|
73880980|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|5.27||||0.0013|TWO_SIDED|95.0|1.92|14.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.47|1.92|0.0013
74097929|NCT01844505|147744550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.49|5.16|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab over Ipilimumab.|||5.16|2.49|<0.0001
74097930|NCT01844505|147744550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.35|||<|0.0001|TWO_SIDED|95.0|4.38|9.22|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Ipilimumab.|||9.22|4.38|<0.0001
74097931|NCT01844505|147744550|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|26.0|||||TWO_SIDED|95.0|19.1|32.8|||||Difference in ORR and corresponding 95% CI is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab - Ipilimumab.|||32.8|19.1|
74097932|NCT01844505|147744550|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|39.0|||||TWO_SIDED|95.0|32.2|45.9|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Ipilimumab.|||45.9|32.2|
74097933|NCT01844505|147744550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|1.26|2.42|||||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Nivolumab|||2.42|1.26|
74097934|NCT01844505|147744550|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|13.2|||||TWO_SIDED|95.0|5.7|20.7|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Nivolumab.|||20.7|5.7|
74097935|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.46|0.85|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.85|0.46|
74097936|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.28|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.54|0.28|
74048684|NCT03345849|147650515|OTHER|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|9.0||||0.1044|TWO_SIDED|95.0|-1.9|19.9|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||19.9|-1.9|0.1044
74048685|NCT03345849|147650516|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Adjusted Response Rate Difference|21.2|||<|0.0001|TWO_SIDED|95.0|14.3|28.2|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||28.2|14.3|<0.0001
74048686|NCT03345849|147650517|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Adjusted Response Rate Difference|32.6|||<|0.0001|TWO_SIDED|95.0|21.5|43.7|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||43.7|21.5|<0.0001
74048687|NCT05618808|147650545|SUPERIORITY||Posterior Odds Ratio|0.78|||||TWO_SIDED|90.0|0.47|1.32|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.32|0.47|
74048688|NCT05618808|147650548|SUPERIORITY||Posterior Odds Ratio|0.44|||||TWO_SIDED|90.0|0.16|1.61|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.61|0.16|
74048689|NCT05618808|147650549|SUPERIORITY||Posterior Odds Ratio|0.79|||||TWO_SIDED|90.0|0.47|1.32|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.32|0.47|
74048690|NCT05618808|147650555|SUPERIORITY||Posterior Odds Ratio|0.54|||||TWO_SIDED|90.0|0.32|0.95|||||Enoxaparin vs Apixaban||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|0.95|0.32|
74048691|NCT05085275|147650572|NON_INFERIORITY|The study planned to enroll 400 patients (200 patients in each treatment arm) to achieve 90% power to detect a hazard ratio (HR) of 0.60 for the primary composite endpoint, with differences between treatment groups assessed using a 2-sided alpha of \<0.05|Hazard Ratio (HR)|0.73||||0.1602|TWO_SIDED|95.0|0.46|1.14|||Regression, Cox|||||1.14|0.46|.1602
74048692|NCT05085275|147650574|OTHER||Hazard Ratio (HR)|0.78|STANDARD_ERROR_OF_MEAN|0.2392||0.3|||||||Regression, Cox|||||||.30
74048693|NCT05085275|147650575|OTHER||Hazard Ratio (HR)|0.35|STANDARD_ERROR_OF_MEAN|0.8295||0.17|||||||Regression, Cox|||||||0.17
74097937|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.45|0.87|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%|||0.87|0.45|
74048694|NCT04566445|147650620|SUPERIORITY||LS Mean Difference|0.062|STANDARD_ERROR_OF_MEAN|0.0901|||TWO_SIDED|90.0|-0.087|0.211|||mixed model repeated measures|||Week 12||0.211|-0.087|
74097938|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.34|0.59|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.59|0.34|
74048695|NCT04566445|147650620|SUPERIORITY||LS Mean Difference|0.084|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|90.0|-0.066|0.234|||mixed model repeated measures|||Week 12||0.234|-0.066|
74048696|NCT04566445|147650620|SUPERIORITY||LS Mean Difference|0.096|STANDARD_ERROR_OF_MEAN|0.1198|||TWO_SIDED|90.0|-0.102|0.294|||mixed model repeated measures|||Week 24||0.294|-0.102|
74048697|NCT04566445|147650620|SUPERIORITY||LS Mean Difference|0.205|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|0.007|0.404|||mixed model repeated measures|||Week 24||0.404|0.007|
74048698|NCT04566445|147650620|SUPERIORITY||LS Mean Difference|0.197|STANDARD_ERROR_OF_MEAN|0.2135|||TWO_SIDED|90.0|-0.155|0.55|||mixed model repeated measures|||Week 36||0.550|-0.155|
74048699|NCT04566445|147650620|SUPERIORITY||LS Mean Difference|0.423|STANDARD_ERROR_OF_MEAN|0.2152|||TWO_SIDED|90.0|0.068|0.779|||mixed model repeated measures|||Week 36||0.779|0.068|
74048700|NCT04566445|147650620|SUPERIORITY||LS Mean Difference|0.052|STANDARD_ERROR_OF_MEAN|0.2644|||TWO_SIDED|90.0|-0.385|0.489|||mixed model repeated measures|||Week 48||0.489|-0.385|
74048701|NCT04566445|147650620|SUPERIORITY||LS Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.2662|||TWO_SIDED|90.0|0.049|0.928|||mixed model repeated measures|||Week 48||0.928|0.049|
74048702|NCT04566445|147650620|SUPERIORITY||LS Mean Difference|0.307|STANDARD_ERROR_OF_MEAN|0.3361|||TWO_SIDED|90.0|-0.248|0.862|||mixed model repeated measures|||Week 72||0.862|-0.248|
74048703|NCT04566445|147650620|SUPERIORITY||LS Mean Difference|0.503|STANDARD_ERROR_OF_MEAN|0.3392|||TWO_SIDED|90.0|-0.058|1.063|||mixed model repeated measures|||Week 72||1.063|-0.058|
74048704|NCT04566445|147650621|SUPERIORITY||LS Mean Difference|0.645|STANDARD_ERROR_OF_MEAN|0.4527|||TWO_SIDED|90.0|-0.103|1.393|||mixed model repeated measures|||Week 96||1.393|-0.103|
74048705|NCT04566445|147650621|SUPERIORITY||LS Mean Difference|0.838|STANDARD_ERROR_OF_MEAN|0.4577|||TWO_SIDED|90.0|0.081|1.594|||mixed model repeated measures|||Week 96||1.594|0.081|
74048706|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|-2.6|1.7|||mixed model repeated measures|||Week 12||1.7|-2.6|
74048707|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-4.0|0.4|||mixed model repeated measures|||Week 12||0.4|-4.0|
74048708|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-4.1|0.8|||mixed model repeated measures|||Week 24||0.8|-4.1|
74097939|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.3|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.53|0.30|
74097940|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.66|1.21|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%|||1.21|0.66|
74097941|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.45|0.71|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.71|0.45|
74097942|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.33|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.53|0.33|
74097943|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.57|0.94|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%|||0.94|0.57|
74097944|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.27|0.6|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.60|0.27|
74097945|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.22|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.54|0.22|
74097946|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.54|1.38|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%|||1.38|0.54|
74097947|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.43|0.67|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.67|0.43|
74097948|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.34|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.54|0.34|
74097949|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.63|1.01|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 10%|||1.01|0.63|
73880981|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.91||||0.1751|TWO_SIDED|95.0|0.75|4.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.87|0.75|0.1751
74097950|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.28|0.73|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.73|0.28|
74097951|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.16|0.49|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.49|0.16|
74097952|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.34|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 10%|||1.09|0.34|
73880982|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0019|TWO_SIDED|95.0|1.73|11.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.50|1.73|0.0019
74097953|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.49|1.52|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||1.52|0.49|
74097954|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.3|0.89|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||0.89|0.30|
74097955|NCT01844505|147744551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.33|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline|||1.09|0.33|
74097956|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.57|1.05|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||1.05|0.57|
74097957|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.43|0.81|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.81|0.43|
74097958|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||||95.0|0.55|1.04|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%|||1.04|0.55|
74097959|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.39|0.68|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.68|0.39|
74097960|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.38|0.67|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.67|0.38|
74097961|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.72|1.31|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%|||1.31|0.72|
74097962|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.49|0.78|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.78|0.49|
74097963|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.41|0.66|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.66|0.41|
74097964|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.66|1.08|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%|||1.08|0.66|
74097965|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.41|0.91|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.91|0.41|
74097966|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.38|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.91|0.38|
74097967|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.62|1.53|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%|||1.53|0.62|
74097968|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.48|0.75|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.75|0.48|
74097969|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.43|0.68|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.68|0.43|
74048709|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.49|||TWO_SIDED|90.0|-7.7|-2.8|||mixed model repeated measures|||Week 24||-2.8|-7.7|
74048710|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|90.0|-2.5|3.5|||mixed model repeated measures|||Week 36||3.5|-2.5|
74048711|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|90.0|-7.7|-1.7|||mixed model repeated measures|||Week 36||-1.7|-7.7|
74048712|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.14|||TWO_SIDED|90.0|-0.9|6.1|||mixed model repeated measures|||Week 48||6.1|-0.9|
74048713|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|-5.6|1.4|||mixed model repeated measures|||Week 48||1.4|-5.6|
74048714|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.24|||TWO_SIDED|90.0|1.0|8.4|||mixed model repeated measures|||Week 72||8.4|1.0|
74048715|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.2|||TWO_SIDED|90.0|-2.8|4.5|||mixed model repeated measures|||Week 72||4.5|-2.8|
74048716|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|90.0|2.7|11.6|||mixed model repeated measures|||Week 96||11.6|2.7|
74048717|NCT04566445|147650626|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|90.0|-1.8|7.1|||mixed model repeated measures|||Week 96||7.1|-1.8|
74048718|NCT01263470|147650663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||||TWO_SIDED|95.0|-0.755|-0.386||||||||-0.386|-0.755|
74048719|NCT01263470|147650663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.762|||||TWO_SIDED|95.0|-0.925|-0.598||||||||-0.598|-0.925|
74048720|NCT01263470|147650663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.826|||||TWO_SIDED|95.0|-0.987|-0.665||||||||-0.665|-0.987|
74048721|NCT01263470|147650663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.887|||||TWO_SIDED|95.0|-1.035|-0.739||||||||-0.739|-1.035|
74048722|NCT01263470|147650663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|||||TWO_SIDED|95.0|-0.57|-0.132||||||||-0.132|-0.570|
74048723|NCT01263470|147650663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.542|||||TWO_SIDED|95.0|-0.743|-0.342||||||||-0.342|-0.743|
74048724|NCT01263470|147650663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.607|||||TWO_SIDED|95.0|-0.808|-0.406||||||||-0.406|-0.808|
74048725|NCT01263470|147650663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.667|||||TWO_SIDED|95.0|-0.859|-0.475||||||||-0.475|-0.859|
74048726|NCT01263470|147650664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|||||TWO_SIDED|95.0|-0.213|-0.104||||||||-0.104|-0.213|
74048727|NCT01263470|147650664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|||||TWO_SIDED|95.0|-0.234|-0.114||||||||-0.114|-0.234|
74048728|NCT01263470|147650664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.219|-0.1||||||||-0.100|-0.219|
74048729|NCT01263470|147650664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153|||||TWO_SIDED|95.0|-0.212|-0.095||||||||-0.095|-0.212|
74048730|NCT01263470|147650664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059|||||TWO_SIDED|95.0|-0.116|-0.003||||||||-0.003|-0.116|
74048731|NCT01263470|147650664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075|||||TWO_SIDED|95.0|-0.136|-0.014||||||||-0.014|-0.136|
74048732|NCT01263470|147650664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|||||TWO_SIDED|95.0|-0.121|0.0||||||||0.000|-0.121|
74048733|NCT01263470|147650664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|||||TWO_SIDED|95.0|-0.114|0.006||||||||0.006|-0.114|
74048734|NCT01263470|147650665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|||||TWO_SIDED|95.0|-0.419|-0.233||||||||-0.233|-0.419|
74048735|NCT01263470|147650665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.369|||||TWO_SIDED|95.0|-0.47|-0.268||||||||-0.268|-0.470|
74048736|NCT01263470|147650665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||||TWO_SIDED|95.0|-0.438|-0.241||||||||-0.241|-0.438|
74048737|NCT01263470|147650665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387|||||TWO_SIDED|95.0|-0.485|-0.288||||||||-0.288|-0.485|
74048738|NCT01263470|147650665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|||||TWO_SIDED|95.0|-0.28|-0.076||||||||-0.076|-0.280|
74048739|NCT01263470|147650665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.221|||||TWO_SIDED|95.0|-0.329|-0.112||||||||-0.112|-0.329|
74048740|NCT01263470|147650665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.192|||||TWO_SIDED|95.0|-0.299|-0.085||||||||-0.085|-0.299|
74048741|NCT01263470|147650665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.239|||||TWO_SIDED|95.0|-0.346|-0.131||||||||-0.131|-0.346|
74048742|NCT01263470|147650666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.644|-0.356||||||||-0.356|-0.644|
74048743|NCT01263470|147650666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.614|||||TWO_SIDED|95.0|-0.763|-0.464||||||||-0.464|-0.763|
74048744|NCT01263470|147650666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-0.804|-0.516||||||||-0.516|-0.804|
74048745|NCT01263470|147650666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.695|||||TWO_SIDED|95.0|-0.832|-0.559||||||||-0.559|-0.832|
74048746|NCT01263470|147650666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.325|||||TWO_SIDED|95.0|-0.494|-0.156||||||||-0.156|-0.494|
74048747|NCT01263470|147650666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.438|||||TWO_SIDED|95.0|-0.61|-0.267||||||||-0.267|-0.610|
74048748|NCT01263470|147650666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.485|||||TWO_SIDED|95.0|-0.654|-0.315||||||||-0.315|-0.654|
74048749|NCT01263470|147650666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||||TWO_SIDED|95.0|-0.683|-0.357||||||||-0.357|-0.683|
74048750|NCT01263470|147650667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-23.27|-7.93||||||||-7.93|-23.27|
74048751|NCT01263470|147650667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.69|||||TWO_SIDED|95.0|-25.34|-10.05||||||||-10.05|-25.34|
74048752|NCT01263470|147650667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|||||TWO_SIDED|95.0|-24.14|-8.02||||||||-8.02|-24.14|
74048753|NCT01263470|147650667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.47|||||TWO_SIDED|95.0|-32.06|-14.89||||||||-14.89|-32.06|
74048754|NCT01263470|147650667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-12.66|1.02||||||||1.02|-12.66|
74048755|NCT01263470|147650667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||||TWO_SIDED|95.0|-14.76|-1.08||||||||-1.08|-14.76|
74097970|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.71|1.14|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 10%|||1.14|0.71|
74048756|NCT01263470|147650667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-13.53|0.93||||||||0.93|-13.53|
74048757|NCT01263470|147650667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69|||||TWO_SIDED|95.0|-21.45|-5.94||||||||-5.94|-21.45|
74048758|NCT01263470|147650668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-23.27|-7.93||||||||-7.93|-23.27|
74048759|NCT01263470|147650668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.69|||||TWO_SIDED|95.0|-25.34|-10.05||||||||-10.05|-25.34|
74048760|NCT01263470|147650668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|||||TWO_SIDED|95.0|-24.14|-8.02||||||||-8.02|-24.14|
74048761|NCT01263470|147650668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.47|||||TWO_SIDED|95.0|-32.06|-14.89||||||||-14.89|-32.06|
74048762|NCT01263470|147650668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-12.66|1.02||||||||1.02|-12.66|
74048763|NCT01263470|147650668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||||TWO_SIDED|95.0|-14.76|-1.08||||||||-1.08|-14.76|
74048764|NCT01263470|147650668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-13.53|0.93||||||||0.93|-13.53|
74048765|NCT01263470|147650668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69|||||TWO_SIDED|95.0|-21.45|-5.94||||||||-5.94|-21.45|
74048766|NCT01263470|147650669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.73|||||TWO_SIDED|95.0|-26.52|-8.94||||||||-8.94|-26.52|
74048767|NCT01263470|147650669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.22|||||TWO_SIDED|95.0|-32.07|-16.37||||||||-16.37|-32.07|
74048768|NCT01263470|147650669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.34|||||TWO_SIDED|95.0|-32.03|-16.65||||||||-16.65|-32.03|
74048769|NCT01263470|147650669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.28|||||TWO_SIDED|95.0|-37.04|-19.52||||||||-19.52|-37.04|
74048770|NCT01263470|147650669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|||||TWO_SIDED|95.0|-17.28|0.18||||||||0.18|-17.28|
74048771|NCT01263470|147650669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.04|||||TWO_SIDED|95.0|-22.9|-7.18||||||||-7.18|-22.90|
74048772|NCT01263470|147650669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.16|||||TWO_SIDED|95.0|-22.9|-7.42||||||||-7.42|-22.90|
74048773|NCT01263470|147650669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||||TWO_SIDED|95.0|-27.8|-10.4||||||||-10.40|-27.80|
74048774|NCT01263470|147650670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||||TWO_SIDED|95.0|-24.19|-5.64||||||||-5.64|-24.19|
74048775|NCT01263470|147650670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.17|||||TWO_SIDED|95.0|-27.86|-12.48||||||||-12.48|-27.86|
74048776|NCT01263470|147650670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.07|||||TWO_SIDED|95.0|-30.41|-15.73||||||||-15.73|-30.41|
74048777|NCT01263470|147650670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.17|||||TWO_SIDED|95.0|-36.05|-20.29||||||||-20.29|-36.05|
74048778|NCT01263470|147650670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27|||||TWO_SIDED|95.0|-15.6|3.06||||||||3.06|-15.60|
74048779|NCT01263470|147650670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.52|||||TWO_SIDED|95.0|-19.41|-3.64||||||||-3.64|-19.41|
74048780|NCT01263470|147650670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.42|||||TWO_SIDED|95.0|-22.04|-6.8||||||||-6.80|-22.04|
74048781|NCT01263470|147650670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.52|||||TWO_SIDED|95.0|-27.61|-11.43||||||||-11.43|-27.61|
74048782|NCT01263470|147650671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.384|0.094||||||||0.094|-0.384|
74048783|NCT01263470|147650671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||||TWO_SIDED|95.0|-0.106|0.374||||||||0.374|-0.106|
74048784|NCT01263470|147650671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|||||TWO_SIDED|95.0|-0.103|0.39||||||||0.390|-0.103|
74048785|NCT01263470|147650671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|||||TWO_SIDED|95.0|-0.218|0.227||||||||0.227|-0.218|
74048786|NCT01263470|147650671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-0.241|0.245||||||||0.245|-0.241|
74048787|NCT01263470|147650671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|||||TWO_SIDED|95.0|0.038|0.524||||||||0.524|0.038|
74097971|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.44|1.1|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||1.10|0.44|
74097972|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.32|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.91|0.32|
74097973|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.45|1.32|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 10%|||1.32|0.45|
74097974|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.37|1.34|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||1.34|0.37|
74097975|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.26|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||0.91|0.26|
74097976|NCT01844505|147744552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.34|1.39|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline|||1.39|0.34|
74097977|NCT02304458|147744611|OTHER|Maximum Tolerate Dose Level was determined by the rolling-6 design.|Maximum Tolerate Dose Level|3.0|||||TWO_SIDED||||||||Maximum Tolerate Dose Level is 3 mg/kg Nivolumab|||||
74097978|NCT03395405|147744648|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.459|TWO_SIDED|95.0|0.33|1.64||No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.|Likelihood Ratio Test|The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.|HR estimated from a Cox model|The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.||1.64|0.33|0.459
74097979|NCT03395405|147744650|SUPERIORITY|||||||0.735||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.|ANCOVA|Titer values were log-transformed||Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.||||0.735
73880983|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0284|TWO_SIDED|95.0|1.11|6.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.97|1.11|0.0284
74048788|NCT01263470|147650671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|||||TWO_SIDED|95.0|0.041|0.54||||||||0.540|0.041|
73880984|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.72||||0.265|TWO_SIDED|95.0|0.66|4.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.45|0.66|0.2650
74048789|NCT01263470|147650671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|||||TWO_SIDED|95.0|-0.077|0.38||||||||0.380|-0.077|
74048790|NCT01263470|147650672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||||TWO_SIDED|95.0|-0.245|0.156||||||||0.156|-0.245|
74048791|NCT01263470|147650672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|||||TWO_SIDED|95.0|-0.185|0.21||||||||0.210|-0.185|
74048792|NCT01263470|147650672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|||||TWO_SIDED|95.0|-0.053|0.369||||||||0.369|-0.053|
74048793|NCT01263470|147650672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||||TWO_SIDED|95.0|-0.14|0.235||||||||0.235|-0.140|
74048794|NCT01263470|147650672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|||||TWO_SIDED|95.0|-0.097|0.341||||||||0.341|-0.097|
74048795|NCT01263470|147650672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|||||TWO_SIDED|95.0|-0.036|0.395||||||||0.395|-0.036|
74048796|NCT01263470|147650672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.325|||||TWO_SIDED|95.0|0.097|0.553||||||||0.553|0.097|
74048797|NCT01263470|147650672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|||||TWO_SIDED|95.0|0.006|0.423||||||||0.423|0.006|
74048798|NCT01263470|147650673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|||||TWO_SIDED|95.0|-0.444|0.209||||||||0.209|-0.444|
74048799|NCT01263470|147650673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.362|0.162||||||||0.162|-0.362|
74048800|NCT01263470|147650673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|||||TWO_SIDED|95.0|-0.166|0.324||||||||0.324|-0.166|
74048801|NCT01263470|147650673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|||||TWO_SIDED|95.0|-0.355|0.121||||||||0.121|-0.355|
74048802|NCT01263470|147650673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||||TWO_SIDED|95.0|-0.203|0.408||||||||0.408|-0.203|
74048803|NCT01263470|147650673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.124|0.364||||||||0.364|-0.124|
74048804|NCT01263470|147650673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|||||TWO_SIDED|95.0|0.071|0.526||||||||0.526|0.071|
74048805|NCT01263470|147650673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||||TWO_SIDED|95.0|-0.118|0.322||||||||0.322|-0.118|
74048806|NCT01263470|147650674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||||TWO_SIDED|95.0|-0.23|0.308||||||||0.308|-0.230|
74048807|NCT01263470|147650674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|||||TWO_SIDED|95.0|-0.029|0.379||||||||0.379|-0.029|
74048808|NCT01263470|147650674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|||||TWO_SIDED|95.0|0.044|0.453||||||||0.453|0.044|
74048809|NCT01263470|147650674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||||TWO_SIDED|95.0|-0.035|0.407||||||||0.407|-0.035|
74048810|NCT01263470|147650674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|||||TWO_SIDED|95.0|-0.236|0.34||||||||0.340|-0.236|
74048811|NCT01263470|147650674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|||||TWO_SIDED|95.0|-0.044|0.421||||||||0.421|-0.044|
74048812|NCT01263470|147650674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.261|||||TWO_SIDED|95.0|0.026|0.496||||||||0.496|0.026|
74048813|NCT01263470|147650674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|||||TWO_SIDED|95.0|-0.049|0.448||||||||0.448|-0.049|
74048814|NCT01263470|147650675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.85|||||TWO_SIDED|95.0|-38.75|-8.94||||||||-8.94|-38.75|
74048815|NCT01263470|147650675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.38|||||TWO_SIDED|95.0|-37.14|-9.61||||||||-9.61|-37.14|
74048816|NCT01263470|147650675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.6|||||TWO_SIDED|95.0|-53.18|-28.02||||||||-28.02|-53.18|
74048817|NCT01263470|147650675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.75|||||TWO_SIDED|95.0|-54.93|-30.58||||||||-30.58|-54.93|
74048818|NCT01263470|147650675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.36|||||TWO_SIDED|95.0|-19.7|8.98||||||||8.98|-19.70|
74048819|NCT01263470|147650675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.89|||||TWO_SIDED|95.0|-18.13|8.35||||||||8.35|-18.13|
74048820|NCT01263470|147650675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.11|||||TWO_SIDED|95.0|-34.22|-10.01||||||||-10.01|-34.22|
74048821|NCT01263470|147650675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.27|||||TWO_SIDED|95.0|-35.98|-12.55||||||||-12.55|-35.98|
74048822|NCT01263470|147650676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.31|||||TWO_SIDED|95.0|-80.79|-35.83||||||||-35.83|-80.79|
74048823|NCT01263470|147650676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.66|||||TWO_SIDED|95.0|-80.84|-40.47||||||||-40.47|-80.84|
74048824|NCT01263470|147650676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-78.72|||||TWO_SIDED|95.0|-97.03|-60.4||||||||-60.40|-97.03|
74048825|NCT01263470|147650676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-87.43|||||TWO_SIDED|95.0|-106.26|-68.6||||||||-68.60|-106.26|
74048826|NCT01263470|147650676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|||||TWO_SIDED|95.0|-24.69|19.23||||||||19.23|-24.69|
74048827|NCT01263470|147650676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07|||||TWO_SIDED|95.0|-24.85|14.7||||||||14.70|-24.85|
74048828|NCT01263470|147650676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.13|||||TWO_SIDED|95.0|-41.16|-5.11||||||||-5.11|-41.16|
74048829|NCT01263470|147650676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.84|||||TWO_SIDED|95.0|-50.36|-13.33||||||||-13.33|-50.36|
74048830|NCT01263470|147650677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.859|||||TWO_SIDED|95.0|-2.736|8.455||||||||8.455|-2.736|
74048831|NCT01263470|147650677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.456|||||TWO_SIDED|95.0|0.748|10.165||||||||10.165|0.748|
74048832|NCT01263470|147650677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.715|||||TWO_SIDED|95.0|3.181|12.248||||||||12.248|3.181|
74048833|NCT01263470|147650677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.557|||||TWO_SIDED|95.0|-3.763|8.877||||||||8.877|-3.763|
74048834|NCT01263470|147650677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.66|||||TWO_SIDED|95.0|7.924|21.396||||||||21.396|7.924|
74048835|NCT01263470|147650677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.257|||||TWO_SIDED|95.0|11.353|23.16||||||||23.160|11.353|
74048836|NCT01263470|147650677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.515|||||TWO_SIDED|95.0|13.629|25.401||||||||25.401|13.629|
74048837|NCT01263470|147650677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.357|||||TWO_SIDED|95.0|7.013|21.701||||||||21.701|7.013|
74048838|NCT01263470|147650678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.535|||||TWO_SIDED|95.0|-0.019|1.089||||||||1.089|-0.019|
74048839|NCT01263470|147650678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764|||||TWO_SIDED|95.0|0.214|1.315||||||||1.315|0.214|
74048840|NCT01263470|147650678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.999|||||TWO_SIDED|95.0|0.418|1.58||||||||1.580|0.418|
74048841|NCT01263470|147650678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.959|||||TWO_SIDED|95.0|0.43|1.489||||||||1.489|0.430|
74048842|NCT01263470|147650678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.934|||||TWO_SIDED|95.0|0.315|1.552||||||||1.552|0.315|
74097980|NCT03395405|147744654|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.873|TWO_SIDED|95.0|0.19|4.06||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Likelihood Ratio Test|||Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until first negative viral load between study arms, with a two-sided alternative.||4.06|0.19|0.873
74048843|NCT01263470|147650678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.163|||||TWO_SIDED|95.0|0.551|1.774||||||||1.774|0.551|
74048844|NCT01263470|147650678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.398|||||TWO_SIDED|95.0|0.759|2.036||||||||2.036|0.759|
74048845|NCT01263470|147650678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.358|||||TWO_SIDED|95.0|0.76|1.956||||||||1.956|0.760|
74048846|NCT01263470|147650679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.25|||||TWO_SIDED|95.0|-7.87|16.38||||||||16.38|-7.87|
74048847|NCT01263470|147650679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.26|||||TWO_SIDED|95.0|-0.9|23.42||||||||23.42|-0.90|
74048848|NCT01263470|147650679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||||TWO_SIDED|95.0|-10.56|16.95||||||||16.95|-10.56|
74048849|NCT01263470|147650679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|||||TWO_SIDED|95.0|-16.27|8.94||||||||8.94|-16.27|
74048850|NCT01263470|147650679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75|||||TWO_SIDED|95.0|-9.79|19.29||||||||19.29|-9.79|
74048851|NCT01263470|147650679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.76|||||TWO_SIDED|95.0|-2.67|26.19||||||||26.19|-2.67|
74048852|NCT01263470|147650679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69|||||TWO_SIDED|95.0|-12.02|19.4||||||||19.40|-12.02|
74048853|NCT01263470|147650679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.17|||||TWO_SIDED|95.0|-18.04|11.71||||||||11.71|-18.04|
74048854|NCT01029691|147650710|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||unadjusted systolic blood pressure at baseline between groups||||0.45
74048855|NCT01029691|147650710|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at baseline between groups||||0.66
74048856|NCT01029691|147650710|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Unadjusted systolic blood pressure at week 1||||0.61
74048857|NCT01029691|147650710|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at week 1||||0.75
74048858|NCT01029691|147650711|SUPERIORITY|||||||0.085|||||||Chi-squared|||||||0.085
74048859|NCT01029691|147650712|SUPERIORITY|||||||0.012||||||Unadjusted|t-test, 2 sided|||||||0.012
74048860|NCT01029691|147650716|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.4
74048861|NCT02723019|147650744|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||Analyzed using logistic regression analysis||||0.01
74048862|NCT02723019|147650745|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||||||0.19
74048863|NCT02723019|147650746|SUPERIORITY|||||||0.73||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.73
74048864|NCT02723019|147650747|SUPERIORITY|||||||0.28||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.28
74048865|NCT02723019|147650748|SUPERIORITY|||||||0.71||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.71
74048866|NCT02723019|147650749|SUPERIORITY|||||||0.42|||||||negative binomial regression model analy|||negative binomial regression model analysis||||0.42
74048867|NCT01099761|147650849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED||||||ANCOVA|||||||0.023
74048868|NCT01099761|147650849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED||||||ANCOVA|||||||0.012
74048869|NCT01099761|147650849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435|TWO_SIDED||||||ANCOVA|||||||0.435
74048870|NCT01099761|147650850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED||||||ANCOVA|||||||0.039
74097981|NCT00000378|147744666|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||actual calculation|Regression, Logistic|||logistic regression and mixed effects model||||<0.05
74097982|NCT04684238|147744675|OTHER|Least square means of the difference between the treatment groups, including a 2-sided 95% confidence interval was reported in the statistical analysis. The noninferiority criterion was a relative difference of less than 15% between treatment groups.|Least square means|6.57|||||TWO_SIDED|95.0|-8.99|22.13||Noninferiority was defined as the entire 95% CI for the difference being above the noninferiority margin for the relative difference of -15%. Testing the hypothesis of no difference between isoflurane and midazolam.|Mixed Models Analysis|||||22.13|-8.99|
74097983|NCT04684238|147744676|NON_INFERIORITY|The non-inferiority margin was set to a relative difference of -15%.|Least square means|5.34|||||TWO_SIDED|95.0|-10.48|21.17||Testing the hypothesis of no difference between isoflurane and midazolam.||||||21.17|-10.48|
74097984|NCT04684238|147744677|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0004|TWO_SIDED|95.0|-3.8|-1.1|||ANCOVA|||||-1.1|-3.8|0.0004
74097985|NCT04684238|147744678|SUPERIORITY|Results display comparison between isoflurane and midazolam and are based on an analysis of variance model with treatment group as fixed effect and baseline opioid dose as covariate.|Mean Difference (Final Values)|-0.77||||0.096|TWO_SIDED|95.0|-1.69|0.14|||ANCOVA|||||0.14|-1.69|0.096
74097986|NCT04684238|147744679|SUPERIORITY||Hazard Ratio (HR)|3.3||||0.0021|TWO_SIDED|95.0|1.54|7.07|||Regression, Cox|||Time to extubation||7.07|1.54|0.0021
74097987|NCT04684238|147744680|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.636|TWO_SIDED|95.0|-0.15|0.25|||ANOVA|||Spontaneous breathing efforts. Results display a comparison between isoflurane and midazolam and are based on a mixed effects analysis of variance model with treatment group as fixed effect.||0.25|-0.15|0.636
74097988|NCT04684238|147744681|SUPERIORITY|Results display comparison between isoflurane and midazolam and are based on a Wilcoxon ranksum test.||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Need for inotropic/vasopressor agent at ≤24 hours.||||0.55
74097989|NCT04684238|147744681|SUPERIORITY|||||||0.637|||||||Wilcoxon (Mann-Whitney)|||Need for inotropic/vasopressor agent at \>24 hours.||||0.637
74097990|NCT00110136|147744703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_DEVIATION|2.02||0.2629|TWO_SIDED|95.0|-2.36|0.74||Paired t-test; no adjustments for multiple comparisons|paired t-test||The difference is post minus pre so negative values represents fewer hot flashes after treatment.|Analysis of the change in hot flash frequency from baseline to four weeks; null hypothesis is no change.||0.74|-2.36|0.2629
74097991|NCT00110136|147744704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.37|STANDARD_DEVIATION|7.91||0.1365|TWO_SIDED|95.0|-10.45|1.72||Paired t-test; unadjusted for multiple comparisons.|paired t-test||Difference in hot flash score is post minus pre so a negative value represents a decrease in the frequency and/or severity of the hot flashes.|Assessment of the change in the hot flash score over time||1.72|-10.45|0.1365
74097992|NCT00110136|147744706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_DEVIATION|7.0||0.832|TWO_SIDED|95.0|-4.84|5.92||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in MCS from baseline to four weeks (post minus pre) so values greater than zero reflect improvement in QOL.|Assess the change in MCS from baseline to four weeks in patients receiving St. John's wort.||5.92|-4.84|0.8320
74097993|NCT00110136|147744707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|7.43||0.9995|TWO_SIDED|95.0|-5.71|5.71||Paired t-test on the change in PCS from baseline to four weeks; unadjusted for multiple comparisons.|paired t-test||This is the change in PCS from baseline to four weeks (post minus pre), so positive numbers represent improvement in QOL.|Assess the change in PCS from baseline to four weeks; null hypothesis is no change.||5.71|-5.71|0.9995
74097994|NCT00110136|147744708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.35|STANDARD_DEVIATION|7.12||0.1042|TWO_SIDED|95.0|-1.12|9.822||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in mood from baseline to four weeks (post minus pre). Mood is scored so that higher numbers represent better mood so positive changes represent an improvement in mood.|Assess the change in mood from baseline to four weeks. Null hypothesis is no change.||9.822|-1.12|0.1042
74097995|NCT04540406|147744712|OTHER|We employed covariate-adjusted Principal Coordinates Analysis and a subject-stratified PERMANOVA test to assess the overall gut microbiota structural change. These tests are generally neither superiority, non-inferiority, nor equivalence tests. Instead, they are used to detect and evaluate overall differences in the microbial community structure between groups or conditions.||||||||||||||||PCoA (Principal Coordinates Analysis) + PERMANOVA (Permutational Multivariate Analysis of Variance) are exploratory multivariate techniques commonly used in microbiome research to assess and visualize differences in community composition. The null hypothesis for PERMANOVA is that there are no differences in the centroids (multivariate means) of the groups being compared. The microbial communities in different groups or conditions are not significantly different from each other.|To assess the overall structural changes in gut microbiota, we employed covariate-adjusted Principal Coordinates Analysis (PCoA) and a subject-stratified PERMANOVA test. PCoA, an exploratory multivariate technique, helps visualize and interpret patterns in complex microbiome data by reducing dimensionality, with the first principal coordinate (PC1) capturing the largest variation among samples. PERMANOVA, which does not rely on standard parametric assumptions, was used to determine if there are statistically significant differences in the overall composition of microbial communities between groups based on a chosen distance metric. Our analysis aimed to explore whether microbial community compositions differed significantly between Day 0 and Day 28 within the Treatment group, accounting for inter-individual variability. Similarly, we investigated if such differences existed over the same time points in the Control group. The unit of measure was distance metrics.|||
74097996|NCT03400943|147744726|SUPERIORITY||Risk Difference (RD)|0.56|||<|0.0001|TWO_SIDED|95.0|0.33|0.78|||Cochran-Mantel-Haenszel||Number of subjects per treatment: 41 (Vilaprisan) / 20 (Placebo).|Vilaprisan (A1) and Vilaprisan+Placebo (B2) combined vs. Placebo+Vilaprisan (B1) in treatment period 1||0.78|0.33|<.0001
73888104|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|16.4||||0.1557|TWO_SIDED|95.0|-6.3|39.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.1|-6.3|0.1557
74048871|NCT03398824|147650869|OTHER|Fanconi Anemia is a rare disease. Therefore, the primary end point of the study was to assess the proportion of subjects with a HR during 6 months of metformin treatment; sample size was calculated assuming that a HR rate \< 20% suggests preliminary efficacy of treatment that warranted additional investigation and, conversely, that the study should be deemed futile if the rate of HR was \<5%.|response rate|30.8|||||TWO_SIDED|90.0|11.3|57.3|||||||Fanconi Anemia is a rare disease. Therefore, the primary end point of the study was to assess the proportion of subjects with a HR during 6 months of metformin treatment; sample size was calculated assuming that a HR rate \>20% suggests preliminary efficacy of treatment that warranted additional investigation and, conversely, that the study should be deemed futile if the rate of HR was \<5%.|57.3|11.3|
74097997|NCT02563106|147744733|OTHER|The analysis of the primary endpoint was based on the mITT analysis set. Per-protocol and worse case analyses were performed as sensitivity analyses.The P-value was based on a one-sided z-test for the comparison of the treatment difference between the SYN-004 group and the Placebo group.|Relative Risk Reduction (%)|71.4||||0.045|TWO_SIDED|95.0|-35.9|94.0||Study was designed to provide 80% power to detect treatment effect with one-sided alpha = 0.05 on the primary endpoint. Based on the pre-specified z-test the one-sided P=0.045.|z-test|1-sided P=0.045.|Relative Risk Reduction in SYN-004 group compared to Placebo group.|The Modified Intent-to-Treat (mITT) analysis set included randomized subjects who received at least 1 dose of study drug. Number of subjects with CDI, imputing early termination without CDI as not being treatment failures.||94.0|-35.9|0.045
74097998|NCT04091659|147744736|EQUIVALENCE|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|-0.18||||0.65|TWO_SIDED|95.0|-0.85|0.49|||SEM||||The control group, standard education was the reference for this model.|0.49|-0.85|0.65
74048872|NCT01045551|147650890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.98|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|t-test, 2 sided|||||||0.98
74048873|NCT01045551|147650891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_DEVIATION|0.9024|||TWO_SIDED|||||||||||||
74048874|NCT04337203|147650904|OTHER|Feasibility study and calculated confidence interval.||||||0.54|||||||Independent samples proportions test|||||||0.54
74048875|NCT01682759|147650930|NON_INFERIORITY_OR_EQUIVALENCE|Omarigliptin was considered non-inferior to glimepiride if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference in least-squares (LS) means for change from baseline in A1C at Week 54 (omarigliptin vs. glimepiride) was lower than 0.35%.|Difference in the least squares means|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||Constrained longitudinal data analysis (cLDA) model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|||0.30|0.06|
74048876|NCT01682759|147650931|SUPERIORITY_OR_OTHER||Difference in percentages|-6.9|||||TWO_SIDED|95.0|-13.9|0.1|||||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||0.1|-13.9|
74048877|NCT01682759|147650932|SUPERIORITY_OR_OTHER||Difference in percentages|1.1|||||TWO_SIDED|95.0|-1.6|3.8|||||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||3.8|-1.6|
74048878|NCT01682759|147650933|SUPERIORITY_OR_OTHER||Difference in the least squares means|5.6|||||TWO_SIDED|95.0|0.1|11.2|||||cLDA model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups|||11.2|0.1|
74048879|NCT01682759|147650934|SUPERIORITY_OR_OTHER||Between-group Rate Difference (%)|-3.7|||||TWO_SIDED|95.0|-10.6|3.3|||||Between-group CIs are calculated via Miettinen \& Nurminen method.|A1C \<6.5%||3.3|-10.6|
74048880|NCT01682759|147650935|SUPERIORITY_OR_OTHER||Difference in percentages|-21.3|||<|0.001|TWO_SIDED|95.0|-26.5|-16.4|||Difference in percentages||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||-16.4|-26.5|<0.001
74048881|NCT01682759|147650936|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.9|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Difference in the least squares means||cLDA model including terms for treatment, time, and the interaction of time by treatment with the constraint that the mean baseline is the same for all treatment groups.|||-1.4|-2.5|<0.001
74048882|NCT01682759|147650937|SUPERIORITY_OR_OTHER||Between-group Rate Difference|-10.3|||||TWO_SIDED|95.0|-17.8|-2.8|||||Between-group CIs are calculated via Miettinen \& Nurminen method.|A1C \< 7.0%||-2.8|-17.8|
74048883|NCT03650387|147650963|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
74048884|NCT03650387|147650964|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
74048885|NCT03650387|147650965|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
74048886|NCT02425891|147650977|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.8||||0.0025|TWO_SIDED|95.0|0.69|0.92|||Log Rank|||||0.92|0.69|0.0025
74048887|NCT02425891|147650978|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78|||Log Rank|||||0.78|0.49|<.0001
74048888|NCT02425891|147650979|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.87||||0.077|TWO_SIDED|95.0|0.75|1.02|||Log Rank|||||1.02|0.75|0.0770
74048889|NCT02425891|147650980|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.67||||0.0016|TWO_SIDED|95.0|0.53|0.86|||Log Rank|||||0.86|0.53|0.0016
74048890|NCT02425891|147650981|SUPERIORITY|Stratified Analysis|Difference in Overall Response Rates|10.12||||0.0021|TWO_SIDED|95.0|3.4|16.84|||Cochran-Mantel-Haenszel|||||16.84|3.40|0.0021
74048891|NCT02425891|147650982|SUPERIORITY|Stratified Analysis|Difference in Overall Response Rates|16.3||||0.0016|TWO_SIDED|95.0|5.67|26.92|||Cochran-Mantel-Haenszel|||||26.92|5.67|0.0016
74048892|NCT02425891|147650983|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.78||||0.0285|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.0285
74048893|NCT02425891|147650984|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.6||||0.0047|TWO_SIDED|95.0|0.43|0.86|||Log Rank|||||0.86|0.43|0.0047
74048894|NCT02425891|147650985|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.98||||0.8078|TWO_SIDED|95.0|0.81|1.18|||Log Rank|||||1.18|0.81|0.8078
74097999|NCT04091659|147744737|EQUIVALENCE|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|0.26||||0.02|TWO_SIDED|95.0|0.02|0.5|||SEM||The control group, standard education, was the reference|||0.50|0.02|0.02
74048895|NCT02425891|147650986|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.98||||0.8879|TWO_SIDED|95.0|0.73|1.31|||Log Rank|||||1.31|0.73|0.8879
74048898|NCT02943577|147651024|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.2398|TWO_SIDED|95.0|-2.7|0.68|||Mixed Model Repeated Measures (MMRM)|||||0.68|-2.70|0.2398
74048899|NCT02943577|147651025|SUPERIORITY||Least Squares Mean Difference|0.4||||0.5522|TWO_SIDED|95.0|-0.95|1.77|||Mixed Model Repeated Measures (MMRM)|||||1.77|-0.95|0.5522
74048900|NCT02943577|147651026|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9901|TWO_SIDED|95.0|-2.01|1.99|||Mixed Model Repeated Measures (MMRM)|||||1.99|-2.01|0.9901
74048901|NCT02943577|147651027|SUPERIORITY||Least Squares Mean Difference|0.5||||0.5563|TWO_SIDED|95.0|-1.17|2.17|||Mixed Model Repeated Measures (MMRM)|||||2.17|-1.17|0.5563
74098000|NCT04005352|147744793|SUPERIORITY||||||<|0.0001|ONE_SIDED|||||with significance level of 0.025|Wilcoxon (Mann-Whitney)|||||||<0.0001
74048902|NCT01355224|147651028|SUPERIORITY_OR_OTHER|||||||0.015|||||||Regression, Linear|Adjusted for age, gender, BMI, baseline intention.||||||.0150
74048903|NCT01355224|147651029|SUPERIORITY_OR_OTHER|||||||0.0365|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.||||||0.0365
74048904|NCT01355224|147651030|SUPERIORITY_OR_OTHER|||||||0.0622|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.||||||0.0622
74048905|NCT04437511|147651048|SUPERIORITY||LS Mean change difference (Final Values)|2.92|STANDARD_ERROR_OF_MEAN|0.72|<|0.001|TWO_SIDED|95.0|1.508|4.331|||Mixed Models Analysis|||||4.331|1.508|<0.001
74048906|NCT04437511|147651049|SUPERIORITY||LS Mean change difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.883|4.618|||Mixed Models Analysis|||||4.618|1.883|<0.001
74048907|NCT04437511|147651050|SUPERIORITY||LS Mean change difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.19||0.012|TWO_SIDED|95.0|0.104|0.841|||Mixed Models Analysis|||||0.841|0.104|0.012
74048908|NCT04437511|147651051|SUPERIORITY||LS Mean change difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.2||0.016|TWO_SIDED|95.0|0.089|0.868|||Mixed Models Analysis|||||0.868|0.089|0.016
74048909|NCT04437511|147651052|SUPERIORITY||LS Mean change difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.39||0.0006|TWO_SIDED|95.0|-2.086|-0.565|||Mixed Models Analysis|||||-0.565|-2.086|0.0006
74048910|NCT04437511|147651053|SUPERIORITY||LS Mean change difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.25|-0.794|||Mixed Models Analysis|||||-0.794|-2.250|<0.001
74048911|NCT04437511|147651054|SUPERIORITY||LS Mean change difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.127|<|0.001|TWO_SIDED|95.0|-0.95|-0.45|||Mixed Models Analysis|||||-0.45|-0.95|<0.001
74048912|NCT04437511|147651055|SUPERIORITY||LS Mean change difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.95|-0.4|||Mixed Models Analysis|||||-0.40|-0.95|<0.001
74048913|NCT04437511|147651056|SUPERIORITY||LS Mean change difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.44||0.0001|TWO_SIDED|95.0|0.84|2.566|||Mixed Models Analysis|||||2.566|0.840|0.0001
74048914|NCT04437511|147651057|SUPERIORITY||LS Mean change difference (Final Values)|1.83|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|0.913|2.748|||Mixed Models Analysis|||||2.748|0.913|<0.001
74048915|NCT04437511|147651058|SUPERIORITY||LS Mean change difference (Final Values)|-86.37|STANDARD_ERROR_OF_MEAN|1.275|<|0.0001|TWO_SIDED|95.0|-88.87|-83.87|||Mixed Models Analysis|||||-83.87|-88.87|<0.0001
74048916|NCT04437511|147651059|SUPERIORITY||LS Mean change difference (Final Values)|-0.0041||||0.4522|TWO_SIDED|95.0|-0.0148|0.0066|||ANCOVA|||||0.0066|-0.0148|0.4522
74048917|NCT04437511|147651060|SUPERIORITY||LS Mean change difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.007||0.002|TWO_SIDED|95.0|0.01|0.04|||Mixed Models Analysis|||Bilateral Hippocampus||0.04|0.01|0.002
74048918|NCT04437511|147651060|SUPERIORITY||LS Mean change difference (Final Values)|-6.66|STANDARD_ERROR_OF_MEAN|0.561|<|0.001|TWO_SIDED|95.0|-7.76|-5.56|||Mixed Models Analysis|||Bilateral Whole Brain||-5.56|-7.76|<0.001
74048919|NCT04437511|147651060|SUPERIORITY||LS Mean change difference (Final Values)|3.02|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|2.52|3.52|||Mixed Models Analysis|||Bilateral Ventricles||3.52|2.52|<0.001
74048920|NCT04654468|147651068|SUPERIORITY||||||<|0.0001|||||||Paired McNemar|||Percentage of participants who achieved TA from baseline through Week 25 were compared with the percentage of participants who reported TA within 24 weeks prior to screening.||||<.0001
74048921|NCT05564039|147651108|SUPERIORITY||LS Mean difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.69|||Mixed Models Analysis|||||-0.69|-1.10|<0.0001
74048922|NCT05564039|147651109|SUPERIORITY||LS Mean difference (Final Values)|-7.4|||<|0.0001|TWO_SIDED|95.0|-8.7|-6.0|||Mixed Models Analysis|||||-6.0|-8.7|<.0001
74048923|NCT05564039|147651110|SUPERIORITY||Odds Ratio (OR)|7.13|||<|0.0001|TWO_SIDED|95.0|3.82|13.32|||Regression, Logistic|||||13.32|3.82|<0.0001
74048924|NCT05564039|147651111|SUPERIORITY||Odds Ratio (OR)|12.24|||<|0.0001|TWO_SIDED|95.0|6.51|23.02|||Regression, Logistic|||||23.02|6.51|<0.0001
74048925|NCT05564039|147651112|SUPERIORITY||Odds Ratio (OR)|15.34|||<|0.0001|TWO_SIDED|95.0|4.58|51.36|||Regression, Logistic|||||51.36|4.58|<0.0001
74048926|NCT05564039|147651113|SUPERIORITY||Odds Ratio (OR)|9.31|||<|0.0001|TWO_SIDED|95.0|5.11|16.98|||Regression, Logistic|||||16.98|5.11|<0.0001
74048927|NCT05564039|147651114|SUPERIORITY||Odds Ratio (OR)|19.35|||<|0.0001|TWO_SIDED|95.0|9.07|41.3|||Regression, Logistic|||||41.30|9.07|<0.0001
74048928|NCT05564039|147651115|SUPERIORITY||Odds Ratio (OR)|35.83|||<|0.0001|TWO_SIDED|95.0|7.18|178.89|||Regression, Logistic|||||178.89|7.18|<0.0001
74048929|NCT05564039|147651116|SUPERIORITY||Odds Ratio (OR)|20.44|||<|0.0001|TWO_SIDED|95.0|8.4|49.77|||Regression, Logistic|||||49.77|8.40|<0.0001
74048930|NCT05564039|147651117|SUPERIORITY||LS Mean difference (Final Values)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.32|-0.49|||ANCOVA|||||-0.49|-1.32|<0.001
74098001|NCT04005352|147744794|NON_INFERIORITY|4 letter margin (1-sided)|Difference|0.1|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-1.3|1.5|||ANOVA|||||1.5|-1.3|<0.0001
74098002|NCT04005352|147744795|SUPERIORITY||||||<|0.0001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74098003|NCT04005352|147744796|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74098004|NCT04005352|147744797|SUPERIORITY|Week 14|Odds Ratio (OR)|1.6||||0.051|TWO_SIDED|95.0|0.9|2.7|||likelihood ratio test|Assessed at one-sided 0.025 significance level||||2.7|0.9|0.0510
74098005|NCT04005352|147744797|SUPERIORITY|Week 16|Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.7|3.9|||likelihood ratio test|Assessed at one-sided 0.025 significance level||||3.9|1.7|<0.0001
74098006|NCT04005352|147744800|SUPERIORITY||Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.84||0.8137|TWO_SIDED|95.0|-1.9|1.5||p-value for treatment difference|ANOVA|||||1.5|-1.9|0.8137
74048931|NCT05564039|147651118|SUPERIORITY||LS Mean difference (Final Values)|-5.1||||0.0002|TWO_SIDED|95.0|-7.8|-2.5|||Mixed Models Analysis|||||-2.5|-7.8|0.0002
74048932|NCT05564039|147651119|SUPERIORITY||LS Mean difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.1|-2.1|||Mixed Models Analysis|||||-2.1|-3.1|<0.0001
74048933|NCT05564039|147651120|SUPERIORITY||LS Mean difference (Final Values)|4.1||||0.1181|TWO_SIDED|95.0|-1.0|9.2|||ANCOVA|||||9.2|-1.0|0.1181
74048934|NCT02421939|147651121|OTHER||Hazard Ratio (HR)|0.637||||0.0004|TWO_SIDED|95.0|0.49|0.83||1-sided P-value|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm|Stratified analysis where tratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.||0.830|0.490|0.0004
74048935|NCT02421939|147651123|OTHER||Hazard Ratio (HR)|0.793||||0.0415|TWO_SIDED|95.0|0.577|1.089||1-sided P-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT||1.089|0.577|0.0415
74048936|NCT02421939|147651124|OTHER||Adjusted Treatment Difference|10.6||||0.0106|TWO_SIDED|95.0|2.8|18.4||Stratified P-value|Cochran-Mantel-Haenszel|||Based on stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Treatment difference = gilteritinib -chemotherapy.||18.4|2.8|0.0106
74048937|NCT02421939|147651125|OTHER||Hazard Ratio (HR)|0.889||||0.6654|TWO_SIDED|95.0|0.506|1.563||Unstratified p-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|The LFS was analyzed for participants who achieved remission using the stratified log-rank test with strata to control for response to first-line AML therapy and preselected salvage chemotherapy. Duration of LFS was based on Kaplan-Meier estimates.||1.563|0.506|0.6654
74048938|NCT02421939|147651126|OTHER||Hazard Ratio (HR)|0.206||||0.1189|TWO_SIDED|95.0|0.022|1.886||Unstratified|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm.|||1.886|0.022|0.1189
74048939|NCT02421939|147651127|OTHER||Treatment difference|32.5|||<|0.0001|TWO_SIDED|95.0|22.3|42.6||Unstratified 2-sided P-value|2-sided Fisher's exact test|||Treatment difference = gilteritinib - chemotherapy. The 95% CIs were asymptotic confidence limits using the normal approximation to the binomial distribution.||42.6|22.3|<0.0001
74048940|NCT02421939|147651128|OTHER||Treatment Difference|10.2||||0.0333|TWO_SIDED|95.0|1.2|19.1||Unstratified 2-sided P-value.|2-sided Fisher's exact test|Treatment difference = gilteritinib - chemotherapy.||||19.1|1.2|0.0333
74048941|NCT02421939|147651129|OTHER||Least Squares Mean Difference|-1.2567||||0|||||||ANCOVA|||C1D8: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.||||0.0000
74098007|NCT04005352|147744801|SUPERIORITY|Week 32|Odds Ratio (OR)|1.0||||0.4106|TWO_SIDED|95.0|0.7|1.3|||likelihood ratio test|adjusting for baseline BCVA categories (\<55, 55-\<73, ≥73 letters).||||1.3|0.7|0.4106
74098008|NCT04005352|147744801|SUPERIORITY|Week 64|Odds Ratio (OR)|1.0||||0.4667|TWO_SIDED|95.0|0.7|1.4|||likelihood ratio test|adjusting for baseline BCVA categories (\<55, 55-\<73, ≥73 letters).||||1.4|0.7|0.4667
74098009|NCT04005352|147744802|SUPERIORITY|Week 32|Odds Ratio (OR)|1.1||||0.2397|TWO_SIDED|95.0|0.8|1.7|||likelihood ratio test|assessed at the 0.025 significance level||||1.7|0.8|0.2397
74098010|NCT04005352|147744802|SUPERIORITY|Week 64|Odds Ratio (OR)|1.2||||0.115|TWO_SIDED|95.0|0.9|1.8|||likelihood ratio test|assessed at the 0.025 significance level||||1.8|0.9|0.1150
74098011|NCT04005352|147744803|SUPERIORITY|Weeks 28 and 32|Difference|-26.9|STANDARD_ERROR_OF_MEAN|9.87||0.0066|TWO_SIDED|95.0|-46.3|-7.5|||ANOVA|||||-7.5|-46.3|0.0066
74098012|NCT04005352|147744803|SUPERIORITY|Weeks 60 and 64|Difference|-15.4|STANDARD_ERROR_OF_MEAN|11.26||0.1714|TWO_SIDED|95.0|-37.6|6.7|||ANOVA|||||6.7|-37.6|0.1714
74098013|NCT04005352|147744806|SUPERIORITY|Week 32|LS Mean Difference|0.37||||0.193|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||||0.9|-0.2|0.193
74048942|NCT02421939|147651129|OTHER||Least Squares Mean Difference|0.1574||||0.8037|||||||ANCOVA|||C2D1: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.||||0.8037
74048943|NCT02421939|147651130|OTHER||Adjusted Treatment Difference,|18.6|||<|0.0171|TWO_SIDED|95.0|9.8|27.4||Stratified 1-sided P-value.|Cochran-Mantel-Haenszel|||Based on a stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Pooled strata were used as shown in Table 12.3.3.2. Treatment differences were adjusted based on pooled strata. Treatment difference = gilteritinib 120 mg - chemotherapy.||27.4|9.8|<0.0171
74048944|NCT04453722|147651133|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-0.1||||0.12|TWO_SIDED|95.0|-0.4|0.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital TWA SpO2 \<90% (%)||0|-0.4|0.120
74048945|NCT04453722|147651133|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test|Median Difference (Final Values)|-407.0||||0.349|TWO_SIDED|95.0|-1816.0|208.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital AUC SpO2 \<90% (% \* min)||208|-1816|0.349
74048946|NCT04453722|147651133|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.2|0.0|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge TWA SpO2 \<90% (%)||0|-0.2|0.307
74048947|NCT04453722|147651133|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-35.0||||0.431|TWO_SIDED|95.0|-195.0|67.0|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge AUC SpO2 \<90% (% \* min)||67|-195|0.431
74048948|NCT04453722|147651134|SUPERIORITY||Risk Ratio (RR)|0.96|||>|0.99|TWO_SIDED|95.0|0.22|4.27|||Fisher Exact|||variable: In hospital Any event, N (%)c||4.27|0.22|>0.99
74048949|NCT04453722|147651134|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.35|2.9|||Chi-squared|||variable: Post-discharge Any event, N (%)||2.90|0.35|>0.99
74048950|NCT04453722|147651135|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-6.0||||0.354|TWO_SIDED|95.0|-26.0|4.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital Number||4.0|-26.0|0.354
74048951|NCT04453722|147651135|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-46.1||||0.133|TWO_SIDED|95.0|-274.0|5.1|||Wilcoxon (Mann-Whitney)|||variable: In hospital Total duration (min)||5.1|-274|0.133
74048952|NCT04453722|147651135|SUPERIORITY||Median Difference (Final Values)|-24.1||||0.075|TWO_SIDED|95.0|-213.0|0.1|||Wilcoxon (Mann-Whitney)|||variable: In hospital Duration \>2 min (min)||0.1|-213|0.075
74098014|NCT04005352|147744806|SUPERIORITY|Week 64|LS Mean Difference|-2.0||||0.052|TWO_SIDED|95.0|-3.9|0.0|||ANCOVA|||||0.0|-3.9|0.052
74098015|NCT04005352|147744807|SUPERIORITY|Week 32|LS Mean Difference|2.16||||0.081|TWO_SIDED|95.0|-0.3|4.6|||ANCOVA|||||4.6|-0.3|0.081
74098016|NCT04005352|147744807|SUPERIORITY|Week 64|LS Mean Difference|-0.7||||0.59|TWO_SIDED|95.0|-3.2|1.8|||ANCOVA|||||1.8|-3.2|0.590
74048953|NCT04453722|147651135|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.009|TWO_SIDED|95.0|-4.5|-0.4|||Wilcoxon (Mann-Whitney)|||variable: In hospital Mean duration-all patients (min)||-0.4|-4.5|0.009
74048954|NCT04453722|147651135|SUPERIORITY||Median Difference (Final Values)|-2.2||||0.001|TWO_SIDED|95.0|-4.7|-0.7|||Wilcoxon (Mann-Whitney)|||variable: in hospital mean duration for events in those with any events (min)||-0.7|-4.7|0.001
74048955|NCT04453722|147651135|SUPERIORITY||Median Difference (Final Values)|0.0||||0.584|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: post-discharge number||1.0|-4.0|0.584
74048956|NCT04453722|147651135|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-1.3||||0.556|TWO_SIDED|95.0|-18.6|3.3|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge duration (min)||3.3|-18.6|0.556
74048957|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.096|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing daily life except sleep (at the day of discharge)||2.0|0.0|0.096
74048958|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.205|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing sleep (at the day of discharge)||2.0|0.0|0.205
74048959|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.839|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: comfortable to wear (at the day of discharge)||0.0|-1.0|0.839
74048960|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.621|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert (at the day of discharge)||0.0|0.0|0.621
74048961|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.898|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to tactile alert||1.0|-1.0|0.898
74048962|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.654|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: easily cleaned/disinfected (at the day of discharge)||0.0|0.0|0.654
74098017|NCT04005352|147744808|SUPERIORITY|Week 32|LS Mean Difference|0.77||||0.558|TWO_SIDED|95.0|-1.8|3.4|||ANCOVA|||||3.4|-1.8|0.558
74098018|NCT04005352|147744808|SUPERIORITY|Week 64|LS Mean Difference|-1.9||||0.138|TWO_SIDED|95.0|-4.5|0.6|||ANCOVA|||||0.6|-4.5|0.138
73880985|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1238|TWO_SIDED|95.0|0.82|5.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.38|0.82|0.1238
73880986|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0219|TWO_SIDED|95.0|1.18|8.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.74|1.18|0.0219
74048963|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.929|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: adequate battery life (at the day of discharge)||1.0|-1.0|0.929
74048964|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.2|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Satisfy with the electrode patch (at the day of discharge)||0.0|-1.0|0.200
74048965|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.987|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study (at the day of discharge)||0.0|0.0|0.987
74048966|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.581|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Disturb IV line (at the day of discharge)||0.0|-1.0|0.581
74048967|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.18|TWO_SIDED|95.0|0.0|3.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing daily life except sleep (after 24 hours of discharge)||3.0|0.0|0.180
74048968|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.171|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: degree of distributing sleep (after 24 hours of discharge)||2.0|0.0|0.171
74048969|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.074|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert (after 24 hours of discharge)||0.0|-1.0|0.074
74048970|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.414|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to tactile alert (after 24 hours of discharge)||1.0|-2.0|0.414
74048971|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.506|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Easily cleaned/disinfected (after 24 hours of discharge)||0.0|0.0|0.506
74048972|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.747|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Adequate battery life (after 24 hours of discharge)||0.0|-1.0|0.747
74048973|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|-1.0||||0.023|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: satisfy with the electrode patch (after 24 hours of discharge)||0.0|-2.0|0.023
74048974|NCT04453722|147651138|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.023|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study (after 24 hours of discharge)||0.0|-1.0|0.023
74048975|NCT04453722|147651139|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.73|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Degree of disturbing routine work||0.0|-1.0|0.73
74048976|NCT04453722|147651139|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.097|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||Easily cleaned/disinfected||1.0|0.0|0.097
74048977|NCT04453722|147651139|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|1.0||||0.02|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Adequate battery life||1.0|0.0|0.02
74098019|NCT04005352|147744809|SUPERIORITY|Week 32|LS Mean Difference|1.6||||0.287|TWO_SIDED|95.0|-1.4|4.6|||ANCOVA|||||4.6|-1.4|0.287
74098020|NCT04005352|147744809|SUPERIORITY|Week 64|LS Mean Difference|-3.0||||0.07|TWO_SIDED|95.0|-6.2|0.2|||ANCOVA|||||0.2|-6.2|0.070
74098021|NCT04005352|147744810|SUPERIORITY|Week 32|LS Mean Difference|-0.71||||0.602|TWO_SIDED|95.0|-3.4|2.0|||ANCOVA|||||2.0|-3.4|0.602
74098022|NCT04005352|147744810|SUPERIORITY|Week 64|LS Mean Difference|-2.5||||0.086|TWO_SIDED|95.0|-5.3|0.4|||ANCOVA|||||0.4|-5.3|0.086
74098023|NCT04005352|147744811|SUPERIORITY|Week 32|LS Mean Difference|1.55||||0.174|TWO_SIDED|95.0|-0.7|3.8|||ANCOVA|||||3.8|-0.7|0.174
74098024|NCT04005352|147744811|SUPERIORITY|Week 64|LS Mean Difference|-1.5||||0.21|TWO_SIDED|95.0|-3.8|0.8|||ANCOVA|||||0.8|-3.8|0.210
73880987|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|5.46||||0.0022|TWO_SIDED|95.0|1.84|16.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.16|1.84|0.0022
74048978|NCT04453722|147651139|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.037|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Satisfy with the electrode patch||1.0|0.0|0.037
74048979|NCT04453722|147651139|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.482|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert||1.0|-2.0|0.482
74098025|NCT04005352|147744812|SUPERIORITY|Week 32|LS Mean Difference|-0.96||||0.499|TWO_SIDED|95.0|-3.8|1.8|||ANCOVA|||||1.8|-3.8|0.499
74048980|NCT04453722|147651139|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.031|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study||1.0|0.0|0.031
74098026|NCT04005352|147744812|SUPERIORITY|Week 64|LS Mean Difference|-2.3||||0.147|TWO_SIDED|95.0|-5.4|0.8|||ANCOVA|||||0.8|-5.4|0.147
74098027|NCT04005352|147744813|SUPERIORITY|Week 32|LS Mean Difference|0.88||||0.643|TWO_SIDED|95.0|-2.8|4.6|||ANCOVA|||||4.6|-2.8|0.643
74048981|NCT04453722|147651139|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.947|TWO_SIDED|95.0|0.0|1.0||variable: Patients' complaint about the device|Wilcoxon (Mann-Whitney)|||variable: Patients' complaint about the device||1.0|0.0|0.947
74048982|NCT04453722|147651139|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.324|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Disturb IV line||0.0|0.0|0.324
74048983|NCT00137267|147651204|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
74048984|NCT00137267|147651205|SUPERIORITY_OR_OTHER|||||||0.152|TWO_SIDED||||||Chi-squared|||||||0.152
74048985|NCT01553591|147651305|SUPERIORITY|||||||0.014||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.014
74098028|NCT04005352|147744813|SUPERIORITY|Week 64|LS Mean Difference|-1.3||||0.507|TWO_SIDED|95.0|-5.0|2.5|||ANCOVA|||||2.5|-5.0|0.507
74098029|NCT04005352|147744814|SUPERIORITY|Week 32|LS Mean Difference|0.49||||0.7|TWO_SIDED|95.0|-2.0|3.0|||ANCOVA|||||3.0|-2.0|0.700
74098030|NCT04005352|147744814|SUPERIORITY|Week 64|LS Mean Difference|-2.9||||0.07|TWO_SIDED|95.0|-6.0|0.2|||ANCOVA|||||0.2|-6.0|0.070
74098031|NCT04005352|147744815|SUPERIORITY|Week 32|LS Mean Difference|0.73||||0.741|TWO_SIDED|95.0|-3.6|5.1|||ANCOVA|||||5.1|-3.6|0.741
74098032|NCT04005352|147744815|SUPERIORITY|Week 64|LS Mean Difference|-1.7||||0.494|TWO_SIDED|95.0|-6.6|3.2|||ANCOVA|||||3.2|-6.6|0.494
74098033|NCT04005352|147744816|SUPERIORITY|Week 32|LS Mean Difference|1.76||||0.054|TWO_SIDED|95.0|0.0|3.5|||ANCOVA|||||3.5|-0.0|0.054
74098034|NCT04005352|147744816|SUPERIORITY|Week 64|LS Mean Difference|-1.1||||0.331|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|||||1.2|-3.4|0.331
74098035|NCT04005352|147744817|SUPERIORITY|Week 32|LS Mean Difference|1.24||||0.394|TWO_SIDED|95.0|-1.6|4.1|||ANCOVA|||||4.1|-1.6|0.394
74048986|NCT01553591|147651305|SUPERIORITY|||||||0.004||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.004
73880988|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.82||||0.223|TWO_SIDED|95.0|0.69|4.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.77|0.69|0.2230
73880989|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0018|TWO_SIDED|95.0|1.83|13.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.97|1.83|0.0018
73880990|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0205|TWO_SIDED|95.0|1.19|8.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.42|1.19|0.0205
74098036|NCT04005352|147744817|SUPERIORITY|Week 64|LS Mean Difference|-0.5||||0.728|TWO_SIDED|95.0|-3.6|2.5|||ANCOVA|||||2.5|-3.6|0.728
73880991|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4628|TWO_SIDED|95.0|0.54|3.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.81|0.54|0.4628
73880992|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.51||||0.4015|TWO_SIDED|95.0|0.58|3.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.92|0.58|0.4015
73880993|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0031|TWO_SIDED|95.0|1.76|16.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.47|1.76|0.0031
74048987|NCT01553591|147651306|SUPERIORITY|||||||0.112||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.112
74048988|NCT01553591|147651306|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
74048989|NCT00397631|147651443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.12|<|0.001||95.0|-1.13|-0.65|||ANCOVA|Model terms: treatment, baseline HbA1c||||-0.65|-1.13|<0.001
74098037|NCT06017479|147744820|OTHER|"Chi-square test as the study used chi-square analysis to compare the incidence of UTIs between the groups (p = 0.660) For this non-inferiority analysis, the study demonstrated that the odds ratio (OR) between the two groups was 0.8 (95% CI: 0.4-1.95), indicating no significant difference. Further details are provided in the study's discussion section."|Odds Ratio (OR)|0.8|STANDARD_DEVIATION|18.125||0.66|TWO_SIDED|95.0|0.4|1.95||The p-value was not adjusted for multiple comparisons as there were no multiple outcome measures being compared in this analysis. The significance threshold (alpha) was set at 0.05.|Chi-squared||"The standard deviations (SD) for the groups are as follows:~For the group receiving 3g fosfomycin: 19.08 For the group receiving 500mg levofloxacin: 17.17"|This randomized controlled trial compared the incidence of UTI between two groups: patients receiving a single dose of 500 mg levofloxacin and patients receiving a single dose of 3 g fosfomycin one hour before a urodynamic study. The null hypothesis is that there is no significant difference in UTI incidence between the two groups. The power calculation was based on a sample size of 126 patients.|A chi-square test was performed to compare the incidence of UTIs between the two groups: patients receiving a single dose of 500 mg levofloxacin and those receiving a single dose of 3 g fosfomycin, both administered one hour before the urodynamic study (UDS). The result showed no statistically significant difference between the two groups (p = 0.660). An odds ratio was also calculated (OR = 0.8, 95% CI: 0.4-1.95), indicating a slightly lower likelihood of UTI in the fosfomycin group, but the difference was not significant.|1.95|0.4|0.660
74098038|NCT00936897|147744821|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.8|||ANCOVA||Denosumab - Ibandronate|||1.8|1.0|<0.0001
73880994|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0115|TWO_SIDED|95.0|1.38|12.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.50|1.38|0.0115
73880995|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.81||||0.2513|TWO_SIDED|95.0|0.66|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.98|0.66|0.2513
73880996|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0099|TWO_SIDED|95.0|1.39|11.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.14|1.39|0.0099
73888105|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|12.2||||0.2904|TWO_SIDED|95.0|-10.5|34.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.9|-10.5|0.2904
74048990|NCT00397631|147651444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.8|STANDARD_ERROR_OF_MEAN|3.87|<|0.001||95.0|-30.4|-15.2|||ANCOVA|Model terms: treatment, baseline FPG||||-15.2|-30.4|<0.001
74048991|NCT00397631|147651445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-44.7|STANDARD_ERROR_OF_MEAN|6.37|<|0.001||95.0|-57.2|32.2|||ANCOVA|Model terms: treatment, baseline 2-hour PPG||||32.2|-57.2|<0.001
74048992|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-1.17|||||TWO_SIDED|95.0|-25.61|23.27|||||Comparison for fasting, Day 7|An estimation approach was used.||23.27|-25.61|
74098039|NCT00936897|147744822|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74098040|NCT00936897|147744823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|||<|0.0001|TWO_SIDED|95.0|0.7|1.7|||ANCOVA||Denosumab - Ibandronate|||1.7|0.7|<0.0001
74098041|NCT00936897|147744824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.5|2.5|||ANCOVA||Denosumab - Ibandronate|||2.5|1.5|<0.0001
74098042|NCT04058067|147744825|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.2||0.013|TWO_SIDED|95.0|-3.7|1.1|||ANOVA|||||1.1|-3.7|0.013
74098043|NCT04058067|147744826|SUPERIORITY||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.15||0.035|TWO_SIDED|95.0|-4.2|0.4|||ANOVA|||||0.4|-4.2|0.035
74048993|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|13.22|||||TWO_SIDED|95.0|-9.84|36.27|||||Comparison for fasting, Day 7|An estimation approach was used.||36.27|-9.84|
74098044|NCT04058067|147744828|SUPERIORITY||Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-3.0|0.8|||ANOVA|||||0.8|-3.0|
74098045|NCT04058067|147744829|SUPERIORITY||Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-4.0|0.2|||ANOVA|||||0.2|-4.0|
74098046|NCT04058067|147744830|SUPERIORITY||Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-4.3|0.2|||ANOVA|||||0.2|-4.3|
74098047|NCT04058067|147744833|SUPERIORITY||DIfference|-3.0|||||TWO_SIDED|95.0|-13.7|6.7|||Regression, Logistic|||Proportion of subjects with ≥5 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||6.7|-13.7|
74098048|NCT04058067|147744833|SUPERIORITY||Difference|-2.6|||||TWO_SIDED|95.0|-14.7|9.4|||Regression, Logistic|||Proportion of subjects with ≥10 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||9.4|-14.7|
74098049|NCT04058067|147744833|SUPERIORITY||Difference|-3.8|||||TWO_SIDED|95.0|-15.5|6.9|||Regression, Logistic|||Proportion of subjects with ≥15 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||6.9|-15.5|
74098050|NCT04058067|147744837|SUPERIORITY||DIfference|0.1|||||TWO_SIDED|95.0|-4.2|4.4|||Regression, Logistic|||Proportion of subjects with ≥5 letters loss from baseline at Week 52||4.4|-4.2|
74098051|NCT04058067|147744837|SUPERIORITY||Difference|0.8|||||TWO_SIDED|95.0|-1.6|3.8|||Regression, Logistic|||Proportion of subjects with ≥10 letters loss from baseline at Week 52||3.8|-1.6|
74098052|NCT04058067|147744837|SUPERIORITY||Difference|0.0|||||TWO_SIDED|95.0|-2.2|2.3|||Regression, Logistic|||Proportion of subjects with ≥15 letters loss from baseline at Week 52||2.3|-2.2|
74098053|NCT04058067|147744838|OTHER|Descriptive, Week 4|Difference - %|0.4|||||TWO_SIDED|95.0|-7.9|8.6|||Clopper-Pearson exact method|||Week 4||8.6|-7.9|
74098054|NCT04058067|147744838|OTHER|Descriptive, Week 6|Difference - %|-5.1|||||TWO_SIDED|95.0|-14.3|2.9|||Clopper-Pearson exact method|||Week 6||2.9|-14.3|
74098055|NCT04058067|147744838|OTHER|Descriptive, Week 8|Difference - %|-4.0||||||95.0|-13.3|4.4|||Clopper-Pearson exact method|||Week 8||4.4|-13.3|
74098056|NCT04058067|147744838|OTHER|Descriptive, Week 12|Difference - %|-7.0|||||TWO_SIDED|95.0|-16.4|2.3|||Clopper-Pearson exact method|||Week 12||2.3|-16.4|
74098057|NCT04058067|147744838|OTHER|Descriptive, Week 16|Difference - %|-9.8|||||TWO_SIDED|95.0|-19.2|0.0|||Clopper-Pearson exact method|||Week 16||-0.0|-19.2|
74098058|NCT04058067|147744838|OTHER|Descriptive, Week 18|Difference - %|-9.8|||||TWO_SIDED|95.0|-19.0|0.0|||Clopper-Pearson exact method|||Week 18||-0.0|-19.0|
74098059|NCT04058067|147744838|OTHER|Descriptive, Week 20|Difference - %|-5.7|||||TWO_SIDED|95.0|-15.8|3.9|||Clopper-Pearson exact method|||Week 20||3.9|-15.8|
74098060|NCT04058067|147744838|OTHER|Descriptive, Week 24|Difference - %|-13.4|||||TWO_SIDED|95.0|-23.9|-3.1|||Clopper-Pearson exact method|||Week 24||-3.1|-23.9|
74098061|NCT04058067|147744838|OTHER|Descriptive, Week 28|Difference - %|-12.4|||||TWO_SIDED|95.0|-22.0|-2.1|||Clopper-Pearson exact method|||Week 28||-2.1|-22.0|
74098062|NCT04058067|147744838|OTHER|Descriptive, Week 32|Difference - %|-15.4|||||TWO_SIDED|95.0|-26.0|-4.8|||Clopper-Pearson exact method|||Week 32||-4.8|-26.0|
74098063|NCT04058067|147744838|OTHER|Descriptive, Week 36|Difference - %|-18.8|||||TWO_SIDED|95.0|-29.5|-8.9|||Clopper-Pearson exact method.|||Week 36||-8.9|-29.5|
74048994|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.77|||||TWO_SIDED|95.0|-41.43|-2.1|||||Comparison for fasting, Day 7|An estimation approach was used.||-2.10|-41.43|
74048995|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.1|||||TWO_SIDED|95.0|-42.63|-3.57|||||Comparison for fasting, Day 7|An estimation approach was used.||-3.57|-42.63|
74048996|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.79|||||TWO_SIDED|95.0|-30.85|7.28|||||Comparison for fasting, Day 7|An estimation approach was used.||7.28|-30.85|
74048997|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.04|||||TWO_SIDED|95.0|-27.66|7.57|||||Comparison for fasting, Day 7|An estimation approach was used.||7.57|-27.66|
74048998|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.14|||||TWO_SIDED|95.0|-37.72|7.43|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||7.43|-37.72|
74048999|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-2.1|||||TWO_SIDED|95.0|-23.66|19.45|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||19.45|-23.66|
73880997|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0242|TWO_SIDED|95.0|1.16|8.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.74|1.16|0.0242
74049000|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-20.66|||||TWO_SIDED|95.0|-38.75|-2.57|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-2.57|-38.75|
74049001|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.7|||||TWO_SIDED|95.0|-39.7|-3.71|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-3.71|-39.70|
74049002|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.62|||||TWO_SIDED|95.0|-28.62|7.38|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||7.38|-28.62|
74049003|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-26.03|||||TWO_SIDED|95.0|-41.94|-10.12|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-10.12|-41.94|
74049004|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-12.1|||||TWO_SIDED|95.0|-33.56|9.36|||||Comparison for fasting, Day 14|An estimation approach was used.||9.36|-33.56|
74049005|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.33|||||TWO_SIDED|95.0|-15.91|24.57|||||Comparison for fasting, Day 14|An estimation approach was used.||24.57|-15.91|
74049006|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-25.29|||||TWO_SIDED|95.0|-42.56|-8.02|||||Comparison for fasting, Day 14|An estimation approach was used.||-8.02|-42.56|
74049007|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.97|||||TWO_SIDED|95.0|-37.12|-2.82|||||Comparison for fasting, Day 14|An estimation approach was used.||-2.82|-37.12|
74049008|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.82|||||TWO_SIDED|95.0|-38.56|-5.08|||||Comparison for fasting, Day 14|An estimation approach was used.||-5.08|-38.56|
74049009|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-18.01|||||TWO_SIDED|95.0|-33.48|-2.55|||||Comparison for fasting, Day 14|An estimation approach was used.||-2.55|-33.48|
74049010|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.2|||||TWO_SIDED|95.0|-33.21|10.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||10.81|-33.21|
74049011|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.8|||||TWO_SIDED|95.0|-16.22|25.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||25.81|-16.22|
74049012|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.23|||||TWO_SIDED|95.0|-32.86|2.41|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||2.41|-32.86|
74049013|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-17.01|||||TWO_SIDED|95.0|-34.56|0.53|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||0.53|-34.56|
74049014|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.94|||||TWO_SIDED|95.0|-41.49|-6.39|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||-6.39|-41.49|
74098064|NCT04058067|147744838|OTHER|Descriptive, Week 40|Difference - %|-18.4|||||TWO_SIDED|95.0|-28.7|-8.6|||Clopper-Pearson exact method|||Week 40||-8.6|-28.7|
74098065|NCT04058067|147744838|OTHER|Descriptive, Week 44|Difference - %|-14.9|||||TWO_SIDED|95.0|-25.6|-4.4|||Clopper-Pearson exact method|||Week 44||-4.4|-25.6|
74098066|NCT04058067|147744838|OTHER|Descriptive, Week 48|Difference - %|-13.3|||||TWO_SIDED|95.0|-23.6|-3.4|||Clopper-Pearson exact method|||Week 48||-3.4|-23.6|
73880998|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1518|TWO_SIDED|95.0|0.77|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.60|0.77|0.1518
74098067|NCT04058067|147744838|OTHER|Descriptive, Week 52|Difference - %|-12.6|||||TWO_SIDED|95.0|-23.5|-2.9|||Clopper-Pearson exact method|||Week 52||-2.9|-23.5|
74098068|NCT04058067|147744839|SUPERIORITY||Difference|-1.3|||||TWO_SIDED|95.0|-13.6|11.2|||Clopper-Pearson exact method|||||11.2|-13.6|
73880999|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.95||||0.1811|TWO_SIDED|95.0|0.73|5.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.17|0.73|0.1811
73881000|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.88||||0.015|TWO_SIDED|95.0|1.3|11.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.55|1.30|0.0150
74049015|NCT02202161|147651446|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.45|||||TWO_SIDED|95.0|-34.96|-3.93|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||-3.93|-34.96|
74049016|NCT02202161|147651461|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.17|||||TWO_SIDED|90.0|0.92|1.49|||||Mean and confidence interval (CI) for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.49|0.92|
74049017|NCT02202161|147651461|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||TWO_SIDED|90.0|0.89|1.38|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.38|0.89|
74049018|NCT02202161|147651461|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.05|||||TWO_SIDED|90.0|0.87|1.27|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.27|0.87|
74049019|NCT02202161|147651461|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||TWO_SIDED|90.0|1.03|1.52|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.52|1.03|
74049020|NCT02202161|147651461|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||TWO_SIDED|90.0|1.04|1.5|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.50|1.04|
74098069|NCT04058067|147744841|SUPERIORITY||Difference|-10.2|STANDARD_ERROR_OF_MEAN|13.79|||TWO_SIDED|95.0|-37.3|17.0|||ANOVA|||||17.0|-37.3|
74098070|NCT04058067|147744842|SUPERIORITY||Difference|-2.5|STANDARD_ERROR_OF_MEAN|12.34|||TWO_SIDED|95.0|-26.8|21.9|||ANOVA|||||21.9|-26.8|
74049021|NCT02202161|147651461|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||TWO_SIDED|90.0|0.94|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.31|0.94|
74098071|NCT04058067|147744843|SUPERIORITY||Difference|-8.5|STANDARD_ERROR_OF_MEAN|11.03|||TWO_SIDED|95.0|-30.3|13.2|||ANOVA|||||13.2|-30.3|
74098072|NCT04058067|147744844|SUPERIORITY||Difference - %|5.3|||||TWO_SIDED|95.0|-3.3|13.5|||Clopper-Pearson exact method|||Week 4||13.5|-3.3|
74098073|NCT04058067|147744844|SUPERIORITY||Difference - %|10.8|||||TWO_SIDED|95.0|1.4|20.6|||Clopper-Pearson exact method|||Week 6||20.6|1.4|
74098074|NCT04058067|147744844|SUPERIORITY||Difference - %|14.1|||||TWO_SIDED|95.0|3.9|25.3|||Clopper-Pearson exact method|||Week 8||25.3|3.9|
74098075|NCT04058067|147744844|SUPERIORITY||Difference - %|14.1|||||TWO_SIDED|95.0|2.8|24.9|||Clopper-Pearson exact method||Proportion estimates (%) = 39.3|Week 12||24.9|2.8|
74098076|NCT04058067|147744844|SUPERIORITY||Difference - %|16.8||||||95.0|5.1|28.6|||Clopper-Pearson exact method|||Week 16||28.6|5.1|
74098077|NCT04058067|147744844|SUPERIORITY||Difference - %|15.4|||||TWO_SIDED|95.0|3.1|26.6|||Clopper-Pearson exact method|||Week 18||26.6|3.1|
74098078|NCT04058067|147744844|SUPERIORITY||Difference - %|15.7|||||TWO_SIDED|95.0|3.5|27.1|||Clopper-Pearson exact method|||Week 20||27.1|3.5|
74098079|NCT04058067|147744844|SUPERIORITY||Difference - %|19.1|||||TWO_SIDED|95.0|7.2|30.2|||Clopper-Pearson exact method|||Week 24||30.2|7.2|
74098080|NCT04058067|147744844|SUPERIORITY||Difference - %|16.4|||||TWO_SIDED|95.0|4.9|27.9|||Clopper-Pearson exact method|||Week 28||27.9|4.9|
74098081|NCT04058067|147744844|SUPERIORITY||Difference - %|12.1|||||TWO_SIDED|95.0|0.4|24.4|||Clopper-Pearson exact method|||Week 32||24.4|0.4|
74098082|NCT04058067|147744844|SUPERIORITY||Difference - %|6.0|||||TWO_SIDED|95.0|-5.9|18.0|||Clopper-Pearson exact method|||Week 36||18.0|-5.9|
74098083|NCT04058067|147744844|SUPERIORITY||Difference - %|15.2|||||TWO_SIDED|95.0|3.3|26.1|||Clopper-Pearson exact method|||Week 40||26.1|3.3|
74098084|NCT04058067|147744844|SUPERIORITY||Difference - %|13.2|||||TWO_SIDED|95.0|1.9|25.7|||Clopper-Pearson exact method|||Week 44||25.7|1.9|
74098085|NCT04058067|147744844|SUPERIORITY||Difference - %|11.9|||||TWO_SIDED|95.0|-0.8|23.6|||Clopper-Pearson exact method|||Week 48||23.6|-0.8|
74098086|NCT04058067|147744844|SUPERIORITY||Difference - %|17.9|||||TWO_SIDED|95.0|5.8|30.5|||Clopper-Pearson exact method|||Week 52||30.5|5.8|
74098087|NCT04058067|147744845|SUPERIORITY||Difference|0.9|||||TWO_SIDED|95.0|0.8|3.6|||Clopper-Pearson exact method|||||3.6|0.8|
74098088|NCT04058067|147744846|SUPERIORITY||Difference|-4.3|||||TWO_SIDED|95.0|-13.2|4.6|||Clopper-Pearson exact method|||||4.6|-13.2|
74098089|NCT04058067|147744847|SUPERIORITY||Difference|1.0|||||TWO_SIDED|95.0|-10.5|12.4|||Clopper-Pearson exact method|||||12.4|-10.5|
74098090|NCT04058067|147744852|OTHER|Descriptive, Week 28|Difference - %|-2.4|||||TWO_SIDED|95.0|-13.9|8.8|||Clopper-Pearson exact method|||Week 28||8.8|-13.9|
74098091|NCT04058067|147744852|OTHER|Descriptive, Week 52|Difference - %|-2.8|||||TWO_SIDED|95.0|-14.1|9.0|||Clopper-Pearson exact method|||Week 52||9.0|-14.1|
74098092|NCT04058067|147744854|OTHER|Descriptive, Week 28|Difference - %|4.2|||||TWO_SIDED|95.0|-4.1|12.6|||Clopper-Pearson exact method|||Week 28||12.6|-4.1|
74098093|NCT04058067|147744854|OTHER|Descriptive, Week 52|Difference - %|-0.5|||||TWO_SIDED|95.0|-10.5|9.3|||Clopper-Pearson exact method|||Week 52||9.3|-10.5|
74098094|NCT04058067|147744856|OTHER|Descriptive, Week 28|Difference - %|0.8|||||TWO_SIDED|95.0|0.7|2.9|||Clopper-Pearson exact method|||Week 28||2.9|0.7|
74098095|NCT04058067|147744858|OTHER|Descriptive, Week 28|Difference - %|0.8|||||TWO_SIDED|95.0|0.7|2.9|||Clopper-Pearson exact method|||Week 28||2.9|0.7|
74098096|NCT04058067|147744859|SUPERIORITY||LS mean difference|-0.9||||||95.0|-4.1|2.3|||ANCOVA|||Week 28||2.3|-4.1|
74098097|NCT04058067|147744859|SUPERIORITY||LS mean difference|0.1|||||TWO_SIDED|95.0|-3.1|3.3|||ANCOVA|||Week 52||3.3|-3.1|
74098098|NCT05005312|147744881|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|101.96|||||TWO_SIDED|90.0|74.2|140.11|||ANOVA|||||140.11|74.20|
74098099|NCT05005312|147744882|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|99.29|||||TWO_SIDED|90.0|70.81|139.21|||ANOVA|||||139.21|70.81|
74098100|NCT05005312|147744883|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|98.78|||||TWO_SIDED|90.0|70.65|138.12|||ANOVA|||||138.12|70.65|
74098101|NCT02704403|147744902|SUPERIORITY||Mean Difference (Net)|0.043||||0.0659|TWO_SIDED|95.0|-0.003|0.09|||Regression, Logistic|test is 2-sided, alpha=0.01||The null hypothesis was that there was no difference in response rates between the elafibranor and placebo treatment groups. The alternative hypothesis was that there was a difference in the response rates between the elafibranor and placebo treatment groups.||0.090|-0.003|0.0659
74098102|NCT02704403|147744903|SUPERIORITY||Cox Proportional Hazard|0.95|||||TWO_SIDED|95.0|0.619|1.457|||||No formal test due to the early termination of the study.|||1.457|0.619|
74098103|NCT02792699|147744911|OTHER||Geometric LS Mean|152371.4|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098104|NCT02792699|147744911|OTHER||LS Geometric Mean|159236.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098105|NCT02792699|147744911|OTHER||LS Geometric Mean|172213.2|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
73881001|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0046|TWO_SIDED|95.0|1.67|16.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.68|1.67|0.0046
74049022|NCT02202161|147651463|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|0.88|||||TWO_SIDED|90.0|0.68|1.13|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.13|0.68|
74049023|NCT02202161|147651463|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||TWO_SIDED|90.0|0.82|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.31|0.82|
74049024|NCT02202161|147651463|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||TWO_SIDED|90.0|0.85|1.26|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.26|0.85|
74049025|NCT02202161|147651463|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.19|||||TWO_SIDED|90.0|0.97|1.45|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.45|0.97|
74049026|NCT02202161|147651463|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.23|||||TWO_SIDED|90.0|1.01|1.49|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.49|1.01|
74049027|NCT02202161|147651463|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.24|||||TWO_SIDED|90.0|1.04|1.48|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.48|1.04|
74049028|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.91|1.17|||||Comparison for Day 7, cholesterol|An estimation approach was used.||1.17|0.91|
74049029|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.88|||||TWO_SIDED|95.0|0.78|0.98|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.98|0.78|
74049030|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.86|||||TWO_SIDED|95.0|0.78|0.95|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.95|0.78|
74049031|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|0.68|0.83|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.83|0.68|
73888106|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|26.0||||0.0467|TWO_SIDED|95.0|0.4|51.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.6|0.4|0.0467
74049032|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||TWO_SIDED|95.0|0.76|0.92|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.92|0.76|
74049033|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||TWO_SIDED|95.0|0.92|1.1|||||Comparison for Day 7, cholesterol|An estimation approach was used.||1.10|0.92|
74049034|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||TWO_SIDED|95.0|0.95|1.19|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.19|0.95|
74049035|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.04|||||TWO_SIDED|95.0|0.94|1.16|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.16|0.94|
74049036|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.88|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.05|0.88|
74049037|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.89|1.07|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.07|0.89|
74049038|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||TWO_SIDED|95.0|0.98|1.17|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.17|0.98|
74049039|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.9|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.05|0.90|
74049040|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||TWO_SIDED|95.0|0.8|1.13|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||1.13|0.80|
74049041|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.76|||||TWO_SIDED|95.0|0.65|0.9|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.90|0.65|
74049042|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.64|0.85|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.85|0.64|
74049043|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.59|||||TWO_SIDED|95.0|0.51|0.69|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.69|0.51|
74049044|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.81|0.62|
74049045|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.89|1.14|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||1.14|0.89|
74049046|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.88|1.21|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||1.21|0.88|
74049047|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.71|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.95|0.71|
74049048|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.84|||||TWO_SIDED|95.0|0.74|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.95|0.74|
74049049|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|0.59|0.76|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.76|0.59|
74049050|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.87|0.68|
74049051|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||TWO_SIDED|95.0|0.92|1.14|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||1.14|0.92|
74049052|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.27|||||TWO_SIDED|95.0|0.97|1.66|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.66|0.97|
74049053|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.16|||||TWO_SIDED|95.0|0.9|1.5|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.50|0.90|
74049054|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|1.06|1.61|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.61|1.06|
74049055|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.19|||||TWO_SIDED|95.0|0.96|1.48|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.48|0.96|
74049056|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.15|||||TWO_SIDED|95.0|0.93|1.42|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.42|0.93|
74049057|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||TWO_SIDED|95.0|0.79|1.16|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.16|0.79|
74049058|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.86|1.17|||||Comparison for Day 14, cholesterol|An estimation approach was used.||1.17|0.86|
74049059|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||TWO_SIDED|95.0|0.73|0.96|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.96|0.73|
74049060|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.73|0.91|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.91|0.73|
74049061|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.66|0.82|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.82|0.66|
74049062|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.69|0.86|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.86|0.69|
74049063|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||Comparison for Day 14, cholesterol|An estimation approach was used.||1.03|0.84|
74049064|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.09|||||TWO_SIDED|95.0|0.99|1.21|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.21|0.99|
74049065|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.11|0.93|
74049066|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.9|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.04|0.90|
74049067|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.06|0.92|
74049068|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||TWO_SIDED|95.0|0.94|1.08|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.08|0.94|
74049069|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.92|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.04|0.92|
74049070|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.85|||||TWO_SIDED|95.0|0.69|1.04|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||1.04|0.69|
74049071|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.58|0.85|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.85|0.58|
74049072|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||TWO_SIDED|95.0|0.62|0.86|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.86|0.62|
74049073|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|0.5|0.71|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.71|0.50|
74049074|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|0.59|0.8|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.80|0.59|
74049075|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.94|||||TWO_SIDED|95.0|0.81|1.09|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||1.09|0.81|
74049076|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.8|1.22|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||1.22|0.80|
74049077|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.64|0.93|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.93|0.64|
74049078|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.67|0.9|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.90|0.67|
74098106|NCT02792699|147744911|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9569|||||TWO_SIDED|90.0|0.887|1.0323||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0323|0.8870|
74098107|NCT02792699|147744911|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8848|||||TWO_SIDED|90.0|0.8204|0.9542||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9542|0.8204|
74098108|NCT02792699|147744911|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9246|||||TWO_SIDED|90.0|0.8575|0.997||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9970|0.8575|
74098109|NCT02792699|147744912|OTHER||Geometric LS Mean|368.43|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098110|NCT02792699|147744912|OTHER||LS Geometric Mean|374.44|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098111|NCT02792699|147744912|OTHER||LS Geometric Mean|393.29|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098112|NCT02792699|147744912|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.984|||||TWO_SIDED|90.0|0.9356|1.0348||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0348|0.9356|
74098113|NCT02792699|147744912|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9368|||||TWO_SIDED|90.0|0.8912|0.9848||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9848|0.8912|
74098114|NCT02792699|147744912|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9521|||||TWO_SIDED|90.0|0.9055|1.001||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0010|0.9055|
74098115|NCT02792699|147744913|OTHER||Geometric LS Mean|42203.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098116|NCT02792699|147744913|OTHER||LS Geometric Mean|43378.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098117|NCT02792699|147744913|OTHER||LS Geometric Mean|44925.3|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098118|NCT02792699|147744913|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9729|||||TWO_SIDED|90.0|0.9174|1.0318||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0318|0.9174|
74098119|NCT02792699|147744913|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9394|||||TWO_SIDED|90.0|0.8863|0.9958||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9958|0.8863|
74098120|NCT02792699|147744913|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9656|||||TWO_SIDED|90.0|0.9104|1.024||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0240|0.9104|
74098121|NCT02792699|147744914|OTHER||Geometric LS Mean|149590.5|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098122|NCT02792699|147744914|OTHER||LS Geometric Mean|155778.7|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098123|NCT02792699|147744914|OTHER||LS Geometric Mean|166811.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098124|NCT02792699|147744914|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9603|||||TWO_SIDED|90.0|0.895|1.0303||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0303|0.8950|
74098125|NCT02792699|147744914|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8968|||||TWO_SIDED|90.0|0.8363|0.9616||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9616|0.8363|
74098126|NCT02792699|147744914|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9339|||||TWO_SIDED|90.0|0.8707|1.0016||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0016|0.8707|
74098127|NCT02792699|147744915|OTHER||Geometric LS Mean|304.04|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098128|NCT02792699|147744915|OTHER||LS Geometric Mean|305.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098129|NCT02792699|147744915|OTHER||LS Geometric Mean|320.87|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
74098130|NCT02792699|147744915|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9942|||||TWO_SIDED|90.0|0.9461|1.0448||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0448|0.9461|
74098131|NCT02792699|147744915|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9475|||||TWO_SIDED|90.0|0.9021|0.9953||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9953|0.9021|
74098132|NCT02792699|147744915|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9531|||||TWO_SIDED|90.0|0.907|1.0015||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0015|0.9070|
74098133|NCT02792699|147744924|EQUIVALENCE|Clinical equivalence was tested by comparing the 2-sided 90% CI of the change from baseline at week 24 of DAS28-CRP between ABP 798 and rituximab with an equivalence margin of (-0.6, 0.6).|LS Mean Difference|0.02|||||TWO_SIDED|90.0|-0.225|0.264||||||If PK similarity was established between rituximab (US) and rituximab (EU), the 2 rituximab arms were to be combined into a single reference group for the primary assessment of clinical equivalence of DAS28-CRP change from baseline at week 24 using a repeated measures analysis with DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and baseline DAS28-CRP as predictors, and unstructured covariance matrix in the model.||0.264|-0.225|
73881002|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3788|TWO_SIDED|95.0|0.57|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.34|0.57|0.3788
74098134|NCT02792699|147744924|OTHER||LS Mean Difference|-0.07|||||TWO_SIDED|90.0|-0.353|0.213||||||||0.213|-0.353|
74098135|NCT02792699|147744924|OTHER||LS Mean Difference|0.11|||||TWO_SIDED|90.0|-0.171|0.392||||||||0.392|-0.171|
74098136|NCT02792699|147744925|OTHER||LS Mean Difference|0.064|||||TWO_SIDED|90.0|-0.203|0.33||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.330|-0.203|
74098137|NCT02792699|147744925|OTHER||LS Mean Difference|-0.147|||||TWO_SIDED|90.0|-0.411|0.117||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.117|-0.411|
74098138|NCT02792699|147744925|OTHER||LS Mean Difference|0.502|||||TWO_SIDED|90.0|0.233|0.772||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.772|0.233|
74098139|NCT02792699|147744925|OTHER||LS Mean Difference|0.27|||||TWO_SIDED|90.0|0.0|0.539||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.539|0.000|
74098140|NCT02792699|147744925|OTHER||LS Mean Difference|0.255|||||TWO_SIDED|90.0|-0.04|0.55||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.550|-0.040|
73881003|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0424|TWO_SIDED|95.0|1.04|7.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.70|1.04|0.0424
73881004|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0139|TWO_SIDED|95.0|1.3|10.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.43|1.30|0.0139
73881005|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3057|TWO_SIDED|95.0|0.63|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.42|0.63|0.3057
73881006|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3717|TWO_SIDED|95.0|0.59|4.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.02|0.59|0.3717
73881007|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0252|TWO_SIDED|95.0|1.16|9.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.50|1.16|0.0252
73881008|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.56||||0.0235|TWO_SIDED|95.0|1.19|10.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.69|1.19|0.0235
74098141|NCT02792699|147744925|OTHER||LS Mean Difference|0.16|||||TWO_SIDED|90.0|-0.135|0.455||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.455|-0.135|
74098142|NCT02792699|147744925|OTHER||LS Mean Difference|0.262|||||TWO_SIDED|90.0|-0.04|0.564||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.564|-0.040|
73881009|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.25||||0.658|TWO_SIDED|95.0|0.46|3.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.39|0.46|0.6580
73881010|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0061|TWO_SIDED|95.0|1.54|13.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.62|1.54|0.0061
73881011|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0149|TWO_SIDED|95.0|1.29|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.61|1.29|0.0149
73881012|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.95||||0.9282|TWO_SIDED|95.0|0.35|2.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.62|0.35|0.9282
73881013|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7902|TWO_SIDED|95.0|0.33|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.35|0.33|0.7902
73881014|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1603|TWO_SIDED|95.0|0.73|6.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.74|0.73|0.1603
73881015|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1144|TWO_SIDED|95.0|0.8|8.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.14|0.80|0.1144
73881016|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.75||||0.5903|TWO_SIDED|95.0|0.26|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.13|0.26|0.5903
73881017|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.89||||0.029|TWO_SIDED|95.0|1.15|13.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.16|1.15|0.0290
73888107|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|10.7||||0.4056|TWO_SIDED|95.0|-14.6|36.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.0|-14.6|0.4056
73881018|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1721|TWO_SIDED|95.0|0.72|6.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.26|0.72|0.1721
73881019|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2439|TWO_SIDED|95.0|0.66|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.09|0.66|0.2439
73881020|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7402|TWO_SIDED|95.0|0.44|3.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.19|0.44|0.7402
73881021|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0422|TWO_SIDED|95.0|1.04|9.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.63|1.04|0.0422
73881022|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0061|TWO_SIDED|95.0|1.62|18.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.27|1.62|0.0061
73881023|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3191|TWO_SIDED|95.0|0.59|4.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.92|0.59|0.3191
74049079|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.65|||||TWO_SIDED|95.0|0.55|0.75|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.75|0.55|
74049080|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.6|0.81|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.81|0.60|
73881024|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|5.91||||0.0037|TWO_SIDED|95.0|1.78|19.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||19.66|1.78|0.0037
73881025|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0139|TWO_SIDED|95.0|1.33|12.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.20|1.33|0.0139
73881026|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.59||||0.3757|TWO_SIDED|95.0|0.57|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.42|0.57|0.3757
73881027|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7087|TWO_SIDED|95.0|0.45|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.28|0.45|0.7087
73881028|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.53||||0.1083|TWO_SIDED|95.0|0.81|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.88|0.81|0.1083
73881029|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0473|TWO_SIDED|95.0|1.01|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.14|1.01|0.0473
73881030|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2481|TWO_SIDED|95.0|0.64|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.60|0.64|0.2481
73881031|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|5.84||||0.0066|TWO_SIDED|95.0|1.64|20.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||20.89|1.64|0.0066
73881032|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0466|TWO_SIDED|95.0|1.02|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.18|1.02|0.0466
74049081|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||TWO_SIDED|95.0|0.8|1.04|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||1.04|0.80|
74049082|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.42|||||TWO_SIDED|95.0|1.01|2.0|||||Comparison for Day 14, triglycerides|An estimation approach was used.||2.00|1.01|
73881033|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8769|TWO_SIDED|95.0|0.34|2.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.53|0.34|0.8769
74049083|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.28|||||TWO_SIDED|95.0|0.94|1.75|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.75|0.94|
74049084|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.24|||||TWO_SIDED|95.0|0.98|1.58|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.58|0.98|
74049085|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.22|||||TWO_SIDED|95.0|0.95|1.56|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.56|0.95|
74049086|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.23|||||TWO_SIDED|95.0|0.96|1.57|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.57|0.96|
74049087|NCT02202161|147651464|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.89|||||TWO_SIDED|95.0|0.72|1.11|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.11|0.72|
74049088|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.87|1.11|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||1.11|0.87|
74049089|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.79|||||TWO_SIDED|95.0|0.71|0.89|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.89|0.71|
74049090|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.74|0.9|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.90|0.74|
74049091|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.63|0.77|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.77|0.63|
74049092|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.7|0.85|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.85|0.70|
74049093|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.89|1.06|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||1.06|0.89|
74049094|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||TWO_SIDED|95.0|0.77|1.07|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||1.07|0.77|
74049095|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.81|||||TWO_SIDED|95.0|0.68|0.95|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.95|0.68|
74049096|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|0.7|0.91|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.91|0.70|
74049097|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|0.58|0.77|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.77|0.58|
74049098|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.83|0.64|
74049099|NCT02202161|147651465|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|0.8|1.02|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||1.02|0.80|
74049100|NCT01930487|147651486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.037|STANDARD_ERROR_OF_MEAN|0.011||0.0016|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0016
74049101|NCT01930487|147651487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.011||0.0249|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0249
74049102|NCT01930487|147651488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.3||0.9147|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.9147
74049103|NCT01930487|147651489|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|0.59||0.007|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0070
74049104|NCT01930487|147651490|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.97|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED||||||paired t-test, 2-sidede||dietary supplement with antioxidants - placebo|||||<0.0001
74049105|NCT01930487|147651491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.23||0.0476|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0476
73881034|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.37||||0.5448|TWO_SIDED|95.0|0.49|3.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.82|0.49|0.5448
73881035|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.57||||0.4125|TWO_SIDED|95.0|0.53|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.64|0.53|0.4125
73881036|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.36||||0.05|TWO_SIDED|95.0|1.0|11.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.30|1.00|0.0500
73881037|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6167|TWO_SIDED|95.0|0.45|3.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.87|0.45|0.6167
73881038|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0233|TWO_SIDED|95.0|1.21|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||13.26|1.21|0.0233
73881039|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0803|TWO_SIDED|95.0|0.89|8.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.09|0.89|0.0803
73881040|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.64||||0.1274|TWO_SIDED|95.0|0.76|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.18|0.76|0.1274
73881041|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.05||||0.9445|TWO_SIDED|95.0|0.29|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.71|0.29|0.9445
73881042|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.69||||0.4204|TWO_SIDED|95.0|0.47|6.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.03|0.47|0.4204
74049106|NCT01930487|147651492|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.21||0.0352|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0352
73881043|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.78||||0.1315|TWO_SIDED|95.0|0.74|10.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.49|0.74|0.1315
73881044|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0944|TWO_SIDED|95.0|0.82|12.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.87|0.82|0.0944
73881045|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.99||||0.2801|TWO_SIDED|95.0|0.57|6.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.89|0.57|0.2801
73881046|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1524|TWO_SIDED|95.0|0.72|8.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.30|0.72|0.1524
73881047|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.38||||0.6129|TWO_SIDED|95.0|0.4|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.75|0.40|0.6129
74049107|NCT01930487|147651493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.21||0.0208|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0208
74049108|NCT01930487|147651494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||<0.0001
74049109|NCT01930487|147651495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.07||0.0024|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0024
73881048|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.63||||0.4617|TWO_SIDED|95.0|0.18|2.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.18|0.18|0.4617
73881049|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.74||||0.6519|TWO_SIDED|95.0|0.2|2.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.70|0.20|0.6519
73881050|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8011|TWO_SIDED|95.0|0.22|3.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.18|0.22|0.8011
73881051|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3254|TWO_SIDED|95.0|0.51|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.41|0.51|0.3254
73881052|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|2.0||||0.273|TWO_SIDED|95.0|0.58|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.94|0.58|0.2730
73881053|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6601|TWO_SIDED|95.0|0.39|4.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.41|0.39|0.6601
73881054|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.74||||0.6588|TWO_SIDED|95.0|0.2|2.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.76|0.20|0.6588
73881055|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.52||||0.3257|TWO_SIDED|95.0|0.14|1.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.92|0.14|0.3257
73881056|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.42||||0.2229|TWO_SIDED|95.0|0.1|1.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.69|0.10|0.2229
73881057|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.43||||0.2425|TWO_SIDED|95.0|0.1|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.77|0.10|0.2425
73881058|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9672|TWO_SIDED|95.0|0.23|4.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.11|0.23|0.9672
74049110|NCT01930487|147651496|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.07||0.0081|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0081
74049111|NCT01930487|147651497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.008||0.8191|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.8191
73881059|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|1.43||||0.5838|TWO_SIDED|95.0|0.4|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.09|0.40|0.5838
73881060|NCT03192176|147297628|SUPERIORITY||Odds Ratio (OR)|0.95||||0.9361|TWO_SIDED|95.0|0.28|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.24|0.28|0.9361
73881061|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0429|TWO_SIDED|95.0|1.03|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.55|1.03|0.0429
73881062|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0296|TWO_SIDED|95.0|1.11|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||7.12|1.11|0.0296
74049112|NCT01930487|147651498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.009||0.0482|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0482
74049113|NCT01930487|147651499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.019|STANDARD_ERROR_OF_MEAN|0.023||0.023|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0230
74049114|NCT01930487|147651500|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.008||0.1202|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.1202
74049115|NCT01930487|147651501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.55|STANDARD_ERROR_OF_MEAN|0.83||0.0063|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0063
74049116|NCT01930487|147651502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.8||0.3347|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3347
74049117|NCT01930487|147651503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.35||0.0094|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0094
74049118|NCT01930487|147651504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92|STANDARD_ERROR_OF_MEAN|0.24||0.0009|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0009
74049119|NCT01930487|147651505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.34||0.0067|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0067
74049120|NCT01930487|147651506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.6938|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.6938
74049121|NCT01930487|147651507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.3||0.0805|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0805
74049122|NCT01930487|147651508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.29||0.2451|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.2451
74049123|NCT01930487|147651509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78|STANDARD_ERROR_OF_MEAN|0.34||0.0323|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0323
74049124|NCT01930487|147651510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.26||0.344|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3440
74049125|NCT01930487|147651511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.13||0.0119|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0119
74098143|NCT02792699|147744925|OTHER||LS Mean Difference|0.08|||||TWO_SIDED|90.0|-0.216|0.376||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.376|-0.216|
74049126|NCT01930487|147651512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||<0.0001
74049127|NCT01930487|147651513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.12||0.0137|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0137
74049128|NCT01930487|147651514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.09||0.0866|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0866
74049129|NCT01930487|147651515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0656|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0656
74049130|NCT01930487|147651516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.09||0.0626|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0626
74049131|NCT01930487|147651517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.013||0.81|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.8100
74098144|NCT02792699|147744926|OTHER||Risk Ratio (RR)|0.9339|||||TWO_SIDED|90.0|0.7696|1.1332||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1332|0.7696|
74049132|NCT01930487|147651518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.01||0.9556|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.9556
74049133|NCT01930487|147651519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.015||0.3414|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3414
74049134|NCT01930487|147651520|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021|STANDARD_ERROR_OF_MEAN|0.009||0.033|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0330
74049135|NCT01930487|147651521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3326|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3326
74049136|NCT01930487|147651522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.012||0.0348|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0348
74049137|NCT01930487|147651523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.016|STANDARD_ERROR_OF_MEAN|0.012||0.2089|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.2089
74049138|NCT01930487|147651524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.012||0.3738|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3738
74049139|NCT01930487|147651525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.447|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.4470
74049140|NCT01930487|147651526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|2.1||0.6382|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.6382
74049141|NCT01930487|147651527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.012||0.0026|TWO_SIDED||||||paird t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0026
74049142|NCT01930487|147651528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.018||0.1045|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.1045
74049143|NCT01930487|147651529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.013||0.6941|TWO_SIDED||||||paired t-test||dietary supplement with antioxidants - placebo|||||0.6941
74049144|NCT01930487|147651530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.046|STANDARD_ERROR_OF_MEAN|0.017||0.0138|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0138
74049145|NCT02711553|147651531|SUPERIORITY||Hazard Ratio (HR)|1.123||||0.4821|TWO_SIDED|80.0|0.904|1.395||p-value is 2-sided.|Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.395|0.904|0.4821
74098145|NCT02792699|147744926|OTHER||Risk Difference (RD)|-0.036|||||TWO_SIDED|90.0|-0.1495|0.0775||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0775|-0.1495|
74098146|NCT02792699|147744926|OTHER||Risk Ratio (RR)|1.0392|||||TWO_SIDED|90.0|0.8436|1.2801||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2801|0.8436|
74098147|NCT02792699|147744926|OTHER||Risk Difference (RD)|0.0246|||||TWO_SIDED|90.0|-0.091|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1402|-0.0910|
74098148|NCT02792699|147744926|OTHER||Risk Ratio (RR)|0.878|||||TWO_SIDED|90.0|0.7573|1.0179||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0179|0.7573|
74098149|NCT02792699|147744926|OTHER||Risk Difference (RD)|-0.0794|||||TWO_SIDED|90.0|-0.1834|0.0247||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0247|-0.1834|
74098150|NCT02792699|147744926|OTHER||Risk Ratio (RR)|1.0426|||||TWO_SIDED|90.0|0.877|1.2394||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2394|0.8770|
74098151|NCT02792699|147744926|OTHER||Risk Difference (RD)|0.0348|||||TWO_SIDED|90.0|-0.0758|0.1454||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1454|-0.0758|
74098152|NCT02792699|147744926|OTHER||Risk Ratio (RR)|1.0102|||||TWO_SIDED|90.0|0.8743|1.1671||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1671|0.8743|
74098153|NCT02792699|147744926|OTHER||Risk Difference (RD)|0.0199|||||TWO_SIDED|90.0|-0.0835|0.1234||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1234|-0.0835|
74098154|NCT02792699|147744926|OTHER||Risk Ratio (RR)|1.0793|||||TWO_SIDED|90.0|0.9244|1.2601||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2601|0.9244|
74098155|NCT02792699|147744926|OTHER||Risk Difference (RD)|0.0561|||||TWO_SIDED|90.0|-0.0493|0.1615||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1615|-0.0493|
74098156|NCT02792699|147744926|OTHER||Risk Ratio (RR)|0.8848|||||TWO_SIDED|90.0|0.7759|1.0091||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0091|0.7759|
74098157|NCT02792699|147744926|OTHER||Risk Difference (RD)|-0.0776|||||TWO_SIDED|90.0|-0.1789|0.0237||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0237|-0.1789|
74098158|NCT02792699|147744926|OTHER||Risk Ratio (RR)|0.9982|||||TWO_SIDED|90.0|0.8585|1.1605||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1605|0.8585|
74098159|NCT02792699|147744926|OTHER||Risk Difference (RD)|0.0008|||||TWO_SIDED|90.0|-0.1038|0.1054||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1054|-0.1038|
74098160|NCT02792699|147744926|OTHER||Risk Ratio (RR)|0.7862|||||TWO_SIDED|90.0|0.6722|0.9196||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.9196|0.6722|
73881063|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0032|TWO_SIDED|95.0|1.65|12.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.13|1.65|0.0032
74098161|NCT02792699|147744926|OTHER||Risk Difference (RD)|-0.2004|||||TWO_SIDED|90.0|-0.3066|-0.0941||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||-0.0941|-0.3066|
74098162|NCT02792699|147744926|OTHER||Risk Ratio (RR)|0.8804|||||TWO_SIDED|90.0|0.7587|1.0215||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0215|0.7587|
74098163|NCT02792699|147744926|OTHER||Risk Difference (RD)|-0.1037|||||TWO_SIDED|90.0|-0.2066|-0.0007||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||-0.0007|-0.2066|
74098164|NCT02792699|147744927|OTHER||Risk Ratio (RR)|0.9256|||||TWO_SIDED|90.0|0.64|1.3388||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3388|0.6400|
74098165|NCT02792699|147744927|OTHER||Risk Difference (RD)|-0.0181|||||TWO_SIDED|90.0|-0.1209|0.0847||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0847|-0.1209|
74098166|NCT02792699|147744927|OTHER||Risk Ratio (RR)|1.0868|||||TWO_SIDED|90.0|0.7328|1.6119||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.6119|0.7328|
74098167|NCT02792699|147744927|OTHER||Risk Difference (RD)|0.0201|||||TWO_SIDED|90.0|-0.0803|0.1205||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1205|-0.0803|
74098168|NCT02792699|147744927|OTHER||Risk Ratio (RR)|0.7095|||||TWO_SIDED|90.0|0.5387|0.9346||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.9346|0.5387|
74098169|NCT02792699|147744927|OTHER||Risk Difference (RD)|-0.1109|||||TWO_SIDED|90.0|-0.2231|0.0013||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0013|-0.2231|
74098170|NCT02792699|147744927|OTHER||Risk Ratio (RR)|1.0882|||||TWO_SIDED|90.0|0.7829|1.5127||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.5127|0.7829|
74098171|NCT02792699|147744927|OTHER||Risk Difference (RD)|0.0441|||||TWO_SIDED|90.0|-0.0626|0.1508||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1508|-0.0626|
74098172|NCT02792699|147744927|OTHER||Risk Ratio (RR)|0.9612|||||TWO_SIDED|90.0|0.7273|1.2705||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2705|0.7273|
74049146|NCT02711553|147651531|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6417|TWO_SIDED|80.0|0.734|1.153||p-value is 2-sided.|Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.153|0.734|0.6417
74049147|NCT02711553|147651532|SUPERIORITY||Hazard Ratio (HR)|1.336||||0.087|TWO_SIDED|95.0|0.959|1.862|||Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.862|0.959|0.0870
74049148|NCT02711553|147651532|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.7599|TWO_SIDED|95.0|0.669|1.342|||Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.342|0.669|0.7599
74049149|NCT02711553|147651533|SUPERIORITY||Odds Ratio (OR)|1.0||||0.878|TWO_SIDED|95.0|0.6|1.9|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||1.9|0.6|0.878
74049150|NCT02711553|147651533|SUPERIORITY||Odds Ratio (OR)|0.5||||0.023|TWO_SIDED|95.0|0.2|0.9|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||0.9|0.2|0.023
74049151|NCT02711553|147651534|SUPERIORITY||Odds Ratio (OR)|1.2||||0.68|TWO_SIDED|95.0|0.6|2.4|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||2.4|0.6|0.680
74049152|NCT02711553|147651534|SUPERIORITY||Odds Ratio (OR)|1.3||||0.499|TWO_SIDED|95.0|0.6|2.6|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||2.6|0.6|0.499
74049153|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.069|TWO_SIDED|95.0|-2.28|0.09||p-values are from Type 3 sums of squares mixed model repeated measures (MMRM) Model.|MMRM Model|Least Squares (LS) Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||PWB||0.09|-2.28|0.069
74049154|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.6||0.042|TWO_SIDED|95.0|-2.42|-0.04||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||PWB||-0.04|-2.42|0.042
74049155|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.51||0.112|TWO_SIDED|95.0|-1.83|0.19||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||SWB||0.19|-1.83|0.112
74098173|NCT02792699|147744927|OTHER||Risk Difference (RD)|0.002|||||TWO_SIDED|90.0|-0.1081|0.1122||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1122|-0.1081|
74049156|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.51||0.505|TWO_SIDED|95.0|-1.35|0.67||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||SWB||0.67|-1.35|0.505
74049157|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.44||0.116|TWO_SIDED|95.0|-1.56|0.17||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||EWB||0.17|-1.56|0.116
74049158|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.45||0.521|TWO_SIDED|95.0|-1.16|0.59||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||EWB||0.59|-1.16|0.521
74098174|NCT02792699|147744927|OTHER||Risk Ratio (RR)|1.0029|||||TWO_SIDED|90.0|0.756|1.3305||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3305|0.7560|
73881064|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0006|TWO_SIDED|95.0|2.31|21.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||21.90|2.31|0.0006
74098175|NCT02792699|147744927|OTHER||Risk Difference (RD)|0.0039|||||TWO_SIDED|90.0|-0.1056|0.1135||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1135|-0.1056|
74049159|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.62||0.008|TWO_SIDED|95.0|-2.87|-0.44||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FWB||-0.44|-2.87|0.008
74049160|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.62||0.335|TWO_SIDED|95.0|-1.82|0.62||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FWB||0.62|-1.82|0.335
74049161|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|0.89||0.001|TWO_SIDED|95.0|-4.69|-1.18||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||HCS||-1.18|-4.69|0.001
74049162|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.89||0.068|TWO_SIDED|95.0|-3.4|0.12||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||HCS||0.12|-3.40|0.068
74049163|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.52||0.051|TWO_SIDED|95.0|-2.04|0.0||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FACT-Hep||0.00|-2.04|0.051
74049164|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.52||0.212|TWO_SIDED|95.0|-1.68|0.38||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FACT-Hep||0.38|-1.68|0.212
74049165|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|-9.3|-2.04||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||TOI||-2.04|-9.30|0.002
74049166|NCT02711553|147651538|SUPERIORITY||LS Mean Difference|-3.42|STANDARD_ERROR_OF_MEAN|1.85||0.066|TWO_SIDED|95.0|-7.07|0.22||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||TOI||0.22|-7.07|0.066
74049167|NCT05559203|147651545|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.752|||||||t-test, 2 sided|paired sample||Feasibility study so no power calculation. N = 18 with baseline and follow-up data.||||.752
74049168|NCT05559203|147651546|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.197|||||||t-test, 2 sided|||Feasibility study so no power calculation. N = 18 with baseline and follow-up data.||||.197
74049169|NCT05559203|147651547|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.562|||||||t-test, 2 sided|||||||.562
74049170|NCT05559203|147651548|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.02|||||||t-test, 2 sided|||Anxiety subscale||||.020
74049171|NCT05559203|147651548|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.002|||||||t-test, 2 sided|||Depression subscale||||.002
74049172|NCT05559203|147651549|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.036|||||||t-test, 2 sided|||||||.036
74049173|NCT05559203|147651550|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.042|||||||t-test, 2 sided|||||||.042
74049174|NCT05559203|147651551|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention|||||<|0.001|||||||t-test, 2 sided|||||||<.001
74049175|NCT05559203|147651552|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.781|||||||t-test, 2 sided|||||||.781
74049176|NCT01012037|147651646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.97|-0.52|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo||-0.52|-0.97|<0.0001
74049177|NCT01012037|147651646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.02|-0.58|||ANCOVA|||Linagliptin 5mg qd versus Placebo||-0.58|-1.02|<0.0001
74049178|NCT01012037|147651646|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.07|0.19|||ANCOVA|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.19|-0.07|
74049179|NCT01012037|147651647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.83|-0.48|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-0.48|-0.83|<0.0001
74049180|NCT01012037|147651647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.84|-0.49|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-0.49|-0.84|<0.0001
74049181|NCT01012037|147651647|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.05||||95.0|-0.1|0.1|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.10|-0.10|
74049182|NCT01012037|147651648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.0|-0.54|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-0.54|-1.00|<0.0001
74049183|NCT01012037|147651648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.05|-0.59|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-0.59|-1.05|<0.0001
74049184|NCT01012037|147651648|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.08|0.18|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.18|-0.08|
74049185|NCT01012037|147651649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|4.6||0.0029||95.0|-22.7|-4.7|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo||-4.7|-22.7|0.0029
74049186|NCT01012037|147651649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|4.6||0.0001||95.0|-26.7|-8.8|||ANCOVA|||Linagliptin 5 mg qd versus Placebo||-8.8|-26.7|0.0001
74049187|NCT01012037|147651649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-1.0|9.2|||ANCOVA||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||9.2|-1.0|
74049188|NCT01012037|147651650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.6|STANDARD_ERROR_OF_MEAN|4.4||0.0002||95.0|-25.3|-7.8|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-7.8|-25.3|0.0002
74049189|NCT01012037|147651650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.9|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001||95.0|-27.6|-10.2|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-10.2|-27.6|<0.0001
74049190|NCT01012037|147651650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|2.5||||95.0|-2.6|7.3|||Mixed Models Analysis||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||7.3|-2.6|
74049191|NCT01012037|147651651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|5.4||0.0653||95.0|-20.6|0.6|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||0.6|-20.6|0.0653
74049192|NCT01012037|147651651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|5.4||0.0047||95.0|-25.8|-4.7|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-4.7|-25.8|0.0047
74049193|NCT01012037|147651651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|3.0||||95.0|-0.7|11.3|||Mixed Models Analysis||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||11.3|-0.7|
74049194|NCT02237898|147651667|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
73881065|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.8||||0.2073|TWO_SIDED|95.0|0.72|4.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||4.47|0.72|0.2073
73881066|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0096|TWO_SIDED|95.0|1.36|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||9.20|1.36|0.0096
73881067|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.52||||0.0462|TWO_SIDED|95.0|1.02|6.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.27|1.02|0.0462
73881068|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1387|TWO_SIDED|95.0|0.77|6.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.63|0.77|0.1387
73881069|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.71||||0.313|TWO_SIDED|95.0|0.6|4.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.84|0.60|0.3130
73881070|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0392|TWO_SIDED|95.0|1.06|10.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.40|1.06|0.0392
73881071|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0135|TWO_SIDED|95.0|1.43|22.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||22.71|1.43|0.0135
74049195|NCT01855919|147651681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0026|TWO_SIDED|95.0|-0.77|-0.16|||Mixed Models Analysis|||||-0.16|-0.77|0.0026
74049196|NCT01855919|147651682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0026|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|||||-0.10|-0.48|0.0026
74049197|NCT01855919|147651683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.0439|TWO_SIDED|95.0|-1.25|-0.02|||ANCOVA|||||-0.02|-1.25|0.0439
74049198|NCT01855919|147651684|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.101|TWO_SIDED|95.0|-0.66|0.06||p-value is for worst pain|Mixed Models Analysis|||||0.06|-0.66|0.1010
74049199|NCT01855919|147651684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0009|TWO_SIDED|95.0|-0.79|-0.21||p-value is for least pain|Mixed Models Analysis|||||-0.21|-0.79|0.0009
74049200|NCT01855919|147651684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.023|TWO_SIDED|95.0|-0.74|-0.05||p-value is for Pain Right Now|Mixed Models Analysis|||||-0.05|-0.74|0.0230
74049201|NCT01855919|147651684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0874|TWO_SIDED|95.0|-0.66|0.05||p-value is for General Activity|Mixed Models Analysis|||||0.05|-0.66|0.0874
74098176|NCT02792699|147744927|OTHER||Risk Ratio (RR)|0.8373|||||TWO_SIDED|90.0|0.6797|1.0316||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0316|0.6797|
73881072|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.85||||0.084|TWO_SIDED|95.0|0.87|9.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.36|0.87|0.0840
73888108|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|23.3||||0.0738|TWO_SIDED|95.0|-2.3|48.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.9|-2.3|0.0738
74049202|NCT01855919|147651684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0436|TWO_SIDED|95.0|-0.63|-0.01||p-value is for Mood|Mixed Models Analysis|||||-0.01|-0.63|0.0436
74049203|NCT01855919|147651684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.3902|TWO_SIDED|95.0|-0.45|0.18||p-value is for Walking Ability|Mixed Models Analysis|||||0.18|-0.45|0.3902
74049204|NCT01855919|147651684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.33|0.33||p-value is for Normal Work|Mixed Models Analysis|||||0.33|-0.33|0.9910
74049205|NCT01855919|147651684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7848|TWO_SIDED|95.0|-0.3|0.23||p-value is for Relationship People|Mixed Models Analysis|||||0.23|-0.30|0.7848
74049206|NCT01855919|147651684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9424|TWO_SIDED|95.0|-0.32|0.3||p-value is for Sleep|Mixed Models Analysis|||||0.30|-0.32|0.9424
74049207|NCT01855919|147651684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7932|TWO_SIDED|95.0|-0.35|0.27||p-value is for Enjoyment of Life|Mixed Models Analysis|||||0.27|-0.35|0.7932
74049208|NCT01855919|147651684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.3761|TWO_SIDED|95.0|-0.4|0.15||p-value is for Average of 7 Items|Mixed Models Analysis|||||0.15|-0.40|0.3761
74049209|NCT01855919|147651685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0049|TWO_SIDED|95.0|-0.71|-0.13||p-value is for Average Pain|Mixed Models Analysis|||||-0.13|-0.71|0.0049
74049210|NCT01855919|147651685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0442|TWO_SIDED|95.0|-0.69|-0.01||p-value is for Worst pain|Mixed Models Analysis|||||-0.01|-0.69|0.0442
74049211|NCT01855919|147651686|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.31||||0.0003|TWO_SIDED|95.0|1.13|1.53||p-value is for ≥30%|Mantel Haenszel|||||1.53|1.13|0.0003
74049212|NCT01855919|147651686|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43||||0.0003|TWO_SIDED|95.0|1.18|1.75||p-value is for ≥50%|Mantel Haenszel|||||1.75|1.18|0.0003
73881073|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|4.47||||0.0163|TWO_SIDED|95.0|1.32|15.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||15.17|1.32|0.0163
73881074|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5056|TWO_SIDED|95.0|0.52|3.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||3.84|0.52|0.5056
73881075|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.69||||0.3358|TWO_SIDED|95.0|0.58|4.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||4.90|0.58|0.3358
73881076|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0696|TWO_SIDED|95.0|0.91|10.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.18|0.91|0.0696
73881077|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0794|TWO_SIDED|95.0|0.89|8.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.82|0.89|0.0794
73881078|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|7.32||||0.0149|TWO_SIDED|95.0|1.48|36.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.28|1.48|0.0149
73881079|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|4.37||||0.0377|TWO_SIDED|95.0|1.09|17.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||17.59|1.09|0.0377
73881080|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0454|TWO_SIDED|95.0|1.03|10.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.77|1.03|0.0454
73881081|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|3.77||||0.039|TWO_SIDED|95.0|1.07|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.26|1.07|0.0390
73881082|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1947|TWO_SIDED|95.0|0.68|6.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.64|0.68|0.1947
73881083|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.79||||0.2913|TWO_SIDED|95.0|0.61|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.25|0.61|0.2913
73881084|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1665|TWO_SIDED|95.0|0.72|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.82|0.72|0.1665
73881085|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|13.41||||0.0157|TWO_SIDED|95.0|1.63|110.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||110.3|1.63|0.0157
73881086|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0846|TWO_SIDED|95.0|0.86|10.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.49|0.86|0.0846
73881087|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0171|TWO_SIDED|95.0|1.35|21.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||21.75|1.35|0.0171
73881088|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|4.71||||0.0262|TWO_SIDED|95.0|1.2|18.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.49|1.20|0.0262
73881089|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.88||||0.2858|TWO_SIDED|95.0|0.59|5.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.95|0.59|0.2858
73881090|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|7.65||||0.0155|TWO_SIDED|95.0|1.47|39.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||39.72|1.47|0.0155
73888109|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|13.4||||0.2987|TWO_SIDED|95.0|-12.0|38.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.7|-12.0|0.2987
73881091|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.66||||0.1249|TWO_SIDED|95.0|0.76|9.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.31|0.76|0.1249
73881092|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0616|TWO_SIDED|95.0|0.94|15.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.82|0.94|0.0616
73881093|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|8.32||||0.0126|TWO_SIDED|95.0|1.58|43.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||43.90|1.58|0.0126
73881094|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0853|TWO_SIDED|95.0|0.85|11.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.23|0.85|0.0853
74098177|NCT02792699|147744927|OTHER||Risk Difference (RD)|-0.0863|||||TWO_SIDED|90.0|-0.2029|0.0302||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0302|-0.2029|
74098178|NCT02792699|147744927|OTHER||Risk Ratio (RR)|1.1191|||||TWO_SIDED|90.0|0.878|1.4264||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4264|0.8780|
74098179|NCT02792699|147744927|OTHER||Risk Difference (RD)|0.0288|||||TWO_SIDED|90.0|-0.0827|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1402|-0.0827|
74098180|NCT02792699|147744927|OTHER||Risk Ratio (RR)|0.8376|||||TWO_SIDED|90.0|0.6807|1.0307||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0307|0.6807|
74098181|NCT02792699|147744927|OTHER||Risk Difference (RD)|-0.0781|||||TWO_SIDED|90.0|-0.2014|0.0452||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0452|-0.2014|
74098182|NCT02792699|147744927|OTHER||Risk Ratio (RR)|1.0548|||||TWO_SIDED|90.0|0.8351|1.3321||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3321|0.8351|
74098183|NCT02792699|147744927|OTHER||Risk Difference (RD)|0.0141|||||TWO_SIDED|90.0|-0.1021|0.1303||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1303|-0.1021|
73881095|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.56||||0.1562|TWO_SIDED|95.0|0.7|9.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.35|0.70|0.1562
73881096|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1297|TWO_SIDED|95.0|0.74|10.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.91|0.74|0.1297
73881097|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.34||||0.2001|TWO_SIDED|95.0|0.64|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.55|0.64|0.2001
73881098|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0495|TWO_SIDED|95.0|1.0|73.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||73.70|1.00|0.0495
73881099|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.86||||0.1553|TWO_SIDED|95.0|0.67|12.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.20|0.67|0.1553
73881100|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|7.67||||0.0199|TWO_SIDED|95.0|1.38|42.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||42.67|1.38|0.0199
74098184|NCT02792699|147744928|OTHER||Risk Ratio (RR)|0.5926|||||TWO_SIDED|90.0|0.2818|1.2462||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2462|0.2818|
74098185|NCT02792699|147744928|OTHER||Risk Difference (RD)|-0.0574|||||TWO_SIDED|90.0|-0.1285|0.0136||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0136|-0.1285|
74098186|NCT02792699|147744928|OTHER||Risk Ratio (RR)|0.7476|||||TWO_SIDED|90.0|0.3383|1.6519||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.6519|0.3383|
74098187|NCT02792699|147744928|OTHER||Risk Difference (RD)|-0.0327|||||TWO_SIDED|90.0|-0.0962|0.0308||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0308|-0.0962|
74098188|NCT02792699|147744928|OTHER||Risk Ratio (RR)|0.6346|||||TWO_SIDED|90.0|0.3704|1.0872||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0872|0.3704|
74098189|NCT02792699|147744928|OTHER||Risk Difference (RD)|-0.0569|||||TWO_SIDED|90.0|-0.1448|0.031||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0310|-0.1448|
74098190|NCT02792699|147744928|OTHER||Risk Ratio (RR)|0.7857|||||TWO_SIDED|90.0|0.445|1.3874||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3874|0.4450|
74098191|NCT02792699|147744928|OTHER||Risk Difference (RD)|-0.0417|||||TWO_SIDED|90.0|-1237.0|0.0403||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0403|-1237|
74098192|NCT02792699|147744928|OTHER||Risk Ratio (RR)|0.9254|||||TWO_SIDED|90.0|0.5772|1.4838||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4838|0.5772|
74098193|NCT02792699|147744928|OTHER||Risk Difference (RD)|0.0156|||||TWO_SIDED|90.0|-0.078|0.1092||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1092|-0.0780|
74098194|NCT02792699|147744928|OTHER||Risk Ratio (RR)|1.112|||||TWO_SIDED|90.0|0.6722|1.8398||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.8398|0.6722|
73881101|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0472|TWO_SIDED|95.0|1.02|27.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||27.34|1.02|0.0472
73881102|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3736|TWO_SIDED|95.0|0.51|5.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.98|0.51|0.3736
73881103|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.06||||0.2628|TWO_SIDED|95.0|0.58|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.26|0.58|0.2628
73888110|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.0763|TWO_SIDED|95.0|-2.4|48.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.2|-2.4|0.0763
74098195|NCT02792699|147744928|OTHER||Risk Difference (RD)|0.0244|||||TWO_SIDED|90.0|-0.063|0.1119||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1119|-0.0630|
74098196|NCT02792699|147744928|OTHER||Risk Ratio (RR)|0.9798|||||TWO_SIDED|90.0|0.6675|1.4384||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4384|0.6675|
74098197|NCT02792699|147744928|OTHER||Risk Difference (RD)|0.0375|||||TWO_SIDED|90.0|-0.0707|0.1456||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1456|-0.0707|
74098198|NCT02792699|147744928|OTHER||Risk Ratio (RR)|1.1831|||||TWO_SIDED|90.0|0.7833|1.787||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.7870|0.7833|
73881104|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.43||||0.1998|TWO_SIDED|95.0|0.63|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.39|0.63|0.1998
73881105|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.89||||0.1507|TWO_SIDED|95.0|0.68|12.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.28|0.68|0.1507
73881106|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.92||||0.0385|TWO_SIDED|95.0|1.1|31.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||31.94|1.10|0.0385
73881107|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|10.85||||0.0299|TWO_SIDED|95.0|1.26|93.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||93.28|1.26|0.0299
73881108|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.19||||0.8034|TWO_SIDED|95.0|0.3|4.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.74|0.30|0.8034
73881109|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8532|TWO_SIDED|95.0|0.29|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.42|0.29|0.8532
73881110|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8823|TWO_SIDED|95.0|0.28|4.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.41|0.28|0.8823
73881111|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|4.79||||0.1651|TWO_SIDED|95.0|0.52|43.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||43.76|0.52|0.1651
73881112|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|6.36||||0.1048|TWO_SIDED|95.0|0.68|59.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||59.55|0.68|0.1048
74049213|NCT01855919|147651687|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.33||||0.0012|TWO_SIDED|95.0|1.12|1.58|||Mantel Haenszel|||||1.58|1.12|0.0012
74049214|NCT01855919|147651688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0019|TWO_SIDED|95.0|-0.46|-0.1|||Mixed Models Analysis|||||-0.10|-0.46|0.0019
74049215|NCT01855919|147651689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.3012|TWO_SIDED|95.0|-1.03|0.32|||ANCOVA|||||0.32|-1.03|0.3012
74098199|NCT02792699|147744928|OTHER||Risk Difference (RD)|0.0752|||||TWO_SIDED|90.0|-0.0297|0.1802||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1802|-0.0297|
73881113|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.87||||0.1168|TWO_SIDED|95.0|0.64|53.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.53|0.64|0.1168
73881114|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6936|TWO_SIDED|95.0|0.35|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.95|0.35|0.6936
73881115|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4315|TWO_SIDED|95.0|0.44|6.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.90|0.44|0.4315
73881116|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7936|TWO_SIDED|95.0|0.31|4.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.53|0.31|0.7936
74049216|NCT01855919|147651690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27||||0.2581|TWO_SIDED|95.0|-0.93|3.47||p-value for Physical Functioning|ANCOVA|||||3.47|-0.93|0.2581
74049217|NCT01855919|147651690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.7208|TWO_SIDED|95.0|-2.62|3.79||p-value for Role (Physical)|ANCOVA|||||3.79|-2.62|0.7208
74049218|NCT01855919|147651690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.55||||0.2487|TWO_SIDED|95.0|-1.09|4.19||p-value for Bodily Pain|ANCOVA|||||4.19|-1.09|0.2487
74049219|NCT01855919|147651690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94||||0.0151|TWO_SIDED|95.0|0.57|5.31||p-value for General Health|ANCOVA|||||5.31|0.57|0.0151
74049220|NCT01855919|147651690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.4|TWO_SIDED|95.0|-1.54|3.85||p-value for Vitality|ANCOVA|||||3.85|-1.54|0.4000
74049221|NCT01855919|147651690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63||||0.2529|TWO_SIDED|95.0|-1.17|4.43||p-value for Social Functioning|ANCOVA|||||4.43|-1.17|0.2529
74049222|NCT01855919|147651690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8042|TWO_SIDED|95.0|-3.55|2.75||p-value for Role(Emotional)|ANCOVA|||||2.75|-3.55|0.8042
73881117|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|6.3||||0.099|TWO_SIDED|95.0|0.71|56.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||56.03|0.71|0.0990
73881118|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.86||||0.1128|TWO_SIDED|95.0|0.66|52.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||52.21|0.66|0.1128
74049223|NCT01855919|147651690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21||||0.0058|TWO_SIDED|95.0|0.94|5.48||p-value is for Mental Health|ANCOVA|||||5.48|0.94|0.0058
74049224|NCT01855919|147651691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.5237|TWO_SIDED|95.0|-0.02|0.03|||ANCOVA|||||0.03|-0.02|0.5237
74049225|NCT01855919|147651692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.046|TWO_SIDED|95.0|-0.05|0.0||p-value for Work time missed|ANCOVA|||||0.00|-0.05|0.0460
74049226|NCT01855919|147651692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.0753|TWO_SIDED|95.0|-0.08|0.0||p-value for Impairment at work|ANCOVA|||||0.00|-0.08|0.0753
74049227|NCT01855919|147651692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.0795|TWO_SIDED|95.0|-0.08|0.0||p-value for Work productivity loss|ANCOVA|||||0.00|-0.08|0.0795
74049228|NCT01855919|147651692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.1466|TWO_SIDED|95.0|-0.06|0.01||p-value for Work activity impairment|ANCOVA|||||0.01|-0.06|0.1466
74049229|NCT03455530|147651700|SUPERIORITY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|0.45|1.19|||Mixed Models Analysis||Ratio based on the mean difference from the log scale.|||1.19|0.45|
74049230|NCT03455530|147651700|SUPERIORITY||Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|0.55|3.24|||Mixed Models Analysis||Ratio based on the mean difference from the log scale.|||3.24|0.55|
74049231|NCT00908895|147651745|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|70.0|STANDARD_DEVIATION|25.0|<|0.05||95.0|||||Chi-squared|||We assess that 15% is a significative strength difference. According to a 80% study power, a SD at 25% and a 20% lost to follow-up, we found 118 patients for the all study.||||<0.05
74049232|NCT00908895|147651746|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|90.0|STANDARD_DEVIATION|10.0|<|0.05||95.0|80.0|100.0|||Chi-squared|||||100|80|<0.05
74049233|NCT02059174|147651750|NON_INFERIORITY_OR_EQUIVALENCE|A frailty model was used with effects for treatment, period and sequence and a random effect for participant. A value of 1.00 for the hazard ratio corresponds to no difference between treatments.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.72|1.59|||||ratio (MK-1293 / EU-Approved Lantus)|Because numerous participants did not achieve End of Action within the 30-hour clamp timeframe, the pre-specified hypothesis of similarity with regard to mean DOA could not be tested and a survival analysis approach was undertaken. The hazard rate is a measure of the instantaneous risk of reaching End of Action at time t given End of Action has not been met up until time t, with the hazard ratio being an estimate of the relative difference in hazard rates between treatments.||1.59|0.72|
74049234|NCT02059174|147651751|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.95|||||TWO_SIDED|95.0|0.88|1.01|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.01|0.88|
74049235|NCT02059174|147651752|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.9|||||TWO_SIDED|95.0|0.81|0.99|||||Ratio (MK-1293 / EU-Approved Lantus)|||0.99|0.81|
74049236|NCT02059174|147651753|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.06|0.92|
74049237|NCT02059174|147651754|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.96|||||TWO_SIDED|95.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.02|0.91|
74049238|NCT02059174|147651755|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.02|0.91|
74049239|NCT02059174|147651756|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.03|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.03|0.93|
74049240|NCT02059174|147651757|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.86|0.97|||||Ratio (MK-1293 / EU-Approved Lantus)|||0.97|0.86|
74049241|NCT02059174|147651758|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|1.0|||||TWO_SIDED|90.0|0.95|1.04|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.04|0.95|
74049242|NCT01901809|147651770|SUPERIORITY||Mean Difference (Net)|11.4|STANDARD_ERROR_OF_MEAN|4.7||0.018|TWO_SIDED|95.0|2.0|20.8|||t-test, 2 sided|||||20.8|2.0|0.018
74049243|NCT01901809|147651771|SUPERIORITY||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|4.8||0.33|TWO_SIDED|95.0|-14.4|4.9|||t-test, 2 sided|||||4.9|-14.4|0.33
74049244|NCT00087594|147651772|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|95.0|-27.8|41.3||||||95% CI for G1 participants||41.3|-27.8|
74049245|NCT00087594|147651772|SUPERIORITY_OR_OTHER||Difference|13.0|||||TWO_SIDED|95.0|-10.4|35.4||||||95% CI for G2/3 participants||35.4|-10.4|
74049246|NCT00087594|147651772|SUPERIORITY_OR_OTHER||Difference|44.0|||||TWO_SIDED|95.0|12.0|76.9||||||95% CI for G1 participants with 2 log drop at W 12||76.9|12.0|
74049247|NCT00087594|147651772|SUPERIORITY_OR_OTHER||Difference|0.0|||||TWO_SIDED|||||||||95% CI for G1 participants with non 2 log drop at W 12||||
73881119|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|7.36||||0.0732|TWO_SIDED|95.0|0.83|65.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||65.38|0.83|0.0732
73881120|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.39||||0.6559|TWO_SIDED|95.0|0.33|5.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.91|0.33|0.6559
73881121|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7333|TWO_SIDED|95.0|0.21|2.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.96|0.21|0.7333
73881122|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9266|TWO_SIDED|95.0|0.24|3.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.74|0.24|0.9266
73881123|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.04||||0.1518|TWO_SIDED|95.0|0.55|46.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||46.13|0.55|0.1518
73881124|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|4.69||||0.1714|TWO_SIDED|95.0|0.51|42.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||42.91|0.51|0.1714
73881125|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.6||||0.1299|TWO_SIDED|95.0|0.6|51.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||51.95|0.60|0.1299
73881126|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.75||||0.2495|TWO_SIDED|95.0|0.49|15.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.44|0.49|0.2495
73881127|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.32||||0.7065|TWO_SIDED|95.0|0.31|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.60|0.31|0.7065
73881128|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7504|TWO_SIDED|95.0|0.3|5.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.24|0.30|0.7504
73881129|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7862|TWO_SIDED|95.0|0.21|3.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.29|0.21|0.7862
73881130|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|4.98||||0.155|TWO_SIDED|95.0|0.54|45.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||45.59|0.54|0.1550
73881131|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|4.7||||0.1706|TWO_SIDED|95.0|0.51|42.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||42.96|0.51|0.1706
73881132|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.31||||0.1415|TWO_SIDED|95.0|0.57|49.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||49.11|0.57|0.1415
73881133|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.67||||0.1241|TWO_SIDED|95.0|0.62|51.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||51.74|0.62|0.1241
74049248|NCT00087594|147651772|SUPERIORITY_OR_OTHER||Difference|-13.0|||||TWO_SIDED|95.0|-77.2|50.5||||||95% CI for G1 participants with missing HCV-RNA at W 12||50.5|-77.2|
73881134|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.64||||0.2169|TWO_SIDED|95.0|0.57|12.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.29|0.57|0.2169
74049249|NCT01952041|147651786|SUPERIORITY|||||||0.8|||||||Chi-squared|Chi-square test statistic=0.06, degrees of freedom=2||||||0.80
74049250|NCT01952041|147651787|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.43|TWO_SIDED|95.0|0.42|1.44|||Regression, Cox||Hazard ratio is intervention arm vs. TAU for time to first relapse from randomization. There is not a standard error (SE) that directly links to the hazard ratio. The confidence interval provided illustrates the dispersion for the hazard ratio.|||1.44|0.42|0.43
74049251|NCT01952041|147651788|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.41||0.58|TWO_SIDED|95.0|-0.58|1.02|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||1.02|-0.58|0.58
74049252|NCT01952041|147651789|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.84|TWO_SIDED|95.0|-0.22|0.26|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||0.26|-0.22|0.84
74049253|NCT01952041|147651790|SUPERIORITY||Slope|-2.7|STANDARD_ERROR_OF_MEAN|1.4||0.06|TWO_SIDED|95.0|-5.4|0.04|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||0.04|-5.40|0.06
74098200|NCT02792699|147744928|OTHER||Risk Ratio (RR)|0.7027|||||TWO_SIDED|90.0|0.493|1.0017||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0017|0.4930|
74098201|NCT02792699|147744928|OTHER||Risk Difference (RD)|-0.0908|||||TWO_SIDED|90.0|-0.211|0.0294||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0294|-0.2110|
74098202|NCT02792699|147744928|OTHER||Risk Ratio (RR)|1.1449|||||TWO_SIDED|90.0|0.7601|1.7246||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.7246|0.7601|
74098203|NCT02792699|147744928|OTHER||Risk Difference (RD)|0.0277|||||TWO_SIDED|90.0|-0.0804|0.1357||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1357|-0.0804|
74098204|NCT02792699|147744929|OTHER||LS Mean Difference|-1.999|||||TWO_SIDED|90.0|-7.673|3.675||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.675|-7.673|
74098205|NCT02792699|147744929|OTHER||LS Mean Difference|0.544|||||TWO_SIDED|90.0|-5.185|6.274||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||6.274|-5.185|
74098206|NCT02792699|147744929|OTHER||LS Mean Difference|-8.224|||||TWO_SIDED|90.0|-14.102|-2.346||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||-2.346|-14.102|
74098207|NCT02792699|147744929|OTHER||LS Mean Difference|-2.06|||||TWO_SIDED|90.0|-8.052|3.933||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.933|-8.052|
74098208|NCT02792699|147744929|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|90.0|-7.62|4.979||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||4.979|-7.620|
74098209|NCT02792699|147744929|OTHER||LS Mean Difference|0.73|||||TWO_SIDED|90.0|-5.691|7.15||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||7.150|-5.691|
74098210|NCT02792699|147744929|OTHER||LS Mean Difference|-2.207|||||TWO_SIDED|90.0|-8.562|1.417||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||1.417|-8.562|
74098211|NCT02792699|147744929|OTHER||LS Mean Difference|-0.036|||||TWO_SIDED|90.0|-6.497|6.424||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||6.424|-6.497|
74098212|NCT02792699|147744929|OTHER||LS Mean Difference|-6.629|||||TWO_SIDED|90.0|-13.455|0.197||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.197|-13.455|
74098213|NCT02792699|147744929|OTHER||LS Mean Difference|-3.096|||||TWO_SIDED|90.0|-9.883|3.691||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.691|-9.883|
74098214|NCT02792699|147744930|OTHER||Risk Difference (RD)|-0.0245|||||TWO_SIDED|90.0|-0.1083|0.0593|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.|||0.0593|-0.1083|
73881135|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9982|TWO_SIDED|95.0|0.28|3.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.60|0.28|0.9982
74098215|NCT02792699|147744930|OTHER||Risk Difference (RD)|0.0187|||||TWO_SIDED|90.0|-0.061|0.0984|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.|||0.0984|-0.0610|
74098216|NCT01755767|147744935|SUPERIORITY|||||||0.8006|||||||Log Rank|Stratified log rank between treatment arms adjusted for stratification factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||||0.8006
74098217|NCT01755767|147744935|SUPERIORITY||Hazard Ratio (HR)|0.9682||||0.8061|TWO_SIDED|95.0|0.7483|1.2529|||Regression, Cox|Stratified Cox Regression between treatment arms adjusted for factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||1.2529|0.7483|0.8061
74098218|NCT01755767|147744937|SUPERIORITY|||||||0.7509|||||||Log Rank|Stratified log rank between treatment arms adjusted for stratification factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||||0.7509
74098219|NCT01755767|147744937|SUPERIORITY||Hazard Ratio (HR)|0.9557||||0.716|TWO_SIDED|95.0|0.7487|1.22|||Regression, Cox|Stratified Cox regression between treatment arms adjusted for factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||1.2200|0.7487|0.7160
74098220|NCT03464630|147744940|SUPERIORITY|||||||0.503||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.503
74098221|NCT03464630|147744941|SUPERIORITY||||||<|0.001||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||<0.001
74098222|NCT03464630|147744942|SUPERIORITY|||||||0.059||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.059
74098223|NCT03464630|147744943|SUPERIORITY|||||||0.702||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.702
74098224|NCT03464630|147744944|SUPERIORITY|||||||0.08||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.08
74098225|NCT03464630|147744945|SUPERIORITY|||||||0.09||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.09
74098226|NCT03464630|147744946|SUPERIORITY|||||||0.898||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.898
74098227|NCT03464630|147744947|SUPERIORITY|||||||0.349||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.349
74098228|NCT03464630|147744948|SUPERIORITY||||||<|0.001||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||<0.001
74098229|NCT00191165|147744949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45||||0.34||95.0|-0.5|1.4|||ANOVA||Mean Difference = High Dose - Label Dose|||1.40|-0.50|0.340
74098230|NCT00191165|147744950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.388||95.0|-0.21|0.53||P-value for 12-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose|||0.53|-0.21|0.388
74098231|NCT00191165|147744950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.061||95.0|-0.02|0.99||P-value for 24-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose|||0.99|-0.02|0.061
74098232|NCT00191165|147744951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.13||||0.088||95.0|-0.18|2.44|||ANOVA||Mean Difference = High Dose - Label Dose|||2.44|-0.18|0.088
74098233|NCT01338870|147744973|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.145||0.7606|TWO_SIDED|80.0|-0.08|0.29|||Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.29|-0.08|0.7606
74098234|NCT01338870|147744973|SUPERIORITY_OR_OTHER||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0266|TWO_SIDED|80.0|-0.46|-0.09|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.46|0.0266
74098235|NCT01338870|147744973|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.141||0.044|TWO_SIDED|80.0|-0.42|-0.06|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.06|-0.42|0.0440
74098236|NCT01338870|147744973|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.137||0.0001|TWO_SIDED|80.0|-0.71|-0.36|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.36|-0.71|0.0001
74098237|NCT01338870|147744973|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.139||0.0013|TWO_SIDED|80.0|-0.6|-0.25|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.25|-0.60|0.0013
74098238|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-5.21|STANDARD_ERROR_OF_MEAN|5.7||0.3611|TWO_SIDED|95.0|-16.4|5.98|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.98|-16.40|0.3611
74098239|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-9.45|STANDARD_ERROR_OF_MEAN|5.686||0.0969|TWO_SIDED|95.0|-20.61|1.71|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.71|-20.61|0.0969
74098240|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-8.1|STANDARD_ERROR_OF_MEAN|5.71||0.1566|TWO_SIDED|95.0|-19.3|3.11|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.11|-19.30|0.1566
74098241|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-15.92|STANDARD_ERROR_OF_MEAN|5.678||0.0052|TWO_SIDED|95.0|-27.06|-4.77|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.77|-27.06|0.0052
74098242|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-21.09|STANDARD_ERROR_OF_MEAN|5.712||0.0002|TWO_SIDED|95.0|-32.3|-9.88|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-9.88|-32.30|0.0002
74098243|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|5.852||0.9893|TWO_SIDED|95.0|-11.41|11.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.56|-11.41|0.9893
74098244|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-4.14|STANDARD_ERROR_OF_MEAN|5.814||0.4767|TWO_SIDED|95.0|-15.55|7.27|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.27|-15.55|0.4767
74049254|NCT01569568|147651798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PCGM.||||0.001
74049255|NCT01569568|147651798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PCGM.||||0.011
74049256|NCT01569568|147651798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PWM.||||0.004
74049257|NCT01569568|147651798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PWM.||||0.046
74049258|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the DMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all DMN nodes is the same across groups.||||<0.001
74049259|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the left IPL node does not differ between groups.||||0.024
74049260|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold is 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the PCC node does not differ between groups.||||0.040
74049261|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the right IPL node does not differ between groups.||||0.008
74049262|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left IPL node and the right IPL node does not differ between groups.||||0.470
74049263|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.829|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the left IPL node does not differ between groups.||||0.829
74049264|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.801|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the right IPL node does not differ between groups.||||0.801
74049265|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the SMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all SMN nodes is the same across groups.||||<0.001
74049266|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left aI/fO node does not differ between groups.||||0.550
74049267|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left SFG node does not differ between groups.||||0.113
74049268|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right aI/fO node does not differ between groups.||||0.039
74049269|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right SFG node does not differ between groups.||||0.005
74049270|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.426|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the left SFG node does not differ between groups.||||0.426
74049271|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.256|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO node and the right aI/fO node does not differ between groups.||||0.256
74098245|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-2.87|STANDARD_ERROR_OF_MEAN|5.816||0.6222|TWO_SIDED|95.0|-14.28|8.55|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.55|-14.28|0.6222
74098246|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-13.88|STANDARD_ERROR_OF_MEAN|5.744||0.0159|TWO_SIDED|95.0|-25.16|-2.61|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.61|-25.16|0.0159
74098247|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-18.69|STANDARD_ERROR_OF_MEAN|5.735||0.0012|TWO_SIDED|95.0|-29.95|-7.44|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.44|-29.95|0.0012
74098248|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|3.86|STANDARD_ERROR_OF_MEAN|5.895||0.5125|TWO_SIDED|95.0|-7.71|15.43|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||15.43|-7.71|0.5125
74098249|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-8.47|STANDARD_ERROR_OF_MEAN|5.815||0.1455|TWO_SIDED|95.0|-19.89|2.94|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.94|-19.89|0.1455
74098250|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|0.94|STANDARD_ERROR_OF_MEAN|5.794||0.8712|TWO_SIDED|95.0|-10.43|12.31|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.31|-10.43|0.8712
74098251|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-19.57|STANDARD_ERROR_OF_MEAN|5.707||0.0006|TWO_SIDED|95.0|-30.77|-8.36|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-8.36|-30.77|0.0006
74098252|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-19.08|STANDARD_ERROR_OF_MEAN|5.696||0.0008|TWO_SIDED|95.0|-30.26|-7.9|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.90|-30.26|0.0008
73881136|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.57||||0.5364|TWO_SIDED|95.0|0.38|6.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.54|0.38|0.5364
74098253|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|6.99|STANDARD_ERROR_OF_MEAN|6.055||0.2488|TWO_SIDED|95.0|-4.9|18.87|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||18.87|-4.90|0.2488
74098254|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-7.56|STANDARD_ERROR_OF_MEAN|6.004||0.2084|TWO_SIDED|95.0|-19.34|4.23|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.23|-19.34|0.2084
74098255|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|5.971||0.9053|TWO_SIDED|95.0|-11.01|12.43|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.43|-11.01|0.9053
73881137|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.68||||0.121|TWO_SIDED|95.0|0.63|51.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||51.07|0.63|0.1210
74098256|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|5.853||0.0091|TWO_SIDED|95.0|-26.79|-3.81|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.81|-26.79|0.0091
74098257|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-18.62|STANDARD_ERROR_OF_MEAN|5.875||0.0016|TWO_SIDED|95.0|-30.15|-7.09|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.09|-30.15|0.0016
74098258|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|6.5|STANDARD_ERROR_OF_MEAN|6.217||0.2963|TWO_SIDED|95.0|-5.71|18.7|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||18.70|-5.71|0.2963
74098259|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-9.71|STANDARD_ERROR_OF_MEAN|6.17||0.1159|TWO_SIDED|95.0|-21.82|2.4|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.40|-21.82|0.1159
73888111|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.3396|TWO_SIDED|95.0|-13.1|37.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.6|-13.1|0.3396
74098260|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|6.103||0.4413|TWO_SIDED|95.0|-7.28|16.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||16.68|-7.28|0.4413
74098261|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|5.918||0.0099|TWO_SIDED|95.0|-26.91|-3.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.68|-26.91|0.0099
74098262|NCT01338870|147744974|SUPERIORITY_OR_OTHER||LS mean difference|-14.95|STANDARD_ERROR_OF_MEAN|5.981||0.0126|TWO_SIDED|95.0|-26.69|-3.21|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.21|-26.69|0.0126
74098263|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.058||0.1797|TWO_SIDED|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.13|0.1797
74098264|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.058||0.0234|TWO_SIDED|95.0|-0.19|-0.04|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.04|-0.19|0.0234
74098265|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.058||0.04|TWO_SIDED|80.0|-0.18|-0.03|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.03|-0.18|0.0400
74098266|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.057||0.1568|TWO_SIDED|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.13|0.1568
74098267|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.058||0.001|TWO_SIDED|80.0|-0.25|-0.11|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.11|-0.25|0.0010
74098268|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0695|TWO_SIDED|80.0|-0.19|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.01|-0.19|0.0695
74098269|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.069||0.0636|TWO_SIDED|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.20|0.0636
74098270|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.069||0.0512|TWO_SIDED|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.20|0.0512
74098271|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.068||0.0051|TWO_SIDED|80.0|-0.26|-0.09|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.26|0.0051
74098272|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.069||0.0009|TWO_SIDED|80.0|-0.3|-0.13|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.13|-0.30|0.0009
74049272|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.853|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the right SFG node does not differ between groups.||||0.853
73888112|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.2||||0.2425|TWO_SIDED|95.0|-89.1|22.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.7|-89.1|0.2425
74049273|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the left SFG node does not differ between groups.||||0.003
74049274|NCT01569568|147651799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the right SFG node does not differ between groups.||||0.023
74049275|NCT01569568|147651801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.929|TWO_SIDED|||||Equal variance is not assumed. Two tailed t-test WASI verbal IQ between cases and controls|t-test, 2 sided|||||||.929
74049276|NCT01569568|147651801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||Equal variance not assumed. Comparison WASI performance IQ cases and controls|t-test, 2 sided|||||||.002
74049277|NCT01569568|147651801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.094|TWO_SIDED|||||Equal variance not assumed. Comparison of WASI full IQ cases and controls|t-test, 2 sided|||||||.094
74049278|NCT01569568|147651801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.853|TWO_SIDED|||||Equal variance not assumed. Comparison of CTMT global composite score between cases and controls|t-test, 2 sided|||||||.853
74049279|NCT01569568|147651801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||Equal variance not assumed. Comparison of BRIEF BRI cases and controls|t-test, 2 sided|||||||.001
74049280|NCT01569568|147651801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Equal variances not assumed. Comparison of BRIEF MI cases and controls|t-test, 2 sided|||||||<.001
74049281|NCT01569568|147651801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Equal variances not assumed. Comparison of BRIEF GEC between cases and controls.|t-test, 2 sided|||||||<0.001
74049282|NCT00416572|147651827|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||> 0.05
74049283|NCT00416572|147651827|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
74098273|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.094||0.2392|TWO_SIDED|80.0|-0.19|0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.05|-0.19|0.2392
74098274|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.091||0.0308|TWO_SIDED|80.0|-0.29|-0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.05|-0.29|0.0308
74049284|NCT00416572|147651827|SUPERIORITY_OR_OTHER||standardized beta|-0.12|||=|0.08|TWO_SIDED||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.08
74049285|NCT00416572|147651827|SUPERIORITY_OR_OTHER||standardized beta|-0.23|||<|0.001|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||<0.001
74049286|NCT00416572|147651828|SUPERIORITY_OR_OTHER||||||>|0.5|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.50
74049287|NCT00416572|147651828|SUPERIORITY_OR_OTHER||Standardized beta|0.14|||=|0.04|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.04
74049288|NCT00416572|147651828|SUPERIORITY_OR_OTHER||Standardized beta|0.25|||<|0.001|TWO_SIDED||||||Regression, Linear|||Comparison between the education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||<0.001
74049289|NCT00416572|147651828|SUPERIORITY_OR_OTHER||Standardized beta|0.15|||=|0.02|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.02
74049290|NCT00416572|147651829|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome||||>.05
74049291|NCT00416572|147651829|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
74098275|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.091||0.0019|TWO_SIDED|80.0|-0.38|-0.15|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.15|-0.38|0.0019
74098276|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.089||0.0034|TWO_SIDED|80.0|-0.36|-0.13|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.13|-0.36|0.0034
74098277|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0002|TWO_SIDED|80.0|-0.44|-0.21|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.44|0.0002
74098278|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.126||0.7854|TWO_SIDED|80.0|-0.06|0.26|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.26|-0.06|0.7854
74098279|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.123||0.0778|TWO_SIDED|80.0|-0.33|-0.02|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.33|0.0778
74098280|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.122||0.0065|TWO_SIDED|80.0|-0.46|-0.15|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.15|-0.46|0.0065
74098281|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.119||0.0011|TWO_SIDED|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.52|0.0011
74098282|NCT01338870|147744975|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.121||0.0013|TWO_SIDED|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.52|0.0013
74098283|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.272||0.5636|TWO_SIDED|95.0|-0.69|0.38|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.38|-0.69|0.5636
74098284|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.271||0.4889|TWO_SIDED|95.0|-0.35|0.72|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.72|-0.35|0.4889
74098285|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.272||0.5849|TWO_SIDED|95.0|-0.68|0.39|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.39|-0.68|0.5849
74098286|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.268||0.5104|TWO_SIDED|95.0|-0.7|0.35|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.35|-0.70|0.5104
74098287|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.269||0.264|TWO_SIDED|95.0|-0.83|0.23|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.23|-0.83|0.2640
74098288|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.357||0.0464|TWO_SIDED|95.0|-1.42|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.01|-1.42|0.0464
74098289|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.353||0.7107|TWO_SIDED|95.0|-0.83|0.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.56|-0.83|0.7107
74098290|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.352||0.1564|TWO_SIDED|95.0|-1.19|0.19|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.19|-1.19|0.1564
74098291|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.345||0.3834|TWO_SIDED|95.0|-0.98|0.38|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.38|-0.98|0.3834
74098292|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.346||0.1279|TWO_SIDED|95.0|-1.21|0.15|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.15|-1.21|0.1279
74049292|NCT00416572|147651829|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
74049293|NCT00416572|147651829|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
74049294|NCT01654224|147651830|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.005||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.005
74049295|NCT01654224|147651830|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.001||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.001
74049296|NCT01654224|147651830|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.004||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.004
74049297|NCT01654224|147651830|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.672||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.672
74049298|NCT01654224|147651830|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.011||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided|||||||.011
74049299|NCT01654224|147651830|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.01||||||B/Texas/6/2011|t-test, 2 sided|||||||.010
74098293|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.339||0.252|TWO_SIDED|95.0|-1.06|0.28|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.28|-1.06|0.2520
74098294|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.336||0.2772|TWO_SIDED|95.0|-0.3|1.03|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.03|-0.30|0.2772
74049300|NCT01654224|147651831|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.074||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.074
74098295|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.335||0.7038|TWO_SIDED|95.0|-0.79|0.53|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.53|-0.79|0.7038
73888113|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|62.1||||0.0281|TWO_SIDED|95.0|6.8|117.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||117.5|6.8|0.0281
74049301|NCT01654224|147651831|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.006||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.006
74049302|NCT01654224|147651831|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.069||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.069
74049303|NCT01654224|147651831|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.663||||||A/California/07/2009(H3N2)|t-test, 2 sided|||||||.663
74049304|NCT01654224|147651831|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.003||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided|||||||.003
73881138|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|7.65||||0.0726|TWO_SIDED|95.0|0.83|70.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||70.58|0.83|0.0726
74049305|NCT01654224|147651831|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.063||||||B/Texas/6/2011|t-test, 2 sided|||||||.063
74049306|NCT01654224|147651832|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.917||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.917
74049307|NCT01654224|147651832|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.36||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.360
74049308|NCT01654224|147651832|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.248||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.248
74049309|NCT01654224|147651832|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.178||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.178
74049310|NCT01654224|147651832|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.152||||||A/Victoria/361/2011(H1N2)|t-test, 2 sided|||||||.152
74049311|NCT01654224|147651832|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.285||||||B/Texas/6/2011|t-test, 2 sided|||||||.285
74049312|NCT00166504|147651833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.0|STANDARD_DEVIATION|15.3|<|0.001||95.0|-14.3|-5.7|||ANOVA||Direction of the Comparison: Vytorin minus Atorvastatin.|||-5.7|-14.3|<0.001
74049313|NCT00723489|147651834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.86|TWO_SIDED|95.0|-0.3|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.2|-0.3|0.86
74049314|NCT00723489|147651835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.86|TWO_SIDED|95.0|-0.2|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.2|-0.2|0.86
74049315|NCT00723489|147651836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.1|TWO_SIDED|95.0|-0.5|0.05||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.05|-0.5|0.10
74098296|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.329||0.2031|TWO_SIDED|95.0|-1.07|0.23|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.23|-1.07|0.2031
74098297|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.33||0.6948|TWO_SIDED|95.0|-0.78|0.52|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.78|0.6948
74049316|NCT00723489|147651837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.66|TWO_SIDED|95.0|-0.2|0.3||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.3|-0.2|0.66
74049317|NCT00723489|147651838|SUPERIORITY_OR_OTHER|||||||0.24||||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||||||0.24
74049318|NCT00723489|147651839|SUPERIORITY_OR_OTHER|||||||0.43||||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||||||0.43
74049319|NCT00723489|147651840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|0.1||||0.48|TWO_SIDED|95.0|-0.1|0.3||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC -(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing||0.3|-0.1|0.48
74049320|NCT00723489|147651841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|-0.3||||0.036|TWO_SIDED|95.0|-0.5|-0.02||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||-0.02|-0.5|0.036
74049321|NCT00723489|147651842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|0.04||||0.82|TWO_SIDED|95.0|-0.3|0.4||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC -(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing||0.4|-0.3|0.82
74049322|NCT00723489|147651843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|-0.4||||0.045|TWO_SIDED|95.0|-0.7|-0.01||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||-0.01|-0.7|0.045
73881139|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|7.34||||0.0749|TWO_SIDED|95.0|0.82|65.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||65.81|0.82|0.0749
73881140|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|4.01||||0.053|TWO_SIDED|95.0|0.98|16.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.35|0.98|0.0530
73881141|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.32||||0.2134|TWO_SIDED|95.0|0.62|8.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.72|0.62|0.2134
74049323|NCT02274311|147651844|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Measures of central tendency (mean) and variability (range and/or SD) were used to describe numeric variables. Paired Student's t test was used to verify the mean differences between dependent normally distributed variables. Wilcoxon sign test was performed to non-normally distributed dependent variables.~Asignificance level of 5%was adopted for all statistical tests (P \<.05)."||||< 0.05
74049324|NCT00853112|147651856|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-115.0|STANDARD_DEVIATION|98.36||0.12|TWO_SIDED|95.0|-371.5|-1.1|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and standard deviation (SD) from the Bayesian analysis.||-1.1|-371.5|0.120
74049325|NCT00853112|147651856|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-170.6|STANDARD_DEVIATION|107.84||0.25|TWO_SIDED|95.0|-409.2|-7.1|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne.s.m2/cm5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-7.1|-409.2|0.250
73881142|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.88||||0.3688|TWO_SIDED|95.0|0.48|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.41|0.48|0.3688
73881143|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|4.61||||0.0563|TWO_SIDED|95.0|0.96|22.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||22.11|0.96|0.0563
73881144|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0935|TWO_SIDED|95.0|0.79|19.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.52|0.79|0.0935
73881145|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0901|TWO_SIDED|95.0|0.81|16.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.93|0.81|0.0901
74049326|NCT00853112|147651856|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-240.2|STANDARD_DEVIATION|109.28||0.485|TWO_SIDED|95.0|-444.8|-33.8|||Bayesian 4-parameter Emax model.|||The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-33.8|-444.8|0.485
74049327|NCT00853112|147651856|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-327.9|STANDARD_DEVIATION|92.41||0.81|TWO_SIDED|95.0|-492.9|-148.0|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-148.0|-492.9|0.810
74098298|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.421||0.5691|TWO_SIDED|95.0|-1.07|0.59|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|-1.07|0.5691
73881146|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1366|TWO_SIDED|95.0|0.72|11.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.26|0.72|0.1366
73881147|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7876|TWO_SIDED|95.0|0.34|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.08|0.34|0.7876
73888114|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.4189|TWO_SIDED|95.0|-33.0|78.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||78.8|-33.0|0.4189
74049328|NCT00853112|147651856|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-379.4|STANDARD_DEVIATION|73.61||0.974|TWO_SIDED|95.0|-520.6|-238.8|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. Posterior distribution was calculated and was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-238.8|-520.6|0.974
74049329|NCT00853112|147651857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-195.3|STANDARD_ERROR_OF_MEAN|207.38||0.354|TWO_SIDED|95.0|-618.8|228.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using Analysis of Covariance (ANCOVA) with baseline fitted as a covariate.||228.3|-618.8|0.354
74049330|NCT00853112|147651857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-34.1|STANDARD_ERROR_OF_MEAN|190.99||0.86|TWO_SIDED|95.0|-424.1|356.0|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||356.0|-424.1|0.860
74049331|NCT00853112|147651857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-435.7|STANDARD_ERROR_OF_MEAN|195.94||0.034|TWO_SIDED|95.0|-835.9|-35.6|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||-35.6|-835.9|0.034
74049332|NCT00853112|147651857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-334.7|STANDARD_ERROR_OF_MEAN|201.74||0.107|TWO_SIDED|95.0|-746.7|77.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||77.3|-746.7|0.107
73881148|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4658|TWO_SIDED|95.0|0.45|5.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.59|0.45|0.4658
74049333|NCT00853112|147651857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-278.0|STANDARD_ERROR_OF_MEAN|200.89||0.177|TWO_SIDED|95.0|-688.3|132.2|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||132.2|-688.3|0.177
74049334|NCT00853112|147651857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.1|STANDARD_ERROR_OF_MEAN|315.91||0.873|TWO_SIDED|95.0|-594.1|696.3|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||696.3|-594.1|0.873
74049335|NCT00853112|147651857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|75.2|STANDARD_ERROR_OF_MEAN|303.08||0.806|TWO_SIDED|95.0|-543.8|694.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||694.1|-543.8|0.806
74049336|NCT00853112|147651857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-262.8|STANDARD_ERROR_OF_MEAN|301.1||0.39|TWO_SIDED|95.0|-877.8|352.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||352.1|-877.8|0.390
74098299|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.415||0.3447|TWO_SIDED|95.0|-0.42|1.21|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.21|-0.42|0.3447
74098300|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.413||0.5769|TWO_SIDED|95.0|-1.04|0.58|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.58|-1.04|0.5769
74098301|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.402||0.3599|TWO_SIDED|95.0|-1.16|0.42|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.42|-1.16|0.3599
74098302|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.407||0.46|TWO_SIDED|95.0|-1.1|0.5|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.50|-1.10|0.4600
74098303|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.504||0.4253|TWO_SIDED|95.0|-1.39|0.59|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|-1.39|0.4253
74098304|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.497||0.4349|TWO_SIDED|95.0|-0.59|1.37|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.37|-0.59|0.4349
74098305|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.492||0.6697|TWO_SIDED|95.0|-1.18|0.76|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.76|-1.18|0.6697
74098306|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.476||0.5501|TWO_SIDED|95.0|-1.22|0.65|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.65|-1.22|0.5501
74098307|NCT01338870|147744977|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.484||0.4081|TWO_SIDED|95.0|-1.35|0.55|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.55|-1.35|0.4081
74098308|NCT00423319|147744989|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.22|0.54||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||0.54|0.22|<0.0001
74098309|NCT00423319|147744989|SUPERIORITY_OR_OTHER||Risk Difference|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.54|1.5||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||1.50|-3.54|<0.0001
73881149|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8707|TWO_SIDED|95.0|0.25|3.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.20|0.25|0.8707
73881150|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.89||||0.3584|TWO_SIDED|95.0|0.49|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.36|0.49|0.3584
73881151|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|3.13||||0.1455|TWO_SIDED|95.0|0.67|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||14.57|0.67|0.1455
74049337|NCT00853112|147651857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-329.4|STANDARD_ERROR_OF_MEAN|302.97||0.286|TWO_SIDED|95.0|-948.1|289.4|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||289.4|-948.1|0.286
74049338|NCT00853112|147651857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.7|STANDARD_ERROR_OF_MEAN|314.15||0.843|TWO_SIDED|95.0|-704.3|578.9|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||578.9|-704.3|0.843
74049339|NCT00853112|147651858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|322.8||0.999|TWO_SIDED|95.0|-659.7|658.8|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||658.8|-659.7|0.999
74049340|NCT00853112|147651858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|72.2|STANDARD_ERROR_OF_MEAN|309.69||0.817|TWO_SIDED|95.0|-560.2|704.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||704.7|-560.2|0.817
74049341|NCT00853112|147651858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-82.6|STANDARD_ERROR_OF_MEAN|307.67||0.79|TWO_SIDED|95.0|-711.0|545.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||545.7|-711.0|0.790
74049342|NCT00853112|147651858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-325.6|STANDARD_ERROR_OF_MEAN|309.58||0.301|TWO_SIDED|95.0|-957.8|306.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||306.7|-957.8|0.301
74049343|NCT00853112|147651858|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.2|STANDARD_ERROR_OF_MEAN|321.0||0.85|TWO_SIDED|95.0|-716.8|594.4|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||594.4|-716.8|0.850
74049344|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-269.32|STANDARD_ERROR_OF_MEAN|252.93||0.295|TWO_SIDED|95.0|-785.39|246.76|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||246.76|-785.39|0.295
74098310|NCT00423319|147744990|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.15|0.8||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||0.80|0.15|<0.0001
74098311|NCT00423319|147744990|SUPERIORITY_OR_OTHER||Risk difference|-0.68||||0.0054|TWO_SIDED|95.0|-1.27|-0.17||Statistically significant at the 1-sided 0.025 level|Chi-squared||Apixaban-enoxaparin|||-0.17|-1.27|0.0054
74098312|NCT00423319|147744992|SUPERIORITY_OR_OTHER||Difference in event rates|0.15||||0.54|TWO_SIDED|95.0|-0.33|0.64||2-sided P-Value|Chi-squared||Major bleeding. Apixaban-enoxaparin|||0.64|-0.33|0.54
73881152|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0661|TWO_SIDED|95.0|0.9|28.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||28.66|0.90|0.0661
74098313|NCT00423319|147744992|SUPERIORITY_OR_OTHER||Difference in event rates|-0.44||||0.43|TWO_SIDED|95.0|-1.53|0.66||2-sided P-Value|Chi-squared||CRNM. Apixaban-enoxaparin|||0.66|-1.53|0.43
74098314|NCT00423319|147744992|SUPERIORITY_OR_OTHER||Difference in event rates|-0.21||||0.72|TWO_SIDED|95.0|-1.38|0.95||2-sided P-Value|Chi-squared||Major or CRNM. Apixaban-enoxaparin|||0.95|-1.38|0.72
74098315|NCT00423319|147744992|SUPERIORITY_OR_OTHER||Difference in event rate|-0.85||||0.34|TWO_SIDED|95.0|-2.61|0.9||2-sided P-Value|Chi-squared||Any bleeding. Apixaban-enoxaparin|||0.90|-2.61|0.34
74049345|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-97.65|STANDARD_ERROR_OF_MEAN|234.55||0.68|TWO_SIDED|95.0|-577.02|381.72|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||381.72|-577.02|0.680
74049346|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-376.61|STANDARD_ERROR_OF_MEAN|241.06||0.129|TWO_SIDED|95.0|-869.53|116.31|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||116.31|-869.53|0.129
74049347|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-342.29|STANDARD_ERROR_OF_MEAN|247.07||0.176|TWO_SIDED|95.0|-846.9|162.32|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||162.32|-846.90|0.176
74049348|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-316.86|STANDARD_ERROR_OF_MEAN|261.58||0.235|TWO_SIDED|95.0|-850.9|217.17|||Longitudinal analysis|||Hour 1: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.||217.17|-850.90|0.235
74049349|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-198.06|STANDARD_ERROR_OF_MEAN|247.62||0.43|TWO_SIDED|95.0|-705.04|308.91|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||308.91|-705.04|0.430
74049350|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.9|STANDARD_ERROR_OF_MEAN|229.23||0.87|TWO_SIDED|95.0|-432.23|508.04|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||508.04|-432.23|0.870
74049351|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-114.06|STANDARD_ERROR_OF_MEAN|244.95||0.645|TWO_SIDED|95.0|-614.57|386.45|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||386.45|-614.57|0.645
74098316|NCT00423319|147745002|SUPERIORITY_OR_OTHER||Difference in event rates|-0.04|||||TWO_SIDED|95.0|-0.34|0.26|||||Apixaban-enoxaparin. MI/stroke|||0.26|-0.34|
73881153|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.97||||0.3034|TWO_SIDED|95.0|0.54|7.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.17|0.54|0.3034
73881154|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9901|TWO_SIDED|95.0|0.28|3.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.60|0.28|0.9901
73881155|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.55||||0.507|TWO_SIDED|95.0|0.42|5.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.68|0.42|0.5070
73881156|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7927|TWO_SIDED|95.0|0.21|3.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.26|0.21|0.7927
73881157|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4426|TWO_SIDED|95.0|0.44|6.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||6.69|0.44|0.4426
73881158|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8925|TWO_SIDED|95.0|0.23|3.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.56|0.23|0.8925
73881159|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.79||||0.4285|TWO_SIDED|95.0|0.42|7.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.52|0.42|0.4285
73881160|NCT03192176|147297629|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9|TWO_SIDED|95.0|0.31|3.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.72|0.31|0.9000
74049352|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-299.6|STANDARD_ERROR_OF_MEAN|241.63||0.225|TWO_SIDED|95.0|-794.81|195.61|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||195.61|-794.81|0.225
74049353|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-332.25|STANDARD_ERROR_OF_MEAN|255.93||0.205|TWO_SIDED|95.0|-856.55|192.05|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||192.05|-856.55|0.205
73881161|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0602|TWO_SIDED|95.0|0.96|6.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.06|0.96|0.0602
74049354|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.72|STANDARD_ERROR_OF_MEAN|263.63||0.745|TWO_SIDED|95.0|-625.87|452.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||452.42|-625.87|0.745
74098317|NCT00423319|147745002|SUPERIORITY_OR_OTHER||Difference in event rates|0.07|||||TWO_SIDED|95.0|-0.17|0.34|||||Apixaban-enoxaparin. MI|||0.34|-0.17|
73881162|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|4.88||||0.001|TWO_SIDED|95.0|1.89|12.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.57|1.89|0.0010
73881163|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|5.24||||0.0006|TWO_SIDED|95.0|2.03|13.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||13.51|2.03|0.0006
73881164|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|9.07|||<|0.0001|TWO_SIDED|95.0|3.23|25.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.45|3.23|<0.0001
73881165|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1259|TWO_SIDED|95.0|0.82|5.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.22|0.82|0.1259
73881166|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|7.05|||<|0.0001|TWO_SIDED|95.0|2.65|18.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.71|2.65|<0.0001
74049355|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|18.0|STANDARD_ERROR_OF_MEAN|245.25||0.942|TWO_SIDED|95.0|-484.46|520.47|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||520.47|-484.46|0.942
74049356|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-265.94|STANDARD_ERROR_OF_MEAN|259.53||0.314|TWO_SIDED|95.0|-796.15|264.28|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||264.28|-796.15|0.314
74098318|NCT00423319|147745002|SUPERIORITY_OR_OTHER||Difference in event rates|-0.11|||||TWO_SIDED|95.0|-0.35|0.07|||||Apixaban-enoxaparin. Stroke|||0.07|-0.35|
74098319|NCT00423319|147745002|SUPERIORITY_OR_OTHER||Difference in event rates|-0.04|||||TWO_SIDED|95.0|-0.26|0.17|||||Apixaban-enoxaparin. Thrombocytopenia|||0.17|-0.26|
74098320|NCT02348723|147745005|SUPERIORITY_OR_OTHER||Risk Difference (RD) %|-5.3||||0.0009|TWO_SIDED|95.0|-8.4|-2.2|||Chi-squared|||The risk difference between dabigatran etexilate vs. warfarin, its 2-sided 95% CI, and corresponding p-value are presented.||-2.2|-8.4|0.0009
74098321|NCT00678886|147745010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.813|TWO_SIDED|95.0|-0.06|0.08|||Mixed effects repeated measures model|||Mixed meal-stimulated C-peptide AUC, Placebo Vs Otelixizumab at Month 12||0.08|-0.06|0.813
74098322|NCT00678886|147745011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.737|TWO_SIDED|95.0|0.47|1.7|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Week 12||1.70|0.47|0.737
73881167|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.51||||0.007|TWO_SIDED|95.0|1.41|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.76|1.41|0.0070
73881168|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0193|TWO_SIDED|95.0|1.2|8.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.23|1.20|0.0193
73881169|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.34||||0.0148|TWO_SIDED|95.0|1.27|8.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.81|1.27|0.0148
73881170|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0018|TWO_SIDED|95.0|1.83|13.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.94|1.83|0.0018
73881171|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|7.27||||0.0007|TWO_SIDED|95.0|2.32|22.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||22.78|2.32|0.0007
73881172|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0246|TWO_SIDED|95.0|1.16|8.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.35|1.16|0.0246
73881173|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|5.22||||0.0016|TWO_SIDED|95.0|1.87|14.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.60|1.87|0.0016
73881174|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0825|TWO_SIDED|95.0|0.9|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.62|0.90|0.0825
74049357|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-275.35|STANDARD_ERROR_OF_MEAN|258.01||0.295|TWO_SIDED|95.0|-803.57|252.88|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||252.88|-803.57|0.295
74049358|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-326.55|STANDARD_ERROR_OF_MEAN|272.96||0.241|TWO_SIDED|95.0|-885.12|232.02|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||232.02|-885.12|0.241
74098323|NCT00678886|147745011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.737|TWO_SIDED|95.0|0.42|1.39|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 6||1.39|0.42|0.737
74098324|NCT00678886|147745011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.481|TWO_SIDED|95.0|0.45|1.46|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 12||1.46|0.45|0.481
73881175|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0542|TWO_SIDED|95.0|0.98|7.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.20|0.98|0.0542
73881176|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0837|TWO_SIDED|95.0|0.89|6.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.33|0.89|0.0837
73881177|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0131|TWO_SIDED|95.0|1.31|10.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.26|1.31|0.0131
73881178|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|9.34||||0.0012|TWO_SIDED|95.0|2.41|36.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.19|2.41|0.0012
74098325|NCT00678886|147745012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.281|TWO_SIDED|95.0|-0.07|0.01|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Week 12||0.01|-0.07|0.281
74098326|NCT00678886|147745012|SUPERIORITY||Mean Difference (Net)|0.0||||0.969|TWO_SIDED|95.0|-0.05|0.05|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 6||0.05|-0.05|0.969
73881179|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0359|TWO_SIDED|95.0|1.08|8.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.93|1.08|0.0359
74049359|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-145.71|STANDARD_ERROR_OF_MEAN|218.5||0.51|TWO_SIDED|95.0|-592.24|300.83|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||300.83|-592.24|0.510
73881180|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0019|TWO_SIDED|95.0|1.91|17.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||17.92|1.91|0.0019
73881181|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0715|TWO_SIDED|95.0|0.93|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.38|0.93|0.0715
73881182|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0465|TWO_SIDED|95.0|1.02|8.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.20|1.02|0.0465
73881183|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0839|TWO_SIDED|95.0|0.89|6.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.53|0.89|0.0839
74098327|NCT00678886|147745012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.272|TWO_SIDED|95.0|-0.08|0.02|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 12||0.02|-0.08|0.272
74098328|NCT00678886|147745013|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.18||||0.289|TWO_SIDED|95.0|-0.16|0.52|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 12||0.52|-0.16|0.289
74098329|NCT00678886|147745013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.538|TWO_SIDED|95.0|-0.15|0.49|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 6||0.49|-0.15|0.538
74098330|NCT00678886|147745013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.538|TWO_SIDED|95.0|-0.19|0.36|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Week 12||0.36|-0.19|0.538
74098331|NCT00678886|147745022|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.12||||0.54|TWO_SIDED|95.0|-0.88|3.11|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Week 12||3.11|-0.88|0.540
74098332|NCT00678886|147745022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.83||||0.546|TWO_SIDED|95.0|-1.89|3.56|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 6||3.56|-1.89|0.546
74098333|NCT00678886|147745022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.462|TWO_SIDED|95.0|-1.56|3.42|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 12||3.42|-1.56|0.462
73881184|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.56||||0.0191|TWO_SIDED|95.0|1.23|10.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.28|1.23|0.0191
74098334|NCT00678886|147745023|SUPERIORITY_OR_OTHER|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6||||0.957
73881185|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|12.11||||0.0019|TWO_SIDED|95.0|2.52|58.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||58.22|2.52|0.0019
74098335|NCT00678886|147745023|SUPERIORITY_OR_OTHER|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12||||0.957
74098336|NCT00678886|147745024|SUPERIORITY_OR_OTHER|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6||||0.653
73881186|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0593|TWO_SIDED|95.0|0.96|7.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.90|0.96|0.0593
73881187|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|4.95||||0.0048|TWO_SIDED|95.0|1.63|15.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||15.04|1.63|0.0048
74098337|NCT00678886|147745024|SUPERIORITY_OR_OTHER|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12||||0.653
74098338|NCT00206323|147745030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0259|||||||t-test, 2 sided|||"Primary variable change of TTS/YGTSS at the BSL to Day 70. Changes of YGTSS compared using analysis of covariance with score at day 1 as a covariate. Groups compared for incidence of AE's and of AESI based on Fisher's Exact Test. All tests were two-sided at the 5% level of significance.~The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment)"||||0.0259
74098339|NCT01943994|147745031|SUPERIORITY||Odds Ratio (OR)|6.12||||0.003|TWO_SIDED|95.0|1.99|23.26|||Regression, Logistic|||||23.26|1.99|0.003
74098340|NCT00758680|147745053|SUPERIORITY_OR_OTHER||LS Mean Difference on Last Dosing Day|37.63||||0.015|TWO_SIDED|95.0|12.58|62.68|||Mixed Effect Model|||||62.68|12.58|0.015
74098341|NCT00758680|147745053|SUPERIORITY_OR_OTHER||LS Mean Difference on Last Dosing Day|92.3|||<|0.001|TWO_SIDED|95.0|67.56|117.04|||Mixed Effect Model|||||117.04|67.56|<0.001
74098342|NCT00319982|147745057|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value. p\<0.05 considered statistically significant.|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in E' Velocity comparing baseline and final study visits||||0.75
73881188|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0494|TWO_SIDED|95.0|1.0|7.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.57|1.00|0.0494
74049360|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|77.96|STANDARD_ERROR_OF_MEAN|199.85||0.699|TWO_SIDED|95.0|-330.7|486.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||486.63|-330.70|0.699
74049361|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-341.91|STANDARD_ERROR_OF_MEAN|204.65||0.106|TWO_SIDED|95.0|-760.45|76.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||76.64|-760.45|0.106
74049362|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-289.41|STANDARD_ERROR_OF_MEAN|211.69||0.182|TWO_SIDED|95.0|-722.17|143.35|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||143.35|-722.17|0.182
74049363|NCT00853112|147651859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-256.6|STANDARD_ERROR_OF_MEAN|224.88||0.263|TWO_SIDED|95.0|-716.26|203.06|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||203.06|-716.26|0.263
74049364|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-328.1|STANDARD_ERROR_OF_MEAN|385.78||0.401|TWO_SIDED|95.0|-1114.11|457.92|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||457.92|-1114.11|0.401
74049365|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-164.96|STANDARD_ERROR_OF_MEAN|370.54||0.659|TWO_SIDED|95.0|-920.05|590.12|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||590.12|-920.05|0.659
74049366|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-287.08|STANDARD_ERROR_OF_MEAN|372.6||0.447|TWO_SIDED|95.0|-1047.59|473.42|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||473.42|-1047.59|0.447
74049367|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-457.16|STANDARD_ERROR_OF_MEAN|374.26||0.231|TWO_SIDED|95.0|-1220.86|306.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||306.53|-1220.86|0.231
74049368|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-75.24|STANDARD_ERROR_OF_MEAN|384.2||0.846|TWO_SIDED|95.0|-858.19|707.71|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||707.71|-858.19|0.846
74049369|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-115.64|STANDARD_ERROR_OF_MEAN|357.2||0.748|TWO_SIDED|95.0|-844.24|612.96|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||612.96|-844.24|0.748
74049370|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.87|STANDARD_ERROR_OF_MEAN|342.91||0.993|TWO_SIDED|95.0|-702.41|696.67|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||696.67|-702.41|0.993
74049371|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|174.2|STANDARD_ERROR_OF_MEAN|342.93||0.615|TWO_SIDED|95.0|-526.41|874.81|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||874.81|-526.41|0.615
74049372|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-494.91|STANDARD_ERROR_OF_MEAN|344.72||0.161|TWO_SIDED|95.0|-1199.04|209.21|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||209.21|-1199.04|0.161
74049373|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-134.48|STANDARD_ERROR_OF_MEAN|355.5||0.708|TWO_SIDED|95.0|-859.74|590.77|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||590.77|-859.74|0.708
74049374|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|47.61|STANDARD_ERROR_OF_MEAN|365.43||0.897|TWO_SIDED|95.0|-697.56|792.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||792.79|-697.56|0.897
74049375|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|98.42|STANDARD_ERROR_OF_MEAN|350.87||0.781|TWO_SIDED|95.0|-617.15|813.99|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||813.99|-617.15|0.781
74049376|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-28.31|STANDARD_ERROR_OF_MEAN|355.47||0.937|TWO_SIDED|95.0|-753.46|696.83|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||696.83|-753.46|0.937
74049377|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-369.57|STANDARD_ERROR_OF_MEAN|353.25||0.304|TWO_SIDED|95.0|-1090.86|351.72|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||351.72|-1090.86|0.304
74098343|NCT00319982|147745058|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Fisher Exact|||Adverse Events||||0.99
74049378|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-185.64|STANDARD_ERROR_OF_MEAN|363.77||0.613|TWO_SIDED|95.0|-927.54|556.27|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||556.27|-927.54|0.613
74049379|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|265.51|STANDARD_ERROR_OF_MEAN|324.88||0.42|TWO_SIDED|95.0|-397.45|928.48|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||928.48|-397.45|0.420
74049380|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|240.17|STANDARD_ERROR_OF_MEAN|311.63||0.447|TWO_SIDED|95.0|-395.81|876.14|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||876.14|-395.81|0.447
74049381|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-176.74|STANDARD_ERROR_OF_MEAN|309.11||0.572|TWO_SIDED|95.0|-808.1|454.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||454.63|-808.10|0.572
74098344|NCT00319982|147745059|SUPERIORITY_OR_OTHER||||||>|0.06|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value. p\<0.05 considered statistically significant.|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||||||>0.06
74098345|NCT00319982|147745060|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in LV End-Diastolic Diameter z-score from baseline to final visit||||<0.001
74098346|NCT00319982|147745062|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Percentage adherent to study medication||||0.08
74098347|NCT00319982|147745063|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||||||0.15
73881189|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.15||||0.1887|TWO_SIDED|95.0|0.69|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.70|0.69|0.1887
73881190|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0717|TWO_SIDED|95.0|0.91|10.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.7|0.91|0.0717
74049382|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.96|STANDARD_ERROR_OF_MEAN|311.11||0.929|TWO_SIDED|95.0|-663.31|607.38|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||607.38|-663.31|0.929
74049383|NCT00853112|147651860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|29.58|STANDARD_ERROR_OF_MEAN|323.01||0.928|TWO_SIDED|95.0|-629.62|688.79|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||688.79|-629.62|0.928
74098348|NCT01094886|147745064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.5||0.008|TWO_SIDED|95.0|-0.05|0.34|||t-test, 2 sided|||||0.34|-0.05|.008
74098349|NCT01094886|147745065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|STANDARD_DEVIATION|-1.1||0.111|TWO_SIDED|95.0|-2.048|0.219|||t-test, 2 sided|||||0.219|-2.048|0.111
74098350|NCT01094886|147745066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|6.977||0.87|TWO_SIDED|95.0|-2.77|2.35|||t-test, 2 sided|||||2.35|-2.77|0.87
74098351|NCT01094886|147745067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.13|STANDARD_DEVIATION|36.316|<|0.001|TWO_SIDED|95.0|-48.01|-22.26|||t-test, 2 sided|||||-22.26|-48.01|<0.001
74098352|NCT00371397|147745148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.75||||0.009||95.0|||||Regression, Logistic|||hsCRP dichotomized as undetectable/detectable. Logistic regression w/generalized estimating equations(GEE)s to determine odds ratio. Assessed hsCRP at baseline at each of the three visits; 43% of the values (n = 65) were below the assay's detectable lower bound of .3 mg/dL, and thus hsCRP was dichotomized as undetectable/detectable.||||.009
74049384|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.412|TWO_SIDED|95.0|-0.35|0.83|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.83|-0.35|0.412
74049385|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.999|TWO_SIDED|95.0|-0.58|0.58|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.58|-0.58|0.999
74049386|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.28||0.535|TWO_SIDED|95.0|-0.39|0.74|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.74|-0.39|0.535
74049387|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.28||0.128|TWO_SIDED|95.0|-0.13|1.01|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.01|-0.13|0.128
74098353|NCT01284621|147745168|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|96.55|STANDARD_DEVIATION|7.1|||TWO_SIDED|90.0|93.05|100.18|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||100.18|93.05|
74098354|NCT01284621|147745169|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|104.47|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|97.65|111.77|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||111.77|97.65|
74098355|NCT01284621|147745170|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|108.14|STANDARD_DEVIATION|14.0|||TWO_SIDED|90.0|100.51|116.35|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||116.35|100.51|
73881191|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.43||||0.1419|TWO_SIDED|95.0|0.74|7.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.92|0.74|0.1419
74049388|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.29||0.823|TWO_SIDED|95.0|-0.67|0.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.53|-0.67|0.823
74049389|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.34||0.396|TWO_SIDED|95.0|-0.4|0.99|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.99|-0.40|0.396
74049390|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.33||0.899|TWO_SIDED|95.0|-0.63|0.72|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.72|-0.63|0.899
74049391|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.33||0.928|TWO_SIDED|95.0|-0.7|0.64|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.64|-0.70|0.928
74049392|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.33||0.203|TWO_SIDED|95.0|-0.25|1.11|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.11|-0.25|0.203
74049393|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.772|TWO_SIDED|95.0|-0.6|0.8|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.80|-0.60|0.772
74049394|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.29||0.771|TWO_SIDED|95.0|-0.52|0.69|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.69|-0.52|0.771
74098356|NCT01284621|147745171|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|103.61|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|89.73|119.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||119.64|89.73|
74098357|NCT01284621|147745172|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|98.67|STANDARD_DEVIATION|5.2|||TWO_SIDED|90.0|96.0|101.42|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||101.42|96.00|
74098358|NCT01284621|147745173|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|98.29|STANDARD_DEVIATION|11.3|||TWO_SIDED|90.0|92.67|104.25|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||104.25|92.67|
74098359|NCT02105974|147745269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034||||0.001|TWO_SIDED|95.0|0.014|0.055|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.055|0.014|0.001
73881192|NCT03192176|147297630|SUPERIORITY|0.0141|Odds Ratio (OR)|14.37||||0.0141|TWO_SIDED|95.0|1.71|120.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||120.6|1.71|0.0141
74049395|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.29||0.572|TWO_SIDED|95.0|-0.75|0.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.42|-0.75|0.572
74049396|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.29||0.966|TWO_SIDED|95.0|-0.58|0.6|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.60|-0.58|0.966
74049397|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.28||0.157|TWO_SIDED|95.0|-0.17|1.0|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.00|-0.17|0.157
74049398|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.3||0.546|TWO_SIDED|95.0|-0.43|0.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.79|-0.43|0.546
74049399|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.28||0.818|TWO_SIDED|95.0|-0.51|0.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.64|-0.51|0.818
74098360|NCT02105974|147745270|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.62||||0.084|TWO_SIDED|95.0|-0.35|5.59|||ANCOVA|||||5.59|-0.35|0.084
74098361|NCT02105974|147745271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.43|0.78||Nominal p-value|Regression, Cox|||||0.78|0.43|<0.001
74098362|NCT02585934|147745277|SUPERIORITY||least square mean difference|-0.36||||0.2249|TWO_SIDED|95.0|-0.95|0.22||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.22|-0.95|0.2249
74098363|NCT02585934|147745278|SUPERIORITY||least square mean difference|-0.09||||0.826|TWO_SIDED|95.0|-0.9|0.72||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.72|-0.90|0.8260
74049400|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.603|TWO_SIDED|95.0|-0.71|0.42|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.42|-0.71|0.603
74098364|NCT02585934|147745279|SUPERIORITY||least square mean difference|-0.12||||0.0234|TWO_SIDED|95.0|-0.22|-0.02||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||-0.02|-0.22|0.0234
74098365|NCT02585934|147745280|SUPERIORITY||least square mean difference|0.12||||0.2096|TWO_SIDED|95.0|-0.07|0.32||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.32|-0.07|0.2096
74098366|NCT02585934|147745281|SUPERIORITY||least square mean difference|-0.14||||0.765|TWO_SIDED|95.0|-1.09|0.8||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.80|-1.09|0.7650
74098367|NCT02585934|147745282|SUPERIORITY||least square mean difference|-0.38||||0.2472|TWO_SIDED|95.0|-1.03|0.27||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.27|-1.03|0.2472
74098368|NCT04314648|147745296|SUPERIORITY||Odds Ratio (OR)|6.26|||<|0.001|TWO_SIDED|95.0|2.38|16.48|||Regression, Logistic|||||16.48|2.38|<.001
74098369|NCT04314648|147745297|SUPERIORITY||Odds Ratio, log|5.76|||<|0.01|TWO_SIDED|95.0|1.86|17.86|||Regression, Logistic|||||17.86|1.86|<.01
73881193|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0775|TWO_SIDED|95.0|0.88|11.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.54|0.88|0.0775
74049401|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.27||0.495|TWO_SIDED|95.0|-0.37|0.74|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.74|-0.37|0.495
74049402|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.27||0.375|TWO_SIDED|95.0|-0.31|0.8|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.80|-0.31|0.375
74049403|NCT00853112|147651861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.29||0.392|TWO_SIDED|95.0|-0.34|0.84|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.84|-0.34|0.392
74049404|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|3.75||0.21|TWO_SIDED|95.0|-12.47|2.86|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.86|-12.47|0.210
74049405|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.47|STANDARD_ERROR_OF_MEAN|3.61||0.225|TWO_SIDED|95.0|-11.84|2.9|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.90|-11.84|0.225
74049406|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|3.73||0.332|TWO_SIDED|95.0|-11.28|3.93|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.93|-11.28|0.332
74049407|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|3.76||0.714|TWO_SIDED|95.0|-9.06|6.28|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||6.28|-9.06|0.714
74049408|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.01|STANDARD_ERROR_OF_MEAN|3.73||0.04|TWO_SIDED|95.0|-15.63|-0.39|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-0.39|-15.63|0.040
74049409|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.14|STANDARD_ERROR_OF_MEAN|3.37||0.079|TWO_SIDED|95.0|-13.02|0.75|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.75|-13.02|0.079
74049410|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|3.24||0.573|TWO_SIDED|95.0|-8.46|4.77|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||4.77|-8.46|0.573
74049411|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|3.34||0.28|TWO_SIDED|95.0|-10.5|3.15|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.15|-10.50|0.280
74049412|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|3.38||0.684|TWO_SIDED|95.0|-8.28|5.51|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||5.51|-8.28|0.684
74049413|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.17|STANDARD_ERROR_OF_MEAN|3.35||0.021|TWO_SIDED|95.0|-15.01|-1.34|||Longitudinal analysis|||mPAP at Hour 2: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.||-1.34|-15.01|0.021
74049414|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|3.7||0.727|TWO_SIDED|95.0|-8.86|6.25|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||6.25|-8.86|0.727
74049415|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|3.56||0.183|TWO_SIDED|95.0|-12.12|2.42|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.42|-12.12|0.183
74049416|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.01|STANDARD_ERROR_OF_MEAN|3.67||0.112|TWO_SIDED|95.0|-13.51|1.49|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.49|-13.51|0.112
74049417|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|3.71||0.928|TWO_SIDED|95.0|-7.91|7.23|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||7.23|-7.91|0.928
74049418|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.01|STANDARD_ERROR_OF_MEAN|3.68||0.02|TWO_SIDED|95.0|-16.52|-1.5|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-1.50|-16.52|0.020
74049419|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|3.79||0.136|TWO_SIDED|95.0|-13.55|1.94|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.94|-13.55|0.136
74049420|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.82|STANDARD_ERROR_OF_MEAN|3.65||0.303|TWO_SIDED|95.0|-11.27|3.63|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.63|-11.27|0.303
74049421|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.17|STANDARD_ERROR_OF_MEAN|3.77||0.18|TWO_SIDED|95.0|-12.87|2.52|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.52|-12.87|0.180
74049422|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.56|STANDARD_ERROR_OF_MEAN|3.8||0.506|TWO_SIDED|95.0|-10.31|5.2|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||5.20|-10.31|0.506
74049423|NCT00853112|147651862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.84|STANDARD_ERROR_OF_MEAN|3.77||0.026|TWO_SIDED|95.0|-16.54|-1.14|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-1.14|-16.54|0.026
73881194|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|4.35||||0.0283|TWO_SIDED|95.0|1.17|16.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.19|1.17|0.0283
74049424|NCT02477800|147651875|SUPERIORITY||Difference from Placebo|0.11||||0.225|TWO_SIDED|95.0|-0.469|0.403|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.403|-0.469|0.2250
74098370|NCT04314648|147745298|SUPERIORITY||Odds Ratio (OR)|0.74||||0.64|TWO_SIDED|95.0|0.21|2.64|||Regression, Logistic||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a logistic regression model, adjusted for baseline use.|||2.64|.21|.64
74098371|NCT04314648|147745299|SUPERIORITY||Odds Ratio (OR)|2.67||||0.35|TWO_SIDED|95.0|0.35|20.51|||Regression, Logistic||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a logistic regression model, adjusted for baseline use.|||20.51|.35|.35
74098372|NCT04314648|147745300|SUPERIORITY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|2.32||0.43|TWO_SIDED||||||Regression, Linear||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a linear regression model, adjusted for baseline use.|||||.43
74098373|NCT04314648|147745301|SUPERIORITY||Mean Difference (Net)|2.35|STANDARD_ERROR_OF_MEAN|3.0||0.44|TWO_SIDED||||||Regression, Linear||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a liner regression model, adjusted for baseline use.|||||.44
74098374|NCT04314648|147745302|SUPERIORITY||Odds Ratio (OR)|1.19||||0.77|TWO_SIDED|95.0|0.39|3.62|||Regression, Logistic|||||3.62|.39|.77
74098375|NCT00492024|147745306|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value is adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|Adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo||||0.189
74098376|NCT00492024|147745311|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||p-value adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo||||0.075
74098377|NCT04623086|147745343|OTHER|Comparison of two groups|Mean Difference (Net)|8.1||||0.14|TWO_SIDED||||||t-test, 2 sided|||For our power calculations, we assumed the true change in TIR to be 0% for the bridging group and 15% for the direct-conversion group, and we assumed a common standard deviation of 15% (meaning the distributions of change in TIR are separated by 1 standard-deviation unit), and thereby obtained that 20 patients in each group would provide 87% power to observe a statistically significant (at the two-sided level of .05) difference in mean change of TIR.||||0.14
74098378|NCT04623086|147745344|OTHER|Comparison of two groups|Mean Difference (Net)|4.1||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
74098379|NCT04623086|147745345|OTHER|Comparison of two groups|Mean Difference (Net)|12.1||||0.29|TWO_SIDED||||||t-test, 2 sided|||||||0.29
74098380|NCT04623086|147745346|OTHER|Comparison of two groups|Mean Difference (Net)|-11.9||||0.015|TWO_SIDED||||||t-test, 2 sided|||||||0.015
74098381|NCT04623086|147745347|OTHER||Mean Difference (Net)|0.3||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
74098382|NCT04623086|147745348|OTHER|Comparison of two groups|Mean Difference (Net)|2.6||||0.031|TWO_SIDED||||||t-test, 2 sided|||||||0.031
74098383|NCT04623086|147745349|OTHER|Comparison of two groups|Mean Difference (Net)|1.1||||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.27
74098384|NCT04623086|147745350|OTHER|Comparison of two groups|Mean Difference (Net)|0.0|||>|0.99|TWO_SIDED||||||t-test, 2 sided|||||||>0.99
74098385|NCT01798316|147745382|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
74098386|NCT03201965|147745403|SUPERIORITY||Odds Ratio (OR)|5.13|||<|0.0001|TWO_SIDED|95.0|3.22|8.16|||Cochran-Mantel-Haenszel|||||8.16|3.22|<0.0001
74098387|NCT01330420|147745433|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.001
74098388|NCT01330420|147745434|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.001
74098389|NCT01330420|147745435|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.01
74098390|NCT01330420|147745437|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.01
74098391|NCT03322930|147745438|OTHER||||||<|0.05||||||calculated from data|t-test, 2 sided||||mean sensitivity for group; Coefficient of Repeatability for multiple tests per patient|||<0.05
74098392|NCT01687244|147745439|SUPERIORITY_OR_OTHER||HGRF survival at 12 months|33.3|||||TWO_SIDED|90.0|16.8|53.6||Not applicable: the primary analysis was a calculation of a confidence interval||||The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion||53.6|16.8|
74098393|NCT01687244|147745439|SUPERIORITY_OR_OTHER||HGRF survival at 12 months|36.8|||||TWO_SIDED|90.0|18.8|58.2|||||The proportion of subjects achieving high-grade recurrence-free survival at 12 months|The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion.||58.2|18.8|
74098394|NCT02373189|147745452|SUPERIORITY|||||||0.05||||||The P-value indicated above is calculated.|paired t-test|means at pre and post treatment were compared within subject.||||||0.05
74098395|NCT02373189|147745453|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
74098396|NCT01758588|147745465|OTHER||||||||||||||||||A statistical comparison and analysis of the clinical improvement (CI) proportions cannot be made because the sample size (n=5 in treatment arm, n=3 in observation arm) is too small|||
74098397|NCT02151877|147745468|OTHER||||||>|0.05||||||This test applies to the first marker, cardiac troponin I.|t-test, 2 sided|||Null: mean cardiac troponin I changes in the NO group = mean cardiac troponin I changes in the control||||>0.05
74098398|NCT02151877|147745469|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Null: NO group fluid balances are the same as the control||||>0.05
74098399|NCT03185013|147745474|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in percentage|11.4||||0.029|TWO_SIDED|95.0|-0.4|21.2|||Miettinen and Nurminen method|||||21.2|-0.4|0.029
74098400|NCT03185013|147745476|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|12.8|||||TWO_SIDED|95.0|-0.6|24.5||||||||24.5|-0.6|
74098401|NCT03185013|147745477|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|18.2|||||TWO_SIDED|95.0|5.1|29.4||||||||29.4|5.1|
74098402|NCT03185013|147745478|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|13.5|||||TWO_SIDED|95.0|1.7|23.5||||||||23.5|1.7|
74098403|NCT03185013|147745479|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|11.8|||||TWO_SIDED|95.0|1.5|20.3||||||||20.3|1.5|
74098404|NCT03185013|147745480|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|-1.7|||||TWO_SIDED|95.0|-11.5|10.3||||||||10.3|-11.5|
74098405|NCT03185013|147745481|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|10.8|||||TWO_SIDED|95.0|-0.5|20.1||||||||20.1|-0.5|
74098406|NCT03185013|147745482|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|224.0|||||TWO_SIDED|95.0|24.0|224.0||||||Week 15: HPV-16 E7||224.0|24.0|
74098407|NCT03185013|147745482|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 36: HPV-16 E7||0.0|0.0|
74098408|NCT03185013|147745482|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location Shift|2024.0|||||TWO_SIDED|95.0|2000.0|6050.0||||||Week 15: HPV-18 E7||6050.0|2000.0|
74098409|NCT03185013|147745482|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location Shift|224.0|||||TWO_SIDED|95.0|74.0|674.0||||||Week 36: HPV-18 E7||674.0|74.0|
74098410|NCT03185013|147745483|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|11.67|||||TWO_SIDED|95.0|8.33|20.0||||||HPV-16 E6: Week 15||20.00|8.33|
74098411|NCT03185013|147745483|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|8.33|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 36||11.67|3.33|
73881195|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1767|TWO_SIDED|95.0|0.7|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.96|0.70|0.1767
74098412|NCT03185013|147745483|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|10.83|||||TWO_SIDED|95.0|5.0|15.0||||||HPV-16 E7: Week 15||15.00|5.00|
74098413|NCT03185013|147745483|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|7.5|||||TWO_SIDED|95.0|1.67|10.0||||||HPV-16 E7: Week 36||10.00|1.67|
74098414|NCT03185013|147745483|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|50.83|||||TWO_SIDED|95.0|31.67|66.67||||||HPV-18 E6: Week 15||66.67|31.67|
74098415|NCT03185013|147745483|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|38.33|||||TWO_SIDED|95.0|18.33|51.67||||||HPV-18 E6: Week 36||51.67|18.33|
74098416|NCT03185013|147745483|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|14.17|||||TWO_SIDED|95.0|6.67|18.33||||||HPV-18 E7: Week 15||18.33|6.67|
74098417|NCT03185013|147745483|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|10.0|||||TWO_SIDED|95.0|5.0|15.0||||||HPV-18 E7: Week 36||15.00|5.00|
74098418|NCT03185013|147745484|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.025|||||TWO_SIDED|95.0|0.002|0.046||||||Parameter: CD8+CD137+Perforin+||0.046|0.002|
74098419|NCT03185013|147745484|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.011|||||TWO_SIDED|95.0|0.0|0.014||||||Parameter: CD8+CD38+Perforin+||0.014|0.000|
74098420|NCT03185013|147745484|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.044|||||TWO_SIDED|95.0|0.017|0.058||||||Parameter: CD8+CD69+Perforin+||0.058|0.017|
74098421|NCT00673387|147745521|SUPERIORITY_OR_OTHER||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||<0.0001
74098422|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.0002||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.0002
74049425|NCT02477800|147651875|SUPERIORITY||Difference from late start group|0.03||||0.833|TWO_SIDED|95.0|-0.262|0.326|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.326|-0.262|0.8330
74049426|NCT02477800|147651876|SUPERIORITY||Difference from Placebo|0.2||||0.4795|TWO_SIDED|95.0|-0.35|0.74|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.74|-0.35|0.4795
74049427|NCT02477800|147651876|SUPERIORITY||Difference from Placebo|-0.1||||0.8106|TWO_SIDED|95.0|-0.62|0.49|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.49|-0.62|0.8106
74049428|NCT02477800|147651877|SUPERIORITY||Difference from Placebo|-0.583||||0.2536|TWO_SIDED|95.0|-1.5835|0.4181|||MMRM Model|||Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.||0.4181|-1.5835|0.2536
74049429|NCT02477800|147651877|SUPERIORITY||Difference from Placebo|-0.588||||0.2578|TWO_SIDED|95.0|-1.6067|0.4309|||MMRM Model|||Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.||0.4309|-1.6067|0.2578
74049430|NCT02477800|147651878|SUPERIORITY||Difference from Placebo|0.7||||0.1225|TWO_SIDED|95.0|-0.19|1.64|||MMRM Model|||Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.||1.64|-0.19|0.1225
74049431|NCT02477800|147651878|SUPERIORITY||Difference from late start group|0.7||||0.1506|TWO_SIDED|95.0|-0.25|1.61|||MMRM Model|||Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.||1.61|-0.25|0.1506
74049432|NCT00958191|147651886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 1 year||||<0.0001
74049433|NCT00958191|147651886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 3 years||||<0.0001
74049434|NCT00958191|147651886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in HHS from pre-op to 5 years||||<0.0001
74049435|NCT00958191|147651887|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 1 year||||<0.0001
74098423|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.0004||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.0004
74098424|NCT00673387|147745521|SUPERIORITY_OR_OTHER||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||||||<0.0001
74098425|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||||||0.0001
74049436|NCT00958191|147651887|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 3 years||||<0.0001
74049437|NCT00958191|147651887|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 5 years||||<0.0001
74049438|NCT00958191|147651888|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 1 year||||<0.0001
74098426|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.251||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2510
73881196|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.2||||0.1675|TWO_SIDED|95.0|0.72|6.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.72|0.72|0.1675
73881197|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.84||||0.2717|TWO_SIDED|95.0|0.62|5.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.49|0.62|0.2717
73881198|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1367|TWO_SIDED|95.0|0.76|7.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.64|0.76|0.1367
74049439|NCT00958191|147651888|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 3 years||||<0.0001
74049440|NCT00958191|147651888|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 5 years||||<0.0001
74049441|NCT00958191|147651889|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 1 year||||<0.0001
74049442|NCT00958191|147651889|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in SF-12 Phyiscal Component Score from preop to 3 year||||<0.0001
74049443|NCT00958191|147651889|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 5 year||||<0.0001
74049444|NCT00958191|147651889|SUPERIORITY_OR_OTHER|||||||0.0242|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 1 year||||0.0242
74049445|NCT00958191|147651889|SUPERIORITY_OR_OTHER|||||||0.0247|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 3 year||||0.0247
74049446|NCT00958191|147651889|SUPERIORITY_OR_OTHER|||||||0.1372|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 5 year||||0.1372
74049447|NCT00958191|147651890|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 1 year||||<0.0001
74049448|NCT00958191|147651890|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 3 year||||<0.0001
74049449|NCT00958191|147651890|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in LEAS Score from preop to 5 year||||<0.0001
74049450|NCT00415623|147651913|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7|||<|0.001||95.0|-9.0|-4.4|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-4.4|-9.0|<0.001
74049451|NCT00415623|147651914|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|||<|0.001||95.0|-5.7|-2.5|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-2.5|-5.7|<0.001
74098427|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.3433||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3433
74098428|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.4503||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.4503
74098429|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.2122||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2122
73881199|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|13.53||||0.0162|TWO_SIDED|95.0|1.62|113.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||113.0|1.62|0.0162
74049452|NCT00415623|147651915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|||<|0.001||95.0|-9.1|-5.1|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-5.1|-9.1|<0.001
74049453|NCT00415623|147651916|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||<|0.001||95.0|-5.4|-2.6|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-2.6|-5.4|<0.001
74049454|NCT00415623|147651917|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.002||95.0|1.36|3.99|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||3.99|1.36|0.002
74049455|NCT00415623|147651918|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.46|||<|0.001||95.0|2.28|8.74|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||8.74|2.28|<0.001
74049456|NCT00415623|147651919|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55||||0.001||95.0|1.5|4.36|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||4.36|1.50|0.001
74049457|NCT00415623|147651920|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.16|||<|0.001||95.0|2.12|8.19|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||8.19|2.12|<0.001
74049458|NCT01855867|147651924|SUPERIORITY|Statistical significance was determined at the alpha 0.05 level. The study regimen completion rates of participants in the current study taking a fixed dose once daily combination of elvitegravir/cobicistat/TDF/FTC were compared to historical controls who used PEP regimens consisting of TDF/FTC daily and raltegravir twice daily, or earlier regimens of twice daily zidovudine (AZT)/lamivudine (3TC) and a protease inhibitor, using chi-square tests for independence.|chi square||||<|0.05||||||Reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|Chi-squared|||using historical controls||||<0.05
74049459|NCT00678249|147651926|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
74049460|NCT01708915|147651935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.362|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.699|-1.025||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-1.025|-1.699|<0.0001
74049461|NCT01708915|147651935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.983|STANDARD_ERROR_OF_MEAN|0.173|<|0.0001|TWO_SIDED|95.0|-1.324|-0.642||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.642|-1.324|<0.0001
74049462|NCT01708915|147651935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.195||0.4171||95.0|-0.541|0.225||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||0.225|-0.541|0.4171
74049463|NCT01708915|147651936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.049|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-1.305|-0.793||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.793|-1.305|<0.0001
74049464|NCT01708915|147651936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.731|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001||95.0|-1.003|-0.459||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.459|-1.003|<0.0001
74049465|NCT01708915|147651936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.152||0.7037||95.0|-0.356|0.241||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||0.241|-0.356|0.7037
74049466|NCT01708915|147651937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.655|STANDARD_ERROR_OF_MEAN|0.208|<|0.0001||95.0|-2.064|-1.247|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-1.247|-2.064|<0.0001
74049467|NCT01708915|147651937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.169|STANDARD_ERROR_OF_MEAN|0.209|<|0.0001||95.0|-1.578|-0.759|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-0.759|-1.578|<0.0001
74049468|NCT01708915|147651937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.466|STANDARD_ERROR_OF_MEAN|0.209||0.0259||95.0|-0.875|-0.056|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-0.056|-0.875|0.0259
74049469|NCT01708915|147651938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.385|||<|0.0001||95.0|4.943|11.032|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Placebo. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||11.032|4.943|<0.0001
74049470|NCT01708915|147651938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.62|||<|0.0001||95.0|2.469|5.308|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nicoboxil. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||5.308|2.469|<0.0001
74049471|NCT01708915|147651938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.594||||0.0129||95.0|1.104|2.303|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nonivamide. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||2.303|1.104|0.0129
74049472|NCT01601873|147651944|SUPERIORITY|||||||0.884|||||||Wilcoxon (Mann-Whitney)|||||||0.884
74049473|NCT01601873|147651945|SUPERIORITY|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
74049474|NCT01601873|147651946|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||||||0.294
74049475|NCT01601873|147651947|SUPERIORITY|||||||0.538|||||||Log Rank|||||||0.538
74049476|NCT01601873|147651948|SUPERIORITY|||||||0.786|||||||Log Rank|||||||0.786
74098430|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.2232||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2232
74098431|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.4207||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.4207
74049477|NCT01601873|147651949|SUPERIORITY|||||||0.185|||||||Log Rank|||||||0.185
74049478|NCT02096471|147651959|SUPERIORITY|Single group study. Change in Pain from Baseline amongst those with a tumor response|Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|0.84||0.11|TWO_SIDED||||||t-test, 2 sided|Descriptive analysis only||Single group change from baseline||||0.11
74049479|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|0.8||0.01|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.01
74049480|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.66||0.18|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.18
74049481|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life (QOL) from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.77|STANDARD_ERROR_OF_MEAN|3.6||0.3|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.30
74049482|NCT02096471|147651959|SUPERIORITY|Single Group Study Change in Quality of Life from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|6.87||0.61|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.61
74049483|NCT02096471|147651959|SUPERIORITY|Single Group Study Change in Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-13.06|STANDARD_ERROR_OF_MEAN|8.29||0.12|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.12
74049484|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-12.98|STANDARD_ERROR_OF_MEAN|6.35||0.05|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only.||Single Group Change from Baseline||||0.05
74049485|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|6.66|STANDARD_ERROR_OF_MEAN|5.05||0.19|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.19
74049486|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|6.46||0.72|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.72
74049487|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|6.74||0.36|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.36
74049488|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|6.37||0.98|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.98
74049489|NCT02096471|147651959|SUPERIORITY|Single Group Study. change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|7.99||0.93|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.93
74049490|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-10.97|STANDARD_ERROR_OF_MEAN|8.16||0.19|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.19
74098432|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.5375||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%||||0.5375
74098433|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.6633||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%||||0.6633
74098434|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.3667||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3667
74098435|NCT00673387|147745521|SUPERIORITY_OR_OTHER|||||||0.372||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3720
74098436|NCT00673387|147745525|SUPERIORITY_OR_OTHER|||||||0.0404|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate||||0.0404
74049491|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|6.58||0.57|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.57
74049492|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|5.51||0.45|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.45
74049493|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.27|STANDARD_ERROR_OF_MEAN|5.72||0.28|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.28
74049494|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|8.52||0.93|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.93
74049495|NCT02096471|147651959|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|7.53||0.89|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.89
74049496|NCT02449915|147651962|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
74098437|NCT00673387|147745525|SUPERIORITY_OR_OTHER|||||||0.0265|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0265
74098438|NCT00673387|147745525|SUPERIORITY_OR_OTHER|||||||0.1357|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.1357
74098439|NCT00673387|147745525|SUPERIORITY_OR_OTHER|||||||0.0409|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0409
74098440|NCT00673387|147745525|SUPERIORITY_OR_OTHER|||||||0.0082|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0082
74049497|NCT04223778|147651980|NON_INFERIORITY|Doravirine/Islatravir (DOR/ISL) - Baseline Antiretroviral Therapy (ART). Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 4 percentage points.|Estimated Difference|-1.49|||<|0.001|TWO_SIDED|95.0|-3.44|-0.34|||Miettinen and Nurminen|The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.||||-0.34|-3.44|<.001
74049498|NCT04223778|147651981|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|9.8|||||TWO_SIDED|95.0|3.3|16.3|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||16.3|3.3|
74049499|NCT04223778|147651982|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.8|||||TWO_SIDED|95.0|0.2|4.0|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||4.0|0.2|
74049500|NCT04223778|147651983|OTHER|Doravirine/Islatravir (DOR/ISL)- Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.3|||||TWO_SIDED|95.0|-3.28|3.9|||||The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.|HIV-1 RNA \<40 copies/mL||3.90|-3.28|
74049501|NCT04223778|147651983|OTHER|Doravirine/Islatravir (DOR/ISL)- Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.89|||||TWO_SIDED|95.0|-2.58|4.43|||||The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.|HIV-1 RNA \<50 copies/mL||4.43|-2.58|
74098441|NCT00673387|147745529|SUPERIORITY_OR_OTHER|||||||0.0464|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0464
74098442|NCT00673387|147745529|SUPERIORITY_OR_OTHER|||||||0.0647|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0647
74098443|NCT00673387|147745529|SUPERIORITY_OR_OTHER|||||||0.069|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0690
74098444|NCT00673387|147745529|SUPERIORITY_OR_OTHER|||||||0.3717|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.3717
74098445|NCT00673387|147745529|SUPERIORITY_OR_OTHER|||||||0.0327|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0327
74098446|NCT00673387|147745530|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0049
73881200|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.23||||0.0765|TWO_SIDED|95.0|0.88|11.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.78|0.88|0.0765
74098447|NCT00673387|147745530|SUPERIORITY_OR_OTHER|||||||0.0047|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0047
74098448|NCT00673387|147745530|SUPERIORITY_OR_OTHER|||||||0.0046|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0046
74098449|NCT00673387|147745530|SUPERIORITY_OR_OTHER|||||||0.0257|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0257
74098450|NCT00673387|147745530|SUPERIORITY_OR_OTHER|||||||0.0014|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0014
74098451|NCT00673387|147745531|SUPERIORITY_OR_OTHER|||||||0.0222|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0222
74098452|NCT00673387|147745531|SUPERIORITY_OR_OTHER|||||||0.0128|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0128
74098453|NCT00673387|147745531|SUPERIORITY_OR_OTHER|||||||0.0122|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0122
74098454|NCT00673387|147745531|SUPERIORITY_OR_OTHER|||||||0.0073|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0073
74098455|NCT00673387|147745531|SUPERIORITY_OR_OTHER|||||||0.0034|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0034
74098456|NCT00960115|147745549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.828|TWO_SIDED|95.0|0.614|1.479||This trial was not powered to demonstrate statistical significance of treatment differences with respect to a statistical test, i.e., the p value being lower than a significance level of alpha (α) = 0.05.|Log Rank||Cox proportional hazards regression model|||1.479|0.614|0.828
74098457|NCT01197755|147745565|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.17||||0.004|TWO_SIDED|95.0|0.05|0.28||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.28|0.05|0.004
74098458|NCT01197755|147745565|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.07||||0.168|TWO_SIDED|95.0|-0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|-0.03|0.168
74098459|NCT01197755|147745566|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.22|||<|0.001|TWO_SIDED|95.0|0.16|0.29|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.29|0.16|<0.001
74098460|NCT01197755|147745567|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.1||||0.014|TWO_SIDED|95.0|0.02|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.19|0.02|0.014
74049502|NCT04223778|147651986|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-8.9|||||TWO_SIDED|95.0|-13.4|-4.5|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||-4.5|-13.4|
74049503|NCT04223778|147651991|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-19.75|||||TWO_SIDED|95.0|-33.07|-6.44|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Cholesterol||-6.44|-33.07|
74049504|NCT04223778|147651991|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-1.35|||||TWO_SIDED|95.0|-6.55|3.84|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting HDL Cholesterol||3.84|-6.55|
74049505|NCT04223778|147651991|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-13.94|||||TWO_SIDED|95.0|-24.69|-3.2|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting LDL Cholesterol||-3.20|-24.69|
74049506|NCT04223778|147651991|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-17.74|||||TWO_SIDED|95.0|-30.02|-5.46|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Non-HDL Cholesterol||-5.46|-30.02|
74049507|NCT04223778|147651991|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-21.28|||||TWO_SIDED|95.0|-45.51|2.96|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Triglycerides||2.96|-45.51|
74049508|NCT04223778|147651992|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-4.17|||||TWO_SIDED|95.0|-10.43|2.09|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||2.09|-10.43|
74049509|NCT04223778|147651992|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.81|||||TWO_SIDED|95.0|-1.46|3.09|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||3.09|-1.46|
74098461|NCT01197755|147745567|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.05||||0.18|TWO_SIDED|95.0|-0.02|0.12||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|-0.02|0.180
74098462|NCT01197755|147745568|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.12|||<|0.001|TWO_SIDED|95.0|0.06|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.19|0.06|<0.001
74049510|NCT04223778|147651992|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-3.87|||||TWO_SIDED|95.0|-9.47|1.74|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||1.74|-9.47|
74049511|NCT04223778|147651992|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-4.92|||||TWO_SIDED|95.0|-11.21|1.38|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||1.38|-11.21|
74049512|NCT04223778|147651992|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.65|||||TWO_SIDED|95.0|-16.14|19.43|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||19.43|-16.14|
74049513|NCT04223778|147651993|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.05|||||TWO_SIDED|95.0|-7.6|9.7|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||9.70|-7.60|
74049514|NCT04223778|147651993|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-3.16|||||TWO_SIDED|95.0|-6.37|0.05|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||0.05|-6.37|
74049515|NCT04223778|147651993|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|4.38|||||TWO_SIDED|95.0|-2.27|11.03|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||11.03|-2.27|
74049516|NCT04223778|147651993|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|3.63|||||TWO_SIDED|95.0|-3.93|11.19|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||11.19|-3.93|
74049517|NCT04223778|147651993|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-1.79|||||TWO_SIDED|95.0|-15.89|12.31|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||12.31|-15.89|
74049518|NCT04223778|147651994|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-18.41|||||TWO_SIDED|95.0|-32.05|-4.76|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||-4.76|-32.05|
74049519|NCT04223778|147651994|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.01|||||TWO_SIDED|95.0|-5.06|5.08|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||5.08|-5.06|
74049520|NCT04223778|147651994|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-14.12|||||TWO_SIDED|95.0|-25.81|-2.43|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||-2.43|-25.81|
74049521|NCT04223778|147651994|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-18.23|||||TWO_SIDED|95.0|-30.45|-6.0|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||-6.00|-30.45|
74049522|NCT04223778|147651994|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-27.79|||||TWO_SIDED|95.0|-51.08|-4.49|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||-4.49|-51.08|
74098463|NCT01197755|147745568|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.0||||0.891|TWO_SIDED|95.0|-0.04|0.04||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.04|-0.04|0.891
74098464|NCT01197755|147745569|SUPERIORITY_OR_OTHER||Treatment difference|||||0.01||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.010
74098465|NCT01197755|147745569|SUPERIORITY_OR_OTHER|||||||0.019||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.019
74098466|NCT01197755|147745570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.023|TWO_SIDED|95.0|1.21|13.91|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||13.91|1.21|0.023
74098467|NCT01197755|147745570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.197|TWO_SIDED|95.0|0.65|8.23||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.23|0.65|0.197
74098468|NCT01197755|147745571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.005|TWO_SIDED|95.0|1.54|10.92|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||10.92|1.54|0.005
74098469|NCT01197755|147745571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7||||0.002|TWO_SIDED|95.0|1.79|12.3||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||12.30|1.79|0.002
74098470|NCT01197755|147745572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.86|5.76||Nominal p value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data||5.76|1.86|<0.001
74098471|NCT01197755|147745572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.028|TWO_SIDED|95.0|1.07|3.31||Nominal p-value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data||3.31|1.07|0.028
74098472|NCT01197755|147745573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.004|TWO_SIDED|95.0|1.33|4.45|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||4.45|1.33|0.004
74049523|NCT04223778|147651994|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-14.12||||0.0094|TWO_SIDED|95.0|-27.56|-0.68||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting LDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|-0.68|-27.56|0.0094
74049524|NCT04223778|147651994|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-18.23||||0.0021|TWO_SIDED|95.0|-32.28|-4.17||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting Non-HDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|-4.17|-32.28|0.0021
74049525|NCT04223778|147651995|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-0.04|||||TWO_SIDED|95.0|-6.26|6.18|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||6.18|-6.26|
74098473|NCT01197755|147745573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.186|TWO_SIDED|95.0|0.82|2.79||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.79|0.82|0.186
74098474|NCT01197755|147745574|SUPERIORITY_OR_OTHER|||||||0.729||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.||||||0.729
74098475|NCT01197755|147745574|SUPERIORITY_OR_OTHER|||||||0.019||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.||||||0.019
74098476|NCT01197755|147745575|SUPERIORITY_OR_OTHER||Treatment difference|2.6||||0.009||95.0|0.65|4.56|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||4.56|0.65|0.009
74098477|NCT01197755|147745575|SUPERIORITY_OR_OTHER||Treatment difference|1.53||||0.118|TWO_SIDED|95.0|-0.39|3.44|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.44|-0.39|0.118
74098478|NCT01197755|147745576|SUPERIORITY_OR_OTHER||Treatment difference|0.67||||0.487||95.0|-1.23|2.58|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.58|-1.23|0.487
74098479|NCT01197755|147745576|SUPERIORITY_OR_OTHER||Treatment difference|0.62||||0.516|TWO_SIDED|95.0|-1.26|2.51|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.51|-1.26|0.516
74049526|NCT04223778|147651995|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.35|||||TWO_SIDED|95.0|-1.84|2.54|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||2.54|-1.84|
74049527|NCT04223778|147651995|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.64|||||TWO_SIDED|95.0|-4.83|6.11|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||6.11|-4.83|
74049528|NCT04223778|147651995|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-0.49|||||TWO_SIDED|95.0|-6.81|5.83|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||5.83|-6.81|
74098480|NCT01282723|147745592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0093|TWO_SIDED|95.0|1.1|1.95|||Mixed Models Analysis|||"Estimation of Odds Ratio of True Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the True Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly greater than TOCO.~Alternative hypothesis: There is a difference between the True Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly greater than SureCALL®."||1.95|1.10|0.0093
74049529|NCT04223778|147651995|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-5.45|||||TWO_SIDED|95.0|-20.46|9.57|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||9.57|-20.46|
74049530|NCT04223778|147651995|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|0.64||||0.4093|TWO_SIDED|95.0|-5.63|6.9||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting LDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|6.90|-5.63|0.4093
74049531|NCT04223778|147651995|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-0.49||||0.4397|TWO_SIDED|95.0|-7.72|6.75||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting Non-HDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|6.75|-7.72|0.4397
74049532|NCT04223778|147651996|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|2.31|||||TWO_SIDED|95.0|-5.54|10.17|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||10.17|-5.54|
74049533|NCT04223778|147651996|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-2.52|||||TWO_SIDED|95.0|-5.69|0.65|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||0.65|-5.69|
74049534|NCT04223778|147651996|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|2.34|||||TWO_SIDED|95.0|-3.73|8.42|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||8.42|-3.73|
74049535|NCT04223778|147651996|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|3.97|||||TWO_SIDED|95.0|-2.63|10.56|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||10.56|-2.63|
74049536|NCT04223778|147651996|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|10.5|||||TWO_SIDED|95.0|-3.97|24.96|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||24.96|-3.97|
74049537|NCT04223778|147651997|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.44|||||TWO_SIDED|95.0|-0.59|1.46|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|||1.46|-0.59|
74098481|NCT01282723|147745592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.3204|TWO_SIDED|95.0|0.61|1.17|||Mixed Models Analysis|||"Estimation of Odds Ratio of False Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the False Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly less than TOCO.~Alternative hypothesis: There is a difference between the False Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly less than SureCALL®."||1.17|0.61|0.3204
74049538|NCT00740116|147652005|SUPERIORITY|||||||0.03||||||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||||0.03
74049539|NCT00740116|147652006|SUPERIORITY|||||||0.07||||||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||||0.07
74049540|NCT00740116|147652007|SUPERIORITY||Odds Ratio (OR)|0.44||||0.46|ONE_SIDED|95.0||0.97||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||0.97||0.46
74049541|NCT00740116|147652008|SUPERIORITY|||||||0.46||||||p\< 0.05 for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.46
74049542|NCT00740116|147652009|SUPERIORITY||Odds Ratio (OR)|0.36||||0.22|TWO_SIDED|95.0|0.05|2.72||Statistical significance threshold p-value \< 0.05|Fisher Exact|||||2.72|0.05|0.22
74049543|NCT00121485|147652023|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|200 patients (137 HMII and 67 XVE) provides 80% power (alpha= 0.05 (one-sided)) using a Blackwelder like analysis and a non-inferiority margin of 10%. The protocol specifies that once non-inferiority is proven, the data will be analyzed for superiority using closed testing methods.|Mean Difference (Final Values)|35.7||||2.5e-07|TWO_SIDED|95.0|24.5|46.9||Two (2) interim analysis were pre-specified in the protocol. The type I error rate was preserved at 5% by use of the O'Brien-Fleming spending function.|Fisher Exact|||Primary endpoint is 2-yr survival free of stroke or re-operation to repair/replace the device. Patients are a success if composite endpoint achieved. Patients urgently transplanted due to device failure are failures. Patients electively transplanted after reversal of co-morbidity will be considered success if they achieve 2 years of survival from day of VAD implant and no stroke. HMII is a success if the proportion of HMII pts achieving the composite endpoint is equal to or better than HM XVE||46.9|24.5|0.00000025
74049544|NCT01111331|147652038|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean ratio|100.89|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|96.86|105.1|||ANOVA|Based on ANOVA with terms for subject and treatment|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by empa||105.10|96.86|
74098482|NCT02968849|147745594|OTHER||Hazard Ratio (HR)|1.02||||0.84|TWO_SIDED|95.0|0.81|1.3|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.30|0.81|0.84
73888115|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|6.0||||0.831|TWO_SIDED|95.0|-49.4|61.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||61.4|-49.4|0.8310
74049545|NCT01111331|147652039|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|100.64|STANDARD_DEVIATION|19.9||0.0021|TWO_SIDED|90.0|89.79|112.8||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for subject and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by empa||112.80|89.79|0.0021
74049546|NCT01111331|147652040|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.49|STANDARD_DEVIATION|5.7|||TWO_SIDED|90.0|95.29|101.8|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||101.80|95.29|
74049547|NCT01111331|147652041|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|97.89|STANDARD_DEVIATION|12.4||0.0001|TWO_SIDED|90.0|91.12|105.15|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||105.15|91.12|0.0001
74049548|NCT01111331|147652042|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|95.88|STANDARD_DEVIATION|4.5|||TWO_SIDED|90.0|93.4|98.43|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||98.43|93.40|
74049549|NCT01111331|147652043|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.88|STANDARD_DEVIATION|12.7||0.0001|TWO_SIDED|90.0|91.84|106.47||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||106.47|91.84|0.0001
74049550|NCT01111331|147652051|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.9|STANDARD_DEVIATION|5.3|||TWO_SIDED|90.0|95.89|102.0|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||102.00|95.89|
74049551|NCT01111331|147652058|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|96.09|STANDARD_DEVIATION|4.4|||TWO_SIDED|90.0|93.64|98.6|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||98.60|93.64|
74049552|NCT01111331|147652065|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||1.04|0.73|
74049553|NCT01111331|147652066|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||0.98|0.79|
74049554|NCT01111331|147652067|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.99|||||TWO_SIDED|95.0|0.67|1.48|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||1.48|0.67|
74098483|NCT02968849|147745594|OTHER||Hazard Ratio (HR)|1.03||||0.83|TWO_SIDED|95.0|0.81|1.31|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.31|0.81|0.83
74098484|NCT02968849|147745605|OTHER||Hazard Ratio (HR)|1.05||||0.66|TWO_SIDED|95.0|0.85|1.28|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.28|0.85|0.66
73881201|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|7.8||||0.0061|TWO_SIDED|95.0|1.79|33.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||33.87|1.79|0.0061
73881202|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0181|TWO_SIDED|95.0|1.33|21.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||21.85|1.33|0.0181
73881203|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3925|TWO_SIDED|95.0|0.53|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.99|0.53|0.3925
74049555|NCT01111331|147652068|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.9|||||TWO_SIDED|95.0|0.79|1.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.02|0.79|
74049556|NCT01111331|147652069|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|1.12|||||TWO_SIDED|95.0|0.64|1.95|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.95|0.64|
74049557|NCT01111331|147652070|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.84|0.98|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||0.98|0.84|
74049558|NCT01111331|147652071|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.97|||||TWO_SIDED|95.0|0.68|1.4|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.40|0.68|
74049559|NCT01111331|147652072|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.85|||||TWO_SIDED|95.0|0.47|1.51|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.51|0.47|
74049560|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|2.9||||0.3474|TWO_SIDED|95.0|-3.3|9.1|||ANOVA|Analysis of variance for repeated measures||Dryness - Study eye - Day 15±2 The model included fixed effect terms for time point, baseline covariate (i.e. the day 1 - pre-dose value) and treatment. Time point was specified as a repeated measurement.||9.1|-3.3|0.3474
74049561|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.1327|TWO_SIDED|95.0|-8.2|4.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Study eye - Day 15±2||4.3|-8.2|0.1327
74049562|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.1327|TWO_SIDED|95.0|-11.2|1.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Study eye - Day 15±2||1.6|-11.2|0.1327
74049563|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.2237|TWO_SIDED|95.0|-2.5|10.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||10.0|-2.5|0.2237
74049564|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.4905|TWO_SIDED|95.0|-8.4|4.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||4.1|-8.4|0.4905
74049565|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.0687|TWO_SIDED|95.0|-12.3|0.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||0.5|-12.3|0.0687
74049566|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.7609|TWO_SIDED|95.0|-4.2|5.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||5.6|-4.2|0.7609
74049567|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.6428|TWO_SIDED|95.0|-6.0|3.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||3.8|-6.0|0.6428
74049568|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.4599|TWO_SIDED|95.0|-6.9|3.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||3.2|-6.9|0.4599
74049569|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.4217|TWO_SIDED|95.0|-4.6|10.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||10.5|-4.6|0.4217
74049570|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|0.503||||-2.5|TWO_SIDED|95.0|-10.0|5.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||5.0|-10.0|-2.5
74098485|NCT02968849|147745605|OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.81|1.23|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.23|0.81|0.98
74098486|NCT02968849|147745607|OTHER||Hazard Ratio (HR)|1.15||||0.39|TWO_SIDED|95.0|0.84|1.58|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.58|0.84|0.39
74098487|NCT02968849|147745607|OTHER||Hazard Ratio (HR)|1.12||||0.5|TWO_SIDED|95.0|0.81|1.54|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.54|0.81|0.50
74098488|NCT02968849|147745618|OTHER||Hazard Ratio (HR)|1.03||||0.82|TWO_SIDED|95.0|0.8|1.33|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.33|0.80|0.82
74098489|NCT02968849|147745619|OTHER||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED|95.0|0.5|1.98|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.98|0.50|0.98
74098490|NCT02968849|147745620|OTHER||Hazard Ratio (HR)|1.08||||0.6|TWO_SIDED|95.0|0.8|1.47|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.47|0.80|0.60
74098491|NCT02968849|147745621|OTHER||Hazard Ratio (HR)|0.92||||0.71|TWO_SIDED|95.0|0.58|1.46|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.46|0.58|0.71
73881204|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.66||||0.374|TWO_SIDED|95.0|0.54|5.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.12|0.54|0.3740
73881205|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.33||||0.1753|TWO_SIDED|95.0|0.69|7.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.93|0.69|0.1753
74049571|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.4599|TWO_SIDED|95.0|-6.9|3.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||3.2|-6.9|0.4599
74049572|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.6157|TWO_SIDED|95.0|-2.6|4.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||4.4|-2.6|0.6157
74049573|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.912|TWO_SIDED|95.0|-3.7|3.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||3.3|-3.7|0.9120
74049574|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.5463|TWO_SIDED|95.0|-4.6|2.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||2.5|-4.6|0.5463
74049575|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.9065|TWO_SIDED|95.0|-5.9|5.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||5.3|-5.9|0.9065
74049576|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.5065|TWO_SIDED|95.0|-7.3|3.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||3.7|-7.3|0.5065
74049577|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.5977|TWO_SIDED|95.0|-7.1|4.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||4.2|-7.1|0.5977
74049578|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.2785|TWO_SIDED|95.0|-6.3|1.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred Vision - Study eye - Day 15±2||1.9|-6.3|0.2785
74049579|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.7454|TWO_SIDED|95.0|-4.6|3.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Study eye - Day 15±2||3.3|-4.6|0.7454
74098492|NCT02203331|147745656|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.1483|STANDARD_ERROR_OF_MEAN|0.2925||0.3875|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3875
74098493|NCT02203331|147745656|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.2484|STANDARD_ERROR_OF_MEAN|0.2975||0.2676|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.2676
74098494|NCT02203331|147745656|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.1995|STANDARD_ERROR_OF_MEAN|0.2922||0.3211|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3211
74098495|NCT02203331|147745656|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.3467|STANDARD_ERROR_OF_MEAN|0.2994||0.1721|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1721
74098496|NCT02203331|147745657|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.2736|STANDARD_ERROR_OF_MEAN|0.2878||0.231|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.231
73881206|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|12.85||||0.0195|TWO_SIDED|95.0|1.51|109.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||109.5|1.51|0.0195
73881207|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1932|TWO_SIDED|95.0|0.66|8.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.02|0.66|0.1932
74049580|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.4588|TWO_SIDED|95.0|-2.7|5.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Study eye - Day 15±2||5.9|-2.7|0.4588
74049581|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.2812|TWO_SIDED|95.0|-3.7|12.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||12.3|-3.7|0.2812
74049582|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.6811|TWO_SIDED|95.0|-6.5|9.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||9.8|-6.5|0.6811
74049583|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.5169|TWO_SIDED|95.0|-10.8|5.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||5.6|-10.8|0.5169
74049584|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.7874|TWO_SIDED|95.0|-5.9|7.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||7.8|-5.9|0.7874
74049585|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.8299|TWO_SIDED|95.0|-7.6|6.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||6.1|-7.6|0.8299
74049586|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.6386|TWO_SIDED|95.0|-8.7|5.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||5.4|-8.7|0.6386
74049587|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.0132|TWO_SIDED|95.0|1.3|10.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||10.2|1.3|0.0132
74049588|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.7177|TWO_SIDED|95.0|-5.3|3.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||3.7|-5.3|0.7177
74049589|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.0077|TWO_SIDED|95.0|-11.2|-1.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||-1.9|-11.2|0.0077
74049590|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.0301|TWO_SIDED|95.0|0.6|10.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||10.0|0.6|0.0301
74049591|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8657|TWO_SIDED|95.0|-4.3|5.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||5.1|-4.3|0.8657
74049592|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.044|TWO_SIDED|95.0|-9.7|-0.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||-0.1|-9.7|0.0440
74049593|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1351|TWO_SIDED|95.0|-1.4|9.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||9.6|-1.4|0.1351
74049594|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.8821|TWO_SIDED|95.0|-6.0|5.2|||ANCOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||5.2|-6.0|0.8821
74049595|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.1208|TWO_SIDED|95.0|-10.3|1.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||1.3|-10.3|0.1208
74049596|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.944|TWO_SIDED|95.0|-3.3|3.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||3.5|-3.3|0.9440
74049597|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.4903|TWO_SIDED|95.0|-2.2|4.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||4.5|-2.2|0.4903
74049598|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.5364|TWO_SIDED|95.0|-2.3|4.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||4.3|-2.3|0.5364
74049599|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.51|TWO_SIDED|95.0|-2.9|5.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||5.7|-2.9|0.5100
74049600|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.1132|TWO_SIDED|95.0|-0.9|7.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||7.8|-0.9|0.1132
74049601|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3457|TWO_SIDED|95.0|-2.4|6.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||6.5|-2.4|0.3457
74049602|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.0185|TWO_SIDED|95.0|0.8|7.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||7.9|0.8|0.0185
74049603|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.0408|TWO_SIDED|95.0|0.2|7.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||7.1|0.2|0.0408
74049604|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.6992|TWO_SIDED|95.0|-4.4|3.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||3.0|-4.4|0.6992
74098497|NCT02203331|147745657|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.3234|STANDARD_ERROR_OF_MEAN|0.2927||0.1865|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1865
74098498|NCT02203331|147745657|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.3081|STANDARD_ERROR_OF_MEAN|0.2875||0.1955|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1955
74098499|NCT02203331|147745657|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.3781|STANDARD_ERROR_OF_MEAN|0.2944||0.1416|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1416
74098500|NCT02203331|147745658|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.0081|STANDARD_ERROR_OF_MEAN|0.2832||0.5794|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.5794
74098501|NCT02203331|147745658|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.1148|STANDARD_ERROR_OF_MEAN|0.288||0.4301|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.4301
74098502|NCT02203331|147745658|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.0401|STANDARD_ERROR_OF_MEAN|0.2829||0.5337|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.5337
74098503|NCT02203331|147745658|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.1835|STANDARD_ERROR_OF_MEAN|0.2899||0.3396|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3396
74098504|NCT02091466|147745663|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Analysis of covariance for repeated measures (ANCOVA), adjusted for baseline values, compared tympanic temperatures between the groups. Statistical significance was established at p \< 0.05, and the statistical analysis was performed using SPSS (Statistical Package for the Social Sciences) software version 20.||||<0.05
74098505|NCT04036799|147745699|OTHER|Categorical variables were summarized using frequencies and proportions.|Cumulative proportion of events at 5 yrs|9.1|||||TWO_SIDED|95.0||||||||||||
74098506|NCT02784444|147745712|SUPERIORITY||Odds Ratio (OR)|0.89||||0.747|TWO_SIDED|95.0|0.44|1.81||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||1.81|0.44|0.747
74098507|NCT02784444|147745712|SUPERIORITY||Odds Ratio (OR)|1.22||||0.575|TWO_SIDED|95.0|0.6|2.48||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.48|0.60|0.575
74098508|NCT02784444|147745712|SUPERIORITY||Odds Ratio (OR)|1.64||||0.158|TWO_SIDED|95.0|0.83|3.27||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.27|0.83|0.158
74098509|NCT02784444|147745713|SUPERIORITY||Odds Ratio (OR)|1.09||||0.828|TWO_SIDED|95.0|0.49|2.42||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.42|0.49|0.828
74098510|NCT02784444|147745713|SUPERIORITY||Odds Ratio (OR)|1.5||||0.299|TWO_SIDED|95.0|0.7|3.21||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.21|0.70|0.299
74098511|NCT02784444|147745713|SUPERIORITY||Odds Ratio (OR)|1.82||||0.116|TWO_SIDED|95.0|0.86|3.82||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.82|0.86|0.116
74098512|NCT02784444|147745714|SUPERIORITY||Odds Ratio (OR)|1.19||||0.657|TWO_SIDED|95.0|0.55|2.55||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.55|0.55|0.657
74098513|NCT02784444|147745714|SUPERIORITY||Odds Ratio (OR)|1.45||||0.332|TWO_SIDED|95.0|0.69|3.06||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.06|0.69|0.332
74098514|NCT02784444|147745714|SUPERIORITY||Odds Ratio (OR)|1.51||||0.27|TWO_SIDED|95.0|0.72|3.16||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.16|0.72|0.270
74098515|NCT02784444|147745715|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.392|TWO_SIDED|95.0|-0.7|0.3||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.3|-0.7|0.392
74098516|NCT02784444|147745715|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.023|TWO_SIDED|95.0|-1.1|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-1.1|0.023
74098517|NCT02784444|147745715|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.028|TWO_SIDED|95.0|-1.0|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-1.0|0.028
74098518|NCT02784444|147745716|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.224|TWO_SIDED|95.0|-0.4|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.4|0.224
74098519|NCT02784444|147745716|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.096|TWO_SIDED|95.0|-0.4|0.0||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.0|-0.4|0.096
74098520|NCT02784444|147745716|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.007|TWO_SIDED|95.0|-0.6|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-0.6|0.007
73881208|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0537|TWO_SIDED|95.0|0.98|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.86|0.98|0.0537
73881209|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|7.72||||0.0144|TWO_SIDED|95.0|1.5|39.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||39.66|1.50|0.0144
74098521|NCT02784444|147745717|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.488|TWO_SIDED|95.0|-0.1|0.2||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.2|-0.1|0.488
74098522|NCT02784444|147745717|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.291|TWO_SIDED|95.0|-0.3|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.3|0.291
74098523|NCT02784444|147745717|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.595|TWO_SIDED|95.0|-0.2|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.2|0.595
74098524|NCT02784444|147745718|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.416|TWO_SIDED|95.0|-0.4|0.2||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.2|-0.4|0.416
74098525|NCT02784444|147745718|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.056|TWO_SIDED|95.0|-0.5|0.0||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.0|-0.5|0.056
74098526|NCT02784444|147745718|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.4|0.220
74098527|NCT02784444|147745719|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.928|TWO_SIDED|95.0|-0.3|0.3||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.3|-0.3|0.928
74098528|NCT02784444|147745719|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.244|TWO_SIDED|95.0|-0.5|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.5|0.244
74049605|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|5.9||||0.0905|TWO_SIDED|95.0|-1.0|12.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||12.8|-1.0|0.0905
74049606|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.3054|TWO_SIDED|95.0|-3.4|10.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||10.4|-3.4|0.3054
74049607|NCT03031327|147652087|SUPERIORITY||Mean Difference (Final Values)|0.5024||||0.5024|TWO_SIDED|95.0|-9.6|4.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||4.8|-9.6|0.5024
74049608|NCT03031327|147652089|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.1226|TWO_SIDED|95.0|-0.1|0.8|||Student t-test pooled|Student t-test with pool method for estimating common variance on changes from baseline in ocular surface vital staining||Study eye - Day 15±2 pre-dose||0.8|-0.1|0.1226
74049609|NCT03031327|147652089|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.2854|TWO_SIDED|95.0|-0.2|0.7|||Student t-test pooled|Student t-test with pool method for estimating common variance on changes from baseline in ocular surface vital staining||Study eye - Day 15±2 pre-dose||0.7|-0.2|0.2854
74049610|NCT03031327|147652089|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.6525|TWO_SIDED|95.0|-0.6|0.4|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining -||Student t-test on changes from baseline in ocular surface vital staining - Study eye - Day 15±2 pre-dose||0.4|-0.6|0.6525
74049611|NCT03031327|147652089|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8843|TWO_SIDED|95.0|-0.4|0.5|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining -||Non Study eye - Day 15±2 pre-dose||0.5|-0.4|0.8843
74049612|NCT03031327|147652089|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0806|TWO_SIDED|95.0|-0.6|0.0|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining||Non Study eye - Day 15±2 pre-dose||0.0|-0.6|0.0806
74049613|NCT03031327|147652089|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0628|TWO_SIDED|95.0|-0.7|0.0|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining||Non Study eye - Day 15±2 pre-dose||0.0|-0.7|0.0628
74049614|NCT03031327|147652090|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.2004|TWO_SIDED|95.0|-0.2|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.9|-0.2|0.2004
74049615|NCT03031327|147652090|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5413|TWO_SIDED|95.0|-0.3|0.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.6|-0.3|0.5413
74049616|NCT03031327|147652090|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.4607|TWO_SIDED|95.0|-0.8|0.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.4|-0.8|0.4607
74049617|NCT03031327|147652090|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1248|TWO_SIDED|95.0|-0.2|1.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||1.4|-0.2|0.1248
74049618|NCT03031327|147652090|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.0624|TWO_SIDED|95.0|0.0|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||1.1|0.0|0.0624
74049619|NCT03031327|147652090|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7927|TWO_SIDED|95.0|-1.0|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||0.8|-1.0|0.7927
74049620|NCT03031327|147652091|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9717|TWO_SIDED|95.0|-0.6|0.7|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Study eye - Day 15±2 pre-dose||0.7|-0.6|0.9717
74049621|NCT03031327|147652091|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7386|TWO_SIDED|95.0|-0.6|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Study eye - Day 15±2 pre-dose||0.9|-0.6|0.7386
74049622|NCT03031327|147652091|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7498|TWO_SIDED|95.0|-0.6|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Study eye - Day 15±2 pre-dose||0.8|-0.6|0.7498
74049623|NCT03031327|147652091|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.3229|TWO_SIDED|95.0|-1.1|0.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||0.4|-1.1|0.3229
74049624|NCT03031327|147652091|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.57|TWO_SIDED|95.0|-0.5|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||0.9|-0.5|0.5700
74049625|NCT03031327|147652091|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1197|TWO_SIDED|95.0|-0.2|1.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||1.3|-0.2|0.1197
74098529|NCT02784444|147745719|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.228|TWO_SIDED|95.0|-0.5|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.5|0.228
74098530|NCT03323437|147745758|OTHER|two way anova|||||<|0.01|||||||ANOVA|||||||<0.01
74098531|NCT03323437|147745759|OTHER|two way anova||||||0.68|||||||ANOVA|||||||.68
74098532|NCT03323437|147745760|OTHER|two way anova||||||0.03|||||||ANOVA|||||||.03
74098533|NCT03323437|147745761|OTHER|two way anova||||||0.01|||||||ANOVA|||||||.01
74098534|NCT03323437|147745762|OTHER|two sided t test||||||0.59|||||||t-test, 2 sided|||||||.59
74098535|NCT03323437|147745763|OTHER|two sided t test||||||0.45|||||||t-test, 2 sided|||||||.45
74098536|NCT03323437|147745764|OTHER|two way anova||||||0.32|||||||ANOVA|||||||.32
73881210|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.29||||0.666|TWO_SIDED|95.0|0.41|4.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.09|0.41|0.6660
74049626|NCT03031327|147652092|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8787|TWO_SIDED|95.0|-0.6|0.6|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.6|-0.6|0.8787
74049627|NCT03031327|147652092|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8159|TWO_SIDED|95.0|-0.5|0.7|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.7|-0.5|0.8159
74049628|NCT03031327|147652092|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.6525|TWO_SIDED|95.0|-0.4|0.6|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.6|-0.4|0.6525
74049629|NCT03031327|147652092|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.334|TWO_SIDED|95.0|-1.0|0.4|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.4|-1.0|0.3340
74049630|NCT03031327|147652092|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9749|TWO_SIDED|95.0|-0.7|0.7|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.7|-0.7|0.9749
74049631|NCT03031327|147652092|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.1984|TWO_SIDED|95.0|-0.2|0.9|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.9|-0.2|0.1984
74049632|NCT03031327|147652093|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.6497|TWO_SIDED|95.0|-10.5|16.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||16.4|-10.5|0.6497
74049633|NCT03031327|147652093|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.1443|TWO_SIDED|95.0|-16.5|2.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||2.6|-16.5|0.1443
74049634|NCT03031327|147652093|SUPERIORITY||Mean Difference (Final Values)|-9.9||||0.0751|TWO_SIDED|95.0|-20.9|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||1.1|-20.9|0.0751
74049635|NCT03031327|147652093|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.5015|TWO_SIDED|95.0|-7.9|15.5|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||15.5|-7.9|0.5015
74049636|NCT03031327|147652093|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.3217|TWO_SIDED|95.0|-12.5|4.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||4.4|-12.5|0.3217
74049637|NCT03031327|147652093|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.1026|TWO_SIDED|95.0|-17.5|1.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||1.8|-17.5|0.1026
74049638|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
74049639|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
74049640|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
73881211|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7923|TWO_SIDED|95.0|0.37|3.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.62|0.37|0.7923
73881212|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.73||||0.3796|TWO_SIDED|95.0|0.51|5.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.90|0.51|0.3796
74049641|NCT03031327|147652094|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||0.4101
74049642|NCT03031327|147652094|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||0.4101
74049643|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||1.000
74049644|NCT03031327|147652094|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||0.4101
74049645|NCT03031327|147652094|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||0.4101
74049646|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||1.000
74049647|NCT03031327|147652094|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||0.4101
74049648|NCT03031327|147652094|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||0.4101
74049649|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||1.000
74098537|NCT03323437|147745765|OTHER|two way anova||||||0.6|||||||ANOVA|||||||.60
74049650|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
74049651|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
74049652|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
74049653|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
74049654|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
74049655|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
74049656|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
74049657|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
74049658|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
74049659|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
74049660|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
74049661|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
74049662|NCT03031327|147652094|SUPERIORITY|||||||0.5267|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.5267
74049663|NCT03031327|147652094|SUPERIORITY|||||||0.2633|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.2633
74049664|NCT03031327|147652094|SUPERIORITY|||||||0.6552|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.6552
74049665|NCT03031327|147652094|SUPERIORITY|||||||0.1262|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||||0.1262
74049666|NCT03031327|147652094|SUPERIORITY|||||||0.2094|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||||0.2094
74049667|NCT03031327|147652094|SUPERIORITY||Hodges Lehmann estimation|-1.0||||0.0377|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||0.0|-1.0|0.0377
74049668|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
74049669|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
74049670|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
74049671|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
74049672|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
74049673|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
74049674|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
74049675|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
74049676|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
74049677|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
74049678|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
74049679|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
74049680|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
74049681|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
74049682|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
73881213|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0874|TWO_SIDED|95.0|0.81|21.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||21.73|0.81|0.0874
73881214|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1925|TWO_SIDED|95.0|0.62|10.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.96|0.62|0.1925
73881215|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0651|TWO_SIDED|95.0|0.92|17.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.38|0.92|0.0651
73881216|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5361|TWO_SIDED|95.0|0.44|4.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.81|0.44|0.5361
73881217|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6258|TWO_SIDED|95.0|0.42|4.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.17|0.42|0.6258
73881218|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6275|TWO_SIDED|95.0|0.43|4.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.06|0.43|0.6275
74049683|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
74049684|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
74049685|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
74049686|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
74049687|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
74049688|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
73881219|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.21||||0.2212|TWO_SIDED|95.0|0.62|7.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.90|0.62|0.2212
73881220|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|11.13||||0.028|TWO_SIDED|95.0|1.3|95.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||95.49|1.30|0.0280
74049689|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
74049690|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
74049691|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
74049692|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
74049693|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
74049694|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
74049695|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
74098538|NCT03323437|147745766|OTHER|two way anova||||||0.34|||||||ANOVA|||||||.34
74098539|NCT03323437|147745767|OTHER|two way anova||||||0.35|||||||ANOVA|||||||.35
74098540|NCT03323437|147745768|OTHER|fisher's exact||||||0.66|||||||Fisher Exact|||||||.66
74098541|NCT03323437|147745769|OTHER|two sided t test||||||0.04|||||||t-test, 2 sided|||||||.04
74098542|NCT03323437|147745770|OTHER|fisher's exact test||||||1|||||||Fisher Exact|||||||1
74098543|NCT03257865|147745800|SUPERIORITY||Treatment difference|-1.62|||=|0.1011|TWO_SIDED|95.0|-3.56|0.32|||mixed-effect model repeated measure||"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."|||0.32|-3.56|=0.1011
74098544|NCT03200912|147745850|EQUIVALENCE|Primary Efficacy Endpoint - AK Complete Clearance Rates at Day 57 (PP and mITT Populations)|Mean Difference (Net)|2.29|||||TWO_SIDED|90.0|-7.55|12.14||||||||12.14|-7.55|
74098545|NCT02309138|147745851|SUPERIORITY||Risk Ratio (RR)|0.903||||0.668|TWO_SIDED|97.5|0.538|1.516||Each co-primary hypothesis was tested at the 2.5% significance level.|Regression, Logistic|In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.|A relative risk \< 1 represents a benefit in the direction of the IADPSG group, while a value \> 1 represents a benefit towards the CC group.|Co-primary hypotheses #1: women diagnosed using the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those diagnosed using the Carpenter-Coustan criteria.||1.516|0.538|0.668
74098546|NCT02309138|147745851|SUPERIORITY||Risk Ratio (RR)|0.853||||0.853|TWO_SIDED|97.5|0.493|1.475||Each co-primary hypothesis was tested at the 2.5% significance level.|Regression, Logistic|In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.||"Co-primary hypothesis #2: women classified as no gestational diabetes by the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those classified in the Carpenter-Coustan criteria."||1.475|0.493|0.853
74098547|NCT02309138|147745852|SUPERIORITY||Risk Ratio (RR)|1.046||||0.6669|TWO_SIDED|95.0|0.847|1.291|||Regression, Logistic|||||1.291|0.847|0.6669
74098548|NCT02309138|147745852|SUPERIORITY||Risk Ratio (RR)|1.033||||0.8394|TWO_SIDED|95.0|0.816|1.307|||Regression, Logistic|||||1.307|0.816|0.8394
74049696|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
74049697|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
74049698|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
74098549|NCT02309138|147745853|SUPERIORITY||Risk Ratio (RR)|0.987||||0.9335|TWO_SIDED|95.0|0.74|1.318|||Regression, Logistic|||||1.318|0.740|0.9335
73881221|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|4.88||||0.0589|TWO_SIDED|95.0|0.94|25.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||25.32|0.94|0.0589
74098550|NCT02309138|147745853|SUPERIORITY||Risk Ratio (RR)|1.022||||0.926|TWO_SIDED|95.0|0.742|1.407|||Regression, Logistic|||||1.407|0.742|0.9260
74098551|NCT02309138|147745854|SUPERIORITY||Risk Ratio (RR)|1.4||||0.0322|TWO_SIDED|95.0|1.027|1.909|||Regression, Logistic|||||1.909|1.027|0.0322
74098552|NCT02309138|147745854|SUPERIORITY||Risk Ratio (RR)|1.233||||0.2643|TWO_SIDED|95.0|0.864|1.76|||Regression, Logistic|||||1.760|0.864|0.2643
74098553|NCT03421730|147745885|OTHER||Geometric mean ratio (%)|8.69|||||TWO_SIDED||||||||A: n=6; D: n=5||The intra-subject coefficient of variation was 25.33%.|||
73881222|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.63||||0.0799|TWO_SIDED|95.0|0.86|15.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.39|0.86|0.0799
74049699|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
74098554|NCT03421730|147745885|OTHER||Geometric mean ratio (%)|28.18|||||TWO_SIDED||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.|||
74098555|NCT03421730|147745885|OTHER||Geometric mean ratio (%)|59.51|||||TWO_SIDED||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.|||
74098556|NCT03421730|147745886|OTHER||Geometric mean ratio (%)|13.35|||||TWO_SIDED||||||||A: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%.|||
74098557|NCT03421730|147745886|OTHER||Geometric mean ratio (%)|35.97|||||TWO_SIDED||||||||B: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%|||
74098558|NCT03421730|147745886|OTHER||Geometric mean ratio (%)|76.98|||||TWO_SIDED||||||||C: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%|||
74098559|NCT03421730|147745887|OTHER||Geometric mean ratio (%)|9.55|||||TWO_SIDED||||||||A: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
74098560|NCT03421730|147745887|OTHER||Geometric mean ratio (%)|32.42|||||TWO_SIDED||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
74098561|NCT03421730|147745887|OTHER||Geometric mean ratio (%)|59.75|||||TWO_SIDED||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
74049700|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
74049701|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
74049702|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
74049703|NCT03031327|147652094|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
74098562|NCT00118534|147745901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.007|TWO_SIDED|95.0|1.22|3.59|||Regression, Logistic|||The target sample size (n=1400)was designed to have 90% power to detect the difference between 6% and 11% prolonged abstinence rates in SCC and IC, respectively, using a 2-sided .05 level Chi-square test. Final enrollment was 943. The recruitment period was not extended because the achieved sample size provided 78% power to detect the hypothesized prolonged abstinence rates, and the study continued to the end of planned follow-up.||3.59|1.22|0.007
74049704|NCT03031327|147652095|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.5842|TWO_SIDED|95.0|-1.5|2.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||2.6|-1.5|0.5842
74049705|NCT03031327|147652095|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4606|TWO_SIDED|95.0|-2.2|1.0|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||1.0|-2.2|0.4606
74049706|NCT03031327|147652095|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.2319|TWO_SIDED|95.0|-3.0|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||0.8|-3.0|0.2319
74049707|NCT03031327|147652095|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.6018|TWO_SIDED|95.0|-2.3|1.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.4|-2.3|0.6018
73881223|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1112|TWO_SIDED|95.0|0.78|10.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.87|0.78|0.1112
74049708|NCT03031327|147652095|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4857|TWO_SIDED|95.0|-2.2|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.1|-2.2|0.4857
74049709|NCT03031327|147652095|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.9015|TWO_SIDED|95.0|-2.0|1.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.8|-2.0|0.9015
74049710|NCT03031327|147652096|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.3574|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.3|-0.1|0.3574
74049711|NCT03031327|147652096|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.3574|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.3|-0.1|0.3574
74049712|NCT03031327|147652096|SUPERIORITY||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0|0.0|0.0||P-value is NA due to the measured values of corneal sensitivity equal to zero.|Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.0|0.0|00
74049713|NCT03031327|147652096|SUPERIORITY||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0|0.0|0.0||P-value is NA due to the measured values of corneal sensitivity equal to zero.|Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.0|0.0|00
74049714|NCT03031327|147652096|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.3|-0.1|0.1
74049715|NCT03031327|147652096|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.3|-0.1|0.1
74098563|NCT00118534|147745902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.58|3.74|||Regression, Logistic|||||3.74|1.58|<0.001
74098564|NCT01955083|147745946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_DEVIATION|16.0|<|0.05|TWO_SIDED|95.0|-14.4|48.4|||Wilcoxon (Mann-Whitney)|||We hypothesized that pillar implant provide a better efficacy in the treatment of snoring than radiofrequency surgery. The sample size was estimated using the primary outcome effects (VAS) in two previously published studies (Friedman 2008; Fang 2004). Using a two-tailed Wilcoxon signed-rank test (normal parent distribution; effect size, 1.0; type I error, 0.05; power, 80%), we got a sample size of 11. For considering a 20% drop-out rate, we needed at least 14 participants.||48.4|-14.4|<0.05
73881224|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0959|TWO_SIDED|95.0|0.84|9.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.11|0.84|0.0959
74049716|NCT00211536|147652097|NON_INFERIORITY_OR_EQUIVALENCE|For the average A1C, the goal was to show non-inferiority of MIP compared to SC. The minimal clinically relevant increase in A1C (%) was set at 0.50%. The between-subjects standard deviation of A1C was assumed to be 1.0% based on previous studies.|Least square means|0.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|ONE_SIDED|95.0||0.5|||Mixed Models Analysis|Repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed to compare A1C trends over time between the treatment groups||Sample size calculations were performed on the primary endpoint: the average glycosylated hemoglobin (A1C). Sample size was estimated using a two-sample, one-sided t-test with a significance level of 0.05. The projected sample size of 50 subjects per treatment group provides 79% power to reject the null hypothesis in favor of the alternative hypothesis that the average A1C in both the MIP and SC groups are equivalent, assuming an effect size of 0.50% and a standard deviation of 1.0%.||0.5||<0.05
74049717|NCT00003389|147652102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|TWO_SIDED||||||Log Rank|Stratified log rank test was performed.||||||0.32
74049718|NCT00003389|147652103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|TWO_SIDED||||||Log Rank|Stratified log rank test was performed.||||||0.86
74098565|NCT01955083|147745947|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74098566|NCT01955083|147745948|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74098567|NCT01955083|147745949|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74049719|NCT00908050|147652107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|||||||Chi-squared|||The averaged data calculated from three nights in each recording period for each subject will be submitted to statistical analysis. Descriptive and non-parametric statistics will be used for the secondary end-points.||||0.0394
73881225|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.62||||0.3886|TWO_SIDED|95.0|0.54|4.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.85|0.54|0.3886
74098568|NCT01955083|147745950|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74098569|NCT01955083|147745951|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74098570|NCT01955083|147745952|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74098571|NCT01955083|147745953|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74098572|NCT01955083|147745954|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74098573|NCT01955083|147745955|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74098574|NCT01955083|147745956|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74098575|NCT01955083|147745957|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74098576|NCT01955083|147745958|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
74098577|NCT02871492|147745960|SUPERIORITY|||||||0.4294|||||||Cochran-Mantel-Haenszel|||||||0.4294
74098578|NCT02256436|147745961|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.41648|TWO_SIDED|95.0|0.81|1.19||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - All Participants||1.19|0.81|0.41648
74098579|NCT02256436|147745962|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.00224|TWO_SIDED|95.0|0.59|0.91||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - All Participants (Note: ECOG PS=Eastern Cooperative Oncology Group Performance Status)||0.91|0.59|0.00224
74098580|NCT02256436|147745963|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.26443|TWO_SIDED|95.0|0.68|1.24||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - PD-L1 positive participants||1.24|0.68|0.26443
74098581|NCT02256436|147745964|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61||||0.00239|TWO_SIDED|95.0|0.43|0.86||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - PD-L1 positive participants||0.86|0.43|0.00239
73881226|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0864|TWO_SIDED|95.0|0.85|10.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.52|0.85|0.0864
74049720|NCT04806165|147652125|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.26|STANDARD_ERROR_OF_MEAN|0.26||0.309|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the motivational interviewing (MI) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.309
74049721|NCT04806165|147652125|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.34|STANDARD_ERROR_OF_MEAN|0.26||0.19|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the personalized recommendation (PR) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.190
74049722|NCT04806165|147652125|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.69|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the psychoeducation (PE) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.690
74098582|NCT02256436|147745965|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.23958|TWO_SIDED|95.0|0.61|1.28||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - Strongly PD-L1 positive participants||1.28|0.61|0.23958
74098583|NCT02256436|147745966|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.00483|TWO_SIDED|95.0|0.37|0.88||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - Strongly PD-L1 positive participants||0.88|0.37|0.00483
73881227|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|14.22||||0.0145|TWO_SIDED|95.0|1.69|119.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||119.5|1.69|0.0145
73881228|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|13.08||||0.018|TWO_SIDED|95.0|1.56|110.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||110.0|1.56|0.0180
73881229|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|18.53||||0.008|TWO_SIDED|95.0|2.14|160.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||160.6|2.14|0.0080
74049723|NCT04806165|147652125|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.54|STANDARD_ERROR_OF_MEAN|0.26||0.038|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the repeated administration (RA) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||0.038
74049724|NCT04806165|147652125|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.735|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 2 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.735
74049725|NCT04806165|147652125|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.91|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 6 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.001
74098584|NCT02256436|147745969|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|17.2||||0.00061|TWO_SIDED|95.0|6.8|29.4||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - Strongly PD-L1 Positive Participants||29.4|6.8|0.00061
74098585|NCT02256436|147745970|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|15.6||||0.00049|TWO_SIDED|95.0|6.5|25.7||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - PD-L1 Positive Participants||25.7|6.5|0.00049
73881230|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0236|TWO_SIDED|95.0|1.24|20.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||20.65|1.24|0.0236
73881231|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4303|TWO_SIDED|0.4303|0.5|5.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.07|0.50|0.4303
73881232|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5529|TWO_SIDED|95.0|0.45|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.39|0.45|0.5529
73881233|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.87||||0.3268|TWO_SIDED|95.0|0.53|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.55|0.53|0.3268
73881234|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|10.02||||0.0343|TWO_SIDED|95.0|1.19|84.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||84.66|1.19|0.0343
73881235|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|9.45||||0.0391|TWO_SIDED|95.0|1.12|79.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||79.82|1.12|0.0391
73881236|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|13.31||||0.0187|TWO_SIDED|95.0|1.54|115.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||115.1|1.54|0.0187
73881237|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1475|TWO_SIDED|95.0|0.71|9.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.47|0.71|0.1475
73881238|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.19||||0.2161|TWO_SIDED|95.0|0.63|7.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.55|0.63|0.2161
73881239|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.79||||0.3478|TWO_SIDED|95.0|0.53|6.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.04|0.53|0.3478
73881240|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.22||||0.2269|TWO_SIDED|95.0|0.61|8.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.14|0.61|0.2269
73881241|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0683|TWO_SIDED|95.0|0.89|24.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||24.35|0.89|0.0683
74098586|NCT02256436|147745971|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|10.0||||0.00068|TWO_SIDED|95.0|3.9|16.2||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - All Participants||16.2|3.9|0.00068
73881242|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0228|TWO_SIDED|95.0|1.31|38.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||38.49|1.31|0.0228
73881243|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.95||||0.062|TWO_SIDED|95.0|0.93|16.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.72|0.93|0.0620
73881244|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.18||||0.2251|TWO_SIDED|95.0|0.62|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.67|0.62|0.2251
73881245|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7908|TWO_SIDED|95.0|0.35|3.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.99|0.35|0.7908
73881246|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3735|TWO_SIDED|95.0|0.48|7.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.06|0.48|0.3735
73881247|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.49||||0.1856|TWO_SIDED|95.0|0.64|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.64|0.64|0.1856
74098587|NCT02256436|147745972|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.07066|TWO_SIDED|95.0|0.53|1.11||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - Strongly PD-L1 Positive Participants||1.11|0.53|0.07066
74098588|NCT02256436|147745973|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.08745|TWO_SIDED|95.0|0.6|1.1||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - PD-L1 Positive Participants||1.10|0.60|0.08745
74098589|NCT02256436|147745974|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.05328|TWO_SIDED|95.0|0.71|1.04||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - All Participants||1.04|0.71|0.05328
74098590|NCT02256436|147745975|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|21.5||||9e-05|TWO_SIDED|95.0|10.1|34.2||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - Strongly PD-L1 Positive Participants||34.2|10.1|0.00009
74098591|NCT02256436|147745976|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|21.0||||2e-05|TWO_SIDED|95.0|11.1|31.5||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - PD-L1 Positive Participants||31.5|11.1|0.00002
74098592|NCT02256436|147745977|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|13.8||||1e-05|TWO_SIDED|95.0|7.4|20.3||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - All Participants||20.3|7.4|0.00001
74098593|NCT00468650|147746027|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.96|STANDARD_DEVIATION|5.19|<|0.001||95.0|10.0|11.93||"Statistical significance will be declared if the p-value is \<0.05.~Change from Baseline: Week 6 (LOCF) minus Baseline"|t-test, 2 sided|single sample t-test||Primary hypothesis to be tested is whether there is a significant improvement in the IIEF EF domain at the end of the 100 mg period, as compared to the baseline (Week 0) score. Sample size (N=115) provides more than 90% power to detect a change from baseline of 10 in the primary efficacy variable, assuming a standard deviation of 9, using the two-sided, single-sample t-test with significance level (alpha) of 0.05.||11.93|10.00|<0.001
74018815|NCT04871711|147589952|SUPERIORITY||Risk Difference (RD)|17.2|||<|0.001|TWO_SIDED|95.0|10.1|24.3||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||24.3|10.1|<0.001
74098594|NCT00468650|147746028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.14|STANDARD_DEVIATION|5.21|<|0.001||95.0|6.17|8.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||8.11|6.17|<0.001
74098595|NCT00468650|147746028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.57|STANDARD_DEVIATION|5.43|<|0.001||95.0|9.56|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||11.59|9.56|<0.001
74098596|NCT00468650|147746028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.93|STANDARD_DEVIATION|5.26|<|0.001||95.0|9.93|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||11.92|9.93|<0.001
74098597|NCT00468650|147746028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.95|STANDARD_DEVIATION|5.21|<|0.001||95.0|9.97|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 endpoint minus baseline||11.92|9.97|<0.001
74098598|NCT00468650|147746029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.48|STANDARD_DEVIATION|3.97|<|0.001||95.0|2.74|4.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.23|2.74|<0.001
74098599|NCT00468650|147746029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.88|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.05|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.71|3.05|<0.001
74098600|NCT00468650|147746029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.86|STANDARD_DEVIATION|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.67|3.04|<0.001
74098601|NCT00468650|147746029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.86|STANDARD_DEVIATION|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.67|3.04|<0.001
74098602|NCT00468650|147746030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.89|STANDARD_DEVIATION|2.4|<|0.001||95.0|1.45|2.34||p-value not adjusted for multiple comparisons. Threshold for significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||2.34|1.45|<0.001
74049726|NCT04806165|147652125|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.73|STANDARD_ERROR_OF_MEAN|0.3||0.014|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 14 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.014
74049727|NCT04806165|147652126|SUPERIORITY|Gender, age, and race were included as auxiliary variables to improve imputation quality. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. For sensitivity analysis, models were run again using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.53||||0.25|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|||Analyses were conducted to determine the effects of each of the four chatbot components on secondary outcomes. This analysis in particular explores the effects of the motivational interviewing component (MI) on participant willingness to seek psychotherapy for concerns their disordered weight and shape behaviors and thoughts since engagement with the intervention. Linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||||0.25
74049728|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.36||||0.44|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the psychoeducation component (PE) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.44
74098603|NCT00468650|147746030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.46|STANDARD_DEVIATION|2.32|<|0.001||95.0|2.02|2.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||2.89|2.02|<0.001
74098604|NCT00468650|147746030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.59|STANDARD_DEVIATION|2.44|<|0.001||95.0|2.13|3.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||3.05|2.13|<0.001
74098605|NCT00468650|147746030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.63|STANDARD_DEVIATION|2.45|<|0.001||95.0|2.17|3.08||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||3.08|2.17|<0.001
74098606|NCT00468650|147746030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.59|STANDARD_DEVIATION|2.42|<|0.001||95.0|2.14|3.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||3.04|2.14|<0.001
74098607|NCT00468650|147746031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.61|STANDARD_DEVIATION|1.51|<|0.001||95.0|0.32|0.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||0.89|0.32|<0.001
74098608|NCT00468650|147746031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.75|STANDARD_DEVIATION|1.46|<|0.001||95.0|0.47|1.02||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.02|0.47|<0.001
74098609|NCT00468650|147746031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.74|STANDARD_DEVIATION|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.01|0.47|<0.001
74098610|NCT00468650|147746031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.74|STANDARD_DEVIATION|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.01|0.47|<0.001
74098611|NCT00468650|147746032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.43|STANDARD_DEVIATION|1.87|<|0.001||95.0|1.09|1.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||1.78|1.09|<0.001
74098612|NCT00468650|147746032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.86|<|0.001||95.0|1.65|2.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||2.35|1.65|<0.001
74098613|NCT00468650|147746032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.25|STANDARD_DEVIATION|1.91|<|0.001||95.0|1.89|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||2.62|1.89|<0.001
74098614|NCT00468650|147746032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.26|STANDARD_DEVIATION|1.94|<|0.001||95.0|1.9|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||2.62|1.90|<0.001
74098615|NCT00468650|147746032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.28|STANDARD_DEVIATION|1.93|<|0.001||95.0|1.91|2.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||2.64|1.91|<0.001
74098616|NCT00468650|147746033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.55|STANDARD_DEVIATION|1.41|<|0.001||95.0|0.29|0.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||0.82|0.29|<0.001
74098617|NCT00468650|147746033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.81|STANDARD_DEVIATION|1.47|<|0.001||95.0|0.53|1.09||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.09|0.53|<0.001
74098618|NCT00468650|147746033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83|STANDARD_DEVIATION|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.11|0.55|<0.001
74098619|NCT00468650|147746033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83|STANDARD_DEVIATION|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.11|0.55|<0.001
74098620|NCT00468650|147746034|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.18|STANDARD_DEVIATION|2.42|<|0.001||95.0|2.73|3.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.63|2.73|<0.001
74098621|NCT00468650|147746034|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.38|STANDARD_DEVIATION|2.39|<|0.001||95.0|3.94|4.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.83|3.94|<0.001
74098622|NCT00468650|147746034|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.73|STANDARD_DEVIATION|2.53|<|0.001||95.0|4.25|5.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||5.21|4.25|<0.001
74098623|NCT00468650|147746034|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.7|STANDARD_DEVIATION|2.52|<|0.001||95.0|4.23|5.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||5.17|4.23|<0.001
74098624|NCT00468650|147746034|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.72|STANDARD_DEVIATION|2.52|<|0.001||95.0|4.25|5.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||5.19|4.25|<0.001
74098625|NCT00468650|147746035|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.1|<|0.001||95.0|0.8|1.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.59|0.80|<0.001
74098626|NCT00468650|147746035|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.2|<|0.001||95.0|1.12|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.95|1.12|<0.001
74098627|NCT00468650|147746035|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.95|1.13|<0.001
74098628|NCT00468650|147746035|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.95|1.13|<0.001
74098629|NCT00468650|147746036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.73|STANDARD_DEVIATION|2.38|<|0.001||95.0|2.28|3.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.17|2.28|<0.001
74098630|NCT00468650|147746036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.67|STANDARD_DEVIATION|2.49|<|0.001||95.0|3.2|4.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.14|3.20|<0.001
74098631|NCT00468650|147746036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.92|STANDARD_DEVIATION|2.52|<|0.001||95.0|3.44|4.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||4.40|3.44|<0.001
74098632|NCT00468650|147746036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|2.53|<|0.001||95.0|3.44|4.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||4.38|3.44|<0.001
74098633|NCT00468650|147746036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.89|STANDARD_DEVIATION|2.53|<|0.001||95.0|3.42|4.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||4.37|3.42|<0.001
74098634|NCT00468650|147746037|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.97|STANDARD_DEVIATION|1.88|<|0.001||95.0|0.62|1.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.32|0.62|<0.001
74098635|NCT00468650|147746037|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.21|STANDARD_DEVIATION|1.92|<|0.001||95.0|0.85|1.57||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.57|0.85|<0.001
74098636|NCT00468650|147746037|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.55|0.84|<0.001
74049729|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.25||||0.44|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the personalized recommendation component (PR) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.44
74049730|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.29||||0.53|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the repeated administration component (RA) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.53
74049731|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.53||||0.07|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 2 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.07
74098637|NCT00468650|147746037|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.55|0.84|<0.001
74098638|NCT00468650|147746038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|32.71|STANDARD_DEVIATION|25.36|<|0.001||95.0|27.98|37.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||37.43|27.98|<0.001
74098639|NCT00468650|147746038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|46.21|STANDARD_DEVIATION|26.27|<|0.001||95.0|41.29|51.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||51.12|41.29|<0.001
74098640|NCT00468650|147746038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.53|STANDARD_DEVIATION|26.96|<|0.001||95.0|40.44|50.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||50.63|40.44|<0.001
74098641|NCT00468650|147746038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.28|STANDARD_DEVIATION|27.01|<|0.001||95.0|40.25|50.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||50.31|40.25|<0.001
74098642|NCT00468650|147746038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.05|STANDARD_DEVIATION|27.02|<|0.001||95.0|39.99|50.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||50.11|39.99|<0.001
74098643|NCT00468650|147746039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.84|STANDARD_DEVIATION|21.1|<|0.001||95.0|9.89|17.79||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||17.79|9.89|<0.001
74098644|NCT00468650|147746039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.07|STANDARD_DEVIATION|24.25|<|0.001||95.0|8.49|17.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||17.65|8.49|<0.001
74098645|NCT00468650|147746039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.69|STANDARD_DEVIATION|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||17.23|8.14|<0.001
74098646|NCT00468650|147746039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.69|STANDARD_DEVIATION|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||17.23|8.14|<0.001
74098647|NCT00468650|147746040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.41|STANDARD_DEVIATION|4.4|<|0.001||95.0|4.59|6.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||6.23|4.59|<0.001
74098648|NCT00468650|147746040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.85|STANDARD_DEVIATION|4.96|<|0.001||95.0|7.92|9.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||9.78|7.92|<0.001
73881248|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.67||||0.01798|TWO_SIDED|95.0|0.64|11.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.20|0.64|0.01798
74018816|NCT04871711|147589953|SUPERIORITY||Risk Difference (RD)|25.7|||<|0.001|TWO_SIDED|95.0|17.2|34.3||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||34.3|17.2|<0.001
74049732|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-1.06||||0.01|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 6 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.01
74049733|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.85||||0.042|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 14 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.042
74049734|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.08||||0.89|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.89
74049735|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.34||||0.69|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.69
74049736|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.69||||0.4|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.40
74098649|NCT00468650|147746040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.21|STANDARD_DEVIATION|5.19|<|0.001||95.0|8.23|10.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||10.19|8.23|<0.001
74098650|NCT00468650|147746040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.28|STANDARD_DEVIATION|5.14|<|0.001||95.0|8.32|10.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||10.24|8.32|<0.001
74049737|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.35||||0.55|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.55
74049738|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.88||||0.32|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.32
74049739|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.37||||0.63|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.63
74049740|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.08||||0.9|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.90
74049741|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.95||||0.27|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.27
74049742|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.67||||0.42|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.42
74098651|NCT00468650|147746040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.25|STANDARD_DEVIATION|5.15|<|0.001||95.0|8.28|10.22||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||10.22|8.28|<0.001
74098652|NCT00468650|147746041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.51|STANDARD_DEVIATION|3.89|<|0.001||95.0|2.78|4.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.24|2.78|<0.001
74098653|NCT00468650|147746041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.41|<|0.001||95.0|3.08|4.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||4.74|3.08|<0.001
74098654|NCT00468650|147746041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||4.73|3.09|<0.001
74018817|NCT04871711|147589954|SUPERIORITY||Risk Difference (RD)|24.2|||<|0.001|TWO_SIDED|95.0|15.5|33.0||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||33.0|15.5|<0.001
74018818|NCT04871711|147589955|SUPERIORITY||Mean Difference (Net)|-35.2|||<|0.001|TWO_SIDED|95.0|-46.7|-23.8||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HECSI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-23.8|-46.7|<0.001
74018819|NCT04871711|147589956|SUPERIORITY||Mean Difference (Net)|-3.6|||<|0.001|TWO_SIDED|95.0|-4.7|-2.6||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline DLQI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-2.6|-4.7|<0.001
74018820|NCT04871711|147589957|SUPERIORITY||Mean Difference (Net)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.2|-1.2||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.2|-2.2|<0.001
74018821|NCT04871711|147589958|SUPERIORITY||Mean Difference (Net)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.3|-1.2||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD itch score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.2|-2.3|<0.001
74018822|NCT04871711|147589959|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-2.1|-1.0||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD pain score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.0|-2.1|<0.001
74018823|NCT04871711|147589960|SUPERIORITY||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.83|-0.45||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.45|-0.83|<0.001
74018824|NCT04871711|147589961|SUPERIORITY||Mean Difference (Net)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.79|-0.4||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS PDAL score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.40|-0.79|<0.001
74018825|NCT04871711|147589962|SUPERIORITY||Risk Difference (RD)|24.5|||<|0.001|TWO_SIDED|95.0|15.0|33.9||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||33.9|15.0|<0.001
74018826|NCT00695565|147589986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.168|TWO_SIDED|95.0|||||Mixed Models Analysis|||This analysis does not take into account the subjects' screening capsaicin response (measure of nociceptor function).||||0.168
73881249|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.19||||0.1101|TWO_SIDED|95.0|0.77|13.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||13.22|0.77|0.1101
74049743|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|1.23||||0.04|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.04
74049744|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|1.22||||0.16|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Multilevel Models|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.16
74049745|NCT04806165|147652126|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.01||||0.99|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.99
74049746|NCT04806165|147652127|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.07|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the time effect of attitudinal changes over the 14 week course of the study, regardless of the combination of components participants were assigned (ie., component turned off or on). Results will help determine whether mean participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns varied based on the time elapsed since engagement with the intervention (ie., do attitudinal changes post-inntervention endure over time?).||||<.001
74098655|NCT00468650|147746041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||4.73|3.09|<0.001
74098656|NCT00468650|147746042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.68|STANDARD_DEVIATION|4.86|<|0.001||95.0|5.77|7.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||7.59|5.77|<0.001
74098657|NCT00468650|147746042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.94|STANDARD_DEVIATION|5.21|<|0.001||95.0|8.96|10.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||10.91|8.96|<0.001
74098658|NCT00468650|147746042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.59|STANDARD_DEVIATION|5.08|<|0.001||95.0|9.62|11.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||11.56|9.62|<0.001
74098659|NCT00468650|147746042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.63|STANDARD_DEVIATION|5.03|<|0.001||95.0|9.68|11.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||11.58|9.68|<0.001
73881250|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|2.99||||0.106|TWO_SIDED|95.0|0.79|11.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.31|0.79|0.1060
74049747|NCT04806165|147652127|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.026|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the motivational interviewing (MI) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.026
74049748|NCT04806165|147652127|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.465|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the personalized recommendation (PR) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.465
74049749|NCT04806165|147652127|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.536|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the psychoeducation (PE) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.536
74049750|NCT04806165|147652127|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.049|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the repeated administration (RA) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.049
74049751|NCT02776904|147652151|OTHER|||||||0.0003||||||Adjustment with Tukey-Kramer|ANOVA|3 DF||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Memory||||0.0003
74049752|NCT02776904|147652151|OTHER|||||||0.0281||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Verbal memory||||0.0281
74049753|NCT02776904|147652151|OTHER|||||||0.0035||||||Adjusted for multiple comparisons|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Motor composite||||0.0035
74098660|NCT00468650|147746042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.64|STANDARD_DEVIATION|5.06|<|0.001||95.0|9.68|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||11.59|9.68|<0.001
74098661|NCT00468650|147746043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.29|STANDARD_DEVIATION|4.1|<|0.001||95.0|2.52|4.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.05|2.52|<0.001
74098662|NCT00468650|147746043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.03|STANDARD_DEVIATION|5.09|<|0.001||95.0|3.06|5.0||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||5.00|3.06|<0.001
74098663|NCT00468650|147746043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||4.96|3.06|<0.001
74098664|NCT00468650|147746043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||4.96|3.06|<0.001
74049754|NCT02776904|147652152|OTHER|||||||0.2637||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Reaction Time||||0.2637
74049755|NCT02776904|147652153|OTHER||||||<|0.001||||||Used Tukey's Adjustment|ANOVA|||Descriptive analysis, including means and standard deviations was used to summarize all participant data. Velocity was normalized to leg length. Normality was tested and assumed for all measured gait parameters for healthy athletes. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait velocity for healthy athletes. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance)||||<0.001
74049756|NCT02776904|147652154|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait parameters of step length. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance).|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pair wise comparisons between walk status and sex for step length.||||||< 0.0001
74049757|NCT02776904|147652155|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in DLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pairwise comparisons with p\<.05.||||||< 0.0001
74049758|NCT02776904|147652156|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in SLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for pairwise comparison between walk status and sex for %GC in SLS.||||||< 0.0001
74049759|NCT02776904|147652157|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74049760|NCT02776904|147652158|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74049761|NCT02776904|147652159|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
74049762|NCT04657003|147652161|SUPERIORITY||LSMean Mean Difference (Net)|-10.1|||<|0.001|TWO_SIDED|95.0|-11.5|-8.8|||Mixed Models Analysis|||||-8.8|-11.5|<0.001
74049763|NCT04657003|147652161|SUPERIORITY||LSMean Mean Difference (Net)|-12.4|||<|0.001|TWO_SIDED|95.0|-13.7|-11.0|||Mixed Models Analysis|||||-11.0|-13.7|<0.001
74049764|NCT04657003|147652162|SUPERIORITY||Odds Ratio (OR)|10.75|||<|0.001|TWO_SIDED|95.0|7.3|15.84|||Regression, Logistic|||||15.84|7.30|<0.001
74049765|NCT04657003|147652162|SUPERIORITY||Odds Ratio (OR)|15.28|||<|0.001|TWO_SIDED|95.0|10.08|23.14|||Regression, Logistic|||||23.14|10.08|<0.001
74049766|NCT04657003|147652163|SUPERIORITY||Odds Ratio (OR)|20.94|||<|0.001|TWO_SIDED|95.0|13.06|33.58|||Regression, Logistic|||||33.58|13.06|<0.001
74049767|NCT04657003|147652163|SUPERIORITY||Odds Ratio (OR)|27.5|||<|0.001|TWO_SIDED|95.0|17.04|44.39|||Regression, Logistic|||||44.39|17.04|<0.001
74049768|NCT04657003|147652164|SUPERIORITY||Odds Ratio (OR)|28.38|||<|0.001|TWO_SIDED|95.0|13.81|58.31|||Regression, Logistic|||||58.31|13.81|<0.001
74098665|NCT00468650|147746044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.79|STANDARD_DEVIATION|2.44|<|0.001||95.0|2.33|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.24|2.33|<0.001
74098666|NCT00468650|147746044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.23|STANDARD_DEVIATION|2.56|<|0.001||95.0|3.74|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.71|3.74|<0.001
74098667|NCT00468650|147746044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.74|STANDARD_DEVIATION|2.84|<|0.001||95.0|4.2|5.28||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||5.28|4.20|<0.001
74098668|NCT00468650|147746044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.78|STANDARD_DEVIATION|2.81|<|0.001||95.0|4.25|5.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||5.31|4.25|<0.001
74098669|NCT00468650|147746044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.76|STANDARD_DEVIATION|2.82|<|0.001||95.0|4.23|5.3||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||5.30|4.23|<0.001
74049769|NCT04657003|147652164|SUPERIORITY||Odds Ratio (OR)|43.6|||<|0.001|TWO_SIDED|95.0|21.2|89.67|||Regression, Logistic|||||89.67|21.20|<0.001
74049770|NCT04657003|147652165|SUPERIORITY||Odds Ratio (OR)|28.54|||<|0.001|TWO_SIDED|95.0|9.73|83.73|||Regression, Logistic|||||83.73|9.73|<0.001
74049771|NCT04657003|147652165|SUPERIORITY||Odds Ratio (OR)|49.68|||<|0.001|TWO_SIDED|95.0|17.03|144.94|||Regression, Logistic|||||144.94|17.03|<0.001
74049772|NCT04657003|147652166|SUPERIORITY||LSMean Mean Difference (Net)|-10.3|||<|0.001|TWO_SIDED|95.0|-11.7|-8.8|||Mixed Models Analysis|||||-8.8|-11.7|<0.001
74098670|NCT00468650|147746045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.49|STANDARD_DEVIATION|1.91|<|0.001||95.0|1.13|1.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.85|1.13|<0.001
74049773|NCT04657003|147652166|SUPERIORITY||LSMean Mean Difference (Net)|-12.4|||<|0.001|TWO_SIDED|95.0|-13.8|-11.0|||Mixed Models Analysis|||||-11.0|-13.8|<0.001
74049774|NCT04657003|147652167|SUPERIORITY||LSMean Mean Difference (Net)|-3.7|||<|0.001|TWO_SIDED|95.0|-4.2|-3.2|||Mixed Models Analysis|||||-3.2|-4.2|<0.001
74049775|NCT04657003|147652167|SUPERIORITY||LSMean Mean Difference (Net)|-4.5|||<|0.001|TWO_SIDED|95.0|-5.0|-4.0|||Mixed Models Analysis|||||-4.0|-5.0|<0.001
74049776|NCT04657003|147652168|SUPERIORITY||LSMean Mean Difference (Net)|-1.97|||<|0.001|TWO_SIDED|95.0|-2.15|-1.8|||Mixed Models Analysis|||||-1.80|-2.15|<0.001
74049777|NCT04657003|147652168|SUPERIORITY||LSMean Mean Difference (Net)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.24|-1.88|||Mixed Models Analysis|||||-1.88|-2.24|<0.001
74049778|NCT04657003|147652169|SUPERIORITY||Odds Ratio (OR)|28.01|||<|0.001|TWO_SIDED|95.0|17.21|45.59|||Regression, Logistic|||||45.59|17.21|<0.001
74049779|NCT04657003|147652169|SUPERIORITY||Odds Ratio (OR)|34.19|||<|0.001|TWO_SIDED|95.0|20.27|57.67|||Regression, Logistic|||||57.67|20.27|<0.001
74049780|NCT04657003|147652170|SUPERIORITY||Odds Ratio (OR)|42.11|||<|0.001|TWO_SIDED|95.0|25.61|69.26|||Regression, Logistic|||||69.26|25.61|<0.001
74049781|NCT04657003|147652170|SUPERIORITY||Odds Ratio (OR)|58.67|||<|0.001|TWO_SIDED|95.0|34.29|100.37|||Regression, Logistic|||||100.37|34.29|<0.001
74049782|NCT04657003|147652171|SUPERIORITY||Odds Ratio (OR)|42.55|||<|0.001|TWO_SIDED|95.0|20.46|88.5|||Regression, Logistic|||||88.50|20.46|<0.001
74049783|NCT04657003|147652171|SUPERIORITY||Odds Ratio (OR)|54.3|||<|0.001|TWO_SIDED|95.0|26.0|113.38|||Regression, Logistic|||||113.38|26.00|<0.001
74049784|NCT04657003|147652172|SUPERIORITY||LSMean Mean Difference (Net)|-46.79|||<|0.001|TWO_SIDED|95.0|-52.67|-40.91|||Mixed Models Analysis|||||-40.91|-52.67|<0.001
74049785|NCT04657003|147652172|SUPERIORITY||LSMean Mean Difference (Net)|-49.25|||<|0.001|TWO_SIDED|95.0|-55.18|-43.33|||Mixed Models Analysis|||||-43.33|-55.18|<0.001
74049786|NCT04657003|147652173|SUPERIORITY||LSMean Mean Difference (Net)|-7.8|||<|0.001|TWO_SIDED|95.0|-9.2|-6.4|||Mixed Models Analysis|||||-6.4|-9.2|<0.001
74049787|NCT04657003|147652173|SUPERIORITY||LSMean Mean Difference (Net)|-10.4|||<|0.001|TWO_SIDED|95.0|-11.8|-8.9|||Mixed Models Analysis|||||-8.9|-11.8|<0.001
74049788|NCT04657003|147652174|SUPERIORITY||Estimate Difference|-4.61|||<|0.001|TWO_SIDED|95.0|-7.11|-2.03|||Mixed Models Analysis|||||-2.03|-7.11|<0.001
74098671|NCT00468650|147746045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.96|STANDARD_DEVIATION|2.08|<|0.001||95.0|1.57|2.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||2.36|1.57|<0.001
74098672|NCT00468650|147746045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.98|STANDARD_DEVIATION|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||2.37|1.59|<0.001
74098673|NCT00468650|147746045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.98|STANDARD_DEVIATION|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||2.37|1.59|<0.001
74098674|NCT00468650|147746046|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|8.84|STANDARD_DEVIATION|28.7||0.0016||95.0|3.42|14.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||14.26|3.42|0.0016
74049789|NCT04657003|147652175|SUPERIORITY||Estimate Difference|-3.36||||0.112|TWO_SIDED|95.0|-7.36|0.81|||Mixed Models Analysis|||||0.81|-7.36|0.112
74049790|NCT04657003|147652176|SUPERIORITY||Estimate Difference|7.02|||<|0.001|TWO_SIDED|95.0|4.4|9.71|||Mixed Models Analysis|||||9.71|4.40|<0.001
74049791|NCT04657003|147652177|SUPERIORITY||Estimate Difference|-23.3|||<|0.001|TWO_SIDED|95.0|-27.5|-18.9|||Mixed Models Analysis|||||-18.9|-27.5|<0.001
74049792|NCT04657003|147652178|SUPERIORITY||Estimate Difference|-24.2|||<|0.001|TWO_SIDED|95.0|-28.6|-19.6|||Mixed Models Analysis|||||-19.6|-28.6|<0.001
74049793|NCT04657003|147652179|SUPERIORITY||Estimate Difference|-8.74|||<|0.001|TWO_SIDED|95.0|-12.04|-5.32|||Mixed Models Analysis|||||-5.32|-12.04|<0.001
74049794|NCT04657003|147652180|SUPERIORITY||Estimate Difference|-23.61|||<|0.001|TWO_SIDED|95.0|-28.62|-18.24|||Mixed Models Analysis|||||-18.24|-28.62|<0.001
74049795|NCT04657003|147652181|SUPERIORITY||LSMean Mean Difference (Net)|-6.2|||<|0.001|TWO_SIDED|95.0|-8.0|-4.4|||Mixed Models Analysis|||||-4.4|-8.0|<0.001
74098675|NCT00468650|147746046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.18|STANDARD_DEVIATION|27.51|<|0.001||95.0|4.93|15.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||15.43|4.93|<0.001
74098676|NCT00468650|147746046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.29|STANDARD_DEVIATION|28.88|<|0.001||95.0|6.7|17.88||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||17.88|6.70|<0.001
74098677|NCT00468650|147746046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.96|STANDARD_DEVIATION|28.33|<|0.001||95.0|6.61|17.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||17.32|6.61|<0.001
74049796|NCT04657003|147652182|SUPERIORITY||LSMean Mean Difference (Net)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.5|-1.3|||Mixed Models Analysis|||||-1.3|-3.5|<0.001
74049797|NCT04657003|147652183|SUPERIORITY||Estimate Difference|-17.6|||<|0.001|TWO_SIDED|95.0|-25.5|-8.9|||Mixed Models Analysis|||||-8.9|-25.5|<0.001
74049798|NCT04657003|147652183|SUPERIORITY||Estimate Difference|-30.2|||<|0.001|TWO_SIDED|95.0|-37.0|-22.7|||Mixed Models Analysis|||||-22.7|-37.0|<0.001
74049799|NCT04657003|147652184|SUPERIORITY||LSMean Mean Difference (Net)|1.8||||0.001|TWO_SIDED|95.0|0.7|2.9|||ANCOVA|||||2.9|0.7|0.001
74049800|NCT04657003|147652184|SUPERIORITY||LSMean Mean Difference (Net)|2.3|||<|0.001|TWO_SIDED|95.0|1.1|3.4|||ANCOVA|||||3.4|1.1|<0.001
74049801|NCT04657003|147652185|SUPERIORITY||LSMean Difference (Net)|6.9|||<|0.001|TWO_SIDED|95.0|4.1|9.7|||ANCOVA|||||9.7|4.1|<0.001
74049802|NCT04657003|147652185|SUPERIORITY||LSMean Difference (Net)|7.8|||<|0.001|TWO_SIDED|95.0|5.0|10.7|||ANCOVA|||||10.7|5.0|<0.001
74049803|NCT01736176|147652187|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.||The primary null hypothesis was no change in least-square (LS) mean, calculated using a mixed-effect repeated measures model (MMRM), for NMSS total score from baseline to Week 12. The statistical test was two-sided and the null hypothesis was rejected at the significance level of α = 0.050.||||< 0.001
74049804|NCT01736176|147652191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.||||||0.004
74049805|NCT01599585|147652249|NON_INFERIORITY_OR_EQUIVALENCE|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.4|||||TWO_SIDED|90.0|0.12|0.68||||||||.68|.12|
74049806|NCT01599585|147652261|NON_INFERIORITY_OR_EQUIVALENCE|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.47|||||TWO_SIDED|90.0|0.16|0.78||||||||.78|.16|
74049807|NCT01948518|147652274|SUPERIORITY_OR_OTHER||||||=|0.3|TWO_SIDED||||||t-test, 2 sided|||Assuming 15% change in absolute value of DLCO representing a significant clinical difference and a standard deviation of 17.4% in normal nonsmoking individuals \[Miller A, Thornton JC, Warshaw R, et al. Am Rev Respir Dis. 1983;127 (suppl 3):270-277.\], 13 subjects needed to be studied to reject the null hypothesis when there is no significant difference between DLCO measurements before and after sildenafil, with power 0.8 and type I error probability 0.05 (SAS 9.2, SAS Institute Inc., Cary, NC)||||=0.30
74049808|NCT01948518|147652275|SUPERIORITY_OR_OTHER||||||=|0.63|||||||t-test, 2 sided|||The average 6 minute walk distance at baseline was 1195±407 feet. After oral administration of sildenafil, 6 minute walk distance was 1214±383 feet (p=0.63).||||=0.63
74049809|NCT00598806|147652276|SUPERIORITY||Odds Ratio (OR)|0.76||||0.1094|TWO_SIDED|95.0|0.55|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.55|0.1094
74049810|NCT00598806|147652277|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1038|TWO_SIDED|95.0|0.63|1.04|||Log Rank|||||1.04|0.63|0.1038
74049811|NCT01714336|147652355|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Regression, Logistic|||||||0.75
74049812|NCT01766401|147652368|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.0438|TWO_SIDED|95.0|-2.96|-0.04|||MMRM|||||-0.04|-2.96|0.0438
74049813|NCT01766401|147652369|SUPERIORITY||Least Squares Mean Difference|-1.41||||0.0868|TWO_SIDED|95.0|-3.02|0.2|||MMRM|||||0.20|-3.02|0.0868
74049814|NCT01523613|147652370|SUPERIORITY|||||||0.262|||||||Fisher Exact|||||||0.262
74049815|NCT01523613|147652371|SUPERIORITY|||||||0.523|||||||Fisher Exact|||||||0.523
74049816|NCT01523613|147652372|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.100
74049817|NCT01021553|147652375|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.16||||0.4959|TWO_SIDED|95.0|0.75|1.79|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.79|0.75|0.4959
74049818|NCT01021553|147652375|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.11||||0.6161|TWO_SIDED|95.0|0.74|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.65|0.74|0.6161
74049819|NCT01021553|147652375|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.13||||0.4971|TWO_SIDED|95.0|0.79|1.61|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.61|0.79|0.4971
74049820|NCT01021553|147652376|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.03||||0.9037|TWO_SIDED|95.0|0.67|1.58|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4||1.58|0.67|0.9037
74049821|NCT01021553|147652376|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.0||||0.9939|TWO_SIDED|95.0|0.67|1.48|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4||1.48|0.67|0.9939
74049822|NCT01021553|147652376|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.01||||0.9541|TWO_SIDED|95.0|0.71|1.43|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 0-4||1.43|0.71|0.9541
74049823|NCT01021553|147652376|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.33||||0.2798|TWO_SIDED|95.0|0.79|2.24|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||2.24|0.79|0.2798
74049824|NCT01021553|147652376|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.09||||0.7255|TWO_SIDED|95.0|0.68|1.75|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||1.75|0.68|0.7255
74049825|NCT01021553|147652376|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.18||||0.4347|TWO_SIDED|95.0|0.77|1.8|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||1.80|0.77|0.4347
74049826|NCT01021553|147652377|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.14||||0.6583|TWO_SIDED|95.0|0.63|2.05|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||2.05|0.63|0.6583
74049827|NCT01021553|147652377|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|0.96||||0.879|TWO_SIDED|95.0|0.56|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.65|0.56|0.8790
74049828|NCT01021553|147652377|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.03||||0.8971|TWO_SIDED|95.0|0.64|1.67|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.67|0.64|0.8971
74049829|NCT01021553|147652380|SUPERIORITY_OR_OTHER||Ratio of treatments|2.91|||||TWO_SIDED|90.0|2.43|3.48|||||For AUC (0-inf)|||3.48|2.43|
74049830|NCT01021553|147652380|SUPERIORITY_OR_OTHER||Ratio of treatments|2.98|||||TWO_SIDED|90.0|2.51|3.54||||||||3.54|2.51|
74049831|NCT01021553|147652381|SUPERIORITY_OR_OTHER||Ratio of treatments|3.63|||||TWO_SIDED|90.0|2.95|4.47||||||||4.47|2.95|
74049832|NCT00033293|147652437|OTHER||Chi-squared test statistic|8.125||||0.0044|TWO_SIDED|95.0||||No adjustments for multiple comparisons.|Chi-squared|A two-way test with a null hypothesis of no association, using SAS 9.4.||"The 5 categories of OMA ratings are: stance, gait, arm \& hand function, opsoclonus, \& mood/behavior. For each category, a patient's response will be based on a comparison of the baseline evaluation to the best of 3 time points: 2 months, 6 months \& 1 year. If a patient crosses over to the IVIG arm or switches to ACTH at any time, the patient will be considered a non-responder. The proportion of responders from the 2 treatment arms were compared using a chi-squared test."||||0.0044
74049833|NCT00033293|147652438|OTHER||Mean Difference (Net)|60.1979||||0.0919|ONE_SIDED||||||t-test, 1 sided|||The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.||||0.0919
74049834|NCT00033293|147652439|OTHER|The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.|Mean Difference (Net)|16.75||||0.2364|ONE_SIDED||||||t-test, 1 sided|||||||0.2364
74049835|NCT00935701|147652445|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Restless-Impulsive subscale||||0.01
74049836|NCT00935701|147652445|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Emotional Lability subscale||||0.09
74049837|NCT00935701|147652445|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Global Index Total||||0.02
74049838|NCT00935701|147652445|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Inattentive subscale||||0.01
74049839|NCT00935701|147652445|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Hyperactive-Impulsive subscale||||0.03
74049840|NCT00935701|147652445|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Total||||0.01
74049841|NCT00935701|147652446|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Bedtime Resistance subscale||||0.08
74049842|NCT00935701|147652446|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Onset Delay subscale||||0.03
74049843|NCT00935701|147652446|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Duration subscale||||0.82
74049844|NCT00935701|147652446|SUPERIORITY_OR_OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Anxiety subscale||||0.58
74018827|NCT00695565|147589986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.014|TWO_SIDED|95.0|||||Mixed Models Analysis|||"Each subject was screened for responsiveness of nociceptors in the skin to a capsaicin stimulus (rated on 0-10 pain scale; 0=no pain and 10=worst possible pain). The interaction term composed of treatment assignment and capsaicin threshold was examined at the prespecified alpha level of 0.1.~This analysis includes subjects with a capsaicin rating of ≥ 2. Thirty (30) subjects in the Placebo group and 33 subjects in the active Clonidine Topical Gel (ARC-4558) group had capsaicin scores ≥ 2."||||0.014
74049845|NCT00935701|147652446|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Night Wakings subscale||||0.66
74049846|NCT00935701|147652446|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parasomnias subscale||||0.18
74049847|NCT00935701|147652446|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Daytime Sleepiness subscale||||0.31
74018828|NCT02288273|147590000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
74018829|NCT02419508|147590007|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
74018830|NCT02419508|147590008|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74018831|NCT02419508|147590009|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74018832|NCT02419508|147590010|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74018833|NCT02419508|147590011|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74018834|NCT02419508|147590012|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74018835|NCT02419508|147590013|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74018836|NCT00445302|147590020|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|87.09|||||TWO_SIDED|90.0|63.59|119.26||||||||119.26|63.59|
74018837|NCT00445302|147590020|SUPERIORITY_OR_OTHER||Ratio of least squares means(%)|106.6||||||90.0|78.99|143.87||||||||143.87|78.99|
74018838|NCT00445302|147590020|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|106.76||||||90.0|79.11|144.08||||||||144.08|79.11|
74018839|NCT00445302|147590023|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|121.74||||||90.0|91.86|161.43||||||||161.43|91.86|
74018840|NCT00445302|147590023|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|151.44||||||90.0|115.78|198.09||||||||198.09|115.78|
74018841|NCT00445302|147590023|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|169.51||||||90.0|129.59|221.72||||||||221.72|129.59|
74018842|NCT03216382|147590059|SUPERIORITY|||||||0.93||||||The apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.93
74018843|NCT03216382|147590060|SUPERIORITY|||||||0.74||||||this value represents the interaction between condition and the intervention time period The apriori threshold for significance was a = 0.05.|Mixed Models Analysis|||HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry||||.74
74018844|NCT03216382|147590060|SUPERIORITY|||||||0.44||||||this value represents the interaction between condition and the intervention time period (squared) The apriori threshold for significance was a = 0.05.|Mixed Models Analysis|||HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry||||.44
74018845|NCT03216382|147590061|SUPERIORITY|||||||0.17||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.17
74018846|NCT03216382|147590062|SUPERIORITY|||||||0.5||||||The apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time .|Mixed Models Analysis|||HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention||||.50
74018847|NCT03216382|147590062|SUPERIORITY|||||||0.02||||||The apriori threshold for significance was a= 0.05. The p value reflects the test of an interaction between condition and intervention period (days 7-14, squared).|Mixed Models Analysis|||HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention||||.02
74049848|NCT00935701|147652446|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Disturbance||||0.07
74049849|NCT00935701|147652447|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Child Domain Total||||0.04
74049850|NCT00935701|147652447|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parent Domain Total||||0.31
74049851|NCT00935701|147652447|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Stress||||0.07
74049852|NCT01700140|147652448|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
74049853|NCT01700140|147652448|SUPERIORITY_OR_OTHER|||||||0.2284|||||||Fisher Exact|||||||0.2284
74049854|NCT01700140|147652448|SUPERIORITY_OR_OTHER|||||||0.2549|||||||Cochran-Armitage test|||||||0.2549
74049855|NCT01700140|147652449|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
74049856|NCT01700140|147652449|SUPERIORITY_OR_OTHER|||||||0.1527|||||||Fisher Exact|||||||0.1527
74049857|NCT01700140|147652449|SUPERIORITY_OR_OTHER|||||||0.1864|||||||Cochran-Armitage test|||||||0.1864
74049858|NCT01700140|147652450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.918||||0.8361|TWO_SIDED|95.0|0.266|3.172|||Generalized Wilcoxon test|||||3.172|0.266|0.8361
74049859|NCT01700140|147652450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.423||||0.0724|TWO_SIDED|95.0|0.144|1.237|||Generalized Wilcoxon test|||||1.237|0.144|0.0724
74049860|NCT01700140|147652451|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213||||0.6466|TWO_SIDED|95.0|0.616|2.388|||Generalized Wilcoxon test|||||2.388|0.616|0.6466
73881251|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.47||||0.5258|TWO_SIDED|95.0|0.45|4.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.86|0.45|0.5258
73881252|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8746|TWO_SIDED|95.0|0.34|3.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.50|0.34|0.8746
73881253|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7434|TWO_SIDED|95.0|0.24|2.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.77|0.24|0.7434
74018848|NCT03216382|147590063|SUPERIORITY|||||||0.46||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.46
74018849|NCT03216382|147590064|SUPERIORITY|||||||0.53||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.53
74049861|NCT01700140|147652451|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.828||||0.2701|TWO_SIDED|95.0|0.566|1.21|||Generalized Wilcoxon test|||||1.210|0.566|0.2701
74049862|NCT01700140|147652452|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation||||1.0000
74049863|NCT01700140|147652452|SUPERIORITY_OR_OTHER|||||||0.1051|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation||||0.1051
74049864|NCT01700140|147652452|SUPERIORITY_OR_OTHER|||||||0.4856|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation||||0.4856
74049865|NCT01700140|147652452|SUPERIORITY_OR_OTHER|||||||0.1047|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation||||0.1047
74049866|NCT01700140|147652452|SUPERIORITY_OR_OTHER|||||||0.1617|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation||||0.1617
74049867|NCT01700140|147652452|SUPERIORITY_OR_OTHER|||||||0.3099|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation||||0.3099
74049868|NCT01700140|147652453|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation||||1.0000
74049869|NCT01700140|147652453|SUPERIORITY_OR_OTHER|||||||0.1051|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation||||0.1051
74049870|NCT01700140|147652453|SUPERIORITY_OR_OTHER|||||||0.6761|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation||||0.6761
74049871|NCT01700140|147652453|SUPERIORITY_OR_OTHER|||||||0.3513|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation||||0.3513
74049872|NCT01700140|147652453|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation||||0.2060
74049873|NCT01700140|147652453|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation||||0.0511
74049874|NCT00542425|147652457|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.||||<0.001
74049875|NCT00542425|147652457|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.||||<0.001
74049876|NCT00542425|147652458|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.||||<0.001
74018850|NCT03216382|147590065|SUPERIORITY|||||||0.07||||||the apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.07
74018851|NCT03216382|147590066|SUPERIORITY|||||||0.58||||||the apriori threshold for significance was 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.58
74049877|NCT00542425|147652458|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.||||<0.001
74049878|NCT01610414|147652462|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) for overall HZ vaccine efficacy was above 0%.|Vaccine efficacy|68.17|||<|0.0001|TWO_SIDED|95.0|55.56|77.53|||Poisson method|||Vaccine efficacy (VE) was evaluated in the prevention of Herpes Zoster (HZ) in autologous haematopoietic stem cell transplant (HCT) recipients 18 years of agee and older.||77.53|55.56|<0.0001
74049879|NCT00286156|147652559|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Pairwise comparisons adjusted for multiple testing (Tukey)|ANOVA|||Null hypothesis: no difference between groups in iGFR||||<0.01
74049880|NCT05325333|147652564|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at 5 mins for children with DLD||||||0.567|||||||LSD test|||||||0.567
74049881|NCT05325333|147652564|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at 5 mins for children with TD||||||0.003|||||||LSD test|||||||0.003
73881254|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.9||||0.3211|TWO_SIDED|95.0|0.53|6.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.80|0.53|0.3211
73881255|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.51||||0.533|TWO_SIDED|95.0|0.41|5.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.48|0.41|0.5330
73881256|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|3.0||||0.1119|TWO_SIDED|95.0|0.77|11.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||11.64|0.77|0.1119
73881257|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.76||||0.354|TWO_SIDED|95.0|0.53|5.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.85|0.53|0.3540
73881258|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|0.65||||0.5076|TWO_SIDED|95.0|0.19|2.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.29|0.19|0.5076
74049882|NCT05325333|147652565|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at one week for children with DLD||||||0.187|||||||LSD test|||||||0.187
74098678|NCT00468650|147746046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.95|STANDARD_DEVIATION|28.55|<|0.001||95.0|6.51|17.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||17.40|6.51|<0.001
74098679|NCT00468650|147746047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.37|STANDARD_DEVIATION|14.85||0.3324||95.0|-1.42|4.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.17|-1.42|0.3324
74049883|NCT05325333|147652565|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at one week for children with TD||||||0.256|||||||LSD test|||||||0.256
74049884|NCT05325333|147652566|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at 5 Mins for DLD||||||0.747|||||||LSD test|||||||0.747
74098680|NCT00468650|147746047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.12|STANDARD_DEVIATION|14.26||0.0249||95.0|0.4|5.84||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||5.84|0.40|0.0249
74098681|NCT00468650|147746047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.98|STANDARD_DEVIATION|13.95||0.0249||95.0|0.37|5.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||5.58|0.37|0.0249
74098682|NCT00468650|147746047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.04|STANDARD_DEVIATION|14.07||0.0249||95.0|0.39|5.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||5.68|0.39|0.0249
73881259|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|0.71||||0.5801|TWO_SIDED|95.0|0.21|2.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.41|0.21|0.5801
73881260|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2785|TWO_SIDED|95.0|0.13|1.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.82|0.13|0.2785
73881261|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5656|TWO_SIDED|95.0|0.19|2.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.45|0.19|0.5656
73881262|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6445|TWO_SIDED|95.0|0.19|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.81|0.19|0.6445
74098683|NCT00468650|147746048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.37|STANDARD_DEVIATION|30.51|<|0.001||95.0|9.38|21.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||21.36|9.38|<0.001
73888116|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|34.8||||0.2161|TWO_SIDED|95.0|-20.6|90.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.1|-20.6|0.2161
74049885|NCT05325333|147652566|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at 5 Mins for TD||||||0.031|||||||LSD test|||||||0.031
74098684|NCT00468650|147746048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.15|STANDARD_DEVIATION|32.22|<|0.001||95.0|10.76|23.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||23.55|10.76|<0.001
74098685|NCT00468650|147746048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.22|STANDARD_DEVIATION|32.44|<|0.001||95.0|11.68|24.76||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||24.76|11.68|<0.001
74098686|NCT00468650|147746048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.33|STANDARD_DEVIATION|31.87|<|0.001||95.0|11.07|23.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||23.59|11.07|<0.001
74098687|NCT00468650|147746048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.68|STANDARD_DEVIATION|32.1|<|0.001||95.0|11.31|24.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||24.04|11.31|<0.001
74098688|NCT00468650|147746049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.46|STANDARD_DEVIATION|9.41||0.1061||95.0|-0.32|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||3.24|-0.32|0.1061
74098689|NCT00468650|147746049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.18|STANDARD_DEVIATION|12.33||0.3237||95.0|-1.18|3.54||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||3.54|-1.18|0.3237
74098690|NCT00468650|147746049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.13|STANDARD_DEVIATION|12.05||0.3236||95.0|-1.13|3.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||3.38|-1.13|0.3236
74098691|NCT00468650|147746049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.15|STANDARD_DEVIATION|12.16||0.3236||95.0|-1.15|3.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||3.45|-1.15|0.3236
74098692|NCT00468650|147746050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|56.96|STANDARD_DEVIATION|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||64.60|49.31|<0.001
74098693|NCT00468650|147746050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.78|STANDARD_DEVIATION|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||77.81|63.74|<0.001
74098694|NCT00468650|147746050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.23|STANDARD_DEVIATION|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.45|64.02|<0.001
74098695|NCT00468650|147746050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.15|STANDARD_DEVIATION|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.11|65.20|<0.001
74098696|NCT00468650|147746050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.6|STANDARD_DEVIATION|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||78.65|64.54|<0.001
74098697|NCT00468650|147746051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.56|STANDARD_DEVIATION|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||19.40|7.72|<0.001
74098698|NCT00468650|147746051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.25|STANDARD_DEVIATION|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.25|8.25|<0.001
74098699|NCT00468650|147746051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.51|STANDARD_DEVIATION|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||20.46|8.56|<0.001
73881263|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|1.27||||0.7363|TWO_SIDED|95.0|0.32|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.99|0.32|0.7363
74098700|NCT00468650|147746051|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.77|STANDARD_DEVIATION|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||20.82|8.72|<0.001
74098701|NCT00468650|147746052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|58.58|STANDARD_DEVIATION|41.24|<|0.001||95.0|50.48|66.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||66.68|50.48|<0.001
74098702|NCT00468650|147746052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|76.29|STANDARD_DEVIATION|37.21|<|0.001||95.0|68.9|83.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||83.67|68.90|<0.001
74098703|NCT00468650|147746052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|77.69|STANDARD_DEVIATION|37.26|<|0.001||95.0|70.18|85.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||85.21|70.18|<0.001
74098704|NCT00468650|147746052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|78.79|STANDARD_DEVIATION|36.65|<|0.001||95.0|71.59|85.99||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||85.99|71.59|<0.001
74049886|NCT05325333|147652567|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at one week for DLD||||||0.061|||||||LSD test|||||||0.061
74049887|NCT05325333|147652567|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at one week for TD||||||0.747|||||||LSD test|||||||0.747
73881264|NCT03192176|147297630|SUPERIORITY||Odds Ratio (OR)|0.56||||0.3455|TWO_SIDED|95.0|0.17|1.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.86|0.17|0.3455
74049888|NCT05325333|147652568|SUPERIORITY|Word recognition (number of words accurately identified) on Expanding condition and Standard Retrieval Schedules for DLD||||||0.026|||||||LSD test|||||||0.026
74049889|NCT05325333|147652568|SUPERIORITY|Word recognition (number of words accurately identified) on Expanding condition and Standard Retrieval Schedules for TD||||||0.72|||||||LSD test|||||||0.720
74049890|NCT05325333|147652569|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
74049891|NCT05325333|147652570|SUPERIORITY|||||||0.673|||||||t-test, 2 sided|||||||0.673
74049892|NCT00290355|147652571|OTHER||Hazard Ratio (HR)|0.74||||0.256|TWO_SIDED|95.0|0.44|1.24||Two-sided p value from Cox regression model adjusted for covariate(s) node/squam/stage to test the null hypothesis was: the distribution of time to recurrences was the same in each group (H0 = \[HR=1\]).|Regression, Cox|The p value by log rank test was 0.1995. Criterion for evaluation of the objective: one sided p-value \< 10%||Hazard ratio of GSK 249553 study product.||1.24|0.44|0.256
74049893|NCT03502941|147652596|SUPERIORITY||||||<|0.05||||||P value was calculated.|t-test, 2 sided|||||||<0.05
74049894|NCT03502941|147652597|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74049895|NCT03442595|147652684|OTHER|test of difference in change of A1C between the two groups|||||<|0.001|||||||t-test, 2 sided|||The study was powered to detect a difference of 0.5% in the change in A1C with SD = 2 with 80\& at alopha = 0.;05 with a sample size of 128 in each group (paired t-test). The study reaches 100% power to detect this observed difference with an alpha level of 0.01.||||<0.001
74049896|NCT00170846|147652691|SUPERIORITY_OR_OTHER||Difference in LS means|1.1241||||0.6332|TWO_SIDED|95.0|-3.5077|5.7559|||ANCOVA|||||5.7559|-3.5077|0.6332
74049897|NCT00170846|147652691|SUPERIORITY_OR_OTHER||Difference in LS means|0.5933||||0.7943|TWO_SIDED|95.0|-3.8815|5.0682|||ANCOVA|||||5.0682|-3.8815|0.7943
74049898|NCT02607865|147652694|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.6|< 0.0001
74049899|NCT02607865|147652694|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.6|< 0.0001
74049900|NCT02607865|147652694|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.2|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.4|< 0.0001
74049901|NCT02607865|147652694|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.4|< 0.0001
73881265|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0037|TWO_SIDED|95.0|1.6|11.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||11.54|1.60|0.0037
73881266|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|3.95||||0.0057|TWO_SIDED|95.0|1.49|10.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||10.48|1.49|0.0057
73881267|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0003|TWO_SIDED|95.0|2.26|16.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.13|2.26|0.0003
73881268|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0003|TWO_SIDED|95.0|2.37|17.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.39|2.37|0.0003
74018852|NCT03216382|147590067|SUPERIORITY|||||||0.86||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.86
74018853|NCT03216382|147590068|SUPERIORITY|||||||0.39||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.39
74018854|NCT01337973|147590076|SUPERIORITY||Coefficient estimate|0.82|||<|0.001|TWO_SIDED|95.0|0.37|1.84||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z value: -4.65|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||1.84|0.37|<0.001
74018855|NCT01337973|147590076|SUPERIORITY||Coefficient Estimate|0.62|||<|0.01|TWO_SIDED|95.0|0.3|1.29||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.83|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline||1.29|0.30|<0.01
74018856|NCT01337973|147590076|SUPERIORITY||Coefficient Estimate|1.16|||<|0.01|TWO_SIDED|95.0|0.36|3.77||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.31|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||3.77|0.36|<0.01
73881269|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.11||||0.141|TWO_SIDED|95.0|0.78|5.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.73|0.78|0.1410
73881270|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|5.85||||0.0004|TWO_SIDED|95.0|2.2|15.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||15.55|2.20|0.0004
73881271|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|5.5||||0.0006|TWO_SIDED|95.0|2.08|14.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.54|2.08|0.0006
73881272|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|4.09||||0.0037|TWO_SIDED|95.0|1.58|10.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.57|1.58|0.0037
74018857|NCT01337973|147590076|SUPERIORITY||Coefficient Estimate|0.51|||<|0.05|TWO_SIDED|95.0|0.19|1.38||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.26|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||1.38|0.19|<0.05
74018858|NCT01337973|147590076|SUPERIORITY||Coefficient Estimate|1.22|||<|0.001|TWO_SIDED|95.0|0.66|2.28||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.79|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||2.28|0.66|<0.001
74049902|NCT02607865|147652694|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|0.2|||=|0.0856|TWO_SIDED|95.0|0.1|0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.3|0.1|= 0.0856
74049903|NCT02607865|147652694|SUPERIORITY|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|0.2|||=|0.008|TWO_SIDED|95.0|0.0|0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.3|0.0|= 0.0080
74049904|NCT02607865|147652694|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.7|<0.0001
74049905|NCT02607865|147652694|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.7|<0.0001
74049906|NCT02607865|147652694|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-0.4|<0.0001
74098705|NCT00468650|147746052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|78.36|STANDARD_DEVIATION|36.89|<|0.001||95.0|71.04|85.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||85.68|71.04|<0.001
74098706|NCT00468650|147746053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.9|STANDARD_DEVIATION|36.63|<|0.001||95.0|10.98|24.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||24.83|10.98|<0.001
74098707|NCT00468650|147746053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.5|STANDARD_DEVIATION|36.84|<|0.001||95.0|12.44|26.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||26.56|12.44|<0.001
74098708|NCT00468650|147746053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.52|STANDARD_DEVIATION|36.99|<|0.001||95.0|12.59|26.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||26.45|12.59|<0.001
74098709|NCT00468650|147746053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.88|STANDARD_DEVIATION|37.23|<|0.001||95.0|12.84|26.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||26.91|12.84|<0.001
74098710|NCT00468650|147746054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|57.34|STANDARD_DEVIATION|42.6|<|0.001||95.0|48.93|65.75||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||65.75|48.93|<0.001
73881273|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0026|TWO_SIDED|95.0|1.67|11.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.16|1.67|0.0026
73881274|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|6.26||||0.0002|TWO_SIDED|95.0|2.63|16.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.60|2.63|0.0002
74049907|NCT02607865|147652694|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-0.4|<0.0001
74098711|NCT00468650|147746054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.72|STANDARD_DEVIATION|40.3|<|0.001||95.0|62.72|78.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||78.71|62.72|<0.001
74098712|NCT00468650|147746054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.63|STANDARD_DEVIATION|40.78|<|0.001||95.0|62.41|78.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.85|62.41|<0.001
74098713|NCT00468650|147746054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.07|STANDARD_DEVIATION|40.27|<|0.001||95.0|64.16|79.98||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.98|64.16|<0.001
74098714|NCT00468650|147746054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.51|STANDARD_DEVIATION|40.48|<|0.001||95.0|63.48|79.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||79.55|63.48|<0.001
74098715|NCT00468650|147746055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.1|STANDARD_DEVIATION|29.11|<|0.001||95.0|7.58|18.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||18.63|7.58|<0.001
74098716|NCT00468650|147746055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.11|STANDARD_DEVIATION|32.53|<|0.001||95.0|7.84|20.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.37|7.84|<0.001
74098717|NCT00468650|147746055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.47|STANDARD_DEVIATION|31.92|<|0.001||95.0|7.47|19.47||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||19.47|7.47|<0.001
74098718|NCT00468650|147746055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.72|STANDARD_DEVIATION|32.16|<|0.001||95.0|7.61|19.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||19.82|7.61|<0.001
74098719|NCT00468650|147746056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|56.96|STANDARD_DEVIATION|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||64.60|49.31|<0.001
74098720|NCT00468650|147746056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.78|STANDARD_DEVIATION|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||77.81|63.74|<0.001
74098721|NCT00468650|147746056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.23|STANDARD_DEVIATION|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.45|64.02|<0.001
74098722|NCT00468650|147746056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.15|STANDARD_DEVIATION|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.11|65.20|<0.001
73881275|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|9.4|||<|0.0001|TWO_SIDED|95.0|3.23|27.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||27.34|3.23|<0.0001
73888117|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9||||0.8905|TWO_SIDED|95.0|-51.5|59.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.2|-51.5|0.8905
74098723|NCT00468650|147746056|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.6|STANDARD_DEVIATION|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||78.65|64.54|<0.001
74098724|NCT00468650|147746057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.56|STANDARD_DEVIATION|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||19.40|7.72|<0.001
74098725|NCT00468650|147746057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.25|STANDARD_DEVIATION|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.25|8.25|<0.001
74049908|NCT02607865|147652694|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||=|0.3851|TWO_SIDED|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.4|0.1|=0.3851
74049909|NCT02607865|147652694|OTHER|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.4|0.1|<0.0001
74049910|NCT02607865|147652695|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.0|-2.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-2.0|-3.0|< 0.0001
74049911|NCT02607865|147652695|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.1|-2.0|< 0.0001
74098726|NCT00468650|147746057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.51|STANDARD_DEVIATION|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||20.46|8.56|<0.001
74098727|NCT00468650|147746057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.77|STANDARD_DEVIATION|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||20.82|8.72|<0.001
74098728|NCT00468650|147746058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.58|STANDARD_DEVIATION|37.77||0.001||95.0|-19.96|-5.2||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||-5.20|-19.96|0.0010
74098729|NCT00468650|147746058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.55|STANDARD_DEVIATION|35.04|<|0.001||95.0|-27.47|-13.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-13.64|-27.47|<0.001
74098730|NCT00468650|147746058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.53|STANDARD_DEVIATION|36.64|<|0.001||95.0|-29.88|-15.18||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-15.18|-29.88|<0.001
74098731|NCT00468650|147746058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.44|STANDARD_DEVIATION|36.06|<|0.001||95.0|-28.49|-14.39||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-14.39|-28.49|<0.001
74098732|NCT00468650|147746058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.86|STANDARD_DEVIATION|36.29|<|0.001||95.0|-29.03|-14.7||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-14.70|-29.03|<0.001
74098733|NCT00468650|147746059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.79|STANDARD_DEVIATION|22.58||0.0021||95.0|-11.06|-2.52||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||-2.52|-11.06|0.0021
74098734|NCT00468650|147746059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.85|STANDARD_DEVIATION|23.02||0.0027||95.0|-11.26|-2.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||-2.43|-11.26|0.0027
74098735|NCT00468650|147746059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.43|STANDARD_DEVIATION|24.2||0.0015||95.0|-11.97|-2.9||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||-2.90|-11.97|0.0015
74049912|NCT02607865|147652695|SUPERIORITY|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||=|0.0185|TWO_SIDED|95.0|-1.1|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-1.1|= 0.0185
74049913|NCT02607865|147652695|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.1|-2.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-2.1|-3.1|<0.0001
74049914|NCT02607865|147652695|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.1|-2.0|<0.0001
74049915|NCT02607865|147652695|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|type Mean treatment difference|-0.5|||=|0.0257|TWO_SIDED|95.0|-1.0|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-1.0|=0.0257
74049916|NCT02607865|147652716|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.34|||=|0.0063|TWO_SIDED|95.0|1.09|1.65||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.65|1.09|=0.0063
74049917|NCT02607865|147652716|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0.0221|TWO_SIDED|95.0|0.61|0.96||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.96|0.61|=0.0221
74049918|NCT02607865|147652716|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.68|0.41|<0.0001
74049919|NCT02607865|147652717|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33|||=|0.016|TWO_SIDED|95.0|1.05|1.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.68|1.05|=0.0160
74098736|NCT00468650|147746059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.57|STANDARD_DEVIATION|24.4||0.0015||95.0|-12.18|-2.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||-2.96|-12.18|0.0015
74098737|NCT00468650|147746060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.87|STANDARD_DEVIATION|34.44||0.0045||95.0|-16.6|-3.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||-3.14|-16.60|0.0045
74098738|NCT00468650|147746060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.74|STANDARD_DEVIATION|32.8|<|0.001||95.0|-18.22|-5.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-5.27|-18.22|<0.001
74049920|NCT02607865|147652717|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.66|||=|0.0022|TWO_SIDED|95.0|0.51|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.86|0.51|=0.0022
74049921|NCT02607865|147652717|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.22|0.43||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.43|0.22|<0.0001
74049922|NCT01603628|147652749|SUPERIORITY||Least Squares (LS) Mean Difference|-0.26||||0.01|TWO_SIDED|95.0|-0.453|-0.063||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||-0.063|-0.453|0.010
74049923|NCT01603628|147652749|SUPERIORITY||LS Mean Difference|-0.21||||0.033|TWO_SIDED|95.0|-0.405|-0.018||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||-0.018|-0.405|0.033
74049924|NCT01603628|147652750|SUPERIORITY||LS Mean Difference|0.29||||0.023|TWO_SIDED|95.0|0.04|0.532||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||0.532|0.040|0.023
74049925|NCT01603628|147652750|SUPERIORITY||LS Mean Difference|0.13||||0.299|TWO_SIDED|95.0|-0.115|0.374||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||0.374|-0.115|0.299
74049926|NCT01603628|147652751|SUPERIORITY||LS Mean Difference|0.41||||0.005|TWO_SIDED|95.0|0.126|0.704||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.704|0.126|0.005
74049927|NCT01603628|147652751|SUPERIORITY||LS Mean Difference|0.29||||0.047|TWO_SIDED|95.0|0.004|0.573||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.573|0.004|0.047
74049928|NCT01603628|147652751|SUPERIORITY||LS Mean Difference|0.45||||0.004|TWO_SIDED|95.0|0.145|0.756||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.756|0.145|0.004
74049929|NCT01603628|147652751|SUPERIORITY||LS Mean Difference|0.44||||0.004|TWO_SIDED|95.0|0.141|0.74||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.740|0.141|0.004
74049930|NCT01603628|147652751|SUPERIORITY||LS Mean Difference|0.49||||0.001|TWO_SIDED|95.0|0.191|0.797||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.797|0.191|0.001
74049931|NCT01603628|147652751|SUPERIORITY||LS Mean Difference|0.22||||0.153|TWO_SIDED|95.0|-0.081|0.541||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.541|-0.081|0.153
74049932|NCT01603628|147652751|SUPERIORITY||LS Mean Difference|0.41||||0.01|TWO_SIDED|95.0|0.1|0.711||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.711|0.100|0.010
74049933|NCT01603628|147652751|SUPERIORITY||LS Mean Difference|0.27||||0.078|TWO_SIDED|95.0|-0.031|0.571||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.571|-0.031|0.078
74049934|NCT01603628|147652752|SUPERIORITY||LS Mean Difference|-1.99||||0.158|TWO_SIDED|95.0|-4.768|0.779||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2||0.779|-4.768|0.158
74049935|NCT01603628|147652752|SUPERIORITY||LS Mean Difference|-3.25||||0.02|TWO_SIDED|95.0|-5.974|-0.524||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2||-0.524|-5.974|0.020
74098739|NCT00468650|147746060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.78|STANDARD_DEVIATION|33.56|<|0.001||95.0|-19.51|-6.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-6.05|-19.51|<0.001
74098740|NCT00468650|147746060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.13|STANDARD_DEVIATION|33.94|<|0.001||95.0|-19.76|-6.5||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-6.50|-19.76|<0.001
73881276|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0431|TWO_SIDED|95.0|1.03|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.76|1.03|0.0431
73881277|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|4.4||||0.002|TWO_SIDED|95.0|1.72|11.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.29|1.72|0.0020
73881278|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0291|TWO_SIDED|95.0|1.11|6.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.86|1.11|0.0291
74049936|NCT01603628|147652752|SUPERIORITY||LS Mean Difference|-1.42||||0.363|TWO_SIDED|95.0|-4.489|1.648||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4||1.648|-4.489|0.363
74098741|NCT00468650|147746060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.4|STANDARD_DEVIATION|33.13|<|0.001||95.0|-18.94|-5.86||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-5.86|-18.94|<0.001
74098742|NCT00468650|147746061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.39|STANDARD_DEVIATION|22.0||0.2567||95.0|-6.55|1.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.77|-6.55|0.2567
74049937|NCT01603628|147652752|SUPERIORITY||LS Mean Difference|-2.11||||0.171|TWO_SIDED|95.0|-5.127|0.914||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4||0.914|-5.127|0.171
74049938|NCT01603628|147652752|SUPERIORITY||LS Mean Difference|-3.33||||0.02|TWO_SIDED|95.0|-6.143|-0.525||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6||-0.525|-6.143|0.020
74049939|NCT01603628|147652752|SUPERIORITY||LS Mean Difference|-3.92||||0.006|TWO_SIDED|95.0|-6.688|-1.148||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6||-1.148|-6.688|0.006
74049940|NCT01603628|147652752|SUPERIORITY||LS Mean Difference|-2.07||||0.254|TWO_SIDED|95.0|-5.621|1.491||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8||1.491|-5.621|0.254
74049941|NCT01603628|147652752|SUPERIORITY||LS Mean Difference|-2.46||||0.165|TWO_SIDED|95.0|-5.935|1.014||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8||1.014|-5.935|0.165
74049942|NCT01603628|147652752|SUPERIORITY||LS Mean Difference|-2.61||||0.078|TWO_SIDED|95.0|-5.517|0.296||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12||0.296|-5.517|0.078
74049943|NCT01603628|147652752|SUPERIORITY||LS Mean Difference|-1.09||||0.451|TWO_SIDED|95.0|-3.944|1.758||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12||1.758|-3.944|0.451
74098743|NCT00468650|147746061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.91|STANDARD_DEVIATION|20.73||0.3435||95.0|-5.88|2.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||2.07|-5.88|0.3435
74098744|NCT00468650|147746061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.71|STANDARD_DEVIATION|22.28||0.2||95.0|-6.89|1.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.46|-6.89|0.2000
74098745|NCT00468650|147746061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.76|STANDARD_DEVIATION|22.48||0.2||95.0|-7.01|1.48||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.48|-7.01|0.2000
74098746|NCT00468650|147746062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.82|STANDARD_DEVIATION|56.75||0.0558||95.0|-21.91|0.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||0.27|-21.91|0.0558
74098747|NCT00468650|147746062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-29.16|STANDARD_DEVIATION|59.81|<|0.001||95.0|-40.96|-17.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-17.35|-40.96|<0.001
73881279|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0063|TWO_SIDED|95.0|1.48|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.61|1.48|0.0063
73881280|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0202|TWO_SIDED|95.0|1.19|8.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.11|1.19|0.0202
73881281|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|4.1||||0.0044|TWO_SIDED|95.0|1.55|10.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.84|1.55|0.0044
73881282|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|9.21||||0.0002|TWO_SIDED|95.0|2.89|29.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||29.38|2.89|0.0002
74049944|NCT01756833|147652758|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.035||0.71|TWO_SIDED|95.0|-0.07|0.07||Two prespecified interim analyses for efficacy performed when 1/3 \& 2/3 of primary outcome available, significance level, 1-sided, alpha=.0005. Final analysis 1-sided, alpha=.024. Futility analysis performed when \~2/3 primary outcome was available.|ANCOVA on normal scores|||"Null hypothesis: normal score of MTD at follow-up adjusted for baseline and gender in doxycycline assigned patients - normal score of MTD at follow-up adjusted for baseline and gender in placebo assigned patients = 0.~Sample size: The criterion (alpha) set for statistical significance was 1-sided .025; use of this level means that the inference from the test result will be the same as the inference from 2-sided testing at the .05 significance level."|For the primary analysis, diameters at baseline were ranked from smallest to largest (ranks 1-254). At the 2-year follow-up, ranks 1 through 225 were assigned to the diameters of surviving patients with no aneurysm repair (with missing values estimated by multiple imputation), ranks 226 through 247 were assigned to surviving patients who underwent aneurysm repair (in order of longest to shortest time from randomization to repair), and ranks 248 through 254 were assigned to patients who died (in order of longest to shortest time from randomization to death). Each rank was converted to a normal score corresponding to the value on the standard normal curve (z score) of its percentile among all 254 ranks. The primary analysis was based on linear regression of the change in normal scores from baseline to 2 years. Independent variables were baseline normal score, sex, and a dichotomous variable for the randomly assigned treatment group (0 for placebo, 1 for doxycycline).|0.07|-0.07|0.71
74098748|NCT00468650|147746062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.79|STANDARD_DEVIATION|60.9|<|0.001||95.0|-43.0|-18.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-18.58|-43.00|<0.001
74098749|NCT00468650|147746062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.27|STANDARD_DEVIATION|61.7|<|0.001||95.0|-42.33|-18.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-18.21|-42.33|<0.001
74098750|NCT00468650|147746062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.87|STANDARD_DEVIATION|60.54|<|0.001||95.0|-42.82|-18.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-18.92|-42.82|<0.001
74098751|NCT00468650|147746063|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-18.36|STANDARD_DEVIATION|46.03|<|0.001||95.0|-27.05|-9.66||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||-9.66|-27.05|<0.001
74098752|NCT00468650|147746063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.16|STANDARD_DEVIATION|45.24|<|0.001||95.0|-30.84|-13.49||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||-13.49|-30.84|<0.001
74098753|NCT00468650|147746063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.28|STANDARD_DEVIATION|45.86|<|0.001||95.0|-28.87|-11.69||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||-11.69|-28.87|<0.001
74098754|NCT00468650|147746063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.65|STANDARD_DEVIATION|46.2|<|0.001||95.0|-29.38|-11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||-11.92|-29.38|<0.001
74098755|NCT00468650|147746064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|33.27|STANDARD_DEVIATION|41.43|<|0.001||95.0|25.17|41.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||41.36|25.17|<0.001
74098756|NCT00468650|147746064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|61.45|STANDARD_DEVIATION|44.77|<|0.001||95.0|52.61|70.29||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||70.29|52.61|<0.001
74098757|NCT00468650|147746064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|66.1|STANDARD_DEVIATION|45.15|<|0.001||95.0|57.05|75.16||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||75.16|57.05|<0.001
73881283|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0706|TWO_SIDED|95.0|0.93|6.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.37|0.93|0.0706
73881284|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|8.2||||0.0001|TWO_SIDED|95.0|2.79|24.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||24.08|2.79|0.0001
73881285|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0146|TWO_SIDED|95.0|1.26|8.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.32|1.26|0.0146
73881286|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0816|TWO_SIDED|95.0|0.9|6.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.24|0.90|0.0816
74018859|NCT01337973|147590076|SUPERIORITY||Coefficient Estimate|0.8|||<|0.05|TWO_SIDED|95.0|0.32|1.98||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.01|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline||1.98|0.32|<0.05
74049945|NCT00886587|147652766|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.04||||0.9416|TWO_SIDED|95.0|-1.09|1.17||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.17|-1.09|0.9416
74049946|NCT00886587|147652767|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.35||||0.5431|TWO_SIDED|95.0|-0.78|1.48||The significance level threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.48|-0.78|0.5431
74049947|NCT00886587|147652768|SUPERIORITY_OR_OTHER||Estimated Mean Difference|-0.06||||0.788|TWO_SIDED|95.0|-0.47|0.36||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment as a factor, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.36|-0.47|0.788
74049948|NCT00886587|147652769|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.03||||0.9508|TWO_SIDED|95.0|-0.9|0.96||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.96|-0.90|0.9508
74049949|NCT04107935|147652777|SUPERIORITY|||||||0.983||||||Propensity score matching was used to form pairs of intervention and control participants. Specifically, a greedy matching procedure with a matching caliper of 0.2 of the standard deviation of the logit of the propensity score was used.|Mixed Models Analysis|Since baseline characteristics achieved a good balance, those variables were not entered into the propensity score matched model.||||||0.9830
74049950|NCT04107935|147652778|SUPERIORITY|||||||0.8365||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.8365
74098758|NCT00468650|147746064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|64.84|STANDARD_DEVIATION|45.7|<|0.001||95.0|55.91|73.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||73.77|55.91|<0.001
74098759|NCT00468650|147746064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|65.13|STANDARD_DEVIATION|45.56|<|0.001||95.0|56.14|74.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||74.12|56.14|<0.001
74098760|NCT00468650|147746065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|27.53|STANDARD_DEVIATION|40.19|<|0.001||95.0|19.94|35.13||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||35.13|19.94|<0.001
73881287|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.25||||0.093|TWO_SIDED|95.0|0.87|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.81|0.87|0.0930
73881288|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.81||||0.365|TWO_SIDED|95.0|1.07|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.39|1.07|0.365
74049951|NCT04107935|147652779|SUPERIORITY|||||||0.5727||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.5727
74049952|NCT04107935|147652780|SUPERIORITY|||||||0.9381||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.9381
74049953|NCT04107935|147652782|SUPERIORITY|||||||0.608||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.608
74098761|NCT00468650|147746065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.92|STANDARD_DEVIATION|41.9|<|0.001||95.0|22.89|38.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||38.95|22.89|<0.001
74098762|NCT00468650|147746065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.43|STANDARD_DEVIATION|41.88|<|0.001||95.0|22.59|38.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||38.27|22.59|<0.001
74049954|NCT00374452|147652803|OTHER||||||>|0.1|||||||Mixed Models Analysis|||We compared the mean percentages of events per clinician between study arms, using mixed model regression adjusting for medical center, clinic type (community-based clinic vs not), clinician discipline (MD vs non-MD), presence of pharmacist in the clinic, and mean age of clinician's panels of patients as fixed effects, and clinic as a random effect to account for clustering of clinicians within clinics.||||>0.1
74049955|NCT04623255|147652804|SUPERIORITY|||||||0.16|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in at least two inflammation markers' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.16
74049956|NCT04623255|147652805|SUPERIORITY|||||||0.606|TWO_SIDED|95.0|||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker CRP' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.606
74049957|NCT04623255|147652806|SUPERIORITY|||||||0.245|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker D-Dimer' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.245
74049958|NCT04623255|147652807|SUPERIORITY|||||||0.653|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker LDH' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.653
74049959|NCT00998985|147652811|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|3.46|||||TWO_SIDED|90.0|2.89|4.03|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||4.03|2.89|
74049960|NCT00998985|147652811|SUPERIORITY_OR_OTHER||LSM Difference|4.68|||||TWO_SIDED|90.0|4.11|5.25|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.25|4.11|
74049961|NCT00998985|147652811|SUPERIORITY_OR_OTHER||LSM Difference|4.87|||||TWO_SIDED|90.0|4.3|5.44|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.44|4.30|
74049962|NCT00998985|147652811|SUPERIORITY_OR_OTHER||LSM Difference|4.35|||||TWO_SIDED|90.0|3.78|4.92|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||4.92|3.78|
74049963|NCT00998985|147652811|SUPERIORITY_OR_OTHER||LSM Difference|5.15|||||TWO_SIDED|90.0|4.58|5.72|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.72|4.58|
74018860|NCT01337973|147590076|SUPERIORITY||Coefficient Estimate|0.6|||<|0.001|TWO_SIDED|95.0|0.25|1.46||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||1.46|0.25|<0.001
74049964|NCT00998985|147652811|SUPERIORITY_OR_OTHER||LSM Difference|4.76|||||TWO_SIDED|90.0|4.19|5.33|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.33|4.19|
74098763|NCT00468650|147746065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.98|STANDARD_DEVIATION|42.06|<|0.001||95.0|23.04|38.93||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||38.93|23.04|<0.001
74098764|NCT00468650|147746066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|22.45|STANDARD_DEVIATION|46.1|<|0.001||95.0|13.44|31.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||31.46|13.44|<0.001
74098765|NCT00468650|147746066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|32.3|STANDARD_DEVIATION|42.15|<|0.001||95.0|23.97|40.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||40.62|23.97|<0.001
74049965|NCT00998985|147652811|SUPERIORITY_OR_OTHER||LSM Difference|4.93|||||TWO_SIDED|90.0|4.36|5.5|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.50|4.36|
73881289|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|4.93||||0.0042|TWO_SIDED|95.0|1.65|14.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.73|1.65|0.0042
74018861|NCT01337973|147590076|SUPERIORITY||Coefficient Estimate|1.05|||<|0.001|TWO_SIDED|95.0|0.45|2.44||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.74|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline||2.44|0.45|<0.001
74018862|NCT01337973|147590076|SUPERIORITY||Coefficient Estimate|0.48|||<|0.01|TWO_SIDED|95.0|0.13|1.78||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.59|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||1.78|0.13|<0.01
74018863|NCT01337973|147590076|SUPERIORITY||Coefficient Estimate|0.48|||>|0.05|TWO_SIDED|95.0|0.16|1.47||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -1.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||1.47|0.16|>0.05
74018864|NCT01337973|147590076|SUPERIORITY||Coefficient Estimate|1.12|||<|0.001|TWO_SIDED|95.0|0.6|2.08||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.10|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||2.08|0.60|<0.001
74018865|NCT01337973|147590076|SUPERIORITY||Coefficient Estimate|1.09|||<|0.01|TWO_SIDED|95.0|0.4|2.95||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.17|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline||2.95|0.40|<0.01
74018866|NCT01337973|147590076|SUPERIORITY||||||<|0.001||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.69||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||||<0.001
74018867|NCT01337973|147590076|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.32||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury % change from baseline||||<0.01
74018868|NCT01337973|147590076|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.90||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||||<0.01
73881290|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.73||||0.0488|TWO_SIDED|95.0|1.01|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.41|1.01|0.0488
74018869|NCT01337973|147590076|SUPERIORITY||||||>|0.05||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -1.02||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||||>0.05
74018870|NCT01337973|147590076|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -4.01||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||||<0.01
74098766|NCT00468650|147746066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|35.31|STANDARD_DEVIATION|43.52|<|0.001||95.0|26.59|44.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||44.04|26.59|<0.001
74098767|NCT00468650|147746066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.57|STANDARD_DEVIATION|43.48|<|0.001||95.0|26.07|43.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||43.07|26.07|<0.001
74098768|NCT00468650|147746066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.26|STANDARD_DEVIATION|43.29|<|0.001||95.0|25.72|42.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||42.81|25.72|<0.001
74098769|NCT00468650|147746067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.18|STANDARD_DEVIATION|29.45||0.0014||95.0|3.61|14.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||14.74|3.61|0.0014
74098770|NCT00468650|147746067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.75|STANDARD_DEVIATION|29.26||0.0025||95.0|3.15|14.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||14.36|3.15|0.0025
74049966|NCT00998985|147652811|SUPERIORITY_OR_OTHER||LSM Difference|5.34|||||TWO_SIDED|90.0|4.93|5.74|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.74|4.93|
74049967|NCT00998985|147652812|SUPERIORITY_OR_OTHER||LSM Difference|2.25|||||TWO_SIDED|90.0|1.7|2.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||2.81|1.70|
74049968|NCT00998985|147652812|SUPERIORITY_OR_OTHER||LSM Difference|2.94|||||TWO_SIDED|90.0|2.38|3.49|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||3.49|2.38|
74049969|NCT00998985|147652812|SUPERIORITY_OR_OTHER||LSM Difference|3.84|||||TWO_SIDED|90.0|3.29|4.4|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||4.40|3.29|
74049970|NCT00998985|147652812|SUPERIORITY_OR_OTHER||LSM difference|4.98|||||TWO_SIDED|90.0|4.42|5.53|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||5.53|4.42|
74049971|NCT00998985|147652812|SUPERIORITY_OR_OTHER||LSM difference|4.21|||||TWO_SIDED|90.0|3.6|4.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||4.81|3.60|
74049972|NCT01040728|147652813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.197|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.163|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.231|0.163|<0.0001
74049973|NCT01040728|147652813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.186|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.255|0.186|<0.0001
74049974|NCT01040728|147652813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.187|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.255|0.187|<0.0001
74049975|NCT01040728|147652814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.117|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.188|0.117|<0.0001
74049976|NCT01040728|147652814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.134|0.205|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.205|0.134|<0.0001
74049977|NCT01040728|147652814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.128|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.199|0.128|<0.0001
74049978|NCT01040728|147652815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.141|0.208|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.208|0.141|<0.0001
74049979|NCT01040728|147652815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.157|0.225|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.225|0.157|<0.0001
74049980|NCT01040728|147652815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.159|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.226|0.159|<0.0001
74049981|NCT01040728|147652816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.181|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.248|0.181|<0.0001
74049982|NCT01040728|147652816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.205|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.272|0.205|<0.0001
74049983|NCT01040728|147652816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.119|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.185|0.119|<0.0001
74049984|NCT01040728|147652817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.178|0.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.251|0.178|<0.0001
74049985|NCT01040728|147652817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.208|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.208|<0.0001
73881291|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0075|TWO_SIDED|95.0|1.43|10.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.36|1.43|0.0075
73881292|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0984|TWO_SIDED|95.0|0.86|5.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.59|0.86|0.0984
74018871|NCT01337973|147590076|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.21||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall non-partner injury % change from baseline||||<0.01
74049986|NCT01040728|147652817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.199|0.271|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.271|0.199|<0.0001
74049987|NCT01040728|147652818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.201|0.273|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.273|0.201|<0.0001
74049988|NCT01040728|147652818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.266|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.23|0.302|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.302|0.230|<0.0001
74049989|NCT01040728|147652818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.138|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.211|0.138|<0.0001
74098771|NCT00468650|147746067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.15|STANDARD_DEVIATION|31.11|<|0.001||95.0|4.32|15.97||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||15.97|4.32|<0.001
74098772|NCT00468650|147746067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.33|STANDARD_DEVIATION|31.36|<|0.001||95.0|4.41|16.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||16.26|4.41|<0.001
74098773|NCT02639052|147746068|SUPERIORITY_OR_OTHER|||||||0.9704||||||Significance defined a priori as p\<0.05. P-values not adjusted for multiple comparisons.|ANOVA with Repeated Measures|||Baseline assessment of itch VAS after itch induction but prior to Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||0.9704
74098774|NCT02639052|147746069|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 week (Visit 2) was the first assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||<0.0001
74049990|NCT01040728|147652819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.169|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.246|0.169|<0.0001
74049991|NCT01040728|147652819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.205|<0.0001
74049992|NCT01040728|147652819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.282|0.205|<0.0001
74098775|NCT02639052|147746070|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Statistically significant difference in mean itch VAS between the two treatments (Botox mean=2.45 versus saline mean=3.20, p\<0.0001). Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 month (Visit 3) was the second assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||<0.0001
73881293|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2226|TWO_SIDED|95.0|0.68|5.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.29|0.68|0.2226
73881294|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1467|TWO_SIDED|95.0|0.76|6.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.08|0.76|0.1467
74049993|NCT01040728|147652820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.097|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.171|0.097|<0.0001
74049994|NCT01040728|147652820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.105|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.181|0.105|<0.0001
74049995|NCT01040728|147652820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.12|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.195|0.120|<0.0001
74049996|NCT01040728|147652821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.276|0.384|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.384|0.276|<0.0001
74049997|NCT01040728|147652821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.326|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.272|0.381|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.381|0.272|<0.0001
74049998|NCT01040728|147652821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.316|0.424|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.424|0.316|<0.0001
74049999|NCT01040728|147652822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.214|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.342|0.214|<0.0001
74050000|NCT01040728|147652822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.2|0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.329|0.200|<0.0001
74050001|NCT01040728|147652822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.238|0.366|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.366|0.238|<0.0001
74050002|NCT01040728|147652823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.244|0.363|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.363|0.244|<0.0001
74050003|NCT01040728|147652823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.222|0.343|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.343|0.222|<0.0001
74050004|NCT01040728|147652823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.335|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.275|0.395|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.395|0.275|<0.0001
74050005|NCT01040728|147652824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.309|0.43|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.430|0.309|<0.0001
74050006|NCT01040728|147652824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.366|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.306|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.426|0.306|<0.0001
74098776|NCT02639052|147746071|SUPERIORITY_OR_OTHER|||||||0.0004||||||Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|Analyzed using ANOVA with repeated measures to compare treatment (Botox vs saline), time, and interaction effect between treatment \& time||3 months (Visit 4) was the third assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||0.0004
74098777|NCT02639052|147746072|SUPERIORITY_OR_OTHER|||||||0.1306||||||Statistical significance defined a priori as p\<0.05.|ANOVA with Repeated Measures|||Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and visit, and interaction effect between treatment and visit.||||0.1306
74098778|NCT02730351|147746074|OTHER||Mean Difference (Final Values)|-1.69||||0.109|TWO_SIDED|95.0|-3.76|0.39||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis|||||0.39|-3.76|0.109
74050007|NCT01040728|147652824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.202|0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.322|0.202|<0.0001
74050008|NCT01040728|147652825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.344|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.287|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.401|0.287|<0.0001
74050009|NCT01040728|147652825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.296|0.411|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.411|0.296|<0.0001
74098779|NCT02730351|147746075|OTHER||Mean Difference (Final Values)|-2.15||||0.051|TWO_SIDED|95.0|-4.31|0.01||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis|||||0.01|-4.31|0.051
74050010|NCT01040728|147652825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.314|0.427|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.427|0.314|<0.0001
74050011|NCT01040728|147652826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.334|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.272|0.396|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.396|0.272|<0.0001
74050012|NCT01040728|147652826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.346|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.283|0.408|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.408|0.283|<0.0001
74050013|NCT01040728|147652826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.378|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.316|0.44|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.440|0.316|<0.0001
74050014|NCT01040728|147652827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.179|0.309|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.309|0.179|<0.0001
74050015|NCT01040728|147652827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.15|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.150|<0.0001
74050016|NCT01040728|147652827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.191|0.321|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.321|0.191|<0.0001
74050017|NCT02573012|147652829|SUPERIORITY||Least Square Means|0.613||||0.001|TWO_SIDED|95.0|0.346|0.879|||ANCOVA|||||0.879|0.346|0.001
74050018|NCT02573012|147652830|SUPERIORITY||Odds Ratio (OR)|0.5||||0.018|TWO_SIDED|95.0|0.285|0.889|||Regression, Logistic|||||0.889|0.285|0.018
74098780|NCT02730351|147746076|OTHER||Odds Ratio (OR)|1.34||||0.266|TWO_SIDED|95.0|0.8|2.26||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method. Covariates of treatment, sex, age, treatment period, and period baseline FEV1 were included.|Regression, Logistic||12 hrs: modeling the odds of having FEV1 \>/=95% of pre exercise FEV1 at each of the two time points.|||2.26|0.80|0.266
74050019|NCT02573012|147652830|SUPERIORITY||Relative Risk|0.833||||0.021|TWO_SIDED|95.0|0.714|0.972|||Cochran-Mantel-Haenszel|||||0.972|0.714|0.021
74050020|NCT02573012|147652831|SUPERIORITY||Least Square Mean|2.342||||0.006|TWO_SIDED|95.0|0.661|4.023|||ANCOVA|||||4.023|0.661|0.006
74050021|NCT02573012|147652851|SUPERIORITY||Least Square Means|2.264||||0.009||95.0|0.574|3.953|||ANCOVA|||||3.953|0.574|0.009
74050022|NCT02483611|147652883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|149.0|STANDARD_DEVIATION|46.07||0.9651|TWO_SIDED|95.0|88.0|235.0|||ANOVA|||||235|88|0.9651
74050023|NCT02483611|147652883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|145.3|STANDARD_DEVIATION|42.48||0.9651|TWO_SIDED|95.0|78.0|244.0|||ANOVA|||||244|78|0.9651
74050024|NCT02483611|147652883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|147.8|STANDARD_DEVIATION|29.75||0.9651|TWO_SIDED|95.0|105.0|200.0|||ANOVA|||The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. The pharmacodynamic (latency, clinical duration, recovery rate and total duration) and hemodynamic variables (mean arterial pressure (MAP) and HR) were compared between the groups via analysis of variance (ANOVA) followed by the Tukey post-hoc test. The significance level was set at 5%.||200|105|0.9651
74050025|NCT02483611|147652884|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|82.68|||<|0.0001|TWO_SIDED|95.0|72.62|99.27|||Kruskal-Wallis|||||99.27|72.62|<0.0001
74050026|NCT02483611|147652884|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|86.33|||<|0.0001|TWO_SIDED|95.0|71.78|140.6|||Kruskal-Wallis|||||140.60|71.78|<0.0001
74050027|NCT02483611|147652884|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.8|||<|0.0001|TWO_SIDED|95.0|40.5|92.9|||Kruskal-Wallis|||||92.90|40.50|<0.0001
74050028|NCT02483611|147652885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.08|STANDARD_DEVIATION|6.49||0.0015|TWO_SIDED|95.0|12.0|32.25|||ANOVA|||||32.25|12.00|0.0015
74050029|NCT02483611|147652885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.26|STANDARD_DEVIATION|7.69||0.0015|TWO_SIDED|95.0|10.5|39.83|||ANOVA|||||39.83|10.50|0.0015
74050030|NCT02483611|147652885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.53|STANDARD_DEVIATION|1.52||0.0015|TWO_SIDED|95.0|11.0|16.5|||ANOVA|||||16.50|11.00|0.0015
74050031|NCT02483611|147652886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.97|STANDARD_DEVIATION|6.77||0.0003|TWO_SIDED|95.0|19.5|41.5|||ANOVA|||||41.50|19.50|0.0003
74050032|NCT02483611|147652886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.81|STANDARD_DEVIATION|10.97||0.0003|TWO_SIDED|95.0|18.5|49.5|||ANOVA|||||49.50|18.50|0.0003
74050033|NCT02483611|147652886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.51|STANDARD_DEVIATION|3.28||0.0003|TWO_SIDED|95.0|17.5|30.05|||ANOVA|||||30.05|17.50|0.0003
74050034|NCT02483611|147652887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.2|STANDARD_DEVIATION|12.16|<|0.0001|TWO_SIDED|95.0|94.87|136.8|||ANOVA|||||136.80|94.87|<0.0001
74050035|NCT02483611|147652887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.1|STANDARD_DEVIATION|18.2|<|0.0001|TWO_SIDED|95.0|95.82|163.3|||ANOVA|||||163.30|95.82|<0.0001
74050036|NCT02483611|147652887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.19|STANDARD_DEVIATION|16.34|<|0.0001|TWO_SIDED|95.0|58.0|125.2|||ANOVA|||||125.20|58|<0.0001
74050037|NCT02483611|147652888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.2|STANDARD_DEVIATION|10.88|<|0.0001|TWO_SIDED|95.0|106.3|140.2|||ANOVA|||||140.20|106.30|<0.0001
74050038|NCT02483611|147652888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|126.7|STANDARD_DEVIATION|14.19|<|0.0001|TWO_SIDED|95.0|106.5|149.4|||ANOVA|||||149.40|106.50|<0.0001
74050039|NCT02483611|147652888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.03|STANDARD_DEVIATION|12.78|<|0.0001|TWO_SIDED|95.0|71.75|116.4|||ANOVA|||||116.40|71.75|<0.0001
74050040|NCT02483611|147652889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|94.63|STANDARD_DEVIATION|10.18||0.0527|TWO_SIDED|95.0|70.0|112.0|||ANOVA|||||112.00|70.00|0.0527
74050041|NCT02483611|147652889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.75|STANDARD_DEVIATION|10.05||0.0527|TWO_SIDED|95.0|65.0|104.0|||ANOVA|||||104.00|65.00|0.0527
74050042|NCT02483611|147652889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.1|STANDARD_DEVIATION|16.62||0.0527|TWO_SIDED|95.0|70.0|140.0|||ANOVA|||||140.00|70.00|0.0527
74050043|NCT02483611|147652890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.63|STANDARD_DEVIATION|12.1||0.1996|TWO_SIDED|95.0|60.0|110.0|||ANOVA|||||110.00|60.00|0.1996
74050044|NCT02483611|147652890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|84.69|STANDARD_DEVIATION|11.38||0.1996|TWO_SIDED|95.0|67.0|109.0|||ANOVA|||||109.00|67.00|0.1996
74050045|NCT02483611|147652890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|92.47|STANDARD_DEVIATION|12.3||0.1996|TWO_SIDED|95.0|73.0|112.0|||ANOVA|||||112.00|73.00|0.1996
74050046|NCT02483611|147652891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.88|STANDARD_DEVIATION|11.95||0.7145|TWO_SIDED|95.0|58.0|107.0|||ANOVA|||||107.00|58.00|0.7145
74050047|NCT02483611|147652891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.88|STANDARD_DEVIATION|9.8||0.7145|TWO_SIDED|95.0|59.0|97.0|||ANOVA|||||97.00|59.00|0.7145
74050048|NCT02483611|147652891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.73|STANDARD_DEVIATION|7.48||0.7145|TWO_SIDED|95.0|58.0|86.0|||ANOVA|||||86.00|58.00|0.7145
74050049|NCT02483611|147652892|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.113|TWO_SIDED|95.0|57.0|96.0|||Kruskal-Wallis|||||96.00|57.00|0.1130
74050050|NCT02483611|147652892|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0||||0.113|TWO_SIDED|95.0|55.0|84.0|||Kruskal-Wallis|||||84.00|55.00|0.1130
74050051|NCT02483611|147652892|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|74.0||||0.113|TWO_SIDED|95.0|59.0|83.0|||Kruskal-Wallis|||||83.00|59.00|0.1130
74050052|NCT02483611|147652893|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|62.5||||0.0731|TWO_SIDED|95.0|58.0|98.0|||Kruskal-Wallis|||||98.00|58.00|0.0731
74050053|NCT02483611|147652893|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.5||||0.0731|TWO_SIDED|95.0|55.0|74.0|||Kruskal-Wallis|||||74.00|55.00|0.0731
74050054|NCT02483611|147652893|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|67.0||||0.0731|TWO_SIDED|95.0|56.0|85.0|||Kruskal-Wallis|||||85.00|56.00|0.0731
74050055|NCT02483611|147652894|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.5||||0.1002|TWO_SIDED|95.0|60.0|85.0|||Kruskal-Wallis|||||85.00|60.00|0.1002
74050056|NCT02483611|147652894|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.0||||0.1002|TWO_SIDED|95.0|56.0|74.0|||Kruskal-Wallis|||||74.00|56.00|0.1002
74098781|NCT02730351|147746076|OTHER||Odds Ratio (OR)|1.37||||0.322|TWO_SIDED|95.0|0.73|2.58||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method|Regression, Logistic||23 hrs: modeling the odds of having FEV1 \>/=95% of pre exercise FEV1 at each of the two time points.|||2.58|0.73|0.322
74050057|NCT02483611|147652894|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.1002|TWO_SIDED|95.0|60.0|90.0|||Kruskal-Wallis|||||90.00|60.00|0.1002
74050058|NCT02483611|147652895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.94|STANDARD_DEVIATION|15.79||0.4338|TWO_SIDED|95.0|52.0|109.0|||ANOVA|||||109.00|52.00|0.4338
74050059|NCT02483611|147652895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.25|STANDARD_DEVIATION|12.13||0.4338|TWO_SIDED|95.0|55.0|95.0|||ANOVA|||||95.00|55.00|0.4338
74050060|NCT02483611|147652895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.67|STANDARD_DEVIATION|11.82||0.4338|TWO_SIDED|95.0|55.0|92.0|||ANOVA|||||92.00|55.00|0.4338
74050061|NCT02483611|147652896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|74.69|STANDARD_DEVIATION|11.76||0.9167|TWO_SIDED|95.0|57.0|99.0|||ANOVA|||||99.00|57.00|0.9167
74050062|NCT02483611|147652896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.69|STANDARD_DEVIATION|11.18||0.9167|TWO_SIDED|95.0|51.0|96.0|||ANOVA|||||96.00|51.00|0.9167
74050063|NCT02483611|147652896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.4|STANDARD_DEVIATION|11.54||0.9167|TWO_SIDED|95.0|53.0|90.0|||ANOVA|||||90.00|53.00|0.9167
74050064|NCT02483611|147652897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|72.94|STANDARD_DEVIATION|10.96||0.8067|TWO_SIDED|95.0|58.0|92.0|||ANOVA|||||92.00|58.00|0.8067
74050065|NCT02483611|147652897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|74.19|STANDARD_DEVIATION|8.65||0.8067|TWO_SIDED|95.0|57.0|86.0|||ANOVA|||||86.00|57.00|0.8067
74050066|NCT02483611|147652897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.4|STANDARD_DEVIATION|11.54||0.8067|TWO_SIDED|95.0|53.0|90.0|||ANOVA|||||90.00|53.00|0.8067
74050067|NCT02483611|147652898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.94|STANDARD_DEVIATION|10.87||0.1015|TWO_SIDED|95.0|57.0|93.0|||ANOVA|||||93.00|57.00|0.1015
74050068|NCT02483611|147652898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|72.25|STANDARD_DEVIATION|9.78||0.1015|TWO_SIDED|95.0|52.0|89.0|||ANOVA|||||89.00|52.00|0.1015
74050069|NCT02483611|147652898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.07|STANDARD_DEVIATION|10.01||0.1015|TWO_SIDED|95.0|44.0|81.0|||ANOVA|||||81.00|44.00|0.1015
74050070|NCT02483611|147652899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.56|STANDARD_DEVIATION|10.05||0.3423|TWO_SIDED|95.0|56.0|92.0|||ANOVA|||||92.00|56.00|0.3423
74050071|NCT02483611|147652899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.31|STANDARD_DEVIATION|7.73||0.3423|TWO_SIDED|95.0|57.0|83.0|||ANOVA|||||83.00|57.00|0.3423
74050072|NCT02483611|147652899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.27|STANDARD_DEVIATION|10.81||0.3423|TWO_SIDED|95.0|41.0|81.0|||ANOVA|||||81.00|41.00|0.3423
74050073|NCT02483611|147652900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.5|STANDARD_DEVIATION|10.11||0.6817|TWO_SIDED|95.0|53.0|92.0|||ANOVA|||||92.00|53.00|0.6817
74050074|NCT02483611|147652900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.19|STANDARD_DEVIATION|8.4||0.6817|TWO_SIDED|95.0|54.0|82.0|||ANOVA|||||82.00|54.00|0.6817
74050075|NCT02483611|147652900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.13|STANDARD_DEVIATION|10.5||0.6817|TWO_SIDED|95.0|47.0|81.0|||ANOVA|||||81.00|47.00|0.6817
74050076|NCT02483611|147652901|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.0937|TWO_SIDED|95.0|58.0|80.0|||Kruskal-Wallis|||||80.00|58.00|0.0937
74050077|NCT02483611|147652901|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.5||||0.0937|TWO_SIDED|95.0|56.0|90.0|||Kruskal-Wallis|||||90.00|56.00|0.0937
74050078|NCT02483611|147652901|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.0937|TWO_SIDED|95.0|58.0|87.0|||Kruskal-Wallis|||||87.00|58.00|0.0937
74050079|NCT02483611|147652902|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.5||||0.1406|TWO_SIDED|95.0|60.0|88.0|||Kruskal-Wallis|||||88.00|60.00|0.1406
74050080|NCT02483611|147652902|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.5||||0.1406|TWO_SIDED|95.0|55.0|86.0|||Kruskal-Wallis|||||86.00|55.00|0.1406
74050081|NCT02483611|147652902|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.1406|TWO_SIDED|95.0|55.0|84.0|||Kruskal-Wallis|||||84.00|55.00|0.1406
74050082|NCT02483611|147652903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.25|STANDARD_DEVIATION|6.74||0.0504|TWO_SIDED|95.0|60.0|81.0|||ANOVA|||||81.00|60.00|0.0504
74050083|NCT02483611|147652903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.0|STANDARD_DEVIATION|7.62||0.0504|TWO_SIDED|95.0|49.0|79.0|||ANOVA|||||79.00|49.00|0.0504
74050084|NCT02483611|147652903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.0|STANDARD_DEVIATION|7.56||0.0504|TWO_SIDED|95.0|58.0|84.0|||ANOVA|||||84.00|58.00|0.0504
74050085|NCT02483611|147652904|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.0205|TWO_SIDED|95.0|60.0|93.0|||Kruskal-Wallis|||||93.00|60.00|0.0205
74050086|NCT02483611|147652904|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|62.0||||0.0205|TWO_SIDED|95.0|54.0|72.0|||Kruskal-Wallis|||||72.00|54.00|0.0205
74050087|NCT02483611|147652904|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.0205|TWO_SIDED|95.0|59.0|75.0|||Kruskal-Wallis|||||75.00|59.00|0.0205
74050088|NCT02483611|147652905|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.3004|TWO_SIDED|95.0|58.0|86.0|||Kruskal-Wallis|||||86.00|58.00|0.3004
74050089|NCT02483611|147652905|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.3004|TWO_SIDED|95.0|56.0|78.0|||Kruskal-Wallis|||||78.00|56.00|0.3004
74050090|NCT02483611|147652905|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.3004|TWO_SIDED|95.0|62.0|81.0|||Kruskal-Wallis|||||81.00|62.00|0.3004
74050091|NCT02483611|147652906|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.0||||0.0178|TWO_SIDED|95.0|60.0|84.0|||Kruskal-Wallis|||||84.00|60.00|0.0178
73881295|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0705|TWO_SIDED|95.0|0.92|8.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.19|0.92|0.0705
73881296|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|26.62||||0.0025|TWO_SIDED|95.0|3.16|223.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||223.9|3.16|0.0025
74050092|NCT02483611|147652906|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.5||||0.0178|TWO_SIDED|95.0|51.0|75.0|||Kruskal-Wallis|||||75.00|51.00|0.0178
74050093|NCT02483611|147652906|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|72.0||||0.0178|TWO_SIDED|95.0|61.0|91.0|||Kruskal-Wallis|||||91.00|61.00|0.0178
74050094|NCT02483611|147652907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.67|STANDARD_DEVIATION|8.51||0.8746|TWO_SIDED|95.0|51.0|99.0|||ANOVA|||||99.00|51.00|0.8746
74050095|NCT02483611|147652907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.38|STANDARD_DEVIATION|6.96||0.8746|TWO_SIDED|95.0|56.0|82.0|||ANOVA|||||82.00|56.00|0.8746
74050096|NCT02483611|147652907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.4|STANDARD_DEVIATION|7.94||0.8746|TWO_SIDED|95.0|54.0|80.0|||ANOVA|||||80.00|54.00|0.8746
74050097|NCT02483611|147652908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.44|STANDARD_DEVIATION|10.95||0.4195|TWO_SIDED|95.0|47.0|92.0|||ANOVA|||||92.00|47.00|0.4195
74050098|NCT02483611|147652908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.38|STANDARD_DEVIATION|9.28||0.4195|TWO_SIDED|95.0|53.0|80.0|||ANOVA|||||80.00|53.00|0.4195
74050099|NCT02483611|147652908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.0|STANDARD_DEVIATION|8.23||0.4195|TWO_SIDED|95.0|52.0|80.0|||ANOVA|||||80.00|52.00|0.4195
74050100|NCT02483611|147652909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.75|STANDARD_DEVIATION|11.52||0.5796|TWO_SIDED|95.0|47.0|93.0|||ANOVA|||||93.00|47.00|0.5796
74050101|NCT02483611|147652909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.75|STANDARD_DEVIATION|10.19||0.5796|TWO_SIDED|95.0|48.0|79.0|||ANOVA|||||79.00|48.00|0.5796
74050102|NCT02483611|147652909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.33|STANDARD_DEVIATION|9.26||0.5796|TWO_SIDED|95.0|50.0|79.0|||ANOVA|||||79.00|50.00|0.5796
74050103|NCT02483611|147652910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.19|STANDARD_DEVIATION|12.82||0.5351|TWO_SIDED|95.0|45.0|92.0|||ANOVA|||||92.00|45.00|0.5351
74050104|NCT02483611|147652910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.31|STANDARD_DEVIATION|10.87||0.5351|TWO_SIDED|95.0|47.0|82.0|||ANOVA|||||82.00|47.00|0.5351
74050105|NCT02483611|147652910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|61.93|STANDARD_DEVIATION|9.0||0.5351|TWO_SIDED|95.0|51.0|79.0|||ANOVA|||||79.00|51.00|0.5351
74050106|NCT02483611|147652911|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.5||||0.4988|TWO_SIDED|95.0|42.0|92.0|||Kruskal-Wallis|||||92.00|42.00|0.4988
74050107|NCT02483611|147652911|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0||||0.4988|TWO_SIDED|95.0|50.0|85.0|||Kruskal-Wallis|||||85.00|50.00|0.4988
74050108|NCT02483611|147652911|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|58.0||||0.4988|TWO_SIDED|95.0|51.0|80.0|||Kruskal-Wallis|||||80.00|51.00|0.4988
74050109|NCT02483611|147652912|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.7723|TWO_SIDED|95.0|43.0|89.0|||Kruskal-Wallis|||||89.00|43.00|0.7723
74050110|NCT02483611|147652912|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.0||||0.7723|TWO_SIDED|95.0|51.0|82.0|||Kruskal-Wallis|||||82.00|51.00|0.7723
74050111|NCT02483611|147652912|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.0||||0.7723|TWO_SIDED|95.0|50.0|78.0|||Kruskal-Wallis|||||78.00|50.00|0.7723
74050112|NCT02871570|147652920|OTHER||ratio|0.7789|||||TWO_SIDED|90.0|0.6514|0.9313|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||0.9313|0.6514|
74050113|NCT02871570|147652921|OTHER||ratio|0.7776|||||TWO_SIDED|90.0|0.6493|0.9311|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||0.9311|0.6493|
74050114|NCT02871570|147652922|OTHER||ratio|1.2844|||||TWO_SIDED|90.0|1.0732|1.5372|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||1.5372|1.0732|
74050115|NCT02871570|147652923|OTHER||ratio|0.7945|||||TWO_SIDED|90.0|0.5955|1.0599|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||1.0599|0.5955|
74050116|NCT02545049|147652963|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0264|TWO_SIDED|95.0|0.76|0.98||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.98|0.76|0.0264
74050117|NCT02545049|147652964|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.87||||0.0689|TWO_SIDED|95.0|0.76|1.01||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.01|0.76|0.0689
73881297|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0757|TWO_SIDED|95.0|0.9|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.40|0.90|0.0757
73881298|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|5.66||||0.0045|TWO_SIDED|95.0|1.71|18.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||18.74|1.71|0.0045
73881299|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0771|TWO_SIDED|95.0|0.9|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.67|0.90|0.0771
73881300|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1856|TWO_SIDED|95.0|0.71|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.81|0.71|0.1856
73881301|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5973|TWO_SIDED|95.0|0.48|3.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.54|0.48|0.5973
74050118|NCT02545049|147652965|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.97||||0.3558|TWO_SIDED|95.0|0.9|1.04||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.04|0.90|0.3558
74050119|NCT02545049|147652966|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.89||||0.1337|TWO_SIDED|95.0|0.77|1.04||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.04|0.77|0.1337
74098782|NCT02730351|147746077|OTHER||Mean Difference (Final Values)|-0.65||||0.342|TWO_SIDED|95.0|-2.01|0.71||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis||12 hrs post-dose|||0.71|-2.01|0.342
73881302|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0935|TWO_SIDED|95.0|0.85|7.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.77|0.85|0.0935
73881303|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|5.52||||0.0157|TWO_SIDED|95.0|1.38|22.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||22.10|1.38|0.0157
74018872|NCT01337973|147590077|SUPERIORITY||Coefficient estimate|0.95|||<|0.001|TWO_SIDED|95.0|0.62|1.47||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.52|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||1.47|0.62|<0.001
74018873|NCT01337973|147590077|SUPERIORITY||coefficient estimate|0.49|||<|0.01|TWO_SIDED|95.0|0.18|1.32||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.98|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||1.32|0.18|<0.01
73881304|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1963|TWO_SIDED|95.0|0.68|6.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.32|0.68|0.1963
73881305|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|5.31||||0.0085|TWO_SIDED|95.0|1.53|18.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||18.43|1.53|0.0085
73881306|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1433|TWO_SIDED|95.0|0.76|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.38|0.76|0.1433
74018874|NCT01337973|147590077|SUPERIORITY||coefficient estimate|0.85|||<|0.05|TWO_SIDED|95.0|0.4|1.8||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.13|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||1.8|0.4|<0.05
73881307|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.17||||0.1577|TWO_SIDED|95.0|0.74|6.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.37|0.74|0.1577
73881308|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1608|TWO_SIDED|95.0|0.74|6.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.34|0.74|0.1608
73881309|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0693|TWO_SIDED|95.0|0.92|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.53|0.92|0.0693
73881310|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|9.57||||0.0063|TWO_SIDED|95.0|1.89|48.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||48.39|1.89|0.0063
73881311|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.25||||0.1637|TWO_SIDED|95.0|0.72|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.05|0.72|0.1637
74098783|NCT02730351|147746077|OTHER||Mean Difference (Final Values)|-1.75||||0.041|TWO_SIDED|95.0|-3.42|-0.07||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values.|Mixed Models Analysis||23 hrs post-dose|||-0.07|-3.42|0.041
74098784|NCT00838435|147746088|OTHER|Coefficient estimates from a random coefficient model and associated p-values.|Slope|-0.5768|||||TWO_SIDED|95.0|-1.6004|0.4468|||||The slope shown above is based on a 2-year window.|A random coefficient model was used to calculate the slope (per year) of FSIQ over the entire study period. Factors in the model included visit and testing sequence, with change in FSIQ score as the dependent variable. Random terms include both intercept and visit. The treatment was considered successful if the lower 95% confidence limit of the mean change excluded a decline of greater than 5 points over a 2-year window.||0.4468|-1.6004|
73881312|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0326|TWO_SIDED|95.0|1.11|11.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.47|1.11|0.0326
73881313|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.24||||0.1455|TWO_SIDED|95.0|0.76|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|0.76|0.1455
73881314|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1951|TWO_SIDED|95.0|0.69|6.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.32|0.69|0.1951
73881315|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.56||||0.4097|TWO_SIDED|95.0|0.54|4.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.53|0.54|0.4097
73881316|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1554|TWO_SIDED|95.0|0.73|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.22|0.73|0.1554
73881317|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|4.22||||0.044|TWO_SIDED|95.0|1.04|17.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.14|1.04|0.0440
73881318|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.23||||0.1928|TWO_SIDED|95.0|0.67|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.47|0.67|0.1928
74050120|NCT02545049|147652967|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Ratio of least squares means|0.676|||<|0.0001|TWO_SIDED|95.0|0.65|0.704||P-value from F-test of equal means between the treatment groups. A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|ANCOVA|||||0.704|0.650|<0.0001
74050121|NCT02545049|147652968|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.77||||0.0406|TWO_SIDED|95.0|0.6|0.99||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.99|0.60|0.0406
74050122|NCT01801189|147652969|SUPERIORITY|||||||0.1||||||Threshold for significance was P \<0.05.|t-test, 1 sided|||||||0.10
74050123|NCT01801189|147652969|SUPERIORITY|||||||0.23||||||Threshold for significance \<0.05|t-test, 1 sided|||POD 1||||.23
74050124|NCT01801189|147652969|SUPERIORITY|||||||0.31||||||Threshold for significance \<0.05|t-test, 1 sided|||POD 2||||.31
74050125|NCT00935766|147652995|SUPERIORITY_OR_OTHER|||||||0.21|||||||Mixed Models Analysis|||||||0.21
74050126|NCT00935766|147652996|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.08
74050127|NCT00935766|147652997|SUPERIORITY_OR_OTHER|||||||0.36|||||||Mixed Models Analysis|||||||0.36
74050128|NCT02200510|147653052|EQUIVALENCE|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.33||||0.575|TWO_SIDED||||||ANOVA|||||||0.575
74050129|NCT02200510|147653052|EQUIVALENCE|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.138||||0.721|TWO_SIDED||||||ANOVA|||||||0.721
74098785|NCT02472223|147746130|SUPERIORITY||Median Difference (Final Values)|90.0||||0.02|TWO_SIDED|||||p-value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.02
74098786|NCT04428333|147746196|SUPERIORITY|Other|Hazard Ratio (HR)|2.16||||0.74|TWO_SIDED|95.0|0.2|23.87||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and Human Papilloma Virus (HPV) status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||23.87|0.20|0.740
74098787|NCT04428333|147746197|SUPERIORITY|Other|Hazard Ratio (HR)|2.16||||0.74|TWO_SIDED|95.0|0.2|23.87||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥ 20 vs 1≤ CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||23.87|0.20|0.740
74050130|NCT03798366|147653088|SUPERIORITY||Least square (LS) mean difference|-0.5|STANDARD_ERROR_OF_MEAN|1.29||0.6757|TWO_SIDED|95.0|-3.1|2.0|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||2.0|-3.1|0.6757
74050131|NCT03798366|147653089|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|1.31||0.6079|TWO_SIDED|95.0|-3.3|1.9|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||1.9|-3.3|0.6079
74050132|NCT03798366|147653090|SUPERIORITY||LS mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.35||0.1298|TWO_SIDED|95.0|-4.8|0.6|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||0.6|-4.8|0.1298
74050133|NCT03798366|147653091|SUPERIORITY||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.36||0.0411|TWO_SIDED|95.0|-5.6|-0.1|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||-0.1|-5.6|0.0411
74050134|NCT00474539|147653095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (\>) -10%.|Difference|-0.5||||||95.0|-3.3|2.0||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at \>=1:8 titer was calculated||2.0|-3.3|
74050135|NCT00474539|147653098|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||1.08|0.69|
73881319|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|4.67||||0.0222|TWO_SIDED|95.0|1.25|17.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.47|1.25|0.0222
73881320|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4075|TWO_SIDED|95.0|0.54|4.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.65|0.54|0.4075
74050136|NCT00474539|147653098|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.23||||||95.0|0.97|1.55||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||1.55|0.97|
74050137|NCT00474539|147653099|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-3.5|2.0||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.0|-3.5|
74050138|NCT00474539|147653099|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.9|1.7||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||1.7|-1.9|
74050139|NCT00474539|147653099|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.2||||||95.0|-4.4|4.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||4.0|-4.4|
74050140|NCT00474539|147653099|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-2.1|2.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.0|-2.1|
74050141|NCT00474539|147653099|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.2|-2.2|
74050142|NCT00474539|147653099|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.2|-2.2|
74050143|NCT00474539|147653099|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.2|-2.3|
74050144|NCT00474539|147653099|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.2|-2.3|
74050145|NCT00474539|147653100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.72|1.03||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.03|0.72|
74050146|NCT00474539|147653100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.74|1.12||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.12|0.74|
74050147|NCT00474539|147653100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.93||||||95.0|0.78|1.1||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.78|
74050148|NCT00474539|147653100|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.24||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.24|0.81|
74050149|NCT00474539|147653103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.6||||||95.0|-1.7|3.2||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 1:8 titer was calculated.||3.2|-1.7|
74050150|NCT02061540|147653105|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.841|STANDARD_ERROR_OF_MEAN|6.0373||0.0043|TWO_SIDED|95.0|-27.251|-2.432|||Wilcoxon's signed rank test|||Analysis was performed to compare baseline and endpoint data.||-2.432|-27.251|0.0043
73881321|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3659|TWO_SIDED|95.0|0.56|4.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.93|0.56|0.3659
73881322|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7878|TWO_SIDED|95.0|0.41|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.24|0.41|0.7878
74050151|NCT02120469|147653185|OTHER||||||||||||||||||Dose level B1 (eribulin 1.1 mg/m2 days 1 and 8 every 3 weeks with everolimus 5 mg daily) was defined as the highest dose with acceptable toxicity (RP2D).|||
74050152|NCT01369069|147653256|SUPERIORITY||Risk Ratio (RR)|0.97||||0.55|TWO_SIDED|95.0|0.87|1.08||The a priori threshold for statistical significance was 0.05.|Regression, Logistic||Adjusted for baseline NIHSS strata (3-7, 8-14, 15-22) and thrombolysis use (Yes/No; includes both IV and IA therapies). Multiple imputation was used for missing data.|It was hypothesized that intensive blood glucose control would be efficacious and safe in acute ischemic stroke patients compared to standard glucose control.||1.08|0.87|0.55
74050153|NCT01369069|147653257|SUPERIORITY||Risk Difference (RD)|2.58|||<|0.001|TWO_SIDED|95.0|1.29|3.87|||Fisher Exact||The data of the estimation parameter and the confidence intervals were presented as percentages.|||3.87|1.29|<0.001
74050154|NCT01369069|147653258|SUPERIORITY||Risk Difference (RD)|-1.07||||0.77|TWO_SIDED|95.0|-8.33|6.2|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.|||6.20|-8.33|0.77
74050155|NCT01369069|147653259|SUPERIORITY||Risk Difference (RD)|0.48||||0.88|TWO_SIDED|95.0|-5.79|6.75|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.|||6.75|-5.79|0.88
74050156|NCT01369069|147653260|SUPERIORITY||Median Difference (Final Values)|0.06||||0.74|TWO_SIDED|95.0|-0.13|0.25|||Wilcoxon (Mann-Whitney)|||||0.25|-0.13|0.74
74050157|NCT01369069|147653261|SUPERIORITY||Risk Ratio (RR)|0.82||||0.24|TWO_SIDED|95.0|0.58|1.15|||Chi-squared|||||1.15|0.58|0.24
74050158|NCT01846208|147653269|SUPERIORITY||Risk Difference (RD)|32.4||||0.009|TWO_SIDED|95.0|8.9|55.8|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Baked vs. Egg OIT-Randomized||55.8|8.9|0.009
74050159|NCT01846208|147653269|SUPERIORITY||Risk Difference (RD)|25.5||||0.031|TWO_SIDED|95.0|2.0|49.1|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||49.1|2.0|0.031
74050160|NCT01846208|147653270|SUPERIORITY||Risk Difference (RD)|64.7|||<|0.0001|TWO_SIDED|95.0|43.9|85.6|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 2 OFC: Baked vs. Egg OIT-Randomized||85.6|43.9|<0.0001
74098788|NCT04428333|147746198|SUPERIORITY|Other|Hazard Ratio (HR)|0.7||||0.284|TWO_SIDED|95.0|0.2|2.43||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.43|0.20|0.284
74098789|NCT04428333|147746199|SUPERIORITY|Other|Hazard Ratio (HR)|0.7||||0.284|TWO_SIDED|95.0|0.2|2.43||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.43|0.20|0.284
74050161|NCT01846208|147653270|SUPERIORITY||Risk Difference (RD)|17.7||||0.151|TWO_SIDED|95.0|-2.3|37.7|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 2 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||37.7|-2.3|0.151
74050162|NCT01846208|147653270|SUPERIORITY||Risk Difference (RD)|44.3||||0.002|TWO_SIDED|95.0|19.4|69.2|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 1 OFC: Baked vs. Egg OIT-Randomized||69.2|19.4|0.002
74050163|NCT01846208|147653270|SUPERIORITY||Risk Difference (RD)|17.5||||0.181|TWO_SIDED|95.0|-6.3|41.3|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 1 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||41.3|-6.3|0.181
74050164|NCT01846208|147653272|SUPERIORITY||Risk Difference (RD)|-50.2||||0.003|TWO_SIDED|95.0|-78.4|-21.9|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Baked vs. Egg OIT-Randomized||-21.9|-78.4|0.003
74050165|NCT01846208|147653272|SUPERIORITY||Risk Difference (RD)|33.7||||0.023|TWO_SIDED|95.0|7.2|60.1|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Egg OIT-Randomized vs. Egg OIT-Assigned||60.1|7.2|0.023
74050166|NCT01424306|147653274|OTHER|||||||0.403||||||P value for the time x diet interaction reflects overall comparison of 3 dietary phases by RM-ANOVA|RM-ANOVA|||RM-ANOVA||||0.403
74050167|NCT01424306|147653275|OTHER|RM-ANOVA||||||0.933||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.933
74050168|NCT01424306|147653276|OTHER|RM-ANOVA||||||0.196||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.196
74050169|NCT01424306|147653277|OTHER|RM-ANOVA||||||0.88||||||Reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.880
74050170|NCT01424306|147653278|OTHER|RM-ANOVA|||||<|0.001||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|Repeated measures ANOVA|||||||<0.001
74050171|NCT01424306|147653279|OTHER|RM-ANOVA||||||0.366||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.366
74050172|NCT01424306|147653280|OTHER|RM-ANOVA||||||0.387||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.387
74050173|NCT01424306|147653281|OTHER|RM-ANOVA||||||0.476||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.476
74050174|NCT01424306|147653282|OTHER|RM-ANOVA||||||0.596||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.596
74050175|NCT01424306|147653283|OTHER|RM-ANOVA||||||0.492||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.492
74050176|NCT01424306|147653284|OTHER|RM-ANOVA||||||0.149||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.149
74050177|NCT01424306|147653285|OTHER|RM-ANOVA||||||0.056||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.056
74050178|NCT01424306|147653286|OTHER|RM-ANOVA||||||0.52||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.520
74050179|NCT00369928|147653290|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.88||||0.982|TWO_SIDED|80.0|0.56|1.38|||Cochran-Mantel-Haenszel|||||1.38|0.56|0.982
74018875|NCT01337973|147590077|SUPERIORITY||coefficient estimate|0.84|||<|0.05|TWO_SIDED|95.0|0.54|1.32||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.48|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||1.32|0.54|<0.05
74018876|NCT01337973|147590077|SUPERIORITY||coefficient estimate|1.15|||<|0.001|TWO_SIDED|95.0|0.78|1.71||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.94|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||1.71|0.78|<0.001
74018877|NCT01337973|147590077|SUPERIORITY||coefficient estimate|0.61|||<|0.05|TWO_SIDED|95.0|0.17|2.16||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.56|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||2.16|0.17|<0.05
74018878|NCT01337973|147590077|SUPERIORITY||coefficient estimate|1.18|||<|0.01|TWO_SIDED|95.0|0.57|2.44||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.86|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||2.44|0.57|<0.01
74018879|NCT01337973|147590077|SUPERIORITY||coefficient estimate|0.95|||<|0.001|TWO_SIDED|95.0|0.61|1.48||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.51|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||1.48|0.61|<0.001
74018880|NCT01337973|147590077|SUPERIORITY||||||<|0.001||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.65||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||||<0.001
74018881|NCT01337973|147590077|SUPERIORITY||||||>|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.45||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||||>0.05
74018882|NCT01337973|147590077|SUPERIORITY||||||>|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.5||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||||>0.05
74018883|NCT01337973|147590077|SUPERIORITY||||||<|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.58||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||||<0.05
74018884|NCT02167945|147590108|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
74018885|NCT02167945|147590108|SUPERIORITY||Cox Proportional Hazard Ratio|0.126|||<|0.001|TWO_SIDED|95.0|0.044|0.358|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.358|0.044|<0.001
74018886|NCT02167945|147590109|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
74018887|NCT02167945|147590109|SUPERIORITY||Cox Proportional Hazard Ratio|0.031||||0.007|TWO_SIDED|95.0|0.003|0.38|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.380|0.003|0.007
74018888|NCT02167945|147590110|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
74050180|NCT00369928|147653290|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.79||||0.666|TWO_SIDED|80.0|0.5|1.25|||Cochran-Mantel-Haenszel|||||1.25|0.50|0.666
74050181|NCT01809327|147653295|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.657|-0.269|||Mixed Model for Repeated Measures (MMRM)|||||-0.269|-0.657|0.001
74050182|NCT01809327|147653295|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.67|-0.28|||Mixed Model for Repeated Measures (MMRM)|||||-0.280|-0.670|0.001
73881323|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0635|TWO_SIDED|95.0|0.94|11.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||11.38|0.94|0.0635
73881324|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|14.62||||0.0137|TWO_SIDED|95.0|1.73|123.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||123.3|1.73|0.0137
73881325|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1069|TWO_SIDED|95.0|0.79|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.62|0.79|0.1069
73881326|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|5.6||||0.0186|TWO_SIDED|95.0|1.33|23.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||23.47|1.33|0.0186
73881327|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1434|TWO_SIDED|95.0|0.75|7.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.56|0.75|0.1434
74050183|NCT01809327|147653295|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.594|-0.207|||Mixed Model for Repeated Measures (MMRM)|||||-0.207|-0.594|0.001
74050184|NCT01809327|147653295|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.557|-0.169|||Mixed Model for Repeated Measures (MMRM)|||||-0.169|-0.557|0.001
74050185|NCT01809327|147653295|NON_INFERIORITY_OR_EQUIVALENCE|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.258|0.133|||Mixed Model for Repeated Measures (MMRM)|||||0.133|-0.258|0.001
74050186|NCT01809327|147653295|NON_INFERIORITY_OR_EQUIVALENCE|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.307|0.082|||Mixed Model for Repeated Measures (MMRM)|||||0.082|-0.307|0.001
74050187|NCT01809327|147653296|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.016|TWO_SIDED|95.0|-1.6|-0.2|||Mixed Model for Repeated Measures (MMRM)|||||-0.2|-1.6|0.016
74098790|NCT04428333|147746202|OTHER||Difference in Percentage|-4.8|||||TWO_SIDED|95.0|-20.8|11.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||11.3|-20.8|
74050188|NCT01809327|147653296|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.4||0.002|TWO_SIDED|95.0|-2.6|-1.1|||Mixed Model for Repeated Measures (MMRM)|||||-1.1|-2.6|0.002
74050189|NCT01809327|147653296|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Model for Repeated Measures (MMRM)|||||-0.6|-2.1|0.001
73881328|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.2||||0.167|TWO_SIDED|95.0|0.72|6.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.75|0.72|0.1670
73881329|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.16||||0.781|TWO_SIDED|95.0|0.41|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.28|0.41|0.7810
73881330|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.27||||0.1682|TWO_SIDED|95.0|0.71|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.26|0.71|0.1682
73881331|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|5.22||||0.0215|TWO_SIDED|95.0|1.28|21.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||21.39|1.28|0.0215
73881332|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|4.75||||0.0306|TWO_SIDED|95.0|1.16|19.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||19.52|1.16|0.0306
74050190|NCT01809327|147653296|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.9|-1.4|||Mixed Model for Repeated Measures (MMRM)|||||-1.4|-2.9|0.001
74050191|NCT01809327|147653297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.027|TWO_SIDED|95.0|1.06|2.37|||Generalized Linear Mixed Model|||||2.37|1.06|0.027
74050192|NCT01809327|147653297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.016|TWO_SIDED|95.0|1.46|3.33|||Generalized Linear Mixed Model|||||3.33|1.46|0.016
74050193|NCT01809327|147653298|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.882||0.06|TWO_SIDED|95.0|-3.641|-0.182|||Mixed Model for Repeated Measures (MMRM)|||||-0.182|-3.641|0.060
73881333|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|10.1||||0.0059|TWO_SIDED|95.0|1.92|52.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||52.29|1.92|0.0059
73881334|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.64||||0.1004|TWO_SIDED|95.0|0.83|8.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.43|0.83|0.1004
74050194|NCT01809327|147653298|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.889||0.147|TWO_SIDED|95.0|-3.058|0.431|||Mixed Model for Repeated Measures (MMRM)|||||0.431|-3.058|0.147
74050195|NCT01809327|147653299|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|2.1||0.147|TWO_SIDED|95.0|1.2|9.5|||ANCOVA|||||9.5|1.2|0.147
74050196|NCT01809327|147653299|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|2.1||0.147|TWO_SIDED|95.0|0.2|8.5|||ANCOVA|||||8.5|0.2|0.147
74050197|NCT01809327|147653300|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|-3.7||||0.608|TWO_SIDED|95.0|-11.1|3.4|||Wilcoxon (Mann-Whitney)|||||3.4|-11.1|0.608
74050198|NCT01809327|147653300|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|1.3||||0.806|TWO_SIDED|95.0|-7.3|10.0|||Wilcoxon (Mann-Whitney)|||||10.0|-7.3|0.806
74050199|NCT02176005|147653317|OTHER||Contrast (B/A)|0.0093|||<|1e-06|TWO_SIDED|95.0|0.006|0.0144|||General linear model|||||0.0144|0.0060|<.000001
74050200|NCT02176005|147653318|OTHER||Contrast (B/A)|0.0096|||<|1e-06|TWO_SIDED|95.0|0.0061|0.0151|||General linear model|||||0.0151|0.0061|<.000001
74050201|NCT02176005|147653319|OTHER||Contrast (B/A)|0.9811||||0.806|TWO_SIDED|95.0|0.8608|1.1182|||General linear model|||||1.1182|0.8608|0.806
74050202|NCT02176005|147653320|OTHER||Contrast (B/A)|0.8785||||0.139|TWO_SIDED|95.0|0.76|1.0155|||General linear model|||||1.0155|0.7600|0.139
74050203|NCT02176005|147653321|OTHER||Contrast (B/A)|1.1763||||0.104|TWO_SIDED|95.0|0.9982|1.3861|||General linear model|||||1.3861|0.9982|0.104
74050204|NCT02176005|147653322|OTHER||Contrast (B/A)|0.9391||||0.519|TWO_SIDED|95.0|0.7969|1.1066|||General linear model|||||1.1066|0.7969|0.519
74050205|NCT04957745|147653330|OTHER||||||<|0.01||||||"Null hypothesis is that there is no difference in Percentage of Total Viewing Time that Peripheral Target is Perceived across visual confusion conditions."|ANOVA|||"Effect of visual confusion conditions (binocular, unilateral monocular, and bilateral monocular visual confusions) on Percentage of Total Viewing Time Peripheral Target is Perceived is analyzed by repeated measure (within-subject) ANOVA. The test was performed with a significance level of 0.05."||||<0.01
74050206|NCT02274766|147653357|SUPERIORITY||Least Squares Mean Difference|-14.4|STANDARD_ERROR_OF_MEAN|3.03|<|0.0001|TWO_SIDED|95.0|-20.4|-8.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable; the baseline value is a continuous covariate||32 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.||-8.3|-20.4|<0.0001
74050207|NCT02274766|147653358|SUPERIORITY||Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.775||0.0168|TWO_SIDED|95.0|0.35|3.45||Change from Baseline in ON time without troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures|||||3.45|0.35|0.0168
74050208|NCT02274766|147653358|SUPERIORITY||Least Squares Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.648||0.0853|TWO_SIDED|95.0|-2.42|0.16||Change from Baseline in ON time with troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures|||||0.16|-2.42|0.0853
74098791|NCT04428333|147746203|OTHER||Difference in Percentage|-5.1|||||TWO_SIDED|95.0|-21.4|11.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||11.3|-21.4|
73881335|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1837|TWO_SIDED|95.0|0.7|6.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.36|0.70|0.1837
73881336|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5929|TWO_SIDED|95.0|0.47|3.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.75|0.47|0.5929
74050209|NCT02274766|147653358|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.461||0.0199|TWO_SIDED|95.0|-2.02|-0.18||Change from Baseline in OFF time.|Linear Mixed Model w/ Repeated Measures|||||-0.18|-2.02|0.0199
74050210|NCT00281528|147653370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4476||95.0||||Group comparison was performed between group 260 mg/m\^2 ABI-007 every 3 weeks and group 130 mg/m\^2 ABI-007 weekly, as based on amended protocol, no type I error adjustment for multiplicity; a priori threshold for statistical significance is 0.05.|Cochran-Mantel-Haenszel|Stratified by study site||||||0.4476
74050211|NCT04396106|147653383|OTHER|||||||0.721|||||||Cochran-Mantel-Haenszel|||||||0.721
74050212|NCT01628718|147653391|NON_INFERIORITY|The NI margin for CAPS-IV scores was established a priori, based on a calculation of a reliable difference from baseline to posttreatment CAPS-IV scores from a previous trial (10 points). If the 95% confidence interval (CI) around the estimate does not contain the NI margin, we can reject the null hypothesis and accept the alternative hypothesis. .|Mean Difference (Final Values)|0.33||||0.05|TWO_SIDED|95.0|-10.1|9.44||one-tailed|Regression, Linear||Mean difference is the difference in mean CAPS-IV change scores (pre-post) between AD and CPT-C.|Null hypothesis: AD is inferior to CPT Alternative hypothesis: AD is non-inferior to CPT-C||9.44|-10.10|.05
74050213|NCT02313506|147653392|SUPERIORITY||Mean Difference (Net)|-31.1||||0.02|TWO_SIDED|95.0|-56.6|-5.7||No adjustment was made for multiple comparisons because Type II error is a greater concern than Type I error in feasibility studies.|ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 1 compared T0-T1 between the 2 groups to determine if the intervention was superior to the control.||-5.7|-56.6|0.02
74050214|NCT02313506|147653392|SUPERIORITY||Mean Difference (Net)|4.6||||0.71|TWO_SIDED|95.0|-19.6|28.9|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 2 compared T0-T1 in the immediate group against T1-T2 in the delayed group.||28.9|-19.6|0.71
74050215|NCT02313506|147653392|SUPERIORITY||Mean Difference (Net)|-11.0||||0.29|TWO_SIDED|95.0|-31.1|9.1|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 3 compared T0-T1 in the immediate group against T0-T2 in the delayed group.||9.1|-31.1|0.29
74050216|NCT01436357|147653413|SUPERIORITY||Hazard Ratio (HR)|1.529||||0.317|TWO_SIDED|95.0|0.661|3.535|||Regression, Cox|||||3.535|0.661|0.317
74050217|NCT01436357|147653414|SUPERIORITY||Risk Difference (RD)|0.08||||0.029|TWO_SIDED|95.0|-0.01|0.16|||Fisher Exact|||||0.16|-0.01|0.029
74050218|NCT01436357|147653415|SUPERIORITY||Risk Difference (RD)|0.1||||0.015|TWO_SIDED|95.0|0.01|0.2|||Fisher Exact|||||0.20|0.01|0.015
74050219|NCT01436357|147653416|SUPERIORITY||Risk Difference (RD)|0.0||||0|TWO_SIDED||||||Fisher Exact|||||||0.00
74050220|NCT01436357|147653418|SUPERIORITY||Risk Difference (RD)|0.01||||0.499|TWO_SIDED|95.0|-0.08|0.1|||Fisher Exact|||||0.10|-0.08|0.499
74050221|NCT03958149|147653432|SUPERIORITY||||||<|0.001|||||||Independent t-test|||||||<0.001
74050222|NCT03958149|147653433|SUPERIORITY||||||<|0.05|||||||Factorial Mixed ANOVA|||||||<0.05
74050223|NCT03350724|147653460|SUPERIORITY|||||||0.039||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.039
74050224|NCT03350724|147653461|SUPERIORITY|||||||0.037||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.037
74098792|NCT04428333|147746204|OTHER||Difference in Percentage|-4.8|||||TWO_SIDED|95.0|-22.2|13.1||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||13.1|-22.2|
74098793|NCT04428333|147746205|OTHER||Difference in Percentage|-5.1|||||TWO_SIDED|95.0|-22.8|13.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||13.3|-22.8|
74098794|NCT04428333|147746222|SUPERIORITY|Other|Hazard Ratio (HR)|0.85||||0.329|TWO_SIDED|95.0|0.42|1.71||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.71|0.42|0.329
74050225|NCT03350724|147653462|SUPERIORITY|||||||0.032|||||||Z-Test for Two Population Proportions|||||||0.032
74050226|NCT03350724|147653463|SUPERIORITY|||||||0.171||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.171
74050227|NCT03350724|147653464|SUPERIORITY|||||||0.484||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.484
74050228|NCT03350724|147653465|SUPERIORITY|||||||0.368||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.368
74050229|NCT03350724|147653466|SUPERIORITY|||||||0.308||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.308
74050230|NCT03350724|147653467|SUPERIORITY|||||||0.999||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.999
74050231|NCT03350724|147653468|SUPERIORITY|||||||0.015||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.015
74050232|NCT03350724|147653469|SUPERIORITY|||||||0.021||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.021
74050233|NCT03350724|147653470|SUPERIORITY|||||||0.035||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.035
74050234|NCT03350724|147653471|SUPERIORITY|||||||0.444||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.444
74050235|NCT03350724|147653472|SUPERIORITY|||||||0.765||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.765
74050236|NCT03350724|147653473|SUPERIORITY|||||||0.941||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.941
74050237|NCT03350724|147653474|SUPERIORITY|||||||0.421||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.421
74050238|NCT03350724|147653475|SUPERIORITY|||||||0.357||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.357
74050239|NCT03350724|147653476|SUPERIORITY|||||||0.22||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.22
74050240|NCT03350724|147653477|SUPERIORITY|||||||0.882||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.882
74050241|NCT03350724|147653478|SUPERIORITY|||||||0.64||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.64
74050242|NCT03350724|147653479|SUPERIORITY|||||||0.967||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.967
74050243|NCT03350724|147653480|SUPERIORITY|||||||0.375||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.375
74050244|NCT02759939|147653491|SUPERIORITY||Odds Ratio (OR)|1.23||||0.8|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.80
73881337|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.93||||0.2588|TWO_SIDED|95.0|0.62|6.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.07|0.62|0.2588
74050245|NCT02759939|147653491|SUPERIORITY||Odds Ratio (OR)|1.47||||0.32|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.32
74018889|NCT02167945|147590110|SUPERIORITY||Cox Proportional Hazard Ratio|0.038|||<|0.001|TWO_SIDED|95.0|0.009|0.156|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.156|0.009|<0.001
74018890|NCT02167945|147590111|SUPERIORITY|||||||0.86|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.860
74018891|NCT02167945|147590111|SUPERIORITY|||||||0.997||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.997
74018892|NCT02167945|147590112|SUPERIORITY|||||||0.608|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.608
74018893|NCT02167945|147590112|SUPERIORITY|||||||0.992||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.992
74018894|NCT02167945|147590113|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
74018895|NCT02167945|147590113|SUPERIORITY||Cox Proportional Hazard Ratio|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.313|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.313|0.057|<0.001
74018896|NCT02167945|147590115|SUPERIORITY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.79||0.026|TWO_SIDED|95.0|-3.3|-0.21|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.21|-3.30|0.026
74018897|NCT02167945|147590115|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.74||0.472|TWO_SIDED|95.0|-1.97|0.91|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.91|-1.97|0.472
74018898|NCT02167945|147590115|SUPERIORITY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.73||0.159|TWO_SIDED|95.0|-2.47|0.4|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.40|-2.47|0.159
74018899|NCT02167945|147590115|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.84||0.125|TWO_SIDED|95.0|-2.95|0.36|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.36|-2.95|0.125
74018900|NCT02167945|147590115|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.78||0.756|TWO_SIDED|95.0|-1.78|1.29|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.29|-1.78|0.756
74018901|NCT02167945|147590115|SUPERIORITY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.78||0.315|TWO_SIDED|95.0|-2.32|0.75|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.75|-2.32|0.315
74098795|NCT04428333|147746223|SUPERIORITY|Other|Hazard Ratio (HR)|0.82||||0.302|TWO_SIDED|95.0|0.4|1.69||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.69|0.40|0.302
74050246|NCT02759939|147653491|SUPERIORITY||Odds Ratio (OR)|0.95||||0.99|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.99
74050247|NCT02759939|147653491|SUPERIORITY||Odds Ratio (OR)|0.8||||0.72|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.72
74050248|NCT03347279|147653563|SUPERIORITY||Rate Ratio|0.44|||<|0.001|TWO_SIDED|95.0|0.37|0.53|||Negative Binomial|||||0.53|0.37|<0.001
74050249|NCT03347279|147653564|SUPERIORITY||Rate Ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.46|0.75|||Negative Binomial|||||0.75|0.46|<0.001
74050250|NCT03347279|147653565|SUPERIORITY||Least Squares (LS) Mean Difference|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.18|||Mixed Models Analysis|||||0.18|0.08|<0.001
74050251|NCT03347279|147653566|SUPERIORITY||LS Means Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.2|0.47|||Mixed Models Analysis|||||0.47|0.2|<0.001
74050252|NCT03347279|147653567|SUPERIORITY||LS Means Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.46|-0.2|||Mixed Models Analysis|||||-0.2|-0.46|<0.001
74050253|NCT03347279|147653568|SUPERIORITY||LS Means Difference|-0.11||||0.004|TWO_SIDED|95.0|-0.19|-0.04|||Mixed Models Analysis|||||-0.04|-0.19|0.004
74050254|NCT02530281|147653620|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74050255|NCT02530281|147653621|OTHER||||||=|0.065|||||||ANCOVA|Ranked ANCOVA||||||=0.065
74050256|NCT02530281|147653622|OTHER||||||=|0.065|||||||ANCOVA|Ranked ANCOVA||||||=0.065
74098796|NCT04428333|147746224|SUPERIORITY|Other|Hazard Ratio (HR)|0.96||||0.472|TWO_SIDED|95.0|0.44|2.11||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.11|0.44|0.472
74050257|NCT02530281|147653623|OTHER||||||=|0.001|||||||ANCOVA|Ranked ANCOVA||||||=0.001
74050258|NCT02530281|147653624|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74050259|NCT02530281|147653625|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74050260|NCT00535236|147653626|OTHER||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||<0.001
74050261|NCT00535236|147653626|OTHER|||||||0.003||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.003
74050262|NCT00535236|147653626|OTHER|||||||0.017||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.017
74050263|NCT00535236|147653627|OTHER||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjustied for prevaccination values||||||<0.001
74050264|NCT00535236|147653627|OTHER|||||||0.004||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.004
74050265|NCT00535236|147653627|OTHER|||||||0.026||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.026
74050266|NCT00535236|147653628|OTHER||Difference in Percentages|12.5|||||TWO_SIDED|95.0|-21.7|35.3|||||V212 minus placebo = Difference|||35.3|-21.7|
74050267|NCT00535236|147653628|OTHER||Difference in Percentages|10.0|||||TWO_SIDED|95.0|-15.1|42.9|||||V212 minus placebo = Difference|||42.9|-15.1|
74050268|NCT00535236|147653628|OTHER||Difference in Percentages|1.8|||||TWO_SIDED|95.0|-20.4|15.7|||||V212 minus placebo = Difference|||15.7|-20.4|
74050269|NCT00535236|147653628|OTHER||Difference in Percentages|14.4|||||TWO_SIDED|95.0|-6.5|27.6|||||V212 minus placebo = Difference|||27.6|-6.5|
74050270|NCT00535236|147653628|OTHER||Difference in Percentages|3.3|||||TWO_SIDED|95.0|-18.1|17.0|||||V212 minus placebo = Difference|||17.0|-18.1|
74050271|NCT00535236|147653629|OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-31.7|16.5|||Asymptotic method||V212 minus placebo = Difference|||16.5|-31.7|>0.999
74050272|NCT00535236|147653629|OTHER||Difference in Percentages|10.0||||0.302|TWO_SIDED|95.0|-18.8|23.2|||Asymptotic method||V212 minus placebo = Difference|||23.2|-18.8|0.302
74050273|NCT00535236|147653629|OTHER||Difference in Percentages|31.6||||0.009|TWO_SIDED|95.0|9.7|46.2|||Asymptotic method||V212 minus placebo = Difference|||46.2|9.7|0.009
74050274|NCT00535236|147653629|OTHER||Difference in Percentages|22.6||||0.041|TWO_SIDED|95.0|1.3|36.6|||Asymptotic method||V212 minus placebo = Difference|||36.6|1.3|0.041
74050275|NCT00535236|147653629|OTHER||Difference in Percentages|-11.7||||0.064|TWO_SIDED|95.0|-33.2|0.6|||Asymptotic method||V212 minus placebo = Difference|||0.6|-33.2|0.064
74050276|NCT00535236|147653630|OTHER||Difference in Percentages|-5.0||||0.556|TWO_SIDED|95.0|-36.3|9.5|||Asymptotic method||V212 minus placebo = Difference|||9.5|-36.3|0.556
74098797|NCT04428333|147746225|SUPERIORITY|Other|Hazard Ratio (HR)|0.83||||0.335|TWO_SIDED|95.0|0.36|1.9||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.90|0.36|0.335
74098798|NCT04853992|147746226|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.5||0.277|TWO_SIDED|95.0|-1.69|0.53|||Mixed Models Analysis|||The primary endpoint, change from baseline in post-provocation Urticaria Activity Score (UASprovo) to the end of the treatment period, was compared between treatments with the null hypothesis that they are equal against the alternative that they are different. The primary efficacy endpoint was analysed using a linear mixed model, containing treatment, period and carryover effects, the factor site and additionally the value of UASprovo at baseline as a covariate.||0.53|-1.69|0.277
74098799|NCT03582826|147746231|SUPERIORITY|Paired Wilcoxon Signed-Rank Tests|Median Difference (Final Values)|79.0||||0.02|TWO_SIDED|95.0|26.0|163.0||Original p-value for dermatological bacteria was 6e-05. It was adjusted first by applying centered log-ratio (CLR) transformation approach then by false discovery rate (FDR) correction for multiple comparisons by using Benjamini-Hochberg Procedure.|Wilcoxon (Mann-Whitney)|||||163|26|0.02
74098800|NCT03480386|147746237|SUPERIORITY|||||||0.0788|||||||t-test, 2 sided|||Daily Light Physical Activity||||0.0788
74098801|NCT03480386|147746237|SUPERIORITY|||||||0.0742|||||||t-test, 2 sided|||Daily Moderate Physical Activity||||0.0742
74098802|NCT03480386|147746238|SUPERIORITY|||||||0.0113|||||||t-test, 2 sided|||||||0.0113
74098803|NCT03480386|147746239|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
74098804|NCT03480386|147746240|SUPERIORITY|||||||0.2216|||||||t-test, 2 sided|||||||0.2216
74098805|NCT03480386|147746241|SUPERIORITY|||||||0.4762|||||||t-test, 2 sided|||||||0.4762
74098806|NCT03480386|147746242|SUPERIORITY|||||||0.0068|||||||t-test, 2 sided|||||||0.0068
74098807|NCT03480386|147746243|SUPERIORITY|||||||0.1548|||||||t-test, 2 sided|||||||0.1548
74098808|NCT00574912|147746245|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74098809|NCT00469911|147746246|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74098810|NCT02629354|147746247|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|113.77|||||TWO_SIDED|90.0|98.99|130.75|||ANOVA||Analysis of variance (ANOVA) with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% confidence interval (CI) was provided.||130.75|98.99|
73888118|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.8||||0.1597|TWO_SIDED|95.0|-124.2|20.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.6|-124.2|0.1597
74098811|NCT02629354|147746248|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|110.16|||||TWO_SIDED|90.0|96.32|125.97|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||125.97|96.32|
74098812|NCT02629354|147746249|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|112.69|||||TWO_SIDED|90.0|98.49|128.94|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||128.94|98.49|
74098813|NCT02629354|147746250|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.36|||||TWO_SIDED|90.0|94.61|100.19|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.19|94.61|
74098814|NCT02629354|147746251|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|96.47|||||TWO_SIDED|90.0|93.74|99.28|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||99.28|93.74|
74098815|NCT02629354|147746252|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.55|||||TWO_SIDED|90.0|92.57|102.8|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||102.80|92.57|
74098816|NCT02629354|147746253|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.57|||||TWO_SIDED|90.0|94.5|100.73|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.73|94.50|
74050277|NCT00535236|147653630|OTHER||Difference in Percentages|2.5||||0.617|TWO_SIDED|95.0|-25.8|13.0|||Asymptotic method||V212 minus placebo = Difference|||13.0|-25.8|0.617
74050278|NCT00535236|147653630|OTHER||Difference in Percentages|3.5||||0.411|TWO_SIDED|95.0|-13.7|12.0|||Asymptotic method||V212 minus placebo = Difference|||12.0|-13.7|0.411
74050279|NCT00535236|147653630|OTHER||Difference in Percentages|4.9||||0.328|TWO_SIDED|95.0|-12.3|13.6|||Asymptotic method||V212 minus placebo = Difference|||13.6|-12.3|0.328
74050280|NCT00535236|147653630|OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-19.2|10.0|||Asymptotic method||V212 minus placebo = Difference|||10.0|-19.2|>0.999
74050281|NCT00535236|147653631|OTHER||Difference in Percentages|10.5||||0.552|TWO_SIDED|95.0|-21.3|41.8|||Asymptotic method||V212 minus placebo = Difference|||41.8|-21.3|0.552
74050282|NCT00535236|147653631|OTHER||Difference in Percentages|6.7||||0.696|TWO_SIDED|95.0|-22.5|39.4|||Asymptotic method||V212 minus placebo = Difference|||39.4|-22.5|0.696
74050283|NCT00535236|147653631|OTHER||Difference in Percentages|7.5||||0.221|TWO_SIDED|95.0|-9.8|18.0|||Asymptotic method||V212 minus placebo = Difference|||18.0|-9.8|0.221
74050284|NCT00535236|147653631|OTHER||Difference in Percentages|6.8||||0.402|TWO_SIDED|95.0|-13.7|19.1|||Asymptotic method||V212 minus placebo = Difference|||19.1|-13.7|0.402
74050285|NCT00535236|147653631|OTHER||Difference in Percentages|3.8||||0.679|TWO_SIDED|95.0|-18.5|18.2|||Asymptotic method||V212 minus placebo = Difference|||18.2|-18.5|0.679
74098817|NCT02629354|147746254|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.21|||||TWO_SIDED|90.0|92.22|102.46|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||102.46|92.22|
74098818|NCT02629354|147746255|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|96.83|||||TWO_SIDED|90.0|93.75|100.01|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.01|93.75|
74098819|NCT04308226|147746278|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74050286|NCT03288987|147653638|NON_INFERIORITY|Noninferiority was declared by comparing the 90% CI for the hazard ratio (HR) of the AryoGen Pharmed Bevacizumab to the reference product (Roche Bevacizumab) to the point-estimate margin and was based on the synthesis method.|Hazard Ratio (HR)|0.79||||0.47|TWO_SIDED|90.0|0.46|1.35|||Regression, Cox|Upper limit of CI is lower than the noninferiority margin (1.44).|The 90 % CI based on synthesis method is (0.45,1.38). In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.35|0.46|0.47
74098820|NCT04308226|147746280|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
74098821|NCT05307510|147746281|SUPERIORITY|Statistical analysis is under powered. N is too low.||||||0.135||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain at rest||||0.135
74098822|NCT05307510|147746281|SUPERIORITY|Statistical analysis is underpowered. N is too low||||||0.716||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain at Night||||.716
74098823|NCT05307510|147746281|SUPERIORITY|Statistical Analysis underpowered. N is too small.||||||0.509||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain in use||||.509
74098824|NCT05307510|147746282|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
74050287|NCT03288987|147653639|OTHER||Hazard Ratio (HR)|0.99||||0.99|TWO_SIDED|95.0|0.55|1.8|||Regression, Cox||In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.80|0.55|0.99
74098825|NCT05307510|147746283|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.635||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Palmar abduction of surgical hand||||.635
74098826|NCT05307510|147746283|SUPERIORITY|Statistical analysis is underpowered. N is too low.|Mean Difference (Net)|-3.1||||0.521|TWO_SIDED|95.0|-13.6|7.4|||t-test, 2 sided|||Radial Abduction Surgical Hand||7.4|-13.6|.521
74050288|NCT03288987|147653640|OTHER|||||||0.17|||||||Fisher's Exact Test|||||||0.17
74050289|NCT03288987|147653641|OTHER||Hazard Ratio (HR)|1.11||||0.59|TWO_SIDED|95.0|0.76|1.61|||Regression, Cox||In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.61|0.76|0.59
74050290|NCT03288987|147653642|OTHER||||||>|0.05|||||||Fisher's Exact Test|||||||>0.05
74050291|NCT01072500|147653657|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.03|TWO_SIDED|95.0|0.69|0.98|||Regression, Cox|To compare interventions, we used a likelihood ratio test from a Cox regression model, stratified by field center and sex.||||0.98|0.69|0.03
74050292|NCT01072500|147653658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.006|TWO_SIDED|95.0|0.57|0.91|||Regression, Cox|||||0.91|0.57|0.006
74050293|NCT01642004|147653662|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.0002|TWO_SIDED|96.85|0.43|0.81||Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).|Log Rank||Stratified Cox proportional hazard model. HR = Nivolumab over Docetaxel|||0.81|0.43|0.0002
74050294|NCT02584660|147653739|SUPERIORITY||Mean difference|-1.202|||<|0.0001|TWO_SIDED|95.0|-1.73|-0.674|||t-test|||||-0.674|-1.730|<.0001
74050295|NCT03099304|147653747|SUPERIORITY||Odds Ratio (OR)|13.79||||0.0057|TWO_SIDED|95.0|1.73|640.85||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||640.85|1.73|0.0057
74050296|NCT03099304|147653747|SUPERIORITY||Odds Ratio (OR)|10.3||||0.0243|TWO_SIDED|95.0|1.24|487.28||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||487.28|1.24|0.0243
74050297|NCT03099304|147653747|SUPERIORITY||Odds Ratio (OR)|28.48|||<|0.0001|TWO_SIDED|95.0|3.74|1305.2||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||1305.2|3.74|<0.0001
74050298|NCT03099304|147653747|SUPERIORITY||Odds Ratio (OR)|24.66||||0.0001|TWO_SIDED|95.0|3.28|1121.4||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||1121.4|3.28|0.0001
74050299|NCT03099304|147653748|SUPERIORITY||Odds Ratio (OR)|1.03||||0.4936|TWO_SIDED|95.0|0.05||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.05|0.4936
74050300|NCT03099304|147653748|SUPERIORITY||Odds Ratio (OR)|4.16||||0.114|TWO_SIDED|95.0|0.62||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.62|0.1140
74050301|NCT03099304|147653748|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0501|TWO_SIDED|95.0|1.0||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||1.00|0.0501
74050302|NCT03099304|147653748|SUPERIORITY||Odds Ratio (OR)|3.89||||0.1257|TWO_SIDED|95.0|0.58||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.58|0.1257
74050303|NCT03099304|147653749|SUPERIORITY||Odds Ratio (OR)|1.19||||0.9794|TWO_SIDED|95.0|0.33|4.33|||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).||||4.33|0.33|0.9794
74050304|NCT03099304|147653749|SUPERIORITY||Odds Ratio (OR)|1.69||||0.4893|TWO_SIDED|95.0|0.51|5.86|||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).||||5.86|0.51|0.4893
74050305|NCT03099304|147653756|SUPERIORITY||Least squares mean (LSM) difference|-0.44|STANDARD_ERROR_OF_MEAN|0.16||0.0056|TWO_SIDED|95.0|-0.75|-0.13|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.13|-0.75|0.0056
74050306|NCT03099304|147653756|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0095|TWO_SIDED|95.0|-0.7|-0.1|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.10|-0.70|0.0095
74050307|NCT03099304|147653756|SUPERIORITY||LSM difference|-0.68|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.37|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.37|-0.99|<0.0001
74050308|NCT03099304|147653756|SUPERIORITY||LSM difference|-0.51|STANDARD_ERROR_OF_MEAN|0.15||0.0011|TWO_SIDED|95.0|-0.8|-0.21|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.21|-0.80|0.0011
74050309|NCT03099304|147653758|SUPERIORITY||LSM difference|-36.71|STANDARD_ERROR_OF_MEAN|10.34||0.0005|TWO_SIDED|95.0|-57.15|-16.27|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-16.27|-57.15|0.0005
74050310|NCT03099304|147653758|SUPERIORITY||LM difference|-35.12|STANDARD_ERROR_OF_MEAN|10.01||0.0006|TWO_SIDED|95.0|-54.91|-15.33|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-15.33|-54.91|0.0006
74050311|NCT03099304|147653758|SUPERIORITY||LSM difference|-46.02|STANDARD_ERROR_OF_MEAN|10.35|<|0.0001|TWO_SIDED|95.0|-66.47|-25.57|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-25.57|-66.47|<0.0001
74050312|NCT03099304|147653758|SUPERIORITY||LSM difference|-43.8|STANDARD_ERROR_OF_MEAN|9.98|<|0.0001|TWO_SIDED|95.0|-63.52|-24.07|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-24.07|-63.52|<0.0001
74098827|NCT05307510|147746284|SUPERIORITY|Statistical analysis is underpowered. N is too low.|Mean Difference (Net)|7.42||||0.495|TWO_SIDED|95.0|-16.16|32.0|||t-test, 2 sided|||||32.0|-16.16|.495
74098828|NCT05307510|147746285|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.953||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Buttoning Buttons||||.953
74098829|NCT05307510|147746285|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.947||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Lacing and tying a shoe||||.947
73888119|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|70.9||||0.0525|TWO_SIDED|95.0|-0.8|142.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||142.6|-0.8|0.0525
74050313|NCT03099304|147653765|SUPERIORITY||LSM difference|-2.84|STANDARD_ERROR_OF_MEAN|1.32||0.0326|TWO_SIDED|95.0|-5.44|-0.24|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.24|-5.44|0.0326
74050314|NCT03099304|147653765|SUPERIORITY||LSM difference|-2.74|STANDARD_ERROR_OF_MEAN|1.28||0.0333|TWO_SIDED|95.0|-5.26|-0.22|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.22|-5.26|0.0333
74050315|NCT03099304|147653765|SUPERIORITY||LSM difference|-5.08|STANDARD_ERROR_OF_MEAN|1.31||0.0002|TWO_SIDED|95.0|-7.68|-2.48|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-2.48|-7.68|0.0002
74050316|NCT03099304|147653765|SUPERIORITY||LSM difference|-4.08|STANDARD_ERROR_OF_MEAN|1.27||0.0016|TWO_SIDED|95.0|-6.59|-1.57|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-1.57|-6.59|0.0016
74050317|NCT03099304|147653767|SUPERIORITY||LSM difference|-23.53|STANDARD_ERROR_OF_MEAN|6.99||0.001|TWO_SIDED|95.0|-37.35|-9.71|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-9.71|-37.35|0.0010
73881338|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|7.69||||0.0129|TWO_SIDED|95.0|1.54|38.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||38.41|1.54|0.0129
73881339|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|7.12||||0.0168|TWO_SIDED|95.0|1.42|35.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||35.61|1.42|0.0168
73881340|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|9.95||||0.0058|TWO_SIDED|95.0|1.94|50.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||50.97|1.94|0.0058
73881341|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1934|TWO_SIDED|95.0|0.69|6.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.26|0.69|0.1934
73881342|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.01||||0.2181|TWO_SIDED|95.0|0.66|6.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.12|0.66|0.2181
73881343|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4116|TWO_SIDED|95.0|0.53|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.71|0.53|0.4116
74050318|NCT03099304|147653767|SUPERIORITY||LSM difference|-18.47|STANDARD_ERROR_OF_MEAN|6.77||0.0072|TWO_SIDED|95.0|-31.86|-5.08|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-5.08|-31.86|0.0072
74050319|NCT03099304|147653767|SUPERIORITY||LSM difference|-29.81|STANDARD_ERROR_OF_MEAN|6.98|<|0.0001|TWO_SIDED|95.0|-43.61|-16.0|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-16.00|-43.61|<0.0001
74050320|NCT03099304|147653767|SUPERIORITY||LSM difference|-25.56|STANDARD_ERROR_OF_MEAN|6.75||0.0002|TWO_SIDED|95.0|-38.89|-12.22|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-12.22|-38.89|0.0002
74050321|NCT03099304|147653779|SUPERIORITY||Odds Ratio (OR)|1.03||||0.4936|TWO_SIDED|95.0|0.05||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.05|0.4936
74050322|NCT03099304|147653779|SUPERIORITY||Odds Ratio (OR)|4.16||||0.114|TWO_SIDED|95.0|0.62||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.62|0.1140
74098830|NCT05307510|147746285|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.828||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Opening and closing safety pins||||.828
74098831|NCT05307510|147746285|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.169||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Managing coins||||.169
73881344|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0938|TWO_SIDED|95.0|0.84|9.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.66|0.84|0.0938
73881345|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|8.02||||0.0125|TWO_SIDED|95.0|1.57|41.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||41.08|1.57|0.0125
73881346|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|3.29||||0.0761|TWO_SIDED|95.0|0.88|12.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.23|0.88|0.0761
73881347|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0305|TWO_SIDED|95.0|1.14|14.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.16|1.14|0.0305
73881348|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|3.42||||0.0501|TWO_SIDED|95.0|1.0|11.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.68|1.00|0.0501
73881349|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1212|TWO_SIDED|95.0|0.78|8.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.77|0.78|0.1212
74050323|NCT03099304|147653779|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0501|TWO_SIDED|95.0|1.0||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||1.00|0.0501
74098832|NCT05307510|147746286|SUPERIORITY|Statistical analysis underpowered. N too small.||||||0.917||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||||||.917
74098833|NCT05307510|147746286|SUPERIORITY|Statistical analysis is underpowered. N is too small||||||0.837||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||||||.837
74098834|NCT03610516|147746294|OTHER|A repeated measures mixed model was fitted with factors for treatment group (CFZ533 or placebo) and visit.|Ratio of geometric means CFZ533/placebo|0.579||||0.0788|TWO_SIDED|95.0|0.267|1.256||one-sided p-value|Repeated measures Mixed Model|||||1.256|0.267|0.0788
74018902|NCT02167945|147590116|SUPERIORITY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|1.03||0.216|TWO_SIDED|95.0|-3.3|0.75|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.75|-3.30|0.216
74018903|NCT02167945|147590116|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.95||0.074|TWO_SIDED|95.0|-3.58|0.17|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.17|-3.58|0.074
74018904|NCT02167945|147590116|SUPERIORITY||LS Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.95||0.056|TWO_SIDED|95.0|-3.67|0.05|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.05|-3.67|0.056
74018905|NCT02167945|147590116|SUPERIORITY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|1.02||0.411|TWO_SIDED|95.0|-2.84|1.16|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.16|-2.84|0.411
74018906|NCT02167945|147590116|SUPERIORITY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.93||0.065|TWO_SIDED|95.0|-3.55|0.11|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.11|-3.55|0.065
74018907|NCT02167945|147590116|SUPERIORITY||LS Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.93||0.026|TWO_SIDED|95.0|-3.91|-0.25|||ANCOVA||F4 - F0-F1|F0-F1 vs F4 at Post-treatment Week 24||-0.25|-3.91|0.026
74018908|NCT02167945|147590117|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.95||0.035|TWO_SIDED|95.0|-3.86|-0.14|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes (PRO) score and SVR12 status as covariates."||-0.14|-3.86|0.035
74018909|NCT02167945|147590117|SUPERIORITY||LS Mean Difference|-2.15|STANDARD_ERROR_OF_MEAN|0.88||0.015|TWO_SIDED|95.0|-3.88|-0.42|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.42|-3.88|0.015
74018910|NCT02167945|147590117|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.88||0.048|TWO_SIDED|95.0|-3.46|-0.01|||ANCOVA||F4 - F0-F1|F0-F1 vs F4 at Post-treatment Week 12||-0.01|-3.46|0.048
74018911|NCT02167945|147590117|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.99||0.466|TWO_SIDED|95.0|-2.67|1.22|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.22|-2.67|0.466
74018912|NCT02167945|147590117|SUPERIORITY||LS Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.91||0.035|TWO_SIDED|95.0|-3.7|-0.13|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.13|-3.70|0.035
74018913|NCT02167945|147590117|SUPERIORITY||LS Mean Difference|-2.22|STANDARD_ERROR_OF_MEAN|0.91||0.015|TWO_SIDED|95.0|-4.01|-0.43|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.43|-4.01|0.015
74018914|NCT01058096|147590122|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.3||||0.0004|TWO_SIDED|95.0|-6.7|-1.9|||Mixed Models Analysis||cariprazine - placebo|||-1.9|-6.7|0.0004
74018915|NCT01058096|147590123|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4||||0.0027|TWO_SIDED|95.0|-0.7|-0.1|||MMRM analysis||cariprazine - placebo|||-0.1|-0.7|0.0027
74018916|NCT04276207|147590124|SUPERIORITY||Mean Difference (Final Values)|-0.377||||0.145|TWO_SIDED|95.0|-0.896|0.142|||Mixed Models Analysis|||||0.142|-0.896|0.1450
74050324|NCT03099304|147653779|SUPERIORITY||Odds Ratio (OR)|3.89||||0.1257|TWO_SIDED|95.0|0.58||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.58|0.1257
74050325|NCT01401101|147653801|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED|95.0||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); used random effects to account for correlations wi/in site \& patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.97
74050326|NCT01401101|147653802|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED|95.0|||||Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.54
74050327|NCT01401101|147653803|SUPERIORITY_OR_OTHER|||||||0.33||||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); using random effects to control for correlations w/in site \& patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.33
74050328|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.9||||0.599|TWO_SIDED|95.0|0.39|2.07||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.|||2.07|0.39|0.599
74050329|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.07||||0.442|TWO_SIDED|95.0|0.43|2.59||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.59|0.43|0.442
74050330|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.68||||0.823|TWO_SIDED|95.0|0.3|1.57||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.57|0.30|0.823
74050331|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.69|TWO_SIDED|95.0|0.33|1.97||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.97|0.33|0.690
74050332|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.75||||0.764|TWO_SIDED|95.0|0.33|1.71||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.71|0.33|0.764
74050333|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.64||||0.841|TWO_SIDED|95.0|0.27|1.56||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.56|0.27|0.841
74050334|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.702|TWO_SIDED|95.0|0.35|1.81||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7.This is the baseline corrected ratio of 100ug/placebo for day 7.|||1.81|0.35|0.702
74050335|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.91||||0.578|TWO_SIDED|95.0|0.33|2.47||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.47|0.33|0.578
74050336|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.71||||0.783|TWO_SIDED|95.0|0.29|1.7||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.70|0.29|0.783
74050337|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.64||||0.797|TWO_SIDED|95.0|0.22|1.87||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.87|0.22|0.797
74050338|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.58||||0.919|TWO_SIDED|95.0|0.27|1.26||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.26|0.27|0.919
74050339|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.55||||0.892|TWO_SIDED|95.0|0.21|1.43||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.43|0.21|0.892
74050340|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.47||||0.86|TWO_SIDED|95.0|0.11|1.93||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.|||1.93|0.11|0.860
74098835|NCT01056289|147746307|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|1.16|||||TWO_SIDED|95.0|-0.51|2.83|||ANCOVA|||Difference: Placebo versus DVS SR 50 mg||2.83|-0.51|
74098836|NCT01056289|147746307|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-1.03|2.35|||ANCOVA|||Difference: DVS SR 25 mg versus DVS SR 50 mg||2.35|-1.03|
74098837|NCT01056289|147746307|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.88|1.89|||ANCOVA|||Difference: Placebo versus DVS SR 25 mg||1.89|-0.88|
74050341|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.05||||0.463|TWO_SIDED|95.0|0.38|2.86||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.86|0.38|0.463
74050342|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.35||||0.932|TWO_SIDED|95.0|0.09|1.42||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.42|0.09|0.932
74050343|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.43||||0.952|TWO_SIDED|95.0|0.16|1.17||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.17|0.16|0.952
73881350|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8332|TWO_SIDED|95.0|0.35|3.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.68|0.35|0.8332
73881351|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.66||||0.4285|TWO_SIDED|95.0|0.48|5.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.76|0.48|0.4285
74018917|NCT04276207|147590125|SUPERIORITY||Mean Difference (Final Values)|-0.262||||0.001|TWO_SIDED|95.0|-0.406|-0.117|||Mixed Models Analysis|||||-0.117|-0.406|0.0010
74018918|NCT04276207|147590126|SUPERIORITY||Mean Difference (Final Values)|-12.61||||0.0173|TWO_SIDED|95.0|-22.73|-2.49|||Mixed Models Analysis|||Day 1||-2.49|-22.73|0.0173
73881352|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0954|TWO_SIDED|95.0|0.83|10.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.74|0.83|0.0954
74018919|NCT04276207|147590126|SUPERIORITY||Mean Difference (Final Values)|-5.75||||0.0243|TWO_SIDED|95.0|-10.69|0.81|||Mixed Models Analysis|||Day 2||0.81|-10.69|0.0243
73881353|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.98||||0.111|TWO_SIDED|95.0|0.78|11.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.38|0.78|0.1110
74018920|NCT04276207|147590127|SUPERIORITY|||||||0.945|||||||Mixed Models Analysis|||Day 1||||0.945
74018921|NCT04276207|147590127|SUPERIORITY|||||||0.888|||||||Mixed Models Analysis|||Day 2||||0.888
74018922|NCT05099640|147590138|OTHER||LS Mean Difference|-395.87|STANDARD_ERROR_OF_MEAN|33.848|<|0.0001|TWO_SIDED|95.0|-463.07|-328.66|||Mixed Models Analysis|||||-328.66|-463.07|<0.0001
74018923|NCT05099640|147590139|OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|4.973|<|0.0001|TWO_SIDED|95.0|-74.09|-54.35|||Mixed Models Analysis|||||-54.35|-74.09|<0.0001
74018924|NCT05099640|147590140|OTHER||Odds Ratio (OR)|30.33|||<|0.0001|TWO_SIDED|95.0|5.3|294.24|||Chi-squared|||||294.24|5.30|<0.0001
74018925|NCT05099640|147590141|OTHER||Odds Ratio (OR)|51.54|||<|0.0001|TWO_SIDED|95.0|12.28|245.34|||Chi-squared|||||245.34|12.28|<0.0001
74018926|NCT05099640|147590142|OTHER||LS Mean Difference|-289.89|STANDARD_ERROR_OF_MEAN|33.44|<|0.0001|TWO_SIDED|95.0|-356.29|-223.5|||Mixed Models Analysis|||Weeks 1 and 2: Sepiapterin vs. Placebo||-223.50|-356.29|<0.0001
74018927|NCT05099640|147590142|OTHER||LS Mean Difference|-375.47|STANDARD_ERROR_OF_MEAN|30.424|<|0.0001|TWO_SIDED|95.0|-435.88|-315.06|||Mixed Models Analysis|||Weeks 3 and 4: Sepiapterin vs. Placebo||-315.06|-435.88|<0.0001
74018928|NCT05099640|147590142|OTHER||LS Mean Difference|-395.87|STANDARD_ERROR_OF_MEAN|33.848|<|0.0001|TWO_SIDED|95.0|-463.07|-328.66|||Mixed Models Analysis|||Weeks 5 and 6: Sepiapterin vs. Placebo||-328.66|-463.07|<0.0001
74018929|NCT05099640|147590143|OTHER||LS Mean Difference|-42.52|STANDARD_ERROR_OF_MEAN|6.008|<|0.0001|TWO_SIDED|95.0|-54.45|-30.59|||Mixed Models Analysis|||Weeks 1 and 2: Sepiapterin vs. Placebo||-30.59|-54.45|<0.0001
74018930|NCT05099640|147590143|OTHER||LS Mean Difference|-61.03|STANDARD_ERROR_OF_MEAN|4.531|<|0.0001|TWO_SIDED|95.0|-70.02|-52.03|||Mixed Models Analysis|||Weeks 3 and 4: Sepiapterin vs. Placebo||-52.03|-70.02|<0.0001
74018931|NCT05099640|147590143|OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|4.973|<|0.0001|TWO_SIDED|95.0|-74.09|-54.35|||Mixed Models Analysis|||Weeks 5 and 6: Sepiapterin vs. Placebo||-54.35|-74.09|<0.0001
74018932|NCT05099640|147590148|OTHER||LS Mean Difference|-492.23|STANDARD_ERROR_OF_MEAN|55.588|<|0.0001|TWO_SIDED|95.0|-614.59|-369.87|||Mixed Models Analysis|||||-369.87|-614.59|<0.0001
74018933|NCT05099640|147590149|OTHER||LS Mean Difference|-74.73|STANDARD_ERROR_OF_MEAN|10.436|<|0.0001|TWO_SIDED|95.0|-97.72|-51.74|||Mixed Models Analysis|||||-51.74|-97.72|<0.0001
74018934|NCT00820755|147590167|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.959||||0.1265|TWO_SIDED|95.0|0.736|1.25|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (interactive voice response system \[IVRS\]) and tumor response status at the end of combination therapy ('complete response \[CR\] or partial response \[PR\]' versus 'other').||1.250|0.736|0.1265
74018935|NCT00820755|147590169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.774||||0.0622||95.0|0.613|0.976|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (IVRS) and tumor response status at the end of combination therapy ('CR or PR' versus 'other').||0.976|0.613|0.0622
74018936|NCT01225562|147590176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.008|TWO_SIDED|95.0|0.75|0.96|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||0.96|0.75|0.0080
74018937|NCT01225562|147590176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0043|TWO_SIDED|95.0|0.74|0.95|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||0.95|0.74|0.0043
74018938|NCT01225562|147590177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1547|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||1.06|0.71|0.1547
74018939|NCT01225562|147590177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0676|TWO_SIDED|95.0|0.68|1.01|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||1.01|0.68|0.0676
74018940|NCT01225562|147590178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9851|TWO_SIDED|95.0|0.86|1.16|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||1.16|0.86|0.9851
74018941|NCT01225562|147590178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.135|TWO_SIDED|95.0|0.76|1.04|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||1.04|0.76|0.1350
74018942|NCT01225562|147590179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.69|||<|0.0001|TWO_SIDED|95.0|1.96|3.7|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||3.70|1.96|<0.0001
74018943|NCT01225562|147590179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.68|3.21|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||3.21|1.68|<0.0001
73881354|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1642|TWO_SIDED|95.0|0.69|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.55|0.69|0.1642
74018944|NCT01162421|147590187|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3||||0.907|TWO_SIDED|95.0|-23.4|20.8|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||||20.8|-23.4|0.907
73881355|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|2.19||||0.1976|TWO_SIDED|95.0|0.66|7.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.24|0.66|0.1976
73881356|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5761|TWO_SIDED|95.0|0.43|4.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.58|0.43|0.5761
74018945|NCT01162421|147590188|SUPERIORITY_OR_OTHER||Difference in percentage|3.2||||0.762|TWO_SIDED|95.0|-17.7|24.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||24.1|-17.7|0.762
74018946|NCT01162421|147590188|SUPERIORITY_OR_OTHER||Difference in percentage|-5.3||||0.65|TWO_SIDED|95.0|-28.1|17.5|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||17.5|-28.1|0.650
74018947|NCT01162421|147590189|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.382||0.027|TWO_SIDED|95.0|-1.62|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 6||-0.10|-1.62|0.027
74018948|NCT01162421|147590189|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.46|STANDARD_ERROR_OF_MEAN|0.667||0.033|TWO_SIDED|95.0|-2.79|-0.12||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 12||-0.12|-2.79|0.033
74018949|NCT01162421|147590189|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.22|STANDARD_ERROR_OF_MEAN|1.403||0.12|TWO_SIDED|95.0|-5.05|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|||Month 24||0.60|-5.05|0.120
74018950|NCT01162421|147590190|SUPERIORITY_OR_OTHER||Difference in percentage|-11.7||||0.095|TWO_SIDED|95.0|-27.0|1.6||P-value is based on two sided Fisher's exact test.|Fisher Exact||Confidence interval is based on Wilson confidence limits.|||1.6|-27.0|0.095
74018951|NCT01162421|147590191|SUPERIORITY_OR_OTHER||Difference in percentage|12.1||||0.281|TWO_SIDED|95.0|-9.79|33.97|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||33.97|-9.79|0.281
74018952|NCT01162421|147590191|SUPERIORITY_OR_OTHER||Difference in percentage|27.0||||0.021|TWO_SIDED|95.0|4.98|48.93||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||48.93|4.98|0.021
74018953|NCT01162421|147590191|SUPERIORITY_OR_OTHER||Difference in percentage|6.7||||0.552|TWO_SIDED|95.0|-15.29|28.63|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||28.63|-15.29|0.552
74018954|NCT01162421|147590191|SUPERIORITY_OR_OTHER||Difference in percentage|-12.2||||0.281|TWO_SIDED|95.0|-34.04|9.72|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||9.72|-34.04|0.281
74018955|NCT01162421|147590191|SUPERIORITY_OR_OTHER||Difference in percentage|-14.4||||0.209|TWO_SIDED|95.0|-36.64|7.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||7.78|-36.64|0.209
74018956|NCT01162421|147590191|SUPERIORITY_OR_OTHER||Difference in percentage|-19.6||||0.091|TWO_SIDED|95.0|-41.74|2.62|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||2.62|-41.74|0.091
74018957|NCT01162421|147590192|SUPERIORITY_OR_OTHER||Difference in percentage|15.6||||0.148|TWO_SIDED|95.0|-5.05|36.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||36.26|-5.05|0.148
74018958|NCT01162421|147590192|SUPERIORITY_OR_OTHER||Difference in percentage|20.7||||0.06|TWO_SIDED|95.0|-0.14|41.61|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||41.61|-0.14|0.060
74018959|NCT01162421|147590192|SUPERIORITY_OR_OTHER||Difference in percentage|8.7||||0.451|TWO_SIDED|95.0|-13.85|31.29|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||31.29|-13.85|0.451
74018960|NCT01162421|147590192|SUPERIORITY_OR_OTHER||Difference in percentage|9.3||||0.413|TWO_SIDED|95.0|-12.82|31.43|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||31.43|-12.82|0.413
74018961|NCT01162421|147590192|SUPERIORITY_OR_OTHER||Difference in percentage|-7.3||||0.528|TWO_SIDED|95.0|-29.74|15.23|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||15.23|-29.74|0.528
74018962|NCT01162421|147590192|SUPERIORITY_OR_OTHER||Difference in percentage|-9.5||||0.399|TWO_SIDED|95.0|-31.61|12.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||12.56|-31.61|0.399
74018963|NCT01162421|147590193|SUPERIORITY_OR_OTHER||Difference in percentage|12.5||||0.111|TWO_SIDED|95.0|-1.7|27.06|||Fisher Exact|||Month 3||27.06|-1.70|0.111
74018964|NCT01162421|147590193|SUPERIORITY_OR_OTHER||Difference in percentage|19.6||||0.031|TWO_SIDED|95.0|2.74|36.53||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||36.53|2.74|0.031
74018965|NCT01162421|147590193|SUPERIORITY_OR_OTHER||Difference in percentage|2.8||||0.78|TWO_SIDED|95.0|-16.74|22.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||22.31|-16.74|0.780
74018966|NCT01162421|147590193|SUPERIORITY_OR_OTHER||Difference in percentage|16.5||||0.092|TWO_SIDED|95.0|-2.07|35.04|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||35.04|-2.07|0.092
74018967|NCT01162421|147590193|SUPERIORITY_OR_OTHER||Difference in percentage|10.8||||0.29|TWO_SIDED|95.0|-8.86|30.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||30.40|-8.86|0.290
74098838|NCT01386983|147746329|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.406||||0.0128|TWO_SIDED|95.0|1.297|8.941|||Regression, Cox|||||8.941|1.297|0.0128
73881357|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|0.64||||0.454|TWO_SIDED|95.0|0.2|2.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.04|0.20|0.4540
73881358|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|0.57||||0.3732|TWO_SIDED|95.0|0.17|1.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.96|0.17|0.3732
73881359|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4665|TWO_SIDED|95.0|0.46|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.50|0.46|0.4665
73881360|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5634|TWO_SIDED|95.0|0.41|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.25|0.41|0.5634
73881361|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.65||||0.4297|TWO_SIDED|95.0|0.48|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.70|0.48|0.4297
73888120|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|23.1||||0.5294|TWO_SIDED|95.0|-49.3|95.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||95.4|-49.3|0.5294
74018968|NCT01162421|147590193|SUPERIORITY_OR_OTHER||Difference in percentage|-16.9||||0.116|TWO_SIDED|95.0|-37.86|4.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||4.01|-37.86|0.116
74018969|NCT01162421|147590194|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.9|-1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 3||-1.2|-5.9|0.004
74018970|NCT01162421|147590194|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.8|-2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-2.3|-6.8|<0.001
74018971|NCT01162421|147590194|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.16||0.021|TWO_SIDED|95.0|-5.1|-0.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||-0.4|-5.1|0.021
74018972|NCT01162421|147590194|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.96||0.037|TWO_SIDED|95.0|-4.0|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12||-0.1|-4.0|0.037
74018973|NCT01162421|147590194|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.58||0.702|TWO_SIDED|95.0|-3.7|2.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||2.5|-3.7|0.702
74018974|NCT01162421|147590194|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.15||0.644|TWO_SIDED|95.0|-2.8|1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||1.8|-2.8|0.644
74098839|NCT01386983|147746330|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Generalized linear model|Gamma distribution with log-link function was used.||||||0.0002
74098840|NCT04746794|147746353|SUPERIORITY|||||||0.0074|||||||Chi-squared|||||||0.0074
74098841|NCT04746794|147746354|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74098842|NCT04040192|147746360|OTHER|||||||0.0034||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||||||0.0034
74098843|NCT04040192|147746362|OTHER|Analysis of covariance (ANCOVA) model included fixed effects of treatment group, age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Least square mean difference|34.59|STANDARD_ERROR_OF_MEAN|16.274||0.0346|TWO_SIDED|95.0|2.53|66.64|||ANCOVA|||||66.64|2.53|0.0346
74098844|NCT04040192|147746363|OTHER||Median Difference (Final Values)|-0.5||||0.0042|TWO_SIDED|95.0|-1.0|0.0||p-value was estimated by Wilcoxon rank sum test stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Wilcoxon (Mann-Whitney)||Median difference and 95%CI were estimated using Hodges-Lehmann method.|||0.00|-1.00|0.0042
74098845|NCT04040192|147746364|OTHER|||||||0.6815||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Baseline PP NRS \>=3 and \>=3 point reduction in PP NRS||||0.6815
74098846|NCT04040192|147746364|OTHER|||||||0.1518||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Baseline PP NRS \>=4 and \>=4 point reduction in PP NRS||||0.1518
74098847|NCT04040192|147746365|OTHER|||||||0.1933||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization|Log Rank|||||||0.1933
74098848|NCT04040192|147746366|OTHER|p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization||||||0.3778|||||||Log Rank|||Baseline ORIS Scale \>=3 and \>=3 point reduction||||0.3778
74098849|NCT04040192|147746366|OTHER|p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization||||||0.487|||||||Log Rank|||Baseline ORIS Scale \>=4 and \>=4 point reduction||||0.4870
73881362|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9789|TWO_SIDED|95.0|0.31|3.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.14|0.31|0.9789
73881363|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|0.81||||0.7357|TWO_SIDED|95.0|0.24|2.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.70|0.24|0.7357
73881364|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|0.46||||0.1977|TWO_SIDED|95.0|0.14|1.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.50|0.14|0.1977
73881365|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|0.52||||0.3203|TWO_SIDED|95.0|0.14|1.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.88|0.14|0.3203
73881366|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9739|TWO_SIDED|95.0|0.3|3.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.44|0.30|0.9739
74018975|NCT01162421|147590195|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.89||0.039|TWO_SIDED|95.0|-3.7|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||-0.1|-3.7|0.039
74050344|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.46||||0.873|TWO_SIDED|95.0|0.12|1.81||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.81|0.12|0.873
74050345|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.43||||0.953|TWO_SIDED|95.0|0.16|1.16||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.16|0.16|0.953
74050346|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|1.26||||0.281|TWO_SIDED|95.0|0.56|2.82||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||2.82|0.56|0.281
74050347|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.0||||0.5|TWO_SIDED|95.0|0.42|2.35||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||2.35|0.42|0.500
74050348|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.76||||0.744|TWO_SIDED|95.0|0.32|1.77||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||1.77|0.32|0.744
73881367|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6714|TWO_SIDED|95.0|0.36|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.97|0.36|0.6714
73881368|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6375|TWO_SIDED|95.0|0.22|2.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.52|0.22|0.6375
73881369|NCT03192176|147297631|SUPERIORITY||Odds Ratio (OR)|0.54||||0.298|TWO_SIDED|95.0|0.17|1.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.71|0.17|0.2980
73881370|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|5.35||||0.0044|TWO_SIDED|95.0|1.69|16.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.96|1.69|0.0044
73881371|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|8.65||||0.0002|TWO_SIDED|95.0|2.79|26.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||26.83|2.79|0.0002
74018976|NCT01162421|147590195|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-5.0|-1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-1.8|-5.0|<0.001
74018977|NCT01162421|147590195|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.81||0.008|TWO_SIDED|95.0|-3.8|-0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 9||-0.6|-3.8|0.008
74050349|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.21||||0.334|TWO_SIDED|95.0|0.49|3.04||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||3.04|0.49|0.334
74098850|NCT04040192|147746367|OTHER|||||||0.1159||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||||||0.1159
74098851|NCT04040192|147746368|OTHER|||||||0.6973||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||DLQI for participants \>=16 years of age||||0.6973
74098852|NCT04040192|147746368|OTHER|||||||0.7456||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Children's DLQI: participants 4-\<16 yrs of age||||0.7456
74098853|NCT04040192|147746369|OTHER|||||||0.0513||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||POEM||||0.0513
74098854|NCT04040192|147746369|OTHER|||||||0.0217||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Proxy POEM||||0.0217
74018978|NCT01162421|147590195|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.71||0.028|TWO_SIDED|95.0|-3.0|-0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12||-0.2|-3.0|0.028
74098855|NCT00875797|147746472|NON_INFERIORITY_OR_EQUIVALENCE|t-test||||||0.05|TWO_SIDED|95.0||||p\<0.05|t-test, 2 sided|||||||0.05
74098856|NCT00875797|147746473|NON_INFERIORITY_OR_EQUIVALENCE|χ2 test|percentage of infection|20.0|STANDARD_DEVIATION|10.0||0.05|TWO_SIDED|95.0||||p\<0.05|Chi-squared|2 degrees of freedom||||||0.05
74098857|NCT00875797|147746474|SUPERIORITY_OR_OTHER||percentage of survivers|80.0|||<|0.05||95.0||||p\<0.05|Chi-squared, Corrected|2-degrees of freedom||Chi-square||||<0.05
74098858|NCT00715624|147746475|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.096||0.0002|TWO_SIDED|95.0|-0.55|-0.174||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|To control type I error, a step-down procedure described by Hochberg and Tomhane was applied.||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.174|-0.550|0.0002
74098859|NCT01590797|147746509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.5|-0.19|||Robust Regression|Robust regression using M-estimation with terms for treatment and the metformin stratum and type of insulin, and baseline A1C (%) as a covariate.||||-0.19|-0.50|<0.001
74018979|NCT01162421|147590195|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.94||0.452|TWO_SIDED|95.0|-2.6|1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||1.2|-2.6|0.452
74018980|NCT01162421|147590195|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.77||0.343|TWO_SIDED|95.0|-2.3|0.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||0.8|-2.3|0.343
74018981|NCT01162421|147590196|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.26||0.22|TWO_SIDED|95.0|-7.3|1.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||1.7|-7.3|0.220
74018982|NCT01162421|147590196|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-11.0|-3.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-3.3|-11.0|<0.001
74018983|NCT01162421|147590196|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.87||0.05|TWO_SIDED|95.0|-7.5|0.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||0.0|-7.5|0.050
74018984|NCT01162421|147590196|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.95||0.725|TWO_SIDED|95.0|-4.6|3.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||3.2|-4.6|0.725
74018985|NCT01162421|147590196|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.31||0.837|TWO_SIDED|95.0|-5.1|4.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||4.1|-5.1|0.837
74018986|NCT01162421|147590196|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.83||0.661|TWO_SIDED|95.0|-4.5|2.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||2.9|-4.5|0.661
74018987|NCT01162421|147590197|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.156|TWO_SIDED|95.0|-4.4|0.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||0.7|-4.4|0.156
74018988|NCT01162421|147590197|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|-6.1|-1.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-1.9|-6.1|<0.001
74018989|NCT01162421|147590197|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.19||0.04|TWO_SIDED|95.0|-4.9|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||-0.1|-4.9|0.040
73881372|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|10.82|||<|0.0001|TWO_SIDED|95.0|3.49|33.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.54|3.49|<0.0001
74018990|NCT01162421|147590197|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.14||0.492|TWO_SIDED|95.0|-3.1|1.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||1.5|-3.1|0.492
74018991|NCT01162421|147590197|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.649|TWO_SIDED|95.0|-3.2|2.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||2.0|-3.2|0.649
73888121|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0||||0.9126|TWO_SIDED|95.0|-75.7|67.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.7|-75.7|0.9126
74018992|NCT01162421|147590197|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.11||0.464|TWO_SIDED|95.0|-3.0|1.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||1.4|-3.0|0.464
74018993|NCT01162421|147590198|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|5.08||0.018|TWO_SIDED|95.0|-22.5|-2.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||-2.2|-22.5|0.018
74018994|NCT01162421|147590198|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.5|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-37.3|-13.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-13.7|-37.3|<0.001
74018995|NCT01162421|147590198|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|5.84||0.113|TWO_SIDED|95.0|-21.0|2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9||2.3|-21.0|0.113
74018996|NCT01162421|147590198|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|5.72||0.544|TWO_SIDED|95.0|-14.9|7.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||7.9|-14.9|0.544
74018997|NCT01162421|147590198|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.96||0.916|TWO_SIDED|95.0|-12.5|11.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||11.2|-12.5|0.916
74018998|NCT01162421|147590198|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|5.86||0.983|TWO_SIDED|95.0|-11.8|11.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||11.6|-11.8|0.983
74018999|NCT01162421|147590199|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|4.96||0.641|TWO_SIDED|95.0|-12.2|7.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.6|-12.2|0.641
74019000|NCT01162421|147590199|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|5.61||0.358|TWO_SIDED|95.0|-16.4|6.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||6.0|-16.4|0.358
74019001|NCT01162421|147590199|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|5.58||0.352|TWO_SIDED|95.0|-5.9|16.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||16.4|-5.9|0.352
74019002|NCT01162421|147590199|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|5.28||0.99|TWO_SIDED|95.0|-10.5|10.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||10.6|-10.5|0.990
74019003|NCT01162421|147590199|SUPERIORITY_OR_OTHER||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|5.36||0.238|TWO_SIDED|95.0|-4.3|17.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||17.1|-4.3|0.238
74019004|NCT01162421|147590199|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.54||0.207|TWO_SIDED|95.0|-4.0|18.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||18.1|-4.0|0.207
74019005|NCT01162421|147590200|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|5.28||0.85|TWO_SIDED|95.0|-11.5|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||9.5|-11.5|0.850
74019006|NCT01162421|147590200|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|5.49||0.129|TWO_SIDED|95.0|-19.4|2.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||2.5|-19.4|0.129
74019007|NCT01162421|147590200|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|5.62||0.937|TWO_SIDED|95.0|-10.8|11.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||11.6|-10.8|0.937
74019008|NCT01162421|147590200|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.59||0.67|TWO_SIDED|95.0|-13.5|8.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||8.8|-13.5|0.670
74019009|NCT01162421|147590200|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|5.67||0.341|TWO_SIDED|95.0|-5.9|16.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||16.7|-5.9|0.341
73881373|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|10.01|||<|0.0001|TWO_SIDED|95.0|3.2|31.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||31.29|3.20|<0.0001
73881374|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.51||||0.1266|TWO_SIDED|95.0|0.77|8.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.15|0.77|0.1266
74050350|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.698|TWO_SIDED|95.0|0.35|1.85||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||1.85|0.35|0.698
74050351|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.18||||0.353|TWO_SIDED|95.0|0.48|2.88||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||2.88|0.48|0.353
74050352|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|1.01||||0.489|TWO_SIDED|95.0|0.45|2.26||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||2.26|0.45|0.489
74050353|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.46||||0.94|TWO_SIDED|95.0|0.17|1.23||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||1.23|0.17|0.940
74050354|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.01||||0.495|TWO_SIDED|95.0|0.42|2.4||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||2.40|0.42|0.495
74050355|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.82||||0.647|TWO_SIDED|95.0|0.28|2.37||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||2.37|0.28|0.647
74050356|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.87||||0.646|TWO_SIDED|95.0|0.4|1.86||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||1.86|0.40|0.646
74050357|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.74||||0.741|TWO_SIDED|95.0|0.29|1.9||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||1.90|0.29|0.741
74050358|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|2.18||||0.109|TWO_SIDED|95.0|0.62|7.95||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||7.95|0.62|0.109
74098860|NCT01590797|147746510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.002|TWO_SIDED|95.0|-0.61|-0.14|||Robust Regression|Robust regression using M-estimation with terms for treatment and type of insulin, and baseline A1C (%) as a covariate.||||-0.14|-0.61|0.002
74098861|NCT01590797|147746511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.5|||<|0.001|TWO_SIDED|95.0|-38.4|-14.7|||ANCOVA|ANCOVA model with terms for treatment and the metformin stratum and type of insulin, and baseline 2-hr Post- Meal Glucose (mg/dL) as a covariate.||||-14.7|-38.4|<0.001
74098862|NCT01559389|147746554|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_DEVIATION|2.5||0.16|TWO_SIDED|95.0|-1.23|0.21||P-values less than 0.05 were considered statistically significant.|t-test, 2 sided|The method was a paired t-test||The null hypothesis is that there is no difference in the overall GRISS score between females with UUI and their male partners||0.21|-1.23|.16
73881375|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|5.72||||0.0024|TWO_SIDED|95.0|1.85|17.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.66|1.85|0.0024
73881376|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|7.93||||0.0003|TWO_SIDED|95.0|2.59|24.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||24.26|2.59|0.0003
74050359|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.37||||0.24|TWO_SIDED|95.0|0.55|3.45||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||3.45|0.55|0.240
74050360|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.1||||0.447|TWO_SIDED|95.0|0.27|4.44||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||4.44|0.27|0.447
74050361|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.03||||0.472|TWO_SIDED|95.0|0.39|2.74||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||2.74|0.39|0.472
74050362|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.78||||0.698|TWO_SIDED|95.0|0.21|2.9||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||2.90|0.21|0.698
74050363|NCT02130635|147653824|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.53||||0.911|TWO_SIDED|95.0|0.21|1.37||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||1.37|0.21|0.911
73881377|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0217|TWO_SIDED|95.0|1.18|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.17|1.18|0.0217
73881378|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|4.63||||0.0021|TWO_SIDED|95.0|1.75|12.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.25|1.75|0.0021
73881379|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|4.72||||0.0016|TWO_SIDED|95.0|1.8|12.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.37|1.80|0.0016
73881380|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0018|TWO_SIDED|95.0|1.79|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.86|1.79|0.0018
73881381|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0467|TWO_SIDED|95.0|1.01|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.14|1.01|0.0467
74050364|NCT02608892|147653847|SUPERIORITY|Use of pain management during newborn screening was described using frequency and proportion and expressed as an absolute difference in proportions with 95% confidence interval.|Absolute difference in proportions|-7.4|||||TWO_SIDED|95.0|-26.2|11.5||||||||11.5|-26.2|
74050365|NCT02590406|147653851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANOVA|||We calculated our sample size using data from EPO2: PV study (Couture: simultaneous submitted manuscript), where we found a difference in the FRC of 21% between reverse Trendelenburg with non-invasive positive pressure ventilation and beach chair position without positive pressure ventilation. Assuming there would be a difference of 21% in the apnea time, with a type I error of 5% and power of 80%, a total of 17 patients by group was needed.||||0.005
74050366|NCT02590406|147653852|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
74098863|NCT01559389|147746555|SUPERIORITY||z-score|2.97||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Exact test|The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between responders and non-responders of solifenacin treatment|The null hypothesis is that there is no difference in the overall GRISS change score between those who respond and do not respond to treatment with solifenacin.||||.003
74098864|NCT01559389|147746556|SUPERIORITY||z-score|0.89||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between the two groups|The null hypothesis is that there is no difference in the overall GRISS change score between male partners of female participants who respond to solifenacin and male partners of female participants who do not respond to solifenacin||||.37
74098865|NCT03201445|147746557|OTHER||Difference in Percentage|-7.8|||||TWO_SIDED|95.0|-16.3|0.7|||||Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test.|||0.7|-16.3|
73881382|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|4.7||||0.0016|TWO_SIDED|95.0|1.8|12.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.28|1.80|0.0016
73881383|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0234|TWO_SIDED|95.0|1.16|7.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.65|1.16|0.0234
73881384|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0294|TWO_SIDED|95.0|1.11|7.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.46|1.11|0.0294
73881385|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.74||||0.0068|TWO_SIDED|95.0|1.44|9.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.73|1.44|0.0068
73881386|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|4.35||||0.0025|TWO_SIDED|95.0|1.68|11.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.29|1.68|0.0025
74050367|NCT02590406|147653853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||ANOVA|||||||0.0003
74050368|NCT02590406|147653854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||ANOVA|||||||0.9
74050369|NCT02590406|147653855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||ANOVA|||||||0.03
74050370|NCT00957723|147653858|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change from pre-op to 1 year, 2 year and 5 year||||<0.0001
74050371|NCT00957723|147653859|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change from pre-op to 1, 2, and 5 year||||<0.0001
74050372|NCT00957723|147653861|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||SF36 Physical Component Score change from preop to 1 year||||<0.0001
74050373|NCT00957723|147653861|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Sign test|||SF36 Mental Component Score change from preop to 1 year||||0.0002
74050374|NCT00957723|147653861|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 2 years||||<0.0001
74019010|NCT01162421|147590200|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|6.13||0.621|TWO_SIDED|95.0|-9.2|15.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||15.3|-9.2|0.621
74019011|NCT01162421|147590201|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.29||0.697|TWO_SIDED|95.0|-5.3|7.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.9|-5.3|0.697
74050375|NCT00957723|147653861|SUPERIORITY_OR_OTHER|||||||0.0177|||||||Sign test|||SF36 Mental Component Score change from preop to 2 years||||0.0177
74019012|NCT01162421|147590201|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|4.51||0.744|TWO_SIDED|95.0|-10.5|7.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||7.5|-10.5|0.744
74019013|NCT01162421|147590201|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|3.95||0.967|TWO_SIDED|95.0|-7.7|8.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||8.0|-7.7|0.967
74019014|NCT01162421|147590201|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.3||0.377|TWO_SIDED|95.0|-3.7|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||9.5|-3.7|0.377
74019015|NCT01162421|147590201|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.5||0.122|TWO_SIDED|95.0|-1.5|12.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||12.4|-1.5|0.122
74019016|NCT01162421|147590201|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|3.42||0.49|TWO_SIDED|95.0|-4.4|9.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||9.2|-4.4|0.490
74019017|NCT01162421|147590202|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.102|TWO_SIDED|95.0|-1.0|0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||0.1|-1.0|0.102
74019018|NCT01162421|147590202|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.29||0.003|TWO_SIDED|95.0|-1.5|-0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6||-0.3|-1.5|0.003
74019019|NCT01162421|147590202|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.214|TWO_SIDED|95.0|-0.9|0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9||0.2|-0.9|0.214
74019020|NCT01162421|147590202|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.339|TWO_SIDED|95.0|-0.8|0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||0.3|-0.8|0.339
74019021|NCT01162421|147590202|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.973|TWO_SIDED|95.0|-0.6|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||0.6|-0.6|0.973
74019022|NCT01162421|147590202|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.755|TWO_SIDED|95.0|-0.6|0.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||0.5|-0.6|0.755
74019023|NCT01162421|147590203|SUPERIORITY_OR_OTHER||Difference in percentage|9.4||||0.316|TWO_SIDED|95.0|-7.09|25.13|||Fisher Exact|Two-sided Fisher Exact test.||Month 3||25.13|-7.09|0.316
74019024|NCT01162421|147590203|SUPERIORITY_OR_OTHER||Difference in percentage|24.5||||0.014|TWO_SIDED|95.0|6.09|42.85|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6||42.85|6.09|0.014
74019025|NCT01162421|147590203|SUPERIORITY_OR_OTHER||Difference in percentage|-3.2||||0.762|TWO_SIDED|95.0|-24.1|17.66|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||17.66|-24.10|0.762
74019026|NCT01162421|147590203|SUPERIORITY_OR_OTHER||Difference in percentage|13.0||||0.22|TWO_SIDED|95.0|-7.46|33.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||33.54|-7.46|0.220
74019027|NCT01162421|147590203|SUPERIORITY_OR_OTHER||Difference in percentage|-3.5||||0.747|TWO_SIDED|95.0|-24.9|17.86|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||17.86|-24.90|0.747
74019028|NCT01162421|147590203|SUPERIORITY_OR_OTHER||Difference in percentage|-4.4||||0.701|TWO_SIDED|95.0|-26.8|18.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||18.01|-26.80|0.701
74019029|NCT01162421|147590204|SUPERIORITY_OR_OTHER||Difference in percentage|10.5||||0.318|TWO_SIDED|95.0|-9.83|30.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||30.78|-9.83|0.318
74019030|NCT01162421|147590204|SUPERIORITY_OR_OTHER||Difference in percentage|22.7||||0.047|TWO_SIDED|95.0|1.03|44.39|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6||44.39|1.03|0.047
74019031|NCT01162421|147590204|SUPERIORITY_OR_OTHER||Difference in percentage|5.0||||0.668|TWO_SIDED|95.0|-17.74|27.71|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||27.71|-17.74|0.668
74050376|NCT00957723|147653861|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 3 year||||<0.0001
74050377|NCT00957723|147653861|SUPERIORITY_OR_OTHER|||||||0.0393|||||||Sign test|||SF36 Mental Component Score change from preop to 3 year||||0.0393
74050378|NCT00957723|147653861|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 4 year||||<0.0001
74050379|NCT00957723|147653861|SUPERIORITY_OR_OTHER|||||||0.4905|||||||t-test, 2 sided|||SF36 Mental Component Score change from preop to 4 year||||0.4905
74050380|NCT00957723|147653861|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 5 year||||<0.0001
74050381|NCT00957723|147653861|SUPERIORITY_OR_OTHER|||||||0.0037|||||||Sign test|||SF36 Mental Component Score change from preop to 5 year||||0.0037
74050382|NCT00957723|147653863|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||LEAS score change from preop to 1, 2, 3, 4, and 5 years||||<0.0001
74050383|NCT03860181|147653908|EQUIVALENCE|The statistical significance's p-value was set at 0.05. For Surgeon 1's differences, they were calculated as patient POSAS score - surgeon POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.||||||0.896|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney U = 215||||||0.896
74050384|NCT03860181|147653908|EQUIVALENCE|The statistical significance's p-value was set at 0.05. For Surgeon 2's differences, they were calculated as patient POSAS score - surgeon POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.||||||0.612|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney U = 210||||||0.612
74050385|NCT05281094|147653945|SUPERIORITY||Vaccine Efficacy|12.98|||||TWO_SIDED|95.0|-52.51|50.35|||||. Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||50.35|-52.51|
74050386|NCT05281094|147653946|SUPERIORITY||Vaccine Efficacy|17.02|||||TWO_SIDED|95.0|-24.52|44.7|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1||44.70|-24.52|
74050387|NCT05281094|147653947|SUPERIORITY||Vaccine Efficacy|13.91|||||TWO_SIDED|95.0|-34.7|44.98|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||44.98|-34.70|
74050388|NCT05281094|147653948|SUPERIORITY||Vaccine Efficacy|-6.37|||||TWO_SIDED|95.0|-45.04|22.0|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||22.00|-45.04|
74050389|NCT00631969|147653965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.109|||<|0.0001||95.0|-8.562|-5.6561|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.||-5.6561|-8.562|< 0.0001
74050390|NCT00631969|147653966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.027|||<|0.0001||95.0|-35.519|-22.534|||ANCOVA|||Statistical analysis applies to the total population.||-22.534|-35.519|< 0.0001
74050391|NCT00631969|147653967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.193|||<|0.0001||95.0|-45.021|-31.366|||ANCOVA|||Statistical analysis applies to the total population.||-31.366|-45.021|< 0.0001
74050392|NCT00631969|147653968|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|34.778|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for age group and pooled center.||Statistical analysis applies to the total population.||||<0.0001
74050393|NCT00631969|147653969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.503|||<|0.0001||95.0|-22.424|-10.764|||ANCOVA|||Statistical analysis applies to the total population.||-10.764|-22.424|< 0.0001
74050394|NCT00631969|147653970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.167|||<|0.0001||95.0|-45.261|-31.073|||ANCOVA|||Statistical analysis applies to the total population.||-31.073|-45.261|< 0.0001
74050395|NCT00631969|147653971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.555|||<|0.0001||95.0|-43.645|-29.465|||ANCOVA|||Statistical analysis applies to the total population.||-29.465|-43.645|< 0.0001
74050396|NCT00631969|147653972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.193|||<|0.0001||95.0|-31.562|-18.824|||ANCOVA|||Statistical analysis applies to the total population.||-18.824|-31.562|< 0.0001
74050397|NCT00631969|147653974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.703|||<|0.0001||95.0|-30.067|-19.34|||ANCOVA|||Statistical analysis applies to the total population.||-19.340|-30.067|< 0.0001
74050398|NCT00631969|147653975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.496|||<|0.0001||95.0|-34.865|-24.128|||ANCOVA|||Statistical analysis applies to the total population.||-24.128|-34.865|< 0.0001
74050399|NCT00631969|147653976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.775|||<|0.0001||95.0|-33.155|-22.394|||ANCOVA|||Statistical analysis applies to the total population.||-22.394|-33.155|< 0.0001
74098866|NCT03201445|147746559|OTHER||Median Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.1|1.8|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||1.8|-2.1|
74050400|NCT00631969|147653977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.326|||<|0.0001||95.0|-29.062|-17.598|||ANCOVA|||Statistical analysis applies to the total population.||-17.598|-29.062|< 0.0001
74050401|NCT00631969|147653978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.384|||<|0.0001||95.0|-28.594|-18.175|||ANCOVA|||Statistical analysis applies to the total population.||-18.175|-28.594|< 0.0001
74050402|NCT00631969|147653979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.076|||<|0.0001||95.0|-38.745|-27.407|||ANCOVA|||Statistical analysis applies to the total population.||-27.407|-38.745|< 0.0001
74050403|NCT00631969|147653980|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|74.449|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for pooled centers and age group.||Statistical analysis applies to the total population.||||<0.0001
74050404|NCT00631969|147653981|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|117.42||||||90.0|79.59|173.23||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||173.23|79.59|
74050405|NCT00631969|147653981|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7064||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.||||0.7064
74050406|NCT00631969|147653982|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|133.07||||||90.0|87.46|202.46||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||202.46|87.46|
74050407|NCT00631969|147653982|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.8749||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.||||0.8749
74050408|NCT00631969|147653983|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|125.28||||||90.0|73.65|213.11||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years/ patients aged \< 65 years) were calculated.||213.11|73.65|
74050409|NCT00631969|147653983|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7375||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.||||0.7375
74050410|NCT00631969|147653984|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|123.84||||||90.0|80.12|191.42||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||191.42|80.12|
74098867|NCT03201445|147746561|OTHER||Median Difference (Final Values)|5.7|||||TWO_SIDED|95.0|-13.4|24.7|||||Difference in medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||24.7|-13.4|
74050411|NCT00631969|147653984|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.394||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.||||0.3940
74050412|NCT05315297|147653985|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
74050413|NCT05315297|147653986|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
74050414|NCT05315297|147653987|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
74050415|NCT05315297|147653988|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
74098868|NCT03201445|147746563|OTHER||Median Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||4.9|-2.8|
74098869|NCT03201445|147746565|OTHER||Median Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.1|0.3|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||0.3|-0.1|
74098870|NCT03201445|147746567|OTHER||Median Difference (Final Values)|2.0|||||TWO_SIDED|95.0|0.0|4.0|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||4|0|
74050416|NCT05315297|147653989|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
74050417|NCT05315297|147653990|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
74050418|NCT02043704|147654031|EQUIVALENCE|The null hypothesis is that there is no difference in the pain scores between the groups.||||||0.328||||||The p-value was not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|There were no adjustments.||The comparison was analyzed using the Mann-Whitney U test.||||0.328
74050419|NCT01432236|147654076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.0001|TWO_SIDED|95.0|-0.91|-0.31||Primary analysis was two-sided and performed at the 0.05 significance level.|Mixed Models Analysis|Satterthwaite's approximation was used to estimate denominator degrees of freedom.||Analysis was done using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.31|-0.91|0.0001
74050420|NCT01432236|147654078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6|||<|0.0001|TWO_SIDED|95.0|-9.33|-3.87||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the FIQ total score. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-3.87|-9.33|<0.0001
74050421|NCT01432236|147654078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42||||0.0078|TWO_SIDED|95.0|-0.74|-0.11||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for parameter 'physical impairment'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.11|-0.74|0.0078
74050422|NCT01432236|147654078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.0014|TWO_SIDED|95.0|-1.36|-0.33||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'feel good'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.33|-1.36|0.0014
74050423|NCT01432236|147654078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.005|TWO_SIDED|95.0|-1.01|-0.18||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above for parameter 'work missed'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.18|-1.01|0.0050
74050424|NCT01432236|147654078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.0002|TWO_SIDED|95.0|-1.14|-0.36||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'do work'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.36|-1.14|0.0002
74050425|NCT01432236|147654078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0006|TWO_SIDED|95.0|-1.0|-0.28||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'pain'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.28|-1.00|0.0006
74050426|NCT01432236|147654078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.0315|TWO_SIDED|95.0|-0.85|-0.04||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'fatigue'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.04|-0.85|0.0315
74050427|NCT01432236|147654078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76||||0.0003|TWO_SIDED|95.0|-1.17|-0.35||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'rested'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.35|-1.17|0.0003
74050428|NCT01432236|147654078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.0007|TWO_SIDED|95.0|-1.11|-0.31||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'stiffness'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.31|-1.11|0.0007
74050429|NCT01432236|147654078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55||||0.0048|TWO_SIDED|95.0|-0.93|-0.17||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'anxiety'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.17|-0.93|0.0048
74050430|NCT01432236|147654078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.53||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'depression'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.53|-1.32|<0.0001
74050431|NCT01432236|147654079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED|||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using Cochran Mantel-Haenszel (CMH) test with modified ridit transformation.||||0.0637
74050432|NCT01432236|147654080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|TWO_SIDED|||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using CMH test with modified ridit transformation.||||0.1160
74050433|NCT01432236|147654081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 30% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.||||0.0007
74050434|NCT01432236|147654081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0205|TWO_SIDED|||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 50% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.||||0.0205
74050435|NCT01432236|147654082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|||<|0.0001|TWO_SIDED|95.0|0.31|0.84||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-subject error as random factors.||0.84|0.31|<0.0001
74050436|NCT01432236|147654083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.81||||0.0018|TWO_SIDED|95.0|-12.66|-2.96||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-2.96|-12.66|0.0018
74050437|NCT01432236|147654084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8||||0.0117|TWO_SIDED|95.0|-10.29|-1.31||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors||-1.31|-10.29|0.0117
74050438|NCT01432236|147654085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.35||||0.0511|TWO_SIDED|95.0|-0.04|16.74||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||16.74|-0.04|0.0511
74050439|NCT01432236|147654086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13||||0.1139|TWO_SIDED|95.0|-0.29|0.03||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors. Analyzed as a count variable using a generalized linear model assuming a Poisson distribution and utilizing a log link transformation.||0.03|-0.29|0.1139
74050440|NCT01432236|147654088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.5||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-A (anxiety). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.50|-1.40|<0.0001
74050441|NCT01432236|147654088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.88||||0.0005|TWO_SIDED|95.0|-1.37|-0.39||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-D (depression). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and subject within sequence and within-subject error as random factors.||-0.39|-1.37|0.0005
74050442|NCT01432236|147654090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.3854|TWO_SIDED|95.0|-0.02|0.06||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||0.06|-0.02|0.3854
74050443|NCT01432236|147654092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55||||0.0085|TWO_SIDED|95.0|0.14|0.97||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||0.97|0.14|0.0085
74050444|NCT04607291|147654120|OTHER|A logistic regression model was used to identify factors associated with screening.|||||||||||||||||"A logistic regression model was used to identify factors associated with screening. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC.~Factors included in the model: sex, stool test recommended by physician, know where to get stool test, fear of colonoscopy index score, ABR - afraid score, and knowledge that colonoscopy can reduce worry.~AUC: 0.71"|||
74050445|NCT04607291|147654121|OTHER|A logistic regression model was used to identify characteristics associated with high intent of getting a Fit test.||||||||||||||||Evaluating factors associated with high intent of getting a Fit test.|"A logistic regression model was used to identify factors associated with high intent of getting a fit test. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC.~Factors included in the model: sex, race, stool test or colonoscopy recommended by physician, know where to get stool test, CBPR score, and barriers to screening score.~AUC: 0.80"|||
74050446|NCT01749930|147654130|NON_INFERIORITY|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs \<1.5 mmHg at all time points of each visit and \<1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI\<0 mmHg at all time points of each visit.||||||0.216||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol. Superiority of BOL-303259-X to timolol was demonstrated at 8 of 9 time points (exception at 8 am Week 2).|ANCOVA|||||||0.216
73881387|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|5.82||||0.0006|TWO_SIDED|95.0|2.13|15.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.92|2.13|0.0006
73881388|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0572|TWO_SIDED|95.0|0.97|6.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.61|0.97|0.0572
73881389|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0003|TWO_SIDED|95.0|2.28|15.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.97|2.28|0.0003
74050447|NCT01749930|147654131|OTHER|||||||0.084|||||||Chi-squared|||||||0.084
74050448|NCT01749930|147654132|OTHER|||||||0.007|||||||Chi-squared|||||||0.007
74098871|NCT01346293|147746595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% Confidence intervals (CIs) of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Pertussis toxoid antigen between groups were \> -10%.|Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|0.7|10.2||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||10.2|0.7|
74098872|NCT01346293|147746595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Filamentous Haemagglutinin between groups were \> -10%.|Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|2.5|21.5||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||21.5|2.5|
74050449|NCT01749930|147654133|OTHER||||||||||||||||||No statistical analysis was performed on these proportions|||
74050450|NCT04735432|147654134|NON_INFERIORITY|This was a phase 3, multicenter, randomized, open-label, parallel-group, 12-week study to evaluate the noninferiority of the pharmacodynamic effect of efgartigimod PH20 SC 1000 mg compared with efgartigimod IV 10 mg/kg in patients with generalized myasthenia gravis.|LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.782|<|0.0001|TWO_SIDED|95.0|-7.73|-0.66|||ANCOVA|||The primary endpoint was analyzed using an ANCOVA model with treatment as a factor and total IgG levels at baseline as a covariate. The NI evaluation was based on a percent reduction from baseline in total IgG levels at day 29 (week 4) using an NI margin of 10%. Only the results for mITT analysis set are entered.||-0.66|-7.73|< 0.0001
74050451|NCT00626327|147654148|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV-MMRV)|-1.0|||||TWO_SIDED|95.0|-3.4|0.5||||||Non-inferiority of immune response to measles following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV given alone.||0.5|-3.4|
74050452|NCT00626327|147654148|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for mumps was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV - MMRV )|1.0|||||TWO_SIDED|95.0|-1.0|3.7||||||Non-inferiority of immune response to mumps following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||3.7|-1|
74050453|NCT00626327|147654148|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for rubella was greater than -5%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-2.0|||||TWO_SIDED|95.0|-4.5|0.8||||||Non-inferiority of immune response to rubella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||0.8|-4.5|
74098873|NCT01346293|147746595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for the Pertactin antigens between groups were \> -10%.|Mean Difference (Final Values)|3.7|||||TWO_SIDED|3.7|-0.2|7.9||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||7.9|-0.2|
73881390|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.55||||0.046|TWO_SIDED|95.0|1.02|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.38|1.02|0.0460
73881391|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1406|TWO_SIDED|95.0|0.79|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.23|0.79|0.1406
73881392|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.97||||0.0234|TWO_SIDED|95.0|1.16|7.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.63|1.16|0.0234
74098874|NCT01346293|147746595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Fimbriae types 2 and 3 antigens between groups were \> -10%.|Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|0.9|9.1||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||9.1|0.9|
74098875|NCT01346293|147746596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertussis Toxoid antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.68|2.31||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each Pertussis antigen and their 2-sided 95% Confidence Intervals.||2.31|1.68|
74098876|NCT01346293|147746596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Filamentous Haemagglutinin antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.56|||||TWO_SIDED|95.0|1.3|1.88||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.88|1.30|
74098877|NCT01346293|147746596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertactin antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.51|||||TWO_SIDED|95.0|1.27|1.79||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.79|1.27|
74098878|NCT01346293|147746596|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL® ) in post-vaccination GMCs for the Fimbriae types 2 and 3 antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.33|||||TWO_SIDED|95.0|1.12|1.6||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.60|1.12|
74098879|NCT02687217|147746606|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
74098880|NCT02687217|147746607|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.5
74098881|NCT02687217|147746608|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.5
74098882|NCT03898908|147746621|SUPERIORITY|||||||0.015||||||pValues below 0.05 are considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison between baseline and Week 8||||0.015
74019032|NCT01162421|147590204|SUPERIORITY_OR_OTHER||Difference in percentage|7.8||||0.5|TWO_SIDED|95.0|-14.88|30.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||30.56|-14.88|0.500
74098883|NCT03898908|147746622|SUPERIORITY|||||||0.754||||||pValues below 0.05 are considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison between baseline and W24||||0.754
74098884|NCT04693416|147746648|OTHER|||||||0.252|||||||t-test, 2 sided|||Pre/post scores within arm||||0.252
74098885|NCT04693416|147746649|OTHER|||||||0.546|||||||t-test, 2 sided|||Pre/post score within arm||||0.546
74098886|NCT04693416|147746650|OTHER|||||||0.005|||||||t-test, 2 sided|||Pre/post scores within arm||||0.005
74098887|NCT04693416|147746651|OTHER|||||||0.188|||||||t-test, 2 sided|||Pre/post scores within arm||||0.188
74098888|NCT04693416|147746652|OTHER|||||||0.049|||||||t-test, 2 sided|||Pre/post score within arm||||0.049
74098889|NCT04693416|147746653|OTHER|||||||0.036|||||||t-test, 2 sided|||Pre/post scores within arm||||0.036
74098890|NCT00474266|147746655|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|2.2|||||TWO_SIDED|95.0|0.29|6.78||||||||6.78|0.29|
74098891|NCT00474266|147746655|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%|Difference in percentage|0.28|||||TWO_SIDED|95.0|-0.78|1.58||||||||1.58|-0.78|
74098892|NCT00474266|147746655|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.28|||||TWO_SIDED|95.0|-0.79|1.58||||||||1.58|-0.79|
74098893|NCT00474266|147746655|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|1.07||||||||1.07|-1.06|
74098894|NCT00474266|147746656|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|3.17||||||||3.17|-1.06|
74098895|NCT00474266|147746657|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|4.06|||||TWO_SIDED|95.0|-2.82|12.46||||||||12.46|-2.82|
74019033|NCT01162421|147590204|SUPERIORITY_OR_OTHER||Difference in percentage|-2.7||||0.816|TWO_SIDED|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||20.10|-25.52|0.816
74019034|NCT01162421|147590204|SUPERIORITY_OR_OTHER||Difference in percentage|-10.7||||0.358|TWO_SIDED|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.99|-33.38|0.358
74019035|NCT01162421|147590205|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.444|TWO_SIDED|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||28.00|-12.17|0.444
74019036|NCT01162421|147590205|SUPERIORITY_OR_OTHER||Difference in percentage|20.1||||0.076|TWO_SIDED|95.0|-1.53|41.83|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||41.83|-1.53|0.076
74019037|NCT01162421|147590205|SUPERIORITY_OR_OTHER||Difference in percentage|2.7||||0.816|TWO_SIDED|95.0|-20.1|25.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||25.52|-20.10|0.816
74050454|NCT00626327|147654148|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroprotection for varicella was greater than -10%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-1.0|||||TWO_SIDED|95.0|-3.9|1.2||||||Non-inferiority of immune response to varicella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||1.2|-3.9|
74019038|NCT01162421|147590205|SUPERIORITY_OR_OTHER||Difference in percentage|8.1||||0.485|TWO_SIDED|95.0|-14.61|30.87|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||30.87|-14.61|0.485
74019039|NCT01162421|147590205|SUPERIORITY_OR_OTHER||Difference in percentage|-2.7||||0.816|TWO_SIDED|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||20.10|-25.52|0.816
74019040|NCT01162421|147590205|SUPERIORITY_OR_OTHER||Difference in percentage|-10.7||||0.358|TWO_SIDED|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.99|-33.38|0.358
74050455|NCT00626327|147654149|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||TWO_SIDED|95.0|-4.7|4.5||||||Non-inferiority of immune response of MenACWY-CRM against serogroup A when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||4.5|-4.7|
74050456|NCT00626327|147654149|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||TWO_SIDED|95.0|-1.8|1.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup C when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||1.9|-1.8|
74050457|NCT00626327|147654149|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|1.0|||||TWO_SIDED|95.0|-1.3|3.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup W-135 when concomitantly administered with MMRV vaccine as compared to MenACWY vaccine given alone.||3.9|-1.3|
74050458|NCT00626327|147654149|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|2.0|||||TWO_SIDED|95.0|-1.9|5.3||||||Non-inferiority of immune response of MenACWY-CRM against serogroup Y when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||5.3|-1.9|
74050459|NCT00626327|147654154|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MMRV+MenACWY group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentages of subjects with seroconversion for varicella was greater than -10%.|Difference% (MenACWY-CRM+MMRV- MMRV)|-1.0|||||TWO_SIDED|95.0|-2.4|0.8||||||Non-inferiority of anti-varicella response following one dose of MMRV when administered concomitantly with MenACWY vaccine as compared to MMRV administered alone.||0.8|-2.4|
74098896|NCT00474266|147746658|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|3.18||||||||3.18|-1.06|
74019041|NCT01162421|147590206|SUPERIORITY_OR_OTHER||Difference in percentage|11.6||||0.316|TWO_SIDED|95.0|-10.84|33.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||33.99|-10.84|0.316
74019042|NCT01162421|147590206|SUPERIORITY_OR_OTHER||Difference in percentage|5.1||||0.63|TWO_SIDED|95.0|-15.43|25.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||25.54|-15.43|0.630
74019043|NCT01162421|147590206|SUPERIORITY_OR_OTHER||Difference in percentage|-0.4||||0.972|TWO_SIDED|95.0|-20.94|20.21|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||20.21|-20.94|0.972
74019044|NCT01162421|147590206|SUPERIORITY_OR_OTHER||Difference in percentage|-14.1||||0.186|TWO_SIDED|95.0|-34.83|6.7|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||6.70|-34.83|0.186
74019045|NCT01162421|147590206|SUPERIORITY_OR_OTHER||Difference in percentage|-12.6||||0.142|TWO_SIDED|95.0|-29.46|4.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||4.26|-29.46|0.142
74019046|NCT01162421|147590206|SUPERIORITY_OR_OTHER||Difference in percentage|-4.0||||0.727|TWO_SIDED|95.0|-20.34|11.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.52|-20.34|0.727
74019047|NCT01162421|147590207|SUPERIORITY_OR_OTHER||Difference in percentage|6.8||||0.486|TWO_SIDED|95.0|-9.21|22.22|||Fisher Exact|Two-sided Fisher Exact test.||||22.22|-9.21|0.486
74019048|NCT01162421|147590208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.13||0.809|TWO_SIDED|95.0|-0.23|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||0.29|-0.23|0.809
73881393|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0302|TWO_SIDED|95.0|1.1|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.22|1.10|0.0302
73881394|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|5.23||||0.0016|TWO_SIDED|95.0|1.87|14.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.63|1.87|0.0016
74098897|NCT00474266|147746659|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|3.36|||||TWO_SIDED|95.0|-0.28|9.5||||||||9.5|-0.28|
74098898|NCT03344861|147746688|OTHER|No comparator arm.|Clopper-Pearson (binomial proportion)|0.05|||<|0.05|TWO_SIDED||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion.|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion|Adverse events will be listed, coded by MedDRA, by system organ class and preferred term.||||<0.05
74098899|NCT03344861|147746713|OTHER||||||<|0.05|||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage, calculated using exact (Clopper-Pearson) method for binomial proportion.||"All adverse event terms are coded using MedDRA Dictionary version 21.1. NCS (Non-Clinical Significant) events were not included in the summary because their CTCAE grade and relationship were not collected. Subjects are counted once within each system organ class and each preferred term. An AE is defined as treatment related if its relationship to the study drug is recorded as reasonable possibility on the CRF (Case Report Form)."||||<0.05
74098900|NCT03095638|147746714|OTHER||Ratio|1.0084|||||TWO_SIDED|90.0|0.8626|1.1789||||||||1.1789|0.8626|
74098901|NCT03095638|147746715|OTHER||Ratio|1.0121|||||TWO_SIDED|90.0|0.8648|1.1845||||||||1.1845|0.8648|
74098902|NCT03095638|147746716|OTHER||Ration|1.0329|||||TWO_SIDED|90.0|0.8623|1.2373||||||||1.2373|0.8623|
74050460|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.596||||0.0045|TWO_SIDED|95.0|1.704|18.378|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \[Wk\] 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||18.378|1.704|0.0045
74050461|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.989||||0.9755|TWO_SIDED|95.0|0.497|1.967|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.967|0.497|0.9755
74098903|NCT03095638|147746717|OTHER||Ratio|1.6242|||||TWO_SIDED|90.0|1.4986|1.7604||||||||1.7604|1.4986|
74098904|NCT03095638|147746717|OTHER||Ratio|1.5448|||||TWO_SIDED|90.0|1.4253|1.6743||||||||1.6743|1.4253|
74098905|NCT03095638|147746718|OTHER||Ratio|1.6292|||||TWO_SIDED|90.0|1.503|1.7661||||||||1.7661|1.5030|
74098906|NCT03095638|147746718|OTHER||Ratio|1.5519|||||TWO_SIDED|90.0|1.4317|1.6822||||||||1.6822|1.4317|
74098907|NCT03095638|147746719|OTHER||Ratio|1.7933|||||TWO_SIDED|90.0|1.6226|1.9819||||||||1.9819|1.6226|
74098908|NCT03095638|147746719|OTHER||Ratio|1.7974|||||TWO_SIDED|90.0|1.6263|1.9865||||||||1.9865|1.6263|
73881395|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2105|TWO_SIDED|95.0|0.71|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.64|0.71|0.2105
73881396|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|4.17||||0.0033|TWO_SIDED|95.0|1.61|10.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.81|1.61|0.0033
74098909|NCT06281171|147746791|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
74098910|NCT06281171|147746792|SUPERIORITY|||||||0.996|||||||t-test, 2 sided|||||||.996
74098911|NCT06281171|147746793|SUPERIORITY|||||||0.782|||||||t-test, 2 sided|||||||.782
74098912|NCT06281171|147746794|SUPERIORITY|||||||0.54|||||||Regression, Linear|||||||0.54
74098913|NCT06281171|147746795|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
74098914|NCT06281171|147746796|SUPERIORITY|||||||0.3|||||||Regression, Linear|||||||0.30
74098915|NCT06281171|147746797|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
74098916|NCT02552212|147746798|OTHER||Odds Ratio (OR)|15.231|||<|0.001|TWO_SIDED|95.0|7.336|31.623|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and Magnetic Resonance Imaging/C- Reactive Protein (MRI/CRP) classification.||31.623|7.336|<0.001
74098917|NCT02552212|147746799|OTHER||Odds Ratio (OR)|7.436|||<|0.001|TWO_SIDED|95.0|4.127|13.401|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||13.401|4.127|<0.001
74098918|NCT02552212|147746809|OTHER||Odds Ratio (OR)|7.359|||<|0.001|TWO_SIDED|95.0|4.286|12.636|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region MRI/CRP classification.||12.636|4.286|<0.001
74098919|NCT02552212|147746810|OTHER||Difference|-1.696|||<|0.001|TWO_SIDED|95.0|-2.11|-1.282|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.282|-2.110|<0.001
74098920|NCT02552212|147746811|OTHER||Difference|-1.585|||<|0.0001|TWO_SIDED|95.0|-2.132|-1.038|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.038|-2.132|<0.0001
74098921|NCT02552212|147746812|OTHER||Difference|-1.819|||<|0.001|TWO_SIDED|95.0|-2.25|-1.388|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.388|-2.250|<0.001
73881397|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1087|TWO_SIDED|95.0|0.85|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.21|0.85|0.1087
74050462|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.743||||0.4786|TWO_SIDED|95.0|0.327|1.688|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.688|0.327|0.4786
74050463|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.38||||0.014|TWO_SIDED|95.0|1.405|20.597|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||20.597|1.405|0.0140
74050464|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078|||<|0.0001|TWO_SIDED|95.0|1.062|1.094|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.094|1.062|<0.0001
74050465|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.136||||0.0035|TWO_SIDED|95.0|1.819|20.701|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||20.701|1.819|0.0035
74050466|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.7821|TWO_SIDED|95.0|0.439|1.857|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.857|0.439|0.7821
74050467|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.4846|TWO_SIDED|95.0|0.317|1.723|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.723|0.317|0.4846
74050468|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.424||||0.017|TWO_SIDED|95.0|1.353|21.749|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||21.749|1.353|0.0170
74098922|NCT02552212|147746813|OTHER||Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.909|-0.672|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-0.672|-1.909|<0.001
74098923|NCT02552212|147746814|OTHER||Difference|-4.8687|||<|0.001|TWO_SIDED|95.0|-6.4014|-3.336|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-3.3360|-6.4014|<0.001
74098924|NCT02552212|147746815|OTHER||Odds Ratio (OR)|6.223|||<|0.001|TWO_SIDED|95.0|3.8|10.191|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||10.191|3.800|<0.001
74050469|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.695||||0.0125|TWO_SIDED|95.0|0.523|0.925|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.925|0.523|0.0125
74098925|NCT02552212|147746816|OTHER||Difference|-0.183|||<|0.001|TWO_SIDED|95.0|-0.25|-0.117|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-0.117|-0.250|<0.001
74098926|NCT02552212|147746824|OTHER||Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.62|-1.18|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.18|-2.62|<0.001
74098927|NCT02552212|147746825|OTHER||Odds Ratio (OR)|0.484|||=|0.247|TWO_SIDED|95.0|0.142|1.653|||Regression, Logistic|||Odds ratio: CZP/PBO and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||1.653|0.142|=0.247
74098928|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|-2.26|||||TWO_SIDED|95.0|-8.08|2.33||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.33|-8.08|
74098929|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|-0.49|||||TWO_SIDED|95.0|-9.93|8.65||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||8.65|-9.93|
74098930|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|-2.27|||||TWO_SIDED|95.0|-8.07|2.26||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.26|-8.07|
74098931|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|0.68||||||95.0|-4.96|6.16||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.16|-4.96|
74098932|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|-2.25||||||95.0|-8.18|2.36||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.36|-8.18|
74098933|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-4.84|6.32||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.32|-4.84|
74050470|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.472||||0.0139|TWO_SIDED|95.0|1.288|9.357|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||9.357|1.288|0.0139
74050471|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.6327|TWO_SIDED|95.0|0.601|2.311|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (\> 1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.311|0.601|0.6327
74050472|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.061|||<|0.0001|TWO_SIDED|95.0|1.042|1.08|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.080|1.042|<0.0001
74050473|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.185||||0.0033|TWO_SIDED|95.0|1.058|1.326|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.326|1.058|0.0033
74050474|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.227|||<|0.0001|TWO_SIDED|95.0|1.151|1.308|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.308|1.151|<0.0001
74050475|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.814||||0.0289|TWO_SIDED|95.0|0.676|0.979|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, 1st 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.979|0.676|0.0289
74050476|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.276|||<|0.0001|TWO_SIDED|95.0|1.177|1.383|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.383|1.177|<0.0001
74050477|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.894||||0.0099|TWO_SIDED|95.0|0.821|0.973|||Regression, Logistic|||The statistical analysis is presented for Cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.973|0.821|0.0099
74050478|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.945||||0.0058|TWO_SIDED|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.120|1.213|0.0058
74050479|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.262|||<|0.0001|TWO_SIDED|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.380|1.154|<0.0001
74098934|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|-0.69||||||95.0|-7.75|5.86||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||5.86|-7.75|
74098935|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|72.87||||||95.0|63.32|81.07||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||81.07|63.32|
74098936|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|84.92||||||95.0|76.73|91.05||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||91.05|76.73|
74098937|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|57.94||||||95.0|48.01|67.42||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||67.42|48.01|
74098938|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|62.81||||||95.0|52.33|72.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||72.20|52.33|
74098939|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|92.27||||||95.0|85.26|96.54||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||96.54|85.26|
74098940|NCT00205803|147746832|SUPERIORITY_OR_OTHER||Difference|5.61||||||95.0|1.23|11.86||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||11.86|1.23|
74098941|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|-1.5||||||95.0|-7.9|3.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.6|-7.9|
73881398|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.56||||0.36|TWO_SIDED|95.0|0.6|4.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.03|0.60|0.3600
74050480|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.945||||0.0058|TWO_SIDED|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.120|1.213|0.0058
74050481|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.262|||<|0.0001|TWO_SIDED|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.380|1.154|<0.0001
74050482|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.615||||0.0205|TWO_SIDED|95.0|1.219|10.721|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||10.721|1.219|0.0205
74050483|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.981||||0.9557|TWO_SIDED|95.0|0.506|1.903|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.903|0.506|0.9557
74050484|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.599||||0.2|TWO_SIDED|95.0|0.273|1.312|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.312|0.273|0.2000
74050485|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.684||||0.0437|TWO_SIDED|95.0|1.037|13.083|||Regression, Logistic|||The statistical analysis is presented for (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||13.083|1.037|0.0437
74050486|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|134.6|||<|0.0001|TWO_SIDED|95.0|17.956|1009.0|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1009.0|17.956|<0.0001
74050487|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|77.905|||<|0.0001|TWO_SIDED|95.0|10.521|576.85|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||576.85|10.521|<0.0001
74050488|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.527||||0.0105|TWO_SIDED|95.0|1.872|112.73|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||112.73|1.872|0.0105
74050489|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.563||||0.0041|TWO_SIDED|95.0|1.152|2.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.120|1.152|0.0041
74050490|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.557|||<|0.0001|TWO_SIDED|95.0|2.405|12.838|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||12.838|2.405|<0.0001
74050491|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.822||||0.0037|TWO_SIDED|95.0|1.216|2.732|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.732|1.216|0.0037
74050492|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.342|||<|0.0001|TWO_SIDED|95.0|3.977|32.347|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||32.347|3.977|<0.0001
74050493|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112|||<|0.0001|TWO_SIDED|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.158|1.068|<0.0001
74050494|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112|||<|0.0001|TWO_SIDED|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.158|1.068|<0.0001
74098942|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
74098943|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|-1.3||||||95.0|-6.9|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.8|-6.9|
74098944|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
74098945|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.7|3.9||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.9|-4.7|
74098946|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
74098947|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|-2.6|7.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||7.7|-2.6|
74098948|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|97.8||||||95.0|92.3|99.7||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||99.7|92.3|
74098949|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|83.6||||||95.0|73.2|90.8||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||90.8|73.2|
73888122|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|34.6||||0.3418|TWO_SIDED|95.0|-37.1|106.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||106.3|-37.1|0.3418
74098950|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|29.5||||||95.0|19.7|40.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||40.9|19.7|
74098951|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|12.0||||||95.0|5.9|20.4||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||20.4|5.9|
74098952|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|94.1||||||95.0|86.8|98.1||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||98.1|86.8|
74098953|NCT00205803|147746833|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
74098954|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|0.76||||||95.0|0.59|0.96||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.59|
74098955|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.62|1.48||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||1.48|0.62|
74098956|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Difference|0.85||||||95.0|0.69|1.05||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||1.05|0.69|
74098957|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|0.82||||||95.0|0.6|1.11||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.11|0.60|
74098958|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|0.62||||||95.0|0.49|0.79||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||0.79|0.49|
74098959|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|0.86||||||95.0|0.67|1.09||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||1.09|0.67|
74098960|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|0.77||||||95.0|0.59|1.0||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||1.00|0.59|
74098961|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|39.78||||||95.0|27.47|57.63||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated||57.63|27.47|
74098962|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|15.56||||||95.0|11.63|20.81||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated||20.81|11.63|
74098963|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|8.67||||||95.0|6.65|11.29||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated||11.29|6.65|
74098964|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|9.6||||||95.0|7.07|13.04||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated||13.04|7.07|
74098965|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|26.78||||||95.0|20.97|34.22||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated||34.22|20.97|
74098966|NCT00205803|147746834|SUPERIORITY_OR_OTHER||Ratio|1.71||||||95.0|1.36|2.16||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated||2.16|1.36|
74098967|NCT00205803|147746836|SUPERIORITY_OR_OTHER||Difference|3.08||||||95.0|-7.22|13.73||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||13.73|-7.22|
74098968|NCT00205803|147746836|SUPERIORITY_OR_OTHER||Difference|7.02||||||95.0|-7.28|21.14||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||21.14|-7.28|
74098969|NCT00205803|147746836|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated||7.73|-9.38|
74098970|NCT00205803|147746836|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated||7.73|-9.38|
74098971|NCT00205803|147746836|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-5.97|5.68||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||5.68|-5.97|
74050495|NCT01066819|147654179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.921||||0.0035|TWO_SIDED|95.0|1.686|14.362|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||14.362|1.686|0.0035
74050496|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.441||||0.0162|TWO_SIDED|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.859|0.226|0.0162
74050497|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.745||||0.0156|TWO_SIDED|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.741|1.111|0.0156
74050498|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.1075|TWO_SIDED|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for Alanine Aminotransferase (ALT) ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.789|0.829|0.1075
74050499|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.906||||0.8518|TWO_SIDED|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.559|0.321|0.8518
74050500|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969||||0.0012|TWO_SIDED|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.951|0.0012
74050501|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.441||||0.0162|TWO_SIDED|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.859|0.226|0.0162
74098972|NCT00205803|147746836|SUPERIORITY_OR_OTHER||Difference|-1.64||||||95.0|-8.8|4.24||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||4.24|-8.80|
74098973|NCT00205803|147746836|SUPERIORITY_OR_OTHER||Difference|-1.64||||||95.0|-8.8|4.21||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||4.21|-8.80|
74098974|NCT00205803|147746836|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Hepatitis b the difference in percentage between the two groups (13vPnC - 7vPnC) at 10 mIU/mL threshold was calculated||7.73|-9.38|
74098975|NCT00205803|147746836|SUPERIORITY_OR_OTHER||Difference|-1.74||||||95.0|-11.0|6.99||||||For Pertussis - FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 82.00 EU/MI threshold was calculated||6.99|-11.00|
74098976|NCT00205803|147746836|SUPERIORITY_OR_OTHER||Difference|-6.36||||||95.0|-17.03|3.16||||||For Pertussis - PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 43.00 EU/mL threshold was calculated||3.16|-17.03|
74098977|NCT00205803|147746836|SUPERIORITY_OR_OTHER||Difference|1.33||||||95.0|-6.79|9.68||||||For Pertussis - Pertactin the difference in percentage between the two groups (13vPnC - 7vPnC) at 18.00 EU/mL threshold was calculated||9.68|-6.79|
74098978|NCT00205803|147746837|SUPERIORITY_OR_OTHER||Ratio|1.21|||||TWO_SIDED|95.0|0.69|2.14||||||||2.14|0.69|
73888123|NCT01746901|147309536|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.8833|TWO_SIDED|95.0|-77.0|66.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||66.4|-77.0|0.8833
74050502|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.745||||0.0156|TWO_SIDED|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.741|1.111|0.0156
74098979|NCT00205803|147746838|SUPERIORITY_OR_OTHER||Ratio|0.97|||||TWO_SIDED|95.0|0.63|1.48||||||||1.48|0.63|
74098980|NCT00205803|147746839|SUPERIORITY_OR_OTHER||Ratio|0.83|||||TWO_SIDED|95.0|0.57|1.21||||||||1.21|0.57|
74098981|NCT00205803|147746840|SUPERIORITY_OR_OTHER||Ratio|1.01|||||TWO_SIDED|95.0|0.66|1.53||||||Polio Type 1||1.53|0.66|
74098982|NCT00205803|147746840|SUPERIORITY_OR_OTHER||Ratio|0.91|||||TWO_SIDED|95.0|0.56|1.49||||||Polio Type 2||1.49|0.56|
74098983|NCT00205803|147746840|SUPERIORITY_OR_OTHER||Ratio|1.12|||||TWO_SIDED|95.0|0.69|1.84||||||Polio Type 3||1.84|0.69|
74098984|NCT00205803|147746841|SUPERIORITY_OR_OTHER||Ratio|0.92|||||TWO_SIDED|95.0|0.74|1.15||||||Pertussis - FHA||1.15|0.74|
74098985|NCT00205803|147746841|SUPERIORITY_OR_OTHER||Ratio|1.02|||||TWO_SIDED|95.0|0.83|1.25||||||Pertussis - PT||1.25|0.83|
74098986|NCT00205803|147746841|SUPERIORITY_OR_OTHER||Ratio|1.04|||||TWO_SIDED|95.0|0.76|1.44||||||Pertussis - Pertactin||1.44|0.76|
74098987|NCT04080544|147746891|OTHER|Null-hypothesis significance testing|Slope|-1.42|STANDARD_ERROR_OF_MEAN|0.81||0.081|TWO_SIDED|95.0|-3.03|0.18||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to episodic memory.||0.18|-3.03|.081
74050503|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.1075|TWO_SIDED|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.789|0.829|0.1075
74050504|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.906||||0.8518|TWO_SIDED|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.559|0.321|0.8518
74050505|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969||||0.0012|TWO_SIDED|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.951|0.0012
74050506|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.848||||0.0017|TWO_SIDED|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.940|0.765|0.0017
74050507|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.848||||0.0017|TWO_SIDED|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.940|0.765|0.0017
74050508|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.401||||0.0071|TWO_SIDED|95.0|0.206|0.78|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.780|0.206|0.0071
74050509|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.016||||0.0006|TWO_SIDED|95.0|0.001|0.169|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.169|0.001|0.0006
74050510|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.076||||0.0255|TWO_SIDED|95.0|0.008|0.729|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.729|0.008|0.0255
74050511|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.184||||0.1501|TWO_SIDED|95.0|0.018|1.845|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.845|0.018|0.1501
74050512|NCT01066819|147654196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.25|||<|0.0001|TWO_SIDED|95.0|6.729|110.35|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs RVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||110.35|6.729|<0.0001
74098988|NCT04080544|147746891|OTHER|Null-hypothesis significance test|Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.604|TWO_SIDED|95.0|-0.32|0.19||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of episodic memory.||0.19|-0.32|.604
74050513|NCT03894501|147654244|SUPERIORITY|||||||0.048|||||||ANOVA|||||||.048
74050514|NCT03894501|147654245|SUPERIORITY|||||||0.037|||||||ANCOVA|||||||.037
74050515|NCT03894501|147654246|SUPERIORITY|||||||0.024|||||||ANCOVA|||||||.024
74098989|NCT04080544|147746892|OTHER|Null-hypothesis significance test|Slope|1.77|STANDARD_ERROR_OF_MEAN|0.81||0.033|TWO_SIDED|95.0|0.15|3.39||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for baseline age, sex, and years of education.||Regression testing the relationship between amyloid accumulation (annualized change score for amyloid SUVR) to temporal tau SUVR.||3.39|0.15|.033
74050516|NCT03894501|147654247|SUPERIORITY|||||||0.005|||||||ANCOVA|||||||.005
74050517|NCT03894501|147654248|SUPERIORITY|||||||0.013|||||||ANOVA|||||||.013
74050518|NCT03894501|147654249|SUPERIORITY|||||||0.035|||||||ANOVA|||||||.035
74050519|NCT00779116|147654282|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Statistical tests were performed atthe significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.||||<0.0001
74050520|NCT04652102|147654293|SUPERIORITY||Proportion|0.364|||||TWO_SIDED|95.826|0.299|0.433|||||Derived from an exact 2-sided 95.826% Pearson-Clopper confidence interval (CI) on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.433|0.299|
74098990|NCT04080544|147746893|OTHER|Null-hypothesis significance testing|Slope|0.272|STANDARD_ERROR_OF_MEAN|0.7||0.699|TWO_SIDED|95.0|-1.12|1.66||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to speed of processing.||1.66|-1.12|.699
74098991|NCT04080544|147746893|OTHER|Null-hypothesis significance test|Slope|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.154|TWO_SIDED|95.0|-0.06|0.38||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in the prediction of speed of processing.||0.38|-0.06|.154
74098992|NCT04080544|147746894|OTHER|Null-hypothesis significance testing|Slope|-1.11|STANDARD_ERROR_OF_MEAN|0.74||0.137|TWO_SIDED|95.0|-2.58|0.36||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to reasoning function.||0.36|-2.58|.137
74019049|NCT01162421|147590208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.132||0.194|TWO_SIDED|95.0|-0.44|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||0.09|-0.44|0.194
74019050|NCT01162421|147590208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.132||0.863|TWO_SIDED|95.0|-0.24|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.29|-0.24|0.863
74019051|NCT01162421|147590208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.129||0.452|TWO_SIDED|95.0|-0.16|0.35||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.35|-0.16|0.452
74019052|NCT01162421|147590208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.141||0.738|TWO_SIDED|95.0|-0.23|0.33||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.33|-0.23|0.738
74019053|NCT01162421|147590208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.148||0.572|TWO_SIDED|95.0|-0.21|0.38||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.38|-0.21|0.572
74019054|NCT01162421|147590209|SUPERIORITY_OR_OTHER||Difference in percentage|-11.9||||0.299|TWO_SIDED|95.0|-34.05|10.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||10.31|-34.05|0.299
74019055|NCT01162421|147590209|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0||||0.796|TWO_SIDED|95.0|-25.77|19.77|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||19.77|-25.77|0.796
74019056|NCT01162421|147590209|SUPERIORITY_OR_OTHER||Difference in percentage|7.0||||0.54|TWO_SIDED|95.0|-15.3|29.22|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||29.22|-15.30|0.540
74019057|NCT01162421|147590209|SUPERIORITY_OR_OTHER||Difference in percentage|-9.6||||0.392|TWO_SIDED|95.0|-31.39|12.19|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||12.19|-31.39|0.392
74019058|NCT01162421|147590209|SUPERIORITY_OR_OTHER||Difference in percentage|-3.3||||0.776|TWO_SIDED|95.0|-25.96|19.37|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||19.37|-25.96|0.776
74019059|NCT01162421|147590209|SUPERIORITY_OR_OTHER||Difference in percentage|-16.1||||0.166|TWO_SIDED|95.0|-38.64|6.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||6.40|-38.64|0.166
74019060|NCT01162421|147590210|SUPERIORITY_OR_OTHER||Difference in percentage|-10.9||||0.283|TWO_SIDED|95.0|-30.84|9.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||9.01|-30.84|0.283
74019061|NCT01162421|147590210|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.444|TWO_SIDED|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||28.00|-12.17|0.444
74019062|NCT01162421|147590210|SUPERIORITY_OR_OTHER||Difference in percentage|1.6||||0.885|TWO_SIDED|95.0|-20.16|23.38|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||23.38|-20.16|0.885
74019063|NCT01162421|147590210|SUPERIORITY_OR_OTHER||Difference in percentage|-1.0||||0.931|TWO_SIDED|95.0|-22.54|20.64|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||20.64|-22.54|0.931
74019064|NCT01162421|147590210|SUPERIORITY_OR_OTHER||Difference in percentage|2.2||||0.836|TWO_SIDED|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||23.03|-18.63|0.836
74019065|NCT01162421|147590210|SUPERIORITY_OR_OTHER||Difference in percentage|2.2||||0.836|TWO_SIDED|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||23.03|-18.63|0.836
74019066|NCT01162421|147590211|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.25||0.699|TWO_SIDED|95.0|-3.6|5.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||5.4|-3.6|0.699
74019067|NCT01162421|147590211|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|2.45||0.261|TWO_SIDED|95.0|-2.1|7.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||7.7|-2.1|0.261
74019068|NCT01162421|147590211|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.36||0.514|TWO_SIDED|95.0|-6.2|3.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||3.2|-6.2|0.514
74019069|NCT01162421|147590211|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|2.5||0.283|TWO_SIDED|95.0|-7.7|2.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||2.3|-7.7|0.283
74019070|NCT01162421|147590211|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.75||0.461|TWO_SIDED|95.0|-7.5|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||3.4|-7.5|0.461
74019071|NCT01162421|147590211|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.703|TWO_SIDED|95.0|-6.6|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||4.5|-6.6|0.703
74019072|NCT01162421|147590212|SUPERIORITY_OR_OTHER||Difference in percentage|-1.1||||1|TWO_SIDED|95.0|-17.94|15.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 3||15.16|-17.94|1.000
74019073|NCT01162421|147590212|SUPERIORITY_OR_OTHER||Difference in percentage|-6.4||||0.468|TWO_SIDED|95.0|-22.34|8.81|||Fisher Exact|Two-sided Fisher Exact test.||Month 6||8.81|-22.34|0.468
74019074|NCT01162421|147590212|SUPERIORITY_OR_OTHER||Difference in percentage|-11.9||||0.142|TWO_SIDED|95.0|-27.88|3.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 9||3.16|-27.88|0.142
74019075|NCT01162421|147590212|SUPERIORITY_OR_OTHER||Difference in percentage|4.6||||0.712|TWO_SIDED|95.0|-11.08|19.83|||Fisher Exact|Two-sided Fisher Exact test.||Month 12||19.83|-11.08|0.712
74019076|NCT01162421|147590212|SUPERIORITY_OR_OTHER||Difference in percentage|7.2||||0.482|TWO_SIDED|95.0|-8.92|22.89|||Fisher Exact|Two-sided Fisher Exact test.||Month 18||22.89|-8.92|0.482
74019077|NCT01162421|147590212|SUPERIORITY_OR_OTHER||Difference in percentage|-6.2||||0.418|TWO_SIDED|95.0|-21.18|7.69|||Fisher Exact|Two-sided Fisher Exact test.||Month 24||7.69|-21.18|0.418
74019078|NCT01162421|147590213|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|5.86||0.453|TWO_SIDED|95.0|-16.3|7.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.4|-16.3|0.453
74019079|NCT01162421|147590213|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|5.88||0.187|TWO_SIDED|95.0|-19.7|4.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||4.0|-19.7|0.187
74019080|NCT01162421|147590213|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|6.31||0.598|TWO_SIDED|95.0|-16.1|9.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||9.4|-16.1|0.598
74019081|NCT01162421|147590213|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|5.75||0.558|TWO_SIDED|95.0|-8.2|15.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||15.0|-8.2|0.558
74019082|NCT01162421|147590213|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|6.4||0.669|TWO_SIDED|95.0|-10.1|15.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||15.6|-10.1|0.669
74019083|NCT01162421|147590213|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|6.16||0.865|TWO_SIDED|95.0|-11.3|13.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||13.5|-11.3|0.865
74019084|NCT01162421|147590214|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.058||0.809|TWO_SIDED|95.0|-0.1|0.13||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||0.13|-0.10|0.809
74019085|NCT01162421|147590214|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.062||0.447|TWO_SIDED|95.0|-0.08|0.17||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||0.17|-0.08|0.447
74019086|NCT01162421|147590214|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.062||0.579|TWO_SIDED|95.0|-0.16|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.09|-0.16|0.579
74019087|NCT01162421|147590214|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.057||0.922|TWO_SIDED|95.0|-0.11|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.12|-0.11|0.922
74019088|NCT01162421|147590214|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.064||0.894|TWO_SIDED|95.0|-0.14|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.12|-0.14|0.894
74019089|NCT01162421|147590214|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.611|TWO_SIDED|95.0|-0.17|0.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.10|-0.17|0.611
74019090|NCT01162421|147590215|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.42||0.572|TWO_SIDED|95.0|-11.3|6.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||6.3|-11.3|0.572
74019091|NCT01162421|147590215|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|5.15||0.13|TWO_SIDED|95.0|-2.4|18.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||18.2|-2.4|0.130
74019092|NCT01162421|147590215|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.26||0.649|TWO_SIDED|95.0|-12.9|8.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||8.1|-12.9|0.649
74019093|NCT01162421|147590215|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|4.8||0.579|TWO_SIDED|95.0|-12.3|6.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||6.9|-12.3|0.579
74019094|NCT01162421|147590215|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.03||0.826|TWO_SIDED|95.0|-11.1|8.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||8.9|-11.1|0.826
74019095|NCT01162421|147590215|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.72||0.675|TWO_SIDED|95.0|-13.8|9.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||9.0|-13.8|0.675
74019096|NCT01162421|147590216|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.57||0.458|TWO_SIDED|95.0|-2.0|4.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||4.3|-2.0|0.458
74050521|NCT04652102|147654293|OTHER||Vaccine Efficacy|48.2||||0.016|TWO_SIDED|95.826|31.0|61.4||1-sided p-value from the exact binomial test on proportion of cases coming from the CVnCoV group among all cases (equivalent to a test on VE with H0: VE ≤30%). Statistically significant if lower than 0.02087.|Exact Binomial Test||2-sided 95.826% CI on VE, derived from the exact 2-sided 95.826% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Vaccine efficacy (VE) calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||61.4|31.0|0.01600
74050522|NCT04652102|147654305|SUPERIORITY||Proportion|0.245|||||TWO_SIDED|95.0|0.133|0.389|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.389|0.133|
74050523|NCT04652102|147654305|SUPERIORITY||Vaccine Efficacy|70.7|||||TWO_SIDED|95.0|42.5|86.1|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||86.1|42.5|
74050524|NCT04652102|147654306|SUPERIORITY||Proportion|0.286|||||TWO_SIDED|95.0|0.084|0.581|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.581|0.084|
74050525|NCT04652102|147654306|SUPERIORITY||Vaccine Efficacy|63.8|||||TWO_SIDED|95.0|-25.5|91.7|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||91.7|-25.5|
74098993|NCT04080544|147746894|OTHER|Null-hypothesis significance test|Slope|0.11|STANDARD_ERROR_OF_MEAN|0.13||0.428|TWO_SIDED|95.0|-0.16|0.37||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of reasoning.||0.37|-0.16|.428
74098994|NCT04080544|147746895|OTHER|Null-hypothesis significance test|Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.78||0.376|TWO_SIDED|95.0|-2.25|0.86||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to working memory.||0.86|-2.25|.376
74050526|NCT04652102|147654307|SUPERIORITY||Proportion|0.341|||||TWO_SIDED|95.0|0.242|0.452|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.452|0.242|
74050527|NCT04652102|147654307|SUPERIORITY||Vaccine Efficacy|53.2|||||TWO_SIDED|95.0|25.4|71.2|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||71.2|25.4|
74050528|NCT04652102|147654308|SUPERIORITY||Proportion|0.571|||||TWO_SIDED|95.0|0.34|0.782|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.782|0.340|
74050529|NCT04652102|147654308|SUPERIORITY||Vaccine Efficacy|-11.8|||||TWO_SIDED|95.0|-200.5|56.7|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||56.7|-200.5|
74050530|NCT00266799|147654315|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.08||||0.6686|TWO_SIDED|95.0|0.76|1.54|||Log Rank|||By Investigator Assessment of ITT Population||1.54|0.76|0.6686
74050531|NCT00266799|147654315|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.15||||0.4472|TWO_SIDED|95.0|0.8|1.65|||Log Rank|||By RECIST Criteria of ITT Population||1.65|0.80|0.4472
74098995|NCT04080544|147746895|OTHER|Null-hypothesis significance test|Slope|0.27|STANDARD_ERROR_OF_MEAN|0.13||0.039|TWO_SIDED|95.0|0.01|0.53||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of working memory.||0.53|0.01|.039
74050532|NCT00266799|147654315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.5508|TWO_SIDED|95.0|0.74|1.77|||Log Rank|||By Investigator Assessment of TTP Population||1.77|0.74|0.5508
74050533|NCT00266799|147654315|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.4088|TWO_SIDED|95.0|0.77|1.89|||Log Rank|||By RECIST Criteria of TTP Population||1.89|0.77|0.4088
74050534|NCT00266799|147654316|SUPERIORITY_OR_OTHER|||||||0.1726||95.0|||||Chi-squared|||By Investigator Assessment||||0.1726
74050535|NCT00266799|147654316|SUPERIORITY_OR_OTHER|||||||0.6541||95.0|||||Chi-squared|||By RECIST Criteria||||0.6541
74050536|NCT00266799|147654317|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.5265|TWO_SIDED|95.0|0.79|1.58|||Log Rank|||||1.58|0.79|0.5265
74050537|NCT00266799|147654318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0841||95.0|||||Log Rank|p-value also given for Hazard Ratio||||||0.0841
74050538|NCT00696774|147654323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.005|TWO_SIDED|95.0|-1.12|-0.2|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.20|-1.12|0.005
74050539|NCT00696774|147654325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|||||TWO_SIDED|95.0|-7.34|-4.36|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-4.36|-7.34|
74050540|NCT00696774|147654326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47|||||TWO_SIDED|95.0|-3.13|-1.81|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.81|-3.13|
74050541|NCT00696774|147654327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.29|||||TWO_SIDED|95.0|-4.1|-2.48|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-2.48|-4.10|
74050542|NCT00696774|147654328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22|||||TWO_SIDED|95.0|-2.89|-1.54|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.54|-2.89|
74050543|NCT00696774|147654329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-2.45|-1.3|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.30|-2.45|
74050544|NCT00696774|147654330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||||TWO_SIDED|95.0|-1.31|-0.63|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.63|-1.31|
74050545|NCT00696774|147654331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.42|||||TWO_SIDED|95.0|-6.04|-2.8|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-2.80|-6.04|
74050546|NCT00696774|147654332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|||||TWO_SIDED|95.0|-1.42|-0.84|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.84|-1.42|
74050547|NCT00696774|147654333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||||TWO_SIDED|95.0|-1.08|-0.24|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.24|-1.08|
74050548|NCT00696774|147654334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.81|-0.18|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.18|-0.81|
74050549|NCT00696774|147654335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|||||TWO_SIDED|95.0|-0.99|2.6|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||2.60|-0.99|
74050550|NCT00696774|147654335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|||||TWO_SIDED|95.0|-0.69|3.42|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||3.42|-0.69|
74050551|NCT00696774|147654336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.05|||||TWO_SIDED|95.0|10.63|19.47|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||19.47|10.63|
73888124|NCT01746901|147309537|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.6||||0.0041|TWO_SIDED|95.0|-6.1|-1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.2|-6.1|0.0041
74050552|NCT00696774|147654336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.48|||||TWO_SIDED|95.0|4.72|16.24|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||16.24|4.72|
74050553|NCT00696774|147654337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||||TWO_SIDED|95.0|-7.75|-4.02|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||-4.02|-7.75|
74050554|NCT00696774|147654337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.59|||||TWO_SIDED|95.0|-6.65|-2.54|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||-2.54|-6.65|
74050555|NCT02442765|147654338|SUPERIORITY||Least Squares Mean Difference|-4.0|||=|0.021|TWO_SIDED|95.0|-7.4|-0.6||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|mixed model repeated measures (MMRM)|||||-0.6|-7.4|=0.021
74050556|NCT02442765|147654338|SUPERIORITY||Least Squares Mean Difference|-0.6|||=|0.731|TWO_SIDED|95.0|-3.9|2.7||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|||||2.7|-3.9|=0.731
74050557|NCT02442765|147654338|SUPERIORITY||Least Squares Mean Difference|-3.5|||=|0.157|TWO_SIDED|95.0|-8.4|1.4||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|||||1.4|-8.4|=0.157
74050558|NCT02442765|147654338|SUPERIORITY||Least Squares Mean Difference|-3.6|||=|0.15|TWO_SIDED|95.0|-8.4|1.3||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.3|-8.4|=0.150
74050559|NCT02442765|147654338|SUPERIORITY||MMRM weighted z-statistic|-2.65|||=|0.008|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|Sequential Parallel Comparison Design (SPCD) was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||||=0.008
74050560|NCT02442765|147654338|SUPERIORITY||MMRM weighted z-statistic|-1.26|||=|0.208|TWO_SIDED|||||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|SPCD was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||||=0.208
74050561|NCT02442765|147654339|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.331|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.331
74050562|NCT02442765|147654339|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.4|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.400
74050563|NCT02442765|147654339|SUPERIORITY||Least Squares Mean Difference|-0.6||||0.014|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||||-0.1|-1.1|0.014
74050564|NCT02442765|147654339|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.145|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.145
74050565|NCT02442765|147654339|SUPERIORITY||SPCD OLS weighted z-statistic|-2.51||||0.012|TWO_SIDED||||||ANCOVA||OLS = ordinary least squares|||||0.012
74050566|NCT02442765|147654339|SUPERIORITY||SPCD OLS weighted z-statistic|-1.66||||0.097|TWO_SIDED||||||ANCOVA|||||||0.097
74050567|NCT02442765|147654340|SUPERIORITY||Least Squares Mean Difference|-0.5|||=|0.182|TWO_SIDED|95.0|-1.3|0.2||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|SPCD was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||0.2|-1.3|=0.182
74050568|NCT02442765|147654340|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.39|TWO_SIDED|95.0|-1.1|0.4||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.4|-1.1|=0.390
74050569|NCT02442765|147654340|SUPERIORITY||Least Squares Mean Difference|0.5|||=|0.462|TWO_SIDED|95.0|-0.8|1.7||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.7|-0.8|=0.462
74050570|NCT02442765|147654340|SUPERIORITY||Least Squares Mean Difference|0.4|||=|0.528|TWO_SIDED|95.0|-0.8|1.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.6|-0.8|=0.528
74050571|NCT02442765|147654340|SUPERIORITY||MMRM weighted z-statistic|-0.39|||=|0.695|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, Baseline (BL), BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|ANCOVA|||||||=0.695
74050572|NCT02442765|147654340|SUPERIORITY||MMRM weighted z-statistic|-0.12|||=|0.904|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, Baseline (BL), BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|ANCOVA|||||||=0.904
74050573|NCT02442765|147654341|SUPERIORITY||Least Squares Mean Difference|-1.2|||=|0.247|TWO_SIDED|95.0|-3.2|0.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.8|-3.2|=0.247
74050574|NCT02442765|147654341|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.721|TWO_SIDED|95.0|-2.3|1.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.6|-2.3|=0.721
74050575|NCT02442765|147654341|SUPERIORITY||Least Squares Mean Difference|-1.2|||=|0.419|TWO_SIDED|95.0|-4.3|1.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.8|-4.3|=0.419
74050576|NCT02442765|147654341|SUPERIORITY||Least Squares Mean Difference|0.9|||=|0.534|TWO_SIDED|95.0|-2.0|3.9||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||3.9|-2.0|=0.534
74050577|NCT02442765|147654341|SUPERIORITY||MMRM weighted z-statistic|-1.4|||=|0.163|TWO_SIDED||||||ANCOVA|||||||=0.163
74050578|NCT02442765|147654341|SUPERIORITY||MMRM weighted z-statistic|0.19|||=|0.851|TWO_SIDED||||||ANCOVA|||||||=0.851
74050579|NCT02442765|147654342|SUPERIORITY||Least Squares Mean Difference|-0.6|||=|0.146|TWO_SIDED|95.0|-1.4|0.2||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.2|-1.4|=0.146
74050580|NCT02442765|147654342|SUPERIORITY||Least Squares Mean Difference|0.3|||=|0.399|TWO_SIDED|95.0|-0.4|1.1||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.1|-0.4|=0.399
74050581|NCT02442765|147654342|SUPERIORITY||Least Squares Mean Difference|0.7|||=|0.283|TWO_SIDED|95.0|-0.6|2.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.0|-0.6|=0.283
74050582|NCT02442765|147654342|SUPERIORITY||Least Squares Mean Difference|1.2|||=|0.065|TWO_SIDED|95.0|-0.1|2.5||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.5|-0.1|=0.065
74050583|NCT02442765|147654342|SUPERIORITY||MMRM weighted z-statistic|-0.22|||=|0.829|TWO_SIDED||||||ANCOVA|||||||=0.829
74050584|NCT02442765|147654342|SUPERIORITY||MMRM weighted z-statistic|1.94|||=|0.052|TWO_SIDED||||||ANCOVA|||||||=0.052
74050585|NCT02442765|147654343|SUPERIORITY||Least Squares Mean Difference|-0.7|||=|0.53|TWO_SIDED|95.0|-2.7|1.4|||ANCOVA|||||1.4|-2.7|=0.530
74050586|NCT02442765|147654343|SUPERIORITY||Least Squares Mean Difference|-1.0|||=|0.326|TWO_SIDED|95.0|-3.1|1.0|||ANCOVA|||||1.0|-3.1|=0.326
74050587|NCT02442765|147654343|SUPERIORITY||Least Squares Mean Difference|2.5|||=|0.135|TWO_SIDED|95.0|-0.8|5.9|||ANCOVA|||||5.9|-0.8|=0.135
74098996|NCT04080544|147746895|OTHER|Null-hypothesis significance test|Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.27||0.091|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at 1SD below the mean for amyloid||||.091
74098997|NCT04080544|147746895|OTHER|Null-hypothesis significance test|Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.296|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at the mean for amyloid SUVR||||.296
74050588|NCT02442765|147654343|SUPERIORITY||Least Squares Mean Difference|0.2|||=|0.895|TWO_SIDED|95.0|-3.1|3.5|||ANCOVA|||||3.5|-3.1|=0.895
74050589|NCT02442765|147654343|SUPERIORITY||SPCD OLS weighted Z-statistic|0.67|||=|0.502|TWO_SIDED||||||ANCOVA|||||||=0.502
74050590|NCT02442765|147654343|SUPERIORITY||SPCD OLS weighted Z-statistic|-0.58|||=|0.564|TWO_SIDED||||||ANCOVA|||||||=0.564
74050591|NCT02442765|147654344|SUPERIORITY||Least Squares Mean Difference|-0.8|||=|0.061|TWO_SIDED|95.0|-1.6|0.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.0|-1.6|=0.061
74050592|NCT02442765|147654344|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.4|TWO_SIDED|95.0|-1.1|0.5||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.5|-1.1|=0.400
74050593|NCT02442765|147654344|SUPERIORITY||Least Squares Mean Difference|-1.1|||=|0.115|TWO_SIDED|95.0|-2.4|0.3||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.3|-2.4|=0.115
74050594|NCT02442765|147654344|SUPERIORITY||Least Squares Mean Difference|-0.8|||=|0.264|TWO_SIDED|95.0|-2.1|0.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.6|-2.1|=0.264
74050595|NCT02442765|147654344|SUPERIORITY||MMRM weighted z-statistic|-2.44|||=|0.015|TWO_SIDED||||||ANCOVA|||||||=0.015
74050596|NCT02442765|147654344|SUPERIORITY||MMRM weighted z-statistic|-1.4|||=|0.163|TWO_SIDED||||||ANCOVA|||||||=0.163
74050597|NCT02442765|147654345|SUPERIORITY||Least Squares Mean Difference|-3.9|||=|0.05|TWO_SIDED|95.0|-7.8|0.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||-0.0|-7.8|=0.050
74050598|NCT02442765|147654345|SUPERIORITY||Least Squares Mean Difference|-1.6|||=|0.412|TWO_SIDED|95.0|-5.4|2.2||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.2|-5.4|=0.412
74050599|NCT02442765|147654345|SUPERIORITY||Least Squares Mean Difference|-1.0|||=|0.775|TWO_SIDED|95.0|-7.8|5.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||5.8|-7.8|=0.775
74050600|NCT02442765|147654345|SUPERIORITY||Least Squares Mean Difference|3.3|||=|0.333|TWO_SIDED|95.0|-3.5|10.1||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||10.1|-3.5|=0.333
74050601|NCT02442765|147654345|SUPERIORITY||MMRM weighted z-statistic|-1.5|||=|0.133|TWO_SIDED||||||ANCOVA|||||||=0.133
74050602|NCT02442765|147654345|SUPERIORITY||MMRM weighted z-statistic|0.22|||=|0.829|TWO_SIDED||||||ANCOVA|||||||=0.829
74050603|NCT02442765|147654346|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.118|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|=0.118
74050604|NCT02442765|147654346|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.191|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|=0.191
74050605|NCT02442765|147654346|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.225|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.225
74050606|NCT02442765|147654346|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.227|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.227
74050607|NCT02442765|147654346|SUPERIORITY||SPCD OLS weighted z-statistic|-1.97|||=|0.049|TWO_SIDED||||||ANCOVA|||||||=0.049
74050608|NCT02442765|147654346|SUPERIORITY||SPCD OLS weighted z-statistic|-1.78|||=|0.075|TWO_SIDED||||||ANCOVA|||||||=0.075
74050609|NCT02442765|147654347|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.364|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|=0.364
74050610|NCT02442765|147654347|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.427|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|=0.427
74098998|NCT04080544|147746895|OTHER|Null-hypothesis significance test|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.695|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at 1SD above the mean for amyloid SUVR||||.695
74098999|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.012|TWO_SIDED|95.0|0.0004|0.004||A prior threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to inferior temporal SUVR.||0.004|0.0004|.012
74099000|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|-0.000005|STANDARD_ERROR_OF_MEAN|0.00004||0.905|TWO_SIDED|95.0|-0.000009|0.00008||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to inferior temporal SUVR.||0.00008|-0.000009|.905
74099001|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.006|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to inferior temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.006
74099002|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.018|TWO_SIDED|95.0|0.0003|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to middle temporal gyrus SUVR.||0.003|0.0003|.018
74099003|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|-0.00002|STANDARD_ERROR_OF_MEAN|0.00004||0.579|TWO_SIDED|95.0|-0.0001|0.00006||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustment for multiple comparisons.||Regression testing the relationship of age(quadratic) to middle temporal SUVR.||0.00006|-0.0001|.579
74050611|NCT02442765|147654347|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.098|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|=0.098
74050612|NCT02442765|147654347|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.168|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|=0.168
74050613|NCT02442765|147654347|SUPERIORITY||SPCD OLS weighted z-statistic|-1.86|||=|0.063|TWO_SIDED||||||ANCOVA|||||||=0.063
74050614|NCT02442765|147654347|SUPERIORITY||SPCD OLS weighted z-statistic|-1.57|||=|0.115|TWO_SIDED||||||ANCOVA|||||||=0.115
74050615|NCT02442765|147654348|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.014|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|=0.014
74050616|NCT02442765|147654348|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.111|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.111
74050617|NCT02442765|147654348|SUPERIORITY||Least Squares Mean Difference|-0.5|||=|0.062|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||||0.0|-1.1|=0.062
74050618|NCT02442765|147654348|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.305|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|=0.305
74050619|NCT02442765|147654348|SUPERIORITY||SPCD OLS weighted z-statistic|-3.01|||=|0.003|TWO_SIDED||||||ANCOVA|||||||=0.003
74050620|NCT02442765|147654348|SUPERIORITY||SPCD OLS weighted z-statistic|-1.79|||=|0.073|TWO_SIDED||||||ANCOVA|||||||=0.073
74050621|NCT02442765|147654349|SUPERIORITY||Least Squares Mean Difference|0.1|||=|0.909|TWO_SIDED|95.0|-2.2|2.5|||ANCOVA|||||2.5|-2.2|=0.909
74050622|NCT02442765|147654349|SUPERIORITY||Least Squares Mean Difference|1.4|||=|0.226|TWO_SIDED|95.0|-0.9|3.8|||ANCOVA|||||3.8|-0.9|=0.226
74050623|NCT02442765|147654349|SUPERIORITY||Least Squares Mean Difference|2.1|||=|0.405|TWO_SIDED|95.0|-2.9|7.1|||ANCOVA|||||7.1|-2.9|=0.405
74050624|NCT02442765|147654349|SUPERIORITY||Least Squares Mean Difference|-0.9|||=|0.714|TWO_SIDED|95.0|-5.8|4.0|||ANCOVA|||||4.0|-5.8|=0.714
74050625|NCT02442765|147654349|SUPERIORITY||SPCD OLS weighted z-statistic|0.75|||=|0.456|TWO_SIDED||||||ANCOVA|||||||=0.456
74050626|NCT02442765|147654349|SUPERIORITY||SPCD OLS weighted z-statistic|0.42|||=|0.678|TWO_SIDED||||||ANCOVA|||||||=0.678
74050627|NCT02442765|147654350|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.278|TWO_SIDED|95.0|-1.1|0.3|||ANCOVA|||||0.3|-1.1|=0.278
74050628|NCT02442765|147654350|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.817|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|=0.817
74050629|NCT02442765|147654350|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.5|TWO_SIDED|95.0|-1.4|0.7|||ANCOVA|||||0.7|-1.4|=0.500
74050630|NCT02442765|147654350|SUPERIORITY||Least Squares Mean Difference|0.1|||=|0.795|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||||1.2|-0.9|=0.795
74050631|NCT02442765|147654350|SUPERIORITY||SPCD OLS weighted z-statistic|-1.25|||=|0.213|TWO_SIDED||||||ANCOVA|||||||=0.213
74050632|NCT02442765|147654350|SUPERIORITY||SPCD OLS weighted z-statistic|0.02|||=|0.985|TWO_SIDED||||||ANCOVA|||||||=0.985
74050633|NCT02442765|147654352|SUPERIORITY||Least Squares Mean Difference|-1.6|||=|0.018|TWO_SIDED|95.0|-2.9|-0.3|||ANCOVA|||||-0.3|-2.9|=0.018
74050634|NCT02442765|147654352|SUPERIORITY||Least Squares Mean Difference|0.0|||=|0.956|TWO_SIDED|95.0|-1.3|1.3|||ANCOVA|||||1.3|-1.3|=0.956
74050635|NCT02442765|147654352|SUPERIORITY||Least Squares Mean Difference|1.1|||=|0.451|TWO_SIDED|95.0|-1.8|4.0|||ANCOVA|||||4.0|-1.8|=0.451
74099004|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.008|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to middle temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.008
74019097|NCT01162421|147590216|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.76||0.419|TWO_SIDED|95.0|-4.9|2.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||2.1|-4.9|0.419
74099005|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.00006|STANDARD_ERROR_OF_MEAN|0.0004||0.897|TWO_SIDED|95.0|-0.001|0.001||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age to superior temporal SUVR.||0.001|-0.001|.897
74099006|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|-0.00002|STANDARD_ERROR_OF_MEAN|0.00003||0.539|TWO_SIDED|95.0|-0.00007|0.00003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to superior temporal SUVR.||0.00003|-0.00007|.539
74099007|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|-0.00001|STANDARD_ERROR_OF_MEAN|0.0004||0.973|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to superior temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.973
74099008|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.2|TWO_SIDED|95.0|-0.001|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to entorhinal SUVR.||0.003|-0.001|.200
74099009|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.00005|STANDARD_ERROR_OF_MEAN|0.00005||0.346|TWO_SIDED|95.0|-0.00005|0.0001||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to entorhinal SUVR.||0.0001|-0.00005|.346
74019098|NCT01162421|147590216|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.42||0.692|TWO_SIDED|95.0|-2.3|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||3.4|-2.3|0.692
74019099|NCT01162421|147590216|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.69||0.357|TWO_SIDED|95.0|-1.8|5.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||5.0|-1.8|0.357
74019100|NCT01162421|147590216|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.42|TWO_SIDED|95.0|-2.0|4.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||4.7|-2.0|0.420
74019101|NCT01162421|147590216|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.58||0.38|TWO_SIDED|95.0|-1.8|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||4.5|-1.8|0.380
74019102|NCT01162421|147590217|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.046|TWO_SIDED|95.0|0.0|1.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||1.1|0.0|0.046
74019103|NCT01162421|147590217|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.27||0.003|TWO_SIDED|95.0|0.3|1.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6||1.3|0.3|0.003
74019104|NCT01162421|147590217|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.24||0.204|TWO_SIDED|95.0|-0.2|0.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.8|-0.2|0.204
74019105|NCT01162421|147590217|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.227|TWO_SIDED|95.0|-0.2|0.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.7|-0.2|0.227
74019106|NCT01162421|147590217|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.86|TWO_SIDED|95.0|-0.4|0.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.5|-0.4|0.860
74019107|NCT01162421|147590217|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.476|TWO_SIDED|95.0|-0.3|0.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.6|-0.3|0.476
74019108|NCT01107444|147590229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||||||The t-test was based on the logarithm of the ratio of tumor size at Cycle 2 to that at baseline as this measure follows a normal distribution.|t-test, 1 sided|||||||0.284
74099010|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.283|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing relationship of age(growth model) to entorhinal SUVR. Growth modeling was performed using SPSS curve estimation.||||.283
74099011|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.011|TWO_SIDED|95.0|0.0004|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to parahippocampal SUVR.||0.003|0.0004|.011
74019109|NCT00091832|147590245|SUPERIORITY_OR_OTHER|||||||0.245|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||||||0.245
74019110|NCT00091832|147590246|SUPERIORITY_OR_OTHER|||||||0.848|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||||||0.848
74019111|NCT00091832|147590247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||||95.0|0.68|4.35|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.35|0.68|
74050636|NCT02442765|147654352|SUPERIORITY||Least Squares Mean Difference|0.9|||=|0.519|TWO_SIDED|95.0|-1.9|3.7|||ANCOVA|||||3.7|-1.9|=0.519
74050637|NCT02442765|147654352|SUPERIORITY||SPCD OLS weighted z-statistic|-0.72|||=|0.471|TWO_SIDED||||||ANCOVA|||||||=0.471
74050638|NCT02442765|147654352|SUPERIORITY||SPCD OLS weighted z-statistic|0.5|||=|0.618|TWO_SIDED||||||ANCOVA|||||||=0.618
74050639|NCT01200758|147654360|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior Ctrough in SC formulation was demonstrated, if the lower bound of 90% confidence interval (CI) was above 0.8.|Geometric mean ratio|1.62|||||TWO_SIDED|90.0|1.36|1.94|||||Geometric mean ratio adjusted for tumor load at baseline.|||1.94|1.36|
74050640|NCT01200758|147654361|SUPERIORITY_OR_OTHER||Difference in response rates|-4.82||||0.2835|TWO_SIDED|95.0|-14.0|4.4|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||4.4|-14.0|0.2835
74050641|NCT01200758|147654361|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.38|1.33||||||||1.33|0.38|
74050642|NCT01200758|147654362|SUPERIORITY_OR_OTHER||Difference in response rates|7.66||||0.2047|TWO_SIDED|95.0|-5.0|20.3|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||20.3|-5.0|0.2047
74050643|NCT01200758|147654362|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||||TWO_SIDED|95.0|0.68|5.71||||||||5.71|0.68|
74050644|NCT01200758|147654363|SUPERIORITY_OR_OTHER||Difference in response rates|-0.49||||0.8911|TWO_SIDED|95.0|-7.7|6.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson.|||6.8|-7.7|0.8911
74050645|NCT01200758|147654363|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.56|1.65||||||||1.65|0.56|
74099012|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.00002|STANDARD_ERROR_OF_MEAN|0.00003||0.536|TWO_SIDED|95.0|-0.00004|0.00009||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to parahippocampal SUVR.||0.00009|-0.00004|.536
74099013|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.013|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to parahippocampal SUVR. Growth modeling was performed using SPSS curve estimation.||||.013
74050646|NCT01200758|147654364|SUPERIORITY_OR_OTHER||Difference in CRR|17.86||||0.0335|TWO_SIDED|95.0|0.8|35.0|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||35.0|0.8|0.0335
74050647|NCT01200758|147654364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|1.06|4.78||||||||4.78|1.06|
74050648|NCT01200758|147654365|SUPERIORITY_OR_OTHER||Difference in response rates|-6.58||||0.2331|TWO_SIDED|95.0|-17.8|4.6|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||4.6|-17.8|0.2331
74050649|NCT01200758|147654365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.44|1.22||||||||1.22|0.44|
74050650|NCT01200758|147654366|SUPERIORITY_OR_OTHER||Difference in response rates|0.49||||0.9157|TWO_SIDED|95.0|-8.8|9.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||9.8|-8.8|0.9157
74050651|NCT01200758|147654366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.51||||||||1.51|0.66|
74050652|NCT01200758|147654367|SUPERIORITY_OR_OTHER||Difference in response rates|-7.28||||0.1715|TWO_SIDED|95.0|-18.0|3.5|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||3.5|-18.0|0.1715
74050653|NCT01200758|147654367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.52|1.22||||||||1.22|0.52|
74050654|NCT01200758|147654368|SUPERIORITY_OR_OTHER||Difference in response rates|-0.18||||0.9671|TWO_SIDED|95.0|-9.2|8.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||8.8|-9.2|0.9671
74050655|NCT01200758|147654368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.6|1.64||||||||1.64|0.60|
74050656|NCT01200758|147654370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.5526|TWO_SIDED|95.0|0.64|1.26|||Wald test|||||1.26|0.64|0.5526
74050657|NCT01200758|147654372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.9115|TWO_SIDED|95.0|0.71|1.36|||Wald test|||||1.36|0.71|0.9115
74050658|NCT01200758|147654375|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|1.24|1.53||||||The ratio of observed rituximab serum was determined as AUC SC/AUC IV during Cycle 7 of induction treatment.||1.53|1.24|
74050659|NCT01200758|147654376|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.941|||||TWO_SIDED|95.0|0.872|1.015||||||||1.015|0.872|
74050660|NCT01795716|147654394|NON_INFERIORITY_OR_EQUIVALENCE|The 90%CIs of the test/reference ratios for AUC0-∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.|||||<|0.05|TWO_SIDED||||||ANOVA|||The 90% confidence intervals of the test/reference ratios for AUC0-∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.||||<0.05
74099014|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.0005|<|0.001|TWO_SIDED|95.0|0.001|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to fusiform SUVR.||0.003|0.001|<.001
74099015|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.00001|STANDARD_ERROR_OF_MEAN|0.00003||0.692|TWO_SIDED|95.0|-0.00004|0.00006||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to fusiform SUVR.||0.00006|-0.00004|.692
74099016|NCT04080544|147746896|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.0004|<|0.001|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to fusiform SUVR. Growth modeling was performed using SPSS curve estimation.||||<.001
74099017|NCT04080544|147746897|OTHER|Null-hypothesis significance testing|Slope|0.18|STANDARD_ERROR_OF_MEAN|0.18||0.331|TWO_SIDED|95.0|-0.18|0.53||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to inferior temporal gyrus cortical thickness.||0.53|-0.18|.331
74099018|NCT04080544|147746897|OTHER|Null-hypothesis significance testing|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.16||0.636|TWO_SIDED|95.0|-0.24|0.39||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education||Regression testing the relationship between temporal tau SUVR to middle temporal gyrus cortical thickness.||0.39|-0.24|.636
74099019|NCT04080544|147746897|OTHER|Null-hypothesis significance testing|Slope|0.38|STANDARD_ERROR_OF_MEAN|0.16||0.024|TWO_SIDED|95.0|0.05|0.7||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to superior temporal gyrus cortical thickness.||0.70|0.05|.024
74099020|NCT04080544|147746897|OTHER|Null-hypothesis significance testing|Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.23||0.235|TWO_SIDED|95.0|-0.73|0.18||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to parahippocampal gyrus cortical thickness.||0.18|-0.73|.235
74099021|NCT04080544|147746897|OTHER|Null-hypothesis significance testing|Slope|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.639|TWO_SIDED|95.0|-0.63|1.01||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to entorhinal gyrus cortical thickness.||1.01|-0.63|.639
74099022|NCT04080544|147746897|OTHER|Null-hypothesis significance test|Slope|0.19|STANDARD_ERROR_OF_MEAN|0.16||0.252|TWO_SIDED|95.0|-0.13|0.5||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to fusiform gyrus cortical thickness.||0.50|-0.13|.252
74099023|NCT04080544|147746898|OTHER|Null-hypothesis significance test|Slope|-233.74|STANDARD_ERROR_OF_MEAN|469.31||0.619|TWO_SIDED|95.0|-1163.28|695.79||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to hippocampal volume.||695.79|-1163.28|.619
74019112|NCT00091832|147590247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||||95.0|0.51|3.24|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.24|0.51|
74019113|NCT00091832|147590247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||||95.0|0.34|2.29|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||2.29|0.34|
74019114|NCT00091832|147590247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||||95.0|0.51|3.2|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.20|0.51|
74019115|NCT00091832|147590247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||||95.0|0.7|4.34|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.34|0.70|
74019116|NCT00091832|147590248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||||95.0|0.69|4.79|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.79|0.69|
74019117|NCT00091832|147590248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||||95.0|0.25|1.76|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.76|0.25|
74019118|NCT00091832|147590248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||||95.0|0.24|1.77|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.77|0.24|
74019119|NCT00091832|147590248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||||95.0|0.22|1.58|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.58|0.22|
74019120|NCT00091832|147590248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||||95.0|0.25|1.92|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.92|0.25|
74019121|NCT00091832|147590249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||||95.0|0.51|1.31|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.31|0.51|
74019122|NCT00091832|147590249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||||95.0|0.64|1.65|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.65|0.64|
74019123|NCT00091832|147590249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.74|0.68|
74019124|NCT00091832|147590249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.74|0.68|
74019125|NCT00091832|147590249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||||95.0|0.71|1.83|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.83|0.71|
73881399|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1394|TWO_SIDED|95.0|0.79|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.32|0.79|0.1394
73888125|NCT01746901|147309537|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.0006|TWO_SIDED|95.0|1.9|6.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.8|1.9|0.0006
74019126|NCT00091832|147590260|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.543||||||95.0|0.159|1.856|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.856|0.159|
74019127|NCT00091832|147590260|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.544||||||95.0|0.159|1.859|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.859|0.159|
74019128|NCT00091832|147590260|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.791||||||95.0|0.266|2.355|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||2.355|0.266|
74019129|NCT00091832|147590260|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||||95.0|0.389|2.963|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||2.963|0.389|
74019130|NCT00091832|147590260|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||||95.0|0.158|1.847|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.847|0.158|
74019131|NCT00091832|147590261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||||95.0|0.51|7.17|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.17|0.51|
74019132|NCT00091832|147590261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||||95.0|0.36|3.97|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.97|0.36|
74019133|NCT00091832|147590261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||||95.0|0.26|2.52|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||2.52|0.26|
74019134|NCT00091832|147590261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.05|0.5|
74019135|NCT00091832|147590261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.05|0.5|
74019136|NCT01557166|147590280|SUPERIORITY_OR_OTHER||Estimated treatment difference|-6.1||||0.015||95.0|-11.0|-1.19|||ANCOVA|ANCOVA model was used with treatment, country and sex as fixed factors, and the baseline value of AHI, baseline BMI and baseline age as covariates.||Let μ liraglutide 3.0mg and μ placebo denote mean change in AHI for liraglutide 3.0 mg and placebo,respectively. The null-hypothesis and the alternative was H0: μliraglutide 3.0mg = μplacebo against the alternative HA: μliraglutide 3.0mg ≠ μplacebo.||-1.19|-11.0|0.015
74050661|NCT03525613|147654395|SUPERIORITY||LS Mean Difference|-0.4114||||0.0004|TWO_SIDED|95.0|-0.6397|-0.1831|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||-0.1831|-0.6397|0.0004
74050662|NCT03525613|147654395|SUPERIORITY||LS Mean Difference|-0.318||||0.0055|TWO_SIDED|95.0|-0.5423|-0.0937|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||-0.0937|-0.5423|0.0055
74050663|NCT03525613|147654396|SUPERIORITY||LS Mean Difference|-0.9015|||<|0.0001|TWO_SIDED|95.0|-1.3026|-0.5004|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.5004|-1.3026|<0.0001
74050664|NCT03525613|147654396|SUPERIORITY||LS Mean Difference|-0.7426||||0.0002|TWO_SIDED|95.0|-1.1282|-0.357|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.3570|-1.1282|0.0002
74019137|NCT00874250|147590290|SUPERIORITY_OR_OTHER||Proportion|0.98||||0.0024|TWO_SIDED|95.0|0.895|0.996|||Binomial Test|||||0.996|0.895|0.0024
74019138|NCT00428597|147590370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.418||||0.000118|TWO_SIDED|95.0|0.263|0.662||Log-rank test statistic and 2-sided p-value from the unstratified log-rank test|Log Rank||Hazard ratio based on the Cox Proportional hazards model|||0.662|0.263|0.000118
74019139|NCT00428597|147590371|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|9.3|||||TWO_SIDED|95.0|4.1|17.5|||||Confidence interval (CI) using exact method based on binomial distribution.|||17.5|4.1|
74019140|NCT00428597|147590374|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.409||||0.0204|TWO_SIDED|95.0|0.187|0.894||2-sided p-value from the unstratified log-rank test.|Log Rank||Hazard ratio based on the Cox Proportional hazards model.|||0.894|0.187|0.0204
74099024|NCT04080544|147746899|OTHER|Null-hypothesis significance test|Slope|9260.01|STANDARD_ERROR_OF_MEAN|3836.92||0.017|TWO_SIDED|95.0|1660.52|16859.51||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to volume of white matter hypointensities.||16859.51|1660.52|.017
74099025|NCT04080544|147746900|OTHER|Null-hypothesis significance test|Slope|0.29|STANDARD_ERROR_OF_MEAN|0.35||0.411|TWO_SIDED|95.0|-0.41|0.99||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to activation of inferior frontal gyrus (beta) on the semantic judgment fMRI task.||0.99|-0.41|.411
74050665|NCT03525613|147654397|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2234||||0.0007|TWO_SIDED|95.0|-0.3522|-0.0946|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0946|-0.3522|0.0007
74050666|NCT03525613|147654397|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1618||||0.0116|TWO_SIDED|95.0|-0.2874|-0.0361|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0361|-0.2874|0.0116
74050667|NCT03525613|147654397|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1862||||0.0181|TWO_SIDED|95.0|-0.3406|-0.0318|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0318|-0.3406|0.0181
74050668|NCT03525613|147654397|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1526||||0.0467|TWO_SIDED|95.0|-0.303|-0.0023|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0023|-0.3030|0.0467
74050669|NCT03525613|147654397|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2265||||0.0019|TWO_SIDED|95.0|-0.3696|-0.0834|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0834|-0.3696|0.0019
74050670|NCT03525613|147654397|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1586||||0.0288|TWO_SIDED|95.0|-0.3009|-0.0164|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0164|-0.3009|0.0288
74050671|NCT03525613|147654397|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2341||||0.008|TWO_SIDED|95.0|-0.4071|-0.0611|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0611|-0.4071|0.0080
74099026|NCT04080544|147746900|OTHER|Null-hypothesis significance test|Slope|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.412|TWO_SIDED|95.0|-0.34|0.81||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to middle temporal gyrus activation (beta) on the semantic judgment fMRI task.||0.81|-0.34|.412
74099027|NCT04080544|147746900|OTHER|Null-hypothesis significance test|Slope|0.31|STANDARD_ERROR_OF_MEAN|0.4||0.438|TWO_SIDED|95.0|-0.48|1.09||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to precuneus gyrus activation (beta) on the semantic judgment fMRI task.||1.09|-0.48|.438
74099028|NCT04080544|147746901|OTHER|Null-hypothesis significance test|Slope|-1.13|STANDARD_ERROR_OF_MEAN|0.5||0.026|TWO_SIDED|95.0|-2.12|-0.14||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to resting-state system segregation.||-0.14|-2.12|.026
74099029|NCT00213135|147746999|SUPERIORITY_OR_OTHER||Relative Risk|0.43|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.35|0.54|||Wald Chi-square test|||||0.54|0.35|<0.001
74099030|NCT00213135|147746999|SUPERIORITY_OR_OTHER||Relative Risk|0.43|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.34|0.54|||Wald Chi-square test|||||0.54|0.34|<0.001
73881400|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0522|TWO_SIDED|95.0|0.99|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.36|0.99|0.0522
74099031|NCT01328379|147747003|SUPERIORITY_OR_OTHER||least squares mean|0.054|STANDARD_ERROR_OF_MEAN|0.0724||0.457|TWO_SIDED|95.0|-0.088|0.196||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.196|-0.088|0.457
74019141|NCT00428597|147590375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1543||||0.6799|TWO_SIDED|95.0|-4.3|6.6||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||6.6|-4.3|0.6799
74099032|NCT01328379|147747003|SUPERIORITY_OR_OTHER||least squares mean|0.118|STANDARD_ERROR_OF_MEAN|0.0732||0.107|TWO_SIDED|95.0|-0.026|0.262|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.262|-0.026|0.107
74099033|NCT01328379|147747003|SUPERIORITY_OR_OTHER||least squares mean|0.064|STANDARD_ERROR_OF_MEAN|0.0724||0.375|TWO_SIDED|95.0|-0.078|0.207|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.207|-0.078|0.375
74099034|NCT01328379|147747004|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.014|STANDARD_ERROR_OF_MEAN|0.0666||0.832|TWO_SIDED|95.0|-0.145|0.117||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.117|-0.145|0.832
74099035|NCT01328379|147747004|SUPERIORITY_OR_OTHER||Least Squares Mean|0.093|STANDARD_ERROR_OF_MEAN|0.0674||0.167|TWO_SIDED|95.0|-0.039|0.226|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.226|-0.039|0.167
74050672|NCT03525613|147654397|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2459||||0.0007|TWO_SIDED|95.0|-0.3886|-0.1031|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1031|-0.3886|0.0007
74050673|NCT03525613|147654397|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.8702|||<|0.0001|TWO_SIDED|95.0|-1.274|-0.4664|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.4664|-1.2740|<0.0001
74050674|NCT03525613|147654397|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.7189||||0.0003|TWO_SIDED|95.0|-1.1039|-0.3339|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.3339|-1.1039|0.0003
74099036|NCT01328379|147747004|SUPERIORITY_OR_OTHER||Least Squares Mean|0.107|STANDARD_ERROR_OF_MEAN|0.0666||0.108|TWO_SIDED|95.0|-0.024|0.238|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.238|-0.024|0.108
74099037|NCT01328379|147747005|SUPERIORITY_OR_OTHER||Lease Squares Mean|-0.4|STANDARD_ERROR_OF_MEAN|2.367||0.866|TWO_SIDED|95.0|-5.05|4.25|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3||4.25|-5.05|0.866
74050675|NCT00461552|147654402|SUPERIORITY|||||||0.84||||||Treatment time month interaction|Mixed Models Analysis|||||||0.84
74050676|NCT00461552|147654403|OTHER|||||||0.4||||||Treatment time month interaction|Mixed Models Analysis|||||||0.4
74050677|NCT01202643|147654459|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||ANCOVA|||||||0.67
74050678|NCT01202643|147654460|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared, Corrected|||Study was closed due to insufficient recruitment||||0.74
74050679|NCT03198884|147654461|OTHER|The percent of patients with an RNA \<50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure. Change in mean serum creatinine from baseline was analyzed using Wilcoxon signed rank test.|||||<|0.05|||||||McNemar||||Change in mean CD4+ cell counts from baseline was analyzed using a paired t-test. All analyses used a p-value of less than or equal to 0.05 as significant. Statistical analyses were performed using R software, version 3.4.3.|||<0.05
74050680|NCT03198884|147654462|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74050681|NCT03049852|147654468|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74050682|NCT03049852|147654470|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.007|TWO_SIDED||||||ANOVA|||||||0.007
74050683|NCT00537810|147654506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Chi-squared|df=3||Post-treatment||||0.60
74050684|NCT00537810|147654506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Chi-squared|df=3||6 month follow up||||0.13
74050685|NCT00537810|147654506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|df=3||12 month follow up||||0.29
74050686|NCT01711359|147654560|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority is concluded if the lower bound of the 95% CI for the difference in response rate is \>-12%|Newcombe-Wilson method|14.8|||||TWO_SIDED|95.0|5.5|24.1|||||Estimation Parameter: Newcombe-Wilson method without continuity correction for difference in the response rate (Baricitinib minus Methotrexate).|||24.1|5.5|
74050687|NCT01385098|147654582|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
74099038|NCT01328379|147747005|SUPERIORITY_OR_OTHER||Least Squares Mean|-2.56|STANDARD_ERROR_OF_MEAN|2.393||0.286|TWO_SIDED|95.0|-7.26|2.15|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3||2.15|-7.26|0.286
74099039|NCT01328379|147747005|SUPERIORITY_OR_OTHER||Least Squares Mean|-2.16|STANDARD_ERROR_OF_MEAN|2.366||0.362|TWO_SIDED|95.0|-6.81|2.49|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 3||2.49|-6.81|0.362
74099040|NCT01328379|147747006|SUPERIORITY_OR_OTHER||Least Squares Mean|0.84|STANDARD_ERROR_OF_MEAN|2.237||0.708|TWO_SIDED|95.0|-3.56|5.24|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2||5.24|-3.56|0.708
74050688|NCT01385098|147654583|SUPERIORITY_OR_OTHER|||||||0.013||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)|||||||0.013
74050689|NCT01385098|147654583|SUPERIORITY_OR_OTHER|||||||0.01||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)|||||||0.010
74050690|NCT02698176|147654590|OTHER||Estimation of DLT Rate|0.25|||||TWO_SIDED|80.0|0.121|0.418|||||Point estimate and 2-sided 80% Bayesian credible interval for DLT rate estimated for the total number of participants from all 3 cohorts (CRPC+NMC+TNBC) that were evaluable for DLT analysis based on a non-informative prior distribution of Beta (1,1).|||0.418|0.121|
74050691|NCT02253173|147654609|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050692|NCT02253173|147654609|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050693|NCT02253173|147654609|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050694|NCT02253173|147654610|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050695|NCT02253173|147654610|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050696|NCT02253173|147654610|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050697|NCT02253173|147654611|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050698|NCT02253173|147654611|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050699|NCT02253173|147654611|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050700|NCT02253173|147654612|SUPERIORITY_OR_OTHER|||||||0.0149|||||||Mixed Models Analysis|||||||0.0149
74050701|NCT02253173|147654612|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050702|NCT02253173|147654612|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050703|NCT02253173|147654613|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050704|NCT02253173|147654613|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050705|NCT02253173|147654613|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050706|NCT02253173|147654614|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050707|NCT02253173|147654614|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050708|NCT02253173|147654614|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050709|NCT02253173|147654615|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050710|NCT02253173|147654615|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050711|NCT02253173|147654615|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050712|NCT02253173|147654616|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050713|NCT02253173|147654616|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050714|NCT02253173|147654616|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050715|NCT02253173|147654617|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050716|NCT02253173|147654617|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050717|NCT02253173|147654617|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050718|NCT02253173|147654618|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050719|NCT02253173|147654618|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050720|NCT02253173|147654618|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050721|NCT02253173|147654619|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050722|NCT02253173|147654619|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050723|NCT02253173|147654619|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050724|NCT02253173|147654620|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050725|NCT02253173|147654620|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050726|NCT02253173|147654620|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050727|NCT02253173|147654621|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050728|NCT02253173|147654621|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050729|NCT02253173|147654621|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050730|NCT02253173|147654622|SUPERIORITY_OR_OTHER|||||||0.026|||||||Mixed Models Analysis|||||||0.0260
74050731|NCT02253173|147654622|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Mixed Models Analysis|||||||0.0019
74099041|NCT01328379|147747006|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.38|STANDARD_ERROR_OF_MEAN|2.258||0.868|TWO_SIDED|95.0|-4.81|4.06|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2||4.06|-4.81|0.868
74099042|NCT01328379|147747006|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.21|STANDARD_ERROR_OF_MEAN|2.236||0.588|TWO_SIDED|95.0|-5.61|3.18|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 2||3.18|-5.61|0.588
74050732|NCT02253173|147654622|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Mixed Models Analysis|||||||0.0105
74050733|NCT02253173|147654623|SUPERIORITY_OR_OTHER|||||||0.0069|||||||Mixed Models Analysis|||||||0.0069
74050734|NCT02253173|147654623|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Mixed Models Analysis|||||||0.0009
74050735|NCT02253173|147654623|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050736|NCT02253173|147654624|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
74050737|NCT02253173|147654624|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050738|NCT02253173|147654624|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050739|NCT02253173|147654625|SUPERIORITY_OR_OTHER|||||||0.1269|||||||Mixed Models Analysis|||||||0.1269
74050740|NCT02253173|147654625|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Mixed Models Analysis|||||||0.0019
74050741|NCT02253173|147654625|SUPERIORITY_OR_OTHER|||||||0.0082|||||||Mixed Models Analysis|||||||0.0082
74050742|NCT02253173|147654626|SUPERIORITY_OR_OTHER|||||||0.0094|||||||Mixed Models Analysis|||||||0.0094
74050743|NCT02253173|147654626|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
74050744|NCT02253173|147654626|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
74050745|NCT02253173|147654627|SUPERIORITY_OR_OTHER|||||||0.0128|||||||Mixed Models Analysis|||||||0.0128
74050746|NCT02253173|147654627|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050747|NCT02253173|147654627|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Mixed Models Analysis|||||||0.0008
74050748|NCT02253173|147654628|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
74050749|NCT02253173|147654628|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
73888126|NCT01746901|147309537|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8765|TWO_SIDED|95.0|-2.7|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-2.7|0.8765
74050750|NCT02253173|147654628|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050751|NCT02253173|147654629|SUPERIORITY_OR_OTHER|||||||0.9616|||||||Mixed Models Analysis|||||||0.9616
74050752|NCT02253173|147654629|SUPERIORITY_OR_OTHER|||||||0.2439|||||||Mixed Models Analysis|||||||0.2439
74050753|NCT02253173|147654629|SUPERIORITY_OR_OTHER|||||||0.6518|||||||Mixed Models Analysis|||||||0.6518
74050754|NCT02253173|147654630|SUPERIORITY_OR_OTHER|||||||0.7829|||||||Mixed Models Analysis|||||||0.7829
74050755|NCT02253173|147654630|SUPERIORITY_OR_OTHER|||||||0.2328|||||||Mixed Models Analysis|||||||0.2328
74050756|NCT02253173|147654630|SUPERIORITY_OR_OTHER|||||||0.4118|||||||Mixed Models Analysis|||||||0.4118
74050757|NCT02253173|147654631|SUPERIORITY_OR_OTHER|||||||0.0639|||||||Mixed Models Analysis|||||||0.0639
74050758|NCT02253173|147654631|SUPERIORITY_OR_OTHER|||||||0.0356|||||||Mixed Models Analysis|||||||0.0356
74050759|NCT02253173|147654631|SUPERIORITY_OR_OTHER|||||||0.0914|||||||Mixed Models Analysis|||||||0.0914
74050760|NCT02253173|147654632|SUPERIORITY_OR_OTHER|||||||0.0503|||||||Mixed Models Analysis|||||||0.0503
74050761|NCT02253173|147654632|SUPERIORITY_OR_OTHER|||||||0.0055|||||||Mixed Models Analysis|||||||0.0055
74050762|NCT02253173|147654632|SUPERIORITY_OR_OTHER|||||||0.0263|||||||Mixed Models Analysis|||||||0.0263
74050763|NCT02253173|147654633|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050764|NCT02253173|147654633|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050765|NCT02253173|147654633|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050766|NCT02253173|147654634|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050767|NCT02253173|147654634|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050768|NCT02253173|147654634|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050769|NCT02253173|147654635|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050770|NCT02253173|147654635|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050771|NCT02253173|147654635|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050772|NCT02253173|147654636|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050773|NCT02253173|147654636|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050774|NCT02253173|147654636|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050775|NCT02253173|147654637|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050776|NCT02253173|147654637|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050777|NCT02253173|147654637|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050778|NCT02253173|147654638|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050779|NCT02253173|147654638|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050780|NCT02253173|147654638|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050781|NCT02253173|147654639|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050782|NCT02253173|147654639|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050783|NCT02253173|147654639|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050784|NCT02253173|147654640|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050785|NCT02253173|147654640|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050786|NCT02253173|147654640|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050787|NCT02253173|147654641|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050788|NCT02253173|147654641|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050789|NCT02253173|147654641|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050790|NCT02253173|147654642|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050791|NCT02253173|147654642|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050792|NCT02253173|147654642|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050793|NCT02253173|147654643|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050794|NCT02253173|147654643|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74099043|NCT01328379|147747007|SUPERIORITY_OR_OTHER||Least Squares Mean|35.4|STANDARD_ERROR_OF_MEAN|34.57||0.308|TWO_SIDED|95.0|-33.0|103.7|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||103.7|-33.0|0.308
73881401|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.97||||0.0119|TWO_SIDED|95.0|1.63|11.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.61|1.63|0.0119
73881402|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1474|TWO_SIDED|95.0|0.77|5.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.53|0.77|0.1474
74050795|NCT02253173|147654643|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050796|NCT02253173|147654644|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050797|NCT02253173|147654644|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74099044|NCT01328379|147747007|SUPERIORITY_OR_OTHER||Least Squares Mean|87.1|STANDARD_ERROR_OF_MEAN|34.9||0.014|TWO_SIDED|95.0|18.2|156.1|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||156.1|18.2|0.014
74099045|NCT01328379|147747007|SUPERIORITY_OR_OTHER||Least Squares Mean|51.7|STANDARD_ERROR_OF_MEAN|34.21||0.133|TWO_SIDED|95.0|-15.9|119.3|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||119.3|-15.9|0.133
74099046|NCT01328379|147747008|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.32|TWO_SIDED|95.0|0.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.1|-0.0|0.320
74099047|NCT01328379|147747008|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.734|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.0|-0.1|0.734
73881403|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|5.08||||0.0026|TWO_SIDED|95.0|1.76|14.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.67|1.76|0.0026
74050798|NCT02253173|147654644|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050799|NCT02253173|147654645|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mixed Models Analysis|||||||0.0004
74050800|NCT02253173|147654645|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050801|NCT02253173|147654645|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050802|NCT02253173|147654646|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
74050803|NCT02253173|147654646|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050804|NCT02253173|147654646|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050805|NCT02253173|147654647|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050806|NCT02253173|147654647|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050807|NCT02253173|147654647|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050808|NCT02253173|147654648|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74099048|NCT01328379|147747008|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.185|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.0|-0.1|0.185
74099049|NCT01328379|147747009|SUPERIORITY_OR_OTHER||Least Squares Mean|-3.4|STANDARD_ERROR_OF_MEAN|1.79||0.055|TWO_SIDED|95.0|-7.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3||0.1|-7.0|0.055
74099050|NCT01328379|147747009|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.2|STANDARD_ERROR_OF_MEAN|1.83||0.53|TWO_SIDED|95.0|-4.7|2.4|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3||2.4|-4.7|0.530
74099051|NCT01328379|147747009|SUPERIORITY_OR_OTHER||Least Squares Mean|2.3|STANDARD_ERROR_OF_MEAN|1.8||0.203|TWO_SIDED|95.0|-1.2|5.8|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in EQ-5D VAS score at Visit 3||5.8|-1.2|0.203
74050809|NCT02253173|147654648|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74050810|NCT02253173|147654648|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
74099052|NCT00660907|147747010|NON_INFERIORITY_OR_EQUIVALENCE|non-inferior margin delta = 0.35|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0569|<|0.0001|TWO_SIDED|95.0|-0.11|0.11||Significant at alpha=0.025 (1-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||The null hypothesis is given as H0: mean(treat) minus mean(reference) \>= delta versus the alternative HA: mean(treat) minus mean(reference) \< delta (with alpha = 0.025, one-sided)||0.11|-0.11|<0.0001
74050811|NCT02253173|147654649|SUPERIORITY_OR_OTHER|||||||0.9075|||||||ANCOVA|||||||0.9075
74050812|NCT02253173|147654649|SUPERIORITY_OR_OTHER|||||||0.0492|||||||ANCOVA|||||||0.0492
74050813|NCT02253173|147654649|SUPERIORITY_OR_OTHER|||||||0.0019|||||||ANCOVA|||||||0.0019
74050814|NCT02253173|147654650|SUPERIORITY_OR_OTHER|||||||0.9719|||||||ANCOVA|||||||0.9719
74050815|NCT02253173|147654650|SUPERIORITY_OR_OTHER|||||||0.0614|||||||ANCOVA|||||||0.0614
74050816|NCT02253173|147654650|SUPERIORITY_OR_OTHER|||||||0.0085|||||||ANCOVA|||||||0.0085
74050817|NCT02253173|147654651|SUPERIORITY_OR_OTHER|||||||0.9999|||||||ANCOVA|||||||0.9999
74050818|NCT02253173|147654651|SUPERIORITY_OR_OTHER|||||||0.2855|||||||ANCOVA|||||||0.2855
74050819|NCT02253173|147654651|SUPERIORITY_OR_OTHER|||||||0.1189|||||||ANCOVA|||||||0.1189
74099053|NCT00660907|147747011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.65|STANDARD_ERROR_OF_MEAN|0.2483|<|0.0001|TWO_SIDED|95.0|-5.14|-4.17||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(reference) = 0 versus the alternative HA: mean(treat) minus mean(reference) =/= 0||-4.17|-5.14|<0.0001
74050820|NCT02253173|147654652|SUPERIORITY_OR_OTHER|||||||0.4162|||||||ANCOVA|||||||0.4162
74050821|NCT02253173|147654652|SUPERIORITY_OR_OTHER|||||||0.0013|||||||ANCOVA|||||||0.0013
74050822|NCT02253173|147654652|SUPERIORITY_OR_OTHER|||||||0.0003|||||||ANCOVA|||||||0.0003
74050823|NCT02253173|147654653|SUPERIORITY_OR_OTHER|||||||0.9929|||||||ANCOVA|||||||0.9929
74050824|NCT02253173|147654653|SUPERIORITY_OR_OTHER|||||||0.9634|||||||ANCOVA|||||||0.9634
74050825|NCT02253173|147654653|SUPERIORITY_OR_OTHER|||||||0.0898|||||||ANCOVA|||||||0.0898
74050826|NCT02253173|147654654|SUPERIORITY_OR_OTHER|||||||0.5146|||||||ANCOVA|||||||0.5146
74050827|NCT02253173|147654654|SUPERIORITY_OR_OTHER|||||||0.0099|||||||ANCOVA|||||||0.0099
74050828|NCT02253173|147654654|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.0150
74050829|NCT02253173|147654655|SUPERIORITY_OR_OTHER|||||||0.9039|||||||ANCOVA|||||||0.9039
74050830|NCT02253173|147654655|SUPERIORITY_OR_OTHER|||||||0.3751|||||||ANCOVA|||||||0.3751
74050831|NCT02253173|147654655|SUPERIORITY_OR_OTHER|||||||0.0073|||||||ANCOVA|||||||0.0073
74050832|NCT00410514|147654657|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.4|||||TWO_SIDED|95.0|-0.63|1.42|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||1.42|-0.63|
74050833|NCT00410514|147654657|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.62|||||TWO_SIDED|95.0|-0.43|1.68|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||1.68|-0.43|
74050834|NCT00410514|147654659|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-5.94|||||TWO_SIDED|95.0|-13.98|2.09|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||2.09|-13.98|
74099054|NCT00660907|147747012|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-37.2|STANDARD_ERROR_OF_MEAN|2.578|<|0.0001|TWO_SIDED|95.0|-42.3|-32.2||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0||-32.2|-42.3|<0.0001
74050835|NCT00410514|147654659|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-1.39|||||TWO_SIDED|95.0|-9.73|6.96|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||6.96|-9.73|
74050836|NCT02985684|147654691|OTHER|Acceptable performance: favorably exclude PG=0.88 with 95% confidence. Expected 6-month closure success proportion = 0.98. Acceptable performance margin = 0.10. PG = 0.98 - 0.10 = 0.88.|Binomial proportion|1.0|||<|0.0001|ONE_SIDED|95.0|0.974|||A priori 1-sided alpha = 0.05. If test rejects H0, then test primary outcome 2 (clinical success) at 1-sided alpha = 0.05; otherwise testing stops with failure to reject both primary outcome null hypotheses.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month closure success compared to a performance goal (PG).~H0: P ≤ 0.88 vs H1: P \> 0.88, where P is the true proportion of subjects with 6-month closure success and 0.88 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=103 subjects provide ≥95% power to exclude PG with 95% confidence if P=0.98 under H1."|||0.974|<0.0001
74050837|NCT02985684|147654692|OTHER|Acceptable performance: favorably exclude PG=0.76 with 95% confidence. Expected 6-month clinical success proportion = 0.88. Acceptable performance margin = 0.12. PG = 0.88 - 0.12 = 0.76.|Binomial proportion|0.9|||<|0.0001|ONE_SIDED|95.0|0.843|||A priori 1-sided alpha = 0.05. If test of primary outcome 1 rejects H0, then test at 1-sided alpha = 0.05; otherwise no testing of this primary outcome and failure to reject null hypothesis.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month clinical success compared to a performance goal (PG).~H0: P ≤ 0.76 vs H1: P \> 0.76, where P is the true proportion of subjects with 6-month clinical success and 0.76 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=112 subjects provide 95% power to exclude PG with 95% confidence if P=0.88 under H1."|||0.843|<0.0001
74050838|NCT01928186|147654742|OTHER|||||||0.51|||||||Fisher Exact|the mid-P adjustment to Fisher's exact test||Association between response assessed by Ki-67 protein staining (i.e. \< 10% positive cells in the surgical sample) and by the influx constant Ki decline (i.e. 30 % or larger decline between the baseline and post-therapy FLT PET) was analyzed using the mid-P adjustment to Fisher's exact test.||||0.51
74050839|NCT04540627|147654756|SUPERIORITY|||||||0.5802|||||||Wilcoxon (Mann-Whitney)|||||||0.5802
74050840|NCT04540627|147654757|SUPERIORITY|||||||0.4868|||||||Wilcoxon (Mann-Whitney)|||||||0.4868
74050841|NCT04540627|147654758|SUPERIORITY|||||||0.2681|||||||Wilcoxon (Mann-Whitney)|||||||0.2681
74050842|NCT04540627|147654759|SUPERIORITY|||||||0.2431|||||||Wilcoxon (Mann-Whitney)|||||||0.2431
74050843|NCT04540627|147654764|SUPERIORITY|||||||0.4868|||||||Wilcoxon (Mann-Whitney)|||||||0.4868
74050844|NCT04540627|147654766|SUPERIORITY|||||||0.0403|||||||Wilcoxon (Mann-Whitney)|||||||0.0403
74050845|NCT01265719|147654784|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.2||0.1126|TWO_SIDED|95.0|-0.09|0.74|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|\<5 years||0.74|-0.09|0.1126
74050846|NCT01265719|147654784|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.484|TWO_SIDED|95.0|-0.12|0.06|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|5 to \<18 years||0.06|-0.12|0.4840
74050847|NCT01265719|147654786|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.3||0.902|TWO_SIDED|95.0|-0.63|0.56|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|\<5 years||0.56|-0.63|0.9020
74099055|NCT00660907|147747013|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.8|STANDARD_ERROR_OF_MEAN|2.48|<|0.0001|TWO_SIDED|95.0|26.0|35.7||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0||35.7|26.0|<0.0001
73881404|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1263|TWO_SIDED|95.0|0.81|5.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.51|0.81|0.1263
74050848|NCT01265719|147654786|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.2||0.8826|TWO_SIDED|95.0|-0.37|0.43|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|5 to \<18 years||0.43|-0.37|0.8826
74050849|NCT01265719|147654787|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.62|STANDARD_ERROR_OF_MEAN|1.25||0.2003|TWO_SIDED|95.0|-4.13|0.89|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|\<5 years||0.89|-4.13|0.2003
74050850|NCT01265719|147654787|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.75||0.894|TWO_SIDED|95.0|-1.59|1.39|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to \<18 years (IOP \<21mmHg at Baseline)||1.39|-1.59|0.8940
74099056|NCT00618332|147747047|SUPERIORITY_OR_OTHER|||||||0.372||95.0|||||t-test, 2 sided|||||||0.372
74099057|NCT00618332|147747048|SUPERIORITY_OR_OTHER|||||||0.775||95.0|||||t-test, 2 sided|||||||0.775
74099058|NCT00618332|147747049|SUPERIORITY_OR_OTHER|||||||0.737||95.0|||||t-test, 2 sided|||||||0.737
74050851|NCT01265719|147654787|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-6.66|STANDARD_ERROR_OF_MEAN|2.41||0.0184|TWO_SIDED|95.0|-11.95|-1.36|||ANCOVA|The results were interpreted with caution because of the very small sample size of non-PG treatment group (n=4).|Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to \<18 years (IOP ≥21mmHg at Baseline)||-1.36|-11.95|0.0184
74050852|NCT01265719|147654788|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.0|||>|0.999|TWO_SIDED|95.0|-13.97|15.9|||Fisher Exact|||||15.90|-13.97|>0.999
74050853|NCT01265719|147654789|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.4|||>|0.999|TWO_SIDED|95.0|-15.32|14.55|||Fisher Exact|||||14.55|-15.32|>0.999
74050854|NCT01265719|147654790|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.2|||>|0.999|TWO_SIDED|95.0|-13.78|16.09|||Fisher Exact|||||16.09|-13.78|>0.999
74050855|NCT01265719|147654792|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.6||||0.6414|TWO_SIDED|95.0|-13.39|16.48|||Fisher Exact|||||16.48|-13.39|0.6414
74050856|NCT01265719|147654793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.52||0.2437|TWO_SIDED|95.0|-0.43|1.65|||ANCOVA||Change from baseline to last available observation in longest lash length (LLL) was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|\<5 years||1.65|-0.43|0.2437
74050857|NCT01265719|147654793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.32||0.5199|TWO_SIDED|95.0|-0.85|0.43|||ANCOVA||Change from baseline to last available observation in LLL was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|5 to \<18 years||0.43|-0.85|0.5199
74050858|NCT01265719|147654794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.68|STANDARD_ERROR_OF_MEAN|15.54||0.8643|TWO_SIDED|95.0|-34.3|28.94|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|\<5 years||28.94|-34.30|0.8643
74050859|NCT01265719|147654794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.87|STANDARD_ERROR_OF_MEAN|4.87||0.8591|TWO_SIDED|95.0|-10.54|8.8|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|5 to \<18 years||8.80|-10.54|0.8591
74050860|NCT01265719|147654795|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.5||||0.2413|TWO_SIDED|95.0|-10.49|19.36|||Fisher Exact|||||19.36|-10.49|0.2413
74050861|NCT05466240|147654807|EQUIVALENCE|For each post-baseline collection time point, treatment difference and p-value comparing the mean change in viral load from baseline between treatment arms from an analysis of covariance model with covariate baseline viral load.|||||<|0.95|||||||ANCOVA|||||||<0.95
74050862|NCT03474380|147654844|SUPERIORITY|A generalized linear mixed model (GLMM) with a negative binomial distribution and a log link was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods) and site. The final model was adjusted for Veteran characteristics, including age, gender, race, marital status, service connection, rural status, and chronic disease burden concurrence score (Nosos).|rate ratio (RR)|0.58||||0.091|TWO_SIDED|95.0|0.31|1.09|||generalized linear mixed model (GLMM)||Rate ratio, rate of days not in the community in 6 month intervals in intervention versus usual care.|Days not at home in 6 month intervals.||1.09|0.31|0.091
74050863|NCT03474380|147654845|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||0.8|-0.7|0.98
74050864|NCT03474380|147654846|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|0.4||||0.167|TWO_SIDED|95.0|-0.2|1.0|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||1.0|-0.2|0.167
74050865|NCT03474380|147654847|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|-0.5||||0.122|TWO_SIDED|95.0|-1.0|0.1|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||0.1|-1.0|0.122
74050866|NCT00945945|147654848|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34||||0.105|TWO_SIDED|95.0|-0.07|0.75||P-value for Change from Baseline to Endpoint (BOCF).|ANCOVA|Main Effect Model: Change = Treatment + Pooled Investigator + Baseline (Type III sums of squares).|Least Squares Mean Difference = DLX30-PLA minus PLA-DLX60.|||0.75|-0.07|0.105
73888127|NCT01746901|147309537|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.4746|TWO_SIDED|95.0|-1.6|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|-1.6|0.4746
74050867|NCT00805194|147654870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0019|TWO_SIDED|95.0|0.68|0.92|||Regression, Cox||Hazard Ratio (HR) below 1 favors nintedanib|HR, Confidence Interval (CI) and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||0.92|0.68|0.0019
74099059|NCT00618332|147747050|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||t-test, 2 sided|||||||0.117
74099060|NCT00618332|147747051|SUPERIORITY_OR_OTHER|||||||0.676||95.0|||||t-test, 2 sided|||||||0.676
74099061|NCT00618332|147747052|SUPERIORITY_OR_OTHER|||||||0.795||95.0|||||t-test, 2 sided|||||||0.795
74099062|NCT00618332|147747053|SUPERIORITY_OR_OTHER|||||||0.638||95.0|||||t-test, 2 sided|||||||0.638
74099063|NCT00618332|147747054|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||||||0.800
74099064|NCT00618332|147747055|SUPERIORITY_OR_OTHER|||||||0.968||95.0|||||t-test, 2 sided|||||||0.968
74099065|NCT05773794|147747066|SUPERIORITY|||||||0.968|||||||t-test, 2 sided|||||||0.968
74099066|NCT05773794|147747066|SUPERIORITY|||||||0.366|||||||t-test, 2 sided|||||||0.366
74050868|NCT00805194|147654871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0073|TWO_SIDED|95.0|0.6|0.92||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma and \<9 months since start of first line therapy."||0.92|0.60|0.0073
74099067|NCT05773794|147747066|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
74099068|NCT05773794|147747067|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||||||0.016
74099069|NCT05773794|147747067|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
74099070|NCT05773794|147747067|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
74099071|NCT05773794|147747068|SUPERIORITY|||||||0.0196|||||||t-test, 2 sided|||||||0.0196
74099072|NCT05773794|147747068|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
74099073|NCT05773794|147747068|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
74099074|NCT01917916|147747080|OTHER||Slope|2.4386|STANDARD_ERROR_OF_MEAN|0.3417|||TWO_SIDED|95.0|1.7504|3.1267|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter Cmax, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.1267|1.7504|
74099075|NCT01917916|147747081|OTHER||Slope|2.6033|STANDARD_ERROR_OF_MEAN|0.2499|||TWO_SIDED|95.0|2.0993|3.1073|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter AUC0-∞, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.1073|2.0993|
74099076|NCT01917916|147747082|OTHER||Slope|3.1291|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|95.0|2.3395|3.9187|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter AUC0-tz, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.9187|2.3395|
74099077|NCT02618759|147747103|SUPERIORITY|||||||0.0745|||||||Cochran-Mantel-Haenszel|||||||0.0745
74099078|NCT02618759|147747104|SUPERIORITY|||||||0.231|||||||Cochran-Mantel-Haenszel|||||||0.2310
74099079|NCT02618759|147747105|SUPERIORITY|||||||0.1059|||||||Cochran-Mantel-Haenszel|||||||0.1059
74099080|NCT02618759|147747106|SUPERIORITY|||||||0.6962|||||||Cochran-Mantel-Haenszel|||||||0.6962
74099081|NCT02618759|147747107|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
74099082|NCT02618759|147747108|SUPERIORITY|||||||0.1044|||||||Cochran-Mantel-Haenszel|||||||0.1044
74099083|NCT02500043|147747112|OTHER||Hazard Ratio (HR)|0.6917||||0.0003|TWO_SIDED|95.0|0.5597|0.8548||One-sided P-Value.|Log Rank|||TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified Cox's proportional hazard (CPH) model and survival was summarized using Kaplan Meier estimates.||0.8548|0.5597|0.0003
74099084|NCT02500043|147747113|OTHER||Hazard Ratio (HR)|0.5723|||||TWO_SIDED|95.0|0.4674|0.7008||||||TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified CPH model and survival was summarized using Kaplan Meier estimates.||0.7008|0.4674|
74099085|NCT02932306|147747122|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
74099086|NCT02932306|147747123|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
74099087|NCT02932306|147747124|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth's Penalized Likelihood) with factors of treatment group and analysis center.||||<0.001
74050869|NCT00805194|147654871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0359|TWO_SIDED|95.0|0.7|0.99||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma."||0.99|0.70|0.0359
74099088|NCT00605540|147747150|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||All data were analyzed using SigmaStat 3.2 (Inc., USA) software. Mean ± SD or median interquartile range (25-75%) was used depending on the data distribution. Wilcoxon test was applied to compare the characteristics at baseline to those observed after 3 years.||||0.09
74099089|NCT00843479|147747155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74099090|NCT00843479|147747156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
74099091|NCT00843479|147747157|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
74099092|NCT00843479|147747158|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
74099093|NCT00843479|147747159|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
73888128|NCT01746901|147309537|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.4607|TWO_SIDED|95.0|-3.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-3.3|0.4607
74099094|NCT00843479|147747160|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
74099095|NCT01544179|147747161|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.273|TWO_SIDED|95.0|0.65|1.13|||Cox Proportional Hazards|||||1.13|0.65|0.273
74099096|NCT01544179|147747164|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.62||||0.029|TWO_SIDED|95.0|1.05|2.52|||Cox Proportional Hazards|||||2.52|1.05|0.029
74099097|NCT01544179|147747165|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.76|TWO_SIDED|95.0|0.55|1.55|||Regression, Logistic|||||1.55|0.55|0.760
74099098|NCT01544179|147747166|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.308|TWO_SIDED|95.0|0.74|2.62|||Regression, Logistic|||||2.62|0.74|0.308
74099099|NCT01544179|147747167|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.77|TWO_SIDED|95.0|0.53|1.59|||Regression, Logistic|||||1.59|0.53|0.770
74099100|NCT01544179|147747168|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.507|TWO_SIDED|95.0|0.68|1.21|||Cox Proportional Hazards|||||1.21|0.68|0.507
74099101|NCT01544179|147747169|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.725|TWO_SIDED|95.0|0.54|1.53|||Regression, Logistic|||||1.53|0.54|0.725
74099102|NCT01544179|147747170|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.575|TWO_SIDED|95.0|0.69|1.23|||Cox Proportional Hazards|||||1.23|0.69|0.575
74099103|NCT01544179|147747171|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.959|TWO_SIDED|95.0|0.61|1.68|||Regression, Logistic|||||1.68|0.61|0.959
74099104|NCT01544179|147747172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.437|TWO_SIDED|95.0|0.66|1.2|||Cox Proportional Hazards|||||1.20|0.66|0.437
74099105|NCT00049530|147747173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||bionomial proportion test|||It is of interest to test the null hypothesis of 10% plasma b-FGF response rate versus the alternative hypothesis of 30% response rate. Based on the sample size of 30 eligible patients, there will be 84% power to detect this 20% difference in b-FGF response rates. This was based on a two-sided type I error of .05, using the one-sample binomial test.||||<0.001
74099106|NCT03857750|147747193|OTHER||Mean Difference (Final Values)|82.0|||<|0.001|TWO_SIDED|95.0|40.0|124.0|||t-test, 2 sided|||Comparing onset time of rocuronium||124|40|<0.001
74099107|NCT03857750|147747193|OTHER||Odds|19.48|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon Mann-Whitney odd||95 % confidence interval is 7.63 to infinity|82||||<0.001
74099108|NCT03857750|147747195|OTHER||Mean Difference (Final Values)|31.0|||<|0.001|TWO_SIDED|95.0|14.0|48.0|||t-test, 2 sided|||Comparing duration of action of rocuronium||48|14|<0.001
74099109|NCT03857750|147747195|OTHER||Odds|6.35||||0.001|TWO_SIDED||||||Wilcoxon Mann-Whitney odd||95% Confidence interval is 2.59 to infinity.|Comparing duration of action of rocuronium||||0.001
74050870|NCT00805194|147654871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.272|TWO_SIDED|95.0|0.83|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05. HR below 1 favors nintedanib|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for all patients."||1.05|0.83|0.2720
74050871|NCT00805194|147654872|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.007|TWO_SIDED|95.0|0.75|0.96||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||0.96|0.75|0.0070
74050872|NCT00805194|147654873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0012|TWO_SIDED|95.0|0.73|0.93||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||0.93|0.73|0.0012
74050873|NCT00805194|147654874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.3067|TWO_SIDED|95.0|0.76|2.39||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||2.39|0.76|0.3067
74050874|NCT00805194|147654874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0761|TWO_SIDED|95.0|0.96|2.08||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment||2.08|0.96|0.0761
74050875|NCT00805194|147654877|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||<|0.0001|TWO_SIDED|95.0|1.35|2.09||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||2.09|1.35|<0.0001
74050876|NCT00805194|147654877|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||<|0.0001|TWO_SIDED|95.0|1.31|2.05||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on investigator's assessment||2.05|1.31|<0.0001
74050877|NCT00805194|147654879|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review||||<0.0001
74050878|NCT00805194|147654879|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment||||<0.0001
74050879|NCT00805194|147654880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7282|TWO_SIDED|95.0|0.87|1.21||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat.had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||1.21|0.87|0.7282
74050880|NCT00805194|147654881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1858|TWO_SIDED|95.0|0.77|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough||1.05|0.77|0.1858
74050881|NCT00805194|147654881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.5203|TWO_SIDED|95.0|0.91|1.2||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea||1.20|0.91|0.5203
74050882|NCT00805194|147654881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.4373|TWO_SIDED|95.0|0.82|1.09||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>= 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain||1.09|0.82|0.4373
74050883|NCT02275052|147654892|SUPERIORITY_OR_OTHER||Least squares mean difference|3.31||||0.79|TWO_SIDED|95.0|-21.12|27.74||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||27.74|-21.12|0.790
74050884|NCT02275052|147654893|SUPERIORITY_OR_OTHER||Least squares mean difference|0.206|||<|0.001|TWO_SIDED|95.0|0.167|0.246|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.246|0.167|<0.001
74050885|NCT02275052|147654894|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.346|||<|0.001|TWO_SIDED|95.0|-0.487|-0.204|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||-0.204|-0.487|<0.001
74050886|NCT02275052|147654895|SUPERIORITY_OR_OTHER||Least squares mean difference|0.259|||<|0.001|TWO_SIDED|95.0|0.194|0.324|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.324|0.194|<0.001
74050887|NCT01143116|147654896|OTHER|||||||0.625|||||||Wilcoxon (Mann-Whitney)|||||||0.6250
74050888|NCT01143116|147654896|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.7500
74050889|NCT01143116|147654897|OTHER|||||||0.875|||||||Wilcoxon (Mann-Whitney)|||||||0.8750
74050890|NCT01143116|147654897|OTHER|||||||0.625|||||||Wilcoxon (Mann-Whitney)|||||||0.6250
74050891|NCT01143116|147654898|OTHER|||||||0.0254|||||||Wilcoxon (Mann-Whitney)|||||||0.0254
74050892|NCT01143116|147654898|OTHER|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||||||0.0039
74050893|NCT01143116|147654899|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
74050894|NCT01143116|147654899|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
74050895|NCT01143116|147654900|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
74050896|NCT01143116|147654900|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
74050897|NCT01143116|147654901|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
74050898|NCT01143116|147654902|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
74050899|NCT01143116|147654903|OTHER|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
74050900|NCT01143116|147654903|OTHER|||||||0.0078|||||||Wilcoxon (Mann-Whitney)|||||||0.0078
74050901|NCT01143116|147654904|OTHER|||||||0.7188|||||||Wilcoxon (Mann-Whitney)|||||||0.7188
74050902|NCT01143116|147654904|OTHER|||||||0.6406|||||||Wilcoxon (Mann-Whitney)|||||||0.6406
74050903|NCT01143116|147654905|OTHER|||||||0.4375|||||||Wilcoxon (Mann-Whitney)|||||||0.4375
74050904|NCT01143116|147654905|OTHER|||||||0.2969|||||||Wilcoxon (Mann-Whitney)|||||||0.2969
74050905|NCT01143116|147654906|OTHER|||||||0.5391|||||||Wilcoxon (Mann-Whitney)|||||||0.5391
74050906|NCT01143116|147654906|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.0010
74050907|NCT01143116|147654907|OTHER|||||||0.4766|||||||Wilcoxon (Mann-Whitney)|||||||0.4766
74099110|NCT01696058|147747196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.078|0.135|||Mixed Model Repeated Measure|||Results are from an mixed model repeated measure (MMRM) model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563).||0.135|0.078|<.0001
74050908|NCT01143116|147654907|OTHER|||||||0.0068|||||||Wilcoxon (Mann-Whitney)|||||||0.0068
74050909|NCT01143116|147654908|OTHER|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
74050910|NCT01143116|147654908|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||||||0.4180
74050911|NCT00808028|147654915|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
74050912|NCT00808028|147654915|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0007
74050913|NCT00808028|147654915|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
74050914|NCT00808028|147654915|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
74050915|NCT00808028|147654915|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
74050916|NCT00808028|147654915|SUPERIORITY_OR_OTHER|||||||0.0392|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0392
74050917|NCT00808028|147654915|SUPERIORITY_OR_OTHER|||||||0.0225|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0225
74050918|NCT00808028|147654915|SUPERIORITY_OR_OTHER|||||||0.0244|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0244
74050919|NCT00808028|147654916|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
74050920|NCT00808028|147654916|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0004
74050921|NCT00808028|147654916|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
74099111|NCT01696058|147747197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.013||0.0029|TWO_SIDED|95.0|0.014|0.065|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550).||0.065|0.014|0.0029
74050922|NCT00808028|147654916|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
74050923|NCT00808028|147654916|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
74050924|NCT00808028|147654916|SUPERIORITY_OR_OTHER|||||||0.0036|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0036
74050925|NCT00808028|147654916|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
74050926|NCT00808028|147654916|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
74050927|NCT01797302|147654921|SUPERIORITY|||||||0.88||||||interaction term from model group\*time|Mixed Models Analysis|||||||0.88
74050928|NCT01797302|147654922|SUPERIORITY|||||||0.85||||||interaction term for group\*time|Mixed Models Analysis|||||||0.85
74050929|NCT01797302|147654923|SUPERIORITY|||||||0.61||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.61
74050930|NCT01797302|147654924|SUPERIORITY|||||||0.24||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.24
74050931|NCT01797302|147654925|SUPERIORITY|||||||0.0117||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0117
74050932|NCT01797302|147654926|SUPERIORITY|||||||0.53||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.53
74050933|NCT01797302|147654927|SUPERIORITY|||||||0.0256||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0256
74050934|NCT01797302|147654928|SUPERIORITY|||||||0.0945||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0945
74050935|NCT01797302|147654929|SUPERIORITY|||||||0.12||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.12
74099112|NCT01696058|147747198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.854|STANDARD_ERROR_OF_MEAN|0.461|<|0.0001|TWO_SIDED|95.0|-2.757|-0.951|||ANCOVA|||"Results are from ANCOVA model. Fixed effects include study, treatment and baseline.~Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039)."||-0.951|-2.757|<.0001
73888129|NCT01746901|147309537|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.2316|TWO_SIDED|95.0|-1.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|-1.0|0.2316
74050936|NCT01797302|147654930|SUPERIORITY|||||||0.0094||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0094
74050937|NCT01722552|147654997|EQUIVALENCE|The margin for non-equivalence was 25 percentage points.|Risk Ratio (RR)|1.59|||<|0.05|TWO_SIDED|95.0|1.21|2.1|||Chi-squared|||The primary analysis was by intent to treat (ITT). This included data for all randomized subjects, with post-intervention adherence measured by the last 30 days of available data; adherence over the entire 6-month intervention period was measured using all available post-intervention data. Our sample size was designed to detect a 25 percentage point difference in proportion achieving optimal adherence post-intervention.||2.1|1.21|<0.05
74050938|NCT00848172|147655002|SUPERIORITY_OR_OTHER||||||=|0.345||95.0|||||Mixed Models Analysis|||||||=0.345
74050939|NCT00848172|147655003|SUPERIORITY_OR_OTHER||||||=|0.031||95.0|||||Mixed Models Analysis|||||||=0.031
74050940|NCT00721136|147655007|OTHER|||||||||||||||||Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.|Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.|||
74050941|NCT00732199|147655010|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||T- test was conducted to compare the 2 groups.||||<0.05
74050942|NCT00732199|147655011|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Compares control vs hypoxia trials vs recovery post-hypoxia||||||<0.05
74050943|NCT00732199|147655012|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74050944|NCT00732199|147655013|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74050945|NCT01051856|147655056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Chi-squared|||||||0.35
74050946|NCT02176226|147655059|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
74050947|NCT02176226|147655060|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
74050948|NCT01412333|147655076|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.532|||<|0.0001|TWO_SIDED|95.0|0.397|0.714|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||0.714|0.397|< 0.0001
74099113|NCT01696058|147747199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.071|0.129|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.129|0.071|<.0001
74050949|NCT01412333|147655077|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||=|0.0169|TWO_SIDED|95.0|0.42|0.92|||Log Rank|||Time to onset of CDP at week 12||0.92|0.42|= 0.0169
74050950|NCT01412333|147655078|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.051|||<|0.0001||95.0|0.029|0.089|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.089|0.029|< 0.0001
74050951|NCT01412333|147655079|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.171|||<|0.0001||95.0|0.13|0.225|||Negative Binomial Model||Adjusted by baseline T2 lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.225|0.130|< 0.0001
74050952|NCT01412333|147655080|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.14|||=|0.4019|TWO_SIDED|95.0|0.84|1.56|||CMH Chi-Squared test (stratified)|Stratified by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||||1.56|0.84|= 0.4019
74050953|NCT01412333|147655081|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||=|0.037|TWO_SIDED|95.0|0.4|0.98|||Log Rank|||Time to onset of CDP at week 24||0.98|0.40|= 0.037
74050954|NCT01412333|147655082|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.357|||<|0.0001||95.0|0.272|0.47|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.47|0.272|< 0.0001
74050955|NCT01412333|147655083|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.107|STANDARD_ERROR_OF_MEAN|0.037|=|0.004|TWO_SIDED|95.0|0.034|0.18|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.180|0.034|= 0.004
74050956|NCT01412333|147655084|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.112|STANDARD_ERROR_OF_MEAN|0.066|=|0.09|TWO_SIDED|95.0|-0.018|0.241|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 14.9%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.241|-0.018|= 0.09
74050957|NCT01412333|147655085|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|1.159|STANDARD_ERROR_OF_MEAN|0.564|=|0.0404|TWO_SIDED|95.0|0.051|2.268|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||2.268|0.051|= 0.0404
74050958|NCT01412333|147655086|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.81|||<|0.0001|TWO_SIDED|95.0|1.41|2.32|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (\<4.0 vs. \>=4.0).||||2.32|1.41|< 0.0001
74050959|NCT00750867|147655095|SUPERIORITY_OR_OTHER|||||||0.0128||||||The P-Value was obtained by comparing the UMSARS-I scores at final visit and at baseline.|ANOVA|||||||0.0128
74050960|NCT00750867|147655095|SUPERIORITY_OR_OTHER|||||||0.025||||||The P-Value was obtained by comparing the UMSARS-II scores at final visit and at baseline.|ANOVA|||||||0.025
74050961|NCT00242710|147655101|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|2.37|||<|0.001|TWO_SIDED|95.0|1.56|3.18|||ANCOVA|||An analysis of covariance (ANCOVA) model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.18|1.56|<0.001
74050962|NCT00242710|147655101|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|||<|0.001|TWO_SIDED|95.0|1.56|3.17|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.17|1.56|<0.001
74050963|NCT00242710|147655101|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78|||<|0.001|TWO_SIDED|95.0|2.81|4.76|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.76|2.81|<0.001
74050964|NCT00242710|147655103|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|||<|0.001|TWO_SIDED|95.0|0.97|2.24|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.24|0.97|<0.001
74050965|NCT00242710|147655103|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|||<|0.001|TWO_SIDED|95.0|1.19|2.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.46|1.19|<0.001
74050966|NCT00242710|147655103|SUPERIORITY_OR_OTHER||LS Mean Difference|2.46|||<|0.001|TWO_SIDED|95.0|1.69|3.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.23|1.69|<0.001
74050967|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.373|TWO_SIDED|95.0|-0.8|2.12|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.12|-0.80|0.373
73881405|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2327|TWO_SIDED|95.0|0.68|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.95|0.68|0.2327
74050968|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.738|TWO_SIDED|95.0|-1.7|2.4|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.40|-1.70|0.738
74050969|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.539|TWO_SIDED|95.0|-1.41|2.71|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.71|-1.41|0.539
74050970|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09||||0.233|TWO_SIDED|95.0|-0.71|2.9|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.90|-0.71|0.233
74050971|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.605|TWO_SIDED|95.0|-1.39|2.39|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.39|-1.39|0.605
73881406|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1359|TWO_SIDED|95.0|0.79|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.70|0.79|0.1359
74019142|NCT00428597|147590376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4404||||0.6058|TWO_SIDED|95.0|-6.9|4.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||4|-6.9|0.6058
74019143|NCT00428597|147590377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5575||||0.3008|TWO_SIDED|95.0|-10.3|3.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||3.2|-10.3|0.3008
74019144|NCT00428597|147590378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7911||||0.323|TWO_SIDED|95.0|-2.8|8.3||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||8.3|-2.8|0.3230
74019145|NCT00428597|147590379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5113||||0.7113|TWO_SIDED|95.0|-6.5|9.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||9.5|-6.5|0.7113
74019146|NCT00428597|147590380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6672||||0.6487|TWO_SIDED|95.0|-8.9|5.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||5.5|-8.9|0.6487
74019147|NCT00428597|147590381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||0.6545|TWO_SIDED|95.0|-6.4|10.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||10.1|-6.4|0.6545
74019148|NCT00428597|147590382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0035||||0.1936|TWO_SIDED|95.0|-10.0|2.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||2|-10|0.1936
74019149|NCT00428597|147590383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.3801|||<|0.0001|TWO_SIDED|95.0|14.3|28.4||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||28.4|14.3|<0.0001
74019150|NCT00428597|147590384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.23||||0.1339|TWO_SIDED|95.0|-1.6|12.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||12.1|-1.6|0.1339
74019151|NCT00428597|147590385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7816||||0.6138|TWO_SIDED|95.0|-5.1|8.7||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||8.7|-5.1|0.6138
74019152|NCT00428597|147590386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2778||||0.9367|TWO_SIDED|95.0|-6.6|7.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||7.1|-6.6|0.9367
74019153|NCT00428597|147590387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.753||||0.0372|TWO_SIDED|95.0|0.5|15.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||15|0.5|0.0372
74019154|NCT00428597|147590388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1463||||0.6939|TWO_SIDED|95.0|-4.6|6.9||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||6.9|-4.6|0.6939
74019155|NCT00428597|147590389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5128||||0.3711|TWO_SIDED|95.0|-11.2|4.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||4.2|-11.2|0.3711
74019156|NCT01469000|147590390|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.009|TWO_SIDED|95.0|0.48|0.93||1-sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||0.93|0.48|0.009
74019157|NCT01469000|147590391|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.005|TWO_SIDED|95.0|0.46|0.9||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||0.90|0.46|0.005
74019158|NCT01469000|147590392|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.105|TWO_SIDED|95.0|0.51|1.16||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||1.16|0.51|0.105
74019159|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.77|1.78||||||Patient-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.78|0.77|
74019160|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.6|1.42||||||Patient-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.42|0.60|
74019161|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.84|2.3||||||Patient-rated Cough: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||2.30|0.84|
74019162|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.65|1.71||||||Patient-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.71|0.65|
74019163|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.32|1.02||||||Patient-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.02|0.32|
74019164|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.64|1.91||||||Patient-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.91|0.64|
74019165|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.68|1.77||||||Patient-rated Overall Symptoms: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.77|0.68|
74019166|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.88|2.17||||||Patient-rated Interference: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||2.17|0.88|
74019167|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.72|1.74||||||Patient-rated Quality of Life: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.74|0.72|
74050972|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|1.23||||0.305|TWO_SIDED|95.0|-1.12|3.57|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.57|-1.12|0.305
74050973|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22||||0.299|TWO_SIDED|95.0|-1.08|3.52|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.52|-1.08|0.299
74050974|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62||||0.092|TWO_SIDED|95.0|-0.27|3.51|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.51|-0.27|0.092
74050975|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55||||0.08|TWO_SIDED|95.0|-0.18|3.29|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.29|-0.18|0.080
74050976|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04||||0.279|TWO_SIDED|95.0|-0.85|2.92|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.92|-0.85|0.279
74050977|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|1.13||||0.26|TWO_SIDED|95.0|-0.84|3.11|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.11|-0.84|0.260
74050978|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.618|TWO_SIDED|95.0|-1.5|2.52|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.52|-1.50|0.618
74050979|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.81|TWO_SIDED|95.0|-3.78|2.96|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.96|-3.78|0.810
74050980|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.654|TWO_SIDED|95.0|-1.14|1.81|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.81|-1.14|0.654
74050981|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.834|TWO_SIDED|95.0|-1.84|2.28|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.28|-1.84|0.834
74050982|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.744|TWO_SIDED|95.0|-2.41|1.72|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.72|-2.41|0.744
74050983|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.909|TWO_SIDED|95.0|-1.7|1.91|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.91|-1.70|0.909
74050984|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.963|TWO_SIDED|95.0|-1.94|1.85|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.85|-1.94|0.963
74050985|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.625|TWO_SIDED|95.0|-1.77|2.94|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.94|-1.77|0.625
74050986|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.947|TWO_SIDED|95.0|-2.39|2.23|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.23|-2.39|0.947
74050987|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.505|TWO_SIDED|95.0|-1.25|2.53|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.53|-1.25|0.505
74050988|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.564|TWO_SIDED|95.0|-1.23|2.25|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.25|-1.23|0.564
74050989|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.739|TWO_SIDED|95.0|-2.21|1.57|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.57|-2.21|0.739
74050990|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.766|TWO_SIDED|95.0|-2.27|1.67|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.67|-2.27|0.766
74050991|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.931|TWO_SIDED|95.0|-1.92|2.1|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.10|-1.92|0.931
74050992|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.911|TWO_SIDED|95.0|-3.17|3.56|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.56|-3.17|0.911
74050993|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.003|TWO_SIDED|95.0|0.92|4.3|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||4.30|0.92|0.003
74050994|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|4.18|||<|0.001|TWO_SIDED|95.0|1.79|6.58|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.58|1.79|<0.001
74050995|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|3.45||||0.005|TWO_SIDED|95.0|1.03|5.86|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.86|1.03|0.005
74050996|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|3.15||||0.004|TWO_SIDED|95.0|1.01|5.3|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.30|1.01|0.004
74050997|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.023|TWO_SIDED|95.0|0.36|4.87|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||4.87|0.36|0.023
74050998|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75||||0.008|TWO_SIDED|95.0|0.96|6.54|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.54|0.96|0.008
74050999|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|3.52||||0.012|TWO_SIDED|95.0|0.78|6.26|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.26|0.78|0.012
74051000|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|3.81|||<|0.001|TWO_SIDED|95.0|1.55|6.07|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.07|1.55|<0.001
74051001|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75|||<|0.001|TWO_SIDED|95.0|1.68|5.83|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.83|1.68|<0.001
74051002|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.004|TWO_SIDED|95.0|1.05|5.54|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.54|1.05|0.004
74051003|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63||||0.175|TWO_SIDED|95.0|-0.73|3.99|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.99|-0.73|0.175
74051004|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|1.35||||0.27|TWO_SIDED|95.0|-1.05|3.75|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.75|-1.05|0.270
74051005|NCT00242710|147655104|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78||||0.077|TWO_SIDED|95.0|-0.41|7.97|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||7.97|-0.41|0.077
74051006|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.826|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.826
74051007|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.534|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.534
74051008|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||1.000
74051009|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.516|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.516
74051010|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.446
74051011|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.218
74051012|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||1.000
74051013|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
74051014|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.733
74051015|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.736|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.736
74051016|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.449
74051017|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.489|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.489
74051018|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.163|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.163
74051019|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.813|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.813
74051020|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.777|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.777
74051021|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.448|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.448
74051022|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.507|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.507
74051023|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.669|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.669
74051024|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.281|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.281
74051025|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.689
74051026|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.437|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||0.437
74051027|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||1.000
74051028|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||1.000
74051029|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.227
74051030|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.758
74051031|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.554
74051032|NCT00242710|147655105|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||<0.001
74051033|NCT00242710|147655105|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||<0.001
74099114|NCT01696058|147747200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.072|0.164|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.164|0.072|<.0001
74099115|NCT01696058|147747201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.057|0.152|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.152|0.057|<.0001
74099116|NCT01696058|147747202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.022||0.1156|TWO_SIDED|95.0|-0.008|0.076|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550)."||0.076|-0.008|0.1156
74099117|NCT01696058|147747203|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|7.237|STANDARD_ERROR_OF_MEAN|2.145||0.0008|TWO_SIDED|95.0|3.028|11.446|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)."||11.446|3.028|0.0008
74099118|NCT01696058|147747204|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.568|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-0.8|-0.336|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.336|-0.800|<.0001
74051034|NCT00242710|147655105|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||<0.001
74051035|NCT00242710|147655105|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||<0.001
74051036|NCT00242710|147655105|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||<0.001
74051037|NCT00242710|147655105|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||<0.001
74051038|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.008
74051039|NCT00242710|147655105|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||<0.001
74099119|NCT01696058|147747205|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 1|-0.09|STANDARD_ERROR_OF_MEAN|0.045||0.0467|TWO_SIDED|95.0|-0.178|-0.001|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.001|-0.178|0.0467
74099120|NCT01696058|147747206|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.483|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.668|-0.298|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.298|-0.668|<.0001
74099121|NCT01934335|147747210|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
74051040|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.005
74051041|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.008
74051042|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.062
74051043|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.007
74051044|NCT00242710|147655105|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.029
74051045|NCT00242710|147655107|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|||<|0.001|TWO_SIDED|95.0|1.92|4.58|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.58|1.92|<0.001
74051046|NCT00242710|147655107|SUPERIORITY_OR_OTHER||LS Mean Difference|3.14|||<|0.001|TWO_SIDED|95.0|1.83|4.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.46|1.83|<0.001
74051047|NCT00242710|147655107|SUPERIORITY_OR_OTHER||LS Mean Difference|4.68|||<|0.001|TWO_SIDED|95.0|3.13|6.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||6.23|3.13|<0.001
74051048|NCT00242710|147655108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.83|||<|0.001|TWO_SIDED|95.0|0.8|2.87|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.87|0.80|<0.001
74051049|NCT00242710|147655108|SUPERIORITY_OR_OTHER||LS Mean Difference|1.94|||<|0.001|TWO_SIDED|95.0|0.92|2.97|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.97|0.92|<0.001
74051050|NCT00242710|147655108|SUPERIORITY_OR_OTHER||LS Mean Difference|2.38|||<|0.001|TWO_SIDED|95.0|1.17|3.59|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.59|1.17|<0.001
74051051|NCT00808132|147655119|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|1.51|||<|0.001|TWO_SIDED|95.0|0.822|2.201|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.201|0.822|<0.001
74051052|NCT00808132|147655119|SUPERIORITY_OR_OTHER||LS Mean Difference|1.87|||<|0.001|TWO_SIDED|95.0|1.209|2.533|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.533|1.209|<0.001
73881407|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.35||||0.0258|TWO_SIDED|95.0|1.16|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.69|1.16|0.0258
74019168|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|0.97|2.49||||||Observer-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.49|0.97|
74099122|NCT01934335|147747211|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
74099123|NCT01934335|147747212|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
74099124|NCT05384171|147747216|SUPERIORITY||Partial Eta Squared (effect size)|0.02||||0.617|TWO_SIDED||||||ANCOVA|||||||.617
73881408|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0076|TWO_SIDED|95.0|1.51|15.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.04|1.51|0.0076
74019169|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.82|1.93||||||Observer-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.93|0.82|
74019170|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.72|2.15||||||Observer-rated Cough:Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.15|0.72|
74019171|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.64|1.83||||||Observer-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.83|0.64|
74019172|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.6|2.91||||||Observer-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.91|0.60|
74019173|NCT01469000|147590396|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.41|1.03||||||Observer-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.03|0.41|
74019174|NCT00632853|147590429|SUPERIORITY|||||||0.8741|||||||Log Rank|||||||0.8741
74019175|NCT00654498|147590482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.52|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|-6.58|-2.46|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-2.46|-6.58|<0.0001
74019176|NCT00654498|147590483|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
74019177|NCT00654498|147590484|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
74019178|NCT00654498|147590485|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
74019179|NCT00654498|147590486|SUPERIORITY_OR_OTHER|||||||0.1386||95.0|||||Chi-squared|||||||0.1386
74019180|NCT00654498|147590487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.14|-0.83|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.83|-2.14|<0.0001
74019181|NCT00654498|147590488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-1.99|-0.73|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.73|-1.99|<0.0001
74019182|NCT00654498|147590489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.0|-0.72|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.72|-2.00|<0.0001
74019183|NCT00654498|147590490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.26||0.0402|TWO_SIDED|95.0|-1.06|-0.02|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.02|-1.06|0.0402
74099125|NCT05384171|147747218|SUPERIORITY||Partial Eta Squared (effect size)|0.089||||0.214|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group intention follow-up means are equal when controlling for covariates (i.e., baseline intention scores and age)||||.214
74099126|NCT05384171|147747218|SUPERIORITY||Partial Eta Squared (effect size)|0.001||||0.894|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group attitude follow-up means are equal when controlling for covariates (i.e., baseline attitude scores and age)||||.894
74099127|NCT05384171|147747218|SUPERIORITY||Partial Eta Squared (Effect Size)|0.053||||0.359|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group social norms follow-up means are equal when controlling for covariates (i.e., baseline social norms scores and age)||||.359
74099128|NCT05384171|147747218|SUPERIORITY||Partial Eta Squared (Effect Size)|0.058||||0.322|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group perceived behavioral control follow-up means are equal when controlling for covariates (i.e., baseline perceived behavioral control scores and age)||||.322
74099129|NCT05384171|147747219|SUPERIORITY||Partial Eta Squared (effect size)|0.001||||0.891|TWO_SIDED||||||ANCOVA|||||||.891
73881409|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.36||||0.1088|TWO_SIDED|95.0|0.83|6.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.75|0.83|0.1088
73881410|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|4.89||||0.0045|TWO_SIDED|95.0|1.64|14.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||14.62|1.64|0.0045
74051053|NCT00808132|147655120|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.017|TWO_SIDED|95.0|0.139|1.47|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.470|0.139|0.017
74051054|NCT00808132|147655120|SUPERIORITY_OR_OTHER||LS Mean Difference|1.19|||<|0.001|TWO_SIDED|95.0|0.556|1.83|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.830|0.556|<0.001
74051055|NCT00808132|147655121|SUPERIORITY_OR_OTHER||LS Mean Difference|1.32|||<|0.001|TWO_SIDED|95.0|0.901|1.742|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.742|0.901|<0.001
74051056|NCT00808132|147655121|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21|||<|0.001|TWO_SIDED|95.0|0.756|1.671|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.671|0.756|<0.001
74051057|NCT00808132|147655121|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|1.152|1.962|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.962|1.152|<0.001
74051058|NCT00808132|147655121|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|1.164|2.044|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.044|1.164|<0.001
74051059|NCT00808132|147655122|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Fisher Exact|||||||0.138
74051060|NCT00808132|147655122|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
74099130|NCT01421511|147747221|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the early clinical response rates at 48 to 72 Hours after the first infusion of study drug using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-3.0|8.2|||||Risk difference corresponds to the tedizolid responder rate minus the linezolid responder rate.|||8.2|-3.0|
73881411|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0493|TWO_SIDED|95.0|1.0|7.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.50|1.00|0.0493
74051061|NCT00808132|147655122|SUPERIORITY_OR_OTHER|||||||0.765|TWO_SIDED||||||Fisher Exact|||||||0.765
74051062|NCT00808132|147655122|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
73881412|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0376|TWO_SIDED|95.0|1.06|8.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.41|1.06|0.0376
73888130|NCT01746901|147309538|SUPERIORITY_OR_OTHER||LS Mean Difference|38.8|||<|0.0001|TWO_SIDED|95.0|26.4|51.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.3|26.4|<0.0001
74051063|NCT00808132|147655122|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
74051064|NCT00808132|147655123|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.832|TWO_SIDED|95.0|-0.632|0.509|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.509|-0.632|0.832
74051065|NCT00808132|147655123|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.651|TWO_SIDED|95.0|-0.696|0.436|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.436|-0.696|0.651
74051066|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051067|NCT00808132|147655124|SUPERIORITY_OR_OTHER|||||||0.0074|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0074
74051068|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051069|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051070|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051071|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051072|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051073|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051074|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051075|NCT00808132|147655124|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0016
73881413|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0723|TWO_SIDED|95.0|0.92|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.94|0.92|0.0723
73881414|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0396|TWO_SIDED|95.0|1.06|9.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.17|1.06|0.0396
73881415|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|6.18||||0.0031|TWO_SIDED|95.0|1.85|20.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||20.67|1.85|0.0031
73881416|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1044|TWO_SIDED|95.0|0.83|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.96|0.83|0.1044
73881417|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0029|TWO_SIDED|95.0|1.78|16.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.75|1.78|0.0029
73881418|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0364|TWO_SIDED|95.0|1.07|8.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.45|1.07|0.0364
73881419|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6396|TWO_SIDED|95.0|0.47|3.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.37|0.47|0.6396
74051076|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051077|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051078|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
73881420|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4378|TWO_SIDED|95.0|0.55|3.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.91|0.55|0.4378
73881421|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.95||||0.2045|TWO_SIDED|95.0|0.7|5.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.44|0.70|0.2045
73881422|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.54||||0.0958|TWO_SIDED|95.0|0.85|7.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.62|0.85|0.0958
73881423|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.7||||0.321|TWO_SIDED|95.0|0.6|4.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.85|0.60|0.3210
73881424|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.75||||0.0199|TWO_SIDED|95.0|1.23|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.39|1.23|0.0199
73881425|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1219|TWO_SIDED|95.0|0.8|6.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.36|0.80|0.1219
74019184|NCT00654498|147590491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.0771|TWO_SIDED|95.0|-0.69|0.04|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||0.04|-0.69|0.0771
74019185|NCT00654498|147590492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.25||0.0048|TWO_SIDED|95.0|-1.2|-0.22|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.22|-1.20|0.0048
74019186|NCT00654498|147590493|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||||<0.0001
74019187|NCT01462266|147590512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.009|TWO_SIDED|95.0|-8.3|-1.2|||Longitudinal data analysis|Adjusting for participant's use of metformin at Visit 1/Screening Visit (i.e., on metformin, or not on metformin)||||-1.2|-8.3|0.009
74019188|NCT01106846|147590517|SUPERIORITY_OR_OTHER|||||||0.947|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.947
74051079|NCT00808132|147655124|SUPERIORITY_OR_OTHER|||||||0.1058|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.1058
74051080|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
73881426|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.72||||0.2975|TWO_SIDED|95.0|0.62|4.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.76|0.62|0.2975
74099131|NCT01421511|147747222|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the programmatic clinical response at the EOT visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-6.1|4.1||Hierarchical testing procedure of Westfall and Krishen used to control for inflation of the overall type I error rate. If NI is declared for the primary, NI will be tested for the secondary outcomes in this order: Secondary Outcomes Measures 2 to 5.|||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||4.1|-6.1|
74099132|NCT01421511|147747223|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the EOT Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-8.8|0.3|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||0.3|-8.8|
74099133|NCT01421511|147747224|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-4.8|5.3|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||5.3|-4.8|
74099134|NCT01421511|147747225|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-3.7|||||TWO_SIDED|95.0|-7.7|0.2|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||0.2|-7.7|
74099135|NCT01421511|147747226|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-3.3|5.6|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen without stratification.||5.6|-3.3|
74099136|NCT01421511|147747227|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-3.2|4.9|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen without stratification.||4.9|-3.2|
74099137|NCT00106964|147747234|SUPERIORITY_OR_OTHER|||||||0.044|||||||Chi-squared|||||||0.0440
74099138|NCT00106964|147747234|SUPERIORITY_OR_OTHER|||||||0.0157|||||||Chi-squared|||||||0.0157
74019189|NCT01332071|147590525|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.58|||||TWO_SIDED|90.0|93.44|99.83|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.83|93.44|
74019190|NCT01332071|147590526|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.76|||||TWO_SIDED|90.0|93.25|102.5|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||102.50|93.25|
74019191|NCT01332071|147590527|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.47|||||TWO_SIDED|90.0|93.32|99.72|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.72|93.32|
74019192|NCT01332071|147590528|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|95.79|||||TWO_SIDED|90.0|91.67|100.1|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||100.10|91.67|
74019193|NCT01332071|147590529|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|94.86|||||TWO_SIDED|90.0|90.7|99.22|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.22|90.70|
74019194|NCT01332071|147590530|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.88|||||TWO_SIDED|90.0|93.15|102.86|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||102.86|93.15|
74019195|NCT01738971|147590534|SUPERIORITY_OR_OTHER||relative probability|3.13|||<|0.001||95.0|1.9|5.13|||t-test, 2 sided|see above description of analysis taking into account cluster randomisation||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in progestogen only pill group compared to control."||5.13|1.90|<0.001
74051081|NCT00808132|147655124|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0024
74051082|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051083|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051084|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051085|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
73881427|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.75||||0.2763|TWO_SIDED|95.0|0.64|4.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.80|0.64|0.2763
73881428|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.33||||0.1235|TWO_SIDED|95.0|0.79|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.82|0.79|0.1235
73881429|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|4.24||||0.019|TWO_SIDED|95.0|1.27|14.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||14.19|1.27|0.0190
73881430|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.98||||0.2213|TWO_SIDED|95.0|0.66|5.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.93|0.66|0.2213
74051086|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051087|NCT00808132|147655124|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0012
74051088|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051089|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051090|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051091|NCT00808132|147655124|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0029
74051092|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051093|NCT00808132|147655124|SUPERIORITY_OR_OTHER|||||||0.0046|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0046
74051094|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051095|NCT00808132|147655124|SUPERIORITY_OR_OTHER|||||||0.0043|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0043
74051096|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051097|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051098|NCT00808132|147655124|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0016
74051099|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051100|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051101|NCT00808132|147655124|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
74051102|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.546|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.546
74051103|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.821|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.821
74051104|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.698|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.698
74051105|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.446
74051106|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.892
74051107|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.810
74051108|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.473|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.473
74051109|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.030
74051110|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.453|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.453
74051111|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.391
74051112|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.407|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.407
74051113|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.644|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.644
74051114|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.666|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.666
74051115|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.641
74051116|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.361|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.361
74051117|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.100
74099139|NCT00106964|147747238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.5822||95.0|||||Regression, Cox|||||||0.5822
74099140|NCT00106964|147747238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.8698||95.0|||||Regression, Cox|||||||0.8698
74099141|NCT00106964|147747239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.29||||0.0853|TWO_SIDED|95.0|0.07|1.19|||Regression, Logistic||Adjusted odds ratio (OR) Odds ratio depends on CD4 count resulting from interaction. For example, OR=0.29 for CD4 count = 0; OR= 2.91 for CD4 count = 460 (median CD4 count for the evaluable study population).|||1.19|0.07|0.0853
74099142|NCT00106964|147747239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.0244|TWO_SIDED|95.0|1.09|3.63|||Regression, Logistic||Adjusted odds ratio|||3.63|1.09|0.0244
74051118|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.142|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.142
74051119|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.906
74051120|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.798|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.798
74051121|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.258|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.258
74051122|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.058
74051123|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.230
74051124|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.360
74051125|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.892
74051126|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.912|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.912
74051127|NCT00808132|147655126|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.791
74051128|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.93||||0.253|TWO_SIDED|95.0|-7.96|2.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.10|-7.96|0.253
74051129|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.84||||0.127|TWO_SIDED|95.0|-8.78|1.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.10|-8.78|0.127
74051130|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.15||||0.18|TWO_SIDED|95.0|-7.76|1.46|||ANCOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.46|-7.76|0.180
74051131|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.67||||0.247|TWO_SIDED|95.0|-7.19|1.85|||ANOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.85|-7.19|0.247
74051132|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63||||0.726|TWO_SIDED|95.0|-4.15|2.9|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.90|-4.15|0.726
74051133|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.17||||0.218|TWO_SIDED|95.0|-5.63|1.29|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.29|-5.63|0.218
74051134|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.996|TWO_SIDED|95.0|-3.85|3.87|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||3.87|-3.85|0.996
74051135|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean DIfference|0.83||||0.665|TWO_SIDED|95.0|-2.94|4.6|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||4.60|-2.94|0.665
74051136|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|2.76||||0.368|TWO_SIDED|95.0|-3.26|8.78|||ANOVA|||Sleep adequacy: Month 3, ANCOVA model was used with treatment and region as factors and baseline as a covariate.||8.78|-3.26|0.368
74099143|NCT03207243|147747241|OTHER||Median Rate Ratio|0.82|||||TWO_SIDED|95.0|0.66|0.99|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented|||0.99|0.66|
74099144|NCT03207243|147747246|OTHER||Median Rate Ratio|0.71|||||TWO_SIDED|95.0|0.44|1.01|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented|||1.01|0.44|
74051137|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|2.84||||0.345|TWO_SIDED|95.0|-3.07|8.75|||ANCOVA|||Sleep adequacy: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||8.75|-3.07|0.345
74051138|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.35||||0.482|TWO_SIDED|95.0|-5.12|2.42|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.42|-5.12|0.482
74051139|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean DIfference|-2.15||||0.254|TWO_SIDED|95.0|-5.86|1.55|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.55|-5.86|0.254
74051140|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97||||0.308|TWO_SIDED|95.0|-5.76|1.82|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.82|-5.76|0.308
74051141|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.48||||0.19|TWO_SIDED|95.0|-6.2|1.23|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.23|-6.20|0.190
74051142|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.55|TWO_SIDED|95.0|-0.32|0.17|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.17|-0.32|0.550
74051143|NCT00808132|147655127|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.477|TWO_SIDED|95.0|-0.15|0.32|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.32|-0.15|0.477
74051144|NCT00808132|147655129|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||<0.001
74051145|NCT00808132|147655129|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||<0.001
74051146|NCT00808132|147655129|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.680
74051147|NCT00808132|147655129|SUPERIORITY_OR_OTHER|||||||0.493|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.493
74051148|NCT00808132|147655129|SUPERIORITY_OR_OTHER|||||||0.698|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.698
74051149|NCT00808132|147655129|SUPERIORITY_OR_OTHER|||||||0.055|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.055
74051150|NCT00808132|147655129|SUPERIORITY_OR_OTHER|||||||0.428|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.428
74051151|NCT00808132|147655129|SUPERIORITY_OR_OTHER|||||||0.071|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.071
74051152|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.624|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.624
74051153|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.868|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.868
74051154|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.087
74051155|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.425
74051156|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.307|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.307
74051157|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.689
74051158|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.285|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.285
74051159|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
74051160|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.065
74051161|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.014
74051162|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||1.000
74051163|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.226|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.226
74051164|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||1.000
74099145|NCT03207243|147747247|OTHER|||||||0.044|||||||Log Rank|||||||0.044
74099146|NCT03207243|147747291|OTHER||Percent change|-93.4|||<|0.001|TWO_SIDED|95.0|-94.9|-91.7||Week 4|mixed model repeated measures analysis|||||-91.7|-94.9|<0.001
74099147|NCT03207243|147747291|OTHER||Percent change|-92.9|||<|0.001|TWO_SIDED|95.0|-94.8|-90.3||Week 8|mixed model repeated measures analysis|||||-90.3|-94.8|<0.001
74099148|NCT03207243|147747291|OTHER||Percent change|-93.2|||<|0.001|TWO_SIDED|95.0|-95.4|-90.0||Week 12|mixed model repeated measures analysis|||||-90.0|-95.4|<0.001
74051165|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051166|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051167|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051168|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051169|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051170|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051171|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||< 0.001
74099149|NCT03207243|147747291|OTHER||Percent change|-93.3|||<|0.001|TWO_SIDED|95.0|-95.3|-90.4||Week 16|mixed model repeated measures analysis|||||-90.4|-95.3|<0.001
74099150|NCT03207243|147747292|OTHER||Percent change|2300.4|||<|0.001|TWO_SIDED|95.0|1833.9|2879.3||Week 4|mixed model repeated measures analysis|||||2879.3|1833.9|<0.001
73881431|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|5.88||||0.005|TWO_SIDED|95.0|1.71|20.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||20.25|1.71|0.0050
73881432|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.39||||0.1053|TWO_SIDED|95.0|0.83|6.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.85|0.83|0.1053
73881433|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0991|TWO_SIDED|95.0|0.85|6.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.72|0.85|0.0991
73881434|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.93||||0.2056|TWO_SIDED|95.0|0.7|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.32|0.70|0.2056
73881435|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0407|TWO_SIDED|95.0|1.05|9.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.57|1.05|0.0407
74051172|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051173|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051174|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051175|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051176|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||< 0.001
74099151|NCT03207243|147747292|OTHER||Percent change|2507.7|||<|0.001|TWO_SIDED|95.0|1924.2|3259.4||Week 8|mixed model repeated measures analysis|||||3259.4|1924.2|<0.001
74099152|NCT03207243|147747292|OTHER||Percent change|2162.2|||<|0.001|TWO_SIDED|95.0|1489.1|3120.3||Week 12|mixed model repeated measures analysis|||||3120.3|1489.1|<0.001
74099153|NCT03207243|147747292|OTHER||Percent change|2663.0|||<|0.001|TWO_SIDED|95.0|1994.6|3544.8||Week 16|mixed model repeated measures analysis|||||3544.8|1994.6|<0.001
74099154|NCT00168818|147747293|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-0.7||||0.5648||95.0|-2.9|1.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.6|-2.9|0.5648
73881436|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0059|TWO_SIDED|95.0|1.63|18.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.30|1.63|0.0059
73881437|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.85||||0.023|TWO_SIDED|95.0|1.2|12.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.30|1.20|0.0230
73881438|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|7.36||||0.0015|TWO_SIDED|95.0|2.14|25.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||25.29|2.14|0.0015
73881439|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0248|TWO_SIDED|95.0|1.17|10.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.16|1.17|0.0248
73881440|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1091|TWO_SIDED|95.0|0.82|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.83|0.82|0.1091
73881441|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3054|TWO_SIDED|95.0|0.61|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.75|0.61|0.3054
74051177|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051178|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.317|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.317
74051179|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.531
74051180|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.610
74051181|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.848
74051182|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.551|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.551
74051183|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.300
74051184|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.299
74051185|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
74051186|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.660
74051187|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.199
74051188|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.770
74051189|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||1.000
74051190|NCT00808132|147655130|SUPERIORITY_OR_OTHER|||||||0.769|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.769
74051191|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051192|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051193|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051194|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051195|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051196|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||< 0.001
74099155|NCT00168818|147747293|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|1.9||||0.1339||95.0|-0.6|4.4||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.4|-0.6|0.1339
74099156|NCT00168818|147747294|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.8||||0.3256||95.0|-2.5|0.8|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||0.8|-2.5|0.3256
74099157|NCT00168818|147747294|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.4||||0.7052||95.0|-1.5|2.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.2|-1.5|0.7052
74051197|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051198|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051199|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||< 0.001
74099158|NCT00168818|147747295|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.1||||0.1863||95.0|-2.7|0.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||0.5|-2.7|0.1863
74051200|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051201|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051202|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051203|NCT00808132|147655130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||< 0.001
74051204|NCT01948791|147655135|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of MeanP-MeanB+1.40, the post-baseline noninferiority to baseline can be concluded. If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of 0, superiority can be concluded.|||||<|0.001|||||||t-test, 1 sided|||The hypothesis to test the non-inferiority of post-baseline change in ADAS-Cog from baseline was: H0: μP - μB ≥ 1.40, Ha: μP - μB \< 1.40 where μP and μB are the ADAS-Cog score (actual) at 16 weeks of Rivastigmine treatment and the baseline ADAS-Cog score (actual), respectively.||||<0.001
74051205|NCT03490734|147655146|SUPERIORITY|||||||0.52||||||Corrected for multiple comparisons by using the threshold free cluster enhancement, nonparametric thresholding algorithm in FMRIB Software Library (FSL), resulting in a family-wise error rate (FWE) corrected significance threshold of p-FWE\<0.05|ANCOVA|||Whole-brain analyses were used. No clusters of significant activation were detected.||||0.52
74051206|NCT03490734|147655147|SUPERIORITY|||||||0.016||||||Corrected for multiple comparisons by using the threshold free cluster enhancement (TFCE), nonparametric thresholding algorithm in FSL, resulting in a family-wise error rate corrected significance threshold of p-FWE \< 0.05|ANCOVA|||||||0.016
74051207|NCT02815982|147655162|SUPERIORITY||Mean Difference (Final Values)|-8.7|||<|0.05|TWO_SIDED|95.0|-14.6|-2.7|||t-test, 2 sided|||||-2.7|-14.6|<.05
74051208|NCT02815982|147655163|SUPERIORITY||Mean Difference (Final Values)|35.6|||<|0.001|TWO_SIDED|95.0|-559.0|630.2||p value was the actual signficance level|t-test, 2 sided|||We compared Post-intervention scores||630.2|-559.0|<.001
74051209|NCT02815982|147655164|SUPERIORITY||Mean Difference (Final Values)|0.47|||<|0.001|TWO_SIDED|95.0|-2.3|3.3||controlling for caregiver BMI at baseline and PCS BMI percentile at baseline|t-test, 2 sided|||We compared Post-intervention BMI||3.3|-2.3|<.001
74099159|NCT00168818|147747295|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.702||95.0|-1.4|2.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.1|-1.4|0.7020
74019196|NCT01738971|147590534|SUPERIORITY_OR_OTHER||relative probability|2.57||||0.006||95.0|1.55|4.27||see above comments regarding analysis taking cluster randomised account into consideration|t-test, 2 sided|||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in rapid access group compared to control."||4.27|1.55|0.006
74019197|NCT02065453|147590565|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The data will be analyzed using linear regression, Kolmogorov-Smirnov test, and chi-square analysis.||||<0.001
74019198|NCT05523973|147590601|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
74019199|NCT05523973|147590602|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
74019200|NCT05523973|147590603|SUPERIORITY|||||||0.09|||||||Sign test|||||||0.09
74019201|NCT05523973|147590604|SUPERIORITY|||||||0.722|||||||Sign test|||||||.722
74019202|NCT05523973|147590605|SUPERIORITY|||||||0.28|||||||Sign test|||||||.28
74019203|NCT05523973|147590606|SUPERIORITY|||||||0.15|||||||Sign test|||||||.15
74019204|NCT05523973|147590607|SUPERIORITY|||||||0.8|||||||Sign test|||||||.8
74019205|NCT05523973|147590608|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
74019206|NCT05523973|147590609|SUPERIORITY|||||||0.92|||||||Sign test|||||||.92
74019207|NCT05888103|147590610|SUPERIORITY||LS Mean Difference|-47.5|||<|0.0001|TWO_SIDED|95.0|-52.35|-42.65|||ANCOVA|||||-42.65|-52.35|<0.0001
74019208|NCT05888103|147590611|SUPERIORITY||LS Mean Difference|-69.73|||<|0.0001|TWO_SIDED|95.0|-76.6|-62.86|||ANCOVA|||||-62.86|-76.60|<0.0001
74019209|NCT05888103|147590612|SUPERIORITY||LS Mean Difference|-77.83|||<|0.0001|TWO_SIDED|95.0|-85.86|-69.8|||ANCOVA|||||-69.80|-85.86|<0.0001
74019210|NCT05888103|147590613|SUPERIORITY||LS Mean Difference|-226.61|||<|0.0001|TWO_SIDED|95.0|-244.77|-208.45|||ANCOVA|||||-208.45|-244.77|<0.0001
74019211|NCT05888103|147590614|SUPERIORITY||LS Mean Difference|-31.49|||<|0.0001|TWO_SIDED|95.0|-34.91|-28.07|||ANCOVA|||||-28.07|-34.91|<0.0001
74019212|NCT05888103|147590615|SUPERIORITY||LS Mean Difference|-71.46|||<|0.0001|TWO_SIDED|95.0|-79.24|-63.69|||ANCOVA|||||-63.69|-79.24|<0.0001
74019213|NCT05888103|147590616|SUPERIORITY||LS Mean Difference|2.94||||0.3743|TWO_SIDED|95.0|-3.55|9.42|||ANCOVA|||||9.42|-3.55|0.3743
74019214|NCT05888103|147590617|SUPERIORITY||LS Mean Difference|1.07||||0.4228|TWO_SIDED|95.0|-1.54|3.68|||ANCOVA|||||3.68|-1.54|0.4228
74019215|NCT05888103|147590618|SUPERIORITY||LS Mean Difference|-40.57|||<|0.0001|TWO_SIDED|95.0|-44.57|-36.57|||ANCOVA|||||-36.57|-44.57|<0.0001
74019216|NCT05888103|147590619|SUPERIORITY||LS Mean Difference|-72.34|||<|0.0001|TWO_SIDED|95.0|-79.56|-65.13|||ANCOVA|||||-65.13|-79.56|<0.0001
74051210|NCT02815982|147655165|SUPERIORITY||Mean Difference (Final Values)|-0.12|||<|0.03|TWO_SIDED|95.0|-5.4|5.2||p \< .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores||5.2|-5.4|<.03
74051211|NCT02815982|147655166|SUPERIORITY||Mean Difference (Final Values)|3.5|||<|0.09|TWO_SIDED|95.0|-4.3|11.3||p \< .05 was threshold|t-test, 2 sided|||||11.3|-4.3|<.09
74051212|NCT02815982|147655167|SUPERIORITY||Mean Difference (Final Values)|-328.6|||<|0.08|TWO_SIDED|95.0|-2868.4|2211.2||p \< .05 threshold,|t-test, 2 sided|||We compared Post-intervention scores||2211.2|-2868.4|<.08
74051213|NCT02815982|147655168|SUPERIORITY||Mean Difference (Final Values)|0.06|||<|0.0001|TWO_SIDED|95.0|0.01|0.11||threshold set at p \< .05|t-test, 2 sided|||We compared Post-intervention scores||.11|.01|<.0001
74051214|NCT02815982|147655169|SUPERIORITY||Mean Difference (Final Values)|-2.85|||<|0.001|TWO_SIDED|95.0|-11.3|5.65||threshold set at p \< .05|t-test, 2 sided|||We compared Post-intervention scores||5.65|-11.3|<.001
74051215|NCT02815982|147655170|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.001|TWO_SIDED|95.0|-0.04|0.06||threshold p \< .05|t-test, 2 sided|||We compared Post-intervention scores||.06|-.04|<.001
74051216|NCT02815982|147655171|SUPERIORITY||Mean Difference (Final Values)|-348.9|||<|0.12|TWO_SIDED|95.0|-2762.5|2064.8||p \< .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores||2064.8|-2762.5|<.12
74019217|NCT05888103|147590620|SUPERIORITY||LS Mean Difference|-36.84|||<|0.0001|TWO_SIDED|95.0|-40.72|-32.96|||ANCOVA|||||-32.96|-40.72|<0.0001
74019218|NCT05888103|147590621|SUPERIORITY||LS Mean Difference|-41.87|||<|0.0001|TWO_SIDED|95.0|-46.28|-37.47|||ANCOVA|||||-37.47|-46.28|<0.0001
74019219|NCT05888103|147590622|SUPERIORITY||LS Mean Difference|2.05||||0.3011|TWO_SIDED|95.0|-1.84|5.93|||ANCOVA|||||5.93|-1.84|0.3011
74019220|NCT05888103|147590623|SUPERIORITY||LS Mean Difference|3.13||||0.2403|TWO_SIDED|95.0|-2.09|8.35|||ANCOVA|||||8.35|-2.09|0.2403
74019221|NCT05888103|147590624|SUPERIORITY||LS Mean Difference|-30.27|||<|0.0001|TWO_SIDED|95.0|-40.58|-19.95|||ANCOVA|||||-19.95|-40.58|<0.0001
74019222|NCT05888103|147590625|SUPERIORITY||LS Mean Difference|0.68|||<|0.0001|TWO_SIDED|95.0|0.6|0.76|||ANCOVA|||||0.76|0.60|<0.0001
74019223|NCT05888103|147590626|SUPERIORITY||LS Mean Difference|3.01||||0.5877|TWO_SIDED|95.0|-7.88|13.91|||ANCOVA|||||13.91|-7.88|0.5877
74019224|NCT05888103|147590627|SUPERIORITY||LS Mean Difference|-7.96||||0.5019|TWO_SIDED|95.0|-31.17|15.26|||ANCOVA|||||15.26|-31.17|0.5019
74019225|NCT03521791|147590650|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.133|||||||Chi-squared, Corrected|||||||0.133
74051217|NCT00702949|147655172|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.||||0.007
74051218|NCT00702949|147655175|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.||||0.002
74051219|NCT00702949|147655176|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.||||0.009
74051220|NCT00702949|147655178|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.||||0.007
74051221|NCT04491591|147655186|SUPERIORITY|||||||0.801|||||||Kruskal-Wallis|||||||0.801
74051222|NCT04491591|147655187|SUPERIORITY|||||||0.1336|||||||Fisher Exact|||Reconstruction versus No reconstruction||||0.1336
74099160|NCT00168818|147747296|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.1||||0.3173||95.0|-3.3|1.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.1|-3.3|0.3173
74051223|NCT04491591|147655187|SUPERIORITY|Immediate reconstruction versus delayed reconstruction||||||0.5505|||||||Fisher Exact|||||||0.5505
74099161|NCT00168818|147747296|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.9||||0.1274||95.0|-0.5|4.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.3|-0.5|0.1274
74099162|NCT00168818|147747297|SUPERIORITY_OR_OTHER|||||||0.0694||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0694
74099163|NCT00168818|147747297|SUPERIORITY_OR_OTHER|||||||0.0212||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0212
74099164|NCT00168818|147747298|SUPERIORITY_OR_OTHER|||||||0.5062||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.5062
74019226|NCT03521791|147590651|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
74051224|NCT04491591|147655187|SUPERIORITY|||||||0.6178|||||||Fisher Exact|||Flap reconstruction versus Implant reconstruction||||0.6178
74099165|NCT00168818|147747298|SUPERIORITY_OR_OTHER|||||||0.3717||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.3717
74099166|NCT00168818|147747299|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1240
74099167|NCT00168818|147747299|SUPERIORITY_OR_OTHER|||||||0.2497||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.2497
74099168|NCT00168818|147747301|SUPERIORITY_OR_OTHER|||||||0.4352||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4352
74099169|NCT00168818|147747301|SUPERIORITY_OR_OTHER|||||||0.6037||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6037
74019227|NCT03521791|147590652|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.333|||||||Chi-squared, Corrected|||||||0.333
74051225|NCT04491591|147655188|SUPERIORITY|||||||0.2317|||||||Fisher Exact|||||||0.2317
74051226|NCT04491591|147655189|SUPERIORITY|||||||0.1052|||||||Fisher Exact|||||||0.1052
74051227|NCT04491591|147655190|OTHER||||||||||||||||||Within subjects pre/post comparison|||
74099170|NCT00469144|147747305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||100 Days, Between Arms: Participants in CR||||0.9
74099171|NCT00469144|147747305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||100 Days, Between Arms: Participants not in CR||||0.4
74099172|NCT00469144|147747305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1 Year, Between Arms: Participants in CR||||0.7
74099173|NCT00469144|147747305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1 Year, Between Arms: Participants not in CR||||0.05
74099174|NCT01994291|147747311|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.32|STANDARD_ERROR_OF_MEAN|1.52||0.1271|TWO_SIDED|80.0|-4.27|-0.37|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.37|-4.27|0.1271
74099175|NCT01994291|147747311|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.48|STANDARD_ERROR_OF_MEAN|1.36||0.0699|TWO_SIDED|80.0|-4.24|-0.73|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.73|-4.24|0.0699
74099176|NCT01994291|147747311|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.41|STANDARD_ERROR_OF_MEAN|1.17||0.0399|TWO_SIDED|80.0|-3.91|-0.91|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.91|-3.91|0.0399
74099177|NCT01994291|147747312|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1416||||0.0218|TWO_SIDED|80.0|-0.2483|-0.0467|||Barnard test|||||-0.0467|-0.2483|0.0218
74099178|NCT01994291|147747312|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0442||||0.4209|TWO_SIDED|80.0|-0.1217|0.0261|||Barnard test.|||baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||0.0261|-0.1217|0.4209
74019228|NCT03521791|147590653|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
74019229|NCT03521791|147590654|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.394|||||||Fisher Exact|||||||0.394
74019230|NCT03521791|147590655|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.056|||||||t-test, 2 sided|||||||0.056
74019231|NCT03521791|147590657|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.114|||||||Fisher Exact|||||||0.114
74051228|NCT04491591|147655191|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
74051229|NCT04491591|147655193|OTHER||||||||||||||||||Descriptive analysis using mean and standard deviation|||
74051230|NCT04491591|147655194|SUPERIORITY|||||||0.0302|||||||Kruskal-Wallis|||||||0.0302
74051231|NCT04491591|147655195|SUPERIORITY|||||||0.135|||||||Fisher Exact|||Reconstruction versus No reconstruction||||0.135
74051232|NCT04491591|147655195|SUPERIORITY|||||||0.51|||||||Fisher Exact|||Immediate reconstruction versus delayed reconstruction||||0.510
74051233|NCT04491591|147655195|SUPERIORITY|||||||0.469|||||||Fisher Exact|||Flap reconstruction versus Implant reconstruction||||0.469
74051234|NCT04491591|147655196|SUPERIORITY|||||||0.308|||||||Fisher Exact|||||||0.308
74051235|NCT04491591|147655197|SUPERIORITY|||||||0.036|||||||Fisher Exact|||||||0.036
74051236|NCT00135694|147655198|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-13.0|||||TWO_SIDED|90.0|-35.0|10.0||||||||10|-35|
74051237|NCT00135694|147655204|SUPERIORITY_OR_OTHER|||||||0.0183|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.||||||0.0183
73881442|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1129|TWO_SIDED|95.0|0.81|7.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.61|0.81|0.1129
74099179|NCT01994291|147747312|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0849||||0.0778|TWO_SIDED|80.0|-0.1516|-0.0168|||Barnard test.|||||-0.0168|-0.1516|0.0778
74099180|NCT01994291|147747313|SUPERIORITY_OR_OTHER||Difference in LS means|114.07|STANDARD_ERROR_OF_MEAN|19.84|<|0.0001|TWO_SIDED|80.0|88.56|139.59|||Mixed Models Analysis|||||139.59|88.56|<0.0001
74099181|NCT01994291|147747313|SUPERIORITY_OR_OTHER||Difference in LS means|65.81|STANDARD_ERROR_OF_MEAN|18.36||0.0004|TWO_SIDED|80.0|42.2|89.43|||Mixed Models Analysis|||||89.43|42.20|0.0004
74019232|NCT03521791|147590658|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.117|||||||Chi-squared, Corrected|||||||0.117
74019233|NCT03521791|147590659|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.626|||||||Fisher Exact|||||||0.626
74019234|NCT04024501|147590664|OTHER||Geometric Mean ratio|106.2|||||TWO_SIDED|90.0|91.73|122.96|||Mixed Model Analysis|The number of subjects in this analysis: 22||Pairwise comparison: Treatment 2/Treatment 1||122.96|91.73|
74019235|NCT04024501|147590664|OTHER||Geometric mean ratio|50.02|||||TWO_SIDED|90.0|42.34|59.1|||Mixed Model Analysis|The number of subjects in this analysis: 22||Pairwise comparison: Treatment 3/Treatment 1||59.10|42.34|
74019236|NCT04024501|147590664|OTHER||Geometric mean ratio|47.1|||||TWO_SIDED|90.0|39.85|55.68|||Mixed Model Analysis|The number of subjects in this analysis: 15||Pairwise comparison: Treatment 3/Treatment 2||55.68|39.85|
74019237|NCT04024501|147590664|OTHER||Geometric mean ratio|58.4|||||TWO_SIDED|90.0|49.49|68.92|||Mixed Model Analysis|The number of subjects in this analysis: 15||Pairwise comparison: Treatment 3/Treatment 4||68.92|49.49|
74019238|NCT04024501|147590664|OTHER||Geometric mean ratio|85.65|||||TWO_SIDED|90.0|73.78|99.43|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 4/Treatment 1||99.43|73.78|
74019239|NCT04024501|147590664|OTHER||Geometric mean ratio|80.65|||||TWO_SIDED|90.0|69.48|93.62|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 4/Treatment 2||93.62|69.48|
74019240|NCT04024501|147590664|OTHER||Geometric mean ratio|89.88|||||TWO_SIDED|90.0|77.61|104.09|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 1||104.09|77.61|
74019241|NCT04024501|147590664|OTHER||Geometric mean ratio|84.64|||||TWO_SIDED|90.0|72.94|98.2|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 2||98.20|72.94|
74019242|NCT04024501|147590664|OTHER||Geometric mean ratio|179.68|||||TWO_SIDED|90.0|151.57|212.99|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 3||212.99|151.57|
74019243|NCT04024501|147590664|OTHER||Geometric mean ratio|104.94|||||TWO_SIDED|90.0|90.18|122.11|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 4||122.11|90.18|
74019244|NCT04024501|147590665|OTHER||Geometric mean ratio|100.39|||||TWO_SIDED|90.0|84.94|118.65|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 2/Treatment 1||118.65|84.94|
74019245|NCT04024501|147590665|OTHER||Geometric mean ratio|41.26|||||TWO_SIDED|90.0|34.74|49.0|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 1||49.00|34.74|
74019246|NCT04024501|147590665|OTHER||Geometric mean ratio|41.1|||||TWO_SIDED|90.0|34.61|48.81|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 2||48.81|34.61|
74019247|NCT04024501|147590665|OTHER||Geometric mean ratio|53.55|||||TWO_SIDED|90.0|45.09|63.59|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 4||63.59|45.09|
74019248|NCT04024501|147590665|OTHER||Geometric mean ratio|77.05|||||TWO_SIDED|90.0|65.19|91.06|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 1||91.06|65.19|
74019249|NCT04024501|147590665|OTHER||Geometric mean ratio|76.75|||||TWO_SIDED|90.0|64.94|90.71|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 2||90.71|64.94|
74019250|NCT04024501|147590665|OTHER||Geometric mean ratio|84.23|||||TWO_SIDED|90.0|70.93|100.03|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 1||100.03|70.93|
74019251|NCT04024501|147590665|OTHER||Geometric mean ratio|83.9|||||TWO_SIDED|90.0|70.65|99.64|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 2||99.64|70.65|
74019252|NCT04024501|147590665|OTHER||Geometric mean ratio|204.16|||||TWO_SIDED|90.0|171.22|243.42|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 3||243.42|171.22|
74019253|NCT04024501|147590665|OTHER||Geometric mean ratio|109.32|||||TWO_SIDED|90.0|92.06|129.83|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 4||129.83|92.06|
74019254|NCT04024501|147590666|OTHER||Geometric mean ratio|124.99|||||TWO_SIDED|90.0|101.09|154.54|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 2/Treatment 1||154.54|101.09|
74019255|NCT04024501|147590666|OTHER||Geometric mean ratio|33.77|||||TWO_SIDED|90.0|27.15|42.01|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 1||42.01|27.15|
74019256|NCT04024501|147590666|OTHER||Geometric mean ratio|27.02|||||TWO_SIDED|90.0|21.72|33.61|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 2||33.61|21.72|
74019257|NCT04024501|147590666|OTHER||Geometric mean ratio|36.84|||||TWO_SIDED|90.0|29.61|45.82|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 4||45.82|29.61|
74019258|NCT04024501|147590666|OTHER||Geometric mean ratio|91.69|||||TWO_SIDED|90.0|74.15|113.36|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 1||113.36|74.15|
74019259|NCT04024501|147590666|OTHER||Geometric mean ratio|73.36|||||TWO_SIDED|90.0|59.33|90.7|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 2||90.70|59.33|
74019260|NCT04024501|147590666|OTHER||Geometric mean ratio|67.62|||||TWO_SIDED|90.0|54.37|84.12|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 1||84.12|54.37|
74019261|NCT04024501|147590666|OTHER||Geometric mean ratio|54.11|||||TWO_SIDED|90.0|43.5|67.3|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 2||67.30|43.50|
74019262|NCT04024501|147590666|OTHER||Geometric mean ratio|200.23|||||TWO_SIDED|90.0|160.15|250.32|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 3||250.32|160.15|
74051238|NCT00135694|147655205|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.||||||<0.0001
74051239|NCT00472043|147655206|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||||<0.001
74051240|NCT00852761|147655229|SUPERIORITY_OR_OTHER|||||||0.7298||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.7298
74051241|NCT00852761|147655229|SUPERIORITY_OR_OTHER|||||||1||||||This is the result for the Day 8 analysis.|Chi-squared|||||||1.0000
74051242|NCT00852761|147655230|SUPERIORITY_OR_OTHER|||||||0.7298||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.7298
74099182|NCT01994291|147747313|SUPERIORITY_OR_OTHER||Difference in LS means|87.32|STANDARD_ERROR_OF_MEAN|15.44|<|0.0001|TWO_SIDED|80.0|67.45|107.19|||Mixed Models Analysis|||||107.19|67.45|<0.0001
74019263|NCT04024501|147590666|OTHER||Geometric mean ratio|73.76|||||TWO_SIDED|90.0|59.3|91.75|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 4||91.75|59.30|
74019264|NCT00680836|147590676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.26|TWO_SIDED|95.0|-1.0|0.3|||t-test, 2 sided|||||0.3|-1.0|0.26
74019265|NCT00680836|147590677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.98|TWO_SIDED|95.0|0.0|0.5|||t-test, 2 sided|||||0.5|0.0|0.98
74019266|NCT00680836|147590678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.78
74019267|NCT00680836|147590679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.64|TWO_SIDED|95.0|-0.2|0.2|||Chi-squared|||||0.2|-0.2|0.64
74019268|NCT00680836|147590680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.72|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||||0.5|-0.7|0.72
74019269|NCT00680836|147590681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.86|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||||0.6|-0.5|0.86
74019270|NCT03242954|147590718|SUPERIORITY||Cohen's f square|0.011|STANDARD_ERROR_OF_MEAN|0.208||0.5148|TWO_SIDED|95.0|0.001|0.101|||Regression, Linear|||||0.101|0.001|0.5148
74019271|NCT03242954|147590719|SUPERIORITY||Cohen's f square|0.306|STANDARD_ERROR_OF_MEAN|0.149|<|0.0001|TWO_SIDED|95.0|0.169|0.389|||Regression, Linear|||||0.389|0.169|<.0001
74019272|NCT03242954|147590720|SUPERIORITY||Cohen's f square|0.008|STANDARD_ERROR_OF_MEAN|0.213||0.4324|TWO_SIDED|95.0|0.001|0.073|||GEE Linear model|||||0.073|0.001|0.4324
74019273|NCT03242954|147590721|SUPERIORITY||Cohen's f square|0.26|STANDARD_ERROR_OF_MEAN|0.149|<|0.0001|TWO_SIDED|95.0|0.175|0.374|||GEE Linear model|||||0.374|0.175|<.0001
74019274|NCT05512949|147590723|NON_INFERIORITY|The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).|Geometric mean titer ratio (GMTR)|0.7||||0.045|TWO_SIDED|95.0|0.5|1.0||Significance can be considered if P \<0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.||The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.||1.0|0.5|0.045
74019275|NCT05512949|147590723|NON_INFERIORITY|The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).|Geometric mean titer ratio (GMTR)|0.4||||0.162|TWO_SIDED|95.0|0.3|0.6||Significance can be considered if P \<0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.||The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.||0.6|0.3|0.162
74019276|NCT05512949|147590726|SUPERIORITY|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.888
74019277|NCT05512949|147590726|SUPERIORITY|||||||0.708|||||||Wilcoxon (Mann-Whitney)|||||||0.708
74019278|NCT00559273|147590787|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.||||<0.0001
74019279|NCT00559273|147590787|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.||||<0.0001
74051243|NCT00852761|147655230|SUPERIORITY_OR_OTHER|||||||0.006||||||This is the result for the Day 8 analysis.|Chi-squared|||||||0.0060
74051244|NCT00852761|147655230|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||This is the result for the Day 15 analysis.|Chi-squared|||||||0.0060
74051245|NCT00852761|147655231|SUPERIORITY_OR_OTHER|||||||0.0332||||||Data apply to Day 15.|Chi-squared|||||||0.0332
74051246|NCT00852761|147655233|SUPERIORITY_OR_OTHER|||||||0.3101||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.3101
74051247|NCT00852761|147655233|SUPERIORITY_OR_OTHER|||||||0.7242||95.0||||This is the result for the Day 8 analysis.|Chi-squared|||||||0.7242
74051248|NCT00852761|147655233|SUPERIORITY_OR_OTHER|||||||0.0135||||||This is the p value for day 15|Chi-squared|||||||0.0135
74051249|NCT00852761|147655235|SUPERIORITY_OR_OTHER|||||||0.1449||||||P value at day 15.|Chi-squared|||||||0.1449
74051250|NCT00852761|147655235|SUPERIORITY_OR_OTHER|||||||0.1634||||||P value at day 3.|Chi-squared|||||||0.1634
74051251|NCT00852761|147655235|SUPERIORITY_OR_OTHER|||||||0.5454||||||P value at day 8.|Chi-squared|||||||0.5454
74051252|NCT00852761|147655236|SUPERIORITY_OR_OTHER|||||||0.6715||||||This is the p value for day 15.|Chi-squared|||||||0.6715
74051253|NCT00852761|147655236|SUPERIORITY_OR_OTHER|||||||0.7242||||||This is the p value for day 8.|Chi-squared|||||||0.7242
74051254|NCT00852761|147655236|SUPERIORITY_OR_OTHER|||||||0.6715||||||This is the p value for day 3.|Chi-squared|||||||0.6715
74051255|NCT00852761|147655237|SUPERIORITY_OR_OTHER|||||||0.4858||||||P value on day 8.|Chi-squared|||||||0.4858
74051256|NCT00852761|147655237|SUPERIORITY_OR_OTHER|||||||0.3001||||||P value on day 15.|Chi-squared|||||||0.3001
74051257|NCT00877890|147655253|NON_INFERIORITY_OR_EQUIVALENCE|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide once weekly and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|95.0|-0.94|-0.39|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors.||Superiority of exenatide once weekly to BYETTA if the upper limit of the 2-sided 95% CI for treatment difference (exenatide once weekly minus BYETTA) is \<0; noninferiority if this upper limit is \<0.4%. Power: Assuming 15% dropout rate with 206 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in exenatide once weekly and a common standard deviation of 1.1%.||-0.39|-0.94|<.0001
74051258|NCT00877890|147655254|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of \<7% at Week 24 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||<.0001
74051259|NCT00877890|147655255|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||<.0001
74051260|NCT00877890|147655256|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|5.57||0.0006|TWO_SIDED|95.0|-31.4|-9.5||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.||-9.5|-31.4|0.0006
74051261|NCT00877890|147655257|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving fasting plasma glucose target of \<=126 mg/dL at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving fasting plasma glucose target. Power: based on the primary measurement.||||0.0008
74051262|NCT00877890|147655258|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.487||0.0514|TWO_SIDED|95.0|-1.91|0.01|||ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.||0.01|-1.91|0.0514
74051263|NCT00877890|147655259|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.5||0.2367|TWO_SIDED|95.0|-4.7|1.2|||ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the systolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline systolic blood pressure. Power: based on the primary measurement.||1.2|-4.7|0.2367
74051264|NCT00877890|147655260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7717|TWO_SIDED|95.0|-1.7|2.2|||ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the diastolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline diastolic blood pressure. Power: based on the primary measurement.||2.2|-1.7|0.7717
74051265|NCT00877890|147655261|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001|TWO_SIDED|95.0|-22.9|-9.1|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.||-9.1|-22.9|<.0001
74051266|NCT00877890|147655262|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.8||0.1251|TWO_SIDED|95.0|-2.8|0.3|||ANCOVA|||Analysis: Change in HDL from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.||0.3|-2.8|0.1251
74051267|NCT00877890|147655263|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.043||0.2558|TWO_SIDED|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day 1) , expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.||1.04|0.87|0.2558
74051268|NCT00498706|147655300|SUPERIORITY_OR_OTHER||t value|-2.95||||0.003||95.0|||||t-test, 2 sided|||||||0.003
74051269|NCT00498706|147655301|SUPERIORITY_OR_OTHER||Chi-square|5.83||||0.02||95.0|||||Chi-squared|||||||0.02
74099183|NCT01994291|147747314|SUPERIORITY_OR_OTHER||Difference in LS means|7.98|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|80.0|6.13|9.83|||ANCOVA|||||9.83|6.13|<0.0001
74099184|NCT01994291|147747314|SUPERIORITY_OR_OTHER||Difference in LS means|6.34|STANDARD_ERROR_OF_MEAN|1.28|<|0.0001|TWO_SIDED|80.0|4.7|7.98|||ANCOVA|||||7.98|4.70|<0.0001
74099185|NCT01994291|147747314|SUPERIORITY_OR_OTHER||Difference in LS means|7.07|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|80.0|5.66|8.48|||ANCOVA|||||8.48|5.66|<0.0001
74099186|NCT01994291|147747315|SUPERIORITY_OR_OTHER||Difference in LS means|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.0423|TWO_SIDED|80.0|0.13|0.55|||ANCOVA|||||0.55|0.13|0.0423
74099187|NCT01994291|147747315|SUPERIORITY_OR_OTHER||Difference in LS means|0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|80.0|0.36|0.75|||ANCOVA|||||0.75|0.36|0.0004
74099188|NCT01994291|147747315|SUPERIORITY_OR_OTHER||Difference in LS means|0.46|STANDARD_ERROR_OF_MEAN|0.13||0.0004|TWO_SIDED|80.0|0.3|0.63|||ANCOVA|||||0.63|0.30|0.0004
74051270|NCT00498706|147655301|SUPERIORITY_OR_OTHER||Chi-square|7.75||||0.006||95.0|||||Chi-squared||Attrition before week 5 was significantly lower in T-CBT than in face-to-face CBT.|||||.006
74099189|NCT01775189|147747324|SUPERIORITY_OR_OTHER||Least Squares (LS) mean Difference|9.5||||0.0001|TWO_SIDED|95.0|4.8|14.2||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.2|4.8|0.0001
74099190|NCT01775189|147747324|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|95.0|-37.0|-27.6||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-27.6|-37.0|<0.0001
74099191|NCT01775189|147747324|SUPERIORITY_OR_OTHER||LS Mean Difference|9.1||||0.0002|TWO_SIDED|95.0|4.5|13.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.8|4.5|0.0002
74051271|NCT00498706|147655303|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|-0.09|STANDARD_DEVIATION|1.26||0.89|TWO_SIDED|95.0|-1.35|1.17|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.||1.17|-1.35|0.89
74099192|NCT01775189|147747324|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.8806|TWO_SIDED|95.0|-5.0|4.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.3|-5.0|0.8806
74099193|NCT01775189|147747324|SUPERIORITY_OR_OTHER||LS Mean Difference|41.4|||<|0.0001|TWO_SIDED|95.0|36.8|46.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.1|36.8|<0.0001
74099194|NCT01775189|147747324|SUPERIORITY_OR_OTHER||LS Mean Difference|41.8|||<|0.0001|TWO_SIDED|95.0|37.1|46.4||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.4|37.1|<0.0001
74099195|NCT01775189|147747325|SUPERIORITY_OR_OTHER||LS Mean Difference|6.6||||0.2176|TWO_SIDED|95.0|-4.0|17.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.1|-4.0|0.2176
74099196|NCT01775189|147747325|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.6|||<|0.0001|TWO_SIDED|95.0|-65.1|-44.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-44.1|-65.1|<0.0001
74099197|NCT01775189|147747325|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0||||0.3502|TWO_SIDED|95.0|-5.6|15.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.5|-5.6|0.3502
74099198|NCT01775189|147747325|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.7624|TWO_SIDED|95.0|-12.1|8.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.9|-12.1|0.7624
74099199|NCT01775189|147747325|SUPERIORITY_OR_OTHER||LS Mean Difference|59.6|||<|0.0001|TWO_SIDED|95.0|49.0|70.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||70.1|49.0|<0.0001
74099200|NCT01775189|147747325|SUPERIORITY_OR_OTHER||LS Mean Difference|61.2|||<|0.0001|TWO_SIDED|95.0|50.6|71.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.7|50.6|<0.0001
74099201|NCT01775189|147747326|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.0001|TWO_SIDED|95.0|13.8|35.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.3|13.8|<0.0001
74099202|NCT01775189|147747326|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.7|||<|0.0001|TWO_SIDED|95.0|-72.6|-50.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-50.9|-72.6|<0.0001
74099203|NCT01775189|147747326|SUPERIORITY_OR_OTHER||LS Mean Difference|18.2||||0.0012|TWO_SIDED|95.0|7.4|29.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.1|7.4|0.0012
74099204|NCT01775189|147747326|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.2507|TWO_SIDED|95.0|-17.2|4.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.5|-17.2|0.2507
74099205|NCT01775189|147747326|SUPERIORITY_OR_OTHER||LS Mean Difference|79.9|||<|0.0001|TWO_SIDED|95.0|69.2|90.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.7|69.2|<0.0001
74099206|NCT01775189|147747326|SUPERIORITY_OR_OTHER||LS Mean Difference|86.3|||<|0.0001|TWO_SIDED|95.0|75.4|97.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||97.1|75.4|<0.0001
74099207|NCT01775189|147747327|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.0015|TWO_SIDED|95.0|10.6|43.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.1|10.6|0.0015
74099208|NCT01775189|147747327|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.3|||<|0.0001|TWO_SIDED|95.0|-125.7|-93.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-93.0|-125.7|<0.0001
74099209|NCT01775189|147747327|SUPERIORITY_OR_OTHER||LS Mean Difference|21.4||||0.0109|TWO_SIDED|95.0|5.1|37.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.8|5.1|0.0109
74099210|NCT01775189|147747327|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.4||||0.5117|TWO_SIDED|95.0|-21.8|10.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.9|-21.8|0.5117
74099211|NCT01775189|147747327|SUPERIORITY_OR_OTHER||LS Mean Difference|130.8|||<|0.0001|TWO_SIDED|95.0|114.5|147.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||147.0|114.5|<0.0001
74099212|NCT01775189|147747327|SUPERIORITY_OR_OTHER||LS Mean Difference|136.2|||<|0.0001|TWO_SIDED|95.0|119.8|152.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||152.5|119.8|<0.0001
74099213|NCT00856375|147747382|OTHER|Hazard Ratio and 95% CI from univariate Cox regression model|Hazard Ratio (HR)|0.645|||=|0.07|TWO_SIDED|95.0|0.4|1.041|||Log Rank|||||1.041|0.4|= 0.07
74099214|NCT00856375|147747383|OTHER|Hazard ratio and 95% CI from univariate Cox regression model.|Hazard Ratio (HR)|0.91|||=|0.706|TWO_SIDED|95.0|0.557|1.486|||Log Rank|||||1.486|0.557|= 0.706
74099215|NCT00856375|147747384|OTHER|ORR 95% CI based on Exact (Clopper-Pearson) confidence limits. Odds ratio 95% CI based on asymptotic confidence limits.|Odds Ratio (OR)|2.054|||=|0.676|TWO_SIDED|95.0|0.355|11.9|||Fisher Exact|||||11.9|0.355|= 0.676
74099216|NCT00856375|147747385|SUPERIORITY||||||=|0.018|||||||Log Rank|||||||= 0.018
74099217|NCT02597127|147747408|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
74099218|NCT02597127|147747408|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
74019280|NCT00559273|147590788|NON_INFERIORITY_OR_EQUIVALENCE|MIRCERA treatment was regarded as non-inferior to the darbepoetin alfa reference group if the lower limit of the CI was greater than -0.75 g/dL.|Adjusted Mean Difference|-0.036|STANDARD_ERROR_OF_MEAN|0.1097|<|0.0001|TWO_SIDED|95.0|-0.252|0.18|||ANCOVA|||||0.180|-0.252|<0.0001
74019281|NCT03213366|147590857|SUPERIORITY||Slope|-0.0095||||0.5783|TWO_SIDED|95.0|-0.04676|0.02776|||Mixed Models Analysis|||At 6 weeks.||0.02776|-0.04676|0.5783
74019282|NCT03213366|147590857|SUPERIORITY||Slope|-0.01692||||0.3185|TWO_SIDED|95.0|-0.05318|0.01933|||Mixed Models Analysis|||At 12 weeks.||0.01933|-0.05318|0.3185
74019283|NCT03213366|147590858|SUPERIORITY||Slope|0.03674||||0.07863|TWO_SIDED|95.0|-0.00516|0.07863|||Mixed Models Analysis|||At 6 weeks.||0.07863|-0.00516|0.07863
74019284|NCT03213366|147590858|SUPERIORITY||Slope|0.02594||||0.1999|TWO_SIDED|95.0|-0.01648|0.06836|||Mixed Models Analysis|||At 12 weeks.||0.06836|-0.01648|0.1999
74051272|NCT00498706|147655304|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|1.07|STANDARD_DEVIATION|1.695||0.22|TWO_SIDED|95.0|-0.63|2.76|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.||2.76|-0.63|0.22
74051273|NCT01005966|147655322|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.01||||0.2117|TWO_SIDED|95.0|-7.75|1.73||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|Analysis of variance (ANOVA) based on a mixed model with the factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for NaF toothpaste and AmF toothpaste to be equal with respect to enamel remineralization potential.||1.73|-7.75|0.2117
74051274|NCT01005966|147655323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.96||||0.0002|TWO_SIDED|95.0|4.27|13.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||13.66|4.27|0.0002
74051275|NCT01005966|147655323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.57||||0.0557||95.0|-0.11|9.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.||9.24|-0.11|0.0557
74051276|NCT01005966|147655323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.55|||<|0.0001|TWO_SIDED|95.0|18.86|28.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||28.24|18.86|<0.0001
74051277|NCT01005966|147655323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.4||||0.0625|TWO_SIDED|95.0|-0.23|9.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||9.03|-0.23|0.0625
74051278|NCT01005966|147655323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|18.99|||<|0.0001|TWO_SIDED|95.0|14.36|23.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||23.61|14.36|<0.0001
74051279|NCT01005966|147655323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.59|||<|0.0001|TWO_SIDED|95.0|9.95|19.23||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||19.23|9.95|<0.0001
74051280|NCT01005966|147655323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.58||||0.0017|TWO_SIDED|95.0|2.88|12.27||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the AmF toothpaste (1400ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.||12.27|2.88|0.0017
74051281|NCT01005966|147655323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.97|||<|0.0001|TWO_SIDED|95.0|7.31|16.64||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||16.64|7.31|<0.0001
73881443|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0432|TWO_SIDED|95.0|1.04|10.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.37|1.04|0.0432
73881444|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0315|TWO_SIDED|95.0|1.13|12.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.60|1.13|0.0315
73881445|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|4.26||||0.0147|TWO_SIDED|95.0|1.33|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.64|1.33|0.0147
73881446|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0405|TWO_SIDED|95.0|1.05|9.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.59|1.05|0.0405
73881447|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5238|TWO_SIDED|95.0|0.5|3.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.93|0.50|0.5238
73881448|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.73||||0.306|TWO_SIDED|95.0|0.6|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.97|0.60|0.3060
73881449|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.64||||0.3747|TWO_SIDED|95.0|0.55|4.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.86|0.55|0.3747
74099219|NCT02597127|147747408|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 500 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
74099220|NCT02597127|147747408|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 100 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
74099221|NCT02597127|147747408|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
74099222|NCT02597127|147747408|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
74099223|NCT02922738|147747418|SUPERIORITY||Cox Proportional Hazard|0.92||||0.54|TWO_SIDED|95.0|0.7|1.21|||Regression, Cox|||||1.21|0.70|0.54
73881450|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.49||||0.0443|TWO_SIDED|95.0|1.03|11.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.80|1.03|0.0443
73881451|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.49||||0.1269|TWO_SIDED|95.0|0.77|8.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.06|0.77|0.1269
73881452|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|5.15||||0.0095|TWO_SIDED|95.0|1.49|17.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.13|1.49|0.0095
73881453|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1254|TWO_SIDED|95.0|0.79|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.94|0.79|0.1254
73881454|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0402|TWO_SIDED|95.0|1.06|12.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.63|1.06|0.0402
73881455|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4547|TWO_SIDED|95.0|0.47|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.42|0.47|0.4547
73881456|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4008|TWO_SIDED|95.0|0.49|5.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.99|0.49|0.4008
74099224|NCT02922738|147747419|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
74051282|NCT01005966|147655323|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|26.56|||<|0.0001|TWO_SIDED|95.0|21.88|31.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||31.24|21.88|<0.0001
74051283|NCT01005966|147655324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.24||||0.7912|TWO_SIDED|95.0|-239.62|314.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and AmF toothpaste (1400ppmF) to be equal with respect to enamel fluoride uptake potential.||314.09|-239.62|0.7912
74051284|NCT01005966|147655324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|532.61||||0.0002|TWO_SIDED|95.0|259.06|806.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel fluoride uptake potential.||806.16|259.06|0.0002
74051285|NCT01005966|147655324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|692.91|||<|0.0001|TWO_SIDED|95.0|418.73|967.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||967.09|418.73|<0.0001
74051286|NCT01005966|147655324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1879.4|||<|0.0001|TWO_SIDED|95.0|1605.75|2153.04||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||2153.04|1605.75|<0.0001
74051287|NCT01005966|147655324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|495.38||||0.0005|TWO_SIDED|95.0|221.09|769.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and Na MFP/ NaF toothpaste (1450ppmF) and to be equal with respect to enamel fluoride uptake potential.||769.66|221.09|0.0005
74051288|NCT01005966|147655324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|655.67|||<|0.0001|TWO_SIDED|95.0|382.41|928.93||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||928.93|382.41|<0.0001
74099225|NCT00811928|147747420|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the 95% Confidence Interval for the difference in incidence defined as (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100% (posaconazole minus fluconazole) had to be \< 4 in order to be considered non-inferior. IFI occurred: proven+probable|Difference for the incidence|-5.88|||||TWO_SIDED|95.0|-12.21|0.25|||||Posaconazole minus fluconazole|||0.25|-12.21|
74099226|NCT00811928|147747421|SUPERIORITY_OR_OTHER||Percentage of Participants|4.27|||||TWO_SIDED|95.0|1.4|9.7|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||9.7|1.4|
74099227|NCT00811928|147747421|SUPERIORITY_OR_OTHER||Percentage of Participants|13.68|||||TWO_SIDED|95.0|8.0|21.3|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||21.3|8.0|
73881457|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1535|TWO_SIDED|95.0|0.71|9.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.22|0.71|0.1535
74099228|NCT00811928|147747424|SUPERIORITY_OR_OTHER||Percentage of Participants|31.62|||||TWO_SIDED|95.0|23.3|40.9|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%.|||40.9|23.3|
74099229|NCT00811928|147747424|SUPERIORITY_OR_OTHER||Percentage of Participants|41.88|||||TWO_SIDED|95.0|32.8|51.4|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||51.4|32.8|
74099230|NCT00811928|147747425|SUPERIORITY_OR_OTHER||Percentage of Participants|2.56|||||TWO_SIDED|95.0|0.5|7.3|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.|||7.3|0.5|
74099231|NCT00811928|147747425|SUPERIORITY_OR_OTHER||Percentage of Participants|5.98|||||TWO_SIDED|95.0|2.4|11.9|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.|||11.9|2.4|
73881458|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0055|TWO_SIDED|95.0|1.79|28.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||28.95|1.79|0.0055
74099232|NCT03203564|147747443|OTHER||Mean Difference (Final Values)|7.4|||||TWO_SIDED|90.0|0.68|14.12|||||Parameter estimate is done for Placebo-corrected change-from baseline QTcF (ΔΔQTcF) for Modufolin 500 mg/m2 at end of infusion.|"The primary analysis of QTcF was based on a linear mixed-effects model with change-from-baseline QTcF as the dependent variable, time (categorical), treatment, and time-by-treatment interaction as fixed effects, and baseline QTcF as a covariate. The least-squares (LS) mean and 2-sided 90 % CIs have been calculated for the contrast Modufolin® versus placebo at each dose of Modufolin® and each post-dose time point."||14.12|0.68|
74019285|NCT03213366|147590859|SUPERIORITY||Slope|0.000443||||0.8963|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.8963
74019286|NCT03213366|147590859|SUPERIORITY||Slope|0.004308||||0.3229|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks||||0.3229
74019287|NCT03213366|147590860|SUPERIORITY||Slope|0.008705||||0.2433|TWO_SIDED|||||This t-test was for the random effects model not for comparing the difference between the arms.|Mixed Models Analysis|||||||0.2433
74019288|NCT03213366|147590860|SUPERIORITY||Slope|0.01358||||0.0839|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0839
74019289|NCT03213366|147590861|SUPERIORITY||Slope|-0.302||||0.2114|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.2114
74019290|NCT03213366|147590861|SUPERIORITY||Slope|-0.03149||||0.2141|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.2141
74019291|NCT03213366|147590862|SUPERIORITY||Slope|0.0278||||0.0124|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.0124
74019292|NCT03213366|147590862|SUPERIORITY||Slope|0.03052||||0.0022|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0022
74019293|NCT03213366|147590863|SUPERIORITY||Slope|-0.05747||||0.1021|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.1021
74019294|NCT03213366|147590863|SUPERIORITY||Slope|-0.05101||||0.133|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.133
74019295|NCT03213366|147590864|SUPERIORITY||Slope|-0.0209||||0.0818|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.0818
74019296|NCT03213366|147590864|SUPERIORITY||Slope|0.03103||||0.0334|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0334
74019297|NCT02532855|147590868|NON_INFERIORITY|For the primary hypothesis, sitagliptin will be considered non-inferior to dapagliflozin if the upper bound of the two-sided 95% confidence interval (CI) of the between-group difference in least squares mean change from baseline in A1C (sitagliptin minus dapagliflozin) is less than 0.3% (the non-inferiority margin). Longitudinal data analysis (LDA), Antihyperglycemic agent (AHA), Least squares means (LSM)|Difference in LSM (Sit. - Dap.)|-0.15|||||TWO_SIDED|95.0|-0.26|-0.04||||LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||-0.04|-0.26|
74019298|NCT02532855|147590868|SUPERIORITY||Difference in LSM (Sit. - Dap.)|-0.15||||0.006|TWO_SIDED|95.0|-0.26|-0.04|||Longitudinal data analysis|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||-0.04|-0.26|0.006
74019299|NCT02532855|147590869|OTHER||Difference in % (Sit. - Dap.)|-2.8|||||TWO_SIDED|95.0|-10.7|5.1||||Miettinen \& Nurminen method||||5.1|-10.7|
74019300|NCT02532855|147590870|OTHER||Difference in % (Sit. - Dap.)|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||Miettinen \& Nurminen method||||3.0|-3.0|
74019301|NCT02532855|147590871|SUPERIORITY||Difference in LSM (Sit. - Dap.)|-5.7||||0.138|TWO_SIDED|95.0|-13.3|1.8|||LDA|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||1.8|-13.3|0.138
74019302|NCT02532855|147590872|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|-3.4|||||TWO_SIDED|95.0|-12.1|5.3||||The ANCOVA model included terms for treatment, background AHA, and the baseline 2-hour PPG value as a covariate.||||5.3|-12.1|
74019303|NCT02532855|147590873|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|-4.4|||||TWO_SIDED|95.0|-10.1|1.4||||The ANCOVA model included terms for treatment, background AHA, and the baseline glucagon AUC value as a covariate.||||1.4|-10.1|
74019304|NCT02532855|147590874|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|4.9|||||TWO_SIDED|95.0|-12.2|22.0||||The ANCOVA model included terms for treatment, background AHA, and the baseline insulin AUC value as a covariate.||||22.0|-12.2|
74019305|NCT02532855|147590875|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|0.6|||||TWO_SIDED|95.0|-0.1|1.3||||The ANCOVA model included terms for treatment, background AHA, and the baseline insulin AUC to glucagon AUC ratio value as a covariate.||||1.3|-0.1|
74019306|NCT02532855|147590876|OTHER|The percentage of participants was estimated using standard multiple imputation techniques from LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.|Difference in % (Sit. - Dap.)|15.5|||||TWO_SIDED|95.0|7.7|23.2||||Miettinen and Nurminen (M\&N) method with multiple imputation from a LDA Model.||||23.2|7.7|
74019307|NCT02532855|147590877|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|3.5|||||TWO_SIDED|95.0|-1.2|8.3||||LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||8.3|-1.2|
74019308|NCT01727258|147590878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.85|STANDARD_ERROR_OF_MEAN|1.72|<|0.001|TWO_SIDED|95.0|7.45|14.25||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Colgate Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||14.25|7.45|<0.001
74019309|NCT01727258|147590878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|1.729||0.314|TWO_SIDED|95.0|-5.16|1.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.67|-5.16|0.314
74099233|NCT03496610|147747480|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed given non-normal distribution of data by Shapiro Wilks Test. Null hypothesis is that there is no difference in oral morphine equivalent consumption between the two groups in the first 24hrs after surgery. Original sample size calculation based on α=0.05, β=0.8, difference in means=2, and effect size of 1.0.||||0.81
74099234|NCT03496610|147747481|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference between the two groups in pain on postoperative day 7.||||0.40
74099235|NCT03496610|147747482|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference in bloating severity between the two groups.||||0.74
74051289|NCT01005966|147655324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1842.16|||<|0.0001|TWO_SIDED|95.0|1568.73|2115.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||2115.60|1568.73|<0.0001
74051290|NCT01005966|147655324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|160.3||||0.2448|TWO_SIDED|95.0|-110.58|431.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||431.18|-110.58|0.2448
74051291|NCT01005966|147655324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1346.79|||<|0.0001|TWO_SIDED|95.0|1076.46|1617.11||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||1617.11|1076.46|<0.0001
74051292|NCT01005966|147655324|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1186.49|||<|0.0001|TWO_SIDED|95.0|915.38|1457.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||1457.60|915.38|<0.0001
74051293|NCT01451203|147655325|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann point estimate of shift|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0||The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.|ANCOVA|||The mTSS was analyzed using LINEAR for the imputation of missing data at Week 52.The primary Week 52 analysis assessed whether treatment up to Week 52 with the CZP group was superior to the placebo group in mTSS at Week 52. The 2-sided null and alternative hypotheses were: H0: πC = πM Ha: πC ≠ πM where πC represented subjects in the CZP group at Week 52 and πM represented subjects in the placebo group at Week 52.||0.00|0.00|<0.001
74051294|NCT01451203|147655326|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman point estimate of shift|0.0||||0.003|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.||The mTSS was analyzed using LINEAR for the imputation of missing data at Week 24.||0.00|0.00|0.003
74051295|NCT01451203|147655327|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
74051296|NCT01451203|147655328|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
74051297|NCT01451203|147655329|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Fisher Exact|||||||0.002
74051298|NCT01038635|147655363|SUPERIORITY_OR_OTHER||Maximal tolerated dose|75.0|||||TWO_SIDED||||||||Maximal tolerated dose not reached as no dose limiting toxicity documented. MTD considered to be last dose level.|||||
74051299|NCT03018340|147655403|SUPERIORITY||Difference in weighted MMRM LSMs|-1.7|STANDARD_ERROR_OF_MEAN|0.85||0.039|TWO_SIDED|95.0|-3.4|-0.1|||Mixed Models Analysis|||This is the primary statistical comparison for Stage 1 and Stage 2 combined.||-0.1|-3.4|0.0390
74099236|NCT03496610|147747483|OTHER|||||||0.38|||||||Chi-squared|Degrees of freedom = 1||Compared using the Likelihood ratio test with α=0.05. The null hypothesis was that there is no difference between the groups.||||0.38
74099237|NCT01727726|147747484|OTHER||Mean Difference (Final Values)|-1.48||||0.0078|TWO_SIDED|95.0|-2.56|-0.39|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)||||-0.39|-2.56|0.0078
74099238|NCT01727726|147747484|OTHER||Mean Difference (Final Values)|-0.3||||0.6642|TWO_SIDED|95.0|-1.63|1.04|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)||||1.04|-1.63|0.6642
74099239|NCT01727726|147747485|OTHER||Mean Difference (Final Values)|-0.23||||0.1334|TWO_SIDED|95.0|-0.52|0.07|||MMRM|Mixed-model repeated measures (MMRM)||||0.07|-0.52|0.1334
74099240|NCT01727726|147747485|OTHER||Mean Difference (Final Values)|0.42||||0.0237|TWO_SIDED|95.0|0.06|0.78|||MMRM|Mixed-model repeated measures (MMRM)||||0.78|0.06|0.0237
74099241|NCT01727726|147747486|OTHER||Mean Difference (Final Values)|-1.53||||0.0001|TWO_SIDED|95.0|-2.29|-0.76|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 2||-0.76|-2.29|0.0001
74099242|NCT01727726|147747486|OTHER||Mean Difference (Final Values)|-1.22||||0.0103|TWO_SIDED|95.0|-2.15|-0.29|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 2||-0.29|-2.15|0.0103
74099243|NCT01727726|147747486|OTHER||Mean Difference (Final Values)|-1.17||||0.0185|TWO_SIDED|95.0|-2.15|-0.2|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 4||-0.20|-2.15|0.0185
74099244|NCT01727726|147747486|OTHER||Mean Difference (Final Values)|-0.08||||0.8949|TWO_SIDED|95.0|-1.27|1.11|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 4||1.11|-1.27|0.8949
74099245|NCT01727726|147747487|OTHER||Mean Difference (Final Values)|-0.15||||0.035|TWO_SIDED|95.0|-0.29|-0.01|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score||-0.01|-0.29|0.0350
74099246|NCT01727726|147747487|OTHER||Mean Difference (Final Values)|-0.05||||0.5601|TWO_SIDED|95.0|-0.22|0.12|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score||0.12|-0.22|0.5601
74099247|NCT01727726|147747487|OTHER||Mean Difference (Final Values)|-0.19||||0.0146|TWO_SIDED|95.0|-0.35|-0.04|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score||-0.04|-0.35|0.0146
74099248|NCT01727726|147747487|OTHER||Mean Difference (Final Values)|-0.04||||0.7127|TWO_SIDED|95.0|-0.23|0.15|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score||0.15|-0.23|0.7127
74099249|NCT01727726|147747488|OTHER||Ratio of response rate|1.49||||0.2242|TWO_SIDED|95.0|0.78|2.84|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.84|0.78|0.2242
74099250|NCT01727726|147747488|OTHER||Ratio of Response Rate|1.26||||0.5998|TWO_SIDED|95.0|0.53|2.98|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.98|0.53|0.5998
74099251|NCT01727726|147747489|OTHER||Ratio of Response Rate|1.52||||0.3321|TWO_SIDED|95.0|0.66|3.49|||Cochran-Mantel-Haenszel|||Phase B Week 6||3.49|0.66|0.3321
74099252|NCT01727726|147747489|OTHER||Ratio of Response Rate|0.51||||0.3917|TWO_SIDED|95.0|0.11|2.46|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.46|0.11|0.3917
74099253|NCT01727726|147747490|OTHER||Ratio of Response Rate|1.35||||0.0032|TWO_SIDED|95.0|1.1|1.66|||Cochran-Mantel-Haenszel|||Phase B Week 6||1.66|1.10|0.0032
74099254|NCT01727726|147747490|OTHER||Ratio of Response Rate|1.24||||0.0898|TWO_SIDED|95.0|0.98|1.59|||Cochran-Mantel-Haenszel|||Phase B Week 6||1.59|0.98|0.0898
74099255|NCT01727726|147747492|OTHER||Mean Difference (Final Values)|0.16||||0.448|TWO_SIDED|95.0|-0.25|0.56|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score||0.56|-0.25|0.4480
74099256|NCT01727726|147747492|OTHER||Mean Difference (Final Values)|0.52||||0.038|TWO_SIDED|95.0|0.03|1.02|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score||1.02|0.03|0.0380
74099257|NCT01727726|147747492|OTHER||Mean Difference (Final Values)|-0.34||||0.0436|TWO_SIDED|95.0|-0.66|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score||-0.01|-0.66|0.0436
74099258|NCT01727726|147747492|OTHER||Mean Difference (Final Values)|0.43||||0.035|TWO_SIDED|95.0|0.03|0.84|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score||0.84|0.03|0.0350
74099259|NCT01727726|147747492|OTHER||Mean Difference (Final Values)|-0.35||||0.0424|TWO_SIDED|95.0|-0.69|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score||-0.01|-0.69|0.0424
74099260|NCT01727726|147747492|OTHER||Mean Difference (Final Values)|0.33||||0.123|TWO_SIDED|95.0|-0.09|0.75|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score||0.75|-0.09|0.1230
74099261|NCT02714426|147747493|OTHER|||||||0.024||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,33) = 5.57, p = .024, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. First-order Autoregressive was best (which specifies homogeneous variance over time but allows one correlation between occasions).||||.024
74099262|NCT02714426|147747494|OTHER|||||||0.333||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.96, p = .333, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.333
74099263|NCT02714426|147747496|OTHER|||||||0.001||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-8) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31.069) = 15.046, p = .001, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.001
74099264|NCT02714426|147747497|OTHER|||||||0.448||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.589, p = .0.448, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.448
74099265|NCT02714426|147747498|OTHER|||||||0.439||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31) = 0.616, p = 0.439, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.439
74019310|NCT01727258|147590878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_ERROR_OF_MEAN|1.735|<|0.001|TWO_SIDED|95.0|9.17|16.03||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||16.03|9.17|<0.001
74019311|NCT01727258|147590879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08|STANDARD_ERROR_OF_MEAN|1.177|<|0.001|TWO_SIDED|95.0|3.76|8.41||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Sensodyne. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.41|3.76|<0.001
74019312|NCT01727258|147590879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.183||0.881|TWO_SIDED|95.0|-2.16|2.52||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.52|-2.16|0.881
74019313|NCT01727258|147590879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|STANDARD_ERROR_OF_MEAN|1.182|<|0.001|TWO_SIDED|95.0|3.57|8.24||Significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.24|3.57|<0.001
74051300|NCT03018340|147655403|SUPERIORITY||Difference in MMRM LSMs|-4.0|STANDARD_ERROR_OF_MEAN|1.09||0.0003|TWO_SIDED|95.0|-6.1|-1.9|||Mixed Models Analysis|||||-1.9|-6.1|0.0003
74051301|NCT03018340|147655403|SUPERIORITY||Difference in MMRM LSMs|0.5|STANDARD_ERROR_OF_MEAN|1.3||0.694|TWO_SIDED|95.0|-2.1|3.1|||Mixed Models Analysis|||||3.1|-2.1|0.6940
74051302|NCT00256204|147655446|SUPERIORITY_OR_OTHER|||||||0.0133|||||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 1mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start) and 2mg (delayed-start)are combined to one placebo group."||||0.0133
74051303|NCT00256204|147655446|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 2mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start)and 2mg (delayed-start) are combined to one placebo group."||||0.0001
74051304|NCT00256204|147655446|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center .|Repeated Measures|||Hypothesis #2: Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set).||||0.0250
74051305|NCT00256204|147655446|SUPERIORITY_OR_OTHER|||||||0.6028||95.0||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center|Repeated Measures|||Hypothesis #2:Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set.)||||0.6028
74051306|NCT00256204|147655446|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 1mg early-start group and the 1mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.0||||||90.0|-0.036|0.036||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."||0.036|-0.036|
74051307|NCT00256204|147655446|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 2mg early-start group and the 2mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.029||||||90.0|-0.005|0.062||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."||0.062|-0.005|
74051308|NCT00256204|147655447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.005|||<|0.0001||95.0|-3.857|-2.153|||ANCOVA|||The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates. For this analysis, both delayed start arms are pooled as a 'placebo arm'||-2.153|-3.857|<0.0001
74099266|NCT01695863|147747515|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.0001|TWO_SIDED|95.0|0.269|0.816|||t-test, 2 sided|||Right Colon||0.816|0.269|<0.0001
74099267|NCT01695863|147747515|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.005|TWO_SIDED|95.0|0.122|0.655|||t-test, 2 sided|||Transverse Colon||0.655|0.122|0.005
74099268|NCT01695863|147747515|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.08|TWO_SIDED|95.0|-0.029|0.484|||t-test, 2 sided|||Left Colon||0.484|-0.029|0.08
74099269|NCT01695863|147747516|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.093|TWO_SIDED||||||t-test, 2 sided|||Calcium||||0.093
74099270|NCT01695863|147747516|SUPERIORITY||Mean Difference (Final Values)|2.03||||0.801|TWO_SIDED||||||t-test, 2 sided|||Glucose||||0.801
74099271|NCT01695863|147747516|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.599|TWO_SIDED||||||t-test, 2 sided|||Blood Urea Nitrogen||||0.599
74099272|NCT01695863|147747516|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.696|TWO_SIDED||||||t-test, 2 sided|||Creatinine||||0.696
74099273|NCT01695863|147747516|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.042|TWO_SIDED||||||t-test, 2 sided|||Sodium||||.042
74099274|NCT01695863|147747516|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.596|TWO_SIDED||||||t-test, 2 sided|||Potassium||||0.596
74099275|NCT01695863|147747516|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.107|TWO_SIDED||||||t-test, 2 sided|||Chloride||||0.107
74099276|NCT01695863|147747516|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.351|TWO_SIDED||||||t-test, 2 sided|||Bicarbonate||||0.351
74099277|NCT01695863|147747517|SUPERIORITY||Mean Difference (Final Values)|-0.0438||||0.772|TWO_SIDED||||||t-test, 2 sided|||Nausea||||0.772
74099278|NCT01695863|147747517|SUPERIORITY||Mean Difference (Final Values)|-0.2821||||0.028|TWO_SIDED||||||t-test, 2 sided|||Vomiting||||0.028
74099279|NCT01695863|147747517|SUPERIORITY||Mean Difference (Final Values)|-0.2102||||0.235|TWO_SIDED||||||t-test, 2 sided|||Bloating||||0.235
74099280|NCT01695863|147747517|SUPERIORITY||Mean Difference (Final Values)|-0.0547||||0.707|TWO_SIDED||||||t-test, 2 sided|||Abdominal pain or cramping||||0.707
74099281|NCT01695863|147747517|SUPERIORITY||Mean Difference (Final Values)|-0.0269||||0.773|TWO_SIDED||||||t-test, 2 sided|||Ability to complete entire prep||||0.773
74099282|NCT01695863|147747517|SUPERIORITY||Mean Difference (Final Values)|0.0498||||0.766|TWO_SIDED||||||t-test, 2 sided|||Difficulty/Inconvenience in completing prep||||0.766
74099283|NCT04762277|147747524|OTHER||Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-31.7|23.4|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||23.4|-31.7|
74099284|NCT04762277|147747525|OTHER||Mean Difference (Net)|-96.6|||||TWO_SIDED|95.0|-154.5|-38.8|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-38.8|-154.5|
74099285|NCT04762277|147747526|OTHER||Risk Difference (RD)|0.138|||||TWO_SIDED|95.0|-0.129|0.339|||||Risk difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference is calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.339|-0.129|
74099286|NCT04762277|147747527|OTHER||Mean Difference (Net)|-13.9|||||TWO_SIDED|95.0|-25.6|-2.3|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-2.3|-25.6|
74099287|NCT04762277|147747528|OTHER||Mean Difference (Net)|-19.8|||||TWO_SIDED|95.0|-36.9|-2.7|||||Difference of Least Squares Means was calculated as : Spesolimab- Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-2.7|-36.9|
74099288|NCT04762277|147747529|OTHER||Risk Difference (RD)|0.057|||||TWO_SIDED|95.0|-0.132|0.186|||||Risk difference was calculated as: Spesolimab-Placebo. 95% Confidence Interval (CI) for treatment difference is calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.186|-0.132|
74099289|NCT04762277|147747530|OTHER||Risk Difference (RD)|0.17|||||TWO_SIDED|95.0|-0.067|0.338|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.338|-0.067|
74051309|NCT00256204|147655447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.154|||<|0.0001||95.0|-4.004|-2.305|||ANCOVA|||"The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates.~For this analysis, both delayed start arms are pooled as a 'placebo arm'"||-2.305|-4.004|<0.0001
74051310|NCT03427528|147655448|OTHER|To assess paternal and maternal outcomes on the BDI-II we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our BDI-II.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
74099290|NCT04762277|147747531|OTHER||Risk Difference (RD)|0.183|||||TWO_SIDED|95.0|-0.079|0.375|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.375|-0.079|
74099291|NCT04762277|147747532|OTHER||Risk Difference (RD)|-0.091|||||TWO_SIDED|95.0|-0.331|0.089|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.089|-0.331|
74099292|NCT04762277|147747533|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-4.4|4.3|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||4.3|-4.4|
74099293|NCT04762277|147747534|OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-9.5|6.9|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||6.9|-9.5|
74099294|NCT00642278|147747573|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.747|-0.148||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.148|-0.747|<0.001
74099295|NCT00642278|147747573|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.804|-0.207||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.207|-0.804|<0.001
74099296|NCT00642278|147747573|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.841|-0.244||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.244|-0.841|<0.001
73881459|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.19||||0.2116|TWO_SIDED|95.0|0.64|7.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.50|0.64|0.2116
74099297|NCT00642278|147747573|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-1.006|-0.405||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.405|-1.006|<0.001
74099298|NCT00642278|147747573|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-1.029|-0.432||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.432|-1.029|<0.001
74099299|NCT00642278|147747573|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.862|-0.265||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.265|-0.862|<0.001
74099300|NCT00642278|147747574|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|95.0|-1.39|-0.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.34|-1.39|0.001
74099301|NCT00642278|147747574|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.98|-0.92|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.92|-1.98|<0.001
74099302|NCT00642278|147747574|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.33|-1.27|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.27|-2.33|<0.001
74099303|NCT00642278|147747574|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.32|-1.26|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.26|-2.32|<0.001
73881460|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1668|TWO_SIDED|95.0|0.7|7.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.83|0.70|0.1668
74051311|NCT03427528|147655449|OTHER|To assess paternal and maternal outcomes on the GAD-7, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our outcomes.|||||>|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||>0.05
74051312|NCT03427528|147655450|OTHER|To assess paternal and maternal outcomes on the PSS-10, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
74051313|NCT03427528|147655450|OTHER|To assess paternal and maternal outcomes on the PSS-10 we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
74051314|NCT03427528|147655451|OTHER||||||>|0.05|||||||t-test, 2 sided|||We used a single group longitudinal pre-post design to evaluate study outcomes||||>0.05
74051315|NCT01009333|147655461|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Mixed Models Analysis|||||||0.008
74051316|NCT01009333|147655462|SUPERIORITY_OR_OTHER|||||||0.589||95.0|||||Mixed Models Analysis|||||||0.589
74051317|NCT01009333|147655463|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|||||||0.04
74051318|NCT02074436|147655465|OTHER|||||||0.5|TWO_SIDED|0.001|||||Fisher Exact|||The results are from the first and only interim analysis focusing on the primary endpoint: proportion of patient with major bleeding (Grade 3 and 4) during the study. The interim analysis was performed after 11 patients in each arm were randomized and results were obtained. One-sided fisher's exact test was employed in the analysis. The null hypothesis is the probability of occurring major bleeding is the same for Arm A and Arm B||||0.5
74051319|NCT01955005|147655473|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||This was a 2x2 comparison using Fisher's exact due to low expected cell count. Fisher's exact p\<0.001||||<0.001
74051320|NCT01955005|147655474|SUPERIORITY_OR_OTHER||Z score|568.5||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
74051321|NCT01955005|147655475|SUPERIORITY_OR_OTHER||Table Probability|0.0142||||0.02|TWO_SIDED||||||Fisher's Exact|||||||0.02
74051322|NCT00352027|147655502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.997|||||||Cox Model|||The association of age with EFS was compared. P values from Score test were computed for the statistical significance.||||0.9970
74051323|NCT00352027|147655505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.997|||||||Cox Model|||||||0.9970
74051324|NCT00352027|147655537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.265||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.265
74051325|NCT00352027|147655537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.057
74051326|NCT00352027|147655537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.079
74051327|NCT00352027|147655537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.025
74051328|NCT00352027|147655537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.680
74051329|NCT00352027|147655538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
73881461|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1824|TWO_SIDED|95.0|0.67|7.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.98|0.67|0.1824
74051330|NCT00352027|147655538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
74051331|NCT00352027|147655538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
74051332|NCT00352027|147655538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.184
74051333|NCT00352027|147655538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
74051334|NCT00352027|147655539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.319||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.319
74051335|NCT00352027|147655539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.010
74051336|NCT00352027|147655539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.002
74051337|NCT00352027|147655539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.015
74051338|NCT00352027|147655539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.588||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.588
74051339|NCT00352027|147655540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.071
74051340|NCT00352027|147655540|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
74051341|NCT00352027|147655540|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
74051342|NCT00352027|147655540|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
74051343|NCT00352027|147655540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.707
74051344|NCT00352027|147655541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.042
74051345|NCT00352027|147655541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.025
74051346|NCT00352027|147655541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.013
74051347|NCT00352027|147655541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.027
74051348|NCT00352027|147655541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.243||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.243
74051349|NCT00352027|147655542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.546||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.546
74051350|NCT00352027|147655542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.242
74051351|NCT00352027|147655542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.372
74051352|NCT00352027|147655542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.503||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.503
74051353|NCT00352027|147655542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.372
74051354|NCT00352027|147655543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.558
74051355|NCT00352027|147655543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.039
74051356|NCT00352027|147655543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.162
74051357|NCT00352027|147655543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.162
74051358|NCT00352027|147655544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.381
74051359|NCT00352027|147655544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.006
74051360|NCT00352027|147655544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.277
74051361|NCT00352027|147655544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.134||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.134
74051362|NCT00352027|147655545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
74051363|NCT00352027|147655545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
74051364|NCT00352027|147655545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
74051365|NCT00352027|147655545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.858||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.858
74051366|NCT00352027|147655546|SUPERIORITY_OR_OTHER_LEGACY|||||||0.744||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.744
74051367|NCT00352027|147655546|SUPERIORITY_OR_OTHER_LEGACY|||||||0.075||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.075
74051368|NCT00352027|147655546|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.512
74051369|NCT00352027|147655546|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.088
74051370|NCT00352027|147655547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
74051371|NCT00352027|147655547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.041
74051372|NCT00352027|147655547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
74051373|NCT00352027|147655547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
74051374|NCT00352027|147655548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
74099304|NCT00642278|147747574|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.25|-1.19|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.19|-2.25|<0.001
74099305|NCT00642278|147747574|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.51|-0.46|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.46|-1.51|<0.001
74099306|NCT00642278|147747576|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|36.1|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|26.07|46.13|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||46.13|26.07|<0.001
74099307|NCT00642278|147747576|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|49.3|STANDARD_ERROR_OF_MEAN|5.13|<|0.001|TWO_SIDED|95.0|39.17|59.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||59.34|39.17|<0.001
74099308|NCT00642278|147747576|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|48.2|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|37.98|58.42|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||58.42|37.98|<0.001
74099309|NCT00642278|147747576|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|49.0|STANDARD_ERROR_OF_MEAN|5.11|<|0.001|TWO_SIDED|95.0|38.91|59.01|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||59.01|38.91|<0.001
74099310|NCT00642278|147747576|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|60.3|STANDARD_ERROR_OF_MEAN|5.13|<|0.001|TWO_SIDED|95.0|50.17|70.35|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||70.35|50.17|<0.001
74099311|NCT00642278|147747576|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|5.09||0.513|TWO_SIDED|95.0|-13.33|6.67|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||6.67|-13.33|0.513
74099312|NCT00642278|147747578|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.5||0.009|TWO_SIDED|95.0|-2.2|-0.3|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.3|-2.2|0.009
74099313|NCT00642278|147747578|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.5||0.002|TWO_SIDED|95.0|-2.5|-0.6|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.6|-2.5|0.002
74099314|NCT00642278|147747578|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.6|-0.7|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and mixed meal tolerance test.||||-0.7|-2.6|<0.001
73888131|NCT01746901|147309538|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.0136|TWO_SIDED|95.0|3.3|28.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.3|3.3|0.0136
74099315|NCT00642278|147747578|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.4|-3.3|<0.001
74099316|NCT00642278|147747578|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.4|-3.3|<0.001
74099317|NCT00642278|147747578|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.371|TWO_SIDED|95.0|-0.5|1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||1.4|-0.5|0.371
74099318|NCT03713619|147747584|SUPERIORITY||Odds Ratio, log|1.75||||0.007|TWO_SIDED|95.0|1.12|2.73|||Regression, Logistic|||Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)||2.73|1.12|0.0070
74099319|NCT03713619|147747584|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0418|TWO_SIDED|95.0|0.95|2.32|||Regression, Logistic|||Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)||2.32|0.95|0.0418
74099320|NCT03713619|147747585|SUPERIORITY||Least square Mean Difference|-23.05|||<|0.0001|TWO_SIDED|95.0|-33.9|-12.21|||ANCOVA|||Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)||-12.21|-33.90|<0.0001
74099321|NCT03713619|147747585|SUPERIORITY||Least Square Mean difference|-18.46||||0.0004|TWO_SIDED|95.0|-29.32|-7.6|||ANCOVA|||Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)||-7.60|-29.32|0.0004
74099322|NCT03713619|147747586|SUPERIORITY||Odds Ratio, log|0.42||||0.001|TWO_SIDED|95.0|0.25|0.73|||Regression, Logistic|||Logistic regression analysis of Flare over 16 weeks (multiple imputation)||0.73|0.25|0.0010
74099323|NCT03713619|147747586|SUPERIORITY||Odds Ratio (OR)|0.71||||0.0926|TWO_SIDED|95.0|0.43|1.17|||Regression, Logistic|||Logistic regression analysis of Flare over 16 weeks (multiple imputation)||1.17|0.43|0.0926
74099324|NCT03713619|147747587|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0248|TWO_SIDED|95.0|1.0|3.4|||Regression, Logistic|||Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)||3.40|1.00|0.0248
74099325|NCT03713619|147747587|SUPERIORITY||Odds Ratio, log|1.77||||0.0044|TWO_SIDED|95.0|1.15|2.0|||Regression, Logistic|||Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)||2.0|1.15|0.0044
74051375|NCT00352027|147655548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
74051376|NCT00352027|147655548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
73881462|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|0.85||||0.797|TWO_SIDED|95.0|0.25|2.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.90|0.25|0.7970
73881463|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|0.78||||0.7065|TWO_SIDED|95.0|0.21|2.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.85|0.21|0.7065
73881464|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9126|TWO_SIDED|95.0|0.29|3.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.93|0.29|0.9126
73881465|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.82||||0.1282|TWO_SIDED|95.0|0.74|10.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||10.70|0.74|0.1282
73881466|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2661|TWO_SIDED|95.0|0.58|7.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.04|0.58|0.2661
73881467|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7457|TWO_SIDED|95.0|0.36|4.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.09|0.36|0.7457
74051377|NCT00352027|147655548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
74051378|NCT00352027|147655549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.933
73881468|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.73||||0.4095|TWO_SIDED|95.0|0.47|6.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||6.41|0.47|0.4095
73881469|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9571|TWO_SIDED|95.0|0.28|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.77|0.28|0.9571
73881470|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8827|TWO_SIDED|95.0|0.23|3.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.59|0.23|0.8827
73881471|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5944|TWO_SIDED|95.0|0.17|2.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.74|0.17|0.5944
73881472|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.74||||0.1647|TWO_SIDED|95.0|0.66|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||11.39|0.66|0.1647
73881473|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|2.07||||0.2684|TWO_SIDED|95.0|0.57|7.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.48|0.57|0.2684
74051379|NCT00352027|147655549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.933
74051380|NCT00352027|147655549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.051
74051381|NCT00352027|147655549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0779||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.0779
74051382|NCT00352027|147655550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.415||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.415
74051383|NCT00352027|147655550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.005
74051384|NCT00352027|147655550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.245
74051385|NCT00352027|147655550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.005
73881474|NCT03192176|147297632|SUPERIORITY||Odds Ratio (OR)|1.48||||0.5338|TWO_SIDED|95.0|0.43|5.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.07|0.43|0.5338
74099326|NCT01908907|147747590|SUPERIORITY_OR_OTHER||Median Difference (Net)|13.5|STANDARD_ERROR_OF_MEAN|6.5||0.07|TWO_SIDED|95.0|0.2|28.7|||Regression, Linear|Outcome was transformed using a natural logarithm transformation. Models included gestational age group since the randomization was blocked.|Since analyzed on the log scale, estimates provide are % change rather than absolute change between group.|All analyses used the intent-to-treat study population. A linear mixed model was used to assess differences in time to full feeds, days on study drug, and gestational age at discharge. These models included a random effect for multiples, which was maintained in the model after testing. Fixed effects included treatment and GA group for time to full feeds and days on study drug and treatment effect for gestational age at discharge.||28.7|0.2|0.07
74099327|NCT01908907|147747591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.008||0.048|TWO_SIDED||||||Regression, Linear|This is a complex regression model including linear and quadratic growth and interactions as specified above.||Linear mixed models were used to explore growth over time (weight, length and head circumference). These models included a random effect for intercepts and slopes to account for subject specific growth over time as well as a random effect for possible correlation between twins and triplets present in the data set. Fixed effects included both a linear and quadratic time effect, GA at birth, treatment group, full feeds (yes/no), and interactions. Non-significant interactions were eliminated.||||0.048
74099328|NCT00761657|147747599|OTHER|||||||0.2073||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.2073
74099329|NCT00761657|147747599|OTHER|||||||0.0046||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0046
74099330|NCT00761657|147747599|OTHER|||||||0.086||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0860
74099331|NCT00761657|147747599|OTHER|||||||0.4005||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.4005
74099332|NCT00761657|147747599|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is presented for Day 26-29 timepoint. P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
73881475|NCT03192176|147297633|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.45||0.0179|TWO_SIDED|95.0|-1.95|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|Mixed model repeated measures (MMRM)|||Week 4||-0.18|-1.95|0.0179
74051386|NCT00352027|147655551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.814||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.814
74051387|NCT00352027|147655551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.553||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.553
74051388|NCT00352027|147655551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.173||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.173
74051389|NCT00352027|147655551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.122
74051390|NCT00352027|147655552|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
74051391|NCT00352027|147655553|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
74099333|NCT00761657|147747599|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
74099334|NCT00761657|147747599|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
74099335|NCT00761657|147747599|OTHER||||||<|0.0001|||||||t-test, 2 sided|Threshold for significance at 0.05 level.||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
74099336|NCT00761657|147747600|OTHER|||||||0.0507||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0507
74099337|NCT00761657|147747600|OTHER|||||||0.4502||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.4502
74099338|NCT00761657|147747600|OTHER|Threshold for significance at 0.05 level.||||||0.1603|||||||t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.1603
74099339|NCT00761657|147747600|OTHER|||||||0.9816||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.9816
74099340|NCT00761657|147747600|OTHER|||||||0.0139||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0139
74099341|NCT00761657|147747600|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
73881476|NCT03192176|147297633|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0027|TWO_SIDED|95.0|-2.25|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.47|-2.25|0.0027
73881477|NCT03192176|147297633|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45||0.0004|TWO_SIDED|95.0|-2.5|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.73|-2.50|0.0004
73881478|NCT03192176|147297633|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.46||0.0009|TWO_SIDED|95.0|-2.43|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.64|-2.43|0.0009
74051392|NCT00352027|147655554|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
74051393|NCT00352027|147655555|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
74051394|NCT00352027|147655556|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
74051395|NCT00352027|147655557|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
74051396|NCT00352027|147655558|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
74051397|NCT00352027|147655559|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
74051398|NCT00352027|147655560|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
74051399|NCT00352027|147655561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Generalized Estimating Equations (GEE)|||||||0.005
74051400|NCT00352027|147655562|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
74099342|NCT00761657|147747600|OTHER|||||||0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0001
74099343|NCT00761657|147747600|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
74099344|NCT03151408|147747627|SUPERIORITY|||||||0.8275||||||P-value stratified by cytogenetic risk factor and ECOG performance status|Log Rank|||||||0.8275
73881479|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.5806|TWO_SIDED|95.0|-1.14|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||0.64|-1.14|0.5806
73881480|NCT03192176|147297633|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.45||0.0105|TWO_SIDED|95.0|-2.03|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.27|-2.03|0.0105
73888132|NCT01746901|147309538|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||0.0039|TWO_SIDED|95.0|6.1|31.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.0|6.1|0.0039
74051401|NCT00352027|147655563|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
74051402|NCT00352027|147655564|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
74051403|NCT00352027|147655565|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
74051404|NCT00352027|147655566|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
74051405|NCT00352027|147655567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.908|||||||Log Rank|||||||0.908
74051406|NCT00352027|147655568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178|||||||Log Rank|||||||0.178
74051407|NCT00352027|147655569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411|||||||Log Rank|||||||0.411
74051408|NCT00352027|147655571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4318|||||||Cox Model|||||||0.4318
74051409|NCT00352027|147655572|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2199|||||||Cox Model|||||||0.2199
74051410|NCT00352027|147655573|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8946|||||||Cox Model|||||||0.8946
74051411|NCT04111185|147655596|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
74051412|NCT00742391|147655606|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
74051413|NCT00742391|147655607|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0001
74051414|NCT01981096|147655613|SUPERIORITY|||||||0.011||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.||||.011
74051415|NCT01981096|147655614|SUPERIORITY|||||||0.055||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.||||.055
74051416|NCT01225211|147655628|SUPERIORITY_OR_OTHER||LS Mean difference|-2.679||||0.267|TWO_SIDED|95.0|-7.484|2.125|||ANCOVA|||||2.125|-7.484|0.267
74051417|NCT01225211|147655628|SUPERIORITY_OR_OTHER||LS Mean difference|-9.676|||<|0.001|TWO_SIDED|95.0|-14.801|-4.551|||ANCOVA|||||-4.551|-14.801|<0.001
74051418|NCT01225211|147655629|SUPERIORITY_OR_OTHER||LS Mean difference|-1.306||||0.68|TWO_SIDED|95.0|-7.565|4.953|||ANCOVA|||||4.953|-7.565|0.680
74051419|NCT01225211|147655629|SUPERIORITY_OR_OTHER||LS Mean difference|-2.67||||0.409|TWO_SIDED|95.0|-9.053|3.712|||ANCOVA|||||3.712|-9.053|0.409
74051420|NCT01225211|147655629|SUPERIORITY_OR_OTHER||LS Mean difference|-4.526||||0.161|TWO_SIDED|95.0|-10.888|1.835|||ANCOVA|||||1.835|-10.888|0.161
74051421|NCT01225211|147655629|SUPERIORITY_OR_OTHER||LS Mean difference|-2.867||||0.396|TWO_SIDED|95.0|-9.543|3.81|||ANCOVA|||||3.810|-9.543|0.396
73881481|NCT03192176|147297633|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0048|TWO_SIDED|95.0|-2.16|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.39|-2.16|0.0048
74051422|NCT01225211|147655629|SUPERIORITY_OR_OTHER||LS Mean difference|-3.78||||0.365|TWO_SIDED|95.0|-12.028|4.467|||ANCOVA|||||4.467|-12.028|0.365
74051423|NCT01225211|147655630|SUPERIORITY_OR_OTHER||LS Mean difference|0.6||||0.5978|TWO_SIDED|95.0|-1.66|2.86|||Mixed Model Repeated Measure (MMRM)|||||2.86|-1.66|0.5978
74051424|NCT02109939|147655671|SUPERIORITY||Mean Difference (Net)|-2.836|STANDARD_ERROR_OF_MEAN|1.758||0.107|TWO_SIDED|95.0|-6.285|0.613|||Mixed Models Analysis|Repeated Measures including week 4.||||0.613|-6.285|0.1070
74051425|NCT02109939|147655672|SUPERIORITY||Mean Difference (Net)|-2.207|STANDARD_ERROR_OF_MEAN|1.653||0.1822|TWO_SIDED|95.0|-5.45|1.036|||Mixed Models Analysis|MMRM with week 4 data.||||1.036|-5.450|0.1822
74051426|NCT02109939|147655673|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0134|TWO_SIDED|95.0|1.07|1.86|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.86|1.07|0.0134
74051427|NCT02109939|147655676|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0066|TWO_SIDED|95.0|1.14|2.27|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||2.27|1.14|0.0066
74019314|NCT01727258|147590880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.72|STANDARD_ERROR_OF_MEAN|2.866||0.02|TWO_SIDED|95.0|-12.38|-1.05||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.05|-12.38|0.020
74051428|NCT02109939|147655679|SUPERIORITY||Odds Ratio (OR)|1.13||||0.2852|TWO_SIDED|95.0|0.9|1.43|||Generalized linear mixed model.|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.43|0.90|0.2852
74051429|NCT02109939|147655680|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0023|TWO_SIDED|95.0|1.14|1.79|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.79|1.14|0.0023
74051430|NCT02109939|147655689|SUPERIORITY||Odds Ratio (OR)|1.43||||0.014|TWO_SIDED|95.0|1.07|1.89|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.89|1.07|0.0140
74099345|NCT03151408|147747628|OTHER|||||||0.1244|||||||Cochran-Mantel-Haenszel|||||||0.1244
74099346|NCT03151408|147747629|OTHER|||||||0.143|||||||Cochran-Mantel-Haenszel|||||||0.1430
74099347|NCT03151408|147747630|SUPERIORITY|||||||0.9977|||||||Cochran-Mantel-Haenszel|||||||0.9977
74099348|NCT03151408|147747631|OTHER|||||||0.9959|||||||Cochran-Mantel-Haenszel|||||||0.9959
73881482|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.46||0.1801|TWO_SIDED|95.0|-1.52|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.29|-1.52|0.1801
74051431|NCT02109939|147655690|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0663|TWO_SIDED|95.0|0.98|1.76|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.76|0.98|0.0663
74051432|NCT01058356|147655697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|STANDARD_ERROR_OF_MEAN|0.4|<|0.05|TWO_SIDED|95.0|0.17|4.15|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"||4.15|0.17|<0.05
74051433|NCT01058356|147655698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.27|<|0.05|TWO_SIDED|95.0|0.18|1.55|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"||1.55|0.18|<0.05
74051434|NCT00606021|147655700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.1815|TWO_SIDED|95.0|0.42|1.37||The significant level for the primary outcome measure of progression free survival during maintenance phase is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||1.37|0.42|0.1815
74051435|NCT00606021|147655701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.1233|TWO_SIDED|95.0|0.4|1.26||The significant level for the secondary outcome measure of progression free survival during overall period is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||1.26|0.40|0.1233
74099349|NCT03151408|147747632|OTHER|||||||0.3502|||||||Cochran-Mantel-Haenszel|||||||0.3502
74099350|NCT03151408|147747633|OTHER|||||||0.0502|||||||Log Rank|||||||0.0502
74099351|NCT03151408|147747635|OTHER|||||||0.4656|||||||Log Rank|||||||0.4656
74099352|NCT03151408|147747636|OTHER|||||||0.7063|||||||Log Rank|||||||0.7063
74099353|NCT03151408|147747637|OTHER|||||||0.0592|||||||Log Rank|||||||0.0592
74099354|NCT03151408|147747638|OTHER|||||||0.3835|||||||Log Rank|||||||0.3835
74099355|NCT03151408|147747639|OTHER|||||||0.7099|||||||Cochran-Mantel-Haenszel|||||||0.7099
73881483|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.46||0.0609|TWO_SIDED|95.0|-1.76|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.04|-1.76|0.0609
73881484|NCT03192176|147297633|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.47||0.0028|TWO_SIDED|95.0|-2.33|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.49|-2.33|0.0028
74051436|NCT00606021|147655702|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.7239|TWO_SIDED|95.0|0.56|2.28||The significant level for the secondary outcome measure overall survival during maintenance period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||2.28|0.56|0.7239
74051437|NCT00606021|147655703|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.6376|TWO_SIDED|95.0|0.59|2.38||The significant level for the secondary outcome measure overall survival during overall period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||2.38|0.59|0.6376
74051438|NCT02140762|147655736|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|67.0|||<|0.0001|TWO_SIDED|95.0|65.0|69.0|||Generalized Linear Model||VE is based on the relative risk (RR). The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.||69|65|<0.0001
74051439|NCT02140762|147655736|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|4.6|||||TWO_SIDED||||||Generalized Linear Model|||vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
74051440|NCT02140762|147655736|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|12.7|||||TWO_SIDED||||||generalized linear model.|||Vaccine effectiveness \<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
74051441|NCT02140762|147655736|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|18.2|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
74051442|NCT02140762|147655736|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|59.1|||||TWO_SIDED|||||||||Vaccine effectiveness \<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
74051443|NCT02140762|147655737|SUPERIORITY_OR_OTHER||Vaccine effectiveness|44.0|||<|0.0001|TWO_SIDED|95.0|41.0|47.0|||General Linear Model (GLM)||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the LL of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the second injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains will be computed by mean of a generalized linear model.||47|41|< 0.0001
74051444|NCT02140762|147655737|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|9.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
74051445|NCT02140762|147655737|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|22.7|||||TWO_SIDED|||||||||Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
74051446|NCT02140762|147655737|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|19.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
74051447|NCT02140762|147655737|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|38.2|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
74051448|NCT02140762|147655738|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|46.0|||<|0.0001|TWO_SIDED|95.0|43.0|49.0|||Generalized Linear Model||VE is based on the relative risk (RR).The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects:treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤ 10%. If the lower limit of the 95% CI for VE is \>10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.||49|43|<0.0001
74051449|NCT02140762|147655738|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|25.5|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
74051450|NCT02140762|147655738|OTHER|For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].|Vaccine Effectiveness|19.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<30%||||
74051451|NCT02140762|147655738|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|10.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
74051452|NCT02140762|147655738|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|40.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
74051453|NCT02140762|147655739|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|20.0|||<|0.0001|TWO_SIDED|95.0|16.0|23.0||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|Generalized Linear Model||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the 2nd injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/% of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||23|16|< 0.0001
74051454|NCT02140762|147655739|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|36.4|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
74099356|NCT01235195|147747640|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|104.86|||||TWO_SIDED|90.0|100.12|109.83|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-72) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||109.83|100.12|
74051455|NCT02140762|147655739|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|15.5|||||TWO_SIDED|||||||||Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
74051456|NCT02140762|147655739|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|20.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
74051457|NCT02140762|147655739|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|11.8|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
74051458|NCT00989664|147655780|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||||||<0.001
74051459|NCT02055976|147655827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.838|STANDARD_ERROR_OF_MEAN|3.775|<|0.001|TWO_SIDED|95.0|-57.335|-42.34|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.340|-57.335|<0.001
74051460|NCT02055976|147655827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.754|STANDARD_ERROR_OF_MEAN|3.912|<|0.001|TWO_SIDED|95.0|-74.523|-58.986|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.986|-74.523|<0.001
74051461|NCT02055976|147655827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.534|STANDARD_ERROR_OF_MEAN|3.903|<|0.001|TWO_SIDED|95.0|-79.284|-63.784|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-63.784|-79.284|<0.001
74051462|NCT02055976|147655827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.531|STANDARD_ERROR_OF_MEAN|4.016|<|0.001|TWO_SIDED|95.0|-55.511|-39.551|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.551|-55.511|<0.001
74051463|NCT02055976|147655827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.624|STANDARD_ERROR_OF_MEAN|3.993|<|0.001|TWO_SIDED|95.0|-70.557|-54.691|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.691|-70.557|<0.001
74051464|NCT02055976|147655827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.268|STANDARD_ERROR_OF_MEAN|3.955|<|0.001|TWO_SIDED|95.0|-72.128|-56.409|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-56.409|-72.128|<0.001
74051465|NCT02055976|147655828|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.293|STANDARD_ERROR_OF_MEAN|3.587|<|0.001|TWO_SIDED|95.0|-49.417|-35.168|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.168|-49.417|<0.001
74099357|NCT01235195|147747641|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|105.34|||||TWO_SIDED|90.0|98.46|112.69|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed Cmax analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||112.69|98.46|
74099358|NCT01235195|147747643|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|106.1|||||TWO_SIDED|90.0|100.16|112.39|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-∞) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||112.39|100.16|
74099359|NCT01473524|147747646|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.||||<0.0001
73881485|NCT03192176|147297633|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.47||0.0018|TWO_SIDED|95.0|-2.4|-0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.55|-2.40|0.0018
74051466|NCT02055976|147655828|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.262|STANDARD_ERROR_OF_MEAN|3.696|<|0.001|TWO_SIDED|95.0|-63.603|-48.921|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.921|-63.603|<0.001
74051467|NCT02055976|147655828|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.384|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-68.733|-54.035|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.035|-68.733|<0.001
74051468|NCT02055976|147655828|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.578|STANDARD_ERROR_OF_MEAN|4.273|<|0.001|TWO_SIDED|95.0|-56.067|-39.088|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.088|-56.067|<0.001
74051469|NCT02055976|147655828|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-63.346|STANDARD_ERROR_OF_MEAN|4.244|<|0.001|TWO_SIDED|95.0|-71.776|-54.915|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.915|-71.776|<0.001
74051470|NCT02055976|147655828|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.691|STANDARD_ERROR_OF_MEAN|4.226|<|0.001|TWO_SIDED|95.0|-75.088|-58.295|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.295|-75.088|<0.001
74051471|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-67.254|STANDARD_ERROR_OF_MEAN|4.785|<|0.001|TWO_SIDED|95.0|-76.757|-57.752|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.752|-76.757|<0.001
74051472|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-87.122|STANDARD_ERROR_OF_MEAN|4.959|<|0.001|TWO_SIDED|95.0|-96.969|-77.275|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-77.275|-96.969|<0.001
74051473|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-93.327|STANDARD_ERROR_OF_MEAN|4.949|<|0.001|TWO_SIDED|95.0|-103.153|-83.501|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-83.501|-103.153|<0.001
74051474|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.724|STANDARD_ERROR_OF_MEAN|6.243|<|0.001|TWO_SIDED|95.0|-84.128|-59.321|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.321|-84.128|<0.001
74051475|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-96.206|STANDARD_ERROR_OF_MEAN|6.209|<|0.001|TWO_SIDED|95.0|-108.541|-83.872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-83.872|-108.541|<0.001
74051476|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.533|STANDARD_ERROR_OF_MEAN|6.145|<|0.001|TWO_SIDED|95.0|-110.743|-86.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-86.323|-110.743|<0.001
74051477|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.225|STANDARD_ERROR_OF_MEAN|4.736|<|0.001|TWO_SIDED|95.0|-65.63|-46.819|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.819|-65.630|<0.001
74051478|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-73.813|STANDARD_ERROR_OF_MEAN|4.881|<|0.001|TWO_SIDED|95.0|-83.507|-64.119|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.119|-83.507|<0.001
73881486|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.5519|TWO_SIDED|95.0|-1.19|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.64|-1.19|0.5519
74099360|NCT01473524|147747648|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.||||<0.0001
73881487|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.46||0.1922|TWO_SIDED|95.0|-1.51|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.31|-1.51|0.1922
73881488|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.46||0.0463|TWO_SIDED|95.0|-1.82|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.02|-1.82|0.0463
73881489|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.44||0.1288|TWO_SIDED|95.0|-1.53|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.19|-1.53|0.1288
74019315|NCT01727258|147590880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|2.86||0.964|TWO_SIDED|95.0|-5.52|5.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.78|-5.52|0.964
74099361|NCT01473524|147747649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.||||<0.0001
74099362|NCT01473524|147747650|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.||||<0.0001
74099363|NCT01473524|147747651|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
74099364|NCT01473524|147747651|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
74099365|NCT01473524|147747652|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||0.0004
73881490|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.44||0.0577|TWO_SIDED|95.0|-1.72|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.03|-1.72|0.0577
73881491|NCT03192176|147297633|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0027|TWO_SIDED|95.0|-2.26|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.48|-2.26|0.0027
74019316|NCT01727258|147590880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.85|STANDARD_ERROR_OF_MEAN|2.845||0.017|TWO_SIDED|95.0|-12.47|-1.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.23|-12.47|0.017
74019317|NCT01727258|147590881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.92|STANDARD_ERROR_OF_MEAN|3.327||0.039|TWO_SIDED|95.0|-13.5|-0.35||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.35|-13.50|0.039
74019318|NCT01727258|147590881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.06|STANDARD_ERROR_OF_MEAN|3.317||0.13|TWO_SIDED|95.0|-1.5|11.61||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||11.61|-1.50|0.130
74019319|NCT01727258|147590881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.98|STANDARD_ERROR_OF_MEAN|3.313|<|0.001|TWO_SIDED|95.0|-18.53|-5.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.43|-18.53|<0.001
74019320|NCT01727258|147590882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.26|STANDARD_ERROR_OF_MEAN|3.163||0.01|TWO_SIDED|95.0|-14.51|-2.0||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-2.00|-14.51|0.010
74019321|NCT01727258|147590882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|3.16||0.179|TWO_SIDED|95.0|-1.98|10.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||10.51|-1.98|0.179
73881492|NCT03192176|147297633|SUPERIORITY||-1.3|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0043|TWO_SIDED|95.0|-2.2|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.41|-2.20|0.0043
74051479|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-81.239|STANDARD_ERROR_OF_MEAN|4.885|<|0.001|TWO_SIDED|95.0|-90.939|-71.538|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-71.538|-90.939|<0.001
74051480|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-72.573|STANDARD_ERROR_OF_MEAN|5.983|<|0.001|TWO_SIDED|95.0|-84.461|-60.684|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.684|-84.461|<0.001
74051481|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-96.222|STANDARD_ERROR_OF_MEAN|5.948|<|0.001|TWO_SIDED|95.0|-108.039|-84.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.405|-108.039|<0.001
74051482|NCT02055976|147655830|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-102.184|STANDARD_ERROR_OF_MEAN|5.919|<|0.001|TWO_SIDED|95.0|-113.945|-90.424|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-90.424|-113.945|<0.001
74051483|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-69.537|STANDARD_ERROR_OF_MEAN|5.721|<|0.001|TWO_SIDED|95.0|-80.9|-58.175|||Mixed Models Analysis|One-sided p-value (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.175|-80.900|<0.001
74051484|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.446|STANDARD_ERROR_OF_MEAN|5.855|<|0.001|TWO_SIDED|95.0|-98.074|-74.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-74.818|-98.074|<0.001
74051485|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.273|STANDARD_ERROR_OF_MEAN|5.898|<|0.001|TWO_SIDED|95.0|-109.983|-86.563|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-86.563|-109.983|<0.001
74051486|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.435|STANDARD_ERROR_OF_MEAN|7.209|<|0.001|TWO_SIDED|95.0|-85.757|-57.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.112|-85.757|<0.001
74051487|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-94.959|STANDARD_ERROR_OF_MEAN|7.236|<|0.001|TWO_SIDED|95.0|-109.333|-80.585|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-80.585|-109.333|<0.001
74099366|NCT01473524|147747652|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
74051488|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.519|STANDARD_ERROR_OF_MEAN|7.15|<|0.001|TWO_SIDED|95.0|-112.727|-84.311|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.311|-112.727|<0.001
74051489|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.191|STANDARD_ERROR_OF_MEAN|5.741|<|0.001|TWO_SIDED|95.0|-66.592|-43.791|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-43.791|-66.592|<0.001
74099367|NCT01473524|147747653|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
73888133|NCT01746901|147309538|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1|||<|0.0001|TWO_SIDED|95.0|23.6|48.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.5|23.6|<0.0001
74051490|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-72.211|STANDARD_ERROR_OF_MEAN|5.848|<|0.001|TWO_SIDED|95.0|-83.825|-60.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.597|-83.825|<0.001
74099368|NCT01473524|147747653|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
74051491|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-83.065|STANDARD_ERROR_OF_MEAN|5.913|<|0.001|TWO_SIDED|95.0|-94.807|-71.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-71.323|-94.807|<0.001
74051492|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-73.879|STANDARD_ERROR_OF_MEAN|6.678|<|0.001|TWO_SIDED|95.0|-87.147|-60.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.612|-87.147|<0.001
74051493|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-95.428|STANDARD_ERROR_OF_MEAN|6.697||0.001|TWO_SIDED|95.0|-108.732|-82.124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-82.124|-108.732|0.001
74051494|NCT02055976|147655832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-104.859|STANDARD_ERROR_OF_MEAN|6.654|<|0.001|TWO_SIDED|95.0|-118.079|-91.639|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-91.639|-118.079|<0.001
74051495|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.642|STANDARD_ERROR_OF_MEAN|2.717|<|0.001|TWO_SIDED|95.0|-37.039|-26.246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.246|-37.039|<0.001
74051496|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.88|STANDARD_ERROR_OF_MEAN|2.781|<|0.001|TWO_SIDED|95.0|-45.403|-34.358|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.358|-45.403|<0.001
74051497|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.889|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-51.45|-40.329|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-40.329|-51.450|<0.001
74051498|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.137|STANDARD_ERROR_OF_MEAN|3.006|<|0.001|TWO_SIDED|95.0|-36.11|-24.164|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-24.164|-36.110|<0.001
74051499|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.525|STANDARD_ERROR_OF_MEAN|3.018|<|0.001|TWO_SIDED|95.0|-45.52|-33.531|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.531|-45.520|<0.001
74099369|NCT01473524|147747654|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
74099370|NCT01473524|147747654|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
74099371|NCT01473524|147747655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||0.0003
74099372|NCT01473524|147747655|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor||||||<0.0001
74051500|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.372|STANDARD_ERROR_OF_MEAN|2.983|<|0.001|TWO_SIDED|95.0|-47.299|-35.445|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.445|-47.299|<0.001
74051501|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.374|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|-30.717|-20.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-20.032|-30.717|<0.001
74051502|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.49|STANDARD_ERROR_OF_MEAN|2.741|<|0.001|TWO_SIDED|95.0|-38.934|-28.047|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-28.047|-38.934|<0.001
74099373|NCT01473524|147747656|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
74099374|NCT01473524|147747656|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
74051503|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-38.76|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-44.262|-33.258|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.258|-44.262|<0.001
74051504|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.847|STANDARD_ERROR_OF_MEAN|2.879|<|0.001|TWO_SIDED|95.0|-36.568|-25.127|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-25.127|-36.568|<0.001
74051505|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.019|STANDARD_ERROR_OF_MEAN|2.887|<|0.001|TWO_SIDED|95.0|-45.754|-34.285|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.285|-45.754|<0.001
74051506|NCT02055976|147655833|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.947|STANDARD_ERROR_OF_MEAN|2.869|<|0.001|TWO_SIDED|95.0|-49.647|-38.247|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-38.247|-49.647|<0.001
74051507|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.118|STANDARD_ERROR_OF_MEAN|3.344|<|0.001|TWO_SIDED|95.0|-47.76|-34.476|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.476|-47.760|<0.001
74051508|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.787|STANDARD_ERROR_OF_MEAN|3.402|<|0.001|TWO_SIDED|95.0|-61.543|-48.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.032|-61.543|<0.001
74051509|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-60.549|STANDARD_ERROR_OF_MEAN|3.453|<|0.001|TWO_SIDED|95.0|-67.403|-53.694|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-53.694|-67.403|<0.001
74051510|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.589|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-43.999|-29.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-29.178|-43.999|<0.001
74051511|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.683|STANDARD_ERROR_OF_MEAN|3.734|<|0.001|TWO_SIDED|95.0|-62.102|-47.265|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-47.265|-62.102|<0.001
74051512|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.517|STANDARD_ERROR_OF_MEAN|3.688|<|0.001|TWO_SIDED|95.0|-63.845|-49.189|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.189|-63.845|<0.001
74051513|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.262|STANDARD_ERROR_OF_MEAN|3.196|<|0.001|TWO_SIDED|95.0|-39.608|-26.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.915|-39.608|<0.001
74051514|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.956|STANDARD_ERROR_OF_MEAN|3.239|<|0.001|TWO_SIDED|95.0|-52.388|-39.523|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.523|-52.388|<0.001
74051515|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.5|STANDARD_ERROR_OF_MEAN|3.305|<|0.001|TWO_SIDED|95.0|-58.063|-44.937|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-44.937|-58.063|<0.001
74051516|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.474|STANDARD_ERROR_OF_MEAN|3.547|<|0.001|TWO_SIDED|95.0|-47.523|-33.426|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.426|-47.523|<0.001
74051517|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.634|STANDARD_ERROR_OF_MEAN|3.549|<|0.001|TWO_SIDED|95.0|-61.685|-47.583|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-47.583|-61.685|<0.001
74051518|NCT02055976|147655835|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.608|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-66.602|-52.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-52.614|-66.602|<0.001
74051519|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.265|STANDARD_ERROR_OF_MEAN|3.566|<|0.001|TWO_SIDED|95.0|-50.347|-36.183|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-36.183|-50.347|<0.001
74051520|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-57.962|STANDARD_ERROR_OF_MEAN|3.628|<|0.001|TWO_SIDED|95.0|-65.167|-50.758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.758|-65.167|<0.001
74051521|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.729|STANDARD_ERROR_OF_MEAN|3.682|<|0.001|TWO_SIDED|95.0|-72.039|-57.419|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.419|-72.039|<0.001
74051522|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.428|STANDARD_ERROR_OF_MEAN|3.535|<|0.001|TWO_SIDED|95.0|-43.451|-29.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-29.405|-43.451|<0.001
74051523|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-53.296|STANDARD_ERROR_OF_MEAN|3.538|<|0.001|TWO_SIDED|95.0|-60.325|-46.267|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.267|-60.325|<0.001
74051524|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.489|STANDARD_ERROR_OF_MEAN|3.496|<|0.001|TWO_SIDED|95.0|-62.436|-48.542|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.542|-62.436|<0.001
74051525|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-35.288|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-42.059|-28.516|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-28.516|-42.059|<0.001
74051526|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.845|STANDARD_ERROR_OF_MEAN|3.456|<|0.001|TWO_SIDED|95.0|-55.709|-41.982|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-41.982|-55.709|<0.001
74051527|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.114|STANDARD_ERROR_OF_MEAN|3.526|<|0.001|TWO_SIDED|95.0|-62.116|-48.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.112|-62.116|<0.001
74051528|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.045|STANDARD_ERROR_OF_MEAN|3.56|<|0.001|TWO_SIDED|95.0|-47.118|-32.971|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-32.971|-47.118|<0.001
74051529|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-53.81|STANDARD_ERROR_OF_MEAN|3.56|<|0.001|TWO_SIDED|95.0|-60.883|-46.737|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.737|-60.883|<0.001
73888134|NCT01746901|147309538|SUPERIORITY_OR_OTHER||LS Mean Difference|15.4||||0.0157|TWO_SIDED|95.0|2.9|27.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.8|2.9|0.0157
74051530|NCT02055976|147655836|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-58.62|STANDARD_ERROR_OF_MEAN|3.533|<|0.001|TWO_SIDED|95.0|-65.64|-51.6|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-51.600|-65.640|<0.001
74051531|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.896|STANDARD_ERROR_OF_MEAN|2.643|<|0.001|TWO_SIDED|95.0|3.646|14.145|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.145|3.646|<0.001
74051532|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|15.429|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|10.141|20.717|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||20.717|10.141|<0.001
74051533|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.321|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|6.959|17.683|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||17.683|6.959|<0.001
74051534|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.804|STANDARD_ERROR_OF_MEAN|3.041||0.014|TWO_SIDED|95.0|0.761|12.847|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.847|0.761|0.014
74051535|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.565|STANDARD_ERROR_OF_MEAN|3.023|<|0.001|TWO_SIDED|95.0|4.556|16.573|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.573|4.556|<0.001
74051536|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.895|STANDARD_ERROR_OF_MEAN|2.969|<|0.001|TWO_SIDED|95.0|6.993|18.796|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.796|6.993|<0.001
74051537|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.644|STANDARD_ERROR_OF_MEAN|3.266||0.005|TWO_SIDED|95.0|2.157|15.13|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.130|2.157|0.005
74051538|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.708|STANDARD_ERROR_OF_MEAN|3.272|<|0.001|TWO_SIDED|95.0|8.208|21.208|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||21.208|8.208|<0.001
74051539|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.168|STANDARD_ERROR_OF_MEAN|3.317|<|0.001|TWO_SIDED|95.0|4.58|17.757|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||17.757|4.580|<0.001
74099375|NCT02383810|147747659|SUPERIORITY|The overall hypothesis system was represented by the following pool of partial hypothesis systems: Hok: πGi = πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j HAk: πGi ≠πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j where πG is the probability of absence of Grade ≥2 CID for the Group. Each Ho involved 2 groups.|||||<|0.1||||||Overall alpha level 0.10 was maintained by correction for multiplicity according to Hommel's procedure.|Chi-squared|||Overall null hypothesis: All elsiglutide dose groups had equal proportion of subjects with max Grade≥2 diarrhea and this was equal to the one in the placebo group. This includes 6 individual hypotheses (i.e., 3 to compare each dose group vs. placebo and 3 to compare dose groups vs. each other). Raw p-values from Chi square tests were corrected for multiplicity according to the Hommel's procedure. Each of 6 hypotheses was then evaluated based on corrected p-value at alpha 0.10 (two-sided).||||<0.1
74099376|NCT00926783|147747705|SUPERIORITY_OR_OTHER|||||||0.048||||||The p-value was based on Fisher's exact test. There were no adjustments for multiple comparisons.|Fisher Exact|||The null hypothesis is that rates of free from atrial arrhythmia for the two arms, Targeted and Generalized, are the same. The alternative hypothesis is that the rates are not the same. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.||||0.048
74099377|NCT00926783|147747706|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||The null hypothesis is that the total RF delivery times for both arms are equal. The alternative hypothesis is that the total RF delivery times are not equal. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.||||0.002
74099378|NCT00741286|147747769|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||A linear mixed model for a repeated measures covariance pattern model with unstructured covariances within subjects was used. Two fixed effects were included: 1 between-subjects treatment effect (group: cilostazol, control) and 1 within-subject time effect (time: baseline, 14 days, 90 days). A possible difference in treatment across 14- and 90-day follow-up was analyzed by time x treatment interactions.||||<0.05
74051540|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.132|STANDARD_ERROR_OF_MEAN|2.609||0.001|TWO_SIDED|95.0|2.947|13.316|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.316|2.947|0.001
74051541|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.23|STANDARD_ERROR_OF_MEAN|2.592|<|0.001|TWO_SIDED|95.0|5.079|15.381|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.381|5.079|<0.001
74051542|NCT02055976|147655838|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.767|STANDARD_ERROR_OF_MEAN|2.565||0.014|TWO_SIDED|95.0|0.67|10.864|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.864|0.670|0.014
74051543|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.079|STANDARD_ERROR_OF_MEAN|1.905|<|0.001|TWO_SIDED|95.0|2.296|9.863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.863|2.296|<0.001
74051544|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.786|STANDARD_ERROR_OF_MEAN|1.918|<|0.001|TWO_SIDED|95.0|6.976|14.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.597|6.976|<0.001
74051545|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.069|STANDARD_ERROR_OF_MEAN|1.945|<|0.001|TWO_SIDED|95.0|5.206|12.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.932|5.206|<0.001
74051546|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.859|STANDARD_ERROR_OF_MEAN|2.173||0.014|TWO_SIDED|95.0|0.541|9.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.178|0.541|0.014
74051547|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.331|STANDARD_ERROR_OF_MEAN|2.161|<|0.001|TWO_SIDED|95.0|3.037|11.624|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||11.624|3.037|<0.001
74051548|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.075|STANDARD_ERROR_OF_MEAN|2.122|<|0.001|TWO_SIDED|95.0|4.856|13.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.293|4.856|<0.001
74051549|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.936|STANDARD_ERROR_OF_MEAN|2.266||0.005|TWO_SIDED|95.0|1.435|10.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.437|1.435|0.005
74099379|NCT00741286|147747769|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||To determine between-group differences of changes in the PIs at 14 and 90 days from the baseline study.||||<0.05
73888135|NCT01746901|147309538|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|20.5|<0.0001
74051550|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.213|STANDARD_ERROR_OF_MEAN|2.271|<|0.001|TWO_SIDED|95.0|5.702|14.724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.724|5.702|<0.001
74051551|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.056|STANDARD_ERROR_OF_MEAN|2.302|<|0.001|TWO_SIDED|95.0|3.484|12.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.629|3.484|<0.001
74051552|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.846|STANDARD_ERROR_OF_MEAN|1.778|<|0.001|TWO_SIDED|95.0|2.312|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.380|2.312|<0.001
74099380|NCT00741286|147747770|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
74099381|NCT01851330|147747788|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
74099382|NCT01851330|147747788|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
74051553|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.91|STANDARD_ERROR_OF_MEAN|1.766|<|0.001|TWO_SIDED|95.0|3.4|10.421|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.421|3.400|<0.001
74051554|NCT02055976|147655839|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.168|STANDARD_ERROR_OF_MEAN|1.748||0.01|TWO_SIDED|95.0|0.693|7.642|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.642|0.693|0.010
74051555|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.7208|STANDARD_ERROR_OF_MEAN|0.6289||0.127|TWO_SIDED|95.0|-0.5283|1.97|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.9700|-0.5283|0.127
74051556|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0574|STANDARD_ERROR_OF_MEAN|0.6461||0.053|TWO_SIDED|95.0|-0.2259|2.3406|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.3406|-0.2259|0.053
74051557|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2445|STANDARD_ERROR_OF_MEAN|0.6511||0.354|TWO_SIDED|95.0|-1.0486|1.5375|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.5375|-1.0486|0.354
74051558|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8055|STANDARD_ERROR_OF_MEAN|0.8615||0.176|TWO_SIDED|95.0|-0.9066|2.5177|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.5177|-0.9066|0.176
74051559|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0071|STANDARD_ERROR_OF_MEAN|0.8641||0.011|TWO_SIDED|95.0|0.2899|3.7242|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.7242|0.2899|0.011
74051560|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7116|STANDARD_ERROR_OF_MEAN|0.852||0.024|TWO_SIDED|95.0|0.0184|3.4049|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.4049|0.0184|0.024
74099383|NCT01851330|147747788|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
74051561|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8585|STANDARD_ERROR_OF_MEAN|0.7844||0.138|TWO_SIDED|95.0|-0.6992|2.4163|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.4163|-0.6992|0.138
74051562|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8807|STANDARD_ERROR_OF_MEAN|0.799||0.137|TWO_SIDED|95.0|-0.7064|2.4678|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.4678|-0.7064|0.137
74051563|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2624|STANDARD_ERROR_OF_MEAN|0.8053||0.373|TWO_SIDED|95.0|-1.337|1.8618|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.8618|-1.3370|0.373
74051564|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3239|STANDARD_ERROR_OF_MEAN|0.7472||0.333|TWO_SIDED|95.0|-1.1611|1.8089|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.8089|-1.1611|0.333
74051565|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.9322|STANDARD_ERROR_OF_MEAN|0.7488||0.006|TWO_SIDED|95.0|0.4441|3.4203|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.4203|0.4441|0.006
74099384|NCT01851330|147747788|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the confidence interval (CI) for the difference between groups was greater than -12%.|Difference in proportions|-3.2|||||TWO_SIDED|97.5|-8.3|1.8|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||1.8|-8.3|
73881493|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.4089|TWO_SIDED|95.0|-1.27|0.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.52|-1.27|0.4089
73881494|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.44||0.205|TWO_SIDED|95.0|-1.44|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.31|-1.44|0.2050
74051566|NCT02055976|147655841|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.834|STANDARD_ERROR_OF_MEAN|0.7442||0.133|TWO_SIDED|95.0|-0.6451|2.313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.3130|-0.6451|0.133
74051567|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0813|STANDARD_ERROR_OF_MEAN|2.0411||0.155|TWO_SIDED|95.0|-1.973|6.1356|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.1356|-1.9730|0.155
74051568|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.2608|STANDARD_ERROR_OF_MEAN|2.0965||0.062|TWO_SIDED|95.0|-0.9035|7.425|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.4250|-0.9035|0.062
74051569|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8224|STANDARD_ERROR_OF_MEAN|2.1126||0.349|TWO_SIDED|95.0|-3.3733|5.0182|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.0182|-3.3733|0.349
74051570|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.3254|STANDARD_ERROR_OF_MEAN|2.7702||0.202|TWO_SIDED|95.0|-3.1801|7.831|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.8310|-3.1801|0.202
74051571|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.1048|STANDARD_ERROR_OF_MEAN|2.7784||0.015|TWO_SIDED|95.0|0.5833|11.6263|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||11.6263|0.5833|0.015
74051572|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.2393|STANDARD_ERROR_OF_MEAN|2.7396||0.03|TWO_SIDED|95.0|-0.2058|10.6845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.6845|-0.2058|0.030
74051573|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.1827|STANDARD_ERROR_OF_MEAN|2.4251||0.185|TWO_SIDED|95.0|-2.6334|6.9988|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.9988|-2.6334|0.185
74051574|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.1376|STANDARD_ERROR_OF_MEAN|2.4716||0.195|TWO_SIDED|95.0|-2.7718|7.0469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.0469|-2.7718|0.195
74051575|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3113|STANDARD_ERROR_OF_MEAN|2.4909||0.45|TWO_SIDED|95.0|-4.6358|5.2584|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.2584|-4.6358|0.450
74051576|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.6078|STANDARD_ERROR_OF_MEAN|2.3322||0.397|TWO_SIDED|95.0|-4.0274|5.2431|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.2431|-4.0274|0.397
73881495|NCT03192176|147297633|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.44||0.0265|TWO_SIDED|95.0|-1.84|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.11|-1.84|0.0265
73881496|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.7617|TWO_SIDED|95.0|-1.2|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.88|-1.20|0.7617
74051577|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.7096|STANDARD_ERROR_OF_MEAN|2.3367||0.008|TWO_SIDED|95.0|1.0659|10.3532|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.3532|1.0659|0.008
74051578|NCT02055976|147655842|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.4558|STANDARD_ERROR_OF_MEAN|2.323||0.147|TWO_SIDED|95.0|-2.1608|7.0724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.0724|-2.1608|0.147
73881497|NCT03192176|147297633|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6061|TWO_SIDED|95.0|-0.77|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.32|-0.77|0.6061
74051579|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.9203|STANDARD_ERROR_OF_MEAN|1.3242|<|0.001|TWO_SIDED|95.0|-7.5504|-2.2901|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.2901|-7.5504|<0.001
74051580|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.1983|STANDARD_ERROR_OF_MEAN|1.3462|<|0.001|TWO_SIDED|95.0|-9.8718|-4.5249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.5249|-9.8718|<0.001
74051581|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.3118|STANDARD_ERROR_OF_MEAN|1.3505|<|0.001|TWO_SIDED|95.0|-9.9935|-4.6301|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.6301|-9.9935|<0.001
74051582|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.0629|STANDARD_ERROR_OF_MEAN|1.032||0.002|TWO_SIDED|95.0|-5.1132|-1.0125|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.0125|-5.1132|0.002
74051583|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.6209|STANDARD_ERROR_OF_MEAN|1.0367|<|0.001|TWO_SIDED|95.0|-5.6804|-1.5614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.5614|-5.6804|<0.001
74051584|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.1778|STANDARD_ERROR_OF_MEAN|1.0269|<|0.001|TWO_SIDED|95.0|-6.2184|-2.1372|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.1372|-6.2184|<0.001
74051585|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.2914|STANDARD_ERROR_OF_MEAN|1.2954||0.006|TWO_SIDED|95.0|-5.8649|-0.7178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.7178|-5.8649|0.006
74051586|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.3569|STANDARD_ERROR_OF_MEAN|1.3157|<|0.001|TWO_SIDED|95.0|-8.9706|-3.7432|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.7432|-8.9706|<0.001
74051587|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.3962|STANDARD_ERROR_OF_MEAN|1.3233|<|0.001|TWO_SIDED|95.0|-9.0247|-3.7677|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.7677|-9.0247|<0.001
74051588|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.9228|STANDARD_ERROR_OF_MEAN|0.9199|<|0.001|TWO_SIDED|95.0|-5.7506|-2.095|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.0950|-5.7506|<0.001
74051589|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.7094|STANDARD_ERROR_OF_MEAN|0.9244|<|0.001|TWO_SIDED|95.0|-6.5459|-2.8729|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.8729|-6.5459|<0.001
73881498|NCT03192176|147297633|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.54||0.7997|TWO_SIDED|95.0|-0.93|1.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.21|-0.93|0.7997
74051590|NCT02055976|147655844|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4374|STANDARD_ERROR_OF_MEAN|0.9187|<|0.001|TWO_SIDED|95.0|-6.263|-2.6118|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.6118|-6.2630|<0.001
74051591|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.4492|STANDARD_ERROR_OF_MEAN|10.2401||0.004|TWO_SIDED|95.0|-47.7872|-7.1112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.1112|-47.7872|0.004
74051592|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.5908|STANDARD_ERROR_OF_MEAN|10.4568|<|0.001|TWO_SIDED|95.0|-61.3577|-19.824|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-19.8240|-61.3577|<0.001
74051593|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.163|STANDARD_ERROR_OF_MEAN|10.5402||0.006|TWO_SIDED|95.0|-48.0927|-6.2332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.2332|-48.0927|0.006
74051594|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.1677|STANDARD_ERROR_OF_MEAN|8.8755||0.004|TWO_SIDED|95.0|-41.8023|-6.5332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.5332|-41.8023|0.004
74051595|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.2255|STANDARD_ERROR_OF_MEAN|8.9203||0.017|TWO_SIDED|95.0|-36.9471|-1.5038|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.5038|-36.9471|0.017
74051596|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-26.5155|STANDARD_ERROR_OF_MEAN|8.8387||0.002|TWO_SIDED|95.0|-44.0795|-8.9515|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-8.9515|-44.0795|0.002
74051597|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.3898|STANDARD_ERROR_OF_MEAN|5.1768|<|0.001|TWO_SIDED|95.0|-28.6698|-8.1097|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-8.1097|-28.6698|<0.001
74051598|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.7882|STANDARD_ERROR_OF_MEAN|5.264|<|0.001|TWO_SIDED|95.0|-47.2423|-26.3341|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.3341|-47.2423|<0.001
74051599|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.8453|STANDARD_ERROR_OF_MEAN|5.3084|<|0.001|TWO_SIDED|95.0|-47.3864|-26.3041|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.3041|-47.3864|<0.001
74051600|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.9411|STANDARD_ERROR_OF_MEAN|7.8656|<|0.001|TWO_SIDED|95.0|-48.5748|-17.3075|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.3075|-48.5748|<0.001
74051601|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.3176|STANDARD_ERROR_OF_MEAN|7.9032|<|0.001|TWO_SIDED|95.0|-47.0238|-15.6114|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-15.6114|-47.0238|<0.001
74051602|NCT02055976|147655845|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.847|STANDARD_ERROR_OF_MEAN|7.8576|<|0.001|TWO_SIDED|95.0|-48.465|-17.2289|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.2289|-48.4650|<0.001
74099385|NCT01851330|147747788|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|-2.3|||||TWO_SIDED|97.5|-7.2|2.5|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||2.5|-7.2|
73888136|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|12.5|||<|0.0001|TWO_SIDED|95.0|6.4|18.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.6|6.4|<0.0001
74051603|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.663|STANDARD_ERROR_OF_MEAN|1.431|<|0.001|TWO_SIDED|95.0|4.82|10.506|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.506|4.820|<0.001
74051604|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.29|STANDARD_ERROR_OF_MEAN|1.46|<|0.001|TWO_SIDED|95.0|6.389|12.19|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.190|6.389|<0.001
74099386|NCT01851330|147747788|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-3.9|5.7|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||5.7|-3.9|
74051605|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.255|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|4.336|10.175|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.175|4.336|<0.001
74051606|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.228|STANDARD_ERROR_OF_MEAN|1.806||0.11|TWO_SIDED|95.0|-1.361|5.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.818|-1.361|0.110
74051607|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.578|STANDARD_ERROR_OF_MEAN|1.815||0.001|TWO_SIDED|95.0|1.972|9.185|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.185|1.972|0.001
74051608|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.712|STANDARD_ERROR_OF_MEAN|1.789||0.005|TWO_SIDED|95.0|1.156|8.268|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.268|1.156|0.005
74051609|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.888|STANDARD_ERROR_OF_MEAN|2.035||0.002|TWO_SIDED|95.0|1.844|9.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.932|1.844|0.002
74051610|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.251|STANDARD_ERROR_OF_MEAN|2.062|<|0.001|TWO_SIDED|95.0|5.153|13.349|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.349|5.153|<0.001
74099387|NCT00314951|147747809|NON_INFERIORITY_OR_EQUIVALENCE|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-2.9|8.0||||||H0: C(fidaxomicin) - C(Vancomycin) \<= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.||8.0|-2.9|
74099388|NCT00314951|147747810|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.4||||0.008|TWO_SIDED|95.0|-16.2|-2.5|||Chi-squared|||||-2.5|-16.2|0.008
74051611|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.264|STANDARD_ERROR_OF_MEAN|2.072||0.006|TWO_SIDED|95.0|1.147|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.380|1.147|0.006
74051612|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.065|STANDARD_ERROR_OF_MEAN|1.843||0.004|TWO_SIDED|95.0|1.402|8.728|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.728|1.402|0.004
74051613|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.096|STANDARD_ERROR_OF_MEAN|1.853||0.004|TWO_SIDED|95.0|1.413|8.78|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.780|1.413|0.004
74051614|NCT02055976|147655847|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.301|STANDARD_ERROR_OF_MEAN|1.832||0.011|TWO_SIDED|95.0|0.658|7.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.943|0.658|0.011
74099389|NCT00314951|147747811|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.2||||0.007|TWO_SIDED|95.0|2.8|17.5|||Chi-squared|||||17.5|2.8|0.007
74051615|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.389|STANDARD_ERROR_OF_MEAN|2.525|<|0.001|TWO_SIDED|95.0|8.373|18.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.405|8.373|<0.001
74051616|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.546|STANDARD_ERROR_OF_MEAN|2.576|<|0.001|TWO_SIDED|95.0|11.43|21.663|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||21.663|11.430|<0.001
74051617|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.288|STANDARD_ERROR_OF_MEAN|2.593|<|0.001|TWO_SIDED|95.0|8.137|18.438|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.438|8.137|<0.001
74051618|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.112|STANDARD_ERROR_OF_MEAN|2.909||0.081|TWO_SIDED|95.0|-1.671|9.895|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.895|-1.671|0.081
74051619|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.56|STANDARD_ERROR_OF_MEAN|2.927|<|0.001|TWO_SIDED|95.0|3.743|15.377|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.377|3.743|<0.001
74051620|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.826|STANDARD_ERROR_OF_MEAN|2.878|<|0.001|TWO_SIDED|95.0|4.103|15.548|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.548|4.103|<0.001
74051621|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.004|STANDARD_ERROR_OF_MEAN|3.326||0.002|TWO_SIDED|95.0|3.395|16.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.612|3.395|0.002
74051622|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.252|STANDARD_ERROR_OF_MEAN|3.367|<|0.001|TWO_SIDED|95.0|9.56|22.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||22.943|9.560|<0.001
74051623|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.571|STANDARD_ERROR_OF_MEAN|3.384||0.003|TWO_SIDED|95.0|2.847|16.295|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.295|2.847|0.003
74099390|NCT04181723|147747816|SUPERIORITY||LSM difference|-3.1|STANDARD_ERROR_OF_MEAN|1.3||0.0175|TWO_SIDED|95.0|-5.7|-0.6|||Mixed-effects model for repeated measure|||||-0.6|-5.7|0.0175
74051624|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.029|STANDARD_ERROR_OF_MEAN|2.858||0.001|TWO_SIDED|95.0|3.348|14.71|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.710|3.348|0.001
74051625|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.543|STANDARD_ERROR_OF_MEAN|2.876||0.002|TWO_SIDED|95.0|2.827|14.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.260|2.827|0.002
74051626|NCT02055976|147655848|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.898|STANDARD_ERROR_OF_MEAN|2.84||0.001|TWO_SIDED|95.0|3.252|14.544|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.544|3.252|0.001
74051627|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.462|STANDARD_ERROR_OF_MEAN|1.434|<|0.001|TWO_SIDED|95.0|-10.311|-4.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.614|-10.311|<0.001
74051628|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.693|STANDARD_ERROR_OF_MEAN|1.469|<|0.001|TWO_SIDED|95.0|-9.61|-3.776|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.776|-9.610|<0.001
74099391|NCT04181723|147747817|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.003|TWO_SIDED|95.0|-0.5|-0.1|||Mixed-effects model for repeated measure|||||-0.1|-0.5|0.0030
74051629|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.755|STANDARD_ERROR_OF_MEAN|1.479|<|0.001|TWO_SIDED|95.0|-11.692|-5.817|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.817|-11.692|<0.001
74051630|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.072|STANDARD_ERROR_OF_MEAN|1.773||0.484|TWO_SIDED|95.0|-3.596|3.451|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.451|-3.596|0.484
74051631|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.701|STANDARD_ERROR_OF_MEAN|1.793||0.173|TWO_SIDED|95.0|-5.264|1.862|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.862|-5.264|0.173
74051632|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.953|STANDARD_ERROR_OF_MEAN|1.761||0.135|TWO_SIDED|95.0|-5.452|1.546|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.546|-5.452|0.135
74051633|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.447|STANDARD_ERROR_OF_MEAN|2.406||0.034|TWO_SIDED|95.0|-9.23|0.335|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.335|-9.230|0.034
74051634|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.764|STANDARD_ERROR_OF_MEAN|2.442||0.003|TWO_SIDED|95.0|-11.617|-1.91|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.910|-11.617|0.003
74051635|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.951|STANDARD_ERROR_OF_MEAN|2.458||0.009|TWO_SIDED|95.0|-10.836|-1.066|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.066|-10.836|0.009
74051636|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|1.915||0.056|TWO_SIDED|95.0|-6.876|0.736|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.736|-6.876|0.056
74051637|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.557|STANDARD_ERROR_OF_MEAN|1.937||0.095|TWO_SIDED|95.0|-6.408|1.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.293|-6.408|0.095
74051638|NCT02055976|147655850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.271|STANDARD_ERROR_OF_MEAN|1.913||0.004|TWO_SIDED|95.0|-9.074|-1.469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.469|-9.074|0.004
74051639|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.88|STANDARD_ERROR_OF_MEAN|7.071|<|0.001|TWO_SIDED|95.0|-45.925|-17.836|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.836|-45.925|<0.001
74099392|NCT04181723|147747818|SUPERIORITY||LSM difference|1.0|STANDARD_ERROR_OF_MEAN|0.37||0.0064|TWO_SIDED|95.0|0.3|1.7|||Mixed-effects model for repeated measure|||||1.7|0.3|0.0064
74099393|NCT04181723|147747819|SUPERIORITY||LSM difference|-4.5|STANDARD_ERROR_OF_MEAN|4.67||0.3376|TWO_SIDED|95.0|-13.8|4.8|||ANCOVA|||||4.8|-13.8|0.3376
74051640|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.187|STANDARD_ERROR_OF_MEAN|7.242|<|0.001|TWO_SIDED|95.0|-43.571|-14.803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-14.803|-43.571|<0.001
74051641|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.657|STANDARD_ERROR_OF_MEAN|7.29|<|0.001|TWO_SIDED|95.0|-54.136|-25.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-25.178|-54.136|<0.001
74099394|NCT04181723|147747820|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3649|TWO_SIDED|95.0|-0.3|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.3|0.3649
74099395|NCT04181723|147747821|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2114|TWO_SIDED|95.0|-0.3|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.3|0.2114
74099396|NCT04181723|147747822|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.0257|TWO_SIDED|95.0|-0.6|0.0|||Mixed-effects model for repeated measure|||||0.0|-0.6|0.0257
74051642|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.681|STANDARD_ERROR_OF_MEAN|13.601||0.366|TWO_SIDED|95.0|-31.713|22.35|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||22.350|-31.713|0.366
74051643|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.227|STANDARD_ERROR_OF_MEAN|13.586||0.773|TWO_SIDED|95.0|-16.774|37.228|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||37.228|-16.774|0.773
74051644|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.646|STANDARD_ERROR_OF_MEAN|13.362||0.422|TWO_SIDED|95.0|-29.206|23.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||23.915|-29.206|0.422
74051645|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.911|STANDARD_ERROR_OF_MEAN|10.309||0.107|TWO_SIDED|95.0|-33.411|7.589|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.589|-33.411|0.107
74051646|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.119|STANDARD_ERROR_OF_MEAN|10.461||0.015|TWO_SIDED|95.0|-43.923|-2.315|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.315|-43.923|0.015
74051647|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.159|STANDARD_ERROR_OF_MEAN|10.535||0.054|TWO_SIDED|95.0|-38.108|3.789|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.789|-38.108|0.054
74051648|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.416|STANDARD_ERROR_OF_MEAN|12.718||0.029|TWO_SIDED|95.0|-49.696|0.865|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.865|-49.696|0.029
74099397|NCT04181723|147747823|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9799|TWO_SIDED|95.0|-0.2|0.2|||Mixed-effects model for repeated measure|||||0.2|-0.2|0.9799
74051649|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.287|STANDARD_ERROR_OF_MEAN|12.705||0.311|TWO_SIDED|95.0|-31.541|18.968|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.968|-31.541|0.311
74051650|NCT02055976|147655851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.443|STANDARD_ERROR_OF_MEAN|12.555||0.006|TWO_SIDED|95.0|-57.4|-7.485|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.485|-57.400|0.006
74051651|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-35.967|STANDARD_ERROR_OF_MEAN|10.822|<|0.001|TWO_SIDED|95.0|-57.463|-14.472|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-14.472|-57.463|<0.001
74099398|NCT04181723|147747824|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.5304|TWO_SIDED|95.0|-0.1|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.1|0.5304
74099399|NCT04181723|147747825|SUPERIORITY||LSM difference|-0.8|STANDARD_ERROR_OF_MEAN|1.4||0.5855|TWO_SIDED|95.0|-3.5|2.0|||ANCOVA|||||2.0|-3.5|0.5855
74099400|NCT04181723|147747826|SUPERIORITY||LSM difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.2507|TWO_SIDED|95.0|-0.1|0.4|||Mixed-effects model for repeated measure|||||0.4|-0.1|0.2507
74051652|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.186|STANDARD_ERROR_OF_MEAN|11.044||0.005|TWO_SIDED|95.0|-51.123|-7.249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.249|-51.123|0.005
74051653|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.01|STANDARD_ERROR_OF_MEAN|11.16|<|0.001|TWO_SIDED|95.0|-62.175|-17.845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.845|-62.175|<0.001
74051654|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.17|STANDARD_ERROR_OF_MEAN|10.906||0.614|TWO_SIDED|95.0|-18.502|24.842|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||24.842|-18.502|0.614
73881499|NCT03192176|147297633|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.55||0.3391|TWO_SIDED|95.0|-0.55|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.60|-0.55|0.3391
73881500|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.55||0.3934|TWO_SIDED|95.0|-1.55|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.61|-1.55|0.3934
74051655|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.563|STANDARD_ERROR_OF_MEAN|11.067||0.221|TWO_SIDED|95.0|-30.554|13.427|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.427|-30.554|0.221
74051656|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.649|STANDARD_ERROR_OF_MEAN|10.933||0.303|TWO_SIDED|95.0|-27.376|16.079|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.079|-27.376|0.303
74051657|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.003|STANDARD_ERROR_OF_MEAN|14.53||0.067|TWO_SIDED|95.0|-50.882|6.875|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.875|-50.882|0.067
74051658|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.761|STANDARD_ERROR_OF_MEAN|14.676||0.003|TWO_SIDED|95.0|-70.934|-12.588|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-12.588|-70.934|0.003
74051659|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-34.933|STANDARD_ERROR_OF_MEAN|14.832||0.01|TWO_SIDED|95.0|-64.41|-5.456|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.456|-64.410|0.010
74051660|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.978|STANDARD_ERROR_OF_MEAN|11.725||0.064|TWO_SIDED|95.0|-41.282|5.326|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.326|-41.282|0.064
74051661|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.654|STANDARD_ERROR_OF_MEAN|11.903||0.318|TWO_SIDED|95.0|-29.311|18.004|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.004|-29.311|0.318
74051662|NCT02055976|147655853|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.435|STANDARD_ERROR_OF_MEAN|11.807||0.052|TWO_SIDED|95.0|-42.902|4.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||4.032|-42.902|0.052
74099401|NCT04630158|147747835|SUPERIORITY||Least Square (LS) mean difference|1.6|STANDARD_ERROR_OF_MEAN|5.1||0.93|TWO_SIDED|95.0|-8.5|11.7||Reporting the adjusted p-value derived based on Dunett procedure.|Mixed Models Analysis|mixed-model repeated measures (MMRM) analysis||||11.7|-8.5|0.930
73881501|NCT03192176|147297633|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.54||0.975|TWO_SIDED|95.0|-1.08|1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.04|-1.08|0.9750
74051663|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.974|STANDARD_ERROR_OF_MEAN|7.674|<|0.001|TWO_SIDED|95.0|-41.217|-10.731|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-10.731|-41.217|<0.001
74051664|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.11|STANDARD_ERROR_OF_MEAN|7.831||0.004|TWO_SIDED|95.0|-36.665|-5.555|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.555|-36.665|0.004
74051665|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.034|STANDARD_ERROR_OF_MEAN|7.917|<|0.001|TWO_SIDED|95.0|-46.758|-15.31|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-15.310|-46.758|<0.001
74099402|NCT04630158|147747835|SUPERIORITY||Least Square (LS) mean difference|3.7|STANDARD_ERROR_OF_MEAN|5.11||0.699|TWO_SIDED|95.0|-6.4|13.8||Reporting the adjusted p-value derived based on Dunett procedure.|Mixed Models Analysis|mixed-model repeated measures (MMRM) analysis||||13.8|-6.4|0.699
74099403|NCT03020589|147747879|SUPERIORITY||Risk Ratio (RR)|1.27||||0.58|TWO_SIDED|95.0|0.67|2.05|||Fisher Exact|||||2.05|0.67|0.58
73881502|NCT03192176|147297633|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.883|TWO_SIDED|95.0|-1.13|0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.97|-1.13|0.8830
74051666|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.034|STANDARD_ERROR_OF_MEAN|9.553||0.799|TWO_SIDED|95.0|-10.948|27.015|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||27.015|-10.948|0.799
74051667|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.511|STANDARD_ERROR_OF_MEAN|9.682||0.398|TWO_SIDED|95.0|-21.748|16.727|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.727|-21.748|0.398
74051668|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.369|STANDARD_ERROR_OF_MEAN|9.58||0.515|TWO_SIDED|95.0|-18.668|19.407|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||19.407|-18.668|0.515
74051669|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.056|STANDARD_ERROR_OF_MEAN|8.801||0.128|TWO_SIDED|95.0|-27.549|7.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.437|-27.549|0.128
74051670|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.352|STANDARD_ERROR_OF_MEAN|8.882||0.004|TWO_SIDED|95.0|-42.008|-6.695|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.695|-42.008|0.004
74051671|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.994|STANDARD_ERROR_OF_MEAN|8.987||0.049|TWO_SIDED|95.0|-32.858|2.87|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.870|-32.858|0.049
74051672|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.83|STANDARD_ERROR_OF_MEAN|9.326||0.071|TWO_SIDED|95.0|-32.368|4.709|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||4.709|-32.368|0.071
74051673|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.378|STANDARD_ERROR_OF_MEAN|9.464||0.361|TWO_SIDED|95.0|-22.191|15.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.435|-22.191|0.361
74099404|NCT03020589|147747880|SUPERIORITY||Risk Ratio (RR)|1.26||||0.46|TWO_SIDED|95.0|0.72|2.02|||Fisher Exact|||||2.02|0.72|0.46
74099405|NCT00197496|147747903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.3|||<|0.05|TWO_SIDED|95.0|-72.1|19.6|||Regression, Linear|||||19.6|-72.1|<0.05
74099406|NCT00197496|147747906|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.4|TWO_SIDED|95.0|-3.6|9.2|||Regression, Linear|||||9.2|-3.6|0.40
73888137|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5||||0.255|TWO_SIDED|95.0|-2.6|9.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||9.6|-2.6|0.2550
74051674|NCT02055976|147655854|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.035|STANDARD_ERROR_OF_MEAN|9.389||0.056|TWO_SIDED|95.0|-33.698|3.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.629|-33.698|0.056
74051675|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-76.189|STANDARD_ERROR_OF_MEAN|5.431|<|0.001|TWO_SIDED|95.0|-86.975|-65.403|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-65.403|-86.975|<0.001
74051676|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-95.205|STANDARD_ERROR_OF_MEAN|5.556|<|0.001|TWO_SIDED|95.0|-106.238|-84.172|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.172|-106.238|<0.001
74099407|NCT00658021|147747947|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.363||0.444|TWO_SIDED|95.0|-1.01|0.45|||Mixed Models Analysis|||Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline HbA1c, background diabetes therapy strata, week of visit, baseline HbA1c-by-visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.||0.45|-1.01|0.444
74099408|NCT00658021|147747949|SUPERIORITY|||||||0.562|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \< 7% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.562
74051677|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-106.077|STANDARD_ERROR_OF_MEAN|5.622|<|0.001|TWO_SIDED|95.0|-117.239|-94.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-94.915|-117.239|<0.001
74051678|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.234|STANDARD_ERROR_OF_MEAN|6.622|<|0.001|TWO_SIDED|95.0|-84.39|-58.077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.077|-84.390|<0.001
74051679|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-100.638|STANDARD_ERROR_OF_MEAN|6.609|<|0.001|TWO_SIDED|95.0|-113.768|-87.508|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-87.508|-113.768|<0.001
73881503|NCT03192176|147297634|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|4.27||0.5872|TWO_SIDED|95.0|-6.09|10.73||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||10.73|-6.09|0.5872
74019322|NCT01727258|147590882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.52|STANDARD_ERROR_OF_MEAN|3.172|<|0.001|TWO_SIDED|95.0|-18.79|-6.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-6.25|-18.79|<0.001
74051680|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-103.386|STANDARD_ERROR_OF_MEAN|6.525|<|0.001|TWO_SIDED|95.0|-116.353|-90.42|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-90.420|-116.353|<0.001
74051681|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.124|STANDARD_ERROR_OF_MEAN|5.382|<|0.001|TWO_SIDED|95.0|-71.813|-50.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.435|-71.813|<0.001
74051682|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-81.837|STANDARD_ERROR_OF_MEAN|5.48|<|0.001|TWO_SIDED|95.0|-92.721|-70.954|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-70.954|-92.721|<0.001
74051683|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-89.683|STANDARD_ERROR_OF_MEAN|5.567|<|0.001|TWO_SIDED|95.0|-100.74|-78.627|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-78.627|-100.740|<0.001
74051684|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-76.747|STANDARD_ERROR_OF_MEAN|6.118|<|0.001|TWO_SIDED|95.0|-88.902|-64.593|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.593|-88.902|<0.001
74099409|NCT00658021|147747949|SUPERIORITY|||||||0.621|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \<= 6.5% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.621
74099410|NCT00658021|147747949|SUPERIORITY|||||||0.229|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \< 6.5% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.229
74019323|NCT01727258|147590883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.93|STANDARD_ERROR_OF_MEAN|3.543|<|0.001|TWO_SIDED|95.0|-18.93|-4.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-4.93|-18.93|<0.001
74051685|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-100.666|STANDARD_ERROR_OF_MEAN|6.098|<|0.001|TWO_SIDED|95.0|-112.781|-88.551|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-88.551|-112.781|<0.001
74051686|NCT02055976|147655856|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-109.49|STANDARD_ERROR_OF_MEAN|6.054|<|0.001|TWO_SIDED|95.0|-121.519|-97.462|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-97.462|-121.519|<0.001
74099411|NCT00658021|147747950|SUPERIORITY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.327||0.005|TWO_SIDED|95.0|-1.58|-0.28|||Mixed Models Analysis|||"Treatment difference in body weight at Week 4:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||-0.28|-1.58|0.005
74099412|NCT00658021|147747950|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.669||0.314|TWO_SIDED|95.0|-2.0|0.65|||Mixed Models Analysis|||"Treatment difference in body weight at Week 12:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||0.65|-2.00|0.314
74099413|NCT00658021|147747950|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.94||0.692|TWO_SIDED|95.0|-2.24|1.5|||Mixed Models Analysis|||"Treatment difference in body weight at Week 20:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||1.50|-2.24|0.692
74099414|NCT00658021|147747950|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.065||0.679|TWO_SIDED|95.0|-2.56|1.68|||Mixed Models Analysis|||"Treatment difference in body weight at Week 28:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||1.68|-2.56|0.679
74099415|NCT00658021|147747951|SUPERIORITY||LS Mean Difference|-0.281|STANDARD_ERROR_OF_MEAN|0.68||0.679|TWO_SIDED|95.0|-1.614|1.052|||ANCOVA|||Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum glucose, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.052|-1.614|0.679
74099416|NCT00658021|147747952|SUPERIORITY||LS Mean Difference|0.189|STANDARD_ERROR_OF_MEAN|0.5151||0.714|TWO_SIDED|95.0|-0.821|1.199|||ANCOVA|||Treatment difference for pre-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.199|-0.821|0.714
74099417|NCT00658021|147747952|SUPERIORITY||LS Mean Difference|0.513|STANDARD_ERROR_OF_MEAN|0.5245||0.329|TWO_SIDED|95.0|-0.516|1.541|||ANCOVA|||Treatment difference for post-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.541|-0.516|0.329
74099418|NCT00658021|147747952|SUPERIORITY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.4015||0.601|TWO_SIDED|95.0|-0.577|0.997|||ANCOVA|||Treatment difference for post-prandial excursion SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||0.997|-0.577|0.601
74099419|NCT00658021|147747952|SUPERIORITY||LS Mean Difference|0.316|STANDARD_ERROR_OF_MEAN|0.4749||0.505|TWO_SIDED|95.0|-0.615|1.248|||ANCOVA|||Treatment difference for overall SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.248|-0.615|0.505
74051687|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.772|STANDARD_ERROR_OF_MEAN|3.473|<|0.001|TWO_SIDED|95.0|-53.671|-39.874|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.874|-53.671|<0.001
74099420|NCT00658021|147747953|SUPERIORITY||LS Mean Difference|-10.82|STANDARD_ERROR_OF_MEAN|43.187||0.802|TWO_SIDED|95.0|-95.48|73.84|||ANCOVA|||Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum insulin, screening HbA1c strata and background diabetes therapy strata as fixed effects.||73.84|-95.48|0.802
74051688|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|3.554|<|0.001|TWO_SIDED|95.0|-66.257|-52.143|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-52.143|-66.257|<0.001
74051689|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.868|STANDARD_ERROR_OF_MEAN|3.595|<|0.001|TWO_SIDED|95.0|-74.007|-59.73|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.730|-74.007|<0.001
74051690|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.051|STANDARD_ERROR_OF_MEAN|3.595|<|0.001|TWO_SIDED|95.0|-47.195|-32.908|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-32.908|-47.195|<0.001
74051691|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.009|STANDARD_ERROR_OF_MEAN|3.587|<|0.001|TWO_SIDED|95.0|-63.135|-48.882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.882|-63.135|<0.001
74051692|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-57.576|STANDARD_ERROR_OF_MEAN|3.544|<|0.001|TWO_SIDED|95.0|-64.618|-50.533|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.533|-64.618|<0.001
74051693|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.991|STANDARD_ERROR_OF_MEAN|3.389|<|0.001|TWO_SIDED|95.0|-44.721|-31.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-31.260|-44.721|<0.001
74051694|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-50.856|STANDARD_ERROR_OF_MEAN|3.451|<|0.001|TWO_SIDED|95.0|-57.709|-44.002|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-44.002|-57.709|<0.001
74051695|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.354|STANDARD_ERROR_OF_MEAN|3.505|<|0.001|TWO_SIDED|95.0|-63.315|-49.393|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.393|-63.315|<0.001
74051696|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.172|STANDARD_ERROR_OF_MEAN|3.647|<|0.001|TWO_SIDED|95.0|-50.417|-35.926|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.926|-50.417|<0.001
74051697|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.698|STANDARD_ERROR_OF_MEAN|3.633|<|0.001|TWO_SIDED|95.0|-63.916|-49.48|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.480|-63.916|<0.001
74051698|NCT02055976|147655857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.305|STANDARD_ERROR_OF_MEAN|3.609|<|0.001|TWO_SIDED|95.0|-68.477|-54.134|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.134|-68.477|<0.001
74099421|NCT00658021|147747954|SUPERIORITY||LS Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|18.542||0.836|TWO_SIDED|95.0|-40.19|32.51|||ANCOVA|||Treatment difference for HOMA-B: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-B, screening HbA1c strata and background diabetes therapy strata as fixed effects.||32.51|-40.19|0.836
74051699|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.69928|STANDARD_ERROR_OF_MEAN|0.13216|<|0.001|TWO_SIDED|95.0|-1.96175|-1.43682|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.43682|-1.96175|<0.001
74051700|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.07922|STANDARD_ERROR_OF_MEAN|0.13446|<|0.001|TWO_SIDED|95.0|-2.34622|-1.81223|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.81223|-2.34622|<0.001
74051701|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.23886|STANDARD_ERROR_OF_MEAN|0.13553|<|0.001|TWO_SIDED|95.0|-2.50795|-1.96978|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.96978|-2.50795|<0.001
74051702|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.43281|STANDARD_ERROR_OF_MEAN|0.16311|<|0.001|TWO_SIDED|95.0|-1.75689|-1.10872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.10872|-1.75689|<0.001
74099422|NCT00658021|147747954|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|3.846||0.941|TWO_SIDED|95.0|-7.82|7.26|||ANCOVA|||Treatment difference for HOMA-S: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-S, screening HbA1c strata and background diabetes therapy strata as fixed effects.||7.26|-7.82|0.941
74051703|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.01501|STANDARD_ERROR_OF_MEAN|0.16217|<|0.001|TWO_SIDED|95.0|-2.33718|-1.69283|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.69283|-2.33718|<0.001
74051704|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.11359|STANDARD_ERROR_OF_MEAN|0.16038|<|0.001|TWO_SIDED|95.0|-2.4323|-1.79489|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.79489|-2.43230|<0.001
74051705|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.35298|STANDARD_ERROR_OF_MEAN|0.13609|<|0.001|TWO_SIDED|95.0|-1.62324|-1.08271|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.08271|-1.62324|<0.001
74051706|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.79615|STANDARD_ERROR_OF_MEAN|0.1379|<|0.001|TWO_SIDED|95.0|-2.07001|-1.52229|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.52229|-2.07001|<0.001
74051707|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.86921|STANDARD_ERROR_OF_MEAN|0.13927|<|0.001|TWO_SIDED|95.0|-2.14575|-1.59266|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.59266|-2.14575|<0.001
74051708|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.57311|STANDARD_ERROR_OF_MEAN|0.14333|<|0.001|TWO_SIDED|95.0|-1.85788|-1.28834|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.28834|-1.85788|<0.001
74051709|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.00256|STANDARD_ERROR_OF_MEAN|0.14228|<|0.001|TWO_SIDED|95.0|-2.28521|-1.7199|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.71990|-2.28521|<0.001
74051710|NCT02055976|147655859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.20298|STANDARD_ERROR_OF_MEAN|0.14142|<|0.001|TWO_SIDED|95.0|-2.48399|-1.92197|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.92197|-2.48399|<0.001
74099423|NCT01595386|147747957|NON_INFERIORITY_OR_EQUIVALENCE|Study sample size was powered to detect a 60% difference in LCOS between groups at α 0.05 and β 0.70, assuming the prevalence of LCOS after neonatal bypass of 65% (based on retrospective data of patients who died, required rescue steroids, ECMO, or epinephrine \> 0.1 μg/kg/min).||||||0.049|TWO_SIDED|||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||||||0.049
74051711|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.92915|STANDARD_ERROR_OF_MEAN|2.83037|<|0.001|TWO_SIDED|95.0|-47.55052|-36.30778|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-36.30778|-47.55052|<0.001
74051712|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.08604|STANDARD_ERROR_OF_MEAN|2.88356|<|0.001|TWO_SIDED|95.0|-56.81235|-45.35973|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-45.35973|-56.81235|<0.001
74051713|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.516|STANDARD_ERROR_OF_MEAN|2.91014|<|0.001|TWO_SIDED|95.0|-61.29424|-49.73777|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.73777|-61.29424|<0.001
74051714|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.30375|STANDARD_ERROR_OF_MEAN|3.07498|<|0.001|TWO_SIDED|95.0|-39.41376|-27.19373|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-27.19373|-39.41376|<0.001
74099424|NCT01595386|147747958|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.44|TWO_SIDED|95.0|||||Chi-squared|||||||0.44
74099425|NCT01595386|147747959|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.62|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.62
73881504|NCT03192176|147297634|SUPERIORITY||LSMean difference|3.8|STANDARD_ERROR_OF_MEAN|4.33||0.3779|TWO_SIDED|95.0|-4.7|12.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||12.35|-4.70|0.3779
74051715|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.8521|STANDARD_ERROR_OF_MEAN|3.05746|<|0.001|TWO_SIDED|95.0|-53.92668|-41.77751|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-41.77751|-53.92668|<0.001
74051716|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.65686|STANDARD_ERROR_OF_MEAN|3.02097|<|0.001|TWO_SIDED|95.0|-54.6606|-42.65313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.65313|-54.66060|<0.001
74051717|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.5292|STANDARD_ERROR_OF_MEAN|2.96599|<|0.001|TWO_SIDED|95.0|-39.42015|-27.63826|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-27.63826|-39.42015|<0.001
74051718|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.8568|STANDARD_ERROR_OF_MEAN|3.00531|<|0.001|TWO_SIDED|95.0|-49.82617|-37.88744|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-37.88744|-49.82617|<0.001
74051719|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.36865|STANDARD_ERROR_OF_MEAN|3.03981|<|0.001|TWO_SIDED|95.0|-52.40589|-40.33142|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-40.33142|-52.40589|<0.001
74051720|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-38.06019|STANDARD_ERROR_OF_MEAN|3.1361|<|0.001|TWO_SIDED|95.0|-44.29176|-31.82863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-31.82863|-44.29176|<0.001
74051721|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.57807|STANDARD_ERROR_OF_MEAN|3.1135|<|0.001|TWO_SIDED|95.0|-54.76397|-42.39217|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.39217|-54.76397|<0.001
74051722|NCT02055976|147655860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.87214|STANDARD_ERROR_OF_MEAN|3.09363|<|0.001|TWO_SIDED|95.0|-58.01968|-45.7246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-45.72460|-58.01968|<0.001
74051723|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33157|STANDARD_ERROR_OF_MEAN|0.02639|<|0.001|TWO_SIDED|95.0|-0.38399|-0.27916|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.27916|-0.38399|<0.001
74051724|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44402|STANDARD_ERROR_OF_MEAN|0.02682|<|0.001|TWO_SIDED|95.0|-0.49727|-0.39077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39077|-0.49727|<0.001
74051725|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.48314|STANDARD_ERROR_OF_MEAN|0.02698|<|0.001|TWO_SIDED|95.0|-0.53671|-0.42956|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.42956|-0.53671|<0.001
74051726|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.30542|STANDARD_ERROR_OF_MEAN|0.0323|<|0.001|TWO_SIDED|95.0|-0.3696|-0.24124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.24124|-0.36960|<0.001
74051727|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44143|STANDARD_ERROR_OF_MEAN|0.03183|<|0.001|TWO_SIDED|95.0|-0.50466|-0.37821|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.37821|-0.50466|<0.001
74051728|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.46235|STANDARD_ERROR_OF_MEAN|0.03148|<|0.001|TWO_SIDED|95.0|-0.52491|-0.3998|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39980|-0.52491|<0.001
74099426|NCT01595386|147747960|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
73881505|NCT03192176|147297634|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|4.34||0.3506|TWO_SIDED|95.0|-12.61|4.49||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||4.49|-12.61|0.3506
73881506|NCT03192176|147297634|SUPERIORITY||LSMean difference|1.0|STANDARD_ERROR_OF_MEAN|4.39||0.8236|TWO_SIDED|95.0|-7.66|9.62||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||9.62|-7.66|0.8236
74019324|NCT01727258|147590883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.54|STANDARD_ERROR_OF_MEAN|3.534||0.119|TWO_SIDED|95.0|-1.44|12.53||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||12.53|-1.44|0.119
74051729|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26949|STANDARD_ERROR_OF_MEAN|0.02615|<|0.001|TWO_SIDED|95.0|-0.32142|-0.21755|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.21755|-0.32142|<0.001
74051730|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.37493|STANDARD_ERROR_OF_MEAN|0.02649|<|0.001|TWO_SIDED|95.0|-0.42754|-0.32231|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.32231|-0.42754|<0.001
74051731|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.41199|STANDARD_ERROR_OF_MEAN|0.02676|<|0.001|TWO_SIDED|95.0|-0.46512|-0.35886|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.35886|-0.46512|<0.001
74051732|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31806|STANDARD_ERROR_OF_MEAN|0.02979|<|0.001|TWO_SIDED|95.0|-0.37723|-0.25888|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.25888|-0.37723|<0.001
74051733|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.42583|STANDARD_ERROR_OF_MEAN|0.02932|<|0.001|TWO_SIDED|95.0|-0.48409|-0.36758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.36758|-0.48409|<0.001
74051734|NCT02055976|147655862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45501|STANDARD_ERROR_OF_MEAN|0.02912|<|0.001|TWO_SIDED|95.0|-0.51287|-0.39715|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39715|-0.51287|<0.001
74051735|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.42411|STANDARD_ERROR_OF_MEAN|3.72907|<|0.001|TWO_SIDED|95.0|-56.83019|-42.01803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.01803|-56.83019|<0.001
74051736|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.63383|STANDARD_ERROR_OF_MEAN|3.7905|<|0.001|TWO_SIDED|95.0|-74.16086|-59.10681|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.10681|-74.16086|<0.001
74099427|NCT01595386|147747960|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.01|TWO_SIDED|95.0||||interleukin-6 at 12, 24, and 48 hour. A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.01
74099428|NCT01595386|147747960|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.01|TWO_SIDED|95.0||||TNF-alpha at 12, 24, and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.01
74099429|NCT01595386|147747960|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0||||Interleukin1-beta at 24 and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.05
73881507|NCT03192176|147297634|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|4.35||0.5949|TWO_SIDED|95.0|-6.24|10.87||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||10.87|-6.24|0.5949
73881508|NCT03192176|147297634|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.19||0.9237|TWO_SIDED|95.0|-8.65|7.85||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||7.85|-8.65|0.9237
74099430|NCT01595386|147747960|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0||||Interleukin-8 at 24 and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.05
73881509|NCT03192176|147297634|SUPERIORITY||LSMean difference|4.0|STANDARD_ERROR_OF_MEAN|4.32||0.3599|TWO_SIDED|95.0|-4.54|12.46||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||12.46|-4.54|0.3599
74019325|NCT01727258|147590883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47|STANDARD_ERROR_OF_MEAN|3.566|<|0.001|TWO_SIDED|95.0|-24.52|-10.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-10.42|-24.52|<0.001
74051737|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.72901|STANDARD_ERROR_OF_MEAN|3.81541|<|0.001|TWO_SIDED|95.0|-79.30431|-64.15371|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.15371|-79.30431|<0.001
74051738|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.56596|STANDARD_ERROR_OF_MEAN|3.92236|<|0.001|TWO_SIDED|95.0|-51.35899|-35.77293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.77293|-51.35899|<0.001
74051739|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.34926|STANDARD_ERROR_OF_MEAN|3.86432|<|0.001|TWO_SIDED|95.0|-70.02607|-54.67245|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.67245|-70.02607|<0.001
74051740|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-65.06617|STANDARD_ERROR_OF_MEAN|3.82052|<|0.001|TWO_SIDED|95.0|-72.65818|-57.47415|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.47415|-72.65818|<0.001
74051741|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.52435|STANDARD_ERROR_OF_MEAN|3.66973|<|0.001|TWO_SIDED|95.0|-47.81299|-33.23571|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.23571|-47.81299|<0.001
74051742|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.14495|STANDARD_ERROR_OF_MEAN|3.71641|<|0.001|TWO_SIDED|95.0|-63.52668|-48.76322|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.76322|-63.52668|<0.001
74051743|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.5637|STANDARD_ERROR_OF_MEAN|3.7569|<|0.001|TWO_SIDED|95.0|-69.0251|-54.1023|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.10230|-69.02510|<0.001
74051744|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.34109|STANDARD_ERROR_OF_MEAN|4.16385|<|0.001|TWO_SIDED|95.0|-54.61427|-38.06792|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-38.06792|-54.61427|<0.001
74051745|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.3789|STANDARD_ERROR_OF_MEAN|4.09957|<|0.001|TWO_SIDED|95.0|-69.52338|-53.23443|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-53.23443|-69.52338|<0.001
74019326|NCT01960855|147590884|OTHER||||||=|0.033|||||||Chi-squared|||||||= 0.033
74051746|NCT02055976|147655863|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.67274|STANDARD_ERROR_OF_MEAN|4.06866|<|0.001|TWO_SIDED|95.0|-72.75728|-56.5882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-56.58820|-72.75728|<0.001
74051747|NCT00394654|147655889|SUPERIORITY_OR_OTHER|||||||0.168|||||||Univariate 2-sample t-test|||||||0.168
74051748|NCT00394654|147655890|SUPERIORITY_OR_OTHER|||||||0.254|||||||Univariate 2-sample t-test|||||||0.254
74051749|NCT00394654|147655891|SUPERIORITY_OR_OTHER|||||||0.677|||||||Univariate 2-sample t-test|||||||0.677
74051750|NCT00394654|147655892|SUPERIORITY_OR_OTHER|||||||0.318|||||||Univariate 2-sample t-test|||||||0.318
74019327|NCT01960855|147590884|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
74019328|NCT01960855|147590884|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
74019329|NCT01960855|147590884|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
74019330|NCT01960855|147590885|OTHER||||||=|0.364|||||||Chi-squared|||||||= 0.364
74051751|NCT00394654|147655893|SUPERIORITY_OR_OTHER|||||||0.798|||||||Univariate 2-sample t-test|||||||0.798
74051752|NCT00394654|147655894|SUPERIORITY_OR_OTHER|||||||0.766|||||||Univariate 2-sample t-test|||||||0.766
74051753|NCT03756285|147655923|SUPERIORITY||Least Square Means Ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.12|0.52|||Mixed Models Analysis|Covariates: atrial fibrillation status at randomization, baseline value, treatment, visit, and treatment\*visit.||||0.52|0.12|<0.001
74051754|NCT03756285|147655924|SUPERIORITY||Least Square Means Ratio|0.97||||0.568|ONE_SIDED|95.0|0.74||||ANCOVA|Covariates: atrial fibrillation status at randomization, baseline value, treatment|||||0.74|0.568
74051755|NCT03756285|147655925|SUPERIORITY||Mean Difference (Final Values)|21.8||||0.407|TWO_SIDED|95.0|-30.5|74.1|||Mixed Models Analysis|Covariates: atrial fibrillation status at randomization, baseline value, treatment, visit, and treatment\*visit.||||74.1|-30.5|0.407
74051756|NCT01021293|147655936|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 1 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV||1.24|-1.28|
74099431|NCT01595386|147747960|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.03|TWO_SIDED|95.0||||IL-10 at 4 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.03
74099432|NCT01595386|147747961|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
74019331|NCT01960855|147590885|OTHER||||||=|0.014|||||||Chi-squared|||||||= 0.014
74019332|NCT01960855|147590885|OTHER||||||=|0.003|||||||Chi-squared|||||||= 0.003
74019333|NCT01960855|147590885|OTHER||||||=|0.008|||||||Chi-squared|||||||= 0.008
74019334|NCT01960855|147590886|OTHER||||||=|0.093|||||||Chi-squared|||||||= 0.093
74019335|NCT01960855|147590886|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
74019336|NCT01960855|147590886|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
74019337|NCT01960855|147590886|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
74019338|NCT01960855|147590887|OTHER||||||=|0.366|||||||Chi-squared|||||||= 0.366
74019339|NCT01960855|147590887|OTHER||||||=|0.17|||||||Chi-squared|||||||= 0.17
74019340|NCT01960855|147590887|OTHER||||||=|0.003|||||||Chi-squared|||||||= 0.003
74019341|NCT01960855|147590887|OTHER||||||=|0.028|||||||Chi-squared|||||||= 0.028
74019342|NCT01960855|147590888|OTHER||||||=|0.126|||||||Chi-squared|||||||= 0.126
74019343|NCT01960855|147590888|OTHER||||||=|0.072|||||||Chi-squared|||||||= 0.072
74019344|NCT01960855|147590888|OTHER||||||=|0.012|||||||Chi-squared|||||||= 0.012
74019345|NCT01960855|147590888|OTHER||||||=|0.021|||||||Chi-squared|||||||= 0.021
74019346|NCT02058147|147590889|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.898|-0.665||Threshold for significance ≤0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.||-0.665|-0.898|<0.0001
74019347|NCT02058147|147590889|NON_INFERIORITY_OR_EQUIVALENCE|Predefined non-inferiority margin of 0.3%.|LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.048|||TWO_SIDED|95.0|-0.384|-0.194|||Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.||-0.194|-0.384|
74019348|NCT02058147|147590889|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.384|-0.194||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Test of superiority was also performed as a secondary endpoint according to hierarchical testing procedure. Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction, as a covariate.||-0.194|-0.384|<0.0001
74019349|NCT02058147|147590890|SUPERIORITY_OR_OTHER||Difference in percentage|40.61|||<|0.0001|TWO_SIDED|95.0|33.63|47.59||Threshold for significance ≤0.05.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||47.59|33.63|<0.0001
74019350|NCT02058147|147590890|SUPERIORITY_OR_OTHER||Difference in percentage|36.38|||<|0.0001|TWO_SIDED|95.0|29.81|42.95||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||42.95|29.81|<0.0001
74019351|NCT02058147|147590890|SUPERIORITY_OR_OTHER||Difference in percentage|14.31|||<|0.0001|TWO_SIDED|95.0|8.37|20.25||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||20.25|8.37|<0.0001
74019352|NCT02058147|147590890|SUPERIORITY_OR_OTHER||Difference in percentage|16.35|||<|0.0001|TWO_SIDED|95.0|10.13|22.58||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||22.58|10.13|<0.0001
73881510|NCT03192176|147297634|SUPERIORITY||LSMean difference|1.7|STANDARD_ERROR_OF_MEAN|5.08||0.7422|TWO_SIDED|95.0|-8.33|11.68||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||11.68|-8.33|0.7422
73881511|NCT03192176|147297634|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|5.09||0.603|TWO_SIDED|95.0|-12.67|7.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||7.37|-12.67|0.6030
73881512|NCT03192176|147297634|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|5.14||0.2478|TWO_SIDED|95.0|-16.07|4.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||4.17|-16.07|0.2478
74051757|NCT01021293|147655936|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 2 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV||1.24|-1.28|
74051758|NCT01021293|147655936|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 3 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|-1.69|||||TWO_SIDED|95.0|-3.9|-0.44||||||Non-inferiority of Poliorix™ as compared to OPV||-0.44|-3.9|
74051759|NCT03521089|147655974|SUPERIORITY|||||||0.0039|||||||ANCOVA|||||||0.0039
74051760|NCT03521089|147655974|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
74051761|NCT03521089|147655974|SUPERIORITY|||||||0.0156|||||||Wilcoxon (Mann-Whitney)|||||||0.0156
74051762|NCT03521089|147655975|SUPERIORITY|||||||0.9674|||||||ANCOVA|||||||0.9674
74051763|NCT03521089|147655975|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
74051764|NCT03521089|147655975|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.2500
74051765|NCT03521089|147655976|SUPERIORITY|||||||0.0067|||||||ANCOVA|||||||0.0067
74051766|NCT03521089|147655976|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
74051767|NCT03521089|147655976|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.7500
74051768|NCT03521089|147655977|SUPERIORITY|||||||0.3069|||||||ANCOVA|||||||0.3069
74051769|NCT03521089|147655977|SUPERIORITY|||||||0.1875|||||||Wilcoxon (Mann-Whitney)|||||||0.1875
74051770|NCT03521089|147655977|SUPERIORITY|||||||0.7188|||||||Wilcoxon (Mann-Whitney)|||||||0.7188
74051771|NCT03521089|147655978|SUPERIORITY|||||||0.2609|||||||ANCOVA|||||||0.2609
74051772|NCT03521089|147655978|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
74051773|NCT03521089|147655978|SUPERIORITY|||||||0.0156|||||||Wilcoxon (Mann-Whitney)|||||||0.0156
74051774|NCT03521089|147655979|SUPERIORITY|||||||0.6951|||||||ANCOVA|||||||0.6951
74051775|NCT03521089|147655979|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
74051776|NCT03521089|147655979|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
74051777|NCT03521089|147655980|SUPERIORITY|||||||0.3592|||||||ANCOVA|||||||0.3592
74051778|NCT03521089|147655980|SUPERIORITY|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
74051779|NCT03521089|147655980|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
74099433|NCT01595386|147747962|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
74099434|NCT01595386|147747963|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
74099435|NCT01595386|147747964|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.7|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7
74099436|NCT01595386|147747965|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.76|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
74099437|NCT01595386|147747966|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.23|TWO_SIDED|95.0|||||Fisher Exact|||||||0.23
74099438|NCT01595386|147747967|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.|||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
74099439|NCT01595386|147747967|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.001|TWO_SIDED|95.0||||post-operative cortisol.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||<0.001
74099440|NCT01595386|147747967|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.004|TWO_SIDED|95.0||||Adrenal Insufficiency after bypass.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||0.004
74099441|NCT01595386|147747967|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.02|TWO_SIDED|95.0||||Development of Low cardiac output syndrome in subjects with Adrenal Insufficiency.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||0.02
74099442|NCT02952898|147747969|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of GDC 695 gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.||||<0.0001
74099443|NCT02952898|147747969|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of Diclofenac sodium gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.||||<0.0001
74051780|NCT05064449|147655987|OTHER||Geometric Mean Ratio (%)|116.59|||||TWO_SIDED|90.0|91.3|148.9|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90 percent (%) confidence intervals (CIs) for the geometric mean ratio (GMR) of Cmax for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed Cmax.||148.90|91.30|
74051781|NCT05064449|147655988|OTHER||Geometric Mean Ratio (%)|107.31|||||TWO_SIDED|90.0|88.02|130.83|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of Cmax for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed Cmax.||130.83|88.02|
74051782|NCT05064449|147655989|OTHER||Geometric Mean Ratio (%)|123.96|||||TWO_SIDED|90.0|106.21|144.68|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUC∞ for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.||144.68|106.21|
74051783|NCT05064449|147655990|OTHER||Geometric Mean Ratio (%)|100.57|||||TWO_SIDED|90.0|86.17|117.38|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUC∞ for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.||117.38|86.17|
74051784|NCT05064449|147655991|OTHER||Geometric Mean Ratio (%)|121.97|||||TWO_SIDED|90.0|103.47|143.79|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUClast for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.||143.79|103.47|
74051785|NCT05064449|147655992|OTHER||Geometric Mean Ratio (%)|107.38|||||TWO_SIDED|90.0|91.68|125.77|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUClast for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.||125.77|91.68|
74051786|NCT05064449|147655993|OTHER||Median Difference (Final Values)|0.003|||=|0.2305|TWO_SIDED|90.0|-0.001|0.126|||Wilcoxon Signed Rank Test||Difference was calculated as (Soticlestat + Itraconazole) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% CI was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.126|-0.001|=0.2305
74051787|NCT05064449|147655994|OTHER||Median Difference (Final Values)|-0.096|||=|0.583|TWO_SIDED|90.0|-0.128|0.018|||Wilcoxon Signed Rank Test||Difference was calculated as (Soticlestat + Mefenamic Acid) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.018|-0.128|=0.5830
74051788|NCT00542321|147656004|SUPERIORITY_OR_OTHER||difference between proportions|0.5||||1|TWO_SIDED|95.0|||||Fisher Exact|Chi-Square = 0.750, df = 1||Pearson Chi-Square Test for difference between groups||||1.00
74051789|NCT00542321|147656005|SUPERIORITY_OR_OTHER||Rank sums|52.0||||1|TWO_SIDED|95.0||||Alpha = .05|Wilcoxon (Mann-Whitney)|||There will be no difference in duration of mechanical ventilation between groups.||||1.0
74051790|NCT00542321|147656006|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.451
74099444|NCT04123561|147747981|SUPERIORITY|"The primary efficacy endpoint is defined as the change from Injection 1 Baseline in WOMAC Pain on a normalized scale of 0-4 at Week 12 between the randomized TLC599 12mg and Placebo groups.~The least-squares mean, alongside its corresponding 95% confidence interval, was used to estimate the treatment difference between TLC599 and Placebo, utilizing two-sided p-values."|Least Squares Mean Difference (LSMD)|-0.171|STANDARD_ERROR_OF_MEAN|0.0819||0.0372|TWO_SIDED|95.0|-0.331|-0.01|||ANCOVA|Parameters estimated via REML using the Newton-Raphson algorithm, and the Kenward-Roger method calculates denominator degrees of freedom.||||-0.010|-0.331|0.0372
74099445|NCT03462459|147748006|EQUIVALENCE|Proportional tests (Chi-squared) compared the episodes of C. difficile. Log-rank tests (Kaplan-Meier) were conducted to compare the non-recurrence proportions within the eight-week period. Multivariate Cox proportional hazard regression determined if treatment, age, and number of previous C. difficile episodes were predictors of recurrence.|See comments|-0.11||||0.22|TWO_SIDED|95.0|-35.1|8.0|||Chi-squared||Proportional tests compared episodes of C. difficile recurrence in eight weeks (vancomycin vs. placebo) using Chi-squared test. Log-rank tests compared the non-recurrence proportions within 8 weeks with the Kaplan-Meier method.||"Statistical analyses are primarily reported for the population who were randomized in the study (as randomized). The secondary statistical analyses are reported for the population who completed all three visits (as completed treatment). Proportional tests were conducted to compare the episodes of C. difficile recurrence in eight weeks following the completion of the study intervention in patients receiving vancomycin versus placebo using the Chi-squared test. Log-rank tests were conducted to compare the non-recurrence proportions within the eight-week period in patients receiving vancomycin versus placebo with the Kaplan-Meier method. A nonparametric Wilcoxon rank sum test was used to compare distributions of the number of days to the first recurrence of CDI after starting oral vancomycin or placebo. The significance level was set to be ≤0.05. All statistical analyses were conducted in R statistical software (version 4.4.0; R Core Team, 2024)"|8.0|-35.1|0.22
74099446|NCT03462459|147748008|EQUIVALENCE|Proportional difference tests comparing the proportion of patients with VRE colonization at Visit 3, compared to baseline. Significance level was set to 0.10.||||||0.1|||||||Proportional difference test|||||||0.10
74051791|NCT00542321|147656007|SUPERIORITY_OR_OTHER||probability|0.43||||1||95.0|||||Fisher Exact|||||||1.0
74051792|NCT00542321|147656008|SUPERIORITY_OR_OTHER||Rank sums|56.0||||1|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0
74051793|NCT04138758|147656013|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.85|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of a first COPD exacerbation.||0.85|0.68|
74051794|NCT04138758|147656014|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.57|0.97|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of first hospitalization for community-acquired pneumonia.||0.97|0.57|
74051795|NCT04138758|147656015|OTHER|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of escalation.|Hazard Ratio (HR)|0.23|||||TWO_SIDED|95.0|0.19|0.27|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|||0.27|0.19|
74051796|NCT04138758|147656016|OTHER||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.19|0.26|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of escalation.||0.26|0.19|
74051797|NCT04138758|147656017|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.42|0.51|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation.||0.51|0.42|
74051798|NCT04138758|147656018|OTHER||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.41|0.49|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation.||0.49|0.41|
74099447|NCT00270855|147748016|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group (i.e, baseline vs. post-intervention in ARE)||||>0.05
74099448|NCT00270855|147748016|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group (i.e, baseline vs. post-intervention in FESLCE)||||>0.05
74051799|NCT00608426|147656044|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Logistic|||||||.02
74051800|NCT00608426|147656045|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||for the comparison of telephone counseling between the two groups|Mixed effects logistic regression|||||||<.001
74051801|NCT00608426|147656045|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|||||for the comparison of in-person counseling between the two groups|Mixed effects logistic regression|||||||0.57
74051802|NCT00608426|147656045|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||for the comparison of used medications between the two groups|Mixed effects logistic regression|||||||.15
74051803|NCT00608426|147656045|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||for the comparison of combination counseling and medication between the two groups|Mixed effects logistic regression|||||||<.001
74051804|NCT00608426|147656045|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED|||||for the comparison of attended VA smoking cessation clinic between the two groups|Mixed effects logistic regression|||||||.77
74051805|NCT00608426|147656045|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||for the comparison of received VA smoking cessation medication between the two groups|Mixed effects logistic regression|||||||.002
74051806|NCT00608426|147656046|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Regression, Logistic|||||||0.13
74099449|NCT00270855|147748017|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
74099450|NCT00270855|147748017|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
74099451|NCT00270855|147748018|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.||||||0.519|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group.||||0.519
74099452|NCT00270855|147748018|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
74051807|NCT02630459|147656069|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.58|-1.2||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.20|-2.58|<0.001
74051808|NCT02630459|147656069|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.31|||<|0.001|TWO_SIDED|95.0|-3.0|-1.62||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.62|-3.00|<0.001
74051809|NCT02630459|147656069|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.25||||0.004|TWO_SIDED|95.0|-2.1|-0.41||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-0.41|-2.10|0.004
74051810|NCT02630459|147656070|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.3|13.8|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Full Administration||13.8|-13.3|
74051811|NCT02630459|147656070|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Not Full Administration||13.3|-13.8|
74051812|NCT02630459|147656070|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Discontinued Investigational Product||13.3|-13.8|
74051813|NCT02630459|147656070|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.3|13.8|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Full Administration||13.8|-13.3|
74051814|NCT02630459|147656070|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Not Full Administration||13.3|-13.8|
74051815|NCT02630459|147656070|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Discontinued Investigational Product||13.3|-13.8|
74099453|NCT00270855|147748019|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.||||||0.615|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||0.615
74099454|NCT00270855|147748019|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
74099455|NCT00270855|147748020|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
74099456|NCT00270855|147748020|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
74051816|NCT02630459|147656071|SUPERIORITY||Common Odds Ratio|4.73|||<|0.001|TWO_SIDED|95.0|2.24|9.99||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||9.99|2.24|<0.001
74051817|NCT02630459|147656071|SUPERIORITY||Common Odds Ratio|5.6|||<|0.001|TWO_SIDED|95.0|2.6|12.06||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||12.06|2.60|<0.001
74051818|NCT02630459|147656071|SUPERIORITY||Common Odds Ratio|3.21||||0.009|TWO_SIDED|95.0|1.3|7.88||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||7.88|1.30|0.009
74051819|NCT02630459|147656072|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.04|||<|0.001|TWO_SIDED|95.0|-2.63|-1.45||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.45|-2.63|<0.001
74051820|NCT02630459|147656072|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.07|||<|0.001|TWO_SIDED|95.0|-2.66|-1.49||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.49|-2.66|<0.001
74099457|NCT00270855|147748021|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
74099458|NCT00270855|147748022|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
74099459|NCT00270855|147748023|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
73881513|NCT03192176|147297634|SUPERIORITY||LSMean difference|3.3|STANDARD_ERROR_OF_MEAN|5.18||0.5295|TWO_SIDED|95.0|-6.94|13.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||13.47|-6.94|0.5295
73881514|NCT03192176|147297634|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|5.16||0.6938|TWO_SIDED|95.0|-12.2|8.13||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||8.13|-12.20|0.6938
74051821|NCT02630459|147656072|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.07||||0.004|TWO_SIDED|95.0|-1.8|-0.35||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-0.35|-1.80|0.004
74051822|NCT00125138|147656081|SUPERIORITY_OR_OTHER||Difference of LS Mean|0.1||||0.5177|TWO_SIDED|95.0|-6.3|6.6||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||6.6|-6.3|0.5177
74051823|NCT00125138|147656081|SUPERIORITY_OR_OTHER||Difference of LS mean|-2.9||||0.1519|TWO_SIDED|95.0|-8.5|2.7||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||2.7|-8.5|0.1519
74051824|NCT00125138|147656081|SUPERIORITY_OR_OTHER||Difference of LS mean|0.3||||0.5406|TWO_SIDED|95.0|-5.2|5.8||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||5.8|-5.2|0.5406
74051825|NCT00125138|147656082|SUPERIORITY_OR_OTHER|||||||0.9212||95.0||||Overall p-value using a one-way ANCOVA.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||Only subjects with both a baseline and a post-baseline value are included.||||0.9212
74051826|NCT00041119|147656090|SUPERIORITY|If the 5-year DFS for 4 cycles is 84.7% then a decrease of 23% in hazard rate for 6 cycles corresponds to an increase in 5-year DFS to 88%. Assuming a 2-sided significance level of 0.05, there is 90.9% power to detect such an increase at the final analysis conducted 6.4 years after study activation.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.84|1.28||||||The null hypothesis is that the hazards of both 6 and 4 cycle regimens are equal. The alternative hypothesis is a hazard ratio of 0.77, corresponding to a decrease of 23% in hazard due to longer duration of chemotherapy.||1.28|0.84|
74051827|NCT00041119|147656091|EQUIVALENCE|For T to be considered equivalent to the standard CA, a confidence interval of the hazard ratio of T to CA should be wholly to the left of 1.3, corresponding to a 30% increase in hazard rate. If the 5-year DFS for CA is 88% then an increase of 30% in hazard rate for T corresponds to 5-year DFS of 84.7%. The null hypothesis is that the hazard ratio of T to CA exceeds 1.3. The alternative hypothesis is that the two hazard rates are equivalent.|Hazard Ratio (HR)|1.26|||||ONE_SIDED|95.0||1.48||||||||1.48||
74051828|NCT00041119|147656092|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years. We assume the 5-year DFS of CA therapy is 88% and 84.7% for T. These assumptions are based upon results of SWOG 8897.|Hazard Ratio (HR)|1.27|||||ONE_SIDED|95.0||1.56||||||||1.56||
74051829|NCT00041119|147656096|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.84|1.49||||||||1.49|.84|
74051830|NCT01258738|147656103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.64||||0.0062|TWO_SIDED|95.0|5.36|27.92||P-value \<0.05 was required to declare statistical significance.|Cochran-Mantel-Haenszel|||"The null hypothesis was that the efficacy of etanercept was not different from placebo as measured by the proportion of subjects achieving an ASAS 40 response after 12 weeks of treatment. The alternative hypothesis was that the efficacy of etanercept was different from placebo.~The primary endpoint was tested at 2-sided alpha = 0.05 significance level. Comparative analysis was carried out for Week 12 data only."||27.92|5.36|0.0062
74099460|NCT00270855|147748024|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
73881515|NCT03192176|147297634|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|4.97||0.9765|TWO_SIDED|95.0|-9.93|9.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||9.63|-9.93|0.9765
74051831|NCT01258738|147656104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.46||||0.0059|TWO_SIDED|95.0|3.69|19.24|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||19.24|3.69|0.0059
74051832|NCT01258738|147656104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19||||0.3786|TWO_SIDED|95.0|-4.98|15.35|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4"||15.35|-4.98|0.3786
74051833|NCT01258738|147656104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.83||||0.0304|TWO_SIDED|95.0|1.79|23.87|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||23.87|1.79|0.0304
74051834|NCT01258738|147656104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.52||||0.0023|TWO_SIDED|95.0|7.29|29.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||29.75|7.29|0.0023
74051835|NCT01258738|147656105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.44||||0.0189|TWO_SIDED|95.0|3.2|25.68|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||25.68|3.20|0.0189
74051836|NCT01258738|147656105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.29||||0.0983|TWO_SIDED|95.0|-2.17|22.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||22.75|-2.17|0.0983
74051837|NCT01258738|147656105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.61||||0.0867|TWO_SIDED|95.0|-2.63|23.84|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||23.84|-2.63|0.0867
74099461|NCT00270855|147748025|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
74099462|NCT00270855|147748026|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
74099463|NCT00270855|147748026|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
74051838|NCT01258738|147656105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.27||||0.0195|TWO_SIDED|95.0|3.1|29.43|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||29.43|3.10|0.0195
74051839|NCT01258738|147656106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.63|||<|0.0001|TWO_SIDED|95.0|11.85|33.41|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||33.41|11.85|<0.0001
74051840|NCT01258738|147656106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.83||||0.0021|TWO_SIDED|95.0|5.09|20.57|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||20.57|5.09|0.0021
74099464|NCT00270855|147748027|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
74099465|NCT00270855|147748027|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
74099466|NCT00270855|147748028|NON_INFERIORITY_OR_EQUIVALENCE|Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
74099467|NCT00270855|147748028|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
74051841|NCT01258738|147656106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.89||||0.002|TWO_SIDED|95.0|5.18|24.6|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||24.60|5.18|0.0020
74051842|NCT01258738|147656106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.79|||<|0.0001|TWO_SIDED|95.0|10.92|32.67|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||32.67|10.92|<0.0001
74051843|NCT01258738|147656107|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051844|NCT01258738|147656107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.74|-0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.34|-0.74|<0.001
74099468|NCT00270855|147748029|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
74051845|NCT01258738|147656107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.81|-0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.41|-0.81|<0.001
74051846|NCT01258738|147656107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.85|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.37|-0.85|<0.001
74051847|NCT01258738|147656108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.84||||0.0209|TWO_SIDED|95.0|2.58|23.09|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||23.09|2.58|0.0209
74051848|NCT01258738|147656108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.65||||0.0179|TWO_SIDED|95.0|1.82|15.48|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.~Week 2"||15.48|1.82|0.0179
74051849|NCT01258738|147656108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.81||||0.0611|TWO_SIDED|95.0|-0.03|13.65|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||13.65|-0.03|0.0611
74051850|NCT01258738|147656108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.73||||0.0141|TWO_SIDED|95.0|3.14|22.32|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||22.32|3.14|0.0141
74051851|NCT01258738|147656108|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051852|NCT01258738|147656109|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||Log Rank|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."||||0.0022
74051853|NCT01258738|147656110|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051854|NCT01258738|147656110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0156|TWO_SIDED|95.0|-1.26|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.13|-1.26|0.0156
74051855|NCT01258738|147656110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0111|TWO_SIDED|95.0|-1.06|-0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.14|-1.06|0.0111
74051856|NCT01258738|147656110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0936|TWO_SIDED|95.0|-0.91|0.07|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.07|-0.91|0.0936
74099469|NCT00270855|147748029|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
74099470|NCT00270855|147748030|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
74051857|NCT01258738|147656110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.2678|TWO_SIDED|95.0|-0.81|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.23|-0.81|0.2678
74051858|NCT01258738|147656111|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results included unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051859|NCT01258738|147656111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0102|TWO_SIDED|95.0|-1.4|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.19|-1.40|0.0102
74051860|NCT01258738|147656111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.0007|TWO_SIDED|95.0|-1.44|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.39|-1.44|0.0007
74099471|NCT00270855|147748030|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
74051861|NCT01258738|147656111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0057|TWO_SIDED|95.0|-1.35|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.23|-1.35|0.0057
74051862|NCT01258738|147656111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0077|TWO_SIDED|95.0|-1.44|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.22|-1.44|0.0077
74051863|NCT01258738|147656112|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74099472|NCT00270855|147748031|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
74099473|NCT00270855|147748031|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
74099474|NCT00270855|147748032|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
74099475|NCT00270855|147748032|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
74099476|NCT00270855|147748033|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
74051864|NCT01258738|147656112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.0091|TWO_SIDED|95.0|-1.62|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.23|-1.62|0.0091
74051865|NCT01258738|147656112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0097|TWO_SIDED|95.0|-1.38|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.19|-1.38|0.0097
74051866|NCT01258738|147656112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0101|TWO_SIDED|95.0|-1.45|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.20|-1.45|0.0101
74051867|NCT01258738|147656112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.0031|TWO_SIDED|95.0|-1.61|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.33|-1.61|0.0031
74051868|NCT01258738|147656113|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051869|NCT01258738|147656113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.0064|TWO_SIDED|95.0|-1.49|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.25|-1.49|0.0064
74051870|NCT01258738|147656113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0407|TWO_SIDED|95.0|-1.12|-0.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.02|-1.12|0.0407
74099477|NCT00270855|147748034|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
74099478|NCT00270855|147748035|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
74099479|NCT00270855|147748036|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
74099480|NCT00270855|147748037|OTHER|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
74051871|NCT01258738|147656113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.0349|TWO_SIDED|95.0|-1.24|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.05|-1.24|0.0349
74051872|NCT01258738|147656113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.0021|TWO_SIDED|95.0|-1.65|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.37|-1.65|0.0021
74051873|NCT01258738|147656114|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051874|NCT01258738|147656114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0164|TWO_SIDED|95.0|-1.04|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.11|-1.04|0.0164
74051875|NCT01258738|147656114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0095|TWO_SIDED|95.0|-0.95|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.13|-0.95|0.0095
74051876|NCT01258738|147656114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0127|TWO_SIDED|95.0|-0.99|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.12|-0.99|0.0127
74051877|NCT01258738|147656114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0166|TWO_SIDED|95.0|-0.99|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.10|-0.99|0.0166
74051878|NCT01258738|147656115|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051879|NCT01258738|147656115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.0029|TWO_SIDED|95.0|-1.28|-0.27|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.27|-1.28|0.0029
74051880|NCT01258738|147656115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0147|TWO_SIDED|95.0|-1.21|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.13|-1.21|0.0147
74051881|NCT01258738|147656115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0056|TWO_SIDED|95.0|-1.28|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.22|-1.28|0.0056
74051882|NCT01258738|147656115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.001|TWO_SIDED|95.0|-1.52|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.39|-1.52|0.0010
74051883|NCT01258738|147656116|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051884|NCT01258738|147656116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0173|TWO_SIDED|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.12|-1.19|0.0173
74051885|NCT01258738|147656116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1618|TWO_SIDED|95.0|-0.97|0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.16|-0.97|0.1618
74051886|NCT01258738|147656116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.0153|TWO_SIDED|95.0|-1.25|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.13|-1.25|0.0153
74051887|NCT01258738|147656116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0866|TWO_SIDED|95.0|-1.05|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.07|-1.05|0.0866
74051888|NCT01258738|147656117|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051889|NCT01258738|147656117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.1413|TWO_SIDED|95.0|-0.95|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.14|-0.95|0.1413
74051890|NCT01258738|147656117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0284|TWO_SIDED|95.0|-1.14|-0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.06|-1.14|0.0284
74051891|NCT01258738|147656117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.0659|TWO_SIDED|95.0|-1.07|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.03|-1.07|0.0659
74099481|NCT00270855|147748038|NON_INFERIORITY_OR_EQUIVALENCE|We used a Mann-Whitney U test.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||we evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
74051892|NCT01258738|147656117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.0098|TWO_SIDED|95.0|-1.26|-0.18|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.18|-1.26|0.0098
74051893|NCT01258738|147656118|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051894|NCT01258738|147656118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0037|TWO_SIDED|95.0|-1.26|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.25|-1.26|0.0037
74051895|NCT01258738|147656118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0044|TWO_SIDED|95.0|-1.35|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.25|-1.35|0.0044
74099482|NCT00270855|147748039|NON_INFERIORITY_OR_EQUIVALENCE|A mann-whitney u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
74051896|NCT01258738|147656118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0104|TWO_SIDED|95.0|-1.26|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.17|-1.26|0.0104
74099483|NCT00270855|147748040|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
74099484|NCT00270855|147748040|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
73881516|NCT03192176|147297634|SUPERIORITY||LSMean difference|3.7|STANDARD_ERROR_OF_MEAN|5.13||0.4771|TWO_SIDED|95.0|-6.45|13.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||13.76|-6.45|0.4771
74051897|NCT01258738|147656118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.006|TWO_SIDED|95.0|-1.33|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.22|-1.33|0.0060
74051898|NCT01258738|147656119|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051899|NCT01258738|147656119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.2268|TWO_SIDED|95.0|-0.8|0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.19|-0.80|0.2268
74051900|NCT01258738|147656119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1145|TWO_SIDED|95.0|-0.93|0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.10|-0.93|0.1145
74051901|NCT01258738|147656119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0512|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.00|-1.00|0.0512
74099485|NCT00270855|147748041|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
74099486|NCT02755649|147748064|SUPERIORITY||Difference in Percentages|29.5|||<|0.0001|TWO_SIDED|95.0|16.87|42.05||Threshold for significance at 0.05 level. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by disease severity (IGA 3 vs IGA 4) and prior Cyclosporine A (CSA) use (Yes, No).|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across 2 dose regimens. Difference is Dupilumab minus placebo. Confidence Interval (CI) calculated using normal approximation. Participants with missing values at Week 16 were categorized as non-responders at Week 16. Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated.||42.05|16.87|< 0.0001
74099487|NCT02755649|147748064|SUPERIORITY||difference in percentages|33.0|||<|0.0001|TWO_SIDED|95.0|20.41|45.57||Threshold for significance at 0.05 level. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by disease severity (IGA 3 vs IGA 4) and prior Cyclosporine A (CSA) use (Yes, No).|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across 2 dose regimens. Difference is Dupilumab minus placebo. Confidence Interval (CI) calculated using normal approximation. Participants with missing values at Week 16 were categorized as non-responders at Week 16. Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated.||45.57|20.41|< 0.0001
74051902|NCT01258738|147656119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.0509|TWO_SIDED|95.0|-1.02|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.00|-1.02|0.0509
74051903|NCT01258738|147656120|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051904|NCT01258738|147656120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.243|TWO_SIDED|95.0|-0.79|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.20|-0.79|0.2430
74051905|NCT01258738|147656120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0384|TWO_SIDED|95.0|-1.09|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.03|-1.09|0.0384
74051906|NCT01258738|147656120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0797|TWO_SIDED|95.0|-1.03|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.06|-1.03|0.0797
74051907|NCT01258738|147656120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.2186|TWO_SIDED|95.0|-0.9|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.21|-0.90|0.2186
74051908|NCT01258738|147656121|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051909|NCT01258738|147656121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.141|TWO_SIDED|95.0|-0.96|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.14|-0.96|0.1410
74051910|NCT01258738|147656121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2299|TWO_SIDED|95.0|-0.88|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.21|-0.88|0.2299
74051911|NCT01258738|147656121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.3221|TWO_SIDED|95.0|-0.87|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.29|-0.87|0.3221
74051912|NCT01258738|147656121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1891|TWO_SIDED|95.0|-0.99|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.20|-0.99|0.1891
74051913|NCT01258738|147656122|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051914|NCT01258738|147656122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.108|TWO_SIDED|95.0|-0.9|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.09|-0.90|0.1080
74051915|NCT01258738|147656122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0389|TWO_SIDED|95.0|-1.06|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.03|-1.06|0.0389
74051916|NCT01258738|147656122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.1181|TWO_SIDED|95.0|-0.98|0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.11|-0.98|0.1181
74051917|NCT01258738|147656122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.2271|TWO_SIDED|95.0|-0.94|0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.22|-0.94|0.2271
74051918|NCT01258738|147656123|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051919|NCT01258738|147656123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0044|TWO_SIDED|95.0|-1.27|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.24|-1.27|0.0044
74051920|NCT01258738|147656123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0455|TWO_SIDED|95.0|-1.09|-0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.01|-1.09|0.0455
74051921|NCT01258738|147656123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.175|TWO_SIDED|95.0|-0.91|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.17|-0.91|0.1750
74051922|NCT01258738|147656123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.0379|TWO_SIDED|95.0|-1.12|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.03|-1.12|0.0379
74051923|NCT01258738|147656124|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051924|NCT01258738|147656124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0826|TWO_SIDED|95.0|-0.98|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.06|-0.98|0.0826
74051925|NCT01258738|147656124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1538|TWO_SIDED|95.0|-0.96|0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.15|-0.96|0.1538
74099488|NCT02755649|147748065|SUPERIORITY||Least square (LS) mean difference|-31.6|||<|0.0001|TWO_SIDED|95.0|-38.85|-24.3||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach to control Type-1 error rate at 0.05 across 2 dose regimens.CI w/p-value based on treatment difference(dupilumab vs placebo) of LS mean percent change using multiple imputation (MI) w/ANCOVA model w/baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use\[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-24.3|-38.85|< 0.0001
74099489|NCT02755649|147748065|SUPERIORITY||LS Mean Difference|-33.1|||<|0.0001|TWO_SIDED|95.0|-40.42|-25.88||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue \& then imputed by MI.||-25.88|-40.42|< 0.0001
74099490|NCT02755649|147748066|SUPERIORITY||LS mean difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-35.07|-17.41||Threshold for significance at 0.05 level.|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-17.41|-35.07|< 0.0001
73881517|NCT03192176|147297634|SUPERIORITY||LSMean difference|3.5|STANDARD_ERROR_OF_MEAN|4.44||0.4256|TWO_SIDED|95.0|-5.19|12.27||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||12.27|-5.19|0.4256
74051926|NCT01258738|147656124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0728|TWO_SIDED|95.0|-1.04|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.05|-1.04|0.0728
74051927|NCT01258738|147656124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0975|TWO_SIDED|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.08|-0.99|0.0975
74051928|NCT01258738|147656125|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051929|NCT01258738|147656125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0186|TWO_SIDED|95.0|-1.18|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.11|-1.18|0.0186
74051930|NCT01258738|147656125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0106|TWO_SIDED|95.0|-1.01|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.13|-1.01|0.0106
74099491|NCT02755649|147748066|SUPERIORITY||LS Mean Difference]|-28.5|||<|0.0001|TWO_SIDED|95.0|-37.34|-19.68||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-19.68|-37.34|< 0.0001
74099492|NCT02755649|147748067|SUPERIORITY||LS Mean Difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.56|-21.93||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-21.93|-35.56|< 0.0001
74099493|NCT02755649|147748067|SUPERIORITY||LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-39.7|-26.06||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-26.06|-39.7|< 0.0001
74051931|NCT01258738|147656125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0048|TWO_SIDED|95.0|-1.11|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.20|-1.11|0.0048
74051932|NCT01258738|147656125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0016|TWO_SIDED|95.0|-1.31|-0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.31|-1.31|0.0016
74051933|NCT01258738|147656126|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051934|NCT01258738|147656126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0058|TWO_SIDED|95.0|-1.37|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.24|-1.37|0.0058
74051935|NCT01258738|147656126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0064|TWO_SIDED|95.0|-1.42|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.24|-1.42|0.0064
74051936|NCT01258738|147656126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.0002|TWO_SIDED|95.0|-1.85|-0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.60|-1.85|0.0002
74051937|NCT01258738|147656126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0134|TWO_SIDED|95.0|-1.49|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.17|-1.49|0.0134
74051938|NCT01258738|147656127|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051939|NCT01258738|147656127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0316|TWO_SIDED|95.0|-1.09|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.05|-1.09|0.0316
74051940|NCT01258738|147656127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0973|TWO_SIDED|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.08|-0.99|0.0973
74051941|NCT01258738|147656127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0216|TWO_SIDED|95.0|-1.27|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.10|-1.27|0.0216
74051942|NCT01258738|147656127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.2425|TWO_SIDED|95.0|-1.03|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.26|-1.03|0.2425
74051943|NCT01258738|147656128|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051944|NCT01258738|147656128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2688|TWO_SIDED|95.0|-0.92|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.26|-0.92|0.2688
74051945|NCT01258738|147656128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0866|TWO_SIDED|95.0|-1.17|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.08|-1.17|0.0866
74099494|NCT02755649|147748068|SUPERIORITY||difference in percentages|26.1|||<|0.0001|TWO_SIDED|95.0|13.89|38.39||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||38.39|13.89|< 0.0001
74051946|NCT01258738|147656128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0277|TWO_SIDED|95.0|-1.34|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.08|-1.34|0.0277
74051947|NCT01258738|147656128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.239|TWO_SIDED|95.0|-1.04|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.26|-1.04|0.2390
74051948|NCT01258738|147656129|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051949|NCT01258738|147656129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0928|TWO_SIDED|95.0|-1.0|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.08|-1.00|0.0928
74051950|NCT01258738|147656129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0139|TWO_SIDED|95.0|-1.27|-0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.15|-1.27|0.0139
74051951|NCT01258738|147656129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0017|TWO_SIDED|95.0|-1.53|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.36|-1.53|0.0017
74051952|NCT01258738|147656129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.0008|TWO_SIDED|95.0|-1.61|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.43|-1.61|0.0008
74051953|NCT01258738|147656130|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051954|NCT01258738|147656130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.4559|TWO_SIDED|95.0|-0.84|0.38|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.38|-0.84|0.4559
74051955|NCT01258738|147656130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0345|TWO_SIDED|95.0|-1.28|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.05|-1.28|0.0345
74051956|NCT01258738|147656130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.034|TWO_SIDED|95.0|-1.3|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.05|-1.30|0.0340
74051957|NCT01258738|147656130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0634|TWO_SIDED|95.0|-1.24|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.03|-1.24|0.0634
74051958|NCT01258738|147656131|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051959|NCT01258738|147656131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.0007|TWO_SIDED|95.0|-1.56|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.43|-1.56|0.0007
74051960|NCT01258738|147656131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0073|TWO_SIDED|95.0|-1.39|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.22|-1.39|0.0073
74051961|NCT01258738|147656131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.0094|TWO_SIDED|95.0|-1.48|-0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.21|-1.48|0.0094
74051962|NCT01258738|147656131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.012|TWO_SIDED|95.0|-1.54|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.19|-1.54|0.0120
74051963|NCT01258738|147656132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.96||||0.0029|TWO_SIDED|95.0|7.54|32.37|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||32.37|7.54|0.0029
74051964|NCT01258738|147656132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.59||||0.01|TWO_SIDED|95.0|3.18|19.99|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||19.99|3.18|0.0100
74051965|NCT01258738|147656132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.75||||0.012|TWO_SIDED|95.0|3.62|23.89|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||23.89|3.62|0.0120
74051966|NCT01258738|147656132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.12||||0.0213|TWO_SIDED|95.0|3.04|27.2|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||27.20|3.04|0.0213
74051967|NCT01258738|147656133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.88||||0.2755|TWO_SIDED|95.0|-5.15|20.92|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||20.92|-5.15|0.2755
74051968|NCT01258738|147656133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.57||||0.195|TWO_SIDED|95.0|-4.39|21.54|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||21.54|-4.39|0.1950
74051969|NCT01258738|147656133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.99||||0.0278|TWO_SIDED|95.0|0.72|27.26|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||27.26|0.72|0.0278
74051970|NCT01258738|147656133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.29||||0.0174|TWO_SIDED|95.0|2.28|28.3|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||28.30|2.28|0.0174
74051971|NCT01258738|147656134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74099495|NCT02755649|147748068|SUPERIORITY||difference in percentages|31.5|||<|0.0001|TWO_SIDED|95.0|19.08|43.83||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||43.83|19.08|< 0.0001
74051972|NCT01258738|147656134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0201|TWO_SIDED|95.0|-0.99|-0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 4||-0.09|-0.99|0.0201
74051973|NCT01258738|147656134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0558|TWO_SIDED|95.0|-1.02|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 12||0.01|-1.02|0.0558
74051974|NCT01258738|147656135|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051975|NCT01258738|147656135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.6741|TWO_SIDED|95.0|-0.18|0.28|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.28|-0.18|0.6741
74051976|NCT01258738|147656135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3896|TWO_SIDED|95.0|-0.33|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.13|-0.33|0.3896
74051977|NCT01258738|147656135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.7468|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.31|-0.22|0.7468
74099496|NCT02755649|147748069|SUPERIORITY||LS Mean Difference|-17.95|||<|0.0001|TWO_SIDED|95.0|-22.706|-13.197||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value is based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment,randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-13.197|-22.706|< 0.0001
74099497|NCT02755649|147748069|SUPERIORITY||LS Mean Difference|-19.66|||<|0.0001|TWO_SIDED|95.0|-24.431|-14.895||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-14.895|-24.431|< 0.0001
74051978|NCT01258738|147656135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.6871|TWO_SIDED|95.0|-0.35|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.23|-0.35|0.6871
74051979|NCT01258738|147656136|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051980|NCT01258738|147656136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.4332|TWO_SIDED|95.0|-0.57|1.32|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||1.32|-0.57|0.4332
74051981|NCT01258738|147656136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9947|TWO_SIDED|95.0|-0.98|0.98|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.98|-0.98|0.9947
74051982|NCT01258738|147656136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.1558|TWO_SIDED|95.0|-0.28|1.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||1.75|-0.28|0.1558
74051983|NCT01258738|147656136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21||||0.0488|TWO_SIDED|95.0|0.03|2.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||2.39|0.03|0.0488
74051984|NCT01258738|147656137|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051985|NCT01258738|147656137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.7645|TWO_SIDED|95.0|-2.06|2.8|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||2.80|-2.06|0.7645
74051986|NCT01258738|147656137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.4178|TWO_SIDED|95.0|-1.48|3.55|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||3.55|-1.48|0.4178
74051987|NCT01258738|147656137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.443|TWO_SIDED|95.0|-1.67|3.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||3.79|-1.67|0.4430
74051988|NCT01258738|147656137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39||||0.1095|TWO_SIDED|95.0|-0.54|5.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||5.31|-0.54|0.1095
74051989|NCT01258738|147656138|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051990|NCT01258738|147656138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9504|TWO_SIDED|95.0|-0.46|0.49|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.49|-0.46|0.9504
74051991|NCT01258738|147656138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.4971|TWO_SIDED|95.0|-0.7|0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.34|-0.70|0.4971
74051992|NCT01258738|147656138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8999|TWO_SIDED|95.0|-0.47|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.54|-0.47|0.8999
74051993|NCT01258738|147656138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9712|TWO_SIDED|95.0|-0.6|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.62|-0.60|0.9712
74051994|NCT01258738|147656139|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74051995|NCT01258738|147656139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.4556|TWO_SIDED|95.0|-1.46|3.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||3.24|-1.46|0.4556
74051996|NCT01258738|147656139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85||||0.0543|TWO_SIDED|95.0|-0.05|5.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||5.75|-0.05|0.0543
74051997|NCT01258738|147656139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26||||0.1754|TWO_SIDED|95.0|-1.02|5.53|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||5.53|-1.02|0.1754
74051998|NCT01258738|147656139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45||||0.3985|TWO_SIDED|95.0|-1.93|4.82|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||4.82|-1.93|0.3985
74051999|NCT01258738|147656140|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74052000|NCT01258738|147656140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.2823|TWO_SIDED|95.0|-0.18|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.62|-0.18|0.2823
74052001|NCT01258738|147656140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.4029|TWO_SIDED|95.0|-0.23|0.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.58|-0.23|0.4029
74052002|NCT01258738|147656140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.511|TWO_SIDED|95.0|-0.25|0.51|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.51|-0.25|0.5110
74052003|NCT01258738|147656140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.5844|TWO_SIDED|95.0|-0.32|0.56|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.56|-0.32|0.5844
74099498|NCT02755649|147748070|SUPERIORITY||Difference in Percentages|25.2|||<|0.0001|TWO_SIDED|95.0|13.99|36.41||Threshold for significance at 0.05 level|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||36.41|13.99|< 0.0001
74099499|NCT02755649|147748070|SUPERIORITY||Difference in Percentages|26.3|||<|0.0001|TWO_SIDED|95.0|14.95|37.65||Threshold for significance at 0.05 level|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||37.65|14.95|< 0.0001
74099500|NCT02755649|147748071|SUPERIORITY||LS Mean Difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-5.6|-3.04||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.04|-5.6|< 0.0001
74099501|NCT02755649|147748071|SUPERIORITY||LS Mean Difference|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.31|-3.74||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.74|-6.31|< 0.0001
74099502|NCT02755649|147748072|SUPERIORITY||LS Mean Difference|-7.1|||<|0.0001|TWO_SIDED|95.0|-8.78|-5.47||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.47|-8.78|< 0.0001
74099503|NCT02755649|147748072|SUPERIORITY||LS Mean Difference|-7.6|||<|0.0001|TWO_SIDED|95.0|-9.29|-5.97||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.97|-9.29|< 0.0001
74052004|NCT01258738|147656141|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74052005|NCT01258738|147656141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0129|TWO_SIDED|95.0|-0.95|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.11|-0.95|0.0129
74052006|NCT01258738|147656141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.6003|TWO_SIDED|95.0|-0.61|0.35|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.35|-0.61|0.6003
74052007|NCT01258738|147656141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0911|TWO_SIDED|95.0|-0.89|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.07|-0.89|0.0911
74052008|NCT01258738|147656141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.3144|TWO_SIDED|95.0|-0.73|0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.24|-0.73|0.3144
74052009|NCT01258738|147656142|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74052010|NCT01258738|147656142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.6476|TWO_SIDED|95.0|-0.46|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 2||0.29|-0.46|0.6476
74052011|NCT01258738|147656142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9777|TWO_SIDED|95.0|-0.4|0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 4||0.39|-0.40|0.9777
73881518|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|4.45||0.9559|TWO_SIDED|95.0|-8.52|9.01||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||9.01|-8.52|0.9559
74052012|NCT01258738|147656142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.4453|TWO_SIDED|95.0|-0.28|0.65|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 8||0.65|-0.28|0.4453
74099504|NCT02755649|147748073|SUPERIORITY||Difference in Percentages|30.1|||=|0.0002|TWO_SIDED|95.0|14.63|45.64||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||45.64|14.63|= 0.0002
74099505|NCT02755649|147748073|SUPERIORITY||Difference in Percentages|31.6|||=|0.0001|TWO_SIDED|95.0|16.11|47.05||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||47.05|16.11|= 0.0001
74099506|NCT02755649|147748074|SUPERIORITY||LS Mean Difference|-7.6|||=|0.0003|TWO_SIDED|95.0|-11.64|-3.51||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.51|-11.64|= 0.0003
74099507|NCT02755649|147748074|SUPERIORITY||LS Mean Difference|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.15|-5.95||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.95|-14.15|< 0.0001
74099508|NCT02755649|147748075|SUPERIORITY||LS Mean Difference|-2.9|||=|0.0001|TWO_SIDED|95.0|-4.41|-1.43||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-1.43|-4.41|= 0.0001
74099509|NCT02755649|147748075|SUPERIORITY||LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.38|-2.4||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-2.4|-5.38|< 0.0001
74052013|NCT01258738|147656142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.5782|TWO_SIDED|95.0|-0.33|0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 12||0.60|-0.33|0.5782
74052014|NCT01258738|147656143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0414|TWO_SIDED|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-0.04|-1.88|0.0414
74052015|NCT01258738|147656144|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052016|NCT01258738|147656144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.93|||<|0.001|TWO_SIDED|95.0|-4.16|-1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-1.70|-4.16|<0.001
74099510|NCT02755649|147748076|SUPERIORITY||Difference in Percentages|29.5|||<|0.0001|TWO_SIDED|95.0|17.1|41.96||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||41.96|17.1|< 0.0001
74099511|NCT02755649|147748076|SUPERIORITY||Difference in Percentages|40.4|||<|0.0001|TWO_SIDED|95.0|28.24|52.61||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||52.61|28.24|< 0.0001
74099512|NCT02755649|147748077|SUPERIORITY||LS Mean Difference|-24.3|||<|0.0001|TWO_SIDED|95.0|-31.63|-16.88||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab group vs. placebo)of LS mean percent change using MI with ANCOVA with baseline measurement as covariate \& treatment,randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use\[Yes,No\])as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-16.88|-31.63|< 0.0001
74099513|NCT02755649|147748077|SUPERIORITY||LS Mean Difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-33.49|-18.86||Threshold for significance at 0.05 level.|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata (disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-18.86|-33.49|< 0.0001
74099514|NCT02755649|147748078|SUPERIORITY||LS Mean Difference|-9.7|||=|0.0017|TWO_SIDED|95.0|-15.8|-3.66||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens. CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.66|-15.8|= 0.0017
74099515|NCT02755649|147748078|SUPERIORITY||LS Mean Difference|-7.2|||=|0.0214|TWO_SIDED|95.0|-13.31|-1.06||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-1.06|-13.31|= 0.0214
74099516|NCT02755649|147748079|SUPERIORITY||Difference in Percentages|-4.7|||=|0.1486|TWO_SIDED|95.0|-10.97|1.58|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||1.58|-10.97|= 0.1486
74052017|NCT01258738|147656145|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052018|NCT01258738|147656145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0414|TWO_SIDED|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-0.04|-1.88|0.0414
74052019|NCT01258738|147656146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0132|TWO_SIDED|95.0|-0.72|-0.08|||ANCOVA|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."||-0.08|-0.72|0.0132
74052020|NCT01258738|147656147|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052021|NCT01258738|147656147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.2438|TWO_SIDED|95.0|-0.52|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.13|-0.52|0.2438
74052022|NCT01258738|147656147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.1958|TWO_SIDED|95.0|-0.42|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.09|-0.42|0.1958
74052023|NCT01258738|147656147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.1624|TWO_SIDED|95.0|-0.46|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.08|-0.46|0.1624
74099517|NCT02755649|147748079|SUPERIORITY||Difference in Percentages|-6.5|||=|0.0319|TWO_SIDED|95.0|-12.27|-0.65|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||-0.65|-12.27|= 0.0319
74052024|NCT01258738|147656147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0091|TWO_SIDED|95.0|-0.54|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.08|-0.54|0.0091
74052025|NCT01258738|147656148|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052026|NCT01258738|147656148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0836|TWO_SIDED|95.0|-1.32|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.08|-1.32|0.0836
74052027|NCT01258738|147656148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.5402|TWO_SIDED|95.0|-1.02|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.54|-1.02|0.5402
74052028|NCT01258738|147656148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.8167|TWO_SIDED|95.0|-0.69|0.87|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.87|-0.69|0.8167
74052029|NCT01258738|147656148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9891|TWO_SIDED|95.0|-0.72|0.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.73|-0.72|0.9891
74052030|NCT01258738|147656149|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052031|NCT01258738|147656149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6148|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.05|-0.08|0.6148
74099518|NCT02755649|147748080|SUPERIORITY||difference in percentages|0.0|||=|0.9829|TWO_SIDED|95.0|-3.6|3.53|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.53|-3.6|= 0.9829
74099519|NCT02755649|147748080|SUPERIORITY||difference in percentages|0.0|||=|1|TWO_SIDED|95.0|-3.6|3.63|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.63|-3.6|= 1
74099520|NCT02755649|147748081|SUPERIORITY||difference in percentages|0.9|||=|0.5619|TWO_SIDED|95.0|-2.19|3.97|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.97|-2.19|= 0.5619
74052032|NCT01258738|147656149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2547|TWO_SIDED|95.0|-0.11|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.03|-0.11|0.2547
74052033|NCT01258738|147656149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.1208|TWO_SIDED|95.0|-0.08|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.01|-0.08|0.1208
74052034|NCT01258738|147656149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.8291|TWO_SIDED|95.0|-0.13|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.17|-0.13|0.8291
74052035|NCT01258738|147656150|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
73881519|NCT03192176|147297634|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|4.49||0.2003|TWO_SIDED|95.0|-14.6|3.07||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||3.07|-14.60|0.2003
74052036|NCT01258738|147656150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.3536|TWO_SIDED|95.0|-0.64|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.23|-0.64|0.3536
74052037|NCT01258738|147656150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0769|TWO_SIDED|95.0|-0.97|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.05|-0.97|0.0769
74052038|NCT01258738|147656150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4698|TWO_SIDED|95.0|-0.7|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.33|-0.70|0.4698
74052039|NCT01258738|147656150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0167|TWO_SIDED|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.12|-1.19|0.0167
74052040|NCT01258738|147656151|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
74099521|NCT02755649|147748081|SUPERIORITY||difference in percentages|-0.9|||=|0.3241|TWO_SIDED|95.0|-2.73|0.88|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||0.88|-2.73|= 0.3241
74099522|NCT02755649|147748082|SUPERIORITY||difference in percentages|-0.4|||=|0.9518|TWO_SIDED|95.0|-12.6|11.9|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||11.9|-12.6|= 0.9518
74099523|NCT02755649|147748082|SUPERIORITY||difference in percentages|2.5|||=|0.6833|TWO_SIDED|95.0|-9.64|14.68|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||14.68|-9.64|= 0.6833
74052041|NCT01258738|147656151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|||<|0.0001|TWO_SIDED|95.0|-4.39|-1.66|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-1.66|-4.39|<0.0001
74052042|NCT01258738|147656151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.86||||0.0008|TWO_SIDED|95.0|-6.09|-1.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-1.62|-6.09|0.0008
74052043|NCT01258738|147656151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.04||||0.0143|TWO_SIDED|95.0|-5.47|-0.61|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.61|-5.47|0.0143
74099524|NCT02152605|147748083|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.03|||<|0.001|TWO_SIDED|95.0|-6.28|-1.79|||Mixed Models Analysis|||||-1.79|-6.28|<0.001
73888138|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|10.4||||0.001|TWO_SIDED|95.0|4.3|16.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|4.3|0.0010
74052044|NCT01258738|147656151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.0038|TWO_SIDED|95.0|-5.23|-1.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-1.02|-5.23|0.0038
74052045|NCT01258738|147656152|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test||||<0.001
74052046|NCT01258738|147656152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.71|||<|0.0001|TWO_SIDED|95.0|-10.85|-4.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-4.58|-10.85|<0.0001
74052047|NCT01258738|147656152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.12|||<|0.0001|TWO_SIDED|95.0|-9.16|-3.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-3.09|-9.16|<0.0001
74052048|NCT01258738|147656152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.78||||0.0009|TWO_SIDED|95.0|-9.15|-2.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-2.41|-9.15|0.0009
74099525|NCT02152605|147748084|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.122|||<|0.001|TWO_SIDED|95.0|0.071|0.172|||Mixed Models Analysis|||||0.172|0.071|<0.001
74099526|NCT02152605|147748085|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
74099527|NCT03301649|147748086|EQUIVALENCE|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|1.9|||||TWO_SIDED|90.0|-3.9|7.8||||||If the 90% confidence interval (CI) for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.||7.8|-3.9|
74099528|NCT03301649|147748087|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using last observation carried forward \[LOCF\] method).||||<0.0001
74099529|NCT03301649|147748087|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
74099530|NCT03301649|147748088|EQUIVALENCE|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|0.9|||||TWO_SIDED|90.0|-2.6|4.5||||||If the 90% CI for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.||4.5|-2.6|
74052049|NCT01258738|147656152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.03|||<|0.0001|TWO_SIDED|95.0|-10.34|-3.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-3.73|-10.34|<0.0001
73881520|NCT03192176|147297634|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|4.53||0.6692|TWO_SIDED|95.0|-10.86|6.98||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||6.98|-10.86|0.6692
74052050|NCT01258738|147656153|SUPERIORITY_OR_OTHER|||||||0.037|||||||t-test, 2 sided|||With the exception of change from Baseline in the placebo group at Week 12, within group comparisons to baseline for all other treatment groups and time points were \<0.001, from paired t-test.||||0.0370
74052051|NCT01258738|147656153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9965|TWO_SIDED|95.0|-4.39|4.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4||4.37|-4.39|0.9965
74052052|NCT01258738|147656153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.61||||0.197|TWO_SIDED|95.0|-1.89|9.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8||9.10|-1.89|0.1970
74052053|NCT01258738|147656153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.07||||0.0394|TWO_SIDED|95.0|0.3|11.84|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12||11.84|0.30|0.0394
74052054|NCT01258738|147656154|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.01 at Week 12 and \<0.001 thereafter, from paired t-test.||||<0.01
74052055|NCT01258738|147656154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.1341|TWO_SIDED|95.0|-0.02|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4||0.21|-0.02|0.1341
74052056|NCT01258738|147656154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.0447|TWO_SIDED|95.0|0.0|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8||0.14|0.00|0.0447
74052057|NCT01258738|147656154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.1345|TWO_SIDED|95.0|-0.02|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12||0.13|-0.02|0.1345
74052058|NCT01258738|147656155|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052059|NCT01258738|147656155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31||||0.1035|TWO_SIDED|95.0|-0.27|2.9|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||2.90|-0.27|0.1035
74052060|NCT01258738|147656155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38||||0.0134|TWO_SIDED|95.0|0.5|4.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||4.26|0.50|0.0134
74052061|NCT01258738|147656156|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.05, from paired t-test.||||<0.05
74052062|NCT01258738|147656156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18||||0.252|TWO_SIDED|95.0|-0.84|3.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||3.19|-0.84|0.2520
74052063|NCT01258738|147656156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.4981|TWO_SIDED|95.0|-1.63|3.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||3.34|-1.63|0.4981
74052064|NCT01258738|147656157|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052065|NCT01258738|147656157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.4621|TWO_SIDED|95.0|-0.9|0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.41|-0.90|0.4621
74052066|NCT01258738|147656157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.3842|TWO_SIDED|95.0|-1.28|0.5|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.50|-1.28|0.3842
74052067|NCT01258738|147656158|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052068|NCT01258738|147656158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.6357|TWO_SIDED|95.0|-0.52|0.86|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.86|-0.52|0.6357
74052069|NCT01258738|147656158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.2439|TWO_SIDED|95.0|-1.39|0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.36|-1.39|0.2439
74099531|NCT03301649|147748089|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
74052070|NCT01258738|147656159|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052071|NCT01258738|147656159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.3286|TWO_SIDED|95.0|-1.55|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||0.52|-1.55|0.3286
74052072|NCT01258738|147656160|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052073|NCT01258738|147656160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.1829|TWO_SIDED|95.0|-1.93|0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||0.37|-1.93|0.1829
74052074|NCT01258738|147656161|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.05, from paired t-test.||||<0.05
74052075|NCT01258738|147656161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37||||0.5226|TWO_SIDED|95.0|-4.95|9.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||9.68|-4.95|0.5226
74052076|NCT01258738|147656161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62||||0.6232|TWO_SIDED|95.0|-4.9|8.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||8.14|-4.90|0.6232
74052077|NCT01258738|147656161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.52||||0.3877|TWO_SIDED|95.0|-4.53|11.57|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||11.57|-4.53|0.3877
74052078|NCT01258738|147656161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.74||||0.2402|TWO_SIDED|95.0|-3.22|12.69|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||12.69|-3.22|0.2402
74052079|NCT01258738|147656162|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001 at Week 16 and thereafter, from paired t-test.||||<0.001
74052080|NCT01258738|147656162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.19||||0.0193|TWO_SIDED|95.0|-16.85|-1.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-1.52|-16.85|0.0193
74052081|NCT01258738|147656162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.08||||0.173|TWO_SIDED|95.0|-12.41|2.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||2.26|-12.41|0.1730
74052082|NCT01258738|147656162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.26||||0.1224|TWO_SIDED|95.0|-14.23|1.71|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||1.71|-14.23|0.1224
74052083|NCT01258738|147656162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.14||||0.0461|TWO_SIDED|95.0|-18.11|-0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.16|-18.11|0.0461
74052084|NCT01258738|147656163|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052085|NCT01258738|147656163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.97||||0.0372|TWO_SIDED|95.0|-11.58|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.36|-11.58|0.0372
74052086|NCT01258738|147656163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.2126|TWO_SIDED|95.0|-7.98|1.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||1.79|-7.98|0.2126
74052087|NCT01258738|147656163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.66||||0.033|TWO_SIDED|95.0|-12.79|-0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.54|-12.79|0.0330
74052088|NCT01258738|147656163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.85||||0.0397|TWO_SIDED|95.0|-13.38|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.33|-13.38|0.0397
74052089|NCT01258738|147656164|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001 at Week 16 and at Week 32 and thereafter, from paired t test.||||<0.001
74052090|NCT01258738|147656164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.29||||0.0382|TWO_SIDED|95.0|-16.12|-0.46|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.46|-16.12|0.0382
74052091|NCT01258738|147656164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.25||||0.1648|TWO_SIDED|95.0|-12.69|2.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||2.19|-12.69|0.1648
74052092|NCT01258738|147656164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98||||0.1476|TWO_SIDED|95.0|-14.11|2.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||2.15|-14.11|0.1476
74099532|NCT03301649|147748089|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
74099533|NCT01564537|147748090|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.742||||0.012|TWO_SIDED|95.0|0.587|0.939|||Log Rank||HR is estimated from Cox Regression.|||0.939|0.587|0.012
74099534|NCT01564537|147748091|SUPERIORITY||Hazard Ratio (HR)|0.939|||=|0.495|TWO_SIDED|95.0|0.784|1.125|||Log Rank||HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.|||1.125|0.784|=0.495
74052093|NCT01258738|147656164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.68||||0.0687|TWO_SIDED|95.0|-18.03|0.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.68|-18.03|0.0687
74052094|NCT01258738|147656165|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052095|NCT01258738|147656165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.2578|TWO_SIDED|95.0|-1.21|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.33|-1.21|0.2578
74052096|NCT01258738|147656165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.4334|TWO_SIDED|95.0|-1.21|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.52|-1.21|0.4334
74052097|NCT01258738|147656166|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
74052098|NCT01258738|147656166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.3554|TWO_SIDED|95.0|-4.7|1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||1.70|-4.70|0.3554
74052099|NCT01258738|147656166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91||||0.335|TWO_SIDED|95.0|-5.82|1.99|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||1.99|-5.82|0.3350
74052100|NCT01258738|147656167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41||||14.41|TWO_SIDED|95.0|0.04|28.78|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||28.78|0.04|14.41
74052101|NCT01258738|147656168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.03||||0.1285|TWO_SIDED|95.0|-2.51|24.56|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||24.56|-2.51|0.1285
74052102|NCT00568399|147656171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|STANDARD_DEVIATION|0.987||0.001|TWO_SIDED|95.0||||Coronary calcium score after treatment compared to baseline|Wilcoxon (Mann-Whitney)|||This was a pilot study without a control group. There were no power calculations (see manuscript).||||0.001
74052103|NCT00783263|147656196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.25|||<|0.001|TWO_SIDED|95.0|-19.89|-10.6|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time, stratum and the interaction of time by treatment.||||-10.60|-19.89|<0.001
74052104|NCT00783263|147656197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.31|||<|0.001|TWO_SIDED|95.0|-18.95|-5.67|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.||||-5.67|-18.95|<0.001
74052105|NCT00783263|147656197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.46|||<|0.001|TWO_SIDED|95.0|-23.92|-10.99|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.||||-10.99|-23.92|<0.001
74052106|NCT00783263|147656198|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5|||<|0.001|TWO_SIDED|95.0|2.9|6.9|||Logistic Regression|Logistic Regression included terms for treatment, stratum and baseline LDL-C category (3 levels: \<100, 100-\<130, ≥130 mg/dL).||||6.9|2.9|<0.001
74052107|NCT00783263|147656199|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.1|||<|0.001|TWO_SIDED|95.0|1.7|5.8|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: \<100, 100-\<130, \>=130 mg/dL).||||5.8|1.7|<0.001
74052108|NCT00783263|147656199|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|3.4|12.3|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: \<100, 100-\<130, \>=130 mg/dL).||||12.3|3.4|<0.001
74052109|NCT00783263|147656200|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.0|||<|0.001|TWO_SIDED|95.0|4.6|14.0|||Logistic Regression|||||14.0|4.6|<0.001
74052110|NCT00783263|147656201|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|2.2|11.8|||Logistic Regression|||Stratum I||11.8|2.2|<0.001
74052111|NCT00783263|147656201|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.4|||<|0.001|TWO_SIDED|95.0|5.2|24.8|||Logistic Regression|||Stratum II||24.8|5.2|<0.001
74052112|NCT00783263|147656202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.65|||<|0.001|TWO_SIDED|95.0|-11.59|-5.71|||Longitudinal Data Analysis|||Total Cholesterol (mg/dL)||-5.71|-11.59|<0.001
74099535|NCT01564537|147748092|SUPERIORITY||Hazard Ratio (HR)|0.916|||=|0.764|TWO_SIDED|95.0|0.516|1.626|||Log Rank||HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.|||1.626|0.516|=0.764
74052113|NCT00783263|147656202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.306|TWO_SIDED|95.0|-9.04|2.84|||Longitudinal Data Analysis|||Triglycerides (mg/dL)||2.84|-9.04|0.306
74052114|NCT00783263|147656202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.15||||0.111|TWO_SIDED|95.0|-4.79|0.49|||Longitudinal Data Analysis|||High-Density Lipoprotein Cholesterol||0.49|-4.79|0.111
74052115|NCT00783263|147656202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.98|||<|0.001|TWO_SIDED|95.0|-16.1|-7.86|||Longitudinal Data Analysis|||Non High-Density Liproprotein Cholesterol||-7.86|-16.10|<0.001
74052116|NCT00783263|147656202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.25|||<|0.001|TWO_SIDED|95.0|-18.36|-8.13|||Longitudinal Data Analysis|||LDL Cholesterol/HDL Cholesterol||-8.13|-18.36|<0.001
74052117|NCT00783263|147656202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.45||||0.002|TWO_SIDED|95.0|-10.53|-2.36|||Longitudinal Data Analysis|||Total Cholesterol/HDL Cholesterol||-2.36|-10.53|0.002
74052118|NCT00783263|147656202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.52||||0.001|TWO_SIDED|95.0|-15.3|-3.75|||Longitudinal Data Analysis|||Non-HDL Cholestrol/HDL Cholesterol||-3.75|-15.30|0.001
74052119|NCT00783263|147656202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.41|||<|0.001|TWO_SIDED|95.0|-12.74|-6.08|||Longitudinal Data Analysis|||Apolipoprotein B (Apo B)||-6.08|-12.74|<0.001
74052120|NCT00783263|147656202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.82||||0.102|TWO_SIDED|95.0|-3.99|0.36|||Longitudinal Data Analysis|||Apolipoprotein A-I (Apo A-I)||0.36|-3.99|0.102
74052121|NCT00783263|147656202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.54|||<|0.001|TWO_SIDED|95.0|-11.25|-3.83|||Longitudinal Data Analysis|||Apolipoprotein B/Apo A-I||-3.83|-11.25|<0.001
74052122|NCT00783263|147656202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.08||||0.861|TWO_SIDED|95.0|-13.13|10.97|||Longitudinal Data Analysis|||hs-C-Reactive Protein||10.97|-13.13|0.861
74052123|NCT00405756|147656213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.395|||<|0.001|TWO_SIDED|95.0|0.278|0.56||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.560|0.278|<0.001
74052124|NCT00405756|147656213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.494|||<|0.001|TWO_SIDED|95.0|0.347|0.702||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.702|0.347|<0.001
74052125|NCT00405756|147656213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.134|TWO_SIDED|95.0|0.589|1.075||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||1.075|0.589|0.134
74052126|NCT00405756|147656214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.214|0.541|||Log Rank|P-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.||||0.541|0.214|<0.001
74052127|NCT00405756|147656216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.337|||<|0.001|TWO_SIDED|95.0|0.231|0.493||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.493|0.231|<0.001
74052128|NCT00405756|147656216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.414|||<|0.001|TWO_SIDED|95.0|0.284|0.603||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.603|0.284|<0.001
74052129|NCT00405756|147656216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.826||||0.223|TWO_SIDED|95.0|0.606|1.125||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||1.125|0.606|0.223
74052130|NCT00405756|147656217|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||<0.001
74052131|NCT00405756|147656217|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||0.009
74052132|NCT00405756|147656217|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||0.003
74052133|NCT00405756|147656217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.04|5.47|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||5.47|2.04|<0.001
74052134|NCT00405756|147656217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.096|TWO_SIDED|95.0|0.95|2.62|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||2.62|0.95|0.096
74052135|NCT00405756|147656217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.12||||0.002|TWO_SIDED|95.0|1.33|3.37|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||3.37|1.33|0.002
74099536|NCT01564537|147748104|SUPERIORITY||Odds Ratio (OR)|1.3|||=|0.332|TWO_SIDED|95.0|0.69|2.45||P-value is from Cochran-Mantel-Haenszel stratified by: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve), and ISS Stage at Screening (I or II, III).|Cochran-Mantel-Haenszel||Odds ratio is from logistic regression model with prognostic factors: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve),and ISS Stage at Screening (I or II, III). Odds ratio \> 1 favors Ixazomib.|||2.45|0.69|=0.332
74052136|NCT00405756|147656219|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.348|||<|0.001|TWO_SIDED|95.0|0.228|0.531||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.531|0.228|<0.001
74052137|NCT00405756|147656219|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.419|||<|0.001|TWO_SIDED|95.0|0.281|0.623||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.623|0.281|<0.001
74052138|NCT00405756|147656219|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.302|TWO_SIDED|95.0|0.571|1.191||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||1.191|0.571|0.302
74052139|NCT00405756|147656220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.404|||<|0.001|TWO_SIDED|95.0|0.296|0.553||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.553|0.296|<0.001
74099537|NCT01635218|147748115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.05|TWO_SIDED|95.0|3.1|7.0||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||7.0|3.1|<0.05
74099538|NCT01635218|147748115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|0.81|<|0.05|TWO_SIDED|95.0|1.31|5.25||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||5.25|1.31|<0.05
74052140|NCT00405756|147656220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.499|||<|0.001|TWO_SIDED|95.0|0.363|0.688||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.688|0.363|<0.001
74052141|NCT00405756|147656220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.827||||0.169|TWO_SIDED|95.0|0.63|1.085||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||1.085|0.630|0.169
74052142|NCT00147082|147656242|SUPERIORITY|||||||0.05||||||The threshold for significance was p\<0.05|Kruskal-Wallis|||p values were calculated||||0.05
74052143|NCT00147082|147656243|SUPERIORITY|||||||0.05||||||The p value (\<0.05) was the threshold for significance|Kruskal-Wallis|||p value was calculated||||0.05
74052144|NCT00147082|147656244|SUPERIORITY|||||||0.05||||||The p value (\<0.05) was the threshold for significance|Kruskal-Wallis|||The p value was calculated||||0.05
74052145|NCT02996981|147656245|SUPERIORITY|||||||0.299|||||||Chi-squared|df=1||||||0.299
74052146|NCT01117428|147656247|EQUIVALENCE|Differences between Parts E and F in terms of Best Overall Response evaluated from screening until disease progression.||||||0.6645||||||No adjustment, 5% significance level|Fisher Exact|||||||0.6645
74052147|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.4|<0.0001
74052148|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.7|<0.0001
74099539|NCT01635218|147748116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|1.71||0.14|TWO_SIDED|95.0|-0.73|7.61||The statistical significant ANOVA result (p\<0.05) suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||7.61|-0.73|0.14
74052149|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.4||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.4|-2.0|<0.0001
73881521|NCT03192176|147297634|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|4.51||0.6894|TWO_SIDED|95.0|-10.68|7.08||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||7.08|-10.68|0.6894
74052150|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|0.3||||0.0799|TWO_SIDED|95.0|0.0|0.6||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.6|-0.0|0.0799
74052151|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.1||||0.3942|TWO_SIDED|95.0|-0.4|0.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.2|-0.4|0.3942
74052152|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.3||||0.0272|TWO_SIDED|95.0|-0.6|0.0||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurement||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.0|-0.6|0.0272
74052153|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.5|-1.1|<0.0001
74099540|NCT01635218|147748116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|1.73||0.99|TWO_SIDED|95.0|-2.93|5.5||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||5.5|-2.93|0.99
74099541|NCT01635218|147748117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.11|||<|0.05|TWO_SIDED|95.0|0.03|0.34|||Chi-squared|||||0.34|0.03|<0.05
74099542|NCT01635218|147748117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.05|TWO_SIDED|95.0|0.06|0.56|||Chi-squared|||||0.56|0.06|<0.05
74099543|NCT01635218|147748118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|2.42||0.002|TWO_SIDED|95.0|2.72|14.52||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||14.52|2.72|0.002
74099544|NCT01635218|147748118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|STANDARD_ERROR_OF_MEAN|2.37||0.424|TWO_SIDED|95.0|-2.33|9.6||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||9.6|-2.33|0.424
74099545|NCT01635218|147748119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||0.1||95.0|0.05|1.32|||Chi-squared|||||1.32|0.05|0.10
74099546|NCT01635218|147748119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.11|TWO_SIDED|95.0|0.05|1.39|||Chi-squared|||||1.39|0.05|0.11
74099547|NCT03262038|147748132|SUPERIORITY|||||||0.412|||||||Chi-squared|||||||.412
74099548|NCT03262038|147748133|SUPERIORITY|||||||0.633|||||||Chi-squared|||||||.633
74099549|NCT03262038|147748134|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||.007
74099550|NCT03262038|147748135|SUPERIORITY|||||||0.634|||||||Chi-squared|||||||.634
74099551|NCT00094861|147748158|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.8553||||0.355||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 2 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.3550
74099552|NCT00094861|147748159|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.9936||||0.3189||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.3189
74099553|NCT00094861|147748160|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.437||||0.5086||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade 5 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.5086
74099554|NCT00094861|147748161|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.46||||0.4976||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 3 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.4976
74099555|NCT00094861|147748162|SUPERIORITY_OR_OTHER||Chi-Square Statistic|-2.5325||||0.1115||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants who never received radiotherapy were assumed to have unplanned breaks.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.1115
74099556|NCT00094861|147748163|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.4812||||0.0621|TWO_SIDED|||||Generalized Cochran-Mantel-Haenszel (CMH) test for mean score difference using modified ridit score. Participants without any ECOG assessment post baseline were assumed to have ECOG status of 5 in the CMH test.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.0621
74099557|NCT00094861|147748164|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.0294||||0.8639||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.8639
74099558|NCT00094861|147748165|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.1414||||0.1996||||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.1996
74099559|NCT02549027|147748170|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.24|||||TWO_SIDED|90.0|0.12|0.47|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% confidence interval (CI) were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.47|0.12|
74099560|NCT02549027|147748170|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.21|||||TWO_SIDED|90.0|0.1|0.41|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.41|0.10|
74099561|NCT02549027|147748170|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.15|||||TWO_SIDED|90.0|0.08|0.3|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.30|0.08|
74099562|NCT02549027|147748171|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.05|||||TWO_SIDED|90.0|0.02|0.11|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio.||0.11|0.02|
74099563|NCT02549027|147748174|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.67|1.07|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||1.07|0.67|
74099564|NCT02549027|147748174|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.68|||||TWO_SIDED|90.0|0.54|0.86|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||0.86|0.54|
74099565|NCT02549027|147748174|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.75|||||TWO_SIDED|90.0|0.6|0.95|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||0.95|0.60|
74099566|NCT02549027|147748175|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.63|||||TWO_SIDED|90.0|0.5|0.79|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio.||0.79|0.50|
74099567|NCT02549027|147748176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||||TWO_SIDED|90.0|-12.01|17.2|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||17.20|-12.01|
74052154|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.5|<0.0001
74052155|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.1|-1.7|<0.0001
74052156|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|0.2||||0.1958|TWO_SIDED|95.0|-0.1|0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.5|-0.1|0.1958
74052157|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.2||||0.1868|TWO_SIDED|95.0|-0.5|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.1|-0.5|0.1868
74052158|NCT03018028|147656257|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4||||0.0077|TWO_SIDED|95.0|-0.7|-0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.7|0.0077
74052159|NCT03018028|147656284|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.2579|TWO_SIDED|95.0|0.29|1.4||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.40|0.29|0.2579
74052160|NCT03018028|147656284|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.25||||0.0052|TWO_SIDED|95.0|0.1|0.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.66|0.10|0.0052
73881522|NCT03192176|147297634|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|4.35||0.1627|TWO_SIDED|95.0|-14.66|2.48||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||2.48|-14.66|0.1627
74052161|NCT03018028|147656284|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31||||0.0259|TWO_SIDED|95.0|0.11|0.87||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.87|0.11|0.0259
74052162|NCT03018028|147656284|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.7||||0.0674|TWO_SIDED|95.0|0.93|7.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||7.80|0.93|0.0674
74052163|NCT03018028|147656284|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.07||||0.9087|TWO_SIDED|95.0|0.32|3.54||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||3.54|0.32|0.9087
73881523|NCT03192176|147297634|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.48||0.9371|TWO_SIDED|95.0|-9.18|8.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||8.47|-9.18|0.9371
74052164|NCT03018028|147656284|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33||||0.6498|TWO_SIDED|95.0|0.38|4.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||4.62|0.38|0.6498
74052165|NCT03018028|147656285|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.34||||0.0219|TWO_SIDED|95.0|0.14|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.86|0.14|0.0219
74052166|NCT03018028|147656285|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15||||0.0005|TWO_SIDED|95.0|0.05|0.44||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.44|0.05|0.0005
74052167|NCT03018028|147656285|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.23||||0.0098|TWO_SIDED|95.0|0.07|0.7||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.70|0.07|0.0098
74052168|NCT03018028|147656285|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.95||||0.1193|TWO_SIDED|95.0|0.76|11.46||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||11.46|0.76|0.1193
74052169|NCT03018028|147656285|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.31||||0.7147|TWO_SIDED|95.0|0.31|5.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||5.56|0.31|0.7147
74099568|NCT02549027|147748176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.28|||||TWO_SIDED|90.0|-9.33|19.88|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||19.88|-9.33|
74099569|NCT02549027|147748176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.38|||||TWO_SIDED|90.0|-8.23|20.98|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||20.98|-8.23|
73881524|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.8|STANDARD_ERROR_OF_MEAN|4.53||0.8521|TWO_SIDED|95.0|-8.07|9.77||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.77|-8.07|0.8521
73881525|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|4.56||0.9367|TWO_SIDED|95.0|-8.62|9.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.35|-8.62|0.9367
74052170|NCT03018028|147656285|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.97||||0.3765|TWO_SIDED|95.0|0.44|8.85||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||8.85|0.44|0.3765
74052171|NCT02532998|147656307|SUPERIORITY_OR_OTHER||Treatment differences|-1.258|||||TWO_SIDED|90.0|-1.721|0.7945|||mixed linear model|Analyses done using mixed linear model involving fixed effect, random effect, and a covariate.||Statistical analysis of urinary sodium/potassium ratio between Treatment C and Treatment D.||0.7945|-1.721|
74052172|NCT02532998|147656322|SUPERIORITY_OR_OTHER||Treatment differences|3.409|||||TWO_SIDED|90.0|2.946|3.872|||mixed linear model|Analyses done using mixed linear model involving fixed effect, random effect, and a covariate.||Statistical analysis of urinary sodium/potassium ratio between Treatment A and Treatment B.||3.872|2.946|
74052173|NCT02519777|147656334|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.60
74052174|NCT02519777|147656334|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.33
74052175|NCT02519777|147656334|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.61
74099570|NCT02549027|147748177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3|||||TWO_SIDED|90.0|-7.1|25.7|||||Difference is MK-6096 - placebo|Mean treatment difference in change from baseline of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed.||25.70|-7.10|
74099571|NCT03578549|147748189|OTHER||Correlation Coefficient|0.01||||0.92|TWO_SIDED||||||ANOVA|||||||0.92
74099572|NCT02318303|147748202|SUPERIORITY||Mean Difference (Final Values)|-1.1087|||<|0.0001|TWO_SIDED|97.5|-1.669|-0.5485|||ANCOVA|||||-0.5485|-1.6690|<0.0001
74099573|NCT02318303|147748202|SUPERIORITY||Mean Difference (Final Values)|-1.1703|||<|0.0001|TWO_SIDED|97.5|-1.7315|-0.609|||ANCOVA|||||-0.6090|-1.7315|<0.0001
73881526|NCT03192176|147297634|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|4.57||0.0551|TWO_SIDED|95.0|-17.82|0.19||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||0.19|-17.82|0.0551
74052176|NCT02519777|147656336|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.61
74052177|NCT02519777|147656336|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.72
74052178|NCT02519777|147656336|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.79
74052179|NCT02519777|147656336|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.55
74099574|NCT02318303|147748202|SUPERIORITY||Mean Difference (Final Values)|-0.7718||||0.002|TWO_SIDED|95.0|-1.2616|-0.282|||ANCOVA|||||-0.2820|-1.2616|0.0020
74099575|NCT02318303|147748202|SUPERIORITY||Mean Difference (Final Values)|-0.3563||||0.1524|TWO_SIDED|95.0|-0.8445|0.1319|||ANCOVA|||||0.1319|-0.8445|0.1524
74099576|NCT02318303|147748202|SUPERIORITY||Mean Difference (Final Values)|-0.4918||||0.0488|TWO_SIDED|95.0|-0.981|-0.0025|||ANCOVA|||||-0.0025|-0.9810|0.0488
74099577|NCT02318303|147748202|SUPERIORITY||Mean Difference (Final Values)|-0.7133||||0.0043|TWO_SIDED|95.0|-1.2031|-0.2235|||ANCOVA|||||-0.2235|-1.2031|0.0043
74099578|NCT02368314|147748203|SUPERIORITY_OR_OTHER|||||||0.226|||||||Fisher Exact|||||||0.226
74099579|NCT01120704|147748310|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.906||||0.045|TWO_SIDED|95.0|0.822|0.998|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||.998|.822|.045
74099580|NCT01120704|147748310|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.982||||0.705|TWO_SIDED|95.0|0.892|1.081|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.081|.892|.705
74099581|NCT01120704|147748310|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.044||||0.382|TWO_SIDED|95.0|0.948|1.149|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.149|.948|.382
74099582|NCT01120704|147748310|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.954||||0.339|TWO_SIDED|95.0|0.867|1.05|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.050|.867|.339
74052180|NCT02519777|147656336|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.47
74052181|NCT02519777|147656336|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.95
74052182|NCT02519777|147656336|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.85
74052183|NCT02519777|147656336|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.67
74052184|NCT02519777|147656336|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.70
74052185|NCT02519777|147656337|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 24 from baseline||||0.99
74052186|NCT02519777|147656337|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 48 from baseline||||0.97
74052187|NCT02519777|147656337|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 72 from baseline||||0.79
74052188|NCT02519777|147656337|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 96 from baseline||||0.99
74052189|NCT02519777|147656337|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline||||0.74
74052190|NCT02519777|147656337|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline||||0.69
74052191|NCT02519777|147656337|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline||||0.44
74099583|NCT01120704|147748310|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.945||||0.248|TWO_SIDED|95.0|0.858|1.04|||Regression, Cox|||||1.040|.858|.248
74052192|NCT02519777|147656337|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline||||1.00
74052193|NCT02519777|147656337|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline||||0.83
74052194|NCT02519777|147656337|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline||||0.80
74052195|NCT02519777|147656337|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline||||0.86
74052196|NCT02519777|147656337|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline||||1.00
74052197|NCT02519777|147656338|SUPERIORITY||Difference in Percentage of Participants|3.32|||||TWO_SIDED|95.0|-2.78|9.42||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||9.42|-2.78|
74052198|NCT02519777|147656338|SUPERIORITY||Difference in Percentage of Participants|5.17|||||TWO_SIDED|95.0|-0.53|10.87||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||10.87|-0.53|
74052199|NCT02519777|147656338|SUPERIORITY||Difference in Percentage of Participants|-8.21|||||TWO_SIDED|95.0|-16.56|0.13||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||0.13|-16.56|
74052200|NCT02519777|147656338|SUPERIORITY||Difference in Percentage of Participants|3.17|||||TWO_SIDED|95.0|-3.07|9.42||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||9.42|-3.07|
74052201|NCT02519777|147656338|SUPERIORITY||Difference in Percentage of Participants|3.48|||||TWO_SIDED|95.0|-3.11|10.06||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||10.06|-3.11|
74052202|NCT02519777|147656338|SUPERIORITY||Difference in Percentage of Participants|-1.85|||||TWO_SIDED|95.0|-7.89|4.19||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||4.19|-7.89|
74099584|NCT01120704|147748311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.402||||0.011|TWO_SIDED|95.0|1.08|1.821|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., 8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum) would result in significantly higher abstinence at 52 weeks after target quit day.||1.821|1.080|.011
74099585|NCT01120704|147748311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.008||||0.956|TWO_SIDED|95.0|0.769|1.321|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Maintenance Counseling vs. Maintenance Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.||1.321|.769|.956
74099586|NCT01120704|147748311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.018||||0.885|TWO_SIDED|95.0|0.797|1.301|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.||1.301|.797|.885
74052203|NCT02519777|147656338|SUPERIORITY||Difference in Percentage of Participants|-0.15|||||TWO_SIDED|95.0|-4.53|4.23||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||4.23|-4.53|
74052204|NCT02519777|147656338|SUPERIORITY||Difference in Percentage of Participants|-1.69|||||TWO_SIDED|95.0|-4.99|1.6||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||1.60|-4.99|
74052205|NCT02519777|147656338|SUPERIORITY||Difference in Percentage of Participants|6.36|||||TWO_SIDED|95.0|-2.7|15.42||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||15.42|-2.70|
74052206|NCT02519777|147656340|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 24 from baseline||||0.67
74052207|NCT02519777|147656340|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 48 from baseline||||0.78
74052208|NCT02519777|147656340|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 96 from baseline||||0.94
74052209|NCT02519777|147656340|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline||||0.42
74052210|NCT02519777|147656340|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline||||0.07
74052211|NCT02519777|147656340|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline||||0.37
74052212|NCT02519777|147656340|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline||||0.08
74052213|NCT02519777|147656340|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline||||0.33
74052214|NCT02519777|147656340|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline||||0.56
74052215|NCT02519777|147656342|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 24 from baseline||||0.63
74052216|NCT02519777|147656342|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 48 from baseline||||0.38
74052217|NCT02519777|147656342|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 96 from baseline||||0.95
74052218|NCT02519777|147656342|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline||||0.27
74052219|NCT02519777|147656342|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline||||0.23
74099587|NCT01120704|147748311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.852||||0.205|TWO_SIDED|95.0|0.664|1.092|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback) would result in significantly higher abstinence at 52 weeks after target quit day.||1.092|.664|.205
73881527|NCT03192176|147297634|SUPERIORITY||LSMean differencce|-3.2|STANDARD_ERROR_OF_MEAN|4.64||0.4936|TWO_SIDED|95.0|-12.32|5.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||5.96|-12.32|0.4936
74052220|NCT02519777|147656342|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline||||0.09
74052221|NCT02519777|147656342|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline||||0.03
74052222|NCT02519777|147656342|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline||||0.02
74052223|NCT02519777|147656342|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline||||0.09
74052224|NCT02519777|147656343|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 sCD14 in plasma at Week 48 from baseline||||1.00
74052225|NCT02519777|147656343|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline||||0.95
74052226|NCT02519777|147656343|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline||||0.96
74052227|NCT02519777|147656344|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||0.52
74052228|NCT02519777|147656344|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||<0.01
74052229|NCT02519777|147656344|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||<0.01
74052230|NCT02519777|147656345|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.91
74052231|NCT02519777|147656345|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.86
74052232|NCT02519777|147656345|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.94
74052233|NCT02519777|147656346|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 VCAM in plasma at Week 48 from baseline||||0.70
74052234|NCT02519777|147656346|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline||||0.28
74052235|NCT02519777|147656346|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline||||0.85
74052236|NCT02519777|147656347|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.99
73888139|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|5.7||||0.0667|TWO_SIDED|95.0|-0.4|11.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.8|-0.4|0.0667
74052237|NCT02519777|147656347|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.26
74052238|NCT02519777|147656347|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.20
74052239|NCT02519777|147656348|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.59
74052240|NCT02519777|147656348|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.39
74052241|NCT02519777|147656348|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.80
74052242|NCT02519777|147656349|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.90
74052243|NCT02519777|147656349|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.14
74052244|NCT02519777|147656349|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.49
74052245|NCT02519777|147656350|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 NFL in CSF at Week 48 from baseline||||0.52
74052246|NCT02519777|147656350|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline||||0.99
74052247|NCT02519777|147656350|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline||||0.54
74052248|NCT00203294|147656410|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Separate models were fit to the change scores for headache pain, nausea and vomiting, photophobia, phonophobia, and neck pain.|Fisher Exact|||Fisher's exact test was used to compare nominal variables between groups. The Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.||||<0.01
74052249|NCT00203294|147656410|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Fisher Exact|Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.||Fisher's exact test was used to compare nominal variables between groups.||||<0.01
74099588|NCT01120704|147748311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.514|TWO_SIDED|95.0|0.842|1.411|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls) would result in significantly higher abstinence at 52 weeks after target quit day.||1.411|.842|.514
74099589|NCT05162014|147748312|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|Cox proportional hazards regression models based on time-to-first acute pancreatitis used to estimate the hazard ratios.||||1.02|0.76|
74099590|NCT03485365|147748321|OTHER|Bayesian Repeated Measures Model|Median Difference (Net)|-1.18|STANDARD_DEVIATION|0.494|||TWO_SIDED|95.0|-2.15|-0.2|||||Posterior median difference (GSK3858279 - Placebo) and 95% credible interval is presented.|||-0.20|-2.15|
74099591|NCT03485365|147748322|OTHER|Bayesian Repeated Measures Model|Median Difference (Net)|-1.09|STANDARD_DEVIATION|0.612|||TWO_SIDED|95.0|-2.29|0.12|||||Posterior median difference (GSK3858279 - Placebo) and 95% credible interval is presented.|||0.12|-2.29|
74099592|NCT03332979|147748356|OTHER|Multivariable regression analysis will be used to enable us to explore the impact of modifiable factors reflecting preparation for end of life on the MMCGI-SF.|||||<|0.05|||||||Regression, Linear||||Multivariable regression will be used to explore preparation for end of life on the MMCGI-SF. The analyses will use the MMCGI-SF as the dependent variable with five predictor variables (dementia knowledge \[DKAS\], Social support \[HLQ1\], Communication with healthcare professionals \[HLW4\], advance decisions and knowledge of end of life wishes of person with dementia. There will also be 10 confounders included in the model (gender of caregiver, living arrangement of person with dementia \[at home of a care home\], aged of person with dementia, dementia severity \[CDR\], change in closeness, religiosity \[DURAL\], deprivation and relationship of the carer to the person with dementia).|||<0.05
74052250|NCT00082628|147656414|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Nonparametric ANCOVA Model|||||||<0.001
74052251|NCT01566981|147656419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6925|STANDARD_DEVIATION|1.4708||0.005|TWO_SIDED|95.0|0.2221|1.1629|||t-test, 2 sided|without adjustments, df=39||"Null hypothesis was that Information and Communication Technology (ICT) supported diabetes care could have significant impact on reduction of baseline glycated hemoglobin (EHbA1c) after 1 year follow-up.~The sample in intervention group was normally distributed, so observed power (two-tailed hypothesis) was 0.45, for Cohen's d= 0.6 and alpha level =0.05"||1.1629|0.2221|0.005
74052252|NCT03062605|147656429|OTHER|Inequality test||||||0.35||||||Significant at p \< 0.05|McNemar|||Strep Mutans, Baseline-12 Weeks||||0.35
74052253|NCT03062605|147656429|OTHER|Inequality test||||||0.29||||||Significant at p\<0.05|McNemar|||Strep Mutans, Baseline-12 Weeks||||0.29
74052254|NCT03062605|147656429|OTHER|Inequality test||||||0.09||||||Significant at p \< 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks||||0.09
74099593|NCT05147324|147748364|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
74052255|NCT03062605|147656429|OTHER|Inequality test||||||0.13||||||Significant at p \< 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks||||0.13
74052256|NCT01234337|147656430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973|||=|0.405618|TWO_SIDED|95.0|0.779|1.217||One-sided p-value from log rank test (stratified per randomization as in interactive voice response system \[IVRS\]).|Log Rank|||PFS was compared using a stratified log-rank test with a one-sided alpha of 0.005, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95 percent (%) CIs were calculated using the Cox model, stratified by the above factors. A Hazard ratio of less than (\<) 1 indicates superiority of Sorafenib + Capecitabine over Placebo + Capecitabine.||1.217|0.779|=0.405618
74099594|NCT05147324|147748365|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
74099595|NCT05147324|147748373|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
74099596|NCT01175031|147748396|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||signed-rank tests|||||||0.003
74099597|NCT00555360|147748400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|2.0||0.975|TWO_SIDED|95.0|-4.62|4.77|||Regression, Logistic|||||4.77|-4.62|.975
74099598|NCT00555360|147748401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87|STANDARD_DEVIATION|1.7||0.349|TWO_SIDED|95.0|-5.78|2.05|||Regression, Logistic|||||2.05|-5.78|.349
74099599|NCT00555360|147748402|SUPERIORITY_OR_OTHER||Difference in Percent|14.0|STANDARD_DEVIATION|6.0||0.007|TWO_SIDED|95.0|3.9|24.2|||Regression, Logistic|||||24.2|3.9|.007
74052257|NCT01234337|147656431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.195|||=|0.930088|TWO_SIDED|95.0|0.943|1.513||One-sided p-value from log rank test (stratified per randomization as in IVRS). OS was compared using a stratified log-rank test, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease.|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by randomization factors.|At the time of PFS final analysis, it was OS interim analysis (IA) with 285 total death events. According to protocol specified O'Brien-Fleming type alpha spending function and 285 death events at IA, the prespecified alpha for this analysis was 0.0075 (one-sided). A Hazard ratio \< 1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.||1.513|0.943|=0.930088
74052258|NCT01234337|147656432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||=|0.2105|TWO_SIDED|95.0|0.723|1.146||One-sided p-value from log rank test (stratified per randomization as in IVRS).|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by the above factors.|TTP was compared using a stratified log-rank test with a one-sided alpha of 0.025, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. A Hazard ratio \<1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.||1.146|0.723|=0.2105
74052259|NCT01234337|147656433|SUPERIORITY_OR_OTHER||Percent Difference|1.93|||=|0.257412|TWO_SIDED|95.0|-3.9|7.77||One-sided p-value from Cochran Mantel-Haenszel test (stratified per randomization as in IVRS)|Cochran-Mantel-Haenszel|||ORR and 95% CI based on Cochran Mantel-Haenszel Test stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. Difference = (Placebo + Capecitabine) - (Sorafenib + Capecitabine).||7.77|-3.9|=0.257412
74052260|NCT01234337|147656434|SUPERIORITY_OR_OTHER||Percent Difference|-2.34|||=|0.284674|TWO_SIDED|95.0|-10.4|5.72||One-sided p-value from Cochran-Mantel-Haenszel test (stratified per randomization as in IVRS).|Cochran-Mantel-Haenszel|||"DCR and 95% CI based on general association Cochran-Mantel-Haenszel statistic with one-sided alpha of 0.025 stratified by number of prior chemotherapies for metastatic disease, hormone receptor status, and region. Difference = Placebo + Capecitabine - Sorafenib + Capecitabine."||5.72|-10.4|=0.284674
74052261|NCT01234337|147656436|SUPERIORITY_OR_OTHER||LSM Difference|-0.441|||||TWO_SIDED|95.0|-0.967|0.086||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.086|-0.967|
74052262|NCT01234337|147656437|SUPERIORITY_OR_OTHER||LSM Difference|-0.025|||||TWO_SIDED|95.0|-0.053|0.002||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.002|-0.053|
74052263|NCT01234337|147656438|SUPERIORITY_OR_OTHER||LSM Difference|-1.696|||||TWO_SIDED|95.0|-3.619|0.227||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.227|-3.619|
74052264|NCT01234337|147656439|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.14|||||TWO_SIDED|90.0|0.92|1.4||||||Statistical analysis for Cmax: 5-fluorouracil||1.40|0.92|
74052265|NCT01234337|147656439|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.29|||||TWO_SIDED|90.0|1.07|1.56||||||Statistical analysis for Cmax: Capecitabine||1.56|1.07|
74052266|NCT01234337|147656440|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.11|||||TWO_SIDED|90.0|0.95|1.3||||||Statistical analysis for AUC(0-tlast): 5-fluorouracil||1.30|0.95|
74052267|NCT01234337|147656440|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.39|||||TWO_SIDED|90.0|1.22|1.58||||||Statistical analysis for AUC(0-tlast): Capecitabine||1.58|1.22|
74052268|NCT03481634|147656442|NON_INFERIORITY|Non-inferiority (4-letter margin)|LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.81|<|0.001|TWO_SIDED|95.0|-2.9|0.3||1-sided p-value|ANOVA|||||0.3|-2.9|<0.001
74052269|NCT03481634|147656442|NON_INFERIORITY|Non-inferiority (4-letter margin)|LS mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.94||0.227|TWO_SIDED|95.0|-5.1|-1.4||1-sided p-value|ANOVA|||||-1.4|-5.1|0.227
74052270|NCT03481634|147656443|NON_INFERIORITY|Non-inferiority (4-letter margin)|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-3.0|0.0||(1-sided)|ANOVA|||||-0.0|-3.0|<0.001
74052271|NCT03481634|147656443|NON_INFERIORITY|Non-inferiority (4-letter margin)|Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-5.2|-1.7||(1-sided)|ANOVA|||||-1.7|-5.2|
74052272|NCT03481634|147656447|OTHER|Descriptive|LS mean difference|-3.8|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-6.0|-1.7|||ANOVA|||||-1.7|-6.0|
74052273|NCT03481634|147656447|OTHER|Descriptive|LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.0|0.1|||ANOVA|||||0.1|-4.0|
74052274|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|8.68|||TWO_SIDED|95.0|-17.7|16.4|||ANOVA|||Week 4||16.4|-17.7|
74052275|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-2.1|STANDARD_ERROR_OF_MEAN|8.41|||TWO_SIDED|95.0|-18.7|14.4|||ANOVA|||Week 4||14.4|-18.7|
74052276|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|12.2|STANDARD_ERROR_OF_MEAN|8.87|||TWO_SIDED|95.0|-5.2|29.7|||ANOVA|||Week 6||29.7|-5.2|
74052277|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|8.38|||TWO_SIDED|95.0|-14.0|18.9|||ANOVA|||Week 6||18.9|-14.0|
74052278|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|8.61|||TWO_SIDED|95.0|-16.0|17.9|||ANOVA|||Week 8||17.9|-16.0|
74052279|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.28|||TWO_SIDED|95.0|-19.6|12.9|||ANOVA|||Week 8||12.9|-19.6|
74052280|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|6.4|STANDARD_ERROR_OF_MEAN|8.73|||TWO_SIDED|95.0|-10.7|23.6|||ANOVA|||Week 12||23.6|-10.7|
74052281|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|8.85|||TWO_SIDED|95.0|-14.6|20.2|||ANOVA|||Week 12||20.2|-14.6|
74052282|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|8.5|||TWO_SIDED|95.0|-15.7|17.8|||ANOVA|||Week 16||17.8|-15.7|
73881528|NCT03192176|147297634|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|4.59||0.6404|TWO_SIDED|95.0|-6.89|11.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||11.17|-6.89|0.6404
73881529|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|4.45||0.8955|TWO_SIDED|95.0|-8.17|9.34||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.34|-8.17|0.8955
74052283|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.29|||TWO_SIDED|95.0|-19.7|12.9|||ANOVA|||Week 16||12.9|-19.7|
74052284|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|8.9|STANDARD_ERROR_OF_MEAN|8.92|||TWO_SIDED|95.0|-8.6|26.5|||ANOVA|||Week 18||26.5|-8.6|
74052285|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|8.47|||TWO_SIDED|95.0|-14.1|19.2|||ANOVA|||Week 18||19.2|-14.1|
74052286|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.55|||TWO_SIDED|95.0|-20.2|13.4|||ANOVA|||Week 20||13.4|-20.2|
74052287|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-5.8|STANDARD_ERROR_OF_MEAN|8.12|||TWO_SIDED|95.0|-21.7|10.2|||ANOVA|||Week 20||10.2|-21.7|
74052288|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-13.9|STANDARD_ERROR_OF_MEAN|9.06|||TWO_SIDED|95.0|-31.7|3.9|||ANOVA|||Week 24||3.9|-31.7|
74052289|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-17.8|STANDARD_ERROR_OF_MEAN|8.95|||TWO_SIDED|95.0|-35.4|-0.2|||ANOVA|||Week 24||-0.2|-35.4|
74052290|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-8.7|STANDARD_ERROR_OF_MEAN|8.26|||TWO_SIDED|95.0|-25.0|7.5|||ANOVA|||Week 28||7.5|-25.0|
74052291|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-8.7|STANDARD_ERROR_OF_MEAN|8.49|||TWO_SIDED|95.0|-25.4|8.0|||ANOVA|||Week 28||8.0|-25.4|
74052292|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|9.49|||TWO_SIDED|95.0|-21.8|15.5|||ANOVA|||Week 32||15.5|-21.8|
74099600|NCT03301623|147748412|SUPERIORITY||Mean Difference (Net)|-0.69||||0.541|TWO_SIDED|95.0|-2.9|1.52|||Mixed Models Analysis|Test is on interaction term between time (pre/post intervention) and treatment group (CDSvsPEAT) dummy variables in the regression model.|The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in reducing pain interference over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level."||1.52|-2.9|.541
73881530|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|4.59||0.9776|TWO_SIDED|95.0|-8.91|9.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.17|-8.91|0.9776
73881531|NCT03192176|147297634|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|4.14||0.7852|TWO_SIDED|95.0|-9.27|7.01||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||7.01|-9.27|0.7852
74052293|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-11.7|STANDARD_ERROR_OF_MEAN|9.02|||TWO_SIDED|95.0|-29.5|6.0|||ANOVA|||Week 32||6.0|-29.5|
74052294|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|36.3|STANDARD_ERROR_OF_MEAN|11.01|||TWO_SIDED|95.0|14.6|57.9|||ANOVA|||Week 36||57.9|14.6|
74052295|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|9.97|||TWO_SIDED|95.0|0.7|40.0|||ANOVA|||Week 36||40.0|0.7|
74052296|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-6.1|STANDARD_ERROR_OF_MEAN|9.19|||TWO_SIDED|95.0|-24.2|11.9|||ANOVA|||Week 40||11.9|-24.2|
74052297|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-6.5|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-25.2|12.2|||ANOVA|||Week 40||12.2|-25.2|
74052298|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|9.33|||TWO_SIDED|95.0|-10.4|26.3|||ANOVA|||Week 44||26.3|-10.4|
74052299|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-16.2|18.3|||ANOVA|||Week 44||18.3|-16.2|
74052300|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|13.6|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-5.8|32.9|||ANOVA|||Week 48||32.9|-5.8|
74052301|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|9.26|||TWO_SIDED|95.0|-13.5|23.0|||ANOVA|||Week 48||23.0|-13.5|
74052302|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|9.52|||TWO_SIDED|95.0|-14.5|23.0|||ANOVA|||Week 52||23.0|-14.5|
74052303|NCT03481634|147656450|OTHER|Descriptive|LS mean difference|-5.1|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-22.3|12.2|||ANOVA|||Week 52||12.2|-22.3|
74052304|NCT03481634|147656451|OTHER|Descriptive|LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-16.6|20.0|||ANOVA|||||20.0|-16.6|
74052305|NCT03481634|147656451|OTHER|Descriptive|LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|8.79|||TWO_SIDED|95.0|-20.7|13.8|||ANOVA|||||13.8|-20.7|
74052306|NCT03481634|147656458|OTHER|Descriptive; Week 28|Difference - %|1.6|||||TWO_SIDED|95.0|-5.3|8.4|||Bootstrap method|||||8.4|-5.3|
74052307|NCT03481634|147656458|OTHER|Descriptive; Week 28|Difference - %|4.1|||||TWO_SIDED|95.0|-2.1|10.3|||Bootstrap method|||||10.3|-2.1|
74052308|NCT03481634|147656458|OTHER|Descriptive; Week 52|Difference - %|5.8|||||TWO_SIDED|95.0|-1.2|12.4|||Bootstrap method|||||12.4|-1.2|
74052309|NCT03481634|147656458|OTHER|Descriptive; Week 52|Difference - %|6.7|||||TWO_SIDED|95.0|0.6|12.9|||Bootstrap method|||||12.9|0.6|
74052310|NCT03481634|147656458|OTHER|Descriptive: Week 76|Difference - %|2.8|||||TWO_SIDED|95.0|-3.9|9.4|||Bootstrap method|||||9.4|-3.9|
74052311|NCT03481634|147656458|OTHER|Descriptive: Week 76|Difference - %|0.7|||||TWO_SIDED|95.0|-5.7|7.0|||Bootstrap method|||||7.0|-5.7|
74052312|NCT03481634|147656458|OTHER|Descriptive: Week 100|Difference - %|1.7|||||TWO_SIDED|95.0|-5.0|8.1|||Bootstrap method|||||8.1|-5.0|
74052313|NCT03481634|147656458|OTHER|Descriptive: Week 100|Difference - %|2.2|||||TWO_SIDED|95.0|-4.0|8.4|||Bootstrap method|||||8.4|-4.0|
74052314|NCT03481634|147656460|OTHER|Descriptive; Week 28|Difference - %|-0.3|||||TWO_SIDED|95.0|-6.4|5.8|||Bootstrap method|||||5.8|-6.4|
74052315|NCT03481634|147656460|OTHER|Descriptive; Week 28|Difference - %|4.6|||||TWO_SIDED|95.0|-1.3|11.0|||Bootstrap method|||||11.0|-1.3|
74052316|NCT03481634|147656460|OTHER|Descriptive; Week 52|Difference - %|-4.2|||||TWO_SIDED|95.0|-10.2|2.2|||Bootstrap method|||||2.2|-10.2|
74052317|NCT03481634|147656460|OTHER|Descriptive; Week 52|Difference - %|3.9|||||TWO_SIDED|95.0|-2.2|10.5|||Bootstrap method|||||10.5|-2.2|
74052318|NCT03481634|147656460|OTHER|Descriptive; Week 72|Difference - %|-9.2|||||TWO_SIDED|95.0|-15.5|-2.8|||Bootstrap method|||||-2.8|-15.5|
74052319|NCT03481634|147656460|OTHER|Descriptive; Week 72|Difference - %|-2.3|||||TWO_SIDED|95.0|-8.4|4.4|||Bootstrap method|||||4.4|-8.4|
74052320|NCT03481634|147656460|OTHER|Descriptive; Week 100|Difference - %|-7.7|||||TWO_SIDED|95.0|-14.0|-1.6|||Bootstrap method|||||-1.6|-14.0|
74052321|NCT03481634|147656460|OTHER|Descriptive; Week 100|Difference - %|0.4|||||TWO_SIDED|95.0|-5.7|6.8|||Bootstrap method|||||6.8|-5.7|
74052322|NCT00792922|147656535|SUPERIORITY|Predicted prevalence was estimated in each community using the baseline observed prevalence, treatment arm \& parameters estimated from square root transformed model.For each arm estimated prevalences were averaged.Difference in adjusted mean prevalence for enhanced arm and standard arm was calculated.For confidence intervals for adjusted difference,steps 1 to 4 for 1000 bootstrap samples were repeated.Median of adjusted mean differences, corresponding 2.5 % \& 97.5 % percentiles were reported.|Mean Difference (Final Values)|1.4||||0.22|TWO_SIDED|95.0|-1.0|3.8|||Regression, Linear|||"This is analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."||3.8|-1|0.22
74052323|NCT00792922|147656535|SUPERIORITY|For each community using the baseline observed prevalence, treatment arm and parameters estimated from square root transformed model we estimated predicted prevalence.For each arm we average estimated prevalences.The difference in the adjusted mean prevalence for enhanced arm and standard arm was then calculated.In order to derive the confidence intervals for the adjusted difference, we repeated Steps 1 to 4 for 1000 bootstrap samples.The median of the adjusted mean differences were reported.|Mean Difference (Final Values)|2.6||||0.73|TWO_SIDED|95.0|-0.3|5.3|||Ordinary least squares linear regression|||"This is the analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.~Here we are looking at the prevalence of trachoma"||5.3|-0.3|0.73
74052324|NCT00792922|147656535|SUPERIORITY||Median Difference (Final Values)|-4.6||||0.2|TWO_SIDED|95.0|-11.1|1.9|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."||1.9|-11.1|0.20
74052325|NCT00792922|147656535|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.6|TWO_SIDED|95.0|-7.7|12.5|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of trachoma."||12.5|-7.7|0.60
74052326|NCT00247962|147656537|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.99|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74052327|NCT00247962|147656538|SUPERIORITY_OR_OTHER|||||||0.719|||||||ANCOVA|||baseline||||0.719
74052328|NCT00247962|147656538|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|||week 16||||0.010
74052329|NCT01469637|147656545|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|1.15|||||TWO_SIDED|90.0|1.12|1.18|||ANOVA|||||1.18|1.12|
74052330|NCT01469637|147656546|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|1.09|1.15|||ANOVA|||||1.15|1.09|
74052331|NCT00598585|147656547|SUPERIORITY|unpaired test, the threshold for statistical significance was p= 0.05|||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
74052332|NCT01084096|147656570|SUPERIORITY|Trial powered to detect a 30% reduction in 28-d NM among \<5th %tile for birth weight infants. We used an intention-to-treat approach, with a model-based adaptation of the permutation test. We fitted an individual-level linear model with 28-d NM by site and randomization strata, nested within site, and computed the residual for each individual and mean cluster-level residuals. Next, we used an ANOVA model to test for trt differences between mean residuals for intervention and control clusters.|Risk Ratio (RR)|0.96||||0.65|TWO_SIDED|95.0|0.87|1.06|||t-test, 2 sided|Cluster-level with 62 degrees of freedom \[101 clusters-37 strata-2 treatment groups\].|Calculated from generalized linear models accounting for the cluster-level variance and adjusted for randomization strata. Each stratum corresponds to 2-4 clusters within the site with equal distribution to treatment and control arms.|||1.06|0.87|0.65
74052333|NCT01084096|147656571|SUPERIORITY||Risk Difference (RD)|0.3546|||<|0.0001|TWO_SIDED|95.0|0.3299|0.3792|||Cochran-Mantel-Haenszel|P-values were calculated from Cochran-Mantel-Haenszel test controlling for randomization strata.|Risk difference represents risk in the intervention clusters minus the risk in the control clusters.|The trial was powered to detect a 30% reduction in 28-day neonatal mortality among infants born at less than the 5th percentile of birth weight, based on previous research and an expected increase from 10% to 50% in the use of antenatal corticosteroids among women at risk of preterm birth in the intervention group.||0.3792|0.3299|<0.0001
74052334|NCT01084096|147656572|OTHER|Descriptive analysis.|Odds Ratio (OR)|1.45|||<|0.0001|TWO_SIDED|95.0|1.33|1.58||P-values were calculated from Cochran-Mantel-Haenszel test controlling for randomization strata.|Cochran-Mantel-Haenszel|||||1.58|1.33|<0.0001
74052335|NCT01084096|147656574|SUPERIORITY||Risk Ratio (RR)|1.12||||0.0127|TWO_SIDED|95.0|1.02|1.22||P-value calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated p value was adjusted for randomization strata.|Generalized linear model with GEE||Relative risk calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated measure of risk was adjusted for randomization strata.|||1.22|1.02|0.0127
74052336|NCT01084096|147656575|OTHER|Descriptive analysis.|Risk Ratio (RR)|1.11||||0.0181|TWO_SIDED|95.0|1.02|1.22||P-value calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated p value was adjusted for randomization strata.|Generalized linear model with GEE||Relative risk calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated measure of risk was adjusted for randomization strata.|||1.22|1.02|0.0181
74052337|NCT04450394|147656588|NON_INFERIORITY|The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% Confidence Interval is below 0.4.|LS Mean Difference|0.06|||||TWO_SIDED|90.0|-0.11|0.24||||||||0.24|-0.11|
74052338|NCT00836342|147656592|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||Null hypothesis: There is no difference in mean carotenoid levels between subjects with a history of squamous cell carcinom and control subjects.||||0.31
74052339|NCT00836342|147656593|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
74052340|NCT00836342|147656594|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
74052341|NCT02155660|147656596|SUPERIORITY||Rate ratio|0.85||||0.0638|TWO_SIDED|95.0|0.71|1.01|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.01|0.71|0.0638
74052342|NCT02155660|147656596|SUPERIORITY||Rate ratio|1.04||||0.6575|TWO_SIDED|95.0|0.88|1.23|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.23|0.88|0.6575
74052343|NCT02155660|147656596|SUPERIORITY||Rate ratio|0.93||||0.3988|TWO_SIDED|95.0|0.78|1.1|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.10|0.78|0.3988
74052344|NCT02155660|147656597|SUPERIORITY||Rate ratio|1.04||||0.7564|TWO_SIDED|95.0|0.82|1.32|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.32|0.82|0.7564
74052345|NCT02155660|147656597|SUPERIORITY||Rate ratio|1.08||||0.5573|TWO_SIDED|95.0|0.84|1.37|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.37|0.84|0.5573
74052346|NCT02155660|147656597|SUPERIORITY||Rate ratio|1.02||||0.8644|TWO_SIDED|95.0|0.8|1.3|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.30|0.80|0.8644
74052347|NCT02155660|147656598|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.5043|TWO_SIDED|95.0|-0.029|0.059|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.059|-0.029|0.5043
74052348|NCT02155660|147656598|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.7691|TWO_SIDED|95.0|-0.051|0.037|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.037|-0.051|0.7691
73888140|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|8.3||||0.0075|TWO_SIDED|95.0|2.3|14.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.4|2.3|0.0075
74052349|NCT02155660|147656598|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.3767|TWO_SIDED|95.0|-0.024|0.064|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.064|-0.024|0.3767
74052350|NCT02155660|147656599|SUPERIORITY||Mean Difference (Final Values)|-1.011||||0.3636|TWO_SIDED|95.0|-3.192|1.171|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||1.171|-3.192|0.3636
74052351|NCT02155660|147656599|SUPERIORITY||Mean Difference (Final Values)|-1.388||||0.2106|TWO_SIDED|95.0|-3.562|0.786|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.786|-3.562|0.2106
74052352|NCT02155660|147656599|SUPERIORITY||Mean Difference (Final Values)|-0.602||||0.5851|TWO_SIDED|95.0|-2.763|1.56|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||1.560|-2.763|0.5851
74052353|NCT02155660|147656600|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.8525|TWO_SIDED|95.0|-0.82|0.99|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.99|-0.82|0.8525
74052354|NCT02155660|147656600|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.987|TWO_SIDED|95.0|-0.91|0.89|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.89|-0.91|0.9870
74052355|NCT02155660|147656600|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.8204|TWO_SIDED|95.0|-1.0|0.79|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.79|-1.00|0.8204
74052356|NCT02155660|147656601|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2636|TWO_SIDED|95.0|-1.102|0.301|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.301|-1.102|0.2636
74052357|NCT02155660|147656601|SUPERIORITY||Mean Difference (Final Values)|-0.296||||0.4087|TWO_SIDED|95.0|-0.998|0.406|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.406|-0.998|0.4087
74052358|NCT02155660|147656601|SUPERIORITY||Mean Difference (Final Values)|-0.425||||0.2336|TWO_SIDED|95.0|-1.125|0.275|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.275|-1.125|0.2336
74052359|NCT02155660|147656602|SUPERIORITY||Mean Difference (Final Values)|-0.642||||0.0012|TWO_SIDED|95.0|-1.029|-0.254|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.254|-1.029|0.0012
74052360|NCT02155660|147656602|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0852|TWO_SIDED|95.0|-0.727|0.047|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.047|-0.727|0.0852
74052361|NCT02155660|147656602|SUPERIORITY||Mean Difference (Final Values)|-0.364||||0.065|TWO_SIDED|95.0|-0.75|0.023|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.023|-0.750|0.0650
74052362|NCT02155660|147656603|SUPERIORITY||Mean Difference (Final Values)|-0.041||||0.0415|TWO_SIDED|95.0|-0.081|-0.002|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.002|-0.081|0.0415
74052363|NCT02155660|147656603|SUPERIORITY||Mean Difference (Final Values)|-0.055||||0.0069|TWO_SIDED|95.0|-0.094|-0.015|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.015|-0.094|0.0069
74052364|NCT02155660|147656603|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.2008|TWO_SIDED|95.0|-0.065|0.014|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.014|-0.065|0.2008
74052365|NCT02155660|147656607|SUPERIORITY||Rate ratio|0.98||||0.8158|TWO_SIDED|95.0|0.81|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.18|0.81|0.8158
74052366|NCT02155660|147656607|SUPERIORITY||Rate ratio|0.98||||0.8378|TWO_SIDED|95.0|0.82|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.18|0.82|0.8378
74052367|NCT02155660|147656607|SUPERIORITY||Rate ratio|0.92||||0.3759|TWO_SIDED|95.0|0.76|1.11|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.11|0.76|0.3759
74052368|NCT02155660|147656608|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9141|TWO_SIDED|95.0|0.76|1.36|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.36|0.76|0.9141
74052369|NCT02155660|147656608|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0323|TWO_SIDED|95.0|1.03|1.87|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.87|1.03|0.0323
74052370|NCT02155660|147656608|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5109|TWO_SIDED|95.0|0.82|1.48|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.48|0.82|0.5109
74052371|NCT02155660|147656610|SUPERIORITY||Rate ratio|0.68||||0.0287|TWO_SIDED|95.0|0.49|0.96|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.96|0.49|0.0287
74052372|NCT02155660|147656610|SUPERIORITY||Rate ratio|0.89||||0.4631|TWO_SIDED|95.0|0.65|1.22|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||1.22|0.65|0.4631
74052373|NCT02155660|147656610|SUPERIORITY||Rate ratio|0.67||||0.0185|TWO_SIDED|95.0|0.48|0.94|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.94|0.48|0.0185
74052374|NCT01192139|147656615|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin|Ratio of Geometric Least Squares Means|1.039|||||TWO_SIDED|90.0|1.011|1.068|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.068|1.011|
74052375|NCT01192139|147656615|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Means|1.078|||||TWO_SIDED|90.0|1.049|1.108|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.108|1.049|
74052376|NCT01192139|147656615|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|104.65||||||95.0||||||||Geometric least squares means for treatment A||||
74052377|NCT01192139|147656615|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|108.74||||||95.0||||||||Geometric least squares means for treatment B||||
74052378|NCT01192139|147656615|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|100.84||||||95.0||||||||Geometric least squares mean for treatment C||||
74052379|NCT01192139|147656617|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|1.039|||||TWO_SIDED|90.0|1.011|1.068|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||1.068|1.011|
74052380|NCT01192139|147656617|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|1.051|1.11|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.110|1.051|
74052381|NCT01192139|147656617|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|102.84||||||95.0||||||||Geometric least squares mean for treatment A||||
74052382|NCT01192139|147656617|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|106.89||||||95.0||||||||Geometric least squares mean for treatment B||||
74052383|NCT01192139|147656617|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|98.99||||||95.0||||||||Geometric least squares mean for treatment C||||
73881532|NCT03192176|147297634|SUPERIORITY||LSMean difference|1.2|STANDARD_ERROR_OF_MEAN|4.15||0.7812|TWO_SIDED|95.0|-7.02|9.33||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||9.33|-7.02|0.7812
73881533|NCT03192176|147297634|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|4.23||0.2648|TWO_SIDED|95.0|-13.07|3.61||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||3.61|-13.07|0.2648
73881534|NCT03192176|147297634|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|4.25||0.6312|TWO_SIDED|95.0|-10.41|6.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||6.32|-10.41|0.6312
73881535|NCT03192176|147297634|SUPERIORITY||LSMean difference|1.4|STANDARD_ERROR_OF_MEAN|4.2||0.7416|TWO_SIDED|95.0|-6.89|9.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||9.67|-6.89|0.7416
73881536|NCT03192176|147297634|SUPERIORITY||LSMean difference|3.3|STANDARD_ERROR_OF_MEAN|4.12||0.4254|TWO_SIDED|95.0|-4.83|11.41||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||11.41|-4.83|0.4254
74052384|NCT01192139|147656618|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of Geometric Least Squares Means|1.021|||||TWO_SIDED|90.0|0.94|1.109|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.109|0.940|
74052385|NCT01192139|147656618|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the fed to fasted ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin.|Ratio of Geometric Least Squares Means|0.949|||||TWO_SIDED|90.0|0.873|1.031|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.031|0.873|
74052386|NCT01192139|147656618|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|25.68||||||95.0||||||||Geometric least squares mean for treatment A||||
74052387|NCT01192139|147656618|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|26.21||||||95.0||||||||Geometric least squares mean for treatment B||||
74052388|NCT01192139|147656618|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|27.63||||||95.0||||||||Geometric least squares mean for treatment C||||
73881537|NCT03192176|147297634|SUPERIORITY||LSMean difference|3.4|STANDARD_ERROR_OF_MEAN|4.11||0.4038|TWO_SIDED|95.0|-4.66|11.54||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||11.54|-4.66|0.4038
73881538|NCT03192176|147297634|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|4.91||0.327|TWO_SIDED|95.0|-14.49|4.85||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||4.85|-14.49|0.3270
73881539|NCT03192176|147297634|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|4.85||0.7333|TWO_SIDED|95.0|-11.21|7.9||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||7.90|-11.21|0.7333
73881540|NCT03192176|147297634|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|4.99||0.1319|TWO_SIDED|95.0|-17.36|2.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||2.28|-17.36|0.1319
74052389|NCT01192139|147656627|NON_INFERIORITY_OR_EQUIVALENCE|BE concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Geometric Means|0.915|||||TWO_SIDED|90.0|0.836|1.002|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.002|0.836|
74052390|NCT01192139|147656627|NON_INFERIORITY_OR_EQUIVALENCE|lack of food effect concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Geometric LS Mean and 90% CI|1.01|||||TWO_SIDED|90.0|0.918|1.111|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.111|0.918|
74052391|NCT01192139|147656627|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5542.2||||||95.0||||||||Geometric least squares means for treatment A||||
74052392|NCT01192139|147656627|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5072.9||||||95.0||||||||Geometric least squares mean for treatment B||||
74052393|NCT01192139|147656627|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5023.3||||||95.0||||||||Geometric least squares mean for treatment C||||
74052394|NCT01192139|147656628|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|0.92|||||TWO_SIDED|90.0|0.854|0.992|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||0.992|0.854|
74052395|NCT01192139|147656628|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.025|||||TWO_SIDED|95.0|0.951|1.105|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.105|0.951|
73881541|NCT03192176|147297634|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|5.0||0.6132|TWO_SIDED|95.0|-12.38|7.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||7.32|-12.38|0.6132
73881542|NCT03192176|147297634|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|4.98||0.4024|TWO_SIDED|95.0|-13.98|5.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||5.63|-13.98|0.4024
74052396|NCT01192139|147656628|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5287.1||||||95.0||||||||Geometric least squares means for treatment A||||
74052397|NCT01192139|147656628|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|4866.2||||||95.0||||||||Geometric least squares mean for treatment B||||
74052398|NCT01192139|147656628|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|4746.8||||||95.0||||||||Geometric least squares means for treatment C||||
74052399|NCT01192139|147656629|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|Ratio of Geometric Least Squares Means|0.933|||||TWO_SIDED|95.0|0.865|1.007|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.007|0.865|
73881543|NCT03192176|147297634|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|4.88||0.4904|TWO_SIDED|95.0|-12.97|6.23||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||6.23|-12.97|0.4904
73888141|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6||||0.1354|TWO_SIDED|95.0|-1.5|10.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.7|-1.5|0.1354
74052400|NCT01192139|147656629|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(inf) of saxagliptin and metformin.|Ratio of Geometric Least Squares Means|0.898|||||TWO_SIDED|90.0|0.832|0.969|||||Ration = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||0.969|0.832|
74052401|NCT01192139|147656629|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|608.41||||||95.0||||||||Geometric least squares mean for treatment A||||
74052402|NCT01192139|147656629|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|567.85||||||95.0||||||||Geometric least squares mean for treatment B||||
74052403|NCT01192139|147656629|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|632.39||||||95.0||||||||Geometric least squares mean for treatment C||||
74052404|NCT03812224|147656635|SUPERIORITY||LS Mean Difference|-1.62|||<|0.001||95.0|-2.52|-0.73|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of migraine type and prior migraine preventive treatment status, and baseline value as covariates and assumes a first-order auto regression covariance structure.||-0.73|-2.52|<0.001
74052405|NCT03812224|147656636|SUPERIORITY||Odds Ratio (OR)|2.33||||0.005|TWO_SIDED|95.0|1.29|4.23|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factors of migraine type and prior migraine preventive treatment status.||||4.23|1.29|0.005
74052406|NCT03812224|147656637|SUPERIORITY||LS Mean Difference|-1.47|||<|0.001||95.0|-2.24|-0.71|||Generalized Linear Mixed Model|||Analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of migraine type (episodic migraine or chronic migraine) and prior migraine preventive treatment status (ever used or never used), and baseline value as covariates and assumes a first-order auto regression covariance structure.||-0.71|-2.24|<0.001
74052407|NCT02643420|147656694|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|-0.148|||<|0.0001|TWO_SIDED|95.0|-0.266|-0.031|||t-statistics|The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.||||-0.031|-0.266|<0.0001
74052408|NCT02643420|147656695|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.685|TWO_SIDED|95.0|-1.43|0.94|||Negative binomial regression|||||0.94|-1.43|0.685
74052409|NCT02643420|147656696|SUPERIORITY||Median Difference (Final Values)|1.2||||0.155|TWO_SIDED|95.0|0.93|1.56|||Asymptotic normality assumption|P-value was obtained based upon asymptotic normality assumption on the log10 transformed data.||||1.56|0.93|0.155
74052410|NCT02643420|147656697|SUPERIORITY||Percent Difference|1.1||||0.435|TWO_SIDED|95.0|-8.6|10.8|||Fisher Exact|||||10.8|-8.6|0.435
74052411|NCT02643420|147656698|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.042|||<|0.0001|TWO_SIDED|95.0|-0.032|0.116|||t-statistics|||DSN in Cycle 2||0.116|-0.032|<0.0001
74052412|NCT02643420|147656698|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.026|||<|0.0001|TWO_SIDED|95.0|-0.032|0.085|||t-statistics|||DSN in Cycle 3||0.085|-0.032|<0.0001
74052413|NCT02643420|147656698|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.027|||<|0.0001|TWO_SIDED|95.0|-0.036|0.089|||t-statistics|||DSN in Cycle 4||0.089|-0.036|<0.0001
74052414|NCT02643420|147656699|SUPERIORITY||Percent Difference|0.3||||1|TWO_SIDED|95.0|-9.5|10.0|||Fisher Exact|||||10.0|-9.5|1.000
74052415|NCT02643420|147656700|SUPERIORITY||Percent Difference|0.0||||1|TWO_SIDED|95.0|-9.7|9.8|||Fisher Exact|||FN in Cycle 2||9.8|-9.7|1.000
74052416|NCT02643420|147656700|SUPERIORITY||Percent Difference|1.6||||0.201|TWO_SIDED|95.0|-8.2|11.3|||Fisher Exact|||FN in Cycle 3||11.3|-8.2|0.201
74052417|NCT02643420|147656700|SUPERIORITY||Percent Difference|1.0||||0.232|TWO_SIDED|95.0|-8.7|10.8|||Fisher Exact|||FN in Cycle 4||10.8|-8.7|0.232
74052418|NCT02127970|147656703|NON_INFERIORITY|The non-inferiority hypothesis test was to be a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in responder rates is greater than -10%, then the single-dose dalbavancin regimen was to be declared non-inferior to the two dose dalbavancin regimen.|Difference|-2.9|||||TWO_SIDED|95.0|-8.5|2.8|||||For the difference in clinical responder rates (single-dose group minus two dose group), the 95% CI was calculated using the Miettinen and Nurminen method without adjustment.|||2.8|-8.5|
74052419|NCT02988115|147656715|SUPERIORITY||Least squares means difference|-21.41|STANDARD_ERROR_OF_MEAN|1.897|<|0.001|TWO_SIDED|95.0|-25.132|-17.697|||ANCOVA||bempedoic acid (BA) therapy minus placebo|||-17.697|-25.132|<0.001
74052420|NCT02988115|147656716|SUPERIORITY||Least squares means difference|-18.91|STANDARD_ERROR_OF_MEAN|2.063|<|0.001|TWO_SIDED|95.0|-22.951|-14.865|||ANCOVA||BA therapy minus placebo|||-14.865|-22.951|<0.001
74052421|NCT02988115|147656717|SUPERIORITY||Least squares means difference|-17.94|STANDARD_ERROR_OF_MEAN|1.597|<|0.001|TWO_SIDED|95.0|-21.07|-14.811|||ANCOVA||BA therapy minus placebo|non-HDL-C||-14.811|-21.070|<0.001
74052422|NCT02988115|147656717|SUPERIORITY||Least squares means difference|-14.76|STANDARD_ERROR_OF_MEAN|1.287|<|0.001|TWO_SIDED|95.0|-17.283|-12.239|||ANCOVA||BA therapy minus placebo|TC||-12.239|-17.283|<0.001
74052423|NCT02988115|147656717|SUPERIORITY||Least squares means difference|-14.96|STANDARD_ERROR_OF_MEAN|1.581|<|0.001|TWO_SIDED|95.0|-18.062|-11.866|||ANCOVA||BA therapy minus placebo|apoB||-11.866|-18.062|<0.001
74052424|NCT02988115|147656718|SUPERIORITY||Median treatment difference|-24.29|STANDARD_ERROR_OF_MEAN|-24.3|<|0.001|TWO_SIDED|95.0|-35.888|-12.712|||Wilcoxon rank sum test||BA therapy minus placebo|||-12.712|-35.888|<0.001
74052425|NCT02364999|147656752|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk difference for confirmed response. EU equivalence margins (95% CI in -13% to 13%).|Risk Difference (RD)|0.6531|||||TWO_SIDED|95.0|-6.608|7.9082|||||PF-06439535 vs Bevacizumab-EU|||7.9082|-6.6080|
74052426|NCT02364999|147656752|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. US equivalence margins (90% CI in 0.73 to 1.37).|Risk Ratio (RR)|1.0146|||||TWO_SIDED|90.0|0.8856|1.1625|||||PF-06439535 vs Bevacizumab-EU|||1.1625|0.8856|
74052427|NCT02364999|147656752|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. Japan equivalence margins (95% CI in 0.729 to 1.371).|Risk Ratio (RR)|1.0146|||||TWO_SIDED|95.0|0.8628|1.1933|||||PF-06439535 vs Bevacizumab-EU|||1.1933|0.8628|
74052428|NCT02364999|147656755|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.8||||0.1077|TWO_SIDED|95.0|0.608|1.051|||Log Rank|Stratified by smoking, sex and region.||||1.051|0.608|0.1077
74099601|NCT03301623|147748413|SUPERIORITY||Odds Ratio (OR)|2.96||||0.019|TWO_SIDED|95.0|1.2|7.31|||Regression, Logistic|There were 69 providers with at least one CG-CAHPS response.|The interaction term describes the change in the PEAT group's scores in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in improving how satisfied patients feel over time after communicating with their physician about chronic pain treatment risks and benefits?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level."||7.31|1.20|.019
73881544|NCT03192176|147297634|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|4.87||0.5521|TWO_SIDED|95.0|-12.48|6.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||6.69|-12.48|0.5521
74052429|NCT02364999|147656756|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.931||||0.4492||95.0|0.777|1.116|||Log Rank|Stratified by smoking, sex and region.||||1.116|0.777|0.4492
74052430|NCT02364999|147656757|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.918||||0.4726|TWO_SIDED|95.0|0.729|1.157|||Log Rank|Stratified by smoking, sex and region.||||1.157|0.729|0.4726
74052431|NCT03459794|147656761|OTHER|||||||||||||||||All measurements were compared to the same group at t=0, that is before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We analyzed the changes is level for each cytokine between the groups. P value was adjusted for multiple comparisons and significance determined using the Holm-Sidak method. The threshold value for statistical significance for the mean value between groups was set at p =\<0.05 for each cytokine measured. The number of cytokines that met this threshold is reported.|||
74052432|NCT03459794|147656762|OTHER|||||||||||||||||All measurements were compared to the same treated/control group at t=0, before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level. The p-value for each transcript is adjusted for multiple comparisons across all 770 transcripts, using the Benjamini-Yekutieli method. The number reported is the number of transcripts where p=\<0.05.|||
74052433|NCT03459794|147656763|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
74052434|NCT02177942|147656765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.6931|TWO_SIDED|95.0|-0.2|0.13|||ANCOVA||Difference is test treatment minus control treatment such that a positive difference favours the test treatment.|||0.13|-0.20|0.6931
74052435|NCT02607735|147656793|SUPERIORITY|The SVR12 rate for the SOF/VEL/VOX group was compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|||||<|0.001|||||||2-sided exact 1-sample binomial test|||||||<0.001
74099602|NCT03301623|147748414|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.719|TWO_SIDED|95.0|-2.73|1.88|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in improving physical function over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level."||1.88|-2.73|.719
74099603|NCT03301623|147748415|SUPERIORITY||Odds Ratio (OR)|1.63||||0.01|TWO_SIDED|95.0|1.13|2.36|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in reducing opioid prescriptions of more than 90 morphine milligrams equivalent (MME) over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level."||2.36|1.13|.010
74099604|NCT03301623|147748416|SUPERIORITY||Odds Ratio (OR)|0.76||||0.51|TWO_SIDED|95.0|0.34|1.71|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|Question: Which communication strategy used during the clinical encounter is more effective in reducing co-prescription of opioids and benzodiazepines over time for patients with chronic pain who were taking opioids at baseline?||1.71|.34|.510
74019353|NCT02058147|147590891|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.185|<|0.0001|TWO_SIDED|95.0|-2.498|-1.77||Threshold for significance ≤0.05. The hierarchical testing continued only when primary hypotheses (superiority: FRC to lixisenatide; non-inferiority: FRC to insulin glargine for HbA1c) was statistically significant.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0,≥8.0%), randomization strata of second OAD use at screening \& country as fixed effects \& baseline plasma glucose excursion value as a covariate. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order.||-1.77|-2.498|<0.0001
74052436|NCT02430389|147656804|SUPERIORITY_OR_OTHER|||||||0.0575|TWO_SIDED||||||t-test, 2 sided|||||||.0575
74052437|NCT02430389|147656805|SUPERIORITY_OR_OTHER|||||||0.348|TWO_SIDED||||||t-test, 2 sided|||||||.348
74052438|NCT02394028|147656817|SUPERIORITY||Difference in rate|1.1||||0.8508|TWO_SIDED|95.0|-10.85|12.56||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||12.56|-10.85|0.8508
74052439|NCT02394028|147656817|SUPERIORITY||Difference in rate|3.8||||0.5235|TWO_SIDED|95.0|-8.3|15.27||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||15.27|-8.30|0.5235
74052440|NCT02394028|147656819|SUPERIORITY||Difference in rate|4.9||||0.7908|TWO_SIDED|95.0|-6.26|16.11||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||16.11|-6.26|0.7908
74052441|NCT02394028|147656819|SUPERIORITY||Difference in rate|5.8||||0.317|TWO_SIDED|95.0|-5.43|17.05||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||17.05|-5.43|0.3170
74052442|NCT02394028|147656820|SUPERIORITY||Difference in rate|11.3||||0.0088|TWO_SIDED|95.0|2.7|19.65||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||19.65|2.70|0.0088
74052443|NCT02394028|147656821|SUPERIORITY||Difference in rate|11.5||||0.0026|TWO_SIDED|95.0|4.11|18.83||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||18.83|4.11|0.0026
74052444|NCT02394028|147656823|SUPERIORITY||Difference in rate|3.1||||1|TWO_SIDED|95.0|-8.02|13.45||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||13.45|-8.02|1
74052445|NCT02394028|147656823|SUPERIORITY||Difference in rate|2.3||||0.7908|TWO_SIDED|95.0|-8.78|12.56||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||12.56|-8.78|0.7908
74052446|NCT02394028|147656825|SUPERIORITY||Difference in rate|1.6||||1|TWO_SIDED|95.0|-6.51|9.73||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||9.73|-6.51|1
74052447|NCT02394028|147656825|SUPERIORITY||Difference in rate|6.5||||0.5235|TWO_SIDED|95.0|-2.24|15.16||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||15.16|-2.24|0.5235
74052448|NCT02394028|147656826|SUPERIORITY||Difference in LSM|-0.5||||0.311|TWO_SIDED|90.0|-1.4|0.3|||MMRM|||Bowel Domain Score||0.3|-1.4|0.3110
74052449|NCT02394028|147656827|SUPERIORITY||Difference in LSM|0.2||||1|TWO_SIDED|95.0|-0.5|0.9||The multiplicity adjusted p-values are presented.|MMRM|||Functional Domain Scale||0.9|-0.5|1
74052450|NCT02394028|147656827|SUPERIORITY||Difference in LSM|0.0||||1|TWO_SIDED|95.0|-0.7|0.7||The multiplicity adjusted p-values are presented.|MMRM|||Functional Domain Score||0.7|-0.7|1
74052451|NCT02394028|147656827|SUPERIORITY||Difference in LSM|0.1||||1|TWO_SIDED|95.0|-0.8|0.9||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Domain Score||0.9|-0.8|1
74052452|NCT02394028|147656827|SUPERIORITY||Difference in LSM|-0.3||||1|TWO_SIDED|95.0|-1.1|0.5||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Domain Score||0.5|-1.1|1
74052453|NCT02394028|147656828|SUPERIORITY||Difference in rate|17.3||||0.0677|TWO_SIDED|95.0|3.52|30.27||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||30.27|3.52|0.0677
74052454|NCT02394028|147656829|SUPERIORITY||Difference in rates|18.6||||0.048|TWO_SIDED|95.0|11.07|25.96||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||25.96|11.07|0.0480
74052455|NCT02394028|147656830|SUPERIORITY||Difference in rates|13.5||||0.121|TWO_SIDED|95.0|-2.9|29.94|||Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||29.94|-2.90|0.1210
74052456|NCT02394028|147656831|SUPERIORITY||Difference in rates|6.2||||0.048|TWO_SIDED|95.0|0.54|11.93||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||11.93|0.54|0.0480
74052457|NCT02394028|147656832|SUPERIORITY||Difference in rates|11.2||||0.0677|TWO_SIDED|95.0|3.04|19.24||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||19.24|3.04|0.0677
74052458|NCT02394028|147656833|SUPERIORITY||Difference in rates|16.2||||0.0035|TWO_SIDED|95.0|8.96|23.31||Nominal p-value, no adjustment for multiplicity performed.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||23.31|8.96|0.0035
74052459|NCT02394028|147656834|SUPERIORITY||Difference in LSM|-0.3||||0.4009|TWO_SIDED|95.0|-0.9|0.4||The multiplicity adjusted p-values are presented.|MMRM|||Functional Symptoms Domain||0.4|-0.9|0.4009
74052460|NCT02394028|147656834|SUPERIORITY||Difference in LSM|-0.3||||0.4009|TWO_SIDED|95.0|-1.0|0.4||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Symptoms Domain||0.4|-1.0|0.4009
74052461|NCT01241318|147656849|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.88|1.44|||||The chlorhexidine arm is the numerator and dry cord care arm is the denominator in the relative risk calculation. Generalised estimating equation models were used to adjust for cluster randomized design.|||1.44|0.88|
74052462|NCT01241318|147656850|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.86|1.47|||||Generalized estimating equation models adjusting for cluster-randomized design were used.|||1.47|0.86|
74052463|NCT01241318|147656851|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.47|1.13|||||Generalized estimating equation models adjusting for cluster-randomized design were used.|||1.13|0.47|
74052464|NCT02355665|147656855|SUPERIORITY||Estimated Success Rate Ratio|2.0||||0.021|TWO_SIDED|95.0|1.1|3.66||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||3.66|1.10|0.021
74052465|NCT02355665|147656856|SUPERIORITY||Estimated Success Rate Ratio|3.04||||0.004|TWO_SIDED|95.0|1.39|6.68||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.68|1.39|0.004
74052466|NCT02355665|147656857|SUPERIORITY||Estimated Success Rate Ratio|2.87||||0.011|TWO_SIDED|95.0|1.23|6.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.71|1.23|0.011
74052467|NCT02355665|147656858|SUPERIORITY||Estimated Success Rate Ratio|1.66||||0.04|TWO_SIDED|95.0|1.02|2.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||2.71|1.02|0.040
74052468|NCT02355665|147656859|SUPERIORITY||Estimated Success Rate Ratio|2.09||||0.023|TWO_SIDED|95.0|1.09|3.98||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||3.98|1.09|0.023
74052469|NCT02355665|147656860|SUPERIORITY||Estimated Success Rate Ratio|2.91||||0.006|TWO_SIDED|95.0|1.32|6.42||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.42|1.32|0.006
74052470|NCT02355665|147656861|SUPERIORITY||Estimated Success Rate Ratio|2.66||||0.013|TWO_SIDED|95.0|1.2|5.92||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||5.92|1.20|0.013
74052471|NCT02355665|147656862|SUPERIORITY||Estimated Mean Difference|-0.02||||0.847|TWO_SIDED|95.0|-0.64|0.6||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.60|-0.64|0.847
74052472|NCT02355665|147656863|SUPERIORITY||Estimated Mean Difference|-0.1||||0.861|TWO_SIDED|95.0|-0.62|0.42||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.42|-0.62|0.861
74052473|NCT02355665|147656864|SUPERIORITY||Estimated Mean Difference|-0.19||||0.266|TWO_SIDED|95.0|-0.61|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.24|-0.61|0.266
74052474|NCT02355665|147656865|SUPERIORITY||Estimated Mean Difference|0.09||||0.487|TWO_SIDED|95.0|-0.38|0.55||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.55|-0.38|0.487
74099605|NCT03301623|147748417|SUPERIORITY||Odds Ratio (OR)|1.34||||0.26|TWO_SIDED|95.0|0.76|2.34|||Regression, Logistic|We employed robust standard errors clustered at the participant level. Time was controlled for using a fixed effect.|The interaction term describes the effect of PEAT in the post period.|PHQ-9 was categorized by assigning scores of 0, 1, 2, and 3 to the response categories (not at all: several days, more than half the days, nearly every day, respectively) and then summing. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. The analysis was conducted as a multilevel ordered logistic regression.||2.34|.76|.260
74099606|NCT02092467|147748418|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate Cox proportional hazard model with treatment \[All Tofacitinib (ie, tofacitinib 5 mg BID and tofacitinib 10 mg BID combined) and TNFi\] as covariate.|Hazard Ratio (HR)|1.48|||||TWO_SIDED|95.0|1.04|2.09|||||Primary comparison. Non-inferiority was to be claimed between All Tofacitinib and TNFi if the upper limit of the 95% CI for HR was \< 1.8 (non-inferiority criterion).|All Tofacitinib versus TNFi||2.09|1.04|
74052475|NCT02355665|147656866|SUPERIORITY||Estimated Mean Difference|-0.11||||0.433|TWO_SIDED|95.0|-0.65|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.43|-0.65|0.433
74099607|NCT02092467|147748418|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.43|||||Secondary comparison. Non-inferiority was to be claimed between tofacitinib 10 mg BID and tofacitinib 5 mg BID if the upper limit of the 95% CI for HR was \< 2.0 (non-inferiority criterion).|Tofacitinib 10 mg BID versus Tofacitinib 5 mg BID||1.43|0.70|
74099608|NCT02092467|147748418|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|1.0|2.18|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 5 mg BID versus TNFi||2.18|1.00|
74052476|NCT02355665|147656867|SUPERIORITY||Estimated Mean Difference|-0.58||||0.022|TWO_SIDED|95.0|-1.15|-0.01||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||-0.01|-1.15|0.022
74052477|NCT02355665|147656868|SUPERIORITY||Estimated Mean Difference|0.0||||0.665|TWO_SIDED|95.0|-0.5|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.49|-0.50|0.665
74052478|NCT02355665|147656869|SUPERIORITY||Estimated Mean Difference|-0.1||||0.3|TWO_SIDED|95.0|-0.51|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.31|-0.51|0.300
74052479|NCT02355665|147656870|SUPERIORITY||Estimated Mean Difference|-0.17||||0.754|TWO_SIDED|95.0|-0.78|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.43|-0.78|0.754
74052480|NCT02355665|147656871|SUPERIORITY||Estimated Mean Difference|-0.41||||0.116|TWO_SIDED|95.0|-0.89|0.08||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.08|-0.89|0.116
74052481|NCT02355665|147656872|SUPERIORITY||Estimated Mean Difference|-0.14||||0.392|TWO_SIDED|95.0|-0.47|0.2||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.20|-0.47|0.392
74052482|NCT02355665|147656873|SUPERIORITY||Estimated Mean Difference|-0.23||||0.179|TWO_SIDED|95.0|-0.59|0.13||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.13|-0.59|0.179
74052483|NCT02355665|147656874|SUPERIORITY||Estimated Mean Difference|0.01||||0.925|TWO_SIDED|95.0|-0.44|0.47||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.47|-0.44|0.925
74052484|NCT02355665|147656875|SUPERIORITY||Estimated Mean Difference|-0.21||||0.325|TWO_SIDED|95.0|-0.66|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.24|-0.66|0.325
74052485|NCT02355665|147656876|SUPERIORITY||Estimated Mean Difference|0.13||||0.891|TWO_SIDED|95.0|-0.24|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.51|-0.24|0.891
74099609|NCT02092467|147748418|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.48|||||TWO_SIDED|95.0|1.0|2.19|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 10 mg BID versus TNFi||2.19|1.00|
74099610|NCT02092467|147748419|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate Cox proportional hazard model with treatment \[All Tofacitinib (ie, tofacitinib 5 mg BID and tofacitinib 10 mg BID combined) and TNFi\] as covariate.|Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.91|1.94|||||Primary comparison. Non-inferiority was to be claimed between All Tofacitinib and TNFi if the upper limit of the 95% CI for HR was \< 1.8 (non-inferiority criterion).|All Tofacitinib versus TNFi||1.94|0.91|
74099611|NCT02092467|147748419|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.77|1.71|||||Secondary Comparison. Non-inferiority was to be claimed between tofacitinib 10 mg BID and tofacitinib 5 mg BID if the upper limit of the 95% CI for HR was \<2.0 (non-inferiority criterion).|Tofacitinib 10 mg BID versus Tofacitinib 5 mg BID||1.71|0.77|
74099612|NCT02092467|147748419|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.81|1.91|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 5 mg BID versus TNFi||1.91|0.81|
74099613|NCT02092467|147748419|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.94|2.18|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 10 mg BID versus TNFi||2.18|0.94|
74099614|NCT04400682|147748469|EQUIVALENCE|0.80-1.25 margins for equivalence|Mean ratio|1.015||||0|TWO_SIDED|90.0|0.9897|1.041|||ANOVA||||Ln(AUClast) : 0.989- 1.0410|1.0410|0.9897|0.0000
74099615|NCT04400682|147748470|EQUIVALENCE|0.80 - 1.25 equivalence margin is required.|Mean ratio|1.0361||||0.0033|TWO_SIDED|90.0|0.9294|1.1551|||ANOVA||||Ln(Cmax) : 0.9294 - 1.1551|1.1551|0.9294|0.0033
74099616|NCT04400682|147748471|EQUIVALENCE|0.80 - 1.25 equivalence margin is not required.|Mean ratio|1.0108||||0|TWO_SIDED|90.0|0.9856|1.0366|||ANOVA||||Ln(Cmax) : 0.9856 - 1.0366|1.0366|0.9856|0.0000
74052486|NCT02355665|147656877|SUPERIORITY||Estimated Mean Difference|-0.11||||0.721|TWO_SIDED|95.0|-0.48|0.25||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.25|-0.48|0.721
74052487|NCT02355665|147656878|SUPERIORITY||Estimated Mean Difference|-0.03||||0.608|TWO_SIDED|95.0|-0.54|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.49|-0.54|0.608
74052488|NCT02355665|147656879|SUPERIORITY||Estimated Mean Difference|-0.63||||0.014|TWO_SIDED|95.0|-1.16|-0.09||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||-0.09|-1.16|0.014
74052489|NCT02355665|147656880|SUPERIORITY||Estimated Mean Difference|0.04||||0.9|TWO_SIDED|95.0|-0.3|0.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.38|-0.30|0.900
74052490|NCT02355665|147656881|SUPERIORITY||Estimated Mean Difference|-0.06||||0.731|TWO_SIDED|95.0|-0.44|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.31|-0.44|0.731
74052491|NCT02355665|147656882|SUPERIORITY||Estimated Mean Difference|0.04||||0.635|TWO_SIDED|95.0|-0.28|0.36||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.36|-0.28|0.635
74052492|NCT02355665|147656883|SUPERIORITY||Estimated Mean Difference|-0.05||||0.273|TWO_SIDED|95.0|-0.42|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.32|-0.42|0.273
74052493|NCT02355665|147656884|SUPERIORITY||Estimated Mean Difference|-0.06||||0.879|TWO_SIDED|95.0|-0.4|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.28|-0.40|0.879
74052494|NCT02355665|147656885|SUPERIORITY||Estimated Mean Difference|0.02||||0.823|TWO_SIDED|95.0|-0.28|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.32|-0.28|0.823
74052495|NCT02355665|147656886|SUPERIORITY||Estimated Mean Difference|0.0||||0.804|TWO_SIDED|95.0|-0.4|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.40|-0.40|0.804
74052496|NCT02355665|147656887|SUPERIORITY||Estimated Mean Difference|0.13||||0.438|TWO_SIDED|95.0|-0.3|0.57||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.57|-0.30|0.438
74052497|NCT02355665|147656888|SUPERIORITY||Estimated Mean Difference|-0.08||||0.517|TWO_SIDED|95.0|-0.44|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.28|-0.44|0.517
74052498|NCT02355665|147656889|SUPERIORITY||Estimated Mean Difference|-0.42||||0.027|TWO_SIDED|95.0|-0.77|-0.06||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||-0.06|-0.77|0.027
74052499|NCT02355665|147656890|SUPERIORITY||Estimated Mean Difference|-0.3||||0.105|TWO_SIDED|95.0|-0.93|0.33||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.33|-0.93|0.105
74052500|NCT02355665|147656891|SUPERIORITY||Estimated Mean Difference|-0.04||||0.604|TWO_SIDED|95.0|-0.6|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.51|-0.60|0.604
74052501|NCT02355665|147656892|SUPERIORITY||Estimated Mean Difference|-0.35||||0.194|TWO_SIDED|95.0|-0.93|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.24|-0.93|0.194
74052502|NCT02355665|147656893|SUPERIORITY||Estimated Mean Difference|-0.11||||0.502|TWO_SIDED|95.0|-0.62|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.40|-0.62|0.502
74052503|NCT02355665|147656894|SUPERIORITY||Estimated Mean Difference|-0.56||||0.483|TWO_SIDED|95.0|-2.84|1.73||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||1.73|-2.84|0.483
74052504|NCT02355665|147656895|SUPERIORITY||Estimated Mean Difference|-1.79||||0.102|TWO_SIDED|95.0|-4.24|0.67||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||0.67|-4.24|0.102
74052505|NCT02355665|147656896|SUPERIORITY||Estimated Mean Difference|-0.45||||0.532|TWO_SIDED|95.0|-2.27|1.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||1.38|-2.27|0.532
74052506|NCT02355665|147656897|SUPERIORITY||Estimated Mean Difference|-1.01||||0.354|TWO_SIDED|95.0|-2.93|0.91||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||0.91|-2.93|0.354
74052507|NCT02355665|147657066|SUPERIORITY||Least Squares Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|1.679||0.558|TWO_SIDED|95.0|-2.42|4.41||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||4.41|-2.42|0.558
74052508|NCT02355665|147657067|SUPERIORITY||Least Squares Mean Difference|3.04|STANDARD_ERROR_OF_MEAN|3.409||0.383|TWO_SIDED|95.0|-4.03|10.11||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||10.11|-4.03|0.383
74052509|NCT02355665|147657068|SUPERIORITY||Least Squares Mean Difference|7.13|STANDARD_ERROR_OF_MEAN|4.573||0.138|TWO_SIDED|95.0|-2.56|16.83||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||16.83|-2.56|0.138
74052510|NCT01454531|147657093|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Paired values|t-test, 2 sided|||The null hypothesis is no changes in IgE-blocking factor values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in IgE-blocking factor values||||<0.001
74052511|NCT01454531|147657094|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Paired samples|t-test, 2 sided|||The null hypothesis is no changes in Phleum specific IgG4 values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in Phleum specific IgG4 values||||<0.001
74052512|NCT01454531|147657095|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Parallel Line Assay|||Parallel Line Assay is based on the construction of two dose-response regression lines obtained plotting the allergen concentration used to prick test the subjects against the wheal size obtained. ANOVA allows to check for regression, linearity and parallelism. A common slope and y-intercepts are calculated. The CTI is the exponentiation of the difference between y-intercepts divided by the common slope. (Finney D.J., Statistical Method in Biological Assay, 1978).||||<0.01
74052513|NCT00440232|147657128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.969||||0.172|TWO_SIDED|95.0|0.74|5.235|||Chi-squared|||||5.235|0.74|0.172
74052514|NCT00440232|147657129|SUPERIORITY_OR_OTHER||log rank chi square|1.247||||0.264||95.0|||||Log Rank|df=1||||||0.264
74052515|NCT01277666|147657135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.546|TWO_SIDED|95.0|-6.1|11.0|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg once daily||11.0|-6.1|0.546
74052516|NCT01277666|147657135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.648|TWO_SIDED|95.0|-6.5|10.7|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg twice daily||10.7|-6.5|0.648
74052517|NCT01277666|147657136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.592|TWO_SIDED|95.0|-8.8|4.8|||Mantel Haenszel|||||4.8|-8.8|0.592
74099617|NCT02293863|147748475|OTHER||Hazard Ratio (HR)|1.08||||0.605|TWO_SIDED|80.0|0.83|1.4|||Wilcoxon (Mann-Whitney)|||||1.40|0.83|0.6050
74099618|NCT02293863|147748475|OTHER||Hazard Ratio (HR)|1.13||||0.2028|TWO_SIDED|80.0|0.85|1.51|||Wilcoxon (Mann-Whitney)|||||1.51|0.85|0.2028
74099619|NCT02293863|147748477|OTHER||Difference in event rates|10.19||||0.1905|TWO_SIDED|80.0|-0.15|20.52|||Cochran-Mantel-Haenszel|||||20.52|-0.15|0.1905
74099620|NCT02293863|147748477|OTHER||Difference in event rates|7.91||||0.3168|TWO_SIDED|80.0|-2.64|18.47|||Cochran-Mantel-Haenszel|||||18.47|-2.64|0.3168
74099621|NCT02293863|147748478|OTHER||Difference in event rates|-7.92||||0.6043|TWO_SIDED|80.0|-27.5|11.66|||Cochran-Mantel-Haenszel|||||11.66|-27.50|0.6043
74099622|NCT02293863|147748478|OTHER||Difference in event rates|-14.58||||0.3865|TWO_SIDED|80.0|-36.13|6.97|||Cochran-Mantel-Haenszel|||||6.97|-36.13|0.3865
74099623|NCT02293863|147748479|OTHER||Difference in event rates|1.99||||0.5379|TWO_SIDED|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel|||Day 14||9.56|-5.57|0.5379
74099624|NCT02293863|147748479|OTHER||Difference in event rates|4.97||||0.2189|TWO_SIDED|80.0|-3.12|13.05|||Cochran-Mantel-Haenszel|||Day 14||13.05|-3.12|0.2189
74052518|NCT01277666|147657136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.475|TWO_SIDED|95.0|-9.2|4.4|||Mantel Haenszel|||||4.4|-9.2|0.475
74019354|NCT02058147|147590892|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.891|-0.91||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline body weight value-by-visit interaction as a covariate.||-0.91|-1.891|<0.0001
74052519|NCT01277666|147657137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.415|TWO_SIDED|95.0|-4.4|10.3|||Mantel Haenszel|||||10.3|-4.4|0.415
74052520|NCT01277666|147657137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.354|TWO_SIDED|95.0|-3.9|10.9|||Mantel Haenszel|||||10.9|-3.9|0.354
74052521|NCT01277666|147657138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-5.2|5.2|||Mantel Haenszel|||||5.2|-5.2|0.985
74052522|NCT01277666|147657138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.709|TWO_SIDED|95.0|-6.1|4.1|||Mantel Haenszel|||||4.1|-6.1|0.709
74052523|NCT01277666|147657139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.633|TWO_SIDED|95.0|-6.5|10.4|||Mantel Haenszel|||||10.4|-6.5|0.633
74052524|NCT01277666|147657139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.889|TWO_SIDED|95.0|-7.8|9.0|||Mantel Haenszel|||||9.0|-7.8|0.889
74052525|NCT01277666|147657140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.541|TWO_SIDED|95.0|-8.1|4.2|||Mantel Haenszel|||||4.2|-8.1|0.541
74019355|NCT02058147|147590893|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.144|<|0.0001|TWO_SIDED|95.0|-2.246|-1.682||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline FPG value-by-visit interaction as a covariate.||-1.682|-2.246|<0.0001
73888142|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|50.9|||<|0.0001|TWO_SIDED|95.0|34.2|67.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.5|34.2|<0.0001
74019356|NCT02058147|147590894|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001|TWO_SIDED|95.0|-1.645|-1.158||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction as a covariate.||-1.158|-1.645|<0.0001
74019357|NCT02058147|147590894|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.892|-0.495||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction, as a covariate.||-0.495|-0.892|<0.0001
74019358|NCT02058147|147590895|SUPERIORITY_OR_OTHER||Difference in percentage|18.08|||<|0.0001|TWO_SIDED|95.0|12.15|24.01||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8%, ≥8%) and randomization strata of second OAD use at screening.||24.01|12.15|<0.0001
74019359|NCT02058147|147590896|SUPERIORITY_OR_OTHER||Difference in percentage|12.98|||<|0.0001|TWO_SIDED|95.0|7.5|18.45||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening.||18.45|7.5|< 0.0001
74019360|NCT02058147|147590897|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.99||0.4857|TWO_SIDED|95.0|-2.632|1.252||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects.||1.252|-2.632|0.4857
74019361|NCT00820573|147590908|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"A general unstructured variance-covariance matrix (ANOVA) was applied for measurements at different periods. Between-group comparisons after 6 wks of treatment were assessed using the ANOVA model at alpha=0.05 (two-sided).~16 subjects provide \~90% power to detect difference in EGP of 0.28 mg/kg.min (95% CI = 0.17 mg/kg.min)."||||<0.05
74019362|NCT00820573|147590909|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||multivariate analysis was performed to compare results amongst all four groups||||<0.05
74019363|NCT00820573|147590910|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||ANOVA||||0.05
74019364|NCT00820573|147590911|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
74019365|NCT03604445|147590912|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
74052526|NCT01277666|147657140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.43|TWO_SIDED|95.0|-8.5|3.7|||Mantel Haenszel|||||3.7|-8.5|0.430
74052527|NCT01277666|147657141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13|STANDARD_ERROR_OF_MEAN|2.426||0.642|TWO_SIDED|95.0|-5.89|3.64||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8||3.64|-5.89|0.642
74052528|NCT01277666|147657141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|2.652||0.898|TWO_SIDED|95.0|-5.55|4.87||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12||4.87|-5.55|0.898
74052529|NCT01277666|147657141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.37|STANDARD_ERROR_OF_MEAN|2.467||0.173|TWO_SIDED|95.0|-1.48|8.21||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8||8.21|-1.48|0.173
74052530|NCT01277666|147657141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.85|STANDARD_ERROR_OF_MEAN|2.697||0.493|TWO_SIDED|95.0|-3.45|7.15||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12||7.15|-3.45|0.493
74052531|NCT01032265|147657160|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27||95.0|||||Mixed Models Analysis|||analysis between groups||||0.27
74052532|NCT01032265|147657161|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||95.0|||||Mixed Models Analysis|||analysis between groups||||0.52
74052533|NCT01032265|147657162|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Mixed Models Analysis|||analysis between groups||||0.30
74052534|NCT01032265|147657163|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.02
74052535|NCT01032265|147657164|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||<0.001
74052536|NCT01032265|147657165|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23||95.0|||||negative binomial regression|||analysis between groups||||0.23
74052537|NCT01032265|147657166|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.01
74052538|NCT02728804|147657168|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.65|TWO_SIDED|95.0|0.66|1.29|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.29|0.66|0.65
74052539|NCT02728804|147657169|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7|TWO_SIDED|95.0|0.79|1.43|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.43|0.79|0.70
74052540|NCT02728804|147657170|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.87|TWO_SIDED|95.0|0.73|1.31|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.31|0.73|0.87
74052541|NCT02728804|147657171|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.92|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||0.92|0.48|0.01
74052542|NCT02728804|147657172|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.1|TWO_SIDED|95.0|0.95|1.87|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.87|0.95|0.10
74052543|NCT02728804|147657172|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.002|TWO_SIDED|95.0|1.28|2.89|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||2.89|1.28|0.002
74052544|NCT02514889|147657191|SUPERIORITY||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|2.05||0.3|TWO_SIDED|95.0|-6.12|1.91||a priori threshold is p = .017, so that experiment-wide critical alpha would be p = .05.|Mixed Models Analysis|Covariates: sex, age, ethnicity, marital status and educational attainment|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).|||1.91|-6.12|0.30
74052545|NCT02514889|147657192|EQUIVALENCE|p-value \>0.20 would be considered equivalent.|Mean Difference (Final Values)|2.59|STANDARD_ERROR_OF_MEAN|1.39||0.06|TWO_SIDED|95.0|-0.1342|5.3228|||Mixed Models Analysis|Covariates included age, sex, ethnicity, educational attainment and marital status||||5.3228|-0.1342|0.06
74052546|NCT02514889|147657193|SUPERIORITY||Mean Difference (Net)|-1.37|STANDARD_ERROR_OF_MEAN|2.55||0.504|TWO_SIDED|95.0|-6.37|3.63|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).|||3.63|-6.37|0.504
74099625|NCT02293863|147748479|OTHER||Difference in event rates|2.14||||0.6594|TWO_SIDED|80.0|-6.04|10.31|||Cochran-Mantel-Haenszel|||Day 30||10.31|-6.04|0.6594
74099626|NCT02293863|147748479|OTHER||Difference in event rates|3.54||||0.5013|TWO_SIDED|80.0|-5.24|12.31|||Cochran-Mantel-Haenszel|||Day 30||12.31|-5.24|0.5013
74099627|NCT02293863|147748479|OTHER||Difference in event rates|2.21||||0.6849|TWO_SIDED|80.0|-6.28|10.69|||Cochran-Mantel-Haenszel|||Day 60||10.69|-6.28|0.6849
74099628|NCT02293863|147748479|OTHER||Difference in event rates|1.68||||0.7633|TWO_SIDED|80.0|-7.38|10.74|||Cochran-Mantel-Haenszel|||Day 60||10.74|-7.38|0.7633
74099629|NCT02293863|147748480|OTHER||Mean Difference (Final Values)|-3.73||||0.2407|TWO_SIDED|80.0|-6.41|-1.06|||ANOVA|||||-1.06|-6.41|0.2407
74099630|NCT02293863|147748480|OTHER||Mean Difference (Final Values)|-0.7||||0.8339|TWO_SIDED|80.0|-3.49|2.1|||ANOVA|||||2.10|-3.49|0.8339
74099631|NCT02293863|147748481|OTHER||Mean Difference (Final Values)|-0.33||||0.279|TWO_SIDED|80.0|-0.6|-0.07|||ANOVA|||||-0.07|-0.60|0.2790
74099632|NCT02293863|147748481|OTHER||Mean Difference (Final Values)|-0.42||||0.1909|TWO_SIDED|80.0|-0.7|-0.15|||ANOVA|||||-0.15|-0.70|0.1909
74099633|NCT02293863|147748482|OTHER||Hazard Ratio (HR)|1.01||||0.7413|TWO_SIDED|80.0|0.77|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.77|0.7413
74099634|NCT02293863|147748482|OTHER||Hazard Ratio (HR)|1.32||||0.4763|TWO_SIDED|80.0|0.99|1.77|||Wilcoxon (Mann-Whitney)|||||1.77|0.99|0.4763
74099635|NCT02293863|147748483|OTHER||Hazard Ratio (HR)|1.01||||0.8806|TWO_SIDED|80.0|0.78|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.78|0.8806
74099636|NCT02293863|147748483|OTHER||Hazard Ratio (HR)|1.05||||0.5447|TWO_SIDED|80.0|0.8|1.38|||Wilcoxon (Mann-Whitney)|||||1.38|0.80|0.5447
74099637|NCT02293863|147748484|OTHER||Hazard Ratio (HR)|0.7||||0.4171|TWO_SIDED|80.0|0.47|1.03|||Wilcoxon (Mann-Whitney)|||||1.03|0.47|0.4171
74099638|NCT02293863|147748484|OTHER||Hazard Ratio (HR)|0.9||||0.8322|TWO_SIDED|80.0|0.61|1.34|||Wilcoxon (Mann-Whitney)|||||1.34|0.61|0.8322
74099639|NCT02293863|147748485|OTHER||Difference in event rates|-1.42||||0.824|TWO_SIDED|80.0|-10.61|7.76|||Cochran-Mantel-Haenszel|||||7.76|-10.61|0.8240
74099640|NCT02293863|147748485|OTHER||Difference in event rates|-1.6||||0.8111|TWO_SIDED|80.0|-11.48|8.28|||Cochran-Mantel-Haenszel|||||8.28|-11.48|0.8111
74052547|NCT02514889|147657194|SUPERIORITY|Difference in differences|Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|2.35||0.3|TWO_SIDED|95.0|-6.47|2.74|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment, marital status|The difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||2.74|-6.47|0.30
74052548|NCT02514889|147657195|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.99||0.64|TWO_SIDED|95.0|-1.47|2.39|||Mixed Models Analysis||The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||2.39|-1.47|0.640
74052549|NCT02514889|147657196|EQUIVALENCE|For the comparison conditions to be equivalent, as predicted, the critical alpha was set at P \> 0.20.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.135||0.747|TWO_SIDED|95.0|-0.31|0.22|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||0.22|-.31|0.747
74052550|NCT02514889|147657197|EQUIVALENCE|For the comparison conditions to be judged equivalent, as predicted, the critical p-value was set to P \>.20|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.51||0.776|TWO_SIDED|95.0|-0.85|1.14|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||1.14|-0.85|0.776
74052551|NCT02475564|147657198|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mann-Whitney test|||A sample size of at least 21 patients per arm would be necessary to have a 90% chance of detecting, as significant at the 1% level, a difference of 3 points in a scale of 10 points, between both groups as the primary outcome, after 42 days of treatment.||||0.7
74052552|NCT02475564|147657199|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mann-Whitney test|||||||0.1
74052553|NCT02475564|147657200|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mann-Whitney test|||||||0.8
74052554|NCT02705755|147657214|SUPERIORITY||Least Squares Mean Difference|-4.4||||0.0399|TWO_SIDED|95.0|-8.57|-0.23||P-values were reported without multiplicity adjustment.|Repeated-measures Mixed-effect Model|||Least squares mean differences were calculated based on a repeated-measures mixed-effect model with change from baseline at different time points as the dependent variable, the treatment group (TD-9855 or placebo), time point, baseline and the interaction between the treatment group and time point as fixed factors. A compound symmetry was used as the variance-covariance structure.||-0.23|-8.57|0.0399
73881545|NCT03192176|147297634|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|4.5||0.737|TWO_SIDED|95.0|-10.38|7.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||7.35|-10.38|0.7370
74052555|NCT02551874|147657222|NON_INFERIORITY|Noninferiority was defined by upper bound of 95% CI \<0.3%|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.085||0.118|TWO_SIDED|95.0|-0.3|0.03||Superiority|Mixed Models Analysis|Adjusted for treatment, baseline HbA1c, randomization stratification factor, visit, treatment-by-visit, and baseline HbA1c-by-visit.||||0.03|-0.30|0.118
74052556|NCT02551874|147657223|SUPERIORITY||Mean Difference (Final Values)|-3.64|STANDARD_ERROR_OF_MEAN|0.282|<|0.001|TWO_SIDED|95.0|-4.2|-3.09|||Mixed Models Analysis|Adjusted for treatment, baseline body weight, randomization stratification factor, visit, treatment-by-visit, and baseline body weight-by-visit.||||-3.09|-4.20|<0.001
74052557|NCT02551874|147657224|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.62|||Regression, Logistic|Adjusted for baseline HbA1c and randomization stratification factor (background medication of metformin with or without SU).||||0.62|0.30|<0.001
74052558|NCT02551874|147657225|SUPERIORITY||Odds Ratio (OR)|1.8||||0.008|TWO_SIDED|95.0|1.16|2.67|||Regression, Logistic|||||2.67|1.16|0.008
74052559|NCT02551874|147657226|NON_INFERIORITY|Noninferiority was defined by lower bound of 95% CI \>-10%.|Adjusted Percent Difference|-0.4|||||TWO_SIDED|95.0|-7.42|6.54||||||||6.54|-7.42|
74052560|NCT02551874|147657227|NON_INFERIORITY|Noninferiority was defined by upper bound of 95% CI \<12 mg/dL.|Mean Difference (Final Values)|-19.99|STANDARD_ERROR_OF_MEAN|3.55|<|0.0001|TWO_SIDED|95.0|-26.98|-13.0|||Mixed Models Analysis|Adjusted for treatment, baseline measurement, randomization stratification factor, visit, treatment-by-visit, and baseline-by-visit.||||-13.00|-26.98|<0.0001
74052561|NCT03479203|147657257|OTHER|T-Test followed by Bonferroni post-hoc analysis.|Mean Difference (Final Values)|1.96|STANDARD_DEVIATION|1.5||0.05|TWO_SIDED|95.0|1.0|6.0|||t-test, 2 sided|||"Blood assessed for C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM), the high mobility group box-1 (HMGB1), the NLRP3 inflammasome, and nitrates (NOx for nitric oxide) pre- and post-vaping. CRP, sICAM HMGB1 and NLRP3 is in ng/ml blood and NOx is in nanomol/ml. These numbers were weighted to obtain an inflammation index in blood. This index represents the fold increase over pre-vaping values."||6|1|0.05
74099641|NCT02293863|147748486|OTHER||Difference in event rates|2.42||||0.7219|TWO_SIDED|80.0|-6.96|11.8|||Cochran-Mantel-Haenszel|||||11.80|-6.96|0.7219
74099642|NCT02293863|147748486|OTHER||Difference in event rates|0.67||||0.9225|TWO_SIDED|80.0|-9.29|10.64|||Cochran-Mantel-Haenszel|||||10.64|-9.29|0.9225
74099643|NCT02293863|147748487|OTHER||Difference in event rates|1.99||||0.5379|TWO_SIDED|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel|||||9.56|-5.57|0.5379
74099644|NCT02293863|147748487|OTHER||Difference in event rates|-1.85||||0.3667|TWO_SIDED|80.0|-9.88|6.18|||Cochran-Mantel-Haenszel|||||6.18|-9.88|0.3667
74099645|NCT02293863|147748488|OTHER||Hazard Ratio (HR)|0.66||||0.7827|TWO_SIDED|80.0|0.41|1.07|||Wilcoxon (Mann-Whitney)|||||1.07|0.41|0.7827
74099646|NCT02293863|147748488|OTHER||Hazard Ratio (HR)|0.58||||0.2522|TWO_SIDED|80.0|0.36|0.96|||Wilcoxon (Mann-Whitney)|||||0.96|0.36|0.2522
73881546|NCT03192176|147297634|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|4.46||0.5269|TWO_SIDED|95.0|-11.62|5.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||5.96|-11.62|0.5269
74052562|NCT03419741|147657265|OTHER|We plan to enroll 20 participants within one year. Eleven participants were enrolled. 11/20 = 55% completed the number of enrollment.|%|11.0|||||TWO_SIDED||||||percentage|||||||
74099647|NCT00602641|147748705|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Presuming the control over the experimental arm (MPT-T/mPR-R), the inferiority of mPR-R was defined as a PFS treatment hazard ratio (HR) of less than or equal to 0.82 corresponding to median PFS on the mPR-R arm of 20.5 months (mos) vs. 25 mos on the MPT-T arm. With 304 patients and 221 PFS events, there was 86% power to detect non-inferiority of mPR-R at a 1-sided 0.05 significance level assuming a superiority alternative of HR=1.2 corresponding to median PFS on the mPR-R arm of 30 mos.|Hazard Ratio (HR)|0.84|||||TWO_SIDED|90.0|0.67|1.045|||||Analysis based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y). The fact that the lower-bound was less than 0.82 and the upper bound was above 1.0 indicates that results were inconclusive for the primary objective.|Since mPR-R was expected to be considerably less toxic and to confer slightly longer PFS, a non-inferiority design with superiority alternative was used.||1.045|0.67|
74099648|NCT00602641|147748706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.476|TWO_SIDED||||||Log Rank|Analysis was based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y).||||||0.476
73888143|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.3905|TWO_SIDED|95.0|-9.4|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.0|-9.4|0.3905
74052563|NCT01091116|147657308|SUPERIORITY_OR_OTHER|||||||0.5263||95.0|||||ANCOVA|||Tests of Fixed Effects for the primary efficacy variable including baseline treatment and visit (from Visit 3 to Visit 5) as covariates||||0.5263
74052564|NCT02194699|147657322|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.84||||0.4656|TWO_SIDED|95.0|0.53|1.34|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.34|0.53|0.4656
74099649|NCT00602641|147748707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204|TWO_SIDED||||||Fisher Exact|||||||0.204
74099650|NCT00602641|147748708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
74099651|NCT00826007|147748723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.18|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|0.09|0.18|||Regression, Logistic|||||.18|.09|<0.001
74099652|NCT00261443|147748789|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.544||||0.014|TWO_SIDED|95.0|0.332|0.893||Stratified Log-rank Test, controlling for type of mood stabilizer and type of mood episode|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||0.893|0.332|0.014
74099653|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.01||||0.911|TWO_SIDED|95.0|-0.16|0.15||ANOVA model, controlling for treatment, mood stabilizer, and index mood episode used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value used for mean change from baseline.|ANOVA/ANCOVA|Means, difference in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.15|-0.16|0.911
74099654|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.557|TWO_SIDED|95.0|-0.09|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.18|-0.09|0.557
74099655|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.04||||0.596|TWO_SIDED|95.0|-0.18|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.10|-0.18|0.596
74099656|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.05||||0.522|TWO_SIDED|95.0|-0.22|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.11|-0.22|0.522
73881547|NCT03192176|147297634|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|4.58||0.3937|TWO_SIDED|95.0|-12.93|5.11||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||5.11|-12.93|0.3937
74052565|NCT02194699|147657322|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.13||||0.4126|TWO_SIDED|95.0|0.85|1.5|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.50|0.85|0.4126
74052566|NCT02194699|147657322|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|15.83||||0.4656|TWO_SIDED|95.0|-33.71|47.01|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate reduction): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||47.01|-33.71|0.4656
73888144|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|28.6||||0.0009|TWO_SIDED|95.0|11.9|45.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|11.9|0.0009
74052567|NCT02194699|147657322|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.03||||0.8027|TWO_SIDED|95.0|0.81|1.31|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): FAS population; Tralo 300 mg Q2W vs placebo.||1.31|0.81|0.8027
74052568|NCT02194699|147657322|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|-3.14||||0.8027|TWO_SIDED|95.0|-31.46|19.08|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): FAS population; Tralo 300 mg Q2W vs placebo.||19.08|-31.46|0.8027
74052569|NCT02194699|147657323|SUPERIORITY||Least square (LS) Mean difference|1.86||||0.6033|TWO_SIDED|95.0|-5.16|8.88|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||8.88|-5.16|0.6033
74052570|NCT02194699|147657323|SUPERIORITY||LS Mean difference|3.37||||0.1276|TWO_SIDED|95.0|-0.97|7.7|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||7.70|-0.97|0.1276
74052571|NCT02194699|147657323|SUPERIORITY||LS Mean difference|2.95||||0.1164|TWO_SIDED|95.0|-0.73|6.62|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment||6.62|-0.73|0.1164
74052572|NCT02194699|147657324|SUPERIORITY||LS Mean difference|-0.2||||0.1456|TWO_SIDED|95.0|-0.47|0.07|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.07|-0.47|0.1456
74052573|NCT02194699|147657324|SUPERIORITY||LS Mean difference|0.04||||0.6548|TWO_SIDED|95.0|-0.13|0.2|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.20|-0.13|0.6548
74019366|NCT03604445|147590912|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
74019367|NCT03604445|147590912|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
74019368|NCT03604445|147590912|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
74019369|NCT03604445|147590912|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
74019370|NCT03604445|147590912|OTHER||Probability of DLT rate in [0.16, 0.33)|0.003|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
74019371|NCT03604445|147590912|OTHER||Probability of DLT rate in [0.16, 0.33)|0.035|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.001|||
74019372|NCT03604445|147590912|OTHER||Probability of DLT rate in [0.16, 0.33)|0.176|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.018|||
74019373|NCT03604445|147590912|OTHER||Probability of DLT rate in [0.16, 0.33)|0.129|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.83|||
74019374|NCT01014585|147590921|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44||||0.0004|TWO_SIDED|95.0|0.27|0.71|||Log Rank|||||0.71|0.27|0.0004
74019375|NCT01014585|147590921|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|18.0||||||95.0||||||||||||
74019376|NCT01014585|147590921|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|45.0||||||95.0||||||||||||
74019377|NCT01014585|147590922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.0002|TWO_SIDED|95.0|0.2|0.63|||Log Rank|||||0.63|0.20|0.0002
74019378|NCT01014585|147590922|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|22.0||||||95.0||||||||||||
74019379|NCT01014585|147590923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.4104|TWO_SIDED|95.0|0.46|1.38|||Log Rank|||||1.38|0.46|0.4104
74019380|NCT01014585|147590923|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|18.0||||||95.0||||||||||||
74019381|NCT01014585|147590923|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|30.0||||||95.0||||||||||||
74019382|NCT00773279|147590924|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95 % Confidence Interval (CI) for the treatment difference, PDS290 minus FlexPen, in HbA1c after 12 weeks of treatment. PDS290 was to be declared non-inferior to FlexPen® if the upper limit of that CI would be less than the non-inferiority margin 0.40 % (absolute)."|Mean Difference (Final Values)|-0.047|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.127|0.032|||Linear mixed effect model|Linear mixed effect model with period and delivery systems as fixed effects, and subject as a random effect.||The null hypothesis is that PDS290 be not non-inferior to FlexPen® with respect to HbA1c after 12 weeks of treatment; non-inferiority margin is 0.4 % (absolute).||0.032|-0.127|
74019383|NCT00508391|147590962|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis utilized an objective performance criteria of 63% with a clinically significant difference of 12%. For the non-inferiority hypothesis, the one-sided Type I error was set to 0.05 and the statistical power was set to 80%.|Objective Performance Criteria|63.0|||||ONE_SIDED|95.0|54.8||||Non-inferiority comparison|||"Efficacy was assessed in a non-inferiority, responder classification design where the proportion of total subjects classified as not worsened after changing from optimized to simultaneous biventricular pacing was compared to an objective performance criteria.~An effect of gender analysis was performed on the primary efficacy endpoint to compare the proportion of males and females classified as not worsened after changing from optimized to simultaneous biventricular pacing."|||54.8|
74019384|NCT00508391|147590963|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis has a one-sided Type I error of 0.05 with an 80% statistical power.|Objective Performance Criteria|100.0|||||ONE_SIDED|95.0|97.6||||Non-inferiority comparison|||Safety will be evaluated in a non-inferiority format. The null hypothesis is the percent of subjects that did not experience an adverse event with an active interventricular delay feature at two months is inferior to 90% with a clinically significant difference of 10%|||97.6|
74099657|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.13||||0.142|TWO_SIDED|95.0|-0.3|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.04|-0.30|0.142
74019385|NCT00954109|147590991|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
74019386|NCT00954109|147590992|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
74019387|NCT04660643|147591011|SUPERIORITY||LS Mean difference|-21.4|||<|0.001|TWO_SIDED|95.0|-22.9|-20.0|||Mixed Models Analysis|||||-20.0|-22.9|<.001
74019388|NCT04660643|147591012|SUPERIORITY||LS Mean difference|-15.9|||<|0.001|TWO_SIDED|95.0|-17.0|-14.9|||Mixed Models Analysis|||||-14.9|-17.0|<.001
74019389|NCT04660643|147591013|SUPERIORITY||LS Mean difference|-17.6|||<|0.001|TWO_SIDED|95.0|-18.8|-16.4|||Mixed Models Analysis|||||-16.4|-18.8|<.001
74019390|NCT04660643|147591014|SUPERIORITY||LS Mean difference|-12.9|||<|0.001|TWO_SIDED|95.0|-14.1|-11.7|||Mixed Models Analysis|||||-11.7|-14.1|<.001
74019391|NCT04660643|147591015|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-6.8|-6.0|||Mixed Models Analysis|||||-6.0|-6.8|<.001
74019392|NCT04660643|147591016|SUPERIORITY||LS Mean difference|-8.64|||<|0.001|TWO_SIDED|95.0|-10.14|-7.15|||Mixed Models Analysis|||||-7.15|-10.14|<.001
74019393|NCT04660643|147591017|SUPERIORITY||LS Mean difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.38|-0.28|||Mixed Models Analysis|||||-0.28|-0.38|<.001
74019394|NCT04660643|147591018|SUPERIORITY||LS Mean difference|-31.4|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-37.7|-24.4|||Mixed Models Analysis|||||-24.4|-37.7|<.001
74019395|NCT04660643|147591019|SUPERIORITY||LS Mean difference|-5.54|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-7.76|-3.28|||Mixed Models Analysis|||Total Cholesterol||-3.28|-7.76|<.001
74019396|NCT04660643|147591019|SUPERIORITY||LS Mean difference|-6.57|STANDARD_ERROR_OF_MEAN|1.709|<|0.001|TWO_SIDED|95.0|-9.87|-3.15|||Mixed Models Analysis|||LDL Cholesterol||-3.15|-9.87|<.001
74019397|NCT04660643|147591019|SUPERIORITY||LS Mean difference|3.2|STANDARD_ERROR_OF_MEAN|1.33||0.014|TWO_SIDED|95.0|0.6|5.8|||Mixed Models Analysis|||HDL Cholesterol||5.8|0.6|0.014
74019398|NCT04660643|147591019|SUPERIORITY||LS Mean difference|-19.7|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-24.0|-15.1|||Mixed Models Analysis|||VLDL Cholesterol||-15.1|-24.0|<.001
74019399|NCT04660643|147591019|SUPERIORITY||LS Mean difference|-20.6|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-24.9|-16.0|||Mixed Models Analysis|||Triglycerides||-16|-24.9|<.001
74019400|NCT04660643|147591019|SUPERIORITY||LS Mean difference|-10.8|STANDARD_ERROR_OF_MEAN|3.79||0.008|TWO_SIDED|95.0|-17.9|-3.0|||Mixed Models Analysis|||FFA||-3.0|-17.9|0.008
74019401|NCT04660643|147591020|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-8.1|-4.6|||Mixed Models Analysis|||SBP||-4.6|-8.1|<.001
74019402|NCT04660643|147591020|SUPERIORITY||LS Mean difference|-3.6|||<|0.001|TWO_SIDED|95.0|-4.8|-2.4|||Mixed Models Analysis|||DBP||-2.4|-4.8|<.001
74019403|NCT04660643|147591021|SUPERIORITY||LS Mean difference|2.6|||<|0.001|TWO_SIDED|95.0|1.7|3.5|||ANCOVA|||||3.5|1.7|<.001
74019404|NCT04660643|147591022|SUPERIORITY||LS Mean difference|9.4|||<|0.001|TWO_SIDED|95.0|6.8|12.0|||ANCOVA|||||12.0|6.8|<0.001
74019405|NCT04660643|147591023|SUPERIORITY||Odds Ratio (OR)|95.91|||<|0.001|TWO_SIDED|95.0|54.72|168.09|||Regression, Logistic|||||168.09|54.72|<0.001
74019406|NCT04660643|147591024|SUPERIORITY||Odds Ratio (OR)|47.27|||<|0.001|TWO_SIDED|95.0|18.32|121.99|||Regression, Logistic|||≥5% body weight reduction from baseline||121.99|18.32|<0.001
74019407|NCT04660643|147591024|SUPERIORITY||Odds Ratio (OR)|71.51|||<|0.001|TWO_SIDED|95.0|34.46|148.39|||Regression, Logistic|||≥10% body weight reduction from baseline||148.39|34.46|<0.001
74019408|NCT04660643|147591024|SUPERIORITY||Odds Ratio (OR)|79.99|||<|0.001|TWO_SIDED|95.0|42.06|152.14|||Regression, Logistic|||≥15% body weight reduction from baseline||152.14|42.06|<0.001
74019409|NCT04660643|147591024|SUPERIORITY||Odds Ratio (OR)|140.84|||<|0.001|TWO_SIDED|95.0|66.06|300.29|||Regression, Logistic|||≥20% body weight reduction from baseline||300.29|66.06|<0.001
74019410|NCT04660643|147591025|SUPERIORITY||Hazard Ratio (HR)|0.013|||<|0.001|TWO_SIDED|95.0|0.004|0.046|||Log Rank||Unstratified hazard ratio from Cox proportional hazard model with Baseline Weight (kg), Analysis Country, Sex, IWRS MTD at Week 36, Weight at randomization (kg) as covariates.|||0.046|0.004|<.001
74019411|NCT04660643|147591026|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-6.8|-6.0|||Mixed Models Analysis|||||-6.0|-6.8|<.001
74019412|NCT04660643|147591027|SUPERIORITY||LS Mean difference|-17.6|||<|0.001|TWO_SIDED|95.0|-18.8|-16.4|||Mixed Models Analysis|||||-16.4|-18.8|<.001
74019413|NCT04660643|147591028|SUPERIORITY||LS Mean difference|-16.4|||<|0.001|TWO_SIDED|95.0|-17.5|-15.4|||Mixed Models Analysis|||||-15.4|-17.5|<.001
74019414|NCT04660643|147591029|SUPERIORITY||LS Mean difference|-13.6|||<|0.001|TWO_SIDED|95.0|-15.1|-12.2|||Mixed Models Analysis|||||-12.2|-15.1|<.001
74019415|NCT04660643|147591030|SUPERIORITY||LS Mean difference|-8.92|||<|0.001|TWO_SIDED|95.0|-10.4|-7.43|||Mixed Models Analysis|||||-7.43|-10.40|<.001
74019416|NCT04660643|147591031|SUPERIORITY||LS Mean difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.39|-0.29|||Mixed Models Analysis|||||-0.29|-0.39|<.001
74019417|NCT04660643|147591032|SUPERIORITY||LS Mean difference|-34.6|STANDARD_ERROR_OF_MEAN|3.25|<|0.001|TWO_SIDED|95.0|-40.6|-27.9|||Mixed Models Analysis|||||-27.9|-40.6|<.001
74019418|NCT04660643|147591033|SUPERIORITY||LS Mean difference|-7.02|STANDARD_ERROR_OF_MEAN|1.158|<|0.001|TWO_SIDED|95.0|-9.27|-4.72|||Mixed Models Analysis|||Total Cholesterol||-4.72|-9.27|<.001
74019419|NCT04660643|147591033|SUPERIORITY||LS Mean difference|-7.62|STANDARD_ERROR_OF_MEAN|1.707|<|0.001|TWO_SIDED|95.0|-10.91|-4.21|||Mixed Models Analysis|||LDL Cholesterol||-4.21|-10.91|<.001
74019420|NCT04660643|147591033|SUPERIORITY||LS Mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.418||0.064|TWO_SIDED|95.0|-0.14|5.43|||Mixed Models Analysis|||HDL Cholesterol||5.43|-0.14|0.064
74019421|NCT04660643|147591033|SUPERIORITY||LS Mean difference|-20.1|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-24.7|-15.3|||Mixed Models Analysis|||VLDL Cholesterol||-15.3|-24.7|<.001
73881548|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.59||0.846|TWO_SIDED|95.0|-8.15|9.94||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||9.94|-8.15|0.8460
73881549|NCT03192176|147297634|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|4.57||0.5673|TWO_SIDED|95.0|-11.62|6.38||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||6.38|-11.62|0.5673
73881550|NCT03192176|147297634|SUPERIORITY||LSMean difference|4.0|STANDARD_ERROR_OF_MEAN|4.49||0.3791|TWO_SIDED|95.0|-4.88|12.79||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||12.79|-4.88|0.3791
73881551|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.47||0.834|TWO_SIDED|95.0|-7.86|9.73||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||9.73|-7.86|0.8340
74052574|NCT02194699|147657324|SUPERIORITY||LS Mean difference|-0.04||||0.5763|TWO_SIDED|95.0|-0.18|0.1|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in total asthma symptom score at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.10|-0.18|0.5763
74052575|NCT02194699|147657325|SUPERIORITY||LS Mean difference|0.27||||0.0874|TWO_SIDED|95.0|-0.04|0.57|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.57|-0.04|0.0874
74099658|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.16||||0.092|TWO_SIDED|95.0|-0.35|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.03|-0.35|0.092
74099659|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.2||||0.039|TWO_SIDED|95.0|-0.4|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.01|-0.40|0.039
74099660|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.21||||0.05|TWO_SIDED|95.0|-0.43|0.0||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.00|-0.43|0.050
74099661|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.064|TWO_SIDED|95.0|-0.4|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.01|-0.40|0.064
73881552|NCT03192176|147297634|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|4.67||0.9457|TWO_SIDED|95.0|-9.51|8.88||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||8.88|-9.51|0.9457
74019422|NCT04660643|147591033|SUPERIORITY||LS Mean difference|-21.2|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-25.8|-16.4|||Mixed Models Analysis|||Triglycerides||-16.4|-25.8|<.001
74019423|NCT04660643|147591033|SUPERIORITY||LS Mean difference|-11.83|STANDARD_ERROR_OF_MEAN|3.793||0.004|TWO_SIDED|95.0|-18.98|-4.06|||Mixed Models Analysis|||FFA||-4.06|-18.98|0.004
74019424|NCT04660643|147591034|SUPERIORITY||LS Mean difference|-6.9|||<|0.001|TWO_SIDED|95.0|-8.7|-5.1|||Mixed Models Analysis|||SBP||-5.1|-8.7|<.001
74019425|NCT04660643|147591034|SUPERIORITY||LS Mean difference|-3.8|||<|0.001|TWO_SIDED|95.0|-5.1|-2.6|||Mixed Models Analysis|||DBP||-2.6|-5.1|<.001
74019426|NCT04660643|147591035|SUPERIORITY||LS Mean difference|2.7|||<|0.001|TWO_SIDED|95.0|1.7|3.7|||ANCOVA|||||3.7|1.7|<.001
74019427|NCT04660643|147591036|SUPERIORITY||LS Mean difference|9.3|||<|0.001|TWO_SIDED|95.0|6.5|12.0|||ANCOVA|||||12.0|6.5|<.001
74019428|NCT03988907|147591037|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|0.93|1.26||||||||1.26|0.93|
74052576|NCT02194699|147657325|SUPERIORITY||LS Mean difference|-0.01||||0.9083|TWO_SIDED|95.0|-0.2|0.17|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.17|-0.20|0.9083
74052577|NCT02194699|147657325|SUPERIORITY||LS Mean difference|0.06||||0.4506|TWO_SIDED|95.0|-0.1|0.22|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.22|-0.10|0.4506
74052578|NCT02194699|147657326|SUPERIORITY||LS Mean difference|-0.27||||0.04|TWO_SIDED|95.0|-0.53|-0.01|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||-0.01|-0.53|0.0400
74052579|NCT02194699|147657326|SUPERIORITY||LS Mean difference|0.0||||0.9735|TWO_SIDED|95.0|-0.16|0.16|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.16|-0.16|0.9735
74052580|NCT02194699|147657326|SUPERIORITY||LS Mean difference|-0.08||||0.2432|TWO_SIDED|95.0|-0.21|0.05|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for ACQ-6 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.05|-0.21|0.2432
74052581|NCT02194699|147657327|SUPERIORITY||Rate ratio|0.39||||0.0576|TWO_SIDED|95.0|0.15|1.03|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.03|0.15|0.0576
74052582|NCT02194699|147657327|SUPERIORITY||Rate ratio|0.83||||0.5249|TWO_SIDED|95.0|0.46|1.48|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.48|0.46|0.5249
74052583|NCT02194699|147657327|SUPERIORITY||Rate ratio|0.67||||0.1155|TWO_SIDED|95.0|0.41|1.1|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: FAS population; Tralo 300 mg Q2W vs placebo.||1.10|0.41|0.1155
74052584|NCT02194699|147657329|SUPERIORITY||LS Mean difference|-0.95||||0.036|TWO_SIDED|95.0|-1.85|-0.06|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||-0.06|-1.85|0.0360
74052585|NCT02194699|147657329|SUPERIORITY||LS Mean difference|0.15||||0.5864|TWO_SIDED|95.0|-0.4|0.7|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.70|-0.40|0.5864
74099662|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.25||||0.017|TWO_SIDED|95.0|-0.46|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.05|-0.46|0.017
74052586|NCT02194699|147657329|SUPERIORITY||LS Mean difference|-0.17||||0.4689|TWO_SIDED|95.0|-0.63|0.29|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.29|-0.63|0.4689
74052587|NCT02194699|147657330|SUPERIORITY||LS Mean difference|6.15||||0.5094|TWO_SIDED|95.0|-12.13|24.43|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||24.43|-12.13|0.5094
74052588|NCT02194699|147657330|SUPERIORITY||LS Mean difference|3.02||||0.5984|TWO_SIDED|95.0|-8.22|14.26|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||14.26|-8.22|0.5984
74052589|NCT02194699|147657330|SUPERIORITY||LS Mean difference|7.84||||0.3971|TWO_SIDED|95.0|-10.32|26.0|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||26.00|-10.32|0.3971
74052590|NCT02194699|147657330|SUPERIORITY||LS Mean difference|3.59||||0.531|TWO_SIDED|95.0|-7.65|14.83|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||14.83|-7.65|0.5310
74052591|NCT02194699|147657330|SUPERIORITY||LS Mean difference|3.46||||0.4764|TWO_SIDED|95.0|-6.06|12.97|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in morning PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||12.97|-6.06|0.4764
74052592|NCT02194699|147657330|SUPERIORITY||LS Mean difference|3.88||||0.4221|TWO_SIDED|95.0|-5.6|13.37|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in evening PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||13.37|-5.60|0.4221
74052593|NCT02194699|147657331|SUPERIORITY||LS Mean difference|-5.04||||0.1099|TWO_SIDED|95.0|-11.21|1.14|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||1.14|-11.21|0.1099
74052594|NCT02194699|147657331|SUPERIORITY||LS Mean difference|0.46||||0.8112|TWO_SIDED|95.0|-3.33|4.25|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||4.25|-3.33|0.8112
74099663|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.039|TWO_SIDED|95.0|-0.43|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.01|-0.43|0.039
74099664|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.27||||0.015|TWO_SIDED|95.0|-0.48|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.05|-0.48|0.015
74099665|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.009|TWO_SIDED|95.0|-0.5|-0.07||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.07|-0.50|0.009
74099666|NCT00261443|147748790|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.28||||0.013|TWO_SIDED|95.0|-0.5|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.06|-0.50|0.013
74099667|NCT00261443|147748791|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.348||||0.013|TWO_SIDED|95.0|0.146|0.829||Stratified Log-rank Test, controlling for type of mood stabilizer and type of index mood episode.|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||0.829|0.146|0.013
74099668|NCT00261443|147748792|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.733||||0.384|TWO_SIDED|95.0|0.364|1.479||Stratified Log-rank Test P-value for Equality of Survival Curves|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||1.479|0.364|0.384
74099669|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.02||||0.955|TWO_SIDED|95.0|-0.73|0.77||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.77|-0.73|0.955
74099670|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.06||||0.895|TWO_SIDED|95.0|-0.83|0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.95|-0.83|0.895
74099671|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.69||||0.144|TWO_SIDED|95.0|-1.61|0.24||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.24|-1.61|0.144
74099672|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.1||||0.047|TWO_SIDED|95.0|-2.19|-0.01||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||-0.01|-2.19|0.047
74099673|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.39||||0.017|TWO_SIDED|95.0|-2.52|-0.25||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||-0.25|-2.52|0.017
74099674|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.91||||0.003|TWO_SIDED|95.0|-3.15|-0.68||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||-0.68|-3.15|0.003
74099675|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.18|||<|0.001|TWO_SIDED|95.0|-3.47|-0.89||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.89|-3.47|<0.001
74099676|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.62|||<|0.001|TWO_SIDED|95.0|-4.06|-1.19||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-1.19|-4.06|<0.001
74099677|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-3.7|-0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.95|-3.70|<0.001
74099678|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.78|||<|0.001|TWO_SIDED|95.0|-4.19|-1.37||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-1.37|-4.19|<0.001
74052595|NCT02194699|147657331|SUPERIORITY||LS Mean difference|-1.19||||0.4645|TWO_SIDED|95.0|-4.4|2.01|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in number (%) of awakenings at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||2.01|-4.40|0.4645
74052596|NCT02194699|147657332|SUPERIORITY||Odds Ratio (OR)|0.77||||0.344|TWO_SIDED|95.0|0.44|1.33|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.||1.33|0.44|0.3440
74099679|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.71|||<|0.001|TWO_SIDED|95.0|-4.13|-1.29||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-1.29|-4.13|<0.001
74052597|NCT02194699|147657332|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7768|TWO_SIDED|95.0|0.75|1.46|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.||1.46|0.75|0.7768
74052598|NCT02194699|147657332|SUPERIORITY||Odds Ratio (OR)|0.91||||0.5276|TWO_SIDED|95.0|0.69|1.21|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: FAS population; Tralo 300 mg Q2W vs placebo.||1.21|0.69|0.5276
74052599|NCT04853368|147657350|SUPERIORITY||LS Mean of Difference|2.6|STANDARD_ERROR_OF_MEAN|0.84||0.002|TWO_SIDED|90.0|1.22|4.04||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||4.04|1.22|0.002
74052600|NCT04853368|147657350|SUPERIORITY||LS Mean of Difference|1.3|STANDARD_ERROR_OF_MEAN|1.92||0.254|TWO_SIDED|90.0|-2.07|4.67||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||4.67|-2.07|0.254
74052601|NCT04853368|147657350|SUPERIORITY||LS Mean of Difference|0.9||||0.402|TWO_SIDED|90.0|-5.07|6.77||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||6.77|-5.07|0.402
74052602|NCT04853368|147657352|SUPERIORITY||LS Mean of Difference|5.5|STANDARD_ERROR_OF_MEAN|2.63||0.022|TWO_SIDED|90.0|1.07|9.92||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||9.92|1.07|0.022
74052603|NCT04853368|147657352|SUPERIORITY||LS Mean of Difference|-14.1||||0.043|TWO_SIDED|90.0|-27.59|-0.62||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||-0.62|-27.59|0.043
74052604|NCT04853368|147657353|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.047||0.003|TWO_SIDED|90.0|0.059|0.219||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.219|0.059|0.003
74052605|NCT04853368|147657353|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.089||0.475|TWO_SIDED|90.0|-0.162|0.15||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.150|-0.162|0.475
74052606|NCT04853368|147657353|SUPERIORITY||LS Mean of Difference|-0.06||||0.352|TWO_SIDED|90.0|-0.332|0.212||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||Cohort 2: Difference between Triple Therapy and Placebo||0.212|-0.332|0.352
74052607|NCT04853368|147657354|SUPERIORITY||LS Mean of Difference|0.089|STANDARD_ERROR_OF_MEAN|0.0403||0.017|TWO_SIDED|90.0|0.0209|0.1568||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.1568|0.0209|0.017
74052608|NCT04853368|147657354|SUPERIORITY||LS Mean of Difference|0.103|STANDARD_ERROR_OF_MEAN|0.1033||0.169|TWO_SIDED|90.0|-0.1814|0.288||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.2880|-0.1814|0.169
74052609|NCT04853368|147657354|SUPERIORITY||Mean Difference (Final Values)|0.136||||0.23|TWO_SIDED|90.0|-0.1809|0.4527||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.4527|-0.1809|0.230
74052610|NCT04853368|147657355|SUPERIORITY||LS Mean of Difference|4.4||||0.002|TWO_SIDED|90.0|2.04|6.78||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.78|2.04|0.002
74052611|NCT04853368|147657355|SUPERIORITY||LS Mean of Difference|1.3||||0.35|TWO_SIDED|90.0|-4.42|6.97||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.97|-4.42|0.350
74052612|NCT04853368|147657355|SUPERIORITY||LS Mean of Difference|1.3||||0.412|TWO_SIDED|90.0|-8.75|11.34||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.34|-8.75|0.412
73881553|NCT03192176|147297634|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|4.65||0.657|TWO_SIDED|95.0|-11.22|7.09||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||7.09|-11.22|0.6570
73881554|NCT03192176|147297634|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|4.73||0.231|TWO_SIDED|95.0|-15.0|3.64||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||3.64|-15.00|0.2310
74099680|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.92|||<|0.001|TWO_SIDED|95.0|-4.38|-1.46||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-1.46|-4.38|<0.001
73881555|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|4.77||0.9066|TWO_SIDED|95.0|-8.84|9.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||9.96|-8.84|0.9066
74052613|NCT04853368|147657356|SUPERIORITY||LS Mean of Difference|4.36|||<|0.001|TWO_SIDED|90.0|2.19|6.524||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.524|2.190|<0.001
74052614|NCT04853368|147657356|SUPERIORITY||LS Mean of Difference|-0.59||||0.396|TWO_SIDED|90.0|-4.449|3.268||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||3.268|-4.449|0.396
74052615|NCT04853368|147657356|SUPERIORITY||LS Mean of Difference|-2.0||||0.305|TWO_SIDED|90.0|-8.724|4.732||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||4.732|-8.724|0.305
74052616|NCT04853368|147657357|SUPERIORITY||LS Mean of Difference|6.475||||0.018|TWO_SIDED|90.0|1.4443|11.5056||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.5056|1.4443|0.018
74052617|NCT04853368|147657357|SUPERIORITY||LS Mean of Difference|6.019||||0.214|TWO_SIDED|90.0|-7.1464|19.1844||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||19.1844|-7.1464|0.214
74052618|NCT04853368|147657357|SUPERIORITY||LS Mean of Difference|7.29||||0.286|TWO_SIDED|90.0|-15.186|29.766||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||29.7660|-15.1860|0.286
74052619|NCT04853368|147657358|SUPERIORITY||LS Mean of Difference|5.6||||0.057|TWO_SIDED|90.0|-0.26|11.37||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.37|-0.26|0.057
74052620|NCT04853368|147657358|SUPERIORITY||LS Mean of Difference|8.6||||0.088|TWO_SIDED|90.0|-2.18|19.4||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||19.40|-2.18|0.088
74052621|NCT04853368|147657358|SUPERIORITY||LS Mean of Difference|11.2||||0.142|TWO_SIDED|90.0|-6.9|29.25||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Note: The LS mean is estimated using the linear regression on the change in CFQ-R from baseline to day 29.||||29.25|-6.90|0.142
73881556|NCT03192176|147297634|SUPERIORITY||LSMean differnce|-5.0|STANDARD_ERROR_OF_MEAN|4.71||0.2914|TWO_SIDED|95.0|-14.26|4.3||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||4.30|-14.26|0.2914
74052622|NCT00612573|147657360|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.75|STANDARD_DEVIATION|0.85||0.779|TWO_SIDED|95.0|-14.8|10.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||10.3|-14.8|0.779
74052623|NCT00612573|147657360|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.69|STANDARD_DEVIATION|0.9||0.983|TWO_SIDED|95.0|-13.7|11.7|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||11.7|-13.7|0.983
74052624|NCT00612573|147657360|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.92|STANDARD_DEVIATION|0.97||0.087|TWO_SIDED|95.0|-1.5|27.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||27.3|-1.5|0.087
74052625|NCT00612573|147657361|SUPERIORITY_OR_OTHER|||||||0.807||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.807
74052626|NCT00612573|147657361|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.075
74052627|NCT00612573|147657361|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.039
74052628|NCT00612573|147657362|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.212
74052629|NCT00612573|147657362|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.505
74052630|NCT00612573|147657362|SUPERIORITY_OR_OTHER|||||||0.399||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.399
74052631|NCT00612573|147657363|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.276
74052632|NCT00612573|147657363|SUPERIORITY_OR_OTHER|||||||0.231||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.231
74052633|NCT00612573|147657363|SUPERIORITY_OR_OTHER|||||||0.081||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.081
74052634|NCT04495166|147657373|SUPERIORITY|||||||0.757||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||The sample size was calculated based on an effect size of 0.65 on depression, which is based on a previous meta-analysis (Sockol et al., 2011). Sample size calculation considered a difference in means between two independent groups, probability of type I error of 5%, statistical power of 80%, a two-tailed test, and a dropout rate of 15%.||||0.757
74052635|NCT04495166|147657374|SUPERIORITY|||||||0.91||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.910
74052636|NCT04495166|147657376|SUPERIORITY|||||||0.442||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.442
74052637|NCT04495166|147657377|SUPERIORITY|||||||0.223||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.223
74052638|NCT04495166|147657378|SUPERIORITY|||||||0.54||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.540
74052639|NCT04495166|147657379|SUPERIORITY|||||||0.901||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.901
74052640|NCT04495166|147657380|SUPERIORITY|||||||0.748||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.748
74052641|NCT03938857|147657390|OTHER||Slope|-0.1088295|STANDARD_ERROR_OF_MEAN|0.4728041||0.814|TWO_SIDED|95.0|-1.035508|0.8178494|||Mixed Models Analysis||Estimated value represents interaction between treatment and days.|Placebo group compared to combined Dexmedetomidine groups.||0.8178494|-1.035508|0.814
74052642|NCT02516605|147657418|OTHER||adjusted fold change from baseline|0.86||||0.293|TWO_SIDED|90.0|0.68|1.09|||ANCOVA|||||1.09|0.68|0.293
74052643|NCT02516605|147657418|OTHER||adjusted fold change from baseline|0.47|||<|0.001|TWO_SIDED|90.0|0.37|0.6|||ANCOVA|||||0.60|0.37|<0.001
74052644|NCT02516605|147657418|OTHER||adjusted fold change from baseline|0.32|||<|0.001|TWO_SIDED|90.0|0.26|0.4|||ANCOVA|||||0.40|0.26|<.001
74099681|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-3.08|||<|0.001|TWO_SIDED|95.0|-4.59|-1.57||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-1.57|-4.59|<0.001
74099682|NCT00261443|147748794|SUPERIORITY_OR_OTHER_LEGACY||Difference|-3.04|||<|0.001|TWO_SIDED|95.0|-4.55|-1.54||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-1.54|-4.55|<0.001
74099683|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.2||||0.59|TWO_SIDED|95.0|-0.54|0.94||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.94|-0.54|0.590
74099684|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.5||||0.371|TWO_SIDED|95.0|-1.59|0.6||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.60|-1.59|0.371
73881557|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|4.64||0.9277|TWO_SIDED|95.0|-8.73|9.57||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||9.57|-8.73|0.9277
74052645|NCT02516605|147657418|OTHER||adjusted fold change from baseline|0.36|||<|0.001|TWO_SIDED|90.0|0.27|0.47|||ANCOVA|||||0.47|0.27|<.001
74052646|NCT02516605|147657428|OTHER||Median difference from baseline|1.0||||0.898|TWO_SIDED|90.0|-7.0|6.0|||Wilcoxon rank-sum test|Day 28||||6.0|-7.0|0.898
74052647|NCT02516605|147657428|OTHER||Median difference from baseline|2.0||||0.593|TWO_SIDED|90.0|-4.0|10.0|||Wilcoxon rank-sum test|Day 56||||10.0|-4.0|0.593
74052648|NCT02516605|147657428|OTHER||Median difference from baseline|-3.0||||0.509|TWO_SIDED|90.0|-11.0|4.0|||Wilcoxon rank-sum test|Day 84||||4.0|-11.0|0.509
74099685|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.04||||0.113|TWO_SIDED|95.0|-2.33|0.25||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.25|-2.33|0.113
73888145|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|29.6||||0.0006|TWO_SIDED|95.0|12.9|46.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.3|12.9|0.0006
74052649|NCT02516605|147657428|OTHER||Median difference from baseline|1.5||||0.591|TWO_SIDED|90.0|-5.0|7.0|||Wilcoxon rank-sum test|Day 28||||7.0|-5.0|0.591
74052650|NCT02516605|147657428|OTHER||Median difference from baseline|-2.0||||0.702|TWO_SIDED|90.0|-12.0|4.0|||Wilcoxon rank-sum test|Day 56||||4.0|-12.0|0.702
74052651|NCT02516605|147657428|OTHER||Median difference from baseline|-1.0||||0.838|TWO_SIDED|90.0|-10.0|8.0|||Wilcoxon rank-sum test|Day 84||||8.0|-10.0|0.838
74052652|NCT02516605|147657428|OTHER||Median difference from baseline|4.0||||0.297|TWO_SIDED|90.0|-3.0|8.0|||Wilcoxon rank-sum test|Day 28||||8.0|-3.0|0.297
74052653|NCT02516605|147657428|OTHER||Median difference from baseline|-6.0||||0.236|TWO_SIDED|90.0|-14.0|1.0|||Wilcoxon rank-sum test|Day 56||||1.0|-14.0|0.236
74052654|NCT02516605|147657428|OTHER||Median difference from baseline|-6.5||||0.192|TWO_SIDED|90.0|-15.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-15.0|0.192
74052655|NCT02516605|147657428|OTHER||Median difference from baseline|2.0||||0.605|TWO_SIDED|90.0|-2.0|9.0|||Wilcoxon rank-sum test|Day 28||||9.0|-2.0|0.605
74099686|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.0||||0.128|TWO_SIDED|95.0|-2.28|0.29||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.29|-2.28|0.128
74019429|NCT03988907|147591038|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.11|||||TWO_SIDED|90.0|1.02|1.2||||||||1.20|1.02|
74019430|NCT03988907|147591039|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.16|||||TWO_SIDED|90.0|1.06|1.28||||||||1.28|1.06|
74019431|NCT03988907|147591040|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.12|||||TWO_SIDED|90.0|0.99|1.27||||||||1.27|0.99|
74019432|NCT03988907|147591041|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.2|||||TWO_SIDED|90.0|1.11|1.3||||||||1.30|1.11|
74019433|NCT03988907|147591042|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.27|||||TWO_SIDED|90.0|1.14|1.41||||||||1.41|1.14|
74052656|NCT02516605|147657428|OTHER||Median difference from baseline|-11.0||||0.037|TWO_SIDED|90.0|-21.0|-1.0|||Wilcoxon rank-sum test|Day 56||||-1.0|-21.0|0.037
74019434|NCT01307033|147591104|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|0.2|||||TWO_SIDED|95.0|-1.7|2.2|||Constained logitudinal data analysis|Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups||||2.2|-1.7|
74019435|NCT01307033|147591105|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-2.3|||||TWO_SIDED|95.0|-5.0|0.5|||Constained longitudinal data analysis|Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups||||0.5|-5.0|
74019436|NCT00947531|147591115|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.17|||<|0.0001|TWO_SIDED|95.0|-8.22|-4.13||P-value obtained from the F-test statistic of Cerebrolysin versus Placebo as part of ANCOVA (analysis of covariance). No adjustment for multiple comparisons was needed. The overall significance level alpha was fixed at alpha = 0.05 (two-sided).|ANCOVA|The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple comparisons was needed.||The null-hypothesis stated no difference between the two treatment groups. A sample size of 103 evaluable patients per treatment group was estimated to allow for the detection of a significant group difference of 4.1 points in ADAS-cog+ weak 24 change score (standard deviation \[SD\] 9.0) in favor of Cerebrolysin with a power of 90% and a probability level of alpha-level 0.025 (one-sided).||-4.13|-8.22|< 0.0001
74019437|NCT01773421|147591145|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric Least Square (LS) Mean Ratio|1.06|||||TWO_SIDED|90.0|0.97|1.15||||||||1.15|0.97|
74019438|NCT01773421|147591146|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.11|||||TWO_SIDED|90.0|1.02|1.2||||||||1.2|1.02|
74019439|NCT01773421|147591147|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.13|||||TWO_SIDED|90.0|1.0|1.27||||||||1.27|1|
74019440|NCT02804763|147591170|SUPERIORITY||||||=|0.0727||||||The lowest p-value (z-statistic with the highest value) was used to establish proof of dose response.|MCP-Mod|||"Multiple contrast testing (MCP-mod methodology) was used to test for a statistically significant dose-response relationship between the primary endpoint (BICLA at Week 24) and dose, which would indicate a drug effect of DZP over Placebo.~The best fitting statistically significant model could be used to estimate the dose needed to achieve desired treatment effect."||||=0.0727
74019441|NCT02804763|147591171|SUPERIORITY||Odds Ratio (OR)|1.6|||=|0.2699|TWO_SIDED|95.0|0.7|3.8||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||3.8|0.7|=0.2699
74052657|NCT02516605|147657428|OTHER||Median difference from baseline|-3.5||||0.397|TWO_SIDED|90.0|-11.0|3.0|||Wilcoxon rank-sum test|Day 84||||3.0|-11.0|0.397
74052658|NCT02516605|147657429|OTHER||Median difference from baseline|1.0||||0.342|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 28||||2.0|-1.0|0.342
74052659|NCT02516605|147657429|OTHER||Median difference from baseline|0.0||||0.699|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|-1.0|0.699
74052660|NCT02516605|147657429|OTHER||Median difference from baseline|-1.0||||0.377|TWO_SIDED|90.0|-3.0|0.0|||Wilcoxon rank-sum test|Day 84||||0.0|-3.0|0.377
74052661|NCT02516605|147657429|OTHER||Median difference from baseline|1.0||||0.132|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 28||||2.0|0.0|0.132
74052662|NCT02516605|147657429|OTHER||Median difference from baseline|1.0||||0.292|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|0.0|0.292
74052663|NCT02516605|147657429|OTHER||Median difference from baseline|0.0||||0.979|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|0.979
74052664|NCT02516605|147657429|OTHER||Median difference from baseline|2.0||||0.102|TWO_SIDED|90.0|0.0|4.0|||Wilcoxon rank-sum test|Day 28||||4.0|0.0|0.102
74052665|NCT02516605|147657429|OTHER||Median difference from baseline|0.0||||0.717|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|-1.0|0.717
74052666|NCT02516605|147657429|OTHER||Median difference|0.0||||1|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|1.000
74052667|NCT02516605|147657429|OTHER||Median difference from baseline|2.0||||0.142|TWO_SIDED|90.0|0.0|5.0|||Wilcoxon rank-sum test|Day 28||||5.0|0.0|0.142
74052668|NCT02516605|147657429|OTHER||Median difference from baseline|0.0||||0.975|TWO_SIDED|90.0|-1.0|1.0|||Wilcoxon rank-sum test|Day 56||||1.0|-1.0|0.975
74052669|NCT02516605|147657429|OTHER||Median difference from baseline|0.0||||0.602|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|0.602
74052670|NCT02516605|147657430|OTHER||Mean difference from baseline|-2.78|STANDARD_ERROR_OF_MEAN|8.436||0.743|TWO_SIDED|90.0|-16.91|11.34|||ANCOVA|Day 7||||11.34|-16.91|0.743
74052671|NCT02516605|147657430|OTHER||Median difference from baseline|-14.07|STANDARD_ERROR_OF_MEAN|8.229||0.093|TWO_SIDED|90.0|-27.85|-0.28|||ANCOVA|Day 14||||-0.28|-27.85|0.093
74052672|NCT02516605|147657430|OTHER||Median difference from baseline|7.78|STANDARD_ERROR_OF_MEAN|8.71||0.376|TWO_SIDED|90.0|-6.81|22.38|||ANCOVA|Day 21||||22.38|-6.81|0.376
74052673|NCT02516605|147657430|OTHER||Median difference from baseline|7.03|STANDARD_ERROR_OF_MEAN|9.187||0.448|TWO_SIDED|90.0|-8.36|22.43|||ANCOVA|Day 28||||22.43|-8.36|0.448
74052674|NCT02516605|147657430|OTHER||Median difference from baseline|-15.25|STANDARD_ERROR_OF_MEAN|7.192||0.039|TWO_SIDED|90.0|-27.3|-3.19|||ANCOVA|Day 56||||-3.19|-27.30|0.039
74052675|NCT02516605|147657430|OTHER||Median difference from baseline|-16.93|STANDARD_ERROR_OF_MEAN|8.592||0.054|TWO_SIDED|90.0|-31.31|-2.54|||ANCOVA|Day 84||||-2.54|-31.31|0.054
74052676|NCT02516605|147657430|OTHER||Median difference from baseline|11.34|STANDARD_ERROR_OF_MEAN|8.434||0.185|TWO_SIDED|90.0|-2.78|25.46|||ANCOVA|Day 7||||25.46|-2.78|0.185
74052677|NCT02516605|147657430|OTHER||Median difference from baseline|7.74|STANDARD_ERROR_OF_MEAN|8.226||0.351|TWO_SIDED|90.0|-6.05|21.52|||ANCOVA|Day 14||||21.52|-6.05|0.351
74052678|NCT02516605|147657430|OTHER||Median difference from baseline|16.79|STANDARD_ERROR_OF_MEAN|8.707||0.059|TWO_SIDED|90.0|2.2|31.38|||ANCOVA|day 21||||31.38|2.20|0.059
74052679|NCT02516605|147657430|OTHER||Median difference from baseline|14.05|STANDARD_ERROR_OF_MEAN|9.184||0.132|TWO_SIDED|90.0|-1.35|29.44|||ANCOVA|Day 28||||29.44|-1.35|0.132
74052680|NCT02516605|147657430|OTHER||Median difference from baseline|-1.75|STANDARD_ERROR_OF_MEAN|7.19||0.809|TWO_SIDED|90.0|-13.8|10.31|||ANCOVA|Day 56||||10.31|-13.80|0.809
74052681|NCT02516605|147657430|OTHER||Median difference from baseline|-10.9|STANDARD_ERROR_OF_MEAN|8.59||0.21|TWO_SIDED|90.0|-25.29|3.48|||ANCOVA|Day 84||||3.48|-25.29|0.210
74052682|NCT02516605|147657430|OTHER||Median difference from baseline|13.92|STANDARD_ERROR_OF_MEAN|7.963||0.086||90.0|0.58|27.25|||ANCOVA|day 7||||27.25|0.58|0.086
74052683|NCT02516605|147657430|OTHER||Median difference from baseline|0.48|STANDARD_ERROR_OF_MEAN|7.787||0.951|TWO_SIDED|90.0|-12.57|13.53|||ANCOVA|Day 14||||13.53|-12.57|0.951
74052684|NCT02516605|147657430|OTHER||Median difference from baseline|5.02|STANDARD_ERROR_OF_MEAN|8.244||0.545|TWO_SIDED|90.0|-8.79|18.83|||ANCOVA|day 21||||18.83|-8.79|0.545
74052685|NCT02516605|147657430|OTHER||Median difference from baseline|0.19|STANDARD_ERROR_OF_MEAN|8.697||0.982|TWO_SIDED|90.0|-14.38|14.77|||ANCOVA|Day 28||||14.77|-14.38|0.982
74052686|NCT02516605|147657430|OTHER||Median difference from baseline|-13.82|STANDARD_ERROR_OF_MEAN|6.797||0.047|TWO_SIDED|90.0|-25.21|-2.43|||ANCOVA|day 56||||-2.43|-25.21|0.047
74052687|NCT02516605|147657430|OTHER||Median difference from baseline|-18.23|STANDARD_ERROR_OF_MEAN|8.11||0.029|TWO_SIDED|90.0|-31.81|-4.64|||ANCOVA|Day 84||||-4.64|-31.81|0.029
74052688|NCT02516605|147657430|OTHER||Median difference from baseline|26.7|STANDARD_ERROR_OF_MEAN|8.799||0.004|TWO_SIDED|90.0|11.97|41.44|||ANCOVA|Day 7||||41.44|11.97|0.004
74052689|NCT02516605|147657430|OTHER||Median difference from baseline|8.17|STANDARD_ERROR_OF_MEAN|9.032||0.37|TWO_SIDED|90.0|-6.96|23.29|||ANCOVA|Day 14||||23.29|-6.96|0.370
74052690|NCT02516605|147657430|OTHER||Median difference from baseline|5.9|STANDARD_ERROR_OF_MEAN|10.014||0.558|TWO_SIDED|90.0|-10.86|22.66|||ANCOVA|Day 21||||22.66|-10.86|0.558
74052691|NCT02516605|147657430|OTHER||Median difference from baseline|8.91|STANDARD_ERROR_OF_MEAN|10.911||0.418|TWO_SIDED|90.0|-9.34|27.15|||ANCOVA|Day 28||||27.15|-9.34|0.418
74052692|NCT02516605|147657430|OTHER||Median difference from baseline|-11.08|STANDARD_ERROR_OF_MEAN|7.69||0.156|TWO_SIDED|90.0|-23.95|1.8|||ANCOVA|Day 56||||1.80|-23.95|0.156
74052693|NCT02516605|147657430|OTHER||Median difference from baseline|-16.93|STANDARD_ERROR_OF_MEAN|8.961||0.064|TWO_SIDED|90.0|-31.94|-1.92|||ANCOVA|Day 84||||-1.92|-31.94|0.064
73881558|NCT03192176|147297634|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.64||0.9367|TWO_SIDED|95.0|-9.51|8.77||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||8.77|-9.51|0.9367
73881559|NCT03192176|147297634|SUPERIORITY||LSMean difference|5.1|STANDARD_ERROR_OF_MEAN|4.35||0.2407|TWO_SIDED|95.0|-3.46|13.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||13.69|-3.46|0.2407
73881560|NCT03192176|147297634|SUPERIORITY||LSMean difference|6.9|STANDARD_ERROR_OF_MEAN|4.55||0.1305|TWO_SIDED|95.0|-2.06|15.89||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||15.89|-2.06|0.1305
73881561|NCT03192176|147297634|SUPERIORITY||LSMean difference|5.7|STANDARD_ERROR_OF_MEAN|4.59||0.2152|TWO_SIDED|95.0|-3.34|14.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||14.75|-3.34|0.2152
73881562|NCT03192176|147297634|SUPERIORITY||LSMean difference|7.6|STANDARD_ERROR_OF_MEAN|4.72||0.1099|TWO_SIDED|95.0|-1.73|16.89||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||16.89|-1.73|0.1099
73881563|NCT03192176|147297634|SUPERIORITY||LSMean difference|7.4|STANDARD_ERROR_OF_MEAN|4.75||0.1219|TWO_SIDED|95.0|-1.99|16.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||16.75|-1.99|0.1219
74052694|NCT02577107|147657431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.314|STANDARD_ERROR_OF_MEAN|4.1613|||TWO_SIDED|95.0|9.618|31.011||||||||31.011|9.618|
74052695|NCT03287089|147657460|SUPERIORITY||Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|95.0|0.49|2.43|||Chi-squared|||||2.43|0.49|0.84
74052696|NCT03287089|147657461|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.44
74052697|NCT03287089|147657462|SUPERIORITY|||||||0.68|||||||t-test, 1 sided|||||||0.68
74052698|NCT04880642|147657463|SUPERIORITY|"The null hypothesis was that the there was no difference in survival up to Day 60 between the two groups and was to be rejected in favour of the alternative hypothesis i.e. a difference in survival up to Day 60 between the two groups excisted.~The overall 2-sided significance level of 5% was applied to the primary endpoint."|Hazard Ratio (HR)|0.98||||0.949|TWO_SIDED|95.0|0.4|2.36|||Log Rank|||||2.36|0.40|0.949
73881564|NCT03192176|147297634|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|4.44||0.0316|TWO_SIDED|95.0|0.85|18.36||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||18.36|0.85|0.0316
73881565|NCT03192176|147297634|SUPERIORITY||LSMean difference|6.4|STANDARD_ERROR_OF_MEAN|4.47||0.1557|TWO_SIDED|95.0|-2.44|15.16||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||15.16|-2.44|0.1557
73881566|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.97||0.8592|TWO_SIDED|95.0|-8.91|10.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||10.67|-8.91|0.8592
73881567|NCT03192176|147297634|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|5.15||0.6891|TWO_SIDED|95.0|-8.08|12.2||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||12.20|-8.08|0.6891
73888146|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.0072|TWO_SIDED|95.0|6.3|39.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.5|6.3|0.0072
74052699|NCT04880642|147657464|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.301|TWO_SIDED|95.0|0.91|1.52|||Log Rank|||||1.52|0.91|0.301
74052700|NCT04880642|147657465|SUPERIORITY||Median Difference (Final Values)|0.0||||0.425|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-1|0.425
74052701|NCT04880642|147657466|SUPERIORITY||Risk Difference (RD)|-1.7|STANDARD_ERROR_OF_MEAN|3.91||0.671|TWO_SIDED|95.0|-9.3|6.0|||Regression, Logistic|||||6.0|-9.3|0.671
74052702|NCT04880642|147657467|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|5.62||0.948|TWO_SIDED|95.0|-11.4|10.6|||Regression, Logistic|||||10.6|-11.4|0.948
74052703|NCT00104299|147657468|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of -20%|Difference between group success rates|10.6|||<|0.001||95.1|-3.2|24.3||P-value is adjusted for interim analysis using a Lan-DeMets alpha spending function with an O'Brien-Fleming boundary, allocating 0.003 alpha to the interim analysis and 0.049 alpha to the final analysis.|95.1% CI of difference|Calculate 95.1% CI around the difference in success rates between arms. Lower bound above non-inferiority margin of -20% indicates non-inferiority.||In calculating the sample size, we assumed that the percentage of patients in both treatment groups would achieve disease remission off prednisone by 6 months was 70%. We specified a non-inferiority margin of -20% on the difference in remission rates (rituximab rate minus cyclophosphamide rate) and a one-sided 0.025 level test. Assuming a 10% dropout rate, RAVE required 100 patients in each arm to have 83% power to conclude non-inferiority.||24.3|-3.2|<0.001
73888147|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0||||0.0035|TWO_SIDED|95.0|8.4|41.6|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||41.6|8.4|0.0035
74052704|NCT00104299|147657469|SUPERIORITY_OR_OTHER|||||||0.927||||||P-value is from the Poisson regression model adjusting for clinical study site and ANCA type. The natural logarithm of participant-months is used as an offset in this model|Poisson regression model|||Participant-months are defined as duration in months from the first study drug dosing date to the last date of the participant in the protocol. The rate of selected AEs is defined as the total number of selected AEs divided by total participant-months, and indicates the number of events per participant per month on average. Participants are grouped according to their originally received treatment.||||0.927
74099687|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.85||||0.205|TWO_SIDED|95.0|-2.16|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.47|-2.16|0.205
74099688|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.13||||0.125|TWO_SIDED|95.0|-2.59|0.32||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.32|-2.59|0.125
74099689|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.43||||0.061|TWO_SIDED|95.0|-2.92|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.06|-2.92|0.061
74099690|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.51||||0.06|TWO_SIDED|95.0|-3.07|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.06|-3.07|0.060
74099691|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.62||||0.046|TWO_SIDED|95.0|-3.21|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.03|-3.21|0.046
74099692|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.15||||0.164|TWO_SIDED|95.0|-2.77|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.47|-2.77|0.164
74099693|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.53||||0.066|TWO_SIDED|95.0|-3.16|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.10|-3.16|0.066
74099694|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.57||||0.066|TWO_SIDED|95.0|-3.24|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.10|-3.24|0.066
74099695|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.08||||0.014|TWO_SIDED|95.0|-3.73|-0.43||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.43|-3.73|0.014
74099696|NCT00261443|147748796|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.01||||0.019|TWO_SIDED|95.0|-3.68|-0.34||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.34|-3.68|0.019
74099697|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.05||||0.597|TWO_SIDED|95.0|-0.13|0.22||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.22|-0.13|0.597
74099698|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.02||||0.838|TWO_SIDED|95.0|-0.17|0.21||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.21|-0.17|0.838
74099699|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.291|TWO_SIDED|95.0|-0.32|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.10|-0.32|0.291
74099700|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.219|TWO_SIDED|95.0|-0.37|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.08|-0.37|0.219
74099701|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.18||||0.133|TWO_SIDED|95.0|-0.41|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.05|-0.41|0.133
74099702|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.21||||0.092|TWO_SIDED|95.0|-0.46|0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.04|-0.46|0.092
74099703|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.018|TWO_SIDED|95.0|-0.56|-0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.05|-0.56|0.018
74099704|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.029|TWO_SIDED|95.0|-0.56|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.03|-0.56|0.029
74019442|NCT02804763|147591171|SUPERIORITY||Odds Ratio (OR)|2.0|||=|0.1036|TWO_SIDED|95.0|0.9|4.8||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||4.8|0.9|=0.1036
74052705|NCT00104299|147657470|SUPERIORITY_OR_OTHER||95.1% Confidence Interval of Difference|10.6||||0.133|TWO_SIDED|95.1|-3.2|24.4|||Chi-squared|At 6 months, the confidence interval is 95.1%.||The p-value is from a chi-square test.||24.4|-3.2|0.133
74052706|NCT00104299|147657471|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.761|TWO_SIDED|95.0|0.5|1.7||The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission|Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit||1.7|0.5|0.761
74052707|NCT00104299|147657472|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.861|TWO_SIDED|95.0|0.6|1.5|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit||1.5|0.6|0.861
74099705|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.024|TWO_SIDED|95.0|-0.57|-0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.04|-0.57|0.024
73888148|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|248.4|||<|0.0001|TWO_SIDED|95.0|188.6|308.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||308.3|188.6|<0.0001
74052708|NCT00104299|147657473|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.497|TWO_SIDED|95.0|0.7|1.3|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.|||1.3|0.7|0.497
74052709|NCT00104299|147657474|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3||||0.147|TWO_SIDED|95.0|0.9|1.8|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving complete remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.|||1.8|0.9|0.147
74099706|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.035|TWO_SIDED|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.02|-0.56|0.035
74099707|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.038|TWO_SIDED|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.02|-0.56|0.038
74099708|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.34||||0.015|TWO_SIDED|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.07|-0.62|0.015
74099709|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.39||||0.006|TWO_SIDED|95.0|-0.67|-0.12||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.12|-0.67|0.006
74099710|NCT00261443|147748798|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.35||||0.015|TWO_SIDED|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.07|-0.62|0.015
74099711|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.588|TWO_SIDED|95.0|-0.09|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.16|-0.09|0.588
74099712|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.01||||0.922|TWO_SIDED|95.0|-0.18|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.16|-0.18|0.922
74099713|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.266|TWO_SIDED|95.0|-0.3|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.08|-0.30|0.266
74099714|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.159|TWO_SIDED|95.0|-0.34|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.06|-0.34|0.159
74099715|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.305|TWO_SIDED|95.0|-0.31|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.10|-0.31|0.305
74052710|NCT00104299|147657475|SUPERIORITY_OR_OTHER|||||||0.504||95.0|||||Chi-squared|||Proportions of subjects experiencing a serious adverse event through 18 months and prior to censoring for open-label, crossover, or best medical judgment according to originally assigned treatment arm were compared using a two-sided Chi-squared test.||||0.504
74052711|NCT00724594|147657495|OTHER|||||||0.9||||||not significant|t-test, 2 sided|||Term infant cohort : NAC vs control H0= there will be no difference in resistive index in Middle Cerebral Artery after N-acetylcysteine or saline in the term cohort.||||0.9
74052712|NCT00724594|147657495|OTHER|||||||0.9|||||||t-test, 2 sided|||Preterm infant cohort: NAC vs control H0= there will be no difference in resisitive index in MCA after N-acetylcysteine or saline in preterm cohort||||0.9
74052713|NCT00724594|147657496|OTHER|||||||0.9||||||not significant|t-test, 2 sided|||Maternal cohort: NAC versus control l H0= PT will not be different in mothers after NAC or saline||||0.9
74052714|NCT00724594|147657496|OTHER|||||||0.9|||||||t-test, 2 sided|||Infant cohort: NAC versus control H0= prothrombin time will not be different in the infants after NAC or saline||||0.9
74052715|NCT00724594|147657497|OTHER|||||||0.072|||||||t-test, 2 sided|||correcting for gestational age at birth||||0.072
74052716|NCT00724594|147657498|OTHER|||||||0.014|||||||t-test, 2 sided|||||||0.014
74052717|NCT01351415|147657518|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.84||||0.1044|TWO_SIDED|90.0|0.71|1.0|||Stratified Log-Rank test|||The stratification factors for Log-Rank test and Hazard Ratio (HR) are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to first PD and smoking status.||1.00|0.71|0.1044
74052718|NCT01351415|147657519|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.83||||0.0573|TWO_SIDED|90.0|0.7|0.98|||Stratified Log-Rank test|||PFS 2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.98|0.70|0.0573
74052719|NCT01351415|147657519|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.63||||0.0045|TWO_SIDED|90.0|0.49|0.83|||Stratified Log-Rank test|||PFS 3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.83|0.49|0.0045
74052720|NCT01351415|147657520|SUPERIORITY_OR_OTHER||Estimated difference in response rate|0.0237||||0.081|TWO_SIDED|90.0|-0.0156|0.063|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.0630|-0.0156|0.0810
74052721|NCT01351415|147657521|SUPERIORITY_OR_OTHER||Estimated difference in Disease Control|0.0326||||0.0218|TWO_SIDED|90.0|-0.0288|0.094|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.0940|-0.0288|0.0218
74052722|NCT01351415|147657522|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.29||||0.06|TWO_SIDED|90.0|0.09|0.9|||Stratified Log-Rank test|||The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.90|0.09|0.0600
74052723|NCT01351415|147657524|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.79||||0.0311|TWO_SIDED|90.0|0.65|0.95|||Stratified Log-Rank test|||TTP2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.95|0.65|0.0311
74052724|NCT01351415|147657524|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.69||||0.0326|TWO_SIDED|90.0|0.52|0.92|||Stratified Log-Rank test|||TTP3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.92|0.52|0.0326
74052725|NCT01646255|147657536|SUPERIORITY_OR_OTHER||Least Square Mean|-1.2|||=|0.0002|TWO_SIDED|95.0|-1.83|-0.57||Primary efficacy analyses was made with confirmatory 2-sided test with significance level 0.05.|ANCOVA|||"Estimate of treatment effect has been obtained from an analysis of covariance (ANCOVA) model to the change from Baseline value in absolute time spent off. The ANCOVA model contained treatment and (pooled) site as factors and Baseline off time as covariate. A last observation carried forward (LOCF) imputation approach was used for missing values (during both Titration and Maintenance Periods) for the primary efficacy analysis."||-0.57|-1.83|=0.0002
74052726|NCT02380703|147657553|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.29|TWO_SIDED|95.0|0.78|2.32||For participants who dropped out, their time until study attrition was used as the exposure period; and they were carried forward as part of the overall incidence count.|Regression, Cox|||Sample-size calculations were performed, based on the ability to detect a small-to-moderate difference (Cohen's h = 0.4) in rate of aggression onset over a 1-year period between APT and EU-PC, assuming 80% power and a type I error rate of 5%. Given an anticipated rate of aggression onset over 1 year of 37% for EU-PC, an ES of h = 0.4 allows detection of aggression onset in APT as high as 19%. Given this effect size and up to 10% attrition, our goal was to include 220 total participants.||2.32|0.78|0.29
74052727|NCT02380703|147657553|EQUIVALENCE|Examination of whether the presence of aggression is equivalent between APT and EU-PC|Difference in frequencies|1.21||||0.27|TWO_SIDED|||||Association between presence of aggression and condition (APT vs EU-PC).|Chi-squared|X2(1) = 1.21||||||0.27
74052728|NCT02380703|147657554|SUPERIORITY||F-statistic|1.59||||0.19|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.19
74052729|NCT02380703|147657555|SUPERIORITY||F-statistic|2.43||||0.06|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.06
73888149|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|68.2||||0.0263|TWO_SIDED|95.0|8.2|128.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||128.2|8.2|0.0263
74052730|NCT02380703|147657556|SUPERIORITY||F-statistic|0.33||||0.8|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.80
74052731|NCT02380703|147657557|SUPERIORITY||F-statistic|0.21||||0.89|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.89
74052732|NCT02380703|147657558|SUPERIORITY||F-statistic|1.48||||0.22|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.22
74052733|NCT02380703|147657559|SUPERIORITY||F-statistic|0.38||||0.77|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.77
74052734|NCT02380703|147657560|SUPERIORITY||F-statistic|0.56||||0.64|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.64
74052735|NCT00890396|147657584|SUPERIORITY|||||||0.67|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.67
74052736|NCT00890396|147657585|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||>0.99
74052737|NCT00890396|147657586|SUPERIORITY|||||||0.61|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.61
74052738|NCT00890396|147657587|SUPERIORITY|||||||0.78|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.78
74052739|NCT00890396|147657588|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.80
74052740|NCT00890396|147657589|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.11
74099716|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.13||||0.251|TWO_SIDED|95.0|-0.35|0.09||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.09|-0.35|0.251
73888150|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|151.2|||<|0.0001|TWO_SIDED|95.0|91.3|211.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||211.1|91.3|<0.0001
74052741|NCT00890396|147657590|SUPERIORITY|||||||0.85|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.85
74052742|NCT00890396|147657591|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.95
74052743|NCT00890396|147657592|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.40
74052744|NCT00890396|147657593|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.11
74052745|NCT02504424|147657596|OTHER||percent of breasts successfully exchange|100.0|||||ONE_SIDED|||||||||Treatment Success includes all breasts which were exchanged successfully in the Per Protocol Cohort, excluding non-device related failures. The Treatment Success Rate per breast is 100% (80/80). Note: Denominator = 80 (86 implanted breasts - 6 breasts). Failed exchange = 4 breasts (non-device related) \& Missing = 2 breasts (patient non-compliant w/study and withdrew consent after treatment).||||
74052746|NCT02504424|147657596|OTHER||% breasts successfully exchanged|100.0|||||ONE_SIDED|||||||||Sensitivity Analysis (Best / Worst Case): Treatment Success by subject for the Per Protocol cohort includes all failures (excluding non-device related failures). The best case analysis considers success if the subject has at least one breast successfully reconstructed, and the worst case analysis considers it a failure if at least one breast has failed. The treatment success by subject is 100% for both best and worst case analysis.||||
74052747|NCT02504424|147657597|OTHER||% breasts successfully exchanged|95.2|||||ONE_SIDED|||||||||Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in analysis as subject withdrew from the study prior to exchange of her expanders.||||
74052748|NCT00819052|147657598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -12%|Cochran's statistic|1.0||||||95.0|-4.3|6.2|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||6.2|-4.3|
74052749|NCT00819052|147657611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.64||||0.7587||95.0|-34.34|25.05|||ANCOVA|Means adjusted for background ARV (Antiretroviral) stratum||||25.05|-34.34|0.7587
74052750|NCT00982111|147657659|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.9561|TWO_SIDED|95.0|0.84|1.21|||Log Rank|||||1.21|0.84|0.9561
74052751|NCT00982111|147657660|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.6647|TWO_SIDED|95.0|0.8|1.16|||Log Rank|||||1.16|0.80|0.6647
74099717|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.17||||0.135|TWO_SIDED|95.0|-0.4|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.05|-0.40|0.135
74099718|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.073|TWO_SIDED|95.0|-0.46|0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.02|-0.46|0.073
74052752|NCT00982111|147657661|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.7945|TWO_SIDED|95.0|0.68|1.34|||Cochran-Mantel-Haenszel|||||1.34|0.68|0.7945
74052753|NCT00982111|147657662|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.18||||0.0459|TWO_SIDED|95.0|1.0|1.39|||Log Rank|||||1.39|1.00|0.0459
74052754|NCT03512028|147657679|SUPERIORITY||Mean Difference (Net)|3.2||||0.002|TWO_SIDED|||||Interaction effect of group x time from pre- to post- intervention|ANOVA||Estimated difference between slopes|Mixed model ANOVA with group (RLIC, Sham) and time (pre-, post-, and follow-up ). The main analysis of interest is the group x time interaction from pre- to post-.||||0.002
74052755|NCT03512028|147657679|SUPERIORITY|||||||0.001||||||Main effect of time|ANOVA|||||||0.001
74052756|NCT03512028|147657679|SUPERIORITY|||||||0.844||||||Main effect of group|ANOVA|||||||0.844
74052757|NCT00661362|147657747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.55|-0.29|||ANCOVA|||||-0.29|-0.55|<0.0001
74052758|NCT00661362|147657748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.149|<|0.0002|TWO_SIDED|95.0|-0.85|-0.26|||ANCOVA|||||-0.26|-0.85|<0.0002
74099719|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.26||||0.034|TWO_SIDED|95.0|-0.5|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.02|-0.50|0.034
74052759|NCT00661362|147657749|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.1|STANDARD_ERROR_OF_MEAN|2.684|<|0.0002|TWO_SIDED|95.0|-15.37|-4.83|||ANCOVA|||||-4.83|-15.37|<0.0002
74052760|NCT00661362|147657750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-155.0|STANDARD_ERROR_OF_MEAN|55.0||0.0052|TWO_SIDED|95.0|-264.0|-47.0|||ANCOVA|||||-47|-264|0.0052
74052761|NCT00661362|147657751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2802.0|STANDARD_ERROR_OF_MEAN|989.8||0.0052|TWO_SIDED|95.0|-4753.0|-852.0|||ANCOVA|||||-852|-4753|0.0052
74052762|NCT00661362|147657752|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.1|||<|0.0001|TWO_SIDED|95.0|8.0|24.0|||ANCOVA|||||24.0|8.0|<0.0001
74052763|NCT01453439|147657766|SUPERIORITY||Slope|-0.4602|STANDARD_ERROR_OF_MEAN|0.1249|<|0.01|TWO_SIDED|||||Degrees of freedom=90.9|Mixed Models Analysis|Effect of interest: time by group interaction|The estimated value describes the mean slope difference of CBT compared to SPT.|"We compared the difference in the rate of change in BDD symptom severity over time (during treatment phase) between the randomized treatment groups (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in BDD symptom severity in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||<.01
74052764|NCT01453439|147657766|SUPERIORITY||Slope|-0.00984|STANDARD_ERROR_OF_MEAN|0.1038||0.62|TWO_SIDED|||||Degrees of freedom=74.7|Mixed Models Analysis|The effect of interest was the time by group interaction.|The estimated value describes the mean slope difference of CBT compared to SPT during follow-up (week 24 to week 50).|"We compared the difference in the rate of change in BDD symptom severity over time (during the follow-up phase) between the randomized treatment groups (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in BDD symptom severity during follow-up will not differ significantly between CBT and SPT treatments \[to be tested\]."||||.62
74052765|NCT01453439|147657767|SUPERIORITY|||||||0.1||||||Degrees of freedom=93.2|Mixed Models Analysis|||"We compared the change in Patient Insight over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in insight in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.10
74052766|NCT01453439|147657767|SUPERIORITY|||||||0.45||||||Degrees of freedom=74.5|Mixed Models Analysis|||"We compared the change in Patient Insight over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in insight in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.45
74052767|NCT01453439|147657768|SUPERIORITY|||||||0.05||||||Degrees of freedom=89.1|Mixed Models Analysis|||"We compared the change in depressive symptoms over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in depressive symptoms in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.05
74052768|NCT01453439|147657768|SUPERIORITY|||||||0.26||||||Degrees of freedom=63.7|Mixed Models Analysis|||"We compared the change in depressive symptoms over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in depressive symptoms in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.26
74052769|NCT01453439|147657769|SUPERIORITY|||||||0.04||||||Degrees of freedom=91.4|Mixed Models Analysis|||"We compared the change in Quality of life satisfaction over time (During treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in Quality of life satisfaction severity in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.04
74019443|NCT02804763|147591171|SUPERIORITY||Odds Ratio (OR)|1.9|||=|0.1518|TWO_SIDED|95.0|0.8|4.3||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||4.3|0.8|=0.1518
74052770|NCT01453439|147657769|SUPERIORITY|||||||0.82||||||Degrees of freedom=74.7|Mixed Models Analysis|||"We compared the change in the quality of life satisfaction over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in the quality of life satisfaction in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.82
74052771|NCT01453439|147657770|SUPERIORITY||Mean Difference (Net)|0.7937|STANDARD_ERROR_OF_MEAN|0.3007||0.0095|TWO_SIDED|||||Effect of interest: Treatment main effect, two-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment: F(num df=1, den df=112) = 5.17|Least Squares Means difference|Null hypothesis: There is no significant different in the perceived credibility of CBT and SPT.||||0.0095
74052772|NCT01453439|147657774|SUPERIORITY|||||||0.3||||||Degrees of freedom=88.0|Mixed Models Analysis|||"We compared the change in social functioning over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts, and slopes as random effects per person.~Null hypothesis: The rate of improvement in social functioning in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.30
74052773|NCT01453439|147657774|SUPERIORITY|||||||0.85||||||Degrees of freedom=74.5|Mixed Models Analysis|||"We compared the change in social functioning over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in social functioning CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.85
74052774|NCT01453439|147657775|SUPERIORITY||Mean Difference (Net)|1.5867|STANDARD_ERROR_OF_MEAN|0.6882||0.0235|TWO_SIDED|||||a priori significance level: 2-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment - F(num def=1,den df=79.9) = 15.55|Least Squares Means difference|Null hypothesis: There is no significant difference in treatment satisfaction between patients with BDD assigned to CBT vs. SPT.||||0.0235
74052775|NCT01453439|147657776|SUPERIORITY||Median Difference (Net)|9.439|STANDARD_ERROR_OF_MEAN|3.4259||0.0069|TWO_SIDED|||||a priori significance level: 2-sided alpha=0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment group, site, time (repeated)) effect of interest: main effect of treatment: F(num df=1, den df=110) = 7.59|Least Squares Mean difference|Null hypotheses: There is no significant difference in patient expectancy of improvement between BDD patients assigned to CBT vs. SPT.||||0.0069
74052776|NCT01014442|147657777|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|1.305||||0.2649|TWO_SIDED|95.0|-0.83|4.25|||Wilcoxon rank sum test|||Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.2500|-0.8300|0.2649
74052777|NCT01014442|147657777|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|11.405||||0.3113|TWO_SIDED|95.0|-10.2|42.78|||Wilcoxon rank sum test|||Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||42.7800|-10.2000|0.3113
74052778|NCT01014442|147657777|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.305||||0.2953|TWO_SIDED|95.0|-0.81|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.8100|0.2953
74052779|NCT01014442|147657778|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.29||||0.1308|TWO_SIDED|95.0|-2.99|0.41|||Wilcoxon rank sum test|||Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.4100|-2.9900|0.1308
74052780|NCT01014442|147657778|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-10.845||||0.4886|TWO_SIDED|95.0|-31.5|20.79|||Wilcoxon rank sum test|||Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||20.7900|-31.5000|0.4886
74052781|NCT01014442|147657778|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.2||||0.2218|TWO_SIDED|95.0|-0.6|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.6000|0.2218
74052782|NCT01014442|147657779|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.87||||0.0886|TWO_SIDED|95.0|-3.79|0.28|||Wilcoxon rank sum test|||Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2800|-3.7900|0.0886
74052783|NCT01014442|147657779|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-30.76||||0.022|TWO_SIDED|95.0|-54.97|-6.36|||Wilcoxon rank sum test|||Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-6.3600|-54.9700|0.0220
74052784|NCT01014442|147657779|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.56||||0.0008|TWO_SIDED|95.0|-1.02|-0.27|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.2700|-1.0200|0.0008
74052785|NCT01014442|147657780|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|3.945||||0.0318|TWO_SIDED|95.0|0.25|8.23|||Wilcoxon rank sum test|||Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.2300|0.2500|0.0318
74052786|NCT01014442|147657780|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-7.59||||0.7144|TWO_SIDED|95.0|-51.19|30.7|||Wilcoxon rank sum test|||Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.7000|-51.1900|0.7144
74052787|NCT01014442|147657780|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.27||||0.393|TWO_SIDED|95.0|-0.31|0.88|||Wilcoxon rank sum test|||Cmax of AcMPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.8800|-0.3100|0.3930
73888151|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|165.4|||<|0.0001|TWO_SIDED|95.0|105.6|225.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||225.3|105.6|<0.0001
74052788|NCT01014442|147657781|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|17.08||||0.3002|TWO_SIDED|95.0|-16.5|74.32|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||74.3200|-16.5000|0.3002
74052789|NCT01014442|147657782|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-25.24||||0.0334|TWO_SIDED|95.0|-53.25|-2.29|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-2.2900|-53.2500|0.0334
74052790|NCT01014442|147657783|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-23.805||||0.1151|TWO_SIDED|95.0|-52.27|5.97|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||5.9700|-52.2700|0.1151
74052791|NCT01014442|147657784|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-15.63||||0.5974|TWO_SIDED|95.0|-63.88|30.56|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.5600|-63.8800|0.5974
74052792|NCT01014442|147657785|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0005||||0.5466|TWO_SIDED|95.0|-0.00103|0.00259|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00259|-0.00103|0.5466
74052793|NCT01014442|147657785|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00728||||0.3223|TWO_SIDED|95.0|-0.00707|0.03161|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.03161|-0.00707|0.3223
74052794|NCT01014442|147657785|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00026||||0.2108|TWO_SIDED|95.0|-0.0007|0.00012|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00012|-0.00070|0.2108
74052795|NCT01014442|147657785|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0000112||||0.4334|TWO_SIDED|95.0|-0.000014|0.0000462|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called a Hodges-Lehmann estimator.||0.0000462|-0.0000140|0.4334
74052796|NCT01014442|147657786|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00081||||0.1511|TWO_SIDED|95.0|-0.00216|0.0003|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00030|-0.00216|0.1511
74052797|NCT01014442|147657786|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00695||||0.4131|TWO_SIDED|95.0|-0.0205|0.01103|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.01103|-0.02050|0.4131
74052798|NCT01014442|147657786|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00017||||0.2677|TWO_SIDED|95.0|-0.00046|0.00013|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00013|-0.00046|0.2677
74052799|NCT01014442|147657786|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000185||||0.0173|TWO_SIDED|95.0|-0.0000394|-0.000005|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0000050|-0.0000394|0.0173
74052800|NCT01014442|147657787|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00063||||0.3784|TWO_SIDED|95.0|-0.0023|0.00084|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00084|-0.00230|0.3784
74052801|NCT01014442|147657787|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.01602||||0.0942|TWO_SIDED|95.0|-0.03229|0.00297|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00297|-0.03229|0.0942
74052802|NCT01014442|147657787|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00037||||0.0032|TWO_SIDED|95.0|-0.00062|-0.00015|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00015|-0.00062|0.0032
74052803|NCT01014442|147657787|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000126||||0.176|TWO_SIDED|95.0|-0.0000328|-0.0000091|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0000091|-0.0000328|0.1760
74052804|NCT01014442|147657788|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0043||||0.0509|TWO_SIDED|95.0|-0.00027|0.00833|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00833|-0.00027|0.0509
74052805|NCT01014442|147657788|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00567||||0.8262|TWO_SIDED|95.0|-0.03414|0.02671|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.02671|-0.03414|0.8262
74052806|NCT01014442|147657788|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00023||||0.4345|TWO_SIDED|95.0|-0.0003|0.0007|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00070|-0.00030|0.4345
74052807|NCT01014442|147657788|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00001||||0.6472|TWO_SIDED|95.0|-0.0000586|0.0000364|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000364|-0.0000586|0.6472
74052808|NCT01014442|147657789|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0333||||0.5745|TWO_SIDED|95.0|-1.95|0.5|||Wilcoxon rank sum test|||Tmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5000|-1.9500|0.5745
74052809|NCT01014442|147657789|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.8||||0.2003|TWO_SIDED|95.0|-2.3333|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0833|-2.3333|0.2003
74052810|NCT01014442|147657789|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.5||||0.0929|TWO_SIDED|95.0|-2.0833|0.0|||Wilcoxon rank sum test|||Tmax of AcMPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.0833|0.0929
74052811|NCT01014442|147657789|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.0823|TWO_SIDED|95.0|0.0|0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0667|0.0000|0.0823
74052812|NCT01014442|147657790|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0417||||0.8106|TWO_SIDED|95.0|-0.5|1.7333|||Wilcoxon rank sum test|||Tmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.7333|-0.5000|0.8106
74052813|NCT01014442|147657790|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||1|TWO_SIDED|95.0|-0.1667|0.1667|||Wilcoxon rank sum test|||Tmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1667|-0.1667|1.0000
74052814|NCT01014442|147657790|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0667||||0.6311|TWO_SIDED|95.0|-0.3333|1.4667|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.4667|-0.3333|0.6311
74052815|NCT01014442|147657790|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.433|TWO_SIDED|95.0|-0.1667|0.0167|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0167|-0.1667|0.4330
74052816|NCT01014442|147657791|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||1|TWO_SIDED|95.0|-1.1667|0.5833|||Wilcoxon rank sum test|||Tmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5833|-1.1667|1.0000
74052817|NCT01014442|147657791|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0833||||0.4947|TWO_SIDED|95.0|-2.0|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0833|-2.0000|0.4947
74052818|NCT01014442|147657791|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1667||||0.4425|TWO_SIDED|95.0|-1.9667|0.2|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2000|-1.9667|0.4425
74052819|NCT01014442|147657791|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.972|TWO_SIDED|95.0|-0.05|0.0333|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0333|-0.0500|0.9720
74052820|NCT01014442|147657792|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0333||||0.8834|TWO_SIDED|95.0|-1.1667|0.7|||Wilcoxon rank sum test|||Tmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.7000|-1.1667|0.8834
74052821|NCT01014442|147657792|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.8333||||0.0386|TWO_SIDED|95.0|-2.2|0.0|||Wilcoxon rank sum test|||Tmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.2000|0.0386
74052822|NCT01014442|147657792|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.525||||0.0558|TWO_SIDED|95.0|-2.6167|0.0|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.6167|0.0558
74052823|NCT01014442|147657792|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.15||||0.0082|TWO_SIDED|95.0|-0.2333|-0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0667|-0.2333|0.0082
74052824|NCT01014442|147657793|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.13||||0.5224|TWO_SIDED|95.0|-0.26|0.5|||Wilcoxon rank sum test|||Cmin of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5000|-0.2600|0.5224
74052825|NCT01014442|147657793|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|11.16||||0.2088|TWO_SIDED|95.0|-5.29|30.29|||Wilcoxon rank sum test|||Cmin of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.2900|-5.2900|0.2088
74052826|NCT01014442|147657793|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.165||||0.1794|TWO_SIDED|95.0|-0.45|0.08|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0800|-0.4500|0.1794
74052827|NCT01014442|147657794|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.125||||0.4027|TWO_SIDED|95.0|-0.38|0.19|||Wilcoxon rank sum test|||Cmin of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.3800|0.4027
74052828|NCT01014442|147657794|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-16.09||||0.0875|TWO_SIDED|95.0|-29.35|6.39|||Wilcoxon rank sum test|||Cmin of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||6.3900|-29.3500|0.0875
74052829|NCT01014442|147657794|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.2||||0.0112|TWO_SIDED|95.0|-0.35|-0.05|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0500|-0.3500|0.0112
74052830|NCT01014442|147657795|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.215||||0.0818|TWO_SIDED|95.0|-0.56|0.05|||Wilcoxon rank sum test|||Cmin of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0500|-0.5600|0.0818
74052831|NCT01014442|147657795|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-14.03||||0.0945|TWO_SIDED|95.0|-26.9|2.94|||Wilcoxon rank sum test|||Cmin of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.9400|-26.9000|0.0945
74052832|NCT01014442|147657795|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.19||||0.0081|TWO_SIDED|95.0|-0.41|-0.04|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0400|-0.4100|0.0081
74052833|NCT01014442|147657796|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.36||||0.3289|TWO_SIDED|95.0|-1.14|0.28|||Wilcoxon rank sum test|||Cmin of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2800|-1.1400|0.3289
74052834|NCT01014442|147657796|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-20.3||||0.1243|TWO_SIDED|95.0|-49.39|4.71|||Wilcoxon rank sum test|||Cmin of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.7100|-49.3900|0.1243
74052835|NCT01014442|147657796|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.03||||0.8704|TWO_SIDED|95.0|-0.28|0.23|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2300|-0.2800|0.8704
74052836|NCT01014442|147657797|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|5.22||||0.4043|TWO_SIDED|95.0|-5.01|24.49|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||24.4900|-5.0100|0.4043
74052837|NCT01014442|147657798|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.44||||0.893|TWO_SIDED|95.0|-6.07|8.01|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.0100|-6.0700|0.8930
74052838|NCT01014442|147657799|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.935||||0.0819|TWO_SIDED|95.0|-14.31|1.11|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.1100|-14.3100|0.0819
74052839|NCT01014442|147657800|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-8.205||||0.0414|TWO_SIDED|95.0|-19.27|-0.07|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0700|-19.2700|0.0414
74052840|NCT01014442|147657801|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|69.7186||||0.1552|TWO_SIDED|95.0|-23.4659|162.9545|||Wilcoxon rank sum test|||Vz of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||162.9545|-23.4659|0.1552
74052841|NCT01014442|147657801|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.7836||||0.6057|TWO_SIDED|95.0|-3.2675|2.5529|||Wilcoxon rank sum test|||Vz of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.5529|-3.2675|0.6057
74052842|NCT01014442|147657801|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|299.1021||||0.0188|TWO_SIDED|95.0|79.5869|695.1789|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||695.1789|79.5869|0.0188
74052843|NCT01014442|147657802|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|88.959||||0.0659|TWO_SIDED|95.0|-5.7876|209.0183|||Wilcoxon rank sum test|||Vz of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||209.0183|-5.7876|0.0659
74052844|NCT01014442|147657802|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.4456||||0.7842|TWO_SIDED|95.0|-3.1366|2.292|||Wilcoxon rank sum test|||Vz of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.2920|-3.1366|0.7842
74099720|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.17||||0.174|TWO_SIDED|95.0|-0.41|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.07|-0.41|0.174
74099721|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.132|TWO_SIDED|95.0|-0.43|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.06|-0.43|0.132
74099722|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.18||||0.152|TWO_SIDED|95.0|-0.42|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.07|-0.42|0.152
74099723|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.23||||0.06|TWO_SIDED|95.0|-0.48|0.01||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||0.01|-0.48|0.060
73881568|NCT03192176|147297634|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|5.2||0.9481|TWO_SIDED|95.0|-10.59|9.92||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||9.92|-10.59|0.9481
74052845|NCT01014442|147657802|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|121.3737||||0.4072|TWO_SIDED|95.0|-233.6483|560.0069|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||560.0069|-233.6483|0.4072
74052846|NCT01014442|147657803|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|207.9933||||0.004|TWO_SIDED|95.0|71.2442|355.1739|||Wilcoxon rank sum test|||Vz of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||355.1739|71.2442|0.0040
74052847|NCT01014442|147657803|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|2.6186||||0.0689|TWO_SIDED|95.0|-0.1999|6.7766|||Wilcoxon rank sum test|||Vz of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||6.7766|-0.1999|0.0689
74052848|NCT01014442|147657803|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|635.7812||||0.0306|TWO_SIDED|95.0|49.4696|2793.7642|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2793.7642|49.4696|0.0306
73881569|NCT03192176|147297634|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|5.36||0.7246|TWO_SIDED|95.0|-12.46|8.68||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||8.68|-12.46|0.7246
74052849|NCT01014442|147657804|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|4.7477||||0.9029|TWO_SIDED|95.0|-73.5212|59.8304|||Wilcoxon rank sum test|||Vz of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||59.8304|-73.5212|0.9029
74052850|NCT01014442|147657804|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0077||||0.9692|TWO_SIDED|95.0|-3.6739|3.9521|||Wilcoxon rank sum test|||Vz of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.9521|-3.6739|0.9692
74052851|NCT01014442|147657804|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-149.7962||||0.3744|TWO_SIDED|95.0|-644.4526|311.9735|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||311.9735|-644.4526|0.3744
73881570|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.8|STANDARD_ERROR_OF_MEAN|5.45||0.8842|TWO_SIDED|95.0|-9.94|11.53||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||11.53|-9.94|0.8842
74052852|NCT01014442|147657805|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|7.8422||||0.1362|TWO_SIDED|95.0|-3.911|18.4444|||Wilcoxon rank sum test|||CL of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||18.4444|-3.9110|0.1362
74052853|NCT01014442|147657805|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1609||||0.4325|TWO_SIDED|95.0|-0.5693|0.271|||Wilcoxon rank sum test|||CL of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2710|-0.5693|0.4325
74052854|NCT01014442|147657805|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|47.2686||||0.0316|TWO_SIDED|95.0|4.197|112.7806|||Wilcoxon rank sum test|||CL of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||112.7806|4.1970|0.0316
74052855|NCT01014442|147657806|SUPERIORITY_OR_OTHER||Hodges-Lehmann estmator|19.0536||||0.0572|TWO_SIDED|95.0|-0.425|35.3852|||Wilcoxon rank sum test|||CL of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||35.3852|-0.4250|0.0572
74052856|NCT01014442|147657806|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.3541||||0.3198|TWO_SIDED|95.0|-0.2524|1.1097|||Wilcoxon rank sum test|||CL of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.1097|-0.2524|0.3198
73881571|NCT03192176|147297634|SUPERIORITY||LSMean difference|1.2|STANDARD_ERROR_OF_MEAN|5.05||0.8103|TWO_SIDED|95.0|-8.74|11.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||11.17|-8.74|0.8103
74052857|NCT01014442|147657806|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|54.0322||||0.0845|TWO_SIDED|95.0|-6.7706|160.3469|||Wilcoxon rank sum test|||CL of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||160.3469|-6.7706|0.0845
74052858|NCT01014442|147657807|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|25.0037||||0.0048|TWO_SIDED|95.0|8.2373|43.5102|||Wilcoxon rank sum test|||CL of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||43.5102|8.2373|0.0048
74052859|NCT01014442|147657807|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.4297||||0.0277|TWO_SIDED|95.0|0.034|0.9925|||Wilcoxon rank sum test|||CL of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.9925|0.0340|0.0277
74052860|NCT01014442|147657807|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|318.5455||||0.0002|TWO_SIDED|95.0|154.1902|526.1716|||Wilcoxon rank sum test|||CL of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||526.1716|154.1902|0.0002
74052861|NCT01014442|147657808|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.579||||0.9417|TWO_SIDED|95.0|-14.5052|11.6346|||Wilcoxon rank sum test|||CL of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||11.6346|-14.5052|0.9417
74052862|NCT01014442|147657808|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.1817||||0.2941|TWO_SIDED|95.0|-0.1954|0.6246|||Wilcoxon rank sum test|||CL of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.6246|-0.1954|0.2941
74052863|NCT01014442|147657808|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.9076||||0.817|TWO_SIDED|95.0|-84.8234|109.9321|||Wilcoxon rank sum test|||CL of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||109.9321|-84.8234|0.8170
74052864|NCT01014442|147657809|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-2.4102||||0.2798|TWO_SIDED|95.0|-8.5642|3.0044|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.0044|-8.5642|0.2798
74052865|NCT01014442|147657809|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|72.7203||||0.4063|TWO_SIDED|95.0|-107.1596|393.5295|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||393.5295|-107.1596|0.4063
74052866|NCT01014442|147657809|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-3.6042||||0.0441|TWO_SIDED|95.0|-8.1854|-0.1887|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.1887|-8.1854|0.0441
74052867|NCT01014442|147657810|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-5.8077||||0.051|TWO_SIDED|95.0|-11.7302|0.0033|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0033|-11.7302|0.0510
74052868|NCT01014442|147657810|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-171.159||||0.2733|TWO_SIDED|95.0|-361.4437|171.9652|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||171.9652|-361.4437|0.2733
74052869|NCT01014442|147657810|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.9621||||0.0718|TWO_SIDED|95.0|-4.8456|0.2067|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2067|-4.8456|0.0718
74052870|NCT01014442|147657811|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-8.6964||||0.0002|TWO_SIDED|95.0|-13.7713|-4.6498|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-4.6498|-13.7713|0.0002
74052871|NCT01014442|147657811|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-268.9537||||0.0058|TWO_SIDED|95.0|-506.7782|-77.397|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-77.3970|-506.7782|0.0058
74052872|NCT01014442|147657811|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.828|||<|0.0001|TWO_SIDED|95.0|-7.1455|-2.6133|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-2.6133|-7.1455|<0.0001
74052873|NCT01014442|147657812|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|1.7477||||0.7144|TWO_SIDED|95.0|-12.101|14.6563|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||14.6563|-12.1010|0.7144
74052874|NCT01014442|147657812|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-156.3255||||0.3413|TWO_SIDED|95.0|-526.0765|195.8348|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||195.8348|-526.0765|0.3413
74052875|NCT01014442|147657812|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.888||||0.6251|TWO_SIDED|95.0|-3.0288|4.2273|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.2273|-3.0288|0.6251
74052876|NCT01014442|147657813|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|24.315||||0.2342|TWO_SIDED|95.0|-16.0292|79.365|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||79.3650|-16.0292|0.2342
74052877|NCT01014442|147657814|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-13.5592||||0.1964|TWO_SIDED|95.0|-37.395|5.4825|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||5.4825|-37.3950|0.1964
74099724|NCT00261443|147748800|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.085|TWO_SIDED|95.0|-0.46|0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.03|-0.46|0.085
74099725|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.774|TWO_SIDED|95.0|-0.25|0.33||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.33|-0.25|0.774
74099726|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.213|TWO_SIDED|95.0|-0.49|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.11|-0.49|0.213
74099727|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.465|TWO_SIDED|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.20|-0.43|0.465
74099728|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.068|TWO_SIDED|95.0|-0.59|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.02|-0.59|0.068
74099729|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.27||||0.095|TWO_SIDED|95.0|-0.58|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.05|-0.58|0.095
74099730|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.082|TWO_SIDED|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.04|-0.62|0.082
74099731|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.36||||0.033|TWO_SIDED|95.0|-0.69|-0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.03|-0.69|0.033
74099732|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.062|TWO_SIDED|95.0|-0.64|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.02|-0.64|0.062
74099733|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.43||||0.011|TWO_SIDED|95.0|-0.76|-0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.10|-0.76|0.011
74099734|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.37||||0.027|TWO_SIDED|95.0|-0.7|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.04|-0.70|0.027
74099735|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.37||||0.029|TWO_SIDED|95.0|-0.71|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.04|-0.71|0.029
74099736|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.4||||0.022|TWO_SIDED|95.0|-0.74|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.06|-0.74|0.022
74099737|NCT00261443|147748803|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.4||||0.023|TWO_SIDED|95.0|-0.75|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.06|-0.75|0.023
74052878|NCT01014442|147657815|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-22.7878||||0.0672|TWO_SIDED|95.0|-44.8217|3.7573|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.7573|-44.8217|0.0672
74052879|NCT01014442|147657816|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-21.4737||||0.2453|TWO_SIDED|95.0|-64.1567|8.5708|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.5708|-64.1567|0.2453
73881572|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|5.1||0.9631|TWO_SIDED|95.0|-9.81|10.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||10.28|-9.81|0.9631
73888152|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|97.9||||0.0015|TWO_SIDED|95.0|38.3|157.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||157.6|38.3|0.0015
74052880|NCT01014442|147657817|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00237||||0.1362|TWO_SIDED|95.0|-0.00734|0.00106|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00106|-0.00734|0.1362
74052881|NCT01014442|147657817|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.04797||||0.4325|TWO_SIDED|95.0|-0.08467|0.26322|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.26322|-0.08467|0.4325
74052882|NCT01014442|147657817|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00311||||0.0316|TWO_SIDED|95.0|-0.00645|-0.00029|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00029|-0.00645|0.0316
74052883|NCT01014442|147657817|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0000158||||0.3269|TWO_SIDED|95.0|-0.0000134|0.0000552|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000552|-0.0000134|0.3269
74052884|NCT01014442|147657818|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00383||||0.0572|TWO_SIDED|95.0|-0.00761|0.0001|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00010|-0.00761|0.0572
74052885|NCT01014442|147657818|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.09626||||0.3198|TWO_SIDED|95.0|-0.25269|0.11464|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.11464|-0.25269|0.3198
74052886|NCT01014442|147657818|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00131||||0.0845|TWO_SIDED|95.0|-0.00352|0.00013|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00013|-0.00352|0.0845
74052887|NCT01014442|147657818|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00001||||0.1769|TWO_SIDED|95.0|-0.000025|0.0000043|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000043|-0.0000250|0.1769
74052888|NCT01014442|147657819|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0049||||0.0048|TWO_SIDED|95.0|-0.00876|-0.00148|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00148|-0.00876|0.0048
74052889|NCT01014442|147657819|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.14764||||0.0277|TWO_SIDED|95.0|-0.31026|-0.01067|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.01067|-0.31026|0.0277
74052890|NCT01014442|147657819|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0035||||0.0002|TWO_SIDED|95.0|-0.00476|0.00168|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00168|-0.00476|0.0002
74052891|NCT01014442|147657819|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000138||||0.1661|TWO_SIDED|95.0|-0.0000295|0.0000047|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000047|-0.0000295|0.1661
74052892|NCT01014442|147657820|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00054||||0.9417|TWO_SIDED|95.0|-0.01037|0.01042|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.01042|-0.01037|0.9417
74052893|NCT01014442|147657820|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1461||||0.2941|TWO_SIDED|95.0|-0.39951|0.12988|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.12988|-0.39951|0.2941
74052894|NCT01014442|147657820|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00033||||0.817|TWO_SIDED|95.0|-0.00361|0.00421|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00421|-0.00361|0.8170
74052895|NCT01014442|147657820|SUPERIORITY_OR_OTHER||Hodge-Lehmann estimator|-0.0000239||||0.1927|TWO_SIDED|95.0|-0.0000594|0.0000154|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000154|-0.0000594|0.1927
74052896|NCT01014442|147657821|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.1616||||0.0821|TWO_SIDED|95.0|-0.0121|0.4188|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.4188|-0.0121|0.0821
74052897|NCT01014442|147657822|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0427||||0.3628|TWO_SIDED|95.0|-0.0455|0.1221|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1221|-0.0455|0.3628
74099738|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.09||||0.486|TWO_SIDED|95.0|-0.17|0.36||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.36|-0.17|0.486
74099739|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.04||||0.793|TWO_SIDED|95.0|-0.3|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.23|-0.30|0.793
74099740|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.06||||0.665|TWO_SIDED|95.0|-0.34|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.22|-0.34|0.665
74099741|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.65|TWO_SIDED|95.0|-0.35|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.22|-0.35|0.650
74099742|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.06||||0.705|TWO_SIDED|95.0|-0.34|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.23|-0.34|0.705
74099743|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.08||||0.572|TWO_SIDED|95.0|-0.38|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.21|-0.38|0.572
74099744|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.418|TWO_SIDED|95.0|-0.43|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.18|-0.43|0.418
74052898|NCT01014442|147657823|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.001||||0.9873|TWO_SIDED|95.0|-0.1152|0.1173|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1173|-0.1152|0.9873
74052899|NCT01014442|147657824|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0857||||0.2178|TWO_SIDED|95.0|-0.187|0.0265|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0265|-0.1870|0.2178
74052900|NCT01014442|147657830|SUPERIORITY_OR_OTHER||Difference in rates|-1.8||||1|TWO_SIDED|95.0|-24.9|22.1|||Fisher Exact|||||22.1|-24.9|1.0000
74052901|NCT00089505|147657876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.69|||<|0.001|TWO_SIDED|95.0|1.79|7.61||P-value was not adjusted for multiple interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Regression, Cox|The model was stratified by screening CD4 strata (\<50 vs. \>=50 cells/mm\^3).|The HR is for NVP/NVP vs. NVP/LPV\_r.|||7.61|1.79|<0.001
73881573|NCT03192176|147297634|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|4.87||0.9788|TWO_SIDED|95.0|-9.73|9.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||9.47|-9.73|0.9788
73881574|NCT03192176|147297634|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|5.02||0.7875|TWO_SIDED|95.0|-11.26|8.54||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||8.54|-11.26|0.7875
74052902|NCT00089505|147657877|NON_INFERIORITY_OR_EQUIVALENCE|NoNVP/NVP regimen will be considered equivalent to the NoNVP/LPV\_r regimen if the two-sided 95% confidence interval for the hazard ratio for virologi falure is entirely below 2.0; equivalence will be established if the same confidence interval is entirely within the range 0.5 to 2.0.|Hazard Ratio (HR)|0.85||||0.43|TWO_SIDED|95.0|0.56|1.29||P-value is for a test of superiority and was not adjusted for interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used.|Regression, Cox|The cox proportional hazard model was stratified by screening CD4 strata (\<50 vs. \>=50 cells/mm3).|The HR is for NoNVP/NVP vs. NoNVP/LPV\_r.|||1.29|0.56|0.43
74052903|NCT04542525|147657880|SUPERIORITY||||||<|0.0001|||||||Exact Test of Binomial Proportion||||P-value is provided from exact test of binomial proportion (one-sided alpha = 2.5%) comparing PanOptix Toric Trifocal IOL Model TFNT20 with historical threshold 29.2 % (rate calculated for a non-toric IOL in Japanese study patients that would qualify for a T2 lens using the same toric calculator).|||<0.0001
74052904|NCT02625610|147657894|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.1779|TWO_SIDED|95.0|0.74|1.11|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||1.11|0.74|0.1779
74052905|NCT02625610|147657895|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.85|1.28||||||||1.28|0.85|
74052906|NCT02625610|147657897|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.55|1.51||||||||1.51|0.55|
74099745|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.2||||0.185|TWO_SIDED|95.0|-0.51|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.10|-0.51|0.185
73881575|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|5.08||0.9746|TWO_SIDED|95.0|-9.85|10.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.17|-9.85|0.9746
73881576|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|5.21||0.9092|TWO_SIDED|95.0|-9.67|10.86||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.86|-9.67|0.9092
74052907|NCT01624974|147657942|SUPERIORITY||Difference in Least Squares (LS) Means|0.047||||0.282|TWO_SIDED|95.0|-0.039|0.134|||LDA model|The LDA model assumes that repeated measurements follow a multivariate normal distribution.||||0.134|-0.039|0.282
74052908|NCT01468844|147657968|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|15.3|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052909|NCT01468844|147657969|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052910|NCT01468844|147657970|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 24 compared to baseline is reported|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052911|NCT01468844|147657971|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 12 is reported.|Mean Difference (Net)|-5.0|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052912|NCT01468844|147657972|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 24 is reported.|Mean Difference (Net)|-8.2|STANDARD_DEVIATION|4.4|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052913|NCT01468844|147657973|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 3 compared to baseline is reported.|Mean Difference (Net)|-2.5|STANDARD_DEVIATION|1.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052914|NCT01468844|147657974|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|3.5|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052915|NCT01468844|147657975|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.2|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052916|NCT01468844|147657976|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-5.4|STANDARD_DEVIATION|2.8|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052917|NCT01468844|147657977|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-5.4|STANDARD_DEVIATION|3.8|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052918|NCT01468844|147657978|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|30.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052919|NCT01468844|147657979|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|39.3|STANDARD_DEVIATION|113.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052920|NCT01468844|147657980|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|313.2|STANDARD_DEVIATION|267.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052921|NCT01468844|147657981|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|428.5|STANDARD_DEVIATION|146.2|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052922|NCT01468844|147657982|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|119.0|STANDARD_DEVIATION|66.6|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74099746|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.1||||0.536|TWO_SIDED|95.0|-0.41|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.21|-0.41|0.536
74099747|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.637|TWO_SIDED|95.0|-0.39|0.24||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.24|-0.39|0.637
73888153|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|138.4|||<|0.0001|TWO_SIDED|95.0|78.7|198.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||198.2|78.7|<0.0001
74052923|NCT01468844|147657983|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052924|NCT01468844|147657983|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|-1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052925|NCT01468844|147657983|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052926|NCT01468844|147657984|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052927|NCT01468844|147657984|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052928|NCT01468844|147657984|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
74052929|NCT02417935|147658003|NON_INFERIORITY|If the upper bound of the 95% CI does not exceed 0.51 (pre-defined non-inferiority margin), it will be concluded that duloxetine is not inferior to Pregabalin.|Mean Difference (Final Values)|0.072||||0.7|TWO_SIDED|95.0|-0.295|0.439|||Mixed Models Analysis|||||0.439|-0.295|0.700
74052930|NCT02417935|147658004|OTHER||Mean Difference (Final Values)|-0.2||||0.149|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|0.149
74052931|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|0.1||||0.535|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||Worst Pain||0.6|-0.3|.535
74052932|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|-0.1||||0.436|TWO_SIDED|95.0|-0.5|0.2|||Mixed Models Analysis|||Least Pain||0.2|-0.5|.436
74052933|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|0.1||||0.534|TWO_SIDED|95.0|-0.2|0.5|||Mixed Models Analysis|||Average Pain||0.5|-0.2|.534
74052934|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|0.0||||0.948|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|||Pain Right Now||0.4|-0.4|.948
74052935|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|-0.2||||0.225|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||General Activity||0.1|-0.6|.225
74052936|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|-0.2||||0.276|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||Mood||0.2|-0.6|.276
74052937|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|-0.1||||0.507|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Walking Ability||0.2|-0.4|.507
74052938|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|-0.2||||0.216|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||Normal Work||0.1|-0.5|.216
74052939|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|-0.2||||0.233|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||Relations with other people||0.1|-0.4|.233
73881577|NCT03192176|147297634|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|5.27||0.9745|TWO_SIDED|95.0|-10.55|10.21||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.21|-10.55|0.9745
74052940|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|0.0||||0.857|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Sleep||0.3|-0.3|.857
74052941|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|-0.2||||0.133|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||Enjoyment of life||0.1|-0.5|.133
74052942|NCT02417935|147658005|OTHER||Mean Difference (Final Values)|-0.16||||0.246|TWO_SIDED|95.0|-0.44|0.11|||Mixed Models Analysis|||Average Interference Score||0.11|-0.44|.246
74052943|NCT02417935|147658006|OTHER||Mean Difference (Final Values)|-0.7||||0.627|TWO_SIDED|95.0|-3.6|2.2|||ANCOVA|||Total Score||2.2|-3.6|.627
74052944|NCT02417935|147658006|OTHER||Mean Difference (Final Values)|-0.2||||0.355|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Burning Pain||0.2|-0.6|.355
74052945|NCT02417935|147658006|OTHER||Mean Difference (Final Values)|0.1||||0.731|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Pressing Pain||0.4|-0.3|.731
74099748|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.03||||0.875|TWO_SIDED|95.0|-0.34|0.29||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.29|-0.34|0.875
73888154|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|241.3|||<|0.0001|TWO_SIDED|95.0|162.8|319.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||319.9|162.8|<0.0001
74052946|NCT02417935|147658006|OTHER||Mean Difference (Final Values)|0.1||||0.721|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Paroxysmal Pain||0.4|-0.3|.721
74052947|NCT02417935|147658006|OTHER||Mean Difference (Final Values)|-0.2||||0.345|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Evoked Pain||0.2|-0.5|.345
74052948|NCT02417935|147658006|OTHER||Mean Difference (Final Values)|-0.1||||0.557|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Paresthesia/Dysesthesia||0.3|-0.5|.557
74052949|NCT02417935|147658007|OTHER||Mean Difference (Final Values)|-0.2||||0.106|TWO_SIDED|95.0|-0.4|0.0|||Mixed Models Analysis|||||0.0|-0.4|.106
74052950|NCT02417935|147658008|OTHER||Mean Difference (Final Values)|0.014||||0.361|TWO_SIDED|95.0|-0.0161|0.0441|||ANCOVA|||||0.0441|-0.0161|.361
74052951|NCT02417935|147658009|OTHER||Mean Difference (Final Values)|0.2||||0.701|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|.701
74052952|NCT02417935|147658010|OTHER||Mean Difference (Final Values)|0.005||||0.976|TWO_SIDED|95.0|-0.355|0.366|||Mixed Models Analysis|||||0.366|-0.355|.976
74052953|NCT02417935|147658011|OTHER||Mean Difference (Final Values)|0.136||||0.503|TWO_SIDED|95.0|-0.264|0.537|||Mixed Models Analysis|||||0.537|-0.264|.503
74052954|NCT02417935|147658012|OTHER|||||||0.632||||||30% reduction|Fisher Exact|||||||.632
74052955|NCT02417935|147658012|OTHER|||||||0.907|||||||Fisher Exact|||50% Reduction||||.907
74052956|NCT01408862|147658014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by Wilcoxon-paired test. Variable will be log-transformed if they were not normally distributed. . We used the CSS/ Statistica program package, StatSoft V 6.0.~This analysis applies to both GLP1R and GIPR categories"||||0.04
74052957|NCT01408862|147658015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.2|||||||ANOVA|||Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by two-way ANOVA with repeated measures on one factor, for variables measured in several consecutive times. Variable will be log-transformed if they were not normally distributed. Wilcoxon test for paired samples was used. The Statistica program package (StatSoft V 6.0) were used to perform these analyses, which applied to both GLP1R and GIPR agonist effect categories.||||0.20
74052958|NCT01813149|147658017|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|df=20 t-statistic = 2.90||A t-test to see if expression of α1-AR differs between phenylephrine responders and non-responders||||0.009
74052959|NCT01882439|147658036|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.95|STANDARD_ERROR_OF_MEAN|5.73|<|0.0001|TWO_SIDED|95.0|14.72|37.19|||Large sample approximation|Missing response (MR) = non-response (NR)||||37.19|14.72|<0.0001
74052960|NCT01882439|147658036|SUPERIORITY_OR_OTHER||Risk Difference (RD)|23.31|STANDARD_ERROR_OF_MEAN|5.71|<|0.0001|TWO_SIDED|95.0|12.1|34.51|||Large sample approximation|MR=NR||||34.51|12.10|<0.0001
74052961|NCT01882439|147658037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2529|STANDARD_ERROR_OF_MEAN|0.06422|<|0.0001|TWO_SIDED|95.0|-0.3792|-0.1266|||Mixed Models Analysis|No imputation||||-0.1266|-0.3792|<0.0001
74052962|NCT01882439|147658037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.215|STANDARD_ERROR_OF_MEAN|0.06453||0.0009|TWO_SIDED|95.0|-0.3419|-0.0881|||Mixed Models Analysis|No imputation||||-0.0881|-0.3419|0.0009
74052963|NCT01997333|147658075|SUPERIORITY|||||||0.761|||||||Log Rank|Stratified log rank test.||||||0.761
74052964|NCT01997333|147658076|SUPERIORITY|||||||0.264|||||||Cochran-Mantel-Haenszel|Adjusted for stratification factors.||||||0.264
74052965|NCT01997333|147658078|SUPERIORITY|||||||0.726|||||||Log Rank|Stratified log rank.||||||0.726
74052966|NCT02269709|147658081|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline and Follow-up #1||||<0.0001
74052967|NCT02269709|147658081|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow up #2||||<0.0001
74052968|NCT02269709|147658081|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow-up #3||||<0.0001
74099749|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.378|TWO_SIDED|95.0|-0.46|0.17||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||0.17|-0.46|0.378
74099750|NCT00261443|147748805|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.474|TWO_SIDED|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.20|-0.43|0.474
74099751|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.1||||0.488|TWO_SIDED|95.0|-0.19|0.4||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.40|-0.19|0.488
74099752|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.15||||0.349|TWO_SIDED|95.0|-0.46|0.16||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.16|-0.46|0.349
74099753|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.653|TWO_SIDED|95.0|-0.39|0.25||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.25|-0.39|0.653
74099754|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.24||||0.141|TWO_SIDED|95.0|-0.56|0.08||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.08|-0.56|0.141
74052969|NCT02269709|147658082|OTHER|Mean IVC pressures from different time points were compared using the Wilcoxon signed-rank test.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74052970|NCT04411472|147658085|SUPERIORITY||Odds Ratio (OR)|1.18||||0.8025|TWO_SIDED|95.0|0.805|1.732|||One-sided p-value|||||1.732|0.805|0.8025
74099755|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.196|TWO_SIDED|95.0|-0.54|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.11|-0.54|0.196
74099756|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.088|TWO_SIDED|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.04|-0.62|0.088
74099757|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.34||||0.047|TWO_SIDED|95.0|-0.68|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.01|-0.68|0.047
74099758|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.057|TWO_SIDED|95.0|-0.67|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.01|-0.67|0.057
74052971|NCT04411472|147658086|SUPERIORITY||Odds Ratio (OR)|0.54||||0.1824|TWO_SIDED|95.0|0.139|2.131|||One-sided p-value|||||2.131|0.139|0.1824
74052972|NCT04411472|147658087|SUPERIORITY||Odds Ratio (OR)|0.02||||0.008|TWO_SIDED|95.0|0.001|0.405|||One-sided p-value|||||0.405|0.001|0.0080
74052973|NCT04411472|147658088|SUPERIORITY||Odds Ratio (OR)|0.94||||0.3894|TWO_SIDED|95.0|0.606|1.454|||One-sided p-value|||||1.454|0.606|0.3894
74052974|NCT04411472|147658089|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1237|TWO_SIDED|95.0|0.128|1.697|||One-sided p-value|||||1.697|0.128|0.1237
74052975|NCT04411472|147658091|SUPERIORITY||z-score statistic difference proportions|-7.9||||0.019|TWO_SIDED|95.0|-15.4|-0.4||one-sided p-value based on the z-score statistic for the difference in proportions|one-sided p-value|||||-0.4|-15.4|0.019
74052976|NCT04411472|147658092|SUPERIORITY|||||||0.546|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through to Day 28||||0.5460
74052977|NCT04411472|147658092|SUPERIORITY|||||||0.677|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.6770
74052978|NCT04411472|147658092|SUPERIORITY|||||||0.993|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.9930
74052979|NCT04411472|147658092|SUPERIORITY|||||||0.779|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.7790
74052980|NCT04411472|147658093|SUPERIORITY|||||||0.051|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through Day 28||||0.0510
74052981|NCT04411472|147658093|SUPERIORITY|||||||0.013|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.0130
74099759|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.063|TWO_SIDED|95.0|-0.68|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.02|-0.68|0.063
74052982|NCT04411472|147658093|SUPERIORITY|||||||0.025|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.0250
74052983|NCT04411472|147658093|SUPERIORITY|||||||0.073|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.0730
74052984|NCT04411472|147658094|SUPERIORITY|||||||1|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through Day 28||||1.0000
73888155|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|121.1||||0.0028|TWO_SIDED|95.0|42.4|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.9|42.4|0.0028
74019444|NCT02804763|147591171|SUPERIORITY||Difference vs PBO|11.6|||||TWO_SIDED|95.0|-9.2|32.4||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 1 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||32.4|-9.2|
74019445|NCT02804763|147591171|SUPERIORITY||Difference vs PBO|17.3|||||TWO_SIDED|95.0|-3.3|38.0||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 2 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||38.0|-3.3|
74019446|NCT02804763|147591171|SUPERIORITY||Difference vs PBO|15.0|||||TWO_SIDED|95.0|-5.5|35.4||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 3 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||35.4|-5.5|
74052985|NCT04411472|147658094|SUPERIORITY|||||||0.979|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.9790
74052986|NCT04411472|147658094|SUPERIORITY|||||||0.675|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.6750
74052987|NCT04411472|147658094|SUPERIORITY|||||||0.031|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.0310
74052988|NCT04411472|147658095|SUPERIORITY|||||||0.545|||||||One-sided p-value from re-randomization|||||||0.5450
74052989|NCT04411472|147658096|SUPERIORITY|||||||0.081|||||||One-sided p-value from re-randomization|||||||0.0810
74052990|NCT04411472|147658097|SUPERIORITY|||||||0.979|||||||One-sided p-value from re-randomization|||||||0.9790
74052991|NCT04411472|147658098|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6916|TWO_SIDED|95.0|0.806|1.437|||One-sided p-value|||||1.437|0.806|0.6916
74052992|NCT04411472|147658099|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.0628|TWO_SIDED|95.0|0.18|1.234|||One-sided p-value|||||1.234|0.180|0.0628
74052993|NCT04411472|147658100|SUPERIORITY||Hazard Ratio (HR)|0.01|||<|0.0001|TWO_SIDED|95.0|0.001|0.054|||One-sided p-value|||||0.054|0.001|<0.0001
74052994|NCT00362297|147658110|SUPERIORITY_OR_OTHER_LEGACY||Incident Risk Ratio|0.79||||0.052||95.0|0.63|1.0|||Regression, Poisson|Adjusted for period effects.||Comparison of genital HSV shedding rate on high dose acyclovir to standard dose valacyclovir. Powered with 80% chance of detecting 50% reduction in genital shedding rate on high dose acyclovir compared to standard dose valacyclovir.||1.00|0.63|0.052
74052995|NCT03702166|147658112|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|Multiple t-tests with Bonferroni corrections for multiple comparisons||||||0.01
74052996|NCT03702166|147658114|SUPERIORITY|||||||0.038|||||||t-test, 1 sided|Multiple t-tests, with Bonferroni corrections for multiple comparisons,||||||0.038
74052997|NCT03702166|147658116|SUPERIORITY|||||||0.031||||||Multiple t-tests, with Bonferroni corrections for multiple comparisons|t-test, 1 sided|||||||0.031
74052998|NCT00684073|147658118|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.42||||0.13||95.0||||p-value adjusted for treatment only|ANCOVA||Difference between treatments (Suboxone minus Subutex)estimated by ANCOVA = 0.42.|||||0.130
74052999|NCT01657903|147658119|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|41.15|||<|0.0001|TWO_SIDED|95.0|34.42|47.89||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||47.89|34.42|<0.0001
74053000|NCT01657903|147658119|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|41.28|||<|0.0001|TWO_SIDED|95.0|34.51|48.06||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||48.06|34.51|<0.0001
74053001|NCT01657903|147658119|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|40.83|||<|0.0001|TWO_SIDED|95.0|34.06|47.61||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||47.61|34.06|<0.0001
74053002|NCT01657903|147658120|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.36|||<|0.0001|TWO_SIDED|95.0|6.01|12.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||12.72|6.01|<0.0001
74099760|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.3||||0.091|TWO_SIDED|95.0|-0.65|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.05|-0.65|0.091
74099761|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.105|TWO_SIDED|95.0|-0.64|0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.06|-0.64|0.105
74099762|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.36||||0.047|TWO_SIDED|95.0|-0.72|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.01|-0.72|0.047
74099763|NCT00261443|147748807|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.073|TWO_SIDED|95.0|-0.69|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.03|-0.69|0.073
74099764|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.0||||0.91|TWO_SIDED|95.0|0.92|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 4||1.08|0.92|0.910
74099765|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.04||||0.3|TWO_SIDED|95.0|0.97|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 8||1.11|0.97|0.300
74053003|NCT01657903|147658120|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.45|||<|0.0001|TWO_SIDED|95.0|6.07|12.82||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||12.82|6.07|<0.0001
74053004|NCT01657903|147658120|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.66|||<|0.0001|TWO_SIDED|95.0|8.28|15.03||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.03|8.28|<0.0001
74053005|NCT01259388|147658127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.346|||||||t-test, 2 sided|||||||0.346
74053006|NCT01259388|147658129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
74053007|NCT02743494|147658137|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0003|TWO_SIDED|96.4|0.56|0.86|||Stratified log-rank test||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Placebo.|||0.86|0.56|0.0003
74053008|NCT02155725|147658162|SUPERIORITY||Odds Ratio (OR)|0.9889||||0.9563|TWO_SIDED|95.0|0.6633|1.4744|||Regression, Logistic|||||1.4744|0.6633|0.9563
74099766|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.01||||0.744|TWO_SIDED|95.0|0.95|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 12||1.08|0.95|0.744
74099767|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.09||||0.015|TWO_SIDED|95.0|1.02|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 16||1.17|1.02|0.015
74099768|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.264|TWO_SIDED|95.0|0.97|1.14||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 20||1.14|0.97|0.264
74053009|NCT02155725|147658163|SUPERIORITY||Odds Ratio (OR)|1.0064||||0.9786|TWO_SIDED|95.0|0.6321|1.6022|||Regression, Logistic|||Failure on individual component of the primary endpoint defined as administration of 2 units of RBCs.||1.6022|0.6321|0.9786
74053010|NCT02155725|147658164|SUPERIORITY||Odds Ratio (OR)|1.0169||||0.9474|TWO_SIDED|95.0|0.6177|1.6741|||Regression, Logistic|||Failure on individual component of the primary endpoint defined as a loss of at least 4 g/dL of Hb.||1.6741|0.6177|0.9474
74053011|NCT03091920|147658179|OTHER|No statistical testing was performed.|LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-14.2|12.4|||||LS mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1 postdose AM 1 hour||12.4|-14.2|
74053012|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|0.6|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-11.8|12.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 1 hour||12.9|-11.8|
74053013|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-13.9|STANDARD_ERROR_OF_MEAN|8.1|||TWO_SIDED|95.0|-30.6|2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 4 hour||2.8|-30.6|
74053014|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-15.5|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-31.0|0.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 4 hour||0|-31.0|
74053015|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-9.9|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-23.8|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 8 hour||3.9|-23.8|
74053016|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-16.0|9.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 8 hour||9.7|-16.0|
74053017|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-8.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-26.2|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 predose PM||8.6|-26.2|
74053018|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-19.7|12.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 predose PM||12.6|-19.7|
74053019|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-18.7|12.2||||||Day 1 postdose PM 1 hour||12.2|-18.7|
74053020|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-4.4|STANDARD_ERROR_OF_MEAN|6.9|||TWO_SIDED|95.0|-18.7|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose PM||9.9|-18.7|
74053021|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-18.2|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose AM||1.3|-18.2|
74053022|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-14.8|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose AM||3.3|-14.8|
74053023|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-15.4|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-28.1|-2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 1 hour||-2.8|-28.1|
74053024|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-9.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-21.1|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 1 hour||2.3|-21.1|
74053025|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-8.8|STANDARD_ERROR_OF_MEAN|8.1|||TWO_SIDED|95.0|-25.6|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 4 hour||7.9|-25.6|
74053026|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-11.2|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-26.7|4.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 4 hour||4.4|-26.7|
74053027|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-24.0|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose PM||0.6|-24.0|
74053028|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-7.0|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-18.4|4.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose PM||4.4|-18.4|
74053029|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|1.6|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-13.0|16.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 1 hour||16.2|-13.0|
74053030|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|95.0|-12.9|14.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 1 hour||14.2|-12.9|
73881578|NCT03192176|147297634|SUPERIORITY||LSMean difference|4.7|STANDARD_ERROR_OF_MEAN|4.95||0.3458|TWO_SIDED|95.0|-5.08|14.44||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||14.44|-5.08|0.3458
74053031|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-16.4|7.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 4 hour||7.1|-16.4|
74053032|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-3.0|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-13.9|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 4 hour||7.9|-13.9|
74053033|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-15.8|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 predose AM||6.4|-15.8|
74053034|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-16.0|4.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 predose AM||4.5|-16.0|
74053035|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-13.6|13.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 postdose PM 4 hour||13.1|-13.6|
74053036|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-2.8|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-15.2|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 postdose PM 4 hour||9.6|-15.2|
74099769|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.09|TWO_SIDED|95.0|0.99|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 24||1.11|0.99|0.090
74099770|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.08||||0.056|TWO_SIDED|95.0|1.0|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 28||1.17|1.00|0.056
74053037|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-15.5|3.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4 predose AM||3.0|-15.5|
74053038|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-8.1|STANDARD_ERROR_OF_MEAN|4.1|||TWO_SIDED|95.0|-16.6|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4 predose AM||0.5|-16.6|
74053039|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-1.7|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-11.8|8.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5 predose AM||8.4|-11.8|
74053040|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-10.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-19.4|-0.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5 predose AM||-0.7|-19.4|
74053041|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-6.7|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-18.1|4.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6 predose AM||4.7|-18.1|
74053042|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-14.8|6.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6 predose AM||6.3|-14.8|
74099771|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|0.99||||0.756|TWO_SIDED|95.0|0.93|1.05||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 32||1.05|0.93|0.756
73881579|NCT03192176|147297634|SUPERIORITY||LSMean differnce|3.6|STANDARD_ERROR_OF_MEAN|4.98||0.4657|TWO_SIDED|95.0|-6.17|13.45||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||13.45|-6.17|0.4657
74053043|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-12.2|14.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 predose AM||14.1|-12.2|
74053044|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-16.0|8.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 predose AM||8.4|-16.0|
74053045|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-3.0|STANDARD_ERROR_OF_MEAN|5.8|||TWO_SIDED|95.0|-15.1|9.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 1 hour||9.1|-15.1|
74099772|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.177|TWO_SIDED|95.0|0.98|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 36||1.13|0.98|0.177
74099773|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.07||||0.021|TWO_SIDED|95.0|1.01|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 40||1.13|1.01|0.021
74099774|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.06||||0.216|TWO_SIDED|95.0|0.96|1.16||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 44||1.16|0.96|0.216
74099775|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.07||||0.017|TWO_SIDED|95.0|1.01|1.15||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 48||1.15|1.01|0.017
74053046|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-6.4|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-17.6|4.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 1 hour||4.8|-17.6|
74053047|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-9.5|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-22.7|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 4 hour||3.7|-22.7|
74053048|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-17.2|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-29.5|-5.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 4 hour||-5.0|-29.5|
74053049|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-24.4|1.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose AM||1.1|-24.4|
74053050|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-20.2|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose AM||3.5|-20.2|
74053051|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-13.4|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-28.1|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 1 hour||1.4|-28.1|
74053052|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-10.3|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-24.0|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 1 hour||3.3|-24.0|
74053053|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-10.1|STANDARD_ERROR_OF_MEAN|8.2|||TWO_SIDED|95.0|-27.0|6.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 4 hour||6.9|-27.0|
74053054|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|7.6|||TWO_SIDED|95.0|-20.4|11.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 4 hour||11.1|-20.4|
74053055|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-4.2|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|95.0|-19.5|11.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose PM||11.0|-19.5|
74053056|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|6.8|||TWO_SIDED|95.0|-15.4|12.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose PM||12.8|-15.4|
74053057|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-12.7|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-23.0|-2.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9 predose AM||-2.5|-23.0|
74053058|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-5.2|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-14.7|4.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9 predose AM||4.3|-14.7|
74053059|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-8.0|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-19.0|2.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10 predose AM||2.9|-19.0|
74053060|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-14.0|6.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10 predose||6.3|-14.0|
74053061|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-16.1|STANDARD_ERROR_OF_MEAN|7.2|||TWO_SIDED|95.0|-31.0|-1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11 predose AM||-1.2|-31.0|
74053062|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-22.1|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11 predose AM||5.6|-22.1|
74053063|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-14.6|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12 predose AM||7.9|-14.6|
74099776|NCT00261443|147748808|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.06||||0.083|TWO_SIDED|95.0|0.99|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 52||1.13|0.99|0.083
74099777|NCT00261443|147748809|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.78||||0.132|TWO_SIDED|95.0|0.56|1.08|||Stratified Log Rank Test|Stratified Log Rank Test p-value for equality of survival curves.||||1.08|0.56|0.132
74099778|NCT00261443|147748850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.640
74053064|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-5.5|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-15.9|4.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12 predose AM||4.9|-15.9|
74053065|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-11.9|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-22.1|-1.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose AM||-1.7|-22.1|
74053066|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-6.5|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-16.0|2.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose AM||2.9|-16.0|
74053067|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-14.3|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-25.4|-3.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 1 hour||-3.2|-25.4|
74053068|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-11.8|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-22.1|-1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 1 hour||-1.5|-22.1|
74053069|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-29.0|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 4 hour||5.6|-29.0|
74099779|NCT00261443|147748850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.423
74053070|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-9.8|STANDARD_ERROR_OF_MEAN|7.7|||TWO_SIDED|95.0|-25.9|6.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 4 hour||6.2|-25.9|
74053071|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-11.3|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-22.4|-0.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose PM||-0.1|-22.4|
74053072|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-9.9|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-20.2|0.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose PM||0.4|-20.2|
74053073|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-22.0|10.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14 predose AM||10.5|-22.0|
74053074|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-6.1|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|95.0|-21.1|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14 predose AM||9.0|-21.1|
74053075|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-8.1|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-21.7|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15 / Discharge||5.6|-21.7|
74053076|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-5.0|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-17.7|7.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15 / Discharge||7.6|-17.7|
74053077|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|4.8|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-7.0|16.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21 / Follow-up||16.7|-7.0|
74053078|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|5.2|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-5.8|16.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21 / Follow-up||16.2|-5.8|
74053079|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|5.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-11.7|22.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42 / End of Trial||22.6|-11.7|
74053080|NCT03091920|147658179|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|7.7|||TWO_SIDED|95.0|-20.4|11.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42 / End of Trial||11.4|-20.4|
74053081|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-8.9|3.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||3.8|-8.9|
74053082|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.0|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-8.4|4.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||4.5|-8.4|
74099780|NCT00261443|147748850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.297
74099781|NCT00261443|147748850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.707
74099782|NCT00261443|147748851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.656||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.656
74099783|NCT00261443|147748851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.045
74099784|NCT00261443|147748851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.532
74053083|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.2|3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||3.4|-9.2|
74053084|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-13.5|-0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||-0.6|-13.5|
74099785|NCT00261443|147748851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.578||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.578
74099786|NCT00261443|147748852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.619
74099787|NCT00261443|147748852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.868
74099788|NCT00261443|147748852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.284
74099789|NCT00261443|147748852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.481||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.481
74053085|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-5.5|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-11.5|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||0.6|-11.5|
74053086|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.8|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||1.5|-10.8|
74053087|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-9.4|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||2.2|-9.4|
74053088|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-8.0|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||3.7|-8.0|
74053089|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-5.0|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-13.8|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||3.9|-13.8|
74053090|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.7|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-11.7|6.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||6.2|-11.7|
74053091|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.4|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-9.7|0.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||0.9|-9.7|
74053092|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-8.5|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||2.2|-8.5|
74053093|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-6.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-13.1|-0.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||-0.3|-13.1|
74099790|NCT00261443|147748853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.184
74099791|NCT00261443|147748853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.073
73888156|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|164.4|||<|0.0001|TWO_SIDED|95.0|85.8|243.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||243.1|85.8|<0.0001
74053094|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-11.8|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||1.2|-11.8|
74099792|NCT00261443|147748853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.020
74099793|NCT00261443|147748853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.206||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.206
74099794|NCT00261443|147748854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.142||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.142
74099795|NCT00261443|147748854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.110
74099796|NCT00261443|147748854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.022
74099797|NCT00261443|147748854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.542||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.542
74099798|NCT00261443|147748855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.916||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.916
74099799|NCT00261443|147748855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.707
74099800|NCT00261443|147748855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.665
74099801|NCT00261443|147748855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.757||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.757
74053095|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-5.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-14.2|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||3.5|-14.2|
74053096|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-17.5|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||0.5|-17.5|
74053097|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-11.6|0.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||0.2|-11.6|
74053098|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-10.6|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||1.5|-10.6|
74053099|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-7.4|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||6.4|-7.4|
74053100|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.3|4.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||4.7|-9.3|
74099802|NCT00261443|147748856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.871||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.871
74099803|NCT00261443|147748856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.362
74053101|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.4|4.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||4.6|-9.4|
74053102|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-8.7|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||5.6|-8.7|
74053103|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-6.2|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||6.7|-6.2|
74053104|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-6.2|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||6.8|-6.2|
74053105|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|1.5|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-6.4|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||9.4|-6.4|
74053106|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-9.3|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||6.8|-9.3|
74053107|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.0|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||1.4|-10.0|
74053108|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.3|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||1.3|-10.3|
74099804|NCT00261443|147748856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.295
73888157|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|198.0|||<|0.0001|TWO_SIDED|95.0|119.4|276.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||276.6|119.4|<0.0001
74053109|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-8.2|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||3.3|-8.2|
74053110|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-13.0|-1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||-1.3|-13.0|
74053111|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-7.7|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||2.2|-7.7|
74099805|NCT00261443|147748856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.519||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.519
74099806|NCT00261443|147748857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.935||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.935
74099807|NCT00261443|147748857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.174
74099808|NCT00261443|147748857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.527
74099809|NCT00261443|147748857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.753
73881580|NCT03192176|147297634|SUPERIORITY||LSMean difference|2.8|STANDARD_ERROR_OF_MEAN|5.07||0.5838|TWO_SIDED|95.0|-7.2|12.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||12.76|-7.20|0.5838
74053112|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-9.7|0.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||0.3|-9.7|
74053113|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.1|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-11.6|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||3.5|-11.6|
74053114|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-12.0|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||3.3|-12.0|
74053115|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.6|1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||1.9|-10.6|
74053116|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-12.0|0.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||0.7|-12.0|
74053117|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.3|10.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||10.3|-8.3|
73881581|NCT03192176|147297634|SUPERIORITY||LSMean difference|1.1|STANDARD_ERROR_OF_MEAN|5.22||0.8322|TWO_SIDED|95.0|-9.18|11.39||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||11.39|-9.18|0.8322
74053118|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.2|9.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||9.7|-9.2|
74053119|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-11.5|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||2.3|-11.5|
74053120|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.9|4.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||4.2|-9.9|
74053121|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-9.3|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-15.5|-3.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||-3.0|-15.5|
74053122|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-14.6|-1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||-1.9|-14.6|
74053123|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-12.6|2.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||2.0|-12.6|
74053124|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-8.7|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||6.1|-8.7|
74053125|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-8.2|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||6.7|-8.2|
74099810|NCT00261443|147748858|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.850
74053126|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-7.3|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||7.9|-7.3|
74053127|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-10.3|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||0.6|-10.3|
74053128|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-7.7|3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||3.4|-7.7|
74053129|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-3.9|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.0|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose||2.3|-10.0|
74099811|NCT00261443|147748858|SUPERIORITY_OR_OTHER_LEGACY|||||||0.709||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.709
74099812|NCT00261443|147748858|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.326
74099813|NCT00261443|147748858|SUPERIORITY_OR_OTHER_LEGACY|||||||0.201||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.201
73881582|NCT03192176|147297634|SUPERIORITY||LSMean difference|1.8|STANDARD_ERROR_OF_MEAN|5.26||0.7366|TWO_SIDED|95.0|-8.59|12.13||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||12.13|-8.59|0.7366
73888158|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|111.1||||0.0057|TWO_SIDED|95.0|32.8|189.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||189.4|32.8|0.0057
74053130|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-11.4|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose AM||1.2|-11.4|
74053131|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-8.7|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-15.2|-2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||-2.2|-15.2|
74053132|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-12.0|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||1.3|-12.0|
74053133|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-7.6|2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||2.8|-7.6|
74053134|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-9.7|0.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||0.8|-9.7|
74053135|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.7|0.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||0.8|-10.7|
74053136|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.4|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||1.3|-10.4|
74053137|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-9.0|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-14.6|-3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||-3.4|-14.6|
74053138|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-14.2|-2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||-2.8|-14.2|
74053139|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-13.8|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||1.5|-13.8|
74053140|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-6.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-14.3|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||1.2|-14.3|
74053141|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-8.0|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-15.0|-1.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||-1.0|-15.0|
74053142|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-14.2|0.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||0|-14.2|
74053143|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-1.7|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-9.8|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||6.4|-9.8|
74053144|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-8.0|8.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||8.5|-8.0|
74053145|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.0|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||3.7|-9.0|
74053146|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-7.1|5.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||5.8|-7.1|
74099814|NCT00261443|147748859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47||||0.491|TWO_SIDED|95.0|-0.87|1.81||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 (LOCF) Treatment Difference||1.81|-0.87|0.491
74053147|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-5.5|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||3.9|-5.5|
73881583|NCT03192176|147297634|SUPERIORITY||LSMean difference|5.6|STANDARD_ERROR_OF_MEAN|5.4||0.2971|TWO_SIDED|95.0|-4.99|16.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||16.28|-4.99|0.2971
74053148|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-4.6|4.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||4.9|-4.6|
74053149|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|2.1|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-6.5|10.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||10.7|-6.5|
74053150|NCT03091920|147658180|OTHER|No statistical testing was performed.|Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-7.9|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||9.6|-7.9|
74053151|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|6.2|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-4.4|16.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||16.8|-4.4|
74053152|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|9.1|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-1.5|19.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||19.8|-1.5|
74053153|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-9.0|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||9.0|-9.0|
74053154|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-4.6|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||13.4|-4.6|
74053155|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-7.5|7.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||7.1|-7.5|
74053156|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|1.6|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-5.7|8.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||8.9|-5.7|
74053157|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-2.0|12.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||12.1|-2.0|
74053158|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|5.2|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-1.8|12.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||12.3|-1.8|
74053159|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-5.1|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||9.6|-5.1|
74053160|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-6.0|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||8.7|-6.0|
74053161|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.0|6.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||6.9|-5.0|
74053162|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.3|6.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||6.6|-5.3|
74053163|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-8.1|13.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||13.2|-8.1|
74053164|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-6.3|15.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||15.0|-6.3|
74053165|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.6|11.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||11.2|-4.6|
73888159|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|168.1|||<|0.0001|TWO_SIDED|95.0|89.7|246.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.6|89.7|<0.0001
74053166|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-1.0|14.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||14.9|-1.0|
74053167|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-8.5|5.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||5.9|-8.5|
74053168|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-8.5|5.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||5.9|-8.5|
74053169|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.2|9.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||9.5|-9.2|
74053170|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.5|9.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||9.2|-9.5|
74053171|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-5.1|7.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||7.4|-5.1|
74099815|NCT00261443|147748859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04||||0.945|TWO_SIDED|95.0|-1.21|1.12||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value Treatment Difference||1.12|-1.21|0.945
74099816|NCT00261443|147748860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.279||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison||||0.279
74053172|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-3.4|9.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||9.2|-3.4|
74053173|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-7.5|4.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||4.8|-7.5|
74053174|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-6.5|5.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||5.8|-6.5|
74053175|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-9.9|5.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||5.3|-9.9|
74053176|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|2.2|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.4|9.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||9.8|-5.4|
74053177|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|0.2|13.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||13.7|0.2|
74053178|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-1.7|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||11.8|-1.7|
74053179|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-3.1|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||9.0|-3.1|
74053180|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-3.4|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||8.7|-3.4|
74053181|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.4|10.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||10.0|-5.4|
74053182|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.4|7.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||7.0|-8.4|
74099817|NCT00261443|147748860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.247||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison||||0.247
74099818|NCT00261443|147748860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison||||0.329
74099819|NCT00261443|147748860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.928||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison||||0.928
73888160|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|128.4||||0.036|TWO_SIDED|95.0|8.5|248.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||248.3|8.5|0.0360
74053183|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.6|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||11.8|-1.6|
74053184|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.7|11.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||11.7|-1.7|
74053185|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|9.3|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-1.6|20.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||20.2|-1.6|
74053186|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|13.0|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|2.1|23.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||23.9|2.1|
73881584|NCT03192176|147297634|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|5.41||0.9562|TWO_SIDED|95.0|-10.96|10.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||10.37|-10.96|0.9562
73881585|NCT03192176|147297634|SUPERIORITY||0.28|8.7|STANDARD_ERROR_OF_MEAN|5.13||0.0926|TWO_SIDED|95.0|-1.44|18.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||18.76|-1.44|0.0926
74053187|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|7.1|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|0.2|13.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||13.9|0.2|
74053188|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|11.5|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|4.6|18.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||18.3|4.6|
74053189|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|1.9|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-4.8|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||8.6|-4.8|
74053190|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|4.1|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-2.6|10.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose||10.8|-2.6|
74053191|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|9.7|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-0.1|19.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||19.6|-0.1|
74053192|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|9.6|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-0.3|19.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||19.4|-0.3|
74053193|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|7.8|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|0.0|15.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||15.5|0|
74053194|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|8.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|0.6|16.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||16.1|0.6|
74053195|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.1|11.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||11.7|-5.1|
74053196|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|3.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.4|11.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||11.3|-5.4|
74053197|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|1.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-6.1|9.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||9.1|-6.1|
74053198|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.3|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||9.9|-5.3|
74053199|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-4.0|12.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose||12.6|-4.0|
74099820|NCT00261443|147748860|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.17||||0.584|TWO_SIDED|95.0|0.66|2.09||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison||2.09|0.66|0.584
74099821|NCT00261443|147748860|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.26||||0.369|TWO_SIDED|95.0|0.76|2.08||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"||2.08|0.76|0.369
74099822|NCT00261443|147748861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison||||0.685
74053200|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-3.2|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose AM||13.4|-3.2|
74053201|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-11.0|8.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||8.0|-11.0|
74053202|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-10.3|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||8.6|-10.3|
74053203|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-7.7|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||13.4|-7.7|
74099823|NCT00261443|147748861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.792||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison||||0.792
74099824|NCT00261443|147748861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.805||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison||||0.805
74099825|NCT00261443|147748861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison||||0.533
74099826|NCT00261443|147748861|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.545|TWO_SIDED|95.0|0.35|1.74||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison||1.74|0.35|0.545
74099827|NCT00261443|147748861|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.01||||0.987|TWO_SIDED|95.0|0.54|1.86||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"||1.86|0.54|0.987
74053204|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-9.4|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||11.8|-9.4|
74053205|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.4|10.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||10.3|-8.4|
74053206|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.3|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||9.4|-9.3|
74053207|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-1.3|15.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||15.3|-1.3|
74053208|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|9.9|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|1.6|18.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||18.2|1.6|
74099828|NCT00261443|147748862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.646||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Treatment Comparison Baseline||||0.646
74099829|NCT00261443|147748862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 12 Treatment Comparison||||0.006
74053209|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|5.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.0|12.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||12.3|-1.0|
74053210|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|7.2|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|0.5|13.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||13.9|0.5|
74053211|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-8.4|7.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||7.4|-8.4|
74053212|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|1.9|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-6.0|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||9.9|-6.0|
74099830|NCT00261443|147748862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.485||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 24 Treatment Comparison||||0.485
74099831|NCT00261443|147748862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.325||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 36 Treatment Comparison||||0.325
74099832|NCT00261443|147748862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 Treatment Comparison||||0.374
74099833|NCT00261443|147748862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 (LOCF) Treatment Comparison||||0.064
74099834|NCT00261443|147748862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Highest Value Treatment Comparison||||0.310
73881586|NCT03192176|147297634|SUPERIORITY||LSMean difference|3.5|STANDARD_ERROR_OF_MEAN|5.18||0.4996|TWO_SIDED|95.0|-6.7|13.7||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||13.70|-6.70|0.4996
74053213|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|3.9|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.0|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||11.8|-4.0|
74053214|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.6|11.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||11.2|-4.6|
74053215|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.0|7.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||7.3|-8.0|
74053216|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-7.2|8.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||8.1|-7.2|
74099835|NCT00261443|147748862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Lowest Value Treatment Comparison||||0.046
74053217|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-11.5|10.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||10.2|-11.5|
74053218|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|6.7|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-4.1|17.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||17.5|-4.1|
74053219|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.1|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||9.6|-9.1|
74053220|NCT03091920|147658181|OTHER|No statistical testing was performed.|Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.5|10.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||10.2|-8.5|
74053221|NCT03091920|147658186|OTHER|No statistical testing was performed.|Least squares mean difference|-3.32|STANDARD_ERROR_OF_MEAN|3.07|||TWO_SIDED|95.0|-9.68|3.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||3.04|-9.68|
74053222|NCT03091920|147658186|OTHER|No statistical testing was performed.|Least squares mean difference|-2.55|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|95.0|-8.76|3.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||3.66|-8.76|
74053223|NCT03091920|147658186|OTHER|No statistical testing was performed.|Least squares mean difference|-2.93|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-8.62|2.75|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||2.75|-8.62|
74053224|NCT03091920|147658186|OTHER|No statistical testing was performed.|Least squares mean difference|-3.23|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-10.37|3.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||3.92|-10.37|
74099836|NCT00261443|147748864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.331||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALP||||0.331
74099837|NCT00261443|147748864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.353||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in ALP at Week 52 (LOCF)||||0.353
74099838|NCT00261443|147748864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.298||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALP Highest Change Value During Phase 3||||0.298
73881587|NCT03192176|147297634|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|4.76||0.896|TWO_SIDED|95.0|-9.99|8.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||8.75|-9.99|0.8960
74099839|NCT00261443|147748865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALT||||0.111
74053225|NCT03091920|147658186|OTHER|No statistical testing was performed.|Least squares mean difference|0.52|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-6.46|7.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||7.49|-6.46|
74053226|NCT03091920|147658186|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|95.0|-7.74|5.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||5.03|-7.74|
74053227|NCT03091920|147658186|OTHER|No statistical testing was performed.|Least squares mean difference|-2.71|STANDARD_ERROR_OF_MEAN|4.21|||TWO_SIDED|95.0|-11.46|6.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.04|-11.46|
74053228|NCT03091920|147658186|OTHER|No statistical testing was performed.|Least squares mean difference|-1.87|STANDARD_ERROR_OF_MEAN|3.95|||TWO_SIDED|95.0|-10.09|6.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.35|-10.09|
74053229|NCT03091920|147658186|OTHER|No statistical testing was performed.|Least squares mean difference|-2.29|STANDARD_ERROR_OF_MEAN|3.67|||TWO_SIDED|95.0|-9.93|5.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||5.35|-9.93|
74099840|NCT00261443|147748865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in ALT at Week 52 (LOCF)||||0.948
74099841|NCT00261443|147748865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.559||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALT Highest Change Value During Phase 3||||0.559
74099842|NCT00261443|147748866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline AST||||0.077
74053230|NCT03091920|147658187|OTHER|No statistical testing was performed.|Least squares mean difference|-7.06|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-14.52|0.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||0.40|-14.52|
74099843|NCT00261443|147748866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.255||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in AST at Week 52 (LOCF)||||0.255
74099844|NCT00261443|147748866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.918||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison AST Highest Change Value During Phase 3||||0.918
74053231|NCT03091920|147658187|OTHER|No statistical testing was performed.|Least squares mean difference|-4.19|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-11.52|3.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.14|-11.52|
74053232|NCT03091920|147658187|OTHER|No statistical testing was performed.|Least squares mean difference|-3.82|STANDARD_ERROR_OF_MEAN|3.69|||TWO_SIDED|95.0|-11.47|3.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.83|-11.47|
74053233|NCT03091920|147658187|OTHER|No statistical testing was performed.|Least squares mean difference|1.42|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-6.1|8.94|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.94|-6.10|
74053234|NCT03091920|147658187|OTHER|No statistical testing was performed.|Least squares mean difference|-6.44|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-16.36|3.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||3.47|-16.36|
74053235|NCT03091920|147658187|OTHER|No statistical testing was performed.|Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|4.52|||TWO_SIDED|95.0|-10.44|8.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||8.38|-10.44|
74053236|NCT03091920|147658188|OTHER|No statistical testing was performed.|Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|3.26|||TWO_SIDED|95.0|-6.97|6.54|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.54|-6.97|
74099845|NCT00261443|147748867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline BUN||||0.118
74099846|NCT00261443|147748867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in BUN at Week 52 (LOCF)||||0.532
74099847|NCT00261443|147748867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison BUN Highest Value of Change During Phase 3||||0.169
74099848|NCT00261443|147748868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.878||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Cholesterol (fasting)||||0.878
74099849|NCT00261443|147748868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.544||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Total Cholesterol (fasting) at Week 52 (LOCF)||||0.544
74053237|NCT03091920|147658188|OTHER|No statistical testing was performed.|Least squares mean difference|-1.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-8.24|5.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||5.03|-8.24|
74053238|NCT03091920|147658188|OTHER|No statistical testing was performed.|Least squares mean difference|-3.12|STANDARD_ERROR_OF_MEAN|3.74|||TWO_SIDED|95.0|-10.88|4.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||4.65|-10.88|
74053239|NCT03091920|147658188|OTHER|No statistical testing was performed.|Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|3.68|||TWO_SIDED|95.0|-8.45|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||6.80|-8.45|
74053240|NCT03091920|147658188|OTHER|No statistical testing was performed.|Least squares mean difference|0.87|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-7.84|9.58|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||9.58|-7.84|
74053241|NCT03091920|147658188|OTHER|No statistical testing was performed.|Least squares mean difference|-2.98|STANDARD_ERROR_OF_MEAN|3.96|||TWO_SIDED|95.0|-11.23|5.26|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||5.26|-11.23|
74053242|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-5.55|STANDARD_ERROR_OF_MEAN|3.84|||TWO_SIDED|95.0|-13.51|2.41|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.41|-13.51|
74053243|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-2.47|STANDARD_ERROR_OF_MEAN|3.83|||TWO_SIDED|95.0|-10.41|5.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||5.47|-10.41|
74053244|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-8.05|STANDARD_ERROR_OF_MEAN|4.49|||TWO_SIDED|95.0|-17.36|1.25|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||1.25|-17.36|
73888161|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|221.5||||0.0004|TWO_SIDED|95.0|101.2|341.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||341.7|101.2|0.0004
74053245|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-8.28|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|-17.42|0.87|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||0.87|-17.42|
74053246|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-9.34|STANDARD_ERROR_OF_MEAN|4.86|||TWO_SIDED|95.0|-19.43|0.74|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||0.74|-19.43|
74053247|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-3.05|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-12.95|6.84|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||6.84|-12.95|
74053248|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|3.36|STANDARD_ERROR_OF_MEAN|3.91|||TWO_SIDED|95.0|-4.74|11.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||11.47|-4.74|
74053249|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|2.82|STANDARD_ERROR_OF_MEAN|3.82|||TWO_SIDED|95.0|-5.1|10.75|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||10.75|-5.10|
74053250|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-4.43|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-15.23|6.37|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.37|-15.23|
74099850|NCT00261443|147748868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.658||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Cholesterol (fasting) in Phase 3||||0.658
74099851|NCT00261443|147748869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatine Kinase||||0.043
74099852|NCT00261443|147748869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from baseline in Creatine Kinase at Week 52 (LOCF)||||0.019
74099853|NCT00261443|147748869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatine Kinase During Phase 3||||0.176
74099854|NCT00261443|147748870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.105||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatinine||||0.105
74099855|NCT00261443|147748870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.634||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Creatinine at Week 52 (LOCF)||||0.634
74099856|NCT00261443|147748870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatinine During Phase 3||||0.958
74099857|NCT00261443|147748871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Eosinophils (relative)||||0.507
74099858|NCT00261443|147748871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.834||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Eosinophils (relative) at Week 52 (LOCF)||||0.834
74099859|NCT00261443|147748871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.511||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Eosinophils (relative) During Phase 3||||0.511
74053251|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-4.85|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-15.65|5.94|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.94|-15.65|
74053252|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-0.81|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-9.1|7.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||7.47|-9.10|
74053253|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-2.63|STANDARD_ERROR_OF_MEAN|3.76|||TWO_SIDED|95.0|-10.42|5.16|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.16|-10.42|
74053254|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-5.54|STANDARD_ERROR_OF_MEAN|3.98|||TWO_SIDED|95.0|-13.8|2.72|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||2.72|-13.80|
74053255|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|3.97|||TWO_SIDED|95.0|-8.25|8.23|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||8.23|-8.25|
74099860|NCT00261443|147748872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Glucose (fasting)||||0.741
74099861|NCT00261443|147748872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.962||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Glucose (fasting) at Week 52 (LOCF)||||0.962
74099862|NCT00261443|147748872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in Glucose (fasting) During Phase 3||||0.592
74099863|NCT00261443|147748873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hemoglobin||||0.080
74053256|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-2.89|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-12.01|6.23|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||6.23|-12.01|
74053257|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|2.17|STANDARD_ERROR_OF_MEAN|4.32|||TWO_SIDED|95.0|-6.78|11.13|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||11.13|-6.78|
74053258|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-4.23|STANDARD_ERROR_OF_MEAN|4.68|||TWO_SIDED|95.0|-13.93|5.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||5.47|-13.93|
74099864|NCT00261443|147748873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hemoglobin at Week 52 (LOCF)||||0.868
74053259|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|1.37|STANDARD_ERROR_OF_MEAN|4.59|||TWO_SIDED|95.0|-8.14|10.88|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||10.88|-8.14|
74053260|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-0.57|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-10.32|9.18|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||9.18|-10.32|
74053261|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|2.49|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-7.04|12.02|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||12.02|-7.04|
74099865|NCT00261443|147748873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Change Value in Hemoglobin During Phase 3||||0.299
73888162|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|126.7||||0.0388|TWO_SIDED|95.0|6.6|246.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.8|6.6|0.0388
74053262|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-7.89|STANDARD_ERROR_OF_MEAN|5.03|||TWO_SIDED|95.0|-18.33|2.55|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||2.55|-18.33|
74053263|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-6.49|STANDARD_ERROR_OF_MEAN|5.03|||TWO_SIDED|95.0|-16.92|3.95|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||3.95|-16.92|
74099866|NCT00261443|147748874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.187||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hematocrit||||0.187
74099867|NCT00261443|147748874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.377||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hematocrit During Week 52 (LOCF)||||0.377
74099868|NCT00261443|147748874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.494||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Hematocrit During Phase 3||||0.494
74099869|NCT00261443|147748875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HDL Cholesterol (fasting)||||0.180
74099870|NCT00261443|147748875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HDL Cholesterol (fasting) at Week 52 (LOCF)||||0.950
74053264|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-3.84|STANDARD_ERROR_OF_MEAN|4.91|||TWO_SIDED|95.0|-14.03|6.35|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.35|-14.03|
74053265|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|0.78|STANDARD_ERROR_OF_MEAN|4.62|||TWO_SIDED|95.0|-8.8|10.35|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||10.35|-8.80|
74053266|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-7.13|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-17.79|3.53|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||3.53|-17.79|
74053267|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|1.66|STANDARD_ERROR_OF_MEAN|4.93|||TWO_SIDED|95.0|-8.59|11.91|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||11.91|-8.59|
74053268|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-6.31|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|95.0|-16.17|3.55|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||3.55|-16.17|
74099871|NCT00261443|147748875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.342||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in HDL Cholesterol (fasting) During Phase 3||||0.342
74099872|NCT00261443|147748876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-Percent Beta||||0.349
74099873|NCT00261443|147748876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.624||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-Percent Beta at Week 52 (LOCF)||||0.624
74099874|NCT00261443|147748876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value in HOMA2-Percent Beta During Phase 3||||0.329
74053269|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-1.17|STANDARD_ERROR_OF_MEAN|4.54|||TWO_SIDED|95.0|-10.6|8.27|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||8.27|-10.60|
74053270|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-7.01|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-19.13|5.11|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||5.11|-19.13|
74053271|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-4.11|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-15.55|7.34|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||7.34|-15.55|
74099875|NCT00261443|147748877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-IR||||0.550
74099876|NCT00261443|147748877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.554||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-IR at Week 52 (LOCF)||||0.554
74053272|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|1.77|STANDARD_ERROR_OF_MEAN|5.48|||TWO_SIDED|95.0|-9.63|13.17|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||13.17|-9.63|
74053273|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-3.47|STANDARD_ERROR_OF_MEAN|5.18|||TWO_SIDED|95.0|-14.25|7.31|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.31|-14.25|
74053274|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-1.73|STANDARD_ERROR_OF_MEAN|4.57|||TWO_SIDED|95.0|-11.24|7.77|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||7.77|-11.24|
74099877|NCT00261443|147748877|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample||||0.870
74053275|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|-5.55|STANDARD_ERROR_OF_MEAN|4.46|||TWO_SIDED|95.0|-14.83|3.73|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.73|-14.83|
74053276|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|1.98|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-8.85|12.81|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||12.81|-8.85|
74099878|NCT00261443|147748878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase||||0.004
74099879|NCT00261443|147748878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase||||0.034
74099880|NCT00261443|147748878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Lactate Dehydrogenase During Phase 3||||0.091
74099881|NCT00261443|147748879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.808||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline LDL Cholesterol (fasting)||||0.808
74099882|NCT00261443|147748879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.507
74099883|NCT00261443|147748879|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in LDL Cholesterol (fasting)||||0.948
73881588|NCT03192176|147297634|SUPERIORITY||LSMean difference|2.9|STANDARD_ERROR_OF_MEAN|4.89||0.5471|TWO_SIDED|95.0|-6.68|12.58||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||12.58|-6.68|0.5471
73881589|NCT03192176|147297634|SUPERIORITY||LSMean difference|1.7|STANDARD_ERROR_OF_MEAN|4.93||0.738|TWO_SIDED|95.0|-8.06|11.36||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||11.36|-8.06|0.7380
73881590|NCT03192176|147297634|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|5.14||0.0644|TWO_SIDED|95.0|-0.58|19.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||19.69|-0.58|0.0644
73881591|NCT03192176|147297634|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|5.04||0.8475|TWO_SIDED|95.0|-10.9|8.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||8.96|-10.90|0.8475
73881592|NCT03192176|147297634|SUPERIORITY||LSMean difference|5.0|STANDARD_ERROR_OF_MEAN|4.86||0.3044|TWO_SIDED|95.0|-4.57|14.59||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||14.59|-4.57|0.3044
74053277|NCT03091920|147658189|OTHER|No statistical testing was performed.|Least squares mean difference|1.07|STANDARD_ERROR_OF_MEAN|4.69|||TWO_SIDED|95.0|-8.68|10.82|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||10.82|-8.68|
74053278|NCT03091920|147658190|OTHER|No statistical testing was performed.|Least squares mean difference|-2.12|STANDARD_ERROR_OF_MEAN|2.06|||TWO_SIDED|95.0|-6.38|2.15|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.15|-6.38|
74053279|NCT03091920|147658190|OTHER|No statistical testing was performed.|Least squares mean difference|-2.39|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-6.59|1.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.80|-6.59|
74099884|NCT00261443|147748880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.967||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Neutrophils (relative)||||0.967
74053280|NCT03091920|147658190|OTHER|No statistical testing was performed.|Least squares mean difference|-2.26|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|95.0|-6.11|1.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||1.60|-6.11|
74053281|NCT03091920|147658190|OTHER|No statistical testing was performed.|Least squares mean difference|-3.39|STANDARD_ERROR_OF_MEAN|2.34|||TWO_SIDED|95.0|-8.25|1.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.47|-8.25|
73881593|NCT03192176|147297634|SUPERIORITY||LSMean difference|4.2|STANDARD_ERROR_OF_MEAN|4.89||0.3895|TWO_SIDED|95.0|-5.42|13.86||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||13.86|-5.42|0.3895
73881594|NCT03192176|147297634|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|6.07||0.4551|TWO_SIDED|95.0|-16.5|7.42||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||7.42|-16.50|0.4551
73881595|NCT03192176|147297634|SUPERIORITY||LSMean differencce|-2.2|STANDARD_ERROR_OF_MEAN|6.1||0.7182|TWO_SIDED|95.0|-14.21|9.81||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||9.81|-14.21|0.7182
73881596|NCT03192176|147297634|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|6.21||0.6259|TWO_SIDED|95.0|-15.26|9.2||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||9.20|-15.26|0.6259
74053282|NCT03091920|147658190|OTHER|No statistical testing was performed.|Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|2.31|||TWO_SIDED|95.0|-6.4|3.18|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.18|-6.40|
74053283|NCT03091920|147658190|OTHER|No statistical testing was performed.|Least squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-6.9|1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||1.90|-6.90|
74053284|NCT03091920|147658190|OTHER|No statistical testing was performed.|Least squares mean difference|-4.96|STANDARD_ERROR_OF_MEAN|3.01|||TWO_SIDED|95.0|-11.22|1.31|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.31|-11.22|
74053285|NCT03091920|147658190|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.84|||TWO_SIDED|95.0|-10.41|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.40|-10.41|
74053286|NCT03091920|147658190|OTHER|No statistical testing was performed.|Least squares mean difference|-4.73|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|95.0|-10.27|0.81|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||0.81|-10.27|
74053287|NCT03091920|147658191|OTHER|No statistical testing was performed.|Least squares mean difference|-4.87|STANDARD_ERROR_OF_MEAN|2.86|||TWO_SIDED|95.0|-10.8|1.06|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.06|-10.80|
74053288|NCT03091920|147658191|OTHER|No statistical testing was performed.|Least squares mean difference|-5.02|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-10.87|0.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||0.83|-10.87|
74053289|NCT03091920|147658191|OTHER|No statistical testing was performed.|Least squares mean difference|-4.23|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-9.55|1.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.10|-9.55|
74053290|NCT03091920|147658191|OTHER|No statistical testing was performed.|Least squares mean difference|-2.15|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-7.4|3.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.11|-7.40|
74053291|NCT03091920|147658191|OTHER|No statistical testing was performed.|Least squares mean difference|-8.74|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.64|-1.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||-1.85|-15.64|
74099885|NCT00261443|147748880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.486||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison in change from Baseline in Neutrophils (relative) at Week 52 (LOCF)||||0.486
74099886|NCT00261443|147748880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.323||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Neutrophils (relative), Phase 3 Safety Sample||||0.323
74053292|NCT03091920|147658191|OTHER|No statistical testing was performed.|Least squares mean difference|-5.34|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-11.84|1.15|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.15|-11.84|
74053293|NCT03091920|147658192|OTHER|No statistical testing was performed.|Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-4.86|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.96|-4.86|
74053294|NCT03091920|147658192|OTHER|No statistical testing was performed.|Least squares mean difference|-0.71|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-5.07|3.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.65|-5.07|
74053295|NCT03091920|147658192|OTHER|No statistical testing was performed.|Least squares mean difference|-3.32|STANDARD_ERROR_OF_MEAN|2.64|||TWO_SIDED|95.0|-8.79|2.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.14|-8.79|
74053296|NCT03091920|147658192|OTHER|No statistical testing was performed.|Least squares mean difference|-1.74|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|-7.14|3.67|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.67|-7.14|
74053297|NCT03091920|147658192|OTHER|No statistical testing was performed.|Least squares mean difference|-1.88|STANDARD_ERROR_OF_MEAN|3.22|||TWO_SIDED|95.0|-8.58|4.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||4.83|-8.58|
74053298|NCT03091920|147658192|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|95.0|-10.69|2.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||2.10|-10.69|
74053299|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-4.45|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-11.3|2.41|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.41|-11.30|
74053300|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-5.17|STANDARD_ERROR_OF_MEAN|3.34|||TWO_SIDED|95.0|-12.1|1.75|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||1.75|-12.10|
74053301|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-5.23|STANDARD_ERROR_OF_MEAN|3.69|||TWO_SIDED|95.0|-12.87|2.42|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||2.42|-12.87|
74053302|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-8.22|STANDARD_ERROR_OF_MEAN|3.58|||TWO_SIDED|95.0|-15.64|-0.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||-0.79|-15.64|
74053303|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-6.72|STANDARD_ERROR_OF_MEAN|3.65|||TWO_SIDED|95.0|-14.29|0.86|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||0.86|-14.29|
74053304|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-3.14|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-10.66|4.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||4.38|-10.66|
74053305|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-4.71|5.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||5.45|-4.71|
74099887|NCT00261443|147748881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.663||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline in Platelet Count||||0.663
74053306|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|2.37|||TWO_SIDED|95.0|-4.94|4.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16||4.91|-4.94|
74053307|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-2.33|STANDARD_ERROR_OF_MEAN|3.73|||TWO_SIDED|95.0|-10.07|5.41|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.41|-10.07|
74053308|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-2.45|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-10.26|5.37|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.37|-10.26|
74053309|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-0.75|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-6.62|5.13|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.13|-6.62|
74053310|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-1.13|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|95.0|-6.83|4.58|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||4.58|-6.83|
74053311|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-5.13|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-10.72|0.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||0.47|-10.72|
74053312|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-3.64|STANDARD_ERROR_OF_MEAN|2.72|||TWO_SIDED|95.0|-9.29|2.01|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||2.01|-9.29|
74053313|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-3.92|STANDARD_ERROR_OF_MEAN|3.52|||TWO_SIDED|95.0|-11.22|3.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||3.38|-11.22|
74053314|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-2.46|STANDARD_ERROR_OF_MEAN|3.42|||TWO_SIDED|95.0|-9.54|4.63|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||4.63|-9.54|
74053315|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-4.75|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-10.9|1.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||1.39|-10.90|
74053316|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-1.25|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-7.35|4.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||4.85|-7.35|
74053317|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-2.11|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|-8.57|4.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.35|-8.57|
73888163|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|223.2||||0.0003|TWO_SIDED|95.0|103.2|343.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||343.2|103.2|0.0003
74053318|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|0.05|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-6.21|6.31|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||6.31|-6.21|
74053319|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-6.66|STANDARD_ERROR_OF_MEAN|3.65|||TWO_SIDED|95.0|-14.22|0.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.90|-14.22|
74053320|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-6.38|STANDARD_ERROR_OF_MEAN|3.68|||TWO_SIDED|95.0|-14.01|1.25|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||1.25|-14.01|
74053321|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-2.29|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-9.3|4.71|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||4.71|-9.30|
74053322|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|3.28|||TWO_SIDED|95.0|-6.97|6.64|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.64|-6.97|
74053323|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-7.74|STANDARD_ERROR_OF_MEAN|3.51|||TWO_SIDED|95.0|-15.03|-0.44|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||-0.44|-15.03|
74053324|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-3.86|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|-10.88|3.16|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||3.16|-10.88|
74053325|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-9.53|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|95.0|-16.1|-2.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8||-2.95|-16.10|
74053326|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-5.66|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-11.82|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||0.50|-11.82|
74053327|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-8.62|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-17.77|0.54|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||0.54|-17.77|
74053328|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-6.05|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-14.79|2.69|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||2.69|-14.79|
74053329|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-10.51|7.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.79|-10.51|
74053330|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-4.95|STANDARD_ERROR_OF_MEAN|4.11|||TWO_SIDED|95.0|-13.5|3.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||3.60|-13.50|
74053331|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-3.43|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|-10.81|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.96|-10.81|
74053332|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-5.38|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-12.64|1.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||1.89|-12.64|
74053333|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|95.0|-7.55|7.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||7.39|-7.55|
74053334|NCT03091920|147658193|OTHER|No statistical testing was performed.|Least squares mean difference|-1.89|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|-8.89|5.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||5.12|-8.89|
74053335|NCT03091920|147658194|OTHER|No statistical testing was performed.|Least squares mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|95.0|-4.17|2.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.59|-4.17|
74053336|NCT03091920|147658194|OTHER|No statistical testing was performed.|Least squares mean difference|-1.09|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|95.0|-4.47|2.29|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.29|-4.47|
74053337|NCT03091920|147658194|OTHER|No statistical testing was performed.|Least squares mean difference|-0.94|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|95.0|-4.02|2.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||2.14|-4.02|
74053338|NCT03091920|147658194|OTHER|No statistical testing was performed.|Least squares mean difference|-2.67|STANDARD_ERROR_OF_MEAN|1.89|||TWO_SIDED|95.0|-6.6|1.26|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.26|-6.60|
74099888|NCT00261443|147748881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.322
74053339|NCT03091920|147658194|OTHER|No statistical testing was performed.|Least squares mean difference|-1.84|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-5.77|2.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.10|-5.77|
74053340|NCT03091920|147658194|OTHER|No statistical testing was performed.|Least squares mean difference|-2.25|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|95.0|-5.83|1.32|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||1.32|-5.83|
74053341|NCT03091920|147658194|OTHER|No statistical testing was performed.|Least squares mean difference|-3.97|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|-9.5|1.56|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.56|-9.50|
74053342|NCT03091920|147658194|OTHER|No statistical testing was performed.|Least squares mean difference|-4.17|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-9.52|1.18|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.18|-9.52|
74053343|NCT03091920|147658194|OTHER|No statistical testing was performed.|Least squares mean difference|-4.07|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-9.01|0.87|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||0.87|-9.01|
74053344|NCT03091920|147658195|OTHER|No statistical testing was performed.|Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|95.0|-8.01|1.21|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.21|-8.01|
74053345|NCT03091920|147658195|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.23|||TWO_SIDED|95.0|-8.21|1.02|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.02|-8.21|
74053346|NCT03091920|147658195|OTHER|No statistical testing was performed.|Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-7.53|0.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||0.92|-7.53|
74099889|NCT00261443|147748881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.358||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Platelet Count, Phase 3 Safety Sample||||0.358
74099890|NCT00261443|147748881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.541||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Platelet Count, Phase 3 Safety Sample||||0.541
74099891|NCT00261443|147748882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.412||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Prolactin||||0.412
74099892|NCT00261443|147748882|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline at Week 52 (LOCF)||||<0.001
74099893|NCT00261443|147748882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Prolactin, Phase 3 Safety Sample||||0.004
74099894|NCT00261443|147748883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Bilirubin||||0.630
74099895|NCT00261443|147748883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.675
74053347|NCT03091920|147658195|OTHER|No statistical testing was performed.|Least squares mean difference|-2.01|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-6.24|2.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.23|-6.24|
74053348|NCT03091920|147658195|OTHER|No statistical testing was performed.|Least squares mean difference|-7.29|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-12.8|-1.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||-1.79|-12.80|
74053349|NCT03091920|147658195|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-10.43|0.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||0.23|-10.43|
74099896|NCT00261443|147748883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample||||0.592
74053350|NCT03091920|147658196|OTHER|No statistical testing was performed.|Least squares mean difference|0.99|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-2.97|4.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||4.95|-2.97|
74099897|NCT00261443|147748884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Triglycerides (fasting)||||0.273
74099898|NCT00261443|147748884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.489||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.489
74099899|NCT00261443|147748884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.415||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Triglycerides (fasting), Phase 3 Safety Sample||||0.415
74099900|NCT00261443|147748885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Uric Acid||||0.189
74099901|NCT00261443|147748885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.350
74053351|NCT03091920|147658196|OTHER|No statistical testing was performed.|Least squares mean difference|0.55|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-3.41|4.52|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||4.52|-3.41|
74053352|NCT03091920|147658196|OTHER|No statistical testing was performed.|Least squares mean difference|-2.54|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-7.63|2.56|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.56|-7.63|
74053353|NCT03091920|147658196|OTHER|No statistical testing was performed.|Least squares mean difference|-2.26|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-7.36|2.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.85|-7.36|
74099902|NCT00261443|147748885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Uric Acid, Phase 3 Safety Sample||||0.799
74099903|NCT00261443|147748886|SUPERIORITY_OR_OTHER_LEGACY|||||||0.124||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Leukocytes||||0.124
74099904|NCT00261443|147748886|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.295
74099905|NCT00261443|147748886|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Highest Value of Change in Leukocytes, Phase 3||||0.735
74099906|NCT00261443|147748886|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Lowest Value of Change in Leukocytes, Phase 3||||0.505
74099907|NCT00261443|147748888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.213||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc Bazett||||0.213
74099908|NCT00261443|147748888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc Bazett at Week 52 (LOCF)||||0.708
74099909|NCT00261443|147748888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.107||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc Bazett, Phase 3||||0.107
74099910|NCT00261443|147748889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc (0.33)||||0.205
74099911|NCT00261443|147748889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.669||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc (0.33) at Week 52 (LOCF)||||0.669
74019447|NCT02804763|147591171|SUPERIORITY||LS Mean Difference vs PBO|11.9|||||TWO_SIDED|95.0|-8.7|32.5||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||32.5|-8.7|
74019448|NCT02804763|147591171|SUPERIORITY||LS Mean Difference vs PBO|17.6|||||TWO_SIDED|95.0|-3.2|38.3||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||38.3|-3.2|
74019449|NCT02804763|147591171|SUPERIORITY||LS Mean Difference vs PBO|15.2|||||TWO_SIDED|95.0|-5.2|35.6||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||35.6|-5.2|
74019450|NCT04656990|147591230|SUPERIORITY||Slope|17.1|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
74019451|NCT04656990|147591233|SUPERIORITY||Slope|3.4|||=|0.04|TWO_SIDED||||||Mixed Models Analysis|||||||=0.04
74019452|NCT03657459|147591258|SUPERIORITY|||||||0.0096|||||||Chi-squared|Pearsons Chi Square||||||0.0096
74019453|NCT03657459|147591259|SUPERIORITY|||||||0.9||||||no adjustment|Chi-squared|Pearson Chi-square||||||0.90
74019454|NCT00282243|147591270|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.79|||||TWO_SIDED|90.0|85.42|92.29|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||92.29|85.42|
74019455|NCT00282243|147591272|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|81.4|||||TWO_SIDED|90.0|77.88|85.08|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||85.08|77.88|
74053354|NCT03091920|147658196|OTHER|No statistical testing was performed.|Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|3.13|||TWO_SIDED|95.0|-7.55|5.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||5.49|-7.55|
74053355|NCT03091920|147658196|OTHER|No statistical testing was performed.|Least squares mean difference|-3.68|STANDARD_ERROR_OF_MEAN|3.04|||TWO_SIDED|95.0|-10.0|2.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||2.65|-10.00|
74053356|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-2.58|STANDARD_ERROR_OF_MEAN|2.49|||TWO_SIDED|95.0|-7.76|2.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.59|-7.76|
74053357|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-4.06|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-9.32|1.19|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||1.19|-9.32|
74053358|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-3.86|STANDARD_ERROR_OF_MEAN|2.73|||TWO_SIDED|95.0|-9.51|1.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||1.80|-9.51|
74053359|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-4.73|STANDARD_ERROR_OF_MEAN|2.73|||TWO_SIDED|95.0|-10.4|0.93|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||0.93|-10.40|
74053360|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-12.06|1.86|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||1.86|-12.06|
74053361|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-2.96|STANDARD_ERROR_OF_MEAN|3.33|||TWO_SIDED|95.0|-9.87|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||3.96|-9.87|
74053362|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|0.87|STANDARD_ERROR_OF_MEAN|2.69|||TWO_SIDED|95.0|-4.7|6.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||6.45|-4.70|
74053363|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|0.55|STANDARD_ERROR_OF_MEAN|2.63|||TWO_SIDED|95.0|-4.9|6.01|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||6.01|-4.90|
74053364|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|-7.22|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.10|-7.22|
74053365|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|3.28|||TWO_SIDED|95.0|-7.27|6.34|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.34|-7.27|
74053366|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|1.72|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-3.26|6.69|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||6.69|-3.26|
74053367|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-4.69|5.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.20|-4.69|
74053368|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-4.43|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|95.0|-8.5|-0.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||-0.36|-8.50|
74053369|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-4.17|STANDARD_ERROR_OF_MEAN|1.99|||TWO_SIDED|95.0|-8.3|-0.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||-0.03|-8.30|
74053370|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-3.39|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.82|3.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||3.04|-9.82|
74053371|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-1.06|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|-7.51|5.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||5.38|-7.51|
74053372|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-2.82|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-8.12|2.48|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||2.48|-8.12|
74053373|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|95.0|-6.63|3.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||3.91|-6.63|
74053374|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-1.19|STANDARD_ERROR_OF_MEAN|2.97|||TWO_SIDED|95.0|-7.35|4.97|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.97|-7.35|
74053375|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-1.26|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|95.0|-7.3|4.77|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.77|-7.30|
74053376|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-5.86|STANDARD_ERROR_OF_MEAN|3.29|||TWO_SIDED|95.0|-12.68|0.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.95|-12.68|
74099912|NCT00261443|147748889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc (0.33), Phase 3||||0.072
74099913|NCT00261443|147748890|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline PR||||0.012
74099914|NCT00261443|147748890|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in PR at Week 52 (LOCF)||||0.027
74099915|NCT00261443|147748890|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in PR, Phase 3||||0.128
74099916|NCT00261443|147748891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.571||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline RR||||0.571
74099917|NCT00261443|147748891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.353||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in RR at Week 52 (LOCF)||||0.353
74099918|NCT00261443|147748891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in RR, Phase 3 Safety Sample||||0.204
74099919|NCT00261443|147748891|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Prolactin, Phase 3 Safety Sample||||0.435
73881597|NCT03192176|147297634|SUPERIORITY||LSMean difference|6.6|STANDARD_ERROR_OF_MEAN|6.5||0.312|TWO_SIDED|95.0|-6.22|19.4||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||19.40|-6.22|0.3120
74099920|NCT00261443|147748892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.826||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QRS||||0.826
74053377|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-13.16|0.76|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.76|-13.16|
74053378|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-7.87|4.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||4.65|-7.87|
74053379|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-0.63|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-6.85|5.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||5.59|-6.85|
74053380|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-6.91|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-12.74|-1.08|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||-1.08|-12.74|
74053381|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-4.04|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-9.73|1.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||1.66|-9.73|
74099921|NCT00261443|147748892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.545||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QRS at Week 52 (LOCF)||||0.545
74099922|NCT00261443|147748892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QRS, Phase 3||||0.372
74099923|NCT00261443|147748893|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.235|TWO_SIDED|95.0|-0.07|0.27||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.27|-0.07|0.235
74099924|NCT00261443|147748893|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36||||0.012|TWO_SIDED|95.0|0.08|0.64||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value in Change Treatment Difference||0.64|0.08|0.012
74099925|NCT00261443|147748894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.587||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Heart Rate||||0.587
74099926|NCT00261443|147748894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in Heart Rate at Week 52 (LOCF)||||0.386
74099927|NCT00261443|147748894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.405||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Heart Rate, Phase 3||||0.405
74099928|NCT00261443|147748894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.253||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Heart Rate, Phase 3||||0.253
74053382|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-8.25|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-13.59|-2.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||-2.91|-13.59|
74053383|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-5.56|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-10.76|-0.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||-0.35|-10.76|
74099929|NCT00261443|147748895|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.514|TWO_SIDED|95.0|-0.12|0.23||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.23|-0.12|0.514
74099930|NCT00261443|147748895|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.362|TWO_SIDED|95.0|-0.14|0.38||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||0.38|-0.14|0.362
73881598|NCT03192176|147297634|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|6.41||0.3297|TWO_SIDED|95.0|-18.89|6.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||6.37|-18.89|0.3297
74053384|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-7.07|STANDARD_ERROR_OF_MEAN|3.91|||TWO_SIDED|95.0|-15.2|1.05|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||1.05|-15.20|
74053385|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-5.85|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-13.68|1.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||1.98|-13.68|
74099931|NCT00261443|147748896|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.904|TWO_SIDED|95.0|-0.04|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.04|-0.04|0.904
74099932|NCT00261443|147748896|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.222|TWO_SIDED|95.0|-0.03|0.11||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||0.11|-0.03|0.222
74099933|NCT00261443|147748897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.808|TWO_SIDED|95.0|-0.03|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.04|-0.03|0.808
74053386|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-10.14|7.33|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.33|-10.14|
74053387|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-5.16|STANDARD_ERROR_OF_MEAN|3.99|||TWO_SIDED|95.0|-13.46|3.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||3.14|-13.46|
74053388|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-2.37|STANDARD_ERROR_OF_MEAN|3.74|||TWO_SIDED|95.0|-10.14|5.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||5.40|-10.14|
74053389|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-4.51|STANDARD_ERROR_OF_MEAN|3.72|||TWO_SIDED|95.0|-12.25|3.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.23|-12.25|
74053390|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-0.44|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-7.6|6.72|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||6.72|-7.60|
74053391|NCT03091920|147658197|OTHER|No statistical testing was performed.|Least squares mean difference|-1.98|STANDARD_ERROR_OF_MEAN|3.32|||TWO_SIDED|95.0|-8.88|4.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.92|-8.88|
74053392|NCT03091920|147658198|OTHER|No statistical testing was performed.|Least squares mean difference|3.19|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|-0.1|6.48|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.48|-0.10|
74099934|NCT00261443|147748897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.771||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||||0.771
74053393|NCT03091920|147658198|OTHER|No statistical testing was performed.|Least squares mean difference|3.53|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|0.25|6.82|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.82|0.25|
74053394|NCT03091920|147658198|OTHER|No statistical testing was performed.|Least squares mean difference|3.36|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|0.4|6.32|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||6.32|0.40|
74053395|NCT03091920|147658198|OTHER|No statistical testing was performed.|Least squares mean difference|4.59|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|95.0|0.95|8.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.23|0.95|
74053396|NCT03091920|147658198|OTHER|No statistical testing was performed.|Least squares mean difference|4.49|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|95.0|0.86|8.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.12|0.86|
74099935|NCT00261443|147748898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01||||0.576|TWO_SIDED|95.0|-0.05|0.03||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.03|-0.05|0.576
74099936|NCT00261443|147748898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.636|TWO_SIDED|95.0|-0.05|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value treatment Difference||0.08|-0.05|0.636
74099937|NCT00261443|147748899|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.774|TWO_SIDED|95.0|-0.06|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.08|-0.06|0.774
74099938|NCT00261443|147748899|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.04||||0.444|TWO_SIDED|95.0|-0.06|0.14||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change, Treatment Difference||0.14|-0.06|0.444
74099939|NCT02089659|147748944|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.72|1.35|||||Moderate hepatic insufficiency / Healthy controls|||1.35|0.72|
74099940|NCT02089659|147748945|OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.66|1.24|||||Moderate hepatic insufficiency / Healthy controls|||1.24|0.66|
74099941|NCT02089659|147748946|OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|90.0|0.74|1.18|||||Moderate hepatic insufficiency / Healthy controls|||1.18|0.74|
74053397|NCT03091920|147658198|OTHER|No statistical testing was performed.|Least squares mean difference|4.54|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|1.27|7.81|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||7.81|1.27|
74053398|NCT03091920|147658198|OTHER|No statistical testing was performed.|Least squares mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.94|||TWO_SIDED|95.0|-1.45|6.61|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||6.61|-1.45|
74053399|NCT03091920|147658198|OTHER|No statistical testing was performed.|Least squares mean difference|3.17|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-0.78|7.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.11|-0.78|
74053400|NCT03091920|147658198|OTHER|No statistical testing was performed.|Least squares mean difference|2.87|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|95.0|-0.71|6.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.45|-0.71|
74053401|NCT03091920|147658199|OTHER|No statistical testing was performed.|Least squares mean difference|2.17|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-2.65|6.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.99|-2.65|
74053402|NCT03091920|147658199|OTHER|No statistical testing was performed.|Least squares mean difference|4.09|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-0.73|8.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||8.91|-0.73|
74053403|NCT03091920|147658199|OTHER|No statistical testing was performed.|Least squares mean difference|4.56|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|0.6|8.51|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.51|0.60|
74053404|NCT03091920|147658199|OTHER|No statistical testing was performed.|Least squares mean difference|4.02|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|0.07|7.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||7.98|0.07|
74099942|NCT02089659|147748947|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.74|1.33|||||Moderate hepatic insufficiency / Healthy controls|||1.33|0.74|
74099943|NCT02657928|147748952|SUPERIORITY|||||||0.5004|||||||Log Rank|||||||0.5004
74099944|NCT02657928|147748953|SUPERIORITY|||||||0.9127|||||||Log Rank|||||||0.9127
74053405|NCT03091920|147658199|OTHER|No statistical testing was performed.|Least squares mean difference|3.12|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-1.15|7.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.39|-1.15|
74053406|NCT03091920|147658199|OTHER|No statistical testing was performed.|Least squares mean difference|3.74|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-0.44|7.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.92|-0.44|
74053407|NCT03091920|147658200|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|1.1|7.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||7.49|1.10|
74053408|NCT03091920|147658200|OTHER|No statistical testing was performed.|Least squares mean difference|2.94|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|95.0|-0.23|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.10|-0.23|
74053409|NCT03091920|147658200|OTHER|No statistical testing was performed.|Least squares mean difference|4.8|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|95.0|0.5|9.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||9.11|0.50|
74053410|NCT03091920|147658200|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|0.84|9.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||9.36|0.84|
74053411|NCT03091920|147658200|OTHER|No statistical testing was performed.|Least squares mean difference|1.89|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-2.93|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||6.70|-2.93|
74053412|NCT03091920|147658200|OTHER|No statistical testing was performed.|Least squares mean difference|2.55|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.15|7.25|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.25|-2.15|
74053413|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|6.81|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|1.4|12.22|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||12.22|1.40|
74053414|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|6.55|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|95.0|1.12|11.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||11.99|1.12|
74053415|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|-0.95|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-8.18|6.28|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||6.28|-8.18|
74053416|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|1.85|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-5.39|9.09|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||9.09|-5.39|
74053417|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.98|5.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||5.23|-5.98|
74053418|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|3.1|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-2.5|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||8.70|-2.50|
74053419|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|6.46|STANDARD_ERROR_OF_MEAN|2.14|||TWO_SIDED|95.0|2.02|10.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||10.89|2.02|
74053420|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|5.57|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|95.0|1.19|9.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||9.95|1.19|
74053421|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|3.63|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|0.34|6.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.91|0.34|
74053422|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|2.41|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-0.84|5.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.66|-0.84|
74053423|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|1.74|STANDARD_ERROR_OF_MEAN|2.23|||TWO_SIDED|95.0|-2.89|6.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||6.36|-2.89|
74053424|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|0.33|STANDARD_ERROR_OF_MEAN|2.25|||TWO_SIDED|95.0|-4.33|4.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||4.99|-4.33|
74053425|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|4.36|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|-1.17|9.88|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||9.88|-1.17|
74053426|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|5.41|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|95.0|-0.14|10.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||10.96|-0.14|
74053427|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|4.88|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|0.36|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||9.40|0.36|
74053428|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|-0.22|8.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||8.83|-0.22|
74053429|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|4.04|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-0.65|8.72|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||8.72|-0.65|
74053430|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|2.26|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.42|6.94|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||6.94|-2.42|
74053431|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|6.9|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|1.91|11.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||11.89|1.91|
74053432|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|6.15|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|1.22|11.08|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||11.08|1.22|
74053433|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|4.99|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|0.05|9.93|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||9.93|0.05|
74053434|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|5.34|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|0.45|10.22|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||10.22|0.45|
74053435|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|1.67|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-3.17|6.52|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.52|-3.17|
74053436|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|4.03|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|-0.86|8.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||8.92|-0.86|
74053437|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|4.05|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|95.0|-1.18|9.27|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||9.27|-1.18|
74053438|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|3.76|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-1.38|8.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||8.90|-1.38|
74053439|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|5.18|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-1.7|12.06|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||12.06|-1.70|
74053440|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|5.61|STANDARD_ERROR_OF_MEAN|3.25|||TWO_SIDED|95.0|-1.14|12.37|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||12.37|-1.14|
74053441|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|-0.21|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-5.35|4.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||4.92|-5.35|
74053442|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|1.61|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-3.42|6.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||6.65|-3.42|
74053443|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|5.08|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-1.19|11.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||11.36|-1.19|
74053444|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|5.3|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-0.83|11.42|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||11.42|-0.83|
74053445|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-4.02|6.63|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||6.63|-4.02|
74053446|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|2.93|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-2.26|8.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||8.12|-2.26|
74053447|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|-1.34|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-7.52|4.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.85|-7.52|
74053448|NCT03091920|147658201|OTHER|No statistical testing was performed.|Least squares mean difference|-1.14|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-7.25|4.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.98|-7.25|
74053449|NCT03091920|147658202|OTHER|No statistical testing was performed.|Least squares mean difference|-0.288|STANDARD_ERROR_OF_MEAN|0.274|||TWO_SIDED|95.0|-0.857|0.282|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.282|-0.857|
74053450|NCT03091920|147658202|OTHER|No statistical testing was performed.|Least squares mean difference|-0.105|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.708|0.498|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.498|-0.708|
74053451|NCT03091920|147658202|OTHER|No statistical testing was performed.|Least squares mean difference|-0.196|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|-0.727|0.335|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.335|-0.727|
74053452|NCT03091920|147658207|OTHER|No statistical testing was performed.|Least squares mean difference|-23.188|STANDARD_ERROR_OF_MEAN|27.97|||TWO_SIDED|95.0|-84.13|37.753|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||37.753|-84.130|
74053453|NCT03091920|147658207|OTHER|No statistical testing was performed.|Least squares mean difference|-14.033|STANDARD_ERROR_OF_MEAN|26.092|||TWO_SIDED|95.0|-70.883|42.817|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||42.817|-70.883|
74053454|NCT03091920|147658207|OTHER|No statistical testing was performed.|Least squares mean difference|-18.611|STANDARD_ERROR_OF_MEAN|24.138|||TWO_SIDED|95.0|-71.204|33.982|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||33.982|-71.204|
74053455|NCT03091920|147658207|OTHER|No statistical testing was performed.|Least squares mean difference|-25.389|STANDARD_ERROR_OF_MEAN|16.885|||TWO_SIDED|95.0|-62.551|11.774|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||11.774|-62.551|
74053456|NCT03091920|147658207|OTHER|No statistical testing was performed.|Least squares mean difference|-21.176|STANDARD_ERROR_OF_MEAN|16.221|||TWO_SIDED|95.0|-56.879|14.527|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||14.527|-56.879|
74053457|NCT03091920|147658207|OTHER|No statistical testing was performed.|Least squares mean difference|-23.282|STANDARD_ERROR_OF_MEAN|14.691|||TWO_SIDED|95.0|-55.618|9.053|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||9.053|-55.618|
74053458|NCT00453349|147658228|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 87% in the per protocol population"|Mean Difference (Final Values)|-3.2||||||95.0|-10.7|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||4.9|-10.7|
74099945|NCT00264550|147748970|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group 1 is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Assuming greater than 90 % power, ACR 20 response for Group I, Group III and Group IV (120, 80, and 80 participants, respectively) as 35 % for Group I and 55 % for Groups III and IV.||||<0.001
74099946|NCT00264550|147748970|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \& IV).||||0.001
74099947|NCT00264550|147748970|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \& IV).||||<0.001
74099948|NCT00264550|147748970|SUPERIORITY_OR_OTHER|||||||0.059||||||This null hypothesis is tested only if a positive test for null hypothesis Statistical Analysis 1.|Chi-squared|||Null hypothesis: No difference between Group II and Group I with respect of ACR 20 at Wk 14. Superiority of golimumab alone vs MTX alone will be demonstrated if 2-sided test is significant. Sample of 120 patients in each Group I \& II provides \>85% power assuming 35% ACR 20 response in Group I and 55% ACR 20 in Group II.||||0.059
73881599|NCT03192176|147297634|SUPERIORITY||LSMean difference|3.1|STANDARD_ERROR_OF_MEAN|6.16||0.613|TWO_SIDED|95.0|-9.02|15.26||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||15.26|-9.02|0.6130
74019456|NCT01070329|147591291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.75|-0.22||The P-value is for the main effect of treatment. The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||||-0.22|-0.75|<0.001
74053459|NCT00453349|147658229|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-1.9||||||95.0|-9.9|6.0|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.0|-9.9|
74053460|NCT00453349|147658230|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-3.2||||||95.0|-7.4|0.8|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||0.8|-7.4|
74053461|NCT00453349|147658231|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.5|-8.1|
74053462|NCT00453349|147658232|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|5.4||||||95.0|-12.7|20.3|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||20.3|-12.7|
74053463|NCT00453349|147658233|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|4.3||||||95.0|-19.4|17.6|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||17.6|-19.4|
74053464|NCT00453349|147658234|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-2.5||||||95.0|-8.6|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||4.9|-8.6|
74053465|NCT00453349|147658235|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.5|-8.1|
73888164|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|107.2||||0.0787|TWO_SIDED|95.0|-12.4|226.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||226.8|-12.4|0.0787
74019457|NCT01070329|147591292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.77|-2.62||The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||||-2.62|-5.77|<0.001
74053466|NCT00453349|147658236|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-7.9||||||95.0|-24.9|15.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||15.9|-24.9|
74053467|NCT00453349|147658237|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|3.7||||||95.0|-30.5|11.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||11.9|-30.5|
74053468|NCT01906489|147658262|SUPERIORITY||Odds Ratio (OR)|11.4739|||=|0.0001|TWO_SIDED|95.0|3.3505|39.2931|||Fisher Exact|||||39.2931|3.3505|=0.0001
74053469|NCT01906489|147658263|OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
74053470|NCT01906489|147658264|OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74053471|NCT01906489|147658266|OTHER||||||=|0.0953|TWO_SIDED||||||Fisher Exact|||||||=0.0953
74053472|NCT01906489|147658267|OTHER||||||=|0.1238|TWO_SIDED||||||Fisher Exact|||||||=0.1238
74099949|NCT00264550|147748971|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74053473|NCT01906489|147658268|OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
74053474|NCT01906489|147658269|OTHER||||||=|0.0019|||||||t-test, 2 sided|||Week 2||||=0.0019
74053475|NCT01906489|147658269|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
74053476|NCT01906489|147658269|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
74099950|NCT00264550|147748971|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
74053477|NCT01906489|147658269|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
74053478|NCT01906489|147658269|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
74053479|NCT01906489|147658269|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
74053480|NCT01906489|147658269|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
74053481|NCT01906489|147658269|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
74053482|NCT01906489|147658271|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 2||||<0.0001
74053483|NCT01906489|147658271|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
74053484|NCT01906489|147658271|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
74053485|NCT01906489|147658271|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
74053486|NCT01906489|147658271|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
74053487|NCT01906489|147658271|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
74053488|NCT01906489|147658271|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
74053489|NCT01906489|147658271|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
74053490|NCT01906489|147658273|OTHER||||||=|0.0031|||||||t-test, 2 sided|||Week 2||||=0.0031
74053491|NCT01906489|147658273|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
74053492|NCT01906489|147658273|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
74053493|NCT01906489|147658273|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
74053494|NCT01906489|147658273|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
74053495|NCT01906489|147658273|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
74053496|NCT01906489|147658273|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
74053497|NCT01906489|147658273|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
74053498|NCT01906489|147658275|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 2||||<0.0001
74053499|NCT01906489|147658275|OTHER||||||=|0.0133|||||||t-test, 2 sided|||Week 4||||=0.0133
74053500|NCT01906489|147658275|OTHER||||||=|0.3053|||||||t-test, 2 sided|||Week 6||||=0.3053
74053501|NCT01906489|147658275|OTHER||||||=|0.1918|||||||t-test, 2 sided|||Week 8||||=0.1918
74053502|NCT01906489|147658275|OTHER||||||=|0.209|||||||t-test, 2 sided|||Week 12||||=0.2090
74053503|NCT01906489|147658275|OTHER||||||=|0.6184|||||||t-test, 2 sided|||Week 16||||=0.6184
74053504|NCT01906489|147658275|OTHER||||||=|0.3604|||||||t-test, 2 sided|||Week 19||||=0.3604
74053505|NCT01906489|147658275|OTHER||||||=|0.4056|||||||t-test, 2 sided|||Week 20||||=0.4056
74053506|NCT01906489|147658281|OTHER||Hazard Ratio (HR)|4.1451|||=|0.0017|TWO_SIDED|95.0|1.5752|10.908|||Log Rank|||||10.9080|1.5752|=0.0017
74053507|NCT02361307|147658328|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
74053508|NCT01138995|147658329|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher's combination test|Between group difference for entire sample||||||0.75
74053509|NCT01138995|147658330|SUPERIORITY_OR_OTHER||||||<|0.022|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.022
74053510|NCT01138995|147658331|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74053511|NCT04259749|147658332|OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.58|3.4|||||Adjusted for age, education, lifetime use of tobacco products.|||3.40|0.58|
74053512|NCT04259749|147658332|OTHER||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|0.92|5.63|||||Adjusted for age, education, and lifetime use of tobacco products|||5.63|0.92|
74099951|NCT00264550|147748971|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74099952|NCT00264550|147748971|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||||||0.035
74099953|NCT00264550|147748972|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group I is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and Combined Golimumab + Methotrexate (MTX) at 0.05 level of significance.||||<0.001
74099954|NCT00264550|147748972|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and III at 0.05 level of significance.||||<0.001
74099955|NCT00264550|147748972|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and IV at 0.05 level of significance.||||<0.001
74099956|NCT00264550|147748972|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and II at 0.05 level of significance.||||0.240
74099957|NCT00264550|147748973|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74099958|NCT00264550|147748973|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74099959|NCT00264550|147748973|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73881600|NCT03192176|147297634|SUPERIORITY||LSMean difference|2.2|STANDARD_ERROR_OF_MEAN|6.22||0.7292|TWO_SIDED|95.0|-10.09|14.4||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||14.40|-10.09|0.7292
74099960|NCT00264550|147748973|SUPERIORITY_OR_OTHER|||||||0.187||95.0|||||Chi-squared|||||||0.187
74099961|NCT00264550|147748974|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden noramal|||||||<0.001
74099962|NCT00264550|147748974|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|||||||<0.001
74099963|NCT00264550|147748974|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|||||||<0.001
74099964|NCT00264550|147748974|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||ANOVA on van der Waerden normal scores|||||||0.097
74099965|NCT00264550|147748975|SUPERIORITY_OR_OTHER|||||||0.551|||||||ANOVA on van der Waerden normal|||||||0.551
74019458|NCT01070329|147591293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.47|-0.42||This is the p-value for the Disrupt Work/School Work score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.42|-1.47|<0.001
74019459|NCT01070329|147591293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.001|TWO_SIDED|95.0|-1.42|-0.53||This the p-value for the Disrupt Social Life/Leisure score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.53|-1.42|<0.001
74019460|NCT01070329|147591293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.41|-0.49||This is the p-value for the Disrupt Family Life/Home score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.49|-1.41|<0.001
74019461|NCT01070329|147591293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88|||<|0.001|TWO_SIDED|95.0|-4.16|-1.61||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-1.61|-4.16|<0.001
74019462|NCT01070329|147591294|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||<0.001
74019463|NCT01070329|147591295|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||This third gated secondary outcome measure failed to meet statistical significance. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes.|Cochran-Mantel-Haenszel|||||||0.173
74019464|NCT01070329|147591296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81|||||TWO_SIDED|95.0|-4.13|-1.48|||Mixed Models Analysis|Fourth gated secondary outcome measure. Statistical significance was not evaluated; prior gated secondary outcome measure failed (p\>0.05).||||-1.48|-4.13|
74019465|NCT01070329|147591297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67||||0.05|TWO_SIDED|95.0|0.0|3.34||This is the p-value for the Change at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.34|0.00|0.050
74019466|NCT01070329|147591297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.071|TWO_SIDED|95.0|-0.12|2.9||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori statistical significance was 0.05.|ANCOVA|||||2.90|-0.12|0.071
74019467|NCT01070329|147591298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91||||0.05|TWO_SIDED|95.0|0.0|3.82||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.82|0.00|0.050
74019468|NCT01070329|147591298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.007|TWO_SIDED|95.0|0.5|3.1||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.10|0.50|0.007
74019469|NCT01070329|147591298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.063|TWO_SIDED|95.0|-0.09|3.5||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.50|-0.09|0.063
74019470|NCT01070329|147591298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.004|TWO_SIDED|95.0|0.6|3.02||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.02|0.60|0.004
74019471|NCT01070329|147591299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|||||TWO_SIDED|95.0|-3.18|-0.96|||Mixed Models Analysis|Fifth gated secondary outcome measure. Statistical significance was not evaluated; the third gated secondary outcome measure failed (p\>0.05).||||-0.96|-3.18|
74019472|NCT01070329|147591300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.007|TWO_SIDED|95.0|-0.93|-0.15||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.93|0.007
74019473|NCT01070329|147591300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.002|TWO_SIDED|95.0|-0.93|-0.22||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||-0.22|-0.93|0.002
74053513|NCT04259749|147658333|OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.61|4.07|||||Adjusted for age, education, and lifetime use of tobacco products|||4.07|0.61|
74053514|NCT04259749|147658333|OTHER||Odds Ratio (OR)|3.45|||||TWO_SIDED|95.0|1.32|9.02|||||Adjusted for age, education, and lifetime use of tobacco products|||9.02|1.32|
74053515|NCT04259749|147658334|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.59|3.68|||||Adjusted for age, education, and lifetime use of tobacco|||3.68|.59|
74053516|NCT04259749|147658334|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.05|6.42|||||Adjusted for age, education, and lifetime use of tobacco products.|||6.42|1.05|
74053517|NCT04259749|147658335|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.47|2.49|||||Adjusted for age, education, and lifetime use of tobacco|||2.49|.47|
74053518|NCT04259749|147658335|OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|0.62|3.31|||||Adjusted for age, education, and lifetime use of tobacco products|||3.31|.62|
74053519|NCT04259749|147658336|OTHER||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.72|4.14|||||Adjusted for age, education, and lifetime use of tobacco products|||4.14|.72|
74053520|NCT04259749|147658336|OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.83|4.95|||||Adjusted for age, education, and lifetime use of tobacco products.|||4.95|.83|
74053521|NCT04259749|147658337|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.4|3.18|||||Adjusted for age, education, and lifetime tobacco use|||3.18|.40|
74053522|NCT04259749|147658337|OTHER||Odds Ratio (OR)|2.04|||||TWO_SIDED|95.0|0.73|5.71|||||Adjusted for age, education, and lifetime tobacco use|||5.71|.73|
74053523|NCT04259749|147658338|OTHER||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.66|4.75|||||Adjusted for age, education, and lifetime tobacco use|||4.75|.66|
74053524|NCT04259749|147658338|OTHER||Odds Ratio (OR)|3.06|||||TWO_SIDED|95.0|1.13|8.29|||||Adjusted for age, education, and lifetime use of tobacco|||8.29|1.13|
74053525|NCT04259749|147658339|OTHER||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.51|3.7|||||Adjusted for age, education, and lifetime tobacco use|||3.70|.51|
74053526|NCT04259749|147658339|OTHER||Odds Ratio (OR)|2.32|||||TWO_SIDED|95.0|0.85|6.31|||||Adjusted for age, education, and lifetime tobacco use|||6.31|.85|
74053527|NCT04259749|147658340|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.29|4.26|||||Adjusted for age, education, and lifetime tobacco use|||4.26|.29|
74053528|NCT04259749|147658340|OTHER||Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.57|7.06|||||Adjusted for age, education, and lifetime tobacco use|||7.06|.57|
74099966|NCT00264550|147748975|SUPERIORITY_OR_OTHER|||||||0.953|||||||ANOVA on van der Waerden normal scores|||||||0.953
74053529|NCT04259749|147658341|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.33|3.31|||||Adjusted for age, education, and lifetime tobacco use|||3.31|.33|
74053530|NCT04259749|147658341|OTHER||Odds Ratio (OR)|2.43|||||TWO_SIDED|0.95|0.83|7.13|||||Adjusted for age, education, and lifetime tobacco use|||7.13|.83|
74053531|NCT04259749|147658342|OTHER||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.72|4.14|||||Adjusted for age, education, and lifetime tobacco use|||4.14|.72|
74053532|NCT04259749|147658342|OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.83|4.95|||||Adjusted for age, education, and lifetime tobacco use|||4.95|.83|
74053533|NCT00303602|147658343|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||P-value for Week 2 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.428
74053534|NCT00303602|147658343|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||P-value for Week 4 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.859
74053535|NCT00303602|147658343|SUPERIORITY_OR_OTHER|||||||0.885||95.0||||P-value for Week 8 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.885
74053536|NCT00303602|147658343|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-value for Week 12 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.784
74053537|NCT00303602|147658343|SUPERIORITY_OR_OTHER|||||||0.465||95.0||||P-value for Week 16 Change from Baseline. There was no adjustment for multiple comparisons|Mixed Models Analysis|||||||0.465
74053538|NCT00303602|147658344|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|-0.19||||0.442||95.0|-0.67|0.3|||ANCOVA||Change = Endpoint minus baseline|||0.30|-0.67|0.442
74053539|NCT00303602|147658345|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|-0.32||||0.328||95.0|-0.95|0.32|||ANCOVA||Change = Endpoint minus baseline|||0.32|-0.95|0.328
74053540|NCT00303602|147658346|SUPERIORITY_OR_OTHER|||||||0.385||95.0|||||Mixed Models Analysis|||||||0.385
74053541|NCT00303602|147658347|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|0.1||||0.914||95.0|-1.65|1.84|||ANCOVA||Change = endpoint minus baseline|||1.84|-1.65|0.914
74053542|NCT00303602|147658348|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||Up to Week 16 p-value|Fisher Exact|||||||0.325
74053543|NCT00303602|147658350|SUPERIORITY_OR_OTHER|||||||0.344||95.0|||||Mixed Models Analysis|||||||0.344
74053544|NCT00303602|147658351|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||Systolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test|||||||0.708
74053545|NCT00303602|147658351|SUPERIORITY_OR_OTHER|||||||0.453||95.0||||Diastolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test|||||||0.453
74053546|NCT00303602|147658352|SUPERIORITY_OR_OTHER|||||||0.187||95.0||||Total Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.187
74053547|NCT00303602|147658352|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||High-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.163
74053548|NCT00303602|147658352|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||Low-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.323
74053549|NCT00303602|147658352|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Triglycerides Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.581
74099967|NCT00264550|147748975|SUPERIORITY_OR_OTHER|||||||0.293|||||||ANOVA on van der waerden normal scores|||||||0.293
74099968|NCT00264550|147748975|SUPERIORITY_OR_OTHER|||||||0.361|||||||ANOVA on van der Waerden normal scores|||||||0.361
74099969|NCT01917214|147748978|SUPERIORITY_OR_OTHER|||||||0.0308|||||||Log Rank|||||||0.0308
74099970|NCT00696787|147748997|SUPERIORITY_OR_OTHER||Adjusted mean|-0.38||||0.471|TWO_SIDED|95.0|-1.42|0.66|||ANCOVA|||||0.66|-1.42|0.471
74099971|NCT00696787|147748997|SUPERIORITY_OR_OTHER||Adjusted mean|-0.28||||0.604|TWO_SIDED|95.0|-1.33|0.77|||ANCOVA|||||0.77|-1.33|0.604
74099972|NCT00696787|147748998|SUPERIORITY_OR_OTHER||Adjusted mean|-0.35||||0.51|TWO_SIDED|95.0|-1.42|0.71|||ANCOVA|||||0.71|-1.42|0.510
74053550|NCT00303602|147658353|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.227
74053551|NCT00303602|147658354|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.020
74053552|NCT00303602|147658355|SUPERIORITY_OR_OTHER|||||||0.834||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.834
74053553|NCT00303602|147658356|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals on this regression in CMH test.||||||0.022
74099973|NCT00696787|147748998|SUPERIORITY_OR_OTHER||Adjusted mean|-0.55||||0.317|TWO_SIDED|95.0|-1.64|0.54|||ANCOVA|||||0.54|-1.64|0.317
74099974|NCT01549405|147749010|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mann-Whitney U test|||||||0.002
74099975|NCT01549405|147749011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.1|STANDARD_DEVIATION|58.0||0|TWO_SIDED|95.0|52.98|132.4|||t-test, 2 sided|||||132.4|52.98|0.000
74099976|NCT02814890|147749017|OTHER|difference test||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Sample size: Based on our previous data, pain score at rest 48 hours postoperatively when using ropivacaine only was of 2.8 with a standard deviation of 1.4. Assuming a decrease of pain score by 1.1 being clinically significant, twenty six patents in each group would be required for a study power of 80% (α=0.05,β=0.2). Considering possible dropouts, we aimed at recruiting 30 patients in each group with a total of 60 patients.||||0.001
74053554|NCT00303602|147658357|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||Endpoint Metabolic Syndrome p-value|Fisher Exact|||||||0.515
74053555|NCT00303602|147658358|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||Mixed Models Analysis|||||||0.118
74053556|NCT00303602|147658359|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Mixed Models Analysis|||||||0.161
74053557|NCT00303602|147658360|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Mixed Models Analysis|||||||0.229
74053558|NCT00313716|147658361|SUPERIORITY_OR_OTHER|||||||0.01||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo2 group - in Placebo group is \>= 0.2.~H1: Proportion in Epo2 group - in Placebo group \< 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 2 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups. Using a one-sided alpha of 0.15, a sample size of 62 subjects in the Epo 2 regimen group and 100 subjects in the placebo group provided 91% power to test the futility hypothesis.||||.01
74053559|NCT00313716|147658361|SUPERIORITY_OR_OTHER|||||||0.13||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo1 group - in Placebo group is \>= 0.2.~H1: Proportion in Epo1 group - in Placebo group \< 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 1 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups.||||0.13
74053560|NCT00313716|147658361|SUPERIORITY_OR_OTHER|||||||0.34|||||||2-sample test of proportions|||We hypothesized that 40% of the patients in the TT7 group would have a favorable GOS score and that there would be no interaction between the Epo and TT groups. Assuming a 2-sided test with an alpha level of 0.05, we estimated that a sample size of 200 patients would provide 80% power to detect a 20% absolute increase in the GOS score for the TT10 group.||||.34
74053561|NCT00313716|147658362|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
74053562|NCT00313716|147658363|SUPERIORITY_OR_OTHER|||||||0.25|||||||Log Rank|||||||.25
74053563|NCT00313716|147658363|SUPERIORITY_OR_OTHER|||||||0.75|||||||Log Rank|||||||.75
74053564|NCT00313716|147658363|SUPERIORITY_OR_OTHER|||||||0.72|||||||Log Rank|||||||.72
74053565|NCT00313716|147658364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79||||0.08|TWO_SIDED|95.0|0.93|3.45|||Regression, Cox|||||3.45|.93|.08
74053566|NCT00313716|147658365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.26|TWO_SIDED|95.0|-0.22|0.05|||2-sample test - equality of proportions|||||.05|-.22|.26
74099977|NCT02814890|147749018|OTHER|difference test|Kendall's tau-b correlation coefficient|0.47|||||TWO_SIDED|||||||||||||
74099978|NCT02814890|147749020|SUPERIORITY||Risk Ratio (RR)|0.64|||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
74099979|NCT02052011|147749028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|||||TWO_SIDED|95.0|-0.08|0.62||||||||0.62|-0.08|
74099980|NCT00000620|147749029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.12|TWO_SIDED|95.0|0.81|1.03||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.||1.03|0.81|0.12
74099981|NCT00000620|147749030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.02|TWO_SIDED|95.0|1.03|1.38||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.||1.38|1.03|0.02
74053567|NCT01249404|147658397|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-0.1|||=|0.2859|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.1|-0.3|=0.2859
74053568|NCT01249404|147658397|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|||=|0.0091|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||-0.1|-0.5|=0.0091
74053569|NCT01249404|147658398|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|||=|0.064|TWO_SIDED|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.5|-0.0|=0.0640
74053570|NCT01249404|147658398|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|||=|0.0665|TWO_SIDED|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.5|-0.0|=0.0665
74053571|NCT01249404|147658398|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.0466|TWO_SIDED||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.||||0.0466
74053572|NCT01249404|147658398|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.0406|TWO_SIDED||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.||||0.0406
74053573|NCT01249404|147658399|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|||=|0.7247|TWO_SIDED|95.0|-0.02|0.03|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.03|-0.02|=0.7247
74053574|NCT01249404|147658399|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|||=|0.7266|TWO_SIDED|95.0|-0.03|0.02|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.02|-0.03|=0.7266
74053575|NCT03287960|147658452|OTHER|Two-sided confidence interval obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest will achieve 10% weight loss.||||||0.0001|||||||Clopper-Pearson method|||||||0.0001
74053576|NCT03287960|147658453|OTHER|Two-sided confidence interval (CI) obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that at least 5% of patients in the population of interest would achieve 10% weight loss.|||||<|0.0001|||||||Clopper-Pearson method|||||||<0.0001
74053577|NCT03287960|147658454|OTHER|Model based summary statistics from longitudinal mixed analysis of variance (ANOVA) model with fixed effect for visit, baseline body weight and random effect for participant, one sided p-value from model.|Least Squares Mean|-12.37|||<|0.0001|TWO_SIDED|90.0|-15.08|-9.66|||ANOVA|Longitudinal mixed ANOVA||||-9.66|-15.08|<.0001
74053578|NCT03287960|147658455|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline daily hunger score and random effect for participant, one sided p-value from model.|Least Squares Mean|-42.69|||<|0.0001|TWO_SIDED|90.0|-56.35|-29.02|||ANOVA|Longitudinal mixed analysis of variance (ANOVA) model||||-29.02|-56.35|<.0001
74053579|NCT03287960|147658456|OTHER|Two-sided CI obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that ≥5 % of participants in the population of interest would achieve ≥25 % improvement in daily hunger score.|||||<|0.0001|||||||Clopper-Pearson method|||||||<.0001
74053580|NCT03287960|147658457|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline waist circumference and random effect for participant, one sided p-value from model.|Least Squares Mean|-8.9||||0.0031|TWO_SIDED|90.0|-14.1|-3.61|||ANOVA|Longitudinal mixed ANOVA||||-3.61|-14.10|0.0031
74053581|NCT03287960|147658460|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline BMI and random effect for participant, one sided p-value from model.|Least Squares Mean|-14.0|||<|0.0001|TWO_SIDED|90.0|-16.8|-11.2|||ANOVA|Longitudinal mixed ANOVA model||||-11.20|-16.80|<.0001
74053582|NCT02600715|147658469|EQUIVALENCE|Test for differences in continuous variables.||||||0.94||||||Two-sided alpha of 0.05 was used to determine statistical significance.|Kruskal-Wallis|||||||0.94
74053583|NCT01425268|147658499|NON_INFERIORITY|Assuming that the success rate for both expanders was 95%, at least 92 breasts implanted with a AeroForm Tissue Expander and 46 breasts implanted with a saline expander were needed to be 80% confident (i.e., have a statistical power of 80%) that the lower bound of the one-sided 95% Confidence Interval for the difference in the Success rates (πTreatment - πControl) was greater than or equal to -10%.|margin of non-inferiority|-7.3|||||ONE_SIDED|95.0|-7.3241||||||The Treatment Success Rate per breast is 96.1% (149/155) for AeroForm and 98.8% (82/83) for saline.The difference (AeroForm - saline) is -2.7% with a lower confidence limit of -7.3%, meeting the non-inferiority margin of \> -10%.|The study was powered to show that the Treatment Success rate for the AeroForm System (πTreatment) was not worse than the rate for the saline expander (πControl) by more than 10% (-0.10 \< πTreatment - πControl).|||-7.3241|
74053584|NCT01425268|147658500|SUPERIORITY||||||<|0.0001|||||||Kaplan-Meier Log Rank test|Subjects not completing tissue expansion are censored in the analysis||||||<0.0001
74053585|NCT02839330|147658501|EQUIVALENCE|Equivalence margin: The 2-sided 95% confidence interval (CI) of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.13||||||aH5N1c Lot #1 vs. aH5N1c Lot #2||1.13|0.90|
74053586|NCT02839330|147658501|EQUIVALENCE|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.96|||||TWO_SIDED|95.0|0.86|1.08||||||aH5N1c Lot #2 vs. aH5N1c Lot #3||1.08|0.86|
74053587|NCT02839330|147658501|EQUIVALENCE|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.97|||||TWO_SIDED|95.0|0.87|1.09||||||aH5N1c Lot #1 vs. aH5N1c Lot #3||1.09|0.87|
74099982|NCT00000620|147749031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.2|TWO_SIDED|95.0|0.73|1.06||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Blood PressureTrial was designed to enroll 4200 participant to have 94% power to detect a 20% reduction in the rate of MCE for patients in the intensive-therapy group as compared with the standard-therapy group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 4% per year in the standard-therapy group, and a planned average follow-up of approximately 5.6 years.||1.06|0.73|0.20
74053588|NCT02615158|147658513|EQUIVALENCE|If the 95% confidence interval of the difference in the change over time does not include 0, it means that there is a significant difference in the change over time between the two groups.|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.555|TWO_SIDED|95.0|-0.17|0.31||The alpha for statistical significance is set at 0.05.|Mixed Models Analysis||This is to compare change in maternal lifestyle group to child safety group.|H0: There are no differences between the maternal lifestyle and child safety groups in the change in BMI z-score over time. Mixed models included the interaction between time and intervention, accounting for clustering of the repeated measures within each individual.||0.31|-0.17|0.555
74053589|NCT02615158|147658513|EQUIVALENCE|95% CI|Slope|0.16|STANDARD_ERROR_OF_MEAN|0.12||0.2|TWO_SIDED|95.0|-0.08|0.39||Two-side test|Mixed Models Analysis||This is to compare the Responsive Parenting to the safety intervention group.|||0.39|-0.08|0.200
74099983|NCT00000620|147749032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.01|TWO_SIDED|95.0|0.39|0.89||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||||0.89|0.39|0.01
74053590|NCT02615158|147658514|EQUIVALENCE|95% confidence interval (CI) was estimated. If the 95% CI does not include 0, it means there is significant difference in the change over time between the two groups.|Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.32||0.739|TWO_SIDED|95.0|-0.74|0.52||The alpha for statistical significance is set at 0.05|Mixed Models Analysis||This is to compare maternal lifestyle to child safety group.|H0: There is no difference between maternal lifestyle and child safety groups in the change of BMI over time.||0.52|-0.74|0.739
74053591|NCT02615158|147658514|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it means that there is a statistically significant difference in the change over time between the two groups.|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.32||0.904|TWO_SIDED|95.0|-0.66|0.59||The alpha for statistical significance was set at 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to the child safety group.|H0: There are no differences in the change over time between responsive parenting and child safety groups.||0.59|-0.66|0.904
74053592|NCT02615158|147658515|EQUIVALENCE|The 95% confidence interval (CI) for the difference in the change over time was estimated. If it does not include 0, it indicates significant difference in the change over time.|Slope|3.31|STANDARD_ERROR_OF_MEAN|2.4||0.168|TWO_SIDED|95.0|-1.4|8.02||Alpha is set at 0.05.|Mixed Models Analysis|||H0 is that there is no difference between maternal lifestyle and child safety groups in the change of HEI 2015 score over time.||8.02|-1.4|0.168
74053593|NCT02615158|147658515|EQUIVALENCE|95% CI was estimated. If it does not include 0, it indicates that there is a significant difference in the change between the two groups.|Slope|0.82|STANDARD_ERROR_OF_MEAN|2.39||0.733|TWO_SIDED|95.0|-3.88|5.52|||Mixed Models Analysis||This is to compare the responsive feeding group to child safety group.|H0 is that there is no difference between the responsive parenting and child safety groups in the change of HEI score over time||5.52|-3.88|0.733
74053594|NCT02615158|147658516|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is significant difference in the change over time between the two groups.|Slope|3.3|STANDARD_ERROR_OF_MEAN|2.49||0.186|TWO_SIDED|95.0|-1.6|8.2||Alpha is set at 0.05.|Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|Null hypothesis is that there are no differences between the two groups regarding the change of HEI 2015 score over time.||8.2|-1.6|0.186
74053595|NCT02615158|147658516|EQUIVALENCE|95% CI for the difference in change over time was estimated. If it does not include 0, it indicates that there is significant difference between the two groups.|Slope|-0.03|STANDARD_ERROR_OF_MEAN|2.51||0.99|TWO_SIDED|95.0|-4.97|4.91||Alpha is set to 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.|H0 is there is no difference in the change of maternal HEI score over time between the two groups.||4.91|-4.97|0.990
74053596|NCT02615158|147658517|EQUIVALENCE|A 95% CI was estimated. If it does not include 0, it indicates significant difference in change over time between the two groups.|Slope|23.67|STANDARD_ERROR_OF_MEAN|11.03||0.034|TWO_SIDED|95.0|1.88|45.46||Alpha is set at 0.05.|Mixed Models Analysis||This is for maternal lifestyle group compared to safety control group.|Null hypothesis is there were no differences in the change over time for toddler MVPA across the two groups.||45.46|1.88|0.034
74053597|NCT02615158|147658517|EQUIVALENCE|H0 is that there is no difference between the change of MVPA over time between the two groups.|Slope|13.52|STANDARD_ERROR_OF_MEAN|10.89||0.216|TWO_SIDED|95.0|-7.98|35.03|||Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.|||35.03|-7.98|0.216
74053598|NCT02615158|147658518|EQUIVALENCE|The 95% CI for the difference in the change between the two groups was estimated. If it does not include 0, it indicates that there is a significant difference by group in the change.|Slope|10.97|STANDARD_ERROR_OF_MEAN|4.82||0.024|TWO_SIDED|95.0|1.46|20.48|||Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|H0 is that there is no difference in the change of maternal MVPA over time between the two groups.||20.48|1.46|0.024
74053599|NCT02615158|147658518|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|0.98|STANDARD_ERROR_OF_MEAN|4.94||0.804|TWO_SIDED|95.0|-8.76|10.72|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|H0 is that there is no significant difference in the change of maternal MVPA between the two groups.||10.72|-8.76|0.804
74053600|NCT02615158|147658519|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.056|TWO_SIDED|95.0|-0.78|0.06||Alpha is set at 0.05 for statistical significance.|Mixed Models Analysis||This is to compare maternal lifestyle group to the child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.||0.06|-0.78|0.056
74053601|NCT02615158|147658519|EQUIVALENCE|Alpha is set at 0.05 to indicate statistical significance.|Slope|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.896|TWO_SIDED|95.0|-0.39|0.45|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.||0.45|-0.39|0.896
74053602|NCT02257970|147658521|EQUIVALENCE|The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||<|0.0001|||||||t-test, 2 sided|paired t-test||For the analysis, the 4-month post-minus-pre change in this score for ketoprofen was compared.||||<0.0001
74053603|NCT02257970|147658522|EQUIVALENCE|Pre-to-post comparison: the likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||=|0.6|||||||t-test, 2 sided|Paired t-test||||||=0.6
74053604|NCT02257970|147658522|EQUIVALENCE|Pre-to-Post comparison: The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||=|0.01|||||||t-test, 2 sided|paired t-test||||||=0.01
74053605|NCT00883896|147658535|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-5.9||||0.558|TWO_SIDED|95.0|-25.0|13.3|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided Cochran-Mantel-Haenszel (CMH) test stratified by anti-tumor necrosis factor (anti-TNF) prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||13.3|-25.0|0.558
74053606|NCT00883896|147658535|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-11.4||||0.251|TWO_SIDED|95.0|-30.1|7.3|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.3|-30.1|0.251
74053607|NCT00883896|147658535|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.7||||0.707|TWO_SIDED|95.0|-21.7|14.4|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.4|-21.7|0.707
74053608|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.1||||0.991|TWO_SIDED|95.0|-14.8|14.7|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.7|-14.8|0.991
74053609|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-4.8||||0.518|TWO_SIDED|95.0|-18.4|8.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||8.8|-18.4|0.518
74053610|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Perecent Difference|0.781||||0.63|TWO_SIDED|95.0|-16.9|9.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.8|-16.9|0.630
74053611|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|9.4||||0.295|TWO_SIDED|95.0|-8.3|27.0|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||27.0|-8.3|0.295
74053612|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Perecent Difference|-3.4||||0.686|TWO_SIDED|95.0|-19.3|12.5|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||12.5|-19.3|0.686
74053613|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.772|TWO_SIDED|95.0|-13.2|18.2|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.2|-13.2|0.772
74053614|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|12.8||||0.201|TWO_SIDED|95.0|-6.5|32.0|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||32.0|-6.5|0.201
74099984|NCT00000620|147749033|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.32|TWO_SIDED|95.0|0.79|1.08||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Glycemia Trial was designed to enroll 5800 participant to have 87% power to detect a 20% reduction in the rate of MCE for patients in the fenofibrate group as compared with the placebo group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 2.4% per year in the placebo group, and a planned average follow-up of approximately 5.6 years.||1.08|0.79|0.32
74099985|NCT00000620|147749034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.3|TWO_SIDED|95.0|0.85|1.05||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||||1.05|0.85|0.30
74099986|NCT02960490|147749042|SUPERIORITY||Difference from Placebo|-4.7||||0.621|TWO_SIDED|95.0|-25.85|16.46|||Regression, Logistic|||||16.46|-25.85|0.621
74053615|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-10.4||||0.256|TWO_SIDED|95.0|-27.3|6.5|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.5|-27.3|0.256
74053616|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|6.1||||0.519|TWO_SIDED|95.0|-11.4|23.5|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||23.5|-11.4|0.519
74053617|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|16.7||||0.094|TWO_SIDED|95.0|-1.9|35.2|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||35.2|-1.9|0.094
74099987|NCT02667067|147749063|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
74099988|NCT01333397|147749087|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 20 U Vs Placebo||||<0.0001
74053618|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.8||||0.76|TWO_SIDED|95.0|-14.4|20.1|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||20.1|-14.4|0.760
74053619|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.6||||0.95|TWO_SIDED|95.0|-16.8|18.0|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.0|-16.8|0.950
74053620|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|13.6||||0.185|TWO_SIDED|95.0|-5.9|33.0|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||33.0|-5.9|0.185
74053621|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.2||||0.982|TWO_SIDED|95.0|-18.8|19.3|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||19.3|-18.8|0.982
74099989|NCT01333397|147749087|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 50 U Vs Placebo||||<0.0001
74099990|NCT01333397|147749087|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 75 U Vs Placebo||||<0.0001
74099991|NCT01333397|147749087|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 20 U Vs Placebo||||<0.0001
74099992|NCT01333397|147749087|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 50 U Vs Placebo||||<0.0001
74099993|NCT01333397|147749087|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 75 U Vs Placebo||||<0.0001
74099994|NCT02892149|147749124|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.23|-0.1||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.10|-0.23|
74053622|NCT00883896|147658536|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-11.6||||0.223|TWO_SIDED|95.0|-29.0|5.8|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.8|-29.0|0.223
74053623|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.5||||0.885|TWO_SIDED|95.0|-6.8|5.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.8|-6.8|0.885
74053624|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|6.1||||0.18|TWO_SIDED|95.0|-3.4|15.6|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||15.6|-3.4|0.180
74053625|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-2.7||||0.277|TWO_SIDED|95.0|-6.5|1.1|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||1.1|-6.5|0.277
74053626|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|1.7||||0.74|TWO_SIDED|95.0|-7.9|11.3|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.3|-7.9|0.740
74099995|NCT02892149|147749125|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.30 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|0.96||||0.4745|TWO_SIDED|95.0|0.828|1.117|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.117|0.828|0.4745
74053627|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.4||||0.934|TWO_SIDED|95.0|-9.3|10.1|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||10.1|-9.3|0.934
74053628|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.6||||0.876|TWO_SIDED|95.0|-7.7|6.4|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.4|-7.7|0.876
74053629|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.1||||0.842|TWO_SIDED|95.0|-11.4|9.2|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.2|-11.4|0.842
74053630|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.1||||0.509|TWO_SIDED|95.0|-8.1|16.3|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||16.3|-8.1|0.509
74053631|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.0||||0.504|TWO_SIDED|95.0|-7.0|15.0|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||15.0|-7.0|0.504
74053632|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.4||||0.373|TWO_SIDED|95.0|-6.3|17.0|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||17.0|-6.3|0.373
74099996|NCT02892149|147749125|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4877|TWO_SIDED|95.0|0.833|1.113|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 355 and 377 respectively; median time to first event (Q1, Q3) = 46.14 (24.71, 77.14) weeks versus 47.00 (22.43, 74.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.113|0.833|=0.4877
74099997|NCT02892149|147749126|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.25|-0.12||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.12|-0.25|
74099998|NCT02892149|147749127|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.3718|TWO_SIDED|95.0|0.832|1.097|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.097|0.832|0.3718
74053633|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.4||||0.499|TWO_SIDED|95.0|-12.0|5.2|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.2|-12.0|0.499
74099999|NCT02892149|147749127|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4096|TWO_SIDED|95.0|0.84|1.096|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE plus hospitalization for heart failure or thromboembolic event Excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 420 and 449 respectively; median time to first event (Q1, Q3) = 42.07 (21.50, 71.14) weeks versus 45.29 (22.29, 72.43) weeks, respectively.||1.096|0.840|=0.4096
74100000|NCT02892149|147749128|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.94||||0.3875|TWO_SIDED|95.0|0.777|1.131|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.131|0.777|0.3875
74100001|NCT02892149|147749128|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.5007|TWO_SIDED|95.0|0.795|1.144|||Gray's test|||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 225 and 242 respectively; median time to first event (Q1, Q3) = 43.29 (21.71, 77.14) weeks versus 45.79 (21.14, 73.86) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.144|0.795|=0.5007
74100002|NCT02892149|147749129|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.6281|TWO_SIDED|95.0|0.761|1.203|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.203|0.761|0.6281
74100003|NCT02892149|147749129|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.6284|TWO_SIDED|95.0|0.766|1.195|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 150 and 160 respectively; median time to first event (Q1, Q3) = 43.71 (27.43, 77.14) weeks versus 49.29 (24.43, 74.07) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.195|0.766|=0.6284
74100004|NCT02892149|147749130|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.5811|TWO_SIDED|95.0|0.816|1.136|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.136|0.816|0.5811
74100005|NCT02892149|147749130|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.4878|TWO_SIDED|95.0|0.812|1.118|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 291 and 310 respectively; median time to first event (Q1, Q3) = 50.00 (29.71, 79.00) weeks versus 49.57 (25.86, 77.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.118|0.812|=0.4878
74100006|NCT00384930|147749161|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus Baseline.|Permutation Test|||This is the principal inferential analysis of the primary outcome.||||<0.001
74100007|NCT00384930|147749162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.025||95.0|-1.08|-0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.07|-1.08|0.025
74100008|NCT00384930|147749162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.001||95.0|-1.4|-0.4||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.40|-1.40|<0.001
74100009|NCT00384930|147749162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.96|||<|0.001||95.0|-1.45|-0.46||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.46|-1.45|<0.001
74100010|NCT00384930|147749162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||<|0.001||95.0|-1.58|-0.57||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.57|-1.58|<0.001
74100011|NCT00384930|147749163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.008||95.0|-1.69|-0.26||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.26|-1.69|0.008
74100012|NCT00384930|147749163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69|||<|0.001||95.0|-2.4|-0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.98|-2.40|<0.001
74100013|NCT00384930|147749163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89|||<|0.001||95.0|-2.6|-1.18||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-1.18|-2.60|<0.001
74019474|NCT01070329|147591301|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.021
74019475|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.85|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.27|-0.85|<0.001
74019476|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.003|TWO_SIDED|95.0|-0.64|-0.13||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.13|-0.64|0.003
74019477|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.75|-0.22||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.22|-0.75|<0.001
74019478|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.86|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.27|-0.86|<0.001
74019479|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.008|TWO_SIDED|95.0|-0.75|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.11|-0.75|0.008
74019480|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.004|TWO_SIDED|95.0|-0.8|-0.15||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.80|0.004
74019481|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.006|TWO_SIDED|95.0|-0.72|-0.12||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability Score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.12|-0.72|0.006
74019482|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.012|TWO_SIDED|95.0|-0.72|-0.09||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.09|-0.72|0.012
74019483|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.029|TWO_SIDED|95.0|-0.7|-0.04||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.04|-0.70|0.029
74019484|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.037|TWO_SIDED|95.0|-0.75|-0.02||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.02|-0.75|0.037
74019485|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.006|TWO_SIDED|95.0|-0.81|-0.14||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.14|-0.81|0.006
74019486|NCT01070329|147591302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.004|TWO_SIDED|95.0|-0.74|-0.15||This is the p-value for the main effect of treatment for the BPI Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.74|0.004
74019487|NCT01070329|147591303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.49||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.49|-0.90|<0.001
74019488|NCT01070329|147591304|SUPERIORITY_OR_OTHER|||||||0.116||95.0||||This is the p-value for Suicidal Ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.116
74019489|NCT06062264|147591316|SUPERIORITY||Adjusted Risk Ratio|1.03|||||TWO_SIDED|95.0|1.0|1.06||||||Comparing the risk of receiving an influenza vaccination|Adjusted risk ratio. These results compare arms which received portal-based PCP video reminder messages to the arm receiving standard health system portal messages (control).|1.06|1.00|
74019490|NCT06062264|147591316|SUPERIORITY||Adjusted Risk Ratio|1.02|||||TWO_SIDED|95.0|0.99|1.06|||||Adjusted risk ratio. These results compare arms which received portal-based PCP video reminder messages to the arm receiving standard health system portal messages (control).|Comparing the risk of receiving an influenza vaccination||1.06|0.99|
74019491|NCT02522767|147591321|SUPERIORITY||Odds Ratio (OR)|1.55|||>|0.05|TWO_SIDED|95.0|0.73|3.32||The p-value was based on chi-square test without a continuity correction.|Chi-squared|||Proportions were compared between treatment groups, at a two-sided 0.05 significance level.||3.32|0.73|>0.05
74019492|NCT02522767|147591324|SUPERIORITY||Odds Ratio (OR)|1.78|||>|0.05|TWO_SIDED|95.0|0.96|3.29||The p-value was based on chi-square test without a continuity correction.|Chi-squared|||Proportions were compared between treatment groups at a two-sided 0.05 significance level.||3.29|0.96|>0.05
74019493|NCT02522767|147591325|SUPERIORITY||Odds Ratio (OR)|1.3|||>|0.05|TWO_SIDED|95.0|0.78|2.15|||Generalized estimating equation approach|||Proportions were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||2.15|0.78|>0.05
74019494|NCT02522767|147591326|SUPERIORITY||Hazard Ratio (HR)|1.36|||>|0.05|TWO_SIDED|95.0|0.91|2.02||The p-value was based on log-rank test.|Log Rank||Hazard ratio and its 95% CI were obtained from Cox proportional hazards model with treatment group as a factor.|Times to normal stool pattern were compared between treatment groups, at a two-sided 0.05 significance level.||2.02|0.91|>0.05
74100014|NCT00384930|147749163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.87|||<|0.001||95.0|-2.59|-1.15||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-1.15|-2.59|<0.001
74100015|NCT00384930|147749164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.503||95.0|-0.28|0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.14|-0.28|0.503
74100016|NCT00384930|147749164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.206||95.0|-0.34|0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||0.07|-0.34|0.206
74100017|NCT00384930|147749164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.452||95.0|-0.28|0.13||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||0.13|-0.28|0.452
74100018|NCT00384930|147749164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.012||95.0|-0.47|-0.06||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.06|-0.47|0.012
74100019|NCT00384930|147749165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.029||95.0|-0.49|-0.03||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.03|-0.49|0.029
74100020|NCT00384930|147749165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.002||95.0|-0.6|-0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.14|-0.60|0.002
74100021|NCT00384930|147749165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43|||<|0.001||95.0|-0.66|-0.19||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.19|-0.66|<0.001
74100022|NCT00384930|147749165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|||<|0.001||95.0|-0.64|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.17|-0.64|<0.001
74100023|NCT00384930|147749166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.583||95.0|-0.58|0.33||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.33|-0.58|0.583
74100024|NCT00384930|147749166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.013||95.0|-1.03|-0.12||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.12|-1.03|0.013
74100025|NCT00384930|147749166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.016||95.0|-1.0|-0.1||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.10|-1.00|0.016
74100026|NCT00384930|147749166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.007||95.0|-1.08|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.17|-1.08|0.007
74100027|NCT00384930|147749167|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.133
74100028|NCT00384930|147749167|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.003
74100029|NCT00384930|147749167|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||<0.001
74100030|NCT00384930|147749167|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||<0.001
74100031|NCT00384930|147749168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.735||95.0|-0.69|0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.98|-0.69|0.735
74100032|NCT00384930|147749168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.355||95.0|-0.44|1.23||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||1.23|-0.44|0.355
73881601|NCT03192176|147297634|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|5.6||0.8695|TWO_SIDED|95.0|-1.11|11.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||11.96|-1.11|0.8695
74053634|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|7.0||||0.244|TWO_SIDED|95.0|-4.2|18.3|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.3|-4.2|0.244
74053635|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.2||||0.979|TWO_SIDED|95.0|-15.0|14.6|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.6|-15.0|0.979
74053636|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-9.8||||0.166|TWO_SIDED|95.0|-21.8|2.2|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||2.2|-21.8|0.166
74053637|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.5||||0.947|TWO_SIDED|95.0|-13.2|14.2|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.2|-13.2|0.947
74053638|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|8.3||||0.286|TWO_SIDED|95.0|-7.1|23.8|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||23.8|-7.1|0.286
74053639|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.6||||0.822|TWO_SIDED|95.0|-15.0|11.8|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.8|-15.0|0.822
74053640|NCT00883896|147658537|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.1||||0.986|TWO_SIDED|95.0|-12.3|12.1|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||12.1|-12.3|0.986
74053641|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
74053642|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.188|TWO_SIDED|95.0|-2.3|7.3|||Cochran-Mantel-Haenszel|||Week 2:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.3|-2.3|0.188
74100033|NCT00384930|147749168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.433||95.0|-0.5|1.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||1.17|-0.50|0.433
74053643|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 2: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||0.0|0.0|
74100034|NCT00384930|147749168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.089||95.0|-0.11|1.59||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||1.59|-0.11|0.089
74100035|NCT00384930|147749169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.36|||<|0.001||95.0|1.56|5.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||5.17|1.56|<0.001
74053644|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|1.1||||0.699|TWO_SIDED|95.0|-4.5|6.6|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.6|-4.5|0.699
74053645|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.4||||0.155|TWO_SIDED|95.0|-3.0|13.8|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||13.8|-3.0|0.155
74053646|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.0||||0.546|TWO_SIDED|95.0|-2.9|0.9|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||0.9|-2.9|0.546
74053647|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
74053648|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.2||||0.269|TWO_SIDED|95.0|-1.8|6.1|||Cochran-Mantel-Haenszel|||Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.1|-1.8|0.269
74053649|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.723|TWO_SIDED|95.0|-1.6|5.6|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.6|-1.6|0.723
74053650|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
74100036|NCT00384930|147749169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.75|||<|0.001||95.0|2.95|6.54||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||6.54|2.95|<0.001
74100037|NCT00384930|147749169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.83|||<|0.001||95.0|4.04|7.62||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||7.62|4.04|<0.001
74100038|NCT00384930|147749169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.15|||<|0.001||95.0|4.35|7.95||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||7.95|4.35|<0.001
74100039|NCT00384930|147749170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.58||||0.005||95.0|-2.68|-0.48||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-0.48|-2.68|0.005
74100040|NCT00384930|147749170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|||<|0.001||95.0|-3.69|-1.51||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.51|-3.69|<0.001
74100041|NCT00384930|147749170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|||<|0.001||95.0|-3.99|-1.81||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.81|-3.99|<0.001
74053651|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 8: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the cochran method.||0.0|0.0|
74053652|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.0||||0.125|TWO_SIDED|95.0|-1.3|9.4|||Cochran-Mantel-Haenszel|||Week 8:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.4|-1.3|0.125
74053653|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.0||||0.071|TWO_SIDED|95.0|-1.7|11.8|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.8|-1.7|0.071
74053654|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.317|TWO_SIDED|95.0|-1.2|5.1|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.1|-1.2|0.317
74053655|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.28|TWO_SIDED|95.0|-1.6|5.6|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.6|-1.6|0.280
74053656|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.6||||0.892|TWO_SIDED|95.0|-7.6|8.8|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||8.8|-7.6|0.892
74100042|NCT00384930|147749170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.94|||<|0.001||95.0|-4.04|-1.84||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.84|-4.04|<0.001
74053657|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.5||||0.903|TWO_SIDED|95.0|-8.3|7.2|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.2|-8.3|0.903
74053658|NCT00883896|147658538|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.7||||0.625|TWO_SIDED|95.0|-7.2|3.8|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||3.8|-7.2|0.625
74053659|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.900
74053660|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.522
74053661|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.147|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.147
74053662|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.534|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.534
74053663|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.206|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.206
74053664|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.070
74053665|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.936|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.936
74053666|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.625
74053667|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.586|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.586
74053668|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.685
74053669|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.340
74100043|NCT00863772|147749173|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.37||0.434|TWO_SIDED|95.0|-0.44|1.01|||ANCOVA|||Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||1.01|-0.44|0.434
74100044|NCT00863772|147749173|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.37||0.883|TWO_SIDED|95.0|-0.68|0.79|||ANCOVA|||ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.79|-0.68|0.883
74100045|NCT00863772|147749174|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.37||0.72|TWO_SIDED|95.0|-0.59|0.86|||ANCOVA|||Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.86|-0.59|0.720
74053670|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.212
74053671|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.455|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.455
74053672|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.145|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.145
74053673|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.660
74053674|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.050
74053675|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.428|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.428
74053676|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.160
74053677|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.757|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.757
74053678|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.408|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.408
74053679|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.983|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.983
74100046|NCT00863772|147749174|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.37||0.985|TWO_SIDED|95.0|-0.73|0.74|||ANCOVA|||ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.74|-0.73|0.985
74100047|NCT02728843|147749214|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
74100048|NCT02728843|147749215|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
73881602|NCT03192176|147297634|SUPERIORITY||LSMean difference|3.1|STANDARD_ERROR_OF_MEAN|5.64||0.58|TWO_SIDED|95.0|-7.99|14.25||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||14.25|-7.99|0.5800
73881603|NCT03192176|147297634|SUPERIORITY||LSMean difference|2.2|STANDARD_ERROR_OF_MEAN|5.74||0.7024|TWO_SIDED|95.0|-9.11|13.5||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||13.50|-9.11|0.7024
73881604|NCT03192176|147297634|SUPERIORITY||LSMean difference|11.4|STANDARD_ERROR_OF_MEAN|5.99||0.0572|TWO_SIDED|95.0|-0.35|23.23||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||23.23|-0.35|0.0572
74053680|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.374
74053681|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.992
74053682|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.422
74053683|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.743|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.743
74053684|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.188|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.188
74053685|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.385|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.385
74053686|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.148
74053687|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.304|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.304
74053688|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.552
74053689|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.494|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.494
74053690|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.421|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.421
74053691|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.418|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.418
73881605|NCT03192176|147297634|SUPERIORITY||LSMean difference|1.6|STANDARD_ERROR_OF_MEAN|5.93||0.783|TWO_SIDED|95.0|-10.04|13.31||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||13.31|-10.04|0.7830
73881606|NCT03192176|147297634|SUPERIORITY||0.1|15.4|STANDARD_ERROR_OF_MEAN|5.71||0.0074|TWO_SIDED|95.0|4.19|26.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||26.67|4.19|0.0074
74053692|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.235|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.235
74053693|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.268|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.268
74053694|NCT00883896|147658550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.957|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.957
74053695|NCT01856920|147658570|EQUIVALENCE|Alpha= 0.05||||||0.376|||||||Rank-Sum|||||||0.3760
74053696|NCT01716585|147658582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects administered telaprevir plus peginterferon (pegIFN)/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 70% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 80% to achieve superiority.|Percentage of Participants with SVR12|96.4|||||TWO_SIDED|95.0|94.7|98.1|||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|With a sample size of 450 subjects and assuming that 92% of the subjects in Arm A will achieve SVR12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 70% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 80% (based on the normal approximation of a single binomial proportion). 95% CI calculated using the normal approximation to the binomial distribution.||98.1|94.7|
74053697|NCT01716585|147658583|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|Fisher Exact|||||||< 0.001
74053698|NCT01716585|147658584|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 75% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|95.7|||||TWO_SIDED|95.0|93.4|97.9||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|||95% CI calculated using the normal approximation to the binomial distribution.|||97.9|93.4|
74053699|NCT01716585|147658585|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 84% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|98.0|||||TWO_SIDED|95.0|95.8|100.0|||||95% CI calculated using the normal approximation to the binomial distribution.|||100.0|95.8|
74053700|NCT04646668|147658588|SUPERIORITY|Due to the pilot nature of the current study, formal power calculations were not conducted.||||||0.002|||||||ANOVA|||The null hypothesis is that there is no difference in nicotine delivery between cigarettes, e-cigarettes, and heat not burn after the standardized 10-puff bout. ANOVAs were conducted to detect differences between products for nicotine concentration at five minutes (immediately following 10-puff bout). The test was performed with a significance level of 0.05 (two-sided).||||0.002
74053701|NCT00174460|147658595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.991|STANDARD_ERROR_OF_MEAN|0.1067|<|0.001|TWO_SIDED|95.0|0.773|1.21|||ANCOVA|Results from analysis of covariance method (ANCOVA) adjusted for baseline height SDS and target height SDS; Last observation carried forward (LOCF).||Treatment difference||1.210|0.773|<0.001
74053702|NCT00174460|147658596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.415|STANDARD_ERROR_OF_MEAN|0.395|<|0.001|TWO_SIDED|95.0|3.605|5.225|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||5.225|3.605|<0.001
74053703|NCT00174460|147658596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.884|STANDARD_ERROR_OF_MEAN|0.5327||0.108|TWO_SIDED|95.0|-1.977|0.208|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||0.208|-1.977|0.108
74053704|NCT00174460|147658597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.074|STANDARD_ERROR_OF_MEAN|0.7089||0.141|TWO_SIDED|95.0|-2.524|0.376|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference||0.376|-2.524|0.141
74053705|NCT00174460|147658598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|STANDARD_ERROR_OF_MEAN|0.3661|<|0.001|TWO_SIDED|95.0|3.789|5.291|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||5.291|3.789|<0.001
74053706|NCT00174460|147658598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.064|STANDARD_ERROR_OF_MEAN|0.9822|<|0.001|TWO_SIDED|95.0|2.049|6.08|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||6.080|2.049|<0.001
74053707|NCT00174460|147658599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.719|STANDARD_ERROR_OF_MEAN|0.1606|<|0.001|TWO_SIDED|95.0|0.39|1.047|||ANCOVA|Results from ANCOVA adjusted for baseline height SDS and target height SDS; LOCF.||Treatment difference Month 24||1.047|0.390|<0.001
74053708|NCT00174460|147658600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.497|<|0.001|TWO_SIDED|95.0|-3.73|-1.68|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 12||-1.68|-3.73|<0.001
74053709|NCT00174460|147658600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.758||0.537|TWO_SIDED|95.0|-2.04|1.09|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 24||1.09|-2.04|0.537
74053710|NCT00174460|147658601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.405||0.364|TWO_SIDED|95.0|-1.21|0.46|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||0.46|-1.21|0.364
74053711|NCT00174460|147658601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.345||0.506|TWO_SIDED|95.0|-0.94|0.48|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||0.48|-0.94|0.506
74053712|NCT00174460|147658602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|1.188||0.959|TWO_SIDED|95.0|-2.42|2.54|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||2.54|-2.42|0.959
74053713|NCT00174460|147658602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|1.065||0.919|TWO_SIDED|95.0|-2.11|2.32|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||2.32|-2.11|0.919
74053714|NCT00174460|147658603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.892|STANDARD_ERROR_OF_MEAN|0.8161||0.336|TWO_SIDED|95.0|-3.158|1.374|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 12||1.374|-3.158|0.336
74053715|NCT00174460|147658603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.717|STANDARD_ERROR_OF_MEAN|0.6027||0.3|TWO_SIDED|95.0|-0.956|2.391|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 24||2.391|-0.956|0.300
74100049|NCT02728843|147749216|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
73888165|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|181.3||||0.0033|TWO_SIDED|95.0|61.5|301.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||301.0|61.5|0.0033
74100050|NCT02728843|147749217|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
74019495|NCT02522767|147591327|SUPERIORITY||Treatment difference|-0.24|||<|0.05|TWO_SIDED|95.0|-0.41|-0.08|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||-0.08|-0.41|<0.05
74053716|NCT00174460|147658604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.615|STANDARD_ERROR_OF_MEAN|0.6591|<|0.001|TWO_SIDED|95.0|4.266|6.963|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference||6.963|4.266|<0.001
74053717|NCT00174460|147658605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.482|STANDARD_ERROR_OF_MEAN|0.9666||0.653|TWO_SIDED|95.0|-3.558|2.595|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||2.595|-3.558|0.653
74053718|NCT00174460|147658605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.205|STANDARD_ERROR_OF_MEAN|0.8991||0.251|TWO_SIDED|95.0|-3.701|1.292|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||1.292|-3.701|0.251
74053719|NCT00174460|147658606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|1.1499||0.914|TWO_SIDED|95.0|-3.524|3.795|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||3.795|-3.524|0.914
74053720|NCT00174460|147658606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.4432||0.547|TWO_SIDED|95.0|-0.939|1.522|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||1.522|-0.939|0.547
74053721|NCT00174460|147658607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|0.4542||0.007|TWO_SIDED|95.0|1.049|3.572|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||3.572|1.049|0.007
74053722|NCT00174460|147658607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.626|STANDARD_ERROR_OF_MEAN|0.6536||0.068|TWO_SIDED|95.0|-0.189|3.44|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||3.440|-0.189|0.068
74053723|NCT00174460|147658610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.5061||0.331|TWO_SIDED|95.0|-0.846|1.965|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 12||1.965|-0.846|0.331
74053724|NCT00174460|147658610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.4703||0.82|TWO_SIDED|95.0|-1.192|1.42|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 24||1.420|-1.192|0.820
74053725|NCT00174460|147658611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.42||0.844|TWO_SIDED|95.0|-0.88|1.05|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 12||1.05|-0.88|0.844
74053726|NCT00174460|147658611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.329||0.519|TWO_SIDED|95.0|-0.52|0.96|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 24||0.96|-0.52|0.519
74053727|NCT00174460|147658614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.998|STANDARD_ERROR_OF_MEAN|0.1095|<|0.001|TWO_SIDED|95.0|0.778|1.219|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\*treatment and target height SDS.||Treatment difference Month 12||1.219|0.778|<0.001
74053728|NCT00174460|147658614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.688|STANDARD_ERROR_OF_MEAN|0.1519|<|0.001|TWO_SIDED|95.0|0.382|0.994|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\*treatment and target height SDS.||Treatment difference Month 24||0.994|0.382|<0.001
74053729|NCT00174460|147658616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.585|STANDARD_ERROR_OF_MEAN|0.3859|<|0.001|TWO_SIDED|95.0|3.806|5.363|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\*treatment and target height SDS.||Treatment difference Month 12||5.363|3.806|<0.001
74100051|NCT02728843|147749218|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
74053730|NCT00174460|147658616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.563|STANDARD_ERROR_OF_MEAN|0.708|<|0.001|TWO_SIDED|95.0|2.134|4.992|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\*treatment and target height SDS.||Treatment difference Month 24||4.992|2.134|<0.001
74053731|NCT02467504|147658618|OTHER|||||||0.53|||||||Chi-squared|||||||0.530
74053732|NCT02467504|147658619|OTHER|||||||0.315|||||||Chi-squared|||||||0.315
74053733|NCT02467504|147658620|OTHER|||||||0.018|||||||Mixed Models Analysis|||||||0.018
74053734|NCT02467504|147658621|OTHER|||||||0.015|||||||Mixed Models Analysis|||||||0.015
74053735|NCT02467504|147658622|OTHER|Chi||||||0.474|||||||Chi-squared|||||||0.474
74019496|NCT02522767|147591328|SUPERIORITY||Treatment difference|-2.39|||>|0.05|TWO_SIDED|95.0|-5.46|0.67|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||0.67|-5.46|>0.05
74053736|NCT02467504|147658623|OTHER|description of Treg cells in CD4+ T cells||||||0.665|||||||Mixed Models Analysis|||||||0.665
74053737|NCT02467504|147658624|OTHER|||||||0.616|||||||Chi-squared|||||||0.616
74053738|NCT02467504|147658625|OTHER|||||||0.616|||||||Chi-squared|||||||0.616
74053739|NCT02467504|147658626|OTHER|||||||0.2|||||||Chi-squared|||||||0.200
74053740|NCT02467504|147658627|OTHER|||||||0.373|||||||Chi-squared|||||||0.373
74053741|NCT02467504|147658628|OTHER|||||||0.565|||||||Chi-squared|||||||0.565
74053742|NCT02467504|147658629|OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||||||0.221
74053743|NCT02467504|147658630|OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
74053744|NCT02467504|147658631|OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.740
74100052|NCT02728843|147749219|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
74100053|NCT02728843|147749220|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
74100054|NCT00351533|147749230|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.37
73881607|NCT03192176|147297634|SUPERIORITY||LSMean difference|11.0|STANDARD_ERROR_OF_MEAN|5.73||0.0551|TWO_SIDED|95.0|-0.24|22.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||22.32|-0.24|0.0551
73881608|NCT03192176|147297634|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|5.51||0.2959|TWO_SIDED|95.0|-16.63|5.08||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||5.08|-16.63|0.2959
73881609|NCT03192176|147297634|SUPERIORITY||LSMean difference|5.8|STANDARD_ERROR_OF_MEAN|5.55||0.2976|TWO_SIDED|95.0|-5.14|16.74||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||16.74|-5.14|0.2976
73881610|NCT03192176|147297634|SUPERIORITY||LSMean difference|2.0|STANDARD_ERROR_OF_MEAN|5.62||0.7236|TWO_SIDED|95.0|-9.07|13.05||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||13.05|-9.07|0.7236
73881611|NCT03192176|147297634|SUPERIORITY||LSMean difference|10.1|STANDARD_ERROR_OF_MEAN|5.88||0.0884|TWO_SIDED|95.0|-1.52|21.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||21.63|-1.52|0.0884
74053745|NCT02467504|147658632|OTHER|||||||0.881|||||||Mixed Models Analysis|||||||0.881
74053746|NCT02467504|147658633|OTHER|||||||0.422|||||||Mixed Models Analysis|||||||0.422
73881612|NCT03192176|147297634|SUPERIORITY||LSMean difference|-5.0|STANDARD_ERROR_OF_MEAN|5.77||0.3887|TWO_SIDED|95.0|-16.35|6.38||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||6.38|-16.35|0.3887
73881613|NCT03192176|147297634|SUPERIORITY||LSMean difference|6.2|STANDARD_ERROR_OF_MEAN|5.59||0.2671|TWO_SIDED|95.0|-4.8|17.24||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||17.24|-4.80|0.2671
73881614|NCT03192176|147297634|SUPERIORITY||LSMean difference|2.9|STANDARD_ERROR_OF_MEAN|5.63||0.6076|TWO_SIDED|95.0|-8.2|13.99||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||13.99|-8.20|0.6076
74019497|NCT02522767|147591329|SUPERIORITY||Treatment difference|-289.69|||<|0.05|TWO_SIDED|95.0|-514.96|-64.42|||ANCOVA||An ANCOVA model was used to calculate estimates.|Changes from baseline were compared between treatment groups, at a two-sided 0.05 significance level.||-64.42|-514.96|<0.05
74019498|NCT02522767|147591330|SUPERIORITY||Treatment difference|12.8|||<|0.05|TWO_SIDED|95.0|5.1|20.5|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimates.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||20.50|5.10|<0.05
74019499|NCT04233229|147591383|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|27.4|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|15.0|39.8||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||39.8|15.0|<.001
74019500|NCT04233229|147591384|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) during diurnal period at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|23.0|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|10.6|35.5||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||35.5|10.6|<.001
74019501|NCT04233229|147591385|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) during nocturnal period at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|40.8|STANDARD_ERROR_OF_MEAN|7.2|<|0.001|TWO_SIDED|95.0|25.8|55.8||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||55.8|25.8|<.001
74019502|NCT04233229|147591386|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Above Range (TAR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|-27.7|STANDARD_ERROR_OF_MEAN|6.1|<|0.001|TWO_SIDED|95.0|-40.5|-15.0||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-15.0|-40.5|<.001
74019503|NCT04233229|147591387|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Above Range (TAR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|-20.1|STANDARD_ERROR_OF_MEAN|5.9||0.003|TWO_SIDED|95.0|-32.4|-7.9||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-7.9|-32.4|0.003
74053747|NCT02467504|147658634|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
74053748|NCT02467504|147658635|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
74053749|NCT02467504|147658636|OTHER|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.156
74053750|NCT04047472|147658649|NON_INFERIORITY|Non-inferiority of brolucizumab to aflibercept with respect to change from baseline in BCVA, considering a margin of 4 letters.|LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.16||0.006|TWO_SIDED|90.0|-3.0|0.9|||ANOVA|||||0.9|-3.0|0.006
74053751|NCT04047472|147658650|NON_INFERIORITY|Non-inferiority of brolucizumab to aflibercept with respect to change from baseline in BCVA, considering a margin of 4 letters.|LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.11||0.009|TWO_SIDED|90.0|-3.2|0.5|||ANOVA|||||0.5|-3.2|0.009
74053752|NCT01632345|147658709|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|6.7|||||TWO_SIDED|95.0|-9.0|22.4|||||A negative value would be considered as favoring doravirine over efavirenz.|||22.4|-9.0|
74053753|NCT01632345|147658709|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|9.7|||||TWO_SIDED|95.0|-4.6|24.9|||||A negative value would be considered as favoring doravirine over efavirenz.|||24.9|-4.6|
74053754|NCT01632345|147658709|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-11.9|||||TWO_SIDED|95.0|-27.9|6.3|||||A negative value would be considered as favoring doravirine over efavirenz.|||6.3|-27.9|
74053755|NCT01632345|147658709|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|2.0|||||TWO_SIDED|95.0|-14.5|18.4|||||A negative value would be considered as favoring doravirine over efavirenz.|||18.4|-14.5|
74053756|NCT01632345|147658710|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-2.3|||||TWO_SIDED|95.0|-13.7|8.8|||||A negative value would be considered as favoring doravirine over efavirenz.|||8.8|-13.7|
74053757|NCT01632345|147658710|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|2.2|||||TWO_SIDED|95.0|-9.9|14.7|||||A negative value would be considered as favoring doravirine over efavirenz.|||14.7|-9.9|
74053758|NCT01632345|147658710|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-2.4|||||TWO_SIDED|95.0|-13.8|8.2|||||A negative value would be considered as favoring doravirine over efavirenz.|||8.2|-13.8|
74053759|NCT01632345|147658710|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-4.8|||||TWO_SIDED|95.0|-15.9|4.1|||||A negative value would be considered as favoring doravirine over efavirenz.|||4.1|-15.9|
74053760|NCT01632345|147658711|SUPERIORITY_OR_OTHER||Difference|-10.2|||||TWO_SIDED|95.0|-20.9|0.5|||||A negative value would be considered as favoring doravirine over efavirenz.|||0.5|-20.9|
74053761|NCT01632345|147658712|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-20.4||||0.002|TWO_SIDED|95.0|-32.4|-7.8||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.|||-7.8|-32.4|0.002
74053762|NCT01632345|147658713|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-20.4||||0.002|TWO_SIDED|95.0|-32.6|-7.5||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.|||-7.5|-32.6|0.002
74053763|NCT01632345|147658714|SUPERIORITY_OR_OTHER||Difference in % response|15.7|||||TWO_SIDED|95.0|-4.1|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.|||34.4|-4.1|
74053764|NCT01632345|147658714|SUPERIORITY_OR_OTHER||Difference in % response|10.0|||||TWO_SIDED|95.0|-9.6|29.1|||||A positive value would be considered as favoring doravirine over efavirenz.|||29.1|-9.6|
74053765|NCT01632345|147658714|SUPERIORITY_OR_OTHER||Difference in % response|6.6|||||TWO_SIDED|95.0|-13.2|26.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||26.0|-13.2|
74053766|NCT01632345|147658714|SUPERIORITY_OR_OTHER||Difference in % response|15.9|||||TWO_SIDED|95.0|-3.4|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.|||34.4|-3.4|
74053767|NCT01632345|147658715|SUPERIORITY_OR_OTHER||Difference in % response|-0.5|||||TWO_SIDED|95.0|-13.2|11.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||11.2|-13.2|
74053768|NCT01632345|147658716|SUPERIORITY_OR_OTHER||Difference in % response|-1.9|||||TWO_SIDED|95.0|-12.9|9.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||9.2|-12.9|
74053769|NCT01632345|147658717|SUPERIORITY_OR_OTHER||Difference in % response|-0.8|||||TWO_SIDED|95.0|-12.4|10.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||10.7|-12.4|
74053770|NCT01632345|147658718|SUPERIORITY_OR_OTHER||Difference in % response|4.5|||||TWO_SIDED|95.0|-12.5|21.5|||||A positive value would be considered as favoring doravirine over efavirenz.|||21.5|-12.5|
74053771|NCT01632345|147658718|SUPERIORITY_OR_OTHER||Difference in % response|2.8|||||TWO_SIDED|95.0|-13.9|19.8|||||A positive value would be considered as favoring doravirine over efavirenz.|||19.8|-13.9|
74053772|NCT01632345|147658718|SUPERIORITY_OR_OTHER||Difference in % response|12.2|||||TWO_SIDED|95.0|-2.5|28.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||28.0|-2.5|
74053773|NCT01632345|147658718|SUPERIORITY_OR_OTHER||Difference in % response|9.5|||||TWO_SIDED|95.0|-6.2|25.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||25.7|-6.2|
74053774|NCT01632345|147658719|SUPERIORITY_OR_OTHER||Difference in % response|2.7||||||95.0|-6.1|11.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||11.7|-6.1|
74053775|NCT01632345|147658720|SUPERIORITY_OR_OTHER||Difference in % response|0.1|||||TWO_SIDED|95.0|-9.7|9.9|||||A positive value would be considered as favoring doravirine over efavirenz.|||9.9|-9.7|
74053776|NCT01632345|147658721|SUPERIORITY_OR_OTHER||Difference in % response|3.9|||||TWO_SIDED|95.0|-7.3|15.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||15.0|-7.3|
74053777|NCT01632345|147658722|SUPERIORITY_OR_OTHER||Difference in CD4 change|33.0|||||TWO_SIDED|95.0|-28.1|94.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||94.0|-28.1|
74053778|NCT01632345|147658722|SUPERIORITY_OR_OTHER||Difference in CD4 change|-8.3|||||TWO_SIDED|95.0|-68.5|51.9|||||A positive value would be considered as favoring doravirine over efavirenz.|||51.9|-68.5|
74053779|NCT01632345|147658722|SUPERIORITY_OR_OTHER||Difference in CD4 change|12.5|||||TWO_SIDED|95.0|-44.6|69.5|||||A positive value would be considered as favoring doravirine over efavirenz.|||69.5|-44.6|
74053780|NCT01632345|147658722|SUPERIORITY_OR_OTHER||Difference in CD4 change|19.6|||||TWO_SIDED|95.0|-45.1|84.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||84.2|-45.1|
74053781|NCT01632345|147658723|SUPERIORITY_OR_OTHER||Difference in CD4 change|6.3|||||TWO_SIDED|95.0|-38.2|50.8|||||A positive value would be considered as favoring doravirine over efavirenz.|||50.8|-38.2|
74100055|NCT00351533|147749231|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
74053782|NCT01632345|147658724|SUPERIORITY_OR_OTHER||Difference in CD4 change|-2.6|||||TWO_SIDED|95.0|-46.5|41.3|||||A positive value would be considered as favoring doravirine over efavirenz.|||41.3|-46.5|
74053783|NCT01632345|147658725|SUPERIORITY_OR_OTHER||Difference in CD4 change|-4.4|||||TWO_SIDED|95.0|-64.0|55.1|||||A positive value would be considered as favoring doravirine over efavirenz.|||55.1|-64.0|
74053784|NCT01632345|147658726|SUPERIORITY_OR_OTHER||Difference|-2.8|||||TWO_SIDED|95.0|-11.7|6.0|||||A negative value would be considered as favoring doravirine over efavirenz.|||6.0|-11.7|
74053785|NCT01632345|147658727|SUPERIORITY_OR_OTHER||Difference|-6.5|||||TWO_SIDED|95.0|-14.1|0.3|||||A negative value would be considered as favoring doravirine over efavirenz.|||0.3|-14.1|
74053786|NCT00545740|147658743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0|||||Cochran-Mantel-Haenszel|||||||0.063
74053787|NCT00545740|147658743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.736||95.0|||||Cochran-Mantel-Haenszel|||||||0.736
74053788|NCT00545740|147658743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0|||||Cochran-Mantel-Haenszel|||||||0.780
74053789|NCT00545740|147658745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0|||||Cochran-Mantel-Haenszel|||||||0.047
74053790|NCT00545740|147658745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0|||||Cochran-Mantel-Haenszel|||||||0.741
74053791|NCT00545740|147658745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0|||||Cochran-Mantel-Haenszel|||||||0.780
74053792|NCT04269629|147658752|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACEI) and the group without such treatment. The primary outcome was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.25||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||It was assumed that 24% of the patients would be on β-blockers and/or ACE inhibitors (ACEI). A χ2 test with a two-sided 5% significance level has an 80% power to detect the difference between the group without antihypertensive medication with 6% SR during VIT and the group on β-blockers and/or ACEI with 12.3% SR during VIT (OR = 2.2) when the sample sizes are 631 and 200, respectively. A drop-out rate of 37% was assumed which resulted in a required number of 1,319 patients.||||0.25
74053793|NCT04269629|147658753|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.29||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.29
74053794|NCT04269629|147658754|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitor) and the group without such treatment. The secondary outcomes were analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.04||||||The level of significance was set at 0.05. Correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions (p=0.04).|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions.||||0.04
74053795|NCT04269629|147658755|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.|||||<|0.001||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||<0.001
74053796|NCT04269629|147658756|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.99||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for sIgE levels - bee venom.||||0.99
74053797|NCT04269629|147658756|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.15||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for sIgE levels - vespid venom.||||0.15
74053798|NCT04269629|147658757|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.16||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.16
74100056|NCT00351533|147749232|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.16
74100057|NCT00351533|147749233|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
74100058|NCT00351533|147749234|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.34
74053799|NCT04269629|147658758|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.5||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.50
74053800|NCT04269629|147658759|OTHER|||||||0.72||||||The level of significance was set at 0.05.|Fisher Exact|||||||0.72
74053801|NCT04269629|147658760|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitor) and the group without such treatment. The secondary outcomes were analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.11||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more frequent SR under VIT.||||0.11
74053802|NCT03123549|147658764|SUPERIORITY|||||||0.017|||||||t-test, 1 sided|||||||0.017
74053803|NCT03370133|147658780|SUPERIORITY||Odds Ratio (OR)|99.869|||<|0.001|TWO_SIDED|95.0|34.02|293.175||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||293.175|34.020|<0.001
74053804|NCT03370133|147658780|SUPERIORITY||Odds Ratio (OR)|6.056|||<|0.001|TWO_SIDED|95.0|3.874|9.466||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||9.466|3.874|<0.001
74053805|NCT03370133|147658781|SUPERIORITY||Odds Ratio (OR)|118.762|||<|0.001|TWO_SIDED|95.0|36.701|384.307||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||384.307|36.701|<0.001
74053806|NCT03370133|147658781|SUPERIORITY||Odds Ratio (OR)|4.809|||<|0.001|TWO_SIDED|95.0|3.096|7.47||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||7.470|3.096|<0.001
74053807|NCT03370133|147658782|SUPERIORITY||Odds Ratio (OR)|25.59|||<|0.001|TWO_SIDED|95.0|9.063|72.253||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||72.253|9.063|<0.001
74053808|NCT03370133|147658783|SUPERIORITY||Odds Ratio (OR)|25.471|||<|0.001|TWO_SIDED|95.0|9.02|71.925||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||71.925|9.020|<0.001
74053809|NCT03370133|147658784|SUPERIORITY||Odds Ratio (OR)|123.02|||<|0.001|TWO_SIDED|95.0|29.394|514.862||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||514.862|29.394|<0.001
74053810|NCT03370133|147658784|SUPERIORITY||Odds Ratio (OR)|18.202|||<|0.001|TWO_SIDED|95.0|10.998|30.123||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||30.123|10.998|<0.001
74053811|NCT03370133|147658785|SUPERIORITY||Odds Ratio (OR)|16.258|||<|0.001|TWO_SIDED|95.0|7.356|35.931||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||35.931|7.356|<0.001
74053812|NCT03370133|147658786|SUPERIORITY||Odds Ratio (OR)|22.279|||<|0.001|TWO_SIDED|95.0|9.795|50.674||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||50.674|9.795|<0.001
74053813|NCT03370133|147658787|SUPERIORITY||Odds Ratio (OR)|23.049|||<|0.001|TWO_SIDED|95.0|10.201|52.077||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||52.077|10.201|<0.001
74053814|NCT03370133|147658788|SUPERIORITY||Odds Ratio (OR)|37.696|||<|0.001|TWO_SIDED|95.0|16.92|83.987||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||83.987|16.920|<0.001
74100059|NCT00351533|147749235|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||t-test, 2 sided|||||||0.26
74100060|NCT00351533|147749236|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
73881615|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.91||0.2159|TWO_SIDED|95.0|-2.93|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.67|-2.93|0.2159
74053815|NCT03370133|147658789|SUPERIORITY||Odds Ratio (OR)|8.047|||<|0.001|TWO_SIDED|95.0|5.107|12.679||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||12.679|5.107|<0.001
74053816|NCT03370133|147658790|SUPERIORITY||Odds Ratio (OR)|3.795|||<|0.001|TWO_SIDED|95.0|2.442|5.899||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||5.899|2.442|<0.001
74053817|NCT03370133|147658791|SUPERIORITY||Odds Ratio (OR)|4.379|||<|0.001|TWO_SIDED|95.0|2.85|6.73||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||6.730|2.850|<0.001
74053818|NCT03370133|147658792|SUPERIORITY||Odds Ratio (OR)|2.412|||<|0.001|TWO_SIDED|95.0|1.573|3.699||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.699|1.573|<0.001
74053819|NCT03742271|147658826|SUPERIORITY|Superiority was concluded in the lower limit of the 95% confidence interval was above 0.50.|Proportion|0.974|||||TWO_SIDED|95.0|0.925|0.995|||Binomial Exact Test|||This study was powered to test the hypothesis that at least 50% will have an acceptable lens fitting.||0.995|0.925|
74053820|NCT01899729|147658831|OTHER|Used mixed effects model||||||0.06|||||||Mixed Models Analysis|||||||0.06
74053821|NCT03125902|147658832|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2032|TWO_SIDED|95.0|0.6|1.12|||Log Rank|||Stratified Analysis||1.12|0.60|0.2032
74053822|NCT03125902|147658832|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.2601|TWO_SIDED|95.0|0.62|1.14|||Log Rank|||Unstratified Analysis||1.14|0.62|0.2601
74053823|NCT03125902|147658833|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.86||||0.1343|TWO_SIDED|95.0|0.7|1.05|||Log Rank|||||1.05|0.70|0.1343
74053824|NCT03125902|147658833|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1285|TWO_SIDED|95.0|0.7|1.05|||Log Rank|||Unstratified Analysis||1.05|0.70|0.1285
74053825|NCT03125902|147658834|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5798|TWO_SIDED|95.0|0.76|1.64|||Log Rank|||Stratified Analysis||1.64|0.76|0.5798
74053826|NCT03125902|147658834|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4035|TWO_SIDED|95.0|0.8|1.72|||Log Rank|||Unstratified Analysis||1.72|0.80|0.4035
74053827|NCT03125902|147658835|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.3425|TWO_SIDED|95.0|0.88|1.43|||Log Rank|||Stratified analysis||1.43|0.88|0.3425
74053828|NCT03125902|147658835|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2166|TWO_SIDED|95.0|0.92|1.48|||Log Rank|||Unstratified Analysis||1.48|0.92|0.2166
74053829|NCT03125902|147658837|OTHER|Stratified analysis|Hazard Ratio (HR)|0.94||||0.6465|TWO_SIDED|95.0|0.71|1.24|||Log Rank|||||1.24|0.71|0.6465
74053830|NCT03125902|147658839|OTHER||Odds Ratio (OR)|1.44||||0.1526|TWO_SIDED|95.0|0.87|2.37|||Cochran-Mantel-Haenszel|||||2.37|0.87|0.1526
74100061|NCT00351533|147749237|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.89
74053831|NCT03125902|147658840|OTHER||Odds Ratio (OR)|1.4||||0.1834|TWO_SIDED|95.0|0.85|2.31|||Cochran-Mantel-Haenszel|||||2.31|0.85|0.1834
74053832|NCT03125902|147658841|OTHER||Odds Ratio (OR)|1.42||||0.0513|TWO_SIDED|95.0|1.0|2.02|||Cochran-Mantel-Haenszel|||||2.02|1.00|0.0513
74053833|NCT03125902|147658842|OTHER||Odds Ratio (OR)|1.3||||0.1226|TWO_SIDED|95.0|0.93|1.81|||Cochran-Mantel-Haenszel|||||1.81|0.93|0.1226
74053834|NCT03125902|147658843|OTHER|Unstratified Analysis|Hazard Ratio (HR)|0.74||||0.0641|TWO_SIDED|95.0|0.54|1.02|||Log Rank|||||1.02|0.54|0.0641
74053835|NCT03125902|147658853|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.01227|TWO_SIDED|95.0|0.42|0.9|||Log Rank|||Unstratified Analysis||0.90|0.42|0.01227
74053836|NCT01078389|147658854|SUPERIORITY_OR_OTHER|||||||0.472|||||||Ranked Analysis of Covariance (ANCOVA)|Baseline modified Sharp/van der Heijde Erosion Score as a covariate.||Change from Baseline at Month 24||||0.472
74053837|NCT01078389|147658855|SUPERIORITY_OR_OTHER|||||||0.548|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score from full hands and feet as a covariate.||Change from Baseline at Month 24||||0.548
74053838|NCT01078389|147658856|SUPERIORITY_OR_OTHER|||||||0.389|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Erosion Score from full hands and feet as a covariate.||Change from Baseline at Month 24||||0.389
74053839|NCT01078389|147658857|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|Baseline RAMRIS Synovitis Score as a covariate.||Synovitis: Change from Baseline at Month 24||||<0.001
74053840|NCT01078389|147658857|SUPERIORITY_OR_OTHER|||||||0.634|||||||Ranked ANCOVA|Baseline RAMRIS Erosion(Distal+Proximal) Score as a covariate.||Erosion(Distal+Proximal): Change from Baseline at Month 24||||0.634
74053841|NCT01078389|147658857|SUPERIORITY_OR_OTHER|||||||0.307|||||||Ranked ANCOVA|Baseline RAMRIS Edema(Distal+Proximal) Score as a covariate.||Edema(Distal+Proximal): Change from Baseline at Month 24||||0.307
74053842|NCT01078389|147658858|SUPERIORITY_OR_OTHER|||||||0.122|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score as a covariate.||Change from Baseline at Month 24||||0.122
74053843|NCT03691831|147658868|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0001|TWO_SIDED|95.0|2.14|10.76||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mixed Models Analysis|||A summary of the wart clearance at Visit 10.||10.76|2.14|0.0001
74053844|NCT03691831|147658869|SUPERIORITY||Mean Difference (Final Values)|2.71||||0.0001|TWO_SIDED|95.0|1.61|4.56|||Mixed Models Analysis|||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.||4.56|1.61|0.0001
74100062|NCT00351533|147749238|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
74100063|NCT00351533|147749239|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
74053845|NCT03691831|147658870|SUPERIORITY||Odds Ratio (OR)|15.44|||<|0.0001|TWO_SIDED|95.0|9.0|21.8|||Wilcoxon (Mann-Whitney)|||||21.8|9.0|<0.0001
74053846|NCT03691831|147658871|SUPERIORITY||Odds Ratio (OR)|5.2||||0.0006|TWO_SIDED|95.0|1.76|15.53|||Wilcoxon (Mann-Whitney)|||||15.53|1.76|0.0006
74053847|NCT03691831|147658872|SUPERIORITY||Hazard Ratio (HR)|3.33|||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
74053848|NCT02028182|147658873|OTHER||Kappa statistic-Concordance 0.4 mg/cm2|75.0|||||TWO_SIDED|95.0|60.4|94.0||||||||94.0|60.4|
74053849|NCT02028182|147658873|OTHER||Kappa statistic: Concordance 0.20 mg/cm2|65.0|||||TWO_SIDED|95.0|55.6|90.4||||||||90.4|55.6|
74053850|NCT02028182|147658873|OTHER||Kappa statistic: Concordance0.10 mg/cm2|60.0|||||TWO_SIDED|95.0|53.3|88.4||||||||88.4|53.3|
74053851|NCT01519648|147658876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.872|STANDARD_ERROR_OF_MEAN|0.237||0.007|TWO_SIDED|95.0|1.178|2.977|||Chi-squared|||||2.977|1.178|0.007
74053852|NCT04524663|147658890|SUPERIORITY||Median Difference (Net)|0.59||||0.89|TWO_SIDED|95.0|-8.14|9.32|||Regression, Linear|||||9.32|-8.14|0.89
74053853|NCT04524663|147658891|SUPERIORITY||Median Difference (Net)|18.9||||0.02|TWO_SIDED|95.0|2.98|34.83|||Regression, Linear|||||34.83|2.98|0.02
74053854|NCT04524663|147658892|SUPERIORITY||Hazard Ratio (HR)|1.69||||0.24|TWO_SIDED|95.0|0.7|4.1|||Cox proportional hazards model|||||4.10|0.70|0.24
74053855|NCT04524663|147658893|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
74053856|NCT04524663|147658894|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.24|TWO_SIDED|95.0|0.32|1.33|||Cox proportional hazards model|||||1.33|0.32|0.24
74053857|NCT00337935|147658897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0062|TWO_SIDED|95.0|0.2|0.9||a priori theshold for statistical significance was p=0.05|ANCOVA|Baseline Hemoglobin was used as a covariate.||||0.9|0.2|.0062
74053858|NCT00337935|147658898|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance p=0.05|Chi-squared|||||||<0.001
74053859|NCT00337935|147658899|SUPERIORITY_OR_OTHER||||||<|0.0001||||||A priori threshold for statistical significance p=0.05|Log Rank|||||||<0.0001
74053860|NCT00711009|147658900|NON_INFERIORITY_OR_EQUIVALENCE|The exact 95% confidence interval for the difference in response rates (LPV/r + RAL minus LPV/r + FTC/TDF) was used to assess non-inferiority. The LPV/r+RAL arm was considered non-inferior to the LPV/r+FTC/TDF arm because the lower limit of the confidence interval was \>/= -20%. Because the LPV/r+RAL arm was considered non-inferior based on the 20% margin, the results were assessed on a more rigorous 12% margin (-12%), as prespecified.|Diff. in Percentage of Subj. Responding|-1.6||||0.85|TWO_SIDED|95.0|-12.0|8.8|||exact binomial method|||The null hypothesis was that the response rate for the LPV/r + RAL arm was more than 20% lower than the response rate for the LPV/r + FTC/TDF arm. The planned sample size of 100 participants per treatment group provided 90% power to conclude that the LPV/r + RAL arm was non-inferior to the control arm, based on a non-inferiority margin of -20% (with a type I error rate of 0.05).||8.8|-12.0|0.850
74053861|NCT01682876|147658990|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccine Group Differences at Day 86|19.0|||||TWO_SIDED|97.5|10.0|28.9|||MN method|||Non-inferiority of seroresponse of two vaccinations vs.one vaccination for age cohort (2 to 5 years of age) for MenA||28.9|10|
74053862|NCT01682876|147658990|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccine Group Differences at Day 86|27.0|||||TWO_SIDED|97.5|16.9|37.7|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenC||37.7|16.9|
74053863|NCT01682876|147658990|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccine Group Differences at Day 86|14.0|||||TWO_SIDED|97.5|1.4|26.7|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenW||26.7|1.4|
74053864|NCT01682876|147658990|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for Men Y|Vaccine Group differences at Day 86|27.0|||||TWO_SIDED|97.5|15.6|37.6|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenY||37.6|15.6|
74053865|NCT01682876|147658990|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccines Group Differences at Day 86|11.0|||||TWO_SIDED|97.5|1.7|21.3|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenA||21.3|1.7|
74053866|NCT01682876|147658990|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccines Group differences at Day 86|19.0|||||TWO_SIDED|97.5|9.9|29.2|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenC||29.2|9.9|
74100064|NCT00351533|147749240|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.20
74100065|NCT00351533|147749241|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
74100066|NCT00351533|147749242|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||t-test, 2 sided|||||||0.56
74100067|NCT00351533|147749243|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 2 sided|||||||0.69
74100068|NCT00351533|147749244|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
74100069|NCT00351533|147749245|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||||||0.27
74100070|NCT00351533|147749246|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Chi-squared|||||||0.65
73881616|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.92||0.0405|TWO_SIDED|95.0|-3.7|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.08|-3.70|0.0405
74019504|NCT04233229|147591388|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Below Range (TBR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.79|TWO_SIDED|95.0|-1.0|1.3||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||1.3|-1.0|0.79
74100071|NCT00351533|147749247|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Chi-squared|||||||0.49
74100072|NCT00351533|147749248|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.55
73881617|NCT03192176|147297635|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.93||0.0115|TWO_SIDED|95.0|-4.18|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.53|-4.18|0.0115
74019505|NCT04233229|147591389|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Below Range (TBR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.84|TWO_SIDED|95.0|-0.3|0.4||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||0.4|-0.3|0.84
74019506|NCT04233229|147591390|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and glucose variability (% CV Coefficient of Variation) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|3.7|STANDARD_ERROR_OF_MEAN|1.9||0.06|TWO_SIDED|95.0|-0.2|7.6||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||7.6|-0.2|0.060
74019507|NCT04233229|147591391|SUPERIORITY|Analysis of covariance (ANCOVA) model with 2 factors: HbA1c value at baseline and study group|Adjusted means difference|-1.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.9|-0.7||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-0.7|-1.9|<.001
74100073|NCT00351533|147749249|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.38
74100074|NCT00351533|147749250|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
74100075|NCT00351533|147749251|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.74
74100076|NCT00351533|147749252|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
74100077|NCT00351533|147749253|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.71
74100078|NCT00351533|147749254|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.08
74100079|NCT00351533|147749255|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
74100080|NCT00351533|147749256|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.89
74100081|NCT00351533|147749257|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.34
74100082|NCT03452137|147749291|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6804|TWO_SIDED|95.0|0.7|1.26|||Log Rank||HR was estimated by Cox regression.|Stratified Analysis: The stratification factors were response to definitive local therapy, human papillomavirus (HPV) status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.26|0.70|0.6804
74100083|NCT03452137|147749292|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.8371|TWO_SIDED|95.0|0.68|1.36|||Log Rank||HR was estimated by Cox regression.|Stratified Analysis: The stratification factors were response to definitive local therapy, HPV status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.36|0.68|0.8371
74100084|NCT03452137|147749293|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9115|TWO_SIDED|95.0|0.73|1.32|||Log Rank||HR was estimated by Cox regression|Stratified Analysis: The stratification factors were response to definitive local therapy, HPV status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.32|0.73|0.9115
74100085|NCT03452137|147749294|SUPERIORITY||Difference in Event Free Rate|-0.67||||0.8816|TWO_SIDED|95.0|-9.45|8.11|||Z test|||Difference in EFS Event-Free Rates at 1 year||8.11|-9.45|0.8816
74100086|NCT03452137|147749294|SUPERIORITY||Difference in Event Free Rate|0.46||||0.9234|TWO_SIDED|95.0|-8.86|9.78|||Z test|||Difference in EFS Event-Free Rates at 2 years||9.78|-8.86|0.9234
74100087|NCT03452137|147749294|SUPERIORITY||Difference in Event Free Rate|1.19||||0.809|TWO_SIDED|95.0|-8.49|10.88|||Z test|||Difference in EFS Event-Free Rates at 3 years||10.88|-8.49|0.8090
74100088|NCT03452137|147749294|SUPERIORITY||Difference in Event Free Rate|0.01||||0.9985|TWO_SIDED|95.0|-10.17|10.19|||Z test|||Difference in EFS Event-Free Rates at 4 years||10.19|-10.17|0.9985
74100089|NCT03452137|147749295|SUPERIORITY||Difference in Event Free Rate|5.17||||0.2393|TWO_SIDED|95.0|-3.44|13.79|||Z test|||Difference in EFS Event-Free Rates at 1 year||13.79|-3.44|0.2393
74100090|NCT03452137|147749295|SUPERIORITY||Difference in Event Free Rate|3.61||||0.4472|TWO_SIDED|95.0|-5.69|12.9|||Z test|||Difference in EFS Event-Free Rates at 2 years||12.90|-5.69|0.4472
74100091|NCT03452137|147749295|SUPERIORITY||Difference in Event Free Rate|3.14||||0.5222|TWO_SIDED|95.0|-6.49|12.77|||Z test|||Difference in EFS Event-Free Rates at 3 years||12.77|-6.49|0.5222
74100092|NCT03452137|147749295|SUPERIORITY||Difference in Event Free Rate|1.31||||0.7967|TWO_SIDED|95.0|-8.64|11.26|||Z test|||Difference in EFS Event-Free Rates at 4 years||11.26|-8.64|0.7967
74053867|NCT01682876|147658990|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccines Group Differences at Day 86|4.0|||||TWO_SIDED|97.5|-8.6|17.4|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenW||17.4|-8.6|
74053868|NCT01682876|147658990|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenY|Vaccines Group Differences at Day 86|29.0|||||TWO_SIDED|97.5|18.4|40.0|||MN method|||Non-inferiority of seroresponse for two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenY||40|18.4|
74053869|NCT01682876|147658991|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|18.0|||||TWO_SIDED|98.75|9.1|28.0|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA||28|9.1|
74100093|NCT03452137|147749296|SUPERIORITY||Difference in Event Free Rate|2.77||||0.4819|TWO_SIDED|95.0|-4.95|10.49|||Z test|||Difference in OS Event-Free Rates at 2 years||10.49|-4.95|0.4819
74053870|NCT01682876|147658991|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|28.0||||||98.75|17.1|38.7|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC||38.7|17.1|
74053871|NCT01682876|147658991|SUPERIORITY_OR_OTHER||Vaccine Group differences at Day 86|14.0|||||TWO_SIDED|98.75|1.0|27.1|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW||27.1|1|
74053872|NCT01682876|147658991|SUPERIORITY_OR_OTHER||Vaccine groups Differences at Day 86|28.0|||||TWO_SIDED|98.75|16.2|39.3|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY||39.3|16.2|
74053873|NCT01682876|147658991|SUPERIORITY_OR_OTHER||Vaccine groups differences at Day 86|11.0|||||TWO_SIDED|98.75|1.0|21.2|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA||21.2|1|
74053874|NCT01682876|147658991|SUPERIORITY_OR_OTHER||Vaccine Group differences at Day 86|18.0|||||TWO_SIDED|97.5|9.5|27.1|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC||27.1|9.5|
74053875|NCT01682876|147658991|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|5.0|||||TWO_SIDED|98.75|-8.4|18.8|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW||18.8|-8.4|
74053876|NCT01682876|147658991|SUPERIORITY_OR_OTHER||Vaccine group Differences at Day 86|29.0|||||TWO_SIDED|98.75|17.0|39.6|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY||39.6|17|
74053877|NCT01682876|147658996|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||||TWO_SIDED|95.0|1.17|4.53||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM||4.53|1.17|
74053878|NCT01682876|147658996|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.75|||||TWO_SIDED|95.0|1.18|6.36||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM||6.36|1.18|
74053879|NCT01682876|147658996|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.85|1.34||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced tenderness in the two doses versus in the one dose of MenACWY-CRM||1.34|0.85|
74053880|NCT01682876|147658996|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.54|1.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced change in eating habits in the two doses versus in the one dose of MenACWY-CRM||1.42|0.54|
74053881|NCT01682876|147658996|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.76|1.52||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced sleepiness in the two doses versus in the one dose of MenACWY-CRM||1.52|0.76|
74053882|NCT01682876|147658996|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.74|1.43||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced irritability in the two doses versus in the one dose of MenACWY-CRM||1.43|0.74|
74053883|NCT01682876|147658996|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.33|1.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM||1.74|0.33|
74053884|NCT01682876|147658997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.77|2.65||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM||2.65|0.77|
74053885|NCT01682876|147658997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.49|||||TWO_SIDED|95.0|0.81|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM||2.74|0.81|
74100094|NCT03452137|147749296|SUPERIORITY||Difference in Event Free Rate|-1.25||||0.7783|TWO_SIDED|95.0|-9.97|7.47|||Z test|||Difference in OS Event-Free Rates at 3 years||7.47|-9.97|0.7783
74053886|NCT01682876|147658997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.27|||||TWO_SIDED|95.0|1.04|1.55||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced pain in the two doses versus in the one dose of MenACWY-CRM||1.55|1.04|
74053887|NCT01682876|147658997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.81|||||TWO_SIDED|95.0|0.98|3.33||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced loss of appetite in the two doses versus in the one dose of MenACWY-CRM||3.33|0.98|
74053888|NCT01682876|147658997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.77|2.17||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced nausea in the two doses versus in the one dose of MenACWY-CRM||2.17|0.77|
74053889|NCT01682876|147658997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.65|||||TWO_SIDED|95.0|1.06|2.57||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fatigue in the two doses versus in the one dose of MenACWY-CRM||2.57|1.06|
74053890|NCT01682876|147658997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.37|||||TWO_SIDED|95.0|0.99|1.89||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced myalgia in the two doses versus in the one dose of MenACWY-CRM||1.89|0.99|
74053891|NCT01682876|147658997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.07|||||TWO_SIDED|95.0|0.97|4.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced arthralgia in the two doses versus in the one dose of MenACWY-CRM||4.42|0.97|
74053892|NCT01682876|147658997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.83|||||TWO_SIDED|95.0|1.22|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced headache in the two doses versus in the one dose of MenACWY-CRM||2.74|1.22|
74053893|NCT01682876|147658997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.48|2.68||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM||2.68|0.48|
74053894|NCT03852901|147659002|OTHER||Mean Difference (Final Values)|40.717|STANDARD_ERROR_OF_MEAN|4.866|<|0.001|TWO_SIDED|95.0|31.166|50.268||Type III of fixed effects. Num df = 1; Den df = 902.758; F = 70.003; Sig. \< 0.001 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||50.268|31.166|<0.001
74053895|NCT03852901|147659003|OTHER||Mean Difference (Final Values)|-0.637|STANDARD_ERROR_OF_MEAN|1.051||0.545|TWO_SIDED|95.0|-2.699|1.426||Type III of fixed effects. Num df = 1; Den df = 884.229; F = .367; Sig = .545 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||1.426|-2.699|0.545
74053896|NCT03852901|147659004|OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.009||0.003|TWO_SIDED|95.0|0.009|0.044||Type III of fixed effects. Num df = 1; Den df = 880.629; F = 8.782; Sig. = 0.003 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||.044|.009|0.003
74053897|NCT03852901|147659005|OTHER||Mean Difference (Final Values)|-2.647|STANDARD_ERROR_OF_MEAN|1.329||0.047|TWO_SIDED|95.0|-5.255|-0.04||Type III of fixed effects. Num df = 1; Den df = 880.870; F = 3.970; Sig. = 0.047 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||-0.040|-5.255|0.047
74053898|NCT03852901|147659006|OTHER||Mean Difference (Final Values)|-5.573|STANDARD_ERROR_OF_MEAN|1.853||0.003|TWO_SIDED|95.0|-9.21|-1.937||Type III of fixed effects. Num df = 1; Den df = 902.181; F = 9.049; Sig. = 0.003 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: repeated-measures. Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||-1.937|-9.210|0.003
74053899|NCT03852901|147659007|OTHER|||||||0.5849||||||Type III of fixed effects. Num df: 2; Den df = 33; F = 0.5451; Sig. = 0.5849 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age, fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.5849
74053900|NCT03852901|147659008|OTHER|||||||0.0142||||||Type III of fixed effects. Num df = 2; Den df = 35; F = 4.8191; Sig. = 0.0142 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age, fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.0142
74053901|NCT03852901|147659009|OTHER|||||||0.024||||||Type III of fixed effects. Num df: 2; Den df = 34; F = 4.1501; Sig. = 0.0244 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effects: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age and fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.024
74053902|NCT02534324|147659011|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Chi-squared|||||||0.49
74053903|NCT02534324|147659012|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
74053904|NCT00784225|147659035|SUPERIORITY||Cox Proportional Hazard|0.75||||0.52|TWO_SIDED|95.0|0.32|1.79|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for selenium||1.79|0.32|0.52
74053905|NCT00784225|147659035|SUPERIORITY||Cox Proportional Hazard|0.75||||0.51|TWO_SIDED|95.0|0.31|1.77|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for vitamin E||1.77|0.31|0.51
74053906|NCT00784225|147659036|SUPERIORITY||Cox Proportional Hazard|0.91||||0.37|TWO_SIDED|95.0|0.75|1.11|||Regression, Cox|||||1.11|0.75|0.37
74053907|NCT00784225|147659036|SUPERIORITY||Cox Proportional Hazard|1.02||||0.81|TWO_SIDED|95.0|0.84|1.25|||Regression, Cox|||||1.25|0.84|0.81
74053908|NCT00784225|147659037|SUPERIORITY||Cox Proportional Hazard|2.5||||0.12|TWO_SIDED|95.0|0.79|7.98|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for selenium||7.98|0.79|0.12
74053909|NCT00784225|147659037|SUPERIORITY||Cox Proportional Hazard|0.99||||0.98|TWO_SIDED|95.0|0.35|2.82|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for vitamin E||2.82|0.35|0.98
74053910|NCT00784225|147659038|SUPERIORITY||Cox Proportional Hazard|0.84||||0.19|TWO_SIDED|95.0|0.64|1.09|||Regression, Cox|||||1.09|0.64|0.19
74053911|NCT00784225|147659038|SUPERIORITY||Cox Proportional Hazard|1.08||||0.58|TWO_SIDED|95.0|0.83|1.41|||Regression, Cox|||||1.41|0.83|0.58
74053912|NCT01491802|147659059|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.090
74053913|NCT01491802|147659060|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.680
74053914|NCT01491802|147659061|SUPERIORITY|||||||0.197|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.197
74053915|NCT01491802|147659062|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.006
74053916|NCT01491802|147659063|SUPERIORITY|||||||0.044|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.044
74053917|NCT01491802|147659064|SUPERIORITY|||||||0.573|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.573
74053918|NCT01491802|147659065|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.960
74053919|NCT01491802|147659066|SUPERIORITY|||||||0.944|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.944
74053920|NCT01491802|147659067|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.028
74053921|NCT03993314|147659069|SUPERIORITY|||||||0.757||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients achieving a level of numbness of T6 or higher between the two groups.||||0.757
74019508|NCT04233229|147591392|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and total daily insulin dose at selection|Adjusted means difference|-18.5|STANDARD_ERROR_OF_MEAN|28.5||0.52|TWO_SIDED|95.0|-78.2|41.2||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||41.2|-78.2|0.52
74053922|NCT03993314|147659070|SUPERIORITY|||||||0.186||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median level of numbness between the two groups.||||0.186
74053923|NCT03993314|147659071|SUPERIORITY|||||||0.132||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring epidural activation between the two groups.||||0.132
74053924|NCT03993314|147659072|SUPERIORITY|||||||0.833||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring supplemental IV sedation or general anesthesia between the two groups.||||0.833
74053925|NCT03993314|147659073|SUPERIORITY|||||||0.004||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.||||0.004
74053926|NCT03993314|147659074|SUPERIORITY|||||||0.674||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.||||0.674
74100095|NCT03452137|147749296|SUPERIORITY||Difference in Event Free Rate|-1.07||||0.8924|TWO_SIDED|95.0|-16.56|14.42|||Z test|||Difference in OS Event-Free Rates at 5 years||14.42|-16.56|0.8924
74100096|NCT01371747|147749302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74100097|NCT01371747|147749302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74019509|NCT04233229|147591393|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and body weight at study initiation visit|Adjusted means difference|2.8|STANDARD_ERROR_OF_MEAN|1.6||0.08|TWO_SIDED|95.0|-0.4|6.1||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||6.1|-0.4|0.08
74019510|NCT00927368|147591413|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-0.16|||<|0.001|TWO_SIDED|95.0|-0.61|0.29||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.||0.29|-0.61|< 0.001
74019511|NCT00927368|147591413|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.16||||0.03|TWO_SIDED|95.0|-0.29|0.61||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.||0.61|-0.29|0.03
74053927|NCT03993314|147659075|SUPERIORITY|||||||0.196|||||||Log Rank|||Log-rank test of the null hypothesis that there is no difference in the time to discharge from the Post Anesthesia Care Unit (PACU) between the two groups.||||0.196
74053928|NCT01347931|147659083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|7.0|<|0.05|TWO_SIDED|95.0|2.0|10.0|||t-test, 2 sided|||A sample size of 26 patient pairs was determined based on the assumption of a true treatment difference in mean ADL endurance time of 4 ± 7 minutes using a two-tailed, paired t test (α=0.05, power=0.80).||10|2|<0.05
74053929|NCT01347931|147659084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|4.0|<|0.05|TWO_SIDED|95.0|1.0|7.0|||t-test, 2 sided|||Two-tailed t test||7|1|<0.05
74053930|NCT01020812|147659177|SUPERIORITY_OR_OTHER||proportion of participants|0.286|||||TWO_SIDED|95.0|0.031|0.636|||||The data was analyzed in a competing risk model with death as a competing risk. The proportion of 0.286 is the cumulative incidence function at 12 months.|The data was analyzed in a competitive risk model with the cumulative incidence function as the estimator. Death and other progression were competitive risks.||0.636|0.031|
74053931|NCT01020812|147659178|SUPERIORITY_OR_OTHER||probability|0.4|||||TWO_SIDED||||||||This is the overall survival probability at 18 months.|The data was analyzed using the Kaplan Meier estimator.||||
74053932|NCT02528643|147659181|SUPERIORITY||Hazard Ratio (HR)|1.146||||0.248|TWO_SIDED|95.0|0.774|1.696||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by geographic region and ECOG performance status. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.||1.696|0.774|0.248
74053933|NCT02528643|147659181|SUPERIORITY||Hazard Ratio (HR)|1.142||||0.252|TWO_SIDED|95.0|0.773|1.688||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.||1.688|0.773|0.252
74053934|NCT02528643|147659186|SUPERIORITY||Hazard Ratio (HR)|1.039||||0.396|TWO_SIDED|95.0|0.732|1.474||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by ECOG performance status and region. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.||1.474|0.732|0.396
74053935|NCT02528643|147659186|SUPERIORITY||Hazard Ratio (HR)|0.959||||0.586|TWO_SIDED|95.0|0.684|1.345||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.||1.345|0.684|0.586
74053936|NCT04051320|147659202|SUPERIORITY||F statistic|2.164||||0.16|TWO_SIDED||||||repeated measures ANOVA|||||||0.160
74053937|NCT04051320|147659203|SUPERIORITY||F statistic|1.74||||0.1922|TWO_SIDED||||||ANOVA|||||||0.1922
74053938|NCT04051320|147659204|SUPERIORITY||F statistic|0.837||||0.368|TWO_SIDED||||||ANOVA|||||||0.368
74053939|NCT04051320|147659205|SUPERIORITY||F statistic|0.23||||0.881|TWO_SIDED||||||ANOVA|||||||0.881
74053940|NCT04051320|147659206|SUPERIORITY||F statistic|16.541||||0.000723|TWO_SIDED||||||ANOVA|||||||0.000723
74053941|NCT04051320|147659207|SUPERIORITY||F statistic|0.072||||0.791|TWO_SIDED||||||ANOVA|||||||0.791
74100098|NCT01371747|147749302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74053942|NCT04051320|147659208|SUPERIORITY||F statistic|4.952||||0.0372|TWO_SIDED||||||ANOVA|||||||0.0372
74053943|NCT04051320|147659209|SUPERIORITY||F statistic|3.258||||0.0861|TWO_SIDED||||||ANOVA|||||||0.0861
74053944|NCT04051320|147659210|SUPERIORITY||F statistic|2.37||||0.139|TWO_SIDED||||||ANOVA|||||||0.139
74053945|NCT04051320|147659211|SUPERIORITY||F statistic|1.484||||0.237|TWO_SIDED||||||ANOVA|||||||0.237
74053946|NCT04051320|147659212|SUPERIORITY||F statistic|0.013||||0.91|TWO_SIDED||||||ANOVA|||||||0.910
74053947|NCT04051320|147659213|SUPERIORITY||F statistic|4.609||||0.0449|TWO_SIDED||||||ANOVA|||||||0.0449
74053948|NCT04051320|147659214|SUPERIORITY|||||||0.322|||||||Pearson's Correlation Coefficient|||||||0.322
74053949|NCT04051320|147659214|SUPERIORITY|||||||0.772|||||||Pearson's Correlation Coefficient|||||||0.772
74053950|NCT04051320|147659215|SUPERIORITY||Pearson's r|-0.568314||||0.068|TWO_SIDED||||||Pearson correlation|||||||0.068
74053951|NCT04051320|147659215|SUPERIORITY||Pearson's r|-0.082904||||0.8759289|TWO_SIDED||||||Pearson correlation|||||||0.8759289
74053952|NCT04051320|147659216|SUPERIORITY||Pearson's r|-0.1275539||||0.70859639|TWO_SIDED||||||Pearson correlation|||||||0.70859639
74053953|NCT04051320|147659216|SUPERIORITY||Pearson's r|0.49225646||||0.2617744|TWO_SIDED||||||Pearson correlation|||||||0.2617744
74053954|NCT04051320|147659217|SUPERIORITY|||||||0.568|||||||Pearson's Correlation Coefficient|||||||0.568
74053955|NCT04051320|147659217|SUPERIORITY|||||||0.944|||||||Pearson's Correlation Coefficient|||||||0.944
74053956|NCT04051320|147659218|SUPERIORITY|||||||0.103|||||||Pearson's Correlation Coefficient|||||||0.103
74053957|NCT03547960|147659234|SUPERIORITY|||||||0.639|||||||Chi-squared|||||||0.639
74053958|NCT03547960|147659234|SUPERIORITY|||||||0.283|||||||Wilcoxon (Mann-Whitney)|||||||0.283
74053959|NCT03547960|147659236|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||||||0.564
74053960|NCT00529152|147659238|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Regression, Linear|||Change in Serum Ferritin from baseline to week 24 was compared using regression analysis; null hypothesis was defined as no change in serum ferritin from baseline to week 24||||0.0005
74100099|NCT01371747|147749302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74100100|NCT01371747|147749302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74053961|NCT01535638|147659249|SUPERIORITY_OR_OTHER||Ratio (%)|123.4|STANDARD_DEVIATION|17.1|||TWO_SIDED|90.0|108.0|141.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|Relative bioavailability comparison of Deleobuvir Trial Formulation II (reference) and Deleobuvir Final Formulation (test) in pairwise comparison. (reference : test)||141.1|108.0|
74053962|NCT01535638|147659249|SUPERIORITY_OR_OTHER||Ratio (%)|109.8|STANDARD_DEVIATION|28.8|||TWO_SIDED|90.0|88.6|136.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (reference : test)||136.1|88.6|
74053963|NCT01535638|147659250|SUPERIORITY_OR_OTHER||Ratio (%)|122.5|STANDARD_DEVIATION|16.1|||TWO_SIDED|90.0|107.9|139.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation (test) and Deleobuvir Trial Formulation II (reference) in pairwise comparison. (test : reference)||139.1|107.9|
74053964|NCT01535638|147659250|SUPERIORITY_OR_OTHER||Ratio (%)|107.6|STANDARD_DEVIATION|35.0|||TWO_SIDED|90.0|83.1|139.4|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (test : reference)||139.4|83.1|
74053965|NCT00620815|147659266|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Group Mean Ratio|1.13|||||TWO_SIDED|96.67|1.02|1.25||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.25|1.02|
74053966|NCT00620815|147659266|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.01|||||TWO_SIDED|96.67|0.91|1.12||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.12|0.91|
74053967|NCT00620815|147659266|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratio|0.89|||||TWO_SIDED|96.67|0.8|0.99||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1)Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||0.99|0.80|
74053968|NCT00620815|147659266|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.19|||||TWO_SIDED|96.67|0.74|1.93||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.93|0.74|
74053969|NCT00620815|147659266|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.85|||||TWO_SIDED|96.67|0.52|1.38||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.38|0.52|
74053970|NCT00620815|147659266|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.71|||||TWO_SIDED|96.67|0.44|1.15||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.15|0.44|
74053971|NCT00620815|147659266|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.14|||||TWO_SIDED|96.67|1.01|1.3||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.30|1.01|
74053972|NCT00620815|147659266|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.05|||||TWO_SIDED|96.67|0.93|1.19||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.19|0.93|
74053973|NCT00620815|147659266|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.92|||||TWO_SIDED|96.67|0.81|1.04||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.04|0.81|
74053974|NCT00877929|147659276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.2|-7.9|0.0001
74053975|NCT00877929|147659277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1||||0.0001||95.0|-8.9|-5.4|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-5.4|-8.9|0.0001
74053976|NCT00877929|147659278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.0001||95.0|-8.3|-4.9|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.9|-8.3|0.0001
74053977|NCT00877929|147659279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.3|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.3|-7.9|0.0001
74053978|NCT00877929|147659280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0001||95.0|-6.6|-3.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-3.2|-6.6|0.0001
74053979|NCT00689728|147659317|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Fisher Exact|||||||0.178
74053980|NCT00689728|147659317|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
74053981|NCT00689728|147659319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.873||||0.062||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Physical Health Component scores.|ANCOVA|||||||0.062
74053982|NCT00689728|147659319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.427||||0.052||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Physical Health Component scores.|ANCOVA|||||||0.052
74053983|NCT00689728|147659319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.655||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Mental Health Component scores.|ANCOVA|||||||0.655
74053984|NCT00689728|147659319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.264||||0.173||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Mental Health Component scores.|ANCOVA|||||||0.173
74053985|NCT00689728|147659320|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||Fisher Exact|||||||0.281
74053986|NCT00689728|147659320|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||Fisher Exact|||||||0.218
74053987|NCT00689728|147659321|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||||||0.500
74053988|NCT00689728|147659321|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||Fisher Exact|||||||0.444
74053989|NCT00689728|147659322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.337||95.0|||||ANCOVA|||||||0.337
74053990|NCT00689728|147659322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.038||95.0|||||ANCOVA|||||||0.038
74053991|NCT00689728|147659323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.403||95.0|||||ANCOVA|||||||0.403
74053992|NCT00689728|147659323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.006||95.0|||||ANCOVA|||||||0.006
74053993|NCT00689728|147659324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2||||0.168||95.0|||||ANCOVA|||||||0.168
74053994|NCT00689728|147659324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3||||0.075||95.0|||||ANCOVA|||||||0.075
74053995|NCT00689728|147659325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3||||0.157||95.0|||||ANCOVA|||||||0.157
74053996|NCT00689728|147659325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.6||||0.025||95.0|||||ANCOVA|||||||0.025
74100101|NCT01371747|147749302|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74053997|NCT00689728|147659326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4||||0.11||95.0|||||ANCOVA|||||||0.110
74053998|NCT00689728|147659326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1||||0.147||95.0|||||ANCOVA|||||||0.147
74053999|NCT00689728|147659327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172||||0.969||95.0|||||ANCOVA|||||||0.969
74054000|NCT00689728|147659327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.452||95.0|||||ANCOVA|||||||0.452
74054001|NCT00689728|147659328|SUPERIORITY_OR_OTHER|||||||0.554||95.0|||||ANCOVA|||||||0.554
74054002|NCT00689728|147659328|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANCOVA|||||||0.920
74054003|NCT00689728|147659329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.912||||0.1||95.0|||||ANCOVA|||||||0.100
74054004|NCT00689728|147659329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.322||||0.005||95.0|||||ANCOVA|||||||0.005
74054005|NCT00689728|147659330|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||p-value represents comparison of LY2127399-30 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact|||||||0.022
74054006|NCT00689728|147659330|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value represents comparison of LY2127399-80 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact|||||||0.016
74054007|NCT00689728|147659331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.818||95.0|||||ANCOVA|||||||0.818
74054008|NCT00689728|147659331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7||||0.066||95.0|||||ANCOVA|||||||0.066
74054009|NCT00689728|147659332|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|||||||0.010
74054010|NCT00689728|147659332|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|||||||0.056
74054011|NCT00689728|147659333|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
74054012|NCT00689728|147659333|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||||||0.015
74054013|NCT00689728|147659334|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA|||||||0.146
74054014|NCT00689728|147659334|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA|||||||0.125
74054015|NCT00689728|147659334|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA|||||||<0.001
74054016|NCT00689728|147659334|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA|||||||0.005
74054017|NCT00689728|147659334|SUPERIORITY_OR_OTHER|||||||0.115||95.0||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA|||||||0.115
74054018|NCT00689728|147659334|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA|||||||0.019
74100102|NCT01371747|147749303|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74100103|NCT01371747|147749303|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74100104|NCT01371747|147749303|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74054019|NCT00280059|147659368|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin for the proportion of seizure free participants set at 10%; non-inferiority declared if the lower bound of the 95% confidence interval (CI) of the difference in seizure-free proportion between pregabalin and lamotrigine was no more than 10% in favor of lamotrigine, but 0 was contained within the lower bound of the CI. Interpretation of superiority required lower bound of CI did not contain 0 in favor of pregabalin.|Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.24|-0.09|||Gart and Nam: correction of skewness||95% confidence interval for the true difference in proportions, as well as a one-sided test at α=0.025; confidence interval adjusted for centers clustered within a geographical region, with upper and lower confidence limits.|Analysis of the binary response variable for 6 consecutive months seizure freedom analyzed by comparing the proportions of favorable responders between the two treatment groups after stratifying by clusters and correcting for skewness (Gart and Nam, 1990). Percentage can be obtained by multiplying proportion by 100.||-0.09|-0.24|
74054020|NCT00280059|147659369|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.74||||0.0034|TWO_SIDED|95.0|0.6|0.9||Nominal value for 2-sided test calculated using Cox proportional hazards model, adjusted for geographic regions.|Regression, Cox|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \> 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||0.90|0.60|0.0034
74054021|NCT00280059|147659370|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.06||||0.8047|TWO_SIDED|95.0|0.65|1.74||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.74|0.65|0.8047
74054022|NCT00280059|147659371|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19||||0.2537|TWO_SIDED|95.0|0.88|1.6||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.60|0.88|0.2537
74054023|NCT00280059|147659372|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|6.52||||0.0025|TWO_SIDED|95.0|1.93|22.04||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||22.04|1.93|0.0025
74054024|NCT00280059|147659373|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.36||||0.0744|TWO_SIDED|95.0|0.97|1.91||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.91|0.97|0.0744
74054025|NCT00280059|147659374|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.47||||0.0003|TWO_SIDED|95.0|1.19|1.8||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.80|1.19|0.0003
74054026|NCT00280059|147659384|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.0025|TWO_SIDED|95.0|0.3|1.4|||ANCOVA|||Anxiety; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.||1.4|0.3|0.0025
74054027|NCT00280059|147659384|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.0186|TWO_SIDED|95.0|0.1|1.1|||ANCOVA|||Depression; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.||1.1|0.1|0.0186
74054028|NCT00280059|147659385|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.0683|TWO_SIDED|95.0|0.98|1.93|||Regression, Logistic|||Week 8: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.93|0.98|0.0683
74054029|NCT00280059|147659385|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.5096|TWO_SIDED|95.0|0.78|1.66|||Regression, Logistic|||Week 32: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.66|0.78|0.5096
74054030|NCT00280059|147659385|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.6804|TWO_SIDED|95.0|0.73|1.63|||Regression, Logistic|||Week 56 (termination): dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.63|0.73|0.6804
74054031|NCT00951912|147659444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7981|STANDARD_ERROR_OF_MEAN|2.422|<|0.05|TWO_SIDED|95.0|-6.6569|5.0607|||ANOVA|||"Null hypothesis: There are no difference in the difference of changes in plasma glucose.~Power calculation: The sample size of 55 subjects per group provided about 90% power to detect a significant change in the FG concentration of 8 mg/dL (7%) by using a general assumption of a 2-tailed a level of 0.05 and allowing for a 20% withdrawal rate."||5.0607|-6.6569|<0.05
74054032|NCT00951912|147659444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0842|STANDARD_ERROR_OF_MEAN|2.411|<|0.05|TWO_SIDED|95.0|-2.7486|8.9171|||ANOVA|||||8.9171|-2.7486|<0.05
74054033|NCT00951912|147659444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.8823|STANDARD_ERROR_OF_MEAN|2.399|<|0.05|TWO_SIDED|95.0|-1.9234|9.6881|||ANOVA|||||9.6881|-1.9234|<0.05
74054034|NCT00951912|147659445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7696|STANDARD_ERROR_OF_MEAN|4.2|<|0.05|TWO_SIDED|95.0|-11.9308|8.3916|||ANOVA|||||8.3916|-11.9308|<0.05
74054035|NCT00951912|147659445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6929|STANDARD_ERROR_OF_MEAN|4.1818|<|0.05|TWO_SIDED|95.0|-9.4232|10.8091|||ANOVA|||||10.8091|-9.4232|<0.05
74054036|NCT00951912|147659445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4626|STANDARD_ERROR_OF_MEAN|4.1624|<|0.05|TWO_SIDED|95.0|-7.6067|12.5318|||ANOVA|||||12.5318|-7.6067|<0.05
74054037|NCT00951912|147659446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01174|STANDARD_ERROR_OF_MEAN|1.45967|<|0.05|TWO_SIDED|95.0|-3.5428|3.5194|||ANOVA|||||3.5194|-3.5428|<0.05
74054038|NCT00951912|147659446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.68659|STANDARD_ERROR_OF_MEAN|1.4532|<|0.05|TWO_SIDED|95.0|-6.202|0.8288|||ANOVA|||||0.8288|-6.2020|<0.05
74054039|NCT00951912|147659446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.67485|STANDARD_ERROR_OF_MEAN|1.44646|<|0.05|TWO_SIDED|95.0|-6.174|0.8243|||ANOVA|||||0.8243|-6.174|<0.05
74054040|NCT00951912|147659447|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9661|STANDARD_ERROR_OF_MEAN|3.14977|<|0.05|TWO_SIDED|95.0|-10.5857|4.6535|||ANOVA|||||4.6535|-10.5857|<0.05
74054041|NCT00951912|147659447|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.9972|STANDARD_ERROR_OF_MEAN|3.13581|<|0.05|TWO_SIDED|95.0|-8.583|6.5886|||ANOVA|||||6.5886|-8.5830|<0.05
74054042|NCT00951912|147659447|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.9689|STANDARD_ERROR_OF_MEAN|3.12126|<|0.05|TWO_SIDED|95.0|-5.5817|9.5195|||ANOVA|||||9.5195|-5.5817|<0.05
74054043|NCT00951912|147659448|SUPERIORITY_OR_OTHER||Mean Rank|1.442|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
74054044|NCT00951912|147659449|SUPERIORITY_OR_OTHER||Mean Ranks|1.895|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
74054045|NCT00951912|147659450|SUPERIORITY_OR_OTHER||Mean Ranks|2.169|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
74054046|NCT00951912|147659451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.437|STANDARD_ERROR_OF_MEAN|4.9113|<|0.05|TWO_SIDED|95.0|-8.444|15.318|||ANOVA|||||15.318|-8.444|<0.05
74100105|NCT01371747|147749303|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74100106|NCT01371747|147749303|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74054047|NCT00951912|147659451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4809|STANDARD_ERROR_OF_MEAN|4.8896|<|0.05|TWO_SIDED|95.0|-8.3475|15.3092|||ANOVA|||||15.3092|-8.3475|<0.05
74054048|NCT00951912|147659451|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0439|STANDARD_ERROR_OF_MEAN|4.8669|<|0.05|TWO_SIDED|95.0|-11.7296|11.8174|||ANOVA|||||11.8174|-11.7296|<0.05
74054049|NCT00951912|147659452|SUPERIORITY_OR_OTHER||Mean ranks|1.031|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
74054050|NCT00951912|147659453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8185|STANDARD_ERROR_OF_MEAN|3.2343|<|0.05|TWO_SIDED|95.0|-6.0057|9.6426|||ANOVA|||||9.6426|-6.0057|<0.05
74054051|NCT00951912|147659453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0276|STANDARD_ERROR_OF_MEAN|3.2199|<|0.05|TWO_SIDED|95.0|-6.7619|8.817|||ANOVA|||||8.8170|-6.7619|<0.05
74054052|NCT00951912|147659453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7909|STANDARD_ERROR_OF_MEAN|3.205|<|0.05|TWO_SIDED|95.0|-8.5442|6.9624|||ANOVA|||||6.9624|-8.5442|<0.05
74054053|NCT00951912|147659454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0122|STANDARD_ERROR_OF_MEAN|4.1686|<|0.05|TWO_SIDED|95.0|-8.0721|12.0964|||ANOVA|||||12.0964|-8.0721|<0.05
74054054|NCT00951912|147659454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7716|STANDARD_ERROR_OF_MEAN|4.1501|<|0.05|TWO_SIDED|95.0|-10.8111|9.2679|||ANOVA|||||9.2679|-10.8111|<0.05
74054055|NCT00951912|147659454|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7837|STANDARD_ERROR_OF_MEAN|4.1309|<|0.05|TWO_SIDED|95.0|-12.7767|7.2092|||ANOVA|||||7.2092|-12.7767|<0.05
74054056|NCT00951912|147659455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4437|STANDARD_ERROR_OF_MEAN|0.1001|<|0.05|TWO_SIDED|95.0|-0.6416|-0.2458|||ANOVA|||||-0.2458|-0.6416|<0.05
74054057|NCT00951912|147659455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1986|STANDARD_ERROR_OF_MEAN|0.09986|<|0.05|TWO_SIDED|95.0|-0.3956|-0.0016|||ANOVA|||||-0.0016|-0.3956|<0.05
74054058|NCT00951912|147659455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2451|STANDARD_ERROR_OF_MEAN|0.09648|<|0.05|TWO_SIDED|95.0|0.0544|0.4358|||ANOVA|||||0.4358|0.0544|<0.05
74054059|NCT00951912|147659456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6353|STANDARD_ERROR_OF_MEAN|0.1146|<|0.05|TWO_SIDED|95.0|-0.8617|-0.4089|||ANOVA|||||-0.4089|-0.8617|<0.05
74054060|NCT00951912|147659456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0282|STANDARD_ERROR_OF_MEAN|0.1156||0.05|TWO_SIDED|95.0|-0.2003|0.2568|||ANOVA|||||0.2568|-0.2003|0.05
74054061|NCT00951912|147659456|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6635|STANDARD_ERROR_OF_MEAN|0.1121|<|0.05|TWO_SIDED|95.0|0.4419|0.8851|||ANOVA|||||0.8851|0.4419|<0.05
74054062|NCT00951912|147659457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1557|STANDARD_ERROR_OF_MEAN|0.119|<|0.05||95.0|-0.3911|0.0796|||ANOVA|||||0.0796|-0.3911|<0.05
74054063|NCT00951912|147659457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.606|STANDARD_ERROR_OF_MEAN|0.119||0.05|TWO_SIDED|95.0|-0.8414|-0.3707|||ANOVA|||||-0.3707|-0.8414|0.05
74054064|NCT00951912|147659457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4503|STANDARD_ERROR_OF_MEAN|0.1163|<|0.05|TWO_SIDED|95.0|-0.6804|-0.2202|||ANOVA|||||-0.2202|-0.6804|<0.05
74054065|NCT00951912|147659458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|102.4|STANDARD_ERROR_OF_MEAN|83.4|<|0.05|TWO_SIDED|95.0|-99.3|304.1|||ANOVA|||||304.1|-99.3|<0.05
74054066|NCT00951912|147659458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|82.6||0.05|TWO_SIDED|95.0|-203.7|196.1|||ANOVA|||||196.1|-203.7|0.05
74054067|NCT00951912|147659458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-106.2|STANDARD_ERROR_OF_MEAN|82.2|<|0.05|TWO_SIDED|95.0|-305.1|92.8|||ANOVA|||||92.8|-305.1|<0.05
74054068|NCT02612194|147659522|OTHER|Estimation only.|Overall Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.369|||||Confidence interval estimated using the Clopper Pearson method.|||0.369|0.000|
74100107|NCT01371747|147749303|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74100108|NCT01371747|147749304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74100109|NCT01371747|147749304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74054069|NCT02612194|147659523|OTHER|Estimation only|Median|3.1|||||TWO_SIDED|95.0|0.2|6.1|||||The Kaplan Meier method was used to estimate the median OS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.|||6.1|0.2|
74054070|NCT02612194|147659524|OTHER|Estimation only|Median|1.5|||||TWO_SIDED|95.0|0.2|1.8|||||The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||1.8|0.2|
74054071|NCT00149227|147659525|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|-0.975|0.975|||Cox's proportional hazard analysis|||"We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.~with a two-tailed 5% statistical signiﬁcant level."||0.975|-0.975|<0.05
74054072|NCT02539160|147659539|SUPERIORITY||Median Difference (Net)|6.4||||0.105|TWO_SIDED|95.0|-1.1|14.3|||t-test, 2 sided|||||14.3|-1.1|0.105
74054073|NCT02539160|147659539|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.112|TWO_SIDED|95.0|-1.5|13.7|||t-test, 2 sided|||||13.7|-1.5|0.112
74054074|NCT02828982|147659566|SUPERIORITY|||||||0.585||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||The null hypothesis was that there would be no difference in metabolic costs between the two groups||||0.585
74054075|NCT02828982|147659567|SUPERIORITY|||||||0.452||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||The null hypothesis was that there were no differences in the number of steps taken outside of the home for the two prostheses.||||0.452
74054076|NCT02828982|147659568|OTHER|paired t-test of Physical component scores between the two conditions||||||0.48||||||a prior threshold for significance was 0.05|t-test, 2 sided|||||||0.480
74054077|NCT02828982|147659568|SUPERIORITY|||||||0.408||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||Mental Component Score||||0.408
74054078|NCT02828982|147659569|SUPERIORITY|||||||0.058||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Ambulation Score||||0.058
74054079|NCT02828982|147659569|OTHER|paired t-test between conditions||||||0.123||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Appearance Score||||.123
74054080|NCT02828982|147659569|OTHER|paired t-test between conditions||||||0.052||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Frustration Score||||.052
74054081|NCT02828982|147659569|OTHER|paired t-test between conditions||||||0.188||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Perceived Response Score||||.188
74054082|NCT02828982|147659569|OTHER|paired t-test between conditions||||||0.336||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Limb Health Score||||.336
74054083|NCT02828982|147659569|OTHER|paired t-test between conditions||||||0.043||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Social Burden Score||||.043
74054084|NCT02828982|147659569|OTHER|paired t-test between conditions||||||0.391||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Sounds Score||||.391
74054085|NCT02828982|147659569|SUPERIORITY|paired t-test between conditions||||||0.799||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Utility Score||||.799
74054086|NCT02828982|147659569|SUPERIORITY|||||||0.173||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Well-Being||||.173
74054087|NCT02828982|147659570|OTHER|paired t-test between conditions||||||0.655||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Biceps Femoris||||0.655
74054088|NCT02828982|147659570|OTHER|paired t-test between conditions||||||0.281||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Rectus Femoris||||.281
74054089|NCT02828982|147659570|OTHER|paired t-test between conditions||||||0.844||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Soleus||||.844
74054090|NCT02828982|147659570|OTHER|paired t-test between conditions||||||0.11||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Tibialis Anterior||||.110
74054091|NCT02828982|147659570|OTHER|paired t-test between conditions||||||0.394||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Side Biceps Femoris||||.394
74054092|NCT02828982|147659570|SUPERIORITY|||||||0.141||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Side Rectus Femoris||||.141
74054093|NCT02828982|147659571|SUPERIORITY|||||||0.212||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||||||0.212
74054094|NCT02312934|147659576|OTHER||||||=|0.41||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p \< 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Primary Aim (Specific Aim 1), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline PCI FACT-Cog score (Visit 3, Visit 4, and Visit 5) as the dependent measure.||||=0.41
74054095|NCT02312934|147659577|OTHER|||||||0.79||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p \< 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Secondary Aim (Specific Aim 2), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline CPT Scores (Visit 3, Visit 4, and Visit 5) as the dependent measure.||||0.79
74054096|NCT02978339|147659578|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
74054097|NCT02978339|147659579|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
74054098|NCT02978339|147659580|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||||||0.91
74054099|NCT02978339|147659581|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
74054100|NCT02978339|147659582|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||.15
74054101|NCT02978339|147659583|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||.06
74054102|NCT02978339|147659584|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||.93
74054103|NCT00689299|147659588|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||ANOVA with baseline score as covariate||||<0.05
74054104|NCT03395704|147659651|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||< 0.0001
74054105|NCT00434876|147659657|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Mixed Models Analysis|||||||0.49
74054106|NCT00434876|147659658|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|||||||0.04
74054107|NCT00434876|147659659|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||Mixed Models Analysis|||||||0.57
74054108|NCT00434876|147659660|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||||||0.03
74054109|NCT00758394|147659661|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two way Anova general linear model (subject and treatment as factors). Multiple comparison completed to determine differences between groups.|ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
74054110|NCT00195702|147659667|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.||||<0.001
74054111|NCT00195702|147659667|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.||||<0.001
74054112|NCT00195702|147659668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.||||<0.001
74054113|NCT00195702|147659668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.||||<0.001
74054114|NCT00195702|147659669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74054115|NCT00195702|147659669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74054116|NCT00195702|147659670|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
74054117|NCT00195702|147659670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74054118|NCT00195702|147659671|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74054119|NCT00195702|147659671|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74054120|NCT00195702|147659672|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.||||<0.001
74054121|NCT00195702|147659672|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.||||<0.001
74054122|NCT00195702|147659673|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74054123|NCT00195702|147659673|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74054124|NCT00195702|147659675|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74054125|NCT00195702|147659675|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74054126|NCT00195702|147659679|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74054127|NCT00195702|147659679|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74054128|NCT03539900|147659708|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.44|||||||Mixed Models Analysis|Analyses were performed for all randomized participants. Models also considered weight status as a moderator or predictor.||||||.44
74054129|NCT03539900|147659709|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.04|||||||Mixed Models Analysis|Analyses were performed for all randomized participants. Models also considered weight status as a predictor or moderator.||||||.04
74054130|NCT03539900|147659710|SUPERIORITY|||||||0.98|||||||ANOVA|Analyses used all available data without imputation.||||||.98
74054131|NCT03539900|147659711|SUPERIORITY|||||||0.44|||||||ANOVA|Analyses used all available data without imputation.||||||.44
74054132|NCT03539900|147659712|SUPERIORITY|||||||0.99|||||||ANOVA|Analyses used all available data without imputation.||||||.99
74054133|NCT03539900|147659713|SUPERIORITY|||||||0.4|||||||ANOVA|Analyses used all available data without imputation.||||||.40
74100110|NCT01371747|147749304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74100111|NCT01371747|147749304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74100112|NCT01371747|147749304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74100113|NCT01371747|147749304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
74100114|NCT01371747|147749305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.54|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
74054134|NCT04823494|147659714|NON_INFERIORITY|For sample size in each sequence group is 16 (total N=32), a 2 X 2 crossover design will have 80% power to reject the null hypothesis that the SELF-FIT APHAB mean is inferior to the PRO-FIT APHAB mean. The non-inferiority difference margin is 8.4, the standard deviation of differences is 16.3, and p\<.025. The non-inferiority margin of 8.4 preserves half the 95% critical difference for the global APHAB score (16.8). The common standard deviation reported for the APHAB global score is 16.0.|Mean Difference (Final Values)|1.4|||<|0.025|TWO_SIDED|95.0|-1.59|4.73||There were two outcome measures, primary and secondary, considered. As a result, the a priori p value of .05 for statistical significance was adjusted for multiple comparisons to .025.|t-test, 1 sided|The mean differences and 95% CIs in APHAB global score between SELF-FIT and PRO-FIT were calculated using bias-corrected \& accelerated bootstrapping.|The mean difference and 95% CIs are for Self-Fit minus Pro-Fit aided scores. These values are the pooled data for all 37 participants, 19 receiving one sequence and 18 the other sequence.|"For the wear-time crossover field trial, the APHAB was measured following both the audiology best-practices hearing aid fitting (PRO-FIT) and the self-fitting method (SELF-FIT).~* Null hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT ) ≥ 8.4~* Alternative hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT) \< 8.4~The mean difference between the aided scores for the two fitting methods, Self-Fit minus Pro-Fit, represent the primary outcome measure. The expected difference = 0."||4.73|-1.59|<0.025
74054135|NCT04823494|147659715|NON_INFERIORITY|For the QuickSIN, a clinically meaningful difference is 3 dB and half that difference resulted in a margin of 1.5 dB. This 1.5-dB margin was used for the QuickSIN for the non-inferiority analyses of the data from the field-trial component. The mean difference, QuickSIN Self-Fit minus QuickSIN Pro-Fit, should be less than 1.5 dB for the entire sample (N=37) to meet the non-inferiority criterion.|Mean Difference (Final Values)|0.58|||<|0.025|TWO_SIDED|95.0|-0.03|1.2||The a priori threshold value of 0.05 was Bonferroni-adjusted to 0.025 based on the use of two outcome measures, APHAB global (primary) and QuickSIN (secondary).|t-test, 1 sided|The mean differences in dB, SELF-FIT minus PRO-FIT, were calculated with 95% confidence intervals (bias-corrected, accelerated bootstrap) generated.|Mean differences in aided QuickSIN SNR in dB, Self-Fit minus Pro-Fit, were calculated for the entire group of 37 participants with about 1/2 receiving one of the two fit sequences (Pro-Fit then Self-Fit or Self-Fit then Pro-Fit).|"For the QuickSIN, aided performance after each wear period was compared between SELF-FIT and PRO-FIT.~* Null hypothesis: Mean (QuickSIN SELF-FIT - QuickSIPRO-FIT) ≥ 1.5 dB~* Alternative hypothesis: Mean (QuickSIN SELF-FIT - QuickSIN PRO-FIT) \< 1.5 dB~Power calculations were based on the primary outcome measured, the aided APHAB global score, (see information for that outcome measure). With the minimum required N of 32 based on the APHAB global score, the power for QuickSIN exceeded 80%."||1.20|-0.03|<0.025
74054136|NCT03922945|147659726|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74054137|NCT03922945|147659727|SUPERIORITY||||||<|0.0017|||||||Cochran-Mantel-Haenszel|||||||<0.0017
74054138|NCT03922945|147659734|SUPERIORITY|||||||0.7465|||||||Mixed Models Analysis|||||||0.7465
74054139|NCT01729559|147659757|NON_INFERIORITY_OR_EQUIVALENCE|A 10% noninferiority margin was selected based on a previous trial showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of unfractionated heparin (UFH) every 12 hr. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required.|Risk Difference (RD)|6.5||||0.025|TWO_SIDED|95.0|-2.9|15.8||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|Analysis was performed in a subset of patients who received at least one follow-up venous duplex ultrasound of the lower extremities.||15.8|-2.9|0.025
73881618|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.93||0.0553|TWO_SIDED|95.0|-3.62|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.04|-3.62|0.0553
74054140|NCT01729559|147659757|NON_INFERIORITY_OR_EQUIVALENCE|A 10% noninferiority margin was selected based on these data showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of UFH every 12 hours. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required. This analysis was performed in the entire sample.|Risk Difference (RD)|3.1||||0.025|TWO_SIDED|95.0|-1.6|7.7||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|"Analysis was performed in the total sample of eligible patients and who received their assigned treatment (referred to as the randomized treated sample) ."||7.7|-1.6|0.025
74054141|NCT03764813|147659761|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).||||<0.0001
74054142|NCT03764813|147659762|SUPERIORITY||Median Difference (Final Values)|0.165|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74054143|NCT03764813|147659763|SUPERIORITY||Median Difference (Final Values)|0.537|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74100115|NCT01371747|147749305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
74100116|NCT01371747|147749305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
74100117|NCT01371747|147749305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.0|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
73881619|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.92||0.2753|TWO_SIDED|95.0|-2.82|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.80|-2.82|0.2753
74054144|NCT03764813|147659764|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).||||<0.0001
74054145|NCT01707667|147659765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.012|TWO_SIDED|95.0|1.6|9.9|||Linear Mixed-Effect Models Analysis|||||9.9|1.6|0.012
74054146|NCT01707667|147659766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|69051.4||||0.079|TWO_SIDED|95.0|-12004.5|150107.3|||Linear Mixed-Effect Models Analysis|||||150107.3|-12004.5|0.079
74054147|NCT01707667|147659767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2||||0.717|TWO_SIDED|95.0|-45.3|63.7|||Linear Mixed-Effect Models Analysis|||||63.7|-45.3|0.717
74054148|NCT01707667|147659768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|TWO_SIDED||||||Log Rank|||||||0.295
74054149|NCT01707667|147659769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.179||||0.18|TWO_SIDED|95.0|-0.465|0.107|||Linear Mixed-Effect Models Analysis|||||0.107|-0.465|0.180
74054150|NCT01707667|147659770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.8||||0.225|TWO_SIDED|95.0|-12.6|44.3|||Linear Mixed-Effect Models Analysis|||||44.3|-12.6|0.225
74054151|NCT03432819|147659776|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|9.24||||0.06|TWO_SIDED|95.0|-0.55|19.03|||Regression, Linear|||||19.03|-0.55|0.06
74054152|NCT03432819|147659777|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Final Values)|4.5||||0.02|TWO_SIDED|95.0|0.7|8.3|||Regression, Linear|||||8.30|0.70|0.02
74054153|NCT03432819|147659778|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Final Values)|0.08||||0.39|TWO_SIDED|95.0|-0.1|0.26|||Regression, Linear|||||0.26|-0.10|0.39
74054154|NCT03432819|147659779|SUPERIORITY||Median Difference (Final Values)|-0.09||||0.54|TWO_SIDED|95.0|-0.37|0.2|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.20|-0.37|0.54
74054155|NCT03432819|147659780|SUPERIORITY||Median Difference (Final Values)|-0.02||||0.81|TWO_SIDED|95.0|-0.18|0.14|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.14|-0.18|0.81
74054156|NCT03432819|147659781|SUPERIORITY||Median Difference (Final Values)|-0.18||||0.06|TWO_SIDED|95.0|-0.37|0.01|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.01|-0.37|0.06
74100118|NCT01371747|147749305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.96|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
74054157|NCT03432819|147659782|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.16|TWO_SIDED|95.0|-0.78|0.13|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.13|-0.78|0.16
74054158|NCT03432819|147659783|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.02|TWO_SIDED|95.0|-0.84|-0.09|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||-0.09|-0.84|0.02
74054159|NCT03432819|147659784|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.71|TWO_SIDED|95.0|-0.32|0.47|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.47|-0.32|0.71
74100119|NCT01371747|147749305|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.17|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
74054160|NCT03432819|147659785|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.1|TWO_SIDED|95.0|-0.73|0.06|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.06|-0.73|0.10
74054161|NCT03485976|147659857|OTHER||||||<|0.001||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||||||<0.001
74054162|NCT03485976|147659858|OTHER|||||||0.004||||||The threshold for significance was p=0.05|t-test, 2 sided|||||||0.004
74054163|NCT03485976|147659859|OTHER|||||||0.001||||||Threshold for significance was p=0.05|t-test, 2 sided|||||||0.001
74054164|NCT02242305|147659896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.809|TWO_SIDED|90.0|-0.33|0.27|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 3 days and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.|||0.27|-0.33|0.809
74054165|NCT02242305|147659896|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.809|TWO_SIDED|95.0|-0.39|0.33|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 1 day and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.|||0.33|-0.39|0.809
74054166|NCT02242305|147659897|SUPERIORITY_OR_OTHER|||||||0.079|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.||||||0.079
74054167|NCT02242305|147659902|SUPERIORITY_OR_OTHER|||||||0.531|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline score as covariates was used.||||||0.531
74054168|NCT03451630|147659903|SUPERIORITY|||||||0.0211||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.49 with degrees of freedom (6, 3152).||Overall Test of Group by Time Interaction||||0.0211
74054169|NCT03451630|147659903|SUPERIORITY||Mean Difference (Final Values)|2.69|STANDARD_ERROR_OF_MEAN|1.22||0.028|TWO_SIDED|95.0|0.29|5.09||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 4.83 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to 12-Months using linear contrast.||5.09|0.29|0.0280
74054170|NCT03451630|147659903|SUPERIORITY||Mean Difference (Final Values)|2.07|STANDARD_ERROR_OF_MEAN|1.23||0.0935|TWO_SIDED|95.0|-0.35|4.48||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.81 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to 12-Months using linear contrast.||4.48|-0.35|0.0935
74054171|NCT03451630|147659903|SUPERIORITY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|1.05||0.5538|TWO_SIDED|95.0|-1.44|2.68||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.35 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to12-Months using linear contrast.||2.68|-1.44|0.5538
74054172|NCT03451630|147659904|SUPERIORITY|Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).||||||0.8505|||||||Mixed Models Analysis|F-statistics 0.44 with degrees of freedom (6, 3154).||Overall Test of the Group by Time Interaction||||0.8505
74054173|NCT03451630|147659904|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 16.97 with degrees of freedom (3, 3160).||Test for significant change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
74054174|NCT03451630|147659904|SUPERIORITY|||||||0.8656||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.14 with degrees of freedom (2, 1229).||Test for significant change by treatment when the treatment-by-time interaction effect is not significant.||||0.8656
74054175|NCT03451630|147659904|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.29||0.474|TWO_SIDED|95.0|-1.61|3.46||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.51 with degrees of freedom (1, 3154)||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||3.46|-1.61|0.4740
74054176|NCT03451630|147659904|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|1.26||0.6017|TWO_SIDED|95.0|-1.81|3.13||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.27 with degrees of freedom (1, 3154).||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||3.13|-1.81|0.6017
74100120|NCT01371747|147749306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.36|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
74054177|NCT03451630|147659904|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.99||0.786|TWO_SIDED|95.0|-1.67|2.2||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.07 with degrees of freedom (1, 3154).||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||2.20|-1.67|0.7860
74054178|NCT03451630|147659905|SUPERIORITY|||||||0.59||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.08 with degrees of freedom (2).||Overall Test of Marginal Group Differences||||0.59
74054179|NCT03451630|147659905|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6692|TWO_SIDED|95.0|0.76|2.11||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.8 with degrees of freedom (2).||Test for the Treatment Effect||2.11|0.76|0.6692
74054180|NCT03451630|147659905|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6692|TWO_SIDED|95.0|0.7|1.93||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.80 with degrees of freedom (2).||Test for the Treatment Effect||1.93|0.70|0.6692
74054181|NCT03451630|147659905|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6692|TWO_SIDED|95.0|0.75|1.59||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.8 with degrees of freedom (2).||Test for the Treatment Effect||1.59|0.75|0.6692
74054182|NCT03451630|147659906|SUPERIORITY|||||||0.58||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.08 with degrees of freedom (2).||Overall Test of Marginal Group Differences||||0.58
74054183|NCT03451630|147659906|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7436|TWO_SIDED|95.0|0.43|3.02||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect||3.02|0.43|0.7436
74054184|NCT03451630|147659906|SUPERIORITY||Odds Ratio (OR)|0.84||||0.7436|TWO_SIDED|95.0|0.31|2.25||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect.||2.25|0.31|0.7436
74054185|NCT03451630|147659906|SUPERIORITY||Odds Ratio (OR)|1.36||||0.7436|TWO_SIDED|95.0|0.62|2.97|||Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect.||2.97|0.62|0.7436
74054186|NCT03451630|147659907|SUPERIORITY|||||||0.5558||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.82 with degrees of freedom (6, 3057)||Overall test of treatment-by-time interaction||||0.5558
74054187|NCT03451630|147659907|SUPERIORITY|||||||0.0002||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 6.74 with degrees of freedom (3, 3063).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0002
74054188|NCT03451630|147659907|SUPERIORITY|||||||0.7846||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.24 with degrees of freedom (2,1197).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.7846
74054189|NCT03451630|147659907|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.61||0.2444|TWO_SIDED|95.0|-1.92|0.49||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-Statistics 1.36 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.49|-1.92|0.2444
74054190|NCT03451630|147659907|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.61||0.648|TWO_SIDED|95.0|-1.48|0.92||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.21 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.92|-1.48|0.6480
74054191|NCT03451630|147659907|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.46||0.3476|TWO_SIDED|95.0|-1.34|0.47||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.88 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.47|-1.34|0.3476
74054192|NCT03451630|147659908|SUPERIORITY|||||||0.5199||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.86 with degrees of freedom (6, 3148)||Overall test of treatment-by-time||||0.5199
74054193|NCT03451630|147659908|SUPERIORITY|||||||0.0008||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 5.56 with degrees of freedom (3, 3154).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0008
74054194|NCT03451630|147659908|SUPERIORITY|||||||0.9897||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.01 with degrees of freedom (2,1229).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9897
74054195|NCT03451630|147659908|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.8749|TWO_SIDED|95.0|-0.03|0.03||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.02 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.03|-0.03|0.8749
74054196|NCT03451630|147659908|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.2216|TWO_SIDED|95.0|-0.05|0.01||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.49 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.01|-0.05|0.2216
74054197|NCT03451630|147659908|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.0607|TWO_SIDED|95.0|0.0|0.04||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.52 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.04|0.00|0.0607
74054198|NCT03451630|147659909|SUPERIORITY|||||||0.1884||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.46 with degrees of freedom (6, 3138)||Overall test of treatment-by-time||||0.1884
74054199|NCT03451630|147659909|SUPERIORITY|||||||0.009||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.87 with degrees of freedom (3, 3144).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0090
74054200|NCT03451630|147659909|SUPERIORITY|||||||0.217||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.53 with degrees of freedom (2, 1227).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.2170
74054201|NCT03451630|147659909|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.09||0.191|TWO_SIDED|95.0|-0.06|0.28||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.71 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.28|-0.06|0.1910
74054202|NCT03451630|147659909|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.08||0.0229|TWO_SIDED|95.0|0.03|0.35||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 5.18 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.35|0.03|0.0229
74054203|NCT03451630|147659909|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.2547|TWO_SIDED|95.0|-0.21|0.06||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.30 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.06|-0.21|0.2547
74054204|NCT03451630|147659910|SUPERIORITY|||||||0.0413||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.49 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.0413
74054205|NCT03451630|147659910|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.1433|TWO_SIDED|95.0|-0.28|0.04||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.14 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.04|-0.28|0.1433
74054206|NCT03451630|147659910|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4272|TWO_SIDED|95.0|-0.1|0.23||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.63 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.23|-0.10|0.4272
74054207|NCT03451630|147659910|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.0037|TWO_SIDED|95.0|-0.31|-0.06||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 8.45 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||-0.06|-0.31|0.0037
74054208|NCT03451630|147659911|SUPERIORITY|||||||0.8231||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.38 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.8231
74054209|NCT03451630|147659911|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 330.05 with degrees of freedom (2, 1948).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
74054210|NCT03451630|147659911|SUPERIORITY|||||||0.6061||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.50 with degrees of freedom (2 , 1948).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.6061
74054211|NCT03451630|147659911|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7459|TWO_SIDED|95.0|-0.15|0.11||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.11|-0.15|0.7459
74054212|NCT03451630|147659911|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3169|TWO_SIDED|95.0|-0.18|0.08||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.00 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.08|-0.18|0.3169
74054213|NCT03451630|147659911|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.4098|TWO_SIDED|95.0|-0.07|0.14||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.68 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.14|-0.07|0.4098
74054214|NCT03451630|147659912|SUPERIORITY|||||||0.4732||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.88 with degrees of freedom (4, 1945).||Overall test for the treatment-by-time interaction||||0.4732
74054215|NCT03451630|147659912|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 319.14 with degrees of freedom (2, 1948).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
74054216|NCT03451630|147659912|SUPERIORITY|||||||0.9628||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.04 with degrees of freedom (2, 1948).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9628
74054217|NCT03451630|147659912|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.8438|TWO_SIDED|95.0|-0.16|0.19||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.04 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.19|-0.16|0.8438
74054218|NCT03451630|147659912|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.7425|TWO_SIDED|95.0|-0.19|0.15||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.15|-0.19|0.7425
74054219|NCT03451630|147659912|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.5044|TWO_SIDED|95.0|-0.1|0.17||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.45 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.17|-0.10|0.5044
74054220|NCT03451630|147659913|SUPERIORITY|||||||0.9804||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.9804
74054221|NCT03451630|147659913|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 21.80 with degrees of freedom (2, 3168).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
74054222|NCT03451630|147659913|SUPERIORITY|||||||0.9764||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.02 with degrees of freedom (2, 1211).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9764
74054223|NCT03451630|147659913|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9757|TWO_SIDED|95.0|0.63|1.6||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-test statistics 0.03.||Odds ratio of Treatment at 12-Months||1.60|0.63|0.9757
74054224|NCT03451630|147659913|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7958|TWO_SIDED|95.0|0.67|1.68||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-test statistics 0.26.||Odds ratio of Treatment at 12-Months||1.68|0.67|0.7958
74054225|NCT03451630|147659913|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7646|TWO_SIDED|95.0|0.67|1.34||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.30||Odds ratio of Treatment at 12-Months||1.34|0.67|0.7646
74054226|NCT03451630|147659914|SUPERIORITY|||||||0.9622||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.15 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.9622
74054227|NCT03451630|147659914|SUPERIORITY|||||||0.0377||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.28 with degrees of freedom (2, 3168).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0377
74054228|NCT03451630|147659914|SUPERIORITY|||||||0.83||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistic 0.19 with degrees of freedom (2, 1903).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.8300
74054229|NCT03451630|147659914|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7507|TWO_SIDED|95.0|0.38|2.0||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.32||Odds ratio of Treatment at 12-Months||2.00|0.38|0.7507
74054230|NCT03451630|147659914|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8844|TWO_SIDED|95.0|0.42|2.13||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.15||Odds ratio of Treatment at 12-Months||2.13|0.42|0.8844
74054231|NCT03451630|147659914|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8227|TWO_SIDED|95.0|0.49|1.77||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.22||Odds ratio of Treatment at 12-Months||1.77|0.49|0.8227
74054232|NCT03451630|147659915|OTHER|||||||1|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Frequency and test of the marginal association between event rate and treatment for eligible participants' data at 12 months for MMA-1a||||1.00
74100121|NCT01371747|147749306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.22|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
74054233|NCT03451630|147659915|OTHER|||||||0.242|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Frequency and test of the marginal association between event rate and treatment for eligible participants' data at 12 months for MMA-1b||||0.242
74054234|NCT03451630|147659916|OTHER|||||||0.1112|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Test of the marginal association between event rate and treatment for eligible participants' data at 12 months for PCE-1||||0.1112
74100122|NCT01371747|147749306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.3|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
74100123|NCT01371747|147749306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.41|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
74100124|NCT01371747|147749306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.39|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
74100125|NCT01371747|147749306|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.58|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
73881620|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|0.91||0.514|TWO_SIDED|95.0|-1.2|2.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||2.40|-1.20|0.5140
74054235|NCT03451630|147659916|OTHER|||||||0.4754|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Test of the marginal association between event rate and treatment for eligible participants' data at 12 months for PCE-2||||0.4754
74054236|NCT03451630|147659917|SUPERIORITY||Odds Ratio (OR)|0.74||||0.9079|TWO_SIDED|95.0|0.13|4.28||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||4.28|0.13|0.9079
74054237|NCT03451630|147659917|SUPERIORITY||Odds Ratio (OR)|0.68||||0.9079|TWO_SIDED|95.0|0.13|3.72||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||3.72|0.13|0.9079
74054238|NCT03451630|147659917|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9079|TWO_SIDED|95.0|0.34|3.45||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||3.45|0.34|0.9079
74054239|NCT03451630|147659918|SUPERIORITY|||||||0.9912||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.07 with degrees of freedom (4, 335).||Test for the treatment-by-time interaction (without weight) for SPC-1.||||0.9912
74054240|NCT03451630|147659918|SUPERIORITY|||||||0.876||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.13 with degrees of freedom (2, 339).||Test for change over time for SPC-1||||0.8760
74054241|NCT03451630|147659918|SUPERIORITY|||||||0.678||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.39 with degrees of freedom (2, 276).||Test for change in treatment effect for SPC-1||||0.6780
74054242|NCT03451630|147659918|SUPERIORITY|||||||0.1761||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.59 with degrees of freedom (4, 284).||Test for the treatment-by-time interaction (without weight) for SPC-2||||0.1761
74054243|NCT03451630|147659918|SUPERIORITY|||||||0.3239||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.13 with degrees of freedom (2, 288).||Test for change over time for SPC-2||||0.3239
74054244|NCT03451630|147659918|SUPERIORITY|||||||0.7415||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.30 with degrees of freedom (2, 139).||Test for change in treatment effect for SPC-2||||0.7415
74054245|NCT03451630|147659919|SUPERIORITY|||||||0.9786||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (4, 608).||Test for the treatment-by-time interaction (without weight) for SPD-1.||||0.9786
74054246|NCT03451630|147659919|SUPERIORITY|||||||0.4703||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.76 with degrees of freedom (2, 612).||Test for change over time for SPD-1||||0.4703
74054247|NCT03451630|147659919|SUPERIORITY|||||||0.877||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.13 with degrees of freedom (2, 332).||Test for change in treatment effect for SPD-1||||0.8770
74054248|NCT03451630|147659919|SUPERIORITY|||||||0.6198||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.66 with degrees of freedom (4, 469).||Test for the treatment-by-time interaction (without weight) for SPD-2||||0.6198
74054249|NCT03451630|147659919|SUPERIORITY|||||||0.6211||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.48 with degrees of freedom (2, 473).||Test for change over time for SPD-2||||0.6211
74100126|NCT01371747|147749307|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.3|100.0|||||2-sided 95% exact binomial CI|||100.0|94.3|
74054250|NCT03451630|147659919|SUPERIORITY|||||||0.1471||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.93 with degrees of freedom (2, 219).||Test for change in treatment effect for SPD-2.||||0.1471
74054251|NCT03451630|147659920|SUPERIORITY|||||||0.8247||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.38 with degrees of freedom (4, 280).||Test for the treatment-by-time interaction (without weight) for AMM-1||||0.8247
74054252|NCT03451630|147659920|SUPERIORITY|||||||0.6651||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.41 with degrees of freedom (2, 284).||Test for change over time for AMM-1||||0.6651
74054253|NCT03451630|147659920|SUPERIORITY|||||||0.3441||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.07 with degrees of freedom (2, 218).||Test for change in treatment effect for AMM-1||||0.3441
74054254|NCT03451630|147659920|SUPERIORITY|||||||0.0847||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.07 with degrees of freedom (4, 280).||Test for the treatment-by-time interaction (without weight) for AMM-2||||0.0847
74054255|NCT03451630|147659920|SUPERIORITY|||||||0.9695||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.03 with degrees of freedom (2, 284).||Test for change over time for AMM-2||||0.9695
74054256|NCT03451630|147659920|SUPERIORITY|||||||0.9396||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.06 with degrees of freedom (2, 200).||Test for change in treatment effect for AMM-2||||0.9396
74054257|NCT03503617|147659935|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
74054258|NCT02041533|147659945|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.15||||0.2511|TWO_SIDED|95.0|0.91|1.45|||Log Rank|Log-rank test stratified by histology (squamous vs. non-squamous) as entered into the IVRS.|Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.45|0.91|0.2511
74054259|NCT02041533|147659946|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.95|1.43|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.43|0.95|
74054260|NCT02041533|147659947|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.20|0.79|
74054261|NCT02041533|147659948|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.86|1.24|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.24|0.86|
74054262|NCT02041533|147659949|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.46|1.06|||||Stratified by histology (squamous vs.non-squamous) at randomization. Strata adjusted odds ratio (Nivolumab over investigator choice of chemotherapy) using Mantel-Haenszel method.|||1.06|0.46|
74054263|NCT02500706|147659967|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|-0.02|||<|0.001|TWO_SIDED|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.07|-0.11|<0.001
74054264|NCT02500706|147659967|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of postmeal faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|0.1|||<|0.001|TWO_SIDED|95.0|0.004|0.19||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.19|0.004|<0.001
74054265|NCT02500706|147659967|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0%-points."|Treatment difference|-0.02||||0.633|TWO_SIDED|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.07|-0.11|0.633
74100127|NCT01371747|147749307|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.5|100.0|||||2-sided 95% exact binomial CI|||100|94.5|
74100128|NCT01371747|147749307|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|98.4|||||TWO_SIDED|95.0|91.6|100.0|||||2-sided 95% exact binomial CI|||100|91.6|
74100129|NCT01371747|147749307|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|91.7|||||TWO_SIDED|95.0|73.0|99.0|||||2-sided 95% exact binomial CI|||99|73|
74054266|NCT02500706|147659968|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: 1-hour postprandial glucose (PPG) increments superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog.~Superiority was confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0."|Treatment difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.36|-0.45||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA|||Change from baseline in postprandial glucose increment (meal test) is analysed using an analysis of variance model. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline postprandial glucose increment as a covariate.||-0.45|-1.36|<0.001
74054267|NCT02500706|147659969|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: 1,5-anhydroglucitol superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the lower boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was above 0."|Treatment difference|0.02||||0.924|TWO_SIDED|95.0|-0.31|0.34||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||Change from baseline in 1,5-anhydroglucitol was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline 1,5-anhydroglucitol as a covariate.||0.34|-0.31|0.924
74054268|NCT01497899|147660016|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the E/C/F/TAF group was at least 12% lower than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24. The alternative hypothesis was that the E/C/F/TAF group was less than 12% lower than the E/C/F/TDF group.|Difference in percentages|-2.9||||0.58|TWO_SIDED|95.0|-13.5|7.7|||Cochran-Mantel-Haenszel|P-value comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum.|Difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|||7.7|-13.5|0.58
74054269|NCT01680835|147660021|OTHER|Freedom from primary safety composite event at 36 months compared to a performance goal of 35%|Kaplan Meier|0.771|||<|0.001|ONE_SIDED|97.5|0.678||||Log Rank||||||0.678|<0.001
74054270|NCT01680835|147660022|OTHER|No hypothesis Testing for this endpoint.|Kaplan Meier|1.0|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|||||||||Stent Fracture at 1 Year||||
74054271|NCT01680835|147660022|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.989|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|||||||||Stent Fracture at 2 Years||||
74054272|NCT01680835|147660022|OTHER|No hypothesis testing was done for this endpoint|Kaplan Meier|0.965|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|||||||||Stent Fracture at 3 Years||||
74054273|NCT01680835|147660023|OTHER|No hypothesis testing was done at this endpoint|Kaplan Meier|0.86|STANDARD_ERROR_OF_MEAN|0.034|||TWO_SIDED|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 1 year||||
74054274|NCT01680835|147660023|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.782|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 2 years||||
74054275|NCT01680835|147660024|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.99|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|||||||||Estimate from freedom from major amputation through 3 years.||||
74054276|NCT01680835|147660025|OTHER||Kaplan Meier|0.781|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|||||||||Freedom from clinically-driven TLR through 3 Years||||
74054277|NCT02347124|147660034|SUPERIORITY||Odds Ratio (OR)|1.29||||0.13|TWO_SIDED|95.0|0.93|1.78||Adjusted for baseline sex, age, cigarettes per day, depression history, motivation, self-efficacy, current use of a stop-smoking medication, state quitline, and dental insurance.|Regression, Logistic|||||1.78|0.93|0.13
74054278|NCT02347124|147660035|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9|TWO_SIDED|95.0|0.69|1.53||Adjusted for baseline sex, age, depression history, motivation, self-efficacy, state quitline, and dental insurance.|Regression, Logistic|||||1.53|0.69|0.90
74054279|NCT02347124|147660036|SUPERIORITY||Odds Ratio (OR)|1.22||||0.21|TWO_SIDED|95.0|0.89|1.69||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||1.69|0.89|0.21
74054280|NCT02347124|147660037|SUPERIORITY||Odds Ratio (OR)|1.42||||0.04|TWO_SIDED|95.0|1.01|2.0||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||2.00|1.01|0.04
74054281|NCT02347124|147660038|SUPERIORITY||Odds Ratio (OR)|1.37||||0.09|TWO_SIDED|95.0|0.95|1.96||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||1.96|0.95|0.09
74054282|NCT02347124|147660039|SUPERIORITY||Odds Ratio (OR)|-0.05||||0.85|TWO_SIDED|95.0|-0.57|0.47|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.||||0.47|-0.57|0.85
74054283|NCT02347124|147660040|SUPERIORITY||Odds Ratio (OR)|0.41||||0.14|TWO_SIDED|95.0|-0.14|0.96|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.||||0.96|-0.14|0.14
74054284|NCT02347124|147660041|SUPERIORITY||Odds Ratio (OR)|0.35||||0.002|TWO_SIDED|95.0|0.13|0.56|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline self-efficacy score.||||0.56|0.13|.002
74054285|NCT02347124|147660042|SUPERIORITY||Odds Ratio (OR)|0.0||||0.97|TWO_SIDED|95.0|-0.22|0.23||Adjusted for sex, age, state quit line, and baseline self-efficacy score.|Regression, Linear|||||0.23|-0.22|0.97
74054286|NCT02347124|147660043|SUPERIORITY||Odds Ratio (OR)|-0.1||||0.16|TWO_SIDED|95.0|-0.24|0.04|||Regression, Linear|Adjusted for sex, age, state quit line, use of stop-smoking medications, baseline motivation, and baseline cigarettes per day.||||0.04|-0.24|0.16
74100130|NCT01371747|147749307|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.8|||||TWO_SIDED|95.0|78.9|99.9|||||2-sided 95% exact binomial CI|||99.9|78.9|
74100131|NCT01371747|147749307|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.5|||||TWO_SIDED|95.0|77.2|99.9|||||2-sided 95% exact binomial CI|||99.9|77.2|
74054287|NCT02347124|147660044|SUPERIORITY||Odds Ratio (OR)|-0.02||||0.83|TWO_SIDED|95.0|-0.16|0.13|||Regression, Linear|Adjusted for sex, age, state quit line, use of a smoking cessation medication at baseline, baseline motivation score, and baseline cigarettes per day.||||0.13|-0.16|0.83
74054288|NCT02347124|147660045|SUPERIORITY||Odds Ratio (OR)|0.22||||0.02|TWO_SIDED|95.0|0.04|0.41|||Regression, Linear|adjusted for sex, age, state quit line, and baseline motivation score.||||0.41|0.04|0.02
74054289|NCT02347124|147660046|SUPERIORITY||Odds Ratio (OR)|0.02||||0.82|TWO_SIDED|95.0|-0.17|0.21|||Regression, Linear|||||0.21|-0.17|0.82
74019512|NCT00927368|147591413|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.57|0.33||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.||0.33|-0.57|< 0.001
74019513|NCT00927368|147591413|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean catheter is greater than 0.5 points).|Mean Difference (Final Values)|0.12||||0.02|TWO_SIDED|95.0|-0.33|0.57||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.||0.57|-0.33|0.02
74019514|NCT00927368|147591413|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.72|0.16||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.||0.16|-0.72|< 0.001
74019515|NCT00927368|147591413|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.28||||0.11|TWO_SIDED|95.0|-0.16|0.72||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.||0.72|-0.16|0.11
74019516|NCT00927368|147591414|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|5.0||||0.04|TWO_SIDED|95.0|-17.0|34.0||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.||34|-17|0.04
74019517|NCT00927368|147591414|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-5.0||||0.002|TWO_SIDED|95.0|-25.0|21.0||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.||21|-25|0.002
74019518|NCT00927368|147591414|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|3.0||||0.03|TWO_SIDED|95.0|-25.0|21.0||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.||21|-25|0.03
74019519|NCT00927368|147591414|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-3.0||||0.005|TWO_SIDED|95.0|-24.0|23.0||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.||23|-24|0.005
74019520|NCT00927368|147591414|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-2.0||||0.006|TWO_SIDED|95.0|-22.0|25.0||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.||25|-22|0.006
74054290|NCT02347124|147660047|SUPERIORITY||Odds Ratio (OR)|-0.02||||0.8|TWO_SIDED|95.0|-0.2|0.16|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medications.||||0.16|-0.20|0.80
74054291|NCT02347124|147660048|SUPERIORITY||Odds Ratio (OR)|0.07||||0.45|TWO_SIDED|95.0|-0.11|0.26|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medication.||||0.26|-0.11|0.45
74054292|NCT03524664|147660055|SUPERIORITY|||||||0.523||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71) = 0.411, p =.523||Repeated measures ANOVA||||.523
74054293|NCT03524664|147660056|SUPERIORITY|||||||0.173||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=1.89, p=.173||Repeated measures ANOVA||||.173
74054294|NCT03524664|147660057|SUPERIORITY|||||||0.14||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.23, p=.140||Outcome data analyzed for those with complete data at both timepoints.||||.140
74054295|NCT03524664|147660058|SUPERIORITY|||||||0.845||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=.039, p=0.845||Outcome data analyzed for those with complete data at both timepoints.||||0.845
74054296|NCT03524664|147660059|SUPERIORITY|||||||0.147||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=2.147, p=.147||Outcome data analyzed for those with complete data at both timepoints.||||.147
74054297|NCT03524664|147660060|SUPERIORITY|||||||0.429||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=.633, p=.429||Outcome data analyzed for those with complete data at both timepoints.||||.429
74054298|NCT03524664|147660061|SUPERIORITY|||||||0.208||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=1.618, p=.208||Outcome data analyzed for those with complete data at both timepoints.||||.208
74054299|NCT03524664|147660062|SUPERIORITY|||||||0.3||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=1.09, p=.300||Outcome data analyzed for those with complete data at both timepoints.||||.300
74054300|NCT03524664|147660063|SUPERIORITY|||||||0.099||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.79, p=.099||Outcome data analyzed for those with complete data at both timepoints.||||.099
74054301|NCT03524664|147660064|SUPERIORITY|||||||0.105||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.70, p=.105||Outcome data analyzed for those with complete data at both timepoints.||||.105
74054302|NCT03524664|147660065|SUPERIORITY|||||||0.699||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.15, p=.699||Repeated measures ANOVA||||.699
74054303|NCT03524664|147660066|SUPERIORITY|||||||0.945||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.005, p=.945||Repeated measures ANOVA||||.945
74054304|NCT03524664|147660067|SUPERIORITY|||||||0.767||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.088, p=.767||Repeated measures ANOVA||||.767
74054305|NCT03524664|147660068|SUPERIORITY|||||||0.682||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=.0.17, p=.682||Repeated measures ANOVA||||.682
74054306|NCT03524664|147660069|SUPERIORITY|||||||0.96||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,42)=0.003, p=.960||Repeated measures ANOVA||||.960
74054307|NCT03524664|147660070|SUPERIORITY|||||||0.643||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,42)=0.218, p=.643||Repeated measures ANOVA||||.643
74054308|NCT03524664|147660071|SUPERIORITY|||||||0.118||||||The threshold for statistical significance was p = 0.05.|ANOVA|Time X Group F(2,90)=2.19, p.118||Repeated measures ANOVA||||.118
74054309|NCT03524664|147660072|SUPERIORITY|||||||0.8||||||The threshold for statistical significance was p = 0.05.|ANOVA|Time x Group F(2,90)=.223, p=.800||Repeated measures ANOVA||||.800
74054310|NCT03524664|147660073|SUPERIORITY|||||||0.863||||||The threshold for statistical significance was p = 0.05.|ANOVA|Group x Time F(2,92)=0.148, p=.863||Repeated measures ANOVA||||.863
74054311|NCT01522391|147660080|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||||0.491|0.004|0.012
74054312|NCT01522391|147660081|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||||0.491|0.004|0.012
74054313|NCT01522391|147660082|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7||2.66|0.022|0.242
74054314|NCT01522391|147660082|OTHER||Ratio between geometric means|0.428||||0.482|TWO_SIDED|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21||4.696|0.039|0.482
74054315|NCT01522391|147660083|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7||2.660|0.022|0.242
74054316|NCT01522391|147660083|OTHER||Ratio between geometric means|0.428||||0.482|TWO_SIDED|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21||4.696|0.039|0.482
74054317|NCT01522391|147660084|OTHER||Ratio between geometric means|0.288||||0.395|TWO_SIDED|95.0|0.016|5.221|||Mixed Models Analysis|||Day 7||5.221|0.016|0.395
74054318|NCT01522391|147660084|OTHER||Ratio between geometric means|0.067||||0.067|TWO_SIDED|95.0|0.004|1.218|||Mixed Models Analysis|||Day 14||1.218|0.004|0.067
74054319|NCT01522391|147660084|OTHER||Ratio between geometric means|0.484||||0.62|TWO_SIDED|95.0|0.027|8.787|||Mixed Models Analysis|||Day 21||8.787|0.027|0.620
74054320|NCT01522391|147660085|OTHER||Ratio between geometric means|0.287||||0.403|TWO_SIDED|95.0|0.015|5.55|||Mixed Models Analysis|||Day 7||5.550|0.015|0.403
74054321|NCT01522391|147660085|OTHER||Ratio between geometric means|0.032||||0.021|TWO_SIDED|95.0|0.002|0.583|||Mixed Models Analysis|||Day 14||0.583|0.002|0.021
74054322|NCT01522391|147660085|OTHER||Ratio between geometric means|0.271||||0.368|TWO_SIDED|95.0|0.015|4.779|||Mixed Models Analysis|||Day 21||4.779|0.015|0.368
74054323|NCT01522391|147660086|OTHER||Ratio between geometric means|1.045||||0.97|TWO_SIDED|95.0|0.106|10.32|||Mixed Models Analysis|||Day 7||10.32|0.106|0.970
74054324|NCT01522391|147660086|OTHER||Ratio between geometric means|0.045||||0.009|TWO_SIDED|95.0|0.005|0.447|||Mixed Models Analysis|||Day 14||0.447|0.005|0.009
74054325|NCT01522391|147660086|OTHER||Ratio between geometric means|0.36||||0.377|TWO_SIDED|95.0|0.036|3.556|||Mixed Models Analysis|||Day 21||3.556|0.036|0.377
74054326|NCT01522391|147660087|OTHER||Ratio between geometric means|0.961||||0.974|TWO_SIDED|95.0|0.081|11.43|||Mixed Models Analysis|||Day 7||11.43|0.081|0.974
74054327|NCT01522391|147660087|OTHER||Ratio between geometric means|0.046||||0.013|TWO_SIDED|95.0|0.004|0.512|||Mixed Models Analysis|||Day 14||0.512|0.004|0.013
74054328|NCT01522391|147660087|OTHER||Ratio between geometric means|0.447||||0.504|TWO_SIDED|95.0|0.041|4.883|||Mixed Models Analysis|||Day 21||4.883|0.041|0.504
74054329|NCT01522391|147660088|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.659|||Mixed Models Analysis|||Day 7||2.659|0.022|0.242
74054330|NCT01522391|147660088|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||Day 14||0.491|0.004|0.012
74054331|NCT01522391|147660088|OTHER||Ratio between geometric means|0.428||||0.483|TWO_SIDED|95.0|0.039|4.697|||Mixed Models Analysis|||Day 21||4.697|0.039|0.483
74054332|NCT01522391|147660089|OTHER||Ratio between geometric means|0.202||||0.197|TWO_SIDED|95.0|0.017|2.34|||Mixed Models Analysis|||Day 7||2.340|0.017|0.197
74054333|NCT01522391|147660089|OTHER||Ratio between geometric means|0.021||||0.002|TWO_SIDED|95.0|0.002|0.227|||Mixed Models Analysis|||Day 14||0.227|0.002|0.002
74054334|NCT01522391|147660089|OTHER||Ratio between geometric means|0.257||||0.257|TWO_SIDED|95.0|0.024|2.752|||Mixed Models Analysis|||Day 21||2.752|0.024|0.257
74054335|NCT01522391|147660090|OTHER||Least Square Mean Difference|20.38||||0.346|TWO_SIDED|95.0|-22.42|63.19|||Mixed Models Analysis|||Day 7||63.19|-22.42|0.346
74054336|NCT01522391|147660090|OTHER||Least Square Mean Difference|29.1||||0.18|TWO_SIDED|95.0|-13.71|71.9|||Mixed Models Analysis|||Day 14||71.90|-13.71|0.18
74054337|NCT01522391|147660090|OTHER||Least Square Mean Difference|-11.64||||0.59|TWO_SIDED|95.0|-54.44|31.16|||Mixed Models Analysis|||Day 21||31.16|-54.44|0.590
74054338|NCT01522391|147660091|OTHER||Least Square Mean Difference|5.95||||0.748|TWO_SIDED|95.0|-30.84|42.73|||Mixed Models Analysis|||Day 7||42.73|-30.84|0.748
74054339|NCT01522391|147660091|OTHER||Least Square Mean Difference|14.62||||0.437|TWO_SIDED|95.0|-22.65|51.88|||Mixed Models Analysis|||Day 14||51.88|-22.65|0.437
74054340|NCT01522391|147660091|OTHER||Least Square Mean Difference|-18.66||||0.322|TWO_SIDED|95.0|-55.92|18.61|||Mixed Models Analysis|||Day 21||18.61|-55.92|0.322
74054341|NCT01522391|147660092|OTHER||Least Square Mean Difference|8.04||||0.631|TWO_SIDED|95.0|-25.15|41.24|||Mixed Models Analysis|||Day 7||41.24|-25.15|0.631
74054342|NCT01522391|147660092|OTHER||Least Square Mean Difference|20.44||||0.224|TWO_SIDED|95.0|-12.75|53.63|||Mixed Models Analysis|||Day 14||53.63|-12.75|0.224
74054343|NCT01522391|147660092|OTHER||Least Square Mean Difference|-1.23||||0.941|TWO_SIDED|95.0|-34.42|31.96|||Mixed Models Analysis|||Day 21||31.96|-34.42|0.941
74054344|NCT01522391|147660093|OTHER||Least Square Means Difference|0.97||||0.954|TWO_SIDED|95.0|-32.93|34.87|||Mixed Models Analysis|||Day 7||34.87|-32.93|0.954
74054345|NCT01522391|147660093|OTHER||Least Square Mean Difference|15.72||||0.358|TWO_SIDED|95.0|-18.18|49.62|||Mixed Models Analysis|||Day 14||49.62|-18.18|0.358
74054346|NCT01522391|147660093|OTHER||least Square Mean Difference|-7.94||||0.642|TWO_SIDED|95.0|-41.82|25.94|||Mixed Models Analysis|||Day 21||25.94|-41.82|0.642
74054347|NCT01522391|147660094|OTHER|||||||0.701|||||||Cochran-Mantel-Haenszel|||Day 7||||0.701
74054348|NCT01522391|147660094|OTHER|||||||0.898|||||||Cochran-Mantel-Haenszel|||Day 14||||0.898
74054349|NCT01522391|147660094|OTHER|||||||0.271|||||||Cochran-Mantel-Haenszel|||Day 21||||0.271
74054350|NCT01522391|147660095|OTHER|||||||0.511|||||||Cochran-Mantel-Haenszel|||Day 7||||0.511
74054351|NCT01522391|147660095|OTHER|||||||0.777|||||||Cochran-Mantel-Haenszel|||Day 14||||0.777
74054352|NCT01522391|147660095|OTHER|||||||0.204|||||||Cochran-Mantel-Haenszel|||Day 21||||0.204
74054353|NCT01522391|147660096|OTHER|||||||0.489|||||||Cochran-Mantel-Haenszel|||Day 7||||0.489
74054354|NCT01522391|147660096|OTHER|||||||0.249|||||||Cochran-Mantel-Haenszel|||Day 14||||0.249
74054355|NCT01522391|147660096|OTHER|||||||0.098|||||||Cochran-Mantel-Haenszel|||Day 21||||0.098
74054356|NCT01522391|147660097|OTHER|||||||0.291|||||||Cochran-Mantel-Haenszel|||Day 7||||0.291
74054357|NCT01522391|147660097|OTHER|||||||0.113|||||||Cochran-Mantel-Haenszel|||Day 14||||0.113
74054358|NCT01522391|147660097|OTHER|||||||0.033|||||||Cochran-Mantel-Haenszel|||Day 21||||0.033
74054359|NCT01522391|147660098|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7||||0.825
74054360|NCT01522391|147660098|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 14||||0.825
74054361|NCT01522391|147660098|OTHER|||||||0.208|||||||Cochran-Mantel-Haenszel|||||||0.208
74054362|NCT01522391|147660099|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7||||0.825
74054363|NCT01522391|147660099|OTHER|||||||0.82|||||||Cochran-Mantel-Haenszel|||Day 14||||0.820
74054364|NCT01522391|147660099|OTHER|||||||0.086|||||||Cochran-Mantel-Haenszel|||Day 21||||0.086
74054365|NCT01522391|147660100|OTHER|||||||0.378|||||||Cochran-Mantel-Haenszel|||Day 7||||0.378
74054366|NCT01522391|147660100|OTHER|||||||0.975|||||||Cochran-Mantel-Haenszel|||Day 14||||0.975
74054367|NCT01522391|147660100|OTHER|||||||0.962|||||||Cochran-Mantel-Haenszel|||Day 21||||0.962
74054368|NCT01522391|147660101|OTHER|||||||0.375|||||||Cochran-Mantel-Haenszel|||Day 7||||0.375
74054369|NCT01522391|147660101|OTHER|||||||0.946|||||||Cochran-Mantel-Haenszel|||Day 14||||0.946
74054370|NCT01522391|147660101|OTHER|||||||0.495|||||||Cochran-Mantel-Haenszel|||Day 21||||0.495
74054371|NCT01522391|147660104|OTHER|||||||0.477|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning||||0.477
74054372|NCT01522391|147660104|OTHER|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||Day 14 morning||||0.651
74054373|NCT01522391|147660104|OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Day 21 morning||||0.340
74054374|NCT01522391|147660105|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning||||0.300
74054375|NCT01522391|147660105|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.705
74054376|NCT01522391|147660105|OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Day 21||||0.286
74054377|NCT01140646|147660190|SUPERIORITY_OR_OTHER|||||||0.0903||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash score is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.||||0.0903
74054378|NCT01140646|147660190|SUPERIORITY_OR_OTHER|||||||0.1553||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash frequency is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.||||0.1553
74054379|NCT03006276|147660195|SUPERIORITY||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.36|2.94|||Fisher Exact|||Last Observation Carried Forward (LOCF)||2.94|1.36|<0.001
74054380|NCT03006276|147660195|SUPERIORITY||Odds Ratio (OR)|1.97|||<|0.001|TWO_SIDED|95.0|1.34|2.89|||Fisher Exact|||||2.89|1.34|<0.001
74054381|NCT03006276|147660196|SUPERIORITY||Odds Ratio (OR)|1.68||||0.007|TWO_SIDED|95.0|1.17|2.43|||Fisher Exact|||last observation carried forward (LOCF)||2.43|1.17|0.007
74054382|NCT03006276|147660196|SUPERIORITY||Odds Ratio (OR)|1.69||||0.007|TWO_SIDED|95.0|1.16|2.44|||Fisher Exact|||observed cases (OC)||2.44|1.16|0.007
74054383|NCT03245372|147660222|SUPERIORITY|||||||0.114|||||||Wilcoxon (Mann-Whitney)|||||||0.114
74054384|NCT03245372|147660223|SUPERIORITY|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||||||0.692
74054385|NCT03245372|147660224|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||0.082
74054386|NCT03245372|147660225|SUPERIORITY|||||||0.443|||||||Wilcoxon (Mann-Whitney)|||||||0.443
74054387|NCT03245372|147660226|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||||||0.668
74054388|NCT03245372|147660227|SUPERIORITY|||||||0.516|||||||Chi-squared|||||||0.516
74054389|NCT03245372|147660229|SUPERIORITY|||||||0.229|||||||Wilcoxon (Mann-Whitney)|||||||0.229
74054390|NCT03245372|147660230|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
74054391|NCT00842829|147660231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper limit of the 90% CI was \<8%.|Mean Difference (Net)|-6.3|||||ONE_SIDED|95.0||1.4|||||The upper bound of the 2-sided 90% confidence interval is equivalent to the upper bound of the 1-sided 95% confidence interval.|Treatment comparison difference (100 mcg - 200 mcg)||1.4||
74054392|NCT04047342|147660255|SUPERIORITY||Odds Ratio (OR)|0.97||||0.828|TWO_SIDED|95.0|0.72|1.3||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.30|0.72|.828
74054393|NCT00660829|147660259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5633|STANDARD_DEVIATION|0.3345|<|0.001||95.0|-2.22|-0.91|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.91|-2.22|<0.001
74054394|NCT00660829|147660260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7444|STANDARD_ERROR_OF_MEAN|0.1677|<|0.001||95.0|-1.07|-0.42|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.42|-1.07|<0.001
74054395|NCT00660829|147660261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4403|STANDARD_DEVIATION|0.3406|<|0.001||95.0|-2.11|-0.77|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.77|-2.11|<0.001
74100132|NCT01371747|147749308|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.2|||||TWO_SIDED|95.0|86.7|99.0|||||2-sided 95% exact binomial CI|||99.0|86.7|
74054396|NCT00660829|147660262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2907|STANDARD_DEVIATION|0.3204|<|0.001||95.0|-1.92|0.66|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline||0.66|-1.92|<0.001
74054397|NCT00660829|147660263|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|||Change from baseline||||0.001
74054398|NCT02127931|147660266|OTHER|||||||0.005|||||||Correlation|||ADHD-I||||0.005
74054399|NCT02127931|147660266|OTHER|||||||0.023|||||||Correlation|||ADHD-C||||0.023
74054400|NCT02127931|147660267|OTHER|||||||0.013|||||||Correlation|||||||0.013
74054401|NCT02058940|147660300|OTHER|||||||0.2|||||||Spearman's Correlation Coefficient|||||||0.2
74054402|NCT01519700|147660305|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limit: -1 day Power: 90% Confidence level: 97.5% Randomization ratio: 1:1 (EP2006:Neupogen)|Mean Difference (Net)|0.04|||||ONE_SIDED|97.5|-0.26||||||The one-sided 97.5% Confidence Interval: \[-0.26, ∞).||||-0.26|
74054403|NCT04120116|147660312|SUPERIORITY||Odds Ratio (OR)|0.3||||0.068|TWO_SIDED|95.0|0.11|1.08||P value for statistical significance is \<0.05|Mixed Models Analysis|||||1.08|0.11|0.068
74054404|NCT04120116|147660314|SUPERIORITY||Least squares mean difference|1.25|STANDARD_ERROR_OF_MEAN|2.611||0.634|TWO_SIDED|95.0|-3.945|6.439||P value for statistical significance is \<0.05|Mixed Models Analysis|||||6.439|-3.945|0.634
74054405|NCT04250558|147660321|OTHER|||||||0.05|||||||Regression, Logistic|||Kinetic parameters were assessed by Mann-Whitney U test in MATLAB Statistics and Machine Learning Toolbox. Receiver operating characteristic (ROC) analysis based on logistic regression was utilized, with one surgical condition versus the other two states as the binary dependent variable, and each perfusion-related kinetic parameter of Imax, IS and BF as the independent variable. Power analysis was performed to evaluate the statistical validity, using G\*Power software||||0.05
74054406|NCT00772031|147660324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.97||0.77|TWO_SIDED|95.0|-1.8|2.4|||ANCOVA|covariate adjustments: study site, baseline mod-to-sev 28-day headache-rate, topiramate use, medication overuse, and anti-depressive medications use.|Topiramate plus placebo mean reduction minus topiramate plus propranolol reduction|The study was designed to enroll 250 subjects to provide at least 90% power to detect a 3-day difference and 87% power to detect a 2.5-day difference in 28-day moderate-to-severe headache rate reductions at six months, assuming a type I error rate of 0.05, a two-sided test, a 10% loss to follow-up and a standard deviation of within-person change in days with headache of six.||2.4|-1.8|0.77
74054407|NCT00772031|147660325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0|0.75|2.78||||||||2.78|0.75|
74054408|NCT00772031|147660326|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.5|2.02||||||||2.02|0.50|
74054409|NCT00772031|147660328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_DEVIATION|3.75||0.91||95.0|||||ANCOVA|||||||0.91
74054410|NCT00656136|147660332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.077||||0.7428|TWO_SIDED|95.0|0.862|1.346||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Primary analysis was performed after 358 deaths were observed among randomized patients. The data cut-off date for the primary analysis was 08 July 2010.||1.346|0.862|0.7428
74054411|NCT00656136|147660332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.976||||0.3955|TWO_SIDED|95.0|0.814|1.17||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Final analysis was performed after 526 deaths were observed among randomized patients. The data cut-off date for the final analysis was 04 October 2013.||1.170|0.814|0.3955
74100133|NCT01371747|147749308|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.8|||||TWO_SIDED|95.0|81.0|96.5|||||2-sided 95% exact binomial CI|||96.5|81.0|
74100134|NCT01371747|147749308|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|81.3|||||TWO_SIDED|95.0|69.5|89.9|||||2-sided 95% exact binomial CI|||89.9|69.5|
74054412|NCT00656136|147660333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.381|||<|0.0001|TWO_SIDED|95.0|0.306|0.475||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||||0.475|0.306|<0.0001
74054413|NCT00656136|147660334|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.61||||0.0071|TWO_SIDED|95.0|2.1|115.0||P-value is derived from logistic regression model adjusted for stratification factors, gender and baseline ECOG score (0, 1 vs 2)|Regression, Logistic|Model stratified by gender and baseline ECOG score (0,1 vs 2)||||115|2.1|0.0071
74054414|NCT02087085|147660335|SUPERIORITY||Least Squares Mean Difference|-0.3589|STANDARD_ERROR_OF_MEAN|0.1804||0.047|TWO_SIDED|95.0|-0.7132|-0.0047||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||-0.0047|-0.7132|0.047
74054415|NCT02087085|147660336|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.4||0.39|TWO_SIDED|95.0|-3.9|1.5||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||1.5|-3.9|0.390
74054416|NCT02087085|147660337|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.4||0.301|TWO_SIDED|95.0|-4.2|1.3||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||1.3|-4.2|0.301
74054417|NCT03382639|147660375|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.66||0.426|TWO_SIDED|95.0|-1.4|1.2|||Mixed Models Analysis|||||1.2|-1.4|0.426
74054418|NCT03382639|147660375|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.66||0.725|TWO_SIDED|95.0|-1.5|1.1|||Mixed Models Analysis|||||1.1|-1.5|0.725
74054419|NCT03382639|147660375|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.68||0.808|TWO_SIDED|95.0|-0.7|1.9|||Mixed Models Analysis|||||1.9|-0.7|0.808
74054420|NCT00218439|147660408|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
74054421|NCT00218439|147660409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
74054422|NCT00218439|147660410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
74054423|NCT00218439|147660411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|||||||Mixed Models Analysis|||||||0.33
74054424|NCT00218439|147660412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
74054425|NCT01474291|147660425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.023|TWO_SIDED|95.0|1.06|2.3|||Wald Chi-square|Wald Chi-square Test for Type 3 generalized estimating equation (GEE) Analysis.||"Influence of baseline factor Patient's Age (\>=65) upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||2.30|1.06|0.0230
74054426|NCT01474291|147660425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.92|8.43|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor No methotrexate (MTX) sequences within the two last years upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||8.43|3.92|<0.0001
74054427|NCT01474291|147660425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.0212|TWO_SIDED|95.0|1.11|3.7|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Past history of severe infectious disease upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||3.70|1.11|0.0212
74054428|NCT01474291|147660425|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0076|TWO_SIDED|95.0|1.05|1.41|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Higher Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) (unit=1) on physician decision to initiate tocilizumab monotherapy; DAS28-ESR was calculated from the number of swollen joints and tender joints using 28-joint count, ESR (millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity; scores range from 0 to 10; higher scores correspond to greater disease activity (multivariate analysis)."||1.41|1.05|0.0076
74054429|NCT02790476|147660456|SUPERIORITY||Mean Difference (Final Values)|-27.8|||<|0.05|TWO_SIDED|95.0|-38.2|-17.63||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (288.36-347.65 = -59.29) and control (318.60-350.09 = -31.49) arms, resulting in a difference of -27.80.|1-3 months post intervention||-17.63|-38.20|<0.05
74054430|NCT02790476|147660456|SUPERIORITY||Mean Difference (Final Values)|-12.42|||<|0.01|TWO_SIDED|95.0|-18.4|-6.55||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (167.83-347.65 = -179.83) and control (182.67-350.09 = -167.41) arms, resulting in a difference of -12.42.|||-6.55|-18.40|<0.01
74054431|NCT02790476|147660457|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.224|TWO_SIDED|95.0|-0.92|0.22||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (3.45-3.74 = -0.29) and control (3.45-4.59= -0.64) arms, resulting in a difference of -0.35.|Change in mean number of =\> 50 MME prescriptions pre- to 1-3 months post-intervention||0.22|-0.92|0.224
74054432|NCT02790476|147660457|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.08|-0.33||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (3.00-3.74 = -0.74) and control (3.15-4.59= -1.44) arms, resulting in a difference of -0.70.|Change in mean number of =\> 50 MME prescriptions pre- to 4-12 months post-intervention||-0.33|-1.08|<0.001
74100135|NCT01371747|147749308|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|79.2|||||TWO_SIDED|95.0|57.8|92.9|||||2-sided 95% exact binomial CI|||92.9|57.8|
74100136|NCT01371747|147749308|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|91.7|||||TWO_SIDED|95.0|73.0|99.0|||||2-sided 95% exact binomial CI|||99|73|
74100137|NCT01371747|147749308|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|77.3|||||TWO_SIDED|95.0|54.6|92.2|||||2-sided 95% exact binomial CI|||92.2|54.6|
74100138|NCT01371747|147749310|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|86.3|||||TWO_SIDED|95.0|73.7|94.3|||||2-sided 95% exact binomial CI|||94.3|73.7|
74054433|NCT02790476|147660457|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.279|TWO_SIDED|95.0|-0.59|0.17||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.00-2.14 = -0.14) and control (2.20-2.55= -0.35) arms, resulting in a difference of -0.21.|Change in mean number of \> 90 MME prescriptions pre- to 1-3 months post-intervention||0.17|-0.59|0.279
74054434|NCT02790476|147660457|SUPERIORITY||Mean Difference (Final Values)|-0.38|||<|0.01|TWO_SIDED|95.0|-0.63|-0.12||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (1.71-2.14 = -0.43) and control (1.74-2.55= -0.81) arms, resulting in a difference of -0.38.|Change in mean number of \> 90 MME prescriptions pre- to 4-12 months post-intervention||-0.12|-0.63|<0.01
74054435|NCT02790476|147660458|SUPERIORITY||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-3.2|-0.1||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|Pre-intervention values were trimmed at 95% with bootstrapped means and confidence intervals.|This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean DME in the letter (72.3-76 = -3.7) and control (82-82.9 = -0.9) arms, resulting in a difference of -1.6.|||-0.1|-3.2|<0.05
74054436|NCT02790476|147660460|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.823|TWO_SIDED|95.0|-0.23|0.29||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.44-3.72 = -1.28) and control (2.26-3.51= -1.25) arms, resulting in a difference of 0.03.|Change in mean number of new patients pre- to 1-3 months post-intervention||0.29|-0.23|0.823
74054437|NCT02790476|147660460|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.692|TWO_SIDED|95.0|-0.2|0.14||The threshold for statistical significance is p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.08-3.72 = -1.64) and control (1.84-3.51= -1.67) arms, resulting in a difference of -0.03.|Change in mean number of new patients pre- to 4-12 months post-intervention||0.14|-0.20|0.692
74054438|NCT00679354|147660523|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.0||||1|TWO_SIDED||||||Spearman's Correlation|||||||1.000
74054439|NCT00679354|147660524|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.56||||0.057|TWO_SIDED||||||Spearman's Correlation|||||||0.057
74054440|NCT00679354|147660525|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.22||||0.495|TWO_SIDED||||||Spearman's Correlation|||||||0.495
74054441|NCT00679354|147660526|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.48||||0.114|TWO_SIDED||||||Spearman's Correlation|||||||0.114
74054442|NCT02898662|147660533|OTHER|The null hypothesis was that during the 52-week double-blind treatment period, the time to LOAC in the AZD1419 arm was equal to the corresponding time to LOAC in the placebo arm.|Hazard Ratio (HR)|1.05||||0.5722|TWO_SIDED|95.0|0.59|1.87||1-sided p-value|Regression, Cox||Hazard ratio \< 1 favours AZD1419 over placebo.|Comparison between groups for time to LOAC. Cox regression model analysis with age and gender included as covariates.||1.87|0.59|0.5722
74054443|NCT02898662|147660534|OTHER||Odds Ratio (OR)|1.86||||0.2006|TWO_SIDED|95.0|0.72|4.79||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants experiencing LOAC. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment, visit and age and gender as covariates.||4.79|0.72|0.2006
74054444|NCT02898662|147660535|OTHER||LS Mean difference|-0.02||||0.8166|TWO_SIDED|95.0|-0.22|0.17||2-sided p-value|Repeated measures analysis|||Comparison between groups for ACQ-5 score. Repeated measures analysis.||0.17|-0.22|0.8166
74054445|NCT02898662|147660536|OTHER||LS Mean difference|-0.03||||0.8412|TWO_SIDED|95.0|-0.32|0.26||2-sided p-value|Repeated measures analysis|||Comparison between groups for asthma daily diary score. Repeated measures analysis.||0.26|-0.32|0.8412
74054446|NCT02898662|147660537|OTHER|The null hypothesis was that the time to moderate or severe exacerbation was not different between AZD1419 and placebo.|Hazard Ratio (HR)|0.8||||0.5477|TWO_SIDED|95.0|0.38|1.67||2-sided p-value|Regression, Cox||Hazard ratio \< 1 favours AZD1419 over placebo.|Comparison between groups for time to moderate or severe asthma exacerbation. Cox regression model analysis with age and gender included as covariates.||1.67|0.38|0.5477
74054447|NCT02898662|147660537|OTHER||Odds Ratio (OR)|0.88||||0.7294|TWO_SIDED|95.0|0.41|1.86||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants with moderate or severe asthma exacerbation. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment and visit as covariates.||1.86|0.41|0.7294
74054448|NCT02898662|147660539|OTHER||LS Mean difference|0.06||||0.3764|TWO_SIDED|95.0|-0.08|0.2||2-sided p-value|Repeated measures analysis|||Comparison between groups for pre-BD FEV1. Repeated measures analysis.||0.20|-0.08|0.3764
73888166|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|96.1||||0.1688|TWO_SIDED|95.0|-41.2|233.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||233.3|-41.2|0.1688
74054449|NCT02898662|147660539|OTHER||LS Mean difference|-0.03||||0.7013|TWO_SIDED|95.0|-0.17|0.11||2-sided p-value|Repeated measures analysis|||Comparison between groups for post-BD FEV1. Repeated measures analysis.||0.11|-0.17|0.7013
74054450|NCT02898662|147660540|OTHER||LS Mean difference|-0.32||||0.9686|TWO_SIDED|95.0|-16.54|15.9||2-sided p-value|Repeated measures analysis|||Comparison between groups for PEF. Repeated measures analysis.||15.90|-16.54|0.9686
74054451|NCT02898662|147660541|OTHER||LS Mean difference|-2.02||||0.5403|TWO_SIDED|95.0|-8.55|4.52||2-sided p-value|Repeated measures analysis|||Comparison between groups for FeNO. Repeated measures analysis.||4.52|-8.55|0.5403
74054452|NCT03802331|147660542|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R (%)|166.02|||||TWO_SIDED|90.0|143.17|192.53|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 19.0.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||192.53|143.17|
74054453|NCT03802331|147660543|OTHER|Relative bioavailability|Ajusted Geometric Mean Ratio T/R (%)|235.5|||||TWO_SIDED|90.0|179.82|308.42|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 35.4.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||308.42|179.82|
74054454|NCT03802331|147660544|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R (%)|159.39|||||TWO_SIDED|90.0|140.11|181.34|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 16.5.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||181.34|140.11|
74054455|NCT00851721|147660589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Two-sample, two-sided t-test|||H0: μ(on-demand) = μ(prophylaxis) Versus H1: μ(on-demand) ≠ μ(prophylaxis) (Where H0 implies no difference in mean bleeding episode rate between prophylaxis and on-demand treatment arms and H1 implies otherwise. This test was performed at a significance level of 5%, two-sided, two sample)||||0.0003
74054456|NCT00851721|147660591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|||||||Two-sample, two-sided t-test|||Spontaneous Bleeds||||0.0008
74054457|NCT00851721|147660591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0199|||||||Two-sample, two-sided t-test|||Traumatic Bleeds||||0.0199
74054458|NCT00851721|147660591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Two-sample, two-sided t-test|||Joint Bleeds||||0.0006
74054459|NCT00851721|147660591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0227|||||||Two-sample, two-sided t-test|||Non-Joint Bleeds||||0.0227
74054460|NCT00851721|147660591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||Two-sample, two-sided t-test|||Spontaneous Joint Bleeds||||0.0013
74054461|NCT00851721|147660591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Two-sample, two-sided t-test|||Spontaneous Non-Joint Bleeds||||0.0030
74054462|NCT00851721|147660591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0254|||||||Two-sample, two-sided t-test|||Traumatic Joint Bleeds||||0.0254
74054463|NCT00851721|147660591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9322|||||||Two-sample, two-sided t-test|||Traumatic Non-Joint Bleeds||||0.9322
74054464|NCT00851721|147660593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0271|||||||Two-sample, two-sided t-test|||||||0.0271
74054465|NCT00851721|147660600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0067||95.0|||||Mann-Whitney tests (Wilcoxon-Rank Sum)|||||||0.0067
74054466|NCT03223649|147660632|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.035||0.005|TWO_SIDED|95.0|-0.17|-0.03||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||-.03|-.17|0.005
74054467|NCT03223649|147660633|SUPERIORITY||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.011||0.349|TWO_SIDED|95.0|-0.033|0.011||Unadjusted P-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||0.011|-.033|0.349
74054468|NCT03223649|147660634|SUPERIORITY||Mean Difference (Final Values)|-0.043|STANDARD_ERROR_OF_MEAN|0.021||0.045|TWO_SIDED|95.0|-0.084|-0.002||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||-.002|-.084|.045
74054469|NCT03223649|147660635|SUPERIORITY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.016||0.226|TWO_SIDED|95.0|-0.051|0.013||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||0.013|-0.051|0.226
74054470|NCT03223649|147660636|SUPERIORITY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|0.545|<|0.001|TWO_SIDED|95.0|-6.884|-4.716|||t-test, 2 sided|||||-4.716|-6.884|<0.001
74054471|NCT03223649|147660637|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.116||0.39|TWO_SIDED|95.0|-0.33|0.13|||t-test, 2 sided|||||0.130|-0.330|0.39
74054472|NCT03223649|147660638|SUPERIORITY||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.046||0.648|TWO_SIDED|95.0|-0.071|0.114|||ANCOVA|Dependent variable in Kcal log transformed, comparison adjusted for: age(y), lean mass(kg), fat mass(kg)||||0.114|-0.071|0.648
74054473|NCT03223649|147660639|SUPERIORITY||Mean Difference (Final Values)|0.834|STANDARD_ERROR_OF_MEAN|1.354||0.539|TWO_SIDED|95.0|-1.857|3.525|||ANCOVA|Adjusted for age (years)||||3.525|-1.857|0.539
74054474|NCT03223649|147660640|SUPERIORITY||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|1.766||0.55|TWO_SIDED|95.0|-4.57|2.45|||ANCOVA|Adjusted for age (years)||||2.45|-4.57|0.550
74054475|NCT03223649|147660641|SUPERIORITY||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.681||0.741|TWO_SIDED|95.0|-1.127|1.579|||ANCOVA|Adjusted for age (years)||||1.579|-1.127|0.741
74054476|NCT03982069|147660642|OTHER||||||<|0.001||||||All listed antigens|Chi-squared|||||||<0.001
74054477|NCT03982069|147660643|OTHER||||||<|0.001||||||All listed antigens|Chi-squared|||||||<0.001
74054478|NCT03982069|147660644|OTHER||||||<|0.001||||||Day 28 for all listed antigens|Chi-squared|||||||<0.001
74054479|NCT03982069|147660644|OTHER|||||||0.4||||||Day 0, A/H1N1-A/Brisbane|Chi-squared|||||||0.40
74054480|NCT03982069|147660644|OTHER|||||||0.36||||||Day 0 A/H1N1-A/Kansas egg grown virus|Chi-squared|||||||0.36
74054481|NCT03982069|147660644|OTHER|||||||0.08||||||Day 0 A/H1N1-A/Kansas cell grown virus|Chi-squared|||||||0.08
74054482|NCT03982069|147660644|OTHER|||||||0.91||||||Day 0 B/Victoria-B/Colorado|Chi-squared|||||||0.91
74054483|NCT03982069|147660644|OTHER|||||||0.31||||||Day 0 B/Yamagata-B/Phuket|Chi-squared|||||||0.31
74054484|NCT03982069|147660645|OTHER|||||||0.79||||||Day 0 A/H1N1-A/Brisbane|t-test, 2 sided|||||||0.79
74054485|NCT03982069|147660645|OTHER|||||||0.79||||||Day 0 A/H3N2-A/Kansas egg grown virus|t-test, 2 sided|||||||0.79
74054486|NCT03982069|147660645|OTHER|||||||0.56||||||Day 0 A/H3N2-A/Kansas cell grown virus|t-test, 2 sided|||||||0.56
74054487|NCT03982069|147660645|OTHER|||||||0.95||||||Day 0 B/Victoria-B/Colorado|t-test, 2 sided|||||||0.95
74054488|NCT03982069|147660645|OTHER|||||||0.44||||||Day 0 B/Yamagata-B/Phuket|t-test, 2 sided|||||||0.44
74054489|NCT03982069|147660645|OTHER||||||<|0.001||||||Day 28 for all listed variables|t-test, 2 sided|||||||<0.001
74054490|NCT03982069|147660646|OTHER|||||||0.83|||||||Chi-squared|Day 0: A/H1N1-A/Hawaii66-egg based antigen||||||0.83
74054491|NCT03982069|147660646|OTHER|||||||0.79|||||||Chi-squared|Day 0: A/H1N1-A/Hawaii70-cell based antigen||||||0.79
74054492|NCT03982069|147660646|OTHER|||||||0.65|||||||Chi-squared|Day 0: A/H1N1-A/Delaware||||||0.65
74054493|NCT03982069|147660646|OTHER|||||||0.06|||||||Chi-squared|Day 0: A/H3N2-A/Hong Kong||||||0.06
74054494|NCT03982069|147660646|OTHER|||||||0.98|||||||Chi-squared|Day 0: B/Victoria-B/Washington||||||0.98
74054495|NCT03982069|147660646|OTHER|||||||0.24|||||||Chi-squared|Day 0: B/Yamagata-B/Phuket||||||0.24
74100139|NCT01371747|147749310|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|81.6|||||TWO_SIDED|95.0|68.0|91.2|||||2-sided 95% exact binomial CI|||91.2|68.0|
74054496|NCT03982069|147660646|OTHER||||||<|0.01|||||||Chi-squared|Day 28: A/H1N1-A/Hawaii66-egg based antigen, A/H1N1-A/Hawaii70-cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket||||||<0.01
74054497|NCT03982069|147660646|OTHER|||||||0.66|||||||Chi-squared|A/H3N2-A/Hong Kong||||||0.66
74054498|NCT03982069|147660647|OTHER|||||||0.22||||||Day 0: A/H1N1-A/Hawaii66 egg based antigen|t-test, 2 sided|||||||0.22
74054499|NCT03982069|147660647|OTHER|||||||0.25||||||Day 0: A/H1N1-A/Hawaii70 cell based antigen|t-test, 2 sided|||||||0.25
74054500|NCT03982069|147660647|OTHER|||||||0.13||||||Day 0: A/H1N1-A/Delaware|t-test, 2 sided|||||||0.13
74054501|NCT03982069|147660647|OTHER|||||||0.06||||||Day 0: A/H3N2-A/Hong Kong|t-test, 2 sided|||||||0.06
74054502|NCT03982069|147660647|OTHER|||||||0.78||||||Day 0: B/Victoria-B/Washington|t-test, 2 sided|||||||0.78
74054503|NCT03982069|147660647|OTHER|||||||0.36||||||Day 0: B/Yamagata-B/Phuket|t-test, 2 sided|||||||0.36
74054504|NCT03982069|147660647|OTHER||||||<|0.0001||||||Day 28: A/H1N1-A/Hawaii66 egg based antigen, A/H1N1-A/Hawaii70 cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket|t-test, 2 sided|||||||<0.0001
74054505|NCT03982069|147660647|OTHER|||||||0.01||||||Day 28: A/H3N2-A/Hong Kong|t-test, 2 sided|||||||0.01
73881621|NCT03192176|147297635|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.93||0.0178|TWO_SIDED|95.0|-4.03|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.38|-4.03|0.0178
74054506|NCT03970330|147660656|SUPERIORITY||Mean Difference (Final Values)|1123.0||||0.2|TWO_SIDED|95.0|-755.0|3000.0|||t-test, 2 sided||Difference calculated as Naltrexone minus Placebo|||3000|-755|0.20
74054507|NCT03970330|147660657|SUPERIORITY||Mean Difference (Final Values)|28.9||||0.06|TWO_SIDED|95.0|-1.9|59.6|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at BASELINE||59.6|-1.9|0.06
74054508|NCT03970330|147660657|SUPERIORITY||Mean Difference (Final Values)|10.4||||0.48|TWO_SIDED|95.0|-20.3|41.2|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 4||41.2|-20.3|0.48
74054509|NCT03970330|147660657|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.21|TWO_SIDED|95.0|-11.8|49.6|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 8||49.6|-11.8|0.21
74054510|NCT03970330|147660657|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.3|TWO_SIDED|95.0|-15.2|46.2|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 12||46.2|-15.2|0.30
74054511|NCT03970330|147660657|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.65|TWO_SIDED|95.0|-24.0|37.5|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 16||37.5|-24.0|0.65
74054512|NCT03970330|147660658|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 4||||0.07
74054513|NCT03970330|147660658|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.07
74054514|NCT03970330|147660658|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.06
74054515|NCT03970330|147660658|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||1.00
74054516|NCT03970330|147660659|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Comparison of treament groups at WEEK 4||||0.29
74054517|NCT03970330|147660659|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.24
74054518|NCT03970330|147660659|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.20
74054519|NCT03970330|147660659|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||0.53
74054520|NCT03970330|147660660|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 4||||0.37
74054521|NCT03970330|147660660|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.39
74054522|NCT03970330|147660660|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.37
74054523|NCT03970330|147660660|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||0.39
74054524|NCT03970330|147660661|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.08|TWO_SIDED|95.0|-0.6|9.2|||t-test, 2 sided||Difference calculated as Naltrexone minus Placebo|||9.2|-0.6|0.08
74054525|NCT02452892|147660689|SUPERIORITY|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p\<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.307||||||"P-value displayed for 60min.~Mixed Model Repeated Measures (MMRM) model."|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.||Comparisons of 60 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS \& sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.||||0.307
74100140|NCT01371747|147749310|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|88.9|||||TWO_SIDED|95.0|75.9|96.3|||||2-sided 95% exact binomial CI|||96.3|75.9|
74100141|NCT01371747|147749310|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|86.7|||||TWO_SIDED|95.0|59.5|98.3|||||2-sided 95% exact binomial CI|||98.3|59.5|
74100142|NCT01371747|147749310|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|89.5|||||TWO_SIDED|95.0|66.9|98.7|||||2-sided 95% exact binomial CI|||98.7|66.9|
74054526|NCT02452892|147660689|SUPERIORITY|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p\<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.859||||||P-value displayed for 20min. Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.||Comparisons of 20 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS \& sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.||||0.859
74054527|NCT02452892|147660690|SUPERIORITY|||||||0.966||||||P-value is not adjusted for multiple comparisons. P-value was estimated from Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 2 baseline HAM-D6 total score, treatment, visit, treatment\*visit, age, \& gender included in model. Visit was the repeated measure within subject.||||||0.966
74054528|NCT02452892|147660691|SUPERIORITY|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.294||||||For 60 min LFMS, P-value not adjusted for multiple comparisons. P-value estimated using LR model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response||||||0.294
74054529|NCT02452892|147660691|SUPERIORITY|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.232||||||For 20min. LFMS, P-value not adjusted for multiple comparisons. P-value estimated using Logistic Regression model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response||||||0.232
74054530|NCT02452892|147660692|SUPERIORITY|||||||0.0932||||||P-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.||||0.0932
74054531|NCT02452892|147660692|SUPERIORITY|||||||0.7509||||||The p-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.||||0.7509
74054532|NCT02452892|147660693|SUPERIORITY|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.2672||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.||||||0.2672
74054533|NCT02452892|147660693|SUPERIORITY|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.166||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.||||||0.1660
74054534|NCT02452892|147660694|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~* All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~* The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~* The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0307
74054535|NCT02452892|147660694|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3537||||||"P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.~."|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.3537
74054536|NCT02452892|147660695|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0848||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0848
74100143|NCT01371747|147749310|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|93.3|||||TWO_SIDED|95.0|68.1|99.8|||||2-sided 95% exact binomial CI|||99.8|68.1|
74100144|NCT00580788|147749321|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTHrP 2 and PTHrP 5 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
74054537|NCT02452892|147660695|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.593||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where Incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.5930
74054538|NCT02452892|147660696|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0307
74054539|NCT02452892|147660696|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3907||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.3907
74054540|NCT02117024|147660697|SUPERIORITY|||||||0.0011|||||||Log Rank|||||||0.0011
74054541|NCT02117024|147660697|OTHER||Hazard Ratio (HR)|1.0|||<|0.05|TWO_SIDED||||||Other|||With only 50% of enrollment complete prior to study termination by sponsor, insufficient sample size exists to fully complete efficacy analysis.||||<0.05
74054542|NCT05047601|147660738|SUPERIORITY||Risk Ratio (RR)|0.702||||0.1722|TWO_SIDED|95.0|0.422|1.167|||Generalized estimating equation (GEE)|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.167|0.422|0.1722
74054543|NCT05047601|147660738|SUPERIORITY||Risk Ratio (RR)|0.645||||0.1163|TWO_SIDED|95.0|0.373|1.115|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.115|0.373|0.1163
74054544|NCT05047601|147660740|SUPERIORITY||Risk Ratio (RR)|0.88||||0.6766|TWO_SIDED|95.0|0.484|1.602|||GEE|Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.||||1.602|0.484|0.6766
74054545|NCT05047601|147660740|SUPERIORITY||Risk Ratio (RR)|0.809||||0.507|TWO_SIDED|95.0|0.433|1.512|||GEE|Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.||||1.512|0.433|0.5070
74054546|NCT05047601|147660742|SUPERIORITY||Risk Ratio (RR)|0.672||||0.1869|TWO_SIDED|95.0|0.373|1.213|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.213|0.373|0.1869
74054547|NCT05047601|147660742|SUPERIORITY||Risk Ratio (RR)|0.633||||0.1221|TWO_SIDED|95.0|0.355|1.13|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.130|0.355|0.1221
74054548|NCT05047601|147660743|SUPERIORITY|||||||0.0368|||||||Log Rank|||||||0.0368
74054549|NCT05047601|147660743|SUPERIORITY|||||||0.0186|||||||Log Rank|||||||0.0186
74054550|NCT05047601|147660744|SUPERIORITY||Risk Ratio (RR)|0.75||||0.4126|TWO_SIDED|95.0|0.378|1.491|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.491|0.378|0.4126
74054551|NCT05047601|147660744|SUPERIORITY||Risk Ratio (RR)|1.244||||0.4273|TWO_SIDED|95.0|0.725|2.135|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||2.135|0.725|0.4273
74054552|NCT05047601|147660745|SUPERIORITY||Risk Ratio (RR)|0.726||||0.1333|TWO_SIDED|95.0|0.478|1.103|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.103|0.478|0.1333
74054553|NCT05047601|147660745|SUPERIORITY||Risk Ratio (RR)|0.953||||0.8088|TWO_SIDED|95.0|0.645|1.408|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.408|0.645|0.8088
74054554|NCT05047601|147660753|SUPERIORITY||LS Mean Ratio|0.969||||0.7991|TWO_SIDED|95.0|0.758|1.238|||Negative binomial regression model|||||1.238|0.758|0.7991
74054555|NCT05047601|147660753|SUPERIORITY||LS Mean Ratio|0.847||||0.1985|TWO_SIDED|95.0|0.657|1.091|||Negative binomial regression model|||||1.091|0.657|0.1985
74054556|NCT03137173|147660763|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% confidence interval (CI) of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the Cochran-Mantel-Haenszel (CMH) weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|3.3|||||TWO_SIDED|95.0|-1.2|7.8||||||||7.8|-1.2|
74100145|NCT00580788|147749321|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p value corresponds to a decrease by Day 8 compared to baseline in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.01
74054557|NCT03137173|147660764|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-3.5|5.6||||||||5.6|-3.5|
74054558|NCT03137173|147660765|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin plus aztreonam) using a 10% non-inferiority margin in the CE populations. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|2.7|||||TWO_SIDED|95.0|-0.3|5.6||||||||5.6|-0.3|
74054559|NCT00911508|147660817|SUPERIORITY||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.65|1.15||||||||1.15|0.65|
74054560|NCT00911508|147660818|SUPERIORITY||Cox Proportional Hazard|0.85|||||TWO_SIDED|95.0|0.6|1.21||||||||1.21|0.60|
74054561|NCT00911508|147660819|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.74|0.93||||||||0.93|0.74|
74054562|NCT00911508|147660820|SUPERIORITY||Cox Proportional Hazard|0.88|||||TWO_SIDED|95.0|0.72|1.09||||||||1.09|0.72|
74054563|NCT00911508|147660821|SUPERIORITY||Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.53|1.68||||||||1.68|0.53|
74054564|NCT00911508|147660822|SUPERIORITY||Cox Proportional Hazard|0.87|||||TWO_SIDED|95.0|0.51|1.51||||||||1.51|0.51|
74054565|NCT00911508|147660823|SUPERIORITY||Cox Proportional Hazard|0.76|||||TWO_SIDED|95.0|0.33|1.72||||||||1.72|0.33|
74054566|NCT00911508|147660824|SUPERIORITY||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.41|3.09||||||||3.09|0.41|
73888167|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|220.3||||0.0019|TWO_SIDED|95.0|82.6|358.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||358.0|82.6|0.0019
74054567|NCT00911508|147660825|SUPERIORITY||Cox Proportional Hazard|0.52|||||TWO_SIDED|95.0|0.45|0.6||||||||0.60|0.45|
74054568|NCT00911508|147660826|SUPERIORITY||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.77|0.97||||||||0.97|0.77|
74054569|NCT00911508|147660827|SUPERIORITY||Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|3.7|6.9|||Mixed Models Analysis|||12 Month||6.9|3.7|<0.001
74054570|NCT00911508|147660827|SUPERIORITY||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED|95.0|2.1|4.8|||Mixed Models Analysis|||5 Years||4.8|2.1|<0.001
74054571|NCT00911508|147660828|SUPERIORITY||Mean Difference (Net)|-1.7||||0.001|TWO_SIDED|95.0|-2.3|-1.2|||Mixed Models Analysis|||12 Month||-1.2|-2.3|0.001
74054572|NCT00911508|147660828|SUPERIORITY||Mean Difference (Net)|-1.4||||0.001|TWO_SIDED|95.0|-1.9|-0.9|||Mixed Models Analysis|||5 Year||-0.9|-1.9|0.001
74054573|NCT00911508|147660829|SUPERIORITY||Mean Difference (Net)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.0|-1.1|||Mixed Models Analysis|||12 Month||-1.1|-2.0|<0.001
74054574|NCT00911508|147660829|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||5 Year||-0.4|-1.7|<0.001
74054575|NCT01409382|147660833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|1.5|7.6|||Chi-squared|||Take home babies||7.6|1.5|<0.05
74054576|NCT02022566|147660850|OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
74054577|NCT02022566|147660851|OTHER|Described elsewhere|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
74054578|NCT01789476|147660867|SUPERIORITY_OR_OTHER||||||<|0.05||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.05
74054579|NCT01789476|147660868|SUPERIORITY_OR_OTHER||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.03
74054580|NCT01789476|147660869|SUPERIORITY_OR_OTHER||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.03
74054581|NCT00965458|147660873|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.065
74054582|NCT00965458|147660874|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.019
74054583|NCT00965458|147660874|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.002
74054584|NCT00965458|147660875|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.065
74054585|NCT00965458|147660875|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.015
74054586|NCT00965458|147660876|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean insulin use comparison||||0.020
74054587|NCT00965458|147660876|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean insulin use comparison||||0.002
74054588|NCT00965458|147660877|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Baseline to Week 52||||<0.001
74054589|NCT00965458|147660877|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Week 52 to Week 104||||<0.001
74054590|NCT00965458|147660878|SUPERIORITY_OR_OTHER|||||||0.746|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean HbA1C comparison||||0.746
74054591|NCT00965458|147660878|SUPERIORITY_OR_OTHER|||||||0.942|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean HbA1C comparison||||0.942
74054592|NCT00994123|147660882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.008|TWO_SIDED|95.0|0.16|0.76|||Log Rank|||||0.76|0.16|0.008
74054593|NCT00994123|147660882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.15||||0.059|TWO_SIDED|95.0|0.97|4.76|||Log Rank|||||4.76|0.97|0.059
74054594|NCT00692198|147660903|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.52|TWO_SIDED|95.0|0.79|1.12|||Log Rank|||||1.12|0.79|0.52
74054595|NCT00692198|147660904|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.53|TWO_SIDED|95.0|0.64|1.25|||Log Rank||Hazard ratio, LTOT vs No LTOT|||1.25|0.64|0.53
74054596|NCT00692198|147660905|SUPERIORITY_OR_OTHER||Rate ratio|1.01||||0.81|TWO_SIDED|95.0|0.91|1.13|||Fisher Exact||Rate ratio, LTOT vs No LTOT|||1.13|0.91|0.81
74054597|NCT00692198|147660907|SUPERIORITY_OR_OTHER||Rate ratio|1.08||||0.12|TWO_SIDED|95.0|0.98|1.19|||Fisher Exact||Rate ratio, LTOT vs No LTOT|||1.19|0.98|0.12
74054598|NCT00692198|147660908|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
74054599|NCT00692198|147660909|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
74054600|NCT00692198|147660910|SUPERIORITY_OR_OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
74054601|NCT00692198|147660911|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
74054602|NCT00692198|147660912|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
74054603|NCT00692198|147660913|SUPERIORITY_OR_OTHER|||||||0.41|||||||t-test, 2 sided|||||||0.41
74054604|NCT00692198|147660914|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.09|||||TWO_SIDED|95.0|0.54|8.0|||||Relative risk, LTOT vs No LTOT|||8.00|0.54|
74054605|NCT00692198|147660915|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
74054606|NCT00692198|147660916|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
74054607|NCT05111548|147660917|SUPERIORITY|||||||0.923|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.923
74054608|NCT05111548|147660918|SUPERIORITY|||||||0.11|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.110
74054609|NCT05111548|147660919|SUPERIORITY|||||||0.818|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.818
74054610|NCT05111548|147660920|SUPERIORITY|||||||0.13|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.130
74054611|NCT00151775|147660927|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||0.0008
74054612|NCT00151775|147660927|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Weight adjusted dosage||||<0.0001
74054613|NCT00151775|147660927|SUPERIORITY_OR_OTHER|||||||0.0032||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||0.0032
74054614|NCT00151775|147660927|SUPERIORITY_OR_OTHER|||||||0.0265||95.0|||||Regression, Linear|||Weight adjusted dosage||||0.0265
74054615|NCT00151775|147660927|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||<0.0001
74054616|NCT00151775|147660927|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Weight adjusted dosage||||<0.0001
74054617|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|0.69||||0.0008||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0008
74054618|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|-0.057||||0.0026||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0026
74054619|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|-0.85||||0.0032||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0032
74054620|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|-0.58||||0.0125||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0125
74054621|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|-0.75|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
74054622|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|-0.57|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
74054623|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|-8.97|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
74054624|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|-8.15|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
74054625|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|-7.17||||0.0265||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0265
74054626|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|-6.85||||0.0084||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0084
74054627|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|-8.36|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
74054628|NCT00151775|147660928|SUPERIORITY_OR_OTHER||Slope|-7.71|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
74054629|NCT00151775|147660929|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.58||||0.0093|TWO_SIDED|95.0|-6.27|-0.89|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.||-0.89|-6.27|0.0093
74054630|NCT00151775|147660929|SUPERIORITY_OR_OTHER||LS Mean difference|-3.49||||0.0052|TWO_SIDED|95.0|-5.92|-1.05|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.||-1.05|-5.92|0.0052
74054631|NCT00151775|147660929|SUPERIORITY_OR_OTHER||LS Mean difference|-2.57||||0.133|TWO_SIDED|95.0|-5.93|0.79|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.||0.79|-5.93|0.1330
74054632|NCT00151775|147660929|SUPERIORITY_OR_OTHER||LS Mean difference|-1.38||||0.3442|TWO_SIDED|95.0|-4.27|1.5|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.||1.50|-4.27|0.3442
74054633|NCT00151775|147660929|SUPERIORITY_OR_OTHER||LS Mean difference|-3.16||||0.0029|TWO_SIDED|95.0|-5.24|-1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested||-1.09|-5.24|0.0029
74054634|NCT00151775|147660929|SUPERIORITY_OR_OTHER||LS Mean difference|-2.8||||0.0032|TWO_SIDED|95.0|-4.65|-0.95|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.||-0.95|-4.65|0.0032
74054635|NCT00151775|147660930|SUPERIORITY_OR_OTHER||LS Mean difference|-2.82||||0.2113|TWO_SIDED|95.0|-7.29|1.65|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested.||1.65|-7.29|0.2113
74054636|NCT00151775|147660930|SUPERIORITY_OR_OTHER||LS Mean difference|-2.92||||0.1496|TWO_SIDED|95.0|-6.92|1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.||1.09|-6.92|0.1496
74054637|NCT04516291|147660933|OTHER||Least Square (LS) Mean difference|-22.4|STANDARD_ERROR_OF_MEAN|4.93|<|0.001|TWO_SIDED|95.0|-32.1|-12.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-12.7|-32.1|<0.001
74054638|NCT04516291|147660933|OTHER||LS Mean difference|-22.0|STANDARD_ERROR_OF_MEAN|4.88|<|0.001|TWO_SIDED|95.0|-31.7|-12.4|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-12.4|-31.7|<0.001
74054639|NCT04516291|147660933|OTHER||LS Mean difference|-24.1|STANDARD_ERROR_OF_MEAN|5.05|<|0.001|TWO_SIDED|95.0|-34.1|-14.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-14.2|-34.1|<0.001
74054640|NCT04516291|147660933|OTHER||LS Mean difference|-27.7|STANDARD_ERROR_OF_MEAN|4.09|<|0.001|TWO_SIDED|95.0|-35.7|-19.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-19.6|-35.7|<0.001
74054641|NCT04516291|147660933|OTHER||LS Mean difference|-26.6|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-34.5|-18.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-18.8|-34.5|<0.001
74054642|NCT04516291|147660933|OTHER||LS Mean difference|-24.7|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-32.5|-16.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-16.9|-32.5|<0.001
74054643|NCT04516291|147660933|OTHER||LS Mean difference|-26.5|STANDARD_ERROR_OF_MEAN|4.51|<|0.001|TWO_SIDED|95.0|-35.4|-17.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-17.6|-35.4|<0.001
74054644|NCT04516291|147660935|OTHER||LS Mean difference|-44.0|STANDARD_ERROR_OF_MEAN|6.66|<|0.001|TWO_SIDED|95.0|-57.1|-30.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-30.8|-57.1|<0.001
74054645|NCT04516291|147660935|OTHER||LS Mean difference|-43.8|STANDARD_ERROR_OF_MEAN|6.64|<|0.001|TWO_SIDED|95.0|-56.9|-30.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-30.7|-56.9|<0.001
74054646|NCT04516291|147660935|OTHER||LS Mean difference|-41.3|STANDARD_ERROR_OF_MEAN|6.85|<|0.001|TWO_SIDED|95.0|-54.8|-27.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-27.8|-54.8|<0.001
74054647|NCT04516291|147660935|OTHER||LS Mean difference|-50.5|STANDARD_ERROR_OF_MEAN|5.54|<|0.001|TWO_SIDED|95.0|-61.4|-39.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-39.6|-61.4|<0.001
74054648|NCT04516291|147660935|OTHER||LS Mean difference|-45.9|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-56.5|-35.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-35.2|-56.5|<0.001
74054649|NCT04516291|147660935|OTHER||LS Mean difference|-50.7|STANDARD_ERROR_OF_MEAN|5.35|<|0.001|TWO_SIDED|95.0|-61.2|-40.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-40.1|-61.2|<0.001
74054650|NCT04516291|147660935|OTHER||LS Mean difference|-56.8|STANDARD_ERROR_OF_MEAN|6.14|<|0.001|TWO_SIDED|95.0|-68.9|-44.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-44.7|-68.9|<0.001
74054651|NCT04516291|147660935|OTHER||LS Mean difference|-15.1|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-23.7|-6.5|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-6.5|-23.7|<0.001
74054652|NCT04516291|147660935|OTHER||LS Mean difference|-10.6|STANDARD_ERROR_OF_MEAN|4.34||0.015|TWO_SIDED|95.0|-19.2|-2.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-2.1|-19.2|0.015
74054653|NCT04516291|147660935|OTHER||LS Mean difference|-11.5|STANDARD_ERROR_OF_MEAN|4.49||0.011|TWO_SIDED|95.0|-20.3|-2.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-2.7|-20.3|0.011
74054654|NCT04516291|147660935|OTHER||LS Mean difference|-12.5|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-19.7|-5.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-5.3|-19.7|<0.001
74054655|NCT04516291|147660935|OTHER||LS Mean difference|-12.6|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-19.5|-5.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-5.6|-19.5|<0.001
74054656|NCT04516291|147660935|OTHER||LS Mean difference|-6.0|STANDARD_ERROR_OF_MEAN|3.56||0.095|TWO_SIDED|95.0|-13.0|1.0|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||1.0|-13.0|0.095
74054657|NCT04516291|147660935|OTHER||LS Mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.01||0.036|TWO_SIDED|95.0|-16.4|-0.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-0.6|-16.4|0.036
74054658|NCT04516291|147660935|OTHER||LS Mean difference|-10.0|STANDARD_ERROR_OF_MEAN|6.55||0.129|TWO_SIDED|95.0|-22.9|2.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.9|-22.9|0.129
74054659|NCT04516291|147660935|OTHER||LS Mean difference|-7.9|STANDARD_ERROR_OF_MEAN|6.65||0.238|TWO_SIDED|95.0|-21.0|5.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||5.2|-21.0|0.238
74054660|NCT04516291|147660935|OTHER||LS Mean difference|-11.4|STANDARD_ERROR_OF_MEAN|6.73||0.09|TWO_SIDED|95.0|-24.7|1.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||1.8|-24.7|0.090
74054661|NCT04516291|147660935|OTHER||LS Mean difference|-16.0|STANDARD_ERROR_OF_MEAN|5.44||0.004|TWO_SIDED|95.0|-26.7|-5.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||-5.3|-26.7|0.004
74054662|NCT04516291|147660935|OTHER||LS Mean difference|-14.5|STANDARD_ERROR_OF_MEAN|5.38||0.008|TWO_SIDED|95.0|-25.1|-3.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||-3.9|-25.1|0.008
74054663|NCT04516291|147660935|OTHER||LS Mean difference|-7.9|STANDARD_ERROR_OF_MEAN|5.28||0.136|TWO_SIDED|95.0|-18.3|2.5|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.5|-18.3|0.136
74054664|NCT04516291|147660935|OTHER||LS Mean difference|-9.0|STANDARD_ERROR_OF_MEAN|6.01||0.138|TWO_SIDED|95.0|-20.8|2.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.9|-20.8|0.138
74054665|NCT04516291|147660937|OTHER||LS Mean difference|-69.9|STANDARD_ERROR_OF_MEAN|5.97|<|0.001|TWO_SIDED|95.0|-81.6|-58.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-58.1|-81.6|<0.001
74054666|NCT04516291|147660937|OTHER||LS Mean difference|-79.6|STANDARD_ERROR_OF_MEAN|6.03|<|0.001|TWO_SIDED|95.0|-91.5|-67.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-67.7|-91.5|<0.001
74054667|NCT04516291|147660937|OTHER||LS Mean difference|-77.1|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-89.4|-64.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-64.9|-89.4|<0.001
74054668|NCT04516291|147660937|OTHER||LS Mean difference|-86.3|STANDARD_ERROR_OF_MEAN|5.04|<|0.001|TWO_SIDED|95.0|-96.2|-76.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-76.3|-96.2|<0.001
74054669|NCT04516291|147660937|OTHER||LS Mean difference|-80.4|STANDARD_ERROR_OF_MEAN|4.82|<|0.001|TWO_SIDED|95.0|-89.9|-70.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-70.9|-89.9|<0.001
74054670|NCT04516291|147660937|OTHER||LS Mean difference|-92.2|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|TWO_SIDED|95.0|-101.9|-82.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-82.6|-101.9|<0.001
74100146|NCT00580788|147749323|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61|TWO_SIDED|||||The reported p-value corresponds to all Arms/Groups at all time points compared to baseline|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.61
74054671|NCT04516291|147660937|OTHER||LS Mean difference|-95.2|STANDARD_ERROR_OF_MEAN|5.59|<|0.001|TWO_SIDED|95.0|-106.2|-84.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-84.2|-106.2|<0.001
74054672|NCT03039686|147660939|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-2.17|1.27|||||Based on the MMRM using an unstructured covariance matrix -change = Baseline + Age Interactive response system (IXRS) Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||1.27|-2.17|
74054673|NCT03039686|147660939|SUPERIORITY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.1|2.26|||||Based on the MMRM using an unstructured covariance matrix -change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||2.26|-1.10|
74054674|NCT03039686|147660941|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.21|0.2|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.20|-0.21|
74054675|NCT03039686|147660941|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.12|0.27|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.27|-0.12|
74054676|NCT03039686|147660943|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.0|0.06|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.06|-0.00|
74054677|NCT03039686|147660943|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.0|0.06|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.06|-0.00|
74054678|NCT03039686|147660945|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.08|0.27|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.27|-0.08|
74054679|NCT03039686|147660945|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.17|0.18|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.18|-0.17|
74054680|NCT03039686|147660947|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|-6.76|2.77|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||2.77|-6.76|
74054681|NCT03039686|147660947|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|-3.71|5.63|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||5.63|-3.71|
74054682|NCT03039686|147660950|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|11.5|||TWO_SIDED|95.0|-21.1|24.6|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||24.6|-21.1|
74054683|NCT03039686|147660950|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|11.3|||TWO_SIDED|95.0|-11.0|33.6|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||33.6|-11.0|
74054684|NCT02181634|147660966|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.099|TWO_SIDED|95.0|0.86|4.75|||Log Rank|||||4.75|0.86|0.099
74054685|NCT02181634|147660967|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.34|TWO_SIDED|95.0|0.64|3.71|||Log Rank|||||3.71|0.64|0.34
74054686|NCT02843282|147660978|SUPERIORITY||Mean Difference (Net)|0.69||||0.04|TWO_SIDED||||||Regression, Linear|||||||0.040
74054687|NCT02843282|147660979|SUPERIORITY||Mean Difference (Net)|0.98||||0.004|TWO_SIDED||||||Regression, Linear|||||||0.004
74100147|NCT00580788|147749324|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|Value The level of statistical significance was set at .05 (two-tailed)||||||<0.0001
74054688|NCT02843282|147660980|SUPERIORITY||Mean Difference (Net)|1.95|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
74054689|NCT02843282|147660981|SUPERIORITY||Mean Difference (Net)|0.52||||0.039|TWO_SIDED||||||Regression, Linear|||||||0.039
74054690|NCT02843282|147660982|SUPERIORITY||Mean Difference (Net)|0.42||||0.092|TWO_SIDED||||||Regression, Linear|||||||0.092
74054691|NCT02843282|147660983|SUPERIORITY||Mean Difference (Net)|6.58||||0.052|TWO_SIDED||||||Regression, Linear|||||||0.052
74054692|NCT02843282|147660984|SUPERIORITY||Mean Difference (Net)|0.52||||0.121|TWO_SIDED||||||Regression, Linear|||||||0.121
74054693|NCT02843282|147660985|SUPERIORITY||Mean Difference (Net)|1.23||||0.019|TWO_SIDED||||||Regression, Linear|||||||0.019
74054694|NCT02843282|147660986|SUPERIORITY||Mean Difference (Net)|0.37||||0.278|TWO_SIDED||||||Regression, Linear|||||||0.278
74054695|NCT02843282|147660987|SUPERIORITY||Mean Difference (Net)|7.0||||0.095|TWO_SIDED||||||Regression, Linear|||||||0.095
74054696|NCT02843282|147660988|OTHER||Mean Difference (Net)|0.15|||<|0.01|TWO_SIDED||||||Whole brain voxel-wise correlation analy|||||||< 0.01
74054697|NCT02843282|147660989|SUPERIORITY||Mean Difference (Net)|1.22||||0.001|TWO_SIDED||||||Regression, Linear|||||||0.001
74054698|NCT02843282|147660990|SUPERIORITY||Mean Difference (Net)|1.33||||0.007|TWO_SIDED||||||Regression, Linear|||||||0.007
74054699|NCT01101321|147660997|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|96.14|104.96|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||104.96|96.14|
74054700|NCT01101321|147660998|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||TWO_SIDED|90.0|95.44|101.73|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.73|95.44|
74054701|NCT01101321|147660999|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||TWO_SIDED|90.0|95.42|101.7|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.70|95.42|
74054702|NCT02681094|147661000|SUPERIORITY||LS mean difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.55|-0.24|||Mixed Models Analysis|||||-0.24|-0.55|<0.0001
74054703|NCT02681094|147661000|SUPERIORITY||LS mean difference|-0.34|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.19|||Mixed Models Analysis|||||-0.19|-0.50|<0.0001
74054704|NCT02681094|147661001|SUPERIORITY||Risk Difference (RD)|19.8|||<|0.0001|TWO_SIDED|95.0|12.7|26.9|||Method of Zhang, Tsiatis, and Davidian|||||26.9|12.7|<0.0001
74054705|NCT02681094|147661001|SUPERIORITY||Risk Difference (RD)|11.7||||0.0018|TWO_SIDED|95.0|4.4|19.1|||Method of Zhang, Tsiatis, and Davidian|||||19.1|4.4|0.0018
74054706|NCT02681094|147661002|SUPERIORITY||LS mean difference|-7.58||||0.0135|TWO_SIDED|95.0|-13.59|-1.57|||Mixed Models Analysis|||||-1.57|-13.59|0.0135
74054707|NCT02681094|147661002|SUPERIORITY||LS mean difference|-14.88|||<|0.0001|TWO_SIDED|95.0|-20.85|-8.91|||Mixed Models Analysis|||||-8.91|-20.85|<0.0001
74054708|NCT02681094|147661003|SUPERIORITY||LS mean difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.11|-1.09|||Mixed Models Analysis|||||-1.09|-2.11|<0.0001
74054709|NCT01270139|147661004|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control||||<0.05
74054710|NCT01270139|147661005|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
74054711|NCT01270139|147661006|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control||||<0.05
74054712|NCT01270139|147661007|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
74054713|NCT01270139|147661008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|ONE_SIDED||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
74054714|NCT01270139|147661009|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|ONE_SIDED||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
74054715|NCT01270139|147661010|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
74054716|NCT01270139|147661011|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control||||<0.05
74054717|NCT01270139|147661012|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED||||||Chi-squared|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control||||<0.05
74054718|NCT01270139|147661013|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
74054719|NCT01270139|147661014|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control||||<0.05
74054720|NCT01270139|147661015|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
74054721|NCT01270139|147661016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control||||<0.05
74054722|NCT01270139|147661017|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
74054723|NCT01270139|147661018|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
74054724|NCT01270139|147661019|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
74054725|NCT01270139|147661020|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
74100148|NCT00580788|147749325|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<0.0001
74100149|NCT00580788|147749326|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time from baseline for all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>.05
74054726|NCT01270139|147661021|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|t-test, 2 sided|||Null hypothesis is ex-vivo arm with exposure of nanoparticles is superior to saline control.||||<0.05
74054727|NCT00134563|147661037|SUPERIORITY_OR_OTHER||Relative risk reduction (%)|31.5||||0.0005||||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 14 mg compared to placebo|"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and placebo~* H2: No difference between Teriflunomide 7 mg and placebo~The study was sized to detect a 25% relative risk reduction with teriflunomide in the 2-year relapse rate at a significance level of 0.050 with a power ≥95% anticipating a potential 20% 2-year dropout rate."||||0.0005
74054728|NCT00134563|147661037|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|31.2||||0.0002||||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 7 mg compared to placebo|||||0.0002
74054729|NCT00134563|147661038|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|29.8||||0.0279||||||"Step down approach:~* H1 tested only if both comparisons on the primary outcome measure were statistically significant~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and placebo~* H2: No difference between Teriflunomide 7 mg and placebo~The study was also sized to detect a 37% hazard rate reduction of an assumed disability progression hazard rate of 0.1783 in the placebo group and 0.1116 in the teriflunomide group by the end of 2 years with a power of 80% anticipating a potential 20% 2-year dropout rate."||||0.0279
74054730|NCT00134563|147661038|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|23.7||||0.0835||||||"Step down approach:~* H1 tested only if both comparisons on the primary outcome measure were statistically significant~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|||||0.0835
74054731|NCT00134563|147661039|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures \[MMRM\] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).||||0.0003
74054732|NCT00134563|147661039|SUPERIORITY_OR_OTHER|||||||0.0317||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures \[MMRM\] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).||||0.0317
74054733|NCT00134563|147661042|SUPERIORITY_OR_OTHER|||||||0.8271||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||||||0.8271
74054734|NCT00134563|147661042|SUPERIORITY_OR_OTHER|||||||0.3861||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||||||0.3861
74054735|NCT00148109|147661083|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||Estimate a 4 month progression-free survival rate for each group.||||<0.05
74054736|NCT01098266|147661086|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.58|TWO_SIDED|95.0|0.75|1.18||The log-rank test (unstratified) was used to compare the two treatment arms. In addition, a stratified version of the log-rank test was performed with the stratification factors used for randomization.|Log Rank|Cox regression analyses (unstratified and stratified) were performed to assess the influence of baseline covariates in an exploratory manner.||Study with one control per experimental patient, an accrual interval of 24 months, and an additional FU after the accrual interval of 12 months.If the true HR of experimental relative to control patients was 0.726, then 195 experimental patients and 195 control patients were required to be able to reject the null hypothesis that the experimental and control survival curves were equal with probability (power)0.80 Type I error probability associated with this test of this null hypothesis was 0.05||1.18|0.75|0.58
74054737|NCT01098266|147661087|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.65|TWO_SIDED|95.0|0.78|1.17|||Log Rank|Cox regression analyses (unstratified and stratified) was performed to assess the influence of baseline covariates in an exploratory manner.||The log-rank test (unstratified and stratified) was used at an alpha level of 5% to test for differences in PFS between the two treatment arms. Kaplan-Meier curves and estimates were provided.||1.17|0.78|0.65
74054738|NCT01098266|147661088|SUPERIORITY||Odds Ratio (OR)|1.13||||0.62|TWO_SIDED|95.0|0.76|1.68|||Fisher Exact||Logistic regression analyses were performed to assess the influence of baseline covariates in an exploratory manner|Difference in DCR between the two treatment arms were tested using a chi-squared test with 95% confidence intervals calculated in each treatment arm.||1.68|0.76|0.62
74054739|NCT01098266|147661091|OTHER|Two-sided log-rank test was used to compare time to symptomatic progression between treatment arms. Median and 95% confidence limits for the time to symptomatic progression were estimated using Kaplan-Meier survival methodology. Estimates of the treatment effect were expressed as hazard ratio including 95% confidence intervals.|Hazard Ratio (HR)|0.92||||0.5806|TWO_SIDED|95.0|0.68|1.26|||Log Rank|||QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100(the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all 6 major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.||1.26|0.68|0.5806
74054740|NCT00649220|147661100|SUPERIORITY_OR_OTHER|||||||0.22626||95.0|||||t-test, 2 sided|||Two-side, paired t-test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline||||0.22626
74054741|NCT00649220|147661100|SUPERIORITY_OR_OTHER|||||||0.34192||95.0|||||Wilcoxon signed rank test|||Wilcoxon signed rank test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline||||0.34192
74054742|NCT01111058|147661117|SUPERIORITY||Difference in survival proportions|0.0022||||0.9|TWO_SIDED|95.0|-0.33|0.33|||Comparison of Kaplan-Meier estimates|Used Greenwood standard errors||||0.33|-0.33|0.90
74054743|NCT01111058|147661117|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
74054744|NCT01111058|147661118|SUPERIORITY|||||||0.086|||||||Fisher Exact|||||||0.086
74054745|NCT01733758|147661126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.55|||||TWO_SIDED|95.0|-1.72|-1.39|||ANCOVA|||||-1.39|-1.72|
74054746|NCT01733758|147661126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.35|||||TWO_SIDED|95.0|-1.51|-1.18|||ANCOVA|||||-1.18|-1.51|
74054747|NCT01733758|147661126|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The first test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of least squares (LS) means (albiglutide 50 mg - placebo) is equal to zero.||||||<0.0001
74054748|NCT01733758|147661126|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The second test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of LS means (albiglutide 30 mg - placebo) is equal to zero.||||||<0.0001
74054749|NCT04594213|147661137|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054750|NCT04594213|147661138|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054751|NCT04594213|147661139|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054752|NCT04594213|147661140|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054753|NCT04594213|147661141|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054754|NCT04594213|147661142|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054755|NCT04594213|147661143|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054756|NCT04594213|147661144|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054757|NCT04594213|147661145|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054758|NCT04594213|147661146|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74054759|NCT04594213|147661147|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054760|NCT04594213|147661147|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054761|NCT04594213|147661148|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054762|NCT04594213|147661148|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054763|NCT04594213|147661149|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
74054764|NCT04594213|147661150|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74054765|NCT04594213|147661150|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74054766|NCT00538434|147661153|SUPERIORITY_OR_OTHER||Adjusted mean difference|-52.78|STANDARD_ERROR_OF_MEAN|11.4|<|0.0001|TWO_SIDED|95.0|-75.24|-30.32|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-30.32|-75.24|< 0.0001
74054767|NCT00538434|147661153|SUPERIORITY_OR_OTHER||Adjusted mean difference|-73.03|STANDARD_ERROR_OF_MEAN|11.29|<|0.0001|TWO_SIDED|95.0|-95.28|-50.78|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-50.78|-95.28|< 0.0001
74054768|NCT00538434|147661153|SUPERIORITY_OR_OTHER||Adjusted mean difference|-64.69|STANDARD_ERROR_OF_MEAN|11.28|<|0.0001|TWO_SIDED|95.0|-86.93|-42.45|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-42.45|-86.93|< 0.0001
74054769|NCT00538434|147661154|SUPERIORITY_OR_OTHER|||||||0.0313|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0313
74054770|NCT00538434|147661154|SUPERIORITY_OR_OTHER|||||||0.5793|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.5793
74054771|NCT00538434|147661154|SUPERIORITY_OR_OTHER|||||||0.4905|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4905
74054772|NCT00538434|147661155|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0062
74054773|NCT00538434|147661155|SUPERIORITY_OR_OTHER|||||||0.0943|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0943
74054774|NCT00538434|147661155|SUPERIORITY_OR_OTHER|||||||0.2955|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2955
74054775|NCT00538434|147661156|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.75|STANDARD_ERROR_OF_MEAN|6.48||0.4644|TWO_SIDED|95.0|-17.53|8.03||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||8.03|-17.53|0.4644
74054776|NCT00538434|147661156|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.47|STANDARD_ERROR_OF_MEAN|6.44||0.8196|TWO_SIDED|95.0|-14.17|11.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||11.23|-14.17|0.8196
74054777|NCT00538434|147661156|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.36|STANDARD_ERROR_OF_MEAN|6.36||0.8306|TWO_SIDED|95.0|-11.19|13.91||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||13.91|-11.19|0.8306
74054778|NCT00538434|147661156|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.38|STANDARD_ERROR_OF_MEAN|4.37||0.1459|TWO_SIDED|95.0|-15.01|2.24||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||2.24|-15.01|0.1459
74054779|NCT00538434|147661156|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.41|STANDARD_ERROR_OF_MEAN|4.38||0.4375|TWO_SIDED|95.0|-12.05|5.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||5.23|-12.05|0.4375
74054780|NCT00538434|147661156|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.43|STANDARD_ERROR_OF_MEAN|4.35||0.9217|TWO_SIDED|95.0|-9.0|8.15||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||8.15|-9.00|0.9217
74054781|NCT00538434|147661156|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.57|STANDARD_ERROR_OF_MEAN|7.82||0.8412|TWO_SIDED|95.0|-16.98|13.85||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||13.85|-16.98|0.8412
74054782|NCT00538434|147661156|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.54|STANDARD_ERROR_OF_MEAN|7.81||0.4794|TWO_SIDED|95.0|-20.94|9.87||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||9.87|-20.94|0.4794
74054783|NCT00538434|147661156|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.06|STANDARD_ERROR_OF_MEAN|7.66||0.8906|TWO_SIDED|95.0|-16.16|14.06||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||14.06|-16.16|0.8906
74100150|NCT00580788|147749327|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008|TWO_SIDED|||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.008
74100151|NCT00580788|147749327|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
74100152|NCT00580788|147749328|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
74100153|NCT00580788|147749328|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
74100154|NCT00580788|147749329|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
74100155|NCT00580788|147749329|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.01
74054784|NCT03814499|147661161|OTHER||Coefficient|-2.3|||<|0.01|TWO_SIDED||||||Regression, Linear|||||||<0.01
74100156|NCT00580788|147749330|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.001|TWO_SIDED|||||the reported p-value correspond to the decrease compared to baseline over time in the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.001
74054785|NCT03814499|147661162|OTHER||Coefficient|-3.8|||<|0.01|TWO_SIDED||||||Regression, Linear|||||||<0.01
74054786|NCT03814499|147661163|OTHER||Coefficient|369.9||||0.3269|TWO_SIDED||||||Regression, Linear|||||||0.3269
74054787|NCT03814499|147661164|OTHER||Coefficient|365.4||||0.4265|TWO_SIDED||||||Regression, Linear|||||||0.4265
74054788|NCT03814499|147661165|OTHER||Coefficient|264.3||||0.4782|TWO_SIDED||||||Regression, Linear|||||||0.4782
74054789|NCT03814499|147661166|OTHER||Coefficient|730.2||||0.2716|TWO_SIDED||||||Regression, Linear|||||||0.2716
74054790|NCT03814499|147661167|OTHER||Coefficient|-0.6||||0.4178|TWO_SIDED||||||Regression, Linear|||||||0.4178
73881622|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9675|TWO_SIDED|95.0|-1.02|0.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.98|-1.02|0.9675
73888168|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|106.0||||0.1298|TWO_SIDED|95.0|-31.5|243.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||243.5|-31.5|0.1298
74054791|NCT03814499|147661168|OTHER||Coefficient|-1.5||||0.2677|TWO_SIDED||||||Regression, Linear|||||||0.2677
74054792|NCT03814499|147661169|OTHER||Coefficient|-467.0||||0.3364|TWO_SIDED||||||Regression, Linear|||||||0.3364
74054793|NCT03814499|147661170|OTHER||Coefficient|-908.0||||0.1124|TWO_SIDED||||||Regression, Linear|||||||0.1124
74054794|NCT03814499|147661171|OTHER||Coefficient|479.2||||0.2649|TWO_SIDED||||||Regression, Linear|||||||0.2649
74054795|NCT03814499|147661172|OTHER||Coefficient|1114.3||||0.216|TWO_SIDED||||||Regression, Linear|||||||0.216
74054796|NCT03814499|147661173|OTHER||Coefficient|0.1||||0.9032|TWO_SIDED||||||Regression, Linear|||||||0.9032
74054797|NCT03814499|147661174|OTHER||Coefficient|-0.4||||0.7889|TWO_SIDED||||||Regression, Linear|||||||0.7889
74054798|NCT03814499|147661175|OTHER||Coefficient|7.0||||0.0242|TWO_SIDED||||||Regression, Linear|||||||0.0242
74054799|NCT03814499|147661176|OTHER||Coefficient|1.5||||0.5092|TWO_SIDED||||||Regression, Linear|||||||0.5092
74054800|NCT03814499|147661177|OTHER||Coefficient|-47.1||||0.3634|TWO_SIDED||||||Regression, Linear|||||||0.3634
74054801|NCT03814499|147661178|OTHER||Coefficient|-204.7||||0.0677|TWO_SIDED||||||Regression, Linear|||||||0.0677
74054802|NCT03814499|147661179|OTHER||Coefficient|-235.8||||0.156|TWO_SIDED||||||Regression, Linear|||||||0.156
74054803|NCT03814499|147661180|OTHER||Coefficient|-102.0||||0.3148|TWO_SIDED||||||Regression, Linear|||||||0.3148
74054804|NCT03814499|147661181|OTHER||Coefficient|-0.1||||0.9349|TWO_SIDED||||||Regression, Linear|||||||0.9349
74054805|NCT03814499|147661182|OTHER||Coefficient|-0.6||||0.7196|TWO_SIDED||||||Regression, Linear|||||||0.7196
74054806|NCT03814499|147661183|OTHER||Coefficient|4.7||||0.0542|TWO_SIDED||||||Regression, Linear|||||||0.0542
74054807|NCT03814499|147661184|OTHER||Coefficient|2.6||||0.4224|TWO_SIDED||||||Regression, Linear|||||||0.4224
74054808|NCT03814499|147661185|OTHER||Coeffiient|-118.9||||0.1247|TWO_SIDED||||||Regression, Linear|||||||0.1247
74054809|NCT03814499|147661186|OTHER||Coefficient|-135.2||||0.1461|TWO_SIDED||||||Regression, Linear|||||||0.1461
74054810|NCT03814499|147661187|OTHER||Coefficient|-154.2||||0.0699|TWO_SIDED||||||Regression, Linear|||||||0.0699
74054811|NCT03814499|147661188|OTHER||Coefficient|-164.6||||0.0901|TWO_SIDED||||||Regression, Linear|||||||0.0901
74054812|NCT01589185|147661190|SUPERIORITY|||||||0.3962||||||\< 0.1 is considered borderline significant|Fisher Exact|||The number (%) of patients who died on or before end of study (EOS) was compared among all 5 groups. The mITT population was used.||||0.3962
74054813|NCT02046993|147661194|SUPERIORITY_OR_OTHER|||||||0.27|||||||Chi-squared|||comparison of the percentage of patients doing HBPM between intervention and control group at baseline||||0.27
74054814|NCT02046993|147661194|SUPERIORITY_OR_OTHER|||||||0.02|||||||McNemar|||Comparison of percentage of subjects doing HBPM at 3rd month from baseline within intervention group||||.020
74054815|NCT02046993|147661194|SUPERIORITY_OR_OTHER|||||||0.06|||||||McNemar|||comparison in percentage of patients doing Home BP monitoring at 6th month from baseline within intervention group||||.060
74054816|NCT02046993|147661194|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||McNemar|||Change in the proportion of patients doing HBPM at 3 months from baseline within the control group||||.002
74054817|NCT02046993|147661194|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||McNemar|||Change in proportion of patients doing HBPM at 6 months from baseline within control group||||.009
74054818|NCT02046993|147661195|SUPERIORITY_OR_OTHER|||||||0.813|||||||t-test, 2 sided|||Comparison of baseline mean clinic systolic BP mCSBP readings between control and intervention||||0.813
74054819|NCT02046993|147661195|SUPERIORITY_OR_OTHER|||||||0.865|||||||t-test, 2 sided|||Comparison of baseline mean clinic diastolic BP mCDBP readings between control and intervention||||0.865
74054820|NCT02046993|147661195|SUPERIORITY_OR_OTHER|||||||0.476|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 3 months from baseline||||0.476
74054821|NCT02046993|147661195|SUPERIORITY_OR_OTHER|||||||0.14|||||||t-test, 2 sided|||Comparison of difference of mean clinic diastolic BP mCDBP readings between control and intervention at 3 months from baseline||||0.14
74054822|NCT02046993|147661195|SUPERIORITY_OR_OTHER|||||||0.495|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 6 months from baseline||||0.495
74054823|NCT02046993|147661195|SUPERIORITY_OR_OTHER|||||||0.967|||||||t-test, 2 sided|||Comparison of difference in mean clinic diastolic BP readings mCDBP between control and intervention at 6 months from baseline||||0.967
74054824|NCT02046993|147661196|SUPERIORITY_OR_OTHER|||||||0.819|||||||t-test, 2 sided|||Comparison of baselline SEMCD between telemonitoring group and enhanced usual care||||0.819
74054825|NCT02046993|147661196|SUPERIORITY_OR_OTHER|||||||0.512|||||||t-test, 2 sided|||Comparison of SEMCD at 3 months between telemonitoring group and enhanced usual care||||0.512
74054826|NCT02046993|147661196|SUPERIORITY_OR_OTHER|||||||0.325|||||||t-test, 2 sided|||Comparison of SEMCD at 6 months between telemonitoring group and enhanced usual care group||||0.325
74100157|NCT00580788|147749330|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p=value corresponds to % change compared to baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.01
74054827|NCT02046993|147661197|SUPERIORITY_OR_OTHER|||||||0.532|||||||t-test, 2 sided|||comparison of baseline mHSBP in mmHg between Telemonitoring and Enhanced Usual Care groups||||0.532
74054828|NCT02046993|147661197|SUPERIORITY_OR_OTHER|||||||0.902|||||||t-test, 2 sided|||comparison of baseline mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups||||0.902
74054829|NCT02046993|147661198|SUPERIORITY_OR_OTHER|||||||0.138|||||||t-test, 2 sided|||comparison of mHSBP at 3 months between smartphone based telemonitoring group and control group on enhanced usual care||||0.138
74054830|NCT02046993|147661198|SUPERIORITY_OR_OTHER|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups at 3 months||||0.204
74054831|NCT02046993|147661199|SUPERIORITY_OR_OTHER|||||||0.199|||||||t-test, 2 sided|||comparison of mHSBP in mmHg between Telemonitoring groups and Enhanced Usual Care groups at 6 months||||0.199
74054832|NCT02046993|147661199|SUPERIORITY_OR_OTHER|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg at 6 months between Telemonitoring and Enhanced Usual Care groups||||0.204
74054833|NCT00598442|147661201|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.101|||TWO_SIDED|97.5|-0.09|0.36|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.36|-0.09|
74054834|NCT00598442|147661201|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|97.5|0.08|0.54|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.54|0.08|
74054835|NCT00598442|147661202|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.28|||||TWO_SIDED|95.0|1.04|5.01|||Cochran-Mantel-Haenszel|||||5.01|1.04|
74054836|NCT00598442|147661202|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.1|||||TWO_SIDED|95.0|0.94|4.69|||Cochran-Mantel-Haenszel|||||4.69|0.94|
74054837|NCT00598442|147661203|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.9|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.90|
74054838|NCT00598442|147661203|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.93|1.04|||Cochran-Mantel-Haenszel|||||1.04|0.93|
74100158|NCT00580788|147749331|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05|TWO_SIDED|||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<0.05
74054839|NCT03947333|147661210|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.221|TWO_SIDED||||||t-test, 1 sided|||||||0.221
74054840|NCT03947333|147661210|OTHER||fixed-effects estimate of intervention|0.846||||0.559|TWO_SIDED|95.0|-1.99|3.68|||Mixed Models Analysis|||Mixed effects model||3.68|-1.99|0.559
74054841|NCT03947333|147661211|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.532|TWO_SIDED||||||t-test, 1 sided|||||||0.532
74054842|NCT03947333|147661212|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.086|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.086
74100159|NCT00580788|147749332|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002|TWO_SIDED|||||the reported p-value corresponds to the increase comapred to baseline over time (days 2-8) in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.002
74100160|NCT01403051|147749354|SUPERIORITY_OR_OTHER|||||||0.001||||||2-sided test with type I error rate of 5%, not adjusted for multiple comparisons.|Stratified Wilcoxon rank sum test|Stratified Wilcoxon rank sum test for differences between the two treatment groups, stratified by the screening 25-OH vitamin (\<=20 vs. \>20 ng/mL)||The study was sized to have 80% power to detect a 2 % difference in BMD of the hip from baseline to week 48.||||0.001
74100161|NCT02135614|147749375|SUPERIORITY||Treatment difference|0.12||||0.46|TWO_SIDED|95.0|-0.2|0.43||P-value was calculated from the ANCOVA model including baseline values, Clinical Frailty Scale (CFS) score, and stratification factor as covariates.|ANCOVA|||||0.43|-0.20|0.46
74054843|NCT03947333|147661212|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.562|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.562
74100162|NCT02135614|147749376|SUPERIORITY||Treatment difference|0.08||||0.046|TWO_SIDED|95.0|0.0|0.16||P-value was calculated from the ANCOVA model including the baseline value, CFS score and stratification factor as covariates.|ANCOVA|||||0.16|0.00|0.046
74100163|NCT02135614|147749377|SUPERIORITY|||||||0.39||||||P-value was calculated from the negative binomial model with the stratification factor as covariate.|Negative Binomial Model|||||||0.39
74054844|NCT03947333|147661212|OTHER||fixed-effects estimate of intervention|0.348||||0.451|TWO_SIDED|95.0|-0.557|1.254|||Mixed Models Analysis|||Mixed Effects Model||1.254|-0.557|0.451
74054845|NCT03947333|147661213|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.27|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.270
74054846|NCT03947333|147661213|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.299|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.299
74054847|NCT03947333|147661213|OTHER||fixed-effects estimate of intervention|0.1||||0.917|TWO_SIDED|95.0|-1.786|1.986|||Mixed Models Analysis|||Mixed effects model||1.986|-1.786|0.917
74100164|NCT02135614|147749378|SUPERIORITY|||||||0.004||||||P-value from the negative binomial model comparing the rate ratio between treatment groups, adjusted for the stratification factor.|Negative Binomial Model|||||||0.004
74100165|NCT01701011|147749379|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the primary outcome, anxiety. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.||||<0.05
74100166|NCT01701011|147749379|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||To test the difference in psychological well-being between three groups with a power of 95%,a ¼ 0.05 and a medium effect size ( f ¼ 0.25), a total of 297 participants were required (99 patients per group). Taking into account a 20% attrition rate, at least 124 women had to be recruited in each group.||||<0.05
74100167|NCT01701011|147749380|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the secondary outcome, depression. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.||||<0.05
74054848|NCT03947333|147661214|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.093|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.093
74054849|NCT03947333|147661214|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.034|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.034
74054850|NCT03947333|147661214|OTHER||fixed-effects estimate of intervention|0.242||||0.103|TWO_SIDED|95.0|-0.049|0.533|||Mixed Models Analysis|||Mixed Effects Model||0.533|-0.049|0.103
74054851|NCT03947333|147661215|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.116|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.116
74054852|NCT03947333|147661215|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.009|TWO_SIDED||||||t-test, 1 sided|||||||0.009
74054853|NCT03947333|147661215|OTHER||fixed-effects estimate of intervention|0.183||||0.178|TWO_SIDED|95.0|-0.084|0.451|||Mixed Models Analysis|||Mixed Effects Model||0.451|-0.084|0.178
74054854|NCT03947333|147661216|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.188|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.188
74054855|NCT03947333|147661216|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.749|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.749
74054856|NCT03947333|147661216|OTHER||fixed-effects estimate of intervention|0.031||||0.847|TWO_SIDED|95.0|-0.288|0.351|||Mixed Models Analysis|||Mixed Effects Model||0.351|-0.288|0.847
74054857|NCT03947333|147661217|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.182|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.182
74054858|NCT03947333|147661217|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.158|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.158
74054859|NCT03947333|147661217|OTHER||fixed-effects estimate of intervention|0.107||||0.612|TWO_SIDED|95.0|-0.305|0.519|||Mixed Models Analysis|||Mixed Effects Model||0.519|-0.305|0.612
74054860|NCT03947333|147661218|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.97|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.970
74054861|NCT03947333|147661218|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.786|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.786
74054862|NCT03947333|147661218|OTHER||fixed-effects estimate of intervention|-0.088||||0.67|TWO_SIDED|95.0|-0.493|0.317|||Mixed Models Analysis|||Mixed Effects Model||0.317|-0.493|0.670
74054863|NCT03947333|147661219|SUPERIORITY||Median Difference (Final Values)|0.0||||0.478|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.478
74100168|NCT02119819|147749394|SUPERIORITY||Posterior Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16||0.459|TWO_SIDED|90.0|-1.05|-0.52|||Bayesian|||||-0.52|-1.05|0.459
74054864|NCT03947333|147661219|SUPERIORITY||Mean Difference (Net)|-0.2||||0.666|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.666
74054865|NCT03947333|147661219|OTHER||fixed-effects estimate of intervention|-0.15||||0.601|TWO_SIDED|95.0|-0.713|0.413|||Mixed Models Analysis|||Mixed Effects Model||0.413|-0.713|0.601
74054866|NCT03947333|147661220|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.654|TWO_SIDED||||||t-test, 1 sided|||||||0.654
74054867|NCT03947333|147661221|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.485|TWO_SIDED||||||t-test, 1 sided|||||||0.485
74054868|NCT03947333|147661222|OTHER|||||||0.48|||||||McNemar|||||||0.480
74054869|NCT03947333|147661222|OTHER|||||||0.023|||||||McNemar|||||||0.023
74054870|NCT03947333|147661223|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.542|TWO_SIDED||||||t-test, 1 sided|||||||0.542
74054871|NCT00368069|147661229|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.155||||0.038||95.0|0.009|0.301|||ANCOVA|Analysis of covariance (ANCOVA) on (log-) POS freq/week over Treatment period with Treatment, (log-) Baseline POS freq/week as covariate.||||0.301|0.009|0.038
74054872|NCT00368069|147661229|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|14.4||||||95.0|0.9|26.0|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over PBO is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS freq/week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||26.0|0.9|
74054873|NCT00368069|147661231|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.158||||0.034||95.0|0.012|0.305|||ANCOVA|ANCOVA on (log-) seizure frequency per week over Treatment period with Treatment, (log-) Baseline seizure frequency per week as covariate.||||0.305|0.012|0.034
74054874|NCT00368069|147661231|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|14.7||||||95.0|1.2|26.3|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||26.3|1.2|
74100169|NCT02119819|147749394|SUPERIORITY||Posterior Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.16||0.511|TWO_SIDED|90.0|-1.07|-0.54|||Bayesian|||||-0.54|-1.07|0.511
74100170|NCT02119819|147749394|SUPERIORITY||Posterior Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.16||0.988|TWO_SIDED|90.0|-1.41|-0.89|||Bayesian|||||-0.89|-1.41|0.988
74054875|NCT00368069|147661232|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.07||95.0|0.95|3.55|||Regression, Logistic|Logistic regression analysis including Treatment as a factor.|Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the period (baseline or treatment period.|||3.55|0.95|0.070
74054876|NCT00368069|147661233|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0|||||Mantel Haenszel|Subjects with missing data during the Treatment period were considered in the category \<-25%.||||||0.033
74054877|NCT00368069|147661234|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.205||||0.003||95.0|0.07|0.341|||ANCOVA|ANCOVA on (log-) Treatment POS frequency per week with Treatment and (log-) Baseline POS frequency per week as covariate||||0.341|0.070|0.003
74054878|NCT00368069|147661234|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|18.6||||||95.0|6.7|28.9|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||28.9|6.7|
74054879|NCT04680273|147661243|OTHER||Geometric mean ratio|0.573|STANDARD_DEVIATION|1.11|||||||||||The geometric coefficient of variation (%) for the AUC(0-72) geometric mean ratio was 10.4%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-72) of GDC-9545 in plasma samples compared with the AUC(0-72) of total radioactivity in plasma samples.||||
74054880|NCT04680273|147661243|OTHER||Geometric mean ratio|0.752|STANDARD_DEVIATION|1.036|||||||||||The geometric coefficient of variation (%) for the AUC(0-72) geometric mean ratio was 3.5%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-72) of total radioactivity (TR) in whole blood samples compared with the AUC(0-72) of TR in plasma samples.||||
74054881|NCT04680273|147661244|OTHER||Geometric mean ratio|0.625|STANDARD_DEVIATION|1.134|||||||||||The geometric coefficient of variation (%) for the AUC(0-t) geometric mean ratio was 12.7%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-t) of GDC-9545 in plasma samples compared with the AUC(0-t) of total radioactivity in plasma samples.||||
74054882|NCT04680273|147661244|OTHER||Geometric mean ratio|0.79|STANDARD_DEVIATION|1.171|||||||||||The geometric coefficient of variation (%) for the AUC(0-t) geometric mean ratio was 15.9%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-t) of total radioactivity (TR) in whole blood samples compared with the AUC(0-t) of TR in plasma samples.||||
74054883|NCT01430559|147661288|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from analysis of covariance (ANCOVA, repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||||-0.43|-1.20|<0.0001
74100171|NCT02119819|147749394|SUPERIORITY||Posterior Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.16||0.934|TWO_SIDED|90.0|-1.3|-0.78|||Bayesian|||||-0.78|-1.30|0.934
74100172|NCT02119819|147749394|SUPERIORITY||Posterior Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.16||0.373|TWO_SIDED|90.0|0.08|0.61|||Bayesian|||||0.61|0.08|0.373
74019521|NCT00927368|147591414|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|2.0||||0.02|TWO_SIDED|95.0|-20.0|29.0||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.||29|-20|0.02
74054884|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.0103|TWO_SIDED|95.0|-0.65|-0.09||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 2)||-0.09|-0.65|0.0103
74054885|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0295|TWO_SIDED|95.0|-0.67|-0.04||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 4)||-0.04|-0.67|0.0295
74054886|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.0041|TWO_SIDED|95.0|-0.87|-0.17||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 8)||-0.17|-0.87|0.0041
74054887|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 12)||-0.43|-1.20|<0.0001
74054888|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.16||0.0369|TWO_SIDED|95.0|-0.64|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 2)||-0.02|-0.64|0.0369
74054889|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.2642|TWO_SIDED|95.0|-0.54|0.15||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 4)||0.15|-0.54|0.2642
74054890|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.014|TWO_SIDED|95.0|-0.84|-0.1||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 8)||-0.10|-0.84|0.0140
74054891|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.2||0.0009|TWO_SIDED|95.0|-1.06|-0.28||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 12)||-0.28|-1.06|0.0009
74054892|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0017|TWO_SIDED|95.0|-0.72|-0.17||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 2)||-0.17|-0.72|0.0017
74054893|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0328|TWO_SIDED|95.0|-0.66|-0.03||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 4)||-0.03|-0.66|0.0328
74100173|NCT02119819|147749394|SUPERIORITY||Posterior Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.433|TWO_SIDED|90.0|0.07|0.59|||Bayesian|||||0.59|0.07|0.433
74100174|NCT02119819|147749394|SUPERIORITY||Posterior Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.978|TWO_SIDED|90.0|-0.28|0.24|||Bayesian|||||0.24|-0.28|0.978
74100175|NCT02119819|147749394|SUPERIORITY||Posterior Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.904|TWO_SIDED|90.0|-0.17|0.35|||Bayesian|||||0.35|-0.17|0.904
74100176|NCT02045147|147749414|OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|3.82||0.463|TWO_SIDED|95.0|-4.98|10.65|||t-test, 2 sided|||||10.65|-4.98|0.463
74100177|NCT02045147|147749414|OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|3.4||0.634|TWO_SIDED|95.0|-5.23|8.49|||t-test, 2 sided|||||8.49|-5.23|0.634
74054894|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.18||0.0043|TWO_SIDED|95.0|-0.86|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 8)||-0.16|-0.86|0.0043
74100178|NCT02045147|147749414|OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.15||0.259|TWO_SIDED|95.0|-3.74|13.32|||t-test, 2 sided|||||13.32|-3.74|0.259
74100179|NCT02045147|147749414|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|2.5||0.472|TWO_SIDED|95.0|-3.21|6.84|||t-test, 2 sided|||||6.84|-3.21|0.472
74100180|NCT02045147|147749415|OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.15||0.532|TWO_SIDED|95.0|-8.5|4.5|||t-test, 2 sided|||||4.5|-8.5|0.532
73881623|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.3122|TWO_SIDED|95.0|-1.52|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.49|-1.52|0.3122
74054895|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.19|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 12)||-0.43|-1.19|<0.0001
74054896|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.13||0.0051|TWO_SIDED|95.0|-0.65|-0.12||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 2)||-0.12|-0.65|0.0051
74054897|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0593|TWO_SIDED|95.0|-0.61|0.01||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 4)||0.01|-0.61|0.0593
74054898|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0046|TWO_SIDED|95.0|-0.84|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 8)||-0.16|-0.84|0.0046
73881624|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9977|TWO_SIDED|95.0|-1.0|1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||1.00|-1.00|0.9977
74054899|NCT01430559|147661289|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.14|-0.39||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 12)||-0.39|-1.14|<0.0001
74054900|NCT01430559|147661290|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.94|-0.3||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 2)||-0.30|-0.94|0.0002
74054901|NCT01430559|147661290|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.0015|TWO_SIDED|95.0|-0.92|-0.22||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 4)||-0.22|-0.92|0.0015
74054902|NCT01430559|147661290|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19||0.0003|TWO_SIDED|95.0|-1.08|-0.32||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 8)||-0.32|-1.08|0.0003
74054903|NCT01430559|147661290|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.34|-0.51||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 12)||-0.51|-1.34|<0.0001
74054904|NCT01430559|147661290|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.0363|TWO_SIDED|95.0|-0.67|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 2)||-0.02|-0.67|0.0363
74054905|NCT01430559|147661290|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.18||0.0311|TWO_SIDED|95.0|-0.75|-0.04||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 4)||-0.04|-0.75|0.0311
74054906|NCT01430559|147661290|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.0057|TWO_SIDED|95.0|-0.94|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 8)||-0.16|-0.94|0.0057
74054907|NCT01430559|147661290|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.52|-0.64||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 12)||-0.64|-1.52|<0.0001
74054908|NCT01430559|147661292|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.2373|TWO_SIDED|95.0|0.79|2.55||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 2)||2.55|0.79|0.2373
74054909|NCT01430559|147661292|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.2069|TWO_SIDED|95.0|0.84|2.26||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 4)||2.26|0.84|0.2069
74100181|NCT02045147|147749415|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|2.9||0.574|TWO_SIDED|95.0|-7.5|4.2|||t-test, 2 sided|||||4.2|-7.5|0.574
74054910|NCT01430559|147661292|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||0.068|TWO_SIDED|95.0|0.97|2.53||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 8)||2.53|0.97|0.0680
74100182|NCT02045147|147749415|OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.254|TWO_SIDED|95.0|-12.3|3.4|||t-test, 2 sided|||||3.4|-12.3|0.254
74054911|NCT01430559|147661292|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.41||||0.0005|TWO_SIDED|95.0|1.47|3.94||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 12)||3.94|1.47|0.0005
74054912|NCT01430559|147661292|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.94||||0.1736|TWO_SIDED|95.0|0.75|5.01||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 2)||5.01|0.75|0.1736
74054913|NCT01430559|147661292|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.1496|TWO_SIDED|95.0|0.82|3.59||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 4)||3.59|0.82|0.1496
74054914|NCT01430559|147661292|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12||||0.0171|TWO_SIDED|95.0|1.14|3.93||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 8)||3.93|1.14|0.0171
74054915|NCT01430559|147661292|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.77||||0.0004|TWO_SIDED|95.0|1.57|4.89||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 12)||4.89|1.57|0.0004
74054916|NCT01430559|147661293|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.0027|TWO_SIDED|95.0|-0.31|-0.07||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 2||-0.07|-0.31|0.0027
74054917|NCT01430559|147661293|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0308|TWO_SIDED|95.0|-0.3|-0.01||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 4||-0.01|-0.30|0.0308
74054918|NCT01430559|147661293|SUPERIORITY_OR_OTHER_LEGACY|P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.31|-0.05|||ANCOVA|||Week 8||-0.05|-0.31|0.0060
74100183|NCT02045147|147749415|OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.7||0.759|TWO_SIDED|95.0|-6.3|4.6|||t-test, 2 sided|||||4.6|-6.3|0.759
74054919|NCT01430559|147661293|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.0076|TWO_SIDED|95.0|-0.34|-0.05||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 12||-0.05|-0.34|0.0076
74054920|NCT01430559|147661294|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.13||||0.2843|TWO_SIDED|95.0|0.53|8.5||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 2||8.50|0.53|0.2843
74054921|NCT01430559|147661294|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.05||||0.105|TWO_SIDED|95.0|0.86|4.87||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 4||4.87|0.86|0.1050
74054922|NCT01430559|147661294|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.7861|TWO_SIDED|95.0|0.4|3.32||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 8||3.32|0.40|0.7861
74054923|NCT01430559|147661294|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.1873|TWO_SIDED|95.0|0.77|3.78||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 12||3.78|0.77|0.1873
74100184|NCT02045147|147749416|OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|3.6||0.153|TWO_SIDED|95.0|-2.1|12.7|||t-test, 2 sided|||||12.7|-2.1|0.153
74100185|NCT02045147|147749416|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|3.3||0.729|TWO_SIDED|95.0|-7.9|5.5|||t-test, 2 sided|||||5.5|-7.9|0.729
74100186|NCT02045147|147749416|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|3.5||0.886|TWO_SIDED|95.0|-6.6|7.6|||t-test, 2 sided|||||7.6|-6.6|0.886
74100187|NCT02045147|147749416|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|3.1||0.446|TWO_SIDED|95.0|-8.7|3.9|||t-test, 2 sided|||||3.9|-8.7|0.446
74100188|NCT02045147|147749417|OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|4.1||0.521|TWO_SIDED|95.0|-5.7|11.1|||t-test, 2 sided|||||11.1|-5.7|0.521
74100189|NCT02045147|147749417|OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|2.7||0.146|TWO_SIDED|95.0|-1.5|9.5|||t-test, 2 sided|||||9.5|-1.5|0.146
73881625|NCT03192176|147297635|SUPERIORITY||LSMean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9312|TWO_SIDED|95.0|-1.05|0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.97|-1.05|0.9312
74019522|NCT00927368|147591415|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||Stimulating needle versus stimulating catheter.||||0.11
74054924|NCT01430559|147661295|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|1.55||0.3738|TWO_SIDED|95.0|-1.67|4.42||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||General health||4.42|-1.67|0.3738
74054925|NCT01430559|147661295|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.94|STANDARD_ERROR_OF_MEAN|1.96||0.0028|TWO_SIDED|95.0|2.07|9.8||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical functioning||9.80|2.07|0.0028
74054926|NCT01430559|147661295|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.16|STANDARD_ERROR_OF_MEAN|2.14||0.0002|TWO_SIDED|95.0|3.95|12.38||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Role physical||12.38|3.95|0.0002
74100190|NCT02045147|147749417|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|4.3||0.926|TWO_SIDED|95.0|-8.5|9.3|||t-test, 2 sided|||||9.3|-8.5|0.926
74100191|NCT02045147|147749417|OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|2.4||0.526|TWO_SIDED|95.0|-6.4|3.3|||t-test, 2 sided|||||3.3|-6.4|0.526
74100192|NCT02045147|147749418|OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|3.9||0.776|TWO_SIDED|95.0|-9.2|6.9|||t-test, 2 sided|||||6.9|-9.2|0.776
74100193|NCT02045147|147749418|OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|3.3||0.135|TWO_SIDED|95.0|-1.6|11.7|||t-test, 2 sided|||||11.7|-1.6|0.135
74100194|NCT02045147|147749418|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.1||0.556|TWO_SIDED|95.0|-10.9|6.0|||t-test, 2 sided|||||6.0|-10.9|0.556
74100195|NCT02045147|147749418|OTHER||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|2.7||0.361|TWO_SIDED|95.0|-2.9|7.9|||t-test, 2 sided|||||7.9|-2.9|0.361
74100196|NCT02045147|147749419|OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|4.4||0.564|TWO_SIDED|95.0|-6.4|11.6|||t-test, 2 sided|||||11.6|-6.4|0.564
74100197|NCT02045147|147749419|OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|3.1||0.307|TWO_SIDED|95.0|-3.0|9.3|||t-test, 2 sided|||||9.3|-3.0|0.307
74100198|NCT02045147|147749419|OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.8||0.768|TWO_SIDED|95.0|-6.7|8.9|||t-test, 2 sided|||||8.9|-6.7|0.768
74100199|NCT02045147|147749419|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.785|TWO_SIDED|95.0|-4.2|5.5|||t-test, 2 sided|||||5.5|-4.2|0.785
74100200|NCT02045147|147749420|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.5||0.917|TWO_SIDED|95.0|-7.5|6.8|||t-test, 2 sided|||||6.8|-7.5|0.917
74100201|NCT02045147|147749420|OTHER||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|3.3||0.181|TWO_SIDED|95.0|-2.2|11.3|||t-test, 2 sided|||||11.3|-2.2|0.181
74100202|NCT02045147|147749420|OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.6||0.772|TWO_SIDED|95.0|-6.3|8.3|||t-test, 2 sided|||||8.3|-6.3|0.772
74100203|NCT02045147|147749420|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|2.8||0.526|TWO_SIDED|95.0|-3.8|7.3|||t-test, 2 sided|||||7.3|-3.8|0.526
74100204|NCT02045147|147749421|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.42||0.872|TWO_SIDED|95.0|-0.8|0.9|||t-test, 2 sided|||||.9|-.8|0.872
74100205|NCT02045147|147749421|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.387|TWO_SIDED|95.0|-0.87|0.34|||t-test, 2 sided|||||.34|-.87|0.387
74100206|NCT02045147|147749421|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.916|TWO_SIDED|95.0|-0.37|0.81|||t-test, 2 sided|||||.81|-.37|0.916
74100207|NCT02045147|147749421|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.189|TWO_SIDED|95.0|-0.19|0.94|||t-test, 2 sided|||||.94|-.19|0.189
74100208|NCT02045147|147749422|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.627|TWO_SIDED|95.0|-0.21|0.13|||t-test, 2 sided|||||.13|-.21|0.627
74100209|NCT02045147|147749422|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.84|TWO_SIDED|95.0|-0.11|0.09|||t-test, 2 sided|||||.09|-.11|0.840
74100210|NCT02045147|147749422|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.049|TWO_SIDED|95.0|-0.22|0.0|||t-test, 2 sided|||||-.00|-.22|0.049
74100211|NCT02045147|147749422|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.952|TWO_SIDED|95.0|-0.06|0.06|||t-test, 2 sided|||||.06|-.06|0.952
74100212|NCT02045147|147749423|OTHER||Mean Difference (Final Values)|6.9||||0.436|TWO_SIDED|95.0|-11.07|25.0|||t-test, 2 sided|||||25.00|-11.07|.436
74100213|NCT02045147|147749423|OTHER||Mean Difference (Final Values)|-11.8|STANDARD_ERROR_OF_MEAN|6.71||0.088|TWO_SIDED|95.0|-25.24|1.8|||t-test, 2 sided|||||1.80|-25.24|.088
74019523|NCT00927368|147591415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.0||||0.01|TWO_SIDED|95.0|6.0|75.0|||ANOVA|||Stimulating needle versus ultrasound guidance alone||75|6|0.01
74100214|NCT02045147|147749423|OTHER||Median Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|7.45||0.169|TWO_SIDED|95.0|-25.86|4.77|||t-test, 2 sided|||||4.77|-25.86|0.169
74100215|NCT02045147|147749423|OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|4.52||0.416|TWO_SIDED|95.0|-12.79|5.37|||t-test, 2 sided|||||5.37|-12.79|0.416
74019524|NCT00927368|147591415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.0|||<|0.001|TWO_SIDED|95.0|31.0|102.0|||ANOVA|||Stimulating catheter versus ultrasound guidance alone||102|31|< 0.001
74054927|NCT01430559|147661295|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|7.36|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED|95.0|4.1|10.63||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Bodily pain||10.63|4.10|<0.0001
74054928|NCT01430559|147661295|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.05|STANDARD_ERROR_OF_MEAN|1.64||0.2124|TWO_SIDED|95.0|-1.18|5.27||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Vitality||5.27|-1.18|0.2124
74054929|NCT01430559|147661295|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.96|STANDARD_ERROR_OF_MEAN|2.1||0.005|TWO_SIDED|95.0|1.82|10.1||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Social functioning||10.10|1.82|0.0050
74054930|NCT01430559|147661295|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.87|STANDARD_ERROR_OF_MEAN|2.24||0.0093|TWO_SIDED|95.0|1.46|10.28||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Role emotional||10.28|1.46|0.0093
74054931|NCT01430559|147661295|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|1.64||0.7274|TWO_SIDED|95.0|-2.66|3.81||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Mental health||3.81|-2.66|0.7274
74054932|NCT01430559|147661295|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|0.88||0.2819|TWO_SIDED|95.0|-0.78|2.67||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Mental component aggregate||2.67|-0.78|0.2819
74054933|NCT01430559|147661295|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.57|STANDARD_ERROR_OF_MEAN|0.66||0.0001|TWO_SIDED|95.0|1.27|3.86||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical component aggregate||3.86|1.27|0.0001
74054934|NCT01430559|147661296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.6||||0.0014|TWO_SIDED|95.0|1.45|4.66||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Mobility||4.66|1.45|0.0014
74054935|NCT01430559|147661296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.108|TWO_SIDED|95.0|0.91|2.48||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Self-care||2.48|0.91|0.1080
74054936|NCT01430559|147661296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.06||||0.0119|TWO_SIDED|95.0|1.17|3.62||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Usual activities||3.62|1.17|0.0119
74054937|NCT01430559|147661296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.0887|TWO_SIDED|95.0|0.93|2.83||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Pain/discomfort||2.83|0.93|0.0887
74054938|NCT01430559|147661296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.2466|TWO_SIDED|95.0|0.8|2.33||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Anxiety/depression||2.33|0.80|0.2466
74054939|NCT01430559|147661297|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0367|TWO_SIDED|95.0|-0.58|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 2||-0.02|-0.58|0.0367
74054940|NCT01430559|147661297|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0652|TWO_SIDED|95.0|-0.65|0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 4||0.02|-0.65|0.0652
74054941|NCT01430559|147661297|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.19||0.02|TWO_SIDED|95.0|-0.81|-0.07||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 8||-0.07|-0.81|0.0200
74054942|NCT01430559|147661297|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.0016|TWO_SIDED|95.0|-1.02|-0.24||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 12||-0.24|-1.02|0.0016
74054943|NCT01177943|147661298|NON_INFERIORITY_OR_EQUIVALENCE|80-125% was used for bioequivalence (BE) criteria in terms of geometric means.|Ratio of Geometric LS Mean values|0.945|||||TWO_SIDED|90.0|0.858|1.04|||ANOVA|||||1.04|0.858|
74054944|NCT01177943|147661299|NON_INFERIORITY_OR_EQUIVALENCE|80-125% was used for bioequivalence (BE) criteria in terms of the ratio of geometric means.|Ratio of AUC(0-tlast) values|1.03|||||TWO_SIDED|90.0|1.0|1.07|||ANOVA|||||1.07|1.00|
74054945|NCT03319160|147661311|OTHER||Incidence per 100 patient-years|7.5|STANDARD_DEVIATION|2.74|||TWO_SIDED|95.0|6.3|8.7|||||"Poisson distribution assumed due to the infrequent nature of the events. Number of appropriate shock events: 19 (17 subjects had one appropriate shock event, one subject had two appropriate shock events).~Length of exposure: 253 patient-years."|||8.7|6.3|
74054946|NCT03319160|147661313|OTHER||Incidence per 100 patient-years|3.2|STANDARD_DEVIATION|1.78|||TWO_SIDED|95.0|1.9|4.4|||||||Poisson distribution assumed due to the infrequent nature of the events. Number of inappropriately shocked events: 8. Length of exposure: 253 patient-years.|4.4|1.9|
74054947|NCT04533204|147661328|SUPERIORITY||Mean Difference (Final Values)|18.47|||<|0.001|TWO_SIDED|95.0|12.28|24.67|||Mixed Models Analysis|||||24.67|12.28|<.001
74054948|NCT04533204|147661329|SUPERIORITY||Mean Difference (Final Values)|2.33||||0.004|TWO_SIDED|95.0|0.75|3.91||Performance on cued recall (error scores)|Mixed Models Analysis|||||3.91|.75|.004
74054949|NCT00329433|147661426|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||Published data show that the incidence of PF4/heparin EIA antibodies is approximately 40% (range, 20% to 60%) following cardiac surgery. We estimated that antibody formation would occur in approximately 20% of patients following thoracic surgery. Sixty patients in each group would provide 80% power to detect a decrease in the incidence of positive PF4/heparin EIA tests from 20% to 4% at an alpha level of \<0.05.||||<0.05
74054950|NCT00329433|147661427|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74054951|NCT00329433|147661428|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74054952|NCT01189201|147661429|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.9|STANDARD_DEVIATION|7.2|||TWO_SIDED|90.0|102.07|107.8|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability||107.80|102.07|
74054953|NCT01189201|147661430|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.91|STANDARD_DEVIATION|12.8|||TWO_SIDED|90.0|99.97|110.09|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||110.09|99.97|
74054954|NCT01189201|147661431|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|107.68|STANDARD_DEVIATION|15.3|||TWO_SIDED|90.0|101.7|114.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||114.02|101.70|
74054955|NCT01189201|147661432|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|109.68|STANDARD_DEVIATION|26.2|||TWO_SIDED|90.0|99.55|120.83|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||120.83|99.55|
74054956|NCT01189201|147661435|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.78|STANDARD_DEVIATION|7.1|||TWO_SIDED|90.0|102.02|107.61|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||107.61|102.02|
74054957|NCT01189201|147661436|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.64|STANDARD_DEVIATION|19.7|||TWO_SIDED|90.0|97.23|112.62|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||112.62|97.23|
74054958|NCT01189201|147661437|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.86|STANDARD_DEVIATION|9.3|||TWO_SIDED|90.0|81.33|90.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||90.64|81.33|
74054959|NCT01189201|147661438|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|61.41|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|54.1|69.71|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||69.71|54.10|
74054960|NCT01189201|147661439|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.32|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|80.77|90.14|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||90.14|80.77|
74054961|NCT01189201|147661440|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|93.18|STANDARD_DEVIATION|15.7|||TWO_SIDED|90.0|85.07|102.05|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||102.05|85.07|
74054962|NCT01189201|147661441|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|68.48|STANDARD_DEVIATION|27.2|||TWO_SIDED|90.0|58.59|80.03|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||80.03|58.59|
74054963|NCT01189201|147661442|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|90.95|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|84.24|98.19|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||98.19|84.24|
74054964|NCT01189201|147661443|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.64|STANDARD_DEVIATION|9.6|||TWO_SIDED|90.0|91.19|100.3|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.30|91.19|
74054965|NCT01189201|147661444|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|98.04|STANDARD_DEVIATION|13.0|||TWO_SIDED|90.0|91.95|104.53|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||104.53|91.95|
74054966|NCT01189201|147661445|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.69|STANDARD_DEVIATION|9.8|||TWO_SIDED|90.0|91.17|100.43|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.43|91.17|
74054967|NCT01189201|147661446|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|92.98|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|86.36|100.09|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.09|86.36|
74054968|NCT01189201|147661447|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|103.71|STANDARD_DEVIATION|22.4|||TWO_SIDED|90.0|92.93|115.74|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||115.74|92.93|
74054969|NCT01189201|147661448|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|96.36|STANDARD_DEVIATION|14.3|||TWO_SIDED|90.0|89.78|103.42|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||103.42|89.78|
74054970|NCT04308668|147661456|SUPERIORITY||Mean Difference (Net)|-2.4||||0.35|TWO_SIDED|95.0|-7.0|2.2|||Fisher Exact||Values represent percentages. Experimental treatment arm compared with the placebo control arm.|||2.2|-7.0|0.35
74054971|NCT04308668|147661457|SUPERIORITY||Mean Difference (Net)|-0.27||||0.117|TWO_SIDED|95.0|-0.61|0.27|||Mixed Models Analysis|||||0.27|-0.61|0.117
74054972|NCT01336647|147661465|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy endpoint was responder rate calculated based on the percentage of subjects who were lice free at all follow-up visits (Days 1, 7 and 14). Because the number of responders and non-responders in the family size\>= 5 household members was less than five in at least one of the treatment arms, (Table 14.2.1.5), Fisher's Exact test was used to compare treatment arms, instead of the CMH test.|||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|The assessment of statistical significance will be done using Hochberg's modified Bonferroni test.||Null hypothesis; 80% power and 0.025 two-sided level of significance for each pairwise active vs. vehicle comparison||||<0.001
74054973|NCT03808298|147661467|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|90.0|-1.99|2.9||||||||2.90|-1.99|
74054974|NCT03808298|147661467|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.73|2.24||||||||2.24|-2.73|
74054975|NCT03808298|147661467|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-2.25|2.79||||||||2.79|-2.25|
74054976|NCT03808298|147661467|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-1.94|3.09||||||||3.09|-1.94|
74054977|NCT03808298|147661467|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.62|2.35||||||||2.35|-2.62|
74054978|NCT03808298|147661467|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.6|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-0.88|4.11||||||||4.11|-0.88|
74054979|NCT03808298|147661467|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|90.0|-1.63|3.85||||||||3.85|-1.63|
74054980|NCT03808298|147661467|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|90.0|-3.13|2.79||||||||2.79|-3.13|
74054981|NCT03808298|147661467|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|90.0|-2.6|4.47||||||||4.47|-2.60|
74054982|NCT03808298|147661467|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-2.03|2.98||||||||2.98|-2.03|
74054983|NCT03808298|147661468|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|-0.19|2.64||||||||2.64|-0.19|
74054984|NCT03808298|147661468|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|-0.12|2.33||||||||2.33|-0.12|
74054985|NCT03808298|147661468|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose|LS Mean|2.0|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.4|3.67||||||||3.67|0.40|
74054986|NCT03808298|147661468|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose|LS Mean|2.5|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|0.6|4.49||||||||4.49|0.60|
74054987|NCT03808298|147661468|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose|LS Mean|2.5|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|90.0|0.09|4.94||||||||4.94|0.09|
74054988|NCT03808298|147661468|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.84|||TWO_SIDED|90.0|-1.62|4.47||||||||4.47|-1.62|
74054989|NCT03808298|147661468|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose|LS Mean|1.6|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|-0.1|3.39||||||||3.39|-0.10|
74054990|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|90.0|-0.6|2.2||||||||2.20|-0.60|
74054991|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose|LS Mean|1.3|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|0.13|2.55||||||||2.55|0.13|
74054992|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose|LS Mean|1.7|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|0.04|3.27||||||||3.27|0.04|
74019525|NCT00927368|147591416|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|14.0|||||TWO_SIDED||||||||Incremental cost (additional cost of stimulating needle compared to ultrasound alone).|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
74019526|NCT00927368|147591416|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|36.0|||||TWO_SIDED||||||||We estimated incremental cost, or additional cost of stimulating needle + catheter stimulation to stimulating needle alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
74019527|NCT00927368|147591416|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|50.0|||||TWO_SIDED||||||||We calculated incremental cost, or the additional cost of stimulating needle + stimulating catheter to ultrasound alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
74019528|NCT00964431|147591417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.545|STANDARD_ERROR_OF_MEAN|1.8912|<|0.001|TWO_SIDED|95.0|5.816|13.275|||ANCOVA|||||13.275|5.816|<0.001
74019529|NCT01482910|147591429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|||<|0.0001|TWO_SIDED|95.0|6.8|13.4||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|ANCOVA|ANCOVA with baseline BCVA as a covariate, and treatment group and baseline BCVA group (\<45 letters vs ≥45 letters) as fixed factors|Least square mean difference (EYLEA-PDT) was estimated from ANCOVA, where a positive value is in favor of EYLEA.|Null hypothesis: mean changes are identical in both groups. A sample size of 300 subjects with a 3:1 (EYLEA to PDT) randomization ratio is sufficient to detect the superiority of EYLEA to PDT assuming a two-sided alpha level of 0.05, a power of 90%, a treatment difference of 7.5 letters and a common standard deviation of 14 letters.||13.4|6.8|<0.0001
74019530|NCT01482910|147591430|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.6||||0.0359|TWO_SIDED|95.0|0.4|12.9||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|Cochran-Mantel-Haenszel|CMH adjusted for baseline BCVA group (\<45 letters vs ≥45 letters)|Proportion difference (EYLEA-PDT) was estimated from CMH, where a positive value is in favor of EYLEA.|Null hypothesis: proportions are identical in both groups||12.9|0.4|0.0359
74019531|NCT01872338|147591431|SUPERIORITY||Incident Rate Ratio|0.5||||0.015|TWO_SIDED|95.0|0.29|0.87|||negative binomial regression|||||.87|.29|.015
74019532|NCT01872338|147591432|SUPERIORITY||Incident Rate Ratio|0.43||||0.01|TWO_SIDED|95.0|0.22|0.82|||negative binomial regression|||||.82|.22|.01
74019533|NCT01872338|147591433|SUPERIORITY|||||||0.34|||||||Regression, Linear|repeated measures, overall time by condition effect||||||.34
74019534|NCT01872338|147591434|SUPERIORITY|||||||0.23||||||repeated measures, overall time by condition effect|Regression, Linear|||||||.23
74019535|NCT03683394|147591445|SUPERIORITY||Mean Difference (Net)|0.15||||0.008|TWO_SIDED|95.0|0.04|0.26||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||0.26|0.04|0.008
74019536|NCT03683394|147591446|SUPERIORITY||Mean Difference (Net)|0.11||||0.002|TWO_SIDED|95.0|0.02|0.21||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||0.21|0.02|0.002
74019537|NCT03683394|147591447|SUPERIORITY||Mean Difference (Net)|1.11||||0.03|TWO_SIDED|95.0|0.08|2.14||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||2.14|0.08|0.03
74019538|NCT03683394|147591448|SUPERIORITY||Odds Ratio (OR)|0.68||||0.52|TWO_SIDED|95.0|0.19|2.19||Adjusted for age and sex.|Fisher Exact|In an exploratory outcome, we examined incidence of a low CASI score or a diagnosis of MCI or dementia by treatment group.||||2.19|0.19|0.52
74019539|NCT00110019|147591449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.863|TWO_SIDED|95.0|0.87|1.18|||Log Rank|Stratified log rank test is used for overall survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group|||1.18|0.87|0.863
74019540|NCT00110019|147591450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.092|TWO_SIDED|95.0|0.78|1.03||priori threshold for statistical significance: P\<0.05|Log Rank|Stratified log rank test is used for progression-free survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group|||1.03|0.78|0.092
74019541|NCT00110019|147591451|SUPERIORITY_OR_OTHER|||||||0.427||95.0||||priori threshold for statistical significance: P\<0.05|Fisher Exact|||||||0.427
74019542|NCT04426695|147591456|SUPERIORITY||Least Square (LS) Mean Difference|-0.25||||0.0663|TWO_SIDED|95.0|-0.51|0.02||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||||0.02|-0.51|0.0663
74019543|NCT04426695|147591456|SUPERIORITY||Least Square (LS) Mean Difference|-0.31||||0.0204||95.0|-0.57|0.05||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||||0.05|-0.57|0.0204
73881626|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.51||0.6005|TWO_SIDED|95.0|-1.27|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.74|-1.27|0.6005
74054993|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose|LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-0.64|3.2||||||||3.20|-0.64|
74054994|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose|LS Mean|2.3|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-0.13|4.67||||||||4.67|-0.13|
74054995|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.82|||TWO_SIDED|90.0|-2.31|3.7||||||||3.70|-2.31|
74054996|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.35|2.1||||||||2.10|-1.35|
74054997|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|90.0|-2.94|1.89||||||||1.89|-2.94|
74054998|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|-3.19|1.72||||||||1.72|-3.19|
74054999|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.26|2.74||||||||2.74|-2.26|
74055000|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.02|2.96||||||||2.96|-2.02|
74055001|NCT03808298|147661469|EQUIVALENCE|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.49|||TWO_SIDED|90.0|-2.39|2.54||||||||2.54|-2.39|
74055002|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.67|4.28||||||||4.28|-0.67|
74055003|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-2.11|3.31||||||||3.31|-2.11|
73888169|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|210.4||||0.0029|TWO_SIDED|95.0|73.0|347.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||347.8|73.0|0.0029
74055004|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|-2.38|3.47||||||||3.47|-2.38|
74055005|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|-2.85|4.14||||||||4.14|-2.85|
74055006|NCT03808298|147661469|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.36|2.6||||||||2.60|-2.36|
74055007|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-1.2|0.73||||||||0.73|-1.20|
74055008|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-1.08|0.96||||||||0.96|-1.08|
74055009|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.73|0.78||||||||0.78|-1.73|
74055010|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|90.0|-1.8|0.7||||||||0.70|-1.80|
74055011|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|-2.42|1.05||||||||1.05|-2.42|
74055012|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-2.66|1.24||||||||1.24|-2.66|
74055013|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|90.0|-1.91|0.85||||||||0.85|-1.91|
74055014|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose|LS Mean|-2.2|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-3.9|-0.48||||||||-0.48|-3.90|
74055015|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-3.41|0.0||||||||0.00|-3.41|
74055016|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose|LS Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|90.0|-3.21|0.36||||||||0.36|-3.21|
74055017|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose|LS Mean|-1.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|-3.25|0.01||||||||0.01|-3.25|
74055018|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-3.36|-0.01||||||||-0.01|-3.36|
74055019|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose|LS Mean|-1.9|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-3.75|-0.14||||||||-0.14|-3.75|
74055020|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose|LS Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-3.06|0.29||||||||0.29|-3.06|
74055021|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|90.0|-3.08|1.01||||||||1.01|-3.08|
74055022|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.03|0.76||||||||0.76|-3.03|
73881627|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.51||0.5284|TWO_SIDED|95.0|-0.68|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||1.32|-0.68|0.5284
74055023|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.13|||TWO_SIDED|90.0|-2.87|0.87||||||||0.87|-2.87|
74055024|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-0.89|1.07||||||||1.07|-0.89|
74055025|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-1.21|0.86||||||||0.86|-1.21|
74100216|NCT01191944|147749451|NON_INFERIORITY_OR_EQUIVALENCE|pre-specified non-inferiority (NI) margin of -4 points|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.9192|<|0.0001||95.0|-1.047|2.566||one-sided test relative to NI margin of -4|ANCOVA|adjusted for treatment, centre and baseline|Pramipexole IR minus Pramipexole ER, Pramipexole ER non inferior to Pramipexole IR if lower limit of confidence interval (CI) for the mean difference is higher than NI margin.|The null hypothesis (H0) states that the mean change from baseline to Week 18 (or last observation carried forward \[LOCF\]) in the UPDRS II+III score for the treatment group pramipexole ER is inferior to the mean change for the treatment group pramipexole IR.||2.566|-1.047|<0.0001
74100217|NCT01191944|147749452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|2.1836||0.8261|TWO_SIDED|95.0|-4.787|3.826|||ANCOVA|||||3.826|-4.787|0.8261
74100218|NCT01191944|147749453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.3274||0.8698|TWO_SIDED|95.0|-0.699|0.592|||ANCOVA|||||0.592|-0.699|0.8698
74100219|NCT01191944|147749454|SUPERIORITY_OR_OTHER|||||||0.7902||95.0|||||Cochran-Mantel-Haenszel|||||||0.7902
74100220|NCT01191944|147749455|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.763|STANDARD_ERROR_OF_MEAN|2.7845||0.3223|TWO_SIDED|95.0|-8.255|2.729|||ANCOVA|||||2.729|-8.255|0.3223
74100221|NCT01191944|147749456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|STANDARD_ERROR_OF_MEAN|1.5581||0.0254|TWO_SIDED|95.0|0.437|6.583|||ANCOVA|||||6.583|0.437|0.0254
74100222|NCT01191944|147749457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.621|STANDARD_ERROR_OF_MEAN|2.2658||0.7843|TWO_SIDED|95.0|-3.848|5.09|||ANCOVA|||||5.090|-3.848|0.7843
74100223|NCT01191944|147749458|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|0.4901||0.4529|TWO_SIDED|95.0|-0.598|1.335|||ANCOVA|||||1.335|-0.598|0.4529
74100224|NCT01191944|147749459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.4437||0.2338|TWO_SIDED|95.0|-1.405|0.345|||ANCOVA|||||0.345|-1.405|0.2338
74100225|NCT01191944|147749460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.562|STANDARD_ERROR_OF_MEAN|0.2509||0.0263|TWO_SIDED|95.0|0.067|1.057|||ANCOVA|||||1.057|0.067|0.0263
74100226|NCT01191944|147749461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.3727||0.9337|TWO_SIDED|95.0|-0.704|0.766|||ANCOVA|||||0.766|-0.704|0.9337
74100227|NCT01191944|147749462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.0798||0.6995|TWO_SIDED|95.0|-0.127|0.188|||ANCOVA|||||0.188|-0.127|0.6995
74100228|NCT01191944|147749463|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||Cochran-Mantel-Haenszel|||||||0.3170
73888170|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|108.7||||0.1189|TWO_SIDED|95.0|-28.3|245.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||245.7|-28.3|0.1189
74055026|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|90.0|-1.71|0.83||||||||0.83|-1.71|
74055027|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.07|1.46||||||||1.46|-1.07|
74055028|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose|LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|-2.5|1.0||||||||1.00|-2.50|
74055029|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|-2.22|1.74||||||||1.74|-2.22|
74055030|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose|LS Mean|-2.2|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-3.63|-0.85||||||||-0.85|-3.63|
74055031|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-2.42|1.03||||||||1.03|-2.42|
74100229|NCT01191944|147749464|SUPERIORITY_OR_OTHER|||||||0.4756||95.0|||||Cochran-Mantel-Haenszel|||||||0.4756
74100230|NCT01191944|147749465|SUPERIORITY_OR_OTHER|||||||0.1051||95.0|||||Cochran-Mantel-Haenszel|||||||0.1051
74100231|NCT01191944|147749466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.3138||0.6237|TWO_SIDED|95.0|-0.463|0.771|||ANCOVA|||||0.771|-0.463|0.6237
74100232|NCT01191944|147749468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.628|STANDARD_ERROR_OF_MEAN|0.7088||0.376|TWO_SIDED|95.0|-0.765|2.021|||ANCOVA|||||2.021|-0.765|0.3760
74100233|NCT00603837|147749473|SUPERIORITY_OR_OTHER|||||||0.445||95.0|||||t-test, 1 sided|||||||0.445
74100234|NCT00789035|147749528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.74|-0.29||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 5mg minus placebo|||-0.29|-0.74|<0.0001
74100235|NCT00789035|147749528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.8|-0.35||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 10mg minus placebo|||-0.35|-0.80|<0.0001
74100236|NCT00789035|147749528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.94|-0.5||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 25mg minus placebo|||-0.50|-0.94|<0.0001
74055032|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline Day 14 HR (bpm) at 0.5 Hours Pre-dose|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-2.96|0.49||||||||0.49|-2.96|
74055033|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose|LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-2.58|1.02||||||||1.02|-2.58|
74100237|NCT04411914|147749598|SUPERIORITY|||||||0.0009|||||||Spearman Correlation Coefficient|||||||0.0009
74100238|NCT04411914|147749599|OTHER|||||||0.0053|||||||Spearman Correlation Coefficient|"Spearman Correlation Coefficient, N=9 Prob \> \|r\| under H0: Rho=0"||||||0.0053
74100239|NCT01778634|147749643|SUPERIORITY||Odds Ratio (OR)|7.51|||<|0.0001|TWO_SIDED|95.0|2.53|22.27|||Cochran-Mantel-Haenszel|||||22.27|2.53|<0.0001
74100240|NCT01778634|147749644|SUPERIORITY||Risk Difference (RD)|0.11||||0.28|TWO_SIDED|95.0|-0.08|0.29|||Generalized Estimating Equations||Generalized Estimating Equations with an identity link|||0.29|-0.08|0.28
74100241|NCT01778634|147749645|SUPERIORITY|P values are based on GEE to account for twins||||||0.11|||||||GEE|||||||0.11
74100242|NCT01778634|147749646|SUPERIORITY|P values are based on GEE to account for twins. The counts provided refer to to the numbers actually observed. The analysis to determine the p value accounted for the missing 11 patients using multiple imputation.||||||0.62|||||||GEE with multiple imputation|||||||0.62
74055034|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-2.34|0.95||||||||0.95|-2.34|
74055035|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.65|0.73||||||||0.73|-2.65|
74100243|NCT01778634|147749647|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74100244|NCT01778634|147749648|SUPERIORITY|||||||0.88||||||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon (Mann-Whitney)|||||||0.88
74100245|NCT01778634|147749649|SUPERIORITY||Median Difference (Final Values)|5.0||||0.94|TWO_SIDED|95.0|-15.0|26.0||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon test after multiple outputation||Bootstrap|||26|-15|0.94
74100246|NCT01778634|147749650|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
74100247|NCT01778634|147749651|SUPERIORITY||Odds Ratio (OR)|1.07||||0.88|TWO_SIDED|95.0|0.44|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.44|0.88
74100248|NCT01778634|147749652|SUPERIORITY|||||||0.18|||||||Generalized Estimating Equations|||||||0.18
74100249|NCT01778634|147749654|SUPERIORITY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
74100250|NCT01778634|147749655|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74100251|NCT01778634|147749656|SUPERIORITY|||||||0.18|||||||Generalized Estimating Equations|||||||0.18
74100252|NCT01778634|147749657|SUPERIORITY|||||||0.091|||||||Fisher Exact|||||||0.091
74100253|NCT01778634|147749658|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74100254|NCT01778634|147749659|SUPERIORITY|||||||0.33|||||||Generalized Estimating Equations|||||||0.33
74100255|NCT01778634|147749660|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74100256|NCT01651793|147749675|SUPERIORITY|||||||0.05||||||P value reference to the beverage x time interaction effect|ANCOVA|||Hypotheses were tested using a series (all outcome variables) of 2 Treatment x 4 Time point, repeated measures ANCOVAs that controlled for the prior night's sleep. Primary interests were the presence of statistically significant interactions of time and either cocoa versus placebo, cocoa + caffeine versus cocoa, or cocoa + caffeine versus caffeine-only. Significant interactions were decomposed using one-way ANOVAs and t-tests with familywise error controlled using LSD post-hoc tests.||||0.05
74100257|NCT00719615|147749684|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Only risk factors significant at the 0.10 level in univariate analysis were included in the multivariate model.|Fisher Exact|||Patient characteristics for each group were assessed using descriptive statistics, including medians, range, frequencies, and proportions. Categorical outcomes were compared between the 3 groups using a Fisher's exact test. A logistic regression modeling procedure was used to compare the odds of a low vitamin D levels between patient groups while adjusting for other risk factors: gender, age, BMI, season, and TNM staging.||||<0.05
74100258|NCT00345943|147749689|OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED||||||Mixed Models Analysis|Growth curve models with between-within degrees of freedom and a random effect for the intercept and fixed effects for predictors.|BN versus HC group effect|Growth curve models examined the following: group (BN versus HC) differences in cortical thickness (CT) at baseline; group differences in the rate of change in CT over time; and the persistence of group differences in CT over time.||||.03
74100259|NCT00345943|147749689|OTHER||Slope|0.053|STANDARD_ERROR_OF_MEAN|0.047|<|0.05|TWO_SIDED|95.0|-0.04|0.15|||Mixed Models Analysis|Growth curve models with between-within degrees of freedom and a random effect for the intercept and fixed effects for predictors.||Growth curve models examined the following: group (BN versus HC) differences in conflict-related BOLD signal at baseline; group differences in the rate of change in conflict-related BOLD signal over time; and the persistence of group differences in conflict-related BOLD signal over time.||0.15|-0.04|<.05
74100260|NCT00789737|147749697|SUPERIORITY_OR_OTHER|||||||0.0369||95.0|||||ANCOVA|||least squares mean; 80% power to detect a 0.3% change||||0.0369
74100261|NCT00789737|147749698|SUPERIORITY_OR_OTHER|||||||0.0373||95.0|||||ANCOVA|||||||0.0373
74100262|NCT00789737|147749703|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0|||||ANCOVA|||||||<0.00001
74055036|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|-3.11|0.53||||||||0.53|-3.11|
74055037|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.73|0.66||||||||0.66|-2.73|
74100263|NCT02458287|147749730|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.4|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-72.0|-54.7|||Mixed Models Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals, and p-value are from MMRM model with fixed effects for treatment groups, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction as covariates.||-54.7|-72.0|<0.001
74100264|NCT02458287|147749739|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|STANDARD_ERROR_OF_MEAN|4.53|<|0.001|TWO_SIDED|95.0|-51.9|-34.0|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-34.0|-51.9|<0.001
74100265|NCT02458287|147749740|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.7|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-45.4|-34.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-34.1|-45.4|<0.001
73881628|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.51||0.1111|TWO_SIDED|95.0|-1.82|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.19|-1.82|0.1111
74055038|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-2.77|1.37||||||||1.37|-2.77|
74055039|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-2.5|1.33||||||||1.33|-2.50|
74055040|NCT03808298|147661470|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.57|0.2||||||||0.20|-3.57|
74055041|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|90.0|-2.56|0.17||||||||0.17|-2.56|
74055042|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|90.0|-1.62|1.55||||||||1.55|-1.62|
74055043|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|90.0|-1.22|2.09||||||||2.09|-1.22|
74055044|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.04|1.33||||||||1.33|-2.04|
74055045|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-1.0|3.33||||||||3.33|-1.00|
74055046|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.56|||TWO_SIDED|90.0|-2.3|2.88||||||||2.88|-2.30|
74055047|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-3.0|0.81||||||||0.81|-3.00|
74055048|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-2.08|3.35||||||||3.35|-2.08|
74055049|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|90.0|-2.48|3.12||||||||3.12|-2.48|
74055050|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|90.0|-2.55|3.06||||||||3.06|-2.55|
74055051|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-3.17|3.12||||||||3.12|-3.17|
74100266|NCT02458287|147749740|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.7|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-32.5|-20.8|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-20.8|-32.5|<0.001
74055052|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|90.0|-2.47|3.37||||||||3.37|-2.47|
74055053|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|90.0|-3.42|2.34||||||||2.34|-3.42|
74055054|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-3.54|2.12||||||||2.12|-3.54|
74055055|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|90.0|-3.31|1.88||||||||1.88|-3.31|
74055056|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|90.0|-1.21|4.09||||||||4.09|-1.21|
74055057|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|90.0|-2.9|2.49||||||||2.49|-2.90|
74055058|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-2.0|0.77||||||||0.77|-2.00|
74055059|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|90.0|-1.71|1.5||||||||1.50|-1.71|
74055060|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.02||||90.0|-1.64|1.73||||||||1.73|-1.64|
74055061|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-2.39|1.02||||||||1.02|-2.39|
74055062|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|-1.26|3.13||||||||3.13|-1.26|
74055063|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|1.59||||90.0|-3.92|1.35||||||||1.35|-3.92|
74055064|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.96|1.89||||||||1.89|-1.96|
74055065|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|90.0|-1.34|4.13||||||||4.13|-1.34|
74055066|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.61|4.05||||||||4.05|-1.61|
74055067|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.32|4.35||||||||4.35|-1.32|
74055068|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|90.0|-3.38|2.97||||||||2.97|-3.38|
74055069|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Pre-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.78||||90.0|-3.48|2.42||||||||2.42|-3.48|
74055070|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|-1.81|4.02||||||||4.02|-1.81|
74055071|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|90.0|-1.67|4.04||||||||4.04|-1.67|
74055072|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|90.0|-1.95|3.29||||||||3.29|-1.95|
74055073|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose|LS Mean|3.3|STANDARD_ERROR_OF_MEAN|1.62|||TWO_SIDED|90.0|0.6|5.96||||||||5.96|0.60|
74055074|NCT03808298|147661471|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose|LS Mean|2.0|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-0.72|4.72||||||||4.72|-0.72|
74055075|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.29|0.07||||||||0.07|-0.29|
74055076|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.02|0.34||||||||0.34|-0.02|
74055077|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline (ms) at QRS Day 1 2.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.3|0.12||||||||0.12|-0.30|
74055078|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.26|0.18||||||||0.18|-0.26|
74055079|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.57|0.38||||||||0.38|-0.57|
74055080|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-0.65|0.56||||||||0.56|-0.65|
74055081|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.15||||90.0|-0.11|0.4||||||||0.40|-0.11|
74055082|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.34|0.74||||||||0.74|-0.34|
74055083|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.17|0.91||||||||0.91|-0.17|
74055084|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.04|1.05||||||||1.05|-0.04|
74055085|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.26|0.82||||||||0.82|-0.26|
74055086|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|32.0|||TWO_SIDED|90.0|-0.18|0.9||||||||0.90|-0.18|
74055087|NCT03808298|147661472|OTHER||LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.08|1.0||||||Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose||1.00|-0.08|
74055088|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.19|0.94||||||||0.94|-0.19|
74055089|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.33|1.1||||||||1.10|-0.33|
74055090|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|90.0|-0.5|1.06||||||||1.06|-0.50|
74055091|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.06|1.11||||||||1.11|-0.06|
74055092|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.25|0.11||||||||0.11|-0.25|
74055093|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|0.0|0.36||||||||0.36|0.00|
74055094|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 2.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.34|0.09||||||||0.09|-0.34|
74055095|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.1|0.34||||||||0.34|-0.10|
74055096|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.4|0.57||||||||0.57|-0.40|
74055097|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-0.31|0.93||||||||0.93|-0.31|
74055098|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|0.07|0.58||||||||0.58|0.07|
74055099|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.19|0.9||||||||0.90|-0.19|
74055100|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.11|0.98||||||||0.98|-0.11|
74055101|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.06|1.05||||||||1.05|-0.06|
74055102|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.27|0.82||||||||0.82|-0.27|
74055103|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.14|0.94||||||||0.94|-0.14|
74055104|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.24|0.86||||||||0.86|-0.24|
74055105|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.07|1.2||||||||1.20|0.07|
74055106|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-0.1|1.35||||||||1.35|-0.10|
74055107|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.5|1.07||||||||1.07|-0.50|
74055108|NCT03808298|147661472|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-0.14|1.04||||||||1.04|-0.14|
74055109|NCT03808298|147661494|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 0.5 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.64|4.04||||||||4.04|-1.64|
74055110|NCT03808298|147661494|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 1 Hours Post-dose|LS Mean|5.4|STANDARD_ERROR_OF_MEAN|1.93|||TWO_SIDED|90.0|2.22|8.63||||||||8.63|2.22|
74055111|NCT03808298|147661494|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 2.5 Hours Post-dose|LS Mean|8.5|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|5.81|11.28||||||||11.28|5.81|
74055112|NCT03808298|147661494|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 4 Hours Post-dose|LS Mean|8.6|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|90.0|5.86|11.34||||||||11.34|5.86|
74055113|NCT03808298|147661494|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 8 Hours Post-dose|LS Mean|8.5|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|5.43|11.61||||||||11.61|5.43|
74055114|NCT03808298|147661494|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 12 Hours Post-dose|LS Mean|6.9|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|90.0|3.76|10.0||||||||10.00|3.76|
74055115|NCT03808298|147661494|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 24 Hours Post-dose|LS Mean|6.1|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|3.58|8.62||||||||8.62|3.58|
74055116|NCT01801475|147661496|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.||||<0.05
74055117|NCT01801475|147661497|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.||||<0.05
74055118|NCT00421928|147661498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.05||95.0|-1.04|-0.33|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and pooled analysis center as factors and baseline pain intensity score as a covariate.||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.||-0.33|-1.04|<0.05
74100267|NCT02458287|147749741|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.9|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-66.2|-49.5|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-49.5|-66.2|<0.001
74055119|NCT00444028|147661510|OTHER|"The units on such analyses are generally those of slope (rise over run), with 1.000 being perfect. Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is as good as it gets."|Slope|0.909|||||TWO_SIDED|90.0|0.832|0.987||||||Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered.||0.987|0.832|
74055120|NCT02138227|147661512|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74055121|NCT02138227|147661513|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|F (2, 1574)||||||<0.01
74055122|NCT03330275|147661527|NON_INFERIORITY|A non-inferiority margin of -0.25 was used. Non-inferioirty was concluded if the lower limit of the 95% CI was above 0.25.|Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.0574|||TWO_SIDED|95.0|-0.045|0.183|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Mean difference was calculated as Test - Control 1|It was calculated that a total of 24 participants was required to show that the Test lens is non-inferior to the control 1 lens with 80% power. Sample size for this study was based on night driving only.||0.183|-0.045|
74055123|NCT03330275|147661528|NON_INFERIORITY|A non-inferiority margin of 0.1 logMAR was used. Non-inferiority was concluded if the upper limit was below 0.1.|Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.0076|||TWO_SIDED|95.0|-0.043|-0.012|||Linear Mixed Model|Kenward and Roger Method was used for the degrees of freedom.|Mean difference was calculated as Test - Control 1|||-0.012|-0.043|
74055124|NCT03330275|147661529|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|3.162|||||TWO_SIDED|95.0|0.442|22.604|||Generalized Estimating Equation||Odds ratio was calculated as Test over Control 1|||22.604|0.442|
74055125|NCT03330275|147661530|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.82|1.16|||Generalized Linear Mixed Model||Odds ratio was calculated as Test over Control1|||1.16|0.82|
73881629|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1764|TWO_SIDED|95.0|-1.16|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||0.21|-1.16|0.1764
74100268|NCT02458287|147749741|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-44.4|-27.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-27.1|-44.4|<0.001
73881630|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.35||0.0037|TWO_SIDED|95.0|-1.73|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms||-0.34|-1.73|0.0037
73881631|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.3|-0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.92|-2.30|<0.0001
73881632|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.21|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.81|-2.21|<0.0001
73888171|NCT01746901|147309539|SUPERIORITY_OR_OTHER||LS Mean Difference|153.6||||0.0284|TWO_SIDED|95.0|16.4|290.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||290.8|16.4|0.0284
74055126|NCT03330275|147661531|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|5.29|||TWO_SIDED|95.0|7.1|28.5|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control 1|||28.5|7.1|
74055127|NCT03330275|147661532|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.33|1.74|||Generalized Linear Mixed Model||Odds Ratio was calculated as Test over Control 1|||1.74|0.33|
74055128|NCT03330275|147661533|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|7.93|||TWO_SIDED|95.0|-11.4|20.7|||Linear Mixed Model|Kenward and Roger Method was used for denominator Degrees of Freedom.|Mean difference was calculated as Test - Control 1|||20.7|-11.4|
74055129|NCT02145949|147661534|OTHER|||||||0.03|||||||ANCOVA|||||||.03
74055130|NCT02145949|147661535|OTHER|||||||0.01|||||||ANCOVA|||||||.01
74055131|NCT02145949|147661536|OTHER|||||||0.04|||||||ANCOVA|||||||.04
74055132|NCT02145949|147661537|OTHER|||||||0.01|||||||ANCOVA|||||||.01
74055133|NCT02145949|147661538|OTHER|||||||0.12|||||||ANCOVA|||||||.12
74055134|NCT02145949|147661539|OTHER|||||||0.03|||||||ANCOVA|||||||.03
74055135|NCT02145949|147661540|OTHER|||||||0.71|||||||ANCOVA|||||||.71
74055136|NCT02145949|147661541|OTHER|||||||0.76|||||||ANCOVA|||||||.76
74055137|NCT02145949|147661542|OTHER|||||||0.4|||||||ANCOVA|||||||.40
74055138|NCT02145949|147661543|OTHER|||||||0.97|||||||ANCOVA|||||||.97
74055139|NCT02145949|147661544|OTHER|||||||0.89|||||||ANCOVA|||||||.89
74055140|NCT02145949|147661545|OTHER|||||||0.48|||||||ANCOVA|||||||.48
74055141|NCT02145949|147661546|OTHER|||||||0.02|||||||ANCOVA|||||||.02
74055142|NCT02145949|147661547|OTHER|||||||0.29|||||||ANCOVA|||||||.29
74055143|NCT02145949|147661548|OTHER|||||||0.33|||||||ANCOVA|||||||.33
74055144|NCT02145949|147661549|OTHER|||||||0.3|||||||ANCOVA|||||||.30
74055145|NCT02145949|147661550|OTHER|||||||0.98|||||||ANCOVA|||||||.98
74055146|NCT02145949|147661551|OTHER|||||||0.18|||||||ANCOVA|||||||.18
74055147|NCT02145949|147661552|OTHER|||||||0.52|||||||ANCOVA|||||||.52
74055148|NCT02145949|147661553|OTHER|||||||0.81|||||||ANCOVA|||||||.81
74055149|NCT00224952|147661555|OTHER|||||||0.004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (4-Methylthio-2-hydroxyiminostilbene) as a function of age||||0.004
74055150|NCT00224952|147661555|OTHER|||||||0.032|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (4-Methylthio-2-hydroxyiminostilbene) as a function of age||||0.032
74055151|NCT00224952|147661555|OTHER|||||||0.018|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Fractional Recovery (MTHIS)) as a function of age||||0.018
74055152|NCT00224952|147661555|OTHER|||||||0.033|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery MTHIS)) as a function of age||||0.033
74055153|NCT00224952|147661555|OTHER|||||||0.0004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-3-ene VPA isomers)) as a function of age||||0.0004
74055154|NCT00224952|147661555|OTHER|||||||0.0003|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-2-ene VPA) ) as a function of age||||0.0003
74055155|NCT00224952|147661555|OTHER||||||<|0.0001|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Total N-acetylcysteine conjugates) as a function of age||||<0.0001
74055156|NCT00224952|147661555|OTHER|||||||0.522|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-3-ene VPA isomers)) as a function of age||||0.522
74055157|NCT00224952|147661555|OTHER|||||||0.925|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-2-ene VPA) ) as a function of age||||0.925
74055158|NCT00224952|147661555|OTHER|||||||0.469|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery Total NAC conjugates) as a function of age||||0.469
74055159|NCT01928758|147661556|OTHER||Mean Difference (Final Values)|-175.7|||<|0.0001|TWO_SIDED|95.0|-218.3|-133.1||Complete case analysis|Regression, Linear|Model was adjusted for baseline cotinine after smoking usual nicotine content cigarettes for 2-weeks.|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.|||-133.1|-218.3|<0.0001
74055160|NCT01928758|147661557|OTHER||Mean Difference (Final Values)|0.69||||0.16|TWO_SIDED|95.0|-0.28|1.65||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group|||1.65|-0.28|0.16
74055161|NCT01928758|147661558|OTHER||Mean Difference (Final Values)|0.38||||0.67|TWO_SIDED|95.0|-1.4|2.16||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.|||2.16|-1.40|0.67
74055162|NCT01928758|147661559|OTHER||Mean Difference (Final Values)|-0.31||||0.65|TWO_SIDED|95.0|-1.68|1.05||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group|||1.05|-1.68|0.65
74055163|NCT02452320|147661571|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
74055164|NCT01072175|147661584|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.79|1.34|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for dabrafenib were calculated.|||1.34|0.79|
74055165|NCT01072175|147661584|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.78|1.25|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2285403 were calculated.|||1.25|0.78|
74055166|NCT01072175|147661584|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.84|1.27|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2298683 were calculated.|||1.27|0.84|
74055167|NCT01072175|147661584|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.66|1.45|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2167542 were calculated.|||1.45|0.66|
74100269|NCT02458287|147749742|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.2|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-63.7|-48.6|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-48.6|-63.7|<0.001
74100270|NCT02458287|147749742|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.2|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-45.0|-29.3|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-29.3|-45.0|<0.001
74100271|NCT03968978|147749748|OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.67|99.5|||Score CI|CI at Week 0 (in clinic)||||99.5|93.67|
74055168|NCT01072175|147661585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.85|1.19|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.|||1.19|0.85|
74055169|NCT01072175|147661585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-inf) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.82|1.08|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.|||1.08|0.82|
74055170|NCT01072175|147661585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.84|1.25|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2285403 were calculated.|||1.25|0.84|
74055171|NCT01072175|147661585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-inf) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.81|1.03|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for GSK2285403 were calculated.|||1.03|0.81|
74100272|NCT03968978|147749748|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.65|100.0|||Score CI|CI at Week 4 (in clinic)||||100|96.65|
74100273|NCT03968978|147749748|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 8 (in clinic)||||100.00|96.63|
74100274|NCT03968978|147749748|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 12 (at home)||||100.00|96.63|
74100275|NCT03968978|147749748|OTHER||Proportion|95.4|||||TWO_SIDED|95.0|89.71|98.02|||Score CI|CI for Week 16 (at home)||||98.02|89.71|
74100276|NCT03968978|147749748|OTHER||Proportion|96.3|||||TWO_SIDED|95.0|90.94|98.56|||Score CI|CI for Week 20 (in clinic)||||98.56|90.94|
74055172|NCT01072175|147661585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.81|1.29|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2298683 were calculated.|||1.29|0.81|
74055173|NCT01072175|147661585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.76|1.37|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2167542 were calculated.|||1.37|0.76|
74055174|NCT01072175|147661592|SUPERIORITY_OR_OTHER||Unconditional exact method|-4.0|||||TWO_SIDED|95.0|-23.1|15.9||||||Difference in response rate Arm2 - Arm1||15.9|-23.1|
74055175|NCT01072175|147661592|SUPERIORITY_OR_OTHER||Unconditional exact method|22.0|||||TWO_SIDED|95.0|2.5|40.7||||||Difference in response rate Arm3 - Arm1||40.7|2.5|
74055176|NCT01072175|147661593|SUPERIORITY_OR_OTHER||Unconditional exact method|-6.0|||||TWO_SIDED|95.0|-24.9|14.1||||||Difference in response rate Arm2- Arm1||14.1|-24.9|
74055177|NCT01072175|147661593|SUPERIORITY_OR_OTHER||Unconditional exact method|15.0|||||TWO_SIDED|95.0|-4.9|33.7||||||Difference in response rate Arm3 - Arm1||33.7|-4.9|
74055178|NCT01072175|147661594|SUPERIORITY_OR_OTHER||Response rate|6.0|||||TWO_SIDED|95.0|5.1|26.8||||||||26.8|5.1|
74055179|NCT01072175|147661595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0048|TWO_SIDED|95.0|0.38|0.87|||Log Rank||HRs were estimated using the Pike estimator.|||0.87|0.38|0.0048
74055180|NCT01072175|147661595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Log Rank||HRs were estimated using the Pike estimator.|||0.68|0.29|<0.0001
74100277|NCT03968978|147749748|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.47|100.0|||Score CI|CI for Week 0 (in clinic)||||100.00|96.47|
74100278|NCT03968978|147749748|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 4 (in clinic)||||99.02|91.93|
74055181|NCT01072175|147661597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1667|TWO_SIDED|95.0|0.45|1.18|||Log Rank||HRs were estimated using the Pike estimator.|||1.18|0.45|0.1667
74055182|NCT01072175|147661597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0119|TWO_SIDED|95.0|0.32|0.9|||Log Rank||HRs were estimated using the Pike estimator.|||0.90|0.32|0.0119
74055183|NCT01072175|147661605|NON_INFERIORITY_OR_EQUIVALENCE|Following loge tranformation, Cmax of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.51|||||TWO_SIDED|90.0|1.1|2.08|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|||2.08|1.10|
74055184|NCT01072175|147661607|NON_INFERIORITY_OR_EQUIVALENCE|Following loge transformation, AUC(0-tau) of dabrafenib was analyzed by a linear mixed effect model with dosing chort and day as fixed effects and subject as random effect. Based on the model, geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.|Geometric Mean Ratio|1.23|||||TWO_SIDED|90.0|0.89|1.69|||||Geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.|||1.69|0.89|
74055185|NCT01072175|147661607|NON_INFERIORITY_OR_EQUIVALENCE|Following loge tranformation, AUC(0-tau) of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5, 2 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were then provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.1|||||TWO_SIDED|90.0|0.84|1.44|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|||1.44|0.84|
74055186|NCT00351611|147661667|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI bound was less than 0.10 (10%).|Difference in percentage of participants|-1.7094|||||TWO_SIDED|95.0|-9.1751|5.9784||||||A 2-sided 95 percent (%) confidence interval (CI) on the difference in percentage of participants, between pregabalin and placebo was constructed using unconditional exact methods.||5.9784|-9.1751|
74055187|NCT00351611|147661668|NON_INFERIORITY|Non-inferiority with respect to mean deviation was demonstrated if the lower bound of the CI is greater than -2.0 decibels.|Difference in LS mean|-0.125||||0.4414|TWO_SIDED|95.0|-0.443|0.194|||ANCOVA|||Analysis of covariance (ANCOVA) with treatment and center in the model and the baseline mean deviation as the covariate was used to construct a 2-sided 95% CI on the difference in least squares (LS) mean between pregabalin and placebo.||0.194|-0.443|0.4414
74100279|NCT03968978|147749748|OTHER||Proportion|98.1|||||TWO_SIDED|95.0|93.32|99.48|||Score CI|CI for Week 8 (in clinic)||||99.48|93.32|
74055188|NCT00351611|147661669|OTHER||Difference in LS mean|-0.9||||0.1346|TWO_SIDED|95.0|-2.083|0.283|||ANCOVA|||ANCOVA with treatment and center in the model and the baseline visual acuity as the covariate was used to construct a 2-sided 95% confidence interval on the difference in LS mean between pregabalin and placebo.||0.283|-2.083|0.1346
74055189|NCT00808665|147661670|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
74055190|NCT02347345|147661683|OTHER|Descriptive pilot study. Not relevant.||||||0.07|||||||Kruskal-Wallis|||||||0.07
74055191|NCT02735382|147661704|SUPERIORITY||Odds Ratio (OR)|4.663|||<|0.0001|TWO_SIDED|95.0|4.116|5.283|||Chi-squared, Corrected|||||5.283|4.116|<.0001
74055192|NCT02735382|147661705|SUPERIORITY||Odds Ratio (OR)|3.284|||<|0.0001|TWO_SIDED|95.0|2.672|4.035|||Chi-squared, Corrected|||||4.035|2.672|<.0001
74100280|NCT03968978|147749748|OTHER||Proportion|99.0|||||TWO_SIDED|95.0|94.8|99.83|||Score CI|CI for week 12 (at home)||||99.83|94.80|
74100281|NCT03968978|147749748|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 16 (at home)||||99.02|91.93|
74100282|NCT03968978|147749748|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 20 (in clinic)||||99.02|91.93|
74100283|NCT03968978|147749749|OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.67|99.5|||Score CI|CI at Week 0 (in clinic)||||99.50|93.67|
73881633|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1444|TWO_SIDED|95.0|-1.21|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||0.18|-1.21|0.1444
74055193|NCT02735382|147661706|SUPERIORITY||Odds Ratio (OR)|0.885||||0.8438|TWO_SIDED|95.0|0.42|1.698|||Chi-squared, Corrected|||||1.698|0.420|.8438
74055194|NCT02735382|147661707|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.161||0.007|TWO_SIDED|95.0|0.123|0.757|||t-test, 2 sided|df=292||A change score from baseline to 6-months was computed and served as the data to be analyzed in the t-test of group differences.||0.757|0.123|.007
74100284|NCT03968978|147749749|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.65|100.0|||Score CI|CI at Week 4 (in clinic)||||100.00|96.65|
74100285|NCT03968978|147749749|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 8 (in clinic)||||100.00|96.63|
74100286|NCT03968978|147749749|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 12 (at home)||||100.00|96.63|
74100287|NCT03968978|147749749|OTHER||Proportion|97.2|||||TWO_SIDED|95.0|92.8|99.04|||Score CI|CI for Week 16 (at home)||||99.04|92.80|
74100288|NCT03968978|147749749|OTHER||Proportion|99.1|||||TWO_SIDED|95.0|94.85|99.83|||Score CI|CI for Week 20 (in clinic)||||99.83|94.85|
74100289|NCT03968978|147749749|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.46|100.0|||Score CI|CI for Week 0 (in clinic)||||100.00|96.46|
74100290|NCT03968978|147749749|OTHER||Proportion|97.2|||||TWO_SIDED|95.0|93.38|99.48|||Score CI|CI for Week 4 (in clinic)||||99.48|93.38|
74100291|NCT03968978|147749749|OTHER||Proportion|98.1|||||TWO_SIDED|95.0|93.32|99.48|||Other CI|CI for Week 8 (in clinic)||||99.48|93.32|
74100292|NCT03968978|147749749|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.44|100.0|||Score CI|CI for week 12 (at home)||||100.00|96.44|
74055195|NCT01288911|147661708|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.34|0.57|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS based on ICR Enzalutamide Vs. Bicalutamide. The (unstratified) log-rank test with an overall significance level of 0.05 (two-sided) was used to compare the PFS of enzalutamide to bicalutamide. The (unstratified) Cox proportional hazards model was used to estimate the hazard ratio of enzalutamide to bicalutamide, calculate the corresponding two-sided 95% confidence intervals and test the hypothesis that the hazard ratio is equal to 1.||0.57|0.34|<0.0001
74055196|NCT01288911|147661709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.33|0.55|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS on based investigator assessment Enzalutamide Vs. Bicalutamide.||0.55|0.33|<0.0001
74100293|NCT03968978|147749749|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.37|100.0|||Score CI|CI for Week 16 (at home)||||100.00|96.37|
73888172|NCT01746901|147309540|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0327|TWO_SIDED|95.0|-3.4|-0.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.1|-3.4|0.0327
74055197|NCT01288911|147661710|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon rank sum test|||PSA Response Enzalutamide Vs. Bicalutamide.||||<0.0001
74055198|NCT01288911|147661711|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon rank sum test|||Best PSA Response Enzalutamide Vs. Bicalutamide.||||<0.0001
74100294|NCT03968978|147749749|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.37|100.0|||Score CI|CI for Week 20 (in clinic)||||100.00|96.37|
74100295|NCT03968978|147749750|OTHER||Proportion|1.8|||||TWO_SIDED|95.0|0.5|6.33|||Score CI|CI at Week 0 (in clinic)||||6.33|0.50|
74100296|NCT03968978|147749750|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.35|||Score CI|CI at Week 4 (in clinic)||||3.35|0|
74100297|NCT03968978|147749750|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.37|||Score CI|CI for Week 8 (in clinic)||||3.37|0|
74100298|NCT03968978|147749750|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.37|||Score CI|CI for Week 12 (at home)||||3.37|0|
74100299|NCT03968978|147749750|OTHER||Proportion|2.8|||||TWO_SIDED|95.0|0.96|7.92|||Score CI|CI for Week 16 (at home)||||7.92|0.96|
74100300|NCT03968978|147749750|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.17|5.15|||Score CI|CI for Week 20 (in clinic)||||5.15|0.17|
74100301|NCT03968978|147749750|SUPERIORITY||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.53|||Score CI|CI for Week 0 (in clinic)||||3.53|0|
74100302|NCT03968978|147749750|OTHER||Proportion|2.8|||||TWO_SIDED|95.0|0.97|7.99|||Score CI|CI for Week 4 (in clinic)||||7.99|0.97|
74100303|NCT03968978|147749750|OTHER||Proportion|1.9|||||TWO_SIDED|95.0|0.52|6.68|||Other CI|CI for Week 8 (in clinic)||||6.68|0.52|
74100304|NCT03968978|147749750|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.56|||Score CI|CI for week 12 (at home)||||3.56|0|
74100305|NCT03968978|147749750|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.63|||Score CI|CI for Week 16 (at home)||||3.63|0|
74100306|NCT03968978|147749750|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.63|||Score CI|CI for Week 20 (in clinic)||||3.63|0|
74100307|NCT04614246|147749818|OTHER||LS-Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|80.0|-2.13|-1.14|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.14|-2.13|
74100308|NCT04614246|147749818|OTHER||LS-Mean|-2.13|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|80.0|-2.66|-1.61|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.61|-2.66|
74100309|NCT04614246|147749818|OTHER||LS-Mean|-1.96|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|80.0|-2.48|-1.43|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.43|-2.48|
74100310|NCT04614246|147749818|OTHER||LS-Mean|-1.94|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|80.0|-2.44|-1.45|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.45|-2.44|
74100311|NCT04614246|147749819|OTHER|mixed model repeated measures|Difference of least square-mean|0.29|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.77|1.35||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||1.35|-0.77|
73881634|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.35||0.0088|TWO_SIDED|95.0|-1.6|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.23|-1.60|0.0088
74055199|NCT01288911|147661712|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.2|0.39|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA progression Enzalutamide Vs. Bicalutamide.||0.39|0.20|<0.0001
74055200|NCT01288911|147661713|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.07|||<|0.0001|TWO_SIDED|95.0|3.18|8.09|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA Enzalutamide Vs. Bicalutamide.||8.09|3.18|<0.0001
74055201|NCT01288911|147661714|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.55|||<|0.0001|TWO_SIDED|95.0|3.96|7.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 30% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||7.79|3.96|<0.0001
74055202|NCT01288911|147661715|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|7.01|||<|0.0001|TWO_SIDED|95.0|4.83|10.16|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 50% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||10.16|4.83|<0.0001
74055203|NCT01288911|147661716|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|13.91|||<|0.0001|TWO_SIDED|95.0|7.23|26.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 90% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||26.79|7.23|<0.0001
74055204|NCT01288911|147661717|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0002|TWO_SIDED|95.0|0.36|0.74|||Log Rank||Estimated by use of Cox proportional hazards model.|Radiographic PFS based on ICR Enzalutamide Vs. Bicalutamide.||0.74|0.36|0.0002
74055205|NCT02543918|147661730|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the ixekizumab arm to the control arm for the tetanus vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|90.0|-16.6|19.2||||||Tetanus vaccine responders||19.2|-16.6|
74055206|NCT02543918|147661730|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the ixekizumab arm to the control arm for the pneumococcal vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|90.0|-12.9|11.0||||||Pneumococcal vaccine responders||11.0|-12.9|
74055207|NCT05489146|147661731|SUPERIORITY|||||||0.046|||||||Mixed Models Analysis|||||||0.046
74055208|NCT05489146|147661732|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||0.003
74055209|NCT05489146|147661733|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
74055210|NCT05489146|147661734|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
74055211|NCT05489146|147661735|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
74055212|NCT05489146|147661736|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
74055213|NCT05489146|147661737|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74055214|NCT05489146|147661738|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
74055215|NCT00078715|147661757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.004|STANDARD_ERROR_OF_MEAN|1.141||0.527|TWO_SIDED|95.0|-4.26|2.251||The significance level reflects the direct comparison of drugs after factoring out baseline depression levels.|Mixed Models Analysis|A linear mixed model was used with factors for drug, time of evaluation, the drug by time interaction, and a baseline depression covariate.||The hypothesis was that yohimbine would provide lower levels of depression than placebo. Initial estimates of sample size assumed a minimum of 25 patients were required to detect differences in depression.||2.251|-4.260|.527
74055216|NCT00643851|147661780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.1243|<|0.0001|TWO_SIDED|95.0|-1.11|-0.62||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET was superior to both controls.|ANCOVA|||||-0.62|-1.11|<0.0001
74055217|NCT00643851|147661780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1245|<|0.0001|TWO_SIDED|95.0|-0.94|-0.45||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.45|-0.94|<0.0001
73888173|NCT01746901|147309540|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.0019|TWO_SIDED|95.0|1.0|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.2|1.0|0.0019
74055218|NCT00643851|147661781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.1|STANDARD_ERROR_OF_MEAN|3.883|<|0.0001|TWO_SIDED|95.0|-26.7|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-11.4|-26.7|<0.0001
74055219|NCT00643851|147661781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.5|STANDARD_ERROR_OF_MEAN|3.897|<|0.0001|TWO_SIDED|95.0|-35.1|-19.8||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-19.8|-35.1|<0.0001
74055220|NCT00643851|147661782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.9|STANDARD_ERROR_OF_MEAN|4.633|<|0.0001|TWO_SIDED|95.0|20.8|39.0||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|modified logistic regression|||||39.0|20.8|<0.0001
74055221|NCT00643851|147661782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|4.947||0.0003|TWO_SIDED|95.0|8.1|27.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||27.4|8.1|0.0003
74055222|NCT00643851|147661783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.1938|<|0.0001|TWO_SIDED|95.0|-1.72|-0.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.96|-1.72|<0.0001
74055223|NCT00643851|147661783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|0.1912|<|0.0001|TWO_SIDED|95.0|-1.57|-0.82||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.82|-1.57|<0.0001
74055224|NCT00643851|147661784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.3388||0.8769|TWO_SIDED|95.0|-0.72|0.61||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||0.61|-0.72|0.8769
74055225|NCT00643851|147661784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3399|<|0.0001|TWO_SIDED|95.0|-2.04|-0.71||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.71|-2.04|<0.0001
74055226|NCT00643851|147661785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.4191|||TWO_SIDED|95.0|-0.98|0.66||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||0.66|-0.98|
74055227|NCT00643851|147661785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.4201|||TWO_SIDED|95.0|-2.4|-0.74||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.74|-2.40|
74055228|NCT04557189|147661790|SUPERIORITY||Adjusted Treatment Difference|0.241|||||TWO_SIDED|95.0|0.031|0.452|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.452|0.031|
74055229|NCT04557189|147661791|SUPERIORITY||Adjusted Treatment Difference|0.175|||||TWO_SIDED|95.0|-0.044|0.394|||||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on Cochran-Mantel-Haenszel (CMH) method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|0.394|-0.044|
74055230|NCT04557189|147661792|SUPERIORITY||Adjusted Treatment Difference|-0.094|||||TWO_SIDED|95.0|-0.253|0.059|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.059|-0.253|
73881635|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.35||0.0005|TWO_SIDED|95.0|-1.93|-0.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.54|-1.93|0.0005
73888174|NCT01746901|147309540|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7508|TWO_SIDED|95.0|-1.9|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.9|0.7508
74055231|NCT04557189|147661793|SUPERIORITY||Adjusted Treatment Difference|-0.141|||||TWO_SIDED|95.0|-0.316|0.033|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.033|-0.316|
74055232|NCT04557189|147661794|SUPERIORITY||Adjusted Treatment Difference|0.191|||||TWO_SIDED|95.0|-0.029|0.41|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.410|-0.029|
74055233|NCT04557189|147661795|SUPERIORITY||Adjusted Treatment Difference|0.146|||||TWO_SIDED|95.0|-0.073|0.365|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.365|-0.073|
74055234|NCT04557189|147661796|SUPERIORITY||Adjusted Treatment Difference|-0.234|||||TWO_SIDED|95.0|-0.448|-0.019|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||-0.019|-0.448|
74055235|NCT04557189|147661797|SUPERIORITY||Hazard Ratio (HR)|0.393|||||TWO_SIDED|95.0|0.122|1.259|||||The hazard ratio is derived from a Cox proportional hazard model with treatment group and the number of Apfel risk factors (3 or 4) as independent variables.|||1.259|0.122|
74055236|NCT04557189|147661798|SUPERIORITY||Difference in LSM Estimates|0.188|||||TWO_SIDED|95.0|-0.402|0.777||||||30 Minutes Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.777|-0.402|
74055237|NCT04557189|147661798|SUPERIORITY||Difference in LSM Estimates|0.401|||||TWO_SIDED|95.0|-0.258|1.059||||||1 Hour Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|1.059|-0.258|
74055238|NCT04557189|147661798|SUPERIORITY||Difference in LSM Estimates|0.265|||||TWO_SIDED|95.0|0.0|0.786||||||2 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.786|0|
74055239|NCT04557189|147661798|SUPERIORITY||Difference in LSM Estimates|0.097|||||TWO_SIDED|95.0|-0.093|0.286||||||6 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.286|-0.093|
74055240|NCT04557189|147661798|SUPERIORITY||Difference in LSM Estimates|-0.203|||||TWO_SIDED|95.0|-0.575|0.17||||||24 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.170|-0.575|
74055241|NCT04557189|147661799|SUPERIORITY||Adjusted Treatment Difference|0.146|||||TWO_SIDED|95.0|-0.073|0.365|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.365|-0.073|
74055242|NCT01731600|147661818|OTHER||Incidence rate|0.0|||||ONE_SIDED|97.5||0.067|||||The incidence of inhibitory antibodies was calculated as number of patients with inhibitors during the main phase of the trial divided by number of patients in the main phase of the trial.|A one-sided, upper 97.5% confidence limit was provided based on an exact calculation in the binomial distribution.||0.067||
74055243|NCT00465894|147661835|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||.45
74055244|NCT01728454|147662024|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.0360
74055245|NCT01728454|147662024|SUPERIORITY|||||||0.1087|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1087
74055246|NCT01728454|147662024|SUPERIORITY|||||||0.2263|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.2263
74055247|NCT01728454|147662024|SUPERIORITY|||||||0.5375|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.5375
74055248|NCT01728454|147662025|SUPERIORITY|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1017
74055249|NCT01728454|147662025|SUPERIORITY|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1927
74055250|NCT01728454|147662025|SUPERIORITY|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.1017
74055251|NCT01728454|147662025|SUPERIORITY|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.1927
74100312|NCT04614246|147749819|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-1.27|0.91||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.91|-1.27|
74100313|NCT04614246|147749819|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.08|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|98.0|-1.17|1.02||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||1.02|-1.17|
74019544|NCT04426695|147591456|SUPERIORITY||Least Square (LS) Mean Difference|-0.28||||0.0172|TWO_SIDED|95.0|-0.51|-0.05||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||-0.05|-0.51|0.0172
74055252|NCT01728454|147662026|SUPERIORITY|||||||0.7508|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.7508
74055253|NCT01728454|147662026|SUPERIORITY|||||||0.5507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.5507
74055254|NCT01728454|147662026|SUPERIORITY|||||||0.3993|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.3993
74055255|NCT01728454|147662026|SUPERIORITY|||||||0.5821|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.5821
74055256|NCT01728454|147662027|SUPERIORITY|||||||0.7507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.7507
74055257|NCT01728454|147662027|SUPERIORITY|||||||0.8919|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.8919
74055258|NCT01728454|147662028|SUPERIORITY|||||||0.478|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.4780
74055259|NCT01728454|147662028|SUPERIORITY|||||||0.2354|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.2354
74055260|NCT01728454|147662029|SUPERIORITY|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1140
74055261|NCT01728454|147662029|SUPERIORITY|||||||0.1636|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1636
74055262|NCT01728454|147662030|SUPERIORITY|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1140
74055263|NCT01728454|147662030|SUPERIORITY|||||||0.0733|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.0733
74055264|NCT01728454|147662031|SUPERIORITY|||||||0.1253|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1253
74055265|NCT01728454|147662031|SUPERIORITY|||||||0.3442|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.3442
74055266|NCT01728454|147662032|SUPERIORITY|||||||0.0303|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.0303
74055267|NCT01728454|147662032|SUPERIORITY|||||||0.2864|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.2864
74055268|NCT01728454|147662033|SUPERIORITY|||||||0.4365|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1||||0.4365
74055269|NCT01728454|147662033|SUPERIORITY|||||||0.1302|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1||||0.1302
74055270|NCT01728454|147662033|SUPERIORITY|||||||0.3591|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1||||0.3591
74055271|NCT01728454|147662033|SUPERIORITY|||||||0.0872|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1||||0.0872
74055272|NCT01728454|147662033|SUPERIORITY|||||||0.4814|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1||||0.4814
74055273|NCT01728454|147662033|SUPERIORITY|||||||0.9162|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1||||0.9162
74055274|NCT01728454|147662033|SUPERIORITY|||||||0.6607|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1||||0.6607
74055275|NCT01728454|147662033|SUPERIORITY|||||||0.9527|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1||||0.9527
74055276|NCT01728454|147662034|SUPERIORITY|||||||0.2812|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1||||0.2812
74055277|NCT01728454|147662034|SUPERIORITY|||||||0.5858|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1||||0.5858
74055278|NCT01728454|147662034|SUPERIORITY|||||||0.4116|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1||||0.4116
74055279|NCT01728454|147662034|SUPERIORITY|||||||0.4252|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1||||0.4252
74055280|NCT01728454|147662035|SUPERIORITY|||||||0.6131|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1||||0.6131
74055281|NCT01728454|147662035|SUPERIORITY|||||||0.7881|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1||||0.7881
74100314|NCT04614246|147749819|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|0.29|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|80.0|-0.4|0.98||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.98|-0.4|
74055282|NCT01728454|147662035|SUPERIORITY|||||||0.9376|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1||||0.9376
74055283|NCT01728454|147662035|SUPERIORITY|||||||0.6552|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1||||0.6552
74055284|NCT01728454|147662035|SUPERIORITY|||||||0.7143|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1||||0.7143
74055285|NCT01728454|147662035|SUPERIORITY|||||||0.2985|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1||||0.2985
74055286|NCT01728454|147662035|SUPERIORITY|||||||0.3162|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1||||0.3162
74055287|NCT01728454|147662035|SUPERIORITY|||||||0.7503|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1||||0.7503
74100315|NCT04614246|147749819|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|80.0|-0.89|0.53||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.53|-0.89|
74100316|NCT04614246|147749819|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.08|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|80.0|-0.79|0.64||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.64|-0.79|
74100317|NCT00070499|147749868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0|||||Fisher Exact|||||||0.073
74100318|NCT00070499|147749868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Fisher Exact|||||||0.31
74100319|NCT00070499|147749870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0|||||Log Rank|||Log-rank test of overall survival||||0.29
74055288|NCT01190839|147662036|SUPERIORITY_OR_OTHER|||||||0.097||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||0.097
74055289|NCT01190839|147662037|SUPERIORITY_OR_OTHER||||||<|0.001||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||<0.001
74055290|NCT01190839|147662038|SUPERIORITY_OR_OTHER|||||||0.098||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||0.098
74055291|NCT01362062|147662082|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 3.||||=0.001
74055292|NCT01362062|147662082|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 4.||||=0.001
74055293|NCT01362062|147662082|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 5.||||=0.001
74100320|NCT00070499|147749870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||Log Rank|||Log-rank test of overall survival||||0.55
74100321|NCT00070499|147749871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074||95.0|||||Log Rank|||Log-rank test of relapse-free survival||||0.074
74100322|NCT00070499|147749871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0|||||Log Rank|||Log-rank test of relapse-free survival||||0.29
74100323|NCT02883049|147749873|SUPERIORITY||Hazard Ratio (HR)|1.022||||0.893|TWO_SIDED|95.0|0.74|1.413|||Log Rank||Hazard ratio = hazard rate for Arm B/hazard rate for Arm A|To compare the DFS of the randomized patients on HR B-ALL Arm A vs Arm B. With a total of 1800 patients accrued over 5 years with minimum follow up of 2 years, randomized 1:1 to the 2 arms, we will be able to detect an improvement in 5-year DFS from 90% to 94 (HR=0.5873) between IT MTX and ITT based regimens (2-sided log rank test, alpha=5%), with 84.2% power.||1.413|0.74|0.893
74100324|NCT02883049|147749874|SUPERIORITY||Hazard Ratio (HR)|1.019||||0.556|ONE_SIDED|97.5||1.335|||Log Rank||Hazard ratio = hazard rate for Experimental Arm 1 /hazard rate for Control Arm|To compare the DFS of the randomized patients on Control Arm vs. Experimental Arm 1. This study design will have 86.8% power (1-sided log rank test, adjusted alpha=0.025 for multiple comparisons) to detect an improvement in 4-year DFS from 70% to 79% (HR=0.661) between the control arm and the experimental arm.||1.335||0.556
74055294|NCT01362062|147662082|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 6.||||=0.001
74055295|NCT01362062|147662082|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 7.||||=0.001
74055296|NCT01362062|147662082|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 8.||||=0.001
74055297|NCT01362062|147662082|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 9.||||=0.001
74055298|NCT01362062|147662082|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 10.||||=0.001
74100325|NCT01392963|147749911|OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74100326|NCT00369486|147749913|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||Adjusted for baseline central subfield thickness|repeated measures least sq. regression|Models adjusted for baseline values and for correlated data from subjects with two study eyes.||Comparison of change in central subfield thickening from baseline to 34 weeks in all five groups.||||0.46
74055299|NCT01362062|147662082|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 11.||||=0.001
74055300|NCT01362062|147662082|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 12.||||=0.001
74055301|NCT01362062|147662082|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 13.||||=0.001
74055302|NCT01362062|147662083|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 3.||||=0.003
74055303|NCT01362062|147662083|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 4.||||=0.005
74055304|NCT01362062|147662083|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 5.||||=0.002
74055305|NCT01362062|147662083|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 6.||||=0.014
74055306|NCT01362062|147662083|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 7.||||=0.001
74055307|NCT01362062|147662083|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 8.||||=0.008
74055308|NCT01362062|147662083|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 9.||||=0.014
74055309|NCT01362062|147662083|SUPERIORITY_OR_OTHER||||||=|0.009|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 10.||||=0.009
74055310|NCT01362062|147662083|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 11.||||=0.001
74055311|NCT01362062|147662083|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 12.||||=0.001
74055312|NCT01362062|147662083|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 13.||||=0.001
74055313|NCT01362062|147662084|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.002
74055314|NCT01362062|147662084|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
74055315|NCT01362062|147662084|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.002
74055316|NCT01362062|147662084|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
74055317|NCT01362062|147662084|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
74055318|NCT01362062|147662084|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
74055319|NCT01362062|147662084|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
74055320|NCT01362062|147662084|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
74055321|NCT01362062|147662084|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
74055322|NCT01362062|147662084|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
74055323|NCT01362062|147662084|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
74055324|NCT01362062|147662085|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.001
74055325|NCT01362062|147662085|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
74055326|NCT01362062|147662085|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.001
74055327|NCT01362062|147662085|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
74055328|NCT01362062|147662085|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
74055329|NCT01362062|147662085|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
74055330|NCT01362062|147662085|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
74055331|NCT01362062|147662085|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
74055332|NCT01362062|147662085|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
74055333|NCT01362062|147662085|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
74055334|NCT01362062|147662085|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
74055335|NCT01362062|147662086|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.001
74055336|NCT01362062|147662086|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
74055337|NCT01362062|147662086|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.001
74055338|NCT01362062|147662086|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
74055339|NCT01362062|147662086|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
74055340|NCT01362062|147662086|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
74055341|NCT01362062|147662086|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
74055342|NCT01362062|147662086|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
74055343|NCT01362062|147662086|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
74055344|NCT01362062|147662086|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
74019545|NCT04426695|147591457|SUPERIORITY|||||||0.0431||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0431
74055345|NCT01362062|147662086|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
74019546|NCT04426695|147591457|SUPERIORITY|||||||0.7975||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.7975
74019547|NCT04426695|147591457|SUPERIORITY|||||||0.2048||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.2048
74019548|NCT04426695|147591458|SUPERIORITY|||||||0.0039||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0039
74019549|NCT04426695|147591458|SUPERIORITY|||||||0.2415||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2415
74019550|NCT04426695|147591458|SUPERIORITY|||||||0.0195||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0195
74019551|NCT04426695|147591459|SUPERIORITY|||||||0.0085||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0085
74019552|NCT04426695|147591459|SUPERIORITY|||||||0.9902||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.9902
74019553|NCT04426695|147591459|SUPERIORITY|||||||0.1486||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.1486
74019554|NCT04426695|147591460|SUPERIORITY|||||||0.0092||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0092
74019555|NCT04426695|147591460|SUPERIORITY|||||||0.221||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2210
74019556|NCT04426695|147591460|SUPERIORITY|||||||0.0249||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0249
74019557|NCT04426695|147591461|SUPERIORITY|||||||0.0045||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0045
74019558|NCT04426695|147591461|SUPERIORITY|||||||0.0714||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0714
74019559|NCT04426695|147591461|SUPERIORITY|||||||0.0061||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0061
74019560|NCT04426695|147591462|SUPERIORITY|||||||0.0023||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0023
74019561|NCT04426695|147591462|SUPERIORITY|||||||0.3544||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3544
74019562|NCT04426695|147591462|SUPERIORITY|||||||0.0212||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0212
74019563|NCT04426695|147591468|SUPERIORITY|||||||0.0575||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0575
74055346|NCT01362062|147662087|SUPERIORITY_OR_OTHER||||||=|0.064|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.064
74055347|NCT01362062|147662087|SUPERIORITY_OR_OTHER||||||=|0.104|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.104
74055348|NCT01362062|147662087|SUPERIORITY_OR_OTHER||||||=|0.052|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.052
74055349|NCT01362062|147662087|SUPERIORITY_OR_OTHER||||||=|0.043|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.043
74055350|NCT01362062|147662087|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB of Visit 7.||||=0.015
74055351|NCT01362062|147662087|SUPERIORITY_OR_OTHER||||||=|0.023|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.023
74055352|NCT01362062|147662087|SUPERIORITY_OR_OTHER||||||=|0.028|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.028
74055353|NCT01362062|147662087|SUPERIORITY_OR_OTHER||||||=|0.048|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.048
74100327|NCT00369486|147749914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.04||95.0|0.2|1.0|||generalized estimating equations|||Analysis combined posterior and anterior injection + laser groups to compare with laser only.||1.0|0.2|0.04
74055354|NCT01362062|147662087|SUPERIORITY_OR_OTHER||||||=|0.025|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.025
74055355|NCT01362062|147662087|SUPERIORITY_OR_OTHER||||||=|0.023|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.023
74055356|NCT01362062|147662087|SUPERIORITY_OR_OTHER||||||=|0.022|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.022
74055357|NCT02545504|147662095|SUPERIORITY||Cox Proportional Hazard|0.93||||0.5625|TWO_SIDED|95.0|0.74|1.18||The significance level at final analysis is 0.046 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by Eastern Cooperative Oncology Group (ECOG) status, geographic region and primary tumor site.|Hazard ratio (HR) was stratified by ECOG status, geographic region and primary tumor site with treatment arm as the only covariate.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint.||1.18|0.74|0.5625
74055358|NCT02545504|147662096|SUPERIORITY||Cox Proportional Hazard|0.84||||0.1031|TWO_SIDED|95.0|0.67|1.04||The significance level at final analysis was 0.032 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by ECOG status,geographic region and primary tumor site.|HR was stratified by ECOG status,geographic region;primary tumor site with treatment arm as a covariate.Stratum with \<6 participants or no informative event by combined treatment arms was pooled with smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. PFS was tested only if OS was significant. The P-value is for display only.||1.04|0.67|0.1031
74055359|NCT02545504|147662097|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0493|TWO_SIDED|95.0|1.0|2.15||The significance level at final analysis was 0.032 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Cochran-Mantel-Haenszel|p-value was stratified by ECOG status, geographic region and primary tumor site.|OR was stratified by ECOG status, geographic region and primary tumor site. Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.The P-value is for display only.||2.15|1.00|0.0493
74055360|NCT02545504|147662097|SUPERIORITY||ORR Difference|9.4|||||TWO_SIDED|95.0|0.1|18.8|||||The 2-sided 95% confidence interval (CI) of difference for ORR between the treatment and placebo is calculated based on stratum-adjusted Cochran-Mantel-Haenszel proportion.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.||18.8|0.1|
74055361|NCT00950755|147662115|SUPERIORITY_OR_OTHER||percentage of participants|76.0|||||TWO_SIDED|95.0|62.0|89.0|||||The estimated value represents the percentage of participants with response.|||89|62|
74055362|NCT00950755|147662116|SUPERIORITY_OR_OTHER||percentage of participants|54.0|||||TWO_SIDED|95.0|38.0|69.0|||||The estimated value represents the percentage of participants with confirmed response.|||69|38|
74055363|NCT00950755|147662117|SUPERIORITY_OR_OTHER||percentage of participants|34.0|||||TWO_SIDED|95.0|20.0|49.0|||||The estimated value represents the percentage of participants with confirmed CR.|||49|20|
74055364|NCT00950755|147662118|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||||TWO_SIDED|95.0|26.0|57.0|||||The estimated value represents the percentage of participants with confirmed CR + CCR.|||57|26|
74055365|NCT00950755|147662119|SUPERIORITY_OR_OTHER||percentage of participants|10.0|||||TWO_SIDED|95.0|1.0|19.0|||||The estimated value represents the percentage of participants with confirmed PR.|||19|1|
74055366|NCT02549040|147662136|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.85|1.09||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.09|0.85|
74055367|NCT02549040|147662136|OTHER||Geometric mean ratio|1.13|||||TWO_SIDED|90.0|1.02|1.26||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.26|1.02|
74055368|NCT02549040|147662136|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.88|1.11||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.11|0.88|
74055369|NCT02549040|147662136|OTHER||Geometric mean ratio|0.89|||||TWO_SIDED|90.0|0.8|0.99||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.99|0.80|
74100328|NCT00369486|147749914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.63||95.0|0.5|2.9|||generalized estimating equations|||Analysis combined posterior and anterior injection only groups to compare with laser only treatment group.||2.9|0.5|0.63
74055370|NCT02549040|147662137|OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.79|0.98||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.98|0.79|
74055371|NCT02549040|147662137|OTHER||Geometric mean ratio|1.09|||||TWO_SIDED|90.0|0.98|1.21||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.21|0.98|
74055372|NCT02549040|147662137|OTHER||Geometric mean ratio|0.9|||||TWO_SIDED|90.0|0.81|1.0||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.00|0.81|
74055373|NCT02549040|147662137|OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.79|0.97||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.97|0.79|
74055374|NCT02549040|147662138|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|90.0|0.61|0.82||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.82|0.61|
74055375|NCT02549040|147662138|OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.75|1.01||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.01|0.75|
74055376|NCT02549040|147662138|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|90.0|0.6|0.81||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.81|0.60|
74055377|NCT02549040|147662138|OTHER||Geometric mean ratio|0.76|||||TWO_SIDED|90.0|0.66|0.86||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.86|0.66|
74055378|NCT02549040|147662139|OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|90.0|0.72|0.93||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.93|0.72|
74055379|NCT02549040|147662139|OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.94|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.18|0.94|
74055380|NCT02549040|147662139|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.96||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.96|0.76|
74055381|NCT02549040|147662139|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.74|0.94||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.94|0.74|
74055382|NCT02549040|147662142|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.75|0.94||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.94|0.75|
74055383|NCT02549040|147662142|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|0.95|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.18|0.95|
74055384|NCT02549040|147662142|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.95||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.95|0.76|
74055385|NCT02549040|147662142|OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.77|0.96||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.96|0.77|
74055386|NCT01266967|147662146|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||<|0.0001|TWO_SIDED|95.0|29.3|52.6|||Exact Test||The estimated value represents the percentage of participants with OIR.|||52.6|29.3|<0.0001
74055387|NCT01266967|147662146|SUPERIORITY_OR_OTHER||percentage of participants|37.0|||<|0.0001|TWO_SIDED|95.0|25.3|49.8|||Exact Test||The estimated value represents the percentage of participants with OIR.|||49.8|25.3|<0.0001
74055388|NCT03159455|147662192|OTHER||Slope|2.2305|STANDARD_ERROR_OF_MEAN|0.2592|||TWO_SIDED|95.0|1.6955|2.7655|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC0-24 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.7655|1.6955|
74055389|NCT03159455|147662193|OTHER||Slope|1.9007|STANDARD_ERROR_OF_MEAN|0.2382|||TWO_SIDED|95.0|1.4102|2.3912|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.3912|1.4102|
74055390|NCT03159455|147662194|OTHER||Slope|3.244|STANDARD_ERROR_OF_MEAN|0.1771|||TWO_SIDED|95.0|2.8793|3.6087|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing on Day 28 (after multiple doses). Dose proportionality of tablets for AUC0-24,28 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|3.6087|2.8793|
74055391|NCT03159455|147662195|OTHER||Slope|2.0711|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|1.7663|2.376|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing on Day 28 (after multiple doses). Dose proportionality of tablets for Cmax,28 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.3760|1.7663|
74055392|NCT05040295|147662197|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|102.5|||||TWO_SIDED|90.0|94.21|111.51|||||Reference = Treatment A Test = Treatment B Ratio=Test/Reference|AUCinf was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||111.51|94.21|
74055393|NCT05040295|147662197|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|106.65|||||TWO_SIDED|90.0|100.07|113.66|||||Reference = Treatment A Test = Treatment C Ratio=Test/Reference|AUCinf was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||113.66|100.07|
74055394|NCT05040295|147662198|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|101.12|||||TWO_SIDED|90.0|88.25|115.87|||||Reference = Treatment A Test = Treatment B Ratio=Test/Reference|Cmax was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||115.87|88.25|
74055395|NCT05040295|147662198|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|90.11|||||TWO_SIDED|90.0|78.49|103.44|||||Reference = Treatment A Test = Treatment C Ratio=Test/Reference|Cmax was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||103.44|78.49|
74055396|NCT00953849|147662201|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
74055397|NCT00953849|147662202|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
74055398|NCT00953849|147662203|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
74055399|NCT00953849|147662204|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
74055400|NCT05056311|147662214|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
74055401|NCT05056311|147662215|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
74055402|NCT05056311|147662216|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
74055403|NCT05056311|147662218|SUPERIORITY|||||||0.0001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.0001
74055404|NCT05056311|147662219|SUPERIORITY|||||||0.6374||||||The a priori threshold for statistical significance was \<0.05.|McNemar|||||||0.6374
74055405|NCT02713490|147662233|SUPERIORITY||LSMD|-26.884||||0.0381|TWO_SIDED|95.0|-56.608|2.841|||ANOVA|||||2.841|-56.608|0.0381
74055406|NCT02713490|147662234|SUPERIORITY||LSM treatment ratio|0.203||||0.0029|TWO_SIDED|95.0|0.065|0.631|||ANOVA|||||0.631|0.065|0.0029
74055407|NCT02713490|147662235|SUPERIORITY||Treatment difference|0.098||||0.0088|TWO_SIDED|95.0|0.0284|0.1685|||Cochran-Mantel-Haenszel|||||0.1685|0.0284|0.0088
74055408|NCT02713490|147662236|SUPERIORITY|||||||0.023|||||||Log Rank|||Analysis applies to the overall distribution of time to first opioid rescue, estimated from Kaplan-Meier analysis.||||0.0230
74055409|NCT02713490|147662237|SUPERIORITY|||||||0.4285|||||||Kruskal-Wallis|||||||0.4285
74055410|NCT00346775|147662240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.517|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||||0.3|-0.6|0.517
74055411|NCT03799198|147662243|SUPERIORITY||Treatment Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-5.51|-1.5|||ANCOVA|||Analysis of in-trial data with missing observations for body weight at month 12 imputed from the WMP arm based on a jump to reference multiple (x=100) imputation approach. Percent change in body weight from baseline to month 12 was calculated for each study participant within the FAS and analyzed using an analysis of covariance model with randomized treatment as a factor and baseline body weight (kg) as a covariate.||-1.50|-5.51|<0.001
74055412|NCT00960869|147662259|SUPERIORITY_OR_OTHER||proportions|2.7||||0.005|TWO_SIDED|95.0|1.1|5.5|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.||5.5|1.1|0.005
74055413|NCT00960869|147662260|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
74055414|NCT00960869|147662261|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
74055415|NCT00960869|147662262|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
74055416|NCT00960869|147662263|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
74055417|NCT01714726|147662266|SUPERIORITY||Risk Difference (RD)|22.5|||=|0.01|TWO_SIDED|90.0|8.3|36.8|||Regression, Logistic|||||36.8|8.3|=0.01
74019564|NCT04426695|147591468|SUPERIORITY|||||||0.3133||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3133
74019565|NCT04426695|147591468|SUPERIORITY|||||||0.0849||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0849
74019566|NCT04426695|147591469|SUPERIORITY|||||||0.2167||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2167
74019567|NCT04426695|147591469|SUPERIORITY|||||||0.4123||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.4123
74019568|NCT04426695|147591469|SUPERIORITY|||||||0.2206||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2206
74019569|NCT04426695|147591470|SUPERIORITY|||||||0.0383||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0383
74019570|NCT04426695|147591470|SUPERIORITY|||||||0.3296||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3296
74019571|NCT04426695|147591470|SUPERIORITY|||||||0.0766||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0766
74019572|NCT04426695|147591471|SUPERIORITY|||||||0.007||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0070
74019573|NCT04426695|147591471|SUPERIORITY|||||||0.0507||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0507
74019574|NCT04426695|147591471|SUPERIORITY|||||||0.0051||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0051
74019575|NCT04426695|147591472|SUPERIORITY|||||||0.0174||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0174
74019576|NCT04426695|147591472|SUPERIORITY|||||||0.29||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2900
74019577|NCT04426695|147591472|SUPERIORITY|||||||0.0454||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0454
74019578|NCT04426695|147591473|SUPERIORITY|||||||0.004||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0040
74019579|NCT04426695|147591473|SUPERIORITY|||||||0.0413||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0413
74019580|NCT04426695|147591473|SUPERIORITY|||||||0.0032||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0032
74019581|NCT04426695|147591474|SUPERIORITY|||||||0.0105||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0105
74019582|NCT04426695|147591474|SUPERIORITY|||||||0.0622||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0622
74019583|NCT04426695|147591474|SUPERIORITY|||||||0.0088||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0088
74055418|NCT00665366|147662314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04||||0.058|TWO_SIDED|95.0|-4.14|0.07|||ANCOVA|||||0.07|-4.14|0.058
74055419|NCT00665366|147662315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.669|TWO_SIDED|95.0|-0.16|0.25|||ANOVA/ANCOVA||Week 3|||0.25|-0.16|0.669
74055420|NCT00665366|147662315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.436|TWO_SIDED|95.0|-0.36|0.16|||ANOVA/ANCOVA||Week 6|||0.16|-0.36|0.436
74055421|NCT00665366|147662315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.053|TWO_SIDED|95.0|-0.56|0.0|||ANOVA/ANCOVA||Week 9|||0.00|-0.56|0.053
74055422|NCT00665366|147662315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.044|TWO_SIDED|95.0|-0.59|-0.01|||ANOVA/ANCOVA||Week 12|||-0.01|-0.59|0.044
74055423|NCT00665366|147662316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.24|TWO_SIDED|95.0|-0.22|0.06|||ANOVA/ANCOVA model||Week 3|||0.06|-0.22|0.240
74055424|NCT00665366|147662316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.843|TWO_SIDED|95.0|-0.15|0.19|||ANOVA/ANCOVA model||Week 6|||0.19|-0.15|0.843
74055425|NCT00665366|147662316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.117|TWO_SIDED|95.0|-0.04|0.35|||ANOVA/ANCOVA model||Week 9|||0.35|-0.04|0.117
74055426|NCT00665366|147662316|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.17||||0.109|TWO_SIDED|95.0|-0.04|0.38|||ANOVA/ANCOVA model|Week 12||||0.38|-0.04|0.109
74055427|NCT00665366|147662317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.567|TWO_SIDED|95.0|-0.37|0.2|||ANOVA/ANCOVA model|Week 12||||0.20|-0.37|0.567
74055428|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.566|TWO_SIDED|95.0|-1.66|3.03|||ANCOVA||Total score: Week 3|||3.03|-1.66|0.566
74055429|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66||||0.221||95.0|-1.0|4.32|||ANCOVA||Total score: Week 6|||4.32|-1.00|0.221
74055430|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||0.315|TWO_SIDED|95.0|-1.4|4.35|||ANCOVA||Total score: Week 9|||4.35|-1.40|0.315
74055431|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||0.212|TWO_SIDED|95.0|-1.08|4.84|||ANCOVA||Total score: Week 12|||4.84|-1.08|0.212
74055432|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.49|0.48|||ANCOVA||Autonomy score: Week 3|||0.48|-0.49|0.991
74055433|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.201|TWO_SIDED|95.0|-0.18|0.85|||ANCOVA||Autonomy score: Week 6|||0.85|-0.18|0.201
74055434|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.198|TWO_SIDED|95.0|-0.19|0.93|||ANCOVA||Autonomy score: Week 9|||0.93|-0.19|0.198
74055435|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.178|TWO_SIDED|95.0|-0.18|0.96|||ANCOVA||Autonomy score: Week 12|||0.96|-0.18|0.178
74055436|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.311|TWO_SIDED|95.0|-1.01|0.32|||ANCOVA||Occupational functioning score: Week 3|||0.32|-1.01|0.311
74055437|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.671|TWO_SIDED|95.0|-0.94|0.61|||ANCOVA||Occupational functioning score: Week 6|||0.61|-0.94|0.671
74055438|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.968|TWO_SIDED|95.0|-0.83|0.79|||ANCOVA||Occupational functioning score: Week 9|||0.79|-0.83|0.968
74055439|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.546|TWO_SIDED|95.0|-0.56|1.07|||ANCOVA||Occupational functioning score: Week 12|||1.07|-0.56|0.546
74055440|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.284|TWO_SIDED|95.0|-0.28|0.96|||ANCOVA||Cognitive functioning score: Week 3|||0.96|-0.28|0.284
74055441|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.063|TWO_SIDED|95.0|-0.04|1.35|||ANCOVA||Cognitive functioning score: Week 6|||1.35|-0.04|0.063
74055442|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.09|TWO_SIDED|95.0|-0.1|1.34|||ANCOVA||Cognitive functioning score: Week 9|||1.34|-0.10|0.090
74055443|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.072|TWO_SIDED|95.0|-0.06|1.42|||ANCOVA||Cognitive functioning score: Week 12|||1.42|-0.06|0.072
74055444|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.499|TWO_SIDED|95.0|-0.45|0.93|||ANCOVA||Interpersonal relationships score: Week 3|||0.93|-0.45|0.499
74055445|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.457|TWO_SIDED|95.0|-0.48|1.06|||ANCOVA||Interpersonal relationships score: Week 6|||1.06|-0.48|0.457
74055446|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.525||95.0|-0.56|1.1|||ANCOVA||Interpersonal relationships score: Week 9|||1.10|-0.56|0.525
74055447|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.544|TWO_SIDED|95.0|-0.58|1.09|||ANCOVA||Interpersonal relationships score: Week 12|||1.09|-0.58|0.544
74055448|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.149|TWO_SIDED|95.0|-0.08|0.52|||ANCOVA||Leisure time score: Week 3|||0.52|-0.08|0.149
74055449|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.264|TWO_SIDED|95.0|-0.15|0.54|||ANCOVA||Leisure time score: Week 6|||0.54|-0.15|0.264
74055450|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-0.35|0.35|||ANCOVA||Leisure time score: Week 9|||0.35|-0.35|0.988
74055451|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.641|TWO_SIDED|95.0|-0.27|0.44|||ANCOVA||Leisure time score: Week 12|||0.44|-0.27|0.641
74055452|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.068|TWO_SIDED|95.0|-0.02|0.61|||ANCOVA||Financial issues score: Week 3|||0.61|-0.02|0.068
74055453|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.019|TWO_SIDED|95.0|0.07|0.74|||ANCOVA||Financial issues score: Week 6|||0.74|0.07|0.019
74055454|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.136|TWO_SIDED|95.0|-0.08|0.6|||ANCOVA||Financial issues score: Week 9|||0.60|-0.08|0.136
74055455|NCT00665366|147662318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.18||95.0|-0.11|0.57|||ANCOVA||Financial issues score: Week 12|||0.57|-0.11|0.18
74055456|NCT00665366|147662319|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.466|TWO_SIDED|95.0|0.81|1.59|||Ration of response||Week 3|||1.59|0.81|0.466
74055457|NCT00665366|147662319|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.54|TWO_SIDED|95.0|0.86|1.32|||Risk ratio||Week 6|||1.32|0.86|0.540
74055458|NCT00665366|147662319|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.06|TWO_SIDED|95.0|0.99|1.38|||Risk ratio||Week 9|||1.38|0.99|0.060
74100329|NCT00369486|147749915|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||repeated measures least sq. regression|Adjusted for baseline values and for the correlated data from subjects with two study eyes.||Comparison of the mean change in visual acuity letter score among the five groups at 34 weeks. Negative changes represent a worsening in visual acuity.||||0.94
74100330|NCT02856802|147749981|NON_INFERIORITY|Assumption that 15% of placebo and 42% of DFN 02 10 mg (treated) subjects would be pain-free at 2 hours. A sample size of 50 subjects in each DB1 dosing arm provided 86% power to detect this assumed difference between placebo and DFN-02 10 mg at a 5% (2-sided) level of significance.|Odds Ratio (OR)|2.68||||0.044|TWO_SIDED|95.0|1.05|6.83|||Fisher Exact|||Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the statistical analysis system (SAS)® software package (version 9.3).||6.83|1.05|0.044
74100331|NCT02856802|147749982|NON_INFERIORITY|Non-inferiority conducted as specified in the statistical analysis plan (SAP).||||||0.007||||||The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups.|Fisher Exact|||||||0.007
74100332|NCT02856802|147749983|NON_INFERIORITY|No assumptions made.|Odds Ratio (OR)|1.31||||0.642|TWO_SIDED|95.0|0.52|3.3|||Fisher Exact|||Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the SAS® software package (version 9.3).||3.30|0.52|0.642
74100333|NCT03092219|147749984|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0|||||Fisher Exact|For this outcome measure, missing data were imputed using a LOCF (Last Observation Carried Forward) method.||||||0.0001
74055459|NCT00665366|147662319|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.289|TWO_SIDED|95.0|0.94|1.23|||Risk ratio|||||1.23|0.94|0.289
74055460|NCT00665366|147662320|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.909|TWO_SIDED|95.0|0.75|1.39|||Risk ratio (RR)||Week 3|||1.39|0.75|0.909
74055461|NCT00665366|147662320|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.573|TWO_SIDED|95.0|0.86|1.3|||RR||Week 6|||1.30|0.86|0.573
74055462|NCT00665366|147662320|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.08|TWO_SIDED|95.0|0.98|1.36|||RR||Week 9|||1.36|0.98|0.080
74055463|NCT00665366|147662320|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.211|TWO_SIDED|95.0|0.95|1.27|||RR||Week 12|||1.27|0.95|0.211
74055464|NCT00665366|147662321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68|||||TWO_SIDED|95.0|0.07|1.29|||ANOVA/ANCOVA model||Week 6|||1.29|0.07|
74055465|NCT00665366|147662321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.031|TWO_SIDED|95.0|0.08|1.58|||ANOVA/ANCOVA model||Week 12|||1.58|0.08|0.031
74055466|NCT00665366|147662321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.104|TWO_SIDED|95.0|-0.13|1.34|||ANOVA/ANCOVA model||Week 12 (LOCF)|||1.34|-0.13|0.104
74100334|NCT00459355|147750031|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||MANCOVA|||||||<0.0001
74100335|NCT00459355|147750032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||MANCOVA|||||||<.0001
74055467|NCT00665366|147662322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.21|0.32|||ANCOVA||Week 3|||0.32|-0.21|
74100336|NCT00459355|147750033|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||MANCOVA|||||||.002
74055468|NCT00665366|147662322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.05|0.53|||ANCOVA||Week 6|||0.53|-0.05|
74055469|NCT00665366|147662322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.197|TWO_SIDED|95.0|-0.11|0.54|||ANCOVA||Week 12|||0.54|-0.11|0.197
74055470|NCT00665366|147662322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.111|TWO_SIDED|95.0|-0.07|0.63|||ANCOVA||Week 12 (LOCF)|||0.63|-0.07|0.111
74055471|NCT00665366|147662323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.983|TWO_SIDED|95.0|-0.63|0.64|||ANOVA/ANCOVA model||Week 12 LOCF|||0.64|-0.63|0.983
74055472|NCT00665366|147662324|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|0.57|3.71|||Risk Ratio|Weight gain||||3.71|0.57|
74055473|NCT00665366|147662325|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.582||95.0|||||ANCOVA|||||||0.582
74055474|NCT01008059|147662343|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
74055475|NCT02322866|147662360|SUPERIORITY||Least Squares Mean Difference|-4.4|||<|0.0001|TWO_SIDED|95.0|-5.8|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|||-2.9|-5.8|< 0.0001
74055476|NCT02322866|147662361|SUPERIORITY||Treatment Rate Difference|7.3||||0.0038|TWO_SIDED|95.0|2.53|12.07||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo|||12.07|2.53|0.0038
74055477|NCT02322866|147662362|SUPERIORITY||Least Squares Mean Difference|-14.4|||<|0.0001|TWO_SIDED|95.0|-19.4|-9.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||-9.5|-19.4|< 0.0001
74055478|NCT02322866|147662363|SUPERIORITY||Least Squares Mean Difference|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.3|-7.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||-7.9|-17.3|< 0.0001
74019584|NCT04426695|147591475|SUPERIORITY|||||||0.0275||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0275
74055479|NCT02322866|147662364|SUPERIORITY||Least Squares Mean Difference|-11.8|||<|0.0001|TWO_SIDED|95.0|-16.1|-7.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||-7.5|-16.1|< 0.0001
74055480|NCT02322866|147662365|SUPERIORITY||Least Squares Mean Difference|-9.4|||<|0.0001|TWO_SIDED|95.0|-13.5|-5.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||-5.3|-13.5|< 0.0001
74055481|NCT02322866|147662366|SUPERIORITY||Least Squares Mean Difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.2|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-2.5|-5.2|< 0.0001
74055482|NCT02322866|147662367|SUPERIORITY||Least Squares Mean Difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-2.4|-5.0|< 0.0001
74055483|NCT02322866|147662368|SUPERIORITY||Least Squares Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.1|-1.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||-1.7|-4.1|< 0.0001
74055484|NCT06045026|147662378|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
74055485|NCT06045026|147662378|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
74055486|NCT06045026|147662378|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
74055487|NCT06045026|147662378|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
74055488|NCT06045026|147662378|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
74055489|NCT06045026|147662378|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
74055490|NCT06045026|147662379|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
74019585|NCT04426695|147591475|SUPERIORITY|||||||0.0223||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0223
74019586|NCT04426695|147591475|SUPERIORITY|||||||0.0072||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0072
74055491|NCT06045026|147662379|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
74055492|NCT06045026|147662379|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
74055493|NCT06045026|147662379|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
74055494|NCT06045026|147662379|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
74055495|NCT06045026|147662379|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
74055496|NCT06045026|147662380|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
74055497|NCT06045026|147662380|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
74055498|NCT06045026|147662380|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
74055499|NCT06045026|147662380|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
74055500|NCT06045026|147662380|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
74055501|NCT06045026|147662380|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
74055502|NCT06045026|147662381|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
74055503|NCT06045026|147662381|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
74055504|NCT06045026|147662381|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
74055505|NCT06045026|147662381|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
74055506|NCT06045026|147662381|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
74055507|NCT06045026|147662381|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
74055508|NCT06045026|147662382|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
74055509|NCT06045026|147662382|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
73881636|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0416|TWO_SIDED|95.0|-0.69|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.01|-0.69|0.0416
74055510|NCT06045026|147662382|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
74055511|NCT06045026|147662382|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
74055512|NCT06045026|147662382|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
74055513|NCT06045026|147662382|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
74055514|NCT06045026|147662383|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
74055515|NCT06045026|147662383|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
74055516|NCT06045026|147662383|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
74055517|NCT06045026|147662383|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
73888175|NCT01746901|147309540|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.1868|TWO_SIDED|95.0|-0.5|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.7|-0.5|0.1868
74019587|NCT04426695|147591476|SUPERIORITY|||||||0.1032||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1032
74019588|NCT04426695|147591476|SUPERIORITY|||||||0.335||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3350
74019589|NCT04426695|147591476|SUPERIORITY|||||||0.1314||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1314
74019590|NCT04426695|147591477|SUPERIORITY|||||||0.00024||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.00024
74019591|NCT04426695|147591477|SUPERIORITY|||||||0.0054||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0054
74019592|NCT04426695|147591477|SUPERIORITY|||||||0.0005||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0005
74019593|NCT04426695|147591484|SUPERIORITY|||||||0.0533||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0533
74019594|NCT04426695|147591484|SUPERIORITY|||||||0.0411||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0411
74019595|NCT04426695|147591484|SUPERIORITY|||||||0.0229||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0229
74019596|NCT04426695|147591485|SUPERIORITY|||||||0.0218|||||||Stratified Log Rank Test|||||||0.0218
74019597|NCT04426695|147591485|SUPERIORITY|||||||0.0156|||||||Stratified Log Rank Test|||||||0.0156
74019598|NCT04426695|147591485|SUPERIORITY|||||||0.0067|||||||Stratified Log Rank Test|||||||0.0067
74019599|NCT04426695|147591489|SUPERIORITY|||||||0.2162||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2162
74019600|NCT04426695|147591489|SUPERIORITY|||||||0.8783||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.8783
74019601|NCT04426695|147591489|SUPERIORITY|||||||0.5583||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5583
74019602|NCT04426695|147591489|SUPERIORITY|||||||0.7189||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.7189
74019603|NCT04426695|147591489|SUPERIORITY|||||||0.0429||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0429
74019604|NCT04426695|147591489|SUPERIORITY|||||||0.2103||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2103
74019605|NCT04426695|147591490|SUPERIORITY|||||||0.0223||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0223
74019606|NCT04426695|147591490|SUPERIORITY|||||||0.1256||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1256
74019607|NCT04426695|147591490|SUPERIORITY|||||||0.023||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0230
74019608|NCT04426695|147591490|SUPERIORITY|||||||0.1298||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1298
74019609|NCT04426695|147591490|SUPERIORITY|||||||0.2642||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2642
74019610|NCT04426695|147591490|SUPERIORITY|||||||0.097||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0970
74055518|NCT06045026|147662383|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
74055519|NCT06045026|147662383|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
74055520|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 4||||<0.0001
74019611|NCT04426695|147591491|SUPERIORITY|||||||0.0147||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0147
74055521|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 8||||<0.0001
74055522|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 12||||<0.0001
74055523|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 16||||<0.0001
74055524|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 20||||<0.0001
74055525|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 24||||<0.0001
74055526|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 4||||<0.0001
74055527|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 8||||<0.0001
74055528|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 12||||<0.0001
74055529|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 16||||<0.0001
74055530|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 20||||<0.0001
74055531|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 24||||<0.0001
74055532|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 4||||<0.0001
74055533|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 8||||<0.0001
74055534|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 12||||<0.0001
74055535|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 16||||<0.0001
74055536|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 20||||<0.0001
74055537|NCT06045026|147662384|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 24||||<0.0001
74055538|NCT06045026|147662385|SUPERIORITY|||||||0.01|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||0.0100
74055539|NCT06045026|147662385|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
74055540|NCT06045026|147662385|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
74055541|NCT06045026|147662385|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
74055542|NCT06045026|147662385|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
74055543|NCT06045026|147662385|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
74055544|NCT06045026|147662386|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
74019612|NCT04426695|147591491|SUPERIORITY|||||||0.0669||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0669
74055545|NCT06045026|147662386|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
74055546|NCT06045026|147662386|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
74055547|NCT06045026|147662386|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
74055548|NCT06045026|147662386|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
74055549|NCT06045026|147662386|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
74055550|NCT06045026|147662388|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 1||||<0.0001
74055551|NCT06045026|147662388|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 2||||<0.0001
74055552|NCT06045026|147662388|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
74055553|NCT06045026|147662388|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
74055554|NCT06045026|147662388|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
74055555|NCT06045026|147662388|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
74055556|NCT06045026|147662388|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
74055557|NCT06045026|147662388|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
74019613|NCT04426695|147591491|SUPERIORITY|||||||0.0094||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0094
74019614|NCT04426695|147591491|SUPERIORITY|||||||0.1306||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1306
74055558|NCT04550234|147662391|OTHER||Geometric mean ratio|57.73|||||TWO_SIDED|90.0|47.07|70.81||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||70.81|47.07|
74055559|NCT04550234|147662391|OTHER||Geometric mean ratio|145.55|||||TWO_SIDED|90.0|118.66|178.52||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||178.52|118.66|
74055560|NCT04550234|147662391|OTHER||Geometric mean ratio|52.07|||||TWO_SIDED|90.0|42.46|63.87||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||63.87|42.46|
74055561|NCT04550234|147662391|OTHER||Geometric mean ratio|101.16|||||TWO_SIDED|90.0|82.48|124.08||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||124.08|82.48|
74055562|NCT04550234|147662391|OTHER||Geometric mean ratio|73.34|||||TWO_SIDED|90.0|61.81|87.03||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||87.03|61.81|
74055563|NCT04550234|147662391|OTHER||Geometric mean ratio|66.33|||||TWO_SIDED|90.0|55.9|78.72||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||78.72|55.90|
74055564|NCT04550234|147662391|OTHER||Geometric mean ratio|106.58|||||TWO_SIDED|90.0|89.81|126.47||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||126.47|89.81|
74055565|NCT04550234|147662391|OTHER||Geometric mean ratio|86.86|||||TWO_SIDED|90.0|83.15|90.74||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||90.74|83.15|
74055566|NCT04550234|147662391|OTHER||Geometric mean ratio|92.3|||||TWO_SIDED|90.0|88.35|96.42||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||96.42|88.35|
74055567|NCT04550234|147662391|OTHER||Geometric mean ratio|89.54|||||TWO_SIDED|90.0|85.71|93.54||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.54|85.71|
74055568|NCT04550234|147662392|OTHER||Geometric mean ratio|102.49|||||TWO_SIDED|90.0|89.12|117.86||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||117.86|89.12|
74055569|NCT04550234|147662392|OTHER||Geometric mean ratio|144.61|||||TWO_SIDED|90.0|125.75|166.31||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||166.31|125.75|
74055570|NCT04550234|147662392|OTHER||Geometric mean ratio|76.72|||||TWO_SIDED|90.0|66.71|88.23||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.23|66.71|
74055571|NCT04550234|147662392|OTHER||Geometric mean ratio|96.19|||||TWO_SIDED|90.0|83.64|110.62||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||110.62|83.64|
73881637|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0353|TWO_SIDED|95.0|-0.71|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.03|-0.71|0.0353
73881638|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.84|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.16|-0.84|0.0040
73881639|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0495|TWO_SIDED|95.0|-0.69|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.00|-0.69|0.0495
74055572|NCT04550234|147662392|OTHER||Geometric mean ratio|89.41|||||TWO_SIDED|90.0|83.86|95.34||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||95.34|83.86|
74055573|NCT04550234|147662392|OTHER||Geometric mean ratio|94.16|||||TWO_SIDED|90.0|88.31|100.4||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||100.40|88.31|
74055574|NCT04550234|147662392|OTHER||Geometric mean ratio|91.7|||||TWO_SIDED|90.0|86.37|97.36||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||97.36|86.37|
74055575|NCT04550234|147662392|OTHER||Geometric mean ratio|91.23|||||TWO_SIDED|90.0|88.01|94.56||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||94.56|88.01|
74055576|NCT04550234|147662392|OTHER||Geometric mean ratio|99.95|||||TWO_SIDED|90.0|96.43|103.61||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||103.61|96.43|
74055577|NCT04550234|147662392|OTHER||Geometric mean ratio|90.13|||||TWO_SIDED|90.0|86.95|93.42||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.42|86.95|
74055578|NCT04550234|147662393|OTHER||Geometric mean ratio|102.91|||||TWO_SIDED|90.0|89.04|118.93||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||118.93|89.04|
74055579|NCT04550234|147662393|OTHER||Geometric mean ratio|146.57|||||TWO_SIDED|90.0|126.82|169.4||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||169.40|126.82|
74055580|NCT04550234|147662393|OTHER||Geometric mean ratio|76.72|||||TWO_SIDED|90.0|66.38|88.67||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.67|66.38|
74055581|NCT04550234|147662393|OTHER||Geometric mean ratio|95.37|||||TWO_SIDED|90.0|82.52|110.23||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||110.23|82.52|
74055582|NCT04550234|147662393|OTHER||Geometric mean ratio|82.6|||||TWO_SIDED|90.0|77.38|88.17||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.17|77.38|
74055583|NCT04550234|147662393|OTHER||Geometric mean ratio|87.14|||||TWO_SIDED|90.0|81.63|93.01||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.01|81.63|
74019615|NCT04426695|147591491|SUPERIORITY|||||||0.3576||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3576
74019616|NCT04426695|147591491|SUPERIORITY|||||||0.1476||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1476
74055584|NCT04550234|147662393|OTHER||Geometric mean ratio|91.45|||||TWO_SIDED|90.0|85.67|97.61||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||97.61|85.67|
74055585|NCT04550234|147662393|OTHER||Geometric mean ratio|90.91|||||TWO_SIDED|90.0|87.98|93.94||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.94|87.98|
74055586|NCT04550234|147662393|OTHER||Geometric mean ratio|99.37|||||TWO_SIDED|90.0|96.17|102.68||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.68|96.17|
74055587|NCT04550234|147662393|OTHER||Geometric mean ratio|89.18|||||TWO_SIDED|90.0|86.3|92.15||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||92.15|86.30|
74055588|NCT04550234|147662405|OTHER||Geometric mean ratio|108.25|||||TWO_SIDED|90.0|94.13|124.49||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||124.49|94.13|
73881640|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.8665|TWO_SIDED|95.0|-0.31|0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.37|-0.31|0.8665
74019617|NCT04426695|147591492|SUPERIORITY|||||||0.0481||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0481
74055589|NCT04550234|147662405|OTHER||Geometric mean ratio|96.57|||||TWO_SIDED|90.0|90.96|102.53||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.53|90.96|
73888176|NCT01746901|147309540|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9944|TWO_SIDED|95.0|-1.6|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-1.6|0.9944
74019618|NCT04426695|147591492|SUPERIORITY|||||||0.0535||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0535
74019619|NCT04426695|147591492|SUPERIORITY|||||||0.0199||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0199
74019620|NCT04426695|147591492|SUPERIORITY|||||||0.2784||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2784
74019621|NCT04426695|147591492|SUPERIORITY|||||||0.251||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2510
74019622|NCT04426695|147591492|SUPERIORITY|||||||0.1702||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1702
74019623|NCT04426695|147591493|SUPERIORITY|||||||0.05||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0500
74019624|NCT04426695|147591493|SUPERIORITY|||||||0.0663||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0663
74019625|NCT04426695|147591493|SUPERIORITY|||||||0.0229||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0229
74019626|NCT04426695|147591493|SUPERIORITY|||||||0.0208||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0208
74019627|NCT04426695|147591493|SUPERIORITY|||||||0.0388||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0388
74019628|NCT04426695|147591493|SUPERIORITY|||||||0.0092||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0092
74019629|NCT04426695|147591497|SUPERIORITY|||||||0.037|||||||stratified log-rank test|||||||0.0370
74019630|NCT04426695|147591497|SUPERIORITY|||||||0.1596|||||||stratified log-rank test|||||||0.1596
74019631|NCT04426695|147591497|SUPERIORITY|||||||0.0444|||||||stratified log-rank test|||||||0.0444
74019632|NCT04426695|147591497|SUPERIORITY|||||||0.1802|||||||stratified log-rank test|||||||0.1802
74019633|NCT04426695|147591497|SUPERIORITY|||||||0.0407|||||||stratified log-rank test|||||||0.0407
74019634|NCT04426695|147591497|SUPERIORITY|||||||0.0523|||||||stratified log-rank test|||||||0.0523
74019635|NCT04426695|147591498|SUPERIORITY|||||||0.0245|||||||ANCOVA|||||||0.0245
74019636|NCT04426695|147591498|SUPERIORITY|||||||0.0554|||||||ANCOVA|||||||0.0554
74019637|NCT04426695|147591498|SUPERIORITY|||||||0.0179|||||||ANCOVA|||||||0.0179
74019638|NCT04426695|147591498|SUPERIORITY|||||||0.0035|||||||ANCOVA|||||||0.0035
74019639|NCT04426695|147591498|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
74019640|NCT04426695|147591498|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
74019641|NCT04426695|147591499|SUPERIORITY|||||||0.0013|||||||ANCOVA|||||||0.0013
74019642|NCT04426695|147591499|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.0010
74019643|NCT04426695|147591499|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
74019644|NCT04426695|147591499|SUPERIORITY|||||||0.025|||||||ANCOVA|||||||0.0250
74019645|NCT04426695|147591499|SUPERIORITY|||||||0.0012|||||||ANCOVA|||||||0.0012
74019646|NCT04426695|147591499|SUPERIORITY|||||||0.0014|||||||ANCOVA|||||||0.0014
74019647|NCT04426695|147591500|SUPERIORITY|||||||0.0623|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0623
74019648|NCT04426695|147591500|SUPERIORITY|||||||0.0203|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0203
74019649|NCT04426695|147591500|SUPERIORITY|||||||0.0193|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0193
73881641|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.9303|TWO_SIDED|95.0|-0.35|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.32|-0.35|0.9303
73881642|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.1039|TWO_SIDED|95.0|-0.62|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.06|-0.62|0.1039
74055590|NCT04550234|147662405|OTHER||Geometric mean ratio|98.75|||||TWO_SIDED|90.0|95.27|102.36||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.36|95.27|
73881643|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.54||0.2547|TWO_SIDED|95.0|-4.78|1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||1.27|-4.78|0.2547
73881644|NCT03192176|147297635|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|1.55||0.0225|TWO_SIDED|95.0|-6.6|-0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-0.50|-6.60|0.0225
74055591|NCT04550234|147662406|OTHER||Geometric mean ratio|109.27|||||TWO_SIDED|90.0|94.55|126.29||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||126.29|94.55|
74055592|NCT04550234|147662406|OTHER||Geometric mean ratio|96.47|||||TWO_SIDED|90.0|90.38|102.97||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.97|90.38|
74055593|NCT04550234|147662406|OTHER||Geometric mean ratio|97.48|||||TWO_SIDED|90.0|94.34|100.73||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||100.73|94.34|
74055594|NCT04550234|147662407|OTHER||Geometric mean ratio|131.28|||||TWO_SIDED|90.0|107.03|161.02||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||161.02|107.03|
74055595|NCT04550234|147662407|OTHER||Geometric mean ratio|96.39|||||TWO_SIDED|90.0|81.23|114.39||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||114.39|81.23|
74055596|NCT04550234|147662407|OTHER||Geometric mean ratio|95.15|||||TWO_SIDED|90.0|91.08|99.4||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||99.40|91.08|
74055597|NCT03026556|147662448|OTHER||Hazard Ratio (HR)|0.766||||0.0844|TWO_SIDED|95.0|0.566|1.037|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.037|0.566|0.0844
74055598|NCT03026556|147662448|OTHER||Hazard Ratio (HR)|1.255||||0.4892|TWO_SIDED|95.0|0.659|2.39|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.390|0.659|0.4892
74055599|NCT03026556|147662449|OTHER||Hazard Ratio (HR)|0.82||||0.0182|TWO_SIDED|95.0|0.696|0.967|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.967|0.696|0.0182
74055600|NCT03026556|147662449|OTHER||Hazard Ratio (HR)|1.374||||0.0702|TWO_SIDED|95.0|0.974|1.939|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.939|0.974|0.0702
74055601|NCT03026556|147662450|OTHER||Hazard Ratio (HR)|0.923||||0.6307|TWO_SIDED|95.0|0.667|1.278|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.278|0.667|0.6307
74055602|NCT03026556|147662450|OTHER||Hazard Ratio (HR)|1.054||||0.8777|TWO_SIDED|95.0|0.54|2.055|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.055|0.540|0.8777
74055603|NCT03026556|147662451|OTHER||Hazard Ratio (HR)|0.223||||0.0023|TWO_SIDED|95.0|0.085|0.585|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.585|0.085|0.0023
74055604|NCT03026556|147662452|OTHER||Hazard Ratio (HR)|0.654||||0.0406|TWO_SIDED|95.0|0.435|0.982|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.982|0.435|0.0406
74055605|NCT03026556|147662452|OTHER||Hazard Ratio (HR)|1.11||||0.8124|TWO_SIDED|95.0|0.469|2.63|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.630|0.469|0.8124
74055606|NCT03026556|147662453|OTHER||Hazard Ratio (HR)|0.856||||0.0901|TWO_SIDED|95.0|0.716|1.025|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.025|0.716|0.0901
74055607|NCT03026556|147662453|OTHER||Hazard Ratio (HR)|1.431||||0.0616|TWO_SIDED|95.0|0.983|2.083|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.083|0.983|0.0616
74055608|NCT03026556|147662454|OTHER||Hazard Ratio (HR)|0.887||||0.2073|TWO_SIDED|95.0|0.736|1.069|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.069|0.736|0.2073
74100337|NCT03743415|147750051|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that reflected average difference between arms over time (weeks 1-13).|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.16||0.81|TWO_SIDED|95.0|-2.5|1.96||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Linear mixed effects models were used for 13 repeated measures of the symptom index, adjusting for baseline value.|Mean of SMSH alone minus mean of SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||1.96|-2.50|.81
74100338|NCT03743415|147750051|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|2.07||0.78|TWO_SIDED|95.0|-4.65|3.49||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|The model included adjustment for baseline value of the symptom index.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||3.49|-4.65|.78
74100339|NCT03743415|147750051|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over time (weeks 1-13).|Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.76||0.27|TWO_SIDED|95.0|-0.66|2.32||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||2.32|-0.66|.27
74019650|NCT04426695|147591500|SUPERIORITY|||||||0.1206|||||||MMRM|||Difference vs. Placebo by Day 29||||0.1206
74019651|NCT04426695|147591500|SUPERIORITY|||||||0.0911|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0911
74019652|NCT04426695|147591500|SUPERIORITY|||||||0.0645|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0645
74019653|NCT04426695|147591501|SUPERIORITY|||||||0.0623|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0623
74019654|NCT04426695|147591501|SUPERIORITY|||||||0.0203|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0203
74019655|NCT04426695|147591501|SUPERIORITY|||||||0.0193|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0193
74019656|NCT04426695|147591501|SUPERIORITY|||||||0.1206|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.1206
74019657|NCT04426695|147591501|SUPERIORITY|||||||0.0911|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0911
74019658|NCT04426695|147591501|SUPERIORITY|||||||0.0645|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0645
74019659|NCT04426695|147591502|SUPERIORITY|||||||0.0481||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0481
74019660|NCT04426695|147591502|SUPERIORITY|||||||0.988||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.9880
74019661|NCT04426695|147591502|SUPERIORITY|||||||0.2498||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2498
74019662|NCT04426695|147591502|SUPERIORITY|||||||1||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||1.0000
74019663|NCT04426695|147591502|SUPERIORITY|||||||0.0457||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0457
74019664|NCT04426695|147591502|SUPERIORITY|||||||0.2153||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2153
74019665|NCT04426695|147591503|SUPERIORITY|||||||0.0811||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0811
74019666|NCT04426695|147591503|SUPERIORITY|||||||0.6701||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.6701
74019667|NCT04426695|147591503|SUPERIORITY|||||||0.2006||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2006
74055609|NCT03026556|147662454|OTHER||Hazard Ratio (HR)|1.504||||0.0417|TWO_SIDED|95.0|1.015|2.228|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.228|1.015|0.0417
74055610|NCT03026556|147662456|OTHER||Hazard Ratio (HR)|0.709||||0.2663|TWO_SIDED|95.0|0.387|1.299|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.299|0.387|0.2663
74055611|NCT03026556|147662456|OTHER||Hazard Ratio (HR)|0.864||||0.8112|TWO_SIDED|95.0|0.261|2.863|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.863|0.261|0.8112
74055612|NCT03026556|147662457|OTHER||Hazard Ratio (HR)|0.766||||0.1227|TWO_SIDED|95.0|0.546|1.075|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.075|0.546|0.1227
74055613|NCT03026556|147662457|OTHER||Hazard Ratio (HR)|1.138||||0.7115|TWO_SIDED|95.0|0.573|2.26|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.260|0.573|0.7115
74019668|NCT04426695|147591503|SUPERIORITY|||||||0.3313||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3313
74019669|NCT04426695|147591503|SUPERIORITY|||||||0.5542||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5542
74055614|NCT03026556|147662458|OTHER||Hazard Ratio (HR)|0.923||||0.4727|TWO_SIDED|95.0|0.741|1.149|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.149|0.741|0.4727
74055615|NCT03026556|147662458|OTHER||Hazard Ratio (HR)|1.721||||0.0275|TWO_SIDED|95.0|1.062|2.79|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.790|1.062|0.0275
74055616|NCT03026556|147662459|OTHER||Hazard Ratio (HR)|1.346||||0.2309|TWO_SIDED|95.0|0.828|2.189|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.189|0.828|0.2309
74055617|NCT03026556|147662459|OTHER||Hazard Ratio (HR)|1.557||||0.3333|TWO_SIDED|95.0|0.635|3.821|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||3.821|0.635|0.3333
74055618|NCT03026556|147662460|OTHER||Hazard Ratio (HR)|1.008||||0.9359|TWO_SIDED|95.0|0.829|1.226|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.226|0.829|0.9359
74055619|NCT03026556|147662460|OTHER||Hazard Ratio (HR)|1.024||||0.8947|TWO_SIDED|95.0|0.716|1.465|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.465|0.716|0.8947
74055620|NCT01294319|147662461|SUPERIORITY|||||||0.4872|||||||Fisher Exact|||||||0.4872
74100340|NCT03743415|147750051|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|1.35||0.19|TWO_SIDED|95.0|-0.88|4.39||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||4.39|-0.88|.19
74100341|NCT03743415|147750052|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over weeks 5-13.|Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|2.46||0.53|TWO_SIDED|95.0|-3.3|6.36||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||6.36|-3.30|.53
74100342|NCT03743415|147750052|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|3.92||0.97|TWO_SIDED|95.0|-5.7|9.68||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||9.68|-5.70|.97
74100343|NCT03743415|147750052|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over weeks 5-13.|Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|1.94||0.31|TWO_SIDED|95.0|-1.83|5.75||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||5.75|-1.83|.31
74055621|NCT01294319|147662462|SUPERIORITY|||||||0.2786|||||||t-test, 2 sided|||||||0.2786
74055622|NCT02924129|147662463|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||Significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
74055623|NCT02924129|147662464|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|9.0|||<|0.001|TWO_SIDED|95.0|-2.4|20.4||significance threshold (α) of 0.05|t-test, 2 sided|||||20.4|-2.4|<0.001
74055624|NCT02924129|147662465|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|14.6|||<|0.001|TWO_SIDED|95.0|2.9|26.3||significance threshold (α) of 0.05|t-test, 2 sided|||||26.3|2.9|<0.001
74100344|NCT03743415|147750052|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|2.77||0.61|TWO_SIDED|95.0|-2.13|8.74||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||8.74|-2.13|.61
74100345|NCT03743415|147750053|SUPERIORITY|Key parameter was the difference between arms at week 13.|Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|1.14||0.44|TWO_SIDED|95.0|-3.12|1.35||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.35|-3.12|.44
74100346|NCT03743415|147750053|SUPERIORITY|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|1.15||0.95|TWO_SIDED|95.0|-2.32|2.18||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.||2.18|-2.32|.95
74055625|NCT02924129|147662466|NON_INFERIORITY|non-inferiority margin (δ) of 10%||||||0.002||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||0.002
74055626|NCT02924129|147662467|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
74055627|NCT02924129|147662468|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
74055628|NCT02924129|147662469|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|10.7|||<|0.001|TWO_SIDED|95.0|-1.8|23.3||significance threshold (α) of 0.05|t-test, 2 sided|||||23.3|-1.8|<0.001
74055629|NCT02924129|147662470|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|15.4|||<|0.001|TWO_SIDED|95.0|2.5|28.3||significance threshold (α) of 0.05|t-test, 2 sided|||||28.3|2.5|<0.001
74055630|NCT02924129|147662471|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001|||||||normal approximation to the binomial|||||||<0.001
74055631|NCT02924129|147662472|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
74100347|NCT03743415|147750053|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.96||0.97|TWO_SIDED|95.0|-1.85|1.93||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.93|-1.85|.97
74100348|NCT03743415|147750053|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.96||0.74|TWO_SIDED|95.0|-1.56|2.2||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.20|-1.56|.74
74100349|NCT03743415|147750054|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|2.31||0.98|TWO_SIDED|95.0|-4.49|4.58||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus mean of SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.58|-4.49|.98
74100350|NCT03743415|147750054|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.34||0.7|TWO_SIDED|95.0|-5.48|3.68||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.68|-5.48|.70
74100351|NCT03743415|147750054|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|1.85||0.27|TWO_SIDED|95.0|-5.62|1.62||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.62|-5.62|.27
74100352|NCT03743415|147750054|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|1.84||0.91|TWO_SIDED|95.0|-3.4|3.81||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.81|-3.40|.91
74100353|NCT03743415|147750055|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|1.06||0.06|TWO_SIDED|95.0|-3.98|0.19||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||0.19|-3.98|.06
74055632|NCT01000311|147662520|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|83.0|||||TWO_SIDED|95.0|83.0|93.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 80% for the serogroup A.||93|83|
74100354|NCT03743415|147750055|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|1.0||0.09|TWO_SIDED|95.0|-3.81|0.11||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||0.11|-3.81|.09
74100355|NCT03743415|147750055|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.97||0.89|TWO_SIDED|95.0|-1.77|2.04||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.04|-1.77|.89
74100356|NCT03743415|147750055|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.96||0.47|TWO_SIDED|95.0|-1.2|2.58||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.58|-1.20|.47
74100357|NCT03743415|147750056|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-1.41|STANDARD_ERROR_OF_MEAN|1.94||0.45|TWO_SIDED|95.0|-5.22|2.39||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.39|-5.22|.45
74100358|NCT03743415|147750056|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.97||0.82|TWO_SIDED|95.0|-3.59|4.12||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.12|-3.59|.82
74055633|NCT01000311|147662520|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|90.0|||||TWO_SIDED|95.0|90.0|98.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup C.||98|90|
74100359|NCT03743415|147750056|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|1.88||0.77|TWO_SIDED|95.0|-3.13|4.23||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.23|-3.13|.77
74055634|NCT01000311|147662520|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|93.0|||||TWO_SIDED|95.0|93.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup W.||99|93|
74055635|NCT01000311|147662520|SUPERIORITY_OR_OTHER||Lowe limit of 95% confidence interval|92.0|||||TWO_SIDED|95.0|92.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup Y.||99|92|
74100360|NCT03743415|147750056|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|1.87||0.86|TWO_SIDED|95.0|-3.98|3.34||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.34|-3.98|.86
74100361|NCT00976911|147750098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|15.7|||||TWO_SIDED|95.0|6.5|24.8||||||||24.8|6.5|
74055636|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to diphtheria toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-2.9|2.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to diphtheria toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||2.6|-2.9|
74055637|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to tetanus toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-3.3|3.9|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to tetanus toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||3.9|-3.3|
73881645|NCT03192176|147297635|SUPERIORITY||LSMean differencce|-4.3|STANDARD_ERROR_OF_MEAN|1.55||0.0058|TWO_SIDED|95.0|-7.38|-1.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-1.26|-7.38|0.0058
74100362|NCT00976911|147750098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Pearson's chi-square|unstratified analysis||||||0.0010
74100363|NCT00976911|147750098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Cochran-Mantel-Haenszel|||||||0.0007
74100364|NCT00976911|147750099|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45||||0.0202|TWO_SIDED|95.0|0.225|0.9||Unstratified analysis|Log Rank||Hazard ratio was estimated by unstratified Cox regression model.|||0.900|0.225|0.0202
74100365|NCT00976911|147750099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0081|TWO_SIDED||||||Peto-Peto-Prentice|||||||0.0081
74019670|NCT04426695|147591503|SUPERIORITY|||||||0.2214||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2214
74019671|NCT04426695|147591504|SUPERIORITY|||||||0.0389||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0389
74019672|NCT04426695|147591504|SUPERIORITY|||||||0.5208||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5208
74019673|NCT04426695|147591504|SUPERIORITY|||||||0.1079||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1079
74019674|NCT04426695|147591504|SUPERIORITY|||||||0.3315||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3315
74019675|NCT04426695|147591504|SUPERIORITY|||||||0.5797||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5797
74019676|NCT04426695|147591504|SUPERIORITY|||||||0.3036||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3036
74019677|NCT04426695|147591505|SUPERIORITY|||||||0.0364||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0364
74019678|NCT04426695|147591505|SUPERIORITY|||||||0.2795||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2795
74019679|NCT04426695|147591505|SUPERIORITY|||||||0.0588||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0588
74019680|NCT04426695|147591505|SUPERIORITY|||||||0.0364||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0364
74019681|NCT04426695|147591505|SUPERIORITY|||||||0.2795||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2795
74019682|NCT04426695|147591505|SUPERIORITY|||||||0.0588||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0588
74019683|NCT04426695|147591506|SUPERIORITY|||||||0.2635||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2635
74019684|NCT04426695|147591506|SUPERIORITY|||||||0.8013||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.8013
74019685|NCT04426695|147591506|SUPERIORITY|||||||0.416||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.4160
74019686|NCT04426695|147591506|SUPERIORITY|||||||0.2194||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2194
74019687|NCT04426695|147591506|SUPERIORITY|||||||0.324||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3240
74055638|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||TWO_SIDED|95.0|-12.1|4.3|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis toxin (PT), when DTaP vaccine is given, compared with MenACWY-CRM compared with when DTaP vaccine is given alone||4.3|-12.1|
74055639|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis (FHA antigen), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|4.0|||||TWO_SIDED|95.0|-5.1|13.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis FHA antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||13.6|-5.1|
74055640|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis pertactin antigen, when DTaP vaccine is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-8.8|9.1|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis pertactin antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP is given alone.||9.1|-8.8|
74055641|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-2.0|||||TWO_SIDED|95.0|-10.6|6.8|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis FIM antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||6.8|-10.6|
74055642|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to hepatitis B, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of hepatitis B vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-5.2|4.5|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to hepatitis B antigen, when hepatitis B vaccine is given with MenACWY-CRM compared with when hepatitis B vaccine is given alone.||4.5|-5.2|
74055643|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to Hib vaccine, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of Hib vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|5.0|||||TWO_SIDED|95.0|0.0|11.2|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to Hib antigen, when Hib vaccine is given with MenACWY-CRM compared with when Hib vaccine is given alone.||11.2|0|
74055644|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 1), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||TWO_SIDED|95.0|-3.1|5.4|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 1), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||5.4|-3.1|
74055645|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 2), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||TWO_SIDED|95.0|-1.4|3.0|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 2), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||3|-1.4|
74055646|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 3), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|-1.0|||||TWO_SIDED|95.0|-3.3|1.7|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 3), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||1.7|-3.3|
74055647|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|1.0|||||TWO_SIDED|95.0|-1.9|4.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 4 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||4.6|-1.9|
74055648|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||TWO_SIDED|95.0|-10.3|3.2|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 6B antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||3.2|-10.3|
74100366|NCT00976911|147750101|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.379|||<|0.0001|TWO_SIDED|95.0|0.296|0.485|||Log Rank||Stratified analysis:Strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (less than \[\<\] 3 or 3-6 months). Cox regression model was used to determine the hazard ratio.|||0.485|0.296|<0.0001
74100367|NCT00976911|147750101|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.366|0.577|||Log Rank|Unstratified analysis||||0.577|0.366|<0.0001
74100368|NCT00976911|147750101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Peto-Peto-Prentice|Unstratified analysis||||||<0.0001
74055649|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||TWO_SIDED|95.0|-8.7|2.3|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 9V antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||2.3|-8.7|
74055650|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-2.8|3.0|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 14 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||3.0|-2.8|
74055651|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||TWO_SIDED|95.0|-7.3|1.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 18C antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||1.6|-7.3|
74055652|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|3.0|||||TWO_SIDED|95.0|1.3|7.1|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 19F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||7.1|1.3|
74055653|NCT01000311|147662524|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-5.0|||||TWO_SIDED|95.0|-11.4|0.5|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 23F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||0.5|-11.4|
74055654|NCT01000311|147662525|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.02|||||TWO_SIDED|95.0|0.81|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis toxin (PT), when DTaP is given with MenACWY-CRM compared with when DTap is given alone||1.28|0.81|
74055655|NCT01000311|147662525|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis FHA antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.9|1.19|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis FHA antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.19|0.9|
74055656|NCT01000311|147662525|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis pertactin antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.84|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis pertactin antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.28|0.84|
74055657|NCT01000311|147662525|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.09|||||TWO_SIDED|95.0|0.88|1.35|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis FIM antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.35|0.88|
74055658|NCT01000311|147662526|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.98|||||TWO_SIDED|95.0|0.8|1.19|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 4 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.19|0.8|
74055659|NCT01000311|147662526|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.76|||||TWO_SIDED|95.0|0.62|0.93|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 6B antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||0.93|0.62|
74100369|NCT00976911|147750101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Peto-Peto-Prentice|Stratified analysis:Strata were chemotherapy selected, prior anti-angiogenic therapy, and platinum-free interval.||||||<0.0001
74100370|NCT00976911|147750102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.833||||0.136|TWO_SIDED|95.0|0.655|1.059||Unstratified analysis|Log Rank|||||1.059|0.655|0.1360
74100371|NCT00976911|147750102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0715|TWO_SIDED|||||Unstratified analysis|Peto-Peto-Prentice|||||||0.0715
74055660|NCT01000311|147662526|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.87|||||TWO_SIDED|95.0|0.72|1.06|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 9V antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.06|0.72|
74055661|NCT01000311|147662526|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.84|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 14 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.28|0.84|
74055662|NCT01000311|147662526|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.99|||||TWO_SIDED|95.0|0.82|1.2|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 18C antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.2|0.82|
74055663|NCT01000311|147662526|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.89|||||TWO_SIDED|95.0|0.73|1.07|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 19F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.07|0.73|
74055664|NCT01000311|147662526|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.84|||||TWO_SIDED|95.0|0.68|1.04|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 23F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.04|0.68|
74055665|NCT02780869|147662532|NON_INFERIORITY|The primary endpoint was designed to establish comparable efficacy based upon a non-inferiority margin of 10% for the difference in the probability of TTH within 6 minutes comparing HEMOBLAST™ to G+T (HEMOBLAST™- G+T). Letting θ denote the true difference in the probability of hemostasis at 6 minutes between HEMOBLAST™ to G+T, the trial will test the null hypothesis H0: θ ≤ -0.10 vs. the alternative hypothesis HA : θ \> -0.10 using a one-sided level 0.025 test.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified adjustments for surgery type were made using the Cochran-Mantel-Haenszel weighting.||||||<0.0001
74055666|NCT02780869|147662532|SUPERIORITY|||||||0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Cochran-Mantel-Haenszel|||A secondary endpoint of superiority of HEMOBLAST relative to G+T for success at achieving hemostasis within 6 minutes was evaluated.||||0.0001
74055667|NCT02780869|147662533|SUPERIORITY||||||<|0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Regression, Linear|||The difference in mean preparation time was tested using a linear regression model with stratified adjustment for surgery type.||||<0.0001
74055668|NCT02780869|147662534|NON_INFERIORITY|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.|||||<|0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic|||||||<0.0001
74055669|NCT02780869|147662534|SUPERIORITY|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.||||||0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic|||||||0.0001
74055670|NCT01377194|147662632|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.303||||0.0027|TWO_SIDED|95.0|-5.457|-1.148|||mixed-model for repeated measures|||||-1.148|-5.457|0.0027
74055671|NCT01377194|147662632|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.141||||0.0043|TWO_SIDED|95.0|-5.293|-0.988|||mixed-model for repeated measures|||||-0.988|-5.293|0.0043
74055672|NCT01377194|147662633|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.827||||0.0459|TWO_SIDED|95.0|-3.62|-0.033|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.033|-3.620|0.0459
73881646|NCT03192176|147297635|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.56||0.0301|TWO_SIDED|95.0|-6.48|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-0.33|-6.48|0.0301
74055673|NCT01377194|147662633|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.72||||0.0028|TWO_SIDED|95.0|-4.494|-0.946|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.946|-4.494|0.0028
74055674|NCT00387621|147662634|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|With Bonferroni correction for multiple comparisons||||||<0.05
74055675|NCT00387621|147662635|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||rank-sum test|Rank-sum test was used due to non-normality of data with Bonferroni correction for multiple comparisons||||||<0.05
74055676|NCT02451137|147662644|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0308|TWO_SIDED|95.4|1.01|1.39||Threshold for significance at 0.046 level.|Regression, Logistic|||A logistic regression model was used with treatment arm as a fixed effect and adjusted for: randomization strata of HbA1c target (\<8%,\<7%), sulfonylurea (SU) use (yes/no), glucagon like peptide1-receptor agonists (GLP-1 RA) use (yes/no) and baseline HbA1c (as continuous).||1.39|1.01|0.0308
73881647|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.55||0.322|TWO_SIDED|95.0|-4.59|1.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||1.51|-4.59|0.3220
74055677|NCT03747497|147662657|OTHER||Median Difference (Net)|-0.6|||||TWO_SIDED|95.0|-14.0|2.8||||||||2.8|-14.0|
74055678|NCT02687815|147662975|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.63|TWO_SIDED|95.0|0.69|1.85|||Regression, Cox|||||1.85|0.69|0.63
74055679|NCT02687815|147662976|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.46|TWO_SIDED|95.0|0.63|2.75|||Regression, Cox|||||2.75|0.63|0.46
74055680|NCT02687815|147662977|SUPERIORITY||Odds Ratio (OR)|0.99||||0.99|TWO_SIDED|95.0|0.66|1.52|||Regression, Logistic|||||1.52|0.66|0.99
74100372|NCT00976911|147750102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.2711|TWO_SIDED|95.0|0.678|1.116||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Log Rank|||||1.116|0.678|0.2711
74100373|NCT00976911|147750102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089|TWO_SIDED|||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Peto-Peto-Prentice|||||||0.0890
74100374|NCT00976911|147750103|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|8.8||||0.1859|TWO_SIDED|95.0|-3.8|21.4|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus Week 8/9||21.4|-3.8|0.1859
74055681|NCT02687815|147662978|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.049|TWO_SIDED|95.0|0.001|8.8|||Regression, Linear|||||8.80|0.001|0.049
74055682|NCT01399619|147662987|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-value corresponds to a two sided test against the historical rate of 40%.|normal approximation|||the SVR12 rate in total Faldaprevir group compared with the historical rate of 40%.||||<0.0001
74055683|NCT00399542|147663026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||70.6% improvement in response with lubiprostone at 90% statistical power||||0.023
74055684|NCT00399542|147663027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.391|||||||van Elteren nonparametric test|Adjusted for center||||||0.391
74055685|NCT00399542|147663028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.151|||||||van Elteren nonparametric test|Adjusted for center||||||0.151
74055686|NCT00399542|147663029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.163|||||||van Elteren nonparametric test|Adjusted for center||||||0.163
74100375|NCT00976911|147750103|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|3.5||||0.8309|TWO_SIDED|95.0|-14.0|20.9|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 16/18||20.9|-14|0.8309
74100376|NCT00976911|147750103|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|9.3||||0.579|TWO_SIDED|95.0|-15.0|34.1|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 24||34.1|-15|0.5790
74100377|NCT00976911|147750103|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|-4.8||||0.7339|TWO_SIDED|95.0|-40.0|30.6|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 30||30.6|-40|0.7339
73881648|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|1.54||0.8782|TWO_SIDED|95.0|-2.8|3.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||3.27|-2.80|0.8782
74055687|NCT00399542|147663030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.185|||||||van Elteren nonparametric test|Adjusted for center||||||0.185
74055688|NCT00399542|147663031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Cochran-Mantel-Haenszel|||||||0.300
74055689|NCT00399542|147663032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.303||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.303
74055690|NCT00399542|147663033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.047
74055691|NCT00399542|147663034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.008
74055692|NCT00399542|147663035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.663|||||||van Elteren nonparametric test|Adjusted for center||||||0.663
74055693|NCT00399542|147663036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.224|||||||van Elteren nonparametric test|Adjusted for center||||||0.224
74055694|NCT00399542|147663037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.271|||||||van Elteren nonparametric test|Adjusted for center||||||0.271
74055695|NCT00399542|147663038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.945|||||||van Elteren nonparametric test|Adjusted for center||||||0.945
74055696|NCT00399542|147663039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352|||||||van Elteren nonparametric test|||||||0.352
74055697|NCT00399542|147663040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||van Elteren nonparametric test|Adjusted for center||||||0.180
74055698|NCT00399542|147663041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275|||||||van Elteren nonparametric test|Adjusted for center||||||0.275
73881649|NCT03192176|147297635|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.55||0.0069|TWO_SIDED|95.0|-7.27|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-1.17|-7.27|0.0069
74055699|NCT00399542|147663042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.722|||||||van Elteren nonparametric test|Adjusted for center||||||0.722
74055700|NCT00399542|147663043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177|||||||van Elteren nonparametric test|Adjusted for center||||||0.177
74055701|NCT00399542|147663044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.082|||||||van Elteren nonparametric test|Adjusted for center||||||0.082
74055702|NCT00399542|147663045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||van Elteren nonparametric test|Adjusted for center||||||0.110
74055703|NCT00399542|147663046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146|||||||van Elteren nonparametric test|Adjusted for center||||||0.146
74055704|NCT00399542|147663047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||van Elteren nonparametric test|Adjusted for center||||||0.373
74055705|NCT00399542|147663048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|||||||van Elteren nonparametric test|Adjusted for center||||||0.339
74055706|NCT00399542|147663049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||Cochran-Mantel-Haenszel|||||||0.023
74055707|NCT00399542|147663050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||Cochran-Mantel-Haenszel|||||||0.073
74055708|NCT00399542|147663051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||ANCOVA|Adjusted for center||||||0.062
74055709|NCT00399542|147663052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||van Elteren nonparametric test|||||||0.060
74055710|NCT00399542|147663053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||van Elteren nonparametric test|||||||0.290
74055711|NCT00399542|147663054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.495|||||||van Elteren nonparametric test|||||||0.495
74055712|NCT00612456|147663066|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|5.83|STANDARD_ERROR_OF_MEAN|18.332||0.6241|TWO_SIDED|95.0|-31.05|42.71||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||42.71|-31.05|0.6241
74055713|NCT00612456|147663066|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|11.87|STANDARD_ERROR_OF_MEAN|19.081||0.7315|TWO_SIDED|95.0|-26.52|50.26||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||50.26|-26.52|0.7315
74055714|NCT00612456|147663066|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.76|STANDARD_ERROR_OF_MEAN|18.566||0.6212|TWO_SIDED|95.0|-31.65|43.18||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||43.18|-31.65|0.6212
74055715|NCT00612456|147663066|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|20.662||0.5987|TWO_SIDED|95.0|-36.44|46.84||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||46.84|-36.44|0.5987
74055716|NCT00612456|147663066|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Median Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|18.114||0.482|TWO_SIDED|95.0|-37.28|35.64||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||35.64|-37.28|0.4820
74055717|NCT00612456|147663066|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|19.9|STANDARD_ERROR_OF_MEAN|18.496||0.8562|TWO_SIDED|95.0|-17.33|57.13||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||57.13|-17.33|0.8562
74055718|NCT00612456|147663066|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|18.3||0.488|TWO_SIDED|95.0|-37.46|36.35||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||36.35|-37.46|0.4880
73888177|NCT01746901|147309540|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.2322|TWO_SIDED|95.0|-0.6|2.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.6|-0.6|0.2322
74055719|NCT00612456|147663066|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|13.97|STANDARD_ERROR_OF_MEAN|20.008||0.7556|TWO_SIDED|95.0|-26.38|54.32||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||54.32|-26.38|0.7556
74055720|NCT00612456|147663073|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|1.29||0.0015|TWO_SIDED|95.0|1.74|6.91|||ANCOVA|||Comparison between Baseline value and Day 29 value.||6.91|1.74|0.0015
74055721|NCT00612456|147663073|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|1.403||0.5921|TWO_SIDED|95.0|-2.05|3.57|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.57|-2.05|0.5921
74055722|NCT00612456|147663073|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|1.988||0.9646|TWO_SIDED|95.0|-3.89|4.07|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.07|-3.89|0.9646
74055723|NCT00612456|147663073|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|4.75||||0.0003|TWO_SIDED|95.0|2.32|7.19|||ANCOVA|||Comparison between Baseline value and Day 29 value.||7.19|2.32|0.0003
74055724|NCT00612456|147663073|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.326||0.2208|TWO_SIDED|95.0|-1.02|4.3|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.30|-1.02|0.2208
74055725|NCT00612456|147663073|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|1.927||0.9847|TWO_SIDED|95.0|-3.9|3.83|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.83|-3.90|0.9847
74055726|NCT00612456|147663073|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|1.376||0.0142|TWO_SIDED|95.0|0.75|6.31|||ANCOVA|||Comparison between Baseline value and Day 29 value.||6.31|0.75|0.0142
74055727|NCT00612456|147663073|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|1.419||0.5547|TWO_SIDED|95.0|-2.02|3.71|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.71|-2.02|0.5547
74055728|NCT00612456|147663073|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|2.287||0.9114|TWO_SIDED|95.0|-4.37|4.88|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.88|-4.37|0.9114
74055729|NCT00612456|147663076|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.383||0.0534|TWO_SIDED|95.0|-0.01|1.53|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.53|-0.01|0.0534
74055730|NCT00612456|147663076|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|0.409||0.0508|TWO_SIDED|95.0|0.0|1.64|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.64|-0.00|0.0508
74055731|NCT00612456|147663076|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.61||||0.3141|TWO_SIDED|95.0|-0.6|1.83|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.83|-0.60|0.3141
74055732|NCT00612456|147663076|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.395||0.6018|TWO_SIDED|95.0|-1.04|0.62|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||0.62|-1.04|0.6018
74055733|NCT00612456|147663076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.476||0.0509|TWO_SIDED|95.0|0.0|2.0||Statistics has been presented for least square means.|ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||2.00|-0.00|0.0509
74055734|NCT00612456|147663076|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.566||0.3976|TWO_SIDED|95.0|-0.7|1.68|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||1.68|-0.70|0.3976
74055735|NCT00612456|147663076|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.385||0.241|TWO_SIDED|95.0|-0.32|1.23|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||1.23|-0.32|0.2410
74055736|NCT00612456|147663076|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|0.412||0.0032|TWO_SIDED|95.0|0.44|2.09|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||2.09|0.44|0.0032
74055737|NCT00612456|147663076|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.581||0.3185|TWO_SIDED|95.0|-0.58|1.75|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||1.75|-0.58|0.3185
74055738|NCT00612456|147663076|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.377||0.1074|TWO_SIDED|95.0|-0.14|1.37|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.37|-0.14|0.1074
74055739|NCT00612456|147663076|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|0.402||0.0403|TWO_SIDED|95.0|0.04|1.65|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.65|0.04|0.0403
74055740|NCT00612456|147663076|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.594||0.249|TWO_SIDED|95.0|-0.5|1.88|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.88|-0.50|0.2490
74055741|NCT00920582|147663097|SUPERIORITY||Odds Ratio (OR)|1.348||||0.609|TWO_SIDED|95.0|0.431|4.219|||Mantel Haenszel|||||4.219|0.431|0.609
74055742|NCT00920582|147663097|SUPERIORITY||Odds Ratio (OR)|1.356||||0.601|TWO_SIDED|95.0|0.453|4.23|||Mantel Haenszel|||||4.230|0.453|0.601
74055743|NCT00920582|147663097|SUPERIORITY||Odds Ratio (OR)|1.624||||0.4|TWO_SIDED|95.0|0.521|5.066|||Mantel Haenszel|||||5.066|0.521|0.400
74055744|NCT00920582|147663099|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.365|TWO_SIDED|95.0|-0.086|0.031|||ANCOVA|||||0.031|-0.086|0.365
74055745|NCT00920582|147663099|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.842|TWO_SIDED|95.0|-0.078|0.064|||ANCOVA|||||0.064|-0.078|0.842
74055746|NCT00920582|147663099|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.565|TWO_SIDED|95.0|-0.089|0.171|||ANCOVA|||||0.171|-0.089|0.565
74055747|NCT00920582|147663104|SUPERIORITY||Odds Ratio (OR)|2.197||||0.142|TWO_SIDED|95.0|0.764|6.312|||Mantel Haenszel|||||6.312|0.764|0.142
74055748|NCT00920582|147663104|SUPERIORITY||Odds Ratio (OR)|1.487||||0.46|TWO_SIDED|95.0|0.517|4.278|||Mantel Haenszel|||||4.278|0.517|0.460
74055749|NCT00920582|147663104|SUPERIORITY||Odds Ratio (OR)|1.954||||0.199|TWO_SIDED|95.0|0.69|5.532|||Mantel Haenszel|||||5.532|0.690|0.199
74055750|NCT03301272|147663139|OTHER||Difference in differences|0.0||||0.5|TWO_SIDED|||||The threshold for statistical significance is 0.05|Regression, Linear|||||||0.5
74055751|NCT03457701|147663144|SUPERIORITY||Adjusted mean difference.|0.02||||0.9971|TWO_SIDED|95.0|-10.13|10.16|||Mixed Models Analysis||Analysis was based on a mixed effects model fitted with fixed effect terms for treatment, period, and iron isotope type and a random participant effect.|The null hypotheses is defined as the difference in fractional iron absorption between treatment arms (Daprodustat - rhEPO \[i.e., epoetin alfa or darbepoetin alfa\]) is equal to zero.||10.16|-10.13|0.9971
74055752|NCT02260791|147663238|EQUIVALENCE|-12% to +15% equivalence margin using 90% CI around the difference in ACR20 response rate|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|90.0|-7.3|3.6||||||The difference and its 90% Confidence Interval (CI) for primary endpoint between FKB327 and Humira were estimated. If the 90% CI fell entirely between pre-specified equivalence margin (-12% to +15%), then FKB327 was considered equivalent to Humira.||3.6|-7.3|
74055753|NCT02260791|147663239|EQUIVALENCE|If the 2-sided 95% CI for the difference in DAS28-CRP at Week 24 between FKB327 and Humira fell entirely between -0.6 and +0.6 then FKB327 was considered equivalent to Humira.|Difference in least square mean|0.01|||||TWO_SIDED|95.0|-0.16|0.18||||||The secondary hypothesis involved equivalence of the difference between FKB327 and Humira in DAS28-CRP at Week 24. Based on the repeated measures analysis model, the difference and its 95% CI in the least-squares means (LSMs) for DAS28-CRP at Week 24 between FKB327 and Humira were estimated. If the 95% CI fell entirely between the pre-specified margin (+/- 0.6), then FKB327 was considered equivalent to Humira.||0.18|-0.16|
74100378|NCT04414345|147750112|SUPERIORITY||Disease Rate Ratio|0.98|STANDARD_DEVIATION|0.1|||TWO_SIDED|95.0|0.797|1.188||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. CNM-Au8 slowed progression) was 0.59059. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by CNM-Au8 relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||"The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality.~The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes."|1.188|0.797|
74055754|NCT02748096|147663263|OTHER||||||<|0.05||||||A p value of less than 0.05 was considered statistically significant for all the radiographic parameters .|t-test, 2 sided|This test applies to comparison between the two treatment arms and assesses all the radiographic parameters||The sample size was calculated from a previous study that used similar radiological assessments to compare OUKAs performed using conventional instrumentation and computer navigation. In this study, the standard deviation of the tibia varus/valgus angle for the control group was 3.6°. Assuming a minimum clinically important difference of 3°, the SMD would be 0.8. Hence with a power of 0.8 and significance level of 0.05, a total sample size of 44 patients (22 in each group) was required.||||<0.05
74055755|NCT02748096|147663264|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74055756|NCT02748096|147663265|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74055757|NCT01153971|147663280|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74055758|NCT03410693|147663298|SUPERIORITY||ORR difference (R-C)|-2.1|||=|0.6991|TWO_SIDED|95.0|-14.0|9.9|||Fisher Exact|||||9.9|-14.0|=0.6991
74055759|NCT03410693|147663298|SUPERIORITY||ORR difference (R - C)|-4.5|||=|0.7944|TWO_SIDED|95.0|-18.9|9.9|||Fisher Exact|||||9.9|-18.9|=0.7944
74055760|NCT03410693|147663299|SUPERIORITY||DCR difference (R-C)|-5.1|||=|0.7962|TWO_SIDED|95.0|-19.9|9.7|||Fisher Exact|||||9.7|-19.9|=0.7962
74055761|NCT03410693|147663299|SUPERIORITY||DCR difference (R-C)|-10.3|||=|0.9109|TWO_SIDED|95.0|-27.5|6.9|||Fisher Exact|||||6.9|-27.5|=0.9109
74055762|NCT03410693|147663300|SUPERIORITY||Hazard Ratio (HR)|1.226|||=|0.8672|TWO_SIDED|95.0|0.853|1.762|||Log Rank|||||1.762|0.853|= 0.8672
74055763|NCT03410693|147663300|SUPERIORITY||Hazard Ratio (HR)|1.341||||0.9171|TWO_SIDED|95.0|0.88|2.043|||Log Rank|||||2.043|0.880|0.9171
74055764|NCT03628781|147663310|SUPERIORITY||Odds Ratio (OR)|0.384||||0.535|TWO_SIDED||||||Chi-squared|||||||.535
74055765|NCT03628781|147663311|SUPERIORITY||Slope|0.018|STANDARD_ERROR_OF_MEAN|0.081||0.829|TWO_SIDED||||||ANOVA|||||||.829
74055766|NCT03628781|147663312|SUPERIORITY||Slope|-0.105|STANDARD_ERROR_OF_MEAN|0.093||0.357|TWO_SIDED||||||ANOVA|||||||.357
74055767|NCT03628781|147663313|SUPERIORITY||Slope|-0.035|STANDARD_ERROR_OF_MEAN|0.126||0.782|TWO_SIDED||||||ANOVA|||||||.782
74055768|NCT00656669|147663314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of sunitinib monotherapy||From Taghian et al., we used a mean IFP of 6.5 at baseline and a standard deviation of 6.1. We would like to detect a 50% reduction of IFP (to 3.25 mmHg) with sunitinib monotherapy, so the effect size would be 3.25/6.1=0.53. A two-sided paired t-test has 80% power to detect an effect size of .53 and level of significance .05 when the sample size is 30 patients.||||0.0001
74055769|NCT00656669|147663315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7963||||||a priori threshold of \<0.05|t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of paxlitaxel+sunitinib treatment||||||0.7963
73881650|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.95||0.089|TWO_SIDED|95.0|-3.49|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.25|-3.49|0.0890
74055770|NCT03778021|147663318|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.093||0.017|TWO_SIDED|95.0|0.04|0.41||"Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05."|Mixed Models Analysis|Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.|Estimated differential change (intervention minus control) from repeated measures linear mixed model|"The unit of measure is score on a scale. The results show the least squares estimate of change in that score, from baseline to 8-month follow-up in each group from model.~Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model."|"In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured)."|0.41|0.04|0.017
74055771|NCT03778021|147663319|SUPERIORITY||Mean Difference (Net)|1.41||||0.18|TWO_SIDED|95.0|-0.66|3.49||"Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05"|Mixed Models Analysis|Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.|Estimated differential change from baseline to follow-up from model (intervention minus control)|"Results present estimated change in score from baseline to 8-month follow-up in each group from model.~Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model."|In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools|3.49|-0.66|0.18
74055772|NCT03778021|147663320|SUPERIORITY||Odds Ratio (OR)|1.29||||0.51|TWO_SIDED|95.0|0.6|2.81||"Repeated measures generalized linear mixed model with binomial distribution (variable was I know I can - yes versus no)."|Mixed Models Analysis|The odds of the odds ratio is reported as the intervention effect.|Odds ratio from estimated least squares from generalized mixed model with binomial distribution specified. Intervention odds of change compared to comparison group odds of change via odds ratio..|"Odds ratio of 8-month follow-up to baseline percent reporting  I know I can was estimated from repeated measures generalized linear mixed model with binomial distribution.~Values included from the 100 and 194 baseline respondents and from the 72 and 141 8-month follow-up respondents of intervention and comparison groups respectively. The person-timepoint is the unit of analysis."||2.81|0.60|0.51
74055773|NCT01545375|147663321|SUPERIORITY|The objective was to demonstrate that VE induced by GSK2189242A vaccine (three doses in the first year of life and a booster dose in the second year of life)in preventing clinical AOM diagnosed and verified against AAP criteria was greater than 0%, as compared to the control group. One-sided p-value for the Wald-Test obtained from the general Cox proportional hazard model was calculated.|Vaccine Efficacy|3.81||||0.3016|TWO_SIDED|95.0|-11.35|16.9||The primary objective was met if the one-sided p-value calculated for the null hypothesis H0=\[clinical AOM VE ≤ 0%\] was lower than defined 1-sided alpha level: (17.8%).|Regression, Cox|||VE-AOM against AAP criteria: Occurrence of AOM during efficacy follow-up period was compared between groups to estimate Vaccine Efficacy (VE) and its 95% confidence interval using the Anderson \& Gill model (generalization of Cox proportional hazard model) taking into account for recurrent events \[Kelly, 2000\]. VE= (1 - hazard ratio) x 100 Censoring occurred at the time of the last scheduled or medically attended visit.||16.90|-11.35|0.3016
74055774|NCT02558634|147663358|SUPERIORITY||Median Difference (Final Values)|1.25||||0.025|TWO_SIDED|95.0|0.75|1.75||The level of significance was set at p=0.025 to allow a Bonferroni correction for these two tests (i.e. p=0.050 divided by two).|Wilcoxon (Mann-Whitney)|||||1.75|0.75|0.025
74055775|NCT00798161|147663369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.79|-0.36||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.36|-0.79|<0.0001
74055776|NCT00798161|147663369|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.73|-0.3||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.30|-0.73|<0.0001
74055777|NCT00798161|147663369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.99|-0.55||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.55|-0.99|<0.0001
74055778|NCT00798161|147663369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.36|-0.92||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.92|-1.36|<0.0001
74100379|NCT04414345|147750114|SUPERIORITY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.766||0.657|TWO_SIDED|95.0|-4.25|2.68|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|CNM-Au8 24-week change from baseline relative to placebo 24-week change from baseline.|||2.68|-4.25|0.6570
74100380|NCT04414345|147750115|SUPERIORITY||Mean Difference (Net)|-3.1|STANDARD_ERROR_OF_MEAN|3.403||0.3621|TWO_SIDED|95.0|-9.78|3.58|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|CNM-Au8 24-week change from baseline relative to placebo 24-week change from baseline.|||3.58|-9.78|0.3621
74100381|NCT04414345|147750116|SUPERIORITY|||||||0.7398|||||||Log Rank|||||||0.7398
74055779|NCT00798161|147663370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.56|-0.26|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.26|-0.56|<0.0001
74055780|NCT00798161|147663370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.53|-0.23|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.23|-0.53|<0.0001
74055781|NCT00798161|147663370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.65|-0.35|||ANCOVA|||Linagliptin 5mg vs Linagliptin 2.5mg with metformin 500mg||-0.35|-0.65|<0.0001
74055782|NCT00798161|147663370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.79|-0.48|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.48|-0.79|<0.0001
74055783|NCT00798161|147663371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.72|-0.31|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.31|-0.72|<0.0001
74055784|NCT00798161|147663371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.63|-0.22|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.22|-0.63|<0.0001
74055785|NCT00798161|147663371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.92|-0.51|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.51|-0.92|<0.0001
74055786|NCT00798161|147663371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.16|-0.75|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.75|-1.16|<0.0001
74055787|NCT00798161|147663372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.73|-0.29|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.29|-0.73|<0.0001
74055788|NCT00798161|147663372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.69|-0.26|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.26|-0.69|<0.0001
74055789|NCT00798161|147663372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.94|-0.49|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.49|-0.94|<0.0001
74055790|NCT00798161|147663372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.3|-0.86|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.86|-1.30|<0.0001
74055791|NCT00798161|147663373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|STANDARD_ERROR_OF_MEAN|5.0||0.0005||95.0|-27.2|-7.6|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-7.6|-27.2|0.0005
74055792|NCT00798161|147663373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|STANDARD_ERROR_OF_MEAN|5.0||0.0006||95.0|-27.1|-7.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-7.3|-27.1|0.0006
74055793|NCT00798161|147663373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.6|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001||95.0|-34.4|-14.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-14.8|-34.4|<0.0001
74055794|NCT00798161|147663373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001||95.0|-50.6|-31.0|||ANCOVA|||Linagliptin 5mg vs. linagliptin 2.5mg with metformin 1000mg||-31.0|-50.6|<0.0001
74055795|NCT00798161|147663374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|4.1||0.0003||95.0|-22.9|-6.8|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-6.8|-22.9|0.0003
74055796|NCT00798161|147663374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-24.9|-8.8|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.8|-24.9|<0.0001
74055797|NCT00798161|147663374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-29.5|-13.4|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-13.4|-29.5|<0.0001
74055798|NCT00798161|147663374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-33.6|-17.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-17.6|-33.6|<0.0001
74055799|NCT00798161|147663375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-26.7|-9.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-9.1|-26.7|<0.0001
74055800|NCT00798161|147663375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.5||0.0002||95.0|-25.6|-7.9|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-7.9|-25.6|0.0002
74055801|NCT00798161|147663375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.9|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-36.7|-19.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-19.1|-36.7|<0.0001
74055802|NCT00798161|147663375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-46.4|-28.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-28.8|-46.4|<0.0001
74055803|NCT00798161|147663376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|STANDARD_ERROR_OF_MEAN|4.7||0.0024||95.0|-23.7|-5.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-5.1|-23.7|0.0024
74055804|NCT00798161|147663376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.0|STANDARD_ERROR_OF_MEAN|4.8||0.0002||95.0|-27.4|-8.7|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.7|-27.4|0.0002
74055805|NCT00798161|147663376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.8|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001||95.0|-37.1|-18.5|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-18.5|-37.1|<0.0001
74055806|NCT00798161|147663376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.5|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001||95.0|-50.8|-32.2|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-32.2|-50.8|<0.0001
74055807|NCT00798161|147663377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001||95.0|-30.4|-11.4|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-11.4|-30.4|<0.0001
74055808|NCT00798161|147663377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|4.9||0.0003||95.0|-27.4|-8.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.3|-27.4|0.0003
74055809|NCT00798161|147663377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|-35.0|-15.9|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-15.9|-35.0|<0.0001
73881651|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.95||0.1444|TWO_SIDED|95.0|-3.25|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.48|-3.25|0.1444
74055810|NCT00798161|147663377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.0|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|-48.5|-29.4|||ANCOVA|||Linagliptin 5 mg vs. Linagliptin 2.5 mg with Metformin 1000 mg||-29.4|-48.5|<0.0001
74100382|NCT01266031|147750126|SUPERIORITY_OR_OTHER|||||||0.26||||||Null hypothesis is: PFS 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.|Chi-squared|||Null hypothesis is: progression free survival (PFS) 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.||||0.26
74100383|NCT00447876|147750173|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.2|||=|0.182|TWO_SIDED|95.0|-0.06|0.46|||Fisher Exact|||The responders rate at Week 6 was compared between treatment groups by a two-sided Fisher exact test.||0.46|-0.06|=0.182
74055811|NCT00798161|147663378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.0062||95.0|1.278|4.402|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||4.402|1.278|0.0062
74055812|NCT00798161|147663378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.163|||<|0.0001||95.0|2.343|7.397|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||7.397|2.343|<0.0001
74055813|NCT00798161|147663378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.854|||<|0.0001||95.0|2.363|9.973|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||9.973|2.363|<0.0001
74055814|NCT00798161|147663378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.094|||<|0.0001||95.0|8.238|35.471|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||35.471|8.238|<0.0001
74055815|NCT00798161|147663380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.465||||0.0102||95.0|1.342|8.943|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||8.943|1.342|0.0102
74100384|NCT00447876|147750174|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.222|||||||Cochran-Mantel-Haenszel|||Gerbershagen's Global scores were compared at Week 18 using a Cochran-Mantel-Haenszel analysis of variance statistic with adjustment to the baseline score.||||=0.222
74100385|NCT00447876|147750176|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.837|||=|0.423|TWO_SIDED|95.0|-30.94|13.266|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect analysis of covariance (ANCOVA) taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||13.266|-30.940|=0.423
74055816|NCT00798161|147663380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.521||||0.0004||95.0|1.747|7.094|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||7.094|1.747|0.0004
74100386|NCT00447876|147750178|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.173|||=|0.682|TWO_SIDED|95.0|-24.64|16.294|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||16.294|-24.640|=0.682
74100387|NCT00447876|147750180|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.066|||=|0.438|TWO_SIDED|95.0|-28.91|12.779|||ANCOVA|||The sum of pain threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||12.779|-28.910|=0.438
74100388|NCT00447876|147750182|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.594|||=|0.937|TWO_SIDED|95.0|-14.575|15.762|||ANCOVA|||The sum of pressure threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||15.762|-14.575|=0.937
74100389|NCT00447876|147750183|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||=|0.8|TWO_SIDED|95.0|-6.8|5.3||The difference (most affected side - control side) in ROM for the dorsal extension was analyzed using a fixed effect ANCOVA, using Week 18 results as the dependent variable and baseline value as covariate.|ANCOVA|||||5.3|-6.8|=0.800
74100390|NCT00447876|147750184|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.862|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.862
73888178|NCT01746901|147309541|SUPERIORITY_OR_OTHER||LS Mean Difference|28.2|||<|0.0001|TWO_SIDED|95.0|16.8|39.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.6|16.8|<0.0001
74055817|NCT00798161|147663380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.521||||0.0053||95.0|1.564|13.069|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||13.069|1.564|0.0053
74055818|NCT00798161|147663380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.947|||<|0.0001||95.0|4.314|33.08|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||33.080|4.314|<0.0001
74055819|NCT00798161|147663382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.181|||<|0.0001||95.0|1.903|5.316|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||5.316|1.903|<0.0001
74055820|NCT00798161|147663382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.382||||0.0027||95.0|1.352|4.196|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||4.196|1.352|0.0027
74055821|NCT00798161|147663382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.622|||<|0.0001||95.0|2.153|6.093|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||6.093|2.153|<0.0001
74100391|NCT00447876|147750184|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.317|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.317
74100392|NCT00447876|147750184|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.525|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.525
74100393|NCT00447876|147750184|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.931|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.931
74100394|NCT00447876|147750184|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.353|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.353
74100395|NCT00447876|147750185|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.882|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.882
74100396|NCT00447876|147750185|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.489|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.489
74055822|NCT00798161|147663382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.529|||<|0.0001||95.0|3.724|11.445|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||11.445|3.724|<0.0001
74100397|NCT00447876|147750185|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.66|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.660
74100398|NCT00447876|147750185|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.485|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.485
74100399|NCT00447876|147750185|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.392|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.392
74100400|NCT01256944|147750186|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74100401|NCT01256944|147750187|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74100402|NCT01256944|147750188|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74100403|NCT01256944|147750190|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74100404|NCT01256944|147750191|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74100405|NCT01256944|147750192|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74100406|NCT01256944|147750193|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74100407|NCT01256944|147750195|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74100408|NCT01256944|147750196|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74100409|NCT00005957|147750197|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.38|TWO_SIDED|95.0|0.72|1.13|||Log Rank||Hazard ratio (HR) estimation is for Standard Breast Irradiation arm versus Breast Radiation plus regional radiation arm.|It was estimated that the actuarial five year survival of patients on the control arm of this trial would be 80% and a 5% increase in five year survival with experiment arm is clinically interesting to detect. A sample size of 1832 will ensure 80% power to detect such a difference with two-sided alpha of 0.05.||1.13|0.72|0.38
74100410|NCT00005957|147750198|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.01|TWO_SIDED|95.0|0.61|0.94|||Log Rank|||||0.94|0.61|0.01
74055823|NCT00798161|147663383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|22.7||0.8893||95.0|-48.5|42.2|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||42.2|-48.5|0.8893
74055824|NCT00798161|147663383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.0|STANDARD_ERROR_OF_MEAN|22.1||0.3234||95.0|-66.2|22.2|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||22.2|-66.2|0.3234
74100411|NCT02952586|147750213|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.9199|TWO_SIDED|95.0|0.928|1.573||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.573|0.928|0.9199
74100412|NCT02952586|147750214|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.9372|TWO_SIDED|95.0|0.927|1.849||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.849|0.927|0.9372
73881652|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.97||0.1022|TWO_SIDED|95.0|-3.51|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.32|-3.51|0.1022
74055825|NCT00798161|147663383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.8|STANDARD_ERROR_OF_MEAN|23.8||0.0373||95.0|-98.5|-3.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-3.1|-98.5|0.0373
74055826|NCT00798161|147663383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-73.9|STANDARD_ERROR_OF_MEAN|22.7||0.0018||95.0|-119.3|-28.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-28.6|-119.3|0.0018
74055827|NCT00798161|147663386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.326||||0.0445|TWO_SIDED|95.0|0.109|0.973|||Regression, Logistic|||||0.973|0.109|0.0445
74055828|NCT00798161|147663386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.274||||0.0151|TWO_SIDED|95.0|0.096|0.779|||Regression, Logistic|||||0.779|0.096|0.0151
74100413|NCT02952586|147750216|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.9316|TWO_SIDED|95.0|0.93|1.694||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.694|0.930|0.9316
74055829|NCT00798161|147663386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.049|TWO_SIDED|95.0|0.177|0.996|||Regression, Logistic|||||0.996|0.177|0.0490
74055830|NCT00798161|147663386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.598||||0.2617|TWO_SIDED|95.0|0.244|1.467|||Regression, Logistic|||||1.467|0.244|0.2617
74055831|NCT01224171|147663443|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.0||||0.4332|TWO_SIDED|95.0|-4.5|10.5|||Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|Clinical remission was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level with stratification according to concomitant use of oral corticosteroids and concomitant use of immunomodulators (6-mercaptopurine \[6-MP\], azathioprine, or methotrexate) for the TNFα antagonist failure subpopulation.||10.5|-4.5|0.4332
74055832|NCT03737812|147663452|OTHER|a statistical test was not performed|Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.485|10.259||||||Analyzed using a logistic regression model with corresponding baseline value as a covariate and treatment as a main effect. Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||10.259|0.485|
74055833|NCT03737812|147663452|OTHER|a statistical test was not performed|Odds Ratio (OR)|3.859|||||TWO_SIDED|95.0|0.899|16.561||||||Analyzed using a logistic regression model with corresponding baseline value as a covariate and treatment as a main effect. Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||16.561|0.899|
74055834|NCT04140942|147663471|SUPERIORITY|||||||0.15|||||||Chi-squared|||6-Month Employment||||.15
74055835|NCT04140942|147663471|SUPERIORITY|||||||0.001|||||||Regression, Logistic|||6-Month Employment||||.001
74055836|NCT04140942|147663471|SUPERIORITY|||||||0.87|||||||Chi-squared|||12-Month Employment||||.87
74055837|NCT04140942|147663472|SUPERIORITY|||||||0.04|||||||ANCOVA|Repeated measures.||||||0.04
74100414|NCT02952586|147750217|SUPERIORITY||Odds Ratio (OR)|0.947||||0.6229|TWO_SIDED|95.0|0.663|1.352||The treatment arms were compared using a stratified, 1-sided, Cochran-Mantel-Haenszel Test. The 3 stratification factors were tumor stage (\< T4 vs T4), Nodal stage (N0 /N1/N2a/N2b vs N2c/N3), HPV status (Positive vs Negative).|Cochran-Mantel-Haenszel|||||1.352|0.663|0.6229
74055838|NCT04140942|147663473|SUPERIORITY|||||||0.056|||||||Chi-squared|||12-Month Recidivism Analysis||||.056
74055839|NCT04140942|147663473|SUPERIORITY|||||||0.18|||||||Chi-squared|||6-Month Recidivism Analysis||||.18
74055840|NCT02918968|147663504|SUPERIORITY|The significance level was 0.05 (two-sided).|Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.29|0.61||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank||Hazard ratio and P-value calculated using unstratified Cox proportional hazards model with treatment and disease stages (M0/N0, M0/N1, or M1) as covariate.|||0.61|0.29|<0.001
74055841|NCT02918968|147663506|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|37.8|||<|0.001|TWO_SIDED|95.0|25.2|50.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate.|\>=50% reduction||50.4|25.2|<0.001
74055842|NCT02918968|147663506|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|38.4|||<|0.001|TWO_SIDED|95.0|26.3|50.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate|≥ 90% reduction||50.4|26.3|<0.001
74055843|NCT02918968|147663507|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|40.7|||<|0.001|TWO_SIDED|95.0|28.3|53.1||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate.|≥ 50% reduction||53.1|28.3|<0.001
74055844|NCT02918968|147663507|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|33.5|||<|0.001|TWO_SIDED|95.0|21.5|45.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate|≥90% reduction||45.4|21.5|<0.001
74055845|NCT02918968|147663508|SUPERIORITY|The significance level was 0.05 (two-sided).|||||<|0.001||||||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank|||||||<0.001
74055846|NCT02918968|147663509|SUPERIORITY|The significance level was 0.05 (two-sided).|||||<|0.001||||||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank|||||||<0.001
74055847|NCT02918968|147663511|SUPERIORITY|The significance level was 0.05 (two-sided).|Hazard Ratio (HR)|0.87||||0.669|TWO_SIDED|95.0|0.45|1.67||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1)|Log Rank||Hazard ratio and P-value calculated using unstratified Cox proportional hazards model with treatment and disease stages (M0/N0, M0/N1, or M1) as covariate.|||1.67|0.45|0.669
73881653|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.97||0.2342|TWO_SIDED|95.0|-3.07|0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.75|-3.07|0.2342
74100415|NCT02952586|147750218|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.9061|TWO_SIDED|95.0|0.909|1.624||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor stage (\< T4 vs T4), Nodal stage (N0 /N1/N2a/N2b vs N2c/N3), HPV status (Positive vs Negative).|Log Rank|||||1.624|0.909|0.9061
73881654|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.96||0.9906|TWO_SIDED|95.0|-1.89|1.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||1.87|-1.89|0.9906
74055848|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055849|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055850|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055851|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74055852|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74055853|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74055854|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74055855|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74055856|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74055857|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74055858|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74055859|NCT03781167|147663613|SUPERIORITY|Week 26 vs Baseline|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74055860|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74055861|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74055862|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74055863|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74055864|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74055865|NCT03781167|147663613|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74055866|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||>|0.999|||||||paired-sample t-test|||Week 1 vs Baseline||||>0.999
74055867|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.5095|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.5095
74055868|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.6962|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.6962
74055869|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0035|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0035
74055870|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0324|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0324
74055871|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74055872|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0072|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0072
73881655|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.95||0.577|TWO_SIDED|95.0|-1.34|2.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||2.40|-1.34|0.5770
73881656|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.95||0.1865|TWO_SIDED|95.0|-3.14|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.61|-3.14|0.1865
74055873|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0129|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0129
74055874|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74055875|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0119|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0119
74100416|NCT01307748|147750302|OTHER|||||||0.005||||||The p value was adjusted for multiple comparisons using false discovery rate.|ANCOVA|Repeated-measures ANOVA with time (stress, post-stress) as a within factor and aroma (lavender, coconut, water) as a between-group factor was used.||The null hypothesis stated that there were no differences between the groups in cortisol level trajectory over time.||||.005
74100417|NCT01307748|147750304|OTHER|||||||0.01||||||P value was adjusted for multiple comparisons using false discovery rate|ANCOVA|A 3 (lavender, coconut, water) by 2 ( prime, no prime) Analysis of Covariance (ANCOVA), with years of education as a covariate was used.||||||.01
74100418|NCT03597464|147750309|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.3||||0.004|TWO_SIDED|95.0|1.3|4.05|||Regression, Logistic|||Month 12 (AURORA 2 baseline)||4.05|1.30|0.004
73881657|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.4575|TWO_SIDED|95.0|-1.45|0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.65|-1.45|0.4575
74055876|NCT03781167|147663614|SUPERIORITY||||||=|0.22||||||A paired-sample t-test was performed to test the change from Baseline.|paired-sample t-test|||Week 26 vs Baseline||||=0.2200
74055877|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0063|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0063
74055878|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74055879|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4331|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.4331
74055880|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0045|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.0045
74055881|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0049|||||||Wilcoxon (Mann-Whitney)|||Week 52 vs Baseline||||=0.0049
74055882|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.6312|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.6312
74055883|NCT03781167|147663614|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1892|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.1892
74100419|NCT03597464|147750309|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.19||||0.006|TWO_SIDED|95.0|1.25|3.83|||Regression, Logistic|||Month 18||3.83|1.25|0.006
74100420|NCT03597464|147750309|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.81||||0.035|TWO_SIDED|95.0|1.04|3.16|||Regression, Logistic|||Month 24||3.16|1.04|0.035
74100421|NCT03597464|147750309|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.24||||0.005|TWO_SIDED|95.0|1.28|3.92|||Regression, Logistic|||Month 30||3.92|1.28|0.005
74100422|NCT03597464|147750309|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.74||||0.051|TWO_SIDED|95.0|1.0|3.03|||Regression, Logistic|||Month 36||3.03|1.00|0.051
74100423|NCT03597464|147750310|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|3.99|||<|0.001|TWO_SIDED|95.0|1.88|8.46|||Regression, Logistic|||Month 12 (AURORA 2 baseline)||8.46|1.88|<0.001
73888179|NCT01746901|147309541|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4||||0.1421|TWO_SIDED|95.0|-2.8|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.6|-2.8|0.1421
74055884|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055885|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055886|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055887|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74055888|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74055889|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74055890|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74055891|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74055892|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74055893|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74100424|NCT03597464|147750310|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.5||||0.008|TWO_SIDED|95.0|1.28|4.88|||Regression, Logistic|||Month 18||4.88|1.28|0.008
74100425|NCT03597464|147750310|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.68||||0.001|TWO_SIDED|95.0|1.46|4.91|||Regression, Logistic|||Month 24||4.91|1.46|0.001
74100426|NCT03597464|147750310|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.86||||0.04|TWO_SIDED|95.0|1.03|3.34|||Regression, Logistic|||Month 30||3.34|1.03|0.040
74100427|NCT03597464|147750310|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.39||||0.29|TWO_SIDED|95.0|0.75|2.58|||Regression, Logistic|||Month 36||2.58|0.75|0.290
74100428|NCT03597464|147750311|OTHER||Odds Ratio (OR)|0.56||||0.045|TWO_SIDED|95.0|0.32|0.99|||Regression, Logistic|||Number of subjects with adequate renal response. This model is based on a logistic regression with terms for treatment, baseline urine protein creatinine ratio (UPCR), biopsy class, mycophenolate mofetil (MMF) use at baseline and region. An odds ratio \< unity indicates benefit for voclosporin.||0.99|0.32|0.045
74055894|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74055895|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74055896|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74055897|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74055898|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74055899|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74055900|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74055901|NCT03781167|147663615|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74100429|NCT03597464|147750312|SUPERIORITY||Least Squares Mean difference|-0.8||||0.238|TWO_SIDED|95.0|-2.1|0.5|||Mixed Models Analysis|||Month 18||0.5|-2.1|0.238
74100430|NCT03597464|147750312|SUPERIORITY||Least Squares Mean difference|-0.7||||0.215|TWO_SIDED|95.0|-1.8|0.4|||Mixed Models Analysis|||Month 24||0.4|-1.8|0.215
74100431|NCT03597464|147750312|SUPERIORITY||Least Squares Mean difference|-0.7||||0.246|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|||Month 36||0.5|-1.8|0.246
74100432|NCT03597464|147750313|SUPERIORITY||Least Squares Mean difference|-0.65||||0.001|TWO_SIDED|95.0|-1.05|-0.26|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-0.26|-1.05|0.001
73881658|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6016|TWO_SIDED|95.0|-1.33|0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.77|-1.33|0.6016
74100433|NCT03597464|147750313|SUPERIORITY||Least Squares Mean difference|-0.63||||0.029|TWO_SIDED|95.0|-1.2|-0.07|||Mixed Models Analysis|||Month 18||-0.07|-1.20|0.029
74100434|NCT03597464|147750313|SUPERIORITY||Least Squares Mean difference|-0.77||||0.002|TWO_SIDED|95.0|-1.24|-0.29|||Mixed Models Analysis|||Month 24||-0.29|-1.24|0.002
74055902|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
74055903|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
74055904|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
74055905|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055906|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055907|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055908|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
74055909|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
74055910|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
74100435|NCT03597464|147750313|SUPERIORITY||Least Squares Mean difference|-0.91||||0.002|TWO_SIDED|95.0|-1.49|-0.33|||Mixed Models Analysis|||Month 30||-0.33|-1.49|0.002
74100436|NCT03597464|147750313|SUPERIORITY||Least Squares Mean difference|-0.48||||0.106|TWO_SIDED|95.0|-1.06|-0.1|||Mixed Models Analysis|||Month 36||-0.10|-1.06|0.106
74100437|NCT03597464|147750314|SUPERIORITY||Least Squares Mean difference|-2.7||||0.041|TWO_SIDED|95.0|-5.3|-0.1|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-0.1|-5.3|0.041
74055911|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
74100438|NCT03597464|147750314|SUPERIORITY||Least Squares Mean difference|-1.8||||0.292|TWO_SIDED|95.0|-5.1|1.6|||Mixed Models Analysis|||Month 18||1.6|-5.1|0.292
74055912|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
74055913|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
74055914|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0042|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0042
74055915|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
74055916|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
74055917|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1135|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.1135
74055918|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0029|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0029
74055919|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0026|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0026
74055920|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0034|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0034
74055921|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0103|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0103
74055922|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74055923|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0493|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0493
74055924|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3003|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.3003
74055925|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0354|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0354
74055926|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2553|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.2553
74100439|NCT03597464|147750314|SUPERIORITY||Least Squares Mean difference|-2.2||||0.282|TWO_SIDED|95.0|-6.1|1.8|||Mixed Models Analysis|||Month 24||1.8|-6.1|0.282
74055927|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.864|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.8640
74055928|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4774|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.4774
74055929|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3865|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.3865
74055930|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.||||||0.1186|||||||paired-sample t-test|||Week 52 vs Baseline||||0.1186
74055931|NCT03781167|147663616|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.083|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0830
74055932|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
74055933|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0041|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.0041
74055934|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
74055935|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055936|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055937|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055938|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
74055939|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
74055940|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
74055941|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
74055942|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
74055943|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
74055944|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
74055945|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
74100440|NCT03597464|147750314|SUPERIORITY||Least Squares Mean difference|0.9||||0.659|TWO_SIDED|95.0|-3.2|5.1|||Mixed Models Analysis|||Month 30||5.1|-3.2|0.659
74100441|NCT03597464|147750314|SUPERIORITY||Least Squares Mean difference|1.8||||0.438|TWO_SIDED|95.0|-2.8|6.4|||Mixed Models Analysis|||Month 36||6.4|-2.8|0.438
73881659|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7026|TWO_SIDED|95.0|-0.86|1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||1.28|-0.86|0.7026
73881660|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.2971|TWO_SIDED|95.0|-1.64|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.50|-1.64|0.2971
74055946|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
74055947|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74055948|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74055949|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74055950|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74055951|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74055952|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74055953|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74055954|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74055955|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74055956|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74055957|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74055958|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74055959|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0091|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0091
74055960|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74055961|NCT03781167|147663617|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74055962|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4447|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.4447
74055963|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3567|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.3567
74055964|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2315|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.2315
74055965|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0667|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.0667
74055966|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055967|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055968|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
74055969|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2033|||||||paired-sample t-test|||Week 2 vs Baseline||||=0.2033
74055970|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
74055971|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0012|||||||paired-sample t-test|||Week 3 vs Baseline||||=0.0012
74055972|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0734|||||||paired-sample t-test|||Week 3 vs Baseline||||=0.0734
74055973|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
74055974|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0304|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0304
74055975|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||>|0.999|||||||paired-sample t-test|||Week 4 vs Baseline||||>0.999
74055976|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0891|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0891
73881661|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.54||0.5491|TWO_SIDED|95.0|-1.38|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.74|-1.38|0.5491
74055977|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0832|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0832
74055978|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4941|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.4941
74055979|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2764|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.2764
74055980|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3248|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.3248
74055981|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2535|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.2535
74055982|NCT03781167|147663618|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.9274|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.9274
74055983|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3297|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.3297
74055984|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.9722|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.9722
74055985|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4403|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.4403
74055986|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1946|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.1946
74055987|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2077|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.2077
74055988|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0692|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.0692
74055989|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2276|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.2276
74100442|NCT03597464|147750315|SUPERIORITY||Least Squares Mean difference|-67.7||||0.002|TWO_SIDED|95.0|-110.4|-25.1|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-25.1|-110.4|0.002
74100443|NCT03597464|147750315|SUPERIORITY||Least Squares Mean difference|-87.7||||0.007|TWO_SIDED|95.0|-151.2|-24.2|||Mixed Models Analysis|||Month 18||-24.2|-151.2|0.007
73881662|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7142|TWO_SIDED|95.0|-0.86|1.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||1.25|-0.86|0.7142
74055990|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.||||||0.3369|||||||paired-sample t-test|||Week 52 vs Baseline||||0.3369
74055991|NCT03781167|147663618|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1218|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.1218
74055992|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
74055993|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.002|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.0020
74055994|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055995|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055996|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
74055997|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
74055998|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
74055999|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
74056000|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
74056001|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
74056002|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
74056003|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
74056004|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
74056005|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
74056006|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
74100444|NCT03597464|147750315|SUPERIORITY||Least Squares Mean difference|-47.0||||0.035|TWO_SIDED|95.0|-90.8|-3.3|||Mixed Models Analysis|||Month 24||-3.3|-90.8|0.035
74100445|NCT03597464|147750315|SUPERIORITY||Least Squares Mean difference|-73.1||||0.005|TWO_SIDED|95.0|-123.5|-22.6|||Mixed Models Analysis|||Month 30||-22.6|-123.5|0.005
74100446|NCT03597464|147750315|SUPERIORITY||Least Squares Mean difference|-19.0||||0.537|TWO_SIDED|95.0|-79.7|41.7|||Mixed Models Analysis|||Month 36||41.7|-79.7|0.537
74056007|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
73881663|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.53||0.1157|TWO_SIDED|95.0|-1.89|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.21|-1.89|0.1157
74056008|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74056009|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74056010|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74056011|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74056012|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74056013|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74056014|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74056015|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74056016|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056017|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056018|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056019|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
73881664|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.36||0.1114|TWO_SIDED|95.0|-1.3|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||0.14|-1.30|0.1114
74056020|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74056021|NCT03781167|147663619|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74056022|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74056023|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74056024|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74056025|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74056026|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74056027|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74056028|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74056029|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74056030|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74056031|NCT03781167|147663620|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056032|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056033|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056034|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74056035|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74056036|NCT03781167|147663620|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74056037|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74056038|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74056039|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74056040|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74056041|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74056042|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74056043|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74100447|NCT03597464|147750316|SUPERIORITY||Least Squares Mean difference|0.084|||<|0.001|TWO_SIDED|95.0|0.035|0.134|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||0.134|0.035|<0.001
74100448|NCT03597464|147750316|SUPERIORITY||Least Squares Mean difference|0.051||||0.209|TWO_SIDED|95.0|-0.029|0.131|||Mixed Models Analysis|||Month 18||0.131|-0.029|0.209
74100449|NCT03597464|147750316|SUPERIORITY||Least Squares Mean difference|0.057||||0.353|TWO_SIDED|95.0|-0.064|0.178|||Mixed Models Analysis|||Month 24||0.178|-0.064|0.353
74100450|NCT03597464|147750316|SUPERIORITY||Least Squares Mean difference|-0.036||||0.616|TWO_SIDED|95.0|-0.176|0.105|||Mixed Models Analysis|||Month 30||0.105|-0.176|0.616
73881665|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.36||0.0025|TWO_SIDED|95.0|-1.83|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.40|-1.83|0.0025
73881666|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.2|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Scre||-0.74|-2.20|<0.0001
74056044|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74056045|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74056046|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056047|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056048|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056049|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74056050|NCT03781167|147663621|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74056051|NCT03781167|147663621|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74056052|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0035|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0035
74056053|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74056054|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
74056055|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0098|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0098
74056056|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74056057|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
74056058|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74056059|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74100451|NCT03597464|147750316|SUPERIORITY||Least Squares Mean difference|-0.077||||0.372|TWO_SIDED|95.0|-0.248|0.094|||Mixed Models Analysis|||Month 36||0.094|-0.248|0.372
74100452|NCT02682927|147750340|SUPERIORITY||Percentage difference from Placebo|62.29|||||TWO_SIDED|95.0|47.72|72.8|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||72.80|47.72|
74100453|NCT02682927|147750340|SUPERIORITY||Percentage difference from Placebo|64.75|||||TWO_SIDED|95.0|51.85|74.19|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||74.19|51.85|
74100454|NCT02682927|147750341|SUPERIORITY||Percentage difference from Placebo|32.43|||||TWO_SIDED|95.0|6.19|51.33|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||51.33|6.19|
74100455|NCT02682927|147750341|SUPERIORITY||Percentage difference from Placebo|49.88|||||TWO_SIDED|95.0|31.31|63.43|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||63.43|31.31|
74100456|NCT02682927|147750343|SUPERIORITY||Odds Ratio (OR)|4.773||||0.009|TWO_SIDED|95.0|1.475|15.45|||Regression, Logistic|||||15.450|1.475|0.009
74056060|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
74056061|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056062|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056063|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
74056064|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.003|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0030
74056065|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74056066|NCT03781167|147663622|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
74056067|NCT00398476|147663644|OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||Analysis for overall product preference||||0.003
74056068|NCT00398476|147663644|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Scent/odor||||<0.001
74056069|NCT00398476|147663644|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Immediate taste||||<0.001
74056070|NCT00398476|147663644|OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|||Analysis for After-taste||||0.002
74056071|NCT00398476|147663644|OTHER|||||||0.037|||||||Cochran-Mantel-Haenszel|||Analysis for Less drip down throat||||0.037
73881667|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.37||0.5093|TWO_SIDED|95.0|-0.96|0.48|||MMRM|||Week 8: Vasomotor Symptoms Score||0.48|-0.96|0.5093
74056072|NCT00398476|147663644|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Less run out nose||||<0.001
74056073|NCT00398476|147663644|OTHER|||||||0.408|||||||Cochran-Mantel-Haenszel|||Analysis for More soothing||||0.408
74056074|NCT00398476|147663644|OTHER|||||||0.07|||||||Cochran-Mantel-Haenszel|||Analysis for Less irritating||||0.070
74056075|NCT00398476|147663644|OTHER|||||||0.587|||||||Cochran-Mantel-Haenszel|||Analysis for Urge to sneeze||||0.587
74056076|NCT00398476|147663645|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-2.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ items||||<0.001
74056077|NCT00398476|147663645|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-1.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ items||||<0.001
74056078|NCT00398476|147663646|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.255||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ||||0.255
74056079|NCT00398476|147663647|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.056||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for all DAQ items||||0.056
74056080|NCT00398476|147663648|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.845||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ Irtems||||0.845
74056081|NCT00398476|147663649|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.871||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ Items||||0.871
74056082|NCT00398476|147663650|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
74056083|NCT00398476|147663651|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.592||95.0|||||Cochran-Mantel-Haenszel|||||||0.592
74056084|NCT00398476|147663652|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
74056085|NCT00398476|147663653|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.434||95.0|||||Cochran-Mantel-Haenszel|||||||0.434
74056086|NCT00398476|147663654|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ||||0.797
74056087|NCT00398476|147663654|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.296|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ||||0.296
74100457|NCT02682927|147750343|SUPERIORITY||Odds Ratio (OR)|14.96|||<|0.001|TWO_SIDED|95.0|4.484|49.915|||Regression, Logistic|||||49.915|4.484|<0.001
74100458|NCT02682927|147750343|SUPERIORITY||Odds Ratio (OR)|13.4||||0.0001|TWO_SIDED|95.0|3.6|49.8|||Regression, Logistic|||||49.8|3.6|0.0001
74100459|NCT02682927|147750343|SUPERIORITY||Odds Ratio (OR)|53.3|||<|0.0001|TWO_SIDED|95.0|12.9|220.5|||Regression, Logistic|||||220.5|12.9|<0.0001
74100460|NCT02682927|147750346|SUPERIORITY|||||||0.035|||||||Wilcoxon rank sum test|||||||0.035
74100461|NCT02682927|147750346|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
74100462|NCT02682927|147750346|SUPERIORITY||Comparing active with placebo|||||0.0002|||||||Wilcoxon rank sum test|||||||0.0002
74100463|NCT02682927|147750346|SUPERIORITY||||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
74100464|NCT02207634|147750425|NON_INFERIORITY|The non-inferiority margin was 0.19, calculated as 20% of the observed common standard deviation, which was estimated from observations in the placebo group by a repeated measured mixed-effect linear model with visit as a covariate. If the upper bound of the 95% CI for the difference between the placebo and evolocumab group in mean change from baseline for Z score averaged across the visits was less than the non-inferiority margin non-inferiority criteria were met.|Treatment Difference|0.0072|STANDARD_ERROR_OF_MEAN|0.0375|||TWO_SIDED|95.0|-0.0664|0.0808||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening low-density lipoprotein cholesterol \[LDL-C\] and geographical region), age, education level, baseline SWM strategy index Z score, treatment group, visit, and treatment by visit interaction.||0.0808|-0.0664|
74100465|NCT02207634|147750426|OTHER||Treatment Difference|0.0333|STANDARD_ERROR_OF_MEAN|0.0363|||TWO_SIDED|95.0|-0.0378|0.1045||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline SWM between-errors Z score, treatment group, visit, and treatment by visit interaction.||0.1045|-0.0378|
74100466|NCT02207634|147750427|OTHER||Treatment Difference|0.0226|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.0422|0.0873||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline PAL total errors adjusted Z score, treatment group, visit, and treatment by visit interaction.||0.0873|-0.0422|
74100467|NCT02207634|147750428|OTHER||Treatment Difference|0.0727|STANDARD_ERROR_OF_MEAN|0.0382|||TWO_SIDED|95.0|-0.0022|0.1477||||||A repeated measures mixed-effect linear model was used to estimate treatment difference ( placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline RTI median 5-choice reaction time Z score, treatment group, visit, and treatment by visit interaction.||0.1477|-0.0022|
74100468|NCT00591773|147750435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.86|||<|0.001|TWO_SIDED|95.0|-18.54|-13.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-13.19|-18.54|<0.001
74100469|NCT00591773|147750435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.45|||<|0.001|TWO_SIDED|95.0|-18.13|-12.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-12.76|-18.13|<0.001
74100470|NCT00591773|147750436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|||<|0.001|TWO_SIDED|95.0|-17.81|-10.99||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-10.99|-17.81|<0.001
74100471|NCT00591773|147750436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.001|TWO_SIDED|95.0|-16.1|-9.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-9.25|-16.10|<0.001
74100472|NCT00591773|147750437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.29|||<|0.001|TWO_SIDED|95.0|-12.02|-8.56||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.56|-12.02|<0.001
74100473|NCT00591773|147750437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.49|||<|0.001|TWO_SIDED|95.0|-12.23|-8.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.76|-12.23|<0.001
74100474|NCT00591773|147750438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.25|||<|0.001|TWO_SIDED|95.0|-9.25|-5.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.25|-9.25|<0.001
74100475|NCT00591773|147750438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||<|0.001|TWO_SIDED|95.0|-9.06|-5.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.05|-9.06|<0.001
74100476|NCT00591773|147750439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.001|TWO_SIDED|95.0|-19.56|-14.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.04|-19.56|<0.001
74100477|NCT00591773|147750439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.24|||<|0.001|TWO_SIDED|95.0|-19.01|-13.47||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-13.47|-19.01|<0.001
74100478|NCT00591773|147750440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02|||<|0.001|TWO_SIDED|95.0|-12.86|-9.18||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.18|-12.86|<0.001
74056088|NCT00398476|147663655|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ||||<0.001
74056089|NCT00398476|147663655|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in DAQ||||<0.001
74056090|NCT00398476|147663656|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.968|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ||||0.968
74056091|NCT00398476|147663656|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Mean Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ||||0.797
74100479|NCT00591773|147750440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.04|-9.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.35|-13.04|<0.001
74100480|NCT00591773|147750441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.93|||<|0.001|TWO_SIDED|95.0|-15.92|-9.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.94|-15.92|<0.001
74100481|NCT00591773|147750441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.84|||<|0.001|TWO_SIDED|95.0|-15.83|-9.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.84|-15.83|<0.001
74100482|NCT00591773|147750442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.16|||<|0.001|TWO_SIDED|95.0|-10.14|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.19|-10.14|<0.001
74100483|NCT00591773|147750442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.17|||<|0.001|TWO_SIDED|95.0|-10.15|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.19|-10.15|<0.001
74100484|NCT00591773|147750443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.52|||<|0.001|TWO_SIDED|95.0|-20.39|-14.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.64|-20.39|<0.001
74100485|NCT00591773|147750443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.95|||<|0.001|TWO_SIDED|95.0|-19.84|-14.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.05|-19.84|<0.001
74100486|NCT00591773|147750444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54|||<|0.001|TWO_SIDED|95.0|-13.49|-9.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.59|-13.49|<0.001
74056092|NCT00398476|147663657|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.221|||||||Cochran-Mantel-Haenszel|||||||0.221
74056093|NCT00398476|147663658|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.205|||||||Cochran-Mantel-Haenszel|||||||0.205
74056094|NCT00398476|147663659|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.108|||||||Cochran-Mantel-Haenszel|||||||0.108
74056095|NCT00398476|147663660|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.694|||||||Cochran-Mantel-Haenszel|||||||0.694
74056096|NCT00398476|147663661|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
74056097|NCT00933543|147663665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.43||||0.0703|TWO_SIDED|95.0|0.65|63.18||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||63.18|0.65|0.0703
74056098|NCT00933543|147663667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.92||||0.2969|TWO_SIDED|95.0|-11.35|3.5||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||3.50|-11.35|0.2969
74100487|NCT00591773|147750444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.68|||<|0.001|TWO_SIDED|95.0|-13.64|-9.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.72|-13.64|<0.001
74100488|NCT00591773|147750445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.04|||<|0.001|TWO_SIDED|95.0|-17.13|-10.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.94|-17.13|<0.001
74100489|NCT00591773|147750445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.48|||<|0.001|TWO_SIDED|95.0|-16.58|-10.37||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.37|-16.58|<0.001
73881668|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.33|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.86|-2.33|<0.0001
74056099|NCT00933543|147663668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.8913|TWO_SIDED|95.0|-9.09|10.43||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||10.43|-9.09|0.8913
74056100|NCT04988035|147663691|SUPERIORITY||Odds Ratio (OR)|0.64||||0.09|TWO_SIDED|95.0|0.38|1.07|||Proportional odds model||Odds ratio greater than 1 favors Remdesivir plus Danicopan.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2.||1.07|0.38|0.090
74056101|NCT04988035|147663692|SUPERIORITY||Odds Ratio (OR)|0.69||||0.358|TWO_SIDED|95.0|0.31|1.53|||Regression, Logistic|||Odds ratio, confidence interval, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline C-Reactive Protein (CRP).|Odds ratio greater than 1 favors Remdesivir plus Danicopan|1.53|0.31|0.358
74056102|NCT04988035|147663693|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.014|TWO_SIDED|95.0|0.46|0.92|||Regression, Cox||HR greater than 1 favors Remdesivir plus Danicopan.|Hazard ratio, confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||0.92|0.46|0.014
74100490|NCT00591773|147750446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.42|||<|0.001|TWO_SIDED|95.0|-11.65|-7.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.20|-11.65|<0.001
74100491|NCT00591773|147750446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.69|||<|0.001|TWO_SIDED|95.0|-11.92|-7.46||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.46|-11.92|<0.001
73881669|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.36||0.009|TWO_SIDED|95.0|-1.67|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.24|-1.67|0.0090
74100492|NCT00591773|147750447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.38|7.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.03|2.38|<0.001
74056103|NCT04988035|147663694|SUPERIORITY||Odds Ratio (OR)|0.7||||0.177|TWO_SIDED|95.0|0.42|1.17|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Danicopan.|Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.17|0.42|0.177
74056104|NCT04988035|147663695|SUPERIORITY||Odds Ratio (OR)|0.81||||0.427|TWO_SIDED|95.0|0.48|1.36|||Proportional odds model|||Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 29 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 29 after discharge are given a score of 2.|Odds ratio above 1 favors Remdesivir plus Danicopan.|1.36|0.48|0.427
74056105|NCT04988035|147663730|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.109|TWO_SIDED|95.0|0.56|1.06|||Regression, Cox||HR greater than 1 favors Remdesivir plus Danicopan.|||1.06|0.56|0.109
74056106|NCT04988035|147663731|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.036|TWO_SIDED|95.0|0.51|0.98|||Regression, Cox||||HR greater than 1 favors Remdesivir plus Danicopan.|0.98|0.51|0.036
74056107|NCT01258803|147663736|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.094|0.154|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an analysis of covariance (ANCOVA) model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.154|0.094|<0.001
74056108|NCT01258803|147663737|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102|||<|0.001|TWO_SIDED|95.0|0.073|0.131|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.131|0.073|<0.001
74056109|NCT01258803|147663738|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.022||||0.144|TWO_SIDED|95.0|-0.008|0.052|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and MF/F MDI without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.052|-0.008|0.144
74056110|NCT01258803|147663740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.018||||0.229|TWO_SIDED|95.0|-0.012|0.048|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.048|-0.012|0.229
74056111|NCT01258803|147663741|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.004||||0.79|TWO_SIDED|95.0|-0.033|0.025|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.025|-0.033|0.790
74056112|NCT01258803|147663742|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.106|||<|0.001|TWO_SIDED|95.0|0.077|0.135|||ANCOVA|||"Pairwise Treatment Comparison of F DPI and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.135|0.077|<0.001
74056113|NCT04652245|147663754|SUPERIORITY|||||||0.028|||||||ANCOVA|||||||0.028
74056114|NCT04652245|147663755|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
74056115|NCT01830621|147663756|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.337|TWO_SIDED|95.0|0.88|1.46|||Log Rank|||||1.46|0.88|0.337
74056116|NCT01830621|147663757|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.837|TWO_SIDED|95.0|0.76|1.26|||Log Rank|||||1.26|0.76|0.837
74056117|NCT01830621|147663758|SUPERIORITY||Odds Ratio (OR)|0.98||||0.955|TWO_SIDED|95.0|0.48|2.0|||Cochran-Mantel-Haenszel|||||2.00|0.48|0.955
74100493|NCT00591773|147750447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.82|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.03|1.82|<0.001
74100494|NCT00591773|147750448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|1.9|7.27||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.27|1.90|<0.001
73888180|NCT01746901|147309541|SUPERIORITY_OR_OTHER||LS Mean Difference|20.9||||0.0004|TWO_SIDED|95.0|9.5|32.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.2|9.5|0.0004
74056118|NCT01830621|147663760|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
74056119|NCT04419558|147663769|OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.077||0.6579|TWO_SIDED|95.0|-0.12|0.19|||Mixed Models Analysis|||||0.19|-0.12|0.6579
74056120|NCT05146999|147663779|SUPERIORITY||Treatment difference|83.8|||<|0.001|TWO_SIDED|95.0|72.81|94.87|||Cochran-Mantel-Haenszel|||||94.87|72.81|<0.001
74056121|NCT05664672|147663788|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.2|||<|0.0001|TWO_SIDED|95.0|15.9|37.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.0|15.9|<.0001
74056122|NCT05664672|147663788|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|25.3|||<|0.0001|TWO_SIDED|95.0|17.1|37.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.3|17.1|<.0001
74056123|NCT05664672|147663788|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.4|||<|0.0001|TWO_SIDED|95.0|14.9|33.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||33.7|14.9|<.0001
74056124|NCT05664672|147663788|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.5|||<|0.0001|TWO_SIDED|95.0|10.8|25.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.3|10.8|<.0001
74056125|NCT05664672|147663788|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|147.0||||0.1148|TWO_SIDED|95.0|93.7|230.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||230|93.7|0.1148
74056126|NCT05664672|147663788|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|153.0||||0.044|TWO_SIDED|95.0|101.0|233.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||233|101|0.0440
74056127|NCT05664672|147663788|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|136.0||||0.2422|TWO_SIDED|95.0|87.8|210.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||210|87.8|0.2422
74056128|NCT05664672|147663789|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|49.9||||0.0994|TWO_SIDED|95.0|22.7|110.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||110|22.7|0.0994
74056129|NCT05664672|147663789|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|65.8||||0.4162|TWO_SIDED|95.0|32.0|135.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||135|32.0|0.4162
74056130|NCT05664672|147663789|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||1|TWO_SIDED|95.0|47.5|215.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||215|47.5|1.0000
74056131|NCT05664672|147663789|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2.23|||<|0.0001|TWO_SIDED|95.0|1.01|4.94|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||4.94|1.01|<.0001
74056132|NCT05664672|147663789|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2230.0|||<|0.0001|TWO_SIDED|95.0|965.0|5160.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||5160|965|<.0001
74056133|NCT05664672|147663789|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2940.0|||<|0.0001|TWO_SIDED|95.0|1350.0|6400.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||6400|1350|<.0001
74056134|NCT05664672|147663789|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4530.0|||<|0.0001|TWO_SIDED|95.0|2020.0|10200.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||10200|2020|<.0001
74056135|NCT05664672|147663790|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.69|||<|0.0001|TWO_SIDED|95.0|3.29|9.87|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||9.87|3.29|<.0001
73881670|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.37||0.0024|TWO_SIDED|95.0|-1.84|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|LSMean difference|||Week 4: Vasomotor Symptoms Score||-0.40|-1.84|0.0024
74056136|NCT05664672|147663790|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|8.08|||<|0.0001|TWO_SIDED|95.0|4.88|13.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||13.4|4.88|<.0001
74056137|NCT05664672|147663790|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.58|||<|0.0001|TWO_SIDED|95.0|3.88|11.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||11.2|3.88|<.0001
74056138|NCT05664672|147663790|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.03|||<|0.0001|TWO_SIDED|95.0|3.46|10.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||10.5|3.46|<.0001
74056139|NCT05664672|147663790|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|94.4||||0.9972|TWO_SIDED|95.0|52.7|169.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||169|52.7|0.9972
74056140|NCT05664672|147663790|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|134.0||||0.4655|TWO_SIDED|95.0|77.9|230.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||230|77.9|0.4655
74056141|NCT05664672|147663790|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|109.0||||0.9851|TWO_SIDED|95.0|62.1|192.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||192|62.1|0.9851
74056142|NCT05664672|147663791|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.7|||<|0.0001|TWO_SIDED|95.0|9.72|19.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||19.2|9.72|<.0001
74056143|NCT05664672|147663791|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.6|||<|0.0001|TWO_SIDED|95.0|12.1|22.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.6|12.1|<.0001
74056144|NCT05664672|147663791|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.4|||<|0.0001|TWO_SIDED|95.0|9.68|18.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.6|9.68|<.0001
74056145|NCT05664672|147663791|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|15.7|||<|0.0001|TWO_SIDED|95.0|11.2|22.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.2|11.2|<.0001
74100495|NCT00591773|147750448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.002|TWO_SIDED|95.0|1.46|5.0||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.00|1.46|0.002
74100496|NCT00591773|147750449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|2.41|6.64||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.64|2.41|<0.001
74100497|NCT00591773|147750449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001|TWO_SIDED|95.0|1.83|4.79||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.79|1.83|<0.001
74100498|NCT02047734|147750450|SUPERIORITY||Rate Ratio|0.623|||<|0.0001|TWO_SIDED|95.0|0.506|0.768||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson regression model|Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.768|0.506|<0.0001
74056146|NCT05664672|147663791|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.8||||0.7167|TWO_SIDED|95.0|60.6|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|60.6|0.7167
74056147|NCT05664672|147663791|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|105.0||||0.9864|TWO_SIDED|95.0|75.3|147.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||147|75.3|0.9864
74056148|NCT05664672|147663791|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|85.1||||0.5911|TWO_SIDED|95.0|60.1|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|60.1|0.5911
74056149|NCT05664672|147663792|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|29.6|||<|0.0001|TWO_SIDED|95.0|21.8|40.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||40.0|21.8|<.0001
74056150|NCT05664672|147663792|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.3|||<|0.0001|TWO_SIDED|95.0|21.5|37.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.4|21.5|<.0001
74056151|NCT05664672|147663792|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|33.1|||<|0.0001|TWO_SIDED|95.0|24.8|44.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||44.2|24.8|<.0001
74056152|NCT05664672|147663792|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|37.5|||<|0.0001|TWO_SIDED|95.0|27.7|50.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||50.9|27.7|<.0001
74056153|NCT05664672|147663792|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|78.8||||0.195|TWO_SIDED|95.0|57.3|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|57.3|0.1950
74056154|NCT05664672|147663792|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|75.5||||0.0699|TWO_SIDED|95.0|56.1|102.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||102|56.1|0.0699
74056155|NCT05664672|147663792|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.3||||0.7041|TWO_SIDED|95.0|64.7|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|64.7|0.7041
74056156|NCT05664672|147663793|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.3|||<|0.0001|TWO_SIDED|95.0|9.57|18.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.4|9.57|<.0001
74056157|NCT05664672|147663793|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.3|||<|0.0001|TWO_SIDED|95.0|9.84|17.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||17.9|9.84|<.0001
74056158|NCT05664672|147663793|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.6|||<|0.0001|TWO_SIDED|95.0|9.93|18.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.6|9.93|<.0001
74056159|NCT05664672|147663793|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|9.28|||<|0.0001|TWO_SIDED|95.0|6.67|12.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||12.9|6.67|<.0001
73881671|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5497|TWO_SIDED|95.0|-0.47|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.25|-0.47|0.5497
73881672|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0276|TWO_SIDED|95.0|-0.76|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||-0.04|-0.76|0.0276
74056160|NCT05664672|147663793|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|143.0||||0.0404|TWO_SIDED|95.0|101.0|202.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||202|101|0.0404
74056161|NCT05664672|147663793|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|143.0||||0.0243|TWO_SIDED|95.0|104.0|198.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||198|104|0.0243
74056162|NCT05664672|147663793|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|146.0||||0.0215|TWO_SIDED|95.0|105.0|205.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||205|105|0.0215
74056163|NCT05664672|147663794|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.37|||<|0.0001|TWO_SIDED|95.0|3.69|7.8|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.80|3.69|<.0001
74056164|NCT05664672|147663794|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.65|||<|0.0001|TWO_SIDED|95.0|4.01|7.96|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.96|4.01|<.0001
74056165|NCT05664672|147663794|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.61|||<|0.0001|TWO_SIDED|95.0|3.92|8.03|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.03|3.92|<.0001
74056166|NCT05664672|147663794|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.09|||<|0.0001|TWO_SIDED|95.0|4.17|8.89|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.89|4.17|<.0001
74056167|NCT05664672|147663794|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.1||||0.8335|TWO_SIDED|95.0|59.4|131.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||131|59.4|0.8335
74056168|NCT05664672|147663794|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|92.9||||0.9622|TWO_SIDED|95.0|64.2|134.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||134|64.2|0.9622
74056169|NCT05664672|147663794|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|92.1||||0.9531|TWO_SIDED|95.0|62.8|135.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||135|62.8|0.9531
74056170|NCT05664672|147663795|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.0|||<|0.0001|TWO_SIDED|95.0|14.4|22.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.3|14.4|<.0001
73881673|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1274|TWO_SIDED|95.0|-0.65|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.08|-0.65|0.1274
73888181|NCT01746901|147309541|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.0064|TWO_SIDED|95.0|4.5|27.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.0|4.5|0.0064
74056171|NCT05664672|147663795|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.0|||<|0.0001|TWO_SIDED|95.0|14.8|22.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.1|14.8|<.0001
74056172|NCT05664672|147663795|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|15.8|||<|0.0001|TWO_SIDED|95.0|12.8|19.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||19.4|12.8|<.0001
74056173|NCT05664672|147663795|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.2|||<|0.0001|TWO_SIDED|95.0|14.6|22.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.7|14.6|<.0001
74056174|NCT05664672|147663795|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.4||||0.9993|TWO_SIDED|95.0|78.2|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|78.2|0.9993
74100499|NCT02047734|147750450|SUPERIORITY||Rate Ratio|0.791||||0.0167|TWO_SIDED|95.0|0.652|0.958||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson Regression Model|Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.958|0.652|0.0167
74056175|NCT05664672|147663795|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.9||||0.9998|TWO_SIDED|95.0|79.7|123.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||123|79.7|0.9998
74056176|NCT05664672|147663795|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.4||||0.3019|TWO_SIDED|95.0|69.1|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|69.1|0.3019
74056177|NCT05664672|147663796|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.3|||<|0.0001|TWO_SIDED|95.0|13.2|25.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.3|13.2|<.0001
74056178|NCT05664672|147663796|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|23.7|||<|0.0001|TWO_SIDED|95.0|17.6|31.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||31.9|17.6|<.0001
74056179|NCT05664672|147663796|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|19.3|||<|0.0001|TWO_SIDED|95.0|14.2|26.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||26.4|14.2|<.0001
74056180|NCT05664672|147663796|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.0|||<|0.0001|TWO_SIDED|95.0|17.3|33.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||33.3|17.3|<.0001
74056181|NCT05664672|147663796|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|76.1||||0.153|TWO_SIDED|95.0|54.0|107.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||107|54.0|0.1530
74056182|NCT05664672|147663796|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.6||||0.9999|TWO_SIDED|95.0|71.7|136.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||136|71.7|0.9999
74056183|NCT05664672|147663796|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|80.5||||0.3025|TWO_SIDED|95.0|57.8|112.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||112|57.8|0.3025
74056184|NCT05664672|147663797|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.7|||<|0.0001|TWO_SIDED|95.0|17.0|30.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||30.4|17.0|<.0001
73881674|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.1865|TWO_SIDED|95.0|-0.61|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|LSMean difference|||Week 8: Sexual Dysfunction Score||0.12|-0.61|0.1865
73888182|NCT01746901|147309541|SUPERIORITY_OR_OTHER||LS Mean Difference|7.4||||0.1974|TWO_SIDED|95.0|-3.9|18.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.6|-3.9|0.1974
74056185|NCT05664672|147663797|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.1|||<|0.0001|TWO_SIDED|95.0|21.6|36.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||36.6|21.6|<.0001
74056186|NCT05664672|147663797|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|27.5|||<|0.0001|TWO_SIDED|95.0|20.8|36.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||36.2|20.8|<.0001
74056187|NCT05664672|147663797|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.7|||<|0.0001|TWO_SIDED|95.0|21.4|38.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||38.4|21.4|<.0001
74056188|NCT05664672|147663797|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|79.4||||0.1843|TWO_SIDED|95.0|58.6|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|58.6|0.1843
74056189|NCT05664672|147663797|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.1||||0.9994|TWO_SIDED|95.0|73.9|130.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||130|73.9|0.9994
74056190|NCT05664672|147663797|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|95.9||||0.9891|TWO_SIDED|95.0|71.4|129.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||129|71.4|0.9891
74056191|NCT05664672|147663798|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|37.3|||<|0.0001|TWO_SIDED|95.0|30.4|45.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||45.7|30.4|<.0001
74056192|NCT05664672|147663798|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|44.0|||<|0.0001|TWO_SIDED|95.0|36.5|53.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.1|36.5|<.0001
74056193|NCT05664672|147663798|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|41.8|||<|0.0001|TWO_SIDED|95.0|34.4|50.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||50.9|34.4|<.0001
74056194|NCT05664672|147663798|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|42.9|||<|0.0001|TWO_SIDED|95.0|34.9|52.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||52.7|34.9|<.0001
74056195|NCT05664672|147663798|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.9||||0.3027|TWO_SIDED|95.0|70.0|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|70.0|0.3027
74056196|NCT05664672|147663798|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|103.0||||0.9926|TWO_SIDED|95.0|83.9|125.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||125|83.9|0.9926
74056197|NCT05664672|147663798|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|97.5||||0.9938|TWO_SIDED|95.0|79.1|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|79.1|0.9938
74056198|NCT05664672|147663799|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|46.3|||<|0.0001|TWO_SIDED|95.0|39.5|54.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||54.4|39.5|<.0001
74056199|NCT05664672|147663799|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|55.6|||<|0.0001|TWO_SIDED|95.0|48.0|64.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||64.4|48.0|<.0001
74056200|NCT05664672|147663799|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|52.7|||<|0.0001|TWO_SIDED|95.0|45.2|61.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||61.5|45.2|<.0001
74056201|NCT05664672|147663799|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|54.9|||<|0.0001|TWO_SIDED|95.0|46.7|64.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||64.5|46.7|<.0001
74056202|NCT05664672|147663799|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|84.4||||0.0504|TWO_SIDED|95.0|71.2|100.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||100|71.2|0.0504
74056203|NCT05664672|147663799|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||0.9988|TWO_SIDED|95.0|86.4|119.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||119|86.4|0.9988
74056204|NCT05664672|147663799|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|96.0||||0.9238|TWO_SIDED|95.0|81.4|113.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||113|81.4|0.9238
74056205|NCT05664672|147663800|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|3.71|||<|0.0001|TWO_SIDED|95.0|1.88|7.31|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.31|1.88|<.0001
74056206|NCT05664672|147663800|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4.25|||<|0.0001|TWO_SIDED|95.0|2.28|7.93|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.93|2.28|<.0001
74056207|NCT05664672|147663800|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4.24|||<|0.0001|TWO_SIDED|95.0|2.2|8.14|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.14|2.20|<.0001
74056208|NCT05664672|147663800|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.4|||<|0.0001|TWO_SIDED|95.0|3.22|12.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||12.7|3.22|<.0001
74056209|NCT05664672|147663800|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|57.9||||0.184|TWO_SIDED|95.0|28.3|119.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||119|28.3|0.1840
74056210|NCT05664672|147663800|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|66.4||||0.3552|TWO_SIDED|95.0|34.0|130.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||130|34.0|0.3552
74056211|NCT05664672|147663800|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|66.2||||0.381|TWO_SIDED|95.0|33.0|133.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||133|33.0|0.3810
74056212|NCT05664672|147663801|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.8|||<|0.0001|TWO_SIDED|95.0|13.0|21.8|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||21.8|13.0|<.0001
74056213|NCT05664672|147663801|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|20.5|||<|0.0001|TWO_SIDED|95.0|16.2|25.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.9|16.2|<.0001
74056214|NCT05664672|147663801|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.2|||<|0.0001|TWO_SIDED|95.0|14.3|23.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||23.4|14.3|<.0001
74056215|NCT05664672|147663801|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|17.8|||<|0.0001|TWO_SIDED|95.0|13.7|23.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||23.1|13.7|<.0001
74056216|NCT05664672|147663801|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|94.5||||0.9589|TWO_SIDED|95.0|72.0|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|72.0|0.9589
74056217|NCT05664672|147663801|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|115.0||||0.4442|TWO_SIDED|95.0|89.3|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|89.3|0.4442
74056218|NCT05664672|147663801|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|103.0||||0.9975|TWO_SIDED|95.0|78.8|133.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||133|78.8|0.9975
73881675|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1857|TWO_SIDED|95.0|-0.61|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.12|-0.61|0.1857
74056219|NCT05664672|147663802|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|36.5|||<|0.0001|TWO_SIDED|95.0|23.9|55.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||55.6|23.9|<.0001
74056220|NCT05664672|147663802|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|39.9|||<|0.0001|TWO_SIDED|95.0|27.1|59.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||59.0|27.1|<.0001
74056221|NCT05664672|147663802|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|30.2|||<|0.0001|TWO_SIDED|95.0|20.1|45.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||45.5|20.1|<.0001
74056222|NCT05664672|147663802|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|48.9||||0.0002|TWO_SIDED|95.0|31.9|75.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||75.0|31.9|0.0002
74056223|NCT05664672|147663802|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|74.5||||0.2938|TWO_SIDED|95.0|47.6|117.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||117|47.6|0.2938
74056224|NCT05664672|147663802|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|81.6||||0.5552|TWO_SIDED|95.0|53.7|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|53.7|0.5552
74056225|NCT05664672|147663802|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|61.7||||0.0254|TWO_SIDED|95.0|39.9|95.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||95.5|39.9|0.0254
74056226|NCT05664672|147663803|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|52.1|||<|0.0001|TWO_SIDED|95.0|40.4|67.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||67.1|40.4|<.0001
74056227|NCT05664672|147663803|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|49.3|||<|0.0001|TWO_SIDED|95.0|39.0|62.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||62.2|39.0|<.0001
74056228|NCT05664672|147663803|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|40.8|||<|0.0001|TWO_SIDED|95.0|32.0|52.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||52.1|32.0|<.0001
74056229|NCT05664672|147663803|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|45.9|||<|0.0001|TWO_SIDED|95.0|35.7|59.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||59.2|35.7|<.0001
74056230|NCT05664672|147663803|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|113.0||||0.5817|TWO_SIDED|95.0|86.8|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|86.8|0.5817
74056231|NCT05664672|147663803|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|107.0||||0.8852|TWO_SIDED|95.0|83.7|138.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||138|83.7|0.8852
73881676|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.8631|TWO_SIDED|95.0|-0.33|0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.39|-0.33|0.8631
73881677|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0304|TWO_SIDED|95.0|-0.75|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||-0.04|-0.75|0.0304
74056232|NCT05664672|147663803|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.9||||0.607|TWO_SIDED|95.0|68.7|115.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||115|68.7|0.6070
74056233|NCT05664672|147663804|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.2|||<|0.0001|TWO_SIDED|95.0|5.44|32.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||32.0|5.44|<.0001
74056234|NCT05664672|147663804|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|23.8|||<|0.0001|TWO_SIDED|95.0|10.7|53.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.3|10.7|<.0001
74056235|NCT05664672|147663804|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.7||||0.0003|TWO_SIDED|95.0|10.6|57.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||57.4|10.6|0.0003
74056236|NCT05664672|147663804|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.3||||0.0002|TWO_SIDED|95.0|9.21|54.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||54.1|9.21|0.0002
74056237|NCT05664672|147663804|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|59.1||||0.428|TWO_SIDED|95.0|23.3|150.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||150|23.3|0.4280
74056238|NCT05664672|147663804|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|107.0||||0.999|TWO_SIDED|95.0|44.8|255.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||255|44.8|0.9990
74056239|NCT05664672|147663804|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|110.0||||0.9958|TWO_SIDED|95.0|44.9|272.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||272|44.9|0.9958
74056240|NCT05664672|147663805|SUPERIORITY||Ratio of geometric LS means|-50.8|||<|0.0001|TWO_SIDED|95.0|-77.7|-23.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-23.9|-77.7|<.0001
74056241|NCT05664672|147663805|SUPERIORITY||Ratio of geometric LS means|-45.0|||<|0.0001|TWO_SIDED|95.0|-69.6|-20.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-20.3|-69.6|<.0001
74056242|NCT05664672|147663805|SUPERIORITY||Ratio of geometric LS means|-42.3||||0.0003|TWO_SIDED|95.0|-68.2|-16.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-16.5|-68.2|0.0003
74056243|NCT05664672|147663805|SUPERIORITY||Ratio of geometric LS means|-44.8||||0.0004|TWO_SIDED|95.0|-72.6|-17.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-17.0|-72.6|0.0004
74056244|NCT05664672|147663805|SUPERIORITY||Ratio of geometric LS means|-6.05||||0.9551|TWO_SIDED|95.0|-35.2|23.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||23.1|-35.2|0.9551
74056245|NCT05664672|147663805|SUPERIORITY||Ratio of geometric LS means|-0.198||||1|TWO_SIDED|95.0|-27.3|26.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||26.9|-27.3|1.0000
74056246|NCT05664672|147663805|SUPERIORITY||Ratio of geometric LS means|2.48||||0.9981|TWO_SIDED|95.0|-25.6|30.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||30.6|-25.6|0.9981
74056247|NCT05664672|147663806|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|31.7|||<|0.0001|TWO_SIDED|95.0|18.7|53.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.9|18.7|<.0001
74056248|NCT05664672|147663806|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.5|||<|0.0001|TWO_SIDED|95.0|17.6|46.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||46.2|17.6|<.0001
74056249|NCT05664672|147663806|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.3|||<|0.0001|TWO_SIDED|95.0|14.7|40.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||40.2|14.7|<.0001
74100500|NCT02047734|147750451|SUPERIORITY||Rate Ratio|0.576|||<|0.0001|TWO_SIDED|95.0|0.465|0.714||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, age, and Baseline GdE lesions, and included the natural log transformation of available number of MRI scans as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.714|0.465|<0.0001
74100501|NCT02047734|147750451|SUPERIORITY||Rate Ratio|0.657||||0.0001|TWO_SIDED|95.0|0.531|0.813||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, age, and Baseline GdE lesions and included the natural log transformation of available number of MRI scans as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.813|0.531|0.0001
74100502|NCT02047734|147750452|SUPERIORITY||Rate Ratio|0.471||||0.0006|TWO_SIDED|95.0|0.306|0.725||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.|Rate ratio = Ozanimod / IFN β-1a|||0.725|0.306|0.0006
74100503|NCT02047734|147750452|SUPERIORITY||Rate Ratio|0.528||||0.003|TWO_SIDED|95.0|0.346|0.805||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative binomial regression model,|Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.|Rate ratio = Ozanimod / IFN β-1a|||0.805|0.346|0.0030
74056250|NCT05664672|147663806|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.1|||<|0.0001|TWO_SIDED|95.0|16.6|47.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||47.7|16.6|<.0001
74100504|NCT02047734|147750453|SUPERIORITY||Hazard Ratio (HR)|1.045||||0.8224|TWO_SIDED|95.0|0.711|1.537||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazards model|Adjusted for region (Eastern Europe vs Rest of World) age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.537|0.711|0.8224
74056251|NCT05664672|147663806|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|113.0||||0.9511|TWO_SIDED|95.0|64.7|197.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||197|64.7|0.9511
73881678|NCT03192176|147297635|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.63||0.1246|TWO_SIDED|95.0|-5.71|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.70|-5.71|0.1246
74056252|NCT05664672|147663806|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||1|TWO_SIDED|95.0|60.4|170.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||170|60.4|1.0000
74056253|NCT05664672|147663806|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.5||||0.9003|TWO_SIDED|95.0|50.6|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|50.6|0.9003
74056254|NCT05664672|147663807|SUPERIORITY||Ratio of geometric LS means|46.4|||<|0.0001|TWO_SIDED|95.0|37.1|58.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||58.0|37.1|<.0001
74056255|NCT05664672|147663807|SUPERIORITY||Ratio of geometric LS means|43.1|||<|0.0001|TWO_SIDED|95.0|35.1|52.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||52.9|35.1|<.0001
74056256|NCT05664672|147663807|SUPERIORITY||Ratio of geometric LS means|44.1|||<|0.0001|TWO_SIDED|95.0|35.5|54.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||54.6|35.5|<.0001
74056257|NCT05664672|147663807|SUPERIORITY||Ratio of geometric LS means|39.1|||<|0.0001|TWO_SIDED|95.0|31.0|49.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||49.4|31.0|<.0001
74056258|NCT05664672|147663807|SUPERIORITY||Ratio of geometric LS means|119.0||||0.2351|TWO_SIDED|95.0|93.2|151.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||151|93.2|0.2351
74056259|NCT05664672|147663807|SUPERIORITY||Ratio of geometric LS means|110.0||||0.657|TWO_SIDED|95.0|87.7|138.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||138|87.7|0.6570
74056260|NCT05664672|147663807|SUPERIORITY||Ratio of geometric LS means|113.0||||0.5112|TWO_SIDED|95.0|89.1|142.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||142|89.1|0.5112
74056261|NCT01598831|147663818|SUPERIORITY||Risk Difference (RD)|-2.55||||0.318|TWO_SIDED|95.0|-3.68|8.77||The threshold for statistical significance was a two sided 5%|Cochran-Mantel-Haenszel|CMH test controlled for the stratification factor.|Rates by Arm are 26.8% for ART-123 and 29.4% for Placebo||In a post hoc sensitivity analysis for the primary outcome that accounted for pooled site as a random effect, the adjusted 28-day all-cause mortality rate was 24.8%in the rhsTM group vs 27.5%in the placebo group (P = .31).|8.77|-3.68|0.318
74056262|NCT01018680|147663857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||Using a 1:1 ratio of allocation to treatment, a 2-tailed 0.05 level of significance and 80% power, 253 participants per arm had been estimated to be adequate to assess an effect size of 0.25, based on a 2-sample Student's t-test. This derived estimate was increased slightly to 261 participants per arm to account for extremely early discontinuation that would have led to exclusion from the efficacy analysis in a small number of participants (approximately 3%).||||<0.001
74056263|NCT01018680|147663858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001||95.0||||First gated secondary outcome measure. Gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 secondary outcomes with sequential comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
73888183|NCT01746901|147309541|SUPERIORITY_OR_OTHER||LS Mean Difference|19.5||||0.0008|TWO_SIDED|95.0|8.3|30.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.8|8.3|0.0008
73881679|NCT03192176|147297635|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.63||0.068|TWO_SIDED|95.0|-6.19|0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.22|-6.19|0.0680
73881680|NCT03192176|147297635|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.67||0.0729|TWO_SIDED|95.0|-6.28|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.28|-6.28|0.0729
73881681|NCT03192176|147297635|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|1.66||0.0541|TWO_SIDED|95.0|-6.49|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.06|-6.49|0.0541
74056264|NCT01018680|147663859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.84|||<|0.001||95.0||||WOMAC Physical Disability Score p-value. Second gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 2 secondary outcomes with sequential treatment comparisons until outcome failed significance (p\>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056265|NCT01018680|147663859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.001||95.0||||This is the p-value for the WOMAC Pain Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056266|NCT01018680|147663859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.004||95.0||||This is the p-value for WOMAC Stiffness Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.004
74056267|NCT01018680|147663860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.001||95.0||||This is the p-value for Night Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056268|NCT01018680|147663860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|||<|0.001||95.0||||This is the p-value for Worst Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056269|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||<|0.001||95.0||||This is the p-value for BPI-S for Worst Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056270|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001||95.0||||This is the p-value for BPI-S for Least Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056271|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-S for Average Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056272|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001||95.0||||This is the p-value for BPI-S for Pain Right Now. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
73888184|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|12.2|||<|0.0001|TWO_SIDED|95.0|7.1|17.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.4|7.1|<0.0001
74056273|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.001||95.0||||This is the p-value for BPI-I for General Activity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056274|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|||<|0.001||95.0||||This is the p-value for BPI-I for Mood. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056275|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-I for Walking Ability. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056276|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||<|0.001||95.0||||This is the p-value for BPI-I for Normal Work. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056277|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||<|0.001||95.0||||This is the p-value for BPI-I for Relations with Others. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056278|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001||95.0||||This is the p-value for BPI-I for Sleep. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74100505|NCT02047734|147750453|SUPERIORITY||Hazard Ratio (HR)|0.798||||0.2849|TWO_SIDED|95.0|0.528|1.206||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazards model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.206|0.528|0.2849
74100506|NCT02047734|147750454|SUPERIORITY||Hazard Ratio (HR)|1.435||||0.1353|TWO_SIDED|95.0|0.893|2.305||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazard model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||2.305|0.893|0.1353
74100507|NCT02047734|147750454|SUPERIORITY||Hazard Ratio (HR)|1.098||||0.7154|TWO_SIDED|95.0|0.664|1.815||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazard model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.815|0.664|0.7154
74100508|NCT02047734|147750455|SUPERIORITY||Difference|9.4||||0.0047|TWO_SIDED|95.0|2.9|15.8|||Cochran-Mantel-Haenszel|Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category||||15.8|2.9|0.0047
74100509|NCT02047734|147750455|SUPERIORITY||Difference|7.1||||0.032|TWO_SIDED|95.0|0.6|13.6|||Cochran-Mantel-Haenszel|Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category||||13.6|0.6|0.0320
74100510|NCT02047734|147750456|SUPERIORITY||Difference|5.4||||0.0466|TWO_SIDED|95.0|0.0|10.8|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category||||10.8|0.0|0.0466
73881682|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.64||0.696|TWO_SIDED|95.0|-3.87|2.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||2.59|-3.87|0.6960
74056279|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||<|0.001||95.0||||This is the p-value for BPI-I for Enjoyment of Life. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056280|NCT01018680|147663861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.001||95.0||||This is the p-value for BPI-I for Mean Interference Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056281|NCT01018680|147663862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74056282|NCT01018680|147663863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
74100511|NCT02047734|147750456|SUPERIORITY||Difference|5.1||||0.0581|TWO_SIDED|95.0|-0.3|10.5|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category||||10.5|-0.3|0.0581
74100512|NCT02047734|147750457|SUPERIORITY||Difference in means|0.244|||<|0.0001|TWO_SIDED|95.0|0.125|0.363||Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline|ANCOVA||Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|||0.363|0.125|<0.0001
74056283|NCT01018680|147663864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.449||95.0||||This is the p-value for the BPOMS Total Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.449
74056284|NCT01018680|147663864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.265||95.0||||This is the p-value for the BPOMS Tension-Anxiety Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.265
74056285|NCT01018680|147663864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.18||95.0||||This is the p-value for the BPOMS Depression-Dejection Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.180
74056286|NCT01018680|147663864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.041||95.0||||This is the p-value for the BPOMS Anger-Hostility Score. 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.041
74056287|NCT01018680|147663864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.356||95.0||||This is the p-value for the BPOMS Vigor-Activity Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.356
74056288|NCT01018680|147663864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.862||95.0||||This is the p-value for the BPOMS Fatigue-Inertia Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.862
74056289|NCT01018680|147663864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.883||95.0||||This is the p-value for the BPOMS Confusion-Bewilderment Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.883
74056290|NCT01018680|147663865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.083||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.083
74056291|NCT01018680|147663866|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
74056292|NCT01018680|147663867|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 30% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
74056293|NCT01018680|147663867|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 50% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
74056294|NCT01018680|147663868|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 30% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact|||||||<0.001
74056295|NCT01018680|147663868|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 50% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact|||||||<0.001
74056296|NCT01018680|147663869|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.012
74056297|NCT01018680|147663870|SUPERIORITY_OR_OTHER|||||||0.724||95.0||||This is the p-value for PCS Weight Gain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.724
74056298|NCT01018680|147663870|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||This is the p-value for PCS Weight Loss. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.106
74056299|NCT01018680|147663871|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.031
74056300|NCT01018680|147663872|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||This is the p-value for Diastolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.063
74056301|NCT01018680|147663872|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||This is the p-value for Systolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.018
74056302|NCT01018680|147663873|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.249
74056303|NCT01018680|147663874|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||This is the p-value for outpatient group visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.241
74056304|NCT01018680|147663874|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||This is the p-value for outpatient individual visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.087
74056305|NCT01018680|147663874|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||This is the p-value for emergency room visits for non-psychiatric illness. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.414
74056306|NCT01018680|147663874|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||This is the p-value for outpatient visits to other physicians. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.332
74056307|NCT01018680|147663874|SUPERIORITY_OR_OTHER|||||||0.183||95.0||||This is the p-value for the average number of hours worked for pay per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.183
74056308|NCT01018680|147663874|SUPERIORITY_OR_OTHER|||||||0.666||95.0||||This is the p-value for how long the participant has had this job. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.666
74100513|NCT02047734|147750457|SUPERIORITY||Difference in means|0.224||||0.0002|TWO_SIDED|95.0|0.106|0.342||Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|ANCOVA||Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|||0.342|0.106|0.0002
74100514|NCT02047734|147750458|SUPERIORITY||Difference in means|0.043||||0.248|TWO_SIDED|95.0|-0.03|0.116|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score|Difference in means are based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.|||0.116|-0.030|0.2480
74100515|NCT02047734|147750458|SUPERIORITY||Difference in means|0.093||||0.0123|TWO_SIDED|95.0|0.02|0.165|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.|||0.165|0.020|0.0123
74100516|NCT02047734|147750459|SUPERIORITY||Difference in means|1.345||||0.0988|TWO_SIDED|95.0|-0.252|2.943|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Physical Health Composite Summary Score||2.943|-0.252|0.0988
74100517|NCT02047734|147750459|SUPERIORITY||Difference in means|1.849||||0.0228|TWO_SIDED|95.0|0.258|3.44|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score.|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Physical Health Composite Summary Score||3.440|0.258|0.0228
74100518|NCT02047734|147750459|SUPERIORITY||Difference in means|0.38||||0.6997|TWO_SIDED|95.0|-1.553|2.313|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Mental Health Composite Summary Score||2.313|-1.553|0.6997
74100519|NCT02047734|147750459|SUPERIORITY||Difference in means|0.587||||0.5501|TWO_SIDED|95.0|-1.339|2.513|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and the Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Mental Health Composite Summary Score||2.513|-1.339|0.5501
74100520|NCT02047734|147750461|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline||||||<0.0001
74100521|NCT02047734|147750461|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline||||||<0.0001
74100522|NCT03713632|147750476|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0149|TWO_SIDED|95.0|1.05|2.55||one-sided p-value|Regression, Logistic|||||2.55|1.05|0.0149
74100523|NCT03713632|147750476|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0022|TWO_SIDED|95.0|1.22|2.96||one-sided p-value|Regression, Logistic|||||2.96|1.22|0.0022
74100524|NCT03713632|147750477|SUPERIORITY||Mean Difference (Net)|-16.33||||0.0051|TWO_SIDED|95.0|-28.79|-3.88||one-side p-value|ANCOVA|||||-3.88|-28.79|0.0051
74100525|NCT03713632|147750477|SUPERIORITY||Mean Difference (Net)|-22.94||||0.0001|TWO_SIDED|95.0|-35.24|-10.63||one-side p-value|ANCOVA|||||-10.63|-35.24|0.0001
74100526|NCT03713632|147750478|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0732|TWO_SIDED|95.0|0.41|1.14||one-sided p-value|Regression, Logistic|||||1.14|0.41|0.0732
74056309|NCT01018680|147663874|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||This is the p-value for the average number of hours of volunteer work per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.890
74056310|NCT01018680|147663874|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||This is the p-value for psychiatric visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.413
74056311|NCT04278846|147663937|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||||||.87
74056312|NCT04278846|147663938|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|||||||.49
74056313|NCT04278846|147663939|SUPERIORITY|||||||0.57|||||||Kruskal-Wallis|||||||.57
74056314|NCT04278846|147663940|SUPERIORITY|||||||0.3|||||||Kruskal-Wallis|||||||.3
74056315|NCT04278846|147663941|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||.99
74056316|NCT04278846|147663942|SUPERIORITY|||||||0.33|||||||Kruskal-Wallis|||||||.33
74056317|NCT04278846|147663943|SUPERIORITY|||||||0.26|||||||Kruskal-Wallis|||||||.26
74019688|NCT04426695|147591506|SUPERIORITY|||||||0.1981||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1981
74056318|NCT04278846|147663944|SUPERIORITY|||||||0.79|||||||Kruskal-Wallis|||||||.79
74056319|NCT04278846|147663945|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||||||.62
74056320|NCT04278846|147663946|SUPERIORITY|||||||0.94|||||||Kruskal-Wallis|||||||.94
74056321|NCT04278846|147663947|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||||||.95
74056322|NCT04278846|147663948|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||||||.54
74056323|NCT04278846|147663949|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||||||.95
74056324|NCT04278846|147663950|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||||||.96
74056325|NCT04278846|147663952|SUPERIORITY|||||||0.088|||||||Kruskal-Wallis|||||||.088
74056326|NCT04278846|147663953|SUPERIORITY|||||||0.42|||||||Kruskal-Wallis|||||||.42
74056327|NCT04278846|147663954|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||.88
74056328|NCT04278846|147663956|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||||||.12
74056329|NCT04278846|147663957|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
74056330|NCT04278846|147663958|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||.76
74056331|NCT04278846|147663959|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||.88
74056332|NCT04278846|147663960|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||.37
74056333|NCT01539512|147663964|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.1|0.32|||Log Rank|P-value is from stratified log-rank test, adjusted for randomization stratification factors.||||0.32|0.10|< 0.0001
74056334|NCT01539512|147663967|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.11|0.69||||||||0.69|0.11|
74056335|NCT01333501|147664008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.86|STANDARD_ERROR_OF_MEAN|2.7||0.494|TWO_SIDED|95.0|-3.51|7.23|||ANCOVA|||||7.23|-3.51|0.4940
74056336|NCT01333501|147664009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.97|STANDARD_ERROR_OF_MEAN|3.03||0.5183|TWO_SIDED|95.0|-4.06|7.99|||ANCOVA|||||7.99|-4.06|0.5183
74019689|NCT03653390|147591537|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 6 months.||||||<0.01
74019690|NCT03653390|147591537|SUPERIORITY||Mean Difference (Net)|-1.24||||0.11|TWO_SIDED|95.0|-2.71|0.22|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Wellness Education - EnhanceWellness for Disability|||0.22|-2.71|0.11
74056337|NCT01333501|147664010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|1.05||0.1334|TWO_SIDED|95.0|-3.69|0.5|||ANCOVA|||||0.50|-3.69|0.1334
74056338|NCT01333501|147664011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.73|STANDARD_ERROR_OF_MEAN|2.29||0.4501|TWO_SIDED|95.0|-6.27|2.81|||ANCOVA|||||2.81|-6.27|0.4501
74056339|NCT01333501|147664012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|2.53||0.8561|TWO_SIDED|95.0|-4.57|5.49|||ANCOVA|||||5.49|-4.57|0.8561
74056340|NCT01333501|147664013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|2.53||0.8858|TWO_SIDED|95.0|-4.67|5.4|||ANCOVA|||||5.40|-4.67|0.8858
74056341|NCT01333501|147664014|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.47||0.7119|TWO_SIDED|95.0|-0.76|1.11|||ANCOVA|||||1.11|-0.76|0.7119
74056342|NCT01333501|147664015|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.42||0.9496|TWO_SIDED|95.0|-0.86|0.81|||ANCOVA|||||0.81|-0.86|0.9496
74056343|NCT01333501|147664016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|1.18||0.8944|TWO_SIDED|95.0|-2.18|2.5|||ANCOVA|||||2.50|-2.18|0.8944
74056344|NCT01333501|147664017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.59||0.6757|TWO_SIDED|95.0|-1.42|0.92|||ANCOVA|||||0.92|-1.42|0.6757
74056345|NCT01333501|147664018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16|STANDARD_ERROR_OF_MEAN|2.34||0.3585|TWO_SIDED|95.0|-6.82|2.5|||ANCOVA|||||2.50|-6.82|0.3585
74056346|NCT01333501|147664019|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.24|STANDARD_ERROR_OF_MEAN|3.69||0.161|TWO_SIDED|95.0|-12.62|2.14|||ANCOVA|||||2.14|-12.62|0.1610
74056347|NCT00674440|147664029|OTHER||Sensitivity|93.0|||||TWO_SIDED|95.0|80.9|98.5||||||||98.5|80.9|
74056348|NCT00674440|147664029|OTHER||Specifity|88.5|||||TWO_SIDED|95.0|76.6|95.6||||||||95.6|76.6|
74056349|NCT00796367|147664043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.71|STANDARD_ERROR_OF_MEAN|0.673|<|0.0001|TWO_SIDED|95.0|7.39|10.03||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||10.03|7.39|<0.0001
74056350|NCT00796367|147664043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.52|STANDARD_ERROR_OF_MEAN|0.799|<|0.0001|TWO_SIDED|95.0|5.95|9.09||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||9.09|5.95|<0.0001
74056351|NCT00796367|147664043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19|STANDARD_ERROR_OF_MEAN|0.76||0.1189|TWO_SIDED|95.0|-0.31|2.68||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||2.68|-0.31|0.1189
74056352|NCT00796367|147664044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.4|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|6.24|14.16||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||14.16|6.24|<0.0001
74056353|NCT00796367|147664044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.99|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|4.36|11.19||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||11.19|4.36|<0.0001
74056354|NCT00796367|147664044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|STANDARD_ERROR_OF_MEAN|0.32||0.2169|TWO_SIDED|95.0|0.84|2.15|||Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||2.15|0.84|0.2169
74056355|NCT01728194|147664080|OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||< 0.025
74056356|NCT01728194|147664081|OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||<0.025
74019691|NCT03653390|147591537|SUPERIORITY||Mean Difference (Net)|-2.4|||<|0.01|TWO_SIDED|95.0|-3.85|-0.95|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Control - EnhanceWellness for Disability|||-0.95|-3.85|<0.01
74056357|NCT02309372|147664082|SUPERIORITY||Mean Difference (Net)|-0.76||||0.32|TWO_SIDED|95.0|-2.28|0.77|||t-test, 2 sided|||||0.77|-2.28|0.32
74056358|NCT01590810|147664114|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|1.15||0.503|TWO_SIDED|95.0|-1.59|3.15|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.15|-1.59|0.503
74056359|NCT01590810|147664114|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.86|-1.55|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.55|-2.86|<0.0001
74056360|NCT01590810|147664114|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.23|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|-10.13|-6.34|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.34|-10.13|<0.0001
74056361|NCT01590810|147664114|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.84|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-9.1|-4.58|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.58|-9.10|<0.0001
74056362|NCT01590810|147664114|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.41|STANDARD_ERROR_OF_MEAN|1.21|<|0.0001|TWO_SIDED|95.0|-12.89|-7.92|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.92|-12.89|<0.0001
74056363|NCT01590810|147664115|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|1.4||0.052|TWO_SIDED|95.0|-5.79|0.02|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.02|-5.79|0.052
74056364|NCT01590810|147664115|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.46|STANDARD_ERROR_OF_MEAN|1.95||0.01|TWO_SIDED|95.0|-9.49|-1.43|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.43|-9.49|0.010
74056365|NCT01590810|147664115|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.49|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-14.2|-4.79|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.79|-14.20|<0.001
74056366|NCT01590810|147664115|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.02|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-16.51|-7.52|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.52|-16.51|<0.0001
74056367|NCT01590810|147664115|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-12.93|-6.53|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.53|-12.93|<0.0001
74056368|NCT01590810|147664116|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|5.61||0.48|TWO_SIDED|95.0|-16.44|8.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.25|-16.44|0.480
74056369|NCT01590810|147664116|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.79|STANDARD_ERROR_OF_MEAN|5.72||0.086|TWO_SIDED|95.0|-23.37|1.79|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.79|-23.37|0.086
74100527|NCT03713632|147750478|SUPERIORITY||Odds Ratio (OR)|0.49||||0.0049|TWO_SIDED|95.0|0.29|0.84||one-sided p-value|Regression, Logistic|||||0.84|0.29|0.0049
74019692|NCT03653390|147591537|SUPERIORITY||Mean Difference (Net)|-1.16||||0.16|TWO_SIDED|95.0|-2.64|0.32|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Control - Wellness Education|||0.32|-2.64|0.16
74019693|NCT03653390|147591538|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 6 months.||||||<0.01
74056370|NCT01590810|147664116|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.51|STANDARD_ERROR_OF_MEAN|5.15||0.006|TWO_SIDED|95.0|-28.85|-6.18|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.18|-28.85|0.006
74056371|NCT01590810|147664117|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.21|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-16.84|-9.59|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.59|-16.84|<0.0001
74056372|NCT01590810|147664117|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|1.8|<|0.0001|TWO_SIDED|95.0|-13.94|-6.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.45|-13.94|<0.0001
74056373|NCT01590810|147664117|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.82|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-16.45|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.19|-16.45|<0.0001
74056374|NCT01590810|147664117|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.84|STANDARD_ERROR_OF_MEAN|1.75|<|0.0001|TWO_SIDED|95.0|-16.49|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.19|-16.49|<0.0001
74056375|NCT01590810|147664118|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|1.18||0.061|TWO_SIDED|95.0|-4.73|0.11|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.11|-4.73|0.061
74056376|NCT01590810|147664118|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.23|STANDARD_ERROR_OF_MEAN|0.86||0.016|TWO_SIDED|95.0|-4.0|-0.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.45|-4.00|0.016
74056377|NCT01590810|147664118|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.62|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-14.42|-8.82|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.82|-14.42|<0.0001
74056378|NCT01590810|147664118|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.15|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-11.34|-4.96|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.96|-11.34|<0.0001
74056379|NCT01590810|147664118|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.78|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-20.81|-12.75|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-12.75|-20.81|<0.0001
74056380|NCT01590810|147664119|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|1.26||0.029|TWO_SIDED|95.0|-5.56|-0.34|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.34|-5.56|0.029
74056381|NCT01590810|147664119|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.76|STANDARD_ERROR_OF_MEAN|2.19||0.005|TWO_SIDED|95.0|-11.29|-2.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.22|-11.29|0.005
74056382|NCT01590810|147664119|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.48|STANDARD_ERROR_OF_MEAN|3.16|<|0.001|TWO_SIDED|95.0|-20.03|-6.93|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.93|-20.03|<0.001
74056383|NCT01590810|147664119|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.33|STANDARD_ERROR_OF_MEAN|1.76|<|0.0001|TWO_SIDED|95.0|-21.98|-14.68|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-14.68|-21.98|<0.0001
74056384|NCT01590810|147664119|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.24|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-20.29|-12.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-12.19|-20.29|<0.0001
74056385|NCT01590810|147664120|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|2.51||0.539|TWO_SIDED|95.0|-7.12|3.93|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.93|-7.12|0.539
74056386|NCT01590810|147664120|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.36|STANDARD_ERROR_OF_MEAN|3.12||0.113|TWO_SIDED|95.0|-12.23|1.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.50|-12.23|0.113
74056387|NCT01590810|147664120|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-19.69|-8.91|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.91|-19.69|<0.001
74056388|NCT01590810|147664121|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.36|STANDARD_ERROR_OF_MEAN|1.56|<|0.0001|TWO_SIDED|95.0|-15.62|-9.11|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.11|-15.62|<0.0001
74056389|NCT01590810|147664121|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.58|STANDARD_ERROR_OF_MEAN|1.51|<|0.0001|TWO_SIDED|95.0|-13.74|-7.42|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.42|-13.74|<0.0001
74056390|NCT01590810|147664121|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.63|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-16.12|-11.13|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-11.13|-16.12|<0.0001
74056391|NCT01590810|147664121|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.96|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-15.85|-10.08|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-10.08|-15.85|<0.0001
74056392|NCT01590810|147664122|SUPERIORITY_OR_OTHER||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|0.75||0.175|TWO_SIDED|95.0|-0.5|2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.60|-0.50|0.175
74056393|NCT01590810|147664122|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|1.18||0.076|TWO_SIDED|95.0|-0.25|4.61|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.61|-0.25|0.076
74056394|NCT01590810|147664122|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|0.55||0.001|TWO_SIDED|95.0|1.04|3.32|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.32|1.04|0.001
74056395|NCT01590810|147664122|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|STANDARD_ERROR_OF_MEAN|1.22|<|0.0001|TWO_SIDED|95.0|3.14|8.15|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.15|3.14|<0.0001
74056396|NCT01590810|147664122|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|0.74||0.008|TWO_SIDED|95.0|0.63|3.67|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.67|0.63|0.008
74056397|NCT01590810|147664123|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.39||0.557|TWO_SIDED|95.0|-3.7|2.05|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.05|-3.70|0.557
74056398|NCT01590810|147664123|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|1.05||0.175|TWO_SIDED|95.0|-3.65|0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.70|-3.65|0.175
74056399|NCT01590810|147664123|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|1.52||0.951|TWO_SIDED|95.0|-3.04|3.23|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.23|-3.04|0.951
74056400|NCT01590810|147664123|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|1.34|3.88|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.88|1.34|<0.001
74056401|NCT01590810|147664123|SUPERIORITY_OR_OTHER||LS Mean Difference|4.62|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|3.0|6.24|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.24|3.00|<0.0001
74056402|NCT01590810|147664124|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|1.16||0.241|TWO_SIDED|95.0|-4.01|1.12|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.12|-4.01|0.241
74056403|NCT01590810|147664124|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|STANDARD_ERROR_OF_MEAN|2.07||0.664|TWO_SIDED|95.0|-3.63|5.48|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.48|-3.63|0.664
74056404|NCT01590810|147664124|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.13||0.114|TWO_SIDED|95.0|-1.03|8.33|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.33|-1.03|0.114
74056405|NCT01590810|147664125|SUPERIORITY_OR_OTHER||LS Mean Difference|4.42|STANDARD_ERROR_OF_MEAN|4.98||0.385|TWO_SIDED|95.0|-5.96|14.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||14.81|-5.96|0.385
74056406|NCT01590810|147664125|SUPERIORITY_OR_OTHER||LS Mean Difference|4.58|STANDARD_ERROR_OF_MEAN|5.15||0.385|TWO_SIDED|95.0|-6.16|15.32|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||15.32|-6.16|0.385
74056407|NCT01590810|147664125|SUPERIORITY_OR_OTHER||LS Mean Difference|5.15|STANDARD_ERROR_OF_MEAN|4.6||0.276|TWO_SIDED|95.0|-4.44|14.74|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||14.74|-4.44|0.276
74056408|NCT01590810|147664125|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5|STANDARD_ERROR_OF_MEAN|4.94||0.069|TWO_SIDED|95.0|-0.81|19.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||19.81|-0.81|0.069
74056409|NCT01590810|147664126|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|1.09||0.383|TWO_SIDED|95.0|-1.28|3.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.22|-1.28|0.383
74056410|NCT01590810|147664126|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.51||0.002|TWO_SIDED|95.0|-2.79|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.70|-2.79|0.002
74056411|NCT01590810|147664126|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.11|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-10.08|-6.14|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.14|-10.08|<0.0001
74056412|NCT01590810|147664126|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-9.74|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.25|-9.74|<0.001
74056413|NCT01590810|147664126|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED|95.0|-12.84|-7.78|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.78|-12.84|<0.0001
74056414|NCT01590810|147664127|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|1.62||0.216|TWO_SIDED|95.0|-5.43|1.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.30|-5.43|0.216
74056415|NCT01590810|147664127|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|2.27||0.046|TWO_SIDED|95.0|-9.51|-0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.10|-9.51|0.046
74100528|NCT03713632|147750479|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0026|TWO_SIDED|95.0|1.28|4.09||one-sided p-value|Regression, Logistic|||||4.09|1.28|0.0026
74100529|NCT03713632|147750479|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0206|TWO_SIDED|95.0|1.03|3.37||one-sided p-value|Regression, Logistic|||||3.37|1.03|0.0206
74019694|NCT03653390|147591538|SUPERIORITY||Mean Difference (Net)|-2.18||||0.018|TWO_SIDED|95.0|-4.05|-0.3||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||-0.30|-4.05|0.018
74019695|NCT03653390|147591538|SUPERIORITY||Mean Difference (Net)|-2.26||||0.012|TWO_SIDED|95.0|-4.12|-0.41||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||-0.41|-4.12|0.012
74019696|NCT03653390|147591538|SUPERIORITY||Mean Difference (Net)|-0.08||||0.99|TWO_SIDED|95.0|-1.98|1.81||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||1.81|-1.98|0.99
74019697|NCT03653390|147591539|SUPERIORITY|||||||0.382|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.382
74019698|NCT03653390|147591540|SUPERIORITY|||||||0.29|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.29
74019699|NCT03653390|147591541|SUPERIORITY|||||||0.057|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.057
74019700|NCT03653390|147591542|SUPERIORITY|||||||0.21|||||||ANOVA|The ANOVA was conducted on the change in number of trips from baseline to 12 months.||||||0.21
74019701|NCT03653390|147591543|SUPERIORITY|||||||0.79|||||||ANOVA|The ANOVA was conducted on the change in radius of gyration from baseline to 12 months.||||||0.79
74019702|NCT03653390|147591544|SUPERIORITY|||||||0.26|||||||ANOVA|The ANOVA was conducted on the change in number of trips from baseline to 12 months.||||||0.26
74019703|NCT03653390|147591545|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change in minutes from baseline to 12 months.||||||<0.01
74019704|NCT03653390|147591545|SUPERIORITY||Mean Difference (Net)|-28.7||||0.57|TWO_SIDED|95.0|-95.7|38.4||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||38.4|-95.7|0.57
74019705|NCT03653390|147591545|SUPERIORITY||Mean Difference (Net)|66.6||||0.048|TWO_SIDED|95.0|0.56|132.6||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||132.6|0.56|0.048
74019706|NCT03653390|147591545|SUPERIORITY||Mean Difference (Net)|95.3|||<|0.01|TWO_SIDED|95.0|31.8|158.7||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||158.7|31.8|<0.01
74019707|NCT03653390|147591546|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 12 months.||||||<0.01
74019708|NCT03653390|147591546|SUPERIORITY||Mean Difference (Net)|-1.55||||0.028|TWO_SIDED|95.0|-2.97|-0.13||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||-0.13|-2.97|0.028
74019709|NCT03653390|147591546|SUPERIORITY||Mean Difference (Net)|-2.15|||<|0.01|TWO_SIDED|95.0|-3.55|-0.75|||Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||-0.75|-3.55|<0.01
74019710|NCT03653390|147591546|SUPERIORITY||Mean Difference (Net)|-0.6||||0.59|TWO_SIDED|95.0|-2.03|0.83||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||0.83|-2.03|0.59
74019711|NCT01552681|147591572|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-value is testing for treatment effect using an analysis of covariance with adjustments for screening stimulated salivary flow.|ANCOVA|||Missing Week 24 assessments were imputed by carrying forward the last observed post-baseline value.||||0.33
74019712|NCT02769728|147591608|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||The threshold for statistical significance was p = 0.05||||0.001
74019713|NCT02769728|147591609|SUPERIORITY|||||||0.081||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.081
74019714|NCT02769728|147591610|SUPERIORITY|||||||0.114||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.114
74019715|NCT02769728|147591611|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.021
74019716|NCT02769728|147591612|SUPERIORITY|||||||1||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||1.00
74019717|NCT01262625|147591652|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|the pre-defined non-inferiority margin of 1.25|Hazard Ratio (HR)|1.03||||0.19|TWO_SIDED|95.0|0.61|1.75|||Regression, Cox|||||1.75|0.61|0.19
74019718|NCT01262625|147591653|SUPERIORITY|||||||0.08|||||||DeLong|(DeLong et al 1988)||||||0.08
74019719|NCT01262625|147591653|SUPERIORITY|||||||0.02|||||||DeLong|(DeLong et al 1988)||||||0.02
74019720|NCT00236080|147591658|NON_INFERIORITY_OR_EQUIVALENCE|Number of participants analyzed was determined by those participants who had at least 1 postbaseline efficacy assessment. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients. It is expected that the sample size will provide sufficient information for describing the specified evaluations.||||||0.1236||||||The p-value of Overall Treatment to Placebo|ANCOVA|This analysis adjusted for the difference among the treatment groups at baseline.||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint.||||0.1236
74019721|NCT00236080|147591659|NON_INFERIORITY_OR_EQUIVALENCE|Using the adjusted p value from Tukey's least significant difference (LSD) test for armodafinil at 200 mg/day. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients.||||||0.0945||||||The p-value of Overall Treatment to Placebo|ANCOVA|||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint .||||0.0945
73881683|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.63||0.9725|TWO_SIDED|95.0|-3.27|3.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||3.15|-3.27|0.9725
73881684|NCT03192176|147297635|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.63||0.0419|TWO_SIDED|95.0|-6.53|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||-0.12|-6.53|0.0419
74100530|NCT00295061|147750611|NON_INFERIORITY_OR_EQUIVALENCE|A total sample size of 20 subjects could demonstrate comparability of an AUC(0-7days) with 90% power up to a standard deviation of 0.288 of the difference in the log scale, expected mean treatment difference of 0 (= ratio of 1), a lower equivalence limit of -0.223 (= log 0.8), upper limit of 0.223 (= log 1.25) and a one-sided alpha of 0.05 (90% CI).|Geometric least square means ratio|1.03||||||90.0|0.97|1.09||||||To compare AUC 0-7 days between the two treatments (Alpha-1 MP vs. Prolastin),natural log-transformed AUC 0-7 days values were analyzed by analysis of variance (ANOVA).||1.09|0.97|
74100531|NCT00101283|147750612|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percent|18.8|||||TWO_SIDED|90.0|5.4|41.7|||||Overall response percent for Pemetrexed/Carboplatin arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.||41.7|5.4|
74100532|NCT00101283|147750612|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percent|0.0|||||TWO_SIDED|90.0|0.0|20.6|||||Overall response percent for Pemetrexed/Gemcitabine arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.||20.6|0.0|
74100533|NCT05084924|147750618|SUPERIORITY|||||||0.049|||||||ANOVA|Main effect of stimulation: F(2,32) = 3.32||||||0.049
74100534|NCT05084924|147750619|SUPERIORITY|||||||0.004||||||Main effect of stimulation: F(2,32) = 6.67|ANOVA|||||||0.004
74100535|NCT03774407|147750620|OTHER|||||||0.002||||||This P value reported was for bladder urinary frequency change from baseline to 9 months|p value|||||||0.002
74100536|NCT04841577|147750623|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for RSVPreF3 OA investigational vaccine is ≤ (equal to or smaller than) 1.5.|Adjusted group GMT ratio|1.27|||||TWO_SIDED|95.0|1.12|1.44||||||Adjusted ratios of Control group over Co-Ad Group in RSV-A Neutralizing antibody GMTs at one month after RSV\_PreF3 OA investigational vaccination. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed titers of RSV-A neutralizing antibodies The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 titer as covariate.||1.44|1.12|
74100537|NCT04841577|147750624|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean titer ratio|1.17|||||TWO_SIDED|95.0|1.02|1.35||||||For the Flu A/Hong Kong/2671/2019 (H3N2) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.35|1.02|
74100538|NCT04841577|147750624|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.22|||||TWO_SIDED|95.0|1.03|1.44||||||For the Flu A/Victoria/2570/2019 (H1N1) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.44|1.03|
74100539|NCT04841577|147750624|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.17|||||TWO_SIDED|95.0|1.04|1.32||||||For the Flu B/Phuket/3073/2013 (Yamagata) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.32|1.04|
74100540|NCT04841577|147750624|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.1|||||TWO_SIDED|95.0|0.95|1.26||||||For the Flu B/Washington/02/2019 (Victoria) strain, an ANOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.26|0.95|
74019722|NCT01214044|147591665|OTHER|A paired t-test was done to see if the time of the dim light melatonin onset changed from baseline to post-treatment.||||||0.2||||||A priori threshold for significance was p = 0.05.|t-test, 2 sided|paired t-test||A within subjects comparison was done to compare the time of the dim light melatonin onset before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11).||||0.2
73888185|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.6868|TWO_SIDED|95.0|-4.1|6.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.2|-4.1|0.6868
73881685|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.96||0.0794|TWO_SIDED|95.0|-3.57|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.20|-3.57|0.0794
74056416|NCT01590810|147664127|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.93|STANDARD_ERROR_OF_MEAN|2.5||0.002|TWO_SIDED|95.0|-14.1|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.76|-14.10|0.002
74056417|NCT01590810|147664127|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.16|STANDARD_ERROR_OF_MEAN|2.65|<|0.001|TWO_SIDED|95.0|-16.64|-5.68|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.68|-16.64|<0.001
74056418|NCT01590810|147664127|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.25|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-12.7|-5.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.80|-12.70|<0.0001
74056419|NCT01590810|147664128|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.27|STANDARD_ERROR_OF_MEAN|4.65||0.635|TWO_SIDED|95.0|-12.5|7.96|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.96|-12.50|0.635
74056420|NCT01590810|147664128|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.18|STANDARD_ERROR_OF_MEAN|5.18||0.143|TWO_SIDED|95.0|-19.58|3.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.22|-19.58|0.143
74056421|NCT01590810|147664128|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.51|STANDARD_ERROR_OF_MEAN|4.32||0.004|TWO_SIDED|95.0|-25.01|-6.01|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.01|-25.01|0.004
74056422|NCT01590810|147664129|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.84|STANDARD_ERROR_OF_MEAN|1.42|<|0.0001|TWO_SIDED|95.0|-13.79|-7.89|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.89|-13.79|<0.0001
74056423|NCT01590810|147664129|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.55|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|-11.18|-5.91|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.91|-11.18|<0.0001
74056424|NCT01590810|147664129|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.64|STANDARD_ERROR_OF_MEAN|1.34|<|0.0001|TWO_SIDED|95.0|-13.44|-7.84|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.84|-13.44|<0.0001
74056425|NCT01590810|147664129|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.13|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-13.97|-8.29|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.29|-13.97|<0.0001
74056426|NCT01590810|147664130|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|1.19||0.547|TWO_SIDED|95.0|-3.19|1.73|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.73|-3.19|0.547
74056427|NCT01590810|147664130|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.53||0.004|TWO_SIDED|95.0|-2.79|-0.62|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.62|-2.79|0.004
74056428|NCT01590810|147664130|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.59|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-6.23|-2.94|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.94|-6.23|<0.0001
74056429|NCT01590810|147664130|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.37|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.98|-1.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.76|-4.98|<0.001
74056430|NCT01590810|147664130|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.92|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-8.24|-3.59|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.59|-8.24|<0.0001
73881686|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.98||0.1153|TWO_SIDED|95.0|-3.47|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.38|-3.47|0.1153
74056431|NCT01590810|147664131|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.43|STANDARD_ERROR_OF_MEAN|1.33||0.017|TWO_SIDED|95.0|-6.19|-0.67|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.67|-6.19|0.017
74056432|NCT01590810|147664131|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.64|STANDARD_ERROR_OF_MEAN|1.35|<|0.001|TWO_SIDED|95.0|-8.43|-2.84|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.84|-8.43|<0.001
74056433|NCT01590810|147664131|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.99|STANDARD_ERROR_OF_MEAN|1.91||0.005|TWO_SIDED|95.0|-9.94|-2.04|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.04|-9.94|0.005
74056434|NCT01590810|147664131|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.73|<|0.001|TWO_SIDED|95.0|-10.9|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.76|-10.90|<0.001
74056435|NCT01590810|147664131|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.22|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|-7.76|-2.69|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.69|-7.76|<0.001
74056436|NCT01590810|147664132|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.93|STANDARD_ERROR_OF_MEAN|6.52||0.311|TWO_SIDED|95.0|-21.27|7.42|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.42|-21.27|0.311
74056437|NCT01590810|147664132|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.87|STANDARD_ERROR_OF_MEAN|6.62||0.078|TWO_SIDED|95.0|-27.44|1.69|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.69|-27.44|0.078
74056438|NCT01590810|147664132|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.03|STANDARD_ERROR_OF_MEAN|6.29||0.027|TWO_SIDED|95.0|-29.87|-2.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.19|-29.87|0.027
74056439|NCT01590810|147664133|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.77|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001|TWO_SIDED|95.0|-12.9|-6.65|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.65|-12.90|<0.0001
74056440|NCT01590810|147664133|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.19|STANDARD_ERROR_OF_MEAN|2.1||0.003|TWO_SIDED|95.0|-11.57|-2.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.81|-11.57|0.003
74056441|NCT01590810|147664133|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.19|STANDARD_ERROR_OF_MEAN|2.02||0.001|TWO_SIDED|95.0|-12.4|-3.98|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.98|-12.40|0.001
74056442|NCT01590810|147664133|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.47|STANDARD_ERROR_OF_MEAN|2.02||0.001|TWO_SIDED|95.0|-11.69|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.25|-11.69|0.001
74056443|NCT01590810|147664134|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|1.04||0.765|TWO_SIDED|95.0|-1.82|2.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.45|-1.82|0.765
74100541|NCT04841577|147750625|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|2.6|||||TWO_SIDED|95.0|-4.13|9.3|||Miettinen and Nurminen|||For the Flu A/Hong Kong/2671/2019 (H3N2) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||9.30|-4.13|
74100542|NCT04841577|147750625|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|4.53|||||TWO_SIDED|95.0|-0.77|9.83|||Miettinen and Nurminen|||For the Flu A/Victoria/2570/2019 (H1N1) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||9.83|-0.77|
74100543|NCT04841577|147750625|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|4.04|||||TWO_SIDED|95.0|-2.21|10.28|||Miettinen and Nurminen|||For the Flu B/Phuket/3073/2013 (Yamagata) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||10.28|-2.21|
74100544|NCT04841577|147750625|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|0.41|||||TWO_SIDED|95.0|-6.07|6.9|||Miettinen and Nurminen|||For the Flu B/Washington/02/2019 (Victoria) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||6.90|-6.07|
74100545|NCT04841577|147750627|OTHER||Adjusted group GMT ratio|1.28|||||TWO_SIDED|95.0|1.09|1.51||||||Adjusted ratios of Control group over Co-Ad Group in RSV-B Neutralizing antibody GMTs at one month after RSV\_PreF3 OA investigational vaccination. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed titers of RSV-B neutralizing antibodies. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 titer as covariate.||1.51|1.09|
74100546|NCT00182325|147750637|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74100547|NCT00182325|147750638|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
74100548|NCT00182325|147750639|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
74100549|NCT00182325|147750640|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
74056444|NCT01590810|147664134|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.56||0.023|TWO_SIDED|95.0|-2.49|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.20|-2.49|0.023
74100550|NCT00182325|147750641|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
74100551|NCT00182325|147750642|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
74100552|NCT00182325|147750643|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
74100553|NCT00182325|147750644|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
74100554|NCT00182325|147750645|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
74100555|NCT00182325|147750646|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
74056445|NCT01590810|147664134|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.77|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-9.18|-4.36|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.36|-9.18|<0.0001
74056446|NCT01590810|147664134|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.45|STANDARD_ERROR_OF_MEAN|1.95||0.01|TWO_SIDED|95.0|-9.46|-1.44|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.44|-9.46|0.010
74100556|NCT01890434|147750683|SUPERIORITY||Sensitivity Difference|16.7||||9e-05|ONE_SIDED|95.0|9.3||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||9.3|0.00009
74100557|NCT01890434|147750683|SUPERIORITY||Sensitivity Difference|26.0|||<|0.0001|ONE_SIDED|95.0|18.2||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||18.2|<0.0001
74100558|NCT01890434|147750683|SUPERIORITY||Sensitivity Difference|32.0|||<|0.0001|ONE_SIDED|95.0|24.5||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||24.5|<0.0001
74100559|NCT01890434|147750684|SUPERIORITY||Sensitivity Difference|21.0||||5e-05|ONE_SIDED|95.0|12.1||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||12.1|0.00005
74056447|NCT01590810|147664134|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.61|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|-11.28|-5.94|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.94|-11.28|<0.0001
74056448|NCT01590810|147664135|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.02|STANDARD_ERROR_OF_MEAN|1.39||0.16|TWO_SIDED|95.0|-4.89|0.86|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.86|-4.89|0.160
74056449|NCT01590810|147664135|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.32|STANDARD_ERROR_OF_MEAN|1.97||0.039|TWO_SIDED|95.0|-8.4|-0.24|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.24|-8.40|0.039
74056450|NCT01590810|147664135|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.75|STANDARD_ERROR_OF_MEAN|2.34||0.003|TWO_SIDED|95.0|-12.58|-2.92|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.92|-12.58|0.003
74056451|NCT01590810|147664135|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.79|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-14.49|-5.09|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.09|-14.49|<0.001
74056452|NCT01590810|147664135|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.31|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-11.3|-5.31|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.31|-11.30|<0.0001
74056453|NCT01590810|147664136|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|4.0||0.675|TWO_SIDED|95.0|-10.54|7.09|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.09|-10.54|0.675
74056454|NCT01590810|147664136|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.76|STANDARD_ERROR_OF_MEAN|4.64||0.174|TWO_SIDED|95.0|-16.98|3.46|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.46|-16.98|0.174
74056455|NCT01590810|147664136|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.68|STANDARD_ERROR_OF_MEAN|4.03||0.006|TWO_SIDED|95.0|-22.55|-4.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.81|-22.55|0.006
74056456|NCT01590810|147664137|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.12|STANDARD_ERROR_OF_MEAN|1.49|<|0.0001|TWO_SIDED|95.0|-12.22|-6.03|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.03|-12.22|<0.0001
74056457|NCT01590810|147664137|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.86|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-9.73|-3.99|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.99|-9.73|<0.0001
74056458|NCT01590810|147664137|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.57|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-11.51|-5.64|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.64|-11.51|<0.0001
74056459|NCT01590810|147664137|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.52|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-12.55|-6.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.50|-12.55|<0.0001
74056460|NCT04604015|147664138|OTHER||absolute difference|41.0|||<|0.001|TWO_SIDED|95.0|32.9|50.2|||McNemar|||The study was powered based on the results of a meta-analysis reporting the pooled NeuralBot (TCD) sensitivity for Right to Left Shunt detection, and the pooled TTE sensitivity for Right to Left Shunt detection.||50.2|32.9|<0.001
74100560|NCT01890434|147750684|SUPERIORITY||Sensitivity Difference|36.2|||<|0.0001|ONE_SIDED|95.0|26.3||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||26.3|<0.0001
74100561|NCT01890434|147750684|SUPERIORITY||Sensitivity Difference|41.0|||<|0.0001|ONE_SIDED|95.0|31.8||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||31.8|<0.0001
74100562|NCT01890434|147750689|SUPERIORITY||Sensitivity Difference|21.3|||<|0.0001|TWO_SIDED|95.0|12.9|28.4|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI.||28.4|12.9|<0.0001
74100563|NCT01890434|147750689|SUPERIORITY||Sensitivity Difference|21.3|||<|0.0001|TWO_SIDED|90.0|14.2|27.2|||McNemar|McNemar 2-sided test at alpha level of 10%||||27.2|14.2|<0.0001
74056461|NCT02129192|147664139|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|95.77|||||TWO_SIDED|90.0|88.89|103.17|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||103.17|88.89|
74056462|NCT02129192|147664139|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.4|||||TWO_SIDED|90.0|99.7|103.13|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||103.13|99.70|
74056463|NCT02129192|147664139|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.77|||||TWO_SIDED|90.0|98.46|105.19|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||105.19|98.46|
74056464|NCT02129192|147664140|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|30.15||||1|TWO_SIDED|90.0|24.99|36.38|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||36.38|24.99|1.0000
74100564|NCT01890434|147750691|NON_INFERIORITY|A non-inferiority margin was set as 15%|Sensitivity Difference|5.7||||0.2733|TWO_SIDED|95.0|-5.4|14.9|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by majority BR.||14.9|-5.4|0.2733
74100565|NCT01890434|147750691|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Sensitivity Difference|0.0||||1|TWO_SIDED|95.0|-8.6|7.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by investigator.||7.2|-8.6|1.0000
74056465|NCT02129192|147664140|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|98.23|||<|0.0001|TWO_SIDED|90.0|94.63|101.97|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||101.97|94.63|<0.0001
74056466|NCT02129192|147664140|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|79.69||||0.5422|TWO_SIDED|90.0|74.97|84.71|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||84.71|74.97|0.5422
74056467|NCT02129192|147664141|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|99.21|||||TWO_SIDED|90.0|96.14|102.38|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||102.38|96.14|
74056468|NCT02129192|147664141|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.43||||||90.0|99.84|103.04|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||103.04|99.84|
74056469|NCT02129192|147664141|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|100.33|||||TWO_SIDED|90.0|98.29|102.4|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||102.40|98.29|
74056470|NCT02129192|147664142|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|63.66||||1|TWO_SIDED|90.0|58.98|68.71|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||68.71|58.98|1.0000
74056471|NCT02129192|147664142|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|99.74|||<|0.0001|TWO_SIDED|90.0|97.08|102.48|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||102.48|97.08|<0.0001
74056472|NCT02129192|147664142|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|89.66||||0.0001|TWO_SIDED|90.0|85.8|93.7|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||93.70|85.80|0.0001
74056473|NCT02129192|147664143|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|99.62|||||TWO_SIDED|90.0|96.32|103.04|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||103.04|96.32|
74056474|NCT02129192|147664143|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|101.21|||||TWO_SIDED|90.0|99.59|102.87|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||102.87|99.59|
74056475|NCT02129192|147664143|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|100.15|||||TWO_SIDED|90.0|98.23|102.1|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||102.10|98.23|
74056476|NCT02129192|147664144|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|64.4||||1|TWO_SIDED|90.0|59.59|69.59|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||69.59|59.59|1.0000
74056477|NCT02129192|147664144|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|99.45|||<|0.0001|TWO_SIDED|90.0|96.69|102.29|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||102.29|96.69|<0.0001
74056478|NCT02129192|147664144|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|89.82|||<|0.0001|TWO_SIDED|90.0|86.02|93.79|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||93.79|86.02|<0.0001
74056479|NCT01231620|147664145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.73||||0.25|TWO_SIDED|95.0|-1.79|0.75|||Wilcoxon rank sum||IV Zanamivir 300 mg versus IV Zanamivir 600 mg|||0.75|-1.79|0.25
74056480|NCT01231620|147664145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.48||||0.39|TWO_SIDED|95.0|-2.11|0.97|||Wilcoxon rank sum||Oral oseltamivir 75 mg versus IV Zanamivir 600 mg|||0.97|-2.11|0.39
74056481|NCT01231620|147664146|SUPERIORITY_OR_OTHER|||||||0.506|||||||Wei-Johnson method|||||||0.506
74056482|NCT01231620|147664146|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wei-Johnson method|||||||0.41
74056483|NCT02486263|147664232|SUPERIORITY|||||||0.28||||||The threshold for statistical significance was \<0.05.|Chi-squared|||||||0.28
74100566|NCT01890434|147750693|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Specificity Difference|11.1||||0.001|TWO_SIDED|95.0|4.1|17.0|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by majority BR.||17.0|4.1|0.0010
74100567|NCT01890434|147750693|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Specificity Difference|7.8||||0.0094|TWO_SIDED|95.0|1.6|13.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by investigator.||13.2|1.6|0.0094
74100568|NCT02257385|147750713|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis:the difference between the trt means (umeclidinium/vilanterol minus indacaterol + tiotropium bromide) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium/vilanterol may be deemed statistically non-inferior to indacaterol plus tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, statistical superiority would have been established.|Least Squares Mean Difference|0.001||||0.964|TWO_SIDED|95.0|-0.029|0.03|||Mixed Models Analysis|||||0.030|-0.029|0.964
74100569|NCT02257385|147750714|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.023||||0.145|TWO_SIDED|95.0|-0.054|0.008|||Mixed Models Analysis|||||0.008|-0.054|0.145
74100570|NCT05199090|147750716|OTHER||adjusted means|-1.9||||0.0182|TWO_SIDED|80.0|-2.9|-0.9|||MMRM analysis|||Comparison of adjusted means||-0.9|-2.9|0.0182
74056484|NCT02486263|147664233|SUPERIORITY||Odds Ratio (OR)|0.8||||0.99|TWO_SIDED|95.0|0.4|1.6||Used Bonferroni adjustment for multiple comparisons. Threshold for statistical significance was p\<0.05|Generalized Estimation Equation||Data presented as OR (95% CI) using Generalized Estimation Equation (GEE) model with Conventional as reference.|Generalized Estimation Equation (GEE) model was used for the comparison of differences between intervention groups from week 0 to week 5 for peristaltic response frequency.||1.6|0.4|0.99
74056485|NCT02486263|147664234|SUPERIORITY|Weight velocity in grams/day||||||0.64|||||||t-test, 2 sided|||||||0.64
74056486|NCT02486263|147664235|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
74056487|NCT02486263|147664236|SUPERIORITY|||||||0.49||||||Threshold for statistical significance \<0.05|Chi-squared|||||||0.49
74056488|NCT03039699|147664258|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
74056489|NCT03039699|147664259|SUPERIORITY|||||||0.0675||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||48 hours timepoint comparison||||0.0675
74056490|NCT03039699|147664259|SUPERIORITY|||||||0.0675||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||72 hours timepoint comparison||||0.0675
74056491|NCT03039699|147664259|SUPERIORITY|||||||0.5569||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||96 hours timepoint comparison||||0.5569
74056492|NCT03039699|147664260|SUPERIORITY|||||||0.0696||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||48 hours timepoint comparison||||0.0696
74056493|NCT03039699|147664260|SUPERIORITY|||||||0.0696||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||72 hours timepoint comparison||||0.0696
74100571|NCT05199090|147750716|OTHER||adjusted means|-1.3||||0.1205|TWO_SIDED|80.0|-2.4|-0.2|||MMRM analysis|||||-0.2|-2.4|0.1205
74100572|NCT05199090|147750716|OTHER||adjusted means|-1.3||||0.0931|TWO_SIDED|80.0|-2.2|-0.3|||MMRM analysis|||||-0.3|-2.2|0.0931
74056494|NCT03039699|147664260|SUPERIORITY|||||||0.1998||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||96 hours timepoint comparison||||0.1998
74056495|NCT03039699|147664261|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||||||0.0039
74056496|NCT03039699|147664262|SUPERIORITY|||||||0.89||||||"The p-value associated with treatment\*visit interaction of total CDS score from 24 hours to 48 and 72 hours of treatment between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.89
74056497|NCT03039699|147664263|SUPERIORITY|||||||0.0044|||||||Wilcoxon (Mann-Whitney)|||||||0.0044
74056498|NCT03039699|147664264|SUPERIORITY|||||||0.5488||||||nonadjusted p-value|Fisher Exact|||Day 3 comparison||||0.5488
74056499|NCT03039699|147664264|SUPERIORITY|||||||0.814||||||nonadjusted p-value|Fisher Exact|||Day 4 comparison||||0.8140
74056500|NCT03039699|147664264|SUPERIORITY|||||||0.1248||||||nonadjusted p-value|Fisher Exact|||Day 6 comparison||||0.1248
74056501|NCT03039699|147664264|SUPERIORITY|||||||0.3889||||||nonadjusted p-value|Fisher Exact|||Day 10 comparison||||0.3889
74056502|NCT03039699|147664265|SUPERIORITY|||||||0.3593|||||||Fisher Exact|||||||0.3593
74056503|NCT00129220|147664266|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.62|||<|0.001|TWO_SIDED|95.0|-8.87|-2.37|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-2.37|-8.87|<0.001
74056504|NCT00129220|147664267|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78||||0.774|TWO_SIDED|95.0|-6.15|4.59|||ANCOVA||Least Squares Mean Difference = Olazapine minus Haloperidol.|||4.59|-6.15|0.774
74056505|NCT00129220|147664268|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|21.0||||0.064|TWO_SIDED|95.0|1.6|40.4|||Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||40.4|1.6|0.064
74056506|NCT00129220|147664269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47||||0.171|TWO_SIDED|95.0|-1.15|0.21|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||0.21|-1.15|0.171
74100573|NCT05199090|147750716|OTHER||adjusted means|0.6||||0.4994|TWO_SIDED|80.0|-0.5|1.7|||MMRM analysis|||||1.7|-0.5|0.4994
74100574|NCT05199090|147750716|OTHER||adjusted means|1.0||||0.2295|TWO_SIDED|80.0|-0.1|2.1|||MMRM analysis|||||2.1|-0.1|0.2295
74100575|NCT05199090|147750716|OTHER||adjusted means|-0.7||||0.2114|TWO_SIDED|80.0|-1.3|0.0|||MMRM analysis|||||0.0|-1.3|0.2114
74100576|NCT02686138|147750766|SUPERIORITY||Risk Difference (RD)|12.85|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74100577|NCT02686138|147750767|SUPERIORITY||Risk Difference (RD)|14.11|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74019723|NCT01214044|147591666|OTHER|A paired t-test was done to see if the Hamilton-21 score decreased from baseline to post-treatment.||||||0.01||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Hamilton-21 score with escitalopram treatment.~A within subjects comparison was done to compare the Hamilton-21 score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."||||0.01
74019724|NCT01214044|147591667|OTHER|A paired t-test was done to see if the Beck Depression Inventory-II score decreased from baseline to post-treatment.||||||0.14||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Beck Depression Inventory-II score with escitalopram treatment.~A within subjects comparison was done to compare the Beck Depression Inventory-II score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."||||0.14
74019725|NCT01214044|147591668|OTHER|Spearman's rank-order correlation (non-parametric test) was used.||||||0.06||||||Spearman's rho (rs) = 0.66|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Hamilton-21 score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.||||0.06
74019726|NCT01214044|147591668|OTHER|Spearman's rank-order correlation (non-parametric test) was used.||||||0.48||||||Spearman's rho (rs) = 0.02|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Beck Depression Inventory-II score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.||||0.48
74019727|NCT04698525|147591678|NON_INFERIORITY|"A new treatment (memantine) that is not much worse or non-inferior to the standard treatment (valproate) may be attractive if, compared to it, it is expected to cause fewer side effects or improve quality of life or if its dosing regimen is easier to tolerate."|Mean Difference (Final Values)|5.3|STANDARD_DEVIATION|14.0||0.9|TWO_SIDED|95.0|0.0|10.0||"Comparison between VPA and Memantine was:~0.9 p-value (two-tailed)"|Wilcoxon (Mann-Whitney)|"Memantine 3.534 z corrected for ties 0.0004 p-value (two-tailed)~VPA 3.418 z corrected for ties 0.0006 p-value (two-tailed)"||Null hypothesis: Memantine is as effective as valproate in treating episodic migraine.|We made also student t|10|0|0.9
74019728|NCT05384041|147591683|SUPERIORITY|||||||0.056|||||||Regression, Linear|||Intent to Treat analyses||||0.056
74019729|NCT05384041|147591684|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||Difference (Active - Control) at Week 1||||0.048
74019730|NCT05384041|147591685|SUPERIORITY|||||||0.2595|||||||t-test, 2 sided|||Difference (Active-Control) at Week 1||||0.2595
74019731|NCT05384041|147591685|SUPERIORITY|||||||0.1286|||||||t-test, 2 sided|||Difference (Active-Control) at Week 2||||0.1286
74019732|NCT05384041|147591685|SUPERIORITY|||||||0.1449|||||||t-test, 2 sided|||Difference (Active-Control) at Week 4||||0.1449
74019733|NCT05384041|147591686|SUPERIORITY|||||||0.2065|||||||t-test, 2 sided|||Difference (Active-Control) at Week 1||||0.2065
74019734|NCT05384041|147591686|SUPERIORITY|||||||0.1349|||||||t-test, 2 sided|||Difference (Active-Control) at Week 2||||0.1349
74019735|NCT05384041|147591686|SUPERIORITY|||||||0.1142|||||||t-test, 2 sided|||Difference (Active-Control) at Week 4||||0.1142
74019736|NCT05384041|147591687|SUPERIORITY|||||||0.231|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.231
74019737|NCT05384041|147591687|SUPERIORITY|||||||0.192|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.192
74019738|NCT05384041|147591687|SUPERIORITY|||||||0.045|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.045
74019739|NCT05384041|147591689|SUPERIORITY|||||||0.005|||||||Regression, Linear|||||||0.005
74019740|NCT05384041|147591690|SUPERIORITY|||||||0.0026|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.0026
74019741|NCT05384041|147591690|SUPERIORITY|||||||0.4706|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.4706
74019742|NCT05384041|147591690|SUPERIORITY|||||||0.0197|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.0197
74019743|NCT05384041|147591690|SUPERIORITY|||||||0.4858|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.4858
74019744|NCT05384041|147591690|SUPERIORITY|||||||0.0183|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.0183
74019745|NCT05384041|147591690|SUPERIORITY|||||||0.7885|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.7885
74019746|NCT05384041|147591691|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||<0.001
74019747|NCT05384041|147591691|SUPERIORITY|||||||0.45|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.450
74019748|NCT05384041|147591691|SUPERIORITY|||||||0.008|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.008
74019749|NCT05384041|147591691|SUPERIORITY|||||||0.438|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.438
74019750|NCT05384041|147591691|SUPERIORITY|||||||0.016|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.016
74019751|NCT05384041|147591691|SUPERIORITY|||||||0.355|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.355
74019752|NCT05384041|147591692|SUPERIORITY|||||||0.046|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.046
74019753|NCT05384041|147591692|SUPERIORITY|||||||0.351|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.351
74019754|NCT05384041|147591692|SUPERIORITY|||||||0.053|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.053
74019755|NCT05384041|147591692|SUPERIORITY|||||||0.12|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.120
74019756|NCT05384041|147591692|SUPERIORITY|||||||0.17|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.170
74019757|NCT05384041|147591692|SUPERIORITY|||||||0.122|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.122
74019758|NCT05384041|147591693|SUPERIORITY|||||||0.044|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.044
74019759|NCT05384041|147591693|SUPERIORITY|||||||0.751|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.751
74019760|NCT05384041|147591693|SUPERIORITY|||||||0.013|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.013
74019761|NCT05384041|147591693|SUPERIORITY|||||||0.318|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.318
74100578|NCT02686138|147750768|SUPERIORITY||Risk Difference (RD)|11.5||||0.004|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.004
74056507|NCT00129220|147664270|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.51||||0.006|TWO_SIDED|95.0|-0.87|-0.15||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-0.15|-0.87|0.006
74056508|NCT00129220|147664270|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.13||||0.722|TWO_SIDED|95.0|-0.82|0.57||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||0.57|-0.82|0.722
74056509|NCT00129220|147664271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7||||0.333|TWO_SIDED|95.0|-6.7|20.1||P-value for 3-Week Response Rate.|Cochran-Mantel-Haenszel|||||20.1|-6.7|0.333
74056510|NCT00129220|147664271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.908|TWO_SIDED|95.0|-21.0|18.4||P-value for 6-Week Response Rate.|Cochran-Mantel-Haenszel|||||18.4|-21.0|0.908
74056511|NCT00129220|147664272|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.9||||0.384|TWO_SIDED|95.0|-7.3|19.2||P-value for 3-Week Remission Rate.|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Placebo.|||19.2|-7.3|0.384
74056512|NCT00129220|147664272|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3||||0.982|TWO_SIDED|95.0|-21.3|21.8||P-value is for 6-Week Remission Rate|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||21.8|-21.3|0.982
74056513|NCT00129220|147664273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.698|TWO_SIDED|95.0|-3.2|4.9||P-value for 3-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel|||||4.9|-3.2|0.698
74056514|NCT00129220|147664273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.1||||0.014|TWO_SIDED|95.0|-31.7|3.4||P-value for 6-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel|||||3.4|-31.7|0.014
74056515|NCT00129220|147664274|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.48||||0.019|TWO_SIDED|95.0|-2.71|-0.25||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-0.25|-2.71|0.019
74056516|NCT00129220|147664274|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16||||0.855|TWO_SIDED|95.0|-1.95|1.62||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||1.62|-1.95|0.855
74056517|NCT00129220|147664275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.136|TWO_SIDED|95.0|-14.9|5.7||P-value for 6-Week Syndromic Depression Rate.|Cochran-Mantel-Haenszel|||||5.7|-14.9|0.136
74056518|NCT00129220|147664276|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Maximum Change from Baseline.|Wilcoxon Rank Sum|||||||0.003
74056519|NCT01883362|147664277|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.2655|TWO_SIDED|95.0|0.12|1.86|||Log Rank|||||1.86|0.12|0.2655
74056520|NCT01883362|147664278|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.4297|TWO_SIDED|95.0|0.17|2.14|||Log Rank|||||2.14|0.17|0.4297
74056521|NCT01883362|147664279|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.2424|TWO_SIDED|95.0|0.2|1.52|||Log Rank|||||1.52|0.20|0.2424
74056522|NCT01883362|147664280|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.4297|TWO_SIDED|95.0|0.17|2.14|||Log Rank|||||2.14|0.17|0.4297
74056523|NCT01883362|147664281|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.3418|TWO_SIDED|95.0|0.19|1.79|||Log Rank|||||1.79|0.19|0.3418
74056524|NCT01883362|147664282|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.4169|TWO_SIDED|95.0|0.09|2.74|||Log Rank|||||2.74|0.09|0.4169
74056525|NCT02985541|147664326|OTHER||3-year probability of getting pregnant|0.68|||||TWO_SIDED|95.0|0.17|2.71||||||Cumulative failure rate (Kaplan-Meier) during Years 6-8||2.71|0.17|
74056526|NCT01458535|147664349|SUPERIORITY_OR_OTHER|||||||0.157|||||||Cochran-Mantel-Haenszel|||||||0.157
74056527|NCT01458535|147664349|SUPERIORITY_OR_OTHER|||||||0.999|||||||Cochran-Mantel-Haenszel|||||||0.999
74056528|NCT01458535|147664349|SUPERIORITY_OR_OTHER|||||||0.045|||||||Cochran-Mantel-Haenszel|||||||0.045
74056529|NCT01238861|147664356|SUPERIORITY_OR_OTHER||Rate Ratio|1.09||||0.781|TWO_SIDED|80.0|0.74|1.59|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||1.59|0.74|0.781
74056530|NCT01238861|147664356|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.173|TWO_SIDED|80.0|0.42|0.97|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||0.97|0.42|0.173
74056531|NCT01238861|147664356|SUPERIORITY_OR_OTHER||Rate ratio|0.59||||0.096|TWO_SIDED|80.0|0.4|0.89|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||0.89|0.40|0.096
74056532|NCT01238861|147664361|SUPERIORITY_OR_OTHER|||||||0.125|||||||ANCOVA|P-value was calculated by analysis of covariance (ANCOVA) with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.125
74056533|NCT01238861|147664361|SUPERIORITY_OR_OTHER|||||||0.074|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.074
74056534|NCT01238861|147664361|SUPERIORITY_OR_OTHER|||||||0.057|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.057
74056535|NCT01238861|147664361|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.010
74056536|NCT01238861|147664363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.131|TWO_SIDED|80.0|-0.336|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.028|-0.336|0.131
74056537|NCT01238861|147664363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.173||||0.126|TWO_SIDED|80.0|-0.317|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.028|-0.317|0.126
74056538|NCT01238861|147664363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.097|TWO_SIDED|80.0|-0.247|-0.032|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.032|-0.247|0.097
74056539|NCT01238861|147664364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.642|TWO_SIDED|80.0|-0.654|0.306|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.306|-0.654|0.642
74100579|NCT02686138|147750769|SUPERIORITY||Risk Difference (RD)|11.16||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.003
73888186|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.0058|TWO_SIDED|95.0|2.2|12.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.5|2.2|0.0058
74056540|NCT01238861|147664364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111||||0.824|TWO_SIDED|80.0|-0.533|0.756|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.756|-0.533|0.824
74056541|NCT01238861|147664364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.91|TWO_SIDED|80.0|-0.297|0.355|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.355|-0.297|0.910
74056542|NCT01238861|147664364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004||||0.992|TWO_SIDED|80.0|-0.602|0.593|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||0.593|-0.602|0.992
74056543|NCT01238861|147664364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337||||0.624|TWO_SIDED|80.0|-0.548|1.222|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||1.222|-0.548|0.624
74056544|NCT01238861|147664364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.645|TWO_SIDED|80.0|-0.267|0.567|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||0.567|-0.267|0.645
74056545|NCT01238861|147664365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157||||0.014|TWO_SIDED|80.0|0.076|0.237|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.237|0.076|0.014
74056546|NCT01238861|147664365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184||||0.004|TWO_SIDED|80.0|0.102|0.266|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.266|0.102|0.004
74056547|NCT01238861|147664365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091||||0.026|TWO_SIDED|80.0|0.039|0.143|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.143|0.039|0.026
74056548|NCT01238861|147664366|SUPERIORITY_OR_OTHER|||||||0.384|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.384
74056549|NCT01238861|147664366|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.092
74056550|NCT01238861|147664366|SUPERIORITY_OR_OTHER|||||||0.134|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.134
74056551|NCT01238861|147664366|SUPERIORITY_OR_OTHER|||||||0.129|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.129
74056552|NCT01238861|147664368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.404||||0.069|TWO_SIDED|80.0|0.121|0.687|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.687|0.121|0.069
74056553|NCT01238861|147664368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462||||0.049|TWO_SIDED|80.0|0.163|0.761|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.761|0.163|0.049
74056554|NCT01238861|147664368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.168|TWO_SIDED|80.0|0.017|0.459|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.459|0.017|0.168
74056555|NCT01238861|147664369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.51|TWO_SIDED|80.0|-0.058|0.019|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.019|-0.058|0.510
74056556|NCT01238861|147664369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041||||0.113|TWO_SIDED|80.0|0.008|0.074|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.074|0.008|0.113
74056557|NCT01238861|147664369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.599|TWO_SIDED|80.0|-0.016|0.038|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.038|-0.016|0.599
74056558|NCT01238861|147664370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373||||0.871|TWO_SIDED|80.0|-3.333|2.586|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||2.586|-3.333|0.871
74056559|NCT01238861|147664370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.857||||0.227|TWO_SIDED|80.0|-0.175|5.889|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||5.889|-0.175|0.227
74056560|NCT01238861|147664370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.139||||0.503|TWO_SIDED|80.0|-1.041|3.319|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||3.319|-1.041|0.503
74056561|NCT01238861|147664371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.907||||0.55|TWO_SIDED|80.0|-4.483|12.297|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||12.297|-4.483|0.550
74056562|NCT01238861|147664371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.659||||0.215|TWO_SIDED|80.0|-0.262|15.579|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||15.579|-0.262|0.215
74056563|NCT01238861|147664371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54||||0.413|TWO_SIDED|80.0|-2.006|9.086|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||9.086|-2.006|0.413
74056564|NCT01238861|147664372|SUPERIORITY_OR_OTHER|||||||0.896|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.896
74100580|NCT02686138|147750770|SUPERIORITY||Risk Difference (RD)|10.3||||0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.01
74056565|NCT01238861|147664372|SUPERIORITY_OR_OTHER|||||||0.944|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.944
74056566|NCT01238861|147664372|SUPERIORITY_OR_OTHER|||||||0.667|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.667
74056567|NCT04602078|147664403|SUPERIORITY|||||||0.444|||||||Log Rank|||Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative||||0.444
74056568|NCT04602078|147664404|SUPERIORITY|||||||0.414|||||||Chi-squared|||Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative||||0.414
74056569|NCT01982942|147664437|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||The null hypothesis states that the BPF rates of change in the treatment and placebo groups are equal, which can be evaluated based on as assessment of parameter estimates from a linear mixed model (LMM).||||0.04
74056570|NCT06104423|147664461|SUPERIORITY||Mean difference pre vs post treatment|-19.2|STANDARD_DEVIATION|8.62|<|0.001|TWO_SIDED|95.0|-26.0|-14.0|||paired t-test|||Primary endpoint, verified on the single cohort of patients who completed the monotherapy run-in period, is calculated as the mean difference in sitting systolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 5 (Week 12, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)||-14.0|-26.0|< 0.001
74056571|NCT00750061|147664462|SUPERIORITY_OR_OTHER|||||||0.343|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change light touch score (wk6-d0)||||0.343
74056572|NCT00750061|147664462|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change light touch score (m6-d0)||||0.69
74056573|NCT00750061|147664462|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (wk6-d0)||||1
74056574|NCT00750061|147664462|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (m6-d0)||||0.32
74056575|NCT00750061|147664462|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change motor score (wk6-d0)||||1
74056576|NCT00750061|147664462|SUPERIORITY_OR_OTHER|||||||0.582|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change motor score (m6-d0)||||0.582
74056577|NCT00750061|147664463|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||FIM change (Wk6 - D0)||||0.257
74056578|NCT00750061|147664463|SUPERIORITY_OR_OTHER|||||||0.168|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||FIM change (M6 - D0)||||0.168
74056579|NCT00750061|147664463|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS change (Wk6 - D0)||||0.013
74056580|NCT00750061|147664463|SUPERIORITY_OR_OTHER|||||||0.137|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS change (M6 - D0)||||0.137
74056581|NCT00727246|147664464|OTHER|||||||0.85|TWO_SIDED|95.0|||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. A mean index score created as a composite cognitive performance across domains (higher t-score = higher cognition). Purpose was to serve as a measure of overall cognitive functioning for data analysis.||||.85
74056582|NCT00727246|147664465|OTHER|||||||0.329|TWO_SIDED|0.95|||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measure ANOVA was completed to evaluate potential differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo.||||.329
74056583|NCT03417245|147664524|SUPERIORITY||ABR ratio|0.101|||<|0.0001|TWO_SIDED|95.0|0.064|0.159||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression mode|||||0.159|0.064|<0.0001
74056584|NCT03417245|147664526|SUPERIORITY||ABR ratio|0.13|||<|0.0001|TWO_SIDED|95.0|0.09|0.188||P-value derived from NB regression model during TP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.188|0.090|<0.0001
74056585|NCT03417245|147664528|SUPERIORITY||ABR ratio|0.083|||<|0.0001|TWO_SIDED|95.0|0.049|0.141||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.141|0.049|<0.0001
74056586|NCT03417245|147664530|SUPERIORITY||ABR ratio|0.097|||<|0.0001|TWO_SIDED|95.0|0.059|0.161||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.161|0.059|<0.0001
74056587|NCT03417245|147664532|SUPERIORITY||Least Square (LS) Mean difference|-19.75|||<|0.0001|TWO_SIDED|95.0|-27.0|-12.5||Analysis of Covariance (ANCOVA) model included treatment arm, number of bleeds in 6 months prior to study (\<=10,\>10) and hemophilia type (A vs B) as fixed effects, Baseline score as covariate. Significance threshold was at 0.05.|ANCOVA|||||-12.50|-27.00|<0.0001
74056588|NCT03417245|147664533|SUPERIORITY||LS Mean difference|-7.07|||=|0.0011|TWO_SIDED|95.0|-11.23|-2.9||ANCOVA model included treatment arm, number of bleeds in 6 months prior to study (\<=10,\>10) and hemophilia type (A vs B) as fixed effects, Baseline score as covariate. Significance threshold was at 0.05.|ANCOVA|||||-2.90|-11.23|=0.0011
74056589|NCT02067728|147664688|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||Chi-squared|||||||0.0029
74056590|NCT02067728|147664689|SUPERIORITY_OR_OTHER|||||||0.3875|TWO_SIDED||||||t-test, 2 sided|||||||0.3875
74056591|NCT02067728|147664690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_DEVIATION|0.42|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
74056592|NCT02067728|147664691|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
74056593|NCT02067728|147664692|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||||||1.000
74056594|NCT02067728|147664693|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.3|||<|0.0001|TWO_SIDED|95.0|2.2|4.9|||Chi-squared|||||4.9|2.2|<0.0001
73881687|NCT03192176|147297635|SUPERIORITY||-1.5|-1.5|STANDARD_ERROR_OF_MEAN|1.0||0.1334|TWO_SIDED|95.0|-3.47|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.46|-3.47|0.1334
73881688|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.0||0.3457|TWO_SIDED|95.0|-2.93|1.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||1.03|-2.93|0.3457
73881689|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.99||0.2607|TWO_SIDED|95.0|-3.07|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.83|-3.07|0.2607
74056595|NCT02067728|147664694|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.9|||<|0.0001|TWO_SIDED|95.0|2.0|4.5|||Chi-squared|||||4.5|2.0|<0.0001
74056596|NCT02067728|147664697|SUPERIORITY_OR_OTHER|||||||0.4835|TWO_SIDED||||||t-test, 2 sided|||||||0.4835
74056597|NCT02067728|147664698|SUPERIORITY_OR_OTHER|||||||0.588|TWO_SIDED||||||t-test, 2 sided|||||||0.5880
74056598|NCT03602976|147664709|SUPERIORITY||Mean Difference (Final Values)|190.7||||0.059|TWO_SIDED||||||t-test, 2 sided|||For GGT||||0.059
74100581|NCT02686138|147750771|SUPERIORITY||Risk Difference (RD)|10.17||||0.013|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.013
74100582|NCT02686138|147750772|SUPERIORITY||Risk Difference (RD)|13.1|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74056599|NCT03602976|147664709|SUPERIORITY||Mean Difference (Final Values)|55.5||||0.23|TWO_SIDED||||||t-test, 2 sided|||For Alkaline Phosphatase||||0.23
74056600|NCT03602976|147664710|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
74056601|NCT03602976|147664711|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.73|TWO_SIDED||||||t-test, 2 sided|||||||0.73
74056602|NCT03602976|147664712|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.094|TWO_SIDED||||||t-test, 2 sided|||||||0.094
74056603|NCT03602976|147664713|SUPERIORITY||Mean Difference (Final Values)|21.0||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
74056604|NCT04837807|147664714|SUPERIORITY||Mean Difference (Final Values)|22.4|STANDARD_DEVIATION|12.8|<|0.05|TWO_SIDED||||||ANOVA|This was a cross-over study, so there is really 30 subjects per group that was analyzed.||"Each participant in the study was asked to complete the IDEEL work at their baseline, week 1 and week 2 visits. The IDEEL work is graded on a scale to 100 with higher numbers being deemed as better scores thus representing more comfort than previous weeks."||||<0.05
74056605|NCT04837807|147664716|SUPERIORITY|OSDI scores were obtained across all three visits, baseline, week 1 and week 2. Lower OSDI scores indicate better eye health.|Mean Difference (Final Values)|10.5|STANDARD_DEVIATION|7.3|<|0.05|TWO_SIDED||||||ANOVA|This was a cross-over study, so there is really 30 subjects per group that was analyzed.||||||<0.05
74056606|NCT00635362|147664833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Fisher Exact|||||||0.35
74056607|NCT00635362|147664834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||Fisher Exact|||||||0.04
74056608|NCT00635362|147664835|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|0.0|||||Fisher Exact|||||||1.000
74056609|NCT00635362|147664836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED|0.0|||||Fisher Exact|||||||0.37
74100583|NCT02686138|147750773|SUPERIORITY||Risk Difference (RD)|16.18|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73881690|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.97||0.7816|TWO_SIDED|95.0|-2.18|1.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||1.64|-2.18|0.7816
73881691|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.97||0.0955|TWO_SIDED|95.0|-3.54|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.29|-3.54|0.0955
74056610|NCT00635362|147664837|SUPERIORITY_OR_OTHER_LEGACY|||||||1||0.0|||||Fisher Exact|||||||1.00
74100584|NCT02686138|147750774|SUPERIORITY||Risk Difference (RD)|9.17||||0.015|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.015
74100585|NCT02800642|147750797|OTHER||||||<|0.0001|||||||Exact one-sided 1-sample binomial test|||"The null hypothesis the proportion of participants with a ≥ 15-letter gain in BCVA at Week 76 is ≤ 40% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be true"||||<0.0001
74056611|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|3.04||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1||||0.32
74056612|NCT01484691|147664838|SUPERIORITY||Mean Difference (Final Values)|1.91||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir107||||0.38
74056613|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|0.47||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir128||||0.83
74056614|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|1.27||||0.42|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir141||||0.42
74056615|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|2.55||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir148b||||0.32
74056616|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|0.68||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir181b||||0.83
74056617|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|1.94||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir185||||0.38
74056618|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|2.77||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir194||||0.38
74056619|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|3.38||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir19a||||0.32
74056620|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir200a||||0.99
74100586|NCT02800642|147750798|OTHER||||||=|0.8822|||||||Exact one-sided 1-sample binomial test|||"The null hypothesis the proportion of participants with a mean treatment interval of ≥ 8 weeks is ≤ 50% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be true"||||=0.8822
74100587|NCT01004003|147750807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.437|||||TWO_SIDED|95.0|0.805|2.565|||||"Hazard ratio (HR) from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.565|0.805|
74100588|NCT01004003|147750810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.351|||||TWO_SIDED|95.0|0.779|2.343|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.343|0.779|
74056621|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|1.92||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir22||||0.38
74056622|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|1.57||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir223||||0.38
74056623|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|0.52||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir23a||||0.83
74056624|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|0.81||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir26a||||0.83
74056625|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|1.39||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir320b||||0.38
74100589|NCT01004003|147750811|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.877|||||TWO_SIDED|95.0|0.522|1.473|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.473|0.522|
74100590|NCT00517556|147750812|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
74056626|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|-0.92||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir598||||0.38
74056627|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|0.55||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir720||||0.83
74056628|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|-1.12||||0.3|TWO_SIDED||||||t-test, 2 sided|||mir1915||||0.30
74056629|NCT01484691|147664838|SUPERIORITY||Mean Difference (Net)|-1.35||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1978||||0.38
74056630|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|4.53||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1||||0.26
74056631|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|4.52||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir107||||0.26
74056632|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|3.57||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir128||||0.26
74056633|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|-0.58||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir141||||0.87
74100591|NCT00315731|147750897|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-120)|0.97|||||TWO_SIDED|90.0|0.85|1.12|||||Ratio of AUC(0-120) is the ratio of AUC(0-120) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.|||1.12|0.85|
74100592|NCT00315731|147750898|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-168)|0.96|||||TWO_SIDED|90.0|0.83|1.11|||||Ratio of AUC(0-168) is the ratio of AUC(0-168) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.|||1.11|0.83|
74100593|NCT00315731|147750899|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0 to infinity)|0.93|||||TWO_SIDED|90.0|0.78|1.1||||||||1.10|0.78|
73881692|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.2582|TWO_SIDED|95.0|-1.57|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.42|-1.57|0.2582
73881693|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.52||0.3448|TWO_SIDED|95.0|-0.53|1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.52|-0.53|0.3448
73881694|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.53||0.6587|TWO_SIDED|95.0|-0.81|1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.28|-0.81|0.6587
74056634|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|4.57||||0.29|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir148b||||0.29
74056635|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|1.56||||0.75|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir181b||||0.75
74056636|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|2.9||||0.36|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir185||||0.36
74056637|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|-0.36||||0.89|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir194||||0.89
74056638|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|2.48||||0.48|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir19a||||0.48
74056639|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|0.75||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir200a||||0.87
74056640|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|2.78||||0.53|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir22||||0.53
74100594|NCT00315731|147750900|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of Cmax|0.98|||||TWO_SIDED|90.0|0.87|1.11||||||||1.11|0.87|
74100595|NCT05819203|147750908|SUPERIORITY|||||||0.0013|||||||Wilcoxon (Mann-Whitney)|||Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.||||0.0013
73881695|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.8299|TWO_SIDED|95.0|-1.16|0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.93|-1.16|0.8299
74056641|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|1.91||||0.57|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir223||||0.57
74056642|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|4.27||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir23a||||0.26
74100596|NCT05819203|147750909|SUPERIORITY|||||||0.0209|||||||Cox survival regression and p Wald|||Comparison of the mean duration of common cold during the study between both groups.||||0.0209
74100597|NCT05819203|147750910|SUPERIORITY|||||||0.0399|||||||Cox survival regression and p Wald|||Comparison of the mean duration of impact of common cold on quality of life during the study between both groups.||||0.0399
73881696|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.8129|TWO_SIDED|95.0|-1.17|0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.92|-1.17|0.8129
74019762|NCT05384041|147591693|SUPERIORITY|||||||0.173|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.173
74019763|NCT05384041|147591693|SUPERIORITY|||||||0.142|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.142
74019764|NCT05384041|147591694|SUPERIORITY|||||||0.026|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.026
74019765|NCT05384041|147591694|SUPERIORITY|||||||0.241|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.241
74019766|NCT05384041|147591694|SUPERIORITY|||||||0.059|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.059
74019767|NCT05384041|147591694|SUPERIORITY|||||||0.478|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.478
74019768|NCT05384041|147591694|SUPERIORITY|||||||0.009|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.009
74019769|NCT05384041|147591694|SUPERIORITY|||||||0.729|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.729
74019770|NCT05384041|147591695|SUPERIORITY|||||||0.044|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.044
74019771|NCT05384041|147591695|SUPERIORITY|||||||0.067|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.067
74019772|NCT05384041|147591695|SUPERIORITY|||||||0.016|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.016
74019773|NCT05384041|147591695|SUPERIORITY|||||||0.006|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.006
74019774|NCT05384041|147591695|SUPERIORITY|||||||0.036|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.036
74019775|NCT05384041|147591695|SUPERIORITY|||||||0.016|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.016
74056643|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|1.66||||0.75|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir26a||||0.75
74056644|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|-0.91||||0.89|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir320b||||0.89
74056645|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|3.32||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir598||||0.26
74056646|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|-0.99||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir720||||0.87
74056647|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|-0.75||||0.74|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1915||||0.74
74056648|NCT01484691|147664839|SUPERIORITY||Mean Difference (Net)|3.77||||0.36|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1978||||0.36
74056649|NCT04095039|147664851|SUPERIORITY|||||||0.077||||||p-value is based on a sample that is less than 10% of the planned sample size (planned n=4,000)|Finkelstein-Schoenfeld method|||Primary outcome is for the individually randomized cohort since DSMB had concerns about selection bias for the cluster-randomized population due to differences in baseline characteristics that leaned towards the arm objectives.||||0.077
74019776|NCT05384041|147591695|SUPERIORITY|||||||0.914|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.914
74019777|NCT05384041|147591695|SUPERIORITY|||||||0.887|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.887
74019778|NCT05384041|147591695|SUPERIORITY|||||||0.791|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.791
74019779|NCT01360645|147591696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.0001|TWO_SIDED|95.0|-4.7|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||-1.54|-4.70|0.0001
74019780|NCT01360645|147591697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.21||||0.0002|TWO_SIDED|95.0|-4.87|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-1.54|-4.87|0.0002
74019781|NCT01360645|147591698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0372|TWO_SIDED|95.0|-0.86|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-0.03|-0.86|0.0372
74019782|NCT01360645|147591699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0349|TWO_SIDED|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-0.03|-0.88|0.0349
74019783|NCT01360645|147591700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.008|TWO_SIDED|95.0|-2.25|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.34|-2.25|0.0080
74019784|NCT01360645|147591700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.0045|TWO_SIDED|95.0|-2.91|-0.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.54|-2.91|0.0045
74019785|NCT01360645|147591700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63||||0.0001|TWO_SIDED|95.0|-3.96|-1.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-1.30|-3.96|0.0001
74019786|NCT01360645|147591700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.0004|TWO_SIDED|95.0|-4.01|-1.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-1.18|-4.01|0.0004
74019787|NCT01360645|147591700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.19||||0|TWO_SIDED|95.0|-4.68|-1.7|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-1.70|-4.68|0.0000
74019788|NCT01360645|147591701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0086|TWO_SIDED|95.0|-2.28|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.34|-2.28|0.0086
74019789|NCT01360645|147591701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.0149|TWO_SIDED|95.0|-2.74|-0.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.30|-2.74|0.0149
74019790|NCT01360645|147591701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42||||0.0006|TWO_SIDED|95.0|-3.78|-1.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-1.05|-3.78|0.0006
74019791|NCT01360645|147591701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52||||0.0009|TWO_SIDED|95.0|-4.0|-1.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-1.04|-4.00|0.0009
74100598|NCT05819203|147750911|SUPERIORITY|||||||0.0015|||||||Poisson regression|||||||0.0015
74100599|NCT05819203|147750912|SUPERIORITY||||||>|0.05||||||not significant|Poisson regression|||||||>0.05
74100600|NCT05819203|147750913|SUPERIORITY|||||||0.0029|||||||Poisson regression|||||||0.0029
74100601|NCT05819203|147750914|SUPERIORITY|||||||0.0006|||||||Poisson regression|||||||0.0006
74056650|NCT01738672|147664856|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
74056651|NCT01738672|147664857|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
74056652|NCT01738672|147664858|OTHER|||||||0.56|||||||t-test, 2 sided|||||||0.56
74056653|NCT03655951|147664862|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.20
74056654|NCT03655951|147664863|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
74056655|NCT03655951|147664864|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.48|||||||Regression, Linear|||||||.48
74056656|NCT03655951|147664865|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.36|||||||Regression, Linear|||||||.36
74056657|NCT03655951|147664866|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.48|||||||Regression, Linear|||||||.48
74056658|NCT03655951|147664867|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.41|||||||Regression, Linear|||||||.41
74056659|NCT03655951|147664868|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.87|||||||Regression, Linear|||||||.87
74056660|NCT03655951|147664869|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.8|||||||Regression, Linear|||||||.8
74056661|NCT03655951|147664870|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.32|||||||Regression, Linear|||||||.32
74100602|NCT05819203|147750915|SUPERIORITY|||||||0.0513|||||||Poisson regression|||||||0.0513
74100603|NCT05819203|147750916|SUPERIORITY|||||||0.0789|||||||Poisson regression|||||||0.0789
74056662|NCT03655951|147664871|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
74056663|NCT03655951|147664872|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.05|||||||Regression, Linear|||||||.05
74056664|NCT03655951|147664873|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.04|||||||Regression, Linear|||||||.04
74056665|NCT03655951|147664874|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.42|||||||Regression, Linear|||||||.42
74056666|NCT03655951|147664875|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
74056667|NCT03655951|147664876|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.0003|||||||Regression, Linear|||||||.0003
74056668|NCT03655951|147664877|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.97|||||||Regression, Linear|||||||.97
74056669|NCT03655951|147664878|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.08|||||||Regression, Linear|||||||.08
74100604|NCT05819203|147750917|SUPERIORITY||||||<|0.0001|||||||Poisson regression|||||||<0.0001
74100605|NCT05819203|147750918|SUPERIORITY|Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.||||||0.0034|||||||t-test, 2 sided|||||||0.0034
74100606|NCT04784533|147750924|SUPERIORITY||Difference in percentages|16.2|||||TWO_SIDED|95.0|5.5|26.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||26.8|5.5|
74100607|NCT04784533|147750924|SUPERIORITY||Difference in percentages|12.1|||||TWO_SIDED|95.0|1.3|22.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||22.9|1.3|
74100608|NCT04784533|147750924|SUPERIORITY||Difference in percentages|26.4|||||TWO_SIDED|95.0|15.4|37.5|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||37.5|15.4|
74100609|NCT04784533|147750924|SUPERIORITY||Difference in percentages|19.9|||||TWO_SIDED|95.0|8.5|31.3|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.3|8.5|
74100610|NCT04784533|147750925|SUPERIORITY||Difference in percentages|0.6|||||TWO_SIDED|95.0|-2.7|3.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 8||3.9|-2.7|
74100611|NCT04784533|147750925|SUPERIORITY||Difference in percentages|10.6|||||TWO_SIDED|95.0|3.3|17.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||17.9|3.3|
74100612|NCT04784533|147750925|SUPERIORITY||Difference in percentages|14.0|||||TWO_SIDED|95.0|5.3|22.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||22.8|5.3|
74100613|NCT04784533|147750925|SUPERIORITY||Difference in percentages|19.4|||||TWO_SIDED|95.0|9.2|29.5|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||29.5|9.2|
74100614|NCT04784533|147750925|SUPERIORITY||Difference in percentages|20.8|||||TWO_SIDED|95.0|9.8|31.7|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.7|9.8|
74100615|NCT04784533|147750926|SUPERIORITY||Least Square (LS) Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|-2.8|1.8|||||LS means,standard error(SE),and confidence intervals(CIs) are based on mixed model repeated measures(MMRM)analysis with effects for treatment,visit,treatment-by-visit interaction,and baseline value.The Model uses an unstructured covariance structure.|Week 4||1.8|-2.8|
74100616|NCT04784533|147750926|SUPERIORITY||LS Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-11.9|-2.7|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 8||-2.7|-11.9|
74100617|NCT04784533|147750926|SUPERIORITY||LS Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-19.3|-5.5|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 12||-5.5|-19.3|
74100618|NCT04784533|147750926|SUPERIORITY||LS Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-22.2|-6.9|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 16||-6.9|-22.2|
74100619|NCT04784533|147750926|SUPERIORITY||LS Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-23.7|-7.2|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 20||-7.2|-23.7|
74100620|NCT04784533|147750926|SUPERIORITY||LS Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|4.36|||TWO_SIDED|95.0|-24.0|-6.8|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 24||-6.8|-24.0|
74100621|NCT04784533|147750927|SUPERIORITY||Difference in percentages|20.9|||||TWO_SIDED|95.0|9.9|31.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||31.8|9.9|
74100622|NCT04784533|147750927|SUPERIORITY||Difference in percentages|13.8|||||TWO_SIDED|95.0|2.5|25.2|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||25.2|2.5|
74100623|NCT04784533|147750927|SUPERIORITY||Difference in percentages|15.6|||||TWO_SIDED|95.0|4.1|27.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||27.0|4.1|
74100624|NCT04784533|147750927|SUPERIORITY||Difference in percentages|14.4|||||TWO_SIDED|95.0|2.9|25.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||25.9|2.9|
74100625|NCT04784533|147750928|SUPERIORITY||Difference in percentages|22.9|||||TWO_SIDED|95.0|11.9|34.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||34.0|11.9|
74100626|NCT04784533|147750928|SUPERIORITY||Difference in percentages|21.9|||||TWO_SIDED|95.0|10.7|33.1|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||33.1|10.7|
74100627|NCT04784533|147750928|SUPERIORITY||Difference in percentages|22.6|||||TWO_SIDED|95.0|11.2|33.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||33.9|11.2|
74100628|NCT04784533|147750928|SUPERIORITY||Difference in percentages|19.5|||||TWO_SIDED|95.0|8.1|31.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.0|8.1|
74100629|NCT04784533|147750929|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.9|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 12||-0.3|-0.9|
74100630|NCT04784533|147750929|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.1|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 16||-0.4|-1.1|
74100631|NCT04784533|147750929|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-1.2|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 20||-0.4|-1.2|
74056670|NCT03655951|147664879|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.7|||||||Regression, Linear|||||||.70
74056671|NCT03655951|147664880|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
74056672|NCT03655951|147664881|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.29|||||||Regression, Linear|||||||.29
74056673|NCT03655951|147664882|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.36|||||||Regression, Linear|||||||.36
74056674|NCT03655951|147664883|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.61|||||||Regression, Linear|||||||.61
74056675|NCT03655951|147664884|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.72|||||||Regression, Linear|||||||.72
74056676|NCT03655951|147664885|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.05|||||||Regression, Linear|||||||.05
74056677|NCT03655951|147664886|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
74056678|NCT03655951|147664887|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
74056679|NCT03655951|147664888|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
74056680|NCT03655951|147664889|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.27|||||||Regression, Linear|||||||.27
74100632|NCT04784533|147750929|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.2|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 24||-0.3|-1.2|
74100633|NCT04784533|147750930|SUPERIORITY||Least Square (LS) Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.7|-0.1|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 12||-0.1|-0.7|
74056681|NCT03655951|147664890|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.83|||||||Regression, Linear|||||||.83
74056682|NCT03655951|147664891|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.0001|||||||Regression, Linear|||||||.0001
74056683|NCT03655951|147664892|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.20
74056684|NCT03655951|147664893|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
74056685|NCT03655951|147664894|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.62|||||||Regression, Linear|||||||.62
74056686|NCT03655951|147664895|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.29|||||||Regression, Linear|||||||.29
74056687|NCT03655951|147664896|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.14|||||||Regression, Linear|||||||.14
74100634|NCT04784533|147750930|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.0|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 16||-0.3|-1.0|
74056688|NCT03655951|147664897|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.008|||||||Regression, Linear|||||||.008
74056689|NCT03655951|147664898|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
74056690|NCT03655951|147664899|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
74056691|NCT03655951|147664900|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
74056692|NCT03655951|147664901|EQUIVALENCE|Binary outcomes were assessed with logistic regression.||||||0.4|||||||Regression, Logistic|||||||.4
74056693|NCT03655951|147664902|EQUIVALENCE|Binary outcomes were assessed with logistic regression.||||||0.02|||||||Regression, Logistic|||||||.02
74056694|NCT03655951|147664903|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.27|||||||Regression, Linear|||||||.27
74056695|NCT03655951|147664904|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.31|||||||Regression, Linear|||||||.31
74056696|NCT03655951|147664905|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
74056697|NCT03655951|147664906|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.89|||||||Regression, Linear|||||||.89
74056698|NCT03655951|147664907|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.41|||||||Regression, Linear|||||||.41
74056699|NCT03655951|147664908|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.93|||||||Regression, Linear|||||||.93
74056700|NCT03655951|147664909|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.83|||||||Regression, Linear|||||||.83
74056701|NCT03655951|147664910|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.04|||||||Regression, Linear|||||||.04
74056702|NCT03655951|147664911|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.13|||||||Regression, Linear|||||||.13
74056703|NCT03655951|147664912|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.56|||||||Regression, Linear|||||||.56
74056704|NCT03655951|147664913|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.96|||||||Regression, Linear|||||||.96
74056705|NCT03655951|147664914|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.35|||||||Regression, Linear|||||||.35
74056706|NCT03655951|147664915|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.24|||||||Regression, Linear|||||||.24
74056707|NCT03655951|147664916|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.2
74056708|NCT03655951|147664917|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.18|||||||Regression, Linear|||||||.18
74056709|NCT03655951|147664918|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.67|||||||Regression, Linear|||To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||.67
74056710|NCT03655951|147664919|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.57|||||||Regression, Linear|||||||.57
74056711|NCT03655951|147664920|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.65|||||||Regression, Linear|||||||.65
74100635|NCT04784533|147750930|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.2|-0.5|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 20||-0.5|-1.2|
74056712|NCT03655951|147664921|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.84|||||||Regression, Linear|||||||.84
74056713|NCT03655951|147664922|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
74056714|NCT03655951|147664923|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.65|||||||Regression, Linear|||||||.65
74056715|NCT03655951|147664924|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
74056716|NCT03655951|147664925|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.95|||||||Regression, Linear|||||||.95
74056717|NCT03655951|147664926|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.47|||||||Regression, Linear|||||||.47
74056718|NCT03655951|147664927|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.003|||||||Regression, Linear|||||||.003
74056719|NCT03655951|147664928|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.77|||||||Regression, Linear|||||||.77
74056720|NCT03655951|147664929|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.|||||<|0.001|||||||Regression, Linear|||||||<.001
74056721|NCT03655951|147664930|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.06|||||||Regression, Linear|||||||.06
74056722|NCT03655951|147664931|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.91|||||||Regression, Linear|||||||.91
74056723|NCT03655951|147664932|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.95|||||||Regression, Linear|||||||.95
74056724|NCT03655951|147664933|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.12|||||||Regression, Linear|||||||.12
74056725|NCT03655951|147664934|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.98|||||||Regression, Linear|||||||.98
74056726|NCT03655951|147664935|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.57|||||||Regression, Linear|||||||.57
74056727|NCT03655951|147664936|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.98|||||||Regression, Linear|||||||.98
74056728|NCT03655951|147664937|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.07|||||||Regression, Linear|||||||.07
74056729|NCT03655951|147664938|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
74056730|NCT03655951|147664939|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.15|||||||Regression, Linear|||||||.15
74056731|NCT00976521|147664949|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.||||0.034
74100636|NCT04784533|147750930|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-1.2|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 24||-0.4|-1.2|
73881697|NCT03192176|147297635|SUPERIORITY||LSMean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.52||0.213|TWO_SIDED|95.0|-0.37|1.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.66|-0.37|0.2130
74056732|NCT00976521|147664950|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.||||0.51
74056733|NCT02383966|147664971|OTHER||Hazard Ratio (HR)|0.566|||||TWO_SIDED|95.0|0.4|0.803||||||||0.803|0.400|
74056734|NCT02383966|147664972|OTHER||Hazard Ratio (HR)|0.568|||||TWO_SIDED|95.0|0.406|0.795||||||||0.795|0.406|
74056735|NCT02383966|147664973|OTHER||Hazard Ratio (HR)|0.705|||||TWO_SIDED|95.0|0.502|0.991||||||||0.991|0.502|
74100637|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 12||-0.2|-0.7|
74100638|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 16||-0.2|-0.7|
74056736|NCT02383966|147664974|OTHER||Odds Ratio (OR)|2.76|||||TWO_SIDED|95.0|1.52|5.45||||||||5.45|1.52|
74056737|NCT02383966|147664975|OTHER||Odds Ratio (OR)|2.14|||||TWO_SIDED|95.0|1.15|3.95||||||||3.95|1.15|
74056738|NCT02163759|147664978|SUPERIORITY||Difference in Remission Rates|12.3||||0.0173|TWO_SIDED|95.0|1.59|20.6||The threshold for statistical significance was a p-value \<0.05.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|The null hypothesis (H0): the percentage of participants achieving remission at Week 10 was the same in both the placebo and etrolizumab arms. The alternative hypothesis (H1): the percentage of participants achieving remission at Week 10 was not the same in the placebo and etrolizumab arms.||20.60|1.59|0.0173
74056739|NCT02163759|147664979|SUPERIORITY||Difference in Remission Rates|-3.1||||0.5055|TWO_SIDED|95.0|-12.61|6.37||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||6.37|-12.61|0.5055
74056740|NCT02163759|147664980|SUPERIORITY||Difference in Remission Rates|-5.0||||1|TWO_SIDED|95.0|-11.66|1.75||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||1.75|-11.66|1
74056741|NCT02163759|147664981|SUPERIORITY||Difference in Response Rates|6.9||||0.4434|TWO_SIDED|95.0|-7.03|20.62||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||20.62|-7.03|0.4434
74056742|NCT02163759|147664981|SUPERIORITY||Difference in Response Rates|4.8||||0.4122|TWO_SIDED|95.0|-6.72|16.07||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||16.07|-6.72|0.4122
74100639|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 20||-0.3|-0.8|
74100640|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 24||-0.2|-0.8|
74100641|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 12||-0.3|-0.8|
74100642|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.7|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 16||-0.3|-0.7|
74100643|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 20||-0.3|-0.8|
74100644|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 24||-0.3|-0.8|
74100645|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 12||-0.2|-0.8|
74100646|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.6|-0.1|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 16||-0.1|-0.6|
74100647|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.7|-0.1|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 20||-0.1|-0.7|
74100648|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 24||-0.2|-0.7|
74100649|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 12||-0.2|-0.7|
74100650|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 16||-0.2|-0.7|
74100651|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 20||-0.2|-0.7|
74100652|NCT04784533|147750931|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 24||-0.3|-0.8|
74100653|NCT02521376|147750938|OTHER||Geometric Mean Ratio (GMR)|43.69|||||TWO_SIDED|90.0|24.59|77.62||||||||77.62|24.59|
74100654|NCT02521376|147750938|OTHER||GMR|233.63|||||TWO_SIDED|90.0|141.85|384.79||||||||384.79|141.85|
74100655|NCT02521376|147750938|OTHER||GMR|219.2|||||TWO_SIDED|90.0|139.74|343.84||||||||343.84|139.74|
74100656|NCT02521376|147750938|OTHER||GMR|108.5|||||TWO_SIDED|90.0|77.2|152.48||||||||152.48|77.20|
74100657|NCT02521376|147750939|OTHER||GMR|55.71|||||TWO_SIDED|90.0|34.7|89.42||||||||89.42|34.70|
74100658|NCT02521376|147750939|OTHER||GMR|211.94|||||TWO_SIDED|90.0|132.49|339.03||||||||339.03|132.49|
74056743|NCT02163759|147664982|SUPERIORITY||Difference in Response Rates|1.2||||1|TWO_SIDED|95.0|-6.98|9.26||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.26|-6.98|1
74056744|NCT02163759|147664983|SUPERIORITY||Difference in Response Rates|17.9||||0.0173|TWO_SIDED|95.0|4.49|29.5||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||29.50|4.49|0.0173
74056745|NCT02163759|147664983|SUPERIORITY||Difference in Response Rates|7.4||||0.1886|TWO_SIDED|95.0|-3.77|18.32||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||18.32|-3.77|0.1886
74056746|NCT02163759|147664984|SUPERIORITY||Difference in Response Rates|1.9||||1|TWO_SIDED|95.0|-6.04|9.88||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.88|-6.04|1
74056747|NCT02163759|147664985|SUPERIORITY||Difference in Remission Rates|13.8||||0.1347|TWO_SIDED|95.0|2.97|22.15||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||22.15|2.97|0.1347
74056748|NCT02163759|147664985|SUPERIORITY||Difference in Remission Rates|0.5||||0.9138|TWO_SIDED|95.0|-8.95|9.92||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.92|-8.95|0.9138
74056749|NCT02163759|147664986|SUPERIORITY||Difference in Remission Rates|-3.5||||1|TWO_SIDED|95.0|-10.27|3.3||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||3.30|-10.27|1
74056750|NCT02163759|147664987|SUPERIORITY||Difference in Remission Rates|26.3||||0.0173|TWO_SIDED|95.0|12.1|37.86||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||37.86|12.10|0.0173
74056751|NCT02163759|147664987|SUPERIORITY||Difference in Remission Rates|13.2||||0.0313|TWO_SIDED|95.0|0.93|24.94||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||24.94|0.93|0.0313
74100659|NCT02521376|147750939|OTHER||GMR|171.33|||||TWO_SIDED|90.0|108.17|271.37||||||||271.37|108.17|
74100660|NCT02521376|147750939|OTHER||GMR|107.35|||||TWO_SIDED|90.0|72.71|158.51||||||||158.51|72.71|
74100661|NCT00676780|147750944|SUPERIORITY_OR_OTHER||||||=|0.027||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.027
74100662|NCT00676780|147750945|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.023
74100663|NCT00676780|147750946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis is no change, i.e. median change = 0.0||||<0.001
74056752|NCT02163759|147664988|SUPERIORITY||Difference in Remission Rates|-0.3||||1|TWO_SIDED|95.0|-9.13|8.45||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||8.45|-9.13|1
74056753|NCT02163759|147664989|SUPERIORITY|||||||0.4434||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.4434
74056754|NCT02163759|147664989|SUPERIORITY|||||||0.3374||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.3374
74056755|NCT02163759|147664990|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
74056756|NCT02163759|147664991|SUPERIORITY|||||||0.4434||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.4434
74056757|NCT02163759|147664991|SUPERIORITY|||||||0.6367||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.6367
74056758|NCT02163759|147664992|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
74100664|NCT01613313|147750947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|||||||No p value||This is a proof of concept dose escalation study. No power justification has been implemented. Descriptive data provided for each arm.||||
74100665|NCT01613313|147750948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|||||||||This is a proof of concept dose escalation study. No power of justification was implemented. Descriptive statistics was provided for each arm only.||||
74100666|NCT00708227|147750964|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
74100667|NCT00708227|147750965|SUPERIORITY|||||||0.15|||||||ANOVA|||||||0.15
74100668|NCT00708227|147750966|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
74056759|NCT02163759|147664993|SUPERIORITY||Mean Difference (Net)|-0.7||||0.3708|TWO_SIDED|95.0|-2.4|0.9||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.9|-2.4|0.3708
74100669|NCT04007991|147750970|SUPERIORITY||Difference in Least Square Mean|-3.44|STANDARD_ERROR_OF_MEAN|1.351|=|0.011|TWO_SIDED|95.0|-6.09|-0.79||Change from baseline in YGTSS score as a continuous variable was based on mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) model with an unstructured covariance matrix.|ANCOVA|||||-0.79|-6.09|=0.011
74100670|NCT02462291|147750980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||1|TWO_SIDED|95.0|-7.9|5.4|||ANOVA|||Baseline||5.4|-7.9|1
74100671|NCT02462291|147750980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.3|||<|0.01|TWO_SIDED|95.0|26.4|40.2|||ANOVA|||After the treatment||40.2|26.4|<0.01
74100672|NCT02462291|147750980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.5|||<|0.01|TWO_SIDED|95.0|-38.2|-24.8|||ANOVA|||PRE Vs POST||-24.8|-38.2|<0.01
74100673|NCT02462291|147750980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1||||1|TWO_SIDED|95.0|-3.7|9.9|||ANOVA|||PRE Vs POST||9.9|-3.7|1
74100674|NCT02462291|147750981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||1|TWO_SIDED|95.0|-0.8|0.5|||ANOVA|||Baseline||0.5|-0.8|1
74100675|NCT02462291|147750981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94|||<|0.01|TWO_SIDED|95.0|-2.6|-1.2|||ANOVA|||After the treatment||-1.2|-2.6|<0.01
74100676|NCT02462291|147750981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.01|TWO_SIDED|95.0|0.28|1.61|||ANOVA|||PRE Vs POST||1.61|0.28|<0.01
74100677|NCT02462291|147750981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.01|TWO_SIDED|95.0|-1.52|-0.17|||ANOVA|||PRE Vs POST||-0.17|-1.52|<0.01
74056760|NCT02163759|147664993|SUPERIORITY||Mean Difference (Net)|-0.5||||0.4477|TWO_SIDED|95.0|-1.8|0.8||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.8|-1.8|0.4477
74056761|NCT02163759|147664994|SUPERIORITY||Mean Difference (Net)|-1.0||||1|TWO_SIDED|95.0|-2.1|0.2||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.2|-2.1|1
74056762|NCT02163759|147664994|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-1.2|0.7||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.7|-1.2|1
74056763|NCT02163759|147664995|SUPERIORITY||Mean Difference (Net)|-0.2||||0.6356|TWO_SIDED|95.0|-0.9|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-0.9|0.6356
74100678|NCT02462291|147750982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||=|0.84|TWO_SIDED|95.0|-3.6|2.1|||ANOVA|||Baseline||2.1|-3.6|= 0.84
74100679|NCT02462291|147750982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|||=|0.9|TWO_SIDED|95.0|-4.3|1.7|||ANOVA|||After the treatment||1.7|-4.3|= 0.9
74100680|NCT02462291|147750982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.88|TWO_SIDED|95.0|-3.14|2.69|||ANOVA|||PRE Vs POST||2.69|-3.14|0.88
74100681|NCT02462291|147750982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.89|TWO_SIDED|95.0|-3.73|2.16|||ANOVA|||PRE Vs POST||2.16|-3.73|0.89
74100682|NCT02462291|147750983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||0.9|TWO_SIDED|95.0|-5.48|2.73|||ANOVA|||Baseline||2.73|-5.48|0.9
74100683|NCT02462291|147750983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.62||||0.59|TWO_SIDED|95.0|-1.6|6.9|||ANOVA|||After the treatment||6.90|-1.60|0.59
74100684|NCT02462291|147750983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.34|TWO_SIDED|95.0|-7.15|1.16|||ANOVA|||PRE Vs POST||1.16|-7.15|0.34
74100685|NCT02462291|147750983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.9|TWO_SIDED|95.0|-3.17|5.23|||ANOVA|||PRE Vs POST||5.23|-3.17|0.9
74100686|NCT02462291|147750984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.83|TWO_SIDED|95.0|-1.41|2.14|||ANOVA|||Baseline||2.14|-1.41|0.83
74100687|NCT02462291|147750984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.69|||<|0.01|TWO_SIDED|95.0|0.84|4.53|||ANOVA|||After the treatment||4.53|0.84|<0.01
74100688|NCT02462291|147750984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14||||0.01|TWO_SIDED|95.0|-3.94|-0.34|||ANOVA|||PRE Vs POST||-0.34|-3.94|0.010
74100689|NCT02462291|147750984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.84|TWO_SIDED|95.0|-1.64|2.0|||ANOVA|||PRE Vs POST||2.00|-1.64|0.84
74100690|NCT02462291|147750985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.11|TWO_SIDED|95.0|-0.16|2.95|||ANOVA|||Baseline||2.95|-0.16|0.11
74019792|NCT01360645|147591701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.28||||0|TWO_SIDED|95.0|-4.84|-3.28|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-3.28|-4.84|0.0000
74019793|NCT01360645|147591702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.0022|TWO_SIDED|95.0|-0.38|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis for Week 9||-0.08|-0.38|0.0022
74019794|NCT01360645|147591702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.0115|TWO_SIDED|95.0|-0.38|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10||-0.05|-0.38|0.0115
74019795|NCT01360645|147591702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.0255|TWO_SIDED|95.0|-0.41|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11||-0.03|-0.41|0.0255
74019796|NCT01360645|147591702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0005|TWO_SIDED|95.0|-0.57|-0.16|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12||-0.16|-0.57|0.0005
74019797|NCT01360645|147591702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0001|TWO_SIDED|95.0|-0.62|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13||-0.20|-0.62|0.0001
74019798|NCT01360645|147591702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0005|TWO_SIDED|95.0|-0.6|-0.17|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14||-0.17|-0.60|0.0005
74100691|NCT02462291|147750985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.7|TWO_SIDED|95.0|-0.81|2.41|||ANOVA|||After the treatment||2.41|-0.81|0.7
74100692|NCT02462291|147750985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.88|TWO_SIDED|95.0|-1.17|1.98|||ANOVA|||PRE Vs POST||1.98|-1.17|0.88
74100693|NCT02462291|147750985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.95|TWO_SIDED|95.0|-1.78|1.39|||ANOVA|||PRE Vs POST||1.39|-1.78|0.95
74100694|NCT02462291|147750986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.95|TWO_SIDED|95.0|-0.67|0.4|||ANOVA|||Baseline||0.40|-0.67|0.95
74100695|NCT02462291|147750986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.23|TWO_SIDED|95.0|-0.12|0.99|||ANOVA|||After the treatment||0.99|-0.12|0.23
74100696|NCT02462291|147750986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.96|TWO_SIDED|95.0|-0.65|0.44|||ANOVA|||PRE Vs POST||0.44|-0.65|0.96
74100697|NCT02462291|147750986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.15|TWO_SIDED|95.0|-0.08|1.01|||ANOVA|||PRE Vs POST||1.01|-0.08|0.15
74100698|NCT02462291|147750987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.84|TWO_SIDED|95.0|-1.14|1.27|||ANOVA|||Baseline||1.27|-1.14|0.84
74100699|NCT02462291|147750987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.81|TWO_SIDED|95.0|-0.96|1.54|||ANOVA|||After the treatment||1.54|-0.96|0.81
74100700|NCT02462291|147750987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.86|TWO_SIDED|95.0|-1.71|0.74|||ANOVA|||PRE Vs POST||0.74|-1.71|0.86
73881698|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.51||0.4131|TWO_SIDED|95.0|-1.42|0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.59|-1.42|0.4131
74100701|NCT02462291|147750987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.75|TWO_SIDED|95.0|-1.49|0.97|||ANOVA|||PRE Vs POST||0.97|-1.49|0.75
74056764|NCT02163759|147664995|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1253|TWO_SIDED|95.0|-1.0|0.1||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.1|-1.0|0.1253
74056765|NCT02163759|147664996|SUPERIORITY||Mean Difference (Net)|-0.5||||1|TWO_SIDED|95.0|-1.0|0.0||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.0|-1.0|1
74100702|NCT02462291|147750988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7||||0.94|TWO_SIDED|95.0|-74.4|44.9|||ANOVA|||Baseline||44.9|-74.4|0.94
74100703|NCT02462291|147750988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.36||||0.87|TWO_SIDED|95.0|-53.47|70.2|||ANOVA|||After the treatment||70.20|-53.47|0.87
74100704|NCT02462291|147750988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7||||0.78|TWO_SIDED|95.0|-90.19|30.78|||ANOVA|||PRE Vs POST||30.78|-90.19|0.78
74100705|NCT02462291|147750988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.84|TWO_SIDED|95.0|-67.7|54.5|||ANOVA|||PRE Vs POST||54.5|-67.7|0.84
74100706|NCT02462291|147750989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.74|TWO_SIDED|95.0|-3.73|4.56|||ANOVA|||Baseline||4.56|-3.73|0.74
74100707|NCT02462291|147750989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25||||0.82|TWO_SIDED|95.0|-5.54|3.04|||ANOVA|||After the treatment||3.04|-5.54|0.82
74100708|NCT02462291|147750989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.59|TWO_SIDED|95.0|-3.57|4.82|||ANOVA|||PRE Vs POST||4.82|-3.57|0.59
74100709|NCT02462291|147750989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.69|TWO_SIDED|95.0|-5.28|3.19|||ANOVA|||PRE Vs POST||3.19|-5.28|0.69
74100710|NCT02462291|147750990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.9|TWO_SIDED|95.0|-0.64|1.09|||ANOVA|||Baseline||1.09|-0.64|0.9
74100711|NCT02462291|147750990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|||<|0.01|TWO_SIDED|95.0|1.96|3.76|||ANOVA|||After the treatment||3.76|1.96|<0.01
74100712|NCT02462291|147750990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92|||<|0.01|TWO_SIDED|95.0|-3.8|-2.04|||ANOVA|||PRE Vs POST||-2.04|-3.80|<0.01
74100713|NCT02462291|147750990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.88|TWO_SIDED|95.0|-1.17|0.59|||ANOVA|||PRE Vs POST||0.59|-1.17|0.88
74100714|NCT02462291|147750991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.83|TWO_SIDED|95.0|-0.72|0.37|||ANOVA|||Baseline||0.37|-0.72|0.83
74100715|NCT02462291|147750991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.005|TWO_SIDED|95.0|0.15|1.29|||ANOVA|||After the treatment||1.29|0.15|0.005
74100716|NCT02462291|147750991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.013|TWO_SIDED|95.0|-1.21|-0.09|||ANOVA|||PRE Vs POST||-0.09|-1.21|0.013
74100717|NCT02462291|147750991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.87|TWO_SIDED|95.0|-0.31|0.81|||ANOVA|||PRE Vs POST||0.81|-0.31|0.87
74100718|NCT02462291|147750992|SUPERIORITY_OR_OTHER||Chi-squared value|0.542|||=|0.91|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.082; 3 degrees of freedom|||||= 0.910
74100719|NCT02462291|147750993|SUPERIORITY_OR_OTHER||Chi-squared value|17.73|||<|0.001|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.965; 3 degrees of freedom|||||<0.001
74100720|NCT02462291|147750994|SUPERIORITY_OR_OTHER||Chi-squared value|5.749||||0.124|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.488; 3 degrees of freedom|||||0.124
74100721|NCT02462291|147750995|SUPERIORITY_OR_OTHER||Chi-squared value|0.008||||1|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.050; 3 degrees of freedom|||||1
74019799|NCT01360645|147591703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.001|TWO_SIDED|95.0|-0.4|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 9||-0.10|-0.40|0.0010
74019800|NCT01360645|147591703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.029|TWO_SIDED|95.0|-0.37|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10||-0.02|-0.37|0.0290
74019801|NCT01360645|147591703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0422|TWO_SIDED|95.0|-0.4|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11||-0.01|-0.40|0.0422
74056766|NCT02163759|147664996|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-0.7|0.1||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.1|-0.7|1
74056767|NCT02163759|147664997|SUPERIORITY||Difference in Remission Rates|10.9||||0.0364|TWO_SIDED|95.0|-0.08|19.48||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||19.48|-0.08|0.0364
74056768|NCT02163759|147664997|SUPERIORITY||Difference in Remission Rates|-4.5||||0.3383|TWO_SIDED|95.0|-14.1|5.07||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||5.07|-14.10|0.3383
74056769|NCT02163759|147664998|SUPERIORITY||Difference in Remission Rates|6.2||||0.09|TWO_SIDED|95.0|-3.33|12.3||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||12.30|-3.33|0.0900
74056770|NCT02163759|147664998|SUPERIORITY||Difference in Remission Rates|-3.6||||0.3217|TWO_SIDED|95.0|-11.07|3.78||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||3.78|-11.07|0.3217
74056771|NCT02163759|147664999|SUPERIORITY||Difference in Adjusted Means|1.3||||0.7919|TWO_SIDED|95.0|-8.3|10.8||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||10.8|-8.3|0.7919
74056772|NCT02163759|147664999|SUPERIORITY||Difference in Adjusted Means|-0.8||||0.8327|TWO_SIDED|95.0|-8.7|7.0||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||7.0|-8.7|0.8327
74056773|NCT02883400|147665005|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
74056774|NCT00333437|147665006|SUPERIORITY_OR_OTHER||Change from Baseline|0.1786|STANDARD_DEVIATION|0.1613||0.026|TWO_SIDED|95.0|0.0294|0.3277||Not adjusted|t-test, 2 sided|||H(0): post-pre FVC (liters) = 0||0.3277|0.0294|0.026
74056775|NCT00333437|147665007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|8.1035||0.3652|TWO_SIDED|95.0|-10.49|4.4945||significant p\<0.05|t-test, 2 sided|||H(0): Post-pre neutrophil count = 0||4.4945|-10.49|0.3652
74056776|NCT00333437|147665007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.286|STANDARD_DEVIATION|16.358||0.3485|TWO_SIDED|95.0|-21.41|8.8426||significant p\<0.05|t-test, 2 sided|||H(0): post-pre eosinophil count = 0||8.8426|-21.41|0.3485
74100722|NCT02462291|147750996|SUPERIORITY_OR_OTHER||Chi-squared value|1.049||||0.789|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.116; 3 degrees of freedom|||||0.789
74100723|NCT02111603|147751007|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of on-treatment total fecal bile acid excretion with baseline total fecal bile acid excretion.||||0.012
74019802|NCT01360645|147591703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0003|TWO_SIDED|95.0|-0.61|-0.18|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12||-0.18|-0.61|0.0003
74019803|NCT01360645|147591703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0002|TWO_SIDED|95.0|-0.64|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13||-0.20|-0.64|0.0002
74019804|NCT01360645|147591703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0003|TWO_SIDED|95.0|-0.65|-0.19|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14||-0.19|-0.65|0.0003
74019805|NCT01360645|147591704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0229|TWO_SIDED|95.0|-0.25|-0.02|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.02|-0.25|0.0229
74019806|NCT01360645|147591704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0459|TWO_SIDED|95.0|-0.28|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.00|-0.28|0.0459
74019807|NCT01360645|147591704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0097|TWO_SIDED|95.0|-0.37|-0.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-0.05|-0.37|0.0097
74056777|NCT00333437|147665009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|264.26|STANDARD_DEVIATION|194.66||0.0115|TWO_SIDED|95.0|84.256|444.32||Significant p\<0.05|t-test, 2 sided|Not adjusted||H(0): post-pre walk distance = 0||444.32|84.256|0.0115
74056778|NCT00333437|147665010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8643|STANDARD_DEVIATION|1.5013||0.0167|TWO_SIDED|95.0|0.4758|3.2527||significant p\<0.05|t-test, 2 sided|||H(0): Post-pre DLCO = 0||3.2527|0.4758|0.0167
74056779|NCT03022526|147665070|SUPERIORITY|||||||0.7463|||||||t-test, 2 sided|||||||0.7463
74056780|NCT03022526|147665071|SUPERIORITY|||||||0.5764|||||||t-test, 2 sided|||||||0.5764
74056781|NCT03022526|147665072|SUPERIORITY|||||||0.7169|||||||t-test, 2 sided|||||||0.7169
74056782|NCT03022526|147665073|SUPERIORITY|||||||0.4226|||||||t-test, 2 sided|||||||0.4226
74056783|NCT03022526|147665074|SUPERIORITY|||||||0.6873|||||||t-test, 2 sided|||||||0.6873
74056784|NCT03022526|147665075|SUPERIORITY|||||||0.0452|||||||Chi-squared|||||||0.0452
74056785|NCT03022526|147665076|SUPERIORITY|||||||0.0899|||||||Chi-squared|||||||0.0899
74056786|NCT03022526|147665077|SUPERIORITY|||||||0.1265|||||||Chi-squared|||||||0.1265
74056787|NCT03022526|147665078|SUPERIORITY|||||||0.0328|||||||t-test, 2 sided|||||||0.0328
74056788|NCT03022526|147665079|SUPERIORITY|||||||0.6824|||||||t-test, 2 sided|||||||0.6824
74056789|NCT03022526|147665080|SUPERIORITY|||||||0.449|||||||t-test, 2 sided|||||||0.449
74056790|NCT03022526|147665081|SUPERIORITY|||||||0.5996|||||||t-test, 2 sided|||||||0.5996
74056791|NCT03022526|147665082|SUPERIORITY|||||||0.8009|||||||t-test, 2 sided|||||||0.8009
74056792|NCT03022526|147665083|SUPERIORITY|||||||0.5422|||||||t-test, 2 sided|||||||0.5422
74056793|NCT03022526|147665084|SUPERIORITY|||||||0.7374|||||||t-test, 2 sided|||||||0.7374
74056794|NCT00451191|147665088|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Simon's optimal two-stage design|||Simon's optimal two-stage design was applied to determine whether there was sufficient activity at either of the two dose levels to warrant further investigation. Each patient was considered either a successful or failed response. The response rate or proportion of patients treated successfully was examined in two stages. At both stages, the two dose levels were compared to pre-determined critical cut-off values. Sample size was based on significance level α=0.05 and power 90%.||||<0.05
74100724|NCT03106987|147751013|OTHER||Hazard Ratio (HR)|0.566||||0.022|TWO_SIDED|95.0|0.372|0.868|||Stratified log-rank||Hazard Ratio (Cox Proportional Hazards model)|||0.868|0.372|0.0220
74100725|NCT03106987|147751013|OTHER||Hazard Ratio (HR)|0.43||||0.0023|TWO_SIDED|95.0|0.264|0.708|||Stratified log-rank||Hazard Ratio (Cox Proportional Hazards model)|||0.708|0.264|0.0023
74019808|NCT01360645|147591704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0038|TWO_SIDED|95.0|-0.42|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-0.08|-0.42|0.0038
74056795|NCT02777554|147665117|EQUIVALENCE|Equivalent exposure of the QD formulation to the BID tablet was established if the 90% confidence intervals (CIs) of the geometric mean ratio for Day 7 AUC0-24 and Cmax were completely contained within the range of 80% to 125%.|Ratio (%) of Geometric Means|101.6|||||TWO_SIDED|90.0|95.1|108.5|||||Geometric mean ratio (Apremilast 75 mg XL QD / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To assess the exposure between the extended release apremilast formulation, and Reference IR (30 mg reference IR BID) tablet following multiple oral doses, an analysis of variance (ANOVA) model, with sequence, period, and treatment as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Day 7 Cmax.||108.5|95.1|
74100726|NCT02114385|147751024|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.23|||<|0.001|TWO_SIDED|95.0|1.04|1.45|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 6||1.45|1.04|<0.001
74100727|NCT02114385|147751024|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.76|1.04|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 11||1.04|0.76|<0.001
74100728|NCT02114385|147751024|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.89|1.21|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16||1.21|0.89|<0.001
74100729|NCT02114385|147751024|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.12|||<|0.001|TWO_SIDED|95.0|0.91|1.37|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18||1.37|0.91|<0.001
73881699|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.34||0.1273|TWO_SIDED|95.0|-1.2|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||0.15|-1.20|0.1273
74056796|NCT02777554|147665118|EQUIVALENCE|Equivalent exposure of the QD formulation to the BID tablet was established if the 90% CIs of the geometric mean ratio for Day 7 AUC0-24 and Cmax were completely contained within the range of 80% to 125%.|Ratio (%) of Geometric Means|95.3|||||TWO_SIDED|90.0|88.9|102.2|||||Geometric mean ratio (Apremilast 75 mg XL QD / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To assess the exposure between the extended release apremilast formulation, and Reference IR (30 mg reference IR BID) tablet following multiple oral doses, an ANOVA model, with sequence, period, and treatment as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Day 7 AUC0-24.||102.2|88.9|
74056797|NCT02777554|147665119|OTHER||Ratio (%) of Geometric Means|103.9|||||TWO_SIDED|90.0|93.6|115.4|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||115.4|93.6|
74056798|NCT02777554|147665119|OTHER||Ratio (%) of Geometric Means|90.9|||||TWO_SIDED|90.0|81.6|101.3|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||101.3|81.6|
74056799|NCT02777554|147665119|OTHER||Ratio (%) of Geometric Means|115.0|||||TWO_SIDED|90.0|103.3|128.1|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||128.1|103.3|
74056800|NCT02777554|147665119|OTHER||Ratio (%) of Geometric Means|126.5|||||TWO_SIDED|90.0|113.7|140.8|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||140.8|113.7|
74056801|NCT02777554|147665120|OTHER||Ratio (%) of Geometric Means|92.9|||||TWO_SIDED|90.0|81.3|106.2|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||106.2|81.3|
74056802|NCT02777554|147665120|OTHER||Ratio (%) of Geometric Means|86.0|||||TWO_SIDED|90.0|74.9|98.7|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||98.7|74.9|
74100730|NCT02995408|147751076|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.23|TWO_SIDED|95.0|-2.63|0.65||p-value was calculated|t-test, 2 sided|||||0.65|-2.63|.23
74100731|NCT02995408|147751077|SUPERIORITY||Mean Difference (Final Values)|5.78||||0.024|TWO_SIDED|95.0|0.78|10.78||.05 is the threshold for significance|t-test, 2 sided|||We examined between group (3RP treatment versus wait-list) differences in pre-post change scores of resiliency.||10.78|.78|0.024
74056803|NCT02777554|147665120|OTHER||Ratio (%) of Geometric Means|97.3|||||TWO_SIDED|90.0|84.9|111.6|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||111.6|84.9|
74056804|NCT02777554|147665120|OTHER||Ratio (%) of Geometric Means|113.2|||||TWO_SIDED|90.0|98.8|129.7|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||129.7|98.8|
74056805|NCT02777554|147665121|OTHER||Ratio (%) of Geometric Means|92.6|||||TWO_SIDED|90.0|81.1|105.9|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||105.9|81.1|
74100732|NCT02995408|147751078|SUPERIORITY||Mean Difference (Final Values)|7.78||||0.001|TWO_SIDED|95.0|3.45|12.12||p=.05 is the threshold for significance.|t-test, 2 sided|||||12.12|3.45|0.001
74100733|NCT00704132|147751109|SUPERIORITY_OR_OTHER||Difference in Least-Squares Mean|-111.0|||<|0.001||95.0|-158.0|-63.9|||ANCOVA||Sitagliptin minus Placebo|||-63.9|-158.0|<0.001
74100734|NCT03633825|147751121|SUPERIORITY||Risk Ratio (RR)|1.23|||=|0.02|TWO_SIDED|95.0|1.03|1.46|||Chi-squared|||||1.46|1.03|=.02
74100735|NCT03633825|147751122|SUPERIORITY||Risk Ratio (RR)|1.2|||=|0.19|TWO_SIDED|95.0|0.91|1.59|||Chi-squared|||||1.59|0.91|=.19
74100736|NCT03837743|147751144|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.42||0.022|TWO_SIDED||||||Paired t-test|||Difference in Change (week 4)||||0.022
73881700|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.35||0.0046|TWO_SIDED|95.0|-1.69|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.31|-1.69|0.0046
74056806|NCT02777554|147665121|OTHER||Ratio (%) of Geometric Means|86.1|||||TWO_SIDED|90.0|75.0|98.8|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||98.8|75.0|
74056807|NCT02777554|147665121|OTHER||Ratio (%) of Geometric Means|97.5|||||TWO_SIDED|90.0|85.0|111.8|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||111.8|85.0|
74056808|NCT02777554|147665121|OTHER||Ratio (%) of Geometric Means|113.2|||||TWO_SIDED|90.0|98.8|129.7|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||129.7|98.8|
74056809|NCT00066573|147665151|SUPERIORITY|To detect a hazard ratio (HR) of 0.80 between exemestane and anastrozole (ie, an improvement in 5-year EFS from 87.5% to 89.9%, with a two-sided 5% level test and 80% power, 6,840 patients and 630 events were needed for final analysis.|Hazard Ratio (HR)|1.02||||0.85|TWO_SIDED|95.0|0.87|1.18|||Log Rank|||||1.18|0.87|0.85
74056810|NCT00066573|147665152|SUPERIORITY|No power calculation for secondary analysis|Hazard Ratio (HR)|0.93||||0.46|TWO_SIDED|95.0|0.77|1.13|||Log Rank|||||1.13|0.77|0.46
74056811|NCT01241591|147665157|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% lower confidence intervals (LCIs) of the difference for PGA and Psoriasis Area and Severity Index 75 (PASI75) responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA response and PASI75 at Week 12.|Mean Difference|-19.16|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-26.55|-11.76||||||Difference from Etanercept (Active-Etanercept)||-11.76|-26.55|
74056812|NCT01241591|147665157|SUPERIORITY_OR_OTHER||Mean Difference|32.16|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|23.51|40.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the lower bounds of the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.||40.81|23.51|
74056813|NCT01241591|147665157|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|3.64|||TWO_SIDED|95.0|-5.22|9.05||||||Difference from Etanercept (Active-Etanercept)||9.05|-5.22|
74056814|NCT01241591|147665157|SUPERIORITY_OR_OTHER||Mean Difference|53.23|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|44.81|61.65||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.||61.65|44.81|
74056815|NCT01241591|147665158|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA and PASI75 response at Week 12.|Mean Difference|-19.29|STANDARD_ERROR_OF_MEAN|3.81|||TWO_SIDED|95.0|-26.75|-11.83||||||Difference from Etanercept (Active-Etanercept)||-11.83|-26.75|
74056816|NCT01241591|147665158|SUPERIORITY_OR_OTHER||Mean Difference|33.91|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|27.06|40.76||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.||40.76|27.06|
74100737|NCT03837743|147751144|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.8||0.296|TWO_SIDED||||||Paired t-test|||Difference in Change (week 8)||||0.296
74100738|NCT00086281|147751169|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA on ranks|||||||0.009
73881701|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.19|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.80|-2.19|<0.0001
74100739|NCT00086281|147751169|SUPERIORITY_OR_OTHER|||||||0.0244||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.0244
74100740|NCT00086281|147751169|SUPERIORITY_OR_OTHER|||||||0.0119||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.0119
74100741|NCT00086281|147751169|SUPERIORITY_OR_OTHER|||||||0.5055||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.5055
74100742|NCT00086281|147751169|SUPERIORITY_OR_OTHER|||||||0.3132||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.3132
74056817|NCT01241591|147665158|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|4.83|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-2.57|12.23||||||Difference from Etanercept (Active-Etanercept)||12.23|-2.57|
74056818|NCT01241591|147665158|SUPERIORITY_OR_OTHER||Mean Difference|58.03|STANDARD_ERROR_OF_MEAN|3.46|||TWO_SIDED|95.0|51.25|64.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.||64.81|51.25|
74056819|NCT01945034|147665203|SUPERIORITY_OR_OTHER||LS Mean Difference|23.0||||0.19|TWO_SIDED|95.0|-11.49|57.56||p-value \<=0.05 for treatment effects|ANOVA|||The analysis of variance (ANOVA) model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||57.56|-11.49|0.190
74056820|NCT01945034|147665203|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.633|TWO_SIDED|95.0|-24.2|39.7||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||39.70|-24.20|0.633
74056821|NCT01945034|147665203|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3||||0.436|TWO_SIDED|95.0|-53.87|23.3||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms.||23.30|-53.87|0.436
74056822|NCT01945034|147665204|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|4.8||||0.426|TWO_SIDED|95.0|-6.98|16.49||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating (BLPSR), pooled site blocks, and baseline pain intensity on weight bearing (BLPIWB) terms. 95% CI not includes 0 for treatment effect. Upper limit of 95% CI\< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.||16.49|-6.98|0.426
74056823|NCT01945034|147665204|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.85|TWO_SIDED|95.0|-11.9|9.82||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.||9.82|-11.90|0.850
74056824|NCT01945034|147665204|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8||||0.385|TWO_SIDED|95.0|-18.91|7.32||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. A comparison was eligible for being declared significant only if preceding comparison was significant.||7.32|-18.91|0.385
74100743|NCT02027428|147751179|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.3486|TWO_SIDED|95.0|0.61|1.19||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.19|0.61|0.3486
74056825|NCT01945034|147665205|SUPERIORITY_OR_OTHER||LS Mean Difference|10.0||||0.072|TWO_SIDED|95.0|-0.92|20.91||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||20.91|-0.92|0.072
74056826|NCT01945034|147665205|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.296|TWO_SIDED|95.0|-15.4|4.7||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.70|-15.40|0.296
74056827|NCT01945034|147665205|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3||||0.014|TWO_SIDED|95.0|-27.53|-3.16||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms.||-3.16|-27.53|0.014
74056828|NCT01945034|147665206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.305|TWO_SIDED|95.0|-0.1|0.3||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo||0.30|-0.10|0.305
74056829|NCT01945034|147665206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.261|TWO_SIDED|95.0|-0.08|0.29||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.29|-0.08|0.261
74056830|NCT01945034|147665206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.996|TWO_SIDED|95.0|-0.22|0.22||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.||0.22|-0.22|0.996
74056831|NCT01945034|147665206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.21|TWO_SIDED|95.0|-0.08|0.36||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.36|-0.08|0.210
74056832|NCT01945034|147665206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.556|TWO_SIDED|95.0|-0.14|0.27||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.27|-0.14|0.556
74056833|NCT01945034|147665206|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.534|TWO_SIDED|95.0|-0.33|0.17||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.||0.17|-0.33|0.534
74056834|NCT01945034|147665207|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.354|TWO_SIDED|95.0|-0.27|0.1||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.10|-0.27|0.354
74056835|NCT01945034|147665207|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.237|TWO_SIDED|95.0|-0.28|0.07||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.07|-0.28|0.237
74056836|NCT01945034|147665207|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.871|TWO_SIDED|95.0|-0.23|0.19||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.||0.19|-0.23|0.871
74056837|NCT01945034|147665207|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.05|TWO_SIDED|95.0|-0.43|0.0||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-0.00|-0.43|0.050
74056838|NCT01945034|147665207|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.64|TWO_SIDED|95.0|-0.25|0.15||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.15|-0.25|0.640
74056839|NCT01945034|147665207|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.18|TWO_SIDED|95.0|-0.08|0.41||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.||0.41|-0.08|0.180
73881702|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.19|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.78|-2.19|<0.0001
74056840|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.771|TWO_SIDED|95.0|-0.38|0.51|||ANOVA|||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.51|-0.38|0.771
74056841|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.022|TWO_SIDED|95.0|-0.88|-0.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-0.07|-0.88|0.022
74056842|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.032|TWO_SIDED|95.0|-1.03|-0.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.05|-1.03|0.032
74056843|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.72|TWO_SIDED|95.0|-0.38|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.55|-0.38|0.720
73881703|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0333|TWO_SIDED|95.0|-1.45|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.06|-1.45|0.0333
73881704|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0423|TWO_SIDED|95.0|-1.39|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.02|-1.39|0.0423
73881705|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0208|TWO_SIDED|95.0|-1.49|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.12|-1.49|0.0208
74056844|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.194|TWO_SIDED|95.0|-0.71|0.15|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.15|-0.71|0.194
74056845|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.163|TWO_SIDED|95.0|-0.89|0.15|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.15|-0.89|0.163
74056846|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.644|TWO_SIDED|95.0|-0.4|0.64|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.64|-0.40|0.644
74056847|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.129|TWO_SIDED|95.0|-0.85|0.11|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.11|-0.85|0.129
74056848|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.096|TWO_SIDED|95.0|-1.07|0.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.09|-1.07|0.096
74056849|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.905|TWO_SIDED|95.0|-0.5|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.57|-0.50|0.905
73881706|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3435|TWO_SIDED|95.0|-0.55|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.19|-0.55|0.3435
73881707|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0021|TWO_SIDED|95.0|-0.98|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||-0.22|-0.98|0.0021
73881708|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0408|TWO_SIDED|95.0|-0.79|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||-0.02|-0.79|0.0408
74056850|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.279|TWO_SIDED|95.0|-0.77|0.22|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.77|0.279
74056851|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.315|TWO_SIDED|95.0|-0.9|0.29|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.29|-0.90|0.315
74056852|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.203|TWO_SIDED|95.0|-0.19|0.91|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.91|-0.19|0.203
74056853|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.207|TWO_SIDED|95.0|-0.83|0.18|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.18|-0.83|0.207
74056854|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.03|TWO_SIDED|95.0|-1.3|-0.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.07|-1.30|0.030
74056855|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.372|TWO_SIDED|95.0|-0.32|0.84|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.84|-0.32|0.372
74056856|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.532|TWO_SIDED|95.0|-0.7|0.36|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.36|-0.70|0.532
74056857|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.189|TWO_SIDED|95.0|-1.08|0.21|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.21|-1.08|0.189
74056858|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.264|TWO_SIDED|95.0|-0.24|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.24|0.264
74056859|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.81|0.22|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1:The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.81|0.260
74056860|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.054|TWO_SIDED|95.0|-1.23|0.01|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.01|-1.23|0.054
74056861|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.456|TWO_SIDED|95.0|-0.37|0.81|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.81|-0.37|0.456
73881709|NCT03192176|147297635|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0911|TWO_SIDED|95.0|-0.73|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.05|-0.73|0.0911
74056862|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.639|TWO_SIDED|95.0|-0.42|0.68|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.68|-0.42|0.639
74056863|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.78|TWO_SIDED|95.0|-0.75|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.57|-0.75|0.780
74056864|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.071|TWO_SIDED|95.0|-0.04|1.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.07|-0.04|0.071
74056865|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.468|TWO_SIDED|95.0|-0.7|0.32|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.32|-0.70|0.468
74056866|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.027|TWO_SIDED|95.0|-1.33|-0.08|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.08|-1.33|0.027
74056867|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.107|TWO_SIDED|95.0|-0.11|1.09|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.11|0.107
74056868|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.947|TWO_SIDED|95.0|-0.57|0.53|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.53|-0.57|0.947
74056869|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.134|TWO_SIDED|95.0|-1.18|0.16|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.16|-1.18|0.134
74056870|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.017|TWO_SIDED|95.0|0.12|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.12|0.017
74056871|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.715|TWO_SIDED|95.0|-0.6|0.41|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.41|-0.60|0.715
74056872|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.015|TWO_SIDED|95.0|-1.39|-0.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.15|-1.39|0.015
74056873|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.027|TWO_SIDED|95.0|0.07|1.23|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.07|0.027
74056874|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.66|TWO_SIDED|95.0|-0.42|0.65|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.65|-0.42|0.660
74056875|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.107|TWO_SIDED|95.0|-1.18|0.11|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.11|-1.18|0.107
74056876|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.02|TWO_SIDED|95.0|0.1|1.13|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|0.10|0.020
74056877|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.749|TWO_SIDED|95.0|-0.55|0.4|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.40|-0.55|0.749
74056878|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.019|TWO_SIDED|95.0|-1.27|-0.12|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.12|-1.27|0.019
74056879|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.163|TWO_SIDED|95.0|-0.16|0.96|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.96|-0.16|0.163
74056880|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.727|TWO_SIDED|95.0|-0.43|0.61|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.61|-0.43|0.727
74056881|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.336|TWO_SIDED|95.0|-0.94|0.32|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.32|-0.94|0.336
74056882|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.174|TWO_SIDED|95.0|-0.16|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.16|0.174
74100744|NCT02027428|147751180|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0365|TWO_SIDED|95.0|0.47|0.98||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||0.98|0.47|0.0365
74056883|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.277|TWO_SIDED|95.0|-0.73|0.21|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.21|-0.73|0.277
74056884|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.035|TWO_SIDED|95.0|-1.19|-0.04|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.04|-1.19|0.035
74056885|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.858|TWO_SIDED|95.0|-0.5|0.6|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.60|-0.50|0.858
73881710|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7891|TWO_SIDED|95.0|-0.44|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.33|-0.44|0.7891
74056886|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.724|TWO_SIDED|95.0|-0.6|0.42|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.42|-0.60|0.724
74100745|NCT02027428|147751181|SUPERIORITY||Overall response rate ratio|1.2||||0.087|TWO_SIDED|95.0|0.948|1.519||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.|Cochran-Mantel-Haenszel||response ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. The rate ratio and its 95% CI were based on the non-stratified analysis.||1.519|0.948|0.0870
74056887|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.651|TWO_SIDED|95.0|-0.76|0.48|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.48|-0.76|0.651
74056888|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.059|TWO_SIDED|95.0|-0.02|1.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.05|-0.02|0.059
74056889|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.766|TWO_SIDED|95.0|-0.57|0.42|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.42|-0.57|0.766
74056890|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.053|TWO_SIDED|95.0|-1.19|0.01|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.01|-1.19|0.053
74056891|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.212|TWO_SIDED|95.0|-0.21|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.21|0.212
74056892|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.911|TWO_SIDED|95.0|-0.49|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.55|-0.49|0.911
74056893|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.305|TWO_SIDED|95.0|-0.96|0.3|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.30|-0.96|0.305
74056894|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.075|TWO_SIDED|95.0|-0.05|1.02|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.05|0.075
73881711|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9973|TWO_SIDED|95.0|-0.38|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.38|-0.38|0.9973
73888187|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9||||0.0229|TWO_SIDED|95.0|0.8|11.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.1|0.8|0.0229
74056895|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.684|TWO_SIDED|95.0|-0.39|0.6|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.60|-0.39|0.684
74056896|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.208|TWO_SIDED|95.0|-0.98|0.21|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.21|-0.98|0.208
74056897|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.304|TWO_SIDED|95.0|-0.27|0.85|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.85|-0.27|0.304
74056898|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.356|TWO_SIDED|95.0|-0.27|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.76|-0.27|0.356
74056899|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.876|TWO_SIDED|95.0|-0.67|0.58|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.58|-0.67|0.876
74056900|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.02|TWO_SIDED|95.0|0.1|1.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.15|0.10|0.020
74056901|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.94|TWO_SIDED|95.0|-0.5|0.47|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.47|-0.50|0.940
74056902|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.032|TWO_SIDED|95.0|-1.23|-0.06|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.06|-1.23|0.032
74100746|NCT02027428|147751182|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.4164|TWO_SIDED|95.0|0.62|1.22||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.22|0.62|0.4164
74100747|NCT02027428|147751183|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0381|TWO_SIDED|95.0|0.47|0.98||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||0.98|0.47|0.0381
74100748|NCT02027428|147751184|SUPERIORITY||Overall response rate ratio|3.15||||0.0978|TWO_SIDED|95.0|0.733|13.574||5% level of significance.|Cochran-Mantel-Haenszel||Response rate ratio: nab-paclitaxel + BSC / BSC Alone|||13.574|0.733|0.0978
74100749|NCT02027428|147751185|SUPERIORITY||disease control rate ratio|0.99|||||TWO_SIDED|95.0|0.978|1.007|||||Disease control rate ratio: nab-paclitaxel + BSC / BSC Alone|The rate ratio and its 95% confidence interval are based on non-stratified analysis.||1.007|0.978|
74100750|NCT02027428|147751187|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.59|1.47|||||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|Hazard ratio was based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.47|0.59|
74100751|NCT01130597|147751190|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.5|||||TWO_SIDED|95.0|80.4|96.4|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval|||96.4|80.4|
74100752|NCT01130597|147751195|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|84.1|||||TWO_SIDED|95.0|72.7|92.1|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval|||92.1|72.7|
74100753|NCT04873934|147751209|SUPERIORITY||LS mean difference|-46.9|||<|0.001|TWO_SIDED|97.5|-55.4|-38.5|||Mixed Models Analysis|||||-38.5|-55.4|< 0.001
74056903|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.206|TWO_SIDED|95.0|-0.21|0.95|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.95|-0.21|0.206
74056904|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.31|TWO_SIDED|95.0|-0.26|0.81|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.81|-0.26|0.310
74100754|NCT04873934|147751210|SUPERIORITY||Odds Ratio (OR)|5.42|||<|0.001|TWO_SIDED|97.5|3.29|8.91|||Regression, Logistic|||||8.91|3.29|< 0.001
74100755|NCT04873934|147751211|SUPERIORITY||LS mean difference|-42.0|||<|0.001|TWO_SIDED|95.0|-47.3|-36.7|||Mixed Models Analysis|||Day 90||-36.7|-47.3|< 0.001
74100756|NCT04873934|147751211|SUPERIORITY||LS mean difference|-30.8|||<|0.001|TWO_SIDED|95.0|-37.4|-24.3|||Mixed Models Analysis|||Day 270||-24.3|-37.4|< 0.001
74100757|NCT04873934|147751211|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.5|-31.0|||Mixed Models Analysis|||Day 330||-31.0|-44.5|< 0.001
74100758|NCT04873934|147751212|SUPERIORITY||LS mean difference|-46.7|||<|0.001|TWO_SIDED|95.0|-52.7|-40.8|||ANCOVA|||||-40.8|-52.7|< 0.001
74100759|NCT04873934|147751213|SUPERIORITY||LS mean difference|-37.3|||<|0.001|TWO_SIDED|95.0|-42.4|-32.2|||ANCOVA|||||-32.2|-42.4|< 0.001
74100760|NCT04873934|147751214|SUPERIORITY||Odds Ratio (OR)|11.87|||<|0.001|TWO_SIDED|95.0|6.33|22.25|||Regression, Logistic|||||22.25|6.33|< 0.001
74100761|NCT04873934|147751215|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.001|TWO_SIDED|95.0|1.92|9.99|||Regression, Logistic|||Achieving LDL-C \< 100 mg/dL||9.99|1.92|< 0.001
74100762|NCT04873934|147751215|SUPERIORITY||Odds Ratio (OR)|8.24|||<|0.001|TWO_SIDED|95.0|4.97|13.65|||Regression, Logistic|||Achieving LDL-C \< 55 mg/dL||13.65|4.97|< 0.001
74100763|NCT04873934|147751216|SUPERIORITY||LS mean difference|-37.5|||<|0.001|TWO_SIDED|95.0|-44.8|-30.3|||Mixed Models Analysis|||Apolipoprotein B||-30.3|-44.8|< 0.001
73881712|NCT03192176|147297635|SUPERIORITY||-0.1|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.6377|TWO_SIDED|95.0|-0.47|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.29|-0.47|0.6377
74056905|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.771|TWO_SIDED|95.0|-0.74|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.55|-0.74|0.771
74056906|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean difference|0.7||||0.016|TWO_SIDED|95.0|0.13|1.24|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.24|0.13|0.016
74056907|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.905|TWO_SIDED|95.0|-0.48|0.54|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.54|-0.48|0.905
74056908|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.039|TWO_SIDED|95.0|-1.28|-0.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.03|-1.28|0.039
74056909|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.276|TWO_SIDED|95.0|-0.27|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.27|0.276
74056910|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.343|TWO_SIDED|95.0|-0.29|0.82|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.82|-0.29|0.343
74056911|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.849|TWO_SIDED|95.0|-0.73|0.6|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.60|-0.73|0.849
74056912|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.009|TWO_SIDED|95.0|0.19|1.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.29|0.19|0.009
74100764|NCT04873934|147751216|SUPERIORITY||LS mean difference|-6.4||||0.188|TWO_SIDED|95.0|-16.0|3.1|||Mixed Models Analysis|||VLDL Cholesterol||3.1|-16.0|0.188
74100765|NCT04873934|147751216|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.0|-31.4|||Mixed Models Analysis|||Non-HDL Cholesterol||-31.4|-44.0|< 0.001
73881713|NCT03192176|147297635|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.61||0.0862|TWO_SIDED|95.0|-5.95|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.40|-5.95|0.0862
74056913|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.763|TWO_SIDED|95.0|-0.58|0.43|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.43|-0.58|0.763
74056914|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.01|TWO_SIDED|95.0|-1.43|-0.2|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.20|-1.43|0.010
74056915|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.105|TWO_SIDED|95.0|-0.1|1.09|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.10|0.105
74056916|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.533|TWO_SIDED|95.0|-0.38|0.73|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.38|0.533
74100766|NCT04873934|147751216|SUPERIORITY||LS mean difference|-25.5|||<|0.001|TWO_SIDED|95.0|-30.2|-20.7|||Mixed Models Analysis|||Total Cholesterol||-20.7|-30.2|< 0.001
74100767|NCT04873934|147751216|SUPERIORITY||LS mean difference|-16.4||||0.145|TWO_SIDED|95.0|-38.4|5.7|||Mixed Models Analysis|||Lipoprotein(a)||5.7|-38.4|0.145
74100768|NCT04873934|147751216|SUPERIORITY||LS mean difference|3.5||||0.141|TWO_SIDED|95.0|-1.2|8.1|||Mixed Models Analysis|||HDL Cholesterol||8.1|-1.2|0.141
74100769|NCT04873934|147751216|SUPERIORITY||LS mean difference|-5.0||||0.339|TWO_SIDED|95.0|-15.2|5.3|||Mixed Models Analysis|||Triglycerides||5.3|-15.2|0.339
74056917|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.348|TWO_SIDED|95.0|-0.99|0.35|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.35|-0.99|0.348
74056918|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.016|TWO_SIDED|95.0|0.13|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.13|0.016
74056919|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.483|TWO_SIDED|95.0|-0.69|0.33|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.33|-0.69|0.483
74056920|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.006|TWO_SIDED|95.0|-1.47|-0.25|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.25|-1.47|0.006
74056921|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.177|TWO_SIDED|95.0|-0.19|1.0|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.00|-0.19|0.177
74056922|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.586|TWO_SIDED|95.0|-0.4|0.7|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.70|-0.40|0.586
74056923|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.448|TWO_SIDED|95.0|-0.92|0.41|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.41|-0.92|0.448
74056924|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.043|TWO_SIDED|95.0|0.02|1.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|0.02|0.043
74056925|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.688|TWO_SIDED|95.0|-0.59|0.39|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.39|-0.59|0.688
74100770|NCT04873934|147751217|SUPERIORITY||LS mean difference|-28.4|||<|0.001|TWO_SIDED|95.0|-33.0|-23.9|||Mixed Models Analysis|||Apolipoprotein B||-23.9|-33.0|< 0.001
74100771|NCT04873934|147751217|SUPERIORITY||LS mean difference|-2.1||||0.078|TWO_SIDED|95.0|-4.5|0.2|||Mixed Models Analysis|||VLDL Cholesterol||0.2|-4.5|0.078
74100772|NCT04873934|147751217|SUPERIORITY||LS mean difference|-40.1|||<|0.001|TWO_SIDED|95.0|-47.5|-32.8|||Mixed Models Analysis|||Non-HDL Cholesterol||-32.8|-47.5|< 0.001
74100773|NCT04873934|147751217|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-45.3|-30.2|||Mixed Models Analysis|||Total Cholesterol||-30.2|-45.3|< 0.001
74056926|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.032|TWO_SIDED|95.0|-1.25|-0.06|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.06|-1.25|0.032
74056927|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.179|TWO_SIDED|95.0|-0.19|0.99|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.99|-0.19|0.179
74056928|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.609|TWO_SIDED|95.0|-0.4|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.69|-0.40|0.609
74056929|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.435|TWO_SIDED|95.0|-0.92|0.4|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.40|-0.92|0.435
74056930|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.023|TWO_SIDED|95.0|0.1|1.26|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.26|0.10|0.023
74100774|NCT04873934|147751217|SUPERIORITY||LS mean difference|1.9||||0.065|TWO_SIDED|95.0|-0.1|3.8|||Mixed Models Analysis|||HDL Cholesterol||3.8|-0.1|0.065
74100775|NCT04873934|147751217|SUPERIORITY||LS mean difference|-8.7||||0.222|TWO_SIDED|95.0|-22.8|5.3|||Mixed Models Analysis|||Triglycerides||5.3|-22.8|0.222
74100776|NCT04873934|147751218|SUPERIORITY||LS mean difference|-14.0||||0.005|TWO_SIDED|95.0|-23.8|-4.2|||Mixed Models Analysis|||Lipoprotein(a)||-4.2|-23.8|0.005
74100777|NCT04873934|147751219|SUPERIORITY||Odds Ratio (OR)|0.43||||0.031|TWO_SIDED|95.0|0.2|0.93|||proportional odds model|||||0.93|0.20|0.031
74100778|NCT04873934|147751220|SUPERIORITY||LS mean difference|-0.039||||0.043|TWO_SIDED|95.0|-0.077|-0.001|||ANCOVA|||||-0.001|-0.077|0.043
73881714|NCT03192176|147297635|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.65||0.1305|TWO_SIDED|95.0|-5.74|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.74|-5.74|0.1305
73881715|NCT03192176|147297635|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.68||0.0707|TWO_SIDED|95.0|-6.34|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.26|-6.34|0.0707
74056931|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.987|TWO_SIDED|95.0|-0.54|0.53|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.53|-0.54|0.987
74056932|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.04|TWO_SIDED|95.0|-1.33|-0.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.03|-1.33|0.040
74056933|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.319|TWO_SIDED|95.0|-0.31|0.94|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.31|0.319
74056934|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.712|TWO_SIDED|95.0|-0.47|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.69|-0.47|0.712
74100779|NCT04873934|147751221|SUPERIORITY||Odds Ratio (OR)|0.76||||0.346|TWO_SIDED|95.0|0.43|1.35|||Regression, Logistic|||||1.35|0.43|0.346
74100780|NCT02766283|147751299|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
74056935|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.557|TWO_SIDED|95.0|-0.91|0.49|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.49|-0.91|0.557
74100781|NCT02766283|147751300|SUPERIORITY_OR_OTHER|||||||0.022|||||||Chi-squared|||||||0.022
74100782|NCT00754546|147751307|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||"ANOVA was used to examine the interaction between mode of exercise and treatment effect.~Twenty patients were considered adequate to provide a power of 85% with an alpha of 0.05."||||< 0.05
74100783|NCT00754546|147751307|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||Comparing arformoterol with placebo with treadmill exercise||||0.024
73881716|NCT03192176|147297635|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.68||0.1232|TWO_SIDED|95.0|-5.92|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.71|-5.92|0.1232
74056936|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.015|TWO_SIDED|95.0|0.14|1.28|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.28|0.14|0.015
74056937|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.326|TWO_SIDED|95.0|-0.26|0.79|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.79|-0.26|0.326
74100784|NCT00754546|147751307|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||Arformoterol versus normal saline with cycle exercise||||0.038
74100785|NCT02126826|147751332|SUPERIORITY_OR_OTHER||Slope|0.7865|||||TWO_SIDED|90.0|0.6193|0.9537|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||0.9537|0.6193|
74100786|NCT02126826|147751332|SUPERIORITY_OR_OTHER||Slope|1.0171|||||TWO_SIDED|90.0|0.8378|1.1964|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.1964|0.8378|
74100787|NCT02126826|147751334|SUPERIORITY_OR_OTHER||Slope|0.9511|||||TWO_SIDED|90.0|0.7654|1.1367|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||1.1367|0.7654|
74100788|NCT02126826|147751334|SUPERIORITY_OR_OTHER||Slope|1.0834|||||TWO_SIDED|90.0|0.8655|1.3013|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.3013|0.8655|
74100789|NCT02126826|147751336|SUPERIORITY_OR_OTHER||Slope|0.7832|||||TWO_SIDED|90.0|0.6235|0.9428|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||0.9428|0.6235|
74100790|NCT02126826|147751336|SUPERIORITY_OR_OTHER||Slope|1.0365|||||TWO_SIDED|90.0|0.8593|1.2137|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.2137|0.8593|
74100791|NCT02126826|147751338|SUPERIORITY_OR_OTHER||Slope|0.9433|||||TWO_SIDED|90.0|0.7744|1.1122|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||1.1122|0.7744|
74100792|NCT02126826|147751338|SUPERIORITY_OR_OTHER||Slope|1.081|||||TWO_SIDED|90.0|0.8583|1.3037|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.3037|0.8583|
74100793|NCT03888066|147751339|SUPERIORITY||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.015|<|0.001|TWO_SIDED|95.0|-0.128|-0.067|||Mixed model for repeated measures (MMRM)|||Difference in adjusted mean changes (SE)||-0.067|-0.128|< 0.001
74100794|NCT03888066|147751340|SUPERIORITY||Hazard Ratio (HR)|0.63|||=|0.006|TWO_SIDED|95.0|0.45|0.87||Threshold for statistical significance = 0.05|Regression, Cox|||"Hazard Ratio patiromer vs placebo.~The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.~HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.87|0.45|= 0.006
74100795|NCT03888066|147751341|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.006|TWO_SIDED|95.0|0.45|0.87||Threshold for statistical significance = 0.05|Regression, Cox|||"Hazard Ratio patiromer vs placebo.~The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.~HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.87|0.45|= 0.006
74100796|NCT03888066|147751342|SUPERIORITY||Annualized event rate ratio|0.658|||<|0.001|TWO_SIDED|95.0|0.534|0.81|||Negative binomial model adjusted for cov|||"NBMAC Annualized event RR patiromer vs placebo.~NBMAC adjusted for geographical region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR. Rate ratio less than 1 favors patiromer.~NBMAC=Negative binomial model adjusted for covariates; RR=Rate Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.81|0.534|< 0.001
74100797|NCT03888066|147751343|SUPERIORITY||Win Ratio|1.526|||<|0.001|TWO_SIDED|95.0|1.231|1.906|||Win Ratio|||"Win ratio for composite.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers."||1.906|1.231|<0.001
74100798|NCT03888066|147751343|SUPERIORITY||Win Ratio|0.914|||=|0.744|TWO_SIDED|95.0|0.526|1.578|||Win Ratio|||"Win ratio CV death and hospitalization.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer."||1.578|0.526|= 0.744
74100799|NCT03888066|147751344|SUPERIORITY||Win Ratio|1.248|||=|0.048|TWO_SIDED|95.0|1.003|1.564|||Win Ratio|||"Win ratio for composite.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer."||1.564|1.003|= 0.048
74100800|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.001||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Matrilysin (P09237) was analyzed.||||= 0.001
74100801|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.002||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of von Willebrand factor (P04275) was analyzed.||||= 0.002
74019809|NCT01360645|147591704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0001|TWO_SIDED|95.0|-0.54|-0.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-0.18|-0.54|0.0001
74100802|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.044||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 4 (O95388) was analyzed.||||= 0.044
74019810|NCT01360645|147591704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0004|TWO_SIDED|95.0|-0.52|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14.||-0.15|-0.52|0.0004
74056938|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.167|TWO_SIDED|95.0|-1.08|0.19|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.19|-1.08|0.167
74056939|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.35|TWO_SIDED|95.0|-0.33|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.33|0.350
74056940|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.235|TWO_SIDED|95.0|-0.23|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.23|0.235
74100803|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.044||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta-1 proprotein (P01137) was analyzed.||||= 0.044
74100804|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.127||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta receptor type 3 (Q03167) was analyzed.||||= 0.127
74100805|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.21||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of IL-15 receptor subunit alpha (Q13261) was analyzed.||||= 0.210
74100806|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.215||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Metalloproteinase inhibitor 1 (P01033) was analyzed.||||= 0.215
74056941|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.881|TWO_SIDED|95.0|-0.65|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.76|-0.65|0.881
74056942|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.036|TWO_SIDED|95.0|0.04|1.16|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.16|0.04|0.036
74100807|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.215||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Pappalysin-1 (Q13219) was analyzed.||||= 0.215
74100808|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.745||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Proto-oncogene c-Src (P12931) was analyzed.||||= 0.745
74100809|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Protein AMBP (P02760) was analyzed.||||= 0.762
74100810|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Uromodulin (P07911) was analyzed.||||= 0.762
74056943|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.656|TWO_SIDED|95.0|-0.4|0.63|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.63|-0.40|0.656
74056944|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.13|TWO_SIDED|95.0|-1.11|0.14|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.14|-1.11|0.130
73881717|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.66||0.253|TWO_SIDED|95.0|-5.18|1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||1.37|-5.18|0.2530
74100811|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Aminopeptidase N (P15144) was analyzed.||||= 0.762
74100812|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TNFRSF1A (P19438) was analyzed.||||= 0.762
74100813|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Plasminogen activator inhibitor 1 (P05121) was analyzed.||||= 0.917
74100814|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 2 (P29279) was analyzed.||||= 0.917
74100815|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of uPAR (Q03405) was analyzed.||||= 0.917
74056945|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.304|TWO_SIDED|95.0|-0.3|0.95|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.95|-0.30|0.304
74056946|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.491|TWO_SIDED|95.0|-0.37|0.78|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.78|-0.37|0.491
74056947|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.726|TWO_SIDED|95.0|-0.82|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.57|-0.82|0.726
74056948|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.029|TWO_SIDED|95.0|0.07|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.07|0.029
74056949|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.585|TWO_SIDED|95.0|-0.39|0.68|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.68|-0.39|0.585
74056950|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.131|TWO_SIDED|95.0|-1.15|0.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.15|-1.15|0.131
73888188|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2||||0.2168|TWO_SIDED|95.0|-1.9|8.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.3|-1.9|0.2168
74056951|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.215|TWO_SIDED|95.0|-0.24|1.04|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.04|-0.24|0.215
74056952|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.244|TWO_SIDED|95.0|-0.24|0.94|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.24|0.244
74056953|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.885|TWO_SIDED|95.0|-0.76|0.66|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.66|-0.76|0.885
74056954|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.067|TWO_SIDED|95.0|-0.04|1.13|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|-0.04|0.067
74056955|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.5|TWO_SIDED|95.0|-0.35|0.73|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.35|0.500
74056956|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.276|TWO_SIDED|95.0|-1.02|0.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.29|-1.02|0.276
74056957|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.413|TWO_SIDED|95.0|-0.38|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.38|0.413
74056958|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.448|TWO_SIDED|95.0|-0.37|0.83|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.83|-0.37|0.448
74056959|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.917|TWO_SIDED|95.0|-0.76|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.69|-0.76|0.917
74100816|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 14 (Q16627) was analyzed.||||= 0.917
74100817|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 16 (O15467) was analyzed.||||= 0.979
74056960|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.132|TWO_SIDED|95.0|-0.13|1.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.03|-0.13|0.132
74056961|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.505|TWO_SIDED|95.0|-0.35|0.72|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.72|-0.35|0.505
74056962|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.422|TWO_SIDED|95.0|-0.92|0.38|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.38|-0.92|0.422
74056963|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.747|TWO_SIDED|95.0|-0.54|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.76|-0.54|0.747
74056964|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.386|TWO_SIDED|95.0|-0.34|0.87|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.34|0.386
74056965|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.668|TWO_SIDED|95.0|-0.57|0.89|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.89|-0.57|0.668
74056966|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.099|TWO_SIDED|95.0|-0.09|1.08|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.08|-0.09|0.099
74056967|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.365|TWO_SIDED|95.0|-0.29|0.79|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.79|-0.29|0.365
74056968|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.463|TWO_SIDED|95.0|-0.9|0.41|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.41|-0.90|0.463
74056969|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.845|TWO_SIDED|95.0|-0.6|0.73|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.60|0.845
74056970|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.199|TWO_SIDED|95.0|-0.21|1.02|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.21|0.199
74056971|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.375|TWO_SIDED|95.0|-0.41|1.08|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.08|-0.41|0.375
74056972|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.028|TWO_SIDED|95.0|0.07|1.27|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.27|0.07|0.028
74056973|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.188|TWO_SIDED|95.0|-0.18|0.92|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.18|0.188
74056974|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.375|TWO_SIDED|95.0|-0.97|0.37|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.37|-0.97|0.375
74056975|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.552|TWO_SIDED|95.0|-0.47|0.89|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.89|-0.47|0.552
74056976|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.126|TWO_SIDED|95.0|-0.14|1.12|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.12|-0.14|0.126
74056977|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.46|TWO_SIDED|95.0|-0.47|1.05|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.05|-0.47|0.460
74056978|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.095|TWO_SIDED|95.0|-0.09|1.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.09|0.095
74056979|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.146|TWO_SIDED|95.0|-0.14|0.94|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.14|0.146
74056980|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.769|TWO_SIDED|95.0|-0.75|0.56|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.56|-0.75|0.769
74056981|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.405|TWO_SIDED|95.0|-0.39|0.96|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.96|-0.39|0.405
74056982|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.073|TWO_SIDED|95.0|-0.05|1.2|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.20|-0.05|0.073
74056983|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.458|TWO_SIDED|95.0|-0.47|1.04|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.04|-0.47|0.458
74056984|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.009|TWO_SIDED|95.0|0.2|1.39|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.39|0.20|0.009
74056985|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.209|TWO_SIDED|95.0|-0.2|0.9|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.90|-0.20|0.209
74056986|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.193|TWO_SIDED|95.0|-1.11|0.22|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.22|-1.11|0.193
74056987|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.149|TWO_SIDED|95.0|-0.18|1.18|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.18|-0.18|0.149
74056988|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.186|TWO_SIDED|95.0|-0.21|1.06|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.06|-0.21|0.186
74056989|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.845|TWO_SIDED|95.0|-0.84|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.69|-0.84|0.845
74056990|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.067|TWO_SIDED|95.0|-0.04|1.14|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.14|-0.04|0.067
74056991|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.242|TWO_SIDED|95.0|-0.22|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.22|0.242
74056992|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.498|TWO_SIDED|95.0|-0.88|0.43|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.43|-0.88|0.498
74056993|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.33|TWO_SIDED|95.0|-0.34|1.02|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.34|0.330
74056994|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.124|TWO_SIDED|95.0|-0.14|1.13|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|-0.14|0.124
74056995|NCT01945034|147665208|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.687|TWO_SIDED|95.0|-0.61|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.92|-0.61|0.687
74056996|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.166|TWO_SIDED|95.0|-0.85|4.95|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.95|-0.85|0.166
74056997|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7||||0.199|TWO_SIDED|95.0|-4.42|0.93|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-4.42|0.199
74056998|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8||||0.022|TWO_SIDED|95.0|-7.04|-0.56|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.56|-7.04|0.022
74056999|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.26|TWO_SIDED|95.0|-1.3|4.79|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.79|-1.30|0.260
74057000|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.729|TWO_SIDED|95.0|-3.31|2.32|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||2.32|-3.31|0.729
74100818|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Collagen alpha-1(I) chain (P02452) was analyzed.||||= 0.979
74100819|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Decorin (P07585) was analyzed.||||= 0.979
74100820|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 2 (P13500) was analyzed.||||= 0.979
74057001|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2||||0.196|TWO_SIDED|95.0|-5.64|1.16|||ANOVA|||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||1.16|-5.64|0.196
74057002|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|24.9||||0.03|TWO_SIDED|95.0|2.49|47.28|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||47.28|2.49|0.030
74057003|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.2||||0.018|TWO_SIDED|95.0|-55.24|-5.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-5.23|-55.24|0.018
74057004|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.611|TWO_SIDED|95.0|-25.98|15.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||15.29|-25.98|0.611
74057005|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|13.8||||0.251|TWO_SIDED|95.0|-9.8|37.36|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||37.36|-9.80|0.251
74057006|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|4.4||||0.689|TWO_SIDED|95.0|-17.37|26.26|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||26.26|-17.37|0.689
74057007|NCT01945034|147665209|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.3||||0.486|TWO_SIDED|95.0|-35.69|17.01|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||17.01|-35.69|0.486
74057008|NCT01945034|147665210|SUPERIORITY_OR_OTHER||LS Mean Difference|38.5||||0.021|TWO_SIDED|95.0|5.9|71.18|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||71.18|5.90|0.021
74100821|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Matrix metalloproteinase-9 (P14780) was analyzed.||||= 0.979
74100822|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of E-selectin (P16581) was analyzed.||||= 0.979
74100823|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Thrombospondin-2 (P35442) was analyzed.||||= 0.979
74100824|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of RARRES2 (Q99969) was analyzed.||||= 0.979
74057009|NCT01945034|147665210|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9||||0.603|TWO_SIDED|95.0|-38.02|22.12|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||22.12|-38.02|0.603
74057010|NCT01945034|147665210|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.5||||0.013|TWO_SIDED|95.0|-82.93|-10.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-10.05|-82.93|0.013
74057011|NCT01945034|147665211|SUPERIORITY_OR_OTHER||LS Mean Difference|87.7||||0.021|TWO_SIDED|95.0|13.48|161.85|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||161.85|13.48|0.021
74057012|NCT01945034|147665211|SUPERIORITY_OR_OTHER||LS Mean Difference|11.8||||0.735|TWO_SIDED|95.0|-56.59|80.11|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||80.11|-56.59|0.735
74057013|NCT01945034|147665211|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.9||||0.072|TWO_SIDED|95.0|-158.73|6.93|||ANOVA|||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||6.93|-158.73|0.072
74057014|NCT01945034|147665211|SUPERIORITY_OR_OTHER||LS Mean Difference|46.0||||0.261|TWO_SIDED|95.0|-34.43|126.52|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||126.52|-34.43|0.261
74057015|NCT01945034|147665211|SUPERIORITY_OR_OTHER||LS Mean Difference|37.3||||0.325|TWO_SIDED|95.0|-37.13|111.8|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||111.80|-37.13|0.325
74100825|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-X-C motif chemokine 16 (Q9H2A7) was analyzed.||||= 0.979
74100826|NCT05013008|147751352|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Dickkopf-related protein 3 (Q9UBP4) was analyzed.||||= 0.979
74100827|NCT02640482|147751402|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides \>90% power to demonstrate noninferiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of using a single binomial proportion a one-sample test for superiority).||100.0|98.5|
74057016|NCT01945034|147665211|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.7||||0.849|TWO_SIDED|95.0|-98.64|81.22|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||81.22|-98.64|0.849
74057017|NCT01945034|147665212|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.042|TWO_SIDED|95.0|0.0|0.49|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.49|0.0|0.042
74057018|NCT01945034|147665212|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.114|TWO_SIDED|95.0|-0.04|0.4|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.40|-0.04|0.114
74100828|NCT02640482|147751403|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 95% to achieve superiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides \>90% power to demonstrate superiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of a single binomial proportion using a one-sample test for superiority).||100.0|98.5|
74100829|NCT04933383|147751414|SUPERIORITY||difference/ratio of least square means|180.6||||0.000813|TWO_SIDED|95.0|106.42|306.48|||ANCOVA|||"The primary efficacy endpoint is the change from baseline in PC20 after each treatment period (baseline is defined at Visit 1).~For primary efficacy analysis, the mean PC20 changes from baseline between AQ001S and the comparator were compared by analysis of covariance (ANCOVA) for crossover design. A p-value was calculated for the difference of the parameter between AQ001S and the comparator.~Additionally, an adjusted 95%-CI for the mean difference was obtained by the ANCOVA."||306.48|106.42|0.000813
74100830|NCT00180661|147751416|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
74100831|NCT00180661|147751417|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
73881718|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.64||0.9133|TWO_SIDED|95.0|-3.4|3.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||3.04|-3.40|0.9133
74019811|NCT01360645|147591705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0109|TWO_SIDED|95.0|-0.27|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.04|-0.27|0.0109
74100832|NCT00230178|147751453|SUPERIORITY_OR_OTHER||Difference in response rate %|21.0||||0.0009||95.0|8.6|32.7|||Wilson's method|||||32.7|8.6|0.0009
74100833|NCT00230178|147751453|SUPERIORITY_OR_OTHER||Difference in response rate %|12.3||||0.0632||95.0|-0.9|25.0|||Wilson's method|||||25.0|-0.9|0.0632
74100834|NCT00230178|147751454|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
74100835|NCT00230178|147751454|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
74100836|NCT01753297|147751457|OTHER|||||||0.158|||||||Log Rank|||A two-sided log-rank test was used to compare time to BRFS between both treatment groups.|Analysis on BRFS was based on 61 BR events (comprised of 35 BR events in the active surveillance arm and 26 BR events in the triptorelin arm).|||0.158
74100837|NCT01753297|147751457|OTHER||Hazard Ratio (HR)|0.65||||0.1|TWO_SIDED|95.0|0.38|1.09|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute hazards ratios (HRs) and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||1.09|0.38|0.100
74100838|NCT01753297|147751457|OTHER||Hazard Ratio (HR)|1.49||||0.502|TWO_SIDED|95.0|0.46|4.79|||Regression, Cox|||"Comparison between countries: Russia compared to China.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and country: p=0.970.|4.79|0.46|0.502
74100839|NCT01753297|147751457|OTHER|||||||0.671|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and centre: p=0.241.|||0.671
73888189|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.0096|TWO_SIDED|95.0|1.7|11.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.9|1.7|0.0096
74019812|NCT01360645|147591705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1286|TWO_SIDED|95.0|-0.25|0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||0.03|-0.25|0.1286
74019813|NCT01360645|147591705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0521|TWO_SIDED|95.0|-0.32|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.00|-0.32|0.0521
74019814|NCT01360645|147591705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0084|TWO_SIDED|95.0|-0.42|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-0.06|-0.42|0.0084
73881719|NCT03192176|147297635|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.63||0.1078|TWO_SIDED|95.0|-5.85|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.58|-5.85|0.1078
73881720|NCT03192176|147297635|SUPERIORITY||LSMean differencce|-1.9|STANDARD_ERROR_OF_MEAN|1.08||0.0719|TWO_SIDED|95.0|-4.07|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.18|-4.07|0.0719
73881721|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|1.09||0.1298|TWO_SIDED|95.0|-3.8|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.49|-3.80|0.1298
74057019|NCT01945034|147665212|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.598|TWO_SIDED|95.0|-0.34|0.2|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.||0.20|-0.34|0.598
74057020|NCT01945034|147665212|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.24|0.19|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.19|-0.24|0.833
74057021|NCT01945034|147665212|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.853|TWO_SIDED|95.0|-0.18|0.22|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.18|0.853
74057022|NCT01945034|147665212|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.733|TWO_SIDED|95.0|-0.2|0.29|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.||0.29|-0.20|0.733
74057023|NCT01945034|147665214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.016|TWO_SIDED|95.0|1.07|1.97|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the Proportional Hazards (PH) model with treatment, BLPSR, and pooled site blocks.||1.97|1.07|0.016
74100840|NCT01753297|147751457|OTHER||Hazard Ratio (HR)|2.35||||0.093|TWO_SIDED|95.0|0.87|6.39|||Regression, Cox|||"Comparison between Gleason score categories: Gleason score of =7 compared to Gleason score ≤6.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and Gleason score: p=0.272.|6.39|0.87|0.093
74100841|NCT01753297|147751457|OTHER||Hazard Ratio (HR)|2.03||||0.168|TWO_SIDED|95.0|0.74|5.55|||Regression, Cox|||"Comparison between Gleason score categories: Gleason score of ≥8 compared to Gleason score ≤6.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||5.55|0.74|0.168
74100842|NCT01753297|147751459|OTHER|||||||0.639|||||||Log Rank|||A two-sided log-rank test was used to compare time to EFS between both treatment groups.|Analysis was based on 2 EFS events in the active surveillance arm and 3 EFS events in the triptorelin arm.|||0.639
74100843|NCT01753297|147751459|OTHER||Hazard Ratio (HR)|1.52||||0.653|TWO_SIDED|95.0|0.24|9.59|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||9.59|0.24|0.653
74100844|NCT01753297|147751459|OTHER|||||||0.999|||||||Regression, Cox|||"Country effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.999
73881722|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.9532|TWO_SIDED|95.0|-2.26|2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.13|-2.26|0.9532
73881723|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|1.12||0.751|TWO_SIDED|95.0|-1.84|2.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.55|-1.84|0.7510
73888190|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|33.0|||<|0.0001|TWO_SIDED|95.0|20.0|45.9|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.9|20.0|<0.0001
74100845|NCT01753297|147751459|OTHER|||||||1|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||1.000
74100846|NCT01753297|147751459|OTHER|||||||0.583|||||||Regression, Cox|||"Gleason score effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.583
74100847|NCT01753297|147751461|OTHER|||||||0.557|||||||Log Rank|||A two-sided log-rank test was used to compare time to OS between both treatment groups.|1 death occurred in the active surveillance arm and 2 deaths occurred in the triptorelin arm.|||0.557
74100848|NCT01753297|147751464|OTHER|||||||0.525|||||||Log Rank|||A two-sided log-rank test was used to compare PSADT between both treatment groups.|Analysis was based on 9 PSADT events in the active surveillance arm and 6 PSADT events in the triptorelin arm.|||0.525
74100849|NCT01753297|147751464|OTHER||Hazard Ratio (HR)|1.72||||0.435|TWO_SIDED|95.0|0.44|6.73|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||6.73|0.44|0.435
74100850|NCT01753297|147751464|OTHER|||||||0.761|||||||Regression, Cox|||"Country effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.761
74100851|NCT01753297|147751464|OTHER|||||||0.652|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.652
74019815|NCT01360645|147591705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0003|TWO_SIDED|95.0|-0.54|-0.16|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-0.16|-0.54|0.0003
74019816|NCT01360645|147591705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0006|TWO_SIDED|95.0|-0.53|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||-0.15|-0.53|0.0006
74019817|NCT01360645|147591706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.0139|TWO_SIDED|95.0|-2.82|-0.32|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.32|-2.82|0.0139
74019818|NCT01360645|147591706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0436|TWO_SIDED|95.0|-3.01|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.04|-3.01|0.0436
74019819|NCT01360645|147591706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.1903|TWO_SIDED|95.0|-2.75|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.55|-2.75|0.1903
74019820|NCT01360645|147591706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.47||||0.0951|TWO_SIDED|95.0|-3.21|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||0.26|-3.21|0.0951
74019821|NCT01360645|147591706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.0626|TWO_SIDED|95.0|-3.59|0.09|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||0.09|-3.59|0.0626
74019822|NCT01360645|147591706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96||||0.0435|TWO_SIDED|95.0|-3.87|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||-0.06|-3.87|0.0435
74019823|NCT01360645|147591707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.0069|TWO_SIDED|95.0|-2.95|-0.47|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.47|-2.95|0.0069
74019824|NCT01360645|147591707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.1322|TWO_SIDED|95.0|-2.68|0.35|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||0.35|-2.68|0.1322
74019825|NCT01360645|147591707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.4055|TWO_SIDED|95.0|-2.41|0.98|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.98|-2.41|0.4055
74019826|NCT01360645|147591707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.1715|TWO_SIDED|95.0|-3.08|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||0.55|-3.08|0.1715
74100852|NCT01753297|147751464|OTHER|||||||0.726|||||||Regression, Cox|||"Gleason score effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.726
74057024|NCT01945034|147665214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.022|TWO_SIDED|95.0|0.53|0.95|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.95|0.53|0.022
74057025|NCT01945034|147665214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.34|0.69|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.69|0.34|< 0.001
74057026|NCT01945034|147665214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79|||<|0.001|TWO_SIDED|95.0|1.27|2.51|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||2.51|1.27|< 0.001
74057027|NCT01945034|147665214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.009|TWO_SIDED|95.0|0.41|0.88|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.88|0.41|0.009
74057028|NCT01945034|147665214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.22|0.52|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.52|0.22|< 0.001
74057029|NCT01945034|147665216|SUPERIORITY_OR_OTHER|||||||0.479|||||||Cochran-Mantel-Haenszel|p-values from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for BLPSR and site block.||||||0.479
73881724|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.11||0.112|TWO_SIDED|95.0|-3.95|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.42|-3.95|0.1120
74057030|NCT01945034|147665216|SUPERIORITY_OR_OTHER|||||||0.279|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.||||||0.279
74057031|NCT01945034|147665216|SUPERIORITY_OR_OTHER|||||||0.129|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.||||||0.129
74057032|NCT02706327|147665222|OTHER||||||<|0.001||||||A post-hoc test was used with Bonferroni correction and adjusted p-value was 0.016.|Kruskal-Wallis|Effect sizes (Cohen's d) were calculated for significant differences.||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not. A post-hoc test was used with Bonferroni correction.||||<0.001
74057033|NCT02706327|147665223|OTHER|||||||0.547|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.547
74057034|NCT02706327|147665224|OTHER|||||||0.895|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.895
74057035|NCT02706327|147665225|OTHER|||||||0.842|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.842
74057036|NCT02706327|147665226|OTHER|||||||0.848|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.848
74057037|NCT03471507|147665227|OTHER|||||||0.46|||||||Regression, Linear|Adjusted for age and sex.||||||0.46
73881725|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|1.1||0.9781|TWO_SIDED|95.0|-2.13|2.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.19|-2.13|0.9781
74057038|NCT03246152|147665238|OTHER||||||>|0.05|||||||Pearson's correlation coefficient|||Correlation between change in BCVA and the pre treatment, post treatment, and change in vascular density following 3-6 injections was performed.||||>0.05
74057039|NCT01374516|147665239|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|60.8|||||TWO_SIDED|95.0|52.0|68.0||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow \& Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.||68.0|52.0|
74057040|NCT01374516|147665240|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|64.7|||||TWO_SIDED|95.0|58.7|69.8||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||69.8|58.7|
74100853|NCT03577301|147751470|SUPERIORITY||Wald Chi Square|3.3||||0.35|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 3 months.||||||0.35
74100854|NCT03577301|147751470|SUPERIORITY||Wald Chi Square|1.97||||0.58|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 6 months.||||||0.58
74100855|NCT03577301|147751470|SUPERIORITY||Wald Chi Square|1.68||||0.64|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 9 months.||||||0.64
74100856|NCT03577301|147751470|SUPERIORITY||Wald Chi Square|1.15||||0.76|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 12 months.||||||0.76
73881726|NCT03192176|147297635|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1||0.206|TWO_SIDED|95.0|-3.57|0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.77|-3.57|0.2060
74019827|NCT01360645|147591707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.1424|TWO_SIDED|95.0|-3.33|0.48|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||0.48|-3.33|0.1424
73888191|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.8009|TWO_SIDED|95.0|-11.2|14.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.4|-11.2|0.8009
74019828|NCT01360645|147591707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.127|TWO_SIDED|95.0|-3.52|0.44|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||0.44|-3.52|0.1270
74019829|NCT01360645|147591708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.3079|TWO_SIDED|95.0|-0.81|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11||0.26|-0.81|0.3079
74019830|NCT01360645|147591708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4771|TWO_SIDED|95.0|-0.73|0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 14||0.34|-0.73|0.4771
74019831|NCT01360645|147591708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0195|TWO_SIDED|95.0|-0.92|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 11||-0.08|-0.92|0.0195
74019832|NCT01360645|147591708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0323|TWO_SIDED|95.0|-0.96|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 14||-0.04|-0.96|0.0323
74019833|NCT01360645|147591708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.0058|TWO_SIDED|95.0|-1.07|-0.18|||Cochran-Mantel-Haenszel|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 11||-0.18|-1.07|0.0058
74019834|NCT01360645|147591708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0129|TWO_SIDED|95.0|-1.07|-0.13|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 14||-0.13|-1.07|0.0129
74019835|NCT01360645|147591709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.5151|TWO_SIDED|95.0|-0.71|0.36|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 11||0.36|-0.71|0.5151
74019836|NCT01360645|147591709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.608|TWO_SIDED|95.0|-0.7|0.41|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 14||0.41|-0.70|0.6080
74019837|NCT01360645|147591709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0267|TWO_SIDED|95.0|-0.92|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 11||-0.06|-0.92|0.0267
74019838|NCT01360645|147591709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0224|TWO_SIDED|95.0|-1.01|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 14||-0.08|-1.01|0.0224
74019839|NCT01360645|147591709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0146|TWO_SIDED|95.0|-1.01|-0.11|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 11||-0.11|-1.01|0.0146
74019840|NCT01360645|147591709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0113|TWO_SIDED|95.0|-1.09|-0.14|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 14||-0.14|-1.09|0.0113
74019841|NCT01360645|147591710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34||||0.0001|TWO_SIDED|95.0|-3.47|-1.22|||ANCOVA|||ANCOVA\_Last observation carry forward (LOCF) model with treatment and trial site as main effects, and baseline (end of Phase A \[Week 8\]) value as a covariate was used.||-1.22|-3.47|0.0001
74019842|NCT01360645|147591711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||0.0002|TWO_SIDED|95.0|-3.47|-1.12|||ANCOVA|||||-1.12|-3.47|0.0002
74019843|NCT01360645|147591712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0219|TWO_SIDED|95.0|-2.17|-0.17|||ANCOVA|||ANCOVA\_LOCF model with treatment and trial site as main effects, and baseline (end of Phase A \[Week 8\]) value as a covariate was used.||-0.17|-2.17|0.0219
74019844|NCT01360645|147591713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.0376|TWO_SIDED|95.0|-2.13|-0.06|||ANCOVA|||||-0.06|-2.13|0.0376
74019845|NCT01360645|147591714|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.63||||0.0176|TWO_SIDED|95.0|1.09|2.44|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.44|1.09|0.0176
74019846|NCT01360645|147591715|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.54||||0.0429|TWO_SIDED|95.0|1.01|2.35|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.35|1.01|0.0429
74019847|NCT01360645|147591716|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.68||||0.0586|TWO_SIDED|95.0|0.98|2.86|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.86|0.98|0.0586
74019848|NCT01360645|147591717|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.67||||0.0671|TWO_SIDED|95.0|0.97|2.9|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.90|0.97|0.0671
74019849|NCT01360645|147591718|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.61||||0.0003|TWO_SIDED|95.0|1.23|2.1|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.10|1.23|0.0003
74019850|NCT01360645|147591719|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.69||||0.0002|TWO_SIDED|95.0|1.27|2.27|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.27|1.27|0.0002
74019851|NCT01948830|147591748|NON_INFERIORITY_OR_EQUIVALENCE|The following hypothesis was tested at a one-sided 0.025 level. Non-inferiority with respect to BCVA: H01: μtreat and extend - μmonthly ≤ - Δ versus HA1: μtreat and extend - μmonthly \> - Δ where μtreat and extend and μmonthly are the unknown mean changes from baseline in BCVA to Month 12 in the treat and extend regimen and the monthly regimen, respectively. Δ is the non-inferiority margin and is pre-defined to be 5 letters for the justification of the margin.|||||<|0.001|||||||ANCOVA|||||||<0.001
74019852|NCT01890421|147591766|SUPERIORITY||Sensitivity Difference|-0.7||||0.8694|ONE_SIDED|95.0|-8.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||-8.5|0.8694
74019853|NCT01890421|147591766|SUPERIORITY||Sensitivity Difference|29.1|||<|0.0001|ONE_SIDED|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||21.7|<0.0001
74057041|NCT01374516|147665241|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|64.7|||||TWO_SIDED|95.0|58.7|69.9||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||69.9|58.7|
74057042|NCT01374516|147665242|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|61.9|||||TWO_SIDED|95.0|54.7|68.0||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||68.0|54.7|
74057043|NCT01050998|147665283|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.578|TWO_SIDED|95.0|-11.5|22.0|||Fisher Exact||95 percent (%) unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||22.0|-11.5|0.578
74057044|NCT01050998|147665283|SUPERIORITY_OR_OTHER||Percent difference|30.7|||<|0.001|TWO_SIDED|95.0|13.4|46.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||46.3|13.4|<0.001
74057045|NCT01050998|147665283|SUPERIORITY_OR_OTHER||Percent difference|15.3||||0.099|TWO_SIDED|95.0|-1.6|32.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||32.2|-1.6|0.099
74057046|NCT01050998|147665283|SUPERIORITY_OR_OTHER||Percent difference|35.5|||<|0.001|TWO_SIDED|95.0|17.8|50.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||50.6|17.8|<0.001
74057047|NCT01050998|147665284|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.543|TWO_SIDED|95.0|-11.9|25.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||25.4|-11.9|0.543
74057048|NCT01050998|147665284|SUPERIORITY_OR_OTHER||Percent difference|26.3||||0.011|TWO_SIDED|95.0|7.2|43.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||43.6|7.2|0.011
74100857|NCT03577301|147751471|SUPERIORITY||Wald Chi Square|3.08||||0.38|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 3 months.||||||0.38
74100858|NCT03577301|147751471|SUPERIORITY||Wald Chi Square|1.26||||0.74|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 6 months.||||||0.74
74100859|NCT03577301|147751471|SUPERIORITY||Wald Chi Square|1.27||||0.74|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 9 months.||||||0.74
74100860|NCT03577301|147751471|SUPERIORITY||Slope|3.66||||0.3|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 12 months.||||||0.300
74057049|NCT01050998|147665284|SUPERIORITY_OR_OTHER||Percent difference|16.6||||0.108|TWO_SIDED|95.0|-2.5|35.5|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||35.5|-2.5|0.108
74057050|NCT01050998|147665284|SUPERIORITY_OR_OTHER||Percent difference|32.0||||0.001|TWO_SIDED|95.0|12.5|49.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||49.0|12.5|0.001
74057051|NCT01050998|147665284|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-33.7|35.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||35.7|-33.7|1.000
74057052|NCT01050998|147665284|SUPERIORITY_OR_OTHER||Percent difference|51.5||||0.028|TWO_SIDED|95.0|8.2|77.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||77.0|8.2|0.028
74100861|NCT03577301|147751472|SUPERIORITY||Wald Chi Square|1.3||||0.73|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 3 months.||||||0.73
74100862|NCT03577301|147751472|SUPERIORITY||Wald Chi Square|1.68||||0.64|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 6 months.||||||0.64
74057053|NCT01050998|147665284|SUPERIORITY_OR_OTHER||Percent difference|9.8||||0.661|TWO_SIDED|95.0|-24.3|46.9|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||46.9|-24.3|0.661
74057054|NCT01050998|147665285|SUPERIORITY_OR_OTHER||Percent difference|13.0||||0.152|TWO_SIDED|95.0|-4.2|30.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||30.3|-4.2|0.152
74057055|NCT01050998|147665285|SUPERIORITY_OR_OTHER||Percent difference|24.3||||0.008|TWO_SIDED|95.0|7.0|40.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||40.3|7.0|0.008
74057056|NCT01050998|147665285|SUPERIORITY_OR_OTHER||Percent difference|21.4||||0.02|TWO_SIDED|95.0|3.9|37.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||37.8|3.9|0.020
74100863|NCT03577301|147751472|SUPERIORITY||Wald Chi Square|0.64||||0.89|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 9 months.||||||0.89
74100864|NCT03577301|147751472|SUPERIORITY||Wald Chi Square|1.08||||0.78|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 12 months.||||||0.78
74100865|NCT03577301|147751473|SUPERIORITY||Wald Chi Square|2.37||||0.5|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 3 months.||||||0.50
74100866|NCT03577301|147751473|SUPERIORITY||Wald Chi Square|2.98||||0.34|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 6 months.||||||0.34
74100867|NCT03577301|147751473|SUPERIORITY||Wald Chi Square|1.59||||0.66|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 9 months.||||||0.66
74100868|NCT03577301|147751473|SUPERIORITY||Wald Chi Square|2.74||||0.43|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 12 months.||||||0.43
74100869|NCT01931878|147751476|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||t-test, 2 sided|||comparison of mean RLS Scale scores between 21 incoA and 21 saline injections||||0.031
74057057|NCT01050998|147665285|SUPERIORITY_OR_OTHER||Percent difference|29.0||||0.002|TWO_SIDED|95.0|11.3|45.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||45.0|11.3|0.002
74057058|NCT01050998|147665286|SUPERIORITY_OR_OTHER||Percent difference|9.9||||0.328|TWO_SIDED|95.0|-9.3|29.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||29.4|-9.3|0.328
74057059|NCT01050998|147665286|SUPERIORITY_OR_OTHER||Percent difference|17.2||||0.084|TWO_SIDED|95.0|-2.0|35.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||35.6|-2.0|0.084
74057060|NCT01050998|147665286|SUPERIORITY_OR_OTHER||Percent difference|20.2||||0.049|TWO_SIDED|95.0|0.7|38.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||38.2|0.7|0.049
74057061|NCT01050998|147665286|SUPERIORITY_OR_OTHER||Percent difference|22.8||||0.03|TWO_SIDED|95.0|3.2|40.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||40.7|3.2|0.030
74057062|NCT01050998|147665286|SUPERIORITY_OR_OTHER||Percent difference|26.8||||0.188|TWO_SIDED|95.0|-9.3|60.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||60.7|-9.3|0.188
74057063|NCT01050998|147665286|SUPERIORITY_OR_OTHER||Percent difference|57.4||||0.01|TWO_SIDED|95.0|15.2|81.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||81.8|15.2|0.010
74100870|NCT01931878|147751477|SUPERIORITY_OR_OTHER|||||||0.0088|TWO_SIDED||||||Fisher Exact|||||||0.0088
74100871|NCT01931878|147751478|SUPERIORITY_OR_OTHER|||||||0.0855|TWO_SIDED||||||Fisher Exact|||||||0.0855
73888192|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|17.4||||0.0086|TWO_SIDED|95.0|4.5|30.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.3|4.5|0.0086
74057064|NCT01050998|147665307|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.205||0.137|TWO_SIDED|95.0|-0.71|0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.10|-0.71|0.137
74057065|NCT01050998|147665307|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.202||0.001|TWO_SIDED|95.0|-1.07|-0.27|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.27|-1.07|0.001
74057066|NCT01050998|147665307|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.201||0.08|TWO_SIDED|95.0|-0.75|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.04|-0.75|0.080
74057067|NCT01050998|147665307|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.204|<|0.001|TWO_SIDED|95.0|-1.14|-0.33|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.33|-1.14|<0.001
74057068|NCT01050998|147665307|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.212||0.107|TWO_SIDED|95.0|-0.76|0.08|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.08|-0.76|0.107
74057069|NCT01050998|147665307|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.17|-0.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.35|-1.17|<0.001
74057070|NCT01050998|147665307|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.209||0.046|TWO_SIDED|95.0|-0.83|-0.01|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.01|-0.83|0.046
74057071|NCT01050998|147665307|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.212|<|0.001|TWO_SIDED|95.0|-1.22|-0.38|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.38|-1.22|<0.001
74100872|NCT04315506|147751521|SUPERIORITY||Odds Ratio (OR)|1.14||||0.5384|TWO_SIDED|95.0|0.75|1.72||The analysis was a two-intervention arm comparison. Adjustments for multiple tests and outcomes were not required.|Regression, Logistic||Odds of quitting in Enuf Snuff group (SGR) compared to Enough Snuff (control)|||1.72|0.75|0.5384
74100873|NCT04315506|147751522|SUPERIORITY||Slope|-0.1057||||0.6624|TWO_SIDED|95.0|-0.5808|0.3693||P-value above is for the treatment-by-time squared term in the statistical model for longitudinal data; quadratic change in outcome determined, compared trajectory of outcome change in EnufSnuff (SGR) compared to Enough Snuff (control)|Mixed Models Analysis|Multi-level, mixed-effects model for longitudinal data was conducted.|Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).|For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.||0.3693|-0.5808|0.6624
74100874|NCT04315506|147751523|SUPERIORITY||Slope|0.0946||||0.232|TWO_SIDED|95.0|-0.0609|0.2501||A multi-level, mixed-effects model for longitudinal data was applied. The p-value provided above was for the treatment-by-time effect used to test for differences in the trajectory of change in craving reduction between the two treatment groups.|Mixed Models Analysis|Multi-level, mixed-effects model for longitudinal data was conducted. (trajectory analysis)|Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).|For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.||0.2501|-0.0609|0.2320
74019854|NCT01890421|147591766|SUPERIORITY||Sensitivity Difference|24.1|||<|0.0001|ONE_SIDED|95.0|16.6||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||16.6|<0.0001
74019855|NCT01890421|147591767|SUPERIORITY||Sensitivity Difference]|7.4||||0.0455|ONE_SIDED|95.0|0.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||0.5|0.0455
74019856|NCT01890421|147591767|SUPERIORITY||Sensitivity Difference]|34.3|||<|0.0001|ONE_SIDED|95.0|25.2||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||25.2|<0.0001
74019857|NCT01890421|147591767|SUPERIORITY||Sensitivity Difference|30.6|||<|0.0001|ONE_SIDED|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||21.7|<0.0001
74019858|NCT01890421|147591772|SUPERIORITY||Sensitivity Difference|27.9|||<|0.0001|TWO_SIDED|95.0|18.5|35.8|||McNemar 2-sided test,alpha level of 5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.||35.8|18.5|<0.0001
74019859|NCT01890421|147591772|SUPERIORITY||Sensitivity Difference|27.9|||<|0.0001|TWO_SIDED|95.0|19.9|34.4|||McNemar 2-sided test,alpha level of 10%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.||34.4|19.9|<0.0001
74019860|NCT01260454|147591796|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||This is open-label, uncontrolled data; the comparison is made between each individual's baseline.||||0.03
74019861|NCT01446419|147591819|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|P-value from ANCOVA with factors of tx group, analysis center and tx group by analysis center interaction, and a covariate of baseline ODI score.||||||0.019
74019862|NCT01228903|147591822|EQUIVALENCE|(Doehner et al.) CHF patients on allopurinol (n= 14) had improved BA-FMD= 10.6 ± 2.0 (mean ± SE) vs placebo (n= 14, FMD= 6.7 ± 0.1); difference in means= 3.9. Yiginer et al. found a similar difference in metabolic syndrome. A sample size of 34/group will have 80% power to detect a difference in means of 3.9 (common standard deviation=5.6, two group t-test=0.050 two-sided significance). Accounting for a potential drop-out rate17%, n= 40/group was recruited.|Mean Difference (Net)|0.7||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The estimated value represents the difference between the change from baseline in both groups.|The null hypothesis was the there will be no difference between the placebo and allopurinol. The power for the study was calculated (as appropriate) based on the prior literature.||||0.47
74100875|NCT00919126|147751535|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.||The dose of propofol adjusted to BSA and maintenance duration was expected to be 4.0 mg/m².min in the control group, 2.8 mg/m².min in one xenon group and 3.0 mg/m².min in the other xenon group. With an expected common standard deviation of 2.0 mg/m².min, a type I error of 0.05 (two-sided) and a power of 0.80, the sample size required to show a statistically significant difference between the three groups was estimated to be 48 patients per group, resulting in a total of 144 randomised patients.||||<0.0001
74100876|NCT00919126|147751535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0256|||<|0.0001|TWO_SIDED|95.0|2.328|3.724||Pairwise comparison performed using Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Medical Air in Oxygen was assessed.|||3.724|2.328|<0.0001
74100877|NCT00919126|147751535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2905|||<|0.0001|TWO_SIDED|95.0|1.57|3.011||Pairwise comparison performed using Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 50% in Oxygen minus Medical Air in Oxygen was assessed.|||3.011|1.570|<0.0001
74100878|NCT00919126|147751535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7351||||0.0365|TWO_SIDED|95.0|0.038|1.432||Pairwise comparison was performed using the Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Xenon 50% in Oxygen was assessed|||1.432|0.038|0.0365
74100879|NCT02032680|147751549|SUPERIORITY|||||||0.3749|||||||Cochran-Armitage Trend Test|||The two treatments were compared to see whether participants in one achieved a higher level on their goals (i.e., the maximum level achieved on the goal).||||0.3749
74057072|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.086|TWO_SIDED|95.0|-0.85|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.06|-0.85|0.086
74057073|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.225||0.016|TWO_SIDED|95.0|-0.99|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.10|-0.99|0.016
74057074|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.225||0.059|TWO_SIDED|95.0|-0.87|0.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.02|-0.87|0.059
74057075|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.227||0.002|TWO_SIDED|95.0|-1.14|-0.25|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.25|-1.14|0.002
74100880|NCT00687830|147751554|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
74100881|NCT00687830|147751555|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||0.04
74100882|NCT00606632|147751556|SUPERIORITY|||||||0.023|||||||McNemar|||||||0.023
74057076|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.241||0.107|TWO_SIDED|95.0|-0.87|0.09|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.09|-0.87|0.107
74057077|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.236||0.007|TWO_SIDED|95.0|-1.11|-0.18|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.18|-1.11|0.007
74057078|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.236||0.084|TWO_SIDED|95.0|-0.88|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.06|-0.88|0.084
74100883|NCT00606632|147751556|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
74100884|NCT00711880|147751560|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.96||||0.004|TWO_SIDED|95.0|-1.59|-0.32|||ANCOVA|||The change in Numerical Rating Scale Peripheral Neuropathic Pain scores was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale Peripheral Neuropathic Pain score as a covariate.||-0.32|-1.59|0.004
74100885|NCT00711880|147751561|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-8.03||||0.007|TWO_SIDED|95.0|-13.83|-2.23|||ANCOVA|||The change in Neuropathic Pain Scale scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Neuropathic Pain Scale score as a covariate.||-2.23|-13.83|0.007
74057079|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.238||0.002|TWO_SIDED|95.0|-1.2|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.26|-1.20|0.002
74057080|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.447||0.785|TWO_SIDED|95.0|-0.78|1.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||1.02|-0.78|0.785
74057081|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.465||0.014|TWO_SIDED|95.0|-2.13|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.26|-2.13|0.014
74057082|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.448||0.931|TWO_SIDED|95.0|-0.94|0.86|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.86|-0.94|0.931
74057083|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.465||0.07|TWO_SIDED|95.0|-1.8|0.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.07|-1.80|0.070
74057084|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.449||0.854|TWO_SIDED|95.0|-0.99|0.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.82|-0.99|0.854
74100886|NCT00711880|147751562|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.43||||0.001|TWO_SIDED|95.0|-0.67|-0.19|||ANCOVA|||The change in sleep disturbance scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline sleep disturbance score as a covariate.||-0.19|-0.67|0.001
74100887|NCT00711880|147751563|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.85||||0.003|TWO_SIDED|95.0|-9.62|-2.09|||ANCOVA|||The change in total Pain Disability Index scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total Pain Disability Index score as a covariate.||-2.09|-9.62|0.003
74100888|NCT00711880|147751564|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.82||||0.042|TWO_SIDED|95.0|-1.6|-0.03|||ANCOVA|||The change in Dynamic Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Dynamic Allodynia Test score as a covariate.||-0.03|-1.60|0.042
74100889|NCT00711880|147751565|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|12.73||||0.144|TWO_SIDED|95.0|-4.4|29.85|||ANCOVA|||The change in Static Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Static Allodynia Test score as a covariate.||29.85|-4.40|0.144
74057085|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.468||0.011|TWO_SIDED|95.0|-2.19|-0.31|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.31|-2.19|0.011
74057086|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.448||0.271|TWO_SIDED|95.0|-1.4|0.4|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.40|-1.40|0.271
74057087|NCT01050998|147665308|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.465||0.031|TWO_SIDED|95.0|-1.97|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.10|-1.97|0.031
74057088|NCT01050998|147665309|SUPERIORITY_OR_OTHER||Percent difference|7.0||||0.238|TWO_SIDED|95.0|-3.3|20.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||20.5|-3.3|0.238
74057089|NCT01050998|147665309|SUPERIORITY_OR_OTHER||Percent difference|14.8||||0.017|TWO_SIDED|95.0|2.8|29.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||29.7|2.8|0.017
74100890|NCT00711880|147751566|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.75||||0.483|TWO_SIDED|95.0|-2.84|1.35|||ANCOVA|||The change in total General Health Questionnaire score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total General Health Questionnaire score as a covariate.||1.35|-2.84|0.483
74100891|NCT00711880|147751567|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.02||||0.924|TWO_SIDED|95.0|-0.46|0.5|||ANCOVA|||The change in selective reminding test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline selective reminding test score as a covariate.||0.50|-0.46|0.924
74019863|NCT02867761|147591828|SUPERIORITY||Odds Ratio (OR)|0.91||||0.65|TWO_SIDED|95.0|0.6|1.37|||Generalized Estimating Equation|||||1.37|0.60|0.65
74019864|NCT02867761|147591832|SUPERIORITY|||||||0.3|||||||Linear Mixed Effects Model|||||||0.30
74019865|NCT02867761|147591833|SUPERIORITY|||||||0.49|||||||Linear Mixed Effects Model|||||||0.49
74019866|NCT02867761|147591834|SUPERIORITY|||||||0.96|||||||Linear Mixed Effects Model|||||||0.96
74019867|NCT02867761|147591835|SUPERIORITY||||||<|0.001|||||||Linear Mixed Effects Model|||||||<0.001
74019868|NCT02867761|147591838|SUPERIORITY|||||||0.35|||||||Linear Mixed Effects Model|||P Value for percentage of days with any symptoms (shortness of breath, chest tightness, wheezing, cough, or sputum)||||0.35
74019869|NCT02867761|147591838|SUPERIORITY|||||||0.61|||||||Linear Mixed Effects Model|||P Value for percentage of days with shortness of breath||||0.61
74019870|NCT02867761|147591838|SUPERIORITY|||||||0.48|||||||Linear Mixed Effects Model|||P Value for percentage of days with chest tightness||||0.48
74019871|NCT02867761|147591838|SUPERIORITY|||||||0.81|||||||Linear Mixed Effects Model|||P Value for percentage of days with wheezing||||0.81
74019872|NCT02867761|147591838|SUPERIORITY|||||||0.17|||||||Linear Mixed Effects Model|||P Value for percentage of days with cough||||0.17
74019873|NCT02867761|147591838|SUPERIORITY|||||||0.64|||||||Linear Mixed Effects Model|||P Value for percentage of days with sputum||||0.64
74019874|NCT02867761|147591838|SUPERIORITY|||||||0.84|||||||Linear Mixed Effects Model|||P Value for percentage of days with use of albuterol.||||0.84
74019875|NCT04506294|147591846|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||||||.536
74019876|NCT02525549|147591870|NON_INFERIORITY|provides 85% power of success|Equivalence ratio|93.12|||||TWO_SIDED|90.0|88.6|102.0|||Fieller's method|||||102.00|88.6|
74019877|NCT02525549|147591871|NON_INFERIORITY|provides 85% power of success|Equivalence ratio|98.7|||||TWO_SIDED|90.0|92.3|109.4|||Fieller's method|||||109.4|92.3|
74019878|NCT01445678|147591904|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-4.2|||||TWO_SIDED|95.0|-8.91|0.54||||||||0.54|-8.91|
74019879|NCT01445678|147591905|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-4.52|2.59||||||||2.59|-4.52|
74019880|NCT01445678|147591906|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.23|0.89||||||||0.89|-7.23|
74019881|NCT01445678|147591907|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-3.4|2.33||||||||2.33|-3.4|
74019882|NCT01445678|147591908|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-9.09|0.94||||||||0.94|-9.09|
74019883|NCT01445678|147591909|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-0.88|2.37||||||||2.37|-0.88|
74057090|NCT01050998|147665309|SUPERIORITY_OR_OTHER||Percent difference|11.1||||0.09|TWO_SIDED|95.0|0.0|25.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||25.4|0.0|0.090
74057091|NCT01050998|147665309|SUPERIORITY_OR_OTHER||Percent difference|15.8||||0.015|TWO_SIDED|95.0|2.9|31.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||31.0|2.9|0.015
74057092|NCT01050998|147665309|SUPERIORITY_OR_OTHER||Percent difference|3.0||||0.412|TWO_SIDED|95.0|-4.2|14.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||14.0|-4.2|0.412
74057093|NCT01050998|147665309|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.237|TWO_SIDED|95.0|-2.9|16.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||16.4|-2.9|0.237
74057094|NCT01050998|147665309|SUPERIORITY_OR_OTHER||Percent difference|5.1||||0.231|TWO_SIDED|95.0|-2.8|16.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||16.8|-2.8|0.231
74057095|NCT01050998|147665309|SUPERIORITY_OR_OTHER||Percent difference|3.1||||0.406|TWO_SIDED|95.0|-4.1|14.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||14.4|-4.1|0.406
74057096|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|8.7||||0.182|TWO_SIDED|95.0|-2.7|24.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||24.4|-2.7|0.182
74057097|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|10.4||||0.11|TWO_SIDED|95.0|-1.2|25.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||25.5|-1.2|0.110
74057098|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|11.3||||0.104|TWO_SIDED|95.0|-0.6|26.9|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||26.9|-0.6|0.104
74057099|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|16.4||||0.016|TWO_SIDED|95.0|3.5|32.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||32.7|3.5|0.016
74057100|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.115|TWO_SIDED|95.0|-1.0|19.3|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||19.3|-1.0|0.115
74057101|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|8.4||||0.052|TWO_SIDED|95.0|0.6|21.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||21.6|0.6|0.052
74057102|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
74057103|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|38.2||||0.059|TWO_SIDED|95.0|1.6|71.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||71.2|1.6|0.059
74057104|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|10.5||||0.591|TWO_SIDED|95.0|-18.2|46.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||46.2|-18.2|0.591
74057105|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|13.2||||0.57|TWO_SIDED|95.0|-16.6|51.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||51.4|-16.6|0.570
74057106|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
74057107|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||1|TWO_SIDED|95.0|-37.5|22.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||22.6|-37.5|1.000
74057108|NCT01050998|147665310|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
74100892|NCT00711880|147751568|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.53||||0.214|TWO_SIDED|95.0|-0.31|1.38|||ANCOVA|||The change in 10/36 spatial recall test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline 10/36 spatial recall test score as a covariate.||1.38|-0.31|0.214
74100893|NCT00711880|147751569|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.15||||0.158|TWO_SIDED|95.0|-5.15|0.85|||ANCOVA|||The change in symbol digit modalities test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline symbol digit modalities test score as a covariate.||0.85|-5.15|0.158
73888193|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|17.2||||0.0089|TWO_SIDED|95.0|4.4|30.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.0|4.4|0.0089
74057109|NCT01050998|147665311|SUPERIORITY_OR_OTHER||Percent difference|||||0.604|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||0.604
74057110|NCT01050998|147665311|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||<0.001
74057111|NCT01050998|147665311|SUPERIORITY_OR_OTHER|||||||0.145|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||0.145
74057112|NCT01050998|147665311|SUPERIORITY_OR_OTHER|||||||0.282|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||0.282
74057113|NCT01050998|147665311|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||<0.001
74057114|NCT01050998|147665311|SUPERIORITY_OR_OTHER|||||||0.047|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||0.047
74057115|NCT01050998|147665312|SUPERIORITY_OR_OTHER||Percent difference|||||0.237|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.237
74057116|NCT01050998|147665312|SUPERIORITY_OR_OTHER|||||||0.005|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.005
74057117|NCT01050998|147665312|SUPERIORITY_OR_OTHER|||||||0.134|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.134
74057118|NCT01050998|147665312|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||<0.001
74057119|NCT01050998|147665312|SUPERIORITY_OR_OTHER|||||||0.265|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.265
74057120|NCT01050998|147665312|SUPERIORITY_OR_OTHER|||||||0.013|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.013
74057121|NCT01050998|147665312|SUPERIORITY_OR_OTHER|||||||0.952|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.952
74057122|NCT01050998|147665312|SUPERIORITY_OR_OTHER|||||||0.004|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.004
74057123|NCT01050998|147665312|SUPERIORITY_OR_OTHER|||||||0.246|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||0.246
74057124|NCT01050998|147665312|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||<0.001
74057125|NCT01050998|147665312|SUPERIORITY_OR_OTHER|||||||0.126|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||0.126
74057126|NCT01050998|147665312|SUPERIORITY_OR_OTHER|||||||0.831|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.831
74057127|NCT01050998|147665312|SUPERIORITY_OR_OTHER|||||||0.005|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.005
74057128|NCT01050998|147665312|SUPERIORITY_OR_OTHER|||||||0.125|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.125
74057129|NCT01050998|147665312|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||<0.001
74057130|NCT01050998|147665313|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.15||||0.486|TWO_SIDED|95.0|0.78|1.69|||Exponential,Weibull and Log normal model||Ratio greater than (\>) 1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||1.69|0.78|0.486
74057131|NCT01050998|147665313|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.54||||0.015|TWO_SIDED|95.0|1.09|2.18|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.18|1.09|0.015
74057132|NCT01050998|147665313|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.65||||0.006|TWO_SIDED|95.0|1.15|2.36|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.36|1.15|0.006
74057133|NCT01050998|147665313|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|2.09|||<|0.001|TWO_SIDED|95.0|1.49|2.93|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.93|1.49|<0.001
74100894|NCT00711880|147751570|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.28||||0.656|TWO_SIDED|95.0|-4.47|7.04|||ANCOVA|||The change in paced auditory serial addition task score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline paced auditory serial addition task test score as a covariate.||7.04|-4.47|0.656
74057134|NCT01050998|147665313|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|0.97||||0.906|TWO_SIDED|95.0|0.61|1.55|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||1.55|0.61|0.906
74057135|NCT01050998|147665313|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.89|||<|0.001|TWO_SIDED|95.0|1.31|2.71|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||2.71|1.31|<0.001
74057136|NCT01050998|147665313|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.26||||0.272|TWO_SIDED|95.0|0.83|1.91|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||1.91|0.83|0.272
74100895|NCT00711880|147751571|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.962|TWO_SIDED|95.0|-3.56|3.39|||ANCOVA|||The change in word list generation test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline word list generation test score as a covariate.||3.39|-3.56|0.962
74100896|NCT00711880|147751572|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|32.26|||<|0.001|TWO_SIDED|95.0|16.4|48.12|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups for each question, using Fisher's Exact Test.||48.12|16.40|<0.001
74057137|NCT01050998|147665313|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.91|||<|0.001|TWO_SIDED|95.0|1.34|2.72|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||2.72|1.34|<0.001
74057138|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|4.7||||0.589|TWO_SIDED|95.0|-12.1|22.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||22.0|-12.1|0.589
74057139|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|20.2||||0.032||95.0|2.8|36.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||36.7|2.8|0.032
74057140|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|0.5||||1|TWO_SIDED|95.0|-16.0|18.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||18.0|-16.0|1.000
74057141|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|33.3|||<|0.001|TWO_SIDED|95.0|15.6|48.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||48.6|15.6|<0.001
74057142|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|8.9||||0.212|TWO_SIDED|95.0|-3.5|23.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||23.6|-3.5|0.212
74057143|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|18.7||||0.011|TWO_SIDED|95.0|4.8|34.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||34.0|4.8|0.011
74057144|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|4.7||||0.446|TWO_SIDED|95.0|-7.0|19.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||19.1|-7.0|0.446
74057145|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|22.1||||0.003|TWO_SIDED|95.0|7.6|37.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||37.8|7.6|0.003
74057146|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-8.9|9.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||9.7|-8.9|1.000
74057147|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|4.8||||0.317|TWO_SIDED|95.0|-4.1|17.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||17.5|-4.1|0.317
74057148|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|0.8||||1|TWO_SIDED|95.0|-7.2|12.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||12.1|-7.2|1.000
74057149|NCT01050998|147665314|SUPERIORITY_OR_OTHER||Percent difference|9.5||||0.106|TWO_SIDED|95.0|-0.5|23.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||23.5|-0.5|0.106
74057150|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|1.0||||1|TWO_SIDED|95.0|-17.7|20.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||20.4|-17.7|1.000
74057151|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|16.1||||0.12|TWO_SIDED|95.0|-3.1|34.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||34.4|-3.1|0.120
74100897|NCT00711880|147751574|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|29.03||||0.001||95.0|13.39|44.67|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups for each question, using Fisher's Exact Test.||44.67|13.39|0.001
74100898|NCT03417778|147751585|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUClast of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUClast change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|161.14|||||TWO_SIDED|90.0|80.77|321.48||||||An analysis of variance (ANOVA) model was fitted to the natural logarithmic transformed values of the AUClast. Two-sided 90% confidence intervals (CI) were calculated for the geometric least-squares mean (GLSM) ratio of AUClast between hepatic impairment group versus the matched control (normal hepatic function) group.||321.48|80.77|
74057152|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|1.0||||1|TWO_SIDED|95.0|-17.7|20.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||20.4|-17.7|1.000
74057153|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|29.2||||0.005|TWO_SIDED|95.0|9.7|46.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||46.1|9.7|0.005
74057154|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|20.9||||0.382|TWO_SIDED|95.0|-16.4|55.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||55.9|-16.4|0.382
74057155|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|39.0||||0.087|TWO_SIDED|95.0|-2.7|69.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||69.6|-2.7|0.087
74100899|NCT03417778|147751586|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUClast of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUClast change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|122.08|||||TWO_SIDED|90.0|69.67|213.89||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUClast. Two-sided 90% CI were calculated for the GLSM ratio of AUClast between hepatic impairment group versus the matched control (normal hepatic function) group.||213.89|69.67|
74100900|NCT03417778|147751587|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUCinf of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUCinf change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|159.15|||||TWO_SIDED|90.0|82.22|308.06||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUCinf. Two-sided 90% CI were calculated for the GLSM ratio of AUCinf between hepatic impairment group versus the matched control (normal hepatic function) group.||308.06|82.22|
74100901|NCT03417778|147751588|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUCinf of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUCinf change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|122.32|||||TWO_SIDED|90.0|69.9|214.07||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUCinf. Two-sided 90% CI were calculated for the GLSM ratio of AUCinf between hepatic impairment group versus the matched control (normal hepatic function) group.||214.07|69.90|
74100902|NCT03417778|147751589|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for Cmax of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit Cmax change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|115.98|||||TWO_SIDED|90.0|58.75|228.98||||||An ANOVA model was fitted to the natural logarithmic transformed values of the Cmax. Two-sided 90% CI were calculated for the GLSM ratio of Cmax between hepatic impairment group versus the matched control (normal hepatic function) group.||228.98|58.75|
73881727|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.5332|TWO_SIDED|95.0|-1.46|0.76||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.76|-1.46|0.5332
74057156|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-33.7|35.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||35.7|-33.7|1.000
74057157|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|51.5||||0.028|TWO_SIDED|95.0|8.2|77.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||77.0|8.2|0.028
74057158|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|11.1||||0.175|TWO_SIDED|95.0|-2.9|27.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||27.9|-2.9|0.175
74057159|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|17.3||||0.026|TWO_SIDED|95.0|2.4|34.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||34.1|2.4|0.026
74057160|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|8.5||||0.271|TWO_SIDED|95.0|-5.1|24.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||24.9|-5.1|0.271
73881728|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.4599|TWO_SIDED|95.0|-1.54|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.70|-1.54|0.4599
73881729|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.58||0.4752|TWO_SIDED|95.0|-0.72|1.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.55|-0.72|0.4752
74057161|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|18.8||||0.021|TWO_SIDED|95.0|3.4|36.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||36.0|3.4|0.021
74057162|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
74057163|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|25.7||||0.283|TWO_SIDED|95.0|-8.8|63.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||63.2|-8.8|0.283
74057164|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
74057165|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|38.2||||0.059|TWO_SIDED|95.0|1.6|71.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||71.2|1.6|0.059
74057166|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|1.1||||1|TWO_SIDED|95.0|-7.0|14.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||14.2|-7.0|1.000
74057167|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|5.8||||0.242|TWO_SIDED|95.0|-3.7|19.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||19.4|-3.7|0.242
74057168|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|3.7||||0.41|TWO_SIDED|95.0|-5.1|16.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||16.9|-5.1|0.410
74057169|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|13.9||||0.03|TWO_SIDED|95.0|2.7|29.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||29.5|2.7|0.030
74057170|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
74057171|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|0.7||||1|TWO_SIDED|95.0|-26.7|39.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||39.5|-26.7|1.000
74057172|NCT01050998|147665315|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||1|TWO_SIDED|95.0|-37.5|22.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||22.6|-37.5|1.000
74057173|NCT01050998|147665317|SUPERIORITY_OR_OTHER||Adjusted Mean difference|14.05|STANDARD_ERROR_OF_MEAN|7.162||0.051|TWO_SIDED|95.0|-0.05|28.15|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||28.15|-0.05|0.051
74057174|NCT01050998|147665317|SUPERIORITY_OR_OTHER||Adjusted Mean difference|21.23|STANDARD_ERROR_OF_MEAN|7.028||0.003|TWO_SIDED|95.0|7.39|35.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||35.07|7.39|0.003
74057175|NCT01050998|147665317|SUPERIORITY_OR_OTHER||Adjusted Mean difference|7.09|STANDARD_ERROR_OF_MEAN|7.136||0.322|TWO_SIDED|95.0|-6.96|21.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||21.14|-6.96|0.322
74057176|NCT01050998|147665317|SUPERIORITY_OR_OTHER||Adjusted Mean difference|32.03|STANDARD_ERROR_OF_MEAN|7.085|<|0.001|TWO_SIDED|95.0|18.08|45.98|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||45.98|18.08|<0.001
74057177|NCT01050998|147665318|SUPERIORITY_OR_OTHER||Adjusted Mean difference|14.49|STANDARD_ERROR_OF_MEAN|7.981||0.071|TWO_SIDED|95.0|-1.24|30.22|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||30.22|-1.24|0.071
74057178|NCT01050998|147665318|SUPERIORITY_OR_OTHER||Adjusted mean difference|19.43|STANDARD_ERROR_OF_MEAN|7.798||0.013|TWO_SIDED|95.0|4.06|34.8|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||34.80|4.06|0.013
74057179|NCT01050998|147665318|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.84|STANDARD_ERROR_OF_MEAN|7.873||0.32|TWO_SIDED|95.0|-7.68|23.36|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||23.36|-7.68|0.320
74057180|NCT01050998|147665318|SUPERIORITY_OR_OTHER||Adjusted mean difference|31.37|STANDARD_ERROR_OF_MEAN|7.873|<|0.001|TWO_SIDED|95.0|15.85|46.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||46.89|15.85|<0.001
74057181|NCT01050998|147665318|SUPERIORITY_OR_OTHER||Adjusted mean difference|12.11|STANDARD_ERROR_OF_MEAN|17.089||0.483|TWO_SIDED|95.0|-22.41|46.64|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||46.64|-22.41|0.483
74057182|NCT01050998|147665318|SUPERIORITY_OR_OTHER||Adjusted mean difference|31.24|STANDARD_ERROR_OF_MEAN|17.089||0.075|TWO_SIDED|95.0|-3.28|65.77|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||65.77|-3.28|0.075
74057183|NCT01050998|147665318|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.22|STANDARD_ERROR_OF_MEAN|17.872||0.815|TWO_SIDED|95.0|-31.89|40.32|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||40.32|-31.89|0.815
74057184|NCT01050998|147665318|SUPERIORITY_OR_OTHER||Adjusted mean difference|36.11|STANDARD_ERROR_OF_MEAN|17.089||0.041|TWO_SIDED|95.0|1.58|70.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||70.63|1.58|0.041
74057185|NCT00370994|147665348|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Comparisons were made between groups and within the group between baseline and different time points.|Repeated measures ANOVA.|||||||<0.001
74057186|NCT00370994|147665349|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||There were significant differences in Oswestry Disability Index between both groups|Repeated measures of ANOVA|||||||0.001
74057187|NCT00234533|147665364|OTHER|An one-way Analysis of Covariance (ANOVA) was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.9|||||TWO_SIDED|95.0|0.88|0.92|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An Intra-class Correlation Coefficient (ICC) for the evening series (defined as 12:00 to 24:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.||0.92|0.88|
74057188|NCT00234533|147665364|OTHER|An one-way ANOVA was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.92|||||TWO_SIDED|95.0|0.9|0.93|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An ICC for the morning series (defined as 06:00 to 12:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.||0.93|0.90|
74057189|NCT00234533|147665365|OTHER||Fisher's F statistic (F) value|1.79|||||TWO_SIDED|||||||||Analysis of the weekly timing effect (Week 21 versus Week 22 versus Week 23) on the IGF-I value as measured by capillary blood spot method.|For the effect of the weekly timing on the IGF-I levels; F value = 1.79 and the significance probability value, PR\>F = 0.1678.|||
74057190|NCT00234533|147665365|OTHER||F value|1.06|||||TWO_SIDED|||||||||Analysis of the daily timing effect (morning versus evening) on the IGF-I value as measured by capillary blood spot method.|For the effect of the daily timing on the IGF-I levels; F value = 1.06 and the significance probability value, PR\>F = 0.3035|||
74057191|NCT00234533|147665366|OTHER||F value|83.97|||||TWO_SIDED|||||||||Analysis of the effect of the patient's sex (male versus female) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's sex on the IGF-I levels; F value = 83.97 and the significance probability value, PR\>F = \<0.0001.|||
74057192|NCT00234533|147665366|OTHER||F value|68.35|||||TWO_SIDED|||||||||Analysis of the effect of the patient's pubertal status (pubertal versus prepubertal) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's pubertal status on the IGF-I levels; F value = 68.35 and the significance probability value, PR\>F = \<0.0001.|||
74057193|NCT00234533|147665367|OTHER||F value|10.73|||||TWO_SIDED|||||||||Analysis of the disease condition (GHD versus TS) on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 10.73 and the significance probability value, PR\>F = 0.0012.|||
74100903|NCT03417778|147751590|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for Cmax of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit Cmax change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|102.85|||||TWO_SIDED|90.0|60.12|175.98||||||An ANOVA model was fitted to the natural logarithmic transformed values of the Cmax. Two-sided 90% CI were calculated for the GLSM ratio of Cmax between hepatic impairment group versus the matched control (normal hepatic function) group.||175.98|60.12|
74100904|NCT01569295|147751627|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.27|0.45|||Stratified log-rank test||Hazard Ratio is estimated using Cox proportional hazard model, adjusted for randomization stratification factors.|||0.45|0.27|< 0.0001
74100905|NCT01569295|147751628|SUPERIORITY||Odds Ratio (OR)|3.02|||<|0.0001|TWO_SIDED|95.0|1.98|4.62||Odds ratio,p-value and 95% Confidence Interval(CI) were calculated from Cochran-Mantel-Haenszel(CMH) Chi-square test stratified by stratification factor in EDC(del17p/TP53,immunoglobulin heavy chain variable region(IgHV) mutation and disease status).|Cochran-Mantel-Haenszel|||||4.62|1.98|<0.0001
74100906|NCT01569295|147751629|SUPERIORITY||Odds Ratio (OR)|28.81|||<|0.0001|TWO_SIDED|95.0|10.5|79.02||Odds ratio, p-value and 95% CI were calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel|||||79.02|10.50|<0.0001
74100907|NCT01569295|147751630|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.098|TWO_SIDED|95.0|0.59|1.03|||Stratified log-rank test|||||1.03|0.59|0.098
74100908|NCT01569295|147751631|SUPERIORITY||Odds Ratio (OR)|9.55||||0.011|TWO_SIDED|95.0|1.19|76.81||Odds ratio, 95% CI and p-value are calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel|||||76.81|1.19|0.011
74100909|NCT03852537|147751650|SUPERIORITY|||||||0.494|||||||Fisher Exact|||||||0.494
74100910|NCT03852537|147751651|SUPERIORITY|||||||0.666|||||||Fisher Exact|||||||0.666
74100911|NCT03852537|147751652|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
74100912|NCT03852537|147751654|SUPERIORITY|||||||0.477|||||||Fisher Exact|||||||0.477
74100913|NCT03852537|147751655|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.000
74057194|NCT00234533|147665367|OTHER||F value|2.2|||||TWO_SIDED|||||||||Analysis of the country cluster on the IGF-I value as measured by capillary blood spot method.|For the effect of the country cluster on the IGF-I levels; F value = 2.20 and the significance probability value, PR\>F = 0.0701.|||
74057195|NCT00234533|147665368|OTHER||F value|3.65|||||TWO_SIDED|||||||||Analysis of the time of the year on the IGF-I value as measured by capillary blood spot method.|For the effect of the time of the year on the IGF-I levels; F value = 3.65 and the significance probability value, PR\>F = 0.0139.|||
74057196|NCT00234533|147665368|OTHER||F value|7.38|||||TWO_SIDED|||||||||Analysis of the effect of the calculated age at enrolment on the IGF-I value as measured by capillary blood spot method.|For the effect of the calculated age at enrolment on the IGF-I levels; F value = 7.38 and the significance probability value, PR\>F = 0.0073.|||
74057197|NCT00234533|147665368|OTHER||F value|3.86|||||TWO_SIDED|||||||||Analysis of the effect of the disease condition on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 3.86 and the significance probability value, PR\>F = 0.0511|||
74057198|NCT00234533|147665369|OTHER||Mean difference|-164.79|STANDARD_ERROR_OF_MEAN|159.28|||TWO_SIDED|95.0|-483.35|-153.77||||||The Bland and Altman method was used to compare the results of each of the three simultaneous random capillary and serum measurements were compared. The difference between the capillary blood spot method and the serum IGF-I measurements is presented||-153.77|-483.35|
74057199|NCT00736840|147665427|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Provided above|Sensitivity|0.74|STANDARD_ERROR_OF_MEAN|0.0363||0.0924|TWO_SIDED|95.0|0.6607|0.8809|||Exact binomial test|||The null hypothesis was sensitivity lower than 0.8. We assumed a sensitivity of 0.89 and required a power of 90% to test the hypothesis at a 5% level of significance, and calculated that 173 cirrhotic and 241 non-cirrhotic subjects were needed (for a one-sample binomial test of outcome versus constant).||0.8809|0.6607|0.0924
74057200|NCT00736840|147665428|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size was calculated to enable the testing of both study hypotheses (together) with at least 80% power. Our best estimate of sensitivity of the HIS diagnosis in the population, was 0.9 and its specificity 0.79. Requiring a power of 90% for each of the hypotheses and a 5% level of significance, to test the null hypotheses 173 cirrhotic and 241 non-cirrhotic subjects were needed.Therefore a total of at least 414 subjects were required.|AUC ROC|0.785|STANDARD_ERROR_OF_MEAN|0.0485|<|0.0001|TWO_SIDED|95.0|0.737|0.834|||Regression, Logistic|||||0.834|0.737|<0.0001
74057201|NCT03289676|147665443|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
74057202|NCT03289676|147665445|OTHER||Odds Ratio, log|1.12||||0.029|TWO_SIDED|95.0|1.0|1.24|||Regression, Logistic|||||1.24|1.00|0.029
74057203|NCT01314261|147665446|SUPERIORITY_OR_OTHER|||||||0.336|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV subgenotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.336
74100914|NCT03852537|147751656|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
74100915|NCT03852537|147751657|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
74100916|NCT03852537|147751658|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
74100917|NCT03852537|147751660|SUPERIORITY|||||||0.213|||||||Chi-squared|||||||0.213
74057204|NCT01314261|147665446|SUPERIORITY_OR_OTHER|||||||0.171|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.171
74057205|NCT01314261|147665446|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.030
74057206|NCT01314261|147665447|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.102
74057207|NCT01314261|147665447|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.362
74057208|NCT01314261|147665447|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.079
74057209|NCT01314261|147665451|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.083
74057210|NCT01314261|147665451|SUPERIORITY_OR_OTHER|||||||0.515|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.515
74057211|NCT01314261|147665451|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.221
74057212|NCT01314261|147665452|SUPERIORITY_OR_OTHER|||||||0.155|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.155
74057213|NCT01314261|147665452|SUPERIORITY_OR_OTHER|||||||0.214|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.214
74057214|NCT01314261|147665452|SUPERIORITY_OR_OTHER|||||||0.231|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.231
74057215|NCT01314261|147665453|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.127
74057216|NCT01314261|147665453|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.328
74057217|NCT01314261|147665453|SUPERIORITY_OR_OTHER|||||||0.166|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.166
74057218|NCT01314261|147665454|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.007
74057219|NCT01314261|147665454|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.029
74057220|NCT01314261|147665454|SUPERIORITY_OR_OTHER|||||||0.105|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.105
74057221|NCT01314261|147665457|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.028
74057222|NCT01314261|147665457|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.051
74057223|NCT01314261|147665457|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.021
74057224|NCT00412360|147665460|SUPERIORITY|||||||0.17||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in overall survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant. The targeted sample size of 110 participants per treatment group was sufficient to maintain a type I error rate of 5% and provide more than 86% power to detect an increase in overall survival from 57% among participants receiving a single unit graft to 77% for those receiving a double-unit graft.||||0.17
74057225|NCT00412360|147665461|SUPERIORITY|||||||0.11||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in disease-free survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant.||||0.11
74057226|NCT00412360|147665462|SUPERIORITY|||||||0.29||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment between participants receiving single- and double-unit cord blood transplant.||||0.29
74057227|NCT00412360|147665462|SUPERIORITY|||||||0.04||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment between participants receiving single- and double-unit cord blood transplant.||||0.04
74057228|NCT00412360|147665464|SUPERIORITY|||||||0.78||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade II-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.||||0.78
74057229|NCT00412360|147665464|SUPERIORITY|||||||0.02||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade III-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.||||0.02
74057230|NCT00412360|147665465|SUPERIORITY|||||||0.51||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD between participants receiving single- and double-unit cord blood transplant.||||0.51
74057231|NCT00412360|147665465|SUPERIORITY|||||||0.05||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of extensive chronic GVHD between participants receiving single- and double-unit cord blood transplant.||||0.05
74100918|NCT03901092|147751691|OTHER||Fleiss' kappa|0.87|||||TWO_SIDED|95.0|0.83|0.91||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The primary hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.91|0.83|
74057232|NCT00412360|147665467|SUPERIORITY|||||||0.12||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of relapse between participants receiving single- and double-unit cord blood transplant.||||0.12
74057233|NCT00412360|147665468|SUPERIORITY|||||||0.43||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality between participants receiving single- and double-unit cord blood transplant.||||0.43
74057234|NCT00422227|147665515|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
74057235|NCT00422227|147665516|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||ACR 20||||<0.001
74057236|NCT00422227|147665516|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||ACR 50||||<0.001
74057237|NCT00422227|147665516|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Fisher Exact|||ACR 70||||0.009
74057238|NCT00422227|147665517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||Low Disease (DAS28 \<3.2)||||<0.001
74057239|NCT00422227|147665517|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Fisher Exact|||Remission (DAS28 \<2.6)||||0.069
74057240|NCT00422227|147665518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74057241|NCT00422227|147665519|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
74057242|NCT00422227|147665520|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||≥0.6||||0.003
74057243|NCT00422227|147665520|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||≥1.2||||0.001
74057244|NCT00422227|147665521|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||ANCOVA|||Painful Joints at Week 16||||0.014
74057245|NCT00422227|147665521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Swollen Joints at Week 16||||<0.001
74057246|NCT00422227|147665522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Physician Global Assessment Week 16||||<0.001
74057247|NCT00422227|147665522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Subject Global Assessment Week 16||||<0.001
74057248|NCT00422227|147665523|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Week 16||||<0.001
74057249|NCT00422227|147665524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||General Health Week 16||||<0.001
74057250|NCT00422227|147665524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Pain Week 16||||<0.001
74057251|NCT00422227|147665524|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Fatigue Week 16||||0.001
74057252|NCT01798056|147665526|NON_INFERIORITY|Criteria used: The lower limit (LL) of the 95% confidence interval (CI) of the Geometric Mean (GM) ratio (GSK1437173A PreChemo group over Placebo PreChemo group) in anti-gE ELISA antibody concentrations is greater than 3.|Adjusted GMC ratio|23.2|||||TWO_SIDED|95.0|17.9|30.0||||Difference of means between vaccines and placebo were calculated together with 2-sided confidence intervals and back-transformed to the original units||The analysis evaluated the anti-gE humoral immune responses at Month 2, following a two-dose administration of the GSK1437173A vaccine, as compared to placebo in subjects with solid tumours receiving chemotherapy (PreChemo Groups only).||30|17.9|
74057253|NCT02646566|147665590|SUPERIORITY|||||||0.003||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.003) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.003
74057254|NCT02646566|147665590|SUPERIORITY|||||||0.109||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.109) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.109
74057255|NCT02646566|147665591|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
74057256|NCT02646566|147665591|SUPERIORITY|||||||0.059||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.059
74057257|NCT02646566|147665592|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
74057258|NCT02646566|147665592|SUPERIORITY|||||||0.053||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.053
74057259|NCT02646566|147665593|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
74057260|NCT02646566|147665593|SUPERIORITY|||||||0.021||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.021
74057261|NCT02646566|147665594|SUPERIORITY||||||<|0.001|||||||Regression, Cox|||||||<0.001
74057262|NCT02646566|147665594|SUPERIORITY|||||||0.084|||||||Regression, Cox|||||||0.084
74057263|NCT02646566|147665595|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74057264|NCT02646566|147665595|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
74057265|NCT02646566|147665596|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
74057266|NCT02646566|147665596|SUPERIORITY|||||||0.179|||||||Chi-squared|||||||0.179
74057267|NCT02646566|147665597|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
74057268|NCT02646566|147665597|SUPERIORITY|||||||0.315|||||||Chi-squared|||||||0.315
74057269|NCT02646566|147665598|SUPERIORITY|||||||0.065|||||||Chi-squared|||||||0.065
74057270|NCT02646566|147665598|SUPERIORITY|||||||0.52|||||||Chi-squared|||||||0.520
74057271|NCT02646566|147665599|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
74057272|NCT02646566|147665599|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
74057273|NCT02646566|147665600|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74057274|NCT02646566|147665600|SUPERIORITY|||||||0.258|||||||Wilcoxon (Mann-Whitney)|||||||0.258
74057275|NCT02222246|147665607|NON_INFERIORITY|Change in pain scores from arrival to discharge||||||0.0311|||||||Mixed Models Analysis|Analysis for pain change was conducted using Hierarchical Linear Mixed Effects Model (HLM), adjusting for nested patient and site effects (N=126)||||||0.0311
74057276|NCT02222246|147665608|NON_INFERIORITY|Trajectory of pain across time (arrival to discharge)||||||0.0049||||||p-value for the protocol by time interaction|Mixed Models Analysis|||The trajectory of change in pain score was evaluated every 30 minutes over 120 hours (2 hours) rather than 6 hours because of expected missing data after 120 minutes due to discharge from the ED.||||0.0049
74057277|NCT02222246|147665608|NON_INFERIORITY|Emergency Department Arrival||||||0.9393|||||||t-test, 2 sided|||||||0.9393
74057278|NCT02222246|147665608|NON_INFERIORITY|Post-placement 30 minutes||||||0.7259|||||||t-test, 2 sided|||||||0.7259
74057279|NCT02222246|147665608|NON_INFERIORITY|Post-placement 60 minutes||||||0.53|||||||t-test, 2 sided|||||||0.5300
74057280|NCT02222246|147665608|NON_INFERIORITY|Post-placement 90 minutes||||||0.3678|||||||t-test, 2 sided|||||||0.3678
74057281|NCT02222246|147665608|NON_INFERIORITY|Post-placement 120 minutes||||||0.2457|||||||t-test, 2 sided|||||||0.2457
74057282|NCT02222246|147665608|NON_INFERIORITY|Emergency Department Discharge||||||0.0007|||||||t-test, 2 sided|||||||0.0007
74057283|NCT02222246|147665609|NON_INFERIORITY|Incidence of nausea during Emergency Department Visit - YES||||||0.0001|||||||Chi-squared|||||||0.0001
74057284|NCT02222246|147665610|NON_INFERIORITY|Incidence of vomiting (YES) during Emergency Department visit||||||0.6625|||||||Chi-squared|||||||0.6625
74057285|NCT02222246|147665611|NON_INFERIORITY|Decrease in systolic BP (\>= 20% of baseline)||||||0.4473|||||||Chi-squared|||||||0.4473
74057286|NCT02222246|147665612|NON_INFERIORITY|Decrease in diastolic blood pressure (\>= 20% baseline)||||||0.5372|||||||Chi-squared|||||||0.5372
74057287|NCT02222246|147665613|NON_INFERIORITY|Incidence of oxygen desaturation (\<95%) YES during Emergency Department visit||||||0.2891|||||||Chi-squared|||||||0.2891
74057288|NCT02222246|147665615|NON_INFERIORITY|Incidence of sedation during Emergency Department visit.||||||0.3915|||||||Chi-squared|||||||0.3915
74057289|NCT02222246|147665616|NON_INFERIORITY|Incidence of the need for supplemental oxygen during Emergency Department visit||||||0.0726|||||||Chi-squared|||||||0.0726
74057290|NCT02660489|147665619|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
74057291|NCT02660489|147665620|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
74057292|NCT02660489|147665621|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
74057293|NCT02660489|147665622|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
74057294|NCT02660489|147665623|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
74057295|NCT02660489|147665624|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
74057296|NCT02660489|147665625|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
74057297|NCT02660489|147665626|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
74100919|NCT03901092|147751694|OTHER||Fleiss' kappa|0.84|||||TWO_SIDED|95.0|0.8|0.88||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The primary hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.88|0.80|
74057298|NCT02652793|147665633|SUPERIORITY|Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in lumbar spine BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.03||0.0239|TWO_SIDED|95.0|0.001|0.019||Statistical test applied to lumbar spine BMD only. P-value reflects within-group change from baseline to Week 48.|Regression, Linear|Per-protocol analysis; missing data excluded|Represents mean change in lumbar spine BMD from baseline to Week 48.|Single-arm study; no comparator group||0.019|0.001|0.0239
74100920|NCT03901092|147751695|OTHER||Fleiss' kappa|0.9|||||TWO_SIDED|95.0|0.85|0.95||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.95|0.85|
74100921|NCT03901092|147751696|OTHER||Cohen's kappa|0.89|||||TWO_SIDED|95.0|0.69|1.0||||||Cohen's kappa statistic for Reader 1||1.00|0.69|
74100922|NCT03901092|147751696|OTHER||Cohen's kappa|0.71|||||TWO_SIDED|95.0|0.41|1.0||||||Cohen's kappa statistic for Reader 2||1.00|0.41|
74100923|NCT03901092|147751696|OTHER||Cohen's kappa|0.6|||||TWO_SIDED|95.0|0.24|0.95||||||Cohen's kappa statistic for Reader 3||0.95|0.24|
74100924|NCT03901092|147751696|OTHER||Cohen's kappa|0.89|||||TWO_SIDED|95.0|0.67|1.0||||||Cohen's kappa statistic for Reader 4||1.00|0.67|
74100925|NCT03901092|147751696|OTHER||Cohen's kappa|0.79|||||TWO_SIDED|95.0|0.52|1.0||||||Cohen's kappa statistic for Reader 5||1.00|0.52|
74100926|NCT00396565|147751733|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.7|STANDARD_ERROR_OF_MEAN|2.26|<|0.0001||95.0|-17.16|-8.25|||ANCOVA|ANCOVA model with treatment as a factor and baseline score as a covariate||||-8.25|-17.16|<0.0001
74100927|NCT00396565|147751734|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001||95.0|-5.17|-2.51|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate.||||-2.51|-5.17|<0.0001
74100928|NCT00396565|147751735|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-3.71|-1.33|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate||||-1.33|-3.71|<0.0001
74100929|NCT00396565|147751736|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.21|<|0.0001||95.0|-8.58|-3.8|||ANCOVA|ANCOVA model with treatment as a factor, and with baseline score as a covariate||||-3.80|-8.58|<0.0001
74100930|NCT00396565|147751737|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Fisher Exact|||||||0.0007
74100931|NCT00396565|147751738|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.84|-0.34|||ANCOVA|ANCOVA model with treatment as a factor, and baseline score as a covariate||||-0.34|-0.84|<0.0001
73881730|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.58||0.9051|TWO_SIDED|95.0|-1.21|1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.07|-1.21|0.9051
74100932|NCT01252277|147751740|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p\<0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
74100933|NCT01252277|147751741|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.021
74100934|NCT01252277|147751742|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
74100935|NCT01252277|147751743|SUPERIORITY_OR_OTHER|||||||0.48||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.48
74100936|NCT03097991|147751776|SUPERIORITY||Slope|1.86|STANDARD_ERROR_OF_MEAN|1.86||0.32|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.32
74100937|NCT03097991|147751776|SUPERIORITY||Slope|-0.84|STANDARD_ERROR_OF_MEAN|1.33||0.53|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.53
74100938|NCT03097991|147751777|SUPERIORITY||Slope|-3.04|STANDARD_ERROR_OF_MEAN|1.63||0.07|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.07
74100939|NCT03097991|147751777|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.36||0.69|TWO_SIDED||||||Mixed Models Analysis||||Group Effect|||.69
74100940|NCT03097991|147751778|SUPERIORITY||Slope|2.44|STANDARD_ERROR_OF_MEAN|2.0||0.22|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.22
74100941|NCT03097991|147751778|SUPERIORITY||Slope|0.84|STANDARD_ERROR_OF_MEAN|1.33||0.53|TWO_SIDED||||||Mixed Models Analysis||Group effect|||||.53
74100942|NCT03097991|147751779|SUPERIORITY||Slope|-1.73|STANDARD_ERROR_OF_MEAN|1.76||0.33|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.33
74100943|NCT03097991|147751779|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.36||0.69|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.69
74100944|NCT03097991|147751780|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.81|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.81
74100945|NCT03097991|147751780|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.56|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.56
74100946|NCT03097991|147751781|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.77|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.77
74100947|NCT03097991|147751781|SUPERIORITY||Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.85
74100948|NCT03097991|147751782|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.56|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.56
74100949|NCT03097991|147751782|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.81|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.81
74100950|NCT03097991|147751783|SUPERIORITY||Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint effect|||||.85
74057299|NCT02652793|147665633|SUPERIORITY|Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in left hip BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.|Mean Difference (Final Values)|0.013|STANDARD_DEVIATION|0.03||0.0046|TWO_SIDED|95.0|0.004|0.023||Left hip|Regression, Linear|Statistical test applied to left hip BMD only. P-value reflects within-group change from baseline to Week 48.|Represents mean change in left hip BMD from baseline to Week 48|Single-arm study; no comparator group||0.023|0.004|0.0046
74057300|NCT00830310|147665662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||<0.001
74057301|NCT00830310|147665663|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.002
74057302|NCT00830310|147665664|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.001
74057303|NCT00830310|147665665|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.001
74057304|NCT00830310|147665666|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.001
74057305|NCT00830310|147665667|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.011
74057306|NCT00830310|147665668|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.038
74057307|NCT00830310|147665669|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.002
74057308|NCT00830310|147665670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<0.001
74057309|NCT00634933|147665671|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test (CMH), stratified by prior anti-tumor necrosis factor (anti-TNF) use and geographic region, was used.||||0.061
74057310|NCT00634933|147665671|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.120
74057311|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.570
74057312|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.200
74057313|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.616
74057314|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.671
74057315|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.108
74100951|NCT03097991|147751783|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.77|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.77
74100952|NCT03097991|147751784|SUPERIORITY||Slope|21.01|STANDARD_ERROR_OF_MEAN|5.91|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||<.001
74100953|NCT03097991|147751784|SUPERIORITY||Slope|2.98|STANDARD_ERROR_OF_MEAN|4.75|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group|||||<.001
74057316|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.174
74057317|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.010
74057318|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.029
74057319|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.006
74057320|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.021
74057321|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.062
74057322|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.049
74057323|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.030
74057324|NCT00634933|147665672|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.005
74057325|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.014
74057326|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.025
74057327|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.794|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.794
74057328|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.966|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.966
74100954|NCT03097991|147751785|SUPERIORITY||Slope|0.68|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED||||||Mixed Models Analysis|linear mixed effects|Group|||||<.05
74100955|NCT03097991|147751785|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.6|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||<.05
74057329|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.770
74057330|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.456|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.456
74057331|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.880
74057332|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.814
74057333|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.042
74057334|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.035
74057335|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.086
74057336|NCT00634933|147665673|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.082
74057337|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.325
74100956|NCT03097991|147751786|SUPERIORITY||Slope|3.52|STANDARD_ERROR_OF_MEAN|4.14||0.39|TWO_SIDED||||||Mixed Models Analysis||Group|"We analyzed the CTS scales Psychological Aggression and Physical Assault. Inspection of the latter in the raw data and descriptives showed extremely consistent selection of the lowest value of the scale (no incidents of assault) across all respondents, so we did not conduct inferential tests."||||.39
74100957|NCT03097991|147751786|SUPERIORITY||Slope|-13.38|STANDARD_ERROR_OF_MEAN|4.86|<|0.005|TWO_SIDED||||||Mixed Models Analysis||Group x Time|||||<.005
74057338|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.338|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.338
74057339|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.983|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.983
74057340|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.296
74057341|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.575|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.575
74057342|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||1.000
74057343|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.573
74057344|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.563|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.563
74100958|NCT03097991|147751787|SUPERIORITY||Slope|-1.17|STANDARD_ERROR_OF_MEAN|1.25||0.24|TWO_SIDED||||||Mixed Models Analysis||Group|||||.24
74100959|NCT03097991|147751787|EQUIVALENCE|ANOVA found a main effect of group, F(1, 155) = 6.85, p \< .05, η2G = .04.|Mean Difference (Final Values)|6.85|||<|0.05|TWO_SIDED||||||ANOVA||Group|||||<.05
74057345|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.768
74057346|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.977
74057347|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.249|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.249
74057348|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.268
74057349|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.089
74057350|NCT00634933|147665674|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.079
74057351|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.106
74057352|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.322|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.322
74057353|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4 Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.059
74057354|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.250
74057355|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.255|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.255
74057356|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.105|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.105
74057357|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.001
74100960|NCT03097991|147751788|SUPERIORITY||Slope|-2.53|STANDARD_ERROR_OF_MEAN|1.04||0.02|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.02
74100961|NCT03097991|147751788|SUPERIORITY||Slope|0.45|STANDARD_ERROR_OF_MEAN|0.78||0.56|TWO_SIDED||||||Mixed Models Analysis||Group|||||.56
74057358|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.019
74057359|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.011
74100962|NCT03097991|147751789|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|0.9||0.3|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.30
74057360|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.113
74057361|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.002
74057362|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.006
74057363|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.034
74057364|NCT00634933|147665689|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.003
74057365|NCT01694849|147665701|SUPERIORITY||Odds Ratio (OR)|1.092||||0.8539|TWO_SIDED|95.0|0.427|2.795||To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.|Regression, Logistic|Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values|Standard error of the estimate|H\_01: OR\_80 less than or equal to 1 versus H\_11 : OR\_80 greater than 1 H\_02: OR\_120 less than or equal to 1 versus H\_12 : OR\_120 greater than 1||2.795|0.427|0.8539
74057366|NCT01694849|147665701|SUPERIORITY||Odds Ratio (OR)|0.897||||0.816|TWO_SIDED|95.0|0.361|2.232||To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.|Regression, Logistic|Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values|Standard error of the estimate|H\_01: OR\_80 less than or equal to 1 versus H\_11 : OR\_80 greater than 1 H\_02: OR\_120 less than or equal to 1 versus H\_12 : OR\_120 greater than 1||2.232|0.361|0.8160
74057367|NCT01694849|147665702|SUPERIORITY||difference in least square mean change|-0.27||||0.225|TWO_SIDED|95.0|-0.75|0.2|||Mixed Models Analysis|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the least squares mean|"H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0~Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4"||0.2|-0.75|0.225
74057368|NCT01694849|147665702|SUPERIORITY||Difference in least square mean change|-0.28||||0.254|TWO_SIDED|95.0|-0.76|0.2|||Mixed Models Analysis|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the least squares mean|"H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0~Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4"||0.2|-0.76|0.254
74057369|NCT01694849|147665703|SUPERIORITY||Odds Ratio (OR)|1.073||||0.8586|TWO_SIDED|95.0|0.493|2.339|||Regression, Logistic|Baseline Non-Alcoholic Fatty Liver Disease Activity Score.|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.339|0.493|0.8586
74057370|NCT01694849|147665703|SUPERIORITY||Odds Ratio (OR)|1.601||||0.2265|TWO_SIDED|95.0|0.747|3.432|||Regression, Logistic|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||3.432|0.747|0.2265
74057371|NCT01694849|147665704|SUPERIORITY||Odds Ratio (OR)|0.723||||0.5231|TWO_SIDED|95.0|0.267|1.958|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.958|0.267|0.5231
74057372|NCT01694849|147665704|SUPERIORITY||Odds Ratio (OR)|1.102||||0.8459|TWO_SIDED|95.0|0.415|2.924|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.924|0.415|0.8459
74057373|NCT01694849|147665705|SUPERIORITY||Odds Ratio (OR)|0.638||||0.5229|TWO_SIDED|95.0|0.161|2.529|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.529|0.161|0.5229
74057374|NCT01694849|147665705|SUPERIORITY||Odds Ratio (OR)|1.433||||0.5646|TWO_SIDED|95.0|0.421|4.875|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||4.875|.421|0.5646
74057375|NCT01694849|147665706|SUPERIORITY||Odds Ratio (OR)|0.382||||0.1983|TWO_SIDED|95.0|0.088|1.656|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.656|0.088|0.1983
74057376|NCT01694849|147665706|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.288|3.466|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||3.466|0.288|1.0000
74100963|NCT03097991|147751789|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.67||0.36|TWO_SIDED||||||Mixed Models Analysis||Group|||||.36
74100964|NCT03097991|147751790|SUPERIORITY||Slope|-0.75|STANDARD_ERROR_OF_MEAN|0.55||0.17|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.17
74100965|NCT03097991|147751790|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.48|TWO_SIDED||||||Mixed Models Analysis||Group|||||.48
74100966|NCT03097991|147751791|SUPERIORITY||Slope|1.15|STANDARD_ERROR_OF_MEAN|7.34||0.88|TWO_SIDED||||||Mixed Models Analysis||Group|||||.88
74100967|NCT03097991|147751791|SUPERIORITY||Slope|7.94|STANDARD_ERROR_OF_MEAN|9.0||0.38|TWO_SIDED||||||Mixed Models Analysis||Group x Time|||||.38
74057377|NCT01694849|147665707|SUPERIORITY||Odds Ratio (OR)|0.653||||0.3543|TWO_SIDED|95.0|0.265|1.609|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.609|0.265|0.3543
74057378|NCT01694849|147665707|SUPERIORITY||Odds Ratio (OR)|1.27||||0.578|TWO_SIDED|95.0|0.547|2.953|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.953|0.547|0.5780
74057379|NCT01694849|147665708|SUPERIORITY||Difference in least square mean change|1.24||||0.711|TWO_SIDED|95.0|-5.33|7.81|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in aspartate transaminase (U/L)||7.81|-5.33|0.711
74057380|NCT01694849|147665708|SUPERIORITY||Difference in least square mean change|-0.94||||0.78|TWO_SIDED|95.0|-7.58|5.7|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in aspartate transaminase (U/L)||5.7|-7.58|0.78
74057381|NCT01694849|147665708|SUPERIORITY||Difference in least square mean change|-6.13||||0.221|TWO_SIDED|95.0|-15.97|3.71|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in alanine aminotransferase (U/L)||3.71|-15.97|0.221
74057382|NCT01694849|147665708|SUPERIORITY||Difference in least square mean change|-9.45||||0.062|TWO_SIDED|95.0|-19.4|0.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in alanine aminotransferase (U/L)||0.49|-19.4|0.062
74057383|NCT01694849|147665708|SUPERIORITY||Difference in least square mean change|-23.02|||<|0.001|TWO_SIDED|95.0|-27.16|-18.88|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Alkaline phosphatases (U/L)||-18.88|-27.16|<0.001
74057384|NCT01694849|147665708|SUPERIORITY||Difference in least square mean change|-23.85|||<|0.001|TWO_SIDED|95.0|-28.04|2.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Alkaline phosphatases (U/L)||2.12|-28.04|<0.001
74057385|NCT01694849|147665708|SUPERIORITY||Difference in least square mean change|-31.41|||<|0.001|TWO_SIDED|95.0|-43.78|-19.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Gamma-glutamyl transferase (U/L)||-19.05|-43.78|<0.001
74057386|NCT01694849|147665708|SUPERIORITY||Difference in least square mean change|-29.31|||<|0.001|TWO_SIDED|95.0|-41.84|-16.77|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Gamma-glutamyl transferase (U/L)||-16.77|-41.84|<0.001
74057387|NCT01694849|147665709|SUPERIORITY||Difference in least square mean change|0.14|||<|0.001|TWO_SIDED|95.0|0.06|0.21|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.21|0.06|<0.001
74100968|NCT03097991|147751792|SUPERIORITY||Slope|-1.89|STANDARD_ERROR_OF_MEAN|1.05||0.07|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.07
74100969|NCT03097991|147751792|SUPERIORITY||Slope|2.52|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group|||||<.001
74100970|NCT03097991|147751793|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.38||0.92|TWO_SIDED||||||Mixed Models Analysis||Group|||||.92
73881731|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.58||0.9937|TWO_SIDED|95.0|-1.14|1.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.15|-1.14|0.9937
74057388|NCT01694849|147665709|SUPERIORITY||Difference in least square mean change|0.19|||<|0.001|TWO_SIDED|95.0|0.11|0.26|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.26|0.11|<0.001
74057389|NCT01694849|147665710|SUPERIORITY||Difference in least square mean change|141.78||||0.095|TWO_SIDED|95.0|-24.99|308.55|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||308.55|-24.99|0.095
74057390|NCT01694849|147665710|SUPERIORITY||Difference in least square mean change|-70.57||||0.412|TWO_SIDED|95.0|-239.85|98.71||Baseline parameter value and presence of diabetes as random factors|Mixed Models Analysis||Standard error of the least square mean|||98.71|-239.85|0.412
74057391|NCT01694849|147665711|SUPERIORITY||Difference in least square mean change|32.39||||0.592|TWO_SIDED|95.0|-86.63|151.42|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||151.42|-86.63|0.592
74057392|NCT01694849|147665711|SUPERIORITY||Difference in least square mean change|31.35||||0.61|TWO_SIDED|95.0|-89.42|152.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||152.12|-89.42|0.61
74100971|NCT03097991|147751793|SUPERIORITY||Slope|1.12|STANDARD_ERROR_OF_MEAN|0.57||0.05|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.05
74100972|NCT03097991|147751794|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.47||0.81|TWO_SIDED||||||Mixed Models Analysis||Group|||||.81
74100973|NCT03097991|147751794|SUPERIORITY||Slope|-0.67|STANDARD_ERROR_OF_MEAN|0.7||0.34|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.34
73881732|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.57||0.6956|TWO_SIDED|95.0|-0.91|1.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.35|-0.91|0.6956
73888194|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.4224|TWO_SIDED|95.0|-7.6|18.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-7.6|0.4224
74100974|NCT03097991|147751795|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.76|TWO_SIDED||||||Mixed Models Analysis||Group|||||.76
74100975|NCT03097991|147751795|SUPERIORITY||Slope|0.31|STANDARD_ERROR_OF_MEAN|0.49||0.53|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.53
74100976|NCT03097991|147751796|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.88|TWO_SIDED||||||Mixed Models Analysis||Group|||||.88
74057393|NCT01694849|147665712|SUPERIORITY||Difference in least square mean change|1.67||||0.459|TWO_SIDED|95.0|-2.77|6.11|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||6.11|-2.77|0.459
74057394|NCT01694849|147665712|SUPERIORITY||Difference in least square mean change|-0.67||||0.764|TWO_SIDED|95.0|-5.06|3.72|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.72|-5.06|0.764
74057395|NCT01694849|147665713|SUPERIORITY||Difference in least square mean change|-12.92||||0.466|TWO_SIDED|95.0|-47.79|21.95|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||21.95|-47.79|0.466
74057396|NCT01694849|147665713|SUPERIORITY||Difference in least square mean change|-5.82||||0.745|TWO_SIDED|95.0|-41.07|29.42|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||29.42|-41.07|0.745
74057397|NCT01694849|147665714|SUPERIORITY||Difference in least square mean change|-26.57||||0.018|TWO_SIDED|95.0|-48.59|-4.54|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG19||-4.54|-48.59|0.018
74057398|NCT01694849|147665714|SUPERIORITY||Difference in least square mean change|-40.39|||<|0.001|TWO_SIDED|95.0|-62.61|-18.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG19||-18.17|-62.61|<0.001
74057399|NCT01694849|147665714|SUPERIORITY||Difference in least square mean change|190.07||||0.101|TWO_SIDED|95.0|-37.38|417.52|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG21||417.52|-37.38|0.101
74057400|NCT01694849|147665714|SUPERIORITY||Difference in least square mean change|228.33||||0.052|TWO_SIDED|95.0|-2.16|458.82|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG21||458.82|-2.16|0.052
74057401|NCT01694849|147665715|SUPERIORITY||Difference in least square mean change|-0.14||||0.002|TWO_SIDED|95.0|-0.29|-0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.01|-0.29|0.002
74057402|NCT01694849|147665715|SUPERIORITY||Difference in least square mean change|-0.24|||<|0.001|TWO_SIDED|95.0|-0.34|-0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.15|-0.34|<0.001
74057403|NCT01694849|147665716|SUPERIORITY||Difference in least square mean change|-16.54||||0.203|TWO_SIDED|95.0|-42.07|8.98|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Hyaluronic acid||8.98|-42.07|0.203
74057404|NCT01694849|147665716|SUPERIORITY||Difference in least square mean change|-6.79||||0.603|TWO_SIDED|95.0|-32.49|18.9|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||18.9|-32.49|0.603
74057405|NCT01694849|147665716|SUPERIORITY||Difference in least square mean change|-0.73||||0.235|TWO_SIDED|95.0|-1.95|0.48|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|PIIINP||0.48|-1.95|0.235
74057406|NCT01694849|147665716|SUPERIORITY||Difference in least square mean change|-0.81||||0.193|TWO_SIDED|95.0|-2.04|0.41|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|PIIINP||0.41|-2.04|0.193
74057407|NCT01694849|147665716|SUPERIORITY||Difference in least square mean change|6.21||||0.348|TWO_SIDED|95.0|-6.81|19.22|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|TIMP-1||19.22|-6.81|0.348
74057408|NCT01694849|147665716|SUPERIORITY||Difference in least square mean change|-14.66||||0.029|TWO_SIDED|95.0|-27.81|1.51|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|TIMP-1||1.51|-27.81|0.029
74057409|NCT01694849|147665717|SUPERIORITY||Difference in least square mean change|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.02|-0.07|<0.001
74057410|NCT01694849|147665717|SUPERIORITY||Difference in least square mean change|-0.05|||<|0.001|TWO_SIDED|95.0|-0.08|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.02|-0.08|<0.001
74057411|NCT01694849|147665718|SUPERIORITY||Difference in least square mean change|-0.11|||<|0.001|TWO_SIDED|95.0|-0.15|-0.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.07|-0.15|<0.001
74057412|NCT01694849|147665718|SUPERIORITY||Difference in least square mean change|-0.11|||<|0.001|TWO_SIDED|95.0|-0.15|-0.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.07|-0.15|<0.001
74057413|NCT01694849|147665719|SUPERIORITY||Difference in least square mean change|0.06||||0.471|TWO_SIDED|95.0|-0.11|0.23|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.23|-0.11|0.471
74057414|NCT01694849|147665719|SUPERIORITY||Difference in least square mean change|-0.25||||0.005|TWO_SIDED|95.0|-0.42|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.08|-0.42|0.005
74057415|NCT01694849|147665720|SUPERIORITY||Difference in least square mean change|-0.07||||0.457|TWO_SIDED|95.0|-0.27|0.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.12|-0.27|0.457
74100977|NCT03097991|147751796|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.95
74057416|NCT01694849|147665720|SUPERIORITY||Difference in least square mean|-0.08||||0.428|TWO_SIDED|95.0|-0.28|0.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.12|-0.28|0.428
74100978|NCT03097991|147751797|SUPERIORITY||Slope|0.82|STANDARD_ERROR_OF_MEAN|1.13||0.47|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.47
74100979|NCT03097991|147751797|SUPERIORITY||Slope|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.07|TWO_SIDED||||||Mixed Models Analysis||Group|||||.07
74100980|NCT03097991|147751798|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.32||0.68|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.68
74057417|NCT01694849|147665721|SUPERIORITY||Difference in least square mean change|-9.22|||<|0.001|TWO_SIDED|95.0|-13.19|-5.24|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-5.24|-13.19|<0.001
73881733|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.2302|TWO_SIDED|95.0|-1.81|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.44|-1.81|0.2302
74057418|NCT01694849|147665721|SUPERIORITY||Difference in least square mean change|-9.08|||<|0.001|TWO_SIDED|95.0|-13.12|-5.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-5.04|-13.12|<0.001
74057419|NCT01694849|147665722|SUPERIORITY||Difference in least square mean change|0.02||||0.531|TWO_SIDED|95.0|-0.05|0.09|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.09|-0.05|0.531
74057420|NCT01694849|147665722|SUPERIORITY||Difference in least square mean change|-0.02||||0.638|TWO_SIDED|95.0|-0.08|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.08|0.638
74057421|NCT01694849|147665723|SUPERIORITY||Difference in least square mean change|-0.14||||0.831|TWO_SIDED|95.0|-1.39|1.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Total bilirubin||1.12|-1.39|0.831
74057422|NCT01694849|147665723|SUPERIORITY||Difference in least square mean change|0.2||||0.754|TWO_SIDED|95.0|-1.07|1.47|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Total bilirubin||1.47|-1.07|0.754
74057423|NCT01694849|147665723|SUPERIORITY||Difference in least square mean change|-0.03||||0.848|TWO_SIDED|95.0|-0.36|0.3|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Conjugated Bilirubin||0.3|-0.36|0.848
74057424|NCT01694849|147665723|SUPERIORITY||Difference in least square mean change|0.11||||0.511|TWO_SIDED|95.0|-0.22|0.45|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Conjugated Bilirubin||0.45|-0.22|0.511
74057425|NCT01694849|147665724|SUPERIORITY||Difference in least square mean change|-2.83||||0.075|TWO_SIDED|95.0|-5.95|0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.29|-5.95|0.075
74057426|NCT01694849|147665724|SUPERIORITY||Difference in least square mean change|-1.11||||0.491|TWO_SIDED|95.0|-4.29|2.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||2.07|-4.29|0.491
74100981|NCT03097991|147751798|SUPERIORITY||Slope|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.07|TWO_SIDED||||||Mixed Models Analysis||Group|||||.07
74100982|NCT03097991|147751799|SUPERIORITY||Slope|-0.85|STANDARD_ERROR_OF_MEAN|1.9||0.65|TWO_SIDED||||||Mixed Models Analysis||Group|||||.65
74057427|NCT01694849|147665725|SUPERIORITY||Difference in least square mean change|-0.03||||0.393|TWO_SIDED|95.0|-0.1|0.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.04|-0.1|0.393
74057428|NCT01694849|147665725|SUPERIORITY||Difference in least square mean change|-0.04||||0.289|TWO_SIDED|95.0|-0.11|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|-0.11|0.289
74057429|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|-0.47|||<|0.001|TWO_SIDED|95.0|-0.73|-0.21|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Triglycerides||-0.21|-0.73|<0.001
74057430|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|-0.55|||<|0.001|TWO_SIDED|95.0|-0.81|-0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Triglycerides||-0.29|-0.81|<0.001
74100983|NCT03097991|147751799|SUPERIORITY||Slope|-1.65|STANDARD_ERROR_OF_MEAN|2.44||0.5|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.50
74100984|NCT03097991|147751800|SUPERIORITY||Slope|0.92|STANDARD_ERROR_OF_MEAN|1.3||0.48|TWO_SIDED||||||Mixed Models Analysis||Group|||||.48
73881734|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.46||0.1544|TWO_SIDED|95.0|-1.55|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.25|-1.55|0.1544
74057431|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|-0.35||||0.001|TWO_SIDED|95.0|-0.56|-0.14|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Cholesterol||-0.14|-0.56|0.001
74057432|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|-0.43|||<|0.001|TWO_SIDED|95.0|-0.64|-0.23|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Cholesterol||-0.23|-0.64|<0.001
74057433|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|-0.46|||<|0.001|TWO_SIDED|95.0|-0.67|-0.24|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Non-high Density Lipoproteins Cholesterol||-0.24|-0.67|<0.001
74057434|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.32|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Non-high Density Lipoproteins Cholesterol||-0.32|-0.75|<0.001
74100985|NCT03097991|147751800|SUPERIORITY||Slope|-1.92|STANDARD_ERROR_OF_MEAN|1.72||0.27|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.27
74100986|NCT03097991|147751801|SUPERIORITY||Slope|-1.15|STANDARD_ERROR_OF_MEAN|1.22||0.01|TWO_SIDED||||||Mixed Models Analysis||Group|||||.01
74100987|NCT03097991|147751801|SUPERIORITY||Slope|1.08|STANDARD_ERROR_OF_MEAN|1.96||0.58|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.58
74100988|NCT02006732|147751804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.261|0.336|||Mixed Effects Model for Repeated Measure|||||0.336|0.261|<0.0001
74057435|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|0.09||||0.005|TWO_SIDED|95.0|0.03|0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|High Density Lipoproteins Cholesterol||0.15|0.03|0.005
74057436|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|0.11|||<|0.001|TWO_SIDED|95.0|0.05|0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|High Density Lipoproteins Cholesterol||0.17|0.05|<0.001
74057437|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|-0.18|||<|0.001|TWO_SIDED|95.0|-0.26|-0.11|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Very Low Density Lipoproteins Cholesterol||-0.11|-0.26|<0.001
74057438|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|-0.17|||<|0.001|TWO_SIDED|95.0|-0.25|-0.09|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Very Low Density Lipoproteins Cholesterol||-0.09|-0.25|<0.001
74057439|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|-0.2||||0.031|TWO_SIDED|95.0|-0.38|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Low Density Lipoproteins Cholesterol||-0.02|-0.38|0.031
74057440|NCT01694849|147665726|SUPERIORITY||Difference in least square mean change|-0.24||||0.009|TWO_SIDED|95.0|-0.42|-0.06|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Low Density Lipoproteins Cholesterol||-0.06|-0.42|0.009
74057441|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|5.73||||0.038|TWO_SIDED|95.0|0.31|11.14|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo A1||11.14|0.31|0.038
74057442|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|7.07||||0.012|TWO_SIDED|95.0|1.59|12.55|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo A1||12.55|1.59|0.012
74057443|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-12.41|||<|0.001|TWO_SIDED|95.0|-17.56|-7.25|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo B||-7.25|-17.56|<0.001
74057444|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-9.61|||<|0.001|TWO_SIDED|95.0|-14.81|-4.41|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo B||-4.41|-14.81|<0.001
74057445|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|3.55|||<|0.001|TWO_SIDED|95.0|2.14|4.96|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo AII||4.96|2.14|<0.001
74057446|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|6.1|||<|0.001|TWO_SIDED|95.0|4.67|7.53|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo AII||7.53|4.67|<0.001
74057447|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-2.27|||<|0.001|TWO_SIDED|95.0|-3.29|-1.25|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII||-1.25|-3.29|<0.001
74057448|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-1.5||||0.004|TWO_SIDED|95.0|-2.52|-0.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII||-0.49|-2.52|0.004
74057449|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-1.78|||<|0.001|TWO_SIDED|95.0|-2.63|-0.92|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/B||-0.92|-2.63|<0.001
74057450|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-1.15||||0.009|TWO_SIDED|95.0|-2.0|-0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/B||-0.29|-2|0.009
74057451|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-0.46||||0.002|TWO_SIDED|95.0|-0.75|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/nonB||-0.17|-0.75|0.002
74057452|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-0.39||||0.008|TWO_SIDED|95.0|-0.68|-0.1|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/nonB||-0.1|-0.68|0.008
74057453|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-2.35||||0.069|TWO_SIDED|95.0|-4.89|0.19|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Small dense Low Density Lipoproteins||0.19|-4.89|0.069
74057454|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-3.39||||0.01|TWO_SIDED|95.0|-5.95|-0.84|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Small dense Low Density Lipoproteins||-0.84|-5.95|0.01
74057455|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|0.84||||0.549|TWO_SIDED|95.0|-1.93|3.61|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Lp(a)||3.61|-1.93|0.549
74057456|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|0.49||||0.728|TWO_SIDED|95.0|-2.28|3.26|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Lp(a)||3.26|-2.28|0.728
74057457|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-1.38|||<|0.001|TWO_SIDED|95.0|-2.14|-0.61|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E||-0.61|-2.14|<0.001
74057458|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-1.12||||0.004|TWO_SIDED|95.0|-1.89|-0.36|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E||-0.36|-1.89|0.004
74057459|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-1.18|||<|0.001|TWO_SIDED|95.0|-1.82|-0.53|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E/B||-0.53|-1.82|<0.001
74057460|NCT01694849|147665727|SUPERIORITY||Difference in least square mean change|-1.08||||0.001|TWO_SIDED|95.0|-1.72|-0.43|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E/B||-0.43|-1.72|0.001
74057461|NCT01694849|147665728|SUPERIORITY||Difference in least square mean change|-2.8||||0.066|TWO_SIDED|95.0|-5.79|0.18|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Least square mean changes from baseline|||0.18|-5.79|0.066
74100989|NCT02006732|147751804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.069|0.141|||Mixed Effects Model for Repeated Measure|||||0.141|0.069|<0.0001
74100990|NCT02006732|147751804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.246|0.323|||Mixed Effects Model for Repeated Measure|||||0.323|0.246|<0.0001
74057462|NCT01694849|147665728|SUPERIORITY||Difference in least square mean change|0.77||||0.615|TWO_SIDED|95.0|-2.24|3.77|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.77|-2.24|0.615
74057463|NCT01694849|147665729|SUPERIORITY||Difference in least square mean change|-17.4||||0.307|TWO_SIDED|95.0|-50.88|16.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||16.08|-50.88|0.307
74100991|NCT02006732|147751804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.053|0.128|||Mixed Effects Model for Repeated Measure|||||0.128|0.053|<0.0001
74100992|NCT02006732|147751804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.156|0.232|||Mixed Effects Model for Repeated Measure|||||0.232|0.156|<0.0001
74100993|NCT02006732|147751804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.019||0.4499|TWO_SIDED|95.0|-0.023|0.051|||Mixed Effects Model for Repeated Measure|||||0.051|-0.023|0.4499
74100994|NCT02006732|147751805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.129|0.203|||Mixed Effects Model for Repeated Measure|||||0.203|0.129|<0.0001
74057464|NCT01694849|147665729|SUPERIORITY||Difference in least square mean change|-21.41||||0.213|TWO_SIDED|95.0|-55.17|12.34|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||12.34|-55.17|0.213
74057465|NCT01694849|147665730|SUPERIORITY||Difference in least square mean change|-0.23||||0.003|TWO_SIDED|95.0|-0.37|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.08|-0.37|0.003
74057466|NCT01694849|147665730|SUPERIORITY||Difference in least square mean change|-0.14||||0.068|TWO_SIDED|95.0|-0.29|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.29|0.068
74057467|NCT01694849|147665731|SUPERIORITY||Difference in least square mean change|-0.8||||0.448|TWO_SIDED|95.0|-2.86|1.27|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.27|-2.86|0.448
74057468|NCT01694849|147665731|SUPERIORITY||Difference in least square mean change|-1.17||||0.267|TWO_SIDED|95.0|-3.25|0.9|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.9|-3.25|0.267
74100995|NCT02006732|147751805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.019||0.0395|TWO_SIDED|95.0|0.002|0.076|||Mixed Effects Model for Repeated Measure|||||0.076|0.002|0.0395
74057469|NCT01694849|147665732|SUPERIORITY||Difference in least square mean change|-0.05||||0.095|TWO_SIDED|95.0|-0.11|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.11|0.095
74057470|NCT01694849|147665732|SUPERIORITY||Difference in least square mean change|-0.07||||0.022|TWO_SIDED|95.0|-0.13|-0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.01|-0.13|0.022
74100996|NCT02006732|147751805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.132|0.207|||Mixed Effects Model for Repeated Measure|||||0.207|0.132|<0.0001
74057471|NCT01694849|147665733|SUPERIORITY||Difference in least square mean change|-0.46||||0.077|TWO_SIDED|95.0|-0.96|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.96|0.077
74057472|NCT01694849|147665733|SUPERIORITY||Difference in least square mean change|-0.36||||0.172|TWO_SIDED|95.0|-0.87|0.16|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.16|-0.87|0.172
74057473|NCT01694849|147665734|SUPERIORITY||Difference in least square mean change|-0.04||||0.732|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.17|-0.24|0.732
74057474|NCT01694849|147665734|SUPERIORITY||Difference in least square mean change|-0.2||||0.062|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.4|0.062
74057475|NCT01694849|147665735|SUPERIORITY||Difference in least square mean change|3.66||||0.4|TWO_SIDED|95.0|-4.89|12.2|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||12.2|-4.89|0.4
74057476|NCT01694849|147665735|SUPERIORITY||Difference in least square mean change|-16.22|||<|0.001|TWO_SIDED|95.0|-24.99|-7.44|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-7.44|-24.99|<0.001
74057477|NCT01694849|147665736|SUPERIORITY||Difference in least square mean change|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Fibrinogen||-0.17|-0.54|<0.001
74057478|NCT01694849|147665736|SUPERIORITY||Difference in least square mean change|-0.27||||0.005|TWO_SIDED|95.0|-0.46|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors||Fibrinogen|Standard error of the least square mean|-0.08|-0.46|0.005
74057479|NCT01694849|147665736|SUPERIORITY||Difference in least square mean change|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Haptoglobin||-0.15|-0.35|<0.001
74100997|NCT02006732|147751805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.019||0.0269|TWO_SIDED|95.0|0.005|0.079|||Mixed Effects Model for Repeated Measure|||||0.079|0.005|0.0269
74100998|NCT02006732|147751805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.09|0.165|||Mixed Effects Model for Repeated Measure|||||0.165|0.090|<0.0001
74057480|NCT01694849|147665736|SUPERIORITY||Difference in least square mean change|-0.27|||<|0.001|TWO_SIDED|95.0|-0.37|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Haptoglobin||-0.17|-0.37|<0.001
74057481|NCT01694849|147665737|SUPERIORITY||Difference in least square mean change|0.57||||0.742|TWO_SIDED|95.0|-2.9|4.06|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Tumour Necrosis Factor alpha||4.06|-2.9|0.742
74100999|NCT02006732|147751805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.019||0.8669|TWO_SIDED|95.0|-0.04|0.034|||Mixed Effects Model for Repeated Measure|||||0.034|-0.040|0.8669
74101000|NCT02006732|147751806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.564|STANDARD_ERROR_OF_MEAN|0.986|<|0.0001|TWO_SIDED|95.0|-6.499|-2.629|||Mixed Effects Model for Repeated Measure|||||-2.629|-6.499|<0.0001
74101001|NCT02006732|147751806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.717|STANDARD_ERROR_OF_MEAN|0.974||0.078|TWO_SIDED|95.0|-3.628|0.193|||Mixed Effects Model for Repeated Measure|||||0.193|-3.628|0.0780
74101002|NCT02006732|147751806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.666|STANDARD_ERROR_OF_MEAN|0.991||0.0002|TWO_SIDED|95.0|-5.611|-1.721|||Mixed Effects Model for Repeated Measure|||||-1.721|-5.611|0.0002
74057482|NCT01694849|147665737|SUPERIORITY||Difference in least square mean change|2.9||||0.107|TWO_SIDED|95.0|-0.63|6.43|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Tumour Necrosis Factor alpha||6.43|-0.63|0.107
74057483|NCT01694849|147665737|SUPERIORITY||Difference in least square mean change|0.5||||0.362|TWO_SIDED|95.0|-0.58|1.59|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Interleukine 6||1.59|-0.58|0.362
74057484|NCT01694849|147665737|SUPERIORITY||Difference in least square mean change|0.07||||0.894|TWO_SIDED|95.0|-1.03|1.18|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Interleukine 6||1.18|-1.03|0.894
74057485|NCT01694849|147665738|SUPERIORITY||Difference in least square mean change|-0.76||||0.229|TWO_SIDED|95.0|-2.0|0.48|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.48|-2|0.229
74057486|NCT01694849|147665738|SUPERIORITY||Difference in least square mean change|-0.45||||0.463|TWO_SIDED|95.0|-1.67|0.76|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.76|-1.67|0.463
74057487|NCT01694849|147665739|SUPERIORITY||Difference in least square mean change|-0.21||||0.065|TWO_SIDED|95.0|-0.42|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.42|0.065
74101003|NCT02006732|147751806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.979||0.4028|TWO_SIDED|95.0|-2.741|1.102|||Mixed Effects Model for Repeated Measure|||||1.102|-2.741|0.4028
74101004|NCT02006732|147751806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.993||0.0042|TWO_SIDED|95.0|-4.796|-0.897|||Mixed Effects Model for Repeated Measure|||||-0.897|-4.796|0.0042
73881735|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.6847|TWO_SIDED|95.0|-1.1|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.72|-1.10|0.6847
74057488|NCT01694849|147665739|SUPERIORITY||Difference in least square mean change|-0.19||||0.098|TWO_SIDED|95.0|-0.41|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|-0.41|0.098
74057489|NCT01694849|147665740|SUPERIORITY||Difference in least square mean change|0.7||||0.553|TWO_SIDED|95.0|-1.61|3.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.01|-1.61|0.553
74057490|NCT01694849|147665740|SUPERIORITY||Difference in least square mean change|4.31|||<|0.001|TWO_SIDED|95.0|1.97|6.64|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||6.64|1.97|<0.001
74057491|NCT01694849|147665741|SUPERIORITY||Difference in least square mean change|0.04||||0.861|TWO_SIDED|95.0|-0.37|0.44|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.44|-0.37|0.861
74057492|NCT01694849|147665741|SUPERIORITY||Difference in least square mean change|-0.4||||0.052|TWO_SIDED|95.0|-0.81|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|-0.81|0.052
74057493|NCT01694849|147665742|SUPERIORITY||Difference in least square mean change|0.01||||0.473|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.02|-0.01|0.473
74057494|NCT01694849|147665742|SUPERIORITY||Difference in least square mean change|0.01||||0.124|TWO_SIDED|95.0|0.0|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|0|0.124
74057495|NCT01694849|147665743|SUPERIORITY||Difference in least square mean change|0.81|||<|0.001|TWO_SIDED|95.0|0.47|1.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.15|0.47|<0.001
74057496|NCT01694849|147665743|SUPERIORITY||Difference in least square mean change|0.85|||<|0.001|TWO_SIDED|95.0|0.5|1.19|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.19|0.5|<0.001
74057497|NCT01694849|147665744|SUPERIORITY||Difference in least square mean change|0.0||||0.842|TWO_SIDED|95.0|-0.04|0.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.04|-0.04|0.842
74057498|NCT01694849|147665744|SUPERIORITY||Difference in least square mean change|0.01||||0.589|TWO_SIDED|95.0|-0.03|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.03|0.589
74101005|NCT02006732|147751806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.898|STANDARD_ERROR_OF_MEAN|0.971||0.3555|TWO_SIDED|95.0|-2.804|1.008|||Mixed Effects Model for Repeated Measure|||||1.008|-2.804|0.3555
74101006|NCT02006732|147751807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.668|STANDARD_ERROR_OF_MEAN|0.71|<|0.0001|TWO_SIDED|95.0|-6.06|-3.276|||Mixed Effects Model for Repeated Measure|||||-3.276|-6.060|<0.0001
74057499|NCT01694849|147665745|SUPERIORITY||Difference in least square mean change|48.93||||0.325|TWO_SIDED|95.0|-8.73|146.6|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||146.6|-8.73|0.325
74057500|NCT01694849|147665745|SUPERIORITY||Difference in least square mean change|93.21||||0.066|TWO_SIDED|95.0|-6.06|192.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||192.49|-6.06|0.066
74057501|NCT01694849|147665746|SUPERIORITY||Difference in least square mean change|2.41|||<|0.001|TWO_SIDED|95.0|1.1|3.72|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.72|1.1|<0.001
74057502|NCT01694849|147665746|SUPERIORITY||Difference in least square mean change|1.59||||0.019|TWO_SIDED|95.0|0.26|2.91|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||2.91|0.26|0.019
74101007|NCT02006732|147751807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.097|STANDARD_ERROR_OF_MEAN|0.701||0.0028|TWO_SIDED|95.0|-3.471|-0.723|||Mixed Effects Model for Repeated Measure|||||-0.723|-3.471|0.0028
74057503|NCT01694849|147665747|SUPERIORITY||Difference in least square mean change|0.0||||0.447|TWO_SIDED|95.0|0.0|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|0|0.447
74057504|NCT01694849|147665747|SUPERIORITY||Difference in least square mean change|0.0||||0.758|TWO_SIDED|95.0|0.0|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|0|0.758
74057505|NCT01694849|147665748|SUPERIORITY||Difference in least square mean change|-0.04||||0.942|TWO_SIDED|95.0|-1.12|1.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.04|-1.12|0.942
74057506|NCT01694849|147665748|SUPERIORITY||Difference in least square mean change|0.57||||0.304|TWO_SIDED|95.0|-0.52|1.66|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.66|-0.52|0.304
74057507|NCT00145795|147665768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 3 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.||||0.81
74101008|NCT02006732|147751807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.846|STANDARD_ERROR_OF_MEAN|0.711|<|0.0001|TWO_SIDED|95.0|-5.24|-2.451|||Mixed Effects Model for Repeated Measure|||||-2.451|-5.240|<0.0001
74101009|NCT02006732|147751807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.274|STANDARD_ERROR_OF_MEAN|0.702||0.0696|TWO_SIDED|95.0|-2.651|0.102|||Mixed Effects Model for Repeated Measure|||||0.102|-2.651|0.0696
74101010|NCT02006732|147751807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.571|STANDARD_ERROR_OF_MEAN|0.714||0.0003|TWO_SIDED|95.0|-3.971|-1.171|||Mixed Effects Model for Repeated Measure|||||-1.171|-3.971|0.0003
74057508|NCT00145795|147665769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||||||Significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 6 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.||||0.03
74101011|NCT02006732|147751807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.822|STANDARD_ERROR_OF_MEAN|0.698||0.2387|TWO_SIDED|95.0|-2.191|0.546|||Mixed Effects Model for Repeated Measure|||||0.546|-2.191|0.2387
74101012|NCT02006732|147751808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.187|0.317|||Mixed Effects Model for Repeated Measure|||||0.317|0.187|<0.0001
74057509|NCT00145795|147665770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 3 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.||||0.08
74057510|NCT00145795|147665771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 3 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.||||0.29
74057511|NCT00145795|147665772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 6 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.||||0.29
74057512|NCT00145795|147665773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 6 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.||||0.04
74057513|NCT00145795|147665774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 3 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.||||0.21
74057514|NCT00145795|147665775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 6 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.||||0.61
74101013|NCT02006732|147751808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.033||0.0614|TWO_SIDED|95.0|-0.003|0.125|||Mixed Effects Model for Repeated Measure|||||0.125|-0.003|0.0614
74101014|NCT02006732|147751808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.305|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.24|0.37|||Mixed Effects Model for Repeated Measure|||||0.370|0.240|<0.0001
74057515|NCT00570492|147665778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-0.48|-0.06|||||An analysis of covariance (ANCOVA) was performed to estimate the mean treatment difference in growth velocity over the treatment period, adjusting for baseline growth velocity, age, gender, and country.|||-0.06|-0.48|
74057516|NCT00908375|147665795|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was determined based on the primary outcome variable, the VAS pain score at three weeks. Based on the results of the study of Siddall et al., group sample sizes of 19 and 19 achieve 82% power to detect a difference of 2.00 between the null hypothesis that both group means are 6.50 and the alternative hypothesis that the mean of pregabalin group is 4.50 with estimated group standard deviations of 2.10 and 2.10 and with a significance level of 0.05 using a two-sided two-sample t-test.|Median Difference (Final Values)|-2.0||||0.279|TWO_SIDED|99.0|-6.0|3.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple application of the test to the same data set using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||3|-6|0.279
74057517|NCT00908375|147665796|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.282|TWO_SIDED|99.0|-2.0|1.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||1.0|-2.0|0.282
74057518|NCT00908375|147665797|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-16.0||||0.139|TWO_SIDED|99.0|-42.0|16.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||16|-42|0.139
74057519|NCT01298323|147665833|SUPERIORITY_OR_OTHER_LEGACY||t-Statistic|1.29||||0.199|TWO_SIDED|95.0|-3.44|16.37||Statistical significance threshold at this analysis was 10%|t-test, 2 sided|||||16.37|-3.44|0.199
74057520|NCT04409262|147665839|SUPERIORITY||Hazard Ratio (HR)|0.965||||0.7414|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||||1.19|0.78|0.7414
74057521|NCT04409262|147665840|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8993|TWO_SIDED|95.0|0.72|1.34|||Log Rank|||||1.34|0.72|0.8993
74057522|NCT04409262|147665841|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7648|TWO_SIDED|95.0|0.77|1.44|||Regression, Logistic|||||1.44|0.77|0.7648
74057523|NCT04409262|147665842|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.7867|TWO_SIDED|95.0|0.65|1.39|||Log Rank|||||1.39|0.65|0.7867
74057524|NCT04409262|147665843|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.4602|TWO_SIDED|95.0|0.63|1.23|||Log Rank|||||1.23|0.63|0.4602
74057525|NCT04409262|147665844|SUPERIORITY||Hazard Ratio (HR)|0.982||||0.8664|TWO_SIDED|95.0|0.8|1.21|||Log Rank|||||1.21|0.80|0.8664
74057526|NCT04409262|147665845|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9569|TWO_SIDED|95.0|0.75|1.35|||Regression, Logistic|||||1.35|0.75|0.9569
74057527|NCT04409262|147665846|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6331|TWO_SIDED|95.0|0.78|1.52|||Regression, Logistic|||||1.52|0.78|0.6331
74057528|NCT04409262|147665847|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9622|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|||||1.40|0.70|0.9622
74057529|NCT04409262|147665848|SUPERIORITY||Odds Ratio (OR)|1.14||||0.485|TWO_SIDED|95.0|0.79|1.64|||Regression, Logistic|||||1.64|0.79|0.4850
74057530|NCT04409262|147665849|SUPERIORITY||Weighted % difference|-2.2||||0.5915|TWO_SIDED|95.0|-10.2|5.9|||Cochran-Mantel-Haenszel|||Day 28||5.9|-10.2|0.5915
74057531|NCT04409262|147665849|SUPERIORITY||Weighted % difference|-2.5||||0.5494|TWO_SIDED|95.0|-10.5|5.6|||Cochran-Mantel-Haenszel|||Day 60||5.6|-10.5|0.5494
74057532|NCT04409262|147665850|SUPERIORITY||Weighted % difference|-14.1||||0.259|TWO_SIDED|95.0|-37.4|9.2|||Cochran-Mantel-Haenszel|||Day 28||9.2|-37.4|0.2590
74057533|NCT04409262|147665850|SUPERIORITY||Weighted % difference|-14.6||||0.229|TWO_SIDED|95.0|-37.0|7.8|||Cochran-Mantel-Haenszel|||Day 60||7.8|-37.0|0.2290
74057534|NCT04409262|147665851|SUPERIORITY||Mean Difference (Final Values)|3.1125||||0.2434|TWO_SIDED|95.0|-2.16|8.38|||Regression, Linear|||||8.38|-2.16|0.2434
74057535|NCT04409262|147665852|SUPERIORITY||Weighted % difference|0.6||||0.8222|TWO_SIDED|95.0|-4.4|5.6|||Cochran-Mantel-Haenszel|||Day 14||5.6|-4.4|0.8222
74057536|NCT04409262|147665852|SUPERIORITY||Weighted % difference|-1.3||||0.6944|TWO_SIDED|95.0|-7.8|5.2|||Cochran-Mantel-Haenszel|||Day 28||5.2|-7.8|0.6944
74057537|NCT04409262|147665852|SUPERIORITY||Weighted % difference|-3.0||||0.3919|TWO_SIDED|95.0|-10.1|4.0|||Cochran-Mantel-Haenszel|||Day 60||4.0|-10.1|0.3919
74057538|NCT04409262|147665853|SUPERIORITY||Hazard Ratio (HR)|0.957||||0.6778|TWO_SIDED|95.0|0.78|1.18|||Log Rank|||||1.18|0.78|0.6778
74057539|NCT04409262|147665854|SUPERIORITY||Weighted % difference|-0.9||||0.7692|TWO_SIDED|95.0|-8.7|6.8|||Cochran-Mantel-Haenszel|||||6.8|-8.7|0.7692
74057540|NCT04409262|147665855|SUPERIORITY||Weighted % difference|-0.3||||0.9334|TWO_SIDED|95.0|-7.8|7.2|||Cochran-Mantel-Haenszel|||||7.2|-7.8|0.9334
74057541|NCT00931515|147665869|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
74057542|NCT01790633|147665920|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \< 0.05|Chi-squared|||We approached our analysis as a pilot study with the aim of addressing feasibility. 70% of patients seen at the MDM clinic obtain a test result with standard serology. Assuming a 20% increase in infection awareness and type 1 error of 0.05, and power of at least 0.9, a minimum of 82 participants per group would be needed.||||<0.001
74057543|NCT01790633|147665921|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \< 0.05|Chi-squared|||||||0.7
74057544|NCT00157157|147665935|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.95||||||95.0|1.29|19.06||||||||19.06|1.29|
74057545|NCT00157157|147665936|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.18||||||95.0|1.18|14.82||||||||14.82|1.18|
74057546|NCT00157157|147665937|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5||||||95.0|1.05|19.25||||||||19.25|1.05|
74057547|NCT01678794|147665938|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
74057548|NCT01678794|147665939|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
74057549|NCT02260804|147665955|EQUIVALENCE|The equivalence margin of ±17% was predefined.|Difference in proportion|1.8|||||TWO_SIDED|90.0|-6.43|10.2||||||||10.2|-6.43|
74101015|NCT02006732|147751808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.033||0.0005|TWO_SIDED|95.0|0.049|0.178|||Mixed Effects Model for Repeated Measure|||||0.178|0.049|0.0005
74101016|NCT02006732|147751808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.126|0.256|||Mixed Effects Model for Repeated Measure|||||0.256|0.126|<0.0001
74101017|NCT02006732|147751808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.033||0.1089|TWO_SIDED|95.0|-0.117|0.012|||Mixed Effects Model for Repeated Measure|||||0.012|-0.117|0.1089
74101018|NCT02006732|147751809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.195|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|0.665|1.725|||Mixed Effects Model for Repeated Measure|||||1.725|0.665|<0.0001
74101019|NCT02006732|147751809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.267||0.0296|TWO_SIDED|95.0|0.058|1.106|||Mixed Effects Model for Repeated Measure|||||1.106|0.058|0.0296
74101020|NCT02006732|147751809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263|STANDARD_ERROR_OF_MEAN|0.272|<|0.0001|TWO_SIDED|95.0|0.73|1.796|||Mixed Effects Model for Repeated Measure|||||1.796|0.730|<0.0001
74101021|NCT02006732|147751809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.269||0.0159|TWO_SIDED|95.0|0.122|1.178|||Mixed Effects Model for Repeated Measure|||||1.178|0.122|0.0159
74101022|NCT02006732|147751809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.613|STANDARD_ERROR_OF_MEAN|0.273||0.0248|TWO_SIDED|95.0|0.078|1.148|||Mixed Effects Model for Repeated Measure|||||1.148|0.078|0.0248
74101023|NCT02006732|147751809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.266||0.7984|TWO_SIDED|95.0|-0.59|0.454|||Mixed Effects Model for Repeated Measure|||||0.454|-0.590|0.7984
74101024|NCT02006732|147751810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.623|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|1.245|2.0|||Mixed Effects Model for Repeated Measure|||||2.000|1.245|<0.0001
74101025|NCT02006732|147751810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.594|STANDARD_ERROR_OF_MEAN|0.19||0.0019|TWO_SIDED|95.0|0.22|0.967|||Mixed Effects Model for Repeated Measure|||||0.967|0.220|0.0019
74101026|NCT02006732|147751810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.611|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|1.232|1.989|||Mixed Effects Model for Repeated Measure|||||1.989|1.232|<0.0001
74101027|NCT02006732|147751810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.191||0.0023|TWO_SIDED|95.0|0.207|0.956|||Mixed Effects Model for Repeated Measure|||||0.956|0.207|0.0023
74101028|NCT02006732|147751810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.029|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|0.649|1.41|||Mixed Effects Model for Repeated Measure|||||1.410|0.649|<0.0001
74101029|NCT02006732|147751810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.189||0.9494|TWO_SIDED|95.0|-0.359|0.383|||Mixed Effects Model for Repeated Measure|||||0.383|-0.359|0.9494
74101030|NCT02006732|147751811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.432|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.366|0.498|||Mixed Effects Model for Repeated Measure|||||0.498|0.366|<0.0001
74101031|NCT02006732|147751811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.084|0.212|||Mixed Effects Model for Repeated Measure|||||0.212|0.084|<0.0001
74101032|NCT02006732|147751811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.455|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.387|0.522|||Mixed Effects Model for Repeated Measure|||||0.522|0.387|<0.0001
74101033|NCT02006732|147751811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.105|0.236|||Mixed Effects Model for Repeated Measure|||||0.236|0.105|<0.0001
74101034|NCT02006732|147751811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.217|0.35|||Mixed Effects Model for Repeated Measure|||||0.350|0.217|<0.0001
74101035|NCT02006732|147751811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.033||0.4974|TWO_SIDED|95.0|-0.087|0.042|||Mixed Effects Model for Repeated Measure|||||0.042|-0.087|0.4974
74101036|NCT00307437|147751845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||<0.001
74101037|NCT00307437|147751845|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for the multiplicity for the primary endpoint analysis, the Holm's procedure was used at an overall significance level of 0.05.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 1200 participants (400 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight \[\<=90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.001
74101038|NCT00307437|147751846|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||||||<0.001
74057550|NCT01740297|147666099|SUPERIORITY||Odds Ratio (OR)|2.9||||0.002|TWO_SIDED|95.0|1.5|5.5|||Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||5.5|1.5|0.002
74057551|NCT01740297|147666102|OTHER||Odds Ratio (OR)|1.9||||0.033|TWO_SIDED|95.0|1.1|3.4||P-value is descriptive|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||3.4|1.1|0.033
74101039|NCT00307437|147751846|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint need to be significant first.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significancd level of 0.05.||||<0.001
74101040|NCT00307437|147751847|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||||||<0.001
74101041|NCT00307437|147751847|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first.|ANOVA on van der Waerden normal scores|Analysis of varianceon van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤90 kg vs \>90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
74101042|NCT00307437|147751848|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||0.468
74101043|NCT00307437|147751848|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||0.210
74101044|NCT00307437|147751848|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested.|Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between combined q8 group and the combined q12 group, 45 mg q8 and 45 mg q12, 90 mg q8 and 90 mg q12 at an overall significance level of 0.05.||||0.014
74101045|NCT02933255|147751857|OTHER||||||<|0.0001||||||The reported p-value is representative of changes in CD8+T cell infiltration within the total tissue at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||<0.0001
74101046|NCT02933255|147751857|OTHER|||||||0.04||||||The reported p-value is representative of changes in CD8+T cell infiltration in the center of the tumor at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.04
74101047|NCT02933255|147751857|OTHER|||||||0.002||||||The reported p-value is representative of changes in CD8+T cell infiltration in the invasive margin at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.002
74057552|NCT01740297|147666103|OTHER||Odds Ratio (OR)|2.8||||0.007|TWO_SIDED|95.0|1.4|5.8||P-value is descriptive.|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||5.8|1.4|0.007
74101048|NCT02933255|147751857|OTHER|||||||0.46||||||The reported p-value is representative of changes in CD8+T cell infiltration in the normal region at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.46
74101049|NCT02933255|147751857|OTHER||||||<|0.0001||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the total tissue at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||<0.0001
74101050|NCT02933255|147751857|OTHER|||||||0.016||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the center of the tumor at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.016
74101051|NCT02933255|147751857|OTHER|||||||0.002||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the invasive margin at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.002
74101052|NCT02933255|147751857|OTHER|||||||0.38||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the normal region at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.38
74101053|NCT02933255|147751859|OTHER|The reported p-value is representative of changes in soluble factors at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.||||||0.064|||||||Wilcoxon Signed Rank Test|||||||0.064
74057553|NCT01740297|147666104|OTHER||Hazard Ratio (HR)|1.41||||0.228|TWO_SIDED|95.0|0.8|2.49||P-value is descriptive|Log Rank||Obtained from unstratified Cox Proportional Hazard Model.|||2.49|0.80|0.228
74057554|NCT01740297|147666106|OTHER||Hazard Ratio (HR)|0.83||||0.348|TWO_SIDED|95.0|0.56|1.23|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.23|0.56|0.348
74057555|NCT01740297|147666107|OTHER|||||||0.696|||||||Chi-squared, Corrected|||||||0.696
74057556|NCT01740297|147666108|OTHER||Hazard Ratio (HR)|0.8||||0.474|TWO_SIDED|95.0|0.44|1.46|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.46|0.44|0.474
74057557|NCT01740297|147666110|OTHER||Hazard Ratio (HR)|0.78||||0.14|TWO_SIDED|95.0|0.55|1.09|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.09|0.55|0.14
74101054|NCT02933255|147751859|OTHER|The reported p-value is representative of changes in soluble factors at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.||||||0.001|||||||Wilcoxon Signed Rank Test|||||||0.001
74101055|NCT02933255|147751859|OTHER|||||||0.003||||||The reported p-value is representative of changes in soluble factors at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.003
74101056|NCT02933255|147751859|OTHER|||||||0.003||||||The reported p-value is representative of changes in soluble factors at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.003
74101057|NCT02933255|147751859|OTHER|||||||0.004||||||The reported p-value is representative of changes in soluble factors at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.004
74057558|NCT01740297|147666111|OTHER||Hazard Ratio (HR)|0.83||||0.37|TWO_SIDED|95.0|0.56|1.24|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.24|0.56|0.37
74057559|NCT01966458|147666114|NON_INFERIORITY|A non-inferiority margin of 6% was pre-specified.|Risk Difference (RD)|2.6||||0.1444|TWO_SIDED|90.0|-5.5|10.7|||Farrington-Manning asymptotic test||Difference = HeartWare® VAS incidence rate - Control incidence rate Two-sided 90% exact binomial confident interval is used.|The primary endpoint is a non-inferiority test comparing HeartWare® VAS to Control.||10.7|-5.5|0.1444
74057560|NCT01966458|147666115|SUPERIORITY||Percent of Participants|19.2||||0.7363|TWO_SIDED|90.0|15.6|23.3|||Exact Binomial Test||Two-sided exact binomial confidence interval used|The first secondary endpoint is the percent of participants with stroke/TIA at 12 months on the originally implanted device. It will be compared to 17.7%, which is the lower bound of a pre-defined margin of superiority based on the Endurance clinical trial.||23.3|15.6|0.7363
74057561|NCT01966458|147666116|NON_INFERIORITY|The non-inferiority margin on the difference in success proportions is 15%.|Difference in Percentages|-9.2|||<|0.0001|TWO_SIDED|90.0|-17.2|-1.1|||Farrington-Manning asymptotic test||Difference = Control success rate - HeartWare® VAS success rate Two-sided 90% exact binomial confidence interval is used|||-1.1|-17.2|<0.0001
74057562|NCT01966458|147666116|SUPERIORITY|||||||0.0354|||||||Chi-squared|||||||0.0354
74057563|NCT00463385|147666141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||Fisher Exact|||||||0.092
74057564|NCT00463385|147666141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048||95.0|||||Fisher Exact|||||||0.048
74057565|NCT00463385|147666141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758||95.0|||||Fisher Exact|||||||0.758
74057566|NCT01969201|147666168|NON_INFERIORITY|The non-inferiority was evaluated by calculating the 95% CI for the differences in pregnancy rates between the two treatment groups. If the lower bound of the 95% CI of the difference between the two proportions was greater than -0.10 (i.e. 10%), then Fostimon was to be considered not inferior to the control treatment.|Mean Difference (Final Values)|-2.73||||0.49|TWO_SIDED|95.0|-9.88|4.42|||Fisher Exact|||||4.42|-9.88|0.49
74057567|NCT01969201|147666169|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
74057568|NCT01969201|147666170|OTHER|||||||0.02|||||||ANOVA|||||||0.02
74057569|NCT01969201|147666171|OTHER|||||||0.32|||||||ANOVA|||||||0.32
74057570|NCT01969201|147666172|OTHER|||||||0.89|||||||ANOVA|||||||0.89
74057571|NCT01969201|147666173|OTHER|||||||0.5|||||||Fisher Exact|||||||0.5
74057572|NCT01969201|147666174|OTHER|||||||0.53|||||||Fisher Exact|||||||0.53
74057573|NCT01969201|147666175|OTHER|||||||0.07|||||||Fisher Exact|||||||0.07
74057574|NCT01422876|147666189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.75|-0.41|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.41|-0.75|<0.0001
74057575|NCT01422876|147666189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.67|-0.32|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.32|-0.67|<0.0001
74057576|NCT01422876|147666189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.59|-0.25|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.25|-0.59|<0.0001
74057577|NCT01422876|147666189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.21|-0.56|<0.0001
74057578|NCT01422876|147666190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.43|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-23.37|-9.48|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-9.48|-23.37|<0.0001
74057579|NCT01422876|147666190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.2|STANDARD_ERROR_OF_MEAN|3.62|<|0.0001|TWO_SIDED|95.0|-29.3|-15.1|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-15.10|-29.30|<0.0001
74057580|NCT01422876|147666190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.34|STANDARD_ERROR_OF_MEAN|3.55||0.0015|TWO_SIDED|95.0|-18.31|-4.37|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-4.37|-18.31|0.0015
74057581|NCT01422876|147666190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.12|STANDARD_ERROR_OF_MEAN|3.61|<|0.0001|TWO_SIDED|95.0|-26.21|-12.03|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-12.03|-26.21|<0.0001
74057582|NCT01422876|147666191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.31|STANDARD_ERROR_OF_MEAN|3.78||0.1605|TWO_SIDED|95.0|-12.74|2.11|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||2.11|-12.74|0.1605
74057583|NCT01422876|147666191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.82|STANDARD_ERROR_OF_MEAN|3.78||0.1246|TWO_SIDED|95.0|-13.25|1.61|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||1.61|-13.25|0.1246
74057584|NCT01422876|147666191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.63|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-31.06|-16.21|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||-16.21|-31.06|<0.0001
74057585|NCT01422876|147666191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.29|STANDARD_ERROR_OF_MEAN|3.77|<|0.0001|TWO_SIDED|95.0|-29.71|-14.88|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||-14.88|-29.71|<0.0001
74057586|NCT01422876|147666192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.43||0.6604|TWO_SIDED|95.0|-0.65|1.03||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||1.03|-0.65|0.6604
74057587|NCT01422876|147666192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.15|-1.44|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||-1.44|-3.15|<0.0001
74057588|NCT01422876|147666192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.43||0.8757|TWO_SIDED|95.0|-0.91|0.77||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||0.77|-0.91|0.8757
74057589|NCT01422876|147666192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.91|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.77|-1.05|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||-1.05|-2.77|<0.0001
74057590|NCT01422876|147666193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.1785|TWO_SIDED|95.0|-0.33|0.06|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||0.06|-0.33|0.1785
74057591|NCT01422876|147666193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.21|-0.61|<0.0001
74057592|NCT01422876|147666193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.22|||Cochran-Mantel-Haenszel|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.22|-0.61|<0.0001
74057593|NCT01422876|147666193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.76|-0.37|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.37|-0.76|<0.0001
74057594|NCT01422876|147666194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.51||0.801|TWO_SIDED|95.0|-0.88|1.14||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||1.14|-0.88|0.8010
74057595|NCT01422876|147666194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.51||0.3616|TWO_SIDED|95.0|-1.48|0.54||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||0.54|-1.48|0.3616
74057596|NCT01422876|147666194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.51||0.0178|TWO_SIDED|95.0|-2.23|-0.21|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||-0.21|-2.23|0.0178
74057597|NCT01422876|147666194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.51||0.0001|TWO_SIDED|95.0|-2.97|-0.95|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||-0.95|-2.97|0.0001
74057598|NCT01422876|147666195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.191|||<|0.0001|TWO_SIDED|95.0|2.319|7.573|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||7.573|2.319|<0.0001
74057599|NCT01422876|147666195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|||<|0.0001|TWO_SIDED|95.0|2.474|8.184|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||8.184|2.474|<0.0001
74057600|NCT01422876|147666195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.495|||<|0.0001|TWO_SIDED|95.0|1.92|6.363|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||6.363|1.920|<0.0001
74057601|NCT01422876|147666195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.795||||0.0005|TWO_SIDED|95.0|1.562|5.001|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.001|1.562|0.0005
73881736|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.552|TWO_SIDED|95.0|-1.2|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.64|-1.20|0.5520
74057602|NCT01422876|147666196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.893||||0.0224|TWO_SIDED|95.0|1.095|3.274|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||3.274|1.095|0.0224
74101058|NCT02933255|147751859|OTHER|||||||0.004||||||The reported p-value is representative of changes in soluble factors at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.004
74101059|NCT02933255|147751860|OTHER|||||||0.002||||||The reported p-value is representative of changes in TNFα at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.002
74101060|NCT02933255|147751860|OTHER|||||||0.042||||||The reported p-value is representative of changes in TNFα at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
73881737|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.3632|TWO_SIDED|95.0|-1.36|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.50|-1.36|0.3632
74057603|NCT01422876|147666196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.961||||0.0001|TWO_SIDED|95.0|1.697|5.169|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.169|1.697|0.0001
74057604|NCT01422876|147666196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.065|||<|0.0001|TWO_SIDED|95.0|1.768|5.314|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.314|1.768|<0.0001
74057605|NCT01422876|147666196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.303|||<|0.0001|TWO_SIDED|95.0|2.462|7.522|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||7.522|2.462|<0.0001
74057606|NCT04621227|147666227|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|202.94|||||TWO_SIDED|90.0|167.14|246.41|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 120mg BID + rosuvastatin 10mg \[Period 4\] vs Rosuvastatin 10mg \[Period 1\])||246.41|167.14|
74057607|NCT04621227|147666227|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|283.73|||||TWO_SIDED|90.0|233.68|344.51|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 200mg BID + rosuvastatin 10mg \[Period 7\] vs Rosuvastatin 10mg \[Period 1\])||344.51|233.68|
74057608|NCT04621227|147666228|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|50.57|||||TWO_SIDED|90.0|42.27|60.5|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 120mg BID + midazolam 2mg \[Period 5\] vs Midazolam 2mg \[Period 2\])||60.50|42.27|
74057609|NCT04621227|147666228|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|50.56|||||TWO_SIDED|90.0|42.06|60.78|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 200mg BID + midazolam 2mg \[Period 8\] vs Midazolam 2mg \[Period 2\])||60.78|42.06|
74057610|NCT01366846|147666246|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.||||<0.001
74057611|NCT01366846|147666246|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.||||0.004
74057612|NCT01366846|147666247|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of participants with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Consumption Group across both the SPT-negative and SPT-positive strata.||||<0.001
74057613|NCT01366846|147666248|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.||||<0.001
74057614|NCT01366846|147666248|SUPERIORITY_OR_OTHER|||||||0.027|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.||||0.027
74057615|NCT01366846|147666249|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group across both the SPT-negative and SPT-positive strata.||||<0.001
74057616|NCT01366846|147666250|SUPERIORITY_OR_OTHER|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.||||0.250
74057617|NCT01366846|147666251|SUPERIORITY_OR_OTHER|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.||||0.250
74057618|NCT01342445|147666325|SUPERIORITY_OR_OTHER_LEGACY||Partial eta squared|0.34|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 10.9~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.||||<0.001
74057619|NCT01342445|147666326|SUPERIORITY_OR_OTHER_LEGACY||partial eta squared|0.28|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 8.14~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.||||<.001
74057620|NCT05299359|147666327|NON_INFERIORITY|If the lower limit of the 95% CI is \>= 0.67, then the immune response to a single heterologous booster vaccination of TAK-019 is considered to be non-inferior of that to the primary series of TAK-019.|LS Mean Difference|1.18|||||TWO_SIDED|95.0|0.95|1.47||||||GMT ratio was calculated GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36.||1.47|0.95|
74057621|NCT04579666|147666390|SUPERIORITY||Difference in LS Mean|-3.0||||0.7205|TWO_SIDED|95.0|-19.5|13.5|||ANCOVA|||Analysis of covariance (ANCOVA) was used to analyze the ranks of the CAFS score with treatment as a fixed effect, adjusted for baseline ALSFRS-R total score, time from symptom onset, baseline Log neurofilament light chain (NfL), and the randomization stratification factors (location of first muscle weakness and use of riluzole and edaravone).||13.5|-19.5|0.7205
74057622|NCT04579666|147666395|SUPERIORITY||Difference in LS Mean|-0.7||||0.6447|TWO_SIDED|95.0|-3.5|2.2|||MMRM|||The mixed-effect model for repeated measures (MMRM) included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors location of first muscle weakness and use of riluzole and/or edaravone).||2.2|-3.5|0.6447
74057623|NCT04579666|147666396|SUPERIORITY||Difference in LS Mean|-6.6||||0.0949|TWO_SIDED|95.0|-14.3|1.2|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||1.2|-14.3|0.0949
74101061|NCT02933255|147751860|OTHER|||||||0.233||||||The reported p-value is representative of changes in TNFα at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.233
73881738|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47||0.2828|TWO_SIDED|95.0|-1.43|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.42|-1.43|0.2828
74057624|NCT04579666|147666397|SUPERIORITY||Difference in LS Mean|-0.19||||0.0935|TWO_SIDED|95.0|-0.42|0.03|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||0.03|-0.42|0.0935
74101062|NCT02933255|147751860|OTHER|||||||0.052||||||The reported p-value is representative of changes in TNFα at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.052
74101063|NCT02933255|147751860|OTHER|||||||0.055||||||The reported p-value is representative of changes in TNFα at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.055
74101064|NCT02933255|147751860|OTHER|||||||0.203||||||The reported p-value is representative of changes in TNFα at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.203
74057625|NCT04579666|147666399|SUPERIORITY||Difference in LS Mean|6.5||||0.0069|TWO_SIDED|95.0|1.8|11.1|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||11.1|1.8|0.0069
74057626|NCT01151085|147666428|SUPERIORITY_OR_OTHER||||||=|0.03|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the Frequency of Treatment Related Adverse Events."||||=0.030
74101065|NCT02933255|147751860|OTHER||||||<|0.001||||||The reported p-value is representative of changes in IL-10 at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||<0.001
74101066|NCT02933255|147751860|OTHER|||||||0.034||||||The reported p-value is representative of changes in IL-10 at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.034
74101067|NCT02933255|147751860|OTHER||||||<|0.001||||||The reported p-value is representative of changes in IL-10 at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||<0.001
74101068|NCT02933255|147751860|OTHER|||||||0.034||||||The reported p-value is representative of changes in IL-10 at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.034
73881739|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.4702|TWO_SIDED|95.0|-1.24|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.58|-1.24|0.4702
74101069|NCT02933255|147751860|OTHER|||||||0.004||||||The reported p-value is representative of changes in IL-10 at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.004
74057627|NCT01151085|147666429|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Severity of infections. The null hypothesis is there is no difference among mild, moderate and severe in the Frequency of Treatment Related Adverse Events."||||<0.001
74057628|NCT01151085|147666430|SUPERIORITY_OR_OTHER||||||=|0.017|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past History. The null hypothesis is there is no difference between with and without Past History in the Frequency of Treatment Related Adverse Events."||||=0.017
74057629|NCT01151085|147666431|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Statistical Analysis for Risk Factors for the Proportion of Responders to Voriconazole treatment -Severity of infections.||||<0.001
74057630|NCT03413618|147666469|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74057631|NCT03413618|147666470|SUPERIORITY|||||||0.049|||||||Log Rank|||||||0.049
74057632|NCT03413618|147666472|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74057633|NCT03413618|147666473|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74057634|NCT03413618|147666475|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
74057635|NCT03413618|147666476|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
74057636|NCT04196023|147666487|SUPERIORITY|||||||0.2||||||p-value was calculated using GLM. Statistical significance was determined using an alpha level of 0.05.|general linear model|adjusted for age, sex, education and baseline overall MoCA score||||||0.20
74057637|NCT04196023|147666488|SUPERIORITY|||||||0.9||||||p-value was calculated using GLM model. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.90
74057638|NCT04196023|147666489|SUPERIORITY|||||||0.01||||||p-value was calculated using GLM model. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.01
74057639|NCT04196023|147666490|SUPERIORITY|||||||0.05||||||p-value was calculated using GLM model and false discovery rate (FDR)-adjustment. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.05
74057640|NCT00401726|147666512|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.25||||0.218|||||||Chi-squared|||||||0.218
74057641|NCT00401726|147666513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.76||95.0|-0.92|1.25|||ANCOVA|||||1.25|-0.92|0.76
74057642|NCT00401726|147666514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.148||95.0|-0.41|0.06|||ANCOVA|||||0.06|-0.41|0.148
74057643|NCT00401726|147666515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.829||95.0|-1.09|0.87|||ANCOVA|||||0.87|-1.09|0.829
74057644|NCT00401726|147666516|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.57||||0.728|||||||Chi-squared|||||||0.728
74057645|NCT00401726|147666517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.805||95.0|-2.24|1.74|||ANCOVA|||||1.74|-2.24|0.805
74057646|NCT00401726|147666518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.123||95.0|-2.27|0.27|||ANCOVA|||||0.27|-2.27|0.123
74057647|NCT00401726|147666519|SUPERIORITY_OR_OTHER|||||||0.961|||||||Cochran-Mantel-Haenszel|p-value based on comparison of mean score differences||CGI-I raw scores (range 1-7) analyzed by generalized Cochran-Mantel-Haenszel (CMH) test, stratified by study center using the ridit scoring option.||||0.961
74057648|NCT04246593|147666543|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites. In order to further explore the intervention effect, we fit GLMMs that adjust for (1) baseline dietary intake and (2) race and baseline income.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.52||0.84|TWO_SIDED|||||P-value calculated for the mean difference between the user and non-user groups.|GLMM|||||||0.84
74057649|NCT04246593|147666544|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Median Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|1.15||0.61|TWO_SIDED|||||P-value calculated for the mean difference between change in BMI for intervention and control groups.|GLMM|||||||0.61
74057650|NCT04246593|147666545|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-28.02|STANDARD_ERROR_OF_MEAN|43.31||0.53|TWO_SIDED|||||P-value calculated for the mean difference in change scores between the intervention and control groups.|GLMM|||||||0.53
74057651|NCT04246593|147666546|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|1.65||0.75|TWO_SIDED|||||The p-value applies to the mean difference in mean self-efficacy change scores between the intervention and control groups.|GLMM|||||||0.75
74057652|NCT04246593|147666547|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|1.13||0.63|TWO_SIDED|||||P-value applies to the mean difference in mean total barriers score change between the intervention and control groups.|GLMM|||||||0.63
74057653|NCT02369874|147666554|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7624|TWO_SIDED|95.0|0.85|1.26|||Log Rank|||||1.26|0.85|0.7624
74057654|NCT02369874|147666554|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1993|TWO_SIDED|95.0|0.72|1.08|||Log Rank|||||1.08|0.72|0.1993
74057655|NCT02369874|147666555|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.459|TWO_SIDED|95.0|0.73|1.17|||Log Rank|||||1.17|0.73|0.4590
74057656|NCT02369874|147666555|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.85|1.36||||||||1.36|0.85|
74057657|NCT02369874|147666556|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.63|1.39||||||||1.39|0.63|
74057658|NCT02369874|147666557|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.9|1.33||||||||1.33|0.90|
74057659|NCT02369874|147666557|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.84|1.25||||||||1.25|0.84|
74057660|NCT02369874|147666558|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.67|1.7||||||||1.70|0.67|
74057661|NCT02369874|147666558|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.66|1.68||||||||1.68|0.66|
74057662|NCT02369874|147666560|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.67|1.52||||||6 Month analysis||1.52|0.67|
73881740|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.8262|TWO_SIDED|95.0|-1.02|0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.81|-1.02|0.8262
74057663|NCT02369874|147666560|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.64|1.46||||||6 Month analysis||1.46|0.64|
74057664|NCT02369874|147666560|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.72|1.75||||||12 Month analysis||1.75|0.72|
74057665|NCT02369874|147666560|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.63|1.57||||||12 Month analysis||1.57|0.63|
74057666|NCT02369874|147666563|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.76|1.21||||||||1.21|0.76|
74057667|NCT02369874|147666564|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.74|2.39||||||||2.39|0.74|
74057668|NCT01049360|147666579|SUPERIORITY_OR_OTHER||Least square mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.156|0.245||Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate|Mixed Models Analysis|||||0.245|0.156|<0.0001
74057669|NCT01049360|147666579|SUPERIORITY_OR_OTHER||Least square mean difference|0.202|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.158|0.245|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.245|0.158|<0.0001
74057670|NCT01049360|147666580|SUPERIORITY_OR_OTHER||Least square mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.083|0.181|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.181|0.083|<0.0001
74057671|NCT01049360|147666580|SUPERIORITY_OR_OTHER||Least squares mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.088|0.185|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.185|0.088|<0.0001
74057672|NCT01049360|147666581|SUPERIORITY_OR_OTHER||Least squares mean difference|0.281|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.23|0.333|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.333|0.230|<0.0001
74057673|NCT01049360|147666581|SUPERIORITY_OR_OTHER||Least squares mean difference|0.275|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.224|0.325|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.325|0.224|<0.0001
74057674|NCT00620191|147666597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.7|STANDARD_DEVIATION|1.92||0.05|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.05
74101070|NCT02933255|147751860|OTHER|||||||0.129||||||The reported p-value is representative of changes in IL-10 at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.129
73881741|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3152|TWO_SIDED|95.0|-0.6|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.19|-0.60|0.3152
74057675|NCT00620191|147666597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.1|STANDARD_DEVIATION|1.36||0.05|TWO_SIDED||||||ANCOVA|adjusted for baseline ADAS-Cog value|The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.05
74057676|NCT00620191|147666598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.98|STANDARD_DEVIATION|1.01||0.06|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.06
74057677|NCT00620191|147666598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|0.91||0.34|TWO_SIDED||||||ANCOVA|adjusted for baseline ADAS-Cog score.|The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.34
74057678|NCT00620191|147666599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|2.14||0.36|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.36
74057679|NCT00620191|147666600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.09|STANDARD_DEVIATION|4.73||0.34|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.34
74057680|NCT05510297|147666601|SUPERIORITY||Median Difference (Net)|7.0||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
74057681|NCT05510297|147666602|SUPERIORITY||Mean Difference (Final Values)|2653.16|STANDARD_DEVIATION|5110.86||0.074|TWO_SIDED|95.0|-297.76522|5604.07522||a priori threshold for statistical significance=0.05 for 2-sided t-test; no adjustments for multiple comparisons made; data were checked for normality using the Shapiro-Wilk test where p\>0.05 was interpreted as likely normal distribution.|t-test, 2 sided|||||5604.07522|-297.76522|0.074
74057682|NCT05510297|147666603|SUPERIORITY|a priori threshold for statistical significance=0.05 for 2-sided t-test; no adjustments for multiple comparisons made;|Mean Difference (Net)|4.44067|STANDARD_DEVIATION|41.59009||0.685|TWO_SIDED|95.0|-18.59116|27.47249|||t-test, 2 sided|||||27.47249|-18.59116|0.685
74057683|NCT05510297|147666604|SUPERIORITY||Mean Difference (Net)|-0.51267|STANDARD_DEVIATION|1.44656||0.191|TWO_SIDED|95.0|-1.31374|0.28841|||t-test, 2 sided|||||0.28841|-1.31374|0.191
74057684|NCT05510297|147666605|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_DEVIATION|1.35026||0.218|TWO_SIDED|95.0|-1.19775|0.29775|||t-test, 2 sided|||||0.29775|-1.19775|0.218
74057685|NCT05510297|147666606|SUPERIORITY||Mean Difference (Net)|-0.924|STANDARD_DEVIATION|2.19396||0.125|TWO_SIDED|95.0|-2.13898|0.29098|||t-test, 2 sided|||||0.29098|-2.13898|0.125
74057686|NCT05510297|147666607|SUPERIORITY||Mean Difference (Net)|0.00133|STANDARD_DEVIATION|0.10148||0.96|TWO_SIDED|95.0|-0.05486|0.5753|||t-test, 2 sided|||||0.5753|-0.05486|0.960
74057687|NCT05510297|147666611|SUPERIORITY||Mean Difference (Net)|-0.622|STANDARD_DEVIATION|1.6553||0.168|TWO_SIDED|95.0|-1.53867|0.29467|||t-test, 2 sided|||||0.29467|-1.53867|0.168
74057688|NCT02389621|147666654|SUPERIORITY||Difference|36.7|||<|0.0001|TWO_SIDED|95.0|24.9|48.5||Statistical tests were performed at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted using the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||48.5|24.9|<0.0001
74057689|NCT02389621|147666655|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|34.8|||<|0.0001|TWO_SIDED|95.0|22.8|46.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||46.8|22.8|<0.0001
74057690|NCT02389621|147666656|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|52.5|||<|0.0001|TWO_SIDED|95.0|42.0|62.9|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||62.9|42.0|<0.0001
74057691|NCT02389621|147666657|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.||||||0.0002|||||||van Elteren test|van Elteren test stratified by platelet transfusion during the study.||||||0.0002
74057692|NCT02389621|147666658|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
74057693|NCT01005810|147666699|SUPERIORITY||Odds Ratio (OR)|2.35||||0.029|TWO_SIDED|95.0|1.05|5.24|||Regression, Logistic|||||5.24|1.05|0.029
74057694|NCT04359758|147666709|SUPERIORITY|||||||0.14|||||||Chi-squared|||The study was powered assuming 10% genetic testing uptake UC compared to 35% in ST. assuming these uptake rates and a two-tailed alpha of 0.05, a sample size of n=50 per arm would yield greater than 80% power.||||0.14
74057695|NCT04359758|147666709|SUPERIORITY||Odds Ratio (OR)|2.57||||0.039|TWO_SIDED|95.0|1.05|6.29|||Regression, Logistic|||Because education and marital status have been associated with genetic testing participation in prior research, we conducted a follow-up analysis in which we adjusted for education and marital status.||6.29|1.05|0.039
74057696|NCT04359758|147666710|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|101 degrees of freedom.||||||0.13
74057697|NCT04359758|147666711|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|df=102||||||0.78
74057698|NCT04359758|147666712|SUPERIORITY|||||||0.97|||||||ANCOVA|df = 1, 101||Analysis of PROMIS anxiety||||0.97
74057699|NCT04359758|147666712|SUPERIORITY|||||||0.34|||||||ANCOVA|df = 1, 101||Analysis of PROMIS Depression||||0.34
74057700|NCT04753606|147666802|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
74057701|NCT04753606|147666802|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
74057702|NCT04753606|147666803|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
74057703|NCT04753606|147666803|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
74057704|NCT04753606|147666804|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
74057705|NCT04753606|147666804|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
74057706|NCT04753606|147666805|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
74057707|NCT04753606|147666805|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
74057708|NCT04753606|147666806|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
74057709|NCT04753606|147666806|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
74057710|NCT04753606|147666807|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
74057711|NCT04753606|147666807|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
74057712|NCT04753606|147666808|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
74057713|NCT04753606|147666808|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
74057714|NCT04753606|147666809|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
74057715|NCT04753606|147666809|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
74057716|NCT04753606|147666810|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
74057717|NCT04753606|147666810|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
74057718|NCT04753606|147666811|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
74057719|NCT04753606|147666811|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
74057720|NCT04753606|147666812|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
74057721|NCT04753606|147666812|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
74057722|NCT04753606|147666813|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
74101071|NCT02933255|147751862|OTHER|||||||0.339||||||The reported p-value is representative of changes in CD4+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
74057723|NCT04753606|147666813|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
74057724|NCT04753606|147666814|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
74057725|NCT04753606|147666814|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
74057726|NCT04753606|147666815|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
74057727|NCT04753606|147666815|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
74057728|NCT04753606|147666816|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
74057729|NCT04753606|147666816|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
74057730|NCT00489411|147666817|SUPERIORITY_OR_OTHER||Mean Difference|0.73||||0.003|TWO_SIDED|95.0|0.26|1.2|||Wilcoxon (Mann-Whitney)|||||1.20|0.26|0.003
74057731|NCT00489411|147666818|SUPERIORITY_OR_OTHER||Mean Difference|4.4|||||TWO_SIDED|95.0|0.93|7.88||||||||7.88|0.93|
74057732|NCT00489411|147666819|SUPERIORITY_OR_OTHER||Mean Difference|1.58||||0.03|TWO_SIDED|95.0|0.15|3.0|||Wilcoxon (Mann-Whitney)|||||3.00|0.15|0.03
74057733|NCT00489411|147666820|SUPERIORITY_OR_OTHER||Mean difference|1.01|||||TWO_SIDED|95.0|0.36|1.65||||||||1.65|0.36|
74057734|NCT01283009|147666821|SUPERIORITY||Odds Ratio (OR)|0.9||||0.635|TWO_SIDED|95.0|0.58|1.4|||Mantel Haenszel|||||1.40|0.58|0.635
74057735|NCT04436497|147666822|SUPERIORITY||Disease Rate Ratio|1.08|STANDARD_DEVIATION|0.11|||TWO_SIDED|95.0|0.874|1.307||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. zilucoplan slowed progression) was 0.2418. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by zilucoplan relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.307|0.874|
74057736|NCT04436497|147666824|SUPERIORITY||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|1.819||0.5495|TWO_SIDED|95.0|-4.66|2.48|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Zilucoplan 24-week change from baseline relative to placebo 24-week change from baseline.|||2.48|-4.66|0.5495
74057737|NCT04436497|147666825|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|3.409||0.7602|TWO_SIDED|95.0|-7.73|5.65|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Zilucoplan 24-week change from baseline relative to placebo 24-week change from baseline.|||5.65|-7.73|0.7602
74057738|NCT04436497|147666826|SUPERIORITY|||||||0.6891|||||||Log Rank|||||||0.6891
74057739|NCT00505765|147666830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|1.5||0.21|TWO_SIDED||||||ANCOVA|||||||0.21
74057740|NCT00505765|147666830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.5||0.44|TWO_SIDED||||||ANCOVA|||||||0.44
74057741|NCT03841331|147666835|SUPERIORITY||Treatment Effect|-1.4||||0.5861|TWO_SIDED|95.0|-13.9|11.1|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used|At Week 10||11.1|-13.9|0.5861
74057742|NCT03841331|147666836|SUPERIORITY||Treatment Effect|-0.7||||0.5651|TWO_SIDED|95.0|-10.1|8.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 2||8.7|-10.1|0.5651
74101072|NCT02933255|147751862|OTHER|||||||0.037||||||The reported p-value is representative of changes in CD4+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.037
73881742|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4399|TWO_SIDED|95.0|-0.56|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.24|-0.56|0.4399
74057743|NCT03841331|147666836|SUPERIORITY||Treatment Effect|-4.1||||0.7769|TWO_SIDED|95.0|-14.8|6.7|||Cochran-Mantel-Haenszel|||At Week 4|95% Wald confidence intervals for the treatment difference was used.|6.7|-14.8|0.7769
74101073|NCT02933255|147751862|OTHER|||||||0.009||||||The reported p-value is representative of changes in CD4+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.009
74057744|NCT03841331|147666836|SUPERIORITY||Treatment Effect|2.8||||0.3285|TWO_SIDED|95.0|-9.1|14.8|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 6||14.8|-9.1|0.3285
74057745|NCT03841331|147666836|SUPERIORITY||Treatment Effect|-2.3||||0.6525|TWO_SIDED|95.0|-14.4|9.8|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 8||9.8|-14.4|0.6525
74057746|NCT03841331|147666837|SUPERIORITY||Treatment effect|0.0||||0.4952|TWO_SIDED|95.0|-5.6|5.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 2||5.7|-5.6|0.4952
74057747|NCT03841331|147666837|SUPERIORITY||Treatment effect|5.2||||0.0891|TWO_SIDED|95.0|-2.3|12.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 4||12.7|-2.3|0.0891
74057748|NCT03841331|147666837|SUPERIORITY||Treatment effect|-4.2||||0.8447|TWO_SIDED|95.0|-12.1|3.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 6||3.7|-12.1|0.8447
74057749|NCT03841331|147666837|SUPERIORITY||Treatment effect|1.0||||0.4174|TWO_SIDED|95.0|-7.5|9.4|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 8||9.4|-7.5|0.4174
74101074|NCT02933255|147751862|OTHER|||||||0.844||||||The reported p-value is representative of changes in CD4+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.844
74057750|NCT03841331|147666837|SUPERIORITY||Treatment effect|2.7||||0.2756|TWO_SIDED|95.0|-5.8|11.2|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 10||11.2|-5.8|0.2756
74101075|NCT02933255|147751862|OTHER|||||||0.204||||||The reported p-value is representative of changes in CD8+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.204
74057751|NCT03841331|147666838|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4409|TWO_SIDED|95.0|-0.49|0.57|||ANOVA|||At Week 2||0.57|-0.49|0.4409
74057752|NCT03841331|147666838|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.5496|TWO_SIDED|95.0|-0.65|0.57||At week 4|ANOVA|||At Week 4||0.57|-0.65|0.5496
74057753|NCT03841331|147666838|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.6311|TWO_SIDED|95.0|-0.78|0.55|||ANOVA|||At Week 6||0.55|-0.78|0.6311
74057754|NCT03841331|147666838|SUPERIORITY||Mean Difference (Final Values)|0.4738||||0.02|TWO_SIDED|95.0|-0.65|0.69|||ANOVA|||At Week 8||0.69|-0.65|0.02
74057755|NCT03841331|147666838|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.3948|TWO_SIDED|95.0|-0.6|0.78|||ANOVA|||At Week 10||0.78|-0.60|0.3948
74101076|NCT02933255|147751862|OTHER|||||||0.084||||||The reported p-value is representative of changes in CD8+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
74101077|NCT02933255|147751862|OTHER|||||||0.042||||||The reported p-value is representative of changes in CD8+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.042
74101078|NCT02933255|147751862|OTHER|||||||0.688||||||The reported p-value is representative of changes in CD8+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.688
73881743|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1898|TWO_SIDED|95.0|-0.67|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.13|-0.67|0.1898
74057756|NCT03841331|147666840|SUPERIORITY||Mean Difference (Final Values)|2.44||||0.244|TWO_SIDED|95.0|-4.98|9.87|||ANOVA|||At Week 2||9.87|-4.98|0.2440
74057757|NCT03841331|147666840|SUPERIORITY||Mean Difference (Final Values)|-1.27||||0.6349|TWO_SIDED|95.0|-9.2|6.65|||ANOVA|||At Week 4||6.65|-9.20|0.6349
74057758|NCT03841331|147666840|SUPERIORITY||Mean Difference (Final Values)|0.3407||||1.91|TWO_SIDED|95.0|-6.4|10.23|||ANOVA|||At Week 6||10.23|-6.40|1.91
74057759|NCT03841331|147666840|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.496|TWO_SIDED|95.0|-8.52|8.97|||ANOVA|||At Week 10||8.97|-8.52|0.4960
74057760|NCT02743117|147666843|SUPERIORITY_OR_OTHER||Rate Difference|-1.3|||||TWO_SIDED|95.0|-8.1|1.3||||||||1.3|-8.1|
74057761|NCT02743117|147666844|SUPERIORITY_OR_OTHER||Rate Difference|-8.2|||||TWO_SIDED|95.0|-22.2|4.6||||||Up to Day 8||4.6|-22.2|
74057762|NCT02743117|147666844|SUPERIORITY_OR_OTHER||Rate Difference|-7.4|||||TWO_SIDED|95.0|-21.6|5.9||||||Up to Day 15||5.9|-21.6|
74057763|NCT01207219|147666848|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The p-value for statistical significance in these analyses was 0.01 adjusted for multiple comparisons .|Mixed Models Analysis|mixed-model analysis with a repeated-measures approach including an unstructured variance matrix||Data analysis was based on the Intention-to-Treatment (ITT) method. Differences between the three intervention groups over time (baseline and 12 weeks) were assessed with a Group x Time interaction term. A priori comparisons of the active intervention groups with the waitlist group were carried out with the same strategy if analyses including all the three groups meet the criterion of statistical significance (P\<0.01).||||<0.01
74101079|NCT02933255|147751862|OTHER||||||<|0.001||||||The reported p-value is representative of changes in Treg cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
74057764|NCT00694070|147666853|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 80%, with n=51, critical number is 38. With this critical value and sample size, the power to reject Ho is approximately 87.43%."||||||0.0421|||||||Exact binomial test|||||||0.0421
74057765|NCT00694070|147666854|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 95%, with n=51, critical number is 47. With this critical value and sample size, the power to reject Ho is approximately 88.96%."||||||0.0309|||||||Exact binomial test|||||||0.0309
74057766|NCT00694070|147666855|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 90%, with n=51, critical number is 43. With this critical value and sample size, the power to reject Ho is approximately 93.57%."||||||0.0309|||||||Exact binomial test|||||||0.0309
74057767|NCT01453296|147666872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.8|5.7|||||Day 1 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-0.8|
74057768|NCT01453296|147666872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-2.4|3.7|||||Day 14 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.7|-2.4|
74057769|NCT01453296|147666872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.6|3.6|||||Day 14 maximum HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.6|-2.6|
74057770|NCT01453296|147666873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.8|5.7|||||Day 1 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-0.8|
74057771|NCT01453296|147666873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-2.4|3.7|||||Day 14 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.7|-2.4|
74057772|NCT01453296|147666873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.6|3.6|||||Day 14 weighted HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.6|-2.6|
74057773|NCT01453296|147666874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-4.5|6.6|||||Day 1 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.6|-4.5|
74057774|NCT01453296|147666874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|-3.2|6.3|||||Day 14 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.3|-3.2|
74057775|NCT01453296|147666874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-3.0|5.7|||||Day 14 maximum QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-3.0|
74057776|NCT01453296|147666888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.01|||||TWO_SIDED|95.0|-2.59|6.61|||||Day 1 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.61|-2.59|
74057777|NCT01453296|147666888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94|||||TWO_SIDED|95.0|-1.93|7.81|||||Day 14 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||7.81|-1.93|
74057778|NCT01453296|147666888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||||TWO_SIDED|95.0|-0.7|7.08|||||Day 14 weighted QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||7.08|-0.70|
74057779|NCT00766727|147666889|SUPERIORITY||Mean Difference (Final Values)|-31.88|STANDARD_DEVIATION|14.25|||TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||
74057780|NCT03948646|147666913|OTHER||Odds Ratio (OR)|2.0||||0.0029|TWO_SIDED|95.0|1.27|3.15|||Regression, Logistic|||||3.15|1.27|0.0029
74057781|NCT03948646|147666914|OTHER||Mean Difference (Net)|-21.77|STANDARD_ERROR_OF_MEAN|9.994||0.0296|TWO_SIDED|95.0|-41.37|-2.16|||ANCOVA|||||-2.16|-41.37|0.0296
74057782|NCT00276458|147666924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|2.7|<|0.001||95.0|-25.2|-14.5|||ANCOVA|Model terms: treatment and baseline LDL-C value|(Atorva + EZ minus Atorva)|||-14.5|-25.2|<0.001
74057783|NCT00276458|147666925|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|2.1||0.273||95.0|-1.9|6.6|||ANCOVA|Model terms: treatment and baseline HDL-C value|(Atorva + EZ minus Atorva)|||6.6|-1.9|0.273
74057784|NCT00276458|147666926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0|-21.2|-11.7|||ANCOVA|Model terms: treatment and baseline non-HDL-C value|(Atorva + EZ minus Atorva)|||-11.7|-21.2|<0.001
74057785|NCT00276458|147666927|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-15.8|-8.6|||ANCOVA|Model terms: treatment and baseline Total-C value|(Atorva + EZ minus Atorva)|||-8.6|-15.8|<0.001
74101080|NCT02933255|147751862|OTHER|||||||0.733||||||The reported p-value is representative of changes in Treg cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.733
74101081|NCT02933255|147751862|OTHER|||||||0.519||||||The reported p-value is representative of changes in Treg cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.519
74101082|NCT02933255|147751862|OTHER|||||||0.695||||||The reported p-value is representative of changes in Treg cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.695
74101083|NCT02933255|147751862|OTHER|||||||0.034||||||The reported p-value is representative of changes in cDC cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.034
74101084|NCT02933255|147751862|OTHER|||||||0.301||||||The reported p-value is representative of changes in cDC cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.301
74057786|NCT00276458|147666928|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.9||||0.159||95.0|-17.7|-0.4||ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value|Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.~(Atorva + EZ minus Atorva)"|||-0.4|-17.7|0.159
74057787|NCT00276458|147666929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.1|<|0.001||95.0|-17.8|-9.6|||ANCOVA|Model terms: treatment and baseline Apo B value|(Atorva + EZ minus Atorva)|||-9.6|-17.8|<0.001
74057788|NCT00276458|147666930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.6||0.681||95.0|-3.9|2.6|||ANCOVA|Model terms: treatment and baseline Apo A-I value|(Atorva + EZ minus Atorva)|||2.6|-3.9|0.681
74057789|NCT00276458|147666931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0|-17.5|-8.7|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value|(Atorva + EZ minus Atorva)|||-8.7|-17.5|<0.001
74057790|NCT00276458|147666932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.001||95.0|-26.5|-15.3|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value|(Atorva + EZ minus Atorva)|||-15.3|-26.5|<0.001
74057791|NCT00276458|147666933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0|-17.9|-8.3|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value|(Atorva + EZ minus Atorva)|||-8.3|-17.9|<0.001
74057792|NCT00276458|147666934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|3.0|<|0.001||95.0|-23.2|-11.4|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value|(Atorva + EZ minus Atorva)|||-11.4|-23.2|<0.001
74057793|NCT00276458|147666935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.841||95.0|-23.8|28.8|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment|"Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.~(Atorva + EZ minus Atorva)"|||28.8|-23.8|0.841
74057794|NCT00276458|147666936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.3||||0.839||95.0|-26.1|8.3|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline CRP value|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.~(Atorva + EZ minus Atorva)"|||8.3|-26.1|0.839
74057795|NCT00276458|147666937|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.6|||<|0.001||95.0|3.8|19.47|||Regression, Logistic|Model terms: treatment and baseline LDL-C value|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva + EZ versus Atorva.|||19.47|3.80|<0.001
74057796|NCT00750373|147666944|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1|||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||We estimated that a sample size of 74 patients would provide 80% power to detect a significant difference with respect to the primary end point at the 2-sided significance level of 0.05, assuming that the in-hospital event rate would be 23% in the conventional treatment group and 3% in the early surgery group.||||<0.05
74057797|NCT02276274|147666995|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0592|0.0264|||||Analysis of variance (ANOVA) was performed on log-transformed values of AUC (0-72) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0264|-0.0592|
74057798|NCT02276274|147666996|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0592|0.0264|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0264|-0.0592|
74057799|NCT02276274|147666997|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1182|||||TWO_SIDED|90.0|-0.0405|0.2769|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.2769|-0.0405|
74057800|NCT02276274|147666999|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0139|||||TWO_SIDED|90.0|-0.0598|0.032|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0320|-0.0598|
74057801|NCT02276274|147667014|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.014|||||TWO_SIDED|90.0|-0.0918|0.0638|||||ANOVA was performed on log-transformed values of AUC (0-48) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0638|-0.0918|
74057802|NCT02276274|147667015|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0934|0.0605|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0605|-0.0934|
74057803|NCT02276274|147667017|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1518|||||TWO_SIDED|90.0|-0.2356|-0.068|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||-0.0680|-0.2356|
74057804|NCT02276274|147667019|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0179|||||TWO_SIDED|90.0|-0.095|0.0591|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0591|-0.0950|
74057805|NCT00480077|147667055|SUPERIORITY|The primary end point of the study, all-cause death or hospitalization for heart failure, was analyzed on a time-to-first-event basis with the log-rank test. The hazard ratio (HR) associated with allocation to the access arm relative to control was estimated with corresponding 95% confidence interval (CI) by fitting a Cox proportional hazards model containing the treatment group as a categorical factor.||||||0.063|||||||Log Rank|||||||0.063
74101085|NCT02933255|147751862|OTHER|||||||0.38||||||The reported p-value is representative of changes in cDC cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.38
74101086|NCT02933255|147751862|OTHER|||||||0.014||||||The reported p-value is representative of changes in cDC cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.014
74101087|NCT02933255|147751862|OTHER|||||||0.791||||||The reported p-value is representative of changes in monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.791
74057806|NCT01683565|147667101|OTHER|Analyses compared the change in Pervasive Developmental Disorders Screening Test-II scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.67||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The sample size was determined based on the goal of confirming trial feasibility and estimating effect sizes for a full-scale trial, not for a definitive test of efficacy. The enrollment goal was 40, which would have provided an indication of an expected effect size for a larger full-scale trial (e.g., 53% power to detect a 2-point decrease (approximately 0.7-SD based on a prior study) in Pervasive Developmental Disorders Screening Test-II score). Funding limitations capped enrollment at 31.||||0.67
74057807|NCT01683565|147667102|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.22||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Competence scores between groups (LCPUFA vs. Placebo).||||0.22
74057808|NCT01683565|147667102|OTHER|Analyses compared the change in the BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes||||||0.92||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Problem scores between groups (LCPUFA vs. Placebo).||||0.92
74057809|NCT01683565|147667102|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.88|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Dysregulation scores between groups (LCPUFA vs. Placebo).||||0.88
74057810|NCT01683565|147667102|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.23|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Externalizing scores between groups (LCPUFA vs. Placebo).||||0.23
74057811|NCT01683565|147667102|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.91|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Internalizing scores between groups (LCPUFA vs. Placebo).||||0.91
74057812|NCT01683565|147667102|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.03|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Austism Spectrum Disorder scores between groups (LCPUFA vs. Placebo).||||0.03
74057813|NCT01683565|147667102|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.07|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Red Flag scores between groups (LCPUFA vs. Placebo).||||0.07
73881744|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.9791|TWO_SIDED|95.0|-0.4|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.41|-0.40|0.9791
73881745|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3178|TWO_SIDED|95.0|-0.61|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.20|-0.61|0.3178
74057814|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.31||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (10:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.31
74057815|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.47||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (12:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.47
73881746|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4174|TWO_SIDED|95.0|-0.57|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.24|-0.57|0.4174
74057816|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.38||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (14:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.38
74057817|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
74057818|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.16||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:1n-7 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.16
74057819|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
74057820|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:1n-9 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
73888195|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|22.6||||0.0006|TWO_SIDED|95.0|9.8|35.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.5|9.8|0.0006
74101088|NCT02933255|147751862|OTHER|||||||0.042||||||The reported p-value is representative of changes in monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
74101089|NCT02933255|147751862|OTHER|||||||0.424||||||The reported p-value is representative of changes in monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
74101090|NCT02933255|147751862|OTHER|||||||0.77||||||The reported p-value is representative of changes in monocytes at week 10 post treatment compared to baseline in the lead-in neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.77
74101091|NCT02933255|147751862|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
74101092|NCT02933255|147751862|OTHER|||||||0.105||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.105
74101093|NCT02933255|147751862|OTHER|||||||0.622||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.622
74101094|NCT02933255|147751862|OTHER|||||||0.313||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.313
74101095|NCT02933255|147751862|OTHER||||||<|0.001||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
74101096|NCT02933255|147751862|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
74101097|NCT02933255|147751862|OTHER|||||||0.47||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.47
74101098|NCT02933255|147751862|OTHER|||||||0.313||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.313
74101099|NCT02933255|147751862|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
74101100|NCT02933255|147751862|OTHER|||||||0.092||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.092
74101101|NCT02933255|147751862|OTHER|||||||0.176||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.176
74101102|NCT02933255|147751862|OTHER|||||||0.232||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.232
74101103|NCT02933255|147751862|OTHER||||||<|0.001||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
74101104|NCT02933255|147751862|OTHER|||||||0.131||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.131
74101105|NCT02933255|147751862|OTHER|||||||0.424||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
74057821|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.21||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:2n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.21
74057822|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.34||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.34
74057823|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.24||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.24
74101106|NCT02933255|147751862|OTHER|||||||0.438||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.438
74101107|NCT02933255|147751862|OTHER||||||<|0.001||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
74101108|NCT02933255|147751862|OTHER|||||||0.151||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.151
74101109|NCT02933255|147751862|OTHER|||||||0.569||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.569
74057824|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.5||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:4n-3 nmol/mL ) between groups (LCPUFA vs. Placebo).||||0.50
74057825|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.07||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.07
74057826|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:4n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.10
74057827|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.001
74057828|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.71||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.71
74057829|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:6n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.001
74057830|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (Total Omega-6) between groups (LCPUFA vs. Placebo).||||0.10
74057831|NCT01683565|147667103|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (total omega-3) between groups (LCPUFA vs. Placebo).||||0.10
74057832|NCT05261126|147667105|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-41.2|||<|0.001|TWO_SIDED|95.0|-47.8|-34.7|||cLDA||MK-0616 6 mg minus Placebo|||-34.7|-47.8|<0.001
74057833|NCT05261126|147667105|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-55.7|||<|0.001|TWO_SIDED|95.0|-62.3|-49.1|||cLDA||MK-0616 12 mg minus Placebo|||-49.1|-62.3|<0.001
74057834|NCT05261126|147667105|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-59.1|||<|0.001|TWO_SIDED|95.0|-65.7|-52.5|||cLDA||MK-0616 18 mg minus Placebo|||-52.5|-65.7|<0.001
74057835|NCT05261126|147667105|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-60.9|||<|0.001|TWO_SIDED|95.0|-67.6|-54.3|||cLDA||MK-0616 30 mg minus Placebo|||-54.3|-67.6|<0.001
74101110|NCT02933255|147751862|OTHER|||||||0.105||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.105
74101111|NCT02933255|147751862|OTHER|||||||0.012||||||The reported p-value is representative of changes in NK ki67+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.012
74101112|NCT02933255|147751862|OTHER|||||||0.677||||||The reported p-value is representative of changes in NK ki67+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.677
74101113|NCT02933255|147751862|OTHER|||||||0.424||||||The reported p-value is representative of changes in NK ki67+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
74101114|NCT02933255|147751862|OTHER|||||||0.432||||||The reported p-value is representative of changes in NK ki67+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.432
74101115|NCT02933255|147751862|OTHER|||||||0.016||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.016
73881747|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.249|TWO_SIDED|95.0|-0.63|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.16|-0.63|0.2490
74057836|NCT05261126|147667106|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|0.2|||||TWO_SIDED|95.0|-15.5|15.8|||||MK-0616 6 mg minus Placebo|||15.8|-15.5|
73888196|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|96.1|||<|0.0001|TWO_SIDED|95.0|57.9|134.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||134.2|57.9|<0.0001
74057837|NCT05261126|147667106|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-4.5|||||TWO_SIDED|95.0|-20.0|11.2|||||MK-0616 12 mg vs Placebo|||11.2|-20.0|
74057838|NCT05261126|147667106|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-0.6|||||TWO_SIDED|95.0|-16.3|15.1|||||MK-0616 18 mg vs Placebo|||15.1|-16.3|
74057839|NCT05261126|147667106|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-1.9|||||TWO_SIDED|95.0|-17.5|13.8|||||MK-0616 30 mg minus Placebo|||13.8|-17.5|
74057840|NCT05261126|147667108|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-32.8|||<|0.001|TWO_SIDED|95.0|-38.6|-26.9|||cLDA||MK-0616 6 mg minus Placebo|||-26.9|-38.6|<0.001
74057841|NCT05261126|147667108|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-45.8|||<|0.001|TWO_SIDED|95.0|-51.7|-39.9|||cLDA||MK-0616 12 mg minus Placebo|||-39.9|-51.7|<0.001
74057842|NCT05261126|147667108|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-48.7|||<|0.001|TWO_SIDED|95.0|-54.6|-42.8|||cLDA||MK-0616 18 mg minus Placebo|||-42.8|-54.6|<0.001
74057843|NCT05261126|147667108|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Square Means|-51.8|||<|0.001|TWO_SIDED|95.0|-57.7|-45.9|||cLDA||MK-0616 30 mg minus Placebo|||-45.9|-57.7|<0.001
74057844|NCT05261126|147667109|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-35.9|||<|0.001|TWO_SIDED|95.0|-42.4|-29.4|||cLDA||MK-0616 6 mg minus Placebo|||-29.4|-42.4|<0.001
74057845|NCT05261126|147667109|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-50.5|||<|0.001|TWO_SIDED|95.0|-57.0|-44.0|||cLDA||MK-0616 12 mg minus Placebo|||-44.0|-57.0|<0.001
74057846|NCT05261126|147667109|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-53.2|||<|0.001|TWO_SIDED|95.0|-59.7|-46.7|||cLDA||MK-0616 18 mg minus Placebo|||-46.7|-59.7|<0.001
74057847|NCT05261126|147667109|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-55.8|||<|0.001|TWO_SIDED|95.0|-62.3|-49.3|||cLDA||MK-0616 30 mg minus Placebo|||-49.3|-62.3|<0.001
74057848|NCT05261126|147667110|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|69.2|||<|0.001|TWO_SIDED|95.0|56.2|79.0|||Miettinen & Nurminen||MK-0616 6 mg minus Placebo|||79.0|56.2|<0.001
74057849|NCT05261126|147667110|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|75.2|||<|0.001|TWO_SIDED|95.0|62.9|84.0|||Miettinen & Nurminen method||MK-0616 12 mg minus Placebo|||84.0|62.9|<0.001
74057850|NCT05261126|147667110|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|79.2|||<|0.001|TWO_SIDED|95.0|67.1|87.1|||Miettinen & Nurminen method||MK-0616 18 mg minus Placebo|||87.1|67.1|<0.001
74057851|NCT05261126|147667110|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|79.5|||<|0.001|TWO_SIDED|95.0|67.9|87.4|||Miettinen & Nurminen method||MK-0616 30 mg minus Placebo|||87.4|67.9|<0.001
74057852|NCT03671746|147667128|SUPERIORITY||Median Difference (Final Values)|1.5|STANDARD_DEVIATION|1.5|=|0.275|TWO_SIDED||||||ANOVA|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed using Length of Stay (LOS) as this was the primary outcome. Using a significance level of 0.05 and assumed standard deviation of 1.5 days, a sample size of 42 patients/group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was planned for 56 patients/group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||=0.275
74057853|NCT03671746|147667129|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed using LOS as this was the primary outcome. Using a significance level of 0.05 and an assumed standard deviation of 1.5 days, a sample size of 42 patients/group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients/group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||<0.05
74057854|NCT03671746|147667130|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|The VAS model was adjusted for baseline levels as a covariate, which differed significantly between groups.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||<0.05
74057855|NCT03671746|147667131|SUPERIORITY||||||=|0.564|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.564
74057856|NCT03671746|147667132|SUPERIORITY||||||=|0.118|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.118
74057857|NCT03671746|147667133|SUPERIORITY|||||||0.215|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||0.215
74101116|NCT02933255|147751862|OTHER|||||||0.733||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.733
74101117|NCT02933255|147751862|OTHER|||||||0.519||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.519
73881748|NCT03192176|147297635|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.87||0.1233|TWO_SIDED|95.0|-6.57|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||0.79|-6.57|0.1233
74101118|NCT02933255|147751862|OTHER|||||||0.557||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.557
74101119|NCT02933255|147751862|OTHER|||||||0.034||||||The reported p-value is representative of changes in NK NKp46+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.034
74101120|NCT02933255|147751862|OTHER|||||||0.092||||||The reported p-value is representative of changes in NK NKp46+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.092
74057858|NCT03671746|147667134|SUPERIORITY||||||=|0.043|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.043
74101121|NCT02933255|147751862|OTHER|||||||0.733||||||The reported p-value is representative of changes in NK NKp46+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.733
74101122|NCT02933255|147751862|OTHER|||||||0.922||||||The reported p-value is representative of changes in NK NKp46+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.922
74101123|NCT02933255|147751862|OTHER|||||||0.176||||||The reported p-value is representative of changes in CD8+ naive T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.176
74101124|NCT02933255|147751862|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD8+ naive T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
74101125|NCT02933255|147751862|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD8+ naive T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
74101126|NCT02933255|147751862|OTHER|||||||0.563||||||The reported p-value is representative of changes in CD8+ naive T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.563
74101127|NCT02933255|147751862|OTHER|||||||0.012||||||The reported p-value is representative of changes in CD8+ CM T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.012
74101128|NCT02933255|147751862|OTHER|||||||0.084||||||The reported p-value is representative of changes in CD8+ CM T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
74101129|NCT02933255|147751862|OTHER|||||||0.016||||||The reported p-value is representative of changes in CD8+ CM T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.016
74101130|NCT02933255|147751862|OTHER|||||||0.688||||||The reported p-value is representative of changes in CD8+ CM T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.688
74101131|NCT02933255|147751862|OTHER|||||||0.38||||||The reported p-value is representative of changes in gMDSC at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.38
74101132|NCT02933255|147751862|OTHER|||||||0.021||||||The reported p-value is representative of changes in gMDSC at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.021
74101133|NCT02933255|147751862|OTHER|||||||0.91||||||The reported p-value is representative of changes in gMDSC at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.91
74101134|NCT02933255|147751862|OTHER|||||||0.084||||||The reported p-value is representative of changes in gMDSC at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
74101135|NCT02933255|147751862|OTHER|||||||0.151||||||The reported p-value is representative of changes in intermediate monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.151
74101136|NCT02933255|147751862|OTHER|||||||0.042||||||The reported p-value is representative of changes in intermediate monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
74101137|NCT02933255|147751862|OTHER|||||||0.424||||||The reported p-value is representative of changes in intermediate monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
74101138|NCT02933255|147751862|OTHER|||||||0.846||||||The reported p-value is representative of changes in intermediate monocytes at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.846
74101139|NCT02933255|147751862|OTHER|||||||0.339||||||The reported p-value is representative of changes in non-classical monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
74101140|NCT02933255|147751862|OTHER|||||||0.012||||||The reported p-value is representative of changes in non-classical monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.012
74101141|NCT02933255|147751862|OTHER|||||||0.622||||||The reported p-value is representative of changes in non-classical monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.622
74101142|NCT02933255|147751862|OTHER|||||||0.492||||||The reported p-value is representative of changes in non-classical monocytes at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.492
74057859|NCT03671746|147667135|SUPERIORITY||||||=|0.617|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.617
74057860|NCT03671746|147667137|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||<0.05
74057861|NCT05966129|147667179|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.7957|TWO_SIDED|95.0|-18.3|23.8|||t-test, 2 sided||||Confidence Interval Width = 42.1|23.8|-18.3|0.7957
74057862|NCT05966129|147667180|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8255|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided||||Confidence Interval Width = 0.9|0.5|-0.4|0.8255
74057863|NCT05966129|147667181|SUPERIORITY|||||||0.9054|||||||Wilcoxon (Mann-Whitney)|||||||0.9054
74057864|NCT05966129|147667182|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.248|TWO_SIDED|95.0|-1.9|0.5|||t-test, 2 sided||||Confidence Interval Width = 2.4|0.5|-1.9|0.248
74057865|NCT05966129|147667183|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.6012|TWO_SIDED|95.0|-2.7|4.7|||t-test, 2 sided||||Confidence Interval Width = 7.4|4.7|-2.7|0.6012
74057866|NCT05966129|147667184|SUPERIORITY|||||||0.7528|||||||Chi-squared|||||||0.7528
74057867|NCT05966129|147667185|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
74057868|NCT01375491|147667187|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||See published paper.|ANOVA|See published paper.||See published paper.||||<0.05
74057869|NCT02207413|147667212|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (D-QIV\_LP/ D-QIV\_IP) is ≤ 1.5.|Adjusted GMT Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/ Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.11|0.85|
74057870|NCT02207413|147667212|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.05|||||TWO_SIDED|95.0|0.94|1.18|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.18|0.94|
74101143|NCT02933255|147751862|OTHER|||||||0.11||||||The reported p-value is representative of changes in CD4+ CM T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.11
74101144|NCT02933255|147751862|OTHER|||||||0.02||||||The reported p-value is representative of changes in CD4+ CM T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.02
74057871|NCT02207413|147667212|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5|Adjusted GMT Ratio|1.03|||||TWO_SIDED|95.0|0.91|1.16|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.16|0.91|
73881749|NCT03192176|147297635|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.9||0.2858|TWO_SIDED|95.0|-5.76|1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.70|-5.76|0.2858
74057872|NCT02207413|147667212|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.04|||||TWO_SIDED|95.0|0.9|1.21|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.21|0.90|
74057873|NCT02207413|147667213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT ratio|1.07|||||TWO_SIDED|95.0|0.9|1.28|||ANCOVA|||The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.28|0.90|
74057874|NCT02207413|147667213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5|Adjusted GMT Ratio|1.18|||||TWO_SIDED|95.0|1.0|1.39|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.39|1.00|
74057875|NCT02207413|147667213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.27|||ANCOVA|||The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.27|0.91|
74057876|NCT02207413|147667213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.17|||||TWO_SIDED|95.0|0.99|1.38|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate||1.38|0.99|
74057877|NCT01683331|147667237|SUPERIORITY||Odds Ratio (OR)|1.03||||0.87|TWO_SIDED|95.0|1.01|1.06|||Chi-squared|||||1.06|1.01|0.87
74057878|NCT01683331|147667238|SUPERIORITY||Odds Ratio (OR)|1.3||||0.92|TWO_SIDED|95.0|1.2|2.8|||Chi-squared|||||2.8|1.2|0.92
74057879|NCT05981365|147667250|OTHER||Ratio of Geometric LS Means|1.2629|||||TWO_SIDED|90.0|1.1673|1.3663||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3663|1.1673|
74057880|NCT05981365|147667250|OTHER||Ratio of Geometric LS Means|1.1845|||||TWO_SIDED|95.0|1.0758|1.3042||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3042|1.0758|
74057881|NCT05981365|147667251|OTHER||Ratio of Geometric LS Means|1.1929|||||TWO_SIDED|90.0|1.0215|1.393||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3930|1.0215|
74057882|NCT05981365|147667252|OTHER||Ratio of Geometric LS Means|1.1311|||||TWO_SIDED|90.0|1.0496|1.2189||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2189|1.0496|
73881750|NCT03192176|147297635|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.93||0.9716|TWO_SIDED|95.0|-3.87|3.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||3.73|-3.87|0.9716
74057883|NCT05981365|147667253|OTHER||Ratio of Geometric LS Means|0.8228||||||90.0|0.6992|0.9683||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9683|0.6992|
74057884|NCT05981365|147667254|OTHER||Ratio of Geometric LS Means|1.5738|||||TWO_SIDED|90.0|1.4523|1.7054||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.7054|1.4523|
74057885|NCT05981365|147667255|OTHER||Ratio of Geometric LS Means|1.1491|||||TWO_SIDED|90.0|1.0807|1.222||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2220|1.0807|
74057886|NCT05981365|147667255|OTHER||Ratio of Geometric LS Means|0.9494|||||TWO_SIDED|90.0|0.8759|1.0291||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.0291|0.8759|
74057887|NCT05981365|147667256|OTHER||Ratio of Geometric LS Means|1.3316|||||TWO_SIDED|90.0|1.2558|1.4121||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.4121|1.2558|
74057888|NCT05981365|147667257|OTHER||Ratio of Geometric LS Means|1.1282|||||TWO_SIDED|90.0|1.07|1.1896||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1896|1.0700|
73881751|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|1.93||0.9072|TWO_SIDED|95.0|-3.58|4.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||4.03|-3.58|0.9072
74057889|NCT05981365|147667258|OTHER||Ratio of Geometric LS Means|0.8047|||||TWO_SIDED|90.0|0.7173|0.9027||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9027|0.7173|
74057890|NCT05981365|147667259|OTHER||Ratio of Geometric LS Means|2.0611|||||TWO_SIDED|90.0|1.8789|2.2609||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||2.2609|1.8789|
74057891|NCT05981365|147667260|OTHER||Ratio of Geometric LS Means|1.1374|||||TWO_SIDED|90.0|1.0672|1.2122||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2122|1.0672|
74057892|NCT05981365|147667260|OTHER||Ratio of Geometric LS Means|0.9371|||||TWO_SIDED|90.0|0.8643|1.0162||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.0162|0.8643|
74057893|NCT05981365|147667261|OTHER||Ratio of Geometric LS Means|1.2713|||||TWO_SIDED|90.0|1.1939|1.3538||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3538|1.1939|
74057894|NCT05981365|147667262|OTHER||Ratio of Geometric LS Means|1.127|||||TWO_SIDED|90.0|1.0688|1.1883||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1883|1.0688|
74057895|NCT05981365|147667263|OTHER||Ratio of Geometric LS Means|0.7973|||||TWO_SIDED|90.0|0.7039|0.9031||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9031|0.7039|
74057896|NCT05981365|147667264|OTHER||Ratio of Geometric LS Means|2.026|||||TWO_SIDED|90.0|1.8496|2.2193||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||2.2193|1.8496|
74057897|NCT05981365|147667265|OTHER||Ratio of Geometric LS Means|0.7909|||||TWO_SIDED|90.0|0.716|0.8737||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8737|0.7160|
74057898|NCT05981365|147667266|OTHER||Ratio of Geometric LS Means|1.0831|||||TWO_SIDED|90.0|0.9723|1.2065||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2065|0.9723|
74057899|NCT05981365|147667267|OTHER||Ratio of Geometric LS Means|1.3138|||||TWO_SIDED|90.0|1.1871|1.4541||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.4541|1.1871|
74057900|NCT05981365|147667268|OTHER||Ratio of Geometric LS Means|0.7958|||||TWO_SIDED|90.0|0.742|0.8534||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8534|0.7420|
74057901|NCT05981365|147667269|OTHER||Ratio of Geometric LS Means|1.0322|||||TWO_SIDED|90.0|0.9531|1.1179||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1179|0.9531|
74057902|NCT05981365|147667270|OTHER||Ratio of Geometric LS Means|1.1975|||||TWO_SIDED|90.0|1.0972|1.3069||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3069|1.0972|
74057903|NCT05981365|147667271|OTHER||Ratio of Geometric LS Means|0.8018|||||TWO_SIDED|90.0|0.7472|0.8604||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8604|0.7472|
74057904|NCT05981365|147667272|OTHER||Ratio of Geometric LS Means|1.063|||||TWO_SIDED|90.0|0.9888|1.1427||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1427|0.9888|
74057905|NCT05981365|147667273|OTHER||Ratio of Geometric LS Means|1.2197|||||TWO_SIDED|90.0|1.1114|1.3385||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3385|1.1114|
74057906|NCT04640168|147667344|SUPERIORITY|||||||0.909|||||||Chi-squared|||||||0.909
74057907|NCT04640168|147667361|SUPERIORITY||Risk Difference (RD)|7.7|||||TWO_SIDED|95.0|1.8|13.4||||||||13.4|1.8|
74057908|NCT04640168|147667362|SUPERIORITY||Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-4.3|5.5||||||||5.5|-4.3|
74057909|NCT04640168|147667380|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.27||||||||1.27|0.80|
74057910|NCT04640168|147667381|SUPERIORITY||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.09|0.02||||||||0.02|-0.09|
74057911|NCT04640168|147667382|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.94|1.23||||||||1.23|0.94|
74057912|NCT04640168|147667383|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.94|1.23||||||||1.23|0.94|
74057913|NCT04640168|147667384|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
74057914|NCT00620776|147667390|SUPERIORITY_OR_OTHER|||||||0.17|||||||Mixed Models Analysis|||Mixed model analysis (differential slopes over time) comparing the 26 patients who received combined treatment with at least one CBT session to the 35 patients randomized to venlafaxine XR alone (and received at least one dose) on HAM-A total scores. Only available scores were used (no imputation for missing data). Because the HAM-A demonstrated a relatively rapid improvement early in treatment and then a leveling off, a shifted log-transformation of time of assessment was implemented.||||.17
74057915|NCT00620776|147667391|SUPERIORITY_OR_OTHER|||||||0.54|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.54
74057916|NCT00620776|147667392|SUPERIORITY_OR_OTHER|||||||0.86|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.86
74057917|NCT00620776|147667393|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANCOVA|||Data collected at week 24 were analyzed using analysis of covariance (ANCOVA) with the baseline score as the covariate.||||.051
74057918|NCT00620776|147667394|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.06
74057919|NCT00620776|147667395|SUPERIORITY_OR_OTHER|||||||0.95|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.95
74057920|NCT00620776|147667396|SUPERIORITY_OR_OTHER|||||||0.17|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.||||.17
74057921|NCT00620776|147667397|SUPERIORITY_OR_OTHER|||||||0.53|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.||||.53
74057922|NCT00620776|147667398|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA with baseline data as covariate.||||.23
74057923|NCT00620776|147667399|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA including baseline data as covariate.||||.07
74057924|NCT00620776|147667400|SUPERIORITY_OR_OTHER|||||||0.63|||||||Chi-squared|||||||.63
74057925|NCT00620776|147667401|SUPERIORITY_OR_OTHER|||||||0.52|||||||Chi-squared|||||||.52
74057926|NCT03992456|147667443|SUPERIORITY|||||||0.5126|||||||Un-Stratified Log-rank|||||||0.5126
74057927|NCT03992456|147667444|SUPERIORITY|||||||0.1512|||||||Un-Stratified Log-rank|||||||0.1512
74057928|NCT03992456|147667445|SUPERIORITY|||||||0.2506|||||||Chi-squared|||||||0.2506
74057929|NCT03992456|147667446|SUPERIORITY|||||||0.8865|||||||Chi-squared|||||||0.8865
74057930|NCT03992456|147667447|SUPERIORITY|||||||0.5455|||||||Fisher Exact|||||||0.5455
74057931|NCT04668066|147667520|OTHER||Least Square Mean Difference|5.6||||0.6343|TWO_SIDED|90.0|-21.4|32.6|||ANCOVA|||||32.6|-21.4|0.6343
74057932|NCT01015118|147667594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0239|TWO_SIDED|95.0|0.72|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level Area under curve 5 (AUC5) vs. Area under curve 6 (AUC6).||0.98|0.72|0.0239
74057933|NCT01015118|147667595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0286|TWO_SIDED|95.0|0.75|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.98|0.75|0.0286
73881752|NCT03192176|147297635|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|1.92||0.2334|TWO_SIDED|95.0|-6.07|1.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.49|-6.07|0.2334
73881753|NCT03192176|147297635|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|1.91||0.9859|TWO_SIDED|95.0|-3.79|3.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||3.72|-3.79|0.9859
74057934|NCT01015118|147667596|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0186|TWO_SIDED|95.0|0.72|0.97|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.97|0.72|0.0186
74057935|NCT01015118|147667597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0256|TWO_SIDED|95.0|0.74|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.98|0.74|0.0256
73881754|NCT03192176|147297635|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.9||0.287|TWO_SIDED|95.0|-5.77|1.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.72|-5.77|0.2870
73881755|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1632|TWO_SIDED|95.0|-1.41|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.24|-1.41|0.1632
74057936|NCT01015118|147667598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8653|TWO_SIDED|95.0|0.83|1.17|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.17|0.83|0.8653
74057937|NCT01015118|147667599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0749|TWO_SIDED|95.0|0.77|1.01|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.01|0.77|0.0749
74057938|NCT01015118|147667600|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.349|TWO_SIDED|95.0|0.81|1.82|||Regression, Logistic||An odds ratio \>1 favours nintedanib.|Odds ratio and p-value are obtained from logistic regression model adjusting for, macroscopic residual postoperative tumour (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.82|0.81|0.3490
74057939|NCT01015118|147667601|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.29|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|3.88|6.69|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference presented is the Adjusted mean difference. Difference calculated as nintedanib minus placebo. High values represent a worse level of symptoms.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).||6.69|3.88|<0.0001
74057940|NCT01015118|147667602|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|0.75||0.0124|TWO_SIDED|95.0|-3.35|-0.41|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference calculated is the Adjusted mean. High values represent a better level of functioning. Difference calculated as nintedanib minus placebo.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).||-0.41|-3.35|0.0124
74057941|NCT03522506|147667603|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The least squares mean (LSM) sleep latency for each treatment and the associated standard error and 95% confidence interval (CI) was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|Least square mean difference|20.06|||<|0.001|TWO_SIDED|95.0|13.35|26.77|||Linear mixed effect model|||||26.77|13.35|<0.001
74057942|NCT03522506|147667603|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|24.35|||<|0.001|TWO_SIDED|95.0|17.64|31.06|||Linear mixed effect model|||||31.06|17.64|<0.001
74101145|NCT02933255|147751862|OTHER|||||||0.052||||||The reported p-value is representative of changes in CD4+ CM T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.052
74101146|NCT02933255|147751862|OTHER|||||||0.844||||||The reported p-value is representative of changes in CD4+ CM T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.844
74101147|NCT02933255|147751862|OTHER||||||>|0.999||||||The reported p-value is representative of changes in CD4+ naive T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||>0.999
74057943|NCT03522506|147667603|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM Difference|19.89|||<|0.001|TWO_SIDED|95.0|13.3|26.49|||Linear mixed effects model|||||26.49|13.30|<0.001
74057944|NCT03522506|147667613|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.2||||0.664|TWO_SIDED|95.0|-1.13|0.73|||Linear mixed effect model|||||0.73|-1.13|0.664
74057945|NCT03522506|147667613|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.24||||0.605|TWO_SIDED|95.0|-0.69|1.17|||Linear mixed effect model|||||1.17|-0.69|0.605
74057946|NCT03522506|147667613|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26||||0.574|TWO_SIDED|95.0|-1.17|0.66|||Linear mixed effect model|||||0.66|-1.17|0.574
74057947|NCT03522506|147667613|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.29||||0.483|TWO_SIDED|95.0|-0.53|1.11|||Linear mixed effect model|||||1.11|-0.53|0.483
74057948|NCT03522506|147667613|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.01||||0.972|TWO_SIDED|95.0|-0.81|0.84|||Linear mixed effect model|||||0.84|-0.81|0.972
74057949|NCT03522506|147667613|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.18||||0.654|TWO_SIDED|95.0|-0.99|0.63|||Linear mixed effect model|||||0.63|-0.99|0.654
74057950|NCT03522506|147667613|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.01||||0.984|TWO_SIDED|95.0|-0.86|0.85|||Linear mixed effect model|||||0.85|-0.86|0.984
74057951|NCT03522506|147667613|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.29||||0.508|TWO_SIDED|95.0|-1.14|0.57|||Linear mixed effect model|||||0.57|-1.14|0.508
74057952|NCT03522506|147667613|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.22||||0.605|TWO_SIDED|95.0|-1.06|0.62|||Linear mixed effect model|||||0.62|-1.06|0.605
74101148|NCT02933255|147751862|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD4+ naive T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
74101149|NCT02933255|147751862|OTHER|||||||0.339||||||The reported p-value is representative of changes in CD4+ naive T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
74101150|NCT02933255|147751862|OTHER||||||>|0.999||||||The reported p-value is representative of changes in CD4+ naive T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||>0.999
74101151|NCT04803305|147751873|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-2.38|1.18|||||Week 4|||1.18|-2.38|
74101152|NCT04803305|147751874|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|-0.75|3.15|||||Week 1|||3.15|-0.75|
74101153|NCT04803305|147751874|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|90.0|-0.28|2.49|||||Week 2|||2.49|-0.28|
74101154|NCT04803305|147751874|SUPERIORITY||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-0.93|2.99|||||Week 3|||2.99|-0.93|
74101155|NCT04803305|147751874|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-2.02|2.02|||||Week 5|||2.02|-2.02|
74101156|NCT04803305|147751874|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.11|1.51|||||Week 6|||1.51|-3.11|
74101157|NCT04803305|147751875|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.98|||TWO_SIDED|90.0|-4.18|3.53|||||Week 1|||3.53|-4.18|
74101158|NCT04803305|147751875|SUPERIORITY||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|90.0|-5.49|1.16|||||Week 2|||1.16|-5.49|
74101159|NCT04803305|147751875|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-0.62|2.06|||||Week 3|||2.06|-0.62|
73881756|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.42||0.0045|TWO_SIDED|95.0|-2.03|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.38|-2.03|0.0045
74057953|NCT03522506|147667613|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.11||||0.847|TWO_SIDED|95.0|-1.06|1.29|||Linear mixed effect model|||||1.29|-1.06|0.847
74057954|NCT03522506|147667613|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.44||||0.455|TWO_SIDED|95.0|-1.61|0.73|||Linear mixed effect model|||||0.73|-1.61|0.455
74057955|NCT03522506|147667613|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.58||||0.317|TWO_SIDED|95.0|-1.74|0.57|||Linear mixed effect model|||||0.57|-1.74|0.317
74057956|NCT03522506|147667613|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.0||||0.001|TWO_SIDED|95.0|-3.18|-0.83|||Linear mixed effect model|||||-0.83|-3.18|0.001
74057957|NCT03522506|147667613|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.61|||<|0.001|TWO_SIDED|95.0|-4.79|-2.44|||Linear mixed effect model|||||-2.44|-4.79|<0.001
74057958|NCT03522506|147667613|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.16|||<|0.001|TWO_SIDED|95.0|-4.32|-2.01|||Linear mixed effect model|||||-2.01|-4.32|<0.001
74057959|NCT03522506|147667613|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.69||||0.003|TWO_SIDED|95.0|-2.78|-0.6|||Linear mixed effect model|||||-0.60|-2.78|0.003
74057960|NCT03522506|147667613|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-4.3|||<|0.001|TWO_SIDED|95.0|-5.39|-3.21|||Linear mixed effect model|||||-3.21|-5.39|<0.001
74057961|NCT03522506|147667613|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.83|||<|0.001|TWO_SIDED|95.0|-4.91|-2.76|||Linear mixed effect model|||||-2.76|-4.91|<0.001
74057962|NCT03522506|147667613|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.71||||0.13|TWO_SIDED|95.0|-1.63|0.21|||Linear mixed effect model|||||0.21|-1.63|0.130
74057963|NCT03522506|147667613|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.32|||<|0.001|TWO_SIDED|95.0|-4.24|-2.4|||Linear mixed effect model|||||-2.40|-4.24|<0.001
74057964|NCT03522506|147667613|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.71|||<|0.001|TWO_SIDED|95.0|-3.62|-1.8|||Linear mixed effect model|||||-1.80|-3.62|<0.001
74057965|NCT03522506|147667613|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26||||0.577|TWO_SIDED|95.0|-1.2|0.68|||Linear mixed effect model|||||0.68|-1.20|0.577
74101160|NCT04803305|147751875|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|90.0|-1.29|2.2|||||Week 4|||2.20|-1.29|
74101161|NCT04803305|147751875|SUPERIORITY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.21|2.57|||||Week 5|||2.57|-1.21|
73888197|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|21.9||||0.253|TWO_SIDED|95.0|-15.8|59.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.7|-15.8|0.2530
74101162|NCT04803305|147751875|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|0.34|3.39|||||Week 6|||3.39|0.34|
74101163|NCT05833139|147751880|OTHER||Geometric mean ratio (T/R) [%]|141.2|||||TWO_SIDED|90.0|126.3|157.7|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 18.0|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. AUC0-∞ was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||157.7|126.3|
74101164|NCT05833139|147751881|OTHER||Geometric mean ratio (T/R) [%]|126.9|||||TWO_SIDED|90.0|106.6|151.0|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 28.7|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. Cmax was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||151.0|106.6|
74101165|NCT05833139|147751882|OTHER||Geometric mean ratio (T/R) [%]|142.8|||||TWO_SIDED|90.0|126.0|161.9|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 20.4|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. AUC0-tz was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||161.9|126.0|
74101166|NCT03922529|147751883|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.543|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5430
74101167|NCT03922529|147751884|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.7625|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7625
74101168|NCT03922529|147751885|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.8842|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8842
74101169|NCT03922529|147751886|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.4086|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4086
74101170|NCT03922529|147751887|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.3841|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.3841
74101171|NCT03922529|147751888|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.2||0.1393|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|||The adjusted difference from a model may not necessarily match the raw difference between groups.|||0.1393
74101172|NCT03922529|147751889|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|12.3||0.9257|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9257
74101173|NCT03922529|147751890|SUPERIORITY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|11.8||0.6588|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6588
74101174|NCT03922529|147751891|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|13.0||0.992|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9920
74101175|NCT03922529|147751892|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9504|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9504
74101176|NCT03922529|147751893|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.6228|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6228
74101177|NCT03922529|147751894|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7966|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7966
74101178|NCT03922529|147751895|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5071|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5071
74101179|NCT03922529|147751896|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5553|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5553
74057966|NCT03522506|147667613|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.26|||<|0.001|TWO_SIDED|95.0|-3.2|-1.32|||Linear mixed effect model|||||-1.32|-3.20|<0.001
74057967|NCT03522506|147667613|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.57|-0.72|||Linear mixed effect model|||||-0.72|-2.57|<0.001
74057968|NCT03522506|147667613|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.31||||0.475|TWO_SIDED|95.0|-0.55|1.16|||Linear mixed effect model|||||1.16|-0.55|0.475
74057969|NCT03522506|147667613|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.14||||0.753|TWO_SIDED|95.0|-0.99|0.72|||Linear mixed effect model|||||0.72|-0.99|0.753
74057970|NCT03522506|147667613|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.99||||0.022|TWO_SIDED|95.0|-1.83|-0.15|||Linear mixed effect model|||||-0.15|-1.83|0.022
74057971|NCT03522506|147667614|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|22.94|||<|0.001|TWO_SIDED|95.0|16.58|29.3|||Linear mixed effect model|||||29.30|16.58|<0.001
74057972|NCT03522506|147667614|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|30.95|||<|0.001|TWO_SIDED|95.0|24.59|37.31|||Linear mixed effects model|||||37.31|24.59|<0.001
74057973|NCT03522506|147667614|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|26.5|||<|0.001|TWO_SIDED|95.0|20.24|32.75|||Linear mixed effect model|||||32.75|20.24|<0.001
74057974|NCT03522506|147667615|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|14.56|||<|0.001|TWO_SIDED|95.0|7.04|22.08|||Linear mixed effect model|||||22.08|7.04|<0.001
74057975|NCT03522506|147667615|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|32.21|||<|0.001|TWO_SIDED|95.0|24.68|39.73|||Linear mixed effect model|||||39.73|24.68|<0.001
74057976|NCT03522506|147667615|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|25.74|||<|0.001|TWO_SIDED|95.0|18.33|33.14|||Linear mixed effect model|||||33.14|18.33|<0.001
74057977|NCT03522506|147667616|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|9.6||||0.003|TWO_SIDED|95.0|3.35|15.85|||Linear mixed effect model|||||15.85|3.35|0.003
74057978|NCT03522506|147667616|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|33.33|||<|0.001|TWO_SIDED|95.0|27.08|39.58|||Linear mixed effect model|||||39.58|27.08|<0.001
74057979|NCT03522506|147667616|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.91|||<|0.001|TWO_SIDED|95.0|10.77|23.06|||Linear mixed effect model|||||23.06|10.77|<0.001
73888198|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|78.6|||<|0.0001|TWO_SIDED|95.0|40.5|116.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||116.8|40.5|<0.0001
74057980|NCT03522506|147667617|SUPERIORITY|An analysis of variance (ANOVA) model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.16||||0.436|TWO_SIDED|95.0|-7.68|3.36|||ANOVA|||||3.36|-7.68|0.436
74057981|NCT03522506|147667617|SUPERIORITY|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.29||||0.409|TWO_SIDED|95.0|-7.81|3.23|||ANOVA|||||3.23|-7.81|0.409
74057982|NCT03522506|147667617|SUPERIORITY|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.77|||<|0.001|TWO_SIDED|95.0|11.37|22.18|||ANOVA|||||22.18|11.37|<0.001
74057983|NCT03480243|147667618|OTHER||Cmax Estimate Ratio|1.9|||||TWO_SIDED|90.0|1.59|2.27|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.27|1.59|
74057984|NCT03480243|147667618|OTHER||Cmax Estimate Ratio|1.81|||||TWO_SIDED|90.0|1.51|2.16|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.16|1.51|
74057985|NCT03480243|147667619|OTHER||AUC Estimate Ratio|1.8|||||TWO_SIDED|90.0|1.5|2.17|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.17|1.50|
74057986|NCT03480243|147667619|OTHER||AUC Estimate Ratio|1.64|||||TWO_SIDED|90.0|1.36|1.97|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||1.97|1.36|
74057987|NCT03480243|147667620|OTHER||Cmax,ss Estimate Ratio|2.13|||||TWO_SIDED|90.0|1.77|2.55|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.55|1.77|
74057988|NCT03480243|147667620|OTHER||Cmax,ss Estimate Ratio|2.13|||||TWO_SIDED|90.0|1.78|2.56|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.56|1.78|
74057989|NCT03480243|147667621|OTHER||AUCtau Estimate Ratio|2.48|||||TWO_SIDED|90.0|2.02|3.03|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||3.03|2.02|
74057990|NCT03480243|147667621|OTHER||AUCtau Estimate Ratio|2.23|||||TWO_SIDED|90.0|1.82|2.73|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.73|1.82|
74057991|NCT00761085|147667646|OTHER|No statistical comparisons||||||||||||||||"No statistical comparisons of methadone concentration in patients receiving methadone vs not receiving methadone (children or adults).~No statistical comparisons of methadone concentration in children vs adults"|No statistical comparisons|||
74057992|NCT00761085|147667647|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74057993|NCT01522755|147667650|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74057994|NCT01522755|147667651|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74057995|NCT01522755|147667652|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74057996|NCT03414658|147667653|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.025|TWO_SIDED|80.0|0.35|0.81|||Log Rank|||||0.81|0.35|0.025
74057997|NCT03414658|147667653|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.32|TWO_SIDED|80.0|0.8|1.64|||Log Rank|||||1.64|0.8|0.32
74057998|NCT02388906|147667657|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0003|TWO_SIDED|95.0|0.6|0.86|||Log Rank|Stratified log rank||||0.86|0.60|0.0003
74057999|NCT02388906|147667658|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.03|0.69|1.11|||Log Rank||Stratified Cox proportional hazard model|||1.11|0.69|
74058000|NCT02388906|147667665|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.63|0.9|||Log Rank|Stratified log rank||||0.90|0.63|
74058001|NCT04365387|147667667|OTHER||Cochran-Mantel-Haenszel|2.1|||||TWO_SIDED|90.0|-10.3|14.5|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using Cochran-Mantel-Haenszel (CMH).|||14.5|-10.3|
74058002|NCT04365387|147667668|OTHER||Cochran-Mantel-Haenszel|-4.6|||||TWO_SIDED|90.0|-14.9|5.7|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||5.7|-14.9|
74058003|NCT04365387|147667670|OTHER||Cochran-Mantel-Haenszel|1.4|||||TWO_SIDED|90.0|-3.2|5.9|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||5.9|-3.2|
74058004|NCT04365387|147667671|OTHER||Cochran-Mantel-Haenszel|13.3|||||TWO_SIDED|90.0|0.1|26.4|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH for non-Imputed values|||26.4|0.1|
74058005|NCT04365387|147667672|OTHER||Cochran-Mantel-Haenszel|1.3|||||TWO_SIDED|90.0|-9.3|11.9|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||11.9|-9.3|
74058006|NCT05770401|147667673|SUPERIORITY||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|1.227||0.014|TWO_SIDED|95.0|0.72|5.76|||ANCOVA|||The null hypothesis was there would be no significant difference in LCQ total score change from baseline to one-week post-treatment between groups.||5.76|.72|.014
74058007|NCT05770401|147667674|SUPERIORITY||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|8.804||0.056|TWO_SIDED|95.0|-32.7|0.46|||ANCOVA|||The null hypothesis was there would be no significant difference in Cough Severity VAS Scores from baseline to one-week post-treatment between groups.||0.46|-32.7|.056
73881757|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.42||0.0002|TWO_SIDED|95.0|-2.43|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.77|-2.43|0.0002
74058008|NCT03901274|147667700|SUPERIORITY||Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.74|0.42|||||Parameter estimated with full information maximum likelihood|Intent-to-treat on three month outcomes with intake (i.e. Pretest covariate)||0.42|-0.74|
73881758|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.7|-1.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-1.02|-2.70|<0.0001
73888199|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|39.3||||0.0414|TWO_SIDED|95.0|1.6|77.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||77.1|1.6|0.0414
74058009|NCT03901274|147667700|SUPERIORITY||Slope|-0.65|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-1.2|-0.09|||||Parameter estimated with full information maximum likelihood|Intent-to-treat on six month outcomes with intake (i.e. Pretest covariate)||-0.09|-1.20|
74058010|NCT00145119|147667721|SUPERIORITY_OR_OTHER_LEGACY||proportion (%)|8.0||||||||||||||||||
73881759|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.42||0.8569|TWO_SIDED|95.0|-0.91|0.76||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.76|-0.91|0.8569
74101180|NCT03922529|147751897|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1194|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.1194
74101181|NCT03922529|147751898|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.8||0.9012|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9012
74101182|NCT03922529|147751899|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.9||0.4279|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4279
74101183|NCT03922529|147751900|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.8||0.1932|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.1932
74101184|NCT03922529|147751901|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.2||0.2723|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2723
74101185|NCT03922529|147751902|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|1.2||0.8951|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8951
74101186|NCT03922529|147751903|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.2||0.2574|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2574
74058011|NCT04957979|147667768|SUPERIORITY||Mean Difference (Net)|-1.6||||0.19|TWO_SIDED|95.0|-4.1|0.1||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Negative value represents smaller change in Medical/Social clinics as compared to Medical/Nursing.|Null hypothesis: Average change in composite care quality outcome is not different between patients receiving care in Medical/Nursing Model clinics and those receiving care in Medical/Social Model clinics.||0.1|-4.1|0.19
74058012|NCT04957979|147667768|SUPERIORITY||Mean Difference (Net)|-3.3||||0.005|TWO_SIDED|95.0|-5.6|-1.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Negative value represents smaller change in Medical/Social clinics as compared to Medical/Nursing.|Null hypothesis: Average change in composite care quality outcome is not different between patients receiving care in Medical/Nursing Model clinics and those receiving care in Medical/Social Model clinics.||-1.0|-5.6|0.005
74058013|NCT04957979|147667769|SUPERIORITY||Incidence Rate Ratio|1.28||||0.02|TWO_SIDED|95.0|1.04|1.58||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.58|1.04|0.02
74058014|NCT04957979|147667769|SUPERIORITY||Incidence Rate Ratio|1.09||||0.45|TWO_SIDED|95.0|0.868|1.38||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.38|0.868|0.45
74058015|NCT04957979|147667770|SUPERIORITY||Incidence Rate Ratio|1.35||||0.01|TWO_SIDED|95.0|1.08|1.69||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.69|1.08|0.01
74058016|NCT04957979|147667770|SUPERIORITY||Incidence Rate Ratio|1.33||||0.08|TWO_SIDED|95.0|0.969|1.81||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.81|0.969|0.08
74058017|NCT04957979|147667771|SUPERIORITY||Odds Ratio (OR)|0.64||||0.0001|TWO_SIDED|95.0|0.51|0.81||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||0.81|0.51|0.0001
74058018|NCT04957979|147667771|SUPERIORITY||Odds Ratio (OR)|1.2||||0.32|TWO_SIDED|95.0|0.84|1.72||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.72|0.84|0.32
74058019|NCT04957979|147667772|SUPERIORITY||Odds Ratio (OR)|0.85||||0.14|TWO_SIDED|95.0|0.69|1.05||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.05|0.69|0.14
74058020|NCT04957979|147667772|SUPERIORITY||Odds Ratio (OR)|0.74||||0.12|TWO_SIDED|95.0|0.51|1.08||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.08|0.51|0.12
74101187|NCT03922529|147751904|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.0||0.8307|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8307
74101188|NCT03922529|147751905|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.0||0.614|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6140
74101189|NCT03922529|147751906|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.0||0.7327|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7327
74101190|NCT03922529|147751907|SUPERIORITY|||||||0.7651|||||||Wilcoxon rank sum|||||||0.7651
73881760|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.42||0.111|TWO_SIDED|95.0|-1.49|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.15|-1.49|0.1110
74058021|NCT04957979|147667773|SUPERIORITY||Odds Ratio (OR)|1.086||||0.914|TWO_SIDED|95.0|0.243|4.861||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||4.861|0.243|0.914
74058022|NCT04957979|147667773|SUPERIORITY||Odds Ratio (OR)|1.009||||0.987|TWO_SIDED|95.0|0.327|3.114||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||3.114|0.327|0.987
74058023|NCT04957979|147667774|SUPERIORITY||Odds Ratio (OR)|1.257||||0.204|TWO_SIDED|95.0|0.883|1.79||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.79|0.883|0.204
74058024|NCT04957979|147667774|SUPERIORITY||Odds Ratio (OR)|0.399||||0.04|TWO_SIDED|95.0|0.166|0.958|||Mixed Models Analysis|||||0.958|0.166|0.04
74058025|NCT04957979|147667775|SUPERIORITY||Odds Ratio (OR)|1.257||||0.302|TWO_SIDED|95.0|0.814|1.939||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.939|0.814|0.302
74058026|NCT04957979|147667775|SUPERIORITY||Odds Ratio (OR)|0.84||||0.192|TWO_SIDED|95.0|0.647|1.092||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.092|0.647|0.192
74058027|NCT04957979|147667776|SUPERIORITY||Odds Ratio (OR)|0.438||||0.318|TWO_SIDED|95.0|0.086|2.22||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||2.22|0.086|0.318
74058028|NCT04957979|147667776|SUPERIORITY||Odds Ratio (OR)|1.793||||0.421|TWO_SIDED|95.0|0.433|7.426||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||7.426|0.433|0.421
74058029|NCT04957979|147667777|SUPERIORITY||Odds Ratio (OR)|0.906||||0.632|TWO_SIDED|95.0|0.606|1.356||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.356|0.606|0.632
74058030|NCT04957979|147667777|SUPERIORITY||Odds Ratio (OR)|0.845||||0.492|TWO_SIDED|95.0|0.523|1.366||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.366|0.523|0.492
74058031|NCT04957979|147667778|SUPERIORITY||Odds Ratio (OR)|0.856||||0.405|TWO_SIDED|95.0|0.594|1.234||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.234|0.594|0.405
74058032|NCT04957979|147667778|SUPERIORITY||Odds Ratio (OR)|0.559||||0.004|TWO_SIDED|95.0|0.374|0.834|||Mixed Models Analysis|||||0.834|0.374|0.004
73881761|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42||0.0187|TWO_SIDED|95.0|-1.83|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.17|-1.83|0.0187
74058033|NCT04957979|147667779|SUPERIORITY||Odds Ratio (OR)|0.151||||0.071|TWO_SIDED|95.0|0.02|1.173||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.173|0.02|0.071
74058034|NCT04957979|147667779|SUPERIORITY||Mean Difference (Net)|0.023||||0.003|TWO_SIDED|95.0|0.002|0.268||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||0.268|0.002|0.003
74058035|NCT04957979|147667780|SUPERIORITY||Odds Ratio (OR)|0.884||||0.557|TWO_SIDED|95.0|0.587|1.333||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.333|0.587|0.557
74058036|NCT04957979|147667780|SUPERIORITY||Mean Difference (Net)|0.624||||0.069|TWO_SIDED|95.0|0.376|1.037||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.037|0.376|0.069
74058037|NCT04957979|147667781|SUPERIORITY||Odds Ratio (OR)|0.539||||0.256|TWO_SIDED|95.0|0.185|1.565||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.565|0.185|0.256
74058038|NCT04957979|147667781|SUPERIORITY||Odds Ratio (OR)|1.117||||0.866|TWO_SIDED|95.0|0.308|4.047||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||4.047|0.308|0.866
73881762|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4972|TWO_SIDED|95.0|-0.73|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.36|-0.73|0.4972
74058039|NCT04957979|147667782|SUPERIORITY||Odds Ratio (OR)|0.797||||0.641|TWO_SIDED|95.0|0.307|2.069||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||2.069|0.307|0.641
74058040|NCT04957979|147667782|SUPERIORITY||Odds Ratio (OR)|0.569||||0.32|TWO_SIDED|95.0|0.187|1.729||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.729|0.187|0.32
74058041|NCT04957979|147667783|SUPERIORITY||Risk Difference (RD)|9.3|||<|0.001|TWO_SIDED|95.0|5.6|13.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||13|5.6|<.001
74058042|NCT04957979|147667783|SUPERIORITY||Risk Difference (RD)|11.0||||0.002|TWO_SIDED|95.0|4.2|18.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher proportion of responders in Medical/Nursing clinics as compared to Medical/Social.|||18|4.2|0.002
74058043|NCT04957979|147667784|SUPERIORITY||Risk Difference (RD)|6.0||||0.023|TWO_SIDED|95.0|0.86|11.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||11.0|0.86|0.023
74058044|NCT04957979|147667784|SUPERIORITY||Risk Difference (RD)|-3.7||||0.5|TWO_SIDED|95.0|-14.0|7.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher proportion of responders in Medical/Nursing clinics as compared to Medical/Social.|||7.0|-14.0|0.5
74058045|NCT04957979|147667785|SUPERIORITY||Mean Difference (Net)|0.13|||<|0.001|TWO_SIDED|95.0|0.06|0.19||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Positive values reflect higher/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||0.19|0.06|<0.001
74058046|NCT04957979|147667785|SUPERIORITY||Mean Difference (Net)|0.19|||<|0.001|TWO_SIDED|95.0|0.06|0.32||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Positive values reflect higher/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||0.32|0.06|<0.001
74058047|NCT04957979|147667786|SUPERIORITY||Mean Difference (Net)|-0.11|||<|0.001|TWO_SIDED|95.0|-0.16|-0.06|||t-test, 2 sided|No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.06|-0.16|<0.001
74101191|NCT03922529|147751908|SUPERIORITY||Incident Rate Ratio|1.15||||0.3974|TWO_SIDED|95.0|0.83|1.59|||Negative binomial regression models|||||1.59|0.83|0.3974
74058048|NCT04957979|147667786|SUPERIORITY||Mean Difference (Net)|-0.11||||0.006|TWO_SIDED|95.0|-0.2|-0.03|||t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.03|-0.2|0.006
74058049|NCT04957979|147667787|SUPERIORITY||Risk Difference (RD)|-2.4||||0.059|TWO_SIDED|95.0|-4.9|0.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared|||||0.00|-4.9|0.059
74058050|NCT04957979|147667787|SUPERIORITY||Risk Difference (RD)|-5.7||||0.014|TWO_SIDED|95.0|-10.0|-1.3||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-1.3|-10.0|0.014
74058051|NCT04957979|147667788|SUPERIORITY||Risk Difference (RD)|11.0|||<|0.001|TWO_SIDED|95.0|6.8|15.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared|||||15.0|6.8|<0.001
74058052|NCT04957979|147667788|SUPERIORITY||Risk Difference (RD)|12.0||||0.001|TWO_SIDED|95.0|4.7|20.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||20.0|4.7|0.001
74058053|NCT04957979|147667789|SUPERIORITY||Mean Difference (Net)|-7.6|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-5|-10|<.001
74058054|NCT04957979|147667789|SUPERIORITY||Mean Difference (Net)|-6.0||||0.007|TWO_SIDED|95.0|-10.0|-2.0|||t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-2|-10|0.007
74058055|NCT04957979|147667790|SUPERIORITY||Risk Difference (RD)|-2.5||||0.046|TWO_SIDED|95.0|-4.8|-0.14||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.14|-4.8|0.046
74058056|NCT04957979|147667790|SUPERIORITY||Risk Difference (RD)|-4.5||||0.033|TWO_SIDED|95.0|-8.4|-0.52||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.52|-8.4|0.033
74058057|NCT04957979|147667791|SUPERIORITY||Risk Difference (RD)|-10.0|||<|0.001|TWO_SIDED|95.0|-13.0|-6.8||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-6.8|-13.0|<0.001
74058058|NCT04957979|147667791|SUPERIORITY||Risk Difference (RD)|-11.0|||<|0.001|TWO_SIDED|95.0|-17.0|-5.6||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-5.6|-17.0|<0.001
74058059|NCT04957979|147667792|SUPERIORITY||Risk Difference (RD)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.0|-4.1||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-4.1|-10.0|<0.001
74058060|NCT04957979|147667792|SUPERIORITY||Risk Difference (RD)|-8.2||||0.002|TWO_SIDED|95.0|-13.0|-3.2||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social|||-3.2|-13.0|0.002
74058061|NCT04957979|147667793|SUPERIORITY||Risk Difference (RD)|-3.4||||0.002|TWO_SIDED|95.0|-5.5|-1.4||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-1.4|-5.5|0.002
74058062|NCT04957979|147667793|SUPERIORITY||Risk Difference (RD)|-2.4||||0.3|TWO_SIDED|95.0|-6.1|1.4||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||1.4|-6.1|0.3
74058063|NCT04411641|147667822|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.693||||0.0026|TWO_SIDED|95.0|0.546|0.88||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation.Covariates were treatment group,age at screening (\>40,\<=40 years),geographic region (United States \[US\], non-US),baseline EDSS score \& baseline gadolinium (Gd)-enhancing T1 lesions (presence, absence).In this analysis, for participants who completed study with 3-month confirmation and continued to meet disability progression criteria throughout EOS, their 6-month CDP status was imputed via multiple imputation method.||0.880|0.546|0.0026
74058064|NCT04411641|147667823|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.757||||0.0134|TWO_SIDED|95.0|0.607|0.944||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||0.944|0.607|0.0134
73888200|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|28.9||||0.1329|TWO_SIDED|95.0|-8.9|66.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||66.6|-8.9|0.1329
74101192|NCT03922529|147751909|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.5||0.2727|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2727
74101193|NCT03922529|147751910|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.5||0.4269|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4269
74101194|NCT03922529|147751911|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.6||0.4354|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4354
74101195|NCT03922529|147751912|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.8695|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8695
74101196|NCT03922529|147751913|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.7075|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7075
74101197|NCT03922529|147751914|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8936|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8936
74101198|NCT03922529|147751915|SUPERIORITY|||||||0.2794|||||||Chi-squared|||||||0.2794
74101199|NCT03922529|147751916|SUPERIORITY|||||||0.6177|||||||Chi-squared|||||||0.6177
74101200|NCT03922529|147751917|SUPERIORITY|||||||0.144|||||||Chi-squared|||||||0.1440
74101201|NCT03922529|147751918|SUPERIORITY|||||||0.1122|||||||Chi-squared|||||||0.1122
74101202|NCT03922529|147751919|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9653|TWO_SIDED|95.0|0.63|1.62|||Regression, Logistic|||||1.62|0.63|0.9653
74101203|NCT03785600|147751931|OTHER||||||<|0.02||||||a priori threshold is \<0.05.|t-test, 2 sided|||||||<0.02
74101204|NCT02567435|147751932|SUPERIORITY||3-Year EFS|65.8||||0.44|TWO_SIDED||||||Log Rank|||||||0.44
74101205|NCT02567435|147751933|SUPERIORITY||3-Year OS|78.2||||0.56|TWO_SIDED||||||Log Rank|||||||0.56
74101206|NCT03765788|147751938|SUPERIORITY||Odds Ratio (OR)|9.31|||||TWO_SIDED|95.0|3.54|26.29|||||Odd Ratio (posterior median) median and 95% credibility interval calculated using the Bayesian inference|Odds Ratio||26.29|3.54|
74101207|NCT04856930|147751951|SUPERIORITY||Least Square (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.25||0.7841|TWO_SIDED|90.0|-2.42|1.73||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|Linear repeated measures model (LRMM)|||||1.73|-2.42|0.7841
74101208|NCT04856930|147751951|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.25||0.2885|TWO_SIDED|90.0|-0.74|3.4||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||3.40|-0.74|0.2885
74101209|NCT04856930|147751952|SUPERIORITY||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|8.97||0.5939|TWO_SIDED|90.0|-19.66|10.07||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||10.07|-19.66|0.5939
74101210|NCT04856930|147751952|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.95||0.7002|TWO_SIDED|90.0|-11.38|18.29||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||18.29|-11.38|0.7002
74101211|NCT04856930|147751953|SUPERIORITY||Risk Difference (RD)|5.3|||||TWO_SIDED|90.0|-13.3|23.4|||||Estimate parameter and 90% CI was based on Unadjusted Risk Difference and exact unconditional confidence intervals (CI).|||23.4|-13.3|
74101212|NCT04856930|147751953|SUPERIORITY||Risk Difference (RD)|3.3|||||TWO_SIDED|90.0|-14.6|21.0|||||Estimate parameter and 90% C was based on Unadjusted Risk Difference and exact unconditional CIs.|||21.0|-14.6|
74101213|NCT04856930|147751954|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7282|TWO_SIDED|90.0|-1.08|0.7||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||0.70|-1.08|0.7282
74101214|NCT04856930|147751954|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.54||0.5019|TWO_SIDED|90.0|-1.25|0.53||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||0.53|-1.25|0.5019
74101215|NCT04856930|147751955|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.49||0.7698|TWO_SIDED|90.0|-0.96|0.67||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||0.67|-0.96|0.7698
74058065|NCT04411641|147667824|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Relative Risk|0.622||||0.011|TWO_SIDED|95.0|0.432|0.897||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Derived using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score, and baseline number of T2 lesions as covariates, and log transformed observation duration as the offset variable.||0.897|0.432|0.0110
74058066|NCT04411641|147667825|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.972||||0.8428|TWO_SIDED|95.0|0.735|1.286||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||1.286|0.735|0.8428
74058067|NCT04411641|147667826|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.767||||0.004|TWO_SIDED|95.0|0.64|0.919|||Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||0.919|0.640|0.0040
74058068|NCT04411641|147667827|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|1.882||||0.0206|TWO_SIDED|95.0|1.102|3.214|||Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||3.214|1.102|0.0206
74058069|NCT04411641|147667828|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|LS Mean Difference|0.082||||0.1646|TWO_SIDED|95.0|-0.034|0.197|||Mixed model repeated measures (MMRM)|||Covariates in the mixed-effect model with repeated measures were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), visit, treatment-by-visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.197|-0.034|0.1646
74058070|NCT03810417|147667839|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
74101216|NCT04856930|147751955|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.7468|TWO_SIDED|90.0|-0.97|0.65||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||0.65|-0.97|0.7468
74058071|NCT03810417|147667839|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
74058072|NCT04410991|147667841|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|0.996||||0.9758|TWO_SIDED|95.0|0.754|1.315||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Analysis was performed using negative binomial model with number of adjudicated relapses onset between randomization date and EOS date as the response variable, treatment group, Gadolinium (Gd)-enhancing T1 lesions at baseline (presence, absence), expanded disability status scale (EDSS) strata (\<4, \>=4) and geographic region (United States \[US\], non-US) as covariates, and log transformed observation duration as the offset variable.||1.315|0.754|0.9758
74058073|NCT04410991|147667842|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.582||||0.0114|TWO_SIDED|95.0|0.38|0.891||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||0.891|0.380|0.0114
74058074|NCT04410991|147667843|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.641||||0.0181|TWO_SIDED|95.0|0.444|0.925||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||0.925|0.444|0.0181
74101217|NCT04856930|147751956|SUPERIORITY||LS Mean Difference|-25.7|STANDARD_ERROR_OF_MEAN|23.46||0.275|TWO_SIDED|90.0|-64.57|13.14||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||13.14|-64.57|0.2750
74101218|NCT04856930|147751956|SUPERIORITY||LS Mean Difference|-21.2|STANDARD_ERROR_OF_MEAN|23.81||0.3757|TWO_SIDED|90.0|-60.6|18.28||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||18.28|-60.60|0.3757
74101219|NCT04856930|147751957|SUPERIORITY||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|13.04||0.6146|TWO_SIDED|90.0|-28.22|15.05||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||15.05|-28.22|0.6146
74058075|NCT04410991|147667844|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.165||||0.2362|TWO_SIDED|95.0|0.905|1.502|||Chi-squared|||Analysis was performed using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, baseline T2-hyperintense lesion count, EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed observation duration as the offset variable.||1.502|0.905|0.2362
74058076|NCT04410991|147667845|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|2.118|||<|0.0001|TWO_SIDED|95.0|1.502|2.987|||Chi-squared|||Analysis was performed using negative binomial model with the number of new Gd-enhancing T1-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed number of MRI scans as the offset variable.||2.987|1.502|<0.0001
74058077|NCT04410991|147667846|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Least square (LS) mean difference|-0.053||||0.31|TWO_SIDED|95.0|-0.156|0.05|||MMRM|||Covariates in the mixed-effect model with repeated measures (MMRM) were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||0.050|-0.156|0.3100
74058078|NCT04410991|147667847|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|-0.612||||0.5235|TWO_SIDED|95.0|-2.493|1.269|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||1.269|-2.493|0.5235
74058079|NCT04410991|147667848|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|1.652||||0.0079|TWO_SIDED|95.0|1.145|2.383||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||2.383|1.145|0.0079
74058080|NCT04410991|147667849|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|0.044||||0.4266|TWO_SIDED|95.0|-0.065|0.153|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.153|-0.065|0.4266
74058081|NCT01195662|147667856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28|STANDARD_ERROR_OF_MEAN|1.1485||0.0002|TWO_SIDED|95.0|-6.54|-2.02||Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure used.|Longitudinal repeated measures|Data from all weeks during the double-blind treatment period were included.||Longitudinal repeated measures analysis using 'direct likelihood', with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, as well as continuous fixed covariates of baseline SBP value and baseline SBP value-by-week interaction. Unstructured matrix for within-subject error variance-covariance used. 80% power to detect a difference of 4 mmHg in mean change from baseline, 75% power to meet both co-primary endpoints with overall Type I error.||-2.02|-6.54|0.0002
74058082|NCT01195662|147667857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.0773|<|0.0001|TWO_SIDED|95.0|-0.76|-0.46|||Longitudinal repeated measures|Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure was used.||A longitudinal repeated measures analysis used, with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, continuous fixed covariates of baseline HbA1c value and baseline HbA1c value-by-week interaction. Only data up to Week 12 included. All data used in the model even if participants discontinued prior to Week 12. A heirarchical closed testing procedure (sequential) was used and testing performed since first primary endpoint was significant.||-0.46|-0.76|<0.0001
74058083|NCT01195662|147667858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.45|STANDARD_ERROR_OF_MEAN|1.368||0.0012|TWO_SIDED|95.0|-7.14|-1.76||Endpoint tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate was used. By applying sequential testing procedure, the testing was performed since the prior endpoint was significant.||-1.76|-7.14|0.0012
74058084|NCT01195662|147667859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.69||0.1619|TWO_SIDED|95.0|-2.32|0.39||Endpoint tested following a sequential testing procedure at alpha=0.05.|Longitudinal repeated measures|||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline seated diastolic BP value and baseline seated diastolic BP value by week interaction.||0.39|-2.32|0.1619
74058085|NCT01195662|147667860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|0.8635|||TWO_SIDED|95.0|-3.68|-0.29|||ANCOVA|||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate. A hierarchical closed testing procedure was implemented to control the family-wise type I error rate related to the co-primary and secondary endpoints at the 2-sided 0.05 level. Statistical testing of this endpoint was not performed since the prior secondary endpoint was not statistically significant.||-0.29|-3.68|
74058086|NCT01195662|147667861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.0858|||TWO_SIDED|95.0|-0.57|-0.23|||lLongitudinal repeated measures|||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline serum uric acid value and baseline seated serum uric acid value by week interaction. By applying sequential testing procedure at alpha=0.05, no testing was performed since the prior secondary endpoint was not significant.||-0.23|-0.57|
74058087|NCT01215968|147667867|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|2.19|||||TWO_SIDED|90.0|1.83|2.62|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 10 over Day 3.||||2.62|1.83|
74058088|NCT01215968|147667867|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.94|||||TWO_SIDED|90.0|1.61|2.33|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 17 over Day 3.||||2.33|1.61|
73881763|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2568|TWO_SIDED|95.0|-0.86|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.23|-0.86|0.2568
73881764|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2609|TWO_SIDED|95.0|-0.86|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.23|-0.86|0.2609
74058089|NCT01215968|147667867|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.91|||||TWO_SIDED|90.0|1.59|2.29|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 24 over Day 3.||||2.29|1.59|
74058090|NCT01215968|147667867|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.84|||||TWO_SIDED|90.0|1.52|2.22|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 31 over Day 3.||||2.22|1.52|
73881765|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4148|TWO_SIDED|95.0|-0.78|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.32|-0.78|0.4148
73881766|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5575|TWO_SIDED|95.0|-0.38|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.71|-0.38|0.5575
74058091|NCT05182840|147667891|OTHER||Mean Difference (Net)|-0.168||||0.0499|TWO_SIDED|95.0|-0.337|0.0|||MMRM||"Least Squares Mean of 3 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.000|-0.337|0.0499
74058092|NCT05182840|147667891|OTHER||Mean Difference (Net)|-0.486|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.313|||MMRM||"Least Squares Mean of 10 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.313|-0.660|<.0001
74058093|NCT05182840|147667891|OTHER||Mean Difference (Net)|-0.421|||<|0.0001|TWO_SIDED|95.0|-0.596|-0.246|||MMRM||"Least Squares Mean of 20 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.246|-0.596|<.0001
74058094|NCT05182840|147667891|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0||||||P-value was rounded to four decimal places.|MCPMod Emax model fit|Emax model fit assumption: 80% of the maximum effect is achieved at 10 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient."||||0.0000
74058095|NCT05182840|147667891|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0||||||P-value was rounded to four decimal places.|MCPMod linear model fit|Linear model fit assumption: No assumption is needed.||"A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient."||||0.0000
74058096|NCT05182840|147667891|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0.0003|||||||MCPMod exponential model fit|Exponential model fit assumption: 15% of the maximum effect is achieved at 10 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod). MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||||0.0003
74058097|NCT05182840|147667892|OTHER||Median Difference (Net)|-15.5|||||TWO_SIDED|95.0|-28.6|0.0|||||"Median of 3 mg BI 690517 - Median of Placebo to BI 690517."|||-0.0|-28.6|
74058098|NCT05182840|147667892|OTHER||Median Difference (Net)|-38.5|||||TWO_SIDED|95.0|-48.3|-26.8|||||"Median of 10 mg BI 690517 - Median of Placebo to BI 690517."|||-26.8|-48.3|
74058099|NCT05182840|147667892|OTHER||Median Difference (Net)|-34.3|||||TWO_SIDED|95.0|-44.9|-21.8|||||"Median of 20 mg BI 690517 - Median of Placebo to BI 690517."|||-21.8|-44.9|
74058100|NCT05182840|147667893|OTHER||Mean Difference (Net)|-0.227||||0.0867|TWO_SIDED|95.0|-0.488|0.033|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||0.033|-0.488|0.0867
74058101|NCT05182840|147667893|OTHER||Mean Difference (Net)|-0.469||||0.0007|TWO_SIDED|95.0|-0.737|-0.201|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.201|-0.737|0.0007
74058102|NCT05182840|147667893|OTHER||Mean Difference (Net)|-0.429||||0.0027|TWO_SIDED|95.0|-0.707|-0.151|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.151|-0.707|0.0027
74058103|NCT05182840|147667894|OTHER||Median Difference (Net)|-20.3|||||TWO_SIDED|95.0|-38.6|3.4|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|||3.4|-38.6|
74058104|NCT05182840|147667894|OTHER||Median Difference (Net)|-37.4|||||TWO_SIDED|95.0|-52.2|-18.2|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517"|||-18.2|-52.2|
74058105|NCT05182840|147667894|OTHER||Median Difference (Net)|-34.9|||||TWO_SIDED|95.0|-50.7|-14.0|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|||-14.0|-50.7|
73888201|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|45.5||||0.0187|TWO_SIDED|95.0|7.7|83.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.2|7.7|0.0187
74058106|NCT05182840|147667895|OTHER||Mean Difference (Net)|-0.098||||0.3737|TWO_SIDED|95.0|-0.316|0.119|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||0.119|-0.316|0.3737
74058107|NCT05182840|147667895|OTHER||Mean Difference (Net)|-0.502|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.275|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.275|-0.730|<.0001
74058108|NCT05182840|147667895|OTHER||Mean Difference (Net)|-0.404||||0.0004|TWO_SIDED|95.0|-0.625|-0.184|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.184|-0.625|0.0004
74058109|NCT05182840|147667896|OTHER||Median Difference (Net)|-9.4|||||TWO_SIDED|95.0|-27.1|12.7|||||"Median of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||12.7|-27.1|
74058110|NCT05182840|147667896|OTHER||Median Difference (Net)|-39.5|||||TWO_SIDED|95.0|-51.8|-24.0|||||"Median of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||-24.0|-51.8|
74058111|NCT05182840|147667896|OTHER||Median Difference (Net)|-33.2|||||TWO_SIDED|95.0|-46.5|-16.8|||||"Median of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||-16.8|-46.5|
74058112|NCT05182840|147667897|OTHER||Odds Ratio (OR)|2.08||||0.0136|TWO_SIDED|95.0|1.16|3.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.72|1.16|0.0136
74058113|NCT05182840|147667897|OTHER||Odds Ratio (OR)|7.02||||0|TWO_SIDED|95.0|3.94|12.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||12.49|3.94|0.0000
73881767|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1671|TWO_SIDED|95.0|-0.16|0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.92|-0.16|0.1671
73881768|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.9462|TWO_SIDED|95.0|-0.57|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.53|-0.57|0.9462
74058114|NCT05182840|147667897|OTHER||Odds Ratio (OR)|5.48||||0|TWO_SIDED|95.0|3.09|9.71||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.71|3.09|0.0000
74058115|NCT05182840|147667898|OTHER||Odds Ratio (OR)|2.15||||0.0111|TWO_SIDED|95.0|1.19|3.88||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.88|1.19|0.0111
74058116|NCT05182840|147667898|OTHER||Odds Ratio (OR)|6.33||||0|TWO_SIDED|95.0|3.49|11.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.49|3.49|0.0000
74058117|NCT05182840|147667898|OTHER||Odds Ratio (OR)|5.21||||0|TWO_SIDED|95.0|2.88|9.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.44|2.88|0.0000
74058118|NCT05182840|147667899|OTHER||Odds Ratio (OR)|1.8||||0.0348|TWO_SIDED|95.0|1.04|3.09||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.09|1.04|0.0348
74058119|NCT05182840|147667899|OTHER||Odds Ratio (OR)|4.12||||0|TWO_SIDED|95.0|2.4|7.08||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.08|2.40|0.0000
73881769|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0699|TWO_SIDED|95.0|-0.91|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.04|-0.91|0.0699
74058120|NCT05182840|147667899|OTHER||Odds Ratio (OR)|5.02||||0|TWO_SIDED|95.0|2.91|8.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.67|2.91|0.0000
74058121|NCT05182840|147667900|OTHER||Odds Ratio (OR)|2.15||||0.0111|TWO_SIDED|95.0|1.19|3.88||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.88|1.19|0.0111
74058122|NCT05182840|147667900|OTHER||Odds Ratio (OR)|6.33||||0|TWO_SIDED|95.0|3.49|11.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.49|3.49|0.0000
74058123|NCT05182840|147667900|OTHER||Odds Ratio (OR)|5.21||||0|TWO_SIDED|95.0|2.88|9.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.44|2.88|0.0000
74101220|NCT04856930|147751957|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|12.95||0.4951|TWO_SIDED|90.0|-30.35|12.62||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||12.62|-30.35|0.4951
74058124|NCT05182840|147667901|OTHER||Odds Ratio (OR)|2.44||||0.0419|TWO_SIDED|95.0|1.03|5.74||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.74|1.03|0.0419
74058125|NCT05182840|147667901|OTHER||Odds Ratio (OR)|6.09||||0|TWO_SIDED|95.0|2.64|14.08||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||14.08|2.64|0.0000
74058126|NCT05182840|147667901|OTHER||Odds Ratio (OR)|6.13||||0|TWO_SIDED|95.0|2.64|14.25||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||14.25|2.64|0.0000
74058127|NCT05182840|147667902|OTHER||Odds Ratio (OR)|2.88||||0.0195|TWO_SIDED|95.0|1.19|7.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.02|1.19|0.0195
74058128|NCT05182840|147667902|OTHER||Odds Ratio (OR)|6.38||||0|TWO_SIDED|95.0|2.65|15.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.35|2.65|0.0000
74058129|NCT05182840|147667902|OTHER||Odds Ratio (OR)|6.39||||0.0001|TWO_SIDED|95.0|2.6|15.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.67|2.60|0.0001
74058130|NCT05182840|147667903|OTHER||Odds Ratio (OR)|2.03||||0.0767|TWO_SIDED|95.0|0.93|4.42||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.42|0.93|0.0767
74058131|NCT05182840|147667903|OTHER||Odds Ratio (OR)|4.11||||0.0003|TWO_SIDED|95.0|1.89|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.89|0.0003
74058132|NCT05182840|147667903|OTHER||Odds Ratio (OR)|4.69||||0.0001|TWO_SIDED|95.0|2.15|10.24||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||10.24|2.15|0.0001
74058133|NCT05182840|147667904|OTHER||Odds Ratio (OR)|2.88||||0.0195|TWO_SIDED|95.0|1.19|7.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.02|1.19|0.0195
74058134|NCT05182840|147667904|OTHER||Odds Ratio (OR)|6.38||||0|TWO_SIDED|95.0|2.65|15.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.35|2.65|0.0000
74058135|NCT05182840|147667904|OTHER||Odds Ratio (OR)|6.39||||0.0001|TWO_SIDED|95.0|2.6|15.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.67|2.60|0.0001
74058136|NCT05182840|147667905|OTHER||Odds Ratio (OR)|1.82||||0.1398|TWO_SIDED|95.0|0.82|4.04||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.04|0.82|0.1398
74058137|NCT05182840|147667905|OTHER||Odds Ratio (OR)|8.42||||0|TWO_SIDED|95.0|3.73|19.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||19.02|3.73|0.0000
74058138|NCT05182840|147667905|OTHER|P-value was rounded to four decimal places.|Odds Ratio (OR)|4.98||||0.0001|TWO_SIDED|95.0|2.28|10.9|||Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||10.90|2.28|0.0001
74058139|NCT05182840|147667906|OTHER||Odds Ratio (OR)|1.71||||0.1884|TWO_SIDED|95.0|0.77|3.79||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.79|0.77|0.1884
74058140|NCT05182840|147667906|OTHER||Odds Ratio (OR)|6.8||||0|TWO_SIDED|95.0|2.94|15.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.72|2.94|0.0000
74058141|NCT05182840|147667906|OTHER||Odds Ratio (OR)|4.46||||0.0003|TWO_SIDED|95.0|2.0|9.94||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.94|2.00|0.0003
74058142|NCT05182840|147667907|OTHER||Odds Ratio (OR)|1.62||||0.214|TWO_SIDED|95.0|0.76|3.46||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.46|0.76|0.2140
74058143|NCT05182840|147667907|OTHER||Odds Ratio (OR)|4.13||||0.0003|TWO_SIDED|95.0|1.93|8.85||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.85|1.93|0.0003
74058144|NCT05182840|147667907|OTHER||Odds Ratio (OR)|5.43||||0|TWO_SIDED|95.0|2.52|11.71||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.71|2.52|0.0000
73881770|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0056|TWO_SIDED|95.0|-1.15|-0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.20|-1.15|0.0056
74058145|NCT05182840|147667908|OTHER||Odds Ratio (OR)|1.71||||0.1884|TWO_SIDED|95.0|0.77|3.79||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.79|0.77|0.1884
74101221|NCT03022084|147751999|NON_INFERIORITY|The probability that Desyncra is non-inferior to CBT, defined by the sponsor as the event that mean TQ score change from baseline in the Desyncra arm is no more than 3.5 points worse than the mean TQ change in the CBT arm.|||||||||||||Bayesian|Data collected to date were analyzed using a Bayesian approach.|||Data collected to date were analyzed using a Bayesian approach.|||
74101222|NCT00113763|147752013|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups||||<0.0001
74101223|NCT00113763|147752014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.806||||||This analysis was conducted contingent on a statistically significant difference in the primary outcome, and adjusted to an a priori threshold for statistical significance at a 4% level for a multiple comparison involving objective tumor response|Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups||||0.806
74101224|NCT03104400|147752041|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|34.5|||<|0.0001|TWO_SIDED|95.0|28.2|40.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||40.7|28.2|<0.0001
74101225|NCT03104400|147752041|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|42.3|||<|0.0001|TWO_SIDED|95.0|36.3|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||48.3|36.3|<0.0001
73881771|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1117|TWO_SIDED|95.0|-0.86|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.09|-0.86|0.1117
74058146|NCT05182840|147667908|OTHER||Odds Ratio (OR)|6.8||||0|TWO_SIDED|95.0|2.94|15.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.72|2.94|0.0000
74058147|NCT05182840|147667908|OTHER||Odds Ratio (OR)|4.46||||0.0003|TWO_SIDED|95.0|2.0|9.94||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.94|2.00|0.0003
74058148|NCT05182840|147667909|OTHER||Odds Ratio (OR)|2.18||||0.0024|TWO_SIDED|95.0|1.32|3.61||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.61|1.32|0.0024
74058149|NCT05182840|147667909|OTHER||Odds Ratio (OR)|4.05||||0|TWO_SIDED|95.0|2.39|6.86||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.86|2.39|0.0000
73881772|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0265|TWO_SIDED|95.0|-1.02|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.06|-1.02|0.0265
73881773|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1119|TWO_SIDED|95.0|-0.86|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.09|-0.86|0.1119
73881774|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.7607|TWO_SIDED|95.0|-0.54|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.40|-0.54|0.7607
73881775|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0437|TWO_SIDED|95.0|-0.97|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.01|-0.97|0.0437
73881776|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0211|TWO_SIDED|95.0|-1.51|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||-0.12|-1.51|0.0211
74058150|NCT05182840|147667909|OTHER||Odds Ratio (OR)|3.87||||0|TWO_SIDED|95.0|2.29|6.55||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.55|2.29|0.0000
74101226|NCT03104400|147752042|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Least Squares (LS) Mean Difference|-0.28|||<|0.0001|TWO_SIDED|95.0|-0.35|-0.22|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.22|-0.35|<0.0001
74101227|NCT03104400|147752042|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.34|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.27|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.27|-0.40|<0.0001
73881777|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.35||0.0017|TWO_SIDED|95.0|-1.82|-0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||-0.42|-1.82|0.0017
73881778|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0598|TWO_SIDED|95.0|-1.37|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.03|-1.37|0.0598
73881779|NCT03192176|147297636|SUPERIORITY||LSMean differencce|-0.5|STANDARD_ERROR_OF_MEAN|0.36||0.1573|TWO_SIDED|95.0|-1.21|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.20|-1.21|0.1573
73881780|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.7257|TWO_SIDED|95.0|-0.83|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.58|-0.83|0.7257
74058151|NCT05182840|147667910|OTHER||Odds Ratio (OR)|2.26||||0.0019|TWO_SIDED|95.0|1.35|3.77||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.77|1.35|0.0019
74058152|NCT05182840|147667910|OTHER||Odds Ratio (OR)|3.81||||0|TWO_SIDED|95.0|2.2|6.59||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.59|2.20|0.0000
74058153|NCT05182840|147667910|OTHER||Odds Ratio (OR)|3.67||||0|TWO_SIDED|95.0|2.12|6.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.35|2.12|0.0000
74058154|NCT05182840|147667911|OTHER||Odds Ratio (OR)|1.67||||0.0418|TWO_SIDED|95.0|1.02|2.74||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||2.74|1.02|0.0418
74058155|NCT05182840|147667911|OTHER||Odds Ratio (OR)|3.91||||0|TWO_SIDED|95.0|2.3|6.65||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.65|2.30|0.0000
74058156|NCT05182840|147667911|OTHER||Odds Ratio (OR)|3.58||||0|TWO_SIDED|95.0|2.11|6.05||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.05|2.11|0.0000
74058157|NCT05182840|147667912|OTHER||Odds Ratio (OR)|2.26||||0.0019|TWO_SIDED|95.0|1.35|3.77||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.77|1.35|0.0019
74058158|NCT05182840|147667912|OTHER||Odds Ratio (OR)|3.81||||0|TWO_SIDED|95.0|2.2|6.59||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.59|2.20|0.0000
74058159|NCT05182840|147667912|OTHER||Odds Ratio (OR)|3.67||||0|TWO_SIDED|95.0|2.12|6.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.35|2.12|0.0000
74058160|NCT05182840|147667913|OTHER||Odds Ratio (OR)|2.2||||0.0285|TWO_SIDED|95.0|1.09|4.45||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.45|1.09|0.0285
74058161|NCT05182840|147667913|OTHER||Odds Ratio (OR)|2.9||||0.0038|TWO_SIDED|95.0|1.41|5.96||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.96|1.41|0.0038
73881781|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9324|TWO_SIDED|95.0|-0.72|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.66|-0.72|0.9324
74058162|NCT05182840|147667913|OTHER||Odds Ratio (OR)|4.15||||0.0002|TWO_SIDED|95.0|1.97|8.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.72|1.97|0.0002
74058163|NCT05182840|147667914|OTHER||Odds Ratio (OR)|2.56||||0.0116|TWO_SIDED|95.0|1.23|5.31||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.31|1.23|0.0116
74058164|NCT05182840|147667914|OTHER||Odds Ratio (OR)|3.08||||0.0032|TWO_SIDED|95.0|1.46|6.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.52|1.46|0.0032
74058165|NCT05182840|147667914|OTHER||Odds Ratio (OR)|4.07||||0.0004|TWO_SIDED|95.0|1.86|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.86|0.0004
74058166|NCT05182840|147667915|OTHER||Odds Ratio (OR)|1.34||||0.4092|TWO_SIDED|95.0|0.67|2.69||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||2.69|0.67|0.4092
74058167|NCT05182840|147667915|OTHER||Odds Ratio (OR)|3.66||||0.0005|TWO_SIDED|95.0|1.77|7.58||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.58|1.77|0.0005
74058168|NCT05182840|147667915|OTHER||Odds Ratio (OR)|4.04||||0.0002|TWO_SIDED|95.0|1.92|8.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.49|1.92|0.0002
74058169|NCT05182840|147667916|OTHER||Odds Ratio (OR)|2.16||||0.0348|TWO_SIDED|95.0|1.06|4.43||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.43|1.06|0.0348
74058170|NCT05182840|147667916|OTHER||Odds Ratio (OR)|6.08||||0|TWO_SIDED|95.0|2.73|13.57||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||13.57|2.73|0.0000
73881782|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.2172|TWO_SIDED|95.0|-1.14|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.26|-1.14|0.2172
74058171|NCT05182840|147667916|OTHER||Odds Ratio (OR)|3.58||||0.0007|TWO_SIDED|95.0|1.71|7.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.52|1.71|0.0007
74058172|NCT05182840|147667917|OTHER||Odds Ratio (OR)|2.01||||0.0578|TWO_SIDED|95.0|0.98|4.14||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.14|0.98|0.0578
74058173|NCT05182840|147667917|OTHER||Odds Ratio (OR)|5.12||||0.0001|TWO_SIDED|95.0|2.23|11.78||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.78|2.23|0.0001
74058174|NCT05182840|147667917|OTHER||Odds Ratio (OR)|3.32||||0.0022|TWO_SIDED|95.0|1.54|7.16||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.16|1.54|0.0022
74058175|NCT05182840|147667918|OTHER||Odds Ratio (OR)|2.17||||0.0342|TWO_SIDED|95.0|1.06|4.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.44|1.06|0.0342
74058176|NCT05182840|147667918|OTHER||Odds Ratio (OR)|4.23||||0.0003|TWO_SIDED|95.0|1.93|9.24||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.24|1.93|0.0003
74058177|NCT05182840|147667918|OTHER||Odds Ratio (OR)|3.19||||0.0023|TWO_SIDED|95.0|1.52|6.73||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.73|1.52|0.0023
74058178|NCT05182840|147667919|OTHER||Odds Ratio (OR)|2.56||||0.0116|TWO_SIDED|95.0|1.23|5.31||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.31|1.23|0.0116
74058179|NCT05182840|147667919|OTHER||Odds Ratio (OR)|3.08||||0.0032|TWO_SIDED|95.0|1.46|6.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.52|1.46|0.0032
74058180|NCT05182840|147667919|OTHER||Odds Ratio (OR)|4.07||||0.0004|TWO_SIDED|95.0|1.86|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.86|0.0004
74058181|NCT05182840|147667920|OTHER||Odds Ratio (OR)|2.01||||0.0578|TWO_SIDED|95.0|0.98|4.14||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.14|0.98|0.0578
74058182|NCT05182840|147667920|OTHER||Odds Ratio (OR)|5.12||||0.0001|TWO_SIDED|95.0|2.23|11.78||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.78|2.23|0.0001
74058183|NCT05182840|147667920|OTHER||Odds Ratio (OR)|3.32||||0.0022|TWO_SIDED|95.0|1.54|7.16||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.16|1.54|0.0022
74058184|NCT00863265|147667923|EQUIVALENCE||Mean Difference (Final Values)|289.0||||0.01|TWO_SIDED||||||ANOVA||The estimation parameter is the difference between the placebo group and the ezetimibe group.|Phytosterol Diet compared to Ezetimibe||||0.01
74058185|NCT00863265|147667923|EQUIVALENCE|The hypothesis is that groups are equal.|Mean Difference (Final Values)|457.0|||<|0.01|TWO_SIDED||||||ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols||||<0.01
74058186|NCT00863265|147667923|EQUIVALENCE|The hypothesis is that groups are equal|Mean Difference (Final Values)|168.0|||<|0.01|TWO_SIDED||||||ANOVA|||Ezetimibe vs. Ezetimibe Plus Phytosterols||||<0.01
74058187|NCT00863265|147667924|EQUIVALENCE|Not applicable in this study.|Mean Difference (Final Values)|22.8|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal||||<0.01
74058188|NCT00863265|147667924|EQUIVALENCE||Mean Difference (Final Values)|36.4|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols||||<0.01
73881783|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.0742|TWO_SIDED|95.0|-0.88|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.04|-0.88|0.0742
74058189|NCT00863265|147667924|EQUIVALENCE||Mean Difference (Final Values)|13.6|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.||||<0.01
74058190|NCT00863265|147667925|EQUIVALENCE||Mean Difference (Final Values)|21.0|||<|0.01|TWO_SIDED||||||ANOVA|||The hypothesis is that groups are equal.||||<0.01
74058191|NCT00863265|147667925|EQUIVALENCE||Mean Difference (Final Values)|28.0|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that all groups are equal||||<0.01
74058192|NCT00863265|147667925|EQUIVALENCE||Mean Difference (Final Values)|7.0|||<|0.05|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.||||<0.05
74058193|NCT03677440|147667943|SUPERIORITY|||||||0.34|||||||ANOVA|||This involves a repeated-measures ANOVA testing a condition (i.e., treadmill walking exercise training vs. stretching-and-toning exercise training)-by-time (i.e., baseline, follow-up) interaction on Symbol Digit Modalities Test scores.||||.34
74058194|NCT03677440|147667944|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||||||.01
74058195|NCT03677440|147667945|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||.02
74058196|NCT03677440|147667946|SUPERIORITY|||||||0.63|||||||ANOVA|||||||.63
74058197|NCT03677440|147667947|SUPERIORITY||Partial eta-squared|0.067||||0.2|TWO_SIDED||||||ANOVA|||||||.20
73881784|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0035|TWO_SIDED|95.0|-1.16|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Score||-0.23|-1.16|0.0035
74058198|NCT03677440|147667948|SUPERIORITY|||||||0.96|||||||ANOVA|||||||.96
74058199|NCT03677440|147667949|SUPERIORITY|||||||0.55|||||||ANOVA|||||||.55
74058200|NCT03677440|147667950|SUPERIORITY||Partial eta-squared|0.087||||0.14|TWO_SIDED||||||ANOVA|||||||.14
74058201|NCT03677440|147667951|SUPERIORITY|||||||0.69|||||||ANOVA|||||||.69
74058202|NCT03677440|147667952|SUPERIORITY||Partial eta-squared|0.048||||0.28|TWO_SIDED||||||ANOVA|||||||.28
74058203|NCT00157820|147668009|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.31||||0.0028|TWO_SIDED|95.0|0.14|0.67|||Wilcoxon (Mann-Whitney)||An additional primary analysis was pre-planned: the odds ratio of CSAE-score between DC and SC obtained from SAS GENMOD procedure with the length of follow-up as an 'offset'.|"The assumed effect of the DC treatment was a reduction from 30 to 15% in the proportion of patients who develop a CSAE, as well as a 15% reduction in the mean of CSAE (from 6 to 5.1). The estimated sample size was 200 (DC true) vs. 100 (SC true) patients followed for 8 months, with a two-sided alfa \< 0.05 and a power of 88.8%.~The sample size was set up to 360 patients (120 patients per arm), considering losses in follow-up."||0.67|0.14|0.0028
74058204|NCT01441882|147668020|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.0106|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (lymph node size).||||0.0106
74058205|NCT01441882|147668020|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.1986|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (Absolute Lymphocyte Count (ALC)).||||0.19860
74058206|NCT01441882|147668020|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.5167|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (spleen size).||||0.5167
74058207|NCT00437294|147668042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||||||The 1-sided significance level was 0.20.|Log Rank|||||||0.237
74058208|NCT00437294|147668047|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||1-sided significance level was 0.20.|Fisher Exact|||||||1.00
74058209|NCT00437294|147668048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.812|||||||Log Rank|||||||0.812
74101228|NCT03104400|147752043|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|31.1|||<|0.0001|TWO_SIDED|95.0|24.7|37.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||37.5|24.7|<0.0001
74058210|NCT00437294|147668049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||Log Rank|||||||0.181
74058211|NCT02277665|147668057|SUPERIORITY|Chi-square|Odds Ratio (OR)|0.56|||=|0.33|TWO_SIDED|95.0|0.17|1.82|||Chi-squared|||||1.82|.17|= 0.33
74058212|NCT02277665|147668058|OTHER||Odds Ratio (OR)|0.32||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
73881785|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0266|TWO_SIDED|95.0|-0.99|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||-0.06|-0.99|0.0266
74058213|NCT02277665|147668059|OTHER||Odds Ratio (OR)|0.45|||=|0.16|TWO_SIDED|95.0|0.15|1.35|||Chi-squared|||||1.35|0.15|= 0.16
74058214|NCT02277665|147668060|SUPERIORITY||Means Ratio|0.97||||0.87|TWO_SIDED|95.0|0.66|1.42|||Chi-squared|||||1.42|0.66|0.87
74058215|NCT02277665|147668061|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
74058216|NCT02277665|147668062|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
74058217|NCT02544607|147668089|OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
74058218|NCT02544607|147668090|OTHER|||||||0.048|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.048
74058219|NCT02544607|147668091|OTHER|||||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.003
74058220|NCT02544607|147668092|OTHER|||||||0.0499|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.0499
74058221|NCT02544607|147668093|OTHER|||||||0.038|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.038
74058222|NCT03309072|147668142|OTHER|To compare the old and new faces' hit rate, we calculated the true positive rate (TPR: the proportion of positives that are correctly identified as such). A repeated measures ANOVA was conducted with the TPR for both old and new faces as within-subjects variable and group (active vs sham) as between-subjects variable.|Mean Difference (Net)|10.66|||<|0.049|TWO_SIDED||||||ANOVA||Difference between active tDCS and sham tDCS|||||<.049
74058223|NCT01256086|147668210|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Relative potency of Novolizer compared to Aerolizer. Equivalence was to be concluded if the CI for the relative potency was completely covered by the interval (0.67, 1.50) according to OIP Guideline.|Relative potency|1.13|||||TWO_SIDED|90.0|0.94|1.38|||||Fieller confidence interval for logarithm of relative potency|||1.38|0.94|
73881786|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0124|TWO_SIDED|95.0|-1.06|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||-0.13|-1.06|0.0124
74058224|NCT05604521|147668213|SUPERIORITY|||||||0.3944|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any local solicited AEs after any vaccination.||||0.3944
74058225|NCT05604521|147668213|SUPERIORITY|||||||0.3717|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any systemic solicited AEs after any vaccination.||||0.3717
74058226|NCT05604521|147668213|SUPERIORITY|||||||1|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any related unsolicited AEs after any vaccination.||||1.0
74058227|NCT03681769|147668214|EQUIVALENCE|Non-equivalence determined by p\<.05.||||||0.83||||||No site X time interaction (F12,270 = 0.614, p = 0.830).|Mixed Models Analysis|||||||.83
74058228|NCT03681769|147668215|OTHER|||||||0.53|||||||t-test, 2 sided|||||||.53
74058229|NCT01491737|147668233|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.007|TWO_SIDED|95.0|0.48|0.89||Test was performed at 2-sided alpha of 5%.|Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Primary Analysis. Log Rank tested the following: Null Hypothesis (H0): the distribution of the PFS time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the PFS time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to PFS was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||0.89|0.48|0.0070
74058230|NCT01491737|147668233|OTHER|Exploratory|Hazard Ratio (HR)|0.67||||0.0059|TWO_SIDED|95.0|0.5|0.89|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Final Analysis||0.89|0.50|0.0059
74058231|NCT01491737|147668234|OTHER|Exploratory|Hazard Ratio (HR)|1.15||||0.585|TWO_SIDED|95.0|0.69|1.91|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Primary Analysis. This study was not powered for overall survival (OS), so adequately powered statistical testing for this outcome measure was not possible.||1.91|0.69|0.5850
74058232|NCT01491737|147668234|OTHER|Exploratory|Hazard Ratio (HR)|1.05||||0.7833|TWO_SIDED|95.0|0.73|1.52|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Final Analysis. This study was not powered for overall survival (OS), so adequately powered statistical testing for this outcome measure was not possible.||1.52|0.73|0.7833
74058233|NCT01491737|147668235|SUPERIORITY||Difference in ORR|7.6||||0.2537|TWO_SIDED|95.0|-6.0|21.3||Test was performed at 2-sided alpha of 5%. There was no multiplicity adjustment.|Chi-squared|||ORR for Arm A vs Arm B||21.3|-6.0|0.2537
74058234|NCT01491737|147668236|SUPERIORITY||Difference in CBR|1.8||||0.7743|TWO_SIDED|95.0|-11.2|14.8||Test was performed at 2-sided alpha of 5%. There was no multiplicity adjustment.|Chi-squared|||CBR for Arm A vs. Arm B||14.8|-11.2|0.7743
74058235|NCT01491737|147668237|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0181|TWO_SIDED|95.0|0.36|0.91||Test was performed at 2-sided alpha of 5%.|Log Rank|Log-rank test from unstratified analysis based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including stratification factors of induction chemotherapy and prior adjuvant hormone therapy.|Primary Analysis. Log Rank tested the following: Null Hypothesis (H0): the distribution of the DOR time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the DOR time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to DOR was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||0.91|0.36|0.0181
74058236|NCT01491737|147668237|OTHER|Exploratory|Hazard Ratio (HR)|0.62||||0.0205|TWO_SIDED|95.0|0.41|0.93|||Log Rank|Log-rank test from unstratified analysis based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including stratification factors of induction chemotherapy and prior adjuvant hormone therapy.|Final Analysis.||0.93|0.41|0.0205
74058237|NCT01491737|147668238|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5597|TWO_SIDED|95.0|0.78|1.57||Test was performed at 2-sided alpha of 5%.|Log Rank|The log-rank test from unstratified analysis was based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including the induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Log Rank tested the following: Null Hypothesis (H0): the distribution of the TTR time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the TTR time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to TTR was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||1.57|0.78|0.5597
73881787|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.4367|TWO_SIDED|95.0|-0.65|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.28|-0.65|0.4367
74058238|NCT01817764|147668247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074|||<|0.001|TWO_SIDED|95.0|0.038|0.11|||ANCOVA|||||0.110|0.038|<0.001
74058239|NCT02255422|147668249|SUPERIORITY||LS mean difference (net)|-0.015|STANDARD_ERROR_OF_MEAN|0.0446||0.7321|TWO_SIDED|95.0|-0.1051|0.0743||P-Value relates to difference in change in peak work from baseline relative to placebo for all doses pooled. Statistical significance was defined as p\<0.05|Mixed Models Analysis|Null hypothesis: wk 12 mean change from baseline (\[μ RTA 408\] - \[μ Placebo\]) in peak work = 0 w/kg. Positive change from baseline suggests improvement||Primary Objective: To evaluate the change in peak work during maximal exercise testing||0.0743|-0.1051|0.7321
74058240|NCT02255422|147668250|SUPERIORITY||LS mean difference (net)|-33.448|STANDARD_ERROR_OF_MEAN|11.6473||0.006|TWO_SIDED|95.0|-56.855|-10.042||P-value comparison is for difference in change in six minute walk distance from baseline within each dosage group relative to placebo. Statistical significance defined as p\<0.05.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 4||-10.042|-56.855|0.0060
74058241|NCT02255422|147668250|SUPERIORITY||LS mean difference (net)|-3.963|STANDARD_ERROR_OF_MEAN|11.53||0.7325|TWO_SIDED|95.0|-27.133|19.207||Statistical significance was defined as p\<0.05. The p-value comparison is for the difference in change in 6MWD from baseline within each dosage group relative to placebo.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 8||19.207|-27.133|0.7325
74058242|NCT02255422|147668250|SUPERIORITY||LS mean difference (net)|-18.594|STANDARD_ERROR_OF_MEAN|15.0004||0.221|TWO_SIDED|95.0|-48.739|11.55||Statistical significance was defined as p\<0.05. The p-value comparison is for the difference in change in 6MWD from baseline within each dosage group relative to placebo.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 12||11.550|-48.739|0.2210
74058243|NCT03222570|147668261|SUPERIORITY||Estimated mean difference|-0.88||||0.76|TWO_SIDED|95.0|-6.56|4.7|||Regression, Linear||Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure.|||4.7|-6.56|0.76
74058244|NCT03222570|147668262|SUPERIORITY||Estimated mean difference|-2.52||||0.32|TWO_SIDED|95.0|-7.42|2.3|||Regression, Linear||Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure.|||2.3|-7.42|0.32
73881788|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.9318|TWO_SIDED|95.0|-0.48|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.44|-0.48|0.9318
74101229|NCT03104400|147752043|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|43.1|||<|0.0001|TWO_SIDED|95.0|36.7|49.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.6|36.7|<0.0001
73881789|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0714|TWO_SIDED|95.0|-0.89|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.04|-0.89|0.0714
73881790|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42||0.2027|TWO_SIDED|95.0|-1.35|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||0.29|-1.35|0.2027
74101230|NCT03104400|147752044|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|41.3|||<|0.0001|TWO_SIDED|95.0|32.8|49.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.8|32.8|<0.0001
74101231|NCT03104400|147752044|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|41.1|||<|0.0001|TWO_SIDED|95.0|32.5|49.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.6|32.5|<0.0001
74101232|NCT03104400|147752045|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.29||||0.0002|TWO_SIDED|95.0|-0.44|-0.14|||ANCOVA|ANCOVA model including treatment and the stratification factor current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.14|-0.44|0.0002
74101233|NCT03104400|147752045|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.21||||0.0069|TWO_SIDED|95.0|-0.36|-0.06|||ANCOVA|ANCOVA model including treatment and the stratification factor current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.06|-0.36|0.0069
74101234|NCT03104400|147752046|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|24.3|||<|0.0001|TWO_SIDED|95.0|18.8|29.8||Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Cochran-Mantel-Haenszel||Response Rate Difference = Upadacitinib - Placebo|||29.8|18.8|<0.0001
74101235|NCT03104400|147752046|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|33.1|||<|0.0001|TWO_SIDED|95.0|27.4|38.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||38.8|27.4|<0.0001
74101236|NCT03104400|147752047|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|21.3|||<|0.0001|TWO_SIDED|95.0|13.0|29.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.7|13.0|<0.0001
74101237|NCT03104400|147752047|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|25.3|||<|0.0001|TWO_SIDED|95.0|16.9|33.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||33.7|16.9|<0.0001
73881791|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.41||0.0013|TWO_SIDED|95.0|-2.16|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.53|-2.16|0.0013
73881792|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.53|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.87|-2.53|<0.0001
73888202|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|76.9||||0.0009|TWO_SIDED|95.0|31.9|121.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||121.9|31.9|0.0009
74058245|NCT05643573|147668280|SUPERIORITY||Cox Proportional Hazard|3.785|||<|0.0001|TWO_SIDED|95.0|2.457|5.833|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||5.833|2.457|<.0001
74058246|NCT05643573|147668280|SUPERIORITY||Fine-Gray model|3.79|||<|0.0001|TWO_SIDED|95.0|2.46|5.839|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||5.839|2.460|<.0001
74058247|NCT05643573|147668281|SUPERIORITY||Fine-Gray model|0.319|||<|0.0001|TWO_SIDED|95.0|0.185|0.552|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||0.552|0.185|<.0001
74058248|NCT05643573|147668281|SUPERIORITY||Fine-Gray model|0.316|||<|0.0001|TWO_SIDED|95.0|0.182|0.547|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||0.547|0.182|<.0001
74058249|NCT05643573|147668282|SUPERIORITY||Fine-Gray model|1.61||||0.0011|TWO_SIDED|95.0|1.207|2.149|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||2.149|1.207|0.0011
74058250|NCT05643573|147668282|SUPERIORITY||Fine-Gray model|1.599||||0.0013|TWO_SIDED|95.0|1.197|2.134|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||2.134|1.197|0.0013
74058251|NCT02268214|147668296|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.0697|<|0.0001|TWO_SIDED|95.0|-0.56|-0.28|||RMM|Repeated Measures Model||||-0.28|-0.56|<0.0001
74058252|NCT02268214|147668296|SUPERIORITY||Median Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.0696|<|0.0001|TWO_SIDED|95.0|-0.58|-0.31|||RMM|Repeated Measures Model||||-0.31|-0.58|<0.0001
74058253|NCT02268214|147668297|SUPERIORITY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.9555|<|0.0001|TWO_SIDED|95.0|-12.56|-4.88|||RMM|Repeated Measures Model||||-4.88|-12.56|<0.0001
74058254|NCT02268214|147668297|SUPERIORITY||Mean Difference (Final Values)|-13.17|STANDARD_ERROR_OF_MEAN|1.8643|<|0.0001|TWO_SIDED|95.0|-16.75|-9.43|||RMM|Repeated Measures Model||||-9.43|-16.75|<0.0001
74058255|NCT02268214|147668298|SUPERIORITY||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|0.3251|<|0.0001|TWO_SIDED|95.0|-3.68|-2.41|||RMM|Repeated Measures Model||||-2.41|-3.68|<0.0001
74058256|NCT02268214|147668298|SUPERIORITY||Mean Difference (Final Values)|-3.72|STANDARD_ERROR_OF_MEAN|0.3213|<|0.0001|TWO_SIDED|95.0|-4.34|-3.08|||RMM|Repeated Measures Model||||-3.08|-4.34|<0.0001
74058257|NCT02268214|147668299|SUPERIORITY||Mean Difference (Final Values)|-15.34|STANDARD_ERROR_OF_MEAN|2.4859|<|0.0001|TWO_SIDED|95.0|-20.22|-10.46|||RMM|Repeated Measures Model||||-10.46|-20.22|<0.0001
74058258|NCT02268214|147668299|SUPERIORITY||Mean Difference (Final Values)|-18.03|STANDARD_ERROR_OF_MEAN|2.505|<|0.0001|TWO_SIDED|95.0|-22.95|-13.11|||RMM|Repeated Measures Model||||-13.11|-22.95|<0.0001
74058259|NCT02268214|147668300|SUPERIORITY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|2.6273|<|0.0001|TWO_SIDED|95.0|-22.46|-12.14|||RMM|Repeated Measures Model||||-12.14|-22.46|<0.0001
74058260|NCT02268214|147668300|SUPERIORITY||Mean Difference (Final Values)|-18.93|STANDARD_ERROR_OF_MEAN|2.6482|<|0.0001|TWO_SIDED|95.0|-24.13|-13.73|||RMM|Repeated Measures Model||||-13.73|-24.13|<0.0001
74058261|NCT02268214|147668301|SUPERIORITY||Mean Difference (Final Values)|9.11|STANDARD_ERROR_OF_MEAN|1.1611|<|0.0001|TWO_SIDED|95.0|6.83|11.39|||RMM|Repeated Measures Model||||11.39|6.83|<0.0001
74058262|NCT02268214|147668301|SUPERIORITY||Mean Difference (Final Values)|10.65|STANDARD_ERROR_OF_MEAN|1.1689|<|0.0001|TWO_SIDED|95.0|8.35|12.94|||RMM|Repeated Measures Model||||12.94|8.35|<0.0001
74058263|NCT02268214|147668302|SUPERIORITY||Odds Ratio (OR)|3.09|STANDARD_ERROR_OF_MEAN|0.198|<|0.0001|TWO_SIDED|95.0|2.1|4.56|||Regression, Logistic|||||4.56|2.10|<0.0001
74058264|NCT02268214|147668302|SUPERIORITY||Odds Ratio (OR)|3.29|STANDARD_ERROR_OF_MEAN|0.1979|<|0.0001|TWO_SIDED|95.0|2.23|4.85|||Regression, Logistic|||||4.85|2.23|<0.0001
74058265|NCT04342390|147668303|SUPERIORITY|||||||0.363|||||||ANCOVA|||||||0.363
74058266|NCT04342390|147668304|SUPERIORITY|||||||0.633|||||||ANCOVA|||||||0.633
74058267|NCT04342390|147668305|SUPERIORITY|||||||0.433|||||||ANCOVA|||||||0.433
74058268|NCT04342390|147668306|SUPERIORITY|||||||0.822|||||||ANCOVA|||||||0.822
74058269|NCT04342390|147668307|SUPERIORITY|||||||0.554|||||||ANCOVA|||||||0.554
74058270|NCT04342390|147668308|SUPERIORITY|||||||0.186|||||||ANCOVA|||||||0.186
74058271|NCT04342390|147668309|SUPERIORITY|||||||0.921|||||||ANCOVA|||||||0.921
74058272|NCT00318357|147668337|SUPERIORITY|||||||0.007|||||||Regression, Cox|||Mortality is compared between the arms of the CARE-HF study, using Cox proportional hazards regression. Data from the original CARE-HF trial and the CARE-HF Long Term Follow-up trial were combined for the analysis.||||0.007
74058273|NCT04089566|147668338|SUPERIORITY|The Analysis of Covariance (ANCOVA) model used rank score as response, treatment as fixed effect and disease duration at screening, baseline Hammersmith Infant Neurological Examination (HINE) Section 2 (HINE 2), baseline CHOP INTEND total score as covariates.|Least square (LS) mean difference|26.06|STANDARD_ERROR_OF_MEAN|4.141|<|0.0001|TWO_SIDED|95.0|17.941|34.172|||ANCOVA|||||34.172|17.941|< 0.0001
74058274|NCT04089566|147668361|SUPERIORITY||Difference of percentages|58.0|||<|0.0001|TWO_SIDED|95.0|39.46|71.81|||Fisher Exact||Exact unconditional confidence interval|||71.81|39.46|<0.0001
73888203|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|45.4||||0.0456|TWO_SIDED|95.0|0.9|89.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||89.9|0.9|0.0456
74058275|NCT04089566|147668362|SUPERIORITY||LS mean difference|26.67|STANDARD_ERROR_OF_MEAN|4.009|<|0.0001|TWO_SIDED|95.0|18.812|34.526||ANCOVA model was used treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||34.526|18.812|<0.0001
74058276|NCT04089566|147668363|SUPERIORITY||LS geometric mean ratio|0.08|||<|0.0001||||||ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.|ANCOVA|||||||<0.0001
74058277|NCT04089566|147668364|SUPERIORITY||LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|5.251|=|0.8484|TWO_SIDED|95.0|-9.29|11.299||ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||11.299|-9.29|=0.8484
74058278|NCT04089566|147668365|SUPERIORITY||LS mean difference|6.12|STANDARD_ERROR_OF_MEAN|4.497|=|0.1734|TWO_SIDED|95.0|-2.693|14.939||ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||14.939|-2.693|=0.1734
74058279|NCT04089566|147668366|SUPERIORITY||LS geometric mean ratio|0.51|||=|0.002|TWO_SIDED|95.0|0.33|0.78||ANCOVA model was used with treatment as a fixed effect and adjustment for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.|ANCOVA|||||0.78|0.33|=0.002
74058280|NCT04089566|147668409|SUPERIORITY||LS geometric mean ratio|0.86|||=|0.3785|TWO_SIDED|95.0|0.62|1.2||ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log CSF NF-L and baseline CHOP INTEND total score.|ANCOVA|||||1.2|0.62|=0.3785
74058281|NCT00056472|147668428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||<|0.001||95.0|1.12|1.47|||Regression, Logistic|||Predicting remission rates of 40% in combination therapy and 20% in monotherapy subjects, 260 subjects randomized into the two treatment groups would provide \>80% power at a two-tailed alpha level of .05. Treatment efficacy was compared between groups based on intent-to-treat analyses for the longitudinal binary outcome of remission using mixed effects logistic regression with a random intercept that included treatment and time as fixed effects and a treatment by time interaction effect.||1.47|1.12|<.001
74058282|NCT00056472|147668429|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||The p-value is for the overall mean CGI-S score compared to baseline.|Mixed Models Analysis|This was a longitudinal analysis of CGI-S scores compared to baseline.||Intent-to-treat changes in global improvement from week to week compared to baseline (CGI-S) over the course of the trial using longitudinal mixed effects linear regression models. The null hypothesis is that there is no difference in overall change in CGI-S.||||.02
74058283|NCT00056472|147668430|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the overall mean across all time points between each treatment group.|Mixed Models Analysis|||Intent-to-treat between group comparison using longitudinal mixed effects regression.||||<.001
74058284|NCT03378921|147668433|SUPERIORITY|||||||0.183||||||The threshold for statistical significance was P = 0.05|Log Rank|||The sample size (n = 26) was calculated according to the estimation that the remission rate in the FMT group would be 80% and 25% in the placebo group during the follow-up of 1 year. This difference of 55% was considered to be clinically meaningful. The significance level was selected to be 1%, and the power was set to 90%.||||0.183
74058285|NCT01054443|147668482|OTHER||Cochran-Armitage Trend Test Statistic|0.173||||0.431|||||||Cochran-Armitage Trend Test|||The primary efficacy evaluation was to test if there was a linear relationship existing such that the higher the dose level, the larger the percentage of responders. The Cochran-Armitage trend test was employed by assigning the score 0, 0.5, 0.75, and 1 to placebo, lusutrombopag 0.5, 0.75, and 1.0 mg group, respectively, at the 0.025 level of significance (1-sided) to determine the test statistic for detecting a dose-response in the percentage of responders.||||0.431
74058286|NCT01054443|147668483|OTHER||LS Mean Difference|25544.0|||||TWO_SIDED|95.0|6202.8|44885.3|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||44885.3|6202.8|
74058287|NCT01054443|147668483|OTHER||LS Mean Difference|11801.3|||||TWO_SIDED|95.0|-8809.3|32411.9|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||32411.9|-8809.3|
74058288|NCT01054443|147668483|OTHER||LS Mean Difference|756.6|||||TWO_SIDED|95.0|-18794.3|20307.5|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||20307.5|-18794.3|
74058289|NCT01875731|147668503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.09||||0.01|TWO_SIDED|95.0|1.57|16.8|||Chi-squared|||||16.8|1.57|0.01
74058290|NCT01875731|147668504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.71|TWO_SIDED|95.0|0.1|4.09|||Chi-squared|||||4.09|0.1|0.71
74058291|NCT00124709|147668569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0046||||0.7901|TWO_SIDED|95.0|-0.029|0.0381|||ANCOVA|Treatment, Center, gender, baseline age (months), baseline EASI score, and baseline TBSA as explanatory variables||"A disease-free day in Step 2 or less was defined as a diary day with variable No or almost no eczema?=yes and medication used variable=no except emollients, yellow label medication 2X day, or medication deviation of yellow label medication 1x day."||0.0381|-0.0290|0.7901
74058292|NCT01728376|147668583|SUPERIORITY_OR_OTHER||Difference (%)|-2.5|||||TWO_SIDED|95.0|-30.3|25.3|||||Daptomycin minus Comparator 95% Confidence Interval (CI) by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||25.3|-30.3|
74058293|NCT01728376|147668583|SUPERIORITY_OR_OTHER||Difference (%)|16.3|||||TWO_SIDED|95.0|-13.0|45.7|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||45.7|-13.0|
74058294|NCT01728376|147668583|SUPERIORITY_OR_OTHER||Difference (%)|25.7|||||TWO_SIDED|95.0|-21.0|72.4|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||72.4|-21.0|
73881793|NCT03192176|147297636|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.83|-1.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-1.16|-2.83|<0.0001
73881794|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.42||0.3791|TWO_SIDED|95.0|-1.19|0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||0.45|-1.19|0.3791
74101238|NCT03104400|147752048|NON_INFERIORITY|"Non-inferiority of each upadacitinib dose versus adalimumab was assessed using Koch's 3-arm approach; non-inferiority was achieved if upadacitinib preserved at least 50% of the placebo-subtracted adalimumab effect.~The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path."|Percent Adalimumab Effect Preservation|119.381|||<|0.0001|TWO_SIDED|95.0|97.987|147.942|||Koch 3-Arm Test||The percent of adalimumab effect preservation is the point estimate of 3-arm non-inferiority analysis, which is calculated by (Upadacitinib - Placebo) / (Adalimumab - Placebo) \* 100.|||147.942|97.987|<0.0001
74101239|NCT03104400|147752048|NON_INFERIORITY|"Non-inferiority of each upadacitinib dose versus adalimumab was assessed using Koch's 3-arm approach; non-inferiority was achieved if upadacitinib preserved at least 50% of the placebo-subtracted adalimumab effect.~The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path."|Percent Adalimumab Effect Preservation|146.604|||<|0.0001|TWO_SIDED|95.0|122.817|180.398|||Koch 3-Arm Test||The percent of adalimumab effect preservation is the point estimate of 3-arm non-inferiority analysis, which is calculated by (Upadacitinib - Placebo) / (Adalimumab - Placebo) \* 100.|||180.398|122.817|<0.0001
74101240|NCT03104400|147752049|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|4.67|||<|0.0001|TWO_SIDED|95.0|3.67|5.67|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.67|3.67|<0.0001
74101241|NCT03104400|147752049|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|5.72|||<|0.0001|TWO_SIDED|95.0|4.71|6.72|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.72|4.71|<0.0001
74101242|NCT03104400|147752050|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.4|4.7|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||4.7|2.4|<0.0001
74101243|NCT03104400|147752050|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|4.3|||<|0.0001|TWO_SIDED|95.0|3.1|5.5|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.5|3.1|<0.0001
74101244|NCT03104400|147752051|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|5.6||||0.0815|TWO_SIDED|95.0|-0.6|11.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Adalimumab|||11.8|-0.6|0.0815
73881795|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42||0.0211|TWO_SIDED|95.0|-1.78|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.15|-1.78|0.0211
73881796|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.42||0.0021|TWO_SIDED|95.0|-2.1|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.47|-2.10|0.0021
74101245|NCT03104400|147752051|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|13.5|||<|0.0001|TWO_SIDED|95.0|7.5|19.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Adalimumab|||19.4|7.5|<0.0001
74101246|NCT03104400|147752052|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|36.8|||<|0.0001|TWO_SIDED|95.0|25.7|47.9||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||47.9|25.7|<0.0001
73881797|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.889|TWO_SIDED|95.0|-0.55|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 8: Psychological Mean Score||0.48|-0.55|0.8890
74058295|NCT01728376|147668584|SUPERIORITY_OR_OTHER||Difference (%)|5.0|||||TWO_SIDED|95.0|-29.8|39.8|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||39.8|-29.8|
74058296|NCT01728376|147668584|SUPERIORITY_OR_OTHER||Difference (%)|37.9|||||TWO_SIDED|95.0|0.7|75.1|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||75.1|0.7|
74058297|NCT01728376|147668584|SUPERIORITY_OR_OTHER||Difference (%)|-10.0||||||95.0|-60.3|40.3|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||40.3|-60.3|
74058298|NCT00526162|147668591|OTHER||percentage|0.0|||<|0.03|ONE_SIDED|97.0||||Using a confidence interval of 97%, the exact binomial upper confidence bound was 9.5% which is lower than the 10% set for the primary safety objective. Therefore, the actual p-value has not been calculated further.|One proportion binomial exact||The confidence interval was calculated based on 35 patients who completed 1-month follow-up at interim analysis.|||||<0.03
74058299|NCT01797458|147668641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||Twenty-five teeth experienced at least one 'Minor' failure (reversible pulpitis, caries progression, and secondary caries): NRCT 9 (6.4%), CR 14 (10%), HT 2 (1.4%).|Kruskal-Wallis|||The null hypothesis was no difference at 2 yrs among any of the 3 arms for the primary outcome of success or minor failure.||||0.02
74058300|NCT03557775|147668653|SUPERIORITY|||||||0.041||||||Result for time by group interaction (threshold for statistical significance set at 0.05).|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.041
74058301|NCT03557775|147668654|SUPERIORITY|||||||0.887||||||Result for time by group interaction. Statistical threshold set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.887
74058302|NCT03557775|147668655|SUPERIORITY|||||||0.733||||||Result for time by group interaction effect. Threshold for statistical significance was set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.733
74058303|NCT03557775|147668656|SUPERIORITY|||||||0.702||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.702
74058304|NCT03557775|147668657|SUPERIORITY|||||||0.198||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.198
74058305|NCT03557775|147668658|SUPERIORITY|||||||0.388||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.388
74058306|NCT03557775|147668659|SUPERIORITY|||||||0.296||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.296
74058307|NCT03557775|147668660|SUPERIORITY|||||||0.04||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.040
74058308|NCT03557775|147668661|SUPERIORITY|||||||0.887||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.887
74058309|NCT03557775|147668662|SUPERIORITY|||||||0.663||||||Result for time by group interaction effect. Threshold for statistical significance was set 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.663
74058310|NCT03557775|147668663|SUPERIORITY|||||||0.026||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.026
74058311|NCT03557775|147668664|SUPERIORITY|||||||0.721||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.721
74058312|NCT03557775|147668665|SUPERIORITY|||||||0.408||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.408
74058313|NCT03557775|147668666|SUPERIORITY|||||||0.638||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.638
74058314|NCT03557775|147668667|SUPERIORITY|||||||0.715||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.715
73881798|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5568|TWO_SIDED|95.0|-0.67|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.36|-0.67|0.5568
74058315|NCT03557775|147668668|SUPERIORITY|||||||0.708||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.708
74058316|NCT03557775|147668669|SUPERIORITY|||||||0.988||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.988
74058317|NCT04410978|147668757|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.061||||0.6691|TWO_SIDED|95.0|0.808|1.393||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Analysis was performed using negative binomial model with number of adjudicated relapses onset between randomization date and EOS date as the response variable, treatment group, Gadolinium (Gd)-enhancing T1 lesions at baseline (presence, absence), expanded disability status scale (EDSS) strata (\<4, \>=4) and geographic region (United States \[US\], non-US) as covariates, and log transformed observation duration as the offset variable.||1.393|0.808|0.6691
74058318|NCT04410978|147668758|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.85||||0.4888|TWO_SIDED|95.0|0.565|1.278||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.278|0.565|0.4888
74058319|NCT04410978|147668759|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.819||||0.2991|TWO_SIDED|95.0|0.582|1.151||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.151|0.582|0.2991
74058320|NCT04410978|147668760|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.084||||0.4575|TWO_SIDED|95.0|0.876|1.342|||Chi-squared|||Analysis was performed using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, baseline T2-hyperintense lesion count, EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed observation duration as the offset variable.||1.342|0.876|0.4575
74058321|NCT04410978|147668761|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.86||||0.0001|TWO_SIDED|95.0|1.358|2.548|||Chi-squared|||Analysis was performed using negative binomial model with the number of new Gd-enhancing T1-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed number of MRI scans as the offset variable.||2.548|1.358|0.0001
74058322|NCT04410978|147668762|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Least square (LS) mean difference|0.035||||0.432|TWO_SIDED|95.0|-0.053|0.124|||MMRM|||Covariates in the mixed-effect model with repeated measures (MMRM) were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||0.124|-0.053|0.4320
74058323|NCT04410978|147668763|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|1.873||||0.0675|TWO_SIDED|95.0|-0.135|3.88|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||3.880|-0.135|0.0675
74058324|NCT04410978|147668764|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.831||||0.3594|TWO_SIDED|95.0|0.554|1.245||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.245|0.554|0.3594
74058325|NCT04410978|147668765|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|0.196||||0.0002|TWO_SIDED|95.0|0.093|0.298|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.298|0.093|0.0002
74058326|NCT05153629|147668775|OTHER|||||||0.93||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of back pain.||||0.93
74058327|NCT05153629|147668775|OTHER|||||||0.76||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of abdominal/groin pain.||||0.76
74058328|NCT05153629|147668775|OTHER|||||||0.56||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of pain frequency.||||0.56
74058329|NCT05153629|147668775|OTHER|||||||0.26||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of nausea intensity.||||0.26
74058330|NCT05153629|147668776|OTHER|||||||0.55||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in back pain.||||0.55
74101247|NCT03104400|147752052|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|39.8|||<|0.0001|TWO_SIDED|95.0|28.8|50.9||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||50.9|28.8|<0.0001
74101248|NCT03104400|147752053|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|0.0||||0.897|TWO_SIDED|95.0|-0.3|0.3||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||0.3|-0.3|0.8970
74101249|NCT03104400|147752053|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.5||||0.0028|TWO_SIDED|95.0|-0.7|-0.2||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.2|-0.7|0.0028
74101250|NCT03104400|147752054|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.08||||0.0162|TWO_SIDED|95.0|-0.15|-0.01||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.01|-0.15|0.0162
74101251|NCT03104400|147752054|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.14|||<|0.0001|TWO_SIDED|95.0|-0.2|-0.07||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.07|-0.20|<0.0001
74101252|NCT03104400|147752055|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-17.1|||<|0.0001|TWO_SIDED|95.0|-19.6|-14.6||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-14.6|-19.6|<0.0001
74101253|NCT03104400|147752055|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-19.8|||<|0.0001|TWO_SIDED|95.0|-22.3|-17.3||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-17.3|-22.3|<0.0001
74101254|NCT03104400|147752056|OTHER||Response Rate Difference|24.3|||<|0.0001|TWO_SIDED|95.0|18.7|29.9||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.9|18.7|<0.0001
74101255|NCT03104400|147752056|OTHER||Response Rate Difference|38.5|||<|0.0001|TWO_SIDED|95.0|32.8|44.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||44.3|32.8|<0.0001
73881799|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.3989|TWO_SIDED|95.0|-0.75|0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.30|-0.75|0.3989
74101256|NCT03104400|147752057|OTHER||Response Rate Difference|13.3|||<|0.0001|TWO_SIDED|95.0|9.5|17.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||17.0|9.5|<0.0001
74101257|NCT03104400|147752057|OTHER||Response Rate Difference|22.9|||<|0.0001|TWO_SIDED|95.0|18.5|27.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||27.3|18.5|<0.0001
73881800|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.6094|TWO_SIDED|95.0|-0.66|0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.39|-0.66|0.6094
73881801|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5229|TWO_SIDED|95.0|-0.35|0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.69|-0.35|0.5229
74058331|NCT05153629|147668776|OTHER|||||||0.28||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in abdominal/groin pain.||||0.28
74058332|NCT05153629|147668776|OTHER|||||||0.39||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in pain frequency.||||0.39
74058333|NCT05153629|147668776|OTHER|||||||0.26||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in nausea intensity.||||0.26
74058334|NCT05153629|147668777|OTHER|||||||0.5||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||||||0.50
74058335|NCT05153629|147668778|OTHER|||||||0.5||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||||||0.50
74058336|NCT05153629|147668779|OTHER|||||||0.8||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of overall USDT score.||||0.80
74058337|NCT05153629|147668779|OTHER|||||||0.72||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of urinary symptoms.||||0.72
74058338|NCT05153629|147668779|OTHER|||||||0.45||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of pain.||||0.45
74058339|NCT05153629|147668779|OTHER|||||||0.42||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of daily life.||||0.42
74058340|NCT05153629|147668779|OTHER|||||||0.36||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of sexual life.||||0.36
74058341|NCT05153629|147668779|OTHER|||||||0.49||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of medical care/analgesic use.||||0.49
74058342|NCT05153629|147668779|OTHER|||||||0.88||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of overall quality of life.||||0.88
74058343|NCT03743571|147668789|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.42||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.67, p = 0.42||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.42
74058344|NCT03743571|147668790|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.88||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.02, p = .88.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.88
73881802|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4409|TWO_SIDED|95.0|-0.31|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.72|-0.31|0.4409
73881803|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.8062|TWO_SIDED|95.0|-0.45|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.58|-0.45|0.8062
73881804|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3663|TWO_SIDED|95.0|-0.71|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.26|-0.71|0.3663
74101258|NCT03104400|147752058|OTHER||Response Rate Difference|16.1|||<|0.0001|TWO_SIDED|95.0|10.9|21.4||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||21.4|10.9|<0.0001
74101259|NCT03104400|147752058|OTHER||Response Rate Difference|26.2|||<|0.0001|TWO_SIDED|95.0|20.7|31.8||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||31.8|20.7|<0.0001
74101260|NCT02129608|147752080|SUPERIORITY_OR_OTHER|||||||0.398|||||||t-test, 2 sided|||||||0.398
74101261|NCT02129608|147752080|SUPERIORITY_OR_OTHER|||||||0.436|||||||t-test, 2 sided|||||||0.436
74101262|NCT02129608|147752081|SUPERIORITY_OR_OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.070
74101263|NCT02129608|147752081|SUPERIORITY_OR_OTHER|||||||0.95|||||||t-test, 2 sided|||||||0.950
74101264|NCT02661217|147752116|SUPERIORITY||Risk Ratio (RR)|0.896||||0.099|TWO_SIDED|95.0|0.786|1.021|||Cochran-Mantel-Haenszel|||||1.021|0.786|0.099
74101265|NCT02661217|147752117|SUPERIORITY||Risk Ratio (RR)|0.906||||0.034|TWO_SIDED|95.0|0.827|0.993|||Cochran-Mantel-Haenszel|||||0.993|0.827|0.034
74101266|NCT02661217|147752118|SUPERIORITY||Risk Ratio (RR)|0.96||||0.089|TWO_SIDED|95.0|0.916|1.006|||Cochran-Mantel-Haenszel|||||1.006|0.916|0.089
73881805|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0424|TWO_SIDED|95.0|-0.99|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||-0.02|-0.99|0.0424
73881806|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.1597|TWO_SIDED|95.0|-0.85|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.14|-0.85|0.1597
74101267|NCT03593395|147752121|OTHER|Estimation only|Least Square Mean Estimate|2.46|||||TWO_SIDED|95.0|1.81|3.34|||||Estimates are from generalized linear mixed model with a negative binomial distribution log link construct and length of follow up offset. Includes fixed effects for site size, baseline acute utilization, and random effect for cluster (site).|||3.34|1.81|
74101268|NCT03593395|147752121|OTHER|Estimation only.|Least Square Mean Estimate|2.96|||||TWO_SIDED|95.0|2.09|4.19|||||Estimates are from generalized linear mixed model with a negative binomial distribution log link construct and length of follow up offset. Includes fixed effects for site size, baseline acute utilization, and random effect for cluster (site).|||4.19|2.09|
74101269|NCT05044195|147752145|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: upper limit (UL) of the 95% confidence interval (CI) for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.802|||||TWO_SIDED|95.0|0.738|0.871||||||A/H1N1||0.871|0.738|
74101270|NCT05044195|147752145|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.9|||||TWO_SIDED|95.0|0.819|0.989||||||A/H3N2||0.989|0.819|
74101271|NCT05044195|147752145|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.944|||||TWO_SIDED|95.0|0.88|1.012||||||B/Yamagata||1.012|0.880|
74101272|NCT05044195|147752145|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.992|||||TWO_SIDED|95.0|0.923|1.067||||||B/Victoria||1.067|0.923|
74101273|NCT05044195|147752146|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-4.4|||||TWO_SIDED|95.0|-7.97|-0.74||||||A/H1N1||-0.74|-7.97|
74101274|NCT05044195|147752146|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-1.8|||||TWO_SIDED|95.0|-6.14|2.48||||||A/H3N2||2.48|-6.14|
74101275|NCT05044195|147752146|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-2.4|||||TWO_SIDED|95.0|-6.77|2.0||||||B/Yamagata||2.00|-6.77|
74101276|NCT05044195|147752146|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-3.9|||||TWO_SIDED|95.0|-8.31|0.45||||||B/Victoria||0.45|-8.31|
74101277|NCT05044195|147752147|SUPERIORITY||GMT ratio|0.808|||||TWO_SIDED|95.0|0.745|0.876||||||A/H1N1||0.876|0.745|
74101278|NCT05044195|147752147|SUPERIORITY||GMT ratio|0.91|||||TWO_SIDED|95.0|0.829|0.998||||||A/H3N2||0.998|0.829|
74101279|NCT05044195|147752147|SUPERIORITY||GMT ratio|0.947|||||TWO_SIDED|95.0|0.884|1.014||||||B/Yamagata||1.014|0.884|
74101280|NCT05044195|147752147|SUPERIORITY||GMT ratio|1.0|||||TWO_SIDED|95.0|0.931|1.075||||||B/Victoria||1.075|0.931|
74101281|NCT05044195|147752148|OTHER||GMT ratio|0.87|||||TWO_SIDED|95.0|0.803|0.944||||||A/H1N1||0.944|0.803|
74101282|NCT05044195|147752148|OTHER||GMT ratio|0.953|||||TWO_SIDED|95.0|0.88|1.032||||||A/H3N2||1.032|0.880|
74101283|NCT05044195|147752148|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.953|1.077||||||B/Yamagata||1.077|0.953|
74101284|NCT05044195|147752148|OTHER||GMT ratio|1.028|||||TWO_SIDED|95.0|0.963|1.098||||||B/Victoria||1.098|0.963|
74101285|NCT05044195|147752156|OTHER||GMT ratio|0.838|||||TWO_SIDED|95.0|0.751|0.936||||||A/H1N1 (50 to 59 years)||0.936|0.751|
74101286|NCT05044195|147752156|OTHER||GMT ratio|0.924|||||TWO_SIDED|95.0|0.821|1.04||||||A/H3N2 (50 to 59 years)||1.040|0.821|
74101287|NCT05044195|147752156|OTHER||GMT ratio|0.926|||||TWO_SIDED|95.0|0.845|1.015||||||B/Yamagata (50 to 59 years)||1.015|0.845|
74101288|NCT05044195|147752156|OTHER||GMT ratio|0.989|||||TWO_SIDED|95.0|0.901|1.087||||||B/Victoria (50 to 59 years)||1.087|0.901|
73888204|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|82.8||||0.0004|TWO_SIDED|95.0|37.8|127.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||127.7|37.8|0.0004
74101289|NCT05044195|147752156|OTHER||GMT ratio|0.767|||||TWO_SIDED|95.0|0.681|0.864||||||A/H1N1 (60 to 64 years)||0.864|0.681|
74101290|NCT05044195|147752156|OTHER||GMT ratio|0.89|||||TWO_SIDED|95.0|0.766|1.033||||||A/H3N2 (60 to 64 years)||1.033|0.766|
74101291|NCT05044195|147752156|OTHER||GMT ratio|0.974|||||TWO_SIDED|95.0|0.879|1.079||||||B/Yamagata (60 to 64 years)||1.079|0.879|
74101292|NCT05044195|147752156|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.905|1.133||||||B/Victoria (60 to 64 years)||1.133|0.905|
74101293|NCT05044195|147752157|OTHER||GMT ratio|0.844|||||TWO_SIDED|95.0|0.761|0.935||||||A/H1N1 (yes)||0.935|0.761|
74101294|NCT05044195|147752157|OTHER||GMT ratio|1.01|||||TWO_SIDED|95.0|0.904|1.128||||||A/H3N2 (yes)||1.128|0.904|
74101295|NCT05044195|147752157|OTHER||GMT ratio|0.948|||||TWO_SIDED|95.0|0.883|1.016||||||B/Yamagata (yes)||1.016|0.883|
74101296|NCT05044195|147752157|OTHER||GMT ratio|0.997|||||TWO_SIDED|95.0|0.926|1.073||||||B/Victoria (yes)||1.073|0.926|
74101297|NCT05044195|147752157|OTHER||GMT ratio|0.772|||||TWO_SIDED|95.0|0.677|0.88||||||A/H1N1 (no)||0.880|0.677|
74101298|NCT05044195|147752157|OTHER||GMT ratio|0.801|||||TWO_SIDED|95.0|0.683|0.941||||||A/H3N2 (no)||0.941|0.683|
74101299|NCT05044195|147752157|OTHER||GMT ratio|0.945|||||TWO_SIDED|95.0|0.831|1.076||||||B/Yamagata (no)||1.076|0.831|
74101300|NCT05044195|147752157|OTHER||GMT ratio|1.007|||||TWO_SIDED|95.0|0.881|1.151||||||B/Victoria (no)||1.151|0.881|
74101301|NCT05044195|147752158|OTHER||GMT ratio|0.82|||||TWO_SIDED|95.0|0.752|0.894||||||A/H1N1 (Comorbidity Risk Score \<50)||0.894|0.752|
74101302|NCT05044195|147752158|OTHER||GMT ratio|0.933|||||TWO_SIDED|95.0|0.846|1.029||||||A/H3N2 (Comorbidity Risk Score \<50)||1.029|0.846|
74101303|NCT05044195|147752158|OTHER||GMTratio|0.972|||||TWO_SIDED|95.0|0.904|1.046||||||B/Yamagata (Comorbidity Risk Score \<50)||1.046|0.904|
74101304|NCT05044195|147752158|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.938|1.094||||||B/Victoria (Comorbidity Risk Score \<50)||1.094|0.938|
74101305|NCT05044195|147752158|OTHER||GMT ratio|0.706|||||TWO_SIDED|95.0|0.553|0.902||||||A/H1N1 (Comorbidity Risk Score ≥50)||0.902|0.553|
74101306|NCT05044195|147752158|OTHER||GMT ratio|0.734|||||TWO_SIDED|95.0|0.549|0.982||||||A/H3N2 (Comorbidity Risk Score ≥50)||0.982|0.549|
74101307|NCT05044195|147752158|OTHER||GMT ratio|0.773|||||TWO_SIDED|95.0|0.638|0.935||||||B/Yamagata (Comorbidity Risk Score ≥50)||0.935|0.638|
74101308|NCT05044195|147752158|OTHER||GMT ratio|0.905|||||TWO_SIDED|95.0|0.739|1.107||||||B/Victoria (Comorbidity Risk Score ≥50)||1.107|0.739|
74101309|NCT02604407|147752161|SUPERIORITY_OR_OTHER_LEGACY||Difference of LS Mean|-8.1|||<|0.001|TWO_SIDED|95.0|-11.7|-4.4|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 12.5 mg and Placebo.|||-4.4|-11.7|<0.001
74101310|NCT02604407|147752161|SUPERIORITY_OR_OTHER_LEGACY||Difference of LS Mean|-13.4|||<|0.001|TWO_SIDED|95.0|-17.1|-9.7|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 37.5 mg and Placebo.|||-9.7|-17.1|<0.001
74101311|NCT04238650|147752184|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|||||TWO_SIDED|90.0|0.981|1.11||||||||1.11|0.981|
74101312|NCT04238650|147752185|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.13|||||TWO_SIDED|90.0|1.03|1.24||||||||1.24|1.03|
74101313|NCT04238650|147752186|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUClast was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.05|||||TWO_SIDED|90.0|0.997|1.11||||||||1.11|0.997|
74101314|NCT03277066|147752201|SUPERIORITY||Lest-Squared Mean Differences|0.011||||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.0110
74101315|NCT03277066|147752201|SUPERIORITY||Lest-Squared Mean Differences|0.2835||||0.2835|TWO_SIDED||||||Mixed Models Analysis|||||||0.2835
74101316|NCT02585778|147752283|SUPERIORITY||LS Mean Difference|-47.8|||<|0.0001|TWO_SIDED|95.0|-60.7|-35.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-35.0|-60.7|<0.0001
74101317|NCT02585778|147752283|SUPERIORITY||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|95.0|-54.4|-43.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-43.6|-54.4|<0.0001
74058345|NCT03743571|147668791|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.17||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 1.98, p = .17||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.17
74058346|NCT03743571|147668792|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.42||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.67, p = 0.42.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.42
74101318|NCT02585778|147752285|SUPERIORITY||LS Mean Difference|-50.6|||<|0.0001|TWO_SIDED|95.0|-63.4|-37.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level. Hierarchical testing procedure was followed for T1DM and T2DM participants separately.||-37.9|-63.4|<0.0001
74101319|NCT02585778|147752285|SUPERIORITY||LS Mean Difference|-51.6|||<|0.0001|TWO_SIDED|95.0|-56.9|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-46.4|-56.9|<0.0001
74101320|NCT02585778|147752286|SUPERIORITY||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-61.2|-35.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-35.5|-61.2|<0.0001
74058347|NCT03743571|147668793|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.88||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.02, p = .88.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.88
74058348|NCT03743571|147668794|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.17||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 1.98, p = .17.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.17
74058349|NCT03743571|147668795|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).||||||0.67||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) = 0.19, p = .67||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.67
74058350|NCT03743571|147668796|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).||||||0.96||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) \< .01, p = .96||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.96
74101321|NCT02585778|147752286|SUPERIORITY||LS Mean Difference|-45.7|||<|0.0001|TWO_SIDED|95.0|-50.9|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-40.4|-50.9|<0.0001
73881807|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0595|TWO_SIDED|95.0|-0.97|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.02|-0.97|0.0595
73881808|NCT03192176|147297636|SUPERIORITY||LSMean differnce|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.2162|TWO_SIDED|95.0|-0.8|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.18|-0.80|0.2162
74058351|NCT03743571|147668797|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham),||||||0.43||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) = 0.65, p = .43||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.43
74058352|NCT04115488|147668798|EQUIVALENCE|Data was analyzed using a negative binomial model with a logarithmic link function and fixed effects for the treatment group and stratification factors. Equivalence was tested based 95% confidence interval.|Exponentiated Difference|0.17|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|95.0|-0.613|0.944|||||Difference calculated as Tysabri minus PB006.|||0.944|-0.613|
74058353|NCT00972309|147668839|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
74058354|NCT00948896|147668842|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.||||<0.0001
74058355|NCT00948896|147668842|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm.||||<0.01
74058356|NCT00948896|147668842|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm.||||<0.01
74058357|NCT00948896|147668842|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of thrombocytopenia adverse events per PYAR between the control arm and the monthly DP arm.||||<0.05
74101322|NCT02585778|147752287|SUPERIORITY||LS Mean Difference|-44.8|||<|0.0001|TWO_SIDED|95.0|-56.9|-32.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-32.8|-56.9|<0.0001
73881809|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9833|TWO_SIDED|95.0|-0.49|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.48|-0.49|0.9833
74058358|NCT00948896|147668842|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.||||<0.05
74058359|NCT00948896|147668842|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm||||<0.05
74058360|NCT00948896|147668842|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm||||<0.05
74058361|NCT00948896|147668842|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Daily TS arm compare with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the daily TS arm||||<0.01
74058362|NCT00948896|147668844|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|7.0||||0.57|TWO_SIDED|95.0|-19.0|28.0|||Negative Binomial Regression||The no chemoprevention arm is the reference group.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||28|-19|0.57
74058363|NCT00948896|147668844|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|28.0||||0.01|TWO_SIDED|95.0|7.0|44.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||44|7|0.01
74101323|NCT02585778|147752287|SUPERIORITY||LS Mean Difference|-50.2|||<|0.0001|TWO_SIDED|95.0|-55.2|-45.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-45.3|-55.2|<0.0001
74058364|NCT00948896|147668844|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|58.0|||<|0.001|TWO_SIDED|95.0|45.0|67.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||67|45|<0.001
74058365|NCT00948896|147668845|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|9.0||||0.065|TWO_SIDED|95.0|-35.0|38.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||38|-35|0.065
74058366|NCT00948896|147668845|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|49.0||||0.001|TWO_SIDED|95.0|23.0|66.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||66|23|0.001
74058367|NCT00948896|147668845|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|69.0|||<|0.001|TWO_SIDED|95.0|53.0|80.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||80|53|<0.001
74058368|NCT05405218|147668945|SUPERIORITY||Mean Difference (Net)|0.08||||0.46|TWO_SIDED|95.0|-0.13|0.29|||Mixed Models Analysis|||||0.29|-0.13|0.46
74058369|NCT05405218|147668946|SUPERIORITY||Mean Difference (Net)|0.01||||0.92|TWO_SIDED|95.0|-0.2|0.23|||Mixed Models Analysis|||||0.23|-0.2|0.92
74058370|NCT05405218|147668948|SUPERIORITY||Mean Difference (Net)|0.61||||0.09|TWO_SIDED|95.0|-0.08|1.3|||Mixed Models Analysis|||||1.3|-0.08|0.09
74058371|NCT05405218|147668949|SUPERIORITY||Mean Difference (Net)|0.0||||0.9|TWO_SIDED|95.0|-0.06|0.05|||Mixed Models Analysis|||||0.05|-0.06|0.9
74058372|NCT05436067|147669000|OTHER||||||<|0.001||||||Difference in head angle pitch - left between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
74058373|NCT05436067|147669000|OTHER||||||<|0.001||||||Difference in head angle pitch - right between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
74058374|NCT05436067|147669000|OTHER|||||||0.042||||||Difference in head angle yaw - extension between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.042
74058375|NCT05436067|147669000|OTHER|||||||0.111||||||Difference in head angle yaw - flexion between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.111
74058376|NCT05436067|147669001|OTHER|||||||0.023||||||Difference in pitch range of motion between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.023
74058377|NCT05436067|147669001|OTHER||||||<|0.001|||||||paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
74058378|NCT05436067|147669002|OTHER|||||||0.057||||||Difference in pitch velocity between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.057
74058379|NCT05436067|147669002|OTHER|||||||0.003||||||Difference in yaw velocity between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.003
74058380|NCT05436067|147669003|OTHER|||||||0.035||||||Weight shift exercise - mediolateral range of motion|paired t-test|||||||0.035
74058381|NCT05436067|147669003|OTHER|||||||0.006||||||Weight shift balance exercise anteroposterior range of motion|paired t-test|||||||0.006
74058382|NCT05436067|147669003|OTHER|||||||0.024||||||Single leg balance range of motion|paired t-test|||||||0.024
74058383|NCT05436067|147669003|OTHER|||||||0.257||||||Single leg balance fluency|Shapiro Wilcoxon test|Data was not normally distributed.||||||0.257
74058384|NCT05689554|147669011|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.11|TWO_SIDED|95.0|0.944|1.306|||Log Rank|||||1.306|.944|0.11
74058385|NCT05689554|147669012|SUPERIORITY||Risk Ratio (RR)|1.24||||0.183|TWO_SIDED|95.0|0.9|1.7|||Regression, modified Poisson|||||1.7|.9|0.183
74058386|NCT00563706|147669014|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-12.3||||0.043|TWO_SIDED|95.0|-24.24|-0.37|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||-0.37|-24.24|0.043
74058387|NCT00563706|147669014|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.77||||0.457|TWO_SIDED|95.0|-24.7|11.16|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||11.16|-24.70|0.457
74058388|NCT00563706|147669014|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.61||||0.067|TWO_SIDED|95.0|-24.03|0.81|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||0.81|-24.03|0.067
74058389|NCT00563706|147669014|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.61||||0.567|TWO_SIDED|95.0|-16.02|8.8|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||8.80|-16.02|0.567
74058390|NCT00563706|147669014|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.9||||0.07|TWO_SIDED|95.0|-22.71|0.92|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||0.92|-22.71|0.070
74058391|NCT00563706|147669014|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.18||||0.647|TWO_SIDED|95.0|-16.87|10.5|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||10.50|-16.87|0.647
74058392|NCT00563706|147669014|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73||||0.075|TWO_SIDED|95.0|-20.46|1.0|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||1.00|-20.46|0.075
74058393|NCT00563706|147669014|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.44||||0.765|TWO_SIDED|95.0|-10.92|8.04|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||8.04|-10.92|0.765
74058394|NCT03965754|147669043|SUPERIORITY||Odds Ratio (OR)|5.96|||<|0.001|TWO_SIDED|95.0|4.0|9.18||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||9.18|4.00|<.001
74101324|NCT02585778|147752288|SUPERIORITY||LS Mean Difference|-42.7|||<|0.0001|TWO_SIDED|95.0|-54.9|-30.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-30.5|-54.9|<0.0001
74101325|NCT02585778|147752288|SUPERIORITY||LS Mean Difference|-44.1|||<|0.0001|TWO_SIDED|95.0|-49.0|-39.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-39.2|-49.0|<0.0001
74058395|NCT03965754|147669043|SUPERIORITY||Odds Ratio (OR)|5.02|||<|0.001|TWO_SIDED|95.0|3.36|7.76||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||7.76|3.36|<.001
74058396|NCT03965754|147669043|SUPERIORITY||Odds Ratio (OR)|3.3|||<|0.001|TWO_SIDED|95.0|2.17|5.17||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||5.17|2.17|<.001
74058397|NCT03965754|147669043|SUPERIORITY||Odds Ratio (OR)|3.28||||0.038|TWO_SIDED|95.0|1.16|11.71||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||11.71|1.16|.038
74058398|NCT03965754|147669043|SUPERIORITY||Odds Ratio (OR)|2.01||||0.256|TWO_SIDED|95.0|0.63|7.54||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||7.54|0.63|.256
74058399|NCT03965754|147669043|SUPERIORITY||Odds Ratio (OR)|1.5||||0.531|TWO_SIDED|95.0|0.43|5.89||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||5.89|0.43|.531
74058400|NCT03965754|147669043|SUPERIORITY||Odds Ratio (OR)|1.19||||0.202|TWO_SIDED|95.0|0.91|1.54||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled in the program).||1.54|0.91|.202
74058401|NCT03965754|147669043|SUPERIORITY||Odds Ratio (OR)|0.66||||0.005|TWO_SIDED|95.0|0.49|0.88||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled in the program).||0.88|0.49|.005
74058402|NCT03965754|147669043|SUPERIORITY||Odds Ratio (OR)|0.75||||0.276|TWO_SIDED|95.0|0.69|4.16||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled in the program).||4.16|0.69|.276
74058403|NCT03965754|147669043|SUPERIORITY||Odds Ratio (OR)|0.75||||0.592|TWO_SIDED|95.0|0.25|2.16||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled in the program).||2.16|0.25|.592
74058404|NCT03965754|147669044|SUPERIORITY|We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled).|Odds Ratio (OR)|1.31||||0.02|TWO_SIDED|95.0|1.04|1.65||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.65|1.04|.020
74101326|NCT02585778|147752289|SUPERIORITY||LS Mean Difference|-42.7|||<|0.0001|TWO_SIDED|95.0|-54.2|-31.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-31.3|-54.2|<0.0001
74058405|NCT03965754|147669044|SUPERIORITY||Odds Ratio (OR)|0.58|||<|0.001|TWO_SIDED|95.0|0.44|0.75||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled).||0.75|0.44|<.001
74058406|NCT03965754|147669044|SUPERIORITY||Odds Ratio (OR)|0.75||||0.359|TWO_SIDED|95.0|0.41|1.38||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled).||1.38|0.41|.359
74058407|NCT03965754|147669044|SUPERIORITY|We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled).|Odds Ratio (OR)|1.72||||0.035|TWO_SIDED|95.0|1.05|2.9|||Regression, Logistic|We used an a priori threshold of p \< .05.||||2.90|1.05|.035
74058408|NCT02983305|147669045|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.0001||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area at baseline.||||.0001
74058409|NCT02983305|147669045|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.0001||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area under intervention conditions.||||0.0001
74058410|NCT02983305|147669045|EQUIVALENCE|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.003||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the visual field area (average of both eyes) detected between baseline and intervention.||||.003
74058411|NCT02983305|147669046|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.38||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed at baseline.||||0.38
74058412|NCT02983305|147669046|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.27||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed under intervention conditions.||||0.27
74058413|NCT02983305|147669046|EQUIVALENCE|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.79||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the gait speed detected between baseline and intervention.||||0.79
74058414|NCT03433482|147669048|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% confidence interval (CI) for the hSBA GMT ratio for serogroup A between the MenACWY liquid vaccine aged for approximately 24 months and the licensed MenACWY vaccine is \> 0.5.|GMT ratio|1.21|||||TWO_SIDED|95.0|0.94|1.57|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 24 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination||1.57|0.94|
74058415|NCT03433482|147669048|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratios for serogroup A between the MenACWY liquid vaccine aged for approximately 30 months and the licensed MenACWY vaccine is \> 0.5. Non-inferiority hypotheses testing will be conducted sequentially, starting from MenACWY liquid vaccine aged for approximately 24 months and subsequently with MenACWY liquid vaccine aged for approximately 30 months.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.87|1.42|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 30 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination.||1.42|0.87|
74058416|NCT03433482|147669049|OTHER||GMT ratio|0.84|||||TWO_SIDED|95.0|0.58|1.19|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup C||1.19|0.58|
74058417|NCT03433482|147669049|OTHER||GMT ratio|0.94|||||TWO_SIDED|95.0|0.72|1.24|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup W||1.24|0.72|
74058418|NCT03433482|147669049|OTHER||GMT ratio|1.09|||||TWO_SIDED|95.0|0.82|1.44|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup Y||1.44|0.82|
74058419|NCT03433482|147669049|OTHER||GMT ratio|1.14|||||TWO_SIDED|95.0|0.79|1.64|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup C||1.64|0.79|
73881810|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.2034|TWO_SIDED|95.0|-0.81|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.17|-0.81|0.2034
74058420|NCT03433482|147669049|OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.84|1.45|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup W||1.45|0.84|
73881811|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9576|TWO_SIDED|95.0|-0.7|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.67|-0.70|0.9576
74058421|NCT03433482|147669049|OTHER||GMT ratio|0.96|||||TWO_SIDED|95.0|0.72|1.26|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup Y||1.26|0.72|
74058422|NCT03433482|147669051|OTHER||Difference in percentage of subjects|2.21|||||TWO_SIDED|95.0|-1.94|6.4|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||6.40|-1.94|
74058423|NCT03433482|147669051|OTHER||Difference in percentage of subjects|-2.12|||||TWO_SIDED|95.0|-8.94|4.72|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||4.72|-8.94|
74058424|NCT03433482|147669051|OTHER||Difference in percentage of subjects|-1.16|||||TWO_SIDED|95.0|-8.11|5.8|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||5.80|-8.11|
74058425|NCT03433482|147669051|OTHER||Difference in percentage of subjects|-1.57|||||TWO_SIDED|95.0|-7.88|4.74|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||4.74|-7.88|
74058426|NCT03433482|147669051|OTHER||Difference in percentage of subjects|-0.12|||||TWO_SIDED|95.0|-4.29|4.07|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||4.07|-4.29|
74058427|NCT03433482|147669051|OTHER||Difference in percentage of subjects|2.85|||||TWO_SIDED|95.0|-3.63|9.3|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||9.30|-3.63|
74058428|NCT03433482|147669051|OTHER||Difference in percentage of subjects|4.01|||||TWO_SIDED|95.0|-2.89|10.88|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||10.88|-2.89|
74058429|NCT03433482|147669051|OTHER||Difference in percentage of subjects|-2.84|||||TWO_SIDED|95.0|-8.91|3.26|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||3.26|-8.91|
74058430|NCT03433482|147669052|OTHER||Difference in percentage of subjects|1.79|||||TWO_SIDED|95.0|-2.69|6.32|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.||6.32|-2.69|
74058431|NCT03433482|147669052|OTHER||Difference in percentage of subjects|6.96|||||TWO_SIDED|95.0|0.01|13.84|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.||13.84|0.01|
74058432|NCT03433482|147669052|OTHER||Difference in percentage of subjects|3.13|||||TWO_SIDED|95.0|-3.33|9.58|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.||9.58|-3.33|
74058433|NCT03433482|147669052|OTHER||Difference in percentage of subjects|0.96|||||TWO_SIDED|95.0|-4.86|6.8|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.||6.80|-4.86|
74058434|NCT03433482|147669052|OTHER||Difference in percentage of subjects|1.46|||||TWO_SIDED|95.0|-2.24|5.22|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.||5.22|-2.24|
74058435|NCT03433482|147669052|OTHER||Difference in percentage of subjects|-0.43|||||TWO_SIDED|95.0|-6.32|5.46|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.||5.46|-6.32|
74058436|NCT03433482|147669052|OTHER||Difference in percentage of subjects|-1.43|||||TWO_SIDED|95.0|-7.05|4.18|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 29.||4.18|-7.05|
74058437|NCT03433482|147669052|OTHER||Difference in percentage of subjects|2.04|||||TWO_SIDED|95.0|-2.81|6.9|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.||6.90|-2.81|
74058438|NCT03433482|147669052|OTHER||Difference in percentage of subjects|1.5|||||TWO_SIDED|95.0|-3.32|6.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.||6.33|-3.32|
74058439|NCT03433482|147669052|OTHER||Difference in percentage of subjects|0.38|||||TWO_SIDED|95.0|-6.6|7.35|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.||7.35|-6.60|
74058440|NCT03433482|147669052|OTHER||Difference in percentage of subjects|-1.26|||||TWO_SIDED|95.0|-7.75|5.23|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.||5.23|-7.75|
74058441|NCT03433482|147669052|OTHER||Difference in percentage of subjects|-0.85|||||TWO_SIDED|95.0|-6.69|4.98|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.||4.98|-6.69|
74058442|NCT03433482|147669052|OTHER||Difference in percentage of subjects|-0.64|||||TWO_SIDED|95.0|-4.24|2.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.||2.96|-4.24|
74058443|NCT03433482|147669052|OTHER||Difference in percentage of subjects|1.32|||||TWO_SIDED|95.0|-3.99|6.64|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.||6.64|-3.99|
74058444|NCT03433482|147669052|OTHER||Difference in percentage of subjects|4.09|||||TWO_SIDED|95.0|-1.11|9.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 the N. meningitidis serogroup W on Day 29.||9.33|-1.11|
74058445|NCT03433482|147669052|OTHER||Difference in percentage of subjects|0.48|||||TWO_SIDED|95.0|-4.16|5.13|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.||5.13|-4.16|
74058446|NCT03433482|147669053|OTHER||Difference in percentage of subjects|1.29|||||TWO_SIDED|95.0|-3.37|5.99|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||5.99|-3.37|
74058447|NCT03433482|147669053|OTHER||Difference in percentage of subjects|7.23|||||TWO_SIDED|95.0|0.25|14.13|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||14.13|0.25|
74058448|NCT03433482|147669053|OTHER||Difference in percentage of subjects|3.92|||||TWO_SIDED|95.0|-2.57|10.39|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||10.39|-2.57|
74058449|NCT03433482|147669053|OTHER||Difference in percentage of subjects|1.49|||||TWO_SIDED|95.0|-4.44|7.44|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||7.44|-4.44|
74058450|NCT03433482|147669053|OTHER||Difference in percentage of subjects|1.73|||||TWO_SIDED|95.0|-1.94|5.46|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||5.46|-1.94|
74058451|NCT03433482|147669053|OTHER||Difference in percentage of subjects|-0.99|||||TWO_SIDED|95.0|-6.66|4.7|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||4.70|-6.66|
74058452|NCT03433482|147669053|OTHER||Difference in percentage of subjects|-1.43|||||TWO_SIDED|95.0|-7.05|4.18|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||4.18|-7.05|
74058453|NCT03433482|147669053|OTHER||Difference in percentage of subjects|2.06|||||TWO_SIDED|95.0|-2.67|6.8|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||6.80|-2.67|
74058454|NCT03433482|147669053|OTHER||Difference in percentage of subjects|1.75|||||TWO_SIDED|95.0|-3.32|6.83|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||6.83|-3.32|
74058455|NCT03433482|147669053|OTHER||Difference in percentage of subjects|3.87|||||TWO_SIDED|95.0|-3.0|10.71|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||10.71|-3.00|
74058456|NCT03433482|147669053|OTHER||Difference in percentage of subjects|-0.73|||||TWO_SIDED|95.0|-7.24|5.77|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||5.77|-7.24|
74058457|NCT03433482|147669053|OTHER||Difference in percentage of subjects|-1.12|||||TWO_SIDED|95.0|-6.99|4.75|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||4.75|-6.99|
74058458|NCT03433482|147669053|OTHER||Difference in percentage of subjects|-0.64|||||TWO_SIDED|95.0|-4.24|2.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||2.96|-4.24|
74058459|NCT03433482|147669053|OTHER||Difference in percentage of subjects|0.0|||||TWO_SIDED|95.0|-5.16|5.16|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||5.16|-5.16|
74058460|NCT03433482|147669053|OTHER||Difference in percentage of subjects|4.09|||||TWO_SIDED|95.0|-1.11|9.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||9.33|-1.11|
74058461|NCT03433482|147669053|OTHER||Difference in percentage of subjects|0.73|||||TWO_SIDED|95.0|-3.88|5.37|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||5.37|-3.88|
74058462|NCT01646268|147669059|SUPERIORITY_OR_OTHER||LS Means|-4.82|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-7.18|-2.45|||ANCOVA||Value describes the difference value of the mean change from baseline between Rotigotine and Placebo groups. The Value for this outcome was -4.6.|The null hypothesis (H0) is that there is no difference in the change in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+II) between the active treatment and the placebo groups (i.e., the change from Baseline in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+III) is the same for both groups).||-2.45|-7.18|<0.0001
74058463|NCT00461591|147669069|SUPERIORITY||Odds Ratio (OR)|0.76||||0.1068|TWO_SIDED|95.0|0.54|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.54|0.1068
74058464|NCT00461591|147669070|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0412|TWO_SIDED|95.0|0.59|0.99|||Log Rank|||||0.99|0.59|0.0412
74058465|NCT02325414|147669078|SUPERIORITY||Median Difference (Final Values)|10.61||||0.05|TWO_SIDED||||||Mixed Models Analysis||||One-year data analysis were carried out using linear mixed-effects models. Covariate adjustments for baseline value of the corresponding outcome and ambulatory status (measured by WISCI) were performed by fitting these variables as fixed factors. The repeated measures were addressed using participant identification as random intercepts in the model.|||0.05
73881812|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.041|TWO_SIDED|95.0|-1.4|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||-0.03|-1.40|0.0410
74058466|NCT00347776|147669082|SUPERIORITY||Cox Proportional Hazard|0.67||||0.047|TWO_SIDED|95.0|0.45|0.98|||Log Rank|||"The log rank test was done to compare the survival rates between the tetracycline arm and the azithromycin arms combined.~The Cox proportional hazard model was used to evaluate risk factors and adjust for confounding in predicting recurrence."||0.98|0.45|.047
74058467|NCT00347776|147669083|SUPERIORITY|||||||0.19|||||||Log Rank|||"We tried to evaluate if treating the immediate family members of the subject with oral azithromycin along with the subject had added advantage in reducing the rate of recurrent trichiasis in comparison to treating the subject alone with oral azithromycin post surgery.~The log rank test was done to compare the survival rates between the two intervention arms.The comparison results were expressed in person-years."||||0.19
74058468|NCT00347776|147669084|SUPERIORITY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.36|1.1|||Regression, Logistic||Comparison group was the tetracycline group.|Surgery was considered a failure if there was trichiasis recurrence at 6 week follow-up.||1.10|0.36|
74058469|NCT00594568|147669086|SUPERIORITY_OR_OTHER|||||||0.134||95.0|||||Mixed Models Analysis|||||||0.134
74058470|NCT00594568|147669086|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Mixed Models Analysis|||||||0.045
74058471|NCT00594568|147669086|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Mixed Models Analysis|||||||0.610
74058472|NCT00594568|147669087|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Mixed Models Analysis|||||||0.296
74058473|NCT00594568|147669087|SUPERIORITY_OR_OTHER|||||||0.172||95.0|||||Mixed Models Analysis|||||||0.172
74058474|NCT00594568|147669087|SUPERIORITY_OR_OTHER|||||||0.746||95.0|||||Mixed Models Analysis|||||||0.746
74058475|NCT00594568|147669088|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||Mixed Models Analysis|||||||0.166
74058476|NCT00594568|147669088|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
74058477|NCT00594568|147669088|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Mixed Models Analysis|||||||0.014
74058478|NCT00594568|147669089|SUPERIORITY_OR_OTHER|||||||0.935||95.0|||||Mixed Models Analysis|||||||0.935
74058479|NCT00594568|147669089|SUPERIORITY_OR_OTHER|||||||0.068||95.0|||||Mixed Models Analysis|||||||0.068
74058480|NCT00594568|147669089|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Mixed Models Analysis|||||||0.070
74058481|NCT00594568|147669090|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||||||0.002
74101327|NCT02585778|147752289|SUPERIORITY||LS Mean Difference|-38.7|||<|0.0001|TWO_SIDED|95.0|-43.4|-33.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-33.9|-43.4|<0.0001
74058482|NCT00594568|147669090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74058483|NCT00594568|147669090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
74058484|NCT00594568|147669091|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||||||0.038
74058485|NCT00594568|147669091|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||ANCOVA|||||||0.147
74058486|NCT00594568|147669091|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||||||0.604
74058487|NCT00594568|147669092|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.143
74058488|NCT00594568|147669092|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.464
74058489|NCT00594568|147669092|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.025
74058490|NCT00594568|147669092|SUPERIORITY_OR_OTHER|||||||0.347||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.347
73888205|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|39.6||||0.0812|TWO_SIDED|95.0|-5.0|84.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||84.1|-5.0|0.0812
74058491|NCT00594568|147669092|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.820
74058492|NCT00594568|147669092|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.243
74058493|NCT00594568|147669093|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||ANCOVA|||||||0.784
74058494|NCT00594568|147669093|SUPERIORITY_OR_OTHER|||||||0.931||95.0|||||ANCOVA|||||||0.931
74058495|NCT00594568|147669093|SUPERIORITY_OR_OTHER|||||||0.718||95.0|||||ANCOVA|||||||0.718
74058496|NCT00594568|147669094|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||ANCOVA|||||||0.634
74058497|NCT00594568|147669094|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||ANCOVA|||||||0.901
74058498|NCT00594568|147669094|SUPERIORITY_OR_OTHER|||||||0.659||95.0|||||ANCOVA|||||||0.659
74058499|NCT00594568|147669097|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Mixed Models Analysis|||||||0.062
74058500|NCT00594568|147669097|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Mixed Models Analysis|||||||0.022
74058501|NCT00594568|147669097|SUPERIORITY_OR_OTHER|||||||0.669||95.0|||||Mixed Models Analysis|||||||0.669
74058502|NCT00594568|147669098|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||Mixed Models Analysis|||||||0.071
74058503|NCT00594568|147669098|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Mixed Models Analysis|||||||0.018
74058504|NCT00594568|147669098|SUPERIORITY_OR_OTHER|||||||0.571||95.0|||||Mixed Models Analysis|||||||0.571
74058505|NCT00594568|147669099|SUPERIORITY_OR_OTHER|||||||0.518||95.0|||||Mixed Models Analysis|||||||0.518
74101328|NCT02585778|147752290|SUPERIORITY||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-49.4|-28.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-28.7|-49.4|<0.0001
74101329|NCT02585778|147752290|SUPERIORITY||LS Mean Difference|-36.7|||<|0.0001|TWO_SIDED|95.0|-40.9|-32.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-32.5|-40.9|<0.0001
73881813|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3961|TWO_SIDED|95.0|-1.0|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.40|-1.00|0.3961
73881814|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.36||0.5012|TWO_SIDED|95.0|-0.94|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.46|-0.94|0.5012
74058506|NCT00594568|147669099|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Mixed Models Analysis|||||||0.013
74058507|NCT00594568|147669099|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Mixed Models Analysis|||||||0.072
74101330|NCT02585778|147752291|SUPERIORITY||LS Mean Difference|-29.2|||<|0.0001|TWO_SIDED|95.0|-37.8|-20.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-20.7|-37.8|<0.0001
74058508|NCT00594568|147669100|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Mixed Models Analysis|||||||0.069
74058509|NCT00594568|147669100|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||||||0.002
74058510|NCT00594568|147669100|SUPERIORITY_OR_OTHER|||||||0.198||95.0|||||Mixed Models Analysis|||||||0.198
74058511|NCT00594568|147669101|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Mixed Models Analysis|||||||0.127
74058512|NCT00594568|147669101|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Mixed Models Analysis|||||||0.016
74058513|NCT00594568|147669101|SUPERIORITY_OR_OTHER|||||||0.381||95.0|||||Mixed Models Analysis|||||||0.381
74058514|NCT00594568|147669102|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
74058515|NCT00594568|147669102|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|||||||0.005
74058516|NCT00594568|147669102|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Mixed Models Analysis|||||||0.141
73881815|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.2592|TWO_SIDED|95.0|-1.1|0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.30|-1.10|0.2592
73888206|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|35.5||||0.1174|TWO_SIDED|95.0|-9.0|80.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.0|-9.0|0.1174
74058517|NCT00594568|147669103|SUPERIORITY_OR_OTHER|||||||0.337||95.0|||||ANCOVA|||||||0.337
74058518|NCT00594568|147669103|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANCOVA|||||||0.018
74058519|NCT00594568|147669103|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||ANCOVA|||||||0.157
74058520|NCT00594568|147669104|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Mixed Models Analysis|||||||0.186
74058521|NCT00594568|147669104|SUPERIORITY_OR_OTHER|||||||0.149||95.0|||||Mixed Models Analysis|||||||0.149
74058522|NCT00594568|147669104|SUPERIORITY_OR_OTHER|||||||0.889||95.0|||||Mixed Models Analysis|||||||0.889
74058523|NCT00594568|147669105|SUPERIORITY_OR_OTHER|||||||0.202||95.0|||||Mixed Models Analysis|||||||0.202
74058524|NCT00594568|147669105|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Mixed Models Analysis|||||||0.075
74058525|NCT00594568|147669105|SUPERIORITY_OR_OTHER|||||||0.616||95.0|||||Mixed Models Analysis|||||||0.616
74058526|NCT00299546|147669113|SUPERIORITY_OR_OTHER||||||<|0.001||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX)||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Group 1 vs. Combined Groups 2 and 3. A sample size of 140 patients per group provides a \>90% power assuming 50% of patients used Methotrexate (MTX) at baseline and 30% ACR 20 response in placebo and 40\~55% ACR 20 response in golimumab groups.||||<0.001
74058527|NCT00299546|147669113|SUPERIORITY_OR_OTHER|||||||0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 2: 50 mg.||||0.001
74058528|NCT00299546|147669113|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 3 :100 mg.||||<0.001
74058529|NCT00299546|147669114|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).||||||0.003
74058530|NCT00299546|147669114|SUPERIORITY_OR_OTHER|||||||0.021||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.021
74058531|NCT00299546|147669114|SUPERIORITY_OR_OTHER|||||||0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.002
74058532|NCT00299546|147669115|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methorexate (MTX).||||||<0.001
74058533|NCT00299546|147669115|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
74101331|NCT02585778|147752291|SUPERIORITY||LS Mean Difference|-27.6|||<|0.0001|TWO_SIDED|95.0|-31.2|-24.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-24.1|-31.2|<0.0001
74101332|NCT02585778|147752292|SUPERIORITY||Odds Ratio (OR)|117.0|||<|0.0001|TWO_SIDED|95.0|13.1|1041.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||1041.8|13.1|<0.0001
73881816|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.35||0.6141|TWO_SIDED|95.0|-0.51|0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.86|-0.51|0.6141
74058534|NCT00299546|147669115|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
74058535|NCT00299546|147669116|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).||||||<0.001
74058536|NCT00299546|147669116|SUPERIORITY_OR_OTHER|||||||0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.002
74058537|NCT00299546|147669116|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
74058538|NCT00299546|147669117|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|Stratified by baseline Methotrexate (MTX).||||||<0.001
74058539|NCT00299546|147669117|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.||||||<0.001
74058540|NCT00299546|147669117|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.||||||<0.001
74058541|NCT00518531|147669134|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.5||||0.0259|TWO_SIDED|95.0|1.3|19.7||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.|||19.7|1.3|0.0259
74058542|NCT00518531|147669135|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|30.9|||<|0.0001|TWO_SIDED|95.0|20.6|41.3||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.|||41.3|20.6|<0.0001
74058543|NCT00518531|147669136|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.0||||0.0138|TWO_SIDED|95.0|2.2|19.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||19.7|2.2|0.0138
74058544|NCT00518531|147669137|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.7|||<|0.0001|TWO_SIDED|95.0|17.6|37.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||37.7|17.6|<0.0001
74058545|NCT00518531|147669138|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8||||0.0291|TWO_SIDED|95.0|1.1|18.5|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||18.5|1.1|0.0291
74058546|NCT00518531|147669139|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.4|||<|0.0001|TWO_SIDED|95.0|18.1|36.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||36.7|18.1|<0.0001
74058547|NCT03491800|147669157|SUPERIORITY||Mean Difference (Net)|7.5|STANDARD_ERROR_OF_MEAN|0.15||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
74058548|NCT03491800|147669158|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.43||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.90
74058549|NCT03491800|147669158|SUPERIORITY||Mean Difference (Final Values)|4.44|STANDARD_ERROR_OF_MEAN|0.26||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
74058550|NCT03491800|147669159|SUPERIORITY||Mean Difference (Final Values)|-3.03|STANDARD_ERROR_OF_MEAN|-0.28||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
74058551|NCT03491800|147669159|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.22||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
74058552|NCT03491800|147669160|SUPERIORITY||Mean Difference (Final Values)|-5.05|STANDARD_ERROR_OF_MEAN|-0.25||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.21
74058553|NCT03491800|147669161|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
74058554|NCT03491800|147669162|SUPERIORITY||Mean Difference (Final Values)|3.34|STANDARD_ERROR_OF_MEAN|-0.2||0.52|TWO_SIDED||||||t-test, 2 sided|||||||0.52
74058555|NCT03491800|147669163|SUPERIORITY||Mean Difference (Final Values)|-38.25|STANDARD_ERROR_OF_MEAN|-38.25||0.23|TWO_SIDED||||||t-test, 2 sided|||||||0.23
74058556|NCT03491800|147669163|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|22.0||0.67|TWO_SIDED||||||t-test, 2 sided|||||||0.67
74058557|NCT03491800|147669163|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|9.62||0.054|TWO_SIDED||||||t-test, 2 sided|||||||0.054
74058558|NCT03491800|147669164|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|5.4||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
74058559|NCT03491800|147669164|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|3.29||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
74058560|NCT04311411|147669165|SUPERIORITY||Median Difference (Final Values)|-534.11|||<|0.0001|TWO_SIDED|95.0|-668.2|-400.02|||ANCOVA|||||-400.02|-668.20|<.0001
74058561|NCT04311411|147669166|SUPERIORITY||Median Difference (Final Values)|0.0439||||0.5437|TWO_SIDED|95.0|-0.0994|0.1871|||Mixed Models Analysis|||Insula||0.1871|-0.0994|0.5437
74058562|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.1806|TWO_SIDED|95.0|-0.0441|0.2301|||Mixed Models Analysis|||Insula||0.2301|-0.0441|0.1806
74058563|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|-0.0491||||0.472|TWO_SIDED|95.0|-0.1846|0.0863|||Mixed Models Analysis|||Insula||0.0863|-0.1846|0.4720
74058564|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|-0.0011||||0.9842|TWO_SIDED|95.0|-0.1079|0.1058|||Mixed Models Analysis|||Medial frontal gyrus||0.1058|-0.1079|0.9842
73881817|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.439|TWO_SIDED|95.0|-0.95|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.41|-0.95|0.4390
73881818|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4521|TWO_SIDED|95.0|-0.64|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.29|-0.64|0.4521
73881819|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0257|TWO_SIDED|95.0|-0.99|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||-0.06|-0.99|0.0257
73881820|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0564|TWO_SIDED|95.0|-0.93|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.01|-0.93|0.0564
73881821|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0293|TWO_SIDED|95.0|-0.99|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 8: Overall Mean Score||-0.05|-0.99|0.0293
74058565|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|0.0077||||0.8822|TWO_SIDED|95.0|-0.0949|0.1102|||Mixed Models Analysis|||Medial frontal gyrus||0.1102|-0.0949|0.8822
74058566|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|-0.0087||||0.8657|TWO_SIDED|95.0|-0.1111|0.0937|||Mixed Models Analysis|||Medial frontal gyrus||0.0937|-0.1111|0.8657
74058567|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|0.0043||||0.9599|TWO_SIDED|95.0|-0.165|0.1736|||Mixed Models Analysis|||Superior temporal gyrus||0.1736|-0.1650|0.9599
74058568|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|0.0489||||0.549|TWO_SIDED|95.0|-0.1129|0.2107|||Mixed Models Analysis|||Superior temporal gyrus||0.2107|-0.1129|0.5490
74058569|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|-0.0446||||0.5854|TWO_SIDED|95.0|-0.2068|0.1176|||Mixed Models Analysis|||Superior temporal gyrus||0.1176|-0.2068|0.5854
74058570|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|-0.0192||||0.7203|TWO_SIDED|95.0|-0.1259|0.0874|||Mixed Models Analysis|||Precentral gyrus||0.0874|-0.1259|0.7203
74058571|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|0.0404||||0.433|TWO_SIDED|95.0|-0.0617|0.1425|||Mixed Models Analysis|||Precentral gyrus||0.1425|-0.0617|0.4330
74058572|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|-0.0596||||0.2488|TWO_SIDED|95.0|-0.1619|0.0426|||Mixed Models Analysis|||Precentral gyrus||0.0426|-0.1619|0.2488
74058573|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.8886|TWO_SIDED|95.0|-0.1059|0.0919|||Mixed Models Analysis|||Cingulate gyrus||0.0919|-0.1059|0.8886
74058574|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|0.0684||||0.1563|TWO_SIDED|95.0|-0.0267|0.1635|||Mixed Models Analysis|||Cingulate gyrus||0.1635|-0.0267|0.1563
74058575|NCT04311411|147669166|SUPERIORITY||Mean Difference (Final Values)|-0.0754||||0.1182|TWO_SIDED|95.0|-0.1704|0.0196|||Mixed Models Analysis|||Cingulate gyrus||0.0196|-0.1704|0.1182
74058576|NCT04311411|147669167|SUPERIORITY||Mean Difference (Final Values)|20.57|||<|0.0001|TWO_SIDED|95.0|12.11|29.02|||Mixed Models Analysis|||Fasting (Pre-lunch)||29.02|12.11|<.0001
74058577|NCT04311411|147669167|SUPERIORITY||Mean Difference (Final Values)|6.63||||0.1097|TWO_SIDED|95.0|-1.53|14.79||Fasting|Mixed Models Analysis|||Fasting (Pre-lunch)||14.79|-1.53|0.1097
74058578|NCT04311411|147669167|SUPERIORITY||Mean Difference (Final Values)|13.94||||0.0015|TWO_SIDED|95.0|5.49|22.38|||Mixed Models Analysis|||Fasting (Pre-lunch)||22.38|5.49|0.0015
74058579|NCT04311411|147669167|SUPERIORITY||Mean Difference (Final Values)|2.25||||0.4469|TWO_SIDED|95.0|-3.6|8.09|||Mixed Models Analysis|||Postprandial (Post-lunch)||8.09|-3.60|0.4469
74058580|NCT04311411|147669167|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.8227|TWO_SIDED|95.0|-5.02|6.31|||Mixed Models Analysis|||Postprandial (Post-lunch)||6.31|-5.02|0.8227
74058581|NCT04311411|147669167|SUPERIORITY||Mean Difference (Final Values)|1.61||||0.5861|TWO_SIDED|95.0|-4.23|7.45|||Mixed Models Analysis|||Postprandial (Post-lunch)||7.45|-4.23|0.5861
73881822|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.3742|TWO_SIDED|95.0|-0.68|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.26|-0.68|0.3742
73881823|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.9106|TWO_SIDED|95.0|-0.49|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.44|-0.49|0.9106
73881824|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23||0.1844|TWO_SIDED|95.0|-0.78|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean SCore||0.15|-0.78|0.1844
74058582|NCT03722849|147669199|OTHER||||||=|0.0028||||||No multiple comparisons as region of interest analysis defined a priori.|Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests for non-parametric data||||=0.0028
74058583|NCT03722849|147669200|OTHER||||||=|0.007||||||No multiple comparisons as region of interest analysis defined a priori.|Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests for non-parametric data||||=0.0070
74058584|NCT03722849|147669201|OTHER|Group comparisons (Cough versus healthy) for each measurement using repeated measures ANOVA.|||||=|0.0019|||||||ANOVA|with repeated measures||||||=0.0019
74058585|NCT03722849|147669203|OTHER|Group-wise comparisons using unpaired t-tests or one way ANOVA|||||<|0.0001|||||||ANOVA|||||||<0.0001
74058586|NCT04888377|147669204|NON_INFERIORITY|The primary hypothesis of non-inferiority was tested by calculating the mean difference between treatment arms and its associated 90% confidence interval for the primary outcome. If the lower bound of the 90% confidence interval was greater than -4, then LDA was assumed to be non-inferior to placebo. If non-inferiority were assumed, a one-sided t-test would test the benefit of LDA compared to placebo. All models controlled for site as the original randomization stratification factor.|Mean Difference (Final Values)|-0.8||||0.25|TWO_SIDED|95.0|-2.2|0.6||For each outcome, the adjusted mean difference between treatment groups and the associated 95% confidence interval based on an ANCOVA model is presented.|ANCOVA||Mean difference is Aspirin-Placebo.|Assuming a non-inferiority margin of 4 points in the BSID-III cognitive score as clinically significant, and a true effect of LDA of not more than a 1 point decrease, a total sample size of 620 was determined to provide 80% power for a one-sided test for non-inferiority with a type I error of 5%. To test this secondary hypothesis, the sample size also provided over 90% power, at a two-sided type I error of 5%, to detect a difference of 4 points between LDA and placebo based on a two-sided test.||0.6|-2.2|0.25
74058587|NCT05279807|147669223|SUPERIORITY||Mean difference pre vs post treatment|-13.5|||<|0.001|TWO_SIDED|95.0|-14.5|-12.5|||Paired Samples T-Test|||Primary endpoint, verified on the single cohort of patients who completed the monotherapy run-in period, is calculated as the mean difference in sitting diastolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 4 (Week 8, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)||-12.5|-14.5|< 0.001
74058588|NCT05644756|147669238|OTHER|The primary analysis examined changes in measurement-based care (MBC) collection over time using ANOVA. The study was not designed as a superiority, non-inferiority, or equivalence trial.|||||>|0.01|||||||ANOVA|||||||>.01
74058589|NCT03985982|147669239|SUPERIORITY||||||<|0.001||||||This outcome measure is the first to be assessed in a hierarchical testing sequence using a one-sided alpha of 0.025.|Cochran-Mantel-Haenszel|||||||<0.001
74058590|NCT03985982|147669240|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the second test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous test shows statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4||||<0.001
74058591|NCT03985982|147669240|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the third test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous two tests show statistical significance at the alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4||||<0.001
74058592|NCT03985982|147669240|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the forth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous three tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4.||||<0.001
74058593|NCT03985982|147669240|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the fifth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous four tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4||||<0.001
74058594|NCT03985982|147669240|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the sixth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous five tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Age Appraisal VAS score||||<0.001
73881825|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.41||0.0287|TWO_SIDED|95.0|-1.69|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.09|-1.69|0.0287
74058595|NCT00617175|147669298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Negative binomial regression|||||||<0.001
74058596|NCT02203305|147669300|SUPERIORITY||||||<|0.001||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and condition (p\<0.001). Interaction: Interval and condition (p\<0.001).||Recorded 50-word consonant-nucleus-consonant (CNC) words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.||||<0.001
74058597|NCT02203305|147669300|SUPERIORITY||||||<|0.001||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and condition (p\<0.001). Interaction: interval and condition (p\<0.001).||Recorded 50-word CNC words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.||||<0.001
74058598|NCT02203305|147669300|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.||Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
74058599|NCT02203305|147669300|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
74058600|NCT02203305|147669300|SUPERIORITY||||||<|0.429||||||A logit transformation was applied to proportion correct data prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and group (p=0.429). Interaction: group and interval (p=0.387).||Comparison of word recognition between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.429
74058601|NCT02203305|147669301|SUPERIORITY||||||<|0.019||||||The Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.19) and condition (p\<0.001). Interaction: interval and condition (p\<0.019).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.019
74058602|NCT02203305|147669301|SUPERIORITY||||||<|0.012||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.012) and condition (p\<0.001). Interaction: interval and condition (p=0.004).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.012
74058603|NCT02203305|147669301|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
74058604|NCT02203305|147669301|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
74058605|NCT02203305|147669301|OTHER|correlation|bivariate pearson correlation|0.42|||=|0.033|TWO_SIDED||||||bivariate pearson correlation|||Association of age at implantation and sound source localization (RMS) at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).||||=0.033
74058606|NCT02203305|147669301|SUPERIORITY||||||<|0.249||||||There were significant main effects of group (p\<0.001) and interval (p\<0.001). There was a non-significant interaction between group and interval (p=0.249).|Mixed Models Analysis|Main effects: group (p\<0.001) and interval (p\<0.001). Interaction: group and interval (p=0.249).||Comparison of sound source localization between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.249
74058607|NCT02203305|147669302|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the Speech, Spatial, \& Qualities of hearing scale (SSQ) as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
74101333|NCT02585778|147752292|SUPERIORITY||Odds Ratio (OR)|84.6|||<|0.0001|TWO_SIDED|95.0|36.5|196.1||Threshold for significance at 0.05 level|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||196.1|36.5|<0.0001
74101334|NCT02585778|147752293|SUPERIORITY||Odds Ratio (OR)|52.9|||<|0.0001|TWO_SIDED|95.0|16.6|168.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||168.3|16.6|<0.0001
74058608|NCT02203305|147669302|SUPERIORITY||||||=|0.056||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||=0.056
74058609|NCT02203305|147669302|SUPERIORITY||||||<|0.448||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.488).||Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.448
74101335|NCT02585778|147752294|SUPERIORITY||Odds Ratio (OR)|33.2|||<|0.0001|TWO_SIDED|95.0|8.0|137.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||137.4|8.0|<0.0001
73888207|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|46.1||||0.0427|TWO_SIDED|95.0|1.5|90.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.6|1.5|0.0427
73881826|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0028|TWO_SIDED|95.0|-2.05|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.43|-2.05|0.0028
74058610|NCT02203305|147669302|SUPERIORITY||||||<|0.299||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: subscale (p\<0.001) and interval (p=0.072). Interaction: subscale and interval (p=0.299).||Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.299
74058611|NCT02203305|147669302|SUPERIORITY||||||<|0.018||||||There were significant main effects of interval (p\<0.001) and pragmatic subscale (p\<0.001), and their interaction (p\<0.018).|Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.018).||Responses on the SSQ Speech pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.018
74058612|NCT02203305|147669302|SUPERIORITY||||||<|0.767|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p=0.767). Interaction: interval and pragmatic subscale (p=0.542).||Responses on the SSQ Spatial pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.767
74058613|NCT02203305|147669302|SUPERIORITY||||||<|0.242|||||||Mixed Models Analysis|Main effects: interval (p=0.003) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.242).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.242
74101336|NCT02585778|147752294|SUPERIORITY||Odds Ratio (OR)|27.1|||<|0.0001|TWO_SIDED|95.0|14.2|51.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||51.5|14.2|<0.0001
74101337|NCT02585778|147752295|SUPERIORITY||Odds Ratio (OR)|55.5||||0.0002|TWO_SIDED|95.0|6.5|473.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||473.7|6.5|0.0002
74101338|NCT02585778|147752295|SUPERIORITY||Odds Ratio (OR)|103.3|||<|0.0001|TWO_SIDED|95.0|24.6|433.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||433.1|24.6|<0.0001
74101339|NCT02585778|147752296|SUPERIORITY||Adjusted Mean Difference|-18.7||||0.0039|TWO_SIDED|95.0|-31.4|-6.0||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-6.0|-31.4|0.0039
74101340|NCT02585778|147752296|SUPERIORITY||Adjusted Mean Difference|-18.4|||<|0.0001|TWO_SIDED|95.0|-23.7|-13.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-13.2|-23.7|<0.0001
74101341|NCT02585778|147752297|SUPERIORITY||LS Mean Difference|3.9||||0.3434|TWO_SIDED|95.0|-4.2|12.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||12.0|-4.2|0.3434
74101342|NCT02585778|147752297|SUPERIORITY||LS Mean Difference|4.4||||0.01|TWO_SIDED|95.0|1.1|7.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||7.7|1.1|0.0100
74101343|NCT02585778|147752298|SUPERIORITY||Adjusted Mean Difference|-5.7||||0.0902|TWO_SIDED|95.0|-12.3|0.9||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||0.9|-12.3|0.0902
73881827|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.42||0.0004|TWO_SIDED|95.0|-2.32|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.67|-2.32|0.0004
74058614|NCT02203305|147669302|OTHER|Bivariate pearson correlation||||||0.37|||||||bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||0.370
74101344|NCT02370238|147752312|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.589|TWO_SIDED|95.0|0.71|1.81||p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||1.81|0.71|0.589
74101345|NCT02370238|147752313|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.897|TWO_SIDED|95.0|0.64|1.65||p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||1.65|0.64|0.897
74058615|NCT02203305|147669302|OTHER|bivariate pearson correlation|||||=|0.865||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.865
74058616|NCT02203305|147669302|OTHER|bivariate pearson correlation|bivariate pearson correlation|0.6|||=|0.005|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.005
74058617|NCT02203305|147669302|OTHER|bivariate pearson correlation|bivariate pearson correlation|0.67|||=|0.006|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.006
74058618|NCT02203305|147669302|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.33|||=|0.152|TWO_SIDED||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).||||=0.152
74058619|NCT02203305|147669302|OTHER|bivariate pearson correlation|||||=|0.761|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).||||=0.761
74058620|NCT02203305|147669302|OTHER|bivariate pearson correlation|||||=|0.315|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).||||=0.315
74058621|NCT02203305|147669302|OTHER|bivariate pearson correlation|||||=|0.666|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).||||=0.666
74058622|NCT02203305|147669302|SUPERIORITY||||||>|0.175|||||||Mixed Models Analysis|Main effects: cohort (p=0.912), interval (p=0.463), and subscale (p=0.483). Interactions: 2-way or 3-way (p\>0.175).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the speech, spatial, and qualities of hearing subscales during the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.175
74058623|NCT02203305|147669303|SUPERIORITY||||||<|0.161||||||"Significant effect of interval (p=0.046) and of condition (p\<0.001) and a non-significant interaction (p=0.161).~Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis."|Mixed Models Analysis|Main effects: interval (p=0.046) and condition (p\<0.001). Interaction: interval and condition (p=0.161).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.161
74058624|NCT02203305|147669303|SUPERIORITY||||||>|0.107||||||"Significant effect of condition (p\<0.001) and the interaction (p\<0.001). Non-significant effect of interval (p=0.107).~Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis."|Mixed Models Analysis|Main effects: condition (p\<0.001) and interval p=0.107). Interaction of condition and interval (p\<0.001).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||>0.107
74058625|NCT02203305|147669303|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
74058626|NCT02203305|147669303|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
74058627|NCT02203305|147669303|OTHER|bivariate pearson correlation|||||=|0.58||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of age at implantation and speech recognition in noise at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation.||||=0.580
74058628|NCT02203305|147669303|SUPERIORITY||||||<|0.743||||||A logit transformation was applied to proportion correct data prior to analysis.|Mixed Models Analysis|Effects: SNR (p=0.026) \& masker condition (p\<0.001). Interactions: cohort \& condition (p\<0.001), interval \& condition (p=0.015). Others (p\>0.140).||Comparison of speech recognition between groups (UHL/SSD and AHL) for the three masker configurations (noise towards the better hearing ear, noise towards the poorer hearing ear, and noise from the front) and signal-to-noise ratio (SNR; 0, 5, or 10 dB SNR) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.743
74058629|NCT02203305|147669303|OTHER|pearson correlation|||||=|0.036||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||=0.036
74058630|NCT02203305|147669304|SUPERIORITY||||||<|0.183||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: interval (p=0.183) and condition (p=0.012). Interaction: interval and condition (p=0.081).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.183
73881828|NCT03192176|147297636|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.87|-1.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-1.22|-2.87|<0.0001
74058631|NCT02203305|147669304|SUPERIORITY||||||<|0.196||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: interval (p=0.010) and condition (p=0.100). Interaction: interval and condition (p=0.196).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.196
74058632|NCT02203305|147669304|SUPERIORITY|||||||0.056||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||0.056
74058633|NCT02203305|147669304|SUPERIORITY||||||=|0.21||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||=0.210
73888208|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0||||0.9318|TWO_SIDED|95.0|-66.9|73.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.0|-66.9|0.9318
74058634|NCT02203305|147669305|SUPERIORITY||||||<|0.071||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.071) and condition (p\<0.001). Interaction: interval and condition (p\<0.051)||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.071
74058635|NCT02203305|147669305|SUPERIORITY||||||<|0.109||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.109) and condition (p\<0.001). Interaction: interval and condition (p=0.052).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.109
74058636|NCT02203305|147669305|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
74101346|NCT02370238|147752314|SUPERIORITY||Odds Ratio (OR)|1.262||||0.667|TWO_SIDED|95.0|0.4909|3.963||P-value is based on Zelen's test for homogeneity of the odds ratios.|Zelen's test|||||3.963|0.4909|0.667
74101347|NCT02370238|147752316|SUPERIORITY|||||||0.767||||||For the All Patients group, p-value was based on a log-rank test stratified by actual sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||||0.767
74101348|NCT02370238|147752317|SUPERIORITY||Odds Ratio (OR)|1.101||||0.667|TWO_SIDED|95.0|0.437|2.79||P-value was based on Zelen's test for homogeneity of the odds ratios|Zelen's test|||||2.790|0.437|0.667
74101349|NCT02054338|147752370|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.54|TWO_SIDED|95.0|0.91|1.2|||Log Rank|||Kaplan-Meier curves and life tables by treatment arm to describe time-dependent parameters. Stratified Cox proportional model was used to compare the 2 treatment arms. A stratified Cox proportional hazards model and logistic regression were applied to the progression-free survival and to the tumour response, respectively.||1.20|0.91|0.54
74101350|NCT02054338|147752371|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.86|TWO_SIDED|95.0|0.87|1.19|||Log Rank|||||1.19|0.87|0.86
74101351|NCT02054338|147752372|SUPERIORITY||Hazard Ratio (HR)|11.3||||0.1|TWO_SIDED|95.0|8.7|14.4|||Log Rank|||||14.4|8.7|0.10
74101352|NCT00428116|147752387|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||WAZ-score comparison at 18 months||||0.15
74101353|NCT00428116|147752387|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||HAZ score at 18 months||||0.45
74101354|NCT00428116|147752388|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||log rank or Cox regression|incidence with Cox regression utilized Anderson-Gill method to handle recurrent events||SAEs||||0.39
74101355|NCT00428116|147752388|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Cox regression Anderson Gill|||Pneumonia||||0.60
74101356|NCT00428116|147752388|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Regression, Cox|||Pneumonia||||0.60
74101357|NCT00428116|147752388|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Regression, Cox|||Diarrhea||||0.77
74101358|NCT00428116|147752388|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||Death||||0.29
74101359|NCT01685840|147752401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.88|TWO_SIDED|95.0|0.79|1.22||A sample size of 1100 patients was expected to provide approximately 90% power to detect a difference in the primary endpoint with an assumed type I error rate of 0.05, 2-sided. Analysis was adjusted for age, sex, ejection fraction, NT-proBNP and DM.|Regression, Cox|||||1.22|0.79|0.88
74058637|NCT02203305|147669305|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
74058638|NCT02203305|147669306|SUPERIORITY||||||<|0.024||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.018) and condition (p\<0.001). Interaction: interval and condition (p=0.024).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.024
74058639|NCT02203305|147669306|SUPERIORITY||||||<|0.219|||||||Mixed Models Analysis|Main effects: interval (p=0.187) and condition (p\<0.001). Interaction: interval and condition (p=0.219).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.219
74058640|NCT02203305|147669306|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
74058641|NCT02203305|147669306|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
74058642|NCT02203305|147669307|SUPERIORITY||||||=|0.011||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the Abbreviated Profile of Hearing Aid Benefit (APHAB) as measured with the global score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||=0.011
74058643|NCT02203305|147669307|SUPERIORITY||||||=|0.264||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses were compared to responses over the post-activation period (1, 3, 6, 9, and 12 months) with the cochlear implant using a repeated-measures ANOVA.||||=0.264
74058644|NCT02203305|147669307|SUPERIORITY||||||<|0.023||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.005) and subscales (p=0.001). Interaction: interval and subscales (p=0.023).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.023
74058645|NCT02203305|147669307|SUPERIORITY||||||<|0.643|||||||Mixed Models Analysis|Main effects: interval (p=0.643) and subscale (p=0.005). Interaction: interval and subscale (p=0.480).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.643
74058646|NCT02203305|147669307|OTHER|bivariate pearson correlation (one-tailed)|||||=|0.947||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.947
74058647|NCT02203305|147669307|SUPERIORITY||||||=|0.5||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.500
73888209|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|110.4||||0.002|TWO_SIDED|95.0|41.2|179.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||179.6|41.2|0.0020
74058648|NCT02203305|147669307|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.51|||=|0.023|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.023
74058649|NCT02203305|147669307|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.55|||=|0.033|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.033
73881829|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1826|TWO_SIDED|95.0|-1.38|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||0.26|-1.38|0.1826
73881830|NCT03192176|147297636|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.41||0.0178|TWO_SIDED|95.0|-1.79|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.17|-1.79|0.0178
74058650|NCT02203305|147669307|SUPERIORITY||||||>|0.208|||||||Mixed Models Analysis|Main effects: cohort (p=0.541), interval (p=0.446), and subscale (p=0.208). Interactions: 2-way or 3-way (p\>0.287).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the ease of communication, background noise, and reverberation subscales over the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.208
73881831|NCT03192176|147297636|SUPERIORITY||LSMean differnce|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0025|TWO_SIDED|95.0|-2.06|-0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.44|-2.06|0.0025
73881832|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9163|TWO_SIDED|95.0|-0.55|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.50|-0.55|0.9163
74058651|NCT02203305|147669308|SUPERIORITY||||||=|0.221||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months)."||||=0.221
74058652|NCT02203305|147669308|SUPERIORITY||||||=|0.538||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months)."||||=0.538
74101360|NCT01685840|147752402|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.37|TWO_SIDED|95.0|0.62|1.2|||Regression, Cox|||||1.20|0.62|0.37
74101361|NCT01685840|147752403|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.0||||0.53|TWO_SIDED|95.0|-20.0|39.0|||Bang-Tsiatis Partitioned Estimator|||||39|-20|0.53
74101362|NCT01685840|147752404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.75|TWO_SIDED|95.0|0.65|1.37|||Regression, Cox|||||1.37|0.65|0.75
74101363|NCT01685840|147752405|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.76|TWO_SIDED|95.0|0.82|1.31|||Regression, Cox|||||1.31|0.82|0.76
74101364|NCT01685840|147752406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.08|TWO_SIDED|95.0|0.97|1.72|||Anderson-Gill Intensity Model|||||1.72|0.97|0.08
74101365|NCT01685840|147752407|SUPERIORITY|||||||0.636|||||||Mixed Models Analysis|||Baseline||||0.636
74101366|NCT01685840|147752407|SUPERIORITY|||||||0.628|||||||Mixed Models Analysis|||3 month||||0.628
74101367|NCT01685840|147752407|SUPERIORITY|||||||0.586|||||||Mixed Models Analysis|||6 month||||0.586
74058653|NCT02203305|147669308|SUPERIORITY||||||>|0.218||||||There were no significant main effects of cohort (p=0.265) or interval (p=0.430). There was no significant interaction between cohort and interval (p=0.218).|Mixed Models Analysis|Main effects: cohort (p=0.265) or interval (p=0.430). Interaction: cohort and interval (p=0.218).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the Tinnitus Handicap Inventory over the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.218
74058654|NCT02203305|147669309|SUPERIORITY||||||<|0.322||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effect: interval (p=0.084) and condition (p=0.322). Interaction: interval and condition (p=0.125).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.322
74058655|NCT02203305|147669309|SUPERIORITY||||||<|0.317||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effects: interval (p=0.014) and condition (p=0.317). Interaction: interval and condition (p=0.118).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.317
74101368|NCT01685840|147752407|SUPERIORITY|||||||0.669|||||||Mixed Models Analysis|||12 month||||0.669
74101369|NCT01685840|147752407|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|||24 month||||0.949
74101370|NCT01685840|147752408|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.404|TWO_SIDED|95.0|-1.188|2.947||Adjusted P-value|Mixed Models Analysis|||3 month||2.947|-1.188|0.404
74101371|NCT01685840|147752408|SUPERIORITY||Mean Difference (Final Values)|1.478||||0.219|TWO_SIDED|95.0|-0.881|3.836||Adjusted P-value|Mixed Models Analysis|||6 month||3.836|-0.881|0.219
74101372|NCT01685840|147752408|SUPERIORITY||Mean Difference (Final Values)|2.099||||0.104|TWO_SIDED|95.0|-0.433|4.63||Adjusted P-value|Mixed Models Analysis|||12 month||4.630|-0.433|0.104
74101373|NCT01685840|147752408|SUPERIORITY||Mean Difference (Final Values)|1.999||||0.228|TWO_SIDED|95.0|-1.253|5.25|||Mixed Models Analysis|||24 month||5.250|-1.253|0.228
74101374|NCT01685840|147752409|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.421|TWO_SIDED|95.0|-0.025|0.06||Adjusted P-value|Mixed Models Analysis|||3 month||0.060|-0.025|0.421
74101375|NCT01685840|147752409|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.239|TWO_SIDED|95.0|-0.018|0.074||Adjusted P-value|Mixed Models Analysis|||6 month||0.074|-0.018|0.239
74101376|NCT01685840|147752409|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.402|TWO_SIDED|95.0|-0.028|0.07|||Mixed Models Analysis|||12 month||0.070|-0.028|0.402
74101377|NCT01685840|147752409|SUPERIORITY||Mean Difference (Final Values)|0.009||||0.78|TWO_SIDED|95.0|-0.057|0.076||Adjusted P-value|Mixed Models Analysis|||24 month||0.076|-0.057|0.780
74101378|NCT01685840|147752410|SUPERIORITY||Mean Difference (Final Values)|-2.131||||0.268|TWO_SIDED|95.0|-5.902|1.64||Adjusted P-value|Mixed Models Analysis|||3 month||1.640|-5.902|0.268
74101379|NCT01685840|147752410|SUPERIORITY||Mean Difference (Final Values)|1.069||||0.599|TWO_SIDED|95.0|-2.921|5.058|||Mixed Models Analysis|||6 month||5.058|-2.921|0.599
74101380|NCT01685840|147752410|SUPERIORITY||Mean Difference (Final Values)|-0.389||||0.852|TWO_SIDED|95.0|-4.486|3.707||Adjusted P-value|Mixed Models Analysis|||12 month||3.707|-4.486|0.852
74101381|NCT01685840|147752410|SUPERIORITY||Mean Difference (Final Values)|-3.343||||0.221|TWO_SIDED|95.0|-8.708|2.022||Adjusted P-value|Mixed Models Analysis|||24 month||2.022|-8.708|0.221
74101382|NCT01685840|147752411|SUPERIORITY||Mean Difference (Final Values)|-0.816||||0.615|TWO_SIDED|95.0|-3.999|2.367||Adjusted P-value|Mixed Models Analysis|||3 month||2.367|-3.999|0.615
74101383|NCT01685840|147752411|SUPERIORITY||Mean Difference (Final Values)|0.252||||0.878|TWO_SIDED|95.0|-2.977|3.482||Adjusted P-value|Mixed Models Analysis|||6 month||3.482|-2.977|0.878
74101384|NCT01685840|147752411|SUPERIORITY||Mean Difference (Final Values)|-1.406||||0.441|TWO_SIDED|95.0|-4.989|2.178||Adjusted P-value|Mixed Models Analysis|||12 month||2.178|-4.989|0.441
73881833|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.1597|TWO_SIDED|95.0|-0.92|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.15|-0.92|0.1597
74101385|NCT01685840|147752411|SUPERIORITY||Mean Difference (Final Values)|1.091||||0.653|TWO_SIDED|95.0|-3.673|5.856||Adjusted P-value|Mixed Models Analysis|||24 month||5.856|-3.673|0.653
74101386|NCT01685840|147752412|SUPERIORITY||Mean Difference (Final Values)|-1.226||||0.199|TWO_SIDED|95.0|-3.097|0.645||Adjusted P-value|Mixed Models Analysis|||3 month||0.645|-3.097|0.199
74101387|NCT01685840|147752412|SUPERIORITY||Mean Difference (Final Values)|-0.742||||0.465|TWO_SIDED|95.0|-2.735|1.25|||Mixed Models Analysis|||6 month||1.250|-2.735|0.465
74101388|NCT01685840|147752412|SUPERIORITY||Mean Difference (Final Values)|-0.074||||0.943|TWO_SIDED|95.0|-2.119|1.97||Adjusted P-value|Mixed Models Analysis|||12 month||1.970|-2.119|0.943
74101389|NCT01685840|147752412|SUPERIORITY||Mean Difference (Final Values)|1.478||||0.294|TWO_SIDED|95.0|-1.286|4.241||Adjusted P-value|Mixed Models Analysis|||24 month||4.241|-1.286|0.294
74101390|NCT01685840|147752413|SUPERIORITY||Mean Difference (Final Values)|-1.579||||0.294|TWO_SIDED|95.0|-4.527|1.369||Adjusted P-value|Mixed Models Analysis|||3 month||1.369|-4.527|0.294
74101391|NCT01685840|147752413|SUPERIORITY||Mean Difference (Final Values)|-0.946||||0.555|TWO_SIDED|95.0|-4.096|2.203||Adjusted P-value|Mixed Models Analysis|||6 month||2.203|-4.096|0.555
74101392|NCT01685840|147752413|SUPERIORITY||Mean Difference (Final Values)|-0.798||||0.643|TWO_SIDED|95.0|-4.178|2.583||Adjusted P-value|Mixed Models Analysis|||12 month||2.583|-4.178|0.643
74101393|NCT01685840|147752413|SUPERIORITY||Mean Difference (Final Values)|-0.647||||0.757|TWO_SIDED|95.0|-4.767|3.472||Adjusted P-value|Mixed Models Analysis|||24 month||3.472|-4.767|0.757
74101394|NCT01685840|147752414|SUPERIORITY||Mean Difference (Final Values)|-0.484||||0.837|TWO_SIDED|95.0|-5.102|4.133||Adjusted P-value|Mixed Models Analysis|||3 month||4.133|-5.102|0.837
74101395|NCT01685840|147752414|SUPERIORITY||Mean Difference (Final Values)|-2.693||||0.288|TWO_SIDED|95.0|-7.662|2.276||Adjusted P-value|Mixed Models Analysis|||6 month||2.276|-7.662|0.288
74101396|NCT01685840|147752414|SUPERIORITY||Mean Difference (Final Values)|-1.539||||0.567|TWO_SIDED|95.0|-6.81|3.732||Adjusted P-value|Mixed Models Analysis|||12 month||3.732|-6.810|0.567
74101397|NCT01685840|147752414|SUPERIORITY||Mean Difference (Final Values)|2.512||||0.475|TWO_SIDED|95.0|-4.394|9.419||Adjusted P-value|Mixed Models Analysis|||24 month||9.419|-4.394|0.475
74101398|NCT01685840|147752415|SUPERIORITY||Mean Difference (Final Values)|1.057||||0.696|TWO_SIDED|95.0|-4.25|6.364||Adjusted P-value|Mixed Models Analysis|||3 month||6.364|-4.250|0.696
73888210|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|81.5||||0.0226|TWO_SIDED|95.0|11.6|151.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||151.4|11.6|0.0226
74101399|NCT01685840|147752415|SUPERIORITY||Mean Difference (Final Values)|1.966||||0.497|TWO_SIDED|95.0|-3.715|7.647||Adjusted P-value|Mixed Models Analysis|||6 months||7.647|-3.715|0.497
74101400|NCT01685840|147752415|SUPERIORITY||Mean Difference (Final Values)|6.564||||0.035|TWO_SIDED|95.0|0.456|12.673||Adjusted P-value|Mixed Models Analysis|||12 month||12.673|0.456|0.035
74101401|NCT01685840|147752415|SUPERIORITY||Mean Difference (Final Values)|2.857||||0.488|TWO_SIDED|95.0|-5.247|10.961||Adjusted P-value|Mixed Models Analysis|||24 month||10.961|-5.247|0.488
74101402|NCT01685840|147752416|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.992|TWO_SIDED|95.0|-3.383|3.417||Adjusted P-value|Mixed Models Analysis|||3 month||3.417|-3.383|0.992
74101403|NCT01685840|147752416|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.882|TWO_SIDED|95.0|-3.409|3.969||Adjusted P-value|Mixed Models Analysis|||6 month||3.969|-3.409|0.882
74101404|NCT01685840|147752416|SUPERIORITY||Mean Difference (Final Values)|0.904||||0.647|TWO_SIDED|95.0|-2.973|4.782||Adjusted P-value|Mixed Models Analysis|||12 month||4.782|-2.973|0.647
74101405|NCT01685840|147752416|SUPERIORITY||Mean Difference (Final Values)|0.322||||0.903|TWO_SIDED|95.0|-4.894|5.538||Adjusted P-value|Mixed Models Analysis|||24 month||5.538|-4.894|0.903
74101406|NCT01685840|147752417|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Hospitalizations||||0.74
74101407|NCT01685840|147752417|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||ER only events||||0.45
74101408|NCT01685840|147752417|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Rehab facilities||||0.67
74101409|NCT01685840|147752417|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Total admissions||||0.47
74101410|NCT01685840|147752418|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Hospital Costs||||0.88
74101411|NCT01685840|147752418|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Physician Fees||||0.69
74101412|NCT01685840|147752418|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Total Cost||||0.88
74101413|NCT01198132|147752457|SUPERIORITY_OR_OTHER||Rate ratio|0.8||||0.3797|TWO_SIDED|95.0|0.48|1.32|||Poisson log-linear model|||||1.32|0.48|0.3797
74101414|NCT03516513|147752508|SUPERIORITY|t-tests||||||0.905|||||||t-test, 2 sided|||||||0.905
74101415|NCT03516513|147752508|SUPERIORITY|t-test||||||0.32|||||||t-test, 2 sided|||||||.320
74101416|NCT03516513|147752509|SUPERIORITY|||||||0.155||||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.155
74101417|NCT03516513|147752509|SUPERIORITY|||||||0.974||||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.974
74101418|NCT03516513|147752511|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||||||.212
74101419|NCT03516513|147752512|SUPERIORITY|||||||0.507|||||||t-test, 2 sided|||||||.507
74101420|NCT03516513|147752513|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||.091
74101421|NCT03390426|147752521|SUPERIORITY|"this is a superiority study and the non-inferiority or equivalence analysis is not required"|||||<|0.05||||||Comparisons were made between the two groups using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables. p-value of \<0.05 was considered to be statistically significant.|t-test, 2 sided|Comparisons were made using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables.||We determined 30 subjects were needed to detect a 50% difference in THN incidence between the two groups using a one-sided Fisher's exact test with alpha = 0.05 and 80% power while allowing up to 20% drop-out. For primary and secondary outcomes, comparisons were made between the two groups using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables. p-value of \<0.05 was considered to be statistically significant.||||<0.05
74101422|NCT02924727|147752569|SUPERIORITY||Hazard Ratio (HR)|0.9012||||0.1659|TWO_SIDED|95.0|0.7778|1.0441|||Cox's Proportional Hazard Model|||Primary Composite||1.0441|0.7778|0.1659
74101423|NCT02924727|147752569|SUPERIORITY||Hazard Ratio (HR)|0.874||||0.2031|TWO_SIDED|95.0|0.7104|1.0754|||Cox's Proportional Hazard Model|||CV Death||1.0754|0.7104|0.2031
74101424|NCT02924727|147752569|SUPERIORITY||Hazard Ratio (HR)|0.8653||||0.1679|TWO_SIDED|95.0|0.7044|1.0629|||Cox's Proportional Hazard Model|||First HF Hospitalization||1.0629|0.7044|0.1679
74101425|NCT02924727|147752569|SUPERIORITY||Hazard Ratio (HR)|0.6831||||0.0667|TWO_SIDED|95.0|0.4546|1.0266|||Cox's Proportional Hazard Model|||First Outpatient HF||1.0266|0.4546|0.0667
74101426|NCT02924727|147752570|SUPERIORITY||Hazard Ratio (HR)|0.9133||||0.2507|TWO_SIDED|95.0|0.7824|1.0662|||Cox's Proportional Hazard Model|||CV death or HF hospitalization||1.0662|0.7824|0.2507
74101427|NCT02924727|147752571|SUPERIORITY||Hazard Ratio (HR)|0.8422||||0.0732|TWO_SIDED|95.0|0.6979|1.0163|||Cox's Proportional Hazard Model|||HF hospitalization or Outpatient HF||1.0163|0.6979|0.0732
74101428|NCT02924727|147752572|SUPERIORITY||Hazard Ratio (HR)|0.9007||||0.1785|TWO_SIDED|95.0|0.7734|1.0489|||Cox's Proportional Hazard Model|||CV death, Non-fatal spontaneous MI or Non-fatal stroke||1.0489|0.7734|0.1785
74101429|NCT02924727|147752573|SUPERIORITY||Rate Ratio|0.8361||||0.0452|TWO_SIDED|95.0|0.7018|0.9961|||Negative Binomial regression model|||Total Number of Confirmed Composite Endpoints||0.9961|0.7018|0.0452
74101430|NCT02924727|147752574|SUPERIORITY||Hazard Ratio (HR)|0.8751||||0.1556|TWO_SIDED|95.0|0.7279|1.052|||Cox's Proportional Hazard Model|||All-Cause Death||1.0520|0.7279|0.1556
74101431|NCT00509795|147752579|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.1|-4.4|3.1|||||The difference is calculated as ranibizumab minus IAI. A positive value favors IAI 2.0Q4. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI.||3.1|-4.4|
74101432|NCT00509795|147752579|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-1.5|||||TWO_SIDED|95.1|-5.1|2.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 0.5Q4 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).||2.1|-5.1|
74101433|NCT00509795|147752579|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.1|-4.5|3.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 2.0Q8 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).||3.1|-4.5|
74101434|NCT00509795|147752580|SUPERIORITY_OR_OTHER||Differences in Least Squares means|3.15||||0.0054|TWO_SIDED|95.1|0.92|5.37||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||5.37|0.92|0.0054
74101435|NCT00509795|147752580|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.8||||0.4793|TWO_SIDED|95.1|-3.03|1.43||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.43|-3.03|0.4793
74101436|NCT00509795|147752580|SUPERIORITY_OR_OTHER||Differences in Least Squares Means|0.26||||0.8179|TWO_SIDED|95.1|-1.97|2.49||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||2.49|-1.97|0.8179
74101437|NCT00509795|147752581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.6||||0.1042|TWO_SIDED|95.1|-1.0|14.1||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The null hypothesis is that both percentages are equal.||14.1|-1.0|0.1042
74101438|NCT00509795|147752581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.0||||0.1037|TWO_SIDED|95.1|-13.2|1.2||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The null hypothesis is that both percentages are equal.||1.2|-13.2|0.1037
74101439|NCT00509795|147752581|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.93|TWO_SIDED|95.1|-7.7|7.0||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as VEGF Trap-Eye minus ranibizumab. A positive value favors VEGF Trap-Eye 2.0Q8.|The pairwise The null hypothesis is that both percentages are equal.||7.0|-7.7|0.93
74101440|NCT00509795|147752582|SUPERIORITY_OR_OTHER||Differences Least Squares means|1.28||||0.209|TWO_SIDED|95.1|-0.73|3.28||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||3.28|-0.73|0.2090
74101441|NCT00509795|147752582|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.67||||0.5128|TWO_SIDED|95.1|-2.69|1.35||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.35|-2.69|0.5128
74101442|NCT00509795|147752582|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.6||||0.5579|TWO_SIDED|95.1|-2.61|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.42|-2.61|0.5579
74101443|NCT00509795|147752583|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.33||||0.3575|TWO_SIDED|95.1|-1.04|0.38||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||0.38|-1.04|0.3575
74101444|NCT00509795|147752583|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.71||||0.0507|TWO_SIDED|95.1|-0.01|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 0.5Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.42|-0.01|0.0507
74101445|NCT00509795|147752583|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.86||||0.0173|TWO_SIDED|95.1|0.15|1.58||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q8|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.58|0.15|0.0173
74101446|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.989|||||TWO_SIDED|95.0|0.223|4.393|||||Hazard ratio comparing PFS of participants with a high expression of EIF4EBP1 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of EIF4EBP1 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker EIF4EBP1 Cytoplasm with PFS.||4.393|0.223|
74101447|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.071|||||TWO_SIDED|95.0|0.316|3.628|||||Hazard ratio comparing PFS of participants with a high expression of EIF4E Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of EIF4E Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker EIF4E Cytoplasm with PFS.||3.628|0.316|
74058656|NCT02203305|147669309|SUPERIORITY||||||=|0.017||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.017
74058657|NCT02203305|147669309|SUPERIORITY||||||=|0.292||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.292
74058658|NCT02203305|147669309|OTHER|pearson correlation|||||>|0.185|||||||bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||>0.185
74058659|NCT02203305|147669310|SUPERIORITY||||||<|0.581||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effect: interval (p=0.039) and condition (p=0.007). Interaction: interval and condition (p=0.581).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.581
74058660|NCT02203305|147669310|SUPERIORITY||||||<|0.817||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effects: condition (p=0.005) and interval (p=0.528). Interaction: condition and interval (p=0.817).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.817
74058661|NCT02203305|147669310|SUPERIORITY||||||=|0.008||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.008
74058662|NCT02203305|147669310|SUPERIORITY||||||=|0.009|||||||ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.009
74058663|NCT02203305|147669310|OTHER|bivariate correlation|||||=|0.049||||||"Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.~This correlation was no longer significant when controlling for the hearing threshold at 8000 Hz."|bivariate pearson correlation|||Association of age at implantation and performance at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).||||=0.049
74058664|NCT02203305|147669310|OTHER|pearson correlation|||||>|0.185|||||||bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||>0.185
74058665|NCT02203305|147669311|SUPERIORITY||||||<|0.44|||||||Mixed Models Analysis|Main effects: interval (p=0.070) and condition (p=0.440). Interaction: interval and condition (p=0.047).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.440
74058666|NCT02203305|147669311|SUPERIORITY||||||<|0.379|||||||Mixed Models Analysis|Main effects: condition (p\<0.001) and interval (p=0.250). Interaction: interval and condition (p=0.379).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.379
74058667|NCT02203305|147669311|SUPERIORITY||||||=|0.021|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.021
74058668|NCT02203305|147669311|SUPERIORITY||||||<|0.001|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||<0.001
74058669|NCT02203305|147669312|SUPERIORITY||||||<|0.639||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: condition (p\<0.001) and interval (p=0.639). Interaction: interval and condition (p=0.280).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.639
74058670|NCT02203305|147669312|SUPERIORITY||||||<|0.637|||||||Mixed Models Analysis|Main effects: condition (p\<0.001) and interval (p=0.637). Interaction: interval and condition (p=0.450).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.637
73881834|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4871|TWO_SIDED|95.0|-0.74|0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.35|-0.74|0.4871
74058671|NCT02203305|147669312|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||<0.001
74058672|NCT02203305|147669312|SUPERIORITY||||||=|0.002|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.002
74101448|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.658|||||TWO_SIDED|95.0|0.454|6.053|||||Hazard ratio comparing PFS of participants with a high expression of HDAC2 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of HDAC2 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker HDAC2 Nucleus with PFS.||6.053|0.454|
74058673|NCT02203305|147669313|SUPERIORITY||||||<|0.671|||||||Mixed Models Analysis|Main effects: interval (p=0.020) and condition (p=0.406). Interaction: interval and condition (p=0.671).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.671
74058674|NCT02203305|147669313|SUPERIORITY||||||>|0.124|||||||Mixed Models Analysis|Main effects: interval (p=0.124) and condition (p=0.845). Interaction: interval and condition (p=0.960).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||>0.124
74058675|NCT02203305|147669313|SUPERIORITY||||||=|0.025|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.025
74058676|NCT02203305|147669313|SUPERIORITY||||||=|0.442|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.442
74058677|NCT02203305|147669314|SUPERIORITY||||||<|0.001||||||Percent correct values were converted to rationalized arcsine units prior to analysis.|t-test, 2 sided|||Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).||||<0.001
74058678|NCT02203305|147669314|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|t-test, 2 sided|||Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).||||<0.001
74058679|NCT02203305|147669315|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Participants listened with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.||||<0.001
74058680|NCT02203305|147669315|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Participants listening with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.||||<0.001
74058681|NCT02203305|147669315|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.||||<0.001
74058682|NCT02203305|147669315|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.||||<0.001
74058683|NCT02203305|147669316|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.||||<0.001
73881835|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5401|TWO_SIDED|95.0|-0.72|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.38|-0.72|0.5401
74058684|NCT02203305|147669316|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.||||<0.001
74058685|NCT02203305|147669316|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscales (p\<0.001). Interaction: interval and subscales (p\<0.001).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.||||<0.001
74058686|NCT02203305|147669316|SUPERIORITY||||||<|0.01||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscales (p=0.010). Interaction: interval and subscales (p=0.001).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.||||<0.010
74058687|NCT02203305|147669317|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant."||||<0.001
74058688|NCT02203305|147669317|SUPERIORITY||||||=|0.003||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant."||||=0.003
74058689|NCT02203305|147669318|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
74058690|NCT02203305|147669318|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
74058691|NCT02203305|147669318|SUPERIORITY||||||<|0.001||||||"There were significant main effects of interval (p\<0.001) and subscale (p\<0.001) and interaction (p=0.001).~A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity."|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.001).||Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.||||<0.001
74058692|NCT02203305|147669318|SUPERIORITY||||||<|0.034||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.034).||Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.||||<0.034
74058693|NCT02203305|147669318|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.001).||Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.001
74058694|NCT02203305|147669318|SUPERIORITY||||||<|0.192|||||||Mixed Models Analysis|Main effect: interval (p\<0.001) and pragmatic subscale (p=0.192). Interaction: interval and pragmatic subscale (p=0.001).||Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.192
74058695|NCT02203305|147669318|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.001).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.001
74058696|NCT02203305|147669318|SUPERIORITY||||||<|0.479|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.479).||Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.479
73881836|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.3788|TWO_SIDED|95.0|-0.3|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.79|-0.30|0.3788
73881837|NCT03192176|147297636|SUPERIORITY||0.28|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.4541|TWO_SIDED|95.0|-0.33|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.74|-0.33|0.4541
74058697|NCT02203305|147669318|SUPERIORITY||||||<|0.804|||||||Mixed Models Analysis|Main effect: interval (p\<0.001) and pragmatic subscale (p=0.804). Interaction: interval and pragmatic subscale (p=0.090).||Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.804
74058698|NCT02203305|147669318|SUPERIORITY||||||<|0.005|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.005).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.005
74058699|NCT02203305|147669319|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
74058700|NCT02203305|147669319|SUPERIORITY||||||=|0.034|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.034
74058701|NCT02203305|147669320|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
74058702|NCT02203305|147669320|SUPERIORITY||||||=|0.037|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.037
74058703|NCT02203305|147669321|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||<0.001
74058704|NCT02203305|147669321|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
74058705|NCT02203305|147669322|SUPERIORITY||||||=|0.004|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) with a bone-conduction device (preoperative interval) and 2) with the cochlear implant (CI) at the 12-month post-activation interval. Results are reported in dB SNR, where a lower value indicates better performance. A paired samples t-test compared the performance with the two devices.||||=0.004
74058706|NCT02203305|147669322|SUPERIORITY||||||=|0.004|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.004
74058707|NCT02203305|147669323|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||<0.001
74058708|NCT02203305|147669323|SUPERIORITY||||||=|0.727|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.727
74058709|NCT02203305|147669324|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.001
74058710|NCT02203305|147669324|SUPERIORITY||||||=|0.09|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.090
74101449|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|4.082|||||TWO_SIDED|95.0|0.455|36.628|||||Hazard ratio comparing PFS of participants with a high expression of PCREB Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PCREB Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PCREB Nucleus with PFS.||36.628|0.455|
74101450|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.636|||||TWO_SIDED|95.0|0.18|2.253|||||Hazard ratio comparing PFS of participants with a high expression of PEIF3746 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIF3746 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIF3746 Cytoplasm with PFS.||2.253|0.180|
74101451|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.362|||||TWO_SIDED|95.0|0.083|1.576|||||Hazard ratio comparing PFS of participants with a high expression of PEIF3746 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIF3746 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIF3746 Nucleus with PFS.||1.576|0.083|
74101452|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.522|||||TWO_SIDED|95.0|0.473|4.901|||||Hazard ratio comparing PFS of participants with a high expression of PEIFS209 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFS209 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFS209 Cytoplasm with PFS.||4.901|0.473|
74101453|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.908|||||TWO_SIDED|95.0|0.223|3.699|||||Hazard ratio comparing PFS of participants with a high expression of PEIFS65 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFS65 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFS65 Nucleus with PFS.||3.699|0.223|
74101454|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.843|||||TWO_SIDED|95.0|0.432|7.867|||||Hazard ratio comparing PFS of participants with a high expression of PEIFT70 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFT70 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFT70 Nucleus with PFS.||7.867|0.432|
74101455|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.926|||||TWO_SIDED|95.0|0.276|3.109|||||Hazard ratio comparing PFS of participants with a high expression of P GSK3B Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of P GSK3B Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker P GSK3B Cytoplasm with PFS.||3.109|0.276|
74101456|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.985|||||TWO_SIDED|95.0|0.32|3.033|||||Hazard ratio comparing PFS of participants with a high expression of PKCb2 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PKCb2 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PKCb2 Cytoplasm with PFS.||3.033|0.320|
74101457|NCT00451178|147752613|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.817|||||TWO_SIDED|95.0|0.242|2.758|||||Hazard ratio comparing PFS of participants with a high expression of PTEN Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PTEN Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PTEN Cytoplasm with PFS.||2.758|0.242|
74101458|NCT04324073|147752721|SUPERIORITY||Median posterior absolute risk differenc|0.2|||||TWO_SIDED|90.0|-11.7|12.2||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credibility interval here|||12.2|-11.7|
74101459|NCT04324073|147752722|SUPERIORITY||Median posterior Hazard Ratio|1.1|||||TWO_SIDED|90.0|0.69|1.74||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible interval here|||1.74|0.69|
74101460|NCT04324073|147752723|SUPERIORITY||Median posterior absolute risk differenc|-7.3|||||TWO_SIDED|90.0|-22.5|8.7||Posterior probability|Bayesian analysis|Adjusted on age and centre|% Confidence Interval is %Credible Interval here. Results are presented as the proportion not improved, so that an effective treatment would be associated with a decrease in proportion.|||8.7|-22.5|
74101461|NCT04324073|147752724|SUPERIORITY||Median posterior Hazard Ratio|1.05|||||TWO_SIDED|90.0|0.55|2.07||Posterior probability|Bayesian analysis||% Confidence Interval is % Credible Interval here|||2.07|0.55|
74101462|NCT04324073|147752725|SUPERIORITY|Day 14|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.23|2.03|||Regression, Cox|adjusted for age and sex||||2.03|0.23|
74101463|NCT04324073|147752725|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.27|1.59|||Regression, Cox|||Day 28||1.59|0.27|
74101464|NCT04324073|147752725|SUPERIORITY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.31|1.58|||Regression, Cox|||Day 90||1.58|0.31|
74101465|NCT04324073|147752725|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.4|2.25|||Regression, Cox|||Day 14||2.25|0.40|
74101466|NCT04324073|147752725|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.4|1.96|||Regression, Cox|||Day 28||1.96|0.40|
74101467|NCT04324073|147752725|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.35|1.58|||Regression, Cox|||Day 90||1.58|0.35|
74101468|NCT04324073|147752726|SUPERIORITY||Median posterior OR|1.11|||||TWO_SIDED|95.0|0.53|2.34|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 4||2.34|0.53|
74101469|NCT04324073|147752726|SUPERIORITY||Median posterior OR|1.02|||||TWO_SIDED|95.0|0.49|2.08|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 7||2.08|0.49|
74101470|NCT04324073|147752726|SUPERIORITY||Median posterior OR|0.79|||||TWO_SIDED|95.0|0.42|1.47|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 14||1.47|0.42|
73881838|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9233|TWO_SIDED|95.0|-0.51|0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.56|-0.51|0.9233
74101471|NCT04324073|147752726|SUPERIORITY||Median posterior OR|0.88|||||TWO_SIDED|95.0|0.38|2.02|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 4||2.02|0.38|
74101472|NCT04324073|147752726|SUPERIORITY||Median posterior OR|1.07|||||TWO_SIDED|95.0|0.47|2.4|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 14||2.40|0.47|
74101473|NCT04324073|147752726|SUPERIORITY||Median posterior OR|1.13|||||TWO_SIDED|95.0|0.5|2.57|||Proportionnal odds model|Bayesian analysis. Adjusted for age and sex|% Confidence Interval is % Credible Interval here|Day 90||2.57|0.50|
74101474|NCT04324073|147752727|SUPERIORITY||Median Difference (Net)|-1.5|||||TWO_SIDED|95.0|-6.1|3.9||||adjusted on age and centre||||3.9|-6.1|
74101475|NCT04324073|147752728|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.72|1.57|||Fine-Gray model|adjusted for age and centre||Day 28||1.57|0.72|
74101476|NCT04324073|147752728|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.74|2.25|||Fine-Gray model|Adjusted for age and centre||Day 90||2.25|0.74|
74101477|NCT04324073|147752728|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.59|2.44|||Fine-Gray model|adjusted for age and centre||Day 28||2.44|0.59|
74101478|NCT04324073|147752728|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.74|1.55|||Fine-Gray model|Adjusted for age and centre||Day 90||1.55|0.74|
74101479|NCT04324073|147752729|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.81|1.75|||Fine-Gray model|Adjusted on age and centre||Day 28||1.75|0.81|
74101480|NCT04324073|147752729|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.8|1.67|||Fine-Gray model|Adjusted on age and centre||Day 90||1.67|0.80|
74101481|NCT04324073|147752729|SUPERIORITY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.55|2.66|||Fine-Gray model|Adjusted on age and centre||Day 28||2.66|0.55|
74101482|NCT04324073|147752729|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.71|2.37|||Fine-Gray model|Adjusted on age and centre||Day 90||2.37|0.71|
74101483|NCT04324073|147752730|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.42|1.44|||Fine-Gray model|Adjusted for age and centre||Day 28||1.44|0.42|
73881839|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6043|TWO_SIDED|95.0|-0.61|0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.35|-0.61|0.6043
74101484|NCT04324073|147752730|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.49|1.47|||Fine-Gray model|adjusted for age and centre||Day 90||1.47|0.49|
74101485|NCT01277601|147752753|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank|||||||< 0.001
74101486|NCT01277601|147752753|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank|||||||0.002
74101487|NCT04034927|147752769|SUPERIORITY||Odds Ratio (OR)|0.707|||||TWO_SIDED|95.0|0.241|2.068|||||The numerator is the experimental arm (odds of response) and the denominator is the control arm (odds of response).|Odds ratio for experimental arm (O + T) response compared to control arm (O) response.||2.068|0.241|
74101488|NCT03996447|147752772|SUPERIORITY||Mean Difference (Final Values)|1.82|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|1.76|1.88||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||1.88|1.76|<.0001
74101489|NCT03996447|147752772|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.81|2.0||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.00|1.81|<.0001
74101490|NCT03996447|147752772|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.29|1.44||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||1.44|1.29|<.0001
73881840|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1781|TWO_SIDED|95.0|-0.82|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.15|-0.82|0.1781
74101491|NCT03996447|147752772|SUPERIORITY||Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|2.2|2.33||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.33|2.20|<.0001
74101492|NCT03996447|147752772|SUPERIORITY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.69|1.85||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||1.85|1.69|<.0001
74101493|NCT03996447|147752772|SUPERIORITY||Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.85|2.06||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.06|1.85|<.0001
74058711|NCT02203305|147669330|SUPERIORITY||||||<|0.923|||||||Mixed Models Analysis|Main effect: electrode (p\<0.001), target stimulus (p=0.923), and interval (p=0.226). Interaction: electrode and interval (p=0.496).||A linear mixed effects model compared the main effects of target stimulus (click, tone), electrode (1-5), and interval (1, 3, 6, and 12 months) on the normalized pitch match.||||<0.923
74058712|NCT02203305|147669330|OTHER||||||>|0.164|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and word recognition with the CI alone.||||>0.164
74058713|NCT02203305|147669330|OTHER|bivariate pearson correlation|||||>|0.367|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and speech recognition in noise (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear).||||>0.367
74058714|NCT02203305|147669330|OTHER|bivariate pearson correlation|||||>|0.349|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and sound source localization (RMS error).||||>0.349
74058715|NCT02203305|147669331|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||"Comparison of the unaided threshold at 125 Hz at the preoperative and initial activation intervals for the 25 participants with unaided threshold of 80 dB HL or better at the preoperative interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array."||||<0.001
74058716|NCT02203305|147669331|SUPERIORITY||||||=|0.47|||||||ANOVA|generalized linear mixed-effects model||"Comparison of the unaided threshold at 125 Hz from the initial activation to the 12-month post-activation interval for the 9 participants with an unaided threshold of 95 dB HL or better at the initial activation interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array."||||=0.47
73881841|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5221|TWO_SIDED|95.0|-0.66|0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.34|-0.66|0.5221
74058717|NCT02203305|147669332|SUPERIORITY||||||=|0.739|||||||t-test, 2 sided|||A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.||||=0.739
74058718|NCT02203305|147669332|SUPERIORITY||||||=|0.553|||||||t-test, 2 sided|||A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.||||=0.553
74058719|NCT02203305|147669333|SUPERIORITY||||||<|0.345||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|Main effect: interval (p=0.027) and masker condition (p\<0.001). Interaction: interval and masker condition (p=0.345).||A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.||||<0.345
74058720|NCT02203305|147669333|SUPERIORITY||||||<|0.577||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|Main effect: masker condition (p\<0.001) and interval (p=0.577). Interaction: interval and masker condition (p=0.055).||A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.||||<0.577
73888211|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|32.0||||0.3629|TWO_SIDED|95.0|-37.3|101.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||101.2|-37.3|0.3629
74058721|NCT02203305|147669334|SUPERIORITY||||||>|0.023|||||||Mixed Models Analysis|Main effect: coding strategy (p=0.023). Interaction: coding strategy and electrode (p=0.044). All other main effects and interactions were p\>0.160.||A linear mixed effect model assessed the main effects of stimulus, electrode, and coding strategy, and their interactions.||||>0.023
74058722|NCT02203305|147669334|SUPERIORITY||||||>|0.035|||||||t-test, 2 sided|Pitch perception for electrode 1 (p=0.035). All other comparisons were p\>0.318.||Paired samples t-tests evaluated whether pitch perception (mean normalized pitch) differed between coding strategy for each electrode.||||>0.035
74058723|NCT02203305|147669335|SUPERIORITY||||||>|0.084|||||||ANOVA|Main effects: condition (p=0.960) and interval (p=0.084). Interaction: condition and interval (p=0.433).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.||||>0.084
74058724|NCT02203305|147669335|SUPERIORITY||||||>|0.434|||||||ANOVA|Main effect: condition (p=0.434) or interval (p=0.687). Interaction: condition and interval (p=0.678).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.||||>0.434
74058725|NCT02203305|147669336|SUPERIORITY||||||<|0.935||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|ANOVA|Main effects: condition (p=0.018), interval (p=0.012), and masker (p\<0.001). Interactions: interval and masker (p\<0.001). Other interactions: p\>0.117.||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.||||<0.935
74101494|NCT03996447|147752772|SUPERIORITY||Mean Difference (Final Values)|2.77|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|2.69|2.85||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.85|2.69|<.0001
74101495|NCT03996447|147752772|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|2.49|2.67||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement - Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.67|2.49|<.0001
74101496|NCT03996447|147752772|SUPERIORITY||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|2.84|2.95||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.95|2.84|<.0001
74101497|NCT03996447|147752773|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.06|0.02||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.02|-0.06|<0.0001
74101498|NCT03996447|147752773|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.04|0.11||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.11|-0.04|<0.0001
74101499|NCT03996447|147752773|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.01|0.05|||t-test, 2 sided|||Criterion: Border delineation; Reader 3||0.05|-0.01|<0.0001
74101500|NCT03996447|147752773|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.04|0.03|||t-test, 2 sided|||Criterion: Internal morphology; Reader 1||0.03|-0.04|<0.0001
74101501|NCT03996447|147752773|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.05|0.09|||t-test, 2 sided|||Criterion: Internal morphology; Reader 2||0.09|-0.05|<0.0001
74101502|NCT03996447|147752773|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.01|0.08|||t-test, 2 sided|||Criterion: Internal morphology; Reader 3||0.08|0.01|<0.0001
74101503|NCT03996447|147752773|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.0001|TWO_SIDED|95.0|-0.04|0.07|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1||0.07|-0.04|0.0001
74101504|NCT03996447|147752773|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.03|0.12|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 2||0.12|-0.03|<0.0001
74101505|NCT03996447|147752773|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.03|0.15|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3||0.15|0.03|<0.0001
74101506|NCT02291510|147752774|SUPERIORITY_OR_OTHER||% Ratio of LS Means|35.4|||<|0.001|TWO_SIDED|90.0|32.27|38.74|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.||38.74|32.27|<0.001
74101507|NCT02291510|147752774|SUPERIORITY_OR_OTHER||% Ratio of LS Means|52.3|||<|0.001|TWO_SIDED|90.0|47.77|57.36|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||57.36|47.77|<0.001
74058726|NCT02203305|147669336|SUPERIORITY||||||<|0.977||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|Effects: interval (p=0.012) and masker (p\<0.001). Interactions: interval\&masker (p=0.020) \& condition, interval, \&masker (p=0.035). Others: (p\>0.131).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.||||<0.977
74058727|NCT03586427|147669337|OTHER|Mixed model of repeated measures least square estimates of change compared to placebo|||||>|0.05||||||Comparison of each dose level change from baseline to placebo baseline yielded P values \>0.05|Mixed Models Analysis|||Each dose group was compared to placebo||||>0.05
74058728|NCT00423137|147669350|OTHER||Difference of least square means|-1.385|STANDARD_ERROR_OF_MEAN|2.181||0.5305|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.||||||0.5305
74058729|NCT00423137|147669351|OTHER||Difference of least square means|-0.049|STANDARD_ERROR_OF_MEAN|0.033||0.1498|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.1498
74058730|NCT00423137|147669354|OTHER||Difference of least square means|0.335|STANDARD_ERROR_OF_MEAN|0.434||0.4472|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.4472
74058731|NCT00423137|147669355|OTHER||Difference of least square means|-0.141|STANDARD_ERROR_OF_MEAN|0.342||0.6829|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.6829
74058732|NCT00423137|147669356|OTHER||Difference of least square means|0.571|STANDARD_ERROR_OF_MEAN|0.391||0.1565|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.1565
74058733|NCT00423137|147669357|OTHER||Difference of least square means|1.081|STANDARD_ERROR_OF_MEAN|1.185||0.3709|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.3709
74058734|NCT00423137|147669358|OTHER||Difference of least square means|-52.083|STANDARD_ERROR_OF_MEAN|16.48||0.0044|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0044
74058735|NCT00423137|147669359|OTHER||Difference of least square means|-67.012|STANDARD_ERROR_OF_MEAN|21.29||0.0056|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0056
74058736|NCT00423137|147669360|OTHER||Difference of least square means|-62.571|STANDARD_ERROR_OF_MEAN|18.42||0.0025|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0025
74058737|NCT00423137|147669361|OTHER||Difference of least square means|-40.067|STANDARD_ERROR_OF_MEAN|18.8||0.0439|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0439
74058738|NCT00423137|147669362|OTHER||Difference of least square means|-57.46|STANDARD_ERROR_OF_MEAN|21.3||0.0129|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0129
74058739|NCT00423137|147669363|OTHER||Difference of least square means|-55.332|STANDARD_ERROR_OF_MEAN|17.11||0.0037|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0037
74058740|NCT00423137|147669364|OTHER||Difference of least square means|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.9076|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.9076
74058741|NCT00423137|147669365|OTHER||Difference of least square means|-13453.0|STANDARD_ERROR_OF_MEAN|16118.0||0.4121|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.4121
74058742|NCT00423137|147669366|OTHER||Difference of least square means|-78.619|STANDARD_ERROR_OF_MEAN|298.91||0.7948|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.7948
74058743|NCT00423137|147669367|OTHER||Difference of least square means|0.195|STANDARD_ERROR_OF_MEAN|0.101||0.064|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.0640
74058744|NCT00423137|147669368|OTHER||Difference of least square means|0.007|STANDARD_ERROR_OF_MEAN|0.004||0.0587|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.0587
74058745|NCT03478982|147669369|SUPERIORITY||Difference in percentage|23.3|||=|0.0392|TWO_SIDED|95.0|1.8|44.8|||Chi-squared|||||44.8|1.8|=0.0392
74058746|NCT03478982|147669369|SUPERIORITY||Difference in percentage|23.3|||=|0.0392|TWO_SIDED|95.0|1.8|44.8|||Chi-squared|||||44.8|1.8|=0.0392
74058747|NCT00593385|147669373|OTHER||Meta-Analysis|9.67||||0.005|ONE_SIDED|95.0||16.57||An exact one sided upper 95% confidence interval of the primary endpoint rate was calculated based on primary analysis population.|Exact test of the binomial distribution||To estimate primary endpoint rate, a meta-analysis was performed on data from 3 previous studies. The meta-analytical rate derived was 9.67%|The composite event rate to determine the performance metric of 16.57% was based on a meta-analysis performed on data from 3 previous studies(9.67%). A 6.9% margin was deemed acceptable at the time of study design. Rejection of the null hypothesis requires that the iCAST Covered Stent primary endpoint rate was significantly below 16.57%. Other assumptions for the analysis included a power of 80% and one-sided alpha error of 5%.||16.57||0.005
74058748|NCT00924313|147669412|SUPERIORITY||||||<|0.0001||||||The reported p-value is representative of the difference in levels of the histopathologic confirmed tumor and normal prostate tissue.|Spearman rank correlation|||||||<0.0001
74058749|NCT00924313|147669412|SUPERIORITY|||||||0.65||||||The reported p-value is representative of the BPH high uptake level.|Spearman rank correlation|||||||0.65
74058750|NCT00924313|147669415|SUPERIORITY|||||||0.55|||||||Spearman rank correlation|||||||0.55
74058751|NCT00924313|147669417|SUPERIORITY|||||||0.407|||||||Spearman rank correlation|||||||0.407
74058752|NCT04983589|147669486|SUPERIORITY||Percentage Difference|27.3|||<|0.0001|TWO_SIDED|95.0|17.3|37.4||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation based on pooled variance without continuity correction.|||37.4|17.3|<0.0001
74058753|NCT04983589|147669487|SUPERIORITY||Percentage Difference|26.4|||<|0.0001|TWO_SIDED|95.0|16.8|36.0||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation based on pooled variance without continuity correction.|||36.0|16.8|<0.0001
74058754|NCT04983589|147669488|SUPERIORITY||Percentage Difference|34.7|||<|0.0001|TWO_SIDED|95.0|22.7|46.7||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated based on the normal approximation using pooled variance without continuity correction.|||46.7|22.7|<0.0001
74058755|NCT04983589|147669489|SUPERIORITY||Percentage Difference|20.6||||0.001|TWO_SIDED|95.0|8.6|32.6||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation using pooled variance without continuity correction.|||32.6|8.6|0.001
74058756|NCT04259905|147669490|SUPERIORITY||Cohen's d|0.85|||||TWO_SIDED|||||||||||||
74058757|NCT04259905|147669491|SUPERIORITY||Cohen's d|1.29|||||TWO_SIDED|||||||||||||
74101508|NCT02291510|147752774|SUPERIORITY_OR_OTHER||% Ratio of LS Means|32.1|||<|0.001|TWO_SIDED|90.0|29.3|35.18|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||35.18|29.30|<0.001
74101509|NCT02291510|147752774|SUPERIORITY_OR_OTHER||% Ratio of LS Means|47.5|||<|0.001|TWO_SIDED|90.0|43.38|52.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||52.09|43.38|<0.001
74101510|NCT02291510|147752774|SUPERIORITY_OR_OTHER||% Ratio of LS Means|110.1||||0.0832|TWO_SIDED|90.0|100.5|120.68|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||120.68|100.50|0.0832
74101511|NCT02291510|147752775|SUPERIORITY_OR_OTHER||% Ratio of LS Means|35.9|||<|0.001|TWO_SIDED|90.0|32.43|39.77|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||39.77|32.43|<0.001
74058758|NCT04259905|147669492|SUPERIORITY||Cohen's d|1.06|||||TWO_SIDED|||||||||||||
74058759|NCT00762073|147669513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.239||||0.5282|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.5282
74058760|NCT00762073|147669513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.86||||0.0092|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.0092
74058761|NCT00762073|147669513|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.009||||0.0174|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.0174
74058762|NCT00762073|147669514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1786|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.1786
74058763|NCT00762073|147669514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0090
74058764|NCT00762073|147669514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0001
74058765|NCT00762073|147669515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4959|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.4959
74058766|NCT00762073|147669515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0040
74058767|NCT00762073|147669515|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||<0.0001
74058768|NCT00762073|147669516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0108|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.0108
74058769|NCT00762073|147669516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0208|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.0208
74058770|NCT00762073|147669516|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||<0.0001
74058771|NCT00762073|147669517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1095|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.1095
74058772|NCT00762073|147669517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0264|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.0264
73881842|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.4744|TWO_SIDED|95.0|-0.68|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.32|-0.68|0.4744
74058773|NCT00762073|147669517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.0010
74058774|NCT00762073|147669518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3769|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3769
74058775|NCT00762073|147669518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9363|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.9363
74058776|NCT00762073|147669518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1235|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.1235
74058777|NCT00762073|147669519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3444|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3444
74058778|NCT00762073|147669519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9258|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.9258
74058779|NCT00762073|147669519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3215|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3215
74058780|NCT00762073|147669520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6729|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.6729
74058781|NCT00762073|147669520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8894|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.8894
74058782|NCT00762073|147669520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1532|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.1532
74058783|NCT00762073|147669521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4197|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.4197
74058784|NCT00762073|147669521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9787|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.9787
74058785|NCT00762073|147669521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8987|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.8987
74058786|NCT00491322|147669529|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
74058787|NCT02279888|147669540|OTHER|the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80%|Kaplan Meier|0.05|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73881843|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5167|TWO_SIDED|95.0|-0.66|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.33|-0.66|0.5167
74058788|NCT02279888|147669542|OTHER||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.39|0.47|||Andersen-Gill||This analysis applies to Primary Outcome: HFH Rate|||0.47|0.39|<0.0001
74058789|NCT02279888|147669544|OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.52|0.62|||Andersen-Gill|||||0.62|0.52|<0.0001
74058790|NCT00602667|147669573|OTHER||Hazard Ratio (HR)|4.99|||||TWO_SIDED|95.0|1.17|21.23||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).||21.23|1.17|
74058791|NCT00602667|147669573|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.4|1.84||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).||1.84|0.40|
74058792|NCT00602667|147669574|OTHER||Hazard Ratio (HR)|1.85|||||TWO_SIDED|95.0|0.42|8.22||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).||8.22|0.42|
74058793|NCT00602667|147669574|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.31|1.79||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).||1.79|0.31|
74058794|NCT03315780|147669652|SUPERIORITY||Mean Difference (Final Values)|-254.02|||<|0.0001|TWO_SIDED|95.0|-337.76|-170.28|||Mixed Models Analysis|||||-170.28|-337.76|< 0.0001
74058795|NCT03315780|147669655|SUPERIORITY||Mean Difference (Final Values)|27.46||||0.01|TWO_SIDED|95.0|8.05|46.87|||Mixed Models Analysis|||||46.87|8.05|0.0100
74058796|NCT03315780|147669656|SUPERIORITY||Mean Difference (Final Values)|3.72||||0.0263|TWO_SIDED|95.0|0.63|6.81|||Mixed Models Analysis|||||6.81|0.63|0.0263
74058797|NCT03315780|147669657|SUPERIORITY||Mean Difference (Final Values)|-9.36||||0.08|TWO_SIDED|95.0|-20.16|1.43|||Mixed Models Analysis|||||1.43|-20.16|0.0800
74058798|NCT03315780|147669658|SUPERIORITY||Mean Difference (Final Values)|-15.39||||0.7475|TWO_SIDED|95.0|-118.35|87.57|||Mixed Models Analysis|||||87.57|-118.35|0.7475
74058799|NCT01361308|147669660|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA|||||||<0.0001
74058800|NCT01361308|147669660|SUPERIORITY_OR_OTHER|||||||0.009||||||Week 12 frequency|Rank transformed ANCOVA|||||||0.0090
74058801|NCT01361308|147669661|SUPERIORITY_OR_OTHER|||||||0.001||||||Clinical meaningfulness at week 4|Logit model|||||||0.001
74058802|NCT01361308|147669661|SUPERIORITY_OR_OTHER|||||||0.055||||||Clinical meaningfulness at week 12|Logit model|||||||0.055
74058803|NCT01361308|147669677|SUPERIORITY_OR_OTHER|||||||0.0017||||||Week 4 severity|Rank transformed ANCOVA|||||||0.0017
74058804|NCT01361308|147669677|SUPERIORITY_OR_OTHER|||||||0.1658||||||Week 12 severity|Rank transformed ANCOVA|||||||0.1658
74058805|NCT02060526|147669682|SUPERIORITY_OR_OTHER_LEGACY||Difference between proportions|0.286||||0.4615|TWO_SIDED|95.0|-0.297|0.745|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.||0.745|-0.297|0.4615
74058806|NCT02060526|147669682|SUPERIORITY_OR_OTHER_LEGACY||Difference between proportions|0.143||||1|TWO_SIDED|95.0|-0.423|0.647|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.||0.647|-0.423|1.0000
74058807|NCT02074982|147669717|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|2.01|4.02|||Regression, Logistic|||||4.02|2.01|<0.0001
74058808|NCT01335620|147669731|SUPERIORITY|||||||0.018|||||||Regression, Logistic|||Compare baseline to 24 weeks||||0.018
74058809|NCT02951182|147669733|SUPERIORITY||Least Squares (LS) Mean Difference|8.6||||0.0016|TWO_SIDED|95.0|3.5|13.8|||Mixed-effects Model for Repeated Measure|||||13.8|3.5|0.0016
74058810|NCT02951182|147669733|SUPERIORITY||Least Squares (LS) Mean Difference|10.6||||0.0001|TWO_SIDED|95.0|5.5|15.8|||Mixed-effects Model for Repeated Measure|||||15.8|5.5|0.0001
74058811|NCT02951182|147669733|SUPERIORITY||Least Squares (LS) Mean Difference|12.0||||0.0001|TWO_SIDED|95.0|6.7|17.4|||Mixed-effects Model for Repeated Measure|||||17.4|6.7|0.0001
74058812|NCT02951182|147669734|SUPERIORITY||Least Squares (LS) Mean Difference|-22.3|||||TWO_SIDED|95.0|-32.1|-12.4||||||||-12.4|-32.1|
74058813|NCT02951182|147669734|SUPERIORITY||Least Squares (LS) Mean Difference|-34.7|||||TWO_SIDED|95.0|-44.7|-24.8||||||||-24.8|-44.7|
74058814|NCT02951182|147669734|SUPERIORITY||Least Squares (LS) Mean Difference|-33.4|||||TWO_SIDED|95.0|-48.5|-18.3||||||||-18.3|-48.5|
74058815|NCT02951182|147669735|SUPERIORITY||Least Squares (LS) Mean Difference|14.8|||||TWO_SIDED|95.0|5.3|24.2||||||||24.2|5.3|
74058816|NCT02951182|147669735|SUPERIORITY||Least Squares (LS) Mean Difference|19.1|||||TWO_SIDED|95.0|9.7|28.6||||||||28.6|9.7|
74058817|NCT02951182|147669735|SUPERIORITY||Least Squares (LS) Mean Difference|20.0|||||TWO_SIDED|95.0|10.8|29.1||||||||29.1|10.8|
74058818|NCT02951182|147669736|SUPERIORITY||Least Squares (LS) Mean Difference|16.1|||||TWO_SIDED|95.0|5.4|26.8||||||||26.8|5.4|
74058819|NCT02951182|147669736|SUPERIORITY||Least Squares (LS) Mean Difference|18.5|||||TWO_SIDED|95.0|7.9|29.1||||||||29.1|7.9|
74058820|NCT02951182|147669736|SUPERIORITY||Least Squares (LS) Mean Difference|20.2|||||TWO_SIDED|95.0|11.9|28.4||||||||28.4|11.9|
74058821|NCT01828164|147669746|SUPERIORITY_OR_OTHER||Percent Change|29.0||||0.0164|TWO_SIDED||||||t-test, 1 sided||Percent change in tooth movement rate on the treatment side as compared to the control side.|||||0.0164
74058822|NCT01828164|147669747|SUPERIORITY_OR_OTHER||Percent change|220.8||||0.0423|TWO_SIDED||||||t-test, 1 sided||Percent change in root resorption rate on the control side as compared to the treatment side.|||||0.0423
74058823|NCT01828164|147669748|NON_INFERIORITY|1 point on the 10-point pain scale was used as the non-inferiority margin.|||||<|0.001|||||||Bootstrapped mean difference|This test bootstrapped the mean difference (Treatment Arm - Control Arm) less 1, the non-inferiority margin, 1000 times.||||||<0.001
74058824|NCT00761969|147669754|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||Survival, major-event-free survival and event-free survival of patients with PAD and control subjects was estimated by the Kaplan-Meier method and compared by the log-rank test. The numbers of non-fatal events and revascularization procedures (which could be more than one per person) were compared using the Poisson regression - the outcome being the number of events per person-year.||||<0.001
74058825|NCT01353586|147669757|SUPERIORITY_OR_OTHER||Proportion of events|71.6|||||TWO_SIDED|95.0|63.3|79.8|||||The above supplemental analysis is to estimate the rate of subjects without documented symptomatic AF at Day 240 using the Kaplan-Meier time-to-event analysis method to accommodate the censored information from the two withdrawn subjects.|||79.8|63.3|
74058826|NCT00585468|147669764|SUPERIORITY_OR_OTHER|||||||0.0163|||||||t-test, 2 sided|||||||0.0163
74058827|NCT00585468|147669765|SUPERIORITY_OR_OTHER|||||||0.039|||||||t-test, 2 sided|||||||0.039
74058828|NCT00585468|147669767|SUPERIORITY_OR_OTHER|||||||0.146|||||||t-test, 2 sided|||||||0.146
74058829|NCT00585468|147669768|SUPERIORITY_OR_OTHER|||||||0.4937|||||||t-test, 2 sided|||||||0.4937
74058830|NCT00585468|147669769|SUPERIORITY_OR_OTHER|||||||0.9669|||||||t-test, 2 sided|||||||0.9669
74058831|NCT00585468|147669771|SUPERIORITY_OR_OTHER|||||||0.9607|||||||t-test, 2 sided|||||||0.9607
74058832|NCT00978120|147669773|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
74058833|NCT00978120|147669774|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
74058834|NCT00978120|147669777|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||||||0.470
74058835|NCT00978120|147669778|SUPERIORITY_OR_OTHER|||||||0.12|||||||Fisher Exact|||||||0.120
74058836|NCT00978120|147669779|SUPERIORITY_OR_OTHER|||||||0.284|||||||Fisher Exact|||||||0.284
74058837|NCT00978120|147669780|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
74058838|NCT00978120|147669781|SUPERIORITY_OR_OTHER|||||||0.341|||||||Fisher Exact|||||||0.341
74058839|NCT00978120|147669782|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.020
74058840|NCT00978120|147669783|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||||||0.245
74058841|NCT00978120|147669784|SUPERIORITY_OR_OTHER|||||||0.173|||||||Fisher Exact|||||||0.173
74058842|NCT00978120|147669785|SUPERIORITY_OR_OTHER|||||||0.362|||||||Fisher Exact|||||||0.362
74058843|NCT00978120|147669786|SUPERIORITY_OR_OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
74058844|NCT00978120|147669787|SUPERIORITY_OR_OTHER|||||||0.016|||||||Fisher Exact|||||||0.016
74058845|NCT00978120|147669788|SUPERIORITY_OR_OTHER|||||||0.032|||||||Fisher Exact|||||||0.032
73881844|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3441|TWO_SIDED|95.0|-0.25|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.72|-0.25|0.3441
73881845|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5362|TWO_SIDED|95.0|-0.64|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.33|-0.64|0.5362
73881846|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9349|TWO_SIDED|95.0|-0.78|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.71|-0.78|0.9349
73881847|NCT03192176|147297636|SUPERIORITY||LSMean differencce|-1.0|STANDARD_ERROR_OF_MEAN|0.39||0.0084|TWO_SIDED|95.0|-1.78|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||-0.26|-1.78|0.0084
73881848|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.1212|TWO_SIDED|95.0|-1.38|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.16|-1.38|0.1212
74101512|NCT02291510|147752775|SUPERIORITY_OR_OTHER||% Ratio of LS Means|53.0|||<|0.001|TWO_SIDED|90.0|47.88|58.71|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||58.71|47.88|<0.001
74101513|NCT02291510|147752775|SUPERIORITY_OR_OTHER||% Ratio of LS Means|45.3|||<|0.001|TWO_SIDED|90.0|40.88|50.13|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||50.13|40.88|<0.001
74101514|NCT02291510|147752775|SUPERIORITY_OR_OTHER||% Ratio of LS Means|66.8|||<|0.001|TWO_SIDED|90.0|60.34|74.0|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||74.00|60.34|<0.001
74101515|NCT02291510|147752775|SUPERIORITY_OR_OTHER||% Ratio of LS Means|79.3||||0.0004|TWO_SIDED|90.0|71.65|87.86|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||87.86|71.65|0.0004
74101516|NCT01009814|147752821|OTHER||Mean Difference (Net)|-0.1089|STANDARD_ERROR_OF_MEAN|0.212||0.6102|TWO_SIDED|90.0|-0.4656|0.2477|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2477|-0.4656|0.6102
74101517|NCT01009814|147752821|OTHER||Mean Difference (Net)|-0.1266|STANDARD_ERROR_OF_MEAN|0.2076||0.5452|TWO_SIDED|90.0|-0.4758|0.2225|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2225|-0.4758|0.5452
74101518|NCT01009814|147752821|OTHER||Mean Difference (Net)|-0.1682|STANDARD_ERROR_OF_MEAN|0.2055||0.4178|TWO_SIDED|90.0|-0.5139|0.1775|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.1775|-0.5139|0.4178
74101519|NCT01009814|147752821|OTHER||Mean Difference (Net)|-0.4885|STANDARD_ERROR_OF_MEAN|0.2075||0.0233|TWO_SIDED|90.0|-0.8375|-0.1395|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.1395|-0.8375|0.0233
74101520|NCT01009814|147752821|OTHER||Mean Difference (Net)|-0.0177|STANDARD_ERROR_OF_MEAN|0.2043||0.9314|TWO_SIDED|90.0|-0.3613|0.3259|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.3259|-0.3613|0.9314
74101521|NCT01009814|147752821|OTHER||Mean Difference (Net)|-0.0592|STANDARD_ERROR_OF_MEAN|0.2045||0.7734|TWO_SIDED|90.0|-0.4032|0.2847|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2847|-0.4032|0.7734
74101522|NCT01009814|147752821|OTHER||Mean Difference (Net)|-0.3796|STANDARD_ERROR_OF_MEAN|0.2043||0.0702|TWO_SIDED|90.0|-0.7232|-0.036|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.0360|-0.7232|0.0702
74101523|NCT01009814|147752821|OTHER||Mean Difference (Net)|-0.0415|STANDARD_ERROR_OF_MEAN|0.1993||0.8359|TWO_SIDED|90.0|-0.3768|0.2937|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2937|-0.3768|0.8359
74101524|NCT01009814|147752821|OTHER||Mean Difference (Net)|-0.3619|STANDARD_ERROR_OF_MEAN|0.1988||0.0759|TWO_SIDED|90.0|-0.6962|-0.0275|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.0275|-0.6962|0.0759
74101525|NCT01009814|147752821|OTHER||Mean Difference (Net)|-0.3203|STANDARD_ERROR_OF_MEAN|0.1993||0.1155|TWO_SIDED|90.0|-0.6555|0.0149|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.0149|-0.6555|0.1155
74101526|NCT00451204|147752869|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.077|TWO_SIDED|95.0|0.37|1.05|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 mo, time since dx, previous glatiramer acetate tx, and previous interferon beta tx.||||1.05|0.37|0.077
74101527|NCT00451204|147752870|SUPERIORITY_OR_OTHER||Rate ratio|0.65||||0.098|TWO_SIDED|95.0|0.39|1.08|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.08|0.39|0.098
74101528|NCT00451204|147752871|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.096|TWO_SIDED|95.0|0.36|1.09|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.09|0.36|0.096
74101529|NCT00451204|147752872|SUPERIORITY_OR_OTHER||Rate ratio|0.7||||0.179|TWO_SIDED|95.0|0.42|1.17|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.17|0.42|0.179
74101530|NCT00451204|147752873|SUPERIORITY_OR_OTHER||Rate ratio|0.49||||0.016|TWO_SIDED|95.0|0.28|0.88|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||0.88|0.28|0.016
74101531|NCT00451204|147752874|SUPERIORITY_OR_OTHER||Rate ratio|0.52||||0.012|TWO_SIDED|95.0|0.31|0.86|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||0.86|0.31|0.012
74101532|NCT02794870|147752892|OTHER||% vaccine recipients with solicited AEs|60.0|||||TWO_SIDED|90.0|39.0|78.0||||||||78|39|
74101533|NCT02794870|147752892|OTHER||% placebo recipients with solicited AEs|27.0|||||TWO_SIDED|90.0|8.0|56.0||||||||56|8|
74101534|NCT02794870|147752893|OTHER||% vaccinees with unsolicited AEs|35.0|||||TWO_SIDED|90.0|18.0|56.0||||||||56|18|
74101535|NCT02794870|147752893|OTHER||% placebo with unsolicited AEs|18.0|||||TWO_SIDED|90.0|3.0|47.0||||||||47|3|
74101536|NCT02794870|147752898|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
74058846|NCT01068418|147669797|SUPERIORITY_OR_OTHER||||||<|0.05||||||Threshold for significance was P\<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the mean arterial pressure (mean of five measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.||||<0.05
74058847|NCT01068418|147669798|SUPERIORITY_OR_OTHER||||||<|0.01||||||threshold for significance was P\<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the renal plasma flow (mean of three measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.||||<0.01
74058848|NCT03155269|147669799|OTHER||Mean Difference (Final Values)|-0.0423||||0.1324|TWO_SIDED|97.5|-0.1057|0.0211||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.|||0.0211|-0.1057|0.1324
74058849|NCT03155269|147669800|OTHER||Mean Difference (Final Values)|0.229||||0.0469|TWO_SIDED|97.5|-0.03|0.489||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.|||0.489|-0.030|0.0469
74058850|NCT00943826|147669818|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.55|0.74||Stratified by Region and Recursive partitioning analysis (RPA) Class|Log Rank||Stratified by Region and RPA Class.|||0.74|0.55|<0.0001
74058851|NCT00943826|147669819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0987|TWO_SIDED|95.0|0.76|1.02|||Log Rank|Stratified by Region and RPA Class|Stratified by Region and RPA Class.|||1.02|0.76|0.0987
74058852|NCT00943826|147669820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.53|0.71||Stratified by Region and RPA Class.|Log Rank||Stratified by Region and RPA Class.|||0.71|0.53|<0.0001
74058853|NCT00326625|147669825|SUPERIORITY||Slope difference|-0.06|STANDARD_ERROR_OF_MEAN|0.083||0.4807|TWO_SIDED|95.0|-0.22|0.1|||ANCOVA||Glatiramer acetate vs. Placebo|Analysis compares the ALSFRS-R slopes of change from baseline between treatment groups. Analysis includes the following covariates: time from randomization, treatment group, time by treatment interaction, center, Riluzole use, age, site of ALS onset, time from ALS onset and baseline ALSFRS-R score.||0.10|-0.22|0.4807
74058854|NCT00326625|147669826|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8583|TWO_SIDED|95.0|0.56|2.005|||Regression, Cox||Glatiramer acetate vs. Placebo|Analysis covariates are center, riluzole use, site of ALS onset, time from ALS onset, baseline ALSFRS-R score, baseline slow vital capacity (VC) and baseline body mass index (BMI).||2.005|0.560|0.8583
74058855|NCT00517868|147669827|NON_INFERIORITY|A paired student t comparison was used to assess treatment differences as measured by 11 point numerical rating scale.|Mean Difference (Final Values)|-21.14||||0.0363|TWO_SIDED|95.0|-44.43|2.16|||t-test, 1 sided|||||2.16|-44.43|0.0363
74058856|NCT02234427|147669833|SUPERIORITY_OR_OTHER||||||<|5e-06||||||Above noted p-value is adjusted for multiple comparisons. Analysis was performed using the TopHat/Cufflinks pipeline. The differential expression algorithm uses a beta distribution and the overdispersion with a negative binomial distribution.|negative binomial|||Null Hypothesis: There is no difference in gene expression before and after aspirin therapy||||<0.000005
74058857|NCT01265875|147669834|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to day 4.||||.25
74058858|NCT01265875|147669834|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to day 7.||||.19
74058859|NCT01265875|147669834|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 30.||||.27
74058860|NCT01265875|147669836|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 4.||||.52
74058861|NCT01265875|147669836|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 30.||||.34
74058862|NCT00650806|147669883|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.031|TWO_SIDED|95.0|-1.6|-0.1|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.1|-1.6|0.031
74058863|NCT00650806|147669883|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-0.8|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.8|-2.4|<0.001
74058864|NCT00650806|147669883|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.1|-0.6|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.6|-2.1|<0.001
74058865|NCT00650806|147669884|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.4||0.045|TWO_SIDED|95.0|-1.58|-0.02|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.02|-1.58|0.045
74058866|NCT00650806|147669884|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.4|-0.8|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.80|-2.40|<0.001
74058867|NCT00650806|147669884|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.07|-0.51|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.51|-2.07|0.001
74058868|NCT00650806|147669885|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.031|TWO_SIDED|95.0|-0.59|-0.03|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.03|-0.59|0.031
74101537|NCT02794870|147752899|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank|||||||<0.001
74101538|NCT02652611|147752903|SUPERIORITY||Odds Ratio (OR)|0.3|||=|0.57|TWO_SIDED|95.0|-0.8|1.4|||t-test, 2 sided|||We reported the average pain and function from 6 to 24 months postinjury with 95% confidence intervals (CIs) and summarized pain and function at 6, 9, 12, 18, and 24 months postinjury with means and standard deviations and medians with interquartile ranges.||1.4|-0.8|=0.57
73881849|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39||0.7709|TWO_SIDED|95.0|-0.89|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.66|-0.89|0.7709
74058869|NCT00650806|147669885|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.9|-0.32|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.32|-0.90|<0.001
74058870|NCT00650806|147669885|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.76|-0.2|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.20|-0.76|<0.001
74058871|NCT00650806|147669886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.317||95.0|0.6|5.6||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||5.6|0.6|0.317
73881850|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1667|TWO_SIDED|95.0|-1.33|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.23|-1.33|0.1667
74058872|NCT00650806|147669886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.059|TWO_SIDED|95.0|0.9|11.1||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||11.1|0.9|0.059
74058873|NCT00650806|147669886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.1||||0.027|TWO_SIDED|95.0|1.0|10.0||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||10.0|1.0|0.027
74058874|NCT00650806|147669887|SUPERIORITY_OR_OTHER|||||||0.117|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.117
74058875|NCT00650806|147669887|SUPERIORITY_OR_OTHER|||||||0.225|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.225
74058876|NCT00650806|147669887|SUPERIORITY_OR_OTHER|||||||0.317|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.317
74058877|NCT00650806|147669888|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.23||0.835|TWO_SIDED|95.0|-2.68|2.17|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||2.17|-2.68|0.835
74058878|NCT00650806|147669888|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|1.29||0.466|TWO_SIDED|95.0|-3.47|1.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.59|-3.47|0.466
74058879|NCT00650806|147669888|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|1.25||0.273|TWO_SIDED|95.0|-3.87|1.09|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.09|-3.87|0.273
74058880|NCT00650806|147669889|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|1.13||0.149|TWO_SIDED|95.0|-3.85|0.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.59|-3.85|0.149
74058881|NCT00650806|147669889|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|1.18||0.541|TWO_SIDED|95.0|-3.05|1.6|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.6|-3.05|0.541
74058882|NCT00650806|147669889|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.78|STANDARD_ERROR_OF_MEAN|1.15||0.121|TWO_SIDED|95.0|-4.03|0.47|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.47|-4.03|0.121
74058883|NCT00650806|147669890|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0091||0.239|TWO_SIDED|95.0|-0.0071|0.0286|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0286|-0.0071|0.239
74058884|NCT00650806|147669890|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.0095||0.9|TWO_SIDED|95.0|-0.0174|0.0198|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0198|-0.0174|0.900
74058885|NCT00650806|147669890|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.0092||0.822|TWO_SIDED|95.0|-0.016|0.0202|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0202|-0.0160|0.822
74058886|NCT04456998|147669891|SUPERIORITY||Mean Difference (Net)|-96.1||||0.031|TWO_SIDED|95.0|-183.5|-8.8|||ANCOVA||GB002 vs. Placebo|||-8.8|-183.5|0.0310
74058887|NCT04456998|147669892|SUPERIORITY||Mean Difference (Net)|6.5||||0.5972|TWO_SIDED|95.0|-17.9|30.9|||Mixed Models Analysis||GB002 vs. Placebo|||30.9|-17.9|0.5972
74058888|NCT00965562|147669911|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Chi-squared|||||||0.15
74058889|NCT00965562|147669912|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
74058890|NCT00965562|147669913|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
74058891|NCT00965562|147669914|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Chi-squared|||||||0.09
74058892|NCT00965562|147669915|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Chi-squared|||||||0.005
74058893|NCT00965562|147669916|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||0.04
74058894|NCT00965562|147669917|SUPERIORITY_OR_OTHER||Slope|-2.63||||0.07|TWO_SIDED|95.0|-5.51|0.24|||Mixed Models Analysis||Slope represents average change in fluoxetine group IDS score as compared to placebo|||0.24|-5.51|0.07
74058895|NCT00965562|147669917|SUPERIORITY_OR_OTHER||Slope|-0.1||||0.94|TWO_SIDED|95.0|-2.85|2.65|||Mixed Models Analysis||Slope represents average change in calcium group IDS scores as compared to placebo|||2.65|-2.85|0.94
74058896|NCT00965562|147669917|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.15||||0.07|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.07
74058897|NCT00965562|147669917|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.1||||0.94|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.94
74058898|NCT00965562|147669918|SUPERIORITY_OR_OTHER||Slope|-1.63||||0.1|TWO_SIDED|95.0|-3.6|0.34|||Mixed Models Analysis||Slope represents average change in fluoxetine group PMTS scores as compared to placebo|||0.34|-3.60|0.10
74058899|NCT00965562|147669918|SUPERIORITY_OR_OTHER||Slope|-0.81||||0.4|TWO_SIDED|95.0|-2.71|1.09|||Mixed Models Analysis||Slope represents average change in calcium group PMTS scores as compared to placebo|||1.09|-2.71|0.40
74058900|NCT00965562|147669918|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.06||||0.1|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.10
74058901|NCT00965562|147669918|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.37||||0.4|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.40
74058902|NCT00965562|147669919|SUPERIORITY_OR_OTHER||Slope|-0.35||||0.07|TWO_SIDED|95.0|-0.73|0.03|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI-S scores as compared to placebo|||0.03|-0.73|0.07
74058903|NCT00965562|147669919|SUPERIORITY_OR_OTHER||Slope|-0.17||||0.36|TWO_SIDED|95.0|-0.54|0.2|||Mixed Models Analysis||Slope represents average change in calcium group CGI-S scores as compared to placebo|||0.20|-0.54|0.36
74058904|NCT00965562|147669919|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.92||||0.07|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.07
74058905|NCT00965562|147669919|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.44||||0.36|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.36
74058906|NCT00965562|147669920|SUPERIORITY_OR_OTHER||Slope|-0.28||||0.02|TWO_SIDED|95.0|-0.53|-0.04|||Mixed Models Analysis||Slope represents average change in fluoxetine group DRSP scores as compared to placebo|||-0.04|-0.53|0.02
74058907|NCT00965562|147669920|SUPERIORITY_OR_OTHER||Slope|0.06||||0.58|TWO_SIDED|95.0|-0.16|0.28|||Mixed Models Analysis||Slope represents average change in calcium group DRSP scores as compared to placebo|||0.28|-0.16|0.58
74058908|NCT00965562|147669920|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.08||||0.02|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.02
74058909|NCT00965562|147669920|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.18||||0.58|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.58
74058910|NCT00965562|147669921|SUPERIORITY_OR_OTHER||Slope|-1.03||||0.04|TWO_SIDED|95.0|-1.7|-0.35|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI Improvement scores as compared to placebo|||-0.35|-1.70|0.04
74058911|NCT00965562|147669921|SUPERIORITY_OR_OTHER||Slope|-0.2||||0.54|TWO_SIDED|95.0|-0.86|0.46|||Mixed Models Analysis||Slope represents average change in calcium group CGI Improvement scores as compared to placebo|||0.46|-0.86|0.54
74058912|NCT00965562|147669921|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.8||||0.04|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5|||||0.04
74058913|NCT00965562|147669921|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.32||||0.54|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5|||||0.54
74058914|NCT03179462|147669938|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74058915|NCT00526227|147669978|OTHER|An exact one-sided 97% upper confidence bound or a p-value will be calculated based on the observed percentage of subjects with an USADE within the first month post-implant. This rate will be considered acceptable if the one-sided 97% upper confidence bound is less than 10% or, equivalently, if the p-value is less than 0.0304.|Percentage|7.7|||||ONE_SIDED|97.0|||||||The CI was calculated based on 44 patients at interim analysis: 0 USADE were reported within 1-month post implant, ie 0% of subjects experienced a USADE. The one-sided 97% exact binomial upper confidence bound was 7.7% which is lower than 10%.|"H 0 (null hypothesis): P ≥ 10%; H A (alternative hypothesis): P \< 10%, where P is the percentage of subjects experiencing a USADE through the 1-month post implant.~An upper limit of the confidence interval of the percentage subjects with USADE not greater than or equal to 10% at the 1-month follow-up visit provides a reasonably-sized clinical study with sufficient power to detect USADEs."||||
74058916|NCT06212544|147669983|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
74058917|NCT04074109|147669985|OTHER|This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.||||||||||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||
74058918|NCT04074109|147669985|OTHER|||||||||||||||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used. We report percentages and frequencies to show feasibility|This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||
74058919|NCT01656850|147670000|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
73881851|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9213|TWO_SIDED|95.0|-0.72|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.79|-0.72|0.9213
74058920|NCT01656850|147670001|SUPERIORITY_OR_OTHER|||||||0.2786|TWO_SIDED||||||Mixed Models Analysis|||||||0.2786
74101539|NCT02652611|147752904|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.21|TWO_SIDED|95.0|-2.9|12.3|||t-test, 2 sided|||||12.3|-2.9|0.21
74101540|NCT02237092|147752907|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74101541|NCT02237092|147752908|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74101542|NCT02237092|147752909|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||t-test, 2 sided|||||||<0.02
74101543|NCT02237092|147752910|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.58|||<|0.05|TWO_SIDED|95.0|1.05|2.58|||NNT|||||2.58|1.05|<0.05
74101544|NCT00794339|147752916|EQUIVALENCE|equivalence margin=0||||||0.4883|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups by whether their T/M Ratio fell at or above vs. below the observed median of 7.3 and the the median survival was compared between the 2 groups.||||0.4883
74101545|NCT00794339|147752917|EQUIVALENCE|no equivalence margin|Slope|-0.1235|STANDARD_ERROR_OF_MEAN|1.6988||0.1924|TWO_SIDED||||||Regression, Logistic|||Logistic Regression Modeling Complete Metabolic Response by T/M Ratio||||0.1924
74101546|NCT00794339|147752918|EQUIVALENCE|equivalence margin = 0||||||0.309|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups: those at or above the median for T/M Ratio (7.3) vs. those below, and the time to primary tumor recurrence was compared between the 2 goups.||||0.3090
74101547|NCT00794339|147752919|EQUIVALENCE|equivalence margin=0||||||0.5291|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake ratio as a Predictor of PELVIC Lymph Node Metastases at Baseline||||0.5291
74101548|NCT00794339|147752919|EQUIVALENCE|equivalence margin=0||||||0.9684|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake Ratio as a Predictor of COMMON ILIAC Lymph Node Metastases at Baseline||||0.9684
74101549|NCT00794339|147752919|EQUIVALENCE|equivalence margin=0||||||0.7327|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake Ratio as a Predictor of Para Aortic Lymph Node Metastases at Baseline||||0.7327
74101550|NCT00794339|147752929|EQUIVALENCE|equivalence margin=0||||||0.4981|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups by whether their T/M Ratio fell at or above vs. below the observed median of 7.3 and the time to observe new distant metastases was compared between the groups||||.4981
74101551|NCT02075515|147752982|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\]|Adjusted GMC Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.09|||ANCOVA|||||1.09|0.86|
74101552|NCT02075515|147752982|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\]|Adjustd GMC Ratio|0.96|||||TWO_SIDED|95.0|0.85|1.08|||ANCOVA|||||1.08|0.85|
73888212|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|35.9||||0.3077|TWO_SIDED|95.0|-33.4|105.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||105.1|-33.4|0.3077
74058921|NCT01656850|147670002|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||0.420
74058922|NCT01656850|147670003|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
74058923|NCT01656850|147670004|SUPERIORITY_OR_OTHER|||||||0.2412|TWO_SIDED||||||Mixed Models Analysis|||||||0.2412
74058924|NCT01656850|147670005|SUPERIORITY_OR_OTHER|||||||0.3837|TWO_SIDED||||||Mixed Models Analysis|||||||0.3837
74058925|NCT01656850|147670006|SUPERIORITY_OR_OTHER|||||||0.9784|TWO_SIDED||||||Mixed Models Analysis|||||||0.9784
74058926|NCT01656850|147670007|SUPERIORITY_OR_OTHER|||||||0.5868|TWO_SIDED||||||Mixed Models Analysis|||||||0.5868
74058927|NCT01656850|147670008|SUPERIORITY_OR_OTHER|||||||0.1101|TWO_SIDED||||||Mixed Models Analysis|||||||0.1101
74058928|NCT01656850|147670009|SUPERIORITY_OR_OTHER|||||||0.7823|TWO_SIDED||||||Mixed Models Analysis|||||||0.7823
74058929|NCT01656850|147670010|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||Mixed Models Analysis|||||||0.5570
74058930|NCT01656850|147670011|SUPERIORITY_OR_OTHER|||||||0.6263|TWO_SIDED||||||Mixed Models Analysis|||||||0.6263
74058931|NCT01656850|147670012|SUPERIORITY_OR_OTHER|||||||0.8328|TWO_SIDED||||||Mixed Models Analysis|||||||0.8328
74101553|NCT02075515|147752982|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\].|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.88|1.1|||ANCOVA|||||1.10|0.88|
74101554|NCT01297985|147752992|SUPERIORITY||MIXREG Estimate|1.55|STANDARD_ERROR_OF_MEAN|0.62||0.013|TWO_SIDED||||||Mixed Effects Random Regression|||"This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime; and that intervention participants would report greater increases in hopefulness than controls, also maintained longitudinally~This first model reports on Recovery over time."||||.013
74101555|NCT01297985|147752993|SUPERIORITY||MIXREG Estimate|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this first model included depressive symptoms as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes depressive symptoms as the moderator (High depressive symptoms X time X study condition)"||||0.01
74058932|NCT01656850|147670013|SUPERIORITY_OR_OTHER|||||||0.7758|TWO_SIDED||||||Mixed Models Analysis|||||||0.7758
74058933|NCT01656850|147670014|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED||||||Mixed Models Analysis|||||||0.0476
74058934|NCT01656850|147670015|SUPERIORITY_OR_OTHER|||||||0.1205|TWO_SIDED||||||Mixed Models Analysis|||||||0.1205
74058935|NCT01656850|147670016|SUPERIORITY_OR_OTHER|||||||0.1512|TWO_SIDED||||||Mixed Models Analysis|||||||0.1512
74058936|NCT01656850|147670017|SUPERIORITY_OR_OTHER|||||||0.7364|TWO_SIDED||||||Mixed Models Analysis|||||||0.7364
74058937|NCT01656850|147670018|SUPERIORITY_OR_OTHER|||||||0.1995|TWO_SIDED||||||Mixed Models Analysis|||||||0.1995
74058938|NCT01656850|147670019|SUPERIORITY_OR_OTHER|||||||0.8528|TWO_SIDED||||||Mixed Models Analysis|||||||0.8528
74058939|NCT00795210|147670020|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Kruskal-Wallis|||Kruskal-Wallis Test for overall difference between groups||||0.01
74058940|NCT00795210|147670021|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||ANOVA|||||||0.42
74058941|NCT00296192|147670023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|2.91||||95.0|-2.9|8.7|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||8.7|-2.9|
74058942|NCT00296192|147670023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|2.93||||95.0|-5.7|6.0|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||6.0|-5.7|
74058943|NCT00296192|147670023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|2.86||||95.0|-2.8|8.6|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||8.6|-2.8|
74058944|NCT00296192|147670023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|3.02||||95.0|-7.4|4.6|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||4.6|-7.4|
74058945|NCT00296192|147670024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6|STANDARD_ERROR_OF_MEAN|8.58||||95.0|-25.7|8.5|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||8.5|-25.7|
74058946|NCT00296192|147670024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.8|STANDARD_ERROR_OF_MEAN|8.63||||95.0|-34.0|0.4|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||0.4|-34.0|
74058947|NCT00296192|147670024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|8.45||||95.0|-18.2|15.4|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||15.4|-18.2|
74058948|NCT00296192|147670024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.5|STANDARD_ERROR_OF_MEAN|8.9||||95.0|-23.3|12.2|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||12.2|-23.3|
74058949|NCT00296192|147670025|SUPERIORITY_OR_OTHER||Difference in proportions|-20.6||||||95.0|-53.3|12.1|||Confidence interval|||95% confidence interval in difference in success rate||12.1|-53.3|
74058950|NCT00296192|147670025|SUPERIORITY_OR_OTHER||Difference in proportions|4.4||||||95.0|-25.9|34.7|||95% confidence interval|||95% confidence interval in difference in success rate||34.7|-25.9|
74058951|NCT00296192|147670025|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||||95.0|-30.6|30.6|||95% confidence interval|||95% confidence interval in difference in success rate||30.6|-30.6|
74058952|NCT00296192|147670025|SUPERIORITY_OR_OTHER||Difference in proportions|4.4||||||95.0|-25.9|34.7|||95% confidence interval|||95% confidence interval in difference in success rate||34.7|-25.9|
74058953|NCT04633434|147670033|EQUIVALENCE|Test of whether the pretest and posttest scores are significantly different from zero.|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.56||0.69|TWO_SIDED||||||t-test, 2 sided||Estimation parameter based on paired t-test.|||||.690
74058954|NCT04633434|147670034|EQUIVALENCE|Test of whether pretest to posttest score change is greater than zero.|Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.308||0.052|TWO_SIDED||||||t-test, 2 sided|||||||.052
74058955|NCT04633434|147670035|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.41||0.135|TWO_SIDED||||||t-test, 2 sided|||||||.135
74058956|NCT04633434|147670036|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|4.24|STANDARD_ERROR_OF_MEAN|7.14||0.026|TWO_SIDED||||||t-test, 2 sided|||||||.026
74058957|NCT04633434|147670037|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
74058958|NCT04633434|147670038|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
74058959|NCT04633434|147670039|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|0.54||0.057|TWO_SIDED||||||t-test, 2 sided|||||||.057
74058960|NCT04633434|147670040|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
74058961|NCT04633434|147670041|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.1||0.352|TWO_SIDED||||||t-test, 2 sided|||||||.352
74058962|NCT04633434|147670042|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.13||0.104|TWO_SIDED||||||t-test, 2 sided|||||||.104
74058963|NCT04633434|147670045|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.106|TWO_SIDED||||||t-test, 2 sided|||||||.106
74058964|NCT04633434|147670046|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED||||||t-test, 2 sided|||||||.005
74058965|NCT04633434|147670047|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|1.9||0.082|TWO_SIDED||||||t-test, 2 sided|||||||.082
73881852|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.2315|TWO_SIDED|95.0|-1.21|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.29|-1.21|0.2315
73888213|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|39.1||||0.2662|TWO_SIDED|95.0|-30.1|108.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||108.4|-30.1|0.2662
74058966|NCT00659945|147670063|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||The primary endpoint was the incidence of emesis at any time within the first 48 hours after surgery. Power analysis showed that a sample size of 69 patients per group was necessary to detect a significant decrease in the incidence of emesis from 33% in the placebo group to 15% in the aprepitant group using a Chi-square test with an alpha value of 0.05 and power of 80%.||||<0.05
74058967|NCT00627094|147670075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0438|TWO_SIDED|95.0|1.02|2.96||In order to obtain 90% power to show superiority of Biatain Ibu compared to Biatain, a sample size of 60 pts per group (assuming a 15% drop-out rate) was found by simulating data from multi-nomial distributions over time.|Chi-squared|Result based on ITT population (evening). PP-analysis show a strong tendency (not significant) in favour of Biatain Ibu supporting the ITT-analysis||The null hypothesis to be tested was that the distributions of categorical responses were the same.||2.96|1.02|0.0438
74058968|NCT01040624|147670079|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|One-sided binomial test of univariate probability distributions||||||<0.0001
74058969|NCT03056456|147670088|SUPERIORITY||Ratio of Geometric LS Means|1.0|||||TWO_SIDED|90.0|0.81|1.23||||||Day 1||1.23|0.810|
74058970|NCT03056456|147670088|SUPERIORITY||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.817|1.25||||||Day 3||1.25|0.817|
74058971|NCT03056456|147670089|SUPERIORITY||Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|0.808|1.31||||||Day 1||1.31|0.808|
74058972|NCT03056456|147670089|SUPERIORITY|Day 3|Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.82|1.32||||||||1.32|0.820|
74058973|NCT04637815|147670098|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables|||||||TWO_SIDED|0.0||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
74058974|NCT04637815|147670099|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
74058975|NCT04637815|147670100|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
74058976|NCT04637815|147670101|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
74058977|NCT04637815|147670102|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
74058978|NCT00877799|147670105|SUPERIORITY_OR_OTHER|||||||0.057|||||||t-test, 2 sided|||||||0.057
74058979|NCT00877799|147670106|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74058980|NCT00877799|147670107|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
74058981|NCT03707145|147670168|SUPERIORITY||Partial Eta Squared|0.058|||||TWO_SIDED|||||||||Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.||||
74058982|NCT03707145|147670169|SUPERIORITY||Partial Eta Squared|0.008|||||TWO_SIDED|||||||||Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.||||
74058983|NCT05014672|147670175|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.86||||0.0206|TWO_SIDED|95.0|0.746|0.994|||Mixed Model Repeated Measures|||||0.994|0.746|0.0206
74058984|NCT05014672|147670175|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.81||||0.0057|TWO_SIDED|95.0|0.703|0.939|||Mixed Model Repeated Measures|||||0.939|0.703|0.0057
74058985|NCT05014672|147670176|SUPERIORITY||LS mean difference vs placebo|-2.16||||0.2214|TWO_SIDED|95.0|-7.785|3.458|||Mixed Model Repeated Measures|||||3.458|-7.785|0.2214
74058986|NCT05014672|147670176|SUPERIORITY||LS mean difference vs placebo|0.63||||0.591|TWO_SIDED|95.0|-4.859|6.12|||Mixed Model Repeated Measures|||||6.120|-4.859|0.5910
74058987|NCT05014672|147670179|SUPERIORITY||LS mean difference vs placebo|0.42||||0.5675|TWO_SIDED|95.0|-4.454|5.285|||Mixed Model Repeated Measures|||||5.285|-4.454|0.5675
74058988|NCT05014672|147670179|SUPERIORITY||LS mean difference vs placebo|0.02||||0.5032|TWO_SIDED|95.0|-4.886|4.926|||Mixed Model Repeated Measures|||||4.926|-4.886|0.5032
74058989|NCT05014672|147670180|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.85||||0.0491|TWO_SIDED|95.0|0.692|1.033|||Mixed Model Repeated Measures|||||1.033|0.692|0.0491
74058990|NCT05014672|147670180|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.95||||0.3099|TWO_SIDED|95.0|0.783|1.158|||Mixed Model Repeated Measures|||||1.158|0.783|0.3099
74058991|NCT05014672|147670186|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.84||||0.0039|TWO_SIDED|95.0|0.743|0.954|||Mixed Model Repeated Measures|||||0.954|0.743|0.0039
74058992|NCT05014672|147670187|SUPERIORITY||LS mean difference vs placebo|0.3905||||0.3905|TWO_SIDED|95.0|-5.496|4.153|||Mixed Model Repeated Measures|||||4.153|-5.496|0.3905
74058993|NCT05014672|147670188|SUPERIORITY||LS mean difference vs placebo|0.21||||0.5393|TWO_SIDED|95.0|-3.968|4.381|||Mixed Model Repeated Measures|||||4.381|-3.968|0.5393
74058994|NCT05014672|147670189|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.9||||0.1079|TWO_SIDED|95.0|0.759|1.065|||Mixed Model Repeated Measures|||||1.065|0.759|0.1079
74058995|NCT04636437|147670210|SUPERIORITY||Mean Difference (Net)|1.36||||0.23|TWO_SIDED|97.5|-1.2|3.92||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 48.||3.92|-1.20|0.23
74058996|NCT04636437|147670210|SUPERIORITY||Mean Difference (Net)|-0.89||||0.41|TWO_SIDED|97.5|-3.34|1.57||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 48.||1.57|-3.34|0.41
74058997|NCT04636437|147670211|SUPERIORITY||Mean Difference (Net)|0.83||||0.31|TWO_SIDED|97.5|-0.99|2.64||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 24.||2.64|-0.99|0.31
74058998|NCT04636437|147670211|SUPERIORITY||Mean Difference (Net)|-1.99||||0.012|TWO_SIDED|97.5|-3.76|-0.21||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 24.||-0.21|-3.76|0.012
74058999|NCT04636437|147670212|SUPERIORITY||Mean Difference (Net)|1.72||||0.2|TWO_SIDED|97.5|-1.33|4.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 48.||4.77|-1.33|0.20
74059000|NCT04636437|147670212|SUPERIORITY||Mean Difference (Net)|-1.49||||0.25|TWO_SIDED|97.5|-4.43|1.44||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 48.||1.44|-4.43|0.25
74059001|NCT04636437|147670213|SUPERIORITY||Mean Difference (Net)|-0.16||||0.9|TWO_SIDED|97.5|-3.23|2.9||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 24.||2.90|-3.23|0.90
74059002|NCT04636437|147670213|SUPERIORITY||Mean Difference (Net)|-1.48||||0.26|TWO_SIDED|97.5|-4.47|1.51||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 24.||1.51|-4.47|0.26
74059003|NCT04636437|147670214|SUPERIORITY||Mean Difference (Net)|1.19||||0.91|TWO_SIDED|97.5|-22.2|24.59||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 48.||24.59|-22.2|0.91
74059004|NCT04636437|147670214|SUPERIORITY||Mean Difference (Net)|-7.1||||0.48|TWO_SIDED|97.5|-29.7|15.47||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 48.||15.47|-29.7|0.48
74059005|NCT04636437|147670215|SUPERIORITY||Mean Difference (Net)|-15.2||||0.3|TWO_SIDED|97.5|-48.6|18.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 24.||18.20|-48.6|0.30
74059006|NCT04636437|147670215|SUPERIORITY||Mean Difference (Net)|-18.5||||0.21|TWO_SIDED|97.5|-51.8|14.76||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 24.||14.76|-51.8|0.21
74059007|NCT04636437|147670216|SUPERIORITY||Mean Difference (Net)|-2.84||||0.58|TWO_SIDED|97.5|-14.4|8.72||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 48.||8.72|-14.4|0.58
74059008|NCT04636437|147670216|SUPERIORITY||Mean Difference (Net)|-6.88||||0.16|TWO_SIDED|97.5|-18.0|4.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 48.||4.20|-18.0|0.16
74059009|NCT04636437|147670217|SUPERIORITY||Mean Difference (Net)|-2.92||||0.47|TWO_SIDED|97.5|-12.1|6.27||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 24.||6.27|-12.1|0.47
74101556|NCT01297985|147752993|SUPERIORITY||MIXREG Estimate|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this second model included anxiety symptoms as moderator||"We tested 3 moderating variables: depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes anxiety as the moderator (high anxiety X time X study condition)"||||0.01
74101557|NCT01297985|147752993|SUPERIORITY||MIXREG Estimate|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.022|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this third model included the general symptom distress as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes general symptom distress as the moderator (high symptom distress X time X study condition)"||||.022
74101558|NCT01297985|147752994|SUPERIORITY||MIXREG Estimate|0.33|STANDARD_ERROR_OF_MEAN|0.012|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in Hopefulness that would be maintained longitudinally||||<.01
74101559|NCT01297985|147752995|SUPERIORITY||MIXREG Estimate|0.12|STANDARD_ERROR_OF_MEAN|0.04|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This analysis Mixed Effects Random Regression Modeling to test whether self-advocacy scores changed overtime by study condition status. Reported below are findings for the self-advocacy assertiveness sub scale.||||<0.01
74101560|NCT01297985|147752996|SUPERIORITY||MIXREG Estimate|0.042|STANDARD_ERROR_OF_MEAN|0.018||0.017|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.017
74101561|NCT01044264|147753031|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|BE of the test to reference in the per protocol population|Wilcoxon Rank Sum Test|100.0|||||TWO_SIDED|90.0|92.47|113.54|||Wilcoxon Rank Sum Test|||||113.54|92.47|
74101562|NCT04345913|147753044|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.5259|||||||Log Rank|||||||0.5259
74101563|NCT04345913|147753049|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.706|||||||Log Rank|||||||0.7060
74101564|NCT01406444|147753064|SUPERIORITY|||||||0.03|||||||Linear random effects model|||||||0.03
74101565|NCT01406444|147753065|SUPERIORITY|||||||0.002|||||||Linear random effects model|||||||0.002
74101566|NCT01406444|147753065|SUPERIORITY|||||||0.04|||||||Linear random effects model|||||||0.04
74059010|NCT04636437|147670217|SUPERIORITY||Mean Difference (Net)|-15.1|||<|0.001|TWO_SIDED|97.5|-24.2|-5.91||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 24.||-5.91|-24.2|<0.001
74059011|NCT04636437|147670218|SUPERIORITY||Mean Difference (Net)|0.8||||0.79|TWO_SIDED|97.5|-6.17|7.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 48.||7.77|-6.17|0.79
74059012|NCT04636437|147670218|SUPERIORITY||Mean Difference (Net)|-5.46||||0.063|TWO_SIDED|97.5|-12.1|1.16||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 48.||1.16|-12.1|0.063
74101567|NCT02211417|147753085|SUPERIORITY|||||||0.057|||||||Cochran-Mantel-Haenszel|||||||0.057
74059013|NCT04636437|147670219|SUPERIORITY||Mean Difference (Net)|-1.38||||0.27|TWO_SIDED|97.5|-4.21|1.45||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 24.||1.45|-4.21|0.27
74059014|NCT04636437|147670219|SUPERIORITY||Mean Difference (Net)|-5.45|||<|0.001|TWO_SIDED|97.5|-8.25|-2.66||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 24.||-2.66|-8.25|<0.001
74059015|NCT04636437|147670220|SUPERIORITY||Mean Difference (Net)|1.55||||0.77|TWO_SIDED|97.5|-10.3|13.44||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 48.||13.44|-10.3|0.77
74101568|NCT00490841|147753101|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||1-sided exact binomial test|||"objective is to demonstrate the binary restenosis rate at 9 months is \< 28.6% OPC. Assumptions for the primary endpoint analysis:~* H0: Restenosis Rate ≥ 28.6%~* HA: Restenosis Rate \< 28.6%~* Assumed binary restenosis rate = 20%~* Power = 80%~* One-sided type I error = 5%~With the above assumptions, 161 samples would be required. To account for approximately 20% lost to follow-up rate, 202 subjects will be enrolled in the study. The sample size calculation was performed using PASS 2005."||||< 0.0001
74101569|NCT00345631|147753130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.68|||<|0.0001|TWO_SIDED|95.0|-19.04|-12.31||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis: The mean time to hemostasis for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"||-12.31|-19.04|<0.0001
74101570|NCT00345631|147753131|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.7||||0.0028|TWO_SIDED|95.0|-5.53|-1.87||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis:The mean time to ambulation for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"||-1.87|-5.53|0.0028
74101571|NCT00345631|147753132|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is adequate to rule out a 4% or larger disadvantage for VCD vs. MC (null hypothesis: 2.5% MC vs. 6.5% VCD) in the incidence of major complications for VCD vs. MC using a 95% upper confidence bound for the VCD - MC difference with 80% power and a 5% one-sided Type I error|Mean Difference (Final Values)|0.0||||0.0006|ONE_SIDED|95.0||1.14||P-value was calculated using unconditional exact test of non-inferiority for difference of two binomial proportions (VCD vs. MC) with a margin of 4%.|unconditional exact test|||Based on pre-planned hypotheses, a minimum sample size of 390 randomized patients (260 VCD patients and 130 MC patients) would demonstrate non-inferiority for the primary safety endpoint and superiority for both co-primary effectiveness endpoints in comparing VCD vs. MC.||1.14||0.0006
74101572|NCT00345631|147753133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.154|TWO_SIDED|95.0|-7.84|0.45|||t-test, 2 sided|||Null hypothesis: The mean time to eligibility for hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.||0.45|-7.84|0.1540
74101573|NCT00345631|147753134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.3612|TWO_SIDED|95.0|-7.46|2.31|||t-test, 2 sided|||Null hypothesis: The mean time to hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.||2.31|-7.46|0.3612
74101574|NCT00345631|147753137|SUPERIORITY_OR_OTHER||Proportion difference|0.7||||0.85|TWO_SIDED|95.0|-4.8|7.4|||t-test, 2 sided|||Null hypothesis: The percentages of patients achieving procedure success between the vascular closure device and manual compression arms are equal.||7.4|-4.8|0.85
74101575|NCT04700137|147753162|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.31|TWO_SIDED|95.0|-3.0|1.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.|A T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. Higher T-score indicates higher loneliness.|Difference in loneliness among patients by intervention arm at follow-up (6 months).||1.0|-3.0|0.31
74101576|NCT04700137|147753162|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.83|TWO_SIDED|95.0|-1.8|2.2||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.|A T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. Higher T-score indicates higher loneliness.|Difference in loneliness among healthcare providers/staff by intervention arm at follow-up (6 months).||2.2|-1.8|0.83
74101577|NCT04700137|147753163|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.5||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in suicidal ideation and behavior (C-SSRS) among patients by intervention arm at follow-up (6 months).||0.5|0.0|0.05
74101578|NCT04700137|147753163|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.2|TWO_SIDED|95.0|-0.4|0.1||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in suicidal ideation and behavior (C-SSRS) among healthcare providers/staff by intervention arm at follow-up (6 months).||0.1|-0.4|0.2
74059016|NCT04636437|147670220|SUPERIORITY||Mean Difference (Net)|-5.23||||0.3|TWO_SIDED|97.5|-16.7|6.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 48.||6.20|-16.7|0.30
74059017|NCT04636437|147670221|SUPERIORITY||Mean Difference (Net)|0.18||||0.96|TWO_SIDED|97.5|-8.78|9.15||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 24.||9.15|-8.78|0.96
74059018|NCT04636437|147670221|SUPERIORITY||Mean Difference (Net)|-6.32||||0.11|TWO_SIDED|97.5|-15.2|2.55||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 24.||2.55|-15.2|0.11
74059019|NCT04636437|147670222|SUPERIORITY||Mean Difference (Net)|8.07||||0.16|TWO_SIDED|97.5|-4.93|21.06||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 48.||21.06|-4.93|0.16
74059020|NCT04636437|147670222|SUPERIORITY||Mean Difference (Net)|8.89||||0.1|TWO_SIDED|97.5|-3.37|21.15||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 48.||21.15|-3.37|0.10
74059021|NCT04636437|147670223|SUPERIORITY||Mean Difference (Net)|4.28||||0.37|TWO_SIDED|97.5|-6.42|14.99||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 24.||14.99|-6.42|0.37
74059022|NCT04636437|147670223|SUPERIORITY||Mean Difference (Net)|0.37||||0.94|TWO_SIDED|97.5|-10.0|10.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 24.||10.77|-10.0|0.94
74059023|NCT04636437|147670224|SUPERIORITY||Mean Difference (Net)|2.77||||0.2|TWO_SIDED|97.5|-2.08|7.63||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 48.||7.63|-2.08|0.20
74059024|NCT04636437|147670224|SUPERIORITY||Mean Difference (Net)|2.21||||0.28|TWO_SIDED|97.5|-2.44|6.87||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 48.||6.87|-2.44|0.28
74059025|NCT04636437|147670225|SUPERIORITY||Mean Difference (Net)|1.79||||0.24|TWO_SIDED|97.5|-1.68|5.25||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 24.||5.25|-1.68|0.24
74059026|NCT04636437|147670225|SUPERIORITY||Mean Difference (Net)|-0.57||||0.7|TWO_SIDED|97.5|-3.91|2.78||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 24.||2.78|-3.91|0.70
74059027|NCT04636437|147670227|SUPERIORITY|||||||0.43||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of Grade ≥3 AEs from entry to week 48.||||0.43
74059028|NCT04636437|147670227|SUPERIORITY|||||||0.26||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of Grade ≥3 AEs from entry to week 48.||||0.26
74059029|NCT04636437|147670228|SUPERIORITY|||||||0.008||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of \>10% reduction in CrCl from entry to week 48.||||0.008
74059030|NCT04636437|147670228|SUPERIORITY|||||||0.068||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of \>10% reduction in CrCl from entry to week 48.||||0.068
74059031|NCT04636437|147670229|SUPERIORITY|||||||0.2||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of premature discontinuation of study treatment from entry to week 48.||||0.20
74059032|NCT04636437|147670229|SUPERIORITY|||||||0.56||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of premature discontinuation of study treatment from entry to week 48.||||0.56
74059033|NCT04636437|147670230|SUPERIORITY||Mean Difference (Net)|3.43||||0.13|TWO_SIDED|97.5|-1.62|8.47||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in total fat from entry to week 48.||8.47|-1.62|0.13
74059034|NCT04636437|147670230|SUPERIORITY||Mean Difference (Net)|-0.09||||0.97|TWO_SIDED|97.5|-4.89|4.72||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in total fat from entry to week 48.||4.72|-4.89|0.97
74059035|NCT04636437|147670231|SUPERIORITY||Mean Difference (Net)|0.31||||0.78|TWO_SIDED|97.5|-2.18|2.8||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lean mass from entry to week 48.||2.80|-2.18|0.78
74059036|NCT04636437|147670231|SUPERIORITY||Mean Difference (Net)|1.24||||0.23|TWO_SIDED|97.5|-1.11|3.59||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lean mass from entry to week 48.||3.59|-1.11|0.23
74059037|NCT04636437|147670232|SUPERIORITY||Mean Difference (Net)|3.71||||0.18|TWO_SIDED|97.5|-2.48|9.9||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry trunk fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in trunk fat from entry to week 48.||9.90|-2.48|0.18
74059038|NCT04636437|147670232|SUPERIORITY||Mean Difference (Net)|-1.35||||0.6|TWO_SIDED|97.5|-7.23|4.53||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry trunk fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in trunk fat from entry to week 48.||4.53|-7.23|0.60
74059039|NCT04636437|147670233|SUPERIORITY||Mean Difference (Net)|4.19||||0.094|TWO_SIDED|97.5|-1.45|9.83||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear|||Null hypothesis: There is no difference between the two arms in percent change in limb fat from entry to week 48.|Mean difference and CI come from a linear regression model adjusting for entry limb fat, sex, and race (Black and not Black).|9.83|-1.45|0.094
74059040|NCT04636437|147670233|SUPERIORITY||Mean Difference (Net)|1.76||||0.46|TWO_SIDED|97.5|-3.59|7.11||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear|||Null hypothesis: There is no difference between the two arms in percent change in limb fat from entry to week 48.|Mean difference and CI come from a linear regression model adjusting for entry limb fat, sex, and race (Black and not Black).|7.11|-3.59|0.46
74059041|NCT04636437|147670234|SUPERIORITY||Mean Difference (Net)|2.19||||0.26|TWO_SIDED|97.5|-2.19|6.56||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry appendicular lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in appendicular lean mass from entry to week 48.||6.56|-2.19|0.26
74059042|NCT04636437|147670234|SUPERIORITY||Mean Difference (Net)|3.15||||0.084|TWO_SIDED|97.5|-0.96|7.25||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry appendicular lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in appendicular lean mass from entry to week 48.||7.25|-0.96|0.084
74059043|NCT04636437|147670235|SUPERIORITY||Mean Difference (Net)|0.78||||0.19|TWO_SIDED|97.5|-0.57|2.13||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry hip bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in hip bone mineral density from entry to week 48.||2.13|-0.57|0.19
74059044|NCT04636437|147670235|SUPERIORITY||Mean Difference (Net)|-0.64||||0.27|TWO_SIDED|97.5|-1.93|0.66||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry hip bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in hip bone mineral density from entry to week 48.||0.66|-1.93|0.27
74059045|NCT04636437|147670236|SUPERIORITY||Mean Difference (Net)|0.5||||0.58|TWO_SIDED|97.5|-1.57|2.58||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lumbar spine bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lumbar spine bone mineral density from entry to week 48.||2.58|-1.57|0.58
73881853|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4731|TWO_SIDED|95.0|-0.63|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.29|-0.63|0.4731
74059046|NCT04636437|147670236|SUPERIORITY||Mean Difference (Net)|0.05||||0.95|TWO_SIDED|97.5|-1.93|2.03||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lumbar spine bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lumbar spine bone mineral density from entry to week 48.||2.03|-1.93|0.95
74059047|NCT03539952|147670285|NON_INFERIORITY|The primary efficacy analysis utilized the serum NCC values from all study visits that were analyzed using a restricted maximum likelihood based general linear model for correlated data. The correlation due to repeated measures was modeled by specifying the variance covariance matrix. Considering a comparison of means in both treatment arms (D-penicillamine minus TETA 4HCl) at the 1-sided 2.5% level of Type 1 error, a non-inferiority margin of 50 μg/L was used.|Mean Difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|7.49|||TWO_SIDED|||||||||The primary endpoint was the assessment of the non-inferiority of TETA 4HCl in relation to D-penicillamine. The non-inferiority assessment was made on the basis of the mean serum NCC level at Week 36.||||
74059048|NCT01233284|147670290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.09|0.186|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.186|0.090|<0.0001
74059049|NCT01233284|147670290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.08|0.176|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.176|0.080|<0.0001
73881854|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.031|TWO_SIDED|95.0|-0.98|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||-0.05|-0.98|0.0310
73888214|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.4||||0.7875|TWO_SIDED|95.0|-94.7|71.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.9|-94.7|0.7875
74059050|NCT01233284|147670290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.14|0.236|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.236|0.140|<0.0001
74059051|NCT01233284|147670291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.078|0.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.173|0.078|<0.0001
74059052|NCT01233284|147670291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.179|0.084|<0.0001
74059053|NCT01233284|147670291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.096|0.191|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.191|0.096|<0.0001
74059054|NCT01233284|147670292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.083|0.175|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.175|0.083|<0.0001
74059055|NCT01233284|147670292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.081|0.172|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.172|0.081|<0.0001
74101579|NCT04700137|147753164|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.45|TWO_SIDED|95.0|-1.5|0.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in depression (PHQ-9) among patients by intervention arm at follow-up (6 months).||0.7|-1.5|0.45
74101580|NCT04700137|147753164|SUPERIORITY||Median Difference (Final Values)|0.3||||0.51|TWO_SIDED|95.0|-0.7|1.3||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in depression (PHQ-9) among healthcare providers/staff by intervention arm at follow-up (6 months).||1.3|-0.7|0.51
74059056|NCT01233284|147670292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.132|0.224|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.224|0.132|<0.0001
74059057|NCT01233284|147670293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.027||0.0034||95.0|0.026|0.132|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.132|0.026|0.0034
74059058|NCT01233284|147670293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.027||0.0087||95.0|0.018|0.124|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.124|0.018|0.0087
74059059|NCT01233284|147670293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.085|0.19|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.190|0.085|<0.0001
74059060|NCT01233284|147670294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.03||0.0732||95.0|-0.005|0.113|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.113|-0.005|0.0732
74059061|NCT01233284|147670294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.03||0.0177||95.0|0.012|0.131|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.131|0.012|0.0177
74059062|NCT01233284|147670294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.03||0.0012||95.0|0.039|0.157|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.157|0.039|0.0012
74059063|NCT01233284|147670295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.026||0.0149||95.0|0.013|0.115|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.115|0.013|0.0149
74059064|NCT01233284|147670295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.026||0.0043||95.0|0.024|0.126|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.126|0.024|0.0043
74059065|NCT01233284|147670295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.086|0.189|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.189|0.086|<0.0001
74059066|NCT01233284|147670299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.55|STANDARD_ERROR_OF_MEAN|3.737|<|0.0001||95.0|11.204|25.895|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||25.895|11.204|<0.0001
74059067|NCT01233284|147670299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.895|STANDARD_ERROR_OF_MEAN|3.737|<|0.0001||95.0|10.55|25.24|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||25.240|10.550|<0.0001
74059068|NCT01233284|147670299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.846|STANDARD_ERROR_OF_MEAN|3.739|<|0.0001||95.0|13.497|28.195|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||28.195|13.497|<0.0001
74059069|NCT01233284|147670300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.251|STANDARD_ERROR_OF_MEAN|3.77|<|0.0001||95.0|13.84|28.662|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||28.662|13.840|<0.0001
74101581|NCT04700137|147753165|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.54|TWO_SIDED|95.0|-1.3|0.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in anxiety (GAD-7) among patients by intervention arm at follow-up (6 months).||0.7|-1.3|0.54
73881855|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.132|TWO_SIDED|95.0|-0.84|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.11|-0.84|0.1320
74101582|NCT04700137|147753165|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.04|TWO_SIDED|95.0|0.1|2.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in anxiety (GAD-7) among healthcare providers/staff by intervention arm at follow-up (6 months).||2.0|0.1|0.04
74101583|NCT04700137|147753166|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.1|1.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors.|T-score of 50 = mean of the US general population (2010 Census); 10 T-score units = one standard deviation. Higher T-scores = higher stress. T-scores equal to or greater than 60.5 (adults) or 60.8 (adolescents) are moderate or high risk.|Change in stress from baseline to 6 months among patients.||1.7|-2.1|0.84
73888215|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|115.0||||0.0066|TWO_SIDED|95.0|32.6|197.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||197.4|32.6|0.0066
74101584|NCT04700137|147753166|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.18|TWO_SIDED|95.0|-0.7|3.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors.|T-score of 50 = mean of the US general population (2010 Census); 10 T-score units = one standard deviation. Higher T-scores = higher stress. T-scores equal to or greater than 60.5 (adults) or 60.8 (adolescents) are moderate or high risk.|Change in stress from baseline to 6 months among healthcare providers/staff.||3.7|-0.7|0.18
74101585|NCT04700137|147753167|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.38|TWO_SIDED|95.0|-0.6|1.6||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in perceived burdensomeness (INQ15) among patients by intervention arm at follow-up (6 months).||1.6|-0.6|0.38
74101586|NCT04700137|147753167|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.81|TWO_SIDED|95.0|-0.8|1.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in perceived burdensomeness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).||1.0|-0.8|0.81
74101587|NCT04700137|147753167|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.73|TWO_SIDED|95.0|-2.6|1.8||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in thwarted belongingness (INQ15) among patients by intervention arm at follow-up (6 months).||1.8|-2.6|0.73
74101588|NCT04700137|147753167|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.24|TWO_SIDED|95.0|-0.8|3.2||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in thwarted belongingness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).||3.2|-0.8|0.24
74101589|NCT04700137|147753169|SUPERIORITY||Risk Difference (RD)|-5.6||||0.12|TWO_SIDED|95.0|-12.5|1.4||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased tobacco use among patients randomized to CC+ vs CC||1.4|-12.5|0.12
74101590|NCT04700137|147753169|SUPERIORITY||Risk Difference (RD)|-6.1||||0.03|TWO_SIDED|95.0|-11.5|-0.7||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased tobacco use among healthcare providers/staff randomized to CC+ vs CC||-0.7|-11.5|0.03
74101591|NCT04700137|147753169|SUPERIORITY||Risk Difference (RD)|-1.1||||0.83|TWO_SIDED|95.0|-10.7|8.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased alcohol use among patients randomized to CC+ vs CC||8.5|-10.7|0.83
74101592|NCT04700137|147753169|SUPERIORITY||Risk Difference (RD)|2.2||||0.67|TWO_SIDED|95.0|-8.0|12.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased alcohol use among healthcare providers/staff randomized to CC+ vs CC||12.5|-8.0|0.67
74101593|NCT04700137|147753169|SUPERIORITY||Risk Difference (RD)|2.9||||0.42|TWO_SIDED|95.0|-4.1|9.9||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased marijuana/cannabis use among patients randomized to CC+ vs CC||9.9|-4.1|0.42
74101594|NCT04700137|147753169|SUPERIORITY||Risk Difference (RD)|-2.1||||0.53|TWO_SIDED|95.0|-8.7|4.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased marijuana/cannabis use among healthcare providers/staff randomized to CC+ vs CC||4.5|-8.7|0.53
74101595|NCT04700137|147753169|SUPERIORITY||Risk Difference (RD)|-2.5||||0.2|TWO_SIDED|95.0|-6.3|1.4||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased illicit drug use among patients randomized to CC+ vs CC||1.4|-6.3|0.20
74101596|NCT04700137|147753169|SUPERIORITY||Risk Difference (RD)|-0.7||||0.62|TWO_SIDED|95.0|-3.4|2.0||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased illicit drug use among healthcare providers/staff randomized to CC+ vs CC||2.0|-3.4|0.62
74101597|NCT04700137|147753170|SUPERIORITY||Risk Difference (RD)|-4.5||||0.41|TWO_SIDED|95.0|-15.4|6.3||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Difference in proportion of patients attending mental healthcare appointments by intervention arm at follow-up (6 months).||6.3|-15.4|0.41
74101598|NCT04700137|147753170|SUPERIORITY||Risk Difference (RD)|5.5||||0.31|TWO_SIDED|95.0|-5.2|16.2||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Difference in proportion of healthcare providers/staff attending mental healthcare appointments by intervention arm at follow-up (6 months).||16.2|-5.2|0.31
74101599|NCT02687529|147753183|EQUIVALENCE|The number of positive and negative CST001 assay results for each subject, across all sites and operators were compared. In order for a subject to have a concordant result, the same assay call must be observed for all replicates across all sites (6/6).|proportion of concordant calls|83.33|||||TWO_SIDED|95.0|72.13|91.38||||||||91.38|72.13|
74101600|NCT02374138|147753184|SUPERIORITY|||||||0.93||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Months||||0.93
74101601|NCT02374138|147753185|SUPERIORITY|||||||0.87||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 month follow up||||0.87
74101602|NCT02374138|147753185|SUPERIORITY|||||||0.25||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up||||0.25
74101603|NCT02374138|147753187|SUPERIORITY|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 6 Month Follow Up||||0.35
74101604|NCT02374138|147753187|SUPERIORITY|||||||0.34||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 12 Month Follow Up||||0.34
74101605|NCT02374138|147753187|SUPERIORITY|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA Use at 6 Months||||0.35
74101606|NCT02374138|147753187|SUPERIORITY|||||||0.62||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA use at 12 Month Follow Up||||0.62
74101607|NCT02374138|147753188|SUPERIORITY|||||||0.63||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED visits over 6 months||||0.63
74059070|NCT01233284|147670300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.577|STANDARD_ERROR_OF_MEAN|3.77||0.0001||95.0|7.166|21.988|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||21.988|7.166|0.0001
74059071|NCT01233284|147670300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.581|STANDARD_ERROR_OF_MEAN|3.773|<|0.0001||95.0|14.166|28.997|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||28.997|14.166|<0.0001
74059072|NCT01233284|147670301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.114|STANDARD_ERROR_OF_MEAN|0.635||0.8574||95.0|-1.363|1.134|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||1.134|-1.363|0.8574
74059073|NCT01233284|147670301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.635||0.3954||95.0|-1.789|0.708|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.708|-1.789|0.3954
74059074|NCT01233284|147670301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.636||0.9034||95.0|-1.327|1.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||1.173|-1.327|0.9034
74059075|NCT01233284|147670302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.233|STANDARD_ERROR_OF_MEAN|0.107||0.0296||95.0|-0.443|-0.023|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||-0.023|-0.443|0.0296
74059076|NCT01233284|147670302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.107||0.0454||95.0|-0.424|-0.004|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||-0.004|-0.424|0.0454
74101608|NCT02374138|147753188|SUPERIORITY|||||||0.44||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED Visits between 6 and 12 Month follow up||||0.44
74101609|NCT02374138|147753189|SUPERIORITY|||||||0.98||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids over 6 months||||0.98
74101610|NCT02374138|147753189|SUPERIORITY|||||||0.48||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids between 6m and 12m FU||||0.48
74101611|NCT02374138|147753190|SUPERIORITY|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up||||0.32
74059077|NCT01233284|147670302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.107||0.061||95.0|-0.41|0.009|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.009|-0.410|0.0610
74059078|NCT01233284|147670303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.063||0.0183||95.0|-0.273|-0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||-0.025|-0.273|0.0183
74059079|NCT01233284|147670303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|0.063||0.0288||95.0|-0.262|-0.014|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||-0.014|-0.262|0.0288
74059080|NCT01233284|147670303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.111|STANDARD_ERROR_OF_MEAN|0.063||0.0781||95.0|-0.235|0.013|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.013|-0.235|0.0781
74059081|NCT01233284|147670304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.055||0.1303||95.0|-0.193|0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.025|-0.193|0.1303
74059082|NCT01233284|147670304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.055||0.2191||95.0|-0.177|0.041|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.041|-0.177|0.2191
74059083|NCT01233284|147670304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.056||0.1163||95.0|-0.196|0.022|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.022|-0.196|0.1163
74059084|NCT01233284|147670305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.032||0.7501||95.0|-0.073|0.052|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.052|-0.073|0.7501
74059085|NCT01233284|147670305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.032||0.8401||95.0|-0.069|0.056|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.056|-0.069|0.8401
74059086|NCT01233284|147670305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.032||0.3237||95.0|-0.094|0.031|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.031|-0.094|0.3237
74059087|NCT01233284|147670306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.079||0.1402|TWO_SIDED|95.0|-0.04|0.276||MMRM, adjusted for treatment, period, patient and study baseline.|Mixed Models Analysis||Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.276|-0.040|0.1402
74059088|NCT01233284|147670306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.079||0.0656|TWO_SIDED|95.0|-0.01|0.305|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.305|-0.010|0.0656
74059089|NCT01233284|147670306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.079||0.0766|TWO_SIDED|95.0|-0.015|0.299|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.299|-0.015|0.0766
74059090|NCT01233284|147670306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.084||0.3371|TWO_SIDED|95.0|-0.086|0.249|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.249|-0.086|0.3371
74101612|NCT02374138|147753190|SUPERIORITY|||||||0.06||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up||||0.06
74101613|NCT02374138|147753191|SUPERIORITY|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month follow up||||0.32
74101614|NCT02374138|147753191|SUPERIORITY|||||||0.44||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up||||0.44
74059091|NCT01233284|147670306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.084||0.1097|TWO_SIDED|95.0|-0.031|0.303|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.303|-0.031|0.1097
74059092|NCT01233284|147670306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.084||0.022|TWO_SIDED|95.0|0.029|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.363|0.029|0.0220
74059093|NCT01233284|147670306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.078||0.2062|TWO_SIDED|95.0|-0.056|0.256|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.256|-0.056|0.2062
74059094|NCT01233284|147670306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.078||0.0731|TWO_SIDED|95.0|-0.014|0.297|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.297|-0.014|0.0731
74059095|NCT01233284|147670306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.078||0.0333|TWO_SIDED|95.0|0.014|0.324|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.324|0.014|0.0333
74059096|NCT01233284|147670307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|0.099||0.2451|TWO_SIDED|95.0|-0.081|0.312|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.312|-0.081|0.2451
74059097|NCT01233284|147670307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.099||0.0379|TWO_SIDED|95.0|0.012|0.405|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.405|0.012|0.0379
74059098|NCT01233284|147670307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.099||0.0957|TWO_SIDED|95.0|-0.03|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.363|-0.030|0.0957
74059099|NCT01233284|147670307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.104||0.5207|TWO_SIDED|95.0|-0.139|0.273|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.273|-0.139|0.5207
74059100|NCT01233284|147670307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.104||0.0606|TWO_SIDED|95.0|-0.009|0.404|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.404|-0.009|0.0606
74059101|NCT01233284|147670307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.104||0.0855|TWO_SIDED|95.0|-0.026|0.387|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.387|-0.026|0.0855
74059102|NCT01233284|147670307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.099||0.3564|TWO_SIDED|95.0|-0.104|0.287|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.287|-0.104|0.3564
74059103|NCT01233284|147670307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.099||0.0424|TWO_SIDED|95.0|0.007|0.399|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.399|0.007|0.0424
74059104|NCT01233284|147670307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.099||0.0815|TWO_SIDED|95.0|-0.022|0.37|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.370|-0.022|0.0815
74059105|NCT01821391|147670328|SUPERIORITY||||||=|0.2665|||||||Paired Student's t test|||||||=0.2665
74059106|NCT01977482|147670407|SUPERIORITY_OR_OTHER||E0 (g/dL)|-0.664|||||TWO_SIDED|95.0|-0.96|-0.387|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-0.387|-0.960|
74059107|NCT01977482|147670407|SUPERIORITY_OR_OTHER||ED50 (milligrams[mg])|33.531|||||TWO_SIDED|95.0|15.566|48.948|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||48.948|15.566|
74059108|NCT01977482|147670407|SUPERIORITY_OR_OTHER||Emax (g/dL)|5.234||||||95.0|2.691|7.94|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||7.940|2.691|
74059109|NCT01977482|147670407|SUPERIORITY_OR_OTHER||Gamma|1.145|||||TWO_SIDED|95.0|0.748|1.738|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.738|0.748|
74059110|NCT01977482|147670407|SUPERIORITY_OR_OTHER||Var|1.012|||||TWO_SIDED|95.0|0.84|1.234|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.234|0.840|
74059111|NCT01977482|147670407|SUPERIORITY_OR_OTHER||Alpha|-0.206|||||TWO_SIDED|95.0|-0.397|-0.014|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-0.014|-0.397|
74059112|NCT01977482|147670407|SUPERIORITY_OR_OTHER||Minimally Effective Dose (MED) (mg)|0.418|||||TWO_SIDED|95.0|0.0|2.342|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||2.342|0.000|
74059113|NCT01977482|147670407|SUPERIORITY_OR_OTHER||Dose that achieves a change of -0.25g/dL|2.423|||||TWO_SIDED|95.0|0.0|4.15|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||4.150|0.000|
74059114|NCT01977482|147670407|SUPERIORITY_OR_OTHER||Target Dose (TD) (mg)|4.406|||||TWO_SIDED|95.0|2.544|5.995|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||5.995|2.544|
74059115|NCT01977482|147670407|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.25 g/dL|6.43|||||TWO_SIDED|95.0|4.698|8.01|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||8.010|4.698|
74059116|NCT01977482|147670407|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.5 g/dL|8.542|||||TWO_SIDED|95.0|6.931|10.523|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||10.523|6.931|
74059117|NCT01977482|147670407|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.75 g/dL|10.8|||||TWO_SIDED|95.0|9.024|14.004|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||14.004|9.024|
74101615|NCT02374138|147753192|SUPERIORITY|||||||0.7||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up||||0.70
73881856|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1212|TWO_SIDED|95.0|-0.85|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.10|-0.85|0.1212
74059118|NCT01977482|147670407|SUPERIORITY_OR_OTHER||Dose that achieves a change of 1 g/dL|13.248|||||TWO_SIDED|95.0|10.891|18.916|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||18.916|10.891|
73881857|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.5689|TWO_SIDED|95.0|-0.62|0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.34|-0.62|0.5689
74059119|NCT05554471|147670426|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Hypothesis: the time to ambulation for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was used.||||<0.001
74059120|NCT05554471|147670427|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Hypothesis: the time to hemostasis for the MYNX CONTROL™ Venous VCD device is at least 5 minutes less than manual compression.||||<0.001
74059121|NCT05554471|147670429|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Hypothesis: The time to discharge eligibility for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was used||||<0.001
74059122|NCT04880850|147670453|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin glargine) was strictly below 0.3%.|Treatment difference|0.02|||<|0.0001|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||The response and change from baseline in response after 26 weeks were analysed using an analysis of covariance (ANCOVA) model with treatment, region and personal continuous glucose monitoring (CGM) device use as fixed factors, and baseline response as covariate.||0.15|-0.11|<0.0001
74059123|NCT03417102|147670464|SUPERIORITY||ABR ratio|0.092|||<|0.0001|TWO_SIDED|95.0|0.044|0.192||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.192|0.044|<0.0001
74059124|NCT03417102|147670466|SUPERIORITY||ABR ratio|0.108|||<|0.0001|TWO_SIDED|95.0|0.056|0.207||P-value derived from NB regression model, accounted for different follow-up times during TP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.207|0.056|<0.0001
74059125|NCT03417102|147670468|SUPERIORITY||ABR ratio|0.056|||<|0.0001|TWO_SIDED|95.0|0.026|0.121||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.121|0.026|<0.0001
74059126|NCT03417102|147670470|SUPERIORITY||ABR ratio|0.098|||<|0.0001|TWO_SIDED|95.0|0.046|0.21||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.210|0.046|<0.0001
74059127|NCT03417102|147670472|SUPERIORITY||Least Square (LS) Mean difference|-28.72|||<|0.0001|TWO_SIDED|95.0|-39.07|-18.37||Analysis of Covariance (ANCOVA) model included treatment arm and randomization strata of number of bleeds (\<=10, \> 10) as fixed effects, Baseline score as a covariate. Significance threshold was at 0.05.|ANCOVA|||||-18.37|-39.07|<0.0001
74059128|NCT03417102|147670473|SUPERIORITY||LS Mean difference|-14.85|||<|0.0001|TWO_SIDED|95.0|-21.37|-8.33||ANCOVA model included treatment arm and randomization strata of number of bleeds (\<=10, \> 10) as fixed effects, Baseline score as a covariate. Significance threshold was at 0.05.|ANCOVA|||||-8.33|-21.37|<0.0001
74059129|NCT02062385|147670476|SUPERIORITY_OR_OTHER||1 - (Incidence V260 / Incidence Placebo)|69.3|||<|0.001|TWO_SIDED|95.0|54.5|79.7|||Clopper-Pearson|To calculate the confidence interval and associated p-value, an exact conditional method based on a Poisson distribution was used.||V260 will be considered efficacious if the lower bound of the two-sided confidence interval for efficacy is \>0% at the final analysis||79.7|54.5|<0.001
74059130|NCT00710840|147670484|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||The primary outcome, difference in quadriceps torque between intervention (TKA Min) and Control TKA at 4 weeks, was tested using an analysis of covariance model. Confirmatory measures were evaluated at 4 and 12 weeks after surgery in the same way. Baseline characteristics of the treatment groups were compared using 2-sample t tests for continuous measures or a χ2 test for independent proportions for categorical measures. A 2-sided α level of .05 was designated for statistical significance.||||0.07
74059131|NCT00710840|147670485|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.92
74059132|NCT00710840|147670486|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.48
74059133|NCT00710840|147670487|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.41
74059134|NCT00706901|147670502|NON_INFERIORITY_OR_EQUIVALENCE|Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
73881858|NCT03192176|147297636|SUPERIORITY||0.1|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.734|TWO_SIDED|95.0|-0.39|0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.55|-0.39|0.7340
74059135|NCT00706901|147670502|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|TWO_SIDED||||||zero-hurdle Poisson model|||||||0.02
74059136|NCT00706901|147670503|NON_INFERIORITY_OR_EQUIVALENCE|A Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
74059137|NCT00706901|147670503|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.0002|TWO_SIDED||||||Zero-hurdle Poisson model|||||||.0002
74059138|NCT00706901|147670504|NON_INFERIORITY_OR_EQUIVALENCE|To examine differences between GMI and TCC on SECs, a two-component Weibull mixture model for effectively dealing with zero-heavy continuous data was conducted.||||||0.04|TWO_SIDED||||||Weibull mixture model|||||||0.04
74059139|NCT00706901|147670504|NON_INFERIORITY_OR_EQUIVALENCE|A generalized linear mixed model with correlated errors to account for correlation between repeated measurements of the response within subjects was conducted.||||||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
74059140|NCT00706901|147670505|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
74059141|NCT00706901|147670505|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.0001|TWO_SIDED||||||Zero-hurdle Poisson model|||||||<.0001
74059142|NCT00706901|147670506|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.0001|TWO_SIDED||||||Zero inflated Poisson model|||||||<.0001
74059143|NCT00706901|147670506|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|TWO_SIDED||||||Zero-hurdle Poisson model|||||||0.02
74059144|NCT00706901|147670507|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.||||||0.17|TWO_SIDED||||||Zero inflated Poisson model|||||||0.17
74059145|NCT00706901|147670507|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.67|TWO_SIDED||||||Zero-hurdle Poisson model|||||||0.67
74059146|NCT01939834|147670509|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74059147|NCT03504839|147670524|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
74059148|NCT00798707|147670557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.452|TWO_SIDED|95.0|-0.75|1.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.||1.69|-0.75|0.452
74059149|NCT00798707|147670557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.016|TWO_SIDED|95.0|0.28|2.72||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.||2.72|0.28|0.016
74059150|NCT00798707|147670558|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.160
74059151|NCT00798707|147670558|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure.p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.028
74101616|NCT02374138|147753192|SUPERIORITY|||||||0.8||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up||||0.80
74059152|NCT00798707|147670559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.066|TWO_SIDED|95.0|-0.01|0.39|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.39|-0.01|0.066
74059153|NCT00798707|147670559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.038|TWO_SIDED|95.0|0.01|0.41|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.41|0.01|0.038
74059154|NCT00798707|147670560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.242|TWO_SIDED|95.0|-0.68|2.68|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||2.68|-0.68|0.242
74059155|NCT00798707|147670560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.06||||0.016|TWO_SIDED|95.0|0.39|3.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||3.73|0.39|0.016
74059156|NCT00798707|147670561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.802|TWO_SIDED|95.0|-0.62|0.8|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.80|-0.62|0.802
74059157|NCT00798707|147670561|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.72||||0.048|TWO_SIDED|95.0|0.01|1.43|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.43|0.01|0.048
74059158|NCT00798707|147670562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.363||||0.1099|TWO_SIDED|95.0|0.93|1.99|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.99|0.93|0.1099
74059159|NCT00798707|147670562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.591||||0.0154|TWO_SIDED|95.0|1.09|2.32|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||2.32|1.09|0.0154
74059160|NCT00798707|147670563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.878||||0.5929|TWO_SIDED|95.0|0.54|1.41|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.41|0.54|0.5929
74059161|NCT00798707|147670563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.474||||0.0852|TWO_SIDED|95.0|0.95|2.29|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||2.29|0.95|0.0852
74101617|NCT02374138|147753193|SUPERIORITY|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||6 Month Follow Up||||0.53
74059162|NCT00798707|147670564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.277||||0.2232|TWO_SIDED|95.0|0.86|1.89|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.89|0.86|0.2232
74059163|NCT00798707|147670564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.827||||0.0022|TWO_SIDED|95.0|1.24|2.69|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||2.69|1.24|0.0022
74059164|NCT00798707|147670565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.158||||0.4313|TWO_SIDED|95.0|0.8|1.67|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.||1.67|0.80|0.4313
74059165|NCT00798707|147670565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.372||||0.0888|TWO_SIDED|95.0|0.95|1.97|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.||1.97|0.95|0.0888
74059166|NCT00798707|147670567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09||||0.073|TWO_SIDED|95.0|-0.1|2.29|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.||2.29|-0.10|0.073
74059167|NCT00798707|147670567|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.06||||0.078|TWO_SIDED|95.0|-0.12|2.24|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.||2.24|-0.12|0.078
74059168|NCT00798707|147670567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.176|TWO_SIDED|95.0|-0.13|0.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.||0.73|-0.13|0.176
74059169|NCT00798707|147670567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.109|TWO_SIDED|95.0|-0.08|0.77|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.||0.77|-0.08|0.109
74059170|NCT00798707|147670567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.064|TWO_SIDED|95.0|-0.02|0.84|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.||0.84|-0.02|0.064
74059171|NCT00798707|147670567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.104|TWO_SIDED|95.0|-0.07|0.78|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.||0.78|-0.07|0.104
74101618|NCT02374138|147753193|SUPERIORITY|||||||0.77||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||12 Month Follow up||||0.77
74101619|NCT02374138|147753194|SUPERIORITY|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 6 Month Follow up||||0.53
74101620|NCT02374138|147753194|SUPERIORITY|||||||0.57||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 12 Month Follow up||||0.57
74101621|NCT02374138|147753195|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74101622|NCT02374138|147753198|SUPERIORITY|||||||0.58||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on Brief COPE at 12 Months||||0.58
74101623|NCT02374138|147753200|SUPERIORITY|||||||0.46||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 6 Month Follow Up||||0.46
74059172|NCT00798707|147670567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.538|TWO_SIDED|95.0|-2.98|5.57|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score.||5.57|-2.98|0.538
74059173|NCT00798707|147670567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.689|TWO_SIDED|95.0|-1.76|2.62|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score||2.62|-1.76|0.689
74059174|NCT00798707|147670568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.066|TWO_SIDED|95.0|-1.67|0.05|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.05|-1.67|0.066
74059175|NCT00798707|147670568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.15|TWO_SIDED|95.0|-1.48|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.23|-1.48|0.150
74059176|NCT00798707|147670569|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.951||||0.8758|TWO_SIDED|95.0|0.51|1.78|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.78|0.51|0.8758
74059177|NCT00798707|147670569|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.165||||0.6397|TWO_SIDED|95.0|0.61|2.21|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||2.21|0.61|0.6397
74059178|NCT00798707|147670571|SUPERIORITY_OR_OTHER|||||||0.847|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).||||0.847
74059179|NCT00798707|147670571|SUPERIORITY_OR_OTHER|||||||0.847|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).||||0.847
74059180|NCT00798707|147670571|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).||||0.720
74101624|NCT02374138|147753200|SUPERIORITY|||||||0.62||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 12 Month Follow Up||||0.62
74101625|NCT02374138|147753202|SUPERIORITY|By repeated measures, p-value adjusted for age and gender||||||0.35|||||||Generalized Linear Model Analysis|||||||0.35
74101626|NCT02374138|147753203|SUPERIORITY|Daytime asthma symptoms in prior 14d at 6-month follow up||||||0.54|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.54
73881859|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2704|TWO_SIDED|95.0|-0.73|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.20|-0.73|0.2704
73881860|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.561|TWO_SIDED|95.0|-1.24|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||0.67|-1.24|0.5610
73881861|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.49||0.7966|TWO_SIDED|95.0|-0.83|1.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.09|-0.83|0.7966
74059181|NCT00798707|147670571|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).||||0.720
74059182|NCT00798707|147670571|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).||||0.720
74059183|NCT00798707|147670571|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).||||0.720
74059184|NCT00929201|147670586|NON_INFERIORITY_OR_EQUIVALENCE|The FMI sitagliptin/metformin 50/500 mg FDC tablet and coadministration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the AUC0-∞ for metformin \[i.e., the true metformin AUC0-∞GMR (sitagliptin/metformin 50/500 mg FDC tablet/co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)\].|Least-Squares Mean Ratio|0.97||||||90.0|0.95|1.0||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets||1.00|0.95|
74059185|NCT00929201|147670587|NON_INFERIORITY_OR_EQUIVALENCE|The FMI sitagliptin/metformin 50/500 mg FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the Cmax for metformin \[i.e., the true metformin Cmax GMR (sitagliptin/metformin 50/500 mg FDC tablet/ co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)\].|Least-Squares Mean Ratio|0.95||||||90.0|0.93|0.98||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets||0.98|0.93|
74059186|NCT02354352|147670588|NON_INFERIORITY|Using a Type I error rate of 5%, we conducted a power calculation using a non-inferiority test on 12-month change in Ecc. If there is truly no difference in the 12-month Ecc change between the spironolactone and eplerenone groups, 46 patients (23 in each group) would result in at least 80% power to ensure that the lower limit of a one-sided 95% confidence interval for the true difference between the spironolactone and eplerenone groups to be above the non-inferiority limit of -1.75.||||||0.5867|||||||Wilcoxon (Mann-Whitney)|||||||0.5867
74059187|NCT04242264|147670589|SUPERIORITY|A two-sided Chi-squared test with alpha=0.05 was used to test the null hypothesis that the vaccine efficacy is zero, which is equivalent to testing that the relative risk of shigellosis is one.|Vaccine efficacy|0.89|||<|0.001|TWO_SIDED|95.0|0.71|0.96|||Chi-squared||Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate.|The null hypothesis is that the absolute vaccine efficacy (VE) of preventing shigellosis is zero. The alternative hypothesis is that the absolute VE is greater than zero.||0.96|0.71|<0.001
74059188|NCT04242264|147670590|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|0.77|||||TWO_SIDED|95.0|0.44|0.92||||||||0.92|0.44|
73881862|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.3965|TWO_SIDED|95.0|-0.56|1.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.40|-0.56|0.3965
73881863|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8189|TWO_SIDED|95.0|-0.87|1.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.10|-0.87|0.8189
74059189|NCT04242264|147670590|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|1.0|||||TWO_SIDED|95.0|0.78|1.0||||||||1.00|0.78|
74059190|NCT04242264|147670590|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|1.0|||||TWO_SIDED|95.0|0.71|1.0||||||||1.00|0.71|
74059191|NCT00471237|147670621|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_ERROR_OF_MEAN|0.55||0.59|TWO_SIDED|95.0|-0.78|1.37|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||1.37|-0.78|0.590
74059192|NCT00471237|147670621|SUPERIORITY||Mean Difference (Net)|1.36|STANDARD_ERROR_OF_MEAN|0.55||0.028|TWO_SIDED|95.0|0.28|2.44|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12||||2.44|0.28|0.028
73881864|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5||0.5693|TWO_SIDED|95.0|-1.27|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||0.70|-1.27|0.5693
73881865|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.49||0.5217|TWO_SIDED|95.0|-1.29|0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||0.65|-1.29|0.5217
74059193|NCT00471237|147670621|SUPERIORITY||Mean Difference (Net)|1.58|STANDARD_ERROR_OF_MEAN|0.54||0.011|TWO_SIDED|95.0|0.51|2.65|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||2.65|0.51|0.011
73881866|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.49||0.2988|TWO_SIDED|95.0|-0.46|1.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.48|-0.46|0.2988
73881867|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7957|TWO_SIDED|95.0|-0.69|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.53|-0.69|0.7957
74059194|NCT00471237|147670621|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.55||0.012|TWO_SIDED|95.0|0.51|2.69|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||2.69|0.51|0.012
74059195|NCT00471237|147670629|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|0.47||0.68|TWO_SIDED|95.0|-1.38|0.48|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||0.48|-1.38|0.680
74059196|NCT00471237|147670629|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.48||0.192|TWO_SIDED|95.0|0.01|1.89|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||1.89|0.01|0.192
74059197|NCT00471237|147670629|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.47||0.68|TWO_SIDED|95.0|-1.12|0.73|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||0.73|-1.12|0.680
74059198|NCT00471237|147670629|SUPERIORITY||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.68|TWO_SIDED|95.0|-0.59|1.29|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||1.29|-0.59|0.680
74059199|NCT00471237|147670630|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.33||0.037|TWO_SIDED|95.0|-1.32|-0.04|||ANOVA|||Total Hip aBMD, Month 6||-0.04|-1.32|0.037
74059200|NCT00471237|147670630|SUPERIORITY||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.33||0.017|TWO_SIDED|95.0|-1.43|-0.14|||ANOVA|||Total Hip aBMD, Month 6||-0.14|-1.43|0.017
73881868|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.254|TWO_SIDED|95.0|-0.97|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.26|-0.97|0.2540
74059201|NCT00471237|147670630|SUPERIORITY||Mean Difference (Net)|-1.28|STANDARD_ERROR_OF_MEAN|0.32||0|TWO_SIDED|95.0|-1.92|-0.64|||ANOVA|||Total Hip aBMD, Month 6||-0.64|-1.92|0.000
74059202|NCT00471237|147670630|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.33||0|TWO_SIDED|95.0|-1.95|-0.65|||ANOVA|||Total Hip aBMD, Month 6||-0.65|-1.95|0.000
74059203|NCT00471237|147670630|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.36||0.015|TWO_SIDED|95.0|-1.61|-0.17|||ANOVA|||Total Hip aBMD, Month 12||-0.17|-1.61|0.015
74101627|NCT02374138|147753203|SUPERIORITY|Daytime Asthma Symptoms at 12 month follow up||||||0.11|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.11
74101628|NCT02374138|147753203|SUPERIORITY|Days of Activity Limitations at 6 month follow up||||||0.82|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.82
74101629|NCT02374138|147753203|SUPERIORITY|Days of Activity Limitations at 12 month follow up||||||0.84|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.84
74101630|NCT02374138|147753203|SUPERIORITY|Days of Quick Relief Medicine Use at 6 month follow up||||||0.7|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.70
74101631|NCT02374138|147753203|SUPERIORITY|Days of Quick Relief Medicine Use at 12 month follow up||||||0.58|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.58
74059204|NCT00471237|147670630|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|0.37||0.006|TWO_SIDED|95.0|-1.74|-0.3|||ANOVA|||Total Hip aBMD, Month 12||-0.30|-1.74|0.006
74101632|NCT02374138|147753204|OTHER|Univariate test||||||0.2|||||||Chi-squared|||Parent education||||0.20
74101633|NCT02374138|147753205|SUPERIORITY|||||||0.91||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS exposure at 6 Month Follow Up||||0.91
74101634|NCT02374138|147753205|SUPERIORITY|||||||0.98||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS Exposure at 12 Month Follow up||||0.98
74101635|NCT02374138|147753206|OTHER|Univariate test||||||0.94|||||||Chi-squared|||||||0.94
74101636|NCT02374138|147753207|SUPERIORITY|||||||0.02||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 6 Months||||0.02
74101637|NCT02374138|147753207|SUPERIORITY|||||||0.85||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 12 Months||||0.85
74101638|NCT02374138|147753208|OTHER|Univariate test||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
74101639|NCT04386616|147753214|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9266|TWO_SIDED|95.0|0.75|1.36||p\<0.05 threshold for statistical significance|Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.36|0.75|0.9266
74059205|NCT00471237|147670630|SUPERIORITY||Mean Difference (Net)|-1.33|STANDARD_ERROR_OF_MEAN|0.36||0|TWO_SIDED|95.0|-2.04|-0.63|||ANOVA|||Total Hip aBMD, Month 12||-0.63|-2.04|0.000
74059206|NCT00471237|147670630|SUPERIORITY||Median Difference (Net)|-1.57|STANDARD_ERROR_OF_MEAN|0.37||0|TWO_SIDED|95.0|-2.3|-0.84|||ANOVA|||Total Hip aBMD, Month 12||-0.84|-2.30|0.000
74059207|NCT01976104|147670655|SUPERIORITY||Difference of proportion versus placebo|33.7|||=|0.0006|TWO_SIDED|95.0|15.8|51.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||51.6|15.8|=0.0006
74059208|NCT01976104|147670655|SUPERIORITY||Difference of proportion versus placebo|54.6|||<|0.0001|TWO_SIDED|95.0|36.5|72.7|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||72.7|36.5|<0.0001
74059209|NCT01976104|147670656|SUPERIORITY||Difference of proportion versus placebo|60.2|||<|0.0001|TWO_SIDED|95.0|46.8|73.5|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.||73.5|46.8|<0.0001
74101640|NCT04386616|147753214|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.357|TWO_SIDED|95.0|0.86|1.54||p\<0.05 threshold for statistical significance|Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.54|0.86|0.3570
74101641|NCT04386616|147753214|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9812|TWO_SIDED|95.0|0.74|1.36||p\<0.05 threshold for statistical significance|Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.36|0.74|0.9812
74101642|NCT04386616|147753214|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5151|TWO_SIDED|95.0|0.82|1.49||p\<0.05 threshold for statistical significance|Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.49|0.82|0.5151
74059210|NCT01976104|147670656|SUPERIORITY||Difference of proportion versus placebo|53.7|||<|0.0001|TWO_SIDED|95.0|35.8|71.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||71.6|35.8|<0.0001
74059211|NCT01976104|147670657|SUPERIORITY||Difference in change of platelet count|25.4|||<|0.0001|TWO_SIDED|95.0|19.5|32.0|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from Baseline of platelet count for avatrombopag versus placebo within each Baseline platelet count cohort was based on Hodges-Lehmann estimation; 95% CI was the asymptotic (Moses) CI|||32.0|19.5|<0.0001
74059212|NCT01976104|147670657|SUPERIORITY||Difference in change of platelet count|36.3|||<|0.0001|TWO_SIDED|95.0|25.5|45.5|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs. placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||45.5|25.5|<0.0001
74059213|NCT01353209|147670665|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.4
74059214|NCT01353209|147670666|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.7
74059215|NCT01353209|147670667|SUPERIORITY|||||||0.8|||||||Regression, Linear|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.8
74059216|NCT01353209|147670667|SUPERIORITY|||||||0.8|||||||Regression, Linear|||||||.8
74059217|NCT01353209|147670668|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use. P value was obtained for testing zero slope for log(VEGF-D).||||||0.015
74059218|NCT03112720|147670671|OTHER||Odds Ratio (OR)|1.5|||<|0.01|TWO_SIDED||||||Chi-squared||||\< 0.01 study terminated because of covid and no meaningfull numbers participated|||<0.01
74059219|NCT03237325|147670759|SUPERIORITY|||||||0.1798|||||||Log Rank|||||||0.1798
74059220|NCT02684370|147670763|OTHER||adjusted difference in percentage|70.3|||<|0.001|TWO_SIDED|95.0|64.0|76.7||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||76.7|64.0|<0.001
74059221|NCT02684370|147670764|OTHER||adjusted difference in percentage|79.9|||<|0.001|TWO_SIDED|95.0|73.5|86.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||86.3|73.5|<0.001
74059222|NCT02684370|147670765|OTHER||adjusted difference in percentage|34.7|||<|0.001|TWO_SIDED|95.0|28.6|40.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.8|28.6|<0.001
74059223|NCT02684370|147670766|OTHER||adjusted difference in percentage|35.5|||<|0.001|TWO_SIDED|95.0|30.0|41.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||41.0|30.0|< 0.001
74059224|NCT02684370|147670767|OTHER||adjusted difference in percentage|57.9|||<|0.001|TWO_SIDED|95.0|50.4|65.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||65.3|50.4|< 0.001
74059225|NCT02684370|147670768|OTHER||adjusted difference in percentage|27.1|||<|0.001|TWO_SIDED|95.0|21.2|32.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.9|21.2|< 0.001
74059226|NCT02684370|147670769|OTHER||adjusted difference in percentage|33.5|||<|0.001|TWO_SIDED|95.0|22.7|44.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||44.3|22.7|< 0.001
74059227|NCT02684370|147670770|OTHER||adjusted difference in percentage|25.1|||<|0.001|TWO_SIDED|95.0|15.2|35.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||35.0|15.2|< 0.001
74059228|NCT02684370|147670771|OTHER||adjusted difference in percentage|23.8|||<|0.001|TWO_SIDED|95.0|15.5|32.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.1|15.5|< 0.001
74101643|NCT04386616|147753215|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8373|TWO_SIDED|95.0|0.77|1.39|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.39|0.77|0.8373
74101644|NCT04386616|147753215|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3396|TWO_SIDED|95.0|0.86|1.55|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.55|0.86|0.3396
74101645|NCT04386616|147753215|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8619|TWO_SIDED|95.0|0.76|1.39|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.39|0.76|0.8619
74101646|NCT04386616|147753215|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.4913|TWO_SIDED|95.0|0.82|1.5|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.50|0.82|0.4913
74101647|NCT04386616|147753216|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.4711|TWO_SIDED|95.0|0.83|1.49|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.49|0.83|0.4711
74101648|NCT04386616|147753216|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.3135|TWO_SIDED|95.0|0.87|1.56|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.56|0.87|0.3135
74059229|NCT02684370|147670772|OTHER||adjusted difference in percentage|22.9|||<|0.001|TWO_SIDED|95.0|14.3|31.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||31.6|14.3|< 0.001
74059230|NCT02684370|147670773|OTHER||adjusted difference in percentage|38.3|||<|0.001|TWO_SIDED|95.0|27.9|48.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||48.6|27.9|< 0.001
74101649|NCT04386616|147753216|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.5735|TWO_SIDED|95.0|0.81|1.48|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.48|0.81|0.5735
73881869|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.6956|TWO_SIDED|95.0|-0.75|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.50|-0.75|0.6956
74101650|NCT04386616|147753216|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5973|TWO_SIDED|95.0|0.8|1.46|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.46|0.80|0.5973
74101651|NCT04386616|147753217|SUPERIORITY||Median Difference (Net)|-1.0||||0.5304|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.5304
74101652|NCT04386616|147753217|SUPERIORITY||Median Difference (Net)|-4.5||||0.5058|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.5058
74101653|NCT04386616|147753218|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8451|TWO_SIDED|95.0|0.64|1.72|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.72|0.64|0.8451
74101654|NCT04386616|147753218|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7267|TWO_SIDED|95.0|0.67|1.79|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.79|0.67|0.7267
74101655|NCT04386616|147753218|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8458|TWO_SIDED|95.0|0.63|1.79|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.79|0.63|0.8458
74101656|NCT04386616|147753218|SUPERIORITY||Odds Ratio (OR)|1.08||||0.7907|TWO_SIDED|95.0|0.64|1.81|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.81|0.64|0.7907
74101657|NCT04386616|147753219|SUPERIORITY||Median Difference (Final Values)|0.0||||0.5273|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.5273
74101658|NCT04386616|147753219|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6515|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.6515
74101659|NCT04386616|147753219|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5475|TWO_SIDED|95.0|0.71|1.91|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.91|0.71|0.5475
74101660|NCT04386616|147753219|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5652|TWO_SIDED|95.0|0.71|1.89|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.89|0.71|0.5652
74101661|NCT04386616|147753220|SUPERIORITY||Median Difference (Final Values)|0.0||||0.3401|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.3401
74101662|NCT04386616|147753220|SUPERIORITY||Median Difference (Final Values)|0.0||||0.4676|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.4676
74101663|NCT04386616|147753220|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3408|TWO_SIDED|95.0|0.75|2.29|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.29|0.75|0.3408
74101664|NCT04386616|147753220|SUPERIORITY||Odds Ratio (OR)|1.32||||0.332|TWO_SIDED|95.0|0.76|2.29|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.29|0.76|0.3320
74101665|NCT04386616|147753221|SUPERIORITY||Difference in percentage of participants|3.83|||||TWO_SIDED|95.0|-7.57|15.24|||||The difference in percentage of participants was calculated as the MSTT1041A Arm minus the Placebo Arm.|||15.24|-7.57|
74101666|NCT04386616|147753221|SUPERIORITY||Difference in percentage of participants|-0.38|||||TWO_SIDED|95.0|-11.46|10.7|||||The difference in percentage of participants was calculated as the UTTR1147A Arm minus the Placebo Arm.|||10.70|-11.46|
74101667|NCT04386616|147753221|SUPERIORITY||Odds Ratio (OR)|1.22||||0.4804|TWO_SIDED|95.0|0.7|2.1|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.10|0.70|0.4804
74101668|NCT04386616|147753221|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9418|TWO_SIDED|95.0|0.56|1.71|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.71|0.56|0.9418
74101669|NCT04386616|147753221|SUPERIORITY||Odds Ratio (OR)|1.29||||0.4988|TWO_SIDED|95.0|0.68|2.44|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.44|0.68|0.4988
74059231|NCT02684370|147670774|OTHER||adjusted difference in percentage|35.1|||<|0.001|TWO_SIDED|95.0|25.7|44.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||44.6|25.7|< 0.001
74059232|NCT02684370|147670775|OTHER||adjusted difference in percentage|36.5|||<|0.001|TWO_SIDED|95.0|27.0|45.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||45.9|27.0|< 0.001
74059233|NCT02684370|147670776|OTHER||adjusted difference in percentage|17.0|||<|0.001|TWO_SIDED|95.0|7.4|26.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||26.6|7.4|< 0.001
74059234|NCT02684370|147670777|OTHER||adjusted difference in percentage|17.3|||<|0.001|TWO_SIDED|95.0|7.3|27.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||27.3|7.3|< 0.001
74059235|NCT02684370|147670778|OTHER||adjusted difference in percentage|23.0|||<|0.001|TWO_SIDED|95.0|11.9|34.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||34.0|11.9|< 0.001
74059236|NCT02684370|147670779|OTHER||Mean Difference (Final Values)|-5.765|||<|0.001|TWO_SIDED|95.0|-6.496|-5.035|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||-5.035|-6.496|<0.001
74059237|NCT04221373|147670780|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 117.78||SCIM Total Score||||<0.01
74059238|NCT04221373|147670780|OTHER|Mixed-effects model||||||0.03||||||treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 5.59||SCIM Total Score||||0.03
74059239|NCT04221373|147670780|OTHER|Mixed-effects model||||||0.01||||||treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 8.02||SCIM R \& S scores||||0.01
74059240|NCT04221373|147670780|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 72.49||SCIM R \& S scores||||< 0.01
74059241|NCT04221373|147670781|OTHER|Mixed-effects model||||||0.02||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 5.82||LEMS||||0.02
74059242|NCT04221373|147670781|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 33.29||LEMS||||<0.01
74059243|NCT04221373|147670781|OTHER|Mixed-effects model||||||0.04||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 4.58||UEMS||||0.04
74059244|NCT04221373|147670781|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 15.34||UEMS||||<0.01
74059245|NCT04221373|147670781|OTHER|Mixed-effects model|||||<|0.01||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 8.06||TMS||||<0.01
74059246|NCT04221373|147670781|OTHER|TMS|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1,26) = 38.91||||||<0.01
74059247|NCT04221373|147670781|OTHER|Mixed-effects model||||||0.02||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,21.7) = 6.23||TLTS||||0.02
74059248|NCT04221373|147670781|OTHER|Mixed-effects model||||||0.05||||||Main effect of time|Mixed Models Analysis|F(1 26)=4.14||TLTS||||0.05
74059249|NCT04221373|147670782|OTHER|Mixed-effects model||||||0.485||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 21) = 0.51||Average worst pain intensity||||0.485
74059250|NCT04221373|147670782|OTHER|Mixed-effects model||||||0||||||Main effect of time|Mixed Models Analysis|F(1, 21) = 26.71||Average worst pain intensity||||0.000
74059251|NCT04221373|147670782|OTHER|Mixed-effects model||||||0.832||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 21) = 0.05||Worst pain interference with day-to-day activities||||0.832
74059252|NCT04221373|147670782|OTHER|Mixed-effects model||||||0.033||||||Main effect of time|Mixed Models Analysis|F(1, 21) = 5.21||Worst pain interference with day-to-day activities||||0.033
74059253|NCT04221373|147670782|OTHER|Mixed-effects model||||||0.692||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 42) = 0.16||Worst pain interference with overall mood||||0.692
74059254|NCT04221373|147670782|OTHER|Mixed-effects model||||||0.005||||||Main effect of time|Mixed Models Analysis|F(1, 42) = 8.65||Worst pain interference with overall mood||||0.005
74059255|NCT04221373|147670782|OTHER|Mixed-effects model||||||0.946||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1,21) = 0.01||Worst pain interfered with sleep||||0.946
74059256|NCT04221373|147670782|OTHER|Mixed-effects model||||||0.0002||||||Main effect of time|Mixed Models Analysis|F(1,21) = 11.94||Worst pain interference with sleep||||0.0002
74059257|NCT04221373|147670783|SUPERIORITY|||||||0.554|||||||Chi-squared|X\^2 (1, N = 23) = 0.35||Baseline||||0.554
74059258|NCT04221373|147670783|SUPERIORITY|||||||0.949|||||||Chi-squared|X\^2 (1, N = 23) = 0.004||discharge from acute inpatient rehabilitation (average 2-3 weeks)||||0.949
74059259|NCT01354015|147670805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|0.79||0.2539|TWO_SIDED|95.0|||||ANOVA|||All statistical analysis used intent-to-treat methodology and all comparisons used a two-tailed test at the .05 level of significance. Continuous variables are reported as means and standard deviations. W||||0.2539
74059260|NCT03733301|147670807|SUPERIORITY||Odds Ratio (OR)|1.88||||0.082|TWO_SIDED|95.0|0.92|3.85|||Regression, Logistic|||||3.85|0.92|0.082
74059261|NCT03733301|147670807|SUPERIORITY||Odds Ratio (OR)|2.77||||0.004|TWO_SIDED|95.0|1.38|5.56|||Regression, Logistic|||||5.56|1.38|0.004
74059262|NCT03733301|147670808|SUPERIORITY||Odds Ratio (OR)|2.62||||0.002|TWO_SIDED|95.0|1.44|4.76|||Regression, Logistic|||||4.76|1.44|0.002
74059263|NCT03733301|147670808|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.8|5.97|||Regression, Logistic|||||5.97|1.80|< 0.001
74059264|NCT03733301|147670809|SUPERIORITY||Odds Ratio (OR)|1.24||||0.574|TWO_SIDED|95.0|0.59|2.62|||Regression, Logistic|||||2.62|0.59|0.574
74059265|NCT03733301|147670809|SUPERIORITY||Odds Ratio (OR)|2.07||||0.045|TWO_SIDED|95.0|1.02|4.2|||Regression, Logistic|||||4.20|1.02|0.045
74059266|NCT03733301|147670810|SUPERIORITY||Mean Difference (Final Values)|-13.08|STANDARD_ERROR_OF_MEAN|5.256||0.013|TWO_SIDED|95.0|-23.42|-2.73|||Mixed Models Analysis|||||-2.73|-23.42|0.013
74059267|NCT03733301|147670810|SUPERIORITY||Mean Difference (Final Values)|-22.13|STANDARD_ERROR_OF_MEAN|5.259|<|0.001|TWO_SIDED|95.0|-32.48|-11.78|||Mixed Models Analysis|||||-11.78|-32.48|<0.001
74059268|NCT03733301|147670811|SUPERIORITY||Odds Ratio (OR)|1.53||||0.364|TWO_SIDED|95.0|0.61|3.81|||Regression, Logistic|||||3.81|0.61|0.364
74059269|NCT03733301|147670811|SUPERIORITY||Odds Ratio (OR)|2.7||||0.022|TWO_SIDED|95.0|1.15|6.34|||Regression, Logistic|||||6.34|1.15|0.022
74059270|NCT03733301|147670812|SUPERIORITY||Odds Ratio (OR)|2.88||||0.002|TWO_SIDED|95.0|1.48|5.61|||Regression, Logistic|||||5.61|1.48|0.002
74059271|NCT03733301|147670812|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|1.98|7.46|||Regression, Logistic|||||7.46|1.98|<0.001
74059272|NCT03733301|147670813|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.23|-0.41|||Mixed Models Analysis|||||-0.41|-1.23|<0.001
74059273|NCT03733301|147670813|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.33|-0.51|||Mixed Models Analysis|||||-0.51|-1.33|<0.001
74059274|NCT03733301|147670814|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.319|<|0.001|TWO_SIDED|95.0|-1.78|-0.52|||Mixed Models Analysis|||||-0.52|-1.78|<0.001
74059275|NCT03733301|147670814|SUPERIORITY||Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-2.3|-1.3|||Mixed Models Analysis|||||-1.30|-2.30|<0.001
74059276|NCT03733301|147670815|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.001|TWO_SIDED|95.0|1.47|4.49|||Regression, Logistic|||||4.49|1.47|<0.001
74059277|NCT03733301|147670815|SUPERIORITY||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|2.0|6.32|||Regression, Logistic|||||6.32|2.00|<0.001
74059278|NCT03733301|147670816|SUPERIORITY||Odds Ratio (OR)|1.3||||0.715|TWO_SIDED|95.0|0.32|5.31|||Regression, Logistic|||||5.31|0.32|0.715
74059279|NCT03733301|147670816|SUPERIORITY||Odds Ratio (OR)|3.02||||0.083|TWO_SIDED|95.0|0.86|10.56|||Regression, Logistic|||||10.56|0.86|0.083
74059280|NCT03733301|147670817|SUPERIORITY||Mean Difference (Final Values)|-8.48|STANDARD_ERROR_OF_MEAN|2.663||0.002|TWO_SIDED|95.0|-13.72|-3.24|||Mixed Models Analysis|||||-3.24|-13.72|0.002
74059281|NCT03733301|147670817|SUPERIORITY||Mean Difference (Final Values)|-14.38|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|-19.62|-9.14|||Mixed Models Analysis|||||-9.14|-19.62|<0.001
74059282|NCT03733301|147670818|SUPERIORITY||Odds Ratio (OR)|3.21||||0.204|TWO_SIDED|95.0|0.53|19.37|||Regression, Logistic|||||19.37|0.53|0.204
74059283|NCT03733301|147670818|SUPERIORITY||Odds Ratio (OR)|6.99||||0.025|TWO_SIDED|95.0|1.27|38.53|||Regression, Logistic|||||38.53|1.27|0.025
74059284|NCT03733301|147670819|SUPERIORITY||Mean Difference (Final Values)|-8.97|STANDARD_ERROR_OF_MEAN|2.591|<|0.001|TWO_SIDED|95.0|-14.07|-3.87|||Mixed Models Analysis|||||-3.87|-14.07|<0.001
74059285|NCT03733301|147670819|SUPERIORITY||Mean Difference (Final Values)|-11.69|STANDARD_ERROR_OF_MEAN|2.584|<|0.001|TWO_SIDED|95.0|-16.78|-6.61|||Mixed Models Analysis|||||-6.61|-16.78|<0.001
74059286|NCT03733301|147670820|SUPERIORITY|||||||0.721|||||||Fisher Exact|||||||0.721
74059287|NCT03733301|147670820|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
74059288|NCT03733301|147670821|SUPERIORITY||Mean Difference (Final Values)|-65.16|STANDARD_ERROR_OF_MEAN|24.149||0.0073|TWO_SIDED|95.0|-112.87|-17.65|||ANOVA|||||-17.65|-112.87|0.0073
74059289|NCT03733301|147670821|SUPERIORITY||Mean Difference (Final Values)|-91.14|STANDARD_ERROR_OF_MEAN|24.038||0.0002|TWO_SIDED|95.0|-138.43|-43.85|||ANOVA|||||-43.85|-138.43|0.0002
74059290|NCT03733301|147670822|SUPERIORITY||Mean Difference (Final Values)|-16.44|STANDARD_ERROR_OF_MEAN|4.658|<|0.001|TWO_SIDED|95.0|-25.6|-7.27|||Mixed Models Analysis|||||-7.27|-25.60|< 0.001
74059291|NCT03733301|147670822|SUPERIORITY||Mean Difference (Final Values)|-24.22|STANDARD_ERROR_OF_MEAN|4.672|<|0.001|TWO_SIDED|95.0|-33.42|-15.03|||Mixed Models Analysis|||||-15.03|-33.42|< 0.001
74101670|NCT04386616|147753221|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9043|TWO_SIDED|95.0|0.54|1.96|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.96|0.54|0.9043
74101671|NCT04386616|147753222|SUPERIORITY||Median Difference (Net)|0.0||||0.8007|||||||Van Elteren||Median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.8007
74101672|NCT04386616|147753222|SUPERIORITY||Median Difference (Net)|0.0||||0.8633|||||||Van Elteren||Median difference was calculated as the UTTR1147A Arm minus the Placebo Arm.|||||0.8633
74101673|NCT04386616|147753223|SUPERIORITY||Difference in percentage of participants|-3.59|||||TWO_SIDED|95.0|-16.31|9.12|||||The difference in percentage of participants was calculated as the MSTT1041A Arm minus the Placebo Arm.|||9.12|-16.31|
74101674|NCT04386616|147753223|SUPERIORITY||Difference in percentage of participants|-12.0|||||TWO_SIDED|95.0|-24.67|0.67|||||The difference in percentage of participants was calculated as the UTTR1147A Arm minus the Placebo Arm.|||0.67|-24.67|
74101675|NCT04386616|147753223|SUPERIORITY||Odds Ratio (OR)|0.86||||0.556|TWO_SIDED|95.0|0.53|1.41|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.41|0.53|0.5560
74101676|NCT04386616|147753223|SUPERIORITY||Odds Ratio (OR)|0.62||||0.0502|TWO_SIDED|95.0|0.38|1.0|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.00|0.38|0.0502
74101677|NCT04386616|147753223|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7002|TWO_SIDED|95.0|0.51|1.6|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.60|0.51|0.7002
74101678|NCT04386616|147753223|SUPERIORITY||Odds Ratio (OR)|0.57||||0.0448|TWO_SIDED|95.0|0.32|0.99|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||0.99|0.32|0.0448
74101679|NCT04386616|147753224|SUPERIORITY||Median Difference (Net)|-0.48||||0.4845|||||||Van Elteren||Median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.4845
74101680|NCT04386616|147753224|SUPERIORITY||Median Difference (Net)|-3.1||||0.057|||||||Van Elteren||Median difference was calculated as the UTTR1147A Arm minus the Placebo Arm.|||||0.0570
74101681|NCT04386616|147753225|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.4456|TWO_SIDED|95.0|0.76|1.88|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.88|0.76|0.4456
74101682|NCT04386616|147753225|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7213|TWO_SIDED|95.0|0.57|1.48|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.48|0.57|0.7213
74101683|NCT04386616|147753225|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.3963|TWO_SIDED|95.0|0.77|1.96|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.96|0.77|0.3963
74101684|NCT04386616|147753225|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9174|TWO_SIDED|95.0|0.6|1.58|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.58|0.60|0.9174
74101685|NCT04386616|147753226|OTHER||Difference in Mortality Rates|2.49|||||TWO_SIDED|95.0|-4.51|9.49|||||The difference in mortality rates is calculated as the MSTT1041A Arm minus the Placebo Arm.|||9.49|-4.51|
74101686|NCT04386616|147753226|OTHER||Difference in Mortality Rates|2.36|||||TWO_SIDED|95.0|-4.58|9.31|||||The difference in mortality rates is calculated as the UTTR1147A Arm minus the Placebo Arm.|||9.31|-4.58|
74101687|NCT04386616|147753226|SUPERIORITY||Odds Ratio (OR)|1.46||||0.4336|TWO_SIDED|95.0|0.57|3.74|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||3.74|0.57|0.4336
74101688|NCT04386616|147753226|SUPERIORITY||Odds Ratio (OR)|1.43||||0.4543|TWO_SIDED|95.0|0.56|3.68|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||3.68|0.56|0.4543
74101689|NCT04386616|147753226|SUPERIORITY||Odds Ratio (OR)|1.46||||0.49|TWO_SIDED|95.0|0.54|3.97|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||3.97|0.54|0.4900
74101690|NCT04386616|147753226|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3595|TWO_SIDED|95.0|0.58|4.28|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||4.28|0.58|0.3595
74101691|NCT04386616|147753227|OTHER||Difference in Mortality Rates|3.42|||||TWO_SIDED|95.0|-5.42|12.26|||||The difference in mortality rates is calculated as the MSTT1041A Arm minus the Placebo Arm.|||12.26|-5.42|
74059292|NCT03733301|147670823|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.046||0.006|TWO_SIDED|95.0|-4.96|-0.84|||Mixed Models Analysis|||||-0.84|-4.96|0.006
74059293|NCT03733301|147670823|SUPERIORITY||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|1.043|<|0.001|TWO_SIDED|95.0|-7.28|-3.18|||Mixed Models Analysis|||||-3.18|-7.28|< 0.001
74101692|NCT04386616|147753227|OTHER||Difference in Mortality Rates|1.68|||||TWO_SIDED|95.0|-6.89|10.26|||||The difference in mortality rates is calculated as the UTTR1147A Arm minus the Placebo Arm.|||10.26|-6.89|
74101693|NCT04386616|147753227|SUPERIORITY||Odds Ratio (OR)|1.36||||0.4067|TWO_SIDED|95.0|0.66|2.8|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.80|0.66|0.4067
74101694|NCT04386616|147753227|SUPERIORITY||Odds Ratio (OR)|1.17||||0.6728|TWO_SIDED|95.0|0.56|2.46|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.46|0.56|0.6728
74101695|NCT04386616|147753227|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5495|TWO_SIDED|95.0|0.62|2.87|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.87|0.62|0.5495
73881870|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.32||0.8694|TWO_SIDED|95.0|-0.57|0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.68|-0.57|0.8694
73881871|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32||0.5047|TWO_SIDED|95.0|-0.84|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.41|-0.84|0.5047
73881872|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7515|TWO_SIDED|95.0|-0.52|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.71|-0.52|0.7515
73881873|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7818|TWO_SIDED|95.0|-0.7|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.53|-0.70|0.7818
74101696|NCT04386616|147753227|SUPERIORITY||Odds Ratio (OR)|1.24||||0.5551|TWO_SIDED|95.0|0.57|2.71|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.71|0.57|0.5551
74101697|NCT04386616|147753228|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.3831|TWO_SIDED|95.0|0.71|2.4|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.40|0.71|0.3831
74101698|NCT04386616|147753228|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5925|TWO_SIDED|95.0|0.65|2.15|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.15|0.65|0.5925
74101699|NCT04386616|147753228|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.7487|TWO_SIDED|95.0|0.6|2.05|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.05|0.60|0.7487
74101700|NCT04386616|147753228|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.6092|TWO_SIDED|95.0|0.63|2.21|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.21|0.63|0.6092
74101701|NCT00993421|147753240|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
74101702|NCT00993421|147753240|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
74101703|NCT00993421|147753240|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
74101704|NCT00993421|147753240|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
74101705|NCT00993421|147753240|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.041
74101706|NCT00993421|147753240|SUPERIORITY_OR_OTHER|||||||0.668||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.668
74101707|NCT00993421|147753240|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.437
74101708|NCT00993421|147753240|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.249
74101709|NCT00352417|147753269|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|Satterthwaite's method||||||0.97
74101710|NCT00352417|147753270|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|Satterthwaite's method||||||0.37
74101711|NCT00352417|147753271|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73881874|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.577|TWO_SIDED|95.0|-0.65|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.36|-0.65|0.5770
74059294|NCT03733301|147670824|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.005|TWO_SIDED|95.0|-0.63|-0.12|||Mixed Models Analysis|||||-0.12|-0.63|0.005
74101712|NCT00352417|147753272|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|ANCOVA was performed on the natural log transformed data||||||<0.01
74059295|NCT03733301|147670824|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.75|-0.24|||Mixed Models Analysis|||||-0.24|-0.75|< 0.001
74059296|NCT03733301|147670825|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.425||0.083|TWO_SIDED|95.0|-1.57|0.1|||Mixed Models Analysis|||HADS Depression||0.10|-1.57|0.083
74059297|NCT03733301|147670825|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.423||0.016|TWO_SIDED|95.0|-1.85|-0.19|||Mixed Models Analysis|||HADS Depression||-0.19|-1.85|0.016
74059298|NCT03733301|147670825|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.415||0.051|TWO_SIDED|95.0|-1.63|0.0|||Mixed Models Analysis|||HADS Anxiety||0.00|-1.63|0.051
74059299|NCT03733301|147670825|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.413||0.028|TWO_SIDED|95.0|-1.72|-0.1|||Mixed Models Analysis|||HADS Anxiety||-0.10|-1.72|0.028
74059300|NCT03733301|147670826|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.832||0.022|TWO_SIDED|95.0|-3.56|-0.28|||Mixed Models Analysis|||||-0.28|-3.56|0.022
74059301|NCT03733301|147670826|SUPERIORITY||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|0.829|<|0.001|TWO_SIDED|95.0|-4.94|-1.68|||Mixed Models Analysis|||||-1.68|-4.94|< 0.001
74059302|NCT03733301|147670827|SUPERIORITY||Mean Difference (Final Values)|2.01|STANDARD_ERROR_OF_MEAN|2.569||0.435|TWO_SIDED|95.0|-3.06|7.08|||Mixed Models Analysis|||Absenteeism||7.08|-3.06|0.435
74101713|NCT00352417|147753273|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
74101714|NCT03631199|147753319|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.62||||0.00164|TWO_SIDED|95.0|0.45|0.86|||Log Rank|||Chest pain||0.86|0.45|0.00164
73881875|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.1893|TWO_SIDED|95.0|-0.85|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.17|-0.85|0.1893
74059303|NCT03733301|147670827|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.569||0.706|TWO_SIDED|95.0|-4.1|6.04|||Mixed Models Analysis|||Absenteeism||6.04|-4.10|0.706
74059304|NCT03733301|147670827|SUPERIORITY|Presenteeism|Mean Difference (Final Values)|-8.12|STANDARD_ERROR_OF_MEAN|4.384||0.066|TWO_SIDED|95.0|-16.78|0.54|||Mixed Models Analysis|||||0.54|-16.78|0.066
74059305|NCT03733301|147670827|SUPERIORITY||Mean Difference (Final Values)|-10.73|STANDARD_ERROR_OF_MEAN|4.336||0.014|TWO_SIDED|95.0|-19.3|-2.17|||Mixed Models Analysis|||Presenteeism||-2.17|-19.30|0.014
74059306|NCT03733301|147670827|SUPERIORITY|Work Productivity Loss|Mean Difference (Final Values)|-7.93|STANDARD_ERROR_OF_MEAN|4.511||0.081|TWO_SIDED|95.0|-16.84|0.99|||Mixed Models Analysis|||||0.99|-16.84|0.081
74059307|NCT03733301|147670827|SUPERIORITY||Mean Difference (Final Values)|-10.71|STANDARD_ERROR_OF_MEAN|4.473||0.018|TWO_SIDED|95.0|-19.55|1.88|||Mixed Models Analysis|||Work productivity Loss||1.88|-19.55|0.018
74059308|NCT03733301|147670827|SUPERIORITY||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|3.511||0.006|TWO_SIDED|95.0|-16.71|-2.89|||Mixed Models Analysis|||Activity Impairment||-2.89|-16.71|0.006
74059309|NCT03733301|147670827|SUPERIORITY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|3.5||0.003|TWO_SIDED|95.0|-17.39|-3.61|||Mixed Models Analysis|||Activity Impairment||-3.61|-17.39|0.003
74059310|NCT03733301|147670828|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.176|TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis|||Health State Index US||0.06|-0.01|0.176
74059311|NCT03733301|147670828|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.017||0.004|TWO_SIDED|95.0|0.02|0.09|||Mixed Models Analysis|||Health State Index US||0.09|0.02|0.004
74059312|NCT03733301|147670828|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.024||0.176|TWO_SIDED|95.0|-0.01|0.08|||Mixed Models Analysis|||Health State Index UK||0.08|-0.01|0.176
74059313|NCT03733301|147670828|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.024||0.003|TWO_SIDED|95.0|0.02|0.12|||Mixed Models Analysis|||Health State Index UK||0.12|0.02|0.003
74059314|NCT03733301|147670829|SUPERIORITY||Mean Difference (Final Values)|4.12|STANDARD_ERROR_OF_MEAN|2.593||0.113|TWO_SIDED|95.0|-0.98|9.23|||Mixed Models Analysis|||||9.23|-0.98|0.113
74059315|NCT03733301|147670829|SUPERIORITY||Mean Difference (Final Values)|6.06|STANDARD_ERROR_OF_MEAN|2.592||0.02|TWO_SIDED|95.0|0.96|11.16|||Mixed Models Analysis|||||11.16|0.96|0.020
74059316|NCT03733301|147670830|SUPERIORITY||Mean Difference (Final Values)|10.04|STANDARD_ERROR_OF_MEAN|4.36||0.022|TWO_SIDED|95.0|1.46|18.36|||ANCOVA|||||18.36|1.46|0.022
74059317|NCT03733301|147670830|SUPERIORITY||Mean Difference (Final Values)|17.33|STANDARD_ERROR_OF_MEAN|4.34|<|0.001|TWO_SIDED|95.0|8.79|25.88|||ANCOVA|||||25.88|8.79|< 0.001
74101715|NCT03631199|147753319|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.59||||0.00069|TWO_SIDED|95.0|0.43|0.82|||Log Rank|||Cough||0.82|0.43|0.00069
74101716|NCT03631199|147753319|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.66||||0.00045|TWO_SIDED|95.0|0.51|0.84|||Log Rank|||Dyspnea||0.84|0.51|0.00045
74101717|NCT03631199|147753320|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.86||||0.113|TWO_SIDED|95.0|0.66|1.1|||Log Rank|||Quality of Life||1.10|0.66|0.113
74101718|NCT03631199|147753320|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.68||||0.00433|TWO_SIDED|95.0|0.51|0.91|||Log Rank|||Shortness of Breath||0.91|0.51|0.00433
74101719|NCT03631199|147753320|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.93||||0.294|TWO_SIDED|95.0|0.72|1.2|||Log Rank|||Pain||1.20|0.72|0.294
74101720|NCT01272037|147753346|OTHER||Hazard Ratio (HR)|1.02||||0.35|TWO_SIDED|95.0|0.98|1.05|||Regression, Cox|A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*recurrence score interaction term.||This test describes the interaction of the treatment arm with the recurrence score in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on the recurrence score. If the interaction was statistically significant, the interaction term was planned to be included in the Cox model to evaluate the invasive disease-free survival outcome.||1.05|0.98|0.35
74101721|NCT01272037|147753346|OTHER||Hazard Ratio (HR)|1.71||||0.008|TWO_SIDED|95.0|1.15|2.54|||Regression, Cox|A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*menopausal status interaction term.||This test describes the interaction of the treatment arm with menopausal status (one of the study stratification factors) in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on menopausal status. If the interaction was statistically significant, separate analyses of IDFS were planned to be conducted by menopausal status.||2.54|1.15|0.008
74059318|NCT03733301|147670831|SUPERIORITY||Odds Ratio (OR)|3.83||||0.006|TWO_SIDED|95.0|1.46|10.03|||Regression, Logistic|||||10.03|1.46|0.006
74059319|NCT03733301|147670831|SUPERIORITY||Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.77|11.87|||Regression, Logistic|||||11.87|1.77|0.002
74059320|NCT00337727|147670841|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic|||||||<0.01
74059321|NCT00337727|147670842|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic|||||||<0.01
74059322|NCT00577031|147670859|SUPERIORITY_OR_OTHER|||||||0.0076|||||||Signed-rank test|||Change from baseline to last visit||||0.0076
74059323|NCT06067191|147670860|OTHER||Difference in Least Square Mean|-312.28||||0.0009|TWO_SIDED|95.0|-489.17|-135.38|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-135.38|-489.17|0.0009
74059324|NCT06067191|147670861|OTHER||Difference in Least Square Mean|-1.45||||0.0047|TWO_SIDED|95.0|-2.43|-0.47|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-0.47|-2.43|0.0047
74101722|NCT01272037|147753346|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.002|TWO_SIDED|95.0|0.43|0.83|||Regression, Cox||To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only premenopausal participants.||0.83|0.43|0.002
74101723|NCT01272037|147753346|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.89|TWO_SIDED|95.0|0.82|1.26|||Regression, Cox||To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only postmenopausal participants.||1.26|0.82|0.89
74101724|NCT01272037|147753353|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.009|TWO_SIDED|95.0|0.39|0.87|||Regression, Cox|||This analysis includes only premenopausal participants.|To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|0.87|0.39|0.009
74059325|NCT06067191|147670862|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74059326|NCT06067191|147670863|OTHER|||||||0.0051|||||||Log Rank|||||||0.0051
74101725|NCT01272037|147753353|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7|TWO_SIDED|95.0|0.81|1.37|||Regression, Cox||To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only postmenopausal participants.||1.37|0.81|0.70
74059327|NCT06067191|147670864|OTHER|||||||0.0077|||||||Log Rank|||||||0.0077
74059328|NCT06067191|147670865|OTHER||Difference in Least Square Mean|-87.4||||0.0268|TWO_SIDED|95.0|-164.3|-10.49|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-10.49|-164.30|0.0268
74059329|NCT06067191|147670866|OTHER||Difference in Least Square Mean|-0.99||||0.0865|TWO_SIDED|95.0|-2.13|0.15|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||0.15|-2.13|0.0865
74059330|NCT06067191|147670867|OTHER|||||||0.0008|||||||Log Rank|||||||0.0008
74059331|NCT06067191|147670868|OTHER|||||||0.8579|||||||Log Rank|||||||0.8579
74059332|NCT06067191|147670869|OTHER||Difference in Least Square Mean|-93.95||||0.0658|TWO_SIDED|95.0|-194.26|6.36|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||6.36|-194.26|0.0658
74059333|NCT06067191|147670870|OTHER||Difference in Least Square Mean|-93.95||||0.0658|TWO_SIDED|95.0|-194.26|6.36|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||6.36|-194.26|0.0658
74059334|NCT06067191|147670871|OTHER||Difference in Least Square Mean|-0.93||||0.203|TWO_SIDED|95.0|-2.38|0.52|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||0.52|-2.38|0.2030
74059335|NCT04764669|147670890|SUPERIORITY|Primary comparisons were: DLB without amyloid copathology versus DLB with amyloid copathology|Least squares mean difference|-20.022|||||TWO_SIDED|95.0|-77.635|37.591||||||||37.591|-77.635|
74059336|NCT04764669|147670890|SUPERIORITY|Primary comparisons were: PDD without amyloid copathology versus PDD with amyloid copathology.|Least squares mean difference|-175.65|||||TWO_SIDED|95.0|-287.407|-63.893||||||||-63.893|-287.407|
74101726|NCT03698019|147753363|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.004|TWO_SIDED||||||Log Rank|||||||0.004
74101727|NCT00588770|147753368|SUPERIORITY|||||||0.22||||||The P value was based on stratified log rank test, stratified by choice of chemotherapy combination, performance status, weight loss in the last 6 months, and prior radiation of the head and neck.|Log Rank|||The study hypothesis is that the addition of bevacizumab will improve the median survival by 35% from 8.5 months (based on E1395 and E5397) to 11.5 months.||||0.22
73881876|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2997|TWO_SIDED|95.0|-0.25|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.79|-0.25|0.2997
74101728|NCT01856192|147753373|SUPERIORITY|||||||0.03|||||||Log Rank|Stratified log rank test||||||0.03
74101729|NCT04976621|147753391|OTHER|Because this was a feasibility study, we did not compute inferential statistics and did not include a power calculation.||||||||||||Because this was a feasibility study, inferential statistics were not computed.||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
74101730|NCT04976621|147753392|OTHER|||||||||||||||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
74101731|NCT04976621|147753393|OTHER|||||||||||||||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
74101732|NCT04976621|147753394|OTHER||||||||||||||||||This analysis involved examination of the percentage that scored above a mean of 3.0 (our criteria for acceptability in this feasibility study).|||
74101733|NCT04976621|147753395|OTHER|||||||||||||||||Descriptive statistics are used to describe acceptability/satisfaction for those who received the BA intervention. This tool is completed after the last intervention session when the qualitative interview is also conducted.|Descriptive statistics are used in this feasibility study. We are not using inferential statistics to test for statistical significance.|||
73881877|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.7529|TWO_SIDED|95.0|-0.6|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.44|-0.60|0.7529
74101734|NCT04976621|147753396|OTHER||||||||||||||||||Descriptive statistics are used to describe recruitment.|||
74101735|NCT04976621|147753397|OTHER||||||||||||||||||One measure of retention was the percent in each group who completed the study, meaning completed the Time 2 follow-up interview (that occurred 3-4 months after the baseline interview). Another measure of retention was the percent in the treatment group that completed four or more treatment sessions.|||
74101736|NCT04976621|147753398|OTHER||||||||||||||||||For each of five participants who received the intervention, we reviewed a transcript of 1 intervention session for treatment fidelity. The criterion is that no more than 15% of sessions observed or audiotaped will have a mean less than 2.0.|||
74101737|NCT05992623|147753399|SUPERIORITY|||||||0.565|||||||Chi-squared|||||||0.565
74101738|NCT05992623|147753400|SUPERIORITY|||||||0.617|||||||Chi-squared|||||||0.617
74101739|NCT05992623|147753401|SUPERIORITY||Mean Difference (Final Values)|0.04|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73881878|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4173|TWO_SIDED|95.0|-0.73|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.31|-0.73|0.4173
73881879|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4944|TWO_SIDED|95.0|-0.34|0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.69|-0.34|0.4944
73881880|NCT03192176|147297636|SUPERIORITY||LSMean differencce|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9231|TWO_SIDED|95.0|-0.54|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.49|-0.54|0.9231
74059337|NCT00807040|147670898|OTHER|We tested this hypothesis in an intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level. This analysis accommodated nonignorable missing LVESVI outcomes owing to the death of patients by assigning deceased patients the worst ranks in order on the basis of the time of death. We used multiple imputation for data that were missing for reasons other than death to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.18|||||||Wilcoxon (Mann-Whitney)|||The trial was designed with a power of 90% to detect a between-group difference of 15 ml per square meter in the LVESVI from baseline to 12 months. We assumed a baseline LVESVI of 100 ml per square meter, improvements of 20 ml per square meter in the repair group and 35 ml per square meter in the replacement group, and equal 1-year mortality of 10 to 20% in the two groups. The primary null hypothesis was that there would be no between-group difference in the LVESVI at 12 months.||||0.18
74059338|NCT00807040|147670899|OTHER|We used the log-rank test to compare rates of death from baseline to 2 years.|Hazard Ratio (HR)|0.79||||0.39|TWO_SIDED|95.0|0.46|1.35|||Log Rank|||||1.35|0.46|0.39
74059339|NCT04776135|147670911|OTHER|AUC0-t was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|0.987|||||TWO_SIDED|90.0|0.936|1.041|||ANOVA|||For AUC0-t, MT-1186 orally Versus MT-1186 via NGT||1.041|0.936|
74059340|NCT04776135|147670911|OTHER|AUC0-inf was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|0.981|||||TWO_SIDED|90.0|0.931|1.033|||ANOVA|||For AUC0-inf, MT-1186 orally Versus MT-1186 via NGT||1.033|0.931|
74059341|NCT04776135|147670912|OTHER|Cmax was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|1.052|||||TWO_SIDED|90.0|0.903|1.227|||ANOVA|||MT-1186 orally Versus MT-1186 via NGT||1.227|0.903|
74059342|NCT03992261|147670943|OTHER|"Mean, median, SD, minimum/maximum determined for total amount of test article used by each subject in Safety, Evaluable, and PK populations HPA Axis Suppression: Proportion of subjects manifesting laboratory evidence of adrenal suppression at EOS were presented with 95% confidence intervals (CIs) for Evaluable and Safety populations. Descriptive statistics for daily dose of test article were tabulated separately for suppressed and non-suppressed subjects.~PK: Screening, Day 8, Day 15"||||||0.05|||||||ANOVA|||Outcome measure: extent of exposure, HPA axis suppression, and pharmacokinetic analysis.||||0.05
74059343|NCT00769132|147670944|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two treatments are comparable if the geometric mean ratio is contained within the interval \[0.50-2.00\].|Geometric least-squares mean ratio|1.12||||||90.0|0.9|1.38||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) \[Treatment A/B\] of the urine levels of 11-dTxB2 on Day 7.||1.38|0.9|
74059344|NCT00769132|147670944|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.07||||||||1.07|0.71|
74101740|NCT01495702|147753429|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the Stribild group was at least 12% worse than the NNRTI+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA \< 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the NNRTI+FTC/TDF group.|Difference in proportions|5.3||||0.066|TWO_SIDED|95.0|-0.5|12.0|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.|||12.0|-0.5|0.066
74101741|NCT04152863|147753433|SUPERIORITY||Mean Difference (Net)|11.9||||0.1812|TWO_SIDED|90.0|-9.5|32.5|||Stratified Miettinen & Nurminen method|To ensure adequate number of participants, strata were combined according to sSAP when one treatment had 0 participants in a particular stratum.||||32.5|-9.5|0.1812
74101742|NCT04152863|147753433|SUPERIORITY||Mean Difference (Net)|4.8||||0.3548|TWO_SIDED|90.0|-16.2|25.5|||Stratified Miettinen & Nurminen method|To ensure adequate number of participants, strata were combined according to sSAP when one treatment had 0 participants in a particular stratum.||||25.5|-16.2|0.3548
74101743|NCT04152863|147753433|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in %|7.1|||||TWO_SIDED|90.0|-14.6|28.2||||||||28.2|-14.6|
74059345|NCT00769132|147670944|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.8||||||90.0|0.65|0.98||||||||0.98|0.65|
74059346|NCT00769132|147670944|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.89||||||90.0|0.72|1.09||||||||1.09|0.72|
74059347|NCT00769132|147670944|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.91||||||90.0|0.74|1.12||||||||1.12|0.74|
74059348|NCT00769132|147670944|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|1.02||||||90.0|0.83|1.25||||||||1.25|0.83|
74059349|NCT00769132|147670945|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|1.04||||||90.0|0.92|1.17||||||||1.17|0.92|
74059350|NCT00769132|147670945|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.9||||||90.0|0.8|1.01||||||||1.01|0.8|
74059351|NCT00769132|147670945|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.56||||||90.0|0.49|0.63||||||||0.63|0.49|
74059352|NCT00769132|147670945|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.58||||||90.0|0.51|0.65||||||||0.65|0.51|
74059353|NCT00769132|147670945|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.62||||||90.0|0.55|0.7||||||||0.7|0.55|
74059354|NCT00769132|147670945|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.64||||||90.0|0.57|0.72||||||||0.72|0.57|
73881881|NCT03192176|147297636|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.5112|TWO_SIDED|95.0|-1.04|0.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.52|-1.04|0.5112
73881882|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.03|TWO_SIDED|95.0|-1.66|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||-0.09|-1.66|0.0300
73881883|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.0634|TWO_SIDED|95.0|-1.57|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.04|-1.57|0.0634
74059355|NCT01833897|147670966|SUPERIORITY_OR_OTHER||||||<|0.001||||||F1,6.4=161.8,|linear mixed model|||||||<0.001
74059356|NCT01833897|147670967|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74059357|NCT01833897|147670968|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||0.026
74059358|NCT01833897|147670969|SUPERIORITY_OR_OTHER|||||||0.011|||||||ANOVA|||||||0.011
74059359|NCT01833897|147670970|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74059360|NCT00127192|147670971|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.6|||<|0.001||95.0|-4.3|-3.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-3.0|-4.3|<0.001
74059361|NCT00127192|147670971|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.2|||<|0.001||95.0|-3.9|-2.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.6|-3.9|<0.001
74059362|NCT00127192|147670971|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.3|||<|0.001||95.0|-3.9|-2.7||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.7|-3.9|<0.001
74059363|NCT00127192|147670971|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-2.6|||<|0.001||95.0|-3.2|-2.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.0|-3.2|<0.001
74101744|NCT04152863|147753434|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.5|2.27||||||||2.27|0.50|
74059364|NCT00127192|147670972|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Tukeys linear trend test based on ANCOVA|Linear contrast including all groups was tested using ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline||||||<0.001
74059365|NCT00127192|147670972|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-1.04|||<|0.001||95.0|-1.21|-0.86||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, but the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.86|-1.21|<0.001
74059366|NCT00127192|147670972|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.96|||<|0.001||95.0|-1.14|-0.79||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.79|-1.14|<0.001
74059367|NCT00127192|147670972|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.99|||<|0.001||95.0|-1.16|-0.82||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.82|-1.16|<0.001
74101745|NCT04152863|147753434|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.51|2.29||||||||2.29|0.51|
73881884|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.9406|TWO_SIDED|95.0|-0.78|0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.84|-0.78|0.9406
74059368|NCT00127192|147670972|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.69|||<|0.001||95.0|-0.85|-0.52||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.52|-0.85|<0.001
74059369|NCT00127192|147670973|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-23.2|||<|0.001||95.0|-29.8|-16.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-16.6|-29.8|<0.001
74059370|NCT00127192|147670973|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-20.8|||<|0.001||95.0|-27.4|-14.3||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-14.3|-27.4|<0.001
74059371|NCT00127192|147670973|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-17.7|||<|0.001||95.0|-24.2|-11.2||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-11.2|-24.2|<0.001
74059372|NCT00127192|147670973|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-15.9|||<|0.001||95.0|-22.3|-9.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-9.6|-22.3|<0.001
74059373|NCT00077766|147670974|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with 90% power assuming that the true difference between the RO0503821 group and darbepoetin was not larger than 0.3 g/dL.|Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.1162|<|0.0001|TWO_SIDED|95.0|-0.049|0.408||The p-value for the non-inferiority test was derived using ANCOVA.|ANCOVA, CI for difference between groups|Degrees of Freedom : 246|Difference between groups based on the adjusted means derived from the ANCOVA model.|RO0503821 group was compared to darbepoetin alfa group, using analysis of covariance (ANCOVA) with the independent variable as treatment group and Hb at baseline and geographical region as covariates. The test for non-inferiority was based on the lower limit of 2-sided 95% confidence interval (CI) for difference in adjusted mean between 2 groups. If this lower limit was \> or = to -0.75 g/dL, the RO0503821 group was regarded as clinically non-inferior to darbepoetin alfa group, with 90% power.||0.408|-0.049|< 0.0001
74059374|NCT02181075|147670985|SUPERIORITY|||||||0.024||||||Not adjusted for multiple comparisons. A priori threshold \< 0.05|t-test, 2 sided|95% confidence interval (CI)||A paired t-test was used for Part I (Arm 1) only. Analysis only applies to Part I (Arm 1) because only this study arm has matched Post-LTLD (i.e. post-drug alone) and Post-LTLD+FUS biopsy samples obtained from the same liver tumours before and after targeted drug delivery. In Part II of the study design in which drug delivery occurred completely non-invasively, no Post-LTLD tissue sample is obtained and only a single tumour biopsy is obtained following drug delivery (Post-LTLD+FUS).||||0.024
74059375|NCT04150107|147670991|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|Least mean squares||||<|0.9223|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9223
74059376|NCT04150107|147670992|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.8871|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.8871
74059377|NCT04150107|147670993|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.9641|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9641
74101746|NCT04152863|147753434|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.5|2.04||||||||2.04|0.50|
74101747|NCT04152863|147753436|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|-2.1|||||TWO_SIDED|90.0|-23.1|19.2||||||||19.2|-23.1|
74101748|NCT04152863|147753436|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|-2.1|||||TWO_SIDED|90.0|-23.1|19.2||||||||19.2|-23.1|
74101749|NCT04152863|147753436|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in %|0.0|||||TWO_SIDED|90.0|-21.2|21.2||||||||21.2|-21.2|
74059378|NCT04150107|147670994|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.7922|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.7922
74059379|NCT04150107|147670995|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.9898|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9898
74059380|NCT04150107|147670996|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.5165|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.5165
74059381|NCT00741026|147671050|SUPERIORITY_OR_OTHER|||||||0.0203|||||||Wilcoxon Signed-rank|||||||0.0203
74059382|NCT00741026|147671051|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Wilcoxon Sign-rank|||||||0.0105
74059383|NCT00741026|147671052|SUPERIORITY_OR_OTHER|||||||0.0166|||||||Wilcoxon Sign-rank|||||||0.0166
74059384|NCT00741026|147671053|SUPERIORITY_OR_OTHER|||||||0.0184|||||||Wilcoxon Sign-rank|||||||0.0184
74059385|NCT00741026|147671054|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon Sign-rank|||||||0.0170
74059386|NCT03256526|147671094|SUPERIORITY||LS mean difference|11.45||||0.1654|TWO_SIDED|90.0|-2.19|25.09|||ANCOVA|||||25.09|-2.19|0.1654
74059387|NCT03256526|147671094|SUPERIORITY||LS mean difference|-18.73||||0.0395|TWO_SIDED|90.0|-33.55|-3.9|||ANCOVA|||||-3.90|-33.55|0.0395
74059388|NCT00566969|147671137|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hierarchical linear model was used to account for unequal variance and covariance structures across time.||||||0.1|||||||ANOVA|||||||.10
74101750|NCT04152863|147753437|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.7|3.02||||||||3.02|0.70|
74059389|NCT01299272|147671145|SUPERIORITY_OR_OTHER|||||||0.485|||||||Log Rank|||||||0.485
74059390|NCT00464308|147671174|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.11|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|Non-inferiority||Assumed that the true resolution rates in the rab20 and eso40 groups would be 30% (0.3). Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
74059391|NCT00464308|147671177|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.051|||<|0.05||95.0||||All statistical tests were interpreted at the 5% significance level (2-tailed).|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
74059392|NCT00464308|147671178|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.053|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
74101751|NCT04152863|147753437|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.62|2.68||||||||2.68|0.62|
74101752|NCT04152863|147753437|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.6|2.22||||||||2.22|0.60|
74059393|NCT00464308|147671179|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.061|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
74059394|NCT03533608|147671209|OTHER|Descriptive|Mean Difference (Final Values)|19.51|||||TWO_SIDED|||||||||||||
74059395|NCT03533608|147671210|OTHER|Descriptive|Mean Difference (Final Values)|4.04|||||TWO_SIDED|||||||||||||
74059396|NCT01900392|147671256|OTHER||||||>|0.1|||||||Regression, Linear|||||||>0.1
74059397|NCT00826176|147671271|SUPERIORITY_OR_OTHER||upper limit of tolerance interval (min.)|6.4||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.|||||
74059398|NCT00826176|147671271|SUPERIORITY_OR_OTHER||upper limit of tolerance interval (min.)|3.2||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.|||||
74059399|NCT00826176|147671271|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence between the two subject populations was to be claimed in the event that the two-sided 95% confidence interval was entirely within the interval ranging from -60 to +60 seconds.|median difference (seconds)|49.0||||||95.0|30.0|72.0|||||The estimated median difference (Chinese minus Caucasian) in time to recovery of the T4/T1 ratio to 0.9.|||72|30|
74059400|NCT01687400|147671274|OTHER|||||||0.035|||||||Fisher Exact|||Statistical analysis #1 is for the genetic mutation TP53.||||0.035
74059401|NCT01687400|147671274|OTHER|||||||0.72|||||||Fisher Exact|||Statistical analysis #2 is for ASXL1 genetic mutation||||0.72
74059402|NCT01687400|147671274|OTHER|||||||0.28|||||||Fisher Exact|||Statistical analysis #3 is for SRSF2 genetic mutation||||0.28
74059403|NCT01687400|147671274|OTHER|||||||0.14|||||||Fisher Exact|||Statistical analysis #4 is for IDH2 genetic mutation||||0.14
74059404|NCT01687400|147671274|OTHER|||||||0.3|||||||Fisher Exact|||Statistical analysis #5 is for DNMT3A genetic mutation||||0.3
74059405|NCT01687400|147671274|OTHER|||||||0.183|||||||Fisher Exact|||Statistical analysis #6 is for SF3B1 genetic mutation||||0.183
74059406|NCT01687400|147671274|OTHER|||||||0.42|||||||Fisher Exact|||Statistical analysis #7 is for RUNX1 genetic mutation||||0.42
74059407|NCT01687400|147671274|OTHER|||||||0.36|||||||Fisher Exact|||Statistical analysis #8 is for TET2 genetic mutation||||0.36
74059408|NCT01687400|147671274|OTHER|||||||0.1|||||||Fisher Exact|||Statistical analysis #9 is for IDH1 genetic mutation||||0.1
74059409|NCT01687400|147671274|OTHER|||||||1|||||||Fisher Exact|||Statistical analysis #10 is for NPM1 genetic mutation||||1
74059410|NCT01687400|147671274|OTHER|||||||0.17|||||||Fisher Exact|||Statistical analysis #11 is for NRAS genetic mutation||||0.17
74059411|NCT01687400|147671274|OTHER|||||||1|||||||Fisher Exact|||-Statistical analysis #12 is for U2AF1 genetic mutation||||1
74059412|NCT01687400|147671274|OTHER|||||||0.6|||||||Fisher Exact|||Statistical analysis #13 is for MY05B genetic mutation||||0.6
74059413|NCT01687400|147671274|OTHER|||||||1|||||||Fisher Exact|||Statistical analysis #14 is for WT1 genetic mutation||||1
74059414|NCT01687400|147671275|SUPERIORITY||Overall Response Rate-for current study|0.744|||<|0.0001|TWO_SIDED|95.0|0.652|0.836|||Chi-squared|1-sample Chi-square test to compare the overall response rate (ORR) to historical control (with ORR=0.25)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 25% (14 out of 55 participants) in overall response rate||0.836|0.652|<0.0001
74059415|NCT01687400|147671275|SUPERIORITY||Complete response rate-for current study|0.64|||<|0.0001|TWO_SIDED|95.0|0.538|0.741|||Chi-squared|1-sample Chi-square test to compare the complete response rate to historical control (with CR=0.24)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 24% (13 out of 55 participants) in complete response rate.||0.741|0.538|<0.0001
74059416|NCT03731325|147671281|SUPERIORITY||Mean Difference (Net)|2.2|||<|0.01|TWO_SIDED||||||ANOVA||This mean difference represents the main effect of time from baseline to 15 weeks, regardless of group|Change in parent BMI from baseline at 8,11 to 15 weeks||||<0.01
74059417|NCT03731325|147671282|SUPERIORITY||Mean Difference (Net)|-10.5||||0.003|TWO_SIDED|||||main effect of time|ANOVA||This is the main effect of weight change at week 15, e.g. average weight change from baseline to week 15 in the entire sample of parents|repeated measures analysis of variance for time (0,8,11,15 weeks) for weight change (lbs)||||0.003
74059418|NCT03731325|147671283|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.06|TWO_SIDED||||||ANOVA||average difference in BMI percentile for entire sample|Repeated measures ANOVA for child BMI percentile at 0, 8, 11 and 15 weeks||||0.06
74059419|NCT03731325|147671284|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.07|TWO_SIDED||||||ANOVA||average change in delay discounting measure area under the curve for all participants (parents and children) in both groups from baseline to week 15|repeated measures ANOVA, reporting repeated measures effect only||||0.07
74059420|NCT03731325|147671285|SUPERIORITY||Mean Difference (Net)|-0.8||||0.64|TWO_SIDED||||||ANOVA||Difference between weight at baseline and week 15 in lbs for all children, regardless of group|||||0.64
74059421|NCT00297882|147671291|NON_INFERIORITY|Non-inferiority of AQ-AS compared to AL was assessed by constructing a one-sided, lower limit asymptotic 97.5% CI on the difference of polymerase chain reaction (PCR)-corrected cure rates of AQ-AS when compared to AL. Non-inferiority was declared if the lower limit of the CI was greater than -10% for AQ-AS.|||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample Size will be determined by N = {\[(Zα/2)/E\]\*2}pq where Where: n=sample size; Zα/2= Z value of a two-tailed test with 95% confidence level=1.96; p represents cure rate, q=1-p, which represents treatment failure rate of; E=precision of 5%||||>0.05
74059422|NCT00297882|147671292|NON_INFERIORITY|Non-inferiority of AQ-AS compared to AL was assessed by constructing a one-sided, lower limit asymptotic 97.5% CI on the difference of polymerase chain reaction (PCR)-corrected cure rates of AQ-AS when compared to AL. Non-inferiority was declared if the lower limit of the CI was greater than -10% for AQ-AS.|||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample Size will be determined by N = {\[(Zα/2)/E\]\*2}pq where Where: n=sample size; Zα/2= Z value of a two-tailed test with 95% confidence level=1.96; p represents cure rate, q=1-p, which represents treatment failure rate of; E=precision of 5%||||>0.05
74059423|NCT00848965|147671300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.08|-0.68|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-0.68|-2.08|
74059424|NCT00848965|147671300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.309|||TWO_SIDED|95.0|-2.16|-0.93|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-0.93|-2.16|
74059425|NCT00848965|147671300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-2.33|-1.11|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-1.11|-2.33|
74059426|NCT00848965|147671300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|-2.6|-1.19|||||Treatment difference is presented as the difference in the adjusted means for treatment versus placebo.|||-1.19|-2.60|
74059427|NCT02329834|147671318|EQUIVALENCE|90% Confidence Interval 80\<ratio of AUC\<125. The FDA guided Bioequivalence limit of 80 to 125% for the ratio of the product averages has been adopted for use of an average BE criterion.|% diff Geometric Least Squared Mean|99.5|||||TWO_SIDED|90.0|94.77|104.75||||||||104.75|94.77|
74059428|NCT02329834|147671319|OTHER||% Diff Geometric Least Squared Mean|99.65|||||TWO_SIDED|90.0|94.79|104.75||||||||104.75|94.79|
74059429|NCT00561600|147671330|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority of proportion successful with 8% non inferiority margin at 24 months|percentage difference|0.139||||0.872|ONE_SIDED|95.0||0.225|||Chi-squared||The upper confidence limit was a priori determined to be a secondary endpoint|A non-inferiority test of the proportion successful for each treatment group will be the primary test of efficacy in this investigation. The null hypothesis is Ho: Xc-Xt ≥ 0.08 and the alternative hypothesis is HA:Xc-Xt \< 0.08 Sample size of 126 per group was needed assuming 93% success rates, this was increased to 150 per group to account for attrition.||.225||0.872
74059430|NCT00561600|147671331|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||t-test, 2 sided|Satterthwaite||||||0.167
74059431|NCT00561600|147671334|SUPERIORITY_OR_OTHER|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
74059432|NCT00561600|147671335|SUPERIORITY_OR_OTHER|||||||0.762|||||||Wilcoxon (Mann-Whitney)|||||||0.762
74059433|NCT00561600|147671336|SUPERIORITY_OR_OTHER|||||||0.869|||||||Wilcoxon (Mann-Whitney)|||||||0.869
74059434|NCT00561600|147671337|SUPERIORITY_OR_OTHER|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||||||0.799
74059435|NCT00561600|147671338|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||<0.001
74059436|NCT00561600|147671339|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.032
74059437|NCT00561600|147671340|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||<0.001
74059438|NCT00561600|147671341|SUPERIORITY_OR_OTHER|||||||0.882|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.882
74059439|NCT00561600|147671342|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.005
74059440|NCT00561600|147671343|SUPERIORITY_OR_OTHER|||||||0.237|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.237
74059441|NCT00561600|147671344|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.001
74059442|NCT00561600|147671345|SUPERIORITY_OR_OTHER|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.121
74059443|NCT00561600|147671346|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum Cobalt ions were expected to be lower in the ASR-XL group||||0.012
74059444|NCT00561600|147671347|SUPERIORITY_OR_OTHER|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.103
74059445|NCT00561600|147671348|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.001
74059446|NCT00561600|147671349|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.300
74059447|NCT00561600|147671350|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.079
74059448|NCT00561600|147671351|SUPERIORITY_OR_OTHER|||||||0.766|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.766
74059449|NCT00561600|147671352|SUPERIORITY_OR_OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.018
74059450|NCT00561600|147671353|SUPERIORITY_OR_OTHER|||||||0.689|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.689
74059451|NCT00561600|147671354|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.048
74059452|NCT00561600|147671355|SUPERIORITY_OR_OTHER|||||||0.782|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.782
74101753|NCT04152863|147753439|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.71|3.79||||||||3.79|0.71|
73881885|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41||0.1168|TWO_SIDED|95.0|-1.46|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.16|-1.46|0.1168
73881886|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9937|TWO_SIDED|95.0|-0.79|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.80|-0.79|0.9937
73881887|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1858|TWO_SIDED|95.0|-1.32|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.26|-1.32|0.1858
74059453|NCT00561600|147671356|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.061
74059454|NCT00561600|147671357|SUPERIORITY_OR_OTHER|||||||0.957|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.957
74059455|NCT02181673|147671370|SUPERIORITY_OR_OTHER||Percent Difference|53.4|||<|0.001|TWO_SIDED|95.0|45.8|60.9|||Cochran-Mantel-Haenszel|||||60.90|45.80|<0.001
74059456|NCT03387267|147671424|OTHER||AUC under ROC curve|0.64|||||ONE_SIDED|95.0||0.72||||||||0.72||
74059457|NCT03387267|147671425|OTHER||AUC under ROC curve|0.65|||||TWO_SIDED|||||||||||||
74059458|NCT03387267|147671426|OTHER||AUC under ROC curve|0.576|||||TWO_SIDED|||||||||||||
74059459|NCT01418365|147671464|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|0.979|||||TWO_SIDED|90.0|0.961|0.998|||ANOVA|||||0.998|0.961|
74059460|NCT01418365|147671465|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.993|||||TWO_SIDED|90.0|0.951|1.04|||ANOVA|||||1.04|0.951|
74059461|NCT02222168|147671467|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|95.9|STANDARD_ERROR_OF_MEAN|50.7|||TWO_SIDED|90.0|72.593|126.682|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||126.682|72.593|
74059462|NCT02222168|147671467|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|82.13|STANDARD_ERROR_OF_MEAN|38.0|||TWO_SIDED|90.0|66.37|101.639|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||101.639|66.370|
74101754|NCT04152863|147753439|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.47|2.68||||||||2.68|0.47|
74101755|NCT04152863|147753439|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.64|3.02||||||||3.02|0.64|
74101756|NCT01807065|147753478|OTHER|||||||0.06|||||||Log Rank|||||||0.06
74101757|NCT05246670|147753484|SUPERIORITY||Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|-1.33|5.74||||||||5.74|-1.33|
74101758|NCT05246670|147753484|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|-5.23|5.41||||||||5.41|-5.23|
74101759|NCT05246670|147753484|SUPERIORITY||Mean Difference (Final Values)|2.11|||||TWO_SIDED|95.0|-2.87|7.09||||||||7.09|-2.87|
74101760|NCT05219448|147753510|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.17|TWO_SIDED|95.0|-3.2|18.0||Unadjusted p value presented. The a priori threshold for statistical significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same when compared to children in the no-treatment control arm (measured through hair biomarker).||18.0|-3.2|0.17
74101761|NCT05219448|147753511|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.6|TWO_SIDED|95.0|-24.3|14.0||Unadjusted P-value. The threshold for significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community A arm when compared to caregivers in the no-treatment control arm (measured through hair biomarker).||14.0|-24.3|0.60
74101762|NCT05219448|147753511|SUPERIORITY||Mean Difference (Final Values)|-24.7||||0.013|TWO_SIDED|95.0|-44.1|-5.4||The P-value is unadjusted. The threshold for significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community B when compared to caregivers in the no-treatment control arm (measured through hair biomarker).||-5.4|-44.1|0.013
74101763|NCT00911300|147753518|SUPERIORITY_OR_OTHER||Percentage of participants|0.5||||1|TWO_SIDED|95.0|-2.0|3.1|||Fisher Exact||The estimated value is the absolute percent difference between Fondaparinux and UFH/VKA.|||3.1|-2.0|1.000
74101764|NCT05124691|147753554|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
74059463|NCT02222168|147671468|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|107.41|STANDARD_ERROR_OF_MEAN|18.2|||TWO_SIDED|90.0|96.697|119.318|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||119.318|96.697|
74059464|NCT02222168|147671468|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|94.88|STANDARD_ERROR_OF_MEAN|19.1|||TWO_SIDED|90.0|85.028|105.875|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||105.875|85.028|
74101765|NCT05124691|147753554|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
74101766|NCT05124691|147753554|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
74101767|NCT05124691|147753557|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||Pairwise comparisons of cure rates were conducted between Albendazole and FDCx3, as well as FDCx1 and FDCx3, but not between Albendazole and FDCx1, since both contain the same dose regimen of the active drug. An overall significance level of 0.05 was considered, and to account for multiple testing, a Bonferroni correction was applied.||||<0.0001
74101768|NCT05124691|147753557|SUPERIORITY||||||=|0.0007|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates were conducted between Albendazole and FDCx3, as well as FDCx1 and FDCx3, but not between Albendazole and FDCx1, since both contain the same dose regimen of the active drug. An overall significance level of 0.05 was considered, and to account for multiple testing, a Bonferroni correction was applied.||||=0.0007
74101769|NCT05124691|147753560|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
74101770|NCT05124691|147753560|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74101771|NCT05124691|147753560|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74101772|NCT04739800|147753589|EQUIVALENCE|This is the Hazard Ratio of Group 2 compared to Group 1.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.44|2.31|||||This is the Hazard Ratio of Group 2 compared to Group 1.|||2.31|0.44|
74101773|NCT04739800|147753589|EQUIVALENCE|This is the Hazard Ratio of Group 3 compared to Group 1.|Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.52|2.84|||||This is the Hazard Ratio of Group 3 compared to Group 1.|||2.84|0.52|
74101774|NCT04739800|147753589|EQUIVALENCE|This is the Hazard Ratio of Group 4 compared to Group 1.|Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.58|3.08|||||||This is the Hazard Ratio of Group 4 compared to Group 1.|3.08|0.58|
74101775|NCT04739800|147753592|EQUIVALENCE|This is the Hazard Ratio of Group 2 compared to Group 1.|Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.44|4.47|||||This is the Hazard Ratio for Group 2 compared to Group 1.|||4.47|0.44|
74101776|NCT04739800|147753592|EQUIVALENCE|This is the Hazard Ratio of Group 3 compared to Group 1.|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.4|4.19|||||This is the Hazard Ratio of Group 3 compared to Group 1.|||4.19|0.40|
74101777|NCT04739800|147753592|EQUIVALENCE|This is the Hazard Ratio of Group 4 compared to Group 1.|Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.58|3.08|||||This is the Hazard Ratio of Group 4 compared to Group 1.|||3.08|0.58|
74101778|NCT02503787|147753609|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||A negative value for change in pain represents a reduction (improvement) of the subject's pain score. The null hypothesis was that the mean change from baseline to 3 months equals 0. The sample provided over 90% power, with two-sided significance level of 0.05, to detect a change of 2 points.||||<0.01
74101779|NCT00174954|147753629|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||The a priori threshold for statistical significance was 0.05.|paired t-test|||||||0.785
74101780|NCT00174954|147753630|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||The a priori threshold for statistical significance is 0.05.|paired t-test|||||||0.020
74101781|NCT00839254|147753631|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|82.8|100.0||P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||100|82.8|<0.0001
74101782|NCT00839254|147753632|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.|VE (1-RR)|91.8|||=|0.0009|TWO_SIDED|95.0|58.3|99.6||p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||99.6|58.3|= 0.0009
74101783|NCT01377012|147753737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0004|TWO_SIDED|95.0|1.4|3.4|||Regression, Logistic|||||3.4|1.4|0.0004
74101784|NCT01377012|147753737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0004|TWO_SIDED|95.0|1.4|3.4|||Regression, Logistic|||||3.4|1.4|0.0004
74101785|NCT03736031|147753783|SUPERIORITY|||||||0.09|||||||two-sample independent t-test|An alpha of 0.05 was used.||||||0.09
74101786|NCT03736031|147753784|SUPERIORITY|||||||0.81|||||||two-sample independent t-test|An alpha of 0.05 was used.||||||0.81
74101787|NCT03736031|147753785|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
74101788|NCT03736031|147753786|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74101789|NCT03939689|147753790|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test with adjustment for stratification factor (prostate cancer risk factor at Screening) was carried out by using complete cases for the FAS population (missing data were not imputed for this analysis). Intermediate risk at Screening: hemoglobin (Hgb) ≥11 g/dL and LDH \<262 IU/L and ALP \<414 IU/L. High-risk at Screening: Hgb \<11 g/dL or LDH ≥262 IU/L or ALP ≥414 IU/L.||||0.0025
74101790|NCT03939689|147753791|SUPERIORITY|||||||0.806||||||The p-value is based on the chi-squared test of the difference in proportions between treatment groups if expected cell frequencies are all greater than 5; otherwise, the p-value is from the Fisher's exact test.|Chi-squared|||||||0.8060
74101791|NCT03939689|147753792|SUPERIORITY|||||||0.5924||||||Log-rank test of no difference between treatment groups, stratified by prostate cancer risk groups.|Log Rank|||Kaplan-Meier analysis and Greenwood formula used for estimating event-free rates and 95% confidence intervals.||||.5924
74101792|NCT03939689|147753793|SUPERIORITY|||||||0.5924||||||Log-rank test of no difference between treatment groups, stratified by prostate cancer risk groups.|Log Rank|||Kaplan-Meier analysis and Greenwood formula used for estimating event-free rates and 95% confidence intervals.||||0.5924
74101793|NCT03939689|147753794|SUPERIORITY|||||||0.6199||||||P value from the log-rank test of no difference between treatment groups, stratified by prostate cancer risk group at Screening.|Log Rank|||Event-free rates and 95% CI were estimated by using Kaplan-Meier method and Greenwood formula.||||0.6199
74101794|NCT03939689|147753795|SUPERIORITY|||||||0.1823||||||P-value from the log-rank test of no difference between treatment groups, stratified by prostate cancer risk group at Screening.|Log Rank|||Event free rates and 95% CI were estimated by using Kaplan-Meier method and Greenwood formula.||||.1823
74101795|NCT03939689|147753796|SUPERIORITY|||||||0.0006||||||P-value from the log-rank test of no difference between treatment groups, stratified by prostate cancer risk group at Screening.|Log Rank|||Event-free rates and 95% CI were estimated by using Kaplan-Meier method and Greenwood formula.||||0.0006
74101796|NCT05665595|147753797|OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.87|1.8|||||Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma risk-based stage (IIB/IIC/clinical IIB and IIC/IIIA/IIIB vs IIIC/IIID/IV) and region of enrollment (Asia vs ROW).|||1.80|0.87|
74101797|NCT05771428|147753800|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.939||0.9819|TWO_SIDED|95.0|-1.87|1.83|||Mixed-effect Model Repeated Measurement|||||1.83|-1.87|0.9819
74101798|NCT05771428|147753800|SUPERIORITY||LS Mean of Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.931||0.6545|TWO_SIDED|95.0|-2.25|1.42|||Mixed-effect Model Repeated Measurement|||||1.42|-2.25|0.6545
74101799|NCT05771428|147753800|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|0.928||0.786|TWO_SIDED|95.0|-1.58|2.08|||Mixed-effect Model Repeated Measurement|||||2.08|-1.58|0.7860
74101800|NCT05920161|147753845|SUPERIORITY|||||||0.023|||||||t-test, 1 sided|||||||0.023
74101801|NCT05920161|147753845|SUPERIORITY|||||||0.068|||||||t-test, 1 sided|||||||0.068
74101802|NCT05920161|147753846|SUPERIORITY|||||||0.281|||||||t-test, 1 sided|||Within-group A - B (null \>0)||||0.281
74101803|NCT05920161|147753846|SUPERIORITY|||||||0.645|||||||t-test, 1 sided|||Within-group A - B (null \>0)||||0.645
74101804|NCT05920161|147753846|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||Between-group comparison||||0.245
74101805|NCT05920161|147753847|SUPERIORITY|||||||0.143|||||||t-test, 1 sided|||||||0.143
74101806|NCT05920161|147753847|SUPERIORITY|||||||0.797||||||above chance 0.5|t-test, 1 sided|||||||0.797
74101807|NCT05920161|147753847|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
74101808|NCT05920161|147753848|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||A condition||||<0.0001
74101809|NCT05920161|147753848|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||B condition||||<0.0001
74101810|NCT05920161|147753848|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||X condition||||<0.0001
74059465|NCT02222168|147671469|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|107.41|STANDARD_ERROR_OF_MEAN|18.2|||TWO_SIDED|90.0|96.709|119.301|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||119.301|96.709|
74059466|NCT02222168|147671469|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|94.92|STANDARD_ERROR_OF_MEAN|19.1|||TWO_SIDED|90.0|85.061|105.921|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||105.921|85.061|
74059467|NCT02087865|147671474|SUPERIORITY||Mean Difference (Final Values)|-8.25|STANDARD_ERROR_OF_MEAN|7.59||0.273|TWO_SIDED|95.0|-23.12|6.63|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||6.63|-23.12|0.273
74059468|NCT02087865|147671475|SUPERIORITY||Mean Difference (Final Values)|-13.41|STANDARD_ERROR_OF_MEAN|3.92||0.001|TWO_SIDED|95.0|-21.09|-5.73|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-5.73|-21.09|0.001
74059469|NCT02087865|147671476|SUPERIORITY||Median Difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|5.48||0.115|TWO_SIDED|95.0|-19.33|2.14|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||2.14|-19.33|0.115
74059470|NCT02087865|147671477|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.09||0.941|TWO_SIDED|95.0|-3.94|4.25|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||4.25|-3.94|0.941
74059471|NCT02087865|147671478|SUPERIORITY||Mean Difference (Final Values)|46.33|STANDARD_ERROR_OF_MEAN|15.4||0.003|TWO_SIDED|95.0|16.14|76.53|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||76.53|16.14|0.003
74059472|NCT02087865|147671479|SUPERIORITY||Mean Difference (Final Values)|61.36|STANDARD_ERROR_OF_MEAN|13.32|<|0.001|TWO_SIDED|95.0|35.25|87.46|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||87.46|35.25|<0.001
74059473|NCT02087865|147671480|SUPERIORITY||Mean Difference (Final Values)|-3.35|STANDARD_ERROR_OF_MEAN|1.18||0.005|TWO_SIDED|95.0|-5.65|-1.04|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-1.04|-5.65|0.005
74059474|NCT02087865|147671481|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.67||0.011|TWO_SIDED|95.0|-7.58|-1.02|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-1.02|-7.58|0.011
74059475|NCT01392469|147671487|SUPERIORITY||Ratio (Test/Reference)|1.17|||||TWO_SIDED|90.0|1.03|1.33||||||||1.33|1.03|
74059476|NCT01392469|147671487|SUPERIORITY||Ratio (Test/Reference)|1.4|||||TWO_SIDED|90.0|1.23|1.59||||||||1.59|1.23|
74059477|NCT01392469|147671488|SUPERIORITY||Ratio (Test/Reference)|1.36|||||TWO_SIDED|90.0|1.14|1.62||||||||1.62|1.14|
74059478|NCT01392469|147671488|SUPERIORITY||Ratio (Test/Reference)|1.7|||||TWO_SIDED|90.0|1.43|2.03||||||||2.03|1.43|
74059479|NCT01392469|147671489|SUPERIORITY||Ratio (Test/Reference)|1.0|||||TWO_SIDED|90.0|0.82|1.21||||||||1.21|0.82|
74059480|NCT01392469|147671489|SUPERIORITY||Ratio (Test/Reference)|1.07|||||TWO_SIDED|90.0|0.88|1.31||||||||1.31|0.88|
74059481|NCT01392469|147671490|SUPERIORITY||Ratio (Test/Reference)|1.28|||||TWO_SIDED|90.0|1.03|1.61||||||||1.61|1.03|
74059482|NCT01392469|147671490|SUPERIORITY||Ratio (Test/Reference)|1.56|||||TWO_SIDED|90.0|1.24|1.95||||||||1.95|1.24|
74059483|NCT02712359|147671510|NON_INFERIORITY|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\_Year 8 Group minus Havrix 2 doses\_Year 8 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-23.33|||<|0.0001|TWO_SIDED|95.0|-28.78|-18.29|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\_Year 8 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\_Year 8 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 8 years after the administration of the last vaccine dose.||-18.29|-28.78|<0.0001
74059484|NCT02712359|147671511|NON_INFERIORITY|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\_Year 10 Group minus Havrix 2 doses\_Year 10 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-24.43|||<|0.0001|TWO_SIDED|95.0|-30.11|-19.03|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\_Year 10 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\_Year 10 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 10 years after the administration of the last vaccine dose.||-19.03|-30.11|<0.0001
74101811|NCT05920161|147753849|SUPERIORITY||||||<|0|||||||t-test, 1 sided|||||||< 0.000
74101812|NCT05920161|147753849|SUPERIORITY|||||||0.0008|||||||t-test, 1 sided|||||||0.0008
74059485|NCT00684645|147671545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.395|||<|0.0001|TWO_SIDED|95.0|0.257|0.609|||Cox proportional hazard|||Time to PFS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).||0.609|0.257|<0.0001
74059486|NCT00684645|147671546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.361||||0.0221|TWO_SIDED|95.0|0.151|0.864|||Cox proportional hazard|||Time to OS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).||0.864|0.151|0.0221
74059487|NCT03126682|147671557|SUPERIORITY|||||||0.212||||||Threshold of \<0.05|t-test, 2 sided|||||||0.212
74059488|NCT02513095|147671568|SUPERIORITY||Odds Ratio (OR)|6.0||||0.396|TWO_SIDED|95.0|0.6|76.8|||Chi-squared, Corrected|||||76.8|0.6|0.396
74059489|NCT01441401|147671597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045|||||||Fisher Exact|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no association between the baseline severity of epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."||||0.045
74059490|NCT01441401|147671597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Armitage (EXACT)|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the baseline severity of epileptic seizure (mild, moderate, and severe)."||||0.017
74059491|NCT01441401|147671598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Fisher Exact|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."||||0.018
74059492|NCT01441401|147671599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Fisher Exact|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."||||0.034
74059493|NCT01441401|147671599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Cochran-Armitage (EXACT)|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the increasing number of concomitant antiepileptic drugs at baseline."||||0.005
74059494|NCT01441401|147671600|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||"The factor tested was treatment period with gabapentin. The null hypothesis was that there was no association between the treatment period with gabapentin and the number of participants who responded to the treatment with gabapentin."||||<0.001
74059495|NCT01607398|147671623|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.05||||0.5146|TWO_SIDED|95.0|-20.5|7.6|||Wilcoxon (Mann-Whitney)|The analysis was done using the Van Elteren extension to the Wilcoxon rank sum test.|From Van-Elteren extension to the Wilcoxon Rank Sum test, adjusted for smoking status strata and Hodges-Lehmann estimator of the 95% CI, not stratified and unadjusted for multiplicity.|||7.600|-20.500|0.5146
74059496|NCT01107834|147671643|SUPERIORITY_OR_OTHER|||||||0.27|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.27
74101813|NCT05920161|147753850|SUPERIORITY|||||||0.083|||||||t-test, 1 sided|||||||0.083
74101814|NCT05920161|147753850|SUPERIORITY|||||||0.088|||||||t-test, 1 sided|||||||0.088
74101815|NCT01841736|147753858|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0005|TWO_SIDED|80.0|0.42|0.69|||Log Rank|Stratified log rank||||0.69|0.42|0.0005
74101816|NCT01841736|147753860|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.7|TWO_SIDED|80.0|0.84|1.51|||Log Rank|Stratified Log-Rank||||1.51|0.84|0.7
74101817|NCT05620108|147753891|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
74101818|NCT03068273|147753895|SUPERIORITY|||||||0.146|||||||Regression, Linear|||||||0.1460
74101819|NCT03068273|147753895|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
74101820|NCT03068273|147753895|SUPERIORITY||Mean Difference (Net)|6.338|STANDARD_ERROR_OF_MEAN|4.331|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
74101821|NCT03068273|147753896|SUPERIORITY||Mean Difference (Net)|9.141|STANDARD_ERROR_OF_MEAN|4.838||0.0615|TWO_SIDED||||||Regression, Linear|||||||0.0615
74101822|NCT03068273|147753897|SUPERIORITY||Mean Difference (Net)|11.257|STANDARD_ERROR_OF_MEAN|4.775||0.0404|TWO_SIDED||||||Regression, Linear|||||||0.0404
74101823|NCT03068273|147753898|SUPERIORITY||Mean Difference (Net)|0.155|STANDARD_ERROR_OF_MEAN|0.354||0.268|TWO_SIDED||||||Regression, Linear|||||||0.2680
74101824|NCT03068273|147753899|SUPERIORITY||Mean Difference (Net)|-11.412|STANDARD_ERROR_OF_MEAN|4.839||0.0403|TWO_SIDED||||||Regression, Linear|||||||0.0403
74101825|NCT03569293|147753900|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|63.4|||<|0.001|TWO_SIDED|95.0|57.1|69.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||69.8|57.1|<0.001
74101826|NCT03569293|147753900|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.3|||<|0.001|TWO_SIDED|95.0|46.4|60.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.2|46.4|<0.001
74101827|NCT03569293|147753901|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|47.2|60.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||60.0|47.2|<0.001
74101828|NCT03569293|147753901|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|39.8|||<|0.001|TWO_SIDED|95.0|33.2|46.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||46.4|33.2|<0.001
74101829|NCT03569293|147753902|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.2|||<|0.001|TWO_SIDED|95.0|41.3|55.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||55.0|41.3|<0.001
74101830|NCT03569293|147753902|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.5|||<|0.001|TWO_SIDED|95.0|33.5|47.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||47.5|33.5|<0.001
74101831|NCT03569293|147753903|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.8|||<|0.001|TWO_SIDED|95.0|51.5|64.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||64.1|51.5|<0.001
74101832|NCT03569293|147753903|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|45.1|||<|0.001|TWO_SIDED|95.0|38.6|51.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||51.7|38.6|<0.001
74101833|NCT03569293|147753904|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|62.3|||<|0.001|TWO_SIDED|95.0|56.3|68.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||68.3|56.3|<0.001
74101834|NCT03569293|147753904|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.1|||<|0.001|TWO_SIDED|95.0|40.7|53.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.4|40.7|<0.001
73881888|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.5765|TWO_SIDED|95.0|-0.65|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.36|-0.65|0.5765
73881889|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.1848|TWO_SIDED|95.0|-0.86|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.17|-0.86|0.1848
74059497|NCT01107834|147671644|SUPERIORITY_OR_OTHER|||||||0.46|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.46
74059498|NCT01107834|147671645|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.13
74059499|NCT01107834|147671646|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.59
74059500|NCT01107834|147671647|SUPERIORITY_OR_OTHER|||||||0.09|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.09
74059501|NCT01107834|147671648|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.03
74059502|NCT04139642|147671658|SUPERIORITY||||||<|0.0001||||||A mixed-effects model with provider as a random effect and month as a fixed effect was used to test the main effect of arm.|Mixed Models Analysis|||The null hypothesis was that the rate of balance-related diagnosis as a percentage of total visits would be the same between the historical control period, the active control (weight-only), and the intervention (balance+weight), considering provider and month as co-variates.||||<0.0001
74059503|NCT04139642|147671659|SUPERIORITY||||||=|0.15||||||Mixed-effects model with provider as a random effect and month as a fixed effect. Statistical significance a priori threshold set at 0.05.|Mixed Models Analysis|||The null hypothesis was that the rate of balance-related referral as a percentage of total visits would be the same between the historical control period, the active control (weight-only), and the intervention (balance+weight), considering provider and month as co-variates.||||=0.15
74059504|NCT02871921|147671662|EQUIVALENCE|A linear regression model was run with the outcome being the MoCA score at Month 6, controlling for the baseline MoCA score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.86||0.87|TWO_SIDED||||||Regression, Linear|||Outcome: MoCA at Month 6 Among participants with normal cognition||||0.87
74059505|NCT02871921|147671662|EQUIVALENCE|A linear regression model was run with the outcome being the MoCA score at Month 6, controlling for the baseline MoCA score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score.|Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|0.76||0.03|TWO_SIDED||||||Regression, Linear|||Outcome: MoCA at Month 6 Among MCI||||.03
74059506|NCT02871921|147671663|EQUIVALENCE|A linear regression model was run with the outcome being the Category Fluency test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|2.56|STANDARD_ERROR_OF_MEAN|1.19||0.03|TWO_SIDED||||||Regression, Linear|||Outcome: Category fluency animals Among participants with normal cognition||||0.03
74059507|NCT02871921|147671663|OTHER|A linear regression model was run with the outcome being the Category Fluency test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.93||0.46|TWO_SIDED||||||Regression, Linear|||Outcome: Category Fluency (Animals) at Month 6 Among MCI participants||||0.46
74059508|NCT02871921|147671664|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Stroy Immediate Recall score at Month 6, controlling for its baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.82||0.45|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Stroy Immediate Recall (paraphrase scoring) Among participants with normal cognition||||0.45
74059509|NCT02871921|147671664|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.8||0.41|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Immediate Recall (paraphrase) Among MCI||||0.41
73881890|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.7299|TWO_SIDED|95.0|-0.43|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.61|-0.43|0.7299
74059510|NCT02871921|147671665|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Median Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.77||0.74|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Delayed Recall) (Paraphrase scoring) Among participants with normal cognition||||0.74
74059511|NCT02871921|147671665|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.79||0.9|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Delayed Recall (Paraphrase scoring) Among MCI||||0.90
74059512|NCT00258310|147671667|SUPERIORITY_OR_OTHER_LEGACY||proportion|0.74|||||TWO_SIDED|95.0|0.59|0.9||||||||.90|.59|
74059513|NCT01139801|147671679|SUPERIORITY||Mean Difference (Final Values)|212.2||||0.037|TWO_SIDED|95.0|13.3|411.0|||t-test, 2 sided|||||411.0|13.3|0.037
74059514|NCT03159611|147671681|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
74059515|NCT03159611|147671682|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
73888216|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|81.7||||0.054|TWO_SIDED|95.0|-1.4|164.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||164.9|-1.4|0.0540
74059516|NCT03159611|147671683|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.50
74059517|NCT03159611|147671684|SUPERIORITY|||||||0.2|||||||Cochran-Mantel-Haenszel|||||||0.20
74059518|NCT03159611|147671685|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
74059519|NCT00518011|147671686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.842||||0.3644|TWO_SIDED|95.0|0.483|7.027|||Log Rank|||||7.027|0.483|0.3644
74059520|NCT00518011|147671690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.278||||0.7165|TWO_SIDED|95.0|0.339|4.824|||Log Rank|||||4.824|0.339|0.7165
74059521|NCT02596009|147671694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.97|||<|0.0001|TWO_SIDED|95.0|23.7|30.24|||paired t-test|||||30.24|23.70|<0.0001
74059522|NCT02596009|147671694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.93|||<|0.0001|TWO_SIDED|95.0|49.15|58.72|||paired t-test|||||58.72|49.15|<0.0001
74059523|NCT03930615|147671696|SUPERIORITY||Treatment Difference|-16.1||||0.0005|TWO_SIDED|95.0|-25.8|-6.5||A one-sided p-value ≤0.0249 was used for declaring statistical significance|Mantel Haenszel|Stratum adjusted|Letermovir minus placebo|It was hypothesized that LET is superior to placebo in the prevention of clinically significant CMV infection.|95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|-6.5|-25.8|0.0005
74059524|NCT03930615|147671697|OTHER||Difference in Percentage|-4.4|||||TWO_SIDED|95.0|-11.8|4.7|||||Letermovir minus Placebo||Miettinen \& Nurminen method|4.7|-11.8|
74059525|NCT03930615|147671698|OTHER||Difference in Percentage|3.5|||||TWO_SIDED|95.0|-2.7|8.6|||||Letermovir minus Placebo||Miettinen \& Nurminen method|8.6|-2.7|
74059526|NCT03930615|147671699|SUPERIORITY||Treatment Difference|-5.7||||0.1591|TWO_SIDED|95.0|-16.8|5.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.4|-16.8|0.1591
74059527|NCT03930615|147671700|SUPERIORITY||Treatment Difference|-5.7||||0.1591|TWO_SIDED|95.0|-16.8|5.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.4|-16.8|0.1591
74059528|NCT03930615|147671703|SUPERIORITY||Treatment difference|-14.1||||0.0012|TWO_SIDED|95.0|-23.3|-5.0|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|-5.0|-23.3|0.0012
74059529|NCT03930615|147671704|SUPERIORITY||Treatment Difference|-5.7||||0.1494|TWO_SIDED|95.0|-16.5|5.1|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.1|-16.5|0.1494
74059530|NCT03930615|147671705|SUPERIORITY||Treatment difference|0.7||||0.6244|TWO_SIDED|95.0|-3.8|5.3|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.3|-3.8|0.6244
74059531|NCT03930615|147671706|SUPERIORITY||Treatment Difference|0.3||||0.5264|TWO_SIDED|95.0|-7.9|8.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|8.4|-7.9|0.5264
74059532|NCT01281475|147671713|SUPERIORITY|We modeled each outcome variable as a function of treatment (ie, levodopa versus placebo), visit (ie, baseline vs. 12-month follow-up) and the treatment-by-visit interaction; the interaction term tests whether the effect of levodopa treatment over time is significantly greater than that of the placebo group.||||||0.75||||||This was the calculated p value without correction for multiple comparisons|Generalized estimating equations|||We performed generalized estimating equations with an unstructured covariance matrix to account for inter-correlations within measurements on the same participant over time.||||0.75
74059533|NCT02080273|147671727|OTHER|||||||0.919|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.919
74059534|NCT02080273|147671728|SUPERIORITY_OR_OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
74059535|NCT02080273|147671729|SUPERIORITY_OR_OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
74059536|NCT02080273|147671730|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
74059537|NCT02080273|147671731|OTHER|||||||0.922|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.922
74059538|NCT02080273|147671732|OTHER|||||||0.848||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline||||0.848
74059539|NCT02080273|147671733|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
73881891|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9415|TWO_SIDED|95.0|-0.54|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.50|-0.54|0.9415
73881892|NCT03192176|147297636|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.2742|TWO_SIDED|95.0|-0.82|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.23|-0.82|0.2742
74059540|NCT02080273|147671734|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
74059541|NCT00956813|147671735|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
74059542|NCT00956813|147671737|SUPERIORITY_OR_OTHER|||||||0.93|||||||Kruskal-Wallis|||||||0.93
74059543|NCT00956813|147671738|SUPERIORITY_OR_OTHER|||||||0.19|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for vasomotor-related questions in the MENQOL form.||||0.19
74059544|NCT00956813|147671738|SUPERIORITY_OR_OTHER|||||||0.78|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Psychosocial-related questions in the MENQOL form.||||0.78
74059545|NCT00956813|147671738|SUPERIORITY_OR_OTHER|||||||0.238|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Physical-related questions in the MENQOL form.||||0.238
74101835|NCT03569293|147753905|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|43.9|||<|0.001|TWO_SIDED|95.0|37.7|50.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.0|37.7|<0.001
74059546|NCT00956813|147671738|SUPERIORITY_OR_OTHER|||||||0.497|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Sexually-related questions in the MENQOL form.||||0.497
74059547|NCT00956813|147671739|SUPERIORITY_OR_OTHER|||||||0.089|||||||Kruskal-Wallis|||||||0.089
74059548|NCT03252015|147671844|SUPERIORITY||Mean Difference (Final Values)|-0.182|||||TWO_SIDED|95.0|-0.412|0.049||||||Day 7||0.049|-0.412|
74059549|NCT03252015|147671844|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.081|0.224||||||Day 7||0.224|-0.081|
74059550|NCT03252015|147671844|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
74059551|NCT03252015|147671844|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
74059552|NCT03252015|147671845|SUPERIORITY||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.34|0.05||||||Day 7||0.050|-0.340|
74059553|NCT03252015|147671845|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.081|0.224||||||||0.224|-0.081|
74059554|NCT03252015|147671845|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.151|0.294||||||Day 21||0.294|-0.151|
74059555|NCT03252015|147671845|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
74059556|NCT00379821|147671871|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0413|STANDARD_ERROR_OF_MEAN|0.1746||0.8097|TWO_SIDED|95.0|0.7497|1.4463||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.4463|0.7497|0.8097
74059557|NCT00379821|147671871|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1623|STANDARD_ERROR_OF_MEAN|0.1973||0.3767|TWO_SIDED|95.0|0.8333|1.6211||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.6211|0.8333|0.3767
74059558|NCT00379821|147671871|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0707|STANDARD_ERROR_OF_MEAN|0.1795||0.6277|TWO_SIDED|95.0|0.7708|1.4872||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.4872|0.7708|0.6277
74059559|NCT00379821|147671905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|STANDARD_ERROR_OF_MEAN|0.17||0.79|TWO_SIDED|95.0|0.68|1.34||Not adjusted, 0.05|Regression, Cox|There are no adjustments.|The reference category is those who did not travel.|||1.34|0.68|0.79
74059560|NCT04502862|147671914|OTHER||Least square mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.107||0.512|TWO_SIDED|95.0|-0.28|0.14||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|MMRM|||The MMRM model included study intervention, age, body mass index (BMI), region (Eastern Europe, rest of world \[ROW\]), inhaled corticosteroids \[ICS\] dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline asthma control questionnaire (ACQ-5), baseline sleep disturbance score and baseline-by-visit interaction as covariates.||0.14|-0.28|0.512
74059561|NCT04502862|147671915|OTHER||Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.11||0.967|TWO_SIDED|95.0|-0.21|0.22||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|MMRM|||The MMRM model included study intervention, age, BMI, region (Eastern Europe, ROW), ICS dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline ACQ-5, baseline number of nocturnal awakenings and baseline-by-visit interaction as covariates.||0.22|-0.21|0.967
74059562|NCT04502862|147671916|OTHER||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.865||0.422|TWO_SIDED|95.0|-2.4|1.01||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05|MMRM|||The MMRM model included study intervention, age, BMI, region (Eastern Europe, ROW), ICS dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline ACQ-5, baseline PROMIS total score and baseline-by-visit interaction as covariates.||1.01|-2.40|0.422
74059563|NCT01017731|147671930|SUPERIORITY_OR_OTHER|||||||0.0161||||||The p-value for QTc interval prolongation compared to baseline.|Mixed Models Analysis|||||||0.0161
74059564|NCT03926728|147671972|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].||||1
74059565|NCT03926728|147671972|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].||||1
74059566|NCT03926728|147671972|OTHER|||||||0.0007|||||||Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].||||0.0007
74059567|NCT03926728|147671975|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs A2.||||1
74059568|NCT03926728|147671975|OTHER|||||||0.3956|||||||Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs F1.||||0.3956
74059569|NCT03926728|147671976|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs A2.||||1
74059570|NCT03926728|147671976|OTHER|||||||0.3956|||||||Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs F1.||||0.3956
74059571|NCT03926728|147671978|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].||||1
74059572|NCT03926728|147671978|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].||||1
74059573|NCT03926728|147671978|OTHER|||||||0.3229|||||||Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].||||0.3229
74101836|NCT03569293|147753905|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|34.5|||<|0.001|TWO_SIDED|95.0|28.6|40.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||40.5|28.6|<0.001
74101837|NCT03569293|147753906|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|19.2|||<|0.001|TWO_SIDED|95.0|14.6|23.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||23.9|14.6|<0.001
74101838|NCT03569293|147753906|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|14.6|||<|0.001|TWO_SIDED|95.0|10.3|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||18.8|10.3|<0.001
74101839|NCT03569293|147753907|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|8.1|||<|0.001|TWO_SIDED|95.0|3.8|12.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||12.5|3.8|<0.001
74101840|NCT03569293|147753908|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|13.0|||<|0.001|TWO_SIDED|95.0|8.1|17.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||17.8|8.1|<0.001
74101841|NCT03569293|147753909|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-25.2|||<|0.001|TWO_SIDED|95.0|-30.3|-20.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-20.1|-30.3|<0.001
74101842|NCT03569293|147753909|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-29.3|-18.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-18.9|-29.3|<0.001
74059574|NCT02411110|147671988|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34||||0.505|||||||ANCOVA|Baseline value as a covariate; treatment group and stratification (age: \< 40 or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or \> 6) as factors.|LiRIS® - Placebo|||||0.505
74059575|NCT00539006|147672016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0|-1.5|-0.6|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo|FFNS combined across treatment arms 1 \& 2 compared with Placebo FFNS combined across treatment arms 1 \& 2.||-0.6|-1.5|<0.001
74059576|NCT00539006|147672016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.004||95.0|-1.1|-0.2|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo|FPNS combined across treatment arms 1 \& 2 compared with Placebo FPNS combined across treatment arms 1 \& 2.||-0.2|-1.1|0.004
74059577|NCT00539006|147672017|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximation to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.||Statistical analysis applies to FFNS and FPNS categories.||||<0.001
74059578|NCT01783860|147672021|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 1 sided|||||||0.03
74059579|NCT01783860|147672022|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||||||0.01
74059580|NCT01783860|147672023|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 1 sided|||||||0.007
74059581|NCT01783860|147672024|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 1 sided|||||||> 0.05
74059582|NCT01783860|147672025|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 1 sided|||||||0.02
74059583|NCT01783860|147672026|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 1 sided|||||||0.08
74101843|NCT03569293|147753910|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.9|||<|0.001|TWO_SIDED|95.0|45.2|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.6|45.2|<0.001
74059584|NCT00256217|147672027|OTHER||Mean Difference (Final Values)|4.9||||0.004|TWO_SIDED|95.0|1.8|8.0|||Wilcoxon (Mann-Whitney)|||||8.0|1.8|0.004
74059585|NCT00256217|147672028|OTHER||Mean Difference (Final Values)|0.3||||0.016|TWO_SIDED|95.0|0.1|0.49|||Wilcoxon (Mann-Whitney)|||||0.49|0.10|0.016
74059586|NCT01102972|147672034|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) for the difference in the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 24 was -12% or greater.|Treatment difference of proportions|0.33||||0.937||95.0|-7.97|8.64||The p-value was obtained from the Cochran-Mantel-Haenszel method stratified by initial antiretroviral regimen.|Cochran-Mantel-Haenszel||95% confidence intervals were calculated (using Mantel-Haenszel weight) stratified by initial antiretroviral regimen.|||8.64|-7.97|0.937
74059587|NCT01856257|147672064|SUPERIORITY||Mean Difference (Final Values)|3.512||||0.544|TWO_SIDED|95.0|-7.999|15.024|||Mixed Models Analysis||The p-value, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 2 to Group 1.|||15.024|-7.999|0.544
74059588|NCT01856257|147672064|SUPERIORITY||Mean Difference (Final Values)|4.82||||0.531|TWO_SIDED|95.0|-10.481|20.121|||Mixed Models Analysis||P-value estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 3 to Group 1.|||20.121|-10.481|0.531
74059589|NCT02325739|147672101|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fasted) is 120mg.|||||
74059590|NCT02325739|147672101|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fed) is 120mg.|||||
74059591|NCT02325739|147672101|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for FGF401 120mg.|||||
74059592|NCT02325739|147672101|OTHER||RP2D|300.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for PDR001 300mg.|||||
74059593|NCT03226366|147672120|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.29|TWO_SIDED|95.0|-20.4|6.1|||Regression, Linear||Change in emergency department door-to-antibiotic time (minutes) based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-antibiotic time after versus before intervention implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.||6.1|-20.4|0.29
74059594|NCT03226366|147672121|SUPERIORITY||Odds Ratio (OR)|0.81||||0.72|TWO_SIDED|95.0|0.25|2.61|||Regression, Logistic||Odds ratio for hospital mortality after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in odds of hospital mortality after versus before implementation at the intervention site with adjustment for observed change in outcome over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.||2.61|0.25|0.72
74059595|NCT03226366|147672122|SUPERIORITY||Mean Difference (Final Values)|-9.5||||0.26|TWO_SIDED|95.0|-25.9|7.0|||Regression, Linear||Change in emergency department length of stay (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department length of stay after versus before implementation at the intervention site with adjustment for the change observed over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.||7.0|-25.9|0.26
73881893|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.6946|TWO_SIDED|95.0|-0.41|0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.62|-0.41|0.6946
74101844|NCT03569293|147753910|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|41.8|||<|0.001|TWO_SIDED|95.0|33.9|49.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||49.7|33.9|<0.001
74101845|NCT03569293|147753911|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.6|||<|0.001|TWO_SIDED|95.0|41.0|56.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.1|41.0|<0.001
74101846|NCT03569293|147753911|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.7|||<|0.001|TWO_SIDED|95.0|30.9|46.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.5|30.9|<0.001
74101847|NCT03569293|147753912|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.9|||<|0.001|TWO_SIDED|95.0|45.4|60.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.3|45.4|<0.001
74101848|NCT03569293|147753912|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.3|||<|0.001|TWO_SIDED|95.0|30.4|46.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.2|30.4|<0.001
74101849|NCT03569293|147753913|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|44.7|60.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.4|44.7|<0.001
74101850|NCT03569293|147753913|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|42.7|||<|0.001|TWO_SIDED|95.0|34.4|50.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.9|34.4|<0.001
74101851|NCT03569293|147753914|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|44.9|61.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||61.3|44.9|<0.001
74101852|NCT03569293|147753914|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|44.7|||<|0.001|TWO_SIDED|95.0|36.2|53.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.2|36.2|<0.001
74101853|NCT03569293|147753915|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|25.3|||<|0.001|TWO_SIDED|95.0|20.0|30.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||30.6|20.0|<0.001
73881894|NCT03192176|147297636|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9442|TWO_SIDED|95.0|-0.53|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.50|-0.53|0.9442
74059596|NCT03226366|147672123|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.55|TWO_SIDED|95.0|-3.3|1.8|||Regression, Linear||Estimated change in emergency department door-to-physician evaluation time (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-physician evaluation time after versus before implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.||1.8|-3.3|0.55
74059597|NCT00530621|147672127|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13||||0.544||95.0|0.77|1.65||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status and time since last chemotherapy.|Log Rank|||||1.65|0.77|0.544
74059598|NCT00530621|147672128|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.171||95.0|0.42|1.17||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status and time since last chemotherapy.|Log Rank|||||1.17|0.42|0.171
74059599|NCT00530621|147672129|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.11||||0.01||95.0|1.19|3.75|||Regression, Cox|||||3.75|1.19|0.010
74059600|NCT00530621|147672130|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.5||||0.194||95.0|0.81|2.77||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status score and time since last chemotherapy.|Log Rank|||||2.77|0.81|0.194
74059601|NCT00530621|147672131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.681|||||||Fisher Exact|||||||0.681
74059602|NCT03409328|147672137|OTHER||F|38.44|||<|0.001|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||<.001
74059603|NCT03409328|147672138|OTHER||F|6.69||||0.013|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.013
74059604|NCT03409328|147672139|OTHER||F|5.07||||0.029|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.029
74059605|NCT03409328|147672140|OTHER||F|0.38||||0.542|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.542
74059606|NCT03409328|147672141|OTHER||F|3.12||||0.084|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||The outcome for this analysis is internalized stigma.||||.084
74059607|NCT03409328|147672141|OTHER||F|0.67||||0.417|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||The outcome for this analysis is identity affirmation.||||.417
74059608|NCT04611152|147672188|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin|Adjusted mean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.84||0.4162|TWO_SIDED|95.04|-5.47|-2.17|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA and OCT CST.||||-2.17|-5.47|0.4162
74059609|NCT04611152|147672189|NON_INFERIORITY|"The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%"|Difference of weighted percentages|0.6|||<|0.0001|TWO_SIDED|95.04|-0.7|2.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by study identifier and randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||2|-0.7|<0.0001
74059610|NCT04611152|147672190|NON_INFERIORITY|"The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%"|Difference of weighted percentages|0.0|||||TWO_SIDED|95.04|0.0|0.0|||||Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||0|0|
74059611|NCT03728257|147672218|SUPERIORITY|Change in average steps per day between baseline and 3 months was compared between the two groups.||||||0.8793||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.8793
74059612|NCT03728257|147672219|SUPERIORITY|Change in average steps per day between baseline and 6 months was compared between the two groups.||||||0.9597||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.9597
74059613|NCT03728257|147672220|SUPERIORITY|Change in Berg balance between baseline and 3 months was compared between the two groups.||||||0.3||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.30
74059614|NCT03728257|147672221|SUPERIORITY|Change in Berg balance between baseline and 3 months was compared between the two groups.||||||0.81||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.81
74059615|NCT03728257|147672222|SUPERIORITY|Change in 30 Second Sit-to-Stand Test between baseline and 3 months was compared between the two groups.||||||0.2262||||||a priori threshold for statistical significance is p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.2262
74059616|NCT03728257|147672223|SUPERIORITY|Change in 30 Second Sit-to-Stand Test between baseline and 6 months was compared between the two groups.||||||0.59||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.59
74059617|NCT03728257|147672224|SUPERIORITY|Change in SGRQ between baseline and 3 months was compared between the two groups.||||||0.26||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.26
74059618|NCT03728257|147672225|SUPERIORITY|Change in SGRQ between baseline and 6 months was compared between the two groups.||||||0.78||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.78
74059619|NCT03728257|147672226|SUPERIORITY|Change in MVPA between baseline and 3 months was compared between the two groups.||||||0.7073||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.7073
74059620|NCT03728257|147672227|SUPERIORITY|Change in MVPA between baseline and 6 months was compared between the two groups.||||||0.313||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.313
74059621|NCT03728257|147672228|SUPERIORITY|Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.||||||0.91||||||a priori threshold for statistical significance p \< 0.05|Chi-squared|||||||0.91
74059622|NCT03728257|147672229|SUPERIORITY|Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.||||||0.72||||||a priori threshold of statistical significance p \< 0.05|Chi-squared|||||||0.72
74059623|NCT00903409|147672279|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The difference between Non-switchers and Switchers in the percent change in non-HDL-C level from the end of the OM6 double-blind study (average of Weeks 6 and 8 for the statistical analysis) to 4 months of OM6X open-label treatment (Month 4).|Kruskal-Wallis|||||||<0.001
74059624|NCT01516684|147672287|OTHER|||||||0.036|||||||T-test and chi-square|||Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate for the outcome. GEE methods will be used when analyzing the percentage of times additional propofol was administered. Mixed model regression methods will be used when analyzing the total dose administered.||||0.036
74059625|NCT01516684|147672289|OTHER|Marginal mixed model (GEE type)||||||0.094|||||||Mixed Models Analysis|||||||0.094
74059626|NCT01516684|147672290|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
74059627|NCT01516684|147672291|OTHER|Marginal mixed model (GEE type)||||||0.426|||||||Mixed Models Analysis|||||||0.426
74059628|NCT02262507|147672377|OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
74059629|NCT00975000|147672507|SUPERIORITY_OR_OTHER||Chi-Square test statistic|66.437|||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by baseline corrected total serum calcium level (≤ 11.2 mg/dL and \> 11.2 mg/dL)||The primary endpoint was tested at a significance level of 0.05.||||<0.001
74059630|NCT00975000|147672507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|91.41|||||TWO_SIDED|95.0|18.76|445.41|||||Odds ratio of Cinacalcet/Placebo|||445.41|18.76|
74101854|NCT03569293|147753915|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|15.0|||<|0.001|TWO_SIDED|95.0|10.4|19.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||19.6|10.4|<0.001
74101855|NCT03569293|147753916|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-45.98|STANDARD_ERROR_OF_MEAN|6.549|<|0.001|TWO_SIDED|95.0|-58.82|-33.15|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.15|-58.82|<0.001
74059631|NCT00975000|147672507|SUPERIORITY_OR_OTHER||Difference|75.44|||||TWO_SIDED|95.0|63.83|87.05|||||Difference = Cinacalcet-Placebo|||87.05|63.83|
74059632|NCT00975000|147672508|SUPERIORITY_OR_OTHER||Difference|1.41||||0.266|TWO_SIDED|95.0|-1.1|3.93|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the percent change in BMD between the 2 treatment groups (cinacalcet - placebo)|||3.93|-1.10|0.266
74059633|NCT00975000|147672509|SUPERIORITY_OR_OTHER||Difference|0.45|||<|0.001|TWO_SIDED|95.0|0.26|0.64|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean serum phosphorus between the 2 treatment groups (cinacalcet - placebo)|||0.64|0.26|<0.001
74059634|NCT00975000|147672510|SUPERIORITY_OR_OTHER||Difference|-0.4||||0.842|TWO_SIDED|95.0|-4.37|3.57|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean eGFR between the 2 treatment groups (cinacalcet - placebo)|||3.57|-4.37|0.842
74059635|NCT00975000|147672511|SUPERIORITY_OR_OTHER||Difference|-1.39|||<|0.001|TWO_SIDED|95.0|-1.62|-1.16|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in corrected total calcium between the 2 treatment groups (cinacalcet - placebo)|||-1.16|-1.62|<0.001
74059636|NCT00975000|147672512|SUPERIORITY_OR_OTHER||Difference|-117.21||||0.002|TWO_SIDED|95.0|-189.88|-44.55|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in iPTH between the 2 treatment groups (cinacalcet - placebo)|||-44.55|-189.88|0.002
74059637|NCT00975000|147672513|SUPERIORITY_OR_OTHER||Difference|-1.42||||0.846|TWO_SIDED|95.0|-15.91|13.06|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in urine phosphorus between the 2 treatment groups (cinacalcet - placebo)|||13.06|-15.91|0.846
74059638|NCT00902486|147672518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0619|TWO_SIDED|95.0|0.77|6.15|||Cochran-Armitage trend test||LOGISTIC regression model for odds ratio estimates : LOGIT(Response 0/1) = Treatment + Biologics|The prespecified primary analysis for ACR 20 was the Cochran-Armitage trend test looking for a dose-response relationship. The treatment effect was also assessed using a logistic regression model including background therapy (more than 8 weeks of biologics or not) and treatment.||6.15|0.77|0.0619
74059639|NCT00902486|147672518|OTHER|||||||0.1978|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 4 mg QD versus placebo.||||0.1978
74059640|NCT00902486|147672518|OTHER|||||||0.0437|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 7 mg QD versus placebo.||||0.0437
74059641|NCT00902486|147672518|OTHER|||||||0.1236|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 10 mg QD versus placebo.||||0.1236
74059642|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated||1.4|-1.4|
74059643|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.7||||||95.0|-4.8|3.3||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥26.00 EU/mL) threshold was calculated||3.3|-4.8|
73881895|NCT05108246|147297641|SUPERIORITY|||||||0.001||||||P-value is calculated.|Wilcoxon (Mann-Whitney)|||Change in balance was assessed by calculating a change score between pre-test and end point scores for balance. Change scores were then compared using Mann-Whitney U test and reported as Median (Interquartile range).||||.001
74059644|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated||1.4|-1.4|
74059645|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-6.4|1.7||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥36.00 EU/mL) threshold was calculated||1.7|-6.4|
74059646|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥7.82 EU/mL) threshold was calculated||1.4|-1.4|
74059647|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated||2.7|-1.7|
74059648|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.1||||||95.0|-1.4|6.8||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (17.00 EU/mL) threshold was calculated||6.8|-1.4|
74059649|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated||2.7|-1.7|
74059650|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (7.82 EU/mL) threshold was calculated||2.7|-1.7|
73881896|NCT05108246|147297641|SUPERIORITY|||||||0.003||||||P-value is calculated.|Wilcoxon (Mann-Whitney)|||Change in balance was assessed by calculating a change score between pre-test and end point scores for balance. Change scores were then compared using Mann-Whitney U test and reported as Median (Interquartile range).||||.003
74059651|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-3.0||||||95.0|-8.0|2.5||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (75.00 EU/mL) threshold was calculated||2.5|-8.0|
74059652|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-8.0||||||95.0|-14.9|-1.2||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||-1.2|-14.9|
74059653|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||1.4|-1.4|
74059654|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.7||||||95.0|-3.7|9.2||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||9.2|-3.7|
74059655|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.5|1.5||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||1.5|-1.5|
74059656|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8||||||95.0|-3.1|1.8||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||1.8|-3.1|
74059657|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||2.7|-1.7|
74059658|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-5.8|1.8||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||1.8|-5.8|
74059659|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||2.7|-1.7|
74059660|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-7.6|3.0||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.0|-7.6|
74101856|NCT03569293|147753916|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-36.74|||<|0.001|TWO_SIDED|95.0|-49.66|-23.81|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-23.81|-49.66|<0.001
74059661|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.3||||||95.0|-11.4|2.6||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||2.6|-11.4|
74059662|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.3||||||95.0|-5.0|4.3||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||4.3|-5.0|
74059663|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.5||||||95.0|-3.6|3.5||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.5|-3.6|
74059664|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.5||||||95.0|-3.1|3.0||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.0|-3.1|
74059665|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8||||||95.0|-3.1|1.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||1.9|-3.1|
74059666|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.9||||||95.0|-3.2|5.0||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated||5.0|-3.2|
74059667|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.5||||||95.0|-13.2|4.4||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated||4.4|-13.2|
74059668|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.8||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated||2.8|-1.7|
74059669|NCT00366678|147672605|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.2||||||95.0|-3.1|4.5||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated||4.5|-3.1|
74059670|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.9|-1.7|
74059671|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.9||||||95.0|-0.9|4.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.9|-0.9|
74059672|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 4 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.1|-4.9|
74059673|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.8|-1.8|
74059674|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|1.4||||||95.0|-1.1|5.9||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.9|-1.1|
74059675|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-5.8|2.7||||||For serotype 6B the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.7|-5.8|
74059676|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.9|-1.7|
74059677|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.8|3.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||3.3|-1.8|
74059678|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.3|3.0||||||For serotype 9V the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.0|-3.3|
74059679|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|-0.4||||||95.0|-2.5|2.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.4|-2.5|
74059680|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-1.8|4.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.4|-1.8|
74059681|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 14 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.1|-4.9|
74059682|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.8|-1.8|
74059683|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|1.3||||||95.0|-1.1|5.7||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.7|-1.1|
74059684|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|-1.0||||||95.0|-5.5|2.8||||||For serotype 18C the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.8|-5.5|
74059685|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.2||||||95.0|-3.1|4.7||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||4.7|-3.1|
74059686|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-2.9|5.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.4|-2.9|
74059687|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|-0.3||||||95.0|-5.5|4.4||||||For serotype 19F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||4.4|-5.5|
74059688|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.9||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.9|-1.8|
74059689|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-1.9|4.4||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.4|-1.9|
74059690|NCT00366678|147672606|SUPERIORITY_OR_OTHER||Difference|-0.1||||||95.0|-4.1|3.7||||||For serotype 23F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.7|-4.1|
74059691|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.87||||||95.0|0.73|1.03||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.03|0.73|
74059692|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.83||||||95.0|0.67|1.03||||||For serotype 4 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.03|0.67|
74059693|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|1.04||||||95.0|0.86|1.26||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.26|0.86|
74059694|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.77|1.13||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.13|0.77|
74059695|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|1.07||||||95.0|0.82|1.4||||||For serotype 6B after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.40|0.82|
74059696|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.87||||||95.0|0.69|1.1||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.10|0.69|
74059697|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.8||||||95.0|0.68|0.94||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.94|0.68|
74059698|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.71||||||95.0|0.59|0.85||||||For serotype 9V after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.85|0.59|
74059699|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|1.13||||||95.0|0.95|1.33||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.33|0.95|
74059700|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.88||||||95.0|0.73|1.06||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.06|0.73|
74059701|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.72||||||95.0|0.58|0.9||||||For serotype 14 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.90|0.58|
74059702|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|1.22||||||95.0|1.0|1.49||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.49|1.00|
74059703|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.82||||||95.0|0.69|0.97||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.97|0.69|
74059704|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.86||||||95.0|0.69|1.08||||||For serotype 18C after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.08|0.69|
74059705|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.78|1.15||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.15|0.78|
74059706|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|1.26||||||95.0|1.0|1.59||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.59|1.00|
74059707|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.91||||||95.0|0.68|1.2||||||For serotype 19F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.20|0.68|
74101857|NCT03569293|147753917|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-47.03|STANDARD_ERROR_OF_MEAN|2.716|<|0.001|TWO_SIDED|95.0|-52.37|-41.7|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-41.70|-52.37|<0.001
74101858|NCT03569293|147753917|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-39.53|STANDARD_ERROR_OF_MEAN|2.738|<|0.001|TWO_SIDED|95.0|-44.91|-34.15|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-34.15|-44.91|<0.001
74101859|NCT03569293|147753918|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|58.6|||<|0.001|TWO_SIDED|95.0|51.9|65.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||65.3|51.9|<0.001
74059708|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|1.39||||||95.0|1.08|1.79||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.79|1.08|
74059709|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.81||||||95.0|0.67|1.0||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.00|0.67|
74059710|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.85||||||95.0|0.67|1.07||||||For serotype 23F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.07|0.67|
74059711|NCT00366678|147672607|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.78|1.19||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.19|0.78|
74059712|NCT00366678|147672610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.66|0.9||||||For Diphtheria the GMC ratio was calculated||0.90|0.66|
74059713|NCT00366678|147672610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.08||||||For Tetanus the GMC ratio was calculated||1.08|0.82|
74059714|NCT00366678|147672610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.8||||||95.0|0.67|0.97||||||For Diphtheria the GMC ratio was calculated||0.97|0.67|
74059715|NCT00366678|147672610|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Tetanus the GMC ratio was calculated||1.08|0.69|
74059716|NCT00366678|147672611|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.73|1.14||||||For Hib (PRP) the GMC ratio was calculated||1.14|0.73|
74059717|NCT00366678|147672611|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.04||||||95.0|0.82|1.32||||||For Hib (PRP) the GMC ratio was calculated||1.32|0.82|
74059718|NCT00366678|147672612|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.71|1.09||||||For Polio Type 1 the GMC ratio was calculated||1.09|0.71|
74059719|NCT00366678|147672612|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.66|1.03||||||For Polio Type 2 the GMC ratio was calculated||1.03|0.66|
74059720|NCT00366678|147672612|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.59|1.02||||||For Polio Type 3 the GMC ratio was calculated||1.02|0.59|
74059721|NCT00366678|147672612|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.72|1.41||||||For Polio Type 1 the GMC ratio was calculated||1.41|0.72|
73881897|NCT00718510|147297648|OTHER||||||<|0.05||||||General Psychopathology Subscale Score|ANOVA|F(1,11)=5.03||Null hypothesis is that there was no difference in change of PANSS between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time). A sample size of 14 patients was needed to give 90% power to detect a 4 point difference on the PANSS. This included a drop-out rate of about 10%.||||<0.05
74059722|NCT00366678|147672612|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.72|1.34||||||For Polio Type 2 the GMC ratio was calculated||1.34|0.72|
74059723|NCT00366678|147672612|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.84||||||95.0|0.6|1.17||||||For Polio Type 3 the GMC ratio was calculated||1.17|0.60|
74059724|NCT00366678|147672613|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.78|0.98||||||For Pertussis - FHA the GMC ratio was calculated||0.98|0.78|
74059725|NCT00366678|147672613|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.92||||||95.0|0.84|1.02||||||For Pertussis - PT the GMC ratio was calculated||1.02|0.84|
74059726|NCT00366678|147672613|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.72|1.0||||||For Pertussis - FHA the GMC ratio was calculated||1.00|0.72|
74059727|NCT00366678|147672613|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.86|1.14||||||For Pertussis - PT the GMC ratio was calculated||1.14|0.86|
74059728|NCT03292731|147672632|OTHER||Odds Ratio (OR)|1.0||||0.96|TWO_SIDED|95.0|0.93|1.08||adjusted for cerclage|Regression, Logistic|adjusted for cerclage||logistic regression comparing drug concentration to the rate of sPTB||1.08|0.93|0.96
74059729|NCT03292731|147672633|OTHER||Slope|1.11||||0.05|TWO_SIDED|95.0|0.0|2.23|||Regression, Linear|||||2.23|0.00|0.05
74059730|NCT03292731|147672634|OTHER||Slope|1.56||||0.022|TWO_SIDED|95.0|0.25|2.87|||Regression, Linear|||||2.87|0.25|0.022
74059731|NCT03292731|147672635|SUPERIORITY|||||||0.82||||||no adjustments|Fisher Exact|||Only RCT subjects utilized in neonatal safety analysis||||0.82
74059732|NCT01965431|147672639|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is the maximum acceptable extent of statistical and clinical noninferiority of an experimental treatment. Non-inferiority margin for this trial is 10ms.|Mean Difference (Net)|7.9|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|5.37|10.43|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|||10.43|5.37|
74059733|NCT01965431|147672640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.7|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|90.0|9.32|16.08|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||16.08|9.32|
74059734|NCT01965431|147672641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|-1.38|1.73|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||1.73|-1.38|
74059735|NCT01965431|147672642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.42|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|-5.98|-2.87|||||Minimum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||-2.87|-5.98|
74059736|NCT01803464|147672653|OTHER||Cohen's d|0.59|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled Standard Deviation (SD) of the % change for the 2 groups was the denominator.|||||
74059737|NCT01803464|147672653|OTHER||Cohen's d|0.13|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
74059738|NCT01803464|147672653|OTHER||Cohen's d|0.51|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing control group group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
74059739|NCT01803464|147672654|OTHER||Cohen's d|0.45|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator|||||
74059740|NCT01803464|147672654|OTHER||Cohen's d|0.57|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
74059741|NCT01803464|147672654|OTHER||Cohen's d|0.13|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator|||||
74059742|NCT01803464|147672655|OTHER||Cohen's d|1.2|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
74059743|NCT01803464|147672655|OTHER||Cohen's d|0.33|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
74059744|NCT01803464|147672655|OTHER||Cohen's d|0.33|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing control group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
74059745|NCT02424851|147672656|OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
74059746|NCT02424851|147672657|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
74059747|NCT02424851|147672658|OTHER||||||=|0.48|||||||Fisher Exact|||Statistical analysis of SAEs.||||=0.48
74059748|NCT02424851|147672658|OTHER||||||=|0.25|||||||Fisher Exact|||Statistical analysis of AEs||||=0.25
74059749|NCT02424851|147672659|OTHER||||||=|0.31|||||||Log Rank|||||||= 0.31
74059750|NCT02424851|147672660|OTHER||||||=|0.45|||||||Fisher Exact|||||||=0.45
74059751|NCT02424851|147672661|OTHER|||||||0.33|||||||t-test, 1 sided|||||||0.33
74059752|NCT01360021|147672670|SUPERIORITY_OR_OTHER||Estimated Geometic Mean Ratio|1.1||||0.001|TWO_SIDED|95.0|1.06|1.14|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|Symbicort AC pMDI 2x160/4.5 µg bid vs Budesonide AC pMDI 2x160 µg bid|The comparison of Symbicort AC pMDI 2x160/4.5 µg bid with budesonide AC pMDI 2x160 µg bid for post dose FEV1||1.14|1.06|0.001
74059753|NCT01360021|147672670|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.97|1.05|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid for post dose FEV1.||1.05|0.97|
74059754|NCT01360021|147672671|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.99|1.08|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid, for pre-dose FEV1.||1.08|0.99|
74059755|NCT01360021|147672672|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were be made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.49|STANDARD_ERROR_OF_MEAN|6.75||0.825|TWO_SIDED|95.0|-11.81|14.8|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid||14.80|-11.81|0.825
74059756|NCT01360021|147672672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.52|STANDARD_ERROR_OF_MEAN|6.8||0.001|TWO_SIDED|95.0|20.11|46.93|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid minus Budesonide AC pMDI 2x160 µg bid||46.93|20.11|0.001
74059757|NCT01360021|147672672|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|6.15||0.81|TWO_SIDED|95.0|-10.66|13.61|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||13.61|-10.66|0.810
74059758|NCT01360021|147672672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.25|STANDARD_ERROR_OF_MEAN|6.21||0.001|TWO_SIDED|95.0|20.01|44.49|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid and Budesonide AC pMDI 2x160 µg bid.||44.49|20.01|0.001
74101860|NCT03569293|147753918|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|52.3|||<|0.001|TWO_SIDED|95.0|45.2|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.4|45.2|<0.001
74059759|NCT01360021|147672673|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.272|TWO_SIDED|95.0|-0.1|0.35|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||0.35|-0.10|0.272
74059760|NCT01360021|147672674|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.69||0.025|TWO_SIDED|95.0|-11.41|-0.79|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||-0.79|-11.41|0.025
74059761|NCT01360021|147672675|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.23||0.258|TWO_SIDED|95.0|-0.19|0.71|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between BAI Symbicort BA MDI 2x160/4.5 μg bid and pMDI Symbicort AC pMDI 2x160/4.5 µg bid.||0.71|-0.19|0.258
74101861|NCT03569293|147753919|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|53.2|||<|0.001|TWO_SIDED|95.0|45.9|60.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.5|45.9|<0.001
74101862|NCT03569293|147753919|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|46.7|||<|0.001|TWO_SIDED|95.0|39.0|54.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||54.4|39.0|<0.001
74101863|NCT03569293|147753920|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-40.39|STANDARD_ERROR_OF_MEAN|2.732|<|0.001|TWO_SIDED|95.0|-45.75|-35.03|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-35.03|-45.75|<0.001
74101864|NCT03569293|147753920|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-33.03|STANDARD_ERROR_OF_MEAN|2.758|<|0.001|TWO_SIDED|95.0|-38.44|-27.61|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-27.61|-38.44|<0.001
74101865|NCT03569293|147753921|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|24.8|45.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.1|24.8|<0.001
74101866|NCT03569293|147753921|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|21.4|41.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||41.6|21.4|<0.001
74059762|NCT02446496|147672676|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|95.91|||||TWO_SIDED|90.0|85.67|107.37||||||||107.37|85.67|
74059763|NCT02446496|147672677|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|102.31|||||TWO_SIDED|90.0|90.46|115.7|||||Comparison of AUC (0-t) between Treatment A and Treatment B|||115.70|90.46|
74059764|NCT02446496|147672677|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|103.13|||||TWO_SIDED|90.0|91.19|116.62|||||Comparison of AUC(0-infinity) between Treatment A and Treatment B|||116.62|91.19|
73888217|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8||||0.6014|TWO_SIDED|95.0|-60.6|104.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||104.3|-60.6|0.6014
74059765|NCT02446496|147672678|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Wilcoxon's Signed-Rank Test|Comparison of T-max between Treatment A and Treatment B.||||||0.2670
74059766|NCT03170271|147672694|SUPERIORITY|The null hypothesis was that the exacerbation rate of benralizumab was equal to the exacerbation rate of placebo.|Rate ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.65|||Negative binomial|||Comparison of annual exacerbation rates for benralizumab vs placebo (rate ratio). Treatment group, region, number of exacerbations in previous year and maintenance OCS use at baseline were included in the negative binomial model as covariates. The log of each patient's corresponding follow-up time was used as an offset variable in the model to adjust for patients having different follow-up times during which events occurred.||0.65|0.39|<0.0001
74059767|NCT03170271|147672695|SUPERIORITY||LS Mean difference|-8.11|||<|0.0001|TWO_SIDED|95.0|-11.41|-4.82|||Repeated measures analysis||Model: Change from baseline in SGRQ total score = Treatment + baseline SGRQ total score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SGRQ total score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a mixed-effect model for repeated measures (MMRM) analysis.||-4.82|-11.41|<0.0001
74059768|NCT03170271|147672696|SUPERIORITY||LS Mean difference|0.16|||<|0.0001|TWO_SIDED|95.0|0.09|0.23|||Repeated measures analysis||Model: Change from baseline in pre-BD FEV1 = Treatment + baseline pre-BD FEV1 + region + number of exacerbations in previous year + maintenance OCS use at baseline + gender + age + visit + treatment by visit.|Change from baseline in pre-BD FEV1 at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||0.23|0.09|<0.0001
74059769|NCT03170271|147672697|SUPERIORITY||LS Mean difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.27|||Repeated measures analysis||Model: Change from baseline in ACQ-6 score = Treatment + baseline ACQ-6 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in ACQ-6 score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.27|-0.65|<0.0001
74059770|NCT03170271|147672698|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.67|||Regression, Cox||A hazard ratio \< 1 favours benralizumab to be associated with a longer time from randomization to the first exacerbation than placebo.|Comparison of time to first asthma exacerbation for benralizumab vs placebo. Treatment group, region, number of exacerbations in previous year and maintenance OCS use at baseline were included in the Cox proportional hazard model as covariates.||0.67|0.40|<0.0001
74059771|NCT03170271|147672699|SUPERIORITY||LS Mean difference|20.11||||0.0031|TWO_SIDED|95.0|6.79|33.44|||Repeated measures analysis||Model: Change from baseline in PEF = Treatment + baseline PEF + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from run-in baseline in morning PEF at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||33.44|6.79|0.0031
74059772|NCT03170271|147672699|SUPERIORITY||LS Mean Difference|23.09||||0.0008|TWO_SIDED|95.0|9.62|36.55|||Repeated measures analysis||Model: Change from baseline in PEF = Treatment + baseline PEF + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from run-in baseline in evening PEF at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||36.55|9.62|0.0008
74059773|NCT03170271|147672700|SUPERIORITY||LS Mean difference|5.35||||0.0077|TWO_SIDED|95.0|1.42|9.28|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for physical functioning at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||9.28|1.42|0.0077
74059774|NCT03170271|147672700|SUPERIORITY||LS Mean Difference|6.8||||0.0022|TWO_SIDED|95.0|2.45|11.14|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for role limitations due to physical health at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||11.14|2.45|0.0022
74059775|NCT03170271|147672700|SUPERIORITY||LS Mean Difference|3.07||||0.1741|TWO_SIDED|95.0|-1.36|7.5|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for bodily pain at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||7.50|-1.36|0.1741
74059776|NCT03170271|147672700|SUPERIORITY||LS Mean Difference|5.62||||0.0009|TWO_SIDED|95.0|2.32|8.92|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for general health perceptions at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||8.92|2.32|0.0009
74059777|NCT03170271|147672700|SUPERIORITY||LS Mean Difference|5.51||||0.0025|TWO_SIDED|95.0|1.95|9.08|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for vitality at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||9.08|1.95|0.0025
74059778|NCT03170271|147672700|SUPERIORITY||LS Mean Difference|3.12||||0.1583|TWO_SIDED|95.0|-1.22|7.46|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for social functioning at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||7.46|-1.22|0.1583
74059779|NCT03170271|147672700|SUPERIORITY||LS Mean Difference|2.44||||0.2103|TWO_SIDED|95.0|-1.38|6.27|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for role limitations due to emotional problems at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||6.27|-1.38|0.2103
74059780|NCT03170271|147672700|SUPERIORITY||LS Mean Difference|1.68||||0.2581|TWO_SIDED|95.0|-1.23|4.59|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for mental health at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||4.59|-1.23|0.2581
74059781|NCT03170271|147672700|SUPERIORITY||LS Mean Difference|2.32||||0.0022|TWO_SIDED|95.0|0.84|3.81|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 physical health component summary score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||3.81|0.84|0.0022
74059782|NCT03170271|147672700|SUPERIORITY||LS Mean Difference|0.87||||0.2751|TWO_SIDED|95.0|-0.7|2.44|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 mental health component summary score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||2.44|-0.70|0.2751
74059783|NCT03170271|147672701|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0233|TWO_SIDED|95.0|1.06|2.25|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + baseline score + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a responder classified as type 'Improvement' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.25|1.06|0.0233
74059784|NCT03170271|147672701|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0401|TWO_SIDED|95.0|1.02|2.16|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + baseline score + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a responder classified as type 'Important Improvement' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.16|1.02|0.0401
74059785|NCT03170271|147672702|SUPERIORITY||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.47|2.86|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a CGI-C responder classified as type 'Much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.86|1.47|<0.0001
74059786|NCT03170271|147672702|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0003|TWO_SIDED|95.0|1.77|6.7|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a CGI-C responder classified as type 'Very much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||6.70|1.77|0.0003
74101867|NCT03569293|147753922|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|37.3|||<|0.001|TWO_SIDED|95.0|30.8|43.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.8|30.8|<0.001
73881898|NCT00718510|147297649|OTHER|||||||0.46|||||||ANOVA|||Null hypothesis is that there was no difference in change of CGI ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).||||0.46
73881899|NCT00718510|147297650|OTHER|||||||0.55|||||||ANOVA|||Null hypothesis is that there was no difference in change of CDSS ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).||||0.55
73881900|NCT00117637|147297661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.5|TWO_SIDED|95.0|0.61|1.27||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%||1.27|0.61|0.50
73881901|NCT00117637|147297662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.469|TWO_SIDED|95.0|0.628|1.239||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%||1.239|0.628|0.469
73881902|NCT00117637|147297663|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||The Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel|||||||0.006
73881903|NCT00117637|147297664|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||the Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel|||||||0.0004
74059787|NCT03170271|147672702|SUPERIORITY||Odds Ratio (OR)|2.06|||<|0.0001|TWO_SIDED|95.0|1.48|2.87|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a PGI-C responder classified as type 'Much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.87|1.48|<0.0001
74059788|NCT03170271|147672702|SUPERIORITY||Odds Ratio (OR)|3.02|||<|0.0001|TWO_SIDED|95.0|2.02|4.51|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a PGI-C responder classified as type 'Very much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||4.51|2.02|<0.0001
74059789|NCT03170271|147672703|SUPERIORITY||LS Mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.62|-0.68|||Repeated measures analysis||Model: Change from baseline in average PSIA score (top 3 ranked) =Treatment + baseline average PSIA score (top 3 ranked) + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in PSIA severity score for the average of top 3 ranked symptoms/impairments at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.68|-1.62|<0.0001
74059790|NCT03170271|147672703|SUPERIORITY||LS Mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.64|-0.66|||Repeated measures analysis||Model: Change from baseline in PSIA score (top ranked) =Treatment + baseline PSIA score (top ranked) + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in PSIA severity score of top ranked symptom/impairment at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.66|-1.64|<0.0001
74059791|NCT03170271|147672704|SUPERIORITY||LS Mean difference|-8.91||||0.0204|TWO_SIDED|95.0|-16.42|-1.4|||Repeated measures analysis||Model: Change from baseline in SNOT-22 total score = Treatment + baseline SNOT-22 total score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SNOT-22 total score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-1.40|-16.42|0.0204
74059792|NCT03123120|147672720|OTHER||Risk Difference (RD)|-0.232|||||TWO_SIDED|95.0|-0.568|0.118|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.118|-0.568|
74059793|NCT03123120|147672721|OTHER||Risk Difference (RD)|-0.054|||||TWO_SIDED|95.0|-0.404|0.21|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.210|-0.404|
74059794|NCT03123120|147672722|OTHER||Risk Difference (RD)|-0.286|||||TWO_SIDED|95.0|-0.602|0.101|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.101|-0.602|
74059795|NCT03123120|147672723|OTHER||Risk Difference (RD)|0.143|||||TWO_SIDED|95.0|-0.197|0.399|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.399|-0.197|
74059796|NCT00203892|147672725|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.028
74059797|NCT00203892|147672726|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||||||>0.99
74059798|NCT00806416|147672727|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and the 70 mg alendronate market tablet, the GMR of the combination tablet/alendronate only tablet are contained within \[0.80,1.25\].|Least square mean ratio|1.03||||||90.0|0.91|1.17||||||If the true geometric mean ratio (GMR) for total urinary excretion of alendronate of 70 mg alendronate/vitamin D3 combination tablet with respect to alendronate alone is 1.00 then a sample size =208 provided 99% probability of yielding a 90% CI for the total urinary excretion GMR within the interval of \[0.80, 1.25\]. These calculations were based on the observed-pooled within-subject standard deviation (log scale) of 0.521 obtained from earlier Phase 1 studies.||1.17|0.91|
74059799|NCT00806416|147672728|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within \[0.80,1.25\].|Least square mean ratio for AUC0-120 hr|0.88||||||90.0|0.81|0.95||||||If the true GMRs for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample size=28 provided \>99% probability of yielding a 90% CI for both AUC(0-120 hr) and Cmax GMRs within the interval of \[0.80, 1.25\]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC(0-120 hr) (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.||0.95|0.81|
74101868|NCT03569293|147753922|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|25.9|||<|0.001|TWO_SIDED|95.0|19.7|32.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||32.1|19.7|<0.001
74101869|NCT03569293|147753923|SUPERIORITY||Adjusted Response Rate Difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||79.4|53.8|<0.001
74101870|NCT03569293|147753923|SUPERIORITY||Adjusted Response Rate Difference|62.0|||<|0.001|TWO_SIDED|95.0|48.6|75.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||75.4|48.6|<0.001
74101871|NCT03569293|147753924|SUPERIORITY||Adjusted Response Rate Difference|57.4|||<|0.001|TWO_SIDED|95.0|44.6|70.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.2|44.6|<0.001
74101872|NCT03569293|147753924|SUPERIORITY||Adjusted Response Rate Difference|39.1|||<|0.001|TWO_SIDED|95.0|25.6|52.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||52.6|25.6|<0.001
74101873|NCT03569293|147753925|SUPERIORITY||Adjusted Response Rate Difference|46.6|||<|0.001|TWO_SIDED|95.0|32.6|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.6|32.6|<0.001
74101874|NCT03569293|147753925|SUPERIORITY||Adjusted Response Rate Difference|38.7|||<|0.001|TWO_SIDED|95.0|24.3|53.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.1|24.3|<0.001
74101875|NCT03569293|147753926|SUPERIORITY||Adjusted Response Rate Difference|63.9|||<|0.001|TWO_SIDED|95.0|51.8|75.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||75.9|51.8|<0.001
74101876|NCT03569293|147753926|SUPERIORITY||Adjusted Response Rate Difference|43.8|||<|0.001|TWO_SIDED|95.0|30.9|56.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||56.7|30.9|<0.001
74101877|NCT03569293|147753927|SUPERIORITY||Adjusted Response Rate Difference|54.7|||<|0.001|TWO_SIDED|95.0|41.7|67.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.8|41.7|<0.001
74101878|NCT03569293|147753927|SUPERIORITY||Adjusted Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|32.0|58.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||58.3|32.0|<0.001
74101879|NCT03569293|147753928|SUPERIORITY||Adjusted Response Rate Difference|47.1|||<|0.001|TWO_SIDED|95.0|34.0|60.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.2|34.0|<0.001
74101880|NCT03569293|147753928|SUPERIORITY||Adjusted Response Rate Difference|35.9|||<|0.001|TWO_SIDED|95.0|23.2|48.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.6|23.2|<0.001
74101881|NCT03569293|147753929|SUPERIORITY||Adjusted Response Rate Difference|21.0|||<|0.001|TWO_SIDED|95.0|11.0|31.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||31.1|11.0|<0.001
74101882|NCT03569293|147753929|SUPERIORITY||Adjusted Response Rate Difference|9.4||||0.008|TWO_SIDED|95.0|2.5|16.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||16.4|2.5|0.008
74101883|NCT03569293|147753930|SUPERIORITY||Adjusted Response Rate Difference|11.0||||0.015|TWO_SIDED|95.0|2.1|19.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||19.9|2.1|0.015
74101884|NCT03569293|147753930|SUPERIORITY||Adjusted Response Rate Difference|6.5||||0.086|TWO_SIDED|95.0|-0.9|13.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||13.9|-0.9|0.086
74101885|NCT03569293|147753931|SUPERIORITY||Adjusted Response Rate Difference|10.8||||0.045|TWO_SIDED|95.0|0.2|21.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.4|0.2|0.045
74101886|NCT03569293|147753931|SUPERIORITY||Adjusted Response Rate Difference|11.0||||0.04|TWO_SIDED|95.0|0.5|21.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.5|0.5|0.040
74101887|NCT03569293|147753932|SUPERIORITY||Adjusted Response Rate Difference|-22.1|||<|0.001|TWO_SIDED|95.0|-32.6|-11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-11.5|-32.6|<0.001
74101888|NCT03569293|147753932|SUPERIORITY||Adjusted Response Rate Difference|-22.1|||<|0.001|TWO_SIDED|95.0|-32.7|-11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-11.5|-32.7|<0.001
73881904|NCT00117637|147297666|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.||||0.022
74101889|NCT03569293|147753933|SUPERIORITY||Adjusted Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|37.7|69.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.4|37.7|<0.001
74101890|NCT03569293|147753933|SUPERIORITY||Adjusted Response Rate Difference|34.8|||<|0.001|TWO_SIDED|95.0|18.1|51.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||51.4|18.1|<0.001
74101891|NCT03569293|147753934|SUPERIORITY||Adjusted Response Rate Difference|56.6|||<|0.001|TWO_SIDED|95.0|42.0|71.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.1|42.0|<0.001
74101892|NCT03569293|147753934|SUPERIORITY||Adjusted Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|16.9|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.1|16.9|<0.001
74101893|NCT03569293|147753935|SUPERIORITY||Adjusted Response Rate Difference|50.9|||<|0.001|TWO_SIDED|95.0|35.1|66.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.7|35.1|<0.001
74101894|NCT03569293|147753935|SUPERIORITY||Adjusted Response Rate Difference|35.7|||<|0.001|TWO_SIDED|95.0|18.8|52.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||52.6|18.8|<0.001
74059800|NCT00806416|147672729|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within \[0.80,1.25\].|least-squares mean for Cmax|0.89||||||90.0|0.84|0.95||||||If the true GMR ratios for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample of N=28 provided \>99% probability of yielding a 90% CI for both AUC0-120 hr and Cmax GMRs within the interval of \[0.80, 1.25\]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC0-120 hr (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.||0.95|0.84|
74059801|NCT01244516|147672741|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|97.4|-5.91|6.7|||Mixed Models Analysis|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP - AOA.|This comparison is between galyfilcon and lotrafilcon B. Ho: galyfilcon A -lotrafilcon B \<= -5. Ha: galyfilcon A - lotrafilcon B \> -5.||6.70|-5.91|
74101895|NCT03569293|147753936|SUPERIORITY||Adjusted Response Rate Difference|54.4|||<|0.001|TWO_SIDED|95.0|37.4|71.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.3|37.4|<0.001
74101896|NCT03569293|147753936|SUPERIORITY||Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|19.8|56.4|||Chi-squared, Corrected|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||56.4|19.8|<0.001
74101897|NCT03569293|147753937|SUPERIORITY||Adjusted Response Rate Difference|51.2|||<|0.001|TWO_SIDED|95.0|33.3|69.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.1|33.3|<0.001
74101898|NCT03569293|147753937|SUPERIORITY||Adjusted Response Rate Difference|28.1||||0.006|TWO_SIDED|95.0|8.0|48.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.2|8.0|0.006
74101899|NCT03569293|147753938|SUPERIORITY||Adjusted Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|19.9|42.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||42.5|19.9|<0.001
74101900|NCT03569293|147753938|SUPERIORITY||Adjusted Response Rate Difference|15.8||||0.001|TWO_SIDED|95.0|6.9|24.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||24.6|6.9|0.001
74101901|NCT03569293|147753939|SUPERIORITY||LS Mean Difference|-42.42|||<|0.001|TWO_SIDED|95.0|-56.16|-28.68|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-28.68|-56.16|<0.001
74101902|NCT03569293|147753939|SUPERIORITY||LS Mean Difference|-33.88|||<|0.001|TWO_SIDED|95.0|-47.76|-19.99|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-19.99|-47.76|<0.001
74101903|NCT03569293|147753940|SUPERIORITY||LS Mean Difference|-41.84|||<|0.001|TWO_SIDED|95.0|-52.09|-31.58|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-31.58|-52.09|<0.001
73881905|NCT00117637|147297668|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.||||0.015
74059802|NCT01244516|147672741|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|97.4|-5.96|6.79|||Mixed Models Analysis|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP - BIO.|This comparison is between galyfilcon A and comfilcon A. Ho: gayfilcon A- comfilcon A \<= -5. Ha: galyfilcon A- comfilcon A\> -5.||6.79|-5.96|
74059803|NCT01244516|147672742|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at \> 0.75. Superiority is concluded is the 97.4% CL \> 1.|Odds Ratio (OR)|1.66|||||TWO_SIDED|97.4|1.14|2.44|||Regression, Logistic|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP/AOA.|The comparison is between galyfilcon A (AAHP) and lotrafilcon B (AOA) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/AOA). Ha: OR \> 1 for (AAHP/AOA).||2.44|1.14|
74059804|NCT01244516|147672742|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at \> 0.75. Superiority is concluded is the 97.4% CL \> 1.|Odds Ratio (OR)|1.66|||||TWO_SIDED|97.4|1.14|2.44|||Regression, Logistic|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.||The comparison is between galyfilcon A (AAHP) and comfilcon A (BIO) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/BIO). Ha: OR \> 1 for (AAHP/BIO).||2.44|1.14|
74059805|NCT03359473|147672775|OTHER||Mean Difference (Net)|4.53|||||TWO_SIDED|90.0|-1.3|10.36|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||10.36|-1.30|
74059806|NCT03359473|147672775|OTHER||Mean Difference (Net)|7.8|||||TWO_SIDED|90.0|0.83|14.76|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||14.76|0.83|
74059807|NCT03359473|147672776|OTHER||Mean Difference (Net)|16.71|||||TWO_SIDED|90.0|9.86|23.56|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||23.56|9.86|
74059808|NCT03359473|147672776|OTHER||Mean Difference (Net)|5.35|||||TWO_SIDED|90.0|-4.09|14.78|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||14.78|-4.09|
74059809|NCT03359473|147672777|OTHER||Mean Difference (Net)|5.17|||||TWO_SIDED|90.0|-4.67|15.01|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||15.01|-4.67|
74059810|NCT03359473|147672777|OTHER||Mean Difference (Net)|7.02|||||TWO_SIDED|90.0|0.46|13.58|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||13.58|0.46|
74059811|NCT03359473|147672778|OTHER||Mean Difference (Net)|5.9|||||TWO_SIDED|90.0|-1.4|13.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||13.2|-1.4|
74059812|NCT03359473|147672778|OTHER||Mean Difference (Net)|13.5|||||TWO_SIDED|90.0|1.6|25.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||25.5|1.6|
74059813|NCT03359473|147672779|OTHER||Mean Difference (Net)|20.7|||||TWO_SIDED|90.0|10.1|31.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||31.2|10.1|
74059814|NCT03359473|147672779|OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|90.0|-11.1|25.8|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||25.8|-11.1|
74059815|NCT03359473|147672780|OTHER||Mean Difference (Net)|8.0|||||TWO_SIDED|90.0|-2.5|18.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||18.4|-2.5|
74059816|NCT03359473|147672780|OTHER||Mean Difference (Net)|11.8|||||TWO_SIDED|90.0|-0.5|24.0|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||24.0|-0.5|
74059817|NCT03359473|147672781|OTHER||Mean Difference (Net)|0.882|||||TWO_SIDED|90.0|0.643|1.121|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.121|0.643|
74059818|NCT03359473|147672781|OTHER||Mean Difference (Net)|0.291|||||TWO_SIDED|90.0|-0.156|0.738|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||0.738|-0.156|
74059819|NCT03359473|147672782|OTHER||Mean Difference (Net)|0.982|||||TWO_SIDED|90.0|0.629|1.334|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.334|0.629|
74059820|NCT03359473|147672782|OTHER||Mean Difference (Net)|1.127|||||TWO_SIDED|90.0|0.682|1.571|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.571|0.682|
74101904|NCT03569293|147753940|SUPERIORITY||LS Mean Difference|-37.84|||<|0.001|TWO_SIDED|95.0|-48.17|-27.52|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-27.52|-48.17|<0.001
74101905|NCT03569293|147753941|SUPERIORITY||Adjusted Response Rate Difference|54.8|||<|0.001|TWO_SIDED|95.0|40.3|69.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.4|40.3|<0.001
74101906|NCT03569293|147753941|SUPERIORITY||Adjusted Response Rate Difference|50.0|||<|0.001|TWO_SIDED|95.0|34.8|65.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||65.3|34.8|<0.001
74059821|NCT03359473|147672783|OTHER||Mean Difference (Net)|1.38|||||TWO_SIDED|90.0|0.964|1.795|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.795|0.964|
74059822|NCT03359473|147672783|OTHER||Mean Difference (Net)|1.124|||||TWO_SIDED|90.0|0.594|1.654|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.654|0.594|
74059823|NCT03359473|147672784|OTHER||Mean Difference (Net)|1.167|||||TWO_SIDED|90.0|0.677|1.658|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||1.658|0.677|
74059824|NCT03359473|147672784|OTHER||Mean Difference (Net)|0.923|||||TWO_SIDED|90.0|0.222|1.623|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||1.623|0.222|
74059825|NCT03359473|147672785|OTHER||Mean Difference (Net)|2.085|||||TWO_SIDED|90.0|1.493|2.678|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.678|1.493|
74059826|NCT03359473|147672785|OTHER||Mean Difference (Net)|1.7|||||TWO_SIDED|90.0|0.801|2.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.600|0.801|
74059827|NCT03359473|147672786|OTHER||Mean Difference (Net)|2.108|||||TWO_SIDED|90.0|1.271|2.945|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.945|1.271|
74059828|NCT03359473|147672786|OTHER||Mean Difference (Net)|2.113|||||TWO_SIDED|90.0|0.949|3.277|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||3.277|0.949|
74059829|NCT03359473|147672787|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.6|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.6|
74059830|NCT03359473|147672787|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.4|0.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.5|-0.4|
74059831|NCT03359473|147672788|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.6|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.6|
74059832|NCT03359473|147672788|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|90.0|-0.2|0.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.9|-0.2|
74059833|NCT03359473|147672789|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|90.0|-0.4|0.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.9|-0.4|
74059834|NCT03359473|147672789|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|90.0|-0.5|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.5|
74059835|NCT03359473|147672790|OTHER||Mean Difference (Net)|-0.553|||||TWO_SIDED|90.0|-2.082|0.977|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.977|-2.082|
74059836|NCT03359473|147672790|OTHER||Mean Difference (Net)|-0.073|||||TWO_SIDED|90.0|-0.977|0.832|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.832|-0.977|
74101907|NCT03569293|147753942|SUPERIORITY||Adjusted Response Rate Difference|45.1|||<|0.001|TWO_SIDED|95.0|21.0|69.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.2|21.0|<0.001
74101908|NCT03569293|147753942|SUPERIORITY||Adjusted Response Rate Difference|49.6|||<|0.001|TWO_SIDED|95.0|26.7|72.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.5|26.7|<0.001
74101909|NCT03569293|147753943|SUPERIORITY||LS Mean Difference|-38.92|||<|0.001|TWO_SIDED|95.0|-49.54|-28.31|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-28.31|-49.54|<0.001
74101910|NCT03569293|147753943|SUPERIORITY||LS Mean Difference|-32.7|||<|0.001|TWO_SIDED|95.0|-43.44|-21.96|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-21.96|-43.44|<0.001
74101911|NCT03569293|147753944|SUPERIORITY||Adjusted Response Rate Difference|51.7|||<|0.001|TWO_SIDED|95.0|31.7|71.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.8|31.7|<0.001
74101912|NCT03569293|147753944|SUPERIORITY||Adjusted Response Rate Difference|44.7|||<|0.001|TWO_SIDED|95.0|26.7|62.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||62.8|26.7|<0.001
74101913|NCT03569293|147753945|SUPERIORITY||Adjusted Response Rate Difference|25.1||||0.006|TWO_SIDED|95.0|7.3|43.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.0|7.3|0.006
74059837|NCT03359473|147672791|OTHER||Mean Difference (Net)|-0.816|||||TWO_SIDED|90.0|-2.252|0.619|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.619|-2.252|
74059838|NCT03359473|147672791|OTHER||Mean Difference (Net)|0.163|||||TWO_SIDED|90.0|-1.096|1.422|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||1.422|-1.096|
74101914|NCT03569293|147753945|SUPERIORITY||Adjusted Response Rate Difference|15.8||||0.093|TWO_SIDED|95.0|-2.6|34.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||34.2|-2.6|0.093
74101915|NCT02038842|147753976|OTHER|The co-primary immunogenicity endpoint is analysed per arm, in a frequentist framework, in all randomised participants having received at least one vaccine administration and still HIV-negative at W30.|||||=|0.02||||||One-sided test for the observed proportion being superior to the theoretical decision threshold of 50%.|Binomial|||Trial was designed to compare the observed proportion of responders at week 30 within each group to a predefined minimum immunogenicity level of 50%.||||=0.02
74101916|NCT03412773|147753981|NON_INFERIORITY|"Overall survival (OS) was compared between the tislelizumab group (Arm A) and the sorafenib group (Arm B) by testing the null hypothesis of noninferiority: the null hypothesis assumes the hazard ratio (HR) for tislelizumab versus sorafenib is greater than or equal to 1.08, while the alternative hypothesis assumes the hazard ratio is less than 1.08.~Noninferiority was declared if the upper limit of the 95.003% confidence interval (CI) for the HR was less than 1.08"|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.003|0.712|1.019|||||The hazard ratio is based on a Cox regression model with treatment, geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG (0 vs. 1) as covariates.|||1.019|0.712|
74101917|NCT03412773|147753981|SUPERIORITY|Superiority of tislelizumab over sorafenib was tested for OS using a stratified log-rank test in the ITT analysis set only when noninferiority was demonstrated. Superiority was declared if the one-sided p-value crosses the boundary of 0.0223 (1-sided p-value \< 0.0223) in favor of Arm A in the stratified log-rank test.|Hazard Ratio (HR)|0.85||||0.0398|TWO_SIDED|95.0|0.712|1.019||One sided Log-Rank Test stratified by geography (Asia vs EU/US), macrovascular invasion and/or extrahepatic spread (present vs. absent), etiology (HCV vs. Other) and ECOG (0 vs. 1).|Log Rank||The hazard ratio was derived from a Cox regression model with treatment as a covariate and stratified by geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG score (0 vs. 1).|||1.019|0.712|0.0398
74101918|NCT03412773|147753982|OTHER||Cochran-Mantel-Haenszel ORR difference|8.28||||0.0003|TWO_SIDED|95.0|3.85|12.7||The nominal P-value from the Cochran-Mantel-Haenszel chi-square test, conducted at a 0.05 significance level, was stratified by geography, macrovascular invasion/extrahepatic spread, etiology, and ECOG.|Cochran-Mantel-Haenszel|||The null hypothesis assumed that ORR is equal in both groups, while the alternative hypothesis assumed ORR is higher in the tislelizumab group (Arm A).||12.70|3.85|0.0003
74101919|NCT03412773|147753983|OTHER||Cochran-Mantel-Haenszel ORR difference|9.24|||<|0.0001|TWO_SIDED|95.0|4.71|13.78||The nominal P-value from the Cochran-Mantel-Haenszel chi-square test, conducted at a 0.05 significance level, was stratified by geography, macrovascular invasion/extrahepatic spread, etiology, and ECOG.|Cochran-Mantel-Haenszel|||||13.78|4.71|<0.0001
74101920|NCT03412773|147753984|OTHER||Hazard Ratio (HR)|1.11||||0.1364|TWO_SIDED|95.0|0.92|1.33||One sided Log-Rank Test stratified by geography (Asia vs EU/US), macrovascular invasion and/or extrahepatic spread (present vs. absent), etiology (HCV vs. Other) and ECOG (0 vs. 1).|One-sided log-rank test||The hazard ratio was derived from a Cox regression model with treatment as a covariate and stratified by geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG score (0 vs. 1).|||1.33|0.92|0.1364
74101921|NCT03412773|147753985|OTHER||Hazard Ratio (HR)|1.06||||0.2622|TWO_SIDED|95.0|0.9|1.26||One sided Log-Rank Test stratified by geography (Asia vs EU/US), macrovascular invasion and/or extrahepatic spread (present vs. absent), etiology (HCV vs. Other) and ECOG (0 vs. 1).|One-sided log-rank test||The hazard ratio was derived from a Cox regression model with treatment as a covariate and stratified by geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG score (0 vs. 1).|||1.26|0.90|0.2622
74101922|NCT03412773|147753988|OTHER||Hazard Ratio (HR)|1.14||||0.0859|TWO_SIDED|95.0|0.94|1.38||One sided Log-Rank Test stratified by geography (Asia vs EU/US), macrovascular invasion and/or extrahepatic spread (present vs. absent), etiology (HCV vs. Other) and ECOG (0 vs. 1).|One-sided log-rank test||The hazard ratio was derived from a Cox regression model with treatment as a covariate and stratified by geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG score (0 vs. 1).|||1.38|0.94|0.0859
74101923|NCT03412773|147753989|OTHER||Hazard Ratio (HR)|1.12||||0.1182|TWO_SIDED|95.0|0.94|1.34||One sided Log-Rank Test stratified by geography (Asia vs EU/US), macrovascular invasion and/or extrahepatic spread (present vs. absent), etiology (HCV vs. Other) and ECOG (0 vs. 1).|One-sided log-rank test||The hazard ratio was derived from a Cox regression model with treatment as a covariate and stratified by geography (Asia vs. EU/US), macrovascular invasion/extrahepatic spread (present vs. absent), etiology (HCV vs. other), and ECOG score (0 vs. 1).|||1.34|0.94|0.1182
74101924|NCT03412773|147753995|OTHER||Least Squares (LS) Mean Difference|-2.3||||0.0033|TWO_SIDED|95.0|-3.8|-0.8||Reported p-values are nominal.|Mixed Models Analysis|||Between-arm differences in the change from Baseline were assessed using a mixed model for repeated measures. The model included Baseline scores, stratification factors, treatment arms, visits, and treatment arm by visit interaction as fixed effects and visit as a repeated measure with an unstructured covariance matrix based on the missing at random assumption.||-0.8|-3.8|0.0033
74101925|NCT03412773|147753996|OTHER||LS Mean Difference|-2.7||||0.0096|TWO_SIDED|95.0|-4.7|-0.7||Reported p-values are nominal.|Mixed Models Analysis|||Between-arm differences in the change from Baseline were assessed using a mixed model for repeated measures. The model included Baseline scores, stratification factors, treatment arms, visits, and treatment arm by visit interaction as fixed effects and visit as a repeated measure with an unstructured covariance matrix based on the missing at random assumption.||-0.7|-4.7|0.0096
74101926|NCT03412773|147753997|OTHER||LS Mean Difference|4.3||||0.0037|TWO_SIDED|95.0|1.4|7.3||Reported p-values are nominal.|Mixed Models Analysis|||Between-arm differences in the change from Baseline were assessed using a mixed model for repeated measures. The model included Baseline scores, stratification factors, treatment arms, visits, and treatment arm by visit interaction as fixed effects and visit as a repeated measure with an unstructured covariance matrix based on the missing at random assumption.||7.3|1.4|0.0037
74101927|NCT03412773|147753998|OTHER||LS Mean Difference|5.0||||0.0022|TWO_SIDED|95.0|1.8|8.2||Reported p-values are nominal.|Mixed Models Analysis|||Between-arm differences in the change from Baseline were assessed using a mixed model for repeated measures. The model included Baseline scores, stratification factors, treatment arms, visits, and treatment arm by visit interaction as fixed effects and visit as a repeated measure with an unstructured covariance matrix based on the missing at random assumption.||8.2|1.8|0.0022
74101928|NCT05646719|147754016|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.01|TWO_SIDED|95.0|1.23|4.2|||t-test, 2 sided|||||4.20|1.23|<0.01
74101929|NCT05646719|147754016|SUPERIORITY||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0||||||||||||
74101930|NCT05332912|147754022|SUPERIORITY||||||=|0.066|||||||t-test, 1 sided|df = 26||Null Hypothesis: Participants with Down Syndrome will exhibit no change in number of correct items in Mental Rotation performance following 8 weeks of experiential training.||||=.066
74101931|NCT05332912|147754022|SUPERIORITY||||||=|0.056|||||||t-test, 1 sided|||Null Hypothesis: Amount of change in Mental Rotation performance following 8 weeks of experiential training will not differ for participants with Down Syndrome who received 8 weeks of experiential intervention and Typically Developing Children in the Delayed Intervention who had not received 8 weeks of intervention.||||=.056
74101932|NCT05332912|147754022|SUPERIORITY||||||=|0.65|||||||t-test, 2 sided|df = 55||Null Hypothesis: Amount of change in Mental Rotation performance following 8 weeks of experiential training will not differ for Typically Developing Children Immediate Intervention and Down Syndrome Participants Immediate intervention.||||=.65
74101933|NCT05332912|147754023|SUPERIORITY||||||=|0.039|||||||t-test, 1 sided|||Null Hypothesis: Participants with Down Syndrome will exhibit no change in number of correct items in Mental Rotation performance following 16 weeks of experiential training.||||=.039
74101934|NCT05332912|147754023|SUPERIORITY||||||=|0.32|||||||t-test, 2 sided|df = 48||Null Hypothesis: Participants with Down Syndrome in the Immediate Intervention condition and received 16 weeks of experiential training in Mental Rotation will exhibit a similar change in performance as Typically Developing Children in the Delayed Intervention condition who received only 8 weeks of experiential training.||||= .32
74101935|NCT05332912|147754023|SUPERIORITY||||||=|0.73||||||df = 55|t-test, 2 sided|||Null Hypothesis: Amount of change in Mental Rotation performance following 16 weeks of experiential training will not differ for Typically Developing Children Immediate Intervention and Down Syndrome Participants Immediate intervention.||||=.73
74101936|NCT05332912|147754024|SUPERIORITY||||||=|0.023|||||||t-test, 1 sided|df = 26||Null Hypothesis: Participants with Down Syndrome will exhibit no change in Perspective Taking performance following 8 weeks of experiential training.||||=.023
74101937|NCT05332912|147754024|SUPERIORITY|||||||0.23|||||||t-test, 1 sided|df = 48||Null Hypothesis: Amount of change in Perspective Taking performance following 8 weeks of experiential training will not differ for participants with Down Syndrome who received 8 weeks of experiential intervention and Typically Developing Children in the Delayed Intervention who had not received 8 weeks of intervention.||||.23
74101938|NCT05332912|147754024|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|df = 55||Null Hypothesis: Amount of change in Mental Rotation will not differ for participants with Down Syndrome in the Immediate Intervention Condition who received 8 weeks of experiential intervention and Typically Developing Children in the Immediate Intervention who also received 8 weeks of intervention.||||.42
74101939|NCT05332912|147754025|SUPERIORITY||||||=|0.01|||||||t-test, 1 sided|df = 26||Null Hypothesis: Participants with Down Syndrome will exhibit no change in Perspective Taking performance following 16 weeks of experiential training.||||=.01
74101940|NCT05332912|147754025|SUPERIORITY||||||=|0.28|||||||t-test, 2 sided|df = 48||Null Hypothesis: Amount of change in Perspective Taking will not differ for participants with Down Syndrome in the Immediate Intervention Condition who received16 weeks of experiential intervention and Typically Developing Children in the Delayed Intervention condition who received 8 weeks of intervention.||||=.28
74101941|NCT05332912|147754025|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|df = 55||Null Hypothesis: Amount of change in Perspective Taking will not differ for participants with Down Syndrome in the Immediate Intervention Condition who received16 weeks of experiential intervention and Typically Developing Children in the Immediate Intervention who also received 16 weeks of intervention.||||.23
74101942|NCT01546987|147754032|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.55|TWO_SIDED|95.0|0.47|1.48||One-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|Revised protocol due to early accrual closure (September 2014) computes that seventy events with five years of additional follow-up after early accrual closure provides 70% power (at one-sided alpha = 0.05) to detect a 40% reduction in the assumed rate control arm rate of is 0.08/year.||1.48|0.47|0.55
74101943|NCT01546987|147754033|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.27|TWO_SIDED|95.0|0.38|1.31||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|Revised protocol due to early accrual closure (September 2014) computes that 5-year survival of 78% and annual hazard rate of 0.055 for ADT + RT arm, with five years of additional follow-up after early accrual closure provides 28% power (at two-sided alpha = 0.05) to detect a 33% reduction in failure rate.||1.31|0.38|0.27
74101944|NCT01546987|147754034|SUPERIORITY||Hazard Ratio (HR)|2.29|||<|0.001|TWO_SIDED|95.0|1.54|3.4|||Log Rank||Reference level = ADT + RT arm|||3.40|1.54|<0.001
74101945|NCT01546987|147754035|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.33|3.13|||Log Rank|||||3.13|0.33|0.99
74059839|NCT03359473|147672792|OTHER||Mean Difference (Net)|-0.96|||||TWO_SIDED|90.0|-2.668|0.748|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.748|-2.668|
74059840|NCT03359473|147672792|OTHER||Mean Difference (Net)|-1.937|||||TWO_SIDED|90.0|-5.208|1.333|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||1.333|-5.208|
74059841|NCT03359473|147672793|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|90.0|-0.314|0.233|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.233|-0.314|
74059842|NCT03359473|147672793|OTHER||Mean Difference (Net)|0.058|||||TWO_SIDED|90.0|-0.209|0.324|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.324|-0.209|
74059843|NCT03359473|147672794|OTHER||Mean Difference (Net)|-0.287|||||TWO_SIDED|90.0|-0.65|0.077|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.077|-0.650|
74059844|NCT03359473|147672794|OTHER||Mean Difference (Net)|-0.191|||||TWO_SIDED|90.0|-0.534|0.152|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.152|-0.534|
74059845|NCT03359473|147672795|OTHER||Mean Difference (Net)|-0.012|||||TWO_SIDED|90.0|-0.555|0.532|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.532|-0.555|
74059846|NCT03359473|147672795|OTHER||Mean Difference (Net)|-0.231|||||TWO_SIDED|90.0|-0.541|0.08|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.080|-0.541|
74059847|NCT03359473|147672796|OTHER||Difference in Least Square Means|11.1|||||TWO_SIDED|90.0|-57.1|79.2|||||Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.|||79.2|-57.1|
74059848|NCT03359473|147672796|OTHER||Difference in Least Square Means|-149.3|||||TWO_SIDED|90.0|-280.6|-18.1|||||Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.|||-18.1|-280.6|
74059849|NCT03359473|147672797|OTHER||Difference in Least Square Means|-6.7|||||TWO_SIDED|90.0|-42.7|29.2|||||Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.|||29.2|-42.7|
74059850|NCT03359473|147672797|OTHER||Difference in Least Square Means|-34.8|||||TWO_SIDED|90.0|-72.0|2.4|||||Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.|||2.4|-72.0|
74059851|NCT03359473|147672798|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|90.0|-2.6|1.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||1.9|-2.6|
74059852|NCT03359473|147672798|OTHER||Mean Difference (Net)|-0.7|||||TWO_SIDED|90.0|-3.4|2.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||2.1|-3.4|
74059853|NCT03359473|147672799|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|90.0|-2.9|1.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||1.1|-2.9|
74059854|NCT03359473|147672799|OTHER||Mean Difference (Net)|2.2|||||TWO_SIDED|90.0|0.0|4.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||4.5|0.0|
74059855|NCT03359473|147672800|OTHER||Mean Difference (Net)|-4.7|||||TWO_SIDED|90.0|-8.9|-0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||-0.6|-8.9|
74059856|NCT03359473|147672800|OTHER||Mean Difference (Net)|-2.1|||||TWO_SIDED|90.0|-7.2|3.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||3.1|-7.2|
74059857|NCT03359473|147672801|OTHER||Mean Difference (Net)|-4.9|||||TWO_SIDED|90.0|-9.5|-0.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||-0.4|-9.5|
74059858|NCT03359473|147672801|OTHER||Mean Difference (Net)|-4.1|||||TWO_SIDED|90.0|-10.3|2.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||2.2|-10.3|
74059859|NCT03359473|147672802|OTHER||Mean Difference (Net)|-3.1|||||TWO_SIDED|90.0|-5.9|-0.3|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||-0.3|-5.9|
74059860|NCT03359473|147672802|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|90.0|-4.6|4.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||4.2|-4.6|
74059861|NCT03359473|147672803|OTHER||Mean Difference (Net)|4.0|||||TWO_SIDED|90.0|-0.8|8.8|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||8.8|-0.8|
74059862|NCT03359473|147672803|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|90.0|-2.3|9.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||9.4|-2.3|
74059863|NCT03359473|147672804|OTHER||Mean Difference (Net)|-4.2|||||TWO_SIDED|90.0|-6.5|-1.9|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||-1.9|-6.5|
73881906|NCT00117637|147297670|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.073
73881907|NCT00117637|147297672|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.067
73881908|NCT00117637|147297673|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.005
74059864|NCT03359473|147672804|OTHER||Mean Difference (Net)|-1.5|||||TWO_SIDED|90.0|-4.1|1.1|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||1.1|-4.1|
74059865|NCT03359473|147672805|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|90.0|-3.8|1.8|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||1.8|-3.8|
74059866|NCT03359473|147672805|OTHER||Mean Difference (Net)|-0.7|||||TWO_SIDED|90.0|-4.6|3.2|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||3.2|-4.6|
74059867|NCT03359473|147672810|OTHER||Difference in Least Square Means|3.0|||||TWO_SIDED|90.0|-1.4|7.4|||||Analysis was performed by ANCOVA model with Baseline total score as the covariate adjusting for the treatment.|||7.4|-1.4|
74059868|NCT03359473|147672810|OTHER||Difference in Least Square Means|2.1|||||TWO_SIDED|90.0|-2.3|6.5|||||Analysis was performed by ANCOVA model with Baseline total score as the covariate adjusting for the treatment.|||6.5|-2.3|
74059869|NCT03359473|147672811|OTHER||Difference in Least Square Means|2.6|||||TWO_SIDED|90.0|-5.0|10.1|||||Analysis was performed by ANCOVA model with Baseline symptoms score as the covariate adjusting for the treatment.|||10.1|-5.0|
74059870|NCT03359473|147672811|OTHER||Difference in Least Square Means|-0.5|||||TWO_SIDED|90.0|-8.4|7.5|||||Analysis was performed by ANCOVA model with Baseline symptoms score as the covariate adjusting for the treatment.|||7.5|-8.4|
74059871|NCT03359473|147672812|OTHER||Difference in Least Square Means|2.0|||||TWO_SIDED|90.0|-3.2|7.1|||||Analysis was performed by ANCOVA model with Baseline activity score as the covariate adjusting for the treatment.|||7.1|-3.2|
74059872|NCT03359473|147672812|OTHER||Difference in Least Square Means|0.5|||||TWO_SIDED|90.0|-5.6|6.5|||||Analysis was performed by ANCOVA model with Baseline activity score as the covariate adjusting for the treatment.|||6.5|-5.6|
74059873|NCT03359473|147672813|OTHER||Difference in Least Square Means|3.4|||||TWO_SIDED|90.0|-1.7|8.6|||||Analysis was performed by ANCOVA model with Baseline impact score as the covariate adjusting for the treatment.|||8.6|-1.7|
74059874|NCT03359473|147672813|OTHER||Difference in Least Square Means|3.5|||||TWO_SIDED|90.0|-0.7|7.7|||||Analysis was performed by ANCOVA model with Baseline impact score as the covariate adjusting for the treatment.|||7.7|-0.7|
74059875|NCT05302414|147672818|SUPERIORITY||Median Difference (Final Values)|12.75|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
74059876|NCT05302414|147672818|SUPERIORITY||Median Difference (Final Values)|2.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
74059877|NCT05302414|147672818|SUPERIORITY||Median Difference (Final Values)|6.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
73881909|NCT00117637|147297674|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.001
73881910|NCT00117637|147297675|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.019
74059878|NCT05302414|147672819|SUPERIORITY||Median Difference (Final Values)|1.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For pretest at the 0 week||||<0.05
74059879|NCT05302414|147672819|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
74059880|NCT05302414|147672819|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
74059881|NCT05302414|147672820|SUPERIORITY||Median Difference (Final Values)|40.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
74059882|NCT05302414|147672820|SUPERIORITY||Median Difference (Final Values)|45.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
74059883|NCT05302414|147672820|SUPERIORITY||Median Difference (Final Values)|43.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
74059884|NCT05302414|147672821|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
74059885|NCT05302414|147672821|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
74059886|NCT05302414|147672821|SUPERIORITY||Median Difference (Final Values)|2.5||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
74059887|NCT05302414|147672822|SUPERIORITY||Median Difference (Final Values)|6.75|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
73881911|NCT00117637|147297684|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Log Rank|||||||0.014
73881912|NCT04864249|147297717|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
73881913|NCT04864249|147297718|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
73881914|NCT04864249|147297719|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
73881915|NCT04864249|147297720|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
73881916|NCT04864249|147297721|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
73881917|NCT04864249|147297722|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
73881918|NCT04864249|147297723|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
73881919|NCT04864249|147297724|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
73881920|NCT04864249|147297725|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
73881921|NCT04864249|147297726|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
74101946|NCT01546987|147754036|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.48|TWO_SIDED|95.0|0.29|1.75||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT arm|Revised protocol due to early accrual closure (September 2014) computes that 5-year survival of 78% and annual hazard rate of 0.02 for ADT + RT arm, with five years of additional follow-up after early accrual closure provides 32% power (at two-sided alpha = 0.05) to detect a 50% reduction in failure rate.||1.75|0.29|0.48
74101947|NCT01546987|147754037|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.65|TWO_SIDED|95.0|0.45|1.63||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|||1.63|0.45|0.65
74101948|NCT01546987|147754039|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.76
74101949|NCT01546987|147754040|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||\[Bowel domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.44
74101950|NCT01546987|147754040|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||\[Urinary domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.13
74101951|NCT01546987|147754040|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||\[Sexual domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.50
74101952|NCT01546987|147754040|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||\[Hormonal domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.96
74101953|NCT01546987|147754051|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0104|TWO_SIDED|95.0|0.29|0.89|||Log Rank||Reference arm = ADT + RT arm|||0.89|0.29|0.0104
74101954|NCT05381948|147754054|OTHER||Least Square (LS) Mean|-0.12|STANDARD_ERROR_OF_MEAN|1.199||0.919|TWO_SIDED|95.0|-2.48|2.24|||Mixed Model for Repeated Measures (MMRM)|||||2.24|-2.48|0.919
74101955|NCT05381948|147754054|OTHER||LS Mean|-0.31|STANDARD_ERROR_OF_MEAN|1.187||0.795|TWO_SIDED|95.0|-2.63|2.02|||MMRM|||||2.02|-2.63|0.795
74101956|NCT02942004|147754076|SUPERIORITY||Least Square (LS) Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|1.664||0.0013|TWO_SIDED|95.0|-8.8|-2.2|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.20|-8.80|0.0013
74101957|NCT02942004|147754076|SUPERIORITY||LS mean difference|-3.68|STANDARD_ERROR_OF_MEAN|1.622||0.0252|TWO_SIDED|95.0|-6.9|-0.47|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.47|-6.90|0.0252
74101958|NCT02942004|147754077|SUPERIORITY||LS mean difference|-5.63|STANDARD_ERROR_OF_MEAN|1.936||0.0044|TWO_SIDED|95.0|-9.46|-1.79|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.79|-9.46|0.0044
74101959|NCT02942004|147754077|SUPERIORITY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|1.899||0.0481|TWO_SIDED|95.0|-7.56|-0.03|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-7.56|0.0481
74101960|NCT02942004|147754078|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.951||0.9591|TWO_SIDED|95.0|-1.83|1.93|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.93|-1.83|0.9591
74101961|NCT02942004|147754078|SUPERIORITY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.917||0.8677|TWO_SIDED|95.0|-1.66|1.97|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.97|-1.66|0.8677
74101962|NCT02942004|147754078|SUPERIORITY||LS mean difference|-2.11|STANDARD_ERROR_OF_MEAN|1.208||0.0827|TWO_SIDED|95.0|-4.51|0.28|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-4.51|0.0827
74101963|NCT02942004|147754078|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.172||0.7968|TWO_SIDED|95.0|-2.62|2.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.02|-2.62|0.7968
73881922|NCT04864249|147297727|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
73881923|NCT04864249|147297728|SUPERIORITY|||||||0.66|||||||Chi-squared|||||||0.66
73881924|NCT04864249|147297729|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
73881925|NCT04864249|147297730|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
73881926|NCT04864249|147297731|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||||||0.56
73881927|NCT04864249|147297732|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
73881928|NCT04864249|147297733|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
73881929|NCT04864249|147297734|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
73881930|NCT04864249|147297735|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
73881931|NCT04864249|147297736|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
74101964|NCT02942004|147754078|SUPERIORITY||LS mean difference|-2.04|STANDARD_ERROR_OF_MEAN|1.336||0.1292|TWO_SIDED|95.0|-4.69|0.61|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.61|-4.69|0.1292
74101965|NCT02942004|147754078|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|1.299||0.7801|TWO_SIDED|95.0|-2.94|2.21|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.21|-2.94|0.7801
74101966|NCT02942004|147754078|SUPERIORITY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|1.436||0.384|TWO_SIDED|95.0|-4.1|1.59|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.59|-4.10|0.3840
74101967|NCT02942004|147754078|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.395||0.6097|TWO_SIDED|0.71|-2.05|3.48|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.48|-2.05|0.6097
74101968|NCT02942004|147754078|SUPERIORITY||LS mean difference|-4.28|STANDARD_ERROR_OF_MEAN|1.622||0.0094|TWO_SIDED|95.0|-7.5|-1.07|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.07|-7.50|0.0094
74101969|NCT02942004|147754078|SUPERIORITY||LS mean difference|-2.32|STANDARD_ERROR_OF_MEAN|1.577||0.144|TWO_SIDED|95.0|-5.45|0.8|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.80|-5.45|0.1440
74101970|NCT02942004|147754078|SUPERIORITY||LS mean difference|-5.12|STANDARD_ERROR_OF_MEAN|1.62||0.002|TWO_SIDED|95.0|-8.33|-1.91|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.91|-8.33|0.0020
74101971|NCT02942004|147754078|SUPERIORITY||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|1.572||0.3906|TWO_SIDED|95.0|-4.47|1.76|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.76|-4.47|0.3906
74101972|NCT02942004|147754078|SUPERIORITY||LS mean difference|-4.49|STANDARD_ERROR_OF_MEAN|1.735||0.011|TWO_SIDED|95.0|-7.93|-1.05|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.05|-7.93|0.0110
74101973|NCT02942004|147754078|SUPERIORITY||LS mean difference|-3.33|STANDARD_ERROR_OF_MEAN|1.69||0.0511|TWO_SIDED|95.0|-6.68|0.02|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-6.68|0.0511
74101974|NCT02942004|147754078|SUPERIORITY||LS mean difference|-5.02|STANDARD_ERROR_OF_MEAN|1.738||0.0046|TWO_SIDED|95.0|-8.47|-1.58|||MMRM|||Change at hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.58|-8.47|0.0046
74101975|NCT02942004|147754078|SUPERIORITY||LS mean difference|-2.53|STANDARD_ERROR_OF_MEAN|1.694||0.1389|TWO_SIDED|95.0|-5.88|0.83|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.83|-5.88|0.1389
73881932|NCT04864249|147297737|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
73881933|NCT04864249|147297738|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
73881934|NCT04864249|147297739|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
73881935|NCT04864249|147297740|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
73881936|NCT04864249|147297741|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
73881937|NCT04864249|147297742|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
73881938|NCT04864249|147297743|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
73881939|NCT04864249|147297744|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
73881940|NCT04864249|147297745|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
73881941|NCT04864249|147297746|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
73881942|NCT04864249|147297747|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
74059888|NCT05302414|147672822|SUPERIORITY||Median Difference (Final Values)|0.25||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
74059889|NCT05302414|147672822|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
74059890|NCT05302414|147672823|SUPERIORITY||Median Difference (Final Values)|22.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||<0.05
74059891|NCT01610284|147672824|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.67|0.89|||Log Rank|||FAS-Full population||0.89|0.67|<0.001
74059892|NCT01610284|147672824|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.8||||0.003|TWO_SIDED|95.0|0.68|0.94|||Log Rank|||FAS-Main cohort||0.94|0.68|0.003
74059893|NCT01610284|147672824|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.76||||0.015|TWO_SIDED|95.0|0.6|0.97|||Log Rank|||FAS-PI3K pathway activated||0.97|0.60|0.015
74059894|NCT01610284|147672824|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.03||||||FAS-PI3K pathway non-activated||1.03|0.67|
74059895|NCT01610284|147672824|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.52|0.94||||||FAS-PI3K pathway unknown||0.94|0.52|
74059896|NCT01610284|147672825|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.87||||0.045|TWO_SIDED|95.0|0.74|1.02|||Log Rank|||FAS-Full population||1.02|0.74|0.045
74101976|NCT02942004|147754078|SUPERIORITY||LS mean difference|-4.07|STANDARD_ERROR_OF_MEAN|1.837||0.0288|TWO_SIDED|95.0|-7.71|-0.43|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.43|-7.71|0.0288
74101977|NCT02942004|147754078|SUPERIORITY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.797||0.3799|TWO_SIDED|95.0|-5.15|1.98|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.98|-5.15|0.3799
74101978|NCT02942004|147754078|SUPERIORITY||LS mean difference|-2.92|STANDARD_ERROR_OF_MEAN|2.139||0.1747|TWO_SIDED|95.0|-7.16|1.32|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.32|-7.16|0.1747
74101979|NCT02942004|147754078|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|2.08||0.631|TWO_SIDED|95.0|-5.13|3.12|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.12|-5.13|0.6310
74101980|NCT02942004|147754078|SUPERIORITY||LS mean difference|-4.92|STANDARD_ERROR_OF_MEAN|2.045||0.0178|TWO_SIDED|95.0|-8.98|-0.87|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.87|-8.98|0.0178
74101981|NCT02942004|147754078|SUPERIORITY||LS mean difference|-3.51|STANDARD_ERROR_OF_MEAN|1.976||0.0786|TWO_SIDED|95.0|-7.43|0.41|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.41|-7.43|0.0786
74101982|NCT02942004|147754079|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0052|TWO_SIDED|95.0|1.7|17.4|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||17.4|1.7|0.0052
74059897|NCT01610284|147672825|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.91||||0.144|TWO_SIDED|95.0|0.75|1.09|||Log Rank|||FAS-Main cohort||1.09|0.75|0.144
74059898|NCT01610284|147672825|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.61|1.08||||||FAS-PI3K pathway activated||1.08|0.61|
74059899|NCT01610284|147672825|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.77|1.24||||||FAS-PI3K pathway non-activated||1.24|0.77|
74059900|NCT01610284|147672825|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.06||||||FAS-PI3K pathway unknown||1.06|0.52|
74059901|NCT04035694|147672833|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.41|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.41
74059902|NCT04035694|147672834|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.11
74059903|NCT04035694|147672835|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.54|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.54
74059904|NCT04035694|147672836|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.38|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.38
74059905|NCT04035694|147672837|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.56|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.56
74059906|NCT04035694|147672838|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.09|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.09
74059907|NCT04035694|147672839|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.40
73881943|NCT04864249|147297748|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
73881944|NCT04864249|147297749|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
73881945|NCT04864249|147297750|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
73881946|NCT04864249|147297751|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
74059908|NCT04035694|147672840|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.74|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.74
74059909|NCT04035694|147672841|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.07||0.66|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.66
74059910|NCT04035694|147672842|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.78|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.78
74059911|NCT04035694|147672843|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.52|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.52
74059912|NCT04035694|147672844|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.74|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.74
74059913|NCT04035694|147672845|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.13||0.21|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.21
74059914|NCT04035694|147672846|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.27|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.27
74059915|NCT04035694|147672847|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
74059916|NCT04035694|147672848|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.23|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.23
74059917|NCT04035694|147672849|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.05|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.05
73881947|NCT04864249|147297752|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
74059918|NCT04035694|147672850|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.95|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.95
74059919|NCT04035694|147672851|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.99|STANDARD_ERROR_OF_MEAN|0.72||0.19|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.19
74059920|NCT04035694|147672852|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.59||0.92|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.92
74059921|NCT04035694|147672853|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.13||0.81|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.81
74059922|NCT04035694|147672854|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.81|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.81
74059923|NCT04035694|147672855|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.1||0.14|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.14
74059924|NCT04035694|147672856|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.82|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.82
74059925|NCT04035694|147672857|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.97|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.97
74059926|NCT04035694|147672858|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.89|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.89
74101983|NCT02942004|147754079|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0493|TWO_SIDED|95.0|1.0|6.9|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.9|1.0|0.0493
74101984|NCT02942004|147754079|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0572|TWO_SIDED|95.0|1.0|6.5|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.5|1.0|0.0572
74101985|NCT02942004|147754079|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6768|TWO_SIDED|95.0|0.5|3.0|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||3.0|0.5|0.6768
74101986|NCT02942004|147754079|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0035|TWO_SIDED|95.0|1.7|16.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||16.8|1.7|0.0035
74101987|NCT02942004|147754079|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0347|TWO_SIDED|95.0|1.1|7.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||7.8|1.1|0.0347
74101988|NCT02942004|147754080|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0011|TWO_SIDED|95.0|2.1|17.8|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||17.8|2.1|0.0011
74101989|NCT02942004|147754080|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0828|TWO_SIDED|95.0|0.9|7.6|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||7.6|0.9|0.0828
74101990|NCT02942004|147754080|SUPERIORITY||Odds Ratio (OR)|1.2||||0.7749|TWO_SIDED|95.0|0.4|3.1|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||3.1|0.4|0.7749
74101991|NCT02942004|147754080|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3401|TWO_SIDED|95.0|0.2|1.7|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||1.7|0.2|0.3401
74101992|NCT02942004|147754080|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1052|TWO_SIDED|95.0|0.8|6.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.0|0.8|0.1052
74101993|NCT02942004|147754080|SUPERIORITY||Odds Ratio (OR)|1.6||||0.3507|TWO_SIDED|95.0|0.6|4.2|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||4.2|0.6|0.3507
74101994|NCT02942004|147754081|SUPERIORITY||LS mean difference|-12.07|STANDARD_ERROR_OF_MEAN|4.294||0.0058|TWO_SIDED|95.0|-20.58|-3.56|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-3.56|-20.58|0.0058
74101995|NCT02942004|147754081|SUPERIORITY||LS mean difference|-5.89|STANDARD_ERROR_OF_MEAN|4.188||0.1622|TWO_SIDED|95.0|-14.19|2.41|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||2.41|-14.19|0.1622
74101996|NCT02942004|147754081|SUPERIORITY||LS mean difference|-9.09|STANDARD_ERROR_OF_MEAN|4.51||0.0462|TWO_SIDED|95.0|-18.02|-0.16|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-0.16|-18.02|0.0462
74101997|NCT02942004|147754081|SUPERIORITY||LS mean difference|-2.24|STANDARD_ERROR_OF_MEAN|4.41||0.6124|TWO_SIDED|95.0|-10.97|6.49|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||6.49|-10.97|0.6124
74101998|NCT02942004|147754081|SUPERIORITY||LS mean difference|-11.68|STANDARD_ERROR_OF_MEAN|4.556||0.0116|TWO_SIDED|95.0|-20.71|-2.66|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-2.66|-20.71|0.0116
74101999|NCT02942004|147754081|SUPERIORITY||LS mean difference|-8.26|STANDARD_ERROR_OF_MEAN|4.464||0.0667|TWO_SIDED|95.0|-17.1|0.58|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||0.58|-17.10|0.0667
74102000|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.191||0.9681|TWO_SIDED|95.0|-0.39|0.37|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.39|0.9681
74102001|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.185||0.6337|TWO_SIDED|95.0|-0.28|0.46|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.28|0.6337
74102002|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.238||0.469|TWO_SIDED|95.0|-0.64|0.3|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.64|0.4690
74102003|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.232||0.9905|TWO_SIDED|95.0|-0.46|0.46|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.46|0.9905
74102004|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.3984|TWO_SIDED|95.0|-0.68|0.27|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.68|0.3984
74102005|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.234||0.7042|TWO_SIDED|95.0|-0.37|0.55|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-0.37|0.7042
74102006|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.247||0.4941|TWO_SIDED|95.0|-0.66|0.32|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.66|0.4941
74102007|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.24||0.4572|TWO_SIDED|95.0|-0.3|0.65|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.65|-0.30|0.4572
74102008|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.236||0.9866|TWO_SIDED|95.0|-0.47|0.46|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.47|0.9866
74102009|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.229||0.749|TWO_SIDED|95.0|-0.53|0.38|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|-0.53|0.7490
74059927|NCT04035694|147672859|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.69
74059928|NCT04035694|147672860|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.63|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.63
74059929|NCT04035694|147672861|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.79|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.79
74059930|NCT04035694|147672862|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.93|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.93
74059931|NCT04035694|147672863|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|2.98|STANDARD_ERROR_OF_MEAN|2.18||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.20
74059932|NCT04035694|147672864|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|2.52||0.11|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.11
74102010|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.247||0.0235|TWO_SIDED|95.0|-1.06|-0.08|||MMRM|||Depressed Mood, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-1.06|0.0235
74102011|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.239||0.9286|TWO_SIDED|95.0|-0.5|0.45|||MMRM|||Depressed Mood, Change Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.50|0.9286
74102012|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.251||0.0544|TWO_SIDED|95.0|-0.99|0.01|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.99|0.0544
74102013|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.244||0.2903|TWO_SIDED|95.0|-0.74|0.22|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.74|0.2903
74102014|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.244||0.0044|TWO_SIDED|95.0|-1.19|-0.23|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-1.19|0.0044
74102015|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.238||0.1339|TWO_SIDED|95.0|-0.83|0.11|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.83|0.1339
74102016|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.234||0.0149|TWO_SIDED|95.0|-1.04|-0.11|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-1.04|0.0149
74102017|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3213|TWO_SIDED|95.0|-0.68|0.22|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.68|0.3213
74102018|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.246||0.0703|TWO_SIDED|95.0|-0.94|0.04|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.94|0.0703
74102019|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.8152|TWO_SIDED|95.0|-0.53|0.42|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.53|0.8152
74102020|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.301||0.0805|TWO_SIDED|95.0|-1.13|0.07|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-1.13|0.0805
74102021|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.291||0.6964|TWO_SIDED|95.0|-0.69|0.46|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.69|0.6964
74102022|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.304||0.2998|TWO_SIDED|95.0|-0.92|0.29|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.92|0.2998
74102023|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.291||0.3448|TWO_SIDED|95.0|-0.85|0.3|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.85|0.3448
74102024|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.248||0.0089|TWO_SIDED|95.0|-1.15|-0.17|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-1.15|0.0089
74102025|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.244||0.0772|TWO_SIDED|95.0|-0.92|0.05|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.92|0.0772
74102026|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.191||0.6809|TWO_SIDED|95.0|-0.46|0.3|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.46|0.6809
73881948|NCT00300755|147297753|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||<0.001
74102027|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.185||0.7297|TWO_SIDED|95.0|-0.3|0.43|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.30|0.7297
74102028|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.226||0.0626|TWO_SIDED|95.0|-0.87|0.02|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.87|0.0626
74102029|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5196|TWO_SIDED|95.0|-0.58|0.29|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.58|0.5196
74102030|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.234||0.0772|TWO_SIDED|95.0|-0.88|0.05|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.88|0.0772
74102031|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.228||0.661|TWO_SIDED|95.0|-0.55|0.35|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.55|0.6610
74102032|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.239||0.4007|TWO_SIDED|95.0|-0.67|0.27|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.67|0.4007
74102033|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.232||0.2292|TWO_SIDED|95.0|-0.18|0.74|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.74|-0.18|0.2292
74102034|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.234||0.054|TWO_SIDED|95.0|-0.92|0.01|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.92|0.0540
74102035|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.227||0.959|TWO_SIDED|95.0|-0.44|0.46|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.44|0.9590
74102036|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.218||0.1048|TWO_SIDED|95.0|-0.79|0.08|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.79|0.1048
74102037|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8979|TWO_SIDED|95.0|-0.44|0.39|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.44|0.8979
74102038|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.219||0.0819|TWO_SIDED|95.0|-0.82|0.05|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.82|0.0819
74102039|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.213||0.1099|TWO_SIDED|95.0|-0.77|0.08|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.77|0.1099
74102040|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.215||0.0373|TWO_SIDED|95.0|-0.88|-0.03|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.88|0.0373
74102041|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.209||0.0577|TWO_SIDED|95.0|-0.81|0.01|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.81|0.0577
74102042|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2023|TWO_SIDED|95.0|-0.69|0.15|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.69|0.2023
74102043|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.204||0.4444|TWO_SIDED|95.0|-0.56|0.25|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.56|0.4444
74102044|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.3645|TWO_SIDED|95.0|-0.64|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.64|0.3645
74059933|NCT04035694|147672865|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-6.93|STANDARD_ERROR_OF_MEAN|2.38||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
74059934|NCT04035694|147672866|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-2.24|STANDARD_ERROR_OF_MEAN|4.45||0.64|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.64
74059935|NCT04035694|147672867|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-6.46|STANDARD_ERROR_OF_MEAN|2.53||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
73881949|NCT00300755|147297753|SUPERIORITY_OR_OTHER|||||||0.063|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||0.063
73881950|NCT00300755|147297753|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||< 0.001
74059936|NCT04035694|147672868|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|1.23|STANDARD_ERROR_OF_MEAN|2.68||0.65|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.65
74102045|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.214||0.4035|TWO_SIDED|95.0|-0.6|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.60|0.4035
74102046|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.232||0.4877|TWO_SIDED|95.0|-0.62|0.3|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.62|0.4877
74102047|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.226||0.3134|TWO_SIDED|95.0|-0.68|0.22|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.68|0.3134
74102048|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.24||0.0922|TWO_SIDED|95.0|-0.89|0.07|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.89|0.0922
74102049|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.23||0.0761|TWO_SIDED|95.0|-0.87|0.04|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.87|0.0761
74102050|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.217||0.3275|TWO_SIDED|95.0|-0.64|0.22|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.64|0.3275
74102051|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.213||0.3041|TWO_SIDED|95.0|-0.64|0.2|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.64|0.3041
74102052|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.146||0.045|TWO_SIDED|95.0|-0.59|-0.01|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.59|0.0450
74102053|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.143||0.5351|TWO_SIDED|95.0|-0.19|0.37|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.19|0.5351
74059937|NCT04035694|147672869|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||<.01
74059938|NCT04035694|147672870|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.22||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.20
74059939|NCT04035694|147672871|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.22||0.28|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.28
74059940|NCT04035694|147672872|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|1.56|STANDARD_ERROR_OF_MEAN|2.77||0.58|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.58
74059941|NCT04035694|147672873|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.49|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.49
74059942|NCT04035694|147672874|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.14||0.55|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.55
74059943|NCT04035694|147672875|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.54|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.54
74059944|NCT04035694|147672876|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.1||0.95|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.95
74059945|NCT04035694|147672877|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-4.25|STANDARD_ERROR_OF_MEAN|2.15||0.05|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.05
74059946|NCT04035694|147672878|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|1.37|STANDARD_ERROR_OF_MEAN|3.84||0.75|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.75
73881951|NCT00300755|147297753|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.004
74059947|NCT04035694|147672879|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.14|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.14
74059948|NCT04035694|147672880|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
74059949|NCT04035694|147672881|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.06||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
74059950|NCT04035694|147672882|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.02
74059951|NCT04035694|147672883|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
74059952|NCT04035694|147672884|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.57|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.57
74059953|NCT04035694|147672885|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.91|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.91
74059954|NCT04035694|147672886|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.72|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.72
74059955|NCT04035694|147672887|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.07
74059956|NCT04035694|147672888|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.1||0.56|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.56
74059957|NCT04035694|147672889|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.17
74059958|NCT04035694|147672890|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.89|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.89
74059959|NCT04035694|147672891|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.08||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.20
74059960|NCT04035694|147672892|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.78|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.78
74059961|NCT04035694|147672893|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.41
74059962|NCT04035694|147672894|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.34
74059963|NCT00442338|147672895|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.01||||0.871|TWO_SIDED|95.0|-0.07|0.08|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the least square (LS) means of time weighted average change FEV1 (0-60 min) using an Analysis of Covariance (ANCOVA) model.||0.08|-0.07|0.871
74059964|NCT00442338|147672895|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.794|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.||0.06|-0.08|0.794
74059965|NCT00442338|147672895|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.675|TWO_SIDED|95.0|-0.06|0.09|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.||0.09|-0.06|0.675
74059966|NCT01125358|147672896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.02|||||TWO_SIDED|90.0|-3.37|0.0|||Multiple Comparisons with The Best (MCB)|LS mean difference = LS mean of 10 mg LY2140023 - LS mean of 80 mg LY2140023.||||0.00|-3.37|
74059967|NCT01125358|147672896|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.05|||||TWO_SIDED|90.0|-2.42|0.32|||Multiple Comparison with The Best (MCB)|LS mean difference = LS mean of 160 mg LY2140023 - LS mean of 80 mg LY2140023.||||0.32|-2.42|
74059968|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-9.84|STANDARD_ERROR_OF_MEAN|7.96||0.222|TWO_SIDED|95.0|-25.8|6.12||P-value is for PANSS Total Score.|MMRM|||||6.12|-25.80|0.222
74059969|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-11.91|STANDARD_ERROR_OF_MEAN|7.22||0.105|TWO_SIDED|95.0|-26.42|2.6||P-value is for PANSS Total Score.|MMRM|||||2.60|-26.42|0.105
74059970|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-7.96|STANDARD_ERROR_OF_MEAN|7.73||0.308|TWO_SIDED|95.0|-23.46|7.55||P-value is for PANSS Total Score.|MMRM|||||7.55|-23.46|0.308
74059971|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.6|STANDARD_ERROR_OF_MEAN|2.06||0.441|TWO_SIDED|95.0|-5.74|2.54||P-value is for PANSS Positive Subscore.|MMRM|||||2.54|-5.74|0.441
74059972|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-4.22|STANDARD_ERROR_OF_MEAN|1.88||0.03||95.0|-8.01|-0.44||P-value is for PANSS Positive Subscore.|MMRM|||||-0.44|-8.01|0.030
74059973|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.98|STANDARD_ERROR_OF_MEAN|1.98||0.323|TWO_SIDED|95.0|-5.96|2.01||P-value is for PANSS Positive Subscore.|MMRM|||||2.01|-5.96|0.323
74059974|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.46|STANDARD_ERROR_OF_MEAN|2.28||0.285|TWO_SIDED|95.0|-7.05|2.12||P-value is for PANSS Negative Subscore.|MMRM|||||2.12|-7.05|0.285
74059975|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.92|STANDARD_ERROR_OF_MEAN|2.07||0.166|TWO_SIDED|95.0|-7.1|1.26||P-value is for PANSS Negative Subscore.|MMRM|||||1.26|-7.10|0.166
74059976|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.37|STANDARD_ERROR_OF_MEAN|2.2||0.286|TWO_SIDED|95.0|-6.79|2.05||P-value is for PANSS Negative Subscore.|MMRM|||||2.05|-6.79|0.286
74059977|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.67|STANDARD_ERROR_OF_MEAN|4.14||0.177|TWO_SIDED|95.0|-13.96|2.63||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||2.63|-13.96|0.177
74059978|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.1|STANDARD_ERROR_OF_MEAN|3.74||0.178|TWO_SIDED|95.0|-12.6|2.4||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||2.40|-12.60|0.178
74059979|NCT01125358|147672897|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-3.61|STANDARD_ERROR_OF_MEAN|4.05||0.377|TWO_SIDED|95.0|-11.72|4.51||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||4.51|-11.72|0.377
74102054|NCT02942004|147754082|SUPERIORITY||LS men difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0525|TWO_SIDED|95.0|-0.56|0.0|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.56|0.0525
74102055|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.139||0.7932|TWO_SIDED|95.0|-0.24|0.31|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.24|0.7932
74102056|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.128||0.13|TWO_SIDED|95.0|-0.45|0.06|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.45|0.1300
73881952|NCT00300755|147297753|SUPERIORITY_OR_OTHER|||||||0.082|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.082
74059980|NCT01125358|147672898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.87|STANDARD_ERROR_OF_MEAN|0.48||0.077|TWO_SIDED|95.0|-0.1|1.83|||MMRM|||||1.83|-0.10|0.077
74102057|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.125||0.1631|TWO_SIDED|95.0|-0.07|0.42|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.07|0.1631
74102058|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.129||0.8215|TWO_SIDED|95.0|-0.23|0.29|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.23|0.8215
74102059|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.126||0.038|TWO_SIDED|95.0|0.01|0.51|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.51|0.01|0.0380
73881953|NCT00300755|147297753|SUPERIORITY_OR_OTHER|||||||0.217|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.217
73881954|NCT00300755|147297754|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.||||0.002
74059981|NCT01125358|147672898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.24|STANDARD_ERROR_OF_MEAN|0.44||0.592|TWO_SIDED|95.0|-1.12|0.65|||MMRM|||||0.65|-1.12|0.592
74059982|NCT01125358|147672898|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.39|STANDARD_ERROR_OF_MEAN|0.46||0.395|TWO_SIDED|95.0|-0.53|1.32|||MMRM|||||1.32|-0.53|0.395
74059983|NCT01125358|147672899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|4.64|STANDARD_ERROR_OF_MEAN|4.49||0.306|TWO_SIDED|95.0|-4.37|13.65|||MMRM|||||13.65|-4.37|0.306
74059984|NCT01125358|147672899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.82|STANDARD_ERROR_OF_MEAN|4.26||0.849|TWO_SIDED|95.0|-7.74|9.38|||MMRM|||||9.38|-7.74|0.849
74059985|NCT01125358|147672899|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.09|STANDARD_ERROR_OF_MEAN|4.46||0.259||95.0|-14.05|3.86|||MMRM|||||3.86|-14.05|0.259
74059986|NCT01125358|147672901|SUPERIORITY_OR_OTHER_LEGACY|||||||0.354||95.0|||||Fisher Exact|||||||0.354
74102060|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.124||0.507|TWO_SIDED|95.0|-0.33|0.16|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.33|0.5070
74102061|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1094|TWO_SIDED|95.0|-0.04|0.43|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.04|0.1094
74059987|NCT01125358|147672901|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181||95.0|||||Fisher Exact|||||||0.181
74059988|NCT01125358|147672901|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
74059989|NCT00116207|147672958|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE||||0.32
74059990|NCT00116207|147672958|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24-MONTH||||0.045
74059991|NCT00116207|147672959|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE||||0.52
74059992|NCT00116207|147672959|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.82
74059993|NCT00116207|147672960|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||p values were computed using a general linear model adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.24
74059994|NCT00116207|147672961|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.83
74059995|NCT00728988|147672962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.9237|TWO_SIDED|95.0|-7.3|9.3|||Chi-squared, Corrected||95% confidence interval for the true difference in the incidence of MACE between the two treatment groups. Difference of incidence = usual care minus atorvastatin.|Total MACE: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||9.3|-7.3|0.9237
74059996|NCT00728988|147672962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-10.7|10.7|||Fisher Exact||Confidence limits were calculated by the exact unconditional inference. Difference of incidence = usual care minus atorvastatin.|Death: treatment difference. Null hypothesis = no difference between the incidence rates in two groups. Fisher's exact test was applied because the expected frequency of events was less than 5.||10.7|-10.7|1.0000
74059997|NCT00728988|147672962|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.9158|TWO_SIDED|95.0|-7.2|9.2|||Chi-squared, Corrected||Difference of incidence = usual care minus atorvastatin.|Myocardial Infarction: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||9.2|-7.2|0.9158
74059998|NCT00728988|147672962|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93||||0.8|TWO_SIDED|95.0|0.5104|1.6846|||Regression, Logistic|||Unadjusted odds ratio and 95% confidence interval calculated by including treatment group as the only covariate in the logistic regression model. Reference group = usual care.||1.6846|0.5104|0.80
73881955|NCT00300755|147297754|SUPERIORITY_OR_OTHER|||||||0.033|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.||||0.033
74059999|NCT00728988|147672962|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.9|TWO_SIDED|95.0|0.4887|1.8836|||Regression, Logistic|||Adjusted odds ratio: model includes treatment group and potential confounding covariates age, gender, country, non-ST elevation myocardial infarction, LVEF \<=40, and use of beta-blockers, ACE-inhibitors, angiotension receptor blockers, calcium channel antagonists, and diuretics. Reference group = usual care.||1.8836|0.4887|0.90
74060000|NCT00728988|147672962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8494|TWO_SIDED||||||Log Rank|Survival analysis: Kaplan-Meier log rank test.||MACE-free survival up to Day 30. A censoring variable with a value of 1 denoted that the subject had the event and 0 indicated that the subject was censored. A log-rank test was applied to investigate any differences on the survival distribution function between two treatment groups.||||0.8494
74060001|NCT00728988|147672963|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||1|TWO_SIDED|95.0|-5.6|6.3|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care.|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||6.3|-5.6|1.0000
74060002|NCT00728988|147672964|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.7896|TWO_SIDED|95.0|-9.7|6.5|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care .|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||6.5|-9.7|0.7896
74060003|NCT00728988|147672965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4||||0.631|TWO_SIDED|95.0|-10.1|5.4|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||5.4|-10.1|0.631
74060004|NCT00728988|147672965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.518|TWO_SIDED|95.0|-12.1|5.5|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||5.5|-12.1|0.518
74060005|NCT00728988|147672965|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.236|TWO_SIDED|95.0|-9.6|12.0|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||12.0|-9.6|0.236
74060006|NCT00728988|147672966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.9||||0.425|TWO_SIDED|95.0|-6.2|15.9|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||15.9|-6.2|0.425
74060007|NCT00728988|147672966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3||||0.392|TWO_SIDED|95.0|-6.1|16.7|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||16.7|-6.1|0.392
74060008|NCT00728988|147672966|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||1|TWO_SIDED|95.0|-10.7|10.9|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||10.9|-10.7|1.000
74060009|NCT00728988|147672967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7||||0.529|TWO_SIDED|95.0|-9.6|4.3|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||4.3|-9.6|0.529
74060010|NCT00728988|147672967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.827|TWO_SIDED|95.0|-5.8|3.6|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||3.6|-5.8|0.827
74060011|NCT00728988|147672967|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.616|TWO_SIDED|95.0|-10.3|11.5|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||11.5|-10.3|0.616
74102062|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.099||0.3112|TWO_SIDED|95.0|-0.3|0.1|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.30|0.3112
74102063|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.096||0.1345|TWO_SIDED|95.0|-0.05|0.33|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.05|0.1345
74060012|NCT00728988|147672968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.53||||0.7554|TWO_SIDED|95.0|-215.87|156.81|||ANOVA|||8 hours post-PCI: difference (% change).||156.81|-215.87|0.7554
74060013|NCT00728988|147672968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|50.58||||0.7436|TWO_SIDED|95.0|-253.42|354.58|||ANOVA|||24 hours post-PCI: difference (% change).||354.58|-253.42|0.7436
74060014|NCT00728988|147672968|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-58.22||||0.4741|TWO_SIDED|95.0|-218.12|101.68|||ANOVA|||30 days post-PCI: difference (% change).||101.68|-218.12|0.4741
74102064|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.091||0.5148|TWO_SIDED|95.0|-0.24|0.12|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.24|0.5148
74060015|NCT03000075|147672977|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant psoriatic arthritis (PsA) at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|73.6|||<|0.001|TWO_SIDED|95.0|62.2|85.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% confidence interval (CI) for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||85.0|62.2|< 0.001
74060016|NCT03000075|147672977|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|72.4|||<|0.001|TWO_SIDED|95.0|60.6|84.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||84.1|60.6|< 0.001
74060017|NCT03000075|147672979|OTHER||Adjusted percentage difference|75.0|||<|0.001|TWO_SIDED|95.0|63.8|86.2||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||86.2|63.8|< 0.001
74060018|NCT03000075|147672979|OTHER||Adjusted percentage difference|82.4|||<|0.001|TWO_SIDED|95.0|72.2|92.6||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||92.6|72.2|< 0.001
74060019|NCT03000075|147672981|OTHER||Adjusted percentage difference|80.3|||<|0.001|TWO_SIDED|95.0|70.1|90.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||90.4|70.1|< 0.001
74060020|NCT03000075|147672981|OTHER||Adjusted percentage difference|86.0|||<|0.001|TWO_SIDED|95.0|76.8|95.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||95.1|76.8|< 0.001
74060021|NCT03000075|147672983|OTHER||Adjusted percentage difference|22.6|||<|0.001|TWO_SIDED|95.0|11.8|33.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||33.4|11.8|< 0.001
74060022|NCT03000075|147672983|OTHER||Adjusted percentage difference|32.5|||<|0.001|TWO_SIDED|95.0|20.0|45.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||45.0|20.0|< 0.001
74060023|NCT03000075|147672985|OTHER||Adjusted percentage difference|39.2||||0.131|TWO_SIDED|95.0|-11.6|90.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||90.1|-11.6|0.131
74060024|NCT03000075|147672985|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|31.3||||0.269|TWO_SIDED|95.0|-24.2|86.7||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||86.7|-24.2|0.269
74060025|NCT00111007|147672987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.906||||0.492|TWO_SIDED|95.0|0.627|1.31|||log rank test|||||1.310|0.627|0.492
74060026|NCT00111007|147672988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.979|TWO_SIDED|95.0|0.744|1.333|||log rank test|||||1.333|0.744|0.979
74060027|NCT00111007|147672989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.331|TWO_SIDED|95.0|0.641|1.162|||log rank test|||||1.162|0.641|0.331
74060028|NCT00111007|147672990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.398||||0.146|TWO_SIDED|95.0|0.11|1.437|||log rank test|||||1.437|0.110|0.146
74060029|NCT00111007|147672991|SUPERIORITY_OR_OTHER|||||||0.389||95.0|||||Fisher Exact|||||||0.389
74102065|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.088||0.3863|TWO_SIDED|95.0|-0.25|0.1|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.25|0.3863
74060030|NCT00440193|147672993|NON_INFERIORITY_OR_EQUIVALENCE|Assuming equal efficacy, a total of 88 events was calculated to give a power of 90% to prove that rivaroxaban is at least as effective as the comparator, considering a non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided α=0.05). A mean incidence for the primary efficacy outcome of 3% was expected and at least 1465 participants per group were determined to be necessary. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|0.68|STANDARD_ERROR_OF_MEAN|0.2179|<|0.0001||95.0|0.44|1.04|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.||1.04|0.44|< 0.0001
74060031|NCT00440193|147672994|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.1616||0.044||95.0|0.53|0.99||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||0.99|0.53|0.044
74060032|NCT00440193|147672995|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|STANDARD_ERROR_OF_MEAN|0.1828||0.027||95.0|0.47|0.95||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||0.95|0.47|0.027
74060033|NCT00440193|147672997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97|STANDARD_ERROR_OF_MEAN|0.1204||0.77||95.0|0.76|1.22||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.22|0.76|0.77
74060034|NCT02864953|147673009|SUPERIORITY||Odds Ratio (OR)|1.17|||=|0.415|TWO_SIDED|95.0|0.8|1.71||P-value was analyzed by ordinal logistic regression adjusting for covariates: region, and IRT stratification factors including rtPA usage (yes/no), thrombectomy usage (yes/no), use of ASPECTS for screening (yes/no), baseline NIHSS (\<=20 vs. \>20).|Regression, Logistic|||||1.71|0.80|=0.4150
74060035|NCT02864953|147673011|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.7413|TWO_SIDED|95.0|0.72|1.6||A logistic regression model was used to estimate an odds ratio (and 95% CI) of improvement on the mRS dichotomized as 0-4 vs. 5-6 at Day 90.|Regression, Logistic|||||1.60|0.72|=0.7413
74060036|NCT02864953|147673012|SUPERIORITY||Mean Difference (Final Values)|0.82|||=|0.1242|TWO_SIDED|95.0|-0.23|1.87||Analysis of Variance (ANOVA) was used to compare the two study arms to assess the treatment effects on midline shift.|ANOVA|||||1.87|-0.23|=0.1242
74060037|NCT03205163|147673049|OTHER||GMR|1.35||||0.032|TWO_SIDED|95.0|1.04|1.77|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an analysis of variance (ANOVA) model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and geometric mean ratio (GMR) were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.77|1.04|0.032
74060038|NCT03205163|147673050|OTHER||GMR|1.17|||<|0.001|TWO_SIDED|95.0|1.09|1.25|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.25|1.09|<0.001
74060039|NCT03205163|147673051|OTHER||GMR|4.13|||<|0.001|TWO_SIDED|95.0|2.94|5.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.79|2.94|<0.001
74060040|NCT03205163|147673052|OTHER||GMR|3.24|||<|0.001|TWO_SIDED|95.0|2.76|3.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||3.79|2.76|<0.001
74060041|NCT03205163|147673053|OTHER||GMR|0.143|||<|0.001|TWO_SIDED|95.0|0.118|0.172|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.172|0.118|<0.001
74060042|NCT03205163|147673054|OTHER||GMR|0.153|||<|0.001|TWO_SIDED|95.0|0.138|0.17|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.170|0.138|<0.001
74060043|NCT03205163|147673055|OTHER||GMR|0.622||||0.003|TWO_SIDED|95.0|0.492|0.786|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.786|0.492|0.003
74060044|NCT03205163|147673056|OTHER||GMR|0.599|||<|0.001|TWO_SIDED|95.0|0.525|0.684|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.684|0.525|<0.001
74060045|NCT03205163|147673057|OTHER||GMR|7.0|||<|0.001|TWO_SIDED|95.0|5.78|8.48|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||8.48|5.78|<0.001
73881956|NCT00300755|147297754|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.||||<0.001
74060046|NCT03205163|147673058|OTHER||GMR|6.54|||<|0.001|TWO_SIDED|95.0|5.89|7.27|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||7.27|5.89|<0.001
74060047|NCT03205163|147673059|OTHER||GMR|4.54|||<|0.001|TWO_SIDED|95.0|3.64|5.66|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.66|3.64|<0.001
74060048|NCT03205163|147673060|OTHER||GMR|4.32|||<|0.001|TWO_SIDED|95.0|3.96|4.72|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||4.72|3.96|<0.001
74060049|NCT03205163|147673061|OTHER||GMR|1.36||||0.063|TWO_SIDED|95.0|0.978|1.89|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.89|0.978|0.063
74060050|NCT03205163|147673062|OTHER||GMR|1.18|||<|0.001|TWO_SIDED|95.0|1.1|1.26|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.26|1.10|<0.001
74060051|NCT03205163|147673063|OTHER||GMR|4.57|||<|0.001|TWO_SIDED|95.0|4.0|5.23|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.23|4.00|<0.001
74060052|NCT03205163|147673064|OTHER||GMR|4.46|||<|0.001|TWO_SIDED|95.0|4.16|4.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||4.79|4.16|<0.001
74060053|NCT02545868|147673066|SUPERIORITY||normal distribution approximation|-30.7|||||TWO_SIDED|95.0|-50.5|-10.8||||||Difference in positive response, Group A minus Group B||-10.8|-50.5|
74060054|NCT02545868|147673067|SUPERIORITY||normal distribution approximation|-36.4|||||TWO_SIDED|95.0|-56.0|-16.7||||||Difference in positive response, Group A minus Group B||-16.7|-56.0|
74060055|NCT02545868|147673068|SUPERIORITY||normal distribution approximation|-47.0|||||TWO_SIDED|95.0|-63.2|-30.7||||||Difference in positive response, Group A minus Group B||-30.7|-63.2|
74060056|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-50.7|||||TWO_SIDED|95.0|-62.7|-38.8||||||Serotype 1||-38.8|-62.7|
74060057|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-43.3|||||TWO_SIDED|95.0|-56.5|-30.1||||||Serotype 2||-30.1|-56.5|
74060058|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-48.0|||||TWO_SIDED|95.0|-65.2|-30.9||||||Serotype 3||-30.9|-65.2|
74060059|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-62.8|||||TWO_SIDED|95.0|-77.2|-48.4||||||Serotype 4||-48.4|-77.2|
74060060|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-53.8|||||TWO_SIDED|95.0|-68.0|-39.7||||||Serotype 5||-39.7|-68.0|
74060061|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-37.5|||||TWO_SIDED|95.0|-54.4|-20.7||||||Serotype 6B||-20.7|-54.4|
74060062|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-58.3|||||TWO_SIDED|95.0|-73.1|-43.6||||||Serotype 7F||-43.6|-73.1|
74060063|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-32.9|||||TWO_SIDED|95.0|-45.7|-20.1||||||Serotype 8||-20.1|-45.7|
74060064|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-46.4|||||TWO_SIDED|95.0|-62.5|-30.4||||||Serotype 9N||-30.4|-62.5|
74060065|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-40.4|||||TWO_SIDED|95.0|-55.7|-25.1||||||Serotype 9V||-25.1|-55.7|
74060066|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-62.8|||||TWO_SIDED|95.0|-77.2|-48.4||||||Serotype 10A||-48.4|-77.2|
74060067|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-69.4|-35.6||||||Serotype 11A||-35.6|-69.4|
74060068|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-55.6|||||TWO_SIDED|95.0|-72.8|-38.3||||||Serotype 12F||-38.3|-72.8|
74060069|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-25.5|||||TWO_SIDED|95.0|-41.4|-9.7||||||Serotype 14||-9.7|-41.4|
74060070|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-47.9|||||TWO_SIDED|95.0|-63.9|-32.0||||||Serotype 15B||-32.0|-63.9|
74060071|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-56.9|||||TWO_SIDED|95.0|-72.4|-41.4||||||Serotype 17F||-41.4|-72.4|
74060072|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-52.4|||||TWO_SIDED|95.0|-67.4|-37.3||||||Serotype 18C||-37.3|-67.4|
74060073|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-46.4|||||TWO_SIDED|95.0|-62.5|-30.4||||||Serotype 19A||-30.4|-62.5|
74060074|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-68.8|-36.1||||||Serotype 19F||-36.1|-68.8|
74060075|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-61.5|||||TWO_SIDED|95.0|-77.5|-45.4||||||Serotype 20||-45.4|-77.5|
74060076|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-56.8|||||TWO_SIDED|95.0|-71.7|-42.0||||||Serotype 22F||-42.0|-71.7|
74060077|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-33.2|||||TWO_SIDED|95.0|-51.7|-14.6||||||Serotype 23F||-14.6|-51.7|
74060078|NCT02545868|147673072|SUPERIORITY||Normal Distribution Approximation|-47.8|||||TWO_SIDED|95.0|-62.2|-33.5||||||Serotype 33F||-33.5|-62.2|
74060079|NCT02545868|147673073|SUPERIORITY||Normal Distribution Approximation|-13.4|||||TWO_SIDED|95.0|-21.6|-5.3||||||||-5.3|-21.6|
74060080|NCT02545868|147673074|SUPERIORITY||Normal Distribution Approximation|-59.7|||||TWO_SIDED|95.0|-72.6|-46.8||||||||-46.8|-72.6|
74102066|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.094||0.0209|TWO_SIDED|95.0|-0.41|-0.03|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.41|0.0209
74102067|NCT02942004|147754082|SUPERIORITY||LS men difference|-0.17|STANDARD_ERROR_OF_MEAN|0.092||0.0616|TWO_SIDED|95.0|-0.35|0.01|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.35|0.0616
74102068|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.099||0.186|TWO_SIDED|95.0|-0.33|0.06|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.33|0.1860
74060081|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-45.2|||||TWO_SIDED|95.0|-62.7|-27.6||||||Serotype 1- Difference in positive response, Group A1 minus Group B||-27.6|-62.7|
74060082|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-42.2|||||TWO_SIDED|95.0|-60.6|-23.8||||||Serotype 2- Difference in positive response, Group A1 minus Group B||-23.8|-60.6|
74060083|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-49.8|||||TWO_SIDED|95.0|-70.4|-29.2||||||Serotype 3- Difference in positive response, Group A1 minus Group B||-29.2|-70.4|
74060084|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-56.0|||||TWO_SIDED|95.0|-75.7|-36.3||||||Serotype 4- Difference in positive response, Group A1 minus Group B||-36.3|-75.7|
74060085|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-58.3|||||TWO_SIDED|95.0|-76.4|-40.3||||||Serotype 5- Difference in positive response, Group A1 minus Group B||-40.3|-76.4|
74060086|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-34.0|||||TWO_SIDED|95.0|-55.7|-12.2||||||Serotype 6B- Difference in positive response, Group A1 minus Group B||-12.2|-55.7|
74060087|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-42.5|||||TWO_SIDED|95.0|-61.8|-23.2||||||Serotype 7F- Difference in positive response, Group A1 minus Group B||-23.2|-61.8|
74060088|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-42.2|||||TWO_SIDED|95.0|-60.6|-23.8||||||Serotype 8- Difference in positive response, Group A1 minus Group B||-23.8|-60.6|
74060089|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-37.2|||||TWO_SIDED|95.0|-58.9|-15.5||||||Serotype 9N- Difference in positive response, Group A1 minus Group B||-15.5|-58.9|
74060090|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-36.6|||||TWO_SIDED|95.0|-57.3|-16.0||||||Serotype 9V- Difference in positive response, Group A1 minus Group B||-16.0|-57.3|
74102069|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.095||0.773|TWO_SIDED|95.0|-0.22|0.16|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.22|0.7730
74060091|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-62.1|||||TWO_SIDED|95.0|-80.8|-43.5||||||Serotype 10A- Difference in positive response, Group A1 minus Group B||-43.5|-80.8|
74060092|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-50.1|||||TWO_SIDED|95.0|-71.0|-29.2||||||Serotype 11A- Difference in positive response, Group A1 minus Group B||-29.2|-71.0|
74060093|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-56.8|||||TWO_SIDED|95.0|-76.9|-36.8||||||Serotype 12F- Difference in positive response, Group A1 minus Group B||-36.8|-76.9|
74060094|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-20.8|||||TWO_SIDED|95.0|-41.4|-0.2||||||Serotype 14- Difference in positive response, Group A1 minus Group B||-0.2|-41.4|
74060095|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-52.8|||||TWO_SIDED|95.0|-72.8|-32.7||||||Serotype 15B- Difference in positive response, Group A1 minus Group B||-32.7|-72.8|
74060096|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-46.3|||||TWO_SIDED|95.0|-66.8|-25.8||||||Serotype 17F- Difference in positive response, Group A1 minus Group B||-25.8|-66.8|
74060097|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-42.5|||||TWO_SIDED|95.0|-61.8|-23.2||||||Serotype 18C- Difference in positive response, Group A1 minus Group B||-23.2|-61.8|
74060098|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-30.2|||||TWO_SIDED|95.0|-50.6|-9.7||||||Serotype 19A- Difference in positive response, Group A1 minus Group B||-9.7|-50.6|
74060099|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-46.3|||||TWO_SIDED|95.0|-66.8|-25.8||||||Serotype 19F- Difference in positive response, Group A1 minus Group B||-25.8|-66.8|
74060100|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-59.5|||||TWO_SIDED|95.0|-79.0|-40.0||||||Serotype 20- Difference in positive response, Group A1 minus Group B||-40.0|-79.0|
74060101|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-72.1|-32.8||||||Serotype 22F- Difference in positive response, Group A1 minus Group B||-32.8|-72.1|
74060102|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-28.1|||||TWO_SIDED|95.0|-50.7|-5.4||||||Serotype 23F- Difference in positive response, Group A1 minus Group B||-5.4|-50.7|
74060103|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-49.0|||||TWO_SIDED|95.0|-68.2|-29.7||||||Serotype 33F- Difference in positive response, Group A1 minus Group B||-29.7|-68.2|
73881957|NCT00300755|147297754|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.||||0.002
73881958|NCT00300755|147297754|SUPERIORITY_OR_OTHER|||||||0.009|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Refusal to eat.||||0.009
74060104|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-78.1|-45.4||||||Serotype 1- Difference in positive response, Group A2 minus Group B||-45.4|-78.1|
74060105|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-70.6|-35.3||||||Serotype 2- Difference in positive response, Group A2 minus Group B||-35.3|-70.6|
74060106|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-55.9|||||TWO_SIDED|95.0|-75.3|-36.5||||||Serotype 3- Difference in positive response, Group A2 minus Group B||-36.5|-75.3|
74060107|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-64.7|||||TWO_SIDED|95.0|-82.6|-46.8||||||Serotype 4- Difference in positive response, Group A2 minus Group B||-46.8|-82.6|
74060108|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-70.6|-35.3||||||Serotype 5- Difference in positive response, Group A2 minus Group B||-35.3|-70.6|
74060109|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-59.3|-17.2||||||Serotype 6B- Difference in positive response, Group A2 minus Group B||-17.2|-59.3|
74060110|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-76.7|-40.9||||||Serotype 7F- Difference in positive response, Group A2 minus Group B||-40.9|-76.7|
74060111|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-29.4|||||TWO_SIDED|95.0|-46.1|-12.7||||||Serotype 8- Difference in positive response, Group A2 minus Group B||-12.7|-46.1|
74060112|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-35.3|||||TWO_SIDED|95.0|-56.4|-14.2||||||Serotype 9N- Difference in positive response, Group A2 minus Group B||-14.2|-56.4|
73881959|NCT00300755|147297754|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.||||0.004
73881960|NCT00300755|147297754|SUPERIORITY_OR_OTHER|||||||0.044|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.||||0.044
74060113|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-58.2|-18.2||||||Serotype 9V- Difference in positive response, Group A2 minus Group B||-18.2|-58.2|
74060114|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-79.8|-43.7||||||Serotype 10A- Difference in positive response, Group A2 minus Group B||-43.7|-79.8|
74060115|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-59.3|-17.2||||||Serotype 11A- Difference in positive response, Group A2 minus Group B||-17.2|-59.3|
74060116|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-78.0|-39.6||||||Serotype 12F- Difference in positive response, Group A2 minus Group B||-39.6|-78.0|
74060117|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-17.6|||||TWO_SIDED|95.0|-37.4|2.1||||||Serotype 14- Difference in positive response, Group A2 minus Group B||2.1|-37.4|
74060118|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-50.0|||||TWO_SIDED|95.0|-69.6|-30.4||||||Serotype 15B- Difference in positive response, Group A2 minus Group B||-30.4|-69.6|
74060119|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-44.1|||||TWO_SIDED|95.0|-64.0|-24.2||||||Serotype 17F- Difference in positive response, Group A2 minus Group B||-24.2|-64.0|
74060120|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-79.4|-44.2||||||Serotype 18C- Difference in positive response, Group A2 minus Group B||-44.2|-79.4|
74060121|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-72.3|-33.6||||||Serotype 19A- Difference in positive response, Group A2 minus Group B||-33.6|-72.3|
74060122|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-77.6|-40.1||||||Serotype 19F- Difference in positive response, Group A2 minus Group B||-40.1|-77.6|
74060123|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-70.6|||||TWO_SIDED|95.0|-87.4|-53.8||||||Serotype 20- Difference in positive response, Group A2 minus Group B||-53.8|-87.4|
74060124|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-67.6|||||TWO_SIDED|95.0|-84.8|-50.5||||||Serotype 22F- Difference in positive response, Group A2 minus Group B||-50.5|-84.8|
74060125|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-47.1|||||TWO_SIDED|95.0|-68.0|-26.1||||||Serotype 23F- Difference in positive response, Group A2 minus Group B||-26.1|-68.0|
74060126|NCT02545868|147673076|SUPERIORITY||Normal Distribution Approximation|-50.0|||||TWO_SIDED|95.0|-68.5|-31.5||||||Serotype 33F- Difference in positive response, Group A2 minus Group B||-31.5|-68.5|
74060127|NCT02545868|147673078|SUPERIORITY||Normal Distribution Approximation|-25.5|||||TWO_SIDED|95.0|-41.6|-9.5||||||Strain = H1N1CA09 (Group A2 minus Group B)||-9.5|-41.6|
73881961|NCT00300755|147297754|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.002
73881962|NCT00300755|147297754|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.026
73881963|NCT00300755|147297754|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.026
73881964|NCT00300755|147297755|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Cough without cold.||||0.004
74060128|NCT02545868|147673078|SUPERIORITY||Normal Distribution Approximation|-14.0|||||TWO_SIDED|95.0|-35.2|7.3||||||Strain = BPHU13 (Group A2 minus Group B)||7.3|-35.2|
74060129|NCT02545868|147673078|SUPERIORITY||Normal Distribution Approximation|-25.9|||||TWO_SIDED|95.0|-45.5|-6.4||||||Strain = H3N2SW13 (Group A2 minus Group B)||-6.4|-45.5|
74060130|NCT02545868|147673078|SUPERIORITY||Normal Distribution Approximation|-19.4|||||TWO_SIDED|95.0|-50.7|11.8||||||Strain = BBRIS08 (Group A2 minus Group B)||11.8|-50.7|
74060131|NCT02545868|147673078|SUPERIORITY||Normal Distribution Approximation|-3.3|||||TWO_SIDED|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)||42.7|-49.4|
74060132|NCT02545868|147673079|SUPERIORITY||Normal Distribution Approximation|-41.8|||||TWO_SIDED|95.0|-61.9|-21.7||||||Strain = H1N1CA09 (Group A2 minus Group B)||-21.7|-61.9|
74060133|NCT02545868|147673079|SUPERIORITY||Normal Distribution Approximation|-37.6|||||TWO_SIDED|95.0|-59.7|-15.5||||||Strain = BPHU13 (Group A2 minus Group B)||-15.5|-59.7|
74060134|NCT02545868|147673079|SUPERIORITY||Normal Distribution Approximation|-59.5|||||TWO_SIDED|95.0|-78.2|-40.7||||||Strain = H3N2SW13 (Group A2 minus Group B)||-40.7|-78.2|
74060135|NCT02545868|147673079|SUPERIORITY||Normal Distribution Approximation|-45.6|||||TWO_SIDED|95.0|-76.0|-15.1||||||Strain = BBRIS08 (Group A2 minus Group B)||-15.1|-76.0|
74060136|NCT02545868|147673079|SUPERIORITY||Normal Distribution Approximation|-3.3|||||TWO_SIDED|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)||42.7|-49.4|
74060137|NCT02545868|147673080|SUPERIORITY||Normal Distribution Approximation|-61.3|||||TWO_SIDED|95.0|-80.2|-42.3||||||Strain = H1N1CA09 - Difference in at least 4-fold response, Group A2 minus Group B||-42.3|-80.2|
74060138|NCT02545868|147673080|SUPERIORITY||Normal Distribution Approximation|-54.8|||||TWO_SIDED|95.0|-75.3|-34.4||||||Strain = BPHU13 - Difference in at least 4-fold response, Group A2 minus Group B||-34.4|-75.3|
74060139|NCT02545868|147673080|SUPERIORITY||Normal Distribution Approximation|-82.3|||||TWO_SIDED|95.0|-97.1|-67.5||||||Strain = H3N2SW13 - Difference in at least 4-fold response, Group A2 minus Group B||-67.5|-97.1|
74060140|NCT02545868|147673080|SUPERIORITY||Normal Distribution Approximation|-36.7|||||TWO_SIDED|95.0|-67.2|-6.1||||||Strain = BBRIS08 - Difference in at least 4-fold response, Group A2 minus Group B||-6.1|-67.2|
74060141|NCT02545868|147673080|SUPERIORITY||Normal Distribution Approximation|-6.7|||||TWO_SIDED|95.0|-63.8|50.5||||||Strain = AHK4801 - Difference in at least 4-fold response, Group A2 minus Group B||50.5|-63.8|
74060142|NCT02545868|147673081|SUPERIORITY||Normal Distribution Approximation|-61.3|||||TWO_SIDED|95.0|-80.2|-42.3||||||Strain = H1N1CA09 (Group A2 minus Group B) \[FDA\]||-42.3|-80.2|
74060143|NCT02545868|147673081|SUPERIORITY||Normal Distribution Approximation|-46.0|||||TWO_SIDED|95.0|-88.0|-4.0||||||Strain = H1N1CA09 (Group A2 minus Group B) \[Protocol\]||-4.0|-88.0|
74060144|NCT02545868|147673081|SUPERIORITY||Normal Distribution Approximation|-57.9|||||TWO_SIDED|95.0|-77.7|-38.1||||||Strain = BPHU13 (Group A2 minus Group B) \[FDA\]||-38.1|-77.7|
74060145|NCT02545868|147673081|SUPERIORITY||Normal Distribution Approximation|-55.6|||||TWO_SIDED|95.0|-88.0|-23.1||||||Strain = BPHU13 (Group A2 minus Group B) \[Protocol\]||-23.1|-88.0|
74060146|NCT02545868|147673081|SUPERIORITY||Normal Distribution Approximation|-78.5|||||TWO_SIDED|95.0|-94.8|-62.2||||||Strain = H3N2SW13 (Group A2 minus Group B) \[FDA\]||-62.2|-94.8|
74060147|NCT02545868|147673081|SUPERIORITY||Normal Distribution Approximation|-57.8|||||TWO_SIDED|95.0|-100.0|-13.4||||||Strain = H3N2SW13 (Group A2 minus Group B) \[Protocol\]||-13.4|-100.0|
74060148|NCT02545868|147673081|SUPERIORITY||Normal Distribution Approximation|-36.7|||||TWO_SIDED|95.0|-67.2|-6.1||||||Strain = BBRIS08 (Group A2 minus Group B) \[FDA\]||-6.1|-67.2|
74060149|NCT02545868|147673081|SUPERIORITY||Normal Distribution Approximation|-25.0|||||TWO_SIDED|95.0|-67.4|17.4||||||Strain = BBRIS08 (Group A2 minus Group B) \[Protocol\]||17.4|-67.4|
74060150|NCT02545868|147673081|SUPERIORITY||Normal Distribution Approximation|-6.7|||||TWO_SIDED|95.0|-63.8|50.5||||||Strain = AHK4801 (Group A2 minus Group B) \[FDA\]||50.5|-63.8|
74060151|NCT01932801|147673098|SUPERIORITY|||||||0.461||||||Denotes exact fit for the omnibus model|Chi-squared|Complete omnibus model stats: χ2(18, N=308) = 17.93, CFI = 1.00, RMSEA \< .001, SRMR = .07||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.461
74060152|NCT01932801|147673098|SUPERIORITY||Slope|-0.48||||0.01|TWO_SIDED|95.0|-0.79|-0.18||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period|z score for parameters||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.18|-.79|.01
74060153|NCT01932801|147673098|SUPERIORITY||Slope|-0.41||||0.01|TWO_SIDED|95.0|-0.67|-0.15|||z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables) during treatment period|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.15|-.67|.01
74060154|NCT01932801|147673098|SUPERIORITY||Slope|-0.23||||0.19|TWO_SIDED|95.0|-0.52|0.06|||z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables) during treatment period|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||.06|-.52|.19
74102070|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.129||0.1593|TWO_SIDED|95.0|-0.44|0.07|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.44|0.1593
74102071|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6371|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6371
74060155|NCT01932801|147673099|SUPERIORITY|||||||0.347||||||Denotes exact fit for the omnibus model|Chi-squared|complete omnibus model statistics: χ2(20, N=308) = 21.89, CFI = 1.00, RMSEA = .02, SRMR = .03||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.347
74060156|NCT01932801|147673099|SUPERIORITY||Slope|-2.22||||0.002|TWO_SIDED|95.0|-3.39|-1.06||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-1.06|-3.39|.002
74060157|NCT01932801|147673099|SUPERIORITY||Slope|-0.82||||0.208|TWO_SIDED|95.0|-1.89|0.25||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||.25|-1.89|.208
74060158|NCT01932801|147673099|SUPERIORITY||Slope|-1.58||||0.025|TWO_SIDED|95.0|-2.73|-0.42||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.42|-2.73|.025
74060159|NCT01932801|147673100|SUPERIORITY|||||||0.028||||||"p value reflects omnibus model close fit"|Chi-squared|χ2(13, N=308) = 24.34, CFI = .98, RMSEA = .05, SRMR = .03||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.028
74060160|NCT01932801|147673100|SUPERIORITY||Slope|-4.42||||0.047|TWO_SIDED|95.0|-8.09|-0.76||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.76|-8.09|.047
74060161|NCT01932801|147673100|SUPERIORITY||Slope|-5.95||||0.009|TWO_SIDED|95.0|-9.72|-2.19||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-2.19|-9.72|.009
74060162|NCT01932801|147673100|SUPERIORITY||Slope|-4.12||||0.072|TWO_SIDED|95.0|-7.88|-0.36||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.36|-7.88|.072
74060163|NCT01932801|147673101|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.24||0.6|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.6
74102072|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.124||0.5655|TWO_SIDED|95.0|-0.32|0.18|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.32|0.5655
74102073|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.121||0.3326|TWO_SIDED|95.0|-0.12|0.36|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.12|0.3326
73881965|NCT00300755|147297755|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Noisy breathing.||||0.047
73881966|NCT03192826|147297757|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
73881967|NCT03192826|147297758|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
73881968|NCT03192826|147297759|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
74060164|NCT01932801|147673101|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.18||0.83|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.83
74060165|NCT01932801|147673101|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.89|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.89
73881969|NCT03192826|147297760|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
73881970|NCT02694744|147297761|OTHER||||||||||||||||||If the 95% confidence interval for the w/out food Arm overlapped the confidence interval for the w/ food Arm, the study will conclude that there is no evidence of a statistically significant difference between treatment arms.|||
73881971|NCT02694744|147297762|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.7893|TWO_SIDED|95.0|-0.17|0.22|||ANCOVA|||Estimation of mean change in serum potassium from Baseline to week 4.||0.22|-0.17|0.7893
73881972|NCT02174731|147297790|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% confidence interval (CI) of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|0.01|0.18|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean changes.|||0.18|0.01|<0.001
74102074|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.201||0.3577|TWO_SIDED|95.0|-0.59|0.22|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.59|0.3577
74102075|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.192||0.1646|TWO_SIDED|95.0|-0.66|0.11|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.66|0.1646
74102076|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.118||0.0545|TWO_SIDED|95.0|-0.46|0.0|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.46|0.0545
74102077|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.115||0.2903|TWO_SIDED|95.0|-0.35|0.11|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.35|0.2903
74102078|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.112||0.0395|TWO_SIDED|95.0|0.01|0.45|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|0.01|0.0395
74060166|NCT01932801|147673101|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.65|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.65
74060167|NCT01932801|147673101|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.87|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the placebo vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.87
74102079|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.108||0.469|TWO_SIDED|95.0|-0.14|0.29|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.14|0.4690
74060168|NCT01932801|147673101|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.02||0.91|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.91
74060169|NCT01932801|147673101|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.24|STANDARD_ERROR_OF_MEAN|0.38||0.54|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol related harm.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.54
74060170|NCT01932801|147673101|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.06|STANDARD_ERROR_OF_MEAN|0.32||0.84|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the placebo vs control effects on alcohol-related harm.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.84
74060171|NCT01932801|147673101|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.06|STANDARD_ERROR_OF_MEAN|0.29||0.84|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol related harm|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.84
74060172|NCT01932801|147673102|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.9||0.65|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails two treatment arms: XR-NTX vs placebo effects on alcohol frequency and alcohol craving (PACS).|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of the craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.65
74060173|NCT01932801|147673102|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.46|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails 2 treatment arms: XR-NTX vs placebo effects on craving and alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of the alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.46
74102080|NCT02942004|147754082|SUPERIORITY||LS difference|0.07|STANDARD_ERROR_OF_MEAN|0.139||0.6066|TWO_SIDED|95.0|-0.2|0.35|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.20|0.6066
74060174|NCT01932801|147673102|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.57|STANDARD_ERROR_OF_MEAN|0.75||0.45|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails two treatment arms: XR-NTX vs placebo effects on craving and alcohol-related harm|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.45
74060175|NCT01932801|147673103|SUPERIORITY|||||||0.95||||||Denotes exact fit for the omnibus model|Chi-squared|Complete omnibus model : χ2(12, N=308) = .75, CFI = 1.00, RMSEA \< .001, SRMR = .008||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.95
74060176|NCT01932801|147673103|SUPERIORITY||Slope|-0.04||||0.75|TWO_SIDED|95.0|-0.24|0.16||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|Chi-squared|||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.16|-.24|.75
74060177|NCT01932801|147673103|SUPERIORITY||Slope|-0.15||||0.2|TWO_SIDED|95.0|-0.34|0.04|||Chi-squared|Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.04|-.34|.20
74060178|NCT01932801|147673103|SUPERIORITY||Slope|0.1||||0.39|TWO_SIDED|95.0|-0.09|0.29|||Chi-squared|Linear effects of HaRT-A compared to services-as usual control during treatment period (one of three dummy-coded variables)||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.29|-.09|.39
74060179|NCT01932801|147673104|SUPERIORITY||incident rate ratio|0.98|||>|0.84|TWO_SIDED|95.0|0.83|1.16|||z|||We conducted a generalized estimating equations analysis (negative binomial distribution, log link) to test whether number of adverse events reported increased from baseline to the follow-ups differentially across placebo and XR-NTX groups||1.16|.83|>.84
74060180|NCT00448630|147673107|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.||||<0.001
74060181|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.490
74060182|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
74060183|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.006
74060184|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
74060185|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.003
74102081|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.136||0.9737|TWO_SIDED|95.0|-0.26|0.27|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.26|0.9737
74060186|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
74060187|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.050
74060188|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0012
74060189|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0078
74060190|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
73881973|NCT02174731|147297791|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.056|<|0.001|TWO_SIDED|95.0|0.03|0.25|||MMRM||Difference between groups (roxadustat minus Epoetin alfa) in LS mean change.|||0.25|0.03|<0.001
74060191|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0133
74060192|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0142||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0142
74060193|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0265||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0265
73881974|NCT02174731|147297792|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.0|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.05|0.00|<0.001
74060194|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1613||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1613
74060195|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2644||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2644
74060196|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||5e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000005
74060197|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7385||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7385
74102082|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.148||0.403|TWO_SIDED|95.0|-0.17|0.42|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.17|0.4030
74102083|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.145||0.6357|TWO_SIDED|95.0|-0.36|0.22|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.36|0.6357
74102084|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.134||0.8605|TWO_SIDED|95.0|-0.29|0.24|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.29|0.8605
74102085|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7534|TWO_SIDED|95.0|-0.3|0.22|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.30|0.7534
74102086|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.201||0.0021|TWO_SIDED|95.0|-1.03|-0.23|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-1.03|0.0021
74102087|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.196||0.0394|TWO_SIDED|95.0|-0.8|-0.02|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.80|0.0394
74102088|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.208||0.0039|TWO_SIDED|95.0|-1.03|-0.2|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-1.03|0.0039
73881975|NCT02174731|147297793|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.014|<|0.001|TWO_SIDED|95.0|-0.01|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.05|-0.01|<0.001
74102089|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.202||0.1591|TWO_SIDED|95.0|-0.69|0.11|||MMRM|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.69|0.1591
74102090|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.21||0.1402|TWO_SIDED|95.0|-0.73|0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.73|0.1402
74102091|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.205||0.0143|TWO_SIDED|95.0|-0.91|-0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.91|0.0143
74102092|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.204||0.2293|TWO_SIDED|95.0|-0.65|0.16|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.65|0.2293
74102093|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.0884|TWO_SIDED|95.0|-0.74|0.05|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.74|0.0884
74102094|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.207||0.0622|TWO_SIDED|95.0|-0.8|0.02|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.80|0.0622
74102095|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.202||0.0955|TWO_SIDED|95.0|-0.74|0.06|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.74|0.0955
74060198|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
74060199|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6813||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6813
74060200|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0024
74060201|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2237||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2237
74060202|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5774||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5774
74060203|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000001
74060204|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2502||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2502
74060205|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5224||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5224
74060206|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
74060207|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
74060208|NCT00448630|147673108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8166||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8166
74060209|NCT00448630|147673109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.||||<0.001
74060210|NCT00448630|147673110|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||<0.001
74102096|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.21||0.0173|TWO_SIDED|95.0|-0.92|-0.09|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.92|0.0173
74060211|NCT00448630|147673111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.544||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.544
74060212|NCT00448630|147673112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.245
74060213|NCT00448630|147673113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.362
74060214|NCT00448630|147673114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.176
74060215|NCT00448630|147673115|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||<0.001
74060216|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.524||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.524
74060217|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
74060218|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.005
74060219|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
74060220|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.009
74060221|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
74060222|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.047
74060223|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0007
74060224|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0057||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0057
74060225|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00009
74060226|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0201||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0201
74060227|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0095||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0095
74060228|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0386
74060229|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1976||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1976
74060230|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2383||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2383
74060231|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||2e-05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00002
74060232|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8297||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8297
74060233|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9081||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9081
74060234|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7386
74060235|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0024
74060236|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2587||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2587
74060237|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6263||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6263
74060238|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000001
74060239|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2589||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2589
74060240|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5153||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5153
74060241|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0003
74060242|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0005
74060243|NCT00448630|147673116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8952||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8952
74060244|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.197
74060245|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.010
74060246|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.012
74060247|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
74060248|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.282||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.282
74060249|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.040
74060250|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.004
74060251|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0193||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0193
74060252|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0065||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0065
74060253|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
74060254|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3172||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3172
74060255|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0116||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0116
74060256|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0016
74060257|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2600
74060258|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2309||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2309
74060259|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0063
74060260|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8158||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8158
74060261|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3968||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3968
74060262|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7193||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7193
74060263|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0127
74060264|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2351||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2351
74060265|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5672||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5672
74060266|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00009
74060267|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1774||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1774
74060268|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6082||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6082
74060269|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
74060270|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0014
74060271|NCT00448630|147673117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5587||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5587
74060272|NCT00448630|147673118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.077
74060273|NCT00448630|147673118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.039
74060274|NCT00448630|147673118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.978||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.978
74060275|NCT00448630|147673118|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
74060276|NCT00448630|147673118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.593||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.593
74102097|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.206||0.1687|TWO_SIDED|95.0|-0.69|0.12|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.69|0.1687
74102098|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.258||0.3861|TWO_SIDED|95.0|-0.74|0.29|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.74|0.3861
74102099|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.249||0.706|TWO_SIDED|95.0|-0.59|0.4|||MMRM|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.59|0.7060
74102100|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.0112|TWO_SIDED|95.0|-1.05|-0.14|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-1.05|0.0112
74102101|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.219||0.057|TWO_SIDED|95.0|-0.86|0.01|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.86|0.0570
74102102|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.208||0.0018|TWO_SIDED|95.0|-1.08|-0.26|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.26|-1.08|0.0018
74102103|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.205||0.0443|TWO_SIDED|95.0|-0.83|-0.01|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.83|0.0443
74102104|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.104||0.1197|TWO_SIDED|95.0|-0.04|0.37|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.04|0.1197
74102105|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.101||0.7171|TWO_SIDED|95.0|-0.24|0.16|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.24|0.7171
74102106|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.7151|TWO_SIDED|95.0|-0.32|0.22|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.32|0.7151
74102107|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.134||0.521|TWO_SIDED|95.0|-0.35|0.18|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.35|0.5210
74102108|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.142||0.7332|TWO_SIDED|95.0|-0.23|0.33|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.23|0.7332
74060277|NCT00448630|147673118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.987||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.987
74060278|NCT00448630|147673118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.174
74060279|NCT00388674|147673138|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.3553|TWO_SIDED|95.03|0.8|1.084|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.084|0.800|0.3553
74060280|NCT00388674|147673139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0676|TWO_SIDED|95.03|0.713|1.012|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.012|0.713|0.0676
74102109|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.139||0.4163|TWO_SIDED|95.0|-0.39|0.16|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.39|0.4163
74102110|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.132||0.8625|TWO_SIDED|95.0|-0.28|0.24|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.28|0.8625
74102111|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6196|TWO_SIDED|95.0|-0.32|0.19|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.32|0.6196
74102112|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.197||0.0373|TWO_SIDED|95.0|-0.8|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.80|0.0373
74102113|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.191||0.0644|TWO_SIDED|95.0|-0.74|0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.74|0.0644
74102114|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.191||0.1347|TWO_SIDED|95.0|-0.66|0.09|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.66|0.1347
74102115|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.185||0.1269|TWO_SIDED|95.0|-0.65|0.08|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.65|0.1269
74102116|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.192||0.165|TWO_SIDED|95.0|-0.65|0.11|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.65|0.1650
74060281|NCT00388674|147673140|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1182|TWO_SIDED|95.03|0.769|1.03|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.030|0.769|0.1182
74060282|NCT00388674|147673141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.817|1.478|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.478|0.817|
74060283|NCT00388674|147673142|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.727|1.032|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.032|0.727|
74060284|NCT00388674|147673143|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.608|1.365|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.365|0.608|
74060285|NCT00568776|147673144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.71|TWO_SIDED|95.0|-0.14|0.21|||Mixed Models Analysis|||||0.21|-0.14|0.71
74102117|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.188||0.1291|TWO_SIDED|95.0|-0.66|0.08|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.66|0.1291
74102118|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.189||0.0402|TWO_SIDED|95.0|-0.77|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.77|0.0402
74102119|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.185||0.0342|TWO_SIDED|95.0|-0.76|-0.03|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.76|0.0342
74102120|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.193||0.1269|TWO_SIDED|95.0|-0.68|0.09|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.68|0.1269
74102121|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.188||0.3945|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3945
74102122|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.185||0.5828|TWO_SIDED|95.0|-0.47|0.26|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.47|0.5828
74102123|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.182||0.6625|TWO_SIDED|95.0|-0.28|0.44|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.28|0.6625
74102124|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.216||0.0041|TWO_SIDED|95.0|-1.07|-0.21|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.21|-1.07|0.0041
74102125|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.21||0.2222|TWO_SIDED|95.0|-0.67|0.16|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.67|0.2222
74102126|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.218||0.0245|TWO_SIDED|95.0|-0.93|-0.07|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.93|0.0245
74102127|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.209||0.5119|TWO_SIDED|95.0|-0.55|0.28|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.55|0.5119
74102128|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.197||0.0299|TWO_SIDED|95.0|-0.82|-0.04|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.82|0.0299
74102129|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.195||0.2824|TWO_SIDED|95.0|-0.6|0.18|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.60|0.2824
74102130|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.129||0.1768|TWO_SIDED|95.0|-0.08|0.43|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.08|0.1768
74102131|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6498|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6498
74102132|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.7689|TWO_SIDED|95.0|-0.25|0.34|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.25|0.7689
74102133|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.146||0.2236|TWO_SIDED|95.0|-0.47|0.11|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.47|0.2236
74102134|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.148||0.6952|TWO_SIDED|95.0|-0.35|0.23|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.35|0.6952
74102135|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.144||0.1184|TWO_SIDED|95.0|-0.51|0.06|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.51|0.1184
74102136|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.149||0.3031|TWO_SIDED|95.0|-0.14|0.45|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.14|0.3031
74102137|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.145||0.3091|TWO_SIDED|95.0|-0.44|0.14|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.44|0.3091
74060286|NCT00568776|147673145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|1.9||0.18|TWO_SIDED|95.0|-6.33|1.22|||Mixed Models Analysis|||||1.22|-6.33|0.18
74060287|NCT00568776|147673146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED|95.0|-0.06|0.36|||Mixed Models Analysis|||||0.36|-0.06|0.17
74060288|NCT00568776|147673147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|2.03||0.49|TWO_SIDED|95.0|-5.41|2.62|||Mixed Models Analysis|||||2.62|-5.41|0.49
74060289|NCT00568776|147673148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|2.2||0.77|TWO_SIDED|95.0|-3.73|5.03|||Mixed Models Analysis|||||5.03|-3.73|0.77
74060290|NCT00568776|147673149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.47||0.54|TWO_SIDED|95.0|-0.63|1.21|||Mixed Models Analysis|||||1.21|-0.63|0.54
74060291|NCT00568776|147673150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|2.24||0.65|TWO_SIDED|95.0|-3.43|5.46|||Mixed Models Analysis|||||5.46|-3.43|0.65
74060292|NCT01005680|147673151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.822|TWO_SIDED|95.0|0.77|1.39||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex, and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.39|0.77|0.822
74102138|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.179||0.1525|TWO_SIDED|95.0|-0.61|0.1|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.61|0.1525
74060293|NCT01005680|147673152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.64|TWO_SIDED|95.0|0.82|1.37||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.37|0.82|0.640
74060294|NCT01005680|147673153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.78|1.32||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and biases for initial pathological diagnosis.|Cox Proportional Hazard|||||1.32|0.78|0.928
74060295|NCT01005680|147673154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.887|TWO_SIDED|95.0|0.51|1.79||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.79|0.51|0.887
74060296|NCT01005680|147673155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.861|TWO_SIDED|95.0|0.67|1.61||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.61|0.67|0.861
74060297|NCT01005680|147673156|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||two-sided Z test|||||||0.451
74060298|NCT01005680|147673158|SUPERIORITY_OR_OTHER|||||||0.627||95.0|||||two-sided Z test|||||||0.627
74060299|NCT00996632|147673160|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||null hypothesis is that drainage volumes are not different||||<0.05
74060300|NCT00996632|147673161|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||null hypothesis is that Stay in Hospital Days are not different||||0.05
74060301|NCT02118896|147673196|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9257|||||TWO_SIDED|95.0|0.844|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.844|
74060302|NCT02118896|147673196|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9321|||||TWO_SIDED|95.0|0.858|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.858|
74060303|NCT02118896|147673196|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
74060304|NCT02118896|147673196|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8699|||||TWO_SIDED|95.0|0.79|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||0.949|0.790|
74060305|NCT02118896|147673196|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9607|||||TWO_SIDED|95.0|0.927|0.995||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||0.995|0.927|
74060306|NCT02118896|147673196|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9948|||||TWO_SIDED|95.0|0.985|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.985|
74060307|NCT02118896|147673196|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
74060308|NCT02118896|147673196|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
74060309|NCT02118896|147673196|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9773|||||TWO_SIDED|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.933|
74060310|NCT02118896|147673199|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8391|||||TWO_SIDED|95.0|0.729|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.949|0.729|
74060311|NCT02118896|147673199|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8792|||||TWO_SIDED|95.0|0.778|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula..||0.981|0.778|
74060312|NCT02118896|147673199|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8816|||||TWO_SIDED|95.0|0.782|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.981|0.782|
74060313|NCT02118896|147673199|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.7769|||||TWO_SIDED|95.0|0.675|0.878||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.878|0.675|
74060314|NCT02118896|147673199|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8373|||||TWO_SIDED|95.0|0.693|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.981|0.693|
74060315|NCT02118896|147673199|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9419|||||TWO_SIDED|95.0|0.883|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.883|
74060316|NCT02118896|147673199|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|1.000|
74060317|NCT02118896|147673199|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9898|||||TWO_SIDED|95.0|0.97|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.970|
74060318|NCT02118896|147673199|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9773|||||TWO_SIDED|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.933|
74060319|NCT03901352|147673200|SUPERIORITY||Difference of LSM vs placebo|-0.71|STANDARD_ERROR_OF_MEAN|0.187||0.0001|TWO_SIDED|95.0|-1.08|-0.34|||ANCOVA||"The multiple imputation (MI) was based on a nonfuture dependence model using the pattern mixture model (PMM) approach with shifting parameters under the missing not at random (MNAR0 mechanism for the missing weekly ADPS."|||-0.34|-1.08|0.0001
74060320|NCT02050373|147673246|OTHER|For the comparison between the LLLT and control groups the Pearson chi-square (χ2) or Fisher's Exact tests were used.|||||<|0.05|||||||Fisher Exact|||The Pearson chi-square (χ2) or Fisher's Exact tests were used, at three different times (AD, D7, HD), to analyze the oral mucositis severity in the comparison between the LLLT and control groups. Statistical analysis was not performed for each grade of oral mucositis separately.||||<0.05
74060321|NCT02050373|147673247|OTHER|Student's t test was used to numerical variables with normal distribution. The Mann-Whitney test was used to compare the cytokine values of the two groups (control and laser). The Friedman test was used to indicate differences by comparing cytokine levels at different times of assessment within each group. The Friedman and Wilcoxon tests were used for paired analyzes of the saliva collection times in the groups. All tests were used to compare the groups at the three different times (AD, D7, HD).|||||<|0.05||||||p\<0,05|Wilcoxon (Mann-Whitney)|||||||<0.05
74060322|NCT04342130|147673248|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
74060323|NCT03901339|147673252|OTHER||Hazard Ratio (HR)|0.653||||0.0001|TWO_SIDED|95.0|0.526|0.812||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.812|0.526|0.0001
74060324|NCT03901339|147673253|OTHER||Hazard Ratio (HR)|0.788||||0.0133|TWO_SIDED|95.0|0.652|0.952||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.952|0.652|0.0133
74060325|NCT03901339|147673254|OTHER||Odds Ratio (OR)|1.662||||0.0268|TWO_SIDED|95.0|1.058|2.609|||Cochran-Mantel-Haenszel|||ORR by BICR Assessment||2.609|1.058|0.0268
74060326|NCT03901339|147673254|OTHER||Odds Ratio (OR)|1.989||||0.0098|TWO_SIDED|95.0|1.174|3.369|||Cochran-Mantel-Haenszel|||ORR by LIR Assessment||3.369|1.174|0.0098
74060327|NCT03901339|147673256|OTHER||Odds Ratio (OR)|1.796||||0.0025|TWO_SIDED|95.0|1.227|2.628|||Cochran-Mantel-Haenszel|||CBR by BICR Assessment||2.628|1.227|0.0025
74060328|NCT03901339|147673256|OTHER||Odds Ratio (OR)|1.834||||0.0024|TWO_SIDED|95.0|1.237|2.717|||Cochran-Mantel-Haenszel|||CBR by LIR Assessment||2.717|1.237|0.0024
74060329|NCT03901339|147673257|OTHER||Hazard Ratio (HR)|0.728||||0.001|TWO_SIDED|95.0|0.602|0.881||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.881|0.602|0.0010
74060330|NCT03901339|147673258|OTHER||Hazard Ratio (HR)|0.751||||0.0059|TWO_SIDED|95.0|0.612|0.922||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.922|0.612|0.0059
74060331|NCT03901339|147673259|OTHER||Hazard Ratio (HR)|0.918||||0.4151|TWO_SIDED|95.0|0.748|1.126||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||1.126|0.748|0.4151
74060332|NCT03901339|147673260|OTHER||Hazard Ratio (HR)|0.732||||0.0021|TWO_SIDED|95.0|0.598|0.894||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.894|0.598|0.0021
74060333|NCT01785472|147673289|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test was made at a one-sided significance level of 0.025.|least Square Means net difference|-2.33|STANDARD_ERROR_OF_MEAN|0.85|<|0.001||95.0|-4.0|-0.66|||ANCOVA|||||-0.66|-4.00|<0.001
74060334|NCT01211873|147673313|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
74102139|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.174||0.1214|TWO_SIDED|95.0|-0.62|0.07|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.62|0.1214
74102140|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.187||0.3811|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3811
74102141|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.3851|TWO_SIDED|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.51|0.3851
74102142|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.182||0.1373|TWO_SIDED|95.0|-0.63|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.63|0.1373
74102143|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.177||0.136|TWO_SIDED|95.0|-0.62|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.62|0.1360
74102144|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.176||0.1264|TWO_SIDED|95.0|-0.62|0.08|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.62|0.1264
74102145|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.172||0.0567|TWO_SIDED|95.0|-0.67|0.01|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.67|0.0567
74102146|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.176||0.7447|TWO_SIDED|95.0|-0.41|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.41|0.7447
74060335|NCT01211873|147673314|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
74060336|NCT01211873|147673314|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
74060337|NCT01211873|147673315|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
74060338|NCT01211873|147673315|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
74060339|NCT01569074|147673317|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.23||||0.059|TWO_SIDED|80.0|0.07|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||0.39|0.07|0.059
74102147|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.172||0.7727|TWO_SIDED|95.0|-0.39|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.39|0.7727
74102148|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.183||0.659|TWO_SIDED|95.0|-0.28|0.44|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.28|0.6590
74102149|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.3951|TWO_SIDED|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.51|0.3951
74102150|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4576|TWO_SIDED|95.0|-0.63|0.28|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.63|0.4576
74102151|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.223||0.7609|TWO_SIDED|95.0|-0.51|0.37|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.51|0.7609
74102152|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.234||0.622|TWO_SIDED|95.0|-0.58|0.35|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.58|0.6220
74102153|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.225||0.9081|TWO_SIDED|95.0|-0.42|0.47|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.42|0.9081
74102154|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.191||0.1668|TWO_SIDED|95.0|-0.65|0.11|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.65|0.1668
74102155|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.189||0.0935|TWO_SIDED|95.0|-0.69|0.05|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.69|0.0935
74102156|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.15||0.4038|TWO_SIDED|95.0|-0.42|0.17|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.42|0.4038
74102157|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.145||0.7559|TWO_SIDED|95.0|-0.24|0.33|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.24|0.7559
74102158|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.181||0.2006|TWO_SIDED|95.0|-0.59|0.13|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.59|0.2006
73881976|NCT02174731|147297794|SUPERIORITY|Superiority was also declared as the lower bound of the 95% CI exceeded 0 and p-value was lower than 0.05.|Least Square Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.39|-0.27|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||-0.27|-0.39|<0.001
74102159|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.175||0.6334|TWO_SIDED|95.0|-0.26|0.43|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.26|0.6334
74102160|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.5431|TWO_SIDED|95.0|-0.6|0.32|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.60|0.5431
74102161|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.225||0.5278|TWO_SIDED|95.0|-0.3|0.59|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.59|-0.30|0.5278
74102162|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.232||0.4312|TWO_SIDED|95.0|-0.64|0.28|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.64|0.4312
74102163|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.225||0.3947|TWO_SIDED|95.0|-0.25|0.64|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.64|-0.25|0.3947
74102164|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.244||0.6081|TWO_SIDED|95.0|-0.61|0.36|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.61|0.6081
74102165|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.238||0.8949|TWO_SIDED|95.0|-0.44|0.5|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.50|-0.44|0.8949
74102166|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.236||0.112|TWO_SIDED|95.0|-0.84|0.09|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.84|0.1120
74102167|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.228||0.1842|TWO_SIDED|95.0|-0.15|0.76|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.76|-0.15|0.1842
74102168|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.26||0.2646|TWO_SIDED|95.0|-0.81|0.22|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.81|0.2646
74060340|NCT01569074|147673317|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.24||||0.054|TWO_SIDED|80.0|0.08|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.39|0.08|0.054
74060341|NCT01569074|147673317|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.06||||0.57|TWO_SIDED|80.0|-0.2|0.08||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.08|-0.20|0.570
74060342|NCT01569074|147673317|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.14||||0.262|TWO_SIDED|80.0|-0.02|0.29||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.29|-0.02|0.262
74060343|NCT01569074|147673318|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.11||||0.172|TWO_SIDED|80.0|0.01|0.21||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.21|0.01|0.172
74060344|NCT01569074|147673318|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.06||||0.489|TWO_SIDED|80.0|-0.05|0.18||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.18|-0.05|0.489
74060345|NCT01569074|147673318|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.03||||0.704|TWO_SIDED|80.0|-0.08|0.15||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.15|-0.08|0.704
74102169|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.253||0.8101|TWO_SIDED|95.0|-0.56|0.44|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.56|0.8101
74102170|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.248||0.0215|TWO_SIDED|95.0|-1.07|-0.09|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-1.07|0.0215
74060346|NCT01569074|147673319|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.17||||0.114|TWO_SIDED|80.0|0.03|0.31||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.31|0.03|0.114
74060347|NCT01569074|147673319|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.21||||0.035|TWO_SIDED|80.0|0.08|0.34||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.34|0.08|0.035
74060348|NCT01569074|147673319|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.07||||0.334|TWO_SIDED|80.0|-0.17|0.02||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.02|-0.17|0.334
74102171|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.242||0.3226|TWO_SIDED|95.0|-0.72|0.24|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.72|0.3226
74102172|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.238||0.0339|TWO_SIDED|95.0|-0.98|-0.04|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.98|0.0339
74102173|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.232||0.9824|TWO_SIDED|95.0|-0.46|0.47|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.46|0.9824
74102174|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.254||0.095|TWO_SIDED|95.0|-0.93|0.08|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.93|0.0950
74102175|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.249||0.4865|TWO_SIDED|95.0|-0.67|0.32|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.67|0.4865
74102176|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.292||0.9861|TWO_SIDED|95.0|-0.57|0.58|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|-0.57|0.9861
74102177|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.283||0.9266|TWO_SIDED|95.0|-0.59|0.54|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.54|-0.59|0.9266
74102178|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.285||0.036|TWO_SIDED|95.0|-1.17|-0.04|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-1.17|0.0360
74102179|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.273||0.0583|TWO_SIDED|95.0|-1.06|0.02|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-1.06|0.0583
74102180|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.254||0.0404|TWO_SIDED|95.0|-1.03|-0.02|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-1.03|0.0404
74102181|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.249||0.1352|TWO_SIDED|95.0|-0.87|0.12|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.87|0.1352
73881977|NCT02174731|147297795|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|0.04|0.36|||ANCOVA|MAR-based multiple imputation.|Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.36|0.04|<0.001
73881978|NCT02174731|147297796|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||||||<0.0001
74060349|NCT01569074|147673319|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.04||||0.645|TWO_SIDED|80.0|-0.13|0.06||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.06|-0.13|0.645
74060350|NCT01569074|147673320|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.12||||0.028|TWO_SIDED|80.0|0.05|0.19||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.19|0.05|0.028
74060351|NCT01569074|147673320|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.14||||0.021|TWO_SIDED|80.0|0.06|0.22||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.22|0.06|0.021
74060352|NCT01569074|147673321|SUPERIORITY_OR_OTHER|||||||0.073||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.073
74060353|NCT01569074|147673321|SUPERIORITY_OR_OTHER|||||||0.065||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.065
74060354|NCT01569074|147673321|SUPERIORITY_OR_OTHER|||||||0.317||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.317
74060355|NCT01569074|147673321|SUPERIORITY_OR_OTHER|||||||0.263||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.263
74102182|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.121||0.0056|TWO_SIDED|95.0|0.1|0.58|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|0.10|0.0056
74102183|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.118||0.1537|TWO_SIDED|95.0|-0.06|0.4|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.06|0.1537
74102184|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.129||0.0142|TWO_SIDED|95.0|0.07|0.58|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|0.07|0.0142
73881979|NCT02174731|147297797|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the upper bound of the HR 95% CI of the difference between roxadustat and epoetin alfa was less than or equal to 1.8. Non-inferiority p-value is 1-sided. The CIs were from Wald and ties were calculated using the Efron method.|Hazard Ratio (HR)|0.83|||<|0.001|TWO_SIDED|95.0|0.64|1.07|||Regression, Cox|||||1.07|0.64|<0.001
73881980|NCT02374164|147297857|SUPERIORITY_OR_OTHER||Point Estimate|0.72|||||TWO_SIDED|90.0|0.612|0.847|||||Ratio Fed/Fasted. Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural logarithm-transformed data. Bioequivalence was reached if the value was 0.80 to 1.25.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in the fasted and fed (high-fat meal) states.||0.847|0.612|
73881981|NCT01168349|147297865|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55|||||TWO_SIDED|95.0|0.42|0.71||||||||0.71|0.42|
73881982|NCT01168349|147297868|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
73881983|NCT03535974|147297895|OTHER||Mean Difference (Final Values)|10.57|STANDARD_ERROR_OF_MEAN|5.122||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
74060356|NCT01569074|147673322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.3||||0.033|TWO_SIDED|80.0|1.94|14.31|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||14.31|1.94|0.033
74060357|NCT01569074|147673322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.1||||0.033|TWO_SIDED|80.0|1.92|13.61|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||13.61|1.92|0.033
74060358|NCT01569074|147673322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.257|TWO_SIDED|80.0|0.89|6.89|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||6.89|0.89|0.257
74060359|NCT01569074|147673322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.481|TWO_SIDED|80.0|0.63|5.04|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.04|0.63|0.481
74060360|NCT01569074|147673323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.131|TWO_SIDED|80.0|1.12|4.2|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.20|1.12|0.131
74060361|NCT01569074|147673323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.423|TWO_SIDED|80.0|0.79|2.82|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||2.82|0.79|0.423
74060362|NCT01569074|147673323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.781|TWO_SIDED|80.0|0.45|1.67|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.67|0.45|0.781
74102185|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.126||0.0159|TWO_SIDED|95.0|0.06|0.56|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.56|0.06|0.0159
74102186|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.132||0.2255|TWO_SIDED|95.0|-0.1|0.42|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.10|0.2255
74102187|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.129||0.1069|TWO_SIDED|95.0|-0.05|0.46|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.05|0.1069
74102188|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.144||0.4932|TWO_SIDED|95.0|-0.19|0.39|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.19|0.4932
73881984|NCT00988884|147297922|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.88|1.08|||ANOVA|||Anti-HPV 6||1.08|0.88|<0.001
74060363|NCT01569074|147673323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.239|TWO_SIDED|80.0|0.95|3.44|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||3.44|0.95|0.239
74060364|NCT01569074|147673324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.169|TWO_SIDED|80.0|1.06|4.67||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ration \>1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.67|1.06|0.169
74060365|NCT01569074|147673324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.833|TWO_SIDED|80.0|0.45|1.78||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.78|0.45|0.833
74060366|NCT01569074|147673324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.614|TWO_SIDED|80.0|0.37|1.54||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.54|0.37|0.614
74060367|NCT01569074|147673324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.748|TWO_SIDED|80.0|0.42|1.69||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.69|0.42|0.748
74060368|NCT01569074|147673325|SUPERIORITY_OR_OTHER||Treatment difference|3.01||||0.087|TWO_SIDED|80.0|0.76|5.26|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.26|0.76|0.087
74060369|NCT01569074|147673325|SUPERIORITY_OR_OTHER||Treatment difference|0.25||||0.881|TWO_SIDED|80.0|-1.91|2.41|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||2.41|-1.91|0.881
74060370|NCT01569074|147673325|SUPERIORITY_OR_OTHER||Treatment difference|-0.42||||0.806|TWO_SIDED|80.0|-2.64|1.8|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.80|-2.64|0.806
74060371|NCT01569074|147673325|SUPERIORITY_OR_OTHER||Treatment difference|1.03||||0.548|TWO_SIDED|80.0|-1.17|3.23|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||3.23|-1.17|0.548
74060372|NCT01569074|147673326|SUPERIORITY_OR_OTHER||Treatment difference|3.12||||0.139|TWO_SIDED|80.0|0.42|5.82|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.82|0.42|0.139
74102189|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2634|TWO_SIDED|95.0|-0.12|0.43|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.12|0.2634
73881985|NCT00988884|147297922|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11||1.07|0.87|<0.001
73881986|NCT00988884|147297922|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.98|||<|0.001|TWO_SIDED|95.0|0.89|1.09|||ANOVA|||Anti-HPV 16||1.09|0.89|<0.001
74060373|NCT01569074|147673326|SUPERIORITY_OR_OTHER||Treatment difference|2.47||||0.223|TWO_SIDED|80.0|-0.13|5.07|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.07|-0.13|0.223
74060374|NCT01569074|147673326|SUPERIORITY_OR_OTHER||Treatment difference|-1.63||||0.432|TWO_SIDED|80.0|-4.3|1.04|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.04|-4.30|0.432
74102190|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.133||0.9284|TWO_SIDED|95.0|-0.25|0.28|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.25|0.9284
74102191|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.129||0.9459|TWO_SIDED|95.0|-0.25|0.26|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.25|0.9459
74102192|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.151||0.2908|TWO_SIDED|95.0|-0.46|0.14|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.46|0.2908
74102193|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.146||0.6834|TWO_SIDED|95.0|-0.23|0.35|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.23|0.6834
74102194|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.142||0.3579|TWO_SIDED|95.0|-0.41|0.15|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.41|0.3579
74102195|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.138||0.827|TWO_SIDED|95.0|-0.3|0.24|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.30|0.8270
74102196|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.5292|TWO_SIDED|95.0|-0.34|0.18|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.34|0.5292
74102197|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.127||0.879|TWO_SIDED|95.0|-0.23|0.27|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.23|0.8790
74102198|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.133||0.1347|TWO_SIDED|95.0|-0.46|0.06|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.46|0.1347
74102199|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.129||0.2874|TWO_SIDED|95.0|-0.4|0.12|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.40|0.2874
74102200|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.132||0.0086|TWO_SIDED|95.0|-0.61|-0.09|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.61|0.0086
74102201|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.129||0.7864|TWO_SIDED|95.0|-0.29|0.22|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.29|0.7864
74102202|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.172||0.4383|TWO_SIDED|95.0|-0.48|0.21|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.48|0.4383
74102203|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.167||0.8767|TWO_SIDED|95.0|-0.36|0.31|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.36|0.8767
74102204|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.153||0.0341|TWO_SIDED|95.0|-0.63|-0.03|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.63|0.0341
74102205|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.147||0.5629|TWO_SIDED|95.0|-0.38|0.21|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.38|0.5629
74102206|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.129||0.0016|TWO_SIDED|95.0|-0.67|-0.16|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.16|-0.67|0.0016
74102207|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.126||0.0495|TWO_SIDED|95.0|-0.5|0.0|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.50|0.0495
74102208|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.155||0.7177|TWO_SIDED|95.0|-0.36|0.25|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.36|0.7177
74060375|NCT01569074|147673326|SUPERIORITY_OR_OTHER||Treatment difference|1.45||||0.481|TWO_SIDED|80.0|-1.19|4.09|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.09|-1.19|0.481
74060376|NCT02723786|147673348|OTHER||||||||||||||||||The proportion of participants with DGF was 0.57, highest Posterior Density (HPD) 95% Credible interval (CI) (0.25,0.90). The posterior probability for the proportion of participants with DGF \<30% was 0.07 (HPD 95% CI \[0.00,1.00\]). The posterior probability for the proportion of participants with DGF \<50% was 0.34 (HPD 95% CI \[0.00,1.00\]).|||
74060377|NCT02701049|147673369|OTHER|Among 109,994 patients who entered the ED during Mode 1, 19,742 had SOGI collected (18%). Among 88,143 patients who entered the ED during Mode 2, 3,630 had SOGI collected (4%).||||||||||||||||Historical controls included all patients entering participating EDs as identified by the Electronic Health Record.|Results were compared to historical control population from an electronic health record database, no other data were collected for these participants.|||
74060378|NCT02964910|147673390|NON_INFERIORITY|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95% CI of the seroconversion rate difference was not less than -10%.|the seroconversion rate difference(%)|-2.08|||||TWO_SIDED|95.0|-5.23|0.22||||||||0.22|-5.23|
74102209|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.151||0.9401|TWO_SIDED|95.0|-0.29|0.31|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.29|0.9401
74102210|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.147||0.3201|TWO_SIDED|95.0|-0.44|0.15|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.44|0.3201
74102211|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.144||0.8286|TWO_SIDED|95.0|-0.25|0.32|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.25|0.8286
74102212|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.162||0.3022|TWO_SIDED|95.0|-0.49|0.15|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.49|0.3022
74102213|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.158||0.8022|TWO_SIDED|95.0|-0.35|0.27|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.35|0.8022
74102214|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.165||0.5665|TWO_SIDED|95.0|-0.42|0.23|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.42|0.5665
74102215|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.161||0.817|TWO_SIDED|95.0|-0.36|0.28|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.36|0.8170
74102216|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.155||0.0404|TWO_SIDED|95.0|-0.63|-0.01|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.63|0.0404
74102217|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.151||0.3128|TWO_SIDED|95.0|-0.45|0.15|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.45|0.3128
74060379|NCT02964910|147673391|NON_INFERIORITY|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95%CI of the GMC ratio was not lower than 0.5.|GMC ratio|0.69|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
74102218|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.162||0.24|TWO_SIDED|95.0|-0.51|0.13|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.51|0.2400
74102219|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.157||0.484|TWO_SIDED|95.0|-0.42|0.2|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.42|0.4840
74102220|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.141||0.7768|TWO_SIDED|95.0|-0.32|0.24|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.32|0.7768
74102221|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.137||0.7713|TWO_SIDED|95.0|-0.31|0.23|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.31|0.7713
74102222|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.151||0.0716|TWO_SIDED|95.0|-0.58|0.02|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.58|0.0716
74102223|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.148||0.4317|TWO_SIDED|95.0|-0.41|0.18|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.41|0.4317
74102224|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.162||0.2115|TWO_SIDED|95.0|-0.52|0.12|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.52|0.2115
74102225|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.158||0.2818|TWO_SIDED|95.0|-0.48|0.14|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.48|0.2818
74102226|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.14||0.2018|TWO_SIDED|95.0|-0.46|0.1|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.46|0.2018
74102227|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.137||0.6554|TWO_SIDED|95.0|-0.33|0.21|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.33|0.6554
74102228|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.168||0.4754|TWO_SIDED|95.0|-0.21|0.46|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.21|0.4754
74102229|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.163||0.7776|TWO_SIDED|95.0|-0.28|0.37|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.28|0.7776
74102230|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.213||0.7172|TWO_SIDED|95.0|-0.5|0.35|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.50|0.7172
73881987|NCT00988884|147297922|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.88|1.12|||ANOVA|||Anti-HPV 18||1.12|0.88|<0.001
73881988|NCT00988884|147297922|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|1.04|||<|0.001|TWO_SIDED|95.0|0.93|1.17|||ANOVA|||Anti-HPV 31||1.17|0.93|<0.001
74060380|NCT02964910|147673395|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.778|||||||Chi-squared|||||||0.778
74102231|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.203||0.4791|TWO_SIDED|95.0|-0.55|0.26|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.55|0.4791
74102232|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.164||0.3562|TWO_SIDED|95.0|-0.48|0.17|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.48|0.3562
74060381|NCT02964910|147673396|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.728|||||||Chi-squared|||||||0.728
74060382|NCT02964910|147673397|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.949|||||||Chi-squared|||||||0.949
74060383|NCT02964910|147673398|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.614|||||||Chi-squared|||||||0.614
74060384|NCT02964910|147673399|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.956|||||||Chi-squared|||||||0.956
74060385|NCT00318409|147673405|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.98
74060386|NCT00742859|147673408|OTHER||Hazard Ratio (HR)|0.14||||0.035|TWO_SIDED|95.0|0.017|1.14|||Log Rank|||Betrixaban 40mg compared to Warfarin||1.14|0.017|0.035
74060387|NCT00742859|147673408|OTHER||Hazard Ratio (HR)|0.711||||0.546|TWO_SIDED|95.0|0.225|2.24|||Log Rank|||Betrixaban 60mg compared to Warfarin||2.24|0.225|0.546
74060388|NCT00742859|147673408|OTHER||Hazard Ratio (HR)|0.755||||0.712|TWO_SIDED|95.0|0.239|2.39|||Log Rank|||Betrixaban 80mg compared to Warfarin||2.39|0.239|0.712
74060389|NCT00742859|147673409|OTHER||Hazard Ratio (HR)|0.508||||0.011|TWO_SIDED|95.0|0.301|0.856|||Log Rank|||Betrixaban 40mg compared to Warfarin||0.856|0.301|0.011
73881989|NCT00988884|147297922|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.11|||ANOVA|||Anti-HPV 33||1.11|0.89|<0.001
74060390|NCT00742859|147673409|OTHER||Hazard Ratio (HR)|0.767||||0.308|TWO_SIDED|95.0|0.481|1.22|||Log Rank|||Betrixaban 60mg compared to Warfarin||1.22|0.481|0.308
74060391|NCT00742859|147673409|OTHER||Hazard Ratio (HR)|0.551||||0.022|TWO_SIDED|95.0|0.332|0.914|||Log Rank|||Betrixaban 80mg compared to Warfarin||0.914|0.332|0.022
74060392|NCT00956709|147673413|SUPERIORITY_OR_OTHER|||||||0.56||||||Two patients in each group had incomplete block before sugery.|Wilcoxon (Mann-Whitney)|||||||0.56
73881990|NCT00988884|147297922|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|1.1|||<|0.001|TWO_SIDED|95.0|0.97|1.25|||ANOVA|||Anti-HPV 45||1.25|0.97|<0.001
74060393|NCT00956709|147673415|SUPERIORITY_OR_OTHER|||||||0.3354|||||||Wilcoxon (Mann-Whitney)|||||||0.3354
74060394|NCT00956709|147673416|SUPERIORITY_OR_OTHER|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||||||0.0445
74060395|NCT00962013|147673417|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin is 7%||||||0.0136|||||||Exact Binomial|||This revision study will demonstrate a 5-year survivorship of the Restoration Modular system not seven percent worse than an expected 95% survival rate using a lower 95% one-sided confidence bound.||||0.0136
74060396|NCT00962013|147673419|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from HHS pre-op to HHS 5 year||||<0.0001
74060397|NCT00962013|147673420|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from SF-36 Role-Physical pre-op score to 2 and 5 year scores||||<0.0001
74060398|NCT00962013|147673422|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Exact Binomial|||Post-surgery femoral stem crack/fracture rate compared to 21% (pre-specified in protocol based on literature rates) Femoral subsidence rate compared to 18% (pre-specified in protocol based on literature rates)||||<0.0001
74060399|NCT03706209|147673432|SUPERIORITY||Odds Ratio (OR)|4.12||||0.161|TWO_SIDED|95.0|0.47|35.97|||Cochran-Mantel-Haenszel|||||35.97|0.47|0.161
74060400|NCT03706209|147673432|SUPERIORITY||Odds Ratio (OR)|5.52||||0.111|TWO_SIDED|95.0|0.55|55.43|||Cochran-Mantel-Haenszel|||||55.43|0.55|0.111
74060401|NCT03706209|147673433|SUPERIORITY||Odds Ratio (OR)|1.73||||0.222|TWO_SIDED|95.0|0.71|4.25|||Cochran-Mantel-Haenszel|||||4.25|0.71|0.222
74060402|NCT03706209|147673433|SUPERIORITY||Odds Ratio (OR)|1.91||||0.182|TWO_SIDED|95.0|0.75|4.91|||Cochran-Mantel-Haenszel|||||4.91|0.75|0.182
74060403|NCT03706209|147673434|SUPERIORITY||Odds Ratio (OR)|2.91||||0.294|TWO_SIDED|95.0|0.33|25.39|||Cochran-Mantel-Haenszel|||||25.39|0.33|0.294
74060404|NCT03706209|147673434|SUPERIORITY||Odds Ratio (OR)|4.06||||0.291|TWO_SIDED|95.0|0.31|53.14|||Cochran-Mantel-Haenszel|||||53.14|0.31|0.291
74060405|NCT03706209|147673435|SUPERIORITY||Odds Ratio (OR)|1.31||||0.617|TWO_SIDED|95.0|0.45|3.77|||Cochran-Mantel-Haenszel|||||3.77|0.45|0.617
74060406|NCT03706209|147673435|SUPERIORITY||Odds Ratio (OR)|1.73||||0.319|TWO_SIDED|95.0|0.6|5.0|||Cochran-Mantel-Haenszel|||||5|0.6|0.319
73881991|NCT00988884|147297922|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.98|||<|0.001|TWO_SIDED|95.0|0.88|1.1|||ANOVA|||Anti-HPV 52||1.10|0.88|<0.001
74102233|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.162||0.8859|TWO_SIDED|95.0|-0.3|0.34|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.30|0.8859
74102234|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.192||0.5888|TWO_SIDED|95.0|-0.49|0.28|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.49|0.5888
74102235|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.187||0.3992|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3992
74102236|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.227||0.1212|TWO_SIDED|95.0|-0.8|0.1|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.80|0.1212
74102237|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.221||0.3185|TWO_SIDED|95.0|-0.66|0.22|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.66|0.3185
74102238|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.231||0.4809|TWO_SIDED|95.0|-0.62|0.29|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.62|0.4809
74102239|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.225||0.8953|TWO_SIDED|95.0|-0.42|0.48|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.48|-0.42|0.8953
74102240|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.223||0.5616|TWO_SIDED|95.0|-0.57|0.31|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.57|0.5616
74102241|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.216||0.8571|TWO_SIDED|95.0|-0.39|0.47|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.39|0.8571
73881992|NCT00988884|147297922|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.88|1.1|||ANOVA|||Anti-HPV 58||1.10|0.88|<0.001
74102242|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.213||0.0037|TWO_SIDED|95.0|-1.05|-0.21|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.21|-1.05|0.0037
74102243|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.206||0.0386|TWO_SIDED|95.0|-0.84|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.84|0.0386
73881993|NCT00988884|147297923|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|3.8|||<|0.001|TWO_SIDED|97.5|-1.7|9.3|||Miettinen and Nurminen|||Serogroup A||9.3|-1.7|<0.001
74060407|NCT03706209|147673436|SUPERIORITY||Odds Ratio (OR)|1.5||||0.47|TWO_SIDED|95.0|0.5|4.52|||Cochran-Mantel-Haenszel|||||4.52|0.5|0.47
74060408|NCT03706209|147673436|SUPERIORITY||Odds Ratio (OR)|2.44||||0.136|TWO_SIDED|95.0|0.76|7.82|||Cochran-Mantel-Haenszel|||||7.82|0.76|0.136
74060409|NCT03706209|147673437|SUPERIORITY||least square means|0.2|STANDARD_ERROR_OF_MEAN|1.4||0.894|TWO_SIDED|95.0|-2.6|3.0|||ANCOVA|||||3|-2.6|0.894
74060410|NCT03706209|147673437|SUPERIORITY||least square means|-1.1|STANDARD_ERROR_OF_MEAN|1.4||0.456|TWO_SIDED|95.0|-3.8|1.7|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||1.7|-3.8|0.456
74060411|NCT03706209|147673439|SUPERIORITY|||||||0.572|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.||||||0.572
74060412|NCT03706209|147673439|SUPERIORITY|||||||0.4494|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.||||||0.4494
74060413|NCT03706209|147673440|SUPERIORITY|||||||0.7922|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.||||||0.7922
74060414|NCT03706209|147673440|SUPERIORITY|||||||0.1425|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.||||||0.1425
74060415|NCT03706209|147673441|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.992|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.992
74060416|NCT03706209|147673441|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.143|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.143
74060417|NCT03706209|147673444|SUPERIORITY|||||||0.178|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.178
74060418|NCT03706209|147673444|SUPERIORITY||Odds Ratio (OR)|0.63||||0.718|TWO_SIDED|95.0|0.05|7.48|||Cochran-Mantel-Haenszel|||||7.48|0.05|0.718
74060419|NCT03706209|147673445|SUPERIORITY||Odds Ratio (OR)|2.4||||0.474|TWO_SIDED|95.0|0.21|28.05|||Cochran-Mantel-Haenszel|||||28.05|0.21|0.474
74060420|NCT03706209|147673445|SUPERIORITY||Odds Ratio (OR)|1.25||||0.867|TWO_SIDED|95.0|0.08|19.05|||Cochran-Mantel-Haenszel|||||19.05|0.08|0.867
74060421|NCT03706209|147673446|SUPERIORITY||Odds Ratio (OR)|2.2||||0.375|TWO_SIDED|95.0|0.38|12.84|||Cochran-Mantel-Haenszel|||||12.84|0.38|0.375
74060422|NCT03706209|147673446|SUPERIORITY||Odds Ratio (OR)|4.24||||0.116|TWO_SIDED|95.0|0.66|27.08|||Cochran-Mantel-Haenszel|||||27.08|0.66|0.116
74060423|NCT03706209|147673447|SUPERIORITY||Odds Ratio (OR)|0.41||||0.287|TWO_SIDED|95.0|0.08|2.27|||Cochran-Mantel-Haenszel|||||2.27|0.08|0.287
74060424|NCT03706209|147673447|SUPERIORITY||Odds Ratio (OR)|1.85||||0.332|TWO_SIDED|95.0|0.53|6.4|||Cochran-Mantel-Haenszel|||||6.4|0.53|0.332
74060425|NCT03706209|147673448|SUPERIORITY||Odds Ratio (OR)|0.81||||0.719|TWO_SIDED|95.0|0.25|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.25|0.719
74060426|NCT03706209|147673448|SUPERIORITY||Odds Ratio (OR)|1.72||||0.357|TWO_SIDED|95.0|0.55|5.32|||Cochran-Mantel-Haenszel|||||5.32|0.55|0.357
74060427|NCT03706209|147673449|SUPERIORITY||Odds Ratio (OR)|1.75||||0.355|TWO_SIDED|95.0|0.53|5.72|||Cochran-Mantel-Haenszel|||||5.72|0.53|0.355
74060428|NCT03706209|147673449|SUPERIORITY||Odds Ratio (OR)|2.22||||0.198|TWO_SIDED|95.0|0.67|7.37|||Cochran-Mantel-Haenszel|||||7.37|0.67|0.198
74060429|NCT03706209|147673450|SUPERIORITY||least square means|0.3|STANDARD_ERROR_OF_MEAN|1.0||0.757|TWO_SIDED|95.0|-1.7|2.3|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||2.3|-1.7|0.757
74060430|NCT03706209|147673450|SUPERIORITY||least square means|-1.1|STANDARD_ERROR_OF_MEAN|1.0||0.267|TWO_SIDED|95.0|-3.1|0.9|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||0.9|-3.1|0.267
74060431|NCT03706209|147673451|SUPERIORITY||least square means|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.412|TWO_SIDED|95.0|-1.4|3.4|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.4|-1.4|0.412
74060432|NCT03706209|147673451|SUPERIORITY||least square means|-1.0|STANDARD_ERROR_OF_MEAN|1.2||0.401|TWO_SIDED|95.0|-3.5|1.4|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||1.4|-3.5|0.401
74060433|NCT03706209|147673452|SUPERIORITY||least square means|0.4|STANDARD_ERROR_OF_MEAN|1.7||0.801|TWO_SIDED|95.0|-3.0|3.9|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.9|-3|0.801
74060434|NCT03706209|147673452|SUPERIORITY||least square means|0.1|STANDARD_ERROR_OF_MEAN|1.7||0.957|TWO_SIDED|95.0|-3.4|3.3|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.3|-3.4|0.957
74060435|NCT03706209|147673456|SUPERIORITY||Odds Ratio (OR)|1.45||||0.45|TWO_SIDED|95.0|0.55|3.8|||Cochran-Mantel-Haenszel|||||3.8|0.55|0.45
74060436|NCT03706209|147673456|SUPERIORITY||Odds Ratio (OR)|1.97||||0.186|TWO_SIDED|95.0|0.74|5.26|||Cochran-Mantel-Haenszel|||||5.26|0.74|0.186
74060437|NCT03706209|147673457|SUPERIORITY||Odds Ratio (OR)|0.94||||0.884|TWO_SIDED|95.0|0.41|2.18|||Cochran-Mantel-Haenszel|||||2.18|0.41|0.884
74060438|NCT03706209|147673457|SUPERIORITY||Odds Ratio (OR)|1.49||||0.384|TWO_SIDED|95.0|0.61|3.64|||Cochran-Mantel-Haenszel|||||3.64|0.61|0.384
74060439|NCT03706209|147673458|SUPERIORITY||Odds Ratio (OR)|1.64||||0.311|TWO_SIDED|95.0|0.63|4.26|||Cochran-Mantel-Haenszel|||||4.26|0.63|0.311
74060440|NCT03706209|147673458|SUPERIORITY||Odds Ratio (OR)|1.21||||0.699|TWO_SIDED|95.0|0.47|3.17|||Cochran-Mantel-Haenszel|||||3.17|0.47|0.699
74060441|NCT03706209|147673459|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.671|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.671
74060442|NCT03706209|147673459|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.183|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.183
74060443|NCT03706209|147673460|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.542|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.542
74060444|NCT03706209|147673460|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.328|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.328
74060445|NCT03706209|147673461|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.921|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.921
74060446|NCT03706209|147673461|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.488|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.488
74060447|NCT03706209|147673472|SUPERIORITY|||||||0.1193|||||||Fisher Exact|||||||0.1193
74060448|NCT03706209|147673472|SUPERIORITY|||||||0.0054|||||||Fisher Exact|||||||0.0054
74060449|NCT03706209|147673473|SUPERIORITY|||||||0.2439|||||||Fisher Exact|||||||0.2439
74060450|NCT03706209|147673473|SUPERIORITY|||||||0.2461|||||||Fisher Exact|||||||0.2461
74060451|NCT03706209|147673474|SUPERIORITY|||||||0.4395|||||||Fisher Exact|||||||0.4395
74060452|NCT03706209|147673474|SUPERIORITY|||||||0.0593|||||||Fisher Exact|||||||0.0593
74060453|NCT03706209|147673476|SUPERIORITY|||||||0.0507|||||||Fisher Exact|||||||0.0507
74060454|NCT03706209|147673476|SUPERIORITY|||||||0.0005|||||||Fisher Exact|||||||0.0005
74060455|NCT03706209|147673477|SUPERIORITY|||||||0.0504|||||||Fisher Exact|||||||0.0504
74102244|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.216||0.0044|TWO_SIDED|95.0|-1.05|-0.2|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-1.05|0.0044
74060456|NCT03706209|147673477|SUPERIORITY|||||||0.0013|||||||Fisher Exact|||||||0.0013
74060457|NCT03706209|147673478|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
74060458|NCT03706209|147673478|SUPERIORITY|||||||0.0032|||||||Fisher Exact|||||||0.0032
74060459|NCT01984229|147673490|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|118.0|||||TWO_SIDED|90.0|102.0|137.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals (CIs).||137|102|
74060460|NCT01984229|147673491|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|177.0|||||TWO_SIDED|90.0|159.0|198.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||198|159|
74060461|NCT01984229|147673492|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|175.0|||||TWO_SIDED|90.0|157.0|195.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||195|157|
74060462|NCT01984229|147673496|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|28.7|||||TWO_SIDED|90.0|23.1|35.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||35.5|23.1|
74060463|NCT01984229|147673497|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|66.2|||||TWO_SIDED|90.0|56.7|77.4|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||77.4|56.7|
74060464|NCT01984229|147673498|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|75.1|||||TWO_SIDED|90.0|64.4|87.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||87.7|64.4|
74060465|NCT01275170|147673538|OTHER|Geometric mean ratio (GMR) \[Renal Impairment/Healthy Control\]|GMR|1.63|||||TWO_SIDED|90.0|1.12|2.39||||||||2.39|1.12|
74060466|NCT01275170|147673538|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.19|||||TWO_SIDED|90.0|1.51|3.18||||||||3.18|1.51|
74060467|NCT01275170|147673538|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|4.87|||||TWO_SIDED|90.0|3.37|7.04||||||||7.04|3.37|
74060468|NCT01275170|147673538|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|9.32|||||TWO_SIDED|90.0|6.45|13.46||||||||13.46|6.45|
74060469|NCT01275170|147673538|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.76|||||TWO_SIDED|90.0|1.2|2.58||||||||2.58|1.20|
74060470|NCT01275170|147673539|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.1|||||TWO_SIDED|90.0|0.64|1.88||||||||1.88|0.64|
74060471|NCT01275170|147673539|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.04|||||TWO_SIDED|90.0|0.62|1.77||||||||1.77|0.62|
74060472|NCT01275170|147673539|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.3|||||TWO_SIDED|90.0|0.77|2.2||||||||2.20|0.77|
74060473|NCT01275170|147673539|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.34|||||TWO_SIDED|90.0|1.39|3.96||||||||3.96|1.39|
74060474|NCT01275170|147673539|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.85|||||TWO_SIDED|90.0|0.5|1.44||||||||1.44|0.50|
74060475|NCT01275170|147673540|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||TWO_SIDED|90.0|0.42|0.9||||||||0.90|0.42|
74060476|NCT01275170|147673540|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.46|||||TWO_SIDED|90.0|0.31|0.66||||||||0.66|0.31|
74060477|NCT01275170|147673540|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.21|||||TWO_SIDED|90.0|0.14|0.3||||||||0.30|0.14|
74060478|NCT01275170|147673540|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.11|||||TWO_SIDED|90.0|0.07|0.16||||||||0.16|0.07|
74060479|NCT01275170|147673540|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.57|||||TWO_SIDED|90.0|0.39|0.84||||||||0.84|0.39|
74060480|NCT01275170|147673541|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||TWO_SIDED|90.0|0.82|1.21||||||||1.21|0.82|
74060481|NCT01275170|147673541|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||TWO_SIDED|90.0|0.84|1.22||||||||1.22|0.84|
73881994|NCT00988884|147297923|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|TWO_SIDED|97.5|-5.4|1.1|||Miettinen and Nurminen|||Serogroup C||1.1|-5.4|<0.001
74060482|NCT01275170|147673541|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.9|||||TWO_SIDED|90.0|0.74|1.08||||||||1.08|0.74|
74060483|NCT01275170|147673541|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.96|||||TWO_SIDED|90.0|0.79|1.16||||||||1.16|0.79|
74060484|NCT01275170|147673541|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.28|||||TWO_SIDED|90.0|2.7|4.0||||||||4.00|2.70|
74060485|NCT01275170|147673544|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.41|||||TWO_SIDED|90.0|1.07|1.84||||||||1.84|1.07|
74060486|NCT01275170|147673544|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.53|||||TWO_SIDED|90.0|1.17|1.99||||||||1.99|1.17|
74060487|NCT01275170|147673544|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.51|||||TWO_SIDED|90.0|1.93|3.26||||||||3.26|1.93|
74060488|NCT01275170|147673544|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.1|||||TWO_SIDED|90.0|2.39|4.03||||||||4.03|2.39|
74060489|NCT01275170|147673544|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||TWO_SIDED|90.0|0.76|1.29||||||||1.29|0.76|
74060490|NCT01275170|147673545|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.15|||||TWO_SIDED|90.0|0.65|2.06||||||||2.06|0.65|
74060491|NCT01275170|147673545|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||TWO_SIDED|90.0|0.61|1.89||||||||1.89|0.61|
74060492|NCT01275170|147673545|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.32|||||TWO_SIDED|90.0|0.75|2.32||||||||2.32|0.75|
74060493|NCT01275170|147673545|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.46|||||TWO_SIDED|90.0|1.4|4.33||||||||4.33|1.40|
74060494|NCT01275170|147673545|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.86|||||TWO_SIDED|90.0|0.49|1.51||||||||1.51|0.49|
73881995|NCT00988884|147297923|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|2.1|||<|0.001|TWO_SIDED|97.5|-1.8|6.1|||Miettinen and Nurminen|||Serogroup Y||6.1|-1.8|<0.001
74060495|NCT01275170|147673546|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.71|||||TWO_SIDED|90.0|0.54|0.93||||||||0.93|0.54|
74060496|NCT01275170|147673546|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.65|||||TWO_SIDED|90.0|0.5|0.85||||||||0.85|0.50|
74060497|NCT01275170|147673546|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.4|||||TWO_SIDED|90.0|0.31|0.52||||||||0.52|0.31|
74060498|NCT01275170|147673546|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.32|||||TWO_SIDED|90.0|0.25|0.42||||||||0.42|0.25|
74060499|NCT01275170|147673546|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||TWO_SIDED|90.0|0.78|1.31||||||||1.31|0.78|
74060500|NCT01275170|147673547|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||TWO_SIDED|90.0|0.61|1.08||||||||1.08|0.61|
74060501|NCT01275170|147673547|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.95|||||TWO_SIDED|90.0|0.72|1.26||||||||1.26|0.72|
74060502|NCT01275170|147673547|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.61|1.06||||||||1.06|0.61|
73888218|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1||||0.3885|TWO_SIDED|95.0|-46.3|118.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||118.5|-46.3|0.3885
74060503|NCT01275170|147673547|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.83|||||TWO_SIDED|90.0|0.63|1.09||||||||1.09|0.63|
74060504|NCT01275170|147673547|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.54|||||TWO_SIDED|90.0|1.93|3.36||||||||3.36|1.93|
74060505|NCT01275170|147673550|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.6|||||TWO_SIDED|90.0|1.03|2.49||||||||2.49|1.03|
74060506|NCT01275170|147673550|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.86|||||TWO_SIDED|90.0|1.21|2.87||||||||2.87|1.21|
74060507|NCT01275170|147673550|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|5.6|||||TWO_SIDED|90.0|3.64|8.59||||||||8.59|3.64|
74060508|NCT01275170|147673550|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|13.75|||||TWO_SIDED|90.0|8.96|21.12||||||||21.12|8.96|
74060509|NCT01275170|147673550|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.64|||||TWO_SIDED|90.0|2.32|5.69||||||||5.69|2.32|
74060510|NCT01275170|147673551|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.25|||||TWO_SIDED|90.0|0.75|2.08||||||||2.08|0.75|
74060511|NCT01275170|147673551|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.13|||||TWO_SIDED|90.0|0.69|1.87||||||||1.87|0.69|
74060512|NCT01275170|147673551|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.49|||||TWO_SIDED|90.0|0.9|2.44||||||||2.44|0.90|
74060513|NCT01275170|147673551|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.49|||||TWO_SIDED|90.0|1.51|4.09||||||||4.09|1.51|
74060514|NCT01275170|147673551|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.94|||||TWO_SIDED|90.0|0.57|1.54||||||||1.54|0.57|
74060515|NCT01275170|147673552|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||TWO_SIDED|90.0|0.4|0.97||||||||0.97|0.40|
74060516|NCT01275170|147673552|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.54|||||TWO_SIDED|90.0|0.35|0.83||||||||0.83|0.35|
74060517|NCT01275170|147673552|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.18|||||TWO_SIDED|90.0|0.12|0.27||||||||0.27|0.12|
74060518|NCT01275170|147673552|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.07|||||TWO_SIDED|90.0|0.05|0.11||||||||0.11|0.05|
74060519|NCT01275170|147673552|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.27|||||TWO_SIDED|90.0|0.18|0.43||||||||0.43|0.18|
74060520|NCT01275170|147673553|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.62|1.04||||||||1.04|0.62|
74060521|NCT01275170|147673553|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||TWO_SIDED|90.0|0.71|1.17||||||||1.17|0.71|
74060522|NCT01275170|147673553|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.62|1.03||||||||1.03|0.62|
74060523|NCT01275170|147673553|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.76|||||TWO_SIDED|90.0|0.59|0.97||||||||0.97|0.59|
74060524|NCT01275170|147673553|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.81|||||TWO_SIDED|90.0|2.16|3.65||||||||3.65|2.16|
74060525|NCT01275170|147673559|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.52|||||TWO_SIDED|90.0|1.07|2.15||||||||2.15|1.07|
74060526|NCT01275170|147673559|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||TWO_SIDED|90.0|0.45|0.9||||||||0.90|0.45|
74060527|NCT01275170|147673559|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.67|||||TWO_SIDED|90.0|0.47|0.94||||||||0.94|0.47|
73881996|NCT00988884|147297923|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|TWO_SIDED|97.5|-4.7|0.3|||Miettinen and Nurminen|||Serogroup W-135||0.3|-4.7|<0.001
74060528|NCT01275170|147673560|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||TWO_SIDED|90.0|0.63|1.83||||||||1.83|0.63|
74060529|NCT01275170|147673560|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.6|||||TWO_SIDED|90.0|0.35|1.01||||||||1.01|0.35|
74060530|NCT01275170|147673560|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||TWO_SIDED|90.0|0.36|1.04||||||||1.04|0.36|
74060531|NCT01275170|147673561|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.47|||||TWO_SIDED|90.0|0.63|3.4||||||||3.40|0.63|
74060532|NCT01275170|147673561|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||TWO_SIDED|90.0|0.41|2.0||||||||2.00|0.41|
74060533|NCT01275170|147673561|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||TWO_SIDED|90.0|0.37|1.78||||||||1.78|0.37|
74060534|NCT02044094|147673617|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|3.656|STANDARD_ERROR_OF_MEAN|1.85|||TWO_SIDED|95.0|-0.032|7.344|||||Hydromorphone - Placebo|"Week 1~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||7.344|-0.032|
74102245|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.208||0.8308|TWO_SIDED|95.0|-0.46|0.37|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.46|0.8308
74102246|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.215||0.0388|TWO_SIDED|95.0|-0.87|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.87|0.0388
74102247|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.209||0.1622|TWO_SIDED|95.0|-0.71|0.12|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.71|0.1622
74102248|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.204||0.0179|TWO_SIDED|95.0|-0.89|-0.09|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.89|0.0179
74102249|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.198||0.4283|TWO_SIDED|95.0|-0.55|0.24|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.55|0.4283
74102250|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.219||0.1899|TWO_SIDED|95.0|-0.72|0.15|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.72|0.1899
74060535|NCT02044094|147673617|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|6.927|STANDARD_ERROR_OF_MEAN|1.848|||TWO_SIDED|95.0|3.243|10.612|||||Hydromorphone - Placebo|Week 1 Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05.||10.612|3.243|
74060536|NCT02044094|147673617|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|0.586|STANDARD_ERROR_OF_MEAN|1.283|||TWO_SIDED|95.0|-1.977|3.149|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||3.149|-1.977|
74060537|NCT02044094|147673617|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|2.899|STANDARD_ERROR_OF_MEAN|1.285|||TWO_SIDED|95.0|0.333|5.465|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||5.465|0.333|
74060538|NCT02044094|147673617|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|0.863|STANDARD_ERROR_OF_MEAN|1.959|||TWO_SIDED|95.0|-3.053|4.778|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||4.778|-3.053|
74060539|NCT02044094|147673617|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|4.926|STANDARD_ERROR_OF_MEAN|1.956|||TWO_SIDED|95.0|1.016|8.837|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||8.837|1.016|
74102251|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.213||0.8022|TWO_SIDED|95.0|-0.48|0.37|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.48|0.8022
74102252|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.215||0.378|TWO_SIDED|95.0|-0.62|0.24|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.62|0.3780
74102253|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.21||0.811|TWO_SIDED|95.0|-0.47|0.36|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.47|0.8110
74102254|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.272||0.8908|TWO_SIDED|95.0|-0.58|0.5|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.50|-0.58|0.8908
74102255|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.263||0.3596|TWO_SIDED|95.0|-0.28|0.76|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.76|-0.28|0.3596
74102256|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.293||0.7617|TWO_SIDED|95.0|-0.67|0.49|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.49|-0.67|0.7617
74102257|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.281||0.5498|TWO_SIDED|95.0|-0.73|0.39|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.73|0.5498
74060540|NCT02044094|147673617|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|3.316|STANDARD_ERROR_OF_MEAN|2.367|||TWO_SIDED|95.0|-1.425|8.025|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||8.025|-1.425|
74102258|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.235||0.2066|TWO_SIDED|95.0|-0.76|0.17|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.76|0.2066
74102259|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.2321|TWO_SIDED|95.0|-0.73|0.18|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.73|0.2321
74102260|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.191||0.5582|TWO_SIDED|95.0|-0.49|0.27|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.49|0.5582
74102261|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.186||0.2945|TWO_SIDED|95.0|-0.56|0.17|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.56|0.2945
73881997|NCT00988884|147297924|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|97.5|-0.8|0.9|||Miettinen and Nurminen|||Anti-diphtheria titer \>=0.1 IU/mL||0.9|-0.8|<0.001
73881998|NCT00988884|147297924|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|97.5|-1.2|0.7|||Miettinen and Nurminen|||Anti-tetanus titer \>=0.1 IU/mL||0.7|-1.2|<0.001
73881999|NCT00988884|147297925|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.8||||0.003|TWO_SIDED|97.5|0.69|0.92|||ANOVA|||Anti-PT||0.92|0.69|0.003
74060541|NCT02044094|147673617|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|6.677|STANDARD_ERROR_OF_MEAN|2.367|||TWO_SIDED|95.0|1.936|11.418|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||11.418|1.936|
73882000|NCT00988884|147297925|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.91|||<|0.001|TWO_SIDED|97.5|0.83|1.01|||ANOVA|||Anti-FHA||1.01|0.83|<0.001
74060542|NCT03993288|147673639|NON_INFERIORITY|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean value calculated by the least squares method did not exceed the predetermined boundary of non-inferiority of 5 g/L|Mean Difference (Net)|-0.24||||0.0032|TWO_SIDED|95.0|-4.86|4.38|||ANCOVA|||||4.38|-4.86|0.0032
73882001|NCT00988884|147297925|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|97.5|0.84|1.08|||ANOVA|||Anti-PRN||1.08|0.84|<0.001
74060543|NCT00915473|147673645|SUPERIORITY_OR_OTHER|||||||0.98|||||||Chi-squared|||||||0.98
74060544|NCT00915473|147673646|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||Severe Migraine Frequency||||0.52
74060545|NCT00915473|147673646|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||At least Moderate Migraine Frequency||||0.52
74060546|NCT00915473|147673646|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||At Least Mild Migraine Frequency||||0.47
74060547|NCT00915473|147673647|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.90
74060548|NCT00915473|147673648|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||||||0.47
74060549|NCT03443973|147673654|SUPERIORITY||Difference in Adjusted mean|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2998|TWO_SIDED|95.0|-0.55|0.17|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline (BL) + Geographic Region + Disease Stage + AD Medication at BL + Apolipoprotein E, Allele e4 (APOE e4) + Baseline ADAS COG13 + Baseline Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).||0.17|-0.55|0.2998
74060550|NCT03443973|147673660|SUPERIORITY||Difference in adjusted mean|-1.28|STANDARD_ERROR_OF_MEAN|0.58||0.0273|TWO_SIDED|95.0|-2.41|-0.14|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4||-0.14|-2.41|0.0273
74060551|NCT03443973|147673661|SUPERIORITY||Difference in adjusted mean|0.82|STANDARD_ERROR_OF_MEAN|0.78||0.2918|TWO_SIDED|95.0|-0.7|2.34|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Region + Disease Stage + AD Medication at BL + APOE e4||2.34|-0.70|0.2918
74060552|NCT03443973|147673662|SUPERIORITY||Difference in adjusted mean|-0.86|STANDARD_ERROR_OF_MEAN|0.43||0.0438|TWO_SIDED|95.0|-1.7|-0.02|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.02|-1.70|0.0438
74060553|NCT03443973|147673663|SUPERIORITY||Difference in adjusted mean|0.52|STANDARD_ERROR_OF_MEAN|0.27||0.0566|TWO_SIDED|95.0|-0.01|1.06|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline + Geographic Region + Disease Stage + AD Medication at BL + APOE e4.||1.06|-0.01|0.0566
74060554|NCT03443973|147673664|SUPERIORITY||Difference in adjusted mean|-1.19|STANDARD_ERROR_OF_MEAN|0.53||0.026|TWO_SIDED|95.0|-2.24|-0.14|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.14|-2.24|0.0260
74060555|NCT03443973|147673665|SUPERIORITY||Difference in adjusted mean|-0.03|STANDARD_ERROR_OF_MEAN|0.28||0.9086|TWO_SIDED|95.0|-0.59|0.52|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.52|-0.59|0.9086
74060556|NCT03443973|147673666|SUPERIORITY||Difference in adjusted mean|1.41|STANDARD_ERROR_OF_MEAN|0.76||0.0629|TWO_SIDED|95.0|-0.08|2.9|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.90|-0.08|0.0629
74060557|NCT03443973|147673667|SUPERIORITY||Difference in adjusted mean|0.79|STANDARD_ERROR_OF_MEAN|0.66||0.2348|TWO_SIDED|95.0|-0.51|2.09|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.09|-0.51|0.2348
74060558|NCT03443973|147673674|SUPERIORITY||Difference in adjusted means|-56.46|STANDARD_ERROR_OF_MEAN|3.976|<|0.0001|TWO_SIDED|95.0|-64.36|-48.56|||Mixed Model for Repeated Measures|||Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Type of Tracer + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||-48.56|-64.36|<.0001
74060559|NCT03443973|147673675|SUPERIORITY||Difference in adjusted mean|0.01|STANDARD_ERROR_OF_MEAN|0.023||0.7816|TWO_SIDED|95.0|-0.04|0.05|||Mixed Model for Repeated Measures|||Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.04|0.7816
74060560|NCT03443973|147673675|SUPERIORITY||Difference in adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.018||0.6203|TWO_SIDED|95.0|-0.03|0.05|||Mixed Model for Repeated Measures|||Medial Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.03|0.6203
74102262|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.208||0.2684|TWO_SIDED|95.0|-0.64|0.18|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.64|0.2684
73882002|NCT00988884|147297925|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.96|||<|0.001|TWO_SIDED|97.5|0.76|1.21|||ANOVA|||Anti-FIM 2/3||1.21|0.76|<0.001
73882003|NCT00988884|147297928|SUPERIORITY_OR_OTHER||Difference in percentage|-0.4||||0.806|TWO_SIDED|95.0|-3.5|2.7|||Miettinen and Nurminen|||||2.7|-3.5|0.806
73882004|NCT04999839|147297952|SUPERIORITY||Odds Ratio (OR)|3.727|||=|0.052|TWO_SIDED|95.0|0.933|14.885||P-value was calculated using a Cochran-Mantel-Haenszel (CMH) test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the Mantel-Haenszel (MH) method.|||14.885|0.933|=0.052
73882005|NCT04999839|147297952|SUPERIORITY||Odds Ratio (OR)|12.733|||<|0.001|TWO_SIDED|95.0|3.525|45.994||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||45.994|3.525|<0.001
73882006|NCT04999839|147297952|SUPERIORITY||Odds Ratio (OR)|29.014|||<|0.001|TWO_SIDED|95.0|8.526|98.735||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||98.735|8.526|<0.001
73882007|NCT04999839|147297952|SUPERIORITY||Odds Ratio (OR)|40.111|||<|0.001|TWO_SIDED|95.0|10.277|156.548||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||156.548|10.277|<0.001
74060561|NCT03443973|147673675|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.7754|TWO_SIDED|95.0|-0.03|0.03|||Mixed Model for Repeated Measures|||Frontal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.03|-0.03|0.7754
74102263|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.202||0.9396|TWO_SIDED|95.0|-0.42|0.39|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.42|0.9396
74102264|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.195||0.0283|TWO_SIDED|95.0|-0.82|-0.05|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.82|0.0283
73882008|NCT02734693|147297980|SUPERIORITY||Mean Difference (Final Values)|-5.18|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-7.565|-2.802|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol.||-2.802|-7.565|<0.001
73882009|NCT02734693|147297983|SUPERIORITY||Mean Difference (Final Values)|23.67|STANDARD_ERROR_OF_MEAN|7.395||0.002|TWO_SIDED|95.0|8.987|38.346|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol||38.346|8.987|0.002
73882010|NCT02734693|147297983|SUPERIORITY||Mean Difference (Net)|24.05|STANDARD_ERROR_OF_MEAN|7.389||0.002|TWO_SIDED|95.0|9.381|38.714|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol||38.714|9.381|0.002
73882011|NCT02898454|147297996|SUPERIORITY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.03|-0.71|||ANCOVA|||Data was analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with the corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.71|-1.03|<0.0001
73882012|NCT02898454|147297997|SUPERIORITY||LS mean difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.51|||ANCOVA|||Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.51|-2.10|<0.0001
73888219|NCT01746901|147309542|SUPERIORITY_OR_OTHER||LS Mean Difference|29.5||||0.4801|TWO_SIDED|95.0|-52.9|112.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||112.0|-52.9|0.4801
73888220|NCT01746901|147309543|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.5494|TWO_SIDED|95.0|-2.5|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-2.5|0.5494
74060562|NCT03443973|147673675|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.9022|TWO_SIDED|95.0|-0.05|0.05|||Mixed Model for Repeated Measures|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.05|0.9022
74102265|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.189||0.1794|TWO_SIDED|95.0|-0.63|0.12|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.63|0.1794
74102266|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.188||0.1091|TWO_SIDED|95.0|-0.68|0.07|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.68|0.1091
74102267|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.182||0.7921|TWO_SIDED|95.0|-0.41|0.31|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.41|0.7921
74102268|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.166||0.0055|TWO_SIDED|95.0|-0.8|-0.14|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-0.80|0.0055
74102269|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.161||0.03|TWO_SIDED|95.0|-0.67|-0.03|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.67|0.0300
74102270|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.185||0.0118|TWO_SIDED|95.0|-0.84|-0.11|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-0.84|0.0118
74102271|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.178||0.2266|TWO_SIDED|95.0|-0.57|0.14|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.57|0.2266
74102272|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.181||0.0025|TWO_SIDED|95.0|-0.92|-0.2|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-0.92|0.0025
74102273|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.176||0.0555|TWO_SIDED|95.0|-0.69|0.01|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.69|0.0555
74102274|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.176||0.0013|TWO_SIDED|95.0|-0.93|-0.23|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-0.93|0.0013
74102275|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.171||0.0775|TWO_SIDED|95.0|-0.64|0.03|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.64|0.0775
74102276|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.19||0.0006|TWO_SIDED|95.0|-1.05|-0.3|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.30|-1.05|0.0006
74060563|NCT03443973|147673676|SUPERIORITY||Percent Difference in Geometric Mean|-13.2||||0.014|TWO_SIDED|95.0|-22.51|-2.87|||ANCOVA|||||-2.87|-22.51|0.014
74060564|NCT03443973|147673677|SUPERIORITY||Percent Difference in Geometric Mean|-14.4|||<|0.001|TWO_SIDED|95.0|-21.88|-6.21|||ANCOVA|||||-6.21|-21.88|<0.001
74060565|NCT03443973|147673678|SUPERIORITY||Percent Difference in Geometric Mean|-17.8|||<|0.001|TWO_SIDED|95.0|-24.92|-10.11|||ANCOVA|||||-10.11|-24.92|<0.001
74060566|NCT03443973|147673679|SUPERIORITY||Percent Difference in Geometric Mean|-21.0|||<|0.001|TWO_SIDED|95.0|-28.29|-12.97|||ANCOVA|||||-12.97|-28.29|<0.001
74102277|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.185||0.0415|TWO_SIDED|95.0|-0.75|-0.01|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.75|0.0415
74102278|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.193||0.0581|TWO_SIDED|95.0|-0.75|0.01|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.75|0.0581
74102279|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.188||0.6826|TWO_SIDED|95.0|-0.45|0.3|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.45|0.6826
74102280|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.226||0.0912|TWO_SIDED|95.0|-0.83|0.06|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.83|0.0912
74102281|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3988|TWO_SIDED|95.0|-0.62|0.25|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.62|0.3988
74102282|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.231||0.0504|TWO_SIDED|95.0|-0.91|0.0|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.91|0.0504
74102283|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.22||0.6019|TWO_SIDED|95.0|-0.55|0.32|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.55|0.6019
74060567|NCT01777191|147673704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.248|TWO_SIDED||||||Fisher Exact|||||||0.248
74060568|NCT00315328|147673707|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination).||||0.96
74060569|NCT00315328|147673708|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests used to assess treatment group differences in change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among those with anisometropia only.||||0.78
74060570|NCT00315328|147673709|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among patients with strabismus or combined mechanism only.||||0.99
74060571|NCT00315328|147673710|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero||||.04
74060572|NCT00315328|147673710|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero||||0.003
74060573|NCT00315328|147673711|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Social Stigma subscale.||||<0.01
74060574|NCT00315328|147673712|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Compliance subscale.||||<0.01
73888221|NCT01746901|147309543|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.0626|TWO_SIDED|95.0|-0.1|3.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.8|-0.1|0.0626
74060575|NCT00315328|147673713|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Adverse events subscale.||||0.70
74060576|NCT00315328|147673714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||||95.0|-0.03|0.17||||||95% confidence interval constructed on the treatment group difference in proportion with amblyopic eye visual acuity 20/25 or better at 17 weeks.||0.17|-0.03|
74060577|NCT00315328|147673716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||||95.0|-0.02|0.18||||||95% confidence interval constructed on the treatment group difference of the proportion improving 15 or more letters from baseline to 17 weeks.||0.18|-0.02|
74060578|NCT00315328|147673717|NON_INFERIORITY_OR_EQUIVALENCE|Treatment equivalence was to be declared if the ends of the 2 1-sided 95% confidence intervals constructed on the difference between adjusted mean visual acuity scores were completely contained within the designated equivalence interval of +/- 5 letters.|Mean Difference (Net)|1.2||||||95.0|-0.7|3.1|||ANCOVA|||The trial was designed to evaluate whether patching and atropine are equivalent treatments for amblyopia in children 7 to 12 years old. The sample size was computed based on a standard deviation of 17-week visual acuity scores of 10 letters, correlation between outcome and baseline visual acuity scores of 0.30 and 10% loss to follow up.||3.1|-0.7|
74060579|NCT00315328|147673720|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|0.4|2.2|||ANCOVA|||95% confidence interval constructed on the treatment group difference of mean change in fellow eye visual acuity from baseline to 17 weeks, adjusted for baseline fellow eye visual acuity.||2.2|0.4|
74060580|NCT04253756|147673725|NON_INFERIORITY|The margin of non-inferiority (Delta) was 5g/dl|Mean Difference (Final Values)|0.5||||0.87|TWO_SIDED||||||ANOVA|||||||0.87
74060581|NCT04253756|147673726|NON_INFERIORITY|The non-inferiority margin (Delta) was 10 minutes of run time, no other key parameters|Mean Difference (Final Values)|3.2||||0.32|TWO_SIDED||||||ANOVA|||||||0.32
74060582|NCT01339858|147673758|SUPERIORITY|||||||0.32|||||||ANOVA|||||||0.32
74102284|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.222||0.007|TWO_SIDED|95.0|-1.05|-0.17|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-1.05|0.0070
74102285|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3785|TWO_SIDED|95.0|-0.62|0.24|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.62|0.3785
73888222|NCT01746901|147309543|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7216|TWO_SIDED|95.0|-1.6|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-1.6|0.7216
74060583|NCT01598740|147673769|SUPERIORITY_OR_OTHER|||||||0.0662||95.0|||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.||||0.0662
74060584|NCT01598740|147673770|SUPERIORITY_OR_OTHER|||||||0.1899||95.0|||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.||||0.1899
74060585|NCT02780115|147673786|SUPERIORITY||LS Mean Diff|1.96||||0.1663|TWO_SIDED|95.0|-0.83|4.74|||ANCOVA|||||4.74|-0.83|0.1663
74060586|NCT02780115|147673786|SUPERIORITY||LS Mean Diff|4.77||||0.0009|TWO_SIDED|95.0|1.98|7.56|||ANCOVA|||||7.56|1.98|0.0009
74060587|NCT02780115|147673786|SUPERIORITY||LS Mean Diff|4.54||||0.0014|TWO_SIDED|95.0|1.79|7.29|||ANCOVA|||||7.29|1.79|0.0014
74060588|NCT02780115|147673786|SUPERIORITY||LS Mean Diff|4.81||||0.0008|TWO_SIDED|95.0|2.03|7.58|||ANCOVA|||||7.58|2.03|0.0008
74060589|NCT02742818|147673805|OTHER|||||||0.19|||||||Generalized Estimation Equations (GEE)|Model assuming Gaussian distribution and AR-1 correlation structure, considering repeated measures in time.|||Through inference, changes in body temperature and proportional occurrence of hypothermia during surgery were evaluated using general models of estimating equations (GEE, Liang e Zeger, 1986). Binominal and normal distributions were taken into account, respectively, and assumptions for errors normalities were verified using residual plot graphs and fitted values. The significance of other associated factors and probable outcomes were verified, including gender, age, surgery type and total surgery duration, in minutes. Since analyses were longitudinal, AR-1 working correlation matrix was created.|||0.190
74060590|NCT02742818|147673806|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
74060591|NCT02742818|147673807|OTHER|||||||0.529|||||||Chi-squared|||||||0.529
74060592|NCT02742818|147673808|OTHER|||||||0.999|||||||Chi-squared|||||||0.999
74060593|NCT02742818|147673809|OTHER|||||||0.462|||||||Wilcoxon (Mann-Whitney)|||||||0.462
74060594|NCT03972709|147673825|SUPERIORITY||Difference in Adjusted Means|0.29|STANDARD_ERROR_OF_MEAN|0.188||0.1206||95.0|-0.08|0.66|||MMRM|||||0.66|-0.08|0.1206
74060595|NCT03972709|147673825|SUPERIORITY||Difference in Adjusted Means|0.12|STANDARD_ERROR_OF_MEAN|0.231||0.6127||95.0|-0.34|0.57|||MMRM|||||0.57|-0.34|0.6127
74060596|NCT03972709|147673832|SUPERIORITY||Difference in Adjusted Means|-0.39|STANDARD_ERROR_OF_MEAN|1.901||0.8388|TWO_SIDED|95.0|-4.14|3.36|||MMRM|||||3.36|-4.14|0.8388
74060597|NCT03972709|147673832|SUPERIORITY||Difference in Adjusted Means|-0.48|STANDARD_ERROR_OF_MEAN|2.384||0.8412|TWO_SIDED|95.0|-5.18|4.23|||MMRM|||||4.23|-5.18|0.8412
74060598|NCT03972709|147673833|SUPERIORITY||Difference in Adjusted Means|0.83|STANDARD_ERROR_OF_MEAN|2.052||0.6865|TWO_SIDED|95.0|-3.22|4.88|||MMRM|||||4.88|-3.22|0.6865
74060599|NCT03972709|147673833|SUPERIORITY||Difference in Adjusted Means|0.2|STANDARD_ERROR_OF_MEAN|2.5||0.9355||95.0|-4.73|5.13|||MMRM|||||5.13|-4.73|0.9355
74060600|NCT00091507|147673834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.28|TWO_SIDED|95.0|0.66|1.13|||Regression, Logistic|||||1.13|0.66|0.28
74060601|NCT00091507|147673835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.08|TWO_SIDED|95.0|0.3|1.07|||Regression, Logistic|||||1.07|0.30|0.08
74060602|NCT00091507|147673836|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.24|TWO_SIDED|95.0|0.43|1.23|||Regression, Logistic|||||1.23|0.43|0.24
74060603|NCT00091507|147673837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.27|TWO_SIDED|95.0|0.4|1.29|||Regression, Logistic|||||1.29|0.40|0.27
74060604|NCT00091507|147673838|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.01|TWO_SIDED|95.0|0.27|0.85|||Regression, Logistic|||||0.85|0.27|0.01
74060605|NCT00203931|147673841|SUPERIORITY_OR_OTHER|||||||0.11|||||||Log Rank|||||||0.11
74060606|NCT00203931|147673842|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon-Gehan test|||||||0.91
74060607|NCT00203931|147673843|SUPERIORITY_OR_OTHER|||||||0.24|||||||Fisher Exact|||||||0.24
74060608|NCT00203931|147673844|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon-Gehan test|||||||0.046
74060609|NCT00203931|147673845|SUPERIORITY_OR_OTHER|||||||0.029|||||||Log Rank|||||||0.029
74060610|NCT01393626|147673866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86||||0.3249|TWO_SIDED|95.0|-7.64|21.36|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo||21.36|-7.64|0.3249
74060611|NCT01393626|147673866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.36||||0.3916|TWO_SIDED|95.0|-8.09|20.8|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo||20.80|-8.09|0.3916
74060612|NCT02426125|147673886|SUPERIORITY||Hazard Ratio (HR)|0.757||||0.0118|TWO_SIDED|95.0|0.607|0.943||Stratified|Log Rank||Stratified|||0.943|0.607|0.0118
74060613|NCT02426125|147673887|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.2461|TWO_SIDED|95.0|0.724|1.086||Stratified|Log Rank||Stratified|||1.086|0.724|0.2461
74102286|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.159||0.9609|TWO_SIDED|95.0|-0.32|0.31|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.32|0.9609
74060614|NCT02426125|147673890|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.189|TWO_SIDED|95.0|0.473|1.158|||Log Rank|||||1.158|0.473|0.189
74060615|NCT02426125|147673891|SUPERIORITY||Hazard Ratio (HR)|0.879||||0.357|TWO_SIDED|95.0|0.663|1.167||Stratified|Log Rank||Stratified|Global health status/QoL||1.167|0.663|0.357
74060616|NCT03506425|147673913|OTHER|||||||0.32|||||||t-test, 2 sided|||||||0.32
74060617|NCT03506425|147673914|OTHER|||||||0.08|||||||ANOVA|||||||0.08
74060618|NCT03506425|147673915|OTHER|||||||0.83|||||||ANOVA|||||||0.83
74060619|NCT04193033|147673943|SUPERIORITY|||||||0.001|||||||Linear Growth Curve Model|||||||0.001
74060620|NCT04193033|147673944|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
74060621|NCT04193033|147673945|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
74060622|NCT04193033|147673947|SUPERIORITY|||||||0.49|||||||Linear Growth Curve Model|Time was included as a fixed effect and both time and intercept were included as random effects.||||||.49
74060623|NCT04193033|147673949|SUPERIORITY|||||||0.06||||||Paired t-test, alpha = .05.|t-test, 2 sided|||||||0.06
74060624|NCT00118209|147673976|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6519|TWO_SIDED|95.0|0.68|1.27|||Log Rank|||||1.27|0.68|0.6519
74060625|NCT00118209|147673977|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
74060626|NCT00118209|147673978|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6414|TWO_SIDED|95.0|0.75|1.59|||Log Rank|||||1.59|0.75|0.6414
74060627|NCT00090259|147673985|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.899||||0.027|TWO_SIDED|95.0|0.818|0.988|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.988|0.818|0.027
74060628|NCT00090259|147673986|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.924||||0.068|TWO_SIDED|95.0|0.848|1.006|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||1.006|0.848|0.068
74060629|NCT00090259|147673987|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.235|TWO_SIDED|95.0|0.84|1.044|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||1.044|0.840|0.235
74060630|NCT00090259|147673988|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.865||||0.025|TWO_SIDED|95.0|0.762|0.982|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.982|0.762|0.025
74060631|NCT00090259|147673989|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.892||||0.023|TWO_SIDED|95.0|0.808|0.984|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.984|0.808|0.023
74060632|NCT00345969|147673990|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
74060633|NCT00345969|147673991|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||ANOVA|||||||0.55
74060634|NCT00345969|147673992|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||ANOVA|||||||0.23
74060635|NCT00345969|147673993|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||ANOVA|||||||0.43
74060636|NCT00345969|147673994|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||ANOVA|||||||0.33
74060637|NCT00345969|147673995|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||ANOVA|||||||0.93
74060638|NCT00345969|147673996|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||ANOVA|||||||0.24
74060639|NCT00345969|147673997|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||ANOVA|||||||0.49
74060640|NCT00345969|147673998|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||ANOVA|||||||0.19
74060641|NCT00345969|147673999|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||0.71
74060642|NCT00345969|147674000|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||ANOVA|||||||0.44
74060643|NCT00345969|147674001|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||ANOVA|||||||0.89
74060644|NCT00345969|147674002|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANOVA|||||||0.13
74102287|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.154||0.9183|TWO_SIDED|95.0|-0.32|0.29|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.32|0.9183
74102288|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.149||0.071|TWO_SIDED|95.0|-0.57|0.02|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.57|0.0710
74102289|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.143||0.2607|TWO_SIDED|95.0|-0.45|0.12|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.45|0.2607
74102290|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.158||0.2466|TWO_SIDED|95.0|-0.5|0.13|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.50|0.2466
74102291|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.153||0.3461|TWO_SIDED|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.45|0.3461
74102292|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.162||0.0919|TWO_SIDED|95.0|-0.6|0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.60|0.0919
74060645|NCT00981019|147674008|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||"Study was exploratory, thus no hypotheses had been formalized beforehand.~To analyze repeated measures outcomes (e.g., effect of the four different statistic scenarios on doctors' recommendation of screening, their judgment of screening's effectiveness, etc.), we used the McNemar chi-square test and the Wilcoxon signed-rank test.~To test for order effects (scenarios were randomly presented)Pearson's chi-square test and the Mann-Whitney U test were used."||||<0.05
74060646|NCT00285012|147674032|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.4|||<|0.0001||95.0|4.99|14.14||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Primary endpoint was based on a CO confirmed 4-week CQR (weeks 4 through 12 inclusive). Intent was to evaluate the alternative hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment in subjects with mild to moderate COPD.||14.14|4.99|<0.0001
74060647|NCT00285012|147674033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.88|||<|0.0001||95.0|2.75|8.65||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline versus (vs) placebo at Week 24||8.65|2.75|<0.0001
74060648|NCT00285012|147674033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.04|||<|0.0001||95.0|2.13|7.67||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||7.67|2.13|<0.0001
74060649|NCT00285012|147674034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.17|||<|0.0001||95.0|2.96|9.02||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24||9.02|2.96|<0.0001
74060650|NCT00285012|147674034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.0001||95.0|2.18|7.07||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||7.07|2.18|<0.0001
74060651|NCT00285012|147674035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.99|||<|0.0001||95.0|4.39|11.11||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 12||11.11|4.39|<0.0001
74060652|NCT00285012|147674035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001||95.0|1.79|4.54|||Regression, Logistic|p-value obtained from a logistic regression model including the main effects of treatment and pooled center|odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24||4.54|1.79|<0.0001
74060653|NCT00285012|147674035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0008||95.0|1.37|3.48||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||3.48|1.37|0.0008
74060654|NCT00285012|147674036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.0002||95.0|1.52|3.95||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||3.95|1.52|0.0002
74060655|NCT00285012|147674037|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 \[LOCF\] pre-bronchodilator||||0.140
74060656|NCT00285012|147674037|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 \[LOCF\] post-bronchodilator||||0.007
74060657|NCT00285012|147674037|SUPERIORITY_OR_OTHER|||||||0.684||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 \[LOCF\] pre-bronchodilator||||0.684
74060658|NCT00285012|147674037|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 \[LOCF\] post-bronchodilator||||0.901
74060659|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Mental State||||0.078
74060660|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Mental State||||0.109
74060661|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Mental State||||0.281
74060662|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Functional State||||0.581
74060663|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Functional State||||0.290
74060664|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Functional State||||0.063
74060665|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Respiratory Symptoms||||0.002
74060666|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.081||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Respiratory Symptoms||||0.081
74060667|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Respiratory Symptoms||||0.016
74060668|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Total Score||||0.033
74060669|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Total Score||||0.078
74060670|NCT00285012|147674038|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Total Score||||0.023
74060671|NCT02873195|147674072|SUPERIORITY||Hazard Ratio (HR)|0.725||||0.051|TWO_SIDED|95.0|0.491|1.07|||Log Rank|||||1.07|0.491|0.051
74060672|NCT02873195|147674073|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4|TWO_SIDED|95.0|0.56|1.56|||Log Rank|||||1.56|0.56|0.40
74060673|NCT02873195|147674074|SUPERIORITY|||||||0.4876|||||||Fisher Exact|||||||0.4876
74102293|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.157||0.7554|TWO_SIDED|95.0|-0.36|0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.36|0.7554
73888223|NCT01746901|147309543|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.3647|TWO_SIDED|95.0|-1.0|2.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.8|-1.0|0.3647
74060674|NCT05004181|147674090|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the GMR was greater than 0.67.|Geometric mean ratio|13.12|||||TWO_SIDED|95.0|11.14|15.45|||||GMRs and 2-sided 95% CIs were based on the analysis of logarithmically transformed neutralizing titers using a linear regression model with terms of age, sex, and group.|||15.45|11.14|
74060675|NCT05004181|147674091|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the difference of percentages was greater than -10%.|Difference in Percentages|-4.55|||||TWO_SIDED|95.0|-10.04|0.83|||||Adjusted difference in percentages were estimated using minimum risk weights and stratified by sex and age group.|||0.83|-10.04|
74060676|NCT05004181|147674093|OTHER||Difference in Percentages|36.73|||||TWO_SIDED|95.0|19.21|51.17|||||Adjusted difference was estimated using the minimum risk weights and stratified by sex and age group.|||51.17|19.21|
74060677|NCT00752895|147674113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression|||||||0.295
74060678|NCT00752895|147674114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression|||||||0.820
74060679|NCT03353415|147674125|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
74060680|NCT03353415|147674126|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
74060681|NCT03353415|147674127|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
74060682|NCT03353415|147674128|OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
74060683|NCT03353415|147674129|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
74060684|NCT03353415|147674130|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
74060685|NCT03353415|147674131|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
74060686|NCT03353415|147674132|OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
73888224|NCT01746901|147309543|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.4456|TWO_SIDED|95.0|-2.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-2.7|0.4456
74060687|NCT03353415|147674133|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
74060688|NCT03353415|147674134|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
74060689|NCT03353415|147674135|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
74060690|NCT03353415|147674136|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
74060691|NCT03353415|147674137|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
74060692|NCT03353415|147674138|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
74060693|NCT03353415|147674139|OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
74060694|NCT03353415|147674140|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
74060695|NCT03353415|147674141|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
74060696|NCT03353415|147674142|OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
74060697|NCT03353415|147674143|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
74060698|NCT03353415|147674144|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
74060699|NCT03353415|147674145|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
74060700|NCT05257109|147674146|OTHER|Mixed effects models with water concentration as the within subject factor and irritation as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Median Difference (Final Values)|0.67||||0.0014|TWO_SIDED|||||Significant p-value set at \<0.05|Mixed Models Analysis|||||||0.0014
74060701|NCT05257109|147674147|OTHER|Mixed effects models with water concentration as the within subject factor and LHS as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Mean Difference (Final Values)|1.55|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
74060702|NCT05257109|147674148|OTHER|Mixed effects models with water concentration as the within subject factor and DEQ as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Mean Difference (Final Values)|3.28|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
74060703|NCT00584831|147674149|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060704|NCT00584831|147674149|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hyposthesis is that visual acuity is the same for all lens types.||||0.02
74060705|NCT00584831|147674149|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060706|NCT00584831|147674149|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060707|NCT00584831|147674149|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
73882013|NCT02898454|147297998|SUPERIORITY|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 52 SNOT-22.|LS mean difference|-5.13|||<|0.0001|TWO_SIDED|95.0|-5.8|-4.46||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-4.46|-5.80|<0.0001
73882014|NCT02898454|147297999|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.44|||<|0.0001|TWO_SIDED|95.0|-2.87|-2.02||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.02|-2.87|<0.0001
74060708|NCT00584831|147674149|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060709|NCT00584831|147674150|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060710|NCT00584831|147674150|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060711|NCT00584831|147674150|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060712|NCT00584831|147674150|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060713|NCT00584831|147674150|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060714|NCT00584831|147674150|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060715|NCT00584831|147674151|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.13||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060716|NCT00584831|147674151|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060717|NCT00584831|147674151|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060718|NCT00584831|147674151|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060719|NCT00584831|147674151|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060720|NCT00584831|147674151|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060721|NCT00584831|147674152|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060722|NCT00584831|147674152|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060723|NCT00584831|147674152|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060724|NCT00584831|147674152|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060725|NCT00584831|147674152|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060726|NCT00584831|147674152|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
74060727|NCT01371006|147674177|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|105.61|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|90.81|122.82|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz||122.82|90.81|
74060728|NCT01371006|147674178|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|116.12|STANDARD_DEVIATION|18.8|||TWO_SIDED|90.0|101.87|132.35|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz||132.35|101.87|
74102294|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.166||0.015|TWO_SIDED|95.0|-0.74|-0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.74|0.0150
74060729|NCT01371006|147674179|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|71.83|STANDARD_DEVIATION|23.6|||TWO_SIDED|90.0|61.46|83.95|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||83.95|61.46|
74060730|NCT01371006|147674180|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|64.97|STANDARD_DEVIATION|30.2|||TWO_SIDED|90.0|53.32|79.16|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||79.16|53.32|
74060731|NCT01371006|147674181|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|54.31|STANDARD_DEVIATION|44.2|||TWO_SIDED|90.0|40.47|72.88|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||72.88|40.47|
74060732|NCT03515837|147674202|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0122|TWO_SIDED|95.0|0.65|0.97|||Log Rank|One-sided p-value based on log-rank test stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||0.97|0.65|0.0122
74060733|NCT03515837|147674203|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0362|TWO_SIDED|95.0|0.69|1.02|||Log Rank|One-sided p-value based on log-rank test stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||1.02|0.69|0.0362
74060734|NCT03515837|147674204|SUPERIORITY||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-6.0|9.9|||||Based on Miettinen \& Nurminen method stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||9.9|-6.0|
74060735|NCT03515837|147674206|OTHER||Difference in LS Means|1.59|||||TWO_SIDED|95.0|-1.93|5.1|||||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors PD-L1 expression, treatment history, and geographic region of the enrolling site as covariates.|||5.10|-1.93|
74060736|NCT03515837|147674207|OTHER||Hazard Ratio (HR)|0.93||||||95.0|0.68|1.27|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||1.27|0.68|
74060737|NCT04662086|147674257|OTHER|||||||0.2||||||A p-value of \<0.05 would be considered statistically significant.|Linear mixed-effects regression model|||A generalized linear mixed effects model with parameterization was utilized to capture the difference in change in viral shedding at day 10 between treatment arms. SARS-CoV2 viral RNA CT values were transformed using a standard Reference curve.||||0.20
74060738|NCT04662086|147674258|OTHER||Hazard Ratio (HR)|0.6||||0.07|TWO_SIDED|95.0|0.34|1.04||A p-value of \<0.05 would be considered statistically significant.|Cox proportional hazards model|Two-sided Cox proportional hazards model adjusted for age, sex, and receipt of baseline receipt of monoclonal antibodies.||A two-sided log rank test at the 0.04999 level of significance for the final analysis required 78 events (i.e., sustained symptom resolution) to provide 80% power to detect a hazard ratio of 1.91. Based on previous outpatient COVID-19 trials at Stanford, assumed placebo and treatment arm median time to symptom resolution of 10 and 5 days, respectively, for a total sample size of 120 patients. Participants with missing data lasting through Day 28 were censored on Day 28.||1.04|0.34|0.07
74060739|NCT04662086|147674260|OTHER||Hazard Ratio (HR)|0.62||||0.05|TWO_SIDED|95.0|0.38|1.01|||Linear mixed-effects regression model|||||1.01|0.38|0.05
74060740|NCT04662086|147674261|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.34|1.01||||||||1.01|0.34|
74060741|NCT04662086|147674262|OTHER|||||||0.21||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||Difference in incidence of ED visits||||0.21
74102295|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.16||0.0482|TWO_SIDED|95.0|-0.64|0.0|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.64|0.0482
74060742|NCT01856686|147674264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56593|||||||ANCOVA|||Between-Group Comparison||||0.56593
74060743|NCT01856686|147674264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44929|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.44929
74060744|NCT01856686|147674264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81844|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.81844
74060745|NCT01856686|147674265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71152|||||||ANCOVA|||Between-Group Comparison||||0.71152
74060746|NCT01856686|147674265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27795
74060747|NCT01856686|147674265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47616|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.47616
74060748|NCT01856686|147674266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.10036|||||||ANCOVA|||Between-Group Comparison||||0.10036
74060749|NCT01856686|147674266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0082|||||||Paired t-test|||Within-group changes||||0.00820
74060750|NCT01856686|147674266|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||1.00000
74060751|NCT01856686|147674267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92193|||||||ANCOVA|||Between-Group Comparison||||0.92193
74060752|NCT01856686|147674267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.50704|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.50704
74060753|NCT01856686|147674267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42314|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.42314
74060754|NCT01856686|147674268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08946|||||||ANCOVA|||Between-Group Comparison||||0.08946
74060755|NCT01856686|147674268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27795
74060756|NCT01856686|147674268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.01090
74060757|NCT01856686|147674269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73209|||||||ANCOVA|||Between-Group Comparison||||0.73209
74060758|NCT01856686|147674269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07965|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.07965
74060759|NCT01856686|147674269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61613|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.61613
74060760|NCT01856686|147674270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33027|||||||ANCOVA|||Between-Group Comparison||||0.33027
74060761|NCT01856686|147674270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00013|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00013
74060762|NCT01856686|147674270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28019|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.28019
74060763|NCT01856686|147674271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94449|||||||ANCOVA|||Between-Group Comparison||||0.94449
74060764|NCT01856686|147674271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.94574
74060765|NCT01856686|147674271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85428|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.85428
74060766|NCT01856686|147674272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83929|||||||ANCOVA|||Between-Group Comparison||||0.83929
74060767|NCT01856686|147674272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97213|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.97213
74060768|NCT01856686|147674272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58323|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.58323
74060769|NCT01856686|147674273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05158|||||||ANCOVA|||Between-Group Comparison||||0.05158
74060770|NCT01856686|147674273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.94574
74060771|NCT01856686|147674273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09331|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.09331
74060772|NCT01856686|147674274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17383|||||||ANCOVA|||Between-Group Comparison||||0.17383
74060773|NCT01856686|147674274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00092|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00092
74060774|NCT01856686|147674274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15544|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.15544
74060775|NCT01856686|147674275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39707|||||||ANCOVA|||Between-Group Comparison||||0.39707
74060776|NCT01856686|147674275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27945|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27945
74060777|NCT01856686|147674275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.19739
74060778|NCT01856686|147674276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.50964|||||||ANCOVA|||Between-Group Comparison||||0.50964
74060779|NCT01856686|147674276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0071|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00710
74060780|NCT01856686|147674276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00595|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00595
74060781|NCT01856686|147674277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48336|||||||ANCOVA|||Between-Group Comparison||||0.48336
74060782|NCT01856686|147674277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.08739
74060783|NCT01856686|147674277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37046|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.37046
74060784|NCT01856686|147674279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45013|||||||ANCOVA|||Between-Group Comparison||||0.45013
74060785|NCT01856686|147674279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17374|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.17374
74060786|NCT01856686|147674279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07548|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.07548
74060787|NCT01856686|147674280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23226|||||||ANCOVA|||Between-Group Comparison||||0.23226
74060788|NCT01856686|147674280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08812|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.08812
74060789|NCT01856686|147674280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00776|||||||Pairedt-test|||Within-group comparisons between the baseline and 3 month data||||0.00776
74060790|NCT01856686|147674281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.90843|||||||ANCOVA|||Between-Group Comparison||||0.90843
74060791|NCT01856686|147674281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00413|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00413
74060792|NCT01856686|147674281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00775|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00775
74060793|NCT00468312|147674295|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
74060794|NCT00468312|147674296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||0.026
74060795|NCT00468312|147674297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
74060796|NCT00468312|147674298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
74060797|NCT00468312|147674299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.269||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||0.269
74060798|NCT01052038|147674300|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||||||<0.001
74060799|NCT01052038|147674300|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
74060800|NCT01052038|147674300|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
74060801|NCT01052038|147674301|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|Dunn's post hoc-test corrected for 12 comparisons.||||||<0.001
74060802|NCT01052038|147674301|SUPERIORITY_OR_OTHER||Median Difference (Net)|22.0||||0.005|TWO_SIDED|95.0|14.0|29.0|||Wilcoxon (Mann-Whitney)|||||29|14|0.005
74060803|NCT01052038|147674301|SUPERIORITY_OR_OTHER||Median Difference (Net)|14.0||||0.004|TWO_SIDED|95.0|7.0|22.0|||Wilcoxon (Mann-Whitney)|||||22|7|0.004
74060804|NCT01052038|147674302|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared, Corrected|||||||0.004
74060805|NCT01052038|147674303|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Kruskal-Wallis|Post hoc test using Dunn's test corrected for 12 comparisons||||||0.01
74060806|NCT01052038|147674303|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.0||||0.003||95.0|0.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|0|0.003
74060807|NCT01052038|147674304|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared, Corrected|||||||0.04
74060808|NCT03349437|147674306|SUPERIORITY|||||||0.02||||||This p-value is in reference to the total Modified 6MWT Distance|Wilcoxon Signed Rank|||||||0.02
74060809|NCT01461369|147674307|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-11.68|STANDARD_ERROR_OF_MEAN|3.806||0.0024|TWO_SIDED|95.0|-19.17|-4.19|||Mixed Models Analysis|||||-4.19|-19.17|0.0024
74060810|NCT01461369|147674307|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.58|STANDARD_ERROR_OF_MEAN|3.739||0.0795|TWO_SIDED|95.0|-13.94|0.78|||Mixed Models Analysis|||||0.78|-13.94|0.0795
74060811|NCT01461369|147674308|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-15.82|STANDARD_ERROR_OF_MEAN|3.552|<|0.0001|TWO_SIDED|95.0|-22.82|-8.83|||Mixed Models Analysis|||||-8.83|-22.82|<0.0001
74060812|NCT01461369|147674308|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.8|STANDARD_ERROR_OF_MEAN|3.481||0.0052|TWO_SIDED|95.0|-16.66|-2.95|||Mixed Models Analysis|||||-2.95|-16.66|0.0052
74060813|NCT01461369|147674309|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.43|STANDARD_ERROR_OF_MEAN|3.776||0.0011|TWO_SIDED|95.0|-19.87|-4.99|||Mixed Models Analysis|||||-4.99|-19.87|0.0011
74060814|NCT01461369|147674309|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.56|STANDARD_ERROR_OF_MEAN|3.707||0.1349|TWO_SIDED|95.0|-12.86|1.74|||Mixed Models Analysis|||||1.74|-12.86|0.1349
74060815|NCT01461369|147674310|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-13.24|STANDARD_ERROR_OF_MEAN|3.377||0.0001|TWO_SIDED|95.0|-19.89|-6.59|||ANCOVA|||||-6.59|-19.89|0.0001
74060816|NCT01461369|147674310|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.48|STANDARD_ERROR_OF_MEAN|3.313||0.0248|TWO_SIDED|95.0|-14.0|-0.96|||ANCOVA|||||-0.96|-14.00|0.0248
74060817|NCT01461369|147674311|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.63|STANDARD_ERROR_OF_MEAN|3.396||0.0002|TWO_SIDED|95.0|-19.32|-5.94|||ANCOVA|||||-5.94|-19.32|0.0002
74060818|NCT01461369|147674311|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.03|STANDARD_ERROR_OF_MEAN|3.339||0.0363|TWO_SIDED|95.0|-13.6|-0.45|||ANCOVA|||||-0.45|-13.60|0.0363
74060819|NCT01461369|147674312|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.38|STANDARD_ERROR_OF_MEAN|3.441||0.0028|TWO_SIDED|95.0|-17.16|-3.6|||ANCOVA|||||-3.60|-17.16|0.0028
74060820|NCT01461369|147674312|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.46|STANDARD_ERROR_OF_MEAN|3.385||0.1081|TWO_SIDED|95.0|-12.13|1.21|||ANCOVA|||||1.21|-12.13|0.1081
74060821|NCT02367729|147674328|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.3947||0.003|TWO_SIDED|95.0|1.37|2.93|||Wilcoxon (Mann-Whitney)|||||2.93|1.37|0.003
74060822|NCT00759174|147674336|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.033|TWO_SIDED|95.0|1.06|4.34|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||4.34|1.06|0.033
74060823|NCT00759174|147674337|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.36||||0.003|TWO_SIDED|95.0|1.33|4.19|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||4.19|1.33|0.003
74060824|NCT00759174|147674338|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|1.7|7.69|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||7.69|1.70|<0.001
74060825|NCT01890109|147674339|SUPERIORITY||Least Square Geometric Mean Ratio|1.1||||0.723|TWO_SIDED|95.0|0.66|1.83|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the number of daily moderate to severe hot flashes. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline number of daily moderate to severe hot flashes was used as a covariate.||1.83|0.66|0.723
74060826|NCT01890109|147674340|SUPERIORITY||Least Square Geometric Mean Ratio|1.14||||0.551|TWO_SIDED|95.0|0.74|1.74|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the daily hot flash severity score. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline daily hot flash severity score was used as a covariate.||1.74|0.74|0.551
74060827|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|6.116|||<|0.0001|TWO_SIDED|95.0|5.976|6.255|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"||6.255|5.976|<.0001
74060828|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|6.073|||<|0.0001|TWO_SIDED|95.0|5.963|6.183|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"||6.183|5.963|<.0001
74060829|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.736|||<|0.0001|TWO_SIDED|95.0|5.605|5.868|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"||5.868|5.605|<.0001
74060830|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|5.792|||<|0.0001|TWO_SIDED|95.0|5.687|5.897|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"||5.897|5.687|<.0001
74060831|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.835|||<|0.0001|TWO_SIDED|95.0|5.701|5.969|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"||5.969|5.701|<.0001
74060832|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|5.799|||<|0.0001|TWO_SIDED|95.0|5.694|5.904|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"||5.904|5.694|<.0001
74060833|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|4.881|||<|0.0001|TWO_SIDED|95.0|4.713|5.048|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"||5.048|4.713|<.0001
74102296|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.163||0.0003|TWO_SIDED|95.0|-0.93|-0.28|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.28|-0.93|0.0003
74102297|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.156||0.1182|TWO_SIDED|95.0|-0.56|0.06|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.56|0.1182
74060834|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.844|||<|0.0001|TWO_SIDED|95.0|4.711|4.977|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"||4.977|4.711|<.0001
74060835|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.185|||<|0.0001|TWO_SIDED|95.0|5.021|5.35|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"||5.350|5.021|<.0001
74060836|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.933|||<|0.0001|TWO_SIDED|95.0|4.801|5.066|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"||5.066|4.801|<.0001
74060837|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.014|||<|0.0001|TWO_SIDED|95.0|4.852|5.175|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"||5.175|4.852|<.0001
74060838|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.892|||<|0.0001|TWO_SIDED|95.0|4.763|5.02|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"||5.020|4.763|<.0001
74060839|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.379||||0.0013|TWO_SIDED|95.0|-0.646|-0.112|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.112|-0.646|0.0013
74060840|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.281||||0.0034|TWO_SIDED|95.0|-0.496|-0.065|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.065|-0.496|0.0034
74060841|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.281||||0.0354|TWO_SIDED|95.0|-0.549|-0.012|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.012|-0.549|0.0354
74060842|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.274||||0.0044|TWO_SIDED|95.0|-0.489|-0.059|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.059|-0.489|0.0044
74060843|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-1.235|||<|0.0001|TWO_SIDED|95.0|-1.539|-0.93|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.930|-1.539|<.0001
74060844|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-1.229|||<|0.0001|TWO_SIDED|95.0|-1.475|-0.983|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.983|-1.475|<.0001
74060845|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.23|-0.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.630|-1.230|<.0001
74060846|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.383|-0.896|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.896|-1.383|<.0001
74060847|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.723|||<|0.0001|TWO_SIDED|95.0|0.436|1.009|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)"||1.009|0.436|<.0001
74060848|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.901|||<|0.0001|TWO_SIDED|95.0|0.667|1.134|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)"||1.134|0.667|<.0001
74060849|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.821|||<|0.0001|TWO_SIDED|95.0|0.533|1.109|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)"||1.109|0.533|<.0001
74060850|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.907|||<|0.0001|TWO_SIDED|95.0|0.675|1.14|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)"||1.140|.675|<.0001
74060851|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.133||||0.8291|TWO_SIDED|95.0|-0.453|0.188|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)"||0.188|-0.453|.8291
74060852|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.048||||0.9997|TWO_SIDED|95.0|-0.308|0.213|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)"||0.213|-0.308|0.9997
74060853|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.172||||0.5755|TWO_SIDED|95.0|-0.145|0.488|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)"||0.488|-0.145|0.5755
74060854|NCT03692078|147674401|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.042||||0.9999|TWO_SIDED|95.0|-0.217|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)"||0.301|-0.217|0.9999
74102298|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.159||0.0008|TWO_SIDED|95.0|-0.87|-0.24|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.24|-0.87|0.0008
74102299|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.154||0.1379|TWO_SIDED|95.0|-0.54|0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.54|0.1379
74102300|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.145||0.004|TWO_SIDED|95.0|-0.71|-0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-0.71|0.0040
74102301|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.14||0.31|TWO_SIDED|95.0|-0.42|0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.42|0.3100
74102302|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.148||0.0003|TWO_SIDED|95.0|-0.85|-0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.26|-0.85|0.0003
74102303|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.143||0.0223|TWO_SIDED|95.0|-0.61|-0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.61|0.0223
74102304|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.166||0.0276|TWO_SIDED|95.0|-0.7|-0.04|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.70|0.0276
74102305|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.161||0.8516|TWO_SIDED|95.0|-0.35|0.29|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.35|0.8516
74102306|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.186||0.1669|TWO_SIDED|95.0|-0.63|0.11|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.63|0.1669
74102307|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.4935|TWO_SIDED|95.0|-0.48|0.23|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.48|0.4935
74102308|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.197||0.0202|TWO_SIDED|95.0|-0.86|-0.07|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.86|0.0202
74102309|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.188||0.2683|TWO_SIDED|95.0|-0.58|0.16|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.58|0.2683
74102310|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.165||0.0531|TWO_SIDED|95.0|-0.65|0.0|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.65|0.0531
74060855|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|2.629|||<|0.0001|TWO_SIDED|95.0|2.317|2.94|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"||2.940|2.317|<.0001
74102311|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.5609|TWO_SIDED|95.0|-0.41|0.22|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.41|0.5609
74102312|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.123||0.6779|TWO_SIDED|95.0|-0.3|0.19|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.30|0.6779
74102313|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.119||0.4559|TWO_SIDED|95.0|-0.15|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.15|0.4559
74102314|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.133||0.2254|TWO_SIDED|95.0|-0.43|0.1|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.43|0.2254
74102315|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.129||0.6437|TWO_SIDED|95.0|-0.32|0.2|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.32|0.6437
74102316|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.133||0.6678|TWO_SIDED|95.0|-0.32|0.21|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.32|0.6678
74102317|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.129||0.9321|TWO_SIDED|95.0|-0.27|0.24|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.27|0.9321
74102318|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.157||0.9778|TWO_SIDED|95.0|-0.31|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.31|0.9778
74102319|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.152||0.9307|TWO_SIDED|95.0|-0.29|0.31|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.29|0.9307
74102320|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.172||0.6791|TWO_SIDED|95.0|-0.41|0.27|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.41|0.6791
74102321|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.167||0.7769|TWO_SIDED|95.0|-0.28|0.38|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|-0.28|0.7769
74102322|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.163||0.7206|TWO_SIDED|95.0|-0.38|0.26|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.38|0.7206
74102323|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.156||0.3549|TWO_SIDED|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.45|0.3549
74060856|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.632|||<|0.0001|TWO_SIDED|95.0|2.321|2.943|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"||2.943|2.321|<.0001
74102324|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.164||0.0231|TWO_SIDED|95.0|-0.7|-0.05|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.70|0.0231
74102325|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.159||0.145|TWO_SIDED|95.0|-0.55|0.08|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.55|0.1450
74102326|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.162||0.0855|TWO_SIDED|95.0|-0.6|0.04|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.60|0.0855
74102327|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.157||0.3068|TWO_SIDED|95.0|-0.47|0.15|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.47|0.3068
74102328|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.164||0.0069|TWO_SIDED|95.0|-0.77|-0.13|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-0.77|0.0069
74102329|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.159||0.2174|TWO_SIDED|95.0|-0.51|0.12|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.51|0.2174
74102330|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.174||0.102|TWO_SIDED|95.0|-0.63|0.06|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.63|0.1020
74102331|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.9587|TWO_SIDED|95.0|-0.33|0.35|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.33|0.9587
73882015|NCT02898454|147298000|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.52|||<|0.0001|TWO_SIDED|95.0|8.98|12.07||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||12.07|8.98|<0.0001
74060857|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|2.006|||<|0.0001|TWO_SIDED|95.0|1.714|2.298|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"||2.298|1.714|<.0001
74060858|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.143|||<|0.0001|TWO_SIDED|95.0|1.847|2.44|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"||2.440|1.847|<.0001
73882016|NCT02898454|147298001|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.81||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.81|-1.15|<0.0001
74060859|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|1.987|||<|0.0001|TWO_SIDED|95.0|1.69|2.284|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"||2.284|1.690|<.0001
74060860|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.261|||<|0.0001|TWO_SIDED|95.0|1.964|2.559|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"||2.559|1.964|<.0001
74060861|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.263||||0.1658|TWO_SIDED|95.0|-0.635|0.109|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"||0.109|-0.635|0.1658
74060862|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.659||||0.0007|TWO_SIDED|95.0|-1.036|-0.282|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"||-0.282|-1.036|0.0007
74060863|NCT03692078|147674403|NON_INFERIORITY|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.302||||0.1055|TWO_SIDED|95.0|-0.667|0.064|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"||0.064|-0.667|0.1055
74060864|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.243||||0.204|TWO_SIDED|95.0|-0.617|0.132|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"||0.132|-0.617|0.2040
74060865|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.244||||0.1829|TWO_SIDED|95.0|-0.603|0.116|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"||0.116|-0.603|0.1829
74060866|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.248||||0.1801|TWO_SIDED|95.0|-0.612|0.115|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"||0.115|-0.612|0.1801
74102332|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.203||0.169|TWO_SIDED|95.0|-0.69|0.12|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.69|0.1690
74060867|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.622||||0.0391|TWO_SIDED|95.0|-1.225|-0.019|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.019|-1.225|0.0391
74060868|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.489||||0.1864|TWO_SIDED|95.0|-1.096|0.119|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.119|-1.096|0.1864
74060869|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.642||||0.031|TWO_SIDED|95.0|-1.246|-0.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.037|-1.246|0.0310
74060870|NCT03692078|147674403|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.642||||0.031|TWO_SIDED|95.0|-1.246|-0.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.037|-1.246|0.0310
74060871|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.891|||<|0.0001|TWO_SIDED|95.0|-3.58|-2.202|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.202|-3.580|<.0001
74102333|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.197||0.7919|TWO_SIDED|95.0|-0.34|0.44|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.34|0.7919
74102334|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.205||0.0192|TWO_SIDED|95.0|-0.89|-0.08|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.89|0.0192
74102335|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.196||0.3887|TWO_SIDED|95.0|-0.56|0.22|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.56|0.3887
74102336|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.189||0.0719|TWO_SIDED|95.0|-0.72|0.03|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.72|0.0719
74102337|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.185||0.1195|TWO_SIDED|95.0|-0.66|0.08|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.66|0.1195
74060872|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.291|||<|0.0001|TWO_SIDED|95.0|-3.985|-2.597|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.597|-3.985|<.0001
74060873|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.93|||<|0.0001|TWO_SIDED|95.0|-3.605|-2.255|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.255|-3.605|<.0001
74060874|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.875|||<|0.0001|TWO_SIDED|95.0|-3.559|-2.19|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.190|-3.559|<.0001
74060875|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.25|||<|0.0001|TWO_SIDED|95.0|1.604|2.896|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.896|1.604|<.0001
74060876|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.391|||<|0.0001|TWO_SIDED|95.0|1.737|3.046|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||3.046|1.737|<.0001
74060877|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.231|||<|0.0001|TWO_SIDED|95.0|1.582|2.879|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.879|1.582|<.0001
74060878|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.509|||<|0.0001|TWO_SIDED|95.0|1.857|3.162|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||3.162|1.857|<.0001
74060879|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.019||||1|TWO_SIDED|95.0|-0.743|0.705|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.705|-0.743|1.0000
74102338|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.079||0.9552|TWO_SIDED|95.0|-0.16|0.15|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.16|0.9552
73888225|NCT01746901|147309543|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.05|TWO_SIDED|95.0|0.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|0.0|0.0500
74060880|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.411||||0.5639|TWO_SIDED|95.0|-1.142|0.32|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.320|-1.142|0.5639
74102339|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.076||0.0384|TWO_SIDED|95.0|-0.31|-0.01|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.31|0.0384
74102340|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.097||0.2582|TWO_SIDED|95.0|-0.3|0.08|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.30|0.2582
74102341|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.094||0.1511|TWO_SIDED|95.0|-0.32|0.05|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.32|0.1511
74102342|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.126||0.4631|TWO_SIDED|95.0|-0.34|0.16|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.34|0.4631
74102343|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.123||0.4628|TWO_SIDED|95.0|-0.33|0.15|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.33|0.4628
74102344|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9005|TWO_SIDED|95.0|-0.23|0.2|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.23|0.9005
74102345|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.107||0.1121|TWO_SIDED|95.0|-0.38|0.04|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.38|0.1121
74102346|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.145||0.4167|TWO_SIDED|95.0|-0.4|0.17|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.40|0.4167
74102347|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.141||0.4071|TWO_SIDED|95.0|-0.4|0.16|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.40|0.4071
73888226|NCT01746901|147309544|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.34|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.34|-0.69|<0.0001
73888227|NCT01746901|147309544|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-1.86|-1.52|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.52|-1.86|<0.0001
74060881|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.058||||1|TWO_SIDED|95.0|-0.771|0.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.656|-0.771|1.0000
74060882|NCT03692078|147674403|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.006||||1|TWO_SIDED|95.0|-0.721|0.732|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.732|-0.721|1.0000
74060883|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.691|||<|0.0001|TWO_SIDED|95.0|2.519|2.863|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||2.863|2.519|<.0001
74060884|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.718|||<|0.0001|TWO_SIDED|95.0|2.546|2.89|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||2.890|2.546|<.0001
74060885|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.415|||<|0.0001|TWO_SIDED|95.0|2.252|2.577|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.577|2.252|<.0001
74060886|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.44|||<|0.0001|TWO_SIDED|95.0|2.276|2.603|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.603|2.276|<.0001
74060887|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.583|||<|0.0001|TWO_SIDED|95.0|2.417|2.748|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.748|2.417|<.0001
74102348|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1278|TWO_SIDED|95.0|-0.53|0.07|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.53|0.1278
74102349|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.145||0.0573|TWO_SIDED|95.0|-0.57|0.01|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.57|0.0573
74102350|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.156||0.4842|TWO_SIDED|95.0|-0.42|0.2|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.42|0.4842
74060888|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.591|||<|0.0001|TWO_SIDED|95.0|2.426|2.757|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.757|2.426|<.0001
74060889|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.107|||<|0.0001|TWO_SIDED|95.0|0.901|1.314|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.314|0.901|<.0001
74060890|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.017|||<|0.0001|TWO_SIDED|95.0|0.81|1.225|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.225|0.810|<.0001
74060891|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.828|||<|0.0001|TWO_SIDED|95.0|1.624|2.031|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.031|1.624|<.0001
74060892|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.782|||<|0.0001|TWO_SIDED|95.0|1.577|1.988|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.988|1.577|<.0001
74060893|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.35|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-0.350|-0.750|<.0001
74060894|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.051|-0.65|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.650|-1.051|<.0001
74060895|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.276||||0.1608|TWO_SIDED|95.0|-0.609|0.057|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.057|-0.609|0.1608
74060896|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.278||||0.1575|TWO_SIDED|95.0|-0.613|0.056|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.056|-0.613|0.1575
74102351|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.152||0.0692|TWO_SIDED|95.0|-0.58|0.02|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.58|0.0692
74102352|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.157||0.4028|TWO_SIDED|95.0|-0.44|0.18|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.44|0.4028
74060897|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.108||||0.9728|TWO_SIDED|95.0|-0.442|0.226|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.226|-0.442|0.9728
73882017|NCT02898454|147298002|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-17.36|||<|0.0001|TWO_SIDED|95.0|-20.87|-13.85||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-13.85|-20.87|<0.0001
74060898|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.127||||0.9262|TWO_SIDED|95.0|-0.461|0.208|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.208|-0.461|0.9262
74102353|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.154||0.0354|TWO_SIDED|95.0|-0.63|-0.02|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.63|0.0354
74102354|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.156||0.1228|TWO_SIDED|95.0|-0.55|0.07|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.55|0.1228
74102355|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.152||0.0099|TWO_SIDED|95.0|-0.7|-0.1|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.70|0.0099
74102356|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.164||0.2174|TWO_SIDED|95.0|-0.53|0.12|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.53|0.2174
74102357|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.161||0.082|TWO_SIDED|95.0|-0.6|0.04|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.60|0.0820
74102358|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.194||0.2642|TWO_SIDED|95.0|-0.6|0.17|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.60|0.2642
74102359|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.189||0.0718|TWO_SIDED|95.0|-0.72|0.03|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.72|0.0718
74102360|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.212||0.3055|TWO_SIDED|95.0|-0.64|0.2|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.64|0.3055
73888228|NCT01746901|147309544|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.63|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.63|-0.97|<0.0001
74060899|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.584|||<|0.0001|TWO_SIDED|95.0|-1.963|-1.204|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.204|-1.963|<.0001
74102361|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.202||0.3533|TWO_SIDED|95.0|-0.59|0.21|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.59|0.3533
74102362|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.193||0.4514|TWO_SIDED|95.0|-0.53|0.24|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.53|0.4514
74102363|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.191||0.4907|TWO_SIDED|95.0|-0.51|0.25|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.51|0.4907
74102364|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.151||0.6949|TWO_SIDED|95.0|-0.36|0.24|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.36|0.6949
74102365|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.147||0.467|TWO_SIDED|95.0|-0.4|0.18|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.40|0.4670
74102366|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.6556|TWO_SIDED|95.0|-0.39|0.25|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.39|0.6556
74102367|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.156||0.9272|TWO_SIDED|95.0|-0.32|0.29|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.32|0.9272
74102368|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.164||0.1395|TWO_SIDED|95.0|-0.57|0.08|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.57|0.1395
74102369|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.159||0.2601|TWO_SIDED|95.0|-0.5|0.14|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.50|0.2601
74060900|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.701|||<|0.0001|TWO_SIDED|95.0|-2.081|-1.32|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.320|-2.081|<.0001
74060901|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.863|||<|0.0001|TWO_SIDED|95.0|-1.237|-0.489|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.489|-1.237|<.0001
74060902|NCT03692078|147674405|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.936|||<|0.0001|TWO_SIDED|95.0|-1.312|-0.56|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.560|-1.312|<.0001
74060903|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.47|||<|0.0001|TWO_SIDED|95.0|3.31|3.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.630|3.310|<.0001
74060904|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.508|||<|0.0001|TWO_SIDED|95.0|3.348|3.668|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.668|3.348|<.0001
74060905|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.891|||<|0.0001|TWO_SIDED|95.0|2.741|3.042|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||3.042|2.741|<.0001
74060906|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.873|||<|0.0001|TWO_SIDED|95.0|2.719|3.027|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||3.027|2.719|<.0001
74060907|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.928|||<|0.0001|TWO_SIDED|95.0|2.775|3.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||3.082|2.775|<.0001
74102370|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.158||0.5626|TWO_SIDED|95.0|-0.4|0.22|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.40|0.5626
74102371|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4622|TWO_SIDED|95.0|-0.42|0.19|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.42|0.4622
74102372|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.151||0.2858|TWO_SIDED|95.0|-0.46|0.14|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.46|0.2858
74060908|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.896|||<|0.0001|TWO_SIDED|95.0|2.742|3.049|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||3.049|2.742|<.0001
74060909|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.864|||<|0.0001|TWO_SIDED|95.0|0.672|1.055|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.055|0.672|<.0001
74060910|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.786|||<|0.0001|TWO_SIDED|95.0|0.592|0.981|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.981|0.592|<.0001
74060911|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.641|||<|0.0001|TWO_SIDED|95.0|0.452|0.829|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.829|0.452|<.0001
74060912|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.485|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.680|0.290|<.0001
74060913|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.747|||<|0.0001|TWO_SIDED|95.0|0.562|0.932|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.932|0.562|<.0001
74060914|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.833|||<|0.0001|TWO_SIDED|95.0|0.645|1.021|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.021|0.645|<.0001
74060915|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.579|||<|0.0001|TWO_SIDED|95.0|-0.889|-0.268|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.268|-0.889|<.0001
74102373|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.146||0.5369|TWO_SIDED|95.0|-0.38|0.2|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.38|0.5369
74102374|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.15||0.151|TWO_SIDED|95.0|-0.52|0.08|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.52|0.1510
73882018|NCT02898454|147298003|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.21|||<|0.0001|TWO_SIDED|95.0|-2.59|-1.83||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.83|-2.59|<0.0001
73882019|NCT02898454|147298003|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.78|-2.03||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.03|-2.78|<0.0001
73882020|NCT02898454|147298004|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.92||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.92|-1.30|<0.0001
73882021|NCT02898454|147298004|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.18|-0.8||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.80|-1.18|<0.0001
73882022|NCT02898454|147298005|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.36|||<|0.0001|TWO_SIDED|95.0|-25.45|-17.27||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-17.27|-25.45|<0.0001
74060916|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.635|||<|0.0001|TWO_SIDED|95.0|-0.949|-0.321|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.321|-0.949|<.0001
74060917|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.542|||<|0.0001|TWO_SIDED|95.0|-0.853|-0.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.231|-0.853|<.0001
74060918|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.924|-0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.301|-0.924|<.0001
73882023|NCT02898454|147298005|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-20.73|||<|0.0001|TWO_SIDED|95.0|-24.81|-16.65||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-16.65|-24.81|<0.0001
73882024|NCT00647296|147298043|SUPERIORITY||Slope|-0.606|STANDARD_ERROR_OF_MEAN|0.408||0.1385|TWO_SIDED|95.0|-1.41|0.19|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||0.19|-1.41|0.1385
74060919|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.606|||<|0.0001|TWO_SIDED|95.0|-2.959|-2.253|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.253|-2.959|<.0001
74060920|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.722|||<|0.0001|TWO_SIDED|95.0|-3.078|-2.366|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.366|-3.078|<.0001
74060921|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.829|||<|0.0001|TWO_SIDED|95.0|-3.177|-2.481|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.481|-3.177|<.0001
74060922|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.024|||<|0.0001|TWO_SIDED|95.0|-3.378|-2.669|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.669|-3.378|<.0001
74102375|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.146||0.5107|TWO_SIDED|95.0|-0.38|0.19|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.38|0.5107
74102376|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.151||0.3301|TWO_SIDED|95.0|-0.45|0.15|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.45|0.3301
74060923|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.144|||<|0.0001|TWO_SIDED|95.0|1.811|2.478|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.478|1.811|<.0001
74060924|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.04|||<|0.0001|TWO_SIDED|95.0|1.701|2.379|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.379|1.701|<.0001
74060925|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.181|||<|0.0001|TWO_SIDED|95.0|1.846|2.516|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.516|1.846|<.0001
74060926|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.063|||<|0.0001|TWO_SIDED|95.0|1.725|2.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||2.400|1.725|<.0001
74060927|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.117||||0.9705|TWO_SIDED|95.0|-0.256|0.49|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.490|-0.256|0.9705
74102377|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.147||0.5139|TWO_SIDED|95.0|-0.39|0.19|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.39|0.5139
74060928|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.047||||1|TWO_SIDED|95.0|-0.425|0.332|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.332|-0.425|1.0000
74060929|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.106||||0.9835|TWO_SIDED|95.0|-0.475|0.263|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.263|-0.475|0.9835
74060930|NCT03692078|147674407|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.348||||0.0854|TWO_SIDED|95.0|-0.725|0.029|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.029|-0.725|0.0854
74060931|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.028|||<|0.0001|TWO_SIDED|95.0|2.901|3.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.154|2.901|<.0001
74060932|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.034|||<|0.0001|TWO_SIDED|95.0|2.927|3.141|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.141|2.927|<.0001
74060933|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.603|||<|0.0001|TWO_SIDED|95.0|2.483|2.722|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.722|2.483|<.0001
73882025|NCT00647296|147298043|SUPERIORITY||Slope|0.113|STANDARD_ERROR_OF_MEAN|0.39||0.7718|TWO_SIDED|95.0|-0.65|0.88|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||0.88|-0.65|0.7718
73882026|NCT00647296|147298043|SUPERIORITY||Slope|0.401|STANDARD_ERROR_OF_MEAN|0.397||0.3146|TWO_SIDED|95.0|-0.38|1.18|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||1.18|-0.38|0.3146
73882027|NCT00647296|147298044|SUPERIORITY||Slope|0.395|STANDARD_ERROR_OF_MEAN|1.536||0.7973|TWO_SIDED|95.0|-2.61|3.4|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents a better outcome.|||3.40|-2.61|0.7973
73882028|NCT00647296|147298044|SUPERIORITY||Slope|2.009|STANDARD_ERROR_OF_MEAN|1.47||0.1732|TWO_SIDED|95.0|-0.87|4.89|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||4.89|-0.87|0.1732
73882029|NCT00647296|147298044|SUPERIORITY||Slope|0.451|STANDARD_ERROR_OF_MEAN|1.497||0.7635|TWO_SIDED|95.0|-2.48|3.39|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents a better outcome.|||3.39|-2.48|0.7635
73882030|NCT00647296|147298055|SUPERIORITY||Slope|0.263|STANDARD_ERROR_OF_MEAN|0.19||0.1772|TWO_SIDED|95.0|-0.12|0.64|||Mixed Models Analysis||50 mg/day minus 150 mg/day arm, negative direction represents worse outcome.|||0.64|-0.12|0.1772
73882031|NCT00647296|147298056|SUPERIORITY||Slope|-0.615|STANDARD_ERROR_OF_MEAN|0.73||0.4025|TWO_SIDED|95.0|-2.06|0.83|||Mixed Models Analysis||50 mg/day minus 300 mg/day treatment arm, negative direction represents worse outcome.|||0.83|-2.06|0.4025
73882032|NCT03883581|147298057|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
74060934|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.567|||<|0.0001|TWO_SIDED|95.0|2.465|2.67|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.670|2.465|<.0001
74060935|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.716|||<|0.0001|TWO_SIDED|95.0|2.595|2.838|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.838|2.595|<.0001
74060936|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.643|||<|0.0001|TWO_SIDED|95.0|2.541|2.746|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.746|2.541|<.0001
74102378|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.144||0.4073|TWO_SIDED|95.0|-0.4|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.40|0.4073
74102379|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4649|TWO_SIDED|95.0|-0.38|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.38|0.4649
74102380|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.141||0.6926|TWO_SIDED|95.0|-0.34|0.22|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.34|0.6926
74102381|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.137||0.726|TWO_SIDED|95.0|-0.22|0.32|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.22|0.7260
73882033|NCT03883581|147298058|SUPERIORITY|||||||0.647|||||||Paired t test|||||||0.647
73882034|NCT03883581|147298059|SUPERIORITY|||||||0.103|||||||Paired t test|||||||0.103
74060937|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.235|||<|0.0001|TWO_SIDED|95.0|1.083|1.386|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.386|1.083|<.0001
74060938|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.174|||<|0.0001|TWO_SIDED|95.0|1.045|1.304|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.304|1.045|<.0001
74060939|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.219|||<|0.0001|TWO_SIDED|95.0|1.07|1.368|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||1.368|1.070|<.0001
73882035|NCT03883581|147298060|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
73882036|NCT03883581|147298061|SUPERIORITY|||||||0.103|||||||Paired t test|||||||0.103
73882037|NCT01908426|147298066|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0049|TWO_SIDED|95.0|0.63|0.92|||Log Rank|The Log-Rank Test was stratified by etiology of disease, geo. region, presence of extrahepatic spread of disease and/or macrovascular invasion.||||0.92|0.63|0.0049
73882038|NCT01908426|147298067|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.36|0.52|||Log Rank|The Log Rank Test was stratified by etiology of disease, geographic region, presence of extrahepatic spread of disease and/or macrovascular invasion.||||0.52|0.36|< 0.0001
73882039|NCT01908426|147298068|SUPERIORITY|||||||0.0086|||||||Cochran-Mantel-Haenszel|||||||0.0086
73882040|NCT04233008|147298079|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
73882041|NCT04233008|147298080|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
73882042|NCT04233008|147298081|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73882043|NCT04233008|147298082|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
73882044|NCT04233008|147298083|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
73882045|NCT04233008|147298085|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
73888229|NCT01746901|147309544|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.58|-1.23|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.23|-1.58|<0.0001
74060940|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.176|||<|0.0001|TWO_SIDED|95.0|1.046|1.306|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.306|1.046|<.0001
74060941|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.176|||<|0.0001|TWO_SIDED|95.0|1.029|1.322|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||1.322|1.029|<.0001
74060942|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.174|||<|0.0001|TWO_SIDED|95.0|1.049|1.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.300|1.049|<.0001
74060943|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.425|||<|0.0001|TWO_SIDED|95.0|-0.669|-0.181|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.181|-0.669|<.0001
74060944|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.467|||<|0.0001|TWO_SIDED|95.0|-0.677|-0.256|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.256|-0.677|<.0001
74060945|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.311||||0.0052|TWO_SIDED|95.0|-0.556|-0.066|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.066|-0.556|0.0052
74060946|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.391|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.182|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.182|-0.600|<.0001
74102382|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.136||0.1486|TWO_SIDED|95.0|-0.47|0.07|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.47|0.1486
74102383|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.133||0.48|TWO_SIDED|95.0|-0.36|0.17|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.36|0.4800
74102384|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.177||0.7792|TWO_SIDED|95.0|-0.4|0.3|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.40|0.7792
74102385|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.171||0.8644|TWO_SIDED|95.0|-0.31|0.37|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.31|0.8644
74102386|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.158||0.7994|TWO_SIDED|95.0|-0.27|0.35|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.27|0.7994
74102387|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|0.152||0.0811|TWO_SIDED|95.0|-0.03|0.57|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.57|-0.03|0.0811
74102388|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.144||0.6978|TWO_SIDED|95.0|-0.34|0.23|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.34|0.6978
74102389|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.9749|TWO_SIDED|95.0|-0.28|0.28|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.28|0.9749
74102390|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.081||0.3158|TWO_SIDED|95.0|-0.08|0.24|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.08|0.3158
74060947|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.793|||<|0.0001|TWO_SIDED|95.0|-2.07|-1.516|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.516|-2.070|<.0001
73888230|NCT01746901|147309544|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.56|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.56|-0.91|<0.0001
74102391|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.079||0.1901|TWO_SIDED|95.0|-0.05|0.26|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.05|0.1901
74102392|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.073||0.7229|TWO_SIDED|95.0|-0.12|0.17|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.12|0.7229
74102393|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.071||0.2715|TWO_SIDED|95.0|-0.06|0.22|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.06|0.2715
74102394|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.086||0.5421|TWO_SIDED|95.0|-0.12|0.22|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.12|0.5421
74102395|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.083||0.7215|TWO_SIDED|95.0|-0.14|0.19|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.14|0.7215
74102396|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.098||0.2246|TWO_SIDED|95.0|-0.07|0.31|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.07|0.2246
74102397|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.096||0.9671|TWO_SIDED|95.0|-0.19|0.19|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.19|0.9671
74102398|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.121||0.6527|TWO_SIDED|95.0|-0.29|0.19|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.29|0.6527
74102399|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.118||0.1647|TWO_SIDED|95.0|-0.4|0.07|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.40|0.1647
74102400|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7093|TWO_SIDED|95.0|-0.18|0.26|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.18|0.7093
74102401|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.107||0.6333|TWO_SIDED|95.0|-0.26|0.16|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.26|0.6333
74102402|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.5238|TWO_SIDED|95.0|-0.31|0.16|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.31|0.5238
74060948|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.859|||<|0.0001|TWO_SIDED|95.0|-2.098|-1.621|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.621|-2.098|<.0001
74060949|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.809|||<|0.0001|TWO_SIDED|95.0|-2.082|-1.535|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.535|-2.082|<.0001
73882046|NCT00416624|147298091|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the\> above sample size will provide an 80% power to detect a difference as small as\> 25%.|||||>|0.41|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be\> about 80% power to detect a difference through Fisher's exact test across two\> treatment arms of 25% in the true percentage of patients that experience a\> hematopoietic response as defined previously, if that percentage is at least 30% in\> the superior group, again with a 1.7% type I error rate.||||>0.41
74060950|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.858|||<|0.0001|TWO_SIDED|95.0|-2.096|-1.621|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.621|-2.096|<.0001
74060951|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.427|||<|0.0001|TWO_SIDED|95.0|1.166|1.688|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.688|1.166|<.0001
74060952|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.393|||<|0.0001|TWO_SIDED|95.0|1.166|1.62|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.620|1.166|<.0001
74102403|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.117||0.0782|TWO_SIDED|95.0|-0.44|0.02|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.44|0.0782
74102404|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.138||0.2346|TWO_SIDED|95.0|-0.44|0.11|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.44|0.2346
74102405|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.134||0.0631|TWO_SIDED|95.0|-0.52|0.01|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.52|0.0631
74102406|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.131||0.6274|TWO_SIDED|95.0|-0.32|0.2|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.32|0.6274
74102407|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.128||0.3589|TWO_SIDED|95.0|-0.37|0.14|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.37|0.3589
74102408|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.187||0.7604|TWO_SIDED|95.0|-0.43|0.31|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.43|0.7604
74102409|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.185||0.1106|TWO_SIDED|95.0|-0.66|0.07|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.66|0.1106
73888231|NCT01746901|147309544|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.46|-1.11|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.11|-1.46|<0.0001
74060953|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.541|||<|0.0001|TWO_SIDED|95.0|1.278|1.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.803|1.278|<.0001
74060954|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.469|||<|0.0001|TWO_SIDED|95.0|1.243|1.695|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.695|1.243|<.0001
74060955|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.059||||0.9987|TWO_SIDED|95.0|-0.233|0.351|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.351|-0.233|0.9987
74060956|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.253|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.254|-0.253|1.0000
74060957|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.043||||0.9999|TWO_SIDED|95.0|-0.246|0.332|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.332|-0.246|0.9999
74060958|NCT03692078|147674409|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.002||||1|TWO_SIDED|95.0|-0.251|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.254|-0.251|1.0000
74060959|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.407|||<|0.0001|TWO_SIDED|95.0|2.283|2.531|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||2.531|2.283|<.0001
74060960|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.398|||<|0.0001|TWO_SIDED|95.0|2.253|2.543|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||2.543|2.253|<.0001
74060961|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.303|||<|0.0001|TWO_SIDED|95.0|2.187|2.42|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.420|2.187|<.0001
74060962|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.25|||<|0.0001|TWO_SIDED|95.0|2.112|2.389|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.389|2.112|<.0001
74060963|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.285|||<|0.0001|TWO_SIDED|95.0|2.166|2.404|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.404|2.166|<.0001
74060964|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.272|||<|0.0001|TWO_SIDED|95.0|2.133|2.412|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.412|2.133|<.0001
74060965|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.992|||<|0.0001|TWO_SIDED|95.0|1.844|2.14|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||2.140|1.844|<.0001
74060966|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.894|||<|0.0001|TWO_SIDED|95.0|1.719|2.069|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||2.069|1.719|<.0001
74060967|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.102|||<|0.0001|TWO_SIDED|95.0|1.955|2.248|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.248|1.955|<.0001
74102410|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.222||0.9776|TWO_SIDED|95.0|-0.43|0.45|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.43|0.9776
74102411|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.217||0.3239|TWO_SIDED|95.0|-0.65|0.22|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.65|0.3239
74102412|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.238||0.6736|TWO_SIDED|95.0|-0.57|0.37|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.57|0.6736
74060968|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.075|||<|0.0001|TWO_SIDED|95.0|1.9|2.25|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||2.250|1.900|<.0001
74102413|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.231||0.6136|TWO_SIDED|95.0|-0.58|0.34|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.58|0.6136
74102414|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.195||0.1141|TWO_SIDED|95.0|-0.7|0.08|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.70|0.1141
74102415|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.194||0.2185|TWO_SIDED|95.0|-0.62|0.14|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.62|0.2185
74102416|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.054||0.6191|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6191
74102417|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.053||0.6169|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6169
74102418|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.054||0.9911|TWO_SIDED|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.11|0.9911
74102419|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.053||0.336|TWO_SIDED|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.05|0.3360
74102420|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.054||0.9638|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9638
74102421|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.053||0.161|TWO_SIDED|95.0|-0.03|0.18|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.03|0.1610
74102422|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.054||0.5763|TWO_SIDED|95.0|-0.14|0.08|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.14|0.5763
74102423|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.053||0.0599|TWO_SIDED|95.0|0.0|0.2|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|0.00|0.0599
74102424|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.054||0.3916|TWO_SIDED|95.0|-0.15|0.06|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.15|0.3916
74060969|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.89|||<|0.0001|TWO_SIDED|95.0|1.746|2.033|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||2.033|1.746|<.0001
74060970|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.944|||<|0.0001|TWO_SIDED|95.0|1.775|2.114|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||2.114|1.775|<.0001
74060971|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.104||||0.8674|TWO_SIDED|95.0|-0.345|0.137|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.137|-0.345|0.8674
74060972|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.148||||0.6519|TWO_SIDED|95.0|-0.429|0.133|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.133|-0.429|0.6519
74060973|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.122||||0.7301|TWO_SIDED|95.0|-0.363|0.119|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.119|-0.363|0.7301
74102425|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.053||0.9602|TWO_SIDED|95.0|-0.1|0.11|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.10|0.9602
74102426|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.055||0.9676|TWO_SIDED|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.11|0.9676
74102427|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.6397|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6397
74102428|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.054||0.34|TWO_SIDED|95.0|-0.05|0.16|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.05|0.3400
73888232|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.75|-1.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.42|-1.75|<0.0001
74060974|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.126||||0.8076|TWO_SIDED|95.0|-0.405|0.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.154|-0.405|0.8076
74060975|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.415||||0.0004|TWO_SIDED|95.0|-0.689|-0.142|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.142|-0.689|0.0004
74060976|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.504||||0.0002|TWO_SIDED|95.0|-0.822|-0.185|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.185|-0.822|0.0002
74060977|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.306||||0.0183|TWO_SIDED|95.0|-0.578|-0.034|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.034|-0.578|0.0183
74060978|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.323||||0.0443|TWO_SIDED|95.0|-0.641|-0.005|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.005|-0.641|0.0443
74060979|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.414||||0.0002|TWO_SIDED|95.0|0.155|0.672|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.672|0.155|0.0002
74102429|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.053||0.3472|TWO_SIDED|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.05|0.3472
74102430|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.054||0.916|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9160
74102431|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.053||0.5948|TWO_SIDED|95.0|-0.13|0.08|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.13|0.5948
74102432|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.054||0.3755|TWO_SIDED|95.0|-0.06|0.16|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.06|0.3755
73882047|NCT00416624|147298093|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 80 patients per arm will provide\> 80% power to detect differences between average hemoglobin levels in the\> reference arm and another treatment of 50% of the standard deviation. Note that\> typically one would expect the estimates for the standard deviation at a single time\> point to differ from the standard deviation for the difference from baseline.|||||>|0.13|TWO_SIDED||||||Fisher Exact|||||||>0.13
74060980|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.306||||0.0454|TWO_SIDED|95.0|0.004|0.608|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.608|0.004|0.0454
74060981|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.396||||0.0004|TWO_SIDED|95.0|0.136|0.655|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.655|0.136|0.0004
73888233|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.3309|TWO_SIDED|95.0|-0.24|0.08|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.08|-0.24|0.3309
74060982|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.328||||0.0261|TWO_SIDED|95.0|0.026|0.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.630|0.026|0.0261
74060983|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.102||||0.9455|TWO_SIDED|95.0|-0.187|0.392|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.392|-0.187|0.9455
74060984|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.05||||0.9999|TWO_SIDED|95.0|-0.387|0.287|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.287|-0.387|0.9999
74060985|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.212||||0.2633|TWO_SIDED|95.0|-0.074|0.498|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.498|-0.074|0.2633
74060986|NCT03692078|147674411|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.13||||0.8769|TWO_SIDED|95.0|-0.205|0.465|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.465|-0.205|0.8769
74060987|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|5.417|||<|0.0001|TWO_SIDED|95.0|5.315|5.52|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)||5.520|5.315|<.0001
74060988|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|5.436|||<|0.0001|TWO_SIDED|95.0|5.324|5.548|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population)||5.548|5.324|<.0001
74060989|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|4.957|||<|0.0001|TWO_SIDED|95.0|4.86|5.053|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population)||5.053|4.860|<.0001
74060990|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|4.974|||<|0.0001|TWO_SIDED|95.0|4.867|5.081|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population)||5.081|4.867|<.0001
74060991|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|4.984|||<|0.0001|TWO_SIDED|95.0|4.886|5.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population)||5.082|4.886|<.0001
74060992|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|4.975|||<|0.0001|TWO_SIDED|95.0|4.868|5.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population)||5.082|4.868|<.0001
74060993|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.49|||<|0.0001|TWO_SIDED|95.0|3.367|3.612|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population)||3.612|3.367|<.0001
74060994|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.347|||<|0.0001|TWO_SIDED|95.0|3.212|3.483|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population)||3.483|3.212|<.0001
74102433|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.053||0.9752|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9752
74102434|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.054||0.9188|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9188
74102435|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.6379|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6379
74102436|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.061||0.4967|TWO_SIDED|95.0|-0.16|0.08|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.16|0.4967
74102437|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.059||0.3492|TWO_SIDED|95.0|-0.17|0.06|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.17|0.3492
73882048|NCT00416624|147298095|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the\> above sample size will provide an 80% power to detect a difference as small as\> 25%.|||||>|0.49|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be\> about 80% power to detect a difference through Fisher's exact test across two\> treatment arms of 25% in the true percentage of patients that experience a\> hematopoietic response as defined previously, if that percentage is at least 30% in\> the superior group, again with a 1.7% type I error rate.||||>0.49
73882049|NCT00416624|147298098|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the above sample size will provide an 80% power to detect a difference as small as 25%.|||||>|0.56|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be about 80% power to detect a difference through Fisher's exact test across two treatment arms of 25% in the true percentage of patients that experience a hematopoietic response as defined previously, if that percentage is at least 30% in the superior group, again with a 1.7% type I error rate.||||>0.56
73882050|NCT00883779|147298201|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.7|||Log Rank|||||0.70|0.46|<0.0001
73882051|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.39|0.64|||Log Rank|||PFS in adenocarcinoma subgroup||0.64|0.39|<0.0001
73882052|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||=|0.579|TWO_SIDED|95.0|0.6|1.33|||Log Rank|||PFS in non-adenocarcinoma subgroup||1.33|0.60|=0.579
73882053|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.28|0.53|||Log Rank|||PFS in never smoked subgroup||0.53|0.28|<0.0001
73882054|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||=|0.2067|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||PFS in former/current smoker subgroup||1.10|0.64|=0.2067
74060995|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.539|||<|0.0001|TWO_SIDED|95.0|3.418|3.66|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population)||3.660|3.418|<.0001
74060996|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.419|||<|0.0001|TWO_SIDED|95.0|3.284|3.554|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population)||3.554|3.284|<.0001
74060997|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.492|||<|0.0001|TWO_SIDED|95.0|3.373|3.611|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population)||3.611|3.373|<.0001
73882055|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.12|0.35|||Log Rank|||PFS in subgroup EGFR mutation||0.35|0.12|<0.0001
73882056|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||=|0.7511|TWO_SIDED|95.0|0.67|1.34|||Log Rank|||PFS in subgroup EGFR wild-type||1.34|0.67|=0.7511
73882057|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||=|0.3169|TWO_SIDED|95.0|0.25|1.58|||Log Rank|||PFS in subgroup KRAS mutation||1.58|0.25|=0.3169
73882058|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.7|||Log Rank|||PFS in subgroup KRAS wild-type||0.70|0.37|<0.0001
73882059|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||=|0.0091|TWO_SIDED|95.0|0.31|0.86|||Log Rank|||PFS in subgroup EGFR IHC positive||0.86|0.31|=0.0091
73882060|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||=|0.0179|TWO_SIDED|95.0|0.18|0.88|||Log Rank|||PFS in subgroup EGFR IHC negative||0.88|0.18|=0.0179
73882061|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||=|0.0017|TWO_SIDED|95.0|0.11|0.64|||Log Rank|||PFS in subgroup EGFR FISH positive||0.64|0.11|=0.0017
73882062|NCT00883779|147298203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||=|0.188|TWO_SIDED|95.0|0.37|1.22|||Log Rank|||PFS in subgroup EGFR FISH negative||1.22|0.37|=0.1880
74060998|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.437|||<|0.0001|TWO_SIDED|95.0|3.306|3.568|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population)||3.568|3.306|<.0001
74060999|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-0.461|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population)||-0.262|-0.660|<.0001
74061000|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-0.462|||<|0.0001|TWO_SIDED|95.0|-0.679|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population)||-0.244|-0.679|<.0001
74102438|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.062||0.7136|TWO_SIDED|95.0|-0.1|0.14|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.10|0.7136
74102439|NCT02942004|147754082|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.059||0.8163|TWO_SIDED|95.0|-0.1|0.13|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.10|0.8163
74102440|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.055||0.2825|TWO_SIDED|95.0|-0.17|0.05|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.17|0.2825
74102441|NCT02942004|147754082|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.054||0.1603|TWO_SIDED|95.0|-0.18|0.03|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.18|0.1603
74102442|NCT02942004|147754083|SUPERIORITY||LS mean difference|-6.85|STANDARD_ERROR_OF_MEAN|2.414||0.0054|TWO_SIDED|95.0|-11.64|-2.07|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.07|-11.64|0.0054
74102443|NCT02942004|147754083|SUPERIORITY||LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|2.35||0.0763|TWO_SIDED|95.0|-8.86|0.45|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-8.86|0.0763
74102444|NCT02942004|147754083|SUPERIORITY||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|2.673||0.1101|TWO_SIDED|95.0|-9.6|0.99|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.99|-9.60|0.1101
74102445|NCT02942004|147754083|SUPERIORITY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|2.618||0.6167|TWO_SIDED|95.0|-6.5|3.87|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.87|-6.50|0.6167
74102446|NCT02942004|147754083|SUPERIORITY||LS mean difference|-5.64|STANDARD_ERROR_OF_MEAN|2.777||0.0447|TWO_SIDED|95.0|-11.14|-0.14|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-11.14|0.0447
73882063|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||=|0.1213|TWO_SIDED|95.0|0.7|1.04|||Log Rank|||OS in overall participants (FAS population)||1.04|0.70|=0.1213
73882064|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||=|0.0356|TWO_SIDED|95.0|0.62|0.98|||Log Rank|||OS in subgroup adenocarcinoma||0.98|0.62|=0.0356
73882065|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37|||=|0.1157|TWO_SIDED|95.0|0.92|2.03|||Log Rank|||OS in subgroup non-adenocarcinoma||2.03|0.92|=0.1157
73882066|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||=|0.0056|TWO_SIDED|95.0|0.49|0.89|||Log Rank|||OS in subgroup never smoked||0.89|0.49|=0.0056
73882067|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||=|0.3473|TWO_SIDED|95.0|0.87|1.5|||Log Rank|||OS in subgroup current/former smoker||1.50|0.87|=0.3473
73882068|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||=|0.1614|TWO_SIDED|95.0|0.45|1.14|||Log Rank|||OS in subgroup EGFR mutation||1.14|0.45|=0.1614
73882069|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||=|0.1691|TWO_SIDED|95.0|0.55|1.11|||Log Rank|||OS in subgroup EGFR wild-type||1.11|0.55|=0.1691
73882070|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||=|0.1415|TWO_SIDED|95.0|0.19|1.28|||Log Rank|||OS in subgroup KRAS mutation||1.28|0.19|=0.1415
73882071|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||=|0.1447|TWO_SIDED|95.0|0.59|1.08|||Log Rank|||OS in subgroup KRAS wild-type||1.08|0.59|=0.1447
73882072|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||=|0.031|TWO_SIDED|95.0|0.35|0.96|||Log Rank|||OS in EGFR IHC positive||0.96|0.35|=0.0310
73882073|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||=|0.0581|TWO_SIDED|95.0|0.21|1.05|||Log Rank|||OS in subgroup EGFR IHC negative||1.05|0.21|=0.0581
73882074|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||=|0.0063|TWO_SIDED|95.0|0.14|0.75|||Log Rank|||OS of subgroup EGFR FISH positive||0.75|0.14|=0.0063
73882075|NCT00883779|147298204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||=|0.3268|TWO_SIDED|95.0|0.4|1.36|||Log Rank|||OS of subgroup EGFR FISH negative||1.36|0.40|=0.3268
73882076|NCT00883779|147298206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81|||=|0.5289|TWO_SIDED|95.0|-6.2|11.8|||Chi-squared|||Difference in non-progression response rates||11.8|-6.2|=0.5289
73882077|NCT00883779|147298207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.14|||<|0.0001|TWO_SIDED|95.0|16.7|33.5|||Chi-squared|||Difference in objective response rates||33.5|16.7|<0.0001
73882078|NCT00883779|147298208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.5|||Log Rank|||||0.50|0.21|<0.0001
73882079|NCT00883779|147298209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.45|0.69|||Log Rank|||||0.69|0.45|<0.0001
73882080|NCT00883779|147298211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||=|0.0364|TWO_SIDED|95.0|0.63|0.99|||Log Rank|||||0.99|0.63|=0.0364
73882081|NCT00883779|147298213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||=|0.0181|TWO_SIDED|95.0|0.61|0.96|||Log Rank|||||0.96|0.61|=0.0181
73882082|NCT00883779|147298215|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.73|||=|0.0035|TWO_SIDED|95.0|0.59|0.9|||Log Rank|||||0.90|0.59|=0.0035
73882083|NCT00883779|147298216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.913|TWO_SIDED|95.0|0.6|1.59|||Log Rank|||||1.59|0.60|0.9130
73882084|NCT00079040|147298233|SUPERIORITY_OR_OTHER||Percentage|63.5|||||TWO_SIDED|90.0|52.4|73.6||||||||73.6|52.4|
73882085|NCT03748823|147298255|NON_INFERIORITY|Noninferiority was determined based on the 90% Confidence interval calculated from the combination z-score that accounts for the interim analysis.|Ratio of Geometric Least Squares Mean|1.257|||<|0.0001|TWO_SIDED|90.0|1.16|1.361||Analysis of variance (ANOVA) was performed on log-transformed Ctrough and included treatment and stratified weight group as fixed effects.|ANOVA||Geometric least squares mean are the least squares mean from the mixed model after back transformation to the original scale. The 90% confidence interval is presented after back transformation to the original scale.|||1.361|1.160|<0.0001
73882086|NCT00549640|147298281|SUPERIORITY_OR_OTHER|||||||0.973||95.0|||||Fisher Exact|1-tailed||||||0.973
73882087|NCT00549640|147298282|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|1 tailed test||||||0.500
73882088|NCT00549640|147298283|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|For each subject, the average daily withdrawal score for the 14 days following target quit date was calculated and expressed as a change from baseline||||||0.65
73882089|NCT00549640|147298283|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Mixed Models Analysis|analysis performed using daily scores||||||0.79
73882090|NCT00539981|147298312|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|1.07||||0.009|TWO_SIDED|95.0|0.85|1.36||Threshold for significance of p value was 0.05.|ANOVA|||A/Solomon Islands (H1N1): FluBlok: Lot A versus FluBlok: Lot B||1.36|0.85|0.009
73882091|NCT00539981|147298312|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|0.91||||0.009|TWO_SIDED|0.91|0.71|1.15||Threshold for significance of p value was 0.05.|ANOVA|||A/Solomon Islands (H1N1): FluBlok: Lot A versus FluBlok: Lot C||1.15|0.71|0.009
73882092|NCT00539981|147298312|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.85||||0.009|TWO_SIDED|95.0|0.67|1.07|||ANOVA|Threshold for significance of p value was 0.05.||A/Solomon Islands (H1N1): FluBlok: Lot B versus FluBlok: Lot C||1.07|0.67|0.009
73882093|NCT00539981|147298312|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|2.03||||0.065|TWO_SIDED|95.0|1.56|2.64||Threshold of significance for p value was 0.05.|ANOVA|||A/Wisconsin (H3N2): FluBlok: Lot A versus FluBlok: Lot B||2.64|1.56|0.065
73882094|NCT00539981|147298312|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|1.63||||0.065|TWO_SIDED|95.0|1.26|2.11|||ANOVA|Threshold of significance for p value was 0.05.||A/Wisconsin (H3N2): FluBlok: Lot A versus FluBlok: Lot C||2.11|1.26|0.065
73882095|NCT00539981|147298312|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.8||||0.065|TWO_SIDED|95.0|0.62|1.04|||ANOVA|Threshold of significance for p value was 0.05.||A/Wisconsin (H3N2): FluBlok: Lot B versus FluBlok: Lot C||1.04|0.62|0.065
73882096|NCT00539981|147298312|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|0.88||||0.011|TWO_SIDED|95.0|0.69|1.13|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot A versus FluBlok: Lot B||1.13|0.69|0.011
73882097|NCT00539981|147298312|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|0.85||||0.011|TWO_SIDED|95.0|0.65|1.09|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot A versus FluBlok: Lot C||1.09|0.65|0.011
73882098|NCT00539981|147298312|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.96||||0.011|TWO_SIDED|95.0|0.75|1.23|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot B versus FluBlok: Lot C||1.23|0.75|0.011
73882099|NCT00539981|147298313|SUPERIORITY|Relative protective efficacy is equivalent to absolute efficacy which is defined as the reduction in the influenza rate for Flublok relative to placebo.|Relative protective efficacy|75.4|||||TWO_SIDED|95.0|-148.0|99.5||||||FluBlok versus Placebo||99.5|-148.0|
73882100|NCT02675907|147298316|SUPERIORITY|||||||0.0034|||||||t-test, 2 sided|||||||0.0034
73882101|NCT02675907|147298317|SUPERIORITY||||||<|0.05||||||Row 1 (SPID6)|t-test, 2 sided|||||||<0.05
74061001|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-0.433|||<|0.0001|TWO_SIDED|95.0|-0.633|-0.233|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population)||-0.233|-0.633|<.0001
74061002|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-0.461|||<|0.0001|TWO_SIDED|95.0|-0.678|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population)||-0.244|-0.678|<.0001
74102447|NCT02942004|147754083|SUPERIORITY||LS mean difference|-3.59|STANDARD_ERROR_OF_MEAN|2.726||0.1908|TWO_SIDED|95.0|-8.99|1.81|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.81|-8.99|0.1908
73882102|NCT02675907|147298317|SUPERIORITY||||||<|0.01||||||Row 2 (SPID12)|t-test, 2 sided|||||||<0.01
73882103|NCT02675907|147298317|SUPERIORITY||||||<|0.01||||||Row 3 (SPID24)|t-test, 2 sided|||||||<0.01
73882104|NCT02675907|147298317|SUPERIORITY||||||<|0.01||||||Row 4 (SPID12-48)|t-test, 2 sided|||||||<0.01
73882105|NCT02675907|147298317|SUPERIORITY||||||<|0.01||||||Row 5 (SPID24-48)|t-test, 2 sided|||||||<0.01
73882106|NCT02675907|147298318|SUPERIORITY|||||||0.0076|||||||Log Rank|||||||0.0076
73882107|NCT02675907|147298319|SUPERIORITY||||||<|0.001||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel|||||||<0.001
73882108|NCT02675907|147298319|SUPERIORITY||||||<|0.01||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel|||||||<0.01
73882109|NCT02675907|147298319|SUPERIORITY||||||<|0.01||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel|||||||<0.01
73882110|NCT02675907|147298320|SUPERIORITY||||||<|0.05||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
73882111|NCT02675907|147298320|SUPERIORITY||||||<|0.05||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
73882112|NCT02675907|147298320|SUPERIORITY||||||<|0.05||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
73882113|NCT02675907|147298321|SUPERIORITY|||||||0.1228|||||||Log Rank|||||||0.1228
73882114|NCT02675907|147298322|SUPERIORITY|||||||0.1048|||||||Log Rank|||||||0.1048
73882115|NCT02675907|147298323|SUPERIORITY|||||||0.0451|||||||Cochran-Mantel-Haenszel|||||||0.0451
73882116|NCT02675907|147298324|SUPERIORITY|||||||0.0107|||||||Cochran-Mantel-Haenszel|||||||0.0107
73882117|NCT02675907|147298325|SUPERIORITY|||||||0.0781|||||||Cochran-Mantel-Haenszel|||||||0.0781
73882118|NCT02675907|147298326|SUPERIORITY|||||||0.043|||||||Cochran-Mantel-Haenszel|||||||0.0430
73882119|NCT02675907|147298327|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.1070
73882120|NCT02675907|147298328|SUPERIORITY|||||||0.0046|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0046
73882121|NCT01611792|147298329|SUPERIORITY||Mean Difference (Net)|-10.0|STANDARD_DEVIATION|9.02|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<.0001
73882122|NCT01611792|147298330|SUPERIORITY||Mean Difference (Net)|-6.67|STANDARD_DEVIATION|11.86||0.0038|TWO_SIDED||||||Mixed Models Analysis|||||||0.0038
73882123|NCT01611792|147298331|SUPERIORITY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|5.36||0.36|TWO_SIDED||||||Mixed Models Analysis|||||||0.36
73882124|NCT01611792|147298332|SUPERIORITY||Mean Difference (Net)|-1.31|STANDARD_DEVIATION|1.98||0.0018|TWO_SIDED||||||Mixed Models Analysis|||||||0.0018
74061003|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-1.928|||<|0.0001|TWO_SIDED|95.0|-2.154|-1.701|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population)||-1.701|-2.154|<.0001
74061004|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-2.089|||<|0.0001|TWO_SIDED|95.0|-2.336|-1.842|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population)||-1.842|-2.336|<.0001
74061005|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-1.879|||<|0.0001|TWO_SIDED|95.0|-2.102|-1.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population)||-1.656|-2.102|<.0001
74061006|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-2.017|||<|0.0001|TWO_SIDED|95.0|-2.262|-1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population)||-1.772|-2.262|<.0001
74061007|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|1.465|||<|0.0001|TWO_SIDED|95.0|1.25|1.679|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population)||1.679|1.250|<.0001
74061008|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|1.537|||<|0.0001|TWO_SIDED|95.0|1.303|1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population)||1.772|1.303|<.0001
74061009|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|1.492|||<|0.0001|TWO_SIDED|95.0|1.277|1.707|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population)||1.707|1.277|<.0001
74102448|NCT02942004|147754084|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0131|TWO_SIDED|95.0|1.3|11.7|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||11.7|1.3|0.0131
74102449|NCT02942004|147754084|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0095|TWO_SIDED|95.0|1.4|11.6|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||11.6|1.4|0.0095
74102450|NCT02942004|147754084|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0323|TWO_SIDED|95.0|1.1|7.5|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||7.5|1.1|0.0323
74102451|NCT02942004|147754084|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0931|TWO_SIDED|95.0|0.9|5.3|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||5.3|0.9|0.0931
74061010|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|1.538|||<|0.0001|TWO_SIDED|95.0|1.304|1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population)||1.772|1.304|<.0001
74061011|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|-0.003||||1|TWO_SIDED|95.0|-0.242|0.237|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population)||0.237|-0.242|1.0000
74061012|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|-0.09||||0.9399|TWO_SIDED|95.0|-0.351|0.172|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population)||0.172|-0.351|0.9399
74061013|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|0.047||||0.9993|TWO_SIDED|95.0|-0.19|0.283|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population)||0.283|-0.190|0.9993
74102452|NCT02942004|147754084|SUPERIORITY||Odds Ratio (OR)|3.6||||0.0139|TWO_SIDED|95.0|1.3|10.0|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||10.0|1.3|0.0139
74102453|NCT02942004|147754084|SUPERIORITY||Odds Ratio (OR)|2.6||||0.046|TWO_SIDED|95.0|1.0|6.9|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||6.9|1.0|0.0460
74102454|NCT02942004|147754085|SUPERIORITY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|1.454||0.4389|TWO_SIDED|95.0|-4.01|1.75|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.75|-4.01|0.4389
74102455|NCT02942004|147754085|SUPERIORITY||LS mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.427||0.4645|TWO_SIDED|95.0|-3.88|1.78|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.78|-3.88|0.4645
74102456|NCT02942004|147754085|SUPERIORITY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.356||0.0622|TWO_SIDED|95.0|-5.24|0.13|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-5.24|0.0622
74102457|NCT02942004|147754085|SUPERIORITY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|1.338||0.8495|TWO_SIDED|95.0|-2.4|2.91|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.91|-2.40|0.8495
74102458|NCT02942004|147754085|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.59||0.7063|TWO_SIDED|95.0|-3.75|2.55|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.55|-3.75|0.7063
74102459|NCT02942004|147754085|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|1.552||0.9434|TWO_SIDED|95.0|-3.19|2.97|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.97|-3.19|0.9434
73882125|NCT01611792|147298333|SUPERIORITY||Mean Difference (Net)|0.69|STANDARD_DEVIATION|2.12||0.19|TWO_SIDED||||||Mixed Models Analysis|||||||0.19
73882126|NCT01611792|147298334|SUPERIORITY||Mean Difference (Net)|0.69|STANDARD_DEVIATION|2.12||0.19|TWO_SIDED||||||Mixed Models Analysis|||||||0.19
74102460|NCT02942004|147754085|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|1.608||0.9701|TWO_SIDED|95.0|-3.25|3.13|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.13|-3.25|0.9701
74102461|NCT02942004|147754085|SUPERIORITY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|1.566||0.6307|TWO_SIDED|95.0|-3.86|2.35|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.35|-3.86|0.6307
74102462|NCT02942004|147754085|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|1.488||0.1767|TWO_SIDED|95.0|-4.97|0.93|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.93|-4.97|0.1767
73882127|NCT00591006|147298337|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<0.01
73882128|NCT00591006|147298337|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||.12
73882129|NCT00591006|147298337|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Mixed Models Analysis|||||||.15
74061014|NCT03692078|147674413|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|-0.018||||1|TWO_SIDED|95.0|-0.278|0.242|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population)||0.242|-0.278|1.0000
74061015|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.805|||<|0.0001|TWO_SIDED|95.0|1.639|1.971|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.971|1.639|<.0001
74061016|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.788|||<|0.0001|TWO_SIDED|95.0|1.622|1.954|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.954|1.622|<.0001
73882130|NCT00591006|147298337|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||.10
73882131|NCT00591006|147298338|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
73882132|NCT00591006|147298338|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
73882133|NCT00591006|147298338|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
73882134|NCT00591006|147298338|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||.02
73882135|NCT00591006|147298339|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
73882136|NCT00591006|147298339|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
73882137|NCT00591006|147298339|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||.11
73882138|NCT00591006|147298339|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||.06
73882139|NCT03174184|147298352|EQUIVALENCE|Equivalence tests will be conducted to examine whether the EBA0-14CFU of Arm A is different from the EBA0-14CFU of Arm B. A similar comparison will be done comparing Arm C to Arm D, Arm A to Arm C, Arm D to Arm E, Arm D to Arm F, and Arm E to Arm F.|||||<|0.001|||||||Regression, Linear|||||||<0.001
73882140|NCT00525512|147298370|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.13||||0.1062||95.0|0.97|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.32|0.97|0.1062
73882141|NCT00525512|147298371|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.12||||0.008||95.0|1.03|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.23|1.03|0.008
73882142|NCT00525512|147298372|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.1||||0.0597||95.0|1.0|1.21||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.21|1.00|0.0597
73882143|NCT00525512|147298373|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.15||||0.0131||95.0|1.03|1.29||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.29|1.03|0.0131
73882144|NCT00525512|147298374|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.18||||0.0041||95.0|1.05|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.32|1.05|0.0041
73882145|NCT00525512|147298375|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.11||||0.0945||95.0|0.98|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.26|0.98|0.0945
74061017|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.29|||<|0.0001|TWO_SIDED|95.0|1.145|1.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.462|1.145|<.0001
74061018|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.304|||<|0.0001|TWO_SIDED|95.0|1.134|1.447|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.447|1.134|<.0001
74061019|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.353|||<|0.0001|TWO_SIDED|95.0|1.194|1.513|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.513|1.194|<.0001
74061020|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.313|||<|0.0001|TWO_SIDED|95.0|1.153|1.472|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.472|1.153|<.0001
74061021|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.956|||<|0.0001|TWO_SIDED|95.0|-1.155|-0.756|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-0.756|-1.155|<.0001
74061022|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.114|||<|0.0001|TWO_SIDED|95.0|-1.315|-0.913|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-0.913|-1.315|<.0001
74061023|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.999|||<|0.0001|TWO_SIDED|95.0|-1.195|-0.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-0.803|-1.195|<.0001
74061024|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.164|||<|0.0001|TWO_SIDED|95.0|-1.364|-0.964|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-0.964|-1.364|<.0001
74061025|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.775|||<|0.0001|TWO_SIDED|95.0|-0.969|-0.582|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-0.582|-0.969|<.0001
74061026|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.795|||<|0.0001|TWO_SIDED|95.0|-0.99|-0.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.600|-0.990|<.0001
74061027|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.514||||0.0002|TWO_SIDED|95.0|-0.836|-0.193|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.193|-0.836|0.0002
74061028|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.484||||0.0005|TWO_SIDED|95.0|-0.808|-0.16|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.160|-0.808|0.0005
74061029|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.452||||0.0014|TWO_SIDED|95.0|-0.775|-0.128|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.128|-0.775|0.0014
74061030|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.475||||0.0007|TWO_SIDED|95.0|-0.799|-0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.152|-0.799|0.0007
74061031|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.127|-2.394|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.394|-3.127|<.0001
74061032|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.902|||<|0.0001|TWO_SIDED|95.0|-3.271|-2.533|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.533|-3.271|<.0001
74061033|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.804|||<|0.0001|TWO_SIDED|95.0|-3.165|-2.443|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.443|-3.165|<.0001
74102463|NCT02942004|147754085|SUPERIORITY||LS mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.468||0.3236|TWO_SIDED|95.0|-4.37|1.45|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.45|-4.37|0.3236
74102464|NCT06133348|147754134|OTHER|Single group|Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|6.9||0.0089|TWO_SIDED|95.0|0.9|5.8|||Paired t-Test|||||5.8|0.9|0.0089
74102465|NCT06133348|147754135|OTHER|Single group|Mean Difference (Final Values)|10.4|STANDARD_DEVIATION|23.8||0.0169|TWO_SIDED|95.0|2.0|18.8|||Paired t-Test|||||18.8|2|0.0169
73882146|NCT00525512|147298376|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.12||||0.0899||95.0|0.98|1.28||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.28|0.98|0.0899
74061034|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.952|||<|0.0001|TWO_SIDED|95.0|-3.317|-2.587|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.587|-3.317|<.0001
74061035|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.066|||<|0.0001|TWO_SIDED|95.0|1.719|2.413|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.413|1.719|<.0001
74061036|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.099|||<|0.0001|TWO_SIDED|95.0|1.748|2.449|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.449|1.748|<.0001
74061037|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.129|||<|0.0001|TWO_SIDED|95.0|1.779|2.478|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.478|1.779|<.0001
74061038|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.107|||<|0.0001|TWO_SIDED|95.0|1.756|2.459|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||2.459|1.756|<.0001
74061039|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.18||||0.7678|TWO_SIDED|95.0|-0.569|0.209|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.209|-0.569|0.7678
74061040|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.319||||0.1691|TWO_SIDED|95.0|-0.711|0.073|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.073|-0.711|0.1691
74061041|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.224||||0.5178|TWO_SIDED|95.0|-0.606|0.158|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.158|-0.606|0.5178
74061042|NCT03692078|147674415|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.369||||0.0699|TWO_SIDED|95.0|-0.757|0.018|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.018|-0.757|0.0699
74102466|NCT06133348|147754136|OTHER|Single group|Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|5.3||0.0162|TWO_SIDED|95.0|0.5|4.3|||Paired t-Test|||||4.3|0.5|0.0162
74102467|NCT06133348|147754137|OTHER|Single group|Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|7.6||0.0144|TWO_SIDED|95.0|0.7|6.1|||Paired t-Test|||||6.1|0.7|0.0144
74061043|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.177|||<|0.0001|TWO_SIDED|95.0|6.062|6.292|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||6.292|6.062|<.0001
74061044|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.197|||<|0.0001|TWO_SIDED|95.0|6.082|6.312|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||6.312|6.082|<.0001
74061045|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.798|||<|0.0001|TWO_SIDED|95.0|5.69|5.906|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||5.906|5.690|<.0001
74061046|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.82|||<|0.0001|TWO_SIDED|95.0|5.71|5.93|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||5.930|5.710|<.0001
74061047|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.863|||<|0.0001|TWO_SIDED|95.0|5.753|5.974|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||5.974|5.753|<.0001
74061048|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.816|||<|0.0001|TWO_SIDED|95.0|5.706|5.927|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||5.927|5.706|<.0001
74061049|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.947|||<|0.0001|TWO_SIDED|95.0|4.809|5.084|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||5.084|4.809|<.0001
74061050|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.913|||<|0.0001|TWO_SIDED|95.0|4.774|5.052|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||5.052|4.774|<.0001
74102468|NCT06133348|147754138|OTHER|Single group|Mean Difference (Final Values)|2.9|STANDARD_DEVIATION|7.3||0.0264|TWO_SIDED|95.0|0.4|5.5|||Paired t-Test|||||5.5|0.4|0.0264
74102469|NCT06133348|147754139|OTHER|Single group|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|2.7||0.1622|TWO_SIDED|95.0|-0.3|1.6|||Paired t-Test|||||1.6|-0.3|0.1622
74102470|NCT06133348|147754140|OTHER|Single group|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|4.0||0.1506|TWO_SIDED|95.0|-0.4|2.5|||Paired t-Test|||||2.5|-0.4|0.1506
74102471|NCT06133348|147754141|OTHER|Single group|Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|5.5||0.0012|TWO_SIDED|95.0|1.5|5.4|||Paired t-Test|||||5.4|1.5|0.0012
74102472|NCT06133348|147754142|OTHER|Single group|Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|2.1||0.0021|TWO_SIDED|95.0|0.5|2.0|||Paired t-Test|||||2|0.5|0.0021
74102473|NCT06133348|147754143|OTHER|Single group|Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|2.6||0.0027|TWO_SIDED|95.0|0.6|2.4|||Paired t-Test|||||2.4|0.6|0.0027
74061051|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.862|||<|0.0001|TWO_SIDED|95.0|4.727|4.998|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||4.998|4.727|<.0001
74061052|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.938|||<|0.0001|TWO_SIDED|95.0|4.799|5.076|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||5.076|4.799|<.0001
74061053|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.826|||<|0.0001|TWO_SIDED|95.0|4.693|4.959|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||4.959|4.693|<.0001
74061054|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.902|||<|0.0001|TWO_SIDED|95.0|4.767|5.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||5.037|4.767|<.0001
74061055|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.379|||<|0.0001|TWO_SIDED|95.0|-0.602|-0.156|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.156|-0.602|<.0001
74061056|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.376|||<|0.0001|TWO_SIDED|95.0|-0.601|-0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.152|-0.601|<.0001
74061057|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.314||||0.0014|TWO_SIDED|95.0|-0.537|-0.09|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.090|-0.537|0.0014
74061058|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.381|||<|0.0001|TWO_SIDED|95.0|-0.604|-0.157|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.157|-0.604|<.0001
74102474|NCT06133348|147754144|OTHER|Single group|Mean Difference (Final Values)|0.697|STANDARD_DEVIATION|2.0||0.0494|TWO_SIDED|95.0|0.0|1.4|||Paired t-Test|||||1.4|0.0|0.0494
74102475|NCT06133348|147754145|OTHER|Single group|Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|4.8||0.4707|TWO_SIDED|95.0|-1.1|2.3|||Paired t-Test|||||2.3|-1.1|0.4707
74102476|NCT06133348|147754146|OTHER|Single group|Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|5.1||0.0082|TWO_SIDED|95.0|-4.3|-0.7|||Paired t-Test|||||-0.7|-4.3|0.0082
74102477|NCT06133348|147754147|OTHER|Single group|Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|4.3||0.1327|TWO_SIDED|95.0|-2.7|0.4|||Paired t-Test|||||0.4|-2.7|0.1327
74102478|NCT06133348|147754148|OTHER|Single group|Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|5.0||0.2046|TWO_SIDED|95.0|-2.9|0.6|||Paired t-Test|||||0.6|-2.9|0.2046
74102479|NCT06133348|147754149|OTHER|Single group|Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|5.9||0.5252|TWO_SIDED|95.0|-2.8|1.4|||Paired t-Test|||||1.4|-2.8|0.5252
74061059|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.484|-0.977|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.977|-1.484|<.0001
74061060|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.284|||<|0.0001|TWO_SIDED|95.0|-1.539|-1.029|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.029|-1.539|<.0001
74061061|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.315|||<|0.0001|TWO_SIDED|95.0|-1.564|-1.065|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.065|-1.564|<.0001
74061062|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.259|||<|0.0001|TWO_SIDED|95.0|-1.512|-1.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.006|-1.512|<.0001
74061063|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.972|||<|0.0001|TWO_SIDED|95.0|0.732|1.211|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.211|0.732|<.0001
74061064|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.918|||<|0.0001|TWO_SIDED|95.0|0.676|1.161|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.161|0.676|<.0001
74061065|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.037|||<|0.0001|TWO_SIDED|95.0|0.797|1.278|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.278|0.797|<.0001
74061066|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.914|||<|0.0001|TWO_SIDED|95.0|0.672|1.156|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.156|0.672|<.0001
74061067|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.121||||0.7939|TWO_SIDED|95.0|-0.147|0.388|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.388|-0.147|0.7939
74102480|NCT06133348|147754150|OTHER|Single group|Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|6.0||0.4569|TWO_SIDED|95.0|-1.3|2.9|||Paired t-Test|||||2.9|-1.3|0.4569
74061068|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.011||||1|TWO_SIDED|95.0|-0.26|0.281|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.281|-0.260|1.0000
74061069|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.036||||1|TWO_SIDED|95.0|-0.228|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.301|-0.228|1.0000
74061070|NCT03692078|147674417|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.036||||1|TWO_SIDED|95.0|-0.233|0.305|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.305|-0.233|1.0000
74061071|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|7.367|||<|0.0001|TWO_SIDED|95.0|7.25|7.485|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||7.485|7.250|<.0001
74061072|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|7.368|||<|0.0001|TWO_SIDED|95.0|7.251|7.485|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||7.485|7.251|<.0001
74102481|NCT06133348|147754151|OTHER|Single group|Mean Difference (Final Values)|12.2|STANDARD_DEVIATION|40.8||0.1497|TWO_SIDED|95.0|-4.7|29.0|||Paired t-Test|||||29.0|-4.7|0.1497
74102482|NCT06133348|147754152|OTHER|Single group|Mean Difference (Final Values)|16.6|STANDARD_DEVIATION|65.5||0.2163|TWO_SIDED|95.0|-10.4|43.7|||Paired t-Test|||||43.7|-10.4|0.2163
74102483|NCT06133348|147754153|OTHER|Single group|Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|10.1||0.0915|TWO_SIDED|95.0|-0.6|7.7|||Paired t-Test|||||7.7|-0.6|0.0915
74102484|NCT06133348|147754154|OTHER|Single group|Mean Difference (Final Values)|5.3|STANDARD_DEVIATION|28.1||0.3573|TWO_SIDED|95.0|-6.3|16.9|||Paired t-Test|||||16.9|-6.3|0.3573
73882147|NCT00525512|147298377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|||<|0.0001||95.0|0.073|0.16||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.160|0.073|<0.0001
74102485|NCT06133348|147754155|OTHER|Single group|Mean Difference (Final Values)|-0.9|STANDARD_DEVIATION|4.7||0.3741|TWO_SIDED|95.0|-2.8|1.1|||Paired t-Test|||||1.1|-2.8|0.3741
74102486|NCT06133348|147754156|OTHER|Single group|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.4||0.6187|TWO_SIDED|95.0|-0.6|1.0|||Paired t-Test|||||1.0|-0.6|0.6187
74102487|NCT06133348|147754157|OTHER|Single group|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.2||0.3572|TWO_SIDED|95.0|-0.04|0.1|||Paired t-Test|||||0.1|-0.04|0.3572
74102488|NCT06133348|147754158|OTHER|Single group|Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|5.8||0.108|TWO_SIDED|95.0|-0.5|4.3|||Paired t-Test|||||4.3|-0.5|0.1080
74102489|NCT06133348|147754159|OTHER|Single group|Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|3.7||0.2088|TWO_SIDED|95.0|-0.6|2.5|||Paired t-Test|||||2.5|-0.6|0.2088
74102490|NCT06133348|147754162|OTHER|Single group|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.4||0.7333|TWO_SIDED|95.0|-0.1|0.2|||Paired t-Test|||||0.2|-0.1|0.7333
74102491|NCT06133348|147754163|OTHER|Single group|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|2.5||0.6382|TWO_SIDED|95.0|-0.8|1.3|||Paired t-Test|||||1.3|-0.8|0.6382
74102492|NCT06133348|147754164|OTHER|Single group|Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|1.4||0.4771|TWO_SIDED|95.0|-0.8|0.4|||Paired t-Test|||||0.4|-0.8|0.4771
74102493|NCT04424407|147754178|OTHER|||||||0.008||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (3) in the Conscious Faces task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Conscious Fear \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.008
73882148|NCT00525512|147298378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082||||0.0005||95.0|0.036|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.128|0.036|0.0005
74061073|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.883|||<|0.0001|TWO_SIDED|95.0|6.773|6.994|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||6.994|6.773|<.0001
74061074|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.892|||<|0.0001|TWO_SIDED|95.0|6.78|7.004|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||7.004|6.780|<.0001
74061075|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.942|||<|0.0001|TWO_SIDED|95.0|6.829|7.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||7.054|6.829|<.0001
74061076|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.896|||<|0.0001|TWO_SIDED|95.0|6.784|7.008|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||7.008|6.784|<.0001
74102494|NCT04424407|147754178|OTHER|||||||0.08||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (3) in the Conscious Faces task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Conscious Threat \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.08
73882149|NCT00525512|147298379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089||||0.0003||95.0|0.041|0.137||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.137|0.041|0.0003
73882150|NCT00525512|147298380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|||<|0.0001||95.0|0.058|0.153||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.153|0.058|<0.0001
73882151|NCT00525512|147298381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0005||95.0|0.04|0.141||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.141|0.040|0.0005
73882152|NCT00525512|147298382|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.094||||0.0002||95.0|0.045|0.144||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.144|0.045|0.0002
74061077|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.879|||<|0.0001|TWO_SIDED|95.0|5.739|6.019|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||6.019|5.739|<.0001
74061078|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.804|||<|0.0001|TWO_SIDED|95.0|5.662|5.946|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||5.946|5.662|<.0001
74061079|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.916|||<|0.0001|TWO_SIDED|95.0|5.778|6.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||6.054|5.778|<.0001
74061080|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.917|||<|0.0001|TWO_SIDED|95.0|5.775|6.058|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||6.058|5.775|<.0001
74061081|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.017|||<|0.0001|TWO_SIDED|95.0|5.881|6.153|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||6.153|5.881|<.0001
74061082|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.012|||<|0.0001|TWO_SIDED|95.0|5.874|6.149|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||6.149|5.874|<.0001
74061083|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.484|||<|0.0001|TWO_SIDED|95.0|-0.711|-0.257|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.257|-0.711|<.0001
74061084|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.476|||<|0.0001|TWO_SIDED|95.0|-0.705|-0.248|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.248|-0.705|<.0001
74061085|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.426|||<|0.0001|TWO_SIDED|95.0|-0.654|-0.198|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.198|-0.654|<.0001
74061086|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.472|||<|0.0001|TWO_SIDED|95.0|-0.701|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.244|-0.701|<.0001
74061087|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.489|||<|0.0001|TWO_SIDED|95.0|-1.747|-1.23|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.230|-1.747|<.0001
74061088|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Final Values)|-1.564|||<|0.0001|TWO_SIDED|95.0|-1.825|-1.304|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.304|-1.825|<.0001
74061089|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.451|||<|0.0001|TWO_SIDED|95.0|-1.706|-1.197|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.197|-1.706|<.0001
74061090|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.452|||<|0.0001|TWO_SIDED|95.0|-1.71|-1.193|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.193|-1.710|<.0001
74061091|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.866|||<|0.0001|TWO_SIDED|95.0|0.622|1.11|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.110|0.622|<.0001
74061092|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.88|||<|0.0001|TWO_SIDED|95.0|0.633|1.128|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.128|0.633|<.0001
74061093|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.924|||<|0.0001|TWO_SIDED|95.0|0.68|1.169|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.169|0.680|<.0001
74061094|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.884|||<|0.0001|TWO_SIDED|95.0|0.638|1.131|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.131|0.638|<.0001
74061095|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.138||||0.68|TWO_SIDED|95.0|-0.411|0.134|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.134|-0.411|0.6800
74061096|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.208||||0.2371|TWO_SIDED|95.0|-0.483|0.068|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.068|-0.483|0.2371
74061097|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||0.9133|TWO_SIDED|95.0|-0.371|0.169|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.169|-0.371|0.9133
74061098|NCT03692078|147674419|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.095||||0.9432|TWO_SIDED|95.0|-0.37|0.18|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.180|-0.370|0.9432
74061099|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.513|||<|0.0001|TWO_SIDED|95.0|4.383|4.643|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||4.643|4.383|<.0001
74061100|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.491|||<|0.0001|TWO_SIDED|95.0|4.371|4.61|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||4.610|4.371|<.0001
74061101|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.15|||<|0.0001|TWO_SIDED|95.0|4.027|4.272|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||4.272|4.027|<.0001
74061102|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.128|||<|0.0001|TWO_SIDED|95.0|4.014|4.242|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||4.242|4.014|<.0001
74061103|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.176|||<|0.0001|TWO_SIDED|95.0|4.051|4.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||4.301|4.051|<.0001
74061104|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.139|||<|0.0001|TWO_SIDED|95.0|4.024|4.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||4.254|4.024|<.0001
74061105|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.997|||<|0.0001|TWO_SIDED|95.0|2.842|3.153|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||3.153|2.842|<.0001
74061106|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.994|||<|0.0001|TWO_SIDED|95.0|2.849|3.138|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||3.138|2.849|<.0001
74061107|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.317|||<|0.0001|TWO_SIDED|95.0|3.164|3.47|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||3.470|3.164|<.0001
74061108|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.342|||<|0.0001|TWO_SIDED|95.0|3.199|3.486|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||3.486|3.199|<.0001
74102495|NCT04424407|147754178|OTHER|||||||0.49||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (3) in the Conscious Faces task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Conscious Anger \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.49
74102496|NCT04424407|147754179|OTHER|||||||0.99||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (3) in the Nonconscious Faces task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Nonconscious Fear \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.99
74102497|NCT04424407|147754179|OTHER|||||||0.99||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (3) in the Nonconscious Faces task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Nonconscious Threat \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.99
74102498|NCT04424407|147754180|OTHER|||||||0.65||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (2) in the Emotion Regulation Scenes task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Emotion Regulation Scenes task Negative \> Neutral amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.65
74061109|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.036|||<|0.0001|TWO_SIDED|95.0|2.886|3.187|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||3.187|2.886|<.0001
74061110|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.159|||<|0.0001|TWO_SIDED|95.0|3.019|3.299|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||3.299|3.019|<.0001
74061111|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.363||||0.0008|TWO_SIDED|95.0|-0.613|-0.113|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.113|-0.613|0.0008
74061112|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.362||||0.0003|TWO_SIDED|95.0|-0.595|-0.129|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.129|-0.595|0.0003
74061113|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.337||||0.0026|TWO_SIDED|95.0|-0.588|-0.085|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.085|-0.588|0.0026
74061114|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.351||||0.0004|TWO_SIDED|95.0|-0.584|-0.118|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.118|-0.584|0.0004
74061115|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.515|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.23|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.230|-1.800|<.0001
74061116|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.497|||<|0.0001|TWO_SIDED|95.0|-1.762|-1.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.231|-1.762|<.0001
74061117|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.196|||<|0.0001|TWO_SIDED|95.0|-1.477|-0.915|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.915|-1.477|<.0001
74061118|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.148|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.886|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.886|-1.410|<.0001
74102499|NCT04424407|147754180|OTHER|||||||0.65||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of contrasts (2) in the Emotion Regulation Scenes task. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of Emotion Regulation Scenes task Look Negative \> Decrease Negative amygdala reactivity was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.65
74102500|NCT04424407|147754181|OTHER|||||||0.86||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of mPFC regions (5). The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of amygdala-dACC connectivity from the Conscious Fear \> Neutral task/contrast was done by applying linear mixed effects models testing the effect of treatment-time on connectivity. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.86
74061119|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.113|||<|0.0001|TWO_SIDED|95.0|0.844|1.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.382|0.844|<.0001
74061120|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.969|||<|0.0001|TWO_SIDED|95.0|0.717|1.221|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.221|0.717|<.0001
74061121|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.139|||<|0.0001|TWO_SIDED|95.0|0.869|1.41|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.410|0.869|<.0001
74061122|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.98|||<|0.0001|TWO_SIDED|95.0|0.728|1.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.231|0.728|<.0001
74061123|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.039||||1|TWO_SIDED|95.0|-0.34|0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.262|-0.340|1.0000
74061124|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.166||||0.5184|TWO_SIDED|95.0|-0.447|0.115|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.115|-0.447|0.5184
74061125|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.28||||0.0743|TWO_SIDED|95.0|-0.017|0.578|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.578|-0.017|0.0743
74102501|NCT04424407|147754181|OTHER|||||||0.86||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of mPFC regions (5). The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of amygdala-dmPFC connectivity from the Conscious Fear \> Neutral task/contrast was done by applying linear mixed effects models testing the effect of treatment-time on connectivity. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.86
74102502|NCT04424407|147754181|OTHER|||||||0.83||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of mPFC regions (5). The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of amygdala-pACC connectivity from the Conscious Fear \> Neutral task/contrast was done by applying linear mixed effects models testing the effect of treatment-time on connectivity. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.83
73882153|NCT00525512|147298383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075||||0.0059||95.0|0.022|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.128|0.022|0.0059
74061126|NCT03692078|147674421|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.183||||0.3889|TWO_SIDED|95.0|-0.095|0.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.462|-0.095|0.3889
74061127|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.264|||<|0.0001|TWO_SIDED|95.0|5.155|5.373|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||5.373|5.155|<.0001
74061128|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.204|||<|0.0001|TWO_SIDED|95.0|5.106|5.302|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||5.302|5.106|<.0001
74061129|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.005|||<|0.0001|TWO_SIDED|95.0|4.902|5.108|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||5.108|4.902|<.0001
74102503|NCT04424407|147754181|OTHER|||||||0.23||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of mPFC regions (5). The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of amygdala-sgACC connectivity from the Conscious Fear \> Neutral task/contrast was done by applying linear mixed effects models testing the effect of treatment-time on connectivity. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.23
74061130|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.958|||<|0.0001|TWO_SIDED|95.0|4.864|5.051|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||5.051|4.864|<.0001
74061131|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.114|||<|0.0001|TWO_SIDED|95.0|5.009|5.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||5.219|5.009|<.0001
74061132|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.052|||<|0.0001|TWO_SIDED|95.0|4.958|5.146|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||5.146|4.958|<.0001
74102504|NCT04424407|147754181|OTHER|||||||0.83||||||P-values from linear mixed effects models were False Discovery Rate-adjusted (Benjamini-Hochberg method) for the number of mPFC regions (5). The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of amygdala-vmPFC connectivity from the Conscious Fear \> Neutral task/contrast was done by applying linear mixed effects models testing the effect of treatment-time on connectivity. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.83
73882154|NCT00525512|147298384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.11|0.198||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.198|0.110|<0.0001
74061133|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.539|||<|0.0001|TWO_SIDED|95.0|4.407|4.671|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||4.671|4.407|<.0001
74061134|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.415|||<|0.0001|TWO_SIDED|95.0|4.295|4.534|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||4.534|4.295|<.0001
74061135|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.431|||<|0.0001|TWO_SIDED|95.0|4.302|4.56|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||4.560|4.302|<.0001
74061136|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.361|||<|0.0001|TWO_SIDED|95.0|4.243|4.48|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||4.480|4.243|<.0001
74061137|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.486|||<|0.0001|TWO_SIDED|95.0|4.359|4.612|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||4.612|4.359|<.0001
74061138|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.588|||<|0.0001|TWO_SIDED|95.0|4.473|4.703|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||4.703|4.473|<.0001
74061139|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.259||||0.0073|TWO_SIDED|95.0|-0.469|-0.049|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.049|-0.469|0.0073
74061140|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.246||||0.0041|TWO_SIDED|95.0|-0.438|-0.055|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.055|-0.438|0.0041
74061141|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.15||||0.308|TWO_SIDED|95.0|-0.361|0.061|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.061|-0.361|0.3080
73882155|NCT00525512|147298385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.117|0.208||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.208|0.117|<0.0001
73882156|NCT00525512|147298386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.099|0.192||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.192|0.099|<0.0001
74061142|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.152||||0.1982|TWO_SIDED|95.0|-0.343|0.039|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.039|-0.343|0.1982
74102505|NCT04424407|147754182|OTHER||||||<|0.0001||||||P-values are from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in depression symptom severity score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||<0.0001
74102506|NCT04424407|147754183|OTHER|||||||0.002||||||P-values are from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in sleep efficiency was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.002
73882157|NCT00525512|147298387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|||<|0.0001||95.0|0.077|0.176||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.176|0.077|<0.0001
73882158|NCT00525512|147298388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||<|0.0001||95.0|0.083|0.185||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.185|0.083|<0.0001
73882159|NCT00525512|147298389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|||<|0.0001||95.0|0.097|0.202||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.202|0.097|<0.0001
73882160|NCT00525512|147298390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.0001||95.0|0.077|0.183||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.183|0.077|<0.0001
73882161|NCT00525512|147298391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|||<|0.0001||95.0|0.127|0.307||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.307|0.127|<0.0001
73882162|NCT00525512|147298392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157||||0.0019||95.0|0.058|0.255||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.255|0.058|0.0019
73882163|NCT00525512|147298393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.0006||95.0|0.078|0.286||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.286|0.078|0.0006
73882164|NCT00525512|147298394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|||<|0.0001||95.0|0.13|0.339||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.339|0.130|<0.0001
73882165|NCT00525512|147298395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161||||0.009||95.0|0.04|0.281||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.281|0.040|0.009
73882166|NCT00525512|147298396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212||||0.0002||95.0|0.102|0.322||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.322|0.102|0.0002
73882167|NCT00525512|147298397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|||<|0.0001||95.0|0.128|0.355||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.355|0.128|<0.0001
73882168|NCT00525512|147298398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.277|||<|0.0001||95.0|0.179|0.375||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.375|0.179|<0.0001
73882169|NCT00525512|147298399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.325|||<|0.0001||95.0|0.226|0.425||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.425|0.226|<0.0001
73882170|NCT00525512|147298400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353|||<|0.0001||95.0|0.245|0.461||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.461|0.245|<0.0001
73882171|NCT00525512|147298401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.259|||<|0.0001||95.0|0.154|0.365||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.365|0.154|<0.0001
73882172|NCT00525512|147298402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.0001||95.0|0.194|0.406||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.406|0.194|<0.0001
73882173|NCT00525512|147298403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|||<|0.0001||95.0|0.144|0.364||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.364|0.144|<0.0001
73882174|NCT00525512|147298404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|||<|0.0001||95.0|0.209|0.456||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.456|0.209|<0.0001
73882175|NCT00525512|147298405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.1131||95.0|-0.72|0.08||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.08|-0.72|0.1131
73882176|NCT00525512|147298406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9071||95.0|-0.38|0.33||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.33|-0.38|0.9071
73882177|NCT00525512|147298407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.6878||95.0|-0.35|0.53||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.53|-0.35|0.6878
73882178|NCT00525512|147298408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||||95.0|-2.39|3.11||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.11|-2.39|
74061143|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.725|||<|0.0001|TWO_SIDED|95.0|-0.965|-0.486|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.486|-0.965|<.0001
74061144|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.008|-0.571|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.571|-1.008|<.0001
74061145|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.833|||<|0.0001|TWO_SIDED|95.0|-1.069|-0.597|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.597|-1.069|<.0001
74061146|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.843|||<|0.0001|TWO_SIDED|95.0|-1.059|-0.627|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.627|-1.059|<.0001
74061147|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.52|||<|0.0001|TWO_SIDED|95.0|0.294|0.745|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.745|0.294|<.0001
74061148|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.37|||<|0.0001|TWO_SIDED|95.0|0.163|0.577|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.577|0.163|<.0001
74061149|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.628|||<|0.0001|TWO_SIDED|95.0|0.402|0.855|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.855|0.402|<.0001
74061150|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.464|||<|0.0001|TWO_SIDED|95.0|0.257|0.67|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.670|0.257|<.0001
74102507|NCT04424407|147754184|OTHER||||||<|0.0001||||||P-values are from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in suicidal ideation score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||<0.0001
74061151|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.053||||0.9984|TWO_SIDED|95.0|-0.2|0.306|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.306|-0.200|0.9984
74061152|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.173||||0.2491|TWO_SIDED|95.0|-0.405|0.058|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.058|-0.405|0.2491
74061153|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.054||||0.9977|TWO_SIDED|95.0|-0.304|0.195|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.195|-0.304|0.9977
74061154|NCT03692078|147674423|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.227||||0.0554|TWO_SIDED|95.0|-0.456|0.003|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.003|-0.456|0.0554
74061155|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.294|||<|0.0001|TWO_SIDED|95.0|3.208|3.379|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.379|3.208|<.0001
74061156|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.262|||<|0.0001|TWO_SIDED|95.0|3.176|3.348|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.348|3.176|<.0001
74061157|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.12|||<|0.0001|TWO_SIDED|95.0|3.039|3.202|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||3.202|3.039|<.0001
74061158|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.099|||<|0.0001|TWO_SIDED|95.0|3.017|3.181|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||3.181|3.017|<.0001
74102508|NCT04424407|147754185|OTHER|||||||0.03||||||P-values are uncorrected from ordinal logistic regression model. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|A significant p-value here means that treatment was associated with reduced odds of being in a higher risk category.||Analysis of change in suicidal risk was done by applying ordinal logistic regression (proportional odds model) testing the effect of treatment-time on the probability of being in a higher risk category. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.03
74102509|NCT04424407|147754191|OTHER|||||||0.28|||||||Mixed Models Analysis|||Analysis of change in sleep onset latency (PSG) was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.28
74061159|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.182|||<|0.0001|TWO_SIDED|95.0|3.1|3.264|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||3.264|3.100|<.0001
74061160|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.149|||<|0.0001|TWO_SIDED|95.0|3.066|3.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||3.231|3.066|<.0001
74102510|NCT04424407|147754192|OTHER|||||||0.33||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in number of awakenings derived from PSG was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.33
74102511|NCT04424407|147754193|OTHER|||||||0.013||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in wake after sleep onset (WASO) was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.013
74102512|NCT04424407|147754194|OTHER|||||||0.66||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG TST was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.66
74102513|NCT04424407|147754195|OTHER|||||||0.96||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Delta absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.96
74102514|NCT04424407|147754195|OTHER|||||||0.23||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Theta absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.23
74102515|NCT04424407|147754195|OTHER|||||||0.11||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Alpha absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.11
74102516|NCT04424407|147754195|OTHER|||||||0.44||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Sigma absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.44
74102517|NCT04424407|147754195|OTHER|||||||0.68||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Beta-1 absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.68
74102518|NCT04424407|147754195|OTHER|||||||0.74||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Beta-2 absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.74
74102519|NCT04424407|147754195|OTHER|||||||0.84||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in PSG Gamma absolute power was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.84
73882179|NCT00525512|147298409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||||95.0|-2.66|3.31||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.31|-2.66|
74061161|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.777|||<|0.0001|TWO_SIDED|95.0|2.673|2.881|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||2.881|2.673|<.0001
74061162|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.651|||<|0.0001|TWO_SIDED|95.0|2.546|2.756|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||2.756|2.546|<.0001
74061163|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.72|||<|0.0001|TWO_SIDED|95.0|2.618|2.823|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.823|2.618|<.0001
74061164|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.649|||<|0.0001|TWO_SIDED|95.0|2.544|2.753|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||2.753|2.544|<.0001
74061165|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.751|||<|0.0001|TWO_SIDED|95.0|2.651|2.851|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||2.851|2.651|<.0001
74061166|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.819|||<|0.0001|TWO_SIDED|95.0|2.718|2.919|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||2.919|2.718|<.0001
73882180|NCT00525512|147298410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||||95.0|-2.91|3.58||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.58|-2.91|
73882181|NCT00525512|147298411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||||95.0|-2.97|3.43||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.43|-2.97|
73882182|NCT00525512|147298412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||||95.0|-3.02|3.46||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.46|-3.02|
74061167|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.173||||0.0377|TWO_SIDED|95.0|-0.34|-0.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.006|-0.340|0.0377
74102520|NCT04424407|147754196|OTHER||||||<|0.0001||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in insomnia symptom severity score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||<0.0001
74102521|NCT04424407|147754197|OTHER||||||<|0.0001||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in SF-36 Mental Component Score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||<0.0001
73882183|NCT00525512|147298413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||||95.0|-3.1|3.41||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.41|-3.10|
73882184|NCT00525512|147298414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||||95.0|-3.22|3.55||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.55|-3.22|
73882185|NCT00525512|147298415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||||95.0|-2.78|3.52||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.52|-2.78|
73882186|NCT00525512|147298416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||||95.0|-3.05|3.51||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.51|-3.05|
73882187|NCT00525512|147298417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||||95.0|-3.4|3.55||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.55|-3.40|
73882188|NCT00525512|147298418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||||95.0|-3.61|3.92||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.92|-3.61|
73882189|NCT00525512|147298419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||||95.0|-3.53|3.9||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.90|-3.53|
73882190|NCT00525512|147298420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||||95.0|-3.36|3.71||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.71|-3.36|
74102522|NCT04424407|147754197|OTHER|||||||0.94||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in SF-36 Physical Component Score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||0.94
73882191|NCT00525512|147298421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||||95.0|-3.82|3.96||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.96|-3.82|
73882192|NCT00525512|147298422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03||||0.0072||95.0|-6.97|-1.1||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-1.10|-6.97|0.0072
73882193|NCT00525512|147298423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.2029||95.0|-5.91|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.26|-5.91|0.2029
73882194|NCT00525512|147298424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.0313||95.0|-6.84|-0.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-0.32|-6.84|0.0313
73882195|NCT00525512|147298425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.94||||0.0001||95.0|-13.37|-4.52||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-4.52|-13.37|0.0001
73882196|NCT00525512|147298426|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.94||||0.6541||95.0|0.719|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Regression, Cox|||||1.230|0.719|0.6541
73882197|NCT00525512|147298427|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.06||||0.4443||95.0|0.91|1.25||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||1.25|0.91|0.4443
73882198|NCT00525512|147298428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.8644||95.0|-0.05|0.06||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.06|-0.05|0.8644
73882199|NCT00525512|147298429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.4277||95.0|-0.07|0.17||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.17|-0.07|0.4277
73882200|NCT00525512|147298430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.7071||95.0|-3.81|2.59||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||2.59|-3.81|0.7071
73882201|NCT00525512|147298431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.6556||95.0|-3.03|4.81||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||4.81|-3.03|0.6556
73882202|NCT00525512|147298432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.9896||95.0|-3.44|3.48||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||3.48|-3.44|0.9896
73882203|NCT00525512|147298433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33||||0.0807||95.0|-9.19|0.53||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.53|-9.19|0.0807
73882204|NCT02588599|147298451|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|t=8.0; df=53||||||<0.0001
73882205|NCT00395746|147298459|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.27|||<|0.0001||95.0|-1.51|1.02||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."||1.02|-1.51|<0.0001
73882206|NCT00395746|147298459|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.0|||<|0.0001||95.0|-1.24|-0.75|||ANOVA|A significance level of a two-sided 5% was used for statistical hypothesis testing.||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."||-0.75|-1.24|<0.0001
73882207|NCT00395746|147298460|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.33||||||95.0|-1.62|-1.04|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.04|-1.62|
74061168|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.163||||0.0643|TWO_SIDED|95.0|-0.331|0.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.006|-0.331|0.0643
74102523|NCT04424407|147754198|OTHER||||||<|0.0001||||||P-values are uncorrected from linear mixed effects models. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analysis of change in anxiety symptom severity score was done by applying linear mixed effects models testing the effect of treatment-time. Random intercepts at the individual participant level are included to account for the clustering of observations within individuals across time. All statistical models include age and sex as covariates of non-interest.||||<0.0001
74102524|NCT02362594|147754200|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|98.4|0.43|0.74||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.||0.74|0.43|<0.0001
74061169|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.112||||0.3875|TWO_SIDED|95.0|-0.279|0.056|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.056|-0.279|0.3875
74061170|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.113||||0.3725|TWO_SIDED|95.0|-0.28|0.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.054|-0.280|0.3725
74061171|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.516|||<|0.0001|TWO_SIDED|95.0|-0.706|-0.327|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.327|-0.706|<.0001
74061172|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.611|||<|0.0001|TWO_SIDED|95.0|-0.802|-0.42|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.420|-0.802|<.0001
74061173|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.573|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.386|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.386|-0.760|<.0001
74102525|NCT02362594|147754201|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.42|0.69||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms (PD-L1-positive participants) was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.||0.69|0.42|<0.0001
74102526|NCT03499964|147754221|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||||||<0.0001
74102527|NCT03499964|147754223|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
74102528|NCT03651700|147754323|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74102529|NCT03651700|147754324|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74102530|NCT04916730|147754332|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74061174|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.803|-0.423|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.423|-0.803|<.0001
74061175|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.369|||<|0.0001|TWO_SIDED|95.0|0.19|0.548|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.548|0.190|<.0001
74061176|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.28||||0.0003|TWO_SIDED|95.0|0.099|0.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.462|0.099|0.0003
74061177|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.431|||<|0.0001|TWO_SIDED|95.0|0.251|0.611|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.611|0.251|<.0001
74061178|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.33|||<|0.0001|TWO_SIDED|95.0|0.149|0.511|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.511|0.149|<.0001
74061179|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.026||||1|TWO_SIDED|95.0|-0.176|0.228|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.228|-0.176|1.0000
74061180|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.168||||0.1589|TWO_SIDED|95.0|-0.371|0.036|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.036|-0.371|0.1589
74061181|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.031||||0.9999|TWO_SIDED|95.0|-0.23|0.168|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.168|-0.230|0.9999
74061182|NCT03692078|147674425|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.17||||0.1453|TWO_SIDED|95.0|-0.372|0.032|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.032|-0.372|0.1453
74102531|NCT05479734|147754344|SUPERIORITY|Expected Outcomes: greater number of activities while receiving parenting tips.|||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. An intervention effect difference by sequence is reported when significant.||Null hypothesis is the number of positive activities engaged in with the child will not differ during the periods with and without app-delivered parenting tips. Mixed effects models were performed regressing mean activity counts on a 'Tips Active' indicator and a measurement-period (1st two weeks vs last two weeks) indicator.||||<0.01
74102532|NCT05479734|147754345|SUPERIORITY||||||<|1||||||Test was performed with a significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. A randomization group difference over time is reported if significant.||Null hypothesis is that the mean positive parenting subscale score would not change from the baseline to the post-intervention assessment. Mixed effects models were performed regressing mean subscale scores on a timeframe (baseline vs post) indicator and a randomization group (early vs late app-delivered parenting tips) indicator. A randomization group difference over time was evaluated. This interaction effect was not included in the final statistical model unless statistically significant.||||<1.00
74061183|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.085|||<|0.0001|TWO_SIDED|95.0|0.788|1.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.382|0.788|<.0001
74061184|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.104|||<|0.0001|TWO_SIDED|95.0|0.807|1.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.400|0.807|<.0001
74061185|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.606|||<|0.0001|TWO_SIDED|95.0|0.326|0.886|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||0.886|0.326|<.0001
74061186|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.476||||0.0011|TWO_SIDED|95.0|0.192|0.76|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||0.760|0.192|0.0011
74061187|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.505||||0.0006|TWO_SIDED|95.0|0.219|0.79|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||0.790|0.219|0.0006
73882208|NCT00395746|147298460|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.96||||||95.0|-1.25|-0.67|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-0.67|-1.25|
73882209|NCT00395746|147298461|SUPERIORITY_OR_OTHER||Least Squares Mean|-32.4|||<|0.0001||95.0|-40.5|-24.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.||-24.2|-40.5|<0.0001
73882210|NCT00395746|147298461|SUPERIORITY_OR_OTHER||Least Squares Mean|-26.4|||<|0.0001||95.0|-34.5|-18.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.||-18.2|-34.5|<0.0001
73882211|NCT00395746|147298462|SUPERIORITY_OR_OTHER||Least Squares Mean|-30.2||||||95.0|-39.6|-20.7|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-20.7|-39.6|
73882212|NCT00395746|147298462|SUPERIORITY_OR_OTHER||Least Squares Mean|-24.4||||||95.0|-33.8|-14.9|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-14.9|-33.8|
73882213|NCT00395746|147298463|SUPERIORITY_OR_OTHER||Least Squares Mean|-150.22|||<|0.0001||95.0|-186.32|-114.12||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-114.12|-186.32|<0.0001
73882214|NCT00395746|147298463|SUPERIORITY_OR_OTHER||Least Squares Mean|-111.15|||<|0.0001||95.0|-147.61|-74.68||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-74.68|-147.61|<0.0001
73882215|NCT00395746|147298464|SUPERIORITY_OR_OTHER||Least Squares Mean|-127.57||||||95.0|-166.91|-88.24|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-88.24|-166.91|
73882216|NCT00395746|147298464|SUPERIORITY_OR_OTHER||Least Squares Mean|-68.68||||||95.0|-108.91|-28.45|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-28.45|-108.91|
73882217|NCT00395746|147298465|SUPERIORITY_OR_OTHER||Least Squares Mean|-44.45|||<|0.0001||95.0|-55.02|-33.89||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-33.89|-55.02|<0.0001
73882218|NCT00395746|147298465|SUPERIORITY_OR_OTHER||Least Squares Mean|-34.3|||<|0.0001||95.0|-45.06|-23.54||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-23.54|-45.06|<0.0001
73882219|NCT00395746|147298466|SUPERIORITY_OR_OTHER||Least Squares Mean|-34.49||||||95.0|-46.77|-22.22|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-22.22|-46.77|
74061188|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.775|||<|0.0001|TWO_SIDED|95.0|0.49|1.06|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.060|0.490|<.0001
74061189|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.116|||<|0.0001|TWO_SIDED|95.0|-2.472|-1.761|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.761|-2.472|<.0001
74061190|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.016|||<|0.0001|TWO_SIDED|95.0|-2.376|-1.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-1.656|-2.376|<.0001
74061191|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.605|||<|0.0001|TWO_SIDED|95.0|-1.958|-1.253|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-1.253|-1.958|<.0001
74061192|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.642|||<|0.0001|TWO_SIDED|95.0|-2.003|-1.282|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-1.282|-2.003|<.0001
74061193|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.578|||<|0.0001|TWO_SIDED|95.0|-1.922|-1.234|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-1.234|-1.922|<.0001
74061194|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.726|||<|0.0001|TWO_SIDED|95.0|-2.074|-1.378|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-1.378|-2.074|<.0001
74061195|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.479||||0.1579|TWO_SIDED|95.0|-1.054|0.097|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.097|-1.054|0.1579
74061196|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.628||||0.026|TWO_SIDED|95.0|-1.207|-0.048|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.048|-1.207|0.0260
74061197|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.58||||0.0483|TWO_SIDED|95.0|-1.158|-0.003|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.003|-1.158|0.0483
74061198|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.329||||0.5842|TWO_SIDED|95.0|-0.906|0.249|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.249|-0.906|0.5842
74061199|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-3.201|||<|0.0001|TWO_SIDED|95.0|-3.856|-2.546|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.546|-3.856|<.0001
74061200|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.119|||<|0.0001|TWO_SIDED|95.0|-3.779|-2.46|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.460|-3.779|<.0001
74061201|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.69|||<|0.0001|TWO_SIDED|95.0|-3.338|-2.043|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.043|-3.338|<.0001
74061202|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.746|||<|0.0001|TWO_SIDED|95.0|-3.402|-2.09|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.090|-3.402|<.0001
74061203|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.184|||<|0.0001|TWO_SIDED|95.0|1.565|2.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.803|1.565|<.0001
74061204|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.202|||<|0.0001|TWO_SIDED|95.0|1.576|2.828|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.828|1.576|<.0001
74102533|NCT05479734|147754346|SUPERIORITY||||||<|0.14||||||Test was performed with a significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. An intervention effect difference by sequence is reported when significant.||Null hypothesis is that the number of hours spent with the child will not differ during the periods with and without app-delivered parenting tips. Mixed effects models were performed regressing mean number of hours on a 'Tips Active' indicator and a measurement-period (1st two weeks vs last two weeks) indicator.||||<0.14
74061205|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.083|||<|0.0001|TWO_SIDED|95.0|1.461|2.704|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.704|1.461|<.0001
74061206|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.501|||<|0.0001|TWO_SIDED|95.0|1.876|3.126|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||3.126|1.876|<.0001
74061207|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.538||||0.2085|TWO_SIDED|95.0|-1.231|0.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.154|-1.231|0.2085
74061208|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.289||||0.8557|TWO_SIDED|95.0|-0.988|0.41|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.410|-0.988|0.8557
74061209|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.027||||1|TWO_SIDED|95.0|-0.713|0.658|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.658|-0.713|1.0000
74061210|NCT03692078|147674427|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.084||||1|TWO_SIDED|95.0|-0.612|0.78|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.780|-0.612|1.0000
74061211|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.081|||<|0.0001|TWO_SIDED|95.0|0.679|1.484|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.484|0.679|<.0001
74061212|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.309|||<|0.0001|TWO_SIDED|95.0|0.902|1.716|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.716|0.902|<.0001
74061213|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.996|||<|0.0001|TWO_SIDED|95.0|0.615|1.377|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.377|0.615|<.0001
74061214|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.728||||0.0003|TWO_SIDED|95.0|0.339|1.116|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.116|0.339|0.0003
73882220|NCT00395746|147298466|SUPERIORITY_OR_OTHER||Least Squares Mean|-46.34||||||95.0|-58.49|-34.18|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-34.18|-58.49|
73882221|NCT00395746|147298467|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.37||||0.0433||95.0|-22.4|-0.34||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-0.34|-22.40|0.0433
73882222|NCT00395746|147298467|SUPERIORITY_OR_OTHER||Least Squares Mean|6.67||||0.2359||95.0|-4.39|17.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||17.73|-4.39|0.2359
73882223|NCT00395746|147298468|SUPERIORITY_OR_OTHER||Least Squares Mean|-13.3||||||95.0|-24.69|-1.9|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.90|-24.69|
73882224|NCT00395746|147298468|SUPERIORITY_OR_OTHER||Least Squares Mean|-7.11||||||95.0|-18.42|4.21|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||4.21|-18.42|
73882225|NCT00395746|147298469|SUPERIORITY_OR_OTHER||Least Squares Mean|0.75||||0.0071||95.0|0.21|1.3||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||1.30|0.21|0.0071
74061215|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.987|||<|0.0001|TWO_SIDED|95.0|0.593|1.381|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.381|0.593|<.0001
74061216|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.865|||<|0.0001|TWO_SIDED|95.0|0.475|1.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.254|0.475|<.0001
73882226|NCT00395746|147298469|SUPERIORITY_OR_OTHER||Least Squares Mean|1.18|||<|0.0001||95.0|0.63|1.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||1.73|0.63|<0.0001
73882227|NCT00395746|147298470|SUPERIORITY_OR_OTHER||Least Squares Mean|1.04||||||95.0|0.42|1.66|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||1.66|0.42|
74061217|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.436||||0.0768|TWO_SIDED|95.0|-0.047|0.92|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||0.920|-0.047|0.0768
74061218|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.091||||0.7155|TWO_SIDED|95.0|-0.4|0.583|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.583|-0.400|0.7155
74061219|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.237||||0.3282|TWO_SIDED|95.0|-0.239|0.713|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.713|-0.239|0.3282
74061220|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.23||||0.3578|TWO_SIDED|95.0|-0.722|0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.262|-0.722|0.3578
74061221|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.338||||0.1638|TWO_SIDED|95.0|-0.138|0.814|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.814|-0.138|0.1638
74061222|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.05||||0.8384|TWO_SIDED|95.0|-0.533|0.433|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||0.433|-0.533|0.8384
74061223|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.086||||1|TWO_SIDED|95.0|-0.869|0.698|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.698|-0.869|1.0000
74061224|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.581||||0.2808|TWO_SIDED|95.0|-1.377|0.214|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.214|-1.377|0.2808
74102534|NCT05479734|147754347|OTHER|The model tested the significance of a non-zero location of the data. Effects significantly greater than zero reflect endorsement of app helpfulness.|||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis was that the app was only slightly helpful (scored 0). A Wilcoxon signed rank test was first performed to evaluate potential differences across randomization groups (early vs late app-delivered parenting tips). When the test of a randomization group difference was not significant, the analysis continued with a one-sample Wilcoxon signed rank test.||||<0.01
74061225|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.095||||1|TWO_SIDED|95.0|-0.887|0.698|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.698|-0.887|1.0000
74061226|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.444||||0.6018|TWO_SIDED|95.0|-1.237|0.349|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.349|-1.237|0.6018
74061227|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.645||||0.2935|TWO_SIDED|95.0|-1.536|0.246|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||0.246|-1.536|0.2935
74061228|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.218||||0.0023|TWO_SIDED|95.0|-2.12|-0.315|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.315|-2.120|0.0023
74061229|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.844||||0.0669|TWO_SIDED|95.0|-1.723|0.035|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||0.035|-1.723|0.0669
74061230|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.539|||<|0.0001|TWO_SIDED|95.0|-2.438|-0.64|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.640|-2.438|<.0001
74061231|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.658||||0.212|TWO_SIDED|95.0|-0.192|1.509|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.509|-0.192|0.2120
74061232|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.778||||0.0993|TWO_SIDED|95.0|-0.087|1.642|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.642|-0.087|0.0993
74102535|NCT05479734|147754348|OTHER|The model tested the significance of a non-zero location of the data. Effects significantly greater than zero reflect endorsement of future app use.|||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there would only be slight interest (scored 0) in using the app in the future. A Wilcoxon signed rank test was, first, performed to evaluate potential differences across randomization groups (early vs late app-delivered parenting tips). When the test of a randomization group difference was not significant, the analysis continued with a one-sample Wilcoxon signed rank test.||||<0.01
74061233|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.649||||0.2347|TWO_SIDED|95.0|-0.211|1.509|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.509|-0.211|0.2347
74061234|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.915||||0.032|TWO_SIDED|95.0|0.052|1.778|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.778|0.052|0.0320
74061235|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.099||||1|TWO_SIDED|95.0|-0.849|1.047|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||1.047|-0.849|1.0000
74061236|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.141||||0.9999|TWO_SIDED|95.0|-0.82|1.103|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||1.103|-0.820|0.9999
74061237|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||1|TWO_SIDED|95.0|-1.038|0.837|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.837|-1.038|1.0000
74061238|NCT03692078|147674429|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.18||||0.9995|TWO_SIDED|95.0|-1.139|0.779|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.779|-1.139|0.9995
74061239|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.12|||<|0.0001|TWO_SIDED|95.0|2.964|3.276|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.276|2.964|<.0001
74061240|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.141|||<|0.0001|TWO_SIDED|95.0|2.953|3.328|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.328|2.953|<.0001
74061241|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.658|||<|0.0001|TWO_SIDED|95.0|2.511|2.806|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.806|2.511|<.0001
73888234|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.42|-0.74|<0.0001
74061242|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.638|||<|0.0001|TWO_SIDED|95.0|2.458|2.817|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.817|2.458|<.0001
74061243|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.754|||<|0.0001|TWO_SIDED|95.0|2.604|2.903|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.903|2.604|<.0001
74061244|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.652|||<|0.0001|TWO_SIDED|95.0|2.471|2.832|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.832|2.471|<.0001
74061245|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.703|||<|0.0001|TWO_SIDED|95.0|1.517|1.889|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.889|1.517|<.0001
74061246|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.637|||<|0.0001|TWO_SIDED|95.0|1.41|1.865|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.865|1.410|<.0001
74061247|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.656|||<|0.0001|TWO_SIDED|95.0|1.472|1.839|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||1.839|1.472|<.0001
74061248|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.485|||<|0.0001|TWO_SIDED|95.0|1.259|1.711|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.711|1.259|<.0001
74061249|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.713|||<|0.0001|TWO_SIDED|95.0|1.532|1.895|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||1.895|1.532|<.0001
73888235|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.92|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.92|-1.25|<0.0001
74061250|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.617|||<|0.0001|TWO_SIDED|95.0|1.397|1.837|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.837|1.397|<.0001
74061251|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.462||||0.0003|TWO_SIDED|95.0|-0.766|-0.158|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.158|-0.766|0.0003
74061252|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.503||||0.0018|TWO_SIDED|95.0|-0.867|-0.139|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.139|-0.867|0.0018
74061253|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.366||||0.0089|TWO_SIDED|95.0|-0.67|-0.062|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.062|-0.670|0.0089
74061254|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.489||||0.0025|TWO_SIDED|95.0|-0.851|-0.126|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.126|-0.851|0.0025
74061255|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.417|||<|0.0001|TWO_SIDED|95.0|-1.762|-1.072|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.072|-1.762|<.0001
74061256|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.504|||<|0.0001|TWO_SIDED|95.0|-1.916|-1.091|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.091|-1.916|<.0001
74061257|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.464|||<|0.0001|TWO_SIDED|95.0|-1.804|-1.125|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.125|-1.804|<.0001
74061258|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.656|||<|0.0001|TWO_SIDED|95.0|-2.065|-1.247|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.247|-2.065|<.0001
74061259|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.945|||<|0.0001|TWO_SIDED|95.0|0.617|1.273|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.273|0.617|<.0001
73882228|NCT00395746|147298470|SUPERIORITY_OR_OTHER||Least Squares Mean|1.13||||||95.0|0.51|1.75|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed||1.75|0.51|
74061260|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.021|||<|0.0001|TWO_SIDED|95.0|0.628|1.413|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.413|0.628|<.0001
74061261|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.041|||<|0.0001|TWO_SIDED|95.0|0.712|1.369|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.369|0.712|<.0001
74061262|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.035|||<|0.0001|TWO_SIDED|95.0|0.644|1.426|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.426|0.644|<.0001
74061263|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.01||||1|TWO_SIDED|95.0|-0.376|0.355|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.355|-0.376|1.0000
74061264|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.02||||1|TWO_SIDED|95.0|-0.417|0.457|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.457|-0.417|1.0000
74061265|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.058||||0.9999|TWO_SIDED|95.0|-0.418|0.303|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.303|-0.418|0.9999
74061266|NCT03692078|147674431|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.132||||0.9669|TWO_SIDED|95.0|-0.566|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.301|-0.566|0.9669
74102536|NCT05479734|147754349|OTHER|The model tested the significance of a non-zero location of the data. Effects significantly greater than zero reflect a desire to recommend the app.|||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis was that the participant was neither likely nor unlikely (scored 0) to recommend the app to friends. A Wilcoxon signed rank test was, first, performed to evaluate potential differences across randomization groups (early vs late app-delivered parenting tips). When the test of a randomization group difference was not significant, the analysis continued with a one-sample Wilcoxon signed rank test.||||<0.01
73882229|NCT00395746|147298471|SUPERIORITY_OR_OTHER||Rate ratio|1.59||||||95.0|0.86|2.96|||Negative binomial regression|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.96|0.86|
73888236|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.59|-0.26|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.26|-0.59|<0.0001
74061267|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.442|||<|0.0001|TWO_SIDED|95.0|-1.604|-1.279|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||-1.279|-1.604|<.0001
74061268|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.413|||<|0.0001|TWO_SIDED|95.0|-1.576|-1.251|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||-1.251|-1.576|<.0001
74061269|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.754|||<|0.0001|TWO_SIDED|95.0|-1.907|-1.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||-1.600|-1.907|<.0001
74061270|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.816|||<|0.0001|TWO_SIDED|95.0|-1.972|-1.659|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||-1.659|-1.972|<.0001
74061271|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.654|||<|0.0001|TWO_SIDED|95.0|-1.81|-1.498|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||-1.498|-1.810|<.0001
74061272|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.829|||<|0.0001|TWO_SIDED|95.0|-1.986|-1.673|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||-1.673|-1.986|<.0001
74061273|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.184|||<|0.0001|TWO_SIDED|95.0|-2.379|-1.989|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.989|-2.379|<.0001
74061274|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.27|||<|0.0001|TWO_SIDED|95.0|-2.468|-2.071|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-2.071|-2.468|<.0001
74102537|NCT05479734|147754350|SUPERIORITY||||||<|0.54||||||Test performed with significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. A randomization group difference over time is reported if significant.||Null hypothesis is that the mean general development scale score would not change from the baseline to the post-intervention assessment. Mixed effects models were performed regressing mean scale scores on a timeframe (baseline vs post) indicator and a randomization group (early vs late app-delivered parenting tips) indicator.||||<0.54
74061275|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.413|||<|0.0001|TWO_SIDED|95.0|-2.607|-2.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-2.219|-2.607|<.0001
74061276|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.349|||<|0.0001|TWO_SIDED|95.0|-2.549|-2.149|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-2.149|-2.549|<.0001
74061277|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.227|||<|0.0001|TWO_SIDED|95.0|-2.416|-2.038|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-2.038|-2.416|<.0001
74061278|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.154|||<|0.0001|TWO_SIDED|95.0|-2.345|-1.962|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-1.962|-2.345|<.0001
74061279|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.312||||0.0552|TWO_SIDED|95.0|-0.628|0.004|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.004|-0.628|0.0552
74102538|NCT05479734|147754351|SUPERIORITY||||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. An intervention effect difference by sequence is reported if significant.||Null hypothesis is that the number of challenging child behaviors will not differ during the periods with and without app-delivered parenting tips. Mixed effects models were performed regressing mean behavior counts on a 'Tips Active' indicator and a measurement-period (1st two weeks vs last two weeks) indicator.||||<0.01
74102539|NCT05479734|147754352|SUPERIORITY|Expected Outcomes: greater number of behaviors while receiving parenting tips.|||||<|0.01||||||Test performed with significance level of 0.05 (two-sided).|Mixed Models Analysis|The model coefficient t-test uses Satterthwaite's degrees of freedom. An intervention effect difference by sequence is reported if significant.||Null hypothesis is that the daily number of positive child behaviors will not differ during the periods with and without app-delivered parenting tips. Mixed effects models were performed regressing mean behavior counts on a 'Tips Active' indicator and a measurement-period (1st two weeks vs last two weeks) indicator.||||<0.01
74102540|NCT03083665|147754423|SUPERIORITY||Percent reduction over Placebo|24.5||||0.0005|TWO_SIDED|95.0|11.7|35.5||Statistical testing with control of Type I error rate were based on a Hochberg multiple comparison procedure.|ANCOVA||Based on ANCOVA with log-transformed \[log(x+1)\] Treatment Period 28-day adjusted partial seizure frequency.|||35.5|11.7|0.0005
74102541|NCT03083665|147754423|SUPERIORITY||Percent reduction over Placebo|33.4|||<|0.0001|TWO_SIDED|95.0|21.9|43.1||Statistical testing with control of Type I error rate were based on a Hochberg multiple comparison procedure.|ANCOVA||Based on ANCOVA with log-transformed \[log(x+1)\] Treatment Period 28-day adjusted partial seizure frequency.|||43.1|21.9|<0.0001
74102542|NCT00980954|147754454|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.56|TWO_SIDED|90.0|0.65|1.68||One-sided significance level = 0.05.|Log Rank||Reference level = Arm I|Sample size calculations are based on the primary hypothesis that 4 additional cycles of carboplatin and paclitaxel following concurrent radiation and weekly cisplatin will increase 4-year DFS from 80% to 90% for patients with cervical carcinoma with positive nodes and/or positive margins after a radical hysterectomy. One-sided alpha=0.05, statistical power=80%, 5.5 years of accrual with 4 years of follow-up, 2 interim significance tests. 50 DFS events are required to trigger this analysis.||1.68|0.65|0.56
74061280|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.402||||0.0055|TWO_SIDED|95.0|-0.722|-0.083|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.083|-0.722|0.0055
74061281|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.212||||0.3834|TWO_SIDED|95.0|-0.53|0.105|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.105|-0.530|0.3834
74061282|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.416||||0.0033|TWO_SIDED|95.0|-0.734|-0.099|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.099|-0.734|0.0033
73882230|NCT00395746|147298471|SUPERIORITY_OR_OTHER||Rate ratio|1.18||||||95.0|0.56|2.47|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.47|0.56|
74102543|NCT00980954|147754455|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.4|TWO_SIDED|90.0|0.49|1.69||One-sided significance level = 0.05.|Log Rank|||The 4-year overall survival rate for the control arm is expected to be approximately 85%. The overall survival will be compared between the two arms. The final targeted sample size of 235 patients with the longer accrual time, will provide 64% and 78% power to detect an increase in overall survival to 92% and 93% respectively, with a 1- sided alpha of 0.05.||1.69|0.49|0.40
74102544|NCT05630547|147754502|SUPERIORITY||LS Geometric Mean Ratio to Baseline|0.986||||0.8042|TWO_SIDED|95.0|0.881|1.103|||MMRM|||Analysis was performed using mixed-effect model with repeated measures (MMRM) including the fixed categorical effects of the treatment group, multiple sclerosis (MS) clinical subtype (relapsing remitting multiple sclerosis \[RRMS\], secondary progressive multiple sclerosis \[SPMS\], or primary progressive multiple sclerosis \[PPMS\]), visit, treatment-by-visit interaction, log-transformed baseline sNfL levels and log-transformed baseline sNfL levels-by-visit interaction.||1.103|0.881|0.8042
74102545|NCT04428151|147754535|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.9963|TWO_SIDED|95.0|1.11|1.97||One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||1.97|1.11|0.9963
74102546|NCT04428151|147754536|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.4181|TWO_SIDED|95.0|0.74|1.28||One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||1.28|0.74|0.4181
74102547|NCT04428151|147754537|SUPERIORITY||Difference in Percentage|-6.5||||0.9266219|TWO_SIDED|95.0|-15.4|2.3|||Miettinen & Nurminen|One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0. The reported p-value is nominal.|Based on Miettinen \& Nurminen method stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||2.3|-15.4|0.9266219
74102548|NCT00977470|147754542|EQUIVALENCE|All enrolled patients will be included in the intent-to-treat efficacy analyses. Based on historical patients with EGFR mutations treated with gefitinib, we expect median progression-free survival on the erlotinib-alone arm to be approximately 9 months. This trial can detect a difference in proportions alive without progression at 9 months from 50% in the erlotinib arm to 77% in the erlotinib plus HCQ arm, using an alpha of 0.15 and power of 85%, using the two-sided Likelihood Ratio test.||||||0.28|||||||Log Rank|||||||0.28
74102549|NCT05065502|147754558|SUPERIORITY||Mean Difference (Net)|-0.261|STANDARD_ERROR_OF_MEAN|0.238||0.273|TWO_SIDED|95.0|-0.728|0.206||Significance level is set at 0.05.|Regression, Linear||Between-arm difference at 13-18 months post-baseline, controlling for rates 1-6 months pre-baseline|Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs of post-intervention period (months 13 to 18), controlling for use in pre-baseline period (months 0 to 6), averaged across three studies.||0.206|-0.728|0.273
74102550|NCT05065502|147754559|SUPERIORITY||Mean Difference (Net)|0.00138|||||TWO_SIDED|95.0|-0.0245|0.0272||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).||0.0272|-0.0245|
73882231|NCT00395746|147298471|SUPERIORITY_OR_OTHER||Rate ratio|1.8||||||95.0|0.92|3.54|||Negative binomial regression model|||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.54|0.92|
73882232|NCT00395746|147298471|SUPERIORITY_OR_OTHER||Rate ratio|1.62||||||95.0|0.85|3.07|||Negative binomial regression model|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.07|0.85|
74061283|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.743|||<|0.0001|TWO_SIDED|95.0|-1.103|-0.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.382|-1.103|<.0001
74061284|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.857|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.493|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.493|-1.220|<.0001
74061285|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.971|||<|0.0001|TWO_SIDED|95.0|-1.327|-0.616|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.616|-1.327|<.0001
74061286|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.936|||<|0.0001|TWO_SIDED|95.0|-1.298|-0.574|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.574|-1.298|<.0001
74061287|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.473||||0.0016|TWO_SIDED|95.0|0.133|0.813|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.813|0.133|0.0016
74061288|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.338||||0.0582|TWO_SIDED|95.0|-0.007|0.683|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.683|-0.007|0.0582
74061289|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.573|||<|0.0001|TWO_SIDED|95.0|0.232|0.914|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.914|0.232|<.0001
74061290|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.324||||0.0745|TWO_SIDED|95.0|-0.02|0.668|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.668|-0.020|0.0745
74061291|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.043||||1|TWO_SIDED|95.0|-0.337|0.422|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.422|-0.337|1.0000
74061292|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.116||||0.9759|TWO_SIDED|95.0|-0.501|0.268|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.268|-0.501|0.9759
74061293|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.186||||0.7128|TWO_SIDED|95.0|-0.565|0.192|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.192|-0.565|0.7128
74061294|NCT03692078|147674433|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.195||||0.6816|TWO_SIDED|95.0|-0.582|0.192|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.192|-0.582|0.6816
74061295|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.948|||<|0.0001|TWO_SIDED|95.0|-1.146|-0.75|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||-0.750|-1.146|<.0001
74061296|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.019|||<|0.0001|TWO_SIDED|95.0|-1.242|-0.796|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||-0.796|-1.242|<.0001
74061297|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.172|||<|0.0001|TWO_SIDED|95.0|-1.358|-0.986|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||-0.986|-1.358|<.0001
74061298|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.196|||<|0.0001|TWO_SIDED|95.0|-1.409|-0.983|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||-0.983|-1.409|<.0001
74061299|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.049|||<|0.0001|TWO_SIDED|95.0|-1.239|-0.859|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||-0.859|-1.239|<.0001
74061300|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.414|-0.986|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||-0.986|-1.414|<.0001
73882233|NCT00395746|147298471|SUPERIORITY_OR_OTHER||Rate ratio|1.48||||||95.0|0.69|3.17|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.17|0.69|
74061301|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.337|||<|0.0001|TWO_SIDED|95.0|-1.574|-1.099|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.099|-1.574|<.0001
74102551|NCT05065502|147754560|SUPERIORITY||Mean Difference (Net)|23.0|||||TWO_SIDED|95.0|-23.3|69.3|||||Statistical Assumptions for Valid Inference of a typical Difference-in-Difference model were not met, Estimate computed from modelling Post-period, and adjusting for Pre-period.|Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in medication costs from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).||69.3|-23.3|
74102552|NCT05065502|147754561|SUPERIORITY||Median Difference (Net)|-0.599|||||TWO_SIDED|95.0|-1.08|-0.122||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in count of medication note reviews from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).|"Medication reviews per 1,000 patients (outcome multiplied by 1,000).~Statistical Assumptions for Valid Inference of a typical Difference-in-Difference model were not met, Estimate computed from modelling Post-period, and adjusting for Pre-period."|-0.122|-1.080|
74102553|NCT05065502|147754562|SUPERIORITY||Mean Difference (Net)|-0.05317|||||TWO_SIDED|95.0|-0.09073|0.01561||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in count of inappropriate use from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18)||0.01561|-0.09073|
74102554|NCT05065502|147754563|SUPERIORITY||Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-1.44|1.2||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).||1.20|-1.44|
74102555|NCT05065502|147754564|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.83|0.42||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of of high-risk DOAC use attributable to chronic kidney disease for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6), ), controlling for the pre-baseline period (months 0 to 6).||0.42|-0.83|
74102556|NCT05065502|147754565|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|-0.08|0.72||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use attributable to weight for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).||0.72|-0.08|
74102557|NCT05065502|147754566|SUPERIORITY||Mean Difference (Net)|-0.18|||||TWO_SIDED|95.0|-0.7|0.33||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use attributable to mis-dosing for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).||0.33|-0.70|
74102558|NCT05065502|147754567|SUPERIORITY||Mean Difference (Net)|0.01007|||||TWO_SIDED|95.0|-0.02415|0.04429||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of CBTI receipt for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6)||0.04429|-0.02415|
74102559|NCT05065502|147754570|SUPERIORITY||Mean Difference (Net)|-0.0837|||||TWO_SIDED|95.0|-0.21014|0.04275||||||Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).||0.04275|-0.21014|
74102560|NCT05065502|147754571|SUPERIORITY||Mean Difference (Net)|0.102|||||TWO_SIDED|95.0|-0.216|0.42||||||||0.420|-0.216|
74102561|NCT05065502|147754572|SUPERIORITY||Mean Difference (Net)|-0.0389|||||TWO_SIDED|95.0|-0.555|0.477||||||||0.477|-0.555|
74102562|NCT05065502|147754573|SUPERIORITY||Mean Difference (Net)|0.101|||||TWO_SIDED|95.0|-0.25|0.452||||||||0.452|-0.250|
74102563|NCT05065502|147754574|SUPERIORITY||Mean Difference (Net)|-0.0428|||||TWO_SIDED|95.0|-0.339|0.254||||||||0.254|-0.339|
74102564|NCT06152224|147754575|EQUIVALENCE|"Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups.~With an allowable difference of 1 point between randomized groups, standard deviation = 3, margin = 4.3, power = 0.8, alpha = 0.05, attrition = 25 percent."|Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|4.0||0.918|TWO_SIDED|||||a priori threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.918
74102565|NCT06152224|147754580|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.801||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.801
74102566|NCT06152224|147754580|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.317||||||a priori threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.317
74102567|NCT06152224|147754581|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline Brink Score: Pressure||||<0.001
74061302|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.345|||<|0.0001|TWO_SIDED|95.0|-1.616|-1.075|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-1.075|-1.616|<.0001
74061303|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.452|||<|0.0001|TWO_SIDED|95.0|-1.685|-1.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-1.219|-1.685|<.0001
74061304|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.339|||<|0.0001|TWO_SIDED|95.0|-1.608|-1.071|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-1.071|-1.608|<.0001
74061305|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.348|||<|0.0001|TWO_SIDED|95.0|-1.577|-1.118|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-1.118|-1.577|<.0001
74061306|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.227|||<|0.0001|TWO_SIDED|95.0|-1.488|-0.966|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.966|-1.488|<.0001
74061307|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.224||||0.5646|TWO_SIDED|95.0|-0.607|0.16|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.160|-0.607|0.5646
74061308|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.177||||0.8765|TWO_SIDED|95.0|-0.609|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.254|-0.609|0.8765
74061309|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||0.9954|TWO_SIDED|95.0|-0.488|0.287|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.287|-0.488|0.9954
74102568|NCT06152224|147754581|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Pressure||||<0.001
74102569|NCT06152224|147754582|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Change from baseline in Brink Score: Vertical Displacement||||<0.001
74061310|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.181||||0.8665|TWO_SIDED|95.0|-0.613|0.252|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.252|-0.613|0.8665
74102570|NCT06152224|147754582|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Vertical Displacement||||<0.001
74102571|NCT06152224|147754583|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Duration Contraction||||<0.001
74102572|NCT06152224|147754583|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Duration Contraction||||<0.001
74102573|NCT06152224|147754593|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.035||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q1. The app was easy to use||||0.035
74102574|NCT06152224|147754593|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.063||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q2. It was easy for me to learn to use the app||||0.063
74102575|NCT06152224|147754593|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.587||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q11. I would use this app again||||0.587
74102576|NCT06152224|147754593|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.107||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q12. Overall, I am satisfied with this app||||0.107
74102577|NCT06152224|147754593|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.486||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q15. The app helped me manage my health effectively||||0.486
74102578|NCT04016558|147754594|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.007|TWO_SIDED||||||ANCOVA|||||||.007
74102579|NCT04016558|147754595|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.006|TWO_SIDED||||||ANCOVA|||||||.006
74102580|NCT04016558|147754596|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.82|TWO_SIDED||||||ANCOVA|||||||0.82
74102581|NCT04016558|147754597|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.01|TWO_SIDED||||||ANCOVA|||||||.01
74102582|NCT04016558|147754598|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4|TWO_SIDED||||||ANCOVA|||||||.40
74102583|NCT04016558|147754600|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.12|TWO_SIDED||||||ANCOVA|||||||.12
74102584|NCT04016558|147754601|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.39|TWO_SIDED||||||ANCOVA|||||||.39
74102585|NCT04016558|147754602|SUPERIORITY||Mean Difference (Final Values)|0.18|||<|0.01|TWO_SIDED||||||ANCOVA|||||||<.01
73882234|NCT00395746|147298471|SUPERIORITY_OR_OTHER||Rate ratio|1.45||||||95.0|0.72|2.91|||Negative binomial regression model|||The relative risk for 'Symptoms only episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.91|0.72|
74061311|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.389||||0.1165|TWO_SIDED|95.0|-0.829|0.052|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||0.052|-0.829|0.1165
74061312|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.326||||0.3896|TWO_SIDED|95.0|-0.821|0.168|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||0.168|-0.821|0.3896
74061313|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.504||||0.0122|TWO_SIDED|95.0|-0.934|-0.074|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.074|-0.934|0.0122
74061314|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.32||||0.3938|TWO_SIDED|95.0|-0.807|0.167|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||0.167|-0.807|0.3938
74102586|NCT02364557|147754603|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.36|TWO_SIDED|70.0|0.71|1.17||One-side significance level = 0.15|Log Rank||Reference level = SOC arm|Assuming an increase in median PFS from 10.5 to 19 months (HR: 0.55), 69 events provide \>90% power to conclude superiority with 1-sided α = 0.15.||1.17|0.71|0.36
74102587|NCT02364557|147754606|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.91|TWO_SIDED|95.0|0.59|1.61||Two-sided significance level = 0.05|Gray's test||Reference level = SOC arm|||1.61|0.59|0.91
74102588|NCT02364557|147754608|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9|TWO_SIDED|95.0|0.54|2.02||Two-sided significance level = 0.05.|Log Rank||Reference level = CTCs Absent|||2.02|0.54|0.90
74102589|NCT04201262|147754633|OTHER||Hazard Ratio (HR)|0.014|||<|0.0001|TWO_SIDED|95.0|0.0|0.103|||Log Rank||HR based on a Cox proportional hazards model, with Firth's adjustment. Confidence interval (CI)= Wald CI or Profile Likelihood CI Limits. HR for ravulizumab compared with placebo presented a 98.6% reduction in risk of relapse, 95% CI (89.7%, 100.0%).|||0.103|0.000|< 0.0001
73882235|NCT03346434|147298481|SUPERIORITY||Percentage difference|23.8|||<|0.0001|TWO_SIDED|95.0|13.27|34.37||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||34.37|13.27|< 0.0001
74102590|NCT04201262|147754635|OTHER|||||||0.0122||||||Proportional Odds p-value|Univariate models|||The test of proportional odds was determined from a score test. The proportional odds was evaluated in univariate models.||||0.0122
74102591|NCT04103892|147754883|SUPERIORITY||Least square (LS) mean difference|-1.26|STANDARD_ERROR_OF_MEAN|1.69||0.46|TWO_SIDED|95.0|-4.6|2.09|||Mixed Models Repeated Measures (MMRM|||||2.09|-4.60|0.46
74102592|NCT04103892|147754884|SUPERIORITY||Least square (LS) mean difference|-5.28|STANDARD_ERROR_OF_MEAN|2.34||0.03|TWO_SIDED|95.0|-9.91|-0.65|||Mixed Models Repeated Measures (MMRM)|||||-0.65|-9.91|0.03
74102593|NCT05097989|147754885|OTHER||Percentage Difference|-17.7||||0.2422|TWO_SIDED|90.0|-37.5|8.3|||ANCOVA|||||8.3|-37.5|0.2422
74102594|NCT05097989|147754885|OTHER||Percentage Difference|-6.0||||0.8701|TWO_SIDED|90.0|-49.3|74.4|||ANCOVA|||||74.4|-49.3|0.8701
74102595|NCT06176768|147754915|SUPERIORITY||Odds Ratio (OR)|3.4||||0.316|TWO_SIDED|95.0|0.3|40.4|||Cochran-Mantel-Haenszel|||||40.4|0.3|0.316
74102596|NCT06176768|147754916|SUPERIORITY||Least square mean difference|-6.77|STANDARD_ERROR_OF_MEAN|4.63||0.175|TWO_SIDED|95.0|-17.15|3.6|||Mixed Model Repeated Measures Analysis|||||3.60|-17.15|0.175
74102597|NCT06176768|147754917|SUPERIORITY||Least square mean difference|-2.36|STANDARD_ERROR_OF_MEAN|2.27||0.311|TWO_SIDED|95.0|-7.06|2.35|||Mixed Model Repeated Measures Analysis|||||2.35|-7.06|0.311
74102598|NCT03006978|147754919|SUPERIORITY||||||<|0.0001|||||||Simple mixed effects linear models|||||||<0.0001
74102599|NCT03006978|147754920|SUPERIORITY||||||<|0.0001|||||||Simple mixed effects linear models|||||||<0.0001
74102600|NCT03006978|147754921|SUPERIORITY||||||<|0.0001|||||||Simple mixed effects linear models|||||||<0.0001
74102601|NCT03006978|147754922|SUPERIORITY||||||<|0.0001|||||||Simple mixed effects linear models|||||||<0.0001
74102602|NCT03006978|147754923|SUPERIORITY||||||<|0.0001|||||||Simple mixed effects linear models|||||||<0.0001
73882236|NCT03346434|147298482|SUPERIORITY||Percentage difference|42.3|||<|0.0001|TWO_SIDED|95.0|29.47|55.16||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||55.16|29.47|< 0.0001
74061315|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.176||||0.8501|TWO_SIDED|95.0|-0.237|0.589|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.589|-0.237|0.8501
74102603|NCT03298451|147754951|SUPERIORITY|||||||0.0035||||||The adjusted alpha levels (0.0398) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|Log Rank|||The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.||||0.0035
74102604|NCT03298451|147754951|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.66|0.92|||Regression, Cox|||The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.||0.92|0.66|
74102605|NCT03298451|147754952|NON_INFERIORITY|Non-interiority for the comparison of arm Durva 1500 mg vs Sora 400 mg is declared if the upper limit of the two-sided alpha adjusted CI for HR is less than the NI margin of 1.08.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.67|0.73|1.03|||Regression, Cox||The 95.67% confidence interval were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.||1.03|0.73|
74102606|NCT03298451|147754952|SUPERIORITY|Superiority was tested sequentially per protocol as non-inferiority was satisfied.||||||0.0674||||||The adjusted alpha levels (0.0433) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|Log Rank|||The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.||||0.0674
74102607|NCT05480943|147754969|OTHER|chi-square tested correlation between CRP and thiamine deficiency.||||||0.6097||||||P\<=0.05 considered significant|Chi-squared|||For the subset of 123 participants with both C-reactive protein level and plasma thiamine levels, we used Chi-Square to test for association between those who were thiamine deficient and had elevated C-reactive protein (CRP) levels. A priori hypothesis was that inflammation would cause thiamine deficiency due to increased metabolic demands.||||0.6097
74061316|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.031||||1|TWO_SIDED|95.0|-0.435|0.496|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.496|-0.435|1.0000
74061317|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.299||||0.2928|TWO_SIDED|95.0|-0.117|0.715|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.715|-0.117|0.2928
74061318|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.027||||1|TWO_SIDED|95.0|-0.439|0.493|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.493|-0.439|1.0000
74102608|NCT03633721|147754971|SUPERIORITY|||||||0.17|||||||ANOVA|||Hypothesis Being Tested in 2 way ANOVA is that the difference in the change from Baseline to the Average of 15 and 60 minutes post baseline while on cannabis Vs. the change while on placebo (i.e. the last row in the outcomes) is greater for HIV+ subjects than for HIV- subjects.||||0.17
73882237|NCT03346434|147298491|SUPERIORITY||Least Square (LS) Mean Difference|-50.4|||<|0.0001|TWO_SIDED|95.0|-62.38|-38.4||Threshold for significance at 0.05 level.|ANCOVA|||||-38.40|-62.38|< 0.0001
73882238|NCT03346434|147298492|SUPERIORITY||LS Mean Difference|-47.1|||<|0.0001|TWO_SIDED|95.0|-59.47|-34.79||Threshold for significance at 0.05 level.|ANCOVA|||||-34.79|-59.47|< 0.0001
73882239|NCT03346434|147298493|SUPERIORITY||Percentage difference|39.2|||<|0.0001|TWO_SIDED|95.0|26.18|52.27||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||52.27|26.18|< 0.0001
73882240|NCT03346434|147298494|SUPERIORITY||Percentage difference|43.3|||<|0.0001|TWO_SIDED|95.0|30.03|56.67||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||56.67|30.03|< 0.0001
73882241|NCT03346434|147298495|SUPERIORITY||Percentage difference|48.5|||<|0.0001|TWO_SIDED|95.0|35.03|62.0||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||62.00|35.03|< 0.0001
74061319|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.011||||1|TWO_SIDED|95.0|-0.453|0.475|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.475|-0.453|1.0000
74061320|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.118||||0.9966|TWO_SIDED|95.0|-0.64|0.403|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.403|-0.640|0.9966
74061321|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.104||||0.9976|TWO_SIDED|95.0|-0.56|0.352|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.352|-0.560|0.9976
74102609|NCT03633721|147754972|SUPERIORITY|||||||0.18|||||||ANOVA|||Hypothesis Being Tested in 2 way ANOVA is that the difference in the change from Baseline to the Average of 15 and 60 minutes post baseline while on cannabis Vs. the change while on placebo (i.e. the last row in the outcomes) is greater for HIV+ subjects than for HIV- subjects.||||0.18
74102610|NCT03633721|147754973|SUPERIORITY|||||||0.72|||||||ANOVA|||Hypothesis Being Tested in 2 way ANOVA is that the difference in the change from Baseline to the Average of 15 and 60 minutes post baseline while on cannabis Vs. the change while on placebo (i.e. the last row in the outcomes) is greater for HIV+ subjects than for HIV- subjects.||||0.72
74102611|NCT02367040|147754976|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.52||||2e-06|TWO_SIDED|95.0|0.393|0.688||1-sided p-value|Log Rank|||At primary completion date||0.688|0.393|0.000002
74061322|NCT03692078|147674435|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.112||||0.9976|TWO_SIDED|95.0|-0.628|0.404|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.404|-0.628|0.9976
74102612|NCT02367040|147754976|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.557||||3e-06|TWO_SIDED|95.0|0.431|0.722||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||0.722|0.431|0.000003
74102613|NCT02367040|147754976|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.643||||0.000199|TWO_SIDED|95.0|0.502|0.823||1-sided p-value|Log Rank|||At final analysis||0.823|0.502|0.000199
74102614|NCT02367040|147754977|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in ORR|32.99|||<|1e-06|TWO_SIDED|95.0|23.95|42.03||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||42.03|23.95|<0.000001
73882242|NCT03346434|147298496|SUPERIORITY||Percentage difference|22.5|||=|0.0001|TWO_SIDED|95.0|12.37|32.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||32.60|12.37|= 0.0001
73882243|NCT03346434|147298497|SUPERIORITY||LS Mean Difference|-24.27|||<|0.0001|TWO_SIDED|95.0|-31.204|-17.329||Threshold for significance at 0.05 level.|ANCOVA|||||-17.329|-31.204|< 0.0001
73882244|NCT03346434|147298498|SUPERIORITY||LS Mean Difference|-9.1|||<|0.0001|TWO_SIDED|95.0|-11.26|-6.89||Threshold for significance at 0.05 level.|ANCOVA|||||-6.89|-11.26|< 0.0001
73882245|NCT03346434|147298499|SUPERIORITY||LS Mean Difference|-38.4|||<|0.0001|TWO_SIDED|95.0|-46.65|-30.21||Threshold for significance at 0.05 level.|ANCOVA|||||-30.21|-46.65|< 0.0001
73882246|NCT03346434|147298500|SUPERIORITY||LS Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|1.093|2.317||Threshold significance was at 0.05 level.|ANCOVA|||||2.317|1.093|< 0.0001
73882247|NCT03346434|147298501|SUPERIORITY||LS Mean Difference|-3.31|||<|0.0001|TWO_SIDED|95.0|-4.029|-2.6||Threshold significance at 0.05 level.|ANCOVA|||||-2.600|-4.029|< 0.0001
73882248|NCT03346434|147298502|SUPERIORITY||LS Mean Difference|-7.8|||<|0.0001|TWO_SIDED|95.0|-9.789|-5.814||Threshold significance at 0.05 level.|ANCOVA|||||-5.814|-9.789|< 0.0001
73882249|NCT03346434|147298503|SUPERIORITY||LS Mean Difference|-7.5|||<|0.0001|TWO_SIDED|95.0|-10.29|-4.75||Threshold significance at 0.05 level.|ANCOVA|||||-4.75|-10.29|< 0.0001
74102615|NCT02367040|147754977|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in ORR|30.67|||<|1e-06|TWO_SIDED|95.0|21.63|39.72||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||39.72|21.63|<0.000001
74102616|NCT02367040|147754978|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in CRR|19.27|||<|1e-06|TWO_SIDED|95.0|11.57|26.96||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||26.96|11.57|<0.000001
73882250|NCT03346434|147298504|SUPERIORITY||LS Mean Difference|-8.96|||<|0.0001|TWO_SIDED|95.0|-11.711|-6.202||Threshold significance at 0.05 level.|ANCOVA|||||-6.202|-11.711|< 0.0001
73882251|NCT03346434|147298505|SUPERIORITY||||||=|0.0015||||||Threshold significance is at 0.05 level.|ANCOVA|||||||= 0.0015
73882252|NCT03346434|147298506|SUPERIORITY||LS Mean Difference|-2.9|||=|0.0997|TWO_SIDED|95.0|-6.35|0.56||Threshold significance at 0.05 level.|ANCOVA|||||0.56|-6.35|= 0.0997
74061323|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|180.0|||<|0.0001|TWO_SIDED|95.0|164.9|195.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||195.2|164.9|<.0001
74061324|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|181.1|||<|0.0001|TWO_SIDED|95.0|165.9|196.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||196.2|165.9|<.0001
74061325|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|132.3|||<|0.0001|TWO_SIDED|95.0|117.2|147.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||147.5|117.2|<.0001
74102617|NCT02367040|147754978|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in CRR|18.92||||1e-06|TWO_SIDED|95.0|11.11|26.73||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||26.73|11.11|0.000001
74102618|NCT02367040|147754979|SUPERIORITY|DOR was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Kaplan-Meier estimates|0.7||||0.030371|TWO_SIDED|95.0|0.481|1.018||1-sided p-value|Log Rank|||At primary completion date||1.018|0.481|0.030371
74102619|NCT02367040|147754979|SUPERIORITY|DOR was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.761||||0.051976|TWO_SIDED|95.0|0.547|1.059||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.059|0.547|0.051976
74102620|NCT02367040|147754980|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in DCR|4.43||||0.097339|TWO_SIDED|95.0|-2.26|11.12||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||11.12|-2.26|0.097339
74102621|NCT02367040|147754980|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in DCR|4.43||||0.097339|TWO_SIDED|95.0|-2.26|11.12||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||11.12|-2.26|0.097339
74102622|NCT02367040|147754981|SUPERIORITY|TTP was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.476|||<|1e-06|TWO_SIDED|95.0|0.357|0.635||1-sided p-value|Log Rank|||At primary completion date||0.635|0.357|<.000001
74102623|NCT02367040|147754981|SUPERIORITY|TTP was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.505|||<|1e-06|TWO_SIDED|95.0|0.387|0.659||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||0.659|0.387|<.000001
74102624|NCT02367040|147754982|SUPERIORITY|OS was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.972||||0.436458|TWO_SIDED|95.0|0.691|1.368||1-sided p-value|Log Rank|||||1.368|0.691|0.436458
74102625|NCT02367040|147754983|SUPERIORITY|Time to deterioration in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.06||||0.69261|TWO_SIDED|95.0|0.843|1.331||1-sided p-value|Log Rank|||At primary completion date||1.331|0.843|0.692610
74102626|NCT02367040|147754983|SUPERIORITY|Time to deterioration in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.047||||0.661145|TWO_SIDED|95.0|0.841|1.302||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.302|0.841|0.661145
74102627|NCT02367040|147754984|SUPERIORITY|Time to improvement in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.996||||0.510038|TWO_SIDED|95.0|0.732|1.355||1-sided p-value|Log Rank|||At primary completion date||1.355|0.732|0.510038
74102628|NCT02367040|147754984|SUPERIORITY|Time to improvement in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.036||||0.40597|TWO_SIDED|95.0|0.768|1.398||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.398|0.768|0.405970
74102629|NCT03589326|147754999|SUPERIORITY||Risk Difference (RD)|0.18|||=|0.0021|TWO_SIDED|95.0|0.06|0.29||P-value is based on CMH chi-square test, with stratification according to randomization strata (age): 18 through \<45 years, ≥45 through \<60 years, and ≥60 years.|Chi-squared||Risk difference and 95% CI: adjusted percent ponatinib - adjusted percent imatinib and its 95% CI.|||0.29|0.06|=0.0021
74102630|NCT02477618|147755021|SUPERIORITY||Odds Ratio (OR)|1.056||||0.878|TWO_SIDED|95.0|0.527|2.118|||Regression, Logistic|||||2.118|0.527|0.878
74102631|NCT02477618|147755022|SUPERIORITY||Hazard Ratio (HR)|0.747||||0.636|TWO_SIDED|95.0|0.222|2.507|||Regression, Cox|||||2.507|0.222|0.636
73882253|NCT03525444|147298509|SUPERIORITY||Least Squares (LS) Mean Difference|13.8|||<|0.0001|TWO_SIDED|95.0|12.1|15.4|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.||15.4|12.1|<0.0001
74061326|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|137.3|||<|0.0001|TWO_SIDED|95.0|122.1|152.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||152.5|122.1|<.0001
74102632|NCT02477618|147755023|SUPERIORITY||Odds Ratio (OR)|0.623||||0.199|TWO_SIDED|95.0|0.303|1.282|||Regression, Logistic|||||1.282|0.303|0.199
74102633|NCT02477618|147755024|SUPERIORITY||Hazard Ratio (HR)|0.683||||0.328|TWO_SIDED|95.0|0.318|1.466|||Regression, Cox|||||1.466|0.318|0.328
74102634|NCT02477618|147755026|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.339|TWO_SIDED|95.0|0.193|1.763|||Regression, Cox|||||1.763|0.193|0.339
74102635|NCT02477618|147755027|SUPERIORITY||Hazard Ratio (HR)|1.086||||0.817|TWO_SIDED|95.0|0.539|2.189|||Regression, Cox|||||2.189|0.539|0.817
74102636|NCT02477618|147755028|SUPERIORITY||LS Mean Difference|-0.2||||0.567|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.567
74102637|NCT01892722|147755030|SUPERIORITY||||||<|0.001|||||||Negative binomial regression model|||||||<0.001
74102638|NCT01638546|147755069|OTHER||||||||||||||||||The study will be performed as a double-blind, placebo controlled, randomized Phase II in patients with relapsed sensitive or refractory SCLC. Eligible patients will be randomized 1:1 to one of two treatment arms: ABT-888 and temozolomide as the investigational arm, versus placebo and temozolomide as the control arm. The randomization will be stratified by center and by type or relapse (sensitive vs. refractory). The primary objective is to compare the two treatment regimens with respect to efficacy, expressed as Progression Free Survival (PFS) at 4 months post-randomization. PFS will be calculated as proportion of patients alive and without evidence of disease at 4 months after randomization.|||
74102639|NCT00936390|147755105|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.22|TWO_SIDED|95.0|0.65|1.11||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|This study was designed to detect an improvement in the 5-year overall survival rate from 90% (radiation alone arm) to 93.3% (radiation and androgen deprivation arm). Assuming an exponential survival distribution for each arm, this translates to a 34% relative reduction (hazard ratio 0.66) in the yearly death rate. At least 218 deaths provide 85% power with a 1-sided significance level of 0.025 and 85% power.||1.11|0.65|0.22
74102640|NCT00936390|147755106|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.7||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.70|0.39|<0.001
74102641|NCT00936390|147755106|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
73882254|NCT03525444|147298510|SUPERIORITY||LS Mean Difference|14.3|||<|0.0001|TWO_SIDED|95.0|12.7|15.8|||Mixed-effects model for repeated measure|||||15.8|12.7|<0.0001
73882255|NCT03525444|147298511|SUPERIORITY||Rate ratio|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.55|||Negative binomial regression model|||||0.55|0.25|<0.0001
73882256|NCT03525444|147298512|SUPERIORITY||LS Mean Difference|-41.8|||<|0.0001|TWO_SIDED|95.0|-44.4|-39.3|||Mixed-effects model for repeated measure|||||-39.3|-44.4|<0.0001
73882257|NCT03525444|147298513|SUPERIORITY||LS Mean Difference|20.2|||<|0.0001|TWO_SIDED|95.0|17.5|23.0|||Mixed-effects model for repeated measure|||||23.0|17.5|<0.0001
74102642|NCT00936390|147755107|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.02|TWO_SIDED|95.0|0.22|0.9||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.90|0.22|0.020
74102643|NCT00936390|147755107|SUPERIORITY|Cumulative incidence model||||||0.021||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||||||0.021
74102644|NCT00936390|147755109|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.11|0.57||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.57|0.11|<0.001
74102645|NCT00936390|147755109|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
74102646|NCT00936390|147755110|SUPERIORITY||Hazard Ratio (HR)|0.1||||0.0073|TWO_SIDED|95.0|0.01|0.8||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.80|0.01|0.0073
74102647|NCT00936390|147755110|SUPERIORITY|||||||0.007||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.007
74102648|NCT00936390|147755111|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.52|TWO_SIDED|95.0|0.7|1.2||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||1.20|0.70|0.52
74102649|NCT00936390|147755111|SUPERIORITY|||||||0.56||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.56
74102650|NCT00936390|147755112|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.025|TWO_SIDED|95.0|0.41|0.95||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.95|0.41|0.025
74102651|NCT00936390|147755112|SUPERIORITY|||||||0.025||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.025
74102652|NCT00936390|147755114|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74102653|NCT00936390|147755115|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.13|TWO_SIDED|95.0|0.89|1.53||One-sided significance level 0.025 (reported p-value is one-sided)|Gray's test||Reference level = radiation therapy alone arm|||1.53|0.89|0.13
74102654|NCT00936390|147755116|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.7||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.70|0.39|<0.001
74102655|NCT00936390|147755116|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
74102656|NCT00936390|147755117|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||End of RT||||0.38
74102657|NCT00936390|147755117|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||6 months post-RT||||0.032
74102658|NCT00936390|147755117|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||One year post-RT||||0.87
74102659|NCT00936390|147755117|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Five years post-RT||||0.67
74102660|NCT00936390|147755118|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||End of RT||||0.58
74102661|NCT00936390|147755118|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Six months post-RT||||0.31
74102662|NCT00936390|147755118|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||One year post-RT||||0.36
74102663|NCT00936390|147755118|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Five years post-RT||||0.88
74102664|NCT00936390|147755119|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of RT||||<0.001
74102665|NCT00936390|147755119|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Six months post-RT||||<0.001
73882258|NCT03525444|147298514|SUPERIORITY||LS Mean Difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.85|1.23|||Mixed-effects model for repeated measure|||||1.23|0.85|<0.0001
73882259|NCT03525444|147298515|SUPERIORITY||LS Mean Difference|-41.2|||<|0.0001|TWO_SIDED|95.0|-44.0|-38.5|||Mixed-effects model for repeated measure|||||-38.5|-44.0|<0.0001
73882260|NCT03525444|147298516|SUPERIORITY||LS Mean Difference|20.1|||<|0.0001|TWO_SIDED|95.0|16.9|23.2|||Mixed-effects model for repeated measure|||||23.2|16.9|<0.0001
74102666|NCT00936390|147755119|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||One year post-RT||||<0.001
74102667|NCT00936390|147755119|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Five years post-RT||||0.18
74102668|NCT00936390|147755120|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of RT||||<0.001
74102669|NCT00936390|147755120|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Six months post-RT||||<0.001
74102670|NCT00936390|147755120|SUPERIORITY|||||||0.0014|||||||t-test, 2 sided|||One year post-RT||||0.0014
74102671|NCT00936390|147755120|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Five years post-RT||||0.90
74102672|NCT00936390|147755121|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||End of RT||||0.046
74102673|NCT00936390|147755121|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||6 months post-RT||||0.82
74102674|NCT00936390|147755121|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||One year post-RT||||0.82
74102675|NCT00936390|147755121|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Five years post-RT||||0.79
74102676|NCT05905783|147755124|SUPERIORITY||Risk Difference (RD)|13.0|STANDARD_ERROR_OF_MEAN|5.5||0.0183|TWO_SIDED|95.0|2.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|2.2|0.0183
74102677|NCT05905783|147755125|SUPERIORITY||Risk Difference (RD)|15.8|STANDARD_ERROR_OF_MEAN|4.67||0.0007|TWO_SIDED|95.0|6.7|25.0|||Cochran-Mantel-Haenszel|||||25.0|6.7|0.0007
74102678|NCT05905783|147755126|SUPERIORITY||Risk Difference (RD)|14.7|STANDARD_ERROR_OF_MEAN|4.4||0.0008|TWO_SIDED|95.0|6.1|23.4|||Cochran-Mantel-Haenszel|||||23.4|6.1|0.0008
74102679|NCT05905783|147755127|SUPERIORITY||Risk Difference (RD)|12.3|STANDARD_ERROR_OF_MEAN|6.16||0.0462|TWO_SIDED|95.0|0.2|24.3|||Cochran-Mantel-Haenszel|||||24.3|0.2|0.0462
74102680|NCT05905783|147755128|SUPERIORITY||Risk Difference (RD)|-2.8|STANDARD_ERROR_OF_MEAN|5.84||0.6285|TWO_SIDED|95.0|-14.3|8.6|||Cochran-Mantel-Haenszel|||||8.6|-14.3|0.6285
74102681|NCT05905783|147755129|SUPERIORITY||LS Mean Difference|-2.16||||0.0011|TWO_SIDED|95.0|-3.44|-0.88|||Mixed model repeated measures (MMRM)|||||-0.88|-3.44|0.0011
74102682|NCT05905783|147755130|SUPERIORITY||Risk Difference (RD)|24.6|STANDARD_ERROR_OF_MEAN|7.67||0.0013|TWO_SIDED|95.0|9.6|39.7|||Cochran-Mantel-Haenszel|||||39.7|9.6|0.0013
74102683|NCT05905783|147755131|SUPERIORITY||Risk Difference (RD)|16.3|STANDARD_ERROR_OF_MEAN|7.26||0.0245|TWO_SIDED|95.0|2.1|30.6|||Cochran-Mantel-Haenszel|||||30.6|2.1|0.0245
74102684|NCT06988800|147755134|SUPERIORITY||Odds Ratio (OR)|37.1|||<|0.001|TWO_SIDED||||||ANCOVA|||ANCOVAs and post hoc Tukey pairwise tests||||<.001
74102685|NCT06988800|147755135|SUPERIORITY||Odds Ratio (OR)|19.5|||<|0.001|TWO_SIDED||||||ANCOVA|||ANCOVAs and post hoc Tukey pairwise tests.||||<.001
74102686|NCT06988800|147755136|SUPERIORITY||Odds Ratio (OR)|18.7|||<|0.001|TWO_SIDED||||||ANCOVA|||ANCOVAs and post hoc Tukey pairwise tests||||<.001
74102687|NCT07025837|147755142|SUPERIORITY||||||>|0.9999||||||Week 2 compared to the baseline.|ANOVA|||||||>0.9999
74102688|NCT07025837|147755142|SUPERIORITY||||||>|0.9999||||||Week 4 compared to baseline.|ANOVA|||||||>0.9999
74102689|NCT07025837|147755142|SUPERIORITY|||||||0.6342||||||Week 6 compared to baseline.|ANOVA|||||||0.6342
74102690|NCT07025837|147755142|SUPERIORITY|||||||0.0231||||||Week 8 compared to baseline.|ANOVA|||||||0.0231
74102691|NCT07025837|147755142|SUPERIORITY|||||||0.0862||||||Week 10 compared to baseline.|ANOVA|||||||0.0862
74102692|NCT07025837|147755142|SUPERIORITY|||||||0.0033||||||Week 12 compared to baseline.|ANOVA|||||||0.0033
74102693|NCT07025837|147755143|SUPERIORITY|||||||0.1176||||||Week 2 compared to baseline|ANOVA|||||||0.1176
74102694|NCT07025837|147755143|SUPERIORITY|||||||0.003||||||Week 4 compared to baseline.|ANOVA|||||||0.0030
74102695|NCT07025837|147755143|SUPERIORITY|||||||0.0001||||||Week 6 compared to baseline.|ANOVA|||||||0.0001
74102696|NCT07025837|147755143|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
74102697|NCT07025837|147755143|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74102698|NCT07025837|147755144|SUPERIORITY|||||||0.9751||||||Week 2 compared to baseline.|ANOVA|||||||0.9751
74102699|NCT07025837|147755144|SUPERIORITY|||||||0.0078||||||Week 4 compared to baseline.|ANOVA|||||||0.0078
73882261|NCT03525444|147298518|SUPERIORITY||LS Mean Difference|0.3|||||TWO_SIDED|95.0|0.17|0.43||||||||0.43|0.17|
73882262|NCT03525444|147298519|SUPERIORITY||LS Mean Difference|2.9|||||TWO_SIDED|95.0|2.3|3.4||||||||3.4|2.3|
73882263|NCT01183689|147298522|SUPERIORITY||Mean Difference (Net)|0.82|STANDARD_ERROR_OF_MEAN|0.3|<|0.05|TWO_SIDED|95.0|0.23|1.41||No interim analyses were conducted. Pairwise differences among the three arms were assessed with a 2 degree of freedom Wald Test.|Mixed Models Analysis||Above is provided the mean difference between Arms 1 and 2.|Mean changes from random effects model applied to repeated measures to compute the average differences among groups over time.||1.41|0.23|<0.05
74102700|NCT07025837|147755144|SUPERIORITY|||||||0.0003||||||Week 6 compared to baseline.|ANOVA|||||||0.0003
74102701|NCT07025837|147755144|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
74102702|NCT07025837|147755144|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74102703|NCT07025837|147755144|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
74102704|NCT07025837|147755145|SUPERIORITY|||||||0.0544||||||Week 2 compared to baseline.|ANOVA|||||||0.0544
74102705|NCT07025837|147755145|SUPERIORITY|||||||0.0036||||||Week 4 compared to baseline.|ANOVA|||||||0.0036
74102706|NCT07025837|147755145|SUPERIORITY|||||||0.0001||||||Week 6 compared to baseline.|ANOVA|||||||0.0001
74102707|NCT07025837|147755145|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
73882264|NCT01183689|147298522|SUPERIORITY||Mean Difference (Net)|2.64|||<|0.05|TWO_SIDED|95.0|2.05|3.22|||Mixed Models Analysis|This was fitted with Proc Mixed in SAS.|95% confidence interval excludes 0|Mean changes from a random effects model applied to repeated measures to compute the average differences between groups over time. This entry is for the comparison between groups 1 and 3.||3.22|2.05|<0.05
73882265|NCT01183689|147298523|OTHER|Generalized Estimating Equations|Odds Ratio (OR)|1.41|||<|0.05|TWO_SIDED|95.0|1.02|1.9|||Generalized Estimating Equations|||Generalized estimating equations were used to compare the average percent of weight gainers over time among the three groups. The null hypothesis was that there was no difference in these average percentages. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status. The percentages were summarized with odds ratios for weight gain over time.||1.90|1.02|<0.05
73882266|NCT01183689|147298523|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.05|TWO_SIDED|95.0|1.64|3.19|||generalized estimating equations|||This is a parallel analysis, comparing groups 1 and 3, using generalized estimating equations to summarize the odds ratio for weight gain in group 1 versus group 3,||3.19|1.64|<0.05
73882267|NCT01183689|147298524|SUPERIORITY||Mean Difference (Net)|1.31|STANDARD_ERROR_OF_MEAN|0.47|<|0.05|TWO_SIDED|95.0|0.39|2.24|||Mixed Models Analysis|The p-value is based on a 2 degree of freedom Wald test within the mixed effect model to test for pairwise differences among the 3 arms.|Listed above is the mean difference between arms 1 and 2|Mean differences at 2 years are calculated from a linear contrast within a mixed effects model. Note that this comparison is between Groups 1 and 2.||2.24|0.39|<0.05
73882268|NCT01183689|147298524|SUPERIORITY||Median Difference (Net)|2.04|||<|0.05|TWO_SIDED|95.0|1.11|2.98|||Mixed Models Analysis|A linear contrast was used to compare groups 1 and 3 at 24 months.||A linear contrast from a mixed effects model was used to compare mean differences at 24 months between groups 1 and 3.||2.98|1.11|<0.05
74102708|NCT07025837|147755145|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74102709|NCT07025837|147755145|SUPERIORITY||||||<|0.0001||||||Week 12 compared to Baseline|ANOVA|||||||<0.0001
74102710|NCT07025837|147755146|SUPERIORITY|||||||0.0001||||||Week 2 compared to baseline.|ANOVA|||||||0.0001
74102711|NCT07025837|147755146|SUPERIORITY||||||<|0.0001||||||Week 4 compared to baseline.|ANOVA|||||||<0.0001
74102712|NCT07025837|147755146|SUPERIORITY||||||<|0.0001||||||Week 6 compared to baseline.|ANOVA|||||||<0.0001
74102713|NCT07025837|147755146|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
74102714|NCT07025837|147755146|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74102715|NCT07025837|147755146|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
74102716|NCT07025837|147755147|SUPERIORITY|||||||0.1438||||||Week 2 compared to baseline.|ANOVA|||||||0.1438
74102717|NCT07025837|147755147|SUPERIORITY|||||||0.0092||||||Week 4 compared to baseline.|ANOVA|||||||0.0092
74102718|NCT07025837|147755147|SUPERIORITY|||||||0.0003||||||Week 6 compared to baseline.|ANOVA|||||||0.0003
74102719|NCT07025837|147755147|SUPERIORITY|||||||0.0015||||||Week 8 compared to baseline.|ANOVA|||||||0.0015
74102720|NCT07025837|147755147|SUPERIORITY|||||||0.0001||||||Week 10 compared to baseline.|ANOVA|||||||0.0001
74102721|NCT07025837|147755147|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
74102722|NCT07025837|147755148|SUPERIORITY|||||||0.0041||||||Week 2 compared to baseline.|ANOVA|||||||0.0041
74102723|NCT07025837|147755148|SUPERIORITY|||||||0.0001||||||Week 4 compared to baseline.|ANOVA|||||||0.0001
74102724|NCT07025837|147755148|SUPERIORITY||||||<|0.0001||||||Week 6 compared to baseline.|ANOVA|||||||<0.0001
74102725|NCT07025837|147755148|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
74102726|NCT07025837|147755148|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74102727|NCT07025837|147755148|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
74102728|NCT07025837|147755149|SUPERIORITY|||||||0.0249||||||Week 2 compared to baseline.|ANOVA|||||||0.0249
74102729|NCT07025837|147755149|SUPERIORITY||||||<|0.0001||||||Week 4 compared to baseline.|ANOVA|||||||<0.0001
74102730|NCT07025837|147755149|SUPERIORITY||||||<|0.0001||||||Week 6 compared to baseline.|ANOVA|||||||<0.0001
74102731|NCT07025837|147755149|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
74102732|NCT07025837|147755149|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74102733|NCT07025837|147755149|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
74102734|NCT07025837|147755150|SUPERIORITY||||||>|0.9999||||||Week 2 compared to baseline.|ANOVA|||||||>0.9999
74102735|NCT07025837|147755150|SUPERIORITY|||||||0.7453||||||Week 4 compared to baseline|ANOVA|||||||0.7453
74102736|NCT07025837|147755150|SUPERIORITY|||||||0.2118||||||Week 6 compared to baseline.|ANOVA|||||||0.2118
74102737|NCT07025837|147755150|SUPERIORITY|||||||0.0111||||||Week 8 compared to baseline.|ANOVA|||||||0.0111
74061327|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|136.8|||<|0.0001|TWO_SIDED|95.0|122.0|151.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||151.7|122.0|<.0001
74061328|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|150.8|||<|0.0001|TWO_SIDED|95.0|136.0|165.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||165.7|136.0|<.0001
74061329|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|43.2|||<|0.0001|TWO_SIDED|95.0|25.1|61.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||61.4|25.1|<.0001
74061330|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|61.7|||<|0.0001|TWO_SIDED|95.0|43.2|80.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||80.1|43.2|<.0001
74061331|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|36.9|||<|0.0001|TWO_SIDED|95.0|18.6|55.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||55.1|18.6|<.0001
74061332|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|35.5||||0.0002|TWO_SIDED|95.0|16.7|54.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||54.3|16.7|0.0002
74061333|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|38.8|||<|0.0001|TWO_SIDED|95.0|19.9|57.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||57.6|19.9|<.0001
74102738|NCT07025837|147755150|SUPERIORITY|||||||0.015||||||Week 10 compared to baseline.|ANOVA|||||||0.0150
74102739|NCT07025837|147755150|SUPERIORITY|||||||0.0003||||||Week 12 compared to baseline.|ANOVA|||||||0.0003
74102740|NCT07025837|147755151|SUPERIORITY|||||||0.0199||||||Week 2 compared to baseline.|ANOVA|||||||0.0199
74102741|NCT07025837|147755151|SUPERIORITY||||||<|0.0001||||||Week 4 compared to baseline.|ANOVA|||||||<0.0001
74102742|NCT07025837|147755151|SUPERIORITY||||||<|0.0001||||||Week 6 compared to baseline.|ANOVA|||||||<0.0001
74102743|NCT07025837|147755151|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
74102744|NCT07025837|147755151|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline|ANOVA|||||||<0.0001
74102745|NCT07025837|147755151|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
74102746|NCT07025837|147755152|SUPERIORITY|||||||0.4438||||||Week 2 compared to baseline.|ANOVA|||||||0.4438
74102747|NCT07025837|147755152|SUPERIORITY|||||||0.0412||||||Week 4 compared to baseline.|ANOVA|||||||0.0412
74102748|NCT07025837|147755152|SUPERIORITY|||||||0.0943||||||Week 6 compared to baseline|ANOVA|||||||0.0943
74102749|NCT07025837|147755152|SUPERIORITY|||||||0.0017||||||Week 8 compared to baseline.|ANOVA|||||||0.0017
74102750|NCT07025837|147755152|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74102751|NCT07025837|147755152|SUPERIORITY|||||||0.0007||||||Week 12 compared to baseline.|ANOVA|||||||0.0007
74102752|NCT07025837|147755153|SUPERIORITY|||||||0.6148||||||Week 2 compared to baseline.|ANOVA|||||||0.6148
73882269|NCT01183689|147298525|SUPERIORITY||Mean Difference (Net)|1.99||||0.13|TWO_SIDED|95.0|0.06|3.92||The p-value is from a 2 degree of freedom test for pairwise difference among the 3 arms within an analysis of variance.|ANOVA|||Analysis of variance to assess mean differences in changes from baseline in systolic blood pressure. This analysis compares groups 1 and 2.||3.92|0.06|0.13
73882270|NCT01183689|147298525|SUPERIORITY||Mean Difference (Net)|0.93||||0.13|TWO_SIDED|95.0|-0.98|2.84|||ANOVA|||Mean differences in systolic blood pressure between groups 1 and 3 over time.||2.84|-0.98|0.13
73882271|NCT01183689|147298526|SUPERIORITY||Mean Difference (Net)|1.73||||0.06|TWO_SIDED|95.0|0.32|3.14||The p-value is from a 2 degree of freedom F-test from an analysis of variance to compare mean differences among the 3 arms.|ANOVA|||Mean differences from baseline to 2 years were compared among the 3 arms using analysis of variance.||3.14|0.32|0.06
73882272|NCT01183689|147298526|SUPERIORITY||Mean Difference (Net)|0.92||||0.06|TWO_SIDED|95.0|-0.49|2.33||This p-value is from a 2 degree of freedom omnibus test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years in diastolic blood pressure.||2.33|-0.49|0.06
73882273|NCT01183689|147298527|SUPERIORITY||Mean Difference (Net)|-1.3||||0.73|TWO_SIDED|95.0|-6.12|3.52||The p-value results from a 2 degree of freedom F-test.|ANOVA|||Mean changes from baseline to 2 years were compared between Groups 1 and 2.||3.52|-6.12|0.73
73882274|NCT01183689|147298527|SUPERIORITY||Mean Difference (Net)|-1.89||||0.73|TWO_SIDED|95.0|-4.36|0.58||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in total cholesterol changes from baseline among groups.||0.58|-4.36|0.73
73882275|NCT01183689|147298528|SUPERIORITY||Odds Ratio (OR)|2.36|||<|0.001|TWO_SIDED|95.0|1.23|4.52||The p-value is a 2 degree of freedom test from the generalized estimating equations analysis applied to the longitudinal binary data among the 3 study arms.|generalized estimating equations|||The average percentage of participants who were obese across follow-up were compared among the 3 arms using a generalized estimating equations approach for repeated binary measures. Participants were assigned values of 0 or 1 depending on their obesity status at each exam. Differences were summarized with odds ratios.||4.52|1.23|<0.001
73882276|NCT01183689|147298528|SUPERIORITY||Odds Ratio (OR)|2.13||||0.008|TWO_SIDED|95.0|1.12|4.1||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|generalized estimating equations|||Generalized estimating equations were used. Differences were summarized with odds ratios.||4.10|1.12|0.008
74102753|NCT07025837|147755153|SUPERIORITY|||||||0.7953||||||Week 4 compared to baseline.|ANOVA|||||||0.7953
73882277|NCT01183689|147298529|SUPERIORITY||Mean Difference (Net)|-0.08||||0.002|TWO_SIDED|95.0|-0.61|0.45||the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups|ANOVA|the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups||Mean changes from baseline to 2 years among the 3 groups were assessed using a 2 degree of freedom F-test||0.45|-0.61|0.002
73882278|NCT01183689|147298529|SUPERIORITY||Mean Difference (Net)|0.55||||0.002|TWO_SIDED|95.0|0.02|1.08||This p-value is from a 2 degree of freedom test for differences among all 3 groups|ANOVA|||Differences among the 3 groups were based on analyses of variance.||1.08|0.02|0.002
73882279|NCT01183689|147298530|SUPERIORITY|A 2 degree of freedom F-test from ANOVA was used to compare mean differences in changes among the 3 arms of the study.|Mean Difference (Net)|-0.85|||<|0.001|TWO_SIDED|95.0|-1.32|-0.38||The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.|ANOVA|The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.||Changes in units of the scale from baseline to 2 years||-0.38|-1.32|<0.001
73882280|NCT01183689|147298530|SUPERIORITY||Mean Difference (Net)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.57|0.37||This p-value is from a 2 degree of freedom test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.||0.37|-0.57|<0.001
73882281|NCT01183689|147298531|SUPERIORITY|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study|Mean Difference (Net)|0.2|||<|0.001|TWO_SIDED|95.0|-0.31|0.71||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study, not adjusted for multiple comparisons among endpoints|ANOVA|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study||0.71|-0.31|<0.001
73882282|NCT01183689|147298531|SUPERIORITY||Mean Difference (Net)|0.88||||0.002|TWO_SIDED|95.0|0.37|1.39||This p-value is from a 2 degree freedom test of differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to year 2 among the 3 groups.||1.39|0.37|0.002
73882283|NCT01183689|147298532|SUPERIORITY||Mean Difference (Net)|-0.13|||<|0.001|TWO_SIDED|95.0|-0.71|0.45||2 degree of freedom F-test from analysis of variance|ANOVA|2 degree of freedom F-test from analysis of variance to compare mean differences among arms||2 degree F-test from analysis of variance applied to 2 year changes in scores from baseline||0.45|-0.71|<0.001
73882284|NCT01183689|147298532|SUPERIORITY||Median Difference (Net)|1.4|||<|0.001|TWO_SIDED|95.0|0.82|1.98||This p-value is from the omnibus 2 degree of freedom test for mean differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.||1.98|0.82|<0.001
74102754|NCT07025837|147755153|SUPERIORITY|||||||0.0019||||||Week 6 compared to baseline.|ANOVA|||||||0.0019
74102755|NCT07025837|147755153|SUPERIORITY|||||||0.0008||||||Week 8 compared to baseline.|ANOVA|||||||0.0008
74102756|NCT07025837|147755153|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74102757|NCT07025837|147755153|SUPERIORITY|||||||0.0002||||||Week 12 compared to baseline.|ANOVA|||||||0.0002
74102758|NCT07025837|147755154|SUPERIORITY|||||||0.0067||||||Week 2 compared to baseline.|ANOVA|||||||0.0067
74102759|NCT07025837|147755154|SUPERIORITY|||||||0.0055||||||Week 4 compared to baseline.|ANOVA|||||||0.0055
74102760|NCT07025837|147755154|SUPERIORITY||||||<|0.0001||||||Week 6 compared to baseline.|ANOVA|||||||<0.0001
74102761|NCT07025837|147755154|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
74102762|NCT07025837|147755154|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74102763|NCT07025837|147755154|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
74061334|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|44.9|||<|0.0001|TWO_SIDED|95.0|26.0|63.8|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||63.8|26.0|<.0001
74061335|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-47.7||||0.0002|TWO_SIDED|95.0|-78.0|-17.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-17.4|-78.0|0.0002
74061336|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-43.8||||0.0009|TWO_SIDED|95.0|-74.1|-13.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-13.4|-74.1|0.0009
74061337|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-43.2||||0.0009|TWO_SIDED|95.0|-73.2|-13.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-13.3|-73.2|0.0009
74061338|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-30.2||||0.0466|TWO_SIDED|95.0|-60.2|-0.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.3|-60.2|0.0466
74061339|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-136.8|||<|0.0001|TWO_SIDED|95.0|-170.4|-103.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-103.3|-170.4|<.0001
74061340|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-119.4|||<|0.0001|TWO_SIDED|95.0|-153.3|-85.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-85.5|-153.3|<.0001
74102764|NCT07025837|147755155|SUPERIORITY|||||||0.1476||||||Week 2 compared to baseline.|ANOVA|||||||0.1476
74102765|NCT07025837|147755155|SUPERIORITY|||||||0.0106||||||Week 4 compared to baseline.|ANOVA|||||||0.0106
74102766|NCT07025837|147755155|SUPERIORITY|||||||0.0002||||||Week 6 compared to baseline.|ANOVA|||||||0.0002
74102767|NCT07025837|147755155|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline|ANOVA|||||||<0.0001
74102768|NCT07025837|147755155|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74102769|NCT07025837|147755155|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
74102770|NCT07025837|147755156|SUPERIORITY|||||||0.3224||||||Week 2 compared to baseline.|ANOVA|||||||0.3224
74102771|NCT07025837|147755156|SUPERIORITY|||||||0.0426||||||Week 4 compared to baseline.|ANOVA|||||||0.0426
74102772|NCT07025837|147755156|SUPERIORITY|||||||0.0039||||||Week 6 compared to baseline.|ANOVA|||||||0.0039
74102773|NCT07025837|147755156|SUPERIORITY|||||||0.004||||||Week 8 compared to baseline.|ANOVA|||||||0.0040
74102774|NCT07025837|147755156|SUPERIORITY|||||||0.0013||||||Week 10 compared to baseline.|ANOVA|||||||0.0013
73888237|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.88|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.88|-1.21|<0.0001
74102775|NCT07025837|147755156|SUPERIORITY|||||||0.0005||||||Week 12 compared to baseline.|ANOVA|||||||0.0005
74061341|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-143.2|||<|0.0001|TWO_SIDED|95.0|-176.6|-109.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-109.7|-176.6|<.0001
74061342|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-145.6|||<|0.0001|TWO_SIDED|95.0|-179.7|-111.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-111.4|-179.7|<.0001
74061343|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|93.6|||<|0.0001|TWO_SIDED|95.0|60.0|127.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||127.2|60.0|<.0001
74061344|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|92.4|||<|0.0001|TWO_SIDED|95.0|58.8|126.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||126.1|58.8|<.0001
74061345|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|98.1|||<|0.0001|TWO_SIDED|95.0|64.6|131.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||131.5|64.6|<.0001
74061346|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|106.0|||<|0.0001|TWO_SIDED|95.0|72.5|139.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||139.4|72.5|<.0001
74061347|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|4.5||||1|TWO_SIDED|95.0|-32.0|40.9|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||40.9|-32.0|1.0000
74061348|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|16.8||||0.7714|TWO_SIDED|95.0|-20.0|53.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||53.5|-20.0|0.7714
74061349|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-1.9||||1|TWO_SIDED|95.0|-38.3|34.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||34.5|-38.3|1.0000
74102776|NCT07025837|147755157|SUPERIORITY|||||||0.3032||||||Week 2 compared to baseline.|ANOVA|||||||0.3032
74061350|NCT03692078|147674437|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-9.4||||0.9926|TWO_SIDED|95.0|-46.4|27.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||27.6|-46.4|0.9926
74061351|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.872|||<|0.0001|TWO_SIDED|95.0|1.81|1.935|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.935|1.810|<.0001
74061352|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.913|||<|0.0001|TWO_SIDED|95.0|1.851|1.976|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.976|1.851|<.0001
74061353|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.467|||<|0.0001|TWO_SIDED|95.0|1.408|1.525|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.525|1.408|<.0001
74061354|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.493|||<|0.0001|TWO_SIDED|95.0|1.434|1.551|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.551|1.434|<.0001
74061355|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.55|||<|0.0001|TWO_SIDED|95.0|1.49|1.609|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.609|1.490|<.0001
74061356|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.594|||<|0.0001|TWO_SIDED|95.0|1.533|1.654|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.654|1.533|<.0001
74061357|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.557|||<|0.0001|TWO_SIDED|95.0|0.482|0.631|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||0.631|0.482|<.0001
74102777|NCT07025837|147755157|SUPERIORITY|||||||0.0237||||||Week 4 compared to baseline.|ANOVA|||||||0.0237
74102778|NCT07025837|147755157|SUPERIORITY|||||||0.001||||||Week 6 compared to baseline.|ANOVA|||||||0.0010
74102779|NCT07025837|147755157|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
74102780|NCT07025837|147755157|SUPERIORITY|||||||0.0002||||||Week 10 compared to baseline.|ANOVA|||||||0.0002
74102781|NCT07025837|147755157|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
74102782|NCT07025837|147755158|SUPERIORITY||||||>|0.9999||||||Week 2 compared to baseline.|ANOVA|||||||>0.9999
74102783|NCT07025837|147755158|SUPERIORITY|||||||0.1147||||||Week 4 compared to baseline|ANOVA|||||||0.1147
74102784|NCT07025837|147755158|SUPERIORITY|||||||0.0016||||||Week 6 compared to baseline.|ANOVA|||||||0.0016
74102785|NCT07025837|147755158|SUPERIORITY|||||||0.0048||||||Week 8 compared to baseline.|ANOVA|||||||0.0048
74102786|NCT07025837|147755158|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74061358|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.589|||<|0.0001|TWO_SIDED|95.0|0.514|0.665|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.665|0.514|<.0001
74061359|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.533|||<|0.0001|TWO_SIDED|95.0|0.461|0.605|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.605|0.461|<.0001
74061360|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.588|||<|0.0001|TWO_SIDED|95.0|0.514|0.662|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.662|0.514|<.0001
74061361|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.58|||<|0.0001|TWO_SIDED|95.0|0.508|0.652|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.652|0.508|<.0001
74061362|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.58|||<|0.0001|TWO_SIDED|95.0|0.507|0.653|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||0.653|0.507|<.0001
74061363|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.406|||<|0.0001|TWO_SIDED|95.0|-0.526|-0.285|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.285|-0.526|<.0001
74061364|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.421|||<|0.0001|TWO_SIDED|95.0|-0.541|-0.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.300|-0.541|<.0001
74102787|NCT07025837|147755158|SUPERIORITY|||||||0.0005||||||Week 12 compared to baseline.|ANOVA|||||||0.0005
73882285|NCT01183689|147298533|SUPERIORITY||Mean Difference (Net)|-0.08||||0.24|TWO_SIDED|95.0|-0.24|0.09||This p-value is from a 2 degree of freedom test for differences among the 3 arms.|ANOVA|2 degree of freedom test from analysis of variance to assess mean differences among the 3 arms||2 degree of freedom F-test from analysis of variance to compare 2 year differences in general health index values among the 3 arms||0.09|-0.24|0.24
74061365|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.323|||<|0.0001|TWO_SIDED|95.0|-0.444|-0.201|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.201|-0.444|<.0001
74102788|NCT07025837|147755159|SUPERIORITY|||||||0.0461||||||Week 2 compared to baseline.|ANOVA|||||||0.0461
74102789|NCT07025837|147755159|SUPERIORITY|||||||0.002||||||Week 4 compared to baseline.|ANOVA|||||||0.002
74102790|NCT07025837|147755159|SUPERIORITY|||||||0.0002||||||Week 6 compared to baseline.|ANOVA|||||||0.0002
74102791|NCT07025837|147755159|SUPERIORITY||||||<|0.0001||||||Week 8 compared to baseline.|ANOVA|||||||<0.0001
74102792|NCT07025837|147755159|SUPERIORITY||||||<|0.0001||||||Week 10 compared to baseline.|ANOVA|||||||<0.0001
74102793|NCT07025837|147755159|SUPERIORITY||||||<|0.0001||||||Week 12 compared to baseline.|ANOVA|||||||<0.0001
74061366|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.442|-0.198|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.198|-0.442|<.0001
74061367|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.315|||<|0.0001|TWO_SIDED|95.0|-1.453|-1.178|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.178|-1.453|<.0001
74061368|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.324|||<|0.0001|TWO_SIDED|95.0|-1.463|-1.186|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.186|-1.463|<.0001
74061369|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.339|||<|0.0001|TWO_SIDED|95.0|-1.473|-1.205|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.205|-1.473|<.0001
74061370|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.325|||<|0.0001|TWO_SIDED|95.0|-1.461|-1.19|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.190|-1.461|<.0001
74061371|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.887|||<|0.0001|TWO_SIDED|95.0|0.757|1.016|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.016|0.757|<.0001
74061372|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.912|||<|0.0001|TWO_SIDED|95.0|0.782|1.043|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.043|0.782|<.0001
74102794|NCT03907488|147755160|SUPERIORITY||||||<|0.005||||||One sided P-value|Log Rank|||The primary analysis of PFS used a stratified log rank test statistic and is reported as two-sided test. Stratified Cox regression was used to estimate treatment hazard ratios for treatment effect. 95% two-sided intervals are reported. The Kaplan-Meier method was used to estimate PFS curves.||||<0.005
74102795|NCT03896750|147755165|EQUIVALENCE|Equivalence analysis by 90% confidence interval. If the interval encompasses 1 there is no clinically meaningful difference in pretomanid AUC(0-last). Assuming a 20% coefficient of variation for the AUC(0-last) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%|Mean Ratio|0.83|||||TWO_SIDED|90.0|0.54|1.26|||Regression, Linear|Adjusted for site||No formal hypothesis testing was conducted. Assuming a 20% coefficient of variation for the AUC(0-last) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%.||1.26|0.54|
73882286|NCT01183689|147298533|SUPERIORITY||Mean Difference (Net)|-0.15||||0.24|TWO_SIDED|95.0|-0.32|0.02||This p-value is from the 2 degree of freedom test of differences among the 3 arms.|ANOVA|||Analysis of variance was used to compare differences in changes from baseline to 2 years among the three arms.||0.02|-0.32|0.24
74061373|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.97|||<|0.0001|TWO_SIDED|95.0|0.839|1.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.100|0.839|<.0001
74102796|NCT03896750|147755165|EQUIVALENCE|Equivalence analysis by 90% confidence interval. If the interval encompasses 1 there is no clinically meaningful difference in pretomanid AUC(0-last). Assuming a 20% coefficient of variation for the AUC(0-last) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%|Mean Ratio|0.87|||||TWO_SIDED|90.0|0.67|1.14|||Regression, Linear|Adjusted for site||No formal hypothesis testing was conducted. Assuming a 20% coefficient of variation for the AUC(0-last) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%||1.14|0.67|
74102797|NCT03896750|147755166|EQUIVALENCE|Equivalence analysis by 90% confidence interval. If the interval encompasses 1 there is no clinically meaningful difference in pretomanid AUC(0-infinity). Assuming a 20% coefficient of variation for the AUC(0-infinity) of both groups, the probability of observing at least 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%|Mean Ratio|0.87|||||TWO_SIDED|90.0|0.54|1.39|||Regression, Linear|Adjusted for site||No formal hypothesis testing was conducted. Assuming a 20% coefficient of variation for the AUC(0-infinity) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%||1.39|0.54|
74102798|NCT03896750|147755166|EQUIVALENCE|Equivalence analysis by 90% confidence interval. If the interval encompasses 1 there is no clinically meaningful difference in pretomanid AUC(0-infinity). Assuming a 20% coefficient of variation for the AUC(0-infinity) of both groups, the probability of observing at least 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%|Mean Ratio|0.95|||||TWO_SIDED|90.0|0.71|1.28|||Regression, Linear|Adjusted for site||No formal hypothesis testing was conducted. Assuming a 20% coefficient of variation for the AUC(0-infinity) of both groups, the probability of observing at least a 50% increase in the geometric mean ratio of AUCs given a true 100% increase is \>99%. The probability of the lower bound of the 90% CI for the geometric mean ratio of AUCs being at least 1.5 in this scenario is approximately 70%||1.28|0.71|
74102799|NCT03524092|147755191|SUPERIORITY||Risk Difference (RD)|23.2|||<|0.001|TWO_SIDED|95.0|15.2|31.2|||Cochran-Mantel-Haenszel|||||31.2|15.2|<0.001
74102800|NCT03524092|147755192|SUPERIORITY||Risk Difference (RD)|28.5|||<|0.001|TWO_SIDED|95.0|20.2|36.8|||Cochran-Mantel-Haenszel|||||36.8|20.2|<0.001
74102801|NCT03524092|147755193|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|14.5|30.5|||Cochran-Mantel-Haenszel|||||30.5|14.5|<0.001
74102802|NCT03524092|147755194|SUPERIORITY||Risk Difference (RD)|30.2|||<|0.001|TWO_SIDED|95.0|21.9|38.6|||Cochran-Mantel-Haenszel|||||38.6|21.9|<0.001
74102803|NCT03524092|147755195|SUPERIORITY||Risk Difference (RD)|31.0|||<|0.001|TWO_SIDED|95.0|22.4|39.6|||Cochran-Mantel-Haenszel|||||39.6|22.4|<0.001
74102804|NCT03524092|147755196|SUPERIORITY||Risk Difference (RD)|30.6|||<|0.001|TWO_SIDED|95.0|22.3|38.9|||Cochran-Mantel-Haenszel|||||38.9|22.3|<0.001
74102805|NCT03524092|147755197|SUPERIORITY||LS Mean difference (Final Values)|25.24|STANDARD_ERROR_OF_MEAN|3.094|<|0.001|TWO_SIDED|95.0|19.16|31.32|||ANCOVA|ANCOVA with modified baseline observation carried forward (mBOCF).||||31.32|19.16|<0.001
74102806|NCT03524092|147755198|SUPERIORITY||LS Mean difference (Final Values)|-839.64|STANDARD_ERROR_OF_MEAN|245.99|<|0.001|TWO_SIDED|95.0|-1323.08|-356.21|||ANCOVA|ANCOVA with modified baseline observation carried forward (mBOCF).||||-356.21|-1323.08|<0.001
74102807|NCT03524092|147755199|SUPERIORITY||LS Mean difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.228|<|0.001|TWO_SIDED|95.0|-1.51|-0.61|||Mixed Models Analysis|||||-0.61|-1.51|<0.001
74102808|NCT04303780|147755202|EQUIVALENCE|A hazard ratio \<1.0 indicates a lower average event rate and a longer PFS for AMG 510 relative to docetaxel. P-value was calculated using a stratified log-rank test.|Hazard Ratio (HR)|0.663||||0.002|TWO_SIDED|95.0|0.509|0.864|||Log Rank|||||0.864|0.509|0.002
74102809|NCT03968224|147755213|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74102810|NCT03968224|147755214|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74061374|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.013|||<|0.0001|TWO_SIDED|95.0|0.882|1.145|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.145|0.882|<.0001
74061375|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.023||||0.9999|TWO_SIDED|95.0|-0.168|0.122|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.122|-0.168|0.9999
74061376|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.009||||1|TWO_SIDED|95.0|-0.138|0.155|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.155|-0.138|1.0000
74061377|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.047||||0.9577|TWO_SIDED|95.0|-0.189|0.095|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.095|-0.189|0.9577
74061378|NCT03692078|147674439|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.008||||1|TWO_SIDED|95.0|-0.136|0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.152|-0.136|1.0000
74061379|NCT01563029|147674447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|9.6|22.4|||ANCOVA|Gate-keeper analysis||||22.4|9.6|<0.001
74061380|NCT01563029|147674447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|||<|0.001|TWO_SIDED|95.0|5.1|19.8|||ANCOVA||Inference for FF 100 μg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparison.|||19.8|5.1|<0.001
74102811|NCT03968224|147755215|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74102812|NCT03968224|147755216|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
74061381|NCT01563029|147674447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.5|||<|0.001|TWO_SIDED|95.0|12.1|26.9|||ANCOVA||Inference for FF 100 µg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparsion.|||26.9|12.1|<0.001
74061382|NCT01563029|147674447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|||<|0.001|TWO_SIDED|95.0|11.3|26.0|||ANCOVA||Inference for FF 25 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for both the FF 100 ug versus placebo comparison and the FF 50 ug versus placebocomparison.|||26.0|11.3|<0.001
74061383|NCT01563029|147674447|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|14.0|||<|0.001|TWO_SIDED|95.0|6.7|21.4|||ANCOVA|||||21.4|6.7|<0.001
74061384|NCT01563029|147674448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|||<|0.001|TWO_SIDED|95.0|0.051|0.201|||ANCOVA|||||0.201|0.051|<0.001
74061385|NCT01563029|147674448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022||||0.551|TWO_SIDED|95.0|-0.05|0.094|||ANCOVA|||||0.094|-0.050|0.551
74061386|NCT01563029|147674448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.379|TWO_SIDED|95.0|-0.041|0.108|||ANCOVA|||||0.108|-0.041|0.379
74061387|NCT01563029|147674448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.089|TWO_SIDED|95.0|-0.01|0.137|||ANCOVA|||||0.137|-0.010|0.089
74061388|NCT01563029|147674449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4||||0.05|TWO_SIDED|95.0|0.0|16.9|||ANCOVA|||||16.9|0.0|0.050
74061389|NCT01563029|147674449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8||||0.023|TWO_SIDED|95.0|1.3|18.2|||ANCOVA|||||18.2|1.3|0.023
74102813|NCT04533646|147755220|OTHER||Mean Difference (Net)|1.1|||<|0.01|TWO_SIDED||||||Means testing||||comparison of means test was performed|||<0.01
74102814|NCT00336024|147755222|SUPERIORITY|||||||0.35|||||||Chi-squared|||The CR rates between these two groups will be compared at a significance level of 0.1 using one-sided Chi-square test.||||0.35
74102815|NCT00336024|147755224|SUPERIORITY|||||||0.2|||||||Log Rank|||The difference in incidence for the two treatment regimens will be compared using a one-sided log-rank test with a significance level 0.1.||||0.2
74102816|NCT00336024|147755225|SUPERIORITY|||||||1|||||||Fisher Exact|||The two groups will be compared for patterns of failure to detect a statistically significant difference using Fisher exact test.||||1.00
74061390|NCT01563029|147674449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.2||||0.004|TWO_SIDED|95.0|3.8|20.5|||ANCOVA|||||20.5|3.8|0.004
74061391|NCT01563029|147674449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.143|TWO_SIDED|95.0|-2.1|14.6|||ANCOVA|||||14.6|-2.1|0.143
74061392|NCT01563029|147674450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.005|TWO_SIDED|95.0|3.4|19.0|||ANCOVA|||||19.0|3.4|0.005
74061393|NCT01563029|147674450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4|||<|0.001|TWO_SIDED|95.0|5.7|21.1|||ANCOVA|||||21.1|5.7|<0.001
74061394|NCT01563029|147674450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|||<|0.033|TWO_SIDED|95.0|0.7|16.1|||ANCOVA|||||16.1|0.7|<0.033
74061395|NCT01563029|147674450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0||||0.042|TWO_SIDED|95.0|0.3|15.7|||ANCOVA|||||15.7|0.3|0.042
74102817|NCT00336024|147755226|SUPERIORITY|||||||0.74|||||||Log Rank|||Difference in incidence for the two treatment regimens will be compared using log-rank test.||||0.74
74102818|NCT00336024|147755227|SUPERIORITY|||||||1|||||||Fisher Exact|||The rate of acute hearing loss between two treatment regimens will be be compared using Fisher exact test.||||1.00
74102819|NCT00336024|147755233|SUPERIORITY|||||||0.8|||||||Fisher Exact|||The rate of chronic hearing loss between two treatment regimens will be be compared using Fisher exact test.||||0.8
73882287|NCT01183689|147298534|SUPERIORITY||Mean Difference (Net)|1.52||||0.16|TWO_SIDED|95.0|-0.77|3.81||This p-value is from a 2 degree of freedom F-test to compare the 3 arms using analysis of variance.|ANOVA|||Mean differences between baseline and year 2 were compared among the 3 arms using analysis of variance.||3.81|-0.77|0.16
73882288|NCT01183689|147298534|SUPERIORITY||Mean Difference (Net)|2.21||||0.16|TWO_SIDED|95.0|-0.09|4.51||This p-value is from a 2 degree of freedom F test.|ANOVA|||Analysis of variance was used to compared mean differences among the 3 groups.||4.51|-0.09|0.16
74061396|NCT01563029|147674451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.037|TWO_SIDED|95.0|0.7|21.7|||ANCOVA|||||21.7|0.7|0.037
74061397|NCT01563029|147674451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.1||||0.014|TWO_SIDED|95.0|2.6|23.6|||ANCOVA|||||23.6|2.6|0.014
74061398|NCT01563029|147674451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.266|TWO_SIDED|95.0|-4.5|16.3|||ANCOVA|||||16.3|-4.5|0.266
74061399|NCT01563029|147674451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.242|TWO_SIDED|95.0|-4.2|16.6|||ANCOVA|||||16.6|-4.2|0.242
74061400|NCT01563029|147674452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|||<|0.001|TWO_SIDED|95.0|10.0|31.3|||ANCOVA|||||31.3|10.0|<0.001
74061401|NCT01563029|147674452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.9||||0.001|TWO_SIDED|95.0|7.2|28.6|||ANCOVA|||||28.6|7.2|0.001
74061402|NCT01563029|147674452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.5||||0.033|TWO_SIDED|95.0|0.9|22.1|||ANCOVA|||||22.1|0.9|0.033
74061403|NCT01563029|147674452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.002|TWO_SIDED|95.0|6.0|27.3|||ANCOVA|||||27.3|6.0|0.002
74061404|NCT01563029|147674453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.619|TWO_SIDED|95.0|-6.1|10.2|||ANCOVA|||||10.2|-6.1|0.619
74061405|NCT01563029|147674453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8||||0.161||95.0|-2.3|13.9|||ANCOVA|||||13.9|-2.3|0.161
74061406|NCT01563029|147674453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.34|TWO_SIDED|95.0|-4.1|12.0|||ANCOVA|||||12.0|-4.1|0.340
74061407|NCT01563029|147674453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.459|TWO_SIDED|95.0|-5.0|11.1|||ANCOVA|||||11.1|-5.0|0.459
74061408|NCT01563029|147674454|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
74061409|NCT01563029|147674454|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Fisher Exact|||||||0.006
74061410|NCT01563029|147674454|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
74061411|NCT01563029|147674454|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
74061412|NCT02861534|147674468|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.269|TWO_SIDED|95.0|0.81|1.06|||Cox proportional hazard model|||||1.06|0.81|0.269
74061413|NCT02861534|147674469|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.048|TWO_SIDED|95.0|0.81|1.0|||Cox proportional hazard model|||||1.00|0.81|0.048
74061414|NCT02861534|147674470|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.019|TWO_SIDED|95.0|0.82|0.98|||Cox proportional hazard model|||||0.98|0.82|0.019
74061415|NCT02861534|147674471|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.023|TWO_SIDED|95.0|0.84|0.99|||Andersen-Gill model|||||0.99|0.84|0.023
74061416|NCT02861534|147674472|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.021|TWO_SIDED|95.0|0.83|0.98|||Cox proportional hazard model|||||0.98|0.83|0.021
74061417|NCT02861534|147674473|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.377|TWO_SIDED|95.0|0.84|1.07|||Cox proportional hazard model|||||1.07|0.84|0.377
74061418|NCT02861534|147674476|OTHER||Difference in Percentage|1.2||||0.121|TWO_SIDED|95.0|-0.3|2.8|||Miettinen & Nurminen method|||||2.8|-0.3|0.121
74061419|NCT02861534|147674477|OTHER||Difference in Percentage|0.6||||0.303|TWO_SIDED|95.0|-0.5|1.6|||Miettinen & Nurminen method|||||1.6|-0.5|0.303
74061420|NCT01294709|147674498|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-6.9|||||TWO_SIDED|90.0|-17.66|3.86|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||3.86|-17.66|
74061421|NCT01294709|147674499|SUPERIORITY_OR_OTHER||Difference in Least squares meand|-0.056|||||TWO_SIDED|90.0|-0.19|0.076|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||0.076|-0.19|
74102820|NCT00336024|147755234|SUPERIORITY|||||||0.27|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase I. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.27
74102821|NCT00336024|147755234|SUPERIORITY|||||||0.07|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase II. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.07
74102822|NCT00336024|147755234|SUPERIORITY|||||||0.2|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.2
73882289|NCT01183689|147298535|SUPERIORITY||Mean Difference (Net)|0.17||||0.75|TWO_SIDED|95.0|-3.89|4.23||This p-value is from a 2 degree of freedom F-test from analysis of variance.|ANOVA|||Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.||4.23|-3.89|0.75
74061422|NCT01294709|147674500|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.14|||||TWO_SIDED|90.0|-22.03|7.74|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||7.74|-22.03|
73882290|NCT01183689|147298535|SUPERIORITY||Mean Difference (Net)|1.44||||0.75|TWO_SIDED|95.0|-2.61|5.49||This p-value is from a 2 degree of freedom test.|ANOVA||No significant differences between groups 1 and 3.|Analysis of variance was used to compare mean changes among the 3 groups.||5.49|-2.61|0.75
74061423|NCT04854707|147674501|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74061424|NCT04854707|147674501|OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
74061425|NCT04854707|147674502|OTHER||Mean Difference (Final Values)|0.017||||0.314|TWO_SIDED|95.0|-0.0161|0.0501|||Chi-squared|z-value = 1||95% Confidence intervals (CIs) of point estimates were calculated using the exact binominal distribution (Clopper-Pearson method) for proportions||0.0501|-0.0161|0.314
74061426|NCT04854707|147674502|OTHER||Mean Difference (Final Values)|0.0207||||0.482|TWO_SIDED|95.0|-0.0369|0.0782|||Chi-squared|||95% Confidence intervals (CIs) of point estimates were calculated using the exact binominal distribution (Clopper-Pearson method) for proportions||0.0782|-0.0369|0.482
74061427|NCT04854707|147674503|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74061428|NCT04854707|147674503|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73882291|NCT01183689|147298536|SUPERIORITY||Mean Difference (Net)|-1.08||||0.05|TWO_SIDED|95.0|-2.44|0.28||This p-value is from a 2 degree of freedom F-test to compare the 3 arms within an analysis of variance.|ANOVA||No significant difference between groups 1 and 2.|Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.||0.28|-2.44|0.05
73882292|NCT01183689|147298536|SUPERIORITY||Mean Difference (Net)|-1.66||||0.05|TWO_SIDED|95.0|-3.0|-0.32||This p-value is from an F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.||-0.32|-3.00|0.05
74061429|NCT04854707|147674504|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74102823|NCT00336024|147755234|SUPERIORITY|||||||0.4|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 1. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.4
74102824|NCT00336024|147755234|SUPERIORITY|||||||0.38|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 2. The difference in the number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.38
74061430|NCT04854707|147674505|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74061431|NCT04854707|147674505|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74061432|NCT01612780|147674509|SUPERIORITY||||||<|0.0001||||||Values of p \<0.05 were deemed statistically significant.|t-test, 2 sided|||Study sample size was established to test the hypothesis that the mean SNOT-20 score is reduced by at least 0.8 points from baseline to 1 year post procedure. Using this delta, a 1-sided alpha of 0.25, and 90% power, a sample size of 19 participants was adequate to test the hypothesis.||||<0.0001
74061433|NCT03466060|147674512|SUPERIORITY||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.23|||TWO_SIDED|95.0|-6.4|2.3||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|bayesian multivariate hierarachical||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis||2.3|-6.4|
74061434|NCT03466060|147674512|SUPERIORITY||Posertior Mean Difference|-2.5|STANDARD_DEVIATION|2.16|||TWO_SIDED|95.0|-6.8|1.7||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian Multivariate Hierarchical Model||Posterior mean difference was calculated as Test-Control.|5-minute Follow-up Analysis||1.7|-6.8|
74061435|NCT03466060|147674512|SUPERIORITY||Posterior Mean Difference|-2.7|STANDARD_DEVIATION|2.1|||TWO_SIDED|95.0|-6.9|1.5||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian multivariate hierarchical model||Posterior mean difference was calculated as Test-Control.|45-Minute Follolw-up Analysis||1.5|-6.9|
74061436|NCT03466060|147674512|SUPERIORITY||Posterior Mean Difference|-2.5|STANDARD_DEVIATION|2.01|||TWO_SIDED|95.0|-6.5|1.4|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis||1.4|-6.5|
74061437|NCT03466060|147674512|SUPERIORITY||Posterior Mean Difference|-1.1|STANDARD_DEVIATION|2.28|||TWO_SIDED|95.0|-5.8|3.1|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis||3.1|-5.8|
74061438|NCT03466060|147674512|SUPERIORITY|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-0.7|STANDARD_DEVIATION|2.2|||TWO_SIDED|95.0|-5.0|3.6|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|5-Minute Follow-up Analysis||3.6|-5.0|
74061439|NCT03466060|147674512|NON_INFERIORITY|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-2.0|STANDARD_DEVIATION|2.16|||TWO_SIDED|95.0|-6.4|2.3|||Bayesian Multivariate Hierarchical Model||Posterior mean difference was calculated as Test-Control.|45-Minute Follow-up Analysis||2.3|-6.4|
74061440|NCT03466060|147674512|SUPERIORITY||Posterior Mean Difference|-1.5|STANDARD_DEVIATION|2.1|||TWO_SIDED|95.0|-5.8|2.5||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian Mutlivariate Hiearachical Model||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis||2.5|-5.8|
74102825|NCT00336024|147755234|SUPERIORITY|||||||0.7|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.7
74102826|NCT00336024|147755235|SUPERIORITY|||||||0.08|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.08
73882293|NCT01183689|147298537|SUPERIORITY||Mean Difference (Net)|-0.46||||0.03|TWO_SIDED|95.0|-1.37|0.45||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess differences among the 3 arms.|ANOVA|||Mean changes between baseline and year 2 were compared among the 3 arms using analysis of variance.||0.45|-1.37|0.03
73882294|NCT01183689|147298537|SUPERIORITY||Mean Difference (Net)|-1.21||||0.03|TWO_SIDED|95.0|-2.11|-0.3||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences from baseline to 2 years among the 3 groups.||-0.30|-2.11|0.03
73882295|NCT01183689|147298538|SUPERIORITY||Mean Difference (Net)|1.08||||0.2|TWO_SIDED|95.0|-0.84|3.0||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess mean differences among the 3 arms.|ANOVA||The 95% confidence interval for differences between groups 1 and 2 includes 0.|Mean differences from baseline to year 2 among the 3 arms were assessed using analysis of variance.||3.00|-0.84|0.20
73882296|NCT01183689|147298538|SUPERIORITY||Mean Difference (Net)|-0.05||||0.2|TWO_SIDED|95.0|-1.45|1.35||This p-value is from an analysis of variance comparing all 3 groups.|ANOVA||The 95% confidence interval for differences between groups 1 and 3 includes 0.|Analysis of variance was used to compare differences among the 3 groups.||1.35|-1.45|0.20
74061441|NCT04007406|147674513|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold value for statistical significance was p\<0.05|Mixed Models Analysis|||||||<0.0001
74061442|NCT04007406|147674514|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
74061443|NCT04007406|147674515|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
74061444|NCT04007406|147674516|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
74102827|NCT00336024|147755235|SUPERIORITY|||||||0.9|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.9
73882297|NCT01183689|147298539|SUPERIORITY||Mean Difference (Net)|-0.12||||0.02|TWO_SIDED|95.0|-0.34|0.1||2 degree of freedom F-test from analysis of variance, with no adjustment for multiple outcomes|ANOVA|||2 degree of freedom F-test to compare mean 2 year differences among 3 arms||0.10|-0.34|0.02
74061445|NCT04007406|147674517|SUPERIORITY||||||<|0.0001||||||The statistical threshold was p\<0.05|Mixed Models Analysis|||||||<0.0001
73882298|NCT01183689|147298539|SUPERIORITY||Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|95.0|-0.52|-0.08||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.||-0.08|-0.52|0.02
73882299|NCT01183689|147298540|SUPERIORITY||Mean Difference (Net)|-52.0||||0.58|TWO_SIDED|95.0|-164.0|60.0||2 degree of freedom F-test to compare 3 arms with respect to 2-year changes in kilocalories|ANOVA|||2 degree of freedom F-test to compare mean differences among 3 arms in changes in kilocalories from baseline to year 2||60|-164|0.58
73882300|NCT01183689|147298540|SUPERIORITY||Mean Difference (Net)|-50.0||||0.58|TWO_SIDED|95.0|-162.0|61.0||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups|ANOVA|||Analysis of variance was used to assess mean differences in 2 year changes in kilocalories intake among the 3 groups.||61|-162|0.58
73882301|NCT01183689|147298541|SUPERIORITY||Mean Difference (Net)|-1.27||||0.001|TWO_SIDED|95.0|-2.55|0.02||2 degree of freedom F-test from analysis of variance to compare changes in waist circumference from baseline among the three arms|ANOVA|No adjustment to degrees of freedom|Difference between groups 1 and 2: 95% confidence interval includes 0|2 degree of freedom F-test from ANOVA to compare differences among 3 arms||0.02|-2.55|0.001
74061446|NCT02072174|147674526|SUPERIORITY|||||||0.0242|||||||Kruskal-Wallis|||||||0.0242
74061447|NCT02072174|147674527|SUPERIORITY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||patient diary data||||0.0026
74061448|NCT02072174|147674527|SUPERIORITY|||||||0.0127|||||||Cochran-Mantel-Haenszel|||doctor's examination data||||0.0127
74061449|NCT02072174|147674528|SUPERIORITY|||||||0.0394||||||"The p-value associated with treatment factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate. Treatment\*visit interaction p-value is 0.3220."|Mixed Models Analysis|||||||0.0394
74061450|NCT02072174|147674528|SUPERIORITY|||||||0.322||||||"The p-value associated with treatment\*visit interaction factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate."|Mixed Models Analysis|||||||0.3220
74061451|NCT02072174|147674529|SUPERIORITY|||||||0.0043|||||||Cochran-Mantel-Haenszel|||||||0.0043
74061452|NCT02072174|147674530|SUPERIORITY|||||||0.0104||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 2 (patient diary data)||||0.0104
74102828|NCT00336024|147755235|SUPERIORITY|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.17
74102829|NCT00336024|147755235|SUPERIORITY|||||||0.3|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.3
74102830|NCT00336024|147755235|SUPERIORITY|||||||0.26|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.26
74102831|NCT00336024|147755235|SUPERIORITY|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.17
73888238|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.03|||<|0.0001|TWO_SIDED|95.0|-4.37|-3.69|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.69|-4.37|<0.0001
74061453|NCT02072174|147674530|SUPERIORITY|||||||0.0041||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (patient diary data)||||0.0041
73882302|NCT01183689|147298541|SUPERIORITY||Mean Difference (Net)|-2.42||||0.001|TWO_SIDED|95.0|-3.69|-1.14||The p-value is from a 2 degree of freedom F-test for differences among the 3 arms|ANOVA||The 95% confidence interval for differences between groups 1 and 3 does not include 0.|Mean change in waist girth from baseline to year 2||-1.14|-3.69|0.001
74061454|NCT02072174|147674530|SUPERIORITY|||||||0.0484||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 4 (patient diary data)||||0.0484
74061455|NCT02072174|147674530|SUPERIORITY|||||||0.0603||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (patient diary data)||||0.0603
74061456|NCT02072174|147674530|SUPERIORITY|||||||0.0056||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (doctor's examination)||||0.0056
74061457|NCT02072174|147674530|SUPERIORITY|||||||0.0994||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (doctor's examination)||||0.0994
74061458|NCT02072174|147674531|SUPERIORITY|||||||0.0084|||||||Kruskal-Wallis|||Days 1-7 (patient diary data)||||0.0084
73882303|NCT01183689|147298542|SUPERIORITY|Chi-squared test to compare the percentage of participants reporting self-weighing more than once per week among the 3 arms.|Odds Ratio (OR)|1.77||||0.004|TWO_SIDED|95.0|1.04|3.02||This is based on a 2 degree of freedom likelihood ratio test to compare differences among the 3 arms.|Regression, Logistic||The 95% confidence interval for the odds ratio comparing the rates of self-weighing at year 2 between groups 1 and 2 excludes 0.|Logistic regression to compare differences among the 3 groups||3.02|1.04|0.004
73882304|NCT01183689|147298542|SUPERIORITY||Odds Ratio (OR)|2.35||||0.004|TWO_SIDED|95.0|1.4|3.94||2 degree of freedom likelihood ratio statistic to compare differences among the 3 arms|Regression, Logistic|No adjustments|The 95% confidence interval for the odds ratio comparing groups 1 and 3 excludes 0.|Logistic regression analysis was used to compare the rates of daily self-weighing at 2 years among the 3 groups.||3.94|1.40|0.004
73882305|NCT01419236|147298544|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.38|TWO_SIDED|90.0|-0.59|1.91|||Mixed Models Repeated Measure Analysis|||||1.91|-0.59|0.380
74061459|NCT02072174|147674531|SUPERIORITY|||||||0.0233|||||||Kruskal-Wallis|||Days 1, 3, 5 and 7 (doctor's examination)||||0.0233
74061460|NCT02072174|147674532|SUPERIORITY|||||||0.0721|||||||Mixed Models Analysis|||||||0.0721
74061461|NCT02072174|147674533|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
74061462|NCT02072174|147674534|SUPERIORITY|||||||0.3383|||||||Fisher Exact|||||||0.3383
74061463|NCT05674721|147674536|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per Food and Drug Administration (FDA) requirements if the 90 percent (%) confidence intervals (CIs) for the ratio of the geometric means of Cmax were between 80% and 125%.|Ratio of Geometric Least Square Mean|95.13|||||TWO_SIDED|90.0|88.31|102.47||||||||102.47|88.31|
74061464|NCT05674721|147674537|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of Cmax were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.51|||||TWO_SIDED|90.0|93.54|112.35||||||||112.35|93.54|
74061465|NCT05674721|147674538|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-t were between 80% and 125%.|Ratio of Geometric Least Square Mean|99.15|||||TWO_SIDED|90.0|96.76|101.61||||||||101.61|96.76|
74061466|NCT05674721|147674539|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-t were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.62|||||TWO_SIDED|90.0|98.15|107.3||||||||107.30|98.15|
74061467|NCT05674721|147674540|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-inf were between 80% and 125%.|Ratio of Geometric Least Square Mean|99.2|||||TWO_SIDED|90.0|96.82|101.63||||||||101.63|96.82|
74061468|NCT05674721|147674541|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-inf were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.73|||||TWO_SIDED|90.0|98.31|107.34||||||||107.34|98.31|
74061469|NCT04466956|147674565|OTHER|Statistical analysis was by intention-to-treat including all randomised participants, using Stata-12 software. Continuous data were summarised as mean and standard deviation, and categorical data as counts and percentages. Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.|||||<|0.01|TWO_SIDED|95.0||||Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.|t-test, 1 sided|||Mean worst pain scores were 5.98 and 6.88 in the standard care and VR groups respectively, with difference in means -0.9 (95% CI -2.1 - 0.28), p value 0.13. Mean anxiety scores at the end of the procedure were 3.94 and 4.4 in the standard care and VR groups respectively, with difference in means -0.46 (95% CI -2.1, 1.1), p value 0.57.||||<0.01
74061470|NCT02643394|147674566|SUPERIORITY|||||||0.252|TWO_SIDED|80.0|||||Wilcoxon (Mann-Whitney)|||||||0.252
74061471|NCT02643394|147674567|SUPERIORITY|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||||||0.402
74061472|NCT03701516|147674569|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.|Posterior Mean Difference|-0.38|STANDARD_DEVIATION|1.781|||TWO_SIDED|98.0|-4.53|3.85|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||3.85|-4.53|
74061473|NCT03701516|147674570|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.|Posterior Mean Difference|-2.34|STANDARD_DEVIATION|1.263|||TWO_SIDED|98.0|-5.36|0.61|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.61|-5.36|
74061474|NCT03701516|147674571|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -1.|Posterior Mean Difference|-0.06|STANDARD_DEVIATION|0.083|||TWO_SIDED|95.0|-0.22|0.1|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.10|-0.22|
74061475|NCT03701516|147674572|NON_INFERIORITY|Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.|Posterior Mean Difference|0.001|STANDARD_DEVIATION|0.0028|||TWO_SIDED|95.0|-0.005|0.006|||Bayesian repeated measurement random-eff|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.006|-0.005|
74061476|NCT03701516|147674573|NON_INFERIORITY|Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.|Posterior Mean Difference|-0.003|STANDARD_DEVIATION|0.0029|||TWO_SIDED|95.0|-0.009|0.002|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.002|-0.009|
73882306|NCT01419236|147298545|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44||||0.164|TWO_SIDED|90.0|-0.96|0.08|||Mixed Models Repeated Measures Analysis|||||0.08|-0.96|0.164
74061477|NCT03083639|147674574|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUC∞ using analysis of variance (ANOVA) models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90 percent (%) confidence intervals (CIs) for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|1.018|||||TWO_SIDED|90.0|0.969|1.07||||||||1.070|0.969|
74061478|NCT03083639|147674575|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUCt using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|0.993|||||TWO_SIDED|90.0|0.939|1.05||||||||1.050|0.939|
74061479|NCT03083639|147674576|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of Cmax using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of Cmax central values between esomeprazole capsules and tablets are presented.|Point estimate|0.942|||||TWO_SIDED|90.0|0.88|1.009||||||||1.009|0.880|
74061480|NCT03940742|147674620|OTHER||Ratio of geometric least squares mean|1.08|||||TWO_SIDED|90.0|0.879|1.32||||||||1.32|0.879|
74061481|NCT03940742|147674620|OTHER||Ratio of geometric least squares mean|0.96|||||TWO_SIDED|90.0|0.79|1.17||||||||1.17|0.790|
74061482|NCT03940742|147674620|OTHER||Ratio of geometric least squares mean|0.852|||||TWO_SIDED|90.0|0.699|1.04||||||||1.04|0.699|
74061483|NCT03940742|147674621|OTHER||Ratio of geometric least squares mean|0.916|||||TWO_SIDED|90.0|0.726|1.16||||||||1.16|0.726|
74061484|NCT03940742|147674621|OTHER||Ratio of geometric least squares mean|1.0|||||TWO_SIDED|90.0|0.802|1.25||||||||1.25|0.802|
74061485|NCT03940742|147674621|OTHER||Ratio of geometric least squares mean|0.972|||||TWO_SIDED|90.0|0.784|1.21||||||||1.21|0.784|
74061486|NCT02032823|147674622|SUPERIORITY||Hazard Ratio (HR)|0.581||||7.3e-06|TWO_SIDED|99.5|0.409|0.816||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.816|0.409|0.0000073
74061487|NCT02032823|147674623|SUPERIORITY||Hazard Ratio (HR)|0.574||||2.57e-05|TWO_SIDED|99.5|0.392|0.831||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.831|0.392|0.0000257
74061488|NCT02032823|147674624|SUPERIORITY||Hazard Ratio (HR)|0.678||||0.0091|TWO_SIDED|98.5|0.468|0.973||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.973|0.468|0.0091
74061489|NCT03428217|147674630|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6528|TWO_SIDED|95.0|0.74|1.21|||Log Rank|||Stratified Analysis 1: Stratified by prior programmed cell death protein 1/programmed cell death protein ligand 1 (PD-1/PDL1) inhibitor therapy (yes vs no) and International Metastatic Renal Cell Carcinoma Database (IMDC) prognostic risk group (favorable vs intermediate vs poor).||1.21|0.74|0.6528
74061490|NCT03428217|147674630|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8193|TWO_SIDED|95.0|0.76|1.24|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.24|0.76|0.8193
74061491|NCT03428217|147674630|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8345|TWO_SIDED|95.0|0.76|1.25|||Log Rank|||Stratified Analysis 3: Stratified by the number of prior anti-angio cancer therapy \[0 vs. \>=1\].||1.25|0.76|0.8345
74061492|NCT03428217|147674630|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9479|TWO_SIDED|95.0|0.78|1.27|||Log Rank|||Unstratified Analysis||1.27|0.78|0.9479
74061493|NCT03428217|147674631|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3867|TWO_SIDED|95.0|0.83|1.6|||Log Rank|||Stratified Analysis 1: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate vs. poor\].||1.6|0.83|0.3867
74061494|NCT03428217|147674631|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.3367|TWO_SIDED|95.0|0.85|1.62|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.62|0.85|0.3367
74061495|NCT03428217|147674631|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.2416|TWO_SIDED|95.0|0.88|1.69|||Log Rank|||Stratified Analysis 3: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.69|0.88|0.2416
74061496|NCT03428217|147674631|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.3043|TWO_SIDED|95.0|0.86|1.64|||Log Rank|||Unstratified Analysis||1.64|0.86|0.3043
74061497|NCT03428217|147674632|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9692|TWO_SIDED|95.0|0.79|1.25|||Log Rank|||Stratified Analysis 1: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate vs. poor\].||1.25|0.79|0.9692
74061498|NCT03428217|147674632|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9235|TWO_SIDED|95.0|0.8|1.27|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.27|0.8|0.9235
74061499|NCT03428217|147674632|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9549|TWO_SIDED|95.0|0.8|1.26|||Log Rank|||Stratified Analysis 3: Stratified by the number of prior anti-angio cancer therapy \[0 vs. \>=1\].||1.26|0.8|0.9549
74061500|NCT03428217|147674632|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8193|TWO_SIDED|95.0|0.82|1.29|||Log Rank|||Unstratified Analysis||1.29|0.82|0.8193
74061501|NCT03889197|147674633|SUPERIORITY|||||||0.162|||||||Kruskal-Wallis|||||||0.162
74061502|NCT03889197|147674634|SUPERIORITY|||||||0.242|||||||Kruskal-Wallis|||||||0.242
74061503|NCT03889197|147674635|SUPERIORITY|||||||0.956|||||||Kruskal-Wallis|||||||0.956
74061504|NCT03889197|147674636|SUPERIORITY|||||||0.132|||||||Kruskal-Wallis|||||||0.132
74061505|NCT03889197|147674637|SUPERIORITY|||||||0.445|||||||Kruskal-Wallis|||||||0.445
74061506|NCT03889197|147674638|SUPERIORITY|||||||0.746|||||||Kruskal-Wallis|||||||0.746
74061507|NCT03889197|147674639|SUPERIORITY|||||||0.979|||||||Kruskal-Wallis|||||||0.979
74061508|NCT03889197|147674640|SUPERIORITY|||||||0.289|||||||Chi-squared|||||||0.289
74061509|NCT03889197|147674641|SUPERIORITY|||||||0.94|||||||Kruskal-Wallis|||||||0.940
74061510|NCT03889197|147674642|SUPERIORITY|||||||0.126|||||||Chi-squared|||||||0.126
74061511|NCT03889197|147674643|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
74061512|NCT03889197|147674644|SUPERIORITY|||||||0.676|||||||Fisher Exact|||||||0.676
74061513|NCT03889197|147674645|SUPERIORITY|||||||0.996|||||||Kruskal-Wallis|||||||0.996
74061514|NCT03889197|147674646|SUPERIORITY|||||||0.095|||||||Kruskal-Wallis|||||||0.095
74061515|NCT02038959|147674687|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANCOVA|||||||>0.05
74061516|NCT02038959|147674692|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74061517|NCT00819091|147674727|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-0.7|-0.24|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||-0.24|-0.70|< 0.0001
74061518|NCT00819091|147674728|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|5.5||0.2406||95.0|-17.2|4.3|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||4.3|-17.2|0.2406
74061519|NCT00819091|147674729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.466||||0.0065||95.0|1.684|24.825|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||24.825|1.684|0.0065
74061520|NCT00819091|147674730|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.653||||0.2431||95.0|0.515|13.652|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||13.652|0.515|0.2431
74061521|NCT00819091|147674731|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.125||||0.0001||95.0|2.747|9.562|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||9.562|2.747|0.0001
74061522|NCT00819091|147674732|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|||<|0.0001||95.0|-0.585|-0.23|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.230|-0.585|<0.0001
74061523|NCT00819091|147674733|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||<|0.0001||95.0|-0.72|-0.276|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.276|-0.720|<0.0001
74061524|NCT00819091|147674734|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47||||0.0002||95.0|-0.716|-0.226|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.226|-0.716|0.0002
74061525|NCT00819091|147674735|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|4.6||0.197||95.0|-14.9|3.1|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||3.1|-14.9|0.197
74061526|NCT00819091|147674736|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|5.6||0.0105||95.0|-25.5|-3.4|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||-3.4|-25.5|0.0105
74061527|NCT00467038|147674737|SUPERIORITY_OR_OTHER||||||<|0.004|TWO_SIDED||||||t-test, 1 sided|\<0.004 p value was common for all time points.||||||<0.004
74061528|NCT00467038|147674738|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Fisher's LSD post-hoc, trend level|||||||0.08
74061529|NCT00367679|147674739|SUPERIORITY_OR_OTHER||Percentage of participants with response|5.7||||||95.0|0.7|19.2|||||The estimated value given is the percentage of participants who had a response out of the total participants.|||19.2|0.7|
74061530|NCT00367679|147674740|SUPERIORITY_OR_OTHER||Percentage of participants with response|8.6||||||95.0|1.8|23.1|||||The estimated value given is the percentage of participants who had a response out of the total participants.|||23.1|1.8|
74061531|NCT00367679|147674746|SUPERIORITY_OR_OTHER|||||||0.0028||95.0||||VEGF D|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0028
74061532|NCT00367679|147674746|SUPERIORITY_OR_OTHER|||||||0.0324||95.0||||VEGF A|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0324
74061533|NCT00367679|147674746|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||VEGFR-2|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0082
74061534|NCT00367679|147674746|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||c-KIT|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0082
74061535|NCT00367679|147674752|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Vascular endothelial growth factor receptor 2 (VEGFR2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||<0.01
74061536|NCT00367679|147674752|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Placental growth factor (PIGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||<0.01
74061537|NCT00367679|147674752|SUPERIORITY_OR_OTHER|||||||0.00024||95.0||||Interferon-inducible cytokine (IP-10)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.00024
74061538|NCT00367679|147674752|SUPERIORITY_OR_OTHER|||||||0.0029||95.0||||Cutaneous T-cell attracting chemokine (CTACK)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0029
74061539|NCT00367679|147674752|SUPERIORITY_OR_OTHER|||||||0.0062||95.0||||Stromal cell-derived factor 1 (SDF-1alpha)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0062
74061540|NCT00367679|147674752|SUPERIORITY_OR_OTHER|||||||0.0069||95.0||||Monokine induced by interferon gamma (MIG)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0069
74061541|NCT00367679|147674752|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||Tumor necrosis factor ligand (TRAIL)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0093
74061542|NCT00367679|147674752|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Interferon alpha 2 (IFN-alpha2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.021
74061543|NCT00367679|147674752|SUPERIORITY_OR_OTHER|||||||0.326||95.0||||Vascular endothelial growth factor (VEGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.326
74061544|NCT01787188|147674784|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.84|STANDARD_ERROR_OF_MEAN|3.097||0.0005|TWO_SIDED|95.0|-16.93|-4.75|||Mixed Models Analysis|||||-4.75|-16.93|0.0005
74061545|NCT01787188|147674784|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.74|STANDARD_ERROR_OF_MEAN|3.154||0.0059|TWO_SIDED|95.0|-14.94|-2.53|||Mixed Models Analysis|||||-2.53|-14.94|0.0059
74061546|NCT01787188|147674785|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.61|STANDARD_ERROR_OF_MEAN|2.641||0.0003|TWO_SIDED|95.0|-14.8|-4.42|||Mixed Models Analysis|||||-4.42|-14.80|0.0003
74061547|NCT01787188|147674785|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.9|STANDARD_ERROR_OF_MEAN|2.696||0.1486|TWO_SIDED|95.0|-9.2|1.4|||Mixed Models Analysis|||||1.40|-9.20|0.1486
74061548|NCT01787188|147674786|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.33|STANDARD_ERROR_OF_MEAN|2.865||0.0004|TWO_SIDED|95.0|-15.97|-4.7|||Mixed Models Analysis|||||-4.70|-15.97|0.0004
74061549|NCT01787188|147674786|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.84|STANDARD_ERROR_OF_MEAN|2.917||0.0008|TWO_SIDED|95.0|-15.58|-4.1|||Mixed Models Analysis|||||-4.10|-15.58|0.0008
74061550|NCT01787188|147674787|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.44|STANDARD_ERROR_OF_MEAN|2.521|<|0.0001|TWO_SIDED|95.0|-15.4|-5.48|||ANCOVA|||||-5.48|-15.40|<0.0001
74061551|NCT01787188|147674787|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.82|STANDARD_ERROR_OF_MEAN|2.561||0.0024|TWO_SIDED|95.0|-12.85|-2.78|||ANCOVA|||||-2.78|-12.85|0.0024
74061552|NCT01787188|147674788|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.34|STANDARD_ERROR_OF_MEAN|2.623|<|0.0001|TWO_SIDED|95.0|-15.49|-5.18|||Mixed Models Analysis|||||-5.18|-15.49|<0.0001
74061553|NCT01787188|147674788|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.39|STANDARD_ERROR_OF_MEAN|2.662||0.0997|TWO_SIDED|95.0|-9.63|0.84|||Mixed Models Analysis|||||0.84|-9.63|0.0997
74061554|NCT01787188|147674789|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.83|STANDARD_ERROR_OF_MEAN|2.905||0.0008|TWO_SIDED|95.0|-15.54|-4.11|||Mixed Models Analysis|||||-4.11|-15.54|0.0008
73882307|NCT01419236|147298546|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.342|TWO_SIDED|90.0|-0.31|1.15|||Mixed Models Repeated Measure Analysis|||||1.15|-0.31|0.342
74061555|NCT01787188|147674789|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.42|STANDARD_ERROR_OF_MEAN|2.951||0.0015|TWO_SIDED|95.0|-15.22|-3.62|||Mixed Models Analysis|||||-3.62|-15.22|0.0015
74061556|NCT01787188|147674790|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.13|STANDARD_ERROR_OF_MEAN|3.147||0.0014|TWO_SIDED|95.0|-16.32|-3.94|||Mixed Models Analysis|||||-3.94|-16.32|0.0014
74061557|NCT01787188|147674790|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.98|STANDARD_ERROR_OF_MEAN|3.198||0.0019|TWO_SIDED|95.0|-16.27|-3.69|||Mixed Models Analysis|||||-3.69|-16.27|0.0019
74061558|NCT01787188|147674791|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.47|STANDARD_ERROR_OF_MEAN|2.593|<|0.0001|TWO_SIDED|95.0|-15.57|-5.37|||ANCOVA|||||-5.37|-15.57|<0.0001
74061559|NCT01787188|147674791|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.16|STANDARD_ERROR_OF_MEAN|2.627||0.002|TWO_SIDED|95.0|-13.33|-2.99|||ANCOVA|||||-2.99|-13.33|0.0020
74061560|NCT01787188|147674792|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.45|STANDARD_ERROR_OF_MEAN|2.686||0.0001|TWO_SIDED|95.0|-15.73|-5.17|||Mixed Models Analysis|||||-5.17|-15.73|0.0001
73882308|NCT01419236|147298547|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.079|TWO_SIDED|90.0|0.05|1.57|||Mixed Models Repeated Measure Analysis|||||1.57|0.05|0.079
73882309|NCT01419236|147298548|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.535|TWO_SIDED|90.0|-0.5|1.1|||Mixed Models Repeated Measure Analysis|||||1.10|-0.50|0.535
74061561|NCT01787188|147674792|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.41|STANDARD_ERROR_OF_MEAN|2.725||0.1065|TWO_SIDED|95.0|-9.77|0.95|||Mixed Models Analysis|||||0.95|-9.77|0.1065
74061562|NCT01787188|147674793|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.68|STANDARD_ERROR_OF_MEAN|2.961||0.0012|TWO_SIDED|95.0|-15.5|-3.85|||Mixed Models Analysis|||||-3.85|-15.50|0.0012
74061563|NCT01787188|147674793|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.65|STANDARD_ERROR_OF_MEAN|3.006||0.0014|TWO_SIDED|95.0|-15.56|-3.74|||Mixed Models Analysis|||||-3.74|-15.56|0.0014
74061564|NCT01787188|147674794|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.26|STANDARD_ERROR_OF_MEAN|3.194||0.0014|TWO_SIDED|95.0|-16.54|-3.97|||Mixed Models Analysis|||||-3.97|-16.54|0.0014
74061565|NCT01787188|147674794|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.45|STANDARD_ERROR_OF_MEAN|3.24||0.0014|TWO_SIDED|95.0|-16.82|-4.08|||Mixed Models Analysis|||||-4.08|-16.82|0.0014
74061566|NCT01787188|147674795|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.52|STANDARD_ERROR_OF_MEAN|2.646|<|0.0001|TWO_SIDED|95.0|-15.72|-5.31|||ANCOVA|||||-5.31|-15.72|<0.0001
74061567|NCT01787188|147674795|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.44|STANDARD_ERROR_OF_MEAN|2.68||0.0018|TWO_SIDED|95.0|-13.71|-3.17|||ANCOVA|||||-3.17|-13.71|0.0018
74061568|NCT01787188|147674796|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.98|STANDARD_ERROR_OF_MEAN|2.831||0.0001|TWO_SIDED|95.0|-16.55|-5.41|||Mixed Models Analysis|||||-5.41|-16.55|0.0001
74061569|NCT01787188|147674796|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.02|STANDARD_ERROR_OF_MEAN|2.89||0.0379|TWO_SIDED|95.0|-11.71|-0.34|||Mixed Models Analysis|||||-0.34|-11.71|0.0379
74061570|NCT01787188|147674797|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.22|STANDARD_ERROR_OF_MEAN|3.152||0.0001|TWO_SIDED|95.0|-18.42|-6.02|||Mixed Models Analysis|||||-6.02|-18.42|0.0001
74061571|NCT01787188|147674797|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.1|STANDARD_ERROR_OF_MEAN|3.21||0.0049|TWO_SIDED|95.0|-15.41|-2.78|||Mixed Models Analysis|||||-2.78|-15.41|0.0049
74061572|NCT01787188|147674798|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.94|STANDARD_ERROR_OF_MEAN|3.359||0.0012|TWO_SIDED|95.0|-17.55|-4.33|||Mixed Models Analysis|||||-4.33|-17.55|0.0012
74061573|NCT01787188|147674798|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.36|STANDARD_ERROR_OF_MEAN|3.422||0.0066|TWO_SIDED|95.0|-16.09|-2.63|||Mixed Models Analysis|||||-2.63|-16.09|0.0066
74061574|NCT01787188|147674799|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-11.67|STANDARD_ERROR_OF_MEAN|2.751|<|0.0001|TWO_SIDED|95.0|-17.08|-6.26|||ANCOVA|||||-6.26|-17.08|<0.0001
73882310|NCT01419236|147298549|SUPERIORITY_OR_OTHER||LS Mean Difference|1.03||||0.172|TWO_SIDED|90.0|-0.22|2.27|||ANCOVA|||||2.27|-0.22|0.172
73882311|NCT01419236|147298550|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.473|TWO_SIDED|90.0|-0.41|1.04|||Mixed Models Repeated Measure Analysis|||||1.04|-0.41|0.473
73882312|NCT01419236|147298551|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.885|TWO_SIDED|90.0|-1.03|0.87|||Mixed Models Repeated Measure Analysis|||||0.87|-1.03|0.885
73882313|NCT01419236|147298552|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.938|TWO_SIDED|90.0|-0.61|0.55|||Mixed Models Repeated Measure Analysis|||||0.55|-0.61|0.938
73882314|NCT02250326|147298553|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|1.94||||Based on stratification factors of ECOG Performance Status (0 or 1), sex (male or female), and current smoker status (yes or no).||Based on stratified Cox proportional hazards regression model.||1.94|0.90|
73882315|NCT02250326|147298554|SUPERIORITY||Disease Control Rate Ratio|0.97|||||TWO_SIDED|95.0|0.778|1.207|||||95% CI was calculated using Clopper-Pearson method.||Direction of Disease Control Rate Ratio is DCR of Nab-Paclitaxel + CC-486 Combination Arm over DCR of Nab-Paclitaxel Alone|1.207|0.778|
74061575|NCT01787188|147674799|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.24|STANDARD_ERROR_OF_MEAN|2.795||0.0034|TWO_SIDED|95.0|-13.74|-2.74|||ANCOVA|||||-2.74|-13.74|0.0034
74061576|NCT02756078|147674827|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|5.0|STANDARD_DEVIATION|1.796|||TWO_SIDED|98.0|1.3|8.73|||Bayesian hierarchical model|A 98% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)|||8.73|1.30|
74061577|NCT02756078|147674828|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|13.7|STANDARD_DEVIATION|1.701|||TWO_SIDED|95.0|10.34|17.05|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)|||17.05|10.34|
74061578|NCT02756078|147674829|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.37|STANDARD_DEVIATION|0.313|||TWO_SIDED|95.0|-1.0|0.25|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|||Mean difference was calculated as senofilcon A minus samfilcon A.|0.25|-1.00|
74061579|NCT02756078|147674830|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.06|STANDARD_DEVIATION|0.107|||TWO_SIDED|95.0|-0.27|0.16|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A|||0.16|-0.27|
74061580|NCT02756078|147674831|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|0.05|STANDARD_DEVIATION|0.261|||TWO_SIDED|95.0|-0.47|0.57|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A|||0.57|-0.47|
74061581|NCT02756078|147674832|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.05|STANDARD_DEVIATION|0.159|||TWO_SIDED|95.0|-0.36|0.26|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A.|||0.26|-0.36|
74061582|NCT02756078|147674833|NON_INFERIORITY|A non-inferiority margin of 0.67 was used.|Posterior odds ratio|1.35|STANDARD_DEVIATION|0.203|||TWO_SIDED|95.0|0.99|1.79|||Bayesian multinomial model|A 95% credible interval for the posterior odds ratio was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Odds ratio was calculated as senofilcon A over samfilcon A.|||1.79|0.99|
73882316|NCT02250326|147298555|SUPERIORITY||Overall Response Rate Ratio|0.84|||||TWO_SIDED|95.0|0.398|1.754|||||95% CI was calculated using Clopper-Pearson method.||Direction of Overall Response Rate Ratio is ORR of Nab-Paclitaxel + CC-486 Combination Arm over ORR of nab-Paclitaxel Alone.|1.754|0.398|
74061583|NCT02180659|147674857|NON_INFERIORITY|"For the primary efficacy variable, a test of non-inferiority of Probuphine (active) versus SL BPN (control) responders was conducted. A non-inferiority margin of 20% was employed to define noninferiority.~A Confidence Interval (CI) for the difference in proportions was calculated, and non-inferiority was established if the lower bound of the 95% CI for the difference of proportions (Probuphine - SL BPN) was greater than -0.20."|Difference in Response Rate|0.088|||<|0.001|TWO_SIDED|95.0|0.009|0.167|||Chi-squared|||||0.167|0.009|<.001
74061584|NCT02180659|147674858|SUPERIORITY|At month 6 comparing those subject with no illicit drug use.||||||0.306|||||||Chi-squared|||||||0.306
74061585|NCT02180659|147674859|SUPERIORITY|||||||0.037|||||||Log Rank|||||||.037
74061586|NCT02180659|147674861|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.832|TWO_SIDED||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.||||0.832
74061587|NCT02180659|147674862|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.922|TWO_SIDED||||||ANOVA|||||||0.922
74061588|NCT02180659|147674863|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.425|TWO_SIDED||||||ANOVA|||||||0.425
74061589|NCT02180659|147674864|SUPERIORITY||Median Difference (Final Values)|-1.3||||0.505|TWO_SIDED||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.||||0.505
74061590|NCT02587117|147674873|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|95.0|||||Mann Whitney test|||||||0.004
74061591|NCT02587117|147674874|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED|95.0|||||Mann Whitney test|||||||0.224
74061592|NCT03332212|147674880|OTHER||Mean Difference (Final Values)|-0.247|STANDARD_ERROR_OF_MEAN|0.164||0.1418|TWO_SIDED|95.0|-0.582|0.087|||ANOVA|||ANOVA on the PCr/ATP ratio absolute change using treatment (empagliflozin vs. placebo), history of diabetes (yes vs, no) and history of atrial fibrillation (yes vs no) as between subjects factor.||0.087|-0.582|0.1418
74061593|NCT03332212|147674880|OTHER||Mean Difference (Final Values)|-0.159|STANDARD_ERROR_OF_MEAN|0.213||0.465|TWO_SIDED|95.0|-0.604|0.286|||ANOVA|||ANOVA on the PCr/ATP ratio absolute change using treatment (empagliflozin vs. placebo), history of diabetes (yes vs, no) and history of atrial fibrillation (yes vs no) as between subjects factor.||0.286|-0.604|0.4650
74061594|NCT00609115|147674881|SUPERIORITY||Effect size|0.65||||0.01|TWO_SIDED|97.5|||||ANCOVA|||||||0.010
74061595|NCT00609115|147674881|SUPERIORITY||Effect|0.71||||0.003|TWO_SIDED|95.0|||||ANCOVA|||||||0.003
74061596|NCT00609115|147674882|SUPERIORITY||Effect Size|0.0||||1|TWO_SIDED|95.0||||The reported p-value was calculated.|ANCOVA|||||||1.00
74061597|NCT00609115|147674882|SUPERIORITY||Effect Size|-0.29||||0.06|TWO_SIDED|95.0|||||ANCOVA|||||||0.06
74061598|NCT00609115|147674883|SUPERIORITY||Effect Size|0.33||||0.17|TWO_SIDED|95.0|||||ANCOVA|||||||0.17
74061599|NCT00609115|147674883|SUPERIORITY||Effect Size|0.4||||0.17|TWO_SIDED|95.0|||||ANCOVA|||||||0.17
74061600|NCT00609115|147674884|SUPERIORITY||Effect Size|0.05||||0.83|TWO_SIDED|95.0|||||ANCOVA|||||||0.83
74061601|NCT00609115|147674884|SUPERIORITY||Effect Size|-0.27||||0.83|TWO_SIDED|95.0|||||ANCOVA|||||||0.83
74061602|NCT00609115|147674885|SUPERIORITY||Effect Size|0.25||||0.28|TWO_SIDED|95.0|||||ANCOVA|||||||0.28
74061603|NCT00609115|147674885|SUPERIORITY||Effect Size|0.38||||0.09|TWO_SIDED|95.0|||||ANCOVA|||||||0.09
74061604|NCT00609115|147674886|SUPERIORITY||Effect Size|0.23||||0.18|TWO_SIDED|95.0|||||ANCOVA|||||||0.18
74061605|NCT00609115|147674886|SUPERIORITY||Effect Size|0.37||||0.1|TWO_SIDED|95.0|||||ANCOVA|||||||0.10
74061606|NCT00609115|147674887|SUPERIORITY||Effect Size|0.18||||0.45|TWO_SIDED|95.0|||||ANCOVA|||||||0.45
74061607|NCT00609115|147674887|SUPERIORITY||Effect Size|0.71||||0.003|TWO_SIDED|95.0|||||ANCOVA|||||||0.003
74061608|NCT00609115|147674888|SUPERIORITY||Effect Size|-0.17||||0.47|TWO_SIDED|95.0|||||ANCOVA|||||||0.47
74061609|NCT00609115|147674888|SUPERIORITY||Effect Size|0.77||||0.015|TWO_SIDED|95.0|||||ANCOVA|||||||0.015
74061610|NCT00609115|147674889|SUPERIORITY||Effect Size|0.48||||0.05|TWO_SIDED|95.0|||||ANCOVA|||||||0.05
74061611|NCT00609115|147674889|SUPERIORITY||Effect Size|0.56||||0.002|TWO_SIDED|95.0|||||ANCOVA|||||||0.002
74061612|NCT00609115|147674890|SUPERIORITY||Effect Size|0.26||||0.27|TWO_SIDED|95.0|||||ANCOVA|||||||0.27
74061613|NCT00609115|147674890|SUPERIORITY||Effect Size|0.45||||0.045|TWO_SIDED|95.0|||||ANCOVA|||||||0.045
74061614|NCT02125734|147674891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.081||||0.0017|TWO_SIDED|95.0|0.031|0.13|||ANCOVA|||||0.130|0.031|0.0017
74061615|NCT00929864|147674906|NON_INFERIORITY_OR_EQUIVALENCE|Analysis tested for non-inferiority. Abatacept will be considered non-inferior to adalimumab if the upper limit of the 95% two-sided CI of difference in ACR20 response rates between the adalimumab arm and the abatacept arm is smaller than or equal to 12%. Estimate and 95% confidence interval (CI) for difference based on minimum risk weights method with randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).|Difference from adalimumab at Day 365|1.8|||||TWO_SIDED|95.0|-5.6|9.2|||minimum risk weights method|adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||The null and alternative hypotheses are H0: T - C\<= δ vs. Ha:T - C \> δ, where T is the treatment effect of abatacept, C is the effect of active control (adalimumab),and δ is non-inferiority margin. Abatacept is defined as δ non-inferior to adalimumab when H0 is rejected. More specifically, if the lower bound of the 95% two-sided confidence interval for C-T is greater than δ,, then that Abatacept is δ non-inferior to adalimumab can be claimed.||9.2|-5.6|
74061616|NCT00929864|147674907|SUPERIORITY_OR_OTHER||Difference in proportions|-5.37||||0.006|TWO_SIDED|95.0|-9.13|-1.62|||Chi-squared|||Analysis is p-value of difference in proportions. n=number of participants with event, N=number of participants at risk. Proportion = n/N. In order to maintain the overall type I error rate of 0.05 for testing both the primary non-inferiority hypothesis and the key secondary local injection site reaction (LISR) hypothesis, the LISR hypothesis was tested at the 5% significance level only after the primary non-inferiority hypothesis is established at the 5% level.||-1.62|-9.13|0.006
74061617|NCT00929864|147674908|SUPERIORITY_OR_OTHER||Difference from adalimumab|-4.13|||||TWO_SIDED|95.0|-6.55|-1.72||||||Analysis of incidence rate at 24 months. Point estimate and 95% CI. Poisson distribution was used to construct the 95% CIs.||-1.72|-6.55|
74061618|NCT00929864|147674909|SUPERIORITY_OR_OTHER||Difference from adalimumab at Day 365|-1.3|||||TWO_SIDED|95.0|-6.5|3.9|||minimum risk weights method|Adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||This analysis is for Day 365.||3.9|-6.5|
74061619|NCT00929864|147674909|SUPERIORITY_OR_OTHER||Difference from adalimumab at Day 729|0.9|||||TWO_SIDED|95.0|-5.5|7.3|||minimum risk weights method|Adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||This analysis is for Day 729.||7.3|-5.5|
74061620|NCT00929864|147674910|SUPERIORITY_OR_OTHER||Difference from adalimumab|0.8|||||TWO_SIDED|95.0|-4.51|6.11||||||Analysis for incidence rate of SAE at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||6.11|-4.51|
74061621|NCT00929864|147674910|SUPERIORITY_OR_OTHER||Difference from adalimumab|-0.67|||||TWO_SIDED|95.0|-3.27|1.94||||||Analysis for incidence rate of Serious Infections and Infestations at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.94|-3.27|
74061622|NCT00929864|147674910|SUPERIORITY_OR_OTHER||Difference from adalimumab|0.0|||||TWO_SIDED|95.0|-0.92|0.91||||||Analysis for incidence rate of Opportunistic Infections at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.91|-0.92|
74061623|NCT00929864|147674910|SUPERIORITY_OR_OTHER||Difference from adalimumab|-5.32|||||TWO_SIDED|95.0|-12.06|1.41||||||Analysis for incidence rate of discontinuation for any cause at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.41|-12.06|
74061624|NCT00929864|147674911|SUPERIORITY_OR_OTHER||Difference from adalimumab|-1.91|||||TWO_SIDED|95.0|-5.43|1.61||||||Analysis for incidence rate of SAE at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.61|-5.43|
74061625|NCT00929864|147674911|SUPERIORITY_OR_OTHER||Difference from adalimumab|-1.24|||||TWO_SIDED|95.0|-3.12|0.63||||||Analysis for incidence rate of Serious infections and infestations Adverse Events at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.63|-3.12|
74061626|NCT00929864|147674911|SUPERIORITY_OR_OTHER||Difference from adalimumab|-0.52|||||TWO_SIDED|95.0|-1.39|0.36|||minimum risk weights method|||Analysis for incidence rate of opportunistic infections at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.36|-1.39|
74061627|NCT00929864|147674911|SUPERIORITY_OR_OTHER||Difference from adalimumab|-3.1|||||TWO_SIDED|95.0|-7.13|0.92||||||Analysis for incidence rate of discontinuations (all cause) at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.92|-7.13|
74061628|NCT00929864|147674912|SUPERIORITY_OR_OTHER||Difference from adalimumab|-8.1|||||TWO_SIDED|95.0|-13.9|-2.2||||||Analysis for ANA at Day 365. Point estimate and 95% CI for treatment difference.||-2.2|-13.9|
73882317|NCT02250326|147298556|SUPERIORITY||Hazard Ratio (HR)|1.7|||||TWO_SIDED|95.0|1.08|2.57||||Based on stratification factors of ECOG performance status (0 or 1), sex (male or female), and current smoker status (yes or no).||Based on stratified Cox proportional hazards regression model.||2.57|1.08|
73882318|NCT03585660|147298564|SUPERIORITY|||||||0.02|||||||bootstrap z-test|The standard error of the difference in accuracy was estimated using nonparametric bootstrap, with B=9999 resamples.||The null hypothesis is that the accuracy of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the accuracy of HM-MRI is greater than the accuracy of mp-MRI.||||0.02
74061629|NCT00929864|147674912|SUPERIORITY_OR_OTHER||Difference from adalimumab|-8.4|||||TWO_SIDED|95.0|-15.3|-1.5||||||Analysis for ANA at Day 729. Point estimate and 95% CI for treatment difference||-1.5|-15.3|
74061630|NCT00929864|147674912|SUPERIORITY_OR_OTHER||Difference from adalimumab|-9.6|||||TWO_SIDED|95.0|-13.4|-5.7||||||Analysis for dsDNA at Day 365. Point estimate and 95% CI for treatment difference.||-5.7|-13.4|
74061631|NCT00929864|147674912|SUPERIORITY_OR_OTHER||Difference from adalimumab|-12.2|||||TWO_SIDED|95.0|-16.9|-7.6||||||Analysis for dsDNA at Day 729. Point estimate and 95% CI for treatment difference.||-7.6|-16.9|
74061632|NCT02304302|147674915|SUPERIORITY||Mean Difference (Net)|0.34||||0.61|TWO_SIDED|95.0|-0.98|1.67|||Mixed Models Analysis|||||1.67|-0.98|0.61
74061633|NCT02304302|147674916|SUPERIORITY||Mean Difference (Net)|-0.32||||0.57|TWO_SIDED|95.0|-1.43|0.8|||Mixed Models Analysis|||||0.80|-1.43|0.57
74061634|NCT02304302|147674917|SUPERIORITY||Median Difference (Net)|-0.04||||0.91|TWO_SIDED|95.0|-0.74|0.66|||Mixed Models Analysis|||||0.66|-0.74|0.91
74061635|NCT02304302|147674918|SUPERIORITY||Median Difference (Final Values)|-0.5||||0.48|TWO_SIDED|95.0|-1.91|0.91|||Mixed Models Analysis|||||0.91|-1.91|0.48
74061636|NCT02304302|147674919|SUPERIORITY||Mean Difference (Net)|-1.31||||0.5|TWO_SIDED|95.0|-5.14|2.53|||Mixed Models Analysis|||||2.53|-5.14|0.50
74061637|NCT02304302|147674920|SUPERIORITY||Mean Difference (Net)|-0.1||||0.62|TWO_SIDED|95.0|-0.52|0.32|||Mixed Models Analysis|||||0.32|-0.52|0.62
74061638|NCT02304302|147674921|SUPERIORITY||Mean Difference (Net)|2.94||||0.84|TWO_SIDED|95.0|-25.32|31.2|||Mixed Models Analysis|||||31.20|-25.32|0.84
74061639|NCT02304302|147674922|SUPERIORITY||Mean Difference (Net)|-3.04||||0.24|TWO_SIDED|95.0|||||ANOVA|||QTc interval duration was the independent variable, treatment and time were the categorical factors.||||0.24
74061640|NCT02304302|147674923|SUPERIORITY||Mean Difference (Net)|1.91||||0.28|TWO_SIDED|95.0|-1.57|5.39|||Mixed Models Analysis|||||5.39|-1.57|0.28
74061641|NCT02304302|147674924|SUPERIORITY||Mean Difference (Net)|0.4||||0.51|TWO_SIDED|95.0|-0.8|1.61|||Mixed Models Analysis|||||1.61|-0.80|0.51
74061642|NCT02304302|147674925|SUPERIORITY||Mean Difference (Net)|1.17||||0.63|TWO_SIDED|95.0|-3.6|5.94|||Mixed Models Analysis|||||5.94|-3.6|0.63
74061643|NCT02304302|147674926|SUPERIORITY||Mean Difference (Net)|-3.65||||0.17|TWO_SIDED|95.0|-8.91|1.61|||Mixed Models Analysis|||||1.61|-8.91|0.17
74061644|NCT02392559|147674949|SUPERIORITY||treatment difference|-38.3|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-45.54|-31.06|||repeated measures model||Treatment difference uses placebo as the reference.|||-31.06|-45.54|< 0.0001
74061645|NCT02392559|147674949|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
74061646|NCT02392559|147674950|SUPERIORITY||treatment difference|-42.09|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|-48.34|-35.83|||repeated measures model||Treatment difference uses placebo as the reference.|||-35.83|-48.34|< 0.0001
74061647|NCT02392559|147674950|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
74061648|NCT02392559|147674951|SUPERIORITY||treatment difference|-68.6|STANDARD_ERROR_OF_MEAN|7.3|<|0.0001|TWO_SIDED|95.0|-83.1|-54.0||Treatment difference uses placebo as the reference.|repeated measures model|||||-54.0|-83.1|< 0.0001
74061649|NCT02392559|147674951|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
74061650|NCT02392559|147674952|SUPERIORITY||treatment difference|-35.04|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-41.79|-28.3|||repeated measures model||Treatment difference uses placebo as the reference.|||-28.30|-41.79|< 0.0001
74061651|NCT02392559|147674952|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
74061652|NCT02392559|147674953|SUPERIORITY||treatment difference|-32.47|STANDARD_ERROR_OF_MEAN|3.21|<|0.0001|TWO_SIDED|95.0|-38.82|-26.13|||repeated measures model||Treatment difference uses placebo as the reference.|||-26.13|-38.82|< 0.0001
74061653|NCT02392559|147674953|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
74061654|NCT02392559|147674954|SUPERIORITY||treatment difference|-30.3|STANDARD_ERROR_OF_MEAN|3.09|<|0.0001|TWO_SIDED|95.0|-36.4|-24.21|||repeated measures model||Treatment difference uses placebo as the reference.|||-24.21|-36.40|< 0.0001
73882319|NCT03585660|147298565|SUPERIORITY|||||||0.08|||||||bootstrap z-test|The standard error of the difference of AUCs was estimated using nonparametric bootstrap, with B=9999 resamples.||The null hypothesis is that the AUCs of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the AUC of HM-MRI is greater than the AUC of mp-MRI.||||0.08
73882320|NCT03585660|147298566|SUPERIORITY|||||||0.97|||||||bootstrap z-test|||The null hypothesis is that the sensitivity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the sensitivity of HM-MRI is greater than the sensitivity of mp-MRI.||||0.97
73882321|NCT03585660|147298567|SUPERIORITY||||||<|0.01|||||||bootstrap z-test|||The null hypothesis is that the specificity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the specificity of HM-MRI is greater than the specificity of mp-MRI.||||<0.01
73882322|NCT03585660|147298568|SUPERIORITY|The null hypothesis is that the PPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the PPV of HM-MRI is greater than the PPV of mp-MRI.||||||0.06|||||||bootstrap z-test|||||||0.06
73882323|NCT03585660|147298569|SUPERIORITY|The null hypothesis is that the NPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the NPV of HM-MRI is greater than the NPV of mp-MRI.||||||0.97|||||||bootstrap z-test|||||||0.97
73888239|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.2475|TWO_SIDED|95.0|-0.54|0.14|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.14|-0.54|0.2475
74061655|NCT02392559|147674954|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
74061656|NCT02392559|147674955|SUPERIORITY||treatment difference|-36.38|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|95.0|-42.97|-29.8|||repeated measures model||Treatment difference uses placebo as the reference.|||-29.80|-42.97|< 0.0001
74061657|NCT02392559|147674955|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
73882324|NCT00435409|147298570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2239||||0.9409|TWO_SIDED|95.0|0.9487|1.5789||Stratification factors included metastatic organ sites (2 or less versus \[vs\] more than \[\>\] 2 sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs \>1), from interactive voice response system (IVRS).|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors||1.5789|0.9487|0.9409
73882325|NCT00435409|147298570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1084||||0.812|TWO_SIDED|95.0|0.8817|1.3935||Stratification factors include metastatic organ sites (2 or less versus \[vs\] 2 or more sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs more than 1), from IVRS.|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors||1.3935|0.8817|0.8120
73882326|NCT00435409|147298571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.3143|TWO_SIDED|95.0|0.69|1.97||A stratified CMH test stratified by randomization stratification factors was used to compare objective response rate (ORR) between two treatment arms.|Cochran-Mantel-Haenszel|||Independent radiology assessment||1.97|0.69|0.3143
73882327|NCT00435409|147298571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.1269|TWO_SIDED|95.0|0.83|2.13||A stratified CMH test stratified by randomization stratification factors was used to compare ORR between two treatment arms.|Cochran-Mantel-Haenszel|||Investigator's assessment||2.13|0.83|0.1269
73882328|NCT00435409|147298573|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0372||||0.6275|TWO_SIDED|95.0|0.8322|1.2927||Stratification factors (all from IVRS) included number of metastatic organ sites (\<=2 vs \>2 sites), hormone receptor status (HER2-/ER-/PR- vs all others), and prior chemotherapy regimens (1 vs \>1).|Log Rank||Hazard ratio for sunitinib + capecitabine versus capecitabine.|||1.2927|0.8322|0.6275
73882329|NCT05635461|147298579|OTHER||Geometric Mean Ratio|60.13|||||TWO_SIDED|90.0|56.12|64.42|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||64.42|56.12|
73882330|NCT05635461|147298580|OTHER||Geometric Mean Ratio|60.12|||||TWO_SIDED|90.0|56.12|64.42|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||64.42|56.12|
73882331|NCT05635461|147298581|OTHER||Geometric Mean Ratio|27.94|||||TWO_SIDED|90.0|25.09|31.13|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||31.13|25.09|
73882332|NCT05635461|147298582|OTHER||Median Difference (Final Values)|1.04|||<|0.0001|TWO_SIDED|90.0|0.9265|2.247|||ANOVA|||||2.2470|0.9265|<0.0001
73882333|NCT05635461|147298582|OTHER||Median Difference (Final Values)|2.78|||<|0.0001|TWO_SIDED|90.0|2.4475|3.0035|||ANOVA|||||3.0035|2.4475|<0.0001
73882334|NCT05635461|147298583|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0||||||||0.000|0.000|
73882335|NCT05635461|147298583|OTHER||Median Difference (Final Values)|0.25||||0.001|TWO_SIDED|90.0|0.0|0.251|||ANOVA|||||0.2510|0.0000|0.0010
73882336|NCT05635461|147298584|OTHER||Geometric Mean Ratio|161.57|||||TWO_SIDED|90.0|150.96|172.92|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||172.92|150.96|
73882337|NCT05635461|147298585|OTHER||Geometric Mean Ratio|161.59|||||TWO_SIDED|90.0|150.98|172.95|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||172.95|150.98|
73882338|NCT05635461|147298586|OTHER||Geometric Mean Ratio|304.19|||||TWO_SIDED|90.0|273.51|338.31|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||338.31|273.51|
73882339|NCT05635461|147298587|OTHER||Median Difference (Final Values)|0.99||||0.0662|TWO_SIDED|90.0|0.006|1.537|||ANOVA|||||1.5370|0.0060|0.0662
73882340|NCT05635461|147298588|OTHER||Median Difference (Final Values)|0.25||||0.0039|TWO_SIDED|90.0|0.0|0.251|||ANOVA|||||0.2510|0.0000|0.0039
73882341|NCT03137654|147298706|SUPERIORITY|||||||0.0078|||||||Linear Mixed Model|||||||.0078
73882342|NCT03137654|147298710|SUPERIORITY|||||||0.393|||||||ANOVA|||||||0.393
73882343|NCT03137654|147298712|SUPERIORITY|||||||0.0344|||||||ANOVA|||||||.0344
73882344|NCT03137654|147298713|SUPERIORITY|||||||0.0344|||||||ANOVA|||||||.0344
73882345|NCT03137654|147298714|SUPERIORITY|||||||0.0365|||||||ANOVA|||||||0.0365
73882346|NCT03137654|147298715|SUPERIORITY|||||||0.212|||||||ANOVA|||||||.212
73882347|NCT03137654|147298716|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
73882348|NCT03137654|147298717|SUPERIORITY|||||||0.445|||||||ANOVA|||||||.445
73882349|NCT03137654|147298718|SUPERIORITY|||||||0.245|||||||ANOVA|||||||.245
73882350|NCT04890652|147298719|OTHER|single group. The power-related information was estimated by calculating the effect size, specifically partial eta squared.|||||<|0.001|||||||General Linear Model|||||||<0.001
73882351|NCT04890652|147298720|OTHER|Single group. The power-related information was estimated by calculating the effect size, specifically partial eta squared.|||||<|0.001|||||||General Linear Model|||||||<0.001
73882352|NCT02646826|147298723|SUPERIORITY|||||||0.0017|||||||ANOVA|||||||0.0017
73882353|NCT02646826|147298724|SUPERIORITY||||||<|0.44|||||||ANOVA|||||||<.44
74061658|NCT03078192|147674988|OTHER|Detecting pre-capillary PH was tested with a cohort of 32 patients. True PH status was based on RHC. A diagnosis of PH was established from mPAP \>20mmHg, while pre-capillary PH required PCWP ≤ 15mmHg and PVR ≥ 3 Woods Units, and post capillary PH required PCWP \> 15mmH and PVR \< 3 Woods Units \[21\]. Patients with both high PVR and PCWP \> 15mmHg were classified as combined pre- and post-capillary PH (CpcPH). Subjects with CpcPH were treated as positive for both pre- and post-capillary PH.|positive predictive value|0.86|||||TWO_SIDED|||||Positive predictive value for Precapillary Pulmonary Hypertension: 86%|calculation of PPV|||||||
74061659|NCT02508649|147674992|SUPERIORITY||Treatment difference|0.55||||0.3015|TWO_SIDED|95.0|-1.34|2.43|||van Elteren test|||The primary endpoint was analyzed using a van Elteren test. The analysis included a test of superiority using a two-sided 5% significance level.||2.43|-1.34|0.3015
74061660|NCT02508649|147674993|SUPERIORITY||Odds Ratio (OR)|1.049||||0.7694|TWO_SIDED|95.0|0.762|1.445|||Regression, Logistic||An odds ratio \< 1 in proportion of subjects dying indicates lower mortality in the selepressin group.|Mortality was analyzed using a logistic regression model with the individual sequential organ failure assessment (SOFA) scores and age as covariates and treatment arm as factor.||1.445|0.762|0.7694
74061661|NCT02508649|147674994|SUPERIORITY||Treatment difference|0.29||||0.8458|TWO_SIDED|95.0|-2.07|2.65|||van Elteren test|||This endpoint was analyzed using a van Elteren test. The analysis was a test of superiority using a two-sided 5% significance level.||2.65|-2.07|0.8458
74061662|NCT02508649|147674995|SUPERIORITY||Treatment difference|0.49||||0.4124|TWO_SIDED|95.0|-1.22|2.19|||van Elteren test|||This endpoint was analyzed using a van Elteren test. The analysis was a test of superiority using a two-sided 5% significance level.||2.19|-1.22|0.4124
74061663|NCT02508649|147675002|OTHER||Treatment difference|-0.51||||0.2009|TWO_SIDED|95.0|-1.3|0.27|||ANCOVA|||Overall score using a modified version of the SOFA on Day 1||0.27|-1.30|0.2009
74061664|NCT02508649|147675002|OTHER||Treatment difference|0.11||||0.7894|TWO_SIDED|95.0|-0.68|0.9|||ANCOVA|||Overall score using a modified version of the SOFA on Day 3||0.90|-0.68|0.7894
74061665|NCT02508649|147675002|OTHER||Treatment difference|0.55||||0.1888|TWO_SIDED|95.0|-0.27|1.37|||ANCOVA|||Overall score using a modified version of the SOFA on Day 7||1.37|-0.27|0.1888
74061666|NCT02508649|147675002|OTHER||Treatment difference|-0.08||||0.2997|TWO_SIDED|95.0|-0.24|0.07|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 1||0.07|-0.24|0.2997
74061667|NCT02508649|147675002|OTHER||Treatment difference|-0.03||||0.6796|TWO_SIDED|95.0|-0.19|0.12|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 3||0.12|-0.19|0.6796
74061668|NCT02508649|147675002|OTHER||Treatment difference|0.03||||0.7467|TWO_SIDED|95.0|-0.14|0.19|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 7||0.19|-0.14|0.7467
74061669|NCT02508649|147675002|OTHER||Treatment difference|-0.42||||0.0003|TWO_SIDED|95.0|-0.65|-0.19|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 1||-0.19|-0.65|0.0003
74061670|NCT02508649|147675002|OTHER||Treatment difference|-0.25||||0.0349|TWO_SIDED|95.0|-0.49|-0.02|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 3||-0.02|-0.49|0.0349
74061671|NCT02508649|147675002|OTHER||Treatment difference|-0.14||||0.2787|TWO_SIDED|95.0|-0.39|0.11|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 7||0.11|-0.39|0.2787
74061672|NCT02508649|147675002|OTHER||Treatment difference|-0.05||||0.6476|TWO_SIDED|95.0|-0.26|0.16|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 1||0.16|-0.26|0.6476
74061673|NCT02508649|147675002|OTHER||Treatment difference|0.08||||0.4313|TWO_SIDED|95.0|-0.13|0.29|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 3||0.29|-0.13|0.4313
73882354|NCT00614575|147298735|SUPERIORITY_OR_OTHER||Mean change from baseline|-7.2|STANDARD_DEVIATION|9.0|<|0.0001|||||||Paired t-test|||||||<0.0001
73882355|NCT00614575|147298736|SUPERIORITY_OR_OTHER||Mean change from baseline|-4.8|STANDARD_DEVIATION|7.8|<|0.0001|||||||Paired t-test|||||||<0.0001
73882356|NCT00614575|147298737|SUPERIORITY_OR_OTHER||Mean change from baseline|-0.7|STANDARD_DEVIATION|0.9|<|0.0001|||||||paired t-test|||||||<0.0001
73882357|NCT00614575|147298738|SUPERIORITY_OR_OTHER||mean change from baseline|-0.3|STANDARD_DEVIATION|0.6|<|0.0001|||||||paired t-test|||||||<0.0001
73882358|NCT00286442|147298751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.68|-0.32||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Analysis of covariance (ANCOVA) with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 participants had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of participants meeting per protocol criteria.||-0.32|-0.68|<0.001
74061674|NCT02508649|147675002|OTHER||Treatment difference|0.17||||0.1334|TWO_SIDED|95.0|-0.05|0.39|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 7||0.39|-0.05|0.1334
74061675|NCT02508649|147675002|OTHER||Treatment difference|0.12||||0.2126|TWO_SIDED|95.0|-0.07|0.3|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 1||0.30|-0.07|0.2126
74061676|NCT02508649|147675002|OTHER||Treatment Difference|0.23||||0.0174|TWO_SIDED|95.0|0.04|0.41|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 3||0.41|0.04|0.0174
74061677|NCT02508649|147675002|OTHER||Treatment difference|0.23||||0.0194|TWO_SIDED|95.0|0.04|0.43|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 7||0.43|0.04|0.0194
74061678|NCT02508649|147675002|OTHER||Treatment difference|-0.15||||0.1284|TWO_SIDED|95.0|-0.35|0.04|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 1||0.04|-0.35|0.1284
74061679|NCT02508649|147675002|OTHER||Treatment difference|-0.05||||0.6542|TWO_SIDED|95.0|-0.25|0.15|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 3||0.15|-0.25|0.6542
74061680|NCT02508649|147675002|OTHER||Treatment difference|0.17||||0.1079|TWO_SIDED|95.0|-0.04|0.38|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 7||0.38|-0.04|0.1079
74061681|NCT02508649|147675003|OTHER||Odds Ratio (OR)|1.4||||0.063|TWO_SIDED|95.0|0.98|2.0|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ dysfunction up to Day 7||2.00|0.98|0.0630
74061682|NCT02508649|147675003|OTHER||Odds Ratio (OR)|1.28||||0.1875|TWO_SIDED|95.0|0.89|1.86|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ dysfunction up to Day 30||1.86|0.89|0.1875
74061683|NCT02508649|147675003|OTHER||Odds Ratio (OR)|1.14||||0.4382|TWO_SIDED|95.0|0.82|1.58|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ failure up to Day 7||1.58|0.82|0.4382
74061684|NCT02508649|147675003|OTHER||Odds Ratio (OR)|1.01||||0.9529|TWO_SIDED|95.0|0.73|1.39|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ failure up to Day 30||1.39|0.73|0.9529
74061685|NCT00417859|147675024|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||FB group was designated the control group. We determined a sample size based in clinical criteria. Using an α of 0.05 and β of 0.8, the required sample size was calculated to be 24 patients in each group to achieve a power of 80%. Descriptive analysis was completed on demographic information and clinical and radiological outcomes. Nonparametric tests (Wilcoxon's signed ranks or rank sum tests) were used for comparison of scores. The chi-squared test was used for dichotomous variables.||||0.05
73882359|NCT00286442|147298751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.67|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming SD=0.8%, 2-sided test at 0.05 significance level and \>=80% of participants meeting per protocol criteria.||-0.30|-0.67|<0.001
73882360|NCT00286442|147298752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.37|-0.16||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.16|-0.37|<0.001
73882361|NCT00286442|147298752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.19||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.19|-0.40|<0.001
74061686|NCT03594175|147675030|SUPERIORITY||Mean difference of proportions, Wald|29.51||||0.003|TWO_SIDED|95.0|10.76|48.26|||2-sample Z test for proportions|||CUSA-081 vs Placebo Dwell Time Up To 90 Min -- FAS||48.26|10.76|0.003
73888240|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|||<|0.0001|TWO_SIDED|95.0|-1.96|-1.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.27|-1.96|<0.0001
74061687|NCT03594175|147675031|NON_INFERIORITY|Non-inferiority was assessed based on the constructed 95% confidence interval (CI) for the difference in the rate of treatment success between CUSA-081 vs alteplase, with non-inferiority considered as demonstrated if the lower limit of the 95% CI for the difference in rate of success is greater than -10%.|Mean difference of proportions, Wald|-10.31||||0.03|TWO_SIDED|95.0|-19.38|-1.24|||2-sample Z test for proportions|||||-1.24|-19.38|0.030
74061688|NCT03594175|147675032|SUPERIORITY||Mean difference of proportions, Wald|24.13||||0.017|TWO_SIDED|95.0|5.84|42.41|||2-sample Z test for proportions|||||42.41|5.84|0.017
74061689|NCT03594175|147675033|SUPERIORITY||Mean difference of proportions, Wald|41.08|||<|0.001|TWO_SIDED|95.0|21.94|60.21|||2-sample Z test for proportions|||||60.21|21.94|<0.001
74061690|NCT03594175|147675034|SUPERIORITY||Mean difference of proportions, Wald|-10.96||||0.019|TWO_SIDED|95.0|-19.89|-2.04|||2-sample Z test for proportions|||||-2.04|-19.89|0.019
74061691|NCT03594175|147675035|SUPERIORITY||Probability Re-Occlusion Free at Day 30|0.948|||||TWO_SIDED|95.0|0.126|7.121||||||Time to first re-occlusion.||7.121|0.126|
74061692|NCT03594175|147675035|OTHER||Cox Proportional Hazard|0.654|||||TWO_SIDED|95.0|0.337|1.27||||||Time to first re-occlusion.||1.270|0.337|
74061693|NCT03594175|147675035|OTHER||Cox Proportional Hazard|1.448|||||TWO_SIDED|95.0|0.193|10.848||||||Time to first re-occlusion.||10.848|0.193|
74061694|NCT00633217|147675158|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% confidence interval for the mean difference in 2-hour post-dose FEV1 change from baseline fell above -75 mL, then HFA MDI could be deemed non-inferior to DISKUS treatment response.||||||0.021||95.0|||||ANCOVA|||||||0.021
74061695|NCT00689273|147675170|SUPERIORITY||Least Square (LS) Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.57||0.39|TWO_SIDED|80.0|-1.23|0.24|||Mixed Models Analysis|||Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect. One-sided alpha of 0.1 was used for the analysis.||0.24|-1.23|0.39
74061696|NCT00689273|147675171|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.52||0.63|TWO_SIDED|80.0|-0.92|0.42|||Mixed Models Analysis|||Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.42|-0.92|0.63
74061697|NCT00689273|147675172|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.27||0.54|TWO_SIDED|80.0|-0.51|0.18|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.18|-0.51|0.54
74061698|NCT00689273|147675172|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|80.0|-0.51|0.21|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.21|-0.51|0.60
74061699|NCT00689273|147675173|SUPERIORITY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|1.8||0.44|TWO_SIDED|80.0|-3.69|0.94|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.94|-3.69|0.44
74061700|NCT00689273|147675173|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|2.0||0.23|TWO_SIDED|80.0|-5.0|0.16|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.16|-5.00|0.23
74061701|NCT00689273|147675174|SUPERIORITY||LS Mean Difference|-1.76|STANDARD_ERROR_OF_MEAN|2.46||0.48|TWO_SIDED|80.0|-4.94|1.41|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||1.41|-4.94|0.48
74061702|NCT00689273|147675174|SUPERIORITY||LS Mean Difference|-3.02|STANDARD_ERROR_OF_MEAN|2.79||0.28|TWO_SIDED|80.0|-6.61|0.57|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.57|-6.61|0.28
74061703|NCT00689273|147675175|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.91||0.48|TWO_SIDED|80.0|-1.81|0.52|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.52|-1.81|0.48
74061704|NCT00689273|147675175|SUPERIORITY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|1.03||0.28|TWO_SIDED|80.0|-2.45|0.2|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.20|-2.45|0.28
74061705|NCT00689273|147675176|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.19||0.28|TWO_SIDED|80.0|-0.46|0.04|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.04|-0.46|0.28
74061706|NCT00689273|147675176|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.28||0.14|TWO_SIDED|80.0|-0.78|-0.06|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.06|-0.78|0.14
74061707|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.28||0.55|TWO_SIDED|80.0|-0.52|0.19|||Mixed Models Analysis|||Day 1: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.19|-0.52|0.55
74061708|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.28||0.11|TWO_SIDED|80.0|-0.81|-0.09|||Mixed Models Analysis|||Day 2: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.09|-0.81|0.11
74061709|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.28||0.2|TWO_SIDED|80.0|-0.71|0.0|||Mixed Models Analysis|||Day 3: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.00|-0.71|0.20
74061710|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.23|TWO_SIDED|80.0|-0.69|0.02|||Mixed Models Analysis|||Day 4: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.02|-0.69|0.23
73888241|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.62|||<|0.0001|TWO_SIDED|95.0|-2.96|-2.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.27|-2.96|<0.0001
73882362|NCT00286442|147298753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001|TWO_SIDED|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.52|<0.001
73888242|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.68|-1.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.00|-1.68|<0.0001
73882363|NCT00286442|147298753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001|TWO_SIDED|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.52|<0.001
74061711|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_DEVIATION|0.28||0.41|TWO_SIDED|80.0|-0.58|0.13|||Mixed Models Analysis|||Day 5: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.13|-0.58|0.41
74061712|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.62|TWO_SIDED|80.0|-0.49|0.22|||Mixed Models Analysis|||Day 6: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.22|-0.49|0.62
73882364|NCT00286442|147298754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.66|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.66|<0.001
74061713|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.28||0.49|TWO_SIDED|80.0|-0.55|0.16|||Mixed Models Analysis|||Day 7: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.16|-0.55|0.49
74061714|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_DEVIATION|0.28||0.1|TWO_SIDED|80.0|-0.81|-0.1|||Mixed Models Analysis|||Day 8: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.10|-0.81|0.10
74061715|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.24|TWO_SIDED|80.0|-0.69|0.03|||Mixed Models Analysis|||Day 9: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.03|-0.69|0.24
74061716|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.02|TWO_SIDED|80.0|-1.01|-0.28|||Mixed Models Analysis|||Day 10: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.28|-1.01|0.02
74061717|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.28||0.04|TWO_SIDED|80.0|-0.93|-0.21|||Mixed Models Analysis|||Day 11: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.21|-0.93|0.04
74061718|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.28||0.04|TWO_SIDED|80.0|-0.95|-0.23|||Mixed Models Analysis|||Day 12: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.23|-0.95|0.04
74061719|NCT00689273|147675177|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.24|TWO_SIDED|80.0|-0.7|0.03|||Mixed Models Analysis|||Day 13: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.03|-0.70|0.24
74061720|NCT00689273|147675177|SUPERIORITY||Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.28||0.11|TWO_SIDED|80.0|-0.82|-0.09|||Mixed Models Analysis|||Day 14: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.09|-0.82|0.11
74061721|NCT00689273|147675178|SUPERIORITY|||||||0.22|||||||Cochran-Mantel-Haenszel|||30% Reduction||||0.22
74061722|NCT00689273|147675178|SUPERIORITY|||||||0.38|||||||Cochran-Mantel-Haenszel|||50% Reduction||||0.38
74061723|NCT00689273|147675179|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.45|TWO_SIDED|80.0|-0.27|0.07|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.07|-0.27|0.45
74061724|NCT00689273|147675179|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.37|TWO_SIDED|80.0|-0.29|0.05|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.05|-0.29|0.37
74061725|NCT01238172|147675196|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.76|TWO_SIDED|95.0|0.75|1.24|||Log Rank|||||1.24|0.75|0.76
74061726|NCT01238172|147675197|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.71|TWO_SIDED|95.0|0.23|8.41|||Log Rank|||||8.41|0.23|0.71
74061727|NCT01238172|147675198|SUPERIORITY|||||||0.995|||||||Wilcoxon (Mann-Whitney)|||||||0.995
74061728|NCT01238172|147675199|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Two-sided||||||<0.001
74061729|NCT02395536|147675266|NON_INFERIORITY|A non-inferiority margin of 5% was chosen since the inability to rule out a 5% increase in untoward event rate associated with moving the Reveal LINQ procedure in-office may suggest that in-office procedures would too high of a complication rate compared procedures performed in the traditional office setting.|Risk Difference (RD)|-0.001|||<|0.001|TWO_SIDED|95.0|-0.03|0.029||P-value for non-inferiority versus a 5% non-inferiority margin.|Farrington-Manning test||The estimated value and its associated confidence interval are for the in-office minus traditional hospital setting difference in the untoward event rates. The point estimate is negative since the in-office rate was lower than the hospital rate.|The null hypothesis was that Reveal LINQ insertions performed in-office would have a higher untoward event rate than insertions performed in the traditional hospital setting. A sample size of 476 subjects was estimated to provide at least 90% power at a 1-sided alpha level of 2.5% and 5% non-inferiority margin. For the sample size calculation, an event rate of 2.0% was assumed in both arms. The Farrington-Manning test of two indepent proportions was used to compare study arms.||0.029|-0.030|<0.001
74061730|NCT01186744|147675274|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Log Rank|||||||0.0008
74061731|NCT01186744|147675274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
74061732|NCT01186744|147675275|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED||||||Log Rank|||||||0.0027
74061733|NCT01186744|147675275|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
74061734|NCT02547779|147675399|SUPERIORITY||Odds Ratio (OR)|0.95|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
74061735|NCT02547779|147675400|SUPERIORITY||Odds Ratio (OR)|0.98|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
74061736|NCT01020773|147675401|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
74061737|NCT01389024|147675402|SUPERIORITY||Incidence rate ratio|0.216||||0.2914|TWO_SIDED|90.0|0.009|1.66|||Poisson Regression||We calculated confidence intervals from exact Poisson regression.|||1.66|.009|0.2914
74061738|NCT00545441|147675413|NON_INFERIORITY_OR_EQUIVALENCE|Alpha = 0.05 and power = 0.8, a non-inferiority margin of 10%.||||||0.59|TWO_SIDED||||||Fisher Exact|||||||0.59
74061739|NCT04071366|147675423|SUPERIORITY||Difference in CRS rate|-0.39||||0.003|TWO_SIDED|95.0|-0.6463|-0.1363|||One-sided Z-test|||||-0.1363|-0.6463|0.0030
74061740|NCT04071366|147675423|OTHER||Difference in CRS rate|-0.37|||||TWO_SIDED|95.0|-0.6073|-0.1231||||||||-0.1231|-0.6073|
74061741|NCT04071366|147675423|OTHER||Difference in CRS rate|0.03|||||TWO_SIDED|95.0|-0.1778|0.2299||||||||0.2299|-0.1778|
74061742|NCT00858234|147675439|OTHER|Accumulation Ratio (Day 11 AUC0-24hr/Day 1 AUC0-24hr)|Accumulation ratio|1.08|||||TWO_SIDED|90.0|0.8|1.45|||||Back-transformed least squares mean difference and 90% confidence interval from mixed effects model performed on natural log-transformed values.|||1.45|0.80|
74061743|NCT00529802|147675467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.69|TWO_SIDED|95.0|-9.3|13.23|||t-test, 2 sided|Relative changes in tumor size were log-transformed to satisfy the normality assumption for the t-test.|Mean difference is the difference between Low and High SUV uptake groups in tumor size percent (%) change from baseline, and is reported on the raw scale. Tumor size changes were log-transformed for the t-test.|Relative changes in tumor size were log-transformed to satisfy the normality assumption.||13.23|-9.3|0.69
74061744|NCT00529802|147675468|SUPERIORITY_OR_OTHER||Slope|0.0028|STANDARD_ERROR_OF_MEAN|0.00109||0.013|TWO_SIDED|95.0|0.00063|0.004997|||Regression, Linear|Tumor size change (outcome variable) was log-transformed to satisfy the normality assumption.|Outcome was log(tumor size at 8 weeks/tumor size at baseline), and the predictor was the early change in aveSUVmax \[(aveSUVmax at 2 weeks - aveSUVmax at baseline)/aveSUVmax at baseline\] x 100%.|The relationship between early changes in SUV uptake (from baseline to 2 weeks) and tumor size changes (from baseline to 8 weeks) were examined using linear regression models. Tumor size change was log-transformed to satisfy the normality assumption.||0.004997|0.00063|0.013
74061745|NCT02675426|147675469|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.1|||<|0.001|TWO_SIDED|95.0|19.1|37.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||37.0|19.1|<0.001
73882365|NCT00286442|147298754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.66|-0.34||No multiplicity adjustments|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.66|<0.001
73882366|NCT00286442|147298755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.7|-0.36||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.70|<0.001
74061746|NCT02675426|147675469|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.5|||<|0.001|TWO_SIDED|95.0|21.6|39.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.4|21.6|<0.001
74061747|NCT02675426|147675470|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|23.0|39.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.5|23.0|<0.001
74061748|NCT02675426|147675470|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.8|||<|0.001|TWO_SIDED|95.0|22.5|39.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.0|22.5|<0.001
74061749|NCT02675426|147675471|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Least Squares (LS) Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.42|-0.94||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.94|-1.42|<0.001
74061750|NCT02675426|147675471|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.32|||<|0.001|TWO_SIDED|95.0|-1.56|-1.08||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.08|-1.56|<0.001
74061751|NCT02675426|147675472|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.43|-0.24||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.24|-0.43|<0.001
74061752|NCT02675426|147675472|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.38|-0.18||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.18|-0.38|<0.001
74061753|NCT02675426|147675473|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.55|||<|0.001|TWO_SIDED|95.0|3.13|5.98||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.98|3.13|<0.001
74061754|NCT02675426|147675473|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.98|||<|0.001|TWO_SIDED|95.0|3.54|6.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.42|3.54|<0.001
73882367|NCT00286442|147298755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
73882368|NCT00286442|147298756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
73882369|NCT00286442|147298756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
73882370|NCT00286442|147298757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.001|TWO_SIDED|95.0|-20.7|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.|||-6.8|-20.7|<0.001
74061755|NCT02675426|147675474|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|20.8|||<|0.001|TWO_SIDED|95.0|13.6|28.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||28.1|13.6|<0.001
74061756|NCT02675426|147675474|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|18.4|||<|0.001|TWO_SIDED|95.0|11.2|25.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||25.5|11.2|<0.001
74061757|NCT02675426|147675475|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|21.3|||<|0.001|TWO_SIDED|95.0|13.0|29.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||29.5|13.0|<0.001
74061758|NCT02675426|147675475|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|23.0|||<|0.001|TWO_SIDED|95.0|14.7|31.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||31.3|14.7|<0.001
74061759|NCT02675426|147675476|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-51.01|||<|0.001|TWO_SIDED|95.0|-78.14|-23.87||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.87|-78.14|<0.001
74061760|NCT02675426|147675476|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-50.86|||<|0.001|TWO_SIDED|95.0|-78.19|-23.53||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.53|-78.19|<0.001
74061761|NCT02675426|147675477|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.95|||<|0.001|TWO_SIDED|95.0|3.31|6.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.60|3.31|<0.001
74061762|NCT02675426|147675477|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.78|||<|0.001|TWO_SIDED|95.0|3.12|6.44||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.44|3.12|<0.001
74061763|NCT02675426|147675478|SUPERIORITY||Response Rate Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.0||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||31.0|15.1|<0.001
74061764|NCT02675426|147675478|SUPERIORITY||Response Rate Difference|28.4|||<|0.001|TWO_SIDED|95.0|20.4|36.5||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||36.5|20.4|<0.001
74061765|NCT02675426|147675479|SUPERIORITY||Response Rate Difference|14.9|||<|0.001|TWO_SIDED|95.0|8.7|21.1||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||21.1|8.7|<0.001
74061766|NCT02675426|147675479|SUPERIORITY||Response Rate Difference|20.6|||<|0.001|TWO_SIDED|95.0|14.0|27.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||27.2|14.0|<0.001
74061767|NCT02675426|147675480|SUPERIORITY||Response Rate Difference|13.6|||<|0.001|TWO_SIDED|95.0|7.0|20.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||20.2|7.0|<0.001
74061768|NCT02675426|147675480|SUPERIORITY||Response Rate Difference|19.7|||<|0.001|TWO_SIDED|95.0|12.7|26.7||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use|Response Rate Difference = Upadacitinib - Placebo|||26.7|12.7|<0.001
74061769|NCT00080288|147675525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.0001||95.0|1.67|3.69|||ANCOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||3.69|1.67|<0.0001
74061770|NCT00080288|147675526|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|The p value for each treatment group is for the comparison of that treatment group to the placebo treatment group. Adjusted for country.||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||||0.0010
74061771|NCT02953262|147675532|SUPERIORITY|||||||0.057||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.057
74061772|NCT02953262|147675532|SUPERIORITY|||||||0.753||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.753
74061773|NCT02953262|147675532|SUPERIORITY|||||||0.613||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.613
74061774|NCT02953262|147675533|SUPERIORITY|||||||0.308||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.308
74061775|NCT02953262|147675533|SUPERIORITY|||||||0.154||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.154
74061776|NCT02953262|147675533|SUPERIORITY|||||||0.025||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.025
74061777|NCT02953262|147675534|SUPERIORITY|||||||0.102||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.102
74061778|NCT02953262|147675534|SUPERIORITY|||||||0.023||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.023
74061779|NCT02953262|147675534|SUPERIORITY|||||||0.439||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.439
74061780|NCT02953262|147675535|SUPERIORITY|||||||0.982||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.982
74061781|NCT02953262|147675535|SUPERIORITY|||||||0.559||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.559
74061782|NCT02953262|147675535|SUPERIORITY|||||||0.032||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.032
74061783|NCT04604496|147675580|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|133.17|||||TWO_SIDED|90.0|81.97|216.37||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||216.37|81.97|
74061784|NCT04604496|147675580|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|219.98|||||TWO_SIDED|90.0|135.39|357.41||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||357.41|135.39|
74061785|NCT04604496|147675580|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|334.21|||||TWO_SIDED|90.0|205.7|543.0||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||543.00|205.70|
73882371|NCT00286442|147298757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.9|||<|0.001|TWO_SIDED|95.0|-18.9|-4.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.|||-4.9|-18.9|<0.001
74061786|NCT04604496|147675581|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|122.7|||||TWO_SIDED|90.0|61.33|245.49||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||245.49|61.33|
74061787|NCT04604496|147675581|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|282.73|||||TWO_SIDED|90.0|141.32|565.66||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||565.66|141.32|
74061788|NCT04604496|147675581|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|640.78|||||TWO_SIDED|90.0|320.27|1282.0||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||1282.00|320.27|
74061789|NCT04604496|147675582|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|122.89|||||TWO_SIDED|90.0|61.51|245.51||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||245.51|61.51|
74061790|NCT04604496|147675582|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|283.88|||||TWO_SIDED|90.0|142.1|567.13||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||567.13|142.10|
74061791|NCT04604496|147675582|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|636.32|||||TWO_SIDED|90.0|318.51|1271.24||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||1271.24|318.51|
74061792|NCT04604496|147675583|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|85.19|||||TWO_SIDED|90.0|63.6|114.1||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||114.10|63.60|
74061793|NCT04604496|147675583|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|96.37|||||TWO_SIDED|90.0|71.95|129.07||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||129.07|71.95|
74061794|NCT04604496|147675583|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|135.2|||||TWO_SIDED|90.0|100.94|181.1||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||181.10|100.94|
74061795|NCT00110084|147675667|SUPERIORITY_OR_OTHER||Proportion of confirmed responses (%)|50.0|||||TWO_SIDED|95.0|36.0|64.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.||64|36|
74061796|NCT00703261|147675680|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||cLDA|||Constrained longitudinal data analysis (cLDA)||||0.006
74061797|NCT00703261|147675680|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||cLDA|||||||0.277
74061798|NCT00703261|147675680|SUPERIORITY_OR_OTHER||Percent Reduction|4.5||||0.088|TWO_SIDED|90.0|-1.0|9.6|||cLDA|||||9.6|-1.0|0.088
74061799|NCT00703261|147675681|SUPERIORITY_OR_OTHER|||||||0.195||95.0|||||cLDA|||||||0.195
74061800|NCT02115373|147675695|OTHER||Median|2.07|||||TWO_SIDED|90.0|1.446|7.195|||||TTP in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||7.195|1.446|
74061801|NCT02115373|147675695|OTHER||Median|3.98|||||TWO_SIDED|90.0|2.858|4.238|||||TTP in months was calculated for Phase 2: Tepotinib 500 mg.|||4.238|2.858|
74061802|NCT02115373|147675696|OTHER||Median|1.51|||||TWO_SIDED|90.0|1.413|3.68|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||3.680|1.413|
74061803|NCT02115373|147675696|OTHER||Median|3.22|||||TWO_SIDED|90.0|0.03|16.53|||||PFS time in months was calculated for Phase 2: Tepotinib 500 mg.|||16.53|0.03|
74061804|NCT02115373|147675697|OTHER||Median|1.48|||||TWO_SIDED|90.0|1.413|3.844|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||3.844|1.413|
74061805|NCT02115373|147675697|OTHER||Median|3.35|||||TWO_SIDED|90.0|2.76|4.172|||||PFS time in months was was calculated for Phase 2: Tepotinib 500 mg.|||4.172|2.760|
74061806|NCT02115373|147675699|OTHER||Median|7.2|||||TWO_SIDED|90.0|3.68|10.119|||||Overall Survival time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||10.119|3.680|
74061807|NCT02115373|147675699|OTHER||Median|5.55|||||TWO_SIDED|90.0|5.092|8.181|||||Overall Survival time in months was calculated for Phase 2: Tepotinib 500 mg.|||8.181|5.092|
74061808|NCT03747939|147675734|SUPERIORITY||Adjusted difference in proportions|18.5||||0.0008|TWO_SIDED|95.0|8.9|28.1|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per Interactive Web Response System (IWRS) data, using Cochran-Mantel-Haenszel (CMH) weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||28.1|8.9|0.0008
73888243|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.42|||<|0.0001|TWO_SIDED|95.0|-2.76|-2.08|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.08|-2.76|<0.0001
74061809|NCT03747939|147675735|SUPERIORITY||Adjusted difference in proportions|18.6||||0.0017|TWO_SIDED|95.0|7.0|30.2|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||30.2|7.0|0.0017
74061810|NCT03747939|147675736|SUPERIORITY||Adjusted difference in proportions|5.1||||0.3539|TWO_SIDED|95.0|-5.8|16.0|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||16.0|-5.8|0.3539
74061811|NCT03747939|147675737|SUPERIORITY||Adjusted difference in proportions|22.1||||0.0003|TWO_SIDED|95.0|10.4|33.7|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||33.7|10.4|0.0003
73882372|NCT00286442|147298758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-23.9|-9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.5|-23.9|<0.001
73882373|NCT00286442|147298758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.001|TWO_SIDED|95.0|-24.1|-9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.6|-24.1|<0.001
73882374|NCT00286442|147298759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||<|0.001|TWO_SIDED|95.0|-24.6|-11.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-11.0|-24.6|<0.001
73882375|NCT00286442|147298759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|||<|0.001|TWO_SIDED|95.0|-24.3|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.6|-24.3|<0.001
73882376|NCT00286442|147298760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|||<|0.001|TWO_SIDED|95.0|-28.0|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-28.0|<0.001
74061812|NCT03747939|147675738|SUPERIORITY||Adjusted difference in proportions|11.8||||0.0286|TWO_SIDED|95.0|1.7|22.0|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||22.0|1.7|0.0286
74061813|NCT03747939|147675739|SUPERIORITY||Adjusted difference in proportions|16.3||||0.0022|TWO_SIDED|95.0|6.9|25.8|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||25.8|6.9|0.0022
74061814|NCT03747939|147675740|SUPERIORITY||Difference in LS means|-1.03|||<|0.0001|TWO_SIDED|95.0|-1.48|-0.59|||MMRM||Apremilast - Placebo|Difference in LS means is based MMRM of the change from baseline.||-0.59|-1.48|<0.0001
74061815|NCT03747939|147675741|SUPERIORITY||Adjusted difference in proportions|17.7||||0.0043|TWO_SIDED|95.0|5.7|29.7|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||29.7|5.7|0.0043
74061816|NCT01215955|147675742|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|||||TWO_SIDED|95.0|-0.15|0.22|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||0.22|-0.15|
73882377|NCT00286442|147298760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|95.0|-25.6|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.7|-25.6|<0.001
73882378|NCT00286442|147298761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||<|0.001|TWO_SIDED|95.0|-25.6|-8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.9|-25.6|<0.001
74061817|NCT01215955|147675742|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|||||TWO_SIDED|95.0|-0.12|0.24|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||0.24|-0.12|
74061818|NCT01215955|147675743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.128|TWO_SIDED|95.0|0.52|1.09||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.09|0.520|0.128
73882379|NCT00286442|147298761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-25.4|-8.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.6|-25.4|<0.001
73882380|NCT00286442|147298762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.001|TWO_SIDED|95.0|-27.4|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.8|-27.4|<0.001
73882381|NCT00286442|147298762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-25.0|-8.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.3|-25.0|<0.001
74061819|NCT01215955|147675743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.625|TWO_SIDED|95.0|0.58|1.39||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.39|0.580|0.625
74061820|NCT01215955|147675743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.162|TWO_SIDED|95.0|0.53|1.11||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.11|0.53|0.162
74061821|NCT01215955|147675743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.723|TWO_SIDED|95.0|0.61|1.4||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Linear|||||1.40|0.61|0.723
74061822|NCT01215955|147675744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.701|TWO_SIDED|95.0|0.52|2.67||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||2.67|0.520|0.701
74061823|NCT01215955|147675744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.249|TWO_SIDED|95.0|0.71|3.7||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||3.70|0.710|0.249
74061824|NCT01215955|147675744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.015|TWO_SIDED|95.0|0.13|0.8||P-value is for HbA1c ≤7% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|Included treatment and effects for baseline stratification variables: Baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use.||||0.80|0.13|0.015
74061825|NCT01215955|147675744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.078|TWO_SIDED|95.0|0.17|1.1||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.10|0.17|0.078
74061826|NCT01215955|147675745|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81||||0.014|TWO_SIDED|95.0|0.17|1.46||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||1.46|0.17|0.014
74061827|NCT01215955|147675745|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.5||||0.108|TWO_SIDED|95.0|-1.12|0.11||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.11|-1.12|0.108
74061828|NCT01215955|147675746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.182|TWO_SIDED|95.0|0.57|1.11||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.||||1.11|0.57|0.182
74061829|NCT01215955|147675746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.46|TWO_SIDED|95.0|0.65|1.22||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.||||1.22|0.65|0.460
74061830|NCT01215955|147675747|SUPERIORITY_OR_OTHER||LS Mean Differences|0.29|||||TWO_SIDED|95.0|-0.19|0.77|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|||0.77|-0.19|
74061831|NCT01215955|147675747|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81|||||TWO_SIDED|95.0|0.3|1.31|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|||1.31|0.30|
74061832|NCT01215955|147675748|SUPERIORITY_OR_OTHER||LS Mean Differences|0.59||||0.242|TWO_SIDED|95.0|-0.4|1.58||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||1.58|-0.40|0.242
74061833|NCT01215955|147675748|SUPERIORITY_OR_OTHER||LS Mean Differences|1.13||||0.082|TWO_SIDED|95.0|-0.15|2.41||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without 24-week values were handled by the statistical model.|||2.41|-0.15|0.082
73888244|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.91|||<|0.0001|TWO_SIDED|95.0|-13.21|-10.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-10.60|-13.21|<0.0001
74061834|NCT01215955|147675749|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.15||||0.723|TWO_SIDED|95.0|-0.95|0.66||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model|||0.66|-0.95|0.723
74061835|NCT01215955|147675749|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.28||||0.495|TWO_SIDED|95.0|-1.08|0.52||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model|||0.52|-1.08|0.495
74061836|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|3.32||||0.245|TWO_SIDED|95.0|-2.28|8.93||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||8.93|-2.28|0.245
74061837|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71||||0.842|TWO_SIDED|95.0|-7.71|6.29||P-value is for Morning 2-HR PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||6.29|-7.71|0.842
74061838|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42||||0.626||95.0|-4.32|7.16||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||7.16|-4.32|0.626
74061839|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.48||||0.358|TWO_SIDED|95.0|-10.91|3.95||P-value is for Midday 2-Hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||3.95|-10.91|0.358
74061840|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|3.38||||0.322|TWO_SIDED|95.0|-3.32|10.07||P-value is for Evening Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||10.07|-3.32|0.322
74061841|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.25||||0.617|TWO_SIDED|95.0|-11.08|6.58||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||6.58|-11.08|0.617
74061842|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|2.37||||0.519|TWO_SIDED|95.0|-4.86|9.6||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||9.60|-4.86|0.519
74061843|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.415|TWO_SIDED|95.0|-2.96|7.15||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||7.15|-2.96|0.415
74061844|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|4.38||||0.198|TWO_SIDED|95.0|-2.3|11.06||P-value is for Morning 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||11.06|-2.30|0.198
74061845|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|6.22||||0.045|TWO_SIDED|95.0|0.14|12.29||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||12.29|0.14|0.045
74061846|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|3.07||||0.426|TWO_SIDED|95.0|-4.5|10.64||P-value is for Midday 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||10.64|-4.50|0.426
74061847|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|5.66||||0.14|TWO_SIDED|95.0|-1.86|13.17||P-value is for Evening Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||13.17|-1.86|0.140
74061848|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|11.18||||0.02|TWO_SIDED|95.0|1.74|20.63||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||20.63|1.74|0.020
74061849|NCT01215955|147675750|SUPERIORITY_OR_OTHER||LS Mean Difference|9.01||||0.037|TWO_SIDED|95.0|0.53|17.49||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||17.49|0.53|0.037
74061850|NCT01215955|147675751|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15||||0.543|TWO_SIDED|95.0|-2.55|4.84||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||4.84|-2.55|0.543
74061851|NCT01215955|147675751|SUPERIORITY_OR_OTHER||LS Mean Difference|6.72||||0.095|TWO_SIDED|95.0|-1.17|14.6||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||14.60|-1.17|0.095
74061852|NCT01215955|147675751|SUPERIORITY_OR_OTHER||LS Mean Difference|8.86||||0.059|TWO_SIDED|95.0|-0.35|18.06||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||18.06|-0.35|0.059
73888245|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.23|||<|0.0001|TWO_SIDED|95.0|-8.54|-5.93|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-5.93|-8.54|<0.0001
74061853|NCT01215955|147675751|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09||||0.497|TWO_SIDED|95.0|-2.05|4.23||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||4.23|-2.05|0.497
74061854|NCT01215955|147675751|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37||||0.156|TWO_SIDED|95.0|-2.06|12.79||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||12.79|-2.06|0.156
74061855|NCT01215955|147675751|SUPERIORITY_OR_OTHER||LS Mean Difference|6.05||||0.222|TWO_SIDED|95.0|-3.67|15.76||P-value of for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||15.76|-3.67|0.222
74061856|NCT01215955|147675752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.442|TWO_SIDED|95.0|-0.02|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference|||||0.05|-0.02|0.442
74061857|NCT01215955|147675752|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.037|TWO_SIDED|95.0|0.0|0.14||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.14|0.00|0.037
74061858|NCT01215955|147675752|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|||<|0.001|TWO_SIDED|95.0|0.05|0.16||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.16|0.05|<0.001
74061859|NCT01215955|147675752|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.275|TWO_SIDED|95.0|-0.01|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference|||||0.05|-0.01|0.275
74061860|NCT01215955|147675752|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.194|TWO_SIDED|95.0|-0.02|0.08||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.08|-0.02|0.194
74061861|NCT01215955|147675752|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.245|TWO_SIDED|95.0|-0.04|0.15||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.15|-0.04|0.245
74061862|NCT01215955|147675753|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.435
74061863|NCT01215955|147675753|SUPERIORITY_OR_OTHER|||||||0.351||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.351
74061864|NCT01215955|147675754|SUPERIORITY_OR_OTHER|||||||0.802||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.802
74061865|NCT01215955|147675754|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.205
74061866|NCT01215955|147675755|SUPERIORITY_OR_OTHER||Q3D vs Q1D Ratio of Negative Binomial|1.06||||0.586|TWO_SIDED|95.0|0.86|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial Regression|||||1.30|0.86|0.586
74061867|NCT01215955|147675755|SUPERIORITY_OR_OTHER||Q3D vs Q1D Ratio Negative Binomial|1.05||||0.689|TWO_SIDED|95.0|0.84|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial|||||1.30|0.84|0.689
74061868|NCT01215955|147675756|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.258
74061869|NCT01215955|147675756|SUPERIORITY_OR_OTHER|||||||0.856||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.856
74061870|NCT01523301|147675757|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.12|||=|0.1286|TWO_SIDED|95.0|-2.56|0.33||The null hypothesis was assessed with a 2-sided test and not rejected at p≤0.05.|ANCOVA|||The change from Baseline to the end of the Maintenance period in the score of the HAM-D of rotigotine-treated subjects has been compared with those subjects on placebo in the EES. The null hypothesis (H0) was that there was no difference in the change of the HAM-D score between the active treatment and the placebo group. The alternative hypothesis (H1) was that there was a difference in the change of HAM-D score between the rotigotine and the placebo arm.||0.33|-2.56|=0.1286
74061871|NCT01447628|147675764|SUPERIORITY|||||||0.6039|||||||Mixed Models Analysis|||||||0.6039
74061872|NCT01447628|147675765|SUPERIORITY|||||||0.0747|||||||Mixed Models Analysis|||||||0.0747
74061873|NCT01447628|147675765|SUPERIORITY|||||||0.799|||||||Mixed Models Analysis|||||||0.7990
74061874|NCT01447628|147675765|SUPERIORITY|||||||0.2111|||||||Mixed Models Analysis|||This is a combination of the p-values from the separate analyses of each data set.||||0.2111
74061875|NCT01447628|147675766|SUPERIORITY|||||||0.6583|||||||Mixed Models Analysis|||||||0.6583
74061876|NCT01447628|147675766|SUPERIORITY|||||||0.9166|||||||Mixed Models Analysis|||||||0.9166
74061877|NCT01447628|147675766|SUPERIORITY|||||||0.6631|||||||Mixed Models Analysis|||||||0.6631
74061878|NCT01447628|147675767|SUPERIORITY|||||||0.4039|||||||Mixed Models Analysis|||||||0.4039
74061879|NCT01447628|147675767|SUPERIORITY|||||||0.9144|||||||Mixed Models Analysis|||||||0.9144
74061880|NCT01447628|147675767|SUPERIORITY|||||||0.9959|||||||Mixed Models Analysis|||||||0.9959
74061881|NCT01447628|147675768|SUPERIORITY|||||||0.1788|||||||Mixed Models Analysis|||||||0.1788
74061882|NCT01447628|147675768|SUPERIORITY|||||||0.7795|||||||Mixed Models Analysis|||||||0.7795
74061883|NCT01447628|147675768|SUPERIORITY|||||||0.414|||||||Mixed Models Analysis|||||||0.414
74061884|NCT01447628|147675769|SUPERIORITY|||||||0.8688|||||||Mixed Models Analysis|||||||0.8688
74061885|NCT01447628|147675769|SUPERIORITY|||||||0.9999|||||||Mixed Models Analysis|||||||0.9999
74061886|NCT01447628|147675769|SUPERIORITY|||||||0.991|||||||Mixed Models Analysis|||||||0.991
74061887|NCT01447628|147675770|SUPERIORITY|||||||0.5465|||||||Mixed Models Analysis|||||||0.5465
74061888|NCT01447628|147675770|SUPERIORITY|||||||0.4298|||||||Mixed Models Analysis|||||||0.4298
74061889|NCT01447628|147675770|SUPERIORITY|||||||0.5451|||||||Mixed Models Analysis|||||||0.5451
74061890|NCT01447628|147675771|SUPERIORITY|||||||0.6241|||||||Mixed Models Analysis|||Note that Endurance CPET was not done in China, hence only European data provided.||||0.6241
74061891|NCT01447628|147675772|SUPERIORITY|||||||0.4758|||||||Mixed Models Analysis|||||||0.4758
74061892|NCT01447628|147675773|SUPERIORITY|||||||0.205|||||||Mixed Models Analysis|||||||0.2050
74061893|NCT01447628|147675773|SUPERIORITY|||||||0.1993|||||||Mixed Models Analysis|||||||0.1993
74061894|NCT01447628|147675773|SUPERIORITY|||||||0.1993|||||||Mixed Models Analysis|||||||0.1993
74061895|NCT01447628|147675774|SUPERIORITY|||||||0.061|||||||Mixed Models Analysis|||||||0.0610
74061896|NCT01447628|147675774|SUPERIORITY|||||||0.0641|||||||Mixed Models Analysis|||||||0.0641
74061897|NCT01447628|147675775|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
74061898|NCT01447628|147675775|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
74061899|NCT01447628|147675775|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74061900|NCT01447628|147675776|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74061901|NCT01447628|147675777|SUPERIORITY|||||||0.8093|||||||Mixed Models Analysis|||||||0.8093
74061902|NCT01447628|147675777|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|||||||0.6300
74061903|NCT01447628|147675777|SUPERIORITY|||||||0.8533|||||||Mixed Models Analysis|||||||0.8533
74061904|NCT01447628|147675778|SUPERIORITY|||||||0.0725|||||||Mixed Models Analysis|||||||0.0725
74061905|NCT01447628|147675778|SUPERIORITY|||||||0.8572|||||||Mixed Models Analysis|||||||0.8572
74061906|NCT01447628|147675778|SUPERIORITY|||||||0.2348|||||||Mixed Models Analysis|||||||0.2348
74061907|NCT01447628|147675779|SUPERIORITY|||||||0.1115|||||||Mixed Models Analysis|||||||0.1115
74061908|NCT01447628|147675780|SUPERIORITY|||||||0.979|||||||Mixed Models Analysis|||||||0.9790
74061909|NCT01447628|147675781|SUPERIORITY|||||||0.7702|||||||Mixed Models Analysis|||||||0.7702
74061910|NCT01447628|147675782|SUPERIORITY|||||||0.2219|||||||Mixed Models Analysis|||||||0.2219
74061911|NCT01447628|147675783|SUPERIORITY|||||||0.1777|||||||Mixed Models Analysis|||||||0.1777
74061912|NCT01447628|147675783|SUPERIORITY|||||||0.7889|||||||Mixed Models Analysis|||||||0.7889
74061913|NCT01447628|147675783|SUPERIORITY|||||||0.4156|||||||Mixed Models Analysis|||||||0.4156
74061914|NCT01447628|147675784|SUPERIORITY|||||||0.7625|||||||Mixed Models Analysis|||||||0.7625
74061915|NCT01447628|147675784|SUPERIORITY|||||||0.2262|||||||Mixed Models Analysis|||||||0.2262
74061916|NCT01447628|147675784|SUPERIORITY|||||||0.4756|||||||Mixed Models Analysis|||||||0.4756
74061917|NCT01447628|147675785|SUPERIORITY|||||||0.7711|||||||Mixed Models Analysis|||||||0.7711
74061918|NCT01447628|147675785|SUPERIORITY|||||||0.7806|||||||Mixed Models Analysis|||||||0.7806
74061919|NCT01447628|147675785|SUPERIORITY|||||||0.9074|||||||Mixed Models Analysis|||||||0.9074
74061920|NCT01447628|147675786|SUPERIORITY|||||||0.9504|||||||Mixed Models Analysis|||||||0.9504
74061921|NCT01447628|147675786|SUPERIORITY|||||||0.8666|||||||Mixed Models Analysis|||||||0.8666
74061922|NCT01447628|147675786|SUPERIORITY|||||||0.8104|||||||Mixed Models Analysis|||||||0.8104
74061923|NCT01447628|147675787|SUPERIORITY|||||||0.4478|||||||Mixed Models Analysis|||||||0.4478
74061924|NCT01447628|147675788|SUPERIORITY|||||||0.459|||||||Mixed Models Analysis|||||||0.4590
74061925|NCT01447628|147675789|SUPERIORITY|||||||0.8086|||||||Mixed Models Analysis|||||||0.8086
74061926|NCT01447628|147675790|SUPERIORITY|||||||0.6944|||||||Mixed Models Analysis|||||||0.6944
74061927|NCT01447628|147675791|SUPERIORITY|||||||0.585|||||||Mixed Models Analysis|||||||0.585
74061928|NCT01447628|147675792|SUPERIORITY|||||||0.4619|||||||Mixed Models Analysis|||||||0.4619
74061929|NCT01447628|147675793|SUPERIORITY|||||||0.7721|||||||Mixed Models Analysis|||||||0.7721
74061930|NCT01447628|147675794|SUPERIORITY|||||||0.8332|||||||Mixed Models Analysis|||||||0.8332
74061931|NCT01447628|147675795|SUPERIORITY|||||||0.2651|||||||Mixed Models Analysis|||||||0.2651
74061932|NCT00396981|147675805|NON_INFERIORITY_OR_EQUIVALENCE|This study used a non-inferiority design to demonstrate that the Matrix Coil is non-inferior to the GDC Coil, with a clinically acceptable non-inferiority margin set at 10%. Non-inferiority was used to establish the baseline estimate, which future superiority studies could be conducted. Non-inferiority was shown with a one-sided 95% CI of the difference less than the pre-specified 10% margin||||||0.76|||||||Log Rank|||Intent-to-Treat, All Subjects (N=626) GDC (N=315) Matrix (N=311) All Subjects (N=626) Subjects Who Met Primary Endpoint 35 (11.1%) 34 (10.9%) 69 (11.0%)||||0.76
74061933|NCT00639158|147675812|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A sample size of 212 per arm provided 90% power and \> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.||||< 0.001
74061934|NCT00639158|147675813|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||0.004
74061935|NCT00639158|147675814|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||A sample size of 212 per arm provided 90% power and \> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.||||< 0.001
74061936|NCT00639158|147675815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
74061937|NCT00639158|147675816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
74061938|NCT00639158|147675817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
74061939|NCT00639158|147675818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
74061940|NCT00639158|147675819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|Rank-sum test||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
74061941|NCT02149199|147676007|SUPERIORITY||Odds Ratio (OR)|1.14||||0.046|TWO_SIDED|95.0|1.0|1.3|||Regression, Logistic|Repeated measures logistic regression, with treatment, pre-study treatment, region and study week as fixed effects.|An odds ratio greater than 1 favours Symbicort 'as needed'|||1.30|1.00|0.046
74061942|NCT02149199|147676007|NON_INFERIORITY|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Lower limit of the 2-sided 95% CI \>=0.8 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid.|Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.57|0.73|||Regression, Logistic|Repeated measures logistic regression with treatment, pre-study treatment, region and study week as fixed effects.||||0.73|0.57|
74061943|NCT02149199|147676008|SUPERIORITY||Hazard Ratio (HR)|0.435|||<|0.001|TWO_SIDED|95.0|0.328|0.577|||Regression, Cox|Cox-regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0, \>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||0.577|0.328|<0.001
74061944|NCT02149199|147676008|SUPERIORITY||Hazard Ratio (HR)|0.901||||0.524|TWO_SIDED|95.0|0.653|1.242|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||1.242|0.653|0.524
74061945|NCT02149199|147676009|SUPERIORITY||Hazard Ratio (HR)|0.429|||<|0.001|TWO_SIDED|95.0|0.348|0.528|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.|||0.528|0.348|<0.001
74061946|NCT02149199|147676009|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.436|TWO_SIDED|95.0|0.718|1.153|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.|||1.153|0.718|0.436
74061947|NCT02149199|147676010|SUPERIORITY||Mean Difference (Net)|53.8|||<|0.001|TWO_SIDED|95.0|29.1|78.5|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.|||78.5|29.1|<0.001
74061948|NCT02149199|147676010|SUPERIORITY||Mean Difference (Net)|-54.3|||<|0.001|TWO_SIDED|95.0|-78.8|-29.8|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.|||-29.8|-78.8|<0.001
74061949|NCT02149199|147676011|SUPERIORITY||Mean Difference (Net)|11.95|||<|0.001|TWO_SIDED|95.0|7.89|16.0|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||16.00|7.89|<0.001
74061950|NCT02149199|147676011|SUPERIORITY||Mean Difference (Net)|-9.98|||<|0.001|TWO_SIDED|95.0|-14.03|-5.93|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-5.93|-14.03|<0.001
74061951|NCT02149199|147676012|SUPERIORITY||Mean Difference (Net)|10.94|||<|0.001|TWO_SIDED|95.0|6.99|14.9|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||14.90|6.99|<0.001
74061952|NCT02149199|147676012|SUPERIORITY||Mean Difference (Net)|-6.23||||0.002|TWO_SIDED|95.0|-10.18|-2.29|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-2.29|-10.18|0.002
74061953|NCT02149199|147676014|SUPERIORITY||Mean Difference (Net)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.18|-0.06|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||-0.06|-0.18|<0.001
73882382|NCT00286442|147298763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.1|||<|0.001|TWO_SIDED|95.0|-26.7|-9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.4|-26.7|<0.001
73882383|NCT00286442|147298763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-24.2|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.8|-24.2|<0.001
74061954|NCT02149199|147676014|SUPERIORITY||Mean Difference (Net)|0.09||||0.004|TWO_SIDED|95.0|0.03|0.15|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||0.15|0.03|0.004
73888246|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9|||<|0.0001|TWO_SIDED|95.0|-9.2|-6.59|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-6.59|-9.20|<0.0001
74061955|NCT02149199|147676021|SUPERIORITY||Hazard Ratio (HR)|0.413|||<|0.001|TWO_SIDED|95.0|0.343|0.497|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.|||0.497|0.343|<0.001
74061956|NCT02149199|147676021|SUPERIORITY||Hazard Ratio (HR)|0.865||||0.175|TWO_SIDED|95.0|0.701|1.067|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.|||1.067|0.701|0.175
74061957|NCT02149199|147676022|SUPERIORITY||Mean Difference (Net)|-0.154|||<|0.001|TWO_SIDED|95.0|-0.203|-0.105|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.|||-0.105|-0.203|<0.001
74061958|NCT02149199|147676022|SUPERIORITY||Mean Difference (Net)|0.149|||<|0.001|TWO_SIDED|95.0|0.101|0.198|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.|||0.198|0.101|<0.001
74061959|NCT02149199|147676023|SUPERIORITY||Mean Difference (Net)|0.127|||<|0.001|TWO_SIDED|95.0|0.074|0.181|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.|||0.181|0.074|<0.001
74061960|NCT02149199|147676023|SUPERIORITY||Mean Difference (Net)|-0.102|||<|0.001|TWO_SIDED|95.0|-0.155|-0.049|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.|||-0.049|-0.155|<0.001
74061961|NCT02149199|147676025|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.27|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.|||0.49|0.27|<0.001
74061962|NCT02149199|147676025|SUPERIORITY||Rate ratio|0.83||||0.279|TWO_SIDED|95.0|0.59|1.16|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.|||1.16|0.59|0.279
74061963|NCT02149199|147676026|SUPERIORITY||Rate ratio|0.4|||<|0.001|TWO_SIDED|95.0|0.32|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.|||0.49|0.32|<0.001
74061964|NCT02149199|147676026|SUPERIORITY||Rate ratio|0.95||||0.663|TWO_SIDED|95.0|0.74|1.21|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.|||1.21|0.74|0.663
74061965|NCT01500434|147676080|NON_INFERIORITY_OR_EQUIVALENCE|Study had 85% statistical power to demonstrate that the 12-month rate for TLF (accounting for an expected 1-year attrition rate of 5%) is less than the performance goal, assuming a 1-year TLF rate of 9.0%.|Target Lesion Failure Rate|3.2|||<|0.0001|ONE_SIDED|95.0||7.96|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 19.4%.||7.96||<0.0001
74061966|NCT01966107|147676109|SUPERIORITY||Rate ratio|0.65||||0.006|TWO_SIDED|95.0|0.48|0.89|||Negative Binomial Regression model||||A rate ratio \<1 represents a favorable outcome for aclidinium bromide 400 μg.|0.89|0.48|0.006
74061967|NCT01966107|147676111|NON_INFERIORITY|Estimate of the hazard ratio and its 95% CI for comparing aclidinium bromide 400 μg versus placebo were derived using the Cox proportional hazard model. A hazard ratio \<1 represents a favorable outcome for aclidinium bromide 400 μg.|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.64|1.23||||||Composite MACE||1.23|0.64|
74061968|NCT00532779|147676112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.67|||<|0.001||95.0|-4.5|-2.85|||ANCOVA|||||-2.85|-4.50|<0.001
74061969|NCT00532779|147676112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.81|||<|0.001|TWO_SIDED|95.0|-5.63|-3.99|||ANCOVA|||||-3.99|-5.63|<0.001
74061970|NCT00532779|147676113|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42|||<|0.001||95.0|2.52|4.63|||Regression, Logistic|||||4.63|2.52|<0.001
74061971|NCT00532779|147676113|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.86|||<|0.001||95.0|3.6|6.57|||Regression, Logistic|||||6.57|3.60|<0.001
74061972|NCT00532779|147676114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|2.14|4.81|||Regression, Logistic|||||4.81|2.14|<0.001
74061973|NCT00532779|147676114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.001|TWO_SIDED|95.0|2.82|6.23|||Regression, Logistic|||||6.23|2.82|<0.001
74061974|NCT00532779|147676115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.74|-1.43|||ANCOVA|||||-1.43|-3.74|<0.001
74061975|NCT00532779|147676115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.78|||<|0.001|TWO_SIDED|95.0|-4.93|-2.64|||ANCOVA|||||-2.64|-4.93|<0.001
74061976|NCT00532779|147676116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.42|||<|0.001|TWO_SIDED|95.0|2.17|4.66|||ANCOVA|||||4.66|2.17|<0.001
74061977|NCT00532779|147676116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.48|||<|0.001|TWO_SIDED|95.0|2.26|4.7|||ANCOVA|||||4.70|2.26|<0.001
74061978|NCT00532779|147676117|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.88|||=|0.046|TWO_SIDED||||||ANCOVA|||||||=0.046
74061979|NCT00532779|147676117|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.61|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
74061980|NCT00532779|147676118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.13|||<|0.001|TWO_SIDED|95.0|1.72|4.54|||ANCOVA|||||4.54|1.72|<0.001
74061981|NCT00532779|147676118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.14|||<|0.001|TWO_SIDED|95.0|2.73|5.56|||ANCOVA|||||5.56|2.73|<0.001
74061982|NCT00532779|147676119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.36|||=|0.016|TWO_SIDED||||||ANCOVA|||||||=0.016
74061983|NCT00532779|147676119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.32|||=|0.008|TWO_SIDED||||||ANCOVA|||||||=0.008
74061984|NCT00532779|147676120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.27|||=|0.063|TWO_SIDED||||||ANCOVA|||||||=0.063
74061985|NCT00532779|147676120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.57|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
73882384|NCT00286442|147298764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|||<|0.001|TWO_SIDED|95.0|-27.3|-10.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.2|-27.3|<0.001
73882385|NCT00286442|147298764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.9|-8.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.8|-25.9|<0.001
73882386|NCT00286442|147298765|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.372|||<|0.001|TWO_SIDED|95.0|0.213|0.65||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.650|0.213|<0.001
73882387|NCT00286442|147298765|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.405||||0.002|TWO_SIDED|95.0|0.231|0.708||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.708|0.231|0.002
73882388|NCT00286442|147298766|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.302||||0.002|TWO_SIDED|95.0|0.143|0.635||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.635|0.143|0.002
73882389|NCT00286442|147298766|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.236|||<|0.001|TWO_SIDED|95.0|0.109|0.51|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.510|0.109|<0.001
73882390|NCT00286442|147298767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.634|TWO_SIDED|95.0|-7.4|4.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.5|-7.4|0.634
73882391|NCT00286442|147298767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.136|TWO_SIDED|95.0|-10.5|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.4|-10.5|0.136
73882392|NCT00286442|147298768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.274|TWO_SIDED|95.0|-6.9|2.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.0|-6.9|0.274
73882393|NCT00286442|147298768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.046|TWO_SIDED|95.0|-9.1|-0.1||No multiplicity adjustments.|ANCOVA||Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.1|-9.1|0.046
74061986|NCT00532779|147676121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|||||TWO_SIDED|95.0|-2.6|0.42||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.42|-2.60|
73882394|NCT00286442|147298769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.655|TWO_SIDED|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-7.4|0.655
73882395|NCT00286442|147298769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.645|TWO_SIDED|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-7.4|0.645
73882396|NCT00286442|147298770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.748|TWO_SIDED|95.0|-6.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-6.3|0.748
74061987|NCT00532779|147676121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.94|||=|0.01|TWO_SIDED|95.0|-3.42|-0.46|||ANCOVA|||||-0.46|-3.42|=0.010
74061988|NCT00532779|147676122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.43|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
74061989|NCT00532779|147676122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.29|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
74061990|NCT00532779|147676123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.81|||||TWO_SIDED|95.0|-6.68|-0.94||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.94|-6.68|
74061991|NCT00532779|147676123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.84|||<|0.001|TWO_SIDED|95.0|-8.71|-2.98|||ANCOVA|||||-2.98|-8.71|<0.001
74061992|NCT00532779|147676124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|||||TWO_SIDED|95.0|-3.62|2.84||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.84|-3.62|
74061993|NCT00532779|147676124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.484|TWO_SIDED|95.0|-4.29|2.04|||ANCOVA|||||2.04|-4.29|0.484
73882397|NCT00286442|147298770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.432|TWO_SIDED|95.0|-7.7|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.3|-7.7|0.432
73882398|NCT00286442|147298771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.427|TWO_SIDED|95.0|-7.8|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.3|-7.8|0.427
73882399|NCT00286442|147298771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.746|TWO_SIDED|95.0|-4.6|6.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.5|-4.6|0.746
73882400|NCT00286442|147298772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.727|TWO_SIDED|95.0|-5.0|7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.2|-5.0|0.727
73882401|NCT00286442|147298772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.601||||1.6|TWO_SIDED|95.0|-4.5|7.8||No multiplicity adjustments|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.8|-4.5|1.6
73882402|NCT00286442|147298773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19||||0.066|TWO_SIDED|95.0|-0.15|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.52|-0.15|0.066
73882403|NCT00286442|147298773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.18|TWO_SIDED|95.0|-0.74|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.93|-0.74|0.180
73882404|NCT00286442|147298774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.944|TWO_SIDED|95.0|-5.02|4.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.68|-5.02|0.944
73882405|NCT00286442|147298774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.316|TWO_SIDED|95.0|-7.4|2.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.40|-7.40|0.316
73882406|NCT00286442|147298775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.901|TWO_SIDED|95.0|-5.42|4.77||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.77|-5.42|0.901
74061994|NCT00532779|147676125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.23|||||TWO_SIDED|95.0|1.16|3.3||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.30|1.16|
74061995|NCT00532779|147676125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83|||||TWO_SIDED|95.0|0.76|2.9||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.90|0.76|
74061996|NCT00532779|147676126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.19|1.73||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.73|0.19|
74061997|NCT00532779|147676126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|0.13|1.67||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.67|0.13|
74061998|NCT00532779|147676127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.19|1.28||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.28|0.19|
73882407|NCT00286442|147298775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45||||0.578|TWO_SIDED|95.0|-6.59|3.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.68|-6.59|0.578
73888247|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.24|||<|0.0001|TWO_SIDED|95.0|-12.55|-9.94|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.94|-12.55|<0.0001
74061999|NCT00532779|147676127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|-0.09|1.0||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.00|-0.09|
73882408|NCT00286442|147298776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.708|TWO_SIDED|95.0|-2.67|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.93|-2.67|0.708
74062000|NCT00532779|147676128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|0.14|1.23||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.23|0.14|
73888248|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.35|||<|0.0001|TWO_SIDED|95.0|-7.65|-5.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-5.05|-7.65|<0.0001
74062001|NCT00532779|147676128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.4|0.69||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.69|-0.40|
74062002|NCT00532779|147676129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.53|0.53||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.53|-0.53|
74062003|NCT00532779|147676129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.8|0.27||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.27|-0.80|
74062004|NCT01556165|147676134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.32||0.0254|TWO_SIDED|75.0|-4.53|-1.47||No adjustments for multiple comparisons were made.|ANCOVA|||This study was designed to show a trend, that is, to show a clinical difference in the primary efficacy analysis, at a two-sided significance level of 0.25. Assuming a difference between rasagiline and placebo of a 3-point change in the UPDRS total score and a standard deviation on the change from baseline of 7 points, a sample size of 60 patients per treatment group gave an 88% probability of showing a trend. LOCF (last observation carried forward) was used.||-1.47|-4.53|0.0254
74062005|NCT01556165|147676135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.21||0.0032|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||-0.21|-1.03|0.0032
74062006|NCT01556165|147676136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.52||0.1963|TWO_SIDED|95.0|-1.7|0.35|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||0.35|-1.70|0.1963
74062007|NCT01556165|147676137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.91||0.0641|TWO_SIDED|95.0|-3.52|0.1|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||0.10|-3.52|0.0641
74062008|NCT02787746|147676159|OTHER||Odds Ratio (OR)|0.988||||0.9744|TWO_SIDED|95.0|0.466|2.095|||Regression, Logistic|||Age (\>75y vs ≤75y）||2.095|0.466|0.9744
74062009|NCT02787746|147676159|OTHER||Odds Ratio (OR)|3.42||||0.3288|TWO_SIDED|95.0|0.29|40.354|||Regression, Logistic|||APOE ɛ4 (carrier vs non-carrier)||40.354|0.290|0.3288
74062010|NCT02787746|147676159|OTHER||Odds Ratio (OR)|2.107||||0.5732|TWO_SIDED|95.0|0.158|28.171|||Regression, Logistic|||Concomitant medication：Gastrointestinal drugs||28.171|0.158|0.5732
74062011|NCT02787746|147676159|OTHER||Odds Ratio (OR)|0.976||||0.9694|TWO_SIDED|95.0|0.281|3.387|||Regression, Logistic|||Concomitant medication：Hypoglycemic drugs||3.387|0.281|0.9694
74062012|NCT02787746|147676159|OTHER||Odds Ratio (OR)|2.221||||0.0396|TWO_SIDED|95.0|1.039|4.748|||Regression, Logistic|||Concomitant medication：Cardiovascular and Cerebrovascular drugs||4.748|1.039|0.0396
74062013|NCT02787746|147676159|OTHER||Odds Ratio (OR)|2.056||||0.5889|TWO_SIDED|95.0|0.151|28.074|||Regression, Logistic|||Concomitant medication：Hepatology drugs||28.074|0.151|0.5889
74062014|NCT02787746|147676159|OTHER||Odds Ratio (OR)|1.004||||0.1181|TWO_SIDED|95.0|0.999|1.008|||Regression, Logistic|||Duration of previous donepezil 5mg/d therapy (day)||1.008|0.999|0.1181
74062015|NCT01788163|147676193|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|81.1237||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for entry criteria||||||0.0001
74062016|NCT01788163|147676193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.973||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for model entry||||||0.0001
74062017|NCT01788163|147676193|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|7.1526||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% significance level for entry criteria||||||0.0075
74062018|NCT01788163|147676193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.409||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% Significance Level for model entry||||||0.0075
74062019|NCT01788163|147676193|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|51.8456||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% significance level for entry criteria||||||0.0001
74062020|NCT01788163|147676193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.515||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry||||||0.0001
74062021|NCT01788163|147676193|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|98.1065||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
74062022|NCT01788163|147676193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.929||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry||||||0.0001
74062023|NCT01788163|147676193|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|2.8589||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for entry criteria||||||0.0909
74062024|NCT01788163|147676193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.086||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for model entry||||||0.0909
74062025|NCT01788163|147676196|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|11.106||||0.0009||||||Age: \<=65 vs. \>65|Regression Stepwise|10% Significance Level for entry criteria||||||0.0009
74062026|NCT01788163|147676196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.561||||0.0009||||||Age: \<=65 vs. \>65|Regression Stepwise|10% Significance Level for model entry||||||0.0009
74062027|NCT01788163|147676196|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|34.1075||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
74062028|NCT01788163|147676196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.386||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% significance level for model entry||||||0.0001
74062029|NCT01788163|147676196|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|14.0806||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for entry criteria||||||0.0002
74062030|NCT01788163|147676196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.955||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for model entry||||||0.0002
74062031|NCT01788163|147676196|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|33.8574||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
74062032|NCT01788163|147676196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.077||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry||||||0.0001
74062033|NCT01788163|147676196|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|21.2537||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
74062034|NCT01788163|147676196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.084||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry||||||0.0001
74062035|NCT03610646|147676205|EQUIVALENCE|An equivalence margin of \[-3, 3\] letters was used to demonstrate equivalence for the difference of mean change in BCVA, from baseline to Week 8.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|-1.16|1.24||||||||1.24|-1.16|
74062036|NCT02007369|147676290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21||||0.033|TWO_SIDED|95.0|0.05|0.89|||Regression, Logistic|||||0.89|0.05|0.033
74062037|NCT02007369|147676290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.934|TWO_SIDED|95.0|0.36|3.01|||Regression, Logistic|||||3.01|0.36|0.934
74062038|NCT02007369|147676291|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|||||||0.002
74062039|NCT02007369|147676291|SUPERIORITY_OR_OTHER|||||||0.199|||||||Fisher Exact|||||||0.199
74062040|NCT02007369|147676292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.285|TWO_SIDED|95.0|0.25|1.5|||Regression, Logistic|||||1.50|0.25|0.285
74062041|NCT02007369|147676292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.597|TWO_SIDED|95.0|0.31|1.97|||Regression, Logistic|||||1.97|0.31|0.597
74062042|NCT02007369|147676293|SUPERIORITY_OR_OTHER|||||||0.023|||||||Fisher Exact|||||||0.023
74062043|NCT02007369|147676293|SUPERIORITY_OR_OTHER|||||||0.527|||||||Fisher Exact|||||||0.527
74062044|NCT01336608|147676310|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.01||||0.969|TWO_SIDED|95.0|-0.71|0.74|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.74|-0.71|0.969
74062045|NCT01336608|147676310|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.22||||0.568|TWO_SIDED|95.0|-0.53|0.96|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.96|-0.53|0.568
74062046|NCT01336608|147676310|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.2||||0.566|TWO_SIDED|95.0|-0.49|0.89|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.89|-0.49|0.566
74062047|NCT01336608|147676311|SUPERIORITY_OR_OTHER||Least squares mean difference|0.082||||0.007|TWO_SIDED|95.0|0.023|0.141||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.141|0.023|0.007
74062048|NCT01336608|147676311|SUPERIORITY_OR_OTHER||Least squares mean difference|0.155|||<|0.001|TWO_SIDED|95.0|0.095|0.215||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.215|0.095|<0.001
74062049|NCT01336608|147676311|SUPERIORITY_OR_OTHER||Least squares mean difference|0.074||||0.012|TWO_SIDED|95.0|0.016|0.131||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.131|0.016|0.012
74062050|NCT01336608|147676312|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.22||Nominal p-value|ANCOVA|||||-0.22|-0.72|<0.001
74062051|NCT01336608|147676312|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.76|-0.24||Nominal p-value|ANCOVA|||||-0.24|-0.76|<0.001
74062052|NCT01336608|147676312|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03||||0.803|TWO_SIDED|95.0|-0.29|0.22|||ANCOVA|||||0.22|-0.29|0.803
74062053|NCT02253654|147676313|SUPERIORITY_OR_OTHER||Treatment difference|0.39|STANDARD_ERROR_OF_MEAN|3.53||0.46|ONE_SIDED|97.5|-6.58||||t-test, 1 sided|||The difference between treatment groups for the percent of hemoglobin measurements within 10.0 to 11.0 g/dL during the evaluation period was tested using a 1-sided t-test with a significance level of 0.025.|||-6.58|0.46
74062054|NCT00069160|147676323|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>.05
74062055|NCT02576054|147676378|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.0|1.57|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 6||1.57|1.00|<0.001
74062056|NCT02576054|147676378|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|2.3|||<|0.001|TWO_SIDED|95.0|1.89|2.78|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio = GMT PN200 divided by GMT PN122|Anti-HPV 11||2.78|1.89|<0.001
73882409|NCT00286442|147298776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.601|TWO_SIDED|95.0|-2.44|4.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.21|-2.44|0.601
73882410|NCT00286442|147298777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12||||0.398|TWO_SIDED|95.0|-1.48|3.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.72|-1.48|0.398
73882411|NCT00286442|147298777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.425|TWO_SIDED|95.0|-1.56|3.69||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.69|-1.56|0.425
73882412|NCT00286442|147298778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87||||0.018|TWO_SIDED|95.0|0.5|5.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.23|0.50|0.018
73882413|NCT00286442|147298778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.067|TWO_SIDED|95.0|-0.15|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.60|-0.15|0.067
73882414|NCT00286442|147298779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036||||0.011|TWO_SIDED|95.0|-0.064|-0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.009|-0.064|0.011
73882415|NCT00286442|147298779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047|||<|0.001|TWO_SIDED|95.0|-0.075|-0.019||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.019|-0.075|<0.001
73882416|NCT00286442|147298780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||<|0.001|TWO_SIDED|95.0|-0.07|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.021|-0.070|<0.001
73882417|NCT00286442|147298780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.004|TWO_SIDED|95.0|-0.062|-0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.012|-0.062|0.004
73888249|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.36|||<|0.0001|TWO_SIDED|95.0|-11.67|-9.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.05|-11.67|<0.0001
73882418|NCT00286442|147298781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.007|TWO_SIDED|95.0|-0.068|-0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm|||-0.011|-0.068|0.007
74062057|NCT02576054|147676378|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.69|||<|0.001|TWO_SIDED|95.0|1.35|2.11|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 16||2.11|1.35|<0.001
74062058|NCT02576054|147676378|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|3.05|||<|0.001|TWO_SIDED|95.0|2.33|3.99|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 18||3.99|2.33|<0.001
74062059|NCT01190098|147676400|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: there is a non-inferiority region of 4 points.||||||0.027|||||||t-test, 1 sided|||||||0.027
74062060|NCT01190098|147676401|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.7||||0.23|TWO_SIDED||||||t-test, 2 sided|||||||0.23
74062061|NCT01190098|147676402|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.84|TWO_SIDED||||||t-test, 2 sided|||||||0.84
74062062|NCT01190098|147676403|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.37|TWO_SIDED||||||t-test, 2 sided|||||||0.37
74062063|NCT01190098|147676404|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.8||||0.33|TWO_SIDED||||||t-test, 2 sided|||||||0.33
74062064|NCT01190098|147676405|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.92|TWO_SIDED||||||t-test, 2 sided|||||||0.92
74062065|NCT01190098|147676406|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.69
74062066|NCT01190098|147676407|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
74062067|NCT02957682|147676408|NON_INFERIORITY|Upper confidence interval (CI) limit was compared to the noninferiority margin, which was 0.2%, and noninferiority was declared if the upper CI limit was below the noninferiority margin.|Least Square (LS) Mean Difference|-0.02||||0.6055|TWO_SIDED|95.0|-0.094|0.055||P-value was taken from mixed-effect model with repeated measures (MMRM) analysis.|Mixed-effect Model Repeated Measures||Model: fixed categorical effects of treatment group, randomization strata as per IVRS, time point, treatment-by-time point, strata-by-time point, continuous fixed covariates of baseline SWMS raw score value, baseline value by time-point interaction.|Change at Week 96||0.055|-0.094|0.6055
74062068|NCT00149669|147676427|SUPERIORITY||Odds Ratio (OR)|8.67|||<|0.01|TWO_SIDED|95.0|4.24|17.73|||General Estimating Equation (GEE)|||||17.73|4.24|<0.01
74062069|NCT00149669|147676428|SUPERIORITY||Odds Ratio (OR)|0.91||||0.82|TWO_SIDED|95.0|0.43|1.95|||General Estimating Equation (GEE)|||||1.95|.43|0.82
74062070|NCT00149669|147676429|SUPERIORITY||Odds Ratio (OR)|0.61|||=|0.19|TWO_SIDED|95.0|0.29|1.26|||General Estimating Equation (GEE)|||||1.26|0.29|=0.19
74062071|NCT02458365|147676434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.75|.51|<.0001
74062072|NCT02458365|147676434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.45|0.68|||Regression, Linear|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.68|.45|<.0001
74062073|NCT02458365|147676435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||<|0.001|TWO_SIDED|95.0|0.57|0.84|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.84|.57|<.001
74062074|NCT02458365|147676435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.5|0.75|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.75|.50|<.0001
74062075|NCT02458365|147676436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.43|0.67|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.67|.43|<.0001
74062076|NCT02458365|147676436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.36|0.56|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.56|.36|<.0001
74062077|NCT02458365|147676437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.41|0.62|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.62|.41|<.0001
74062078|NCT02458365|147676437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.54|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.54|.35|<.0001
74062079|NCT02458365|147676438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.001|TWO_SIDED|95.0|0.38|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.78|.38|.001
74062080|NCT02458365|147676438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.013|TWO_SIDED|95.0|0.4|0.9|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.90|.40|.013
73882419|NCT00286442|147298781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.011|TWO_SIDED|95.0|-0.066|-0.008||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm|||-0.008|-0.066|0.011
73882420|NCT00286442|147298782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052|||<|0.001|TWO_SIDED|95.0|-0.08|-0.024||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.024|-0.080|<0.001
73882421|NCT00286442|147298782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.003|TWO_SIDED|95.0|-0.072|-0.015||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.015|-0.072|0.003
73882422|NCT00286442|147298783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.078|TWO_SIDED|95.0|-0.097|0.005||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.005|-0.097|0.078
73882423|NCT00286442|147298783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005||||0.86|TWO_SIDED|95.0|-0.056|0.047||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.047|-0.056|0.860
73882424|NCT00286442|147298784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053||||0.048|TWO_SIDED|95.0|-0.106|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.001|-0.106|0.048
73882425|NCT00286442|147298784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004||||0.889|TWO_SIDED|95.0|-0.057|0.05||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.050|-0.057|0.889
73882426|NCT00286442|147298785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.336||||0.031|TWO_SIDED|95.0|0.03|0.642||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.642|0.030|0.031
73882427|NCT00286442|147298785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304||||0.051|TWO_SIDED|95.0|-0.002|0.611||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.611|-0.002|0.051
73882428|NCT00286442|147298786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.563|TWO_SIDED|95.0|-0.209|0.384||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.384|-0.209|0.563
73882429|NCT00286442|147298786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111||||0.467|TWO_SIDED|95.0|-0.188|0.41||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.410|-0.188|0.467
73888250|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.37|||<|0.0001|TWO_SIDED|95.0|-13.16|-9.58|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.58|-13.16|<0.0001
74062081|NCT02458365|147676439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|||<|0.001|TWO_SIDED|95.0|0.37|0.76|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.76|.37|<.001
74062082|NCT02458365|147676439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.004|TWO_SIDED|95.0|0.35|0.82|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.82|.35|.004
74062083|NCT02458365|147676440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.002|TWO_SIDED|95.0|0.35|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.78|.35|.002
74062084|NCT02458365|147676440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.005|TWO_SIDED|95.0|0.31|0.81|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.81|.31|.005
74062085|NCT02458365|147676441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.29|0.64|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.64|.29|<.0001
74062086|NCT02458365|147676441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.003|TWO_SIDED|95.0|0.29|0.77|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.77|.29|.003
74062087|NCT00390949|147676465|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjustments for community pair, age-group and value of variable at baseline||||||<0.05
74062088|NCT00390949|147676466|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value of variable at baseline||||||<0.05
74062089|NCT00390949|147676467|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|||||||<0.05
74062090|NCT00390949|147676468|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value at baseline||||||<0.05
74062091|NCT00390949|147676469|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair and age-group||||||<0.05
74062092|NCT00390949|147676470|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value at baseline||||||<0.05
74062093|NCT04840901|147676515|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.09|||||TWO_SIDED|90.0|1.03|1.16|||ANCOVA|||||1.16|1.03|
74062094|NCT04840901|147676516|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.07|||||TWO_SIDED|90.0|1.02|1.14|||ANCOVA|||||1.14|1.02|
73882430|NCT00286442|147298787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.243|TWO_SIDED|95.0|-0.127|0.501||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.501|-0.127|0.243
73882431|NCT00286442|147298787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.279||||0.083|TWO_SIDED|95.0|-0.037|0.595||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.595|-0.037|0.083
73882432|NCT00286442|147298788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155||||0.321|TWO_SIDED|95.0|-0.152|0.463||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.463|-0.152|0.321
74062095|NCT04840901|147676517|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.09|||||TWO_SIDED|90.0|1.03|1.14|||ANCOVA|||||1.14|1.03|
74062096|NCT02216214|147676538|SUPERIORITY||Least Squares Mean (LSM) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.33||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.33|-1.05|<0.001
74062097|NCT02216214|147676539|SUPERIORITY||LSM Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.82|-0.27||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.27|-0.82|<0.001
74062098|NCT02216214|147676540|SUPERIORITY||LSM Difference|13.68|STANDARD_ERROR_OF_MEAN|4.45||0.002|TWO_SIDED|95.0|4.95|22.42||P-value compares the Mirabegron group to the placebo group.|stratified rank ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the stratified rank ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||22.42|4.95|0.002
73882433|NCT00286442|147298788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268||||0.089|TWO_SIDED|95.0|-0.041|0.577||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.577|-0.041|0.089
73882434|NCT00286442|147298789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144||||0.305|TWO_SIDED|95.0|-0.132|0.42||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.420|-0.132|0.305
74062099|NCT02216214|147676541|SUPERIORITY||LSM Difference|-5.15|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|95.0|-7.84|-2.46||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-2.46|-7.84|<0.001
73888251|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.07|||<|0.0001|TWO_SIDED|95.0|-17.86|-14.28|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-14.28|-17.86|<0.0001
74062100|NCT02216214|147676542|SUPERIORITY||LSM Difference|2.72|STANDARD_ERROR_OF_MEAN|1.07||0.011|TWO_SIDED|95.0|0.62|4.83||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||4.83|0.62|0.011
74062101|NCT02216214|147676543|SUPERIORITY||LSM Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.46|-0.16||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.16|-0.46|<0.001
74062102|NCT02216214|147676544|SUPERIORITY||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||<0.001
74062103|NCT02216214|147676545|SUPERIORITY||Rate Ratio|0.68|||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||The rate ratio for the number of urgency incontinence episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group was calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and number of valid diary days as the offset variable.||||<0.001
74062104|NCT02216214|147676546|SUPERIORITY||Rate Ratio|0.84||||0.432||||||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||The rate ratio for the number of nocturia episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and number of valid diary days as the offset variable.||||0.432
74062105|NCT02216214|147676547|SUPERIORITY|||||||0.317||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.317
74062106|NCT02216214|147676548|SUPERIORITY|||||||0.165||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.165
74062107|NCT02216214|147676549|SUPERIORITY||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||<0.001
74062108|NCT02216214|147676550|SUPERIORITY|||||||0.019||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Coping Subscale Score||||0.019
74062109|NCT02216214|147676550|SUPERIORITY|||||||0.01||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Concern Subscale Score||||0.010
74062110|NCT02216214|147676550|SUPERIORITY|||||||0.006||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Sleep Subscale Score||||0.006
74062111|NCT02216214|147676550|SUPERIORITY|||||||0.614||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Social Subscale Score||||0.614
74062112|NCT02216214|147676551|SUPERIORITY|||||||0.002||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.002
74062113|NCT02216214|147676552|SUPERIORITY|||||||0.755||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.755
74062114|NCT02216214|147676553|SUPERIORITY||Rate Ratio|0.8||||0.014|TWO_SIDED|95.0|0.67|0.96||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 4: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.96|0.67|0.014
74062115|NCT02216214|147676553|SUPERIORITY||Rate Ratio|0.81||||0.043|TWO_SIDED|95.0|0.66|0.99||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 8: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.99|0.66|0.043
74062116|NCT02216214|147676553|SUPERIORITY||Rate Ratio|0.69||||0.002|TWO_SIDED|95.0|0.54|0.87||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||EOT: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.87|0.54|0.002
74062117|NCT02216214|147676555|SUPERIORITY||Odds Ratio (OR)|1.5||||0.005||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.005
74062118|NCT02216214|147676556|SUPERIORITY||Odds Ratio (OR)|1.775|||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||<0.001
74062119|NCT02216214|147676557|SUPERIORITY||Odds Ratio (OR)|1.501||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.012
74062120|NCT02216214|147676558|SUPERIORITY||Odds Ratio (OR)|1.39||||0.034||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Coping. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.034
74062121|NCT02216214|147676558|SUPERIORITY||Odds Ratio (OR)|1.327||||0.07||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Concern. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.070
74062122|NCT02216214|147676558|SUPERIORITY||Odds Ratio (OR)|1.452||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Sleep. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.012
74062123|NCT02216214|147676558|SUPERIORITY||Odds Ratio (OR)|1.116||||0.602||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Social. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.602
74062124|NCT02216214|147676559|SUPERIORITY||Odds Ratio (OR)|1.634||||0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.001
74062125|NCT02216214|147676560|SUPERIORITY||Odds Ratio (OR)|1.597||||0.003||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.003
74062126|NCT02216214|147676562|SUPERIORITY|||||||0.471||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.471
74062127|NCT05354206|147676565|SUPERIORITY||Mean Difference (Final Values)|0.405|STANDARD_DEVIATION|0.285|<|0.05|TWO_SIDED|||||p-values have not been adjusted for multiple comparisons|t-test, 2 sided||Difference of RST from 1 for hip range of motion task without stimulation.|"Reticulospinal tract (RST) contribution computed as RST = (visual - startle)/(visual - auditory) reaction times, where a RST value greater than 1 would indicate a significant contribution of the reticulospinal tract for a given task.~A one sample t-test (or Wilcoxon signed-rank test for non-normally distributed data) was used to test the hypothesis that the RST contribution for a given movement was significantly greater than 1."||||<0.05
74062128|NCT00713830|147676566|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.867|-0.621||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 570 patients in lixisenatide arm and 285 in placebo arm would provide a power of 99% (or 98%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.621|-0.867|<0.0001
74062129|NCT05016765|147676597|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|paired t-test||||||<0.001
74062130|NCT05016765|147676597|OTHER|Pearson correlation test|Pearson's R|0.21||||0.33|TWO_SIDED|95.0|-0.22|0.56|||Regression, Linear|Pearson's R||Correlation of this Outcome measure (change in tic frequency with stimulation during this study) with the change in tic frequency (measured as the number of 10-second tic-free intervals) during active, rhythmic stimulation in the randomized, controlled trial of MNS that all participants had previously completed.||0.56|-0.22|0.33
74062131|NCT05016765|147676598|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Paired Samples Wilcoxon Test||||||<0.001
74062132|NCT05016765|147676598|OTHER|Pearson's R|Pearson's R|0.36||||0.08|TWO_SIDED|95.0|-0.05|0.66|||Regression, Linear|Pearson's R||Correlation of this Outcome measure (change in tic intensity during this study) with change in tic intensity during active, rhythmic stimulation during the randomized, controlled trial that all participants had previously completed.||0.66|-0.05|0.08
74062133|NCT05016765|147676603|OTHER|Traditional comparative||||||0.84|||||||Paired Sample t-Test, 2-Sided|||||||0.84
74062134|NCT04101721|147676610|NON_INFERIORITY|Non-inferiority margin is 5%|Adjusted difference|1.81|||||TWO_SIDED|95.1|-15.71|19.33||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status.||19.33|-15.71|
74062135|NCT04101721|147676611|SUPERIORITY||Adjusted difference|-3.66|||||TWO_SIDED|95.1|-19.86|12.54||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status.||12.54|-19.86|
74062136|NCT04101721|147676612|SUPERIORITY||Adjusted difference|10.1|||||TWO_SIDED|95.1|-9.83|30.02||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status||30.02|-9.83|
74062137|NCT02494583|147676617|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.03918|TWO_SIDED|95.0|0.7|1.02||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the SOC arm to address the first primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.||1.02|0.70|0.03918
74062138|NCT02494583|147676618|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.04611|TWO_SIDED|95.0|0.7|1.03||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the SOC arm to address the second primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.03|0.70|0.04611
74062139|NCT02494583|147676619|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.15804|TWO_SIDED|95.0|0.62|1.17||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro combo arm was compared to OS in CPS ≥10 participants of the SOC arm to address the third primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.17|0.62|0.15804
74062140|NCT02494583|147676620|NON_INFERIORITY|Pre-specified non-inferiority margin: if the upper bound of the confidence interval (based on the alpha level allocated to the analysis) for the hazard ratio (\[HR\], pembro mono arm vs SOC) is \< 1.2, the pembro mono arm could be considered as non-inferior to the SOC arm in terms of OS.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|99.2|0.69|1.18|||||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fourth primary hypothesis (non-inferiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.18|0.69|
74062141|NCT02494583|147676620|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.16205|TWO_SIDED|95.0|0.74|1.1||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fifth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.10|0.74|0.16205
74062142|NCT02494583|147676621|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.01491|TWO_SIDED|95.0|0.49|0.97||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro mono arm was compared to OS in CPS ≥10 participants of the SOC arm to address the sixth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||0.97|0.49|0.01491
74062143|NCT02494583|147676622|OTHER||Difference in ORR Percentage|11.5||||0.00447|TWO_SIDED|95.0|2.9|20.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.||20.0|2.9|0.00447
74062144|NCT02494583|147676624|OTHER||Difference in ORR Percentage|-22.3|||>|0.99999|TWO_SIDED|95.0|-29.6|-14.9||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.||-14.9|-29.6|>0.99999
74062145|NCT02494583|147676626|OTHER||Hazard Ratio (HR)|1.64||||1|TWO_SIDED|95.0|1.36|1.98||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.||1.98|1.36|1.00000
74062146|NCT02494583|147676627|OTHER||Difference in LS Means|-0.16||||0.948|TWO_SIDED|95.0|-5.01|4.69||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Stratified analyses could be based on collapsing strata with insufficient number of participants or events; strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||4.69|-5.01|0.948
74062147|NCT02494583|147676628|OTHER||Difference in LS Means|1.98||||0.368|TWO_SIDED|95.0|-2.34|6.31||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||6.31|-2.34|0.368
73888252|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.73|||<|0.0001|TWO_SIDED|95.0|-13.53|-9.93|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.93|-13.53|<0.0001
73882435|NCT00286442|147298789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191||||0.177|TWO_SIDED|95.0|-0.086|0.468||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.468|-0.086|0.177
73882436|NCT00286442|147298790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.394||||0.007|TWO_SIDED|95.0|0.107|0.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.680|0.107|0.007
73882437|NCT00286442|147298790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263||||0.074|TWO_SIDED|95.0|-0.025|0.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.550|-0.025|0.074
73882438|NCT00286442|147298791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.15|||<|0.001|TWO_SIDED|95.0|2.117|17.864||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||17.864|2.117|<0.001
73882439|NCT00286442|147298791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.322||||0.002|TWO_SIDED|95.0|1.82|15.564||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||15.564|1.820|0.002
73882440|NCT00286442|147298792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.092|||<|0.001|TWO_SIDED|95.0|3.271|11.345||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||11.345|3.271|<0.001
73882441|NCT00286442|147298792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.451|||<|0.001|TWO_SIDED|95.0|2.388|8.296||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||8.296|2.388|<0.001
73882442|NCT00286442|147298793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.238|||<|0.001|TWO_SIDED|95.0|2.327|7.717||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||7.717|2.327|<0.001
73882443|NCT00286442|147298793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.293|||<|0.001|TWO_SIDED|95.0|1.814|5.979|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||5.979|1.814|<0.001
73882444|NCT00286442|147298794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.103|||<|0.001|TWO_SIDED|95.0|2.428|6.934||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||6.934|2.428|<0.001
73888253|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.71|||<|0.0001|TWO_SIDED|95.0|-17.51|-13.91|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-13.91|-17.51|<0.0001
73882445|NCT00286442|147298794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.314|||<|0.001|TWO_SIDED|95.0|2.545|7.312||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||7.312|2.545|<0.001
73882446|NCT00286442|147298795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.601|||<|0.001|TWO_SIDED|95.0|2.554|12.282||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||12.282|2.554|<0.001
74062148|NCT02494583|147676629|OTHER||Difference in LS Means|2.35||||0.308|TWO_SIDED|95.0|-2.18|6.89||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||6.89|-2.18|0.308
74062149|NCT02494583|147676630|OTHER||Difference in LS Means|-6.56||||0.001|TWO_SIDED|95.0|-10.55|-2.58||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||-2.58|-10.55|0.001
74062150|NCT00865306|147676678|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<.05
74062151|NCT00865306|147676679|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<.01
74062152|NCT02058368|147676682|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.069|TWO_SIDED|95.0|-0.06|1.65||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 3.|||1.65|-0.06|0.069
73888254|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.88|||<|0.0001|TWO_SIDED|95.0|-10.67|-7.09|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-7.09|-10.67|<0.0001
73882447|NCT00286442|147298795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.793|||<|0.001|TWO_SIDED|95.0|2.645|12.684||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||12.684|2.645|<0.001
73882448|NCT00286442|147298796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.449||||0.085|TWO_SIDED|95.0|0.883|6.797||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||6.797|0.883|0.085
73882449|NCT00286442|147298796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.958||||0.034|TWO_SIDED|95.0|1.087|8.046||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||8.046|1.087|0.034
73882450|NCT00286442|147298797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.404||||0.639|TWO_SIDED|95.0|0.34|5.803||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||5.803|0.340|0.639
73882451|NCT00286442|147298797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.959||||0.956|TWO_SIDED|95.0|0.218|4.223||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||4.223|0.218|0.956
74062153|NCT02058368|147676682|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.43|TWO_SIDED|95.0|-0.55|1.29||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 6.|||1.29|-0.55|0.43
74062154|NCT02058368|147676682|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.76|TWO_SIDED|95.0|-1.05|0.77||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 9.|||0.77|-1.05|0.76
74062155|NCT02058368|147676682|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.41|TWO_SIDED|95.0|-1.27|0.53||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 12.|||0.53|-1.27|0.41
73882452|NCT00286442|147298798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.439|TWO_SIDED|95.0|-0.63|0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.27|-0.63|0.439
74062156|NCT02058368|147676682|SUPERIORITY||Mean Difference (Final Values)|-0.95||||0.039|TWO_SIDED|95.0|-1.85|-0.05||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 15.|||-0.05|-1.85|0.039
74062157|NCT02058368|147676682|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.15|TWO_SIDED|95.0|-1.65|0.26||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 18.|||0.26|-1.65|0.15
74062158|NCT02058368|147676682|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.15|TWO_SIDED|95.0|-1.68|0.25||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 21.|||0.25|-1.68|0.15
73882453|NCT00286442|147298798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.075|TWO_SIDED|95.0|-0.86|0.04||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.04|-0.86|0.075
73882454|NCT00286442|147298799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.305|TWO_SIDED|95.0|-0.26|0.83||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.83|-0.26|0.305
73882455|NCT00286442|147298799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.788|TWO_SIDED|95.0|-0.63|0.47||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.47|-0.63|0.788
73882456|NCT00286442|147298800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.93|TWO_SIDED|95.0|-0.58|0.63||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.63|-0.58|0.930
73882457|NCT00286442|147298800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.559|TWO_SIDED|95.0|-0.79|0.43||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.43|-0.79|0.559
74062159|NCT02058368|147676682|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.004|TWO_SIDED|95.0|-2.4|-0.46||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 24.|||-0.46|-2.40|0.004
74062160|NCT02058368|147676683|SUPERIORITY||Mean Difference (Final Values)|-23.0|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-25.9|-20.1||Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 12.|||-20.1|-25.9|<.001
74062161|NCT02058368|147676683|SUPERIORITY|Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|Mean Difference (Final Values)|-28.4|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|-31.7|-25.2|||General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 24|||-25.2|-31.7|<.001
74062162|NCT02058368|147676684|SUPERIORITY|||||||0.91||||||P-value for IPSS improvement \>= 3 units has been presented for Month 3|Mantel Haenszel|||||||0.91
74062163|NCT02058368|147676684|SUPERIORITY|||||||0.31||||||P-value for IPSS improvement \>= 2 units has been presented for Month 3|Mantel Haenszel|||||||0.31
74062164|NCT02058368|147676684|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 3|Mantel Haenszel|||||||0.42
74062165|NCT02058368|147676684|SUPERIORITY|||||||0.92||||||P-value for IPSS improvement \>= 3 units has been presented for Month 6|Mantel Haenszel|||||||0.92
74062166|NCT02058368|147676684|SUPERIORITY|||||||0.89||||||P-value for IPSS improvement \>= 2 units has been presented for Month 6|Mantel Haenszel|||||||0.89
74062167|NCT02058368|147676684|SUPERIORITY|||||||0.81||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 6|Mantel Haenszel|||||||0.81
73882458|NCT00286442|147298801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-0.66|0.66||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.66|-0.66|0.996
73882459|NCT00286442|147298801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.407|TWO_SIDED|95.0|-0.94|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.38|-0.94|0.407
73882460|NCT04571944|147298804|SUPERIORITY||Difference in % vs Placebo|-8.7||||0.129|TWO_SIDED|95.0|-20.1|2.6|||Miettinen and Nurminen method|Analysis was stratified by hospitalization reason (acute disease, elective surgery) and age category (\<75 years, ≥75 years).||||2.6|-20.1|0.129
73882461|NCT04571944|147298805|OTHER||Difference in % vs. Placebo|0.8|||||TWO_SIDED|95.0|-9.3|11.0||||||||11.0|-9.3|
73882462|NCT04571944|147298806|OTHER||Difference in % vs. Placebo|0.0|||||TWO_SIDED|95.0|-5.1|5.2||||||||5.2|-5.1|
73882463|NCT04571944|147298807|SUPERIORITY||Difference vs. Placebo|-0.5||||0.485|TWO_SIDED|95.0|-2.0|1.0||Based on aligned rank test.|Hodges-Lehmann method|||||1.0|-2.0|0.485
73882464|NCT04571944|147298808|SUPERIORITY||Difference in % vs. Placebo|-8.6||||0.136|TWO_SIDED|95.0|-20.2|2.8|||Miettinen and Nurminen method|Analysis was stratified by hospitalization reason (acute disease, elective surgery) and age category (\<75 years, ≥75 years).||||2.8|-20.2|0.136
73882465|NCT00321789|147298886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.44|TWO_SIDED|95.0|-3.6|8.3|||Mixed Models Analysis|Model was adjusted for a priori race and cardiovascular disease risk level strata.||||8.3|-3.6|0.44
73882466|NCT00321789|147298887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.03|TWO_SIDED|95.0|-0.23|-0.01|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.01|-0.23|0.03
73882467|NCT00321789|147298888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.02|TWO_SIDED|95.0|-0.29|-0.02|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.02|-0.29|0.02
73882468|NCT00321789|147298889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.02|TWO_SIDED|95.0|-0.29|-0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.03|-0.29|0.02
73882469|NCT00321789|147298890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.11|TWO_SIDED|95.0|-0.3|0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||0.03|-0.30|0.11
73882470|NCT00321789|147298891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.26|TWO_SIDED|95.0|-0.06|0.2|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||0.20|-0.06|0.26
73882471|NCT00321789|147298892|SUPERIORITY_OR_OTHER||incident rate ratio|1.2||||0.06|TWO_SIDED|95.0|1.0|1.5|||generalized estimating equations|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||1.5|1.0|0.06
73882472|NCT00321789|147298893|SUPERIORITY_OR_OTHER||incident rate ratio|1.1||||0.37|TWO_SIDED|95.0|0.9|1.4|||generalized estimating equations|Model adjusted for a priori race and cardiovascular disease risk category.||||1.4|0.9|0.37
73882473|NCT00321789|147298894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.11||||0.04|TWO_SIDED|95.0|-4.13|-0.09|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.||||-0.09|-4.13|0.04
74062168|NCT02058368|147676684|SUPERIORITY|||||||0.08||||||P-value for IPSS improvement \>= 3 units has been presented for Month 9|Mantel Haenszel|||||||0.080
74062169|NCT02058368|147676684|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 2 units has been presented for Month 9|Mantel Haenszel|||||||0.42
74062170|NCT02058368|147676684|SUPERIORITY|||||||0.06||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 9|Mantel Haenszel|||||||0.060
74062171|NCT02058368|147676684|SUPERIORITY|||||||0.14||||||P-value for IPSS improvement \>= 3 units has been presented for Month 12|Mantel Haenszel|||||||0.14
74062172|NCT02058368|147676684|SUPERIORITY|||||||0.26||||||P-value for IPSS improvement \>= 2 units has been presented for Month 12|Mantel Haenszel|||||||0.26
74062173|NCT02058368|147676684|SUPERIORITY|||||||0.048||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 12|Mantel Haenszel|||||||0.048
74062174|NCT02058368|147676684|SUPERIORITY|||||||0.17||||||P-value for IPSS improvement \>= 3 units has been presented for Month 15|Mantel Haenszel|||||||0.17
73882474|NCT00321789|147298895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.09|TWO_SIDED|95.0|-1.38|0.1|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.||||0.10|-1.38|0.09
73882475|NCT00321789|147298896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.87|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|Model adjusted for a priori race and cardiovascular disease risk category.||||1.7|0.6|0.87
74062175|NCT02058368|147676684|SUPERIORITY|||||||0.11||||||P-value for IPSS improvement \>= 2 units has been presented for Month 15|Mantel Haenszel|||||||0.11
74062176|NCT02058368|147676684|SUPERIORITY|||||||0.022||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 15|Mantel Haenszel|||||||0.022
74062177|NCT02058368|147676684|SUPERIORITY|||||||0.18||||||P-value for IPSS improvement \>= 3 units has been presented for Month 18|Mantel Haenszel|||||||0.18
74062178|NCT02058368|147676684|SUPERIORITY|||||||0.19||||||P-value for IPSS improvement \>= 2 units has been presented for Month 18|Mantel Haenszel|||||||0.19
74062179|NCT02058368|147676684|SUPERIORITY|||||||0.28||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 18|Mantel Haenszel|||||||0.28
74062180|NCT02058368|147676684|SUPERIORITY|||||||0.39||||||P-value for IPSS improvement \>= 3 units has been presented for Month 21|Mantel Haenszel|||||||0.39
74062181|NCT02058368|147676684|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 2 units has been presented for Month 21|Mantel Haenszel|||||||0.42
74062182|NCT02058368|147676684|SUPERIORITY|||||||0.084||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 21|Mantel Haenszel|||||||0.084
74062183|NCT02058368|147676684|SUPERIORITY|||||||0.016||||||P-value for IPSS improvement \>= 3 units has been presented for Month 24|Mantel Haenszel|||||||0.016
74062184|NCT02058368|147676684|SUPERIORITY|||||||0.047||||||P-value for IPSS improvement \>= 2 units has been presented for Month 24|Mantel Haenszel|||||||0.047
74062185|NCT02058368|147676684|SUPERIORITY|||||||0.007||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 24|Mantel Haenszel|||||||0.007
74062186|NCT02058368|147676685|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.33||0.006|TWO_SIDED|95.0|0.26|1.56||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||1.56|0.26|0.006
74062187|NCT02058368|147676685|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.35||0.005|TWO_SIDED|95.0|0.3|1.69||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||1.69|0.30|0.005
74062188|NCT02058368|147676685|SUPERIORITY||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|0.63|2.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||2.29|0.63|<.001
74062189|NCT02058368|147676685|SUPERIORITY||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|95.0|0.54|2.15||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||2.15|0.54|0.001
74062190|NCT02058368|147676686|SUPERIORITY|||||||0.13||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 6|Mantel Haenszel|||||||0.13
73882476|NCT00534365|147298898|NON_INFERIORITY_OR_EQUIVALENCE|We chose a non-inferiority margin of 12% based on previously published multicenter trial of mid-urethral slings. Assuming subjective cure rate for TVT of 82%, 127 individuals in each group will provide 80% to reject the null hypothesis that the true difference in cure rates between the two procedures is less than or equal to 2% using a two group large sample normal approximation test of proportions with a one sided 0.05 significance level.||||||0.43|||||||Regression, Logistic|||||||0.43
73882477|NCT00534365|147298901|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
73882478|NCT00534365|147298902|SUPERIORITY_OR_OTHER|||||||0.015|||||||t-test, 2 sided|||||||0.015
73882479|NCT03309020|147298904|OTHER|||||||0.802||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||Null hypothesis is no difference in grade between survivor statuses one month after cataract surgery||||0.802
73882480|NCT03309020|147298905|OTHER|||||||0.713||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||Null hypothesis is no difference in grade between survivor statuses three months after cataract surgery||||.713
74062191|NCT02058368|147676686|SUPERIORITY|||||||0.15||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 6|Mantel Haenszel|||||||0.15
74062192|NCT02058368|147676686|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 12|Mantel Haenszel|||||||<.001
74062193|NCT02058368|147676686|SUPERIORITY|||||||0.003||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 12|Mantel Haenszel|||||||0.003
74062194|NCT02058368|147676686|SUPERIORITY|||||||0.002||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 18|Mantel Haenszel|||||||0.002
74062195|NCT02058368|147676686|SUPERIORITY|||||||0.009||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 18|Mantel Haenszel|||||||0.009
74062196|NCT02058368|147676686|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 24|Mantel Haenszel|||||||<.001
74062197|NCT02058368|147676686|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 24|Mantel Haenszel|||||||<.001
74062198|NCT02058368|147676687|SUPERIORITY||Cox Proportional Hazard|0.27||||0.012|TWO_SIDED|95.0|0.09|0.81||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||0.81|0.09|0.012
74062199|NCT02058368|147676688|SUPERIORITY||Cox Proportional Hazard|0.15||||0.005|TWO_SIDED|95.0|0.03|0.68||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||0.68|0.03|0.005
74062200|NCT02058368|147676689|SUPERIORITY||Cox Proportional Hazard|0.69||||0.68|TWO_SIDED|95.0|0.11|4.11||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||4.11|0.11|0.68
74062201|NCT02058368|147676690|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.1||0.83|TWO_SIDED|95.0|-0.17|0.21||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 3|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.21|-0.17|0.83
74062202|NCT02058368|147676690|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|-0.04|0.36||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.36|-0.04|0.11
74062203|NCT02058368|147676690|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.21|TWO_SIDED|95.0|-0.07|0.34||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 9|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.34|-0.07|0.21
74062204|NCT02058368|147676690|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.1||0.8|TWO_SIDED|95.0|-0.23|0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.18|-0.23|0.80
74062205|NCT02058368|147676690|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.37|TWO_SIDED|95.0|-0.3|0.11||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 15|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.11|-0.30|0.37
74062206|NCT02058368|147676690|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11||0.44|TWO_SIDED|95.0|-0.3|0.13||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.13|-0.30|0.44
74062207|NCT02058368|147676690|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.6|TWO_SIDED|95.0|-0.16|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 21|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.28|-0.16|0.60
74062208|NCT02058368|147676690|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.16|TWO_SIDED|95.0|-0.37|0.06||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.06|-0.37|0.16
74062209|NCT02058368|147676691|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.18||0.17|TWO_SIDED|95.0|-0.11|0.62||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 3|||0.62|-0.11|0.17
74062210|NCT02058368|147676691|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.2|0.59||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 6|||0.59|-0.20|0.33
74062211|NCT02058368|147676691|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.2||0.15|TWO_SIDED|95.0|-0.1|0.68||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 9|||0.68|-0.10|0.15
74062212|NCT02058368|147676691|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.21||0.46|TWO_SIDED|95.0|-0.25|0.55||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 12|||0.55|-0.25|0.46
74062213|NCT02058368|147676691|SUPERIORITY||Median Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.59|TWO_SIDED|95.0|-0.51|0.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 15|||0.29|-0.51|0.59
74062214|NCT02058368|147676691|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.56|TWO_SIDED|95.0|-0.52|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 18|||0.28|-0.52|0.56
74062215|NCT02058368|147676691|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.21||0.51|TWO_SIDED|95.0|-0.56|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 21|||0.28|-0.56|0.51
74062216|NCT02058368|147676691|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.21||0.034|TWO_SIDED|95.0|-0.88|-0.03||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 24|||-0.03|-0.88|0.034
74062217|NCT02058368|147676692|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.54|-0.5||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value.P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-0.50|-1.54|<.001
73882481|NCT03309020|147298906|OTHER||Odds Ratio (OR)|0.1|||||TWO_SIDED|95.0|0.01|0.69|||||Odds of eye with at least 20/40 best corrected visual acuity (BCVA) 12 months after cataract surgery for controls vs. EVD survivors|Null hypothesis is no difference in the proportion of participants with at least 20/40 best corrected visual acuity (BCVA) between survivor statuses||0.69|0.01|
73882482|NCT03309020|147298907|OTHER|||||||0.832||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||.832
73882483|NCT03309020|147298908|OTHER|||||||0.995||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||.995
74062218|NCT02058368|147676692|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.27||0.009|TWO_SIDED|95.0|-1.23|-0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-0.18|-1.23|0.009
74062219|NCT02058368|147676697|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-2.1|-1.6||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-1.6|-2.1|<.001
74062220|NCT02058368|147676697|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-2.3|-1.9||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-1.9|-2.3|<.001
74062221|NCT02058368|147676697|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-3.1|-2.2||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-2.2|-3.1|<.001
74062222|NCT02058368|147676699|SUPERIORITY|||||||0.77||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 6|Van Elteren test|||||||0.77
73882484|NCT03309020|147298909|OTHER|||||||0.441||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||0.441
73882485|NCT03309020|147298910|OTHER|||||||0.892||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent||||||.892
73882486|NCT03309020|147298911|OTHER|||||||0.913||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent||||||.913
73882487|NCT03309020|147298912|OTHER|||||||0.106||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent||||||.106
73882488|NCT03309020|147298913|OTHER|||||||0.09||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent||||||0.09
73882489|NCT00402168|147298923|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|95.0|2.1|14.9||||||At Month 6, difference in percentage of participants with acute rejection (number with acute rejection/number randomized) using exact method.||14.9|2.1|
73882490|NCT00402168|147298923|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|95.0|2.1|14.9||||||At Month 12, difference in percentage of participants with acute rejection using exact method.||14.9|2.1|
73882491|NCT00402168|147298924|SUPERIORITY_OR_OTHER||Percent Difference|1.1|||||TWO_SIDED|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 6: For 95% Confidence Interval (CI) of difference, exact method was used.||6.1|-3.3|
73882492|NCT00402168|147298924|SUPERIORITY_OR_OTHER||Percent Difference|1.1|||||TWO_SIDED|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 12: For 95% CI of difference, exact method was used.||6.1|-3.3|
74062223|NCT02058368|147676699|SUPERIORITY|||||||0.84||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 12|Van Elteren test|||||||0.84
73882493|NCT00402168|147298927|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-0.1|13.8||||||||13.8|-0.1|
74062224|NCT02058368|147676699|SUPERIORITY|||||||0.98||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 18|Van Elteren test|||||||0.98
74062225|NCT02058368|147676699|SUPERIORITY|||||||0.28||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 24|Van Elteren test|||||||0.28
74062226|NCT01652872|147676719|OTHER||Treatment Difference|-0.27|||||TWO_SIDED|95.0|-6.39|5.85|||||Difference is fixed dose - titration.|||5.85|-6.39|
74062227|NCT01652872|147676719|OTHER||Risk Ratio (RR)|0.998|||||TWO_SIDED|95.0|0.776|1.285|||Cochran-Mantel-Haenszel|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).|A risk ratio \< 1.0 indicates a lower event rate for the fixed dose group relative to Hb-based titration group.|||1.285|0.776|
74062228|NCT01652872|147676720|OTHER|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology) and accounting for participant exposure time.|Least Squares Mean (LSM) Ratio|1.28|||||TWO_SIDED|95.0|0.81|2.05|||Negative binomial regression model||Least Squares Mean (LSM) ratio is fixed dose relative to titration.|||2.05|0.81|
74062229|NCT01652872|147676721|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.76|1.35|||Cox Proportional Hazard Model|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).|Hazard ratio is fixed dose relative to titration.|||1.35|0.76|
74062230|NCT01652872|147676722|OTHER||Median of the difference|-0.34|||||TWO_SIDED|95.0|-0.46|-0.22|||Hodges-Lehmann estimate||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.|-0.22|-0.46|
74062231|NCT01652872|147676723|OTHER||Median of the difference|-22.1|||||TWO_SIDED|95.0|-26.1|-18.1|||Hodges-Lehmann estimate||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.|-18.1|-26.1|
73882494|NCT00402168|147298932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1||||0.4491|TWO_SIDED|95.0|-1.7|3.9|||ANCOVA|||Mental Component Scales (MCS)||3.9|-1.7|0.4491
73882495|NCT00402168|147298932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7892|TWO_SIDED|95.0|-2.5|1.9|||ANCOVA|||Physical Component Scales (PCS)||1.9|-2.5|0.7892
73882496|NCT00402168|147298934|SUPERIORITY_OR_OTHER||Estimated Difference|0.0076|||||TWO_SIDED|95.0|-0.01|0.0252||||||Difference in Symptom Occurrence between treatment groups.||.0252|-.010|
73882497|NCT00402168|147298934|SUPERIORITY_OR_OTHER||Estimated Difference|0.0148|||||TWO_SIDED|95.0|-0.002|0.0321||||||Difference in Symptom Distress between treatment groups.||.0321|-.002|
74062232|NCT02499406|147676731|SUPERIORITY||||||>|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.||||>0.016
74062233|NCT02499406|147676732|SUPERIORITY||||||<|0.016||||||p value was calculated and found to be below the a priori threshold for significance, which was adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.||||<0.016
74062234|NCT02499406|147676733|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.||||<0.016
74062235|NCT02499406|147676734|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=14||Null hypothesis is that there is no difference in paired samples between baseline and 3-month assessment||||<0.016
74062236|NCT02499406|147676735|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=10||Null hypothesis is no difference between baseline and this 6-month assessment.||||<0.016
74062237|NCT02499406|147676736|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=11||Null hypothesis is no difference between baseline and this 9-month assessment.||||<0.016
74062238|NCT02499406|147676737|SUPERIORITY||||||>|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.||||> 0.016
74062239|NCT02499406|147676738|SUPERIORITY||||||=|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=10||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.||||=.016
74062240|NCT02499406|147676739|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.||||<0.016
74062241|NCT01818414|147676769|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
74062242|NCT01818414|147676770|SUPERIORITY_OR_OTHER|||||||0.052|||||||t-test, 2 sided|||||||0.052
74062243|NCT01227954|147676775|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||To detect a minimum relative 50% improvement leading to an absolute 15% mean relative decline (MRD) in HVLT-R DR, 51 analyzable patients were required to ensure 80% statistical power with 0.05 alpha. Assuming a death rate of 40% before 4 months (based on trial NCT00003563) and a 10% nonevaluable rate, the target sample size was 102. The target MRD was determined from NCT00003563 which demonstrated 30% MRD in HVLT-R DR score from baseline to 4 months, with a standard deviation of 41%.||||<0.001
74062244|NCT01227954|147676778|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and recursive partitioning analysis class (RPA) (I vs. II). Explanatory variables are reported separately and only if in the final model (p\< 0.10, except time forced in the model.). Intercept is reported here.||||<0.0001
74062245|NCT01227954|147676778|SUPERIORITY|||||||0.1961|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Time is reported here.||||0.1961
74062246|NCT01227954|147676778|SUPERIORITY|||||||0.0715|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Primary site (lung) is reported here.||||0.0715
74062247|NCT01227954|147676778|SUPERIORITY|||||||0.0554|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Neurologic status (no symptoms) is reported here.||||0.0554
74062248|NCT01227954|147676779|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Intercept is reported here.||||<0.0001
74062249|NCT01227954|147676779|SUPERIORITY|||||||0.1579|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Time is reported here.||||0.1579
74062250|NCT01227954|147676779|SUPERIORITY|||||||0.0559|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Neurologic function status (some symptoms) is reported here.||||0.0559
74062251|NCT01227954|147676779|SUPERIORITY|||||||0.0749|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Age (\>= 60) is reported here.||||0.0749
74062252|NCT02209272|147676815|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
74062253|NCT02209272|147676816|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
74062254|NCT02209272|147676817|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
74062255|NCT02787785|147676818|SUPERIORITY||Cox Proportional Hazard|0.49||||0.354|TWO_SIDED|95.0|0.11|2.2|||Regression, Cox|||||2.20|0.11|0.354
73882498|NCT03137992|147298977|EQUIVALENCE|Bioequivalence was declared if the 90% CI was entirely contained within the bioequivalence interval, 0.80 to 1.25.|Least Squared Mean Ratio|0.9369|||||TWO_SIDED|90.0|0.834|1.047|||||Fieller's formula was applied to calculate the 90% confidence interval (CI) for the Lupin Tiotropium and Spiriva Handihaler LS mean ratio.|A blinded interim analysis was performed after 241 subjects had been randomized with measurable AUC data, which estimated 238 patients would be needed to demonstrate BE with 90% power. Therefore, it was planned that approximately 378 patients would be randomized to allow for a potential 30% loss/withdrawal from the PP population.||1.047|0.834|
74062256|NCT02787785|147676820|SUPERIORITY||Cox Proportional Hazard|0.37||||0.479|TWO_SIDED|95.0|0.02|5.88|||Regression, Cox|||||5.88|0.02|0.479
74062257|NCT00663039|147676843|SUPERIORITY|||||||0.758|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Affect Scores between Oxytocin and Placebo Arms||||0.758
74062258|NCT00663039|147676843|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Social Skill scores between Oxytocin and Placebo arms||||0.779
74062259|NCT00663039|147676844|SUPERIORITY|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 1 scores between Oxytocin and Placebo Arms||||0.578
74062260|NCT00663039|147676844|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 2 scores between Oxytocin and Placebo Arms||||0.28
74062261|NCT00663039|147676844|SUPERIORITY|||||||0.707|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 3 scores between Oxytocin and Placebo Arms||||0.707
74062262|NCT00663039|147676845|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total amount of money offered during the trust game between the Oxytocin and Placebo arms||||0.391
74062263|NCT00663039|147676846|SUPERIORITY|||||||0.559|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Reaction Time between Oxytocin and Placebo arms.||||0.559
74062264|NCT00663039|147676846|SUPERIORITY|||||||0.858|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Reaction Time between Oxytocin and Placebo arms.||||0.858
74062265|NCT00663039|147676846|SUPERIORITY|||||||0.514|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms Reaction Time between Oxytocin and Placebo arms||||0.514
74062266|NCT00663039|147676846|SUPERIORITY|||||||0.088|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms Reaction Time between Oxytocin and Placebo arms||||0.088
74062267|NCT00663039|147676847|SUPERIORITY|||||||0.296|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Hits between Oxytocin and Placebo arms.||||0.296
74062268|NCT00663039|147676847|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.||||0.136
74062269|NCT00663039|147676847|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms between Oxytocin and Placebo arms.||||0.47
74062270|NCT00663039|147676847|SUPERIORITY|||||||0.702|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.||||0.702
73882499|NCT03137992|147298978|SUPERIORITY||Least Squared Mean Difference|3.29|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|2.9386|3.646||Efficacy of the Test (T) product was demonstrated if the T was shown to be statistically superior to Placebo (p\<0.05 \[two-tailed\]).Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.|Mixed Models Analysis|Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.||||3.646|2.9386|<0.001
73882500|NCT03137992|147298978|SUPERIORITY||Least Squared Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|3.0718|3.7797||Study sensitivity was demonstrated if the Reference (R) product was shown to be statistically superior to Placebo (P) (p \<0.05 \[two-tailed\]). Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.|Mixed Models Analysis|Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.||||3.7797|3.0718|<0.001
74062271|NCT00663039|147676848|SUPERIORITY|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||Comparison of Brief Assessments of Cognition for Schizophrenia scores between the Oxytocin and Placebo arms.||||0.451
74062272|NCT00663039|147676849|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.9
74062273|NCT00663039|147676850|SUPERIORITY|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||Comparison of Reading the Mind in the Eyes total scores between Oxytocin and Placebo arms||||0.946
74062274|NCT00663039|147676851|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Total scores between Oxytocin and Placebo arms||||0.016
74062275|NCT00663039|147676851|SUPERIORITY|||||||0.185|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Hits between Oxytocin and Placebo arms||||0.185
73882501|NCT00795704|147298993|SUPERIORITY_OR_OTHER|||||||0.079|||||||t-test, 2 sided|||||||0.079
73882502|NCT00795704|147298995|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73882503|NCT03980730|147298996|SUPERIORITY|||||||0.2057|||||||Mixed Models Analysis|||||||0.2057
73882504|NCT02392806|147299007|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73882505|NCT03125226|147299011|OTHER|Single group mean and standard deviation||||||||||||||||Coordinates in x/y/z planes were assigned to each hydrogel marker on the planning CT and daily CBCT to calculate interfraction motion.|Single group mean and standard deviation|||
73882506|NCT03125226|147299016|OTHER|The Van Herk (VH) margin equation for the planning target volume margin, as a function of systemic and random errors, was calculated such that the CTV receives at least 95%-prescription dose in 90% of patients.|||||||||||||||||The Van Herk (VH) margin equation for the planning target volume margin, as a function of systemic and random errors, was calculated such that the CTV receives at least 95%-prescription dose in 90% of patients.|||
73882507|NCT00301808|147299017|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier product limit|0.66|STANDARD_ERROR_OF_MEAN|0.1423|||TWO_SIDED|95.0|0.48|0.84||||||||0.84|0.48|
74062276|NCT00663039|147676851|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition False Alarms between Oxytocin and Placebo arms||||0.404
74062277|NCT00038467|147676873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||3e-05|TWO_SIDED|95.0|0.58|0.82|||Log Rank|||||0.82|0.58|0.00003
73882508|NCT02099864|147299033|OTHER||Odds Ratio (OR)|10.0||||0.055|TWO_SIDED|95.0|0.9|108.8|||Fisher Exact|Due to sample size, Fisher's exact test was used rather than simple logistic regression.||||108.8|0.9|0.055
74062278|NCT00038467|147676874|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.913||||0.15737|TWO_SIDED|95.0|0.806|1.036|||Log Rank|||||1.036|0.806|0.15737
74062279|NCT00038467|147676876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|||<|0.0001|TWO_SIDED|95.0|1.63|3.23|||t-test, 2 sided|||6 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||3.23|1.63|<0.0001
74062280|NCT00038467|147676876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18||||0.0002|TWO_SIDED|95.0|0.57|1.79|||t-test, 2 sided|||6 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||1.79|0.57|0.0002
74062281|NCT00038467|147676876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.79|||<|0.0001|TWO_SIDED|95.0|1.77|3.81|||t-test, 2 sided|||12 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||3.81|1.77|<0.0001
74062282|NCT00038467|147676876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|||<|0.0001|TWO_SIDED|95.0|1.12|2.46|||t-test, 2 sided|||12 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||2.46|1.12|<0.0001
74062283|NCT00038467|147676876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|||<|0.0001|TWO_SIDED|95.0|2.1|4.35|||t-test, 2 sided|||24 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||4.35|2.10|<0.0001
74062284|NCT00038467|147676876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.0001|TWO_SIDED|95.0|1.1|2.69|||t-test, 2 sided|||24 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||2.69|1.10|<0.0001
74062285|NCT00038467|147676885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.5|TWO_SIDED|95.0|-1.76|0.86|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.86|-1.76|0.500
74062286|NCT00038467|147676885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.009|TWO_SIDED|95.0|-3.67|-0.52|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.52|-3.67|0.009
74062287|NCT00038467|147676885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.079|TWO_SIDED|95.0|-2.86|0.16|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.16|-2.86|0.079
74062288|NCT00038467|147676885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.729|TWO_SIDED|95.0|-1.24|1.77|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||1.77|-1.24|0.729
74062289|NCT00038467|147676885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.302|TWO_SIDED|95.0|-2.43|0.75|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.75|-2.43|0.302
74062290|NCT00038467|147676885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.187|TWO_SIDED|95.0|-2.76|0.54|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.54|-2.76|0.187
74062291|NCT00038467|147676886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.26|TWO_SIDED|95.0|-1.8|0.49|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.49|-1.80|0.260
74062292|NCT00038467|147676886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.209|TWO_SIDED|95.0|-2.02|0.44|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.44|-2.02|0.209
74062293|NCT00038467|147676886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.698|TWO_SIDED|95.0|-1.38|0.92|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.92|-1.38|0.698
73882509|NCT02099864|147299034|OTHER||Odds Ratio (OR)|0.7||||1|TWO_SIDED|95.0|0.1|5.3|||Fisher Exact|Due to sample size, Fisher's exact was used rather than regression.||||5.3|0.1|1.000
73882510|NCT02099864|147299035|OTHER||Odds Ratio (OR)|0.7||||1|TWO_SIDED|95.0|0.0|17.0|||Fisher Exact|||||17.0|0.0|1.000
73882511|NCT02099864|147299036|OTHER||Median Difference (Final Values)|23.2||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for responders minus the median for non-responders.|||||0.84
74062294|NCT00038467|147676886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.192|TWO_SIDED|95.0|-0.42|2.09|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||2.09|-0.42|0.192
74062295|NCT00038467|147676886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.813|TWO_SIDED|95.0|-1.46|1.15|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||1.15|-1.46|0.813
74062296|NCT00038467|147676886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.537|TWO_SIDED|95.0|-0.91|1.75|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||1.75|-0.91|0.537
74062297|NCT00038467|147676887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.727|TWO_SIDED|95.0|-3.46|2.42|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||2.42|-3.46|0.727
74062298|NCT00038467|147676887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08||||0.047|TWO_SIDED|95.0|-6.12|-0.05|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.05|-6.12|0.047
73882512|NCT02099864|147299037|OTHER||Median Difference (Final Values)|-1.9||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for responders minus the median for non-responders.|||||0.14
73882513|NCT02099864|147299038|OTHER||Odds Ratio (OR)|2.7||||1|TWO_SIDED|95.0|0.1|60.2|||Fisher Exact|||||60.2|0.1|1.00
73882514|NCT02099864|147299040|OTHER||Median Difference (Final Values)|4.8||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for the responders minus the median for the non-responders.|||||0.01
73882515|NCT02099864|147299043|OTHER||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.45|||Regression, Cox|||||0.45|0.07|<0.001
73882516|NCT02099864|147299044|OTHER||Hazard Ratio (HR)|0.22||||0.002|TWO_SIDED|95.0|0.08|0.56|||Regression, Cox|||||0.56|0.08|0.002
73882517|NCT02099864|147299045|OTHER||Hazard Ratio (HR)|0.23||||0.23|TWO_SIDED|95.0|0.02|0.59|||Regression, Cox|||||0.59|0.02|0.23
73882518|NCT02099864|147299046|OTHER||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.45|||Regression, Cox|||||0.45|0.07|<0.001
73882519|NCT02099864|147299051|OTHER||Hazard Ratio (HR)|4.9|||<|0.001|TWO_SIDED|95.0|2.03|11.82|||Regression, Cox|||||11.82|2.03|<0.001
73882520|NCT05893862|147299052|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|9.22|||<|0.0001|TWO_SIDED|90.0|7.4|11.04|||t-test, 1 sided|||||11.04|7.40|<0.0001
73882521|NCT05893862|147299052|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|8.44||||0.0141|TWO_SIDED|90.0|6.31|10.56|||t-test, 1 sided|||||10.56|6.31|0.0141
73882522|NCT05893862|147299052|OTHER|LS Mean Difference 3 Hr|LS Mean Difference|10.8|||<|0.0001|TWO_SIDED|90.0|8.85|12.74|||t-test, 1 sided|||||12.74|8.85|<0.0001
73882523|NCT05893862|147299052|OTHER|LS Mean Difference Week 4 Hr|LS Mean Difference|6.43||||0.1045|TWO_SIDED|90.0|3.96|8.91|||t-test, 1 sided|||||8.91|3.96|0.1045
73882524|NCT05893862|147299052|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|6.52|||||TWO_SIDED|90.0|4.66|8.38||||||||8.38|4.66|
74062299|NCT00038467|147676887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.553|TWO_SIDED|95.0|-3.88|2.08|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||2.08|-3.88|0.553
74062300|NCT00038467|147676887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.563|TWO_SIDED|95.0|-2.17|3.99|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||3.99|-2.17|0.563
74062301|NCT00038467|147676887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.643|TWO_SIDED|95.0|-3.83|2.36|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||2.36|-3.83|0.643
74062302|NCT00038467|147676887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.91||||0.126|TWO_SIDED|95.0|-6.63|0.82|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.82|-6.63|0.126
74062303|NCT00038467|147676888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.265|TWO_SIDED|95.0|-0.83|0.23|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.23|-0.83|0.265
74062304|NCT00038467|147676888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.0002|TWO_SIDED|95.0|-1.84|-0.57|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.57|-1.84|0.0002
74062305|NCT00038467|147676888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.132|TWO_SIDED|95.0|-1.0|0.13|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.13|-1.00|0.132
74062306|NCT00038467|147676888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.635|TWO_SIDED|95.0|-0.7|0.43|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.43|-0.70|0.635
74062307|NCT00038467|147676888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.449|TWO_SIDED|95.0|-0.75|0.33|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.33|-0.75|0.449
74062308|NCT00038467|147676888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.454|TWO_SIDED|95.0|-0.81|0.36|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.36|-0.81|0.454
74062309|NCT00038467|147676889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.712|TWO_SIDED|95.0|-0.53|0.335|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.335|-0.53|0.712
74062310|NCT00038467|147676889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.899|TWO_SIDED|95.0|-0.65|0.356|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.356|-0.65|0.899
74062311|NCT00038467|147676889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.882|TWO_SIDED|95.0|-0.76|0.359|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.359|-0.76|0.882
74062312|NCT00038467|147676889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.604|TWO_SIDED|95.0|-0.54|0.37|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.37|-0.54|0.604
74062313|NCT00038467|147676889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.562|TWO_SIDED|95.0|-1.16|0.454|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.454|-1.16|0.562
74062314|NCT00038467|147676890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.892|TWO_SIDED|95.0|-0.2|0.18|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.18|-0.20|0.892
74062315|NCT00038467|147676890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.881|TWO_SIDED|95.0|-0.21|0.24|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.24|-0.21|0.881
74062316|NCT00038467|147676890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.883|TWO_SIDED|95.0|-0.18|0.21|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.21|-0.18|0.883
73882525|NCT05893862|147299052|OTHER|LS Mean Difference 11 Hr|LS Mean Difference|7.33||||||90.0|4.74|9.93||||||||9.93|4.74|
73882526|NCT05893862|147299052|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|6.42|||||TWO_SIDED|90.0|3.95|8.88||||||||8.88|3.95|
74062317|NCT00038467|147676890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.604|TWO_SIDED|95.0|-0.16|0.27|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.27|-0.16|0.604
74062318|NCT00038467|147676890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.118|TWO_SIDED|95.0|-0.05|0.41|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.41|-0.05|0.118
74062319|NCT00038467|147676890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.307|TWO_SIDED|95.0|-0.11|0.34|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.34|-0.11|0.307
74062320|NCT00038467|147676891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.792|TWO_SIDED|95.0|-0.42|0.56|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.56|-0.42|0.792
74062321|NCT00038467|147676891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.405|TWO_SIDED|95.0|-0.76|0.31|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.31|-0.76|0.405
74062322|NCT00038467|147676891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.484|TWO_SIDED|95.0|-0.75|0.36|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.36|-0.75|0.484
74062323|NCT00038467|147676891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.229|TWO_SIDED|95.0|-0.19|0.8|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.80|-0.19|0.229
74062324|NCT00038467|147676891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.381|TWO_SIDED|95.0|-0.84|0.32|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.32|-0.84|0.381
74062325|NCT00038467|147676891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.405|TWO_SIDED|95.0|-0.82|0.33|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.33|-0.82|0.405
74062326|NCT00038467|147676892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.648|TWO_SIDED|95.0|-0.77|0.48|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.48|-0.77|0.648
74062327|NCT00038467|147676892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.366|TWO_SIDED|95.0|-1.08|0.4|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.40|-1.08|0.366
74062328|NCT00038467|147676892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.062|TWO_SIDED|95.0|-1.33|0.03|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.03|-1.33|0.062
74062329|NCT00038467|147676892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.545|TWO_SIDED|95.0|-0.53|1.0|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||1.00|-0.53|0.545
74062330|NCT00038467|147676892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.932|TWO_SIDED|95.0|-0.77|0.7|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.70|-0.77|0.932
74062331|NCT00038467|147676892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.244|TWO_SIDED|95.0|-1.24|0.32|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.32|-1.24|0.244
74062332|NCT00038467|147676893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.876|TWO_SIDED|95.0|-0.62|0.73|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.73|-0.62|0.876
74062333|NCT00038467|147676893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.195|TWO_SIDED|95.0|-1.25|0.26|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.26|-1.25|0.195
74062334|NCT00038467|147676893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.63|TWO_SIDED|95.0|-0.92|0.55|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.55|-0.92|0.630
74062335|NCT00038467|147676893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.53|TWO_SIDED|95.0|-0.5|0.98|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.98|-0.50|0.530
74062336|NCT00038467|147676893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.147|TWO_SIDED|95.0|-1.43|0.21|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.21|-1.43|0.147
74062337|NCT00038467|147676893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.389|TWO_SIDED|95.0|-1.18|0.46|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.46|-1.18|0.389
74062338|NCT00038467|147676895|SUPERIORITY_OR_OTHER|||||||0.0174|TWO_SIDED||||||Chi-squared|||6 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0174
74062339|NCT00038467|147676895|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||Chi-squared|||12 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0059
74062340|NCT00038467|147676895|SUPERIORITY_OR_OTHER|||||||0.0037|TWO_SIDED||||||Chi-squared|||24 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0037
74062341|NCT00038467|147676895|SUPERIORITY_OR_OTHER|||||||0.8084|TWO_SIDED||||||Chi-squared|||12 months post-treatment: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.8084
73882527|NCT05893862|147299052|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|2.79|||||TWO_SIDED|90.0|0.81|4.76||||||||4.76|0.81|
73882528|NCT05893862|147299055|OTHER|LS Mean Difference 0.5 Hr|LS Mean Difference|0.52|||||TWO_SIDED|90.0|-1.11|2.14||||||||2.14|-1.11|
73882529|NCT05893862|147299055|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|0.36|||||TWO_SIDED|90.0|-1.26|1.98||||||||1.98|-1.26|
74062342|NCT00038467|147676895|SUPERIORITY_OR_OTHER|||||||0.6449|TWO_SIDED||||||Chi-squared|||24 months post-treatment: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.6449
74062343|NCT01988493|147676903|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.46||||0.0087|TWO_SIDED|90.0|0.28|0.76|||Log Rank|||||0.76|0.28|0.0087
74062344|NCT01988493|147676904|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.53||||0.0229||90.0|0.33|0.84|||Log Rank|||||0.84|0.33|0.0229
74062345|NCT01988493|147676905|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.71||||0.2333||90.0|0.45|1.14|||Log Rank|||||1.14|0.45|0.2333
74062346|NCT01988493|147676906|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.45||||0.0059||90.0|0.28|0.73|||Log Rank|||||0.73|0.28|0.0059
74062347|NCT01988493|147676919|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|1.04||||0.8915||90.0|0.62|1.77|||Log Rank|||||1.77|0.62|0.8915
73882530|NCT05893862|147299055|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|1.31|||||TWO_SIDED|90.0|-1.04|3.66||||||||3.66|-1.04|
73882531|NCT05893862|147299055|OTHER|LS Mean Difference 3 hr|LS Mean Difference|4.27|||||TWO_SIDED|90.0|1.9|6.64||||||||6.64|1.90|
74062348|NCT01988493|147676920|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0438|||||||Cochran-Mantel-Haenszel|||||||0.0438
74062349|NCT01988493|147676922|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.59||||0.0496|TWO_SIDED|90.0|0.38|0.92|||Log Rank|||||0.92|0.38|0.0496
74062350|NCT01988493|147676923|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0527|||||||Cochran-Mantel-Haenszel|||||||0.0527
74062351|NCT02268045|147676964|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|Percentage difference|0.7|||||ONE_SIDED|95.0|-13.0||||||For the ITT population||||-13|
74062352|NCT02268045|147676964|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|percentage difference|3.0|||||ONE_SIDED|95.0|-13.0||||||For the PP population||||-13|
74062353|NCT02268045|147676965|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|99.2|||||TWO_SIDED|90.0|93.6|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||105|93.6|
73882532|NCT05893862|147299055|OTHER|LS Mean Difference 4 Hr|LS Mean Difference|7.0|||||TWO_SIDED|90.0|4.35|9.64||||||||9.64|4.35|
74062354|NCT02268045|147676966|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|103.0|||||TWO_SIDED|90.0|98.5|107.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||107|98.5|
74062355|NCT02268045|147676967|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|99.6|||||TWO_SIDED|90.0|93.9|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||105|93.9|
74062356|NCT02268045|147676968|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|104.0|||||TWO_SIDED|90.0|99.5|109.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||109|99.5|
74062357|NCT02268045|147676972|OTHER|||||||0.457|||||||Log Rank|||||||0.4570
74062358|NCT01766310|147676973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68|STANDARD_DEVIATION|1.3||0.05|TWO_SIDED|95.0|-0.09|1.44|||t-test, 2 sided|||||1.44|-0.09|0.05
74062359|NCT01154673|147676977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.056|TWO_SIDED|95.0|-0.006|0.4||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"|Regression, Linear||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"|||0.4|-.006|0.056
74062360|NCT02617446|147676983|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.029|TWO_SIDED|95.0|-5.68|-0.32||Alpha set at 0.05.|ANOVA|Treatment term included in the model||Null hypothesis: No difference in E/Ea ratio between istaroxime and placebo||-0.32|-5.68|0.029
74062361|NCT02617446|147676983|SUPERIORITY||Mean Difference (Final Values)|-2.08||||0.009|TWO_SIDED|95.0|-3.61|-0.55||Alpha set at 0.05.|ANOVA|Treatment term included in the model||Null hypothesis: No difference in E/Ea ratio between istaroxime and placebo||-0.55|-3.61|0.009
73882533|NCT05893862|147299055|OTHER|LS Mean Difference 6 Hr|LS Mean Difference|7.85|||||TWO_SIDED|90.0|4.35|9.64||||||||9.64|4.35|
74062362|NCT02617446|147676984|SUPERIORITY||Mean Difference (Final Values)|1.7632||||0.089|TWO_SIDED|95.0|-0.2751|3.8014||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term included in the model||Null hypothesis: No difference in LVEF % between istaroxime and placebo participants.||3.8014|-0.2751|0.089
74062363|NCT02617446|147676984|SUPERIORITY||Mean Difference (Final Values)|0.9848||||0.423|TWO_SIDED|95.0|-1.4668|3.4365||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term included in the model||Null hypothesis: No difference in LVEF % between istaroxime and placebo participants.||3.4365|-1.4668|0.423
74062364|NCT02617446|147676985|SUPERIORITY||Mean Difference (Final Values)|3.684||||0.034|TWO_SIDED|95.0|0.285|7.083||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model.||Null hypothesis: No difference in SVI between istaroxime and placebo participants.||7.083|0.285|0.034
74062365|NCT02617446|147676985|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.09|TWO_SIDED|95.0|-0.373|4.992||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||4.992|-0.373|0.090
74062366|NCT02617446|147676986|SUPERIORITY||Mean Difference (Final Values)|-0.777||||0.042|TWO_SIDED|95.0|-1.522|-0.032||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is included in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||-0.032|-1.522|0.042
74062367|NCT02617446|147676986|SUPERIORITY||Mean Difference (Final Values)|-0.829||||0.029|TWO_SIDED|95.0|-1.568|-0.091||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||-0.091|-1.568|0.029
74062368|NCT02617446|147676987|SUPERIORITY||Mean Difference (Final Values)|-5.368||||0.11|TWO_SIDED|95.0|-11.999|1.262||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in LVESV between istaroxime and placebo participants.||1.262|-11.999|0.110
74062369|NCT02617446|147676987|SUPERIORITY||Mean Difference (Final Values)|0.439||||0.931|TWO_SIDED|95.0|-9.735|10.614||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in LVEDV between istaroxime and placebo participants.||10.614|-9.735|0.931
74062370|NCT02617446|147676988|SUPERIORITY||Mean Difference (Final Values)|-1.657||||0.589|TWO_SIDED|95.0|-7.777|4.461||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||4.461|-7.777|0.589
74062371|NCT02617446|147676988|SUPERIORITY||Mean Difference (Final Values)|3.944||||0.424|TWO_SIDED|95.0|-5.886|13.774||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model.||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||13.774|-5.886|0.424
74062372|NCT02617446|147676989|SUPERIORITY|Linear mixed model with treatment, center, timepoint, gender, baseline cTnT value, atrial fibrillation, and treatment\*timepoint interaction included in the model.|Mean Difference (Final Values)|-0.041||||0.987|TWO_SIDED|95.0|-5.216|5.133||Unadjusted alpha of 0.05 is the threshold for statistical significance.|Mixed Models Analysis|Kenward-Roger adjustment used for the degrees of freedom.||Null hypothesis: no difference between treatment groups||5.133|-5.216|0.987
74062373|NCT02617446|147676989|SUPERIORITY|Linear mixed model with treatment, center, timepoint, gender, baseline cTnT value, atrial fibrillation, and treatment\*timepoint interaction included in the model.|Mean Difference (Final Values)|3.015||||0.251|TWO_SIDED|95.0|-2.168|8.198||Unadjusted alpha of 0.05 is the threshold for statistical significance.|Mixed Models Analysis|Kenward-Roger adjustment used for the degrees of freedom.||Null hypothesis: no difference between treatment groups.||8.198|-2.168|0.251
74062374|NCT01556490|147677015|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4552|TWO_SIDED|95.0|0.89|1.31|||Log Rank|||||1.31|0.89|0.4552
73882534|NCT05893862|147299055|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|9.25|||||TWO_SIDED|90.0|6.71|11.8||||||||11.80|6.71|
73882535|NCT05893862|147299055|OTHER|LS Mean Difference 12 Hr|LS Mean Difference|4.81|||||TWO_SIDED|90.0|2.27|7.35||||||||7.35|2.27|
73882536|NCT05893862|147299055|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|3.57|||||TWO_SIDED|90.0|0.91|6.23||||||||6.23|0.91|
73882537|NCT05893862|147299055|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|5.01|||||TWO_SIDED|90.0|3.18|6.85||||||||6.85|3.18|
74062375|NCT01556490|147677016|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0626|TWO_SIDED|95.0|0.61|1.01|||Log Rank|||||1.01|0.61|0.0626
74062376|NCT01556490|147677017|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0227|TWO_SIDED|95.0|0.59|0.96|||Log Rank|||||.96|.59|0.0227
74062377|NCT01556490|147677018|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0043|TWO_SIDED|95.0|0.52|0.89|||Log Rank|||||.89|.52|0.0043
74062378|NCT01556490|147677019|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.0001|TWO_SIDED|95.0|8.6|22.3|||2 sided calculated using continuity|2 sided calculated using continuity adjusted Wald Approach||||22.3|8.6|0.0001
74062379|NCT04529096|147677025|SUPERIORITY||Posterior Mean Difference|0.52|||||TWO_SIDED|95.0|-0.1|1.14|||Bayesian Mixed Model Analysis|||||1.14|-0.10|
74062380|NCT04529096|147677026|SUPERIORITY||Posterior Mean Difference|1.05|||||TWO_SIDED|95.0|-0.46|2.56|||Bayesian Mixed Model Analysis|||||2.56|-0.46|
74062381|NCT04529096|147677027|SUPERIORITY||Posterior Mean Difference|0.16|||||TWO_SIDED|95.0|-0.25|0.58|||Bayesian Mixed Model Analysis|||||0.58|-0.25|
74062382|NCT04529096|147677028|SUPERIORITY||Posterior Mean Difference|0.48|||||TWO_SIDED|95.0|-0.19|1.17|||Bayesian Mixed Model Analysis|||||1.17|-0.19|
74062383|NCT04529096|147677029|SUPERIORITY||Posterior Mean Difference|4.63|||||TWO_SIDED|95.0|-3.51|12.59|||Bayesian Mixed Model Analysis|||||12.59|-3.51|
74062384|NCT04529096|147677030|SUPERIORITY||Posterior Mean Difference|0.05|||||TWO_SIDED|95.0|-0.4|0.51|||Bayesian Mixed Model Analysis|||||0.51|-0.40|
74062385|NCT04529096|147677031|SUPERIORITY||Posterior Mean Difference|-15.18|||||TWO_SIDED|95.0|-206.43|175.8|||Bayesian Mixed Model Analysis|||||175.80|-206.43|
74062386|NCT04529096|147677032|SUPERIORITY||Posterior Mean Difference|-0.05|||||TWO_SIDED|95.0|-0.11|0.01|||Bayesian Mixed Model Analysis|||||0.01|-0.11|
74062387|NCT03985293|147677041|SUPERIORITY||Difference in LS Mean|-0.47||||0.0071|TWO_SIDED|90.0|-0.76|-0.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.18|-0.76|0.0071
74062388|NCT03985293|147677041|SUPERIORITY||Difference in LS Mean|-0.9|||<|0.0001|TWO_SIDED|90.0|-1.18|-0.62|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.62|-1.18|<.0001
74062389|NCT03985293|147677041|SUPERIORITY||Difference in LS Mean|-1.01|||<|0.0001|TWO_SIDED|90.0|-1.3|-0.73|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.73|-1.30|<.0001
74062390|NCT03985293|147677041|SUPERIORITY||Difference in LS Mean|-0.94|||<|0.0001|TWO_SIDED|90.0|-1.24|-0.65|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.65|-1.24|<.0001
73882538|NCT05893862|147299055|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|3.95|||||TWO_SIDED|90.0|1.56|6.34||||||||6.34|1.56|
73882539|NCT05893862|147299055|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|3.92|||||TWO_SIDED|90.0|1.49|6.35||||||||6.35|1.49|
74062391|NCT03985293|147677041|SUPERIORITY||Difference in LS Mean|-1.16|||<|0.0001|TWO_SIDED|90.0|-1.47|-0.86|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.86|-1.47|<.0001
74062392|NCT03985293|147677042|SUPERIORITY||Odds Ratio (OR)|5.11|||||TWO_SIDED|90.0|1.84|14.18|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||14.18|1.84|
74062393|NCT03985293|147677042|SUPERIORITY||Odds Ratio (OR)|16.85|||||TWO_SIDED|90.0|6.18|45.93|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||45.93|6.18|
73882540|NCT05893862|147299055|OTHER|LS Mean Difference 3 Hr|LS Mean Difference|4.68|||||TWO_SIDED|90.0|2.33|7.03||||||||7.03|2.33|
73882541|NCT05893862|147299055|OTHER|LS Mean Difference 4 Hr|LS Mean Difference|4.79|||||TWO_SIDED|90.0|2.45|7.12||||||||7.12|2.45|
74062394|NCT03985293|147677042|SUPERIORITY||Odds Ratio (OR)|18.79|||||TWO_SIDED|90.0|7.03|50.21|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||50.21|7.03|
74062395|NCT03985293|147677042|SUPERIORITY||Odds Ratio (OR)|23.97|||||TWO_SIDED|90.0|8.66|66.39|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||66.39|8.66|
74062396|NCT03985293|147677042|SUPERIORITY||Odds Ratio (OR)|24.46|||||TWO_SIDED|90.0|8.72|68.57|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||68.57|8.72|
74062397|NCT03985293|147677043|SUPERIORITY||Difference in LS Mean|-0.09||||0.1578|TWO_SIDED|90.0|-0.19|0.01|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.01|-0.19|0.1578
74062398|NCT03985293|147677043|SUPERIORITY||Difference in LS Mean|-0.22||||0.0003|TWO_SIDED|90.0|-0.32|-0.12|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.12|-0.32|0.0003
73882542|NCT05893862|147299055|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|4.82|||||TWO_SIDED|90.0|1.93|7.71||||||||7.71|1.93|
73882543|NCT05893862|147299055|OTHER|LS Mean Difference 11 Hr|LS Mean Difference|5.3|||||TWO_SIDED|90.0|2.51|8.09||||||||8.09|2.51|
74062399|NCT03985293|147677043|SUPERIORITY||Difference in LS Mean|-0.2||||0.0013|TWO_SIDED|90.0|-0.3|-0.1|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.10|-0.30|0.0013
74062400|NCT03985293|147677043|SUPERIORITY||Difference in LS Mean|-0.24||||0.0001|TWO_SIDED|90.0|-0.34|-0.14|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.14|-0.34|0.0001
74062401|NCT03985293|147677043|SUPERIORITY||Difference in LS Mean|-0.26|||<|0.0001|TWO_SIDED|90.0|-0.36|-0.16|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.16|-0.36|<.0001
74062402|NCT03985293|147677044|SUPERIORITY||Difference in LS Mean|-0.3||||0.0013|TWO_SIDED|90.0|-0.46|-0.15|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.15|-0.46|0.0013
74062403|NCT03985293|147677044|SUPERIORITY||Difference in LS Mean|-0.43|||<|0.0001|TWO_SIDED|90.0|-0.58|-0.28|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.28|-0.58|<.0001
74062404|NCT03985293|147677044|SUPERIORITY||Difference in LS Mean|-0.55|||<|0.0001|TWO_SIDED|90.0|-0.7|-0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.40|-0.70|<.0001
74062405|NCT03985293|147677044|SUPERIORITY||Difference in LS Mean|-0.5|||<|0.0001|TWO_SIDED|90.0|-0.66|-0.35|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.35|-0.66|<.0001
74062406|NCT03985293|147677044|SUPERIORITY||Difference in LS Mean|-0.56|||<|0.0001|TWO_SIDED|90.0|-0.71|-0.41|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.41|-0.71|<.0001
73882544|NCT05893862|147299055|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|5.85|||||TWO_SIDED|90.0|2.97|8.74||||||||8.74|2.97|
74062407|NCT03985293|147677045|SUPERIORITY||Difference in LS Mean|-0.4||||0.0004|TWO_SIDED|90.0|-0.59|-0.22|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.22|-0.59|0.0004
74062408|NCT03985293|147677045|SUPERIORITY||Difference in LS Mean|-0.64|||<|0.0001|TWO_SIDED|90.0|-0.81|-0.46|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.46|-0.81|<.0001
74062409|NCT03985293|147677045|SUPERIORITY||Difference in LS Mean|-0.77|||<|0.0001|TWO_SIDED|90.0|-0.95|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-0.95|<.0001
74062410|NCT03985293|147677045|SUPERIORITY||Difference in LS Mean|-0.72|||<|0.0001|TWO_SIDED|90.0|-0.91|-0.53|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.53|-0.91|<.0001
74062411|NCT03985293|147677045|SUPERIORITY||Difference in LS Mean|-0.77|||<|0.0001|TWO_SIDED|90.0|-0.95|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-0.95|<.0001
74062412|NCT03985293|147677046|SUPERIORITY||Difference in LS Mean|-0.37||||0.0054|TWO_SIDED|90.0|-0.59|-0.15|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.15|-0.59|0.0054
74062413|NCT03985293|147677046|SUPERIORITY||Difference in LS Mean|-0.65|||<|0.0001|TWO_SIDED|90.0|-0.86|-0.44|||Mixed Models Analysis||PF-06882961 = Test Placebo = Reference|||-0.44|-0.86|<.0001
74062414|NCT03985293|147677046|SUPERIORITY||Difference in LS Mean|-0.84|||<|0.0001|TWO_SIDED|90.0|-1.06|-0.63|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.63|-1.06|<.0001
74062415|NCT03985293|147677046|SUPERIORITY||Difference in LS Mean|-0.8|||<|0.0001|TWO_SIDED|90.0|-1.02|-0.57|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.57|-1.02|<.0001
74062416|NCT03985293|147677046|SUPERIORITY||Difference in LS Mean|-0.89|||<|0.0001|TWO_SIDED|90.0|-1.11|-0.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.67|-1.11|<.0001
74062417|NCT03985293|147677047|SUPERIORITY||Difference in LS Mean|-0.44||||0.0061|TWO_SIDED|90.0|-0.71|-0.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.18|-0.71|0.0061
74062418|NCT03985293|147677047|SUPERIORITY||Difference in LS Mean|-0.79|||<|0.0001|TWO_SIDED|90.0|-1.05|-0.54|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.54|-1.05|<.0001
74062419|NCT03985293|147677047|SUPERIORITY||Difference in LS Mean|-0.98|||<|0.0001|TWO_SIDED|90.0|-1.24|-0.72|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.72|-1.24|<.0001
74062420|NCT03985293|147677047|SUPERIORITY||Difference in LS Mean|-0.83|||<|0.0001|TWO_SIDED|90.0|-1.1|-0.56|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.56|-1.10|<.0001
74062421|NCT03985293|147677047|SUPERIORITY||Difference in LS Mean|-1.03|||<|0.0001|TWO_SIDED|90.0|-1.3|-0.75|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.75|-1.30|<.0001
74062422|NCT03985293|147677048|SUPERIORITY||Difference in LS Mean|-17.13||||0.0014|TWO_SIDED|90.0|-25.94|-8.33|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-8.33|-25.94|0.0014
74062423|NCT03985293|147677048|SUPERIORITY||Difference in LS Mean|-16.38||||0.0021|TWO_SIDED|90.0|-25.08|-7.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|Difference in LS Mean|||-7.67|-25.08|0.0021
74062424|NCT03985293|147677048|SUPERIORITY||Difference in LS Mean|-22.2|||<|0.0001|TWO_SIDED|90.0|-30.88|-13.53|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-13.53|-30.88|<.0001
73882545|NCT05893862|147299055|OTHER|LS Mean Difference 16 Hr|LS Mean Difference|4.12|||||TWO_SIDED|90.0|1.79|6.45||||||||6.45|1.79|
73882546|NCT05893862|147299055|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|0.78|||||TWO_SIDED|90.0|-1.69|3.26||||||||3.26|-1.69|
73882547|NCT02919761|147299062|OTHER||||||=|0.242||||||At Week 4|One-sample binomial test|||||||=0.242
73882548|NCT02919761|147299062|OTHER||||||<|0.0001||||||At Week 8|One-sample binomial test|||||||<0.0001
73882549|NCT02919761|147299062|OTHER||||||<|0.0001|||||||One-sample binomial test|||||||<0.0001
73882550|NCT02919761|147299063|OTHER||||||=|0.313||||||Comparison at Week 12|Pearson's Chi-square test|||||||=0.313
73882551|NCT02919761|147299063|OTHER||||||=|0.439||||||Comparison at Week 16|Pearson's Chi-square test|||||||=0.439
74062425|NCT03985293|147677048|SUPERIORITY||Difference in LS Mean|-18.59||||0.0006|TWO_SIDED|90.0|-27.43|-9.76|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-9.76|-27.43|0.0006
74062426|NCT03985293|147677048|SUPERIORITY||Difference in LS Mean|-25.33|||<|0.0001|TWO_SIDED|90.0|-34.0|-16.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-16.67|-34.00|<.0001
74062427|NCT03985293|147677049|SUPERIORITY||Difference in LS Mean|-11.79||||0.0468|TWO_SIDED|90.0|-21.55|-2.04|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.04|-21.55|0.0468
74062428|NCT03985293|147677049|SUPERIORITY||Difference in LS Mean|-18.68||||0.0012|TWO_SIDED|90.0|-28.12|-9.25|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-9.25|-28.12|0.0012
74062429|NCT03985293|147677049|SUPERIORITY||Difference in LS Mean|-27.44|||<|0.0001|TWO_SIDED|90.0|-37.03|-17.85|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.85|-37.03|<.0001
74062430|NCT03985293|147677049|SUPERIORITY||Difference in LS Mean|-27.36|||<|0.0001|TWO_SIDED|90.0|-37.22|-17.51|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.51|-37.22|<.0001
74062431|NCT03985293|147677049|SUPERIORITY||Difference in LS Mean|-28.09|||<|0.0001|TWO_SIDED|90.0|-37.72|-18.45|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-18.45|-37.72|<.0001
74062432|NCT03985293|147677050|SUPERIORITY||Difference in LS Mean|-15.9||||0.0091|TWO_SIDED|90.0|-25.9|-5.9|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-5.90|-25.90|0.0091
74062433|NCT03985293|147677050|SUPERIORITY||Difference in LS Mean|-25.53|||<|0.0001|TWO_SIDED|90.0|-35.18|-15.89|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-15.89|-35.18|<.0001
74062434|NCT03985293|147677050|SUPERIORITY||Difference in LS Mean|-30.01|||<|0.0001|TWO_SIDED|90.0|-39.8|-20.21|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.21|-39.80|<.0001
74062435|NCT03985293|147677050|SUPERIORITY||Difference in LS Mean|-27.48|||<|0.0001|TWO_SIDED|90.0|-37.63|-17.33|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.33|-37.63|<.0001
74062436|NCT03985293|147677050|SUPERIORITY||Difference in LS Mean|-31.77|||<|0.0001|TWO_SIDED|90.0|-41.77|-21.78|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-21.78|-41.77|<.0001
74062437|NCT03985293|147677051|SUPERIORITY||Difference in LS Mean|-3.63||||0.5449|TWO_SIDED|90.0|-13.51|6.25|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||6.25|-13.51|0.5449
74062438|NCT03985293|147677051|SUPERIORITY||Difference in LS Mean|-17.12||||0.0031|TWO_SIDED|90.0|-26.62|-7.63|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-7.63|-26.62|0.0031
74062439|NCT03985293|147677051|SUPERIORITY||Difference in LS Mean|-20.64||||0.0005|TWO_SIDED|90.0|-30.31|-10.96|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-10.96|-30.31|0.0005
74062440|NCT03985293|147677051|SUPERIORITY||Difference in LS Mean|-24.12|||<|0.0001|TWO_SIDED|90.0|-34.2|-14.04|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.04|-34.20|<.0001
74062441|NCT03985293|147677051|SUPERIORITY||Difference in LS Mean|-25.21|||<|0.0001|TWO_SIDED|90.0|-35.44|-14.97|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.97|-35.44|<.0001
74062442|NCT03985293|147677052|SUPERIORITY||Difference in LS Mean|-7.7||||0.294|TWO_SIDED|90.0|-19.78|4.38|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||4.38|-19.78|0.2940
74062443|NCT03985293|147677052|SUPERIORITY||Difference in LS Mean|-23.77||||0.0008|TWO_SIDED|90.0|-35.37|-12.17|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-12.17|-35.37|0.0008
74062444|NCT03985293|147677052|SUPERIORITY||Difference in LS Mean|-33.23|||<|0.0001|TWO_SIDED|90.0|-45.05|-21.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-21.40|-45.05|<.0001
74062445|NCT03985293|147677052|SUPERIORITY||Difference in LS Mean|-31.66|||<|0.0001|TWO_SIDED|90.0|-44.14|-19.19|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-19.19|-44.14|<.0001
74062446|NCT03985293|147677052|SUPERIORITY||Difference in LS Mean|-33.59|||<|0.0001|TWO_SIDED|90.0|-46.67|-20.51|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.51|-46.67|<.0001
74062447|NCT03985293|147677053|SUPERIORITY||Difference in LS Mean|-14.12||||0.0464|TWO_SIDED|90.0|-25.77|-2.47|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.47|-25.77|0.0464
74062448|NCT03985293|147677053|SUPERIORITY||Difference in LS Mean|-25.84||||0.0002|TWO_SIDED|90.0|-37.05|-14.62|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.62|-37.05|0.0002
74062449|NCT03985293|147677053|SUPERIORITY||Difference in LS Mean|-31.78|||<|0.0001|TWO_SIDED|90.0|-43.2|-20.35|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.35|-43.20|<.0001
74062450|NCT03985293|147677053|SUPERIORITY||Difference in LS Mean|-27.02||||0.0002|TWO_SIDED|90.0|-39.03|-15.01|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-15.01|-39.03|0.0002
74062451|NCT03985293|147677053|SUPERIORITY||Difference in LS Mean|-33.24|||<|0.0001|TWO_SIDED|90.0|-45.63|-20.84|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.84|-45.63|<.0001
74062452|NCT03985293|147677054|SUPERIORITY||Difference in LS Mean|0.06||||0.8011|TWO_SIDED|90.0|-0.33|0.44|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.44|-0.33|0.8011
74062453|NCT03985293|147677054|SUPERIORITY||Difference in LS Mean|0.02||||0.9149|TWO_SIDED|90.0|-0.35|0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.40|-0.35|0.9149
74062454|NCT03985293|147677054|SUPERIORITY||Difference in LS Mean|-0.08||||0.7216|TWO_SIDED|90.0|-0.46|0.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.30|-0.46|0.7216
74062455|NCT03985293|147677054|SUPERIORITY||Difference in LS Mean|-0.42||||0.0758|TWO_SIDED|90.0|-0.8|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.03|-0.80|0.0758
73882552|NCT02919761|147299063|OTHER||||||=|0.028||||||Comparison at Week 20|Pearson's Chi-square test|||||||=0.028
74062456|NCT03985293|147677054|SUPERIORITY||Difference in LS Mean|-0.4||||0.086|TWO_SIDED|90.0|-0.77|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.02|-0.77|0.0860
74062457|NCT03985293|147677055|SUPERIORITY||Difference in LS Mean|-0.08||||0.7898|TWO_SIDED|90.0|-0.59|0.42|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.42|-0.59|0.7898
74062458|NCT03985293|147677055|SUPERIORITY||Difference in LS Mean|0.16||||0.5829|TWO_SIDED|90.0|-0.33|0.66|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.66|-0.33|0.5829
73882553|NCT02919761|147299063|OTHER||||||=|0.019||||||Comparison at Week 24|Pearson's Chi-square test|||||||=0.019
74062459|NCT03985293|147677055|SUPERIORITY||Difference in LS Mean|-0.52||||0.0827|TWO_SIDED|90.0|-1.02|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.03|-1.02|0.0827
74062460|NCT03985293|147677055|SUPERIORITY||Difference in LS Mean|-0.8||||0.0101|TWO_SIDED|90.0|-1.31|-0.29|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.29|-1.31|0.0101
74062461|NCT03985293|147677055|SUPERIORITY||Difference in LS Mean|-1.09||||0.0004|TWO_SIDED|90.0|-1.59|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-1.59|0.0004
74062462|NCT03985293|147677056|SUPERIORITY||Difference in LS Mean|-0.1||||0.7985|TWO_SIDED|90.0|-0.75|0.55|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.55|-0.75|0.7985
74062463|NCT03985293|147677056|SUPERIORITY||Difference in LS Mean|-0.23||||0.5484|TWO_SIDED|90.0|-0.86|0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.40|-0.86|0.5484
74062464|NCT03985293|147677056|SUPERIORITY||Difference in LS Mean|-0.75||||0.0541|TWO_SIDED|90.0|-1.38|-0.11|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.11|-1.38|0.0541
74062465|NCT03985293|147677056|SUPERIORITY||Difference in LS Mean|-1.6|||<|0.0001|TWO_SIDED|90.0|-2.26|-0.95|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.95|-2.26|<.0001
74062466|NCT03985293|147677056|SUPERIORITY||Difference in LS Mean|-2.25|||<|0.0001|TWO_SIDED|90.0|-2.9|-1.6|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.60|-2.90|<.0001
74062467|NCT03985293|147677057|SUPERIORITY||Difference in LS Mean|0.31||||0.4692|TWO_SIDED|90.0|-0.4|1.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.03|-0.40|0.4692
74062468|NCT03985293|147677057|SUPERIORITY||Difference in LS Mean|0.09||||0.8274|TWO_SIDED|90.0|-0.6|0.78|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.78|-0.60|0.8274
74062469|NCT03985293|147677057|SUPERIORITY||Difference in LS Mean|-0.72||||0.0887|TWO_SIDED|90.0|-1.42|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.02|-1.42|0.0887
73882554|NCT03349723|147299090|OTHER||Slope|0.9806|STANDARD_ERROR_OF_MEAN|0.0322|||TWO_SIDED|95.0|0.9155|1.0457|||||Based on the estimate for the slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate.||1.0457|0.9155|
73888255|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.19|||<|0.0001|TWO_SIDED|95.0|-15.99|-12.39|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-12.39|-15.99|<0.0001
73882555|NCT03349723|147299091|OTHER||Slope|0.9892|STANDARD_ERROR_OF_MEAN|0.0339|||TWO_SIDED|95.0|0.9207|1.0577|||||Based on the estimate for the slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate.||1.0577|0.9207|
74062470|NCT03985293|147677057|SUPERIORITY||Difference in LS Mean|-1.61||||0.0003|TWO_SIDED|90.0|-2.33|-0.88|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.88|-2.33|0.0003
74062471|NCT03985293|147677057|SUPERIORITY||Difference in LS Mean|-2.95|||<|0.0001|TWO_SIDED|90.0|-3.67|-2.22|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.22|-3.67|<.0001
74062472|NCT03985293|147677058|SUPERIORITY||Difference in LS Mean|0.15||||0.7758|TWO_SIDED|90.0|-0.7|0.99|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.99|-0.70|0.7758
74062473|NCT03985293|147677058|SUPERIORITY||Difference in LS Mean|0.23||||0.6367|TWO_SIDED|90.0|-0.58|1.05|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.05|-0.58|0.6367
74062474|NCT03985293|147677058|SUPERIORITY||Difference in LS Mean|-0.81||||0.1082|TWO_SIDED|90.0|-1.63|0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.02|-1.63|0.1082
74062475|NCT03985293|147677058|SUPERIORITY||Difference in LS Mean|-2.28|||<|0.0001|TWO_SIDED|90.0|-3.14|-1.42|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.42|-3.14|<.0001
74062476|NCT03985293|147677058|SUPERIORITY||Difference in LS Mean|-3.57|||<|0.0001|TWO_SIDED|90.0|-4.44|-2.7|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.70|-4.44|<.0001
74062477|NCT03985293|147677059|SUPERIORITY||Difference in LS Mean|0.45||||0.4325|TWO_SIDED|90.0|-0.5|1.41|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.41|-0.50|0.4325
74062478|NCT03985293|147677059|SUPERIORITY||Difference in LS Mean|0.38||||0.4978|TWO_SIDED|90.0|-0.54|1.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.30|-0.54|0.4978
74062479|NCT03985293|147677059|SUPERIORITY||Difference in LS Mean|-0.73||||0.197|TWO_SIDED|90.0|-1.66|0.2|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.20|-1.66|0.1970
74062480|NCT03985293|147677059|SUPERIORITY||Difference in LS Mean|-2.04||||0.0006|TWO_SIDED|90.0|-3.01|-1.07|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.07|-3.01|0.0006
74062481|NCT03985293|147677059|SUPERIORITY||Difference in LS Mean|-4.17|||<|0.0001|TWO_SIDED|90.0|-5.15|-3.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-3.18|-5.15|<.0001
73882556|NCT02973100|147299101|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.07|-0.53|||Mixed Models Analysis|||||-0.53|-1.07|<.001
74062482|NCT01345058|147677073|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.49|TWO_SIDED|95.0|0.35|1.65|||Chi-squared||Hazard ratio for seizure occurrence for polytherapy relative to monotherapy.|||1.65|0.35|0.49
74062483|NCT01892020|147677089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.27|<|0.001||95.0|-1.66|-0.58||The 2-h PPG increment was analyzed using a normal linear mixed model with period and treatment as fixed effects and subject as a random effect.|Mixed Models Analysis|||Let D be the treatment difference (BIAsp 50 BID + metformin minus BHI 50 BID + metformin) of 2-h PPG increment after a 4-week treatment. The null hypothesis was D = 0 mmol/L. The alternative hypothesis was D ≠ 0 mmol/L. Sample size was determined using a two-sided one sample t-test at a = 0.05 under the assumption of 0.8 mmol/L mean treatment different and 80% power.||-0.58|-1.66|< 0.001
74062484|NCT04876482|147677174|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|-10.76|||<|0.05|TWO_SIDED||||||Regression, Linear|||"We hypothesized that the improvements in the AHI would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).~."||||<0.05
74062485|NCT04876482|147677175|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.05|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the upper airway volume would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
74062486|NCT04876482|147677176|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|0.275|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the minimal area on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls)||||<0.05
74062487|NCT04876482|147677177|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|-0.14|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the anteror to posterior distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
73882557|NCT02973100|147299101|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.001|TWO_SIDED|95.0|-1.14|-0.6|||Mixed Models Analysis|||||-0.60|-1.14|<0.001
73882558|NCT02973100|147299101|SUPERIORITY||Mean Difference (Final Values)|-0.96|||<|0.001|TWO_SIDED|95.0|-1.24|-0.69|||Mixed Models Analysis|||||-0.69|-1.24|<.001
73882559|NCT02973100|147299102|SUPERIORITY||Odds Ratio (OR)|24.489|||<|0.001|TWO_SIDED|95.0|8.368|71.667|||Regression, Logistic|||||71.667|8.368|<.001
73882560|NCT02973100|147299102|SUPERIORITY||Odds Ratio (OR)|27.906|||<|0.001|TWO_SIDED|95.0|9.238|84.3|||Regression, Logistic|||||84.300|9.238|<.001
73882561|NCT02973100|147299102|SUPERIORITY||Odds Ratio (OR)|21.852|||<|0.001|TWO_SIDED|95.0|7.672|62.242|||Regression, Logistic|||||62.242|7.672|<.001
73882562|NCT02973100|147299103|SUPERIORITY||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-2.02|-0.62|||Mixed Models Analysis|||||-0.62|-2.02|<0.001
73882563|NCT02973100|147299103|SUPERIORITY||Mean Difference (Final Values)|-1.23|||<|0.001|TWO_SIDED|95.0|-1.91|-0.54|||Mixed Models Analysis|||||-0.54|-1.91|<0.001
73882564|NCT02973100|147299103|SUPERIORITY||Mean Difference (Final Values)|-1.42|||<|0.001|TWO_SIDED|95.0|-2.12|-0.72|||Mixed Models Analysis|||||-0.72|-2.12|<0.001
74062488|NCT04876482|147677178|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the lateral distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
74062489|NCT04876482|147677179|OTHER|Baseline characteristics among the study groups were compared using Fisher exact test for categorical variables. McNemar chi-square test used for within-group analysis.|Number and percentage|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||We hypothesized that TORS followed by OPR would improve upper airway obstruction more compared with TORS alone and conservative treatment (control).||||<0.05
74062490|NCT04876482|147677180|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.23|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the jaw opening muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
74062491|NCT04876482|147677181|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.45|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue protrusion muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
74062492|NCT04876482|147677182|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|4.81|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue elevation muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
74062493|NCT04876482|147677183|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|7.01|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue depression muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
73882565|NCT02973100|147299104|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.025|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|||||-0.2|-2.3|0.025
74062494|NCT04876482|147677184|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|3.67|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue lateralization muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
74062495|NCT00391092|147677217|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0775|TWO_SIDED|95.0|0.65|1.02|||Log Rank (unstratified)|||||1.02|0.65|0.0775
74062496|NCT00391092|147677218|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9543|TWO_SIDED|95.0|0.74|1.38|||Log Rank|||||1.38|0.74|0.9543
74062497|NCT00391092|147677219|SUPERIORITY_OR_OTHER||Difference in Response rates|4.43||||0.3492|TWO_SIDED|95.0|-5.2|14.0|||Chi-squared||95% CI for the difference in response rates using Hauck-Anderson method.|||14.0|-5.2|0.3492
74062498|NCT00391092|147677220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.56|0.98||||||||0.98|0.56|
74062499|NCT00391092|147677221|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5392|TWO_SIDED|95.0|0.76|1.15|||Log Rank|||||1.15|0.76|0.5392
73882566|NCT02973100|147299104|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.4|-1.3|||Mixed Models Analysis|||||-1.3|-3.4|<0.001
74062500|NCT01143272|147677225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.94|TWO_SIDED|95.0|0.55|1.9|||Regression, Cox|||||1.90|0.55|0.94
74062501|NCT01143272|147677225|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||0.25
74062502|NCT01143272|147677225|SUPERIORITY_OR_OTHER|||||||0.87|||||||Log Rank|||||||0.87
73882567|NCT02973100|147299104|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.7|-1.5|||Mixed Models Analysis|||||-1.5|-3.7|<0.001
73888256|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.8784|TWO_SIDED|95.0|-3.63|3.11|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.11|-3.63|0.8784
74062503|NCT01143272|147677227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.8|TWO_SIDED|95.0|0.49|1.73|||Regression, Cox|||||1.73|0.49|0.80
74062504|NCT01143272|147677227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.93|TWO_SIDED|95.0|0.53|2.03||adjusting for age, sex, CRP, leukocyte count, duration of antibiotic treatment, and administration of antibiotics|Regression, Cox|||||2.03|0.53|0.93
74062505|NCT01143272|147677228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.6|TWO_SIDED|95.0|0.96|1.08||Association between initial leukocyte count and incidence of AAD|Regression, Logistic|||||1.08|0.96|0.6
74062506|NCT01143272|147677228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.653|TWO_SIDED|95.0|1.0|1.01||Association between the initial C-reactive protein and incidence of AAD|Regression, Logistic|||||1.01|1.00|0.653
74062507|NCT00545181|147677259|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Chi-squared, Corrected|||||||0.75
74062508|NCT02016755|147677290|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||Overall (LOCF)||||0.331
74062509|NCT02016755|147677290|SUPERIORITY|||||||0.362|||||||t-test, 2 sided|||Activity (LOCF)||||0.362
74062510|NCT02016755|147677290|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||Emotional (LOCF)||||0.159
74062511|NCT02016755|147677290|SUPERIORITY|||||||0.468|||||||t-test, 2 sided|||Pain (LOCF)||||0.468
74062512|NCT02016755|147677290|SUPERIORITY|||||||0.197|||||||t-test, 2 sided|||Social (LOCF)||||0.197
73882568|NCT00960622|147299123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|8.5|<|0.05|TWO_SIDED|95.0|-6.3|11.3|||t-test, 2 sided|||"Paired t-tests for inter-group differences between baseline and end-of-study measurements.Regression analysis, physiological correlates of statistically significant between-group changes.~P\<0.05 chosen for statistical significance"||11.3|-6.3|<0.05
74062513|NCT02016755|147677290|SUPERIORITY|||||||0.448|||||||t-test, 2 sided|||Symptom (LOCF)||||0.448
74062514|NCT02016755|147677291|SUPERIORITY|||||||0.939|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.939
74062515|NCT02016755|147677291|SUPERIORITY|||||||0.508|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.508
74062516|NCT02016755|147677291|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.474
74062517|NCT02016755|147677291|SUPERIORITY|||||||0.361|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.361
74062518|NCT02016755|147677291|SUPERIORITY|||||||0.258|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.258
74062519|NCT02016755|147677291|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||Change from baseline at Month 18||||0.059
74062520|NCT02016755|147677291|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.023
74062521|NCT02016755|147677292|SUPERIORITY|||||||0.655|||||||t-test, 2 sided|||Change from Baseline at Month 3 (Dorsalis pedis)||||0.655
74062522|NCT02016755|147677292|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Change from Baseline at Month 6 (Dorsalis pedis)||||0.310
74062523|NCT02016755|147677292|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||Change from Baseline at Month 9 (Dorsalis pedis)||||0.348
74062524|NCT02016755|147677292|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||Change from Baseline at Month 12 (Dorsalis pedis)||||0.501
74062525|NCT02016755|147677292|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||Change from Baseline at Month 15 (Dorsalis pedis)||||0.536
74062526|NCT02016755|147677292|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change from Baseline at Month 18 (Dorsalis pedis)||||0.140
74062527|NCT02016755|147677292|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||Change from Baseline at LOCF (Dorsalis pedis)||||0.018
74062528|NCT02016755|147677292|SUPERIORITY|||||||0.716|||||||t-test, 2 sided|||Change from baseline at Month 3 (Posterior tibial)||||0.716
74062529|NCT02016755|147677292|SUPERIORITY|||||||0.641|||||||t-test, 2 sided|||Change from baseline at Month 6 (Posterior tibial)||||0.641
74062530|NCT02016755|147677292|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||Change from baseline at Month 9 (Posterior tibial)||||0.514
74062531|NCT02016755|147677292|SUPERIORITY|||||||0.808|||||||t-test, 2 sided|||Change from baseline at Month 12 (Posterior tibial)||||0.808
74062532|NCT02016755|147677292|SUPERIORITY|||||||0.396|||||||t-test, 2 sided|||Change from baseline at Month 15 (Posterior tibial)||||0.396
74062533|NCT02016755|147677292|SUPERIORITY|||||||0.162|||||||t-test, 2 sided|||Change from baseline at Month 18 (Posterior tibial)||||0.162
74062534|NCT02016755|147677292|SUPERIORITY|||||||0.259|||||||t-test, 2 sided|||Change from baseline at LOCF (Posterior tibial)||||0.259
74062535|NCT02016755|147677293|SUPERIORITY|||||||0.671|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.671
74062536|NCT02016755|147677293|SUPERIORITY|||||||0.925|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.925
74062537|NCT02016755|147677293|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.514
74062538|NCT02016755|147677293|SUPERIORITY|||||||0.302|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.302
74062539|NCT02016755|147677293|SUPERIORITY|||||||0.373|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.373
74062540|NCT02016755|147677293|SUPERIORITY|||||||0.505|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.505
74062541|NCT02016755|147677293|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.135
74062542|NCT02016755|147677293|SUPERIORITY|||||||0.175|||||||t-test, 2 sided|||Change from baseline at month 3 (Left)||||0.175
74062543|NCT02016755|147677293|SUPERIORITY|||||||0.393|||||||t-test, 2 sided|||Change from baseline at month 6 (Left)||||0.393
74062544|NCT02016755|147677293|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||Change from baseline at month 9 (Left)||||0.928
74062545|NCT02016755|147677293|SUPERIORITY|||||||0.429|||||||t-test, 2 sided|||Change from baseline at month 12 (Left)||||0.429
74062546|NCT02016755|147677293|SUPERIORITY|||||||0.907|||||||t-test, 2 sided|||Change from baseline at month 15 (Left)||||0.907
74062547|NCT02016755|147677293|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Change from baseline at month 18 (Left)||||0.300
74062548|NCT02016755|147677293|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||Change from baseline at LOCF (Left)||||0.214
74062549|NCT02016755|147677294|SUPERIORITY|||||||0.655|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.655
74062550|NCT02016755|147677294|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.226
74062551|NCT02016755|147677294|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.380
73882569|NCT01959503|147299130|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank-Sum Test|||||||<0.0001
73882570|NCT01959503|147299131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|4.07|19.89|||Regression, Logistic|||||19.89|4.07|<0.0001
74062552|NCT02016755|147677294|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.187
73882571|NCT01959503|147299132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.69|||<|0.0001|TWO_SIDED|95.0|3.27|18.11|||Regression, Logistic|||||18.11|3.27|<0.0001
74062553|NCT02016755|147677294|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.203
74062554|NCT02016755|147677294|SUPERIORITY|||||||0.074|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.074
74062555|NCT02016755|147677294|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.038
74062556|NCT02016755|147677295|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.246
74062557|NCT02016755|147677295|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.474
74062558|NCT02016755|147677295|SUPERIORITY|||||||0.395|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.395
74062559|NCT02016755|147677295|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.220
74062560|NCT02016755|147677295|SUPERIORITY|||||||0.454|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.454
74062561|NCT02016755|147677295|SUPERIORITY|||||||0.167|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.167
74062562|NCT02016755|147677295|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.015
73882572|NCT01600326|147299138|OTHER|Pair-wise comparison at Time point 1 compared to baseline|||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|See comments on P value||||||<0.0001
73882573|NCT01600326|147299138|SUPERIORITY||||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison||||<0.0001
74062563|NCT02533505|147677303|SUPERIORITY||Mean Difference (Final Values)|10.114||||0.007|TWO_SIDED|95.0|2.943|17.286||All p-values ≤ 0.05 after rounding will be considered statistically significant.|Mixed Models Analysis|||||17.286|2.943|0.007
74062564|NCT02533505|147677304|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.111|TWO_SIDED|95.0|-0.021|0.196|||Mixed Models Analysis|||||0.196|-0.021|0.111
74062565|NCT02533505|147677305|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.609|TWO_SIDED|95.0|-1.018|1.719|||Mixed Models Analysis|||ΔHR||1.719|-1.018|0.609
74062566|NCT02533505|147677306|SUPERIORITY||Mean Difference (Final Values)|0.191|||<|0.001|TWO_SIDED|95.0|0.15|0.233|||Mixed Models Analysis|||ΔFEV1||0.233|0.150|<0.001
73882574|NCT01600326|147299139|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>.99
73882575|NCT03224130|147299140|SUPERIORITY|||||||0.21|||||||Regression, Logistic|||||||0.21
73882576|NCT03224130|147299141|SUPERIORITY|||||||0.31|||||||Regression, Linear|||||||0.31
73882577|NCT03224130|147299142|SUPERIORITY|||||||0.24|||||||censored Poisson model|||||||0.24
73882578|NCT03224130|147299143|SUPERIORITY||||||<|0.01|||||||Poisson model|||||||<0.01
74062567|NCT02533505|147677306|SUPERIORITY||Mean Difference (Final Values)|0.312|||<|0.001|TWO_SIDED|95.0|0.236|0.388|||Mixed Models Analysis|||ΔFVC||0.388|0.236|<0.001
74062568|NCT02533505|147677306|SUPERIORITY||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.218|0.342|||Mixed Models Analysis|||ΔIC||0.342|0.218|<0.001
74062569|NCT02533505|147677307|SUPERIORITY||Mean Difference (Final Values)|23.315||||0.021|TWO_SIDED|95.0|3.723|42.907|||Mixed Models Analysis|||ΔVT/Ti||42.907|3.723|0.021
74062570|NCT02533505|147677308|SUPERIORITY||Mean Difference (Final Values)|-0.204||||0.106|TWO_SIDED|95.0|-0.454|0.045|||Mixed Models Analysis|||||0.045|-0.454|0.106
74062571|NCT02533505|147677309|SUPERIORITY||Mean Difference (Final Values)|10.245||||0.011|TWO_SIDED|95.0|2.469|18.021|||Mixed Models Analysis|||ΔVCO2||18.021|2.469|0.011
74062572|NCT02533505|147677310|SUPERIORITY||Mean Difference (Final Values)|0.242||||0.333|TWO_SIDED|95.0|-0.255|0.738|||Mixed Models Analysis|||ΔSaO2||0.738|-0.255|0.333
74062573|NCT02533505|147677311|SUPERIORITY||Mean Difference (Final Values)|0.237||||0.484|TWO_SIDED|95.0|-0.439|0.913|||Mixed Models Analysis|||ΔRR||0.913|-0.439|0.484
74062574|NCT02533505|147677312|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.113|TWO_SIDED|95.0|-0.004|0.036|||Mixed Models Analysis|||ΔTi/Ttot||0.036|-0.004|0.113
74062575|NCT02533505|147677313|SUPERIORITY||Mean Difference (Final Values)|57.624|||<|0.001|TWO_SIDED|95.0|29.701|85.546|||Mixed Models Analysis|||ΔVt||85.546|29.701|<0.001
74062576|NCT02533505|147677314|SUPERIORITY||Mean Difference (Final Values)|862.157|||<|0.001|TWO_SIDED|95.0|439.817|1284.496|||Mixed Models Analysis|||ΔVe||1284.496|439.817|<0.001
74062577|NCT02533505|147677315|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.007|TWO_SIDED|95.0|0.005|0.033|||Mixed Models Analysis|||ΔFEV1/FVC||0.033|0.005|0.007
74062578|NCT00883740|147677328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.15|||<|0.0001|TWO_SIDED|95.0|-26.69|-11.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-11.61|-26.69|<0.0001
74062579|NCT00883740|147677329|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.54|||<|0.0001|TWO_SIDED|95.0|-23.29|-11.8||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-11.80|-23.29|<0.0001
74062580|NCT00883740|147677330|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81||||0.3841|TWO_SIDED|95.0|-5.92|2.3||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||2.30|-5.92|0.3841
74062581|NCT00883740|147677331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.54|||<|0.0001|TWO_SIDED|95.0|17.48|33.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||33.61|17.48|<0.0001
74062582|NCT00883740|147677332|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.42|||<|0.0001|TWO_SIDED|95.0|3.74|7.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||7.11|3.74|<0.0001
74062583|NCT00883740|147677333|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.41||||0.0135|TWO_SIDED|95.0|-4.31|-0.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.51|-4.31|0.0135
74062584|NCT00883740|147677334|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.53||||0.0008|TWO_SIDED|95.0|-2.41|-0.66||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.66|-2.41|0.0008
74062585|NCT00883740|147677335|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.18||||0.0447|TWO_SIDED|95.0|-14.18|-0.17||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.17|-14.18|0.0447
74062586|NCT00883740|147677336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||0.3613|TWO_SIDED|95.0|-1.07|0.39||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 1||0.39|-1.07|0.3613
74062587|NCT00883740|147677336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0686|TWO_SIDED|95.0|-2.29|0.09||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 2||0.09|-2.29|0.0686
74062588|NCT00883740|147677336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.44||||0.0009|TWO_SIDED|95.0|-3.85|-1.03||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 3||-1.03|-3.85|0.0009
74062589|NCT00883740|147677336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.52||||0.0002|TWO_SIDED|95.0|-5.33|-1.71||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 4||-1.71|-5.33|0.0002
74062590|NCT00883740|147677336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01||||0.0065|TWO_SIDED|95.0|-5.16|-0.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 5||-0.86|-5.16|0.0065
74062591|NCT00883740|147677336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.89||||0.0024|TWO_SIDED|95.0|-6.36|-1.41||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 6||-1.41|-6.36|0.0024
73882579|NCT03224130|147299144|SUPERIORITY|||||||0.5|||||||Regression, Logistic|||||||0.50
73882580|NCT03224130|147299145|SUPERIORITY|||||||0.998|||||||Regression, Logistic|||||||0.998
74062592|NCT00883740|147677336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.59||||0.0366|TWO_SIDED|95.0|-5.01|-0.16||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 7||-0.16|-5.01|0.0366
74062593|NCT00883740|147677336|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85||||0.0593|TWO_SIDED|95.0|-5.82|0.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 8||0.11|-5.82|0.0593
74062594|NCT00883740|147677337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25||||0.1106|TWO_SIDED|95.0|-2.79|0.29||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 1||0.29|-2.79|0.1106
74062595|NCT00883740|147677337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.0|||<|0.0001|TWO_SIDED|95.0|-8.49|-3.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 2||-3.51|-8.49|<0.0001
73882581|NCT03224130|147299146|SUPERIORITY|||||||0.92|||||||Regression, Logistic|||||||0.92
73882582|NCT03287791|147299149|SUPERIORITY||Mean Difference (Final Values)|-11.27|||<|0.0001|TWO_SIDED|95.0|-16.8|-5.73|||ANOVA|||Analyses was performed using an Analysis of Variance (ANOVA) model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.||-5.73|-16.80|<.0001
73882583|NCT03287791|147299149|SUPERIORITY||Median Difference (Final Values)|-9.71||||0.0007|TWO_SIDED|95.0|-15.28|-4.14|||ANOVA|||Analyses was performed using an ANOVA model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.||-4.14|-15.28|0.0007
74062596|NCT00883740|147677337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.83||||0.0004|TWO_SIDED|95.0|-10.53|-3.13||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 3||-3.13|-10.53|0.0004
74062597|NCT00883740|147677337|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.44||||0.0199|TWO_SIDED|95.0|-10.0|-0.88||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 4||-0.88|-10.00|0.0199
74062598|NCT00883740|147677338|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.14||||0.0024|TWO_SIDED|95.0|0.78|3.5||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||3.50|0.78|0.0024
74062599|NCT00883740|147677339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.13||||0.0591|TWO_SIDED|95.0|-16.59|0.32||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5||0.32|-16.59|0.0591
73882584|NCT04673214|147299168|SUPERIORITY|The null hypothesis for the modification in the clinical evolution of the conjunctivitis sign in patients diagnosed with COVID-19 under early intervention treatment with Azithromycin / Ribaroxaban / Paracetamol for 14 days followed by video call is rejected.||||||0.05||||||Presence of a p \<0.05 as significant in the comparison of treatment with clinical symptoms|Chi-squared|||Null Hypothesis: There will be no modification in the clinical evolution ≥ 25% of patients diagnosed with COVID-19 under an early intervention treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol for 14 days followed by video call from U.M.F 13 and U.M.F 20 from I.M.S.S., during the period of December 2020- February 2021, with a power of 90%, type I error rate 1% and loss to follow-up 20%.||||0.05
73888257|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.66|||<|0.0001|TWO_SIDED|95.0|-45.02|-38.29|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-38.29|-45.02|<0.0001
74062600|NCT00883740|147677339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.81|||<|0.0001|TWO_SIDED|95.0|-27.43|-10.2||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11||-10.20|-27.43|<0.0001
73882585|NCT04673214|147299168|SUPERIORITY|The null hypothesis is rejected with a difference of 2 days in the modification of the clinical evolution (symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID -19 in early intervention treatment. vs. therapeutic failure, for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of 20%||||||0.05|||||||t-test, 2 sided|||Assuming a difference of 2 days in the modification of the clinical course (symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID-19 in early intervention treatment vs. therapeutic failure, for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of the twenty%||||0.05
73888258|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.63|||<|0.0001|TWO_SIDED|95.0|-23.01|-16.25|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-16.25|-23.01|<0.0001
73888259|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.28|||<|0.0001|TWO_SIDED|95.0|-25.67|-18.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-18.90|-25.67|<0.0001
74062601|NCT00883740|147677340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.47||||0.1101|TWO_SIDED|95.0|-12.2|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5||1.26|-12.20|0.1101
74062602|NCT00883740|147677340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.39||||0.0002|TWO_SIDED|95.0|-20.36|-6.42||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11||-6.42|-20.36|0.0002
74062603|NCT00883740|147677341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||1.24|0.58|<0.0001
74062604|NCT00883740|147677341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14|||<|0.0001|TWO_SIDED|95.0|0.76|1.53||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||1.53|0.76|<0.0001
74062605|NCT00883740|147677341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.46|1.28||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||1.28|0.46|<0.0001
74062606|NCT00883740|147677341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|||<|0.0001|TWO_SIDED|95.0|0.51|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||1.26|0.51|<0.0001
74062607|NCT00883740|147677342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.66||||0.0001|TWO_SIDED|95.0|-11.44|-3.89||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-3.89|-11.44|0.0001
74062608|NCT00883740|147677342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.67||||0.0077|TWO_SIDED|95.0|-13.27|-2.07||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-2.07|-13.27|0.0077
74062609|NCT00883740|147677342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.68||||0.2196|TWO_SIDED|95.0|-14.81|3.44||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||3.44|-14.81|0.2196
74062610|NCT00883740|147677342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.18||||0.0081|TWO_SIDED|95.0|-10.73|-1.64||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-1.64|-10.73|0.0081
74062611|NCT00883740|147677343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-1.02|-0.37||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-0.37|-1.02|<0.0001
74062612|NCT00883740|147677343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.0001|TWO_SIDED|95.0|-1.06|-0.36||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-0.36|-1.06|0.0001
74062613|NCT00883740|147677343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.0014|TWO_SIDED|95.0|-0.95|-0.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||-0.24|-0.95|0.0014
74062614|NCT00883740|147677343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52||||0.0084|TWO_SIDED|95.0|-0.9|-0.14||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-0.14|-0.90|0.0084
74062615|NCT00883740|147677344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.0001|TWO_SIDED|95.0|-27.02|-9.52||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-9.52|-27.02|<0.0001
74062616|NCT00883740|147677344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.06||||0.0002|TWO_SIDED|95.0|-24.24|-7.87||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-7.87|-24.24|0.0002
74062617|NCT00883740|147677344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.23||||0.0085|TWO_SIDED|95.0|-23.01|-3.46||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||-3.46|-23.01|0.0085
74062618|NCT00883740|147677344|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.25||||0.0102|TWO_SIDED|95.0|-18.01|-2.48||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-2.48|-18.01|0.0102
74062619|NCT00883740|147677345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.82|||<|0.0001|TWO_SIDED|95.0|13.25|36.4||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||36.40|13.25|<0.0001
74062620|NCT00883740|147677345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.4|||<|0.0001|TWO_SIDED|95.0|18.59|40.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||40.21|18.59|<0.0001
74062621|NCT00883740|147677345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.79|||<|0.0001|TWO_SIDED|95.0|15.37|38.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||38.21|15.37|<0.0001
74062622|NCT00883740|147677345|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.44|||<|0.0001|TWO_SIDED|95.0|15.03|35.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||35.86|15.03|<0.0001
74062623|NCT04936334|147677387|SUPERIORITY||McNemar|0.03|||<|0.05|TWO_SIDED||||||McNemar|||||||<0.05
74062624|NCT03583931|147677411|SUPERIORITY|||||||0.61|||||||ANOVA|||||||0.61
73888260|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.5|||<|0.0001|TWO_SIDED|95.0|-15.86|-9.14|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.14|-15.86|<0.0001
73888261|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.59|||<|0.0001|TWO_SIDED|95.0|-23.98|-17.21|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-17.21|-23.98|<0.0001
74062625|NCT03583931|147677412|SUPERIORITY|||||||0.84|||||||ANOVA|||||||0.84
74062626|NCT03583931|147677417|SUPERIORITY|||||||0.48|||||||ANOVA|||||||0.48
74062627|NCT03583931|147677418|SUPERIORITY|||||||0.25|||||||ANOVA|||||||0.25
74062628|NCT03583931|147677419|SUPERIORITY|||||||0.45|||||||ANOVA|||||||0.45
74062629|NCT03583931|147677420|SUPERIORITY|||||||0.87|||||||ANOVA|||||||0.87
74062630|NCT00535301|147677440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24|STANDARD_DEVIATION|2.0||0.005|TWO_SIDED|95.0|0.1|0.6|||Chi-squared|||Sample size was calculated based on previously-published anatomic success rates of standard anterior colporrhaphy (50%) and polypropylene mesh-reinforced anterior vaginal repair (85%) (1-10). Assuming a 2-sided hypothesis test with 5% type I error and 80% power, 33 patients in each group would be required to detect an absolute difference of 35% or more in recurrent stage II prolapse. Assuming a 15% drop-out rate, we sought to enroll 76 patients into the clinical trial.||0.6|0.1|0.005
74062631|NCT00535301|147677441|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5
74062632|NCT00535301|147677442|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
74062633|NCT05144477|147677458|OTHER|Proportion of referrals who provided consent and enrolled into the study was calculated.|Proportion|0.64|||||TWO_SIDED|95.0|0.425|0.82||||||||0.820|0.425|
73888262|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|10.64|||<|0.0001|TWO_SIDED|95.0|5.75|15.54|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.54|5.75|<0.0001
74062634|NCT05144477|147677459|OTHER|Proportion of enrolled participants who remained in the study at 30 days after the end of hospital care was calculated.|Proportion|0.875|||||TWO_SIDED|95.0|0.617|0.985||||||||0.985|0.617|
74062635|NCT05144477|147677460|OTHER|Proportion of participants randomized to the FAID Fear Diary Intervention who wrote in the diary at least twice per week up until the end of hospital care was calculated.|Proportion|0.636|||||TWO_SIDED|95.0|0.308|0.891||||||||0.891|0.308|
74062636|NCT05144477|147677461|OTHER|Proportion of enrolled participants who provided complete data for at least 90% of all study assessments was calculated.|Proportion|0.875|||||TWO_SIDED|95.0|0.617|0.985||||||||0.985|0.617|
74062637|NCT05144477|147677462|OTHER|Proportion of intervention participants who agreed that the ICU diary was acceptable for reducing fear about their loved one's heart was calculated.|Proportion|0.8|||||TWO_SIDED|95.0|0.444|0.975||||||||0.975|0.444|
74062638|NCT05144477|147677463|OTHER|Proportion of intervention participants who agreed that the ICU diary was feasible for reducing fear about their loved one's heart was calculated.|Proportion|0.9|||||TWO_SIDED|95.0|0.555|0.998||||||||0.998|0.555|
74062639|NCT05144477|147677464|OTHER|Proportion of intervention participants who agreed that the ICU diary was appropriate for reducing fear about their loved one's heart was calculated.|Proportion|0.7|||||TWO_SIDED|95.0|0.348|0.933||||||||0.933|0.348|
74062640|NCT05144477|147677465|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.63|TWO_SIDED|95.0|-0.83|1.32|||t-test, 2 sided|||Outcome analysis at the end of hospital care.||1.32|-0.83|.63
74062641|NCT05144477|147677465|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.86|TWO_SIDED|95.0|-0.92|1.08|||t-test, 2 sided|||Outcome analysis for 30 days after the end of hospital care.||1.08|-0.92|.86
74062642|NCT05144477|147677466|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.86|TWO_SIDED|95.0|-1.43|1.21|||t-test, 2 sided|||Outcome analysis for the end of hospital care.||1.21|-1.43|.86
74062643|NCT05144477|147677466|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.75|TWO_SIDED|95.0|-1.1|1.58|||t-test, 2 sided|||Outcome analysis for 30 days after the end of hospital care.||1.58|-1.10|.75
74062644|NCT05144477|147677467|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.22|TWO_SIDED|95.0|-23.26|5.86|||t-test, 2 sided|||||5.86|-23.26|.22
74062645|NCT05144477|147677467|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)||||χ2(1) = 1.29|||.26
74062646|NCT05144477|147677467|SUPERIORITY|||||||1|||||||Fisher Exact|||A Fisher's Exact Test was conducted to compare the number of participants with a positive screen for PTSD symptoms (score \>=33) to those who did not have a positive screen for PTSD symptoms (score \< 33).||||1.00
74062647|NCT04333199|147677468|SUPERIORITY||Odds Ratio (OR)|2.9903891|||<|0.001|TWO_SIDED|95.0|2.2805876|3.9211066||We used an a priori threshold of p \< .05.|Regression, Logistic|||||3.9211066|2.2805876|<0.001
74062648|NCT04333199|147677469|SUPERIORITY||Odds Ratio (OR)|1.1781659||||0.154|TWO_SIDED|95.0|0.9404654|1.4759445||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.4759445|0.9404654|0.154
74062649|NCT04333199|147677470|SUPERIORITY||Odds Ratio (OR)|0.9575636||||0.571|TWO_SIDED|95.0|0.8242111|1.1124918||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.1124918|0.8242111|0.571
74062650|NCT04333199|147677471|SUPERIORITY||Odds Ratio (OR)|1.8562672|||<|0.001|TWO_SIDED|95.0|1.5692523|2.1957769||We used an a priori threshold of p \< .05.|Regression, Logistic|||||2.1957769|1.5692523|<0.001
74062651|NCT04333199|147677473|SUPERIORITY||Odds Ratio (OR)|1.8542767|||<|0.001|TWO_SIDED|95.0|1.5220654|2.2589975||We used an a priori threshold of p \< .05.|Regression, Logistic|||||2.2589975|1.5220654|<0.001
74062652|NCT03111407|147677474|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.2342|||||||t-test, 2 sided|||"Hip Knee Angle value 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper)~iAssist group: 179.9 +/-2.9 (44) (171, 185.3)~Conventional group: 178.9 +/-3.9 (26) (167, 185)"||||0.2342
73882586|NCT04673214|147299169|SUPERIORITY|Assuming a difference in the percentage of effectiveness in the clinical modification and therapeutic failure of patients diagnosed with the outcome of improvement in the Modification of the clinical evolution of the symptoms of patients with COVID-19 using double therapy was reported 95.7% (n = 44) Vs. triple therapy 90.8% (n = 59) and therapeutic failure 4.3% (n = 2) vs. 9.2% (n = 6), respectively.||||||0.05||||||Presence of a p \<0.05 as significant in the comparison of treatment with clinical symptoms the clinical modification and therapeutic failure of patients diagnosed with COVID-19|Chi-squared|||Assuming a difference in the percentage of effectiveness in the clinical modification and therapeutic failure of patients diagnosed with COVID-19 under treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of 20%||||0.05
73882587|NCT04673214|147299170|SUPERIORITY|The null hypothesis is rejected with a mean duration of 2 days with clinical symptoms of COVID-19 in early intervention treatment as a result of improving the modification of the clinical evolution of symptoms vs therapeutic failure.||||||0.05|||||||t-test, 2 sided|||Assuming a difference in days of effectiveness in clinical modification and therapeutic failure of patients diagnosed with COVID-19 in treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a potency 90%, a Type I error rate of 1%, and a loss to follow-up of 20%||||0.05
73888263|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.74|||<|0.0001|TWO_SIDED|95.0|-62.63|-52.85|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-52.85|-62.63|<0.0001
74062653|NCT03111407|147677475|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.4427|||||||t-test, 2 sided|||"Knee Society Score Assessment 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper)~iAssist group: 74.7 +/- 12.5 \[44\] (30.2, 78.0, 89.5), 95% C.I. (70.9, 78.5)~Conventional group: 72.4 +/- 11.6 \[26\] (45.0, 75.2, 90.1), 95% C.I. (67.7, 77.1)"||||0.4427
74062654|NCT03111407|147677476|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.6154|||||||t-test, 2 sided|||Knee Soceity Score Function 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper) iAssist group: 80.5 +/- 13.8 \[44\] (55.0, 80.0, 100.0), 95% C.I. (76.2, 84.7) Conventional group: 78.5 +/- 19.1 \[26\] (40.0, 80.0, 100.0),95% C.I. (70.8, 86.2)||||0.6154
74062655|NCT03111407|147677477|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.4549|||||||t-test, 2 sided|||EQ-5D score 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper) iAssist group: 0.8 +/- 0.2 \[29\] (0.0, 1.0, 1.0), 95% C.I. (0.7, 0.9) Conventional group: 0.8 +/- 0.3 \[20\] (0.1, 0.8, 1.0), 95% C.I. (0.7, 0.9)||||0.4549
74062656|NCT01032330|147677611|SUPERIORITY||Risk Difference (RD)|0.054||||0.004|ONE_SIDED|95.0|0.02||||One-sided Barnard's Test||||||0.020|0.004
74062657|NCT01032330|147677612|OTHER||cumulative probability|0.15|||||TWO_SIDED|95.0|0.1|0.22|||||Kaplan-Meier estimate of cumulative probability of deterioration by 3 years|||.22|.10|
74062658|NCT01032330|147677613|SUPERIORITY||Risk Difference (RD)|0.024||||0.27|TWO_SIDED|95.0|-0.038|0.094|||One-sided Barnard's Test|||||0.094|-0.038|0.27
74062659|NCT01032330|147677615|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
74062660|NCT01032330|147677616|OTHER|||||||0.38|||||||ANCOVA|||Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome; P values for comparisons of binary outcomes are from logistic regression models adjusting for the baseline level of the outcome.||||0.38
74062661|NCT01032330|147677617|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
74062662|NCT01032330|147677618|OTHER|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.09
74062663|NCT01032330|147677618|OTHER|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.02
74062664|NCT01032330|147677619|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
74062665|NCT01032330|147677619|OTHER|||||||0.33|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.33
74062666|NCT01032330|147677620|OTHER|||||||0.013|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.013
74062667|NCT01032330|147677620|OTHER|||||||0.26|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.26
74062668|NCT01032330|147677621|OTHER|||||||0.42|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.42
74062669|NCT01032330|147677621|OTHER|||||||0.61|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.61
74062670|NCT01032330|147677622|OTHER|||||||0.012|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.012
74062671|NCT01032330|147677622|OTHER|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.02
74062672|NCT01032330|147677623|OTHER|||||||0.002|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||.002
74062673|NCT01032330|147677623|OTHER|||||||0.01|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.01
74062674|NCT01032330|147677624|OTHER|||||||0.11|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.11
74062675|NCT01032330|147677624|OTHER|||||||0.1|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.10
74062676|NCT01032330|147677625|OTHER|||||||0.6|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.60
74062677|NCT01032330|147677625|OTHER|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.09
74062678|NCT01155284|147677626|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|||||The p value between treatment groups of C-peptide log (AUC+1) with covariate analysis adjusted for age, sex, baseline C-peptide concentration and duration of diabetes.|ANCOVA|||||||0.81
73888264|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.18|||<|0.0001|TWO_SIDED|95.0|-27.09|-17.27|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-17.27|-27.09|<0.0001
74062679|NCT01155284|147677627|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED||||||ANCOVA|||||||0.869
74062680|NCT02618772|147677628|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||||||0.026
74062681|NCT02618772|147677629|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
74062682|NCT02618772|147677630|SUPERIORITY_OR_OTHER|||||||0.151||||||This is in reference to the baseline measure.|t-test, 2 sided|||||||0.151
74062683|NCT02618772|147677630|SUPERIORITY_OR_OTHER|||||||0.02||||||This is in reference to the intervention measure.|t-test, 2 sided|||||||0.020
74062684|NCT02618772|147677630|SUPERIORITY_OR_OTHER|||||||0.198||||||This is in reference to the lidocaine measure.|t-test, 2 sided|||||||0.198
74062685|NCT02618772|147677630|SUPERIORITY_OR_OTHER|||||||0.006||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided|||||||0.006
74062686|NCT02618772|147677631|SUPERIORITY_OR_OTHER|||||||0.185||||||This is in reference to the baseline measure.|t-test, 2 sided|||||||0.185
74062687|NCT02618772|147677631|SUPERIORITY_OR_OTHER|||||||0.011||||||This is in reference to the intervention measure.|t-test, 2 sided|||||||0.011
74062688|NCT02618772|147677631|SUPERIORITY_OR_OTHER|||||||0.191||||||This is in reference to the lidocaine measure.|t-test, 2 sided|||||||0.191
74062689|NCT02618772|147677631|SUPERIORITY_OR_OTHER|||||||0.008||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided|||||||0.008
74062690|NCT02618772|147677632|SUPERIORITY_OR_OTHER|||||||0.004||||||This p value is a t-test of the Post STAI minus Pre STAI variable.|t-test, 2 sided|||||||0.004
74062691|NCT02618772|147677633|SUPERIORITY_OR_OTHER|||||||0.015||||||This p value is in reference to the t-test performed for STAI Post Minus STAI Pre.|t-test, 2 sided|||||||0.015
74062692|NCT02618772|147677634|SUPERIORITY_OR_OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.080
74062693|NCT02618772|147677635|SUPERIORITY_OR_OTHER|||||||0.086|||||||t-test, 2 sided|||||||0.086
74062694|NCT02618772|147677636|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74062695|NCT02618772|147677637|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74062696|NCT02328404|147677642|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|Fisher Exact test was used||The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value\</= 0.05)||||0.001
74062697|NCT02328404|147677643|SUPERIORITY_OR_OTHER||||||<|0||||||A P-value \< 0.05 would be considered statistically significant.|t-test, 2 sided|||Both arms where evaluated at which paired t-test for the mean difference in the two arm was calculated . where the serum 25-OH Vit D3 was measured at 0 day time and after the end of the study. after that a paired t-test where applied for the difference for the 25-OH VitD3 levels between the two time points||||<0.000
74062698|NCT02328404|147677644|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||t-test, 2 sided|||||||0.67
74062699|NCT02328404|147677645|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||||||0.51
73888265|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.91|||<|0.0001|TWO_SIDED|95.0|-29.83|-20.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-20.00|-29.83|<0.0001
74062700|NCT02328404|147677646|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
74062701|NCT02328404|147677647|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
74062702|NCT02328404|147677648|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
74062703|NCT02328404|147677649|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
74062704|NCT02328404|147677650|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
74062705|NCT02328404|147677651|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
74062706|NCT02328404|147677652|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||t-test, 2 sided|||||||0.35
74062707|NCT02328404|147677653|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
74062708|NCT02328404|147677654|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
74062709|NCT02328404|147677655|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
74062710|NCT02328404|147677656|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
74062711|NCT01289990|147677660|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.94|-0.64||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.64|-0.94|<0.0001
74062712|NCT01289990|147677660|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.06|-0.76||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.76|-1.06|<0.0001
74062713|NCT01289990|147677660|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.82|-0.52||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.52|-0.82|<0.0001
74062714|NCT01289990|147677660|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.1245|TWO_SIDED|95.0|-0.27|0.03||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||0.03|-0.27|0.1245
74062715|NCT01289990|147677660|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.0022|TWO_SIDED|95.0|-0.39|-0.09||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.09|-0.39|0.0022
74062716|NCT01289990|147677660|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.79|-0.41||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.41|-0.79|<0.0001
74062717|NCT01289990|147677660|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.87|-0.49||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.49|-0.87|<0.0001
74062718|NCT01289990|147677660|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.75|-0.48||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.48|-0.75|<0.0001
73888266|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.53|||<|0.0001|TWO_SIDED|95.0|-18.41|-8.64|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-8.64|-18.41|<0.0001
74062719|NCT01289990|147677660|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.83|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.55|-0.83|<0.0001
74062720|NCT01289990|147677660|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.89|-0.59||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.59|-0.89|<0.0001
74062721|NCT01289990|147677660|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.55|-0.85|<0.0001
74062722|NCT01289990|147677661|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.04|-0.61||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.61|-1.04|<0.0001
73882588|NCT04673214|147299171|SUPERIORITY|A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.||||||0.05|||||||Wilcoxon (Gehan) statistical test|||Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%||||0.05
73882589|NCT03562195|147299188|SUPERIORITY||Posterior probablity|0.9999|||||||||||Bayesian Dynamic Borrowing|A BDB approach was used in the estimation of primary endpoint in the Chinese participants of this study, with information borrowed from MEA115588.|"Pr (rate ratio \<1 \| data)\>0.999. The 'positive result' is defined as if the posterior probability that the rate ratio is less than 1 is at least 0.95"|||||
73882590|NCT03562195|147299188|SUPERIORITY|The null hypothesis is defined as the rate ratio of events between Mepolizumab 100mg SC versus placebo is less than 1.|Rate Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.24|0.5|||Negative binomial model|||||0.50|0.24|<0.001
73882591|NCT04664153|147299210|SUPERIORITY||Mean Difference (Final Values)|-39.4|STANDARD_ERROR_OF_MEAN|11.74||0.0004|TWO_SIDED|90.0|-58.76|-20.12|||t-test, 1 sided|||||-20.12|-58.76|0.0004
73882592|NCT04664153|147299211|SUPERIORITY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|90.0|-7.02|-2.77|||t-test, 1 sided|||||-2.77|-7.02|<0.0001
73882593|NCT00097500|147299229|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
73882594|NCT00097500|147299230|SUPERIORITY_OR_OTHER|||||||0.4185||95.0|||||ANCOVA|||||||0.4185
73882595|NCT00097500|147299231|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical analysis at week 52.||||<0.0001
73882596|NCT00097500|147299231|SUPERIORITY_OR_OTHER|||||||0.1188||95.0|||||ANCOVA|||Statistical analysis at week 56.||||0.1188
74062723|NCT01289990|147677661|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.11|-0.69||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.69|-1.11|<0.0001
74062724|NCT01289990|147677661|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.0322|TWO_SIDED|95.0|-0.41|-0.02||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.02|-0.41|0.0322
74062725|NCT01289990|147677661|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0038|TWO_SIDED|95.0|-0.48|-0.09||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.09|-0.48|0.0038
74062726|NCT01289990|147677661|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.83|-0.4||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.40|-0.83|<0.0001
74062727|NCT01289990|147677661|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.9|-0.33||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.33|-0.90|<0.0001
74062728|NCT01289990|147677661|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.0|-0.44||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.44|-1.00|<0.0001
74062729|NCT01289990|147677661|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.87|-0.47||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.47|-0.87|<0.0001
74062730|NCT01289990|147677661|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-1.04|-0.63||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.63|-1.04|<0.0001
74062731|NCT01289990|147677661|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.57||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.57|-1.04|<0.0001
74062732|NCT01289990|147677661|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.56||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.56|-1.04|<0.0001
74062733|NCT01289990|147677662|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.8|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.5|-6.8|<0.0001
74062734|NCT01289990|147677662|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.1||0.0001|TWO_SIDED|95.0|-6.4|-2.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.1|-6.4|0.0001
74062735|NCT01289990|147677662|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1||0.2107|TWO_SIDED|95.0|-3.5|0.8||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.8|-3.5|0.2107
74062736|NCT01289990|147677662|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.1||0.0033|TWO_SIDED|95.0|-5.4|-1.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.1|-5.4|0.0033
73882597|NCT00097500|147299232|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical analysis at week 52.||||<0.0001
73882598|NCT00097500|147299232|SUPERIORITY_OR_OTHER|||||||0.1996||95.0|||||ANCOVA|||Statistical analysis at week 56.||||0.1996
74062737|NCT01289990|147677662|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.1||0.0105|TWO_SIDED|95.0|-5.0|-0.7||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-5.0|0.0105
74062738|NCT01289990|147677662|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|1.3||0.0543|TWO_SIDED|95.0|-4.9|0.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.0|-4.9|0.0543
73882599|NCT00097500|147299233|SUPERIORITY_OR_OTHER|||||||0.5522||95.0|||||ANCOVA|||||||0.5522
73882600|NCT00097500|147299234|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
73882601|NCT00097500|147299236|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
73882602|NCT00189098|147299254|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-25.0|||||TWO_SIDED|95.0|-44.0|-6.0|||risk differences (RD)||Risk difference and 95% confidence intervals reported for 6 weeks follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||-6|-44|
73882603|NCT00189098|147299254|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.0|||||TWO_SIDED|95.0|-34.0|4.0|||risk difference (RD)||Risk difference and confidence interval reported for 12 week follow-up|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||4|-34|
74062739|NCT01289990|147677662|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.9|STANDARD_ERROR_OF_MEAN|1.2||0.0019|TWO_SIDED|95.0|-6.4|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.5|-6.4|0.0019
74062740|NCT01289990|147677662|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.0||0.0045|TWO_SIDED|95.0|-5.0|-0.9||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.9|-5.0|0.0045
74062741|NCT01289990|147677662|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-6.6|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.5|-6.6|<0.0001
74062742|NCT01289990|147677662|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.0||0.0031|TWO_SIDED|95.0|-4.8|-1.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-4.8|0.0031
74062743|NCT01289990|147677662|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.0||0.0096|TWO_SIDED|95.0|-4.4|-0.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-4.4|0.0096
74062744|NCT01289990|147677663|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.94|-0.63||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.63|-0.94|<0.0001
74062745|NCT01289990|147677663|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.04|-0.73||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.73|-1.04|<0.0001
74062746|NCT01289990|147677663|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.82|-0.51||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.51|-0.82|<0.0001
74062747|NCT01289990|147677663|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.131|TWO_SIDED|95.0|-0.28|0.04||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||0.04|-0.28|0.1310
74062748|NCT01289990|147677663|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.005|TWO_SIDED|95.0|-0.38|-0.07||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.07|-0.38|0.0050
74062749|NCT01289990|147677663|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.79|-0.4||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.40|-0.79|<0.0001
74062750|NCT01289990|147677663|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.88|-0.5||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.50|-0.88|<0.0001
74062751|NCT01289990|147677663|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.75|-0.46||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.46|-0.75|<0.0001
74062752|NCT01289990|147677663|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.88|-0.58||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.58|-0.88|<0.0001
73888267|NCT01746901|147309545|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.7|||<|0.0001|TWO_SIDED|95.0|-28.62|-18.78|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-18.78|-28.62|<0.0001
74062753|NCT01289990|147677663|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.87|-0.56|||ANCOVA|||||-0.56|-0.87|<0.0001
74062754|NCT01289990|147677663|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.53||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.53|-0.85|<0.0001
74062755|NCT01289990|147677664|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0025|TWO_SIDED|95.0|-5.5|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-5.5|0.0025
74062756|NCT01289990|147677664|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0021|TWO_SIDED|95.0|-5.6|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-5.6|0.0021
73882604|NCT00189098|147299254|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-12.0|22.0|||risk difference (RD)||Risk difference and confidence interval reported for 1 year follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||22|-12|
73882605|NCT00189098|147299255|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-34.0|10.0|||rate differences (95%CI intervals)||Risk difference and confidence interval reported for eardrop usage between 6 and 12 weeks follow-up.|||10|-34|
73882606|NCT00189098|147299256|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-22.0|14.0|||rate difference (RD)||Risk difference and confidence interval reported for eardrop usage between 12 weeks and 1 year follow-up.|||14|-22|
73882607|NCT00189098|147299257|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.0|||||TWO_SIDED|95.0|-23.0|9.0|||Rate differences (95%CI interval)||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 6 to 12 weeks follow-up.|||9|-23|
73882608|NCT00189098|147299258|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.0|||||TWO_SIDED|95.0|-7.0|37.0|||Rate difference (RD)||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 12 weeks and 1 year follow-up.|||37|-7|
74062757|NCT01289990|147677664|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|1.1||0.7241|TWO_SIDED|95.0|-1.8|2.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||2.6|-1.8|0.7241
74062758|NCT01289990|147677664|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0008|TWO_SIDED|95.0|-5.9|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.6|-5.9|0.0008
74062759|NCT01289990|147677664|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.8|STANDARD_ERROR_OF_MEAN|1.1||0.0007|TWO_SIDED|95.0|-6.0|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.6|-6.0|0.0007
74062760|NCT01289990|147677664|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.2||0.0987|TWO_SIDED|95.0|-4.5|0.4||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-4.5|0.0987
74062761|NCT01289990|147677664|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.2||0.0028|TWO_SIDED|95.0|-6.1|-1.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.3|-6.1|0.0028
74062762|NCT01289990|147677664|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.6|-2.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.3|-6.6|<0.0001
74062763|NCT01289990|147677664|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0008|TWO_SIDED|95.0|-5.9|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.5|-5.9|0.0008
74062764|NCT01289990|147677664|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|1.0||0.0213|TWO_SIDED|95.0|-4.1|-0.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-4.1|0.0213
74062765|NCT01289990|147677664|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.0||0.0288|TWO_SIDED|95.0|-4.1|-0.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-4.1|0.0288
74062766|NCT01289990|147677665|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.1058|TWO_SIDED|95.0|-2.4|0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.2|-2.4|0.1058
74062767|NCT01289990|147677665|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0109|TWO_SIDED|95.0|-3.1|-0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-3.1|0.0109
74062768|NCT01289990|147677665|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.8259|TWO_SIDED|95.0|-1.5|1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.2|-1.5|0.8259
74062769|NCT01289990|147677665|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.7||0.166|TWO_SIDED|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.3|0.1660
74062770|NCT01289990|147677665|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.7||0.0212|TWO_SIDED|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.9|0.0212
74062771|NCT01289990|147677665|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0076|TWO_SIDED|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-3.4|0.0076
74062772|NCT01289990|147677665|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.7||0.0003|TWO_SIDED|95.0|-4.1|-1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-4.1|0.0003
74062773|NCT01289990|147677665|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.7||0.017|TWO_SIDED|95.0|-3.2|-0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-3.2|0.0170
73882609|NCT00189098|147299259|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|-12.0|24.0|||Rate differences (95%CI intervals)||Risk difference and confidence interval reported for participants who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.|||24|-12|
73882610|NCT00474123|147299260|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Wilcoxon (Mann-Whitney)|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.3
73882611|NCT00474123|147299261|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.65
73882612|NCT00474123|147299262|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.02
74062774|NCT01289990|147677665|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0236|TWO_SIDED|95.0|-3.1|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-3.1|0.0236
73882613|NCT00474123|147299263|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.85
73882614|NCT01009060|147299272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.049||||0.7239|TWO_SIDED|90.0|-0.288|0.19|||Mixed Model Repeated Measure|||Week 1||0.190|-0.288|0.7239
73882615|NCT01009060|147299272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.018||||0.8351|TWO_SIDED|90.0|-0.127|0.163|||Mixed Model Repeated Measure|||Week 2||0.163|-0.127|0.8351
73882616|NCT01009060|147299272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.088||||0.4541|TWO_SIDED|90.0|-0.287|0.11|||Mixed Model Repeated Measure|||Week 3||0.110|-0.287|0.4541
74062775|NCT01289990|147677665|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2523|TWO_SIDED|95.0|-2.0|0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.5|-2.0|0.2523
74062776|NCT01289990|147677665|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.3494|TWO_SIDED|95.0|-1.9|0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.7|-1.9|0.3494
74062777|NCT01289990|147677666|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1568|TWO_SIDED|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.3|0.1568
74062778|NCT01289990|147677666|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1323|TWO_SIDED|95.0|-2.4|0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.3|-2.4|0.1323
74062779|NCT01289990|147677666|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4327|TWO_SIDED|95.0|-0.8|1.9||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.9|-0.8|0.4327
74062780|NCT01289990|147677666|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.0289|TWO_SIDED|95.0|-2.8|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.8|0.0289
74062781|NCT01289990|147677666|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.7||0.0231|TWO_SIDED|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.9|0.0231
74062782|NCT01289990|147677666|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.8||0.0513|TWO_SIDED|95.0|-3.0|0.0||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.0|-3.0|0.0513
74062783|NCT01289990|147677666|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0038|TWO_SIDED|95.0|-3.7|-0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-3.7|0.0038
74062784|NCT01289990|147677666|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0084|TWO_SIDED|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-3.4|0.0084
74062785|NCT01289990|147677666|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.7||0.0677|TWO_SIDED|95.0|-2.8|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.8|0.0677
73882617|NCT01009060|147299272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089||||0.4148|TWO_SIDED|90.0|-0.272|0.093|||Mixed Model Repeated Measure|||Week 4||0.093|-0.272|0.4148
74062786|NCT01289990|147677666|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.0814|TWO_SIDED|95.0|-2.4|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.4|0.0814
74062787|NCT01289990|147677666|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.7||0.1785|TWO_SIDED|95.0|-2.2|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.2|0.1785
74062788|NCT01289990|147677667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.22|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.75|-1.69||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.69|-2.75|<0.0001
74062789|NCT01289990|147677667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.14|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.66|-1.61||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.61|-2.66|<0.0001
74062790|NCT01289990|147677667|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.27||0.0223|TWO_SIDED|95.0|0.09|1.14||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.14|0.09|0.0223
74062791|NCT01289990|147677667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.84|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.37|-2.31||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.31|-3.37|<0.0001
74062792|NCT01289990|147677667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.75|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.28|-2.22|||ANCOVA|||||-2.22|-3.28|<0.0001
74062793|NCT01289990|147677667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.09|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.76|-1.41||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.41|-2.76|<0.0001
74062794|NCT01289990|147677667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.66|-1.32||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.32|-2.66|<0.0001
74062795|NCT01289990|147677667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.27|-1.19||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.19|-2.27|<0.0001
74062796|NCT01289990|147677667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.85|-1.76||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.76|-2.85|<0.0001
73882618|NCT01009060|147299272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086||||0.3887|TWO_SIDED|90.0|-0.082|0.254|||Mixed Model Repeated Measure|||Week 5||0.254|-0.082|0.3887
74062797|NCT01289990|147677667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.48|-1.47||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.47|-2.48|<0.0001
74062798|NCT01289990|147677667|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.01|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.52|-1.5||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.50|-2.52|<0.0001
74062799|NCT01289990|147677668|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.35|-1.26||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.26|-2.35|<0.0001
74062800|NCT01289990|147677668|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.56|-1.48||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.48|-2.56|<0.0001
74062801|NCT01289990|147677668|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.28||0.0546|TWO_SIDED|95.0|-0.01|1.08||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.08|-0.01|0.0546
74062802|NCT01289990|147677668|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.34|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.89|-1.8||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.80|-2.89|<0.0001
74062803|NCT01289990|147677668|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.56|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-3.1|-2.01||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.01|-3.10|<0.0001
74062804|NCT01289990|147677668|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.69|-1.24||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.24|-2.69|<0.0001
74062805|NCT01289990|147677668|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.43|-0.99||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.99|-2.43|<0.0001
73882619|NCT01009060|147299272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.195||||0.2594|TWO_SIDED|90.0|-0.093|0.484|||Mixed Model Repeated Measure|||Week 6||0.484|-0.093|0.2594
73882620|NCT01009060|147299272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.4778|TWO_SIDED|90.0|-0.139|0.344|||Mixed Model Repeated Measure|||Week 7||0.344|-0.139|0.4778
73882621|NCT01009060|147299273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.737||||0.6947|TWO_SIDED|90.0|-3.884|2.409|||ANCOVA|||||2.409|-3.884|0.6947
73882622|NCT01009060|147299274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.252||||0.1399|TWO_SIDED|90.0|-0.535|0.03|||Mixed Model Repeated Measure||For Speed of Processing/Simple Reaction Time|||0.030|-0.535|0.1399
73882623|NCT01009060|147299274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.179||||0.3992|TWO_SIDED|90.0|-0.176|0.534|||Mixed Model Repeated Measure||For Attention/Vigilance|||0.534|-0.176|0.3992
73882624|NCT01009060|147299274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.391||||0.1547|TWO_SIDED|90.0|-0.063|0.845|||Mixed Model Repeated Measure||For Working Memory|||0.845|-0.063|0.1547
73882625|NCT01009060|147299274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.279||||0.2531|TWO_SIDED|90.0|-0.127|0.685|||Mixed Model Repeated Measure||For Visual Learning|||0.685|-0.127|0.2531
73882626|NCT01009060|147299274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.398||||0.2417|TWO_SIDED|90.0|-0.167|0.963|||Mixed Model Repeated Measure||For Verbal Learning|||0.963|-0.167|0.2417
74062806|NCT01289990|147677668|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.93|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.52|-1.34||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.34|-2.52|<0.0001
74062807|NCT01289990|147677668|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.79|-1.6||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.60|-2.79|<0.0001
74062808|NCT01289990|147677668|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.34|-1.27||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.27|-2.34|<0.0001
73882627|NCT01009060|147299274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.177||||0.2069|TWO_SIDED|90.0|-0.055|0.409|||Mixed Model Repeated Measure||For Reasoning/Problem Solving|||0.409|-0.055|0.2069
73882628|NCT01009060|147299274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.8645|TWO_SIDED|90.0|-0.262|0.322|||Mixed Model Repeated Measure||For Social Cognition|||0.322|-0.262|0.8645
73882629|NCT01009060|147299274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069||||0.7873|TWO_SIDED|90.0|-0.364|0.503|||Mixed Model Repeated Measure||For Working Memory (Two-Back Memory)|||0.503|-0.364|0.7873
73882630|NCT01009060|147299275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.024||||0.0225|TWO_SIDED|90.0|-6.872|-1.175|||ANCOVA||For Speed of Processing|||-1.175|-6.872|0.0225
73882631|NCT01009060|147299275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.24||||0.3317|TWO_SIDED|95.0|-6.085|1.605|||ANCOVA||For Attention/Vigilance|||1.605|-6.085|0.3317
73882632|NCT01009060|147299275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.038||||0.3243|TWO_SIDED|90.0|-5.482|1.406|||ANCOVA||For Working Memory|||1.406|-5.482|0.3243
73882633|NCT01009060|147299275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.746||||0.7497|TWO_SIDED|90.0|-4.667|3.175|||ANCOVA||For Visual Learning|||3.175|-4.667|0.7497
73882634|NCT01009060|147299275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.112||||0.1585|TWO_SIDED|90.0|-0.537|6.761|||ANCOVA||For Verbal Learning|||6.761|-0.537|0.1585
73882635|NCT01009060|147299275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.972||||0.6582|TWO_SIDED|90.0|-2.709|4.654|||ANCOVA||For Reasoning and Problem Solving|||4.654|-2.709|0.6582
73882636|NCT01009060|147299275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.338||||0.9092|TWO_SIDED|90.0|-5.316|4.639|||ANCOVA||For Social Cognition|||4.639|-5.316|0.9092
73882637|NCT01009060|147299276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.024||||0.4406|TWO_SIDED|90.0|-3.237|1.19|||Mixed Model Repeated Measure|||||1.190|-3.237|0.4406
73882638|NCT01009060|147299277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.876||||0.5197|TWO_SIDED|90.0|-6.743|2.99|||Mixed Model Repeated Measure|||||2.990|-6.743|0.5197
73882639|NCT01009060|147299278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.824||||0.4637|TWO_SIDED|90.0|-2.334|5.982|||Mixed Model Repeated Measure|||||5.982|-2.334|0.4637
73882640|NCT00265564|147299287|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||We investigated treatment condition differences in change of drug and alcohol use over four time-points using generalized linear mixed modeling analyses. A trajectory for each participant was modeled yielding estimates of baseline scores (intercept), slope, and error. Four between-person parameters were estimated: average baseline score for all participants, average slope over time in TAU condition, effect of being in SS on average intercept, effect of being in SS on average slope.||||> .05
73882641|NCT00265564|147299288|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
73882642|NCT00265564|147299289|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||Generalized linear mixed modeling analysis||||>.05
73888268|NCT01746901|147309546|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73|||<|0.0001|TWO_SIDED|95.0|-11.9|-7.57|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-7.57|-11.90|<0.0001
74062809|NCT01289990|147677668|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.18|-1.11||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.11|-2.18|<0.0001
74062810|NCT01289990|147677669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.1|0.0001
74062811|NCT01289990|147677669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.5||0.0015|TWO_SIDED|95.0|-2.8|-0.7||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-2.8|0.0015
74062812|NCT01289990|147677669|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.5052|TWO_SIDED|95.0|-0.7|1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.4|-0.7|0.5052
74062813|NCT01289990|147677669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.5|-1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.4|-3.5|<0.0001
74062814|NCT01289990|147677669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.1|0.0001
74062815|NCT01289990|147677669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.5||0.0064|TWO_SIDED|95.0|-2.6|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-2.6|0.0064
74062816|NCT01289990|147677669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0642|TWO_SIDED|95.0|-2.1|0.1||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.1|0.0642
74062817|NCT01289990|147677669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.0053|TWO_SIDED|95.0|-1.8|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-1.8|0.0053
74062818|NCT01289990|147677669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||ANCOVA|||||-0.9|-2.3|<0.0001
74062819|NCT01289990|147677669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.1|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.1|0.0010
74062820|NCT01289990|147677669|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.0015|TWO_SIDED|95.0|-2.1|-0.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-2.1|0.0015
74062821|NCT01289990|147677670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5||0.0028|TWO_SIDED|95.0|-2.7|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.7|0.0028
74062822|NCT01289990|147677670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.5||0.0019|TWO_SIDED|95.0|-2.8|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.8|0.0019
74062823|NCT01289990|147677670|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.6||0.5044|TWO_SIDED|95.0|-0.7|1.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.5|-0.7|0.5044
74062824|NCT01289990|147677670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.0003|TWO_SIDED|95.0|-3.1|-0.9||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.9|-3.1|0.0003
74062825|NCT01289990|147677670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6||0.0002|TWO_SIDED|95.0|-3.2|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.2|0.0002
73882643|NCT00119847|147299295|SUPERIORITY||Mean Difference (Net)|-0.04||||0.34|TWO_SIDED|95.0|-0.12|0.04||p\<0.05 required for statistical significance|t-test, 2 sided|||The planned sample size of 300 subjects was chosen to provide 80% power to detect a clinically relevant difference of 0.1 in the change in α1 from baseline to 1 year between the 2 treatment groups on the basis of data from prior studies that indicated that baseline levels of α1 would be 1.0 with a common SD of 0.2.||0.04|-0.12|0.34
74062826|NCT01289990|147677670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.0109|TWO_SIDED|95.0|-2.5|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-2.5|0.0109
74062827|NCT01289990|147677670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.1238|TWO_SIDED|95.0|-1.9|0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.2|-1.9|0.1238
73882644|NCT00119847|147299296|SUPERIORITY||Mean Difference (Net)|3.0||||0.45|TWO_SIDED|95.0|-4.8|10.7||p\<0.01 required for statistical significance|t-test, 2 sided|||||10.7|-4.8|0.45
74062828|NCT01289990|147677670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.4|-0.8||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.8|-2.4|<0.0001
74062829|NCT01289990|147677670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.0076|TWO_SIDED|95.0|-1.9|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-1.9|0.0076
74062830|NCT01289990|147677670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0049|TWO_SIDED|95.0|-2.1|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-2.1|0.0049
74062831|NCT01289990|147677670|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.0178|TWO_SIDED|95.0|-1.9|-0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-1.9|0.0178
74062832|NCT01289990|147677671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-32.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-37.8|-26.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-26.7|-37.8|<0.0001
74062833|NCT01289990|147677671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-37.2|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-42.8|-31.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-31.7|-42.8|<0.0001
73882645|NCT00119847|147299297|SUPERIORITY||Mean Difference (Net)|2.2||||0.23|TWO_SIDED|95.0|-1.4|5.9||p\<0.01 required for statistical significance|t-test, 2 sided|||||5.9|-1.4|0.23
74062834|NCT01289990|147677671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-22.9|-11.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-11.7|-22.9|<0.0001
74062835|NCT01289990|147677671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.0|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-20.6|-9.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-9.4|-20.6|<0.0001
74062836|NCT01289990|147677671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-25.5|-14.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-14.4|-25.5|<0.0001
74062837|NCT01289990|147677671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.1|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|95.0|-35.0|-19.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.2|-35.0|<0.0001
74062838|NCT01289990|147677671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.0|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|95.0|-38.9|-23.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-23.2|-38.9|<0.0001
74062839|NCT01289990|147677671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-24.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-29.7|-18.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-18.9|-29.7|<0.0001
74062840|NCT01289990|147677671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-32.7|-21.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-21.9|-32.7|<0.0001
74062841|NCT01289990|147677671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.8|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-33.6|-22.0||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-22.0|-33.6|<0.0001
74062842|NCT01289990|147677671|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.7|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-34.5|-22.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-22.8|-34.5|<0.0001
74062843|NCT01289990|147677672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-37.4|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.9|-37.4|<0.0001
74062844|NCT01289990|147677672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-40.7|-29.1||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-29.1|-40.7|<0.0001
74062845|NCT01289990|147677672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-16.3|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-22.1|-10.5||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-10.5|-22.1|<0.0001
74062846|NCT01289990|147677672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.4|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-21.2|-9.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-9.6|-21.2|<0.0001
74062847|NCT01289990|147677672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-18.7|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-24.5|-12.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-12.8|-24.5|<0.0001
74062848|NCT01289990|147677672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.3|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-31.4|-15.3||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-15.3|-31.4|<0.0001
74062849|NCT01289990|147677672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.4|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-35.4|-19.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.4|-35.4|<0.0001
74062850|NCT01289990|147677672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.1|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-30.5|-19.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.6|-30.5|<0.0001
74062851|NCT01289990|147677672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-36.9|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.9|-36.9|<0.0001
74062852|NCT01289990|147677672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-37.0|-24.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-24.9|-37.0|<0.0001
74062853|NCT01289990|147677672|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.8|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-37.9|-25.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.7|-37.9|<0.0001
73882646|NCT04913610|147299347|OTHER||||||=|0.036|||||||Mann-Whitney U test|The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.036
73882647|NCT04913610|147299347|OTHER||||||=|0.53||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.530
74062854|NCT04529499|147677673|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
73882648|NCT04913610|147299347|OTHER||||||=|0.852||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.852
74062855|NCT04529499|147677673|SUPERIORITY||Cox Proportional Hazard|0.991|||||TWO_SIDED|95.0|0.767|1.28|||||Favipiravir + supportive care in numerator and Placebo+ Supportive care in denominator for CPH ratio analysis|||1.280|0.767|
74062856|NCT04529499|147677674|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
74062857|NCT03611751|147677706|SUPERIORITY||Odds Ratio (OR)|10.55|||<|0.0001|TWO_SIDED|95.0|6.54|17.0|||Cochran-Mantel-Haenszel|||||17.00|6.54|<0.0001
74062858|NCT03611751|147677707|SUPERIORITY||Odds Ratio (OR)|10.49|||<|0.0001|TWO_SIDED|95.0|6.65|16.55|||Cochran-Mantel-Haenszel|||||16.55|6.65|<0.0001
74062859|NCT03611751|147677708|SUPERIORITY||Odds Ratio (OR)|11.42|||<|0.0001|TWO_SIDED|95.0|5.45|23.93|||Cochran-Mantel-Haenszel|||||23.93|5.45|<0.0001
74062860|NCT03611751|147677708|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0046|TWO_SIDED|95.0|1.18|2.56|||Cochran-Mantel-Haenszel|||||2.56|1.18|0.0046
74062861|NCT03611751|147677709|SUPERIORITY||Odds Ratio (OR)|9.21|||<|0.001|TWO_SIDED|95.0|2.89|29.4|||Cochran-Mantel-Haenszel|||||29.40|2.89|<0.001
74062862|NCT03611751|147677709|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0051|TWO_SIDED|95.0|1.3|5.0|||Cochran-Mantel-Haenszel|||||5.00|1.30|0.0051
74062863|NCT03611751|147677710|SUPERIORITY||Odds Ratio (OR)|14.44|||<|0.0001|TWO_SIDED|95.0|4.62|45.11|||Cochran-Mantel-Haenszel|||||45.11|4.62|<0.0001
74062864|NCT03611751|147677710|SUPERIORITY||Odds Ratio (OR)|2.85||||0.0002|TWO_SIDED|95.0|1.61|5.03|||Cochran-Mantel-Haenszel|||||5.03|1.61|0.0002
73882649|NCT04913610|147299347|OTHER||||||=|0.366||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.366
74062865|NCT03611751|147677711|SUPERIORITY||Mean Difference (Net)|-23.6|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-26.9|-20.3|||ANCOVA|||||-20.3|-26.9|<0.0001
74062866|NCT03611751|147677711|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|-10.5|-3.9|||ANCOVA|||||-3.9|-10.5|<0.0001
74062867|NCT03611751|147677712|SUPERIORITY||Odds Ratio (OR)|6.4||||0.0005|TWO_SIDED|95.0|1.94|21.15|||Cochran-Mantel-Haenszel|||||21.15|1.94|0.0005
74062868|NCT03611751|147677712|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0928|TWO_SIDED|95.0|0.89|3.71|||Cochran-Mantel-Haenszel|||||3.71|0.89|0.0928
74062869|NCT03611751|147677713|SUPERIORITY||Odds Ratio (OR)|6.85|||<|0.0001|TWO_SIDED|95.0|4.34|10.81|||Cochran-Mantel-Haenszel|||||10.81|4.34|<0.0001
74062870|NCT03611751|147677713|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.77|3.91|||Cochran-Mantel-Haenszel|||||3.91|1.77|<0.0001
74062871|NCT03611751|147677714|SUPERIORITY||Odds Ratio (OR)|5.38|||<|0.0001|TWO_SIDED|95.0|3.42|8.47|||Cochran-Mantel-Haenszel|||||8.47|3.42|<0.0001
74062872|NCT03611751|147677715|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0621|TWO_SIDED|95.0|0.88|11.79|||Cochran-Mantel-Haenszel|||||11.79|0.88|0.0621
74062873|NCT03611751|147677716|SUPERIORITY||Odds Ratio (OR)|0.64||||0.6692|TWO_SIDED|95.0|0.06|7.46|||Cochran-Mantel-Haenszel|||||7.46|0.06|0.6692
74062874|NCT03611751|147677716|SUPERIORITY||Odds Ratio (OR)|0.32||||0.3793|TWO_SIDED|95.0|0.02|5.56|||Cochran-Mantel-Haenszel|||||5.56|0.02|0.3793
74062875|NCT03611751|147677717|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0004|TWO_SIDED|95.0|1.29|2.41|||Cochran-Mantel-Haenszel|||||2.41|1.29|0.0004
74062876|NCT03611751|147677718|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.45|2.78|||Cochran-Mantel-Haenszel|||||2.78|1.45|<0.0001
74062877|NCT03611751|147677719|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
74062878|NCT03611751|147677720|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.78|3.43|||Cochran-Mantel-Haenszel|||||3.43|1.78|<0.0001
74062879|NCT03611751|147677721|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.0001|TWO_SIDED|95.0|1.78|3.36|||Cochran-Mantel-Haenszel|||||3.36|1.78|<0.0001
74062880|NCT03611751|147677722|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0001|TWO_SIDED|95.0|1.43|3.01|||Cochran-Mantel-Haenszel|||||3.01|1.43|0.0001
74062881|NCT03467971|147677723|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|175.6652|||||TWO_SIDED|90.0|153.779|200.6664||||||Statistical Analysis for Metformin||200.6664|153.7790|
74062882|NCT03467971|147677723|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|104.457|||||TWO_SIDED|90.0|97.766|111.606||||||Statistical Analysis for Gliclazide||111.6060|97.7660|
73882650|NCT04913610|147299348|OTHER||||||=|0.869||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.869
74062883|NCT03467971|147677724|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|180.7734|||||TWO_SIDED|90.0|157.0135|208.1287||||||Statistical Analysis for Metformin||208.1287|157.0135|
74062884|NCT03467971|147677724|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.0818|||||TWO_SIDED|90.0|98.0047|112.6699||||||Statistical Analysis for Gliclazide||112.6699|98.0047|
74062885|NCT03467971|147677725|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|127.7779|||||TWO_SIDED|90.0|110.2732|148.0612||||||Statistical Analysis for Metformin||148.0612|110.2732|
74062886|NCT03467971|147677725|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.4183|||||TWO_SIDED|90.0|94.5723|117.5081||||||Statistical Analysis for Gliclazide||117.5081|94.5723|
74062887|NCT01488071|147677734|NON_INFERIORITY_OR_EQUIVALENCE|"Mixed model for repeated measurements (MMRM), using all available data, with a freely varying mean and covariance structures and with treatment, week, and site group as fixed factors and the baseline score as a covariate. The model also included interaction between week and baseline score, as well as interaction between week and treatment.~Non-inferiority, upper limit of Confidence Interval should not exceed 2."|Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.69||0.0018|TWO_SIDED|95.0|-3.51|-0.81||Under established non-inferiority the p-value is not adjusted.|Mixed Models Analysis|MMRM||||-0.81|-3.51|0.0018
74062888|NCT01488071|147677735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|0.72||0.0054|TWO_SIDED|95.0|-3.45|-0.6||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.60|-3.45|0.0054
74062889|NCT01488071|147677736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.56||0.0008|TWO_SIDED|95.0|-2.98|-0.8||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.80|-2.98|0.0008
74062890|NCT01488071|147677737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.57||0.0007|TWO_SIDED|95.0|-3.04|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.81|-3.04|0.0007
74062891|NCT01488071|147677738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0023|TWO_SIDED|95.0|-0.48|-0.11||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.11|-0.48|0.0023
74062892|NCT01488071|147677739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.0075|TWO_SIDED|95.0|-0.47|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.07|-0.47|0.0075
74062893|NCT01488071|147677740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0048|TWO_SIDED|95.0|-0.42|-0.08||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.08|-0.42|0.0048
74062894|NCT01488071|147677741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0055|TWO_SIDED|95.0|-0.42|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.07|-0.42|0.0055
74062895|NCT01488071|147677742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0012|TWO_SIDED|95.0|1.26|2.6||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.60|1.26|0.0012
74062896|NCT01488071|147677743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0014|TWO_SIDED|95.0|1.26|2.65||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.65|1.26|0.0014
74062897|NCT01488071|147677744|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0054|TWO_SIDED|95.0|1.17|2.52||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.52|1.17|0.0054
74062898|NCT01488071|147677745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0002|TWO_SIDED|95.0|1.39|2.9||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.90|1.39|0.0002
74062899|NCT01488071|147677746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.72||0.0021|TWO_SIDED|95.0|-3.63|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.81|-3.63|0.0021
74062900|NCT01488071|147677747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.75||0.0209|TWO_SIDED|95.0|-3.23|-0.27||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.27|-3.23|0.0209
74062901|NCT03302299|147677786|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.01|TWO_SIDED|95.0|0.94|2.71||global p-value for 3-category alcohol use variable in a multivariable generalized estimating equation logistic regression model of sub-optimal INH adherence.|Regression, Logistic||OR for participants with moderate alcohol use in the prior 3 months, compared to those with no alcohol use in the prior 3 months.|||2.71|0.94|<0.01
74062902|NCT03302299|147677786|SUPERIORITY||Odds Ratio (OR)|2.78|||<|0.01|TWO_SIDED|95.0|1.62|4.76||global p-value for 3-category alcohol use variable in a multivariable generalized estimating equation logistic regression model of sub-optimal INH adherence.|Regression, Logistic||OR is for participants with unhealthy alcohol use in the prior 3 months, compared to those with no alcohol use in the prior 3 months.|||4.76|1.62|<0.01
74062903|NCT02239692|147677792|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-3.93|||<|0.0001|TWO_SIDED|95.0|-4.99|-2.87||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||-2.87|-4.99|<0.0001
74062904|NCT02239692|147677793|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-4.38|||<|0.0001|TWO_SIDED|95.0|-5.34|-3.41||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||-3.41|-5.34|<0.0001
74062905|NCT02239692|147677794|SUPERIORITY_OR_OTHER||Adjusted estimated odds ratio|9.18|||<|0.0001|TWO_SIDED|95.0|4.36|19.32||p-value corresponds to a two-sided test of superiority.|Regression, Logistic|Logistic regression with the failure/success status as dependent variable, and treatment, country and timing of colonoscopy as factors.|The estimated odds ratio compares the odds of being a responder in the PICOPREP tailored dosing schedule vs. the PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||19.32|4.36|<0.0001
74062906|NCT04318535|147677798|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of Cmax falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.157|||||TWO_SIDED|90.0|1.103|1.213|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.213|1.103|
74062907|NCT04318535|147677799|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of AUC(0-t) falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.032|||||TWO_SIDED|90.0|0.974|1.094|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.094|0.974|
74062908|NCT04318535|147677800|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of AUC(0-inf) falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.03|||||TWO_SIDED|90.0|0.971|1.093|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.093|0.971|
74062909|NCT01901146|147677813|EQUIVALENCE|The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% CI of the risk difference of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%).|Risk Difference (RD)|7.3||||0.0508|TWO_SIDED|90.0|1.2|13.4|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% confidence interval (CI) of the Risk Difference (RD; ABP 980 - Trastuzumab) of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%), estimated using a generalized linear model adjusted for stratification factors tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||13.4|1.2|0.0508
74062910|NCT01901146|147677813|EQUIVALENCE|If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the risk ratio of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab estimated using a generalized linear model adjusted for stratification factors, with the margin of (0.7586, 1/0.7586). If the test of equivalence on the RD was not successful, the RR of pCR and 90% CI were considered to be descriptive.|Risk Ratio (RR)|1.1877||||0.043|TWO_SIDED|90.0|1.0327|1.366|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the Risk Ratio (RR; ABP 980 / Trastuzumab) of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab, estimated using a generalized linear model adjusted for stratification factors: tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.3660|1.0327|0.0430
74062911|NCT01901146|147677814|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|6.0||||0.1086|TWO_SIDED|90.0|-0.2|12.2|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||12.2|-0.2|0.1086
74062912|NCT01901146|147677814|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.1463||||0.0807|TWO_SIDED|90.0|1.008|1.3035|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.3035|1.0080|0.0807
74062913|NCT01901146|147677815|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|8.0||||0.0253|TWO_SIDED|90.0|2.1|13.9|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||13.9|2.1|0.0253
74062914|NCT01901146|147677815|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.2746||||0.0245|TWO_SIDED|90.0|1.0673|1.5222|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.5222|1.0673|0.0245
74062915|NCT01160198|147677827|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 once-daily||||<0.0001
73882651|NCT04913610|147299348|OTHER||||||=|0.973||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.973
73882652|NCT04913610|147299348|OTHER||||||=|0.744||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.744
74062916|NCT01160198|147677827|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 twice-daily||||<0.0001
74062917|NCT01160198|147677829|SUPERIORITY_OR_OTHER|||||||0.788|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily||||0.788
74062918|NCT01160198|147677829|SUPERIORITY_OR_OTHER|||||||0.911|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily||||0.911
74062919|NCT01160198|147677829|SUPERIORITY_OR_OTHER|||||||0.7|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily||||0.700
74062920|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.29|0.17|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 2||0.17|-0.29|1
74062921|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1||95.0|-0.57|0.31|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 4||0.31|-0.57|1
74062922|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.75|0.46|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 6||0.46|-0.75|1
74062923|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||1|TWO_SIDED|95.0|-1.05|0.53|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 8||0.53|-1.05|1
74062924|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.49|TWO_SIDED|95.0|-0.35|0.09|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2||0.09|-0.35|0.490
74062925|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||1|TWO_SIDED|95.0|-0.58|0.29|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4||0.29|-0.58|1
74062926|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.68|0.51|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6||0.51|-0.68|1
74062927|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.84|0.72|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8||0.72|-0.84|1
74062928|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.29|0.15|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2||0.15|-0.29|1
74062929|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.45|0.42|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4||0.42|-0.45|1
74062930|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||1|TWO_SIDED|95.0|-0.53|0.65|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6||0.65|-0.53|1
74062931|NCT01160198|147677830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||1|TWO_SIDED|95.0|-0.58|0.98|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8||0.98|-0.58|1
74062932|NCT02413879|147677832|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<0.001
74062933|NCT02413879|147677834|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<0.001
74062934|NCT01467570|147677872|NON_INFERIORITY_OR_EQUIVALENCE|The differences between study groups were considered significant when the p value was \<0.05 or when the 95% CI for RD or MD did not include 0 (equivalent to p \< 0.05).||||||0.28|||||||t-test, 1 sided|||||||0.28
73882653|NCT04913610|147299348|OTHER||||||=|0.794||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.794
73882654|NCT04913610|147299349|OTHER||||||=|0.559||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.559
74062935|NCT03555890|147677891|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.975|||||TWO_SIDED|90.0|0.948|1.003||||||||1.003|0.948|
74062936|NCT03555890|147677892|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.978|||||TWO_SIDED|90.0|0.958|0.998||||||||0.998|0.958|
74062937|NCT03555890|147677893|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.934|||||TWO_SIDED|90.0|0.875|0.998||||||||0.998|0.875|
74062938|NCT03555890|147677894|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.857|||||TWO_SIDED|90.0|0.815|0.902||||||||0.902|0.815|
74062939|NCT03372369|147677955|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the CDC poster between baseline and followup is 0.||||<0.0001
74062940|NCT03372369|147677955|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the patient-centered poster between baseline and followup is 0.||||<0.0001
74062941|NCT03372369|147677955|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the contraceptive knowledge score between baseline and followup than the CDC poster.||||<0.0001
74062942|NCT03372369|147677956|SUPERIORITY||||||<|0.001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the CDC poster between baseline and followup is 0.||||<0.001
74062943|NCT03372369|147677956|SUPERIORITY||||||<|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the patient-centered poster between baseline and followup is 0.||||<0.01
74062944|NCT03372369|147677956|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the effective contraception preference score between baseline and followup than the CDC poster.||||>0.01
74062945|NCT03372369|147677957|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the CDC poster between baseline and followup is 0.||||>0.01
73882655|NCT04913610|147299349|OTHER||||||=|0.786||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.786
74062946|NCT03372369|147677957|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.||||>0.01
74062947|NCT03372369|147677957|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the perceived pregnancy risk score between baseline and followup than the CDC poster.||||>0.01
74062948|NCT03372369|147677958|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the CDC poster between baseline and followup is 0.||||>0.01
74062949|NCT03372369|147677958|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.||||>0.01
74062950|NCT03372369|147677958|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the accuracy of perceived pregnancy risk score between baseline and followup than the CDC poster.||||>0.01
74062951|NCT03870737|147677960|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 24.81, df = 1/40.||Outcomes fitted via a mixed effects model with time as predictor.||||<.0001
74062952|NCT03870737|147677962|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|Time: F = 5.78, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.02
74062953|NCT03870737|147677963|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|Time: F = 14.28, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.0005
74062954|NCT03870737|147677964|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|Time: F = .19, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.67
73882656|NCT04913610|147299349|OTHER||||||=|0.423||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.423
74062955|NCT03870737|147677965|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|Time: F = .08, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.76
74062956|NCT03870737|147677966|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|Time: F = .06, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.80
73882657|NCT04913610|147299349|OTHER||||||=|0.92||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.920
74062957|NCT02320838|147677984|OTHER||||||<|0.001||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||<0.001
74062958|NCT02320838|147677985|OTHER|||||||0.04||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.04
73888269|NCT01746901|147309546|SUPERIORITY_OR_OTHER||LS Mean Difference|5.16|||<|0.0001|TWO_SIDED|95.0|2.99|7.32|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||7.32|2.99|<0.0001
74062959|NCT02320838|147677986|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
74062960|NCT02320838|147677987|OTHER|||||||0.001||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.001
74062961|NCT02320838|147677988|OTHER|||||||0.003||||||A priori threshold for statistical significance. p\<0.05|t-test, 2 sided|||||||0.003
74062962|NCT02320838|147677989|OTHER|||||||0.023||||||A priori threshold for statistical significance. p\<0.05|Chi-squared|||||||0.023
74062963|NCT02320838|147677990|OTHER|||||||0.003||||||A priori threshold for statistical significance. p\<0,05|t-test, 2 sided|||||||0.003
74062964|NCT02320838|147677991|OTHER|||||||0.8||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.8
74062965|NCT02320838|147677992|OTHER|||||||0.02||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.02
74062966|NCT02320838|147677993|OTHER|||||||0.4||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.4
74062967|NCT02320838|147677994|OTHER|||||||0.8|||||||ANOVA|||||||0.8
74062968|NCT02320838|147677995|OTHER|||||||1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||1.0
74062969|NCT02320838|147677996|OTHER|||||||0.4||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.4
74062970|NCT02320838|147677997|OTHER|||||||0.1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.1
74062971|NCT02320838|147677998|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
74062972|NCT02320838|147677999|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
74062973|NCT02320838|147678000|OTHER|||||||0.5||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.5
74062974|NCT02320838|147678001|OTHER|||||||0.6||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.6
74062975|NCT02320838|147678002|OTHER|||||||0.1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.1
74062976|NCT02320838|147678003|OTHER|||||||0.2||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.2
74062977|NCT02320838|147678004|OTHER|||||||1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||1.0
74062978|NCT01398982|147678005|NON_INFERIORITY_OR_EQUIVALENCE|Based on our published prospective, nonrandomized study using TAP block in abdominally-based autologous tissue breast reconstruction, 40 patients per group would achieve 85% power to detect a 65% reduction in mean total opioid consumption between the control and study groups (significance level alpha = 0.05; using a two-sided Wilcoxon rank-sum test).||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
74062979|NCT01791127|147678020|SUPERIORITY|The primary endpoint 1 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 12 months) to 94.0%, with Type I error (alpha) or 0.025 and power of 80%.|||||<|0.0001|||||||Exact, binomial|||||||<0.0001
74062980|NCT01791127|147678021|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint 2 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 12 months) to 94.0%, with Type I error (alpha) or 0.025 and power of 80%.||||<0.0001
74062981|NCT01791127|147678022|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint 3 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (successful sensing and pacing rate at 12 months) to 97.0%, with Type I error (alpha) or 0.025 and power of 80%.||||<0.0001
74062982|NCT01791127|147678023|SUPERIORITY|||||||||||||||||The primary endpoint 4 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 5 years) to 92.5%, with Type I error (alpha) or 0.025 and power of 80%.|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.|||
74062983|NCT03964220|147678035|OTHER||Hazard Ratio (HR)|0.65||||0.044|TWO_SIDED|95.0|0.427|0.99|||Regression, Cox|||The time to first exacerbation was analysis using Cox Proportional Hazards model with group status as the only independent variable assessing the risk of exacerbation across Tio and NonTio groups.||0.990|0.427|0.044
74062984|NCT03964220|147678036|OTHER||||||<|0.0001|||||||Negative binomial regression|||Analysis for the rate of exacerbation between Tio and NonTio groups within 6 months of follow-up.||||< 0.0001
74062985|NCT03964220|147678036|OTHER||||||<|0.0001|||||||Negative binomial regression|||Analysis for the rate of exacerbation between Tio and NonTio groups within 1 year of follow-up.||||< 0.0001
74062986|NCT00589693|147678065|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority will be established if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in clinical cure rate (doripenem minus imipenem-cilastatin) is greater than 15%|Difference of 2 binomial proportions|-11.2|||||TWO_SIDED|95.0|-26.3|3.8|||Normal approximation of 2 proportions|||Null Hypothesis: The clinical cure rate of doripenem assessed at the EOT visit is more than 15% inferior to that of imipenem-cilastatin||3.8|-26.3|
74062987|NCT00589693|147678066|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|-18.8|||||TWO_SIDED|95.0|-57.2|19.5|||Normal approximation of 2 proportions|||||19.5|-57.2|
74062988|NCT00589693|147678067|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|-5.6|||||TWO_SIDED|95.0|-23.0|11.7|||Normal approximation of 2 proportions|||||11.7|-23.0|
74062989|NCT00589693|147678068|SUPERIORITY_OR_OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
74062990|NCT00589693|147678069|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|6.7|||||TWO_SIDED|95.0|-5.0|18.5|||Normal approximation of 2 proportions|||||18.5|-5.0|
74062991|NCT03231709|147678070|OTHER|||||||0.0141|||||||Mainland-Gart Test|||||||0.0141
74062992|NCT00190684|147678089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for systolic BP|Wilcoxon signed-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74062993|NCT00190684|147678089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for diastolic BP|Wilcoxon sign-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74062994|NCT00190684|147678090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for pulse|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74062995|NCT00190684|147678091|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74062996|NCT00190684|147678092|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74062997|NCT00190684|147678093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74062998|NCT00190684|147678093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
73882658|NCT04913610|147299350|OTHER||||||=|0.981||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.981
73882659|NCT04913610|147299350|OTHER||||||=|0.981||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.981
73882660|NCT04913610|147299350|OTHER||||||=|0.96||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.960
74062999|NCT00190684|147678093|SUPERIORITY_OR_OTHER|||||||0.644||95.0||||p-value is for weight 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.644
74063000|NCT00190684|147678093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
73882661|NCT04913610|147299350|OTHER||||||=|0.96||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.960
73882662|NCT04913610|147299351|OTHER||||||=|0.157||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.157
73882663|NCT04913610|147299351|OTHER||||||=|0.15||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.150
74063001|NCT00190684|147678093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74063002|NCT00190684|147678093|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for height 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.001
74063003|NCT00190684|147678093|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value is for height 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.044
74063004|NCT00190684|147678093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
73882664|NCT04913610|147299351|OTHER||||||=|0.15||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.150
73882665|NCT04913610|147299351|OTHER||||||=|0.173||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.173
74063005|NCT00190684|147678093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for BMI 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74063006|NCT00190684|147678093|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||p-value is for BMI 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.032
74063007|NCT00190684|147678093|SUPERIORITY_OR_OTHER|||||||0.351||95.0||||p-value is for BMI 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.351
74063008|NCT00190684|147678093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for BMI 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74063009|NCT00190684|147678094|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for RR interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74063010|NCT00190684|147678094|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for QRS Interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74063011|NCT00190684|147678094|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for QT Bazett Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74063012|NCT00190684|147678094|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||p-value is for QT Data Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.310
74063013|NCT00190684|147678094|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||p-value is for QT Fridericia Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.632
74063014|NCT00190684|147678095|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for HR.|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74063015|NCT00190684|147678097|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for Total Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
73882666|NCT04913610|147299352|OTHER||||||=|0.619||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.619
74063016|NCT00190684|147678097|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Inattentive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74063017|NCT00190684|147678097|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for Hyperactive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
74063018|NCT00190684|147678098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CGI ADHD Severity within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||||||<0.001
74063019|NCT00190684|147678099|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CPRS ADHD Index Subscale within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74063020|NCT00190684|147678099|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for CPRS Cognitive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
74063021|NCT00190684|147678099|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||p-value is for CPRS Hyperactive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.026
74063022|NCT00190684|147678099|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CPRS Oppositional Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
74063023|NCT01494649|147678115|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1||||0.2294|TWO_SIDED|95.0|-0.26|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|The model included treatment as a fixed factor and basline Schiff score as a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favoured stannous fluoride toothpaste.|Null hypothesis is no difference between treatments. Tests were 2-sided.||0.06|-0.26|0.2294
74063024|NCT01494649|147678116|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12||||0.1792||95.0|-0.3|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||0.06|-0.30|0.1792
74063025|NCT01494649|147678117|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||-0.30|-0.74|<0.0001
74063026|NCT01494649|147678118|SUPERIORITY_OR_OTHER||Mean adjusted difference|-0.08||||0.9445|TWO_SIDED|95.0|-2.49|2.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Tactile Threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2.32|-2.49|0.9445
74063027|NCT01494649|147678119|SUPERIORITY_OR_OTHER||Adjusted mean|-2.07||||0.22|TWO_SIDED|95.0|-5.38|1.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||1.25|-5.38|0.220
74063028|NCT01494649|147678120|SUPERIORITY_OR_OTHER||Mean adjusted difference|8.69||||0.0004|TWO_SIDED|95.0|3.96|13.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||13.43|3.96|0.0004
74063029|NCT02139306|147678140|SUPERIORITY||Mean Difference (Net)|0.597|STANDARD_ERROR_OF_MEAN|0.957||0.5336|TWO_SIDED|95.0|-1.2881|2.4813|||Mixed-model, repeated-measures|||||2.4813|-1.2881|0.5336
74063030|NCT02139306|147678141|SUPERIORITY||Rate ratio|0.8567|STANDARD_ERROR_OF_MEAN|0.1577||0.4008|TWO_SIDED|95.0|0.5973|1.2288|||Negative binomial regression|||||1.2288|0.5973|0.4008
73882667|NCT04913610|147299352|OTHER||||||=|0.194||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.194
73882668|NCT04913610|147299352|OTHER||||||=|0.518||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.518
73882669|NCT04913610|147299352|OTHER||||||=|0.652||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.652
73882670|NCT04913610|147299353|OTHER||||||=|0.386||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.386
74063031|NCT02139306|147678142|SUPERIORITY||Mean Difference (Net)|0.272|STANDARD_ERROR_OF_MEAN|1.93||0.8881|TWO_SIDED|95.0|-3.5292|4.0731|||Mixed-model, repeated measures|||||4.0731|-3.5292|0.8881
73882671|NCT04913610|147299353|OTHER||||||=|0.279||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.279
73882672|NCT04913610|147299353|OTHER||||||=|0.385||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.385
74063032|NCT02139306|147678143|SUPERIORITY||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.1312||0.6208|TWO_SIDED|95.0|-0.3233|0.1934|||Mixed-model, repeated measures|||||0.1934|-0.3233|0.6208
74063033|NCT02913261|147678157|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.65|4.22|||Stratified Cochran-Mantel-Haenszel|||||4.22|1.65|<.0001
74063034|NCT02913261|147678158|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0005|TWO_SIDED|95.0|1.43|3.94|||Stratified Cochran-Mantel-Haenszel|||||3.94|1.43|0.0005
74063035|NCT02913261|147678159|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0029|TWO_SIDED|95.0|1.24|3.17|||Stratified Cochran-Mantel-Haenszel|||||3.17|1.24|0.0029
74063036|NCT02913261|147678171|SUPERIORITY||Odds Ratio (OR)|3.07|||<|0.0001|TWO_SIDED|95.0|1.8|5.25|||Stratified Cochran-Mantel-Haenszel|||||5.25|1.80|<.0001
74063037|NCT01236053|147678184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0002|TWO_SIDED|95.0|1.07|1.24|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)"|||1.24|1.07|0.0002
74063038|NCT01236053|147678184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.0976|TWO_SIDED|95.0|0.99|1.15|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.15|0.99|0.0976
74063039|NCT01236053|147678184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||<|0.0001|TWO_SIDED|95.0|1.23|1.36|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)"|||1.36|1.23|<0.0001
74063040|NCT01236053|147678184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||<|0.0001|TWO_SIDED|95.0|1.13|1.26|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.26|1.13|<0.0001
73882673|NCT04913610|147299353|OTHER||||||=|0.755||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.755
74063041|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.1468|TWO_SIDED|95.0|0.97|1.23|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.23|0.97|0.1468
74063042|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.8545|TWO_SIDED|95.0|0.9|1.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.14|0.90|0.8545
74063043|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.0001|TWO_SIDED|95.0|1.27|1.48|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.48|1.27|<0.0001
74063044|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27|||<|0.0001|TWO_SIDED|95.0|1.18|1.37|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.37|1.18|<0.0001
74063045|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.0033|TWO_SIDED|95.0|1.07|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.43|1.07|0.0033
74063046|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0474|TWO_SIDED|95.0|1.0|1.33|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.33|1.00|0.0474
74063047|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||<|0.0001|TWO_SIDED|95.0|1.16|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.43|1.16|<0.0001
74063048|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0008|TWO_SIDED|95.0|1.08|1.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.32|1.08|0.0008
73882674|NCT00659061|147299355|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||at baseline|Chi-squared|||||||0.32
73882675|NCT00659061|147299355|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||at endline|Chi-squared|||||||<0.001
74063049|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.019|TWO_SIDED|95.0|1.03|1.33|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.33|1.03|0.0190
74063050|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.3366|TWO_SIDED|95.0|0.94|1.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.21|0.94|0.3366
74063051|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0001|TWO_SIDED|95.0|1.09|1.31|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.31|1.09|0.0001
73882676|NCT00659061|147299357|SUPERIORITY_OR_OTHER||||||<|0||95.0|||||ANOVA|adjusted for baseline, child age, sex, number of sprinkles sachets consumed, number of mths between enrollment and endline Hb measurement)||||||<0.000
73882677|NCT00659061|147299358|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||baseline|Chi-squared|||||||0.34
74063052|NCT01236053|147678185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.0464|TWO_SIDED|95.0|1.0|1.2|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.20|1.00|0.0464
74063053|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.1194|TWO_SIDED|95.0|0.97|1.26|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.26|0.97|0.1194
74063054|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.7004|TWO_SIDED|95.0|0.9|1.17|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.17|0.90|0.7004
74063055|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.0001|TWO_SIDED|95.0|1.26|1.49|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.49|1.26|<0.0001
74063056|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|||<|0.0001|TWO_SIDED|95.0|1.16|1.38|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.38|1.16|<0.0001
74063057|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.0134|TWO_SIDED|95.0|1.03|1.34|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.34|1.03|0.0134
74063058|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.1592|TWO_SIDED|95.0|0.96|1.25|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.25|0.96|0.1592
74063059|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.24|1.47|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.47|1.24|<0.0001
74063060|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25|||<|0.0001|TWO_SIDED|95.0|1.14|1.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.36|1.14|<0.0001
74063061|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.0131|TWO_SIDED|95.0|1.03|1.33|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.33|1.03|0.0131
74063062|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.2731|TWO_SIDED|95.0|0.95|1.22|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.22|0.95|0.2731
74063063|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0012|TWO_SIDED|95.0|1.06|1.28|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.28|1.06|0.0012
74063064|NCT01236053|147678186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.1477|TWO_SIDED|95.0|0.98|1.17|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.17|0.98|0.1477
74063065|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.0369|TWO_SIDED|95.0|1.01|1.41|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||1.41|1.01|0.0369
74063066|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.3132|TWO_SIDED|95.0|0.92|1.29|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.29|0.92|0.3132
74063067|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.0762|TWO_SIDED|95.0|0.99|1.26|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||1.26|0.99|0.0762
74063068|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.7243|TWO_SIDED|95.0|0.91|1.15|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.15|0.91|0.7243
74063069|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0775|TWO_SIDED|95.0|0.97|1.65|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||1.65|0.97|0.0775
74063070|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.2649|TWO_SIDED|95.0|0.89|1.52|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.52|0.89|0.2649
74063071|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.0257|TWO_SIDED|95.0|1.02|1.43|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||1.43|1.02|0.0257
74063072|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.254|TWO_SIDED|95.0|0.93|1.3|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.30|0.93|0.2540
74063073|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.5141|TWO_SIDED|95.0|0.76|1.75|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||1.75|0.76|0.5141
74063074|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8208|TWO_SIDED|95.0|0.69|1.6|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.60|0.69|0.8208
73882678|NCT00659061|147299358|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||endline|Chi-squared|||||||<0.001
74063075|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0562|TWO_SIDED|95.0|0.99|1.62|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||1.62|0.99|0.0562
74063076|NCT01236053|147678187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.2596|TWO_SIDED|95.0|0.9|1.47|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.47|0.90|0.2596
74063077|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.0709|TWO_SIDED|95.0|0.99|1.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.28|0.99|0.0709
74063078|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.4996|TWO_SIDED|95.0|0.92|1.19|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.19|0.92|0.4996
74063079|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34|||<|0.0001|TWO_SIDED|95.0|1.23|1.45|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.45|1.23|<0.0001
74063080|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24|||<|0.0001|TWO_SIDED|95.0|1.14|1.35|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.35|1.14|<0.0001
74063081|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.0062|TWO_SIDED|95.0|1.05|1.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.36|1.05|0.0062
74063082|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.1144|TWO_SIDED|95.0|0.98|1.26|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.26|0.98|0.1144
74063083|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|||<|0.0001|TWO_SIDED|95.0|1.3|1.55|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.55|1.30|<0.0001
74063084|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31|||<|0.0001|TWO_SIDED|95.0|1.2|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.43|1.20|<0.0001
73882679|NCT00659061|147299359|SUPERIORITY_OR_OTHER|||||||0||95.0||||endline|ANOVA|adjusted for baseline child age, sex, # of sprinkle sachet consumed, # of mths between enrollment and endline Hb measurement||||||0.000
74063085|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.0469|TWO_SIDED|95.0|1.0|1.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.29|1.00|0.0469
74063086|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.5169|TWO_SIDED|95.0|0.92|1.19|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.19|0.92|0.5169
74063087|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.0103|TWO_SIDED|95.0|1.03|1.24|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.24|1.03|0.0103
74063088|NCT01236053|147678188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.4182|TWO_SIDED|95.0|0.95|1.14|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.14|0.95|0.4182
74063089|NCT01236053|147678189|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.65||||0.3597|TWO_SIDED|95.0|0.26|1.62|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.62|0.26|0.3597
74063090|NCT01236053|147678189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.1845|TWO_SIDED|95.0|0.21|1.34|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.34|0.21|0.1845
74063091|NCT01236053|147678189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9142|TWO_SIDED|95.0|0.58|1.84|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.84|0.58|0.9142
74063092|NCT01236053|147678189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.6524|TWO_SIDED|95.0|0.49|1.57|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.57|0.49|0.6524
74063093|NCT01236053|147678190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.2875|TWO_SIDED|95.0|0.17|1.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.70|0.17|0.2875
74063094|NCT01236053|147678190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.2042|TWO_SIDED|95.0|0.15|1.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.51|0.15|0.2042
73882680|NCT00659061|147299360|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||baseline|Chi-squared|||||||0.7
73882681|NCT00659061|147299360|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||endline|Chi-squared|||||||0.02
74063095|NCT01236053|147678190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.4733|TWO_SIDED|95.0|0.38|8.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||8.06|0.38|0.4733
74063096|NCT01236053|147678190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.7867|TWO_SIDED|95.0|0.26|5.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||5.85|0.26|0.7867
74063097|NCT01236053|147678190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53||||0.0049|TWO_SIDED|95.0|1.47|8.5|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||8.50|1.47|0.0049
74063098|NCT01236053|147678190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.87||||0.0218|TWO_SIDED|95.0|1.17|7.08|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||7.08|1.17|0.0218
74063099|NCT01236053|147678190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.849|TWO_SIDED|95.0|0.27|2.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.92|0.27|0.8490
74063100|NCT01236053|147678190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.6263|TWO_SIDED|95.0|0.22|2.46|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.46|0.22|0.6263
74063101|NCT01236053|147678190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.4122|TWO_SIDED|95.0|0.19|1.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.97|0.19|0.4122
74063102|NCT01236053|147678190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.2642|TWO_SIDED|95.0|0.16|1.66|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.66|0.16|0.2642
73882682|NCT00659061|147299361|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||baseline|Chi-squared|||||||0.62
73882683|NCT00659061|147299361|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||endline|Chi-squared|||||||0.89
73882684|NCT00659061|147299362|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||baseline|Chi-squared|||||||0.93
73882685|NCT00659061|147299362|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||endline|Chi-squared|||||||0.49
74063103|NCT01236053|147678191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.7891|TWO_SIDED|95.0|0.31|2.43|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.43|0.31|0.7891
74063104|NCT01236053|147678191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.6216|TWO_SIDED|95.0|0.27|2.17|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.17|0.27|0.6216
74063105|NCT01236053|147678191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.6893|TWO_SIDED|95.0|0.31|5.96|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||5.96|0.31|0.6893
74063106|NCT01236053|147678191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.9273|TWO_SIDED|95.0|0.24|4.84|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||4.84|0.24|0.9273
74063107|NCT01236053|147678191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.598|TWO_SIDED|95.0|0.47|3.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.78|0.47|0.5980
74063108|NCT01236053|147678191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8572|TWO_SIDED|95.0|0.38|3.18|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||3.18|0.38|0.8572
74063109|NCT01236053|147678191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7807|TWO_SIDED|95.0|0.26|2.77|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.77|0.26|0.7807
73882686|NCT01210716|147299363|NON_INFERIORITY_OR_EQUIVALENCE|If the lower 97.5% confidence limit on the mean of the paired differences is greater than -15% of the Control group mean (i.e., p-value \<=0.05), then the Test group will be considered non-inferior in the primary efficacy parameter to Control at the margin of 15%.|Mean Difference (Final Values)|6.69|STANDARD_DEVIATION|6.97|<|0.001|ONE_SIDED|95.0|4.0||||paired t-test|||A one-sample t-test on the mean of paired differences was used to evaluate the primary objective. Sample size was determined using historical data and the 95% chi-square upper confidence limit on the observed standard deviation of the paired differences. A minimum sample of 27 pairs was required to demonstrate the AMICUS procedure to be non-inferior to Spectra with a mean efficiency of plasma removal with a non-inferiority margin of 15% with at least 97.5% (one-sided) confidence and 90% power.|||4.0|<0.001
73888270|NCT01746901|147309546|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.9766|TWO_SIDED|95.0|-2.13|2.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.20|-2.13|0.9766
74063110|NCT01236053|147678191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.5579|TWO_SIDED|95.0|0.21|2.32|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.32|0.21|0.5579
74063111|NCT01236053|147678191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|95.0|0.4|2.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.53|0.40|0.9932
74063112|NCT01236053|147678191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.6901|TWO_SIDED|95.0|0.32|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.11|0.32|0.6901
74063113|NCT01236053|147678193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.431|TWO_SIDED|95.0|0.19|2.01|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.01|0.19|0.4310
74063114|NCT01236053|147678193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.3226|TWO_SIDED|95.0|0.17|1.79|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.79|0.17|0.3226
74063115|NCT01236053|147678193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.6206|TWO_SIDED|95.0|0.4|4.59|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.59|0.40|0.6206
73888271|NCT01746901|147309546|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.61|||<|0.0001|TWO_SIDED|95.0|-6.78|-2.44|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.44|-6.78|<0.0001
74063116|NCT01236053|147678193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.8557|TWO_SIDED|95.0|0.33|3.84|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||3.84|0.33|0.8557
73882687|NCT01650558|147299377|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.27|||<=|0.05|TWO_SIDED|95.0|0.89|1.82||P-Value is not adjusted for multiple comparisons.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.82|0.89|<=0.05
73882688|NCT01650558|147299377|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.28|||<=|0.05|TWO_SIDED|95.0|0.89|1.83||P-Value is not adjusted for multiple comparisons.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.83|0.89|<=0.05
73888272|NCT01746901|147309546|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39||||0.7242|TWO_SIDED|95.0|-2.55|1.78|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.78|-2.55|0.7242
74063117|NCT01236053|147678193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.1498|TWO_SIDED|95.0|0.79|4.62|||Unadjusted Odds Ratio||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||4.62|0.79|0.1498
74063118|NCT01236053|147678193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.2645|TWO_SIDED|95.0|0.68|4.07|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||4.07|0.68|0.2645
74063119|NCT01236053|147678193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.5728|TWO_SIDED|95.0|0.16|2.79|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.79|0.16|0.5728
74063120|NCT01236053|147678193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.3727|TWO_SIDED|95.0|0.12|2.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.21|0.12|0.3727
74063121|NCT01236053|147678193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7743|TWO_SIDED|95.0|0.31|2.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.40|0.31|0.7743
74063122|NCT01236053|147678193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.4775|TWO_SIDED|95.0|0.24|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.94|0.24|0.4775
74063123|NCT01236053|147678194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.33||||0.0032|TWO_SIDED|95.0|1.95|27.56|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||27.56|1.95|0.0032
74063124|NCT01236053|147678194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39||||0.1251|TWO_SIDED|95.0|0.71|16.17|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||16.17|0.71|0.1251
74063125|NCT01236053|147678194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.22||||0.0261|TWO_SIDED|95.0|1.15|9.01|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||9.01|1.15|0.0261
74063126|NCT01236053|147678194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.209|TWO_SIDED|95.0|0.65|7.17|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.17|0.65|0.2090
74063127|NCT01236053|147678195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
74063128|NCT01236053|147678195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.47||||0.0158|TWO_SIDED|95.0|1.78|258.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||258.8|1.78|0.0158
74063129|NCT01236053|147678195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86||||0.0524|TWO_SIDED|95.0|0.99|15.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||15.14|0.99|0.0524
74063130|NCT01236053|147678195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21||||0.0269|TWO_SIDED|95.0|1.21|22.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||22.51|1.21|0.0269
74063131|NCT01236053|147678195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.1888|TWO_SIDED|95.0|0.45|55.14|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||55.14|0.45|0.1888
74063132|NCT01236053|147678195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.999|TWO_SIDED|95.0|0.03|32.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||32.21|0.03|0.9990
74063133|NCT01236053|147678195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75||||0.2885|TWO_SIDED|95.0|0.33|43.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||43.08|0.33|0.2885
73888273|NCT01746901|147309546|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.45|||<|0.0001|TWO_SIDED|95.0|-6.62|-2.28|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.28|-6.62|<0.0001
74063134|NCT01236053|147678195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.9608|TWO_SIDED|95.0|0.06|13.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||13.87|0.06|0.9608
74063135|NCT01236053|147678195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
74063136|NCT01236053|147678195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.9253|TWO_SIDED|95.0|0.1|7.82|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.82|0.10|0.9253
74063137|NCT01236053|147678196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
74063138|NCT01236053|147678196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.47||||0.0158|TWO_SIDED|95.0|1.78|258.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||258.8|1.78|0.0158
74063139|NCT01236053|147678196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.0||||0.0141|TWO_SIDED|95.0|1.43|25.11|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||25.11|1.43|0.0141
73888274|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|19.0|||<|0.0001|TWO_SIDED|95.0|14.6|23.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.5|14.6|<0.0001
74063140|NCT01236053|147678196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.56||||0.0063|TWO_SIDED|95.0|1.83|40.02|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||40.02|1.83|0.0063
74063141|NCT01236053|147678196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.1888|TWO_SIDED|95.0|0.45|55.14|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||55.14|0.45|0.1888
74063142|NCT01236053|147678196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.999|TWO_SIDED|95.0|0.03|32.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||32.21|0.03|0.9990
74063143|NCT01236053|147678196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75||||0.2885|TWO_SIDED|95.0|0.33|43.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||43.08|0.33|0.2885
74063144|NCT01236053|147678196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.9608|TWO_SIDED|95.0|0.06|13.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||13.87|0.06|0.9608
74063145|NCT01236053|147678196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
74063146|NCT01236053|147678196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.9381||95.0|0.11|7.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.97|0.11|0.9381
74063147|NCT01236053|147678198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
74063148|NCT01236053|147678198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.55||||0.0157|TWO_SIDED|95.0|1.78|260.2|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||260.2|1.78|0.0157
74063149|NCT01236053|147678198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86||||0.0524|TWO_SIDED|95.0|0.99|15.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||15.14|0.99|0.0524
74063150|NCT01236053|147678198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8||||0.0333|TWO_SIDED|95.0|1.13|20.31|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||20.31|1.13|0.0333
74063151|NCT01236053|147678198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34||||0.2966|TWO_SIDED|95.0|0.35|32.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||32.06|0.35|0.2966
74063152|NCT01236053|147678198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.751|TWO_SIDED|95.0|0.03|12.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||12.31|0.03|0.7510
74063153|NCT01236053|147678198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.71||||0.1868|TWO_SIDED|95.0|0.4|113.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||113.4|0.40|0.1868
74063154|NCT01236053|147678198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.7558|TWO_SIDED|95.0|0.07|40.61|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||40.61|0.07|0.7558
74063155|NCT01236053|147678198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
74063156|NCT01236053|147678198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.9244|TWO_SIDED|95.0|0.1|7.81|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.81|0.10|0.9244
74063157|NCT01236053|147678199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0963|TWO_SIDED|95.0|0.96|1.7|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.70|0.96|0.0963
74063158|NCT01236053|147678199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.671|TWO_SIDED|95.0|0.69|1.27|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.27|0.69|0.6710
74063159|NCT01236053|147678199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84|||<|0.0001|TWO_SIDED|95.0|1.54|2.2|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.20|1.54|<0.0001
74063160|NCT01236053|147678199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||<|0.0001|TWO_SIDED|95.0|1.24|1.81|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.81|1.24|<0.0001
74063161|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.1184|TWO_SIDED|95.0|0.92|2.18|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.18|0.92|0.1184
73882689|NCT01650558|147299378|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.38|||<=|0.05|TWO_SIDED|95.0|0.83|2.3||No adjustment for multiple comparisons was made.|Fisher Exact|||||2.30|0.83|<=0.05
74063162|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8016|TWO_SIDED|95.0|0.59|1.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.50|0.59|0.8016
74063163|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.77|2.91|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.91|1.77|<0.0001
74063164|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||<|0.0001|TWO_SIDED|95.0|1.51|2.58|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.58|1.51|<0.0001
74063165|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6105|TWO_SIDED|95.0|0.65|2.08|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.08|0.65|0.6105
74063166|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.6797|TWO_SIDED|95.0|0.62|2.09|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.09|0.62|0.6797
74063167|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.0103|TWO_SIDED|95.0|1.12|2.39|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.39|1.12|0.0103
74063168|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.1629|TWO_SIDED|95.0|0.89|2.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.00|0.89|0.1629
74063169|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.4713|TWO_SIDED|95.0|0.73|1.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.97|0.73|0.4713
74063170|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.4505|TWO_SIDED|95.0|0.49|1.38|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.38|0.49|0.4505
74063171|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.0284|TWO_SIDED|95.0|1.04|2.01|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.01|1.04|0.0284
74063172|NCT01236053|147678200|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.6262|TWO_SIDED|95.0|0.77|1.54|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.54|0.77|0.6262
74063173|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0798|TWO_SIDED|95.0|0.95|2.41|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.41|0.95|0.0798
74063174|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8357|TWO_SIDED|95.0|0.64|1.73|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.73|0.64|0.8357
74063175|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.75|3.01|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.01|1.75|<0.0001
74063176|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.53|2.76|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.76|1.53|<0.0001
74063177|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7794|TWO_SIDED|95.0|0.63|1.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.85|0.63|0.7794
74063178|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.8075|TWO_SIDED|95.0|0.52|1.66|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.66|0.52|0.8075
74063179|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0001|TWO_SIDED|95.0|1.35|2.52|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.52|1.35|0.0001
74063180|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0161|TWO_SIDED|95.0|1.08|2.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.12|1.08|0.0161
74063181|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.3972|TWO_SIDED|95.0|0.76|2.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.00|0.76|0.3972
74063182|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.495|TWO_SIDED|95.0|0.5|1.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.39|0.50|0.4950
74063183|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0601|TWO_SIDED|95.0|0.99|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.94|0.99|0.0601
73888275|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.8048|TWO_SIDED|95.0|-3.9|5.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.0|-3.9|0.8048
73888276|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6||||0.0002|TWO_SIDED|95.0|4.2|13.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.1|4.2|0.0002
74063184|NCT01236053|147678201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.9286|TWO_SIDED|95.0|0.71|1.45|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.45|0.71|0.9286
74063185|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.5394|TWO_SIDED|95.0|0.63|2.39|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||2.39|0.63|0.5394
74063186|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.507|TWO_SIDED|95.0|0.39|1.58|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.58|0.39|0.5070
74063187|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.5426|TWO_SIDED|95.0|0.73|1.83|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||1.83|0.73|0.5426
74063188|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.515|TWO_SIDED|95.0|0.52|1.38|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.38|0.52|0.5150
74063189|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.435|TWO_SIDED|95.0|0.53|4.42|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||4.42|0.53|0.4350
74063190|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.8276|TWO_SIDED|95.0|0.37|3.43|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||3.43|0.37|0.8276
74063191|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.4022|TWO_SIDED|95.0|0.69|2.5|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||2.50|0.69|0.4022
74063192|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8681|TWO_SIDED|95.0|0.48|1.86|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.86|0.48|0.8681
74063193|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.6326|TWO_SIDED|95.0|0.2|13.86|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||13.86|0.20|0.6326
74063194|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.577|TWO_SIDED|95.0|0.21|16.86|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||16.86|0.21|0.5770
74063195|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.8087|TWO_SIDED|95.0|0.4|3.21|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||3.21|0.40|0.8087
74063196|NCT01236053|147678202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8497|TWO_SIDED|95.0|0.31|2.64|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.64|0.31|0.8497
74063197|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.1528|TWO_SIDED|95.0|0.88|2.24|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.24|0.88|0.1528
74063198|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.9625|TWO_SIDED|95.0|0.62|1.65|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.65|0.62|0.9625
74063199|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.48|2.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.59|1.48|<0.0001
74063200|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.0006|TWO_SIDED|95.0|1.25|2.29|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.29|1.25|0.0006
74063201|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.3515|TWO_SIDED|95.0|0.76|2.16|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.16|0.76|0.3515
74063202|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9069|TWO_SIDED|95.0|0.59|1.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.82|0.59|0.9069
74063203|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001|TWO_SIDED|95.0|1.78|3.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.21|1.78|<0.0001
74063204|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.0001|TWO_SIDED|95.0|1.48|2.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.81|1.48|<0.0001
74063205|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5948|TWO_SIDED|95.0|0.7|1.88|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.88|0.70|0.5948
74063206|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.3984|TWO_SIDED|95.0|0.47|1.35|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.35|0.47|0.3984
74063207|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.1872|TWO_SIDED|95.0|0.89|1.79|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.79|0.89|0.1872
74063208|NCT01236053|147678203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.6772|TWO_SIDED|95.0|0.64|1.34|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.34|0.64|0.6772
74063209|NCT01236053|147678204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.4933|TWO_SIDED|95.0|0.07|3.72|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||3.72|0.07|0.4933
74063210|NCT01236053|147678204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.4147|TWO_SIDED|95.0|0.06|3.27|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||3.27|0.06|0.4147
74063211|NCT01236053|147678205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.8257|TWO_SIDED|95.0|0.15|10.38|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||10.38|0.15|0.8257
74063212|NCT01236053|147678205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.9467|TWO_SIDED|95.0|0.13|9.02|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||9.02|0.13|0.9467
74063213|NCT01236053|147678205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9859|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||0.00|0.00|0.9859
74063214|NCT01236053|147678205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9857|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9857
74063215|NCT01236053|147678205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.986|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||0.00|0.00|0.9860
73882690|NCT01650558|147299378|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.51|||<=|0.05|TWO_SIDED|95.0|0.91|2.49||No adjustment for multiple comparisons was made.|Fisher Exact|||||2.49|0.91|<=0.05
74063216|NCT01236053|147678205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9858|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9858
74063217|NCT01236053|147678205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9798|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||0.00|0.00|0.9798
74063218|NCT01236053|147678205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9796|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9796
74063219|NCT01236053|147678206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.6252|TWO_SIDED|95.0|0.2|14.84|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||14.84|0.20|0.6252
74063220|NCT01236053|147678206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.7208|TWO_SIDED|95.0|0.17|13.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||13.28|0.17|0.7208
74063221|NCT01236053|147678208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.9141|TWO_SIDED|95.0|0.14|9.03|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||9.03|0.14|0.9141
74063222|NCT01236053|147678208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.9613|TWO_SIDED|95.0|0.12|7.78|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||7.78|0.12|0.9613
74063223|NCT01236053|147678209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0323|TWO_SIDED|95.0|1.02|1.57|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.57|1.02|0.0323
74063224|NCT01236053|147678209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0682|TWO_SIDED|95.0|0.99|1.52|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.52|0.99|0.0682
74063225|NCT01236053|147678209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0326|TWO_SIDED|95.0|1.01|1.4|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.40|1.01|0.0326
74063226|NCT01236053|147678209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0699|TWO_SIDED|95.0|0.99|1.36|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.36|0.99|0.0699
74063227|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.2893|TWO_SIDED|95.0|0.86|1.69|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.69|0.86|0.2893
74063228|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.4301|TWO_SIDED|95.0|0.82|1.61|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.61|0.82|0.4301
74063229|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.0806|TWO_SIDED|95.0|0.97|1.58|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.58|0.97|0.0806
74063230|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.1226|TWO_SIDED|95.0|0.95|1.55|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.55|0.95|0.1226
74063231|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.3502|TWO_SIDED|95.0|0.8|1.89|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.89|0.80|0.3502
74063232|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4654|TWO_SIDED|95.0|0.76|1.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.81|0.76|0.4654
74063233|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.3987|TWO_SIDED|95.0|0.59|1.23|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.23|0.59|0.3987
74063234|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.3349|TWO_SIDED|95.0|0.58|1.2|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.20|0.58|0.3349
73882691|NCT01650558|147299379|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.13|||<=|0.05|TWO_SIDED|95.0|0.66|1.93||No adjustments for multiple comparisons were made.|Fisher Exact|||||1.93|0.66|<=0.05
74063235|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0827|TWO_SIDED|95.0|0.96|1.98|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.98|0.96|0.0827
74063236|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0932|TWO_SIDED|95.0|0.95|1.96|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.96|0.95|0.0932
74063237|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.013|TWO_SIDED|95.0|1.07|1.8|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.80|1.07|0.0130
74063238|NCT01236053|147678210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.0241|TWO_SIDED|95.0|1.04|1.75|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.75|1.04|0.0241
74063239|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5043|TWO_SIDED|95.0|0.77|1.68|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.68|0.77|0.5043
74063240|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7129|TWO_SIDED|95.0|0.73|1.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.59|0.73|0.7129
74063241|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.2055|TWO_SIDED|95.0|0.91|1.57|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.57|0.91|0.2055
74063242|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.3005|TWO_SIDED|95.0|0.88|1.52|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.52|0.88|0.3005
74063243|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.2849|TWO_SIDED|95.0|0.84|1.77|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.77|0.84|0.2849
74063244|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.365|TWO_SIDED|95.0|0.82|1.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.72|0.82|0.3650
74063245|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.7559|TWO_SIDED|95.0|0.78|1.4|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.40|0.78|0.7559
74063246|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.852|TWO_SIDED|95.0|0.77|1.37|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.37|0.77|0.8520
74063247|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0459|TWO_SIDED|95.0|1.01|2.06|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.06|1.01|0.0459
74063248|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.0542|TWO_SIDED|95.0|0.99|2.04|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.04|0.99|0.0542
74063249|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.0312|TWO_SIDED|95.0|1.03|1.74|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.74|1.03|0.0312
74063250|NCT01236053|147678211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.0508|TWO_SIDED|95.0|1.0|1.7|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.70|1.00|0.0508
74063251|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0892|TWO_SIDED|95.0|0.94|2.42|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||2.42|0.94|0.0892
74063252|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1043|TWO_SIDED|95.0|0.92|2.39|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.39|0.92|0.1043
74063253|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0101|TWO_SIDED|95.0|1.1|2.06|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||2.06|1.10|0.0101
74063254|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.0186|TWO_SIDED|95.0|1.07|2.0|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.00|1.07|0.0186
74063255|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||0.1458|TWO_SIDED|95.0|0.83|3.43|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||3.43|0.83|0.1458
74063256|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1859|TWO_SIDED|95.0|0.79|3.29|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.29|0.79|0.1859
74063257|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0122|TWO_SIDED|95.0|1.13|2.72|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||2.72|1.13|0.0122
74063258|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0162|TWO_SIDED|95.0|1.1|2.67|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.67|1.10|0.0162
74063259|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.7573|TWO_SIDED|95.0|0.19|3.36|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||3.36|0.19|0.7573
74063260|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.7088|TWO_SIDED|95.0|0.18|3.21|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.21|0.18|0.7088
74063261|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0787|TWO_SIDED|95.0|0.93|3.64|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||3.64|0.93|0.0787
74063262|NCT01236053|147678212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0873|TWO_SIDED|95.0|0.92|3.58|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.58|0.92|0.0873
74063263|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4233|TWO_SIDED|95.0|0.8|1.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.70|0.80|0.4233
74063264|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5908|TWO_SIDED|95.0|0.76|1.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.62|0.76|0.5908
74063265|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.054|TWO_SIDED|95.0|1.0|1.67|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.67|1.00|0.0540
74063266|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.0939|TWO_SIDED|95.0|0.96|1.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.62|0.96|0.0939
74063267|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.214|TWO_SIDED|95.0|0.87|1.87|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.87|0.87|0.2140
74063268|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.294|TWO_SIDED|95.0|0.84|1.8|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.80|0.84|0.2940
74063269|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.8352|TWO_SIDED|95.0|0.71|1.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.32|0.71|0.8352
74063270|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.7809|TWO_SIDED|95.0|0.7|1.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.31|0.70|0.7809
74063271|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0921|TWO_SIDED|95.0|0.95|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.94|0.95|0.0921
74063272|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.1091|TWO_SIDED|95.0|0.94|1.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.92|0.94|0.1091
74063273|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.0564|TWO_SIDED|95.0|0.99|1.68|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.68|0.99|0.0564
74063274|NCT01236053|147678213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.0939|TWO_SIDED|95.0|0.96|1.63|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.63|0.96|0.0939
74063275|NCT01236053|147678214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.58||||0.3082|TWO_SIDED|95.0|0.31|41.71|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||41.71|0.31|0.3082
74063276|NCT01236053|147678214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.3999|TWO_SIDED|95.0|0.24|34.69|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||34.69|0.24|0.3999
74063277|NCT01236053|147678214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.7509|TWO_SIDED|95.0|0.16|12.52|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||12.52|0.16|0.7509
73888277|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|11.0|||<|0.0001|TWO_SIDED|95.0|6.5|15.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.4|6.5|<0.0001
74063278|NCT01236053|147678214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.6303|TWO_SIDED|95.0|0.18|17.07|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||17.07|0.18|0.6303
74063279|NCT01236053|147678215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
74063280|NCT01236053|147678215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
74063281|NCT01236053|147678215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
74063282|NCT01236053|147678215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.50|0.1118
74063283|NCT01236053|147678216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
74063284|NCT01236053|147678216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
74063285|NCT01236053|147678216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
74063286|NCT01236053|147678216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.50|0.1118
74063287|NCT01236053|147678218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
74063288|NCT01236053|147678218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
74063289|NCT01236053|147678218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
74063290|NCT01236053|147678218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.5|0.1118
74063291|NCT01236053|147678219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9614|TWO_SIDED|95.0|0.58|1.69|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.69|0.58|0.9614
74063292|NCT01236053|147678219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.5179|TWO_SIDED|95.0|0.49|1.44|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.44|0.49|0.5179
74063293|NCT01236053|147678219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8856|TWO_SIDED|95.0|0.71|1.48|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.48|0.71|0.8856
74063294|NCT01236053|147678219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.5078|TWO_SIDED|95.0|0.61|1.28|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.28|0.61|0.5078
74063295|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6888|TWO_SIDED|95.0|0.36|1.95|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.95|0.36|0.6888
74063296|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.5024|TWO_SIDED|95.0|0.32|1.75|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.75|0.32|0.5024
74063297|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6164|TWO_SIDED|95.0|0.49|1.53|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.53|0.49|0.6164
74063298|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4002|TWO_SIDED|95.0|0.44|1.39|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.39|0.44|0.4002
74063299|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.7329|TWO_SIDED|95.0|0.25|2.66|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.66|0.25|0.7329
74063300|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.5731|TWO_SIDED|95.0|0.22|2.33|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.33|0.22|0.5731
73882692|NCT01650558|147299379|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|0.96|||<=|0.05|TWO_SIDED|95.0|0.55|1.68||No adjustments for multiple comparisons were made.|Fisher Exact|||||1.68|0.55|<=0.05
73882693|NCT01650558|147299380|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.47|||<=|0.05|TWO_SIDED|95.0|1.07|2.0||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||2.00|1.07|<=0.05
73882694|NCT01650558|147299380|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.43|||<=|0.05|TWO_SIDED|95.0|1.04|1.96||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.96|1.04|<=0.05
73888278|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1||||0.0019|TWO_SIDED|95.0|2.7|11.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.6|2.7|0.0019
74063301|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.3762|TWO_SIDED|95.0|0.69|2.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.63|0.69|0.3762
74063302|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.582|TWO_SIDED|95.0|0.62|2.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.36|0.62|0.5820
74063303|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4782|TWO_SIDED|95.0|0.58|3.23|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.23|0.58|0.4782
74063304|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8998|TWO_SIDED|95.0|0.44|2.52|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.52|0.44|0.8998
74063305|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9308|TWO_SIDED|95.0|0.53|1.99|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.99|0.53|0.9308
74063306|NCT01236053|147678220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.5125|TWO_SIDED|95.0|0.41|1.56|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.56|0.41|0.5125
74063307|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.8655|TWO_SIDED|95.0|0.37|2.33|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.33|0.37|0.8655
74063308|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.6482|TWO_SIDED|95.0|0.32|2.05|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.05|0.32|0.6482
74063309|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9003|TWO_SIDED|95.0|0.53|1.76|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.76|0.53|0.9003
74063310|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.6|TWO_SIDED|95.0|0.46|1.56|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.56|0.46|0.6000
74063311|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.567|TWO_SIDED|95.0|0.27|2.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.06|0.27|0.5670
74063312|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.4353|TWO_SIDED|95.0|0.24|1.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.85|0.24|0.4353
74063313|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.8922|TWO_SIDED|95.0|0.56|1.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.95|0.56|0.8922
74063314|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8591|TWO_SIDED|95.0|0.5|1.77|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.77|0.50|0.8591
74063315|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4779|TWO_SIDED|95.0|0.58|3.23|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.23|0.58|0.4779
74063316|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8994|TWO_SIDED|95.0|0.44|2.52|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.52|0.44|0.8994
74063317|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.78|TWO_SIDED|95.0|0.57|2.12|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.12|0.57|0.7800
74063318|NCT01236053|147678221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6577|TWO_SIDED|95.0|0.44|1.67|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.67|0.44|0.6577
74063319|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.8111|TWO_SIDED|95.0|0.48|2.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.59|0.48|0.8111
74063320|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9104|TWO_SIDED|95.0|0.45|2.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.46|0.45|0.9104
74063321|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.5592|TWO_SIDED|95.0|0.68|2.07|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.07|0.68|0.5592
74063322|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8521|TWO_SIDED|95.0|0.6|1.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.85|0.60|0.8521
74063323|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.5529|TWO_SIDED|95.0|0.26|2.04|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.04|0.26|0.5529
74063324|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.6||||0.3275|TWO_SIDED|95.0|0.21|1.68|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.68|0.21|0.3275
74063325|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.73|TWO_SIDED|95.0|0.46|1.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.72|0.46|0.7300
74063326|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.4831|TWO_SIDED|95.0|0.41|1.53|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.53|0.41|0.4831
74063327|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.7693|TWO_SIDED|95.0|0.45|2.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.92|0.45|0.7693
74063328|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8189|TWO_SIDED|95.0|0.35|2.3|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.30|0.35|0.8189
74063329|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.98|TWO_SIDED|95.0|0.5|1.98|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.98|0.50|0.9800
74063330|NCT01236053|147678223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4944|TWO_SIDED|95.0|0.39|1.58|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.58|0.39|0.4944
74063331|NCT01236053|147678224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||220.5|1.81|0.0144
74063332|NCT01236053|147678224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.79||||0.0743|TWO_SIDED|95.0|0.79|147.0|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||147.0|0.79|0.0743
74063333|NCT01236053|147678225|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
74063334|NCT01236053|147678225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
74063335|NCT01236053|147678226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
74063336|NCT01236053|147678226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
74063337|NCT01236053|147678228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
74063338|NCT01236053|147678228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
74063339|NCT01236053|147678229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0066|TWO_SIDED|95.0|1.21|3.32|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||3.32|1.21|0.0066
74063340|NCT01236053|147678229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0494|TWO_SIDED|95.0|1.0|2.82|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.82|1.00|0.0494
74063341|NCT01236053|147678229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.0006|TWO_SIDED|95.0|1.33|2.82|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.82|1.33|0.0006
74063342|NCT01236053|147678229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.0138|TWO_SIDED|95.0|1.11|2.41|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.41|1.11|0.0138
74063343|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29||||0.0006|TWO_SIDED|95.0|1.66|6.53|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.53|1.66|0.0006
74063344|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.002|TWO_SIDED|95.0|1.5|6.05|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||6.05|1.50|0.0020
74063345|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.0013|TWO_SIDED|95.0|1.43|4.34|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.34|1.43|0.0013
74063346|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.008|TWO_SIDED|95.0|1.22|3.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.80|1.22|0.0080
74063347|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.8165|TWO_SIDED|95.0|0.2|3.61|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.61|0.20|0.8165
74063348|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.6624|TWO_SIDED|95.0|0.17|3.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.12|0.17|0.6624
74063349|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6316|TWO_SIDED|95.0|0.45|3.68|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.68|0.45|0.6316
74063350|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.906|TWO_SIDED|95.0|0.35|3.22|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.22|0.35|0.9060
74063351|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.3731|TWO_SIDED|95.0|0.61|3.74|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.74|0.61|0.3731
74063352|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.8266|TWO_SIDED|95.0|0.43|2.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.87|0.43|0.8266
74063353|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0712|TWO_SIDED|95.0|0.95|3.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.13|0.95|0.0712
74063354|NCT01236053|147678230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.2674|TWO_SIDED|95.0|0.77|2.6|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.60|0.77|0.2674
74063355|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.61||||0.0005|TWO_SIDED|95.0|1.75|7.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||7.46|1.75|0.0005
74063356|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.25||||0.0019|TWO_SIDED|95.0|1.55|6.83|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||6.83|1.55|0.0019
74063357|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.0024|TWO_SIDED|95.0|1.39|4.55|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.55|1.39|0.0024
74063358|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18||||0.0115|TWO_SIDED|95.0|1.19|4.0|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||4.00|1.19|0.0115
74063359|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.6281|TWO_SIDED|95.0|0.17|2.96|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.96|0.17|0.6281
74063360|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.5103|TWO_SIDED|95.0|0.14|2.62|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.62|0.14|0.5103
74063361|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.15||||0.7733|TWO_SIDED|95.0|0.45|2.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.90|0.45|0.7733
74063362|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.837|TWO_SIDED|95.0|0.43|2.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.81|0.43|0.8370
74063363|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.198|TWO_SIDED|95.0|0.75|4.1|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.10|0.75|0.1980
74063364|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.5391|TWO_SIDED|95.0|0.54|3.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.21|0.54|0.5391
74063365|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97||||0.0224|TWO_SIDED|95.0|1.1|3.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.53|1.10|0.0224
74063366|NCT01236053|147678231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.1815|TWO_SIDED|95.0|0.82|2.77|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.77|0.82|0.1815
74063367|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0248|TWO_SIDED|95.0|1.12|5.09|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.09|1.12|0.0248
74063368|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.052|TWO_SIDED|95.0|0.99|4.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||4.70|0.99|0.0520
74063369|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0046|TWO_SIDED|95.0|1.3|4.2|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.20|1.30|0.0046
74063370|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.0193|TWO_SIDED|95.0|1.12|3.72|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.72|1.12|0.0193
74063371|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.75||||0.0309|TWO_SIDED|95.0|1.1|6.88|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||6.88|1.10|0.0309
74063372|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||0.1285|TWO_SIDED|95.0|0.81|5.51|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||5.51|0.81|0.1285
74063373|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.1257|TWO_SIDED|95.0|0.85|3.83|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.83|0.85|0.1257
74063374|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.2944|TWO_SIDED|95.0|0.7|3.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.31|0.70|0.2944
74063375|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.7032|TWO_SIDED|95.0|0.45|3.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.21|0.45|0.7032
74063376|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9922|TWO_SIDED|95.0|0.37|2.69|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.69|0.37|0.9922
74063377|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.1227|TWO_SIDED|95.0|0.87|3.16|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.16|0.87|0.1227
74063378|NCT01236053|147678233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.3809|TWO_SIDED|95.0|0.69|2.61|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.61|0.69|0.3809
74063379|NCT01236053|147678234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.1757|TWO_SIDED|95.0|0.8|3.34|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||3.34|0.80|0.1757
74063380|NCT01236053|147678234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.4405|TWO_SIDED|95.0|0.64|2.75|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.75|0.64|0.4405
74063381|NCT01236053|147678234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.442|TWO_SIDED|95.0|0.71|2.16|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.16|0.71|0.4420
73888279|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6||||0.001|TWO_SIDED|95.0|3.2|12.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.1|3.2|0.0010
74063382|NCT01236053|147678234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.9034|TWO_SIDED|95.0|0.59|1.82|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||1.82|0.59|0.9034
74063383|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.2395|TWO_SIDED|95.0|0.65|5.6|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.60|0.65|0.2395
73888280|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|127.4|||<|0.0001|TWO_SIDED|95.0|93.6|161.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||161.2|93.6|<0.0001
74063384|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.3764|TWO_SIDED|95.0|0.55|4.93|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.93|0.55|0.3764
74063385|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.7599|TWO_SIDED|95.0|0.48|2.71|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.71|0.48|0.7599
74063386|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9502|TWO_SIDED|95.0|0.43|2.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.46|0.43|0.9502
74063387|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.7164|TWO_SIDED|95.0|0.3|5.75|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||5.75|0.30|0.7164
73888281|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7||||0.7837|TWO_SIDED|95.0|-29.1|38.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.5|-29.1|0.7837
74063388|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9345|TWO_SIDED|95.0|0.24|4.73|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.73|0.24|0.9345
74063389|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.8833|TWO_SIDED|95.0|0.28|3.02|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.02|0.28|0.8833
74063390|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.6178|TWO_SIDED|95.0|0.22|2.46|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.46|0.22|0.6178
74063391|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.4556|TWO_SIDED|95.0|0.46|5.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||5.53|0.46|0.4556
74063392|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.7478|TWO_SIDED|95.0|0.35|4.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.29|0.35|0.7478
74063393|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.235|TWO_SIDED|95.0|0.71|4.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||4.13|0.71|0.2350
74063394|NCT01236053|147678235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.5428|TWO_SIDED|95.0|0.54|3.24|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.24|0.54|0.5428
74063395|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.3123|TWO_SIDED|95.0|0.55|6.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.59|0.55|0.3123
74063396|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.3951|TWO_SIDED|95.0|0.49|6.15|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||6.15|0.49|0.3951
74063397|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.4388|TWO_SIDED|95.0|0.56|3.75|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.75|0.56|0.4388
74063398|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.5535|TWO_SIDED|95.0|0.51|3.47|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.47|0.51|0.5535
74063399|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.6332|TWO_SIDED|95.0|0.4|4.48|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.48|0.40|0.6332
74063400|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8743|TWO_SIDED|95.0|0.32|3.75|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.75|0.32|0.8743
74063401|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.6132|TWO_SIDED|95.0|0.27|2.15|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.15|0.27|0.6132
74063402|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.63||||0.3821|TWO_SIDED|95.0|0.22|1.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||1.78|0.22|0.3821
74063403|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.3591|TWO_SIDED|95.0|0.51|6.28|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||6.28|0.51|0.3591
73882695|NCT01650558|147299381|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.31|||<=|0.05|TWO_SIDED|95.0|1.11|1.55||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.55|1.11|<=0.05
73882696|NCT01650558|147299381|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.34|||<=|0.05|TWO_SIDED|95.0|1.14|1.58||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.58|1.14|<=0.05
73888282|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|65.8||||0.0002|TWO_SIDED|95.0|32.0|99.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||99.6|32.0|0.0002
73882697|NCT01069484|147299390|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on the study by Mørkved and Bø (1997), showing 67% prevalence reduction of UI in the PFMT group and 34% reduction in the control group. Assuming a similar effect, two-sided significance of \<0.05, and a power of 0.90, required a total of 62 women. Stratified analysis on major levator ani (LA) muscle defects was planned, but the effect of PFMT in women with such defects was unknown. The statistical advice was to aim for 80 women with- and 80 women without such defects.|Risk Ratio (RR)|0.89||||0.57|TWO_SIDED|95.0|0.6|1.32||P-values \< 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|"Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used."||1.32|0.60|0.57
74063404|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6899|TWO_SIDED|95.0|0.37|4.58|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.58|0.37|0.6899
73888283|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|66.3||||0.0002|TWO_SIDED|95.0|32.5|100.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||100.1|32.5|0.0002
74063405|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.2031|TWO_SIDED|95.0|0.73|4.3|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||4.30|0.73|0.2031
74063406|NCT01236053|147678236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4932|TWO_SIDED|95.0|0.56|3.37|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.37|0.56|0.4932
74063407|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64||||0.0843|TWO_SIDED|95.0|0.88|7.96|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||7.96|0.88|0.0843
74063408|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.71||||0.081|TWO_SIDED|95.0|0.88|8.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||8.28|0.88|0.0810
74063409|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.4583|TWO_SIDED|95.0|0.55|3.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.70|0.55|0.4583
74063410|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.4622|TWO_SIDED|95.0|0.55|3.73|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.73|0.55|0.4622
74063411|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.5512|TWO_SIDED|95.0|0.43|4.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.95|0.43|0.5512
74063412|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9277|TWO_SIDED|95.0|0.31|3.67|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.67|0.31|0.9277
74063413|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6402|TWO_SIDED|95.0|0.51|2.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.95|0.51|0.6402
74063414|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9256|TWO_SIDED|95.0|0.4|2.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.32|0.40|0.9256
74063415|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9514|TWO_SIDED|95.0|0.24|4.5|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.50|0.24|0.9514
74063416|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.7543|TWO_SIDED|95.0|0.18|3.44|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.44|0.18|0.7543
74063417|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.8781|TWO_SIDED|95.0|0.38|3.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.07|0.38|0.8781
74063418|NCT01236053|147678238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7429|TWO_SIDED|95.0|0.29|2.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.40|0.29|0.7429
74063419|NCT02340078|147678240|SUPERIORITY||Subjects % with difference in VAS ≥ 10mm|0.9516|||||TWO_SIDED|95.0|0.87|0.99||||||||0.99|0.87|
74063420|NCT01311505|147678242|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.9|||||TWO_SIDED|90.0|92.98|105.2||||||20 participants (10 per sequence) provided at least 98% power that 90% confidence interval (CI) for ratio of test to reference for AUC(0-t) of rifampicin lie within acceptance region of 80%-125%. Intra-participant coefficient of variation (CV) estimate of approximately 13.48% for AUC(0-t) was used for this power calculation. Natural log transformed AUC(0-t) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.||105.20|92.98|
74063421|NCT01311505|147678243|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.24|||||TWO_SIDED|90.0|87.77|109.97||||||20 participants (10 per sequence) provided at least 94% power that 90% CI for ratio of test to reference for Cmax of rifampicin lie within acceptance region of 80%-125%. Intra-participant CV estimate of approximately 16.43% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.||109.97|87.77|
74063422|NCT01311505|147678245|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.25|||||TWO_SIDED|90.0|94.44|106.41||||||Natural log transformed AUC(0-∞) of rifampicin was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||106.41|94.44|
74063423|NCT02524665|147678268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.67|STANDARD_DEVIATION|61.97||0.0769||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used|Wilcoxon signed-rank test||Comparison of inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.0769
74063424|NCT02524665|147678268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.77|STANDARD_DEVIATION|33.73||0.6698||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.6698
74063425|NCT02524665|147678268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.66|STANDARD_DEVIATION|17.59||0.6854||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of total lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.6854
74063426|NCT02524665|147678269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|74.55||0.5031||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.5031
74063427|NCT02524665|147678269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.11|STANDARD_DEVIATION|99.76||0.2464||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.2464
74063428|NCT02524665|147678269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03|STANDARD_DEVIATION|65.22||0.8894||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.8894
74063429|NCT02524665|147678269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.98|STANDARD_ERROR_OF_MEAN|46.04||0.6722||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.6722
74063430|NCT02524665|147678269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_DEVIATION|39.59||0.3352||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.3352
74063431|NCT02524665|147678269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41|STANDARD_DEVIATION|35.46||0.9323||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.9323
74063432|NCT02524665|147678269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72|STANDARD_DEVIATION|26.05||0.3513||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.3513
74063433|NCT02524665|147678269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|STANDARD_DEVIATION|22.97||0.8199||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.8199
74063434|NCT02524665|147678269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|17.83||0.9616||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.9616
73882698|NCT01069484|147299391|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.51|TWO_SIDED|95.0|0.49|1.42||P-values \< 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|"Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used."||1.42|0.49|0.51
74063435|NCT02524665|147678270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 1|||||1.0000
74063436|NCT02524665|147678270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.66||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 2.|||||0.7500
74063437|NCT02524665|147678270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.74||0.7539||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 4.|||||0.7539
73882699|NCT02732600|147299397|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.59||0.39|TWO_SIDED|95.0|-0.66|1.68|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||1.68|-0.66|0.39
74063438|NCT02524665|147678270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.87||0.3071||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 8|||||0.3071
74063439|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 1.|||||0.5000
74063440|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.52||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 2.|||||1.0000
74063441|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 4.|||||1.0000
74063442|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 8.|||||0
74063443|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.74||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.|||||1.0000
74063444|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.|||||0
74063445|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.|||||0
74063446|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.|||||1.0000
74063447|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 1.|||||1.0000
74063448|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 2.|||||0
74063449|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 4.|||||0
74063450|NCT02524665|147678271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 8.|||||1.0000
74063451|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|0.63||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 1.|||||0.5000
74063452|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 2.|||||0.5000
74063453|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.92||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 4.|||||1.0000
74063454|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_DEVIATION|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 8.|||||1.0000
74063455|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.88||0.8125||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.|||||0.8125
74063456|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.94||0.5742||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.|||||0.5742
74063457|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.|||||0.5000
74063458|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.|||||0.2500
74063459|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.62||1||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 1.|||||1.0000
73882700|NCT02732600|147299397|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.71||0.35|TWO_SIDED|95.0|-0.75|2.06|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||2.06|-0.75|0.35
73882701|NCT02732600|147299397|SUPERIORITY||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|0.81||0.21|TWO_SIDED|95.0|-0.57|2.6|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||2.60|-0.57|0.21
73882702|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|3.6||0.156|TWO_SIDED|95.0|-2.2|13.48|||t-test, 2 sided|||t-test used to compare group differences in Cohesiveness at BASELINE||13.48|-2.2|0.156
74063460|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 2.|||||0.7500
74063461|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.98||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 4.|||||0.7500
74063462|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.73||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 8.|||||0.2500
74063463|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.54||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 1.|||||0.2500
74063464|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 2.|||||0.7500
74063465|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_DEVIATION|1.01||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 4.|||||0.2500
74063466|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 8.|||||0.2500
74063467|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 1.|||||0.5000
74063468|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 2.|||||0
73882703|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|7.97|STANDARD_ERROR_OF_MEAN|5.89||0.182|TWO_SIDED|95.0|-3.85|19.8|||t-test, 2 sided|||t-test to compare group means on Communication at BASELINE||19.8|-3.85|0.182
73882704|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|8.41|STANDARD_ERROR_OF_MEAN|6.31||0.234|TWO_SIDED|95.0|-5.74|22.57|||t-test, 2 sided|||t-test to compare group differences on Role Clarity at BASELINE||22.57|-5.74|0.234
74063469|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 4.|||||0.5000
74063470|NCT02524665|147678272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.81||1||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 8.|||||1.0000
74063471|NCT02524665|147678273|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar|||||||1.0000
74063472|NCT02524665|147678273|SUPERIORITY_OR_OTHER|||||||0||95.0||||The value is mentioned as '0', as no P-value generated. Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar|||||||0
74063473|NCT02524665|147678273|SUPERIORITY_OR_OTHER|||||||0.5637||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar|||||||0.5637
74063474|NCT02524665|147678273|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar|||||||1.0000
74063475|NCT02524665|147678273|SUPERIORITY_OR_OTHER|||||||0.4795||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar|||||||0.4795
74063476|NCT02524665|147678273|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar|||||||1.0000
74063477|NCT02524665|147678273|SUPERIORITY_OR_OTHER|||||||0.3173||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar|||||||0.3173
74063478|NCT02524665|147678273|SUPERIORITY_OR_OTHER|||||||0.1573||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar|||||||0.1573
74063479|NCT00883129|147678347|SUPERIORITY_OR_OTHER|||||||0.24||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the FVC %-predicted. Covariates were %-predicted FVC, HRCT-defined extent of lung fibrosis in the lobe of maximum involvement, and terms for time-trend, treatment and treatment-time trend interactions.||||0.24
74063480|NCT00883129|147678347|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the FVC %-predicted for each treatment arm independently.||||<0.05
74063481|NCT00883129|147678347|SUPERIORITY_OR_OTHER|||||||0.55||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|||Based on the absolute difference between the value of FVC %-predicted at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the FVC %-predicted.||||0.55
74063482|NCT00883129|147678348|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the TLC %-predicted.||||>0.05
74063483|NCT00883129|147678349|SUPERIORITY_OR_OTHER||||||<|0.001||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the DLCO %-predicted.||||<0.001
74063484|NCT00883129|147678349|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the DLCO %-predicted for each treatment arm independently.||||>0.05
74063485|NCT00883129|147678350|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the Quantitative Lung Fibrosis Score for the whole lung (QLF-WL).||||>0.05
74063486|NCT00883129|147678351|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in dyspnea as measured by the Transitional Dyspnea Index Score.||||>0.05
74063487|NCT00883129|147678351|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for dyspnea using the Transitional Dyspnea Index Score for each treatment arm independently.||||<0.05
74063488|NCT00883129|147678353|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in modified Rodnan Skin Score (mRSS).||||>0.05
74063489|NCT00883129|147678353|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the modified Rodnan Skin Score for each treatment arm independently.||||<0.05
74063490|NCT00883129|147678353|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|||Based on the absolute difference between the value of the mRSS at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the mRSS.||||>0.05
73882705|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|14.14|STANDARD_ERROR_OF_MEAN|9.63||0.149|TWO_SIDED|95.0|-5.22|33.5|||t-test, 2 sided|||t-test to compare group values on Goals at Baseline||33.5|-5.22|0.149
74063491|NCT00883129|147678354|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|The threshold for statistical significance was met only for the frequency of leukopenia and thrombocytopenia, but not for total SAE or death.||Fisher's Exact Test was utilized to compare the number of participants with a protocol-defined adverse event of interest, SAE or death between the MMF and CYC treatment arms.||||<0.05
74063492|NCT00883129|147678355|SUPERIORITY_OR_OTHER|||||||0.019||||||The threshold for statistical significance was a P-Value of \</=0.05.|Log Rank|||A log-rank test was utilized to assess differences between the MMF and CYC treatment arms with respect to the time to withdrawal from study drug or meeting protocol-defined criteria for treatment failure.||||0.019
74063493|NCT03273257|147678356|SUPERIORITY|||||||0.139|||||||2-sample Wilcoxon rank sum test|||The null hypothesis is that there is no difference between the treatment groups in percent change from baseline in PVR immediately before PEA.||||0.139
74063494|NCT04355767|147678382|SUPERIORITY|||||||||||||||||Analysis is of patients with a disease-progression event. The trial required a sample size of 900 patients to detect an absolute between-group difference of 10 percentage points (the minimum difference that we considered to be clinically important) with a power of 85%.|A Bayesian framework was used to calculate a risk difference of 1.9 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -6.0 to 9.8. The posterior probability of superiority was calculated to be 0.68. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.|||
74063495|NCT04355767|147678382|SUPERIORITY||Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-5.9|10.4|||||Risk difference after adjustment for age, sex, symptom duration.|Analysis is of patients with a disease-progression event.||10.4|-5.9|
74063496|NCT04355767|147678383|SUPERIORITY|||||||||||||||||Analysis is of patients with a disease-progression event.|A Bayesian framework was used to calculate a risk difference of 3.0 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -4.9 to 10.8. The posterior probability of superiority was calculated to be 0.76. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.|||
73882706|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|7.1||0.947|TWO_SIDED|95.0|-14.7|13.8|||t-test, 2 sided|||t-test of differences between groups on Cohesiveness at 6-Months||13.8|-14.7|0.947
73882707|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|8.4||0.87|TWO_SIDED|95.0|-15.6|18.4|||t-test, 2 sided|||t-test of groups differences on Communication at 6 Months||18.4|-15.6|0.870
73882708|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|6.18|STANDARD_ERROR_OF_MEAN|8.62||0.478|TWO_SIDED|95.0|-11.26|23.63|||t-test, 2 sided|||t-test of group differences on Role Clarity at 6 months||23.63|-11.26|0.478
74063497|NCT04355767|147678385|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
74063498|NCT04355767|147678386|OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.4|1.1||||||||1.1|-0.4|
74063499|NCT02200614|147678397|SUPERIORITY||Hazard Ratio (HR)|0.413|||<|1e-06|TWO_SIDED|95.0|0.341|0.5|||Log Rank||Hazard ratio and 95% Confidence Interval (CI) was based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.500|0.341|<0.000001
74063500|NCT02200614|147678398|SUPERIORITY||Hazard Ratio (HR)|0.706||||0.04521|TWO_SIDED|95.0|0.501|0.994|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.994|0.501|0.045210
74063501|NCT02200614|147678399|SUPERIORITY||Hazard Ratio (HR)|0.647||||8e-06|TWO_SIDED|95.0|0.533|0.785|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.785|0.533|0.000008
73882709|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_ERROR_OF_MEAN|7.71||0.773|TWO_SIDED|95.0|-13.35|17.83|||t-test, 2 sided|||t-test of group differences on Goals at 6 Months||17.83|-13.35|0.773
73882710|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|9.09|STANDARD_ERROR_OF_MEAN|9.8||0.498|TWO_SIDED|95.0|-20.4|38.6|||t-test, 2 sided|||t-test of group differences on Cohesiveness at 1year||38.6|-20.4|0.498
73882711|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|11.4||0.78|TWO_SIDED|95.0|-20.3|26.7|||t-test, 2 sided|||t-test of group differences on Communication at 1 year||26.7|-20.3|0.780
73882712|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|11.46|STANDARD_ERROR_OF_MEAN|12.54||0.474|TWO_SIDED|95.0|-23.19|46.11|||t-test, 2 sided|||t-test of group differences on Role Clarity at 1 year||46.11|-23.19|0.474
74063502|NCT02200614|147678400|SUPERIORITY||Hazard Ratio (HR)|0.433|||<|1e-06|TWO_SIDED|95.0|0.314|0.595|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.595|0.314|<0.000001
74063503|NCT02200614|147678401|SUPERIORITY||Hazard Ratio (HR)|0.428||||0.011262|TWO_SIDED|95.0|0.218|0.842|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.842|0.218|0.011262
74063504|NCT02200614|147678402|SUPERIORITY||Hazard Ratio (HR)|0.685||||0.003048|TWO_SIDED|95.0|0.533|0.881|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.881|0.533|0.003048
74063505|NCT02200614|147678403|SUPERIORITY||Hazard Ratio (HR)|0.647||||8e-06|TWO_SIDED|95.0|0.533|0.785|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.785|0.533|0.000008
74063506|NCT02200614|147678404|SUPERIORITY||Hazard Ratio (HR)|0.579||||4.4e-05|TWO_SIDED|95.0|0.444|0.755|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.755|0.444|0.000044
74063507|NCT02200614|147678405|SUPERIORITY||Hazard Ratio (HR)|0.484||||0.005294|TWO_SIDED|95.0|0.287|0.815|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.815|0.287|0.005294
74063508|NCT00759759|147678437|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|90.46||||||90.0|82.9|98.7|||ANOVA|||ANOVA of ln-transformed plasma morphine Cmax||98.7|82.9|
74063509|NCT00759759|147678439|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA performed on the ratio of geometric means|mean ratio|101.1||||||90.0|96.9|105.4|||ANOVA|||Statistical analysis of ln-transformed plasma morphine AUClast||105.4|96.9|
74063510|NCT00759759|147678440|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.3||||||90.0|96.2|106.7|||ANOVA|||||106.7|96.2|
74063511|NCT00301873|147678452|SUPERIORITY_OR_OTHER||Slope|-0.107|STANDARD_ERROR_OF_MEAN|0.0855||0.2212||95.0||||The p-value is a test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline baseline steroid use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 6 months using linear regression.||||.2212
74063512|NCT00301873|147678452|SUPERIORITY_OR_OTHER||Slope|0.2357|STANDARD_ERROR_OF_MEAN|0.1091||0.0413||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline anticonvulsant use and bone mass density at 6 months using linear regression||||.0413
73882713|NCT02732600|147299398|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|8.78||0.267|TWO_SIDED|95.0|-8.21|28.21|||t-test, 2 sided|||t-test of group differences on Goals at 1 year||28.21|-8.21|0.267
74063513|NCT00301873|147678452|SUPERIORITY_OR_OTHER||Slope|-0.232|STANDARD_ERROR_OF_MEAN|0.1029||0.0418||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline steroid use and BMD change at 12 months (outcome).||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 12 months using linear regression||||.0418
74063514|NCT00301873|147678452|SUPERIORITY_OR_OTHER||Slope|0.2123|STANDARD_ERROR_OF_MEAN|0.1209||0.1026||95.0||||the p-value is a test of whether the slope ofl the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 12 months.||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline anti-convulsant use and bone mass density at 12 months using linear regression||||.1026
74063515|NCT01211613|147678480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|14.0||0.009|TWO_SIDED|95.0||||The p value above relates to the comparison of differences in baseline/4-week Oswestry change scores between manual and mechanical manipulation methods (primary hypothesis). A priori threshold for statistical significance was set at p \< 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Oswestry score, age, and treatment expectancy.||||||0.009
74063516|NCT01211613|147678481|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||The p value above relates to the comparison of differences in baseline/4-week Numeric pain change scores between manual and mechanical manipulation methods (secondary hypothesis). A priori threshold for statistical significance was set at p \< 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Numeric pain score, age, and treatment expectancy.||||||0.002
74063517|NCT03853213|147678482|SUPERIORITY||Mean difference (in change score)|2.54||||0.698|TWO_SIDED|95.0|-11.62|16.71|||t-test, 2 sided|The p-value is adjusted using the Satterthwaite correction due to unequal variances between the two groups.|A higher value of the estimation parameter of mean difference in change score indicates a greater reduction in the measure for the intervention group relative to the attention control group.|||16.71|-11.62|0.698
74063518|NCT03853213|147678483|SUPERIORITY||Mean Difference (Final Values)|-3.88||||0.123|TWO_SIDED|95.0|-9.0|1.24|||t-test, 2 sided||A lower value of the estimation parameter of mean difference indicates lower extent of medication nonadherence for the intervention relative to the control group.|Note that the measure of extent of medication nonadherence used the older 5-item version of the scale rather than the newer 3-item version of the scale because the IRB modification to change the measure took effect after the majority of participants who provided data for Visit 2 had completed the measure.||1.24|-9.00|0.123
74063519|NCT03853213|147678484|SUPERIORITY||Mean difference (in change score)|66.29||||0.965|TWO_SIDED|95.0|-3081.7|3214.3|||t-test, 2 sided|||||3214.3|-3081.7|0.965
74063520|NCT03853213|147678485|SUPERIORITY||Mean difference (in change score)|-6.17||||0.29|TWO_SIDED|95.0|-18.15|5.81|||t-test, 2 sided||A higher value of the estimation parameter of mean difference in change score indicates a greater increase in context sensitivity for the intervention group relative to the attention control group.|||5.81|-18.15|0.290
73882714|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.38||0.098|TWO_SIDED|95.0|-0.09|1.0|||t-test, 2 sided|||t test comparison across groups on CORE PEER at 6 months||1.00|-0.09|0.098
74063521|NCT03853213|147678486|SUPERIORITY||Mean difference (in change score)|-5.07||||0.434|TWO_SIDED|95.0|-18.51|8.38|||t-test, 2 sided||A higher value of the estimation parameter of mean difference in change score indicates a greater increase in future time perspective for the intervention group relative to the attention control group.|||8.38|-18.51|0.434
74063522|NCT03853213|147678487|SUPERIORITY||Mean Difference (Final Values)|17.05||||0.293|TWO_SIDED|95.0|-19.07|53.17|||t-test, 2 sided||A higher value of the estimation parameter of mean difference indicates a lower extent of objectively measured medication adherence for the intervention relative to the control group.|||53.17|-19.07|0.293
74063523|NCT00297492|147678512|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Statistical significance was determined by a two-sided p value less than 0.05.|Chi-squared|Degrees of freedom = 2||"Null hypothesis: prolonged abstinence from smoking is the same for the three groups at 6 month follow-up~Sample size was based on an assumption of 6 month abstinence of 25% in the gradual group, 15% in the abrupt group, and 10% in the minimal group. Sample sizes of 300, 300, and 150 for gradual, abrupt, and minimal provides 97% to detect a difference between the groups, with 2-sided alpha = 0.05."||||0.30
74063524|NCT00297492|147678512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.28|1.22|||||The reported odds ratio represents the odds of 6 month prolonged abstinence in the gradual reduction group divided by the odds of 6 month prolonged abstinence in the abrupt cessation group.|||1.22|0.28|
74063525|NCT02437890|147678522|SUPERIORITY||||||=|0.526||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: linear model"||||= 0.526
74063526|NCT02437890|147678522|SUPERIORITY||||||=|0.504||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: Emax model"||||= 0.504
74063527|NCT02437890|147678522|SUPERIORITY||||||=|0.548||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: logistic model"||||= 0.548
74063528|NCT02437890|147678522|SUPERIORITY||||||=|0.985||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 1st Beta model"||||= 0.985
74063529|NCT02437890|147678522|SUPERIORITY||||||=|0.524||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 2nd Beta model"||||= 0.524
74063530|NCT02414854|147678563|SUPERIORITY|Hierarchical testing procedure was used to control type I error rate at 0.05 level. The procedure included the 2 primary outcome measures and the first 13 secondary outcome measures reported and considered 2 pair-wise comparisons: Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w and Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w. Testing order is specified in analysis description.|Relative risk|0.54|||<|0.0001|TWO_SIDED|95.0|0.43|0.68||Hierarchical testing sequence performed continued only when previous outcome measures was statistically significant at 0.05. Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 1 of testing order.||0.68|0.43|<0.0001
74063531|NCT02414854|147678563|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.523|||<|0.0001|TWO_SIDED|95.0|0.413|0.662||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 3 of testing order.||0.662|0.413|<0.0001
74063532|NCT02414854|147678564|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Least Square (LS) Mean Difference|0.13|||<|0.0001|TWO_SIDED|95.0|0.08|0.18||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using mixed-effect model with repeated measures (MMRM) model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 2 of testing order.||0.18|0.08|<0.0001
74063533|NCT02414854|147678564|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.14|||<|0.0001|TWO_SIDED|95.0|0.08|0.19||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 4 of testing order.||0.19|0.08|<0.0001
74063534|NCT02414854|147678565|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|9.41|||<|0.0001|TWO_SIDED|95.0|5.74|13.07||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis performed using MMRM model(n=954 for 300 vs placebo)with percent change from baseline in FEV1 values up to Week 12 as response variable; \& treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value \& baseline-by-visit interaction as covariates. Hierarchical testing procedure used to control type I error \& handle multiple secondary endpoint analyses. Here, it is test no. 5 of testing order.||13.07|5.74|<0.0001
74063535|NCT02414854|147678566|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.402|||<|0.0001|TWO_SIDED|95.0|0.307|0.526||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 6 of testing order.||0.526|0.307|<0.0001
74063536|NCT02414854|147678567|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.21||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 7 of testing order.||0.21|0.09|<0.0001
74063537|NCT02414854|147678568|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.326|||<|0.0001|TWO_SIDED|95.0|0.234|0.454||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 8 of testing order.||0.454|0.234|<0.0001
74063538|NCT02414854|147678569|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.32||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 9 of testing order.||0.32|0.16|<0.0001
74063539|NCT02414854|147678570|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.834||||0.2599|TWO_SIDED|95.0|0.608|1.144||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 10 of testing order.||1.144|0.608|0.2599
74063540|NCT00606801|147678608|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.006
74063541|NCT00606801|147678609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.04
74063542|NCT00606801|147678610|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.02
74063543|NCT00606801|147678611|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.03
74063544|NCT00606801|147678612|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.5
74063545|NCT00606801|147678613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.7
74063546|NCT00606801|147678614|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
74063547|NCT00606801|147678615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
73882715|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.1||0.282|TWO_SIDED|95.0|-0.43|1.43|||t-test, 2 sided|||t-test comparison across groups on COLLABORATION at 6 months||1.43|-0.43|0.282
73882716|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.56||0.06|TWO_SIDED|95.0|-0.05|2.29|||t-test, 2 sided|||t-test comparison across groups on PEER SPECIALIST AS LIAISON at 6 months||2.29|-0.05|0.06
73882717|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.86||0.34|TWO_SIDED|95.0|0.07|1.59|||t-test, 2 sided|||t-test comparison across groups on PROVIDES INFO ON SERVICES at 6 months||1.59|0.07|0.34
73882718|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.34|TWO_SIDED|95.0|-0.94|2.62|||t-test, 2 sided|||t-test comparison across groups on Symptoms and Medication at 6-months||2.62|-0.94|0.34
73882719|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.64||0.66|TWO_SIDED|95.0|-1.03|1.5|||t-test, 2 sided|||t-test comparison across groups on Training and Preparation at 6-months||1.50|-1.03|0.66
73882720|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.61||0.15|TWO_SIDED|95.0|-0.36|2.16|||t-test, 2 sided|||t-test comparison across groups on Team Integration and Relationships at 6 Months||2.16|-0.36|0.15
73882721|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.39||0.59|TWO_SIDED|95.0|-1.01|0.59|||t-test, 2 sided|||t-test comparison across groups on Leadership at 6-months||0.59|-1.01|0.59
73882722|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.84||0.95|TWO_SIDED|95.0|-1.77|1.68|||t-test, 2 sided|||t-test comparison across groups on Fits to Experience at 6 months||1.68|-1.77|0.95
73882723|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.55||0.32|TWO_SIDED|95.0|-0.58|1.68|||t-test, 2 sided|||t-test comparison across groups on Role Clarity at 6 months||1.68|-0.58|0.32
74063548|NCT00606801|147678616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
74063549|NCT00606801|147678617|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.9
73882724|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|0.64||0.27|TWO_SIDED|95.0|-0.6|2.04|||t-test, 2 sided|||t-test comparison across both groups on Resources at 6 months||2.04|-0.60|0.27
73882725|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.86||0.93|TWO_SIDED|95.0|-1.71|1.85|||t-test, 2 sided|||t-test comparison across groups on Performance Reviews at 6 months||1.85|-1.71|0.93
73882726|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.32||0.15|TWO_SIDED|95.0|-1.45|-0.005|||t-test, 2 sided|||t-test comparison across groups on CORE PEER at 1 year||-0.005|-1.45|0.15
73882727|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.45||0.04|TWO_SIDED|95.0|-1.7|0.32|||t-test, 2 sided|||t-test comparison across groups on Collaboration at 1 year||0.32|-1.7|0.04
73882728|NCT02732600|147299399|SUPERIORITY||Hazard Ratio, log|-0.95|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-2.07|0.17|||t-test, 2 sided|||t-test comparison across groups on Peer Specialists as Liaison at 1 year||0.17|-2.07|0.08
73882729|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.26|TWO_SIDED|95.0|-0.58|0.18|||t-test, 2 sided|||t-test comparison across groups on Provides Info on Services at 1 year||0.18|-0.58|0.26
73882730|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.65||0.61|TWO_SIDED|95.0|-4.53|2.83|||t-test, 2 sided|||t-test comparison between groups on Symptoms and Medication at 1 year||2.83|-4.53|0.61
73882731|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.87||0.3|TWO_SIDED|95.0|-2.87|1.01|||t-test, 2 sided|||t-test comparison across groups on Training and Preparation at 1 year||1.01|-2.87|0.30
73882732|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.35||0.004|TWO_SIDED|95.0|-2.08|-0.52|||t-test, 2 sided|||t-test comparison across groups on Team Integration and Relationships at 1 year||-0.52|-2.08|0.004
73882733|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.81||0.01|TWO_SIDED|95.0|-4.2|-0.6|||t-test, 2 sided|||t-test comparison across groups on Leadership at 1 year||-0.60|-4.20|0.01
73882734|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.9|TWO_SIDED|95.0|-24.1|23.5|||t-test, 2 sided|||t-test comparison across groups on Fits to Experience at 1 year||23.5|-24.1|0.90
73882735|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.7||0.06|TWO_SIDED|95.0|-3.02|0.12|||t-test, 2 sided|||t-test comparison across groups on Role Clarity at 1 year||0.12|-3.02|0.06
74063550|NCT00606801|147678618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.8
74063551|NCT00606801|147678619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.5
74063552|NCT00606801|147678620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.01
74063553|NCT00606801|147678621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.60
74063554|NCT00606801|147678622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.50
74063555|NCT02625207|147678642|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|116.73||||0.1318|TWO_SIDED|90.0|98.55|138.26|||Mixed Models Analysis|||||138.26|98.55|0.1318
74063556|NCT02625207|147678642|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|85.85||||0.1369|TWO_SIDED|90.0|72.48|101.68|||Mixed Models Analysis|||||101.68|72.48|0.1369
74063557|NCT02625207|147678642|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|63.38|||<|0.0001|TWO_SIDED|90.0|53.51|75.07|||Mixed Models Analysis|||||75.07|53.51|< 0.0001
74063558|NCT02625207|147678642|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|73.83||||0.0036|TWO_SIDED|90.0|62.57|87.13|||Mixed Models Analysis|||||87.13|62.57|0.0036
74063559|NCT02625207|147678642|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|73.99||||0.0038|TWO_SIDED|90.0|62.7|87.31|||Mixed Models Analysis|||||87.31|62.70|0.0038
74063560|NCT02625207|147678643|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|82.59||||0.0531|TWO_SIDED|90.0|70.33|96.98|||Mixed Models Analysis|||||96.98|70.33|0.0531
74063561|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|137.07||||0.0106|TWO_SIDED|90.0|112.4|167.15|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||167.15|112.40|0.0106
74063562|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|164.06||||0.0001|TWO_SIDED|90.0|134.54|200.06|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||200.06|134.54|0.0001
74063563|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|198.49|||<|0.0001|TWO_SIDED|90.0|162.77|242.05|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||242.05|162.77|< 0.0001
74063564|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|120.99||||0.1061|TWO_SIDED|90.0|99.65|146.9|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||146.90|99.65|0.1061
74063565|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|272.07|||<|0.0001|TWO_SIDED|90.0|224.08|330.33|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||330.33|224.08|<0.0001
74063566|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|110.22||||0.3081|TWO_SIDED|90.0|94.05|129.18|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||129.18|94.05|0.3081
74063567|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|101.71||||0.8583|TWO_SIDED|90.0|86.79|119.2|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||119.20|86.79|0.8583
74063568|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|108.52||||0.3913|TWO_SIDED|90.0|92.6|127.17|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||127.17|92.60|0.3913
74063569|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|106.69||||0.4866|TWO_SIDED|90.0|91.36|124.6|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||124.60|91.36|0.4866
74063570|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|119.61||||0.059|TWO_SIDED|90.0|102.42|139.69|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||139.69|102.42|0.0590
74063571|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.7||||0.9816|TWO_SIDED|90.0|80.47|123.53|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||123.53|80.47|0.9816
74063572|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|105.12||||0.6974|TWO_SIDED|90.0|84.84|130.24|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||130.24|84.84|0.6974
74063573|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|101.03||||0.9363|TWO_SIDED|90.0|81.54|125.18|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||125.18|81.54|0.9363
74063574|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|96.11||||0.752|TWO_SIDED|90.0|77.94|118.52|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||118.52|77.94|0.7520
73882736|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.53||0.71|TWO_SIDED|95.0|-0.97|1.37|||t-test, 2 sided|||t-test comparison across groups on Resources at 1 year||1.37|-0.97|0.71
73882737|NCT02732600|147299399|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.63||0.41|TWO_SIDED|95.0|-5.03|2.23|||t-test, 2 sided|||t-test comparison on Performance Reviews at 1 year||2.23|-5.03|0.41
74063575|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|100.73||||0.9536|TWO_SIDED|90.0|81.69|124.22|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||124.22|81.69|0.9536
74063576|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|97.6||||0.8241|TWO_SIDED|90.0|81.28|117.18|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||117.18|81.28|0.8241
74063577|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|118.5||||0.1261|TWO_SIDED|90.0|98.69|142.28|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||142.28|98.69|0.1261
74063578|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.6||||0.9708|TWO_SIDED|90.0|82.95|119.59|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||119.59|82.95|0.9708
74063579|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|84.05||||0.1099|TWO_SIDED|90.0|70.29|100.52|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||100.52|70.29|0.1099
74063580|NCT02625207|147678644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|97.21||||0.7913|TWO_SIDED|90.0|81.29|116.25|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||116.25|81.29|0.7913
74063581|NCT02625207|147678645|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|116.65||||0.1338|TWO_SIDED|90.0|98.47|138.18|||Mixed Models Analysis|||||138.18|98.47|0.1338
74063582|NCT02625207|147678645|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|85.84||||0.137|TWO_SIDED|90.0|72.46|101.68|||Mixed Models Analysis|||||101.68|72.46|0.1370
74063583|NCT02625207|147678645|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|63.34|||<|0.0001|TWO_SIDED|90.0|53.47|75.04|||Mixed Models Analysis|||||75.04|53.47|< 0.0001
74063584|NCT02625207|147678645|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|73.79||||0.0036|TWO_SIDED|90.0|62.53|87.09|||Mixed Models Analysis|||||87.09|62.53|0.0036
74063585|NCT02625207|147678645|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|73.89||||0.0037|TWO_SIDED|90.0|62.61|87.2|||Mixed Models Analysis|||||87.20|62.61|0.0037
74063586|NCT02625207|147678646|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|82.42||||0.0507|TWO_SIDED|90.0|70.2|96.77|||Mixed Models Analysis|||||96.77|70.20|0.0507
74063587|NCT02625207|147678647|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|118.19||||0.1997|TWO_SIDED|90.0|95.26|146.63|||Mixed Models Analysis|||||146.63|95.26|0.1997
74063588|NCT02625207|147678647|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|87.28||||0.2947|TWO_SIDED|90.0|70.34|108.28|||Mixed Models Analysis|||||108.28|70.34|0.2947
73882738|NCT02732600|147299400|SUPERIORITY||Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.17||0.002|TWO_SIDED|95.0|1.29|5.88||not adjusted for multiple comparisons|t-test, 2 sided|||Group Comparison at Baseline||5.88|1.29|0.002
74063589|NCT02625207|147678647|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|61.23||||0.0004|TWO_SIDED|90.0|49.35|75.97|||Mixed Models Analysis|||||75.97|49.35|0.0004
74063590|NCT02625207|147678647|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|70.16||||0.0071|TWO_SIDED|90.0|56.81|86.63|||Mixed Models Analysis|||||86.63|56.81|0.0071
74063591|NCT02625207|147678647|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|72.37||||0.0135|TWO_SIDED|90.0|58.6|89.36|||Mixed Models Analysis|||||89.36|58.60|0.0135
74063592|NCT02625207|147678648|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|68.32||||0.0505|TWO_SIDED|90.0|49.81|93.71|||Mixed Models Analysis|||||93.71|49.81|0.0505
74063593|NCT02625207|147678649|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|94.83||||0.6761|TWO_SIDED|90.0|76.7|117.24|||Mixed Models Analysis|||||117.24|76.70|0.6761
74063594|NCT02625207|147678649|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|105.43||||0.6771||90.0|85.28|130.35|||Mixed Models Analysis|||||130.35|85.28|0.6771
74063595|NCT02625207|147678649|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|75.74||||0.0331|TWO_SIDED|90.0|61.26|93.64|||Mixed Models Analysis|||||93.64|61.26|0.0331
74063596|NCT02625207|147678649|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|71.84||||0.0104|TWO_SIDED|90.0|58.38|88.4|||Mixed Models Analysis|||||88.40|58.38|0.0104
74063597|NCT02625207|147678649|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|71.82||||0.0104|TWO_SIDED|90.0|58.37|88.39|||Mixed Models Analysis|||||88.39|58.37|0.0104
74063598|NCT02625207|147678650|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.62||||0.9713|TWO_SIDED|90.0|83.07|119.45|||Mixed Models Analysis|||||119.45|83.07|0.9713
74063599|NCT00802529|147678685|SUPERIORITY_OR_OTHER|||||||0.271||||||P-value for Drug x Time interaction.|ANOVA|Time: 2 degrees of freedom (Baseline vs 18-24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.271
74063600|NCT00802529|147678686|SUPERIORITY_OR_OTHER|||||||0.964||||||P-value for Drug x Time interaction.|ANOVA|Time: 6 degrees of freedom (Baseline, 1, 2, 6, 12, 18 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.964
74063601|NCT00802529|147678687|SUPERIORITY_OR_OTHER|||||||0.128||||||P-value for Drug x Time interaction.|ANOVA|Time: 5 degrees of freedom (Baseline, 1, 2, 6, 12 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.128
73882739|NCT02732600|147299400|SUPERIORITY||Mean Difference (Final Values)|2.62|STANDARD_ERROR_OF_MEAN|1.6||0.1|TWO_SIDED|95.0|-0.54|5.78|||t-test, 2 sided|||Group Comparison at 6 Months||5.78|-0.54|0.10
73882740|NCT02732600|147299400|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.83||0.77|TWO_SIDED|95.0|-3.06|4.14|||t-test, 2 sided|||Group Comparison at 1 year||4.14|-3.06|0.77
73882741|NCT02732600|147299401|SUPERIORITY||Mean Difference (Final Values)|3.47|STANDARD_ERROR_OF_MEAN|1.56||0.02|TWO_SIDED|95.0|0.56|6.38||p value for 1st year only|t-test, 2 sided|||||6.38|0.56|0.02
73882742|NCT02732600|147299401|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|2.39||0.93|TWO_SIDED|95.0|-4.67|5.04|||t-test, 2 sided|||||5.04|-4.67|0.93
73882743|NCT02732600|147299402|SUPERIORITY||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|0.2||0.0001|TWO_SIDED|95.0|0.68|1.37|||t-test, 2 sided|p value for 1st year||||1.37|0.68|0.0001
73882744|NCT02732600|147299403|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|2.26||0.02|TWO_SIDED|95.0|1.46|9.96|||t-test, 2 sided|||||9.96|1.46|0.02
73882745|NCT02732600|147299403|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.92||0.38|TWO_SIDED|95.0|-3.14|8.54|||t-test, 2 sided|||||8.54|-3.14|0.38
73882746|NCT02732600|147299404|SUPERIORITY||Mean Difference (Final Values)|-99.4|STANDARD_ERROR_OF_MEAN|41.73||0.027|TWO_SIDED|95.0|-186.2|-12.66|||t-test, 2 sided|||||-12.66|-186.2|0.027
73882747|NCT02732600|147299405|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|0.28|0.92|||t-test, 2 sided|||||0.92|0.28|0.001
73888284|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|60.3||||0.0006|TWO_SIDED|95.0|26.5|94.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||94.1|26.5|0.0006
73888285|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|31.9||||0.064|TWO_SIDED|95.0|-1.9|65.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||65.7|-1.9|0.0640
74063602|NCT00337129|147678699|SUPERIORITY_OR_OTHER||Response probability|0.05|||||TWO_SIDED|95.0|0.01|0.17|||two-stage binomial|||Null hypothesis: response probability \< 5%; alternative hypothesis: response probability \> 20%. A two-stage design was used. If no responses among the first 20 patients, the study would be terminated with the conclusion that E7389 is inactive. However, if at least one response was seen then an additional 20 patients would be accrued. Five or more responses out of 40 would be considered evidence that E7389 warranted further study. This design had a significance level of 5% and a power of 92%.||0.17|0.01|
74063603|NCT00563524|147678729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5237|||||||ANCOVA|||Baseline: Analysis of covariance (ANCOVA) with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.5237
74063604|NCT00563524|147678729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8463|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.8463
74063605|NCT00563524|147678729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4596|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4596
74063606|NCT00563524|147678729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6345|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.6345
73888286|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|142.6|||<|0.0001|TWO_SIDED|95.0|94.5|190.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||190.7|94.5|<0.0001
73888287|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.5169|TWO_SIDED|95.0|-32.3|63.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||63.9|-32.3|0.5169
74063607|NCT00563524|147678729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6235|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.6235
74063608|NCT00563524|147678730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3833|||||||ANCOVA|||Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.3833
74063609|NCT00563524|147678730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4909|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4909
74063610|NCT00563524|147678730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.2200
74063611|NCT00563524|147678730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4183|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4183
74063612|NCT00563524|147678730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.465|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4650
74063613|NCT00563524|147678731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7051|||||||ANCOVA|||Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.7051
74063614|NCT00563524|147678731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1072|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.1072
74063615|NCT00563524|147678731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0020
74063616|NCT00563524|147678731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0079|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0079
74063617|NCT00563524|147678731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0308|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0308
74063618|NCT01222715|147678749|SUPERIORITY_OR_OTHER|||||||0.0124|TWO_SIDED|95.0|||||Log Rank|||The event free survival distributions of patients in Regimen A and Regimen B were compared using the log-rank test.||||0.0124
74063619|NCT02239601|147678777|OTHER||Odds Ratio (OR)|0.41||||0.053|TWO_SIDED|95.0|0.17|1.01|||Mixed Models Analysis|||||1.01|0.17|0.053
74063620|NCT04682639|147678796|OTHER||LS mean difference|-18.54||||0.0103|TWO_SIDED|95.0|-32.6|-4.49|||ANCOVA||Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.|||-4.49|-32.60|0.0103
74063621|NCT04682639|147678796|OTHER||LS mean difference|-7.53||||0.2861|TWO_SIDED|95.0|-21.48|6.42|||ANCOVA||Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.|||6.42|-21.48|0.2861
74063622|NCT04682639|147678797|OTHER||LS mean difference|2.38||||0.4894|TWO_SIDED|95.0|-4.43|9.19|||Linear mixed effects model|||||9.19|-4.43|0.4894
74063623|NCT04682639|147678797|OTHER||LS mean difference|4.7||||0.1671|TWO_SIDED|95.0|-2.0|11.41|||Linear mixed effects model|||||11.41|-2.00|0.1671
74063624|NCT04682639|147678798|OTHER||LS mean difference|-54.53||||0.0565|TWO_SIDED|95.0|-110.59|1.54|||ANCOVA|||||1.54|-110.59|0.0565
74063625|NCT04682639|147678798|OTHER||LS mean difference|-13.95||||0.6193|TWO_SIDED|95.0|-69.61|41.71|||ANCOVA|||||41.71|-69.61|0.6193
74063626|NCT04682639|147678799|OTHER||Adjusted difference from placebo|21.9||||0.0007|TWO_SIDED|95.0|9.23|34.57|||Mantel Haenszel|||||34.57|9.23|0.0007
74063627|NCT04682639|147678799|OTHER||Adjusted difference from placebo|13.85||||0.0121|TWO_SIDED|95.0|3.03|24.66|||Mantel Haenszel|||||24.66|3.03|0.0121
74063628|NCT04682639|147678800|OTHER||Adjusted difference from placebo|12.15||||0.0173|TWO_SIDED|95.0|2.15|22.16|||Mantel Haenszel|||||22.16|2.15|0.0173
74063629|NCT04682639|147678800|OTHER||Adjusted difference from placebo|8.37||||0.059|TWO_SIDED|95.0|-0.32|17.07|||Mantel Haenszel|||||17.07|-0.32|0.0590
74063630|NCT00450177|147678814|OTHER|||||||0.03|||||||Chi-squared|||||||0.03
73882748|NCT00528957|147299409|NON_INFERIORITY_OR_EQUIVALENCE|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \< 400 copies/mL was 92% for participants switching to tenofovir DF and 90% for participants continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48.|Difference in percentages between groups|-8.5|||||TWO_SIDED|95.0|-21.5|4.5|||Normal approximation|The difference between the two proportions and its CI were based on normal approximation methods.|Difference is for tenofovir DF minus stavudine or zidovudine (randomized phase)|"The statistical hypotheses for the primary endpoint was as follows:~* Null Hypothesis: tenofovir DF group is more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA concentrations \< 400 copies/mL at Week 48.~* Alternate Hypothesis: tenofovir DF group is no more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48."||4.5|-21.5|
73882749|NCT00528957|147299410|NON_INFERIORITY|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \< 400 copies/mL was 92% for subjects switching to tenofovir DF and 90% for subjects continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48.|Difference in percentages between groups|-0.9|||||TWO_SIDED|95.0|-13.7|11.8|||||The difference between the two proportions and its CI were based on normal approximation methods.|||11.8|-13.7|
73888288|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|81.3||||0.0011|TWO_SIDED|95.0|33.2|129.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||129.3|33.2|0.0011
74063631|NCT02613416|147678823|OTHER|||||||0.026||||||The p value was calculated.|Blyth-Still Casella Confidence Interval|||The primary hypothesis for this early phase study was that at least 30% of women would experience a \>5% relative decrease in their breast density after 6 months of treatment with denosumab 120 mg subcutaneous dose once a month.||||0.026
74063632|NCT00763269|147678826|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74063633|NCT00763269|147678827|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74063634|NCT00763269|147678828|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74063635|NCT00763269|147678829|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74063636|NCT02609178|147678831|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.003||||||Alpha value was set at 0.05.|ANOVA|||||||0.003
74063637|NCT02609178|147678831|NON_INFERIORITY_OR_EQUIVALENCE|stated above in statistical analysis 1||||||0.366||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.366
74063638|NCT02609178|147678831|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.002
74063639|NCT02609178|147678831|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.054||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.054
74063640|NCT02609178|147678832|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.006||||||alpha value was set at 0.05|Kruskal-Wallis|||||||0.006
74063641|NCT02609178|147678832|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistic analysis 1.||||||0.739||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.739
74063642|NCT02609178|147678832|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.03||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.03
74063643|NCT02609178|147678832|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.009||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.009
74063644|NCT02609178|147678833|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.001||||||alpha value was set at 0.05|Kruskal-Wallis|||||||0.001
74063645|NCT02609178|147678833|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.579||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.579
74063646|NCT02609178|147678833|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.001||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.001
74063647|NCT02609178|147678833|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.002
74063648|NCT02609178|147678834|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.007||||||alpha value was set at 0.05|ANOVA|||||||0.007
74063649|NCT02609178|147678834|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.308||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.308
74063650|NCT02609178|147678834|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.005||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.005
74063651|NCT02609178|147678834|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.141||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.141
74063652|NCT01128153|147678835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.099|<|0.0001|TWO_SIDED|95.0|-0.86|-0.47|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-0.47|-0.86|<0.0001
74063653|NCT01128153|147678836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|7.667||0.0301|TWO_SIDED|95.0|-31.85|-1.62|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-1.62|-31.85|0.0301
74063654|NCT01128153|147678837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.426||0.0301|TWO_SIDED|95.0|-1.77|-0.09|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-0.09|-1.77|0.0301
74063655|NCT01128153|147678838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|4.595||0.0868|TWO_SIDED|95.0|-16.96|1.15|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||1.15|-16.96|0.0868
74063656|NCT01128153|147678839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.255||0.0868|TWO_SIDED|95.0|-0.94|0.06|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||0.06|-0.94|0.0868
74063657|NCT01128153|147678840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.006|||<|0.0001|TWO_SIDED|95.0|3.852|21.05|||ANCOVA||Estimated Odds Ratio from the logistic regression model (Saxa/Placebo)|||21.05|3.852|<0.0001
74063658|NCT01682512|147678842|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence for the change in DAS28 (ESR) was evaluated based on the two-sided 90% Confidence Interval (CI) for the treatment difference with respect to the mean change in the DAS28(ESR) score compared to baseline. Null hypothesis of non-equivalence was to be rejected if the 90% CI is fully contained within the interval of \[-0.5, 0.5\].|Adjusted mean difference|-0.4|||||TWO_SIDED|90.0|-0.83|-0.03||Model analyzed was: DAS28(ESR) change from Baseline at Week 24 = overall mean + treatment + DAS28(ESR) Baseline score + visit + visit by treatment interaction + baseline-by-visit interaction + random error.|Mixed Models Analysis|A restricted maximum likelihood (REML)-based Mixed-Effect Model Repeated Measure (MMRM) approach was used.|Adjusted mean difference was calculated as: BI 695500 - Rituxan®|||-0.03|-0.83|
74063659|NCT01682512|147678843|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|102.35|STANDARD_ERROR_OF_MEAN|107.7|||TWO_SIDED|90.0|90.5|115.76|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and Rituxan.||115.76|90.50|
74063660|NCT01682512|147678843|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|88.21|STANDARD_ERROR_OF_MEAN|107.5|||TWO_SIDED|90.0|78.24|99.46|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and MabThera.||99.46|78.24|
74063661|NCT01682512|147678843|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|86.18|STANDARD_ERROR_OF_MEAN|107.449|||TWO_SIDED|90.0|76.5|97.09|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups Rituxan and MabThera.||97.09|76.50|
74063662|NCT01682512|147678844|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|102.46|STANDARD_ERROR_OF_MEAN|107.939|||TWO_SIDED|90.0|90.26|116.3|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and Rituxan.||116.30|90.26|
74063663|NCT01682512|147678844|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|86.0|STANDARD_ERROR_OF_MEAN|107.404|||TWO_SIDED|90.0|76.38|96.82|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and MabThera.||96.82|76.38|
74063664|NCT01682512|147678844|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|83.93|STANDARD_ERROR_OF_MEAN|107.386|||TWO_SIDED|90.0|74.57|94.47|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups Rituxan and MabThera.||94.47|74.57|
74063665|NCT01682512|147678845|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|95.87|STANDARD_ERROR_OF_MEAN|106.608|||TWO_SIDED|90.0|86.21|106.62|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and Rituxan.||106.62|86.21|
74063666|NCT01682512|147678845|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|89.46|STANDARD_ERROR_OF_MEAN|106.775|||TWO_SIDED|90.0|80.23|99.74|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and MabThera.||99.74|80.23|
74063667|NCT01682512|147678845|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|93.31|STANDARD_ERROR_OF_MEAN|105.7|||TWO_SIDED|90.0|85.11|102.29|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups Rituxan and MabThera.||102.29|85.11|
73888289|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|77.1||||0.0018|TWO_SIDED|95.0|29.1|125.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||125.2|29.1|0.0018
74063668|NCT01682512|147678846|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|93.97|STANDARD_ERROR_OF_MEAN|105.995|||TWO_SIDED|90.0|85.32|103.5|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and Rituxan.||103.50|85.32|
74063669|NCT01682512|147678846|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|89.3|STANDARD_ERROR_OF_MEAN|105.657|||TWO_SIDED|90.0|81.51|97.83|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and MabThera.||97.83|81.51|
74063670|NCT01682512|147678846|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|95.02|STANDARD_ERROR_OF_MEAN|105.744|||TWO_SIDED|90.0|86.62|104.25|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups Rituxan and MabThera.||104.25|86.62|
74063671|NCT01682512|147678848|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|104.49|STANDARD_ERROR_OF_MEAN|108.044|||TWO_SIDED|90.0|91.92|118.78|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and Rituxan.||118.78|91.92|
74063672|NCT01682512|147678848|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|91.39|STANDARD_ERROR_OF_MEAN|107.253|||TWO_SIDED|90.0|81.38|102.64|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and MabThera.||102.64|81.38|
74063673|NCT01682512|147678848|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|87.47|STANDARD_ERROR_OF_MEAN|107.896|||TWO_SIDED|90.0|77.12|99.21|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups Rituxan and MabThera.||99.21|77.12|
74063674|NCT03471182|147678973|SUPERIORITY|||||||0.035||||||Primary hypothesis of a group difference (i.e., CUD vs HHC-PET participants) in mGluR5 availability was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||Outcome Measure Data were tested using a single linear mixed effects model. The 9 regions of interest (i.e., all 9 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of region. Group (i.e., CUD, HHC-PET) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the region-by-group interaction term and a factor to model the random-effect of participant.||||0.035
74063675|NCT03471182|147678974|SUPERIORITY|Outcome Measure Data were tested using a single linear mixed effects model. The 4 brain networks of interest (i.e., all 4 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of network. Group (i.e., CUD, HC-MRI) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the network-by-group interaction term and a factor to model the random-effect of participant.||||||0.024||||||Primary hypothesis of group differences (i.e., CUD vs HC-MRI participants) in functional brain network engagement was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||||||0.024
74063676|NCT03471182|147678975|SUPERIORITY|||||||0.87||||||Primary hypothesis of group differences (i.e., CUD vs HC-MRI participants) in fALFF was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||Outcome Measure Data were tested using a single linear mixed effects model. The 5 brain networks of interest (i.e., all 5 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of network. Group (i.e., CUD, HC-MRI) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the network-by-group interaction term and a factor to model the random-effect of participant.||||0.870
74063677|NCT01875991|147678984|SUPERIORITY_OR_OTHER|||||||0.501|||||||Van Elteren test|P-value for 'All subjects' from Van Elteren test adjusting for strata (RA or PsO)||||||0.501
74063678|NCT00417027|147679020|SUPERIORITY_OR_OTHER||||||>|0.05||||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||>0.05
74063679|NCT00417027|147679020|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||0.005
74063680|NCT00417027|147679020|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||0.02
74063681|NCT00417027|147679021|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Kruskal-Wallis|||||||0.54
74063682|NCT00417027|147679022|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Kruskal-Wallis|||||||0.32
74063683|NCT00417027|147679023|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Kruskal-Wallis|||||||0.69
73888290|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|63.6||||0.0098|TWO_SIDED|95.0|15.6|111.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||111.7|15.6|0.0098
73882750|NCT02051764|147299464|OTHER|||||||0.2837||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Overall change from baseline between groups. Test compared slopes of cognitively impaired (CI) vs healthy volunteers (HV). As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were the different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.2837
74063684|NCT00417027|147679024|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||Analysis applies to all rows.|Chi-squared, Corrected|||Analysis apply to all rows. Only 1 comparison was made between the groups in distribution of number of bolus doses.||||0.72
74063685|NCT00417027|147679025|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Kruskal-Wallis|||||||0.41
74063686|NCT00417027|147679026|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Kruskal-Wallis|||||||0.85
74063687|NCT04991311|147679028|SUPERIORITY||Mean Difference (Final Values)|398.4|STANDARD_DEVIATION|581.6|=|0.0585|TWO_SIDED|95.0|-17.6|814.4|||Paired t-test (2-sided, alpha=0.05)|||The participants in both comparison groups are the same.||814.4|-17.6|= 0.0585
74063688|NCT00054275|147679055|SUPERIORITY_OR_OTHER||proportion of pts with partial response|0.39||||0.95|TWO_SIDED|95.0|0.23|0.58|||confidence interval for partial response|Confidence interval for partial response rate using Wilson's Method||||0.58|0.23|0.95
74063689|NCT01676311|147679058|SUPERIORITY|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group, CVLT-II-total learning score at baseline and week 12, and covariates (Beck Depression Index \[BDI\], time post-injury, British Columbia Postconcussion Symptom Inventory \[BC-PSI\]). Regression analyses were repeated, permuting data observations for each outcome. The BDI and BC-PSI are covariates in the regression model and not pre-specified Primary and Secondary Outcome Measures.||||0.38
74063690|NCT01676311|147679058|SUPERIORITY|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-short delay free recall (SDFR) score, outcome (CVLT-II-SDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.||||0.38
74063691|NCT01676311|147679058|SUPERIORITY|||||||0.42||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-long delay free recall (LDFR) score, outcome (CVLT-II-LDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.||||0.42
74063692|NCT01676311|147679061|SUPERIORITY|||||||0.48||||||A chi-square test with factors of group (Huperzine A, placebo) and occurrence of seizure (yes, no) was performed. A permutation test was the used to assess the effect of Huperzine A on the prevalence of seizures.|Chi-squared test and permutation test|||||||0.48
74063693|NCT01676311|147679062|SUPERIORITY|||||||0.44||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of behavioral side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of behavioral side effects.|Chi-squared test and permutation test|||Behavioral side effects statistical analysis||||0.44
74063694|NCT01676311|147679062|SUPERIORITY|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of cardiac-respiratory side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Cardiac-respiratory side effects statistical analysis||||0.81
74063695|NCT01676311|147679062|SUPERIORITY|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of dermatological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of dermatological side effects.|Chi-squared test and permutation test|||Dermatological side effects statistical analysis||||0.81
74063696|NCT01676311|147679062|SUPERIORITY|||||||0.73||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of gastrointestinal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Gastrointestinal side effects statistical analysis||||0.73
74063697|NCT01676311|147679062|SUPERIORITY|||||||0.54||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of genitourinary/neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects|Chi-squared test and permutation test|||Genitourinary/neurological side effects statistical analysis||||0.54
74063698|NCT01676311|147679062|SUPERIORITY|||||||0.27||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of hematological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Hematological side effects statistical analysis||||0.27
74063699|NCT01676311|147679062|SUPERIORITY|||||||0.41||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of musculoskeletal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Musculoskeletal side effects statistical analysis||||0.41
74063700|NCT01676311|147679062|SUPERIORITY|||||||1||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Neurological side effects statistical analysis||||1.00
74063701|NCT01347879|147679073|SUPERIORITY_OR_OTHER||Difference in least square means|-7.35||||0.006|TWO_SIDED|95.0|-12.5|-2.2|||ANCOVA|Lesion count at baseline and center as covariates||||-2.2|-12.5|0.006
73882751|NCT02051764|147299464|OTHER|||||||0.9276||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Change from baseline between groups for amyloid negative only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.9276
73882752|NCT02051764|147299464|OTHER|||||||0.6324||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Change from baseline between groups for amyloid positive only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.6324
73882753|NCT00988832|147299493|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
74063702|NCT01347879|147679074|SUPERIORITY_OR_OTHER||Difference in least square means|-0.6||||0.8527|TWO_SIDED|95.0|-6.6|5.5|||ANCOVA|Lesion count at baseline and center as covariates||||5.5|-6.6|0.8527
74063703|NCT01347879|147679075|SUPERIORITY_OR_OTHER||Difference in least square means|-20.0||||0.0032|TWO_SIDED|95.0|-33.2|-6.8|||ANCOVA|Lesion count at baseline and center as covariates||||-6.8|-33.2|0.0032
74063704|NCT01347879|147679076|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||Regression, Logistic|||||||0.0125
74063705|NCT01347879|147679081|SUPERIORITY_OR_OTHER||Difference in least square means|-2.56||||0.7161|TWO_SIDED|95.0|-16.5|11.3|||ANCOVA|Lesion count at baseline and center as covariate||||11.3|-16.5|0.7161
74063706|NCT00323271|147679087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108||||0.911|TWO_SIDED|95.0|-2.106|1.888|||t-test, 2 sided|||||1.888|-2.106|.911
74063707|NCT00323271|147679088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.644||||0.32|TWO_SIDED|95.0|-1.058|2.345||Multiple imputation used to account for missing variables; pre-treatment rating and years of MS pain were covariates|ANCOVA|||||2.345|-1.058|0.320
74063708|NCT00068770|147679089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|1.0||0.82|TWO_SIDED|95.0|1.5|5.5||not adjusted|t-test, 2 sided|||two independent group comparisons||5.5|1.5|0.82
74063709|NCT00068770|147679090|NON_INFERIORITY_OR_EQUIVALENCE|equivalence analysis|Hazard Ratio (HR)|2.7|STANDARD_DEVIATION|1.8||0.11|TWO_SIDED|95.0|1.1|6.3|||Log Rank|||||6.3|1.1|0.11
74063710|NCT02572427|147679092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED||||||t-test, 2 sided|||||||0.039
74063711|NCT02572427|147679093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
74063712|NCT00996918|147679104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.39|TWO_SIDED|95.0|-4.29|1.68|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a restricted maximum likelihood (REML)-based mixed model for repeated measures (MMRM) with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.68|-4.29|0.390
74063713|NCT00996918|147679104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.264|TWO_SIDED|95.0|-1.37|4.97|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.97|-1.37|0.264
74063714|NCT00996918|147679104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.357|TWO_SIDED|95.0|-4.74|1.72|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.72|-4.74|0.357
74063715|NCT00996918|147679104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.981|TWO_SIDED|95.0|-3.5|3.42|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.42|-3.50|0.981
74063716|NCT00996918|147679104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.584|TWO_SIDED|95.0|-4.37|2.47|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.47|-4.37|0.584
74063717|NCT00996918|147679104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58||||0.392|TWO_SIDED|95.0|-2.05|5.2|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.20|-2.05|0.392
73882754|NCT00988832|147299494|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANOVA|||||||0.0004
73882755|NCT00988832|147299495|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||ANOVA|||||||0.0041
73882756|NCT00988832|147299496|SUPERIORITY_OR_OTHER|||||||0.0423||95.0|||||ANOVA|||||||0.0423
74063718|NCT00996918|147679104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.345|TWO_SIDED|95.0|-6.34|2.24|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.24|-6.34|0.345
74063719|NCT00996918|147679104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.922|TWO_SIDED|95.0|-4.73|4.28|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.28|-4.73|0.922
74063720|NCT00996918|147679104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44||||0.384|TWO_SIDED|95.0|-7.97|3.1|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.10|-7.97|0.384
74063721|NCT00996918|147679104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.961|TWO_SIDED|95.0|-6.08|5.78|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.78|-6.08|0.961
74063722|NCT00996918|147679105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.837|TWO_SIDED|95.0|-1.91|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.35|-1.91|0.837
74063723|NCT00996918|147679105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||0.064|TWO_SIDED|95.0|-0.13|4.41|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.41|-0.13|0.064
74063724|NCT00996918|147679105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.99|TWO_SIDED|95.0|-2.32|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.35|-2.32|0.990
74063725|NCT00996918|147679105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.817|TWO_SIDED|95.0|-2.22|2.82|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.82|-2.22|0.817
74063726|NCT00996918|147679105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.697|TWO_SIDED|95.0|-2.04|3.05|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.05|-2.04|0.697
74063727|NCT00996918|147679105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.158|TWO_SIDED|95.0|-0.76|4.63|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.63|-0.76|0.158
74063728|NCT00996918|147679105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.829|TWO_SIDED|95.0|-4.06|3.26|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.26|-4.06|0.829
73882757|NCT00988832|147299497|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANOVA|||||||0.0006
73882758|NCT00988832|147299498|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||ANOVA|||||||0.0014
73882759|NCT00988832|147299500|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
73882760|NCT04267380|147299501|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
73882761|NCT04267380|147299502|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
73882762|NCT04267380|147299503|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
73882763|NCT04267380|147299504|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
73882764|NCT04267380|147299505|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
74063729|NCT00996918|147679105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.95|TWO_SIDED|95.0|-3.69|3.93|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.93|-3.69|0.950
74063730|NCT00996918|147679105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.816|TWO_SIDED|95.0|-5.35|4.23|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.23|-5.35|0.816
74063731|NCT00996918|147679105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.751|TWO_SIDED|95.0|-4.32|5.96|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.96|-4.32|0.751
74063732|NCT00996918|147679106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.967|TWO_SIDED|95.0|-7.22|7.53|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.53|-7.22|0.967
74063733|NCT00996918|147679106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13||||0.593|TWO_SIDED|95.0|-5.72|9.98|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.98|-5.72|0.593
74063734|NCT00996918|147679106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.968|TWO_SIDED|95.0|-7.32|7.62|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.62|-7.32|0.968
74063735|NCT00996918|147679106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92||||0.473|TWO_SIDED|95.0|-10.92|5.08|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.08|-10.92|0.473
74063736|NCT00996918|147679106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95||||0.63|TWO_SIDED|95.0|-9.91|6.02|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.02|-9.91|0.630
74063737|NCT00996918|147679106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53||||0.293|TWO_SIDED|95.0|-13.02|3.95|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.95|-13.02|0.293
74063738|NCT00996918|147679106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.733|TWO_SIDED|95.0|-7.28|10.33|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||10.33|-7.28|0.733
74063739|NCT00996918|147679106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81||||0.55|TWO_SIDED|95.0|-12.06|6.45|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.45|-12.06|0.550
74063740|NCT00996918|147679106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.902|TWO_SIDED|95.0|-11.04|12.5|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||12.50|-11.04|0.902
74063741|NCT00996918|147679106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07||||0.43|TWO_SIDED|95.0|-17.75|7.61|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.61|-17.75|0.430
73882765|NCT04267380|147299506|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
73882766|NCT04267380|147299507|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
73882767|NCT04267380|147299508|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
74063742|NCT00996918|147679107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.683|TWO_SIDED|95.0|-6.01|3.95|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.95|-6.01|0.683
74063743|NCT00996918|147679107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.177|TWO_SIDED|95.0|-1.68|9.06|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.06|-1.68|0.177
74063744|NCT00996918|147679107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.734|TWO_SIDED|95.0|-6.03|4.25|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.25|-6.03|0.734
74063745|NCT00996918|147679107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.595|TWO_SIDED|95.0|-7.06|4.05|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.05|-7.06|0.595
74063746|NCT00996918|147679107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.409|TWO_SIDED|95.0|-7.95|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.24|-7.95|0.409
74063747|NCT00996918|147679107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.368|TWO_SIDED|95.0|-8.73|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.24|-8.73|0.368
74063748|NCT00996918|147679107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.458|TWO_SIDED|95.0|-4.01|8.89|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||8.89|-4.01|0.458
74063749|NCT00996918|147679107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.76|TWO_SIDED|95.0|-7.77|5.68|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.68|-7.77|0.760
74063750|NCT00996918|147679107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.597|TWO_SIDED|95.0|-5.67|9.86|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.86|-5.67|0.597
74063751|NCT00996918|147679107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87||||0.501|TWO_SIDED|95.0|-11.24|5.5|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.50|-11.24|0.501
74063752|NCT00996918|147679108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.183|TWO_SIDED|95.0|-8.91|1.71|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.71|-8.91|0.183
74063753|NCT00996918|147679108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.92|TWO_SIDED|95.0|-5.92|5.35|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.35|-5.92|0.920
74063754|NCT00996918|147679108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.99||||0.133|TWO_SIDED|95.0|-11.52|1.53|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.53|-11.52|0.133
73882768|NCT04267380|147299510|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
74063755|NCT00996918|147679108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.505|TWO_SIDED|95.0|-4.55|9.22|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.22|-4.55|0.505
74063756|NCT00996918|147679108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.86||||0.003|TWO_SIDED|95.0|-21.46|-4.25|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||-4.25|-21.46|0.003
74063757|NCT00996918|147679108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||0.76|TWO_SIDED|95.0|-7.95|10.88|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||10.88|-7.95|0.760
74063758|NCT00996918|147679109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08||||0.373|TWO_SIDED|95.0|-6.68|2.52|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.52|-6.68|0.373
74063759|NCT00996918|147679109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.677|TWO_SIDED|95.0|-5.92|3.86|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.86|-5.92|0.677
74063760|NCT00996918|147679109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.28|TWO_SIDED|95.0|-9.61|2.8|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.80|-9.61|0.280
74063761|NCT00996918|147679109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.95|TWO_SIDED|95.0|-6.34|6.76|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.76|-6.34|0.950
74063762|NCT00996918|147679109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.06||||0.13|TWO_SIDED|95.0|-23.16|3.05|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.05|-23.16|0.130
74063763|NCT00996918|147679109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48||||0.732|TWO_SIDED|95.0|-11.97|16.94|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||16.94|-11.97|0.732
74063764|NCT00996918|147679110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.938|TWO_SIDED|95.0|-1.12|1.21|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.21|-1.12|0.938
74063765|NCT00996918|147679110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.753|TWO_SIDED|95.0|-1.43|1.04|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.04|-1.43|0.753
73882769|NCT04267380|147299511|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
74063766|NCT00996918|147679110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.809|TWO_SIDED|95.0|-1.04|1.33|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.33|-1.04|0.809
74063767|NCT00996918|147679110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.421|TWO_SIDED|95.0|-1.8|0.75|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.75|-1.80|0.421
74063768|NCT00996918|147679110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.535|TWO_SIDED|95.0|-0.85|1.63|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.63|-0.85|0.535
74063769|NCT00996918|147679110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.445|TWO_SIDED|95.0|-0.82|1.86|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.86|-0.82|0.445
74063770|NCT00996918|147679110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.309|TWO_SIDED|95.0|-0.67|2.12|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.12|-0.67|0.309
74063771|NCT00996918|147679110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.872|TWO_SIDED|95.0|-1.34|1.57|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.57|-1.34|0.872
73882770|NCT04267380|147299512|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
73882771|NCT04267380|147299513|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||||||0.83
74063772|NCT00996918|147679110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.004|TWO_SIDED|95.0|0.79|4.26|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.26|0.79|0.004
74063773|NCT00996918|147679110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.026|TWO_SIDED|95.0|0.25|3.93|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.93|0.25|0.026
74063774|NCT00996918|147679111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.504|TWO_SIDED|95.0|-0.77|1.57|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.57|-0.77|0.504
74063775|NCT00996918|147679111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.592|TWO_SIDED|95.0|-1.58|0.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.90|-1.58|0.592
74063776|NCT00996918|147679111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.441|TWO_SIDED|95.0|-0.72|1.65|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.65|-0.72|0.441
74063777|NCT00996918|147679111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.288|TWO_SIDED|95.0|-1.97|0.59|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.59|-1.97|0.288
74063778|NCT00996918|147679111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.303|TWO_SIDED|95.0|-0.59|1.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.90|-0.59|0.303
74063779|NCT00996918|147679111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.713|TWO_SIDED|95.0|-1.09|1.6|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.60|-1.09|0.713
73882772|NCT04267380|147299514|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
73882773|NCT04267380|147299515|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
74063780|NCT00996918|147679111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.198|TWO_SIDED|95.0|-0.49|2.34|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.34|-0.49|0.198
73882774|NCT04267380|147299516|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
73882775|NCT04267380|147299517|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||||||0.99
73882776|NCT04267380|147299518|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
73882777|NCT04267380|147299519|SUPERIORITY|||||||0.63|||||||Chi-squared|||||||0.63
73882778|NCT04267380|147299520|SUPERIORITY|||||||0.25|||||||Chi-squared|||||||0.25
73882779|NCT03155724|147299548|SUPERIORITY||||||<|0.0001|||||||Exact, binomial, one-sided|||The primary endpoint 1 hypothesis was evaluated by performing an exact, binomial test comparing the binomial proportion of 'improved' patients to 3.0% with power of 80% and type 1 error (alpha) of 0.0224. A pre-planned interim analysis at 45 patients required a type 1 error (alpha) of 0.0026 to demonstrate significance.||||<0.0001
73882780|NCT04231669|147299609|SUPERIORITY|||||||0.05|||||||Linear Mixed-effects regression|||||||0.05
73882781|NCT05543265|147299640|SUPERIORITY||Mean Difference (Final Values)|22.0|||<|0.001|TWO_SIDED|95.0|6.4|28.8|||Chi-squared|||||28.8|6.4|<0.001
74063781|NCT00996918|147679111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.756|TWO_SIDED|95.0|-1.7|1.24|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.24|-1.70|0.756
74063782|NCT00996918|147679111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45||||0.006|TWO_SIDED|95.0|0.69|4.22|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.22|0.69|0.006
74063783|NCT00996918|147679111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.75||||0.066|TWO_SIDED|95.0|-0.12|3.62|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.62|-0.12|0.066
74063784|NCT01029769|147679117|OTHER|"a logistic regression model with remission as the dependent variable and switch of treatment (yes/no) and PANSS-total score at visit 3 as independent variables was used. Multiple imputation (based upon 20 imputations, primary analysis), last observation carried forward and completers only analyses were performed."|||||=|0.01||||||Multiple imputation was performed separately for the switch and non-switch arms and the imputation model included the PANSS total score from all visits from phase II baseline (visit 2) onwards, remission at visit 7 and phase I arm allocation|Regression, Logistic|||Irrespective of the initially assigned antipsychotic treatment in period 1 of the trial (2-week-phase), the patients showing little improvement over the two weeks of treatment in period 1 now switched from the initial treatment in period 2 of the trial (6-week-phase) were grouped together as well as the patients non-switched from their initial treatment.||||=0.01
74063785|NCT00854607|147679136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.166|TWO_SIDED|90.0|-0.2|0.77||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.77|-0.20|0.166
74063786|NCT00854607|147679137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.269|TWO_SIDED|90.0|-0.65|0.3||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.30|-0.65|0.269
74063787|NCT00854607|147679138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.101|TWO_SIDED|90.0|-0.06|0.44||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.44|-0.06|0.101
74063788|NCT00854607|147679139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.457|TWO_SIDED|90.0|-0.42|0.47||One-Sided P-Value|t-test, 1 sided|||Mean Difference Between Non-Responders and Responders||0.47|-0.42|0.457
74063789|NCT00854607|147679140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.168|TWO_SIDED|90.0|-0.87|0.23||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.23|-0.87|0.168
73882782|NCT05316597|147299668|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.914|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.914
74063790|NCT00854607|147679141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.127|TWO_SIDED|90.0|-0.09|0.46||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.46|-0.09|0.127
74063791|NCT00854607|147679142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.054|TWO_SIDED|90.0|-0.01|0.96||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.96|-0.01|0.054
74063792|NCT00854607|147679143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.285|TWO_SIDED|90.0|-0.41|0.83||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.83|-0.41|0.285
74063793|NCT00854607|147679144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.159|TWO_SIDED|90.0|-0.27|1.08||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||1.08|-0.27|0.159
74063794|NCT00854607|147679145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.071|TWO_SIDED|90.0|-0.02|0.32||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.32|-0.02|0.071
74063795|NCT00854607|147679146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.078|TWO_SIDED|90.0|-0.03|0.38||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.38|-0.03|0.078
74063796|NCT00854607|147679147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.109|TWO_SIDED|90.0|-0.13|0.91||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.91|-0.13|0.109
74063797|NCT00854607|147679148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.03|TWO_SIDED|90.0|0.09|1.22||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||1.22|0.09|0.030
74063798|NCT00854607|147679149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.293|TWO_SIDED|90.0|-0.63|0.32||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.32|-0.63|0.293
74063799|NCT00854607|147679150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.213|TWO_SIDED|90.0|-0.83|0.29||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.29|-0.83|0.213
74063800|NCT02567266|147679158|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.338|TWO_SIDED|95.0|-0.58|0.2||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post-Treatment||.20|-.58|.338
74063801|NCT02567266|147679158|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.2||0.425|TWO_SIDED|95.0|-0.24|0.57||Threshold: p \<.05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post Treatment||0.57|-0.24|0.425
74063802|NCT02567266|147679158|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.09|TWO_SIDED|95.0|-0.77|0.06||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post||0.06|-0.77|0.09
74063803|NCT02567266|147679158|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.2||0.126|TWO_SIDED|95.0|-0.72|0.09||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.09|-0.72|0.126
74063804|NCT02567266|147679158|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.28|TWO_SIDED|95.0|-0.65|0.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.19|-0.65|0.28
74063805|NCT02567266|147679158|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.21||0.697|TWO_SIDED|95.0|-0.51|0.34||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.34|-0.51|0.697
74063806|NCT02567266|147679159|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.779|TWO_SIDED|95.0|-0.6|0.45||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.45|-0.6|0.779
74063807|NCT02567266|147679159|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.27||0.66|TWO_SIDED|95.0|-0.42|0.67||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.67|-0.42|0.66
74063808|NCT02567266|147679159|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.629|TWO_SIDED|95.0|-0.51|0.31||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.31|-0.51|0.629
74063809|NCT02567266|147679159|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.938|TWO_SIDED|95.0|-0.41|0.38||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.38|-0.41|0.938
74063810|NCT02567266|147679159|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.21||0.68|TWO_SIDED|95.0|-0.32|0.49||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.49|-0.32|0.68
74063811|NCT02567266|147679159|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.479|TWO_SIDED|95.0|-0.75|0.35||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.35|-0.75|0.479
74063812|NCT02567266|147679160|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.58||0.852|TWO_SIDED|95.0|-2.85|3.45||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.45|-2.85|0.852
74063813|NCT02567266|147679160|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|1.62||0.917|TWO_SIDED|95.0|-3.41|3.07||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.07|-3.41|0.917
74063814|NCT02567266|147679160|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|1.66||0.778|TWO_SIDED|95.0|-2.81|3.74||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.74|-2.81|0.778
74063815|NCT02567266|147679160|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|2.12||0.66|TWO_SIDED|95.0|-3.3|5.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||5.19|-3.3|0.66
74063816|NCT02567266|147679160|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|2.19||0.935|TWO_SIDED|95.0|-4.55|4.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||4.19|-4.55|0.935
74063817|NCT02567266|147679160|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|2.21||0.615|TWO_SIDED|95.0|-3.29|5.55||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||5.55|-3.29|0.615
74063818|NCT00123487|147679161|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was claimed if the lower bound of the 95% CI for difference (QD - BD) was ≥ -12%.|Percent Difference|0.2|||||TWO_SIDED|95.0|-7.8|8.1||||||Primary endpoint was to be assessed at 6-Months: Assuming a 45% MaHR rate in the 70 mg BID participants, the primary efficacy analysis required a total of 540 participants, approximately 270 in each dosing schedule, giving at least 80% power to deduce non-inferiority of the QD schedule relative to the BID schedule if the lower bound of the 95% CI for the difference in MaHR rates (MaHRRQD - MaHRRBID) is greater than -12%.||8.1|-7.8|
74063819|NCT01039584|147679194|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy measure was the proportion of subjects with therapeutic cure at Visit 3/Test-of-Cure. Therapeutic cure was defined as having both a mycological cure and a clinical cure.|Yates continuity correction|1.5|||||TWO_SIDED|90.0|-9.1|12.3|||Wald's method|||||12.3|-9.1|
74063820|NCT01039584|147679195|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The efficacy measure was the proportion of subjects with clinicl cure at Visit 3/Test-of-Cure.|Yates continuity correction|1.5|||||TWO_SIDED|90.0|-7.3|12.8|||Wald's method|||||12.8|-7.3|
74063821|NCT01039584|147679196|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The efficacy measure was the proportion of subjects with mycological cure at Visit 3/Test-of-Cure|Yates continuity correction|1.5||||0.05|TWO_SIDED|90.0|-11.7|9.4|||Wald's method|||||9.4|-11.7|0.05
74063822|NCT03672396|147679199|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.13||||0.378|TWO_SIDED|95.0|-0.2|0.4|||t-test, 2 sided|||||0.4|-0.2|0.378
74063823|NCT03672396|147679200|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.35||||0.586|TWO_SIDED|95.0|-1.0|1.7|||t-test, 2 sided|||||1.7|-1.0|0.586
74063824|NCT03672396|147679201|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.25||||0.252|TWO_SIDED|95.0|-0.7|0.2|||t-test, 2 sided|||||0.2|-0.7|0.252
74063825|NCT03672396|147679202|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-16.3||||0.111|TWO_SIDED|95.0|-36.9|4.3|||t-test, 2 sided|Mean difference calculated as Post - Pre.||||4.3|-36.9|0.111
74063826|NCT03672396|147679203|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.4||||0.579|TWO_SIDED|95.0|-4.3|7.2|||t-test, 2 sided|||||7.2|-4.3|0.579
74063827|NCT03672396|147679204|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.1||||0.948|TWO_SIDED|95.0|-3.9|3.7|||t-test, 2 sided|||||3.7|-3.9|0.948
73882783|NCT05316597|147299669|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.554|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||.554
73882784|NCT05316597|147299670|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.905|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|||||||0.905
74063828|NCT03672396|147679205|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.2||||0.594|TWO_SIDED|95.0|-1.1|0.7|||t-test, 2 sided|||||0.7|-1.1|0.594
74063829|NCT03672396|147679206|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.8||||0.274|TWO_SIDED|95.0|-2.3|0.7|||t-test, 2 sided|||||0.7|-2.3|0.274
74063830|NCT03672396|147679207|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.89||||0.013|TWO_SIDED|95.0|0.48|3.29|||t-test, 2 sided|||||3.29|0.48|0.013
74063831|NCT03672396|147679208|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|4.16||||0.369|TWO_SIDED|95.0|-5.54|13.85|||t-test, 2 sided|||||13.85|-5.54|0.369
74063832|NCT03672396|147679209|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.4||||0.945|TWO_SIDED|95.0|-13.5|12.7|||t-test, 2 sided|||||12.7|-13.5|0.945
74063833|NCT03672396|147679210|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.3||||0.42|TWO_SIDED|95.0|-2.0|4.6|||t-test, 2 sided|||||4.6|-2.0|0.420
74063834|NCT03672396|147679211|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.6||||0.941|TWO_SIDED|95.0|-16.9|15.8|||t-test, 2 sided|||||15.8|-16.9|0.941
74063835|NCT03672396|147679212|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|2.3||||0.203|TWO_SIDED|95.0|-1.4|5.9|||t-test, 2 sided|||||5.9|-1.4|0.203
74063836|NCT03672396|147679213|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.3||||0.057|TWO_SIDED|95.0|-0.04|2.6|||t-test, 2 sided|||||2.6|-0.04|0.057
74063837|NCT03672396|147679214|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.1||||0.809|TWO_SIDED|95.0|-1.0|1.3|||t-test, 2 sided|||||1.3|-1.0|0.809
74063838|NCT03672396|147679215|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.4||||0.191|TWO_SIDED|95.0|-0.3|1.1|||t-test, 2 sided|||||1.1|-0.3|0.191
73882785|NCT05316597|147299671|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.076|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.076
73882786|NCT05316597|147299671|SUPERIORITY|||||||0.02||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||Exploratory ANOVA results comparing full and reduced models to test the effect of terpene exposure on pattern of outcome over time.||||0.02
73882787|NCT05316597|147299672|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.21|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.210
74063839|NCT03672396|147679216|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.5||||0.237|TWO_SIDED|95.0|-0.3|1.3|||t-test, 2 sided|||||1.3|-0.3|0.237
74063840|NCT00446134|147679310|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Other|12.75|STANDARD_DEVIATION|5.0||0.167|TWO_SIDED|95.0|-3.65|29.15|||Fisher Exact|||||29.15|-3.65|0.167
74063841|NCT00446134|147679310|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|5.71|STANDARD_DEVIATION|5.0||0.611|TWO_SIDED|95.0|-10.76|22.19|||Fisher Exact|||||22.19|-10.76|0.611
74063842|NCT00446134|147679310|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.98|STANDARD_DEVIATION|5.0||0.736|TWO_SIDED|95.0|-13.67|19.63|||Fisher Exact|||||19.63|-13.67|0.736
74063843|NCT00446134|147679310|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|7.04|STANDARD_DEVIATION|5.0||0.485|TWO_SIDED|95.0|-9.28|23.35|||Fisher Exact|||||23.35|-9.28|0.485
74063844|NCT00446134|147679310|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|9.77|STANDARD_DEVIATION|5.0||0.295|TWO_SIDED|95.0|-6.72|26.26|||Fisher Exact|||||26.26|-6.72|0.295
74063845|NCT00446134|147679310|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.73|STANDARD_DEVIATION|5.0||0.864|TWO_SIDED|95.0|-13.84|19.3|||Fisher Exact|||||19.3|-13.84|0.864
74063846|NCT00446134|147679311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4|STANDARD_DEVIATION|5.0||0.0304|TWO_SIDED|95.0|2.31|30.57|||Chi-squared|||||30.57|2.31|0.0304
74063847|NCT00446134|147679311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.1|STANDARD_DEVIATION|5.0||0.0293|TWO_SIDED|95.0|3.22|31.06|||Chi-squared|||||31.06|3.22|0.0293
74063848|NCT00446134|147679311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_DEVIATION|5.0||0.5816|TWO_SIDED|95.0|-10.41|20.24|||Chi-squared|||||20.24|-10.41|0.5816
74063849|NCT00446134|147679312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-13.78|16.22|||Fisher Exact|||||16.22|-13.78|0.9999
74063850|NCT00446134|147679312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.73|14.73|||Fisher Exact|||||14.73|-14.73|0.9999
74063851|NCT00446134|147679312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.11|15.71|||Fisher Exact|||||15.71|-14.11|0.9999
74063852|NCT00446134|147679312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-13.78|16.22|||Fisher Exact|||||16.22|-13.78|0.9999
74063853|NCT00446134|147679312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.76|15.59|||Fisher Exact|||||15.59|-14.76|0.9999
74063854|NCT00446134|147679312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-15.71|14.11|||Fisher Exact|||||14.11|-15.71|0.9999
74063855|NCT04583592|147679366|SUPERIORITY|||||||0.787||||||\<0.05|Chi-squared|||||||0.787
74063856|NCT03033069|147679388|SUPERIORITY||Least Squares (LS ) Mean Difference|-5.99|||=|0.0021|TWO_SIDED|95.0|-9.79|-2.19|||Mixed Model Repeated Measures (MMRM)|||MMRM analysis with an unstructured (UN) variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-2.19|-9.79|=0.0021
74063857|NCT03033069|147679388|SUPERIORITY||LS Mean Difference|-1.74|||=|0.3868|TWO_SIDED|95.0|-5.7|2.22|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||2.22|-5.70|=0.3868
73882788|NCT05316597|147299672|SUPERIORITY|||||||0.57||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||Exploratory ANOVA results comparing full and reduced models to test the effect of terpene exposure on pattern of outcome over time.||||0.57
74063858|NCT03033069|147679388|SUPERIORITY||LS Mean Difference|-0.91|||=|0.6399|TWO_SIDED|95.0|-4.74|2.92|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||2.92|-4.74|=0.6399
74063859|NCT03033069|147679388|SUPERIORITY||LS Mean Difference|-5.08|||=|0.0106|TWO_SIDED|95.0|-8.96|-1.2|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-1.20|-8.96|=0.0106
74063860|NCT03033069|147679388|SUPERIORITY||LS Mean Difference|-4.24|||=|0.0384|TWO_SIDED|95.0|-8.26|-0.23|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-0.23|-8.26|=0.0384
74063861|NCT02623426|147679391|SUPERIORITY||Ratio of the proportion of baseline|1.36|||<|0.001|TWO_SIDED|95.0|1.19|1.56||A Bonferroni correction was used to adjust for the co-primary hypotheses;a two-sided type I error rate of 0.05/2 = 0.025 was used to determine statistical significance for the two pairwise comparisons (Ozurdex vs Methotrexate and Ozurdex vs Lucentis)|mixed effects model||The treatment effect is the ratio of the proportions of baseline retinal thickness (Methotrexate/Ozurdex). Values greater than 1 indicate less reduction in retinal thickness in the Methotrexate treated group compared to Ozurdex|A sample size of 240 was calculated to provide 91% power to detect a 25% reduction for Ozurdex, a 38% reduction for Methotrexate and Lucentis assuming a standard deviation of 0.33, 25% with bilateral disease, between-eye correlation of 0.4, 10% loss to follow-up, and a two-sided type 1 error rate of 0.025 for each pairwise comparison.||1.56|1.19|<0.001
74063862|NCT02623426|147679391|SUPERIORITY||Ratio of the proportion of BL|1.22||||0.012|TWO_SIDED|95.0|1.04|1.43||A Bonferroni correction was used to adjust for the co-primary hypotheses;a two-sided type I error rate of 0.05/2 = 0.025 was used to determine statistical significance for the two pairwise comparisons (Ozurdex vs Methotrexate and Ozurdex vs Lucentis)|mixed effects model||The treatment effect is the ratio of the proportions of baseline retinal thickness (Lucentis/Ozurdex) at 12 weeks. Values greater than 1 indicate less reduction in retinal thickness in the Lucentis treated group compared to Ozurdex|A sample size of 240 was calculated to provide 91% power to detect a 25% reduction for Ozurdex, a 38% reduction for methotrexate and Lucentis assuming a standard deviation of 0.33, 25% with bilateral disease, between-eye correlation of 0.4, 10% loss to follow-up, and a two-sided type 1 error rate of 0.025 for each pairwise comparison.||1.43|1.04|0.012
74063863|NCT00500656|147679392|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.475|||<|0.001|TWO_SIDED|95.0|1.901|6.355|||The Wilcoxon version of the log rank|The median time to onset was calculated using Kaplan Meier methodology. The Wilcoxon version of the log rank test of SAS was used||||6.355|1.901|< 0.001
74063864|NCT00500656|147679393|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||The Wilcoxon version of the log rank|The median time to almost complete symptom relief was calculated using Kaplan Meier methodology.The Wilcoxon version of the log rank test SAS was used||||||< 0.001
74063865|NCT01142466|147679416|SUPERIORITY_OR_OTHER|||||||0.1384|||||||Log Rank|||Two-sided log rank test with alpha equal to 0.05 was used as the appropriate nonparametric method to compare the two groups.||||0.1384
74063866|NCT01142466|147679417|SUPERIORITY_OR_OTHER|||||||0.2635||95.0|||||Fisher Exact|||||||0.2635
74063867|NCT00681824|147679439|SUPERIORITY_OR_OTHER|||||||0.7159||95.0|||||likelihood ratio of chi squared test|||||||0.7159
74063868|NCT02229487|147679490|OTHER|||||||0.209|||||||Wilcoxon (Mann-Whitney)|||||||0.209
74063869|NCT01954082|147679494|SUPERIORITY||Risk Ratio (RR)|1.41||||0.0095|TWO_SIDED|95.0|1.08|1.83||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of mortality and/or severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the development of severe ROP and mortality.||1.83|1.08|0.0095
74063870|NCT01954082|147679495|SUPERIORITY||Risk Ratio (RR)|1.03||||0.6599|TWO_SIDED|95.0|0.91|1.16||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of BPD is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of BPD.||1.16|0.91|0.6599
74063871|NCT01954082|147679496|SUPERIORITY||Risk Ratio (RR)|1.05||||0.3883|TWO_SIDED|95.0|0.94|1.17||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of BPD or on mortality due to BDP.||1.17|0.94|0.3883
73882789|NCT05316597|147299673|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.921|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.921
74063872|NCT01954082|147679497|SUPERIORITY||Risk Ratio (RR)|1.53||||0.0306|TWO_SIDED|95.0|1.03|2.25||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of mortality prior to ROP endpoint is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on survival to ROP endpoint.||2.25|1.03|0.0306
74063873|NCT01954082|147679498|SUPERIORITY||Risk Ratio (RR)|1.02||||0.7464|TWO_SIDED|95.0|0.91|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of ROP||1.14|0.91|0.7464
74063874|NCT01954082|147679499|SUPERIORITY||Risk Ratio (RR)|0.98||||0.7598|TWO_SIDED|95.0|0.83|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of Type 2 ROP or more severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of Type 2 ROP or more severe ROP.||1.14|0.83|0.7598
74063875|NCT01954082|147679500|SUPERIORITY||Risk Ratio (RR)|1.04||||0.8133|TWO_SIDED|95.0|0.74|1.48||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of severe IVH is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence severe IVH.||1.48|0.74|0.8133
74063876|NCT00755937|147679546|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|66.3||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
74063877|NCT00755937|147679547|SUPERIORITY_OR_OTHER||percentage (no inferential test)|72.5||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
74063878|NCT00755937|147679548|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|72.1||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
74063879|NCT00755937|147679549|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|60.3||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
74063880|NCT00755937|147679550|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|64.8||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
74063881|NCT00755937|147679551|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|72.1||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
74063882|NCT01223196|147679571|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in M/I. Statistical Analysis applies to (M/I) between Pioglitazone and Placebo after 6 months.||Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences 20), Chicago, IL, USA).||||0.04
74063883|NCT01223196|147679571|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups.||||||0.05
74063884|NCT01223196|147679572|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups.||Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).||||<0.05
74063885|NCT01223196|147679572|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Statistical Analysis applies toTNF (Tumor Necrosis Factor) alpha converting enzyme (TACE) activity between Pioglitazone and Placebo after 6 months.||Statistical analysis 2 also used 2-sided t-test similar to Statistical analysis -1||||<0.05
74063886|NCT01223196|147679573|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in Heamoglobin A1c between groups.||Mann-Whitney test was used to test differences Haemoglobin A1C between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).||||<0.05
74063887|NCT05180630|147679574|OTHER|||||||0.012||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to 0.01666667 (.05/3). Comparisons were total mean scores for Open dome condition, Vented dome condition, and Custom earmolds with dynamic venting|ANOVA|||Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for streamed music, but there was no analysis between groups.||||0.012
74063888|NCT05180630|147679575|OTHER|||||||0.154||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to 0.01666667 (.05/3).|ANOVA|||Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for own voice, but there was no analysis between groups.||||0.154
73882790|NCT05316597|147299673|SUPERIORITY|||||||0.82||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||||||0.82
74063889|NCT00709735|147679577|SUPERIORITY||Mean Difference (Final Values)|-13.0|||||TWO_SIDED|95.0|-30.0|4.0|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)|||4.0|-30.0|
74063890|NCT00709735|147679578|SUPERIORITY||Mean Difference (Final Values)|-12.7|||||TWO_SIDED|95.0|-27.4|1.9|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)|||1.9|-27.4|
73882791|NCT05316597|147299674|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.265|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.265
74063891|NCT00666718|147679585|NON_INFERIORITY_OR_EQUIVALENCE|"Assuming a drop-out rate after randomization of approximately 15%, the remaining 160 patients in each treatment group should allow confirmation of noninferiority with no true treatment difference and a noninferiority limit of 0.4% using the upper limit of a 2-sided 95% confidence interval (insulin lispro protamine suspension + insulin lispro minus insulin glargine+insulin lispro) at a significance level of 0.025 with 90% power."|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.11|0.31|||ANCOVA|||||0.31|-0.11|
74063892|NCT00666718|147679586|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||p-value is for Week 12 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment\*country+treatment\*week+baseline HbA1c\*treatment (unstructured covariance used).||||||0.4580
74063893|NCT00666718|147679586|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||p-value is for Week 24 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment\*country+treatment\*week+baseline HbA1c\*treatment (unstructured covariance used).||||||0.1070
74063894|NCT00666718|147679587|SUPERIORITY_OR_OTHER|||||||0.1333||95.0||||p-value is for HbA1c \<7.0%.|Fisher Exact|||||||0.1333
74063895|NCT00666718|147679587|SUPERIORITY_OR_OTHER|||||||0.1213||95.0||||p-value is for HbA1c \<=6.5%|Fisher Exact|||||||0.1213
74063896|NCT00666718|147679588|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|||||TWO_SIDED|95.0|-0.43|1.17|||Mixed Models Analysis|Morning Pre-Meal measurement = Treatment+country+week+treatment\*country + treatment\*week (unstructured covariance was used)||||1.17|-0.43|
73882792|NCT05316597|147299674|SUPERIORITY|||||||0.63||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||||||0.63
73882793|NCT05316597|147299675|SUPERIORITY||Median Difference (Final Values)|-0.34||||0.724|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.724
74063897|NCT00666718|147679588|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26|||||TWO_SIDED|95.0|-0.66|1.19|||Mixed Models Analysis|Morning Postprandial measurement = Treatment +country+week+treatment\*country + treatment\*week (unstructured covariance was used)||||1.19|-0.66|
74063898|NCT00666718|147679588|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|||||TWO_SIDED|95.0|-1.15|0.57|||Mixed Models Analysis|Midday Pre-Meal measurement = Treatment +country + week +treatment\*country + treatment\*week (unstructured covariance was used).||||0.57|-1.15|
74063899|NCT00666718|147679588|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|||||TWO_SIDED|95.0|-0.46|1.4|||Mixed Models Analysis|Midday Postprandial measurement = Treatment+country+week+treatment\*country + treatment\*week (unstructured covariance was used).||||1.40|-0.46|
74063900|NCT00666718|147679588|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|||||TWO_SIDED|95.0|-0.93|0.83|||Mixed Models Analysis|Evening Pre-Meal measurement = Treatment +country+week+treatment\*country + treatment\*week (unstructured covariance was used).||||0.83|-0.93|
74063901|NCT00666718|147679588|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|||||TWO_SIDED|95.0|-0.41|1.34|||Mixed Models Analysis|Evening Postprandial measurement = Treatment+country+week +treatment\*country + treatment\*week (unstructured covariance was used).||||1.34|-0.41|
73882794|NCT05316597|147299676|SUPERIORITY||Mean Difference (Final Values)|-2.85||||0.716|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.716
74063902|NCT00666718|147679588|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|||||TWO_SIDED|95.0|-0.67|0.96|||Mixed Models Analysis|0300 Hours measurement = Treatment+country+week+treatment\*country+treatment\*week (unstructured covariance was used).||||0.96|-0.67|
74063903|NCT00666718|147679589|SUPERIORITY_OR_OTHER|||||||0.5568||95.0||||p-value is for Fasting.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.5568
73882795|NCT05316597|147299677|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.852|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.852
74063904|NCT00666718|147679589|SUPERIORITY_OR_OTHER|||||||0.7523||95.0||||p-value is for Post-breakfast.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.7523
74063905|NCT00666718|147679589|SUPERIORITY_OR_OTHER|||||||0.6448||95.0||||p-value is for Post-lunch.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.6448
74063906|NCT00666718|147679589|SUPERIORITY_OR_OTHER|||||||0.9122||95.0||||p-value is for Post-dinner.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+ treatment\*country (Mediterranean, rest of Europe)||||||0.9122
74063907|NCT00666718|147679590|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|||||TWO_SIDED|95.0|-1.19|0.12|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.12|-1.19|
74063908|NCT00666718|147679590|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.2|0.11|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.11|-0.20|
74063909|NCT00666718|147679590|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|||||TWO_SIDED|95.0|-1.06|0.16|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.16|-1.06|
74063910|NCT00666718|147679590|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-0.86|0.06|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.06|-0.86|
74063911|NCT00666718|147679590|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|Hypoglycemia rate per 30 days=Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.12|-0.14|
74063912|NCT00666718|147679591|SUPERIORITY_OR_OTHER|||||||0.1701||95.0||||p-value is for \>=1 hypoglycemic episode.|Fisher Exact|||||||0.1701
74063913|NCT00666718|147679591|SUPERIORITY_OR_OTHER|||||||0.1727||95.0||||p-value is for \>=1 nocturnal hypoglycemic episode.|Fisher Exact|||||||0.1727
74063914|NCT00666718|147679591|SUPERIORITY_OR_OTHER|||||||0.2094||95.0||||p-value is for \>=1 non-nocturnal hypoglycemic episode.|Fisher Exact|||||||0.2094
74063915|NCT00666718|147679591|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||p-value is for \>=1 severe hypoglycemic episode.|Fisher Exact|||||||0.6230
74063916|NCT00666718|147679593|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|||||TWO_SIDED|95.0|-0.86|0.55|||ANCOVA|weight change from baseline = Treatment + country + baseline Hb1Ac + baseline weight + treatment\*HbA1c baseline value||||0.55|-0.86|
74063917|NCT00666718|147679594|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|||||TWO_SIDED|95.0|-8.33|12.68|||Mixed Models Analysis|Total daily insulin dose=Treatment+country+week+treatment\*country+ treatment\*week (unstructured covariance was used).||||12.68|-8.33|
74063918|NCT03496207|147679613|SUPERIORITY||Difference in Least Squares Means|-151.1|STANDARD_ERROR_OF_MEAN|49.53||0.003|TWO_SIDED|95.0|-249.59|-52.63|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||-52.63|-249.59|0.0030
74063919|NCT03496207|147679613|SUPERIORITY||Difference in Least Squares Means|-269.4|STANDARD_ERROR_OF_MEAN|48.48|<|0.0001|TWO_SIDED|95.0|-365.81|-173.03|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||-173.03|-365.81|<.0001
74063920|NCT03496207|147679614|SUPERIORITY||Difference in Least Squares Means|-13.9|STANDARD_ERROR_OF_MEAN|50.95||0.7851|TWO_SIDED|95.0|-113.85|86.06|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||86.06|-113.85|0.7851
74063921|NCT03496207|147679615|SUPERIORITY||Multiple Imputation Mean Difference|-223.2|STANDARD_ERROR_OF_MEAN|57.45|<|0.0001|TWO_SIDED|95.0|-335.83|-110.49||Comparison of baseline and final value|ANCOVA||Standard multiple imputations are done with imputed values that are within the range of the minimum and maximum observed values using linear regression including baseline measurements.|||-110.49|-335.83|<.0001
74063922|NCT00810615|147679652|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|A repeated measures model was designed so as to incorporate the adjust for the repeated (dependent) measures within individuals over time.||ANCOVA, baseline measurement was considered as a covariate and group (sham or 2.4 ATA), treatment (15 treatments, 30 treatments, and 6 weeks) as well as the interaction between group and treatment were considered as the independent variables.||||0.05
74063923|NCT00810615|147679664|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5455||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with one significant event (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
74063924|NCT00810615|147679665|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with two significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
74063925|NCT00810615|147679666|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1111||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with three significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
74063926|NCT00810615|147679667|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with four or more significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
74063927|NCT01255722|147679674|NON_INFERIORITY_OR_EQUIVALENCE|The clinical non-inferiority margin was set to -10% maximum difference with the best comparator (i.e. iopromide).|Mean Difference (Final Values)|-0.033||||0.05|TWO_SIDED|95.0|-0.088|0.021|||Chi-squared|||Iobitridol was compared to the best of the two comparators. The two-sided 95% confidence interval (CI) of the difference between both proportions (Iobitridol - Comparator) was computed and the lower limit of the CI compared to the clinical non-inferiority limit in the study. The non-inferiority of iobitridol over the best comparator was established if the lower limit of the two-sided 95% CI was equal to or higher than the clinical non-inferiority limit.||0.021|-0.088|0.05
74063928|NCT01255722|147679675|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher Exact|||||||0.750
74063929|NCT01255722|147679677|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
74063930|NCT01255722|147679678|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED||||||Fisher Exact|||||||0.109
74063931|NCT01255722|147679679|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Fisher Exact|||||||0.09
74063932|NCT02164539|147679680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
74063933|NCT02164539|147679680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
74063934|NCT02164539|147679680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
74063935|NCT02164539|147679680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
74063936|NCT02164539|147679680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.152|TWO_SIDED|95.0|-0.027|0.172|||Final dose response model|||||0.172|-0.027|0.152
74063937|NCT02164539|147679681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.01|TWO_SIDED|95.0|-1.7|-0.2|||ANCOVA|||||-0.2|-1.7|0.010
73882796|NCT05316597|147299678|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.166|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.166
73882797|NCT05316597|147299679|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.046|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.046
74063938|NCT02164539|147679681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.004|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.4|-1.9|0.004
74063939|NCT02164539|147679681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.083|TWO_SIDED|95.0|-1.4|0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||0.1|-1.4|0.083
74063940|NCT02164539|147679681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.014|TWO_SIDED|95.0|-1.5|-0.2|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.2|-1.5|0.014
74063941|NCT02164539|147679681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.031|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.1|-1.4|0.031
73882798|NCT05526716|147299696|NON_INFERIORITY|Serotype 3|Geometric Mean Titers Ratio (GMT Ratio)|0.84|||||TWO_SIDED|95.0|0.72|0.97||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.97|0.72|
73882799|NCT05526716|147299696|NON_INFERIORITY|Serotype 6A|GMT Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.94|0.66|
74063942|NCT02164539|147679682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.6|-1.7|||ANCOVA|||||-1.7|-4.6|<0.001
74063943|NCT02164539|147679682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.5|-1.6|||ANCOVA|||||-1.6|-4.5|<0.001
74063944|NCT02164539|147679682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.007|TWO_SIDED|95.0|-3.4|-0.6|||ANCOVA|||||-0.6|-3.4|0.007
74063945|NCT02164539|147679682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.002|TWO_SIDED|95.0|-3.2|-0.7|||ANCOVA|||||-0.7|-3.2|0.002
74063946|NCT02164539|147679682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.009|TWO_SIDED|95.0|-2.9|-0.4|||ANCOVA|||||-0.4|-2.9|0.009
74063947|NCT02164539|147679683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.1||||0.004||95.0|5.9|30.3|||ANCOVA|||||30.3|5.9|0.004
74063948|NCT02164539|147679683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.8|||<|0.001|TWO_SIDED|95.0|9.4|34.1|||ANCOVA|||||34.1|9.4|<0.001
74063949|NCT02164539|147679683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.7||||0.001|TWO_SIDED|95.0|7.7|31.7|||ANCOVA|||||31.7|7.7|0.001
74063950|NCT02164539|147679683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.8|||<|0.001|TWO_SIDED|95.0|14.1|35.4|||ANCOVA|||||35.4|14.1|<0.001
74063951|NCT02164539|147679683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.5|||<|0.001|TWO_SIDED|95.0|8.0|29.1|||ANCOVA|||||29.1|8.0|<0.001
74063952|NCT02164539|147679684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.264|TWO_SIDED|95.0|-0.034|0.125|||ANCOVA|||||0.125|-0.034|0.264
74063953|NCT02164539|147679684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.328|TWO_SIDED|95.0|-0.041|0.121|||ANCOVA|||||0.121|-0.041|0.328
74063954|NCT02164539|147679684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.534|TWO_SIDED|95.0|-0.054|0.103|||ANCOVA|||||0.103|-0.054|0.534
74063955|NCT02164539|147679684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.005||||0.895|TWO_SIDED|95.0|-0.065|0.075|||ANCOVA|||||0.075|-0.065|0.895
74063956|NCT02164539|147679684|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.076||||0.031|TWO_SIDED|95.0|0.007|0.146|||ANCOVA|||||0.146|0.007|0.031
74063957|NCT02164539|147679685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.088||||0.019|TWO_SIDED|95.0|-0.162|-0.014|||ANCOVA|||||-0.014|-0.162|0.019
74063958|NCT02164539|147679685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.091||||0.017|TWO_SIDED|95.0|-0.165|-0.016|||ANCOVA|||||-0.016|-0.165|0.017
74063959|NCT02164539|147679685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089||||0.017|TWO_SIDED|95.0|-0.162|-0.016|||ANCOVA|||||-0.016|-0.162|0.017
74063960|NCT02164539|147679685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.066|TWO_SIDED|95.0|-0.124|0.004|||ANCOVA|||||0.004|-0.124|0.066
74063961|NCT02164539|147679685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.163|||<|0.001|TWO_SIDED|95.0|-0.227|-0.099|||ANCOVA|||||-0.099|-0.227|<0.001
74063962|NCT02643966|147679686|OTHER|We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Year/Screen 1.|simple proportions|1.3||||0.005|TWO_SIDED|95.0|0.3|2.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||2.1|0.3|0.005
74063963|NCT02643966|147679686|OTHER|We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Years/Screens 2 \& 3.|simple proportions|1.0|||<|0.001|TWO_SIDED|95.0|0.4|1.5||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||1.5|0.4|<0.001
74063964|NCT02643966|147679687|OTHER|We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Year/Screen 1.|simple proportions|17.8||||0.005|TWO_SIDED|95.0|4.4|31.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||31.1|4.4|0.005
74063965|NCT02643966|147679687|OTHER|We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Years/Screens 2 and 3.|simple proportions|13.5|||<|0.001|TWO_SIDED|95.0|4.9|22.3||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added CDR from US of 1.1/1,000.Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||22.3|4.9|< 0.001
74063966|NCT02643966|147679689|OTHER|We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Year/Screen 1.|Slope|4.5|||<|0.001|TWO_SIDED|95.0|3.8|5.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||||5.1|3.8|< 0.001
74063967|NCT02643966|147679689|OTHER|We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Years/Screens 2 \& 3.|simple proportions|3.7|||<|0.001|TWO_SIDED|95.0|3.3|4.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||||4.1|3.3|< 0.001
74063968|NCT02441179|147679769|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Kruskal-Wallis|||||||0.006
74063969|NCT02441179|147679770|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Kruskal-Wallis|||||||0.012
74063970|NCT02441179|147679771|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Kruskal-Wallis|||||||0.16
74063971|NCT02441179|147679772|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
74063972|NCT02441179|147679773|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
74063973|NCT02441179|147679774|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.43
74063974|NCT02441179|147679775|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.55
74063975|NCT03162354|147679807|OTHER||Odds Ratio (OR)|0.64||||0.11|TWO_SIDED|95.0|0.37|1.11||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|We powered this hypothesis to detect a 17% increase (from 73% to 90%) in higher risk patients evaluated thoroughly for abuse at intervention sites, compared to baseline in prior PediBIRN studies. Generalized linear mixed-effects models were adopted to analyze 1,000 Monte Carlo datasets from simulation. For the target sample size of 304 higher risk patients (152 in each arm), the proportion of simulated datasets that yielded a statistically significant result for the primary hypothesis was 95.7%.||1.11|0.37|0.11
74063976|NCT03162354|147679808|OTHER||Odds Ratio (OR)|0.69||||0.49|TWO_SIDED|95.0|0.24|1.98||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||1.98|0.24|0.49
74063977|NCT03162354|147679809|OTHER||Odds Ratio (OR)|1.88||||0.22|TWO_SIDED|95.0|0.69|5.13||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||5.13|0.69|0.22
74063978|NCT03162354|147679810|OTHER||Odds Ratio (OR)|0.48||||0.01|TWO_SIDED|95.0|0.27|0.85||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||0.85|0.27|0.01
74063979|NCT03162354|147679811|OTHER||Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|95.0|0.46|2.6||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||2.60|0.46|0.84
74063980|NCT03162354|147679812|OTHER||Odds Ratio (OR)|1.84||||0.05|TWO_SIDED|95.0|1.0|3.38||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||3.38|1.00|0.05
74063981|NCT03162354|147679813|OTHER||Odds Ratio (OR)|1.22||||0.71|TWO_SIDED|95.0|0.43|3.49||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||3.49|0.43|0.71
74063982|NCT03162354|147679814|OTHER||Odds Ratio (OR)|1.04||||0.86|TWO_SIDED|95.0|0.7|1.53||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||1.53|0.70|0.86
74063983|NCT03162354|147679815|OTHER||Odds Ratio (OR)|2.02||||0.01|TWO_SIDED|95.0|1.16|3.52||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline prior studies to the cluster randomized trial|||3.52|1.16|0.01
74063984|NCT03162354|147679816|OTHER||Odds Ratio (OR)|0.42|||<|0.001|TWO_SIDED|95.0|0.26|0.67||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline in prior studies to the cluster randomized trial.|||0.67|0.26|<.001
74063985|NCT03162354|147679817|OTHER||Odds Ratio (OR)|0.46||||0.14|TWO_SIDED|95.0|0.16|1.31||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline in prior PediBIRN studies to the clinical trial.|||1.31|0.16|0.14
74063986|NCT03162354|147679819|OTHER||Odds Ratio (OR)|0.74||||0.57|TWO_SIDED|95.0|0.27|2.05||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||2.05|0.27|0.57
73882800|NCT05526716|147299696|NON_INFERIORITY|Serotype 7F|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.63|
74063987|NCT03162354|147679820|OTHER||Odds Ratio (OR)|0.63||||0.04|TWO_SIDED|95.0|0.4|0.99||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||0.99|0.40|0.04
73882801|NCT05526716|147299696|NON_INFERIORITY|Serotype 8|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.61|0.82||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.82|0.61|
74063988|NCT02176642|147679822|NON_INFERIORITY|We estimated that women in the placebo group would have mean reduction of 3 UUI episodes per day. Assuming 50% improvement in UUI episodes per day is a clinically significant improvement, we estimated the experimental group would have a mean reduction of 4.5 UUI episodes per day with a SD of 1.5 UUI episodes per day. To detect such a difference with 80% power and alpha 0.05, we would need 88 participants for our analysis. To allow for a 12% dropout rate, our goal was to enroll 100 women.||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
74063989|NCT02176642|147679823|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
74063990|NCT02176642|147679824|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
74063991|NCT02176642|147679825|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
74063992|NCT02176642|147679826|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
74063993|NCT02176642|147679827|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
74063994|NCT02176642|147679828|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
74063995|NCT02176642|147679829|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
74063996|NCT02176642|147679830|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
74063997|NCT00295620|147679834|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.425|TWO_SIDED|95.0|0.79|1.11|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a DFS event||1.11|0.79|0.425
74063998|NCT00295620|147679835|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.867|TWO_SIDED|95.0|0.83|1.25|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a death event||1.25|0.83|0.867
74063999|NCT00295620|147679836|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.052|TWO_SIDED|95.0|1.0|1.84|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a fracture||1.84|1.00|0.052
74064000|NCT00295620|147679837|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.678|TWO_SIDED|95.0|0.81|1.38|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of secondary carcinoma||1.38|0.81|0.678
74064001|NCT00295620|147679838|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.531|TWO_SIDED|95.0|0.75|1.77|||Log Rank|||Arm A: Anastrozole for 2 years Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of contralateral mammacarcinoma||1.77|0.75|0.531
74064002|NCT02989610|147679844|SUPERIORITY|Superiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 60%.|||||<|0.0001|||||||Clopper-Pearson method|||Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.||||<0.0001
74064003|NCT02989610|147679845|NON_INFERIORITY|Non-inferiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 40%.|||||<|0.0001|||||||Clopper-Pearson method|||Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.||||<0.0001
74064004|NCT02989610|147679846|SUPERIORITY|||||||1|||||||t-test, 1 sided|Paired t-test.||"Comparison of UPDRS part III on medication from 3 months using omnidirectional stimulation to 6 months using directional stimulation.~The p-value presented is calculated and does not represent the threshold. The statistical test used for this endpoint is single sided, and the observed difference was in the opposite direction of the tested difference, leading to a p-value that is equivalent to 1 within the significance of the statistical software used."||||1.0000
74064005|NCT04179474|147679847|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.55|||||TWO_SIDED|90.0|96.21|115.79|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||115.79|96.21|
74064006|NCT04179474|147679848|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.03|||||TWO_SIDED|90.0|89.55|123.19|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||123.19|89.55|
73882802|NCT05526716|147299696|NON_INFERIORITY|Serotype 9N|GMT Ratio|0.67|||||TWO_SIDED|95.0|0.57|0.79||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.79|0.57|
74064007|NCT04179474|147679849|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.38|||||TWO_SIDED|90.0|96.19|115.45|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||115.45|96.19|
74064008|NCT04179474|147679850|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|104.76|||||TWO_SIDED|90.0|89.68|122.38|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||122.38|89.68|
74064009|NCT04179474|147679851|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|103.86|||||TWO_SIDED|90.0|93.01|115.98|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means||115.98|93.01|
74064010|NCT04179474|147679852|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|99.55|||||TWO_SIDED|90.0|82.27|120.45|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||120.45|82.27|
74064011|NCT02556632|147679869|OTHER|||||||0.9306|||||||ANOVA|||||||0.9306
74064012|NCT02556632|147679870|OTHER|||||||0.8048|||||||Fisher Exact|||||||0.8048
74064013|NCT02556632|147679871|OTHER|||||||0.8591|||||||ANOVA|||||||0.8591
74064014|NCT04508621|147679874|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.115|TWO_SIDED|95.0|-0.6|0.1|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment difference = TNX-102 SL - Placebo|||0.1|-0.6|0.115
74064015|NCT04508621|147679875|SUPERIORITY|Patients with missing data considered non-responders.|Difference in Proportions|8.0||||0.038|TWO_SIDED|95.0|0.5|15.5|||Pearson Chi-Squared|||||15.5|0.5|0.038
74064016|NCT04508621|147679876|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.55||0.03|TWO_SIDED|95.0|-6.4|-0.3|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment difference = TNX-102 SL - Placebo|||-0.3|-6.4|0.030
74064017|NCT04508621|147679877|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.46||0.797|TWO_SIDED|95.0|-3.2|2.5|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||2.5|-3.2|0.797
74064018|NCT04508621|147679878|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.8||0.004|TWO_SIDED|95.0|-3.8|-0.7|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||-0.7|-3.8|0.004
74064019|NCT04508621|147679879|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.74||0.101|TWO_SIDED|95.0|-2.7|0.2|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||0.2|-2.7|0.101
74064020|NCT04508621|147679880|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.094|TWO_SIDED|95.0|-0.6|0.0|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||0.0|-0.6|0.094
74064021|NCT01083901|147679909|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANCOVA|Changes from baseline to 16 weeks were regressed on the baseline measurement.||The null hypothesis was that the changes in total body fat-free mass in response to resistance exercise training would not be different among the groups. The expected difference in fat-free mass between the Acetaminophen and Placebo groups was 1.8 +/- 1.0% with a 3.6 +/1 1.0% increase in fat-free mass in the Placebo group. The study was designed to achieve 96% power at the 0.05 level with 10 men in the acetaminophen and placebo groups.||||0.38
74064022|NCT01083901|147679910|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|The change in fat mass was regressed on the baseline measure.||||||0.23
74064023|NCT01083901|147679911|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANCOVA|Change in strength was regressed on baseline measures.||||||0.30
74064024|NCT01083901|147679912|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANCOVA|Changes in strength were regressed on the baseline measure.||||||0.37
74064025|NCT01625286|147679950|SUPERIORITY|A hazard ratio \< 1 favours AZD5363|Hazard Ratio (HR)|0.8||||0.308|TWO_SIDED|80.0|0.6|1.06||2-sided p-value|Regression, Cox|Cox PH model including treatment and PIK3CA status as factors/covariates||||1.06|0.60|0.308
74064026|NCT01625286|147679951|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.081|TWO_SIDED|80.0|-17.1|-0.8||1-sided p-value|ANCOVA|||||-0.8|-17.1|0.081
74064027|NCT01625286|147679957|SUPERIORITY||Odds Ratio (OR)|1.53||||0.139|TWO_SIDED|80.0|0.93|2.54||1-sided p-value|Regression, Logistic|including treatment and PIK3CA status as factors/covariates||||2.54|0.93|0.139
74064028|NCT01625286|147679958|SUPERIORITY|A hazard ratio \< 1 favours AZD5363|Hazard Ratio (HR)|0.77||||0.482|TWO_SIDED|80.0|0.48|1.24||2-sided p-value|Log Rank|Cox PH model including treatment and PIK3CA status as factors/covariates||||1.24|0.48|0.482
74064029|NCT00828516|147679959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_DEVIATION|0.96|<|0.001||95.0||||This was not adjusted for multiple comparisons|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."|There will be no improvement in MYMOP profile score after 6 acupuncture treatments.||||<0.001
73882803|NCT05526716|147299696|NON_INFERIORITY|Serotype 10A|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.91||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.91|0.65|
73882804|NCT05526716|147299696|NON_INFERIORITY|Serotype 11A|GMT Ratio|0.64|||||TWO_SIDED|95.0|0.54|0.75||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.75|0.54|
74064030|NCT00828516|147679960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|STANDARD_DEVIATION|0.94|<|0.001||95.0||||There will be no improvement in MYMOP profile score after 12 treatments|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."|||||<0.001
74064031|NCT03958071|147679964|OTHER||Absolute standardized differences (ASD)|-0.1027||||0.281|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.2810
74064032|NCT03958071|147679964|OTHER||Absolute standardized differences (ASD)|-0.078||||0.1421|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.1421
74064033|NCT03958071|147679964|OTHER||Absolute standardized differences (ASD)|0.0159||||0.0048|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.0048
74064034|NCT03958071|147679966|OTHER||Absolute standardized differences (ASD)|0.0214||||0.7681|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.7681
74064035|NCT03958071|147679966|OTHER||Absolute standardized differences (ASD)|0.371|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
74064036|NCT03958071|147679966|OTHER||Absolute standardized differences (ASD)|0.349|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
74064037|NCT03958071|147679967|OTHER||Absolute standardized differences (ASD)|-0.1257||||0.1659|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.1659
74064038|NCT03958071|147679967|OTHER||Absolute standardized differences (ASD)|0.1566||||0.0112|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.0112
74064039|NCT03958071|147679967|OTHER||Absolute standardized differences (ASD)|0.3019|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
73882805|NCT05526716|147299696|NON_INFERIORITY|Serotype 12F|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.62|0.94||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.94|0.62|
73882806|NCT05526716|147299696|NON_INFERIORITY|Serotype 15A|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.60|
74064040|NCT03958071|147679968|OTHER||Absolute standardized differences (ASD)|-0.0209||||0.326|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.3260
74064041|NCT03958071|147679968|OTHER||Absolute standardized differences (ASD)|-0.2694|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
74064042|NCT03958071|147679968|OTHER||Absolute standardized differences (ASD)|-0.2352|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
74064043|NCT03958071|147679969|OTHER||Absolute standardized differences (ASD)|0.09||||0.2042|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.2042
74064044|NCT03958071|147679969|OTHER||Absolute standardized differences (ASD)|0.21|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
74064045|NCT03958071|147679969|OTHER||Absolute standardized differences (ASD)|0.11||||0.02|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.02
74064046|NCT03958071|147679970|OTHER||Absolute standardized differences (ASD)|0.0241||||0.7395|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.7395
74064047|NCT03958071|147679970|OTHER||Absolute standardized differences (ASD)|0.1644||||0.0017|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.0017
74064048|NCT03958071|147679970|OTHER||Absolute standardized differences (ASD)|0.1403||||0.0034|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.0034
74064049|NCT04084028|147679976|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
74064050|NCT04084028|147679977|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
74064051|NCT04084028|147679978|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
74064052|NCT04084028|147679979|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||.19
74064053|NCT04084028|147679980|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||.77
74064054|NCT04084028|147679981|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||.06
74064055|NCT03712137|147680010|SUPERIORITY||Responder Rate Difference|30.9||||0.0001|TWO_SIDED|95.0|15.33|46.54|||Multiple Imputation|The procedure used to perform Multiple Imputation is PROC MIANALYZE in SAS with normal approximation||||46.54|15.33|0.0001
74064056|NCT03712137|147680013|SUPERIORITY||Mean Difference (Final Values)|45.9|||<|0.0001|TWO_SIDED|95.0|40.45|51.28|||Paired T-test|||||51.28|40.45|<0.0001
74064057|NCT02082912|147680028|SUPERIORITY||F statistic|0.216||||0.651|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.651
74064058|NCT02082912|147680029|SUPERIORITY||F statistic|0.633||||0.447|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.447
74064059|NCT02082912|147680030|SUPERIORITY||F statistic|0.557||||0.471|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.471
74064060|NCT04440163|147680033|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was greater than (\>) minus (-)10 percent (%), the non-inferiority was concluded.|Difference in percentage of participants|2.5|||||TWO_SIDED|95.0|-0.2|6.0|||Based on Miettinen and Nurminen method.|||MenA||6.0|-0.2|
74064061|NCT04440163|147680033|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|41.0|||||TWO_SIDED|95.0|34.4|47.5||||||MenC||47.5|34.4|
74064062|NCT04440163|147680033|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|24.3|||||TWO_SIDED|95.0|18.8|30.4||||||MenW||30.4|18.8|
74064063|NCT04440163|147680033|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|23.8|||||TWO_SIDED|95.0|18.0|30.1||||||MenY||30.1|18.0|
74064064|NCT04440163|147680034|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-3.2|||||TWO_SIDED|95.0|-6.5|0.5||||||MenA||0.5|-6.5|
74064065|NCT04440163|147680034|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-0.9|||||TWO_SIDED|95.0|-4.6|3.3||||||MenC||3.3|-4.6|
74064066|NCT04440163|147680034|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|0.7|||||TWO_SIDED|95.0|-2.2|4.3||||||MenW||4.3|-2.2|
74064067|NCT04440163|147680034|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-0.7|||||TWO_SIDED|95.0|-4.6|3.8||||||MenY||3.8|-4.6|
74064068|NCT04440163|147680035|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|9.6|||||TWO_SIDED|95.0|4.2|15.2||||||||15.2|4.2|
74064069|NCT04440163|147680036|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|4.0|||||TWO_SIDED|95.0|-0.7|8.9||||||A22||8.9|-0.7|
74064070|NCT04440163|147680036|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-1.0|4.3||||||A56||4.3|-1.0|
73882807|NCT05526716|147299696|NON_INFERIORITY|Serotype 15C|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.87|0.58|
74064071|NCT04440163|147680036|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|10.9|||||TWO_SIDED|95.0|5.2|16.6||||||B24||16.6|5.2|
74064072|NCT04440163|147680036|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage|7.3|||||TWO_SIDED|95.0|2.9|11.9||||||B44||11.9|2.9|
73882808|NCT05526716|147299696|NON_INFERIORITY|Serotype 16F|GMT Ratio|0.69|||||TWO_SIDED|95.0|0.59|0.81||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.81|0.59|
74064073|NCT04440163|147680068|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.7|||||TWO_SIDED|95.0|-1.0|5.3||||||MenA||5.3|-1.0|
73882809|NCT05526716|147299696|NON_INFERIORITY|Serotype 17F|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.62|0.86||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.86|0.62|
73882810|NCT05526716|147299696|NON_INFERIORITY|Serotype 19A|GMT Ratio|0.75|||||TWO_SIDED|95.0|0.65|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.65|
74064074|NCT04440163|147680068|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|10.5|||||TWO_SIDED|95.0|3.0|17.9||||||MenC||17.9|3.0|
74064075|NCT04440163|147680068|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|6.3|||||TWO_SIDED|95.0|-0.1|13.1||||||MenW||13.1|-0.1|
74064076|NCT04440163|147680068|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|11.4|||||TWO_SIDED|95.0|5.0|18.2||||||MenY||18.2|5.0|
74064077|NCT04440163|147680069|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-2.2|||||TWO_SIDED|95.0|-5.2|1.4||||||MenA||1.4|-5.2|
74064078|NCT04440163|147680069|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-1.3|||||TWO_SIDED|95.0|-4.9|2.9||||||MenC||2.9|-4.9|
74064079|NCT04440163|147680069|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.0|||||TWO_SIDED|95.0|-1.6|4.6||||||MenW||4.6|-1.6|
74064080|NCT04440163|147680069|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|0.6|||||TWO_SIDED|95.0|-3.0|5.0||||||MenY||5.0|-3.0|
74064081|NCT01430182|147680070|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 1 sided|unpaired||||||0.37
74064082|NCT03137082|147680071|SUPERIORITY||||||<|0.03|||||||Mixed Models Analysis|||||||<0.03
74064083|NCT03137082|147680072|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.1
74064084|NCT03137082|147680074|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
74064085|NCT03137082|147680075|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74064086|NCT03137082|147680076|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
74064087|NCT03137082|147680077|SUPERIORITY||||||<|0.03|||||||Mixed Models Analysis|||||||<.03
74064088|NCT03137082|147680078|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.1
74064089|NCT03137082|147680079|SUPERIORITY||||||<|0.3|||||||Mixed Models Analysis|||||||<0.3
74064090|NCT03137082|147680080|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
74064091|NCT03137082|147680081|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.4
74064092|NCT03137082|147680082|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
74064093|NCT03137082|147680083|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.2
74064094|NCT00467818|147680116|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||t-test, 2 sided|||||||1.0
74064095|NCT00467818|147680117|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||0.10
74064096|NCT00467818|147680119|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.5|TWO_SIDED||||||Mixed Models Analysis|||||||<0.5
74064097|NCT00467818|147680120|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.5
74064098|NCT01017029|147680126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.482||||0.1043|TWO_SIDED|95.0|0.922|2.383|||Regression, Cox|||||2.383|0.922|0.1043
74064099|NCT01017029|147680128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.847||||0.0398|TWO_SIDED|95.0|1.029|3.315|||Regression, Cox|||||3.315|1.029|0.0398
74064100|NCT01017029|147680130|SUPERIORITY_OR_OTHER|||||||0.0234|||||||Fisher Exact|||CMV infections||||0.0234
74064101|NCT01017029|147680131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.403||||0.1966|TWO_SIDED|95.0|0.839|2.347|||Regression, Cox|||||2.347|0.839|0.1966
74064102|NCT02660385|147680144|SUPERIORITY||Effect Size|-0.6||||0.0002|TWO_SIDED||||||Generalized Linear Mixed Model (GLMM)|GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.||||||0.0002
74064103|NCT02660385|147680145|SUPERIORITY|||||||0.0723||||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0723
74064104|NCT02660385|147680146|SUPERIORITY||effect size|0.42||||0.011|TWO_SIDED||||||GLMM|GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.||||||0.0110
74064105|NCT02660385|147680147|SUPERIORITY||effect size|-0.7|||<|0.0001|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||<0.0001
74064106|NCT02660385|147680148|SUPERIORITY||effect size|-0.12||||0.4356|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.4356
74064107|NCT02660385|147680149|SUPERIORITY|||||||0.0148||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0148
74064108|NCT02660385|147680150|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
74064109|NCT02660385|147680151|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
74064110|NCT02660385|147680152|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
74064111|NCT02660385|147680153|SUPERIORITY|||||||0.6358||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.6358
74064112|NCT02660385|147680154|SUPERIORITY||effect size|0.35||||0.0318|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0318
74064113|NCT02660385|147680155|SUPERIORITY|||||||0.2722||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.2722
73882811|NCT05526716|147299696|NON_INFERIORITY|Serotype 20A|GMT Ratio|0.74|||||TWO_SIDED|95.0|0.63|0.87||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.87|0.63|
74064114|NCT02660385|147680156|SUPERIORITY||effect size|-0.27||||0.0954|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0954
74064115|NCT02660385|147680157|SUPERIORITY|||||||0.4222||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.4222
74064116|NCT02660385|147680158|SUPERIORITY||effect size|0.09||||0.5781|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.5781
74064117|NCT02660385|147680159|SUPERIORITY|||||||0.1238||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.1238
74064118|NCT02660385|147680160|SUPERIORITY||effect size|-0.3||||0.0558|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0558
74064119|NCT02660385|147680161|SUPERIORITY|||||||0.023||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0230
74064120|NCT02660385|147680162|SUPERIORITY||effect size|0.06||||0.4597|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.4597
74064121|NCT02660385|147680163|SUPERIORITY|||||||0.1943||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.1943
74064122|NCT02660385|147680164|SUPERIORITY||effect size|-0.23||||0.0027|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0027
74064123|NCT02660385|147680165|SUPERIORITY|||||||0.0792||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0792
74064124|NCT02660385|147680166|SUPERIORITY||effect size|0.13||||0.0656|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0656
74064125|NCT02660385|147680167|SUPERIORITY|||||||0.2174||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.2174
74064126|NCT02660385|147680168|SUPERIORITY||effect size|0.07||||0.7028|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.7028
74064127|NCT02660385|147680169|SUPERIORITY|||||||0.0509||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0509
74064128|NCT02660385|147680170|SUPERIORITY||Mean Difference (Final Values)|275.0|STANDARD_ERROR_OF_MEAN|1525.0||0.955|TWO_SIDED|95.0|-3288.0|2739.0|||t-test, 2 sided|||||2739|-3288|0.955
74064129|NCT02660385|147680171|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
74064130|NCT02660385|147680172|SUPERIORITY||effect size|-0.05||||0.7496|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.7496
74064131|NCT02660385|147680173|SUPERIORITY||effect size|0.06||||0.3821|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.3821
74064132|NCT02660385|147680174|SUPERIORITY|||||||0.7204||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.7204
74064133|NCT03547531|147680205|OTHER||||||>|0.05|||||||t-test, 2 sided|independent t-test||Null hypothesis: the mean of plaque index between groups are not different|the statistical analysis used in this study is independent t-test|||>0.05
73882812|NCT05526716|147299696|NON_INFERIORITY|Serotype 22F|GMT Ratio|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.91|0.65|
74064134|NCT03547531|147680206|OTHER|this data is analyzed using independent t-test|||||>|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test|||>0.05
74064135|NCT03547531|147680207|OTHER|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of plaque index between groups|this data is analyzed using independent t-test|||<0.05
74064136|NCT03547531|147680208|OTHER|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test|||<0.05
74064137|NCT02117479|147680217|OTHER||Hazard Ratio (HR)|0.969|||||TWO_SIDED|95.0|0.747|1.256||||||||1.256|0.747|
74064138|NCT02117479|147680218|OTHER||Hazard Ratio (HR)|1.056|||||TWO_SIDED|95.0|0.827|1.348||||||||1.348|0.827|
74064139|NCT01453374|147680226|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
74064140|NCT01453374|147680227|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
74064141|NCT01453374|147680228|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
74064142|NCT01453374|147680234|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED||||||Fisher Exact|||||||<0.10
74064143|NCT02981602|147680274|OTHER|||||||0.116||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.116
74064144|NCT02981602|147680274|OTHER||||||<|0.001||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||<0.001
74064145|NCT02981602|147680274|OTHER|||||||0.573||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.573
74064146|NCT02981602|147680275|OTHER|||||||0.609||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.609
74064147|NCT02981602|147680275|OTHER|||||||0.141||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.141
74064148|NCT02981602|147680276|OTHER|Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group||||||0.245|||||||ANCOVA|||||||0.245
74064149|NCT02981602|147680276|OTHER|||||||0.001||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.001
73882813|NCT05526716|147299696|NON_INFERIORITY|Serotype 23A|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.63|0.96||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.96|0.63|
73882814|NCT05526716|147299696|NON_INFERIORITY|Serotype 23B|GMT Ratio|0.56|||||TWO_SIDED|95.0|0.44|0.72||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.72|0.44|
74064150|NCT02981602|147680276|OTHER|||||||0.762||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.762
74064151|NCT02981602|147680277|OTHER|||||||0.141||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.141
74064152|NCT02981602|147680277|OTHER|||||||0.081||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.081
74064153|NCT02981602|147680277|OTHER|||||||0.616||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.616
74064154|NCT02981602|147680280|OTHER|||||||0.763||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.763
74064155|NCT02981602|147680280|OTHER|||||||0.804||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.804
74064156|NCT02981602|147680281|OTHER|||||||0.372||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.372
74064157|NCT02981602|147680281|OTHER|||||||0.954||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.954
74064158|NCT00386100|147680283|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.669|-0.305||No adjustment for multiple comparisons|ANCOVA|ANCOVA with terms for treatment, region, gender, and baseline value with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.305|-0.669|<0.0001
74064159|NCT00386100|147680284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.3||No adjustment for multiple comparisons|Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model|||-0.30|-0.69|<0.0001
74064160|NCT00386100|147680285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.0046|TWO_SIDED|95.0|1.18|2.46||Hb1AC \<= 6.5%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32.|Odds of having an HbA1c \<= 6.5% at Week 80 on Avandamet compared to Metformin.|||2.46|1.18|0.0046
74064161|NCT00386100|147680285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.59|||<|0.0001|TWO_SIDED|95.0|1.75|3.81||Hb1AC \< 7%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32|Odds of having an HbA1c \<7% at Week 80 on Avandamet compared to Metformin|||3.81|1.75|<0.0001
74064162|NCT00386100|147680286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15|||<|0.0001||95.0|-1.54|-0.77|||Repeated measures analysis|Terms for baseline, region, treatment, pre-screening Hb1Ac strata, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model|||-0.77|-1.54|<0.0001
74064163|NCT00386100|147680287|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.07|||<|0.001|TWO_SIDED|95.0|-1.425|-0.71||No adjustment for multiple comparisons|ANCOVA|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.710|-1.425|<0.001
74064164|NCT00386100|147680288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.47|||<|0.0001|TWO_SIDED|95.0|2.94|6.81||FPG \<=6.1 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32.|Odds of having an FPG \<=6.1 mmol/l at Week 80 on Avandamet compared to Metformin|||6.81|2.94|<0.0001
74064165|NCT00386100|147680288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.25|4.92||FPG \<=7 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac, and baseline with LOCF from Week 32.|Odds of having an FPG \<=7 mmol/l at Week 80 on Avandamet compared to Metformin|||4.92|2.25|<0.0001
74064166|NCT00386100|147680289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.74|||Regression, Cox|Cox proportional hazard regression with terms for treatment, region, baseline Hb1Ac strata, and gender||||0.74|0.45|<0.0001
74064167|NCT00386100|147680290|SUPERIORITY_OR_OTHER||Percent difference from metformin|5.97||||0.0006|TWO_SIDED|95.0|2.522|9.526||Total cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||9.526|2.522|0.0006
74064168|NCT00386100|147680290|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.71||||0.056|TWO_SIDED|95.0|2.486|15.304||LDL cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||15.304|2.486|0.056
74064169|NCT00386100|147680290|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.58||||0.072|TWO_SIDED|95.0|-0.232|5.47||HDL cholesterol. No adjustment for multiple comparison. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||5.470|-0.232|0.072
74064170|NCT00386100|147680290|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.743||||0.835|TWO_SIDED|95.0|-6.056|8.035||Triglycerides. No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||8.035|-6.056|0.835
74064171|NCT00386100|147680291|SUPERIORITY_OR_OTHER||Percent difference from metformin|102.24|||<|0.0001|TWO_SIDED|95.0|79.23|128.19||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||128.19|79.23|<0.0001
74064172|NCT00386100|147680292|SUPERIORITY_OR_OTHER||Percent difference from metformin|-8.2||||0.138|TWO_SIDED|95.0|-18.04|2.82||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||2.82|-18.04|0.1380
74064173|NCT00386100|147680293|SUPERIORITY_OR_OTHER||Percent difference from metformin|-11.308||||0.0342|TWO_SIDED|95.0|-20.617|-0.899||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||-0.899|-20.617|0.0342
74064174|NCT00386100|147680294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.7||||0.0042|TWO_SIDED|95.0|-56.666|-0.99||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline.|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.99|-56.666|0.0042
74064175|NCT00386100|147680295|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.229||||0.0006|TWO_SIDED|95.0|-0.359|-0.099||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.099|-0.359|0.0006
74064176|NCT00386100|147680296|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.4||||0.7148|TWO_SIDED|95.0|-9.87|16.34||HOMA-B. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||16.34|-9.87|0.7148
74064177|NCT00386100|147680296|SUPERIORITY_OR_OTHER||percent difference from metformin|31.14|||<|0.001|TWO_SIDED|95.0|14.82|49.78||HOMA-S. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||49.78|14.82|<0.001
73882815|NCT05526716|147299696|NON_INFERIORITY|Serotype 24F|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.86||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.86|0.61|
74064178|NCT00386100|147680297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|80.85||||0.319|TWO_SIDED|95.0|-79.035|240.744|||Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, pre-screening Hb1AC, time, and treatment by time interaction||||240.744|-79.035|0.319
74064179|NCT00386100|147680299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0012|TWO_SIDED|95.0|-3.5|-0.9||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.9|-3.5|0.0012
74064180|NCT00386100|147680299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0031|TWO_SIDED|95.0|-2.7|-0.6||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-2.7|0.0031
74064181|NCT00386100|147680299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.0308|TWO_SIDED|95.0|-2.0|-0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-2.0|0.0308
74064182|NCT00386100|147680299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.0954|TWO_SIDED|95.0|-3.7|0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.3|-3.7|0.0954
74064183|NCT00386100|147680299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.0015|TWO_SIDED|95.0|-4.7|-1.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.2|-4.7|0.0015
74064184|NCT00386100|147680299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0045|TWO_SIDED|95.0|-3.9|-0.7||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.7|-3.9|0.0045
74064185|NCT00386100|147680299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0005|TWO_SIDED|95.0|-3.3|-1.0||Female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.0|-3.3|0.0005
74064186|NCT00386100|147680299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.2363|TWO_SIDED|95.0|-4.6|1.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.2|-4.6|0.2363
74064187|NCT00386100|147680299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.0161|TWO_SIDED|95.0|-5.9|-0.6||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-5.9|0.0161
74064188|NCT00386100|147680299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.0338|TWO_SIDED|95.0|-4.9|-0.2||Postmenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.9|0.0338
74064189|NCT00386100|147680299|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.6||||0.002|TWO_SIDED|95.0|-4.1|-1.0||Postmenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.0|-4.1|0.0020
74064190|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0005|TWO_SIDED|95.0|-2.3|-0.7||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.7|-2.3|0.0005
73882816|NCT05526716|147299696|NON_INFERIORITY|Serotype 31|GMT Ratio|0.68|||||TWO_SIDED|95.0|0.56|0.83||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.83|0.56|
74064191|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.011|TWO_SIDED|95.0|-1.7|-0.2||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-1.7|0.0110
74064192|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0618|TWO_SIDED|95.0|-1.1|0.0||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-1.1|0.0618
73882817|NCT05526716|147299696|NON_INFERIORITY|Serotype 33F|GMT Ratio|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||1.01|0.70|
73882818|NCT05526716|147299696|NON_INFERIORITY|Serotype 35B|GMT Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.89||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of serotypes is \>0.50.||0.89|0.67|
73882819|NCT05526716|147299697|NON_INFERIORITY|A/H1N1|GMT Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.97||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.97|0.70|
74064193|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.011|TWO_SIDED|95.0|-2.3|-0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-2.3|0.0110
74064194|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.0272|TWO_SIDED|95.0|-1.9|-0.1||Male population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-1.9|0.0272
74064195|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.0337|TWO_SIDED|95.0|-1.6|-0.1||Male population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-1.6|0.0337
74064196|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.7||||0.0152|TWO_SIDED|95.0|-3.1|-0.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-3.1|0.0152
74064197|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.057|TWO_SIDED|95.0|-2.4|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-2.4|0.0570
74064198|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.2||||0.0296|TWO_SIDED|95.0|-4.3|-0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.3|0.0296
74064199|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.0155|TWO_SIDED|95.0|-4.4|-0.5||Premenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.5|-4.4|0.0155
74064200|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.4||||0.587|TWO_SIDED|95.0|-1.7|1.0||Premenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-1.7|0.5870
74064201|NCT00386100|147680300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.1854|TWO_SIDED|95.0|-3.6|0.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.7|-3.6|0.1854
74064202|NCT00386100|147680301|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.9||||0.0038|TWO_SIDED|95.0|-3.2|-0.6||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-3.2|0.0038
74064203|NCT00386100|147680301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0134|TWO_SIDED|95.0|-2.7|-0.3||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-2.7|0.0134
73882820|NCT05526716|147299697|NON_INFERIORITY|A/H3N2|GMT Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.93||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.93|0.67|
74064204|NCT00386100|147680301|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.0967|TWO_SIDED|95.0|-1.5|0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.1|-1.5|0.0967
74064205|NCT00386100|147680301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0512|TWO_SIDED|95.0|-3.0|0.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-3.0|0.0512
74064206|NCT00386100|147680301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.033|TWO_SIDED|95.0|-4.6|-0.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.6|0.0330
74064207|NCT00386100|147680301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.0547|TWO_SIDED|95.0|-3.7|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-3.7|0.0547
74064208|NCT00386100|147680301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1||||0.0613|TWO_SIDED|95.0|-6.3|0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.2|-6.3|0.0613
73882821|NCT05526716|147299697|NON_INFERIORITY|B/Victoria|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.95||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.95|0.70|
74064209|NCT00386100|147680301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.5||||0.1369|TWO_SIDED|95.0|-3.9|1.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.7|-3.9|0.1369
73882822|NCT05526716|147299697|NON_INFERIORITY|B/Yamagata|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.0||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||1.00|0.78|
74064210|NCT00386100|147680302|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.126|TWO_SIDED|95.0|-1.7|0.2||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.2|-1.7|0.1260
74064211|NCT00386100|147680302|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.3117|TWO_SIDED|95.0|-2.2|0.7||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.7|-2.2|0.3117
74064212|NCT00386100|147680302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.1776|TWO_SIDED|95.0|-2.2|0.4||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.4|-2.2|0.1776
74064213|NCT00386100|147680302|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.2||||0.2259|TWO_SIDED|95.0|-3.2|0.8||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.8|-3.2|0.2259
74064214|NCT00386100|147680302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.384|TWO_SIDED|95.0|-2.8|1.1||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.1|-2.8|0.3840
74064215|NCT00386100|147680303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.6102|TWO_SIDED|95.0|-1.9|1.1||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.1|-1.9|0.6102
74064216|NCT00386100|147680303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.3445|TWO_SIDED|95.0|-2.9|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-2.9|0.3445
74064217|NCT00386100|147680303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9735|TWO_SIDED|95.0|-2.4|2.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||2.3|-2.4|0.9735
74064218|NCT00386100|147680303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.4861|TWO_SIDED|95.0|-5.8|2.9||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||2.9|-5.8|0.4861
74064219|NCT00386100|147680303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.877|TWO_SIDED|95.0|-3.5|4.0||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||4.0|-3.5|0.8770
74064220|NCT00386100|147680304|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.2||||0.7015|TWO_SIDED|95.0|-1.5|1.0||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-1.5|0.7015
74064221|NCT00386100|147680304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.6767|TWO_SIDED|95.0|-0.7|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-0.7|0.6767
74064222|NCT00386100|147680304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.4199|TWO_SIDED|95.0|-3.4|1.5||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.5|-3.4|0.4199
74064223|NCT00386100|147680304|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.5||||0.2526|TWO_SIDED|95.0|-16.4|5.4||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||5.4|-16.4|0.2526
74064224|NCT00386100|147680304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.4153|TWO_SIDED|95.0|-1.8|0.8||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.8|-1.8|0.4153
74064225|NCT00386100|147680305|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.168||||0.7895|TWO_SIDED|95.0|-1.066|1.417||Overall population, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.417|-1.066|0.7895
74064226|NCT00386100|147680305|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.745||||0.4155|TWO_SIDED|95.0|-1.064|2.587||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||2.587|-1.064|0.4155
73882823|NCT05526716|147299698|OTHER|Serotype 3|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.8|1.02||||||||1.02|0.80|
73882824|NCT05526716|147299698|OTHER|Serotype 6A|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.79|1.11||||||||1.11|0.79|
73882825|NCT05526716|147299698|OTHER|Serotype 7F|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.67|0.9||||||||0.90|0.67|
73882826|NCT05526716|147299698|OTHER|Serotype 8|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.95||||||||0.95|0.70|
73882827|NCT05526716|147299698|OTHER|Serotype 9N|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.05||||||||1.05|0.75|
73882828|NCT05526716|147299698|OTHER|Serotype 10A|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.94||||||||0.94|0.67|
74064227|NCT00386100|147680305|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.452||||0.6223|TWO_SIDED|95.0|-2.253|1.382||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.382|-2.253|0.6223
74064228|NCT00386100|147680305|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.638||||0.5908|TWO_SIDED|95.0|-3.043|1.826||Premenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.826|-3.043|0.5908
74064229|NCT00386100|147680305|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.155||||0.9154|TWO_SIDED|95.0|-3.037|2.814||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||2.814|-3.037|0.9154
74064230|NCT00386100|147680306|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.467||||0.8682|TWO_SIDED|95.0|-14.785|20.818||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||20.818|-14.785|0.8682
74064231|NCT00386100|147680306|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.328||||0.974|TWO_SIDED|95.0|-18.308|23.214||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||23.214|-18.308|0.9740
74064232|NCT00386100|147680306|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.986||||0.8378|TWO_SIDED|95.0|-22.997|37.735||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||37.735|-22.997|0.8378
74064233|NCT00386100|147680306|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.19||||0.7889|TWO_SIDED|95.0|-43.839|108.422||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||108.422|-43.839|0.7889
74064234|NCT00386100|147680306|SUPERIORITY_OR_OTHER||Percent difference from metformin|3.344||||0.88|TWO_SIDED|95.0|-34.853|63.935||Postmenopausal females, Week 80. Log transformed.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||63.935|-34.853|0.8800
74064235|NCT00386100|147680307|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.2168||||0.9069|TWO_SIDED|95.0|-17.6057|24.3392||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||24.3392|-17.6057|0.9069
74064236|NCT00386100|147680307|SUPERIORITY_OR_OTHER||Percent difference from metformin|-10.1648||||0.5118|TWO_SIDED|95.0|-35.6298|25.3742||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||25.3742|-35.6298|0.5118
74064237|NCT00386100|147680307|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.8777||||0.5816|TWO_SIDED|95.0|-20.2636|48.6692||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||48.6692|-20.2636|0.5816
74064238|NCT00386100|147680307|SUPERIORITY_OR_OTHER||Percent difference from metformin|-1.0031||||0.9587|TWO_SIDED|95.0|-35.928|52.959||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||52.9590|-35.9280|0.9587
74064239|NCT00386100|147680307|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.7614||||0.8337|TWO_SIDED|95.0|-34.4741|67.4901||Postmenopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||67.4901|-34.4741|0.8337
74064240|NCT00386100|147680308|SUPERIORITY_OR_OTHER||Percent difference from metformin|7.527||||0.7041|TWO_SIDED|95.0|-26.773|57.892||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||57.892|-26.773|0.7041
74064241|NCT00386100|147680308|SUPERIORITY_OR_OTHER||Percent difference from metformin|30.211||||0.6403|TWO_SIDED|95.0|-61.586|341.371||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||341.371|-61.586|0.6403
74064242|NCT00386100|147680308|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.929||||0.8474|TWO_SIDED|95.0|-17.015|25.198||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||25.198|-17.015|0.8474
73882829|NCT05526716|147299698|OTHER|Serotype 11A|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.96||||||||0.96|0.72|
73882830|NCT05526716|147299698|OTHER|Serotype 12F|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.01||||||||1.01|0.69|
73882831|NCT05526716|147299698|OTHER|Serotype 15A|GMC Ratio|0.75|||||TWO_SIDED|95.0|0.63|0.9||||||||0.90|0.63|
73882832|NCT05526716|147299698|OTHER|Serotype 15C|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.71|1.02||||||||1.02|0.71|
73882833|NCT05526716|147299698|OTHER|Serotype 16F|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.99||||||||0.99|0.70|
73882834|NCT05526716|147299698|OTHER|Serotype 17F|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
73882835|NCT05526716|147299698|OTHER|Serotype 19A|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.93||||||||0.93|0.71|
73882836|NCT05526716|147299698|OTHER|Serotype 20A|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.97||||||||0.97|0.70|
73882837|NCT05526716|147299698|OTHER|Serotype 22F|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.1||||||||1.10|0.80|
73882838|NCT05526716|147299698|OTHER|Serotype 23A|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.7|1.03||||||||1.03|0.70|
73882839|NCT05526716|147299698|OTHER|Serotype 23B|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||||1.02|0.72|
73882840|NCT05526716|147299698|OTHER|Serotype 24F|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.69|1.05||||||||1.05|0.69|
73882841|NCT05526716|147299698|OTHER|Serotype 31|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
73882842|NCT05526716|147299698|OTHER|Serotype 33F|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.69|0.94||||||||0.94|0.69|
73882843|NCT05526716|147299698|OTHER|Serotype 35B|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
73882844|NCT00807911|147299720|OTHER||Hazard Ratio (HR)|0.657||||0.047|TWO_SIDED|95.0|0.434|0.994|||t-test, 1 sided|||||0.994|0.434|0.047
73882845|NCT00807911|147299721|OTHER||Hazard Ratio (HR)|0.602||||0.04|TWO_SIDED|95.0|0.371|0.977|||t-test, 1 sided|||||0.977|0.371|0.040
73882846|NCT00807911|147299722|OTHER||Hazard Ratio (HR)|0.744||||0.47|TWO_SIDED|95.0|0.334|1.657|||t-test, 1 sided|||||1.657|0.334|0.47
73882847|NCT00807911|147299723|OTHER||Hazard Ratio (HR)|0.456||||0.036|TWO_SIDED|95.0|0.215|0.97|||t-test, 1 sided|||||0.970|0.215|0.036
73882848|NCT03547518|147299728|SUPERIORITY|||||||0.111|||||||t-test, 2 sided|||||||0.111
73882849|NCT03547518|147299729|SUPERIORITY|||||||0.487|||||||t-test, 2 sided|||||||0.487
73882850|NCT03547518|147299730|SUPERIORITY|||||||0.0393|||||||t-test, 2 sided|||||||0.0393
73882851|NCT03547518|147299731|SUPERIORITY|||||||0.242|||||||t-test, 2 sided|||||||0.242
74064243|NCT00386100|147680309|SUPERIORITY_OR_OTHER||Percent difference from metformin|5.7||||0.486|TWO_SIDED|95.0|-9.6|23.6||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||23.6|-9.6|0.4860
74064244|NCT00386100|147680309|SUPERIORITY_OR_OTHER||Percent difference from metformin|12.3||||0.3791|TWO_SIDED|95.0|-13.7|46.1||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||46.1|-13.7|0.3791
74064245|NCT00386100|147680309|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.0||||0.7065|TWO_SIDED|95.0|-15.3|27.6||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||27.6|-15.3|0.7065
74064246|NCT00386100|147680309|SUPERIORITY_OR_OTHER||Percent difference from metformin|32.1||||0.1381|TWO_SIDED|95.0|-9.5|92.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||92.7|-9.5|0.1381
74064247|NCT00386100|147680309|SUPERIORITY_OR_OTHER||Percent difference from metformin|-4.3||||0.7195|TWO_SIDED|95.0|-25.4|22.7||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||22.7|-25.4|0.7195
74064248|NCT00386100|147680310|SUPERIORITY_OR_OTHER||Percent difference from metformin|-3.0||||0.5595|TWO_SIDED|95.0|-12.3|7.4||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||7.4|-12.3|0.5595
74064249|NCT00386100|147680310|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.0||||0.9125|TWO_SIDED|95.0|-15.3|20.4||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||20.4|-15.3|0.9125
73882852|NCT03547518|147299732|SUPERIORITY|||||||0.855|||||||t-test, 2 sided|||||||0.855
74064250|NCT00386100|147680310|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.8||||0.9122|TWO_SIDED|95.0|-14.0|14.5||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||14.5|-14.0|0.9122
74064251|NCT00386100|147680310|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.6||||0.7435|TWO_SIDED|95.0|-21.2|38.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||38.7|-21.2|0.7435
73882853|NCT00072462|147299741|SUPERIORITY||Hazard Ratio (HR)|0.88|STANDARD_DEVIATION|0.12||0.33|TWO_SIDED|95.0|0.67|1.14|||Regression, Cox|Univariate||||1.14|0.67|0.33
73882854|NCT00072462|147299741|SUPERIORITY||Hazard Ratio (HR)|0.87|STANDARD_DEVIATION|0.12||0.33|TWO_SIDED|95.0|0.66|1.15|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.15|0.66|0.33
73882855|NCT00072462|147299742|SUPERIORITY||Hazard Ratio (HR)|0.72|STANDARD_DEVIATION|0.12||0.06|TWO_SIDED|95.0|0.52|1.01|||Regression, Cox|Univariate||||1.01|0.52|0.06
73882856|NCT00072462|147299742|SUPERIORITY||Hazard Ratio (HR)|0.74|STANDARD_DEVIATION|0.13||0.09|TWO_SIDED|95.0|0.52|1.05|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.05|0.52|0.09
73882857|NCT00072462|147299743|SUPERIORITY||Hazard Ratio (HR)|1.64|STANDARD_DEVIATION|0.54||0.13|TWO_SIDED|95.0|0.75|2.84|||Regression, Cox|Univariate||||2.84|0.75|0.13
73882858|NCT00072462|147299743|SUPERIORITY||Hazard Ratio (HR)|1.46|STANDARD_DEVIATION|0.5||0.26|TWO_SIDED|95.0|0.75|2.84|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||2.84|0.75|0.26
73882859|NCT00072462|147299744|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.97|TWO_SIDED|95.0|0.21|5.11|||Regression, Cox|Univariate||||5.11|0.21|0.97
73882860|NCT00072462|147299744|SUPERIORITY||Hazard Ratio (HR)|1.08|STANDARD_DEVIATION|0.88||0.93|TWO_SIDED|95.0|0.22|5.36|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||5.36|0.22|0.93
73882861|NCT00072462|147299745|SUPERIORITY||Hazard Ratio (HR)|0.93|STANDARD_DEVIATION|0.17||0.67|TWO_SIDED|95.0|0.65|1.32|||Regression, Cox|Univariate||||1.32|0.65|0.67
73882862|NCT00072462|147299745|SUPERIORITY||Hazard Ratio (HR)|0.85|STANDARD_DEVIATION|0.16||0.38|TWO_SIDED|95.0|0.59|1.22|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.22|0.59|0.38
73882863|NCT02927301|147299752|SUPERIORITY||Other/Percentage|20.3|||<|0.0001|ONE_SIDED|95.0|14.9||||binomial test||||||14.900|<.0001
73882864|NCT02927301|147299753|SUPERIORITY||Risk Difference (RD)|11.41||||0.0358|ONE_SIDED|80.0|5.279||||Fisher Exact||||||5.279|0.0358
73882865|NCT02927301|147299754|SUPERIORITY||Risk Difference (RD)|16.363||||0.0395|ONE_SIDED|80.0|6.509||||Chi-squared||||||6.509|0.0395
73882866|NCT02201524|147299770|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-5.08|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|90.0|-9.15|-1.01||||||PF-04965842 200 mg vs Placebo: Longitudinal analysis of covariance (LANCOVA) model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.01|-9.15|
73882867|NCT02201524|147299770|SUPERIORITY_OR_OTHER||LS mean difference|-5.61|STANDARD_ERROR_OF_MEAN|2.375|||TWO_SIDED|90.0|-9.61|-1.62||||||PF-04965842 400 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.62|-9.61|
74064252|NCT00386100|147680310|SUPERIORITY_OR_OTHER||Percent difference from metformin|-7.5||||0.3897|TWO_SIDED|95.0|-23.0|11.0||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||11.0|-23.0|0.3897
74064253|NCT00386100|147680311|SUPERIORITY_OR_OTHER||Percent difference from metformin|-2.83||||0.5176|TWO_SIDED|95.0|-10.97|6.06||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||6.06|-10.97|0.5176
74064254|NCT00386100|147680311|SUPERIORITY_OR_OTHER||Percent difference from metformin|-6.26||||0.362|TWO_SIDED|95.0|-18.62|7.97||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||7.97|-18.62|0.3620
74064255|NCT00386100|147680311|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.72||||0.9115|TWO_SIDED|95.0|-11.39|14.48||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||14.48|-11.39|0.9115
74064256|NCT00386100|147680311|SUPERIORITY_OR_OTHER||Percent difference from metformin|-13.51||||0.1956|TWO_SIDED|95.0|-30.35|8.31||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||8.31|-30.35|0.1956
73882868|NCT02201524|147299770|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|STANDARD_ERROR_OF_MEAN|2.506|||TWO_SIDED|90.0|-14.19|-5.77||||||PF-04965842 200 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.77|-14.19|
74064257|NCT00386100|147680311|SUPERIORITY_OR_OTHER||Percent difference from metformin|3.75||||0.6749|TWO_SIDED|95.0|-13.09|23.85||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||23.85|-13.09|0.6749
74064258|NCT02020785|147680314|SUPERIORITY|Main analyses were intention-to-treat using mixed effects models allowing intercepts to vary for each individual. Carryover effects were examined by using treatment by assignment-order interaction terms. Pre-specified sensitivity analyses were conducted excluding patients who were non-compliant, prior to data analysis: 1st, noncompliance based on missing product pickups and follow-up visits; 2nd, suspected poor compliance (\< 250 mg difference between the higher and lower period).\]|Mean Difference (Final Values)|0.143||||0.05|TWO_SIDED|95.0|-0.025|0.34||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (14.3%, 95% CI: -2.5%, 34.0%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed 24-hour urine albumin excretion|Sample size for this study was calculated using the xsampsi module in STATA, based on a previous study with repeat 24-hour urine collections (standard deviation, 1.04). At an α level of 0.05, we anticipated that a sample size of 30 participants with mean albuminuria of 100 mg/d would result in \>80% power to detect a 13% difference in log- transformed albuminuria between the higher and lower phosphorus additive periods.||0.34|-0.025|0.05
74064259|NCT02020785|147680315|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.05|TWO_SIDED|95.0|-0.059|0.136||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (3.4%, 95% CI: -5.9%, 13.6%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed fibroblast growth factor 23|||0.136|-0.059|0.05
74064260|NCT02020785|147680316|SUPERIORITY||mean difference (during each period)|-1.1||||0.05|TWO_SIDED|95.0|-4.1|1.9||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis|||||1.9|-4.1|0.05
74064261|NCT02020785|147680317|SUPERIORITY||mean difference (during each period)|-0.8||||0.05|TWO_SIDED|95.0|-2.7|1.0||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis|||||1.0|-2.7|0.05
74064262|NCT00701935|147680323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|4.432||0.8252|TWO_SIDED|95.0|-9.92|7.95||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline abdominal visceral fat.||"The power calculation is based on a two-sided t-test and significance level of 0.05.~Hypotheses for sample size:~Power: 80% Drop-out rate: 20% Difference in the percentage change in abdominal visceral fat from baseline to 6 months between exenatide and placebo: 10% Common standard deviation: 15%~94 patients are needed to attain the 37 patients randomized and analyzed in each group."||7.95|-9.92|0.8252
74064263|NCT00701935|147680324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|3.193||0.5207|TWO_SIDED|95.0|-8.53|4.39||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total abdominal fat.||||4.39|-8.53|0.5207
74064264|NCT00701935|147680325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.71|STANDARD_ERROR_OF_MEAN|2.687||0.1755|TWO_SIDED|95.0|-9.15|1.73||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline subcutaneous abdominal fat.||||1.73|-9.15|0.1755
74064265|NCT00701935|147680326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.155|<|0.0001|TWO_SIDED|95.0|-1.19|-0.57||p-values were not adjusted for multiple comparisons.|ANCOVA|ANCOVA analysis included the following factors: treatment, gender, investigator and baseline HbA1c||||-0.57|-1.19|<0.0001
74064266|NCT00701935|147680328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|0.491||0.0073|TWO_SIDED|95.0|-2.38|-0.4||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline fasting plasma glucose.||||-0.40|-2.38|0.0073
74064267|NCT00701935|147680329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|0.725||0.0035|TWO_SIDED|95.0|-3.66|-0.76||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline body weight.||||-0.76|-3.66|0.0035
74064268|NCT00701935|147680332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.248||0.4145|TWO_SIDED|95.0|-0.71|0.3||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total cholesterol||||0.30|-0.71|0.4145
74064269|NCT00701935|147680333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.279||0.4007|TWO_SIDED|95.0|-0.8|0.33||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline triglycerides||||0.33|-0.80|0.4007
74064270|NCT00701935|147680334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.048||0.7915|TWO_SIDED|95.0|-0.08|0.11||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline HDL cholesterol||||0.11|-0.08|0.7915
74064271|NCT00701935|147680335|SUPERIORITY_OR_OTHER||Ratio|3.28|STANDARD_ERROR_OF_MEAN|2.63||0.1388|TWO_SIDED|95.0|0.68|15.77||p-values were not adjusted for multiple comparisons.|Regression, Linear|Generalized linear model was used with the assumption of an underlying Poisson distribution and the logarithm of exposure (years) as offset variable.||Event rate per subject year was calculated for each subject : (number of events observed from a subject/exposure from a subject)\*365.25 where exposure = last post-baseline visit date - baseline visit date.||15.77|0.68|0.1388
74064272|NCT01783483|147680370|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Comparison of mean CT scan scores.||||<0.0001
73882869|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-9.32|STANDARD_ERROR_OF_MEAN|8.291|||TWO_SIDED|90.0|-23.19|4.56||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||4.56|-23.19|
74064273|NCT01783483|147680371|SUPERIORITY_OR_OTHER|||||||0.0007|||||||t-test, 2 sided|||||||0.0007
74064274|NCT01783483|147680372|SUPERIORITY_OR_OTHER|||||||0.0539|||||||t-test, 2 sided|||At Rest||||0.0539
73882870|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-11.19|STANDARD_ERROR_OF_MEAN|8.177|||TWO_SIDED|90.0|-24.87|2.5||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.50|-24.87|
74064275|NCT01783483|147680372|SUPERIORITY_OR_OTHER|||||||0.0015|||||||t-test, 2 sided|||After Forced Coughing||||0.0015
74064276|NCT01783483|147680373|SUPERIORITY_OR_OTHER|||||||0.2125|||||||t-test, 2 sided|||At Rest||||0.2125
74064277|NCT01783483|147680373|SUPERIORITY_OR_OTHER|||||||0.0014|||||||t-test, 2 sided|||After Forced Coughing||||0.0014
74064278|NCT01783483|147680374|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 2 sided|||At Rest||||0.0049
74064279|NCT01783483|147680374|SUPERIORITY_OR_OTHER|||||||0.0183|||||||t-test, 2 sided|||After Forced Coughing||||0.0183
74064280|NCT01783483|147680375|SUPERIORITY_OR_OTHER|||||||0.6653|||||||t-test, 2 sided|||At Rest||||0.6653
74064281|NCT01783483|147680375|SUPERIORITY_OR_OTHER|||||||0.2295|||||||t-test, 2 sided|||After Forced Coughing||||0.2295
74064282|NCT01783483|147680377|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||Index (Day 0 to Hospital Discharge)||||0.370
74064283|NCT01783483|147680378|SUPERIORITY_OR_OTHER|||||||0.778|||||||t-test, 2 sided|||From Hospital Discharge to 3-week||||0.778
74064284|NCT01783483|147680379|SUPERIORITY_OR_OTHER|||||||0.055|||||||t-test, 2 sided|||From 3-week to 6-week post-op||||0.055
74064285|NCT01783483|147680381|SUPERIORITY_OR_OTHER|||||||0.113|||||||t-test, 2 sided|||From 3 month to 6-month post op||||0.113
74064286|NCT03398928|147680382|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74064287|NCT03398928|147680383|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
74064288|NCT03398928|147680386|SUPERIORITY|||||||0.002||||||The statistical analysis applies to all the rows|Chi-squared|||||||0.002
74064289|NCT03398928|147680387|SUPERIORITY|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
74064290|NCT00947518|147680392|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.99
74064291|NCT00947518|147680393|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||||||0.46
74064292|NCT00947518|147680394|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
74064293|NCT00947518|147680395|SUPERIORITY||||||<|0.05|||||||Chi-squared||||For comparison of categorical variables among the three groups, Chi2 test followed by Bonferroni's correction was used.|||<0.05
74064294|NCT00370396|147680407|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix-Synflorix minus Prevenar-Prevenar\] in terms of percentages of subjects reporting rectal fever \>39.0°C was computed.|Difference in percentage|-4.43|||||TWO_SIDED|95.0|-11.85|-0.21||||||Analysis aimed at demonstrating the non-inferiority of Synflorix™ vs Prevenar™ vaccine, both co-administered with Infanrix hexa™ vaccine, in terms of post-immunization febrile reactions with rectal fever \> 39.0°C.||-0.21|-11.85|
74064295|NCT03567239|147680474|OTHER|"The PIADS is broken into 3 subgroups - Competence, Adaptability, and Self-Esteem. The minimum possible score is -3 and the maximum possible score is 3 for each subgroup - with positive 3 being the best. The 7-Point Likert scale was used in response to the question The device provided increased my ability to … in relation to the custom need they had. A response of 1 = Strongly disagree and 7 = strongly agree."|||||||||||||||||Median values: Overall = 2.42, Competence = 2.58, Adaptability = 2.33, Self-Esteem = 2.00, Likert = 7|||
74064296|NCT03567239|147680475|OTHER|||||||||||||||||The NASA Task Load Index ranges from 1 to 21 with the lower the score the better.|Median vales: Overall = 4.83, Mental demand = 11, Physical demand = 4, Temporal demand = 6, Performance = 3, Effort = 3, Frustration = 5.|||
74064297|NCT03567239|147680476|OTHER|Median QUEST scores: Overall = 4.33, Device = 4.38, Services = 4.25.||||||||||||||||The QUEST (Quebec User Evaluation of Satisfaction with Assistive Technology) evaluates a patient's satisfaction with various assistive technologies. It has two subgroups, Device and Service on a scale of 1-5 with 5 being the best score.|Median QUEST scores: Overall = 4.33, Device = 4.38, Services = 4.25.|||
74064298|NCT00725725|147680494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5299||||0.3934|TWO_SIDED|95.0|-2.0781|5.138|||Mixed Models Analysis|||||5.1380|-2.0781|0.3934
74064299|NCT00725725|147680494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2667||||0.3515|TWO_SIDED|95.0|-1.4665|4.0|||Mixed Models Analysis|||||4.0000|-1.4665|0.3515
74064300|NCT00725725|147680495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8246||||0.3597|TWO_SIDED|95.0|-5.8307|2.1815|||Mixed Models Analysis|||||2.1815|-5.8307|0.3597
74064301|NCT00725725|147680495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4414||||0.777|TWO_SIDED|95.0|-3.5952|2.7124|||Mixed Models Analysis|||||2.7124|-3.5952|0.7770
74064302|NCT00725725|147680496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3356||||0.2683|TWO_SIDED|95.0|-1.8933|6.5644|||Mixed Models Analysis|||||6.5644|-1.8933|0.2683
74064303|NCT00725725|147680496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1317||||0.0844|TWO_SIDED|95.0|-0.4518|6.7152|||Mixed Models Analysis|||||6.7152|-0.4518|0.0844
74064304|NCT00725725|147680500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3456||||0.8894|TWO_SIDED|95.0|-4.6211|5.3124|||Mixed Models Analysis|||||5.3124|-4.6211|0.8894
74064305|NCT00725725|147680500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0417||||0.3765|TWO_SIDED|95.0|-2.5526|6.636|||Mixed Models Analysis|||||6.6360|-2.5526|0.3765
74064306|NCT00725725|147680501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2502||||0.8073|TWO_SIDED|95.0|-11.4963|8.9958|||Mixed Models Analysis|||||8.9958|-11.4963|0.8073
74064307|NCT00725725|147680501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0291||||0.661|TWO_SIDED|95.0|-7.2132|11.2714|||Mixed Models Analysis|||||11.2714|-7.2132|0.6610
74064308|NCT00725725|147680502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7296||||0.7895|TWO_SIDED|95.0|-4.7291|6.1883|||Mixed Models Analysis|||||6.1883|-4.7291|0.7895
74064309|NCT00725725|147680502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.526||||0.5488|TWO_SIDED|95.0|-3.5495|6.6015|||Mixed Models Analysis|||||6.6015|-3.5495|0.5488
74064310|NCT00725725|147680503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2766||||0.6516|TWO_SIDED|95.0|-6.9269|4.3738|||Mixed Models Analysis|||||4.3738|-6.9269|0.6516
74064311|NCT00725725|147680503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1867||||0.0256|TWO_SIDED|95.0|-11.5864|-0.7869|||Mixed Models Analysis|||||-0.7869|-11.5864|0.0256
74064312|NCT03909971|147680509|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74064313|NCT02450760|147680542|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
74064314|NCT02450760|147680543|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
74064315|NCT02450760|147680547|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
74064316|NCT02450760|147680548|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
74064317|NCT02450760|147680549|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
74064318|NCT03053622|147680554|OTHER||Ratio of Geometric Least Squares Means|0.996|||||TWO_SIDED|90.0|0.807|1.23||||||||1.23|0.807|
74064319|NCT03053622|147680554|OTHER||Ratio of Geometric Least Squares Means|0.729|||||TWO_SIDED|90.0|0.591|0.898||||||||0.898|0.591|
74064320|NCT03053622|147680554|OTHER||Ratio of Geometric Least Squares Means|0.422|||||TWO_SIDED|90.0|0.343|0.518||||||||0.518|0.343|
74064321|NCT03053622|147680554|OTHER||Ratio of Geometric Least Squares Means|0.307|||||TWO_SIDED|90.0|0.249|0.379||||||||0.379|0.249|
74064322|NCT03053622|147680555|OTHER||Ratio of Geometric Least Squares Means|0.986|||||TWO_SIDED|90.0|0.81|1.2||||||||1.20|0.810|
74064323|NCT03053622|147680555|OTHER||Ratio of Geometric Least Squares Means|0.753|||||TWO_SIDED|90.0|0.619|0.916||||||||0.916|0.619|
74064324|NCT03053622|147680556|OTHER||Median Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.1|48.4||||||||48.40|-0.10|
74064325|NCT03053622|147680556|OTHER||Median Difference (Final Values)|0.25|||||TWO_SIDED|90.0|-0.25|23.97|||||"In this outcome, the median difference is not calculated by subtracting two observations, it is derived by Hodges-Lehmann approach to estimating location shift. This method will give the value of 0.25."|||23.97|-0.25|
74064326|NCT00581386|147680560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.125||||0.013||95.0|1.27|7.67|||Regression, Logistic|Logistic regression Number of obs = 217, LR chi2(2)=10.89, Prob\>chi2=0.0043,Log likelihood = -112.87788, Pseudo R2=0.0460|this is a simple odds ratio|||7.67|1.27|0.013
74064327|NCT00581386|147680560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.003||95.0|1.57|9.29|||Odds ratio|||||9.29|1.57|0.003
74064328|NCT00581386|147680561|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.006||||0.006||95.0|||||t-test, 2 sided|||||||0.006
74064329|NCT00581386|147680562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.088||||0.003||95.0|1.728|14.99|||Regression, Logistic|||||14.99|1.728|0.003
74064330|NCT00581386|147680562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.22||||0.0004||95.0|2.419|21.527|||Regression, Logistic|||||21.527|2.419|0.0004
74064331|NCT01355523|147680564|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Chi-squared|||||||0.008
74064332|NCT01355523|147680564|SUPERIORITY_OR_OTHER||Number need to treat|2.95|||||TWO_SIDED|95.0|1.703|11.024||||||||11.024|1.703|
74064333|NCT01355523|147680564|SUPERIORITY_OR_OTHER||Relative Risk|0.25|||||TWO_SIDED|95.0|0.076|0.797||||||||0.797|0.076|
74064334|NCT01355523|147680565|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|||||||0.125
74064335|NCT01355523|147680566|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Fisher Exact|||||||0.460
74064336|NCT01355523|147680567|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Chi-squared|||||||0.002
74064337|NCT01355523|147680568|SUPERIORITY_OR_OTHER|||||||0.264||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.264
74064338|NCT01355523|147680569|SUPERIORITY_OR_OTHER|||||||0.351||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.351
74064339|NCT01355523|147680570|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.446
74064340|NCT01355523|147680571|SUPERIORITY_OR_OTHER|||||||0.122||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.122
74064341|NCT01355523|147680572|SUPERIORITY_OR_OTHER|||||||0.907||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.907
74064342|NCT01355523|147680573|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.555
74064343|NCT01355523|147680574|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.930
74064344|NCT01355523|147680575|SUPERIORITY_OR_OTHER|||||||0.386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.386
74064345|NCT01355523|147680576|SUPERIORITY_OR_OTHER|||||||0.241||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.241
74064346|NCT01355523|147680577|SUPERIORITY_OR_OTHER|||||||0.339||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.339
74064347|NCT01355523|147680578|SUPERIORITY_OR_OTHER|||||||0.578||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.578
74064348|NCT01355523|147680579|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.000
74064349|NCT02595528|147680646|SUPERIORITY||Least Squares (LS)|-2.5543||||0.0029|||||||Mixed model for repeated measures|||AGN-190584 Quadratic||||0.0029
74064350|NCT02595528|147680646|SUPERIORITY||Least Squares (LS)|6.6961|||<|0.0001|||||||Mixed model for repeated measures|||AGN-190584 Linear||||<0.0001
74064351|NCT02595528|147680646|SUPERIORITY||Least Squares (LS)|-69.89||||0.4126|||||||Mixed model for repeated measures|||AGN-199201 Quadratic||||0.4126
74064352|NCT02595528|147680646|SUPERIORITY||Least Squares (LS)|10.5017||||0.3752|||||||Mixed model for repeated measures|||AGN-199201 Linear||||0.3752
74064353|NCT00948025|147680757|OTHER|Mann-Whitney U test was used to derive p-values.||||||0.0433||||||"1. a priori threshold for statistical significance set at p\<0.05.~2. the p-value was not adjusted for multiple comparisons."|Wilcoxon (Mann-Whitney)|||"1. P-value comparing static 2-point discrimination per visit derived from mixed linear modeling of longitudinal data.~2. P-Value is based on Mann-Whitney U test."||||0.0433
74064354|NCT02292433|147680799|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.96|STANDARD_ERROR_OF_MEAN|4.841||0.0032|TWO_SIDED|90.0|-28.93|-10.98|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-10.98|-28.93|0.0032
74064355|NCT02292433|147680799|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.06|STANDARD_ERROR_OF_MEAN|3.172|<|0.0001|TWO_SIDED|90.0|-46.77|-35.35|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-35.35|-46.77|<0.0001
74064356|NCT02292433|147680800|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.18|STANDARD_ERROR_OF_MEAN|2.851||0.0006|TWO_SIDED|90.0|-17.16|-7.21|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-7.21|-17.16|0.0006
74064357|NCT02292433|147680800|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.81|STANDARD_ERROR_OF_MEAN|2.821|<|0.0001|TWO_SIDED|90.0|-30.73|-20.88|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-20.88|-30.73|<0.0001
74064358|NCT02292433|147680801|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.521|STANDARD_ERROR_OF_MEAN|0.7237||0.0447|TWO_SIDED|90.0|-2.752|-0.29|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.290|-2.752|0.0447
74064359|NCT02292433|147680801|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.949|STANDARD_ERROR_OF_MEAN|0.7249||0.0119|TWO_SIDED|90.0|-3.183|-0.716|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.716|-3.183|0.0119
74064360|NCT02292433|147680801|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.967|STANDARD_ERROR_OF_MEAN|2.3324||0.6873|TWO_SIDED|90.0|-5.195|3.261|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||3.261|-5.195|0.6873
74064361|NCT02292433|147680801|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.439|STANDARD_ERROR_OF_MEAN|0.9533||0.0659|TWO_SIDED|90.0|-4.502|-0.377|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.377|-4.502|0.0659
74064362|NCT02292433|147680801|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.358|STANDARD_ERROR_OF_MEAN|1.5994||0.4031|TWO_SIDED|90.0|-4.079|1.363|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||1.363|-4.079|0.4031
74064363|NCT02292433|147680801|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.766|STANDARD_ERROR_OF_MEAN|1.5951||0.0254|TWO_SIDED|90.0|-6.479|-1.052|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-1.052|-6.479|0.0254
74064364|NCT02292433|147680802|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.069||0.0067|TWO_SIDED|90.0|-0.33|-0.09|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.09|-0.33|0.0067
74064365|NCT02292433|147680802|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.071||0.0282|TWO_SIDED|90.0|-0.29|-0.05|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.05|-0.29|0.0282
74064366|NCT02292433|147680802|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.118||0.7877|TWO_SIDED|90.0|-0.18|0.25|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.25|-0.18|0.7877
74064367|NCT02292433|147680802|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.156||0.5064|TWO_SIDED|90.0|-0.17|0.39|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.39|-0.17|0.5064
74064368|NCT02292433|147680802|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.293||0.4072|TWO_SIDED|90.0|-0.75|0.25|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.25|-0.75|0.4072
74064369|NCT02292433|147680802|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.295||0.1422|TWO_SIDED|90.0|-0.95|0.06|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.06|-0.95|0.1422
74064370|NCT03101293|147680803|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% confidence intervals (CIs).|LS Mean Ratio|1.343||||0.0058|TWO_SIDED|90.0|1.146|1.574|||ANOVA|||||1.574|1.146|0.0058
74064371|NCT03101293|147680804|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.121||||0.1763|TWO_SIDED|90.0|0.969|1.298|||ANOVA|||||1.298|0.969|0.1763
74064372|NCT03101293|147680805|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.154||||0.2745|TWO_SIDED|90.0|0.929|1.433|||ANOVA|||||1.433|0.929|0.2745
74064373|NCT03182920|147680829|SUPERIORITY||Ratio of geometric least squares means|1.21|||||TWO_SIDED|90.0|0.962|1.52||||||||1.52|0.962|
74064374|NCT03182920|147680830|SUPERIORITY||Ratio of geometric least squares means|1.26|||||TWO_SIDED|90.0|1.03|1.55||||||||1.55|1.03|
74064375|NCT04378010|147680907|OTHER||LS mean difference|1.88|STANDARD_ERROR_OF_MEAN|1.788||0.454|TWO_SIDED|95.0|-3.479|7.239|||Mixed model repeated measures|||||7.239|-3.479|0.454
74064376|NCT04378010|147680907|OTHER||LS mean difference|-0.439|STANDARD_ERROR_OF_MEAN|1.553||0.848|TWO_SIDED|95.0|-5.458|4.579|||Mixed model repeated measures|||||4.579|-5.458|0.848
74064377|NCT04378010|147680918|OTHER||LS mean difference|-11.718|STANDARD_ERROR_OF_MEAN|7.052||0.114|TWO_SIDED|95.0|-26.342|2.906|||ANCOVA|||||2.906|-26.342|0.114
74064378|NCT04378010|147680918|OTHER||LS mean difference|-11.261|STANDARD_ERROR_OF_MEAN|6.879||0.099|TWO_SIDED|95.0|-24.723|2.2|||ANCOVA|||||2.200|-24.723|0.099
74064379|NCT04378010|147680919|OTHER||LS mean difference|1.05|STANDARD_ERROR_OF_MEAN|0.331||0.003|TWO_SIDED|95.0|0.365|1.736|||ANCOVA|||||1.736|0.365|0.003
74064380|NCT04378010|147680919|OTHER||LS mean difference|0.591|STANDARD_ERROR_OF_MEAN|0.315||0.064|TWO_SIDED|95.0|-0.035|1.216|||ANCOVA|||||1.216|-0.035|0.064
74064381|NCT04378010|147680923|OTHER||LS mean difference|12.986|STANDARD_ERROR_OF_MEAN|5.472||0.04|TWO_SIDED|95.0|0.608|25.363|||Mixed model repeated measures|||||25.363|0.608|0.040
74064382|NCT04378010|147680923|OTHER||LS mean difference|7.211|STANDARD_ERROR_OF_MEAN|5.724||0.242|TWO_SIDED|95.0|-4.997|19.418|||Mixed model repeated measures|||||19.418|-4.997|0.242
74064383|NCT02314520|147680969|SUPERIORITY|||||||0.271||||||0.05 is the threshold for significance for this primary outcome.|Fisher Exact|||||||0.271
74064384|NCT00423488|147681023|SUPERIORITY_OR_OTHER_LEGACY||least-squares means|-11.5||||0.005||95.0|-19.4|-3.5|||ANOVA|The analysis of variance (ANOVA) model included term of treatment effect. If more than one basal value was available, the latest was used.||||-3.5|-19.4|0.005
74064385|NCT00363129|147681026|SUPERIORITY_OR_OTHER|||||||0.43|||||||Chi-squared|||||||0.43
74064386|NCT00363129|147681027|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||0.49
74064387|NCT00363129|147681028|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
74064388|NCT03125915|147681031|SUPERIORITY||Beta|-3.62||||0.03|TWO_SIDED|95.0|-6.78|-0.46||A multi-level latent growth curve (LGC) with a intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-leve latent growth curve||For 1-Month Follow-Up, substance use module (SUM) among those who did not view CT Video|||-0.46|-6.78|.03
74064389|NCT03125915|147681031|SUPERIORITY||Beta|-1.67||||0.18|TWO_SIDED|95.0|-4.1|0.76||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did view the CT video.|||0.76|-4.10|.18
74064390|NCT03125915|147681031|SUPERIORITY||Beta|-0.35||||0.75|TWO_SIDED|95.0|-2.5|1.8||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow up, effect of CT video among those who completed the SUM.|||1.80|-2.50|0.75
74064391|NCT03125915|147681031|SUPERIORITY||Beta|-2.3||||0.14|TWO_SIDED|95.0|-5.37|0.77||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-Month follow up, effect of CT video among those who did not complete SUM.|||0.77|-5.37|0.14
74064392|NCT03125915|147681031|SUPERIORITY||Beta|-2.79||||0.013|TWO_SIDED|95.0|-5.0|-0.58||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who viewed the CT video.|||-0.58|-5.00|0.013
74064393|NCT03125915|147681031|SUPERIORITY||Beta|-2.09||||0.1|TWO_SIDED|95.0|-4.56|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who did not view CT video|||0.38|-4.56|0.10
74064394|NCT03125915|147681031|SUPERIORITY||Beta|0.4||||0.78|TWO_SIDED|95.0|-2.35|3.16||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT Video among those who completed the SUM|A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.||3.16|-2.35|0.78
74064395|NCT03125915|147681031|SUPERIORITY||Beta|-0.3||||0.75|TWO_SIDED|95.0|-2.12|1.53||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.|||1.53|-2.12|0.75
74064396|NCT03125915|147681031|SUPERIORITY||Beta|-3.93||||0.014|TWO_SIDED|95.0|-7.06|-0.81||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed the CT video.|||-0.81|-7.06|0.014
74064397|NCT03125915|147681031|SUPERIORITY||Beta|-0.57||||0.67|TWO_SIDED|95.0|-3.16|2.03||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of SUM among those who did not view CT video.|||2.03|-3.16|0.67
74064398|NCT03125915|147681031|SUPERIORITY||Beta|-0.24||||0.83|TWO_SIDED|95.0|-2.39|1.91||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of CT video among those who completed the SUM.|||1.91|-2.39|0.83
74064399|NCT03125915|147681031|SUPERIORITY||Beta|3.13||||0.05|TWO_SIDED|95.0|-0.004|6.25||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of CT video among those who did not complete SUM.|||6.25|-0.004|0.05
74064400|NCT03125915|147681032|SUPERIORITY||Beta|0.05||||0.9|TWO_SIDED|95.0|-2.3|2.41||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent intercept factor among those who did not view CT videos|||2.41|-2.30|0.90
74064401|NCT03125915|147681032|SUPERIORITY||Beta|0.26||||0.78|TWO_SIDED|95.0|-2.23|2.75||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT video on the latent intercept factor among those who did not view SUM.|||2.75|-2.23|0.78
74064402|NCT03125915|147681032|SUPERIORITY||Beta|-1.18||||0.53|TWO_SIDED|95.0|-4.86|2.51||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT video on the latent intercept.|||2.51|-4.86|0.53
74064403|NCT03125915|147681032|SUPERIORITY||Beta|1.83||||0.14|TWO_SIDED|95.0|-0.62|4.29||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent slope factor among those who did not view CT Videos.|||4.29|-0.62|0.14
74064404|NCT03125915|147681032|SUPERIORITY||Beta|0.35||||0.76|TWO_SIDED|95.0|-2.02|2.72||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT Video on latent slope factor among those who did not complete the SUM.|||2.72|-2.02|0.76
74064405|NCT03125915|147681032|SUPERIORITY||Beta|-1.28||||0.45|TWO_SIDED|95.0|-4.62|2.06||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT videos in the prediction of the latent slope factor.|||2.06|-4.62|0.45
74064406|NCT03125915|147681033|SUPERIORITY||Beta|-0.75||||0.02|TWO_SIDED|95.0|-1.39|-0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who viewed CT videos.|||-0.11|-1.39|0.02
74064407|NCT03125915|147681033|SUPERIORITY||Beta|-0.49||||0.1|TWO_SIDED|95.0|-1.07|0.09||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did not view CT videos.|||0.09|-1.07|0.10
74064408|NCT03125915|147681033|SUPERIORITY||Beta|-0.15||||0.63|TWO_SIDED|95.0|-0.77|0.47||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who completed SUM.|||0.47|-0.77|0.63
74064409|NCT03125915|147681033|SUPERIORITY||Beta|-0.41||||0.19|TWO_SIDED|95.0|-1.01|0.2||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who did not complete SUM.|||0.20|-1.01|0.19
74064410|NCT03125915|147681033|SUPERIORITY||Beta|-0.64||||0.01|TWO_SIDED|95.0|-1.13|-0.15||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of SUM among those who completed the CT video.|||-0.15|-1.13|0.01
74064411|NCT03125915|147681033|SUPERIORITY||Beta|-0.49||||0.12|TWO_SIDED|95.0|-1.11|0.12||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of SUM among those who did not complete CT video.|||0.12|-1.11|0.12
74064412|NCT03125915|147681033|SUPERIORITY||Beta|-0.34||||0.23|TWO_SIDED|95.0|-0.89|0.21||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of CT video among those who completed SUM.|||0.21|-0.89|0.23
74064413|NCT03125915|147681033|SUPERIORITY||Beta|-0.19||||0.51|TWO_SIDED|95.0|-0.76|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.|||0.38|-0.76|0.51
74064414|NCT03125915|147681033|SUPERIORITY||Beta|-0.79||||0.003|TWO_SIDED|95.0|-1.32|-0.27||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed CT videos.|||-0.27|-1.32|0.003
74064415|NCT03125915|147681033|SUPERIORITY||Beta|-0.25||||0.49|TWO_SIDED|95.0|-0.96|0.46||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of SUM among those who did not view the CT video.|||0.46|-0.96|0.49
74064416|NCT03125915|147681033|SUPERIORITY||Beta|-0.53||||0.1|TWO_SIDED|95.0|-1.16|0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who completed SUM.|||0.11|-1.16|0.10
74064417|NCT03125915|147681033|SUPERIORITY||Beta|-0.02||||0.96|TWO_SIDED|95.0|-0.6|0.64||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who did not complete SUM.|||0.64|-0.60|0.96
74064418|NCT04542330|147681034|SUPERIORITY||||||<|0.05|||||||Andersen-Gill Cox|||Acute infection was analysed as recurrent events using an Andersen-Gill Cox proportional hazards regression model with time since inclusion as underlying time scale. The analysis was done for the composite outcome and for all subcomponents separately, presenting Hazard Ratios (HR) with 95% Confidence Intervals (CI) for each. For all recurrent outcomes, a wash-out period of 14 days was used to define new events.||||< 0.05
74064419|NCT04542330|147681035|SUPERIORITY||||||<|0.05|||||||Regression, Cox|||Verified SARS-CoV-2 infection (first event) and all-cause hospitalisation (first event) was analysed using standard Cox proportional hazards models, but otherwise as described for primary outcome.||||< 0.05
73882871|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-19.22|STANDARD_ERROR_OF_MEAN|8.504|||TWO_SIDED|90.0|-33.45|-4.99||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-4.99|-33.45|
74064420|NCT04542330|147681036|SUPERIORITY||||||<|0.05|||||||Andersen-Gill Cox|||The secondary outcome, self-reported respiratory symptoms, was analysed the same way as the primary outcome (recurrent events).||||< 0.05
74064421|NCT04542330|147681037|SUPERIORITY||||||<|0.05|||||||Regression, Cox|||Verified SARS-CoV-2 infection (first event) and all-cause hospitalisation (first event) was analysed using standard Cox proportional hazards models, but otherwise as described for the primary outcome.||||< 0.05
74064422|NCT01164137|147681044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.87|TWO_SIDED|95.0|-0.98|0.84|||t-test, 2 sided|||||.84|-.98|.87
74064423|NCT01164137|147681045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.32|TWO_SIDED|95.0|-0.62|1.88|||t-test, 2 sided|||||1.88|-.62|.32
74064424|NCT01164137|147681046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21||||0.18|TWO_SIDED|95.0|-0.57|3.01|||t-test, 2 sided|||||3.01|-.57|.18
74064425|NCT01164137|147681047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.11|TWO_SIDED|95.0|-0.39|3.81|||t-test, 2 sided|||||3.81|-.39|.11
74064426|NCT01164137|147681048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.85||||0.13|TWO_SIDED|95.0|-0.56|4.27|||t-test, 2 sided|||||4.27|-.56|.13
74064427|NCT04523831|147681049|SUPERIORITY||Cox Proportional Hazard|0.53|||<|0.03|TWO_SIDED|95.0|0.3|0.96|||Regression, Linear|||||0.96|0.30|<0.03
74064428|NCT04523831|147681050|SUPERIORITY||Cox Proportional Hazard|0.51|||<|0.004|TWO_SIDED|95.0|0.32|0.8|||Regression, Logistic|||||0.80|0.32|<0.004
74064429|NCT04523831|147681051|SUPERIORITY||Cox Proportional Hazard|0.45|||<|0.013|TWO_SIDED|95.0|0.23|0.85|||Regression, Logistic|||||0.85|0.23|<0.013
74064430|NCT04523831|147681052|SUPERIORITY||Cox Proportional Hazard|0.58|||<|0.001|TWO_SIDED|95.0|0.44|0.81|||Regression, Logistic|||||0.81|0.44|<0.001
74064431|NCT00430638|147681059|SUPERIORITY_OR_OTHER||||||<|0.0001||||||No multiplicity adjustments|ANCOVA|The ANCOVA model included randomized treatment and baseline cuff blood pressure stage as factors and study baseline systolic BP value as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
74064432|NCT00430638|147681060|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|The ANCOVA Model included randomized treatment and baseline cuff BP stage as factors and study baseline diastolic BP as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
74064433|NCT00430638|147681061|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (male systolic blood pressure (SBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
74064434|NCT00430638|147681061|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Males - diastolic blood pressure (DBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
74064435|NCT00430638|147681062|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
74064436|NCT00430638|147681062|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
74064437|NCT00430638|147681063|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - less than 65 years of age): For the efficacy population \< 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
74064438|NCT00430638|147681063|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - less than 65 years of age): For the efficacy population \< 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
74064439|NCT00430638|147681064|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - \> or equal to 65 years old): For the efficacy population \> or = to 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||0.0125
74064440|NCT00430638|147681064|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) \> or equal to 65): For the efficacy population \> or = to 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||0.0006
74064441|NCT00430638|147681065|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
74064442|NCT00430638|147681065|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
74064443|NCT00430638|147681066|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
74064444|NCT00430638|147681066|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Diastolic blood pressure (DBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
74064445|NCT00430638|147681067|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
74064446|NCT00430638|147681067|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
74064447|NCT00430638|147681068|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
74064448|NCT00430638|147681068|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
74064449|NCT05166421|147681090|OTHER||Geometric mean ratio|0.938|||||TWO_SIDED|90.0|0.8458|1.0403||||||Statistical Comparison of AUCinf of AZD7442||1.0403|0.8458|
74064450|NCT05166421|147681090|OTHER||Geometric mean ratio|0.9968|||||TWO_SIDED|90.0|0.898|1.1066||||||Statistical Comparison of AUCinf of AZD7442||1.1066|0.8980|
74064451|NCT05166421|147681090|OTHER||Geometric mean ratio|1.0627|||||TWO_SIDED|90.0|0.9579|1.179||||||Statistical Comparison of AUCinf of AZD7442||1.1790|0.9579|
74064452|NCT05166421|147681090|OTHER||Geometric mean ratio|0.8992|||||TWO_SIDED|90.0|0.8107|0.9974||||||Statistical Comparison of AUCinf of AZD8895||0.9974|0.8107|
74064453|NCT05166421|147681090|OTHER||Geometric mean ratio|0.9826|||||TWO_SIDED|90.0|0.8854|1.0905||||||Statistical Comparison of AUCinf of AZD8895||1.0905|0.8854|
74064454|NCT05166421|147681090|OTHER||Geometric mean ratio|1.0928|||||TWO_SIDED|90.0|0.9853|1.212||||||Statistical Comparison of AUCinf of AZD8895||1.2120|0.9853|
74064455|NCT05166421|147681090|OTHER||Geometric mean ratio|1.0039|||||TWO_SIDED|90.0|0.9029|1.1161||||||Statistical Comparison of AUCinf of AZD1061||1.1161|0.9029|
74064456|NCT05166421|147681090|OTHER||Geometric mean ratio|1.0336|||||TWO_SIDED|90.0|0.9288|1.1503||||||Statistical Comparison of AUCinf of AZD1061||1.1503|0.9288|
74064457|NCT05166421|147681090|OTHER||Geometric mean ratio|1.0296|||||TWO_SIDED|90.0|0.9258|1.1451||||||Statistical Comparison of AUCinf of AZD1061||1.1451|0.9258|
74064458|NCT05166421|147681091|OTHER||Geometric mean ratio|0.9418|||||TWO_SIDED|90.0|0.8512|1.0421||||||Statistical Comparison of AUClast of AZD7442||1.0421|0.8512|
74064459|NCT05166421|147681091|OTHER||Geometric mean ratio|0.9973|||||TWO_SIDED|90.0|0.9004|1.1046||||||Statistical Comparison of AUClast of AZD7442||1.1046|0.9004|
74064460|NCT05166421|147681091|OTHER||Geometric mean ratio|1.0589|||||TWO_SIDED|90.0|0.9559|1.173||||||Statistical Comparison of AUClast of AZD7442||1.1730|0.9559|
74064461|NCT05166421|147681091|OTHER||Geometric mean ratio|0.8812|||||TWO_SIDED|90.0|0.7933|0.9788||||||Statistical Comparison of AUClast of AZD8895||0.9788|0.7933|
74064462|NCT05166421|147681091|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.8633|1.0674||||||Statistical Comparison of AUClast of AZD8895||1.0674|0.8633|
74064463|NCT05166421|147681091|OTHER||Geometric mean ratio|1.0894|||||TWO_SIDED|90.0|0.9796|1.2116||||||Statistical Comparison of AUClast of AZD8895||1.2116|0.9796|
74064464|NCT05166421|147681091|OTHER||Geometric mean ratio|1.0065|||||TWO_SIDED|90.0|0.9061|1.118||||||Statistical Comparison of AUClast of AZD1061||1.1180|0.9061|
74064465|NCT05166421|147681091|OTHER||Geometric mean ratio|1.0293|||||TWO_SIDED|90.0|0.9257|1.1446||||||Statistical Comparison of AUClast of AZD1061||1.1446|0.9257|
74064466|NCT05166421|147681091|OTHER||Geometric mean ratio|1.0227|||||TWO_SIDED|90.0|0.9196|1.1373||||||Statistical Comparison of AUClast of AZD1061||1.1373|0.9196|
74064467|NCT05166421|147681092|OTHER||Geometric mean ratio|1.0308|||||TWO_SIDED|90.0|0.9451|1.1243||||||Statistical Comparison of Cmax of AZD7442||1.1243|0.9451|
74064468|NCT05166421|147681092|OTHER||Geometric mean ratio|0.993|||||TWO_SIDED|90.0|0.9112|1.0822||||||Statistical Comparison of Cmax of AZD7442||1.0822|0.9112|
74064469|NCT05166421|147681092|OTHER||Geometric mean ratio|0.9634|||||TWO_SIDED|90.0|0.8833|1.0507||||||Statistical Comparison of Cmax of AZD7442||1.0507|0.8833|
74064470|NCT05166421|147681092|OTHER||Geometric mean ratio|0.9701|||||TWO_SIDED|90.0|0.8894|1.0582||||||Statistical Comparison of Cmax of AZD8895||1.0582|0.8894|
74064471|NCT05166421|147681092|OTHER||Geometric mean ratio|0.9629|||||TWO_SIDED|90.0|0.8835|1.0494||||||Statistical Comparison of Cmax of AZD8895||1.0494|0.8835|
74064472|NCT05166421|147681092|OTHER||Geometric mean ratio|0.9926|||||TWO_SIDED|90.0|0.91|1.0826||||||Statistical Comparison of Cmax of AZD8895||1.0826|0.9100|
74064473|NCT05166421|147681092|OTHER||Geometric mean ratio|1.0976|||||TWO_SIDED|90.0|0.9992|1.2057||||||Statistical Comparison of Cmax of AZD1061||1.2057|0.9992|
74064474|NCT05166421|147681092|OTHER||Geometric mean ratio|1.0195|||||TWO_SIDED|90.0|0.929|1.119||||||Statistical Comparison of Cmax of AZD1061||1.1190|0.9290|
74064475|NCT05166421|147681092|OTHER||Geometric mean ratio|0.9289|||||TWO_SIDED|90.0|0.8457|1.0203||||||Statistical Comparison of Cmax of AZD1061||1.0203|0.8457|
74064476|NCT02580318|147681117|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (poor effort)|t-test, 2 sided|||this p value is calculated for poor effort||||<0.0001
74064477|NCT02580318|147681117|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (hyperventilation - immediate)|t-test, 2 sided|||p value calculated for hyperventilation (immediate)||||<0.0001
74064478|NCT02580318|147681117|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 5 minutes)||||<0.0001
73882872|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|10.387|||TWO_SIDED|90.0|-21.71|13.11||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||13.11|-21.71|
74064479|NCT02580318|147681117|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (10 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 10 minutes)||||<0.0001
74064480|NCT02580318|147681117|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (immediately after drinking water)|t-test, 2 sided|||p value calculated for drinking water (immediate)||||<0.0001
74064481|NCT02580318|147681117|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after drinking water)|t-test, 2 sided|||p value calculated for drinking water (5 minutes)||||<0.0001
74064482|NCT01735877|147681121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.52||0.77|||||||t-test, 2 sided|||At Baseline||||0.77
74064483|NCT01735877|147681121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.12|||<|0.0001|TWO_SIDED|95.0|11.02|17.25|||ANCOVA|||Mean Change from baseline to 1 month||17.25|11.02|<0.0001
74064484|NCT01735877|147681121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.56|||<|0.0001|TWO_SIDED|95.0|18.65|26.48|||ANCOVA|||Baseline to 3 month||26.48|18.65|<0.0001
74064485|NCT01735877|147681121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.28|||<|0.0001|TWO_SIDED|95.0|18.94|27.62|||ANCOVA|||Baseline to 6 month||27.62|18.94|<0.0001
74064486|NCT01735877|147681122|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At Baseline||||0.99
74064487|NCT01735877|147681122|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At 1 month||||0.99
74064488|NCT01735877|147681122|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||At 3 months||||0.03
74064489|NCT01735877|147681122|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||At 6 months||||0.004
74064490|NCT01735877|147681123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|3.25||0.64|||||||t-test, 2 sided|||At Baseline||||0.64
74064491|NCT01735877|147681123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.92||||0.002|TWO_SIDED|95.0|2.24|9.6|||ANCOVA|||Mean change from baseline to 1 month||9.60|2.24|0.002
74064492|NCT01735877|147681123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.71||||0.005|TWO_SIDED|95.0|2.8|14.63|||ANCOVA|||Mean change from baseline to 3 month||14.63|2.80|0.005
74064493|NCT01735877|147681123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.63||||0.006|TWO_SIDED|95.0|2.67|14.6|||ANCOVA|||Mean change from baseline to 6 month||14.60|2.67|0.006
74064494|NCT01735877|147681124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.24||0.99|||||||t-test, 2 sided|||Baseline||||0.99
74064495|NCT01735877|147681124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|||<|0.0001|TWO_SIDED|95.0|2.93|4.42|||ANCOVA|||Mean change from baseline to 1 month||4.42|2.93|<0.0001
74064496|NCT01735877|147681124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||<|0.0001|TWO_SIDED|95.0|2.61|4.21|||ANCOVA|||Mean change from baseline to 3 month||4.21|2.61|<0.0001
74064497|NCT01735877|147681124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21|||<|0.0001|TWO_SIDED|95.0|2.4|4.02|||ANCOVA|||Mean change from baseline to 6 month||4.02|2.40|<0.0001
74064498|NCT01735877|147681125|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At Baseline||||0.99
74064499|NCT01735877|147681125|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At month 1||||0.99
74064500|NCT01735877|147681125|SUPERIORITY_OR_OTHER|||||||0.04|||||||Chi-squared|||At month 3||||0.04
74064501|NCT01735877|147681125|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||At month 6||||0.01
74064502|NCT00782275|147681184|SUPERIORITY|||||||0.081|||||||exact binomial test|||The regimen was evaluated against an historical control with null and alternative 4-month PFS rates of 50% and 70%, respectively. With the final sample size of 40 eligible patients and using the same operating characteristics (alpha and beta 10%), the decision rule changes such that if 25 or more patients of 40 are alive and progression-free at 4 months then this regimen is considered promising.||||0.081
74064503|NCT00331773|147681192|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This trial was designed to establish with 90% power and a two-sided significance level of 0.05 that Arm 2 (Hypofractionated 3D-CRT) results in a 5-year DFS that is not lower than Arm 1 by more than 7.65% (hazard ratio \[HR\] , 1.52). Patients analyzed according to assignment, with time-to event duration originating at random assignment. DFS distributions calculated using the Kaplan-Meier method. Treatment efficacy for DFS was tested by comparing cause-specific hazards with the log-rank statistic.|Hazard Ratio (HR)|0.85|||<|0.001|TWO_SIDED|95.0|0.64|1.14|||Log Rank||Reference arm = Conventional 3D-CRT|||1.14|0.64|<0.001
73882873|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-18.04|STANDARD_ERROR_OF_MEAN|10.273|||TWO_SIDED|90.0|-35.25|-0.82||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.82|-35.25|
73882874|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-27.07|STANDARD_ERROR_OF_MEAN|10.646|||TWO_SIDED|90.0|-44.9|-9.23||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-9.23|-44.90|
73882875|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-10.07|STANDARD_ERROR_OF_MEAN|11.013|||TWO_SIDED|90.0|-28.53|8.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||8.39|-28.53|
73882876|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-29.23|STANDARD_ERROR_OF_MEAN|10.793|||TWO_SIDED|90.0|-47.33|-11.13||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-11.13|-47.33|
74064504|NCT00331773|147681195|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Patients who died without biochemical failure were considered as competing risk at the time of death. Patients alive without biochemical failure at last follow-up were censored at that date. Estimates were calculated using cumulative risk and non-inferiority was assessed against a HR of 1.67. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.51|1.17|||Log Rank||Reference arm = Conventional 3D-CRT|||1.17|0.51|< 0.001
74064505|NCT00331773|147681196|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed against a HR of 1.54, translated from a 5% difference in overall survival with 90% overall survival in the Conventional 3D-CRT arm. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.95||||0.008|TWO_SIDED|95.0|0.64|1.41|||Log Rank||Reference arm = Conventional 3D-CRT|||1.41|0.64|0.008
74064506|NCT00331773|147681197|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.85|TWO_SIDED|95.0|0.73|1.46||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% confidence intervals (CIs) were computed.||1.46|0.73|0.85
74064507|NCT00331773|147681197|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.31||||0.72|TWO_SIDED|95.0|0.29|5.81||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||5.81|0.29|0.72
73882877|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-49.99|STANDARD_ERROR_OF_MEAN|11.299|||TWO_SIDED|90.0|-68.92|-31.05||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-31.05|-68.92|
73882878|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-24.25|STANDARD_ERROR_OF_MEAN|11.33|||TWO_SIDED|90.0|-43.26|-5.24||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.24|-43.26|
73882879|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-27.47|STANDARD_ERROR_OF_MEAN|11.155|||TWO_SIDED|90.0|-46.18|-8.75||||||PF-04965842 400 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-8.75|-46.18|
73882880|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-52.63|STANDARD_ERROR_OF_MEAN|11.697|||TWO_SIDED|90.0|-72.24|-33.02||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-33.02|-72.24|
73882881|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-17.98|STANDARD_ERROR_OF_MEAN|10.605|||TWO_SIDED|90.0|-35.8|-0.15|||LANCOVA|||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.15|-35.80|
74064508|NCT00331773|147681197|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.82|1.21||2-sided|Regression, Logistic||Reference Arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||1.21|0.82|0.95
73882882|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-14.78|STANDARD_ERROR_OF_MEAN|10.513|||TWO_SIDED|90.0|-32.44|2.88||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.88|-32.44|
73882883|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-47.94|STANDARD_ERROR_OF_MEAN|11.125|||TWO_SIDED|90.0|-66.61|-29.27||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-29.27|-66.61|
73882884|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean|-21.75|STANDARD_ERROR_OF_MEAN|11.459|||TWO_SIDED|90.0|-41.0|-2.49||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.49|-41.00|
74064509|NCT00331773|147681197|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.36||||0.39|TWO_SIDED|95.0|0.67|2.74||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.74|0.67|0.39
74064510|NCT00331773|147681197|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.59||||0.005|TWO_SIDED|95.0|1.22|2.06||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.06|1.22|0.005
74064511|NCT00331773|147681197|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.55||||0.19|TWO_SIDED|95.0|0.8|2.99||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.99|0.80|0.19
74064512|NCT00331773|147681197|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.31||||0.009|TWO_SIDED|95.0|1.07|1.61||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||1.61|1.07|0.009
74064513|NCT00331773|147681197|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.56||||0.22|TWO_SIDED|95.0|0.76|3.18||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||3.18|0.76|0.22
74064514|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 6 months||||0.72
74064515|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 6 months||||0.056
74064516|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 6 months||||0.99
74064517|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 6 months||||0.49
74064518|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 12 months||||0.0037
74064519|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 12 months||||0.062
74064520|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 12 months||||0.94
74064521|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 12 months||||0.93
74064522|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 24 months||||0.12
74064523|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 24 months||||0.81
74064524|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 24 months||||0.69
74064525|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 24 months||||0.68
74064526|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 60 months||||0.071
74064527|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 60 months||||0.047
74064528|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 60 months||||0.4
74064529|NCT00331773|147681198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 60 months||||0.91
74064530|NCT00331773|147681200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 6 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.55
74064531|NCT00331773|147681200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 12 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.29
74064532|NCT00331773|147681200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 24 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.23
74064533|NCT00331773|147681200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 60 months (5 years) was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.028
74064534|NCT00331773|147681201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level = 0.05||Baseline VAS score||||0.037
74064535|NCT00331773|147681201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||Baseline index score||||0.12
74064536|NCT00331773|147681201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month VAS score||||0.70
74064537|NCT00331773|147681201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month index score||||0.20
74064538|NCT00331773|147681201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month VAS score||||0.31
74064539|NCT00331773|147681201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month index score||||0.19
74064540|NCT00331773|147681201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month VAS score||||0.86
74064541|NCT00331773|147681201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month index score||||0.45
74064542|NCT00331773|147681201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month VAS score||||0.39
74064543|NCT00331773|147681201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month index score||||0.56
74064544|NCT00289731|147681206|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.66|||||TWO_SIDED|95.0|-5.34|1.48||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HAV seropositivity rates, at Month 7.||1.48|-5.34|
74064545|NCT00289731|147681206|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.63|||||TWO_SIDED|95.0|-5.31|1.6||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HAV seropositivity rates, at Month 7.||1.60|-5.31|
74064546|NCT00289731|147681207|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seroprotection rates for anti-HBs antibody, being - 10%.|Difference in seroprotection rate|12.04|||||TWO_SIDED|95.0|4.97|19.35||||||Difference in seroprotection rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HBs seroprotection rates, at Month 7.||19.35|4.97|
74064547|NCT00289731|147681207|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seroprotection rates for anti-HBs antibody, being - 15%.|Difference in seroprotection rates|20.69|||||TWO_SIDED|95.0|12.92|28.62||||||Difference in seropositivity rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HBs seroprotection rates, at Month 7.||28.62|12.92|
74064548|NCT00747747|147681240|SUPERIORITY_OR_OTHER||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypothesis: no difference among groups.||||<0.05
74064549|NCT00747747|147681245|SUPERIORITY_OR_OTHER||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypotheis: no difference among the groups.||||<0.05
74064550|NCT01872689|147681261|SUPERIORITY||Median Difference (Final Values)|0.98111|STANDARD_ERROR_OF_MEAN|1.31064||0.4555|TWO_SIDED|95.0|-1.61|3.57|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||3.57|-1.61|0.4555
74064551|NCT01872689|147681261|SUPERIORITY||Mean Difference (Final Values)|0.49998|STANDARD_ERROR_OF_MEAN|0.84946||0.5566|TWO_SIDED|95.0|-1.17|2.17|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.17|-1.17|0.5566
74064552|NCT01872689|147681262|SUPERIORITY||Median Difference (Final Values)|21.93023|STANDARD_ERROR_OF_MEAN|21.62248||0.3129|TWO_SIDED|95.0|-20.97|64.83|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||64.83|-20.97|0.3129
74064553|NCT01872689|147681262|SUPERIORITY||Mean Difference (Final Values)|-21.4127|STANDARD_ERROR_OF_MEAN|16.8016||0.2036|TWO_SIDED|95.0|-54.5|11.67|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||11.67|-54.50|0.2036
74064554|NCT01872689|147681264|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.4299|TWO_SIDED|95.0|0.44|1.41|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.41|0.44|0.4299
73882885|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-17.75|STANDARD_ERROR_OF_MEAN|11.416|||TWO_SIDED|90.0|-36.92|1.42||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.42|-36.92|
73882886|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-35.88|STANDARD_ERROR_OF_MEAN|11.893|||TWO_SIDED|90.0|-55.85|-15.9||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-15.90|-55.85|
74064555|NCT01872689|147681264|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3751|TWO_SIDED|95.0|0.56|1.24|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.24|0.56|0.3751
73882887|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-10.75|STANDARD_ERROR_OF_MEAN|12.985|||TWO_SIDED|90.0|-32.57|11.07||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||11.07|-32.57|
73882888|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-13.03|STANDARD_ERROR_OF_MEAN|12.902|||TWO_SIDED|90.0|-34.71|8.64||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||8.64|-34.71|
74064556|NCT01872689|147681265|SUPERIORITY||Median Difference (Final Values)|0.54171|STANDARD_ERROR_OF_MEAN|1.05201||0.6075|TWO_SIDED|95.0|-1.54|2.62|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.62|-1.54|0.6075
74064557|NCT01872689|147681265|SUPERIORITY||Mean Difference (Final Values)|0.18203|STANDARD_ERROR_OF_MEAN|0.65206||0.7803|TWO_SIDED|95.0|-1.1|1.47|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||1.47|-1.10|0.7803
74064558|NCT01872689|147681267|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0972|TWO_SIDED|95.0|0.39|1.09|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.09|0.39|0.0972
74064559|NCT01872689|147681267|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9344|TWO_SIDED|95.0|0.72|1.42|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.42|0.72|0.9344
74064560|NCT01872689|147681268|SUPERIORITY||Median Difference (Final Values)|28.12302|STANDARD_ERROR_OF_MEAN|49.47253||0.5707|TWO_SIDED|95.0|-69.8|126.04|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||126.04|-69.80|0.5707
74064561|NCT01872689|147681268|SUPERIORITY||Mean Difference (Final Values)|21.72972|STANDARD_ERROR_OF_MEAN|31.68767||0.4934|TWO_SIDED|95.0|-40.65|84.11|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||84.11|-40.65|0.4934
74064562|NCT01872689|147681269|SUPERIORITY||Median Difference (Final Values)|-2.10204|STANDARD_ERROR_OF_MEAN|2.41325||0.3854|TWO_SIDED|95.0|-6.88|2.68|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.68|-6.88|0.3854
74064563|NCT01872689|147681269|SUPERIORITY||Mean Difference (Final Values)|-0.16313|STANDARD_ERROR_OF_MEAN|1.37698||0.9057|TWO_SIDED|95.0|-2.87|2.55|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.55|-2.87|0.9057
74064564|NCT01872689|147681271|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4433|TWO_SIDED|95.0|0.54|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.31|0.54|0.4433
74064565|NCT01872689|147681273|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.9366|TWO_SIDED|95.0|0.21|5.3|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||5.30|0.21|0.9366
74064566|NCT01872689|147681273|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.1346|TWO_SIDED|95.0|0.16|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.31|0.16|0.1346
74064567|NCT01872689|147681275|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.6815|TWO_SIDED|95.0|0.52|1.54|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.54|0.52|0.6815
74064568|NCT01872689|147681277|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.5685|TWO_SIDED|95.0|0.23|2.26|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||2.26|0.23|0.5685
74064569|NCT01872689|147681277|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.1976|TWO_SIDED|95.0|0.37|1.23|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.23|0.37|0.1976
74064570|NCT02143947|147681310|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Mixed Models Analysis|||||||> .10
74064571|NCT02143947|147681311|SUPERIORITY_OR_OTHER||||||=|0.036|TWO_SIDED||||||Mixed Models Analysis|||||||= .036
73882889|NCT02201524|147299771|SUPERIORITY_OR_OTHER||LS mean difference|-34.46|STANDARD_ERROR_OF_MEAN|13.69|||TWO_SIDED|90.0|-57.44|-11.48||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-11.48|-57.44|
74064572|NCT02143947|147681312|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Mixed Models Analysis|||||||> .10
74064573|NCT02143947|147681313|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< .05
74064574|NCT01244815|147681314|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-3.2||||0.008|TWO_SIDED|95.0|-5.6|-0.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.8|-5.6|0.008
74064575|NCT01244815|147681314|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.3|||<|0.001|TWO_SIDED|95.0|-7.7|-2.9||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-2.9|-7.7|<0.001
74064576|NCT01244815|147681314|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.2|||<|0.001|TWO_SIDED|95.0|-8.6|-3.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-3.8|-8.6|<0.001
74064577|NCT01244815|147681314|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.92|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 1 (Placebo\<2.5 mg=5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 1. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
74064578|NCT01244815|147681314|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.87|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 2 (Placebo=2.5 mg\<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 2. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
74064579|NCT01244815|147681314|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-3.4||||0.0021||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 3 (Placebo=2.5 mg=5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 3. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||0.0021
74064580|NCT01244815|147681314|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.28|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 4 (Placebo\<2.5 mg\<5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 4. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
74064581|NCT01244815|147681314|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.64|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 5 (Placebo=2.5 mg\<5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 5. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
74064582|NCT01244815|147681314|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.07|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 6 (Placebo\<2.5 mg=5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 6. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
74064583|NCT01244815|147681314|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.49|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 7 (Placebo\<2.5 mg\<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 7. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
74064584|NCT01244815|147681315|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.3|-0.9|<0.001
74064585|NCT01244815|147681315|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.4|-0.9|<0.001
74064586|NCT01244815|147681315|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.4|-1.0|<0.001
73882890|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.626|||TWO_SIDED|90.0|-4.73|0.72||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.72|-4.73|
73882891|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.603|||TWO_SIDED|90.0|-4.99|0.38||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.38|-4.99|
73882892|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-3.65|STANDARD_ERROR_OF_MEAN|1.668|||TWO_SIDED|90.0|-6.45|-0.86||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.86|-6.45|
74064587|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.0||||0.018|TWO_SIDED|95.0|1.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||7.6|1.2|0.018
74064588|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.4||||0.008|TWO_SIDED|95.0|1.4|8.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||8.6|1.4|0.008
74064589|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1||||0.129|TWO_SIDED|95.0|0.8|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||5.6|0.8|0.129
73882893|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|2.032|||TWO_SIDED|90.0|-4.49|2.32||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.32|-4.49|
74064590|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9||||0.003|TWO_SIDED|95.0|1.4|5.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||5.9|1.4|0.003
73882894|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-3.86|STANDARD_ERROR_OF_MEAN|2.011|||TWO_SIDED|90.0|-7.23|-0.49||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.49|-7.23|
73882895|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-5.16|STANDARD_ERROR_OF_MEAN|2.084|||TWO_SIDED|90.0|-8.65|-1.67||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.67|-8.65|
74064591|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8||||0.005|TWO_SIDED|95.0|1.4|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||5.6|1.4|0.005
73882896|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-2.34|STANDARD_ERROR_OF_MEAN|2.224|||TWO_SIDED|90.0|-6.07|1.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.39|-6.07|
73882897|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-6.12|STANDARD_ERROR_OF_MEAN|2.177|||TWO_SIDED|90.0|-9.78|-2.47||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.47|-9.78|
74064592|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|7.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||7.3|1.8|<0.001
74064593|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2||||0.018|TWO_SIDED|95.0|1.1|4.1||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||4.1|1.1|0.018
73882898|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-9.39|STANDARD_ERROR_OF_MEAN|2.286|||TWO_SIDED|90.0|-13.22|-5.56||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.56|-13.22|
73882899|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-3.25|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|90.0|-6.71|0.21||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.21|-6.71|
73882900|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-2.98|STANDARD_ERROR_OF_MEAN|2.035|||TWO_SIDED|90.0|-6.4|0.45||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.45|-6.40|
73882901|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-8.59|STANDARD_ERROR_OF_MEAN|2.167|||TWO_SIDED|90.0|-12.24|-4.95||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-4.95|-12.24|
74064594|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|2.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||7.6|2.2|<0.001
73882902|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-3.98|STANDARD_ERROR_OF_MEAN|2.321|||TWO_SIDED|90.0|-7.89|-0.08||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.08|-7.89|
73882903|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-3.8|STANDARD_ERROR_OF_MEAN|2.304|||TWO_SIDED|90.0|-7.68|0.07||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.07|-7.68|
73882904|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-6.94|STANDARD_ERROR_OF_MEAN|2.412|||TWO_SIDED|90.0|-11.0|-2.89||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.89|-11.00|
74064595|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|2.2|7.6|||Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||7.6|2.2|<0.001
74064596|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.042|TWO_SIDED|95.0|1.0|3.4||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||3.4|1.0|0.042
74064597|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2|||<|0.001|TWO_SIDED|95.0|1.7|5.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||5.8|1.7|<0.001
74064598|NCT01244815|147681316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9|||<|0.001||95.0|1.6|5.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||5.3|1.6|<0.001
74064599|NCT01244815|147681317|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25||||0.014|TWO_SIDED|95.0|-0.45|-0.05|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.05|-0.45|0.014
74064600|NCT01244815|147681317|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.17||||0.107|TWO_SIDED|95.0|-0.37|0.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.04|-0.37|0.107
74064601|NCT01244815|147681317|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21||||0.039|TWO_SIDED|95.0|-0.42|-0.01|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.01|-0.42|0.039
74064602|NCT01244815|147681318|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.33||||0.006|TWO_SIDED|95.0|-0.56|-0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.10|-0.56|0.006
74064603|NCT01244815|147681318|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.35||||0.003|TWO_SIDED|95.0|-0.59|-0.12|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.12|-0.59|0.003
74064604|NCT01244815|147681318|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.44|||<|0.001|TWO_SIDED|95.0|-0.67|-0.21|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.21|-0.67|<0.001
74064605|NCT01244815|147681319|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.34||||0.011|TWO_SIDED|95.0|-0.61|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.08|-0.61|0.011
74064606|NCT01244815|147681319|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.63|||<|0.001|TWO_SIDED|95.0|-0.89|-0.36|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.36|-0.89|<0.001
74064607|NCT01244815|147681319|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.61|||<|0.001|TWO_SIDED|95.0|-0.88|-0.35|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.35|-0.88|<0.001
74064608|NCT01244815|147681320|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.61|||<|0.001|TWO_SIDED|95.0|-0.9|-0.32|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.32|-0.90|<0.001
74064609|NCT01244815|147681320|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.75|||<|0.001|TWO_SIDED|95.0|-1.04|-0.46|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.46|-1.04|<0.001
74064610|NCT01244815|147681320|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.74|||<|0.001|TWO_SIDED|95.0|-1.03|-0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.45|-1.03|<0.001
74064611|NCT01244815|147681321|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.07||||0.536|TWO_SIDED|95.0|-0.28|0.15|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.15|-0.28|0.536
74064612|NCT01244815|147681321|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.811|TWO_SIDED|95.0|-0.24|0.19|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.19|-0.24|0.811
74064613|NCT01244815|147681321|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.07||||0.556|TWO_SIDED|95.0|-0.15|0.28|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.28|-0.15|0.556
74064614|NCT01244815|147681322|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21||||0.053|TWO_SIDED|95.0|-0.42|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.00|-0.42|0.053
74064615|NCT01244815|147681322|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.18||||0.094|TWO_SIDED|95.0|-0.4|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.03|-0.40|0.094
74064616|NCT01244815|147681322|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.15||||0.178|TWO_SIDED|95.0|-0.36|0.07|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.07|-0.36|0.178
74064617|NCT01244815|147681323|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.506|TWO_SIDED|95.0|-0.33|0.16|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.16|-0.33|0.506
74064618|NCT01244815|147681323|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.19||||0.131|TWO_SIDED|95.0|-0.43|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.06|-0.43|0.131
73882905|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|2.607|||TWO_SIDED|90.0|-5.65|3.11||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||3.11|-5.65|
74064619|NCT01244815|147681323|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16||||0.211|TWO_SIDED|95.0|-0.4|0.09|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.09|-0.40|0.211
74064620|NCT01244815|147681324|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.23||||0.079|TWO_SIDED|95.0|-0.49|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.03|-0.49|0.079
74064621|NCT01244815|147681324|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.34||||0.01|TWO_SIDED|95.0|-0.6|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.08|-0.60|0.010
74064622|NCT01244815|147681324|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.2||||0.139|TWO_SIDED|95.0|-0.46|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.06|-0.46|0.139
74064623|NCT01244815|147681325|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.61||||0.004|TWO_SIDED|95.0|-4.38|-0.83|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.83|-4.38|0.004
74064624|NCT01244815|147681325|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.17||||0.017|TWO_SIDED|95.0|-3.95|-0.39|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.39|-3.95|0.017
74064625|NCT01244815|147681325|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.16||||0.017|TWO_SIDED|95.0|-3.93|-0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.38|-3.93|0.017
73882906|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-2.83|STANDARD_ERROR_OF_MEAN|2.586|||TWO_SIDED|90.0|-7.18|1.51||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.51|-7.18|
74064626|NCT01244815|147681326|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.79||||0.395|TWO_SIDED|95.0|-2.62|1.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||1.04|-2.62|0.395
74064627|NCT01244815|147681326|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.44||||0.009|TWO_SIDED|95.0|-4.26|-0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.63|-4.26|0.009
73882907|NCT02201524|147299772|SUPERIORITY_OR_OTHER||LS mean difference|-6.52|STANDARD_ERROR_OF_MEAN|2.758|||TWO_SIDED|90.0|-11.15|-1.89||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.89|-11.15|
73882908|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.5|||||TWO_SIDED|90.0|-21.5|19.6||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||19.6|-21.5|
73882909|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-5.9|40.3||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||40.3|-5.9|
73882910|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|14.3|||||TWO_SIDED|90.0|-9.3|38.0|||Difference in Percentage Analysed using|||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||38.0|-9.3|
74064628|NCT01244815|147681326|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.44||||0.121|TWO_SIDED|95.0|-3.27|0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.38|-3.27|0.121
74064629|NCT01244815|147681327|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.44||||0.135|TWO_SIDED|95.0|-3.33|0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.45|-3.33|0.135
74064630|NCT01244815|147681327|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.19||||0.023|TWO_SIDED|95.0|-4.08|-0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.30|-4.08|0.023
74064631|NCT01244815|147681327|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.28||||0.189|TWO_SIDED|95.0|-3.2|0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.63|-3.20|0.189
74064632|NCT01244815|147681328|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.29||||0.002|TWO_SIDED|95.0|1.56|7.02|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||7.02|1.56|0.002
74064633|NCT01244815|147681328|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|6.95|||<|0.001|TWO_SIDED|95.0|4.22|9.68|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||9.68|4.22|<0.001
74064634|NCT01244815|147681328|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.11|||<|0.001|TWO_SIDED|95.0|2.31|7.91|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||7.91|2.31|<0.001
74064635|NCT01244815|147681329|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.24||||0.05|TWO_SIDED|95.0|0.0|4.48|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||4.48|-0.00|0.050
74064636|NCT01244815|147681329|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.35||||0.239|TWO_SIDED|95.0|-0.9|3.59|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||3.59|-0.90|0.239
74064637|NCT01244815|147681329|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.78||||0.018|TWO_SIDED|95.0|0.48|5.08|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||5.08|0.48|0.018
74064638|NCT01244815|147681330|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.39||||0.001|TWO_SIDED|95.0|0.15|0.62|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.62|0.15|0.001
74064639|NCT01244815|147681330|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.18||||0.135|TWO_SIDED|95.0|-0.06|0.41|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.41|-0.06|0.135
74064640|NCT01244815|147681330|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.25||||0.044|TWO_SIDED|95.0|0.01|0.49|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.49|0.01|0.044
74064641|NCT03944707|147681405|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|0.0698||0.6643|TWO_SIDED|80.0|-0.06|0.119||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.119|-0.060|0.6643
74064642|NCT03944707|147681409|SUPERIORITY||Median Difference (Net)|-0.09|STANDARD_DEVIATION|0.21||0.6609|TWO_SIDED|80.0|-0.35|0.18||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.18|-0.35|0.6609
74064643|NCT03944707|147681410|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|7.13||0.5107|TWO_SIDED|80.0|-9.0|9.1||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in mean morning PEF||9.1|-9.0|0.5107
74064644|NCT03944707|147681410|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_DEVIATION|9.15||0.3611|TWO_SIDED|80.0|-15.2|8.1||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in mean evening PEF||8.1|-15.2|0.3611
74064645|NCT03944707|147681411|SUPERIORITY||Mean Difference (Net)|-0.133|STANDARD_DEVIATION|0.1588||0.8022|TWO_SIDED|80.0|-0.336|0.071||Probability LOU064 better than placebo|Bayesian model||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.071|-0.336|0.8022
74064646|NCT03944707|147681412|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.1573||0.6312|TWO_SIDED|80.0|-0.251|0.149||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in daytime asthma symptom score||0.149|-0.251|0.6312
74064647|NCT03944707|147681412|SUPERIORITY||Mean Difference (Net)|0.075|STANDARD_DEVIATION|0.0819||0.1752|TWO_SIDED|80.0|-0.028|0.18||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in nighttime asthma symptom score||0.180|-0.028|0.1752
74064648|NCT02444182|147681413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.21||0.015|TWO_SIDED||||||paired t-test|||Null hypothesis was no difference in Gingival index between probiotics and control groups||||0.015
74064649|NCT02444182|147681414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.09||0.909|TWO_SIDED||||||paired t-test|||Null hypothesis was no difference in plaque index between probiotics and control groups||||0.909
74064650|NCT04126733|147681417|EQUIVALENCE|H0: ORR ≤ 5% versus H1: ORR \>5% The hypothesis was tested by a one-sided exact binomial test, assuming a background response rate for the combination to be at most 5%.|Rate|7.1||||0.2721||95.0|2.4|15.9||The target response rate for the combination treatment was 17%. Using a one-sided exact binomial test at a type-I error of at most 2.5% at least 8 responders out of the 70 patients were needed to achieve significance.|Exact Binomial Test|||||15.9|2.4|0.2721
74064651|NCT02354976|147681461|OTHER||Geometric mean ratio for difference|0.92||||0.407|TWO_SIDED|95.0|0.76|1.12|||Mixed Models Analysis|||||1.12|0.76|0.407
74064652|NCT02354976|147681462|OTHER||Geometric mean ratio for difference|0.84||||0.077|TWO_SIDED|95.0|0.7|1.02|||Mixed Models Analysis|||||1.02|0.70|0.077
74064653|NCT00986154|147681463|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed to accumulate approximately 220 Overall primary efficacy events in the mITT (modified Intent to Treat) Analysis Set. Assuming equal efficacy (Hazard Ratio = 1.00), a total of 220 events gave a power of 85% to demonstrate that (LMW) heparin/edoxaban was non-inferior to the comparator, considering a relative non-inferiority margin of 1.5 (two sided α=0.05).|Hazard Ratio (HR)|0.89|||<|0.0001|TWO_SIDED|95.0|0.703|1.128|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|(LMW) heparin/edoxaban will be non-inferior to (LMW) heparin/warfarin in preventing recurrence of acute, symptomatic VTE following initial index event. (LMW) Heparin/edoxaban was considered non-inferior to the standard therapy (\[LMW\] heparin/warfarin) if the upper limit of the two-sided 95% confidence interval (CI) for the Hazard Ratio (\[LMW\] heparin/edoxaban to standard therapy) was less than 1.5. Events included in Overall study period if occurred on or after randomization date up to Day 365.||1.128|.703|<0.0001
74064654|NCT00986154|147681464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9933|TWO_SIDED|95.0|0.832|1.2|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose.|||1.200|.832|.9933
74064655|NCT00986154|147681465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.004|TWO_SIDED|95.0|0.705|0.936|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|"Safety Analysis set includes all randomized subjects who received at least one dose of study drug.~Null hypothesis (LMW) heparin/edoxaban will be comparable to (LMW) heparin/warfarin in preventing recurrence of major or clinically relevant non-major bleeding."||.936|.705|.0040
73882911|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|-14.3|||||TWO_SIDED|90.0|-38.0|9.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||9.3|-38.0|
73882912|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|1.6|||||TWO_SIDED|90.0|-25.4|29.1||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||29.1|-25.4|
74064656|NCT03726437|147681466|SUPERIORITY|Analyses were performed to determine whether RealConsent was superior to Stress and Mood Management in reducing incidence of sexual violence victimization.|Risk Ratio (RR)|0.48||||0.0002|TWO_SIDED|95.0|0.33|0.69|||Mixed Models Analysis|Models adjusted for fixed effects.||||.69|.33|.0002
74064657|NCT03726437|147681466|SUPERIORITY||Odds Ratio (OR)|0.77||||0.31|TWO_SIDED|95.0|0.47|1.28|||Mixed Models Analysis|Models adjusted for fixed effects.||||1.28|.47|.31
74064658|NCT03726437|147681467|SUPERIORITY||Adjusted OR|1.17||||0.03|TWO_SIDED|95.0|0.12|1.22|||Mixed Models Analysis|Model adjusted for fixed effects.||||1.22|0.12|.03
74064659|NCT03726437|147681468|SUPERIORITY||Adjusted OR|-0.5|||<|0.05|TWO_SIDED|95.0|-1.27|0.27|||Mixed Models Analysis|Model adjusted for fixed effects.||||0.27|-1.27|<.05
74064660|NCT03726437|147681469|SUPERIORITY||Incidence rate ratio|0.81||||0.02|TWO_SIDED|95.0|0.67|0.97|||Mixed Models Analysis|Model adjusted for fixed effects.||||.97|.67|.02
74064661|NCT03726437|147681470|SUPERIORITY||Incidence rate ratio|1.05||||0.43|TWO_SIDED|95.0|0.92|1.2|||Mixed Models Analysis|Model adjusted for fixed effects.||||1.20|.92|.43
74064662|NCT03726437|147681471|SUPERIORITY||Adjusted OR|1.72||||0.006|TWO_SIDED|95.0|1.17|2.55|||Mixed Models Analysis|Model adjusted for fixed effects.||||2.55|1.17|.006
74064663|NCT02328807|147681472|OTHER||Negative biopsy rate at 6 months after R|0.667|||||TWO_SIDED|95.0|0.223|0.957|||||Two-sided exact confidence interval was calculated using Clopper-Pearson method.|This trail is a single cohort study and no statistical hypothesis test for the primary outcome was planned.||0.957|0.223|
74064664|NCT00068445|147681475|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.56
74064665|NCT00068445|147681476|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
74064666|NCT00068445|147681477|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
74064667|NCT00068445|147681478|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
74064668|NCT00068445|147681479|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
74064669|NCT00068445|147681480|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
74064670|NCT00068445|147681481|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
74064671|NCT00068445|147681482|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
74064672|NCT00068445|147681483|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
74064673|NCT00068445|147681484|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
74064674|NCT03118765|147681511|OTHER|ANOVA|LS mean ratio (%)|29.4|||||TWO_SIDED|90.0|21.14|41.0|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||41.00|21.14|
73882913|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|20.2|||||TWO_SIDED|90.0|-10.2|48.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||48.3|-10.2|
74064675|NCT03118765|147681511|OTHER|ANOVA|LS mean ratio (%)|57.0|||||TWO_SIDED|90.0|41.37|78.46|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||78.46|41.37|
74064676|NCT03118765|147681511|OTHER|ANOVA|LS mean ratio (%)|155.8|||||TWO_SIDED|90.0|111.88|216.99|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||216.99|111.88|
74064677|NCT03118765|147681512|OTHER|ANOVA|LS mean ratio (%)|39.7|||||TWO_SIDED|90.0|29.79|52.87|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||52.87|29.79|
74064678|NCT03118765|147681512|OTHER|ANOVA|LS mean ratio (%)|85.2|||||TWO_SIDED|90.0|64.43|112.64|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||112.64|64.43|
74064679|NCT03118765|147681512|OTHER|ANOVA|LS mean ratio (%)|211.5|||||TWO_SIDED|90.0|158.8|281.8|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||281.80|158.80|
74064680|NCT03118765|147681513|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.228|TWO_SIDED|95.0|-0.04|0.17|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.17|-0.04|0.228
74064681|NCT03118765|147681513|SUPERIORITY||Mean Difference (Net)|0.02||||0.655|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.13|-0.08|0.655
74064682|NCT03118765|147681513|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.894|TWO_SIDED|95.0|-0.1|0.11|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.11|-0.10|0.894
74064683|NCT03118765|147681513|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.26|TWO_SIDED|95.0|-0.04|0.16|||MMRM|||SPIRIVA RESPIMAT 5 μg vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.16|-0.04|0.260
74064684|NCT03118765|147681514|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 10 μg was (Geo mean: 108200 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
74064685|NCT03118765|147681514|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 20 μg was (Geo mean: 263100 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
73882914|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|1.9|||||TWO_SIDED|90.0|-26.7|31.0||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||31.0|-26.7|
74064686|NCT03118765|147681514|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 40 μg was (Geo mean: 438300 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
74064687|NCT03118765|147681515|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 10 μg was (Geo mean: 293700 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
74064688|NCT03118765|147681515|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 20 μg was (Geo mean: 436500 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
74064689|NCT03118765|147681515|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 40 μg was (Geo mean: 1249000 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
74064690|NCT03118765|147681516|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 1.082% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
74064691|NCT03118765|147681516|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 1.316% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
74064692|NCT03118765|147681516|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 1.096% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
74064693|NCT03118765|147681517|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 2.937% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
74064694|NCT03118765|147681517|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 2.183% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
74064695|NCT03118765|147681517|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 3.123% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
74064696|NCT03118765|147681518|OTHER||||||||||||||||||For GSP304 10 μg, geometric mean Cmax of tiotropium was 2.191 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
74064697|NCT03118765|147681518|OTHER||||||||||||||||||For GSP304 20 μg, geometric mean Cmax of tiotropium was 4.796 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
74064698|NCT03118765|147681518|OTHER||||||||||||||||||For GSP304 40 μg, geometric mean Cmax of tiotropium was 10.2 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
74064699|NCT03118765|147681519|OTHER||||||||||||||||||For GSP304 10 μg, geometric mean AUC0-tau of tiotropium was 8.597 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
74064700|NCT03118765|147681519|OTHER||||||||||||||||||For GSP304 20 μg, geometric mean AUC0-tau of tiotropium was 18.00 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
74064701|NCT03118765|147681519|OTHER||||||||||||||||||For GSP304 40 μg, geometric mean AUC0-tau of tiotropium was 42.69 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
74064702|NCT03118765|147681522|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean CavSS was 0.9536 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
74064703|NCT03118765|147681522|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean CavSS was 1.998 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
74064704|NCT03118765|147681522|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean CavSS was 5.083 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
74064705|NCT03118765|147681523|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.617 for GSP304 10 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
74064706|NCT03118765|147681523|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.522 for GSP304 20 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
74064707|NCT03118765|147681523|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.926 for GSP304 40 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
74064708|NCT03118765|147681524|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.944 for GSP304 10 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
74064709|NCT03118765|147681524|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.808 for GSP304 20 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
74064710|NCT03118765|147681524|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 2.125 for GSP304 40 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
74064711|NCT03118765|147681525|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.004|TWO_SIDED|95.0|0.04|0.21|||Mixed Models Analysis|||||0.21|0.04|0.004
74064712|NCT03118765|147681525|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Mixed Models Analysis|||||0.26|0.08|<0.001
74064713|NCT03118765|147681525|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.007|TWO_SIDED|95.0|0.03|0.21|||Mixed Models Analysis|||||0.21|0.03|0.007
74064714|NCT03118765|147681525|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Mixed Models Analysis|||||0.26|0.08|<0.001
74064715|NCT03118765|147681526|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.001|TWO_SIDED|95.0|0.08|0.28|||Mixed Models Analysis|||||0.28|0.08|0.001
74064716|NCT03118765|147681526|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.005|TWO_SIDED|95.0|0.05|0.25|||Mixed Models Analysis|||||0.25|0.05|0.005
74064717|NCT03118765|147681526|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.032|TWO_SIDED|95.0|0.01|0.21|||Mixed Models Analysis|||||0.21|0.01|0.032
74064718|NCT03118765|147681526|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.001|TWO_SIDED|95.0|0.07|0.27|||Mixed Models Analysis|||||0.27|0.07|0.001
74064719|NCT03118765|147681527|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.166|TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|||||0.21|-0.04|0.166
74064720|NCT03118765|147681527|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.182|TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|||||0.21|-0.04|0.182
74064721|NCT03118765|147681527|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.401|TWO_SIDED|95.0|-0.07|0.17|||Mixed Models Analysis|||||0.17|-0.07|0.401
73882915|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|23.6|||||TWO_SIDED|90.0|-6.9|49.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||49.8|-6.9|
74064722|NCT03118765|147681527|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.574|TWO_SIDED|95.0|-0.09|0.16|||Mixed Models Analysis|||||0.16|-0.09|0.574
74064723|NCT03118765|147681528|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.493|TWO_SIDED|95.0|-0.1|0.21|||Mixed Models Analysis|||||0.21|-0.10|0.493
74064724|NCT03118765|147681528|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.864|TWO_SIDED|95.0|-0.17|0.14|||Mixed Models Analysis|||||0.14|-0.17|0.864
74064725|NCT03118765|147681528|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.978|TWO_SIDED|95.0|-0.16|0.15|||Mixed Models Analysis|||||0.15|-0.16|0.978
74064726|NCT03118765|147681528|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5|TWO_SIDED|95.0|-0.1|0.2|||Mixed Models Analysis|||||0.20|-0.10|0.500
74064727|NCT03118765|147681529|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.003|TWO_SIDED|95.0|0.04|0.2|||Mixed Models Analysis|||||0.20|0.04|0.003
74064728|NCT03118765|147681529|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.001|TWO_SIDED|95.0|0.06|0.22|||Mixed Models Analysis|||||0.22|0.06|0.001
74064729|NCT03118765|147681529|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.001|TWO_SIDED|95.0|0.06|0.21|||Mixed Models Analysis|||||0.21|0.06|0.001
73882916|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|67.8|||||TWO_SIDED|90.0|36.4|85.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||85.3|36.4|
74064730|NCT03118765|147681529|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.08|0.23|||Mixed Models Analysis|||||0.23|0.08|<0.001
73882917|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|7.6|67.1||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||67.1|7.6|
73882918|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|7.6|67.1||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||67.1|7.6|
73882919|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|55.0|||||TWO_SIDED|90.0|19.7|77.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||77.6|19.7|
74064731|NCT03118765|147681530|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.002|TWO_SIDED|95.0|0.06|0.24|||Mixed Models Analysis|||||0.24|0.06|0.002
74064732|NCT03118765|147681530|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.061|TWO_SIDED|95.0|0.0|0.18|||Mixed Models Analysis|||||0.18|-0.00|0.061
74064733|NCT03118765|147681530|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.14|TWO_SIDED|95.0|-0.02|0.16|||Mixed Models Analysis|||||0.16|-0.02|0.140
74064734|NCT03118765|147681530|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.002|TWO_SIDED|95.0|0.06|0.24|||Mixed Models Analysis|||||0.24|0.06|0.002
74064735|NCT01749033|147681560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76|||||||Chi-squared|||We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.||||.76
74064736|NCT01749033|147681562|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.05|TWO_SIDED||||||Chi-squared||The reported p value was calculated.|We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.||||.05
74064737|NCT03056001|147681580|OTHER|Estimation only.|Rate|0.0333|||||TWO_SIDED|95.0|0.0008|0.1722|||||Confidence interval estimated using the Clopper Pearson method.|The reported severe or life-threatening adverse event rate with weekly doxorubicin and dacarbazine was 0.55. If it became evident that the rate of severe or life-threatening toxicity convincingly exceeded 0.55, the study would have been halted. Convincing evidence of exceeding 0.55 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.75 or higher.||0.1722|0.0008|
74064738|NCT03056001|147681581|OTHER|Estimation only|Median|1.3|||||TWO_SIDED|95.0|0.8|2.1|||||The Kaplan Meier method was used to estimate the median OS (in years) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.|||2.1|0.8|
74064739|NCT03056001|147681582|OTHER|Estimation only|Median|5.7|||||TWO_SIDED|95.0|4.1|8.3|||||The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||8.3|4.1|
74064740|NCT03056001|147681583|OTHER|Estimation only.|Rate|0.367|||||TWO_SIDED|95.0|0.199|0.561|||||Confidence interval estimated using the Clopper Pearson method.|||0.561|0.199|
74064741|NCT03056001|147681584|OTHER|Estimation only|Median|8.0|||||TWO_SIDED|95.0|2.8|34.6|||||The Kaplan Meier method was used to estimate the median DoR (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median duration of response.|||34.6|2.8|
74064742|NCT05003167|147681640|SUPERIORITY||F|8.48||||0.001|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.001
74064743|NCT05003167|147681642|SUPERIORITY||F|2.29||||0.113|TWO_SIDED|95.0|||||ANOVA|df = 2,44||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.113
74064744|NCT05003167|147681643|SUPERIORITY||F|3.17||||0.052|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.052
74064745|NCT05003167|147681644|SUPERIORITY||F|0.07||||0.931|TWO_SIDED|95.0|||||ANOVA|||"A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.~Results here are for percent of breaths at major boundaries."||||.931
73882920|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|12.1|||||TWO_SIDED|90.0|-21.4|43.4||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||43.4|-21.4|
73882921|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|3.8|||||TWO_SIDED|90.0|-29.4|36.4||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||36.4|-29.4|
73882922|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|45.5|||||TWO_SIDED|90.0|17.1|69.0||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||69.0|17.1|
74064746|NCT05003167|147681644|SUPERIORITY||F|0.23||||0.164|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05. Results reflect percent of breaths at boundaries unrelated to syntax.||||0.164
74064747|NCT02367781|147681652|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.639|||<|0.0001|TWO_SIDED|95.0|0.536|0.763|||Log Rank|||||0.763|0.536|<.0001
74064748|NCT02367781|147681653|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.788||||0.0298|TWO_SIDED|95.0|0.636|0.977|||Log Rank|||||0.977|0.636|0.0298
74064749|NCT02367781|147681654|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.647|||<|0.0001|TWO_SIDED|95.0|0.545|0.768|||Log Rank|||ITT Population||0.768|0.545|<0.0001
74064750|NCT02367781|147681654|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.561|||<|0.0001|TWO_SIDED|95.0|0.432|0.728|||Log Rank|||TC1/2/3 or IC1/2/3-WT ITT Population||0.728|0.432|<0.0001
74064751|NCT02367781|147681654|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.549|||<|0.0001|TWO_SIDED|95.0|0.425|0.708|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||0.708|0.425|<0.0001
74064752|NCT02367781|147681655|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.837||||0.0732|TWO_SIDED|95.0|0.689|1.017|||Log Rank|||||1.017|0.689|0.0732
74064753|NCT02367781|147681656|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.752||||0.083|TWO_SIDED|95.0|0.545|1.039|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||1.039|0.545|0.0830
74064754|NCT02367781|147681656|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.746||||0.0813|TWO_SIDED|95.0|0.536|1.038|||Log Rank|||TC1/2/3 or IC1/2/3 WT ITT Population||1.038|0.536|0.0813
74064755|NCT02367781|147681657|SUPERIORITY|Stratified Analysis|Difference in Response Rate|19.21|||<|0.0001|TWO_SIDED|95.0|11.05|27.37|||Cochran-Mantel-Haenszel||Wald with Continuity Correction|||27.37|11.05|<.0001
74064756|NCT02367781|147681658|SUPERIORITY|Unstratified Analysis|Difference in Response Rate|16.89|||<|0.0001|TWO_SIDED|95.0|8.9|24.88|||Cochran-Mantel-Haenszel||Wald with Continuity Correction|ITT Population||24.88|8.90|<.0001
74064757|NCT02367781|147681658|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.22|||||TWO_SIDED|95.0|1.38|3.56||||||TC1/2/3 or IC1/2/3 ITT WT Population||3.56|1.38|
74064758|NCT02367781|147681658|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.21||||0.0007|TWO_SIDED|95.0|1.39|3.51|||Cochran-Mantel-Haenszel|||TC1/2/3 or IC1/2/3 ITT Population||3.51|1.39|0.0007
74064759|NCT02367781|147681659|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.614||||0.0002|TWO_SIDED|95.0|0.473|0.797|||Log Rank|||ITT Population||0.797|0.473|0.0002
74064760|NCT02367781|147681659|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.6||||0.0002|TWO_SIDED|95.0|0.458|0.785|||Log Rank|||ITT-WT Population||0.785|0.458|0.0002
74064761|NCT02367781|147681659|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.548||||0.0011|TWO_SIDED|95.0|0.379|0.791|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||0.791|0.379|0.0011
74064762|NCT02367781|147681659|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.551||||0.0014|TWO_SIDED|95.0|0.381|0.798|||Log Rank|||TC1/2/3 or IC1/2/3 ITT WT Population||0.798|0.381|0.0014
74064763|NCT02367781|147681660|SUPERIORITY||Difference in Event Free Rate|7.46||||0.0647|TWO_SIDED|95.0|-0.45|15.37|||Z-test|||Event Free Rate (%) at Year 1 ITT WT Population||15.37|-0.45|0.0647
74064764|NCT02367781|147681660|SUPERIORITY||Difference in Event Free Rate|8.07||||0.0516|TWO_SIDED|95.0|-0.06|16.19|||Z-test|||Event Free Rate (%) at Year 2 ITT WT Population||16.19|-0.06|0.0516
74064765|NCT02367781|147681660|SUPERIORITY||Difference in Event Free Rate|7.19||||0.0683|TWO_SIDED|95.0|-0.54|14.91|||Z-test|||Event Free Rate (%) at Year 1 ITT Population||14.91|-0.54|0.0683
74064766|NCT02367781|147681660|SUPERIORITY||Difference in Event Free Rate|7.53||||0.0625|TWO_SIDED|95.0|-0.39|15.44|||Z-test|||Event Free Rate (%) at Year 2 ITT Population||15.44|-0.39|0.0625
74064767|NCT02367781|147681661|SUPERIORITY||Difference in Event Free Rate|6.69||||0.2385|TWO_SIDED|95.0|-4.44|17.83|||Z-test|||Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT||17.83|-4.44|0.2385
74064768|NCT02367781|147681661|SUPERIORITY||Difference in Event Free Rate|8.64||||0.271|TWO_SIDED|95.0|-6.75|24.03|||Z-test|||Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT||24.03|-6.75|0.2710
74064769|NCT02367781|147681661|SUPERIORITY||Difference in Event Free Rate|6.34||||0.2733|TWO_SIDED|95.0|-5.0|17.67|||Z-test|||Event Free Rate (%) Year 1 TC1/2/3 or IC1/2/3 ITT WT||17.67|-5.00|0.2733
74064770|NCT02367781|147681661|SUPERIORITY||Difference in Event Free Rate|8.69||||0.2909|TWO_SIDED|95.0|-7.44|24.81|||Z-test|||Event Free Rate (%) Year 2 TC1/2/3 or IC1/2/3 ITT WT||24.81|-7.44|0.2909
74064771|NCT02367781|147681662|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.893||||0.3342|TWO_SIDED|95.0|0.711|1.123|||Log Rank|||||1.123|0.711|0.3342
74064772|NCT02517099|147681670|SUPERIORITY||Median Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.384||0.05|TWO_SIDED|95.0|1.591|8.8|||Wilcoxon (Mann-Whitney)|||||8.80|1.591|0.05
74064773|NCT01123980|147681674|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered to be confirmed if the upper bound of the two-sided 95% confidence interval (CI) was below or equal to 0.4% or equivalent if the p-value for the one-sided test of H0: D \> 0.4% against HA: D =\< 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (investigational product minus comparator). Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.07|<|0.001||95.0|-0.25|0.02||The p-values correspond to one-sided hypotheses of either non-inferiority or superiority, statistical significance level is 2.5%.|ANCOVA|The estimates are from a normal linear regression model with treatment, country and previous OADs as factors and baseline HbA1c as a covariate||H0: The mean treatment difference (BIAsp 30 minus insulin glargine) \> 0.4%. HA: The mean treatment difference (BIAsp 30 minus insulin glargine) =\< 0.4%. Sample size was calculated to achieve a power of at least 90%, assuming an equal change in HbA1c and a common standard deviation of 1.25%||0.02|-0.25|< 0.001
74064774|NCT01123980|147681675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||<|0.001||95.0|-0.24|0.19||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.19|-0.24|<0.001
74064775|NCT01123980|147681675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||<|0.001||95.0|-0.45|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.58|-0.45|<0.001
74064776|NCT01123980|147681675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|-0.31|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.58|-0.31|<0.001
74064777|NCT01123980|147681675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||<|0.001||95.0|-0.26|0.82||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.82|-0.26|<0.001
74064778|NCT01123980|147681675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|||<|0.001||95.0|0.22|1.06||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||1.06|0.22|<0.001
74064779|NCT01123980|147681675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|||<|0.001||95.0|-2.03|-1.0||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-1.00|-2.03|<0.001
74064780|NCT01123980|147681675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|||<|0.001||95.0|-1.73|-0.78||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Bedtime|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-0.78|-1.73|<0.001
74064781|NCT01123980|147681675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001||95.0|-0.81|-0.13||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||02 - 04 a.m.|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-0.13|-0.81|<0.001
74064782|NCT01123980|147681675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.001||95.0|-0.06|0.4||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast the following day|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.40|-0.06|<0.001
74064783|NCT01123980|147681676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8583||95.0|0.64|1.46|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c less than 7% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.||1.46|0.64|0.8583
74064784|NCT01123980|147681677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8013||95.0|0.64|1.79|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c below or equal to 6.5% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.||1.79|0.64|0.8013
74064785|NCT02094937|147681686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.31|2.49||||||||2.49|0.31|
74064786|NCT02094937|147681686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.28|2.19||||||||2.19|0.28|
74064787|NCT02094937|147681687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.9|4.12||||||||4.12|0.90|
74064788|NCT02094937|147681687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|0.66|3.2||||||||3.20|0.66|
74064789|NCT01133392|147681694|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.99|||||TWO_SIDED|90.0|0.948|1.034||||||||1.034|0.948|
74064790|NCT01133392|147681695|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.933|||||TWO_SIDED|90.0|0.897|0.972||||||||0.972|0.897|
74064791|NCT01133392|147681696|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.005|||||TWO_SIDED|90.0|0.958|1.054||||||||1.054|0.958|
74064792|NCT01133392|147681697|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-0.4|0.5||||||||0.500|-0.400|
73882923|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|36.4|||||TWO_SIDED|90.0|1.9|63.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||63.4|1.9|
74064793|NCT01133392|147681698|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.014|||||TWO_SIDED|90.0|0.961|1.07||||||||1.070|0.961|
74064794|NCT01335399|147681734|SUPERIORITY|||||||0.4358|||||||Stratified Log Rank|||||||0.4358
73882924|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|14.5|||||TWO_SIDED|90.0|-21.4|47.0||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||47.0|-21.4|
74064795|NCT01335399|147681734|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.71|0.77|1.12|||||E-Ld/Ld. Calculated using Cox proportional hazards modeling|||1.12|0.77|
74064796|NCT01335399|147681735|SUPERIORITY||CMH ESTIMATE OF COMMON ODDS RATIO|1.26||||0.2232|TWO_SIDED|95.0|0.87|1.82|||CMH ESTIMATE OF COMMON ODDS RATIO|||||1.82|0.87|0.2232
74064797|NCT01335399|147681736|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.8932|TWO_SIDED|95.0|0.82|1.19|||Stratified log rank test||Stratified by stage of disease (International Staging System 1 - 2 vs 3), age (\<75 years old vs \>= 75 years old) and ECOG performance status (0 vs 1 - 2) at randomization.|||1.19|0.82|0.8932
74064798|NCT01335399|147681738|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.4358|TWO_SIDED|95.0|0.78|1.12|||Hazard Ratio|||||1.12|0.78|0.4358
74064799|NCT02464059|147681741|SUPERIORITY||Mean Difference (Final Values)|-65.5|STANDARD_DEVIATION|207.8||0.21|TWO_SIDED|95.0|-172.4|41.3||P-value is not adjusted for multiple comparisons. A priori threshold for significance is p\<0.05.|t-test, 2 sided|||||41.3|-172.4|0.21
74064800|NCT02464059|147681742|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_DEVIATION|12.6||0.86|TWO_SIDED|95.0|-7.02|5.91||P-value is not adjusted for multiple comparisons. A priori threshold for significance is p\<0.05.|t-test, 2 sided|||||5.91|-7.02|0.86
74064801|NCT01406873|147681764|SUPERIORITY||||||<|0.01|||||||ANCOVA|||||||<0.01
74064802|NCT03990389|147681768|SUPERIORITY|||||||0.0618||||||Three degrees of freedom for the interaction test|Mixed Models Analysis|||||||0.0618
74064803|NCT03990389|147681768|SUPERIORITY||estimated treatment effect at month 1|-2.29|STANDARD_ERROR_OF_MEAN|1.8||0.63|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.63
74064804|NCT03990389|147681768|SUPERIORITY||estimated treatment effect at month 2|-5.19|STANDARD_ERROR_OF_MEAN|1.9||0.018|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.018
74064805|NCT03990389|147681768|SUPERIORITY||estimated treatment effect at month 3|-3.3|STANDARD_ERROR_OF_MEAN|1.9||0.234|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.234
74064806|NCT03990389|147681769|OTHER|||||||0.116|||||||t-test, 2 sided|||||||0.116
74064807|NCT00207714|147681774|SUPERIORITY_OR_OTHER|||||||0.01||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Week 16 between combined golimumab groups and Placebo +MTX group. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25 % response in Placebo +MTX.||||0.010
74064808|NCT00207714|147681774|SUPERIORITY_OR_OTHER|||||||0.056|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between golimumab 50 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.056
74064809|NCT00207714|147681774|SUPERIORITY_OR_OTHER|||||||0.281|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 50 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.281
74064810|NCT00207714|147681774|SUPERIORITY_OR_OTHER|||||||0.119|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.119
74064811|NCT00207714|147681774|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||<0.001
74064812|NCT00207714|147681775|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and combined golimumab groups.||||0.001
74064813|NCT00207714|147681775|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 4 weeks||||0.006
74064814|NCT00207714|147681775|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 2 or 4 Weeks||||0.095
74064815|NCT00207714|147681775|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA on van der Waerden normal scores.|ANOVA on van der Waerden normal scores||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golibumab 100 mg every 4 weeks||||0.010
74064816|NCT00207714|147681775|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golimumab 100 mg every 2 or 4 Weeks||||<0.001
74064817|NCT02290028|147681840|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||Primary endpoint 1 was evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 6 months) to the performance goal of 90.0%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 90.0%.||||<0.0001
74064818|NCT02290028|147681841|SUPERIORITY||||||=|0.002|||||||Exact, binomial|||Primary endpoint 2 was evaluated by performing an exact, binomial test comparing an observed proportion (rate of acceptable LV pacing thresholds at the permanently programmed pacing vector at 3 months) to 88%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the percentage of subjects with an acceptable LV pacing threshold in the permanently programmed pacing vector must be greater than 88.0%.||||=0.002
74064819|NCT02290028|147681842|SUPERIORITY|||||||||||||||||Primary endpoint 3 will be evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 5 years) to the performance goal of 92.5%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 92.5%|On September 24, 2019, BIOTRONIK received FDA approval to transition the ongoing Sentus Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.|||
74064820|NCT03202511|147681851|EQUIVALENCE|0.8 to 1.25 equivalence margin was used.|Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.47|1.77||||||||1.77|1.47|
74064821|NCT03202511|147681852|EQUIVALENCE|80 to 125% equivalence margin was used.|Geometric Mean Ratio|77.4|||||TWO_SIDED|90.0|61.4|97.6||||||||97.6|61.4|
74064822|NCT00265083|147681860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs II and Groups I vs III. The sample size of 75 patients (pts) in placebo and 135 pts per active group will provide \>=99% power to detect a difference in ASAS 20 response between treatment groups at alpha=0.05, assuming 50% of pts with screening CRP\<1.5mg/dL, and the difference in ASAS 20 response of 10-27.5% in pts with screening CRP\<1.5mg/dL and 32.5-45% in pts with screening CRP\>=1.5mg/dL, between Groups I vs II or III.||||<0.001
74064823|NCT00265083|147681860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||||||<0.001
74064824|NCT00265083|147681860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||||||<0.001
74064825|NCT00265083|147681861|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs. II and Groups I vs. III.||||<0.001
74064826|NCT00265083|147681861|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group II and Group I.||||<0.001
74064827|NCT00265083|147681861|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group III and Group I.||||<0.001
74064828|NCT00265083|147681862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASFI comparing Groups I vs. II and Groups I vs. III.||||<0.001
74064829|NCT00265083|147681862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group II and Group I.||||<0.001
74064830|NCT00265083|147681862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group III and Group I.||||<0.001
74064831|NCT00265083|147681863|SUPERIORITY_OR_OTHER|||||||0.288||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASMI comparing Groups I vs. II and Groups I vs. III.||||0.288
74064832|NCT00265083|147681863|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group II and Group I.||||0.444
74064833|NCT00265083|147681863|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group III and Group I.||||0.247
74064834|NCT00661674|147681887|SUPERIORITY_OR_OTHER|||||||0.0001||||||p-value represents comparison between OOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in OOWS scores when comparing treatment groups (Palonosetron \& Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."||||0.0001
74064835|NCT00661674|147681888|SUPERIORITY_OR_OTHER|||||||0.2244||||||p-value represents comparison between SOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in SOWS scores when comparing the 2 treatment groups (Palonosetron \& Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."||||0.2244
74064836|NCT02629133|147681960|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.560
74064837|NCT02629133|147681960|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Differences between conditions in the change in % heavy drinking/using days from baseline to 6 months||||0.760
74064838|NCT02629133|147681961|SUPERIORITY|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
74064839|NCT02629133|147681961|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||Distributions were badly skewed, and the sample was too small for ZINB or other analyses. Therefore, we analyzed differences between conditions in changes in services/day over time (i.e., from baseline to 6 month post-shelter follow-up) using the Mann-Whitney U.||||0.029
74064840|NCT02629133|147681962|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.325|TWO_SIDED|95.0|-4.5|13.5||We used hierarchical linear modeling (HLM) to predict 3-mo and 6-mo post-shelter scores from treatment condition, using baseline score as a covariate.|Mixed Models Analysis|||||13.5|-4.5|0.325
74064841|NCT02629133|147681963|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.192|TWO_SIDED|95.0|-0.61|2.98||We used HLM to predict Cyber-Stalking Scores across 3 and 6 month post shelter follow-up points from treatment condition, using baseline score as a covariate.|Mixed Models Analysis||Higher scores represent more cyber-stalking over follow-up.|||2.98|-0.61|0.192
74064842|NCT02629133|147681964|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.119|TWO_SIDED|95.0|-3.24|0.38||We conducted HLM predicting SBC Total scores at 3 and 6 months post-shelter release from treatment condition, using baseline SBC score as a covariate.|Mixed Models Analysis||Higher is better (reflecting more safety behaviors used).|||0.38|-3.24|0.119
73882925|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|24.5|||||TWO_SIDED|90.0|-11.8|54.9||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||54.9|-11.8|
74064843|NCT01507831|147681966|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.9|||<|0.0001|TWO_SIDED|95.0|-64.3|-59.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-59.4|-64.3|<0.0001
73882926|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|-4.5|||||TWO_SIDED|90.0|-40.4|32.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||32.3|-40.4|
74064844|NCT01507831|147681967|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.5|||<|0.0001|TWO_SIDED|95.0|-65.9|-61.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchial testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchial testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-61.2|-65.9|<0.0001
74064845|NCT01507831|147681968|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.8|||<|0.0001|TWO_SIDED|95.0|-67.2|-62.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-62.4|-67.2|<0.0001
74064846|NCT01507831|147681969|SUPERIORITY_OR_OTHER||LS Mean Difference|-65.5|||<|0.0001|TWO_SIDED|95.0|-67.9|-63.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-63.2|-67.9|<0.0001
74064847|NCT01507831|147681970|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.3|||<|0.0001|TWO_SIDED|95.0|-64.0|-58.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-58.5|-64.0|<0.0001
74064848|NCT01507831|147681971|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.0|||<|0.0001|TWO_SIDED|95.0|-56.3|-51.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.7|-56.3|<0.0001
74064849|NCT01507831|147681972|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.5|||<|0.0001|TWO_SIDED|95.0|-57.7|-53.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.2|-57.7|<0.0001
74064850|NCT01507831|147681973|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.3|||<|0.0001|TWO_SIDED|95.0|-54.4|-50.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50.2|-54.4|<0.0001
73882927|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|13.6|||||TWO_SIDED|90.0|-23.7|48.2||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||48.2|-23.7|
74064851|NCT01507831|147681974|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.7|||<|0.0001|TWO_SIDED|95.0|-55.7|-51.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.6|-55.7|<0.0001
74064852|NCT01507831|147681975|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-39.1|-35.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35.9|-39.1|<0.0001
73882928|NCT02201524|147299773|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-28.0|49.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|-28.0|
74064853|NCT01507831|147681976|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.0|||<|0.0001|TWO_SIDED|95.0|-58.3|-53.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.7|-58.3|<0.0001
74064854|NCT01507831|147681977|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.6|||<|0.0001|TWO_SIDED|95.0|-56.6|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-52.6|-56.6|<0.0001
74064855|NCT01507831|147681978|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-40.4|-37.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-37.5|-40.4|<0.0001
74064856|NCT01507831|147681979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.5|||<|0.0001|TWO_SIDED|95.0|51.6|99.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||99.1|51.6|<0.0001
74064857|NCT01507831|147681980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|93.4|||<|0.0001|TWO_SIDED|95.0|66.1|132.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||132.0|66.1|<0.0001
74064858|NCT01507831|147681981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|74.6|||<|0.0001|TWO_SIDED|95.0|53.3|104.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||104.4|53.3|<0.0001
74064859|NCT01507831|147681982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|97.3|||<|0.0001|TWO_SIDED|95.0|68.2|138.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||138.9|68.2|<0.0001
74064860|NCT01507831|147681983|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-28.1|-23.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.1|-28.1|<0.0001
74064861|NCT01507831|147681984|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6|||<|0.0001|TWO_SIDED|95.0|3.3|5.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.9|3.3|<0.0001
74064862|NCT01507831|147681985|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-20.1|-14.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-14.6|-20.1|<0.0001
74064863|NCT01507831|147681986|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||<|0.0001|TWO_SIDED|95.0|1.6|4.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.2|1.6|<0.0001
74064864|NCT01507831|147681987|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-27.4|-22.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.7|-27.4|<0.0001
74064865|NCT01507831|147681988|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6|||<|0.0001|TWO_SIDED|95.0|4.3|6.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||6.8|4.3|<0.0001
74064866|NCT01507831|147681989|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.9|||<|0.0001|TWO_SIDED|95.0|-20.5|-15.3||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-15.3|-20.5|<0.0001
74064867|NCT01507831|147681990|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|||<|0.0001|TWO_SIDED|95.0|2.8|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.2|2.8|<0.0001
74064868|NCT02295280|147682004|SUPERIORITY|||||||0.14||||||Reduction in pain scores by at least 2 units six hours post administration|Mann Whitney U test|Mann Whitney U test used for analysis of this continuous variable as data were not normally distributed. Outcome was comparable at the 6-hour mark.||A sample size calculation of 35 patients in each group was based on an estimated reduction in headache pain score by at least two points, with an a of 0.05 and power of 90%, which is similar to estimates reported in prior studies in non-pregnant patients and felt to be a clinically significant decrease. Statistical analyses were performed using chi-square, Fisher's exact test for categorical variables, the independent Student's t-test and Kolmogorov-Smirnov for continuous variables.||||0.14
74064869|NCT02766400|147682048|SUPERIORITY_OR_OTHER_LEGACY||Cohen's d effect size at 12 months|0.53|||<|0.001|TWO_SIDED|95.0|-0.12|1.19||a priori threshold was set at p\<0.05|Linear mixed models|F(4,150)=5.11|Effect size was calculated using mean change scores (baseline to month 12) and standard error of change (baseline to month 12) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||1.19|-0.12|<0.001
74064870|NCT00204932|147682049|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis was based on test-retest variance of body fat mass measure by DEXA|||||<|0.05||95.0|||||ANOVA|||Analysis of variance to test CLA not equal to placebo||||<0.05
74064871|NCT00204932|147682049|SUPERIORITY||||||<|0.05|||||||ANOVA|||Pre- post treatment comparison o fat oxidation found that fat oxidation increased in CLA (4 +/- 8 g) and decreased in placebo (-7 +/- 11 g) groups during sleep. after 6 mo of supplementation.||||<0.05
74064872|NCT03593772|147682051|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.04819|STANDARD_ERROR_OF_MEAN|0.02482||0.0535|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total POQ Score as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.0535
74064873|NCT03593772|147682051|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00163|STANDARD_ERROR_OF_MEAN|0.001826||0.3729|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Rating as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.3729
74064874|NCT03593772|147682051|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00593|STANDARD_ERROR_OF_MEAN|0.007228||0.4124|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Mobility as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.4124
74064875|NCT03593772|147682051|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00432|STANDARD_ERROR_OF_MEAN|0.009334||0.6442|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities of Daily Living as outcome variable. Linear mixed models were constructed with fixed effects terms for treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test if the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.6442
74064876|NCT03593772|147682051|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00898|STANDARD_ERROR_OF_MEAN|0.006436||0.1641|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Vitality as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.1641
74064877|NCT03593772|147682051|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.01952|STANDARD_ERROR_OF_MEAN|0.009846||0.0487|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Neg. Affect as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.0487
74064878|NCT03593772|147682051|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0066|STANDARD_ERROR_OF_MEAN|0.004644||0.1554|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Fear as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.1554
74064879|NCT03593772|147682052|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00113|STANDARD_ERROR_OF_MEAN|0.000863||0.1924|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1924
74064880|NCT03593772|147682052|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0019|STANDARD_ERROR_OF_MEAN|0.001152||0.1002|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stress as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1002
74064881|NCT03593772|147682052|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000343|STANDARD_ERROR_OF_MEAN|0.000996||0.7311|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Tension as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7311
74064882|NCT03593772|147682053|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00241|STANDARD_ERROR_OF_MEAN|0.001716||0.1622|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1622
74064883|NCT03593772|147682053|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00235|STANDARD_ERROR_OF_MEAN|0.002052||0.254|TWO_SIDED||||||Mixed Models Analysis|||Analysis performed on Pain Interference with Activity as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2540
74064884|NCT03593772|147682053|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00612|STANDARD_ERROR_OF_MEAN|0.002297||0.0082|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Sleep as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0082
74064885|NCT03593772|147682053|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00636|STANDARD_ERROR_OF_MEAN|0.002378||0.0079|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Mood as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0079
74064886|NCT03593772|147682053|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00334|STANDARD_ERROR_OF_MEAN|0.002367||0.1588|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Stress as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1588
74064887|NCT03593772|147682054|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00974|STANDARD_ERROR_OF_MEAN|0.01379||0.4808|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PCL-5 Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4808
74064888|NCT03593772|147682055|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00033|STANDARD_ERROR_OF_MEAN|0.00856||0.9692|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Physical Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9692
74064889|NCT03593772|147682055|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.01738|STANDARD_ERROR_OF_MEAN|0.007848||0.0277|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Mental Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0277
74064890|NCT03593772|147682056|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00188|STANDARD_ERROR_OF_MEAN|0.003253||0.5642|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total PSQI Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.5642
74064891|NCT03593772|147682056|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00092|STANDARD_ERROR_OF_MEAN|0.00079||0.2438|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Subjective Sleep Quality Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2438
74064892|NCT03593772|147682056|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000304|STANDARD_ERROR_OF_MEAN|0.000885||0.7317|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep latency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7317
74064893|NCT03593772|147682056|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00062|STANDARD_ERROR_OF_MEAN|0.001327||0.6393|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep duration Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6393
74064894|NCT03593772|147682056|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00112|STANDARD_ERROR_OF_MEAN|0.000873||0.1995|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep efficiency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1995
73882929|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
73882930|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.1|||||TWO_SIDED|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||10.2|-27.0|
73882931|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|8.2|||||TWO_SIDED|90.0|-14.4|32.2||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||32.2|-14.4|
74064895|NCT03593772|147682056|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00072|STANDARD_ERROR_OF_MEAN|0.000675||0.2886|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep disturbance Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2886
74064896|NCT03593772|147682056|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002048|STANDARD_ERROR_OF_MEAN|0.001356||0.1323|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Use of sleep medication Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1323
74064897|NCT03593772|147682056|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000209|STANDARD_ERROR_OF_MEAN|0.000793||0.7923|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Daytime dysfunction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7923
74064898|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00046|STANDARD_ERROR_OF_MEAN|0.001074||0.6679|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6679
74064899|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001083|STANDARD_ERROR_OF_MEAN|0.000769||0.1607|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1607
74064900|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000984|STANDARD_ERROR_OF_MEAN|0.00064||0.126|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS- Total as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1260
74064901|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000909|STANDARD_ERROR_OF_MEAN|0.000933||0.3311|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3311
74064902|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001041|STANDARD_ERROR_OF_MEAN|0.000887||0.2416|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2416
73882932|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-6.7|43.6||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||43.6|-6.7|
74064903|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00087|STANDARD_ERROR_OF_MEAN|0.001016||0.3903|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3903
74064904|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001186|STANDARD_ERROR_OF_MEAN|0.00095||0.2131|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2131
74064905|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001485|STANDARD_ERROR_OF_MEAN|0.000933||0.113|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1130
74064906|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001983|STANDARD_ERROR_OF_MEAN|0.000939||0.0358|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0358
74064907|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00019|STANDARD_ERROR_OF_MEAN|0.000495||0.7027|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS- Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7027
74064908|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000761|STANDARD_ERROR_OF_MEAN|0.00073||0.2979|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2979
74064909|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00063|STANDARD_ERROR_OF_MEAN|0.000798||0.4278|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4278
74064910|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0000074|STANDARD_ERROR_OF_MEAN|0.000877||0.9933|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9933
74064911|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00115|STANDARD_ERROR_OF_MEAN|0.000816||0.1589|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1589
74064912|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000109|STANDARD_ERROR_OF_MEAN|0.000767||0.8875|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.8875
74064913|NCT03593772|147682057|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00032|STANDARD_ERROR_OF_MEAN|0.00078||0.6859|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6859
74064914|NCT03593772|147682058|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.01408|STANDARD_ERROR_OF_MEAN|0.01085||0.1959|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on BDI total score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1959
73882933|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.7|||||TWO_SIDED|90.0|-28.8|12.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||12.1|-28.8|
73882934|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|32.3|||||TWO_SIDED|90.0|5.4|55.4||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.4|5.4|
73882935|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|28.7|||||TWO_SIDED|90.0|0.8|55.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.3|0.8|
74064915|NCT03593772|147682059|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00788|STANDARD_ERROR_OF_MEAN|0.005845||0.1792|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Perceived Stress Scale Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1792
74064916|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00132|STANDARD_ERROR_OF_MEAN|0.01039||0.8991|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total RDAS as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.8991
74064917|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002105|STANDARD_ERROR_OF_MEAN|0.002349||0.3711|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3711
74064918|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001864|STANDARD_ERROR_OF_MEAN|0.002348||0.428|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4280
74064919|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00007|STANDARD_ERROR_OF_MEAN|0.003205||0.9831|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Affection Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9831
74064920|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.003052|STANDARD_ERROR_OF_MEAN|0.006364||0.632|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6320
74064921|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00007|STANDARD_ERROR_OF_MEAN|0.002259||0.9755|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9755
73882936|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|90.0|-27.3|27.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||27.3|-27.3|
73882937|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|33.3|||||TWO_SIDED|90.0|1.0|59.8||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||59.8|1.0|
73882938|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|43.3|||||TWO_SIDED|90.0|8.8|69.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||69.3|8.8|
73882939|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|2.1|49.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|2.1|
74064922|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00056|STANDARD_ERROR_OF_MEAN|0.001818||0.7584|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7584
73882940|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|50.0|||||TWO_SIDED|90.0|25.4|71.8||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||71.8|25.4|
73882941|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|66.7|||||TWO_SIDED|90.0|39.2|86.1||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||86.1|39.2|
74064923|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000297|STANDARD_ERROR_OF_MEAN|0.003444||0.9313|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9313
74064924|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00129|STANDARD_ERROR_OF_MEAN|0.002097||0.5401|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.5401
74064925|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00018|STANDARD_ERROR_OF_MEAN|0.002471||0.9421|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9421
74064926|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00151|STANDARD_ERROR_OF_MEAN|0.003983||0.7042|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7042
74064927|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.02128|STANDARD_ERROR_OF_MEAN|0.008331||0.0114|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total RDAS Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0114
74064928|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002587|STANDARD_ERROR_OF_MEAN|0.001727||0.1358|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1358
74064929|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001402|STANDARD_ERROR_OF_MEAN|0.001796||0.4354|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4354
73882942|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|-9.1|||||TWO_SIDED|90.0|-36.3|18.3||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||18.3|-36.3|
73882943|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|41.8|||||TWO_SIDED|90.0|6.2|68.5||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||68.5|6.2|
74064930|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.005759|STANDARD_ERROR_OF_MEAN|0.002113||0.007|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on AffectionSubdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0070
74064931|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.01037|STANDARD_ERROR_OF_MEAN|0.004485||0.0217|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0217
74064932|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00039|STANDARD_ERROR_OF_MEAN|0.001461||0.7881|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7881
74064933|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.004717|STANDARD_ERROR_OF_MEAN|0.00141||0.001|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0010
74064934|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.004393|STANDARD_ERROR_OF_MEAN|0.002415||0.0693|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0693
74064935|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002959|STANDARD_ERROR_OF_MEAN|0.001887||0.1184|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1184
74064936|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.003436|STANDARD_ERROR_OF_MEAN|0.002262||0.1301|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1301
74064937|NCT03593772|147682060|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.006022|STANDARD_ERROR_OF_MEAN|0.003697||0.1049|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1049
74064938|NCT02731833|147682067|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.505|-0.3|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as factor and baseline Schiff sensitivity score as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|Statistical analyses was conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||-0.300|-0.505|<0.0001
73882944|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|31.8|||||TWO_SIDED|90.0|-2.9|60.5||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||60.5|-2.9|
74064939|NCT05788237|147682128|OTHER||GMR|0.84|||||TWO_SIDED|95.0|0.662|1.062||||||GMR for RSV A: RSVpreF + qIRV combination to RSVpreF alone.||1.062|0.662|
74064940|NCT05788237|147682128|OTHER||GMR|0.79|||||TWO_SIDED|95.0|0.614|1.013||||||GMR for RSV B: RSVpreF + qIRV combination to RSVpreF alone.||1.013|0.614|
74064941|NCT05788237|147682129|OTHER||GMR|0.81|||||TWO_SIDED|95.0|0.632|1.044||||||GMR for HAI: H1N1 A/Wisconsin: RSVpreF + qIRV combination to RSVpreF alone.||1.044|0.632|
74064942|NCT05788237|147682129|OTHER||Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.567|0.957||||||GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV combination to RSVpreF alone.||0.957|0.567|
74064943|NCT05788237|147682129|OTHER||GMR|0.94|||||TWO_SIDED|95.0|0.741|1.181||||||GMR for HAI: B/Austria: RSVpreF + qIRV combination to RSVpreF alone.||1.181|0.741|
74064944|NCT05788237|147682129|OTHER||GMR|0.91|||||TWO_SIDED|95.0|0.707|1.174||||||GMR for HAI: B/Phuket: RSVpreF + qIRV combination to RSVpreF alone.||1.174|0.707|
73882945|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|-15.9|||||TWO_SIDED|90.0|-47.8|13.7||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||13.7|-47.8|
73882946|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|-6.8|||||TWO_SIDED|90.0|-40.6|24.8||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||24.8|-40.6|
74064945|NCT05788237|147682130|OTHER||Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.82|1.339||||||GMR for RSV A: RSVpreF + qIRV 1.0 mL (Group 1) combination to RSVpreF + qIRV 0.5 mL (Group 2)||1.339|0.820|
74064946|NCT05788237|147682130|OTHER||Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.833|1.352||||||GMR for RSV B: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.352|0.833|
74064947|NCT05788237|147682131|OTHER||GMR|1.19|||||TWO_SIDED|95.0|0.875|1.614||||||GMR for HAI: H1N1 A/Sydney: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.614|0.875|
74064948|NCT05788237|147682131|OTHER||Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.867|1.473||||||GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.473|0.867|
74064949|NCT05788237|147682131|OTHER||Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.849|1.383||||||GMR for HAI: B/Austria: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.383|0.849|
74064950|NCT05788237|147682131|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.866|1.392||||||GMR for HAI: B/Phuket: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.392|0.866|
74064951|NCT02842086|147682132|NON_INFERIORITY|Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.|Rate Ratio|0.468|||||TWO_SIDED|95.003|0.191|1.149||||||Noninferiority was assessed using a 95.003% confidence interval (CI) constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.||1.149|0.191|
73882947|NCT02201524|147299774|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|90.0|-36.4|36.4||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||36.4|-36.4|
73882948|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
73882949|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.1|||||TWO_SIDED|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||10.2|-27.0|
73882950|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|0.5|||||TWO_SIDED|90.0|-20.7|22.8||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||22.8|-20.7|
73882951|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|1.2|||||TWO_SIDED|90.0|-20.3|24.8||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||24.8|-20.3|
73882952|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|13.3|||||TWO_SIDED|90.0|-5.6|33.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||33.8|-5.6|
73882953|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|36.4|||||TWO_SIDED|90.0|15.3|61.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||61.1|15.3|
74064952|NCT02842086|147682133|SUPERIORITY||Difference in least squares mean (LSM)|1.142|||<|0.0001|TWO_SIDED|95.0|0.628|1.655|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using analysis of variance (ANOVA), which included baseline TVD for pre-exposure prophylaxis (PrEP) and treatment as fixed effects.||1.655|0.628|<0.0001
74064953|NCT02842086|147682134|SUPERIORITY||Difference in LSM|1.567|||<|0.0001|TWO_SIDED|95.0|0.913|2.22|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||2.220|0.913|<0.0001
74064954|NCT02842086|147682135|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
74064955|NCT02842086|147682136|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
74064956|NCT02842086|147682137|SUPERIORITY|||||||0.0048||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus \> 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance|||||||0.0048
74064957|NCT02842086|147682138|SUPERIORITY||Difference in LSM|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the analysis of covariance (ANCOVA) model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.||-0.01|-0.02|<0.0001
74064958|NCT02842086|147682139|NON_INFERIORITY|Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.|Rate Ratio|0.536|||||TWO_SIDED|95.003|0.227|1.264||||||Noninferiority was assessed using a 95.003% CI constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.||1.264|0.227|
74064959|NCT02842086|147682140|SUPERIORITY||Difference in LSM|1.567|||<|0.0001|TWO_SIDED|95.0|0.896|2.237|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||2.237|0.896|<0.0001
73882954|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|33.3|||||TWO_SIDED|90.0|11.3|57.3||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||57.3|11.3|
74064960|NCT02842086|147682141|SUPERIORITY||Difference in LSM|2.253|||<|0.0001|TWO_SIDED|95.0|1.437|3.069|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||3.069|1.437|<0.0001
74064961|NCT02842086|147682142|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
74064962|NCT02842086|147682143|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
74064963|NCT02842086|147682144|SUPERIORITY|||||||0.2163||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus \> 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance|||||||0.2163
74064964|NCT02842086|147682145|SUPERIORITY||Difference in LSM|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the ANCOVA model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.||-0.01|-0.02|<0.0001
74064965|NCT03751124|147682148|OTHER|Chi-square test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Treatment difference|63.36|||<|0.0001|TWO_SIDED|95.0|52.85|73.86||P-value was based on the stratified test statistics via log-log transformation of the difference in survival curve at a fixed time point stratified by pivotal study baseline MBL volume and duration of prior exposure to relugolix.|Log-Log transformation|Log-Log transformation of survival curve based on stratified Kaplan-Meier analysis|The 95% confidence interval (CI) of treatment difference was calculated via linear transformation of the difference in survival function with pooled variance.|The primary efficacy analysis was the comparison of the relugolix plus E2/NETA group with the placebo group with respect to responder rate.||73.86|52.85|<0.0001
74064966|NCT03751124|147682149|OTHER|Stratified log-rank test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Hazard Ratio (HR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.08|0.2||P-value for comparison of relugolix plus E2/NETA to placebo was based on the stratified log-rank test.|Log Rank||Hazard ratio (95% CI) of relugolix plus E2/NETA to placebo was based on a proportional hazard model stratified by pivotal study baseline MBL volume (\<225 mL or ≥225 mL) and duration of prior exposure to relugolix (28 weeks or 52 weeks).|||0.20|0.08|<0.0001
74064967|NCT03751124|147682150|OTHER|Chi-square test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Treatment difference|58.04|||<|0.0001|TWO_SIDED|95.0|46.97|69.11||P-value was based on the stratified test statistics via log-log transformation of the difference in survival curve at a fixed time point stratified by pivotal study baseline MBL volume and duration of prior exposure to relugolix.|Log-Log transformation|Log-Log transformation of survival curve based on stratified Kaplan-Meier analysis|The 95% CI of treatment difference was calculated via linear transformation of the difference in survival function with pooled variance.|||69.11|46.97|<0.0001
74064968|NCT03751124|147682151|SUPERIORITY||Treatment difference|44.12|||<|0.0001|TWO_SIDED|95.0|33.13|55.11||P-value for difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by pivotal study baseline MBL volume (\<225 mL or ≥225 mL) and duration of prior exposure to relugolix (28 weeks or 52 weeks).|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||55.11|33.13|<0.0001
74064969|NCT01928446|147682207|SUPERIORITY||Cox Proportional Hazard|1.1||||0.61|TWO_SIDED|95.0|0.77|1.55|||Log Rank|||Model1 - Treatment only: unadjusted for other covariates||1.55|0.77|0.61
74064970|NCT01928446|147682207|SUPERIORITY||Cox Proportional Hazard|1.08||||0.67|TWO_SIDED|95.0|0.76|1.53|||Log Rank|||Model2 - Treatment only: unadjusted with Site as random Effect||1.53|0.76|0.67
74064971|NCT01928446|147682208|SUPERIORITY||Cox Proportional Hazard|1.49||||0.37|TWO_SIDED|95.0|0.61|3.64|||Log Rank|||||3.64|0.61|0.37
74064972|NCT01928446|147682209|SUPERIORITY||Cox Proportional Hazard|1.14||||0.77|TWO_SIDED|95.0|0.48|2.69|||Log Rank|||Model 5: Non-fatal self-directed violence subgroup||2.69|0.48|0.77
74064973|NCT01928446|147682209|SUPERIORITY||Cox Proportional Hazard|1.61||||0.22|TWO_SIDED|95.0|0.75|3.43|||Log Rank|||Model 6: Interrupted self-directed violence subgroup||3.43|0.75|0.22
74064974|NCT01928446|147682209|SUPERIORITY||Cox Proportional Hazard|0.92||||0.71|TWO_SIDED|95.0|0.58|1.45|||Log Rank|||Model 7: Hospitalization to prevent suicide||1.45|0.58|0.71
74064975|NCT00830063|147682226|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.76|-0.72||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Least square (LS) mean was estimated from the corresponding analysis of covariance (ANCOVA) model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95 percent (%) confidence interval (CI) was calculated on LS mean difference.||-0.72|-1.76|<0.001
74064976|NCT00830063|147682226|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.52|-0.49||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.49|-1.52|<0.001
74064977|NCT00830063|147682226|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.26||0.007|TWO_SIDED|95.0|-1.23|-0.2||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.20|-1.23|0.007
74064978|NCT00830063|147682226|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.26||0.068|TWO_SIDED|95.0|-0.99|0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.03|-0.99|0.068
74064979|NCT00830063|147682227|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.73|-0.77||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.77|-1.73|<0.001
73882955|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|60.0|||||TWO_SIDED|90.0|34.7|80.9||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||80.9|34.7|
73882956|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|2.1|49.3||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|2.1|
74064980|NCT00830063|147682227|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.51|-0.55||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.55|-1.51|<0.001
73882957|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|44.4|||||TWO_SIDED|90.0|19.4|70.2||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||70.2|19.4|
73882958|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|20.0|||||TWO_SIDED|90.0|-2.7|46.6||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||46.6|-2.7|
74064981|NCT00830063|147682227|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.24||0.002|TWO_SIDED|95.0|-1.24|-0.28||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.28|-1.24|0.002
74064982|NCT00830063|147682227|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.24||0.03|TWO_SIDED|95.0|-1.01|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-1.01|0.030
74064983|NCT00830063|147682228|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.16||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.16|-0.50|<0.001
74064984|NCT00830063|147682228|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.09||0.014|TWO_SIDED|95.0|-0.39|-0.04||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.04|-0.39|0.014
74064985|NCT00830063|147682228|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.09||0.026|TWO_SIDED|95.0|-0.36|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.36|0.026
74064986|NCT00830063|147682228|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.349|TWO_SIDED|95.0|-0.25|0.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.09|-0.25|0.349
74064987|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
74064988|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
74064989|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
74064990|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
73882959|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|30.0|||||TWO_SIDED|90.0|6.4|56.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||56.4|6.4|
74064991|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.65|-0.7||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.70|-1.65|<0.001
74064992|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.13|-2.07|<0.001
74064993|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.24||0.274|TWO_SIDED|95.0|-0.73|0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.21|-0.73|0.274
74064994|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.22|-1.16|0.004
74064995|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.74|-0.75||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.75|-1.74|<0.001
74064996|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.0|-1.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.01|-2.00|<0.001
74064997|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.051|TWO_SIDED|95.0|-0.99|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.00|-0.99|0.051
74064998|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.75|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.24|-0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.25|-1.24|0.003
74064999|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.12|-1.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-1.07|-2.12|<0.001
74065000|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-0.85|-1.90|<0.001
74065001|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.42|-0.37||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.37|-1.42|<0.001
74065002|NCT00830063|147682229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.27||0.012|TWO_SIDED|95.0|-1.19|-0.15||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.15|-1.19|0.012
74065003|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
74065004|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
74065005|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
74065006|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
74065007|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.45|-0.52||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.52|-1.45|<0.001
74065008|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.02|-1.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.10|-2.02|<0.001
73882960|NCT02201524|147299775|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|-4.9|54.9||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||54.9|-4.9|
74065009|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.361|TWO_SIDED|95.0|-0.68|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.68|0.361
74065010|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.25|-0.33||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.33|-1.25|<0.001
74065011|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.54|-0.59||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.59|-1.54|<0.001
74065012|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.04|-1.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.09|-2.04|<0.001
74065013|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.24||0.063|TWO_SIDED|95.0|-0.93|0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.02|-0.93|0.063
74065014|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.43|-0.48||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.48|-1.43|<0.001
74065015|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.7|-0.71||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.71|-1.70|<0.001
74065016|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.35|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.85|-0.86||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.86|-1.85|<0.001
74065017|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25||0.006|TWO_SIDED|95.0|-1.19|-0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.21|-1.19|0.006
73882961|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|13.3|||||TWO_SIDED|90.0|-4.4|33.8||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||33.8|-4.4|
74065018|NCT00830063|147682230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.34|-0.36||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.36|-1.34|<0.001
73882962|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-5.2|32.0||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||32.0|-5.2|
73882963|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
74065019|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
74065020|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
74065021|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
74065022|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
74065023|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.65|-0.7||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.70|-1.65|<0.001
74065024|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-1.13|-2.07|<0.001
74065025|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.24||0.274|TWO_SIDED|95.0|-0.73|0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.21|-0.73|0.274
74065026|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.22|-1.16|0.004
74065027|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.74|-0.75||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.75|-1.74|<0.001
74065028|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.0|-1.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.01|-2.00|<0.001
74065029|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.051|TWO_SIDED|95.0|-0.99|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.00|-0.99|0.051
74065030|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.24|-0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.25|-1.24|0.003
74065031|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||-1.59|-1.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.12|-1.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.07|-2.12|<0.001
74065032|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.85|-1.90|<0.001
74065033|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.42|-0.37||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.37|-1.42|<0.001
74065034|NCT00830063|147682231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.27||0.012|TWO_SIDED|95.0|-1.19|-0.15||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.15|-1.19|0.012
74065035|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.23||0.026|TWO_SIDED|95.0|-0.96|-0.06||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.06|-0.96|0.026
74065036|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.32|-0.43||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.43|-1.32|<0.001
74065037|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.23||0.333|TWO_SIDED|95.0|-0.23|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.23|0.333
74065038|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.527|TWO_SIDED|95.0|-0.59|0.3||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.30|-0.59|0.527
74065039|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.48|-0.57||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.57|-1.48|<0.001
74065040|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.16|-1.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.25|-2.16|<0.001
74065041|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.23||0.574|TWO_SIDED|95.0|-0.58|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|-0.58|0.574
74065042|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.26|-0.36||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.36|-1.26|<0.001
74065043|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.6|-0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.67|-1.60|<0.001
73882964|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|21.4|||||TWO_SIDED|90.0|-3.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||45.5|-3.2|
73882965|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|15.9|||||TWO_SIDED|90.0|-8.1|40.7||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||40.7|-8.1|
73882966|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|34.5|||||TWO_SIDED|90.0|7.3|59.4||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||59.4|7.3|
74065044|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.1|-1.17||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.17|-2.10|<0.001
74065045|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.24||0.055|TWO_SIDED|95.0|-0.92|0.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.01|-0.92|0.055
74065046|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.42|-0.49||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.49|-1.42|<0.001
74065047|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.75|-0.79||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.79|-1.75|<0.001
74065048|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.47|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.95|-0.99||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.99|-1.95|<0.001
74065049|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.24||0.006|TWO_SIDED|95.0|-1.15|-0.19||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.19|-1.15|0.006
74065050|NCT00830063|147682232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.34|-0.39||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.39|-1.34|<0.001
74065051|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.045|TWO_SIDED|95.0|-0.32|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.00|-0.32|0.045
74065052|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED|95.0|-0.33|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.33|0.030
74065053|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|0.02|0.34||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.34|0.02|0.027
74065054|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.04|TWO_SIDED|95.0|0.01|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|0.01|0.040
74065055|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.66|-0.35||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.35|-0.66|<0.001
73882967|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-11.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||45.5|-11.2|
74065056|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.72|-0.41||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.41|-0.72|<0.001
74065057|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.041|TWO_SIDED|95.0|-0.32|-0.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.01|-0.32|0.041
74065058|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.38|-0.06||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.06|-0.38|0.006
73882968|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|31.3|||||TWO_SIDED|90.0|1.7|55.7||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.7|1.7|
73882969|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|30.1|||||TWO_SIDED|90.0|-1.2|57.4|||Difference in Percentage Analysed using|||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||57.4|-1.2|
73882970|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|-6.4|52.5||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||52.5|-6.4|
73882971|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|8.7|66.7||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||66.7|8.7|
74065059|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.27||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.27|-0.60|<0.001
74065060|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.62|-0.29||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.29|-0.62|<0.001
74065061|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.011|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-0.38|0.011
74065062|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.4|-0.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.07|-0.40|0.006
74065063|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.26||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.26|-0.60|<0.001
74065064|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.14||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-0.14|-0.48|<0.001
74065065|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.42|-0.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.09|-0.42|0.003
74065066|NCT00830063|147682233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.105|TWO_SIDED|95.0|-0.3|0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.03|-0.30|0.105
74065067|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.045|TWO_SIDED|95.0|-0.32|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.00|-0.32|0.045
74065068|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED|95.0|-0.33|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.33|0.030
74065069|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|0.02|0.34||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.34|0.02|0.027
73882972|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|53.3|||||TWO_SIDED|90.0|18.5|76.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||76.6|18.5|
74065070|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.04|TWO_SIDED|95.0|0.01|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|0.01|0.040
74065071|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.64|-0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.32|-0.64|<0.001
74065072|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.74|-0.42||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.42|-0.74|<0.001
74065073|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.094|TWO_SIDED|95.0|-0.3|0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.02|-0.30|0.094
74065074|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.4|-0.08||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.08|-0.40|0.003
74065075|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.23||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.23|-0.57|<0.001
74065076|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.68|-0.35||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.35|-0.68|<0.001
74065077|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.35|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.35|0.032
74065078|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.46|-0.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.13|-0.46|<0.001
74065079|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.54|-0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.21|-0.54|<0.001
74065080|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.52|-0.19||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.19|-0.52|<0.001
74065081|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-0.38|0.012
74065082|NCT00830063|147682234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.36|-0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.03|-0.36|0.021
73882973|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|6.1|||||TWO_SIDED|90.0|-26.1|36.6||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||36.6|-26.1|
73882974|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|14.4|||||TWO_SIDED|90.0|-18.9|44.5||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||44.5|-18.9|
73882975|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|50.5|||||TWO_SIDED|90.0|12.9|75.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||75.3|12.9|
74065083|NCT00775983|147682265|NON_INFERIORITY_OR_EQUIVALENCE|Power: We assumed a standard deviation of five minutes based on historical clinic data for surgical abortions during this gestational duration range, a non-inferiority margin of five minutes, and a 10% potential attrition rate to power the study for a non-inferiority hypothesis. Thirty participants in each arm gave us 95% power to conclude non-inferiority of same day Dilapan-S compared to overnight laminaria with respect to procedure time of surgical abortions between 14-18 weeks gestation.|Mean Difference (Final Values)|2.1|||||TWO_SIDED|97.5|-0.3|4.5|||t-test, 2 sided|||Null Hypothesis: A surgical abortion performed between 14-18 weeks gestation performed after the cervix has been prepared with same-day Dilapan-S is inferior with respect to procedure time, which is specifically outside a five minute margin of non-inferiority, when compared to procedures during the same gestational duration range performed after the cervix has been prepared overnight with laminaria.||4.5|-0.3|
74065084|NCT01314703|147682274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.85|STANDARD_ERROR_OF_MEAN|0.089|||TWO_SIDED|95.0|2.66|3.02|||ANOVA||ChloraPrep 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||3.02|2.66|
74065085|NCT01314703|147682274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.038|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|3.74|4.33|||ANOVA||ChloraPrep 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||4.33|3.74|
74065086|NCT01314703|147682274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.53|STANDARD_ERROR_OF_MEAN|0.089|||TWO_SIDED|95.0|2.36|2.7|||ANOVA||70%Isopropyl Alcohol 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||2.70|2.36|
74065087|NCT01314703|147682274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.53|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|3.24|3.82|||ANOVA||70% Isopropyl Alcohol 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||3.82|3.24|
74065088|NCT01427920|147682304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.25||||||95.0|0.04|0.46|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.||FAS||0.46|0.04|
74065089|NCT01427920|147682305|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.26||||||95.0|0.05|0.48|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.||PP||0.48|0.05|
74065090|NCT01427920|147682306|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.13||||0.659||95.0|-0.44|0.69|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline FPG as covariate.||H0: D = 0.0% against HA: D ≠ 0.0%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).||0.69|-0.44|0.659
74065091|NCT01965535|147682368|SUPERIORITY_OR_OTHER||difference in proportions|1.4|||||TWO_SIDED|95.0|-5.9|8.6|||||The 2-sided 95% confidence interval (CI) on the difference in SVR12 rates between the 2 treatment groups was constructed based on stratum-adjusted Mantel-Haenszel (MH) proportions.|A sample size of 75 subjects in each treatment group would provide 80% power to detect a difference of 15% in SVR12 rates (80% vs 95%) between the 2 treatment groups.||8.6|-5.9|
74065092|NCT00919802|147682407|OTHER|||||||0.688|||||||t-test, 2 sided|||Global Response Assessment (GRA) scores were obtained 6 and 24 hours post oxytocin or saline administration.||||0.688
74065093|NCT00919802|147682408|OTHER|paired t-test comparison of change in VAR from baseline 6 hours after drug; a change in VAR score was calculated for each subject for each arm and compared using a paired t-test||||||0.7252|||||||t-test, 2 sided|||||||0.7252
74065094|NCT01946282|147682409|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.59|||||||Chi-squared|||||||0.59
74065095|NCT01946282|147682409|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.75|||||||Chi-squared|||||||.75
74065096|NCT01946282|147682409|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.08|||||||Chi-squared|||||||.080
74065097|NCT01946282|147682410|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.07|||||||Chi-squared|||||||0.070
74065098|NCT01946282|147682410|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.8|||||||Chi-squared|||||||0.80
74065099|NCT01946282|147682410|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.6|||||||Chi-squared|||||||0.60
74065100|NCT01946282|147682410|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.31|||||||Chi-squared|||||||0.31
74065101|NCT01946282|147682410|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.82|||||||Chi-squared|||||||0.82
73882976|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|9.1|||||TWO_SIDED|90.0|-25.2|41.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||41.4|-25.2|
73882977|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|3.6|||||TWO_SIDED|90.0|-30.5|37.3||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||37.3|-30.5|
73882978|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|13.6|||||TWO_SIDED|90.0|-21.9|46.2||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||46.2|-21.9|
74065102|NCT01946282|147682410|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.033|||||||Chi-squared|||||||0.033
73882979|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|2.3|||||TWO_SIDED|90.0|-33.2|34.6||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||34.6|-33.2|
73882980|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|20.5|||||TWO_SIDED|90.0|-17.6|51.9||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||51.9|-17.6|
73882981|NCT02201524|147299776|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-26.4|48.1||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||48.1|-26.4|
73882982|NCT01018030|147299812|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.386||||0.008|TWO_SIDED|95.0|-0.67|-0.1|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.|||-0.10|-0.67|0.008
73882983|NCT01018030|147299812|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.357||||0.014|TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.|||-0.07|-0.64|0.014
74065103|NCT01946282|147682410|EQUIVALENCE|We estimated needing 545 observations per incentive group to achieve power necessary to detect at least a 10% absolute difference in FIT return rate between patients who received the $5 incentive versus patients who received the $10 incentive, with assumed rates of 45% in the $5 incentive group and 53% in the $10 incentive group, a=0.05, and power=90%.||||||0.033|||||||Chi-squared|||||||0.033
74065104|NCT01946282|147682410|EQUIVALENCE||||||>|0.99|||||||Chi-squared|||||||>0.99
74065105|NCT01946282|147682410|EQUIVALENCE|||||||0.184|||||||Chi-squared|||||||0.184
74065106|NCT01493531|147682411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.23|0.41|||Cochran-Mantel-Haenszel|||||0.41|0.23|<0.0001
74065107|NCT01493531|147682411|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.34|0.52|||Cochran-Mantel-Haenszel|||||0.52|0.34|<0.0001
74065108|NCT01493531|147682412|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.5716|TWO_SIDED|95.0|0.57|1.37|||Negative Binomial Regression|||||1.37|0.57|0.5716
74065109|NCT01493531|147682412|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.7454|TWO_SIDED|95.0|0.6|1.45|||Negative Binomial Regression|||||1.45|0.60|0.7454
74065110|NCT01493531|147682413|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.8466|TWO_SIDED|95.0|-0.24|0.2|||Cochran-Mantel-Haenszel|||||0.2|-0.24|0.8466
74065111|NCT01493531|147682413|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.06||||0.6301|TWO_SIDED|95.0|-0.29|0.17|||Cochran-Mantel-Haenszel|||||0.17|-0.29|0.6301
74065112|NCT02059187|147682431|NON_INFERIORITY_OR_EQUIVALENCE|MK-1293 was to be considered non-inferior to Lantus in type 2 diabetes mellitus (T2DM) if the upper bound of the two-sided 95% confidence interval (CI) for the between-treatment difference (MK-1293 minus Lantus) in least-squares (LS) means was below 0.4% based on a cLDA model.|Difference in least squares means|0.03|||||TWO_SIDED|95.0|-0.12|0.18||||||||0.18|-0.12|
74065113|NCT02059187|147682432|SUPERIORITY_OR_OTHER||Difference in percentage|5.7|||||TWO_SIDED|95.0|-2.3|13.7||||||||13.7|-2.3|
74065114|NCT02059187|147682434|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-8.5|8.5||||||||8.5|-8.5|
73882984|NCT00189540|147299829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0|||||ANCOVA|||Comparison made is the difference from baseline at Month 3.||||0.35
74065115|NCT02059187|147682435|SUPERIORITY_OR_OTHER||Difference in percent|6.8|||||TWO_SIDED|95.0|-0.6|14.2||||||||14.2|-0.6|
74065116|NCT02059187|147682436|SUPERIORITY_OR_OTHER||Difference in LS means|1.4|||||TWO_SIDED|95.0|-2.2|4.9||||||||4.9|-2.2|
74065117|NCT02059187|147682437|SUPERIORITY_OR_OTHER||Dofference in LS means|0.01|||||TWO_SIDED|95.0|-0.02|0.05||||||||0.05|-0.02|
74065118|NCT02059187|147682438|SUPERIORITY_OR_OTHER||Difference in LS means|3.5|||||TWO_SIDED|95.0|-3.7|10.7||||||||10.7|-3.7|
74065119|NCT02059187|147682439|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.4|||||TWO_SIDED|95.0|-11.3|4.4||||||||4.4|-11.3|
74065120|NCT02059187|147682440|SUPERIORITY_OR_OTHER||Adjusted difference in percent|2.8|||||TWO_SIDED|95.0|-6.1|11.6|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.|||11.6|-6.1|
74065121|NCT02059187|147682441|SUPERIORITY_OR_OTHER||Adjusted difference in percent|-0.9|||||TWO_SIDED|95.0|-8.3|6.5|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.|||6.5|-8.3|
74065122|NCT03070431|147682442|SUPERIORITY|It was assumed that radiotherapy with 5x4 Gy results in 6-month LPFS of 67% and an increase by 20% is clinically relevant when using 5x5 Gy. For comparison of 5x5 Gy and a historical control (5x4 Gy), it was assumed that it can be performed with a simple Pearson-Chi-Square test (2-sided significance level of 5%, power of 79%) if 40 patients treated with 5x5 Gy and 400 patients of the control group qualified for Propensity-Score adjusted comparison, assuming 6-month LPFS rates of 87% and 67%.|Risk Difference (RD)|20.0|||<|0.05|TWO_SIDED||||||Cochran-Mantel-Haenszel|||historical control group treated with 5 x 4 Gy|"In a prospective study, 6-month LPFS rates were 86% after longer-course (mainly 3Gyx10) and 67% after short-course radiotherapy (mainly 4Gyx5) \[Rades D, et al., Int J Radiat Oncol Biol Phys 2009;73:228-34.\]. For sample size calculations, it was assumed that conventional radiotherapy with 4Gyx5 results in 6-month LPFS of 67% and that an increase by 20% is clinically relevant and realistic with 5Gyx5. A sample size of 40 eligible patients was required for the phase 2 trial assuming that that 6-month LPFS would be 87% and estimated with a precision of +/-20% expressed as the half length of the associated two-sided confidence interval (95%), and power of \>=80%.~For comparison of phase 2 cohort and historical control group, it was assumed that this could be performed with a simple Pearson-Chi-Square test using a two-sided significance level of 5% (10%) and a power of 79% (86%) if 40 patients received 5Gyx5 and N=400 of the control group qualified for Propensity-Score adjusted comparison."|||<0.05
74065123|NCT01889862|147682452|SUPERIORITY||Mean Difference (Net)|-973.02|||<|0.0001|TWO_SIDED|95.0|-1204.19|-741.85||Based on Mixed-Effect Model Repeated Measure (MMRM) model with change from baseline as the response variable, and treatment, visit and treatment by visit interaction and baseline blood phe concentration as factors.|ANCOVA|||Change in blood Phe concentration during Part 2 in subjects previously exposed to BMN165 who self administer BMN165 20mg/day compared with those who self administer matching placebo.||-741.85|-1204.19|<0.0001
74065124|NCT01889862|147682452|SUPERIORITY||Mean Difference (Net)|-588.5|||<|0.0001|TWO_SIDED|95.0|-830.07|-346.94||Based on Mixed-Effect Model Repeated Measure (MMRM) model with change from baseline as the response variable, and treatment, visit and treatment by visit interaction and baseline blood phe concentration as factors.|ANCOVA|||Change in blood Phe concentration during Part 2 in subjects previously exposed to BMN165 who self administer BMN165 40mg/day compared with those who self administer matching placebo.||-346.94|-830.07|<0.0001
74065125|NCT00845026|147682458|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||95.0||||No adjustments were made for multiplicity. All treatment comparisons were evaluated based on a two-sided significance level of 0.05.|Log Rank|||||||0.184
74065126|NCT02065791|147682498|SUPERIORITY||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.59|0.82|||Cox Proportional Hazard|||Comparison for canagliflozin versus placebo is reported here.||0.82|0.59|< 0.0001
74065127|NCT02065791|147682499|SUPERIORITY||Hazard Ratio (HR)|0.69|||=|0.0001|TWO_SIDED|95.0|0.57|0.83|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||0.83|0.57|=0.0001
74065128|NCT02065791|147682500|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.0121|TWO_SIDED|95.0|0.67|0.95|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||0.95|0.67|=0.0121
74065129|NCT02065791|147682501|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.0003|TWO_SIDED|95.0|0.47|0.8|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.80|0.47|=0.0003
74065130|NCT02065791|147682502|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.53|0.81|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.81|0.53|<0.0001
74065131|NCT02065791|147682503|SUPERIORITY||Hazard Ratio (HR)|0.78|||=|0.0502|TWO_SIDED|95.0|0.61|1.0|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||1.00|0.61|=0.0502
74065132|NCT02065791|147682504|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.0727|TWO_SIDED|95.0|0.68|1.02|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||1.02|0.68|= 0.0727
74065133|NCT02065791|147682505|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0001|TWO_SIDED|95.0|0.63|0.86|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.86|0.63|0.0001
74065134|NCT00272961|147682506|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|8.37|STANDARD_ERROR_OF_MEAN|6.19||0.185|TWO_SIDED|95.0|-4.21|20.96|||ANCOVA|||Sitting SBP: p-value was obtained using an Analysis of Co-variance (ANCOVA) model on the maximum increase observed with baseline value as a covariate.||20.96|-4.21|0.185
74065135|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|5.59||0.97|TWO_SIDED|95.0|-11.16|11.59|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.59|-11.16|0.970
74065136|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|5.71||0.994|TWO_SIDED|95.0|-11.66|11.57|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.57|-11.66|0.994
74065137|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|5.72||0.861|TWO_SIDED|95.0|-10.62|12.64|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||12.64|-10.62|0.861
74065138|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|4.9||0.221|TWO_SIDED|95.0|-3.79|15.99|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||15.99|-3.79|0.221
74065139|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|4.49||0.88|TWO_SIDED|95.0|-8.37|9.73|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||9.73|-8.37|0.880
74065140|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|4.56||0.9|TWO_SIDED|95.0|-9.78|8.63|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||8.63|-9.78|0.900
74065141|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.71|STANDARD_ERROR_OF_MEAN|4.56||0.218|TWO_SIDED|95.0|-14.91|3.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||3.50|-14.91|0.218
74065142|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|5.62|STANDARD_ERROR_OF_MEAN|2.68||0.044|TWO_SIDED|95.0|0.17|11.08|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.08|0.17|0.044
74065143|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|2.41||0.557|TWO_SIDED|95.0|-3.47|6.33|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.33|-3.47|0.557
74065144|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|6.37|STANDARD_ERROR_OF_MEAN|2.5||0.016|TWO_SIDED|95.0|1.28|11.45|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.45|1.28|0.016
74065145|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|2.5||0.695|TWO_SIDED|95.0|-4.09|6.07|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.07|-4.09|0.695
74065146|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|2.56||0.067|TWO_SIDED|95.0|-0.36|9.95|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||9.95|-0.36|0.067
74065147|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|2.36||0.737|TWO_SIDED|95.0|-3.96|5.55|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||5.55|-3.96|0.737
73882985|NCT00189540|147299829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||ANCOVA|||Comparison made is the difference from baseline at Month 6.||||0.17
73882986|NCT00189540|147299830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||Fisher Exact|||The comparison of groups at Month 3||||0.55
73882987|NCT00189540|147299830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0|||||Fisher Exact|||The comparison of groups at Month 6.||||0.28
73882988|NCT00189540|147299831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||ANCOVA|||Comparison between groups at Month 3||||0.2
73882989|NCT00189540|147299831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0|||||ANCOVA|||Comparison between groups at Month 6||||0.04
73882990|NCT00189540|147299832|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.00
73882991|NCT00189540|147299833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||95.0|||||ANCOVA|||Comparison at Month 3||||0.77
73882992|NCT00189540|147299833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45||95.0|||||ANCOVA|||Comparison at Month 6||||0.45
73882993|NCT00189540|147299834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||ANCOVA|||Comparison between groups for mean TBI at Month 3 versus baseline.||||0.06
73882994|NCT00189540|147299834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANCOVA|||Comparison between groups for mean TBI at Month 6 versus baseline.||||0.05
73882995|NCT02546609|147299855|OTHER|||||||0.0572|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.||||0.0572
73882996|NCT02546609|147299855|OTHER|||||||0.377|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.||||0.3770
73882997|NCT02546609|147299856|OTHER|||||||0.3811|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3811
73882998|NCT02546609|147299856|OTHER|||||||0.8479|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8479
74065148|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|STANDARD_ERROR_OF_MEAN|2.4||0.023|TWO_SIDED|95.0|0.8|10.47|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||10.47|0.80|0.023
74065149|NCT00272961|147682506|SUPERIORITY_OR_OTHER||LS Mean Difference|1.65|STANDARD_ERROR_OF_MEAN|2.4||0.495|TWO_SIDED|95.0|-3.2|6.5|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.50|-3.20|0.495
74065150|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|232.59|STANDARD_ERROR_OF_MEAN|201.83||0.2577|TWO_SIDED|95.0|-178.5|643.7|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||643.7|-178.5|0.2577
74065151|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|103.67|STANDARD_ERROR_OF_MEAN|173.86||0.5552|TWO_SIDED|95.0|-250.5|457.8|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||457.8|-250.5|0.5552
74065152|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|41.26|STANDARD_ERROR_OF_MEAN|177.26||0.8174|TWO_SIDED|95.0|-319.8|402.3|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||402.3|-319.8|0.8174
74065153|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|166.4|STANDARD_ERROR_OF_MEAN|177.55||0.3557|TWO_SIDED|95.0|-195.3|528.1|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||528.1|-195.3|0.3557
74065154|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|163.04|STANDARD_ERROR_OF_MEAN|130.15||0.2172|TWO_SIDED|95.0|-99.6|425.7|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||425.7|-99.6|0.2172
73882999|NCT02546609|147299857|OTHER|||||||0.7742|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.7742
74065155|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|115.35|STANDARD_ERROR_OF_MEAN|116.03||0.3258|TWO_SIDED|95.0|-118.8|349.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||349.5|-118.8|0.3258
74065156|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|24.67|STANDARD_ERROR_OF_MEAN|117.88||0.8352|TWO_SIDED|95.0|-213.2|262.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||262.6|-213.2|0.8352
74065157|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|50.59|STANDARD_ERROR_OF_MEAN|117.93||0.6701|TWO_SIDED|95.0|-187.4|288.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||288.6|-187.4|0.6701
74065158|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|225.57|STANDARD_ERROR_OF_MEAN|108.95||0.0466|TWO_SIDED|95.0|3.6|447.5|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||447.5|3.6|0.0466
74065159|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|114.77|STANDARD_ERROR_OF_MEAN|93.2637||0.2274|TWO_SIDED|95.0|-75.2|304.8|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||304.8|-75.2|0.2274
74065160|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|224.89|STANDARD_ERROR_OF_MEAN|96.9259||0.0269|TWO_SIDED|95.0|27.5|422.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||422.3|27.5|0.0269
73883000|NCT02546609|147299857|OTHER|||||||0.6666|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6666
73883001|NCT02546609|147299858|OTHER|||||||0.002|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0020
73883002|NCT02546609|147299858|OTHER|||||||0.0164|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0164
74065161|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|133.22|STANDARD_ERROR_OF_MEAN|96.7383||0.178|TWO_SIDED|95.0|-63.8|330.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||330.3|-63.8|0.1780
74065162|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|240.64|STANDARD_ERROR_OF_MEAN|114.32||0.0413|TWO_SIDED|95.0|9.9|471.4|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||471.4|9.9|0.0413
74065163|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|157.99|STANDARD_ERROR_OF_MEAN|102.21||0.1297|TWO_SIDED|95.0|-48.3|364.3|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||364.3|-48.3|0.1297
74065164|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|254.9|STANDARD_ERROR_OF_MEAN|104.0||0.0185|TWO_SIDED|95.0|45.0|464.8|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||464.8|45.0|0.0185
74065165|NCT00272961|147682507|SUPERIORITY_OR_OTHER||LS Mean Difference|157.66|STANDARD_ERROR_OF_MEAN|104.33||0.1382|TWO_SIDED|95.0|-52.9|368.2|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||368.2|-52.9|0.1382
74065166|NCT00272961|147682512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|3.0||0.7758|TWO_SIDED|95.0|-5.31|7.03|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||7.03|-5.31|0.7758
74065167|NCT00272961|147682512|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|2.45||0.888|TWO_SIDED|95.0|-5.4|4.71|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||4.71|-5.40|0.8880
74065168|NCT00272961|147682512|SUPERIORITY_OR_OTHER||LS Mean Difference|1.86|STANDARD_ERROR_OF_MEAN|2.46||0.4573|TWO_SIDED|95.0|-3.21|6.93|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||6.93|-3.21|0.4573
74065169|NCT00272961|147682512|SUPERIORITY_OR_OTHER||LS Mean Difference|2.17|STANDARD_ERROR_OF_MEAN|2.78||0.4424|TWO_SIDED|95.0|-3.56|7.91|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||7.91|-3.56|0.4424
74065170|NCT00272961|147682512|SUPERIORITY_OR_OTHER||LS Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|3.32||0.347|TWO_SIDED|95.0|-3.65|10.01|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||10.01|-3.65|0.3470
74065171|NCT00272961|147682512|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|2.72||0.6249|TWO_SIDED|95.0|-4.25|6.94|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||6.94|-4.25|0.6249
74065172|NCT00272961|147682512|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|2.73||0.1625|TWO_SIDED|95.0|-1.69|9.54|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||9.54|-1.69|0.1625
74065173|NCT00272961|147682512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|3.08||0.7556|TWO_SIDED|95.0|-5.38|7.31|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||7.31|-5.38|0.7556
74065174|NCT00272961|147682513|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.99|STANDARD_ERROR_OF_MEAN|1.59||0.0714|TWO_SIDED|95.0|-6.25|0.28|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||0.28|-6.25|0.0714
74065175|NCT00272961|147682513|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.34||0.7269|TWO_SIDED|95.0|-2.29|3.24|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||3.24|-2.29|0.7269
74065176|NCT00272961|147682513|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|1.36||0.8656|TWO_SIDED|95.0|-2.58|3.04|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||3.04|-2.58|0.8656
73883003|NCT02546609|147299859|OTHER|||||||0.4099|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4099
73883004|NCT02546609|147299859|OTHER|||||||0.1455|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.1455
74065177|NCT00272961|147682513|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|1.4||0.7113|TWO_SIDED|95.0|-3.41|2.36|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||2.36|-3.41|0.7113
73883005|NCT02546609|147299860|OTHER|||||||0.2559|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.2559
73883006|NCT02546609|147299860|OTHER|||||||0.9776|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.9776
73883007|NCT02546609|147299861|OTHER|||||||0.2265|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.2265
73883008|NCT02546609|147299861|OTHER|||||||0.8366|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8366
74065178|NCT00272961|147682513|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|2.21||0.2204|TWO_SIDED|95.0|-7.32|1.77|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.77|-7.32|0.2204
74065179|NCT00272961|147682513|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|1.87||0.5298|TWO_SIDED|95.0|-5.04|2.66|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||2.66|-5.04|0.5298
74065180|NCT00272961|147682513|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|1.9||0.3135|TWO_SIDED|95.0|-5.86|1.96|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.96|-5.86|0.3135
74065181|NCT00272961|147682513|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|1.95||0.2962|TWO_SIDED|95.0|-6.09|1.93|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.93|-6.09|0.2962
74065182|NCT00272961|147682514|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.74|STANDARD_ERROR_OF_MEAN|5.39||0.4933|TWO_SIDED|95.0|-14.84|7.35|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||7.35|-14.84|0.4933
74065183|NCT00272961|147682514|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|4.57||0.408|TWO_SIDED|95.0|-13.26|5.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||5.57|-13.26|0.4080
74065184|NCT00272961|147682514|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|4.56||0.5936|TWO_SIDED|95.0|-11.86|6.93|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.93|-11.86|0.5936
74065185|NCT00272961|147682514|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|4.79||0.7883|TWO_SIDED|95.0|-11.17|8.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||8.57|-11.17|0.7883
74065186|NCT00272961|147682514|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|5.12||0.5719|TWO_SIDED|95.0|-13.46|7.6|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||7.60|-13.46|0.5719
74065187|NCT00272961|147682514|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|4.33||0.3401|TWO_SIDED|95.0|-13.11|4.7|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||4.70|-13.11|0.3401
74065188|NCT00272961|147682514|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.34||0.6329|TWO_SIDED|95.0|-11.01|6.82|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.82|-11.01|0.6329
74065189|NCT00272961|147682514|SUPERIORITY_OR_OTHER||LS Mean Difference|3.83|STANDARD_ERROR_OF_MEAN|4.51||0.4037|TWO_SIDED|95.0|-5.45|13.11|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||13.11|-5.45|0.4037
74065190|NCT00272961|147682515|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|4.08||0.7685|TWO_SIDED|95.0|-7.19|9.62|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||9.62|-7.19|0.7685
74065191|NCT00272961|147682515|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.88|STANDARD_ERROR_OF_MEAN|3.49||0.1739|TWO_SIDED|95.0|-12.07|2.3|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||2.30|-12.07|0.1739
74065192|NCT00272961|147682515|SUPERIORITY_OR_OTHER||LS Mean Difference|2.71|STANDARD_ERROR_OF_MEAN|3.61||0.4612|TWO_SIDED|95.0|-4.74|10.15|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||10.15|-4.74|0.4612
74065193|NCT00272961|147682515|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|3.67||0.7172|TWO_SIDED|95.0|-8.9|6.21|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.21|-8.90|0.7172
74065194|NCT00272961|147682515|SUPERIORITY_OR_OTHER||LS Mean Difference|3.45|STANDARD_ERROR_OF_MEAN|4.12||0.4098|TWO_SIDED|95.0|-5.01|11.91|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||11.91|-5.01|0.4098
74065195|NCT00272961|147682515|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|3.48||0.6943|TWO_SIDED|95.0|-8.54|5.78|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||5.78|-8.54|0.6943
74065196|NCT00272961|147682515|SUPERIORITY_OR_OTHER||LS Mean Difference|4.78|STANDARD_ERROR_OF_MEAN|3.67||0.2042|TWO_SIDED|95.0|-2.76|12.31|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||12.31|-2.76|0.2042
74065197|NCT00272961|147682515|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|3.77||0.7791|TWO_SIDED|95.0|-6.69|8.83|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||8.83|-6.69|0.7791
73883009|NCT02546609|147299862|OTHER|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3470
74065198|NCT04428502|147682548|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.6|||||||Student's t-test|||At Month 1: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.6
74065199|NCT04428502|147682548|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.007|||||||Student's t-test|||At Month 6: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.007
74065200|NCT04428502|147682548|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.004|||||||Student's t-test|||At Month 12: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.004
74065201|NCT00449930|147682551|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus metformin) to be less than 0.4%.|Mean Difference (Net)|0.14|STANDARD_DEVIATION|0.57||||95.0|0.06|0.21|||||Based on an analysis of covariance (ANCOVA) model with terms for treatment group and baseline value.|||0.21|0.06|
74065202|NCT00449930|147682552|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.3|||<|0.001||95.0|-10.6|-4.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with diarrhea.~Wilson Score method was used for the 95% Confidence Interval (CI)."|||-4.2|-10.6|<0.001
74065203|NCT00449930|147682553|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.9||||0.032||95.0|-3.9|-0.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with nausea.~Wilson Score method was used for the 95% CI."|||-0.2|-3.9|0.032
74065204|NCT00449930|147682554|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.7||||0.103||95.0|-4.0|0.3|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with abdominal pain.~Wilson Score method was used for the 95% CI."|||0.3|-4.0|0.103
74065205|NCT00449930|147682555|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.0||||||95.0|-2.4|0.2|||||"Difference (sitagliptin minus metformin) in the percentage of patients with vomiting.~Wilson Score method was used for the 95% CI."|||0.2|-2.4|
74065206|NCT01864525|147682556|SUPERIORITY|||||||0.0216||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0216
74065207|NCT01864525|147682556|SUPERIORITY|||||||0.0499||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0499
74065208|NCT01864525|147682556|SUPERIORITY|||||||0.0339||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0339
74065209|NCT01864525|147682556|SUPERIORITY|||||||0.045||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0450
74065210|NCT01864525|147682557|SUPERIORITY|||||||0.7172||||||A priori significance was set at P\<0.05 for this hypothesis-driven auditory-perceptual variable. Main effect for drug is given above. For the main task effect, P=0.9602. For the interaction effect of drug\*task, P=0.1699.|Mixed Models Analysis|||Statistical modeling tested for main effects of auditory-perceptual ratings for drug and task (sustained vowel and sentence-level ratings), and interaction effects of these variables. The summed scores, averaged across all participants, are provided separately for the sustained vowel and sentence-level ratings. Values range from 0 (no difference between baseline and post-test) to 3 (all three raters indicated that post-test sample was better (less tremor severity).||||0.7172
74065211|NCT01890785|147682558|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.708|||||TWO_SIDED|90.0|0.655|0.766||||||||0.766|0.655|
74065212|NCT01890785|147682558|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.918|||||TWO_SIDED|90.0|0.849|0.992||||||||0.992|0.849|
74065213|NCT01890785|147682559|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.641|||||TWO_SIDED|90.0|0.582|0.707||||||||0.707|0.582|
74065214|NCT01890785|147682559|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.828|||||TWO_SIDED|90.0|0.752|0.912||||||||0.912|0.752|
74065215|NCT01890785|147682560|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.97|||||TWO_SIDED|90.0|0.937|1.004||||||||1.004|0.937|
73883010|NCT02546609|147299862|OTHER|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6221
74065216|NCT01890785|147682560|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.944|||||TWO_SIDED|90.0|0.912|0.977||||||||0.977|0.912|
74065217|NCT01890785|147682561|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.971|||||TWO_SIDED|90.0|0.945|0.998||||||||0.998|0.945|
74065218|NCT01890785|147682561|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.97|||||TWO_SIDED|90.0|0.944|0.997||||||||0.997|0.944|
74065219|NCT03001011|147682589|SUPERIORITY||Median difference (Renvela - Placebo)|-0.21|||<|0.0001|TWO_SIDED|||||Threshold for statistical significance at 0.05.|Wilcoxon rank sum test||Renvela Vs. Placebo|A hierarchical testing procedure was used to control type I error \& handle multiple secondary endpoint analyses. Testing was then performed sequentially in order outcome measures (OM) are reported. The hierarchical testing sequence continued only when previous OM was statistically significant at 0.05 level.||||<0.0001
74065220|NCT00065065|147682613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0||||0.005||95.0|1.5|10.5|||Regression, Logistic|||||10.5|1.5|.005
74065221|NCT00397839|147682616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.58|||<|0.001||95.0|1.41|3.76|||ANCOVA|||||3.76|1.41|<0.001
74065222|NCT00397839|147682617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.86||||0.118||95.0|-0.22|1.94|||ANCOVA|||||1.94|-0.22|0.118
74065223|NCT00397839|147682618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.13|||<|0.001||95.0|1.34|2.92|||ANCOVA|||Total Hip subgroup||2.92|1.34|<0.001
74065224|NCT00397839|147682618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.43||||0.012||95.0|0.32|2.55|||ANCOVA|||Femoral Neckm subgroup||2.55|0.32|0.012
73883011|NCT02546609|147299863|OTHER|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3470
73883012|NCT02546609|147299863|OTHER|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6221
73883013|NCT02546609|147299864|OTHER|||||||0.0129|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0129
73883014|NCT02546609|147299864|OTHER|||||||0.4316|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4316
74065225|NCT00397839|147682618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.72||||0.004||95.0|0.56|2.88|||ANCOVA|||Trochanter subgroup||2.88|0.56|0.004
74065226|NCT00397839|147682619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75|||<|0.001||95.0|1.11|2.4|||ANCOVA|||Total Hip subgroup||2.40|1.11|<0.001
74065227|NCT00397839|147682619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Femoral Neck subgroup||2.25|0.11|0.031
74065228|NCT00397839|147682619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Trochanter subgroup||2.25|0.11|0.031
74065229|NCT00397839|147682620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.362||95.0|0.73|1.13|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 6||1.13|0.73|0.362
74065230|NCT00397839|147682620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85||||0.044||95.0|0.72|1.01|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 12||1.01|0.72|0.044
74065231|NCT00397839|147682620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|||<|0.001||95.0|0.3|0.72|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 6||0.72|0.30|<0.001
74065232|NCT00397839|147682620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|||<|0.001||95.0|0.41|0.8|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 12||0.80|0.41|<0.001
74065233|NCT00397839|147682620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||<|0.001||95.0|0.23|0.72|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD at Month 6||0.72|0.23|<0.001
74065234|NCT00397839|147682620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||<|0.001||95.0|0.33|0.75|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD||0.75|0.33|<0.001
74065235|NCT01241565|147682621|SUPERIORITY_OR_OTHER||Rate of incidence of PAL|10.6|||||TWO_SIDED|95.0|3.9|21.3|||||Incidence of Prolonged Air Leak (PAL) is estimated at between 5-10% in literature. PAL of 10%of evaluable cases was used to determine study success.|||21.3|3.9|
74065236|NCT02713243|147682628|SUPERIORITY||Mean Difference (Net)|4.04||||0.01|TWO_SIDED|95.0|0.98|7.11|||Mixed Models Analysis|||Week 1 (Period 1 \& 2)||7.11|0.98|0.01
74065237|NCT02713243|147682628|SUPERIORITY||Mean Difference (Net)|1.31||||0.401|TWO_SIDED|95.0|-1.77|4.38|||Mixed Models Analysis|||Week 2 (Period 1 \& 2)||4.38|-1.77|0.401
74065238|NCT02713243|147682628|SUPERIORITY||Mean Difference (Net)|2.67||||0.019|TWO_SIDED|95.0|0.46|4.89|||Mixed Models Analysis|||Week 1\&2 (Period 1 \& 2)||4.89|0.46|0.019
73883015|NCT02546609|147299865|OTHER|MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||||0.1946|||||||MMRM|||||||0.1946
73883016|NCT02546609|147299865|OTHER|||||||0.4697|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4697
73883017|NCT02546609|147299866|OTHER|||||||0.3474|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3474
73883018|NCT02546609|147299866|OTHER|||||||0.8832|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8832
74065239|NCT02713243|147682633|SUPERIORITY||Mean Difference (Net)|0.12||||0.533|TWO_SIDED|95.0|-0.27|0.52|||Mixed Models Analysis|||Week 1 (Period 1 \& 2)||0.52|-0.27|0.533
74065240|NCT02713243|147682633|SUPERIORITY||Mean Difference (Net)|-0.09||||0.64|TWO_SIDED|95.0|-0.49|0.3|||Mixed Models Analysis|||Week 2 (Period 1 \& 2)||0.30|-0.49|0.640
74065241|NCT02713243|147682633|SUPERIORITY||Mean Difference (Net)|0.02||||0.916|TWO_SIDED|95.0|-0.27|0.3|||Mixed Models Analysis|||Week 1\&2 (Period 1 \& 2)||0.30|-0.27|0.916
74065242|NCT02795780|147682654|OTHER|||||||0.0166||||||No adjustments for multiplicity. No a priori threshold defined.|ANCOVA|Adjusted for baseline SUVr, age, and diagnosis group (AD/MCI)||Test of whether difference in least squares mean change is 0||||0.0166
74065243|NCT02795780|147682654|OTHER|||||||0.0108||||||No adjustments for multiplicity. No a priori threshold defined.|ANCOVA|Adjusted for baseline SUVr, age, and diagnosis group (AD/MCI)||Test of whether difference in least squares mean change is 0||||0.0108
74065244|NCT00530439|147682705|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.014
74065245|NCT01529749|147682706|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065246|NCT01529749|147682707|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065247|NCT01529749|147682708|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065248|NCT01529749|147682709|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065249|NCT01529749|147682710|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
73883019|NCT01292486|147299886|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 2 days.|Median Difference (Final Values)|0.0|||<|0.025|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehman estimation|||The null hypothesis was that the median day to neutrophil recovery in this study was more than two days longer than historical controls.||0.0|0.0|<0.025
74065250|NCT01529749|147682711|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
73883020|NCT01553084|147299896|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3623|TWO_SIDED|95.0|0.8|1.7|||Regression, Logistic|||Combination NRT will be compared statististically versus Nicotine patch only (the reference or control group).||1.7|0.8|.3623
73883021|NCT01553084|147299896|SUPERIORITY||Odds Ratio (OR)|0.9||||0.1947|TWO_SIDED|95.0|0.6|1.2|||Regression, Logistic|||Varenicline will be compared statististically versus Nicotine patch only (the reference or control group).||1.2|0.6|.1947
74065251|NCT01529749|147682712|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065252|NCT01529749|147682713|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065253|NCT01529749|147682714|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
74065254|NCT01529749|147682715|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065255|NCT01529749|147682716|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065256|NCT01529749|147682717|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065257|NCT01529749|147682718|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065258|NCT01529749|147682719|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065259|NCT01529749|147682720|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
74065260|NCT01529749|147682721|SUPERIORITY|||||||0.49|||||||Chi-squared, Corrected|||||||0.49
74065261|NCT01529749|147682722|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
74065262|NCT01681771|147682742|SUPERIORITY|||||||0.21|||||||ANCOVA|ANCOVA analysis comparing PHQ-9 mean values at 9 weeks follow-up between the I-CBT and discussion group and adjusting for PHQ-9 values baseline||||||0.21
74065263|NCT03154333|147682743|OTHER||Risk Ratio (RR)|1.01||||0.9666|TWO_SIDED|95.0|0.63|1.62|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.||||1.62|0.63|0.9666
74065264|NCT03154333|147682744|OTHER||Risk Ratio (RR)|1.53||||0.2861|TWO_SIDED|95.0|0.41|3.28|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.||||3.28|0.41|0.2861
74065265|NCT02919475|147682767|SUPERIORITY|||||||0.842|||||||Fisher Exact|||||||0.842
74065266|NCT02919475|147682767|SUPERIORITY|||||||0.841|||||||Fisher Exact|||||||0.841
74065267|NCT02919475|147682767|SUPERIORITY|||||||0.842|||||||Fisher Exact|||||||0.842
74065268|NCT02919475|147682767|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
74065269|NCT02919475|147682768|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
74065270|NCT02919475|147682768|SUPERIORITY|||||||0.832|||||||Fisher Exact|||||||0.832
74065271|NCT02919475|147682768|SUPERIORITY|||||||0.682|||||||Fisher Exact|||||||0.682
74065272|NCT02919475|147682768|SUPERIORITY|||||||0.665|||||||Fisher Exact|||||||0.665
74065273|NCT02919475|147682769|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
74065274|NCT02919475|147682769|SUPERIORITY|||||||0.627|||||||Fisher Exact|||||||0.627
74065275|NCT02919475|147682769|SUPERIORITY|||||||0.794|||||||Fisher Exact|||||||0.794
74065276|NCT02919475|147682769|SUPERIORITY|||||||0.453|||||||Fisher Exact|||||||0.453
74065277|NCT02919475|147682770|SUPERIORITY|||||||0.113|||||||Fisher Exact|||||||0.113
74065278|NCT02919475|147682770|SUPERIORITY|||||||0.024|||||||Fisher Exact|||||||0.024
74065279|NCT02919475|147682770|SUPERIORITY|||||||0.056|||||||Fisher Exact|||||||0.056
74065280|NCT02919475|147682770|SUPERIORITY|||||||0.035|||||||Fisher Exact|||||||0.035
74065281|NCT01663714|147682789|SUPERIORITY_OR_OTHER||percentage of participants|100.0|||||TWO_SIDED|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with unconfirmed response.|||100|100|
74065282|NCT01663714|147682790|SUPERIORITY_OR_OTHER||percentage of participants|100.0|||||TWO_SIDED|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with confirmed response.|||100|100|
74065283|NCT00597584|147682811|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.078|||TWO_SIDED|95.0|-0.05|0.26|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study has been determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.||0.26|-0.05|
74065284|NCT00597584|147682812|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.5|1.24|||Cochran-Mantel-Haenszel|||||1.24|0.50|
74065285|NCT00597584|147682813|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.87|1.07|||Cochran-Mantel-Haenszel|||||1.07|0.87|
73883022|NCT01553084|147299897|SUPERIORITY||Hazard Ratio (HR)|0.915||||0.3613|TWO_SIDED|95.0|0.756|1.107|||Regression, Cox|||||1.107|.756|.3613
73883023|NCT01553084|147299897|SUPERIORITY||Hazard Ratio (HR)|0.943||||0.5503|TWO_SIDED|95.0|0.779|1.142|||Regression, Cox|||||1.142|.779|.5503
74065286|NCT01294592|147682827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.8|-1.7||Month 1|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.7|-2.8|<0.001
74065287|NCT01294592|147682827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.7|-1.5||Month 3|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.5|-2.7|<0.001
74065288|NCT01294592|147682827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.1|-0.9||Month 6|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-0.9|-2.1|<0.001
74065289|NCT01294592|147682827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.2|-1.0||Month 9|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.2|<0.001
73883024|NCT01553084|147299898|SUPERIORITY||Odds Ratio (OR)|1.5||||0.03|TWO_SIDED|95.0|1.1|2.2|||Regression, Logistic|||||2.2|1.1|.03
73883025|NCT01553084|147299898|SUPERIORITY||Odds Ratio (OR)|0.8||||0.19|TWO_SIDED|95.0|0.6|1.1|||Regression, Logistic|||||1.1|0.6|.19
74065290|NCT01294592|147682827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-2.2|-1.0||Month 12|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.2|<0.001
74065291|NCT01294592|147682827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.3|-1.0||Month 15|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.3|<0.001
73883026|NCT01553084|147299899|SUPERIORITY||Mean Difference (Final Values)|-0.00612|STANDARD_ERROR_OF_MEAN|0.00625||0.3282|TWO_SIDED||||||t-test, 2 sided|df=710||||||.3282
73883027|NCT03988400|147299900|SUPERIORITY|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1
74065292|NCT01294592|147682827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.35|<|0.001|TWO_SIDED|95.0|-2.4|-1.0||Month 18|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.4|<0.001
74065293|NCT01294592|147682827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.5|-1.2||Month 21|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.2|-2.5|<0.001
74065294|NCT01294592|147682827|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.5|-1.2||Month 24|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.2|-2.5|<0.001
74065295|NCT00623623|147682847|OTHER||Relative risk|0.86||||0.195|TWO_SIDED|95.0|0.68|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.08|0.68|0.195
74065296|NCT00623623|147682848|OTHER||Relative risk|1.03||||0.904|TWO_SIDED|95.0|0.68|1.55|||modified Poisson regression|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.55|0.68|0.904
73883028|NCT03988400|147299901|SUPERIORITY|||||||0.017||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||0.017
73883029|NCT03988400|147299902|SUPERIORITY|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1
73883030|NCT03988400|147299903|SUPERIORITY|||||||0.72||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.72
73883031|NCT03988400|147299904|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.001
73883032|NCT03988400|147299905|SUPERIORITY|||||||0.68||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||0.68
73883033|NCT03988400|147299906|SUPERIORITY|||||||0.25||||||The a priori threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.25
73883034|NCT03988400|147299907|SUPERIORITY|||||||0.69||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.69
74065297|NCT00623623|147682849|OTHER||Relative risk|0.97||||0.905|TWO_SIDED|95.0|0.6|1.58|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.58|0.60|0.905
74065298|NCT00623623|147682850|SUPERIORITY_OR_OTHER||Relative risk|0.73||||0.12|TWO_SIDED|95.0|0.49|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.08|0.49|0.120
74065299|NCT00623623|147682851|OTHER||Relative risk|0.79||||0.17|TWO_SIDED|95.0|0.57|1.11|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.11|0.57|0.170
74065300|NCT00623623|147682852|OTHER||Relative risk|1.1||||0.758|TWO_SIDED|95.0|0.61|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.97|0.61|0.758
74065301|NCT00623623|147682853|OTHER||Relative risk|1.1||||0.663|TWO_SIDED|95.0|0.73|1.66|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.66|0.73|0.663
74065302|NCT00623623|147682854|OTHER||Relative risk|1.72||||0.148|TWO_SIDED|95.0|0.82|3.6|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||3.60|0.82|0.148
74065303|NCT00623623|147682855|OTHER||Relative risk|0.5||||0.572|TWO_SIDED|95.0|0.05|5.52|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||5.52|0.05|0.572
74065304|NCT00623623|147682856|OTHER||Relative risk|0.81||||0.207|TWO_SIDED|95.0|0.58|1.13|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.13|0.58|0.207
74065305|NCT00623623|147682857|OTHER||Relative risk|0.81||||0.1|TWO_SIDED|95.0|0.63|1.04|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.04|0.63|0.100
74065306|NCT00623623|147682858|OTHER||Relative Risk|0.91||||0.511|TWO_SIDED|95.0|0.67|1.22|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.22|0.67|0.511
73883035|NCT03988400|147299908|SUPERIORITY|||||||0.2||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.20
74065307|NCT00623623|147682859|OTHER||Relative Risk|1.75||||0.369|TWO_SIDED|95.0|0.52|5.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||5.97|0.52|0.369
73883036|NCT03988400|147299909|SUPERIORITY|||||||0.62||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.62
73883037|NCT04201431|147299915|OTHER|Comparison of pooled data from Groups 1 and 2 volunteers who completed primary CHMI with pooled data of infectivity controls undergoing primary CHMI from VAC069 study running in parallel (NCT03797989).||||||0.01||||||Two tailed p value reported for Mann-Whitney test comparing infectivity controls with vaccinees|Wilcoxon (Mann-Whitney)|||Comparison of parasite multiplication rate in vaccinated subjects compared to infectivity controls in a blood-stage controlled human malaria infection model||||0.01
73883038|NCT02913482|147299985|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
73883039|NCT02913482|147299986|SUPERIORITY|Result compared to a performance criterion of 17% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
73883040|NCT02913482|147299987|SUPERIORITY|Result compared to a performance criterion of 17% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
73883041|NCT02913482|147299993|SUPERIORITY|Result compared to a performance criterion of 12% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
74065308|NCT00623623|147682860|OTHER||Relative Risk|4.99||||0.168|TWO_SIDED|95.0|0.51|49.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||49.08|0.51|0.168
74065309|NCT00623623|147682861|OTHER||Relative Risk|8.02||||0.049|TWO_SIDED|95.0|1.0|63.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||63.97|1.00|0.049
74065310|NCT00623623|147682862|OTHER||Relative Risk|4.51||||0.054|TWO_SIDED|95.0|0.98|20.82|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||20.82|0.98|0.054
74065311|NCT00623623|147682863|OTHER||Relative Risk|2.0||||0.324|TWO_SIDED|95.0|0.5|7.99|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||7.99|0.50|0.324
74065312|NCT00623623|147682864|OTHER||Relative Risk|3.01||||0.032|TWO_SIDED|95.0|1.1|8.24|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||8.24|1.10|0.032
74065313|NCT00623623|147682865|OTHER||Relative Risk|1.36||||0.111|TWO_SIDED|95.0|0.93|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.97|0.93|0.111
74065314|NCT00623623|147682866|OTHER||Relative Risk|1.08||||0.397|TWO_SIDED|95.0|0.91|1.28|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.28|0.91|0.397
74065315|NCT00623623|147682867|OTHER||Relative Risk|1.13||||0.107|TWO_SIDED|95.0|0.97|1.31|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.31|0.97|0.107
74065316|NCT00623623|147682868|OTHER||Relative Risk|0.84||||0.471|TWO_SIDED|95.0|0.53|1.34|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.34|0.53|0.471
74065317|NCT00623623|147682869|SUPERIORITY||Relative Risk|0.35||||0.003|TWO_SIDED|95.0|0.17|0.71|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||0.71|0.17|0.003
74065318|NCT00623623|147682870|OTHER||Relative risk|1.17||||0.451|TWO_SIDED|95.0|0.78|1.73|||modified Poisson regression model|modified Poisson regression model with robust error variance||||1.73|0.78|0.451
73883042|NCT02913482|147299995|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
73883043|NCT02913482|147299996|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
73883044|NCT02913482|147299997|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.||||||1|||||||One-sided Exact Binomial Test|||||||1.0000
74065319|NCT00623623|147682871|OTHER||Relative Risk|0.87||||0.22|TWO_SIDED|95.0|0.69|1.09|||modified Poisson regression model|modified Poisson regression model with robust error variance||||1.09|0.69|0.220
74065320|NCT02186808|147682872|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73883045|NCT02913482|147299998|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.||||||1|||||||One-sided Exact Binomial Test|||||||1.0000
73883046|NCT02913482|147300002|SUPERIORITY|Result compared to a performance criterion of 42% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Z-test|||||||<0.0001
73883047|NCT02913482|147300003|SUPERIORITY|Result compared to a performance criterion of 60% derived from natural history data. Statistical analysis was only performed for Month 12 data.||||||0.0005|||||||One-sided Z-test|||||||0.0005
73883048|NCT02913482|147300004|SUPERIORITY|Result compared to a performance criterion of 89% derived from natural history data. Statistical analysis was only performed for Month 12 data.||||||0.2595|||||||One-sided Z-test|||||||0.2595
74065321|NCT01042977|147682896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.0489|<|0.0001|TWO_SIDED|95.0|-0.5|-0.3||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.30|-0.50|<0.0001
74065322|NCT01042977|147682897|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.0|||<|0.0001|TWO_SIDED|95.0|4.3|9.8||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||9.8|4.3|<0.0001
74065323|NCT01042977|147682898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.1957|<|0.0001|TWO_SIDED|95.0|-2.31|-1.54||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.54|-2.31|<0.0001
74065324|NCT01042977|147682899|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.6|STANDARD_ERROR_OF_MEAN|2.149|<|0.0001|TWO_SIDED|95.0|9.4|17.8||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline total body weight and age stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||17.8|9.4|<0.0001
74065325|NCT01042977|147682900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|0.7977||0.0007|TWO_SIDED|95.0|-4.28|-1.15||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.15|-4.28|0.0007
74065326|NCT01042977|147682901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|STANDARD_ERROR_OF_MEAN|0.7983||0.0002|TWO_SIDED|95.0|-4.59|-1.46||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.46|-4.59|0.0002
74065327|NCT01042977|147682902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.9746||0.0004|TWO_SIDED|95.0|-5.35|-1.53||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.53|-5.35|0.0004
74065328|NCT02499354|147682903|SUPERIORITY|||||||0.2742|||||||t-test, 1 sided|||||||0.2742
74065329|NCT02499354|147682904|SUPERIORITY|||||||0.55|||||||Chi-squared|||||||0.55
74065330|NCT01202994|147682942|OTHER||correlation coefficient|-0.45|||<|0.05|TWO_SIDED|||||This is a calculated p-value.|correlation|||The primary analysis is to examine the correlation between the practice effect z-score (presented in the Secondary Outcome section) and the standardized uptake value of flutemetamol (presented in the Outcome module).||||<0.05
74065331|NCT00837577|147682963|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.09|-0.75||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-0.75|-1.09|<.001
74065332|NCT00837577|147682964|SUPERIORITY_OR_OTHER||Least squares mean difference|-51.3|STANDARD_ERROR_OF_MEAN|5.6|<|0.001|TWO_SIDED|95.0|-62.3|-40.2||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-40.2|-62.3|<.001
74065333|NCT00837577|147682965|SUPERIORITY_OR_OTHER||Least squares mean difference|-22.5|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-30.0|-15.0||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-15.0|-30.0|<.001
74065334|NCT01205529|147682971|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED||||||Regression, Logistic||0 participants with rare SCN5A non-synonymous variants met the primary outcome for ST-segment elevation.||Given the very small number of outcomes (N=4) and the small number of participants with the primary determinant (N=2), a Fisher's Exact Test is the appropriate test and it yields a P-value=1.000.|||1.0
74065335|NCT01455545|147682979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.967|TWO_SIDED|95.0|0.962|1.037|||Regression, Logistic|||Ho = no differences in ASK-20 results between both groups H1= there are differences between both groups. Comparison of two means. Unilateral test. (1-alpha)=95%. Statistic power: 90%. Precision: 10. S square: 256. Sample size: 44. Sample size adjusted to losses: 46 patients.||1.037|0.962|0.967
74065336|NCT01455545|147682980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.001||||0.861|TWO_SIDED|95.0|0.985|1.018|||Regression, Logistic|||||1.018|0.985|0.861
74065337|NCT01455545|147682981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.625||||0.252|TWO_SIDED|95.0|0.706|3.739|||Chi-squared|||Ho = no differences in gender results between both groups H1= there are differences between both groups. Cross tab Chi square||3.739|0.706|0.252
74065338|NCT01455545|147682982|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Chi - square||||0.217
74065339|NCT01455545|147682983|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.643|TWO_SIDED|95.0|0.376|1.829|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi square||1.829|0.376|0.643
74065340|NCT01455545|147682984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.556||||0.155|TWO_SIDED|95.0|0.247|1.253|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||1.253|0.247|0.155
74065341|NCT01455545|147682985|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19||||0.107|TWO_SIDED|95.0|0.02|1.763|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||1.763|0.020|0.107
74065342|NCT01455545|147682986|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.849||||0.196|TWO_SIDED|95.0|1.541|2.219|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||2.219|1.541|0.196
74065343|NCT01455545|147682987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.135||||0.15|TWO_SIDED|95.0|0.618|15.91|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||15.91|0.618|0.150
74065344|NCT01455545|147682988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.096||||0.822|TWO_SIDED|95.0|0.492|2.441|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Comparison of two proportions. Unilateral test. (1-alpha)=95%. Proportion: 90%. Precision: 10%. Sample size: 35. Sample size adjusted to losses: 41 patients.||2.441|0.492|0.822
74065345|NCT01455545|147682989|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
73883049|NCT01983228|147300017|SUPERIORITY||Odds Ratio (OR)|1.61||||0.09|TWO_SIDED|95.0|0.94|2.77||Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||measured change as a responder yes/no (30% or greater improvement from baseline).||2.77|0.94|0.09
73883050|NCT01983228|147300018|SUPERIORITY||Median Difference (Final Values)|-0.2||||0.34|TWO_SIDED|95.0|-0.62|0.21||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.21|-0.62|0.34
73883051|NCT01983228|147300019|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.38|TWO_SIDED|95.0|-1.69|0.65||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.65|-1.69|0.38
74065346|NCT01455545|147682989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.038||||0.005|TWO_SIDED|95.0|1.012|1.065|||Regression, Logistic|||||1.065|1.012|0.005
73883052|NCT01983228|147300020|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.28|TWO_SIDED|95.0|-1.68|0.49||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.49|-1.68|0.28
73883053|NCT01983228|147300021|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.05|TWO_SIDED|95.0|0.0|0.77||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.77|-0.00|0.05
74065347|NCT01455545|147682990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35||||0.013|TWO_SIDED|95.0|0.153|0.799|||Regression, Logistic|||Ho = no differences between both groups H1= there are differences between both groups.||0.799|0.153|0.013
74065348|NCT00106028|147682991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.438||||0.0625|TWO_SIDED|95.0|-0.235|9.111|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||9.111|-0.235|0.0625
74065349|NCT00106028|147682992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.537||||0.6103|TWO_SIDED|95.0|-4.424|7.497|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||7.497|-4.424|0.6103
74065350|NCT00106028|147682993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.554||||0.0808||95.0|-0.193|3.301|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.301|-0.193|0.0808
74065351|NCT00106028|147682994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.498||||0.6466|TWO_SIDED|95.0|-1.648|2.644|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||2.644|-1.648|0.6466
74065352|NCT00106028|147682995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.465||||0.7391|TWO_SIDED|95.0|-3.224|2.294|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||2.294|-3.224|0.7391
74065353|NCT00106028|147682996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.333|||<|0.0001||95.0|5.258|15.408|||ANCOVA|LS Means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||15.408|5.258|<0.0001
74065354|NCT00106028|147682997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.04||||1789|TWO_SIDED|95.0|-2.807|14.887|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||14.887|-2.807|01789
74065355|NCT00106028|147682998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28||||0.9646|TWO_SIDED|95.0|-12.196|12.755|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||12.755|-12.196|0.9646
73883054|NCT01983228|147300022|SUPERIORITY|Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Mean Difference (Final Values)|193.9||||0.56|TWO_SIDED|95.0|-454.93|842.73||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||842.73|-454.93|0.56
74065356|NCT00106028|147682999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.494||||0.003||95.0|1.912|9.077|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||9.077|1.912|0.0030
74065357|NCT00106028|147683000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.473||||0.6106|TWO_SIDED|95.0|-4.245|7.192|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||7.192|-4.245|0.6106
74065358|NCT00106028|147683001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.315||||0.9372|TWO_SIDED|95.0|-7.598|8.229|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||8.229|-7.598|0.9372
74065359|NCT00106028|147683002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.675|||<|0.0001||95.0|21.051|42.3|||ANCOVA|LS means and p-value are from ANCOVA model adjusted for baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||42.300|21.051|<0.0001
74065360|NCT00106028|147683003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.029||||0.0793|TWO_SIDED|95.0|-1.667|29.726|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||29.726|-1.667|0.0793
74065361|NCT00106028|147683004|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.567|||<|0.0001||95.0|5.59|11.545|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||11.545|5.590|<0.0001
74065362|NCT00106028|147683005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.315||||0.4575|TWO_SIDED|95.0|-10.477|23.107|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||23.107|-10.477|0.4575
74065363|NCT00106028|147683006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.594||||0.0172||95.0|6.801|68.386|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||68.386|6.801|0.0172
74065364|NCT00106028|147683007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.492||||0.9786|TWO_SIDED|95.0|-36.807|35.824|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||35.824|-36.807|0.9786
74065365|NCT00106028|147683008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.64||||0.5971|TWO_SIDED|95.0|-40.952|23.672|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||23.672|-40.952|0.5971
73883055|NCT01983228|147300023|SUPERIORITY||Odds Ratio (OR)|1.49||||0.16|TWO_SIDED|95.0|0.85|2.62||Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||measured change as a responder yes/no (30% or greater improvement from baseline).||2.62|0.85|0.16
73883056|NCT01983228|147300024|SUPERIORITY||Mean Difference (Final Values)|-0.61||||0.002|TWO_SIDED|95.0|-0.99|-0.23||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||-0.23|-0.99|0.002
73883057|NCT01983228|147300025|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.54|TWO_SIDED|95.0|-0.79|1.51||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.51|-0.79|0.54
74065366|NCT00106028|147683009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.014||||0.4154||95.0|-1.442|3.47|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.470|-1.442|0.4154
73883058|NCT01983228|147300026|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.41|TWO_SIDED|95.0|-0.66|1.62||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.62|-0.66|0.41
73883059|NCT01983228|147300027|SUPERIORITY||Mean Difference (Final Values)|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.38||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||-0.38|-1.07|<0.0001
74065367|NCT00106028|147683010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.884||||0.6404|TWO_SIDED|95.0|-2.855|4.623|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||4.623|-2.855|0.6404
73883060|NCT01983228|147300028|SUPERIORITY||Mean Difference (Final Values)|540.78||||0.06|TWO_SIDED|95.0|-28.77|1110.33||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1110.33|-28.77|0.06
73883061|NCT01983228|147300029|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.05|TWO_SIDED|95.0|-0.01|5.86||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||5.86|-0.01|0.05
74065368|NCT00106028|147683011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.66||||0.4978|TWO_SIDED|95.0|-6.499|3.179|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.179|-6.499|0.4978
74065369|NCT00106028|147683012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.534||||0.027||95.0|0.41|6.658|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.658|0.410|0.0270
74065370|NCT00106028|147683013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.065||||0.5925|TWO_SIDED|95.0|-2.868|4.998|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||4.998|-2.868|0.5925
74065371|NCT00106028|147683014|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.193||||0.684|TWO_SIDED|95.0|-4.604|6.991|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.991|-4.604|0.6840
74065372|NCT00106028|147683015|SUPERIORITY_OR_OTHER|||||||0.068||95.0|||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.0680
73883062|NCT01983228|147300030|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.01|TWO_SIDED|95.0|0.15|1.36||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.36|0.15|0.01
74065373|NCT00106028|147683016|SUPERIORITY_OR_OTHER|||||||0.4121||95.0|||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.4121
73883063|NCT01983228|147300031|SUPERIORITY||Mean Difference (Final Values)|-1.07||||0.15|TWO_SIDED|95.0|-2.53|0.39||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.39|-2.53|0.15
74065374|NCT00106028|147683017|SUPERIORITY_OR_OTHER|||||||0.3658||95.0|||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.3658
74065375|NCT00106028|147683018|SUPERIORITY_OR_OTHER|||||||0.3408||95.0|||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.3408
74065376|NCT00106028|147683021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.534||||0.0253||95.0|0.31|0.922||All Fractures|Cox proportional hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.922|0.310|0.0253
74065377|NCT00106028|147683021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.534||||0.0253|TWO_SIDED|95.0|0.31|0.922||All Non-Vertebral Fractures|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.922|0.310|0.0253
73883064|NCT01983228|147300032|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.56|TWO_SIDED|95.0|-0.8|1.47||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.47|-0.80|0.56
74065378|NCT00106028|147683021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.487||||0.0501|TWO_SIDED|95.0|0.25|0.95||Long Bone Non-Vertebral Fracture|Cox Proportional Hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.950|0.250|0.0501
73883065|NCT01983228|147300033|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.38|TWO_SIDED|95.0|-0.17|0.46||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.46|-0.17|0.38
73883066|NCT01983228|147300034|SUPERIORITY||Odds Ratio (OR)|1.2||||0.56|TWO_SIDED|95.0|0.66|2.19||Logistic regression modeling the odds of yes to using opioids for pain treatment adjusting for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||||2.19|0.66|0.56
73883067|NCT01983228|147300035|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.21|TWO_SIDED|95.0|-0.18|0.84||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.84|-0.18|0.21
73883068|NCT00771914|147300045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from baseline compared to four hours after placebo.||||0.00
73883069|NCT00771914|147300045|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12.0||||0.31|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Aspirin compared to Placebo.||||0.31
73883070|NCT00771914|147300045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0||||0.49|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Lovaza compared to Placebo.||||0.49
73883071|NCT00771914|147300045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0||||0.03|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from both Aspirin and Lovaza compared to Placebo.||||0.03
73883072|NCT03111875|147300063|SUPERIORITY|common effect|Risk Ratio (RR)|1.04||||0.69|TWO_SIDED|95.6|0.87|1.24|||Mixed Models Analysis|||||1.24|0.87|0.69
74065379|NCT00106028|147683021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.608||||0.2141|TWO_SIDED|95.0|0.262|1.41||Other Non-Vertebral Fracture|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.410|0.262|0.2141
74065380|NCT00106028|147683022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.584||||0.0416||95.0|0.348|0.98||All Fractures|Wald test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.980|0.348|0.0416
74065381|NCT00106028|147683022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.584||||0.0416|TWO_SIDED|95.0|0.348|0.98||Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.980|0.348|0.0416
74065382|NCT00106028|147683022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.543||||0.0799|TWO_SIDED|95.0|0.274|1.076||Long Bone Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.076|0.274|0.0799
74065383|NCT00106028|147683022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.682|TWO_SIDED|95.0|0.304|1.532||Other Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.532|0.304|0.682
74065384|NCT00106028|147683023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.678||||0.0318||95.0|-22.325|-1.031|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||-1.031|-22.325|0.0318
73883073|NCT03111875|147300063|SUPERIORITY|average relative effect|Risk Ratio (RR)|0.68||||0.1|TWO_SIDED|95.6|0.43|1.08|||Mixed Models Analysis|||||1.08|0.43|0.10
73883074|NCT03111875|147300064|SUPERIORITY||Risk Ratio (RR)|1.13||||0.25|TWO_SIDED|98.75|0.87|1.47|||log-binomial models|The relative risk was estimated using a GEE model to adjust for within-patient correlation across components and log link (to estimate relative risk).||||1.47|0.87|0.25
74065385|NCT00106028|147683024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.9907|TWO_SIDED|95.0|-11.401|11.536|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||11.536|-11.401|0.9907
73883075|NCT03111875|147300065|SUPERIORITY||Risk Ratio (RR)|1.07||||0.41|TWO_SIDED|98.75|0.87|1.33|||log-binomial models|The relative risk was estimated using a GEE model to adjust for within-patient correlation across components and log link (to estimate relative risk)||||1.33|0.87|0.41
74065386|NCT00106028|147683025|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.686||||0.3826|TWO_SIDED|95.0|-15.276|5.903|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||5.903|-15.276|0.3826
74065387|NCT00106028|147683026|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.629|||<|0.0001||95.0|-38.089|-15.169|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||-15.169|-38.089|<0.0001
74065388|NCT00106028|147683027|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.04||||0.3075|TWO_SIDED|95.0|-8.433|26.512|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||26.512|-8.433|0.3075
74065389|NCT00106028|147683028|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.039||||0.3998|TWO_SIDED|95.0|-16.849|6.772|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.772|-16.849|0.3998
74065390|NCT00106028|147683029|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.352||||0.1592||95.0|-0.845|0.14|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.140|-0.845|0.1592
74065391|NCT00106028|147683030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127||||0.2917||95.0|-0.111|0.365|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.365|-0.111|0.2917
74065392|NCT00106028|147683031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007||||0.9622||95.0|-0.304|0.319|||ANOVA|LS mean and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.319|-0.304|0.9622
73883076|NCT01323582|147300086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6|STANDARD_ERROR_OF_MEAN|11.7||0.76|TWO_SIDED|95.0|-21.5|28.6|||t-test, 2 sided|Satterthwaite corrected t-test was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.||28.6|-21.5|0.76
73883077|NCT01323582|147300087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.8||0.65||95.0|-4.8|7.5|||t-test, 2 sided|Satterthwaite Correction used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.||7.5|-4.8|0.65
74065393|NCT00106028|147683032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.009||||0.9596|TWO_SIDED|95.0|-0.336|0.354|||ANOVA|LS means and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.354|-0.336|0.9596
74065394|NCT00106028|147683033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.107||||0.34||95.0|-0.114|0.328|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.328|-0.114|0.3400
74065395|NCT00106028|147683034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.029||||0.6218|TWO_SIDED|95.0|-0.084|0.142|||ANOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.142|-0.084|0.6218
73888291|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|39.4||||0.1078|TWO_SIDED|95.0|-8.7|87.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||87.4|-8.7|0.1078
74065396|NCT03276962|147683058|SUPERIORITY||Incremental vaccine efficacy|-21.0||||0.154|TWO_SIDED|95.0|-57.0|7.0|||Regression, Cox|The 95% Confidence Interval of the incremental vaccine efficacy estimates was calculated from Cox regression model.||To demonstrate the superiority of a 3-dose schedule of GSK Biologicals' malaria vaccine RTS,S/AS01E with a fractional third dose at Month 2 (Fx012-14-mFxD Group) compared to a standard schedule of RTS,S/AS01E with 3 full doses (R012-20 + R012-14 Group) in terms of vaccine efficacy against clinical malaria (primary case definition) over 12 months post-Dose 3.||7|-57|0.154
74065397|NCT03550794|147683106|OTHER||Mean Difference (Final Values)|-0.57||||0.07|TWO_SIDED|95.0|-1.18|0.04||"Mixed model controlling for repeated measures within patients used to get a mean difference in creatinine between the thiamine and placebo groups at 72 hours.~Missing creatinine imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||0.04|-1.18|0.07
74065398|NCT03550794|147683107|OTHER||Odds Ratio (OR)|0.58||||0.34|TWO_SIDED|95.0|0.18|1.74||P-value from odds ratio from logistic regression model controlling for site, with outcome of receiving renal replacement therapy.|Regression, Logistic|||||1.74|0.18|0.34
74065399|NCT03550794|147683108|OTHER||Median Difference (Final Values)|22.0||||0.002|TWO_SIDED|95.0|7.4|36.6||P-value from quantile regression model controlling for site.|Quantile regression|||||36.6|7.4|0.002
74065400|NCT03550794|147683109|OTHER||Hazard Ratio (HR)|0.62||||0.14|TWO_SIDED|95.0|0.32|1.18||P-value from Cox proportional hazards model adjusting for site.|Regression, Cox|||||1.18|0.32|0.14
74065401|NCT03550794|147683110|OTHER||Odds Ratio (OR)|0.43||||0.07|TWO_SIDED|95.0|0.17|1.06||P-value from logistic regression model controlling for site|Regression, Logistic|||||1.06|0.17|0.07
74065402|NCT03550794|147683111|OTHER||Mean Difference (Final Values)|0.96||||0.79|TWO_SIDED|95.0|0.71|1.3||"Mixed model controlling for repeated measures within patients used to get a mean difference in lactate between the thiamine and placebo groups at 72 hours.~Missing lactate imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||1.30|0.71|0.79
74065403|NCT03550794|147683113|OTHER||Mean Difference (Final Values)|-1.53||||0.16|TWO_SIDED|95.0|-3.63|0.58||"Mixed model controlling for repeated measures within patients used to get a mean difference in SOFA scores between the thiamine and placebo groups at 72 hours.~Missing SOFA imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||0.58|-3.63|0.16
74065404|NCT02278952|147683130|OTHER|Generalized estimating equation-adjusted linear models||||||0.33|||||||GEE-adjusted models|||||||0.33
74065405|NCT02278952|147683131|OTHER|Generalized estimating equation-adjusted linear model|||||<|0.0001|||||||GEE-adjusted linear model|||||||< 0.0001
74065406|NCT02278952|147683132|OTHER|Generalized estimating equation-adjusted linear models||||||0.049|||||||GEE-adjusted linear models|||||||0.049
74065407|NCT02278952|147683133|OTHER|Generalized estimating equation-adjusted linear models||||||0.114|||||||GEE-adjusted linear models|||||||0.114
74065408|NCT02278952|147683134|OTHER|Generalized estimating equation-adjusted linear models||||||0.47|||||||GEE-adjusted linear models|||P-value of tacrolimus dose||||0.470
74065409|NCT02278952|147683134|OTHER|Generalized estimating equation-adjusted linear models||||||0.037|||||||GEE-adjusted linear models|||P-value of Prednisone dose||||0.037
74065410|NCT02278952|147683134|OTHER|Generalized-estimating equation-adjusted linear models||||||0.456|||||||GEE-adjusted linear models|||P-value of mycophenolate mofetil dose||||0.456
74065411|NCT01989195|147683148|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74065412|NCT01963676|147683177|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from Day 5 to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups:~H0: μ1 = μ2 μ1: mean(difference 5 days-baseline) for tDCS group (n=13) μ2: mean(difference 5 days-baseline) for sham group (n=13)"||||0.48
74065413|NCT01963676|147683178|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED|||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from 1 Month to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the AHRS score changes from baseline to 1month between the groups:~H0: μ1 = μ2 μ1: mean(difference 1 month-baseline) for tDCS group (n=13) μ2: mean(difference 1 month-baseline) for sham group (n=13)"||||0.86
74065414|NCT01246973|147683179|SUPERIORITY_OR_OTHER|||||||0.6555|TWO_SIDED||||||F-test|||||||0.6555
74065415|NCT01246973|147683180|SUPERIORITY_OR_OTHER|||||||0.3504|TWO_SIDED||||||Chi-squared|||||||0.3504
74065416|NCT00766506|147683181|SUPERIORITY_OR_OTHER||Least square mean difference|-2.23|||<|0.001|TWO_SIDED|95.0|-2.55|-1.91|||ANCOVA|P-value was calculated from analysis of covariance (ANCOVA), with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group|||-1.91|-2.55|<0.001
74065417|NCT00766506|147683182|SUPERIORITY_OR_OTHER|||||||0.219|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 24||||0.219
74065418|NCT00766506|147683182|SUPERIORITY_OR_OTHER|||||||0.299|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 48||||0.299
74065419|NCT00766506|147683182|SUPERIORITY_OR_OTHER|||||||0.136|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At study discontinuation or withdrawal||||0.136
74065420|NCT00766506|147683183|SUPERIORITY_OR_OTHER||Least square mean difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group|||-0.30|-0.74|<0.001
74065421|NCT00766506|147683184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.131|TWO_SIDED|95.0|0.84|3.92|||Mantel Haenszel|P-value was calculated from a Mantel-Haenszel Chi-Squared test.||||3.92|0.84|0.131
74065422|NCT00766506|147683185|SUPERIORITY_OR_OTHER|||||||0.342|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.||||||0.342
74065423|NCT00766506|147683186|SUPERIORITY_OR_OTHER|||||||0.836|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.||||||0.836
74065424|NCT00766506|147683187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.029|TWO_SIDED|95.0|1.04|24.03|||Chi-squared|||||24.03|1.04|0.029
74065425|NCT00766506|147683189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.23|TWO_SIDED|95.0|0.74|3.53|||Chi-squared|||Paracetamol: P-value was calculated using Chi-squared test.||3.53|0.74|0.230
74065426|NCT00766506|147683189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.163|TWO_SIDED|95.0|0.8|3.7|||Chi-squared|||NSAID's: P-value was calculated using Chi-squared test.||3.70|0.80|0.163
74065427|NCT02496221|147683191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0021||||0.1229|TWO_SIDED|95.0|-20.5781|2.5739|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||2.5739|-20.5781|0.1229
74065428|NCT02496221|147683192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-545.9585||||0.1291|TWO_SIDED|95.0|-1260.0|168.0858|||Mixed Models Analysis|||||168.0858|-1260.00|0.1291
74065429|NCT02496221|147683194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2992||||0.0317|TWO_SIDED|95.0|-31.0762|-1.5223|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||-1.5223|-31.0762|0.0317
74065430|NCT02496221|147683195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|252.6099||||0.0291|TWO_SIDED|95.0|29.5081|475.7117|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||475.7117|29.5081|0.0291
74065431|NCT02496221|147683196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3748||||0.7961|TWO_SIDED|95.0|-3.4109|2.6614|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||2.6614|-3.4109|0.7961
74065432|NCT02496221|147683198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001526||||0.9424|TWO_SIDED|95.0|-0.045665|0.048717|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||0.048717|-0.045665|0.9424
74065433|NCT02496221|147683199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01456||||0.0733|TWO_SIDED|95.0|-0.030666|0.001554|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||0.001554|-0.030666|0.0733
74065434|NCT01893983|147683210|EQUIVALENCE|Compare whether 2 groups had any difference in risk/hazard of mental health engagement at any time during follow-up.|Cox Proportional Hazard|1.13||||0.66|TWO_SIDED|95.0|0.81|1.58||P value 0.05 is the threshold for statistical significance|Regression, Cox|Adjusted for site, mental health treatment history and mental health symptom severity at baseline, baseline amphetamine and opioid scores.|The referral alone arm is the reference group (denominator), and the motivational coaching arm is the numerator.|Compare 2 groups in regard to time to first mental health treatment using Cox proportional hazards regression.||1.58|0.81|0.660
74065435|NCT01120600|147683214|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.59|||<|0.001|TWO_SIDED|95.0|4.48|6.7|||cLDA|||A constrained full likelihood longitudinal data analysis (cLDA) method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||6.7|4.48|< 0.001
74065436|NCT01120600|147683215|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.02|||<|0.001|TWO_SIDED|95.0|1.27|2.77|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||2.77|1.27|< 0.001
74065437|NCT01120600|147683216|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.69|||=|0.008|TWO_SIDED|95.0|0.45|2.93|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||2.93|0.45|= 0.008
74065438|NCT01120600|147683217|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.12|||<|0.001|TWO_SIDED|95.0|0.93|3.3|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||3.3|0.93|< 0.001
74065439|NCT01120600|147683218|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-76.58|||<|0.001|TWO_SIDED|95.0|-92.56|-60.61|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-60.61|-92.56|< 0.001
74065440|NCT01120600|147683219|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-68.08|||<|0.001|TWO_SIDED|95.0|-78.1|-58.06|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-58.06|-78.1|< 0.001
74065441|NCT01120600|147683220|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.94|||=|0.019|TWO_SIDED|95.0|-14.58|-1.31|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-1.31|-14.58|= 0.019
74065442|NCT01120600|147683221|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.0|||=|0.001|TWO_SIDED|95.0|-25.74|-6.27|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-6.27|-25.74|= 0.001
74065443|NCT00361257|147683251|SUPERIORITY_OR_OTHER||Slope|0.064|STANDARD_ERROR_OF_MEAN|0.164||0.651|TWO_SIDED|95.0|-0.258|0.386||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline NPZ-8 score.|The total number used for the statistical analysis was 107 (52 in the minocycline arm and 55 in the placebo arm).|The null hypothesis was that the 24-week change of NPZ-8 in the minocycline group was the same as the one in the placebo group.||0.386|-0.258|0.651
73883078|NCT01323582|147300088|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|2.3||0.88|TWO_SIDED|95.0|-4.58|5.19|||t-test, 2 sided|Satterthwaite correction for unequal standard deviations was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Half of the period 2 minus period 1 differences were used, since the difference between these two derived means is an unbiased estimate of the effect size.||5.19|-4.58|0.88
73883079|NCT01323582|147300089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.49|STANDARD_ERROR_OF_MEAN|5.7||0.8|TWO_SIDED|95.0|-13.9|10.9|||t-test, 2 sided|Satterthwaite Corrected t-test|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|||10.9|-13.9|0.80
74065444|NCT00361257|147683252|SUPERIORITY_OR_OTHER||Slope|0.091|STANDARD_ERROR_OF_MEAN|0.116||0.434|TWO_SIDED|95.0|-0.14|0.323||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline GDS score.||The null hypothesis was that the 24-week changes in Global Deficit Score (GDS) between the minocycline and placebo groups are the same.||0.323|-0.140|0.434
74065445|NCT00361257|147683253|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.569|STANDARD_DEVIATION|0.469||0.337|TWO_SIDED|95.0|0.625|3.936||The p-value was not adjusted for multiple comparisons.|Regression, Cumulative Logistic|The model was adjusted for the stratification variables and the CNS penetration score.||The null hypothesis is that the 24 week changes of participants' clinical status in the minocycline group were the same as the ones in the placebo group based on ICGIS.||3.936|0.625|0.337
73883080|NCT01323582|147300090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.8|STANDARD_ERROR_OF_MEAN|9.1||0.21|TWO_SIDED|95.0|-30.9|7.3|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.|||7.3|-30.9|0.21
74065446|NCT00361257|147683254|SUPERIORITY_OR_OTHER||Slope|0.502|STANDARD_ERROR_OF_MEAN|0.428||0.243|TWO_SIDED|95.0|-0.349|1.354||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline cognitive gross motor function domain score.||The null hypothesis is that the 24 week change in the cognitive gross motor function domain score in the minocycline group is the same as the one in the placebo group.||1.354|-0.349|0.243
73883081|NCT01323582|147300091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|STANDARD_ERROR_OF_MEAN|6.61||0.034|TWO_SIDED|95.0|-28.7|-1.26|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.|||-1.26|-28.7|0.034
73883082|NCT01323582|147300092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.32|STANDARD_ERROR_OF_MEAN|1.98||0.015|TWO_SIDED|95.0|-9.48|-1.16|||t-test, 2 sided||Lower scores are favorable.|||-1.16|-9.48|0.015
73883083|NCT01323582|147300093|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.4|STANDARD_ERROR_OF_MEAN|2.2||0.0083|TWO_SIDED|95.0|-10.97|-1.83|||t-test, 2 sided||Lower scores are favorable.|||-1.83|-10.97|0.0083
73883084|NCT00960375|147300100|SUPERIORITY_OR_OTHER|||||||0.489|TWO_SIDED||||||ANOVA|||Smoking reduction outcomes were examined in the randomized sample using data from baseline and post-treatment assessments. The variable examined was self-reported number of cigarettes smoked per day during the last 7 days. This variable was skewed so a natural log transformation was applied before linear mixed model analysis.||||0.489
74065447|NCT00361257|147683255|SUPERIORITY_OR_OTHER||Slope|0.293|STANDARD_ERROR_OF_MEAN|0.153||0.059|TWO_SIDED|95.0|-0.011|0.596||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor function domain score.||The null hypothesis was that the 24 week change in fine motor function domain score in the minocycline group was the same as the one in the placebo group.||0.596|-0.011|0.059
74065448|NCT00361257|147683256|SUPERIORITY_OR_OTHER||Slope|-0.083|STANDARD_ERROR_OF_MEAN|0.147||0.572|TWO_SIDED|95.0|-0.375|0.209||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratified variables, the baseline CNS penetration score, and the baseline psychomotor function domain score.||The null hypothesis was that the 24 change of psychomotor function domain score in the minocycline group is the same as in the placebo group.||0.209|-0.375|0.572
74065449|NCT00361257|147683257|SUPERIORITY_OR_OTHER||Slope|-0.086|STANDARD_ERROR_OF_MEAN|0.182||0.637|TWO_SIDED|95.0|-0.449|0.276||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor/nonverbal function domain score.||The null hypothesis was that the 24 week change of fine motor/nonverbal function domain score in the minocycline group was the same as in the placebo group.||0.276|-0.449|0.637
74065450|NCT00361257|147683258|SUPERIORITY_OR_OTHER||Slope|-0.074|STANDARD_ERROR_OF_MEAN|0.236||0.754|TWO_SIDED|95.0|-0.544|0.396||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline information processing function domain score.||The null hypothesis was that the 24 week change of information processing function domain score in the minocycline group was the same as the one in the placebo group.||0.396|-0.544|0.754
74065451|NCT00361257|147683259|SUPERIORITY_OR_OTHER||Slope|0.145|STANDARD_ERROR_OF_MEAN|0.207||0.484|TWO_SIDED|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline verbal memory domain score.||The null hypothesis was that the 24 week change of verbal memory domain score in the minocycline group was the same as the one in the placebo group.||0.558|-0.266|0.484
74065452|NCT00361257|147683260|SUPERIORITY_OR_OTHER||Slope|-0.126|STANDARD_ERROR_OF_MEAN|0.172||0.467|TWO_SIDED|95.0|-0.467|0.216||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline frontal systems function domain score.||The null hypothesis was that the 24 week change of frontal systems function domain score in the minocycline group was the same as the one in the placebo group.||0.216|-0.467|0.467
74065453|NCT00361257|147683261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.476|STANDARD_DEVIATION|1.048||0.234|TWO_SIDED|95.0|0.575|10.668||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the CNS penetration score. The stratification variables could not be included in the model since the model fit was poor.||"The null hypothesis was that the proportion of being better at 24 weeks in minocycline group was the same as in the placebo group."||10.668|0.575|0.234
73883085|NCT00960375|147300101|SUPERIORITY_OR_OTHER|||||||0.685|TWO_SIDED||||||ANOVA|||This outcome was examined in the randomized sample. Abstinence was defined as self-reported no smoking in the last 7 days + expired CO ≤ 10 PPM. To assess difference in change between conditions, we tested the significance of the condition-by-time interaction using repeated measured mixed models with a random participant effect. Time was binary: post-treatment versus baseline. We used a logistic model for binary outcomes.||||0.685
73883086|NCT03409796|147300127|OTHER|||||||0.385|||||||t-test, 1 sided|||Gluten 3 gram: Baseline versus Day 15. Change in Vh:Cd follows a normal distribution. A 1-sided paired t-test was used to compare Baseline and follow-up Vh:Cd measures. The normality assumption was checked using the Shapiro-Wilk test. If the data was not normal at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare Vh:CdBaseline (B) and Vh:Cd15.||||0.385
73883087|NCT03409796|147300127|OTHER|||||||0.003|||||||t-test, 1 sided|||Gluten 10 gram: Baseline versus Day 15. Change in Vh:Cd follows a normal distribution. A 1-sided paired t-test was used to compare Baseline and follow-up Vh:Cd measures. The normality assumption was checked using the Shapiro-Wilk test. If the data was not normal at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare Vh:CdB and Vh:Cd15.||||0.003
73888292|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|196.0|||<|0.0001|TWO_SIDED|95.0|116.9|275.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||275.1|116.9|<0.0001
74065454|NCT00361257|147683262|SUPERIORITY_OR_OTHER||Slope|19.09|STANDARD_ERROR_OF_MEAN|33.75||0.574|TWO_SIDED|95.0|-48.26|86.44||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the baseline CNS score, and the baseline CD4 cell count.||The null hypothesis was that the 24 week change in CD4 cell counts in the minocycline group was the same as the one in the placebo group.||86.44|-48.26|0.574
74065455|NCT00361257|147683263|SUPERIORITY_OR_OTHER||Slope|40.43|STANDARD_ERROR_OF_MEAN|59.91||0.502|TWO_SIDED|95.0|-79.12|159.97||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline CD8 cell counts.||The null hypothesis was that the 24 week change in CD8 cell count in the minocycline group was the same as the one in the placebo group.||159.97|-79.12|0.502
74065456|NCT00361257|147683264|SUPERIORITY_OR_OTHER|||||||0.967||95.0|||||Log Rank|||The null hypothesis was that the time to Grade 2 or higher toxicity and/or signs and symptoms in the minocycline group was the same as the one in the placebo group.||||0.967
74065457|NCT00361257|147683266|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.071|STANDARD_ERROR_OF_MEAN|0.497||0.89|TWO_SIDED|95.0|0.405|2.837||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|The model was adjusted for the stratification variables and the baseline CNS penetration score.||The null hypothesis was that the proportion of participants who got better at week 24 compared to baseline in the minocycline group was the same as the one in the placebo group.||2.837|0.405|0.890
74065458|NCT00361257|147683267|SUPERIORITY_OR_OTHER||Slope|-0.405|STANDARD_ERROR_OF_MEAN|0.391||0.304|TWO_SIDED|95.0|-1.182|0.373||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline medication management score.||The null hypothesis was that the 24 change of medication management test score in the minocycline group was the same as the one in the placebo group.||0.373|-1.182|0.304
74065459|NCT00361257|147683272|SUPERIORITY_OR_OTHER||Slope|-0.097|STANDARD_ERROR_OF_MEAN|0.146||0.506|TWO_SIDED|95.0|-0.388|0.193||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline alternate psychomotor function score.||The null hypothesis was that the 24 week change in alternate psychomotor function score in the minocycline group was the same as the one in the placebo group.||0.193|-0.388|0.506
73888293|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.9726|TWO_SIDED|95.0|-77.7|80.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.5|-77.7|0.9726
74065460|NCT00361257|147683273|SUPERIORITY_OR_OTHER||Slope|0.146|STANDARD_ERROR_OF_MEAN|0.207||0.484|TWO_SIDED|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate verbal memory score.||The null hypothesis was that the 24 week change in the alternate verbal memory score in the minocycline group was the same as the one in the placebo group.||0.558|-0.266|0.484
73883088|NCT03409796|147300128|OTHER|||||||0.01|||||||Poisson distribution|||Gluten 3 gram: Baseline versus Day 15. The Poisson distribution assumption was checked using Kolmogorov-Smirnov test. Poisson generalized linear mixed models (GLMM) was fitted to data, where IEL measurements were grouped by participant (the random effect) and the change in IEL counts was the fixed effect. If the data was found to not be Poisson at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare IELB and IEL15.||||0.010
74065461|NCT00361257|147683274|SUPERIORITY_OR_OTHER||Slope|0.055|STANDARD_ERROR_OF_MEAN|0.137||0.69|TWO_SIDED|95.0|-0.217|0.327||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate frontal systems score.||The null hypothesis was the 24 week change of alternate frontal systems score in the minocycline group was the same as the one in the placebo group.||0.327|-0.217|0.690
74065462|NCT00660790|147683277|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||The paired student's t-test or the Wilcoxon signed-rank test was used to compare the measurements before and after multifactorial treatment, as appropriate, depending on the distribution of the data.||||0.021
74065463|NCT03840811|147683278|OTHER|||||||0.23|||||||Sign test|||To assess whether the fitness of a given mutant is different than that of wild-type, the ratio of colony-forming units of the mutant strain was compared to those of the WT strain at the time of treatment and in the inoculum using a Wilcoxon Signed-Rank Test with a significance level of 0.025. CIs of participants in Mixed FA1090 + FA7537 group were compared to mean = 1.||||0.230
74065464|NCT03840811|147683279|OTHER||Risk Difference (RD)|-0.14||||0.54|TWO_SIDED|95.0|-0.58|0.34||One-sided Fisher's Exact Test with alpha=0.025|Fisher Exact|||||0.34|-0.58|0.54
74065465|NCT01625845|147683285|SUPERIORITY_OR_OTHER|||||||0.474|TWO_SIDED|95.0|||||ANCOVA|||||||.474
74065466|NCT01625845|147683286|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0|||||ANCOVA|||||||.068
74065467|NCT01625845|147683287|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED|95.0|||||ANCOVA|||||||.296
74065468|NCT01625845|147683288|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED|95.0|||||ANCOVA|||||||.203
74065469|NCT01625845|147683289|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||ANCOVA|||||||.906
74065470|NCT01625845|147683290|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED|95.0|||||ANCOVA|||||||.869
74065471|NCT01625845|147683291|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0|||||ANCOVA|||||||.026
74065472|NCT01078623|147683292|SUPERIORITY_OR_OTHER||Least squares mean difference|0.221|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.174|0.268|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate||||0.268|0.174|<0.0001
74065473|NCT01078623|147683292|SUPERIORITY_OR_OTHER||Least squares mean difference|0.234|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.186|0.281|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate||||0.281|0.186|<0.0001
74065474|NCT04356573|147683296|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
74065475|NCT01577537|147683302|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74065476|NCT00950833|147683309|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 1.|GMC ratio for anti-1|6.17|||||TWO_SIDED|95.0|5.03|7.58|||ANOVA|||To demonstrate the immunological memory induced for anti-pneumococcal serotype 1 following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||7.58|5.03|
74065477|NCT00950833|147683309|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled SynflorixI+II Group over Synflorix Group) was higher than 1 for pneumococcal serotype 4.|GMC ratio for anti-4|2.86|||||TWO_SIDED|95.0|2.38|3.45|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 4 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||3.45|2.38|
74065478|NCT00950833|147683309|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 5.|GMC ratio for anti-5|13.47|||||TWO_SIDED|95.0|10.96|16.55|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 5 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||16.55|10.96|
74065479|NCT00950833|147683309|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 6B.|GMC ratio for anti-6B|28.81|||||TWO_SIDED|95.0|22.54|36.81|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 6B induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||36.81|22.54|
74065480|NCT00950833|147683309|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 7F.|GMC ratio for anti-7F|4.75|||||TWO_SIDED|95.0|3.9|5.78|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 7F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||5.78|3.9|
74065481|NCT00950833|147683309|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 9V.|GMC ratio for anti-9V|14.1|||||TWO_SIDED|95.0|11.21|17.75|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 9V induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||17.75|11.21|
74065482|NCT00950833|147683309|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 14.|GMC ratio for anti-14|22.92|||||TWO_SIDED|95.0|17.51|30.0|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 14 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||30|17.51|
74065483|NCT00950833|147683309|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 18C.|GMC ratio for anti-18C|10.01|||||TWO_SIDED|95.0|7.95|12.61|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 18C induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||12.61|7.95|
73883089|NCT03409796|147300128|OTHER|||||||0.006|||||||Poisson distribution|||Gluten 10 gram: Baseline versus Day 15. The Poisson distribution assumption was checked using Kolmogorov-Smirnov test. Poisson GLMM was fitted to data, where IEL measurements were grouped by participant (the random effect) and the change in IEL counts was the fixed effect. If the data was found to not be Poisson at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare IELB and IEL15.||||0.006
73883090|NCT01602224|147300144|SUPERIORITY||Odds Ratio (OR)|1.98||||0.401|TWO_SIDED||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.||||0.401
74065484|NCT00950833|147683309|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 19F.|GMC ratio for anti-19F|9.25|||||TWO_SIDED|95.0|7.29|11.74|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 19F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||11.74|7.29|
74065485|NCT00950833|147683309|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 23F.|GMC ratio for anti-23F|36.52|||||TWO_SIDED|95.0|27.59|48.34|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 23F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||48.34|27.59|
74065486|NCT04132232|147683336|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
74065487|NCT00368537|147683339|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|0.0||||||95.0|-8.7|8.6|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|||8.6|-8.7|
74065488|NCT00368537|147683340|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.2||||||95.0|-9.6|14.0|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|||14.0|-9.6|
74065489|NCT00368537|147683341|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.4||||||95.0|-9.6|14.4|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|Group comparison of eradication + presumed eradication||14.4|-9.6|
74065490|NCT00368537|147683343|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.2||||0.444||95.0|-4.4|2.0|||Fisher Exact|2-sided||Intensive care unit||2.0|-4.4|0.444
74065491|NCT01368276|147683356|SUPERIORITY_OR_OTHER||Treatment Difference|-42.9||||0.2645|TWO_SIDED|||||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF|||||0.2645
74065492|NCT01368276|147683357|SUPERIORITY_OR_OTHER||Treatment Difference|-1.2||||1|TWO_SIDED|95.0|-57.3|54.9||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF|||54.9|-57.3|1.0000
74065493|NCT00528879|147683383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1014||0.0002||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0002
74065494|NCT00528879|147683383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1016|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
74065495|NCT00528879|147683383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1021|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
73883091|NCT01602224|147300144|SUPERIORITY||Odds Ratio (OR)|1.84||||0.455|TWO_SIDED||||||Regression, Logistic|||300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.||||0.455
74065496|NCT00528879|147683384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|STANDARD_ERROR_OF_MEAN|3.774|<|0.0019||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0019
74065497|NCT00528879|147683384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|STANDARD_ERROR_OF_MEAN|3.781|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
74065498|NCT00528879|147683384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|STANDARD_ERROR_OF_MEAN|3.819|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
74065499|NCT00528879|147683385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
74065500|NCT00528879|147683385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
74065501|NCT00528879|147683385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.3365|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
74065502|NCT00528879|147683386|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.1||||0.1775||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.1775
74065503|NCT00528879|147683386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7||||0.0275||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0275
73883092|NCT01602224|147300144|SUPERIORITY||Odds Ratio (OR)|1.9||||0.419|TWO_SIDED||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib and 300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only compared to placebo.||||0.419
73883093|NCT01352117|147300146|SUPERIORITY|||||||0.911||||||The critical value for the final analysis was adjusted for the three interim analyses conducted for the Data and Safety Monitoring Board (DSMB) review using the Haybittle-Peto guidelines, at the p-value cutoff of 0.0487.|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon-Mann-Whitney test (asymptotic method) known as van Elteren test, stratification by screening CD4 (\<200 vs. \>=200 cells/mm\^3).||||||0.911
73883094|NCT00770653|147300185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267||||0.0018|TWO_SIDED|95.0|1.2264|5.3076|||ANCOVA|||Null hypothesis (H0) = mean increase of HDL after 24 weeks of treatment of Pio/Met group ≤ the mean increase in the Gli/Met group. Alternate hypothesis (H1) = mean increase of HDL after 24 weeks of treatment of Pio/Met group \> the mean increase in the Gli/Met group. The relevant clinical effect size to detect with adequate power was 0.35. With this assumption, a one sided t-test with a type I error rate had 80% power to reject the H0 for the H1 when the sample size was 130 patients per group.||5.3076|1.2264|0.0018
74065504|NCT00528879|147683386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.7||||0.0062||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0062
73883095|NCT00770653|147300186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267||||0.0018|TWO_SIDED|95.0|1.2264|5.3076|||ANCOVA||Deviation from the normal distribution assumption was detected for original and rank-transformed data for all time-points due to p-value of Shapiro-Wilk test, indicating the normal distribution assumption might be distrusted for HDL-cholesterol data.|||5.3076|1.2264|0.0018
74065505|NCT00528879|147683387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.3515||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
74065506|NCT00528879|147683387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.3022||0.0068||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0068
74065507|NCT00528879|147683387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.3535||0.029||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0290
73883096|NCT00770653|147300187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1311||||0.1167|TWO_SIDED|95.0|-0.2951|0.0329|||ANCOVA|||||0.0329|-0.2951|0.1167
73883097|NCT00770653|147300188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9479||||0.1012|TWO_SIDED|95.0|-39.4331|3.5373|||ANCOVA|||||3.5373|-39.4331|0.1012
73883098|NCT00770653|147300189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1292||||0.7486|TWO_SIDED|95.0|-17.0109|23.2693|||ANCOVA|||||23.2693|-17.0109|0.7486
73883099|NCT00770653|147300190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2355||||0.9464|TWO_SIDED|95.0|-7.1253|6.6543|||ANCOVA|||||6.6543|-7.1253|0.9464
73883100|NCT00770653|147300191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1574||||0.0807|TWO_SIDED|95.0|-0.0193|0.3341|||ANCOVA|||||0.3341|-0.0193|0.0807
73883101|NCT00770653|147300192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5039|||<|0.0001|TWO_SIDED|95.0|-6.4222|-2.5855|||ANCOVA|||||-2.5855|-6.4222|<.0001
73883102|NCT00770653|147300193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0707||||0.7799|TWO_SIDED|95.0|-6.4665|8.6079|||ANCOVA|||||8.6079|-6.4665|0.7799
73883103|NCT00770653|147300194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3161|||<|0.0001|TWO_SIDED|95.0|5.0994|7.5329|||ANCOVA|||||7.5329|5.0994|<.0001
73883104|NCT00770653|147300195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8323||||0.4131|TWO_SIDED|95.0|-2.8312|1.1665|||ANCOVA|||||1.1665|-2.8312|0.4131
73883105|NCT00770653|147300196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8847|||<|0.0001|TWO_SIDED|95.0|-1.3067|-0.4627|||ANCOVA|||||-0.4627|-1.3067|<.0001
74065508|NCT00528879|147683388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.3681||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
74065509|NCT00528879|147683388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|0.3745|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
74065510|NCT00528879|147683388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.3791|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
74065511|NCT00528879|147683395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1109||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
74065512|NCT00528879|147683395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1129||0.0004||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0004
74065513|NCT00528879|147683395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1146|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
74065514|NCT00528879|147683396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|2.769||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
74065515|NCT00528879|147683396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.762|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
74065516|NCT00528879|147683396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.7|STANDARD_ERROR_OF_MEAN|2.808|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
74065517|NCT00528879|147683397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|Modified logistic regression|||||||
74065518|NCT00528879|147683397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.8627|||||||Modified logistic regression|||||||0.8627
74065519|NCT00528879|147683397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3||||0.0149||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0149
74065520|NCT04133519|147683398|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5352|TWO_SIDED|95.0|0.73|1.84||P value from Cochran-Mantel-Haenszel testing of H0: OR=1; H1: OR≠1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel|||P value from Cochran-Mantel-Haenszel testing of H0: OR=1; H1: OR≠1 adjusting for IBS subtype and gender||1.84|0.73|0.5352
74065521|NCT04133519|147683398|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0232|TWO_SIDED|95.0|1.08|2.87|||Cochran-Mantel-Haenszel||Odds ratio reflects the odds of the number of GDH responders being greater than the number of MR responders for abdominal pain intensity.|The final 4 weeks of the on-treatment period (weeks 9-12) was a pre-specified period for analysis of the primary endpoint measure of abdominal pain due to IBS. An abdominal pain intensity responder was defined as a participant whose daily abdominal pain intensity averaged over the last 4 weeks of phase s (weeks 9 through 12) was at least 30% reduced compared with the daily abdominal pain intensity averaged over the 4 weeks of phase 1.||2.87|1.08|0.0232
74065522|NCT04133519|147683398|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0254|TWO_SIDED|95.0|1.07|2.89||P-value from Cochran-Mantel-Haenszel Test testing H0: OR=1; H1: OR\<\>1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel||Odds ratio reflects the odds of GDH being superior to MR.|"Abdominal pain scores were averaged each week on treatment (1-12) and compared with the average baseline abdominal pain score. Participants that recorded a \> 30% decrease in abdominal pain in at least half the weeks on treatment were considered responders.~This analysis was specified in FDA Guidance for Industry, Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment, May 2012. Both the analysis period and the responder threshold (30%) are specified by the FDA Guidance."|Among all subjects, 64.0% reported Adequate Relief and 67.7% reported overall satisfaction with Regulora.|2.89|1.07|0.0254
74065523|NCT04133519|147683399|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.8115|TWO_SIDED|95.0|-0.434|0.554|||ANOVA|||The least square (LS) mean difference between the GDH and MR groups using an analysis of variance (ANOVA) model||0.554|-0.434|0.8115
74065524|NCT04133519|147683400|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.7564|TWO_SIDED|95.0|-0.236|0.325|||ANOVA|||Average abdominal pain frequency at Week 13-16 will be statistically compared between GDH and comparator using an ANOVA model adjusted for gender and IBS subtype. The daily pain frequency measurement was derived from the daily pain intensity measurement. Days where severity was \>0 were considered a day with pain and were recorded as positive. Days with a score of 0 were days without pain. Mean represents the mean number of days in each time period with abdominal pain.||0.325|-0.236|0.7564
74065525|NCT04133519|147683401|SUPERIORITY||Odds Ratio (OR)|1.17||||0.4753|TWO_SIDED|95.0|0.76|1.81||P-value from Cochran-Mantel-Haenszel Test testing H0: OR=1; H1: OR\<\>1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel||GDH:MR Relative Risk|A Stool Consistency Responder is defined as a \>=30% improvement in the proportion of Bristol Stool Form Scale (BSFS) scores that fall within Group 2 (normal stools)||1.81|0.76|0.4753
74065526|NCT04133519|147683402|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.6793|TWO_SIDED|95.0|-0.301|0.46|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-C participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period."||0.460|-0.301|0.6793
74065527|NCT04133519|147683402|SUPERIORITY||Mean Difference (Final Values)|0.173||||0.9468|TWO_SIDED|95.0|-4.904|5.249|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-D participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period."||5.249|-4.904|0.9468
73883106|NCT00770653|147300197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4903||||0.0929|TWO_SIDED|95.0|-5.3979|0.4172|||ANCOVA|||||0.4172|-5.3979|0.0929
73883107|NCT00770653|147300198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8832||||0.3279|TWO_SIDED|95.0|-2.6571|0.8906|||ANCOVA|||||0.8906|-2.6571|0.3279
74065528|NCT04133519|147683403|SUPERIORITY||Median Difference (Final Values)|-1.602||||0.5015|TWO_SIDED|95.0|-6.282|3.077|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random The unstructured covariance matrix was used to model the within-participant correlation. The model-based least square (LS) means and LS mean differences (GDH minus comparator) and associated 95% CIs for each week and overall were estimated."||3.077|-6.282|0.5015
73888294|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|114.1||||0.005|TWO_SIDED|95.0|35.0|193.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||193.2|35.0|0.0050
74065529|NCT04133519|147683404|SUPERIORITY||Mean Difference (Final Values)|4.586||||0.2117|TWO_SIDED|95.0|-2.619|11.79|||Mixed Models Analysis|||"Percent Overall Work Impairment Due to IBS defined as the percent time missed by not showing up for work, plus the percent time missed while working, and calculated as: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]."||11.790|-2.619|0.2117
74065530|NCT04133519|147683405|SUPERIORITY||Mean Difference (Net)|2.372||||0.3676|TWO_SIDED|95.0|-2.793|7.537|||Mixed Models Analysis|||The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model: parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random||7.537|-2.793|0.3676
74065531|NCT00575328|147683412|SUPERIORITY|Analysis is a test of statistical significance to evaluate whether the results are consistent with the assumption of there being no difference in the clinical improvement (i.e. change in ASEX score) of the two treatments (null hypothesis).|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|3.3||0.62|TWO_SIDED|95.0|-8.7|12.3||No adjustment for multiple comparisons. P value for significance set a priori at P\<0.05.|t-test, 2 sided|||Null hypothesis: There will be no difference in clinical improvement (i.e. change in ASEX score) between treatment arms. No formal power analysis was carried out, given the small study sample.|The analysis is not truly informative, since the analyzable sample (n=6) was too small. Results should be viewed with caution.|12.3|-8.7|0.62
74065532|NCT00575328|147683413|SUPERIORITY|Analysis is a test of statistical significance to evaluate whether the results are consistent with the assumption of there being no difference in the clinical improvement (i.e. change in MGH-SD score) of the two treatments (null hypothesis).|Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|4.5||0.38|TWO_SIDED|95.0|-6.7|13.97||No adjustment for multiple comparisons. P value for significance set a priori at P\<0.05.|t-test, 2 sided|||Null hypothesis: There will be no difference in clinical improvement (i.e. change in MGH-SD score) between treatment arms. No formal power analysis was carried out, given the small study sample.|Analysis was not truly informative since the analyzable sample (n=6) was too small. Results should be interpreted with caution.|13.97|-6.7|0.38
74065533|NCT02522949|147683423|SUPERIORITY|||||||0.7146|||||||ANCOVA|||Oropharyngeal||||0.7146
74065534|NCT02522949|147683423|SUPERIORITY|||||||0.3543|||||||ANCOVA|||Nasal||||0.3543
74065535|NCT02522949|147683431|OTHER|||||||0.0232|||||||Exact Wilcoxon rank sum test|||||||0.0232
74065536|NCT02191579|147683451|SUPERIORITY||Odds Ratio (OR)|4.94|||<|0.001|TWO_SIDED|95.0|2.681|9.085||Odds ratio, 95% CI, and p-value were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic|||||9.085|2.681|<0.001
74065537|NCT02191579|147683452|SUPERIORITY||Mean Difference (Net)|-6.199|||<|0.001|TWO_SIDED|95.0|-7.936|-4.462||Estimated mean difference, 95% CI, and p-value were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA|||||-4.462|-7.936|<0.001
74065538|NCT02191579|147683453|SUPERIORITY||Median Difference (Net)|-4.248|||<|0.001||95.0|-5.766|-2.731||Estimated mean difference, 95% CI, and p-value for Week 30 were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA|||||-2.731|-5.766|<0.001
74065539|NCT02191579|147683454|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.001||95.0|2.014|8.157||Odds ratio, 95% CI, and p-value for the Week 29-32 interval were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic|||||8.157|2.014|<0.001
74065540|NCT04288115|147683562|NON_INFERIORITY|An one-sided α-level of 0.05 will be used to determine the statistical significance of the non-inferiority test.|Difference in Group Means|-5.3||||0.0913|TWO_SIDED|90.0|-16.1|5.4||Group differences.|Welch's two-sample t-test|A one-sided p-value \< 0.05 indicates the discontinuation mean falls within the non-inferiority limit.|Differences reported as the sham discontinuation mean minus the real discontinuation mean.|A one-sided t-test will be used to determine whether the mean Hypothyroid Symptoms score for the real discontinuation group is no more than 14 points worse than the score of the sham discontinuation group at 6 months.||5.4|-16.1|0.0913
74065541|NCT04288115|147683562|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical difference.|Difference in Group Means|0.8||||0.8793|TWO_SIDED|95.0|-9.4|10.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates the real discontinuation mean and the sham discontinuation mean are different. Adjusted for gender and baseline HSSs.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline hypothyroid symptom scores.|Analysis of 6-week outcome||10.9|-9.4|0.8793
74065542|NCT04288115|147683562|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-2.3||||0.686|TWO_SIDED|95.0|-14.0|9.3||Group differences.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline HSS.|Differences are reported as sham discontinuation mean minus real discontinuation mean. These differences have been adjusted for gender and baseline hypothyroid symptom scores.|Analysis of 6-month outcome||9.3|-14.0|0.6860
74065543|NCT04288115|147683563|NON_INFERIORITY|A one-sided α-level of 0.05 will be used to determine the statistical significance of the non-inferiority test.|Difference in Group Means|5.2||||0.0036|TWO_SIDED|90.0|-6.2|16.6||Group differences.|Welch's two-sample t-test|A one-sided p-value \< 0.05 indicates the discontinuation mean falls within the non-inferiority limit.|Differences reported as the sham discontinuation mean minus the real discontinuation mean.|A one-sided t-test will be used to determine whether the mean Tiredness score for the real discontinuation group is no more than 14 points worse than the score of the sham discontinuation group at 6 months.||16.6|-6.2|0.0036
74065544|NCT04288115|147683563|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|2.3||||0.7104|TWO_SIDED|95.0|-10.1|14.7||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These mean differences have been adjusted for gender and baseline tiredness score.|Analysis of 6-week outcome||14.7|-10.1|0.7104
74065545|NCT04288115|147683563|OTHER|A two-sided α-level of 0.05 will be used to determine statistical significance.|Difference in Group Means|5.4||||0.3381|TWO_SIDED|95.0|-5.9|16.7||Group differences.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as sham discontinuation mean minus real discontinuation mean. These differences have been adjusted for gender and baseline tiredness scores.|Analysis of 6-month outcome||16.7|-5.9|0.3381
74065546|NCT04288115|147683564|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-0.02||||0.4684|TWO_SIDED|95.0|-0.076|0.036||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D Descriptive scores.|Analysis of 6-week EQ-5D Descriptive score outcome.||0.036|-0.076|0.4684
74065547|NCT04288115|147683564|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|0.003||||0.9585|TWO_SIDED|95.0|-0.102|0.107||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D Descriptive scores.|Analysis of 6-month EQ-5D Descriptive score outcome.||0.107|-0.102|0.9585
74065548|NCT04288115|147683564|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|7.0||||0.0643|TWO_SIDED|95.0|-0.4|14.4||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D VAS scores.|Analysis of 6-week EQ-5D VAS score outcome.||14.4|-0.4|0.0643
74065549|NCT04288115|147683564|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-6.2||||0.1742|TWO_SIDED|95.0|-15.3|2.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline scores.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D VAS scores.|Analysis of 6-month EQ-5D VAS score outcome.||2.9|-15.3|0.1742
74065550|NCT04288115|147683565|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-12.0||||0.1695|TWO_SIDED|95.0|-29.3|5.3||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline total cholesterol value.|Analysis of 6-month total cholesterol outcome.||5.3|-29.3|0.1695
74065551|NCT04288115|147683565|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-6.8||||0.3805|TWO_SIDED|95.0|-22.2|8.6||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline LDL values.|Analysis of 6-month LDL outcome.||8.6|-22.2|0.3805
74065552|NCT04288115|147683565|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|1.7||||0.5724|TWO_SIDED|95.0|-4.44|7.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline HDL values.|Analysis of 6-month HDL outcome.||7.9|-4.44|0.5724
74065553|NCT04288115|147683565|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-17.8||||0.3939|TWO_SIDED|95.0|-59.4|23.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline triglyceride values.|Analysis of 6-month triglyceride outcome.||23.9|-59.4|0.3939
74065554|NCT00931385|147683608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.183|0.113|<0.0001
74065555|NCT00931385|147683608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.183|0.113|<0.0001
74065556|NCT00931385|147683608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.106|0.177|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.177|0.106|<0.0001
74065557|NCT00931385|147683609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.146|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.146|0.073|<0.0001
74065558|NCT00931385|147683609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.091|0.164|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.164|0.091|<0.0001
74065559|NCT00931385|147683609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.209|0.135|<0.0001
74065560|NCT00931385|147683610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.094|0.163|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.163|0.094|<0.0001
74065561|NCT00931385|147683610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.103|0.172|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.172|0.103|<0.0001
74065562|NCT00931385|147683610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.122|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.122|<0.0001
74065563|NCT00931385|147683611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.126|0.201|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.201|0.126|<0.0001
74065564|NCT00931385|147683611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.127|0.202|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.202|0.127|<0.0001
74065565|NCT00931385|147683611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.16|0.236|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.236|0.160|<0.0001
74065566|NCT00931385|147683612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.135|0.214|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.214|0.135|<0.0001
74065567|NCT00931385|147683612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.127|0.206|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.206|0.127|<0.0001
74065568|NCT00931385|147683612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.178|0.257|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.257|0.178|<0.0001
74065569|NCT00931385|147683613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.064|0.147|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.147|0.064|<0.0001
74065570|NCT00931385|147683613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.072|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.155|0.072|<0.0001
74065571|NCT00931385|147683613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.092|0.175|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.175|0.092|<0.0001
74065572|NCT00931385|147683614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.167|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.284|0.167|<0.0001
74065573|NCT00931385|147683614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.17|0.287|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.287|0.170|<0.0001
74065574|NCT00931385|147683614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.144|0.262|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.262|0.144|<0.0001
74065575|NCT00931385|147683615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.087|0.207|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.207|0.087|<0.0001
74065576|NCT00931385|147683615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.112|0.231|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.231|0.112|<0.0001
74065577|NCT00931385|147683615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.191|0.311|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.311|0.191|<0.0001
74065578|NCT00931385|147683616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.132|0.241|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.241|0.132|<0.0001
74065579|NCT00931385|147683616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.145|0.254|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.254|0.145|<0.0001
74065580|NCT00931385|147683616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.172|0.282|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.282|0.172|<0.0001
74065581|NCT00931385|147683617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.261|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.191|0.33|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.330|0.191|<0.0001
74065582|NCT00931385|147683617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.183|0.322|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.322|0.183|<0.0001
74065583|NCT00931385|147683617|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.232|0.372|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.372|0.232|<0.0001
74065584|NCT00931385|147683618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.087|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.221|0.087|<0.0001
74065585|NCT00931385|147683618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.086|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.221|0.086|<0.0001
74065586|NCT00931385|147683618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.115|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.250|0.115|<0.0001
74065587|NCT01364259|147683628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.175|TWO_SIDED||||||Fisher Exact||Our odds ratio is equal to 0\*5/9\*2 because we have a zero cell in the two by two table. Hence the OR = 0.|||||0.175
73883108|NCT00770653|147300199|SUPERIORITY_OR_OTHER||Fisher Exact|-3.33||||0.2895|TWO_SIDED|95.0|-14.83|8.39|||Fisher Exact|||The number and percentage of participants with a calculated compliance \>80% and \<120% are presented for both treatment groups. In addition, the p-values of Fisher's exact test, the two-sided 95% confidence intervals for the percentage of patients per treatment group and for the difference between the treatment groups are provided.||8.39|-14.83|0.2895
74065588|NCT04128696|147683651|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.973|TWO_SIDED|95.0|0.99|2.29||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.29|0.99|0.973
74065589|NCT04128696|147683652|SUPERIORITY||Hazard Ratio (HR)|4.44|||>|0.999|TWO_SIDED|95.0|2.01|9.82||Nominal p-value was calculated based on the one-sided log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||9.82|2.01|>0.999
74065590|NCT04128696|147683653|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.989|TWO_SIDED|95.0|1.05|1.86||Nominal p-value was calculated based on the log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.86|1.05|0.989
74065591|NCT04128696|147683654|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.996|TWO_SIDED|95.0|1.1|1.99||Nominal p-value was calculated based on the log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx)||1.99|1.10|0.996
74065592|NCT04128696|147683655|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|0.98|2.43|||Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx)||2.43|0.98|
74065593|NCT04128696|147683656|SUPERIORITY||Hazard Ratio (HR)|1.59|||||TWO_SIDED|95.0|1.0|2.53|||Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.53|1.00|
74065594|NCT04128696|147683661|OTHER||Difference in Percentage|-5.3|||||TWO_SIDED|95.0|-14.6|4.0||||||The comparison between the treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||4.0|-14.6|
74065595|NCT04128696|147683662|OTHER||Difference in Percentage|-13.3|||||TWO_SIDED|95.0|-27.8|1.5||||||The comparison between the treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.5|-27.8|
74065596|NCT04128696|147683663|OTHER||Difference in Percentage|-11.8|||||TWO_SIDED|95.0|-22.4|-1.1||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||-1.1|-22.4|
74065597|NCT04128696|147683664|OTHER||Difference in Percentage|-18.0|||||TWO_SIDED|95.0|-33.7|-1.4||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||-1.4|-33.7|
73883109|NCT00770653|147300200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.9516||||0.3517|TWO_SIDED|95.0|-94.1999|34.2967|||ANCOVA|||||34.2967|-94.1999|0.3517
74065598|NCT04128696|147683673|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.783|TWO_SIDED|95.0|0.78|1.77||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.77|0.78|0.783
74065599|NCT04128696|147683674|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5|TWO_SIDED|95.0|0.5|2.0||Nominal p-value was calculated based on the log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.00|0.50|0.500
74065600|NCT04128696|147683675|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.329|TWO_SIDED|95.0|0.62|1.34||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.34|0.62|0.329
74065601|NCT04128696|147683676|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.608|TWO_SIDED|95.0|0.6|2.0||Nominal p-value was calculated based on the one-sided log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.00|0.60|0.608
74065602|NCT01010230|147683679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.69|TWO_SIDED|95.0|-5.59|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.11|-5.59|0.69
74065603|NCT01010230|147683680|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.18||||0.18|TWO_SIDED|95.0|0.0|0.35||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.35|0.00|0.18
74065604|NCT01010230|147683681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.85|TWO_SIDED|95.0|-6.93|9.25||The threshold for significance was established a priori at alpha=0.05|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||9.25|-6.93|0.85
74065605|NCT01010230|147683682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19||||0.12|TWO_SIDED|95.0|0.43|5.95||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||5.95|0.43|0.12
73883110|NCT00770653|147300201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-151.4477||||0.1979|TWO_SIDED|95.0|-386.2256|83.3302|||ANCOVA|||||83.3302|-386.2256|0.1979
73883111|NCT00770653|147300202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.8589||||0.7186|TWO_SIDED|95.0|-163.3229|113.6052|||ANCOVA|||||113.6052|-163.3229|0.7186
73883112|NCT00770653|147300203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9728||||0.5058|TWO_SIDED|95.0|-39.9915|20.0459|||ANCOVA|||||20.0459|-39.9915|0.5058
73883113|NCT00770653|147300204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.3988||||0.523|TWO_SIDED|95.0|-60.7193|117.5169|||ANCOVA|||||117.5169|-60.7193|0.5230
73883114|NCT00770653|147300205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-367.2639||||0.2203|TWO_SIDED|95.0|-964.3923|229.8646|||ANCOVA|||||229.8646|-964.3923|0.2203
73883115|NCT00770653|147300206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0794||||0.585|TWO_SIDED|95.0|-95.6468|151.8057|||ANCOVA|||||151.8057|-95.6468|0.5850
73883116|NCT00770653|147300207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4205||||0.0138|TWO_SIDED|95.0|-4.3207|-0.5202|||ANCOVA|||||-0.5202|-4.3207|0.0138
73883117|NCT00770653|147300208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0009||||0.0817|TWO_SIDED|95.0|-30.1139|1.8578|||ANCOVA|||||1.8578|-30.1139|0.0817
74065606|NCT01010230|147683683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.97|TWO_SIDED|95.0|-4.24|4.05||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage (from general linear model).||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||4.05|-4.24|0.97
73883118|NCT00770653|147300209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9935||||0.1761|TWO_SIDED|95.0|-0.4843|2.4712|||ANCOVA|||||2.4712|-0.4843|0.1761
74065607|NCT01010230|147683684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.91|TWO_SIDED|95.0|-4.05|4.68||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||4.68|-4.05|0.91
74065608|NCT01010230|147683685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.4|TWO_SIDED|95.0|-0.69|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.11|-0.69|0.40
74065609|NCT01010230|147683686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.73|TWO_SIDED|95.0|-2.02|3.33||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.33|-2.02|0.73
73883119|NCT00770653|147300210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5263||||0.0002|TWO_SIDED|95.0|1.3832|3.6695|||ANCOVA|||||3.6695|1.3832|0.0002
73883120|NCT00770653|147300211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2345||||0.0055|TWO_SIDED|95.0|1.0675|5.4016|||ANCOVA|||||5.4016|1.0675|0.0055
73883121|NCT00770653|147300212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9712||||0.0264|TWO_SIDED|95.0|0.3863|5.5562|||ANCOVA|||||5.5562|0.3863|0.0264
73883122|NCT00770653|147300213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5394||||0.0509|TWO_SIDED|95.0|-0.0114|5.0901|||ANCOVA|||||5.0901|-0.0114|0.0509
73883123|NCT00770653|147300214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1718||||0.1013|TWO_SIDED|95.0|-0.466|4.8097|||ANCOVA|||||4.8097|-0.4660|0.1013
73883124|NCT00770653|147300215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1346||||0.1363|TWO_SIDED|95.0|-0.7338|5.0031|||ANCOVA|||||5.0031|-0.7338|0.1363
73883125|NCT00770653|147300216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4181||||0.1165|TWO_SIDED|95.0|-0.6561|5.4922|||ANCOVA|||||5.4922|-0.6561|0.1165
73883126|NCT04906499|147300224|OTHER||Cohen's d effect size|0.13|||||TWO_SIDED|95.0|-0.68|0.93||||||||0.93|-0.68|
73883127|NCT04906499|147300226|OTHER||Cohen's d effect size|0.42|||||TWO_SIDED|95.0|-0.44|1.24||||||||1.24|-0.44|
73883128|NCT04906499|147300228|OTHER||Cohen's d effect size|0.85|||||TWO_SIDED|95.0|-0.13|1.77||||||||1.77|-0.13|
73883129|NCT04906499|147300230|OTHER||Cohen's d effect size|0.97|||||TWO_SIDED|95.0|-0.05|1.93||||||||1.93|-0.05|
73883130|NCT04906499|147300232|OTHER||Pearson's r Correlation Coefficient|0.32|||||TWO_SIDED|95.0|-0.67|0.9||||||||0.90|-0.67|
73883131|NCT04906499|147300233|OTHER||Pearson's r Correlation Coefficient|0.55|||||TWO_SIDED|95.0|-0.48|0.94||||||||0.94|-0.48|
73883132|NCT04906499|147300234|OTHER||Pearson's r Correlation Coefficient|0.23|||||TWO_SIDED|95.0|-0.88|0.71||||||||0.71|-0.88|
73883133|NCT04906499|147300235|OTHER||Pearson's r Correlation Coefficient|-0.19|||||TWO_SIDED|95.0|-0.87|0.73||||||||0.73|-0.87|
73883134|NCT04906499|147300237|OTHER||Cohen's d effect size|-0.42|||||TWO_SIDED|95.0|-1.24|0.44||||||||0.44|-1.24|
73883135|NCT00179621|147300240|SUPERIORITY_OR_OTHER||||||<|0.001||||||To compare the response rates of Lenalidomide 5 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
73883136|NCT00179621|147300240|SUPERIORITY_OR_OTHER||||||<|0.001||||||To compare the response rates of Lenalidomide 10 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
73883137|NCT00179621|147300241|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
73883138|NCT00179621|147300241|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
73883139|NCT00179621|147300251|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
73883140|NCT00179621|147300251|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
73883141|NCT00179621|147300252|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||ANOVA|||||||0.054
73883142|NCT00179621|147300252|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.080
73883143|NCT00179621|147300253|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||ANOVA|||||||0.062
73883144|NCT00179621|147300253|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||ANOVA|||||||0.113
73883145|NCT02722564|147300256|OTHER||||||<|0.001||||||p value associated with the change between estimated and actual BrAC when the participants BrAC was ascending to 0.1.|t-test, 2 sided|||||||<0.001
73883146|NCT02722564|147300256|OTHER||||||<|0.0001||||||p value associated with change between estimated and actual BrAC as participants BrAC descended to 0.08.|t-test, 2 sided|||||||<0.0001
73883147|NCT01841281|147300300|OTHER|||||||0.78||||||The p-value is for the interaction term|testing for interaction term|||||||0.78
74065610|NCT01010230|147683687|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.2||||0.08|TWO_SIDED|95.0|0.06|0.34||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.34|0.06|0.08
74065611|NCT01010230|147683688|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.13||||0.17|TWO_SIDED|95.0|0.0|0.26||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.26|0.00|0.17
74065612|NCT01010230|147683689|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.08||||0.38|TWO_SIDED|95.0|-0.04|0.2||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.20|-0.04|0.38
74065613|NCT01010230|147683690|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|-0.02||||0.88|TWO_SIDED|95.0|-0.22|0.18||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.18|-0.22|0.88
74065614|NCT01010230|147683691|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.28||||0.06|TWO_SIDED|95.0|0.09|0.46||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.46|0.09|0.06
74065615|NCT00951899|147683700|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||A P value \< 0.05 was considered statistically significant|t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Colesevelam subjects||||0.0006
74065616|NCT00951899|147683700|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Placebo subjects||||0.30
74065617|NCT02046369|147683720|SUPERIORITY|The primary efficacy endpoint (the change from baseline in CDRS-R total score at Week 6)will be analyzed using a likelihood-based mixed model for repeated measures (MMRM).The response (dependent) variable is the change from baseline in CDRS-R total score assessed weekly (Weeks 1 to 6).The MMRM model includes fixed effects terms for treatment, visit (as a categorical variable), pooled country, age stratum (stratification factor, CDRS-R total score at baseline, and treatment-by-visit interaction.|LS mean differnce (SE)|-5.7|STANDARD_ERROR_OF_MEAN|1.39|<|0.0001|TWO_SIDED|95.0|-8.4|-3.0|||LS mean differnece (SE)|||A mean difference in change from Baseline in CDRS-R total score of 5.0 units was assumed for the lurasidone 20-80 mg/day arm over the placebo arm, and a common standard deviation of 14.2 units (effect size=0.35), a sample size of 145 subjects per treatment arm was calculated to yield a power of 85%. With an expected attrition rate of 15%, approximately 170 subjects per treatment arm (340 in total) were to be randomized in a 1:1 ratio .||-3.0|-8.4|<0.0001
74065618|NCT02046369|147683721|SUPERIORITY||LS mean differnce (SE)|-1.1|STANDARD_ERROR_OF_MEAN|0.54||0.0385|TWO_SIDED|95.0|-2.2|-0.1|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.1|-2.2|0.0385
74065619|NCT02046369|147683722|SUPERIORITY||LS mean differnce (SE)|3.9|STANDARD_ERROR_OF_MEAN|1.35||0.0044|TWO_SIDED|95.0|1.2|6.5|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||6.5|1.2|0.0044
74065620|NCT02046369|147683723|SUPERIORITY||LS mean differnce (SE)|4.7|STANDARD_ERROR_OF_MEAN|1.19|<|0.0001|TWO_SIDED|95.0|2.4|7.0|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||7.0|2.4|<0.0001
74065621|NCT02046369|147683724|SUPERIORITY||LS mean differnce (SE)|-0.7|STANDARD_ERROR_OF_MEAN|0.77||0.3715|TWO_SIDED|95.0|-2.2|0.8|||ANCOVA|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||0.8|-2.2|0.3715
74065622|NCT02046369|147683725|SUPERIORITY||LS mean differnce (SE)|-0.44|STANDARD_ERROR_OF_MEAN|0.112|<|0.0001|TWO_SIDED|95.0|-0.66|-0.22||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|LS mean differnece (SE)|||||-0.22|-0.66|<0.0001
74065623|NCT04444752|147683762|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gate-keeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared to placebo group in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical signficance at p=0.05 level was not achieved.|Mean Difference (Final Values)|23.36|STANDARD_ERROR_OF_MEAN|6.794||0.0007|TWO_SIDED|||||Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg dose Q2W 3. 300 mg dose Q4W vs placebo|ANCOVA|The data were analyzed using an ANCOVA model adjusted for treatment, baseline vIGA (moderate, severe), and baseline EASI.||"The primary efficacy analysis includes comparison of percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q2W regimen vs placebo.~The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0007
73883148|NCT01841281|147300301|OTHER|||||||0.09||||||The p-value is for the interaction term|testing for interaction term|||The treatment effect was tested as an interaction term between treatment and FeNO. The null hypothesis is the effect of treatment is stratified by the FeNO status. We used a regression model instead of t-test or Wilcoxon signed-rank test in order to control period and carry-over effect which is common in a cross-over study design||||0.09
74065624|NCT04444752|147683762|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with the placebo group in order from the highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at 0.05 level was not achieved.|Mean Difference (Final Values)|17.89|STANDARD_ERROR_OF_MEAN|6.537||0.0067|TWO_SIDED|||||Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.|ANCOVA|The data were analyzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI.||"The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 150 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0067
74065625|NCT04444752|147683762|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with placebo in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at the 0.05 level was not achieved.|Mean Difference (Final Values)|23.83|STANDARD_ERROR_OF_MEAN|6.575||0.0004|TWO_SIDED|||||Adjusted for mulitplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.|ANCOVA|The data were anlayzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI||"The efficacy analysis includes comparing percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q4W regimen vs placebo.~The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 300 Q4W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0004
74065626|NCT04444752|147683763|SUPERIORITY|The secondary efficacy analysis includes comparison of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16 for each CBP-201 300 mg Q2W vs placebo.|Difference in vIGA Response Rate|28.1||||0.0089|TWO_SIDED|||||There were no adjustments for multiple comparisons. For IGA response, counts, percentage, and 95% CIs obtained using the Clopper-Pearson method and were presented for pairwise comparisons for each CBP-201 group vs. placebo.|Chi-squared|||Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16.||||0.0089
74065627|NCT02557672|147683765|SUPERIORITY||Ratio of the Geometric Means|0.98||||0.84|TWO_SIDED|95.0|0.81|1.19|||Regression, Linear|||||1.19|0.81|0.84
74065628|NCT02557672|147683766|SUPERIORITY||Odds Ratio (OR)|0.49||||0.09|TWO_SIDED|95.0|0.22|1.11|||Regression, Logistic|||||1.11|0.22|0.09
74065629|NCT02557672|147683767|SUPERIORITY||Odds Ratio, log|0.76||||0.51|TWO_SIDED|95.0|0.33|1.73|||Regression, Logistic|||||1.73|0.33|0.51
74065630|NCT02557672|147683768|SUPERIORITY||Odds Ratio (OR)|1.39||||0.53|TWO_SIDED|95.0|0.51|3.79|||Regression, Logistic|||||3.79|0.51|0.53
74065631|NCT02557672|147683769|SUPERIORITY||Odds Ratio (OR)|0.52||||0.39|TWO_SIDED|95.0|0.12|2.3|||Regression, Logistic|||||2.30|0.12|0.39
74065632|NCT03705169|147683771|EQUIVALENCE|Confidence Interval (CI) on Geometric Mean Ratio.|Geometric Mean Ratio|3.2|||||TWO_SIDED|95.0|1.9|5.3|||||The ratios of the geometric means (Arm A/Arm C) and the corresponding 95% CI were obtained by exponentiating the least squares mean difference and its 95% CI of the natural log-transformed data.|As dose-normalized AUC 0-12WK values were considered, participants were pooled within Arm (i.e., Arm A participants receiving 1, 3, 10, or 30 mg/kg were pooled and Arm C participants 0.3 or 1.0 mg/kg were pooled).|No comparisons were done with Arm B participants, as only two participants in that arm had available measurements such that AUC 0-12WK could be estimated.|5.3|1.9|
74065633|NCT03705169|147683772|OTHER||Mean|-0.18||||0.26|TWO_SIDED|95.0|-0.53|0.18||Under the null hypothesis, it was assumed there was no change in HIV-1 RNA (log10 copies/mL) from baseline to Day 7 of SAR441236 monotherapy for viremic participants with HIV (Arm B cohorts).|t-test, 2 sided|||Arm B participants were pooled across doses for analysis.||0.18|-0.53|0.26
74065634|NCT03705169|147683774|OTHER||Mean|-0.02||||0.78|TWO_SIDED|95.0|-0.24|0.19||Under the null hypothesis, it was assumed there was no change in HIV-1 RNA (log10 copies/mL) from baseline to Day 14 of SAR441236 monotherapy for viremic participants with HIV (Arm B cohorts).|t-test, 2 sided|||Arm B participants were pooled across doses for analysis.||0.19|-0.24|0.78
74065635|NCT00420290|147683795|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||0.031 is the upper level of significance|ANCOVA|||Using data from 128 CHD patients, CRP data were highly skewed, and data were log transformed to achieve normality. With 14 pts in each group (total of 28), it was predicted the minimum detectable difference between control and intervention would be 15% (1.22 for control group and 1.00 for the intervention group), with an 80% power and an alpha of 0.05 using t test approach. Thus, planned sample size was 30 to complete the study.||||0.008
74065636|NCT00420290|147683796|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||||||0.03
74065637|NCT00420290|147683797|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74065638|NCT00420290|147683798|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74065639|NCT00420290|147683799|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74065640|NCT03877237|147683800|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|4.23||||0.02164|TWO_SIDED|95.0|0.96|8.22||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint KCCQ-TSS, the following hypothesis was tested using the significance level 0.04990~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-TSS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||8.22|0.96|0.02164
74065641|NCT03877237|147683801|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|4.17||||0.05842|TWO_SIDED|95.0|0.03|8.33||KCCQ-PLS was tested at the alpha level of 0.04990 because KCCQ-TSS had a statistically significant p-value, in accordance with the pre-specified testing strategy.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint KCCQ-PLS, the following hypothesis was tested at significant level of 0.04990~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-PLS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||8.33|0.03|0.05842
74065642|NCT03877237|147683802|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.2||||0.68626|TWO_SIDED|95.0|-6.5|13.0||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint 6MWD, the following hypothesis was tested using the significance level 0.00010:~H0: m(r(A)) = m(r(C)) versus H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, 6MWD, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||13.0|-6.5|0.68626
74065643|NCT03877237|147683803|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|-0.16||||0.19748|TWO_SIDED|95.0|-0.55|0.22||Total time spent in LVPA was not tested for statistical significance and the p-value is considered nominal because the test for 6MWD was not statistically significant.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the secondary efficacy endpoint, total time spent in LVPA, the testing hypothesis is~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in secondary efficacy endpoint, total time spent in LVPA, from baseline to End of study among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||0.22|-0.55|0.19748
74065644|NCT00382291|147683828|SUPERIORITY_OR_OTHER|||||||0.2106||95.0|||||Kruskal-Wallis|||Data were analyzed using two-sided Kruskal-Wallis test with level of significance = .05. Null hypothesis was that there were no group differences. The maximum CGI-SA obtained over course of study was the outcome measure.||||.2106
74065645|NCT00382291|147683829|SUPERIORITY_OR_OTHER|||||||0.8831|TWO_SIDED|95.0|||||ANCOVA|||Data were analyzed using ANCOVA modeling with two-sided testing and level of significance = .05. The dependent variable was last measured CY-BOCS score, the independent variable was randomized group assignment and the covariate was the CY-BOCS score at baseline. The null hypothesis was that there were no group differences.||||.8831
74065646|NCT02092961|147683834|SUPERIORITY_OR_OTHER||Treatment difference|-1.75||||0.022|TWO_SIDED|90.0|-2.75|-0.42||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||-0.42|-2.75|0.022
73883149|NCT02891174|147300302|EQUIVALENCE|margin=10 mmHg|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-3.7|5.7|||||The adjusted mean difference between ibuprofen and acetaminophen is presented here. The adjusted mean difference was calculated using a linear mixed model adjusting for time period by intention-to-treat principles.|||5.7|-3.7|
73883150|NCT02891174|147300303|SUPERIORITY|||||||0.59||||||Abdominal pain|t-test, 2 sided|||Change in abdominal pain||||0.59
73883151|NCT02891174|147300303|SUPERIORITY|||||||0.91||||||Perineal pain|t-test, 2 sided|||Change in perineal pain||||0.91
74065647|NCT02092961|147683834|SUPERIORITY_OR_OTHER||Treatment difference|0.5||||0.402|TWO_SIDED|90.0|-1.0|2.0||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||2.00|-1.00|0.402
74065648|NCT02092961|147683835|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.746|TWO_SIDED|90.0|-1.0|0.5||A negative value for change from baseline in OMERACT RAMRIS osteitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.50|-1.00|0.746
74065649|NCT02092961|147683835|SUPERIORITY_OR_OTHER||Treatment difference|1.0||||0.413|TWO_SIDED|90.0|-1.5|3.5||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||3.50|-1.50|0.413
74065650|NCT02092961|147683836|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.491|TWO_SIDED|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.00|0.00|0.491
74065651|NCT02092961|147683836|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.341|TWO_SIDED|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||0.00|0.00|0.341
74065652|NCT02092961|147683837|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.366|TWO_SIDED|90.0|-0.5|0.0||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.00|-0.50|0.366
73883152|NCT02891174|147300303|SUPERIORITY|||||||0.88||||||Overall pain|t-test, 2 sided|||Change in overall pain||||0.88
73883153|NCT02891174|147300304|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
73883154|NCT02891174|147300305|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||First intervention (24 hours)||||0.02
73883155|NCT02891174|147300305|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Second intervention (24 hours)||||0.06
73883156|NCT02891174|147300305|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Overall satisfaction with pain control during study period||||0.04
73883157|NCT04516746|147300333|SUPERIORITY||Vaccine efficacy|73.98|||<|0.001|TWO_SIDED|95.0|65.34|80.47|||Poisson regression with robust variance|||The 95% confidence interval (CI) and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||80.47|65.34|<0.001
74065653|NCT02092961|147683837|SUPERIORITY_OR_OTHER||Treatment difference|1.25||||0.053|TWO_SIDED|90.0|0.5|2.5||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||2.50|0.50|0.053
74065654|NCT02092961|147683838|SUPERIORITY_OR_OTHER||Least Square Mean Treatment Difference|0.89||||0.006|TWO_SIDED|90.0|0.36|1.41|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 6. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.||1.41|0.36|0.006
74065655|NCT02092961|147683838|SUPERIORITY_OR_OTHER||Least Square Mean Treatment Difference|-0.34||||0.496|TWO_SIDED|90.0|-1.16|0.49|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 24. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.||0.49|-1.16|0.496
74065656|NCT03549130|147683868|SUPERIORITY||Least Square (LS) mean difference|-0.77||||0.2446|TWO_SIDED|95.0|-2.06|0.53||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||0.53|-2.06|0.2446
74065657|NCT03549130|147683868|SUPERIORITY||LS mean difference|-1.8||||0.0333|TWO_SIDED|95.0|-3.45|-0.14||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.||-0.14|-3.45|0.0333
74065658|NCT03549130|147683868|SUPERIORITY||LS mean difference|-1.63||||0.0345|TWO_SIDED|95.0|-3.13|-0.12||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.||-0.12|-3.13|0.0345
74065659|NCT03549130|147683868|SUPERIORITY||LS mean difference|-0.71||||0.1711|TWO_SIDED|95.0|-1.72|0.31||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.||0.31|-1.72|0.1711
74065660|NCT03549130|147683869|SUPERIORITY||LS mean difference|-0.47||||0.5063|TWO_SIDED|95.0|-1.85|0.92||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||0.92|-1.85|0.5063
74065661|NCT03549130|147683869|SUPERIORITY||LS mean difference|-0.97||||0.2496|TWO_SIDED|95.0|-2.64|0.69||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.||0.69|-2.64|0.2496
74065662|NCT03549130|147683869|SUPERIORITY||LS mean difference|-0.71||||0.3325|TWO_SIDED|95.0|-2.16|0.74||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.||0.74|-2.16|0.3325
74065663|NCT03549130|147683869|SUPERIORITY||LS mean difference|-0.81||||0.1088|TWO_SIDED|95.0|-1.81|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.||0.18|-1.81|0.1088
74065664|NCT03549130|147683870|SUPERIORITY||LS mean difference|-0.25||||0.2513|TWO_SIDED|95.0|-0.68|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.18|-0.68|0.2513
74065665|NCT03549130|147683870|SUPERIORITY||LS mean difference|-0.37||||0.0743|TWO_SIDED|95.0|-0.78|0.04||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.04|-0.78|0.0743
74065666|NCT03549130|147683870|SUPERIORITY||LS mean difference|-0.55||||0.0158|TWO_SIDED|95.0|-0.99|-0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||-0.10|-0.99|0.0158
74065667|NCT03549130|147683870|SUPERIORITY||LS mean difference|-0.47||||0.0489|TWO_SIDED|95.0|-0.94|0.0||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.00|-0.94|0.0489
74065668|NCT03549130|147683871|SUPERIORITY||LS mean difference|-0.19||||0.3034|TWO_SIDED|95.0|-0.57|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.18|-0.57|0.3034
74065669|NCT03549130|147683871|SUPERIORITY||LS mean difference|-0.15||||0.4891|TWO_SIDED|95.0|-0.57|0.27||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.27|-0.57|0.4891
74065670|NCT03549130|147683871|SUPERIORITY||LS mean difference|-0.01||||0.9498|TWO_SIDED|95.0|-0.43|0.4||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.40|-0.43|0.9498
74065671|NCT03549130|147683871|SUPERIORITY||LS mean difference|-0.36||||0.1235|TWO_SIDED|95.0|-0.83|0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.10|-0.83|0.1235
74065672|NCT03549130|147683872|SUPERIORITY|||||||0.8498||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.8498
74065673|NCT03549130|147683872|SUPERIORITY|||||||0.4652||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.4652
74065674|NCT03549130|147683872|SUPERIORITY|||||||0.439||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.4390
74065675|NCT03549130|147683872|SUPERIORITY|||||||0.2997||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.2997
74065676|NCT03549130|147683872|SUPERIORITY|||||||0.1116||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.1116
74065677|NCT03549130|147683872|SUPERIORITY|||||||0.5101||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.5101
74065678|NCT03549130|147683872|SUPERIORITY|||||||0.474||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.4740
74065679|NCT03549130|147683872|SUPERIORITY|||||||0.2787||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.2787
74065680|NCT03549130|147683873|SUPERIORITY|||||||0.5958||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.5958
74065681|NCT03549130|147683873|SUPERIORITY|||||||0.7296||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.7296
74065682|NCT03549130|147683873|SUPERIORITY|||||||0.7171||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.7171
74065683|NCT03549130|147683873|SUPERIORITY|||||||0.403||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.4030
74065684|NCT03549130|147683873|SUPERIORITY|||||||0.4741||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.4741
74065685|NCT03549130|147683873|SUPERIORITY|||||||0.5591||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.5591
74065686|NCT03549130|147683873|SUPERIORITY|||||||0.8285||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.8285
74065687|NCT03549130|147683873|SUPERIORITY|||||||0.3487||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.3487
74065688|NCT01677910|147683883|SUPERIORITY||Mean Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-1.283|-0.337|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.||-0.337|-1.283|< 0.001
74065689|NCT01677910|147683883|SUPERIORITY||Mean Difference (Net)|-0.833|||<|0.001|TWO_SIDED|95.0|-1.292|-0.374|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.||-0.374|-1.292|< 0.001
74065690|NCT03341273|147683893|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-15.0|2.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D5V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D5V is 5.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||2|-15|
74065691|NCT03341273|147683894|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-12.0|3.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D11V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D11V is 11.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||3|-12|
74065692|NCT03341273|147683895|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-7.0|||||TWO_SIDED|95.0|-13.0|0.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D11V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D28V is 28.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||0|-13|
74065693|NCT03341273|147683896|SUPERIORITY|DOOR is a composite endpoint created using clinical outcomes from Day 1 through Day 5 Visit. It is based on adequate clinical improvement at Day 5 Visit and solicited events from Day 1 through Day 5 Visit.|Pr(Higher DOOR in Placebo at Day 5 Visit|0.63|||<|0.001|TWO_SIDED|95.0|0.57|0.68||Missing DOOR values at Day 5 Visit were first imputed using linear regression using baseline covariates and available DOOR components as covariates.|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value||Null: The sum of the probability that a participant assigned to placebo will have a higher DOOR at Day 5 visit than if assigned to the Azithromycin plus one-half the probability of equal DOORs at Day 5 Visit is 50% (i.e., no difference in DOOR at Day 5 Visit).||0.68|0.57|<0.001
74065694|NCT01717456|147683912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|6.72||0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons.|t-test, 2 sided|||||||.05
74065695|NCT02008721|147683944|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3,9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo treatment.~We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in motor examination scores on UMSARS between baseline and week 52 between the study groups."||||0.51
74065696|NCT02008721|147683945|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3,9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo treatment.~We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in motor examination scores on UMSARS between baseline and week 52 between the study groups."||||0.82
74065697|NCT02008721|147683946|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size. We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in UMSARS total score between baseline and week 52 between the study groups.~We did a post-hoc power calculation based on the mean change in motor examination scores on UMSARS and SDs in the placebo group of the per-protocol study completer set to test the assumptions of our initial power calculation."||||0.99
74065698|NCT02008721|147683947|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size. We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in UMSARS total score between baseline and week 52 between the study groups.~We did a post-hoc power calculation based on the mean change in motor examination scores on UMSARS and SDs in the placebo group of the per-protocol study completer set to test the assumptions of our initial power calculation."||||0.43
74065699|NCT03751020|147683976|SUPERIORITY||Mean Difference (Net)|-6.34|||<|0.01|TWO_SIDED|95.0|-11.03|-1.64|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||-1.64|-11.03|<0.01
74065700|NCT03751020|147683977|SUPERIORITY||Mean Difference (Net)|-0.33||||0.03|TWO_SIDED|95.0|-0.62|-0.03|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||-0.03|-0.62|0.03
74065701|NCT03751020|147683978|SUPERIORITY||Mean Difference (Net)|-4.03||||0.07|TWO_SIDED|95.0|-8.55|0.47|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||0.47|-8.55|0.07
74065702|NCT03751020|147683979|SUPERIORITY||Mean Difference (Net)|1.12||||0.73|TWO_SIDED|95.0|-6.48|8.77|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||8.77|-6.48|0.73
74065703|NCT03751020|147683980|SUPERIORITY||Mean Difference (Net)|-1.28||||0.1|TWO_SIDED|95.0|-2.8|0.24|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||0.24|-2.80|0.10
74065704|NCT03751020|147683981|SUPERIORITY||Mean Difference (Net)|0.09||||0.76|TWO_SIDED|95.0|-1.19|1.57|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||1.57|-1.19|0.76
74065705|NCT00711867|147684006|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as -0.5 C.|Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.14|||t-test, 2 sided|||H0: Mu\_VH - Mu\_BH \<= -0.5 C.||-0.14|-0.55|
74065706|NCT00078819|147684013|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
74065707|NCT00078819|147684014|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
74065708|NCT00078819|147684015|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
74065709|NCT00078819|147684016|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Van Elteren test|Two-sided van Elteren's test stratified by age group||||||<0.0001
74065710|NCT00078819|147684017|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
74065711|NCT00323609|147684020|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||Fisher Exact|||||||0.214
73883158|NCT04516746|147300337|SUPERIORITY||Vaccine efficacy|64.32|||<|0.001|TWO_SIDED|95.0|56.05|71.03|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||71.03|56.05|<0.001
73883159|NCT04516746|147300338|SUPERIORITY||Vaccine efficacy|69.65|||<|0.001|TWO_SIDED|95.0|60.68|76.57|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||76.57|60.68|<0.001
73883160|NCT04516746|147300339|SUPERIORITY||Vaccine efficacy|70.7|||<|0.001|TWO_SIDED|95.0|61.62|77.64|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||77.64|61.62|<0.001
73883161|NCT04516746|147300340|SUPERIORITY||Vaccine efficacy|73.68|||<|0.001|TWO_SIDED|95.0|65.13|80.13|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||80.13|65.13|<0.001
74065712|NCT00323609|147684021|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 7 days.||||0.430
74065713|NCT00323609|147684021|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.||||0.655
74065714|NCT00323609|147684021|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.756
74065715|NCT00323609|147684021|SUPERIORITY_OR_OTHER|||||||0.503||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.503
73883162|NCT04516746|147300341|SUPERIORITY||Vaccine efficacy|100.0|||<|0.001|ONE_SIDED|97.5|71.62||||Poisson regression exact conditional|||The exact 1-sided 97.5% CI and p-value were estimated based on stratified Poisson regression with exact conditional method (including study arm and stratification factor \[age group at informed consent\] as strata factor and log of total number of participants for each combination of study arm and strata as an offset).|||71.62|<0.001
73883163|NCT04516746|147300342|SUPERIORITY||Vaccine efficacy|84.97|||<|0.001|TWO_SIDED|95.0|58.97|94.5|||Poisson regression with robust variance|||The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).||94.50|58.97|<0.001
73883164|NCT04516746|147300343|SUPERIORITY||Vaccine efficacy|94.8||||0.005|TWO_SIDED|95.0|58.98|99.34|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||99.34|58.98|0.005
73883165|NCT04516746|147300350|SUPERIORITY||Vaccine efficacy|54.47|||||TWO_SIDED|95.0|46.48|61.26||||||The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).||61.26|46.48|
74065716|NCT00323609|147684021|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.837
74065717|NCT00323609|147684022|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days||||0.785
74065718|NCT00323609|147684022|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.393
74065719|NCT00323609|147684022|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months||||0.875
73888295|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|83.3||||0.0392|TWO_SIDED|95.0|4.2|162.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||162.4|4.2|0.0392
74065720|NCT00323609|147684022|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.833
74065721|NCT00323609|147684023|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 30 days.||||0.180
74065722|NCT00323609|147684023|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 3 months||||0.822
74065723|NCT00323609|147684023|SUPERIORITY_OR_OTHER|||||||0.291||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 12 months||||0.291
74065724|NCT00323609|147684023|SUPERIORITY_OR_OTHER|||||||0.996||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 24 months||||0.996
74065725|NCT00323609|147684023|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 30 days||||0.983
74065726|NCT00323609|147684023|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 3 months||||0.576
74065727|NCT00323609|147684023|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 12 months||||0.393
74065728|NCT00323609|147684023|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 24 months||||0.722
74065729|NCT00323609|147684024|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.||||0.318
74065730|NCT00323609|147684024|SUPERIORITY_OR_OTHER|||||||0.523||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.523
74065731|NCT00323609|147684024|SUPERIORITY_OR_OTHER|||||||0.634||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.634
74065732|NCT00323609|147684024|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.457
74065733|NCT00323609|147684025|SUPERIORITY_OR_OTHER|||||||0.818||95.0|||||Fisher Exact|||||||0.818
74065734|NCT00323609|147684026|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||||||0.226
74065735|NCT00323609|147684027|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
74065736|NCT00323609|147684028|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.112
74065737|NCT00323609|147684028|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.364
74065738|NCT00323609|147684028|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.185
74065739|NCT00323609|147684028|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.100
74065740|NCT00323609|147684029|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.005
74065741|NCT00323609|147684029|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.382
74065742|NCT00323609|147684029|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.196
74065743|NCT00323609|147684029|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.281
74065744|NCT00323609|147684030|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.033
74065745|NCT00323609|147684030|SUPERIORITY_OR_OTHER|||||||0.981||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.981
74065746|NCT00323609|147684030|SUPERIORITY_OR_OTHER|||||||0.631||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.631
74065747|NCT00323609|147684030|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.790
74065748|NCT00323609|147684031|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.663
74065749|NCT00323609|147684031|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.933
74065750|NCT00323609|147684031|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.089
74065751|NCT00323609|147684031|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.036
74065752|NCT00323609|147684032|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.472
74065753|NCT00323609|147684032|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.745
74065754|NCT00323609|147684032|SUPERIORITY_OR_OTHER|||||||0.565||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.565
74065755|NCT00323609|147684032|SUPERIORITY_OR_OTHER|||||||0.687||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.687
74065756|NCT00267293|147684035|NON_INFERIORITY_OR_EQUIVALENCE|Power for 80%|||||<|0.001||||||comparision of mean temperatures from repeated exposure. At hour 6 temperature|Mixed Models Analysis|||Power for 80%||||<0.001
74065757|NCT00267293|147684035|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Binary outcome \<38C and \>=38C|Chi-squared|||||||<.0001
73888296|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|68.7||||0.0883|TWO_SIDED|95.0|-10.4|147.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||147.8|-10.4|0.0883
73888297|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|64.4||||0.11|TWO_SIDED|95.0|-14.7|143.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||143.5|-14.7|0.1100
73888298|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|242.9|||<|0.0001|TWO_SIDED|95.0|138.6|347.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||347.2|138.6|<0.0001
74065758|NCT00950599|147684036|SUPERIORITY_OR_OTHER|||||||0.9888||95.0||||A significance level of alpha = 0.05 was used for the trend test.|Kruskal-Wallis|ANCOVA Model: post-pre=pre treatment.||A test for log-linear trend across saxagliptin doses was performed using a linear contrast among the saxagliptin doses from an analysis of covariance (ANCOVA) model. The ANCOVA model was the same model used for the first secondary endpoint.||||0.9888
74065759|NCT00950599|147684037|SUPERIORITY_OR_OTHER|||||||0.9888||95.0||||Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort.|ANCOVA|ANCOVA Model: post-pre=pretreatment. Contrast Coefficients: -2, -1, 0, 1 2.||||||0.9888
74065760|NCT00475852|147684138|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.7||||0.313|TWO_SIDED|95.0|-2.1|0.7|||Cochran-Mantel-Haenszel|Stratified by geographical region.||||0.7|-2.1|0.313
74065761|NCT00475852|147684139|SUPERIORITY_OR_OTHER|||||||0.03|||||||Van Elteren test|Controlled for region.||||||0.030
74065762|NCT00475852|147684140|SUPERIORITY_OR_OTHER|||||||0.007|||||||Van Elteren test|Controlled for region.||||||0.007
74065763|NCT00475852|147684141|SUPERIORITY_OR_OTHER|||||||0.318|||||||Van Elteren test|Controlled for region.||||||0.318
74065764|NCT00475852|147684142|SUPERIORITY_OR_OTHER|||||||0.018|||||||Van Elteren test|Controlled for region.||||||0.018
74065765|NCT00475852|147684143|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.5||||0.295|TWO_SIDED|95.0|-1.5|0.5|||Cochran-Mantel-Haenszel|Controlled for region.||||0.5|-1.5|0.295
74065766|NCT00475852|147684144|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.16|||||||ANOVA|Controlled for region.|This analysis excluded subjects who were lost to follow-up, or withdrawal of consent before Day 30, or whose Day 30 visit occurred prior to Day 30.|||||0.160
74065767|NCT00475852|147684145|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.9||||0.238|TWO_SIDED|95.0|-2.4|0.6|||Cochran-Mantel-Haenszel|Controlled for region.|For subjects with a Day 30 visit prior to Day 30, information from their Day 180 visit, if available, was used to impute the mortality and rehospitalization status at Day 30.|||0.6|-2.4|0.238
74065768|NCT00475852|147684149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.109|TWO_SIDED|95.0|0.98|1.21|||Cochran-Mantel-Haenszel|Controlled for region.||||1.21|0.98|0.109
74065769|NCT01361607|147684152|SUPERIORITY||Median Difference (Final Values)|-1.84||||0.2735|TWO_SIDED|95.0|-6.19|1.5|||Wilcoxon (Mann-Whitney)|||||1.50|-6.19|0.2735
74065770|NCT03979677|147684175|OTHER|HDI and DHI analyzed using linear mixed-effects models with two within-participant factors, Intervention (pre-intervention, post-intervention) and Inventory (DHI, HDI). All models included participant as a random factor. Models constructed using lmer function of the lme package in R and analyzed using anova function in base R. Significant main effects and interactions were evaluated using emmeans . Pairwise comparisons were adjusted to account for false-discovery rates.|||||<|0.0001||||||Multiple comparisons were adjusted.|linear mixed-effects models|||||||<.0001
74065771|NCT03979677|147684176|OTHER|HDI and DHI analyzed using linear mixed-effects models with two within-participant factors, Intervention (pre-intervention, post-intervention) and Inventory (DHI, HDI). All models included participant as a random factor. Models constructed using lmer function of the lme package in R and analyzed using anova function in base R. Significant main effects and interactions were evaluated using emmeans . Pairwise comparisons were adjusted to account for false-discovery rates.|||||<|0.0001||||||Point change in DHI was tests.|linear mixed-effects models|||||||<.0001
74065772|NCT02273206|147684177|SUPERIORITY|||||||0.2562|||||||Chi-squared|p\<0.05||Colorectal Cancer Screening Intervention Arm Difference||||0.2562
74065773|NCT02273206|147684177|SUPERIORITY|||||||0.9795|||||||Chi-squared|p\<0.05||Breast Cancer Screening Intervention Arm Difference||||0.9795
74065774|NCT02273206|147684177|SUPERIORITY|||||||0.3917|||||||Chi-squared|p\<0.05||Cervical Cancer Screening Intervention Arm Difference||||0.3917
74065775|NCT02273206|147684178|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|1.346||||0.0677|TWO_SIDED|95.0|0.979|1.851||Treatment Group (CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline colorectal cancer up to date status, age, and income.|||1.851|0.979|0.0677
74065776|NCT02273206|147684179|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|1.031||||0.8501|TWO_SIDED|95.0|0.753|1.41||Treatment Group (CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline breast cancer up to date status, age, and income|||1.410|0.753|0.8501
74065777|NCT02273206|147684180|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|0.876||||0.4432|TWO_SIDED|95.0|0.625|1.228||Treatment Group(CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline cervical cancer up to date status, age, and income.|||1.228|0.625|0.4432
74065778|NCT02273206|147684181|SUPERIORITY|||||||0.39|||||||Two-sample t-test|p\<0.05||PHQ9 Intervention Arm Difference between baseline and 12-month follow up||||0.39
74065779|NCT02273206|147684182|SUPERIORITY|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at baseline.||||0.60
74065780|NCT02273206|147684182|SUPERIORITY|||||||0.86|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 6 Months||||0.86
74065781|NCT02273206|147684183|SUPERIORITY|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at Baseline.||||0.60
74065782|NCT02273206|147684183|SUPERIORITY|||||||0.23|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 12 months.||||0.23
74065783|NCT02273206|147684184|SUPERIORITY|||||||0.4483|||||||Chi-squared|p\<0.05||Colorectal Cancer Screening Intervention Arm Difference at 12 Months||||0.4483
74065784|NCT02273206|147684184|SUPERIORITY|||||||0.1706|||||||Chi-squared|p\<0.05||Cervical Cancer Screening Intervention Arm Difference at 12 Months||||0.1706
73888299|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.0||||0.6906|TWO_SIDED|95.0|-125.3|83.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.2|-125.3|0.6906
74065785|NCT02273206|147684184|SUPERIORITY|||||||0.3568|||||||Chi-squared|p\<0.05||Breast Cancer Screening Intervention Arm Difference at 12 Months||||0.3568
74065786|NCT02273206|147684185|SUPERIORITY|||||||0.85|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at baseline.||||0.85
74065787|NCT02273206|147684185|SUPERIORITY|||||||0.23|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 6 months.||||0.23
74065788|NCT02273206|147684185|SUPERIORITY|||||||0.98|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 12 months.||||0.98
74065789|NCT02273206|147684185|SUPERIORITY|||||||0.57|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at baseline.||||0.57
74065790|NCT02273206|147684185|SUPERIORITY|||||||0.92|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 6 months.||||0.92
74065791|NCT02273206|147684185|SUPERIORITY|||||||0.99|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 12 months.||||0.99
74065792|NCT02273206|147684186|SUPERIORITY|||||||0.2|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at baseline.||||0.20
73888300|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|118.7||||0.0259|TWO_SIDED|95.0|14.5|223.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||223.0|14.5|0.0259
74065793|NCT02273206|147684186|SUPERIORITY|||||||0.17|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 6 months.||||0.17
74065794|NCT02273206|147684186|SUPERIORITY|||||||0.69|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 12 months.||||0.69
74065795|NCT02273206|147684186|SUPERIORITY|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at baseline.||||0.72
74065796|NCT02273206|147684186|SUPERIORITY|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 6 months.||||0.72
74065797|NCT02273206|147684186|SUPERIORITY|||||||0.87|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 12 months.||||0.87
74065798|NCT02273206|147684186|SUPERIORITY|||||||0.65|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at baseline.||||0.65
74065799|NCT02273206|147684186|SUPERIORITY|||||||0.82|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 6 months.||||0.82
74065800|NCT02273206|147684186|SUPERIORITY|||||||0.92|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 12 months.||||0.92
74065801|NCT02273206|147684186|SUPERIORITY|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months.||||0.56
74065802|NCT02273206|147684187|SUPERIORITY|||||||0.17|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at baseline.||||0.17
74065803|NCT02273206|147684187|SUPERIORITY|||||||0.38|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 6 months.||||0.38
74065804|NCT02273206|147684187|SUPERIORITY|||||||0.07|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 12 months.||||0.07
73888301|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|103.2||||0.0525|TWO_SIDED|95.0|-1.1|207.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||207.5|-1.1|0.0525
74065805|NCT02273206|147684187|SUPERIORITY|||||||0.99|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at baseline.||||0.99
74065806|NCT02273206|147684187|SUPERIORITY|||||||0.15|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 6 months.||||0.15
74065807|NCT02273206|147684187|SUPERIORITY|||||||0.55|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 12 months.||||0.55
74065808|NCT02273206|147684187|SUPERIORITY|||||||0.34|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at baseline.||||0.34
74065809|NCT02273206|147684187|SUPERIORITY|||||||0.31|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 6 months. .||||0.31
74065810|NCT02273206|147684187|SUPERIORITY|||||||0.39|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 12 months.||||0.39
74065811|NCT02273206|147684187|SUPERIORITY|||||||0.87|||||||Chi-squared|||Physician Recommendation of Mental Health Care at baseline.||||0.87
74065812|NCT02273206|147684187|SUPERIORITY|||||||0.83|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 6 months.||||0.83
74065813|NCT02273206|147684187|SUPERIORITY|||||||0.36|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 12 months.||||0.36
74065814|NCT02273206|147684188|SUPERIORITY|||||||0.95|||||||Chi-squared|||Generalized Anxiety Disorder scale at baseline. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.95
74065815|NCT02273206|147684188|SUPERIORITY|||||||0.08|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 6 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.08
74065816|NCT02273206|147684188|SUPERIORITY|||||||0.27|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 12 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.27
74065817|NCT02273206|147684189|SUPERIORITY|||||||0.54|||||||Chi-squared|||Medical Outcomes Study Health Survey at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.54
74065818|NCT02273206|147684189|SUPERIORITY|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.68
74065819|NCT02273206|147684189|SUPERIORITY|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.68
74065820|NCT02273206|147684190|SUPERIORITY|||||||0.74|||||||Chi-squared|||Colorectal Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.74
74065821|NCT02273206|147684190|SUPERIORITY|||||||0.86|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.86
74065822|NCT02273206|147684190|SUPERIORITY|||||||0.79|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.79
74065823|NCT02273206|147684190|SUPERIORITY|||||||0.91|||||||Chi-squared|||Breast Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.91
74065824|NCT02273206|147684190|SUPERIORITY|||||||0.71|||||||Chi-squared|||Breast Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.71
74065825|NCT02273206|147684190|SUPERIORITY|||||||0.77|||||||Chi-squared|||Breast Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.77
74065826|NCT02273206|147684190|SUPERIORITY|||||||0.64|||||||Chi-squared|||Cervical Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.64
74065827|NCT02273206|147684190|SUPERIORITY|||||||0.11|||||||Chi-squared|||Cervical Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.11
73883166|NCT01751061|147300351|SUPERIORITY|To test the primary hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.|||||<|0.05||||||P values were calculated. A two-sided type-I error rate of 0.05 was set for all tests; there were no adjustments for multiple comparisons. All participants were included in analyses as per their group randomization.|GEE|||We estimated that 210 patients (315 surrogates, assuming \~1.5 per patient) would provide a power of 80% to detect a between-groups mean CSCS score difference of 9 percentage points between Interviews 1 and 2, assuming a baseline mean of 50, SD=24, a type-I error=5%, a correlation between interviews of 0.5, an expectation that 50% of patients would have multiple surrogates, an intraclass correlation coefficient of 0.8 for multiple surrogates for a patient, and 5% dropout before Interview 2.||||<0.05
73883167|NCT01751061|147300352|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear model|||Generalized linear model.||||<0.05
74065828|NCT02273206|147684190|SUPERIORITY|||||||1|||||||Chi-squared|||Cervical Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||1.00
74065829|NCT02273206|147684192|SUPERIORITY|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months. Recoding of the continuous measure was based on quartiles.||||0.56
74065830|NCT02273206|147684193|SUPERIORITY|||||||0.18|||||||Chi-squared|||Devaluation-Discrimination Scale Score at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.18
74065831|NCT02273206|147684193|SUPERIORITY|||||||0.32|||||||Chi-squared|||Devaluation-Discrimination Scale score at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.32
74065832|NCT02273206|147684194|SUPERIORITY|||||||0.5|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.50
74065833|NCT02273206|147684194|SUPERIORITY|||||||0.51|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.51
74065834|NCT02273206|147684194|SUPERIORITY|||||||0.02|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.02
74065835|NCT02273206|147684194|SUPERIORITY|||||||0.91|||||||Chi-squared|||Ambulatory Care Experiences - Access at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.91
74065836|NCT02273206|147684194|SUPERIORITY|||||||0.69|||||||Chi-squared|||Ambulatory Care Experiences - Access at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.69
74065837|NCT02273206|147684194|SUPERIORITY|||||||0.63|||||||Chi-squared|||Ambulatory Care Experiences - Access at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.63
74065838|NCT02273206|147684194|SUPERIORITY|||||||0.55|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.55
74065839|NCT02273206|147684194|SUPERIORITY|||||||0.34|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.34
74065840|NCT02273206|147684194|SUPERIORITY|||||||0.19|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.19
74065841|NCT02273206|147684194|SUPERIORITY|||||||0.47|||||||Chi-squared|||Ambulatory Care Experiences - Quality at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.47
74065842|NCT02273206|147684194|SUPERIORITY|||||||0.38|||||||Chi-squared|||Ambulatory Care Experiences - Quality at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.38
74065843|NCT02273206|147684194|SUPERIORITY|||||||0.98|||||||Chi-squared|||Ambulatory Care Experiences - Quality at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.98
74065844|NCT02273206|147684195|SUPERIORITY|||||||0.78|||||||Chi-squared|||Medication Adherence at baseline. Coding of the measure was based on Morisky et al. (2008).||||0.78
74065845|NCT02273206|147684195|SUPERIORITY|||||||0.2|||||||Chi-squared|||Medication Adherence at 6 months. Coding of the measure was based on Morisky et al. (2008).||||0.20
74065846|NCT02273206|147684195|SUPERIORITY|||||||0.77|||||||Chi-squared|||Medication Adherence at 12 Months. Coding of the measure was based on Morisky et al. (2008).||||0.77
74065847|NCT02273206|147684196|SUPERIORITY|||||||0.7|||||||Chi-squared|||Self-efficacy at baseline.Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.70
74065848|NCT02273206|147684196|SUPERIORITY|||||||0.89|||||||Chi-squared|||Self-efficacy at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.89
73883168|NCT01751061|147300353|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear model|||||||<0.05
73883169|NCT01751061|147300354|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
74065849|NCT02273206|147684196|SUPERIORITY|||||||0.95|||||||Chi-squared|||Self-efficacy at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.95
74065850|NCT03063632|147684200|OTHER|||||||||||||||||Per Global Response Score used in Mycosis Fungoides and Sezary Syndrome, Response is assessed by the standard response criteria: Complete Response (CR), complete disappearance of all clinical evidence of disease where all categories (i.e., skin, lymph nodes, viscera, blood) have complete response/noninvolved; Partial Response (PR), regression of measurable disease; Stable Disease (SD), failure to attain CR, PR, or PD.|Simple statistics. Non-responders excluded from analysis.|||
74065851|NCT03063632|147684201|OTHER||||||||||||||||||Kaplan-Meier method|||
74065852|NCT03063632|147684202|OTHER|||||||||||||||||Progression is assessed by the standard response criteria used in Mycosis Fungoides and Sezary Syndrome (skin, lymph nodes, viscera, blood, global). Per Global Response Score, progression is defined as Progressive Disease (PD) in any category (i.e., skin, lymph nodes, viscera, blood).|Kaplan-Meier method|||
74065853|NCT03063632|147684203|OTHER||||||||||||||||||Kaplan-Meier method|||
74065854|NCT03063632|147684204|OTHER||||||||||||||||||Binomial distribution|||
74065855|NCT00373685|147684208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED|||||Life Table Extension of Cochran-Mantel-Haenszel (CMH) Test|Life Table Extension of CMH Test|||||||0.0003
74065856|NCT00373685|147684209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035|TWO_SIDED||||||Life Table Extension of CMH Test|||||||0.0035
74065857|NCT00373685|147684210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614|TWO_SIDED||||||Life Table Extension of CMH Test|||||||0.6140
73883170|NCT01751061|147300355|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
73883171|NCT01751061|147300356|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
74065858|NCT00373685|147684212|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||P-value associated with Overall (LOCF)|ANCOVA|||||||<0.0001
74065859|NCT00373685|147684214|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||P-value associated with Overall (LOCF)|ANCOVA|||||||<0.0001
74065860|NCT00373685|147684215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0023|TWO_SIDED|||||P-value associated with Overall (LOCF)|Cochran-Mantel-Haenszel|||||||0.0023
74065861|NCT00373685|147684216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1008|TWO_SIDED||||||Chi-squared|||Baseline||||0.1008
74065862|NCT00373685|147684216|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
74065863|NCT00373685|147684216|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
73883172|NCT01751061|147300357|SUPERIORITY||||||<|0.05||||||P values were calculated.|GEE|||To test the hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.||||<0.05
74065864|NCT00373685|147684216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0005
74065865|NCT00373685|147684216|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||<0.0001
74065866|NCT00373685|147684217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6562|TWO_SIDED||||||Chi-squared|||Baseline||||0.6562
74065867|NCT00373685|147684217|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
74065868|NCT00373685|147684217|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
74065869|NCT00373685|147684217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0245|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0245
74065870|NCT00373685|147684217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0074|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0074
74065871|NCT00373685|147684218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4074|TWO_SIDED||||||Chi-squared|||Baseline||||0.4074
74065872|NCT00373685|147684218|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
74065873|NCT00373685|147684218|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
74065874|NCT00373685|147684218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0127
74065875|NCT00373685|147684218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0019
74065876|NCT00373685|147684219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2699|TWO_SIDED||||||Chi-squared|||Baseline||||0.2699
74065877|NCT00373685|147684219|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
74065878|NCT00373685|147684219|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
74065879|NCT00373685|147684219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0027|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0027
74065880|NCT00373685|147684219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0001
74065881|NCT02570165|147684223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|191.1|||||TWO_SIDED|95.0|101.07|284.26|||||The 95% Bayesian credible interval for the mean difference between batefenterol 37.5 µg dose and placebo (batefenterol 37.5 µg minus placebo) was estimated.|||284.26|101.07|
74065882|NCT02570165|147684223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|231.6|||||TWO_SIDED|95.0|149.31|310.02|||||The 95% Bayesian credible interval for differences between each individual batefenterol 75 µg dose and placebo was estimated.|||310.02|149.31|
74065883|NCT02570165|147684223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|261.8|||||TWO_SIDED|95.0|189.85|332.25|||||The 95% Bayesian credible interval for differences between each individual batefenterol 150 µg dose and placebo was estimated.|||332.25|189.85|
74065884|NCT02570165|147684223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|281.4|||||TWO_SIDED|95.0|212.35|351.3|||||The 95% Bayesian credible interval for differences between each individual batefenterol 300 µg dose and placebo was estimated.|||351.30|212.35|
74065885|NCT02570165|147684223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|292.8|||||TWO_SIDED|95.0|223.02|364.42|||||The 95% Bayesian credible interval for differences between each individual batefenterol 600 µg dose and placebo was estimated.|||364.42|223.02|
74065886|NCT02570165|147684224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|182.2|||||TWO_SIDED|95.0|99.8|264.6|||||The 95% confidence interval for the difference between 37.5 µg Batefenterol and Placebo was estimated.|||264.60|99.80|
74065887|NCT02570165|147684224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|196.6|||||TWO_SIDED|95.0|128.4|264.8|||||The 95% confidence interval for the difference between 75 µg Batefenterol and Placebo was estimated.|||264.80|128.40|
74065888|NCT02570165|147684224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|204.6|||||TWO_SIDED|95.0|137.2|272.1|||||The 95% confidence interval for the difference between 150 µg Batefenterol and Placebo was estimated.|||272.10|137.20|
74065889|NCT02570165|147684224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|208.9|||||TWO_SIDED|95.0|138.7|279.2|||||The 95% confidence interval for the difference between 300 µg Batefenterol and Placebo was estimated.|||279.20|138.70|
74065890|NCT02570165|147684224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.1|||||TWO_SIDED|95.0|138.6|283.7|||||The 95% confidence interval for the difference between 600 µg Batefenterol and Placebo was estimated.|||283.70|138.60|
74065891|NCT00479401|147684238|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority hypothesis comparing pramipexole ER to pramipexole IR was to be tested using a non-inferiority margin of -3 points. The primary efficacy endpoint in UPDRS part II+III was the change from baseline (week 0) to week 33 on the UPDRS Parts II+III score combined. The statistical model was analysis of covariance, controlling for baseline UPDRS Part II+III. Fixed terms in the model were treatment, country, and UPDRS Part II+III score at baseline.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.2|1.7|||ANCOVA|Null hypothesis was tested using an analysis of covariance model with α = 0.05 in full analysis set with last observation carried forward.|PPX ER non-inferior to PPX IR, if the lower limit of the confidence interval for the difference is higher than the non-inferiority margin of -3|A non-inferiority hypothesis (H0: μER - μIR \< -3 vs. H1: μER - μIR ≥ -3) comparing pramipexole ER to pramipexole IR was tested using a non-inferiority margin of -3 points.||1.7|-2.2|
74065892|NCT00362401|147684289|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The comparison of the three valve groups with respect to the objective sound measures was made by the one-way ANOVA method. The null hypothesis is that there is no difference on intensity of heart valve sounds among the three groups.||||<0.05
74065893|NCT02544633|147684290|SUPERIORITY|An exact test for single proportion (two-sided a=5%) will be performed to test H0: ORR \<=20% against H1: ORR \>20%.|Objective response rate|10.7||||0.94|TWO_SIDED|95.0|2.27|28.23|||exact test|||||28.23|2.27|0.94
74065894|NCT02544633|147684290|SUPERIORITY||Objective response rate|15.0||||0.79|TWO_SIDED|95.0|3.21|37.89|||exact test|||||37.89|3.21|0.79
74065895|NCT02544633|147684290|SUPERIORITY||Objective response rate|25.0||||0.47|TWO_SIDED|95.0|3.19|65.09|||Exact Test|||||65.09|3.19|0.47
74065896|NCT02544633|147684290|SUPERIORITY||Objective response rate|0.0|||>|0.999|TWO_SIDED|95.0|0.0|26.46|||Exact test|||||26.46|0.00|>0.999
74065897|NCT02270983|147684314|SUPERIORITY||Least squares mean difference|1.325|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|0.439|2.211|||ANCOVA|||||2.211|0.439|0.0035
74065898|NCT02270983|147684314|SUPERIORITY||Least squares mean difference|1.908|STANDARD_ERROR_OF_MEAN|0.451|<|0.0001|TWO_SIDED|95.0|1.021|2.796|||ANCOVA|||||2.796|1.021|<0.0001
74065899|NCT02270983|147684315|SUPERIORITY||Cox Proportional Hazard|1.28||||0.1429|TWO_SIDED|95.0|0.92|1.77|||Log Rank|||||1.77|0.92|0.1429
74065900|NCT02270983|147684315|SUPERIORITY||Cox Proportional Hazard|1.43||||0.0287|TWO_SIDED|95.0|1.04|1.97|||Log Rank|||||1.97|1.04|0.0287
74065901|NCT02270983|147684316|SUPERIORITY||Odds Ratio (OR)|1.37||||0.3332|TWO_SIDED|95.0|0.73|2.58|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.||||2.58|0.73|0.3332
74065902|NCT02270983|147684316|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0506|TWO_SIDED|95.0|1.0|3.68|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.||||3.68|1.00|0.0506
73883173|NCT00904943|147300369|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|104.27|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Mean falls within 80-125.|||||
74065903|NCT02270983|147684317|SUPERIORITY||Least squares mean difference|0.751|STANDARD_ERROR_OF_MEAN|0.217||0.0007|TWO_SIDED|95.0|0.324|1.178|||ANCOVA|||||1.178|0.324|0.0007
74065904|NCT02270983|147684317|SUPERIORITY||Least squares mean difference|0.987|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|0.558|1.416|||ANCOVA|||||1.416|0.558|<0.0001
74065905|NCT02270983|147684318|SUPERIORITY||Least squares mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.145||0.0017|TWO_SIDED|95.0|-0.746|-0.174|||ANCOVA|||||-0.174|-0.746|0.0017
74065906|NCT02270983|147684318|SUPERIORITY||Least squares mean difference|-0.669|STANDARD_ERROR_OF_MEAN|0.146|<|0.0001|TWO_SIDED|95.0|-0.957|-0.382|||ANCOVA|||||-0.382|-0.957|<0.0001
74065907|NCT02270983|147684319|SUPERIORITY||Least squares mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.205||0.872|TWO_SIDED|95.0|-0.371|0.437|||ANCOVA|||||0.437|-0.371|0.8720
74065908|NCT02270983|147684319|SUPERIORITY||Least squares mean difference|-0.607|STANDARD_ERROR_OF_MEAN|0.205||0.0034|TWO_SIDED|95.0|-1.011|-0.203|||ANCOVA|||||-0.203|-1.011|0.0034
74065909|NCT00740727|147684351|SUPERIORITY_OR_OTHER||% of subjects with infusion pain|11.1||||||95.0|1.4|34.7|||95% binomial exact confidence interval|||This analysis reports the number of subjects (of 18 possible) who experienced pain, during EASI placement or infusion, at the a priori-defined level of at least 3 on a 10-point pain scale.||34.7|1.4|
74065910|NCT00740727|147684352|SUPERIORITY_OR_OTHER||% subjects with next-day EASI site pain|0.0||||||97.5|0.0|18.5|||binomial exact confidence interval|Because the point estimate was zero, the statistical software (STATA version 10MP) reports a one-sided 97.5% confidence interval.||This analysis reports the number of subjects (of 18 possible) who experienced pain, as assessed on next-day follow-up (24 hours after EASI infusion), at the a priori-defined level of at least 3 on a 10-point pain scale.||18.5|0|
74065911|NCT04364165|147684353|SUPERIORITY||Odds Ratio (OR)|2.0||||0.01|TWO_SIDED|95.0|1.44|2.78|||Regression, Logistic|||||2.78|1.44|.01
74065912|NCT04364165|147684354|SUPERIORITY||Odds Ratio (OR)|1.44||||0.41|TWO_SIDED|95.0|0.36|5.78|||Regression, Logistic|||||5.78|0.36|.41
74065913|NCT01706198|147684470|OTHER||Adjusted Odds Ratio|2.0|||<|0.001|TWO_SIDED|95.0|1.7|2.34||The analysis method was logistic regression adjusted for randomized treatment, asthma maintenance therapy (AMT) at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care has been presented.|||2.34|1.70|<0.001
74065914|NCT01706198|147684471|OTHER||Adjusted Odds Ratio|1.92|||<|0.001|TWO_SIDED|95.0|1.67|2.2||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 12 has been presented.|||2.20|1.67|<0.001
74065915|NCT01706198|147684471|OTHER||Adjusted Odds Ratio|1.66|||<|0.001|TWO_SIDED|95.0|1.45|1.91||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 40 has been presented.|||1.91|1.45|<0.001
74065916|NCT01706198|147684471|OTHER||Adjusted Odds Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.54|2.02||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 52 has been presented.|||2.02|1.54|<0.001
74065917|NCT01706198|147684472|OTHER||Adjusted Odds Ratio|2.09|||<|0.001|TWO_SIDED|95.0|1.82|2.4||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.|||2.40|1.82|<0.001
74065918|NCT01706198|147684472|OTHER||Adjusted Odds Ratio|1.96|||<|0.001|TWO_SIDED|95.0|1.7|2.25||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.|||2.25|1.70|<0.001
74065919|NCT01706198|147684472|OTHER||Adjusted Odds Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.56|2.06||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.|||2.06|1.56|<0.001
74065920|NCT01706198|147684472|OTHER||Adjusted Odds Ratio|1.95|||<|0.001|TWO_SIDED|95.0|1.69|2.24||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.|||2.24|1.69|<0.001
74065921|NCT01706198|147684473|OTHER||Adjusted Odds Ratio|2.28|||<|0.001|TWO_SIDED|95.0|1.98|2.62||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.|||2.62|1.98|<0.001
74065922|NCT01706198|147684473|OTHER||Adjusted Odds Ratio|2.09|||<|0.001|TWO_SIDED|95.0|1.81|2.41||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.|||2.41|1.81|<0.001
74065923|NCT01706198|147684473|OTHER||Adjusted Odds Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.53|2.02||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.|||2.02|1.53|<0.001
74065924|NCT01706198|147684473|OTHER||Adjusted Odds Ratio|1.91|||<|0.001|TWO_SIDED|95.0|1.66|2.21||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.|||2.21|1.66|<0.001
74065925|NCT01706198|147684474|OTHER||Mean Difference (Net)|1.54|||<|0.001|TWO_SIDED|95.0|1.3|1.77||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|Mixed Model Repeated Measures (MMRM)||Treatment difference of FF/VI versus Usual Care at Week 12 has been presented.|||1.77|1.30|<0.001
74065926|NCT01706198|147684474|OTHER||Mean Difference (Net)|1.5|||<|0.001|TWO_SIDED|95.0|1.25|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 24 has been presented.|||1.76|1.25|<0.001
74065927|NCT01706198|147684474|OTHER||Mean Difference (Net)|1.37|||<|0.001|TWO_SIDED|95.0|1.11|1.63||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 40 has been presented.|||1.63|1.11|<0.001
74065928|NCT01706198|147684474|OTHER||Mean Difference (Net)|1.5|||<|0.001|TWO_SIDED|95.0|1.24|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 52 has been presented.|||1.76|1.24|<0.001
74065929|NCT01706198|147684476|OTHER||Ratio|1.03||||0.786|TWO_SIDED|95.0|0.83|1.28||GLM assuming negative binomial distribution (NBD) adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.28|0.83|0.786
74065930|NCT01706198|147684477|OTHER||Ratio|1.02||||0.461|TWO_SIDED|95.0|0.97|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.08|0.97|0.461
74065931|NCT01706198|147684479|OTHER||Ratio|0.99||||0.822|TWO_SIDED|95.0|0.91|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.08|0.91|0.822
74065932|NCT01706198|147684480|OTHER||Ratio|1.1|||<|0.001|TWO_SIDED|95.0|1.05|1.15||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.15|1.05|<0.001
74065933|NCT01706198|147684482|OTHER||Ratio|0.98||||0.697|TWO_SIDED|95.0|0.88|1.09||GLM assuming NBD adjusted for randomized treatment; asthma maintenance therapy and ACT total score at Baseline per randomization stratification; number of severe asthma exacerbations in previous year prior to randomization categorized; gender \& age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.09|0.88|0.697
74065934|NCT01706198|147684483|OTHER||Hazard Ratio (HR)|0.96||||0.504|TWO_SIDED|95.0|0.86|1.07||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||A hazard ratio \<1 indicated a lower risk with FF/VI compared with Usual Care|||1.07|0.86|0.504
74065935|NCT01706198|147684484|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender,age \& number of salbutamol inhalers in year prior to randomization|ANCOVA||Difference of FF/VI versus Usual Care has been presented.|||-0.5|-1.1|<0.001
74065936|NCT01706198|147684485|OTHER||Hazard Ratio (HR)|1.23|||<|0.001|TWO_SIDED|95.0|1.09|1.38||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented|||1.38|1.09|<0.001
74065937|NCT01706198|147684486|OTHER||Adjusted Odds Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.55|2.06||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI with Usual Care has been presented.|||2.06|1.55|<0.001
74065938|NCT01706198|147684487|OTHER||Adjusted Odds Ratio|1.51|||<|0.001|TWO_SIDED|95.0|1.31|1.73||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI versus Usual Care has been presented.|||1.73|1.31|<0.001
74065939|NCT01706198|147684488|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.4|||||TWO_SIDED|95.0|0.8|2.7|||||Incidence ratio was calculated as percentage of participants who had at least one SAE of pneumonia in the FF/VI group divided by the percentage of participants who had at least one SAE of pneumonia in the Usual Care group.|||2.7|0.8|
73883174|NCT00904943|147300370|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|102.35|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.|||||
74065940|NCT01706198|147684489|OTHER||Hazard Ratio (HR)|1.45||||0.255|TWO_SIDED|95.0|0.77|2.74||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates.|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented.|||2.74|0.77|0.255
74065941|NCT01473758|147684503|SUPERIORITY_OR_OTHER||LS Mean Difference|1.404|STANDARD_ERROR_OF_MEAN|3.07||0.6491|TWO_SIDED|95.0|-4.731|7.538||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA|||||7.538|-4.731|0.6491
74065942|NCT01473758|147684504|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.412|STANDARD_ERROR_OF_MEAN|2.687||0.8786|TWO_SIDED|95.0|-5.766|4.943||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA|||||4.943|-5.766|0.8786
74065943|NCT02763579|147684561|SUPERIORITY||Stratified Hazard Ratio|0.77||||0.017|TWO_SIDED|95.0|0.62|0.96|||Log Rank|||||0.96|0.62|0.0170
74065944|NCT02763579|147684562|SUPERIORITY||Stratified Hazard Ratio|0.7||||0.0069|TWO_SIDED|95.0|0.54|0.91|||Log Rank|||||0.91|0.54|0.0069
74065945|NCT02763579|147684563|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.37||||||||1.37|0.55|
74065946|NCT02763579|147684564|SUPERIORITY||Hazard Ratio (HR)|0.715||||0.0063|TWO_SIDED|95.0|0.562|0.911|||Log Rank|||||0.911|0.562|0.0063
74065947|NCT02763579|147684565|SUPERIORITY||Difference in Event Free Rate|8.47||||0.0593|TWO_SIDED|95.0|-0.33|17.27|||Z-test|||PFS Rate at 6 months||17.27|-0.33|0.0593
74065948|NCT02763579|147684565|SUPERIORITY||Difference in Event Free Rate|7.27||||0.0133|TWO_SIDED|95.0|1.52|13.02|||Z-test|||PFS Rate at 1 year||13.02|1.52|0.0133
74065949|NCT02763579|147684566|SUPERIORITY||Difference in Event Free Rate|13.46||||0.0095|TWO_SIDED|95.0|3.29|23.64|||Z-test|||OS Rate at 1 year||23.64|3.29|0.0095
74065950|NCT02763579|147684567|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.221||||0.3604|TWO_SIDED|95.0|0.795|1.874|||Log Rank|||Cough||1.874|0.795|0.3604
74065951|NCT02763579|147684567|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.058||||0.7712|TWO_SIDED|95.0|0.722|1.553|||Log Rank|||Pain in Chest||1.553|0.722|0.7712
74065952|NCT02763579|147684567|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.077||||0.6922|TWO_SIDED|95.0|0.747|1.552|||Log Rank|||Pain in Arm or Shoulder||1.552|0.747|0.6922
74065953|NCT02763579|147684567|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|0.748||||0.065|TWO_SIDED|95.0|0.549|1.019|||Log Rank|||Dyspnea||1.019|0.549|0.0650
74065954|NCT02965820|147684574|SUPERIORITY||||||=|0.003|||||||Mixed Models Analysis|||||||=0.0030
74065955|NCT01967888|147684575|SUPERIORITY||t-test|-1.2||||0.542|TWO_SIDED|95.0|-14.3|0.0|||Cochran-Mantel-Haenszel|||||000|-14.3|0.542
74065956|NCT01967888|147684576|SUPERIORITY||least square mean difference|-0.1601778||||0.092|TWO_SIDED|95.0|-0.317803|-0.0025525|||t-test, 2 sided|||||-0.0025525|-0.3178030|0.092
74065957|NCT01967888|147684577|SUPERIORITY||least square mean difference|-0.1178242||||0.161|TWO_SIDED|95.0|-0.287431|0.0517825|||t-test, 2 sided|||||0.0517825|-0.2874310|0.161
74065958|NCT01967888|147684578|SUPERIORITY||least square mean difference|0.0136||||0.846|TWO_SIDED|95.0|-0.0508|0.0781|||t-test, 2 sided|||||0.0781|-0.0508|0.846
74065959|NCT01967888|147684579|SUPERIORITY||least square mean difference|-0.025||||0.817|TWO_SIDED|95.0|-0.0939|0.0689|||t-test, 2 sided|||||0.0689|-0.0939|0.817
74065960|NCT01967888|147684580|SUPERIORITY||least square mean difference|-9.4641||||0.57|TWO_SIDED|95.0|-42.49|23.5618|||Mixed Models Analysis|||||23.5618|-42.4900|0.570
74065961|NCT01967888|147684581|SUPERIORITY||least square mean difference|-22.9454|||=|0.074|TWO_SIDED|95.0|-48.1826|2.2918|||Mixed Models Analysis|||||2.2918|-48.1826|=0.074
74065962|NCT01967888|147684582|SUPERIORITY||least square mean difference|-0.2074|||=|0.358|TWO_SIDED|95.0|-0.6538|0.2389|||Mixed Models Analysis|||||0.2389|-0.6538|=0.358
74065963|NCT01967888|147684583|SUPERIORITY||least square mean difference|-0.277|||=|0.288|TWO_SIDED|95.0|-0.7936|0.2396|||Mixed Models Analysis|||||0.2396|-0.7936|=0.288
74065964|NCT01967888|147684584|SUPERIORITY||least square mean difference|0.09716|||=|0.98|TWO_SIDED|95.0|-7.41834|7.61266|||Mixed Models Analysis|||||7.61266|-7.41834|=0.980
74065965|NCT01967888|147684585|SUPERIORITY||least square mean difference|1.07617|||=|0.785|TWO_SIDED|95.0|-6.76562|8.91796|||Mixed Models Analysis|||||8.91796|-6.76562|=0.785
73883175|NCT00904943|147300371|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|103.66|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.|||||
74065966|NCT01967888|147684586|SUPERIORITY|||||||0.176|||||||Wilcoxon (Mann-Whitney)|||||||0.176
74065967|NCT01967888|147684587|SUPERIORITY|||||||0.403|||||||Wilcoxon (Mann-Whitney)|||||||0.403
74065968|NCT01967888|147684588|SUPERIORITY||Treatment effect|2.1||||0.842|TWO_SIDED|95.0|-18.2|22.33|||Chi-squared|||||22.33|-18.20|0.842
74065969|NCT01967888|147684589|SUPERIORITY||Hazard Ratio (HR)|3.21||||0.339|TWO_SIDED|95.0|0.29|34.97|||Anderson-Gill model|||||34.97|0.29|0.339
74065970|NCT01967888|147684590|SUPERIORITY||Treatment effect|5.0||||0.64|TWO_SIDED|95.0|-15.91|25.93|||Chi-squared|||||25.93|-15.91|0.640
74065971|NCT01967888|147684596|SUPERIORITY|||||||0.448|||||||Wilcoxon rank-sum test|||||||0.448
74065972|NCT01967888|147684597|SUPERIORITY|||||||0.91|||||||Wilcoxon rank-sum test|||||||0.910
74065973|NCT01967888|147684598|SUPERIORITY|||||||1|||||||Wilcoxon rank-sum test|||||||1.000
74065974|NCT01967888|147684603|SUPERIORITY||least square mean difference|31.3491|||=|0.5018|TWO_SIDED|95.0|-60.998|123.7|||Mixed Models Analysis|||||123.70|-60.9980|=0.5018
74065975|NCT01967888|147684604|SUPERIORITY||Least square mean difference|23.5454|||=|0.4537|TWO_SIDED|95.0|-38.6619|85.7528|||Mixed Models Analysis|||||85.7528|-38.6619|=0.4537
74065976|NCT01859325|147684649|SUPERIORITY||Median Difference (Final Values)|-0.36||||0.406|TWO_SIDED|95.0|-1.41|0.67|||Wilcoxon (Mann-Whitney)|||Samples size based on published data on populations of early treated patients undergoing ART interruption. The power based on a 2-sample t-test with a 2-tailed alpha of .05 and a total sample size of 30 is approximately 91% to detect a 1.25 log10 reduction in the rebound plasma viremia between vaccine and placebo groups.||0.67|-1.41|0.406
74065977|NCT00033631|147684656|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.83|1.2||Two-sided test, significance level = 0.05|Log Rank||Reference level = 70.2 Gy arm|The original target sample size was 1520 patients with a requirement of 715 deaths to test the hypothesis of overall survival (OS) efficacy of the 79.2 Gy arm. The trial was designed to detect a hazard ratio (HR) of 1.30 (standard/high-dose) with 90% statistical power at a one-sided significance level of 0.025.||1.2|0.83|0.98
74065978|NCT00033631|147684657|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.5|0.7||Two-sided significance level = 0.05|Gray's test|Reference arm is 70.2 Gy arm||||0.70|0.50|<0.0001
74065979|NCT00033631|147684658|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.14|TWO_SIDED|95.0|0.38|1.15|||Gray's test|Two-sided significance level = 0.05|Reference level is 70.2 Gy arm|||1.15|0.38|0.14
74065980|NCT00033631|147684659|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.41||||0.0001|TWO_SIDED|95.0|0.25|0.66|||Gray's test|Two-sided significance level = 0.05|Reference level = 70.2 Gy arm|||0.66|0.25|0.0001
74065981|NCT00033631|147684660|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65||||0.051|TWO_SIDED|95.0|0.42|1.01||Two-sided significance level = 0.05|Gray's test||Reference level is the 70.2 Gy level|||1.01|0.42|0.051
74065982|NCT00033631|147684661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||Two-sided significance level = 0.05|Chi-squared|||||||0.29
74065983|NCT00033631|147684662|SUPERIORITY|||||||0.0513|||||||Chi-squared|Two-sided significance level = 0.05||With an expected percentage of erectile disfunction (ED) at 12 months of 29%, a two-sided significance level of 0.05, and 688 patients per arm provides 90% statistical power to detect a reduction in ED to 19%. This calculation assumes 26% ED at baseline and 80% compliance at 12 months. Only participants with baseline ED are analyzed.||||0.0513
74065984|NCT00033631|147684663|SUPERIORITY|||||||0.59|||||||Chi-squared|Two-sided significance level = 0.05||||||0.59
74065985|NCT01827371|147684668|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|1.32|||||TWO_SIDED|98.33|0.72|1.93||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) \< 1 or GMT(Arm A)/GMT(Arm B) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.93|0.72|
74065986|NCT01827371|147684668|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.86|||||TWO_SIDED|98.33|0.26|1.47||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) \< 1 or GMT(Arm A)/GMT(Arm C) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.47|0.26|
74065987|NCT01827371|147684668|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.41|||||TWO_SIDED|98.33|-0.17|1.0007||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) \< 1 or GMT(Arm A)/GMT(Arm D) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.0007|-0.17|
74065988|NCT01827371|147684669|SUPERIORITY_OR_OTHER|||||||0.4782|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Pain at Injection Site ' Arm A) = Pr('Pain at Injection Site ' Arm D) H1: Pr('Pain at Injection Site ' Arm A) not = Pr('Pain at Injection Site ' Arm D)"||||0.4782
74065989|NCT01827371|147684669|SUPERIORITY_OR_OTHER|||||||0.1704|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Itchiness at Injection Site' Arm A) = Pr('Itchiness at Injection Site' Arm D) H1: Pr('Itchiness at Injection Site' Arm A) not = Pr('Itchiness at Injection Site' Arm D)"||||0.1704
74065990|NCT01827371|147684669|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm pain' Arm A) = Pr('Underarm pain' Arm D) H1: Pr('Underarm pain' Arm A) not = Pr('Underarm pain' Arm D)"||||1.000
74065991|NCT01827371|147684669|SUPERIORITY_OR_OTHER|||||||0.6171|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm swelling' Arm A) = Pr('Underarm swelling' Arm D) H1: Pr('Underarm swelling' Arm A) not = Pr('Underarm swelling' Arm D)"||||0.6171
74065992|NCT01827371|147684669|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Redness at Injection Site' Arm A) = Pr('Redness at Injection Site' Arm D) H1: Pr('Redness at Injection Site' Arm A) not = Pr('Redness at Injection Site' Arm D)"||||<0.0001
74065993|NCT01827371|147684669|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Swelling at Injection Site' Arm A) = Pr('Swelling at Injection Site' Arm D) H1: Pr('Swelling at Injection Site' Arm A) not = Pr('Swelling at Injection Site' Arm D)"||||0.0050
74065994|NCT01827371|147684669|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Any Solicited Local Reaction' Arm A) = Pr('Any Solicited Local Reaction' Arm D) H1: Pr('Any Solicited Local Reaction' Arm A) not = Pr('Any Solicited Local Reaction' Arm D)"||||0.0012
74065995|NCT01827371|147684670|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.76|||||TWO_SIDED|98.33|0.37|1.15||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) \< 1 or GMT(Arm A)/GMT(Arm B) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||1.15|0.37|
74065996|NCT01827371|147684670|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.3|||||TWO_SIDED|98.33|-0.06|0.67||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) \< 1 or GMT(Arm A)/GMT(Arm C) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||0.67|-0.06|
74065997|NCT01827371|147684670|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|-0.1|||||TWO_SIDED|98.33|-0.5|0.3||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) \< 1 or GMT(Arm A)/GMT(Arm D) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||0.30|-0.50|
74065998|NCT03803085|147684672|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
74065999|NCT03803085|147684673|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
74066000|NCT03803085|147684674|SUPERIORITY|||||||0.06||||||p\<0.05 was considered significant.|Mixed Models Analysis|||||||0.06
74066001|NCT00769015|147684698|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.54||||0.067|TWO_SIDED|95.0|0.27|1.06||Mantel-Haenszel chi-square test. The p-value refers to the overall test of between group differences in rates of depression.|Mantel Haenszel|||||1.06|.27|.067
74066002|NCT00769015|147684699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.75|TWO_SIDED|95.0|-5.92|4.3|||Linear Mixed effects model|||||4.30|-5.92|.75
74066003|NCT00769015|147684700|SUPERIORITY_OR_OTHER||Change in least squares mean|3.47||||0.68|TWO_SIDED|95.0|-12.22|5.29|||Mixed Models Analysis|||||5.29|-12.22|.68
73883176|NCT01194830|147300372|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.16||0.0005||95.0|-0.91|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.91|0.0005
74066004|NCT00769015|147684701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.42||||0.34|TWO_SIDED|95.0|-2.58|7.41|||Least squares mean|||||7.41|-2.58|.34
74066005|NCT00769015|147684702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.68|TWO_SIDED|95.0|-9.8|5.76|||Least squares mean|||||5.76|-9.80|.68
74066006|NCT00769015|147684703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.68|TWO_SIDED|95.0|-4.04|6.82|||Least squares mean|||||6.82|-4.04|.68
73883177|NCT01194830|147300373|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.62|-0.22|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.22|-0.62|<0.0001
74066007|NCT00769015|147684704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62||||0.68|TWO_SIDED|95.0|-5.94|9.17|||Least squares mean|||||9.17|-5.94|.68
74066008|NCT03182686|147684725|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"H0:π ≤ π0 versus HA:π \> π0~Where π0 is the hypothesized clinically significant value for the proportion of responders. The value will be 30% in this study. This test will be tested using an exact binomial test. That is, given the sample size of n, the number of responders X, and the value of π0 =0.30, then probability that X or more events would be observed will be calculated as the p-value. Since this is a one-sided test, the alpha level will be 0.025."||||<0.0001
74066009|NCT00529568|147684753|SUPERIORITY_OR_OTHER||Percentage difference in SVR|6.0||||0.0202|TWO_SIDED|95.0|1.2|10.9||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.|||10.9|1.2|0.0202
74066010|NCT00185211|147684823|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to CDMS is ≥ t) are identical for both treatment arms for all points in time t\>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to CDMS is ≥ t) are not identical for both treatment arms for some points in time t\>0."||||0.0027
74066011|NCT00185211|147684823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.663||||0.0028||97.47|0.488|0.902|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to CDMS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for CDMS, i.e. hazard ratio = 1.||0.902|0.488|0.0028
74066012|NCT00185211|147684824|SUPERIORITY_OR_OTHER|||||||0.1768||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was: H0: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are not identical for both treatment arms for some points in time t\>0. The two-sided alternative hypothesis was: H1: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are identical for both treatment arms for some points in time t\>0.||||0.1768
74066013|NCT00185211|147684824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.1604||97.47|0.497|1.174|||Regression, Cox|The variable used as additional covariate adjustment was volume of T2 lesions on screening MRI.|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to confirmed EDSS progression was modelled by a Cox proportional hazards regression model with the following covariates: treatment group and volume of T2 lesions on screening MRI. The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for confirmed EDSS progression, i.e. hazard ratio = 1.||1.174|0.497|0.1604
74066014|NCT00185211|147684825|SUPERIORITY_OR_OTHER|||||||0.888||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|non-parametric ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||"The null hypothesis H0: The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms was tested against the alternative hypothesis HA: The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms using a non-parametric analysis of covariance (ANCOVA)."||||0.8880
74066015|NCT00185211|147684825|SUPERIORITY_OR_OTHER|||||||0.3832||95.0|||||ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||"The null hypothesis H0: The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms was tested against the alternative hypothesis HA: The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms using a parametric analysis of covariance (ANCOVA)."||||0.3832
74066016|NCT00185211|147684826|SUPERIORITY_OR_OTHER|||||||6e-06||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are identical for both treatment arms for all points in time t\>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are not identical for both treatment arms for some points in time t\>0."||||0.000006
74066017|NCT00185211|147684826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.583|||<|1e-06||95.0|0.474|0.718|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b versus initial placebo, i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to McDonald MS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for McDonald MS, i.e. hazard ratio = 1.||0.718|0.474|< 0.000001
74066018|NCT00185211|147684827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.1265||95.0|0.595|1.066||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Andersen-Gill Model|Covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|The time to recurrent relapses was modelled by an extension of Cox's PH regression model (Andersen-Gill Model) for recurrent events with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for recurrent relapses, i.e. hazard ratio = 1.||1.066|0.595|0.1265
74066019|NCT00185211|147684828|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7971||||0.0141||95.0|0.665|0.9554||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear Poisson regression|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Risk Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Relapse rate was analyzed by a generalized linear Poisson regression model with individual relapse counts as dependent variable, covariates: treatment arm, steroid use during first event, onset of disease and categorized number of T2 lesions at screening and offset variable natural log of time (in years) as difference between last clinical visit and baseline visit. The treatment effect on the relapse rate was of primary interest.||0.9554|0.6650|0.0141
74066020|NCT00185211|147684829|SUPERIORITY_OR_OTHER|||||||0.6078||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||"The null hypothesis H0: The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is identical for both treatment arms was tested against the alternative hypothesis HA: The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is not the same in the two treatment groups based on a non-parametric analysis of covariance (ANCOVA)."||||0.6078
74066021|NCT00185211|147684829|SUPERIORITY_OR_OTHER|||||||0.8245||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||"The null hypothesis H0: The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are identical for both treatment arms was tested against the alternative hypothesis HA: The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are not the same in the two treatment groups based on a non-parametric analysis of covariance (ANCOVA)."||||0.8245
74066022|NCT00185211|147684830|SUPERIORITY_OR_OTHER|||||||0.0062||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: number of Gd-enhancing lesions on T1 at screening||"The null hypothesis H0: The distribution of the cumulative number of newly active lesions at month 60 adjusted for the number of Gadolinium (Gd)-enhancing lesions on T1 at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.0062
74066023|NCT00185211|147684830|SUPERIORITY_OR_OTHER||Relative effect size|0.7351||||0.0435||95.0|0.5436|0.994||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear model|Distribution: negative binomial distribution; covariate: number of Gd-enhancing lesions on T1 at screening|The direction of comparison is initial IFNB-1b versus initial placebo.|Assuming that the cumulative number of newly active lesions at month 60 follows a negative binomial distribution, a generalized linear model (logarithmic link function, covariate: number of Gd-enhancing lesions on T1 at BENEFIT screening) was set up in order to analyze the treatment effect on that MRI outcome.||0.9940|0.5436|0.0435
74066024|NCT00185211|147684831|SUPERIORITY_OR_OTHER|||||||0.7801||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: T2 lesion volume at screening||"The null hypothesis H0: The distribution of the absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.7801
74066025|NCT00185211|147684831|SUPERIORITY_OR_OTHER|||||||0.9408||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: T2 lesion volume at screening||"The null hypothesis H0: The mean absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.9408
74066026|NCT00185211|147684832|SUPERIORITY_OR_OTHER|||||||0.6619||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Volume of black holes at screening||"The null hypothesis H0: The distribution of the absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.6619
74066027|NCT00185211|147684832|SUPERIORITY_OR_OTHER|||||||0.8558||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Volume of black holes at screening||"The null hypothesis H0: The mean absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.8558
74066028|NCT00185211|147684833|SUPERIORITY_OR_OTHER|||||||0.1208||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Brain volume at screening||"The null hypothesis H0: The distribution of the percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.1208
73883178|NCT01194830|147300374|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0002||95.0|-0.84|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.84|0.0002
73883179|NCT01194830|147300375|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0003||95.0|-0.85|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.85|0.0003
74066029|NCT00185211|147684833|SUPERIORITY_OR_OTHER|||||||0.0719||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Brain volume at screening||"The null hypothesis H0: The mean percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.0719
74066030|NCT02462382|147684834|EQUIVALENCE|The univariate analyses were conducted using Independent t-Tests for continuous variables and Fisher Exact Tests or Chi-Square Tests of Independence for categorical comparisons.|Fisher Exact Tests|0.041||||0.006|TWO_SIDED|||||POD 1 1cm incision.|Chi-squared|||Comparisons of pain scores using a Visual Analog Scale (VAS) based on Post-Operative Day (POD).||||.006
74066031|NCT00409188|147684887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.893||||0.1566|TWO_SIDED|95.0|0.763|1.044|||Regression, Cox|||||1.044|0.763|0.1566
74066032|NCT00409188|147684888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.845||||0.0226|TWO_SIDED|95.0|0.732|0.977|||Regression, Cox|||||0.977|0.732|0.0226
73883180|NCT01194830|147300376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.063||||0.001|TWO_SIDED|95.0|1.764|9.358|||Regression, Logistic|||||9.358|1.764|0.0010
73883181|NCT01194830|147300377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.433||||0.0352|TWO_SIDED|95.0|1.124|26.26|||Regression, Logistic|||||26.260|1.124|0.0352
73883182|NCT01194830|147300378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.951||||0.0003|TWO_SIDED|95.0|1.651|5.274|||Regression, Logistic|||||5.274|1.651|0.0003
74066033|NCT00409188|147684889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.0528|TWO_SIDED|95.0|0.752|1.002|||Regression, Cox|||||1.002|0.752|0.0528
74066034|NCT02257632|147684898|SUPERIORITY||Mean Difference (Final Values)|-14.98|||<|0.0001|TWO_SIDED|95.0|-19.64|-10.32||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all other patients|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate||||-10.32|-19.64|<0.0001
73883183|NCT01194830|147300379|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|7.2||0.0972||95.0|-26.1|2.2|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and number of other Oral Antidiabetic Drugs||||2.2|-26.1|0.0972
73883184|NCT01194830|147300380|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|24.45||0.9368||95.0|-53.8|49.86|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline 2-hour PPG, and number of other Oral Antidiabetic Drugs||||49.86|-53.80|0.9368
73883185|NCT03284710|147300415|OTHER|||||||0.358||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2||||0.358
73883186|NCT03284710|147300415|OTHER|||||||1||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2||||1.000
73883187|NCT03284710|147300415|OTHER|||||||0.361||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2||||0.361
74066035|NCT02257632|147684899|SUPERIORITY||Mean Difference (Final Values)|-11.46|||<|0.0001|TWO_SIDED|95.0|-15.98|-6.94||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all the patients with values|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate||||-6.94|-15.98|< 0.0001
74066036|NCT01859390|147684907|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.46|TWO_SIDED|95.0|-0.49|0.22|||t-test, 2 sided|||Two-sample T-test||0.22|-0.49|0.460
74066037|NCT01859390|147684907|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.325|TWO_SIDED|95.0|-0.513|0.173|||Regression, Linear||"Regression Model predictors include: AquADEKs-2 arm, Age \>=18 years, Sex, Screening FEV1%Predicted \>70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The estimated value is the mean difference between groups for 16 week change in log10 MPO."|||0.173|-0.513|0.325
74066038|NCT01859390|147684908|SUPERIORITY||Difference in Proportions-SAE incidence|-12.9||||0.302|TWO_SIDED|95.0|-32.1|7.8|||Fisher Exact|||||7.8|-32.1|0.302
74066039|NCT01859390|147684909|SUPERIORITY||Rate Ratio|0.94||||0.486|TWO_SIDED|95.0|0.78|1.13|||Poisson Model|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.||1.13|0.78|0.486
74066040|NCT01859390|147684909|SUPERIORITY|Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.|Rate Ratio|0.74||||0.269|TWO_SIDED|95.0|0.43|1.26|||Poisson Regression|||||1.26|0.43|0.269
74066041|NCT01859390|147684910|SUPERIORITY|Two sample T-test|Median Difference (Final Values)|1.43||||0.4463|TWO_SIDED|95.0|-2.3|5.16|||t-test, 2 sided|||||5.16|-2.30|0.4463
74066042|NCT01859390|147684911|SUPERIORITY||Median Difference (Final Values)|0.04||||0.8623|TWO_SIDED|95.0|-0.37|0.44|||t-test, 2 sided|||||0.44|-0.37|0.8623
73883188|NCT03284710|147300416|OTHER|||||||0.238||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2||||0.238
73883189|NCT03284710|147300416|OTHER|||||||0.893||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2||||0.893
74066043|NCT01859390|147684912|SUPERIORITY||Cox Proportional Hazard|0.536||||0.0534|TWO_SIDED|95.0|0.284|1.009||Not adjusted for multiple comparisons. Alpha at 0.05.|Regression, Cox||"Cox model parameters include: AquADEKs-2 arm, Age \>=18 years, Sex, Screening FEV1 % Predicted \>70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The parameter of interest is the Hazard Ratio comparing the AquADEKs-2 arm to the control arm."|||1.009|0.284|0.0534
73883190|NCT03284710|147300416|OTHER|||||||0.411||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2||||0.411
74066044|NCT01859390|147684913|SUPERIORITY||Rate Ratio|0.72||||0.1731|TWO_SIDED|95.0|0.44|1.16|||Poisson Model|||Rate Ratio for PEx calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months in the AquADEKs-2 group was 148 and in the Control group was 147.||1.16|0.44|0.1731
74066045|NCT01859390|147684914|SUPERIORITY|Difference in Proportions|Mean Difference (Final Values)|-14.8||||0.2363|TWO_SIDED|95.0|-35.1|7.4||Not adjusted for multiple comparisons. Alpha at 0.05.|Fisher Exact|||||7.4|-35.1|0.2363
74066046|NCT01859390|147684915|SUPERIORITY|Difference in Proportions|Median Difference (Final Values)|-15.7||||0.19|TWO_SIDED|95.0|-34.5|4.8|||Fisher Exact|||||4.8|-34.5|0.1900
74066047|NCT01084005|147684923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.81|-0.48|||ANCOVA|||||-0.48|-0.81|<0.0001
73883191|NCT03284710|147300417|OTHER|||||||1||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3||||1.000
73883192|NCT03284710|147300417|OTHER|||||||0.044||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3||||0.044
73883193|NCT03284710|147300417|OTHER|||||||0.045||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3||||0.045
73883194|NCT03284710|147300418|OTHER|||||||0.215||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3||||0.215
74066048|NCT01084005|147684924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.45|-0.24|||ANCOVA|||||-0.24|-0.45|<0.0001
74066049|NCT01084005|147684925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.71|-0.43|||ANCOVA|||||-0.43|-0.71|<0.0001
74066050|NCT01084005|147684926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.77|-0.47|||ANCOVA|||||-0.47|-0.77|<0.0001
74066051|NCT01084005|147684927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001||95.0|-30.2|-11.2|||ANCOVA|||||-11.2|-30.2|<0.0001
74066052|NCT01084005|147684928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001||95.0|-24.7|-12.6|||Mixed Models Analysis|||||-12.6|-24.7|<0.0001
74066053|NCT01084005|147684929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-28.1|-14.8|||Mixed Models Analysis|||||-14.8|-28.1|<0.0001
74066054|NCT01084005|147684930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001||95.0|-29.8|-13.4|||Mixed Models Analysis|||||-13.4|-29.8|<0.0001
74066055|NCT01084005|147684931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.319|||<|0.0001||95.0|3.321|20.837|||Regression, Logistic|||||20.837|3.321|<0.0001
74066056|NCT01084005|147684934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.214||||0.0048|TWO_SIDED|95.0|0.073|0.625|||Regression, Logistic|||Lina 5 mg qd vs Placebo||0.625|0.073|0.0048
74066057|NCT00549198|147684935|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.435
74066058|NCT00549198|147684936|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, age group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.057
74066059|NCT00549198|147684937|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.060
74066060|NCT00549198|147684938|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline GFR by CG\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.186
74066061|NCT00549198|147684939|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline GFR by CG\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.413
74066062|NCT00549198|147684940|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, baseline CD4, treatment\*visit, baseline GFR by CG\*visit, baseline BMI\*visit and baseline CD4\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.315
74066063|NCT00549198|147684947|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
73883195|NCT03284710|147300418|OTHER|||||||0.683||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3||||0.683
73883196|NCT03284710|147300418|OTHER|||||||0.322||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3||||0.322
74066064|NCT00549198|147684948|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, country group, treatment\*visit, baseline hip BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
74066065|NCT00549198|147684949|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.036
74066066|NCT00549198|147684950|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment\*visit, baseline hip BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|Correlation matrix for within-subject errors is unstructured.||||||<0.001
74066067|NCT00549198|147684951|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|correlation matrix for within-subject errors is unstructured.||||||0.112
74066068|NCT00549198|147684952|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment\*visit, baseline hip BMD\*visit, and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
74066069|NCT00549198|147684985|SUPERIORITY_OR_OTHER|||||||0.3025||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||0.3025
74066070|NCT00549198|147684986|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
74066071|NCT00549198|147684987|SUPERIORITY_OR_OTHER|||||||0.3323||95.0||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||0.3323
74066072|NCT00549198|147684988|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
74066073|NCT00549198|147684989|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from ana ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
74066074|NCT00549198|147684990|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||The model includes the following covariates: treatment, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0019
73883197|NCT00910104|147300501|SUPERIORITY||Hazard Ratio (HR)|8.6|||=|0.001|TWO_SIDED|95.0|2.0|37.3||All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\<0.05 was established as an a priori threshold for statistical significance.|Regression, Cox|||The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \[DB\]\<=2 mg/dL). Crude (unadjusted) hazard ratios were estimated using proportional hazard regression. Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).||37.3|2.0|=0.001
73883198|NCT00910104|147300501|SUPERIORITY||Hazard Ratio (HR)|17.4||||0.001|TWO_SIDED|95.0|3.7|83.0||All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\<0.05 was established as an a priori threshold for statistical significance.|Regression, Cox|||The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \[DB\]\<=2 mg/dL). Adjusted hazard ratios were estimated using proportional hazard regression adjusted for baseline covariates (including duration of parenteral nutrition (PN) and baseline DB). Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).||83|3.7|0.001
73883199|NCT00910104|147300501|OTHER||||||<|0.0001|||||||Fisher Exact|||Comparison of proportion with reversal of cholestasis (direct bilirubin \<=2.0 mg/dL).||||<0.0001
73883200|NCT03583099|147300502|SUPERIORITY||Difference in proportion|4.0||||0.47|TWO_SIDED|95.0|-6.9|15.0|||generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.0|-6.9|0.47
73883201|NCT03583099|147300503|SUPERIORITY||Difference in proportion|10.4||||0.05|TWO_SIDED|95.0|0.1|20.7|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||20.7|0.1|0.05
73883202|NCT03583099|147300504|SUPERIORITY||Difference in proportion|1.3||||0.75|TWO_SIDED|95.0|-6.7|9.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.2|-6.7|0.75
73883203|NCT03583099|147300505|SUPERIORITY||Difference in proportion|-2.7||||0.54|TWO_SIDED|95.0|-11.5|6.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||6.1|-11.5|0.54
73883204|NCT03583099|147300506|SUPERIORITY||Difference in proportion|5.1||||0.16|TWO_SIDED|95.0|-2.1|12.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.3|-2.1|0.16
74066075|NCT00549198|147684991|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0019
73883205|NCT03583099|147300507|SUPERIORITY||Difference in proportion|-0.6||||0.82|TWO_SIDED|95.0|-6.4|5.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.1|-6.4|0.82
73883206|NCT03583099|147300508|SUPERIORITY||Difference in proportion|-6.3||||0.06|TWO_SIDED|95.0|-13.0|0.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.4|-13.0|0.06
74066076|NCT00549198|147684992|SUPERIORITY_OR_OTHER|||||||0.0266||95.0||||The model includes the following covariates: treatment, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0266
74066077|NCT04229303|147685019|OTHER||Slope|0.62|||<|0.0001|TWO_SIDED|90.0|0.424|0.821|||General power constant model|||Statistics for Voriconazole AUC0-t||0.821|0.424|<0.0001
73883207|NCT03583099|147300509|SUPERIORITY||Difference in proportion|-2.5||||0.68|TWO_SIDED|95.0|-14.5|9.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||9.5|-14.5|0.68
73883208|NCT03583099|147300510|SUPERIORITY||Difference in proportion|13.3||||0.19|TWO_SIDED|95.0|-6.72|33.38|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||33.38|-6.72|0.19
73883209|NCT03583099|147300511|SUPERIORITY||Difference in proportion|0.85||||0.93|TWO_SIDED|95.0|-17.82|19.52|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||19.52|-17.82|0.93
73883210|NCT03583099|147300512|SUPERIORITY||Difference in proportion|6.83||||0.45|TWO_SIDED|95.0|-10.84|24.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||24.50|-10.84|0.45
74066078|NCT04229303|147685019|OTHER||Slope|1.21||||0.0363|TWO_SIDED|90.0|1.05|1.362|||General power linear model|||Statistics for Voriconazole AUC0-t||1.362|1.050|0.0363
74066079|NCT04229303|147685019|OTHER||Geometric mean difference|13.48|||<|0.0001|TWO_SIDED|90.0|10.096|17.994|||ANOVA|||Statistics for Voriconazole AUC0-t, 40mg vs 5mg||17.994|10.096|<0.0001
74066080|NCT04229303|147685019|OTHER||Slope|1.85|||<|0.0001|TWO_SIDED|90.0|1.728|1.963|||General power constant model|||Statistics for N-oxide Voriconazole AUC0-t||1.963|1.728|<0.0001
74066081|NCT04229303|147685019|OTHER||Slope|0.87||||0.0201|TWO_SIDED|90.0|0.789|0.96|||General power linear model|||Statistics for N-oxide Voriconazole AUC0-t||0.960|0.789|0.0201
74066082|NCT04229303|147685019|OTHER||Geometric mean difference|6.16|||<|0.0001|TWO_SIDED|90.0|5.253|7.217|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t, 40mg vs 5mg||7.217|5.253|<0.0001
74066083|NCT04229303|147685019|OTHER||Slope|0.81|||<|0.0001|TWO_SIDED|90.0|0.661|0.958|||General power constant model|||Statistics for Voriconazole AUC0-inf||0.958|0.661|<0.0001
74066084|NCT04229303|147685019|OTHER||Slope|1.12||||0.1278|TWO_SIDED|90.0|0.99|1.245|||General power linear model|||Statistics for Voriconazole AUC0-inf||1.245|0.990|0.1278
74066085|NCT04229303|147685019|OTHER||Geometric mean difference|9.43|||<|0.0001|TWO_SIDED|90.0|6.834|13.012|||ANOVA|||Statistics for Voriconazole AUC0-inf, 40mg vs 5mg||13.012|6.834|<0.0001
74066086|NCT04229303|147685019|OTHER||Slope|1.98|||<|0.0001|TWO_SIDED|90.0|1.86|2.106|||General power constant model|||Statistics for N-oxide Voriconazole AUC0-inf||2.106|1.860|<0.0001
74066087|NCT04229303|147685019|OTHER||Slope|0.79||||0.0082|TWO_SIDED|90.0|0.67|0.912|||General power linear model|||Statistics for N-oxide Voriconazole AUC0-inf||0.912|0.670|0.0082
73883211|NCT03583099|147300513|SUPERIORITY||Difference in proportion|7.6||||0.41|TWO_SIDED|95.0|-10.58|25.78|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.78|-10.58|0.41
73883212|NCT03583099|147300514|SUPERIORITY||Difference in proportion|1.85||||0.81|TWO_SIDED|95.0|-13.17|16.88|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.88|-13.17|0.81
74066088|NCT04229303|147685019|OTHER||Geometric mean difference|5.86|||<|0.0001|TWO_SIDED|90.0|4.627|7.421|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf, 40mg vs 5mg||7.421|4.627|<0.0001
74066089|NCT04229303|147685020|OTHER||Slope|0.12||||0.2575|TWO_SIDED|90.0|-0.06|0.308|||General power constant model|||Statistics for Voriconazole Cmax||0.308|-0.060|0.2575
74066090|NCT04229303|147685020|OTHER||Slope|1.17||||0.0491|TWO_SIDED|90.0|1.03|1.316|||General power linear model|||Statistics for Voriconazole Cmax||1.316|1.030|0.0491
74066091|NCT04229303|147685020|OTHER||Geometric mean difference|11.17|||<|0.0001|TWO_SIDED|90.0|8.435|14.803|||ANOVA|||Statistics for Voriconazole Cmax, 40mg vs 5mg||14.803|8.435|<0.0001
74066092|NCT04229303|147685020|OTHER||Slope|1.25|||<|0.0001|TWO_SIDED|90.0|1.135|1.363|||General power constant model|||Statistics for N-oxide Voriconazole Cmax||1.363|1.135|<0.0001
74066093|NCT04229303|147685020|OTHER||Slope|0.74||||0.0003|TWO_SIDED|90.0|0.634|0.843|||General power linear model|||Statistics for N-oxide Voriconazole Cmax||0.843|0.634|0.0003
74066094|NCT04229303|147685020|OTHER||Geometric mean difference|4.97|||<|0.0001|TWO_SIDED|90.0|3.946|6.254|||ANOVA|||Statistics for N-oxide Voriconazole Cmax, 40mg vs 5mg||6.254|3.946|<0.0001
74066095|NCT04229303|147685027|OTHER||Slope|2.0||||0.0004|TWO_SIDED|90.0|1.528|2.617|||ANOVA|||Statistics for Voriconazole AUC0-t Day 1||2.617|1.528|0.0004
74066096|NCT04229303|147685027|OTHER||Slope|4.73|||<|0.0001|TWO_SIDED|90.0|3.612|6.187|||ANOVA|||Statistics for Voriconazole AUC0-t Day 1||6.187|3.612|<0.0001
74066097|NCT04229303|147685027|OTHER||Slope|2.81|||<|0.0001|TWO_SIDED|90.0|2.017|3.925|||ANOVA|||Statistics for Voriconazole AUC0-t day 10||3.925|2.017|<0.0001
74066098|NCT04229303|147685027|OTHER||Slope|5.28|||<|0.0001|TWO_SIDED|90.0|3.783|7.361|||ANOVA|||Statistics for Voriconazole AUC0-t Day 10||7.361|3.783|<0.0001
74066099|NCT04229303|147685027|OTHER||Slope|1.97|||<|0.0001|TWO_SIDED|90.0|1.615|2.396|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 1||2.396|1.615|<0.0001
74066100|NCT04229303|147685027|OTHER||Slope|5.09|||<|0.0001|TWO_SIDED|90.0|4.178|6.196|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 1||6.196|4.178|<0.0001
74066101|NCT04229303|147685027|OTHER||Slope|2.45||||0.0002|TWO_SIDED|90.0|1.791|3.349|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 10||3.349|1.791|0.0002
74066102|NCT04229303|147685027|OTHER||Slope|4.6|||<|0.0001|TWO_SIDED|90.0|3.365|6.294|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 10||6.294|3.365|<0.0001
74066103|NCT04229303|147685027|OTHER||Slope|1.99||||0.0005|TWO_SIDED|90.0|1.524|2.602|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 1||2.602|1.524|0.0005
74066104|NCT04229303|147685027|OTHER||Slope|4.58|||<|0.0001|TWO_SIDED|90.0|3.505|5.984|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 1||5.984|3.505|<0.0001
74066105|NCT04229303|147685027|OTHER||Slope|2.65||||0.0003|TWO_SIDED|90.0|1.851|3.781|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 10||3.781|1.851|0.0003
74066106|NCT04229303|147685027|OTHER||Slope|5.04|||<|0.0001|TWO_SIDED|90.0|3.587|7.088|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 10||7.088|3.587|<0.0001
74066107|NCT04229303|147685027|OTHER||Slope|1.93|||<|0.0001|TWO_SIDED|90.0|1.569|2.384|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 1||2.384|1.569|<0.0001
74066108|NCT04229303|147685027|OTHER||Slope|4.56|||<|0.0001|TWO_SIDED|90.0|3.608|5.759|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 1||5.759|3.608|<0.0001
74066109|NCT04229303|147685027|OTHER||Slope|2.4||||0.0007|TWO_SIDED|90.0|1.694|3.402|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 10||3.402|1.694|0.0007
74066110|NCT04229303|147685027|OTHER||Slope|4.22|||<|0.0001|TWO_SIDED|90.0|2.975|5.974|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 10||5.974|2.975|<0.0001
74066111|NCT04229303|147685028|OTHER||Slope|2.03||||0.0003|TWO_SIDED|90.0|1.562|2.65|||ANOVA|||Statistics for Voriconazole Cmax Day 1||2.650|1.562|0.0003
74066112|NCT04229303|147685028|OTHER||Slope|4.87|||<|0.0001|TWO_SIDED|90.0|3.74|6.345|||ANOVA|||Statistics for Voriconazole Cmax Day 1||6.345|3.740|<0.0001
74066113|NCT04229303|147685028|OTHER||Slope|2.67|||<|0.0001|TWO_SIDED|90.0|2.081|3.429|||ANOVA|||Statistics for Voriconazole Cmax Day 10||3.429|2.081|<0.0001
74066114|NCT04229303|147685028|OTHER||Slope|5.97|||<|0.0001|TWO_SIDED|90.0|4.647|7.658|||ANOVA|||Statistics for Voriconazole Cmax Day 10||7.658|4.647|<0.0001
74066115|NCT04229303|147685028|OTHER||Slope|2.02|||<|0.0001|TWO_SIDED|90.0|1.688|2.406|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 1||2.406|1.688|<0.0001
74066116|NCT04229303|147685028|OTHER||Slope|4.73|||<|0.0001|TWO_SIDED|90.0|3.964|5.65|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 1||5.650|3.964|<0.0001
74066117|NCT04229303|147685028|OTHER||Slope|2.12|||<|0.0001|TWO_SIDED|90.0|1.655|2.711|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 10||2.711|1.655|<0.0001
74066118|NCT04229303|147685028|OTHER||Slope|4.01|||<|0.0001|TWO_SIDED|90.0|3.135|5.135|||ANOVA|||Statistics for N-oxide Voriconazole Cmax day 10||5.135|3.135|<0.0001
74066119|NCT04229303|147685049|OTHER||Geometric mean ratio|0.13|||||TWO_SIDED|90.0|0.107|0.146||||||Part 3 - ZP-059 20mg: Oral Voriconazole (200mg VFEND)||0.146|0.107|
74066120|NCT04229303|147685049|OTHER||Geometric mean ratio|2.1|||||TWO_SIDED|90.0|1.545|2.853||||||ZP-059 20mg: Part 3 / Part 1||2.853|1.545|
74066121|NCT04229303|147685049|OTHER||Geometric mean ratio|2.63|||||TWO_SIDED|90.0|1.953|3.544||||||ZP-059 20mg: Part 3 / Part 2 Day 1||3.544|1.953|
74066122|NCT04229303|147685049|OTHER||Geometric mean ratio|1.87|||||TWO_SIDED|90.0|1.386|2.52||||||ZP-059 20mg: Part 3 / Part 2 Day 10||2.520|1.386|
74066123|NCT04229303|147685050|OTHER||Geometric mean ratio|0.07|||||TWO_SIDED|90.0|0.059|0.075||||||Part 3 ZP-059 20mg: Oral Voriconazole (200mg VFEND®)||0.075|0.059|
74066124|NCT04229303|147685050|OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|90.0|0.85|1.891||||||ZP-059 20mg: Part 3 / Part 1||1.891|0.850|
74066125|NCT04229303|147685050|OTHER||Geometric mean ratio|2.63|||||TWO_SIDED|90.0|1.953|3.544||||||ZP-059 20mg: Part 3 / Part 2 Day 1||3.544|1.953|
74066126|NCT04229303|147685050|OTHER||Geometric mean ratio|1.87|||||TWO_SIDED|90.0|1.386|2.52||||||ZP-059 20mg: Part 3 / Part 2 Day 10||2.520|1.386|
74066127|NCT00606684|147685051|SUPERIORITY_OR_OTHER||Least squares mean difference|0.092|||<|0.001|TWO_SIDED|95.0|0.039|0.144|||ANCOVA|||||0.144|0.039|<0.001
74066128|NCT00606684|147685051|SUPERIORITY_OR_OTHER||Least squares mean difference|0.098|||<|0.001|TWO_SIDED|95.0|0.046|0.15|||ANCOVA|||||0.150|0.046|<0.001
74066129|NCT00606684|147685051|SUPERIORITY_OR_OTHER||Least squares mean difference|0.11|||<|0.001|TWO_SIDED|95.0|0.057|0.162|||ANCOVA|||||0.162|0.057|<0.001
74066130|NCT00606684|147685051|SUPERIORITY_OR_OTHER||Least squares mean difference|0.137|||<|0.001|TWO_SIDED|95.0|0.085|0.19|||ANCOVA|||||0.190|0.085|<0.001
74066131|NCT00606684|147685051|SUPERIORITY_OR_OTHER||Least squares mean difference|0.165|||<|0.001|TWO_SIDED|95.0|0.112|0.217|||ANCOVA|||||0.217|0.112|<0.001
74066132|NCT02144259|147685055|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GEE|||Because the expected amount of postpartum weight loss in non-breastfeeding women is not documented in the literature, we chose a sample size that would enable us to detect a one standard deviation difference in weight loss between the 3 groups at the primary 6 month endpoint. We used generalized estimating equations (GEEs) to test differences among all 3 groups over all the study periods.||||<0.05
74066133|NCT02144259|147685057|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
74066134|NCT04169282|147685075|SUPERIORITY|||||||0.108|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.108
74066135|NCT04169282|147685076|SUPERIORITY|||||||0.003|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.003
74066136|NCT04169282|147685077|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.025
74066137|NCT00621686|147685084|SUPERIORITY_OR_OTHER|||||||0.069|||||||Log Rank|||||||0.069
74066138|NCT01170364|147685099|SUPERIORITY||||||<|0.004|||||||paired sample t-test, two tailed|||||||<0.004
74066139|NCT01381900|147685100|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.644|-0.367|||ANCOVA|||||-0.367|-0.644|<0.001
74066140|NCT01381900|147685100|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.731|-0.453|||ANCOVA|||||-0.453|-0.731|<0.001
74066141|NCT01381900|147685101|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.173|<|0.001|TWO_SIDED|95.0|-1.375|-0.694|||ANCOVA|||||-0.694|-1.375|<0.001
74066142|NCT01381900|147685101|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|0.173|<|0.001|TWO_SIDED|95.0|-1.769|-1.089|||ANCOVA|||||-1.089|-1.769|<0.001
74066143|NCT01381900|147685102|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.7|-1.6|||ANCOVA|||||-1.6|-2.7|<0.001
74066144|NCT01381900|147685102|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.9|-1.8|||ANCOVA|||||-1.8|-2.9|<0.001
74066145|NCT01381900|147685103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.26|||||TWO_SIDED|95.0|2.09|5.09|||Regression, Logistic|||||5.09|2.09|
74066146|NCT01381900|147685103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.99|||||TWO_SIDED|95.0|2.55|6.27|||Regression, Logistic|||||6.27|2.55|
74066147|NCT01381900|147685104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55|||||TWO_SIDED|95.0|1.45|4.48|||Regression, Logistic|||||4.48|1.45|
74066148|NCT01381900|147685104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29|||||TWO_SIDED|95.0|1.88|5.75|||Regression, Logistic|||||5.75|1.88|
73883213|NCT03583099|147300515|SUPERIORITY||Difference in proportion|8.01||||0.51|TWO_SIDED|95.0|-15.38|31.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||31.40|-15.38|0.51
74066149|NCT01797120|147685163|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.02|TWO_SIDED|95.0|0.4|0.92|||Log Rank|Log rank test was stratified on ECOG performance status, measurable disease, and prior chemotherapy for metastatic disease||||0.92|0.40|0.02
74066150|NCT01797120|147685164|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
74066151|NCT01797120|147685165|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
74066152|NCT03840135|147685188|SUPERIORITY||Mean Difference (Final Values)|-0.22|||<|0.05|TWO_SIDED|95.0|-0.6|0.16|||t-test, 2 sided|||The value of δ = -0.52 days was considered as the boundary of superiority. The end of the fever period is considered to have an axillary body temperature of ≤36.9 ° C in two consecutive measurements (morning-evening / evening-morning).||0.16|-0.6|<0.05
74066153|NCT03840135|147685189|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
74066154|NCT03840135|147685190|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
74066155|NCT03840135|147685191|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
74066156|NCT03840135|147685192|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74066157|NCT03840135|147685193|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
74066158|NCT03840135|147685194|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
74066159|NCT03840135|147685197|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
73888302|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|60.2||||0.2558|TWO_SIDED|95.0|-44.1|164.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||164.4|-44.1|0.2558
74066160|NCT03840135|147685198|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
74066161|NCT01809314|147685212|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||The difference between Baseline and Month 4 was analyzed using the Wilcoxon signed-rank test.||||<0.0001
74066162|NCT01809314|147685213|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon signed-rank test|||Overall (all categories combined) change from Baseline in ECOG performance status at Month 4 was analyzed using Wilcoxon signed-rank test.||||0.001
74066163|NCT01684722|147685215|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.25|TWO_SIDED|95.0|-0.7|2.5|||Mixed Models Analysis|||||2.5|-0.7|0.25
74066164|NCT01684722|147685215|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.27|TWO_SIDED|95.0|-0.7|2.6|||Mixed Models Analysis|||||2.6|-0.7|0.27
74066165|NCT01684722|147685216|SUPERIORITY||Ratio of change from baseline, active to|0.99||||0.9|TWO_SIDED|95.0|0.84|1.17|||Mixed Models Analysis|||||1.17|0.84|0.90
74066166|NCT01684722|147685216|SUPERIORITY||Ratio of change from baseline, active to|0.96||||0.64|TWO_SIDED|95.0|0.81|1.14|||Mixed Models Analysis|||||1.14|0.81|0.64
74066167|NCT00219557|147685225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.1026|TWO_SIDED|95.0|0.49|1.17||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to 1 or 2) and extent of disease (locally advanced or metastatic).||1.170|0.490|0.1026
74066168|NCT00219557|147685236|SUPERIORITY_OR_OTHER||Difference in response rate|4.3||||0.661|TWO_SIDED|95.0|-4.0|12.7|||Fisher Exact|||Difference in percent of participants with overall response expressed as response rate, was used for calculation of 95% confidence interval (CI).||12.7|-4.0|0.661
74066169|NCT00219557|147685238|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9648||||0.4466|TWO_SIDED|95.0|0.54|1.73||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are ECOG performance status (less than equal to 1 or 2) and extent of disease (locally advanced or metastatic).||1.7300|0.5400|0.4466
74066170|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.44|||||TWO_SIDED|95.0|-19.06|2.19||||||For change in global QoL at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||2.19|-19.06|
74066171|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.02|||||TWO_SIDED|95.0|-15.4|3.36||||||For change in physical functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||3.36|-15.4|
74066172|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.32|||||TWO_SIDED|95.0|-23.77|5.12||||||For change in role functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.12|-23.77|
74066173|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.73|||||TWO_SIDED|95.0|-15.25|5.79||||||For change in emotional functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.79|-15.25|
74066174|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.11|||||TWO_SIDED|95.0|-15.83|5.61||||||For change in cognitive functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.61|-15.83|
74066175|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-18.72|12.06||||||For change in social functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||12.06|-18.72|
74066176|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.41|||||TWO_SIDED|95.0|-1.62|22.44||||||For change in fatigue at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.44|-1.62|
74066177|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|||||TWO_SIDED|95.0|-16.55|7.96||||||For change in nausea and vomiting at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||7.96|-16.55|
73883214|NCT03583099|147300516|SUPERIORITY||Difference in proportion|-10.34||||0.41|TWO_SIDED|95.0|-34.78|14.09|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.09|-34.78|0.41
73883215|NCT03583099|147300517|SUPERIORITY||Difference in proportion|-3.94||||0.76|TWO_SIDED|95.0|-31.03|23.16|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||23.16|-31.03|0.76
73883216|NCT03583099|147300518|SUPERIORITY||Difference in proportion|-0.76||||0.95|TWO_SIDED|95.0|-25.36|23.83|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||23.83|-25.36|0.95
73883217|NCT03583099|147300519|SUPERIORITY||Difference in means|-0.32||||0.55|TWO_SIDED|95.0|-2.01|1.36||The p-value is adjusted for baseline CAT score.|Mixed Models Analysis||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.36|-2.01|0.55
74066178|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.37|||||TWO_SIDED|95.0|-7.57|22.32||||||For change in pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.32|-7.57|
74066179|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.51|||||TWO_SIDED|95.0|-1.28|26.3||||||For change in dyspnea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||26.30|-1.28|
74066180|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|||||TWO_SIDED|95.0|-5.7|25.49||||||For change in insomnia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||25.49|-5.70|
74066181|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.63|||||TWO_SIDED|95.0|-4.81|32.07||||||For change in appetite loss at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||32.07|-4.81|
74066182|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.67|||||TWO_SIDED|95.0|-11.62|20.96||||||For change in constipation at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.96|-11.62|
73883218|NCT03583099|147300520|SUPERIORITY||Difference in proportion|8.7||||0.05|TWO_SIDED|95.0|-0.1|17.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.4|-0.1|0.05
74066183|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|95.0|-15.1|12.54||||||For change in diarrhea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||12.54|-15.1|
74066184|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.43|||||TWO_SIDED|95.0|-4.67|15.53||||||For change in financial difficulties at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||15.53|-4.67|
74066185|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.83|||||TWO_SIDED|95.0|-32.34|0.67||||||For change in global QoL at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||0.67|-32.34|
74066186|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|||||TWO_SIDED|95.0|-24.12|0.96||||||For change in physical functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||0.96|-24.12|
74066187|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.65|||||TWO_SIDED|95.0|-35.47|-1.83||||||For change in role functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||-1.83|-35.47|
74066188|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.92|||||TWO_SIDED|95.0|-29.16|1.32||||||For change in emotional functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||1.32|-29.16|
74066189|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|||||TWO_SIDED|95.0|-20.97|6.77||||||For change in cognitive functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||6.77|-20.97|
74066190|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.62|||||TWO_SIDED|95.0|-28.28|9.04||||||For change in social functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||9.04|-28.28|
74066191|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.14|||||TWO_SIDED|95.0|-1.27|33.54||||||For change in fatigue at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||33.54|-1.27|
74066192|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-18.78|15.18||||||For change in nausea and vomiting at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||15.18|-18.78|
74066193|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.59|||||TWO_SIDED|95.0|-3.22|36.39||||||For change in pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||36.39|-3.22|
74066194|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.39|||||TWO_SIDED|95.0|-5.68|26.47||||||For change in dyspnea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||26.47|-5.68|
73883219|NCT03583099|147300521|SUPERIORITY||Difference in proportion|1.81||||0.88|TWO_SIDED|95.0|-21.47|25.08|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.08|-21.47|0.88
74066195|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|||||TWO_SIDED|95.0|-20.19|23.36||||||For change in insomnia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||23.36|-20.19|
74066196|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.24|||||TWO_SIDED|95.0|-7.62|40.1||||||For change in appetite loss at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||40.1|-7.62|
74066197|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|||||TWO_SIDED|95.0|-17.49|23.02||||||For change in constipation at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||23.02|-17.49|
74066198|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87|||||TWO_SIDED|95.0|-16.29|22.03||||||For change in diarrhea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.03|-16.29|
74066199|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-9.81|20.92||||||For change in financial difficulties at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||20.92|-9.81|
74066200|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.97|||||TWO_SIDED|95.0|-19.52|7.57||||||For change in global QoL at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||7.57|-19.52|
74066201|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.64|||||TWO_SIDED|95.0|-19.75|8.46||||||For change in physical functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||8.46|-19.75|
73883220|NCT03583099|147300522|SUPERIORITY||Difference in proportion|-5.62||||0.53|TWO_SIDED|95.0|-23.21|11.97|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.97|-23.21|0.53
73883221|NCT03583099|147300523|SUPERIORITY||Difference in proportion|10.68||||0.24|TWO_SIDED|95.0|-7.27|28.63|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||28.63|-7.27|0.24
74066202|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.53|||||TWO_SIDED|95.0|-39.11|4.05||||||For change in role functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||4.05|-39.11|
74066203|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.25|||||TWO_SIDED|95.0|-26.5|2.0||||||For change in emotional functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||2.00|-26.5|
74066204|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.99|||||TWO_SIDED|95.0|-23.13|9.15||||||For change in cognitive functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||9.15|-23.13|
74066205|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.09|||||TWO_SIDED|95.0|-30.48|16.31||||||For change in social functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||16.31|-30.48|
74066206|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.88|||||TWO_SIDED|95.0|-5.86|27.63||||||For change in fatigue at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||27.63|-5.86|
74066207|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||||TWO_SIDED|95.0|-24.11|1.91||||||For change in nausea and vomiting at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||1.91|-24.11|
74066208|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.13|||||TWO_SIDED|95.0|-24.26|14.0||||||For change in pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||14.00|-24.26|
74066209|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.13|||||TWO_SIDED|95.0|-14.18|24.44||||||For change in dyspnea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.44|-14.18|
74066210|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.33|||||TWO_SIDED|95.0|-26.25|13.59||||||For change in insomnia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||13.59|-26.25|
74066211|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.03|||||TWO_SIDED|95.0|-15.26|33.32||||||For change in appetite loss at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||33.32|-15.26|
73883222|NCT03583099|147300524|SUPERIORITY||Difference in proportion|-13.55||||0.19|TWO_SIDED|95.0|-33.65|6.55|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.55|-33.65|0.19
74066212|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|||||TWO_SIDED|95.0|-25.71|26.82||||||For change in constipation at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||26.82|-25.71|
74066213|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|-24.07|28.01||||||For change in diarrhea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||28.01|-24.07|
74066214|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.48|||||TWO_SIDED|95.0|-5.89|24.86||||||For change in financial difficulties at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.86|-5.89|
74066215|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.01|||||TWO_SIDED|95.0|-43.19|3.17||||||For change in global QoL at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||3.17|-43.19|
74066216|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.57|||||TWO_SIDED|95.0|-27.24|10.1||||||For change in physical functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||10.10|-27.24|
74066217|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.07|||||TWO_SIDED|95.0|-41.1|8.96||||||For change in role functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||8.96|-41.10|
74066218|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.11|||||TWO_SIDED|95.0|-42.72|-5.5||||||For change in emotional functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||-5.50|-42.72|
74066219|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|||||TWO_SIDED|95.0|-29.66|10.61||||||For change in cognitive functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||10.61|-29.66|
74066220|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.24|||||TWO_SIDED|95.0|-47.93|7.46||||||For change in social functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||7.46|-47.93|
74066221|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|3.23|46.77||||||For change in fatigue at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||46.77|3.23|
74066222|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.25|||||TWO_SIDED|95.0|-13.49|25.99||||||For change in nausea and vomiting at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||25.99|-13.49|
74066223|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.64|||||TWO_SIDED|95.0|-7.12|46.41||||||For change in pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||46.41|-7.12|
73883223|NCT03583099|147300525|SUPERIORITY||Difference in proportion|0.38||||0.95|TWO_SIDED|95.0|-12.5|13.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.27|-12.50|0.95
74066224|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.02|||||TWO_SIDED|95.0|0.38|43.66||||||For change in dyspnea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||43.66|0.38|
74066225|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.12|||||TWO_SIDED|95.0|-18.49|38.73||||||For change in insomnia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||38.73|-18.49|
74066226|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-13.98|55.65||||||For change in appetite loss at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||55.65|-13.98|
74066227|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.9|||||TWO_SIDED|95.0|-19.02|42.83||||||For change in constipation at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.83|-19.02|
74066228|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.9|||||TWO_SIDED|95.0|-16.13|39.94||||||For change in diarrhea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||39.94|-16.13|
74066229|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-23.38|23.38||||||For change in financial difficulties at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||23.38|-23.38|
74066230|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.66|||||TWO_SIDED|95.0|-34.53|17.21||||||For change in global QoL at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups||17.21|-34.53|
74066231|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.98|||||TWO_SIDED|95.0|-52.01|26.04||||||For change in physical functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||26.04|-52.01|
74066232|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.32|||||TWO_SIDED|95.0|-71.87|19.24||||||For change in role functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||19.24|-71.87|
74066233|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.14|||||TWO_SIDED|95.0|-26.59|14.31||||||For change in emotional functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||14.31|-26.59|
74066234|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.99|||||TWO_SIDED|95.0|-35.46|11.48||||||For change in cognitive functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||11.48|-35.46|
74066235|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.04|||||TWO_SIDED|95.0|-20.97|49.04||||||For change in social functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||49.04|-20.97|
74066236|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.39|||||TWO_SIDED|95.0|-15.83|62.61||||||For change in fatigue at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||62.61|-15.83|
74066237|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|||||TWO_SIDED|95.0|-30.84|38.73||||||For change in nausea and vomiting at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||38.73|-30.84|
74066238|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.56|||||TWO_SIDED|95.0|-13.08|62.2||||||For change in pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||62.20|-13.08|
74066239|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|||||TWO_SIDED|95.0|-38.65|34.94||||||For change in dyspnea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||34.94|-38.65|
74066240|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.65|||||TWO_SIDED|95.0|-37.43|56.73||||||For change in insomnia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||56.73|-37.43|
74066241|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.16|||||TWO_SIDED|95.0|-71.22|97.54||||||For change in appetite loss at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||97.54|-71.22|
74066242|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.81|||||TWO_SIDED|95.0|-22.61|68.22||||||For change in constipation at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||68.22|-22.61|
74066243|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||||TWO_SIDED|95.0|-39.1|35.59||||||For change in diarrhea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||35.59|-39.10|
74066244|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.98|||||TWO_SIDED|95.0|1.09|46.86||||||For change in financial difficulties at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||46.86|1.09|
74066245|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.04|||||TWO_SIDED|95.0|-39.03|63.11||||||For change in global QoL at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||63.11|-39.03|
74066246|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.89|||||TWO_SIDED|95.0|-20.74|58.52||||||For change in physical functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||58.52|-20.74|
74066247|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.33|||||TWO_SIDED|95.0|-111.94|15.28||||||For change in role functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||15.28|-111.94|
74066248|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||||TWO_SIDED|95.0|-22.59|20.74||||||For change in emotional functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.74|-22.59|
74066249|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.22|||||TWO_SIDED|95.0|-24.98|39.43||||||For change in cognitive functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||39.43|-24.98|
74066250|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||||TWO_SIDED|95.0|-57.71|77.71||||||For change in social functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||77.71|-57.71|
74066251|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.04|||||TWO_SIDED|95.0|-58.87|24.79||||||For change in fatigue at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||24.79|-58.87|
74066252|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0|||||TWO_SIDED|95.0|-43.1|13.1||||||For change in nausea and vomiting at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||13.10|-43.10|
74066253|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.78|||||TWO_SIDED|95.0|-41.75|57.3||||||For change in pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||57.30|-41.75|
73883224|NCT03583099|147300526|SUPERIORITY||Difference in proportion|-6.97||||0.14|TWO_SIDED|95.0|-16.12|2.17|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.17|-16.12|0.14
74066254|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-53.79|20.46||||||For change in dyspnea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.46|-53.79|
74066255|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.11|||||TWO_SIDED|95.0|-73.14|30.92||||||For change in insomnia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||30.92|-73.14|
74066256|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.22|||||TWO_SIDED|95.0|-115.58|51.13||||||For change in appetite loss at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||51.13|-115.58|
74066257|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.33|||||TWO_SIDED|95.0|-18.6|125.26||||||For change in constipation at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||125.26|-18.60|
74066258|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.33|||||TWO_SIDED|95.0|-34.92|41.58||||||For change in diarrhea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||41.58|-34.92|
74066259|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.67|||||TWO_SIDED|95.0|-34.3|20.96||||||For change in financial difficulties at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.96|-34.3|
74066260|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-58.94|100.6||||||For change in global QoL at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||100.60|-58.94|
74066261|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.33|||||TWO_SIDED|95.0|-44.54|63.2||||||For change in physical functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||63.20|-44.54|
74066262|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|||||TWO_SIDED|95.0|-35.3|75.3||||||For change in role functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||75.30|-35.30|
74066263|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||||TWO_SIDED|95.0|-51.66|36.66||||||For change in emotional functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||36.66|-51.66|
74066264|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-36.06|69.39||||||For change in cognitive functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||69.39|-36.06|
74066265|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||||TWO_SIDED|95.0|-76.36|86.36||||||For change in social functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||86.36|-76.36|
74066266|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.78|||||TWO_SIDED|95.0|-77.63|42.08||||||For change in fatigue at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||42.08|-77.63|
74066267|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-62.33|28.99||||||For change in nausea and vomiting at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||28.99|-62.33|
74066268|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-79.59|96.26||||||For change in pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.26|-79.59|
73883225|NCT03583099|147300527|SUPERIORITY||Difference in proportion|-1.06||||0.87|TWO_SIDED|95.0|-13.39|11.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.27|-13.39|0.87
74066269|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-89.98|52.94||||||For change in dyspnea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||52.94|-89.98|
74066270|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0|||||TWO_SIDED|95.0|-133.08|93.08||||||For change in insomnia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||93.08|-133.08|
74066271|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.67|||||TWO_SIDED|95.0|-151.27|77.94||||||For change in appetite loss at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||77.94|-151.27|
74066272|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-72.58|65.91||||||For change in constipation at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||65.91|-72.58|
74066273|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.33|||||TWO_SIDED|95.0|-16.45|163.12||||||For change in diarrhea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||163.12|-16.45|
74066274|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-48.23|41.56||||||For change in financial difficulties at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||41.56|-48.23|
74066275|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.62|||||TWO_SIDED|95.0|-74.75|106.0||||||For change in global QoL at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||106.00|-74.75|
74066276|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-17.22|83.89||||||For change in physical functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||83.89|-17.22|
74066277|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.17|||||TWO_SIDED|95.0|-58.04|66.37||||||For change in role functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-58.04|
74066278|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||||TWO_SIDED|95.0|-28.19|38.61||||||For change in emotional functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||38.61|-28.19|
74066279|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.25|||||TWO_SIDED|95.0|-40.94|103.44||||||For change in cognitive functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||103.44|-40.94|
74066280|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.08|||||TWO_SIDED|95.0|-91.02|145.18||||||For change in social functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||145.18|-91.02|
74066281|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.28|||||TWO_SIDED|95.0|-99.46|68.9||||||For change in fatigue at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||68.90|-99.46|
74066282|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|||||TWO_SIDED|95.0|-69.69|19.69||||||For change in nausea and vomiting at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||19.69|-69.69|
74066283|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-77.4|77.4||||||For change in pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||77.40|-77.40|
74066284|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.29|||||TWO_SIDED|95.0|-82.89|54.32||||||For change in dyspnea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||54.32|-82.89|
74066285|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-87.02|78.69||||||For change in insomnia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||78.69|-87.02|
74066286|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|||||TWO_SIDED|95.0|-184.57|134.57||||||For change in appetite loss at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||134.57|-184.57|
74066287|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33|||||TWO_SIDED|95.0|-105.73|89.06||||||For change in constipation at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||89.06|-105.73|
74066288|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.17|||||TWO_SIDED|95.0|-29.72|188.06||||||For change in diarrhea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||188.06|-29.72|
74066289|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-57.74|49.41||||||For change in financial difficulties at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||49.41|-57.74|
74066290|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-39.62|72.95||||||For change in global QoL at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||72.95|-39.62|
74066291|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.62|||||TWO_SIDED|95.0|-6.42|61.66||||||For change in physical functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||61.66|-6.42|
74066292|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.19|||||TWO_SIDED|95.0|-29.28|81.66||||||For change in role functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||81.66|-29.28|
74066293|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57|||||TWO_SIDED|95.0|-63.74|56.6||||||For change in emotional functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||56.6|-63.74|
74066294|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.81|||||TWO_SIDED|95.0|-31.66|79.28||||||For change in cognitive functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||79.28|-31.66|
74066295|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||||TWO_SIDED|95.0|-53.82|110.96||||||For change in social functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.96|-53.82|
74066296|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.16|||||TWO_SIDED|95.0|-94.53|34.21||||||For change in fatigue at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||34.21|-94.53|
74066297|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-83.26|49.93||||||For change in nausea and vomiting at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||49.93|-83.26|
73883226|NCT03583099|147300528|SUPERIORITY||Difference in proportion|-1.8||||0.81|TWO_SIDED|95.0|-15.9|12.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.4|-15.9|0.81
74066298|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||||TWO_SIDED|95.0|-97.98|88.45||||||For change in pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||88.45|-97.98|
74066299|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-86.68|64.46||||||For change in dyspnea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||64.46|-86.68|
74066300|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.76|||||TWO_SIDED|95.0|-55.41|64.93||||||For change in insomnia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||64.93|-55.41|
74066301|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|||||TWO_SIDED|95.0|-129.86|110.82||||||For change in appetite loss at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.82|-129.86|
74066302|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.05|||||TWO_SIDED|95.0|-117.92|79.82||||||For change in constipation at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||79.82|-117.92|
74066303|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.19|||||TWO_SIDED|95.0|-6.75|159.13||||||For change in diarrhea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||159.13|-6.75|
74066304|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||||TWO_SIDED|95.0|-64.93|55.41||||||For change in financial difficulties at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||55.41|-64.93|
73883227|NCT03583099|147300529|SUPERIORITY||Difference in proportion|2.3||||0.63|TWO_SIDED|95.0|-7.2|11.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.8|-7.2|0.63
74066305|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.56|||||TWO_SIDED|95.0|-271.74|260.62||||||For change in global QoL at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||260.62|-271.74|
74066306|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.56|||||TWO_SIDED|95.0|-166.87|197.98||||||For change in physical functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||197.98|-166.87|
74066307|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-238.4|293.96||||||For change in role functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||293.96|-238.4|
74066308|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-275.22|241.89||||||For change in emotional functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||241.89|-275.22|
74066309|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-307.94|319.05||||||For change in cognitive functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||319.05|-307.94|
74066310|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-238.4|293.96||||||For change in social functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||293.96|-238.40|
74066311|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.81|||||TWO_SIDED|95.0|-215.01|244.64||||||For change in fatigue at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||244.64|-215.01|
74066312|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-302.38|324.6||||||For change in nausea and vomiting at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||324.60|-302.38|
74066313|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-305.85|383.63||||||For change in pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||383.63|-305.85|
74066314|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-355.85|333.63||||||For change in dyspnea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||333.63|-355.85|
74066315|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.22|||||TWO_SIDED|95.0|-322.52|366.97||||||For change in insomnia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||366.97|-322.52|
74066316|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-208.53|297.42||||||For change in appetite loss at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||297.42|-208.53|
74066317|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-165.61|165.61||||||For change in constipation at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||165.61|-165.61|
74066318|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.78|||||TWO_SIDED|95.0|-17.84|173.39||||||For change in diarrhea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||173.39|-17.84|
74066319|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-106.73|84.5||||||For change in financial difficulties at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||84.5|-106.73|
74066320|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.17|||||TWO_SIDED|95.0|-512.66|404.33||||||For change in global QoL at EoS, mean change difference was used to compare the two treatment groups.||404.33|-512.66|
74066321|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.0|||||TWO_SIDED|95.0|-143.36|3.36||||||For change in physical functioning at EoS, mean change difference was used to compare the two treatment groups.||3.36|-143.36|
73883228|NCT03583099|147300530|SUPERIORITY||Difference in proportion|5.8||||0.17|TWO_SIDED|95.0|-2.5|14.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.2|-2.5|0.17
74066322|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.33|||||TWO_SIDED|95.0|-400.13|333.46||||||For change in role functioning at EoS, mean change difference was used to compare the two treatment groups.||333.46|-400.13|
74066323|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.67|||||TWO_SIDED|95.0|-591.86|508.53||||||For change in emotional functioning at EoS, mean change difference was used to compare the two treatment groups.||508.53|-591.86|
74066324|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.67|||||TWO_SIDED|95.0|-66.67|-66.67||||||For change in cognitive functioning at EoS, mean change difference was used to compare the two treatment groups.||-66.67|-66.67|
74066325|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.33|||||TWO_SIDED|95.0|-450.13|283.46||||||For change in social functioning at EoS, mean change difference was used to compare the two treatment groups.||283.46|-450.13|
74066326|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.67|||||TWO_SIDED|95.0|-177.86|311.2||||||For change in fatigue at EoS, mean change difference was used to compare the two treatment groups.||311.2|-177.86|
74066327|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-333.46|400.13||||||For change in nausea and vomiting at EoS, mean change difference was used to compare the two treatment groups.||400.13|-333.46|
74066328|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-1258.79|1308.79||||||For change in pain at EoS, mean change difference was used to compare the two treatment groups.||1308.79|-1258.79|
74066329|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in dyspnea at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
74066330|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-700.26|766.93||||||For change in insomnia at EoS, mean change difference was used to compare the two treatment groups.||766.93|-700.26|
73883229|NCT03583099|147300531|SUPERIORITY||Difference in proportion|-2.9||||0.58|TWO_SIDED|95.0|-13.0|7.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.3|-13.0|0.58
73883230|NCT03583099|147300532|SUPERIORITY||Difference in proportion|-0.6||||0.89|TWO_SIDED|95.0|-8.3|7.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.1|-8.3|0.89
74066331|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|95.0|-1050.39|1150.39||||||For change in appetite loss at EoS, mean change difference was used to compare the two treatment groups.||1150.39|-1050.39|
73883231|NCT03583099|147300533|SUPERIORITY||Difference in proportion|-3.9||||0.16|TWO_SIDED|95.0|-9.2|1.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.5|-9.2|0.16
74066332|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-1850.65|1817.32||||||For change in constipation at EoS, mean change difference was used to compare the two treatment groups.||1817.32|-1850.65|
74066333|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-700.26|766.93||||||For change in diarrhea at EoS, mean change difference was used to compare the two treatment groups.||766.93|-700.26|
74066334|NCT00219557|147685240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-383.46|350.13||||||For change in financial difficulties at EoS, mean change difference was used to compare the two treatment groups.||350.13|-383.46|
74066335|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||||TWO_SIDED|95.0|-10.11|15.29||||||For change in pancreatic pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||15.29|-10.11|
74066336|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||||TWO_SIDED|95.0|-13.39|20.2||||||For change in eating related items at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.20|-13.39|
74066337|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7|||||TWO_SIDED|95.0|5.96|33.43||||||For change in altered bowel habits at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||33.43|5.96|
74066338|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.7|||||TWO_SIDED|95.0|0.93|24.47||||||For change in jaundice at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||24.47|0.93|
74066339|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1|||||TWO_SIDED|95.0|1.28|28.91||||||For change in body image at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||28.91|1.28|
74066340|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|||||TWO_SIDED|95.0|-14.59|23.3||||||For change in health care satisfaction at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||23.30|-14.59|
73883232|NCT03583099|147300534|SUPERIORITY||Difference in proportion|-2.2||||0.62|TWO_SIDED|95.0|-10.9|6.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.5|-10.9|0.62
73883233|NCT03583099|147300535|SUPERIORITY||Difference in proportion|-1.64||||0.84|TWO_SIDED|95.0|-17.27|13.99|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.99|-17.27|0.84
73883234|NCT03583099|147300536|SUPERIORITY||Difference in proportion|6.09||||0.27|TWO_SIDED|95.0|-4.63|16.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.80|-4.63|0.27
74066341|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.19|||||TWO_SIDED|95.0|-37.53|-4.85||||||For change in sexual functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||-4.85|-37.53|
74066342|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.82|||||TWO_SIDED|95.0|-25.04|9.4||||||For change in ascites at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||9.40|-25.04|
74066343|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.95|||||TWO_SIDED|95.0|-9.59|21.5||||||For change in indigestion at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||21.50|-9.59|
74066344|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.39|||||TWO_SIDED|95.0|-1.61|30.4||||||For change in flatulence at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||30.40|-1.61|
74066345|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|||||TWO_SIDED|95.0|2.78|22.22||||||For change in cachexia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.22|2.78|
74066346|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.88|||||TWO_SIDED|95.0|1.36|20.39||||||For change in side effects at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.39|1.36|
74066347|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|||||TWO_SIDED|95.0|-16.36|11.71||||||For change in fear of future health at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||11.71|-16.36|
74066348|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.21|||||TWO_SIDED|95.0|-11.78|24.2||||||For change in ability to plan future at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||24.20|-11.78|
74066349|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.87|||||TWO_SIDED|95.0|0.79|28.94||||||For change in pancreatic pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||28.94|0.79|
74066350|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.49|||||TWO_SIDED|95.0|-7.45|34.42||||||For change in eating related items at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||34.42|-7.45|
74066351|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.86|||||TWO_SIDED|95.0|0.17|37.55||||||For change in altered bowel habits at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||37.55|0.17|
74066352|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.57|||||TWO_SIDED|95.0|0.66|22.48||||||For change in jaundice at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.48|0.66|
74066353|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.72|||||TWO_SIDED|95.0|0.49|36.95||||||For change in body image at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||36.95|0.49|
74066354|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.61|||||TWO_SIDED|95.0|-32.4|11.17||||||For change in health care satisfaction at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||11.17|-32.40|
74066355|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||||TWO_SIDED|95.0|-14.63|17.27||||||For change in sexual functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||17.27|-14.63|
74066356|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54|||||TWO_SIDED|95.0|-14.7|17.78||||||For change in ascites at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||17.78|-14.70|
74066357|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.05|||||TWO_SIDED|95.0|-10.65|32.75||||||For change in indigestion at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||32.75|-10.65|
74066358|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|-17.33|24.13||||||For change in flatulence at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||24.13|-17.33|
74066359|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.27|||||TWO_SIDED|95.0|-4.4|22.93||||||For change in cachexia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.93|-4.40|
74066360|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.19|||||TWO_SIDED|95.0|2.99|35.39||||||For change in side effects at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||35.39|2.99|
74066361|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|||||TWO_SIDED|95.0|-23.7|22.43||||||For change in fear of future health at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.43|-23.70|
74066362|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.51|||||TWO_SIDED|95.0|-3.1|46.12||||||For change in ability to plan future at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||46.12|-3.10|
74066363|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|95.0|-21.57|13.19||||||For change in pancreatic pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||13.19|-21.57|
74066364|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6|||||TWO_SIDED|95.0|-32.86|7.66||||||For change in eating related items at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||7.66|-32.86|
74066365|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.25|||||TWO_SIDED|95.0|-10.33|34.82||||||For change in altered bowel habits at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||34.82|-10.33|
74066366|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.84|||||TWO_SIDED|95.0|-0.18|25.85||||||For change in jaundice at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||25.85|-0.18|
74066367|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.85|||||TWO_SIDED|95.0|-16.45|24.14||||||For change in body image at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.14|-16.45|
74066368|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05|||||TWO_SIDED|95.0|-23.23|37.34||||||For change in health care satisfaction at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||37.34|-23.23|
74066369|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|||||TWO_SIDED|95.0|-26.55|21.5||||||For change in sexual functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||21.50|-26.55|
73883235|NCT03583099|147300537|SUPERIORITY||Difference in proportion|2.91||||0.55|TWO_SIDED|95.0|-6.59|12.41|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.41|-6.59|0.55
73883236|NCT03583099|147300538|SUPERIORITY||Difference in proportion|2.37||||0.69|TWO_SIDED|95.0|-9.09|13.83|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.83|-9.09|0.69
74066370|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.46|||||TWO_SIDED|95.0|-27.48|8.56||||||For change in ascites at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||8.56|-27.48|
74066371|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.96|||||TWO_SIDED|95.0|-30.62|16.7||||||For change in indigestion at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||16.70|-30.62|
74066372|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.71|||||TWO_SIDED|95.0|-20.37|27.8||||||For change in flatulence at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||27.80|-20.37|
74066373|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.04|||||TWO_SIDED|95.0|-5.73|31.81||||||For change in cachexia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||31.81|-5.73|
74066374|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.12|||||TWO_SIDED|95.0|-3.23|33.46||||||For change in side effects at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||33.46|-3.23|
74066375|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|||||TWO_SIDED|95.0|-36.18|20.37||||||For change in fear of future health at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||20.37|-36.18|
74066376|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.38|||||TWO_SIDED|95.0|-20.24|51.01||||||For change in ability to plan future at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||51.01|-20.24|
74066377|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.25|||||TWO_SIDED|95.0|-10.09|32.59||||||For change in pancreatic pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||32.59|-10.09|
74066378|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41|||||TWO_SIDED|95.0|-25.22|40.03||||||For change in eating related items at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||40.03|-25.22|
74066379|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.28|||||TWO_SIDED|95.0|4.23|52.32||||||For change in altered bowel habits at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||52.32|4.23|
74066380|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.22|||||TWO_SIDED|95.0|5.09|43.34||||||For change in jaundice at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||43.34|5.09|
74066381|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.11|||||TWO_SIDED|95.0|-0.16|50.38||||||For change in body image at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||50.38|-0.16|
74066382|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.07|||||TWO_SIDED|95.0|-47.95|27.8||||||For change in health care satisfaction at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||27.80|-47.95|
74066383|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.61|||||TWO_SIDED|95.0|-21.78|14.57||||||For change in sexual functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||14.57|-21.78|
74066384|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.98|||||TWO_SIDED|95.0|-17.02|28.99||||||For change in ascites at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||28.99|-17.02|
74066385|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.08|||||TWO_SIDED|95.0|-5.39|49.55||||||For change in indigestion at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||49.55|-5.39|
74066386|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.78|||||TWO_SIDED|95.0|-15.33|34.89||||||For change in flatulence at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||34.89|-15.33|
74066387|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.81|||||TWO_SIDED|95.0|-10.43|42.06||||||For change in cachexia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.06|-10.43|
74066388|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.77|||||TWO_SIDED|95.0|1.11|42.43||||||For change in side effects at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.43|1.11|
74066389|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.81|||||TWO_SIDED|95.0|-41.91|12.28||||||For change in fear of future health at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||12.28|-41.91|
74066390|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.11|||||TWO_SIDED|95.0|1.6|60.62||||||For change in ability to plan future at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||60.62|1.60|
74066391|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.74|||||TWO_SIDED|95.0|-20.62|38.1||||||For change in pancreatic pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||38.10|-20.62|
74066392|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|||||TWO_SIDED|95.0|-68.52|42.05||||||For change in eating related items at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||42.05|-68.52|
74066393|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.06|||||TWO_SIDED|95.0|-7.93|52.05||||||For change in altered bowel habits at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||52.05|-7.93|
74066394|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.63|||||TWO_SIDED|95.0|-5.64|42.89||||||For change in jaundice at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||42.89|-5.64|
74066395|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.96|||||TWO_SIDED|95.0|-9.93|57.84||||||For change in body image at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||57.84|-9.93|
74066396|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.54|||||TWO_SIDED|95.0|-32.7|59.78||||||For change in health care satisfaction at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.78|-32.70|
74066397|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.14|||||TWO_SIDED|95.0|-29.46|55.74||||||For change in sexual functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||55.74|-29.46|
74066398|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.37|||||TWO_SIDED|95.0|-24.04|36.79||||||For change in ascites at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||36.79|-24.04|
74066399|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.59|||||TWO_SIDED|95.0|-17.94|59.12||||||For change in indigestion at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.12|-17.94|
74066400|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.29|||||TWO_SIDED|95.0|-20.12|40.71||||||For change in flatulence at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||40.71|-20.12|
74066401|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.74|||||TWO_SIDED|95.0|-8.22|59.69||||||For change in cachexia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.69|-8.22|
74066402|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.56|||||TWO_SIDED|95.0|5.32|71.81||||||For change in side effects at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||71.81|5.32|
74066403|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||||TWO_SIDED|95.0|-53.14|44.25||||||For change in fear of future health at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||44.25|-53.14|
74066404|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-69.9|61.57||||||For change in ability to plan future at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||61.57|-69.90|
74066405|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.96|||||TWO_SIDED|95.0|-24.52|50.45||||||For change in pancreatic pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||50.45|-24.52|
73883237|NCT03583099|147300539|SUPERIORITY||Difference in proportion|0.36||||0.93|TWO_SIDED|95.0|-8.13|8.85|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.85|-8.13|0.93
74066406|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.15|||||TWO_SIDED|95.0|-76.41|30.11||||||For change in eating related items at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||30.11|-76.41|
74066407|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.44|||||TWO_SIDED|95.0|-71.89|33.0||||||For change in altered bowel habits at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||33.00|-71.89|
74066408|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.22|||||TWO_SIDED|95.0|7.31|87.13||||||For change in jaundice at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||87.13|7.31|
73883238|NCT03583099|147300540|SUPERIORITY||Difference in proportion|-4.01||||0.26|TWO_SIDED|95.0|-10.97|2.95|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.95|-10.97|0.26
73883239|NCT03583099|147300541|SUPERIORITY||Difference in proportion|-2.04||||0.74|TWO_SIDED|95.0|-14.28|10.21|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.21|-14.28|0.74
74066409|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.67|||||TWO_SIDED|95.0|-36.0|119.34||||||For change in body image at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||119.34|-36.00|
74066410|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-5.05|82.83||||||For change in health care satisfaction at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||82.83|-5.05|
74066411|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.14|||||TWO_SIDED|95.0|-2.09|66.37||||||For change in sexual functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-2.09|
74066412|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|||||TWO_SIDED|95.0|-44.46|29.64||||||For change in indigestion at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||29.64|-44.46|
74066413|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.96|||||TWO_SIDED|95.0|-40.45|66.37||||||For change in flatulence at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-40.45|
74066414|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.89|||||TWO_SIDED|95.0|-32.71|60.49||||||For change in cachexia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||60.49|-32.71|
74066415|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.86|||||TWO_SIDED|95.0|-16.16|77.89||||||For change in side effects at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||77.89|-16.16|
74066416|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-44.95|86.62||||||For change in fear of future health at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||86.62|-44.95|
74066417|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-115.22|78.19||||||For change in ability to plan future at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||78.19|-115.22|
73883240|NCT03583099|147300542|SUPERIORITY||Difference in proportion|0.1||||0.98|TWO_SIDED|95.0|-7.9|8.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.1|-7.9|0.98
74066418|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.46|||||TWO_SIDED|95.0|-39.71|86.63||||||For change in pancreatic pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||86.63|-39.71|
74066419|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.96|||||TWO_SIDED|95.0|-130.69|104.76||||||For change in eating related items at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||104.76|-130.69|
74066420|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.15|||||TWO_SIDED|95.0|-7.12|103.42||||||For change in altered bowel habits at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.42|-7.12|
74066421|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|92.59|||||TWO_SIDED|95.0|63.16|122.02||||||For change in jaundice at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||122.02|63.16|
74066422|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-85.03|96.14||||||For change in body image at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.14|-85.03|
74066423|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.04|||||TWO_SIDED|95.0|-29.46|103.54||||||For change in health care satisfaction at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.54|-29.46|
74066424|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.14|||||TWO_SIDED|95.0|-41.45|27.16||||||For change in sexual functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||27.16|-41.45|
74066425|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-67.04|59.64||||||For change in ascites at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||59.64|-67.04|
74066426|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|||||TWO_SIDED|95.0|-104.79|89.97||||||For change in indigestion at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||89.97|-104.79|
74066427|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.22|||||TWO_SIDED|95.0|-58.8|103.25||||||For change in flatulence at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.25|-58.80|
74066428|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-36.28|91.83||||||For change in cachexia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||91.83|-36.28|
74066429|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-74.3|96.52||||||For change in side effects at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.52|-74.30|
74066430|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.17|||||TWO_SIDED|95.0|-142.55|84.21||||||For change in fear of future health at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||84.21|-142.55|
74066431|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.56|||||TWO_SIDED|95.0|-212.46|101.35||||||For change in ability to plan future at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||101.35|-212.46|
74066432|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-62.93|96.26||||||For change in pancreatic pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||96.26|-62.93|
74066433|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.29|||||TWO_SIDED|95.0|-87.74|116.31||||||For change in eating related items at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||116.31|-87.74|
74066434|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.81|||||TWO_SIDED|95.0|7.9|139.72||||||For change in altered bowel habits at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||139.72|7.90|
74066435|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.19|||||TWO_SIDED|95.0|33.64|118.74||||||For change in jaundice at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||118.74|33.64|
74066436|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||||TWO_SIDED|95.0|-64.64|121.79||||||For change in body image at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||121.79|-64.64|
74066437|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.71|||||TWO_SIDED|95.0|-28.11|99.53||||||For change in health care satisfaction at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||99.53|-28.11|
74066438|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.33|||||TWO_SIDED|95.0|-104.01|77.34||||||For change in sexual functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||77.34|-104.01|
74066439|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.44|||||TWO_SIDED|95.0|-140.03|51.14||||||For change in ascites at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||51.14|-140.03|
74066440|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.76|||||TWO_SIDED|95.0|-88.45|97.98||||||For change in indigestion at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||97.98|-88.45|
74066441|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.29|||||TWO_SIDED|95.0|-54.32|82.89||||||For change in flatulence at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||82.89|-54.32|
74066442|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.81|||||TWO_SIDED|95.0|-66.45|114.07||||||For change in cachexia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||114.07|-66.45|
74066443|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.75|||||TWO_SIDED|95.0|-56.14|119.63||||||For change in side effects at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||119.63|-56.14|
74066444|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.0|||||TWO_SIDED|95.0|-163.35|63.35||||||For change in fear of future health at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||63.35|-163.35|
74066445|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.29|||||TWO_SIDED|95.0|-125.23|96.66||||||For change in ability to plan future at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||96.66|-125.23|
74066446|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-45.18|95.18||||||For change in pancreatic pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||95.18|-45.18|
74066447|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-45.18|95.18||||||For change in eating related items at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||95.18|-45.18|
74066448|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.78|||||TWO_SIDED|95.0|14.55|141.0||||||For change in altered bowel habits at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||141.00|14.55|
74066449|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.11|||||TWO_SIDED|95.0|40.61|131.61||||||For change in jaundice at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||131.61|40.61|
74066450|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-56.48|106.48||||||For change in body image at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||106.48|-56.48|
74066451|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.22|||||TWO_SIDED|95.0|-37.69|132.13||||||For change in health care satisfaction at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||132.13|-37.69|
74066452|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|||||TWO_SIDED|95.0|-70.68|110.68||||||For change in sexual functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.68|-70.68|
74066453|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.33|||||TWO_SIDED|95.0|-91.87|25.2||||||For change in ascites at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||25.20|-91.87|
74066454|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-41.89|97.45||||||For change in indigestion at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||97.45|-41.89|
74066455|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-34.03|67.36||||||For change in flatulence at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||67.36|-34.03|
74066456|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-100.19|116.86||||||For change in cachexia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||116.86|-100.19|
74066457|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.93|||||TWO_SIDED|95.0|-53.73|105.58||||||For change in side effects at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||105.58|-53.73|
74066458|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-117.07|117.07||||||For change in ability to plan future at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||117.07|-117.07|
74066459|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.89|||||TWO_SIDED|95.0|-221.53|249.31||||||For change in pancreatic pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||249.31|-221.53|
73883241|NCT03583099|147300543|SUPERIORITY||Difference in proportion|2.6||||0.46|TWO_SIDED|95.0|-4.3|9.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.6|-4.3|0.46
74066460|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-260.62|271.74||||||For change in eating related items at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||271.74|-260.62|
74066461|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.67|||||TWO_SIDED|95.0|-152.41|285.75||||||For change in altered bowel habits at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||285.75|-152.41|
74066462|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|||||TWO_SIDED|95.0|-119.08|319.08||||||For change in jaundice at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||319.08|-119.08|
74066463|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-185.75|252.41||||||For change in body image at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||252.41|-185.75|
74066464|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-82.04|170.93||||||For change in health care satisfaction at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||170.93|-82.04|
74066465|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in sexual functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
74066466|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-202.34|180.12||||||For change in ascites at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||180.12|-202.34|
74066467|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-84.5|106.73||||||For change in indigestion at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||106.73|-84.50|
74066468|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-84.5|106.73||||||For change in flatulence at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||106.73|-84.50|
74066469|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-87.6|165.37||||||For change in cachexia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||165.37|-87.60|
74066470|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-208.53|297.42||||||For change in side effects at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||297.42|-208.53|
74066471|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.22|||||TWO_SIDED|95.0|-275.19|230.75||||||For change in ability to plan future at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||230.75|-275.19|
74066472|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.33|||||TWO_SIDED|95.0|-491.86|608.53||||||For change in pancreatic pain at EoS, mean change difference was used to compare the two treatment groups.||608.53|-491.86|
74066473|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-1258.79|1308.79||||||For change in eating related items at EoS, mean change difference was used to compare the two treatment groups.||1308.79|-1258.79|
74066474|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in altered bowel habits at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
74066475|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-175.06|191.73||||||For change in jaundice at EoS, mean change difference was used to compare the two treatment groups.||191.73|-175.06|
74066476|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in ascites at EoS, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
74066477|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in indigestion at EoS, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
74066478|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in flatulence at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
74066479|NCT00219557|147685241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.56|||||TWO_SIDED|95.0|-1375.5|1436.61||||||For change in side effects at EoS, mean change difference was used to compare the two treatment groups.||1436.61|-1375.5|
74066480|NCT02345486|147685259|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.001|TWO_SIDED|95.0|0.66|0.74|||Wilcoxon (Mann-Whitney)||"reported mean difference is a difference in proportions."|||0.74|0.66|0.001
74066481|NCT02741271|147685288|SUPERIORITY||LSM Difference|5.21|||<|0.001|TWO_SIDED|95.0|3.21|7.2|||cLDA with multiple imputation|Primary Analysis Method, using the constrained Longitudinal Data Analysis (cLDA) model for missing data|Between-Treatment Difference|||7.20|3.21|<0.001
74066482|NCT02741271|147685291|SUPERIORITY||LSM Difference|6.05|||<|0.001|TWO_SIDED|95.0|3.53|8.56|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 4 hr Post-Dose|||8.56|3.53|<0.001
74066483|NCT02741271|147685291|SUPERIORITY||LSM Difference|7.04|||<|0.001|TWO_SIDED|95.0|4.74|9.35|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 2 hr Post-Dose|||9.35|4.74|<0.001
74066484|NCT02741271|147685291|SUPERIORITY||LSM Difference|6.19|||<|0.001|TWO_SIDED|95.0|4.09|8.28|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 60 min Post-Dose|||8.28|4.09|<0.001
74066485|NCT02741271|147685291|SUPERIORITY||LSM Difference|6.89|||<|0.001|TWO_SIDED|95.0|5.1|8.67|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 30 min Post-Dose|||8.67|5.10|<0.001
74066486|NCT02741271|147685291|SUPERIORITY||LSM Difference|6.64|||<|0.001|TWO_SIDED|95.0|4.89|8.39|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 15 min Post-Dose|||8.39|4.89|<0.001
74066487|NCT02741271|147685291|SUPERIORITY||LSM Difference|4.2|||<|0.001|TWO_SIDED|95.0|2.5|5.91|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 5 min Post-Dose|||5.91|2.50|<0.001
74066488|NCT02741271|147685292|SUPERIORITY||LSM Difference|6.32|||<|0.001|TWO_SIDED|95.0|4.36|8.27|||cLDA|Secondary Outcome Measure on Day 1|Between-Treatment Difference at 4 hr Post-Dose|||8.27|4.36|<0.001
74066489|NCT02741271|147685292|SUPERIORITY||LSM Difference|3.33||||0.026|TWO_SIDED|95.0|0.41|6.26|||cLDA|Secondary Outcome Measure at Week 12|Between-Treatment Difference at 4 hr Post-Dose|||6.26|0.41|0.026
74066490|NCT02741271|147685293|SUPERIORITY||LSM Difference|1.63||||0.197|TWO_SIDED|95.0|-0.85|4.11|||cLDA|Secondary Outcome Measure|Between-Treatment Difference|||4.11|-0.85|0.197
74066491|NCT00410410|147685309|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.124|TWO_SIDED|95.0|0.48|1.09||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata (whether a participant had an inadequate response and/or intolerance to anti-TNF therapy).|Cochran-Mantel-Haenszel|Conditional on ABA 30/\~10 mg/kg vs PLA comparison being statistically significant at 5% level, ABA \~10 vs PLA to be tested at 5% significance level.||Null hypothesis=no treatment difference between ABA arm and placebo (PLA) arm. ABA 30/\~10 mg/kg vs PLA: power=98%, sample size=140 per arm,expected PLA response rate=40%, ABA 30/\~10 mg/kg=65%. ABA \~10 mg/kg vs. PLA: power=90%, sample size=140 per arm, 5% significance; expected PLA response rate= 40%, ABA \~10=60%.||1.09|0.48|0.124
74066492|NCT00410410|147685311|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.06|0.67||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata.|Cochran-Mantel-Haenszel|Conditional on ABA 30/\~10 vs PLA comparison for clinical response being significant at 5% level, this comparison for remission will be tested at 5%.|Conditional on both the remission comparison for ABA 30/\~10 vs PLA, and the clinical response comparison for ABA\~10 vs PLA being significant at 5%, the secondary remission comparison for ABA \~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference between each of the ABA and placebo (PLA). At 5% significance level, Aba 30/\~10 vs. PLA: power=96%, sample size=140 per arm, expected PLA rate=15%. ABA 30/\~10 =35%; Aba \~10 vs. PLA: power=82%, sample size=140 per arm, expected PLA response rate= 15%, ABA/\~10 mg/kg=30%||0.67|.06|
74066493|NCT00410410|147685312|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.42|1.05||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata.|Cochran-Mantel-Haenszel|If ABA 30/\~10 vs PLA remission comparison is significant at 5% level, the mucosal healing comparison for the same treatment group will be tested at 5%|Conditional on both the comparison for mucosal healing for ABA 30/\~10 vs PLA and the comparison for remission for ABA \~10 vs. PLA being significant, the comparison for mucosal healing for ABA \~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1) for mucosal healing. ABA 30/\~10 vs. placebo: power=99%, sample size=140 per arm, expected PLA response rate=30%, ABA 30/\~10 mg/kg=60%. ABA \~10 vs. placebo: power=98%, sample size=140 per arm, 5% significance; expected PLA response rate= 30%, ABA \~10 mg/kg=55%||1.05|0.42|
74066494|NCT00410410|147685313|SUPERIORITY_OR_OTHER|||||||0.044||||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms.||||0.044
74066495|NCT00410410|147685319|SUPERIORITY_OR_OTHER|||||||0.149||||||All statistical testing was performed at a pre-specified alpha-level of 5%|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.149
74066496|NCT02868281|147685398|OTHER||Odds Ratio (OR)|7.87||||0.027|TWO_SIDED|95.0|1.29|48.11|||Mixed effect logistic regression||The model included treatment, Baseline ACT total score, Baseline ACT total score squared, center, type of Baseline controller, gender and age, with the center as a random factor.|||48.11|1.29|0.027
73883242|NCT03583099|147300544|SUPERIORITY||Difference in proportion|1.5||||0.5|TWO_SIDED|95.0|-3.0|6.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.1|-3.0|0.50
73883243|NCT03583099|147300545|SUPERIORITY||Difference in proportion|-0.2||||0.96|TWO_SIDED|95.0|-6.8|6.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.5|-6.8|0.96
73883244|NCT03583099|147300546|SUPERIORITY||Difference in proportion|2.2||||0.4|TWO_SIDED|95.0|-3.0|7.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.5|-3.0|0.40
74066497|NCT02868281|147685399|OTHER||Difference in Least Squares Mean|-0.1||||0.222|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.222
74066498|NCT02868281|147685399|OTHER||Difference in Least Squares Mean|-0.1||||0.156|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.156
74066499|NCT02868281|147685399|OTHER||Difference in Least Squares Mean|-0.1||||0.245|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.245
74066500|NCT02868281|147685399|OTHER||Difference in Least Squares Mean|-0.1||||0.057|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.057
74066501|NCT02868281|147685399|OTHER||Difference in Least Squares Mean|-0.1||||0.151|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.151
74066502|NCT02868281|147685399|OTHER||Difference in Least Squares Mean|-0.1||||0.114|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.114
74066503|NCT02868281|147685400|OTHER||Difference in Least Squares Mean|-0.05||||0.487|TWO_SIDED|95.0|-0.18|0.09|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.09|-0.18|0.487
74066504|NCT02868281|147685400|OTHER||Difference in Least Squares Mean|-0.04||||0.546|TWO_SIDED|95.0|-0.16|0.09|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.09|-0.16|0.546
74066505|NCT02868281|147685400|OTHER||Difference in Least Squares Mean|-0.06||||0.314|TWO_SIDED|95.0|-0.17|0.06|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.06|-0.17|0.314
74066506|NCT02868281|147685400|OTHER||Difference in Least Squares Mean|-0.07||||0.197|TWO_SIDED|95.0|-0.19|0.04|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.04|-0.19|0.197
74066507|NCT02868281|147685400|OTHER||Difference in Least Squares Mean|-0.06||||0.282|TWO_SIDED|95.0|-0.17|0.06|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.06|-0.17|0.282
74066508|NCT02868281|147685400|OTHER||Difference in Least Squares Mean|-0.03||||0.543|TWO_SIDED|95.0|-0.15|0.08|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.08|-0.15|0.543
74066509|NCT02868281|147685401|OTHER||Difference in Least Squares Mean|0.06||||0.273|TWO_SIDED|95.0|-0.059|0.18|||Mixed Model Repeat Measures||The model included covariates of treatment, center, Baseline FEV1, type of Baseline controller, gender and age, with the center as a random factor.|||0.180|-0.059|0.273
74066510|NCT02868281|147685402|OTHER||Difference in Least Squares Mean|-12.0||||0.367|TWO_SIDED|95.0|-40.3|16.3|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||16.3|-40.3|0.367
74066511|NCT02868281|147685402|OTHER||Difference in Least Squares Mean|-7.2||||0.587|TWO_SIDED|95.0|-35.5|21.2|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||21.2|-35.5|0.587
74066512|NCT02868281|147685402|OTHER||Difference in Least Squares Mean|-4.7||||0.721|TWO_SIDED|95.0|-33.1|23.7|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||23.7|-33.1|0.721
74066513|NCT02868281|147685402|OTHER||Difference in Least Squares Mean|-3.3||||0.801|TWO_SIDED|95.0|-31.7|25.1|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.1|-31.7|0.801
74066514|NCT02868281|147685402|OTHER||Difference in Least Squares Mean|-5.0||||0.704|TWO_SIDED|95.0|-33.3|23.4|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||23.4|-33.3|0.704
73883245|NCT03583099|147300547|SUPERIORITY||Difference in proportion|-0.1||||0.96|TWO_SIDED|95.0|-4.3|4.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.0|-4.3|0.96
73883246|NCT03583099|147300548|SUPERIORITY||Difference in proportion|0.1||||0.98|TWO_SIDED|95.0|-7.9|8.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.1|-7.9|0.98
74066515|NCT02868281|147685402|OTHER||Difference in Least Squares Mean|-4.0||||0.762|TWO_SIDED|95.0|-32.4|24.5|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||24.5|-32.4|0.762
74066516|NCT02868281|147685403|OTHER||Difference in Least Squares Mean|-12.8||||0.354|TWO_SIDED|95.0|-42.1|16.5|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||16.5|-42.1|0.354
74066517|NCT02868281|147685403|OTHER||Difference in Least Squares Mean|-8.4||||0.538|TWO_SIDED|95.0|-37.8|21.0|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||21.0|-37.8|0.538
74066518|NCT02868281|147685403|OTHER||Difference in Least Squares Mean|-5.0||||0.716|TWO_SIDED|95.0|-34.4|24.5|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||24.5|-34.4|0.716
74066519|NCT02868281|147685403|OTHER||Difference in Least Squares Mean|-3.1||||0.822|TWO_SIDED|95.0|-32.5|26.3|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||26.3|-32.5|0.822
74066520|NCT02868281|147685403|OTHER||Difference in Least Squares Mean|-4.0||||0.767|TWO_SIDED|95.0|-33.4|25.4|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.4|-33.4|0.767
74066521|NCT02868281|147685403|OTHER||Difference in Least Squares Mean|-3.8||||0.779|TWO_SIDED|95.0|-33.4|25.7|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.7|-33.4|0.779
74066522|NCT02868281|147685404|OTHER||Difference in Least Squares Mean|0.3||||0.059|TWO_SIDED|95.0|0.0|0.6|||Mixed Model Repeat Measures||The model included covariates of treatment, center, Baseline AQLQ(S) score, type of Baseline controller, gender and age, with the center as a random factor.|||0.6|-0.0|0.059
74066523|NCT02868281|147685405|OTHER||Hazard Ratio (HR)|1.843||||0.01|TWO_SIDED|95.0|1.16|2.926|||Cox proportional hazards model||The model included treatment, Baseline ACT total score, center, type of Baseline controller, gender and age as covariates.|||2.926|1.160|0.010
73883247|NCT03583099|147300549|SUPERIORITY||Difference in proportion|-4.2||||0.46|TWO_SIDED|95.0|-15.2|6.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.8|-15.2|0.46
74066524|NCT02868281|147685406|OTHER||Rate Ratio|1.09||||0.897|TWO_SIDED|95.0|0.32|3.73|||Generalised linear model||The model included treatment, Baseline ACT total score, type of Baseline controller, gender and age as covariates.|||3.73|0.32|0.897
74066525|NCT00947765|147685423|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74066526|NCT00947765|147685424|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74066527|NCT00947765|147685425|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0022
74066528|NCT00947765|147685426|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
73883248|NCT03583099|147300550|SUPERIORITY||Difference in proportion|3.9||||0.37|TWO_SIDED|95.0|-4.7|12.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.4|-4.7|0.37
73883249|NCT03583099|147300551|SUPERIORITY||Difference in proportion|-0.8||||0.75|TWO_SIDED|95.0|-6.0|4.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.4|-6.0|0.75
73883250|NCT03583099|147300552|SUPERIORITY||Difference in proportion|-8.7||||0.08|TWO_SIDED|95.0|-18.3|0.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.9|-18.3|0.08
74066529|NCT00947765|147685427|SUPERIORITY_OR_OTHER|||||||0.0127||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0127
74066530|NCT00947765|147685428|SUPERIORITY_OR_OTHER|||||||0.0184||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0184
74066531|NCT00947765|147685429|SUPERIORITY_OR_OTHER|||||||0.0058||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0058
74066532|NCT00947765|147685430|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0064
74066533|NCT00433381|147685473|OTHER|||||||||||||||||Null hypothesis: 20% of patients progression-free at six months. Alternative hypothesis: 35%. Type I and II error rates = 0.10. Required sample size = 57.|The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.|||
74066534|NCT00433381|147685474|OTHER|||||||||||||||||Null hypothesis: 35% discontinuation rate of bevacizumab and temozolomide. Alternative hypothesis: 5%. Type I and II error rates = 0.10. Sample size = 29.|The determination of treatment tolerability was to be made based on the following rules: If 6 or fewer of the cases (6/29=20.6%) stop treatment due to medical conditions, then reject the null hypothesis that the discontinuation rate is at least 35% and conclude tolerability. If 7 or more of the cases (7/29=24.1%) stop treatment due to medical conditions, then reject the alternative hypothesis that the discontinuation rate no more than 15%.|||
74066535|NCT00433381|147685475|OTHER|Receiver Operating Characteristic (ROC) analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.09|0.91||||||Accuracy estimate, as measured by the Area under the Curve (AUC), for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 2 weeks||0.91|0.09|
74066536|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|0.54|||||TWO_SIDED|95.0|0.14|0.95||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 2 weeks||0.95|0.14|
74066537|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|0.46|||||TWO_SIDED|95.0|0.0|0.99||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 2 weeks||0.99|0|
74066538|NCT00433381|147685475|OTHER||Area Under the Curve (AUC)|0.85|||||TWO_SIDED|95.0|0.53|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 8 weeks||1|0.53|
74066539|NCT00433381|147685475|OTHER||Area Under the Curve (AUC)|0.83|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 8 weeks||1|0.47|
74066540|NCT00433381|147685475|OTHER||Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.11|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 8 weeks||1|0.11|
74066541|NCT00433381|147685475|OTHER||Area Under the Curve (AUC)|0.75|||||TWO_SIDED|95.0|0.21|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 16 weeks||1|0.21|
74066542|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 16 weeks||1|1|
74066543|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|0.46|||||TWO_SIDED|95.0|0.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 16 weeks||1|0|
74066544|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|0.39|||||TWO_SIDED|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 2 weeks||0.88|0|
74066545|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|0.52|||||TWO_SIDED|95.0|0.13|0.91||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 2 weeks||0.91|0.13|
74066546|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|0.54|||||TWO_SIDED|95.0|0.06|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 2 weeks||1|0.06|
74066547|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|0.47|||||TWO_SIDED|95.0|0.02|0.92||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 8 weeks||0.92|0.02|
74066548|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|0.41|||||TWO_SIDED|95.0|0.01|0.8||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 8 weeks||0.80|0.01|
74066549|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|0.63|||||TWO_SIDED|95.0|0.22|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 8 weeks||1|0.22|
74066550|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 16 weeks||1|1|
74066551|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 16 weeks||1|1|
74066552|NCT00433381|147685475|OTHER|ROC analysis|Area Under the Curve (AUC)|0.93|||||TWO_SIDED|95.0|0.73|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 16 weeks||1|0.73|
74066553|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.42|||||TWO_SIDED|95.0|0.0|0.92||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 2 weeks||0.92|0|
74066554|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.42|||||TWO_SIDED|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 2 weeks||0.88|0|
74066555|NCT00433381|147685476|OTHER|ROC analysis|Accuracy: Area Under the ROC|0.67|||||TWO_SIDED|95.0|0.25|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 2 weeks||1|0.25|
74066556|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 8 weeks||1|0.47|
74066557|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.78|||||TWO_SIDED|95.0|0.44|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 8 weeks||1|0.44|
74066558|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.17|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 8 weeks||1|0.17|
74066559|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.45|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 16 weeks||1|0.45|
74066560|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.73|||||TWO_SIDED|95.0|0.19|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 16 weeks||1|0.19|
74066561|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.57|||||TWO_SIDED|95.0|0.03|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 16 weeks||1|0.03|
74066562|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.2|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 2 weeks||1|0.20|
74066563|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.36|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 2 weeks||1|0.36|
74066564|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.06|0.94||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 2 weeks||0.94|0.06|
74066565|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.58|||||TWO_SIDED|95.0|0.22|0.95||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 8 weeks||0.95|0.22|
74066566|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.13|0.87||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 8 weeks||0.87|0.13|
74066567|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.78|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 8 weeks||1|0.47|
74066568|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 16 weeks||1|1|
74066569|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.63|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 16 weeks||1|0.63|
74066570|NCT00433381|147685476|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 16 weeks||1|1|
74066571|NCT00433381|147685477|OTHER||||||||||||||||||The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.|||
74066572|NCT00433381|147685479|OTHER|Agreement was assessed using a Kappa statistic|Kappa Statistic|0.39|||||TWO_SIDED|95.0|0.21|0.57||||||Agreement between Local and Central determinations 6-month PFS, based on imaging, was evaluated using Kappa statistics||0.57|0.21|
74066573|NCT00433381|147685480|OTHER|Sensitivity|Sensitivity|0.6|||||TWO_SIDED|95.0|0.46|0.73||||||Sensitivity||0.73|0.46|
74066574|NCT00433381|147685480|OTHER|Specificity|Specificity|0.78|||||TWO_SIDED|95.0|0.66|0.87||||||Specificity||0.87|0.66|
74066575|NCT00325403|147685498|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|23.0||||0.0125|TWO_SIDED|95.0|4.0|41.0||P-Value|ANCOVA|||Using an allocation ratio of 2:1 between oral treprostinil and placebo, a fixed sample size of approximately 195 subjects with access to 0.25 mg tablets at randomization would provide at least 90% power at a significance level of 0.01 (two-sided hypothesis) to detect a between-treatment difference in the change from Baseline to Week 12 in distance traversed during the 6-minute walk, assuming a true underlying treatment difference of 45 meters with a SD of 75 meters in both treatment groups.||41|4|0.0125
74066576|NCT00325403|147685499|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|13.0||||0.0653|TWO_SIDED|95.0|-2.0|33.0|||ANCOVA|||||33|-2|0.0653
74066577|NCT00325403|147685500|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|17.0||||0.0307|TWO_SIDED|95.0|1.0|33.0|||ANCOVA|||||33|1|0.0307
74066578|NCT00325403|147685501|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|12.0||||0.0518|TWO_SIDED|95.0|0.0|24.0|||ANCOVA|||||24|0|0.0518
74066579|NCT00325403|147685502|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.000
74066580|NCT00325403|147685503|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.738|TWO_SIDED|95.0|0.0|0.0||"In cases where the value corresponding to overall poorest relative change was imputed for walk distance, a value of IV was used for the WHO functional classification for PAH."|Wilcoxon rank sum test||The values for the estimated parameter and 95% confidence interval were calculated.|||0|0|0.7380
74066581|NCT00325403|147685504|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.4887|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||||0|-1|0.4887
74066582|NCT00325403|147685505|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.6116|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon sum-rank test|||||1|0|0.6116
74066583|NCT00325403|147685507|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|26.0||||0.0326|TWO_SIDED|95.0|1.0|49.0|||ANCOVA|||||49|1|0.0326
74066584|NCT00325403|147685508|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|16.0||||0.2275|TWO_SIDED|95.0|-15.0|47.0|||ANCOVA|||||47|-15|0.2275
74066585|NCT00325403|147685509|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|32.0||||0.0024|TWO_SIDED|95.0|10.0|55.0|||ANCOVA|||||55|10|0.0024
74066586|NCT00325403|147685510|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|25.5||||0.0001|TWO_SIDED|95.0|10.0|41.0|||ANCOVA|||||41|10|0.0001
74066587|NCT00325403|147685511|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|17.0||||0.0025|TWO_SIDED|95.0|3.0|33.0|||ANCOVA|||||33|3|0.0025
74066588|NCT00325403|147685512|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|20.0||||0.0008|TWO_SIDED|95.0|7.0|34.0|||ANCOVA|||||34|7|0.0008
74066589|NCT00325403|147685513|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|14.0||||0.0025|TWO_SIDED|95.0|3.9|25.0|||ANCOVA|||||25|3.9|0.0025
74066590|NCT00936884|147685524|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|83.6|||<|0.0001|TWO_SIDED|97.5|6.5|1074.7||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after the first injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared|||||1074.7|6.50|<0.0001
74066591|NCT00936884|147685525|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|56.64|||<|0.0001|TWO_SIDED|97.5|40.62|72.66||Comparison of the MNTX group and the placebo group was based on ANOVA model with the proportion of injections resulting in RFBM within 4 hours during the double-blind period as the dependent variable and the treatment group as the fixed effect. .|ANOVA||Estimated value is the difference in least squared means for MNTX vs. placebo (MNTX minus placebo). Based on the ANOVA model, there is 97.5% confidence that the difference between MNTX and placebo falls between the lower and upper limits presented.|||72.66|40.62|<0.0001
74066592|NCT00936884|147685526|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|23.38|||<|0.0001|TWO_SIDED|97.5|10.91|50.14||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after each injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared|||||50.14|10.91|< 0.0001
74066593|NCT02967133|147685538|SUPERIORITY|||||||0.5186|||||||Log Rank|||||||0.5186
74066594|NCT01034137|147685539|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.996|||<|0.001|TWO_SIDED|95.0|1.589|2.506|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the Cochran-Mantel-Haenszel (CMH) test taking into account the stratification factors used for randomization.||2.506|1.589|< 0.001
74066595|NCT01034137|147685539|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.855|||<|0.001|TWO_SIDED|95.0|1.481|2.323|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.||2.323|1.481|< 0.001
74066596|NCT01034137|147685539|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.616|TWO_SIDED|95.0|0.915|1.16|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.||1.160|0.915|0.616
74066597|NCT01764854|147685581|SUPERIORITY|||||||0.46|||||||ANCOVA|||AZD1722 in-patient and Placebo in-patient are not included in this analysis since it was only a one week evaluation period and an effect was not expected. Also the size (n=8) of the group was too small to .perform this analysis.||||0.46
74066598|NCT01764854|147685582|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||AZD1722 out-patient and Placebo out-patient were not included in this analysis since stool was only collected in the clinical pharmacology unit of the in-patient groups.||||<0.0001
74066599|NCT00936377|147685583|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
74066600|NCT00936377|147685583|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
74066601|NCT00936377|147685584|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
74066602|NCT00936377|147685584|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
74066603|NCT00936377|147685585|SUPERIORITY_OR_OTHER|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
74066604|NCT00936377|147685585|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
74066605|NCT00936377|147685586|SUPERIORITY_OR_OTHER|||||||0.18||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected|||Percentage of CIWA scores rates as severe||||0.18
74066606|NCT00936377|147685586|SUPERIORITY_OR_OTHER|||||||0.35||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected|||||||0.35
74066607|NCT00936377|147685587|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||For hypotension||||1
74066608|NCT00936377|147685587|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||For hypotension||||0.47
74066609|NCT00936377|147685587|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||For bradycardia||||1
74066610|NCT00936377|147685587|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||For bradycardia||||0.2
74066611|NCT00936377|147685588|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Repeated measures ANOVA|||||||<0.05
74066612|NCT00936377|147685589|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
74066613|NCT00936377|147685589|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
74066614|NCT00936377|147685590|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
74066615|NCT00936377|147685590|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
74066616|NCT00472446|147685614|SUPERIORITY_OR_OTHER|||||||0.028|||||||t-test, 2 sided|||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)||||.028
74066617|NCT00472446|147685615|SUPERIORITY_OR_OTHER|||||||0.016|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)||||0.016
74066618|NCT00472446|147685615|SUPERIORITY_OR_OTHER|||||||0.723|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure pre-operative versus post-operative application||||0.723
74066619|NCT00472446|147685617|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Fisher Exact|mid p value of the two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Paracetamol:"||||0.94
74066620|NCT00472446|147685617|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Fisher Exact|mid p value of two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Metamizole:"||||0.58
74066621|NCT00472446|147685618|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: paracetamol"||||0.328
74066622|NCT00472446|147685618|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: metamizole"||||0.81
74066623|NCT00472446|147685618|SUPERIORITY_OR_OTHER|||||||0.331|TWO_SIDED||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled paracetamol dose"||||0.331
74066624|NCT00472446|147685618|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled metamizole dose"||||0.440
74066625|NCT00472446|147685619|SUPERIORITY_OR_OTHER|||||||0.925|TWO_SIDED||||||non-parametric ANOVA-type statistic|non-parametric ANOVA-type statistic for pooled main effects, full model||null hypothesis: no difference in outcome measure for superficial cervical block versus placebo treatment||||0.925
74066626|NCT01275313|147685639|EQUIVALENCE|Power calculation: To determine a difference of 20% in the control group and 10% in the treatment group with 80% power, 440 participants would be needed.||||||0.77|||||||Chi-squared, Corrected|||Null hypothesis: At-risk nursing home residents provided with an individually-configured manual lightweight wheelchair and skin protection cushion have the same incidence of pressure injury development compared to individuals using a facility-provided manual wheelchair modified with a skin protection cushion and related adjustments.||||0.77
74066627|NCT01165684|147685640|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently if the p-value for the one-sided test of was less than or equal to 2.5%, where D is the mean treatment difference (step-wise regimen minus basal-bolus regimen).|Estimated treatment difference, Mean|0.14||||0.088||95.0|-0.02|0.3|||Regression, Linear|||||0.30|-0.02|0.088
74066628|NCT01165684|147685641|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.55|||<|0.001||95.0|0.42|0.69|||Regression, Linear|||||0.69|0.42|<0.001
74066629|NCT01165684|147685642|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.37|||<|0.001||95.0|0.21|0.53|||Regression, Linear|||||0.53|0.21|<0.001
74066630|NCT01165684|147685643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.85|||<|0.001||95.0|4.12|11.39|||Regression, Logistic|||||11.39|4.12|<0.001
74066631|NCT01165684|147685644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38|||<|0.001||95.0|1.56|3.64|||Regression, Logistic|||||3.64|1.56|<0.001
74066632|NCT01165684|147685645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.146||95.0|0.9|2.07|||Regression, Logistic|||||2.07|0.90|0.146
74066633|NCT01165684|147685648|SUPERIORITY_OR_OTHER||Estimated Mean|0.12||||0.635||95.0|-0.37|0.6|||Regression, Linear|||||0.60|-0.37|0.635
74066634|NCT01165684|147685651|SUPERIORITY_OR_OTHER||Estimated mean|0.36||||0.046||95.0|0.01|0.71|||Regression, Linear|||||0.71|0.01|0.046
74066635|NCT01165684|147685652|SUPERIORITY_OR_OTHER||Estimated mean|-0.48||||0.228||95.0|-1.25|0.3|||Regression, Linear|||||0.30|-1.25|0.228
74066636|NCT01165684|147685653|SUPERIORITY_OR_OTHER||Estimated mean|-0.17||||0.224||95.0|-0.45|0.11|||Regression, Linear|||||0.11|-0.45|0.224
74066637|NCT02462421|147685672|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||No adjustment for multiple comparisons. Viewed as unnecessary inasmuch as none of the comparisons achieved p\<0.05.|t-test, 2 sided|||"Each of the variant genotypes was compared to the control group (homozygous for major alleles at all three genetic loci) in an unpaired t-test. The study was terminated early because it was clear that we would not meet our recruitment targets and that the study was likely underpowered.~Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant."||||0.92
74066638|NCT02462421|147685672|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.63||||||Not corrected for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.63
74066639|NCT02462421|147685672|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.86||||||Not adjusted for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.86
74066640|NCT02462421|147685673|OTHER|"We compared the two groups (wild type versus SLC2A9 variant homozygotes. Null hypothesis: there are no differences between the two groups with respect to the pharmacodynamic effect of canagliflozin on fractional excretion of uric acid in the urine."||||||0.04||||||Because the study was terminated early, we did not have sufficient statistical power to adjust for multiple comparisons. We are reporting a nominal p-value without adjusting for multiple comparisons|t-test, 2 sided|||The study was terminated early because of slow recruitment. As a result the study did not achieve the statistical power that had been planned.||||0.04
74066641|NCT02462421|147685674|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.07||||||Not corrected for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.07
74066642|NCT02462421|147685674|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.53||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.53
74066643|NCT02462421|147685674|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.92
74066644|NCT02462421|147685675|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.|||||<|0.01||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||<0.01
74066645|NCT02462421|147685675|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.77||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.77
74066646|NCT02462421|147685675|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.65||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.65
74066647|NCT02462421|147685676|OTHER|Null hypothesis: None of the three genotypes is associated with an alteration in the pharmacodynamic effect of canagliflozin on urinary Na excretion||||||0.2||||||Because the study was terminated early, the study does not have sufficient statistical power to adjust for multiple comparisons. Accordingly, nominal p-values are reported.|t-test, 2 sided|||"The wild type genotype group was compared to homozygotes for each of the three other genotypes."||||0.20
74066648|NCT02462421|147685676|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.01|||||||t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.01
74066649|NCT02462421|147685676|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.16||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.16
74066650|NCT02462421|147685677|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.21||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.21
74066651|NCT02462421|147685677|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.92
74066652|NCT02462421|147685677|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.39||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Not corrected for multiple comparisons.||||0.39
73883251|NCT03583099|147300553|SUPERIORITY||Difference in proportion|-4.8||||0.11|TWO_SIDED|95.0|-10.6|1.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.1|-10.6|0.11
74066653|NCT01339910|147685701|SUPERIORITY||Difference in 18 month OS (MAC-RIC)|9.8||||0.07|TWO_SIDED|95.0|-0.8|20.3||This final test was performed at a 0.049 significance level, since 0.001 was spent at interim analyses and the overall significance level was 0.050.|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in overall survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month overall survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.||20.3|-0.8|0.07
74066654|NCT01339910|147685702|SUPERIORITY||Difference in 18 month RFS (MAC-RIC)|20.4|||<|0.01|TWO_SIDED|95.0|8.9|32.0||Test performed at a significance level of 0.05|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in relapse-free survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month relapse-free survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.||32.0|8.9|< 0.01
74066655|NCT01339910|147685703|SUPERIORITY||||||<|0.001||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of disease relapse during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of disease relapse was compared between treatment arms using Gray's test, treating death as a competing risk.||||< 0.001
74066656|NCT01339910|147685704|SUPERIORITY|||||||0.002||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of treatment-related mortality was compared between treatment arms using Gray's test, treating disease relapse as a competing risk.||||0.002
74066657|NCT01339910|147685705|SUPERIORITY|||||||0.002||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of neutrophil engraftment at Day 28 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.||||0.002
74066658|NCT01339910|147685705|SUPERIORITY|||||||0.065||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment at Day 60 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of platelet engraftment at Day 60 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.||||0.065
74066659|NCT01339910|147685706|SUPERIORITY|||||||0.005||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.005
73883252|NCT03583099|147300554|SUPERIORITY||Difference in proportion|0.4||||0.89|TWO_SIDED|95.0|-5.1|5.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.9|-5.1|0.89
74066660|NCT01339910|147685706|SUPERIORITY|||||||0.011||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 100 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.011
74066661|NCT01339910|147685706|SUPERIORITY|||||||0.39||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at 18 months post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.39
74066662|NCT01339910|147685707|SUPERIORITY|||||||0.024||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade II-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade II-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.024
74066663|NCT01339910|147685707|SUPERIORITY|||||||0.066||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade III-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade III-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.066
74066664|NCT01339910|147685708|SUPERIORITY|||||||0.019||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of chronic GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.019
74066665|NCT02555618|147685759|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|1.7|||||TWO_SIDED|95.0|-7.983|11.415|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||11.415|-7.983|
74066666|NCT02555618|147685759|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-4.8|||||TWO_SIDED|95.0|-13.974|4.403|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||4.403|-13.974|
74066667|NCT02555618|147685759|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|2.6|||||TWO_SIDED|95.0|-6.082|11.32|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||11.320|-6.082|
74066668|NCT02555618|147685760|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.7984|1.2253|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.2253|0.7984|
73883253|NCT03583099|147300555|SUPERIORITY||Difference in proportion|-8.8||||0.05|TWO_SIDED|95.0|-17.5|0.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-0.0|-17.5|0.05
74066669|NCT02555618|147685760|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.5544|1.05|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.0500|0.5544|
74066670|NCT02555618|147685760|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.06|||||TWO_SIDED|95.0|0.8134|1.3931|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.3931|0.8134|
74066671|NCT02555618|147685763|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|6.8|||||TWO_SIDED|95.0|-3.02|16.348||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||16.348|-3.020|
74066672|NCT02555618|147685763|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-8.8|||||TWO_SIDED|95.0|-18.282|0.901||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||0.901|-18.282|
74066673|NCT02555618|147685763|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-2.3|||||TWO_SIDED|95.0|-11.461|6.835||||||The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||6.835|-11.461|
74066674|NCT02555618|147685764|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||TWO_SIDED|95.0|0.9559|1.1473|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.1473|0.9559|
74066675|NCT02555618|147685764|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.7862|1.0241|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.0241|0.7862|
74066676|NCT02555618|147685764|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||TWO_SIDED|95.0|0.9273|1.0364|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.0364|0.9273|
73883254|NCT03583099|147300556|SUPERIORITY||Difference in proportion|16.76||||0.09|TWO_SIDED|95.0|-2.89|36.42|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||36.42|-2.89|0.09
74066677|NCT02555618|147685767|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|14.7|||||TWO_SIDED|95.0|5.489|23.577||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||23.577|5.489|
74066678|NCT02555618|147685767|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-1.9|||||TWO_SIDED|95.0|-10.614|6.928||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||6.928|-10.614|
74066679|NCT02555618|147685767|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-2.4|||||TWO_SIDED|95.0|-10.346|5.579||||||The analysis is difference of seroconversion rate between treatment groups for B-Strain.||5.579|-10.346|
74066680|NCT02555618|147685768|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.1221|1.9623|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.9623|1.1221|
74066681|NCT02555618|147685768|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.7806|1.4564|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.4564|0.7806|
74066682|NCT02555618|147685768|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.8166|1.3934|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.3934|0.8166|
74066683|NCT02555618|147685771|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|1.1|||||TWO_SIDED|95.0|-7.195|9.423|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||9.423|-7.195|
74066684|NCT02555618|147685771|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-0.8|||||TWO_SIDED|95.0|-10.369|8.803|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||8.803|-10.369|
74066685|NCT02555618|147685771|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|3.2|||||TWO_SIDED|95.0|-6.406|12.757|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||12.757|-6.406|
74066686|NCT02555618|147685772|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.9106|1.2484|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.2484|0.9106|
74066687|NCT02555618|147685772|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||TWO_SIDED|95.0|0.8686|1.0969|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2-Day 22.||1.0969|0.8686|
74066688|NCT02555618|147685772|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||TWO_SIDED|95.0|0.9622|1.1427|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.1427|0.9622|
74066689|NCT02063698|147685778|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2: BPI Worst Pain Past 24 Hours||||1.0
74066690|NCT02063698|147685778|SUPERIORITY|||||||0.45|||||||Fisher Exact|||Day 3: BPI Worst Pain Past 24 Hours||||0.45
74066691|NCT02063698|147685778|SUPERIORITY|||||||0.38|||||||Fisher Exact|||Day 4: BPI Worst Pain Past 24 Hours||||0.38
74066692|NCT02063698|147685778|SUPERIORITY|||||||0.12|||||||Fisher Exact|||Day 5: BPI Worst Pain Past 24 Hours||||0.12
74066693|NCT02063698|147685778|SUPERIORITY|||||||0.7|||||||Fisher Exact|||Day 6: BPI Worst Pain Past 24 Hours||||0.70
74066694|NCT02063698|147685778|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 7: BPI Worst Pain Past 24 Hours||||1.0
74066695|NCT02063698|147685778|SUPERIORITY|||||||0.44|||||||Fisher Exact|||Day 8: BPI Worst Pain Past 24 Hours||||0.44
74066696|NCT02063698|147685779|SUPERIORITY|||||||0.44|||||||Equal variance t-test|||||||0.44
74066697|NCT02063698|147685780|SUPERIORITY|||||||0.13|||||||Equal variance t-test|||||||0.13
74066698|NCT02063698|147685782|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
74066699|NCT02063698|147685783|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
74066700|NCT02063698|147685784|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
74066701|NCT02063698|147685785|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
73883255|NCT03583099|147300557|SUPERIORITY||Difference in proportion|3.7||||0.56|TWO_SIDED|95.0|-8.6|15.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.9|-8.6|0.56
74066702|NCT02063698|147685786|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
74066703|NCT00591253|147685811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0||||0.001|TWO_SIDED|95.0|-7.97|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.04|-7.97|0.001
74066704|NCT00591253|147685811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|||<|0.001|TWO_SIDED|95.0|-10.69|-4.86||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-4.86|-10.69|<0.001
74066705|NCT00591253|147685812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.48|||<|0.001|TWO_SIDED|95.0|-10.18|-2.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.78|-10.18|<0.001
74066706|NCT00591253|147685812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|||<|0.001|TWO_SIDED|95.0|-10.27|-2.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.81|-10.27|<0.001
74066707|NCT00591253|147685813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44||||0.001|TWO_SIDED|95.0|-5.47|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.40|-5.47|0.001
74066708|NCT00591253|147685813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.77|||<|0.001|TWO_SIDED|95.0|-7.78|-3.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.77|-7.78|<0.001
73883256|NCT03583099|147300558|SUPERIORITY||Difference in proportion|10.41||||0.49|TWO_SIDED|95.0|-19.39|40.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||40.20|-19.39|0.49
73883257|NCT03583099|147300559|SUPERIORITY||Difference in proportion|10.8||||0.06|TWO_SIDED|95.0|-0.5|22.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||22.1|-0.5|0.06
74066709|NCT00591253|147685814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.004|TWO_SIDED|95.0|-5.22|-1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.02|-5.22|0.004
74066710|NCT00591253|147685814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||0.006|TWO_SIDED|95.0|-5.08|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.84|-5.08|0.006
74066711|NCT00591253|147685815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.09||||0.001|TWO_SIDED|95.0|-8.14|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-8.14|0.001
74066712|NCT00591253|147685815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|||<|0.001|TWO_SIDED|95.0|-10.96|-4.97||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.97|-10.96|<0.001
74066713|NCT00591253|147685816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|||<|0.001|TWO_SIDED|95.0|-5.86|-1.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.61|-5.86|<0.001
74066714|NCT00591253|147685816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||<|0.001|TWO_SIDED|95.0|-7.99|-3.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.81|-7.99|<0.001
74066715|NCT00591253|147685817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.91||||0.008|TWO_SIDED|95.0|-8.54|-1.27||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.27|-8.54|0.008
74066716|NCT00591253|147685817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.27|||<|0.001|TWO_SIDED|95.0|-10.85|-3.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.69|-10.85|<0.001
74066717|NCT00591253|147685818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05||||0.024|TWO_SIDED|95.0|-5.69|-0.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.40|-5.69|0.024
74066718|NCT00591253|147685818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.79|||<|0.001|TWO_SIDED|95.0|-8.39|-3.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.19|-8.39|<0.001
74066719|NCT00591253|147685819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.001|TWO_SIDED|95.0|-8.52|-2.08||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.08|-8.52|0.001
74066720|NCT00591253|147685819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.71|||<|0.001|TWO_SIDED|95.0|-10.88|-4.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.55|-10.88|<0.001
74066721|NCT00591253|147685820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.81||||0.001|TWO_SIDED|95.0|-6.08|-1.54||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.54|-6.08|0.001
73883258|NCT03583099|147300560|SUPERIORITY||Difference in proportion|0.41||||0.94|TWO_SIDED|95.0|-10.97|11.79|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.79|-10.97|0.94
73883259|NCT03583099|147300561|SUPERIORITY||Difference in proportion|2.7||||0.57|TWO_SIDED|95.0|-6.5|11.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.8|-6.5|0.57
74066722|NCT00591253|147685820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.65|||<|0.001|TWO_SIDED|95.0|-7.88|-3.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.41|-7.88|<0.001
74066723|NCT00591253|147685821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.86||||0.014|TWO_SIDED|95.0|-8.72|-1.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.01|-8.72|0.014
74066724|NCT00591253|147685821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.71|||<|0.001|TWO_SIDED|95.0|-12.5|-4.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.92|-12.50|<0.001
74066725|NCT00591253|147685822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04||||0.012|TWO_SIDED|95.0|-7.17|-0.91||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.91|-7.17|0.012
74066726|NCT00591253|147685822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.55|||<|0.001|TWO_SIDED|95.0|-10.63|-4.48||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.48|-10.63|<0.001
73883260|NCT03583099|147300562|SUPERIORITY||Difference in proportion|1.36||||0.89|TWO_SIDED|95.0|-18.01|20.73|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||20.73|-18.01|0.89
74066727|NCT00591253|147685823|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.004|TWO_SIDED|95.0|1.27|3.65||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.65|1.27|0.004
74066728|NCT00591253|147685823|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.016|TWO_SIDED|95.0|1.13|3.31||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.31|1.13|0.016
74066729|NCT00591253|147685824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.018|TWO_SIDED|95.0|1.11|3.08||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.08|1.11|0.018
74066730|NCT00591253|147685824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.015|TWO_SIDED|95.0|1.13|3.16||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.16|1.13|0.015
74066731|NCT00591253|147685825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.004|TWO_SIDED|95.0|1.31|4.24||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.24|1.31|0.004
74066732|NCT00591253|147685825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84|||<|0.001|TWO_SIDED|95.0|1.57|5.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.13|1.57|<0.001
74066733|NCT03124381|147685837|NON_INFERIORITY|Non-inferiority concluded if the upper bound of the two-sided 95% confidence interval (based on ANCOVA) is less than 15 percentage points. Terms for treatment, gender, center as factors and baseline as covariate.|Mean Difference (Net)|3.19|STANDARD_ERROR_OF_MEAN|5.164|||TWO_SIDED|95.0|-7.04|13.42||||||Non-inferiority test performed after significance vs. baseline confirmed for each cell. The null hypothesis for the non-inferiority test was H0: A-B≥15%, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Gel-Cream + Acne Mask cell and Acne Mask cell, respectively.||13.42|-7.04|
73883261|NCT03583099|147300563|SUPERIORITY||Difference in proportion|-2.2||||0.65|TWO_SIDED|95.0|-12.1|7.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.6|-12.1|0.65
74066734|NCT03124381|147685837|SUPERIORITY|Superiority concluded if the upper bound of the two-sided 95% confidence interval of the treatment difference is less than 0. Terms for treatment, gender, and center as factors and baseline score as covariate.|Mean Difference (Net)|3.19|STANDARD_ERROR_OF_MEAN|5.164||0.538|TWO_SIDED|95.0|-7.04|13.42|||ANCOVA|||Superiority test performed after non-inferiority confirmed as described above. The null hypothesis for the superiority test was H0: A-B = 0, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Acne Mask and the Gel-Cream + Acne Mask cell, respectively.||13.42|-7.04|0.538
74066735|NCT01841359|147685896|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
74066736|NCT01841359|147685897|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.08
74066737|NCT01841359|147685898|OTHER||||||=|0.20492|||||||t-test, 2 sided|||||||= 0.20492
74066738|NCT01841359|147685899|OTHER|||||||0.2655|||||||t-test, 2 sided|||||||0.2655
74066739|NCT01841359|147685900|OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
74066740|NCT01841359|147685901|OTHER|||||||0.597|||||||t-test, 2 sided|||||||0.597
74066741|NCT01841359|147685902|OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
74066742|NCT01841359|147685903|OTHER|||||||0.14|||||||t-test, 2 sided|||||||0.14
74066743|NCT01841359|147685904|OTHER|||||||0.412|||||||t-test, 2 sided|||||||0.412
74066744|NCT01841359|147685905|OTHER|||||||0.89|||||||t-test, 2 sided|||||||0.890
74066745|NCT01841359|147685906|OTHER|||||||0.69|||||||Fisher Exact|||||||0.69
74066746|NCT02151461|147685907|OTHER|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in plasma glucose AUC(0-3hr) at Week 4 in the Day 28 Evaluable population. The model includes factors for treatment group and fasting plasma glucose stratum.||||||0.0435||||||Baseline plasma glucose AUC(0-3hr) is adjusted as a covariate.|ANCOVA|||||||0.0435
74066747|NCT02151461|147685907|OTHER|||||||0.065|||||||ANCOVA|||||||0.065
74066748|NCT02151461|147685907|OTHER|||||||0.1216|||||||ANCOVA|||||||0.1216
74066749|NCT02151461|147685908|OTHER|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in incremental plasma glucose AUC at Week 4 in the Day 28 Evaluable population. The model will include factors for treatment group and fasting plasma glucose stratum.||||||0.8867|||||||ANCOVA|The model includes factors for treatment group and fasting plasma glucose stratum.||||||0.8867
74066750|NCT02151461|147685908|OTHER|||||||0.7641|||||||ANCOVA|||||||0.7641
74066751|NCT02151461|147685908|OTHER|||||||0.2518|||||||ANCOVA|||||||0.2518
74066752|NCT02151461|147685909|OTHER|||||||0.0179|||||||ANCOVA|Total daily dose is twice the respective dose, Pairwise comparison using Treatment D as the reference group||||||0.0179
74066753|NCT02151461|147685909|OTHER|||||||0.0736|||||||ANCOVA|||||||0.0736
74066754|NCT02151461|147685909|OTHER|||||||0.0475|||||||ANCOVA|||||||0.0475
74066755|NCT02151461|147685910|OTHER|||||||0.0089|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group||||||0.0089
74066756|NCT02151461|147685910|OTHER|||||||0.376|||||||ANCOVA|||||||0.376
74066757|NCT02151461|147685910|OTHER|||||||0.0578|||||||ANCOVA|||||||0.0578
74066758|NCT02151461|147685911|OTHER|||||||0.2177|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group||The HOMA Calculator,is an algorithm that takes account of variations in hepatic and peripheral glucose resistance, increases in insulin secretion curve for plasma glucose concentrations above 10 mmol/L (180 mg/dL), and contribution of circulating proinsulin (eg, C-peptide) to estimate steady state beta cell function (%HOMA-B) and insulin sensitivity (%HOMA-S), as percentages of a normal reference population. %HOMA-IR was analyzed on a logarithmic scale (natural logarithmic transformation).||||0.2177
74066759|NCT02151461|147685911|OTHER|||||||0.4144|||||||ANCOVA|||||||0.4144
74066760|NCT02151461|147685911|OTHER|||||||0.3117|||||||ANCOVA|||||||0.3117
74066761|NCT02151461|147685912|OTHER|Average Change in Pre-meal Glucose Level||||||0.011|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.011
74066762|NCT02151461|147685912|OTHER|Average Change in Pre-meal Glucose Level||||||0.0152|||||||ANCOVA|||||||0.0152
74066763|NCT02151461|147685912|OTHER|Average Change in Pre-meal Glucose Level||||||0.0284|||||||ANCOVA|||||||0.0284
74066764|NCT02151461|147685912|OTHER|Average Change in Post-meal Glucose Level||||||0.1273|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.1273
74066765|NCT02151461|147685912|OTHER|Average Change in Post-meal Glucose Level||||||0.0085|||||||ANCOVA|||||||0.0085
74066766|NCT02151461|147685912|OTHER|Average Change in Post-meal Glucose Level||||||0.1289|||||||ANCOVA|||||||0.1289
74066767|NCT02151461|147685913|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.3143|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise comparison using Treatment D as the reference group.||||||0.3143
74066768|NCT02151461|147685913|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.5677|||||||ANCOVA|||||||0.5677
74066769|NCT02151461|147685913|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.8407|||||||ANCOVA|||||||0.8407
74066770|NCT02151461|147685914|OTHER|||||||0.9789|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.9789
74066771|NCT02151461|147685914|OTHER|||||||0.841|||||||ANCOVA|||||||0.841
74066772|NCT02151461|147685914|OTHER|||||||0.748|||||||ANCOVA|||||||0.748
74066773|NCT01102777|147685926|SUPERIORITY_OR_OTHER|||||||0.142|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value of outcome, MMRC dyspnea score, and urban versus rural residence.||||||0.142
74066774|NCT01102777|147685927|SUPERIORITY_OR_OTHER|||||||0.502|TWO_SIDED||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group\*time interaction, MMRC score, and urban versus rural residence.||||||.502
74066775|NCT01102777|147685928|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value and rural residence.||||||.90
74066776|NCT01102777|147685929|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value and rural residence.||||||.93
74066777|NCT01102777|147685930|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Zero inflated Poisson regression|Adjusted for age, gender, oxygen use, and arm.||||||.08
74066778|NCT01102777|147685931|SUPERIORITY_OR_OTHER|||||||0.731|TWO_SIDED||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group\*time interaction, MMRC score, and urban versus rural residence.||||||0.731
74066779|NCT01102777|147685932|SUPERIORITY_OR_OTHER|||||||0.52|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.||||||.52
74066780|NCT01102777|147685933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|||||||||The determination of arm occurred after recruitment, and Study Reach is a recruitment value.||||
74066781|NCT01102777|147685934|SUPERIORITY_OR_OTHER|||||||0.11|||||||Regression, Linear|Adjusting for time, MMRC score, and urban versus rural residence.||||||.11
74066782|NCT01102777|147685935|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.||||||.01
74066783|NCT01154153|147685970|SUPERIORITY_OR_OTHER||Treatment Ratio of Geometric mean|0.966|||||TWO_SIDED|95.0|0.892|1.045|||ANCOVA||The treatment ratio was calculated as an exponential of the mean difference between treatments in log scale.|Missing cortisol values were imputed with multiple imputation. AUC(0-24 hr) was calculated for each imputation and analyzed with log-transformation using an ANCOVA model and analyzed with treatment, sex, and age group as fixed effects, and log-transformed baseline value as a covariate. The mean difference in log scale between treatments and its standard error were calculated by Least Squares mean. Results from multiply imputed data were combined using SAS procedure MIANALYZE.||1.045|0.892|
74066784|NCT01154153|147685971|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.24||0.0007|TWO_SIDED|95.0|-1.34|-0.37|||ANCOVA|For ANCOVA, treatment arm, randomization strata were fixed effects and baseline value was a covariate.||||-0.37|-1.34|0.0007
74066785|NCT01154153|147685972|SUPERIORITY_OR_OTHER|||||||0.1332||95.0||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.1332
74066786|NCT01154153|147685973|SUPERIORITY_OR_OTHER|||||||0.3314||95.0||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.3314
74066787|NCT01086215|147685996|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
74066788|NCT01086215|147685996|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
74066789|NCT01086215|147685996|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
74066790|NCT01086215|147685996|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
74066791|NCT01965652|147686000|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|STANDARD_ERROR_OF_MEAN|0.226|<|0.0001|TWO_SIDED|95.0|0.83|1.72||The significance level was set at 0.05 (2-sided). The analysis of efficacy endpoints was not adjusted for multiplicity; hence, the p-values are purely nominal. A mixed-effects model repeated measures (MMRM) method was used for the comparisons.|Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||1.72|0.83|<0.0001
74066792|NCT01965652|147686000|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.53|1.47|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||1.47|0.53|<0.0001
74066793|NCT01965652|147686000|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|0.52|1.5|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||1.50|0.52|<0.0001
74066794|NCT01965652|147686000|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.259||0.0001|TWO_SIDED|95.0|0.49|1.51|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||1.51|0.49|0.0001
74066795|NCT01965652|147686002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.44|-0.25|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.25|-0.44|<0.0001
74066796|NCT01965652|147686002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.14|-0.36|<0.0001
74066797|NCT01965652|147686002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.4|-0.18|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.18|-0.40|<0.0001
74066798|NCT01965652|147686002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.47|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.24|-0.47|<0.0001
74066799|NCT01965652|147686002|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.35|-0.12|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.12|-0.35|<0.0001
74066800|NCT01965652|147686003|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.054||0.0002|TWO_SIDED|95.0|-0.31|-0.1|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.10|-0.31|0.0002
74066801|NCT01965652|147686003|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0173|TWO_SIDED|95.0|-0.26|-0.03|||Mixed-effects model repeated meaures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.03|-0.26|0.0173
73883262|NCT03583099|147300564|SUPERIORITY||Difference in proportion|12.48||||0.16|TWO_SIDED|95.0|-5.0|29.96|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||29.96|-5.00|0.16
74066802|NCT01965652|147686003|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.061||0.0035|TWO_SIDED|95.0|-0.3|-0.06|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.06|-0.30|0.0035
74066803|NCT01965652|147686003|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.4|-0.16|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.16|-0.40|<0.0001
74066804|NCT01965652|147686003|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.064||0.0336|TWO_SIDED|95.0|-0.26|-0.01|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.01|-0.26|0.0336
74066805|NCT01965652|147686004|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.37|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.14|-0.37|<0.0001
74066806|NCT01965652|147686004|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.063||0.0114|TWO_SIDED|95.0|-0.28|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.04|-0.28|0.0114
74066807|NCT01965652|147686004|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065||0.0003|TWO_SIDED|95.0|-0.36|-0.11|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.11|-0.36|0.0003
74066808|NCT01965652|147686004|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.13|-0.38|<0.0001
74066809|NCT01965652|147686004|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.066||0.0119|TWO_SIDED|95.0|-0.29|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.04|-0.29|0.0119
74066810|NCT01965652|147686005|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.64|-0.39|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.39|-0.64|<0.0001
74066811|NCT01965652|147686005|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.51|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.26|-0.51|<0.0001
73883263|NCT03583099|147300565|SUPERIORITY||Difference in proportion|4.3||||0.29|TWO_SIDED|95.0|-3.6|12.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.2|-3.6|0.29
74066812|NCT01965652|147686005|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.54|-0.27|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.27|-0.54|<0.0001
74066813|NCT01965652|147686005|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|-0.62|-0.34|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.34|-0.62|<0.0001
74066814|NCT01965652|147686005|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.52|-0.23|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.23|-0.52|<0.0001
74066815|NCT01965652|147686006|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|-0.49|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.30|-0.49|<0.0001
74066816|NCT01965652|147686006|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.46|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.26|-0.46|<0.0001
74066817|NCT01965652|147686006|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.43|-0.22|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.22|-0.43|<0.0001
74066818|NCT01965652|147686006|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.29|-0.50|<0.0001
74066819|NCT01965652|147686006|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.42|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.20|-0.42|<0.0001
74066820|NCT01965652|147686007|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.5|-0.28|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.28|-0.50|<0.0001
74066821|NCT01965652|147686007|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.44|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Anaysis||-0.20|-0.44|<0.0001
74066822|NCT01965652|147686007|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|-0.4|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.15|-0.40|<0.0001
74066823|NCT01965652|147686007|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001|TWO_SIDED|95.0|-0.48|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.21|-0.48|<0.0001
74066824|NCT01965652|147686007|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.41|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.15|-0.41|<0.0001
74066825|NCT01965652|147686008|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.34|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.14|-0.34|<0.0001
74066826|NCT01965652|147686008|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.35|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.14|-0.35|<0.0001
74066827|NCT01965652|147686008|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.14|-0.36|<0.0001
74066828|NCT01965652|147686008|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.43|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.19|-0.43|<0.0001
74066829|NCT01965652|147686008|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.061||0.0006|TWO_SIDED|95.0|-0.33|-0.09|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.09|-0.33|0.0006
74066830|NCT01965652|147686009|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.29|-0.50|<0.0001
74066831|NCT01965652|147686009|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.48|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.24|-0.48|<0.0001
74066832|NCT01965652|147686009|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.45|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.21|-0.45|<0.0001
74066833|NCT01965652|147686009|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.54|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.30|-0.54|<0.0001
74066834|NCT01965652|147686009|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|-0.44|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.19|-0.44|<0.0001
74066835|NCT01965652|147686010|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.81|-0.53|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.53|-0.81|<0.0001
74066836|NCT01965652|147686010|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.73|-0.43|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.43|-0.73|<0.0001
73883264|NCT03583099|147300566|SUPERIORITY||Difference in proportion|5.28||||0.44|TWO_SIDED|95.0|-8.07|18.62|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||18.62|-8.07|0.44
74066837|NCT01965652|147686010|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.077|<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.36|-0.66|<0.0001
74066838|NCT01965652|147686010|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.69|-0.38|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.38|-0.69|<0.0001
74066839|NCT01965652|147686010|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.64|-0.32|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.32|-0.64|<0.0001
74066840|NCT01965652|147686011|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74066841|NCT02524106|147686012|OTHER||percentage difference|61.0||||0.028|TWO_SIDED||||||Mixed Models Analysis|||||||0.028
74066842|NCT02524106|147686013|OTHER||percentage difference|39.0||||0.096|TWO_SIDED||||||Mixed Models Analysis|||||||0.096
74066843|NCT01121900|147686014|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 80% and 125%.|Mean ratio|39.8|||||TWO_SIDED|90.0|34.4|46.0|||||Test/reference (%)|||46.0|34.4|
74066844|NCT01121900|147686015|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-tlast) is between 80% and 125%.|Mean ratio|80.9|||||TWO_SIDED|90.0|74.2|88.3|||||Test/reference (%)|||88.3|74.2|
74066845|NCT01121900|147686016|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|83.5|||||TWO_SIDED|90.0|76.5|91.1|||||Test/reference (%)|||91.1|76.5|
74066846|NCT01328054|147686021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.31|STANDARD_ERROR_OF_MEAN|2.151|||TWO_SIDED|90.0|2.72|9.89|||||Confidence interval (CI), estimated value and dispersion value of is presented for pre dose|||9.89|2.72|
74066847|NCT01328054|147686021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.43|STANDARD_ERROR_OF_MEAN|2.059|||TWO_SIDED|90.0|3.0|9.87|||||CI, estimated value and dispersion value of is presented for 1 hour post dose|||9.87|3.00|
74066848|NCT01328054|147686021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.71|STANDARD_ERROR_OF_MEAN|1.734|||TWO_SIDED|90.0|4.82|10.6|||||CI, estimated value and dispersion value of is presented for 2 hour post dose|||10.60|4.82|
74066849|NCT01328054|147686021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.42|STANDARD_ERROR_OF_MEAN|2.085|||TWO_SIDED|90.0|2.94|9.89|||||CI, estimated value and dispersion value of is presented for 3 hour post dose|||9.89|2.94|
74066850|NCT01328054|147686021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.434|||TWO_SIDED|90.0|2.54|10.65|||||CI, estimated value and dispersion value of is presented for 4 hour post dose|||10.65|2.54|
74066851|NCT01328054|147686021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|STANDARD_ERROR_OF_MEAN|2.573|||TWO_SIDED|90.0|1.57|10.14|||||CI, estimated value and dispersion value of is presented for 6 hour post dose|||10.14|1.57|
74066852|NCT01328054|147686021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.91|STANDARD_ERROR_OF_MEAN|2.735|||TWO_SIDED|90.0|0.35|9.47|||||CI, estimated value and dispersion value of is presented for 8 hour post dose|||9.47|0.35|
74066853|NCT01328054|147686021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.75|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|90.0|4.08|13.42|||||CI, estimated value and dispersion value of is presented for 10 hour post dose|||13.42|4.08|
74066854|NCT01328054|147686021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.76|STANDARD_ERROR_OF_MEAN|2.759|||TWO_SIDED|90.0|1.16|10.36|||||CI, estimated value and dispersion value of is presented for 12 hour post dose|||10.36|1.16|
74066855|NCT01328054|147686021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|2.164|||TWO_SIDED|90.0|0.15|7.36|||||CI, estimated value and dispersion value of is presented for 24 hour post dose|||7.36|0.15|
74066856|NCT05478603|147686041|OTHER||Ratio of adjusted geometric means|94.88|||||TWO_SIDED|90.0|70.86|127.04|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||127.04|70.86|
74066857|NCT05478603|147686041|OTHER||Ratio of adjusted geometric means|99.75|||||TWO_SIDED|90.0|74.5|133.56|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||133.56|74.50|
74066858|NCT05478603|147686041|OTHER||Ratio of adjusted geometric means|68.7|||||TWO_SIDED|90.0|51.31|91.98|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||91.98|51.31|
74066859|NCT05478603|147686042|OTHER||Ratio of adjusted geometric means|101.87|||||TWO_SIDED|90.0|59.74|173.71|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||173.71|59.74|
73883265|NCT03583099|147300567|SUPERIORITY||Difference in proportion|-1.5||||0.62|TWO_SIDED|95.0|-7.6|4.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.5|-7.6|0.62
73883266|NCT03583099|147300568|SUPERIORITY||Difference in proportion|-7.1||||0.39|TWO_SIDED|95.0|-23.18|9.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.0|-23.18|0.39
73883267|NCT03583099|147300569|SUPERIORITY||Difference in proportion|-6.6||||0.08|TWO_SIDED|95.0|-13.9|0.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.8|-13.9|0.08
73883268|NCT03583099|147300570|SUPERIORITY||Difference in proportion|-11.3||||0.23|TWO_SIDED|95.0|-29.06|7.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.00|-29.06|0.23
73883269|NCT03583099|147300571|SUPERIORITY||Difference in means|-1.14||||0.97|TWO_SIDED|95.0|-6.42|4.13||The p-value adjusts for baseline CAT score.|Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.13|-6.42|0.97
73883270|NCT03583099|147300572|SUPERIORITY||Difference in means|-0.003||||0.47|TWO_SIDED|95.0|-1.86|1.85|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.85|-1.86|0.47
74066860|NCT05478603|147686042|OTHER||Ratio of adjusted geometric means|156.07|||||TWO_SIDED|90.0|91.53|266.14|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||266.14|91.53|
74066861|NCT05478603|147686042|OTHER||Ratio of adjusted geometric means|96.48|||||TWO_SIDED|90.0|56.58|164.51|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||164.51|56.58|
74066862|NCT05478603|147686043|OTHER||Ratio of adjusted geometric means|102.21|||||TWO_SIDED|90.0|59.91|174.39|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||174.39|59.91|
74066863|NCT05478603|147686043|OTHER||Ratio of adjusted geometric means|152.91|||||TWO_SIDED|90.0|89.62|260.9|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||260.90|89.62|
74066864|NCT05478603|147686043|OTHER||Ratio of adjusted geometric means|97.08|||||TWO_SIDED|90.0|56.9|165.65|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||165.65|56.90|
73883271|NCT03583099|147300573|SUPERIORITY||Difference in proportion|17.84||||0.02|TWO_SIDED|95.0|2.34|33.34|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||33.34|2.34|0.02
74066865|NCT05478603|147686044|OTHER||Ratio of adjusted geometric means|93.29|||||TWO_SIDED|90.0|64.61|134.69|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||134.69|64.61|
74066866|NCT05478603|147686044|OTHER||Ratio of adjusted geometric means|106.68|||||TWO_SIDED|90.0|73.89|154.03|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||154.03|73.89|
74066867|NCT05478603|147686044|OTHER||Ratio of adjusted geometric means|246.28|||||TWO_SIDED|90.0|170.57|355.58|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||355.58|170.57|
74066868|NCT05478603|147686045|OTHER||Ratio of adjusted geometric means|88.5|||||TWO_SIDED|90.0|64.13|122.12|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||122.12|64.13|
74066869|NCT05478603|147686045|OTHER||Ratio of adjusted geometric means|106.4|||||TWO_SIDED|90.0|77.11|146.83|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||146.83|77.11|
74066870|NCT05478603|147686045|OTHER||Ratio of adjusted geometric means|169.19|||||TWO_SIDED|90.0|122.61|233.47|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||233.47|122.61|
74066871|NCT05478603|147686046|OTHER||Ratio of adjusted geometric means|95.12|||||TWO_SIDED|90.0|52.6|172.03|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||172.03|52.60|
74066872|NCT05478603|147686046|OTHER||Ratio of adjusted geometric means|166.77|||||TWO_SIDED|90.0|92.21|301.62|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||301.62|92.21|
74066873|NCT05478603|147686046|OTHER||Ratio of adjusted geometric means|237.76|||||TWO_SIDED|90.0|131.46|430.0|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||430.00|131.46|
74066874|NCT05478603|147686047|OTHER||Ratio of adjusted geometric means|95.34|||||TWO_SIDED|90.0|52.67|172.59|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||172.59|52.67|
74066875|NCT05478603|147686047|OTHER||Ratio of adjusted geometric means|163.09|||||TWO_SIDED|90.0|90.1|295.22|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||295.22|90.10|
74066876|NCT05478603|147686047|OTHER||Ratio of adjusted geometric means|239.47|||||TWO_SIDED|90.0|132.29|433.47|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||433.47|132.29|
74066877|NCT00291330|147686058|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.05|||<|0.0001||95.0|0.65|1.7||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.70|0.65|<0.0001
74066878|NCT00291330|147686058|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 3.6% for the risk difference based on KM estimates|Risk Difference (Percentage)|0.4|||<|0.0001||95.0|-0.8|1.5||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.50|-0.80|<0.0001
74066879|NCT00291330|147686058|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||||95.0|0.65|1.84|||Regression, Cox|Patients without events are censored at day 180||Hazard ratio vs. Warfarin (events occurring between randomisation and the day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.84|0.65|
74066880|NCT00291330|147686059|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.622||95.0|-1.0|1.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.70|-1.00|0.6220
74066881|NCT00291330|147686059|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9844||95.0|0.69|1.46|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.46|0.69|0.9844
73883272|NCT03583099|147300574|SUPERIORITY||Difference in proportion|7.8||||0.12|TWO_SIDED|95.0|-2.0|17.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.6|-2.0|0.12
73883273|NCT03583099|147300575|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test. This test is appropriate since only one outcome per practice was seen.||||||1.0
73883274|NCT03583099|147300576|SUPERIORITY||Difference in proportion|2.06||||0.87|TWO_SIDED|95.0|-22.67|26.79|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||26.79|-22.67|0.87
73883275|NCT03583099|147300577|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
73883276|NCT03583099|147300578|SUPERIORITY||Difference in proportion|-5.53||||0.56|TWO_SIDED|95.0|-24.33|13.28|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.28|-24.33|0.56
74066882|NCT00291330|147686060|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.2||||0.6466||95.0|-1.1|0.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.70|-1.10|0.6466
74066883|NCT00291330|147686060|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.385||95.0|0.4|1.42|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.42|0.40|0.3850
73883277|NCT03583099|147300579|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
74066884|NCT00291330|147686061|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.2981||95.0|-0.3|1.0|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.00|-0.30|0.2981
74066885|NCT00291330|147686061|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.1092||95.0|0.86|4.68|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||4.68|0.86|0.1092
74066886|NCT00291330|147686062|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.3||||0.5327||95.0|-1.2|0.6|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.60|-1.20|0.5327
74066887|NCT00291330|147686062|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.3332||95.0|0.03|3.15|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||3.15|0.03|0.3332
74066888|NCT00291330|147686063|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.1||||0.8018||95.0|-1.0|0.8|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.80|-1.00|0.8018
74066889|NCT00291330|147686063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8203||95.0|0.54|1.63|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.63|0.54|0.8203
73883278|NCT03583099|147300580|SUPERIORITY||Difference in proportion|12.66||||0.21|TWO_SIDED|95.0|-7.05|32.37|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||32.37|-7.05|0.21
73883279|NCT03583099|147300581|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
73883280|NCT03583099|147300582|SUPERIORITY||Difference in proportion|-18.29||||0.08|TWO_SIDED|95.0|-38.66|2.08|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.08|-38.66|0.08
73883281|NCT03583099|147300583|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
73883282|NCT03583099|147300584|SUPERIORITY||Difference in proportion|-0.67||||0.92|TWO_SIDED|95.0|-14.06|12.71|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.71|-14.06|0.92
73883283|NCT03583099|147300586|SUPERIORITY||Difference in proportion|-5.47||||0.29|TWO_SIDED|95.0|-15.72|4.77|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.77|-15.72|0.29
73883284|NCT03583099|147300588|SUPERIORITY||Difference in proportion|-2.87||||0.69|TWO_SIDED|95.0|-17.14|11.39|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.39|-17.14|0.69
73883285|NCT03583099|147300589|SUPERIORITY||Difference in proportion|-13.15||||0.32|TWO_SIDED|95.0|-39.06|12.76|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.76|-39.06|0.32
73883286|NCT03583099|147300590|SUPERIORITY||Difference in proportion|-0.2||||0.98|TWO_SIDED|95.0|-15.5|15.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.0|-15.5|0.98
73883287|NCT03583099|147300592|SUPERIORITY||Difference in proportion|3.1||||0.55|TWO_SIDED|95.0|-7.0|13.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.1|-7.0|0.55
73883288|NCT03583099|147300593|SUPERIORITY||Difference in proportion|-8.61||||0.43|TWO_SIDED|95.0|-30.19|12.97|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.97|-30.19|0.43
73883289|NCT03583099|147300594|SUPERIORITY||Difference in proportion|7.6||||0.1|TWO_SIDED|95.0|-1.4|16.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.5|-1.4|0.10
73883290|NCT03583099|147300595|SUPERIORITY||Difference in proportion|0.82||||0.94|TWO_SIDED|95.0|-20.92|21.92|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||21.92|-20.92|0.94
73883291|NCT03583099|147300596|SUPERIORITY||Difference in proportion|-3.4||||0.55|TWO_SIDED|95.0|-14.4|7.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.6|-14.4|0.55
73883292|NCT03583099|147300598|SUPERIORITY||Difference in proportion|-1.1||||0.8|TWO_SIDED|95.0|-9.3|7.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.1|-9.3|0.80
73883293|NCT03583099|147300600|SUPERIORITY||Difference in proportion|-3.9||||0.18|TWO_SIDED|95.0|-9.7|1.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.8|-9.7|0.18
73883294|NCT03583099|147300601|SUPERIORITY||Difference in proportion|-0.17||||0.99|TWO_SIDED|95.0|-26.06|25.72|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.72|-26.06|0.99
73883295|NCT03583099|147300602|SUPERIORITY||Difference in proportion|-2.6||||0.59|TWO_SIDED|95.0|-12.0|6.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.8|-12.0|0.59
73883296|NCT03583099|147300604|SUPERIORITY||Difference in proportion|1.9||||0.82|TWO_SIDED|95.0|-14.5|18.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||18.4|-14.5|0.82
73883297|NCT03583099|147300606|SUPERIORITY||Difference in proportion|7.6||||0.2|TWO_SIDED|95.0|-4.1|19.3|||Wilcoxon (Mann-Whitney)||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||19.3|-4.1|0.20
73883298|NCT03583099|147300608|SUPERIORITY||Difference in proportion|4.9||||0.36|TWO_SIDED|95.0|-5.5|15.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.3|-5.5|0.36
73883299|NCT03583099|147300610|SUPERIORITY||Difference in proportion|4.6||||0.47|TWO_SIDED|95.0|-7.9|17.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.1|-7.9|0.47
74066890|NCT00291330|147686064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.5063||95.0|0.45|1.48|||Regression, Cox|||Hazard ratio vs. Warfarin for the category major bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.48|0.45|0.5063
74066891|NCT00291330|147686064|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Regression, Cox|||Hazard ratio vs. Warfarin for the category of any bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||0.85|0.59|0.0002
73883300|NCT03583099|147300612|SUPERIORITY||Difference in proportion|0.6||||0.88|TWO_SIDED|95.0|-7.8|9.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.0|-7.8|0.88
74066892|NCT00566709|147686068|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
74066893|NCT00566709|147686069|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Chi-squared, Corrected|||||||0.07
74066894|NCT00566709|147686070|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Chi-squared, Corrected|||||||0.56
74066895|NCT00566709|147686071|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
74066896|NCT00566709|147686072|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Chi-squared, Corrected|||||||0.77
74066897|NCT00566709|147686073|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Chi-squared, Corrected|||||||0.22
73883301|NCT03583099|147300614|SUPERIORITY||Difference in proportion|-4.3||||0.27|TWO_SIDED|95.0|-12.0|3.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.4|-12.0|0.27
74066898|NCT03443869|147686079|NON_INFERIORITY|LET was concluded non-inferior to VGCV if the upper bound of the two-sided 95% CI for difference in percentage of participants with adjudicated CMV disease (LET - VGCV) was no higher than 10%|Stratum-adjusted Treatment Difference|-1.4|||||TWO_SIDED|95.0|-6.5|3.8|||||Difference = LET minus VGCV|The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures||3.8|-6.5|
74066899|NCT03443869|147686080|OTHER||Stratum-adjusted Treatment Difference|-1.7|||||TWO_SIDED|95.0|-3.4|0.1|||||Difference = LET minus VGCV|The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures||0.1|-3.4|
74066900|NCT03443869|147686082|OTHER||Difference in Percentages|-0.1|||||TWO_SIDED|95.0|-4.4|4.2|||||Difference = LET minus VGCV|||4.2|-4.4|
74066901|NCT03443869|147686083|OTHER||Difference in Percentages|-3.7|||||TWO_SIDED|95.0|-7.0|-0.9|||||Difference = LET minus VGCV|||-0.9|-7.0|
74066902|NCT00678392|147686131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665|||<|0.0001|TWO_SIDED|95.0|0.544|0.812||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group (ECOG) and prior treatment. One-sided log-rank test at 0.025 level of significance was used to compare PFS between the 2 treatment arms.|Log Rank|||||0.812|0.544|<0.0001
74066903|NCT00678392|147686132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.969||||0.3744|TWO_SIDED|95.0|0.8|1.174|||Log Rank|P-value was obtained from a 1-sided log-rank test of treatment stratified by ECOG performance status and prior treatment.||||1.174|0.800|0.3744
74066904|NCT00678392|147686133|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.056||||0.0001|TWO_SIDED|95.0|1.408|3.003|||Cochran-Mantel-Haenszel|P-value was obtained from a 1-sided Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior treatment.||||3.003|1.408|0.0001
74066905|NCT05117099|147686145|SUPERIORITY|||||||0.548|||||||ANOVA|||||||.548
74066906|NCT05117099|147686147|SUPERIORITY|||||||0.915|||||||ANOVA|||||||.915
74066907|NCT05117099|147686148|SUPERIORITY|||||||0.663|||||||ANOVA|||||||.663
74066908|NCT05117099|147686149|SUPERIORITY|||||||0.138|||||||ANOVA|||||||.138
74066909|NCT05117099|147686150|SUPERIORITY|||||||0.114|||||||ANOVA|||||||.114
74066910|NCT05117099|147686151|SUPERIORITY|||||||0.065|||||||ANOVA|||||||.065
74066911|NCT05117099|147686152|SUPERIORITY|||||||0.394|||||||ANOVA|||||||.394
74066912|NCT05117099|147686153|SUPERIORITY|||||||0.388|||||||ANOVA|||||||.388
74066913|NCT05117099|147686154|SUPERIORITY|||||||0.332|||||||ANOVA|||||||.332
74066914|NCT01614509|147686172|NON_INFERIORITY_OR_EQUIVALENCE|Central retinal thickness was measured using an optical coherence tomography by every visit intended for all participants.||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||Central retinal thickness was measured using an optical coherence tomography by every visit. And we compare the difference of central retinal thickness between two groups||||0.60
74066915|NCT00125931|147686192|SUPERIORITY_OR_OTHER|||||||0.01|ONE_SIDED|95.0|||||ANOVA|||comparison of mean scores at hour 2 vs 3||||0.01
74066916|NCT00125931|147686193|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||comparison of mean score on treatment vs post-treatment days||||0.01
74066917|NCT00125931|147686193|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 1 sided|||comparison of mean scores at pre-treatment vs treatment days||||0.4
74066918|NCT03654898|147686211|SUPERIORITY||cross-tabulation|0.48||||0.49|TWO_SIDED||||||Chi-squared|||||||0.49
74066919|NCT03654898|147686211|SUPERIORITY||Odds Ratio (OR)|1.06||||0.67|TWO_SIDED|95.0|0.8|1.42|||Regression, Logistic|Adjusted logistic regression||||1.42|0.80|0.67
74066920|NCT03654898|147686212|SUPERIORITY||Cross-tabulation|0.71||||0.4|TWO_SIDED||||||Chi-squared|||||||0.40
74066921|NCT03654898|147686213|SUPERIORITY||Cross-tabulation|0.5||||0.78|TWO_SIDED||||||Chi-squared|||Test 1 was for TFVdp while test 2 was for 3TCtp.||||0.78
74066922|NCT03654898|147686213|SUPERIORITY||Cross-tabulation|2.13||||0.34|TWO_SIDED||||||Chi-squared|||Test 2 was for 3TCtp while test 1 was for TFVdp.||||0.34
74066923|NCT01271933|147686214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0186|TWO_SIDED|||||The p-value was calculated using log-rank test for comparing pregabalin CR with placebo|Log Rank|||||||0.0186
74066924|NCT01271933|147686218|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.41||0.331|TWO_SIDED|95.0|-1.2|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||||0.4|-1.2|0.3310
74066925|NCT01271933|147686221|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9247|TWO_SIDED|95.0|-0.8|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.8|-0.8|0.9247
74066926|NCT01271933|147686230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|7.12||0.4314|TWO_SIDED|95.0|-19.7|8.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: Subjective Wake after Sleep Onset||8.5|-19.7|0.4314
74066927|NCT01271933|147686230|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|9.26||0.8915|TWO_SIDED|95.0|-17.1|19.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Subjective Latency to Sleep Onset||19.6|-17.1|0.8915
74066928|NCT01271933|147686231|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.41||0.4571|TWO_SIDED|95.0|-0.5|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||1.1|-0.5|0.4571
74066929|NCT01271933|147686232|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3779|TWO_SIDED|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-0.2|0.3779
74066930|NCT01271933|147686233|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.34||0.2009|TWO_SIDED|95.0|-0.2|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||1.1|-0.2|0.2009
74066931|NCT01271933|147686235|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.1845|TWO_SIDED|95.0|-1.6|0.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.3|-1.6|0.1845
74066932|NCT01271933|147686238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|4.52||0.0305|TWO_SIDED|95.0|-18.9|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep disturbance||1.0|-18.9|0.0305
74066933|NCT01271933|147686238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.17||0.3133|TWO_SIDED|95.0|-5.0|15.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Snoring||15.5|-5.0|0.3133
74066934|NCT01271933|147686238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|3.71||0.2985|TWO_SIDED|95.0|-11.2|3.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Awakening Short of Breath or with a Headache||3.5|-11.2|0.2985
74066935|NCT01271933|147686238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|5.49||0.2159|TWO_SIDED|95.0|-4.1|17.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep adequacy||17.7|-4.1|0.2159
74066936|NCT01271933|147686238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|4.1||0.2041|TWO_SIDED|95.0|-13.4|2.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Somnolence||2.9|-13.4|0.2041
74066937|NCT01271933|147686238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|3.81||0.1319|TWO_SIDED|95.0|-13.4|1.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index I||1.8|-13.4|0.1319
74066938|NCT01271933|147686238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|3.89||0.1473|TWO_SIDED|95.0|-13.4|2.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index II||2.0|-13.4|0.1473
74066939|NCT01271933|147686239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3596|TWO_SIDED|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-0.2|0.3596
74066940|NCT01271933|147686241|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.4985|TWO_SIDED|95.0|0.66|2.36||Nominal p-value for two-sided test.|two-sided test|||"Odds ratio is the probability of the event occurring in Pregabalin 330 - 495 mg/day relative to the event occurring in Placebo for Pregabalin.~Odds ratio \> 1 is in favor of Pregabalin 330 - 495 mg/day."||2.36|0.66|0.4985
73883302|NCT03583099|147300615|SUPERIORITY||Difference in proportion|-4.94||||0.82|TWO_SIDED|95.0|-47.92|38.04|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||38.04|-47.92|0.82
73883303|NCT03583099|147300616|SUPERIORITY||Difference in proportion|-1.1||||0.87|TWO_SIDED|95.0|-14.5|12.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.2|-14.5|0.87
73883304|NCT03583099|147300617|SUPERIORITY||Difference in proportion|-37.6||||0.03|TWO_SIDED|95.0|-71.8|-3.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-3.5|-71.8|0.03
73883305|NCT03583099|147300618|SUPERIORITY||Difference in proportion|2.3||||0.56|TWO_SIDED|95.0|-5.6|10.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.3|-5.6|0.56
73883306|NCT03583099|147300619|SUPERIORITY||Difference in proportion|-23.07||||0.06|TWO_SIDED|95.0|-47.4|1.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.27|-47.40|0.06
73883307|NCT03583099|147300620|SUPERIORITY||Difference in proportion|3.2||||0.39|TWO_SIDED|95.0|-4.0|10.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.4|-4.0|0.39
73883308|NCT03583099|147300621|SUPERIORITY||Difference in proportion|-1.72||||0.84|TWO_SIDED|95.0|-18.24|14.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.80|-18.24|0.84
73883309|NCT03583099|147300622|SUPERIORITY||Difference in proportion|2.0||||0.42|TWO_SIDED|95.0|-2.9|6.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.9|-2.9|0.42
73883310|NCT03583099|147300623|SUPERIORITY||Difference in proportion|-42.09||||0.01|TWO_SIDED|95.0|-74.27|-9.92|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-9.92|-74.27|0.01
73883311|NCT03583099|147300624|SUPERIORITY||Difference in proportion|2.4||||0.47|TWO_SIDED|95.0|-4.2|9.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.1|-4.2|0.47
73883312|NCT03583099|147300625|SUPERIORITY||Difference in proportion|-12.27||||0.34|TWO_SIDED|95.0|-37.72|13.18|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.18|-37.72|0.34
73883313|NCT03583099|147300626|SUPERIORITY||Difference in proportion|2.4||||0.39|TWO_SIDED|95.0|-3.1|7.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.9|-3.1|0.39
73883314|NCT03583099|147300628|SUPERIORITY||Difference in proportion|-1.2||||0.59|TWO_SIDED|95.0|-5.5|3.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.1|-5.5|0.59
73883315|NCT03583099|147300630|SUPERIORITY||Difference in proportion|0.3||||0.94|TWO_SIDED|95.0|-8.2|8.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.8|-8.2|0.94
74066941|NCT01271933|147686243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|4.1||0.74|TWO_SIDED|95.0|-9.5|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Physical Functioning||6.8|-9.5|0.7400
74066942|NCT01271933|147686243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|4.89||0.5938|TWO_SIDED|95.0|-7.1|12.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Physical||12.3|-7.1|0.5938
74066943|NCT01271933|147686243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|4.61||0.4842|TWO_SIDED|95.0|-5.9|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Pain Index||12.4|-5.9|0.4842
74066944|NCT01271933|147686243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|3.45||0.0827|TWO_SIDED|95.0|-12.9|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: SF-36 General Health Perceptions||0.8|-12.9|0.0827
74066945|NCT01271933|147686243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|4.73||0.4561|TWO_SIDED|95.0|-12.09|5.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Vitality||5.8|-12.09|0.4561
74066946|NCT01271933|147686243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|4.31||0.9645|TWO_SIDED|95.0|-8.8|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Social Functioning||8.4|-8.8|0.9645
74066947|NCT01271933|147686243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|5.41||0.7636|TWO_SIDED|95.0|-9.1|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Emotional||12.4|-9.1|0.7636
73883316|NCT03583099|147300631|SUPERIORITY||Difference in proportion|0.6||||0.93|TWO_SIDED|95.0|-12.2|13.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.4|-12.2|0.93
73883317|NCT03583099|147300632|SUPERIORITY||Difference in proportion|-8.2||||0.25|TWO_SIDED|95.0|-22.0|5.7|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.7|-22.0|0.25
74066948|NCT01271933|147686243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|3.54||0.7067|TWO_SIDED|95.0|-5.7|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Mental Health Index||8.4|-5.7|0.7067
74066949|NCT01271933|147686243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.78||0.8352|TWO_SIDED|95.0|-3.9|3.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Component Score||3.2|-3.9|0.8352
74066950|NCT01271933|147686243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.22||0.9347|TWO_SIDED|95.0|-4.2|4.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental Component Score||4.6|-4.2|0.9347
74066951|NCT01271933|147686245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.69||0.1901|TWO_SIDED|95.0|-0.5|2.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-A Anxiety scale||2.3|-0.5|0.1901
74066952|NCT01271933|147686245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.6914|TWO_SIDED|95.0|-1.6|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-D Depression scale||1.0|-1.6|0.6914
74066953|NCT01271933|147686247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.41||0.3721|TWO_SIDED|95.0|-0.5|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 1: Physical activities||1.2|-0.5|0.3721
73883318|NCT03583099|147300633|SUPERIORITY||Difference in proportion|-3.4||||0.48|TWO_SIDED|95.0|-12.7|6.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.0|-12.7|0.48
74066954|NCT01271933|147686247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.64||0.8084|TWO_SIDED|95.0|-1.1|1.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 2: Feel good||1.4|-1.1|0.8084
74066955|NCT01271933|147686247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35||0.6312|TWO_SIDED|95.0|-0.9|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 3: Work missed||0.5|-0.9|0.6312
74066956|NCT01271933|147686247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.57||0.8824|TWO_SIDED|95.0|-1.0|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 4: Do job||1.2|-1.0|0.8824
74066957|NCT01271933|147686247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.49||0.2742|TWO_SIDED|95.0|-1.5|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 5: Pain||0.4|-1.5|0.2742
74066958|NCT01271933|147686247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.852|TWO_SIDED|95.0|-0.8|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 6: Fatigue||1.0|-0.8|0.8520
74066959|NCT01271933|147686247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.55||0.5264|TWO_SIDED|95.0|-1.4|0.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 7: Rested||0.7|-1.4|0.5264
73883319|NCT03583099|147300634|SUPERIORITY||Difference in proportion|3.9||||0.45|TWO_SIDED|95.0|-6.3|14.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.2|-6.3|0.45
73883320|NCT03583099|147300636|SUPERIORITY||Difference in proportion|-2.2||||0.48|TWO_SIDED|95.0|-8.4|3.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.9|-8.4|0.48
73883321|NCT03583099|147300637|SUPERIORITY||Difference in proportion|-0.4||||0.97|TWO_SIDED|95.0|-20.4|19.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||19.5|-20.4|0.97
73883322|NCT03583099|147300638|SUPERIORITY||Difference in proportion|-12.1||||0.04|TWO_SIDED|95.0|-23.5|-0.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-0.6|-23.5|0.04
73883323|NCT03583099|147300639|SUPERIORITY||Difference in proportion|-1.8||||0.39|TWO_SIDED|95.0|-5.8|2.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.3|-5.8|0.39
73883324|NCT03583099|147300640|SUPERIORITY||Difference in proportion|-7.3||||0.06|TWO_SIDED|95.0|-14.9|0.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.4|-14.9|0.06
73883325|NCT03583099|147300641|SUPERIORITY||Difference in proportion|-0.9||||0.82|TWO_SIDED|95.0|-8.8|7.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.0|-8.8|0.82
73883326|NCT03583099|147300642|SUPERIORITY||Difference in proportion|0.6||||0.86|TWO_SIDED|95.0|-6.6|7.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.9|-6.6|0.86
73883327|NCT03583099|147300643|SUPERIORITY||Difference in proportion|-7.4||||0.14|TWO_SIDED|95.0|-17.3|2.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.5|-17.3|0.14
73883328|NCT03583099|147300645|SUPERIORITY||Difference in proportion|-14.66||||0.21|TWO_SIDED|95.0|-37.54|8.22|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.22|-37.54|0.21
73883329|NCT03583099|147300646|SUPERIORITY||Difference in proportion|0.4||||0.76|TWO_SIDED|95.0|-2.0|2.7|||Generalized estimating equation contrast|||||2.7|-2.0|0.76
74066960|NCT01271933|147686247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.55||0.6601|TWO_SIDED|95.0|-1.3|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 8: Stiffness||0.9|-1.3|0.6601
74066961|NCT01271933|147686247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.56||0.8937|TWO_SIDED|95.0|-1.2|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 9: Anxiety||1.0|-1.2|0.8937
74066962|NCT01271933|147686247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.9151|TWO_SIDED|95.0|-1.0|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 10: Depression||0.9|-1.0|0.9151
74066963|NCT01271933|147686247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|3.91||0.9045|TWO_SIDED|95.0|-8.2|7.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the total score||7.3|-8.2|0.9045
74066964|NCT01271933|147686249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.31||0.4606|TWO_SIDED|95.0|-0.4|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: General Fatigue||0.9|-0.4|0.4606
74066965|NCT01271933|147686249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.37||0.4703|TWO_SIDED|95.0|-1.0|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Fatigue||0.5|-1.0|0.4703
74066966|NCT01271933|147686249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.36||0.4009|TWO_SIDED|95.0|-0.4|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced activity||1.0|-0.4|0.4009
74066967|NCT01271933|147686249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.35||0.0695|TWO_SIDED|95.0|-0.1|1.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced motivation||1.3|-0.1|0.0695
74066968|NCT01271933|147686249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.5869|TWO_SIDED|95.0|-0.7|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental fatigue||0.4|-0.7|0.5869
74066969|NCT01271933|147686251|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.29||||0.0296|TWO_SIDED|95.0|1.09|4.81||Nominal p-value for two-sided test.|two-sided test|||This analysis is for the domain: Benefit from treatment||4.81|1.09|0.0296
74066970|NCT01271933|147686251|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29||||0.4691|TWO_SIDED|95.0|0.64|2.61||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Satisfaction from treatment||2.61|0.64|0.4691
74066971|NCT01271933|147686251|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.9577|TWO_SIDED|95.0|0.48|2.01||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Willingness to continue treatment||2.01|0.48|0.9577
74066972|NCT01271933|147686253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.3|STANDARD_ERROR_OF_MEAN|9.85||0.0562|TWO_SIDED|95.0|-0.5|39.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Work Time Missed||39.2|-0.5|0.0562
74066973|NCT01271933|147686253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.96||0.7892|TWO_SIDED|95.0|-7.0|9.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Impairment While Working||9.2|-7.0|0.7892
74066974|NCT01271933|147686253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.82||0.0819|TWO_SIDED|95.0|-0.4|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Activity Impairment||6.8|-0.4|0.0819
74066975|NCT01271933|147686253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.91||0.4135|TWO_SIDED|95.0|-2.2|5.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Overall Work Impairment||5.4|-2.2|0.4135
74066976|NCT01271933|147686264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1224|TWO_SIDED|95.0|-0.1|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.9|-0.1|0.1224
74066977|NCT01271933|147686265|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|4.06||0.768|TWO_SIDED|95.0|-9.3|6.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||6.9|-9.3|0.7680
74066978|NCT01271933|147686266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.136|TWO_SIDED|95.0|-4.5|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-4.5|0.1360
74066979|NCT01271933|147686267|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6489.5|STANDARD_ERROR_OF_MEAN|12579.5||0.6077|TWO_SIDED|95.0|-18648.6|31627.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Total daytime activity||31627.6|-18648.6|0.6077
74066980|NCT01271933|147686268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.38||0.6647|TWO_SIDED|95.0|-2.2|3.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||3.4|-2.2|0.6647
74066981|NCT01335464|147686348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|125.26|STANDARD_ERROR_OF_MEAN|24.209|<|0.0001|TWO_SIDED|95.0|77.68|172.84||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix~Nintedanib 150 mg bid versus Placebo"|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."||172.84|77.68|<0.0001
74066982|NCT01335464|147686349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.248||0.9657|TWO_SIDED|95.0|-2.5|2.4|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.||2.40|-2.50|0.9657
74066983|NCT01335464|147686350|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6728|TWO_SIDED|95.0|0.54|2.42|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard Ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||2.42|0.54|0.6728
74066984|NCT01335464|147686351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|109.93|STANDARD_ERROR_OF_MEAN|19.708|<|0.0001|TWO_SIDED|95.0|71.27|148.59|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||148.59|71.27|<0.0001
74066985|NCT01335464|147686352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.02|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|2.54|5.5|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||5.50|2.54|<0.0001
74066986|NCT01335464|147686353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|0.564|<|0.0001|TWO_SIDED|95.0|2.11|4.33|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||4.33|2.11|<0.0001
74066987|NCT01335464|147686354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|2.52|5.48|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||5.48|2.52|<0.0001
74066988|NCT01335464|147686357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.914||||0.0007|TWO_SIDED|95.0|1.32|2.79|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||2.79|1.32|0.0007
74066989|NCT01335464|147686358|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.847||||0.001|TWO_SIDED|95.0|1.28|2.66|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||2.66|1.28|0.0010
74066990|NCT01335464|147686359|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4298|TWO_SIDED|95.0|0.55|1.29|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score||1.29|0.55|0.4298
74066991|NCT01335464|147686360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|1.744||0.1832|TWO_SIDED|95.0|-5.74|1.1|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.||1.10|-5.74|0.1832
74066992|NCT01335464|147686361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.446||0.551|TWO_SIDED|95.0|-1.97|3.7|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ Impact component-by-visit and random effect for patient||3.70|-1.97|0.5510
74066993|NCT01335464|147686362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|1.427||0.4049|TWO_SIDED|95.0|-3.99|1.61|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient||1.61|-3.99|0.4049
73883330|NCT03583099|147300649|SUPERIORITY||Difference in proportion|0.6||||0.66|TWO_SIDED|95.0|-2.1|3.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.4|-2.1|0.66
73883331|NCT01706458|147300657|OTHER|||||||0.906|||||||Log Rank|||||||0.9060
73883332|NCT04742556|147300692|OTHER||Probability of true DLT rate in [0.33-1]|0.0051||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
73883333|NCT04742556|147300692|OTHER||Probability of true DLT rate in [0.33-1]|0.03105||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
73883334|NCT04742556|147300692|OTHER||Probability of true DLT rate in [0.33-1]|0.27405||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
74066994|NCT01335464|147686363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|1.289||0.5446|TWO_SIDED|95.0|-3.31|1.75|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.||1.75|-3.31|0.5446
74066995|NCT01335464|147686364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|1.77||0.6203|TWO_SIDED|95.0|-4.35|2.6|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.||2.60|-4.35|0.6203
74066996|NCT01335464|147686365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|1.803||0.8942|TWO_SIDED|95.0|-3.78|3.3|||Mixed Models Analysis||"Within- patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.||3.30|-3.78|0.8942
74066997|NCT01335464|147686366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.596||0.3042|TWO_SIDED|95.0|-1.49|4.77|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.||4.77|-1.49|0.3042
74066998|NCT01335464|147686367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.276||||0.1818|TWO_SIDED|95.0|0.89|1.83|||Regression, Logistic||Nintedanib 150mg versus placebo|Logistic regression with term treatment||1.83|0.89|0.1818
74066999|NCT01335464|147686369|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.6793|TWO_SIDED|95.0|0.56|2.46|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150mg bid versus placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.||2.46|0.56|0.6793
74067000|NCT01335464|147686370|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.288|TWO_SIDED|95.0|0.29|1.36|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||1.36|0.29|0.2880
74067001|NCT01335464|147686371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.3515|TWO_SIDED|95.0|0.25|1.47|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.47|0.25|0.3515
74067002|NCT01335464|147686372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.4869|TWO_SIDED|95.0|0.26|1.82|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||1.82|0.26|0.4869
74067003|NCT01335464|147686373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.443|TWO_SIDED|95.0|0.36|1.51|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.51|0.36|0.4430
74067004|NCT01335464|147686374|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.3558|TWO_SIDED|95.0|0.52|1.25|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.25|0.52|0.3558
74067005|NCT01335464|147686375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.181||0.1138|TWO_SIDED|95.0|-0.07|0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.||0.64|-0.07|0.1138
74067006|NCT01335464|147686376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.0896||0.865|TWO_SIDED|95.0|-0.191|0.161|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) \[mmol/min/kPa\], baseline DLCO (HGB Corrected) \[mmol/min/kPa\]-by-visit and random effect for patient.||0.161|-0.191|0.8650
73883335|NCT03631940|147300701|SUPERIORITY||Least squares mean difference|-0.49||||0.87|TWO_SIDED|95.0|-6.36|5.37|||Hierarchical generalized linear mixed mo|Hierarchical generalized linear mixed models||||5.37|-6.36|.87
73883336|NCT01903356|147300718|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of % of HbA1c before and 24 weeks after administration of TrajentaDuo® Tablet treatment.|The difference considered in the analysis is HbA1c values after drug administration minus HbA1c values before drug administration|||<0.0001
73883337|NCT01903356|147300721|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of FPG before and 24 weeks after administration of TrajentaDuo® Tablet treatment|The difference considered in the analysis is FPG values after drug administration minus FPG values before drug administration|||<0.0001
73883338|NCT04196686|147300728|OTHER||Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.25|0.51|||Cox mixed effects model|||||0.51|0.25|<0.001
73883339|NCT04196686|147300729|OTHER||Mean Difference (Net)|0.455||||0.2|TWO_SIDED|95.0|0.32|0.59|||Linear mixed effects model|||Analysis was controlled for dominant hand treatment assignment, dominant hand order, and gender. Overall mean difference calculated from regression model.||0.59|0.32|0.200
73883340|NCT04196686|147300730|OTHER||Mean Difference (Net)|0.002||||0.047|TWO_SIDED|95.0|0.00007|0.00368|||Linear mixed effects model|||The variables in the physiologic model were SCRD change over time and the SCRD change between groups, defined as those with and without VR.||0.00368|0.00007|0.047
74067007|NCT01504867|147686386|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wald|This was a large sample (Wald) test estimated using a conditional logistic regression model with site as a stratification variable.||The primary outcome significance level was adjusted for multiple testing associated with the interim analysis. Its significance level is 92.6%||||0.53
74067008|NCT01504867|147686387|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>0.99
74067009|NCT01504867|147686388|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.36
74067010|NCT01504867|147686389|SUPERIORITY_OR_OTHER|||||||0.23|||||||Chi-squared|||||||0.23
74067011|NCT01504867|147686390|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
74067012|NCT01504867|147686391|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|||||||0.08
73888303|NCT01746901|147309547|SUPERIORITY_OR_OTHER||LS Mean Difference|88.6||||0.0952|TWO_SIDED|95.0|-15.7|192.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||192.9|-15.7|0.0952
74067013|NCT01504867|147686392|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
74067014|NCT01365845|147686395|SUPERIORITY_OR_OTHER||Non-parametric paired t-test (Wilcoxon)|29.1||||0.0078|||||||Wilcoxon (Mann-Whitney)|||||||0.0078
74067015|NCT02110706|147686400|OTHER|"A futility (non-superiority) design is a screening tool to identify whether agents should be candidates for phase III trials while minimizing costs/sample size If futility is declared, results would imply not cost effective to conduct a future phase III clinical trial If futility is not declared, suggests that there could be a clinically meaningful effect - supports exploration in a larger, phase III trial"|Odds Ratio (OR)|1.14||||0.03|ONE_SIDED|90.0||2.41|||Regression, Logistic|||"This futility design tests the following hypothesis:~H0: Rituximab improves outcome by at least 30% compared to placebo (pR - pP ≥ 0.30 - not futile) versus HA: Rituximab does not improve outcome by at least 30% compared to placebo (pR - pP \< 0.30 - futile)"||2.41||0.03
74067016|NCT02110706|147686401|SUPERIORITY||Odds Ratio (OR)|0.72||||0.63|TWO_SIDED|90.0|0.23|2.21|||t-test, 2 sided|||% of study participants with treatment related AEs||2.21|0.23|0.63
74067017|NCT02110706|147686401|SUPERIORITY||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|90.0|0.27|2.11|||t-test, 2 sided|||% study participants with treatment related SAEs||2.11|0.27|0.65
74067018|NCT02110706|147686402|OTHER||Mean Difference (Final Values)|-0.11||||0.93|ONE_SIDED|90.0||2.02|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the MGC. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline MGC scores.||2.02||0.93
74067019|NCT02110706|147686403|OTHER||Mean Difference (Final Values)|-1.09||||0.39|ONE_SIDED|90.0||1.03|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the QMG. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline QMG scores.||1.03||0.39
74067020|NCT03210259|147686404|EQUIVALENCE|Equivalence was concluded if the confidence interval (CI) for the least squares (LS) means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Least squares means ratio|105.19|||||TWO_SIDED|90.2|96.58|114.64|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm in the numerator and the continuous arm in the denominator.|The null hypothesis was that the ratio of expected means for Switching vs. Continuous Humira is less than 80.00% or more than 125.00%.||114.64|96.58|
74067021|NCT03210259|147686405|EQUIVALENCE|Equivalence was concluded if the confidence interval (CI) for the LS means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Least squares means ratio|101.14|||||TWO_SIDED|90.2|93.26|109.7|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm in the numerator and the continuous arm in the denominator.|The null hypothesis was that the ratio of expected means for Switching vs. Continuous Humira is less than 80.00% or more than 125.00%.||109.70|93.26|
74067022|NCT03210259|147686406|OTHER||Least squares means ratio|107.31|||||TWO_SIDED|90.2|97.33|118.43|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm as numerator and the continuous arm as the denominator.|No hypothesis was defined and no statistical test was performed.||118.43|97.33|
74067023|NCT03210259|147686408|OTHER||Risk Difference (RD)|5.75|||||TWO_SIDED|90.0|-2.45|13.96|||||Risk difference was calculated as Switching arm minus Continuous Humira.|No hypothesis was tested.||13.96|-2.45|
74067024|NCT03210259|147686409|OTHER||Risk Difference (RD)|5.63|||||TWO_SIDED|90.0|-4.35|15.62|||||Risk difference was calculated as Switching arm minus Continuous Humira.|No hypothesis was tested.||15.62|-4.35|
74067025|NCT00252187|147686420|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||Change in end systolic LV volume index compared between two groups||||0.004
74067026|NCT00252187|147686420|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Change in LV end diastolic volume was compared between two groups||||0.001
74067027|NCT00252187|147686421|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
74067028|NCT00252187|147686423|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
74067029|NCT00252187|147686424|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
74067030|NCT03764059|147686428|NON_INFERIORITY|The test for non-inferiority is based on a 95% CI of the difference between the investigational and control groups with respect to the rate of clinically acceptable restorations at 1-year post placement. The non-inferiority margin was 7%. To establish non-inferiority the lower limit has to be \> -7%|Risk Difference (RD)|4.2|||<|0.0001|TWO_SIDED|95.0||9.2|||Cochran-Mantel-Haenszel|||||9.2|- 0.6|< 0.0001
74067031|NCT00210626|147686440|SUPERIORITY_OR_OTHER|||||||0.3807||95.0|||||ANCOVA|Covariate used is Baseline SF-36 PF Score. Baseline SF-36 PF Score was collected prior to the start of Procrit or Placebo treatment||The null hypothesis is that there is no difference between Procrit and Placebo in average SF-36 Physical Function Scores||||0.3807
74067032|NCT00210626|147686441|SUPERIORITY_OR_OTHER|||||||0.7038||95.0|||||Chi-squared|||||||0.7038
73888304|NCT01746901|147309548|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0298|TWO_SIDED|95.0|-3.3|-0.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.2|-3.3|0.0298
74067033|NCT02473510|147686442|SUPERIORITY_OR_OTHER||Rate Difference|0.4|||||TWO_SIDED|95.0|-5.2|2.6||||||||2.6|-5.2|
74067034|NCT02473510|147686443|SUPERIORITY_OR_OTHER||Rate Difference|16.7|||||TWO_SIDED|95.0|3.6|27.6||||||Up to Day 8||27.6|3.6|
74067035|NCT02473510|147686443|SUPERIORITY_OR_OTHER||Rate Difference|17.9|||||TWO_SIDED|95.0|4.4|29.3||||||Up to Day 15||29.3|4.4|
74067036|NCT01261325|147686452|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over PBO|22.8|||<|0.001|TWO_SIDED|95.0|13.3|31.2||"Type I error rate of 0.05 based on a Hochberg multiple comparison procedure would be considered statistically significant or similar, as accurate and appropriate."|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||31.2|13.3|<0.001
74067037|NCT01261325|147686452|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over PBO|23.2|||<|0.001|TWO_SIDED|95.0|13.8|31.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||31.6|13.8|<0.001
74067038|NCT01261325|147686453|SUPERIORITY_OR_OTHER_LEGACY||Odds ratio (BRV versus PBO)|2.39|||<|0.001|TWO_SIDED|95.0|1.6|3.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||3.6|1.6|<0.001
74067039|NCT01261325|147686453|SUPERIORITY_OR_OTHER_LEGACY||Odds ratio (BRV versus PBO)|2.19|||<|0.001|TWO_SIDED|95.0|1.5|3.3||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||3.3|1.5|<0.001
74067040|NCT01261325|147686454|SUPERIORITY_OR_OTHER_LEGACY||Median difference vs placebo|15.8|||<|0.001|TWO_SIDED|95.0|7.6|24.2||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.|||24.2|7.6|<0.001
74067041|NCT01261325|147686454|SUPERIORITY_OR_OTHER_LEGACY||Median difference vs placebo|18.1|||<|0.001|TWO_SIDED|95.0|10.4|26.4||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.|||26.4|10.4|<0.001
74067042|NCT01261325|147686458|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.56|0.82||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.82|0.56|<0.001
74067043|NCT01261325|147686458|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.54|0.79||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.79|0.54|<0.001
74067044|NCT01261325|147686459|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.53|0.8||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.80|0.53|<0.001
74067045|NCT01261325|147686459|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.47|0.71||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.71|0.47|<0.001
74067046|NCT01261325|147686460|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.009|TWO_SIDED|95.0|0.6|0.93||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||0.93|0.60|0.009
74067047|NCT01261325|147686460|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||<|0.001|TWO_SIDED|95.0|0.55|0.85||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||0.85|0.55|<0.001
73883341|NCT02212015|147300731|OTHER||Rate|0.46|||||TWO_SIDED|||||||||Question is, if 6 months progression free survival rate (PFS-R) denoted by pPFS is higher than 35%. Test hypothesis is thus formulated as: H0: pPFS ≤0.35 versus H1: pPFS ≥0.35. This hypothesis is tested at the one-side significance level of 0.05. A 6 months PFS-R of 0.55 of cases or more is considered as clinically relevant success rate. The design is chosen such that rates of 0.55 or higher can be detected with a power of at least 0.8.||||
74067048|NCT00990561|147686491|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis = there is no difference between using ultravate once daily vs. twice daily||||<0.001
74067049|NCT00408876|147686492|SUPERIORITY_OR_OTHER|||||||0.503||95.0|||||Repeated Measures|||||||0.503
74067050|NCT00408876|147686492|SUPERIORITY_OR_OTHER|||||||0.447||95.0|||||Repeated Measures|||||||0.447
73883342|NCT02212015|147300732|SUPERIORITY||Rate difference|0.486|||||TWO_SIDED|||||||||||||
73883343|NCT02212015|147300733|SUPERIORITY||Rate difference|0.0|||||TWO_SIDED|||||||||||||
74067051|NCT00408876|147686492|SUPERIORITY_OR_OTHER|||||||0.084||95.0|||||Repeated Measures|||||||0.084
74067052|NCT00408876|147686492|SUPERIORITY_OR_OTHER|||||||0.964||95.0|||||Repeated Measures|||||||0.964
74067053|NCT00408876|147686492|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||Repeated Measures|||||||0.451
74067054|NCT00408876|147686492|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||Repeated Measures|||||||0.333
74067055|NCT00408876|147686493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.318||95.0|-0.62|0.2|||t-test, 2 sided|||||0.20|-0.62|0.318
74067056|NCT00408876|147686493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.005||95.0|-0.83|-0.15|||t-test, 2 sided|||||-0.15|-0.83|0.005
74067057|NCT00408876|147686493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.124||95.0|-0.61|0.07|||t-test, 2 sided|||||0.07|-0.61|0.124
74067058|NCT00408876|147686493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.183||95.0|-0.7|0.13|||t-test, 2 sided|||||0.13|-0.70|0.183
74067059|NCT00408876|147686493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.778||95.0|-0.48|0.36|||t-test, 2 sided|||||0.36|-0.48|0.778
74067060|NCT00408876|147686493|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.21||95.0|-0.13|0.57|||t-test, 2 sided|||||0.57|-0.13|0.210
74067061|NCT00408876|147686494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.161||95.0|-2.32|0.39|||t-test, 2 sided|||||0.39|-2.32|0.161
74067062|NCT00408876|147686494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.41||||0.019||95.0|-2.59|-0.24|||t-test, 2 sided|||||-0.24|-2.59|0.019
74067063|NCT00408876|147686494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56||||0.01||95.0|-2.74|-0.38|||t-test, 2 sided|||||-0.38|-2.74|0.010
74067064|NCT00408876|147686494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.526||95.0|-1.83|0.94|||t-test, 2 sided|||||0.94|-1.83|0.526
74067065|NCT00408876|147686494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.397||95.0|-1.96|0.78|||t-test, 2 sided|||||0.78|-1.96|0.397
74067066|NCT00408876|147686494|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.813||95.0|-1.35|1.06|||t-test, 2 sided|||||1.06|-1.35|0.813
74067067|NCT00408876|147686495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.657||95.0|-0.5|0.79|||t-test, 2 sided|||||0.79|-0.50|0.657
74067068|NCT00408876|147686495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.384||95.0|-0.76|0.29|||t-test, 2 sided|||||0.29|-0.76|0.384
74067069|NCT00408876|147686495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.04||95.0|-1.1|-0.03|||t-test, 2 sided|||||-0.03|-1.10|0.040
74067070|NCT00408876|147686495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.253||95.0|-1.03|0.27|||t-test, 2 sided|||||0.27|-1.03|0.253
74067071|NCT00408876|147686495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.034||95.0|-1.36|-0.05|||t-test, 2 sided|||||-0.05|-1.36|0.034
74067072|NCT00408876|147686495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33||||0.232||95.0|-0.86|0.21|||t-test, 2 sided|||||0.21|-0.86|0.232
74067073|NCT00408876|147686496|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.365||95.0|-0.39|1.05|||t-test, 2 sided|||||1.05|-0.39|0.365
74067074|NCT00408876|147686496|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.232||95.0|-0.95|0.23|||t-test, 2 sided|||||0.23|-0.95|0.232
74067075|NCT00408876|147686496|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.314||95.0|-0.9|0.29|||t-test, 2 sided|||||0.29|-0.90|0.314
74067076|NCT00408876|147686496|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69||||0.062||95.0|-1.41|0.03|||t-test, 2 sided|||||0.03|-1.41|0.062
74067077|NCT00408876|147686496|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.083||95.0|-1.36|0.08|||t-test, 2 sided|||||0.08|-1.36|0.083
74067078|NCT00408876|147686496|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.859||95.0|-0.54|0.65|||t-test, 2 sided|||||0.65|-0.54|0.859
74067079|NCT00408876|147686497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.984||95.0|-0.34|0.34|||t-test, 2 sided|||||0.34|-0.34|0.984
74067080|NCT00408876|147686497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.004||95.0|-0.7|-0.13|||t-test, 2 sided|||||-0.13|-0.70|0.004
74067081|NCT00408876|147686497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.81|-0.24|||t-test, 2 sided|||||-0.24|-0.81|<0.001
74067082|NCT00408876|147686497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.018||95.0|-0.76|-0.07|||t-test, 2 sided|||||-0.07|-0.76|0.018
74067083|NCT00408876|147686497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.003||95.0|-0.87|-0.19|||t-test, 2 sided|||||-0.19|-0.87|0.003
74067084|NCT00408876|147686497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.442||95.0|-0.4|0.17|||t-test, 2 sided|||||0.17|-0.40|0.442
74067085|NCT00408876|147686498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31||||0.464||95.0|-0.52|1.14|||t-test, 2 sided|||||1.14|-0.52|0.464
74067086|NCT00408876|147686498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68||||0.052||95.0|-1.36|0.0|||t-test, 2 sided|||||0.00|-1.36|0.052
74067087|NCT00408876|147686498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68||||0.052||95.0|-1.37|0.01|||t-test, 2 sided|||||0.01|-1.37|0.052
74067088|NCT00408876|147686498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99||||0.021||95.0|-1.83|-0.15|||t-test, 2 sided|||||-0.15|-1.83|0.021
74067089|NCT00408876|147686498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99||||0.02||95.0|-1.83|-0.16|||t-test, 2 sided|||||-0.16|-1.83|0.020
74067090|NCT00408876|147686498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.988||95.0|-0.7|0.69|||t-test, 2 sided|||||0.69|-0.70|0.988
74067091|NCT00408876|147686499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.543||95.0|-0.46|0.88|||t-test, 2 sided|||||0.88|-0.46|0.543
74067092|NCT00408876|147686499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.053||95.0|-1.1|0.01|||t-test, 2 sided|||||0.01|-1.10|0.053
74067093|NCT00408876|147686499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.024||95.0|-1.21|-0.09|||t-test, 2 sided|||||-0.09|-1.21|0.024
74067094|NCT00408876|147686499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.75||||0.03||95.0|-1.43|-0.07|||t-test, 2 sided|||||-0.07|-1.43|0.030
74067095|NCT00408876|147686499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.014||95.0|-1.54|-0.17|||t-test, 2 sided|||||-0.17|-1.54|0.014
74067096|NCT00408876|147686499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.727||95.0|-0.66|0.46|||t-test, 2 sided|||||0.46|-0.66|0.727
74067097|NCT00408876|147686500|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.813||95.0|-0.63|0.8|||t-test, 2 sided|||||0.80|-0.63|0.813
74067098|NCT00408876|147686500|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.035||95.0|-1.21|-0.04|||t-test, 2 sided|||||-0.04|-1.21|0.035
74067099|NCT00408876|147686500|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.054||95.0|-1.17|0.01|||t-test, 2 sided|||||0.01|-1.17|0.054
74067100|NCT00408876|147686500|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.051||95.0|-1.43|0.0|||t-test, 2 sided|||||0.00|-1.43|0.051
74067101|NCT00408876|147686500|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.67||||0.07||95.0|-1.39|0.05|||t-test, 2 sided|||||0.05|-1.39|0.070
74067102|NCT00408876|147686500|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.872||95.0|-0.54|0.64|||t-test, 2 sided|||||0.64|-0.54|0.872
74067103|NCT00408876|147686501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.79||95.0|-0.68|0.89|||t-test, 2 sided|||||0.89|-0.68|0.790
74067104|NCT00408876|147686501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93||||0.005||95.0|-1.57|-0.28|||t-test, 2 sided|||||-0.28|-1.57|0.005
74067105|NCT00408876|147686501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.009||95.0|-1.52|-0.22|||t-test, 2 sided|||||-0.22|-1.52|0.009
74067106|NCT00408876|147686501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03||||0.011||95.0|-1.83|-0.24|||t-test, 2 sided|||||-0.24|-1.83|0.011
74067107|NCT00408876|147686501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.016||95.0|-1.77|-0.18|||t-test, 2 sided|||||-0.18|-1.77|0.016
74067108|NCT00408876|147686501|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.857||95.0|-0.6|0.72|||t-test, 2 sided|||||0.72|-0.60|0.857
74067109|NCT00408876|147686502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.948||95.0|-0.81|0.76|||t-test, 2 sided|||||0.76|-0.81|0.948
74067110|NCT00408876|147686502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.096||95.0|-1.2|0.1|||t-test, 2 sided|||||0.10|-1.20|0.096
74067111|NCT00408876|147686502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.239||95.0|-1.05|0.26|||t-test, 2 sided|||||0.26|-1.05|0.239
74067112|NCT00408876|147686502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.196||95.0|-1.32|0.27|||t-test, 2 sided|||||0.27|-1.32|0.196
74067113|NCT00408876|147686502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.367||95.0|-1.17|0.43|||t-test, 2 sided|||||0.43|-1.17|0.367
74067114|NCT00408876|147686502|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.637||95.0|-0.5|0.82|||t-test, 2 sided|||||0.82|-0.50|0.637
74067115|NCT00408876|147686503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.887||95.0|-0.76|0.65|||t-test, 2 sided|||||0.65|-0.76|0.887
74067116|NCT00408876|147686503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.006||95.0|-1.4|-0.23|||t-test, 2 sided|||||-0.23|-1.40|0.006
74067117|NCT00408876|147686503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.392||95.0|-0.84|0.33|||t-test, 2 sided|||||0.33|-0.84|0.392
74067118|NCT00408876|147686503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.036||95.0|-1.48|-0.05|||t-test, 2 sided|||||-0.05|-1.48|0.036
74067119|NCT00408876|147686503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.573||95.0|-0.92|0.51|||t-test, 2 sided|||||0.51|-0.92|0.573
74067120|NCT00408876|147686503|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.064||95.0|-0.03|1.15|||t-test, 2 sided|||||1.15|-0.03|0.064
74067121|NCT00408876|147686504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.374||95.0|-1.15|0.43|||t-test, 2 sided|||||0.43|-1.15|0.374
74067122|NCT00408876|147686504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.007||95.0|-1.55|-0.25|||t-test, 2 sided|||||-0.25|-1.55|0.007
74067123|NCT00408876|147686504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.169||95.0|-1.12|0.2|||t-test, 2 sided|||||0.20|-1.12|0.169
74067124|NCT00408876|147686504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.182||95.0|-1.35|0.26|||t-test, 2 sided|||||0.26|-1.35|0.182
74067125|NCT00408876|147686504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.802||95.0|-0.91|0.7|||t-test, 2 sided|||||0.70|-0.91|0.802
74067126|NCT00408876|147686504|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44||||0.191||95.0|-0.22|1.11|||t-test, 2 sided|||||1.11|-0.22|0.191
74067127|NCT00408876|147686505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.556||95.0|-1.1|0.59|||t-test, 2 sided|||||0.59|-1.10|0.556
74067128|NCT00408876|147686505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73||||0.041||95.0|-1.42|-0.03|||t-test, 2 sided|||||-0.03|-1.42|0.041
74067129|NCT00408876|147686505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.22||95.0|-1.14|0.26|||t-test, 2 sided|||||0.26|-1.14|0.220
74067130|NCT00408876|147686505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.278||95.0|-1.33|0.38|||t-test, 2 sided|||||0.38|-1.33|0.278
74067131|NCT00408876|147686505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.673||95.0|-1.04|0.68|||t-test, 2 sided|||||0.68|-1.04|0.673
74067132|NCT00408876|147686505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29||||0.422||95.0|-0.42|1.0|||t-test, 2 sided|||||1.00|-0.42|0.422
74067133|NCT00408876|147686506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.234||95.0|-1.03|0.25|||t-test, 2 sided|||||0.25|-1.03|0.234
74067134|NCT00408876|147686506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93|||<|0.001||95.0|-1.46|-0.4|||t-test, 2 sided|||||-0.40|-1.46|<0.001
74067135|NCT00408876|147686506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.213||95.0|-0.87|0.2|||t-test, 2 sided|||||0.20|-0.87|0.213
74067136|NCT00408876|147686506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.105||95.0|-1.19|0.11|||t-test, 2 sided|||||0.11|-1.19|0.105
74067137|NCT00408876|147686506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.876||95.0|-0.6|0.7|||t-test, 2 sided|||||0.70|-0.60|0.876
74067138|NCT00408876|147686506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59||||0.033||95.0|0.05|1.13|||t-test, 2 sided|||||1.13|0.05|0.033
74067139|NCT00408876|147686507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.925||95.0|-0.73|0.8|||t-test, 2 sided|||||0.80|-0.73|0.925
74067140|NCT00408876|147686507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.008||95.0|-1.49|-0.22|||t-test, 2 sided|||||-0.22|-1.49|0.008
74067141|NCT00408876|147686507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.132||95.0|-1.12|0.15|||t-test, 2 sided|||||0.15|-1.12|0.132
74067142|NCT00408876|147686507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89||||0.024||95.0|-1.67|-0.12|||t-test, 2 sided|||||-0.12|-1.67|0.024
74067143|NCT00408876|147686507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.184||95.0|-1.3|0.25|||t-test, 2 sided|||||0.25|-1.30|0.184
74067144|NCT00408876|147686507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37||||0.262||95.0|-0.27|1.01|||t-test, 2 sided|||||1.01|-0.27|0.262
74067145|NCT00408876|147686508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.849||95.0|-0.84|0.69|||t-test, 2 sided|||||0.69|-0.84|0.849
74067146|NCT00408876|147686508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73||||0.024||95.0|-1.36|-0.1|||t-test, 2 sided|||||-0.10|-1.36|0.024
74067147|NCT00408876|147686508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.773||95.0|-0.73|0.54|||t-test, 2 sided|||||0.54|-0.73|0.773
74067148|NCT00408876|147686508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.097||95.0|-1.43|0.12|||t-test, 2 sided|||||0.12|-1.43|0.097
74067149|NCT00408876|147686508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.96||95.0|-0.79|0.75|||t-test, 2 sided|||||0.75|-0.79|0.960
74067150|NCT00408876|147686508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0.052||95.0|0.0|1.28|||t-test, 2 sided|||||1.28|0.00|0.052
74067151|NCT00408876|147686509|SUPERIORITY_OR_OTHER|||||||0.756||95.0|||||Repeated Measures|||||||0.756
74067152|NCT00408876|147686509|SUPERIORITY_OR_OTHER|||||||0.507||95.0|||||Repeated Measures|||||||0.507
74067153|NCT00408876|147686509|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||Repeated Measures|||||||0.056
74067154|NCT00408876|147686509|SUPERIORITY_OR_OTHER|||||||0.816||95.0|||||Repeated Measures|||||||0.816
74067155|NCT00408876|147686509|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Repeated Measures|||||||0.208
74067156|NCT00408876|147686509|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Repeated Measures|||||||0.212
74067157|NCT00408876|147686510|SUPERIORITY_OR_OTHER|||||||0.885||95.0|||||Repeated Measures|||||||0.885
74067158|NCT00408876|147686510|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
74067159|NCT00408876|147686510|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
74067160|NCT00408876|147686510|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Repeated Measures|||||||0.095
74067161|NCT00408876|147686510|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Repeated Measures|||||||0.040
74067162|NCT00408876|147686510|SUPERIORITY_OR_OTHER|||||||0.635||95.0|||||Repeated Measures|||||||0.635
74067163|NCT00408876|147686511|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Repeated Measures|||||||0.575
74067164|NCT00408876|147686511|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Repeated Measures|||||||0.009
74067165|NCT00408876|147686511|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
74067166|NCT00408876|147686511|SUPERIORITY_OR_OTHER|||||||0.115||95.0|||||Repeated Measures|||||||0.115
74067167|NCT00408876|147686511|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures|||||||0.002
74067168|NCT00408876|147686511|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Repeated Measures|||||||0.072
74067169|NCT00408876|147686512|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||Repeated Measures|||||||0.516
74067170|NCT00408876|147686512|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Repeated Measures|||||||0.006
74067171|NCT00408876|147686512|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
74067172|NCT00408876|147686512|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||Repeated Measures|||||||0.112
74067173|NCT00408876|147686512|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Repeated Measures|||||||0.010
74067174|NCT00408876|147686512|SUPERIORITY_OR_OTHER|||||||0.219||95.0|||||Repeated Measures|||||||0.219
74067175|NCT00408876|147686513|SUPERIORITY_OR_OTHER|||||||0.309||95.0|||||Repeated Measures|||||||0.309
74067176|NCT00408876|147686513|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Repeated Measures|||||||0.001
74067177|NCT00408876|147686513|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
74067178|NCT00408876|147686513|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Repeated Measures|||||||0.116
74067179|NCT00408876|147686513|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Repeated Measures|||||||0.033
74067180|NCT00408876|147686513|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Repeated Measures|||||||0.480
74067181|NCT00408876|147686514|SUPERIORITY_OR_OTHER|||||||0.709||95.0|||||Repeated Measures|||||||0.709
74067182|NCT00408876|147686514|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Repeated Measures|||||||0.012
74067183|NCT00408876|147686514|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Repeated Measures|||||||0.001
74067184|NCT00408876|147686514|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Repeated Measures|||||||0.097
74067185|NCT00408876|147686514|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Repeated Measures|||||||0.023
74067186|NCT00408876|147686514|SUPERIORITY_OR_OTHER|||||||0.435||95.0|||||Repeated Measures|||||||0.435
74067187|NCT00408876|147686515|SUPERIORITY_OR_OTHER|||||||0.931||95.0|||||Repeated Measures|||||||0.931
74067188|NCT00408876|147686515|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
74067189|NCT00408876|147686515|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
74067190|NCT00408876|147686515|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Repeated Measures|||||||0.036
74067191|NCT00408876|147686515|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
74067192|NCT00408876|147686515|SUPERIORITY_OR_OTHER|||||||0.416||95.0|||||Repeated Measures|||||||0.416
74067193|NCT00408876|147686516|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||Repeated Measures|||||||0.634
74067194|NCT00408876|147686516|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Repeated Measures|||||||0.031
74067195|NCT00408876|147686516|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures|||||||0.002
74067196|NCT00408876|147686516|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
74067197|NCT00408876|147686516|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Repeated Measures|||||||0.003
74067198|NCT00408876|147686516|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Repeated Measures|||||||0.313
74067199|NCT00408876|147686517|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Repeated Measures|||||||0.910
74067200|NCT00408876|147686517|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
74067201|NCT00408876|147686517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
73883344|NCT02212015|147300734|OTHER||Median|21.6|||||TWO_SIDED|||||||||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||
73883345|NCT02212015|147300735|SUPERIORITY|||||||0.752|||||||Log Rank|||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) for subgroup 1 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||0.752
74067202|NCT00408876|147686517|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Repeated Measures|||||||0.090
74067203|NCT00408876|147686517|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Repeated Measures|||||||0.006
73883346|NCT02212015|147300736|SUPERIORITY|||||||0.621|||||||Log Rank|||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) for subgroup 2 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||0.621
74067204|NCT00408876|147686517|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Repeated Measures|||||||0.171
74067205|NCT00408876|147686518|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||Repeated Measures|||||||0.733
74067206|NCT00408876|147686518|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Repeated Measures|||||||0.022
74067207|NCT00408876|147686518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
74067208|NCT00408876|147686518|SUPERIORITY_OR_OTHER|||||||0.128||95.0|||||Repeated Measures|||||||0.128
74067209|NCT00408876|147686518|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Repeated Measures|||||||0.013
74067210|NCT00408876|147686518|SUPERIORITY_OR_OTHER|||||||0.225||95.0|||||Repeated Measures|||||||0.225
74067211|NCT00408876|147686519|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Repeated Measures|||||||0.890
74067212|NCT00408876|147686519|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Repeated Measures|||||||0.079
74067213|NCT00408876|147686519|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Repeated Measures|||||||0.035
73883347|NCT02212015|147300737|OTHER||||||||||||||||||Frequency of each category is given|||
74067214|NCT00408876|147686519|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||Repeated Measures|||||||0.117
74067215|NCT00408876|147686519|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Repeated Measures|||||||0.060
74067216|NCT00408876|147686519|SUPERIORITY_OR_OTHER|||||||0.647||95.0|||||Repeated Measures|||||||0.647
74067217|NCT00408876|147686520|SUPERIORITY_OR_OTHER|||||||0.243||95.0|||||Repeated Measures|||||||0.243
74067218|NCT00408876|147686520|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Repeated Measures|||||||0.110
74067219|NCT00408876|147686520|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Repeated Measures|||||||0.236
74067220|NCT00408876|147686520|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Repeated Measures|||||||0.014
74067221|NCT00408876|147686520|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Repeated Measures|||||||0.036
74067222|NCT00408876|147686520|SUPERIORITY_OR_OTHER|||||||0.756||95.0|||||Repeated Measures|||||||0.756
74067223|NCT00408876|147686521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.465||95.0|-0.84|0.39|||t-test, 2 sided|||||0.39|-0.84|0.465
74067224|NCT00408876|147686521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79||||0.002||95.0|-1.3|-0.29|||t-test, 2 sided|||||-0.29|-1.30|0.002
74067225|NCT00408876|147686521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.233||95.0|-0.82|0.2|||t-test, 2 sided|||||0.20|-0.82|0.233
74067226|NCT00408876|147686521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.075||95.0|-1.19|0.06|||t-test, 2 sided|||||0.06|-1.19|0.075
74067227|NCT00408876|147686521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.798||95.0|-0.71|0.54|||t-test, 2 sided|||||0.54|-0.71|0.798
74067228|NCT00408876|147686521|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||0.066||95.0|-0.03|1.0|||t-test, 2 sided|||||1.00|-0.03|0.066
74067229|NCT00408876|147686522|SUPERIORITY_OR_OTHER|||||||0.869||95.0|||||Fisher Exact|||||||0.869
74067230|NCT00408876|147686522|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Fisher Exact|||||||0.141
74067231|NCT00408876|147686522|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|||||||0.033
74067232|NCT00408876|147686522|SUPERIORITY_OR_OTHER|||||||0.142||95.0|||||Fisher Exact|||||||0.142
74067233|NCT00408876|147686522|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||Fisher Exact|||||||0.049
74067234|NCT00408876|147686522|SUPERIORITY_OR_OTHER|||||||0.587||95.0|||||Fisher Exact|||||||0.587
74067235|NCT00408876|147686523|SUPERIORITY_OR_OTHER|||||||0.356||95.0|||||Fisher Exact|||||||0.356
74067236|NCT00408876|147686523|SUPERIORITY_OR_OTHER|||||||0.472||95.0|||||Fisher Exact|||||||0.472
74067237|NCT00408876|147686523|SUPERIORITY_OR_OTHER|||||||0.255||95.0|||||Fisher Exact|||||||0.255
74067238|NCT00408876|147686523|SUPERIORITY_OR_OTHER|||||||0.107||95.0|||||Fisher Exact|||||||0.107
74067239|NCT00408876|147686523|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||Fisher Exact|||||||0.053
74067240|NCT00408876|147686523|SUPERIORITY_OR_OTHER|||||||0.779||95.0|||||Fisher Exact|||||||0.779
74067241|NCT00408876|147686524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.747||95.0|-1.47|1.06|||t-test, 2 sided|||||1.06|-1.47|0.747
74067242|NCT00408876|147686524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07||||0.045||95.0|-2.12|-0.02|||t-test, 2 sided|||||-0.02|-2.12|0.045
74067243|NCT00408876|147686524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.58||95.0|-0.76|1.36|||t-test, 2 sided|||||1.36|-0.76|0.580
74067244|NCT00408876|147686524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86||||0.185||95.0|-2.14|0.41|||t-test, 2 sided|||||0.41|-2.14|0.185
74067245|NCT00408876|147686524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.438||95.0|-0.77|1.79|||t-test, 2 sided|||||1.79|-0.77|0.438
74067246|NCT00408876|147686524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37||||0.012||95.0|0.3|2.44|||t-test, 2 sided|||||2.44|0.30|0.012
74067247|NCT00408876|147686525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46||||0.729||95.0|-2.16|3.08|||t-test, 2 sided|||||3.08|-2.16|0.729
74067248|NCT00408876|147686525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02||||0.352||95.0|-1.14|3.18|||t-test, 2 sided|||||3.18|-1.14|0.352
74067249|NCT00408876|147686525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.465||95.0|-3.0|1.37|||t-test, 2 sided|||||1.37|-3.00|0.465
74067250|NCT00408876|147686525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.677||95.0|-2.09|3.21|||t-test, 2 sided|||||3.21|-2.09|0.677
74067251|NCT00408876|147686525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.27||||0.345||95.0|-3.92|1.38|||t-test, 2 sided|||||1.38|-3.92|0.345
74067252|NCT00408876|147686525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.84||||0.102||95.0|-4.04|0.37|||t-test, 2 sided|||||0.37|-4.04|0.102
74067253|NCT00408876|147686526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.977||95.0|-2.91|2.83|||t-test, 2 sided|||||2.83|-2.91|0.977
74067254|NCT00408876|147686526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.451||95.0|-1.44|3.24|||t-test, 2 sided|||||3.24|-1.44|0.451
74067255|NCT00408876|147686526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.74||||0.15||95.0|-0.63|4.11|||t-test, 2 sided|||||4.11|-0.63|0.150
74067256|NCT00408876|147686526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94||||0.524||95.0|-1.96|3.83|||t-test, 2 sided|||||3.83|-1.96|0.524
74067257|NCT00408876|147686526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.78||||0.23||95.0|-1.13|4.69|||t-test, 2 sided|||||4.69|-1.13|0.230
74067258|NCT00408876|147686526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84||||0.491||95.0|-1.55|3.23|||t-test, 2 sided|||||3.23|-1.55|0.491
74067259|NCT00408876|147686527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.645||95.0|-0.49|0.79|||t-test, 2 sided|||||0.79|-0.49|0.645
74067260|NCT00408876|147686527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.027||95.0|0.07|1.12|||t-test, 2 sided|||||1.12|0.07|0.027
74067261|NCT00408876|147686527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.006||95.0|0.22|1.29|||t-test, 2 sided|||||1.29|0.22|0.006
74067262|NCT00408876|147686527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44||||0.18||95.0|-0.21|1.1|||t-test, 2 sided|||||1.10|-0.21|0.180
73883348|NCT02212015|147300738|SUPERIORITY|||||||0.349|||||||Chi squared test, exact|||Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies. Categories of BOR are CR, PR, SD, PD and NE)|Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies applied to the total of 26 enrolled subjects.. Categories of BOR are CR, PR, SD, PD and NE).|||0.349
74067263|NCT00408876|147686527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.069||95.0|-0.05|1.25|||t-test, 2 sided|||||1.25|-0.05|0.069
74067264|NCT00408876|147686527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.564||95.0|-0.38|0.7|||t-test, 2 sided|||||0.70|-0.38|0.564
74067265|NCT00408876|147686528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.929||95.0|-0.92|1.0|||t-test, 2 sided|||||1.00|-0.92|0.929
74067266|NCT00408876|147686528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.147||95.0|-0.21|1.36|||t-test, 2 sided|||||1.36|-0.21|0.147
74067267|NCT00408876|147686528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.7||95.0|-0.64|0.95|||t-test, 2 sided|||||0.95|-0.64|0.700
74067268|NCT00408876|147686528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.279||95.0|-0.44|1.51|||t-test, 2 sided|||||1.51|-0.44|0.279
74067269|NCT00408876|147686528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.822||95.0|-0.86|1.09|||t-test, 2 sided|||||1.09|-0.86|0.822
74067270|NCT00408876|147686528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.299||95.0|-1.22|0.38|||t-test, 2 sided|||||0.38|-1.22|0.299
74067271|NCT00408876|147686529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.766||95.0|-1.33|0.98|||t-test, 2 sided|||||0.98|-1.33|0.766
74067272|NCT00408876|147686529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.217||95.0|-0.35|1.55|||t-test, 2 sided|||||1.55|-0.35|0.217
74067273|NCT00408876|147686529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.88||95.0|-0.89|1.04|||t-test, 2 sided|||||1.04|-0.89|0.880
74067274|NCT00408876|147686529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78||||0.193||95.0|-0.39|1.94|||t-test, 2 sided|||||1.94|-0.39|0.193
73883349|NCT02212015|147300739|SUPERIORITY|||||||0.385|||||||Chi squared test, exact|||||||0.385
74067275|NCT00408876|147686529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.675||95.0|-0.92|1.42|||t-test, 2 sided|||||1.42|-0.92|0.675
74067276|NCT00408876|147686529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.288||95.0|-1.5|0.45|||t-test, 2 sided|||||0.45|-1.50|0.288
74067277|NCT00408876|147686530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.501||95.0|-1.66|0.81|||t-test, 2 sided|||||0.81|-1.66|0.501
74067278|NCT00408876|147686530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.524||95.0|-0.69|1.35|||t-test, 2 sided|||||1.35|-0.69|0.524
74067279|NCT00408876|147686530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.089||95.0|-0.14|1.91|||t-test, 2 sided|||||1.91|-0.14|0.089
74067280|NCT00408876|147686530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.234||95.0|-0.49|2.0|||t-test, 2 sided|||||2.00|-0.49|0.234
74067281|NCT00408876|147686530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.31||||0.04||95.0|0.06|2.56|||t-test, 2 sided|||||2.56|0.06|0.040
74067282|NCT00408876|147686530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.289||95.0|-0.48|1.59|||t-test, 2 sided|||||1.59|-0.48|0.289
74067283|NCT00408876|147686531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.862||95.0|-0.27|0.32|||t-test, 2 sided|||||0.32|-0.27|0.862
74067284|NCT00408876|147686531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.368||95.0|-0.13|0.35|||t-test, 2 sided|||||0.35|-0.13|0.368
74067285|NCT00408876|147686531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.628||95.0|-0.18|0.31|||t-test, 2 sided|||||0.31|-0.18|0.628
74067286|NCT00408876|147686531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.573||95.0|-0.21|0.38|||t-test, 2 sided|||||0.38|-0.21|0.573
74067287|NCT00408876|147686531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.819||95.0|-0.26|0.33|||t-test, 2 sided|||||0.33|-0.26|0.819
74067288|NCT00408876|147686531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.687||95.0|-0.3|0.2|||t-test, 2 sided|||||0.20|-0.30|0.687
74067289|NCT00408876|147686532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.972||95.0|-0.48|0.5|||t-test, 2 sided|||||0.50|-0.48|0.972
74067290|NCT00408876|147686532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.99||95.0|-0.4|0.4|||t-test, 2 sided|||||0.40|-0.40|0.990
74067291|NCT00408876|147686532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.793||95.0|-0.35|0.46|||t-test, 2 sided|||||0.46|-0.35|0.793
74067292|NCT00408876|147686532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.981||95.0|-0.5|0.49|||t-test, 2 sided|||||0.49|-0.50|0.981
74067293|NCT00408876|147686532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.857||95.0|-0.45|0.54|||t-test, 2 sided|||||0.54|-0.45|0.857
73883350|NCT03448406|147300741|SUPERIORITY||Median difference (HL-estimate)|4.0||||0.366|TWO_SIDED|95.0|-5.0|13.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||13.0|-5.0|0.3660
74067294|NCT00408876|147686532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.805||95.0|-0.36|0.46|||t-test, 2 sided|||||0.46|-0.36|0.805
74067295|NCT00408876|147686533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.34||95.0|-0.26|0.75|||t-test, 2 sided|||||0.75|-0.26|0.340
74067296|NCT00408876|147686533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.848||95.0|-0.45|0.37|||t-test, 2 sided|||||0.37|-0.45|0.848
74067297|NCT00408876|147686533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.573||95.0|-0.54|0.3|||t-test, 2 sided|||||0.30|-0.54|0.573
74067298|NCT00408876|147686533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.272||95.0|-0.79|0.22|||t-test, 2 sided|||||0.22|-0.79|0.272
74067299|NCT00408876|147686533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.161||95.0|-0.88|0.15|||t-test, 2 sided|||||0.15|-0.88|0.161
74067300|NCT00408876|147686533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.711||95.0|-0.5|0.34|||t-test, 2 sided|||||0.34|-0.50|0.711
74067301|NCT00408876|147686534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.713||95.0|-1.39|0.95|||t-test, 2 sided|||||0.95|-1.39|0.713
74067302|NCT00408876|147686534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52||||0.288||95.0|-0.44|1.49|||t-test, 2 sided|||||1.49|-0.44|0.288
73888305|NCT01746901|147309548|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0008|TWO_SIDED|95.0|1.1|4.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.3|1.1|0.0008
74067303|NCT00408876|147686534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.351||95.0|-1.44|0.51|||t-test, 2 sided|||||0.51|-1.44|0.351
74067304|NCT00408876|147686534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.219||95.0|-0.44|1.93|||t-test, 2 sided|||||1.93|-0.44|0.219
74067305|NCT00408876|147686534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.686||95.0|-1.43|0.94|||t-test, 2 sided|||||0.94|-1.43|0.686
74067306|NCT00408876|147686534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.98||||0.05||95.0|-1.97|0.0|||t-test, 2 sided|||||0.00|-1.97|0.050
74067307|NCT00408876|147686535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.663||95.0|-0.06|0.04|||t-test, 2 sided|||||0.04|-0.06|0.663
74067308|NCT00408876|147686535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.33||95.0|-0.02|0.06|||t-test, 2 sided|||||0.06|-0.02|0.330
74067309|NCT00408876|147686535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.143||95.0|-0.01|0.07|||t-test, 2 sided|||||0.07|-0.01|0.143
74067310|NCT00408876|147686535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.218||95.0|-0.02|0.08|||t-test, 2 sided|||||0.08|-0.02|0.218
74067311|NCT00408876|147686535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.1||95.0|-0.01|0.09|||t-test, 2 sided|||||0.09|-0.01|0.100
74067312|NCT00408876|147686535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.614||95.0|-0.03|0.05|||t-test, 2 sided|||||0.05|-0.03|0.614
74067313|NCT00408876|147686536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.786||95.0|-1.83|1.39|||t-test, 2 sided|||||1.39|-1.83|0.786
74067314|NCT00408876|147686536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.445||95.0|-1.85|0.81|||t-test, 2 sided|||||0.81|-1.85|0.445
74067315|NCT00408876|147686536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.39||||0.043||95.0|0.04|2.74|||t-test, 2 sided|||||2.74|0.04|0.043
74067316|NCT00408876|147686536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.721||95.0|-1.92|1.33|||t-test, 2 sided|||||1.33|-1.92|0.721
74067317|NCT00408876|147686536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.61||||0.053||95.0|-0.02|3.24|||t-test, 2 sided|||||3.24|-0.02|0.053
74067318|NCT00408876|147686536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.91||||0.006||95.0|0.54|3.27|||t-test, 2 sided|||||3.27|0.54|0.006
74067319|NCT00408876|147686537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.378||95.0|-0.48|1.25|||t-test, 2 sided|||||1.25|-0.48|0.378
74067320|NCT00408876|147686537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.723||95.0|-0.84|0.59|||t-test, 2 sided|||||0.59|-0.84|0.723
74067321|NCT00408876|147686537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.542||95.0|-0.95|0.5|||t-test, 2 sided|||||0.50|-0.95|0.542
74067322|NCT00408876|147686537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.245||95.0|-1.39|0.36|||t-test, 2 sided|||||0.36|-1.39|0.245
74067323|NCT00408876|147686537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.169||95.0|-1.48|0.26|||t-test, 2 sided|||||0.26|-1.48|0.169
74067324|NCT00408876|147686537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.796||95.0|-0.82|0.63|||t-test, 2 sided|||||0.63|-0.82|0.796
74067325|NCT00408876|147686539|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74067326|NCT00408876|147686539|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
74067327|NCT00408876|147686539|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
74067328|NCT00408876|147686540|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||t-test, 2 sided|||||||0.039
74067329|NCT00408876|147686541|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||t-test, 2 sided|||||||0.048
74067330|NCT00408876|147686542|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
74067331|NCT00408876|147686542|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||t-test, 2 sided|||||||0.046
74067332|NCT00408876|147686543|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||t-test, 2 sided|||||||0.039
74067333|NCT00408876|147686544|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||||||0.042
74067334|NCT00408876|147686545|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74067335|NCT00408876|147686546|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||t-test, 2 sided|||||||0.031
74067336|NCT00408876|147686547|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||||||0.030
74067337|NCT00408876|147686548|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
74067338|NCT00408876|147686548|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74067339|NCT00408876|147686548|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
74067340|NCT00408876|147686549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.38||||0.348||95.0|-4.28|1.51|||t-test, 2 sided|||||1.51|-4.28|0.348
74067341|NCT00408876|147686549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.04||95.0|0.11|4.89|||t-test, 2 sided|||||4.89|0.11|0.040
73883351|NCT03448406|147300742|SUPERIORITY||Median difference (HL-estimate)|2.08||||0.2783|TWO_SIDED|95.0|-2.08|6.25|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||6.25|-2.08|0.2783
74067342|NCT00408876|147686549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.61||||0.191||95.0|-0.81|4.03|||t-test, 2 sided|||||4.03|-0.81|0.191
74067343|NCT00408876|147686549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.89||||0.009||95.0|0.97|6.8|||t-test, 2 sided|||||6.80|0.97|0.009
74067344|NCT00408876|147686549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0||||0.044||95.0|0.08|5.91|||t-test, 2 sided|||||5.91|0.08|0.044
74067345|NCT00408876|147686549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89||||0.473||95.0|-3.33|1.55|||t-test, 2 sided|||||1.55|-3.33|0.473
73888306|NCT01746901|147309548|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.645|TWO_SIDED|95.0|-2.0|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-2.0|0.6450
74067346|NCT00408876|147686550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.846||95.0|-3.61|4.4|||t-test, 2 sided|||||4.40|-3.61|0.846
74067347|NCT00408876|147686550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.934||95.0|-3.45|3.17|||t-test, 2 sided|||||3.17|-3.45|0.934
74067348|NCT00408876|147686550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.03||||0.234||95.0|-1.32|5.39|||t-test, 2 sided|||||5.39|-1.32|0.234
74067349|NCT00408876|147686550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.794||95.0|-4.58|3.5|||t-test, 2 sided|||||3.50|-4.58|0.794
74067350|NCT00408876|147686550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.64||||0.426||95.0|-2.4|5.67|||t-test, 2 sided|||||5.67|-2.40|0.426
74067351|NCT00408876|147686550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.17||||0.207||95.0|-1.21|5.55|||t-test, 2 sided|||||5.55|-1.21|0.207
74067352|NCT00408876|147686551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.901||95.0|-2.54|2.89|||t-test, 2 sided|||||2.89|-2.54|0.901
74067353|NCT00408876|147686551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.926||95.0|-2.35|2.14|||t-test, 2 sided|||||2.14|-2.35|0.926
74067354|NCT00408876|147686551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.62||||0.002||95.0|1.35|5.9|||t-test, 2 sided|||||5.90|1.35|0.002
74067355|NCT00408876|147686551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.841||95.0|-3.02|2.46|||t-test, 2 sided|||||2.46|-3.02|0.841
74067356|NCT00408876|147686551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.45||||0.014||95.0|0.71|6.19|||t-test, 2 sided|||||6.19|0.71|0.014
74067357|NCT00408876|147686551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.73||||0.001||95.0|1.44|6.02|||t-test, 2 sided|||||6.02|1.44|0.001
74067358|NCT00408876|147686552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.057||95.0|-1.41|0.02|||t-test, 2 sided|||||0.02|-1.41|0.057
74067359|NCT00408876|147686552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.128||95.0|-1.05|0.13|||t-test, 2 sided|||||0.13|-1.05|0.128
74067360|NCT00408876|147686552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.82||||0.007||95.0|-1.42|-0.22|||t-test, 2 sided|||||-0.22|-1.42|0.007
74067361|NCT00408876|147686552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.518||95.0|-0.48|0.96|||t-test, 2 sided|||||0.96|-0.48|0.518
74067362|NCT00408876|147686552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.734||95.0|-0.85|0.6|||t-test, 2 sided|||||0.60|-0.85|0.734
74067363|NCT00408876|147686552|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.239||95.0|-0.97|0.24|||t-test, 2 sided|||||0.24|-0.97|0.239
74067364|NCT03558997|147686596|SUPERIORITY||Least Square (LS) Mean Difference|4.73||||0.7185|TWO_SIDED|95.0|-21.023|30.487|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||30.487|-21.023|0.7185
74067365|NCT03558997|147686597|SUPERIORITY||Least Square (LS) Mean Difference|0.3||||0.5438|TWO_SIDED|95.0|-0.661|1.254|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||1.254|-0.661|0.5438
74067366|NCT03558997|147686598|SUPERIORITY||Least Square (LS) Mean Difference|0.03||||0.9559|TWO_SIDED|95.0|-0.877|0.928|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||0.928|-0.877|0.9559
73883352|NCT03448406|147300743|SUPERIORITY||Median difference (HL-estimate)|-0.07||||0.5512|TWO_SIDED|95.0|-0.35|0.2|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||0.20|-0.35|0.5512
73883353|NCT03448406|147300744|SUPERIORITY||Median Difference (HL-estimate)|3.0||||0.3657|TWO_SIDED|95.0|-4.0|11.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||11.0|-4.0|0.3657
74067367|NCT03558997|147686599|SUPERIORITY||Least Square (LS) Mean Difference|7.25||||0.5416|TWO_SIDED|95.0|-16.028|30.53|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||30.530|-16.028|0.5416
74067368|NCT03558997|147686600|SUPERIORITY||Least Square (LS) Mean Difference|-0.94||||0.0414|TWO_SIDED|95.0|-1.848|-0.037|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-0.037|-1.848|0.0414
74067369|NCT03558997|147686601|SUPERIORITY||Least Square (LS) Mean Difference|-30.45||||0.0108|TWO_SIDED|95.0|-53.874|-7.034|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-7.034|-53.874|0.0108
74067370|NCT03558997|147686602|SUPERIORITY||Median Difference|0.665||||0.1449|TWO_SIDED|95.0|-0.77|3.21|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||3.2100|-0.770|0.1449
74067371|NCT03558997|147686603|SUPERIORITY||Median Difference|335.3||||0.1231|TWO_SIDED|95.0|-551.47|1746.55|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||1746.55|-551.47|0.1231
74067372|NCT03558997|147686604|SUPERIORITY||Median Difference|-13.325|||<|0.0001|TWO_SIDED|95.0|-23.94|-8.36|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||-8.3600|-23.9400|<0.0001
74067373|NCT03558997|147686605|SUPERIORITY||Median Difference|-134.6|||<|0.0001|TWO_SIDED|95.0|-205.51|-94.98|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||-94.98|-205.51|<0.0001
74067374|NCT03558997|147686606|SUPERIORITY||Median Difference|0.84|||<|0.0001|TWO_SIDED|95.0|0.45|1.27|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||1.2700|0.4500|<0.0001
74067375|NCT02033876|147686608|SUPERIORITY|||||||0.43|||||||ANCOVA|||||||0.43
74067376|NCT02033876|147686609|SUPERIORITY|||||||0.65|||||||ANCOVA|||||||0.65
74067377|NCT02033876|147686611|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
74067378|NCT02033876|147686612|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
74067379|NCT02033876|147686613|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||0.4
74067380|NCT02033876|147686614|SUPERIORITY|||||||0.8|||||||ANCOVA|||||||0.8
74067381|NCT02033876|147686615|SUPERIORITY|||||||0.006|||||||ANCOVA|||||||0.006
74067382|NCT00803959|147686644|NON_INFERIORITY_OR_EQUIVALENCE|The investigators selected the 11% noninferiority margin on the basis of clinical judgement that it was a reasonable threshold for a trade-off between a decrease in the rate of successful treatment and the potential benefits of eliminating UDS studies from preoperative assessment. To minimize bias toward noninferiority, only women treated per protocol (e.g. who underwent the randomly assigned evaluation) were considered in the primary outcome analysis (ITT analysis considered secondary).|Difference in success % (UDS - no UDS)|-0.3|||||TWO_SIDED|95.0|-7.5|6.9|||Chi-squared|Noninferiority declared if the upper boundary of the two-sided 95% confidence interval for the difference in % success (UDS - no UDS) was \< 11%.|Point estimates of success percentage are calculated as 200/259= 77.2% for Office Evaluation Only and 203/264 = 76.9% for Urodynamic Testing arm.|The null hypothesis was that the no UDS group was non-inferior to those in the UDS group. Assuming a significance level of 5% and a true success rate in each group of 70% with a noninferiority margin of 11 percentage points, we needed to enroll 270 women/group to have 80% power for determining whether the results in the no UDS group were non inferior to those in the UDS group. Assuming a 10% dropout rate, a sample of 300 women per group was required.||6.9|-7.5|
74067383|NCT00803959|147686645|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||The p-value is not adjusted for multiple comparisons. Alpha level is considered to be 0.05.|Chi-squared|No adjustments were made; test had 1 degree of freedom.||Null hypothesis is that the two groups will not differ in the percent meeting 70% reduction in Urogenital Distress Inventory score.||||0.63
74067384|NCT00803959|147686646|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|Chi-squared|No adjustments made; 1 degree of freedom test.||"Null hypothesis is that there is no difference in the proportion responding very much better or much better on the Patient Global Impression of Improvement at the 12 month visit."||||0.68
74067385|NCT00803959|147686647|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||P-value is not adjusted for multiple comparisons; a priori threshold for statistical significance was set at alpha = 0.05.|t-test, 2 sided|One df t test assumed equal variance; no evidence was found to the contrary.||Null hypothesis is that the two arms do not differ according to change in UDI score.||||0.68
74067386|NCT00803959|147686648|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||P-value was not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|Test was 1 df t-test assuming equal variances; no evidence to the contrary was found.||Null hypothesis is that the 2 arms do not differ according to change in ISI score.||||0.40
74067387|NCT00803959|147686649|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||P-value not adjusted for multiple comparisons; a priori threshold was alpha = 0.05.|t-test, 2 sided|The t test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ in change in MESA stress score.||||0.50
74067388|NCT00803959|147686650|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|The t test had 1 df and assumed equal variances; no evidence of different variances was found.||Null hypothesis is that the two arms do not differ according to change in MESA urgency score.||||0.19
74067389|NCT00803959|147686651|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05|t-test, 2 sided|T test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in IIQ score.||||0.49
74067390|NCT00803959|147686652|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|T test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in SF-12 scores.||||0.02
74067391|NCT00803959|147686653|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|The t test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in PGI-S score.||||0.51
74067392|NCT00803959|147686654|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the 2 arms do not differ in the proportion of women who score moderate or severe on the PGI-S at 12 months||||0.51
74067393|NCT00803959|147686655|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was alpha = 0.05.|t-test, 2 sided|T test had 1 df and assumed equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean overall patient satisfaction score at 12 months.||||0.28
74067394|NCT00803959|147686656|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-values was not adjusted for multiple comparisons and the a priori threshold for statistical significance was set at alpha = 0.05.|Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the proportion having a positive provocative stress test at 12 months was the same in both treatment arms.||||0.19
74067395|NCT02410252|147686659|OTHER||%|100.0|||||TWO_SIDED|||||There was no statistical analysis conducted on demographic characteristics or baseline surveys|descriptive analysis|||Descriptive statistics were used to characterize the study sample, and survey responses.||||
74067396|NCT02410252|147686659|OTHER|Only percents were calculated, no formal statistical analysis was completed.||||||||||||Statistical analysis was not completed. This was a feasibility study with small n and was not powered to determine statistical significance.||||Only percent will be calculated. No statistical analysis will be conducted.|No statistical analysis was conducted as part of this study.|||
74067397|NCT02410252|147686660|OTHER||%|0.29||||0.13|TWO_SIDED|||||Significance was set at p\<0.05|Cochran-Mantel-Haenszel|||"GAD-7 scores were coded as a categorical variable as follows: mild anxiety (total score 0 to 5) and moderate/ severe anxiety (total score 6-15).~Proportion of participants with mild and moderate/ severe anxiety at enrollment and closeout was compared using Cochran's Q test."||||0.13
74067398|NCT02410252|147686661|OTHER||%|84.0||||0.05|TWO_SIDED||||||descriptive analysis|||Descriptive statistics were used to characterize the study sample, and survey responses. All analysis was conducted using STATA version 14.2 with an alpha of 0.05 set a priori. Since this was an exploratory study with descriptive statistics, a complete case analysis approach was adopted for this study||||0.05
74067399|NCT00387712|147686663|OTHER|Analysis of variance between groups across time is the primary analyses.||||||0.001||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the primary outcome category (peak fitness) using repeated measures analysis of variance. No adjustment for multiple comparisons is needed.|ANOVA|No other adjustments such as degrees of freedom was necessary.||"Power Calculation: It was calculated that 29 subjects should be randomized to 2 groups to achieve a significant time by group interaction for peak fitness for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.~Primary analyses is a group by time analysis of variance in peak fitness levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points."||||0.001
73883354|NCT03448406|147300745|OTHER||Difference of adjusted mean|-0.09|STANDARD_DEVIATION|0.11||0.444|TWO_SIDED|95.0|-0.31|0.14|||Mixed Model Repeated Measure (MMRM)|Covariates: visit-by-treatment interaction, baseline-by-visit interaction. Unstructured covariance structure was used to model within-patient errors.||||0.14|-0.31|0.4440
73883355|NCT03448406|147300746|OTHER|||||||0.3924|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.3924
73883356|NCT03448406|147300747|OTHER|||||||0.4435|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.4435
73883357|NCT03448406|147300748|OTHER|||||||0.5124|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5124
73883358|NCT03448406|147300749|OTHER|||||||0.5713|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5713
73883359|NCT03448406|147300750|OTHER||Adjusted geometric mean ratio|0.95||||0.4032|TWO_SIDED|95.0|0.85|1.07|||Mixed model repeated Measure (MMRM)|Covariates: Visit-by-treatment interaction and baseline-by-visit interaction. Unstructured covariance structure to model within-patient errors.|Adjusted geometric mean ratio \[Empagliflozin/Placebo\] of relative change to baseline.|||1.07|0.85|0.4032
73883360|NCT04369404|147300751|SUPERIORITY|We hypothesize that participants who received the decision aid will have higher knowledge. This is pilot study, thus we did not have a power calculation.|Mean Difference (Final Values)|12.0||||0.06|TWO_SIDED|95.0|0.7|24.6|||t-test, 2 sided|||||24.6|0.7|0.06
73883361|NCT04369404|147300752|OTHER||Pearson Chi-Square|2.97||||0.085|TWO_SIDED||||||Chi-squared|||"a chisquare test was conducted to determine if the proportion of treatment unsure responses were different between the usual care and intervention arms."||||0.085
74067400|NCT00387712|147686664|OTHER|Primary analyses is a group by time analysis of variance in myosin heavy chain levels levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.||||||0.11|||||||ANOVA|||Power Calculation: It was calculated that 22 participants should be randomized to 2 groups to achieve a significant time by group interaction for myosin heavy chain isoforms for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.||||0.11
74067401|NCT00387712|147686665|OTHER|Analysis of variance between groups across time is the primary analyses.||||||0.81||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the secondary outcome category (30 ft walk time - fastest comfortable gait) using repeated measures analysis of variance.|ANOVA|No other adjustments such as degrees of freedom was necessary.||Primary analyses is a group by time analysis of variance in 30 foot walk time (sec) between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.||||0.81
74067402|NCT00322309|147686666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|2.6|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||It was hypothesized that there would be no significant difference between the two treatment groups for benzoylecgonine data collected for Week 11.||||>0.05
74067403|NCT00322309|147686667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|6.6|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||It was hypothesized that means scores for the CGI-O would not differ significantly for these values obtained in the final treatment week, Week 11.||||>0.05
74067404|NCT00322309|147686668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.4|>|0.05|TWO_SIDED|||||This analysis involves a between group comparison.|t-test, 2 sided|||It hypothesized that the two treatment groups would not differ significantly with respect to the total HAM-D scores obtained in the final week of the study (Week 11).||||>0.05
73883362|NCT04369404|147300753|OTHER||Pearson Chi-Square|1.524||||0.47|TWO_SIDED||||||Chi-squared|||||||0.47
74067405|NCT00322309|147686669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|18.0|>|0.05||95.0||||Percent of capsules administered does not differ significantly between the two groups.|t-test, 2 sided|||It was hypothesized that there would be no significant difference in the mean percentage of capsules of those dispensed between the two groups.||||>0.05
74067406|NCT00322309|147686670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|8.5|>|0.05||95.0|||||t-test, 2 sided|||It was hypothesized that there would not be a significant difference between the two groups in the mean percent of urines positive for riboflavin.||||>0.05
73883363|NCT02542865|147300762|SUPERIORITY||Mean Difference (Net)|-6.0|STANDARD_ERROR_OF_MEAN|1.56||0.0628|TWO_SIDED|95.0|-12.7|0.8|||ANCOVA|Analysis of variance(ANCOVA):cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group (fortified malt based food plus dietary counselling) minus Control Group (dietary counselling only).|||0.8|-12.7|0.0628
73883364|NCT02542865|147300762|SUPERIORITY||Mean Difference (Net)|-4.9||||0.039|||||||ANCOVA|ANCOVA:cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group minus Control Group. The corresponding CI is not presented as there is no direct back-transformation.|Since the distribution of the data was found to be more skewed with more zero counts than was anticipated at the time the trial was designed, an additional analysis of log (+1)-transformed data was performed.||||0.0390
74067407|NCT01772368|147686677|OTHER|linearity statistical test|||||<|0.0001||||||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.||A linear in log-dose-trend contrast was constructed to evaluate the dose-response trend, where the logarithm of dose was defined precisely as log (dose+1) to accommodate the case of Fp MDPI 100 mcg, since the dose used in this trend analysis was the salmeterol dose. The study was considered positive if the trend test was positive and the test involving the highest FS MDPI dose (100/50 mcg) compared with Fp MDPI 100 mcg was positive, regardless of the results of the tests for the other doses.||||<0.0001
74067408|NCT01772368|147686677|SUPERIORITY||LSM difference|251.3|||<|0.0001|TWO_SIDED|95.0|215.6|287.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||287.1|215.6|<0.0001
74067409|NCT01772368|147686677|SUPERIORITY||LSM difference|227.56|||<|0.0001|TWO_SIDED|95.0|191.6|263.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||263.5|191.6|<0.0001
74067410|NCT01772368|147686677|SUPERIORITY||LSM difference|196.85|||<|0.0001|TWO_SIDED|95.0|161.2|232.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/512.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||232.5|161.2|<0.0001
74067411|NCT01772368|147686677|SUPERIORITY||LSM difference|151.71|||<|0.0001|TWO_SIDED|95.0|115.9|187.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||187.5|115.9|<0.0001
74067412|NCT01772368|147686677|SUPERIORITY||LSM difference|193.42|||<|0.0001|TWO_SIDED|95.0|157.4|229.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100|The estimated treatment difference from the ANCOVA model between Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||229.5|157.4|<0.0001
74067413|NCT01772368|147686677|SUPERIORITY||LSM difference|57.88||||0.0017|TWO_SIDED|95.0|22.0|93.7||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||93.7|22.0|0.0017
74067414|NCT01772368|147686677|SUPERIORITY||LSM difference|34.14||||0.0624|TWO_SIDED|95.0|-1.8|70.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||70.1|-1.8|0.0624
74067415|NCT01772368|147686677|SUPERIORITY||LSM difference|3.42||||0.8503|TWO_SIDED|95.0|-32.3|39.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||39.1|-32.3|0.8503
74067416|NCT01772368|147686677|SUPERIORITY||LSM difference|-41.72||||0.0229|TWO_SIDED|95.0|-77.6|-5.8||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-5.8|-77.6|0.0229
73883365|NCT02005016|147300782|OTHER|This was a single-group study. A t-test was administered comparing pre- and post-treatment PNT scores (range: 1-175; higher scores are better).|||||<|0.005|||||||t-test, 1 sided|||||||<0.005
74067417|NCT01772368|147686677|SUPERIORITY||LSM difference|-193.42|||<|0.0001|TWO_SIDED|95.0|-229.5|-157.4||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-157.4|-229.5|<0.0001
74067418|NCT01772368|147686678|SUPERIORITY||LSM difference|226.77|||<|0.0001|TWO_SIDED|95.0|172.4|281.1||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||281.1|172.4|<0.0001
74067419|NCT01772368|147686678|SUPERIORITY||LSM difference|198.32|||<|0.0001|TWO_SIDED|95.0|143.7|252.9||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||252.9|143.7|<0.0001
74067420|NCT01772368|147686678|SUPERIORITY||LSM difference|158.99|||<|0.0001|TWO_SIDED|95.0|104.7|213.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||213.3|104.7|<0.0001
73883366|NCT02005016|147300783|OTHER|This was a single-group study. A t-test was administered comparing pre- and post-treatment CAT modality mean T-scores (range: 30-70, mean: 50; higher scores are better).|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
74067421|NCT01772368|147686678|SUPERIORITY||LSM difference|116.96|||<|0.0001|TWO_SIDED|95.0|62.4|171.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||171.6|62.4|<0.0001
73888307|NCT01746901|147309548|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.0962|TWO_SIDED|95.0|-0.2|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-0.2|0.0962
74067422|NCT01772368|147686678|SUPERIORITY||LSM difference|159.01|||<|0.0001|TWO_SIDED|95.0|104.3|213.7||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||213.7|104.3|<0.0001
74067423|NCT01772368|147686678|SUPERIORITY||LSM difference|67.76||||0.015|TWO_SIDED|95.0|13.3|122.2||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||122.2|13.3|0.0150
74067424|NCT01772368|147686678|SUPERIORITY||LSM difference|39.31||||0.1578|TWO_SIDED|95.0|-15.3|94.0||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||94.0|-15.3|0.1578
74067425|NCT01772368|147686678|SUPERIORITY||LSM difference|-0.02||||0.9993|TWO_SIDED|95.0|-54.4|54.4||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||54.4|-54.4|0.9993
74067426|NCT01772368|147686678|SUPERIORITY||LSM difference|-42.05||||0.1311|TWO_SIDED|95.0|-96.7|12.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||12.6|-96.7|0.1311
74067427|NCT01772368|147686678|SUPERIORITY||LSM difference|-159.01|||<|0.0001|TWO_SIDED|95.0|-213.7|-104.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-104.3|-213.7|<0.0001
74067428|NCT01772368|147686679|SUPERIORITY||geometric mean ratio|1.929|||||TWO_SIDED|90.0|1.69|2.202||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58||2.202|1.690|
74067429|NCT01772368|147686679|SUPERIORITY||geometric mean ratio|0.8|||||TWO_SIDED|90.0|0.702|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.911|0.702|
74067430|NCT01772368|147686679|SUPERIORITY||geometric mean ratio|0.427|||||TWO_SIDED|90.0|0.376|0.485||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61||0.485|0.376|
74067431|NCT01772368|147686679|SUPERIORITY||LSM difference|0.172|||||TWO_SIDED|90.0|0.151|0.196||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.196|0.151|
74067432|NCT01772368|147686680|SUPERIORITY||geometric mean ratio|3.622|||||TWO_SIDED|90.0|3.149|4.168||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58||4.168|3.149|
74067433|NCT01772368|147686680|SUPERIORITY||geometric mean ratio|1.534|||||TWO_SIDED|90.0|1.335|1.763||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||1.763|1.335|
74067434|NCT01772368|147686680|SUPERIORITY||geometric mean ratio|0.795|||||TWO_SIDED|90.0|0.694|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61||0.911|0.694|
74067435|NCT01772368|147686680|SUPERIORITY||geometric mean ratio|0.339|||||TWO_SIDED|90.0|0.295|0.39||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.390|0.295|
74067436|NCT02449291|147686688|SUPERIORITY|||||||0.016|ONE_SIDED|95.0||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.016) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.016
74067437|NCT02449291|147686688|SUPERIORITY|||||||0.016||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.015) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.016
74067438|NCT02449291|147686689|SUPERIORITY|||||||0.009||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.009
74067439|NCT02449291|147686689|SUPERIORITY|||||||0.002||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.002
74067440|NCT02449291|147686690|SUPERIORITY|||||||0.17||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.170
74067441|NCT02449291|147686690|SUPERIORITY|||||||0.552||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.552
74067442|NCT02449291|147686691|SUPERIORITY|||||||0.003|||||||Regression, Cox|||||||0.003
74067443|NCT02449291|147686691|SUPERIORITY||||||<|0.001|||||||Regression, Cox|||||||<0.001
74067444|NCT02449291|147686692|SUPERIORITY|||||||0.209|||||||Chi-squared|||||||0.209
73883367|NCT00083889|147300784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5268|||<|0.0001|TWO_SIDED|95.0|0.4316|0.643||p-value from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio les than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α). Progression-free survival (PFS) was assessed in each treatment arm using the Kaplan-Meier method.||0.6430|0.4316|<0.0001
74067445|NCT02449291|147686692|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.440
74067446|NCT02449291|147686693|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
74067447|NCT02449291|147686693|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
74067448|NCT02449291|147686694|SUPERIORITY|||||||0.115|||||||Chi-squared|||||||0.115
74067449|NCT02449291|147686694|SUPERIORITY|||||||0.222|||||||Chi-squared|||||||0.222
74067450|NCT02449291|147686695|SUPERIORITY|||||||0.474|||||||Chi-squared|||||||0.474
74067451|NCT02449291|147686695|SUPERIORITY|||||||0.505|||||||Chi-squared|||||||0.505
74067452|NCT02449291|147686696|SUPERIORITY|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||||||0.103
74067453|NCT02449291|147686696|SUPERIORITY|||||||0.166|||||||Wilcoxon (Mann-Whitney)|||||||0.166
74067454|NCT02449291|147686697|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
74067455|NCT02449291|147686697|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
74067456|NCT02363010|147686698|SUPERIORITY|||||||0.68||||||A prior threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline weight.||Exploring group differences in 12 month weight losses.||||.68
74067457|NCT02363010|147686698|SUPERIORITY|||||||0.11||||||A prior threshold for significance was p\<.05.|ANOVA|Controlling for baseline weight.||Exploring group differences in 18 month weight losses.||||.11
74067458|NCT02363010|147686699|SUPERIORITY|||||||0.41||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month moderator to vigorous physical activity (MVPA).||||.41
74067459|NCT02363010|147686699|SUPERIORITY|||||||0.46||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month MVPA.||||.46
74067460|NCT02363010|147686699|SUPERIORITY|||||||0.82||||||A priori threshold for statistical significance was p\< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month MVPA.||||.82
74067461|NCT02363010|147686699|SUPERIORITY|||||||0.42||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.42
74067462|NCT02363010|147686699|SUPERIORITY|||||||0.28||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.28
74067463|NCT02363010|147686699|SUPERIORITY|||||||0.82||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.82
74067464|NCT02363010|147686700|SUPERIORITY|||||||0.06||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline half-mile walk time.||Exploring group differences in 12 month cardiorespiratory fitness, measured by half-mile walk time.||||.06
74067465|NCT02363010|147686700|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline half-mile walk time.||Exploring group differences in 18 month cardiorespiratory fitness, measured by half-mile walk time.||||.30
74067466|NCT02363010|147686701|SUPERIORITY|||||||0.59||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline waist circumference.||Exploring group differences in 12 month waist circumference.||||.59
73883368|NCT00083889|147300784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5136|||<|1e-05|TWO_SIDED|95.0|0.4196|0.6288||p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-a).||0.6288|0.4196|<.00001
74067467|NCT02363010|147686701|SUPERIORITY|||||||0.57||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline waist circumference.||Exploring group differences in 18 month waist circumference.||||.57
73883369|NCT00083889|147300785|SUPERIORITY_OR_OTHER||treatment difference|30.93|||<|0.001|TWO_SIDED|95.0|25.31|36.56|||Chi-squared||95% confidence interval was calculated based on a normal distribution.|||36.56|25.31|<0.001
73883370|NCT00083889|147300786|SUPERIORITY_OR_OTHER||treatment difference|33.66|||<|0.001|TWO_SIDED|95.0|27.62|39.69|||Chi-squared||95% confidence interval was calculated based on a normal distribution.|||39.69|27.62|<0.001
74067468|NCT02363010|147686702|SUPERIORITY|||||||0.978||||||A priori threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.978
74067469|NCT02363010|147686702|SUPERIORITY|||||||0.998||||||A priori threshold for statistical significance was p \<.05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.998
74067470|NCT02363010|147686702|SUPERIORITY|||||||0.878||||||A priori threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.878
74067471|NCT02363010|147686702|SUPERIORITY|||||||0.602||||||A priori threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.602
74067472|NCT02363010|147686703|SUPERIORITY|||||||0.487||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.487
73883371|NCT00083889|147300787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8209||||0.051|TWO_SIDED|95.0|0.673|1.0013||p-value is from 2-sided, unstratified tests.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||1.0013|0.6730|0.0510
74067473|NCT02363010|147686703|SUPERIORITY|||||||0.262||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.262
74067474|NCT02363010|147686703|SUPERIORITY|||||||0.851||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.851
74067475|NCT02363010|147686703|SUPERIORITY|||||||0.978||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.978
74067476|NCT02363010|147686704|SUPERIORITY|||||||0.796||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.796
74067477|NCT02363010|147686704|SUPERIORITY|||||||0.481||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.481
74067478|NCT02363010|147686704|SUPERIORITY|||||||0.872||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.872
74067479|NCT02363010|147686704|SUPERIORITY|||||||0.802||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.802
74067480|NCT02363010|147686705|SUPERIORITY|||||||0.926||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.926
74067481|NCT02363010|147686705|SUPERIORITY|||||||0.82||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.820
74067482|NCT02363010|147686705|SUPERIORITY|||||||0.127||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.127
74067483|NCT02363010|147686705|SUPERIORITY|||||||0.814||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.814
74067484|NCT04549259|147686723|SUPERIORITY||Odds Ratio (OR)|3.23||||0.33|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.33
73888308|NCT01746901|147309548|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.193|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.5|-2.6|0.1930
74067485|NCT04549259|147686723|SUPERIORITY||Odds Ratio (OR)|1.76||||0.63|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.63
74067486|NCT04549259|147686723|SUPERIORITY||Odds Ratio (OR)|0.68||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.78
74067487|NCT04549259|147686723|SUPERIORITY||Odds Ratio (OR)|0.87||||0.9|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.90
74067488|NCT04549259|147686723|OTHER|Single group change over time.|Odds Ratio (OR)|2.89||||0.38|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.38
74067489|NCT04549259|147686723|OTHER|Single group change over time.|Odds Ratio (OR)|1.25||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.78
74067490|NCT04549259|147686723|OTHER|Single group change over time.|Odds Ratio (OR)|2.32||||0.45|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.45
74067491|NCT04549259|147686723|OTHER|Single group change over time.|Odds Ratio (OR)|0.92||||0.91|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.91
74067492|NCT04549259|147686724|SUPERIORITY||B|2.58|STANDARD_ERROR_OF_MEAN|2.8||0.36|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.36
73883372|NCT00083889|147300787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8209||||0.0128|TWO_SIDED|95.0|0.673|1.0013||p-value is from 2-sided, unstratified tests.|Wilcoxon (Mann-Whitney)||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||1.0013|0.6730|0.0128
74067493|NCT04549259|147686724|SUPERIORITY||B|-0.42|STANDARD_ERROR_OF_MEAN|2.78||0.88|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.88
74067494|NCT04549259|147686724|SUPERIORITY||B|0.38|STANDARD_ERROR_OF_MEAN|2.8||0.89|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.89
74067495|NCT04549259|147686724|SUPERIORITY||B|-0.99|STANDARD_ERROR_OF_MEAN|2.78||0.73|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.73
74067496|NCT04549259|147686724|OTHER|Single group change over time.|B|4.88|STANDARD_ERROR_OF_MEAN|1.83||0.01|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.01
74067497|NCT04549259|147686724|OTHER|Single group change over time.|B|3.28|STANDARD_ERROR_OF_MEAN|2.03||0.12|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.12
74067498|NCT04549259|147686724|OTHER|Single group change over time.|B|3.82|STANDARD_ERROR_OF_MEAN|2.06||0.08|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.08
73883373|NCT00083889|147300787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8179||||0.049|TWO_SIDED|95.0|0.6692|0.9995||p-value is from 2-sided, stratified tests. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.9995|0.6692|0.0490
74067499|NCT04549259|147686724|OTHER|Single group change over time.|B|3.19|STANDARD_ERROR_OF_MEAN|1.99||0.12|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.12
74067500|NCT04549259|147686725|SUPERIORITY||Odds Ratio (OR)|22.3||||0.049|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.049
74067501|NCT04549259|147686725|SUPERIORITY||Odds Ratio (OR)|1.86||||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.66
74067502|NCT04549259|147686725|SUPERIORITY||Odds Ratio (OR)|0.68||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.78
73883374|NCT00083889|147300788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5332|||<|0.0001|TWO_SIDED|95.0|0.4345|0.6544||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-a)||0.6544|0.4345|<0.0001
74067503|NCT04549259|147686725|SUPERIORITY||Odds Ratio (OR)|0.43||||0.54|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.54
73888309|NCT01746901|147309548|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.031|TWO_SIDED|95.0|0.2|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|0.2|0.0310
74067504|NCT04549259|147686725|OTHER|Single group change over time.|Odds Ratio (OR)|6.26||||0.09|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.09
74067505|NCT04549259|147686725|OTHER|Single group change over time.|Odds Ratio (OR)|2.05||||0.4|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.40
74067506|NCT04549259|147686725|OTHER|Single group change over time.|Odds Ratio (OR)|1.42||||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.66
74067507|NCT04549259|147686725|OTHER|Single group change over time.|Odds Ratio (OR)|1.14||||0.87|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.87
74067508|NCT04549259|147686726|SUPERIORITY||B|-1.74|STANDARD_ERROR_OF_MEAN|1.47||0.24|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.24
74067509|NCT04549259|147686726|SUPERIORITY||B|-2.05|STANDARD_ERROR_OF_MEAN|1.46||0.17|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.17
74067510|NCT04549259|147686726|SUPERIORITY||B|0.64|STANDARD_ERROR_OF_MEAN|1.47||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.66
73888310|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|41.5|||<|0.0001|TWO_SIDED|95.0|33.9|49.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.0|33.9|<0.0001
73888311|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.3763|TWO_SIDED|95.0|-4.2|10.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.9|-4.2|0.3763
74067511|NCT04549259|147686726|SUPERIORITY||B|-0.21|STANDARD_ERROR_OF_MEAN|1.46||0.89|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.89
74067512|NCT04549259|147686726|OTHER|Single group change over time.|B|-1.6|STANDARD_ERROR_OF_MEAN|0.75||0.045|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.045
74067513|NCT04549259|147686726|OTHER|Single group change over time.|B|-1.81|STANDARD_ERROR_OF_MEAN|0.95||0.07|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.07
74067514|NCT04549259|147686726|OTHER|Single group change over time.|B|-0.51|STANDARD_ERROR_OF_MEAN|0.88||0.57|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.57
74067515|NCT04549259|147686726|OTHER|Single group change over time.|B|-0.92|STANDARD_ERROR_OF_MEAN|1.12||0.42|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.42
74067516|NCT00909727|147686727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|6.6|18.3||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline value of percent predicted FEV1.||18.3|6.6|<0.0001
74067517|NCT00909727|147686728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|2.7||0.0006|TWO_SIDED|95.0|4.5|15.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. no imputation of missing data was done.||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM). Estimates were obtained from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit \& treatment group, \& adjustment for the continuous baseline value of percent predicted FEV1, using unstructured covariance matrix.||15.5|4.5|0.0006
74067518|NCT00909727|147686729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|3.7||0.1092|TWO_SIDED|95.0|-1.4|13.5||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.||13.5|-1.4|0.1092
74067519|NCT00909727|147686729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|3.3||0.1354|TWO_SIDED|95.0|-1.6|11.8||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.||11.8|-1.6|0.1354
74067520|NCT00909727|147686730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.3|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|95.0|-61.8|-46.8||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.||-46.8|-61.8|<0.0001
74067521|NCT00909727|147686730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.5|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|95.0|-60.9|-46.0||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.||-46.0|-60.9|<0.0001
74067522|NCT00909727|147686731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.5||0.0004|TWO_SIDED|95.0|0.9|2.9||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||At Week 24: Analysis for this variable was based on a Linear Mixed Effect (LME) model with dependent variable weight; treatment as a fixed effect; and intercept, visit, and treatment by visit interaction as random effects, with adjustment for baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||2.9|0.9|0.0004
74067523|NCT00909727|147686731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.7||0.0002|TWO_SIDED|95.0|1.3|4.2||P-value is for the treatment effect at Week 48 (obtained as a linear contrast of treatment at Day 336). There was no adjustment for multiple comparisons.|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a Linear Mixed Effect (LME) model with random intercept and random slope, treatment as a fixed effect, and visit (days on study) and treatment by visit interaction as random effects, with adjustment for categorical baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||4.2|1.3|0.0002
74067524|NCT00672620|147686755|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.036||0.577|TWO_SIDED|95.0|-2.61|1.46||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||All statistical tests were 2-sided with 95% confidence intervals (CIs), and with P-values evaluated at the 5% significance level (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||1.46|-2.61|0.577
74067525|NCT00672620|147686755|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.038||0.138|TWO_SIDED|95.0|-3.58|0.5|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||||0.50|-3.58|0.138
74067526|NCT00672620|147686755|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.96|STANDARD_ERROR_OF_MEAN|1.047||0.005|TWO_SIDED|95.0|-5.02|-0.91|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||||-0.91|-5.02|0.005
74067527|NCT03211156|147686767|OTHER|||||||0.757|||||||Chi-squared, Corrected|||||||0.757
74067528|NCT03211156|147686768|OTHER|||||||0.048|||||||Fisher Exact|||||||0.048
74067529|NCT00124020|147686783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|0.2||||||95.0|-6.8|7.2||p-values were not calculated in deference to confidence intervals.||||||7.2|-6.8|
74067530|NCT01127581|147686791|SUPERIORITY_OR_OTHER||Median Difference (Net)|-677.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||Sample size 675 per group provides 90% power to see an improvement of ≥320 minutes (20% improvement from DVI) in time to vaginal delivery between MVI 200 \& DVI assuming a median time of 1600 minutes for DVI \& 34% dropout rate based on 5% 2-sided test|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||<0.001
73883375|NCT00083889|147300788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.516|||<|1e-05|TWO_SIDED|95.0|0.4191|0.6352||p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN-a)||0.6352|0.4191|<.00001
74067531|NCT01127581|147686792|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 675 subjects per group will provide a sufficient number of subjects to assess non-inferiority of MVI 200 with respect to rate of cesarean delivery, based on an alpha level of 5% and 80% power for a two-sided approach using a 10% non-inferiority limit (relative to the DVI rate), assuming a 30% rate of cesarean delivery in the DVI group compared to a 26% rate in the MVI 200 group.|Difference in Populations|-1.1|||||TWO_SIDED|95.0|-5.79|3.59|||Chi-squared||MVI 200 - DVI|The analysis of the cesarean delivery rates during the first hospitalization was based on a between-treatment-group difference. If the upper limit of the asymptotic two-sided 95% confidence interval of the difference in event rates (MVI minus DVI) was less than the calculated non-inferiority margin (10% relative to the DVI rate, i.e., 0.1 times DVI rate), then MVI 200 would be considered non-inferior to DVI.||3.59|-5.79|
74067532|NCT01127581|147686793|SUPERIORITY_OR_OTHER||Median Difference (Net)|-543.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||MVI 200 - DVI|Subjects who did not deliver during the first hospitalization were censored using the longest time interval from study drug administration to labor and delivery discharge without delivery, independent of treatment group.||||<0.001
74067533|NCT01127581|147686794|SUPERIORITY_OR_OTHER||Median Difference (Net)|-390.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||MVI 200 - DVI|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||<0.001
74067534|NCT01127581|147686795|SUPERIORITY_OR_OTHER||Difference in Proportions|-26.0|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
74067535|NCT01127581|147686796|SUPERIORITY_OR_OTHER||Difference in Proportions|9.67|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
74067536|NCT01127581|147686797|SUPERIORITY_OR_OTHER||Difference in Proportions|26.96|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
74067537|NCT01127581|147686798|SUPERIORITY_OR_OTHER||Difference in Proportions|13.9|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
74067538|NCT01127581|147686799|SUPERIORITY_OR_OTHER||Difference in Proportions|29.8|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
74067539|NCT01127581|147686800|SUPERIORITY_OR_OTHER||Difference in Proportions|1.68|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
74067540|NCT03175120|147686812|SUPERIORITY||Treatment contrast|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.09|-0.75|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and previous anti-diabetic treatment as fixed factors and corresponding baseline value as covariate.||-0.75|-1.09|<.0001
74067541|NCT01952574|147686918|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-1.12||||0.021|TWO_SIDED|95.0|-2.06|-0.17|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||-0.17|-2.06|0.021
74067542|NCT01952574|147686918|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-0.1||||0.83|TWO_SIDED|95.0|-1.07|0.86|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||0.86|-1.07|0.83
74067543|NCT01952574|147686918|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|0.11||||0.82|TWO_SIDED|92.0|-0.83|1.05|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||1.05|-0.83|0.82
74067544|NCT01952574|147686919|SUPERIORITY||Odds Ratio (OR)|2.0||||0.011|TWO_SIDED|95.0|1.17|3.42|||Generalised Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one percent change from baseline value in monthly migraine days (152 participants in the placebo group and 104 in the erenumab 70 mg group)||3.42|1.17|0.011
74067545|NCT01952574|147686919|SUPERIORITY||Odds Ratio (OR)|1.25||||0.44|TWO_SIDED|95.0|0.71|2.18|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 99 in the erenumab 21 mg group)||2.18|0.71|0.44
74067546|NCT01952574|147686919|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8|TWO_SIDED|95.0|0.53|1.63|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 107 in the erenumab 7 mg group)||1.63|0.53|0.80
74067547|NCT01952574|147686920|SUPERIORITY||LS Mean Difference|-0.4||||0.13|TWO_SIDED|95.0|-0.92|0.12|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.12|-0.92|0.13
74067548|NCT01952574|147686920|SUPERIORITY||LS Mean Difference|0.02||||0.95|TWO_SIDED|95.0|-0.51|0.54|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.54|-0.51|0.95
74067549|NCT01952574|147686920|SUPERIORITY||LS Mean Difference|0.37||||0.16|TWO_SIDED|95.0|-0.14|0.87|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.87|-0.14|0.16
74067550|NCT00770991|147686936|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||All patients received BRB suppositories and were pooled for the analysis comparing baseline and end of study polyp counts.||||0.065
74067551|NCT00770991|147686937|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0|||||Chi-squared|||||||0.016
74067552|NCT00770991|147686938|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.043
74067553|NCT01488019|147686957|NON_INFERIORITY|The hazard ratio and 90% two-sided confidence interval for the hazard ratio comparing Perforomist to placebo were estimated. Non-inferiority was declared if the upper limit of the two-sided 90% confidence interval was wholly less than 1.5.|Hazard Ratio (HR)|0.965|||||TWO_SIDED|90.0|0.711|1.308||Hazard Ratio was calculated as Perforomist vs Placebo. The non-inferiority margin for the hazard ratio is 1.5. Subjects with no primary event at withdrawal or study completion were treated as censored observations at time of withdrawal|Regression, Cox|Treatment, site group, and bronchodilator reversibility included as covariates in the model.|Hazard Ratio was calculated as Perforomist Inhalation Solution vs Placebo. The non-inferiority margin for the hazard ratio is 1.5.|||1.308|0.711|
74067554|NCT02400710|147686978|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANOVA|||||||.05
74067555|NCT02400710|147686979|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Chi-squared|||||||.05
74067556|NCT04147715|147686983|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9913|||||TWO_SIDED|90.0|0.9232|1.0645|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed by analysis of variance (ANOVA) fit with a linear mixed effect model with the natural log (ln)-transformed Cmax as the dependent variable, treatment as fixed effect, and participant as random effect. The difference and 90% confidence interval (CI) between the ln-transformed Cmax of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0645|0.9232|
74067557|NCT04147715|147686983|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9754|||||TWO_SIDED|90.0|0.8916|1.0671|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed by an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as fixed effect, and participant as random effect. The difference and 90% CI between the ln-transformed Cmax of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0671|0.8916|
74067558|NCT04147715|147686985|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0353|||||TWO_SIDED|90.0|0.9421|1.1377|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1377|0.9421|
74067559|NCT04147715|147686985|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9096|||||TWO_SIDED|90.0|0.8791|0.9411|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||0.9411|0.8791|
74067560|NCT04147715|147686986|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0071|||||TWO_SIDED|90.0|0.9679|1.0479|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0479|0.9679|
74067561|NCT04147715|147686986|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9852|||||TWO_SIDED|90.0|0.9605|1.0105|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0105|0.9605|
74067562|NCT04147715|147686988|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.1806|||||TWO_SIDED|90.0|1.1171|1.2477|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.2477|1.1171|
74067563|NCT04147715|147686988|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.048|||||TWO_SIDED|90.0|0.9656|1.1373|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1373|0.9656|
74067564|NCT04147715|147686990|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.3445|||||TWO_SIDED|90.0|1.2352|1.4636|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.4636|1.2352|
74067565|NCT04147715|147686990|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0769|||||TWO_SIDED|90.0|1.0137|1.1441|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1441|1.0137|
74067566|NCT04147715|147686991|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.1939|||||TWO_SIDED|90.0|1.1176|1.2754|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.2754|1.1176|
74067567|NCT04147715|147686991|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0482|||||TWO_SIDED|90.0|0.9881|1.1119|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1119|0.9881|
74067568|NCT04147715|147686993|OTHER||Slope|0.9857|||||TWO_SIDED|95.0|0.9341|1.0373||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(Cmax) = Intercept + Slope × ln(Dose) + Random error||1.0373|0.9341|
74067569|NCT04147715|147686993|OTHER||Geometric Least Squares Mean Ratio|0.8786|||||TWO_SIDED|90.0|0.7705|1.0019|||||Ratio = Fed / Fasted|"The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed state and fasted state using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as random effect.~The difference and 90% CI between the fed and fasted state ln-transformed Cmax were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.0019|0.7705|
74067570|NCT04147715|147686995|OTHER||Slope|1.0252|||||TWO_SIDED|95.0|0.984|1.0665||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(AUC0-last) = Intercept + Slope × ln(Dose) + Random error||1.0665|0.9840|
74067571|NCT04147715|147686995|OTHER||Geometric Least Squares Mean Ratio|0.9598|||||TWO_SIDED|90.0|0.8585|1.073|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed AUC0-last were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0730|0.8585|
74067572|NCT04147715|147686996|OTHER||Slope|1.028|||||TWO_SIDED|95.0|0.9866|1.0695||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(AUC0-inf) = Intercept + Slope × ln(Dose) + Random error||1.0695|0.9866|
74067573|NCT04147715|147686996|OTHER||Geometric Least Squares Mean Ratio|0.9646|||||TWO_SIDED|90.0|0.8643|1.0766|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed AUC0-inf were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0766|0.8643|
74067574|NCT04147715|147686997|OTHER||Geometric Least Squares Mean Ratio|1.0272|||||TWO_SIDED|90.0|0.9949|1.0606|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed t1/2,z as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed t1/2,z were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0606|0.9949|
74067575|NCT04147715|147687004|OTHER||Geometric Least Squares Mean Ratio|1.5167|||||TWO_SIDED|90.0|1.2654|1.818|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 Cmax after a single dose of S-648414 (Day 1) was assessed using an ANOVA model fitted to the ln-transformed Cmax, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed Cmax, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.8180|1.2654|
74067576|NCT04147715|147687004|OTHER||Geometric Least Squares Mean Ratio|1.8372|||||TWO_SIDED|90.0|1.5696|2.1506|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 Cmax after multiple doses of S-648414 (Day 14) was assessed using an ANOVA model fitted to the ln-transformed Cmax, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed Cmax, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.1506|1.5696|
74067577|NCT04147715|147687004|OTHER||Geometric Least Squares Mean Ratio|1.7489|||||TWO_SIDED|90.0|1.525|2.0057|||||Ratio = Day 14 / Day 1|"The accumulation ratio of Cmax in the 30 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed Cmax, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed Cmax on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0057|1.5250|
74067578|NCT04147715|147687004|OTHER||Geometric Least Squares Mean Ratio|2.1453|||||TWO_SIDED|90.0|1.9741|2.3313|||||Ratio = Day 14 / Day 1|"The accumulation ratio of Cmax in the 50 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed Cmax, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed Cmax on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.3313|1.9741|
74067579|NCT04147715|147687006|OTHER||Geometric Least Squares Mean Ratio|1.6277|||||TWO_SIDED|90.0|1.4038|1.8874|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 AUC0-τ after a single dose of S-648414 (Day 1) was assessed using an ANOVA model fitted to the ln-transformed AUC0-τ, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed AUC0-τ, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.8874|1.4038|
74067580|NCT04147715|147687006|OTHER||Geometric Least Squares Mean Ratio|1.7454|||||TWO_SIDED|90.0|1.4785|2.0605|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 AUC0-τ after multiple doses of S-648414 (Day 14) was assessed using an ANOVA model fitted to the ln-transformed AUC0-τ, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed AUC0-τ, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0605|1.4785|
74067581|NCT04147715|147687006|OTHER||Geometric Least Squares Mean Ratio|1.9102|||||TWO_SIDED|90.0|1.7788|2.0513|||||Ratio = Day 14 / Day 1|"The accumulation ratio of AUC0-τ in the 30 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed AUC0-τ, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed AUC0-τ on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0513|1.7788|
74067582|NCT04147715|147687006|OTHER||Geometric Least Squares Mean Ratio|2.0478|||||TWO_SIDED|90.0|1.9203|2.1837|||||Ratio = Day 14 / Day 1|"The accumulation ratio of AUC0-τ in the 50 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed AUC0-τ, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed AUC0-τ on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.1837|1.9203|
74067583|NCT04147715|147687013|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9241|||||TWO_SIDED|90.0|0.8057|1.06|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0600|0.8057|
74067584|NCT04147715|147687013|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0303|||||TWO_SIDED|90.0|0.9299|1.1415|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.1415|0.9299|
74067585|NCT04147715|147687015|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500|Geometric Least Squares Mean Ratio|0.842|||||TWO_SIDED|90.0|0.6628|1.0696|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-last of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0696|0.6628|
74067586|NCT04147715|147687015|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8542|||||TWO_SIDED|90.0|0.7185|1.0155|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-last of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0155|0.7185|
74067587|NCT04147715|147687016|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8377|||||TWO_SIDED|90.0|0.6645|1.0561|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-inf of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0561|0.6645|
74067588|NCT04147715|147687016|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8529|||||TWO_SIDED|90.0|0.7213|1.0085|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-inf of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0085|0.7213|
74067589|NCT03404206|147687030|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
74067590|NCT03404206|147687030|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
74067591|NCT03404206|147687031|SUPERIORITY||Least squares means|-34.73|||||TWO_SIDED|95.0|-45.67|-23.8|||ANCOVA|||||-23.8|-45.67|
74067592|NCT03404206|147687031|SUPERIORITY||Least squares means|-73.43|||||TWO_SIDED|95.0|-89.01|-57.85|||ANCOVA|||||-57.85|-89.01|
74067593|NCT03404206|147687031|SUPERIORITY||Least squares means|-38.7|||||TWO_SIDED|95.0|-54.29|-23.11|||ANCOVA|||||-23.11|-54.29|
74067594|NCT03404206|147687032|SUPERIORITY||Least squares means|-18.21|||||TWO_SIDED|95.0|-23.52|-12.89|||ANCOVA|||||-12.89|-23.52|
74067595|NCT03404206|147687032|SUPERIORITY||Least squares means|-33.72|||||TWO_SIDED|95.0|-41.29|-26.14|||ANCOVA|||||-26.14|-41.29|
74067596|NCT03404206|147687032|SUPERIORITY||Least squares means|-15.51|||||TWO_SIDED|95.0|-23.09|-7.93|||ANCOVA|||||-7.93|-23.09|
74067597|NCT02629965|147687048|SUPERIORITY||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.019|<|0.001|TWO_SIDED|95.0|0.077|0.153|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.153|0.077|<0.001
74067598|NCT02629965|147687049|SUPERIORITY||Mean Difference (Final Values)|4.168|STANDARD_ERROR_OF_MEAN|5.26||0.4291|TWO_SIDED|95.0|-6.211|14.548|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|14.548|-6.211|0.4291
74067599|NCT02629965|147687050|SUPERIORITY||Mean Difference (Final Values)|9.501|STANDARD_ERROR_OF_MEAN|83.704||0.9098|TWO_SIDED|95.0|-155.692|174.694|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|174.694|-155.692|0.9098
74067600|NCT02629965|147687051|SUPERIORITY||Mean Difference (Final Values)|-0.292|STANDARD_ERROR_OF_MEAN|0.469||0.5338|TWO_SIDED|95.0|-1.217|0.633|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.633|-1.217|0.5338
74067601|NCT02629965|147687052|SUPERIORITY||Mean Difference (Final Values)|0.939|STANDARD_ERROR_OF_MEAN|1.007||0.3524|TWO_SIDED|95.0|-1.048|2.926|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|2.926|-1.048|0.3524
74067602|NCT02629965|147687053|SUPERIORITY||Mean Difference (Final Values)|2.257|STANDARD_ERROR_OF_MEAN|2.647||0.3949|TWO_SIDED|95.0|-2.966|7.481|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|7.481|-2.966|0.3949
74067603|NCT02629965|147687054|SUPERIORITY||Mean Difference (Final Values)|2.42|STANDARD_ERROR_OF_MEAN|3.543||0.4955|TWO_SIDED|95.0|-4.572|9.411|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|9.411|-4.572|0.4955
74067604|NCT02629965|147687055|SUPERIORITY||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.091|0.176|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.176|0.091|<0.0001
74067605|NCT02629965|147687056|SUPERIORITY||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|0.088|0.123|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.123|0.088|<0.0001
74067606|NCT02629965|147687057|SUPERIORITY||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.13|0.197|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.197|0.130|<0.0001
74067607|NCT02629965|147687058|SUPERIORITY||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.103|0.162|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.162|0.103|<0.0001
74067608|NCT02629965|147687059|SUPERIORITY||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.1|0.156|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.156|0.100|<0.0001
74067609|NCT02629965|147687060|SUPERIORITY||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.056|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.108|0.056|<0.0001
74067610|NCT02629965|147687061|SUPERIORITY||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.058|0.114|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.114|0.058|<0.0001
74067611|NCT02629965|147687062|SUPERIORITY||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.059|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.108|0.059|<0.0001
74067612|NCT02629965|147687063|SUPERIORITY||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.114|0.189|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.189|0.114|<0.0001
74067613|NCT02330081|147687064|NON_INFERIORITY|The FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of platelet recovery must be ≥ 66% of fresh control platelet values|Risk Ratio (RR)|83.3|STANDARD_ERROR_OF_MEAN|4.97|||ONE_SIDED|95.0|76.2||||||Estimate is the ratio of the mean platelet recovery of treatment over control||||76.2|
74067614|NCT02330081|147687065|NON_INFERIORITY|One of the FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of the mean platelet survival time must be ≥58% of fresh control platelet mean survival time|Mean Ratio Survival Time|81.0|STANDARD_ERROR_OF_MEAN|2.0|||ONE_SIDED|95.0|77.0||||||Estimate is the ratio of the mean platelet survival time of treatment over control||||77.0|
74067615|NCT02826603|147687078|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.72|2.84|||Regression, Logistic|||||2.84|1.72|<0.0001
74067616|NCT02826603|147687079|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.63|2.72|||Regression, Logistic|||||2.72|1.63|<0.0001
74067617|NCT02826603|147687080|SUPERIORITY||Odds Ratio (OR)|2.62|||<|0.0001|TWO_SIDED|95.0|1.89|3.62|||Regression, Logistic|||||3.62|1.89|<0.0001
74067618|NCT02826603|147687081|SUPERIORITY||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.65|4.71|||Regression, Logistic|||||4.71|2.65|<0.0001
74067619|NCT02826603|147687082|SUPERIORITY||Odds Ratio (OR)|2.33|||<|0.0001|TWO_SIDED|95.0|1.8|3.01|||Regression, Logistic|||||3.01|1.80|<0.0001
74067620|NCT02826603|147687083|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.96|3.37|||Regression, Logistic|||||3.37|1.96|<0.0001
74067621|NCT02826603|147687084|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.89|3.31|||Regression, Logistic|||||3.31|1.89|<0.0001
74067622|NCT02826603|147687085|SUPERIORITY||Odds Ratio (OR)|2.86|||<|0.0001|TWO_SIDED|95.0|1.96|4.17|||Regression, Logistic|||||4.17|1.96|<0.0001
74067623|NCT02826603|147687086|SUPERIORITY||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|2.19|3.71|||Regression, Logistic|||||3.71|2.19|<0.0001
74067624|NCT02826603|147687087|SUPERIORITY||Odds Ratio (OR)|1.84|||<|0.0001|TWO_SIDED|95.0|1.41|2.41|||Regression, Logistic|||||2.41|1.41|<0.0001
74067625|NCT00895583|147687130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.239|TWO_SIDED|95.0|0.4|1.3||Two-sided alpha equals (=) 0.05.|Fisher Exact|||||1.3|0.4|0.239
74067626|NCT00895583|147687131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.422|TWO_SIDED|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact|||||1.4|0.5|0.422
74067627|NCT00895583|147687132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.524|TWO_SIDED|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact|||Month 12||1.4|0.5|0.524
74067628|NCT00895583|147687132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.298|TWO_SIDED|95.0|0.4|1.2||Alpha was unadjusted.|Fisher Exact|||Month 24||1.2|0.4|0.298
74067629|NCT00895583|147687133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.055|TWO_SIDED|95.0|0.3|1.0||Alpha was unadjusted.|Fisher Exact|||Month 12||1.0|0.3|0.055
74067630|NCT00895583|147687133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.33|TWO_SIDED|95.0|0.4|1.3||Alpha was unadjusted.|Fisher Exact|||Month 24||1.3|0.4|0.330
74067631|NCT00895583|147687134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.543|TWO_SIDED|95.0|0.4|1.5||Alpha was unadjusted.|Fisher Exact|||Month 12||1.5|0.4|0.543
74067632|NCT00895583|147687134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.6|1.8||Alpha was unadjusted.|Fisher Exact|||Month 24||1.8|0.6|1.000
74067633|NCT00895583|147687136|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.3||0.019|TWO_SIDED|95.0|0.5|5.5||Alpha was unadjusted.|ANCOVA|Analysis of covariance (ANCOVA) with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 6||5.5|0.5|0.019
74067634|NCT00895583|147687136|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.5||0.215|TWO_SIDED|95.0|-4.8|1.1||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 12||1.1|-4.8|0.215
74067635|NCT00895583|147687136|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.7||0.722|TWO_SIDED|95.0|-2.7|3.9||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 18||3.9|-2.7|0.722
74067636|NCT00895583|147687136|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.9||0.71|TWO_SIDED|95.0|-3.0|4.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 24||4.4|-3.0|0.710
74067637|NCT00895583|147687137|SUPERIORITY_OR_OTHER||Slope difference (SRL-TAC)|-1.8||||0.131|TWO_SIDED|95.0|-4.2|0.5|||Random coefficient model||Random coefficient model with GFR as the dependent variable and study day as the independent variable.|Slope difference (sirolimus \[SRL\] minus tacrolimus \[TAC\])||0.5|-4.2|0.131
74067638|NCT00895583|147687139|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.4||0.105|TWO_SIDED|95.0|-8.6|0.8||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 6||0.8|-8.6|0.105
74067639|NCT00895583|147687139|SUPERIORITY_OR_OTHER||LS Mean Difference|7.7|STANDARD_ERROR_OF_MEAN|3.3||0.023|TWO_SIDED|95.0|1.1|14.3||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 12||14.3|1.1|0.023
74067640|NCT00895583|147687139|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.4||0.955|TWO_SIDED|95.0|-6.8|6.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 18||6.4|-6.8|0.955
74067641|NCT00895583|147687139|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|5.8||0.582|TWO_SIDED|95.0|-8.2|14.6||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 24||14.6|-8.2|0.582
74067642|NCT00895583|147687140|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||||||0.006
74067643|NCT00895583|147687141|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 12 Post-transplantation||||1.000
74067644|NCT00895583|147687141|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 24 post-transplantation||||0.215
74067645|NCT00895583|147687142|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 6||||0.499
74067646|NCT00895583|147687142|SUPERIORITY_OR_OTHER|||||||0.067|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 12||||0.067
74067647|NCT00895583|147687142|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 18||||0.061
74067648|NCT00895583|147687142|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 24||||0.020
74067649|NCT00895583|147687145|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-therapy Period||||1.000
74067650|NCT00895583|147687145|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-therapy Period||||1.000
74067651|NCT00895583|147687146|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Baseline||||0.284
74067652|NCT00895583|147687146|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 12||||0.046
74067653|NCT00895583|147687146|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 24||||1.000
74067654|NCT00895583|147687147|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.81|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 12||||<0.001
74067655|NCT00895583|147687147|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 24||||<0.001
74067656|NCT00895583|147687147|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.824|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 12||||0.824
74067657|NCT00895583|147687147|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.735|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 24||||0.735
74067658|NCT00895583|147687147|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 12||||<0.001
74067659|NCT00895583|147687147|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.42|STANDARD_ERROR_OF_MEAN|0.13||0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 24||||0.001
74067660|NCT00895583|147687147|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.65|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 12||||<0.001
74067661|NCT00895583|147687147|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.37|STANDARD_ERROR_OF_MEAN|0.16||0.028|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 24||||0.028
74067662|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.429|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Baseline||||0.429
74067663|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.326|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 12||||0.326
74067664|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.517|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 24||||0.517
74067665|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agents (insulin), Baseline||||1.000
74067666|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 12||||1.000
74067667|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.223|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 24||||0.223
74067668|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.498|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Baseline||||0.498
74067669|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 12||||0.566
74067670|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 24||||0.423
74067671|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Baseline||||0.033
74067672|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 12||||0.900
74067673|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.802|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 24||||0.802
74067674|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Baseline||||0.260
74067675|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 12||||0.086
74067676|NCT00895583|147687148|SUPERIORITY_OR_OTHER|||||||0.723|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 24||||0.723
74067677|NCT00895583|147687149|SUPERIORITY_OR_OTHER||Treatment Ratio|1.71|||<|0.001|TWO_SIDED|95.0|1.38|2.11||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 12; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.||2.11|1.38|<0.001
74067678|NCT00895583|147687149|SUPERIORITY_OR_OTHER||Treatment Ratio|1.77|||<|0.001|TWO_SIDED|95.0|1.39|2.26||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 24; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.||2.26|1.39|<0.001
74067679|NCT00895583|147687150|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Pre-randomization||||1.000
74067680|NCT00895583|147687150|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period||||0.020
74067681|NCT00895583|147687150|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period||||0.021
74067682|NCT00895583|147687151|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Alpha is unadjusted.|Fisher Exact|||||||<0.001
74067683|NCT00895583|147687152|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period, any treatment||||<0.001
74067684|NCT00895583|147687152|SUPERIORITY_OR_OTHER|||||||0.685|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period, any treatment||||0.685
74067685|NCT00895583|147687153|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.521|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|||||||0.521
74067686|NCT00895583|147687154|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.25||0.265|TWO_SIDED|||||Alpha is unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.265
74067687|NCT00895583|147687155|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|10.02|STANDARD_ERROR_OF_MEAN|23.61||0.672|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.672
74067688|NCT00895583|147687156|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.45|STANDARD_ERROR_OF_MEAN|0.67||0.504|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.504
74067689|NCT00895583|147687157|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.56|STANDARD_ERROR_OF_MEAN|1.18||0.637|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.637
74067690|NCT00895583|147687158|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.08|STANDARD_ERROR_OF_MEAN|1.48||0.955|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.955
74067691|NCT00895583|147687159|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|216.29|STANDARD_ERROR_OF_MEAN|198.84||0.279|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.279
74067692|NCT00895583|147687160|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.22|STANDARD_ERROR_OF_MEAN|0.23||0.337|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|||||||0.337
74067693|NCT00895583|147687161|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset (from baseline up to On-Therapy Month 24)||||0.025
74067694|NCT00895583|147687161|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset at 1 year (from baseline up to On-Therapy Month 12)||||0.012
74067695|NCT00895583|147687161|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset at 2 years (from On-Therapy Month 12 to On-Therapy Month 24)||||1.000
74067696|NCT00895583|147687162|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Insulin (12-Month)||||1.000
74067697|NCT00895583|147687162|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (12-Month)||||1.000
74067698|NCT00895583|147687162|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (24-Month)||||0.386
74067699|NCT00895583|147687162|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Insulin (24-Month)||||1.000
74067700|NCT00895583|147687163|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED||||||Fisher Exact|||||||0.129
74067701|NCT00895583|147687164|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
74067702|NCT00895583|147687165|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Fisher Exact|||||||0.276
74067703|NCT00895583|147687166|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED||||||Fisher Exact|||||||0.158
74067704|NCT01360632|147687195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.0925|TWO_SIDED|95.0|-2.58|0.2|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||0.2|-2.58|0.0925
74067705|NCT01360632|147687195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.0327|TWO_SIDED|95.0|-2.92|-0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a MMRM analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||-0.13|-2.92|0.0327
74067706|NCT01360632|147687196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0737|TWO_SIDED|95.0|-2.73|0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.13|-2.73|0.0737
74067707|NCT01360632|147687196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95||||0.0079|TWO_SIDED|95.0|-3.39|-0.51|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.51|-3.39|0.0079
74067708|NCT01360632|147687197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.0096|TWO_SIDED|95.0|-1.86|-0.26|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.26|-1.86|0.0096
74067709|NCT01360632|147687197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.4137|TWO_SIDED|95.0|-1.14|0.47|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.47|-1.14|0.4137
74067710|NCT01360632|147687197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.0065|TWO_SIDED|95.0|-2.47|-0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.4|-2.47|0.0065
74067711|NCT01360632|147687197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.0914|TWO_SIDED|95.0|-1.93|0.14|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.14|-1.93|0.0914
74067712|NCT01360632|147687197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0139|TWO_SIDED|95.0|-2.5|-0.28|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.28|-2.5|0.0139
74067713|NCT01360632|147687197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.2097|TWO_SIDED|95.0|-1.82|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.4|-1.82|0.2097
74067714|NCT01360632|147687197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.0099|TWO_SIDED|95.0|-2.75|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.38|-2.75|0.0099
73883376|NCT00083889|147300789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5454|||<|0.0001|TWO_SIDED|95.0|0.4558|0.6526||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio \> 1 indicates a reduction in hazard rate in favor of IFN-a.|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-α)||0.6526|0.4558|<0.0001
74067715|NCT01360632|147687197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.034|TWO_SIDED|95.0|-2.48|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.1|-2.48|0.034
74067716|NCT01360632|147687197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0177|TWO_SIDED|95.0|-2.8|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.27|-2.8|0.0177
74067717|NCT01360632|147687197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.0085|TWO_SIDED|95.0|-2.98|-0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.44|-2.98|0.0085
74067718|NCT01360632|147687198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.0286|TWO_SIDED|95.0|-1.74|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.1|-1.74|0.0286
74067719|NCT01360632|147687198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.3173|TWO_SIDED|95.0|-1.24|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.4|-1.24|0.3173
74067720|NCT01360632|147687198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0313|TWO_SIDED|95.0|-2.23|-0.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.11|-2.23|0.0313
74067721|NCT01360632|147687198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.0732|TWO_SIDED|95.0|-2.04|0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.09|-2.04|0.0732
74067722|NCT01360632|147687198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0206|TWO_SIDED|95.0|-2.51|-0.21|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.21|-2.51|0.0206
74067723|NCT01360632|147687198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.1233|TWO_SIDED|95.0|-2.06|0.25|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.25|-2.06|0.1233
74067724|NCT01360632|147687198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.0097|TWO_SIDED|95.0|-2.84|-0.39|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.39|-2.84|0.0097
74067725|NCT01360632|147687198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0092|TWO_SIDED|95.0|-2.86|-0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.41|-2.86|0.0092
74067726|NCT01360632|147687198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0139|TWO_SIDED|95.0|-2.94|-0.33|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.33|-2.94|0.0139
74067727|NCT01360632|147687198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.0015|TWO_SIDED|95.0|-3.42|-0.81|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.81|-3.42|0.0015
74067728|NCT01360632|147687199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0008|TWO_SIDED|95.0|-0.87|-0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.23|-0.87|0.0008
74067729|NCT01360632|147687199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.5792|TWO_SIDED|95.0|-0.41|0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B||0.23|-0.41|0.5792
74067730|NCT01360632|147687199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0091|TWO_SIDED|95.0|-0.87|-0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.12|-0.87|0.0091
74067731|NCT01360632|147687199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0474|TWO_SIDED|95.0|-0.73|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.73|0.0474
74067732|NCT01360632|147687200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.0015|TWO_SIDED|95.0|-0.94|-0.22||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.22|-0.94|0.0015
74067733|NCT01360632|147687200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.2627|TWO_SIDED|95.0|-0.56|0.15||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate|Mixed Models Analysis|||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.15|-0.56|0.2627
74067734|NCT01360632|147687200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0158|TWO_SIDED|95.0|-0.89|-0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3||-0.09|-0.89|0.0158
74067735|NCT01360632|147687200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0191|TWO_SIDED|95.0|-0.88|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.08|-0.88|0.0191
74067736|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0377|TWO_SIDED|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11||-0.03|-0.88|0.0377
74067737|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.0741|TWO_SIDED|95.0|-0.91|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis||-0.43|For Item: Work/School: Week 14||0.04|-0.91|0.0741
74067738|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.0966|TWO_SIDED|95.0|-0.07|0.81||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||For Item: Work/School: Week 11||0.81|-0.07|0.0966
74067739|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.4774|TWO_SIDED|95.0|-0.66|0.31|||Mixed Models Analysis|||For Item: Work/School: Week 14||0.31|-0.66|0.4774
74067740|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0263|TWO_SIDED|95.0|-0.76|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||-0.05|-0.76|0.0263
74067741|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0214|TWO_SIDED|95.0|-0.89|-0.07|||Mixed Models Analysis|||Social life: Week 14||-0.07|-0.89|0.0214
74067742|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8281|TWO_SIDED|95.0|-0.4|0.32||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||0.32|-0.40|0.8281
74067743|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.054|TWO_SIDED|95.0|-0.8|0.01|||Mixed Models Analysis|||Social life: Week 14||0.01|-0.80|0.0540
74067744|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.0008|TWO_SIDED|95.0|-0.99|-0.26||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||-0.26|-0.99|0.0008
74067745|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0093|TWO_SIDED|95.0|-0.97|-0.14|||Mixed Models Analysis|||Family life: Week 14||-0.14|-0.97|0.0093
74067746|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.2182|TWO_SIDED|95.0|-0.59|0.14|||Mixed Models Analysis|||Family life: Week 11||0.14|-0.59|0.2182
74067747|NCT01360632|147687201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0256|TWO_SIDED|95.0|-0.9|-0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14||-0.06|-0.90|0.0256
74067748|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0341|TWO_SIDED|95.0|-1.01|-0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11||-0.04|-1.01|0.0341
74067749|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0816|TWO_SIDED|95.0|-0.99|0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||School/work: Week 14||0.06|-0.99|0.0816
74067750|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.2561|TWO_SIDED|95.0|-0.21|0.78||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11||0.78|-0.21|0.2561
74067751|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.2952|TWO_SIDED|95.0|-0.82|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 14||0.25|-0.82|0.2952
74067752|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.0331|TWO_SIDED|95.0|-0.82|-0.03||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||-0.03|-0.82|0.0331
74067753|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.0352|TWO_SIDED|95.0|-0.9|-0.03|||Mixed Models Analysis|||Social life: Week 14||-0.03|-0.90|0.0352
74067754|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.486|TWO_SIDED|95.0|-0.54|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||0.25|-0.54|0.4860
74067755|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0282|TWO_SIDED|95.0|-0.93|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 14||-0.05|-0.93|0.0282
74067756|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0016|TWO_SIDED|95.0|-1.01|-0.24||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||-0.24|-1.01|0.0016
74067757|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.0186|TWO_SIDED|95.0|-0.94|-0.09|||Mixed Models Analysis|||Family life: Week 14||-0.09|-0.94|0.0186
73888312|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|18.3|||<|0.0001|TWO_SIDED|95.0|10.7|25.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.8|10.7|<0.0001
74067758|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0824|TWO_SIDED|95.0|-0.73|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||0.04|-0.73|0.0824
74067759|NCT01360632|147687202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||0.0077|TWO_SIDED|95.0|-1.02|-0.16||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14||-0.16|-1.02|0.0077
74067760|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.0436|TWO_SIDED|95.0|-0.18|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.18|0.0436
74067761|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||-0.06|TWO_SIDED|95.0|-0.15|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.03|-0.15|-0.06
74067762|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0012|TWO_SIDED|95.0|-0.34|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.08|-0.34|0.0012
74067763|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0266|TWO_SIDED|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.02|-0.27|0.0266
74067764|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0034|TWO_SIDED|95.0|-0.33|-0.07|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.07|-0.33|0.0034
74067765|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.3053|TWO_SIDED|95.0|-0.2|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.06|-0.2|0.3053
74067766|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0541|TWO_SIDED|95.0|-0.29|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.29|0.0541
74067767|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0912|TWO_SIDED|95.0|-0.28|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.02|-0.28|0.0912
74067768|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.1553|TWO_SIDED|95.0|-0.28|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.04|-0.28|0.1553
74067769|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1855|TWO_SIDED|95.0|-0.27|0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.05|-0.27|0.1855
74067770|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.2015|TWO_SIDED|95.0|-0.28|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.06|-0.28|0.2015
74067771|NCT01360632|147687203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0852|TWO_SIDED|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.02|-0.32|0.0852
74067772|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.08||||0.0817|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.01|-0.17|0.0817
74067773|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.1406|TWO_SIDED|95.0|-0.16|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.02|-0.16|0.1406
74067774|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.011|TWO_SIDED|95.0|-0.29|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.04|-0.29|0.011
74067775|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0287|TWO_SIDED|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.02|-0.27|0.0287
74067776|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0071|TWO_SIDED|95.0|-0.32|-0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.05|-0.32|0.0071
74067777|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.2503|TWO_SIDED|95.0|-0.22|-0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.06|-0.22|0.2503
74067778|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0539|TWO_SIDED|95.0|-0.3|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0|-0.3|0.0539
74067779|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0398|TWO_SIDED|95.0|-0.31|-0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.01|-0.31|0.0398
74067780|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.1168|TWO_SIDED|95.0|-0.3|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.03|-0.3|0.1168
74067781|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0621|TWO_SIDED|95.0|-0.32|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.01|-0.32|0.0621
74067782|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.089|TWO_SIDED|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.02|-0.32|0.089
74067783|NCT01360632|147687204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0213|TWO_SIDED|95.0|-0.38|-0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.03|-0.38|0.0213
74067784|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0228|TWO_SIDED|95.0|-2.37|-0.18|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.18|-2.37|0.0228
74067785|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.5081|TWO_SIDED|95.0|-1.47|0.73|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.73|-1.47|0.5081
74067786|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.0064|TWO_SIDED|95.0|-3.2|-0.53|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.53|-3.2|0.0064
74067787|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.1898|TWO_SIDED|95.0|-2.23|0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.44|-2.23|0.1898
74067788|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.09||||0.0074|TWO_SIDED|95.0|-3.62|-0.56|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.56|-3.62|0.0074
74067789|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.5935|TWO_SIDED|95.0|-1.95|1.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||1.11|-1.95|0.5935
74067790|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0211|TWO_SIDED|95.0|-3.52|-0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.29|-3.52|0.0211
74067791|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.1031|TWO_SIDED|95.0|-2.96|0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.27|-2.96|0.1031
74067792|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1366||||0.1366|TWO_SIDED|95.0|-3.02|0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.41|-3.02|0.1366
74067793|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.2709|TWO_SIDED|95.0|-2.68|0.75|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.75|-2.68|0.2709
74067794|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.0812|TWO_SIDED|95.0|-3.4|0.2|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.2|-3.4|0.0812
74067795|NCT01360632|147687205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.1001|TWO_SIDED|95.0|-3.33|0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.29|-3.33|0.1001
74067796|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.0496|TWO_SIDED|95.0|-2.24|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0|-2.24|0.0496
74067797|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.387|TWO_SIDED|95.0|-1.61|0.63|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.63|-1.61|0.387
74067798|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.0125|TWO_SIDED|95.0|-3.13|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.38|-3.13|0.0125
74067799|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.0898|TWO_SIDED|95.0|-2.57|0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.19|-2.57|0.0898
74067800|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.004|TWO_SIDED|95.0|-3.88|-0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.74|-3.88|0.004
74067801|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.301|TWO_SIDED|95.0|-2.4|0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.74|-2.4|0.301
74067802|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.0118|TWO_SIDED|95.0|-3.82|-0.48|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.48|-3.82|0.0118
74067803|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.0287|TWO_SIDED|95.0|-3.54|-0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.19|-3.54|0.0287
74067804|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0686|TWO_SIDED|95.0|-3.39|0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.12|-3.39|0.0686
74067805|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.056|TWO_SIDED|95.0|-3.47|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.04|-3.47|0.056
74067806|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0448|TWO_SIDED|95.0|-3.75|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.04|-3.75|0.0448
74067807|NCT01360632|147687206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.0251|TWO_SIDED|95.0|-3.98|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.27|-3.98|0.0251
74067808|NCT01360632|147687207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.1732|TWO_SIDED|95.0|-1.63|0.29|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.||0.29|-1.63|0.1732
74067809|NCT01360632|147687207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0066|TWO_SIDED|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.||-0.37|-2.31|0.0066
74067810|NCT01360632|147687208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.1226|TWO_SIDED|95.0|-1.78|0.21|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.21|-1.78|0.1226
74067811|NCT01360632|147687208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69||||0.001|TWO_SIDED|95.0|-2.69|-0.68|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.68|-2.69|0.001
74067812|NCT01360632|147687209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8164|TWO_SIDED|95.0|-0.93|0.73|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.73|-0.93|0.8164
74067813|NCT01360632|147687209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.1939|TWO_SIDED|95.0|-1.39|0.28|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.28|-1.39|0.1939
74067814|NCT01360632|147687210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.5192|TWO_SIDED|95.0|-1.14|0.57|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.57|-1.14|0.5192
74067815|NCT01360632|147687210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.0443|TWO_SIDED|95.0|-1.75|-0.02|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.02|-1.75|0.0443
74067816|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0248|TWO_SIDED|95.0|-0.26|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.02|-0.26|0.0248
74067817|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1334|TWO_SIDED|95.0|-0.22|0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.03|-0.22|0.1334
74067818|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0009|TWO_SIDED|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.11|-0.42|0.0009
74067819|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0019|TWO_SIDED|95.0|-0.38|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.09|-0.38|0.0019
74067820|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0009|TWO_SIDED|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.11|-0.42|0.0009
74067821|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.0254|TWO_SIDED|95.0|-0.34|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.02|-0.34|0.0254
74067822|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0035|TWO_SIDED|95.0|-0.41|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.08|-0.41|0.0035
74067823|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0152|TWO_SIDED|95.0|-0.39|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.04|-0.39|0.0152
74067824|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.004|TWO_SIDED|95.0|-0.42|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.08|-0.42|0.004
74067825|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.013|TWO_SIDED|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.05|-0.42|0.013
74067826|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0755|TWO_SIDED|95.0|-0.33|0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.02|-0.33|0.0755
74067827|NCT01360632|147687211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0527|TWO_SIDED|95.0|-0.39|0.0|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0|-0.39|0.0527
74067828|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0275|TWO_SIDED|95.0|-0.26|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.01|-0.26|0.0275
74067829|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.1583|TWO_SIDED|95.0|-0.22|0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.04|-0.22|0.1583
74067830|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0021|TWO_SIDED|95.0|-0.41|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.41|0.0021
74067831|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0018|TWO_SIDED|95.0|-0.4|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.4|0.0018
74067832|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0011|TWO_SIDED|95.0|-0.43|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.11|-0.43|0.0011
74067833|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0235|TWO_SIDED|95.0|-0.36|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.03|-0.36|0.0235
74067834|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0021|TWO_SIDED|95.0|-0.44|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.10|-0.44|0.0021
74067835|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0111|TWO_SIDED|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.05|-0.42|0.0111
74067836|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.003|TWO_SIDED|95.0|-0.44|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.44|0.0030
74067837|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0046|TWO_SIDED|95.0|-0.47|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.47|0.0046
74067838|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0237|TWO_SIDED|95.0|-0.39|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.03|-0.39|0.0237
74067839|NCT01360632|147687212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0171|TWO_SIDED|95.0|-0.45|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.04|-0.45|0.0171
74067840|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.5279|TWO_SIDED|95.0|0.51|3.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.68|0.51|0.5279
74067841|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|0.13||||0.0141|TWO_SIDED|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.94|0.02|0.0141
74067842|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|1.92||||0.0484|TWO_SIDED|95.0|0.99|3.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.72|0.99|0.0484
74067843|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|1.23||||0.5813|TWO_SIDED|95.0|0.6|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.50|0.60|0.5813
73883377|NCT00083889|147300789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5417|||<|1e-05|TWO_SIDED|95.0|0.4519|0.6492||p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN-α)||0.6492|0.4519|<.00001
74067844|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.1236|TWO_SIDED|95.0|0.9|2.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.54|0.90|0.1236
74067845|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|1.21||||0.4998|TWO_SIDED|95.0|0.7|2.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.10|0.70|0.4998
74067846|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|1.64||||0.0365|TWO_SIDED|95.0|1.03|2.61|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.61|1.03|0.0365
74067847|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|1.52||||0.0822|TWO_SIDED|95.0|0.95|2.43|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.43|0.95|0.0822
74067848|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|1.19||||0.4049|TWO_SIDED|95.0|0.79|1.78|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.78|0.79|0.4049
74067849|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|1.23||||0.2951|TWO_SIDED|95.0|0.84|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.80|0.84|0.2951
74067850|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|1.53||||0.0248|TWO_SIDED|95.0|1.06|2.2|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.20|1.06|0.0248
74067851|NCT01360632|147687213|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.0326|TWO_SIDED|95.0|1.03|2.21|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.21|1.03|0.0326
74067852|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|0.87||||0.7993|TWO_SIDED|95.0|0.3|2.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.55|0.30|0.7993
74067853|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|0.11||||0.0118|TWO_SIDED|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.93|0.01|0.0118
74067854|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|1.5||||0.2825|TWO_SIDED|95.0|0.71|3.16|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.16|0.71|0.2825
74067855|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|1.2||||0.6375|TWO_SIDED|95.0|0.58|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|0.58|0.6375
74067856|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.0923|TWO_SIDED|95.0|0.92|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.82|0.92|0.0923
74067857|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|1.29||||0.3812|TWO_SIDED|95.0|0.73|2.3|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.30|0.73|0.3812
74067858|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|1.63||||0.0464|TWO_SIDED|95.0|1.0|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.65|1.00|0.0464
74067859|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.049|TWO_SIDED|95.0|1.0|2.64|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.64|1.00|0.0490
74067860|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|1.32||||0.2124|TWO_SIDED|95.0|0.85|2.06|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.06|0.85|0.2124
74067861|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.1078|TWO_SIDED|95.0|0.93|2.14|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.14|0.93|0.1078
74067862|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|1.69||||0.0094|TWO_SIDED|95.0|1.14|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|1.14|0.0094
74067863|NCT01360632|147687214|SUPERIORITY_OR_OTHER||Ratio of response rate|1.65||||0.0162|TWO_SIDED|95.0|1.09|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|1.09|0.0162
74067864|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of remission rate|1.03||||0.9498|TWO_SIDED|95.0|0.37|2.9|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.90|0.37|0.9498
74067865|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of response rate|0.13||||0.0141|TWO_SIDED|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.94|0.02|0.0141
74067866|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of response rate|0.93||||0.8609|TWO_SIDED|95.0|0.4|2.17|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.17|0.40|0.8609
74067867|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of response rate|0.59||||0.2846|TWO_SIDED|95.0|0.22|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.54|0.22|0.2846
74067868|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of response rate|1.5||||0.248|TWO_SIDED|95.0|0.75|2.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.99|0.75|0.2480
74067869|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of response rate|1.13||||0.7513|TWO_SIDED|95.0|0.54|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.37|0.54|0.7513
74067870|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of response rate|1.82||||0.0554|TWO_SIDED|95.0|0.99|3.35|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.35|0.99|0.0554
74067871|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of response rate|1.48||||0.2409|TWO_SIDED|95.0|0.76|2.87|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.87|0.76|0.2409
74067872|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of response rate|1.18||||0.5538|TWO_SIDED|95.0|0.69|2.02|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.02|0.69|0.5538
74067873|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of response rate|1.44||||0.1743|TWO_SIDED|95.0|0.85|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.41|0.85|0.1743
74067874|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of response rate|1.3||||0.2843|TWO_SIDED|95.0|0.81|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.07|0.81|0.2843
74067875|NCT01360632|147687215|SUPERIORITY_OR_OTHER||Ratio of response rate|1.19||||0.464|TWO_SIDED|95.0|0.74|1.92|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.92|0.74|0.4640
74067876|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|0.6||||0.3867|TWO_SIDED|95.0|0.18|1.97|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.97|0.18|0.3867
74067877|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|0.11||||0.0118|TWO_SIDED|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.93|0.01|0.0118
74067878|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|0.59||||0.32|TWO_SIDED|95.0|0.21|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.66|0.21|0.3200
74067879|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|0.6||||0.3266|TWO_SIDED|95.0|0.23|1.62|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.62|0.23|0.3266
74067880|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|1.47||||0.3027|TWO_SIDED|95.0|0.7|3.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.10|0.70|0.3027
74067881|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|1.17||||0.696|TWO_SIDED|95.0|0.54|2.52|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.52|0.54|0.6960
74067882|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.1368|TWO_SIDED|95.0|0.86|3.07||CMH general association test controlling for trial site|Cochran-Mantel-Haenszel|||Statistical analysis 1 at Week 12 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.07|0.86|0.1368
74067883|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|1.48||||0.2387|TWO_SIDED|95.0|0.76|2.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.89|0.76|0.2387
73883378|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.913|||<|0.0001|TWO_SIDED|95.0|1.376|2.45|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) baseline score (intercept and time since randomization are included as random effects).||2.450|1.376|<.0001
73883379|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.935|||<|0.0001|TWO_SIDED|95.0|1.421|2.449|||Mixed Models Analysis|||Cycle 1 Day 28: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.449|1.421|<.0001
74067884|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|1.26||||0.4498|TWO_SIDED|95.0|0.69|2.28|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.28|0.69|0.4498
74067885|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|1.6||||0.1009|TWO_SIDED|95.0|0.91|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.82|0.91|0.1009
74067886|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|1.45||||0.1499|TWO_SIDED|95.0|0.87|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.41|0.87|0.1499
74067887|NCT01360632|147687216|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.3012|TWO_SIDED|95.0|0.78|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.18|0.78|0.3012
74067888|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.2873|TWO_SIDED|95.0|0.75|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.65|0.75|0.2873
74067889|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.2677|TWO_SIDED|95.0|0.79|2.36|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.36|0.79|0.2677
74067890|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.8||||0.0031|TWO_SIDED|95.0|1.21|2.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.68|1.21|0.0031
74067891|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.7||||0.0066|TWO_SIDED|95.0|1.15|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.50|1.15|0.0066
74067892|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.34||||0.0665|TWO_SIDED|95.0|0.98|1.83|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.83|0.98|0.0665
74067893|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.025|TWO_SIDED|95.0|1.05|1.91|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.91|1.05|0.0250
74067894|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.18||||0.2224|TWO_SIDED|95.0|0.9|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.54|0.90|0.2224
74067895|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.0369|TWO_SIDED|95.0|1.01|1.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.68|1.01|0.0369
74067896|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.36||||0.0179|TWO_SIDED|95.0|1.05|1.75|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.75|1.05|0.0179
74067897|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.49||||0.0011|TWO_SIDED|95.0|1.17|1.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.89|1.17|0.0011
74067898|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.12||||0.3249|TWO_SIDED|95.0|0.89|1.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.41|0.89|0.3249
74067899|NCT01360632|147687217|SUPERIORITY_OR_OTHER||Ratio of response rate|1.33||||0.0122|TWO_SIDED|95.0|1.06|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.66|1.06|0.0122
74067900|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.22||||0.5836|TWO_SIDED|95.0|0.6|2.49|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.49|0.60|0.5836
74067901|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.3792|TWO_SIDED|95.0|0.73|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.37|0.73|0.3792
74067902|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.77||||0.0101|TWO_SIDED|95.0|1.14|2.74|||Ratio of response rate|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.74|1.14|0.0101
74067903|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.75||||0.0065|TWO_SIDED|95.0|1.17|2.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.63|1.17|0.0065
74067904|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.0526|TWO_SIDED|95.0|1.0|1.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.99|1.00|0.0526
74067905|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.0156|TWO_SIDED|95.0|1.08|2.11|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.11|1.08|0.0156
74067906|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.22||||0.1689|TWO_SIDED|95.0|0.92|1.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.63|0.92|0.1689
74067907|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.0231|TWO_SIDED|95.0|1.04|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.80|1.04|0.0231
74067908|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.4||||0.0175|TWO_SIDED|95.0|1.06|1.84|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.84|1.06|0.0175
74067909|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.59||||0.0004|TWO_SIDED|95.0|1.22|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.07|1.22|0.0004
74067910|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.21||||0.1396|TWO_SIDED|95.0|0.94|1.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.55|0.94|0.1396
74067911|NCT01360632|147687218|SUPERIORITY_OR_OTHER||Ratio of response rate|1.46||||0.0016|TWO_SIDED|95.0|1.15|1.86|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.86|1.15|0.0016
74067912|NCT02173301|147687219|SUPERIORITY|||||||0.066|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||0.066
74067913|NCT02173301|147687219|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||0.001
73883380|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.948|||<|0.0001|TWO_SIDED|95.0|1.443|2.452|||Mixed Models Analysis|||Cycle 2 Day 1: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.452|1.443|<.0001
74067914|NCT02173301|147687219|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||<0.001
74067915|NCT02173301|147687220|SUPERIORITY|||||||0.501|||||||Regression, Logistic|||Week 12 comparison||||0.501
73888313|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|26.6|||<|0.0001|TWO_SIDED|95.0|19.1|34.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.1|19.1|<0.0001
74067916|NCT02173301|147687220|SUPERIORITY|||||||0.34|||||||Regression, Logistic|||Week 12 comparison||||0.340
74067917|NCT02173301|147687220|SUPERIORITY|||||||0.075|||||||Regression, Logistic|||Week 12 comparison||||0.075
74067918|NCT02173301|147687221|SUPERIORITY|||||||0.229|||||||Regression, Logistic|||Week 12 comparison||||0.229
74067919|NCT02173301|147687221|SUPERIORITY|||||||0.604|||||||Regression, Logistic|||Week 12 comparison||||0.604
74067920|NCT02173301|147687221|SUPERIORITY|||||||0.573|||||||Regression, Logistic|||Week 12 comparison||||0.573
74067921|NCT01710306|147687230|SUPERIORITY|||||||0.1996|||||||Chi-squared|||||||0.1996
74067922|NCT01191255|147687235|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The P-value for the change in mean serum phosphorus was calculated via an ANCOVA model with treatment as the fixed effect and Week-52-baseline as the co-variate.|ANCOVA|||||||<0.0001
74067923|NCT01191255|147687236|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The P-value for the change in mean serum Ferritin were created via an ANCOVA model with treatment as the fixed effect and Study-baseline as the co-variate.|ANCOVA|||||||<0.0001
74067924|NCT01191255|147687237|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
74067925|NCT01191255|147687238|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74067926|NCT01191255|147687239|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74067927|NCT02196506|147687240|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.0074|TWO_SIDED|95.0|-3.97|-0.62|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.62|-3.97|0.0074
74067928|NCT02196506|147687241|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.3331|TWO_SIDED|95.0|-0.66|0.23|||Mixed Models Analysis|||Statistical Analysis at Week 14||0.23|-0.66|0.3331
74067929|NCT02196506|147687242|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.0263|TWO_SIDED|95.0|-4.23|-0.27|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.27|-4.23|0.0263
74067930|NCT02196506|147687243|SUPERIORITY||Mean Difference (Final Values)|-2.98||||0.0099|TWO_SIDED|95.0|-5.24|-0.72|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.72|-5.24|0.0099
74067931|NCT01743677|147687260|SUPERIORITY||Least Squares Mean Difference|-1.29|||||TWO_SIDED|90.0|-3.15|0.56||||||||0.56|-3.15|
74067932|NCT01743677|147687261|SUPERIORITY||Least Squares Mean Difference|-1.42|||||TWO_SIDED|90.0|-3.28|0.43||||||||0.43|-3.28|
74067933|NCT01743677|147687262|SUPERIORITY||Least Squares Mean Difference|-2.29|||||TWO_SIDED|90.0|-4.15|-0.44||||||||-0.44|-4.15|
74067934|NCT01743677|147687263|SUPERIORITY||Least Squares Mean Difference|-1.35|||||TWO_SIDED|90.0|-3.21|0.5||||||||0.50|-3.21|
74067935|NCT01743677|147687264|SUPERIORITY||Least Squares Mean Difference|1.08|||||TWO_SIDED|90.0|-0.78|2.93||||||||2.93|-0.78|
74067936|NCT01743677|147687265|SUPERIORITY||Least Squares Mean Difference|0.86|||||TWO_SIDED|90.0|-1.0|2.71||||||||2.71|-1.00|
74067937|NCT01743677|147687266|SUPERIORITY||Least Squares Mean Difference|1.15|||||TWO_SIDED|90.0|-0.71|3.0||||||||3.00|-0.71|
74067938|NCT01743677|147687267|SUPERIORITY||Least Squares Mean Difference|2.15|||||TWO_SIDED|90.0|0.29|4.0||||||||4.00|0.29|
74067939|NCT01743677|147687268|SUPERIORITY||Least Squares Mean Difference|1.35|||||TWO_SIDED|90.0|-0.5|3.21||||||||3.21|-0.50|
74067940|NCT01743677|147687269|SUPERIORITY||Least Squares Mean Difference|11.29|||||TWO_SIDED|90.0|9.62|12.96||||||||12.96|9.62|
74067941|NCT01743677|147687270|SUPERIORITY||Least Squares Mean Difference|0.16|||||TWO_SIDED|90.0|-2.11|2.44||||||0.25 hour post-dose||2.44|-2.11|
74067942|NCT01743677|147687270|SUPERIORITY||Least Squares Mean Difference|1.78|||||TWO_SIDED|90.0|-0.49|4.06||||||0.5 hour post-dose||4.06|-0.49|
74067943|NCT01743677|147687270|SUPERIORITY||Least Squares Mean Difference|2.99|||||TWO_SIDED|90.0|0.71|5.26||||||1 hour post-dose||5.26|0.71|
74067944|NCT01743677|147687270|SUPERIORITY||Least Squares Mean Difference|1.08|||||TWO_SIDED|90.0|-1.19|3.36||||||2 hours post-dose||3.36|-1.19|
74067945|NCT01743677|147687270|SUPERIORITY||Least Squares Mean Difference|2.16|||||TWO_SIDED|90.0|-0.11|4.44||||||4 hours post-dose||4.44|-0.11|
74067946|NCT01743677|147687270|SUPERIORITY||Least Squares Mean Difference|0.05|||||TWO_SIDED|90.0|-2.22|2.33||||||8 hours post-dose||2.33|-2.22|
74067947|NCT01743677|147687270|SUPERIORITY||Least Squares Mean Difference|0.49|||||TWO_SIDED|90.0|-1.79|2.76||||||12 hours post-dose||2.76|-1.79|
74067948|NCT01743677|147687270|SUPERIORITY||Least Squares Mean Difference|2.1|||||TWO_SIDED|90.0|-0.17|4.38||||||16 hours post-dose||4.38|-0.17|
74067949|NCT01743677|147687270|SUPERIORITY||Least Squares Mean Difference|0.79|||||TWO_SIDED|90.0|-1.49|3.06||||||24 hours post-dose||3.06|-1.49|
74067950|NCT01715415|147687281|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic peg-interferon/ribavirin (pegIFN/RBV) treatment-experienced subjects administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 60% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 70% to achieve superiority.|Percentage of Participants with SVR12|96.3|||||TWO_SIDED|95.0|94.1|98.4|||||95% CI calculated using the normal approximation to the binomial distribution. In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and numbered secondary efficacy endpoints.|With a sample size of 300 subjects and assuming that 85% of the subjects in Arm A will achieve sustained virologic response (SVR) 12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 60% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 70% (based on the normal approximation of a single binomial proportion).||98.4|94.1|
74067951|NCT01715415|147687282|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and the first 3 secondary endpoints in the order numbered below.|Fisher Exact|||||||<0.001
74067952|NCT01715415|147687283|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 65% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.0|||||TWO_SIDED|95.0|93.0|98.9|||||95% CI calculated using the normal approximation to the binomial distribution.|||98.9|93.0|
74067953|NCT01715415|147687284|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 77% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.7|||||TWO_SIDED|95.0|93.6|99.9||||||||99.9|93.6|
74067954|NCT03586830|147687320|SUPERIORITY||Difference of least square (LS) means|-4.56|STANDARD_ERROR_OF_MEAN|0.757|<|0.001|TWO_SIDED|95.0|-6.05|-3.06|||Hochberg Approach|||||-3.06|-6.05|<.001
74067955|NCT03586830|147687320|SUPERIORITY||Difference of LS Means|-5.85|STANDARD_ERROR_OF_MEAN|0.755|<|0.001|TWO_SIDED|95.0|-7.34|-4.36|||Hochberg Approach|||||-4.36|-7.34|<.001
74067956|NCT03586830|147687320|SUPERIORITY||Difference of LS Means|-7.23|STANDARD_ERROR_OF_MEAN|0.748|<|0.001|TWO_SIDED|95.0|-8.7|-5.75|||Hochberg Approach|||||-5.75|-8.70|<.001
74067957|NCT04578548|147687324|SUPERIORITY||Geometric Mean Difference|-0.91||||0.606|TWO_SIDED|95.0|-4.34|2.64|||Random coefficient regression model|||Based on a random coefficient regression model (linear slope model) on htTKV log-transformed values with time (in weeks) as a continuous variable, treatment, time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.||2.64|-4.34|0.606
74067958|NCT04578548|147687326|SUPERIORITY||Least-squares mean difference|-2.31||||0.171|TWO_SIDED|95.0|-5.64|1.02|||Random coefficient regression model|||Least-squares mean difference (95% CI) from a random coefficient regression model (linear slope model) on eGFR values with time (in weeks) as a continuous variable, the time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.||1.02|-5.64|0.171
74067959|NCT00395083|147687330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.62|TWO_SIDED|95.0|0.7|1.8|||Log Rank|||||1.80|0.70|0.62
74067960|NCT00395083|147687331|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.62|TWO_SIDED|95.0|0.7|1.8|||Regression, Cox|||||1.80|0.70|0.62
74067961|NCT00395083|147687332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.0||||0.003|TWO_SIDED|95.0|1.46|6.17|||Regression, Cox|||||6.17|1.46|0.003
74067962|NCT00395083|147687333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.0||||0.002|TWO_SIDED|95.0|1.46|6.17|||Log Rank|||||6.17|1.46|0.002
74067963|NCT00972153|147687334|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.||||<0.001
74067964|NCT00972153|147687335|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.||||<0.001
74067965|NCT04136626|147687336|SUPERIORITY||Mean Difference (Final Values)|-2.0475||||0.0871|TWO_SIDED|95.0|-4.3977|0.3027||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in Y-BOCS total scores between the treatment groups at endpoint (week 12).||0.3027|-4.3977|0.0871
73883381|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||<|0.0001|TWO_SIDED|95.0|1.476|2.464|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.464|1.476|<.0001
73883382|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.983|||<|0.0001|TWO_SIDED|95.0|1.491|2.475|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.475|1.491|<.0001
74067966|NCT04136626|147687336|SUPERIORITY||Difference in the amount of change|-3.4385||||0.0036|TWO_SIDED|95.0|-5.7394|-1.1376||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment Y-BOCS total scores between the treatment groups.||-1.1376|-5.7394|0.0036
74067967|NCT04136626|147687337|SUPERIORITY||Mean Difference (Final Values)|-0.8743||||0.3616|TWO_SIDED|95.0|-2.7666|1.0181||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in depression severity (QIDS-SR total scores) between the treatment groups at endpoint (week 12).||1.0181|-2.7666|0.3616
74067968|NCT04136626|147687337|SUPERIORITY||Difference in the amount of change|-1.3076||||0.1973|TWO_SIDED|95.0|-3.3014|0.6862||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment depression severity (QIDS-SR total scores) between the treatment groups.||0.6862|-3.3014|0.1973
74067969|NCT04136626|147687338|SUPERIORITY||Mean Difference (Final Values)|-2.7992||||0.1289|TWO_SIDED|95.0|-6.4246|0.8262||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in functional impairment (WSAS total scores) between the treatment groups at endpoint (week 12).||0.8262|-6.4246|0.1289
74067970|NCT04136626|147687338|SUPERIORITY||Difference in the amount of change|-4.5704||||0.0137|TWO_SIDED|95.0|-8.1939|-0.9468||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment functional impairment (WSAS total scores) between the treatment groups.||-0.9468|-8.1939|0.0137
74067971|NCT04136626|147687339|SUPERIORITY||Mean Difference (Final Values)|4.3953||||0.1796|TWO_SIDED|95.0|-2.0543|10.8448||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in quality of life (Q-LES-Q-SF percentage scores) between the treatment groups at endpoint (week 12).||10.8448|-2.0543|0.1796
74067972|NCT04136626|147687339|SUPERIORITY||Difference in the amount of change|6.7962||||0.04|TWO_SIDED|95.0|0.314|13.2785||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment quality of life (Q-LES-Q-SF percentage scores) between the treatment groups.||13.2785|0.3140|0.0400
74067973|NCT00982410|147687366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6489|STANDARD_ERROR_OF_MEAN|0.29|<|0.05|TWO_SIDED|95.0|-1.2255|-0.0722|||Mixed Models Analysis|Adjusted for baseline NRS-1 pain level. Time interval and therapy session block were utilized to model the variance.|EUC (Arm 2) was referent. Estimation parameter = value for Cognitive Behavior Treatment group minus value for Educational Support group.|Ho: There was no difference in average pain level across the follow-up period, between CBT group and Educational support group.||-0.07220|-1.2255|<0.05
74067974|NCT00982410|147687367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.05|TWO_SIDED|95.0|0.034|0.466|||Mixed Models Analysis|Adjusted for baseline WHY MPI General Activity score. Time interval and therapy session block were utilized to model the variance.|Education Support group was referent. Mean difference = value for CBT group minus value for Educational Support group.|||0.466|0.034|<0.05
74067975|NCT00982410|147687368|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline #days of alcohol use. Time interval and therapy session block were utilized to model the variance.||||||<0.01
74067976|NCT00982410|147687369|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline #days illicit drug use. Time interval and therapy session block were utilized to model the variance. EUC group was referent.||||||>0.05
73888314|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|20.7|||<|0.0001|TWO_SIDED|95.0|13.1|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.2|13.1|<0.0001
73883383|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.005|||<|0.0001|TWO_SIDED|95.0|1.51|2.501|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.501|1.510|<.0001
73888315|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|||<|0.0001|TWO_SIDED|95.0|11.8|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||26.8|11.8|<0.0001
74067977|NCT00982410|147687370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.66|||>|0.05|TWO_SIDED|95.0|-5.0|14.32|||Mixed Models Analysis|Adjusted for baseline pain tolerance. Time interval and therapy session block were utilized to model the variance.|Educational Support group = referent. Estimation parameter = CBT group minus EUC group, adjusted for BL pain tolerance. Cold tolerance distribution had ceiling and floor effects; and, \~20% of participants refused cold tolerance task in follow-up.|||14.32|-5.00|>0.05
74067978|NCT00982410|147687371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.28|||<|0.005|TWO_SIDED|95.0|3.93|16.63|||Mixed Models Analysis|Adjusted for baseline CPSS PSE score. Time interval and therapy session block were utilized to model the variance. EUC group was referent.|Adjusted for baseline CPSS PSE score. EUC group was referent. Mean difference = value for CBT minus value for Educational Support group.|||16.63|3.93|<0.005
74067979|NCT02004847|147687377|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment (week 12) of the target plaque compared to the control plaque.||||0.0005
74067980|NCT02004847|147687378|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment during the attack period (week 4) of the target plaque compared to the control plaque.||||0.0036
74067981|NCT02004847|147687379|SUPERIORITY_OR_OTHER|||||||0.3075|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from end of treatment (week 12, visit 7) to end of follow up (week 16, visit 8) of the target plaque compared to the control plaque.||||0.3075
74067982|NCT02004847|147687380|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 4 of the target plaque compared to the control plaque.||||0.0140
74067983|NCT02004847|147687380|SUPERIORITY_OR_OTHER|||||||0.0064|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 12 of the target plaque compared to the control plaque.||||0.0064
74067984|NCT02004847|147687380|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 16 of the target plaque compared to the control plaque.||||0.1020
74067985|NCT02034799|147687393|NON_INFERIORITY_OR_EQUIVALENCE|The assumed proportion of success for SOC is 0.95 and the proportion of success for the Bioseal group at which the power is calculated is 0.95. A sample size of 112 subjects per group achieves 80% power to detect the non-inferiority margin difference between the group proportions of -0.10. One-sided significance level of 0.025 was used. Using drop-out rate of 10%, 125 subjects per treatment group were randomized for a total of 250 subjects.|Risk Difference (RD)|0.0781|||||TWO_SIDED|95.0|-0.048|0.199||||||H0: Delta \</= -0.1 HA: Delta \> -0.1 Delta is difference in proportion of successes between Bioseal and SOC gropus (Bioseal minus SOC). Success is defined as hemostasis at the TBS at 6 minutes following treatment application||0.199|-0.048|
74067986|NCT05321810|147687402|OTHER|||||||0.016|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.016
74067987|NCT05321810|147687407|OTHER||Hazard Ratio (HR)|0.812||||0.013|TWO_SIDED|95.0|0.69|0.957|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.957|0.690|0.013
74067988|NCT05321810|147687413|OTHER|||||||0.002|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.002
74067989|NCT05321810|147687416|OTHER||||||<|0.001|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||<0.001
74067990|NCT05321810|147687417|OTHER||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.42|0.773|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.773|0.420|<0.001
74067991|NCT05321810|147687419|OTHER|||||||0.35|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.350
74067992|NCT05321810|147687420|OTHER||Hazard Ratio (HR)|1.155||||0.324|TWO_SIDED|95.0|0.867|1.54|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.540|0.867|0.324
73883384|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.018|||<|0.0001|TWO_SIDED|95.0|1.517|2.519|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.519|1.517|<.0001
74067993|NCT05321810|147687422|OTHER|||||||0.111|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.111
74067994|NCT05321810|147687423|OTHER||Hazard Ratio (HR)|0.866||||0.1|TWO_SIDED|95.0|0.73|1.028|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.028|0.730|0.100
74067995|NCT05321810|147687425|OTHER|||||||0.979|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.979
74067996|NCT05321810|147687426|OTHER||Hazard Ratio (HR)|1.002||||0.978|TWO_SIDED|95.0|0.854|1.177|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.177|0.854|0.978
74067997|NCT05321810|147687428|OTHER||||||<|0.001|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||<0.001
74067998|NCT05321810|147687429|OTHER||Hazard Ratio (HR)|0.428|||<|0.001|TWO_SIDED|95.0|0.263|0.697|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.697|0.263|<0.001
74067999|NCT05321810|147687433|OTHER||Hazard Ratio (HR)|0.727||||0.001|TWO_SIDED|95.0|0.599|0.881|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.881|0.599|0.001
74068000|NCT00434161|147687439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.679||||0.188|TWO_SIDED|97.5|0.351|1.313||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.||1.313|0.351|0.188
74068001|NCT00434161|147687439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.242||||0.468|TWO_SIDED|97.5|0.635|2.431||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.||2.431|0.635|0.468
73883385|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|||<|0.0001|TWO_SIDED|95.0|1.522|2.559|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.559|1.522|<.0001
74068002|NCT00434161|147687440|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.262||||0.245|TWO_SIDED|97.5|-4.303|30.828||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel|||||30.828|-4.303|0.245
74068003|NCT00434161|147687440|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.014||||0.806|TWO_SIDED|97.5|-20.519|16.491||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel|||||16.491|-20.519|0.806
74068004|NCT00434161|147687441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.409|STANDARD_DEVIATION|6.82||0.095|TWO_SIDED|97.5|0.07|4.748||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||A type I error rate was protected by using the Hochberg procedure to adjust for multiple testing. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.||4.748|0.070|0.095
74068005|NCT00434161|147687441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|STANDARD_DEVIATION|6.13||0.806|TWO_SIDED|97.5|-2.575|2.15||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||||2.150|-2.575|0.806
74068006|NCT00434161|147687442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.436||||0.142|TWO_SIDED|97.5|-1.542|32.415||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||For the secondary endpoints, the type I error rate was protected by using the Hochberg procedure to adjust for multiple testing16. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.||32.415|-1.542|0.142
74068007|NCT00434161|147687442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.331||||0.806|TWO_SIDED|97.5|-11.82|22.482||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||||22.482|-11.820|0.806
74068008|NCT00434161|147687443|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.88|||||TWO_SIDED|95.0|-21.669|33.43||According to statistical analysis plan it was not planned to calculate any P-Value.||||||33.43|-21.669|
74068009|NCT00434161|147687445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.023|||||TWO_SIDED|95.0|-0.134|0.181||||||||0.181|-0.134|
74068010|NCT00434161|147687446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||||TWO_SIDED|95.0|-0.138|0.26||||||||0.260|-0.138|
74068011|NCT00434161|147687447|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.689|||||TWO_SIDED|95.0|-21.641|14.264||||||||14.264|-21.641|
74068012|NCT00434161|147687448|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.951|||||TWO_SIDED|95.0|-0.679|12.58||||||||12.580|-0.679|
74068013|NCT00434161|147687450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.192|TWO_SIDED|95.0|0.33|1.26|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.26|0.33|0.192
74068014|NCT00434161|147687451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.417|||||TWO_SIDED|95.0|-11.086|45.919||||||||45.919|-11.086|
74068015|NCT00434161|147687452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.236|TWO_SIDED|95.0|0.55|1.16|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.16|0.55|0.236
74068016|NCT00434161|147687453|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.84||||0.372|TWO_SIDED|95.0|0.58|1.23|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.23|0.58|0.372
74068017|NCT03342898|147687455|NON_INFERIORITY|Non-inferiority of the immune response was performed only between YF + TDV (Group 3) and YF + Placebo (Group 1) at Day 120. Non-inferiority between Group 3 and Group 1 was concluded if the upper bound of the 95% CI for the seroprotection rate difference (Group 1 - Group 3) was less than 5%.|Seroprotection Rate Difference|0.4|||||TWO_SIDED|95.0|-1.85|2.69|||||The Newcombe score method was used to compute the 95% CI of the seroprotection rate difference.|||2.69|-1.85|
74068018|NCT03342898|147687456|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.6|||||TWO_SIDED|95.0|1.19|2.22|||||Analysis of variance (ANOVA) model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-1||2.22|1.19|
73883386|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.053|||<|0.0001|TWO_SIDED|95.0|1.522|2.584|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.584|1.522|<.0001
74068019|NCT03342898|147687456|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.3||||||95.0|1.03|1.75|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-2||1.75|1.03|
74068020|NCT03342898|147687456|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.3||||||95.0|0.99|1.61|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-3||1.61|0.99|
74068021|NCT03342898|147687456|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.89|1.46|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-4||1.46|0.89|
73883387|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.075|||<|0.0001|TWO_SIDED|95.0|1.515|2.635|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.635|1.515|<.0001
74068022|NCT03342898|147687460|NON_INFERIORITY|Non-inferiority of the immune response was performed only between YF + TDV (Group 3) and YF + Placebo (Group 1) at Day 30. Non-inferiority between Group 3 and Group 1 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 1/Group 3) was less than 2.0.|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.26|||||ANOVA model was used for analyses, including the log-transformed value of titer as the dependent variable and trial group as a factor.|||1.26|0.77|
74068023|NCT01267266|147687467|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Log Rank|||||||0.20
74068024|NCT01907087|147687499|OTHER|Inference is by an exact binomial test of the null hypothesis H0: Prob(response) \<= 0.50 vs. the alternative hypothesis H1: Prob(response) \> 0.50, where Prob(response) denotes the population probability of a response. The confidence interval is an exact interval with significance level α=0.05.|Proportion of responders|0.87||||0.0002|TWO_SIDED|95.0|0.66|0.97|||exact binomial test|||"Responder Analysis using ITT Population: Proportion of Subjects without an Unreversed Two-point Decline or Score of 0 in ML Scale Score at 48 Weeks.~A 'response' is defined as the absence of an unreversed two-point decline or score of 0 in the 0-to-6 point CLN2 score at 48 weeks."||0.97|0.66|0.0002
74068025|NCT01907087|147687499|OTHER|"Subject rate of decline per 48 weeks is estimated: (baseline CLN2 score - last CLN2 score)/(time elapsed in units of 48 weeks).~P-value computed as a two-sided t-test for the hypothesis H0: Rate=2.0 points lost/48 weeks vs. H1: Rate not equal 2.0 points lost/48 weeks."|Slope|0.4|STANDARD_DEVIATION|0.809|<|0.0001|TWO_SIDED|95.0|0.05|0.75|||t-test, 2 sided|||Slopes Analysis using ITT Population: Estimated Rate of Decline (300 mg Dosing Period).||0.75|0.05|<0.0001
74068026|NCT02884206|147687533|NON_INFERIORITY|To demonstrate non-inferiority that LCZ696 does not lead to a relevant decrease in cognition compared to valsartan at year 3, the lower bound of 95% CI does not include the pre-specified non-inferiority (NI) boundary (Cohen's D) of -0.3. An effect size of 0.3 in Cohen's D is generally considered as small.|LSM|-0.018||||0.7363|TWO_SIDED|95.0|-0.123|0.087|||ANCOVA|||Repeated measure ANCOVA|Cohen's D: -0.0277, 95% CI: -0.1101 to 0.0778|0.0870|-0.1230|0.7363
74068027|NCT02884206|147687534|NON_INFERIORITY|To show that the point estimate of SUVr difference in mean change over 3 years is in favor of LCZ696 and the non-inferiority is demonstrated, with the upper bound of the 95% CI excluding the NI boundary of 0.01.|Least Squares Mean|-0.0292||||0.0579|TWO_SIDED|95.0|-0.0593|0.001|||ANCOVA|||Multiple Imputation ANCOVA in Global cortical composite||0.0010|-0.0593|0.0579
74068028|NCT02884206|147687535|SUPERIORITY||Least Squares Mean|0.0007||||0.9916|TWO_SIDED|95.0|-0.1339|0.1353|||ANCOVA|||Repeated measure ANCOVA for memory domain|Cohen's D: 0.0009; 95% CI: -0.0912 to 0.0922|0.1353|-0.1339|0.9916
74068029|NCT02884206|147687535|SUPERIORITY||Least Squares Mean|0.0327||||0.6348|TWO_SIDED|95.0|-0.1024|0.1677|||ANCOVA|||Repeated measure ANCOVA for executive function domain|Cohen's D: 0.0391, 95% CI: -0.0727 to 0.1192|0.1677|-0.1024|0.6348
73883388|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.088|||<|0.0001|TWO_SIDED|95.0|1.509|2.667|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.667|1.509|<.0001
74068030|NCT02884206|147687535|SUPERIORITY||Least Squares Mean|-0.1042||||0.2403|TWO_SIDED|95.0|-0.2783|0.07|||ANCOVA|||Repeated measure ANCOVA for attention domain|Cohen's D: -0.0967, 95% CI: -0.1542 to 0.0387|0.0700|-0.2783|0.2403
74068031|NCT02884206|147687536|SUPERIORITY||Least Squares Mean|-0.1105||||0.7081|TWO_SIDED|95.0|-0.6906|0.4696|||ANCOVA|||Repeated measure ANCOVA|Cohen's D: -0.0308, 95% CI: -0.1208 to 0.0820|0.4696|-0.6906|0.7081
74068032|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.74|||||ONE_SIDED||||||||GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"||||
74068033|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.76|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068034|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|2.15|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068035|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.0|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068036|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.52|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068037|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.48|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068038|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|2.48|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068039|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.0|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068040|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI GMT ratio|1.23|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068041|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.12|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068042|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.46|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068043|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.61|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068044|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.39|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068045|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.1|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068046|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.65|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
73888316|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|284.3|||<|0.0001|TWO_SIDED|95.0|232.9|335.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||335.8|232.9|<0.0001
74068047|NCT01492582|147687538|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|-0.44|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
74068048|NCT01492582|147687539|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||<0.001
74068049|NCT01492582|147687539|SUPERIORITY|||||||0.03|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||0.03
74068050|NCT01492582|147687539|SUPERIORITY|||||||0.48|||||||Chi-squared, Corrected|||Systemic - Dizziness Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||0.48
74068051|NCT01492582|147687539|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea; Systemic - Fatigue Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||<0.001
74068052|NCT01492582|147687539|SUPERIORITY|||||||0.07|||||||Chi-squared, Corrected|||Systemic - Headache Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.07
74068053|NCT01492582|147687539|SUPERIORITY|||||||0.28|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.28
74068054|NCT01492582|147687539|SUPERIORITY|||||||0.45|||||||Fisher Exact|||Systemic - Dizziness Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.45
74068055|NCT01172600|147687569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.84|TWO_SIDED|95.0|-1.43|1.17|||Regression, Linear|The analysis adjusted for VAS at baseline (before 1st block), number of epidural blocks received, and imbalanced baseline variables.|This is an intention- to-treat analysis. We assigned missing outcomes to 10 patients.|||1.17|-1.43|0.84
74068056|NCT01172600|147687569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.12|TWO_SIDED|95.0|-2.34|0.28|||Regression, Linear||This is a per-protocol analysis, using 68 patients with completed data.|||0.28|-2.34|0.12
74068057|NCT01172600|147687570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.63|TWO_SIDED|98.3|-1.8|1.21|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.|||1.21|-1.80|0.63
74068058|NCT01172600|147687571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.16|TWO_SIDED|98.3|-3.05|0.82|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.|||0.82|-3.05|0.16
74068059|NCT04081337|147687601|SUPERIORITY||LS Mean Difference|19.68||||0.5733|TWO_SIDED|95.0|-50.36|89.72|||ANCOVA|||||89.72|-50.36|0.5733
74068060|NCT04081337|147687602|SUPERIORITY||LS Mean Difference|-855.94|||<|0.0001|TWO_SIDED|95.0|-1090.87|-621.02|||ANCOVA|||||-621.02|-1090.87|<0.0001
74068061|NCT04081337|147687603|SUPERIORITY||LS Mean Difference|-3.22||||0.9481|TWO_SIDED|95.0|-102.65|96.2|||ANCOVA|||||96.20|-102.65|0.9481
74068062|NCT04081337|147687604|SUPERIORITY||LS Mean Difference|-0.034|||<|0.0001|TWO_SIDED|95.0|-0.051|-0.018|||ANCOVA|||||-0.018|-0.051|<0.0001
74068063|NCT04081337|147687605|SUPERIORITY||LS Mean difference|-0.028||||0.0031|TWO_SIDED|95.0|-0.045|-0.01|||ANCOVA|||||-0.010|-0.045|0.0031
74068064|NCT04081337|147687606|SUPERIORITY||LS Mean difference|251.89||||0.0004|TWO_SIDED|95.0|119.09|384.69|||ANCOVA|||||384.69|119.09|0.0004
74068065|NCT04081337|147687607|SUPERIORITY||LS Mean difference|-6.87||||0.0005|TWO_SIDED|95.0|-10.51|-3.22|||ANCOVA|||For Adjusted protein oxidation||-3.22|-10.51|0.0005
74068066|NCT04081337|147687607|SUPERIORITY||LS Mean difference|14.48|||<|0.0001|TWO_SIDED|95.0|8.02|20.93|||ANCOVA|||For Adjusted fat oxidation||20.93|8.02|<0.0001
74068067|NCT04081337|147687607|SUPERIORITY||LS Mean difference|-26.64||||0.0001|TWO_SIDED|95.0|-39.46|-13.83|||ANCOVA|||Adjusted carbohydrate oxidation||-13.83|-39.46|0.0001
74068068|NCT04081337|147687608|SUPERIORITY||LS Mean difference|-8.47|||<|0.0001|TWO_SIDED|95.0|-11.04|-5.9|||Mixed Models Analysis|||||-5.90|-11.04|<0.0001
74068069|NCT04081337|147687609|SUPERIORITY||LS Mean difference|-4.08|||<|0.0001|TWO_SIDED|95.0|-5.12|-3.05|||Mixed Models Analysis|||||-3.05|-5.12|<0.0001
74068070|NCT04081337|147687610|SUPERIORITY||LS Mean difference|-5.08|||<|0.0001|TWO_SIDED|95.0|-6.93|-3.22|||ANCOVA|||||-3.22|-6.93|<0.0001
74068071|NCT04081337|147687611|SUPERIORITY||LS Mean Difference|-1.14||||0.0304|TWO_SIDED|95.0|-2.16|-0.11|||ANCOVA|||||-0.11|-2.16|0.0304
74068072|NCT04081337|147687612|SUPERIORITY||LS Mean difference|-1.83|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.06|||ANCOVA|||For Triglyceride||-1.06|-2.60|<0.0001
74068073|NCT04081337|147687612|SUPERIORITY||LS Mean difference|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.48|||ANCOVA|||For VLDL||-0.48|-1.19|<0.0001
74068074|NCT04081337|147687612|SUPERIORITY||LS Mean difference|-0.53||||0.0436|TWO_SIDED|95.0|-1.05|-0.02|||ANCOVA|||For HDL||-0.02|-1.05|0.0436
74068075|NCT04081337|147687612|SUPERIORITY||LS Mean Difference|0.45||||0.0002|TWO_SIDED|95.0|0.23|0.66|||ANCOVA|||For Free fatty acid||0.66|0.23|0.0002
74068076|NCT04081337|147687613|SUPERIORITY||LS Mean Difference|0.03||||0.8762|TWO_SIDED|95.0|-0.34|0.4|||ANCOVA|||||0.40|-0.34|0.8762
74068077|NCT04081337|147687614|SUPERIORITY||LS Mean difference|3.49||||0.0126|TWO_SIDED|95.0|0.79|6.19|||ANCOVA|||||6.19|0.79|0.0126
74068078|NCT04081337|147687615|SUPERIORITY||LS Mean Difference|-1.26||||0.0222|TWO_SIDED|95.0|-2.34|-0.19|||ANCOVA|||||-0.19|-2.34|0.0222
74068079|NCT04081337|147687616|SUPERIORITY||LS Mean difference|-0.36|||<|0.0001|TWO_SIDED|95.0|-0.48|-0.23|||ANCOVA|||||-0.23|-0.48|<0.0001
74068080|NCT00829413|147687617|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|37.8|||<|0.0001|TWO_SIDED|95.0|27.4|48.2|||McNemar|||||48.2|27.4|<.0001
74068081|NCT00829413|147687617|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|40.3|||<|0.0001|TWO_SIDED|95.0|30.4|50.3|||McNemar|||||50.3|30.4|<.0001
74068082|NCT00829413|147687617|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|75.6|||<|0.0001|TWO_SIDED|95.0|67.9|83.3|||McNemar|||||83.3|67.9|<.0001
74068083|NCT00829413|147687618|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|7.9||||0.138|TWO_SIDED|95.0|-2.4|18.2|||McNemar|||||18.2|-2.4|0.1380
74068084|NCT00829413|147687618|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|28.6|||<|0.0001|TWO_SIDED|95.0|19.7|37.5|||McNemar|||||37.5|19.7|<.0001
74068085|NCT00829413|147687618|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|50.7|||<|0.0001|TWO_SIDED|95.0|42.0|59.5|||McNemar|||||59.5|42.0|<.0001
74068086|NCT00829413|147687619|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|21.6|||<|0.0001|TWO_SIDED|95.0|14.1|29.2|||McNemar|||||29.2|14.1|<.0001
74068087|NCT00829413|147687619|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|34.0|||<|0.0001|TWO_SIDED|95.0|27.3|40.7|||McNemar|||||40.7|27.3|<.0001
74068088|NCT00829413|147687619|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|75.6|||<|0.0001|TWO_SIDED|95.0|67.9|83.3|||McNemar|||||83.3|67.9|<.0001
74068089|NCT00829413|147687620|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
74068090|NCT00829413|147687620|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
74068091|NCT00829413|147687620|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
74068092|NCT00829413|147687621|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
74068093|NCT00829413|147687621|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
74068094|NCT00829413|147687621|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
74068095|NCT01578707|147687625|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
74068096|NCT01578707|147687626|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
73888317|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|31.2||||0.2336|TWO_SIDED|95.0|-20.4|82.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||82.8|-20.4|0.2336
74068097|NCT01578707|147687627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1653|||||||Log Rank|||||||0.1653
74068098|NCT02927847|147687657|OTHER||t-value|0.138||||0.891|TWO_SIDED||||||t-test, 2 sided|||||||0.891
74068099|NCT02927847|147687658|OTHER||t-value|-0.575||||0.571|TWO_SIDED||||||t-test, 2 sided|||||||0.571
74068100|NCT02927847|147687659|OTHER||Odds Ratio (OR)|1.17||||0.739|TWO_SIDED||||||Regression, Cox|||||||0.739
74068101|NCT00723554|147687681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|||<|0.001|TWO_SIDED|95.0|-6.9|-5.4|||t-test, 2 sided|||Comparison of the change in average inhalation times from Period I (PD-6) to Period II (PD-15)||-5.4|-6.9|<0.001
74068102|NCT00723554|147687685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.59|TWO_SIDED|95.0|-1.0|0.6|||t-test, 2 sided|||Comparison of the change in average number of days of dosing from Period I (PD-6) to Period II (PD-15)||0.6|-1.0|0.59
74068103|NCT00723554|147687689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||<|0.001|TWO_SIDED|95.0|0.2|0.7|||t-test, 2 sided|||Comparison of the change in average number of daily doses from Period I (PD-6) to Period II (PD-15)||0.7|0.2|<0.001
74068104|NCT00723554|147687693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.0|||<|0.0001|TWO_SIDED|95.0|6.5|15.6|||t-test, 2 sided|||Comparison of the change in percentage of complete doses delivered from Period I (PD-6) to Period II (PD-15)||15.6|6.5|<0.0001
74068105|NCT03255031|147687704|SUPERIORITY|||||||0.067||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||||0.067
74068106|NCT03255031|147687705|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||||0.004
74068107|NCT03151499|147687714|OTHER||Geometric mean (gMean) ratio (%)|7.8|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|5.74|10.601|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|The main focus is on estimation, therefore no hypothesis was tested. The statistical analysis model for the primary endpoints is an ANOVA (analysis of variance). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||10.601|5.740|
74068108|NCT03151499|147687715|OTHER||Geometric mean (gMean) ratio (%)|9.77|STANDARD_ERROR_OF_MEAN|1.232|||TWO_SIDED|90.0|6.767|14.098|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|The main focus is on estimation, therefore no hypothesis was tested. The statistical analysis model for the primary endpoints is an ANOVA (analysis of variance). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||14.098|6.767|
74068109|NCT03151499|147687716|OTHER||Geometric mean (gMean) ratio (%)|8.23|STANDARD_ERROR_OF_MEAN|1.187|||TWO_SIDED|90.0|6.081|11.126|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|Since the main focus is on estimation and not testing, therefore no hypothesis was tested.The statistical analysis model is an ANOVA (analysis of variance) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||11.126|6.081|
74068110|NCT03563027|147687718|SUPERIORITY||Mean Difference (Net)|433.0||||0.81|TWO_SIDED|95.0|-337.0|1203.0|||Regression, Linear|||||1203|-337|.81
74068111|NCT03563027|147687718|SUPERIORITY||Mean Difference (Net)|1224.0||||0.005|TWO_SIDED|95.0|451.0|1996.0|||Regression, Linear|||||1996|451|.005
74068112|NCT03563027|147687719|SUPERIORITY||Mean Difference (Net)|-160.0||||0.92|TWO_SIDED|95.0|-983.0|663.0|||Regression, Linear|||||663|-983|.92
74068113|NCT03563027|147687719|SUPERIORITY||Mean Difference (Net)|564.0||||0.37|TWO_SIDED|95.0|-261.0|1389.0|||Regression, Linear|||||1389|-261|.37
74068114|NCT03563027|147687720|SUPERIORITY||Median Difference (Net)|0.21|||<|0.001|TWO_SIDED|95.0|0.18|0.24|||Regression, Linear|||||.24|.18|<.001
74068115|NCT03563027|147687720|SUPERIORITY||Mean Difference (Net)|0.34|||<|0.001|TWO_SIDED|95.0|0.31|0.37|||Regression, Linear|||||.37|.31|<.001
74068116|NCT03563027|147687721|SUPERIORITY||Mean Difference (Net)|0.09|||<|0.001|TWO_SIDED|95.0|0.06|0.1|||Regression, Linear|||||0.1|.06|<.001
74068117|NCT03563027|147687721|SUPERIORITY||Median Difference (Net)|0.18|||<|0.001|TWO_SIDED|95.0|0.15|0.2|||Regression, Linear|||||.20|.15|<.001
74068118|NCT00415532|147687722|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.172|||<|0.0001||95.0|0.084|0.352||Significant level is set at 0.05|Cochran-Mantel-Haenszel|||||0.352|0.084|<0.0001
74068119|NCT00415532|147687723|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.307||||0.0005||95.0|0.154|0.611||Significant level is set at 0.05|Cochran-Mantel-Haenszel|||||0.611|0.154|0.0005
74068120|NCT00415532|147687726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0133
74068121|NCT00415532|147687727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3434||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.3434
74068122|NCT00415532|147687728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0076||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0076
74068123|NCT00415532|147687729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0246||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0246
74068124|NCT02040766|147687734|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.0063|TWO_SIDED|95.0|0.796|4.821||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (inhaled corticosteroid (ICS) or non-corticosteroid (NCS) therapy) at the time of screening visit, during the run-in period, and during treatment.||4.821|0.796|0.0063
74068125|NCT02040766|147687734|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.5332|TWO_SIDED|95.0|-1.354|2.614||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.||2.614|-1.354|0.5332
74068126|NCT02040766|147687734|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.3649|TWO_SIDED|95.0|-1.077|2.924||significance at 0.05|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.||2.924|-1.077|0.3649
74068127|NCT02040766|147687734|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.2823|TWO_SIDED|95.0|-0.902|3.088|||ANCOVA|||||3.088|-0.902|0.2823
74068128|NCT02040766|147687735|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.0001|TWO_SIDED|95.0|5.58|17.06|||Mixed Models Analysis|||||17.06|5.58|0.0001
74068129|NCT02040766|147687735|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.0041|TWO_SIDED|95.0|2.71|14.24|||Mixed Models Analysis|||||14.24|2.71|0.0041
74068130|NCT02040766|147687735|SUPERIORITY||Mean Difference (Final Values)|7.6||||0.0103|TWO_SIDED|95.0|1.79|13.35|||Mixed Models Analysis|||||13.35|1.79|0.0103
74068131|NCT02040766|147687735|SUPERIORITY||Mean Difference (Final Values)|6.5||||0.0278|TWO_SIDED|95.0|0.71|12.23|||Mixed Models Analysis|||||12.23|0.71|0.0278
73883389|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11|||<|0.0001|TWO_SIDED|95.0|1.494|2.727|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.727|1.494|<.0001
74068132|NCT02040766|147687736|SUPERIORITY||Mean Difference (Final Values)|11.7|||<|0.0001|TWO_SIDED|95.0|5.96|17.45|||Mixed Models Analysis|||||17.45|5.96|<0.0001
74068133|NCT02040766|147687736|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.0007|TWO_SIDED|95.0|4.2|15.76|||Mixed Models Analysis|||||15.76|4.20|0.0007
74068134|NCT02040766|147687736|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.0008|TWO_SIDED|95.0|4.11|15.68|||Mixed Models Analysis|||||15.68|4.11|0.0008
74068135|NCT02040766|147687736|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.0031|TWO_SIDED|95.0|2.95|14.49|||Mixed Models Analysis|||||14.49|2.95|0.0031
74068136|NCT02040766|147687737|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0002|TWO_SIDED|95.0|-0.548|-0.174|||Mixed Models Analysis|||||-0.174|-0.548|0.0002
74068137|NCT02040766|147687737|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.132|TWO_SIDED|95.0|-0.331|0.044|||Mixed Models Analysis|||||0.044|-0.331|0.1320
74068138|NCT02040766|147687737|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.5866|TWO_SIDED|95.0|-0.24|0.136|||Mixed Models Analysis|||||0.136|-0.240|0.5866
74068139|NCT02040766|147687737|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0587|TWO_SIDED|95.0|-0.369|0.007|||Mixed Models Analysis|||||0.007|-0.369|0.0587
74068140|NCT02040766|147687738|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.0011|TWO_SIDED|95.0|-0.261|-0.065|||Mixed Models Analysis|||||-0.065|-0.261|0.0011
74068141|NCT02040766|147687738|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.0869|TWO_SIDED|95.0|-0.185|0.013|||Mixed Models Analysis|||||0.013|-0.185|0.0869
74068142|NCT02040766|147687738|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.4388|TWO_SIDED|95.0|-0.138|0.06|||Mixed Models Analysis|||||0.060|-0.138|0.4388
74068143|NCT02040766|147687738|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.1041|TWO_SIDED|95.0|-0.18|0.017|||Mixed Models Analysis|||||0.017|-0.180|0.1041
74068144|NCT02040766|147687739|SUPERIORITY|||||||0.287|||||||Log Rank|||||||0.2870
74068145|NCT02040766|147687739|SUPERIORITY|||||||0.5257|||||||Log Rank|||||||0.5257
74068146|NCT02040766|147687739|SUPERIORITY|||||||0.9982|||||||Log Rank|||||||0.9982
74068147|NCT02040766|147687739|SUPERIORITY|||||||0.7633|||||||Log Rank|||||||0.7633
74068148|NCT01227668|147687785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.097|TWO_SIDED|95.0|0.28|1.12|||Stratified log rank|||||1.12|0.28|0.097
74068149|NCT01227668|147687786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.051|TWO_SIDED|95.0|-8.82|0.02||For secondary endpoints, hierarchical testing aimed to keep the overall experiment-wise type I error rate to \<=0.05. Difference in chg from BL was tested at 0.05 significance only if APR arm significantly differed vs placebo from primary analysis.|ANCOVA|||||0.02|-8.82|0.051
74068150|NCT01227668|147687787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.09|TWO_SIDED|95.0|-1.3|0.1||Treatment diff in chg from BL to endpnt in IS score was tested at 0.05 signif only if ARP arm signif differed vs pb from PA. Thus, if ARP arm signif differed vs pb in IS score, treatment diff in mean CGI-I score at endpnt was tested at 0.05 signfnce.|ANCOVA|||||0.1|-1.3|0.090
74068151|NCT01033864|147687791|SUPERIORITY_OR_OTHER|||||||0.8055|||||||Wilcoxon (Mann-Whitney)|||||||0.8055
74068152|NCT01033864|147687792|SUPERIORITY_OR_OTHER|||||||0.2548|||||||Wilcoxon (Mann-Whitney)|||||||0.2548
74068153|NCT01033864|147687793|SUPERIORITY_OR_OTHER|||||||0.4417|||||||Wilcoxon (Mann-Whitney)|||||||0.4417
74068154|NCT01033864|147687794|SUPERIORITY_OR_OTHER|||||||0.0455|||||||Wilcoxon (Mann-Whitney)|||||||0.0455
74068155|NCT01033864|147687795|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.2300
74068156|NCT01033864|147687796|SUPERIORITY_OR_OTHER|||||||0.0106|||||||Wilcoxon (Mann-Whitney)|||||||0.0106
74068157|NCT01033864|147687797|SUPERIORITY_OR_OTHER|||||||0.3401|||||||Wilcoxon (Mann-Whitney)|||||||0.3401
74068158|NCT01033864|147687798|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|||||||0.0074
74068159|NCT01033864|147687799|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||||||0.0002
74068160|NCT01709383|147687801|SUPERIORITY_OR_OTHER|||||||0.57|||||||Mixed Models Analysis|||||||.57
74068161|NCT01709383|147687803|SUPERIORITY_OR_OTHER|||||||0.64|||||||Mixed Models Analysis|||||||.64
74068162|NCT00905489|147687838|SUPERIORITY_OR_OTHER||Ratio NVP XR: NVP IR (%)|91.2|STANDARD_ERROR_OF_MEAN|1.05||0.008|TWO_SIDED|90.0|83.47|99.64|||Mixed Models Analysis|Adjusted geometric means are estimated from the mixed model for intra-individual comparison.||||99.64|83.47|0.0080
74068163|NCT02668302|147687870|SUPERIORITY|||||||0.4709|||||||t-test, 2 sided|P-values from two-sample T-test with equal variance assumption||||||0.4709
74068164|NCT01149616|147687887|SUPERIORITY|||||||0.007|||||||ANOVA|||||||0.007
74068165|NCT01149616|147687888|SUPERIORITY|||||||0.006|||||||ANOVA|||||||0.006
74068166|NCT01149616|147687889|SUPERIORITY|||||||0.05||||||P value was calculated, and threshold for significance calculated at less than or equal to 0.05|ANOVA|||||||0.05
74068167|NCT01512979|147687892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.13|-0.46||The model includes treatment and continuous baseline HbA1c.|ANCOVA|||||-0.46|-1.13|<0.0001
74068168|NCT01512979|147687893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|5.7||0.0032||95.0|-28.0|-5.7||The model includes treatment, continuous baseline HbA1c and continuous baseline FPG.|ANCOVA|||||-5.7|-28.0|0.0032
74068169|NCT01512979|147687895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83||||0.0031||95.0|1.573|9.328||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||9.328|1.573|0.0031
74068170|NCT01512979|147687896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.0025||95.0|1.458|5.849||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||5.849|1.458|0.0025
74068171|NCT01512979|147687897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.448||||0.0008||95.0|1.453|4.123||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||4.123|1.453|0.0008
74068172|NCT00526890|147687911|OTHER|||||||0.3149|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.||||0.3149
74068173|NCT03529955|147687917|EQUIVALENCE|The student t test (paired) and ANOVA analysis of variance were used to assess the mean change in CDASI, MMT-8, DLQI and to compare the positive cell detection on immunohistochemistry for CCL5, pSTAT1 and pSTAT3 at baseline and 3 months post apremilast. All p values were two-sided, and values \<0.05 were considered statistically significant. Analyses were performed using GraphPad Prism 8 (GraphPad Software Inc.). The last observation carried forward approach was used for missing values.||||||0.01||||||The investigators hypothesized that genes identified as significantly differentially expressed between the two groups will have ≥2-fold change at p\<0.01.|ANOVA|||The student t test (paired) and ANOVA analysis of variance were used to assess the mean change in CDASI, MMT-8, DLQI and to compare the positive cell detection on immunohistochemistry for CCL5, pSTAT1 and pSTAT3 at baseline and 3 months post apremilast. All p values were two-sided, and values \<0.05 were considered statistically significant. Analyses were performed using GraphPad Prism 8 (GraphPad Software Inc.). The last observation carried forward approach was used for missing values.||||0.01
74068174|NCT01016652|147687930|NON_INFERIORITY_OR_EQUIVALENCE|This is a non-inferiority analysis, with \>=5 CLUE points being the non-inferiority margin.|Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-9.86|1.59|||Mixed Models Analysis|||"Ho: There are not significant differences between the two lenses (etafilcon A multifocal (test) vs. etafilcon A sphere (control)for Vision quality.~Ha: The test lens is greater than or equal by 5 CLUE points than the control lense."||1.59|-9.86|
74068175|NCT01016652|147687931|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin will be exceeded if the test lens is greater than or equal to 0.25D over the control lens.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.09|0.1|||Mixed Models Analysis|||"Ho: There is not a difference between the test lens and the control lens for amplitude of accommodation.~Ha: Monocular amplitude of accommodation of the test lens is significantly better than the control lens"||0.10|-0.09|
74068176|NCT02060461|147687936|OTHER|||||||0.003|||||||t-test, 2 sided|||Paired Students t-test of FS200 and IntraLase intraoperative flap thickness measurements obtained by ultrasound pachymetry||||.003
74068177|NCT01133821|147687957|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||time effect for HRSD-17||||<0.0001
74068178|NCT01133821|147687958|SUPERIORITY||||||>|0.05|||||||Regression, Linear|Adjusted for baseline scores||||||>0.05
74068179|NCT01387282|147687959|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis||||< 0.0001
74068180|NCT01387282|147687960|SUPERIORITY_OR_OTHER|||||||0.648|||||||Wilcoxon rank sum test|||Superiority analysis||||0.6480
74068181|NCT01387282|147687961|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Mixed Models Analysis|||Superiority analysis||||0.0016
74068182|NCT01387282|147687962|SUPERIORITY_OR_OTHER|||||||0.8637|||||||Mixed Models Analysis|||Superiority analysis||||0.8637
74068183|NCT01387282|147687963|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis||||< 0.0001
74068184|NCT03273387|147687964|SUPERIORITY|||||||0.008||||||95% Confidence interval 1.97 - 11.3 statistical significant if p\<0.05|t-test, 2 sided|t=2.988 df=18||||||0.008
74068185|NCT03273387|147687965|SUPERIORITY|||||||0.33||||||statistical significant if p \<0.05|two-way ANOVA|DF=3||||||0.33
74068186|NCT03273387|147687966|SUPERIORITY|||||||0.0002||||||95% Confidence interval 15.92 to 42.53 statistical significant if p \<0.05|t-test, 2 sided|t=4.598 df=19||||||0.0002
74068187|NCT03551730|147687977|SUPERIORITY||Least Squares Means (Difference)|-0.23|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
74068188|NCT03551730|147687977|SUPERIORITY||Least Squares Means (Difference)|-0.2|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
74068189|NCT03551730|147687977|SUPERIORITY||Least Squares Means (Difference)|-0.23|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
74068190|NCT03551730|147687978|SUPERIORITY||Least Squares Means (Difference)|53922.58||||0.1529|TWO_SIDED||||||ANCOVA|||||||0.1529
74068191|NCT03551730|147687978|SUPERIORITY||Least Squares Means (Difference)|124993.1|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
74068192|NCT03551730|147687978|SUPERIORITY||Least Squares Means (Difference)|96385.09||||0.0032|TWO_SIDED||||||ANCOVA|||||||0.0032
74068193|NCT03907280|147687985|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T1/R) [%]|0.5|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|0.39|0.63|||Mixed Models Analysis||The standard error of the mean is actually the geometric standard error.|Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||0.63|0.39|
74068194|NCT03907280|147687985|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T2/R) [%]|40.26|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|31.68|51.15|||Mixed Models Analysis||The standard error of the mean is actually the geometric standard error.|Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||51.15|31.68|
74068195|NCT03907280|147687985|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T3/R) [%]|40.24|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|31.86|50.83|||Mixed Models Analysis|The standard error of the mean is actually the geometric standard error.||Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||50.83|31.86|
74068196|NCT02491788|147687986|SUPERIORITY||Mean Difference (Final Values)|2.16|STANDARD_ERROR_OF_MEAN|0.75|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
74068197|NCT01464827|147687990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.406|TWO_SIDED|95.0|0.09|2.61||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Group G|"The primary efficacy endpoint was the comparison of the percentage of treatment-naïve participants with SVR24 after treatment with 3 DAAs (at the 150 mg ABT-450 dose) and ribavirin for 8 weeks (Group A) versus 12 weeks (Group G).~Logistic regression with baseline log10 HCV RNA level, treatment group, Interleukin 28B genotype (CC or non-CC), HCV subgenotype (1a or non-1a), and geographic region (US or non-US) as predictors."||2.61|0.09|0.406
74068198|NCT01464827|147687991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.266|TWO_SIDED|95.0|0.08|2.02||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment for 8 weeks versus 12 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||2.02|0.08|0.266
74068199|NCT01464827|147687991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.525|TWO_SIDED|95.0|0.18|2.4||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups \[H + I + M + N\]|The percentage of participants with SVR24 after treatment for 8 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||2.40|0.18|0.525
74068200|NCT01464827|147687991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.375|TWO_SIDED|95.0|0.55|4.92||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups \[F + G + K + L\] : Groups \[H + I + M + N\]|The percentage of participants with SVR24 after treatment for 12 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||4.92|0.55|0.375
74068201|NCT01464827|147687992|SUPERIORITY_OR_OTHER||Difference|-12.16||||0.068|TWO_SIDED|95.0|-25.2|0.88||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group B - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||0.88|-25.20|0.068
74068202|NCT01464827|147687992|SUPERIORITY_OR_OTHER||Difference|-6.75||||0.065|TWO_SIDED|95.0|-13.93|0.43||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Groups \[C + D + J\] - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||0.43|-13.93|0.065
74068203|NCT01464827|147687993|SUPERIORITY_OR_OTHER||Difference|-7.13||||0.106|TWO_SIDED|95.0|-15.77|1.51||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group E - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 3 DAAs with and without ribavirin was compared using a stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||1.51|-15.77|0.106
74068204|NCT01464827|147687994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.616|TWO_SIDED|95.0|0.37|5.34||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups \[F + G + H + I\] : Groups \[K + L + M + N\]|The percentage of participants with SVR24 after treatment with 3 DAAs and ribavirin in treatment-naïve versus null-responders was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose as predictors.||5.34|0.37|0.616
74068205|NCT00981253|147687999|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-18.7|-1.5|||ANCOVA|||||-1.5|-18.7|
74068206|NCT00981253|147688000|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
74068207|NCT00981253|147688001|SUPERIORITY||Cox Proportional Hazard|0.47|||||TWO_SIDED|95.0|0.24|0.91|||Log Rank|||||0.91|0.24|
74068208|NCT00981253|147688002|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.95|TWO_SIDED|95.0|-0.14|1.17|||ANCOVA|||||1.17|-0.14|.95
74068209|NCT00981253|147688003|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.99|TWO_SIDED|95.0|-0.22|0.46|||ANCOVA|||||0.46|-0.22|0.99
74068210|NCT00981253|147688004|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.99|TWO_SIDED|95.0|-0.78|1.74|||ANCOVA|||||1.74|-0.78|0.99
73883390|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.123|||<|0.0001|TWO_SIDED|95.0|1.483|2.763|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.763|1.483|<.0001
74068211|NCT00981253|147688005|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.99|TWO_SIDED|95.0|-0.22|0.46|||ANCOVA|||||0.46|-0.22|0.99
74068212|NCT00981253|147688005|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.99|TWO_SIDED|95.0|-0.14|0.39|||ANCOVA|||||0.39|-0.14|0.99
74068213|NCT03882047|147688006|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068214|NCT03882047|147688006|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068215|NCT03882047|147688006|OTHER|||||||0.03|||||||ANOVA|||||||0.03
74068216|NCT03882047|147688007|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068217|NCT03882047|147688007|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068218|NCT03882047|147688007|OTHER|||||||0.31|||||||ANOVA|||||||0.31
74068219|NCT03882047|147688008|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068220|NCT03882047|147688008|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068221|NCT03882047|147688008|OTHER|||||||0.01|||||||ANOVA|||||||0.01
74068222|NCT03882047|147688009|OTHER|||||||0.08|||||||ANOVA|||||||0.08
74068223|NCT03882047|147688009|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068224|NCT03882047|147688009|OTHER|||||||0.1|||||||ANOVA|||||||0.10
74068225|NCT03882047|147688010|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068226|NCT03882047|147688010|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068227|NCT03882047|147688010|OTHER|||||||0.01|||||||ANOVA|||||||0.01
74068228|NCT03882047|147688011|OTHER|||||||0.02|||||||ANOVA|||||||0.02
74068229|NCT03882047|147688011|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068230|NCT03882047|147688011|OTHER|||||||0.05|||||||ANOVA|||||||0.05
74068231|NCT03882047|147688012|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068232|NCT03882047|147688012|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068233|NCT03882047|147688012|OTHER|||||||0.06|||||||ANOVA|||||||0.06
74068234|NCT03882047|147688013|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068235|NCT03882047|147688013|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068236|NCT03882047|147688013|OTHER|||||||0.46|||||||ANOVA|||||||0.46
74068237|NCT03882047|147688014|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068238|NCT03882047|147688014|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068239|NCT03882047|147688014|OTHER|||||||0.07|||||||ANOVA|||||||0.07
74068240|NCT03882047|147688015|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068241|NCT03882047|147688015|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068242|NCT03882047|147688015|OTHER|||||||0.53|||||||ANOVA|||||||0.53
74068243|NCT03882047|147688016|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068244|NCT03882047|147688016|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
74068245|NCT03882047|147688016|OTHER|||||||0.12|||||||ANOVA|||||||0.12
74068246|NCT01333033|147688026|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
74068247|NCT01992107|147688048|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H1N1||1.14|0.93|
74068248|NCT01992107|147688048|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.05|||||TWO_SIDED|95.0|0.97|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H3N2||1.14|0.97|
74068249|NCT01992107|147688048|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|0.99|||||TWO_SIDED|95.0|0.89|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1||1.1|0.89|
74068250|NCT01992107|147688048|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.0|||||TWO_SIDED|95.0|0.87|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2||1.14|0.87|
74068251|NCT01992107|147688049|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|2.0|||||TWO_SIDED|95.0|-2.5|6.9|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H1N1||6.9|-2.5|
74068252|NCT01992107|147688049|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|4.0|||||TWO_SIDED|95.0|-1.4|9.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H3N2||9.2|-1.4|
74068253|NCT01992107|147688049|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|0.0|||||TWO_SIDED|95.0|-5.5|4.5|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1||4.5|-5.5|
74068254|NCT01992107|147688049|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|-2.0|||||TWO_SIDED|95.0|-6.5|3.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2||3.2|-6.5|
74068255|NCT01992107|147688055|SUPERIORITY_OR_OTHER||Ratios of GMT (Day 22/Day 50)|0.25|||||TWO_SIDED|95.0|0.22|0.29||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2.The upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c/GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.||0.29|0.22|
74068256|NCT01992107|147688056|SUPERIORITY_OR_OTHER||Difference b/w SC rates(Day 22/Day 50)|-47.0|||||TWO_SIDED|95.0|-51.1|-42.1||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.||-42.1|-51.1|
74068257|NCT01992107|147688057|SUPERIORITY_OR_OTHER||Ratios of GMT (Day 22/Day 50)|0.38|||||TWO_SIDED|95.0|0.35|0.42||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1.The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.||0.42|0.35|
74068258|NCT01992107|147688058|SUPERIORITY_OR_OTHER||Difference b/w SC rates(Day 22/Day 50)|-34.0|||||TWO_SIDED|95.0|-38.8|-29.3||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.||-29.3|-38.8|
74068259|NCT02022007|147688062|SUPERIORITY_OR_OTHER|||||||0.007|||||||McNemar|||Study change from dysglycemia to normal glucose state||||.007
74068260|NCT02022007|147688063|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA|||This was a Subjects (SS)/Groups repeated measures design||||.02
74068261|NCT02022007|147688064|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|n||Pretreatment fasting glucose levels were compared with post-treatment levels||||<0.0001
74068262|NCT02022007|147688065|SUPERIORITY_OR_OTHER|||||||0.038|||||||ANOVA|||||||.038
74068263|NCT02022007|147688066|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|||||||0.003
74068264|NCT02022007|147688067|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANOVA|||||||.025
74068265|NCT02022007|147688068|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||0.006
74068266|NCT02022007|147688069|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
74068267|NCT02022007|147688070|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||.026
74068268|NCT02022007|147688071|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
74068269|NCT02022007|147688072|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
73883391|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.146|||<|0.0001|TWO_SIDED|95.0|1.461|2.83|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.830|1.461|<.0001
74068270|NCT02022007|147688073|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
74068271|NCT02444533|147688158|SUPERIORITY|||||||0.043|||||||t-test, 2 sided|||Comparison between groups for pain on day of surgery. Statistical significance was defined as a p-value less than 0.05.||||0.043
74068272|NCT02444533|147688158|SUPERIORITY|||||||0.445|||||||t-test, 2 sided|||Comparison between groups for pain at 14 days after surgery. Statistical significance was defined as a p-value less than 0.05.||||0.445
74068273|NCT02444533|147688159|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||Comparison between groups for ibuprofen usage. Statistical significance was defined as a p-value less than 0.05.||||0.650
74068274|NCT02444533|147688159|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||Comparison between groups for acetaminophen usage. Statistical significance was defined as a p-value less than 0.05.||||0.970
74068275|NCT02444533|147688159|SUPERIORITY|||||||0.835|||||||t-test, 2 sided|||Comparison between groups for oxycodone usage. Statistical significance was defined as a p-value less than 0.05.||||0.835
74068276|NCT02444533|147688160|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison between groups at 7 days. Statistical significance was defined as a p-value less than 0.05.||||1.0
74068277|NCT05085613|147688184|SUPERIORITY||Mean Difference (Final Values)|0.6279928|STANDARD_ERROR_OF_MEAN|4.150369||0.998|TWO_SIDED|95.0|-9.463627|10.71961||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF=6|Economic recovery condition - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||10.71961|-9.463627|0.998
74068278|NCT05085613|147688184|SUPERIORITY||Mean Difference (Final Values)|4.044194|STANDARD_ERROR_OF_MEAN|4.302202||0.725|TWO_SIDED|95.0|-6.416608|14.505||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||14.505|-6.416608|0.725
74068279|NCT05085613|147688184|SUPERIORITY||Mean Difference (Final Values)|-1.53656|STANDARD_ERROR_OF_MEAN|-1.53656||0.98|TWO_SIDED|95.0|-12.25295|9.179834||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||9.179834|-12.25295|0.980
74068280|NCT05085613|147688185|SUPERIORITY||Mean Difference (Final Values)|7.002255|STANDARD_ERROR_OF_MEAN|8.801527||0.813|TWO_SIDED|95.0|-14.39448|28.39899||Sidak's adjusted p-value for multiple comparisons|ANCOVA|Df = 6|Economic recovery condition - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||28.39899|-14.39448|0.813
74068281|NCT05085613|147688185|SUPERIORITY||Mean Difference (Final Values)|15.12214|STANDARD_ERROR_OF_MEAN|9.07444||0.268|TWO_SIDED|95.0|-6.938055|37.18234||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||37.18234|-6.938055|0.268
74068282|NCT05085613|147688185|SUPERIORITY||Mean Difference (Final Values)|14.4032|STANDARD_ERROR_OF_MEAN|9.305576||0.33|TWO_SIDED|95.0|-8.218891|37.0253||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - Control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||37.0253|-8.218891|0.330
74068283|NCT05085613|147688186|SUPERIORITY||Mean Difference (Final Values)|-1.457003|STANDARD_ERROR_OF_MEAN|6.380984||0.994|TWO_SIDED|95.0|-16.98852|14.07451||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Economic recovery - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||14.07451|-16.98852|0.994
74068284|NCT05085613|147688186|SUPERIORITY||Mean Difference (Final Values)|-1.097586|STANDARD_ERROR_OF_MEAN|6.675066||0.998|TWO_SIDED|95.0|-17.34491|15.14973||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||15.14973|-17.34491|0.998
74068285|NCT05085613|147688186|SUPERIORITY||Mean Difference (Final Values)|8.926191|STANDARD_ERROR_OF_MEAN|6.588643||0.447|TWO_SIDED|95.0|-7.110771|24.96315||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Humor - Control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||24.96315|-7.110771|0.447
74068286|NCT05085613|147688187|SUPERIORITY||Mean Difference (Final Values)|-4.154612|STANDARD_ERROR_OF_MEAN|1.986723||0.113|TWO_SIDED|95.0|-8.985328|0.6761041||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Economic recovery - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||.6761041|-8.985328|0.113
74068287|NCT05085613|147688187|SUPERIORITY||Mean Difference (Final Values)|-2.685896|STANDARD_ERROR_OF_MEAN|2.046067||0.473|TWO_SIDED|95.0|-7.6609|2.289114||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||2.289114|-7.66090|0.473
74068288|NCT05085613|147688187|SUPERIORITY||Mean Difference (Final Values)|-6.469932|STANDARD_ERROR_OF_MEAN|2.102231||0.008|TWO_SIDED|95.0|-11.58151|-1.358358||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||-1.358358|-11.58151|0.008
73888318|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|167.3|||<|0.0001|TWO_SIDED|95.0|115.7|218.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||218.9|115.7|<0.0001
74068289|NCT00952484|147688188|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-value based on Wilcoxon rank sum test comparing the median RGI-C score for the asfotase alfa combined reporting group to the historical control group.|Wilcoxon (Mann-Whitney)|||||||0.0007
74068290|NCT00952484|147688189|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0097
74068291|NCT00952484|147688190|SUPERIORITY_OR_OTHER|||||||0.0789|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0789
73883392|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.158|||<|0.0001|TWO_SIDED|95.0|1.447|2.869|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.869|1.447|<.0001
74068292|NCT00952484|147688191|SUPERIORITY_OR_OTHER|||||||0.7417|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.7417
74068293|NCT00952484|147688192|SUPERIORITY_OR_OTHER|||||||0.757|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a Wilcoxon Signed-Rank test.|Wilcoxon Signed-Rank|||||||0.7570
74068294|NCT00952484|147688193|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||<0.0001
73883393|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.181|||<|0.0001|TWO_SIDED|95.0|1.42|2.941|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.941|1.420|<.0001
74068295|NCT00952484|147688194|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0007
73883394|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.193|||<|0.0001|TWO_SIDED|95.0|1.404|2.983|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.983|1.404|<.0001
73883395|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.216|||<|0.0001|TWO_SIDED|95.0|1.373|3.059|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.059|1.373|<.0001
74068296|NCT01945138|147688262|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
74068297|NCT01945138|147688263|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||t-test, 2 sided|||||||0.115
74068298|NCT01945138|147688264|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||t-test, 2 sided|||||||0.193
74068299|NCT01945138|147688265|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED||||||t-test, 2 sided|||||||0.848
74068300|NCT01945138|147688266|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||t-test, 2 sided|||||||0.074
73883396|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.228|||<|0.0001|TWO_SIDED|95.0|1.355|3.102|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.102|1.355|<.0001
74068301|NCT01945138|147688267|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||t-test, 2 sided|||||||0.38
74068302|NCT01945138|147688268|SUPERIORITY_OR_OTHER|||||||0.461|TWO_SIDED||||||t-test, 2 sided|||||||0.461
74068303|NCT01945138|147688269|SUPERIORITY_OR_OTHER|||||||0.205|TWO_SIDED||||||t-test, 2 sided|||||||0.205
74068304|NCT01945138|147688270|SUPERIORITY_OR_OTHER|||||||0.157|TWO_SIDED||||||t-test, 2 sided|||||||0.157
74068305|NCT01945138|147688271|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||t-test, 2 sided|||||||0.443
74068306|NCT01945138|147688272|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
74068307|NCT01945138|147688273|SUPERIORITY_OR_OTHER|||||||0.401|TWO_SIDED||||||t-test, 2 sided|||||||0.401
74068308|NCT01945138|147688274|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
74068309|NCT01945138|147688275|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||t-test, 2 sided|||||||0.325
74068310|NCT01945138|147688276|SUPERIORITY_OR_OTHER|||||||0.311|TWO_SIDED||||||t-test, 2 sided|||||||0.311
74068311|NCT00617461|147688287|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.29||||0.013|TWO_SIDED|90.0|-0.48|-0.1|||ANCOVA|An ANCOVA (repeated measures mixed model) with body mass index, baseline 24-hr average pain intensity, and grouped center as covariates was used.||||-0.10|-0.48|0.013
74068312|NCT00358826|147688309|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
74068313|NCT00358826|147688309|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
74068314|NCT00358826|147688309|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
74068315|NCT00358826|147688310|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
74068316|NCT00358826|147688310|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
74068317|NCT00358826|147688310|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
74068318|NCT00358826|147688311|SUPERIORITY_OR_OTHER|||||||0.656||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.656
74068319|NCT00358826|147688311|SUPERIORITY_OR_OTHER|||||||0.863||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.863
74068320|NCT00358826|147688311|SUPERIORITY_OR_OTHER|||||||0.996||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.996
73888319|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|148.3|||<|0.0001|TWO_SIDED|95.0|96.8|199.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.7|96.8|<0.0001
74068321|NCT00358826|147688312|SUPERIORITY_OR_OTHER|||||||0.331||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.331
74068322|NCT00358826|147688312|SUPERIORITY_OR_OTHER|||||||0.606||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.606
74068323|NCT00358826|147688312|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANOVA|||||||<0.001
74068324|NCT00358826|147688313|SUPERIORITY_OR_OTHER|||||||0.22||||||Dunnett test compared with Placebo|ANCOVA|||||||0.22
74068325|NCT00358826|147688313|SUPERIORITY_OR_OTHER||||||<|0.005||||||Dunnett test compared with Placebo|ANCOVA|||||||<0.005
74068326|NCT00358826|147688313|SUPERIORITY_OR_OTHER|||||||0.6||||||Dunnett test compared with Placebo|ANCOVA|||||||0.60
74068327|NCT00358826|147688314|SUPERIORITY_OR_OTHER|||||||0.92||||||Dunnett test compared with Placebo|ANCOVA|||||||0.92
74068328|NCT00358826|147688314|SUPERIORITY_OR_OTHER|||||||0.96||||||Dunnett test compared with Placebo|ANCOVA|||||||0.96
74068329|NCT00358826|147688314|SUPERIORITY_OR_OTHER|||||||1||||||Dunnett test compared with Placebo|ANCOVA|||||||1.00
74068330|NCT00358826|147688315|SUPERIORITY_OR_OTHER|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA|||||||0.99
74068331|NCT00358826|147688315|SUPERIORITY_OR_OTHER|||||||0.11||||||Dunnett test compared with Placebo|ANCOVA|||||||0.11
74068332|NCT00358826|147688315|SUPERIORITY_OR_OTHER|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA|||||||0.99
74068333|NCT00320593|147688334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|0.01|0.55|||ANCOVA|||The primary analysis was a comparison of treatment groups using an analysis of covariance (ANCOVA) model in which myopia at 3 years was adjusted for myopia at baseline and prior SVL wear. The sample size was computed to reach a 90% power and type I error rate of 5%, so that a difference in 3-year myopia progression between treatment groups would be detected if the true difference was at least 0.60 D, assuming a standard deviation of 0.85 D in each group and loss of follow up of 10%.||0.55|0.01|
74068334|NCT00320593|147688334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|0.02|0.53|||ANCOVA|||An adjusted analysis for the treatment group difference of change in spherical equivalent from baseline to 3 years was performed by including in an analysis of covariance (ANCOVA) model the following covariates in addition to baseline myopia and prior single vision lens wear, which are known to be related to myopia progression: age, sex, ethnicity, accommodative lag, and magnitude of near esophoria.||0.53|0.02|
74068335|NCT00320593|147688337|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.005|0.28|||ANCOVA|||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 1 year, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 1 year, in which myopia at 1 year was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 1 year values were known) were included.||0.28|-0.005|
74068336|NCT00320593|147688338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|0.02|0.45|||ANCOVA|||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 2 years, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 2 years, in which myopia at 2 years was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 2 year values were known) were included.||0.45|0.02|
74068337|NCT00457665|147688343|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||||||0.94
74068338|NCT01716754|147688345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.576|TWO_SIDED|95.0|0.35|1.78|||Regression, Logistic|||||1.78|0.35|0.576
74068339|NCT01716754|147688345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.556|TWO_SIDED|95.0|0.46|1.52|||Regression, Logistic|||||1.52|0.46|0.556
74068340|NCT01716754|147688347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.483|TWO_SIDED|95.0|0.61|2.86|||Regression, Logistic|||||2.86|0.61|0.483
74068341|NCT01716754|147688347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.261|TWO_SIDED|95.0|0.79|2.44|||Regression, Logistic|||||2.44|0.79|0.261
74068342|NCT01716754|147688349|SUPERIORITY_OR_OTHER|||||||0.604|||||||Repeated measures mixed model|||Morning||||0.604
74068343|NCT01716754|147688349|SUPERIORITY_OR_OTHER|||||||0.26|||||||Repeated measures mixed model|||Morning||||0.260
74068344|NCT01716754|147688349|SUPERIORITY_OR_OTHER|||||||0.937|||||||Repeated measures mixed model|||Evening||||0.937
74068345|NCT01716754|147688349|SUPERIORITY_OR_OTHER|||||||0.88|||||||Repeated measures mixed model|||Evening||||0.880
74068346|NCT01716754|147688349|SUPERIORITY_OR_OTHER|||||||0.762|||||||Repeated measures mixed model|||Overall daily||||0.762
74068347|NCT01716754|147688349|SUPERIORITY_OR_OTHER|||||||0.408|||||||Repeated measures mixed model|||Overall daily||||0.408
74068348|NCT00481247|147688350|SUPERIORITY_OR_OTHER|||||||0.0056||||||A priori threshold for statistical significance=0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Hasford Score.||||||0.0056
74068349|NCT00481247|147688351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.55|1.13||||||||1.13|0.55|
74068350|NCT00481247|147688353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|1.2|1.77||||||Hazard Ratio and Confidence Interval were based on analyses on all randomized subjects||1.77|1.20|
74068351|NCT00481247|147688354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|1.25|1.89||||||Hazard Ratio, and Confidence Interval were based on analyses on all randomized subjects||1.89|1.25|
74068352|NCT01620489|147688369|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.66|||<|0.0001||95.0|-0.9|-0.43||Adjustment for multiple comparisons was not used since there was only one primary endpoint.|Mixed Models Analysis|||The null hypothesis of no treatment difference was tested using a two-sided test based on a mixed model repeated measurement (MMRM) analysis. The model included treatment, country, stratification groups (6 groups from cross-classifying renal function category (2 levels: eGFR\<45 and ≥45 mL/min) and the background insulin treatment category (3 levels: basal, premix or no insulin)) as fixed effects factors and baseline HbA1c as a covariate, all nested within week.||-0.43|-0.90|<0.0001
74068353|NCT01620489|147688370|SUPERIORITY_OR_OTHER||Estimated odds ratio|4.48|||<|0.0001||95.0|2.46|8.18||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c and body weight at baseline as covariates. No weight gain was defined as change from baseline to Week 26 in body weight ≤0 kg.||8.18|2.46|<0.0001
74068354|NCT01620489|147688371|SUPERIORITY_OR_OTHER||Estimated odds ratio|3.94|||<|0.0001||95.0|2.12|7.3||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c at baseline as covariates.||7.30|2.12|<0.0001
74068355|NCT01620489|147688372|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.08|||<|0.0001||95.0|-1.58|-0.58||Not adjusted for multiple comparisons|Mixed Models Analysis|||Mean change from baseline in the 7-point profile (SMPG) after 26 weeks treatment was analysed using an MMRM model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.||-0.58|-1.58|<0.0001
74068356|NCT01620489|147688373|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.51|||=|0.0022||95.0|-0.83|-0.18|||Mixed Models Analysis|Not adjusted for multiple comparisons||Change from baseline in BMI (kg/m˄2) after 26 weeks treatment was analysed separately using an MMRM analysis model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.||-0.18|-0.83|= 0.0022
73888320|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|135.6|||<|0.0001|TWO_SIDED|95.0|84.0|187.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||187.2|84.0|<0.0001
74068357|NCT01620489|147688374|SUPERIORITY_OR_OTHER||Estimated treatment ratio|0.98|||=|0.3575||95.0|0.94|1.02||Not adjusted for multiple comparisons|Mixed Models Analysis|||The ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 weeks treatment was estimated based on log-transformed data for changes from baseline. The responses were analysed using an MMRM model with treatment, country and stratification groups as fixed effects and log-transformed baseline as a covariate, all nested within visit. The resulting estimates were back-transformed to the original scale.||1.02|0.94|= 0.3575
74068358|NCT02649231|147688375|SUPERIORITY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.28|1.75||||||Confirmed alcohol relapse by drug condition at 6 months using the Alcohol Timeline-Followback. Logistic regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and alcohol education).||1.75|0.28|
74068359|NCT02649231|147688376|SUPERIORITY||Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|1.1|19.0||||||Linear regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and psychoeducation). Only participants with a minimum of 159 days of completed drinking self-report data were included in the main ITT analysis as this was the shortest duration of time before any participant completed the 6 month (23-25 week) follow up in the study. Reporting time was capped at 180 days.||19.0|1.1|
74068360|NCT00696709|147688384|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
74068361|NCT00696709|147688385|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
74068362|NCT00696709|147688386|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
74068363|NCT00696709|147688387|OTHER|The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||||<|0.0001|||||||Longitudinal data analysis (LDA)|LDA with log-transformed VZV responses at each visit as response variables and visit as covariate.||||||<0.0001
74068364|NCT00696709|147688388|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|5.7|||||Miettinen \& Nurminen|||5.7|-10.8|
74068365|NCT00696709|147688388|OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-9.2|8.8|||||Miettinen \& Nurminen|||8.8|-9.2|
74068366|NCT00696709|147688389|OTHER||Difference in Percentage|35.9|||<|0.001|TWO_SIDED|95.0|15.2|52.6|||Miettinen & Nurminen|||||52.6|15.2|<0.001
74068367|NCT00696709|147688389|OTHER||Difference in Percentage|40.4|||<|0.001|TWO_SIDED|95.0|19.6|57.0|||Miettinen & Nurminen|||||57.0|19.6|<0.001
74068368|NCT00696709|147688390|OTHER||Difference in Percentage|-4.7|||||TWO_SIDED|95.0|-25.3|16.1|||||Miettinen \& Nurminen|||16.1|-25.3|
74068369|NCT00696709|147688390|OTHER||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-16.9|24.9|||||Miettinen \& Nurminen|||24.9|-16.9|
74068370|NCT00696709|147688391|OTHER||Difference in Percentage|1.6||||0.48|TWO_SIDED|95.0|-9.3|8.4|||Miettinen & Nurminen|||||8.4|-9.3|0.480
74068371|NCT00696709|147688391|OTHER||Difference in Percentage|1.6||||0.469|TWO_SIDED|95.0|-9.2|8.8|||Miettinen & Nurminen|||||8.8|-9.2|0.469
74068372|NCT00696709|147688392|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|5.7|||||Miettinen \& Nurminen|||5.7|-10.8|
74068373|NCT00696709|147688392|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|6.0|||||Miettinen \& Nurminen|||6.0|-10.8|
74068374|NCT00321711|147688393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||||95.0|0.153|6.95||||||||6.950|0.153|
74068375|NCT00321711|147688393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.333||||||95.0|0.028|3.926||||||||3.926|0.028|
74068376|NCT00321711|147688393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.118||||||95.0|0.007|1.882|||||Adjusted by the stratification factor|||1.882|0.007|
74068377|NCT00321711|147688394|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.063|15.988|||||Romiplostim/placebo|||15.988|0.063|
74068378|NCT00321711|147688395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.827||||||95.0|0.347|9.618|||||Romiplostim/placebo|||9.618|0.347|
74068379|NCT00321711|147688395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.445||||||95.0|0.037|5.325|||||Romiplostim/placebo|||5.325|0.037|
74068380|NCT00321711|147688395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.444||||||95.0|0.032|6.08|||||Romiplostim/placebo|||6.080|0.032|
74068381|NCT00321711|147688396|SUPERIORITY_OR_OTHER||Difference in incidence rate|-33.5||||||95.0|-69.0|2.0|||||Romiplostim - placebo|||2.0|-69.0|
74068382|NCT00321711|147688396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.315||||||95.0|0.029|3.412||||||||3.412|0.029|
74068383|NCT00321711|147688396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.211||||||95.0|0.021|2.082||||||||2.082|0.021|
74068384|NCT01484028|147688398|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.05 LogMAR was used.|Least-square mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.0034|||TWO_SIDED|95.0|0.004|0.017|||Mixed Models Analysis|||The alternative hypothesis is the monocular distance Snellen VA (LogMAR scale) of etafilcon A with embedded print and PVP for dark/light eyes is non-inferior to that of etafilcon A control lenses.||0.017|0.004|
74068385|NCT01360450|147688405|OTHER||Mean Difference (Final Values)|0.05|||>|0.05|TWO_SIDED|||||yes the P value was adjusted for multiple comparisons.|ANOVA|2 sided ANOVA|Mean difference between the two treatment arms|||||>0.05
74068386|NCT04014959|147688425|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|t(35)= -4.47||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||<0.001
74068387|NCT04014959|147688425|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|t(35)= -3.00||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||0.005
74068388|NCT04014959|147688425|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|t(35)= -2.96||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||0.005
74068389|NCT04014959|147688425|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|t(35)= -5.05||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||<0.001
74068390|NCT04014959|147688427|OTHER|Statistics are an unadjusted linear regression of change in DASS-21 depression score on the pre-intervention TMS/fMRI evoked brain response.||||||0.007|||||||Regression, Linear|β = -33.60||Analysis to investigate the correlation between changes in DASS-21 Scores (Secondary Outcome) and Evoked Functional Brain Activity (Other Pre-specified Outcome) pre and post the 3-Day TMS Intervention Regimen.||||0.007
74068391|NCT02661126|147688446|OTHER|Geometric least-squares mean ratio (GMR) of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.4|2.92||||||||2.92|1.40|
74068392|NCT02661126|147688447|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.0|||||TWO_SIDED|90.0|1.39|2.89||||||||2.89|1.39|
74068393|NCT02661126|147688448|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.39|2.92||||||||2.92|1.39|
74068394|NCT02661126|147688449|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.92|||||TWO_SIDED|90.0|1.35|2.74||||||||2.74|1.35|
74068395|NCT02661126|147688455|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.94|||||TWO_SIDED|90.0|1.39|2.72||||||||2.72|1.39|
74068396|NCT02661126|147688456|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.5|2.74||||||||2.74|1.50|
73888321|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|113.6|||<|0.0001|TWO_SIDED|95.0|62.1|165.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||165.0|62.1|<0.0001
74068397|NCT02661126|147688457|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.72|||||TWO_SIDED|90.0|1.15|2.56||||||||2.56|1.15|
74068398|NCT02661126|147688458|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.85|||||TWO_SIDED|90.0|1.2|2.87||||||||2.87|1.20|
74068399|NCT02661126|147688459|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|2.03|||||TWO_SIDED|90.0|1.38|2.97||||||||2.97|1.38|
74068400|NCT02661126|147688463|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.91|||||TWO_SIDED|90.0|1.44|2.53||||||||2.53|1.44|
74068401|NCT02661126|147688464|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.97|||||TWO_SIDED|90.0|1.48|2.63||||||||2.63|1.48|
74068402|NCT02661126|147688465|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.96|||||TWO_SIDED|90.0|1.54|2.48||||||||2.48|1.54|
74068403|NCT02661126|147688466|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.7|||||TWO_SIDED|90.0|1.29|2.24||||||||2.24|1.29|
74068404|NCT02661126|147688467|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.94|||||TWO_SIDED|90.0|1.47|2.57||||||||2.57|1.47|
74068405|NCT02661126|147688470|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.33|||||TWO_SIDED|90.0|0.65|2.75||||||||2.75|0.65|
74068406|NCT02661126|147688471|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.59|||||TWO_SIDED|90.0|0.79|3.19||||||||3.19|0.79|
74068407|NCT02661126|147688472|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.15|||||TWO_SIDED|90.0|0.51|2.57||||||||2.57|0.51|
74068408|NCT02661126|147688473|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.23|||||TWO_SIDED|90.0|0.5|3.05||||||||3.05|0.50|
74068409|NCT02661126|147688474|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.28|||||TWO_SIDED|90.0|0.56|2.91||||||||2.91|0.56|
74068410|NCT02661126|147688479|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.56|||||TWO_SIDED|90.0|1.19|2.05||||||||2.05|1.19|
74068411|NCT02661126|147688480|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.57|||||TWO_SIDED|90.0|1.2|2.05||||||||2.05|1.20|
74068412|NCT02661126|147688481|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.49|||||TWO_SIDED|90.0|1.13|1.98||||||||1.98|1.13|
74068413|NCT02661126|147688482|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.44|||||TWO_SIDED|90.0|1.05|1.98||||||||1.98|1.05|
74068414|NCT02661126|147688483|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.54|||||TWO_SIDED|90.0|1.15|2.07||||||||2.07|1.15|
74068415|NCT02917447|147688491|SUPERIORITY|||||||0.15||||||Omnibus test for difference in change from baseline in PCL by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||0.15
74068416|NCT02917447|147688492|SUPERIORITY|||||||0.049||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||.049
74068417|NCT02917447|147688493|SUPERIORITY|||||||0.92||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||0.92
74068418|NCT01144663|147688495|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|0.01|||||TWO_SIDED|95.0|-1.17|1.2||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the Menjugate Group, two-sided standardized asymptotic 95% CI (confidence interval) for the groups difference \[Nimenrix 3 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||1.2|-1.17|
74068419|NCT01144663|147688495|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percenttage|-0.43|||||TWO_SIDED|95.0|-1.57|0.4||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 3 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||0.4|-1.57|
74068420|NCT01144663|147688495|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-0.88|||||TWO_SIDED|95.0|-2.45|0.43||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to Menjugate Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||0.43|-2.45|
74068421|NCT01144663|147688495|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-1.32|||||TWO_SIDED|95.0|-2.84|-0.48||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||-0.48|-2.84|
74068422|NCT01828255|147688589|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
74068423|NCT02180061|147688604|SUPERIORITY|||||||0.0216||||||One-sided p-value. The ORR was deemed clinically meaningful if the lower bound of the 95% confidence interval exceeded 10% (p\<0.0250).|Exact Binomial Distribution|||||||0.0216
74068424|NCT01469364|147688607|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.2030
74068425|NCT01469364|147688608|SUPERIORITY_OR_OTHER|||||||0.2527|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.2527
74068426|NCT01469364|147688613|SUPERIORITY_OR_OTHER||Mean Absolute Difference|-1.52||||0.34|TWO_SIDED||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 PCS||||0.34
74068427|NCT01469364|147688613|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.78||||0.18|TWO_SIDED||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 MCS||||0.18
74068428|NCT01469364|147688614|SUPERIORITY_OR_OTHER||Median Absolute Difference|1.62||||0.09|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 PCS||||0.09
74068429|NCT01469364|147688614|SUPERIORITY_OR_OTHER||Median Absolute Difference|-1.24||||0.31|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 MCS||||0.31
74068430|NCT01469364|147688615|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.82||||0.56|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ measure||||0.56
74068431|NCT01469364|147688616|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.15||||0.68|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ Measure||||0.68
74068432|NCT01469364|147688617|SUPERIORITY_OR_OTHER|||||||0.7454|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.7454
74068433|NCT01469364|147688618|SUPERIORITY_OR_OTHER|||||||0.9638|TWO_SIDED||||||t-test, 2 sided|Paired t-test was completed.||||||0.9638
74068434|NCT00789802|147688624|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.03
74068435|NCT00789802|147688624|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.02
74068436|NCT02040428|147688656|SUPERIORITY_OR_OTHER|||||||0.0001|ONE_SIDED||||||Adaptive group sequential design|Whitehead method for triangular test||Superiority||||0.0001
74068437|NCT02040428|147688657|SUPERIORITY_OR_OTHER|||||||0.0046|TWO_SIDED||||||Chi-squared|||||||0.0046
74068438|NCT00992264|147688680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.51|1.51|||||OR for smoking abstinence at 12 months in intent to treat sample. Participants receiving content written in a Prescriptive tone were compared against persons receiving content in a Motivational tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).||1.51|0.51|
74068439|NCT00992264|147688680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.66|1.91|||||OR for smoking abstinence at 12 months when persons who randomly received a Testimonial were compared against persons receiving No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).||1.91|0.66|
74068440|NCT00992264|147688680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.7|2.02|||||OR for smoking abstinence at 12 months when persons assigned to Dictated navigation were compared to those not assigned to Dictated navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).||2.02|0.70|
74068441|NCT00992264|147688680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.43|1.3|||||OR for smoking abstinence at 12 months when persons assigned to receive Proactive Email reminders were compared against persons who received No Emails (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).||1.30|0.43|
74068442|NCT00992264|147688681|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.94|||||TWO_SIDED|95.0|0.62|1.43|||||OR for use of adjunct treatment at 12 months when persons assigned to Prescriptive Tone were compared to persons assigned to receive content in a Motivational Tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).||1.43|0.62|
74068443|NCT00992264|147688681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.46|1.07|||||OR for use of adjunct treatment at 12 months when persons assigned to receive a Testimonial were compared to persons assigned to receive No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).||1.07|0.46|
74068444|NCT00992264|147688681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.51|1.18|||||OR for use of adjunct treatment at 12 months when persons assigned to Dictated Navigation were compared to persons not assigned to Dictated Navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).||1.18|0.51|
74068445|NCT00992264|147688681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||OR for use of adjunct treatment at 12 months when persons assigned to Proactive Email reminders were compared to persons not assigned to receive Proactive Email reminders (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).||1.03|0.44|
74068446|NCT01399723|147688695|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority between amoxicillin and benzyl penicillin was defined a priori as a risk difference of treatment failure and associated upper bound of the 95% confidence interval (CI) of \<7%. A sample size of 576 would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-5.0|4.2|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||4.2|-5.0|
74068447|NCT01399723|147688696|NON_INFERIORITY_OR_EQUIVALENCE|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-5.0|5.8|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||5.8|-5.0|
73883397|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.251|||<|0.0001|TWO_SIDED|95.0|1.321|3.18|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.180|1.321|<.0001
74068448|NCT01399723|147688699|NON_INFERIORITY_OR_EQUIVALENCE|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-3.3|||||TWO_SIDED|95.0|-10.0|3.0|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||3.0|-10.0|
74068449|NCT03051256|147688703|SUPERIORITY||||||<|0.0122|||||||Mixed Models Analysis|||||||<0.0122
74068450|NCT03051256|147688703|SUPERIORITY||||||<|0.0308|||||||Mixed Models Analysis|||||||<0.0308
74068451|NCT03051256|147688704|SUPERIORITY||||||<|0.0103|||||||Mixed Models Analysis|||||||<0.0103
74068452|NCT03051256|147688704|SUPERIORITY||||||<|0.0039|||||||Mixed Models Analysis|||||||<0.0039
74068453|NCT03051256|147688705|SUPERIORITY|||||||0.1237|||||||Mixed Models Analysis|||||||0.1237
74068454|NCT03051256|147688705|SUPERIORITY|||||||0.1017|||||||Mixed Models Analysis|||||||0.1017
74068455|NCT03051256|147688706|SUPERIORITY||||||<|0.0066|||||||Mixed Models Analysis|||||||<0.0066
74068456|NCT03051256|147688706|SUPERIORITY||||||<|0.0014|||||||Mixed Models Analysis|||||||<0.0014
74068457|NCT03051256|147688707|SUPERIORITY||||||<|0.0245|||||||Mixed Models Analysis|||||||<0.0245
74068458|NCT03051256|147688707|SUPERIORITY||||||<|0.0253|||||||Mixed Models Analysis|||||||<0.0253
73883398|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.263|||<|0.0001|TWO_SIDED|95.0|1.302|3.225|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.225|1.302|<.0001
74068459|NCT03051256|147688708|SUPERIORITY||||||<|0.0454|||||||Mixed Models Analysis|||||||<0.0454
74068460|NCT03051256|147688708|SUPERIORITY||||||<|0.0043|||||||Mixed Models Analysis|||||||<0.0043
74068461|NCT03051256|147688709|SUPERIORITY|||||||0.0177|||||||Mixed Models Analysis|||||||0.0177
74068462|NCT03051256|147688709|SUPERIORITY|||||||0.0072|||||||Mixed Models Analysis|||||||0.0072
74068463|NCT03051256|147688710|SUPERIORITY|||||||0.0895|||||||Mixed Models Analysis|||||||0.0895
74068464|NCT03051256|147688710|SUPERIORITY|||||||0.0109|||||||Mixed Models Analysis|||||||0.0109
74068465|NCT00268346|147688716|SUPERIORITY_OR_OTHER||percentage response|6.9|||<|0.05|TWO_SIDED|95.0|||||binomial test for a single proportion|||In patients with prior chemotherapy, \>25% response indicates efficacy and \<10% indicates lack of efficacy. In patients with no prior chemotherapy, \>45% response indicates efficacy and \<25% indicates lack of efficacy. Using a 5% significance level, the study was designed to have 80% power to test each hypothesis.||||<0.05
74068466|NCT00294723|147688717|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.62|||<|0.0001||95.0|-0.83|-0.42||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.42|-0.83|<0.0001
74068467|NCT00294723|147688717|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.0014||95.0|-0.53|-0.13||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.13|-0.53|0.0014
74068468|NCT00294723|147688717|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0046||95.0|-0.5|-0.09||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.09|-0.50|0.0046
74068469|NCT00294723|147688718|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.58|||<|0.0001||95.0|-4.28|-2.87||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.87|-4.28|<.0001
74068470|NCT00294723|147688718|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.17|||<|0.0001||95.0|-3.87|-2.47||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.47|-3.87|<.0001
74068471|NCT00294723|147688718|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.41||||0.2584||95.0|-1.11|0.3||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.30|-1.11|0.2584
74068472|NCT00294723|147688719|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.65|||<|0.0001||95.0|-4.44|-2.86||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.86|-4.44|<.0001
74068473|NCT00294723|147688719|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.84|||<|0.0001||95.0|-3.63|-2.06||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.06|-3.63|<.0001
74068474|NCT00294723|147688719|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.8||||0.0462||95.0|-1.59|-0.01||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.01|-1.59|0.0462
74068475|NCT00294723|147688720|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6|||<|0.0001||95.0|-0.83|-0.38||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.38|-0.83|<.0001
74068476|NCT00294723|147688720|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% CI for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.31||||0.0076||95.0|-0.54|-0.08||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.08|-0.54|0.0076
74068477|NCT00294723|147688720|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0129||95.0|-0.52|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.52|0.0129
74068478|NCT00294723|147688721|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.48|||<|0.0001||95.0|-4.28|-2.68||2-sided significance level was 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.68|-4.28|<0.0001
74068479|NCT00294723|147688721|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.72|||<|0.0001||95.0|-3.52|-1.93||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-1.93|-3.52|<0.0001
73883399|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.286|||<|0.0001|TWO_SIDED|95.0|1.266|3.305|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.305|1.266|<.0001
74068480|NCT00294723|147688721|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.75||||0.0642||95.0|-1.55|0.05||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariance.||0.05|-1.55|0.0642
74068481|NCT00294723|147688722|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-20.28|||<|0.0001||95.0|-29.09|-11.46||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-11.46|-29.09|<.0001
74068482|NCT00294723|147688722|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-9.92||||0.027||95.0|-18.7|-1.12||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.12|-18.70|0.0270
74068483|NCT00294723|147688722|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-10.36||||0.0223||95.0|-19.24|-1.48||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.48|-19.24|0.0223
74068484|NCT00294723|147688723|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-17.79||||0.0003||95.0|-27.48|-8.09||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-8.09|-27.48|0.0003
74068485|NCT00294723|147688723|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-11.33||||0.0217||95.0|-20.99|-1.66||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.66|-20.99|0.0217
74068486|NCT00294723|147688723|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg|Estimated treatment difference, LS Mean|-6.46||||0.1942||95.0|-16.23|3.3||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||3.30|-16.23|0.1942
74068487|NCT00294723|147688724|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-16.63||||0.0007||95.0|-26.19|-7.06||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-7.06|-26.19|0.0007
74068488|NCT00294723|147688724|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.02||||0.0395||95.0|-19.56|-0.49||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-0.49|-19.56|0.0395
74068489|NCT00294723|147688724|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1789||95.0|-16.24|3.03||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||3.03|-16.24|0.1789
73888322|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|278.3|||<|0.0001|TWO_SIDED|95.0|213.2|343.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||343.3|213.2|<0.0001
74068490|NCT00294723|147688725|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.9||||0.0038||95.0|-21.6|-4.2||2-sided significance level 5%|ANCOVA|||Change in mean postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-4.2|-21.6|0.0038
74068491|NCT00294723|147688725|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-6.3||||0.1616||95.0|-15.0|2.5||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||2.5|-15.0|0.1616
74068492|NCT00294723|147688725|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1319||95.0|-15.3|2.0||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||2.0|-15.3|0.1319
74068493|NCT00294723|147688726|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.3||||0.0105||95.0|-21.71|-2.89||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-2.89|-21.71|0.0105
74068494|NCT00294723|147688726|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.49||||0.606||95.0|-11.95|6.98||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||6.98|-11.95|0.6060
74068495|NCT00294723|147688726|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.81||||0.0392||95.0|-19.14|-0.49||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-0.49|-19.14|0.0392
74068496|NCT00294723|147688727|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.98||||0.0227||95.0|-20.42|-1.54||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-1.54|-20.42|0.0227
74068497|NCT00294723|147688727|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-1.83||||0.7047||95.0|-11.33|7.66||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||7.66|-11.33|0.7047
74068498|NCT00294723|147688727|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.15||||0.0553||95.0|-18.51|0.21||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||0.21|-18.51|0.0553
73888323|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|71.3||||0.0322|TWO_SIDED|95.0|6.1|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||136.5|6.1|0.0322
73888324|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|195.4|||<|0.0001|TWO_SIDED|95.0|130.2|260.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||260.5|130.2|<0.0001
74068499|NCT00294723|147688728|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided 95% confidence interval (CI) for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%.|Estimated treatment difference, LS Mean|-0.55|||<|0.0001||95.0|-0.77|-0.34||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.34|-0.77|<0.0001
74068500|NCT00294723|147688728|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided 95% confidence interval (CI) for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.28||||0.0122||95.0|-0.49|-0.06||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.49|0.0122
74068501|NCT00294723|147688728|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.28||||0.0123||95.0|-0.49|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.49|0.0123
74068502|NCT00294723|147688729|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-4.0||||0.1396||95.0|-9.4|1.3||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.3|-9.4|0.1396
74068503|NCT00294723|147688729|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.9||||0.2968||95.0|-8.3|2.5||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||2.5|-8.3|0.2968
74068504|NCT00294723|147688729|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-1.2||||0.6639||95.0|-6.5|4.1||2-sided significance level 5%|ANCOVA|||Change in postprandial (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||4.1|-6.5|0.6639
74068505|NCT00294723|147688730|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.81||||0.172||95.0|-9.28|1.66||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.66|-9.28|0.1720
74068506|NCT00294723|147688730|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.906||95.0|-5.82|5.16||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||5.16|-5.82|0.9060
74068507|NCT00294723|147688730|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2089||95.0|-8.91|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.95|-8.91|0.2089
74068508|NCT00294723|147688731|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.04||||0.2749||95.0|-8.51|2.42||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||2.42|-8.51|0.2749
74068509|NCT00294723|147688731|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|0.43||||0.8765||95.0|-5.05|5.92||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||5.92|-5.05|0.8765
74068510|NCT00294723|147688731|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2088||95.0|-8.9|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.95|-8.90|0.2088
74068511|NCT00752791|147688734|SUPERIORITY_OR_OTHER||Mean change from Baseline|0.1|||||TWO_SIDED|95.0|-0.24|0.44|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||0.44|-0.24|
74068512|NCT02784106|147688776|SUPERIORITY||Difference in Proportion of Responders|0.1|||||TWO_SIDED|80.0|-0.07|0.25||||||||0.25|-0.07|
73883400|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.298|||<|0.0001|TWO_SIDED|95.0|1.246|3.351|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.351|1.246|<.0001
74068513|NCT02784106|147688777|SUPERIORITY||Difference in Mean Changes|-1.93|||||TWO_SIDED|80.0|-5.54|1.69||||||||1.69|-5.54|
73888325|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|154.3|||<|0.0001|TWO_SIDED|95.0|89.2|219.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||219.3|89.2|<0.0001
74068514|NCT02784106|147688778|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.13|0.06||||||Day 28||0.06|-0.13|
74068515|NCT02784106|147688778|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.18|0.09||||||Day 56||0.09|-0.18|
74068516|NCT02784106|147688778|SUPERIORITY||Difference in Proportion of Responders|-0.01|||||TWO_SIDED|80.0|-0.15|0.12||||||Day 84||0.12|-0.15|
74068517|NCT02784106|147688779|SUPERIORITY||Difference in Proportion of Responders|0.06|||||TWO_SIDED|80.0|0.01|0.14||||||Day 28||0.14|0.01|
73883401|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.321|||<|0.0001|TWO_SIDED|95.0|1.209|3.433|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.433|1.209|<.0001
74068518|NCT02784106|147688779|SUPERIORITY||Difference in Proportion of Responders|0.03|||||TWO_SIDED|80.0|-0.05|0.11||||||Day 56||0.11|-0.05|
74068519|NCT02784106|147688779|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.15|0.07||||||Day 84||0.07|-0.15|
74068520|NCT02784106|147688780|SUPERIORITY||Difference in Mean Changes|-1.4|||||TWO_SIDED|80.0|-5.37|2.58||||||||2.58|-5.37|
74068521|NCT02784106|147688781|SUPERIORITY||Difference in Mean Changes|-0.08|||||TWO_SIDED|80.0|-0.33|0.16||||||Day 28||0.16|-0.33|
74068522|NCT02784106|147688781|SUPERIORITY||Difference in Mean Changes|0.07|||||TWO_SIDED|80.0|-0.29|0.43||||||Day 84||0.43|-0.29|
74068523|NCT02784106|147688782|SUPERIORITY||Difference in Proportion of Participants|0.08|||||TWO_SIDED|80.0|-0.04|0.21||||||||0.21|-0.04|
74068524|NCT02784106|147688783|SUPERIORITY||Difference in Proportion of Participants|-0.04|||||TWO_SIDED|80.0|-0.13|0.06||||||||0.06|-0.13|
73883402|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.333|||<|0.0001|TWO_SIDED|95.0|1.188|3.479|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.479|1.188|<.0001
74068525|NCT01602614|147688843|OTHER|Spearman Rank Correlation||||||0.3117|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.3117
74068526|NCT01602614|147688844|OTHER|Spearman Rank Correlation||||||0.6175||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.6175
74068527|NCT01602614|147688845|OTHER|Spearman Rank Correlation||||||0.7129||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.7129
74068528|NCT01602614|147688846|OTHER|Spearman Rank Correlation||||||0.9828|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.9828
74068529|NCT01602614|147688847|OTHER|Spearman Rank Correlation||||||0.9656|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.9656
74068530|NCT01602614|147688848|OTHER|Spearman Rank Correlation||||||0.5113|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.5113
74068531|NCT01602614|147688849|OTHER|Spearman Rank Correlation||||||0.217||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.2170
74068532|NCT01602614|147688850|OTHER|Spearman Rank Correlation||||||0.4299||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.4299
74068533|NCT01602614|147688851|OTHER|Spearman Rank Correlation||||||0.8629||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.8629
74068534|NCT01602614|147688852|OTHER|Spearman Rank Correlation||||||0.5717||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.5717
74068535|NCT01851590|147688879|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Proportions and 95% confidence intervals (CIs) were calculated for negative KOH staining, negative cultures, and a combination of these at 4- and 10-month time points. Cochran-Mantel-Haenszel and χ2-tests were used to analyse efficacy criteria.|Cochran-Mantel-Haenszel|||The sample size was estimated according to complete mycological cure at 10 months. Estimation was based on the design of a binary-outcome head-to-head superiority trial. Orally administered terbinafine treatment was considered the active control. Approximately 25 patients / arm were required to have 80% power (β=0.2) at a two-sided α=0.05 significance level to detect a decrease in primary outcome from 50% in the terbinafine arm to 15% in the amorolfine or resin lacquer treatment arms.||||<0.05
74068536|NCT01851590|147688880|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
74068537|NCT01851590|147688881|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
74068538|NCT01851590|147688882|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
74068539|NCT01851590|147688883|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Qualitative data are expressed as frequencies and percentages, and differences between parallel groups were compared with the χ2-test or Fisher's exact test, as appropriate.|Chi-squared|||||||<0.05
74068540|NCT01714505|147688884|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 1 sided|Paired t-tests: compare LBGI, carbohydrates for hypoglycemia treatment, % of time in range and average BG on CLC vs OL.||||||0.003
74068541|NCT01714505|147688885|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 1 sided|||||||>0.1
73883403|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.356||||0.0001|TWO_SIDED|95.0|1.15|3.562|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.562|1.150|0.0001
74068542|NCT01714505|147688886|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
74068543|NCT03740100|147688925|OTHER||Percent with objective response|17.0|||||TWO_SIDED|95.0|1.0|58.0||||||The primary endpoint was to determine the objective response rate of patients with R/M HNSCC harboring NOTCH1 LOF mutations to oral bimiralisib using RECIST v1.1. We used a Simon's optimal two-stage design. In order to have 80% power to detect a response rate of 30%, (one-sided α=0.05 and β=0.20), we planned to enroll up to 10 patients in the first stage. If ≥ 2 patients had an objective response, then the study would enroll an additional 19 patients in the second stage.||58|1|
74068544|NCT00634283|147688931|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
74068545|NCT00634283|147688931|SUPERIORITY|||||||0.32||||||The a priori threshold was set at 0.05, 2-tailed, without adjustment for multiple comparisons.|t-test, 2 sided|||Change in PFC over the one-week placebo lead-in period was compared between antidepressant-experienced and antidepressant-naive groups using a between groups t-test.|"Group differences in PFC changes over time during administration of venlafaxine were assessed using mixed-model analysis.~we compared brain functional changes over the course of venlafaxine treatment between antidepressant-experienced and antidepressant-naïve subjects using linear mixed model analysis (random intercept model) conducted using full maximum likelihood estimation (MLE). Changes in PFC were calculated from the end of placebo lead-in to 48 hours, and 1, 2, and 4 weeks, yielding a within-group factor of time with four levels. We employed a first-order autoregressive covariance structure to reflect our assumption that PFC measurements closer together in time would be more highly correlated."|||0.32
74068546|NCT04192799|147688938|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.65|0.85||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||0.85|0.65|<0.001
74068547|NCT04192799|147688939|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|1.12|||<|0.001|TWO_SIDED|95.0|1.06|1.19||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||1.19|1.06|<0.001
74068548|NCT04192799|147688940|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|0.93||||0.37|TWO_SIDED|95.0|0.8|1.09||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||1.09|0.80|0.37
74068549|NCT04192799|147688941|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Odds Ratio (OR)|1.31||||0.81|TWO_SIDED|95.0|0.14|12.27||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Regression, Logistic|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||12.27|0.14|0.81
74068550|NCT04192799|147688942|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Slope|0.05||||0.12|TWO_SIDED|95.0|-0.01|0.11|||Regression, Linear|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||0.11|-0.01|0.12
74068551|NCT00461500|147689006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.23|STANDARD_ERROR_OF_MEAN|17.6||0.683||95.0|-27.96|42.43|||ANCOVA||mean difference = drug SFC 100 minus FP 100|||42.43|-27.96|0.683
74068552|NCT01151813|147689019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||t-test, 2 sided|||||||.02
74068553|NCT01151813|147689020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||t-test, 2 sided|||||||0.03
74068554|NCT01151813|147689021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||t-test, 2 sided|||||||0.03
74068555|NCT01151813|147689022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||t-test, 2 sided|||||||0.04
74068556|NCT01513551|147689027|OTHER||Risk Difference (RD)|6.8|||||TWO_SIDED|95.0|-1.4|15.0|||Miettinen & Nurminen|||||15.0|-1.4|
74068557|NCT01513551|147689027|OTHER||Risk Difference (RD)|9.5|||||TWO_SIDED|95.0|1.1|17.7|||Miettinen & Nurminen|||||17.7|1.1|
74068558|NCT01806597|147689034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.3||||0.0002|TWO_SIDED|95.0|2.4|154.6|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).||154.6|2.4|0.0002
74068559|NCT01806597|147689034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|29.4|||<|0.0001|TWO_SIDED|95.0|4.1|211.9|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).||211.9|4.1|<0.0001
74068560|NCT03081767|147689043|OTHER||||||<|1e-07||||||Actual P-Value = 3.89597E-42. A P-value of \<0.05 was considered significant.|t-test, 2 sided|||||||<0.0000001
74068561|NCT02247479|147689047|SUPERIORITY||Difference in Adjusted Means|-0.019||||0.8381|TWO_SIDED|95.0|-0.206|0.167|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.167|-0.206|0.8381
73883404|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.369||||0.0002|TWO_SIDED|95.0|1.128|3.609|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.609|1.128|0.0002
74068562|NCT02247479|147689047|SUPERIORITY||Difference in Adjusted Means|0.051||||0.5901|TWO_SIDED|95.0|-0.134|0.236|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.236|-0.134|0.5901
74068563|NCT02247479|147689048|SUPERIORITY||Difference in Adjusted Means|-0.2||||0.935|TWO_SIDED|95.0|-5.2|4.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||4.8|-5.2|0.9350
74068564|NCT02247479|147689048|SUPERIORITY||Difference in Adjusted Means|0.1||||0.9789|TWO_SIDED|95.0|-5.0|5.2|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||5.2|-5.0|0.9789
74068565|NCT02247479|147689049|SUPERIORITY||Difference in Adjusted Means|0.28||||0.5538|TWO_SIDED|95.0|-0.66|1.22|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||1.22|-0.66|0.5538
74068566|NCT02247479|147689049|SUPERIORITY||Difference in Adjusted Means|-0.63||||0.2032|TWO_SIDED|95.0|-1.6|0.35|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.35|-1.60|0.2032
74068567|NCT02247479|147689050|SUPERIORITY||Difference in Adjusted Means|1.0||||0.2547|TWO_SIDED|95.0|-0.7|2.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.8|-0.7|0.2547
74068568|NCT02247479|147689050|SUPERIORITY||Difference in Adjusted Means|-0.2||||0.8423|TWO_SIDED|95.0|-1.9|1.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||1.6|-1.9|0.8423
74068569|NCT02247479|147689051|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3248|TWO_SIDED|95.0|0.8|2.2|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.||2.2|0.8|0.3248
74068570|NCT02247479|147689051|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7209|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.||1.8|0.7|0.7209
74068571|NCT02247479|147689052|SUPERIORITY||Difference in Adjusted Means|0.6||||0.5695|TWO_SIDED|95.0|-1.4|2.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||2.6|-1.4|0.5695
73883405|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.391||||0.0003|TWO_SIDED|95.0|1.089|3.693|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.693|1.089|0.0003
74068572|NCT02247479|147689052|SUPERIORITY||Difference in Adjusted Means|0.3||||0.7865|TWO_SIDED|95.0|-1.7|2.3|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||2.3|-1.7|0.7865
74068573|NCT02247479|147689053|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9448|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.7|0.6|0.9448
74068574|NCT02247479|147689053|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8764|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.8|0.6|0.8764
73883406|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.404||||0.0004|TWO_SIDED|95.0|1.067|3.74|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.740|1.067|0.0004
74068575|NCT02247479|147689054|SUPERIORITY||Difference in Adjusted Means|5.66||||0.0991|TWO_SIDED|95.0|-1.07|12.38|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||12.38|-1.07|0.0991
74068576|NCT02247479|147689054|SUPERIORITY||Difference in Adjusted Means|-0.99||||0.7713|TWO_SIDED|95.0|-7.66|5.69|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||5.69|-7.66|0.7713
74068577|NCT02247479|147689055|SUPERIORITY||Difference in Adjusted Means|1.72||||0.6204|TWO_SIDED|95.0|-5.09|8.53|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.||8.53|-5.09|0.6204
74068578|NCT02247479|147689055|SUPERIORITY||Difference in Adjusted Means|1.47||||0.6705|TWO_SIDED|95.0|-5.31|8.25|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.||8.25|-5.31|0.6705
74068579|NCT02247479|147689056|SUPERIORITY||Difference in Adjusted Means|-0.36||||0.7246|TWO_SIDED|95.0|-2.35|1.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||1.64|-2.35|0.7246
74068580|NCT02247479|147689056|SUPERIORITY||Difference in Adjusted Means|-1.56||||0.1193|TWO_SIDED|95.0|-3.53|0.4|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.40|-3.53|0.1193
74068581|NCT02247479|147689057|SUPERIORITY||Difference in Adjusted Means|-0.22||||0.8659|TWO_SIDED|95.0|-2.84|2.39|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||2.39|-2.84|0.8659
74068582|NCT02247479|147689057|SUPERIORITY||Difference in Adjusted Means|-1.94||||0.1399|TWO_SIDED|95.0|-4.51|0.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.64|-4.51|0.1399
74068583|NCT02247479|147689058|SUPERIORITY||Difference in Adjusted Means|0.99||||0.4855|TWO_SIDED|95.0|-1.79|3.76|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.76|-1.79|0.4855
74068584|NCT02247479|147689058|SUPERIORITY||Difference in Adjusted Means|-1.6||||0.2515|TWO_SIDED|95.0|-4.33|1.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||1.13|-4.33|0.2515
74068585|NCT02247479|147689059|SUPERIORITY||Difference in Adjusted Means|-0.07||||0.2075|TWO_SIDED|95.0|-0.18|0.04|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.04|-0.18|0.2075
74068586|NCT02247479|147689059|SUPERIORITY||Difference in Adjusted Means|-0.08||||0.1222|TWO_SIDED|95.0|-0.19|0.02|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.02|-0.19|0.1222
74068587|NCT02247479|147689060|SUPERIORITY||Difference in Adjusted Means|-0.022||||0.8612|TWO_SIDED|95.0|-0.266|0.223|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.223|-0.266|0.8612
74068588|NCT02247479|147689060|SUPERIORITY||Difference in Adjusted Means|0.077||||0.5317|TWO_SIDED|95.0|-0.165|0.319|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.319|-0.165|0.5317
74068589|NCT02247479|147689060|SUPERIORITY||Difference in Adjusted Means|-0.033||||0.824|TWO_SIDED|95.0|-0.322|0.257|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.257|-0.322|0.8240
74068590|NCT02247479|147689060|SUPERIORITY||Difference in Adjusted Means|0.006||||0.9676|TWO_SIDED|95.0|-0.283|0.294|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.294|-0.283|0.9676
74068591|NCT01073020|147689061|SUPERIORITY||proportion|0.08||||0.6|TWO_SIDED||||||Chi-squared||Estimation parameter is the difference between the proportion of patients in the LAGB group vs. proportion of patients in the Intensive Medical Diabetes \& Weight Management (LAGB Grp) who achieved the primary outcome.|||||0.60
74068592|NCT01073020|147689061|SUPERIORITY||proportion|0.42||||0.005|TWO_SIDED||||||Chi-squared||Estimation parameter is the difference between the proportion of patients in the RYGB group vs. proportion of patients in the Intensive Medical Diabetes \& Weight Management (RYGB Grp) who achieved the primary outcome.|||||0.005
74068593|NCT01073020|147689062|SUPERIORITY||Mean Difference (Net)|1.0||||0.33|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in HbA1c in the LAGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline HbA1c.|||||0.33
74068594|NCT01073020|147689062|SUPERIORITY||Mean Difference (Net)|1.4|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in HbA1c in the RYGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline HbA1c.|||||<0.001
74068595|NCT01073020|147689063|SUPERIORITY||Mean Difference (Net)|2.2|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in BMI in the LAGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline BMI.|||||<0.001
74068596|NCT01073020|147689063|SUPERIORITY||Mean Difference (Net)|4.6|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in BMI in the RYGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline BMI.|||||<0.001
74068597|NCT01073020|147689064|SUPERIORITY||Mean Difference (Net)|1.5||||0.81|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in LAGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline CHD risk.|||||0.81
74068598|NCT01073020|147689064|SUPERIORITY||Mean Difference (Net)|2.6||||0.009|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in RYGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline CHD risk.|||||0.009
74068599|NCT01335477|147689065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|93.73|STANDARD_ERROR_OF_MEAN|24.907||0.0002||95.0|44.78|142.68||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix.~Nintedanib 150 mg bid versus Placebo."|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."||142.68|44.78|0.0002
74068600|NCT01335477|147689066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|1.151||0.0197||95.0|-4.95|-0.43|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.||-0.43|-4.95|0.0197
74068601|NCT01335477|147689067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.005||95.0|0.19|0.77|||Log Rank||Nintedanib 150 mg bid versus Placebo.|Hazard Ratio is based on a Cox's regression model with terms for treatment, gender, age and height.||0.77|0.19|0.0050
74068602|NCT01335477|147689068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|109.77|STANDARD_ERROR_OF_MEAN|19.808|<|0.0001||95.0|70.92|148.62|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||148.62|70.92|<0.0001
74068603|NCT01335477|147689069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.24|STANDARD_ERROR_OF_MEAN|0.742|<|0.0001||95.0|2.78|5.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||5.69|2.78|<0.0001
74068604|NCT01335477|147689070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06|STANDARD_ERROR_OF_MEAN|0.607|<|0.0001||95.0|1.87|4.25|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||4.25|1.87|<0.0001
74068605|NCT01335477|147689071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.21|STANDARD_ERROR_OF_MEAN|0.743|<|0.0001||95.0|2.76|5.67|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||5.67|2.76|<0.0001
74068606|NCT01335477|147689074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.286||||0.1833||95.0|0.89|1.86|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||1.86|0.89|0.1833
74068607|NCT01335477|147689075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.794||||0.0011||95.0|1.26|2.55|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted.||2.55|1.26|0.0011
74068608|NCT01335477|147689076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.664||||0.0218||95.0|1.08|2.57|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score||2.57|1.08|0.0218
74068609|NCT01335477|147689077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.675||0.4019||95.0|-4.69|1.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.||1.88|-4.69|0.4019
74068610|NCT01335477|147689078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08|STANDARD_ERROR_OF_MEAN|1.342||0.022||95.0|-5.71|-0.45|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ impact component-by-visit and random effect for patient||-0.45|-5.71|0.0220
74068611|NCT01335477|147689079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|1.36||0.0152||95.0|-5.97|-0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient||-0.64|-5.97|0.0152
74068612|NCT01335477|147689080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|1.192||0.0089||95.0|-5.46|-0.79|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.||-0.79|-5.46|0.0089
74068613|NCT01335477|147689081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|1.685||0.1587||95.0|-5.68|0.93|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.||0.93|-5.68|0.1587
74068614|NCT01335477|147689082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|STANDARD_ERROR_OF_MEAN|1.713||0.2326||95.0|-1.31|5.41|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.||5.41|-1.31|0.2326
74068615|NCT01335477|147689083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|1.564||0.2475||95.0|-1.26|4.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.||4.88|-1.26|0.2475
74068616|NCT01335477|147689084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.379||||0.069||95.0|0.98|1.95|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with term treatment||1.95|0.98|0.0690
74068617|NCT01335477|147689086|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.007||95.0|0.19|0.77|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150 mg bid versus Placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.||0.77|0.19|0.0070
74068618|NCT01335477|147689087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2995||95.0|0.4|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.||1.35|0.40|0.2995
74068619|NCT01335477|147689088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.6654||95.0|0.39|1.9|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.90|0.39|0.6654
74068620|NCT01335477|147689089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.2209||95.0|0.34|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.||1.35|0.34|0.2209
74068621|NCT01335477|147689090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.1664||95.0|0.37|1.21|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.21|0.37|0.1664
74068622|NCT01335477|147689091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2123||95.0|0.55|1.16|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.16|0.55|0.2123
74068623|NCT01335477|147689092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.213||0.2032||95.0|-0.15|0.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.||0.69|-0.15|0.2032
74068624|NCT01335477|147689093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.1005||0.26||95.0|-0.084|0.31|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) \[mmol/min/kPa\], baseline DLCO (HGB Corrected) \[mmol/min/kPa\]-by-visit and random effect for patient.||0.310|-0.084|0.2600
73888326|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|143.2|||<|0.0001|TWO_SIDED|95.0|78.0|208.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||208.4|78.0|<0.0001
74068625|NCT03031899|147689114|NON_INFERIORITY|"1. Rose bengal should stain the areas positively stained by Toluidine blue~2. areas stained by rose bengal that shows dysplasia in biopsy"|SN, SP, PPV, NPV|||||0.005|||||||Chi-squared|||||||0.005
74068626|NCT00094302|147689118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.14|TWO_SIDED|95.0|0.77|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 320 subjects in the Spironolactone group and 351 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.04|0.77|0.14
74068627|NCT00094302|147689119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.35|TWO_SIDED|95.0|0.73|1.12||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 336 subjects (160 in the Spironolactone group and 176 in the Placebo group) with a confirmed event."||1.12|0.73|0.35
74068628|NCT00094302|147689120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.48|TWO_SIDED|95.0|0.14|2.5||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 8 subjects (3 in the Spironolactone group and 5 in the Placebo group) with a confirmed event."||2.50|0.14|0.48
74068629|NCT00094302|147689121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.04|TWO_SIDED|95.0|0.69|0.99||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 451 subjects (206 in the Spironolactone group and 245 in the Placebo group) who have been confirmed to have experienced the event"||0.99|0.69|0.04
74068630|NCT00094302|147689122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.29|TWO_SIDED|95.0|0.77|1.08||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint compared by trial arm using logrank test of time to event from randomization. Subjects who did not experience endpoint were censored at time of last contact. Attempts were made to determine vital status as of each subject's last potential visit, based on randomization, even if the subject ended study participation before then. This outcome was adjudicated. There were 252 events over 6,022 patient-years in Spironolactone arm and 274 events over 5,981 patient-years in Placebo arm.||1.08|0.77|0.29
74068631|NCT00094302|147689123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.28|TWO_SIDED|95.0|0.8|1.06||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 382 subjects in Spironolactone group and 404 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.06|0.80|0.28
74068632|NCT00094302|147689124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.15|TWO_SIDED|95.0|0.76|1.04||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 291 subjects in Spironolactone group and 320 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.04|0.76|0.15
74068633|NCT00094302|147689125|SUPERIORITY_OR_OTHER||incidence rate ratio|0.75||||0.03|TWO_SIDED|95.0|0.58|0.97||No covariate adjustment|Negative binomial regression||Spironolactone compared to Placebo|There were a total of 869 confirmed heart failure hospitalizations (394 in the Spironolactone group and 475 in the Placebo group) during the 11,471 person-years collected over the course of the TOPCAT trial (5,755 person-years in the Spironolactone group and 5,716 person-years in the Placebo group). The incidence rate of heart failure hospitalizations for each treatment group was compared using a negative binomial regression with a p-value threshold of 0.05 for statistical significance.||0.97|0.58|0.03
74068634|NCT00094302|147689126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.82|TWO_SIDED|95.0|0.67|1.38||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 60 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.38|0.67|0.82
74068635|NCT00094302|147689127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.76|TWO_SIDED|95.0|0.64|1.83||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 56 subjects (29 in the Spironolactone group and 27 in the Placebo group) with confirmed events."||1.83|0.64|0.76
74068636|NCT00094302|147689128|SUPERIORITY_OR_OTHER||Hazard Ratio, log|1.02||||0.94|TWO_SIDED|95.0|0.69|1.5||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 103 subjects (52 in the Spironolactone group and 51 in the Placebo group) with confirmed events."||1.50|0.69|0.94
74068637|NCT00094302|147689129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.71|1.42||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 129 subjects (65 in the Spironolactone group and 64 in the Placebo group) with confirmed events."||1.42|0.71|0.98
74068638|NCT00094302|147689130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.73|TWO_SIDED|95.0|0.65|1.35||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 117 subjects (57 in the Spironolactone group and 60 in the Placebo group) with confirmed events."||1.35|0.65|0.73
74068639|NCT00094302|147689131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49|||<|0.01|TWO_SIDED|95.0|1.18|1.87||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were 295 subjects (175 in the Spironolactone group and 120 in the Placebo group) experiencing this endpoint. This endpoint did not undergo adjudication by the TOPCAT clinical endpoints committee."||1.87|1.18|<0.01
74068640|NCT00094302|147689132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.35||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 61 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.35|0.66|0.75
74068641|NCT00094302|147689133|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.27
74068642|NCT00094302|147689133|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
74068643|NCT00094302|147689134|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.87
74068644|NCT00094302|147689134|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.16
74068645|NCT00094302|147689135|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score and treatment group as predictor variables. This tests whether the value of the post-baseline quality of life parameter differs by treatment group.||||0.99
73883407|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.426||||0.0007|TWO_SIDED|95.0|1.027|3.825|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.825|1.027|0.0007
74068646|NCT00094302|147689136|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.39
73883408|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.439||||0.0009||95.0|1.005|3.872|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.872|1.005|0.0009
74068647|NCT00094302|147689136|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.01
74068648|NCT00094302|147689137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.25|TWO_SIDED|95.0|0.85|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were a total of 1558 subjects (766 subjects in the Spironolactone group and 792 subjects in the Placebo) who were hospitalized for any cause while on study. This endpoint was not adjudicated by the TOPCAT clinical endpoints committee."||1.04|0.85|0.25
74068649|NCT00094302|147689138|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.27
74068650|NCT00094302|147689138|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
74068651|NCT00094302|147689139|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.53
74068652|NCT00094302|147689139|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
74068653|NCT00094302|147689140|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.11
74068654|NCT00094302|147689140|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
74068655|NCT00094302|147689141|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.59
74068656|NCT00094302|147689141|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.54
74068657|NCT00094302|147689142|SUPERIORITY_OR_OTHER|||||||0.98|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.98
74068658|NCT00094302|147689142|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.02
74068659|NCT00006170|147689145|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.001|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.001
74068660|NCT00006170|147689145|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.25||95.0|||||Regression, Logistic|||||||0.25
74068661|NCT00006170|147689145|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.07||95.0|||||Regression, Logistic|||||||0.07
74068662|NCT00006170|147689146|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.|||||<|0.001||95.0|||||Regression, Logistic|||||||<0.001
74068663|NCT00006170|147689146|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.053||95.0|||||Regression, Logistic|||||||0.053
74068664|NCT00006170|147689146|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.08||95.0|||||Regression, Logistic|||||||0.08
74068665|NCT00006170|147689147|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.006||95.0|||||Regression, Logistic|||||||0.006
74068666|NCT00006170|147689147|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.45||95.0|||||Regression, Logistic|||||||0.45
74068667|NCT00006170|147689147|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.046||95.0|||||Regression, Logistic|||||||0.046
74068668|NCT01590433|147689153|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74068669|NCT02058628|147689163|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Data is represented as per CTR.|Wilcoxon (Mann-Whitney)|DUAC versus SKINOREN with a nominal alpha level of 5%, without adjustment for multiple comparisons.||||||0.0004
74068670|NCT01787825|147689227|NON_INFERIORITY|This is McNemar design.|percentage concordance|77.19||||1|TWO_SIDED|95.0|68.68|83.93||The blinded readers assessed concordance of normal versus abnormal and overall concordance of clinically significant abnormal images.|McNemar||Overall concordance of clinically significant abnormal images.|There was a comparison between normal and abnormal images. And detailed analysis of abnormal images that were considered clinical significant.||83.93|68.68|1.0000
74068671|NCT01787825|147689229|SUPERIORITY_OR_OTHER||percentage concordance|71.93||||0.972|TWO_SIDED|95.0|63.07|79.36|||Bowkers|||||79.36|63.07|0.972
74068672|NCT02422290|147689346|SUPERIORITY||Mean Difference (Final Values)|1.53|STANDARD_ERROR_OF_MEAN|1.83||0.2|TWO_SIDED|95.0|-2.27|7.87|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between CY-BOCS scores at the time points Baseline and Day 14.||7.87|-2.27|.20
73883409|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.461||||0.0013|TWO_SIDED|95.0|0.964|3.958|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.958|0.964|0.0013
74068673|NCT02422290|147689347|SUPERIORITY||Mean Difference (Final Values)|1.63|STANDARD_ERROR_OF_MEAN|0.49||0.18|TWO_SIDED|95.0|-0.56|2.16|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between CGI-S scores at the time points Baseline and Day 14.||2.16|-.56|.18
74068674|NCT02422290|147689348|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.0||1|TWO_SIDED|95.0|-2.78|2.78|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between OCD-VAS scores at the time points Baseline and Day 14.||2.78|-2.78|1.00
74068675|NCT02422290|147689349|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|5.41||0.77|TWO_SIDED|95.0|-15.46|18.96|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between OCD-VAS scores at the time points Baseline and Day 14.||18.96|-15.46|.77
73883410|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.474||||0.0016|TWO_SIDED|95.0|0.942|4.006|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.006|0.942|0.0016
73888327|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|126.7||||0.0002|TWO_SIDED|95.0|61.7|191.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||191.8|61.7|0.0002
74068676|NCT01842958|147689353|NON_INFERIORITY|The test arm will be considered non-inferior to the control arm if the 95% upper confidence interval of the estimated difference between the test and control arms is less than -0.5mm.||||||0.02|||||||ANCOVA|||The primary efficacy endpoint is change in crestal bone level from loading to 12 months post-loading. The primary analysis is a test for non-inferiority of the test implant to the control implant at the one-sided 5% significance level. The null hypothesis is that µ3.3 ≥ µ4.1 + δ, where µ3.3 is the mean change in crestal bone level for the test implants, µ4.1 is the mean change in crestal bone level for control implants, and δ is a pre-specified clinically significant difference.||||0.02
74068677|NCT00818623|147689367|SUPERIORITY_OR_OTHER_LEGACY|||||||5.86e-05||95.0|||||Log Rank|||||||0.0000586
73883411|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.496||||0.0022|TWO_SIDED|95.0|0.901|4.092|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.092|0.901|0.0022
74068678|NCT00818623|147689368|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Kruskal-Wallis|||||||0.0014
73883412|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.509||||0.0026|TWO_SIDED|95.0|0.878|4.14|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.140|0.878|0.0026
74068679|NCT00818623|147689368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|87.5||||||95.0|66.1|95.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||95.8|66.1|
74068680|NCT00818623|147689368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|66.7||||||95.0|33.7|86.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||86|33.7|
74068681|NCT00818623|147689368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|54.5||||||95.0|22.9|78.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||78|22.9|
74068682|NCT00818623|147689368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|100.0||||||95.0|85.8|100.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||100|85.8|
74068683|NCT00818623|147689368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|75.0||||||95.0|52.6|87.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||87.9|52.6|
74068684|NCT00818623|147689368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|95.7||||||95.0|72.9|99.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||99.4|72.9|
74068685|NCT00818623|147689368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|62.5||||||95.0|40.3|78.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||78.4|40.3|
74068686|NCT00818623|147689368|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|88.9||||||95.0|69.4|96.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||96.3|69.4|
74068687|NCT00818623|147689369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031||95.0|||||Kruskal-Wallis|||||||0.0031
74068688|NCT00818623|147689369|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|45.8||||||95.0|25.6|64.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||64|25.6|
74068689|NCT00818623|147689369|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|38.1||||||95.0|12.1|64.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||64.3|12.1|
74068690|NCT00818623|147689369|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|32.7||||||95.0|8.3|60.6||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||60.6|8.3|
74068691|NCT00818623|147689369|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|83.3||||||95.0|61.5|93.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||93.4|61.5|
74068692|NCT00818623|147689369|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|49.4||||||95.0|28.3|67.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||67.4|28.3|
74068693|NCT00818623|147689369|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|82.0||||||95.0|58.8|92.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||92.8|58.8|
74068694|NCT00818623|147689369|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|50.0||||||95.0|29.1|67.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||67.8|29.1|
74068695|NCT00818623|147689369|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|70.4||||||95.0|49.4|83.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||83.9|49.4|
74068696|NCT00818623|147689370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866||95.0|||||Log Rank|||||||0.0866
74068697|NCT00818623|147689371|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0|||||Log Rank|||||||0.033
74068698|NCT00818623|147689372|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131||95.0|||||Log Rank|||||||0.131
74068699|NCT00602030|147689376|SUPERIORITY||Adjusted Odds Ratio|0.72||||0.505|TWO_SIDED|95.0|0.27|1.89|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel estimation of odds ratio adjusted for the smoking history stratification factor, using placebo as reference group.|||1.89|0.27|0.505
74068700|NCT00602030|147689377|SUPERIORITY||Adjusted Odds Ratio|0.31||||0.13|TWO_SIDED|95.0|0.06|1.54|||Cochran-Mantel-Haenszel||Estimation of odds ratio was adjusted for the smoking history stratification factor, using placebo as reference group .|||1.54|0.06|0.13
74068701|NCT00602030|147689378|SUPERIORITY||Adjusted Odds Ratio|1.06||||0.918|TWO_SIDED|95.0|0.34|3.27|||Cochran-Mantel-Haenszel||Estimation of odds ratio was adjusted for the smoking history stratification factor, using placebo as reference group.|||3.27|0.34|0.918
74068702|NCT01832090|147689396|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74068703|NCT01832090|147689397|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74068704|NCT01832090|147689398|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74068705|NCT01832090|147689399|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74068706|NCT01832090|147689400|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
74068707|NCT01832090|147689401|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
74068708|NCT01832090|147689404|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74068709|NCT01832090|147689405|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74068710|NCT00543439|147689416|SUPERIORITY||Ratio of arithmetic means|0.03||||0.002|ONE_SIDED|95.0||0.08|||Paired t-test|||Ratio of the arithmetic means of the ABR for OD cohort: OD therapy to OD cohort: RP therapy 25 IU/kg was calculated. One-sided 95% CI for this ratio was reported.||0.08||0.0020
74068711|NCT00543439|147689417|EQUIVALENCE|90% 2-sided CI for the mean difference in ABRs for the 2 prophylaxis regimens for ITT participants was constructed using the t distribution with n-1 degrees of freedom (n equals the number of participants) to assess the equivalence of the 2 regimens. Equivalence was demonstrated and the null hypothesis rejected if the limits of the 90% CI fell wholly within the interval of (-4, 4) bleeds per year.|Mean Difference (Final Values)|1.1|||||TWO_SIDED|90.0|0.03|2.22||||||||2.22|0.03|
74068712|NCT01211769|147689439|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
74068713|NCT01211769|147689439|SUPERIORITY_OR_OTHER||Variance (F)|0.71||||0.69||95.0|||||ANOVA|||GROUP COMPARISON||||0.69
74068714|NCT01211769|147689440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
74068715|NCT01211769|147689440|SUPERIORITY_OR_OTHER||Variance (F)|0.73||||0.53||95.0|||||ANOVA|||GROUP COMPARISON||||0.53
74068716|NCT01211769|147689441|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
74068717|NCT01211769|147689441|SUPERIORITY_OR_OTHER||Variance (F)|1.08||||0.37||95.0|||||ANOVA|||GROUP COMPARISON||||0.37
74068718|NCT00926289|147689461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001||95.0|-10.6|-6.4|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-6.4|-10.6|<0.0001
74068719|NCT00926289|147689462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3|||<|0.0001||95.0|-9.3|-5.2|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-5.2|-9.3|<0.0001
74068720|NCT00926289|147689463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|||<|0.0001||95.0|-8.8|-4.7|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-4.7|-8.8|<0.0001
74068721|NCT00926289|147689464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001||95.0|-4.5|-1.9|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-1.9|-4.5|<0.0001
73883413|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.531||||0.0034|TWO_SIDED|95.0|0.836|4.226|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.226|0.836|0.0034
73883414|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.544||||0.004|TWO_SIDED|95.0|0.813|4.274|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.274|0.813|0.0040
74068722|NCT00926289|147689465|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.0001||95.0|1.74|3.21|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.21|1.74|<0.0001
74068723|NCT00926289|147689466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001||95.0|1.7|3.12|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.12|1.70|<0.0001
74068724|NCT00926289|147689467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19|||<|0.0001||95.0|1.6|3.01|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.01|1.60|<0.0001
74068725|NCT00926289|147689468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001||95.0|1.46|2.73|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||2.73|1.46|<0.0001
74068726|NCT00926289|147689469|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02|||<|0.0001||95.0|1.48|2.76|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||2.76|1.48|<0.0001
74068727|NCT00926289|147689470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.0005||95.0|1.28|2.37|||Regression, Logistic|Adjustment for continuous covariate of baseline and fixed effect country||T80+HCTZ25 versus T80 monotherapy||2.37|1.28|0.0005
74068728|NCT00926289|147689471|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001||95.0|1.76|3.26|||Regression, Logistic|Adjustment for continuous covariate of baseline (SBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.26|1.76|<0.0001
74068729|NCT00926289|147689472|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.0001||95.0|1.78|3.29|||Regression, Logistic|Adjustment for continuous covariate of baseline (DBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.29|1.78|<0.0001
74068730|NCT00926289|147689473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.0001||95.0|1.7|4.04|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||4.04|1.70|<0.0001
74068731|NCT00926289|147689474|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23|||<|0.0001||95.0|1.57|3.16|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.16|1.57|<0.0001
74068732|NCT00926289|147689475|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren test stratified for country|||T80+HCTZ25 versus T80 monotherapy||||<0.0001
74068733|NCT01070394|147689485|SUPERIORITY_OR_OTHER||||||<|0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||<.001
74068734|NCT01070394|147689486|SUPERIORITY_OR_OTHER|||||||0.569|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||.569
74068735|NCT01070394|147689486|SUPERIORITY_OR_OTHER|||||||0.827|||||||Generalized Estimating Equation|||The following p-value is for AMSES In-Clinic, a subset of the overall AMSES||||.827
74068736|NCT01070394|147689486|SUPERIORITY_OR_OTHER|||||||0.569|||||||Generalized Estimating Equation|||The following p-value is for AMSES, Evening, a subset of the AMSES||||.569
74068737|NCT01070394|147689487|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||GEE regression model|Generalized Estimating Equation (GEE)||||||.001
74068738|NCT01070394|147689488|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||GEE regression model|||||||<.001
74068739|NCT01070394|147689489|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||GEE regression model|Generalized Estimating Equation (GEE)||||||<.0001
74068740|NCT01070394|147689490|SUPERIORITY_OR_OTHER|||||||0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||0.001
74068741|NCT03280537|147689507|SUPERIORITY||Difference in Least Squares Means|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.014|TWO_SIDED|95.0|-1.05|-0.12||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.12|-1.05|0.0140
74068742|NCT03280537|147689508|SUPERIORITY||Difference in Least Squares Means|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0017|TWO_SIDED|95.0|-0.8|-0.19||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.19|-0.80|0.0017
74068743|NCT03280537|147689509|SUPERIORITY||Difference in Least Squares Means|-0.45|STANDARD_ERROR_OF_MEAN|0.14||0.0024|TWO_SIDED|95.0|-0.73|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.||-0.16|-0.73|0.0024
74068744|NCT03280537|147689510|SUPERIORITY||Difference in Least Squares Means|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.81|-0.27||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.||-0.27|-0.81|0.0001
74068745|NCT03280537|147689511|SUPERIORITY||Difference in Least Squares Means|-0.91|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.39|-0.44||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.||-0.44|-1.39|0.0002
74068746|NCT03280537|147689512|SUPERIORITY||Difference in Least Squares Means|-0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.3||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.||-0.30|-0.87|<0.0001
74068747|NCT03280537|147689513|SUPERIORITY||Difference in Least Squares Means|-15.04|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001|TWO_SIDED|95.0|-21.26|-8.82||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.||-8.82|-21.26|<0.0001
74068748|NCT03280537|147689514|SUPERIORITY||Difference in Least Squares Means|-0.63|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.35||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.||-0.35|-0.90|<0.0001
74068749|NCT03280537|147689515|SUPERIORITY||Odds Ratio (OR)|0.2||||0.1594|TWO_SIDED|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.||1.89|0.02|0.1594
74068750|NCT03280537|147689516|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|20.61||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.||20.61|0.00|1.0000
74068751|NCT03280537|147689517|SUPERIORITY||Odds Ratio (OR)|4.04||||0.0396|TWO_SIDED|95.0|1.07|15.25|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.||15.25|1.07|0.0396
74068752|NCT03280537|147689518|SUPERIORITY||Odds Ratio (OR)|0.2||||0.1594|TWO_SIDED|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.||1.89|0.02|0.1594
74068753|NCT03280537|147689519|SUPERIORITY||Odds Ratio (OR)|6.22||||0.0139|TWO_SIDED|95.0|1.23|60.23||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.||60.23|1.23|0.0139
74068754|NCT03280537|147689520|SUPERIORITY||Difference in Least Squares Means|-2.09|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.0|-1.18||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.||-1.18|-3.00|<0.0001
74068755|NCT03280537|147689521|SUPERIORITY||Difference in Least Squares Means|3.86|STANDARD_ERROR_OF_MEAN|1.16||0.0011|TWO_SIDED|95.0|1.57|6.15||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.||6.15|1.57|0.0011
74068756|NCT03118739|147689537|SUPERIORITY||Mean % Change from Baseline|-39.37|||||TWO_SIDED|90.0|-61.785|-3.814||||||||-3.814|-61.785|
74068757|NCT04527471|147689641|OTHER|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1
74068758|NCT00096265|147689687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.93|TWO_SIDED|95.0|0.89|2.31||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.||2.31|0.89|0.93
74068759|NCT00096265|147689687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.95|TWO_SIDED|95.0|0.92|2.36||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.||2.36|0.92|0.95
74068760|NCT00096265|147689688|SUPERIORITY|||||||0.3|||||||Gray's test|||||||0.30
74068761|NCT00096265|147689688|SUPERIORITY|||||||0.48|||||||Gray's test|||||||0.48
74068762|NCT00096265|147689690|SUPERIORITY|||||||0.39|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0702.||||0.39
74068763|NCT00096265|147689690|SUPERIORITY|||||||0.28|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0702.||||0.28
74068764|NCT00096265|147689691|SUPERIORITY|||||||0.002|||||||Chi-squared|||108 with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0586.||||0.002
74068765|NCT00096265|147689691|SUPERIORITY||||||<|0.001|||||||Chi-squared|||108 cases with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0586.||||< 0.001
74068766|NCT00096265|147689692|SUPERIORITY|Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.1217.||||||0.51|||||||Chi-squared|||||||0.51
73883415|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.566||||0.0051|TWO_SIDED|95.0|0.772|4.361|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.361|0.772|0.0051
74068767|NCT00096265|147689692|SUPERIORITY|||||||0.56|||||||Chi-squared|||Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.1217.||||0.56
74068768|NCT00096265|147689693|SUPERIORITY|||||||0.78|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.||||0.78
74068769|NCT00096265|147689693|SUPERIORITY|||||||0.8|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.||||0.80
74068770|NCT01506323|147689694|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline (week 0) to post-treatment (week 8). Cronbach's alpha for this study was .92 at baseline.||||<.006
74068771|NCT01506323|147689694|SUPERIORITY_OR_OTHER||repeated measures||||<|0.031|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using false discovery rate.|Mixed Models Analysis|This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.||This analysis is from baseline (week 0) to 2 months follow-up.||||<.031
74068772|NCT01506323|147689695|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||The p-value is based on false discovery rate adjustment for multiple comparisons.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .86 at baseline.||||0.82
74068773|NCT01506323|147689695|SUPERIORITY_OR_OTHER|||||||0.82|ONE_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment.||||0.82
74068774|NCT01506323|147689696|SUPERIORITY_OR_OTHER||||||<|0.008|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .85 at baseline.||||<0.008
74068775|NCT01506323|147689696|SUPERIORITY_OR_OTHER||||||<|0.09|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment||||<0.09
74068776|NCT01506323|147689697|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .78 at baseline.||||<.006
74068777|NCT01506323|147689697|SUPERIORITY_OR_OTHER||||||<|0.03|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to 2 months post-treatment.||||<.03
74068778|NCT01506323|147689698|SUPERIORITY_OR_OTHER||||||<|0.0008|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.||||<0.0008
74068779|NCT01506323|147689698|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Wilcoxon (Mann-Whitney)|||This analysis is from baseline to 2 months post-treatment.||||<0.006
74068780|NCT01506323|147689699|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. Raw p-value was \<0.02.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score in this study was .86 at baseline.||||<0.10
74068781|NCT01506323|147689699|SUPERIORITY_OR_OTHER||||||<|0.49|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment.||||<0.49
74068782|NCT01506323|147689700|SUPERIORITY_OR_OTHER||||||<|0.78|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .96 at baseline.||||<0.78
74068783|NCT01506323|147689700|SUPERIORITY_OR_OTHER||||||<|0.99|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.99
74068784|NCT01506323|147689701|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis was from baseline to post-treatment. Cronbach's alpha for this study was .92 at baseline.||||<0.04
74068785|NCT01506323|147689701|SUPERIORITY_OR_OTHER||||||<|0.25|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.25
74068786|NCT01506323|147689702|SUPERIORITY_OR_OTHER||||||<|0.99|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.||||<0.99
74068787|NCT01506323|147689702|SUPERIORITY_OR_OTHER||||||<|0.94|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.94
74068788|NCT01506323|147689703|SUPERIORITY_OR_OTHER||||||<|0.12|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .88 at baseline.||||<0.12
74068789|NCT01506323|147689703|SUPERIORITY_OR_OTHER||||||<|0.49|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.49
74068790|NCT01506323|147689704|SUPERIORITY_OR_OTHER||||||<|0.59|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score was .89 at baseline.||||<0.59
74068791|NCT01506323|147689704|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline to 2-months post-treatment.||||<0.10
74068792|NCT02891200|147689705|SUPERIORITY||Predicted Mean Difference|1.46||||0.467|TWO_SIDED|95.0|-2.47|5.38|||Mixed Models Analysis|Mixed effects linear model with study site and setting as fixed effects, and adjusted for baseline SGRQ domain scores.||||5.38|-2.47|0.467
74068793|NCT00810732|147689722|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.94|-0.19|||ANCOVA|||||-0.19|-0.94|0.0040
74068794|NCT00810732|147689722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.0018|TWO_SIDED|95.0|-0.99|-0.24|||ANCOVA|||||-0.24|-0.99|0.0018
74068795|NCT00810732|147689722|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.19||0.7945|TWO_SIDED|95.0|-0.33|0.43|||ANCOVA|||||0.43|-0.33|0.7945
74068796|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|1.3||0.0087|TWO_SIDED|95.0|-6.08|-0.91|||ANCOVA|||Mean Systemic Arterial BP: Week 3||-0.91|-6.08|0.0087
74068797|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.92|STANDARD_ERROR_OF_MEAN|1.3||0.1424|TWO_SIDED|95.0|-4.5|0.66|||ANCOVA|||Mean Systemic Arterial BP: Week 3||0.66|-4.50|0.1424
74068798|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.29||0.2277|TWO_SIDED|95.0|-4.15|1.0|||ANCOVA|||Mean Systemic Arterial BP: Week 3||1.00|-4.15|0.2277
74068799|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.81||0.1599|TWO_SIDED|95.0|-6.16|1.03|||ANCOVA|||Systolic Blood Pressure: Week 3||1.03|-6.16|0.1599
74068800|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|STANDARD_ERROR_OF_MEAN|1.8||0.5545|TWO_SIDED|95.0|-4.66|2.52|||ANCOVA|||Systolic Blood Pressure: Week 3||2.52|-4.66|0.5545
74068801|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.49|STANDARD_ERROR_OF_MEAN|1.8||0.4095|TWO_SIDED|95.0|-5.08|2.09|||ANCOVA|||Systolic Blood Pressure: Week 3||2.09|-5.08|0.4095
74068802|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.08|STANDARD_ERROR_OF_MEAN|1.21||0.0012|TWO_SIDED|95.0|-6.49|-1.67|||ANCOVA|||Diastolic Blood Pressure: Week 3||-1.67|-6.49|0.0012
74068803|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.98|STANDARD_ERROR_OF_MEAN|1.21||0.0159|TWO_SIDED|95.0|-5.38|-0.57|||ANCOVA|||Diastolic Blood Pressure: Week 3||-0.57|-5.38|0.0159
74068804|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.21||0.3627|TWO_SIDED|95.0|-3.51|1.3|||ANCOVA|||Diastolic Blood Pressure: Week 3||1.30|-3.51|0.3627
74068805|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.36|STANDARD_ERROR_OF_MEAN|1.16||0.0057|TWO_SIDED|95.0|-5.69|-1.03|||ANCOVA|||Mean Systemic Arterial BP: Week 6||-1.03|-5.69|0.0057
74068806|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.16||0.6503|TWO_SIDED|95.0|-2.86|1.8|||ANCOVA|||Mean Systemic Arterial BP: Week 6||1.80|-2.86|0.6503
74068807|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.83|STANDARD_ERROR_OF_MEAN|1.16||0.0183|TWO_SIDED|95.0|-5.16|-0.5|||ANCOVA|||Mean Systemic Arterial BP: Week 6||-0.50|-5.16|0.0183
74068808|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.81|STANDARD_ERROR_OF_MEAN|1.53||0.0726|TWO_SIDED|95.0|-5.89|0.27|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||0.27|-5.89|0.0726
74068809|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|1.53||0.9661|TWO_SIDED|95.0|-3.01|3.14|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||3.14|-3.01|0.9661
74068810|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.88|STANDARD_ERROR_OF_MEAN|1.53||0.0656|TWO_SIDED|95.0|-5.94|0.19|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||0.19|-5.94|0.0656
74068811|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.16|STANDARD_ERROR_OF_MEAN|1.11||0.0068|TWO_SIDED|95.0|-5.39|-0.92|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||-0.92|-5.39|0.0068
74068812|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.11||0.376|TWO_SIDED|95.0|-3.22|1.24|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||1.24|-3.22|0.3760
74068813|NCT00810732|147689723|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.16|STANDARD_ERROR_OF_MEAN|1.11||0.0572|TWO_SIDED|95.0|-4.4|0.07|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||0.07|-4.40|0.0572
74068814|NCT00810732|147689724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8823|TWO_SIDED|95.0|-0.39|0.45|||ANCOVA|||Week 3||0.45|-0.39|0.8823
74068815|NCT00810732|147689724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.21||0.9457|TWO_SIDED|95.0|-0.41|0.43|||ANCOVA|||Week 3||0.43|-0.41|0.9457
74068816|NCT00810732|147689724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.21||0.9358|TWO_SIDED|95.0|-0.4|0.44|||ANCOVA|||Week 3||0.44|-0.40|0.9358
74068817|NCT00810732|147689724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.0022|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Week 6||-0.25|-1.03|0.0022
74068818|NCT00810732|147689724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.8956|TWO_SIDED|95.0|-0.41|0.36|||ANCOVA|||Week 6||0.36|-0.41|0.8956
74068819|NCT00810732|147689724|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|-1.0|-0.23|||ANCOVA|||Week 6||-0.23|-1.00|0.0030
74068820|NCT01633827|147689731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
74068821|NCT01633827|147689732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.025|TWO_SIDED||||||t-test, 2 sided|||||||0.025
74068822|NCT01633827|147689733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
74068823|NCT01633827|147689734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
74068824|NCT01633827|147689735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
74068825|NCT02637557|147689751|SUPERIORITY||LS Mean Difference|-2.952||||0.6065|TWO_SIDED|95.0|-14.222|8.318||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||8.318|-14.222|0.6065
74068826|NCT02637557|147689751|SUPERIORITY||LS Mean Difference|-9.036||||0.116|TWO_SIDED|95.0|-20.318|2.245||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||2.245|-20.318|0.1160
74068827|NCT02637557|147689751|SUPERIORITY||LS Mean Difference|-11.943||||0.04|TWO_SIDED|95.0|-23.334|-0.551||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||-0.551|-23.334|0.0400
74068828|NCT02637557|147689751|SUPERIORITY|||||||0.0225||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.0225
74068829|NCT02637557|147689752|SUPERIORITY||LS Mean Difference|-3.711||||0.4795|TWO_SIDED|95.0|-14.028|6.606||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||6.606|-14.028|0.4795
74068830|NCT02637557|147689752|SUPERIORITY||LS Mean Difference|-2.739||||0.602|TWO_SIDED|95.0|-13.066|7.588||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||7.588|-13.066|0.6020
74068831|NCT02637557|147689752|SUPERIORITY||LS Mean Difference|-8.602||||0.1055|TWO_SIDED|95.0|-19.03|1.826||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.826|-19.030|0.1055
74068832|NCT02637557|147689752|SUPERIORITY|||||||0.1387||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.1387
74068833|NCT02637557|147689753|SUPERIORITY||LS Mean Difference|-0.058||||0.7488|TWO_SIDED|95.0|-0.415|0.299||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.299|-0.415|0.7488
74068834|NCT02637557|147689753|SUPERIORITY||LS Mean Difference|-0.254||||0.1627|TWO_SIDED|95.0|-0.611|0.103||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.103|-0.611|0.1627
74068835|NCT02637557|147689753|SUPERIORITY||LS Mean Difference|-0.417||||0.0237|TWO_SIDED|95.0|-0.777|-0.056||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||-0.056|-0.777|0.0237
74068836|NCT02637557|147689753|SUPERIORITY|||||||0.013||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.0130
74068837|NCT02637557|147689754|SUPERIORITY||LS Mean Difference|-0.052||||0.747|TWO_SIDED|95.0|-0.369|0.265||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.265|-0.369|0.7470
74068838|NCT02637557|147689754|SUPERIORITY||LS Mean Difference|-0.047||||0.7699|TWO_SIDED|95.0|-0.364|0.27||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.270|-0.364|0.7699
74068839|NCT02637557|147689754|SUPERIORITY||LS Mean Difference|-0.257||||0.1157|TWO_SIDED|95.0|-0.577|0.064||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.064|-0.577|0.1157
74068840|NCT02637557|147689754|SUPERIORITY|||||||0.1374||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.1374
74068841|NCT02637557|147689755|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7903|TWO_SIDED|95.0|0.47|1.77||Odds ratio, 95% confidence interval (CI) for the odds ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||1.77|0.47|0.7903
74068842|NCT02637557|147689755|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3518|TWO_SIDED|95.0|0.7|2.71||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||2.71|0.70|0.3518
74068843|NCT02637557|147689755|SUPERIORITY||Odds Ratio (OR)|1.64||||0.1544|TWO_SIDED|95.0|0.83|3.26||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.26|0.83|0.1544
74068844|NCT02637557|147689756|SUPERIORITY||Odds Ratio (OR)|0.56||||0.1489|TWO_SIDED|95.0|0.25|1.23||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||1.23|0.25|0.1489
74068845|NCT02637557|147689756|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8891|TWO_SIDED|95.0|0.51|2.19||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||2.19|0.51|0.8891
74068846|NCT02637557|147689756|SUPERIORITY||Odds Ratio (OR)|1.56||||0.2237|TWO_SIDED|95.0|0.76|3.2||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.20|0.76|0.2237
74068847|NCT02637557|147689757|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6566|TWO_SIDED|95.0|0.48|3.18||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.18|0.48|0.6566
74068848|NCT02637557|147689757|SUPERIORITY||Odds Ratio (OR)|2.01||||0.128|TWO_SIDED|95.0|0.81|4.98||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||4.98|0.81|0.1280
74068849|NCT02637557|147689757|SUPERIORITY||Odds Ratio (OR)|1.97||||0.1463|TWO_SIDED|95.0|0.79|4.91||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||4.91|0.79|0.1463
74068850|NCT02637557|147689758|SUPERIORITY||LS Mean Difference|-0.298||||0.5504|TWO_SIDED|95.0|-1.279|0.683||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.683|-1.279|0.5504
74068851|NCT02637557|147689758|SUPERIORITY||LS Mean Difference|0.252||||0.6177|TWO_SIDED|95.0|-0.741|1.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.244|-0.741|0.6177
74068852|NCT02637557|147689758|SUPERIORITY||LS Mean Difference|0.513||||0.3138|TWO_SIDED|95.0|-0.488|1.513||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.513|-0.488|0.3138
74068853|NCT02637557|147689759|SUPERIORITY||LS Mean Difference|0.019||||0.9675|TWO_SIDED|95.0|-0.897|0.935||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.935|-0.897|0.9675
74068854|NCT02637557|147689759|SUPERIORITY||LS Mean Difference|0.419||||0.3741|TWO_SIDED|95.0|-0.507|1.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.345|-0.507|0.3741
74068855|NCT02637557|147689759|SUPERIORITY||LS Mean Difference|0.461||||0.3275|TWO_SIDED|95.0|-0.464|1.385||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.385|-0.464|0.3275
74068856|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|0.023||||0.856|TWO_SIDED|95.0|-0.226|0.272||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.272|-0.226|0.8560
74068857|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|0.124||||0.3301|TWO_SIDED|95.0|-0.126|0.373||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.373|-0.126|0.3301
74068858|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.019||||0.8845|TWO_SIDED|95.0|-0.27|0.233||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.233|-0.270|0.8845
74068859|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|0.02||||0.8879|TWO_SIDED|95.0|-0.262|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.303|-0.262|0.8879
74068860|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|0.017||||0.9072|TWO_SIDED|95.0|-0.266|0.299||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.299|-0.266|0.9072
74068861|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.108||||0.4573|TWO_SIDED|95.0|-0.393|0.177||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.177|-0.393|0.4573
74068862|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.049||||0.7476|TWO_SIDED|95.0|-0.35|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.251|-0.350|0.7476
74068863|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.062||||0.6873|TWO_SIDED|95.0|-0.362|0.239||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.239|-0.362|0.6873
74068864|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.258||||0.0952|TWO_SIDED|95.0|-0.562|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.045|-0.562|0.0952
74068865|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.018||||0.9111|TWO_SIDED|95.0|-0.326|0.291||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.291|-0.326|0.9111
74068866|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|0.004||||0.9772|TWO_SIDED|95.0|-0.304|0.313||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.313|-0.304|0.9772
74068867|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.235||||0.139|TWO_SIDED|95.0|-0.546|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.077|-0.546|0.1390
74068868|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.017||||0.9215|TWO_SIDED|95.0|-0.349|0.316||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.316|-0.349|0.9215
74068869|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.055||||0.7453|TWO_SIDED|95.0|-0.388|0.278||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.278|-0.388|0.7453
74068870|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.393||||0.022|TWO_SIDED|95.0|-0.729|-0.057||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.057|-0.729|0.0220
74068871|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|0.053||||0.7561|TWO_SIDED|95.0|-0.282|0.387||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.387|-0.282|0.7561
74068872|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.071||||0.6758|TWO_SIDED|95.0|-0.406|0.263||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.263|-0.406|0.6758
74068873|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.348||||0.0434|TWO_SIDED|95.0|-0.686|-0.01||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.010|-0.686|0.0434
74068874|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|0.042||||0.8123|TWO_SIDED|95.0|-0.308|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.392|-0.308|0.8123
74068875|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.044||||0.8038|TWO_SIDED|95.0|-0.394|0.306||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.306|-0.394|0.8038
74068876|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.3||||0.0954|TWO_SIDED|95.0|-0.654|0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.053|-0.654|0.0954
73883416|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.579||||0.0058|TWO_SIDED|95.0|0.748|4.41|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.410|0.748|0.0058
74068877|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.078||||0.6649|TWO_SIDED|95.0|-0.43|0.275||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.275|-0.430|0.6649
74068878|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.262||||0.1448|TWO_SIDED|95.0|-0.614|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.091|-0.614|0.1448
74068879|NCT02637557|147689760|SUPERIORITY||LS Mean Difference|-0.403||||0.0264|TWO_SIDED|95.0|-0.759|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.048|-0.759|0.0264
74068880|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|0.102||||0.4137|TWO_SIDED|95.0|-0.143|0.347||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.347|-0.143|0.4137
74068881|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|0.147||||0.2395|TWO_SIDED|95.0|-0.098|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.392|-0.098|0.2395
74068882|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.036||||0.7729|TWO_SIDED|95.0|-0.284|0.212||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.212|-0.284|0.7729
74068883|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|0.079||||0.5824|TWO_SIDED|95.0|-0.205|0.363||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.363|-0.205|0.5824
74068884|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|0.028||||0.8466|TWO_SIDED|95.0|-0.256|0.312||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.312|-0.256|0.8466
74068885|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.118||||0.4192|TWO_SIDED|95.0|-0.405|0.169||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.169|-0.405|0.4192
74068886|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.035||||0.8192|TWO_SIDED|95.0|-0.333|0.264||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.264|-0.333|0.8192
74068887|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.073||||0.632|TWO_SIDED|95.0|-0.372|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.226|-0.372|0.6320
74068888|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.345||||0.0254|TWO_SIDED|95.0|-0.647|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.043|-0.647|0.0254
74068889|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.047||||0.7689|TWO_SIDED|95.0|-0.36|0.266||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.266|-0.360|0.7689
74068890|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.117||||0.4631|TWO_SIDED|95.0|-0.43|0.196||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.196|-0.430|0.4631
73888328|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|202.4|||<|0.0001|TWO_SIDED|95.0|118.4|286.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||286.4|118.4|<0.0001
74068891|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.298||||0.0651|TWO_SIDED|95.0|-0.615|0.019||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.019|-0.615|0.0651
74068892|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.06||||0.7197|TWO_SIDED|95.0|-0.392|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.271|-0.392|0.7197
74068893|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.097||||0.5649|TWO_SIDED|95.0|-0.428|0.234||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.234|-0.428|0.5649
74068894|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.422||||0.0138|TWO_SIDED|95.0|-0.757|-0.087||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.087|-0.757|0.0138
74068895|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|0.06||||0.7202|TWO_SIDED|95.0|-0.269|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.388|-0.269|0.7202
74068896|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.093||||0.5784|TWO_SIDED|95.0|-0.421|0.236||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.236|-0.421|0.5784
74068897|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.376||||0.0266|TWO_SIDED|95.0|-0.708|-0.044||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.044|-0.708|0.0266
74068898|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.049||||0.777|TWO_SIDED|95.0|-0.391|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.293|-0.391|0.7770
74068899|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.114||||0.5121|TWO_SIDED|95.0|-0.456|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.228|-0.456|0.5121
74068900|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.366||||0.0384|TWO_SIDED|95.0|-0.711|-0.02||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.020|-0.711|0.0384
74068901|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.093||||0.5876|TWO_SIDED|95.0|-0.431|0.245||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.245|-0.431|0.5876
74068902|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.298||||0.0842|TWO_SIDED|95.0|-0.636|0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.040|-0.636|0.0842
74068903|NCT02637557|147689761|SUPERIORITY||LS Mean Difference|-0.452||||0.0098|TWO_SIDED|95.0|-0.793|-0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.110|-0.793|0.0098
74068904|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|0.054||||0.6663|TWO_SIDED|95.0|-0.193|0.301||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.301|-0.193|0.6663
74068905|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|0.148||||0.24|TWO_SIDED|95.0|-0.1|0.396||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.396|-0.100|0.2400
74068906|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.023||||0.856|TWO_SIDED|95.0|-0.273|0.227||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.227|-0.273|0.8560
74068907|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|0.051||||0.7209|TWO_SIDED|95.0|-0.232|0.335||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.335|-0.232|0.7209
74068908|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.013||||0.9283|TWO_SIDED|95.0|-0.297|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.271|-0.297|0.9283
73888329|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|137.6||||0.0015|TWO_SIDED|95.0|53.3|221.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||221.8|53.3|0.0015
74068909|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.162||||0.2659|TWO_SIDED|95.0|-0.449|0.124||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.124|-0.449|0.2659
74068910|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.006||||0.968|TWO_SIDED|95.0|-0.31|0.298||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.298|-0.310|0.9680
74068911|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.125||||0.4213|TWO_SIDED|95.0|-0.429|0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.180|-0.429|0.4213
74068912|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.311||||0.0471|TWO_SIDED|95.0|-0.618|-0.004||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.004|-0.618|0.0471
74068913|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.025||||0.8769|TWO_SIDED|95.0|-0.337|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.288|-0.337|0.8769
74068914|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.059||||0.7109|TWO_SIDED|95.0|-0.372|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.254|-0.372|0.7109
74068915|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.254||||0.1146|TWO_SIDED|95.0|-0.57|0.062||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.062|-0.570|0.1146
74068916|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|0.048||||0.7736|TWO_SIDED|95.0|-0.281|0.378||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.378|-0.281|0.7736
74068917|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.02||||0.9059|TWO_SIDED|95.0|-0.35|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.310|-0.350|0.9059
74068918|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.299||||0.0779|TWO_SIDED|95.0|-0.633|0.034||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.034|-0.633|0.0779
74068919|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|0.086||||0.6068|TWO_SIDED|95.0|-0.241|0.412||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.412|-0.241|0.6068
74068920|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.024||||0.8838|TWO_SIDED|95.0|-0.352|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.303|-0.352|0.8838
74068921|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.323||||0.0556|TWO_SIDED|95.0|-0.653|0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.008|-0.653|0.0556
74068922|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.051||||0.7673|TWO_SIDED|95.0|-0.389|0.287||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.287|-0.389|0.7673
74068923|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.05||||0.7709|TWO_SIDED|95.0|-0.389|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.289|-0.389|0.7709
74068924|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.386||||0.0273|TWO_SIDED|95.0|-0.728|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.043|-0.728|0.0273
74068925|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.044||||0.795|TWO_SIDED|95.0|-0.378|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.289|-0.378|0.7950
74068926|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.236||||0.1656|TWO_SIDED|95.0|-0.57|0.098||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.098|-0.570|0.1656
74068927|NCT02637557|147689762|SUPERIORITY||LS Mean Difference|-0.385||||0.0254|TWO_SIDED|95.0|-0.722|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.048|-0.722|0.0254
74068928|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|0.093||||0.3788|TWO_SIDED|95.0|-0.114|0.3||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.300|-0.114|0.3788
74068929|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|0.189||||0.0761|TWO_SIDED|95.0|-0.02|0.397||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.397|-0.020|0.0761
74068930|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.021||||0.8415|TWO_SIDED|95.0|-0.232|0.189||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.189|-0.232|0.8415
74068931|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|0.052||||0.6719|TWO_SIDED|95.0|-0.19|0.294||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.294|-0.190|0.6719
74068932|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|0.007||||0.9549|TWO_SIDED|95.0|-0.237|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.251|-0.237|0.9549
74068933|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.096||||0.4408|TWO_SIDED|95.0|-0.342|0.149||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.149|-0.342|0.4408
74068934|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.004||||0.9736|TWO_SIDED|95.0|-0.262|0.253||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.253|-0.262|0.9736
74068935|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.146||||0.2703|TWO_SIDED|95.0|-0.405|0.114||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.114|-0.405|0.2703
74068936|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.351||||0.0087|TWO_SIDED|95.0|-0.612|-0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.089|-0.612|0.0087
74068937|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.026||||0.848|TWO_SIDED|95.0|-0.295|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.243|-0.295|0.8480
74068938|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.073||||0.5966|TWO_SIDED|95.0|-0.344|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.198|-0.344|0.5966
74068939|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.324||||0.0203|TWO_SIDED|95.0|-0.596|-0.051||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.051|-0.596|0.0203
74068940|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.025||||0.854|TWO_SIDED|95.0|-0.294|0.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.244|-0.294|0.8540
74068941|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.022||||0.8757|TWO_SIDED|95.0|-0.293|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.250|-0.293|0.8757
74068942|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.332||||0.0174|TWO_SIDED|95.0|-0.605|-0.059||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.059|-0.605|0.0174
74068943|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|0.078||||0.5831|TWO_SIDED|95.0|-0.202|0.358||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.358|-0.202|0.5831
74068944|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.078||||0.5859|TWO_SIDED|95.0|-0.36|0.204||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.204|-0.360|0.5859
74068945|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.291||||0.0447|TWO_SIDED|95.0|-0.575|-0.007||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.007|-0.575|0.0447
74068946|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|0.093||||0.5365|TWO_SIDED|95.0|-0.203|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.388|-0.203|0.5365
74068947|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.057||||0.7067|TWO_SIDED|95.0|-0.355|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.241|-0.355|0.7067
74068948|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.317||||0.0386|TWO_SIDED|95.0|-0.616|-0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.017|-0.616|0.0386
74068949|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|0.042||||0.7804|TWO_SIDED|95.0|-0.253|0.336||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.336|-0.253|0.7804
73888330|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|192.9|||<|0.0001|TWO_SIDED|95.0|108.7|277.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||277.2|108.7|<0.0001
74068950|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.125||||0.4064|TWO_SIDED|95.0|-0.422|0.171||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.171|-0.422|0.4064
74068951|NCT02637557|147689763|SUPERIORITY||LS Mean Difference|-0.333||||0.0289|TWO_SIDED|95.0|-0.632|-0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.035|-0.632|0.0289
74068952|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|0.037||||0.7207|TWO_SIDED|95.0|-0.167|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.241|-0.167|0.7207
74068953|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.071||||0.4946|TWO_SIDED|95.0|-0.275|0.133||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.133|-0.275|0.4946
74068954|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.077||||0.4596|TWO_SIDED|95.0|-0.283|0.129||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.129|-0.283|0.4596
74068955|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|0.067||||0.5987|TWO_SIDED|95.0|-0.182|0.315||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.315|-0.182|0.5987
73883417|NCT00083889|147300792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.602||||0.0071|TWO_SIDED|95.0|0.706|4.497|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.497|0.706|0.0071
74068956|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.122||||0.3348|TWO_SIDED|95.0|-0.372|0.127||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.127|-0.372|0.3348
74068957|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.062||||0.6288|TWO_SIDED|95.0|-0.313|0.19||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.190|-0.313|0.6288
74068958|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.048||||0.7193|TWO_SIDED|95.0|-0.312|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.216|-0.312|0.7193
74068959|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.27||||0.0452|TWO_SIDED|95.0|-0.534|-0.006||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.006|-0.534|0.0452
74068960|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.252||||0.0635|TWO_SIDED|95.0|-0.519|0.014||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.014|-0.519|0.0635
74068961|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.126||||0.38|TWO_SIDED|95.0|-0.409|0.156||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.156|-0.409|0.3800
74068962|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.336||||0.02|TWO_SIDED|95.0|-0.62|-0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.053|-0.620|0.0200
74068963|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.328||||0.0244|TWO_SIDED|95.0|-0.614|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.043|-0.614|0.0244
74068964|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.096||||0.5232|TWO_SIDED|95.0|-0.392|0.2||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.200|-0.392|0.5232
74068965|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.282||||0.0623|TWO_SIDED|95.0|-0.579|0.015||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.015|-0.579|0.0623
74068966|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.255||||0.0951|TWO_SIDED|95.0|-0.554|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.045|-0.554|0.0951
74068967|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.06||||0.6985|TWO_SIDED|95.0|-0.363|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.243|-0.363|0.6985
74068968|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.373||||0.0163|TWO_SIDED|95.0|-0.677|-0.069||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.069|-0.677|0.0163
74068969|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.345||||0.0273|TWO_SIDED|95.0|-0.652|-0.039||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.039|-0.652|0.0273
74068970|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.056||||0.7187|TWO_SIDED|95.0|-0.362|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.250|-0.362|0.7187
74068971|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.29||||0.064|TWO_SIDED|95.0|-0.596|0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.017|-0.596|0.0640
74068972|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.484||||0.0023|TWO_SIDED|95.0|-0.793|-0.175||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.175|-0.793|0.0023
74068973|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.079||||0.6033|TWO_SIDED|95.0|-0.378|0.22||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.220|-0.378|0.6033
74068974|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.35||||0.0222|TWO_SIDED|95.0|-0.65|-0.05||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.050|-0.650|0.0222
74068975|NCT02637557|147689764|SUPERIORITY||LS Mean Difference|-0.482||||0.0019|TWO_SIDED|95.0|-0.785|-0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.180|-0.785|0.0019
74068976|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|0.143||||0.1922|TWO_SIDED|95.0|-0.072|0.357||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.357|-0.072|0.1922
74068977|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|0.072||||0.5091|TWO_SIDED|95.0|-0.143|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.288|-0.143|0.5091
74068978|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|0.037||||0.7394|TWO_SIDED|95.0|-0.181|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.254|-0.181|0.7394
74068979|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|0.073||||0.5845|TWO_SIDED|95.0|-0.189|0.334||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.334|-0.189|0.5845
74068980|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.034||||0.7959|TWO_SIDED|95.0|-0.296|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.228|-0.296|0.7959
74068981|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.015||||0.9086|TWO_SIDED|95.0|-0.28|0.249||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.249|-0.280|0.9086
74068982|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.08||||0.5334|TWO_SIDED|95.0|-0.333|0.173||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.173|-0.333|0.5334
74068983|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.212||||0.102|TWO_SIDED|95.0|-0.466|0.042||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.042|-0.466|0.1020
74068984|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.357||||0.0066|TWO_SIDED|95.0|-0.613|-0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.100|-0.613|0.0066
74068985|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.127||||0.3586|TWO_SIDED|95.0|-0.399|0.145||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.145|-0.399|0.3586
74068986|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.348||||0.0128|TWO_SIDED|95.0|-0.621|-0.075||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.075|-0.621|0.0128
74068987|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.384||||0.0064|TWO_SIDED|95.0|-0.66|-0.109||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.109|-0.660|0.0064
74068988|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.076||||0.6124|TWO_SIDED|95.0|-0.369|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.218|-0.369|0.6124
74068989|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.223||||0.1365|TWO_SIDED|95.0|-0.518|0.071||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.071|-0.518|0.1365
74068990|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.355||||0.0193|TWO_SIDED|95.0|-0.652|-0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.058|-0.652|0.0193
74068991|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.037||||0.8046|TWO_SIDED|95.0|-0.333|0.258||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.258|-0.333|0.8046
74068992|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.319||||0.035|TWO_SIDED|95.0|-0.616|-0.023||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.023|-0.616|0.0350
74068993|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.392||||0.0105|TWO_SIDED|95.0|-0.691|-0.093||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.093|-0.691|0.0105
74068994|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.094||||0.5482|TWO_SIDED|95.0|-0.403|0.214||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.214|-0.403|0.5482
74068995|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.377||||0.017|TWO_SIDED|95.0|-0.687|-0.068||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.068|-0.687|0.0170
74068996|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.469||||0.0034|TWO_SIDED|95.0|-0.781|-0.157||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.157|-0.781|0.0034
74068997|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.093||||0.5346|TWO_SIDED|95.0|-0.388|0.202||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.202|-0.388|0.5346
74068998|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.336||||0.0262|TWO_SIDED|95.0|-0.632|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.040|-0.632|0.0262
74068999|NCT02637557|147689765|SUPERIORITY||LS Mean Difference|-0.545||||0.0004|TWO_SIDED|95.0|-0.843|-0.246||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.246|-0.843|0.0004
74069000|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|0.098||||0.3007|TWO_SIDED|95.0|-0.088|0.284||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.284|-0.088|0.3007
74069001|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|0.143||||0.1295|TWO_SIDED|95.0|-0.042|0.328||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.328|-0.042|0.1295
74069002|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.028||||0.7671|TWO_SIDED|95.0|-0.216|0.159||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.159|-0.216|0.7671
74069003|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|0.01||||0.9308|TWO_SIDED|95.0|-0.217|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.238|-0.217|0.9308
74069004|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|0.051||||0.6595|TWO_SIDED|95.0|-0.176|0.277||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.277|-0.176|0.6595
74069005|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.127||||0.2771|TWO_SIDED|95.0|-0.356|0.102||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.102|-0.356|0.2771
74069006|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.203||||0.0887|TWO_SIDED|95.0|-0.436|0.031||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.031|-0.436|0.0887
74069007|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.21||||0.0758|TWO_SIDED|95.0|-0.443|0.022||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.022|-0.443|0.0758
74069008|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.298||||0.0132|TWO_SIDED|95.0|-0.534|-0.063||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.063|-0.534|0.0132
74069009|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.086||||0.4903|TWO_SIDED|95.0|-0.332|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.160|-0.332|0.4903
74069010|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.068||||0.5824|TWO_SIDED|95.0|-0.313|0.176||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.176|-0.313|0.5824
74069011|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.215||||0.0885|TWO_SIDED|95.0|-0.463|0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.033|-0.463|0.0885
74069012|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.111||||0.3652|TWO_SIDED|95.0|-0.352|0.13||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.130|-0.352|0.3652
74069013|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.108||||0.3739|TWO_SIDED|95.0|-0.348|0.131||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.131|-0.348|0.3739
74069014|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.27||||0.0294|TWO_SIDED|95.0|-0.512|-0.027||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.027|-0.512|0.0294
74069015|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.102||||0.4236|TWO_SIDED|95.0|-0.351|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.148|-0.351|0.4236
74069016|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.105||||0.4071|TWO_SIDED|95.0|-0.353|0.144||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.144|-0.353|0.4071
74069017|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.259||||0.0434|TWO_SIDED|95.0|-0.51|-0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.008|-0.510|0.0434
74069018|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.103||||0.4172|TWO_SIDED|95.0|-0.354|0.147||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.147|-0.354|0.4172
74069019|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.071||||0.5759|TWO_SIDED|95.0|-0.321|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.179|-0.321|0.5759
74069020|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.285||||0.0271|TWO_SIDED|95.0|-0.538|-0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.033|-0.538|0.0271
74069021|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.14||||0.2804|TWO_SIDED|95.0|-0.395|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.115|-0.395|0.2804
74069022|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.218||||0.0913|TWO_SIDED|95.0|-0.472|0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.035|-0.472|0.0913
74069023|NCT02637557|147689766|SUPERIORITY||LS Mean Difference|-0.38||||0.0039|TWO_SIDED|95.0|-0.637|-0.123||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.123|-0.637|0.0039
74069024|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|0.128||||0.1902|TWO_SIDED|95.0|-0.064|0.319||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.319|-0.064|0.1902
74069025|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|0.1||||0.3021|TWO_SIDED|95.0|-0.091|0.292||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.292|-0.091|0.3021
74069026|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.028||||0.775|TWO_SIDED|95.0|-0.221|0.165||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.165|-0.221|0.7750
74069027|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|0.099||||0.4022|TWO_SIDED|95.0|-0.133|0.33||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.330|-0.133|0.4022
74069028|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|0.062||||0.5971|TWO_SIDED|95.0|-0.169|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.293|-0.169|0.5971
74069029|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.045||||0.7024|TWO_SIDED|95.0|-0.279|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.188|-0.279|0.7024
74069030|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.115||||0.3173|TWO_SIDED|95.0|-0.342|0.111||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.111|-0.342|0.3173
74069031|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.151||||0.1906|TWO_SIDED|95.0|-0.378|0.076||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.076|-0.378|0.1906
74069032|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.183||||0.1177|TWO_SIDED|95.0|-0.412|0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.046|-0.412|0.1177
74069033|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.05||||0.6936|TWO_SIDED|95.0|-0.297|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.198|-0.297|0.6936
74069034|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.096||||0.4466|TWO_SIDED|95.0|-0.343|0.152||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.152|-0.343|0.4466
74069035|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.155||||0.2225|TWO_SIDED|95.0|-0.405|0.095||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.095|-0.405|0.2225
74069036|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.052||||0.6764|TWO_SIDED|95.0|-0.297|0.193||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.193|-0.297|0.6764
74069037|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.061||||0.6243|TWO_SIDED|95.0|-0.306|0.184||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.184|-0.306|0.6243
74069038|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.156||||0.2151|TWO_SIDED|95.0|-0.403|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.091|-0.403|0.2151
74069039|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.096||||0.4611|TWO_SIDED|95.0|-0.351|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.160|-0.351|0.4611
74069040|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.139||||0.2849|TWO_SIDED|95.0|-0.394|0.116||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.116|-0.394|0.2849
74069041|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.228||||0.0833|TWO_SIDED|95.0|-0.485|0.03||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.030|-0.485|0.0833
74069042|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.017||||0.8955|TWO_SIDED|95.0|-0.277|0.242||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.242|-0.277|0.8955
74069043|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.052||||0.6916|TWO_SIDED|95.0|-0.312|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.207|-0.312|0.6916
74069044|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.159||||0.2345|TWO_SIDED|95.0|-0.421|0.103||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.103|-0.421|0.2345
74069045|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.043||||0.7466|TWO_SIDED|95.0|-0.304|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.218|-0.304|0.7466
74069046|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.176||||0.1843|TWO_SIDED|95.0|-0.437|0.084||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.084|-0.437|0.1843
74069047|NCT02637557|147689767|SUPERIORITY||LS Mean Difference|-0.267||||0.0471|TWO_SIDED|95.0|-0.531|-0.003||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.003|-0.531|0.0471
74069048|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|0.088||||0.3258|TWO_SIDED|95.0|-0.088|0.265||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.265|-0.088|0.3258
74069049|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|0.084||||0.3483|TWO_SIDED|95.0|-0.092|0.261||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.261|-0.092|0.3483
74069050|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|0.022||||0.8055|TWO_SIDED|95.0|-0.156|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.201|-0.156|0.8055
74069051|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|0.103||||0.3627|TWO_SIDED|95.0|-0.119|0.326||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.326|-0.119|0.3627
74069052|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|0.087||||0.4404|TWO_SIDED|95.0|-0.135|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.310|-0.135|0.4404
74069053|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|0.001||||0.9939|TWO_SIDED|95.0|-0.224|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.226|-0.224|0.9939
74069054|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.128||||0.2716|TWO_SIDED|95.0|-0.356|0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.100|-0.356|0.2716
74069055|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.116||||0.3175|TWO_SIDED|95.0|-0.345|0.112||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.112|-0.345|0.3175
74069056|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.252||||0.0325|TWO_SIDED|95.0|-0.483|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.021|-0.483|0.0325
74069057|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.169||||0.1769|TWO_SIDED|95.0|-0.415|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.077|-0.415|0.1769
74069058|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.188||||0.1343|TWO_SIDED|95.0|-0.434|0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.058|-0.434|0.1343
74069059|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.295||||0.0203|TWO_SIDED|95.0|-0.544|-0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.046|-0.544|0.0203
74069060|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.152||||0.2543|TWO_SIDED|95.0|-0.415|0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.110|-0.415|0.2543
74069061|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.142||||0.2892|TWO_SIDED|95.0|-0.405|0.121||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.121|-0.405|0.2892
74069062|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.306||||0.0243|TWO_SIDED|95.0|-0.571|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.040|-0.571|0.0243
74069063|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.059||||0.6471|TWO_SIDED|95.0|-0.312|0.194||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.194|-0.312|0.6471
74069064|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.106||||0.4123|TWO_SIDED|95.0|-0.359|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.148|-0.359|0.4123
74069065|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.278||||0.0338|TWO_SIDED|95.0|-0.534|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.021|-0.534|0.0338
74069066|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.095||||0.4841|TWO_SIDED|95.0|-0.362|0.172||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.172|-0.362|0.4841
74069067|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.152||||0.2627|TWO_SIDED|95.0|-0.419|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.115|-0.419|0.2627
74069068|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.311||||0.0241|TWO_SIDED|95.0|-0.581|-0.041||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.041|-0.581|0.0241
73883418|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.165|||<|0.0001|TWO_SIDED|95.0|2.234|4.095|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.095|2.234|<.0001
74069069|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.093||||0.4881|TWO_SIDED|95.0|-0.355|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.170|-0.355|0.4881
74069070|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.164||||0.2205|TWO_SIDED|95.0|-0.427|0.099||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.099|-0.427|0.2205
74069071|NCT02637557|147689768|SUPERIORITY||LS Mean Difference|-0.433||||0.0015|TWO_SIDED|95.0|-0.699|-0.168||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.168|-0.699|0.0015
74069072|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|0.043||||0.6653|TWO_SIDED|95.0|-0.152|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.238|-0.152|0.6653
74069073|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|0.15||||0.1327|TWO_SIDED|95.0|-0.046|0.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.345|-0.046|0.1327
74069074|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|0.043||||0.6697|TWO_SIDED|95.0|-0.155|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.241|-0.155|0.6697
74069075|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|0.021||||0.8598|TWO_SIDED|95.0|-0.21|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.251|-0.210|0.8598
74069076|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|0.113||||0.3354|TWO_SIDED|95.0|-0.118|0.344||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.344|-0.118|0.3354
74069077|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|0.055||||0.6429|TWO_SIDED|95.0|-0.179|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.289|-0.179|0.6429
74069078|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.101||||0.401|TWO_SIDED|95.0|-0.336|0.135||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.135|-0.336|0.4010
74069079|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.129||||0.2821|TWO_SIDED|95.0|-0.364|0.106||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.106|-0.364|0.2821
74069080|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.149||||0.2189|TWO_SIDED|95.0|-0.388|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.089|-0.388|0.2189
74069081|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.093||||0.4717|TWO_SIDED|95.0|-0.346|0.161||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.161|-0.346|0.4717
74069082|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.096||||0.4572|TWO_SIDED|95.0|-0.349|0.158||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.158|-0.349|0.4572
74069083|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.165||||0.2064|TWO_SIDED|95.0|-0.422|0.092||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.092|-0.422|0.2064
74069084|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.088||||0.4932|TWO_SIDED|95.0|-0.339|0.164||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.164|-0.339|0.4932
74069085|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.069||||0.5897|TWO_SIDED|95.0|-0.321|0.183||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.183|-0.321|0.5897
74069086|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.166||||0.2014|TWO_SIDED|95.0|-0.421|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.089|-0.421|0.2014
74069087|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.044||||0.7384|TWO_SIDED|95.0|-0.304|0.215||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.215|-0.304|0.7384
74069088|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.043||||0.7423|TWO_SIDED|95.0|-0.303|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.216|-0.303|0.7423
74069089|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.141||||0.2923|TWO_SIDED|95.0|-0.404|0.122||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.122|-0.404|0.2923
74069090|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.085||||0.5388|TWO_SIDED|95.0|-0.359|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.188|-0.359|0.5388
74069091|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|0.008||||0.9565|TWO_SIDED|95.0|-0.266|0.281||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.281|-0.266|0.9565
74069092|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.099||||0.4848|TWO_SIDED|95.0|-0.376|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.179|-0.376|0.4848
74069093|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.164||||0.2523|TWO_SIDED|95.0|-0.445|0.117||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.117|-0.445|0.2523
74069094|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.112||||0.4356|TWO_SIDED|95.0|-0.393|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.170|-0.393|0.4356
74069095|NCT02637557|147689769|SUPERIORITY||LS Mean Difference|-0.199||||0.1706|TWO_SIDED|95.0|-0.485|0.086||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.086|-0.485|0.1706
74069096|NCT02637557|147689770|SUPERIORITY||LS Mean Difference|-0.02||||0.7689|TWO_SIDED|95.0|-0.155|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.115|-0.155|0.7689
74069097|NCT02637557|147689770|SUPERIORITY||LS Mean Difference|0.034||||0.6287|TWO_SIDED|95.0|-0.103|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.170|-0.103|0.6287
74069098|NCT02637557|147689770|SUPERIORITY||LS Mean Difference|0.07||||0.3106|TWO_SIDED|95.0|-0.066|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.207|-0.066|0.3106
74069099|NCT02637557|147689771|SUPERIORITY||LS Mean Difference|0.0||||0.9961|TWO_SIDED|95.0|-0.1|0.101||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.101|-0.100|0.9961
74069100|NCT02637557|147689771|SUPERIORITY||LS Mean Difference|-0.008||||0.8829|TWO_SIDED|95.0|-0.109|0.094||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.094|-0.109|0.8829
74069101|NCT02637557|147689771|SUPERIORITY||LS Mean Difference|0.1||||0.0527|TWO_SIDED|95.0|-0.001|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.201|-0.001|0.0527
74069102|NCT04604184|147689795|OTHER||Risk Difference (RD)|-5.39||||0.3232|TWO_SIDED|95.0|-16.08|5.3|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||5.30|-16.08|0.3232
74069103|NCT04604184|147689796|OTHER||Risk Difference (RD)|-9.86||||0.1274|TWO_SIDED|95.0|-22.54|2.82|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||2.82|-22.54|0.1274
74069104|NCT04604184|147689797|OTHER||Risk Difference (RD)|2.66||||0.6828|TWO_SIDED|95.0|-10.11|15.43|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||15.43|-10.11|0.6828
74069105|NCT04604184|147689798|OTHER||Rate Ratio|0.67||||0.0445|TWO_SIDED|95.0|0.46|0.99|||Regression, Cox|Covariates are treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalization||||0.99|0.46|0.0445
74069106|NCT04604184|147689799|OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.35||0.5526|TWO_SIDED|95.0|-3.47|1.87|||ANCOVA|Fixed effects of treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalisation as covariates|Difference = covariate adjusted BI 764198 - covariate adjusted Placebo|||1.87|-3.47|0.5526
74069107|NCT04604184|147689800|OTHER||Risk Difference (RD)|5.32||||0.0995|TWO_SIDED|95.0|-1.01|11.65|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 15||11.65|-1.01|0.0995
74069108|NCT04604184|147689800|OTHER||Risk Difference (RD)|6.06||||0.1992|TWO_SIDED|95.0|-3.19|15.31|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 29||15.31|-3.19|0.1992
74069109|NCT04604184|147689800|OTHER||Risk Difference (RD)|8.93||||0.0709|TWO_SIDED|95.0|-0.76|18.62|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 60||18.62|-0.76|0.0709
74069110|NCT04604184|147689800|OTHER||Risk Difference (RD)|10.35||||0.0412|TWO_SIDED|95.0|0.41|20.28|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 90||20.28|0.41|0.0412
74069111|NCT01711021|147689808|SUPERIORITY||Least Square (LS) mean difference|-5.87|||<|0.001|TWO_SIDED|95.0|-6.76|-4.97|||Mixed Models Analysis|Mixed model repeated measure (MMRM) analysis for SKAMP total score in Double-Blind period||||-4.97|-6.76|< 0.001
74069112|NCT01711021|147689810|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
74069113|NCT03734237|147689815|EQUIVALENCE|Null Hypothesis: RR=1, Alternative hypothesis: RR not equal to 1|Risk Ratio (RR)|-26.7||||0.1412|TWO_SIDED|95.0|-73.7|7.6|||Chi-squared|||Relative vaccine effectiveness with the outcome laboratory confirmed influenza identified via surveillance and/or abstracted from clinical records.||7.6|-73.7|0.1412
74069114|NCT03734237|147689815|EQUIVALENCE|Null Hypothesis: RR=1, Alternative hypothesis: RR not equal to 1.|Risk Ratio (RR)|-13.1||||0.4552|TWO_SIDED|95.0|-56.4|18.2|||Chi-squared|||Relative vaccine effectiveness with the outcome laboratory confirmed influenza identified via surveillance and/or abstracted from clinical records.||18.2|-56.4|0.4552
74069115|NCT01844583|147689830|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.14|||||TWO_SIDED|90.0|0.97|1.35|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.35|0.97|
74069116|NCT01844583|147689831|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.08|1.45|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.45|1.08|
74069117|NCT01844583|147689832|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.07|1.53|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.53|1.07|
74069118|NCT01844583|147689835|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.03|||||TWO_SIDED|90.0|0.84|1.26|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.26|0.84|
74069119|NCT01844583|147689836|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.51|||||TWO_SIDED|90.0|0.41|0.62|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||0.62|0.41|
74069120|NCT01844583|147689837|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.53|||||TWO_SIDED|90.0|0.41|0.7|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||0.70|0.41|
74069121|NCT01625377|147689843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.34|||<|0.0001|TWO_SIDED|95.0|-21.34|-7.34|||ANCOVA|||||-7.34|-21.34|<0.0001
74069122|NCT03513497|147689856|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
74069123|NCT03513497|147689857|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
74069124|NCT03513497|147689858|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
74069125|NCT03513497|147689859|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
74069126|NCT01412541|147689862|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The evaluable sample size required for 90% power is 150 (50 Control plus 100 Test). This endpoint is not the sample-size driver of the study. Randomization of 476 subjects is expected to provide at least 405 evaluable subjects, after adjustment for up to 15% censoring) and approximately 99% power.||||||0.025|||||||Farrington and Manning|||"To assess if proportion of subjects with at least one safety event\* in the Test group is inferior or not inferior to that of Control group through 12-months Post index procedure (PPI) H0: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically inferior to that of the Control group.~H1: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically non-inferior to that of the Control group."||||0.025
74069127|NCT01412541|147689863|EQUIVALENCE|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test at α=0.05. The response variable in each subject will be the presence or absence of at least one efficacy event from the time following the index procedure through 12 months. The study evaluable sample size required for 90% power is approximately 405 subjects. After adjustment for 15% censoring through 12 months, the study size is 476.||||||0.05|||||||Chi-squared|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test.||"To assess whether the proportion of subjects with at least one efficacy event\* in the Test group is equal or not to that of Control group through 12-months post-index procedure.~H0: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is equal to that of the Test group.~H1: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is not equal to that of the Test group."||||0.05
74069128|NCT03294538|147689880|EQUIVALENCE|If the adjusted 90% confidence interval on the difference between proportions of participants considered Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range \[-0.20, +0.20\], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|0.7|||||TWO_SIDED|90.0|-5.8|7.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the primary endpoint was evaluated in the PP population.||7.2|-5.8|
74069129|NCT03294538|147689881|SUPERIORITY|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|19.9|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||<0.0001
74069130|NCT03294538|147689881|SUPERIORITY|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|20.2|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||<0.0001
74069131|NCT03294538|147689882|EQUIVALENCE|If the adjusted 90% confidence interval on the difference between proportions of participants considered Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range \[-0.20, +0.20\], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|-1.4|||||TWO_SIDED|90.0|-9.0|6.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the secondary endpoint was evaluated in the PP population.||6.2|-9.0|
74069132|NCT03294538|147689883|SUPERIORITY|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|4.9||||0.2897|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the secondary endpoint was evaluated in the mITT population.||||0.2897
74069133|NCT03294538|147689883|SUPERIORITY|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|3.9||||0.4949|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||0.4949
74069134|NCT02833415|147689893|OTHER|Differences of Least Squares Means|Differences of Least Squares Means|0.9398|STANDARD_ERROR_OF_MEAN|0.2941||0.0053|TWO_SIDED||||||Mixed Models Analysis|||Baseline to Followup||||0.0053
74069135|NCT02833415|147689893|OTHER|Differences of Least Squares Means|Differences of Least Squares Means|0.152|STANDARD_ERROR_OF_MEAN|0.2424||0.5394|TWO_SIDED||||||Mixed Models Analysis|||Baseline to Followup||||0.5394
74069136|NCT00449072|147689896|SUPERIORITY_OR_OTHER||Difference (LS Mean)|-0.45||||0.0096|TWO_SIDED|95.0|-0.78|-0.11|||ANCOVA|The treatment arm, age group (at Visit 1) and sex were fixed effects, and baseline growth velocity was a covariate in the ANCOVA model||||-0.11|-0.78|0.0096
74069137|NCT00449072|147689897|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.7341|TWO_SIDED|95.0|-0.83|0.58|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|||0.58|-0.83|0.7341
74069138|NCT00449072|147689898|SUPERIORITY_OR_OTHER||LS Mean Differerence|-0.15||||0.1963|TWO_SIDED|95.0|-0.37|0.08|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in nasal stuffiness||0.08|-0.37|0.1963
74069139|NCT00449072|147689898|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.7193|TWO_SIDED|95.0|-0.24|0.17|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Discharge||0.17|-0.24|0.7193
74069140|NCT00449072|147689898|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.402|TWO_SIDED|95.0|-0.12|0.29|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Sneezing||0.29|-0.12|0.4020
74069141|NCT00449072|147689898|SUPERIORITY_OR_OTHER||LS mean Difference|-0.02||||0.8854|TWO_SIDED|95.0|-0.23|0.2|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Itching||0.20|-0.23|0.8854
74069142|NCT00449072|147689899|SUPERIORITY_OR_OTHER|||||||0.0951||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120||||0.0951
74069143|NCT00449072|147689899|SUPERIORITY_OR_OTHER|||||||0.1247||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 240||||0.1247
74069144|NCT00449072|147689899|SUPERIORITY_OR_OTHER|||||||0.0207||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 360||||0.0207
74069145|NCT00449072|147689900|SUPERIORITY_OR_OTHER|||||||0.2445||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120||||0.2445
74069146|NCT00449072|147689900|SUPERIORITY_OR_OTHER|||||||0.4488||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 240||||0.4488
74069147|NCT00449072|147689900|SUPERIORITY_OR_OTHER|||||||0.0142||95.0||||The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.|Mixed model for repeated measures|||Statistical Analysis for Day 360||||0.0142
74069148|NCT01769378|147689906|SUPERIORITY_OR_OTHER||LS Squares Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.57|-0.97|||Mixed Models Analysis|||||-0.97|-1.57|<0.001
74069149|NCT01769378|147689907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.37|||<|0.001|TWO_SIDED|95.0|3.82|33.84|||Regression, Logistic|Sequential gatekeeping strategy was used to adjust for multiplicity.||\<7.0% HbA1c||33.84|3.82|<0.001
74069150|NCT01769378|147689907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.45|||<|0.001|TWO_SIDED|95.0|3.71|35.34|||Regression, Logistic|||≤6.5% HbA1c||35.34|3.71|<0.001
73883419|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.205|||<|0.0001|TWO_SIDED|95.0|2.318|4.092|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.092|2.318|<.0001
74069151|NCT01769378|147689908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-33.54|STANDARD_ERROR_OF_MEAN|6.6|<|0.001|TWO_SIDED|95.0|-46.55|-20.53|||ANCOVA|Sequential gatekeeping strategy was used to adjust for multiplicity.||||-20.53|-46.55|<0.001
74069152|NCT01769378|147689909|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.43||0.12|TWO_SIDED|95.0|-1.53|0.18|||Mixed Models Analysis|Sequential gatekeeping strategy was used to adjust for multiplicity.||||0.18|-1.53|0.120
74069153|NCT01769378|147689910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.161|TWO_SIDED|95.0|-0.54|0.09||No adjustment for multiplicity|Mixed Models Analysis|||||0.09|-0.54|0.161
74069154|NCT01769378|147689911|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-28.95|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-38.49|-19.4|||Mixed Models Analysis|||||-19.40|-38.49|<0.001
74069155|NCT01798485|147689933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.3293|TWO_SIDED|95.0|0.899|1.372|||Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||Primary study hypothesis was tested at a 2-sided, 0.05 significance level using a stratified log-rank test.||1.372|0.899|0.3293
74069156|NCT01798485|147689933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111|||||TWO_SIDED|99.5|0.821|1.503||||||"Futility analysis for the first Interim Analysis which had a database cutoff of 19 October 2015. For the first interim analysis, if the lower limit of the 2-sided 99.5% confidence interval (CI) for the Hazard Ratio was greater than 0.75, then the study could be stopped for futility, based on Data Monitoring Committee recommendation.~Hazard ratio and 99.5% CI were calculated using the stratified Cox Proportional Hazards model (strata: screening LDH, screening ECOG and geographic region)."||1.503|0.821|
74069157|NCT01798485|147689934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.161||||0.118|TWO_SIDED|95.0|0.961|1.403||Significance level of 0.05.|Log Rank|Stratified log-rank test with stratification variables, ECOG, screening total LDH levels, and geographic region, used to compare the treatment groups.||||1.403|0.961|0.1180
74069158|NCT01798485|147689935|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232||||0.2506|TWO_SIDED|95.0|0.865|1.754||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).||||1.754|0.865|0.2506
74069159|NCT01798485|147689936|SUPERIORITY_OR_OTHER|||||||0.448|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||||||0.448
74069160|NCT01798485|147689937|SUPERIORITY_OR_OTHER|||||||0.339|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||\>= 6 weeks||||0.339
74069161|NCT01798485|147689937|SUPERIORITY_OR_OTHER|||||||0.817|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||\>= 12 weeks||||0.817
74069162|NCT01798485|147689938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.344||||0.0111|TWO_SIDED|95.0|1.207|4.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||||4.551|1.207|0.0111
74069163|NCT01798485|147689939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.112||||0.5191|TWO_SIDED|95.0|0.797|1.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).||||1.551|0.797|0.5191
74069164|NCT01798485|147689942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.233||||0.1343|TWO_SIDED|95.0|0.937|1.621||Significance level of 0.05.|Log Rank|Stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||||1.621|0.937|0.1343
74069165|NCT01798485|147689943|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||||||0.250
74069166|NCT00891878|147690057|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
74069167|NCT00891878|147690058|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
74069168|NCT01199601|147690067|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.12|STANDARD_DEVIATION|0.05|<|0.05|TWO_SIDED|95.0|1.02|1.23|||Regression, Linear|Information provided for crude analysis results; adjustment for significant baseline differences between groups did not change results substantially.||Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.||1.23|1.02|<0.05
74069169|NCT01199601|147690068|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.1|STANDARD_DEVIATION|0.05|<|0.05|TWO_SIDED|95.0|1.02|1.18|||Regression, Linear|Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.||||1.18|1.02|<0.05
74069170|NCT01199601|147690069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|95.0|1.01|1.25|||Regression, Logistic|The crude analysis result is provided as the odds ratio did not change substantially when adjusted for possible confounders.||||1.25|1.01|0.05
74069171|NCT01688037|147690100|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.2966|TWO_SIDED|95.0|-2.3|0.7|||ANCOVA|||||0.7|-2.3|0.2966
74069172|NCT01688037|147690101|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.743|TWO_SIDED|95.0|-0.3|0.4|||ANOVA|||||0.4|-0.3|0.743
74069173|NCT01688037|147690102|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1151|TWO_SIDED|95.0|-0.7|0.1|||ANOVA|||||0.1|-0.7|0.1151
74069174|NCT01688037|147690102|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0277|TWO_SIDED|95.0|-0.8|0.0|||ANOVA|||||0.0|-0.8|0.0277
73888331|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|147.0||||0.0007|TWO_SIDED|95.0|63.0|231.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||231.1|63.0|0.0007
74069175|NCT02100956|147690103|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Null hypothesis was that there was no difference in VAS pain scale scores after intrathecal study drug injection between oxytocin and placebo. To account for repeated measures across time and drug conditions, VAS apin scale scores were analyzed using a linear mixed-effects model with random intercepts at the level of participant. Each outcome was regressed on fixed-effects for order of study day, study drug, time after injection, and drug x time interaction.||||<0.05
74069176|NCT02473991|147690114|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during second trimesters may be correlated with birth weight at term.||||<0.01
74069177|NCT02473991|147690115|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during third trimesters may be correlated with birth weight at term.||||<0.01
74069178|NCT03065283|147690125|EQUIVALENCE|p\< or = 0.05|Mean Difference (Final Values)|0.09||||0.05|TWO_SIDED|95.0|-0.38|0.57|||t-test, 2 sided|||A paired t-test was used for intragroup analysis, and an independent Student's t-test was used for intergroup analysis. Data are represented in mean between-group difference with a 95% CI, and analysis was by intention to treat.||0.57|-0.38|0.05
74069179|NCT00095199|147690129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.756|TWO_SIDED|95.0|0.87|1.21||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.21|0.87|0.756
74069180|NCT00095199|147690129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.391|TWO_SIDED|95.0|0.73|1.13||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.13|0.73|0.391
74069181|NCT00095199|147690130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.864|TWO_SIDED|95.0|0.86|1.2||The 2-sided unstratified log-rank test was employed at the 5% significance level|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.20|0.86|0.864
74069182|NCT00095199|147690130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.307|TWO_SIDED|95.0|0.9|1.41||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.41|0.90|0.307
74069183|NCT00095199|147690131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.2|TWO_SIDED|95.0|0.78|3.26||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||3.26|0.78|0.200
74069184|NCT00095199|147690131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.683|TWO_SIDED|95.0|0.52|2.74||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.74|0.52|0.683
74069185|NCT00095199|147690132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.31|TWO_SIDED|95.0|0.86|1.62||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.62|0.86|0.310
74069186|NCT00095199|147690132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1|TWO_SIDED|95.0|0.93|2.4||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.40|0.93|0.100
74069187|NCT00095199|147690133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.091|TWO_SIDED|95.0|0.46|1.06||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.06|0.46|0.091
74069188|NCT00095199|147690133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.361|TWO_SIDED|95.0|0.72|2.5||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.50|0.72|0.361
74069189|NCT00095199|147690134|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.472|TWO_SIDED|95.0|0.77|1.74||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.74|0.77|0.472
74069190|NCT00095199|147690134|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.272|TWO_SIDED|95.0|0.42|1.27||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.27|0.42|0.272
73888332|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|148.1||||0.0007|TWO_SIDED|95.0|63.9|232.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||232.4|63.9|0.0007
74069191|NCT00095199|147690135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58||||0.236|TWO_SIDED|95.0|0.74|3.36||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||3.36|0.74|0.236
74069192|NCT00095199|147690135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.887|TWO_SIDED|95.0|0.42|2.18||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.18|0.42|0.887
74069193|NCT01767597|147690146|SUPERIORITY_OR_OTHER|||||||0.5||||||No p-value adjustments for multiple comparisons were required. Significance was determined using a p-value \<0.05.|Chi-squared|||Power calculations were performed to detect \>15% difference in immediate linkage-to-care and vaccination. We hypothesized from discussions with an expert panel that \~30% of participants would have appropriate care with standard HBV serology. Assuming type 1 error=0.05 and power=80%, 152 participants per arm would be needed. As \~40% of the population would be nonimmunized or HBsAg-positive from previous data, a minimum 375 participants per arm would be required.||||0.5
74069194|NCT02232074|147690148|SUPERIORITY||Odds Ratio (OR)|0.82||||0.77|TWO_SIDED|95.0|0.21|3.14||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||Compared to the control group, the Breast cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).||3.14|0.21|0.77
74069195|NCT02232074|147690149|SUPERIORITY||Odds Ratio (OR)|4.0||||0.26|TWO_SIDED|95.0|0.35|45.4||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||Compared to the control group, the Lung cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).||45.4|0.35|0.26
74069196|NCT02232074|147690150|SUPERIORITY||Median Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.42||0.53|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 3 months post-enrollment||||0.53
74069197|NCT02232074|147690151|SUPERIORITY||Median Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|1.62||0.43|TWO_SIDED|||||Adjusting for baseline Distress Thermometer scores.|Regression, Linear|||Compared to the control group, the LUNG cancer INTERVENTION group will have less distress at 3 months post-enrollment||||0.43
74069198|NCT02232074|147690152|SUPERIORITY||Median Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.18|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 6 months post-enrollment||||0.18
74069199|NCT02232074|147690153|SUPERIORITY||Median Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|1.29||0.33|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Lung cancer INTERVENTION group will have less distress at 6 months post-enrollment||||0.33
74069200|NCT02232074|147690154|SUPERIORITY||Median Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.07||0.68|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.68
74069201|NCT02232074|147690155|SUPERIORITY||Median Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.26|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.26
74069202|NCT02232074|147690156|SUPERIORITY||Median Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|1.43||0.62|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||Compared to the control group, the Breast cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment||||0.62
74069203|NCT02232074|147690157|SUPERIORITY||Median Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.91||0.69|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||Compared to the control group, the Lung cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment||||0.69
74069204|NCT02232074|147690158|SUPERIORITY||Median Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.59||0.58|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the breast cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.||||0.58
74069205|NCT02232074|147690159|SUPERIORITY||Median Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|2.21||0.09|TWO_SIDED||||||Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the lung cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.||||0.09
74069206|NCT02232074|147690160|SUPERIORITY||Odds Ratio (OR)|0.85||||0.79|TWO_SIDED|95.0|0.28|2.79||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will receive quality care (i.e. receipt of radiation within one year of diagnosis).||2.79|0.28|0.79
74069207|NCT02232074|147690161|SUPERIORITY||Median Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.5||0.71|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will have less distress at 12 months post-enrollment.||||0.71
74069208|NCT02232074|147690162|SUPERIORITY||Median Difference (Final Values)|-1.45|STANDARD_DEVIATION|2.71||0.61|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Lung cancer INTERVENTION group will have less distress at 12 months post-enrollment||||0.61
74069209|NCT02232074|147690163|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.08||0.46|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.46
74069210|NCT02232074|147690164|SUPERIORITY||Median Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.2||0.89|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.89
74069211|NCT02232074|147690165|SUPERIORITY||Mean Difference (Final Values)|2.38|STANDARD_DEVIATION|1.66||0.16|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.16
74069212|NCT02232074|147690166|SUPERIORITY||Mean Difference (Final Values)|-4.83|STANDARD_DEVIATION|2.93||0.16|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.16
74069213|NCT02232074|147690167|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_DEVIATION|0.75||0.13|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.13
74069214|NCT02232074|147690168|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_DEVIATION|3.7||0.8|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.80
74069215|NCT02637076|147690203|OTHER|||||||0.31|||||||repeated measures ANOVA|F(2,36)=1.26||||||0.31
74069216|NCT02637076|147690208|OTHER|||||||0.748|||||||repeated measures ANOVA|||||||0.748
74069217|NCT02398188|147690278|SUPERIORITY|||||||0.397|||||||Cochran-Mantel-Haenszel|||||||0.397
74069218|NCT02398188|147690279|SUPERIORITY|||||||0.379|||||||Cochran-Mantel-Haenszel|||||||0.379
74069219|NCT00782509|147690281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.116|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.185|0.116|<0.0001
74069220|NCT00782509|147690281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.11|0.177|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.177|0.110|<0.0001
74069221|NCT00782509|147690282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.019||0.0116||95.0|0.011|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.084|0.011|0.0116
74069222|NCT00782509|147690282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.019||0.0095||95.0|0.012|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.085|0.012|0.0095
74069223|NCT00782509|147690283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.057|0.162|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.162|0.057|<0.0001
74069224|NCT00782509|147690283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.027||0.0011||95.0|0.036|0.143|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.143|0.036|0.0011
74069225|NCT00782509|147690284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.131|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.131|<0.0001
74069226|NCT00782509|147690284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.138|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.204|0.138|<0.0001
74069227|NCT00782509|147690285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.13|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.130|<0.0001
74069228|NCT00782509|147690285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.119|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.186|0.119|<0.0001
74069229|NCT00782509|147690286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.135|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.135|<0.0001
74069230|NCT00782509|147690286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.127|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.195|0.127|<0.0001
74069231|NCT00782509|147690287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.131|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.200|0.131|<0.0001
74069232|NCT00782509|147690287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.102|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.171|0.102|<0.0001
74069233|NCT00782509|147690288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.127|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.196|0.127|<0.0001
74069234|NCT00782509|147690288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.123|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.123|<0.0001
74069235|NCT00782509|147690289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.018||0.0043||95.0|0.017|0.089|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.089|0.017|0.0043
74069236|NCT00782509|147690289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.018||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.101|0.028|0.0005
74069237|NCT00782509|147690290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.037|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.110|0.037|<0.0001
74069238|NCT00782509|147690290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.049|0.121|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.121|0.049|<0.0001
74069239|NCT00782509|147690291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.032|0.0002
74069240|NCT00782509|147690291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.019||0.0186||95.0|0.007|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.081|0.007|0.0186
74069241|NCT00782509|147690292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.032|0.0003
74069242|NCT00782509|147690292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.019||0.002||95.0|0.021|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.095|0.021|0.0020
74069243|NCT00782509|147690293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.019||0.0024||95.0|0.02|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.095|0.020|0.0024
74069244|NCT00782509|147690293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.019||0.1614||95.0|-0.011|0.064|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.064|-0.011|0.1614
74069245|NCT00782509|147690294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0012||95.0|0.025|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.099|0.025|0.0012
74069246|NCT00782509|147690294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.034|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.109|0.034|0.0002
74069247|NCT00782509|147690295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.019||0.0004||95.0|0.031|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.031|0.0004
74069248|NCT00782509|147690295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.033|0.108|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.108|0.033|0.0002
74069249|NCT00782509|147690296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.132|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.132|<0.0001
73888333|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|109.6||||0.011|TWO_SIDED|95.0|25.5|193.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||193.6|25.5|0.0110
74069250|NCT00782509|147690296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.142|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.142|<0.0001
74069251|NCT00782509|147690297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.119|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.190|0.119|<0.0001
74069252|NCT00782509|147690297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.111|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.182|0.111|<0.0001
74069253|NCT00782509|147690298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.136|<0.0001
74069254|NCT00782509|147690298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.13|0.202|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.202|0.130|<0.0001
74069255|NCT00782509|147690299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.108|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.180|0.108|<0.0001
74069256|NCT00782509|147690299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.094|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.166|0.094|<0.0001
74069257|NCT00782509|147690300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.201|0.128|<0.0001
74069258|NCT00782509|147690300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.098|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.171|0.098|<0.0001
74069259|NCT00782509|147690301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.118|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.192|0.118|<0.0001
74069260|NCT00782509|147690301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.12|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.194|0.120|<0.0001
74069261|NCT00782509|147690302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.263|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.399|0.263|<0.0001
74069262|NCT00782509|147690302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.265|0.4|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.400|0.265|<0.0001
74069263|NCT00782509|147690303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.174|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.174|<0.0001
74069264|NCT00782509|147690303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.159|0.294|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.294|0.159|<0.0001
74069265|NCT00782509|147690304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.195|0.332|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.332|0.195|<0.0001
74069266|NCT00782509|147690304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.246|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.178|0.315|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.315|0.178|<0.0001
74069267|NCT00782509|147690305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.17|0.308|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.308|0.170|<0.0001
74069268|NCT00782509|147690305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.176|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.314|0.176|<0.0001
74069269|NCT00782509|147690306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.171|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.311|0.171|<0.0001
74069270|NCT00782509|147690306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.15|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.289|0.150|<0.0001
74069271|NCT00782509|147690307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.147|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.288|0.147|<0.0001
74069272|NCT00782509|147690307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.148|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.288|0.148|<0.0001
74069273|NCT00782509|147690308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.037||0.104||95.0|-0.012|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|-0.012|0.1040
74069274|NCT00782509|147690308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.036||0.0172||95.0|0.015|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.158|0.015|0.0172
74069275|NCT00782509|147690309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.037||0.0106||95.0|0.022|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.166|0.022|0.0106
74069276|NCT00782509|147690309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.046|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.190|0.046|0.0013
74069277|NCT00782509|147690310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.037||0.3821||95.0|-0.04|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|-0.040|0.3821
74069278|NCT00782509|147690310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.037||0.1917||95.0|-0.024|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.120|-0.024|0.1917
74069279|NCT00782509|147690311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.037||0.1808||95.0|-0.023|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|-0.023|0.1808
74069280|NCT00782509|147690311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.037||0.37||95.0|-0.039|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.106|-0.039|0.3700
74069281|NCT00782509|147690312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.037||0.2312||95.0|-0.029|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.118|-0.029|0.2312
74069282|NCT00782509|147690312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.037||0.0596||95.0|-0.003|0.144|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.144|-0.003|0.0596
74069283|NCT00782509|147690313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.037||0.311||95.0|-0.036|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.111|-0.036|0.3110
74069284|NCT00782509|147690313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.038||0.9426||95.0|-0.076|0.071|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.071|-0.076|0.9426
74069285|NCT00782509|147690314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.038||0.268||95.0|-0.032|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.115|-0.032|0.2680
74069286|NCT00782509|147690314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.038||0.0662||95.0|-0.005|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.005|0.0662
74069287|NCT00782509|147690315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.038||0.2249||95.0|-0.028|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.120|-0.028|0.2249
74069288|NCT00782509|147690315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.038||0.0994||95.0|-0.012|0.136|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.136|-0.012|0.0994
74069289|NCT00782509|147690316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.332|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.261|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.403|0.261|<0.0001
74069290|NCT00782509|147690316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.263|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.403|0.263|<0.0001
74069291|NCT00782509|147690317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.153|0.296|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.296|0.153|<0.0001
74069292|NCT00782509|147690317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.139|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.281|0.139|<0.0001
74069293|NCT00782509|147690318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.196|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.340|0.196|<0.0001
74069294|NCT00782509|147690318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.179|0.323|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.323|0.179|<0.0001
74069295|NCT00782509|147690319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.154|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.298|0.154|<0.0001
74069296|NCT00782509|147690319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.137|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.281|0.137|<0.0001
74069297|NCT00782509|147690320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.153|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.153|<0.0001
74069298|NCT00782509|147690320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.133|0.279|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.279|0.133|<0.0001
74069299|NCT00782509|147690321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.133|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.280|0.133|<0.0001
74069300|NCT00782509|147690321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.138|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.285|0.138|<0.0001
74069301|NCT00782509|147690322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.047||0.0028||95.0|0.049|0.235|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.235|0.049|0.0028
74069302|NCT00782509|147690322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.048||0.0013||95.0|0.061|0.25|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.250|0.061|0.0013
74069303|NCT00782509|147690323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.36|STANDARD_ERROR_OF_MEAN|4.959||0.0072|TWO_SIDED|95.0|3.622|23.099|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||23.099|3.622|0.0072
74069304|NCT00782509|147690323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.934|STANDARD_ERROR_OF_MEAN|4.894|<|0.0001|TWO_SIDED|95.0|11.323|30.545|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||30.545|11.323|<0.0001
74069305|NCT00782509|147690324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.456|STANDARD_ERROR_OF_MEAN|5.201||0.0169|TWO_SIDED|95.0|2.242|22.67|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||22.670|2.242|0.0169
74069306|NCT00782509|147690324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.653|STANDARD_ERROR_OF_MEAN|5.132|<|0.0001|TWO_SIDED|95.0|10.574|30.731|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||30.731|10.574|<0.0001
74069307|NCT00782509|147690325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.416|STANDARD_ERROR_OF_MEAN|0.127||0.0011|TWO_SIDED|95.0|-0.665|-0.167|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.167|-0.665|0.0011
74069308|NCT00782509|147690325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.513|STANDARD_ERROR_OF_MEAN|0.125|<|0.0001|TWO_SIDED|95.0|-0.76|-0.267|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.267|-0.760|<0.0001
74069309|NCT00782509|147690326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.157||0.0077|TWO_SIDED|95.0|-0.729|-0.111|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.111|-0.729|0.0077
74069310|NCT00782509|147690326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.155|<|0.0001||95.0|-1.065|-0.456|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.456|-1.065|<0.0001
74069311|NCT00782509|147690327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.837|STANDARD_ERROR_OF_MEAN|0.252||0.001|TWO_SIDED|95.0|-1.333|-0.342|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.342|-1.333|0.0010
74069312|NCT00782509|147690327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.278|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|-1.767|-0.789|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.789|-1.767|<0.0001
74069313|NCT00782509|147690328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0122||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0122
74069314|NCT00782509|147690328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0008||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0008
74069315|NCT00782509|147690329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0028||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0028
74069316|NCT00782509|147690329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0169||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.0|-0.5|0.0169
74069317|NCT00782509|147690330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.018||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.0|-0.5|0.0180
74069318|NCT00782509|147690330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0015||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0015
74069319|NCT00782509|147690331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1313||95.0|-0.4|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||0.0|-0.4|0.1313
74069320|NCT00782509|147690331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0089||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0089
74069321|NCT00782509|147690332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.993|STANDARD_ERROR_OF_MEAN|0.187||0.9853|TWO_SIDED|95.0|0.687|1.436|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.436|0.687|0.9853
74069322|NCT00782509|147690332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|STANDARD_ERROR_OF_MEAN|0.222||0.2344|TWO_SIDED|95.0|0.873|1.763|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.763|0.873|0.2344
74069323|NCT00782509|147690333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.438||0.9035|TWO_SIDED|95.0|0.463|2.38|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||2.380|0.463|0.9035
74069324|NCT00782509|147690333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958|STANDARD_ERROR_OF_MEAN|0.408||0.9304|TWO_SIDED|95.0|0.415|2.209|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||2.209|0.415|0.9304
74069325|NCT00782509|147690334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|STANDARD_ERROR_OF_MEAN|0.233||0.669|TWO_SIDED|95.0|0.717|1.657|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.657|0.717|0.6690
74069326|NCT00782509|147690334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.344|STANDARD_ERROR_OF_MEAN|0.273||0.1437|TWO_SIDED|95.0|0.902|2.002|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||2.002|0.902|0.1437
74069327|NCT00782509|147690335|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.188|STANDARD_ERROR_OF_MEAN|0.2251||0.3637|TWO_SIDED|95.0|0.8188|1.7234|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.7234|0.8188|0.3637
74069328|NCT00782509|147690335|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2822|STANDARD_ERROR_OF_MEAN|0.2403||0.1853|TWO_SIDED|95.0|0.8874|1.8527|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.8527|0.8874|0.1853
74069329|NCT00782509|147690336|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0314|STANDARD_ERROR_OF_MEAN|0.4664||0.9455|TWO_SIDED|95.0|0.4244|2.5063|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||2.5063|0.4244|0.9455
74069330|NCT00782509|147690336|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1273|STANDARD_ERROR_OF_MEAN|0.5028||0.7883|TWO_SIDED|95.0|0.4696|2.7064|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.7064|0.4696|0.7883
74069331|NCT00782509|147690337|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2846|STANDARD_ERROR_OF_MEAN|0.2803||0.2514|TWO_SIDED|95.0|0.837|1.9717|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.9717|0.8370|0.2514
74069332|NCT00782509|147690337|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.3373|STANDARD_ERROR_OF_MEAN|0.2901||0.1807|TWO_SIDED|95.0|0.8735|2.0474|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.0474|0.8735|0.1807
74069333|NCT00220701|147690368|SUPERIORITY_OR_OTHER||F statistics|2.82||||0.1|TWO_SIDED||||||Repeated Measures ANOVA|||||||0.10
74069334|NCT01176448|147690375|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With 12 scars (or pairs to compare), our power calculation had a 95 percent probability that the study will detect a treatment difference at a two-sided 0.05 percent significance level, if a significant difference between treatments is 1.5 units (based on a 0-4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units.||||||0.77||95.0||||Appropriately powered, this study failed to reject the null hypothesis that fraxel achieves a similar cosmetic result at 3 months when compared to dermabrasion.|Wilcoxon (Mann-Whitney)|||efficacy outcomes analyzed by 3 surgeons blinded to the treatment and scars evaluated by halves comparing pre-treatment photos to 3-month photos and given a score on the quartile scale described in table 1. The ordinal rater scores of each evaluator were then averaged, and Wilcoxon Signed Ranks performed on the group's scores. (table 5) There were 4 Fraxel winners, 4 Dermabrasion winners, and 4 ties. There was a p value of 0.77 indicating no significant difference between the categories||||.77
74069335|NCT00755326|147690376|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
74069336|NCT04041570|147690392|OTHER|t-tests were only employed to determine which individuals were responders. Response rates with 95% Clopper-Pearson confidence intervals were reported within group.||||||0.05||||||The p-value was not adjusted for multiple comparisons and was only used to assess whether participants had a positive response or not.|t-test, 1 sided|This test was only used to determine whether participants were positive responders or not.||Statistical testing was performed within group and not between groups. Positivity for an individual was determined if there was a significant (p-value\<0.05) increase (one-sided test) in the ELISA titers at week 4 when compared to those at baseline. For each participant a t-test was performed to compare the triplicate baseline titers to their triplicate week 4 titers. The proportion of positive responses and associated Clopper-Pearson 95% was calculated within group.|For each participant, a positive response was defined as a significant increase in ELISA titer post vaccination (Week 4) from baseline (Week 0). Within each participant, a t-test is performed to compare the triplicate readings (replicates 1-3) post vaccination versus the triplicate readings at baseline. A participant is defined as a positive responder if one-sided t-test has p-value \< 0.05. The proportion of responders and associated 95% Clopper-Pearson Confidence Intervals were calculated.|||0.05
74069337|NCT03532009|147690405|SUPERIORITY|||||||0.426|||||||F-test|||The p-value was obtained by pooling the p-values from Chi-square tests performed on individual data sets using the F-distribution and reflects a global test of no difference in distribution of patients in the respective categories between SZC and placebo groups. The null hypothesis was that there is no difference between SZC and placebo in the distribution of percentage of patients in the 4 RAASi treatment categories. The hypothesis was tested at a significance level of 5%.||||0.426
74069338|NCT01288859|147690416|NON_INFERIORITY_OR_EQUIVALENCE|The results from LC-MS/MS analysis of parent polyphenols were analyzed and expressed as the absolute changes from the baseline to reduce possible effects of inter-subject fasting variability|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.1||0.02|TWO_SIDED|95.0|||||ANOVA|||||||0.02
74069339|NCT01288859|147690417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.01||0.01|TWO_SIDED|95.0|||||ANOVA|||Statistical analysis was performed using the statistical package SPSS for Windows (version15). By the analysis of variance (ANOVA) for repeated measures the subjective time curves for all measured compounds were compared and tested for the effect of treatment and of time as factors. For all tests, following a significant main effect in the ANOVA, individual means were compared using the Bonferroni test (p \< 0.05). Results were considered significant at p \< 0.05.||||0.01
74069340|NCT01288859|147690418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.01||0.04|TWO_SIDED|95.0|||||ANOVA|||||||0.04
74069341|NCT03588390|147690420|OTHER||Slope|0.696|STANDARD_ERROR_OF_MEAN|0.0971|||TWO_SIDED|95.0|0.5006|0.8914|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||0.8914|0.5006|
74069342|NCT03588390|147690420|OTHER||Slope|0.9244|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|0.6764|1.1724|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||1.1724|0.6764|
74069343|NCT03588390|147690421|OTHER||Slope|0.6533|STANDARD_ERROR_OF_MEAN|0.0982|||TWO_SIDED|95.0|0.4556|0.851|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||0.8510|0.4556|
74069344|NCT03588390|147690421|OTHER||Slope|0.8586|STANDARD_ERROR_OF_MEAN|0.1307|||TWO_SIDED|95.0|0.5929|1.1242|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||1.1242|0.5929|
74069345|NCT01006707|147690423|SUPERIORITY_OR_OTHER|||||||0.042|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.042
74069346|NCT01006707|147690424|SUPERIORITY_OR_OTHER|||||||0.322|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.322
74069347|NCT01006707|147690425|SUPERIORITY_OR_OTHER|||||||0.261|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.261
74069348|NCT02750306|147690426|SUPERIORITY||Difference in Least Squares Means|28.2||||0.00128|TWO_SIDED|95.0|11.1|45.2|||ANCOVA|||||45.2|11.1|0.00128
74069349|NCT02750306|147690429|SUPERIORITY||Difference in Least Squares Means|-15.7||||0.01354|TWO_SIDED|95.0|-28.1|-3.3|||ANCOVA|||||-3.3|-28.1|0.01354
74069350|NCT05034731|147690442|NON_INFERIORITY|Non-inferiority analyses were based on paired t-tests looking at the differences in speech scores calculated using the investigational speech scores minus the control speech scores. The primary efficacy analyses tested the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quite (remote fitting - in-office fitting) are less than or equal to -10 percentile points.|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
74069351|NCT05034731|147690443|NON_INFERIORITY|Non-inferiority analyses were based on paired t-tests looking at the differences in speech scores calculated using the investigational speech scores minus the control speech scores. The primary efficacy analyses tested the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quite (remote fitting - in-office fitting) are less than or equal to -10 percentile points.|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
74069352|NCT00283686|147690445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.52|TWO_SIDED|95.0|-0.8|5.0||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Test for differences between treatment groups over time.||||5.0|-0.8|0.52
74069353|NCT00283686|147690445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.006|TWO_SIDED|95.0|-1.6|-0.2||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Testing differences between blood pressure groups over time||||-0.2|-1.6|0.006
74069354|NCT00283686|147690446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.52|TWO_SIDED|95.0|-0.6|0.3||adjusting for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences in treatment over time (differences in slopes over time).||||0.3|-0.6|0.52
74069355|NCT00283686|147690446|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.55|TWO_SIDED|95.0|-0.3|0.6||adjusted for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences between groups over time (differences in slopes over time)||||0.6|-0.3|0.55
74069356|NCT00283686|147690447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.57|TWO_SIDED|95.0|-3.3|1.9|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||1.9|-3.3|0.57
74069357|NCT00283686|147690447|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|||<|0.0001|TWO_SIDED|95.0|-8.5|-3.4|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||-3.4|-8.5|<0.0001
74069358|NCT00283686|147690448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.18|TWO_SIDED|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.6|-3.1|0.18
74069359|NCT00283686|147690448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.19|TWO_SIDED|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.6|-3.1|0.19
74069360|NCT00283686|147690449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.088||||0.58|TWO_SIDED|95.0|-0.4|0.22|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing the annual change over time between ACE/ARB and ACE alone|||0.22|-0.40|0.58
74069361|NCT00283686|147690449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.0002|TWO_SIDED|95.0|-0.91|-0.29|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing annual change in LVMI between Low Blood Pressure and Standard Blood Pressure groups|||-0.29|-0.91|0.0002
74069362|NCT00283686|147690450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.97||||0.29|TWO_SIDED|95.0|-2.55|8.5|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change in mL/min/1.73 m\^2 for ACE+ARB compared to ACE alone|||8.50|-2.55|0.29
74069363|NCT00283686|147690450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.73|TWO_SIDED|95.0|-4.54|6.5|||Mixed Models Analysis|adjusting for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change mL/min/1.73 m\^2 between low and standard blood pressure groups|||6.50|-4.54|0.73
74069364|NCT00283686|147690451|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.0228|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|adjusting for age, sex, race, and clinical site||||0.95|0.53|0.0228
74069365|NCT00283686|147690451|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.59|TWO_SIDED|95.0|0.7|1.22|||Regression, Cox|adjusting for age, sex, race, and clinical site||||1.22|0.70|0.59
74069366|NCT00283686|147690452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016||||0.87|TWO_SIDED|95.0|-0.19|0.17|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.17|-0.19|0.87
74069367|NCT00283686|147690452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13||||0.14|TWO_SIDED|95.0|-0.046|0.31|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.31|-0.046|0.14
74069368|NCT00283686|147690453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.0221|TWO_SIDED|95.0|0.036|0.46|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.46|0.036|0.0221
74069369|NCT00283686|147690453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23||||0.0339|TWO_SIDED|95.0|-0.44|-0.018|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||-0.018|-0.44|0.0339
74069370|NCT02970669|147690454|SUPERIORITY||Ratio of Geometric Means (SacVal/Ena)|0.9456||||0.0895|TWO_SIDED|95.0|0.8863|1.0088|||ANCOVA|model for a log-scaled response with treatment group as a class variable and the baseline value in logarithmic scale as a continuous covariate.||||1.0088|0.8863|0.0895
74069371|NCT02970669|147690455|SUPERIORITY||Mean Difference (Net)|293.6||||0.6316|TWO_SIDED|95.0|-916.5|1503.8|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||1503.8|-916.5|0.6316
74069372|NCT02970669|147690457|SUPERIORITY||Mean Difference (Net)|2.038||||0.057|TWO_SIDED|95.0|-0.062|4.138|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||4.138|-0.062|0.0570
74069373|NCT02970669|147690458|SUPERIORITY||Mean Difference (Net)|2.478||||0.0121|TWO_SIDED|95.0|0.553|4.403|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||4.403|0.553|0.0121
74069374|NCT00319956|147690481|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.20
74069375|NCT02607800|147690489|NON_INFERIORITY|Noninferiority was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 was greater than -5%. If the lower bound of the CI was greater than -5% (ie, the noninferiority null hypothesis was rejected), a 2-sided stratified Cochran-Mantel-Haenszel test was to be used to test for the superiority of SOF/VEL/VOX for 8 weeks over SOF/VEL for 12 weeks at a significance level of 0.05.|Difference in proportions|-3.2|||||TWO_SIDED|95.0|-6.0|-0.4|||||Difference in proportions between treatment groups and associated 95% CI were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||-0.4|-6.0|
74069376|NCT01202747|147690512|SUPERIORITY_OR_OTHER|||||||0.0005||||||p\<0.05 considered statistically significant|Regression, Linear|||||||0.0005
74069377|NCT02292238|147690523|OTHER||Mean Difference (Net)|1.8691|STANDARD_DEVIATION|5.5727||0.125|TWO_SIDED|||||Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|t-test, 2 sided|Equal variance t-test.||Power was calculated based on expected difference in change on the ADAS-Cog of 3 points between the treatment and control groups. Estimates based on using a two-sided alpha of 0.05 and a standard deviation of 4, enrolling 29 patients per group, (N = 58) suggest 80% power to detect a mean change of 3 between treatment and placebo.||||0.125
74069378|NCT02292238|147690524|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-0.00184|STANDARD_DEVIATION|0.0225||0.7529|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.7529
74069379|NCT02292238|147690525|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-1.0636|STANDARD_DEVIATION|4.8176||0.3687|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.3687
74069380|NCT02292238|147690526|OTHER||Mean Difference (Net)|1.8203|STANDARD_DEVIATION|13.8988||0.485|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.4850
74069381|NCT02292238|147690527|OTHER||Mean Difference (Net)|0.1907|STANDARD_DEVIATION|0.3097||0.0337|TWO_SIDED|||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|Equal variance t-test.||||||0.0337
74069382|NCT02292238|147690528|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-1.6161|STANDARD_DEVIATION|5.6812||0.315|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.315
74069383|NCT00494806|147690541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7279|STANDARD_ERROR_OF_MEAN|0.15|<|0.05||95.0|0.3174|1.1383|||t-test, 2 sided|df = 64|Relative risk not calculated.|"No differences in time to first flatus between the rocking and non rocking groups is the null hypothesis.~Sample size calculations by setting the criterion for significance at .05, two-tailed test (an effect in either directions was accepted), and power at .80. A total sample of 54 participants was determined necessary to yield statistically significant results (27 in Group A and 27 in Group B)."||1.1383|0.3174|<0.05
74069384|NCT01533428|147690558|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.6||||0.025|TWO_SIDED|95.0|-12.3|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level||-0.8|-12.3|0.025
74069385|NCT01533428|147690559|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.1||||0.018|TWO_SIDED|95.0|-12.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-1.2|-12.9|0.018
74069386|NCT01533428|147690560|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1||||0.208|TWO_SIDED|95.0|-10.4|2.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 2.||2.3|-10.4|0.208
74069387|NCT01533428|147690560|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.7||||0.036|TWO_SIDED|95.0|-13.1|-0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 3.||-0.4|-13.1|0.036
74069388|NCT01533428|147690560|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2||||0.027|TWO_SIDED|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 4.||-0.8|-13.5|0.027
74069389|NCT01533428|147690560|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.3||||0.024|TWO_SIDED|95.0|-13.6|-1.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 5.||-1.0|-13.6|0.024
74069390|NCT01533428|147690560|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.051|TWO_SIDED|95.0|-12.6|0.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 6.||0.0|-12.6|0.051
74069391|NCT01533428|147690560|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.1||||0.012|TWO_SIDED|95.0|-14.4|-1.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 7.||-1.8|-14.4|0.012
74069392|NCT01533428|147690560|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2||||0.026|TWO_SIDED|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 8.||-0.8|-13.5|0.026
74069393|NCT01533428|147690560|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.9||||0.032|TWO_SIDED|95.0|-13.2|-0.6|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 9.||-0.6|-13.2|0.032
74069394|NCT01533428|147690560|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.5||||0.02|TWO_SIDED|95.0|-13.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 10.||-1.2|-13.9|0.020
74069395|NCT01533428|147690560|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.4||||0.022|TWO_SIDED|95.0|-13.7|-1.1|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 11.||-1.1|-13.7|0.022
74069396|NCT01533428|147690560|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.0||||0.005|TWO_SIDED|95.0|-15.3|-2.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 12.||-2.7|-15.3|0.005
74069397|NCT01533428|147690562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.108|TWO_SIDED|95.0|0.9|2.2|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.2|0.9|0.108
74069398|NCT01533428|147690562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.05|TWO_SIDED|95.0|1.0|2.4|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.4|1.0|0.050
74069399|NCT01533428|147690563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.403|TWO_SIDED|95.0|0.7|2.1|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.1|0.7|0.403
74069400|NCT01533428|147690563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.446|TWO_SIDED|95.0|0.7|2.0|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.0|0.7|0.446
74069401|NCT01533428|147690564|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.072
74069402|NCT01533428|147690565|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.075
74069403|NCT01533428|147690566|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.169
74069404|NCT01533428|147690567|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.32|TWO_SIDED|95.0|-1.6|5.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 8 was made using two-sided tests at the 5% significance level.||5.0|-1.6|0.320
74069405|NCT01533428|147690567|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2||||0.473|TWO_SIDED|95.0|-2.1|4.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 12 was made using two-sided tests at the 5% significance level.||4.5|-2.1|0.473
74069406|NCT01533428|147690567|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.514|TWO_SIDED|95.0|-4.4|2.2|||ANCOVA|||The statistical comparison between Baseline and Week 2 was made using two-sided tests at the 5% significance level.||2.2|-4.4|0.514
74069407|NCT01533428|147690568|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.719|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.||0.7|-0.5|0.719
74069408|NCT01533428|147690568|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.334|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.||0.3|-0.8|0.334
74069409|NCT01533428|147690568|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.726|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.||0.5|-0.7|0.726
74069410|NCT01533428|147690569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.841|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.||0.5|-0.6|0.841
74069411|NCT01533428|147690569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.171|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.||0.2|-0.9|0.171
74069412|NCT01533428|147690569|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.595|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.||0.4|-0.7|0.595
74069413|NCT01533428|147690571|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.0||||0.03|TWO_SIDED|95.0|-17.2|-0.9|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-0.9|-17.2|0.030
74069414|NCT01533428|147690571|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5||||0.02|TWO_SIDED|95.0|-17.4|-1.5|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-1.5|-17.4|0.020
74069415|NCT01364870|147690576|SUPERIORITY|||||||0.016||||||The p value was adjusted using Bonferroni's method to account for the multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.||||0.016
74069416|NCT01364870|147690577|SUPERIORITY|||||||0.008||||||P-value was adjusted using Bonferroni's method to account for multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.||||0.008
74069417|NCT05188521|147690615|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
74069418|NCT05188521|147690616|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||0.593
74069419|NCT05188521|147690617|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
74069420|NCT05188521|147690618|SUPERIORITY|||||||0.138|||||||Wilcoxon (Mann-Whitney)|||||||0.138
74069421|NCT05188521|147690619|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
74069422|NCT05188521|147690620|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
74069423|NCT05188521|147690621|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
74069424|NCT05188521|147690622|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
74069425|NCT01341639|147690625|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|11.37|||<|0.001|TWO_SIDED|95.0|8.44|14.68||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRP|PR5I minus INFANRIX™ hexa|14.68|8.44|< 0.001
74069426|NCT01341639|147690625|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.95|0.96||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Diphtheria|PR5I minus INFANRIX™ hexa|0.96|-0.95|< 0.001
74069427|NCT01341639|147690625|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.71|0.74|||Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Tetanus|PR5I minus INFANRIX™ hexa|0.74|-0.71|< 0.001
73883420|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.228|||<|0.0001|TWO_SIDED|95.0|2.358|4.097|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)||4.097|2.358|<.0001
73883421|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.268|||<|0.0001|TWO_SIDED|95.0|2.418|4.119|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.119|2.418|<.0001
74069428|NCT01341639|147690625|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|TWO_SIDED|95.0|-0.51|1.07||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV1|PR5I minus INFANRIX™ hexa|1.07|-0.51|< 0.001
74069429|NCT01341639|147690625|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|TWO_SIDED|95.0|-0.69|1.21||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV2|PR5I minus INFANRIX™ hexa|1.21|-0.69|< 0.001
74069430|NCT01341639|147690625|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.73||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV3|PR5I minus INFANRIX™ hexa|0.73|-0.7|< 0.001
74069431|NCT01341639|147690626|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.58|||<|0.001|TWO_SIDED|95.0|-0.49|1.85||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for HBsAg|PR5I minus INFANRIX™ hexa|1.85|-0.49|< 0.001
74069432|NCT01341639|147690626|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|1.33|||<|0.001|TWO_SIDED|95.0|0.32|2.86||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PT|PR5I minus INFANRIX™ hexa|2.86|0.32|< 0.001
74069433|NCT01341639|147690626|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-2.59|||<|0.001|TWO_SIDED|95.0|-4.39|-1.29||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for FHA|PR5I minus INFANRIX™ hexa|-1.29|-4.39|< 0.001
74069434|NCT01341639|147690626|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.03|||<|0.001|TWO_SIDED|95.0|-1.4|1.52||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRN|PR5I minus INFANRIX™ hexa|1.52|-1.4|< 0.001
74069435|NCT01341639|147690628|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.26|||<|0.001|TWO_SIDED|95.0|-2.82|2.25||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Measles|PR5I minus INFANRIX™ hexa|2.25|-2.82|< 0.001
74069436|NCT01341639|147690628|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|3.07|||<|0.001|TWO_SIDED|95.0|-0.12|6.4||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Mumps|PR5I minus INFANRIX™ hexa|6.4|-0.12|< 0.001
74069437|NCT01341639|147690628|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.39|||<|0.001|TWO_SIDED|95.0|-1.5|2.34||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Rubella|PR5I minus INFANRIX™ hexa|2.34|-1.5|< 0.001
74069438|NCT01341639|147690628|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.02|||<|0.001|TWO_SIDED|95.0|-2.11|2.06||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Varicella|PR5I minus INFANRIX™ hexa|2.06|-2.11|< 0.001
74069439|NCT01341639|147690629|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-1.9|0.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or systemic AEs|PR5I minus INFANRIX™ hexa|0.4|-1.9|
74069440|NCT01341639|147690629|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.3|||||TWO_SIDED|95.0|-1.8|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or vaccine-related systemic AEs|PR5I minus INFANRIX™ hexa|1.1|-1.8|
74069441|NCT01341639|147690629|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-2.1|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 ISR|PR5I minus INFANRIX™ hexa|4.3|-2.1|
74069442|NCT01341639|147690629|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-2.4|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited ISR|PR5I minus INFANRIX™ hexa|4.3|-2.4|
74069443|NCT01341639|147690629|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-2.4|0.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 systemic AE|PR5I minus INFANRIX™ hexa|0.3|-2.4|
74069444|NCT01341639|147690629|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-3.2|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related systemic AE|PR5I minus INFANRIX™ hexa|1.3|-3.2|
74069445|NCT01341639|147690629|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.5|||||TWO_SIDED|95.0|-3.3|0.2|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited systemic AE|PR5I minus INFANRIX™ hexa|0.2|-3.3|
74069446|NCT01341639|147690629|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.3|||||TWO_SIDED|95.0|-3.7|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related solicited systemic AE|PR5I minus INFANRIX™ hexa|1.1|-3.7|
74069447|NCT01341639|147690630|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|4.8|||||TWO_SIDED|95.0|-0.5|10.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site erythema|PR5I minus INFANRIX™ hexa|10.1|-0.5|
74069448|NCT01341639|147690630|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-3.2|6.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site pain|PR5I minus INFANRIX™ hexa|6.8|-3.2|
74069449|NCT01341639|147690630|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-1.6|9.6|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site swelling|PR5I minus INFANRIX™ hexa|9.6|-1.6|
74069450|NCT01341639|147690631|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-1.8|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site bruising|PR5I minus INFANRIX™ hexa|2.1|-1.8|
74069451|NCT01341639|147690631|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-0.6|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haematoma|PR5I minus INFANRIX™ hexa|2.1|-0.6|
74069452|NCT01341639|147690631|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-2.3|0.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haemorrhage|PR5I minus INFANRIX™ hexa|0.8|-2.3|
74069453|NCT01341639|147690631|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.7|||||TWO_SIDED|95.0|-7.8|0.5|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site induration|PR5I minus INFANRIX™ hexa|0.5|-7.8|
74069454|NCT01341639|147690631|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-1.7|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site nodule|PR5I minus INFANRIX™ hexa|1.3|-1.7|
74069455|NCT01341639|147690631|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.1||||||95.0|-0.6|3.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site warmth|PR5I minus INFANRIX™ hexa|3|-0.6|
74069456|NCT01341639|147690632|OTHER|Miettinen \& Nurminen method.|Risk Difference (RD)|-2.5|||||TWO_SIDED|95.0|-6.3|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Crying|PR5I minus INFANRIX™ hexa|1.4|-6.3|
74069457|NCT01341639|147690632|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-8.4|2.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Decreased appetite|PR5I minus INFANRIX™ hexa|2.3|-8.4|
74069458|NCT01341639|147690632|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|2.1|||||TWO_SIDED|95.0|-1.7|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Irritability|PR5I minus INFANRIX™ hexa|6|-1.7|
74069459|NCT01341639|147690632|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-6.7|3.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Pyrexia|PR5I minus INFANRIX™ hexa|3.4|-6.7|
74069460|NCT01341639|147690632|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.2|||||TWO_SIDED|95.0|-7.8|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Somnolence|PR5I minus INFANRIX™ hexa|1.4|-7.8|
74069461|NCT01341639|147690632|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-4.4|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Vomiting|PR5I minus INFANRIX™ hexa|6|-4.4|
74069462|NCT01132118|147690665|SUPERIORITY_OR_OTHER|||||||0.93||||||Unadjusted|Wilcoxon (Mann-Whitney)|||The P-value calculated was for the difference betweeen the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.930
74069463|NCT01132118|147690665|SUPERIORITY_OR_OTHER|||||||0.785||||||Adjusted for weight change.|Regression, Linear|||The P-value was calculated for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.785
74069464|NCT01132118|147690666|SUPERIORITY_OR_OTHER|||||||0.575||||||Unadjusted P-value|Wilcoxon (Mann-Whitney)|||P-value for the difference between change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.575
74069465|NCT01132118|147690666|SUPERIORITY_OR_OTHER|||||||0.308||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.308
74069466|NCT01132118|147690667|SUPERIORITY_OR_OTHER|||||||0.468||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference betweeen change during hydroxychloroquine versus placebo suing Wilcoxon signed-rank tests.||||0.468
74069467|NCT01132118|147690667|SUPERIORITY_OR_OTHER|||||||0.902||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.902
74069468|NCT01132118|147690668|SUPERIORITY_OR_OTHER|||||||0.004||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.004
74069469|NCT01132118|147690668|SUPERIORITY_OR_OTHER|||||||0.004||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.004
73883422|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.291|||<|0.0001|TWO_SIDED|95.0|2.443|4.139|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.139|2.443|<.0001
74069470|NCT01132118|147690669|SUPERIORITY_OR_OTHER|||||||0.009||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.009
74069471|NCT01132118|147690669|SUPERIORITY_OR_OTHER|||||||0.011||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.011
74069472|NCT01132118|147690670|SUPERIORITY_OR_OTHER|||||||0.73||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.730
74069473|NCT01132118|147690670|SUPERIORITY_OR_OTHER|||||||0.208||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.208
74069474|NCT01132118|147690671|SUPERIORITY_OR_OTHER|||||||0.487||||||Unadjusted P-value.|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.487
74069475|NCT01132118|147690671|SUPERIORITY_OR_OTHER|||||||0.884||||||P-value adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxycholorquine versus placebo from a linear regression model.||||0.884
74069476|NCT02780661|147690697|OTHER||Least square (LS) mean difference|-0.86||||0.0144|TWO_SIDED|95.0|-1.53|-0.196||Log10 change from baseline in aerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.||-0.196|-1.530|0.0144
74069477|NCT02780661|147690698|OTHER||LS mean difference|-0.48||||0.1879|TWO_SIDED|95.0|-1.23|0.261||Log10 change from baseline in anaerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.||0.261|-1.230|0.1879
74069478|NCT00494975|147690703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.32|<|0.05|TWO_SIDED|95.0|0.31|1.56|||generalized estimating equations (GEE)|||The VAS score of pruritus intensity was recorded for each participant at baseline and weekly until week 12 so that each one had 12 repeatedly measured data scores. To investigate the predictive effects of age, sex, comorbid diseases, phototherapy, and results of blood laboratory exams on the intensity of pruritus, marginal linear regression model was fitted to the repeatedly measured VAS score data using the generalized estimating equations (GEE) method.||1.56|0.31|<0.05
74069479|NCT01806688|147690705|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
74069480|NCT01806688|147690706|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
73888334|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|196.0|||<|0.0001|TWO_SIDED|95.0|107.4|284.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||284.6|107.4|<0.0001
74069481|NCT01806688|147690708|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
74069482|NCT02322879|147690726|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
74069483|NCT02295774|147690727|SUPERIORITY_OR_OTHER||Mc Nemar's χ2 test|0.0|||||TWO_SIDED|||||||Mc Nemar's χ2 test was not applicable because there is no change between visits.|Mc Nemar's χ2 test was not applicable because there is no change between visits.|"The results of the γH2AX analysis were listed and summarised by frequency tables by visit and colonic region.~The results were compared between Visit 2 and Visit 1 for each colonic region and overall using the Mc Nemar's χ2 test.~In case of the presence of at least one positive colonic region, that visit was to be considered as 'Positive' for the overall γH2AX analysis."||||
74069484|NCT02324972|147690733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.636|TWO_SIDED|95.0|-1.3|1.25|||ANCOVA|||A sample size of 20 subjects per group was assumed to have 80% power to allow detection of a statistically significant difference in change from baseline in TLSS between the 2 groups, if the effect size was approximately less than or equal to 0.9. This is equivalent to detecting a difference of -4.5 between the 2 groups with a common standard deviation of 5. The primary analysis was doing using last observation carried forward (LOCF) imputed data.||1.25|-1.30|0.636
74069485|NCT02324972|147690734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.677|TWO_SIDED|95.0|-0.44|0.68|||ANOVA|||||0.68|-0.44|0.677
74069486|NCT02324972|147690735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.219||||0.802|TWO_SIDED|95.0|-1.983|1.544|||ANOVA|||||1.544|-1.983|0.802
74069487|NCT02324972|147690736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108||||0.976|TWO_SIDED|95.0|-7.076|7.292|||ANOVA|||||7.292|-7.076|0.976
74069488|NCT02324972|147690737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.233|TWO_SIDED|95.0|-1.68|6.72|||ANOVA|||||6.72|-1.68|0.233
74069489|NCT02337933|147690740|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
74069490|NCT02337933|147690741|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
74069491|NCT02337933|147690742|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
74069492|NCT02337933|147690743|OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
74069493|NCT02337933|147690744|OTHER|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||||||0.575
74069494|NCT02337933|147690745|OTHER|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
74069495|NCT02337933|147690746|OTHER|||||||0.373|||||||Wilcoxon (Mann-Whitney)|||||||0.373
74069496|NCT02337933|147690747|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
74069497|NCT02337933|147690748|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
74069498|NCT02337933|147690749|OTHER|||||||0.224|||||||Wilcoxon (Mann-Whitney)|||||||0.224
74069499|NCT02337933|147690750|OTHER|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||||||0.116
74069500|NCT02337933|147690751|OTHER|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
74069501|NCT02337933|147690752|OTHER|||||||0.999|||||||Wilcoxon (Mann-Whitney)|||||||0.999
74069502|NCT01617577|147690757|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||ADAScog scores at baseline vs final visit (wk 14); null hypothesis is there is no difference between scores||||0.36
74069503|NCT01617577|147690757|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PAL(mem) at baseline and 14 wk (final visit): null hypothesis is thereis no difference in score||||0.058
74069504|NCT01617577|147690757|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PALtot trials adj at baseline vs 14wk (final visit)||||0.034
74069505|NCT00384033|147690758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.198|TWO_SIDED|95.0|-0.6|2.7||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 50 mg, HAM-D17 total score was evaluated using analysis of covariance (ANCOVA) with treatment and site as factors and baseline HAM-D17 score as the covariate.||2.70|-0.60|0.198
74069506|NCT00384033|147690758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.028|TWO_SIDED|95.0|0.2|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 100 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.||3.40|0.20|0.028
74069507|NCT00384033|147690758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.047|TWO_SIDED|95.0|0.0|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.||3.40|0.00|0.047
73883423|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.331|||<|0.0001|TWO_SIDED|95.0|2.474|4.189|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.189|2.474|<.0001
73883424|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.354|||<|0.0001||95.0|2.484|4.224|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.224|2.484|<.0001
74069508|NCT00384033|147690759|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 50 mg, CGI-I was evaluated using Cochran-Mantel-Haenszel (CMH) test with treatment as a factor and controlling for center.||||0.110
74069509|NCT00384033|147690759|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 100 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.||||0.009
74069510|NCT00384033|147690759|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For Duloxetine 60 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.||||0.008
74069511|NCT00384033|147690760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.248|TWO_SIDED|95.0|-0.1|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.40|-0.10|0.248
74069512|NCT00384033|147690760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.011|TWO_SIDED|95.0|0.1|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.60|0.10|0.011
74069513|NCT00384033|147690760|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3||||0.026|TWO_SIDED|95.0|0.0|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.60|0.00|0.026
74069514|NCT00384033|147690761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.149|TWO_SIDED|95.0|-0.6|4.0||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||4.00|-0.60|0.149
74069515|NCT00384033|147690761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.004|TWO_SIDED|95.0|1.1|5.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||5.60|1.10|0.004
74069516|NCT00384033|147690761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.005|TWO_SIDED|95.0|1.1|5.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||5.80|1.10|0.005
74069517|NCT00384033|147690762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.473|TWO_SIDED|95.0|-0.22|0.46||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.46|-0.22|0.473
74069518|NCT00384033|147690762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.119|TWO_SIDED|95.0|-0.07|0.61||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.61|-0.07|0.119
74069519|NCT00384033|147690762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.71|TWO_SIDED|95.0|-0.27|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.40|-0.27|0.710
74069520|NCT00384033|147690763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.215|TWO_SIDED|95.0|-0.3|1.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||1.50|-0.30|0.215
74069521|NCT00384033|147690763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.005|TWO_SIDED|95.0|0.4|2.3||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||2.30|0.40|0.005
74069522|NCT00384033|147690763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.024|TWO_SIDED|95.0|0.2|2.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||2.10|0.20|0.024
74069523|NCT00384033|147690764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.1|TWO_SIDED|95.0|-0.1|1.17||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.17|-0.10|0.100
74069524|NCT00384033|147690764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.014|TWO_SIDED|95.0|0.16|1.42||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.42|0.16|0.014
74069525|NCT00384033|147690764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.032|TWO_SIDED|95.0|0.06|1.38||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.38|0.06|0.032
74069526|NCT00384033|147690765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.445|TWO_SIDED|95.0|-0.2|0.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.50|-0.20|0.445
74069527|NCT00384033|147690765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.056|TWO_SIDED|95.0|0.0|0.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.70|-0.00|0.056
74069528|NCT00384033|147690765|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.90|0.10|0.006
74069529|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.124|TWO_SIDED|95.0|-0.9|7.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||7.90|-0.90|0.124
74069530|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.035|TWO_SIDED|95.0|0.3|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||9.10|0.30|0.035
74069531|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.1||||0.093|TWO_SIDED|95.0|-0.7|8.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||8.80|-0.70|0.093
74069532|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1||||0.177|TWO_SIDED|95.0|-1.4|7.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||7.70|-1.40|0.177
74069533|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.048|TWO_SIDED|95.0|0.1|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||9.10|0.10|0.048
74069534|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.088|TWO_SIDED|95.0|-0.5|8.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||8.10|-0.50|0.088
74069535|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.122|TWO_SIDED|95.0|-1.0|8.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||8.40|-1.00|0.122
74069536|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8||||0.015|TWO_SIDED|95.0|1.1|10.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||10.50|1.10|0.015
74069537|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.103|TWO_SIDED|95.0|-0.8|9.2||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||9.20|-0.80|0.103
73883425|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.395|||<|0.0001|TWO_SIDED|95.0|2.489|4.3|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.300|2.489|<.0001
74069538|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.384|TWO_SIDED|95.0|-1.7|4.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||4.50|-1.70|0.384
74069539|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.221|TWO_SIDED|95.0|-1.2|5.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||5.10|-1.20|0.221
74069540|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.411|TWO_SIDED|95.0|-1.9|4.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||4.70|-1.90|0.411
74069541|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.412|TWO_SIDED|95.0|-2.8|6.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||6.70|-2.80|0.412
74069542|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9||||0.042|TWO_SIDED|95.0|0.2|9.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||9.60|0.20|0.042
74069543|NCT00384033|147690766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.155|TWO_SIDED|95.0|-1.2|7.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||7.80|-1.20|0.155
74069544|NCT00290745|147690767|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change in Tumor volume between baseline and Month 6||||0.07
74069545|NCT00290745|147690768|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in Tumor volume between baseline and Month 6||||<0.001
74069546|NCT00290745|147690771|OTHER|||||||0.538|||||||Kruskal-Wallis|||||||0.538
74069547|NCT00290745|147690772|OTHER|||||||0.02|||||||Kruskal-Wallis|||||||0.02
74069548|NCT00290745|147690773|OTHER|||||||0.714|||||||Kruskal-Wallis|||||||0.714
74069549|NCT00290745|147690774|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
74069550|NCT00290745|147690775|OTHER|||||||0.906|||||||Kruskal-Wallis|||||||0.906
74069551|NCT03019965|147690838|SUPERIORITY||Risk Ratio (RR)|0.95||||0.156|TWO_SIDED|95.0|0.87|1.02|||Chi-squared||||The efficacy of the maneuver was evaluated by calculating the absolute risk reduction and the number needed to treat.|1.02|0.87|0.156
74069552|NCT03019965|147690839|SUPERIORITY||Risk Ratio (RR)|2.98||||0.722|TWO_SIDED|95.0|0.31|28.45|||Chi-squared|||||28.45|0.31|0.722
74069553|NCT01325207|147690864|OTHER||||||||||||||||||The Maximum Tolerated Dose (MTD) was determined to be 80mg IT every two weeks. This is based on no DLTs being seeing in Cohorts 1-4 with lower doses and 1 DLT out of 7 patients observed at 80mg IT in Cohort 5.|||
74069554|NCT01166568|147690927|SUPERIORITY||binomial distribution|0.75||||0.025|ONE_SIDED|97.5|0.75|||the p-value is adjusted for multiple comparisons|Fisher Exact|||"The PSI procedure is defined as successful if 75% of subjects achieve the first primary endpoint or second primary endpoint. The corresponding statistical hypotheses are as follows:~H0 (null hypothesis): p1 ≤ 0.75 Ha (alternative hypothesis): p1 \> 0.75, Where, p1 is the probability of subjects achieving the first primary endpoint. H0 (null hypothesis): p2 ≤ 0.75 Ha (alternative hypothesis): p2 \> 0.75, Where, p2 is the probability of subjects achieving the second primary endpoint."|||0.75|0.025
74069555|NCT03335371|147690943|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.087|<|0.0001|TWO_SIDED|95.0|-0.39|-0.04|||ANCOVA|||||-0.04|-0.39|<0.0001
74069556|NCT00249821|147690959|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||"Month 12: Analysis of co-variance (ANCOVA) method with covariates height and age at baseline was used to calculate presented p-value."||||0.001
74069557|NCT00249821|147690960|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||"Change at Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.012
74069558|NCT00249821|147690960|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||"Change at Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.002
74069559|NCT00249821|147690961|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.022
74069560|NCT00249821|147690961|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.002
74069561|NCT00249821|147690962|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||ANCOVA|||"Change at Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.029
74069562|NCT00249821|147690963|SUPERIORITY_OR_OTHER|||||||0.972||95.0|||||ANCOVA|||"Change at Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.972
74069563|NCT00249821|147690964|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.058
74069564|NCT00249821|147690964|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.026
74069565|NCT00249821|147690965|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.793
74069566|NCT00249821|147690965|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.055
74069567|NCT03387033|147691016|OTHER||||||<|0.005|||||||Paired t-test|||||||<0.005
74069568|NCT03387033|147691017|OTHER||||||<|0.05|||||||Paired t-test|||||||<0.05
74069569|NCT03387033|147691018|OTHER||||||<|0.05|||||||Paired t-test|||||||<0.05
74069570|NCT00601484|147691019|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-1.36|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-2.203|-0.51||||||Analysis was based on analysis of covariance (ANCOVA) model with terms for treatment, age, gender, body mass index (BMI), baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.510|-2.203|
74069571|NCT00601484|147691020|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|-1.363|0.011||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.011|-1.363|
74069572|NCT00601484|147691020|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.498|||TWO_SIDED|90.0|-1.969|-0.297||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.297|-1.969|
74069573|NCT00601484|147691020|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-1.79|0.09||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.090|-1.790|
74069574|NCT00601484|147691020|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.538|||TWO_SIDED|90.0|-1.356|0.457||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.457|-1.356|
74069575|NCT00601484|147691021|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.68|STANDARD_ERROR_OF_MEAN|6.727|||TWO_SIDED|90.0|-19.954|2.601||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.601|-19.954|
74069576|NCT00601484|147691021|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.74|STANDARD_ERROR_OF_MEAN|8.47|||TWO_SIDED|90.0|-31.948|-3.523||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-3.523|-31.948|
74069577|NCT00601484|147691021|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-20.66|STANDARD_ERROR_OF_MEAN|8.138|||TWO_SIDED|90.0|-34.347|-6.971||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-6.971|-34.347|
74069578|NCT00601484|147691021|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.58|STANDARD_ERROR_OF_MEAN|9.532|||TWO_SIDED|90.0|-29.612|2.452||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.452|-29.612|
74069579|NCT00601484|147691021|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.75|STANDARD_ERROR_OF_MEAN|8.807|||TWO_SIDED|90.0|-22.58|7.08||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.080|-22.580|
74069580|NCT00601484|147691022|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.721|||TWO_SIDED|90.0|-1.768|0.65||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.650|-1.768|
74069581|NCT00601484|147691022|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.898|||TWO_SIDED|90.0|-2.723|0.297||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.297|-2.723|
74069582|NCT00601484|147691022|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.47|STANDARD_ERROR_OF_MEAN|1.311|||TWO_SIDED|90.0|-3.682|0.752||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.752|-3.682|
74069583|NCT00601484|147691022|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|-1.11|2.198||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.198|-1.110|
74069584|NCT00601484|147691022|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.114|||TWO_SIDED|90.0|-2.904|0.922||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.922|-2.904|
74069585|NCT00601484|147691023|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.41|STANDARD_ERROR_OF_MEAN|5.51|||TWO_SIDED|90.0|-13.65|4.826||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.826|-13.650|
74069586|NCT00601484|147691023|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.65|STANDARD_ERROR_OF_MEAN|7.041|||TWO_SIDED|90.0|-20.493|3.192||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||3.192|-20.493|
74069587|NCT00601484|147691023|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.72|STANDARD_ERROR_OF_MEAN|10.089|||TWO_SIDED|90.0|-26.775|7.343||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.343|-26.775|
74069588|NCT00601484|147691023|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.76|STANDARD_ERROR_OF_MEAN|7.532|||TWO_SIDED|90.0|-8.95|16.465||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||16.465|-8.950|
74069589|NCT00601484|147691023|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.72|STANDARD_ERROR_OF_MEAN|7.906|||TWO_SIDED|90.0|-22.299|4.851||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.851|-22.299|
74069590|NCT00601484|147691024|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.609|||TWO_SIDED|90.0|-0.776|1.265||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.265|-0.776|
74069591|NCT00601484|147691024|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.674|||TWO_SIDED|90.0|-1.22|1.044||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.044|-1.220|
74069592|NCT00601484|147691024|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.57|STANDARD_ERROR_OF_MEAN|1.009|||TWO_SIDED|90.0|-1.124|2.269||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.269|-1.124|
74069593|NCT00601484|147691024|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|90.0|-1.441|1.988||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.988|-1.441|
74069594|NCT00601484|147691024|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.99|STANDARD_ERROR_OF_MEAN|0.769|||TWO_SIDED|90.0|-0.307|2.283||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.283|-0.307|
74069595|NCT00601484|147691025|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.68|||||TWO_SIDED|90.0|-9.05|5.76||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||5.76|-9.05|
74069596|NCT00601484|147691025|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-2.78|||||TWO_SIDED|90.0|-12.65|4.24||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||4.24|-12.65|
74069597|NCT00601484|147691025|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|0.04|||||TWO_SIDED|90.0|-8.96|7.9||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||7.90|-8.96|
74069598|NCT00601484|147691025|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.38|||||TWO_SIDED|90.0|-11.57|8.28||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||8.28|-11.57|
74069599|NCT00601484|147691025|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|3.97|||||TWO_SIDED|90.0|-6.82|13.02||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||13.02|-6.82|
74069600|NCT00601484|147691026|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-2.414|0.983||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.983|-2.414|
74069601|NCT00601484|147691026|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|90.0|-1.548|2.384||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.384|-1.548|
74069602|NCT00601484|147691026|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|0.821|||TWO_SIDED|90.0|-0.075|2.693||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.693|-0.075|
74069603|NCT00601484|147691026|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|1.093|||TWO_SIDED|90.0|-2.178|1.512||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.512|-2.178|
74069604|NCT00601484|147691026|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.07|STANDARD_ERROR_OF_MEAN|1.208|||TWO_SIDED|90.0|0.038|4.112||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.112|0.038|
74069605|NCT00601484|147691027|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-6.41|||||TWO_SIDED|90.0|-33.33|18.68||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||18.68|-33.33|
74069606|NCT00601484|147691027|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|15.83|||||TWO_SIDED|90.0|-14.12|41.18||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||41.18|-14.12|
74069607|NCT00601484|147691027|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|19.17|||||TWO_SIDED|90.0|0.0|38.1||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||38.10|0.00|
74069608|NCT00601484|147691027|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-0.71|||||TWO_SIDED|90.0|-30.95|32.73||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||32.73|-30.95|
74069609|NCT00601484|147691027|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|34.89|||||TWO_SIDED|90.0|-4.57|70.0||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||70.00|-4.57|
74069610|NCT00601484|147691028|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.529|0.61||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.610|-0.529|
74069611|NCT00601484|147691028|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.334|||TWO_SIDED|90.0|-1.077|0.043||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.043|-1.077|
74069612|NCT00601484|147691028|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.366|||TWO_SIDED|90.0|-0.835|0.396||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.396|-0.835|
74069613|NCT00601484|147691028|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.294|||TWO_SIDED|90.0|-0.718|0.273||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.273|-0.718|
74069614|NCT00601484|147691028|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.442|||TWO_SIDED|90.0|-1.044|0.445||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.445|-1.044|
74069615|NCT00601484|147691029|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.24|||||TWO_SIDED|90.0|-27.56|5.37||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||5.37|-27.56|
74069616|NCT00601484|147691029|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-22.43|||||TWO_SIDED|90.0|-56.39|0.0||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-56.39|
74069617|NCT00601484|147691029|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-16.0|||||TWO_SIDED|90.0|-40.44|0.0||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-40.44|
74069618|NCT00601484|147691029|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-14.18|||||TWO_SIDED|90.0|-50.71|0.0||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-50.71|
74069619|NCT00601484|147691029|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-8.61|||||TWO_SIDED|90.0|-36.87|4.64||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||4.64|-36.87|
74069620|NCT00601484|147691030|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|12.495|||TWO_SIDED|90.0|-15.852|26.044||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||26.044|-15.852|
74069621|NCT00601484|147691030|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.27|STANDARD_ERROR_OF_MEAN|12.802|||TWO_SIDED|90.0|-17.216|25.764||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||25.764|-17.216|
74069622|NCT00601484|147691030|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.81|STANDARD_ERROR_OF_MEAN|13.741|||TWO_SIDED|90.0|-25.917|20.307||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||20.307|-25.917|
74069623|NCT00601484|147691030|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|12.416|||TWO_SIDED|90.0|-21.626|20.162||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||20.162|-21.626|
74069624|NCT00601484|147691030|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|10.51|STANDARD_ERROR_OF_MEAN|14.469|||TWO_SIDED|90.0|-13.858|34.868||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||34.868|-13.858|
74069625|NCT00601484|147691031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.63|STANDARD_ERROR_OF_MEAN|6.968|||TWO_SIDED|90.0|-8.049|15.316||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||15.316|-8.049|
74069626|NCT00601484|147691031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.19|STANDARD_ERROR_OF_MEAN|7.353|||TWO_SIDED|90.0|-9.153|15.533||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||15.533|-9.153|
74069627|NCT00601484|147691031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|7.651|||TWO_SIDED|90.0|-13.806|11.932||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||11.932|-13.806|
74069628|NCT00601484|147691031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.79|STANDARD_ERROR_OF_MEAN|7.543|||TWO_SIDED|90.0|-5.901|19.486||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||19.486|-5.901|
74069629|NCT00601484|147691031|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.77|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|90.0|-9.221|18.765||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||18.765|-9.221|
74069630|NCT00601484|147691032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.407|||TWO_SIDED|90.0|-1.546|-0.182||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.182|-1.546|
74069631|NCT00601484|147691032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.38|STANDARD_ERROR_OF_MEAN|0.484|||TWO_SIDED|90.0|-2.196|-0.57||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.570|-2.196|
74069632|NCT00601484|147691032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|90.0|-2.204|-0.388||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.388|-2.204|
74069633|NCT00601484|147691032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.553|||TWO_SIDED|90.0|-2.032|-0.172||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.172|-2.032|
74069634|NCT00601484|147691032|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|0.512|||TWO_SIDED|90.0|-1.878|-0.152||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.152|-1.878|
74069635|NCT00601484|147691033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-16.24|STANDARD_ERROR_OF_MEAN|8.064|||TWO_SIDED|90.0|-29.757|-2.718||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-2.718|-29.757|
74069636|NCT00601484|147691033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-27.96|STANDARD_ERROR_OF_MEAN|10.059|||TWO_SIDED|90.0|-44.846|-11.075||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-11.075|-44.846|
73883426|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.417|||<|0.0001|TWO_SIDED|95.0|2.486|4.348|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.348|2.486|<.0001
74069637|NCT00601484|147691033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-25.72|STANDARD_ERROR_OF_MEAN|11.508|||TWO_SIDED|90.0|-45.079|-6.369||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-6.369|-45.079|
74069638|NCT00601484|147691033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.56|STANDARD_ERROR_OF_MEAN|12.157|||TWO_SIDED|90.0|-40.017|0.902||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.902|-40.017|
74069639|NCT00601484|147691033|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|11.124|||TWO_SIDED|90.0|-40.633|-3.171||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-3.171|-40.633|
74069640|NCT00601484|147691034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|-2.942|-0.057||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.057|-2.942|
74069641|NCT00601484|147691034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.08|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|90.0|-3.458|-0.705||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.705|-3.458|
74069642|NCT00601484|147691034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.13|STANDARD_ERROR_OF_MEAN|1.267|||TWO_SIDED|90.0|-4.265|-0.004||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.004|-4.265|
74069643|NCT00601484|147691034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.531|||TWO_SIDED|90.0|-4.029|1.124||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.124|-4.029|
74069644|NCT00601484|147691034|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.24|STANDARD_ERROR_OF_MEAN|1.293|||TWO_SIDED|90.0|-4.419|-0.063||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.063|-4.419|
74069645|NCT00601484|147691035|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-7.93|||||TWO_SIDED|90.0|-27.32|11.32||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||11.32|-27.32|
74069646|NCT00601484|147691035|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-17.9|||||TWO_SIDED|90.0|-42.04|4.37||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||4.37|-42.04|
74069647|NCT00601484|147691035|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-24.44|||||TWO_SIDED|90.0|-51.58|0.67||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||0.67|-51.58|
74069648|NCT00601484|147691035|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-7.5|||||TWO_SIDED|90.0|-41.71|17.33||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||17.33|-41.71|
74069649|NCT00601484|147691035|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-21.37|||||TWO_SIDED|90.0|-54.76|7.92||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||7.92|-54.76|
74069650|NCT00601484|147691036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.165|||TWO_SIDED|90.0|-0.591|-0.04||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.040|-0.591|
74069651|NCT00601484|147691036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|90.0|-0.734|0.02||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.020|-0.734|
74069652|NCT00601484|147691036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.211|||TWO_SIDED|90.0|-0.724|-0.015||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.015|-0.724|
74069653|NCT00601484|147691036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|90.0|-0.806|-0.005||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.005|-0.806|
73888335|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|133.9||||0.0034|TWO_SIDED|95.0|45.0|222.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||222.8|45.0|0.0034
74069654|NCT00601484|147691036|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.206|||TWO_SIDED|90.0|-0.47|0.223||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.223|-0.470|
74069655|NCT00601484|147691037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-15.34|STANDARD_ERROR_OF_MEAN|8.425|||TWO_SIDED|90.0|-29.468|-1.209||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-1.209|-29.468|
74069656|NCT00601484|147691037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-16.97|STANDARD_ERROR_OF_MEAN|11.102|||TWO_SIDED|90.0|-35.608|1.665||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.665|-35.608|
74069657|NCT00601484|147691037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-18.04|STANDARD_ERROR_OF_MEAN|10.358|||TWO_SIDED|90.0|-35.476|-0.613||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.613|-35.476|
74069658|NCT00601484|147691037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.48|STANDARD_ERROR_OF_MEAN|13.631|||TWO_SIDED|90.0|-42.418|3.46||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||3.460|-42.418|
74069659|NCT00601484|147691037|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.16|STANDARD_ERROR_OF_MEAN|10.097|||TWO_SIDED|90.0|-26.174|7.849||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.849|-26.174|
74069660|NCT00601484|147691038|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.404|||TWO_SIDED|90.0|-1.394|0.03||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.030|-1.394|
74069661|NCT00601484|147691038|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-1.149|0.468||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.468|-1.149|
74069662|NCT00601484|147691038|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.449|||TWO_SIDED|90.0|-1.443|0.156||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.156|-1.443|
74069663|NCT00601484|147691038|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.546|||TWO_SIDED|90.0|-1.046|0.931||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.931|-1.046|
74069664|NCT00601484|147691038|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.673|||TWO_SIDED|90.0|-1.876|0.592||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.592|-1.876|
74069665|NCT00601484|147691039|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-34.25|STANDARD_ERROR_OF_MEAN|21.509|||TWO_SIDED|90.0|-72.879|4.375||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.375|-72.879|
74069666|NCT00601484|147691039|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-30.97|STANDARD_ERROR_OF_MEAN|24.418|||TWO_SIDED|90.0|-75.23|13.285||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||13.285|-75.230|
74069667|NCT00601484|147691039|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-37.18|STANDARD_ERROR_OF_MEAN|28.74|||TWO_SIDED|90.0|-90.62|16.265||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||16.265|-90.620|
74069668|NCT00601484|147691039|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.77|STANDARD_ERROR_OF_MEAN|43.222|||TWO_SIDED|90.0|-74.604|86.142||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||86.142|-74.604|
74069669|NCT00601484|147691039|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-21.35|STANDARD_ERROR_OF_MEAN|70.862|||TWO_SIDED|90.0|-164.142|121.438||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||121.438|-164.142|
74069670|NCT00601484|147691042|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.788|||TWO_SIDED|90.0|-2.562|0.081||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.081|-2.562|
74069671|NCT00601484|147691042|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.986|||TWO_SIDED|90.0|-2.782|0.535||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.535|-2.782|
74069672|NCT00601484|147691042|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.036|0.819||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.819|-3.036|
74069673|NCT00601484|147691042|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.816|||TWO_SIDED|90.0|-1.534|1.221||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.221|-1.534|
74069674|NCT00601484|147691042|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|1.083|||TWO_SIDED|90.0|-2.398|1.32||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.320|-2.398|
74069675|NCT00601484|147691043|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.99|STANDARD_ERROR_OF_MEAN|6.718|||TWO_SIDED|90.0|-22.25|0.277||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.277|-22.250|
74069676|NCT00601484|147691043|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.43|STANDARD_ERROR_OF_MEAN|8.66|||TWO_SIDED|90.0|-23.001|6.132||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||6.132|-23.001|
74069677|NCT00601484|147691043|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.14|STANDARD_ERROR_OF_MEAN|9.737|||TWO_SIDED|90.0|-24.602|8.327||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||8.327|-24.602|
74069678|NCT00601484|147691043|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|7.406|||TWO_SIDED|90.0|-13.948|11.04||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||11.040|-13.948|
74069679|NCT00601484|147691043|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.83|STANDARD_ERROR_OF_MEAN|9.352|||TWO_SIDED|90.0|-23.884|8.234||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||8.234|-23.884|
74069680|NCT00601484|147691044|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.064|||||TWO_SIDED|90.0|1.709|15.007||||||Week 6: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.||15.007|1.709|
74069681|NCT00601484|147691044|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.722|||||TWO_SIDED|90.0|0.756|9.795||||||Week 16: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.||9.795|0.756|
74069682|NCT00745251|147691065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.86|STANDARD_ERROR_OF_MEAN|5.95||0.0084|ONE_SIDED|95.0||-4.84|||ANCOVA|||||-4.84||0.0084
74069683|NCT00745251|147691066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.05|STANDARD_ERROR_OF_MEAN|1.64||0.0006|TWO_SIDED|95.0|-9.37|-2.74|||ANCOVA|||||-2.74|-9.37|0.0006
74069684|NCT02928848|147691067|OTHER|||||||0.14||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Repeated-measures analysis of variance (RM-ANOVA) with Condition (active, sham) and time point (baseline, 0-week) as within-subject factors. Analysis tests whether active vs. sham stimulation confers a greater improvement in overall language ability, as measured by the Western Aphasia Battery Aphasia Quotient (WAB-AQ), that endures over time.||||0.14
74069685|NCT02928848|147691068|OTHER|||||||0.02||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Repeated-measures analysis of variance (RM-ANOVA) with Condition (active, sham) and time point (baseline, 0-weeks) as within-subject factors. Analysis tests whether active vs. sham stimulation confers a greater improvement in naming ability, as measured by the naming subtest of the WAB, that endures over time.||||.02
74069686|NCT01200394|147691069|SUPERIORITY||Geometric Mean Ratio|0.843||||0.9889|TWO_SIDED|95.0|0.728|0.975||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than 0% reduction in UACR compared to placebo.|ANCOVA||Geometric mean ratio and corresponding 95% credible intervals were calculated.|Analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic blood pressure (BP) as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.||0.975|0.728|0.9889
74069687|NCT01200394|147691069|SUPERIORITY|||||||0.2402|TWO_SIDED|||||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than or equal to 20% reduction in UACR compared to placebo.|ANCOVA|||ANCOVA model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic BP as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.||||0.2402
74069688|NCT01200394|147691070|SUPERIORITY||Geometric Mean Ratio|0.8759||||0.0382|TWO_SIDED|95.0|0.7727|0.9927|||Mixed Models Analysis|||Week 3: Mixed model repeated measures (MMRM) on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9927|0.7727|0.0382
74069689|NCT01200394|147691070|SUPERIORITY||Geometric Mean Ratio|0.8311||||0.0112|TWO_SIDED|95.0|0.7208|0.9584|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9584|0.7208|0.0112
74069690|NCT01200394|147691070|SUPERIORITY||Geometric Mean Ratio|0.8816||||0.149|TWO_SIDED|95.0|0.7427|1.0465|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0465|0.7427|0.1490
73888336|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|190.9|||<|0.0001|TWO_SIDED|95.0|102.1|279.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||279.8|102.1|<0.0001
74069691|NCT01200394|147691071|SUPERIORITY||Geometric Mean Ratio|0.8565||||0.0297|TWO_SIDED|95.0|0.745|0.9847|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9847|0.7450|0.0297
73883427|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.458|||<|0.0001|TWO_SIDED|95.0|2.469|4.446|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.446|2.469|<.0001
74069692|NCT01200394|147691071|SUPERIORITY||Geometric Mean Ratio|0.8524||||0.0305|TWO_SIDED|95.0|0.7376|0.985|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9850|0.7376|0.0305
74069693|NCT01200394|147691071|SUPERIORITY||Geometric Mean Ratio|0.7937||||0.0068|TWO_SIDED|95.0|0.6717|0.9378|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9378|0.6717|0.0068
74069694|NCT01200394|147691071|SUPERIORITY||Geometric Mean Ratio|0.8634||||0.1151|TWO_SIDED|95.0|0.719|1.0368|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0368|0.7190|0.1151
74069695|NCT01200394|147691072|SUPERIORITY||Geometric Mean Ratio|0.9816||||0.3585|TWO_SIDED|95.0|0.9434|1.0214|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0214|0.9434|0.3585
74069696|NCT01200394|147691072|SUPERIORITY||Geometric Mean Ratio|0.9939||||0.7475|TWO_SIDED|95.0|0.9577|1.0315|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0315|0.9577|0.7475
74069697|NCT01200394|147691072|SUPERIORITY||Geometric Mean Ratio|0.9866||||0.4972|TWO_SIDED|95.0|0.9488|1.0259|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0259|0.9488|0.4972
74069698|NCT01200394|147691072|SUPERIORITY||Geometric Mean Ratio|1.0024||||0.9146|TWO_SIDED|95.0|0.9588|1.0481|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0481|0.9588|0.9146
74069699|NCT01200394|147691073|SUPERIORITY||Least Squares (LS) Mean Difference|-5.39|STANDARD_ERROR_OF_MEAN|1.2942|<|0.0001|TWO_SIDED|95.0|-7.94|-2.84|||Mixed Models Analysis|||Supine Systolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.84|-7.94|<0.0001
74069700|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|-3.71|STANDARD_ERROR_OF_MEAN|0.849|<|0.0001|TWO_SIDED|95.0|-5.38|-2.04|||Mixed Models Analysis|||Supine Diastolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.04|-5.38|<0.0001
74069701|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|-4.59|STANDARD_ERROR_OF_MEAN|0.9489|<|0.0001|TWO_SIDED|95.0|-6.46|-2.72|||Mixed Models Analysis|||Supine Mean BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.72|-6.46|<0.0001
74069702|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|1.4056||0.7093|TWO_SIDED|95.0|-3.29|2.24|||Mixed Models Analysis|||Supine Systolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.24|-3.29|0.7093
74069703|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.9089||0.6564|TWO_SIDED|95.0|-1.39|2.2|||Mixed Models Analysis|||Supine Diastolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.20|-1.39|0.6564
74069704|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|1.0334||0.8763|TWO_SIDED|95.0|-2.2|1.87|||Mixed Models Analysis|||Supine Mean BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.87|-2.20|0.8763
74069705|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.4926||0.7491|TWO_SIDED|95.0|-3.42|2.46|||Mixed Models Analysis|||Supine Systolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.46|-3.42|0.7491
74069706|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.9235||0.6141|TWO_SIDED|95.0|-2.29|1.35|||Mixed Models Analysis|||Supine Diastolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.35|-2.29|0.6141
74069707|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|1.0582||0.5281|TWO_SIDED|95.0|-2.75|1.42|||Mixed Models Analysis|||Supine Mean BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.42|-2.75|0.5281
74069708|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.8764||0.6695|TWO_SIDED|95.0|-2.9|4.5|||Mixed Models Analysis|||Supine Systolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||4.50|-2.90|0.6695
74069709|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.073||0.5607|TWO_SIDED|95.0|-2.74|1.49|||Mixed Models Analysis|||Supine Diastolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.49|-2.74|0.5607
74069710|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|1.2722||0.8297|TWO_SIDED|95.0|-2.78|2.23|||Mixed Models Analysis|||Supine Mean BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.23|-2.78|0.8297
74069711|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.7065||0.7644|TWO_SIDED|95.0|-2.85|3.87|||Mixed Models Analysis|||Supine Systolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||3.87|-2.85|0.7644
74069712|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.9917||0.5123|TWO_SIDED|95.0|-1.3|2.61|||Mixed Models Analysis|||Supine Diastolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.61|-1.30|0.5123
74069713|NCT01200394|147691073|SUPERIORITY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|1.1355||0.6838|TWO_SIDED|95.0|-1.77|2.7|||Mixed Models Analysis|||Supine Mean BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.70|-1.77|0.6838
74069714|NCT01200394|147691075|SUPERIORITY||Geometric Mean Ratio|0.9282||||0.5422|TWO_SIDED|95.0|0.7297|1.1807|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.1807|0.7297|0.5422
74069715|NCT01200394|147691075|SUPERIORITY||Geometric Mean Ratio|0.7998||||0.049|TWO_SIDED|95.0|0.6402|0.999|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9990|0.6402|0.0490
73883428|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.48|||<|0.0001|TWO_SIDED|95.0|2.455|4.505|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.505|2.455|<.0001
74069716|NCT01200394|147691075|SUPERIORITY||Geometric Mean Ratio|1.0435||||0.7264|TWO_SIDED|95.0|0.8211|1.3262|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.3262|0.8211|0.7264
74069717|NCT01200394|147691075|SUPERIORITY||Geometric Mean Ratio|1.1154||||0.3733|TWO_SIDED|95.0|0.8761|1.4201|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.4201|0.8761|0.3733
74069718|NCT00582309|147691099|NON_INFERIORITY_OR_EQUIVALENCE|Original Power Analysis: The expected differences in mean blood glucose concentration between groups are \> 30 mg/dL. Assuming two-tailed alpha of .05, a standard deviation of approximately 40, and a one-to-one allocation and no subject attrition, fifty patients per treatment group (150 total) will be sufficient to achieve 90% power for group mean comparisons allowing for multiple comparisons.|||||<|0.05|TWO_SIDED|95.0||||All results obtained by ANOVA are verified by the nonparametric Kruskal-Wallis test. Statistical significance will be judged by P-values \< 0.05.|ANOVA|||Demographic and baseline measurements are reported as either means and standard deviations or as frequency and percentages. These and the outcome measures are compared among the three groups by 1-way analysis of variance (ANOVA) for means or by Fisher's Exact test for frequencies as appropriate. If there is an overall significant difference, the post hoc multiple comparisons will be done by Fisher's least significant difference method.||||<0.05
74069719|NCT01463683|147691102|NON_INFERIORITY_OR_EQUIVALENCE|Incidence of seroprotection with V232-2XP SC is non-inferior to V232-1XP SC if the lower bound of the 95% confidence interval of the difference is greater than -10%|Difference in percentage of participants|7.6|||||TWO_SIDED|95.0|1.9|13.6|||Miettinen & Nurminen|||||13.6|1.9|
74069720|NCT01463683|147691103|SUPERIORITY_OR_OTHER||Difference in percentage of participants|4.9||||0.162|TWO_SIDED|95.0|-2.0|11.9|||Miettinen & Nurminen|||||11.9|-2.0|0.162
74069721|NCT01463683|147691103|SUPERIORITY_OR_OTHER||Difference in percentage of participants|11.0||||0.028|TWO_SIDED|95.0|1.1|21.6|||Miettinen & Nurminen|||||21.6|1.1|0.028
74069722|NCT01463683|147691103|SUPERIORITY_OR_OTHER||Difference in percentage of participants|6.0||||0.246|TWO_SIDED|95.0|-4.0|16.8|||Miettinen & Nurminen|||||16.8|-4.0|0.246
74069723|NCT01463683|147691104|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.7||||0.659|TWO_SIDED|95.0|-3.8|2.4|||Miettinen & Nurminen|||||2.4|-3.8|0.659
74069724|NCT01463683|147691104|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-1.6||||0.459|TWO_SIDED|95.0|-7.7|2.2|||Miettinen & Nurminen|||||2.2|-7.7|0.459
74069725|NCT01463683|147691104|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.686|TWO_SIDED|95.0|-7.1|3.0|||Miettinen & Nurminen|||||3.0|-7.1|0.686
74069726|NCT01618305|147691105|SUPERIORITY|P-value was calculated using a Cochran-Mantel-Haenszel test, stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks)||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
74069727|NCT01618305|147691106|SUPERIORITY|||||||0.557|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks)||||||0.557
74069728|NCT01618305|147691107|SUPERIORITY|||||||0.909|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||0.909
74069729|NCT01618305|147691108|SUPERIORITY|||||||0.938|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by maternal gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||0.938
74069730|NCT01618305|147691109|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||<0.001
74069731|NCT01618305|147691110|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||<0.001
74069732|NCT01618305|147691115|SUPERIORITY|||||||0.623|||||||Fisher Exact|||||||0.623
74069733|NCT01618305|147691116|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||.63
74069734|NCT01618305|147691117|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||.54
74069735|NCT01618305|147691118|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
74069736|NCT01618305|147691119|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
74069737|NCT01618305|147691120|SUPERIORITY|||||||0.064|||||||Fisher Exact|||The proportion of HIV-infected infants among those who had a determinable HIV-infection status was compared between arms.||||0.064
74069738|NCT04345471|147691129|SUPERIORITY|To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.|LS mean difference|-0.6||||0.509|TWO_SIDED|95.0|-2.5|1.2||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||1.2|-2.5|0.509
74069739|NCT04345471|147691129|SUPERIORITY|To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.|LS mean difference|-1.4||||0.131|TWO_SIDED|95.0|-3.3|0.4||A priori threshold for statistical significance is p\<0.05, 2-sided. The value was based on the post-hoc analysis by not taking into account the multiplicity.|MMRM|||||0.4|-3.3|0.131
74069740|NCT04345471|147691131|SUPERIORITY||LS mean difference|-0.2||||0.811|TWO_SIDED|95.0|-1.5|1.2||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||1.2|-1.5|0.811
74069741|NCT04345471|147691131|SUPERIORITY||LS mean difference|-0.5||||0.424|TWO_SIDED|95.0|-1.9|0.8||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||0.8|-1.9|0.424
74069742|NCT00717977|147691158|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||0.009
74069743|NCT00717977|147691159|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||0.04
74069744|NCT00717977|147691160|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Adjusted for device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||<0.001
74069745|NCT01075763|147691231|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.64
74069746|NCT01075763|147691231|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.92
74069747|NCT01075763|147691232|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.63
74069748|NCT01075763|147691232|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.74
74069749|NCT01075763|147691233|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.45
73883429|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.521|||<|0.0001|TWO_SIDED|95.0|2.422|4.62|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.620|2.422|<.0001
73883430|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.543|||<|0.0001|TWO_SIDED|95.0|2.399|4.687|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.687|2.399|<.0001
74069750|NCT01075763|147691233|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.88
74069751|NCT01075763|147691233|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.68
74069752|NCT01075763|147691233|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.81
74069753|NCT01075763|147691234|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.29
74069754|NCT01075763|147691234|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.36
74069755|NCT01075763|147691234|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.68
74069756|NCT01075763|147691234|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.41
74069757|NCT01075763|147691235|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.86
74069758|NCT01075763|147691235|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.62
74069759|NCT01075763|147691235|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.21
74069760|NCT01075763|147691236|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.95
74069761|NCT01075763|147691236|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.73
74069762|NCT01075763|147691236|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.30
74069763|NCT01075763|147691238|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.80
74069764|NCT01075763|147691238|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.74
74069765|NCT01075763|147691238|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.12
74069766|NCT01075763|147691239|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.53
74069767|NCT01075763|147691239|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.85
73888337|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|138.9||||0.0023|TWO_SIDED|95.0|50.3|227.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.6|50.3|0.0023
74069768|NCT01075763|147691239|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.85
74069769|NCT00586521|147691240|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was analyzed by paired t-test and Wilcoxon test (number of joint bleeds prophylaxis treatment compared to number of joint bleeds on-demand treatment) at 6 months of treatment.||||<0.001
74069770|NCT00586521|147691240|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||The maximum individual reduction in the actual number of joint bleeds after the switch to prophylactic treatment was analyzed by a paired t-test of the individual difference between prophylaxis treatment bleed compared to on-demand treatment bleeds.||||<0.001
74069771|NCT00586521|147691241|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||paired t-test (prophylaxis compared to on-demand) at 6 months of treatment.||||<0.001
74069772|NCT00586521|147691242|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||The Gilbert Score was the sum of 3 scores: pain (0=no pain to 3=severe pain); bleeding score (0=none to 3=3 or more major bleeds or 7 or more minor bleeds); and physical score (based on swelling, muscle atrophy; and axial deformity (at knee or ankle), range of motion, crepitus on motion, flexion contracture, instability.||||<0.001
74069773|NCT00586521|147691243|SUPERIORITY_OR_OTHER|||||||0.314||||||The alpha level for a significant P-value was pre-defined at 5%.|paired t-test|||"The Haemo-QoL A questionnaire measures the subject's self-assessment of disease impact on physical functioning, role functioning, worry, consequences, positive affect, and treatment concern."||||0.314
74069774|NCT02261428|147691244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.95|||<|0.05|TWO_SIDED|95.0|1.79|8.73|||Wilcoxon (Mann-Whitney)|||||8.73|1.79|<0.05
74069775|NCT01095003|147691258|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0426|TWO_SIDED|95.0|0.71|0.99|||Log Rank|||The final analysis of progression free survival was conducted once the required number of events(615 progressions or deaths) was reached.using the IRC assessment of date of progressions following the blinded radiological and clinical review of data. Kaplan-Meier curves and life tables by treatment arm were provided.A stratified Cox proportional model was used to compare the two treatment arms||0.99|0.71|0.0426
74069776|NCT01095003|147691259|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.7657|TWO_SIDED|95.0|0.83|1.15|||Log Rank|||||1.15|0.83|0.7657
74069777|NCT01095003|147691260|SUPERIORITY|||||||0.103|||||||Cochran-Mantel-Haenszel|||||||0.103
74069778|NCT01095003|147691261|SUPERIORITY|||||||0.0089|||||||Cochran-Mantel-Haenszel|||||||0.0089
74069779|NCT02396381|147691305|OTHER||LS Mean Difference|3.09|||<|0.001|TWO_SIDED|96.875|1.1|5.09|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of HDL-C for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC \> 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||5.09|1.10|<0.001
74069780|NCT02396381|147691306|SUPERIORITY||LS Mean Difference|-0.42||||0.001|TWO_SIDED|96.875|-0.717|-0.123|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of WBC for THS-use is lower than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≥ 0.0~HA: XTHS - XCC \< 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||-0.123|-0.717|0.001
73883431|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.584|||<|0.0001||95.0|2.354|4.814|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)||4.814|2.354|<.0001
74069781|NCT02396381|147691307|SUPERIORITY||LS Mean Difference|1.28||||0.008|TWO_SIDED|96.875|0.145|2.42|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of FEV1 for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC \> 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||2.42|0.145|0.008
74069782|NCT02396381|147691308|SUPERIORITY||% Reduction|2.86||||0.03|TWO_SIDED|96.875|-0.426|6.04|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of sICAM-1 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||6.04|-0.426|0.030
74069783|NCT02396381|147691309|SUPERIORITY||% Reduction|4.74||||0.193|TWO_SIDED|96.875|-7.5|15.6|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of 11-DTX-B2 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||15.6|-7.5|0.193
74069784|NCT02396381|147691310|SUPERIORITY||% Reduction|6.8||||0.018|TWO_SIDED|96.875|-0.216|13.3|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of 8-epi-PGF2α will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||13.3|-0.216|0.018
74069785|NCT02396381|147691311|SUPERIORITY||% Reduction|43.5|||<|0.001|TWO_SIDED|96.875|33.7|51.9|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of Total NNAL will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||51.9|33.7|<0.001
74069786|NCT02396381|147691312|SUPERIORITY||% Reduction|32.2|||<|0.001|TWO_SIDED|96.875|24.5|39.0|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis will test if the mean level of COHb for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||39|24.5|<0.001
74069787|NCT03197064|147691313|OTHER|||||||0.35|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.35
74069788|NCT03197064|147691313|OTHER|||||||0.47|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.47
74069789|NCT03197064|147691313|OTHER|||||||0.066|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.066
74069790|NCT03197064|147691314|OTHER|||||||0.72|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.72
74069791|NCT03197064|147691314|OTHER|||||||0.72|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.72
74069792|NCT03197064|147691314|OTHER|||||||0.78|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.78
74069793|NCT03197064|147691315|OTHER|||||||0.93|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.93
74069794|NCT03197064|147691315|OTHER|||||||0.39|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.39
74069795|NCT03197064|147691315|OTHER|||||||0.08|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.08
74069796|NCT03197064|147691316|OTHER|||||||0.42|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.42
74069797|NCT03197064|147691316|OTHER|||||||0.37|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.37
74069798|NCT03197064|147691316|OTHER|||||||0.49|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.49
74069799|NCT03197064|147691317|OTHER|||||||0.386|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.386
74069800|NCT03197064|147691317|OTHER|||||||0.388|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.388
74069801|NCT03197064|147691317|OTHER|||||||0.247|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.247
74069802|NCT02456532|147691320|OTHER|analyses of variance comparing the three treatment gropus|||||=|0.05|||||||ANOVA|||||||=0.05
74069803|NCT02456532|147691321|OTHER|ANOVA|||||=|0.643|||||||ANOVA|||||||=0.643
74069804|NCT02173704|147691324|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|100.0|||||TWO_SIDED|95.0|97.2|100.0|||Exact test of binomial proportion|||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the primary objective for strain 5/99 was 99%.||100|97.2|
74069805|NCT02173704|147691324|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥ 1:5 should be ≥ 70%.|single binomial proportion|79.0|||||TWO_SIDED|95.0|71.4|85.8|||Exact test of binomial proportion|||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the primary objective for strain NZ98/25 was 94%.||85.8|71.4|
74069806|NCT02173704|147691326|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|99.0|||||TWO_SIDED|95.0|95.7|99.98|||Exact test of binomial proportion|||Statistical analysis H44/76 strain: The null hypothesis associated with the primary objective is that the proportion of subjects with hSBA titers ≥ 1:5 one month after the third dose of the Bexsero® vaccine was ≤ 0.70. Assuming the results for the three strains are independent, the power to reject the null hypothesis associated with the primary objectives to demonstrate sufficiency of response (for all three strains was 92%.||99.98|95.7|
74069807|NCT02173704|147691326|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|99.0|||||TWO_SIDED|95.0|94.7|99.82|||Exact test for binomial proportion|||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the secondary objective for strain 5/99 was 99%.||99.82|94.7|
74069808|NCT02173704|147691326|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|94.0|||||TWO_SIDED|95.0|88.7|97.4|||Exact test for binomial proportions|||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the secondary objective for strain NZ98/254 was 99%.||97.4|88.7|
74069809|NCT00729859|147691356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.0075||0.28|TWO_SIDED|95.0|0.005|0.035|||paired t-test|||p value for the difference = 0.28||0.035|0.005|0.28
74069810|NCT01111110|147691366|SUPERIORITY_OR_OTHER_LEGACY||half the mean difference|21.0|STANDARD_ERROR_OF_MEAN|6.7||0.026|TWO_SIDED|95.0|3.8|41.7|||t-test, 2 sided|two sample effect size must be halved to account for mean difference estimates twice the effect size|See 4 Puff result|(Comparison of period 2 minus period 1) results Point and interval estimates are halved because this estimates twice the effect size.||41.7|3.8|0.026
74069811|NCT01111110|147691367|SUPERIORITY_OR_OTHER_LEGACY||half the mean difference|23.5|STANDARD_ERROR_OF_MEAN|6.8||0.018|TWO_SIDED|95.0|6.0|41.0||The effect size is half the difference between the means as (A-B)-(B-A)=2A-2B|t-test, 2 sided|Must take half the mean difference to estimate effect size|No comments|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.||41.0|6.0|0.018
73883432|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.606|||<|0.0001|TWO_SIDED|95.0|2.326|4.887|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.887|2.326|<.0001
74069812|NCT01111110|147691368|SUPERIORITY_OR_OTHER_LEGACY||Effect size=half the mean diff|24.7|STANDARD_ERROR_OF_MEAN|6.6||0.013|TWO_SIDED|95.0|7.7|41.7|||t-test, 2 sided||You kicked this out on another trial, but note that the period 2-Period 1 differences between the orderings estimate twice the effect size. The effect sizes herein take this into account.|Null hypothesis is that the Treatment order is independent of the dependent variable based on Period 2 minus Period 1||41.7|7.7|0.013
74069813|NCT03267264|147691494|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|17.5|||||TWO_SIDED|95.0|10.3|24.7||||||||24.7|10.3|
74069814|NCT03267264|147691495|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|30.5|||||TWO_SIDED|95.0|16.8|44.3||||||||44.3|16.8|
74069815|NCT03267264|147691495|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall|20.6|||||TWO_SIDED|95.0|4.1|37.1||||||||37.1|4.1|
74069816|NCT03267264|147691495|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|overal mean|6.2|||||TWO_SIDED|95.0|-7.2|19.5||||||||19.5|-7.2|
74069817|NCT03267264|147691495|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.8|||||TWO_SIDED|95.0|-1.1|26.7||||||||26.7|-1.1|
74069818|NCT03267264|147691496|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall mean|18.0|||||TWO_SIDED|95.0|11.3|24.7||||||Overall Comfort||24.7|11.3|
74069819|NCT03267264|147691496|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.9|||||TWO_SIDED|95.0|9.9|21.8||||||Anxiety Associated with a Needle Stick Injury||21.8|9.9|
74069820|NCT03267264|147691496|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.5|||||TWO_SIDED|95.0|8.9|22.1||||||Injection Pain||22.1|8.9|
74069821|NCT03267264|147691496|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|19.7|||||TWO_SIDED|95.0|13.8|25.7||||||Ease of Use||25.7|13.8|
74069822|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|27.8|||||TWO_SIDED|95.0|14.9|40.7||||||Overall Comfort||40.7|14.9|
74069823|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||TWO_SIDED|95.0|8.9|31.6||||||Anxiety Associated with a needle stick injury||31.6|8.9|
73883433|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.647|||<|0.0001|TWO_SIDED|95.0|2.272|5.022|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.022|2.272|<.0001
74069824|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|16.1|||||TWO_SIDED|95.0|3.4|28.8||||||Injection Pain||28.8|3.4|
73883434|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.669|||<|0.0001|TWO_SIDED|95.0|2.24|5.099|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.099|2.240|<.0001
73883435|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.71|||<|0.0001|TWO_SIDED|95.0|2.18|5.24|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.240|2.180|<.0001
73883436|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.733|||<|0.0001|TWO_SIDED|95.0|2.145|5.32|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.320|2.145|<.0001
74069825|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|30.7|||||TWO_SIDED|95.0|19.3|42.1||||||Ease of Use||42.1|19.3|
74069826|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.7|||||TWO_SIDED|95.0|5.3|36.1||||||Overall Comfort||36.1|5.3|
74069827|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|19.4|||||TWO_SIDED|95.0|6.0|32.8||||||Anxiety Associated with a needle stick||32.8|6|
74069828|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|18.6|||||TWO_SIDED|95.0|3.6|33.7||||||Injection Pain||33.7|3.6|
74069829|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|18.4|||||TWO_SIDED|95.0|4.9|31.9||||||Ease of Use||31.9|4.9|
74069830|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|8.4|||||TWO_SIDED|95.0|-4.0|20.9||||||Overall Comfort||20.9|-4.0|
74069831|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.9|||||TWO_SIDED|95.0|1.9|23.8||||||Anxiety Associated with a Needle stick injury||23.8|1.9|
74069832|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|7.0|||||TWO_SIDED|95.0|-5.3|19.4||||||Injection Pain||19.4|-5.3|
74069833|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|17.7|||||TWO_SIDED|95.0|6.7|28.8||||||Ease of Use||28.8|6.7|
74069834|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.1|||||TWO_SIDED|95.0|2.1|28.1||||||Overall Comfort||28.1|2.1|
74069835|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|11.0|||||TWO_SIDED|95.0|-0.5|22.4||||||Anxiety Associated with a Needle Stick Injury||22.4|-0.5|
74069836|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||TWO_SIDED|95.0|7.4|33.1||||||Injection Pain||33.1|7.4|
74069837|NCT03267264|147691497|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.0|||||TWO_SIDED|95.0|0.5|23.5||||||Eae of Use||23.5|0.5|
74069838|NCT01915732|147691505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.002|TWO_SIDED|95.0|-7.4|-1.6|||ANCOVA|||||-1.6|-7.4|0.002
74069839|NCT01915732|147691506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||ANCOVA|||||-1.9|-7.3|<0.001
74069840|NCT01915732|147691507|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|||||||0.018
74069841|NCT01915732|147691508|SUPERIORITY_OR_OTHER|||||||0.013|||||||Cochran-Mantel-Haenszel|||||||0.013
74069842|NCT01915732|147691509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.077|TWO_SIDED|95.0|-1.8|0.1|||ANCOVA||Statistical data for the category=IL.|||0.1|-1.8|0.077
74069843|NCT01915732|147691509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.004|TWO_SIDED|95.0|-5.7|-1.1|||ANCOVA||Statistical data for the category=NIL.|||-1.1|-5.7|0.004
74069844|NCT01915732|147691510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.028|TWO_SIDED|95.0|-2.0|-0.1|||ANCOVA||Statistical data for the category=IL.|||-0.1|-2.0|0.028
74069845|NCT01915732|147691510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.002|TWO_SIDED|95.0|-5.5|-1.2|||ANCOVA||Statistical data for the category=NIL.|||-1.2|-5.5|0.002
74069846|NCT01915732|147691511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.08|TWO_SIDED|95.0|-0.06|0.0|||ANCOVA||Statistical data for the category=IL.|||0.00|-0.06|0.080
74069847|NCT01915732|147691511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.004|TWO_SIDED|95.0|-0.12|-0.02|||ANCOVA||Statistical data for the category=NIL.|||-0.02|-0.12|0.004
74069848|NCT01915732|147691511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.003|TWO_SIDED|95.0|-0.09|-0.02|||ANCOVA||Statisticial data for the category=Total.|||-0.02|-0.09|0.003
74069849|NCT01915732|147691512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.025|TWO_SIDED|95.0|-0.07|0.0|||ANCOVA||Statistical data for the category=IL.|||-0.00|-0.07|0.025
74069850|NCT01915732|147691512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|||<|0.001|TWO_SIDED|95.0|-0.14|-0.04|||ANCOVA||Statistical data for the category=NIL.|||-0.04|-0.14|<0.001
74069851|NCT01915732|147691512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||<|0.001|TWO_SIDED|95.0|-0.1|-0.03|||ANCOVA||Statistical data for the category=Total.|||-0.03|-0.10|<0.001
74069852|NCT01915732|147691513|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74069853|NCT01915732|147691514|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
74069854|NCT01569451|147691519|SUPERIORITY_OR_OTHER|||||||0.0493|||||||Chi-squared|||||||0.0493
74069855|NCT01569451|147691520|SUPERIORITY_OR_OTHER|||||||0.0268|||||||Peto|||||||0.0268
74069856|NCT01569451|147691521|SUPERIORITY_OR_OTHER|||||||0.0189|||||||Chi-squared|||||||0.0189
74069857|NCT01569451|147691522|SUPERIORITY_OR_OTHER|||||||0.3167|||||||Chi-squared|||||||0.3167
74069858|NCT01569451|147691523|SUPERIORITY_OR_OTHER|||||||0.094|||||||Chi-squared|||||||0.0940
74069859|NCT01569451|147691524|SUPERIORITY_OR_OTHER|||||||0.3507|||||||Fisher Exact|||||||0.3507
74069860|NCT01569451|147691525|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
74069861|NCT01569451|147691526|SUPERIORITY_OR_OTHER|||||||0.4904|||||||t-test, 2 sided|||T-test||||0.4904
74069862|NCT01569451|147691527|SUPERIORITY_OR_OTHER|||||||0.4073|||||||Chi-squared|||||||0.4073
74069863|NCT01569451|147691528|SUPERIORITY_OR_OTHER|||||||0.8677|||||||Mixed Models Analysis|||||||0.8677
74069864|NCT01569451|147691529|OTHER|Mean difference between treatment groups.||||||0.3974|||||||t-test, 2 sided|||||||0.3974
74069865|NCT01656889|147691574|SUPERIORITY_OR_OTHER|||||||0.5896|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value is based on the chi-squared proportion of wounds closed in each group.||||||0.5896
74069866|NCT01656889|147691575|SUPERIORITY_OR_OTHER|||||||0.3675|TWO_SIDED|0.0|||||Regression, Cox|||||||.3675
74069867|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.6426|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 01||||0.6426
74069868|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.3843|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 02||||.3843
74069869|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.2792|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 03||||0.2792
74069870|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.1502|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 04||||0.1502
74069871|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.3823|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 05||||0.3823
74069872|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.5528|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 06||||0.5528
74069873|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.02913|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 07||||.02913
74069874|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.3896|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 08||||0.3896
74069875|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.3989|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 09||||0.3989
74069876|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.8682|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 10||||0.8682
74069877|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.8083|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 11||||0.8083
74069878|NCT01656889|147691576|SUPERIORITY_OR_OTHER|||||||0.6687|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 12||||0.6687
74069879|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.3601|TWO_SIDED||||||ANCOVA|||Week 01||||0.3601
74069880|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.9398|TWO_SIDED||||||ANCOVA|||Week 02||||0.9398
74069881|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED||||||ANCOVA|||Week 03||||0.905
74069882|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.4471|TWO_SIDED||||||ANCOVA|||Week 04||||0.4471
74069883|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.3004|TWO_SIDED||||||ANCOVA|||Week 05||||0.3004
74069884|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.1815|TWO_SIDED||||||ANCOVA|||Week 06||||0.1815
74069885|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||ANCOVA|||Week 07||||0.399
74069886|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.8027|TWO_SIDED||||||ANCOVA|||Week 08||||0.8027
74069887|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.4913|TWO_SIDED||||||ANCOVA|||Week 09||||0.4913
74069888|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.5227|TWO_SIDED||||||ANCOVA|||Week 10||||0.5227
74069889|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.7032|TWO_SIDED||||||ANCOVA|||Week 11||||0.7032
74069890|NCT01656889|147691578|SUPERIORITY_OR_OTHER|||||||0.9366|TWO_SIDED||||||ANCOVA|||||||0.9366
74069891|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.9853|TWO_SIDED||||||ANCOVA|||Week 01||||0.9853
74069892|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.7083|TWO_SIDED||||||ANCOVA|||Week 02||||0.7083
74069893|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.6744|TWO_SIDED||||||ANCOVA|||Week 03||||0.6744
74069894|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.2891|TWO_SIDED||||||ANCOVA|||||||0.2891
74069895|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.9923|TWO_SIDED||||||ANCOVA|||Week 05||||0.9923
74069896|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.1775|TWO_SIDED||||||ANCOVA|||Week 06||||0.1775
74069897|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED||||||ANCOVA|||Week 07||||0.499
74069898|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.4423|TWO_SIDED||||||ANCOVA|||Week 08||||0.4423
74069899|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.5138|TWO_SIDED||||||ANCOVA|||Week 09||||0.5138
74069900|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.3409|TWO_SIDED||||||ANCOVA|||Week 10||||0.3409
74069901|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.6358|TWO_SIDED||||||ANCOVA|||Week 11||||0.6358
74069902|NCT01656889|147691579|SUPERIORITY_OR_OTHER|||||||0.6753|TWO_SIDED||||||ANCOVA|||Week 12||||0.6753
74069903|NCT01656889|147691580|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier Survival analysis|||||||< 0.05
74069904|NCT00814320|147691601|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.025|||<|0.0001|ONE_SIDED|99.0||0.046||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson|||For SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only||0.046||<0.0001
74069905|NCT00491504|147691667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625|||||||ANCOVA|An analysis of covariance (ANCOVA) model was used with treatment as effect and Baseline as a covariate.||||||0.625
74069906|NCT02114307|147691670|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74069907|NCT02114307|147691671|SUPERIORITY|||||||0.0023|||||||t-test, 2 sided|||Sham Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation||||0.0023
74069908|NCT02114307|147691671|SUPERIORITY|||||||0.0815|||||||t-test, 2 sided|||Test Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation||||0.0815
74069909|NCT02114307|147691672|SUPERIORITY|||||||0.127|||||||t-test, 1 sided|||||||0.127
74069910|NCT02041702|147691673|SUPERIORITY|The 2-sided 90% confidence interval (CI) was calculated using the Clopper-Pearson method.|Ratio|100.0|||<|0.01|TWO_SIDED|90.0|97.6|100.0|||Clopper-Pearson|Clopper-Pearson CI for the binomial proportion|The null hypothesis would be rejected if the lower bound of the 2-sided 90% confidence interval was greater than 90%.|The hypothesis was: H0: P≤ 90% vs H1: P\>90% P: The proportion of subjects free from MRI scan related complications at 1 month post MRI scan in cardiac MRI scan group||100|97.6|<0.01
74069911|NCT02041702|147691674|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-0.9||||0.0007|TWO_SIDED|90.0|-5.6|3.8|||Farrington-Manning Test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL\>-10%~* PMRI: the success rate in the Cardiac MRI scan group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit"||3.8|-5.6|0.0007
74069912|NCT02041702|147691675|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-1.7||||0.0012|TWO_SIDED|90.0|-6.2|2.8|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||2.8|-6.2|0.0012
74069913|NCT02041702|147691676|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-2.7||||0.0446|TWO_SIDED|90.0|-9.8|4.3|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was:H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in MRI Scan Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||4.3|-9.8|0.0446
74069914|NCT02041702|147691677|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|2.6||||0.0002|TWO_SIDED|90.0|-3.2|8.4|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||8.4|-3.2|0.0002
74069915|NCT02708277|147691724|SUPERIORITY_OR_OTHER|||||||0.009|||||||Chi-squared|||||||0.009
74069916|NCT02708277|147691725|SUPERIORITY_OR_OTHER|||||||0.303|||||||Chi-squared|||||||0.303
74069917|NCT02708277|147691726|SUPERIORITY_OR_OTHER|||||||0.606|||||||t-test, 2 sided|||||||0.606
74069918|NCT02708277|147691727|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.05
74069919|NCT02761980|147691788|SUPERIORITY||LSM difference|3.14||||0.002|TWO_SIDED|95.0|1.13|5.15|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on Least Square Mean (LSM) from analysis of covariance (ANCOVA) with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||5.15|1.13|0.002
74069920|NCT02761980|147691788|SUPERIORITY||LSM difference|0.91||||0.21|TWO_SIDED|95.0|-0.52|2.33|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||2.33|-0.52|0.210
74069921|NCT02761980|147691788|SUPERIORITY||LSM difference|0.79||||0.28|TWO_SIDED|95.0|-0.64|2.21|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||2.21|-0.64|0.280
74069922|NCT02761980|147691788|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.23||||0.03|TWO_SIDED|95.0|0.22|4.25|||ANCOVA|||||4.25|0.22|0.030
74069923|NCT02761980|147691788|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.35||||0.023|TWO_SIDED|95.0|0.33|4.37|||ANCOVA|||||4.37|0.33|0.023
74069924|NCT02761980|147691788|SUPERIORITY||LSM difference|-0.12||||0.864|TWO_SIDED|95.0|-1.54|1.29|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||1.29|-1.54|0.864
74069925|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.9||||0.004|TWO_SIDED|95.0|0.29|1.51|||ANCOVA|||WSTD 0-2 hours||1.51|0.29|0.004
74069926|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.39||||0.078|TWO_SIDED|95.0|-0.04|0.82|||ANCOVA|||WSTD 0-2 hours||0.82|-0.04|0.078
74069927|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.3||||0.172|TWO_SIDED|95.0|-0.13|0.74|||ANCOVA|||WSTD 0-2 hours||0.74|-0.13|0.172
74069928|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51||||0.098|TWO_SIDED|95.0|-0.1|1.13|||ANCOVA|||WSTD 0-2 hours||1.13|-0.10|0.098
74069929|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.6||||0.054|TWO_SIDED|95.0|-0.01|1.21|||ANCOVA|||WSTD 0-2 hours||1.21|-0.01|0.054
74069930|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09||||0.692|TWO_SIDED|95.0|-0.52|0.34|||ANCOVA|||WSTD 0-2 hours||0.34|-0.52|0.692
74069931|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.87|||<|0.001|TWO_SIDED|95.0|0.86|2.88|||ANCOVA|||WSTD 0-4 hours||2.88|0.86|< 0.001
74069932|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.61||||0.094|TWO_SIDED|95.0|-0.1|1.33|||ANCOVA|||WSTD 0-4 hours||1.33|-0.10|0.094
73883437|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.773|||<|0.0001|TWO_SIDED|95.0|2.08|5.466|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.466|2.080|<.0001
74069933|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.45||||0.217|TWO_SIDED|95.0|-0.27|1.17|||ANCOVA|||WSTD 0-4 hours||1.17|-0.27|0.217
74069934|NCT02761980|147691789|SUPERIORITY||LSM difference|1.26||||0.015|TWO_SIDED|95.0|0.24|2.27||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|ANCOVA|||WSTD 0-4 hours||2.27|0.24|0.015
74069935|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.42||||0.006|TWO_SIDED|95.0|0.4|2.44|||ANCOVA|||WSTD 0-4 hours||2.44|0.40|0.006
74069936|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.16||||0.659|TWO_SIDED|95.0|-0.87|0.55|||ANCOVA|||WSTD 0-4 hours||0.55|-0.87|0.659
74069937|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.62|||<|0.001|TWO_SIDED|95.0|1.16|4.08|||ANCOVA|||WSTD 0-6 hours||4.08|1.16|< 0.001
74069938|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.79||||0.135|TWO_SIDED|95.0|-0.25|1.82|||ANCOVA|||WSTD 0-6 hours||1.82|-0.25|0.135
74069939|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.7||||0.186|TWO_SIDED|95.0|-0.34|1.74|||ANCOVA|||WSTD 0-6 hours||1.74|-0.34|0.186
74069940|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.83||||0.014|TWO_SIDED|95.0|0.37|3.29|||ANCOVA|||WSTD 0-6 hours||3.29|0.37|0.014
74069941|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.92||||0.011|TWO_SIDED|95.0|0.45|3.39|||ANCOVA|||WSTD 0-6 hours||3.39|0.45|0.011
74069942|NCT02761980|147691789|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09||||0.865|TWO_SIDED|95.0|-1.12|0.94|||ANCOVA|||WSTD 0-6 hours||0.94|-1.12|0.865
74069943|NCT02761980|147691790|SUPERIORITY|||||||0.449||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.449
74069944|NCT02761980|147691790|SUPERIORITY|||||||0.142||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.142
74069945|NCT02761980|147691790|SUPERIORITY|||||||0.822||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.822
74069946|NCT02761980|147691790|SUPERIORITY|||||||0.671||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.671
74069947|NCT02761980|147691790|SUPERIORITY|||||||0.514||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.514
74069948|NCT02761980|147691790|SUPERIORITY|||||||0.191||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.191
74069949|NCT02761980|147691791|SUPERIORITY|||||||0.997||||||P-value, hazard ratio (HR) and corresponding 95% CI were calculated based on the proportional hazards (PH) model with treatment term in the model.|hazard ratio|||||||0.997
74069950|NCT02761980|147691791|SUPERIORITY|||||||0.998||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio|||||||0.998
74069951|NCT02761980|147691791|SUPERIORITY|||||||0.997||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio|||||||0.997
74069952|NCT02761980|147691792|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.67||||0.101|TWO_SIDED|95.0|-0.13|1.48|||ANCOVA|||||1.48|-0.13|0.101
74069953|NCT02761980|147691792|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.16||||0.582|TWO_SIDED|95.0|-0.41|0.73|||ANCOVA|||||0.73|-0.41|0.582
74069954|NCT02761980|147691792|SUPERIORITY||LSM difference|0.15||||0.614|TWO_SIDED|95.0|-0.43|0.72|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||0.72|-0.43|0.614
74069955|NCT02761980|147691792|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51||||0.212|TWO_SIDED|95.0|-0.29|1.32|||ANCOVA|||||1.32|-0.29|0.212
74069956|NCT02761980|147691792|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.53||||0.202|TWO_SIDED|95.0|-0.28|1.34|||ANCOVA|||||1.34|-0.28|0.202
74069957|NCT02761980|147691792|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.01||||0.965|TWO_SIDED|95.0|-0.58|0.55|||ANCOVA|||||0.55|-0.58|0.965
74069958|NCT02708290|147691816|OTHER|Participants in the MITA group were matched to those in Control (treatment-as-usual) group using propensity score analysis based on age and all four ATEC subscales at baseline. Least squares means were calculated for all subscales at all visits.|Mean Difference (Final Values)|4.68|||<|0.0001|TWO_SIDED||||||Regression, Linear|||"The concept of a Visit was developed by dividing the three-year-long observation interval into 3-month periods. All evaluations were mapped into 3-month-long bins (Reference: Mahapatra, S. et al. Autism Dev. Disord. 2018, 1). It was then hypothesized that there was a three-way interaction between an age group, Visit, and treatment. This hypothesis was modeled by applying the Linear Model with repeated measures, where a three-way interaction term was introduced to test the hypothesis."||||<0.0001
74069959|NCT02192905|147691824|OTHER|One-sample t-test testing the mean positive problem solving change from baseline to week 8.|Mean Difference (Final Values)|-0.64|STANDARD_DEVIATION|8.31||0.63|TWO_SIDED|95.0|-3.34|2.05|||t-test, 2 sided|||||2.05|-3.34|.63
74069960|NCT02192905|147691825|OTHER|One-sample t-test testing the mean within-person percent weight change from baseline to week 8.|Mean Difference (Final Values)|-0.019|STANDARD_DEVIATION|0.03|<|0.001|TWO_SIDED|95.0|-0.0285|-0.0096|||t-test, 2 sided|||||-.0096|-.0285|<0.001
74069961|NCT02192905|147691826|OTHER|One-sample t-test testing the mean within-person percent weight change from baseline to week 16.|Mean Difference (Final Values)|-0.017|STANDARD_DEVIATION|0.011||0.143|TWO_SIDED|95.0|-0.039|0.006|||t-test, 2 sided|||||.006|-.039|0.143
74069962|NCT02192905|147691827|OTHER|One-sample t-test testing the mean positive problem solving change from baseline to week 16.|Mean Difference (Final Values)|-0.76|STANDARD_DEVIATION|13.07||0.73|TWO_SIDED|95.0|-5.11|3.6|||t-test, 2 sided|||||3.6|-5.11|.73
74069963|NCT02688400|147691861|NON_INFERIORITY|"Non-inferiority of Diacerein versus Celecoxib was assessed by computing the difference in the adjusted mean change from baseline (Visit 2) in WOMAC Pain subscale score after 182 days of treatment between Diacerein and Celecoxib treatment groups from a MMRM.~Assuming that:~* Non inferiority margin of 10 points for the absolute change in WOMAC Pain Subscale Score (scale 0-100)~* SD of 26 in the two treatment groups,~* Type I error: α = 0.025 (one-sided condition) and power equal to 90%"|Mean Difference (Final Values)|0.67|||<|0.025|ONE_SIDED|95.0||3.18||MMRM. Non-inferiority claim:Diacerein to be non-inferior to Celecoxib if upper bound of the the difference in the adjusted mean change was inferior to 5 cm on the PPS.|Mixed Models Analysis|||||3.18||<0.025
74069964|NCT02688400|147691862|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
74069965|NCT02688400|147691863|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
74069966|NCT02688400|147691864|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
74069967|NCT02688400|147691865|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
74069968|NCT02688400|147691866|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
74069969|NCT02688400|147691867|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
74069970|NCT02688400|147691868|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
74069971|NCT02688400|147691869|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
74069972|NCT02006706|147691878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|0.606|<|0.001|TWO_SIDED|95.0|1.73|4.22|||t-test, 2 sided||The null hypothesis was that there was no difference between the DAS28 at baseline and DAS28 after 24 weeks of follow-up|||4.22|1.73|<0.001
74069973|NCT02006706|147691879|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74069974|NCT00992407|147691900|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.61||||0.8595|TWO_SIDED|95.0|-7.5|6.3|||t-test, 2 sided|||Change from Baseline in Personal and Social Performance (PSP) Scale Score at Week 52||6.3|-7.5|0.8595
74069975|NCT00992407|147691901|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|1.29||||0.8118|TWO_SIDED|95.0|-9.6|12.2|||t-test, 2 sided|||Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52||12.2|-9.6|0.8118
74069976|NCT00992407|147691910|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|10.0||||0.1768|TWO_SIDED|95.0|-4.8|24.8|||Student's t-test|||Change from Baseline in Psychosocial Well-being Index (PWI) Score at Week 52||24.8|-4.8|0.1768
74069977|NCT00992407|147691911|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.33||||0.9569|TWO_SIDED|95.0|-12.8|12.2|||Student's t-test|||||12.2|-12.8|0.9569
74069978|NCT00992407|147691912|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|0.58||||0.5294|TWO_SIDED|95.0|-5.5|2.9|||t-test, 2 sided|||||2.9|-5.5|0.5294
74069979|NCT01884025|147691948|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 2 sided|t-Value: 0.55||Change in total BADS score.||||0.59
74069980|NCT01884025|147691948|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|t Value: 0.03||Change in Activation Subscale||||0.98
74069981|NCT01884025|147691948|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|"DF: 18~1 Value: -0.04"||Change in Avoidance/Rumination Subscale||||0.96
74069982|NCT01884025|147691948|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|t Value: 1.31||Change in Work/School Impairment Subscale||||0.21
74069983|NCT01884025|147691948|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|t Value: 0.99||Change in Social Impairment Subscale||||0.34
74069984|NCT01884025|147691949|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|t Value: 0.33||||||0.75
74069985|NCT01884025|147691950|SUPERIORITY_OR_OTHER|||||||0.72|||||||t-test, 2 sided|t Value: -0.36||Change in overall physical activity frequency were compared between the two groups.||||0.72
74069986|NCT01884025|147691950|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|t Value: -0.39||Change in moderate physical activity frequency between the two groups.||||0.70
74069987|NCT01884025|147691951|SUPERIORITY|||||||0.45|ONE_SIDED|95.0|||||t-test, 2 sided|t Value: 0.77||Change in the physical health scale of the RAND 12 were compared.||||0.45
74069988|NCT01884025|147691951|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|t Value: 0.76||Change in the mental health scale of the RAND 12 were compared.||||0.45
74069989|NCT01884025|147691952|SUPERIORITY_OR_OTHER|||||||0.72|||||||t-test, 2 sided|t Value: -0.36||||||0.72
74069990|NCT01884025|147691953|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|t Value: 0.15||||||0.88
74069991|NCT01884025|147691954|SUPERIORITY|||||||0.08|ONE_SIDED|95.0|||||t-test, 2 sided|t Value: 1.83||||||.08
74069992|NCT01884025|147691955|SUPERIORITY|||||||0.16||||||Chi Squared 1.98|Chi-squared|||||||.16
74069993|NCT01884025|147691956|SUPERIORITY|||||||0.85||||||t value: .19|t-test, 2 sided|||||||.85
74069994|NCT01884025|147691957|SUPERIORITY|||||||0.6||||||t value: .54|t-test, 2 sided|||||||.60
73888338|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|147.8||||0.0013|TWO_SIDED|95.0|59.0|236.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||236.7|59.0|0.0013
74069995|NCT01884025|147691958|SUPERIORITY|||||||0.26||||||t value: -1.17|t-test, 2 sided|||||||.26
74069996|NCT01884025|147691959|SUPERIORITY|||||||0.08||||||t value: 1.85|t-test, 2 sided|||||||.08
74069997|NCT00395226|147691964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.284|TWO_SIDED|95.0|-0.47|1.62||The a priori significance threshold level was 0.05 (two-sided)|ANCOVA|The ANCOVA used group as a factor and baseline rosacea severity score as a covariate.|The effect of zinc sulfate treatment on rosacea severity score was estimated with baseline rosacea severity score included in the regression model|"The null hypothesis was no group differences. The alternative hypothesis was that the zinc sulfate arm is superior to placebo arm."||1.62|-0.47|0.2840
74069998|NCT01807871|147691968|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.48
74069999|NCT01807871|147691970|SUPERIORITY|||||||0.24|||||||Chi-squared|||Comparison of number of participants who reported removing the nicotine patch due to a side effect||||0.24
74070000|NCT00585780|147691988|OTHER|Expected outcome was that Prazosin will be better than placebo in reducing HDD% among High AW individuals but no differences by medication treatment in the Low AW individuals.|Odds Ratio (OR)|0.23||||0.016|TWO_SIDED|95.0|0.1|0.55||This is for the apriori hypothesis of significant AWX Treatment X Time effect.|Mixed Models Analysis|Simple effects were conducted to assess source of the interaction.||Intent-to-treat (ITT) analyses with baseline AW severity (mean-centered continuous CIWA-Ar scores) as a moderator of Time (Pre-Full Dose(FD): weeks 1-2; Post FD: weeks 3-12) were conducted with linear or generalized linear mixed effect (LME/GLME) piecewise growth models for continuous and binary outcomes. Control variables that were modeled in all analyses. As hypothesized, significant interactions were tested using AW median cut-offs for high and Low AW groups.||0.55|0.1|0.016
74070001|NCT00585780|147691989|OTHER|Expected outcome was that Prazosin will be better than placebo in reducing percent of drinking days (DD%) among High AW individuals but no differences by medication treatment in the Low AW individuals.|Odds Ratio (OR)|0.5||||0.002|TWO_SIDED|95.0|0.28|0.92||This is for apriori hypothesized significant AW X Treatment X Post-full dose time interaction effect.|Mixed Models Analysis|||Intent-to-treat (ITT) analyses with baseline AW severity (mean-centered continuous CIWA-Ar scores) as a moderator of Time (Pre-Full Dose(FD): weeks 1-2; Post FD: weeks 3-12) were conducted with linear or generalized linear mixed effect (LME/GLME) piecewise growth models for continuous and binary outcomes. Control variables that were modeled in all analyses. As hypothesized, significant interactions were tested using AW median cut-offs for high and Low AW groups.||0.92|0.28|0.002
74070002|NCT00947427|147692006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||ANCOVA|||||||0.86
74070003|NCT00936975|147692014|SUPERIORITY_OR_OTHER||Slope|-6.6084|STANDARD_ERROR_OF_MEAN|1.7644|<|0.001|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE||GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|This was an exploratory study and no a priori assumptions were employed.||||<0.001
74070004|NCT00936975|147692015|SUPERIORITY_OR_OTHER||Slope|-0.0115|STANDARD_ERROR_OF_MEAN|0.0089||0.1945|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|the difference in Patlak flux in tumor bone between baseline and 12 weeks, accounting for the fact that each participant could contribute more than one tumor bone.||||0.1945
74070005|NCT00936975|147692016|SUPERIORITY_OR_OTHER||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.3274||0.32|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.32
74070006|NCT00936975|147692016|SUPERIORITY_OR_OTHER||Slope|6.98|STANDARD_ERROR_OF_MEAN|1.6943|<|0.001|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: No difference in uptake b/w normal \& tumor bones||||<0.001
74070007|NCT00936975|147692017|SUPERIORITY_OR_OTHER||Slope|-0.0177|STANDARD_ERROR_OF_MEAN|0.0125||0.16|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.16
74070008|NCT00936975|147692018|SUPERIORITY_OR_OTHER||Slope|0.0017|STANDARD_ERROR_OF_MEAN|0.0027||0.53|TWO_SIDED||||||Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.53
74070009|NCT00936975|147692018|SUPERIORITY_OR_OTHER||Slope|0.0205|STANDARD_ERROR_OF_MEAN|0.0128||0.1095|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: influx(Ki) is the same in normal and tumor bones||||0.1095
74070010|NCT00936975|147692019|SUPERIORITY_OR_OTHER||Slope|0.0061|STANDARD_ERROR_OF_MEAN|0.0021||0.0033|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 bones in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.0033
74070011|NCT00936975|147692019|SUPERIORITY_OR_OTHER||Slope|0.0177|STANDARD_ERROR_OF_MEAN|0.0097||0.067|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|H0: Change Patlak Flux from TP1 to TP2 is the same in normal and tumor bones||||0.0670
74070012|NCT00936975|147692019|SUPERIORITY_OR_OTHER||Slope|32.3288|STANDARD_ERROR_OF_MEAN|14.6956||0.0278|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations||Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: %Change in Patlak Flux between timepoint 1 and 2 is the same for Normal and Tumor bones||||0.0278
74070013|NCT02974153|147692042|SUPERIORITY||Mean Difference (Final Values)|-2.6|STANDARD_DEVIATION|6.15|<|0.0001|TWO_SIDED|95.0|-3.45|-1.74|||ANCOVA|||||-1.74|-3.45|<0.0001
74070014|NCT02974153|147692042|SUPERIORITY||Mean Difference (Final Values)|-2.03|STANDARD_DEVIATION|6.15|<|0.0001|TWO_SIDED|95.0|-2.88|-1.18|||ANCOVA|||||-1.18|-2.88|<0.0001
74070015|NCT02974153|147692043|SUPERIORITY||Mean Difference (Final Values)|18.1|||<|0.0001|TWO_SIDED|95.0|12.0|24.3|||Cochran-Mantel-Haenszel|||||24.3|12.0|<0.0001
74070016|NCT02974153|147692043|SUPERIORITY||Mean Difference (Final Values)|11.7||||0.0001|TWO_SIDED|95.0|5.8|17.5|||Cochran-Mantel-Haenszel|||||17.5|5.8|0.0001
74070017|NCT02974153|147692044|SUPERIORITY||Mean Difference (Final Values)|21.3|||<|0.0001|TWO_SIDED|95.0|15.0|27.6|||Cochran-Mantel-Haenszel|||||27.6|15.0|<0.0001
74070018|NCT02974153|147692044|SUPERIORITY||Mean Difference (Final Values)|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.3|<0.0001
74070019|NCT02974153|147692045|SUPERIORITY||Mean Difference (Final Values)|22.1|||<|0.0001|TWO_SIDED|95.0|14.9|29.2|||Cochran-Mantel-Haenszel|||||29.2|14.9|<0.0001
74070020|NCT02974153|147692045|SUPERIORITY||Mean Difference (Final Values)|18.2|||<|0.0001|TWO_SIDED|95.0|11.1|25.4|||Cochran-Mantel-Haenszel|||||25.4|11.1|<0.0001
74070021|NCT02974153|147692046|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74070022|NCT02974153|147692046|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74070023|NCT02974153|147692047|SUPERIORITY||Mean Difference (Final Values)|-1.38|||<|0.0001|TWO_SIDED|95.0|-1.88|-0.87|||ANCOVA|||||-0.87|-1.88|<0.0001
74070024|NCT02974153|147692047|SUPERIORITY||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.66|-0.65|||ANCOVA|||||-0.65|-1.66|<0.0001
74070025|NCT02974153|147692048|SUPERIORITY||Mean Difference (Final Values)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.91|-1.84|||ANCOVA|||||-1.84|-3.91|<0.0001
74070026|NCT02974153|147692048|SUPERIORITY||Mean Difference (Final Values)|-1.73||||0.001|TWO_SIDED|95.0|-2.76|-0.7|||ANCOVA|||||-0.70|-2.76|0.0010
74070027|NCT02974153|147692049|SUPERIORITY||Mean Difference (Final Values)|-11.0|||<|0.0001|TWO_SIDED|95.0|-14.22|-7.77|||Repeated Measures Model|||||-7.77|-14.22|<0.0001
74070028|NCT02974153|147692049|SUPERIORITY||Mean Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-11.48|-5.05|||Repeated Measures Model|||||-5.05|-11.48|<0.0001
74070029|NCT02277769|147692069|SUPERIORITY||difference in percentages|27.6|||<|0.0001|TWO_SIDED|95.0|20.46|34.69||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.69|20.46|< 0.0001
74070030|NCT02277769|147692069|SUPERIORITY||difference in percentages|27.9|||<|0.0001|TWO_SIDED|95.0|20.87|34.99||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.99|20.87|< 0.0001
74070031|NCT02277769|147692070|SUPERIORITY||difference in percentages|32.3|||<|0.0001|TWO_SIDED|95.0|24.75|39.94||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||39.94|24.75|< 0.0001
74070032|NCT02277769|147692070|SUPERIORITY||difference in percentages|36.3|||<|0.0001|TWO_SIDED|95.0|28.69|43.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||43.81|28.69|< 0.0001
74070033|NCT02277769|147692071|SUPERIORITY||difference in percentages|26.5|||<|0.0001|TWO_SIDED|95.0|19.13|33.87||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||33.87|19.13|< 0.0001
74070034|NCT02277769|147692071|SUPERIORITY||difference in percentages|29.5|||<|0.0001|TWO_SIDED|95.0|22.11|36.95||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.95|22.11|< 0.0001
74070035|NCT02277769|147692072|SUPERIORITY||difference in percentages|37.8|||<|0.0001|TWO_SIDED|95.0|30.03|45.6||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||45.60|30.03|< 0.0001
74070036|NCT02277769|147692072|SUPERIORITY||difference in percentages|36.3|||<|0.0001|TWO_SIDED|95.0|28.56|44.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||44.06|28.56|< 0.0001
74070037|NCT02277769|147692073|SUPERIORITY||LS mean difference|-28.9|||<|0.0001|TWO_SIDED|95.0|-36.04|-21.83||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.83|-36.04|< 0.0001
74070038|NCT02277769|147692073|SUPERIORITY||Least square (LS) mean difference|-32.8|||<|0.0001|TWO_SIDED|95.0|-40.2|-25.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.49|-40.20|< 0.0001
74070039|NCT02277769|147692074|SUPERIORITY||difference in percentages|16.3|||<|0.0001|TWO_SIDED|95.0|9.99|22.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||22.68|9.99|< 0.0001
73883438|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.796|||<|0.0001|TWO_SIDED|95.0|2.043|5.548|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.548|2.043|<.0001
74070040|NCT02277769|147692074|SUPERIORITY||difference in percentages|21.3|||<|0.0001|TWO_SIDED|95.0|14.66|27.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||27.93|14.66|< 0.0001
74070041|NCT02277769|147692075|SUPERIORITY||difference in percentages|9.8|||<|0.0001|TWO_SIDED|95.0|5.54|13.98||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||13.98|5.54|< 0.0001
74070042|NCT02277769|147692075|SUPERIORITY||difference in percentages|11.8|||<|0.0001|TWO_SIDED|95.0|7.31|16.32||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||16.32|7.31|< 0.0001
74070043|NCT02277769|147692076|SUPERIORITY||LS mean difference|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.605|-1.587||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.587|-2.605|< 0.0001
74070044|NCT02277769|147692076|SUPERIORITY||LS mean difference|-2.47|||<|0.0001|TWO_SIDED|95.0|-2.982|-1.957||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.957|-2.982|< 0.0001
74070045|NCT02277769|147692077|SUPERIORITY||LS mean difference|-36.2|||<|0.0001|TWO_SIDED|95.0|-43.46|-28.86|||ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-28.86|-43.46|< 0.0001
74070046|NCT02277769|147692077|SUPERIORITY||LS mean difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-45.55|-30.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.88|-45.55|< 0.0001
74070047|NCT02277769|147692078|SUPERIORITY||difference in percentages|43.2|||<|0.0001|TWO_SIDED|95.0|35.12|51.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||51.29|35.12|< 0.0001
74070048|NCT02277769|147692078|SUPERIORITY||difference in percentages|39.1|||<|0.0001|TWO_SIDED|95.0|30.92|47.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||47.19|30.92|< 0.0001
74070049|NCT02277769|147692079|SUPERIORITY||difference in percentages|22.8|||<|0.0001|TWO_SIDED|95.0|16.09|29.59||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||29.59|16.09|< 0.0001
74070050|NCT02277769|147692079|SUPERIORITY||difference in percentages|23.3|||<|0.0001|TWO_SIDED|95.0|16.63|30.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||30.05|16.63|< 0.0001
74070051|NCT02277769|147692080|SUPERIORITY||LS mean difference|-17.99|||<|0.0001|TWO_SIDED|95.0|-22.062|-13.927||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.927|-22.062|< 0.0001
74070052|NCT02277769|147692080|SUPERIORITY||LS mean difference|-19.51|||<|0.0001|TWO_SIDED|95.0|-23.491|-15.529||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-15.529|-23.491|< 0.0001
74070053|NCT02277769|147692081|SUPERIORITY||LS mean difference|-31.4|||<|0.0001|TWO_SIDED|95.0|-37.36|-25.4||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.40|-37.36|< 0.0001
74070054|NCT02277769|147692081|SUPERIORITY||LS mean difference|-33.8|||<|0.0001|TWO_SIDED|95.0|-39.75|-27.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-27.80|-39.75|< 0.0001
74070055|NCT02277769|147692082|SUPERIORITY||LS mean difference|-5.7|||<|0.0001|TWO_SIDED|95.0|-6.86|-4.47||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.47|-6.86|< 0.0001
74070056|NCT02277769|147692082|SUPERIORITY||LS mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.1|-4.72||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.72|-7.10|< 0.0001
74070057|NCT02277769|147692083|SUPERIORITY||LS mean difference|-7.0|||<|0.0001|TWO_SIDED|95.0|-8.36|-5.57||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-5.57|-8.36|< 0.0001
74070058|NCT02277769|147692083|SUPERIORITY||LS mean difference|-8.0|||<|0.0001|TWO_SIDED|95.0|-9.36|-6.64||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.64|-9.36|< 0.0001
74070059|NCT02277769|147692084|SUPERIORITY||LS mean difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.34|-3.09||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-3.09|-5.34|< 0.0001
74070060|NCT02277769|147692084|SUPERIORITY||LS mean difference|-4.9|||<|0.0001|TWO_SIDED|95.0|-6.04|-3.81||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-3.81|-6.04|< 0.0001
74070061|NCT02277769|147692085|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-33.73|-21.7||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.70|-33.73|< 0.0001
74070062|NCT02277769|147692085|SUPERIORITY||LS mean difference|-28.9|||<|0.0001|TWO_SIDED|95.0|-35.03|-22.74||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.74|-35.03|< 0.0001
74070063|NCT02277769|147692086|SUPERIORITY||LS mean difference|-17.7|||<|0.0001|TWO_SIDED|95.0|-21.96|-13.53||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.53|-21.96|< 0.0001
73883439|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.836|||<|0.0001|TWO_SIDED|95.0|1.975|5.698|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.698|1.975|<.0001
74070064|NCT02277769|147692086|SUPERIORITY||LS mean difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.16|-10.78||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-10.78|-19.16|< 0.0001
74070065|NCT01488578|147692095|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
74070066|NCT01488578|147692098|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.032|TWO_SIDED||||||Chi-squared|||||||=0.032
74070067|NCT01488578|147692099|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
74070068|NCT01488578|147692100|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
74070069|NCT01488578|147692101|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
74070070|NCT01488578|147692102|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||The Hosmer-Lemeshow Goodness-of-Fit TEST|||||||<0.001
74070071|NCT01488578|147692104|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.006|TWO_SIDED||||||Chi-squared|||||||=0.006
74070072|NCT01488578|147692105|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
74070073|NCT01488578|147692106|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.015|TWO_SIDED||||||Chi-squared|||||||=0.015
74070074|NCT01488578|147692107|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
74070075|NCT01488578|147692108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73883440|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.859|||<|0.0001|TWO_SIDED|95.0|1.936|5.781|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.781|1.936|<.0001
74070076|NCT02308111|147692110|SUPERIORITY||Hazard Ratio, log|1.01||||0.954|TWO_SIDED|95.0|0.68|1.51||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the interactive web response system (IWRS) as strata|Log Rank|||||1.51|0.68|0.954
74070077|NCT02308111|147692111|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.304|TWO_SIDED|95.0|0.61|1.16||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.16|0.61|0.304
73883441|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.899||||0.0002|TWO_SIDED|95.0|1.866|5.933|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.933|1.866|0.0002
73888339|NCT01746901|147309549|SUPERIORITY_OR_OTHER||LS Mean Difference|100.0||||0.0273|TWO_SIDED|95.0|11.3|188.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||188.6|11.3|0.0273
74070078|NCT02308111|147692112|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.898|TWO_SIDED|95.0|0.69|1.52||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.52|0.69|0.898
74070079|NCT02308111|147692113|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.594|TWO_SIDED|95.0|0.69|1.91||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.91|0.69|0.594
74070080|NCT02308111|147692114|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.568|TWO_SIDED|95.0|0.57|2.78||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||2.78|0.57|0.568
74070081|NCT02308111|147692115|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.769|TWO_SIDED|95.0|0.59|2.07||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the interactive web response system (IWRS) as strata.|Gray's Test|||||2.07|0.59|0.769
74070082|NCT02308111|147692116|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.599|TWO_SIDED|95.0|0.42|1.67||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.67|0.42|0.599
74070083|NCT02308111|147692117|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.745|TWO_SIDED|95.0|0.18|3.43||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||3.43|0.18|0.745
74070084|NCT02308111|147692118|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.437|TWO_SIDED|95.0|0.43|1.44||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.44|0.43|0.437
74070085|NCT02308111|147692119|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.838|TWO_SIDED|95.0|0.37|2.24||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||2.24|0.37|0.838
74070086|NCT02308111|147692120|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.98|TWO_SIDED|95.0|0.26|4.04||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||4.04|0.26|0.980
74070087|NCT02308111|147692121|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.933|TWO_SIDED|95.0|0.58|1.83||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.83|0.58|0.933
74070088|NCT02308111|147692122|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.468|TWO_SIDED|95.0|0.53|1.34||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.34|0.53|0.468
74070089|NCT02308111|147692123|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.178|TWO_SIDED|95.0|0.13|1.41||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.41|0.13|0.178
74070090|NCT02308111|147692123|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.19|TWO_SIDED|95.0|0.13|1.41|||Cochran-Mantel-Haenszel|||||1.41|0.13|0.190
74070091|NCT02308111|147692124|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.443|TWO_SIDED|95.0|0.05|3.54||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||3.54|0.05|0.443
74070092|NCT03977584|147692281|SUPERIORITY||Difference in Annualized Rate of Change|-0.013|STANDARD_ERROR_OF_MEAN|0.00993||0.1953|TWO_SIDED|95.0|-0.0327|0.0068|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: GTP1 PET = Treatment \* Analysis Year + Interactive Voice or Web Response System (IxRS) defined Age Group + IxRS defined Education History + IxRS defined apolipoprotein (APOE4) Carrier Status + IxRS defined Clinical Dementia Rating Global Score.||0.0068|-0.0327|0.1953
74070093|NCT03504852|147692284|SUPERIORITY||Risk Difference (RD)|17.72||||0.0003|TWO_SIDED|95.0|7.45|27.98||One-sided p-value|Regression, Logistic|||||27.98|7.45|0.0003
74070094|NCT03504852|147692284|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0003|TWO_SIDED|95.0|1.44|3.78||One-sided p-value|Regression, Logistic|||||3.78|1.44|0.0003
74070095|NCT03504852|147692285|SUPERIORITY||Risk Difference (RD)|8.28||||0.0498|TWO_SIDED|95.0|-1.65|18.2||One-sided p-value|Regression, Logistic|||||18.20|-1.65|0.0498
74070096|NCT03504852|147692285|SUPERIORITY||Odds Ratio (OR)|1.51||||0.0498|TWO_SIDED|95.0|0.92|2.47||One-sided p-value|Regression, Logistic|||||2.47|0.92|0.0498
74070097|NCT01835145|147692293|SUPERIORITY|||||||0.7|||||||Chi-squared|||A one-sided chi-squared test for a difference in PFS4 rates will be used to test for a difference between arms.||||0.70
74070098|NCT00458302|147692386|NON_INFERIORITY_OR_EQUIVALENCE|The primary comparison was performed at Week 48. If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.6|||||TWO_SIDED|95.0|-10.1|6.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment arm, so 250 patients in total.||6.8|-10.1|
74070099|NCT00458302|147692387|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.0|||||TWO_SIDED|95.0|-9.9|7.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment are, so 250 patients in total.||7.8|-9.9|
74070100|NCT00458302|147692389|SUPERIORITY_OR_OTHER||Difference in proportion of response|1.29|||||TWO_SIDED|95.0|-7.99|10.58|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|||10.58|-7.99|
74070101|NCT01379781|147692457|SUPERIORITY||Slope|-6.54||||0.01|TWO_SIDED||||||Mixed Models Analysis|||Mixed effect model was used to compare Hamilton Rating Scales of Depression (HRSD) for women who received the PREPP intervention between the pre-randomization assessment and the 6 weeks postpartum session.||||.01
74070102|NCT01644890|147692458|NON_INFERIORITY|The primary PFS analysis was confirmed whether or not the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) for NK105 relative to PTX fell below the non-inferiority margin of 1.215 (\<1.215) by fitting a Cox proportional hazards model that included allocation adjustment factors other than the study site as covariates.|Hazard Ratio (HR)|1.255|||||TWO_SIDED|95.0|0.989|1.592|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[(+) or (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.|Based on the results of previous studies, the expected median PFS was 5.5 months for PTX and 6.35 months for NK105. Assuming a randomization period of 18 months, a follow-up period of 12 months, a one-sided significance level of 2.5%, a power of 85% and the non-inferiority margin of 1.215, the number of patients was estimated to 172 pts per group, a total of 344 patients. Considering an expected withdrawal/dropout rate of approximately 20%, the target sample size was set at 414.||1.592|0.989|
74070103|NCT01644890|147692459|OTHER||Hazard Ratio (HR)|1.197|||||TWO_SIDED|95.0|0.885|1.62|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[(+) or (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.|||1.620|0.885|
74070104|NCT01644890|147692460|OTHER||Difference in ORR (%)|-7.5|||||TWO_SIDED|95.0|-17.4|2.7||||||||2.7|-17.4|
74070105|NCT02146430|147692488|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.187||0.187|TWO_SIDED|95.0|-0.61|0.12|||Difference of means|||||0.12|-0.61|0.1870
74070106|NCT02146430|147692488|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.185||0.0944|TWO_SIDED|95.0|-0.67|0.05|||Difference of means|||||0.05|-0.67|0.0944
74070107|NCT02146430|147692488|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.187||0.1391|TWO_SIDED|95.0|-0.64|0.09|||Difference of means|||||0.09|-0.64|0.1391
74070108|NCT02146430|147692488|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.187||0.7338|TWO_SIDED|95.0|-0.43|0.3|||Difference of means|||||0.30|-0.43|0.7338
74070109|NCT02146430|147692488|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.8705|TWO_SIDED|95.0|-0.4|0.34|||Difference of means|||||0.34|-0.40|0.8705
74070110|NCT02146430|147692490|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|1.592||0.0326|TWO_SIDED|95.0|-6.52|-0.28|||Difference of means|||||-0.28|-6.52|0.0326
74070111|NCT02146430|147692490|SUPERIORITY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|1.592||0.422|TWO_SIDED|95.0|-4.4|1.84|||Difference of means|||||1.84|-4.40|0.4220
74070112|NCT02146430|147692490|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|1.615||0.9659|TWO_SIDED|95.0|-3.1|3.23|||Difference of means|||||3.23|-3.10|0.9659
74070113|NCT02146430|147692490|SUPERIORITY||Mean Difference (Final Values)|2.12|STANDARD_ERROR_OF_MEAN|1.608||0.1867|TWO_SIDED|95.0|-1.03|5.28|||Difference of means|||||5.28|-1.03|0.1867
74070114|NCT02146430|147692490|SUPERIORITY||Mean Difference (Final Values)|3.47|STANDARD_ERROR_OF_MEAN|1.631||0.0333|TWO_SIDED|95.0|0.27|6.67|||Difference of means|||||6.67|0.27|0.0333
74070115|NCT02146430|147692492|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2474|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||||0.2|-0.9|0.2474
74070116|NCT02146430|147692492|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.3347|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.3347
74070117|NCT02146430|147692492|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.3999|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||||0.8|-0.3|0.3999
74070118|NCT02146430|147692492|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.8435|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.8435
74070119|NCT02146430|147692492|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0446|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||||1.1|0.0|0.0446
74070120|NCT02146430|147692493|SUPERIORITY||Difference of least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.9775|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||0.5|-0.5|0.9775
74070121|NCT02146430|147692493|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.65|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.4|-0.6|0.6500
74070122|NCT02146430|147692493|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6546|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.4|-0.6|0.6546
74070123|NCT02146430|147692493|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6692|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.4|-0.6|0.6692
74070124|NCT02146430|147692493|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6737|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.4|-0.6|0.6737
74070125|NCT02146430|147692493|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.3888|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||0.3|-0.8|0.3888
74070126|NCT02146430|147692493|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.92|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0.6|-0.5|0.9200
74070127|NCT02146430|147692493|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7061|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||0.6|-0.4|0.7061
74070128|NCT02146430|147692493|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.3337|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.3|0.3337
74070129|NCT02146430|147692493|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.2139|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|-0.2|0.2139
74070130|NCT02146430|147692494|SUPERIORITY||Difference in least squares means|2.197|STANDARD_ERROR_OF_MEAN|1.4933||0.1416|TWO_SIDED|95.0|-0.733|5.126|||ANCOVA|||Physical Component: Placebo vs Pregabalin 150 mg BID||5.126|-0.733|0.1416
74070131|NCT02146430|147692494|SUPERIORITY||Difference in least squares means|0.249|STANDARD_ERROR_OF_MEAN|1.492||0.8677|TWO_SIDED|95.0|-2.679|3.176|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||3.176|-2.679|0.8677
74070132|NCT02146430|147692494|SUPERIORITY||Difference in least squares means|-0.899|STANDARD_ERROR_OF_MEAN|1.4959||0.5481|TWO_SIDED|95.0|-3.834|2.036|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||2.036|-3.834|0.5481
74070133|NCT02146430|147692494|SUPERIORITY||Difference in least squares means|-1.948|STANDARD_ERROR_OF_MEAN|1.4875||0.1906|TWO_SIDED|95.0|-4.866|0.971|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.971|-4.866|0.1906
74070134|NCT02146430|147692494|SUPERIORITY||Difference in least squares means|-3.095|STANDARD_ERROR_OF_MEAN|1.4883||0.0378|TWO_SIDED|95.0|-6.015|-0.175|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||-0.175|-6.015|0.0378
74070135|NCT02146430|147692494|SUPERIORITY||Difference in least squares means|0.664|STANDARD_ERROR_OF_MEAN|0.6865||0.3337|TWO_SIDED|95.0|-0.683|2.011|||ANCOVA|||Mental Component: Placebo vs Pregabalin 150 mg BID||2.011|-0.683|0.3337
74070136|NCT02146430|147692494|SUPERIORITY||Difference in least squares means|-0.194|STANDARD_ERROR_OF_MEAN|0.686||0.7778|TWO_SIDED|95.0|-1.54|1.152|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.152|-1.540|0.7778
74070137|NCT02146430|147692494|SUPERIORITY||Difference in least squares means|-0.087|STANDARD_ERROR_OF_MEAN|0.6879||0.8991|TWO_SIDED|95.0|-1.437|1.262|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||1.262|-1.437|0.8991
74070138|NCT02146430|147692494|SUPERIORITY||Difference in least squares means|-0.857|STANDARD_ERROR_OF_MEAN|0.6833||0.2098|TWO_SIDED|95.0|-2.198|0.483|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.483|-2.198|0.2098
74070139|NCT02146430|147692494|SUPERIORITY||Difference in least squares means|-0.751|STANDARD_ERROR_OF_MEAN|0.6842||0.2725|TWO_SIDED|95.0|-2.093|0.591|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.591|-2.093|0.2725
74070140|NCT02146430|147692495|SUPERIORITY||Difference in least squares means|0.0018|STANDARD_ERROR_OF_MEAN|0.01329||0.8923|TWO_SIDED|95.0|-0.0243|0.0279|||ANCOVA|||||0.0279|-0.0243|0.8923
74070141|NCT02146430|147692495|SUPERIORITY||Difference in least squares means|-0.0021|STANDARD_ERROR_OF_MEAN|0.01327||0.8749|TWO_SIDED|95.0|-0.0281|0.024|||ANCOVA|||||0.0240|-0.0281|0.8749
74070142|NCT02146430|147692495|SUPERIORITY||Difference in least squares means|-0.0091|STANDARD_ERROR_OF_MEAN|0.01332||0.4932|TWO_SIDED|95.0|-0.0353|0.017|||ANCOVA|||||0.0170|-0.0353|0.4932
74070143|NCT02146430|147692495|SUPERIORITY||Difference in least squares means|-0.0039|STANDARD_ERROR_OF_MEAN|0.01323||0.7688|TWO_SIDED|95.0|-0.0298|0.0221|||ANCOVA|||||0.0221|-0.0298|0.7688
74070144|NCT02146430|147692495|SUPERIORITY||Difference in least squares means|-0.0109|STANDARD_ERROR_OF_MEAN|0.01326||0.4099|TWO_SIDED|95.0|-0.0369|0.0151|||ANCOVA|||||0.0151|-0.0369|0.4099
74070145|NCT02146430|147692496|SUPERIORITY||Difference in least squares means|-0.55|STANDARD_ERROR_OF_MEAN|0.166||0.0009|TWO_SIDED|95.0|-0.88|-0.23|||Mixed Models Analysis|||||-0.23|-0.88|0.0009
74070146|NCT02146430|147692496|SUPERIORITY||Difference in least squares means|-0.63|STANDARD_ERROR_OF_MEAN|0.166||0.0001|TWO_SIDED|95.0|-0.96|-0.31|||Mixed Models Analysis|||||-0.31|-0.96|0.0001
74070147|NCT02146430|147692496|SUPERIORITY||Difference in least squares means|-0.85|STANDARD_ERROR_OF_MEAN|0.167|<|0.0001|TWO_SIDED|95.0|-1.17|-0.52|||Mixed Models Analysis|||||-0.52|-1.17|<0.0001
74070148|NCT02146430|147692496|SUPERIORITY||Difference in least squares means|-0.08|STANDARD_ERROR_OF_MEAN|0.167||0.6408|TWO_SIDED|95.0|-0.4|0.25|||Mixed Models Analysis|||||0.25|-0.40|0.6408
74070149|NCT02146430|147692496|SUPERIORITY||Difference in least squares means|-0.29|STANDARD_ERROR_OF_MEAN|0.167||0.0786|TWO_SIDED|95.0|-0.62|0.03|||Mixed Models Analysis|||||0.03|-0.62|0.0786
74070150|NCT02146430|147692498|SUPERIORITY||Difference of least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0541|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||0.0|-0.7|0.0541
74070151|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.7771|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.3|-0.4|0.7771
74070152|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.5488|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.5488
74070153|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0987|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0987
74070154|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.184|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.1|0.1840
74070155|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1903|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||0.1|-0.6|0.1903
73883442|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.922||||0.0002|TWO_SIDED|95.0|1.826|6.018|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.018|1.826|0.0002
74070156|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5787|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.2|-0.4|0.5787
74070157|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5535|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||0.2|-0.5|0.5535
74070158|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4476|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.2|0.4476
74070159|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4737|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.4737
74070160|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0814|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||0.0|-0.6|0.0814
74070161|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.3069|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||0.2|-0.5|0.3069
74070162|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3916|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||0.2|-0.5|0.3916
74070163|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.4667|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.4|-0.2|0.4667
74070164|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3744|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.3744
74070165|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2959|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||0.2|-0.6|0.2959
74070166|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9119|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9119
74070167|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9399|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.9399
74070168|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2455|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.2455
74070169|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3311|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.3311
74070170|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.254|STANDARD_ERROR_OF_MEAN|0.1647||0.1233|TWO_SIDED|95.0|-0.577|0.069|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||0.069|-0.577|0.1233
74070171|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.072|STANDARD_ERROR_OF_MEAN|0.1643||0.661|TWO_SIDED|95.0|-0.394|0.25|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.250|-0.394|0.6610
74070172|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.098|STANDARD_ERROR_OF_MEAN|0.1649||0.5514|TWO_SIDED|95.0|-0.422|0.225|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||0.225|-0.422|0.5514
74070173|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.182|STANDARD_ERROR_OF_MEAN|0.1638||0.2673|TWO_SIDED|95.0|-0.14|0.503|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.503|-0.140|0.2673
73883443|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.962||||0.0004|TWO_SIDED|95.0|1.753|6.172|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.172|1.753|0.0004
74070174|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.156|STANDARD_ERROR_OF_MEAN|0.1644||0.3439|TWO_SIDED|95.0|-0.167|0.478|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.478|-0.167|0.3439
74070175|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|2.6|STANDARD_ERROR_OF_MEAN|2.4||0.2708|TWO_SIDED|95.0|-2.1|7.4|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs Pregabalin 150 mg BID||7.4|-2.1|0.2708
74070176|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|1.2|STANDARD_ERROR_OF_MEAN|2.4||0.6285|TWO_SIDED|95.0|-3.5|5.9|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg QD||5.9|-3.5|0.6285
73883444|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.985||||0.0006||95.0|1.712|6.258|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.258|1.712|0.0006
74070177|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|2.41||0.9177|TWO_SIDED|95.0|-5.0|4.5|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 150 mg BID||4.5|-5.0|0.9177
74070178|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-1.5|STANDARD_ERROR_OF_MEAN|2.38||0.5334|TWO_SIDED|95.0|-6.2|3.2|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||3.2|-6.2|0.5334
73883445|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.026||||0.001|TWO_SIDED|95.0|1.638|6.413|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.413|1.638|0.0010
73883446|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.048||||0.0012|TWO_SIDED|95.0|1.597|6.5|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.500|1.597|0.0012
73883447|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.089||||0.0018|TWO_SIDED|95.0|1.521|6.656|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.656|1.521|0.0018
73883448|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.111||||0.0022|TWO_SIDED|95.0|1.479|6.743|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.743|1.479|0.0022
74070179|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-2.9|STANDARD_ERROR_OF_MEAN|2.39||0.2261|TWO_SIDED|95.0|-7.6|1.8|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.8|-7.6|0.2261
74070180|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-3.87|STANDARD_ERROR_OF_MEAN|1.758||0.0281|TWO_SIDED|95.0|-7.32|-0.42|||ANCOVA|||Interference: Placebo vs Pregabalin 150 mg BID||-0.42|-7.32|0.0281
74070181|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-1.42|STANDARD_ERROR_OF_MEAN|1.756||0.419|TWO_SIDED|95.0|-4.87|2.03|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg QD||2.03|-4.87|0.4190
74070182|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-1.61|STANDARD_ERROR_OF_MEAN|1.763||0.3622|TWO_SIDED|95.0|-5.06|1.85|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg BID||1.85|-5.06|0.3622
74070183|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|2.45|STANDARD_ERROR_OF_MEAN|1.75||0.1623|TWO_SIDED|95.0|-0.99|5.88|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD||5.88|-0.99|0.1623
74070184|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|2.26|STANDARD_ERROR_OF_MEAN|1.753||0.1978|TWO_SIDED|95.0|-1.18|5.7|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID||5.70|-1.18|0.1978
74070185|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0867|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||General activity: Placebo vs Pregabalin 150 mg BID||0.1|-0.8|0.0867
74070186|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6993|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.6993
74070187|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.8702|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.8702
74070188|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1826|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.1826
74070189|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1206|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1206
74070190|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0211|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Mood: Placebo vs Pregabalin 150 mg BID||-0.1|-0.9|0.0211
74070191|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.4963|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg QD||0.3|-0.6|0.4963
74070192|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3031|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg BID||0.2|-0.6|0.3031
74070193|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1019|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.1019
74070194|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.201|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.2010
74070195|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0331|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||Walking ability: Placebo vs Pregabalin 150 mg BID||-0.0|-0.9|0.0331
74070196|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7478|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.7478
74070197|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.694|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.6940
74070198|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.069|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.0|0.0690
74070199|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0816|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0816
74070200|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1174|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Normal work: Placebo vs Pregabalin 150 mg BID||0.1|-0.7|0.1174
74070201|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.925|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9250
74070202|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.8555|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.8555
74070203|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.0956|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0956
74070204|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1659|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1659
74070205|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0468|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs Pregabalin 150 mg BID||-0.0|-0.8|0.0468
74070206|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1083|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.1083
74070207|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0505|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg BID||0.0|-0.8|0.0505
74070208|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6993|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.6993
74070209|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.9781|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.4|-0.4|0.9781
74070210|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.23||0.0154|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||Sleep: Placebo vs Pregabalin 150 mg BID||-0.1|-1.0|0.0154
74070211|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.0731|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg QD||0.0|-0.9|0.0731
74070212|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0259|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg BID||-0.1|-1.0|0.0259
74070213|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.5243|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.3|0.5243
74070214|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.8488|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.4|0.8488
74070215|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.2746|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Enjoyment of life: Placebo vs Pregabalin 150 mg BID||0.2|-0.7|0.2746
74070216|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.9349|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9349
74070217|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.5164|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg BID||0.6|-0.3|0.5164
74070218|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.2382|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.2|0.2382
74070219|NCT02146430|147692498|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0807|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0807
74070220|NCT02146430|147692499|SUPERIORITY||Difference in least squares means|-0.045|STANDARD_ERROR_OF_MEAN|0.0237||0.0601|TWO_SIDED|95.0|-0.091|0.002|||ANCOVA|||||0.002|-0.091|0.0601
74070221|NCT02146430|147692499|SUPERIORITY||Difference in least squares means|-0.005|STANDARD_ERROR_OF_MEAN|0.0237||0.8299|TWO_SIDED|95.0|-0.052|0.041|||ANCOVA|||||0.041|-0.052|0.8299
74070222|NCT02146430|147692499|SUPERIORITY||Difference in least squares means|-0.05|STANDARD_ERROR_OF_MEAN|0.0237||0.0347|TWO_SIDED|95.0|-0.096|0.004|||ANCOVA|||||0.004|-0.096|0.0347
74070223|NCT02146430|147692499|SUPERIORITY||Difference in least squares means|0.04|STANDARD_ERROR_OF_MEAN|0.0237||0.0951|TWO_SIDED|95.0|-0.007|0.086|||ANCOVA|||||0.086|-0.007|0.0951
74070224|NCT02146430|147692499|SUPERIORITY||Difference in least squares means|-0.005|STANDARD_ERROR_OF_MEAN|0.0237||0.8199|TWO_SIDED|95.0|-0.052|0.041|||ANCOVA|||||0.041|-0.052|0.8199
74070225|NCT01893905|147692500|SUPERIORITY_OR_OTHER||||||<|0.0307|||||||Pocock approach|||||||<0.0307
74070226|NCT03093324|147692501|SUPERIORITY||Rate ratio|0.542||||0.0003|TWO_SIDED|95.0|0.39|0.754|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.754|0.390|0.0003
73883449|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.152||||0.0031|TWO_SIDED|95.0|1.403|6.901|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.901|1.403|0.0031
73883450|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.174||||0.0037||95.0|1.36|6.988|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.988|1.360|0.0037
73883451|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.215||||0.0048|TWO_SIDED|95.0|1.283|7.147|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.147|1.283|0.0048
73883452|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.237||||0.0056|TWO_SIDED|95.0|1.24|7.235|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.235|1.240|0.0056
74070227|NCT03093324|147692502|SUPERIORITY||Rate ratio|0.52||||0.0007|TWO_SIDED|95.0|0.356|0.76|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.760|0.356|0.0007
74070228|NCT03093324|147692503|SUPERIORITY||Rate ratio|0.714||||0.009|TWO_SIDED|95.0|0.554|0.921|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.921|0.554|0.009
74070229|NCT03093324|147692504|SUPERIORITY||Rate ratio|0.555||||0.009|TWO_SIDED|95.0|0.357|0.862|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.862|0.357|0.009
74070230|NCT03093324|147692505|SUPERIORITY||Rate ratio|0.696||||0.033|TWO_SIDED|95.0|0.499|0.972|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.972|0.499|0.033
74070231|NCT03093324|147692506|SUPERIORITY||Rate ratio|0.662||||0.068|TWO_SIDED|95.0|0.425|1.031|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||1.031|0.425|0.068
74070232|NCT03093324|147692507|SUPERIORITY||Rate ratio|0.713||||0.215|TWO_SIDED|95.0|0.417|1.217|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||1.217|0.417|0.215
74070233|NCT03093324|147692508|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.043|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Nausea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.0|-0.6|0.043
74070234|NCT03093324|147692508|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|||Vomiting: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.2|-0.7|<0.001
73883453|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.278||||0.0071|TWO_SIDED|95.0|1.162|7.394|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.394|1.162|0.0071
74070235|NCT03093324|147692508|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.001|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||Upper Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.2|-0.9|0.001
74070236|NCT03093324|147692508|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.403|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Lower Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||0.2|-0.4|0.403
74070237|NCT03093324|147692508|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.261|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Diarrhea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||0.2|-0.6|0.261
74070238|NCT02743702|147692600|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74070239|NCT02059993|147692651|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The sample size was calculated to assess a minimum reduction of 5 ± 5 mm Hg in systolic BPafter CPAP treatment, assuming an alpha error of 5% and a statistical power of 80%.||||<0.05
74070240|NCT02059993|147692652|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
74070241|NCT02655237|147692654|NON_INFERIORITY|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between Relugolix 40 mg group and leuprorelin group (Relugolix 40 mg group - leuprorelin group), using Farrington and Manning (FM) method. If the lower boundary of the 95% CI was greater or equal to the non-inferiority margin of -15%, then the non-inferiority of Relugolix 40 mg to leuprorelin was concluded.|Difference in percentage|-0.9||||0.0013|TWO_SIDED|95.0|-10.098|8.346|||Farrington and Manning (FM)||Relugolix 40 mg-Leuprorelin|||8.346|-10.098|0.0013
74070242|NCT02655237|147692655|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|32.5|||||TWO_SIDED|95.0|20.953|44.134|||||Relugolix 40 mg-Leuprorelin|||44.134|20.953|
73888340|NCT01746901|147309550|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|||<|0.0001|TWO_SIDED|95.0|-5.0|-1.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.8|-5.0|<0.0001
73883454|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.0081|TWO_SIDED|95.0|1.119|7.482|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.482|1.119|0.0081
74070243|NCT02655237|147692656|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-10.6|||||TWO_SIDED|95.0|-18.337|-2.883|||||Relugolix 40 mg-Leuprorelin|||-2.883|-18.337|
74070244|NCT02655237|147692657|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-13.3|||||TWO_SIDED|95.0|-21.418|-5.118|||||Relugolix 40 mg-Leuprorelin|||-5.118|-21.418|
74070245|NCT02655237|147692658|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-12.05|||||TWO_SIDED|95.0|-19.778|-4.33|||||Relugolix 40 mg-Leuprorelin|Week 2||-4.330|-19.778|
74070246|NCT02655237|147692658|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-2.55|||||TWO_SIDED|95.0|-11.916|6.819|||||Relugolix 40 mg-Leuprorelin|Week 4||6.819|-11.916|
74070247|NCT02655237|147692658|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|4.69|||||TWO_SIDED|95.0|-3.141|12.529|||||Relugolix 40 mg-Leuprorelin|Week 8||12.529|-3.141|
74070248|NCT02655237|147692658|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.59|||||TWO_SIDED|95.0|-3.433|10.605|||||Relugolix 40 mg-Leuprorelin|Week 12||10.605|-3.433|
74070249|NCT02655237|147692658|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.96|||||TWO_SIDED|95.0|-3.319|11.245|||||Relugolix 40 mg-Leuprorelin|Week 24||11.245|-3.319|
74070250|NCT02655237|147692659|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-15.15|||||TWO_SIDED|95.0|-20.786|-9.509|||||Relugolix 40 mg-Leuprorelin|Week 2||-9.509|-20.786|
74070251|NCT02655237|147692659|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-10.27|||||TWO_SIDED|95.0|-17.291|-3.246|||||Relugolix 40 mg-Leuprorelin|Week 4||-3.246|-17.291|
74070252|NCT02655237|147692659|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.89|||||TWO_SIDED|95.0|-6.996|5.209|||||Relugolix 40 mg-Leuprorelin|Week 8||5.209|-6.996|
74070253|NCT02655237|147692659|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.94|||||TWO_SIDED|95.0|-6.964|5.076|||||Relugolix 40 mg-Leuprorelin|Week 12||5.076|-6.964|
74070254|NCT02655237|147692659|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|0.86|||||TWO_SIDED|95.0|-6.206|7.935|||||Relugolix 40 mg-Leuprorelin|Week 24||7.935|-6.206|
74070255|NCT02655237|147692660|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||TWO_SIDED|95.0|0.015|0.381|||||Relugolix 40 mg-Leuprorelin|Week 4||0.381|0.015|
74070256|NCT02655237|147692660|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||TWO_SIDED|95.0|-0.135|0.333|||||Relugolix 40 mg-Leuprorelin|Week 8||0.333|-0.135|
74070257|NCT02655237|147692660|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.07|||||TWO_SIDED|95.0|-0.189|0.323|||||Relugolix 40 mg-Leuprorelin|Week 12||0.323|-0.189|
74070258|NCT02655237|147692660|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.01|||||TWO_SIDED|95.0|-0.275|0.251|||||Relugolix 40 mg-Leuprorelin|Week 16||0.251|-0.275|
74070259|NCT02655237|147692660|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.1|||||TWO_SIDED|95.0|-0.386|0.18|||||Relugolix 40 mg-Leuprorelin|Week 20||0.180|-0.386|
74070260|NCT02655237|147692660|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.09|||||TWO_SIDED|95.0|-0.385|0.209|||||Relugolix 40 mg-Leuprorelin|Week 24||0.209|-0.385|
74070261|NCT02655237|147692660|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.49|||||TWO_SIDED|95.0|-0.787|-0.199|||||Relugolix 40 mg-Leuprorelin|Follow up (up to Week 28)||-0.199|-0.787|
74070262|NCT02655237|147692661|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.07|||||TWO_SIDED|95.0|-0.032|0.174|||||Relugolix 40 mg-Leuprorelin|Week 6 to 12||0.174|-0.032|
73883455|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.341||||0.0099|TWO_SIDED|95.0|1.041|7.642|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.642|1.041|0.0099
73883456|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.364||||0.0111|TWO_SIDED|95.0|0.997|7.73|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.730|0.997|0.0111
73883457|NCT00083889|147300793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.404||||0.0133|TWO_SIDED|95.0|0.918|7.89|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.890|0.918|0.0133
74070263|NCT02655237|147692661|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.05|||||TWO_SIDED|95.0|-0.089|0.197|||||Relugolix 40 mg-Leuprorelin|Week 2 to 6||0.197|-0.089|
74070264|NCT02655237|147692661|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.01|||||TWO_SIDED|95.0|-0.06|0.086|||||Relugolix 40 mg-Leuprorelin|Week 18 to 24||0.086|-0.060|
74070265|NCT02655237|147692661|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.02|||||TWO_SIDED|95.0|-0.063|0.099|||||Relugolix 40 mg-Leuprorelin|For 6 Weeks Before the Final Dose (up to Week 24)||0.099|-0.063|
74070266|NCT02655237|147692662|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-2.5|||||TWO_SIDED|95.0|-6.39|1.43|||||Relugolix 40 mg-Leuprorelin|Week 4||1.43|-6.39|
74070267|NCT02655237|147692662|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-4.0|||||TWO_SIDED|95.0|-6.68|-1.31|||||Relugolix 40 mg-Leuprorelin|Week 8||-1.31|-6.68|
74070268|NCT02655237|147692662|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||TWO_SIDED|95.0|-1.99|2.36|||||Relugolix 40 mg-Leuprorelin|Week 12||2.36|-1.99|
73883458|NCT00083889|147300794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5404|||<|0.0001|TWO_SIDED|95.0|0.4532|0.6444||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.6444|0.4532|<0.0001
73883459|NCT00083889|147300794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5418|||<|1e-05|TWO_SIDED|95.0|0.4536|0.6473||p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.6473|0.4536|<.00001
73883460|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.486|||<|0.0001|TWO_SIDED|95.0|3.852|7.119|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) baseline score (intercept and time since randomization are included as random effects).||7.119|3.852|<.0001
74070269|NCT02655237|147692662|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|1.3|||||TWO_SIDED|95.0|-0.68|3.28|||||Relugolix 40 mg-Leuprorelin|Week 16||3.28|-0.68|
73888341|NCT01746901|147309550|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0004|TWO_SIDED|95.0|1.3|4.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.4|1.3|0.0004
74070270|NCT02655237|147692662|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||TWO_SIDED|95.0|-1.8|2.32|||||Relugolix 40 mg-Leuprorelin|Week 20||2.32|-1.80|
74070271|NCT02655237|147692662|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.5|||||TWO_SIDED|95.0|-1.48|2.52|||||Relugolix 40 mg-Leuprorelin|Week 24||2.52|-1.48|
74070272|NCT02655237|147692662|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|3.4|||||TWO_SIDED|95.0|1.08|5.77|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)||5.77|1.08|
74070273|NCT02655237|147692663|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.3|||||TWO_SIDED|95.0|-1.66|6.34|||||Relugolix 40 mg-Leuprorelin|Week 4||6.34|-1.66|
74070274|NCT02655237|147692663|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.7|||||TWO_SIDED|95.0|-0.37|5.77|||||Relugolix 40 mg-Leuprorelin|Week 8||5.77|-0.37|
74070275|NCT02655237|147692663|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.9|||||TWO_SIDED|95.0|-1.84|3.61|||||Relugolix 40 mg-Leuprorelin|Week 12||3.61|-1.84|
74070276|NCT02655237|147692663|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||TWO_SIDED|95.0|-2.61|2.79|||||Relugolix 40 mg-Leuprorelin|Week 16||2.79|-2.61|
74070277|NCT02655237|147692663|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.8|||||TWO_SIDED|95.0|-1.74|3.41|||||Relugolix 40 mg-Leuprorelin|Week 20||3.41|-1.74|
74070278|NCT02655237|147692663|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||TWO_SIDED|95.0|-2.07|2.71|||||Relugolix 40 mg-Leuprorelin|Week 24||2.71|-2.07|
74070279|NCT02655237|147692663|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-1.4|||||TWO_SIDED|95.0|-3.96|1.09|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)||1.09|-3.96|
74070280|NCT00520741|147692677|SUPERIORITY_OR_OTHER||Predicted exit rate at 112 days|0.3|||||TWO_SIDED|95.0|0.246|0.355|||Kaplan-Meier|Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the lower bound of the 95 % prediction interval for the historical-control of 0.653; hereafter referred to as the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.||0.355|0.246|
74070281|NCT00520741|147692679|SUPERIORITY_OR_OTHER||predicted exit rate at 112 days|0.323|||||TWO_SIDED|95.0|0.268|0.378|||Kaplan-Meier|Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.||0.378|0.268|
74070282|NCT03679741|147692683|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|1.99|||TWO_SIDED|95.0|-1.9|5.8|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as test minus control|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect a 5 point difference between the test and control lenses with respect to overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||5.8|-1.9|
74070283|NCT03679741|147692684|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|3.97|STANDARD_DEVIATION|1.138|||TWO_SIDED|95.0|2.27|6.62|||Bayesian multinomial random-effects mode|A 95% Credible Interval for the odds ratio, was used to test for non-inferiority.|Odds ratio was calculated as test over control|||6.62|2.27|
74070284|NCT03679741|147692685|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.022|STANDARD_DEVIATION|0.0074|||TWO_SIDED|95.0|-0.037|-0.008|||Bayesian multivariate normal model|with random effects|Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the low luminance high contrast lighting condition.||-0.008|-0.037|
74070285|NCT03679741|147692685|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.034|STANDARD_DEVIATION|0.0075|||TWO_SIDED|95.0|-0.049|-0.02|||Bayesian multivariate normal model|with random effect|Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the high illumination low contrast lighting condition.||-0.020|-0.049|
74070286|NCT03679741|147692686|SUPERIORITY|A superiority margin of 90% was used. Superiority was concluded if the lower limit of the 95% credible interval was above 90%|Mean Percentage of eyes|100.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|99.0|100.0|||Bayesian beta- binomial model|for correlated binary data||It was calculated that 65 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.||100.0|99.0|
73883461|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.535|||<|0.0001|TWO_SIDED|95.0|3.955|7.115|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.115|3.955|<.0001
74070287|NCT03679741|147692687|NON_INFERIORITY|A non-inferiority cumulative odds ratio margin of 2 was used. This margin corresponds to no more than a 5% difference between the Test and Control lenses assuming the Control reference rate does not exceed 5%. Non-inferiority was declared if the upper bound of the 95% credible interval was below 2.|Mean Difference (Final Values)|0.001|STANDARD_DEVIATION|0.003|||TWO_SIDED|95.0|-0.004|0.008|||Bayesian beta-binomial hierarchical||Mean difference was calculated as Test minus Control.|It was calculated that 50 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods.||0.008|-0.004|
74070288|NCT03679741|147692688|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|1.29|||TWO_SIDED|95.0|3.1|8.1|||Bayesian multivariate normal model|for random effects|Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.||8.1|3.1|
74070289|NCT03679741|147692689|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|1.56|||TWO_SIDED|95.0|-0.6|5.5|||Bayesian multivariate normal model|for random effects|Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.||5.5|-0.6|
74070290|NCT03679741|147692690|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|1.73|STANDARD_DEVIATION|0.459|||TWO_SIDED|95.0|1.0|2.82|||Bayesian multinomial random-effects|A 95% Credible Interval for the odds ratio, was used to test for non-inferiority.|Odds ratio was calculated as test over control|||2.82|1.00|
74070291|NCT02750761|147692710|OTHER|Bioavailability: Geometric least squares mean ratio between the Oral Group's and IV Group's dose normalized AUC from time zero to infinity.|Geometric Least Squares Mean Ratio|1.12|||||TWO_SIDED|90.0|0.93|1.35|||||The Oral Group represented the numerator in the bioavailability ratio, and the IV Group represented the denominator.|||1.35|0.93|
74070292|NCT01860976|147692714|SUPERIORITY_OR_OTHER_LEGACY||Estimate of Difference|17.2|||<|0.001|TWO_SIDED|95.0|8.7|25.6|||Cochran-Mantel-Haenszel|||||25.6|8.7|<0.001
74070293|NCT02419313|147692805|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Fisher Exact|||||||0.0007
74070294|NCT02419313|147692806|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Fisher Exact|||||||0.0008
74070295|NCT02419313|147692807|SUPERIORITY_OR_OTHER|||||||0.0105|TWO_SIDED||||||Fisher Exact|||||||0.0105
74070296|NCT00620763|147692811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.0||0.02||95.0|||||Mixed Models Analysis|Mixed model analysis of variance tested for treatment and feeding sequence effects.||16 subjects required to detect a difference in Calcium 47 absorption of 2 percentage points with 90% power, alpha = 0.05||||0.02
74070297|NCT00368966|147692817|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (\>) -10%.|Difference|-0.6||||||95.0|-2.9|1.6||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 1:8 threshold was calculated||1.6|-2.9|
74070298|NCT00368966|147692817|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.2||||||95.0|-2.3|4.9||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.10 IU/mL threshold was calculated||4.9|-2.3|
74070299|NCT00368966|147692817|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.01 IU/mL threshold was calculated||1.3|-1.3|
73883462|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.562|||<|0.0001|TWO_SIDED|95.0|4.0|7.124|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.124|4.000|<.0001
74070300|NCT00368966|147692818|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||0.86|0.60|
74070301|NCT00368966|147692819|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.81||||||95.0|0.7|0.94||||||For Diphtheria the GMC ratio (13vPnC/7vPnC) was calculated||0.94|0.70|
74070302|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 4, the Geometric Mean fold Rise (GMFR) were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.35|1.13|
74070303|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|9.28||||||95.0|8.18|10.53||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||10.53|8.18|
74070304|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|1.15||||||95.0|1.05|1.25||||||For serotype 6B, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.25|1.05|
74070305|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|1.61||||||95.0|1.41|1.83||||||For serotype 14, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.83|1.41|
74070306|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|1.45||||||95.0|1.3|1.61||||||For serotype 18C, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.61|1.30|
74070307|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|0.93||||||95.0|0.83|1.03||||||For serotype 19F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.03|0.83|
74070308|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|4.0||||||95.0|3.55|4.5||||||For serotype 23F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||4.50|3.55|
74070309|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|1.6||||||95.0|1.46|1.76||||||For serotype 1, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.76|1.46|
74070310|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 3, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.35|1.13|
74070311|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|1.94||||||95.0|1.78|2.11||||||For serotype 5, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||2.11|1.78|
73883463|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.611|||<|0.0001|TWO_SIDED|95.0|4.061|7.162|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.162|4.061|<.0001
74070312|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|2.87||||||95.0|2.58|3.2||||||For serotype 6A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||3.20|2.58|
74070313|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|2.18||||||95.0|1.98|2.41||||||For serotype 7F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||2.41|1.98|
74070314|NCT00368966|147692822|SUPERIORITY_OR_OTHER||Difference|1.3||||||95.0|1.18|1.44||||||For serotype 19A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.44|1.18|
74070315|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.3|-1.3|
74070316|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.9||||||95.0|-6.0|2.0||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated||2.0|-6.0|
74070317|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.3|-1.3|
74070318|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||1.3|-1.3|
74070319|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.3||||||95.0|-5.2|2.6||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 64 EU/mL threshold was calculated||2.6|-5.2|
74070320|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||1.3|-1.3|
73883464|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.639|||<|0.0001|TWO_SIDED|95.0|4.083|7.195|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.195|4.083|<.0001
73883465|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.688|||<|0.0001|TWO_SIDED|95.0|4.1|7.276|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.276|4.100|<.0001
74070321|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-4.4|3.2||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 39 EU/mL threshold was calculated||3.2|-4.4|
74070322|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|1.7||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.7|-1.7|
74070323|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.4||||||95.0|-5.1|2.2||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 11 EU/mL threshold was calculated||2.2|-5.1|
74070324|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.4|-1.4|
74070325|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||1.4|-1.4|
74070326|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-4.6|3.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 99 EU/mL threshold was calculated||3.3|-4.6|
74070327|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||1.4|-1.4|
74070328|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.7||||||95.0|-5.8|2.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 69 EU/mL threshold was calculated||2.3|-5.8|
74070329|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.7|||||TWO_SIDED|95.0|-2.5|0.7||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||0.7|-2.5|
74070330|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.3|-1.3|
74070331|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8|||||TWO_SIDED|95.0|-2.8|0.8||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||0.8|-2.8|
74070332|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.5|-1.5|
74070333|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-2.1|2.9||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||2.9|-2.1|
74070334|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.3|-1.3|
74070335|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.8|||||TWO_SIDED|95.0|-2.1|3.8||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||3.8|-2.1|
74070336|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.7|-1.8|
74070337|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.4|1.3||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||1.3|-1.4|
74070338|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.7|||||TWO_SIDED|95.0|-0.6|2.6||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||2.6|-0.6|
74070339|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-1.0|2.0||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||2.0|-1.0|
74070340|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||1.5|-1.5|
74070341|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-1.1|2.2||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||2.2|-1.1|
74070342|NCT00368966|147692823|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||1.5|-1.5|
74070343|NCT00368966|147692824|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.82|1.23||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated||1.23|0.82|
74070344|NCT00368966|147692824|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.76|1.18||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated||1.18|0.76|
74070345|NCT00368966|147692824|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.76|1.19||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated||1.19|0.76|
74070346|NCT00368966|147692824|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.69|0.98||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated||0.98|0.69|
74070347|NCT00368966|147692824|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.9||||||95.0|0.75|1.09||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated||1.09|0.75|
74070348|NCT00368966|147692824|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.88|1.29||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated||1.29|0.88|
74070349|NCT00368966|147692825|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.75|0.96||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.75|
74070350|NCT00368966|147692825|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.88|1.2||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.20|0.88|
74070351|NCT00368966|147692825|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.71|1.02||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.02|0.71|
74070352|NCT00368966|147692825|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.12||||||95.0|0.9|1.4||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.40|0.90|
74070353|NCT00368966|147692826|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.93|1.13||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.93|
74070354|NCT00368966|147692826|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.96|1.2||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.20|0.96|
74070355|NCT00368966|147692826|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.05||||||95.0|0.92|1.18||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.18|0.92|
74070356|NCT00368966|147692826|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.88|1.14||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.88|
74070357|NCT00368966|147692826|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.88|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.88|
74070358|NCT00368966|147692826|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.78|1.02||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.02|0.78|
74070359|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|0.1|4.4||||||For serotype 4, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||4.4|0.1|
74070360|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|41.2||||||95.0|34.9|46.9||||||For serotype 6B, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||46.9|34.9|
74070361|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|7.3||||||95.0|4.1|10.4||||||For serotype 9V, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||10.4|4.1|
74070362|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-3.4|1.2||||||For serotype 14, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||1.2|-3.4|
74070363|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|6.4||||||95.0|3.1|9.5||||||For serotype 18C, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||9.5|3.1|
74070364|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.4|-0.4|
74070365|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|26.5||||||95.0|20.7|31.9||||||For serotype 23F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||31.9|20.7|
74070366|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|3.0||||||95.0|0.8|5.1||||||For serotype 1, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||5.1|0.8|
74070367|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|-1.8|6.3||||||For serotype 3, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||6.3|-1.8|
74070368|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|10.0||||||95.0|5.9|13.9||||||For serotype 5, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||13.9|5.9|
74070369|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|13.0||||||95.0|8.6|17.2||||||For serotype 6A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||17.2|8.6|
74070370|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.1|3.1||||||For serotype 7F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.1|-0.1|
74070371|NCT00368966|147692827|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.4|-0.4|
74070372|NCT01694485|147692835|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.35||||0.021|TWO_SIDED|90.0|1.41|7.95|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||7.95|1.41|0.021
74070373|NCT01694485|147692835|SUPERIORITY||Difference in Adjusted Remission Rates|9.0|||||TWO_SIDED|90.0|1.6|14.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.6|1.6|
73883466|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.715|||<|0.0001|TWO_SIDED|95.0|4.098|7.333|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.333|4.098|<.0001
73883467|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.764|||<|0.0001|TWO_SIDED|95.0|4.075|7.454|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.454|4.075|<.0001
73883468|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.792|||<|0.0001|TWO_SIDED|95.0|4.053|7.531|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.531|4.053|<.0001
73883469|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.841|||<|0.0001|TWO_SIDED|95.0|3.998|7.684|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.684|3.998|<.0001
74070374|NCT01694485|147692835|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.33||||0.03|TWO_SIDED|90.0|1.34|8.26|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.26|1.34|0.030
74070375|NCT01694485|147692835|SUPERIORITY||Difference in Adjusted Remission Rates|8.9|||||TWO_SIDED|90.0|0.8|14.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.9|0.8|
74070376|NCT01694485|147692835|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.64||||0.64|TWO_SIDED|90.0|0.13|3.17|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.17|0.13|0.64
74070377|NCT01694485|147692835|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.6|||||TWO_SIDED|90.0|-5.2|5.5||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.5|-5.2|
73883470|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.868|||<|0.0001|TWO_SIDED|95.0|3.96|7.777|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.777|3.960|<.0001
74070378|NCT01694485|147692835|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.34||||0.49|TWO_SIDED|90.0|0.03|4.33|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.33|0.03|0.49
74070379|NCT01694485|147692835|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-2.9|||||TWO_SIDED|90.0|-5.5|5.4||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.4|-5.5|
74070380|NCT01694485|147692836|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.78|||<|0.001|TWO_SIDED|90.0|1.71|4.52|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.52|1.71|<0.001
74070381|NCT01694485|147692836|SUPERIORITY||Difference in Adjusted Response Rates|23.4|||||TWO_SIDED|90.0|11.8|33.2||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||33.2|11.8|
74070382|NCT01694485|147692836|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.57||||0.003|TWO_SIDED|90.0|1.53|4.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.31|1.53|0.003
74070383|NCT01694485|147692836|SUPERIORITY||Difference in Adjusted Response Rates|21.4|||||TWO_SIDED|90.0|9.0|31.8||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.8|9.0|
74070384|NCT01694485|147692836|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|2.54||||0.024|TWO_SIDED|90.0|1.29|5.02|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.02|1.29|0.024
74070385|NCT01694485|147692836|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|21.2|||||TWO_SIDED|90.0|4.9|34.1||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||34.1|4.9|
74070386|NCT01694485|147692836|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.4||||0.18|TWO_SIDED|90.0|0.13|1.22|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||1.22|0.13|0.18
74070387|NCT01694485|147692836|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|-13.7|||||TWO_SIDED|90.0|-24.4|2.7||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.7|-24.4|
74070388|NCT01694485|147692837|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.34||||0.011|TWO_SIDED|90.0|1.35|4.07|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors.|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.07|1.35|0.011
74070389|NCT01694485|147692837|SUPERIORITY||Difference in Adjusted Healing Rates|15.3|||||TWO_SIDED|90.0|4.8|24.0||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||24.0|4.8|
74070390|NCT01694485|147692837|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.1||||0.041|TWO_SIDED|90.0|1.15|3.82|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.82|1.15|0.041
74070391|NCT01694485|147692837|SUPERIORITY||Difference in Adjusted Healing Rates|13.0|||||TWO_SIDED|90.0|1.7|22.1||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.1|1.7|
74070392|NCT01694485|147692837|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.8||||0.68|TWO_SIDED|90.0|0.32|1.97|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||1.97|0.32|0.68
74070393|NCT01694485|147692837|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-3.0|||||TWO_SIDED|90.0|-11.9|9.4||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||9.4|-11.9|
74070394|NCT01694485|147692837|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.69||||0.6|TWO_SIDED|90.0|0.21|2.22|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.22|0.21|0.60
74070395|NCT01694485|147692837|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-4.6|||||TWO_SIDED|90.0|-14.9|11.3||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||11.3|-14.9|
74070396|NCT01694485|147692838|SUPERIORITY||Odds Ratio (OR)|2.94||||0.09|TWO_SIDED|90.0|1.03|8.36|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.36|1.03|0.090
74070397|NCT01694485|147692838|SUPERIORITY||Difference in Adjusted Remission Rates|5.8|||||TWO_SIDED|90.0|-0.6|10.4||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||10.4|-0.6|
74070398|NCT01694485|147692838|SUPERIORITY||Odds Ratio (OR)|1.32||||0.72|TWO_SIDED|90.0|0.38|4.56|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.56|0.38|0.72
74070399|NCT01694485|147692838|SUPERIORITY||Difference in Adjusted Remission Rates|1.0|||||TWO_SIDED|90.0|-4.7|4.6||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.6|-4.7|
74070400|NCT01694485|147692838|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.83||||0.86|TWO_SIDED|90.0|0.16|4.41|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.41|0.16|0.86
74070401|NCT01694485|147692838|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-0.5|||||TWO_SIDED|90.0|-3.9|6.2||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.2|-3.9|
74070402|NCT01694485|147692838|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.49||||0.64|TWO_SIDED|90.0|0.04|6.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.31|0.04|0.64
74070403|NCT01694485|147692838|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.7|||||TWO_SIDED|90.0|-4.2|6.4||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.4|-4.2|
74070404|NCT02907203|147692865|NON_INFERIORITY|Compared with the Performance Goal: 0.9mm|Mean Difference (Net)|-0.17|STANDARD_DEVIATION|0.98||0|TWO_SIDED|95.0|-0.5|0.152|||t-test, 2 sided|||||0.152|-0.5|0.000
74070405|NCT00662025|147692870|SUPERIORITY_OR_OTHER||Objective Response Rate (percentage)|30.2|||||TWO_SIDED|95.0|19.2|43.0||||||||43.0|19.2|
74070406|NCT00662025|147692871|SUPERIORITY_OR_OTHER||Objective Response Rate (percentage)|27.0|||||TWO_SIDED|95.0|16.6|39.7||||||||39.7|16.6|
74070407|NCT00662025|147692872|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|50.8|||||TWO_SIDED|95.0|37.9|63.6||||||||63.6|37.9|
74070408|NCT00662025|147692873|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|52.4|||||TWO_SIDED|95.0|39.4|65.1||||||||65.1|39.4|
74070409|NCT00626925|147692890|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74070410|NCT00626925|147692891|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
74070411|NCT00626925|147692893|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
74070412|NCT00626925|147692894|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||0.04
73888342|NCT01746901|147309550|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8478|TWO_SIDED|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.7|0.8478
74070413|NCT00626925|147692895|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74070414|NCT00626925|147692896|SUPERIORITY_OR_OTHER|||||||0.06|||||||Mixed Models Analysis|||||||0.06
74070415|NCT00626925|147692897|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
74070416|NCT02978326|147692948|SUPERIORITY||Least Squares (LS) Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.37||0.0028|TWO_SIDED|95.0|-6.9|-1.5||Mixed Model for Repeated Measures (MMRM) was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||||-1.5|-6.9|0.0028
74070417|NCT02978326|147692949|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.19||0.0252|TWO_SIDED|95.0|-5.1|-0.3||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 3||-0.3|-5.1|0.0252
73883471|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.917|||<|0.0001|TWO_SIDED|95.0|3.88|7.955|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.955|3.880|<.0001
74070418|NCT02978326|147692949|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.31||0.0106|TWO_SIDED|95.0|-6.0|-0.8||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 8||-0.8|-6.0|0.0106
74070419|NCT02978326|147692949|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.44||0.0321|TWO_SIDED|95.0|-6.0|-0.3||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 21||-0.3|-6.0|0.0321
74070420|NCT02978326|147692949|SUPERIORITY||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.34||0.0027|TWO_SIDED|95.0|-6.7|-1.4||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 45||-1.4|-6.7|0.0027
74070421|NCT02978326|147692950|SUPERIORITY||Odds Ratio (OR)|1.79||||0.1004|TWO_SIDED|95.0|0.89|3.6||Generalized estimating equations (GEE) for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 3||3.60|0.89|0.1004
73883472|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.945|||<|0.0001|TWO_SIDED|95.0|3.83|8.06|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.060|3.830|<.0001
73883473|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.994|||<|0.0001|TWO_SIDED|95.0|3.731|8.257|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.257|3.731|<.0001
74070422|NCT02978326|147692950|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0127|TWO_SIDED|95.0|1.2|4.45||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 8||4.45|1.20|0.0127
74070423|NCT02978326|147692950|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0049|TWO_SIDED|95.0|1.34|5.16||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 15||5.16|1.34|0.0049
74070424|NCT02978326|147692950|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0763|TWO_SIDED|95.0|0.94|3.64||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 21||3.64|0.94|0.0763
74070425|NCT02978326|147692950|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0216|TWO_SIDED|95.0|1.13|4.6||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 45||4.60|1.13|0.0216
73883474|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.021|||<|0.0001|TWO_SIDED|95.0|3.672|8.37|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.370|3.672|<.0001
73883475|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.071|||<|0.0001|TWO_SIDED|95.0|3.56|8.581|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.581|3.560|<.0001
74070426|NCT02978326|147692951|SUPERIORITY||Odds Ratio (OR)|3.89||||0.02|TWO_SIDED|95.0|1.24|12.23||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 3||12.23|1.24|0.0200
74070427|NCT02978326|147692951|SUPERIORITY||Odds Ratio (OR)|1.91||||0.099|TWO_SIDED|95.0|0.89|4.13||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 8||4.13|0.89|0.0990
74070428|NCT02978326|147692951|SUPERIORITY||Odds Ratio (OR)|2.53||||0.011|TWO_SIDED|95.0|1.24|5.17||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 15||5.17|1.24|0.0110
74070429|NCT02978326|147692951|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1982|TWO_SIDED|95.0|0.79|3.19||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 21||3.19|0.79|0.1982
74070430|NCT02978326|147692951|SUPERIORITY||Odds Ratio (OR)|2.52||||0.0091|TWO_SIDED|95.0|1.26|5.03||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 45||5.03|1.26|0.0091
74070431|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.41||0.3832|TWO_SIDED|95.0|-6.9|2.7||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 3||2.7|-6.9|0.3832
74070432|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|2.6||0.0415|TWO_SIDED|95.0|-10.5|-0.2||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 8||-0.2|-10.5|0.0415
74070433|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|2.71||0.0606|TWO_SIDED|95.0|-10.5|0.2||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 15||0.2|-10.5|0.0606
74070434|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0318|TWO_SIDED|95.0|-12.1|-0.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 21||-0.6|-12.1|0.0318
74070435|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-7.7|STANDARD_ERROR_OF_MEAN|2.69||0.0047|TWO_SIDED|95.0|-13.0|-2.4||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 45||-2.4|-13.0|0.0047
73883476|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.098|||<|0.0001|TWO_SIDED|95.0|3.495|8.701|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.701|3.495|<.0001
73883477|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.147|||<|0.0001|TWO_SIDED|95.0|3.373|8.921|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.921|3.373|<.0001
73883478|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.174|||<|0.0001|TWO_SIDED|95.0|3.303|9.045|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.045|3.303|<.0001
73883479|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.224|||<|0.0001|TWO_SIDED|95.0|3.174|9.273|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.273|3.174|<.0001
74070436|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|2.5||0.0053|TWO_SIDED|95.0|-12.0|-2.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 3||-2.1|-12.0|0.0053
74070437|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.76||0.0181|TWO_SIDED|95.0|-12.1|-1.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 8||-1.1|-12.1|0.0181
74070438|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|2.82||0.0007|TWO_SIDED|95.0|-15.3|-4.2|||Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 15||-4.2|-15.3|0.0007
74070439|NCT02978326|147692952|OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.79||0.0332|TWO_SIDED|95.0|-11.5|-0.5|||Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 21||-0.5|-11.5|0.0332
74070440|NCT02978326|147692952|OTHER||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.8||0.0048|TWO_SIDED|95.0|-13.5|-2.5||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 45||-2.5|-13.5|0.0048
74070441|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.12||0.184|TWO_SIDED|95.0|-10.3|2.0||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 3||2.0|-10.3|0.1840
74070442|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|3.31||0.0462|TWO_SIDED|95.0|-13.2|-0.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 8||-0.1|-13.2|0.0462
74070443|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|3.36||0.015|TWO_SIDED|95.0|-14.9|-1.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 15||-1.6|-14.9|0.0150
74070444|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|3.53||0.0245|TWO_SIDED|95.0|-15.0|-1.0||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 21||-1.0|-15.0|0.0245
74070445|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|3.34||0.0054|TWO_SIDED|95.0|-16.0|-2.8||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 45||-2.8|-16.0|0.0054
74070446|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|2.77||0.0972|TWO_SIDED|95.0|-10.1|0.9||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 3||0.9|-10.1|0.0972
74070447|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.95||0.0155|TWO_SIDED|95.0|-13.1|-1.4||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 8||-1.4|-13.1|0.0155
74070448|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|3.03||0.0149|TWO_SIDED|95.0|-13.4|-1.5||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 15||-1.5|-13.4|0.0149
74070449|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|3.14||0.025|TWO_SIDED|95.0|-13.3|-0.9||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 21||-0.9|-13.3|0.0250
74070450|NCT02978326|147692952|SUPERIORITY||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|2.96||0.0017|TWO_SIDED|95.0|-15.3|-3.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 45||-3.6|-15.3|0.0017
74070451|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1569|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.5|0.1569
74070452|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0376|TWO_SIDED|95.0|-0.7|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.7|0.0376
74070453|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.1035|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.6|0.1035
74070454|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0037|TWO_SIDED|95.0|-0.9|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.2|-0.9|0.0037
74070455|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0061|TWO_SIDED|95.0|-0.8|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.8|0.0061
73883480|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.251||||0.0001|TWO_SIDED|95.0|3.101|9.401|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.401|3.101|0.0001
74070456|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.7878|TWO_SIDED|95.0|-0.4|0.3||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 3||0.3|-0.4|0.7878
74070457|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0498|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.6|0.0498
74070458|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1719|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.5|0.1719
73883481|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.0002|TWO_SIDED|95.0|2.966|9.634|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.634|2.966|0.0002
74070459|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0161|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.7|0.0161
74070460|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0191|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0191
74070461|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.2537|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.2|0.2537
74070462|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0018|TWO_SIDED|95.0|-0.2|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.2|0.0018
74070463|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.2878|TWO_SIDED|95.0|-0.2|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.2|0.2878
74070464|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.2594|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.2|0.2594
74070465|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0086|TWO_SIDED|95.0|-0.3|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.3|0.0086
74070466|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0424|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.6|0.0424
73883482|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.327||||0.0003|TWO_SIDED|95.0|2.89|9.765|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.765|2.890|0.0003
74070467|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0207|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.6|0.0207
73883483|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.377||||0.0006|TWO_SIDED|95.0|2.751|10.002|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.002|2.751|0.0006
74070468|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.7|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.7|0.0010
74070469|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.0871|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 21||0.0|-0.5|0.0871
73883484|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.404||||0.0008|TWO_SIDED|95.0|2.673|10.135|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.135|2.673|0.0008
73883485|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.453||||0.0013|TWO_SIDED|95.0|2.53|10.376|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.376|2.530|0.0013
74070470|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.568|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 45||0.2|-0.4|0.5680
74070471|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0143|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 3||-0.1|-0.6|0.0143
74070472|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0063|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.6|0.0063
74070473|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0042|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.6|0.0042
74070474|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0137|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.6|0.0137
74070475|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0099|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0099
74070476|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0507|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.5|0.0507
74070477|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0205|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.0205
74070478|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1409|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.5|0.1409
74070479|NCT02978326|147692953|SUPERIORITY|MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2021|TWO_SIDED|95.0|-0.5|0.1|||Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.5|0.2021
73888343|NCT01746901|147309550|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.6192|TWO_SIDED|95.0|-1.9|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.9|0.6192
74070480|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0117|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0117
74070481|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5511|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 3||0.2|-0.4|0.5511
74070482|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4949|TWO_SIDED|95.0|-0.5|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.5|0.4949
74070483|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0203|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.7|0.0203
74070484|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2076|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.6|0.2076
74070485|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0362|TWO_SIDED|95.0|-0.8|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.8|0.0362
74070486|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3589|TWO_SIDED|95.0|-0.1|0.3||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 3||0.3|-0.1|0.3589
74070487|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6991|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.2|0.6991
74070488|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9655|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 15||0.2|-0.2|0.9655
74070489|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8699|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 21||0.2|-0.2|0.8699
74070490|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3715|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.3|0.3715
74070491|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.067|TWO_SIDED|95.0|-0.4|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.4|0.0670
74070492|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0104|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.5|0.0104
74070493|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0122|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.5|0.0122
74070494|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3157|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.3|0.3157
74070495|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0077|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.5|0.0077
74070496|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0078|TWO_SIDED|95.0|-0.8|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 3||-0.1|-0.8|0.0078
74070497|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0372|TWO_SIDED|95.0|-0.7|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.7|0.0372
74070498|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0244|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.7|0.0244
74070499|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0993|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.6|0.0993
74070500|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0185|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.7|0.0185
74070501|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2471|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.2471
74070502|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1076|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.1076
74070503|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2782|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.4|0.2782
74070504|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.4646|TWO_SIDED|95.0|-0.4|0.2|||Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 21||0.2|-0.4|0.4646
74070505|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.16|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.5|0.1600
74070506|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0474|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.5|0.0474
74070507|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0446|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.0446
74070508|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0093|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.6|0.0093
74070509|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2998|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.4|0.2998
74070510|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0545|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.5|0.0545
74070511|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2177|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.2177
74070512|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8||0.1|-0.4|0.2300
73883486|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48||||0.0016|TWO_SIDED|95.0|2.451|10.51|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.510|2.451|0.0016
73883487|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.53||||0.0025|TWO_SIDED|95.0|2.306|10.754|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.754|2.306|0.0025
73883488|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.557||||0.003|TWO_SIDED|95.0|2.224|10.889|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.889|2.224|0.0030
73883489|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.606||||0.0043|TWO_SIDED|95.0|2.077|11.135|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.135|2.077|0.0043
73883490|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.634||||0.0051|TWO_SIDED|95.0|1.995|11.272|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.272|1.995|0.0051
73883491|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.683||||0.0068|TWO_SIDED|95.0|1.847|11.519|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.519|1.847|0.0068
73883492|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.71||||0.0079|TWO_SIDED|95.0|1.764|11.657|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.657|1.764|0.0079
73883493|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.759||||0.01|TWO_SIDED|95.0|1.613|11.905|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.905|1.613|0.0100
74070513|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|95.0|-0.7|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.7|0.0001
74070514|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0151|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.5|0.0151
73883494|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.787||||0.0114|TWO_SIDED|95.0|1.53|12.043|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.043|1.530|0.0114
74070515|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0502|TWO_SIDED|95.0|-0.5|0.0|||Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.5|0.0502
74070516|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3659|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.3|0.3659
74070517|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.6003|TWO_SIDED|95.0|-0.3|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.3|0.6003
73883495|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.836||||0.0141|TWO_SIDED|95.0|1.378|12.293|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.293|1.378|0.0141
74070518|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.0785|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.5|0.0785
74070519|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.3668|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.4|0.3668
74070520|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1827|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.4|0.1827
74070521|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.1327|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.1327
74070522|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0993|TWO_SIDED|95.0|-0.4|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.4|0.0993
74070523|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11||0.0002|TWO_SIDED|95.0|-0.6|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.6|0.0002
74070524|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0056|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.5|0.0056
74070525|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0122|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.5|0.0122
74070526|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1305|TWO_SIDED|95.0|-0.3|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.3|0.1305
74070527|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6638|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 8||0.1|-0.2|0.6638
74070528|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.4341|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.2|0.4341
74070529|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9085|TWO_SIDED|95.0|-0.1|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.1|0.9085
74070530|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.182|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.3|0.1820
74070531|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.1593|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.1|0.1593
74070532|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.6555|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.1|0.6555
73883496|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.863||||0.0157|TWO_SIDED|95.0|1.294|12.432|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.432|1.294|0.0157
74070533|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.017|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.1|0.0170
74070534|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.0188|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 21||0.0|-0.1|0.0188
74070535|NCT02978326|147692953|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0726|TWO_SIDED|95.0|-0.2|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.2|0.0726
74070536|NCT02978326|147692954|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.72||0.0791|TWO_SIDED|95.0|-6.5|0.4||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 3||0.4|-6.5|0.0791
74070537|NCT02978326|147692954|SUPERIORITY||LS Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.86||0.0322|TWO_SIDED|1.86|-7.7|-0.3||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 8||-0.3|-7.7|0.0322
74070538|NCT02978326|147692954|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.91||0.018|TWO_SIDED|95.0|-8.3|-0.8||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 15||-0.8|-8.3|0.0180
74070539|NCT02978326|147692954|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|1.92||0.0271|TWO_SIDED|95.0|-8.1|-0.5||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in MADRS Total Score at 21||-0.5|-8.1|0.0271
74070540|NCT02978326|147692954|SUPERIORITY||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.82||0.0018|TWO_SIDED|95.0|-9.4|-2.2||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in MADRS Total Score at 45||-2.2|-9.4|0.0018
74070541|NCT02978326|147692955|SUPERIORITY||Odds Ratio (OR)|1.4||||0.3372|TWO_SIDED|95.0|0.7|2.81||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 3||2.81|0.70|0.3372
74070542|NCT02978326|147692955|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0935|TWO_SIDED|95.0|0.91|3.47||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 8||3.47|0.91|0.0935
74070543|NCT02978326|147692955|SUPERIORITY||Odds Ratio (OR)|2.16||||0.0276|TWO_SIDED|95.0|1.09|4.28||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 15||4.28|1.09|0.0276
74070544|NCT02978326|147692955|SUPERIORITY||Odds Ratio (OR)|1.79||||0.092|TWO_SIDED|95.0|0.91|3.54||Generalized estimating equations for binary response model was used for estimation with factors for treatment: Baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 21||3.54|0.91|0.0920
74070545|NCT02978326|147692955|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1109|TWO_SIDED|95.0|0.88|3.51||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 45||3.51|0.88|0.1109
74070546|NCT02978326|147692956|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.29||0.0169|TWO_SIDED|95.0|-5.7|-0.6||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 3||-0.6|-5.7|0.0169
74070547|NCT02978326|147692956|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.32||0.001|TWO_SIDED|95.0|-7.0|-1.8||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 8||-1.8|-7.0|0.0010
73883497|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.912||||0.0189|TWO_SIDED|95.0|1.142|12.683|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.683|1.142|0.0189
74070548|NCT02978326|147692956|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.41||0.0063|TWO_SIDED|95.0|-6.7|-1.1||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 15||-1.1|-6.7|0.0063
74070549|NCT02978326|147692956|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.37||0.0119|TWO_SIDED|95.0|-6.2|-0.8||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 21||-0.8|-6.2|0.0119
74070550|NCT02978326|147692956|SUPERIORITY||LS Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.28||0.0002|TWO_SIDED|95.0|-7.5|-2.4||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 45||-2.4|-7.5|0.0002
74070551|NCT02978326|147692957|SUPERIORITY||Odds Ratio (OR)|1.75||||0.1145|TWO_SIDED|95.0|0.87|3.53||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 3||3.53|0.87|0.1145
74070552|NCT02978326|147692957|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1069|TWO_SIDED|95.0|0.89|3.3||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 8||3.30|0.89|0.1069
74070553|NCT02978326|147692957|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0045|TWO_SIDED|95.0|1.36|5.27||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 15||5.27|1.36|0.0045
74070554|NCT02978326|147692957|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0421|TWO_SIDED|95.0|1.03|3.93||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 21||3.93|1.03|0.0421
74070555|NCT02978326|147692957|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0541|TWO_SIDED|95.0|0.99|4.03||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 45||4.03|0.99|0.0541
74070556|NCT02978326|147692958|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0326|TWO_SIDED|95.0|1.09|7.38||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 3||7.38|1.09|0.0326
74070557|NCT02978326|147692958|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3749|TWO_SIDED|95.0|0.68|2.79||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 8||2.79|0.68|0.3749
74070558|NCT02978326|147692958|SUPERIORITY||Odds Ratio (OR)|2.49||||0.0087|TWO_SIDED|95.0|1.26|4.92||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 15||4.92|1.26|0.0087
74070559|NCT02978326|147692958|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0257|TWO_SIDED|95.0|1.1|4.31||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 21||4.31|1.10|0.0257
74070560|NCT02978326|147692958|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0339|TWO_SIDED|95.0|1.06|4.09||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 45||4.09|1.06|0.0339
74070561|NCT02566135|147692965|OTHER||Risk Ratio (RR)|1.4628||||0.5033|TWO_SIDED|95.0|0.6401|3.3428|||Chi-squared, Corrected|||Chi square test was applied to see weather there is a statistical significant difference between group I and group C for attempt for supraglottic airway insertion.||3.3428|0.6401|0.5033
74070562|NCT02566135|147692966|OTHER||Risk Ratio (RR)|0.8972|||>|0.05|TWO_SIDED|95.0|0.4858|1.6569|||Chi-squared, Corrected|||We had applied chi square to see the statistical significant difference between group I and group C for number of attempt for ventilating bougie insertion.||1.6569|0.4858|>0.05
74070563|NCT02566135|147692967|OTHER||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
74070564|NCT02566135|147692968|OTHER|||||||0.44|||||||t-test, 2 sided|||Heart rate beats per minute measured at base line among the group I and group C.||||0.44
74070565|NCT02566135|147692968|OTHER|||||||0.58|||||||t-test, 2 sided|||Heart rate beats per minute is measured following Dexmedetomidine injection among the group I and group C.||||0.58
74070566|NCT02566135|147692968|OTHER|||||||0.16|||||||t-test, 2 sided|||Heart rate beats per minute measured following induction of anaesthesia among the group I and group C.||||0.16
74070567|NCT02566135|147692968|OTHER|||||||0.22|||||||t-test, 2 sided|||Heart rate beats per minute measured following supraglottic airway insertion among the group I and group C.||||0.22
74070568|NCT02566135|147692968|OTHER|||||||0.059|||||||t-test, 2 sided|||Heart rate beats per minute measured following ventilating bougie insertion among the group I and group C.||||0.059
74070569|NCT02566135|147692968|OTHER||||||>|0.33|||||||t-test, 2 sided|||Heart rate beats per minute measured at endotracheal intubation among the group I and group C.||||>0.33
74070570|NCT02566135|147692968|OTHER|||||||0.63|||||||t-test, 2 sided|||Heart rate beats per minute measured after 3 minute of ETT insertion among the group I and group C.||||0.63
74070571|NCT02566135|147692968|OTHER|||||||0.29|||||||t-test, 2 sided|||Heart rate beats per minute measured after 5 minute of ETT insertion among the group I and group C.||||0.29
74070572|NCT02566135|147692968|OTHER|||||||0.18|||||||t-test, 2 sided|||Heart rate beats per minute measured after 7 minute of ETT insertion among the group I and group C.||||0.18
74070573|NCT02566135|147692968|OTHER|||||||0.98|||||||t-test, 2 sided|||Heart rate beats per minute measured after 10 minute of ETT insertion among the group I and group C.||||0.98
74070574|NCT02566135|147692968|OTHER|||||||0.49|||||||t-test, 2 sided|||Heart rate beats per minute measured after 15 minute of ETT insertion among the group I and group C.||||0.49
74070575|NCT02566135|147692969|OTHER|||||||0.24|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at base line between group I and group C.||||0.24
74070576|NCT02566135|147692969|OTHER|||||||0.11|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.||||0.11
74070577|NCT02566135|147692969|OTHER|||||||0.07|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following induction os anaesthesia between group I and group C.||||0.07
74070578|NCT02566135|147692969|OTHER|||||||0.85|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.||||0.85
74070579|NCT02566135|147692969|OTHER|||||||0.055|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.||||0.055
74070580|NCT02566135|147692969|OTHER|||||||0.71|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at ETT insertion time between group I and group C.||||0.71
74070581|NCT02566135|147692969|OTHER|||||||0.2|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 3 minutes after ETT insertion between group I and group C.||||0.20
74070582|NCT02566135|147692969|OTHER|||||||0.86|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 5 minutes after ETT insertion between group I and group C.||||0.86
74070583|NCT02566135|147692969|OTHER|||||||0.68|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 7 minutes after ETT insertion between group I and group C.||||0.68
74070584|NCT02566135|147692969|OTHER|||||||0.98|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 10 minutes after ETT insertion between group I and group C.||||0.98
74070585|NCT02566135|147692969|OTHER|||||||0.49|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 15 minutes after ETT insertion between group I and group C.||||0.49
74070586|NCT02566135|147692970|OTHER|||||||0.34|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared at base line between group I and group C.||||0.34
74070587|NCT02566135|147692970|OTHER|||||||0.27|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.||||0.27
74070588|NCT02566135|147692970|OTHER|||||||0.22|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following induction of anaesrthesia between group I and group C.||||0.22
74070589|NCT02566135|147692970|OTHER|||||||0.96|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.||||0.96
74070590|NCT02566135|147692970|OTHER|||||||0.71|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.||||0.71
74070591|NCT02566135|147692970|OTHER|||||||0.55|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared the time of endotracheal tube insertion between group I and group C.||||0.55
74070592|NCT02566135|147692970|OTHER|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 3 minutes after endotracheal tube insertion between group I and group C.||||0.49
74070593|NCT02566135|147692970|OTHER|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 5 minutes after endotracheal tube insertion between group I and group C.||||0.49
74070594|NCT02566135|147692970|OTHER|||||||0.76|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 7 minutes after endotracheal tube insertion between group I and group C.||||0.76
74070595|NCT02566135|147692970|OTHER|||||||0.69|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 10 minutes after endotracheal tube insertion between group I and group C.||||0.69
74070596|NCT02566135|147692970|OTHER|||||||0.81|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 15 minutes after endotracheal tube insertion between group I and group C.||||0.81
74070597|NCT02566135|147692971|OTHER||||||<|0.0001|||||||t-test, 2 sided|||We had compared time of insertion for supraglottic airway between group I and group C.||||<0.0001
74070598|NCT02566135|147692972|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74070599|NCT01937364|147692973|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.0334|TWO_SIDED|90.0|-0.7275|-0.0206||One-sided p-value|z-statistic with pooled estimate||RD = Baclofen - Placebo|||-0.0206|-0.7275|0.0334
74070600|NCT01937364|147692974|SUPERIORITY_OR_OTHER|||||||0.3744|||||||Mixed Models Analysis|||Baclofen - Placebo; 24 hours||||0.3744
74070601|NCT01937364|147692974|SUPERIORITY_OR_OTHER|||||||0.7616|||||||Mixed Models Analysis|||Baclofen - Placebo; 48 hours||||0.7616
74070602|NCT01937364|147692974|SUPERIORITY_OR_OTHER|||||||0.1393|||||||Mixed Models Analysis|||Baclofen - Placebo; 72 hours||||0.1393
73883498|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.94||||0.0208|TWO_SIDED|95.0|1.057|12.822|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.822|1.057|0.0208
73883499|NCT00083889|147300795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.989||||0.0244|TWO_SIDED|95.0|0.904|13.074|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||13.074|0.904|0.0244
73883500|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.459|||<|0.0001|TWO_SIDED|95.0|0.805|2.114|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Physical Well Being (PWB) subscale baseline score (intercept and time since randomization are included as random effects).||2.114|0.805|<.0001
73883501|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.453|||<|0.0001|TWO_SIDED|95.0|0.827|2.079|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.079|0.827|<.0001
73883502|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.837|2.063|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.063|0.837|<.0001
73883503|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.444|||<|0.0001|TWO_SIDED|95.0|0.847|2.041|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.041|0.847|<.0001
74070603|NCT01937364|147692975|SUPERIORITY_OR_OTHER|||||||0.33||||||Baclofen - Placebo; Peak Ativan 1mg PO equivalent dose|Wilcoxon (Mann-Whitney)|||||||0.33
74070604|NCT01937364|147692975|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Baclofen - Placebo; Total Ativan 1mg PO equivalent dose||||0.80
74070605|NCT00101582|147692991|SUPERIORITY_OR_OTHER||Chi-Square Statistic|4.1764||||0.041||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed as having WHO grade 3 or 4 oral mucositis in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||Sample size calculations were based on the number of participants needed to detect, with 90% power and 5% type 1 error rate, at least a 25% difference in the incidence of severe OM between the treatment groups. A 25% absolute reduction in the incidence of severe OM from the placebo group was considered by investigators as clinically meaningful in this clinical setting.||||0.0410
74070606|NCT00101582|147692992|SUPERIORITY_OR_OTHER||Chi-Square Statistic|5.8002||||0.016||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0160
74070607|NCT00101582|147692992|SUPERIORITY_OR_OTHER|||||||0.1122||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||To protect the overall type 1 error, the Hochberg procedure was used to adjust for multiple statistical testing of the secondary efficacy endpoints.||||0.1122
74070608|NCT00101582|147692993|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6603||||0.0261|TWO_SIDED|95.0|0.4546|0.9592|||Stratified Log-Rank test|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|Hazard ratio of palifermin over placebo based on Stratified Cox proportional hazard model.|||0.9592|0.4546|0.0261
74070609|NCT00101582|147692993|SUPERIORITY_OR_OTHER|||||||0.1566||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Stratified Log-Rank test|||||||0.1566
74070610|NCT00101582|147692994|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.9715||||0.0463||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed to have the event.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0463
74070611|NCT00101582|147692994|SUPERIORITY_OR_OTHER|||||||0.2314||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.2314
74070612|NCT00101582|147692995|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.2548||||0.0712||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0712
74070613|NCT00101582|147692995|SUPERIORITY_OR_OTHER|||||||0.2849||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.2849
73883504|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.0001|TWO_SIDED|95.0|0.848|2.032|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.032|0.848|<.0001
73883505|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.434|||<|0.0001|TWO_SIDED|95.0|0.844|2.024|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.024|0.844|<.0001
74070614|NCT00101582|147692996|SUPERIORITY_OR_OTHER||Chi-Square Statistic|1.3901||||0.2384||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.2384
74070615|NCT00101582|147692996|SUPERIORITY_OR_OTHER|||||||0.6835||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.6835
74070616|NCT00101582|147692997|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.9039||||0.3417||95.0||||Generalized Cochran-Mantel-Haenszel test for general association|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.3417
74070617|NCT00101582|147692997|SUPERIORITY_OR_OTHER|||||||0.6835||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.6835
74070618|NCT00101582|147692998|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.0027||||0.9587||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.9587
74070619|NCT00101582|147692998|SUPERIORITY_OR_OTHER|||||||0.9587||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.9587
74070620|NCT04583579|147693018|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
74070621|NCT00976664|147693024|SUPERIORITY_OR_OTHER|||||||0.0007|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 6-week visit were assessed via the Wilcoxon rank sums test.||||||.0007
74070622|NCT00976664|147693024|SUPERIORITY_OR_OTHER|||||||0.3913|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 12-week visit were assessed via the Wilcoxon rank sums test.||||||.3913
74070623|NCT00976664|147693025|SUPERIORITY_OR_OTHER|||||||0.002|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 6-week visit were assessed using the Wilcoxon rank sums test.||||||.002
74070624|NCT00976664|147693025|SUPERIORITY_OR_OTHER|||||||0.0336|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 12-week visit were assessed using the Wilcoxon rank sums test.||||||.0336
74070625|NCT05431153|147693040|OTHER||Ratio of adjusted geometric means|98.83|||||TWO_SIDED|90.0|94.0|103.91|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||103.91|94.00|
74070626|NCT05431153|147693040|OTHER||Ratio of adjusted geometric means|98.02|||||TWO_SIDED|90.0|93.88|102.35|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||102.35|93.88|
74070627|NCT05431153|147693040|OTHER||Ratio of adjusted geometric means|98.51|||||TWO_SIDED|90.0|91.79|105.73|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||105.73|91.79|
74070628|NCT05431153|147693041|OTHER||Ratio of adjusted geometric means|96.35|||||TWO_SIDED|90.0|87.48|106.12|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.12|87.48|
74070629|NCT05431153|147693041|OTHER||Ratio of adjusted geometric means|93.47|||||TWO_SIDED|90.0|85.65|102.0|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||102.00|85.65|
74070630|NCT05431153|147693041|OTHER||Ratio of adjusted geometric means|98.01|||||TWO_SIDED|90.0|89.86|106.9|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.90|89.86|
74070631|NCT05431153|147693042|OTHER||Ratio of adjusted geometric means|111.52|||||TWO_SIDED|90.0|99.55|124.93|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||124.93|99.55|
74070632|NCT05431153|147693042|OTHER||Ratio of adjusted geometric means|98.38|||||TWO_SIDED|90.0|90.68|106.73|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.73|90.68|
74070633|NCT05431153|147693043|OTHER||Ratio of adjusted geometric means|111.52|||||TWO_SIDED|90.0|96.46|128.93|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||128.93|96.46|
74070634|NCT05431153|147693043|OTHER||Ratio of adjusted geometric means|81.39|||||TWO_SIDED|90.0|75.06|88.26|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||88.26|75.06|
74070635|NCT04828161|147693049|SUPERIORITY||Least square (LS) mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|-0.86|-0.32|||ANCOVA|||||-0.32|-0.86|<0.001
74070636|NCT04828161|147693049|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.135||0.014|TWO_SIDED|95.0|-0.6|-0.07|||ANCOVA|||||-0.07|-0.60|0.014
74070637|NCT04828161|147693049|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|-0.68|-0.15|||ANCOVA|||||-0.15|-0.68|0.002
73883506|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.431|||<|0.0001|TWO_SIDED|95.0|0.838|2.023|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.023|0.838|<.0001
73883507|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.424|||<|0.0001|TWO_SIDED|95.0|0.819|2.029|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.029|0.819|<.0001
73883508|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.421|||<|0.0001|TWO_SIDED|95.0|0.805|2.037|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.037|0.805|<.0001
73883509|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.415|||<|0.0001|TWO_SIDED|95.0|0.774|2.056|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.056|0.774|<.0001
73883510|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.411|||<|0.0001|TWO_SIDED|95.0|0.753|2.069|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.069|0.753|<.0001
73888344|NCT01746901|147309550|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8857|TWO_SIDED|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.7|0.8857
74070638|NCT01082952|147693093|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||The p value is calculated for the results of ASM proliferation following incubation with eosinophils isolated from patients in each group. p\< 0.05 was considered significant.|ANOVA|Proliferation data was evaluated using two-way factorial ANOVA followed by Bonferroni post hoc test.||||||<0.05
74070639|NCT00135707|147693095|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.42|TWO_SIDED|95.0|0.91|1.25|||Chi-squared|||The primary hypothesis states that antioxidant therapy initiated prior to 16 weeks gestation in women will reduce the frequency of serious maternal and infant complications associated with pregnancy related hypertension. We estimated that with a sample size of 10,000 women, the study would have 90% power to show a 30% reduction in the rate of the primary outcome, from 4% in the placebo to 2.8% in the vitamin group, with a two-sided type I error rate of 5%.||1.25|0.91|0.42
74070640|NCT00135707|147693096|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.79|TWO_SIDED|95.0|0.85|1.24|||Chi-squared|||||1.24|0.85|0.79
74070641|NCT00135707|147693097|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.35|TWO_SIDED|95.0|0.47|1.31|||Chi-squared|||||1.31|0.47|0.35
74070642|NCT00135707|147693098|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.16|TWO_SIDED|95.0|0.39|1.17|||Chi-squared|||||1.17|0.39|0.16
74070643|NCT00135707|147693099|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.63||||0.34|TWO_SIDED|95.0|0.25|1.63|||Chi-squared|||||1.63|0.25|0.34
74070644|NCT00135707|147693100|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.49||||0.11|TWO_SIDED|95.0|0.78|7.94|||Chi-squared|||||7.94|0.78|0.11
74070645|NCT00135707|147693101|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.57|TWO_SIDED|95.0|0.39|1.68|||Chi-squared|||||1.68|0.39|0.57
74070646|NCT00135707|147693102|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.18|TWO_SIDED|95.0|0.89|1.9|||Chi-squared|||||1.90|0.89|0.18
74070647|NCT00135707|147693103|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09||||0.84|TWO_SIDED|95.0|0.48|2.46|||Chi-squared|||||2.46|0.48|0.84
74070648|NCT00135707|147693104|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.33|TWO_SIDED|95.0|0.93|1.24|||Chi-squared|||||1.24|0.93|0.33
74070649|NCT00135707|147693105|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.004|TWO_SIDED|95.0|1.03|1.17|||Chi-squared|||||1.17|1.03|0.004
74070650|NCT00135707|147693106|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.25|TWO_SIDED|95.0|0.95|1.21|||Chi-squared|||||1.21|0.95|0.25
74070651|NCT00135707|147693107|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.15||95.0|0.47|1.12|||Chi-squared|||||1.12|0.47|0.15
74070652|NCT00135707|147693108|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.51|TWO_SIDED|95.0|0.32|1.77|||Chi-squared|||||1.77|0.32|0.51
74070653|NCT00135707|147693109|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21||||0.33|TWO_SIDED|95.0|0.82|1.79|||Chi-squared|||||1.79|0.82|0.33
74070654|NCT00135707|147693110|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.74|TWO_SIDED|95.0|0.75|1.22|||Chi-squared|||||1.22|0.75|0.74
74070655|NCT00135707|147693111|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.12|TWO_SIDED|95.0|0.4|1.11|||Chi-squared|||||1.11|0.40|0.12
74070656|NCT00135707|147693112|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.35|TWO_SIDED|95.0|0.97|1.11|||Chi-squared|||||1.11|0.97|0.35
74070657|NCT00135707|147693114|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3||||0.05|TWO_SIDED|95.0|0.08|1.08|||Chi-squared|||||1.08|0.08|0.05
74070658|NCT00135707|147693115|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.67||||0.05|TWO_SIDED|95.0|0.45|1.01|||Chi-squared|||||1.01|0.45|0.05
74070659|NCT00135707|147693116|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.65
74070660|NCT00135707|147693117|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
74070661|NCT00135707|147693118|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97||||0.63|TWO_SIDED|95.0|0.87|1.09|||Chi-squared|||\<37 weeks' gestation||1.09|0.87|0.63
74070662|NCT00135707|147693118|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.86||||0.16|TWO_SIDED|95.0|0.69|1.06|||Chi-squared|||\<32 weeks' gestation||1.06|0.69|0.16
74070663|NCT00135707|147693119|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.53|TWO_SIDED|95.0|0.72|1.19|||Chi-squared|||||1.19|0.72|0.53
73883511|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.405|||<|0.0001|TWO_SIDED|95.0|0.711|2.099|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.099|0.711|<.0001
74070664|NCT00135707|147693120|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.55
74070665|NCT00135707|147693121|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.79|1.27|||Chi-squared|||||1.27|0.79|0.98
74070666|NCT00135707|147693122|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07|||Chi-squared|||||1.07|0.81|0.32
74070667|NCT00135707|147693123|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.58|TWO_SIDED|95.0|0.92|1.15|||Chi-squared|||||1.15|0.92|0.58
74070668|NCT00135707|147693124|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04||||0.75|TWO_SIDED|95.0|0.83|1.3|||Chi-squared|||||1.30|0.83|0.75
74070669|NCT00135707|147693125|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.78|TWO_SIDED|95.0|0.29|2.54|||Chi-squared|||||2.54|0.29|0.78
74070670|NCT00135707|147693126|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.76|2.23|||Chi-squared|||||2.23|0.76|0.34
74070671|NCT00135707|147693127|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71||||0.41|TWO_SIDED|95.0|0.32|1.6|||Chi-squared|||||1.60|0.32|0.41
74070672|NCT00135707|147693128|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.62|TWO_SIDED|95.0|0.61|2.3|||Chi-squared|||||2.30|0.61|0.62
74070673|NCT00135707|147693129|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.56|TWO_SIDED|95.0|0.49|1.48|||Chi-squared|||||1.48|0.49|0.56
74070674|NCT00135707|147693130|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
74070675|NCT00135707|147693131|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.86|TWO_SIDED|95.0|0.82|1.26|||Chi-squared|||||1.26|0.82|0.86
74070676|NCT00135707|147693132|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||0.32|TWO_SIDED|95.0|0.89|1.42|||Chi-squared|||||1.42|0.89|0.32
73883512|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.402||||0.0001|TWO_SIDED|95.0|0.685|2.119|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.119|0.685|0.0001
74070677|NCT03093454|147693133|EQUIVALENCE|Linear mixed effects models were used to investigate HADS scores (total, anxiety, and depression), sleep scores, and pain scores. Variables for time point (preoperative/Post-op Day 1/final Post-op Day) \& arm were analyzed. Adjustment for multiple pairwise comparisons used the Scheffe method. Analyses were conducted based on the intent to treat principle. P-values\<0.05 were considered statistically significant. Each time point, the mean and corresponding 95% confidence interval has been plotted.|Odds Ratio (OR)|95.0|STANDARD_DEVIATION|1.0||0.05|TWO_SIDED|95.0||||The p value is calculated and adjusted for multiple comparisons.|Fisher Exact|||Lavender group compared to control group||||0.05
74070678|NCT04540497|147693138|OTHER||Hazard Ratio (HR)|0.13|||||TWO_SIDED|95.0|0.06|0.28|||||Inebilizumab versus placebo|||0.28|0.06|
74070679|NCT04540497|147693145|OTHER||Hazard Ratio (HR)|0.12|||||TWO_SIDED|95.0|0.05|0.26|||||Inebilizumab vs placebo|||0.26|0.05|
74070680|NCT01681030|147693152|SUPERIORITY_OR_OTHER||Proportion|0.923|||||TWO_SIDED|95.0|0.64|0.998|||||CI for EVARREST Group|||0.998|0.640|
74070681|NCT01681030|147693152|SUPERIORITY_OR_OTHER||Proportion|0.333|||||TWO_SIDED|95.0|0.133|0.59|||||CI for Topical Hemostat group|||0.590|0.133|
74070682|NCT01681030|147693152|SUPERIORITY_OR_OTHER||Proportion|0.455|||||TWO_SIDED|95.0|0.167|0.766|||||CI for Standard of Care group|||0.766|0.167|
74070683|NCT01521559|147693169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.6||||0.0003|TWO_SIDED|95.0|13.0|40.1||P-value was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (Japan vs North America) and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200).|Cochran-Mantel-Haenszel||Difference was IAI group minus laser group; Difference and confidence interval were calculated using Mantel-Haenszel weighting scheme adjusted by regions (Japan vs North America) and baseline BCVA (BCVA ≤20/200 and BCVA \>20/200).|||40.1|13.0|0.0003
74070684|NCT01521559|147693170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.5|||<|0.0001|TWO_SIDED|95.0|7.1|14.0|||ANCOVA|||Difference was IAI group minus laser group. P-value, Point estimate and 95% confidence interval (CI) were based on an analysis of covariance (ANCOVA) model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||14.0|7.1|<0.0001
73883513|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.396||||0.0003|TWO_SIDED|95.0|0.634|2.157|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.157|0.634|0.0003
74070685|NCT01521559|147693171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-148.6|||<|0.0001|TWO_SIDED|95.0|-179.8|-117.4|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||-117.4|-179.8|<0.0001
74070686|NCT01521559|147693172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.0833|TWO_SIDED|95.0|-0.3|5.5|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||5.5|-0.3|0.0833
74070687|NCT02584140|147693210|OTHER||||||<|0.001||||||The P-Value for Week 4 was \<0.001; The P-Value for Week 12 was 0.005; The P-Value for Week 24 was 0.029; The P-Value for Week 36 was 0.008; The P-Value for Week 48 was 0.03.|Wilcoxon (Mann-Whitney)|||||||<0.001
74070688|NCT01700621|147693222|NON_INFERIORITY|A noninferiority margin of -10% was chosen as the maximal absolute reduction in proportion seroprotection allowed in the concomitant measles-rubella and rotavirus vaccine group as compared to the measles-rubella vaccine alone group.|Seroconversion proportion difference|1.1|||||TWO_SIDED|95.0|-6.9|9.0||||||||9.0|-6.9|
74070689|NCT03179345|147693260|SUPERIORITY||Mean Difference (Net)|-0.141|STANDARD_ERROR_OF_MEAN|0.06||0.0275|TWO_SIDED|95.0|-0.266|-0.016|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within Sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||-0.016|-0.266|0.0275
74070690|NCT03179345|147693260|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0611|TWO_SIDED|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.245|-0.006|0.0611
74070691|NCT03179345|147693261|SUPERIORITY||Mean Difference (Net)|-0.102|STANDARD_ERROR_OF_MEAN|0.06||0.1103|TWO_SIDED|95.0|-0.227|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.024|-0.227|0.1103
74070692|NCT03179345|147693261|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0611|TWO_SIDED|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.245|-0.006|0.0611
74070693|NCT03179345|147693262|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9946|TWO_SIDED|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.02|0.9946
74070694|NCT03179345|147693262|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.0125||0.1673|TWO_SIDED|95.0|-0.01|0.04|||ANCOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.04|-0.01|0.1673
74070695|NCT03179345|147693262|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.0125||0.6208|TWO_SIDED|95.0|-0.02|0.03|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.03|-0.02|0.6208
74070696|NCT03179345|147693263|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|2.6||0.8799|TWO_SIDED|95.0|-5.59|4.8|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||4.80|-5.59|0.8799
74070697|NCT03179345|147693263|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|2.61||0.9277|TWO_SIDED|95.0|-4.97|5.45|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||5.45|-4.97|0.9277
74070698|NCT03179345|147693263|SUPERIORITY||Mean Difference (Net)|-3.73||||0.1587|TWO_SIDED|95.0|-8.94|1.49|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.49|-8.94|0.1587
74070699|NCT03179345|147693264|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0125||0.7111|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.03|0.7111
74070700|NCT03179345|147693264|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9048|TWO_SIDED|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.02|0.9048
74070701|NCT03179345|147693264|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3262|TWO_SIDED|95.0|-0.03|0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.01|-0.03|0.3262
74070702|NCT03179345|147693265|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.86||0.595|TWO_SIDED|95.0|-2.18|1.26|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.26|-2.18|0.5950
74070703|NCT03179345|147693265|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.865||0.7057|TWO_SIDED|95.0|-1.4|2.06|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||2.06|-1.40|0.7057
74070704|NCT03179345|147693265|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.865||0.6741|TWO_SIDED|95.0|-1.36|2.1|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||2.10|-1.36|0.6741
74070705|NCT03179345|147693266|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.0175||0.007|TWO_SIDED|95.0|-0.08|-0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||-0.01|-0.08|0.0070
74070706|NCT03179345|147693266|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.0175||0.5183|TWO_SIDED|95.0|-0.02|0.05|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.05|-0.02|0.5183
74070707|NCT03179345|147693266|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.0175||0.5084|TWO_SIDED|95.0|-0.05|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.05|0.5084
74070708|NCT03179345|147693267|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.307||0.1026|TWO_SIDED|95.0|-0.104|1.124|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.124|-0.104|0.1026
74070709|NCT03179345|147693267|SUPERIORITY||Mean Difference (Net)|-0.094|STANDARD_ERROR_OF_MEAN|0.309||0.7634|TWO_SIDED|95.0|-0.711|0.523|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.523|-0.711|0.7634
74070710|NCT03179345|147693267|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.309||0.1041|TWO_SIDED|95.0|-0.107|1.127|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.127|-0.107|0.1041
74070711|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.286|STANDARD_ERROR_OF_MEAN|0.12||0.0177|TWO_SIDED|95.0|-0.521|-0.051|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||-0.051|-0.521|0.0177
74070712|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.157|STANDARD_ERROR_OF_MEAN|0.19||0.412|TWO_SIDED|95.0|-0.536|0.222|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.222|-0.536|0.4120
74070713|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.046|STANDARD_ERROR_OF_MEAN|0.16||0.7724|TWO_SIDED|95.0|-0.362|0.27|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.270|-0.362|0.7724
74070714|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.15||0.4255|TWO_SIDED|95.0|-0.423|0.18|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.180|-0.423|0.4255
74070715|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.12||0.8925|TWO_SIDED|95.0|-0.229|0.262|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in activities||0.262|-0.229|0.8925
74070716|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.212|STANDARD_ERROR_OF_MEAN|0.14||0.1293|TWO_SIDED|95.0|-0.487|0.063|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.063|-0.487|0.1293
74070717|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0304|TWO_SIDED|95.0|-0.266|-0.014|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||-0.014|-0.266|0.0304
74070718|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.084|STANDARD_ERROR_OF_MEAN|0.15||0.5811|TWO_SIDED|95.0|-0.384|0.217|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.217|-0.384|0.5811
74070719|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.098|STANDARD_ERROR_OF_MEAN|0.06||0.1144|TWO_SIDED|95.0|-0.22|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.024|-0.220|0.1144
74070720|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.109|STANDARD_ERROR_OF_MEAN|0.12||0.3774|TWO_SIDED|95.0|-0.352|0.135|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.135|-0.352|0.3774
74070721|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|0.057|STANDARD_ERROR_OF_MEAN|0.34||0.8658|TWO_SIDED|95.0|-0.613|0.727|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.727|-0.613|0.8658
74070722|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|0.018|STANDARD_ERROR_OF_MEAN|0.1||0.8543|TWO_SIDED|95.0|-0.179|0.216|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.216|-0.179|0.8543
74070723|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.153|STANDARD_ERROR_OF_MEAN|0.19||0.4294|TWO_SIDED|95.0|-0.537|0.231|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.231|-0.537|0.4294
74070724|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.113|STANDARD_ERROR_OF_MEAN|0.12||0.3613|TWO_SIDED|95.0|-0.357|0.132|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.132|-0.357|0.3613
74070725|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.047|STANDARD_ERROR_OF_MEAN|0.13||0.7201|TWO_SIDED|95.0|-0.305|0.212|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation||0.212|-0.305|0.7201
74070726|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.213|STANDARD_ERROR_OF_MEAN|0.12||0.0767|TWO_SIDED|95.0|-0.448|0.023|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||0.023|-0.448|0.0767
74070727|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.216|STANDARD_ERROR_OF_MEAN|0.19||0.2618|TWO_SIDED|95.0|-0.597|0.165|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.165|-0.597|0.2618
74070728|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.16||0.7633|TWO_SIDED|95.0|-0.366|0.269|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.269|-0.366|0.7633
74070729|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.198|STANDARD_ERROR_OF_MEAN|0.15||0.1968|TWO_SIDED|95.0|-0.502|0.105|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.105|-0.502|0.1968
74070730|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.12||0.6891|TWO_SIDED|95.0|-0.296|0.197|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities||0.197|-0.296|0.6891
74070731|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.171|STANDARD_ERROR_OF_MEAN|0.14||0.2229|TWO_SIDED|95.0|-0.447|0.106|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.106|-0.447|0.2229
74070732|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.072|STANDARD_ERROR_OF_MEAN|0.06||0.2591|TWO_SIDED|95.0|-0.197|0.054|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||0.054|-0.197|0.2591
74070733|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.15||0.7099|TWO_SIDED|95.0|-0.359|0.246|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.246|-0.359|0.7099
74070734|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.031|STANDARD_ERROR_OF_MEAN|0.06||0.6215|TWO_SIDED|95.0|-0.154|0.092|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.092|-0.154|0.6215
74070735|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.12||0.6422|TWO_SIDED|95.0|-0.302|0.187|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.187|-0.302|0.6422
74070736|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.483|STANDARD_ERROR_OF_MEAN|0.34||0.1574|TWO_SIDED|95.0|-1.157|0.19|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.190|-1.157|0.1574
74070737|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.1||0.4039|TWO_SIDED|95.0|-0.115|0.282|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.282|-0.115|0.4039
74070738|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.309|STANDARD_ERROR_OF_MEAN|0.19||0.1145|TWO_SIDED|95.0|-0.695|0.076|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.076|-0.695|0.1145
74070739|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.127|STANDARD_ERROR_OF_MEAN|0.12||0.3083|TWO_SIDED|95.0|-0.372|0.119|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.119|-0.372|0.3083
74070740|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.183|STANDARD_ERROR_OF_MEAN|0.13||0.1638|TWO_SIDED|95.0|-0.443|0.0776|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation||0.0776|-0.443|0.1638
74070741|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.078|STANDARD_ERROR_OF_MEAN|0.12||0.5101|TWO_SIDED|95.0|-0.314|0.157|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||0.157|-0.314|0.5101
73883514|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.392||||0.0005|TWO_SIDED|95.0|0.604|2.18|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.180|0.604|0.0005
73883515|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.386||||0.0012|TWO_SIDED|95.0|0.547|2.225|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.225|0.547|0.0012
73883516|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.383||||0.0018|TWO_SIDED|95.0|0.514|2.252|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.252|0.514|0.0018
73883517|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.376||||0.0035|TWO_SIDED|95.0|0.451|2.301|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.301|0.451|0.0035
74070742|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.233|STANDARD_ERROR_OF_MEAN|0.19||0.2285|TWO_SIDED|95.0|-0.614|0.149|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.149|-0.614|0.2285
74070743|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.16||0.4612|TWO_SIDED|95.0|-0.2|0.436|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.436|-0.200|0.4612
74070744|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|0.099|STANDARD_ERROR_OF_MEAN|0.15||0.519|TWO_SIDED|95.0|-0.205|0.402|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.402|-0.205|0.5190
74070745|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|0.12||0.8479|TWO_SIDED|95.0|-0.271|0.223|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities||0.223|-0.271|0.8479
74070746|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.039|STANDARD_ERROR_OF_MEAN|0.14||0.7808|TWO_SIDED|95.0|-0.316|0.238|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.238|-0.316|0.7808
74070747|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.171|STANDARD_ERROR_OF_MEAN|0.06||0.0083|TWO_SIDED|95.0|-0.296|-0.045|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||-0.045|-0.296|0.0083
74070748|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.101|STANDARD_ERROR_OF_MEAN|0.15||0.5068|TWO_SIDED|95.0|-0.404|0.201|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.201|-0.404|0.5068
73883518|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.373||||0.0049|TWO_SIDED|95.0|0.416|2.33|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.330|0.416|0.0049
74070749|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.068|STANDARD_ERROR_OF_MEAN|0.06||0.2725|TWO_SIDED|95.0|-0.191|0.055|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.055|-0.191|0.2725
74070750|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|0.039|STANDARD_ERROR_OF_MEAN|0.12||0.7498|TWO_SIDED|95.0|-0.206|0.284|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.284|-0.206|0.7498
74070751|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|0.152|STANDARD_ERROR_OF_MEAN|0.34||0.6554|TWO_SIDED|95.0|-0.522|0.826|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.826|-0.522|0.6554
74070752|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.1||0.4143|TWO_SIDED|95.0|-0.116|0.28|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.280|-0.116|0.4143
74070753|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.055|STANDARD_ERROR_OF_MEAN|0.19||0.7761|TWO_SIDED|95.0|-0.441|0.33|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.330|-0.441|0.7761
74070754|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.12||0.9697|TWO_SIDED|95.0|-0.241|0.251|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.251|-0.241|0.9697
74070755|NCT03179345|147693268|SUPERIORITY||Mean Difference (Net)|-0.086|STANDARD_ERROR_OF_MEAN|0.13||0.5118|TWO_SIDED|95.0|-0.346|0.174|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.||Motivation|SE of difference estimated by dividing width of 95% CI by 4.|0.174|-0.346|0.5118
74070756|NCT03179345|147693269|SUPERIORITY||Mean Difference (Net)|-0.116|STANDARD_ERROR_OF_MEAN|0.53||0.8293|TWO_SIDED|95.0|-1.178|0.947|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.947|-1.178|0.8293
74070757|NCT03179345|147693269|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.53||0.9705|TWO_SIDED|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.049|-1.089|0.9705
74070758|NCT03179345|147693270|SUPERIORITY||Mean Difference (Net)|-0.488|STANDARD_ERROR_OF_MEAN|0.53||0.3666|TWO_SIDED|95.0|-1.556|0.581|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.581|-1.556|0.3666
74070759|NCT03179345|147693270|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.53||0.9705|TWO_SIDED|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.049|-1.089|0.9705
74070760|NCT02300025|147693325|SUPERIORITY_OR_OTHER||LS means ratio|92.2|||||TWO_SIDED|90.0|59.2|143.4|||||The 90% CI for differences in LS means between test and reference treatments obtained from mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model analysis of variance (ANOVA) to determine 90% confidence interval (CI) of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The least squares (LS) means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||143.4|59.2|
74070761|NCT02300025|147693325|SUPERIORITY_OR_OTHER||LS means ratio|84.9|||||TWO_SIDED|90.0|54.6|132.1|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||132.1|54.6|
74070762|NCT02300025|147693325|SUPERIORITY_OR_OTHER||LS means ratio|39.0|||||TWO_SIDED|90.0|25.1|60.7|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||60.7|25.1|
74070763|NCT02300025|147693327|SUPERIORITY_OR_OTHER||LS means ratio|98.4|||||TWO_SIDED|90.0|52.0|186.0|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||186.0|52.0|
74070764|NCT02300025|147693327|SUPERIORITY_OR_OTHER||LS means ratio|102.2|||||TWO_SIDED|90.0|54.0|193.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||193.2|54.0|
74070765|NCT02300025|147693327|SUPERIORITY_OR_OTHER||LS means ratio|42.5|||||TWO_SIDED|90.0|22.5|80.5|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||80.5|22.5|
74070766|NCT02300025|147693328|SUPERIORITY_OR_OTHER||LS means ratio|97.6|||||TWO_SIDED|90.0|59.3|160.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||160.6|59.3|
73883519|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.367||||0.0084|TWO_SIDED|95.0|0.35|2.383|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.383|0.350|0.0084
73888345|NCT01746901|147309550|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.5092|TWO_SIDED|95.0|-2.1|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.0|-2.1|0.5092
74070767|NCT02300025|147693328|SUPERIORITY_OR_OTHER||LS means ratio|103.0|||||TWO_SIDED|90.0|62.6|169.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||169.6|62.6|
74070768|NCT02300025|147693328|SUPERIORITY_OR_OTHER||LS means ratio|68.5|||||TWO_SIDED|90.0|40.4|116.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||116.2|40.4|
74070769|NCT00780026|147693334|SUPERIORITY_OR_OTHER|||||||0.841||||||P value for Bacterial infection|Chi-squared|||||||0.841
74070770|NCT00780026|147693334|SUPERIORITY_OR_OTHER|||||||0.298||||||P-value for fungal infection|Chi-squared|||||||0.298
74070771|NCT00780026|147693334|SUPERIORITY_OR_OTHER|||||||0.585||||||P value for transplant incision wound|Chi-squared|||||||0.585
74070772|NCT00780026|147693334|SUPERIORITY_OR_OTHER|||||||0.505||||||P value for viral infection|Chi-squared|||||||0.505
74070773|NCT00780026|147693335|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||||||0.999
74070774|NCT00780026|147693336|EQUIVALENCE|If the p-value for the means is \> 0.05 between the groups then they will be deemed equivalent.||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
73883520|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.363||||0.011|TWO_SIDED|95.0|0.313|2.414|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.414|0.313|0.0110
73883521|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.357||||0.0168|TWO_SIDED|95.0|0.245|2.47|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.470|0.245|0.0168
73883522|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.354||||0.0208|TWO_SIDED|95.0|0.206|2.501|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.501|0.206|0.0208
73883523|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.348||||0.0293|TWO_SIDED|95.0|0.136|2.559|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.559|0.136|0.0293
73883524|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.344||||0.0348|TWO_SIDED|95.0|0.096|2.592|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.592|0.096|0.0348
73883525|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.338||||0.0459|TWO_SIDED|95.0|0.024|2.652|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.652|0.024|0.0459
73883526|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.335||||0.0528|TWO_SIDED|95.0|-0.016|2.685|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.685|-0.016|0.0528
73883527|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.328||||0.0663|TWO_SIDED|95.0|-0.09|2.746|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.746|-0.090|0.0663
73883528|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.325||||0.0744|TWO_SIDED|95.0|-0.131|2.78|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.780|-0.131|0.0744
74070775|NCT00780026|147693338|SUPERIORITY_OR_OTHER|||||||0.401|||||||Fisher Exact|||||||0.401
74070776|NCT00780026|147693339|SUPERIORITY_OR_OTHER|||||||0.826||||||P value for bile leak|Chi-squared|||||||0.826
74070777|NCT00780026|147693339|SUPERIORITY_OR_OTHER|||||||0.137||||||This is the p value for Biliary Stricture|Chi-squared|||||||0.137
74070778|NCT00780026|147693340|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||||||0.999
74070779|NCT03522948|147693342|SUPERIORITY||Mean Difference (Net)|-3.16|STANDARD_DEVIATION|-0.71||0.03|TWO_SIDED||||||t-test, 2 sided|||within-subject t-test||||.03
74070780|NCT03522948|147693343|SUPERIORITY||t-test|-1.34|STANDARD_DEVIATION|3.2||0.23|TWO_SIDED||||||t-test, 2 sided||||d = -0.51|||0.23
74070781|NCT03522948|147693344|SUPERIORITY||t-test|1.35|||<|0.05|TWO_SIDED|95.0|-0.69|2.41|||t-test, 2 sided|||GSAB self-efficacy||2.41|-0.69|<.05
74070782|NCT03522948|147693345|SUPERIORITY||t-test|2.93|||<|0.05|TWO_SIDED|95.0|0.31|3.41|||t-test, 2 sided|||Test of GSAB self-efficacy subscale for condom use||3.41|0.31|<.05
74070783|NCT01816477|147693362|SUPERIORITY_OR_OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
74070784|NCT01816477|147693363|SUPERIORITY_OR_OTHER|||||||0.0872|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.||||0.0872
74070785|NCT01816477|147693363|SUPERIORITY_OR_OTHER|||||||0.6751|||||||Unequal Variance T-Test|||Comparison between groups for day 2.||||0.6751
74070786|NCT01816477|147693363|SUPERIORITY_OR_OTHER|||||||0.1203|||||||Unequal Variance T-Test|||Comparison between groups for day 3.||||0.1203
74070787|NCT01816477|147693363|SUPERIORITY_OR_OTHER|||||||0.3582|||||||Unequal Variance T-Test|||Comparison between groups for day 4.||||0.3582
74070788|NCT01816477|147693363|SUPERIORITY_OR_OTHER|||||||0.0625|||||||Unequal Variance T-Test|||Comparison between groups for day 5||||0.0625
74070789|NCT01816477|147693363|SUPERIORITY_OR_OTHER|||||||0.0484|||||||Unequal Variance T-Test|||Comparison between groups for day 6.||||0.0484
74070790|NCT01816477|147693364|SUPERIORITY_OR_OTHER|||||||0.6465|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.||||0.6465
74070791|NCT01816477|147693364|SUPERIORITY_OR_OTHER|||||||0.9233|||||||Unequal Variance T-Test|||Comparison between groups for day 2.||||0.9233
74070792|NCT01816477|147693364|SUPERIORITY_OR_OTHER|||||||0.5788|||||||Unequal Variance T-Test|||Comparison between groups for day 3.||||0.5788
74070793|NCT01816477|147693364|SUPERIORITY_OR_OTHER|||||||0.1036|||||||Unequal Variance T-Test|||Comparison between the groups for day 4.||||0.1036
74070794|NCT01816477|147693364|SUPERIORITY_OR_OTHER|||||||0.5314|||||||Unequal Variance T-Test|||Comparison between groups for day 5.||||0.5314
73883529|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.319||||0.0898|TWO_SIDED|95.0|-0.205|2.842|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.842|-0.205|0.0898
73883530|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.315||||0.0988|TWO_SIDED|95.0|-0.246|2.877|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.877|-0.246|0.0988
74070795|NCT01816477|147693364|SUPERIORITY_OR_OTHER|||||||0.7166|||||||Unequal Variance T-Test|||Comparison between groups for day 6.||||0.7166
74070796|NCT01047345|147693368|SUPERIORITY_OR_OTHER||Difference in Percentages|3.5||||0.026|TWO_SIDED|95.0|0.5|6.2|||Miettinen & Nurminen|||||6.2|0.5|0.026
74070797|NCT01047345|147693369|SUPERIORITY_OR_OTHER||Difference in Percentages|4.0|||||TWO_SIDED|95.0|-2.8|10.8|||Miettinen & Nurminen|||||10.8|-2.8|
74070798|NCT01047345|147693370|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-1.5|0.9|||Miettinen & Nurminen|||||0.9|-1.5|
74070799|NCT01047345|147693371|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.2|||||TWO_SIDED|95.0|-1.7|0.6|||Miettinen & Nurminen|||||0.6|-1.7|
74070800|NCT01047345|147693372|SUPERIORITY_OR_OTHER||Difference in Percentages|10.2|||||TWO_SIDED|95.0|7.5|13.1|||Miettinen & Nurminen|||||13.1|7.5|
74070801|NCT01047345|147693373|SUPERIORITY_OR_OTHER||Seroconversion rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% confidence interval (CI) for the proportion of participants seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 31||100.0|98.9|<0.001
74070802|NCT01047345|147693373|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 33||100.0|98.9|<0.001
74070803|NCT01047345|147693373|SUPERIORITY_OR_OTHER||Seroconversion Rate|98.3|||<|0.001|TWO_SIDED|95.0|96.7|99.2||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 45||99.2|96.7|<0.001
74070804|NCT01047345|147693373|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.6|||<|0.001|TWO_SIDED|95.0|98.6|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 52||100.0|98.6|<0.001
74070805|NCT01047345|147693373|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 58||100.0|98.9|<0.001
74070806|NCT00108732|147693407|SUPERIORITY_OR_OTHER||Percent|62.5|||||TWO_SIDED|90.0|48.3|75.3||||||||75.3|48.3|
74070807|NCT00108732|147693408|SUPERIORITY_OR_OTHER||Response rate (percent)|0.0|||||TWO_SIDED|90.0|0.0|7.2||||||||7.2|0|
74070808|NCT00108732|147693409|SUPERIORITY_OR_OTHER||median of difference|0.45||||0.003||95.0|||||Wilcoxon signed rank test|The Wilcoxon signed rank test was used to test the difference between day 4 PSA and day 15 PSA.||||||0.003
74070809|NCT00108732|147693410|SUPERIORITY_OR_OTHER||median of difference|-0.04||||0.02||95.0||||The Wilcoxon signed-rank test was used to test the difference between pre and post-treatment PSA slopes assessed by multiple PSA values on natural log scale using a piecewise linear model with a common knot point at the date of registration.|Wilcoxon signed rank test|||||||0.02
74070810|NCT00698685|147693420|SUPERIORITY_OR_OTHER||actuarial probability of engraftment|70.0||||||95.0|||||||Actuarial probability of engraftment at day +100 is calculated according to the product-limit estimate method.|||||
74070811|NCT00282256|147693422|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for AUC0-24 was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|100.9|||||TWO_SIDED|90.0|90.8|112.1|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||112.1|90.8|
74070812|NCT00282256|147693424|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for Cmin was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|91.8|||||TWO_SIDED|90.0|82.6|102.2|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||102.2|82.6|
74070813|NCT00329602|147693464|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for Week 12.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.||||||0.039
74070814|NCT00329602|147693464|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value is for Week 26.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.||||||0.023
74070815|NCT00455533|147693479|SUPERIORITY_OR_OTHER|||||||0.8921||95.0|||||Fisher Exact|||||||0.8921
74070816|NCT00455533|147693479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8966|TWO_SIDED|90.0|0.6|1.55|||Cochran-Mantel-Haenszel|||||1.55|0.60|0.8966
73883531|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.309||||0.1156|TWO_SIDED|95.0|-0.321|2.94|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.940|-0.321|0.1156
73883532|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.306||||0.1252|TWO_SIDED|95.0|-0.363|2.975|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.975|-0.363|0.1252
73883533|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.1429|TWO_SIDED|95.0|-0.439|3.038|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.038|-0.439|0.1429
73883534|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.296||||0.1529|TWO_SIDED|95.0|-0.481|3.074|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.074|-0.481|0.1529
74070817|NCT00455533|147693479|SUPERIORITY_OR_OTHER||difference in pCR|-0.6|||||TWO_SIDED|95.0|-7.9|6.7|||||The difference in pCR rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.|||6.7|-7.9|
74070818|NCT00455533|147693482|SUPERIORITY_OR_OTHER|||||||0.6186||95.0|||||Fisher Exact|||||||0.6186
74070819|NCT00455533|147693482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.5806|TWO_SIDED|90.0|0.56|1.34|||Cochran-Mantel-Haenszel|||||1.34|0.56|0.5806
74070820|NCT00455533|147693482|SUPERIORITY_OR_OTHER||difference|-2.5|||||TWO_SIDED|90.0|-11.0|6.0|||||The difference in pCR/RCB-I rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.|||6.0|-11|
74070821|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.4115||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 (209993\_at)||||0.4115
74070822|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1629||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.1629
74070823|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.5074||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5074
74070824|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.553||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.5530
74070825|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1845||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.1845
74070826|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.3538||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.3538
74070827|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.9751||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.9751
74070828|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.8874||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.8874
74070829|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.6907||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.6907
74070830|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.8052||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.8052
74070831|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.5031||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.5031
74070832|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.7588||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.7588
74070833|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1542||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.1542
74070834|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.0235||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0235
74070835|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.3612||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.3612
74070836|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.184||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.1840
74070837|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.0942||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0942
74070838|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.5327||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.5327
74070839|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.8847||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8847
74070840|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.8947||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8947
74070841|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.4085||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.4085
74070842|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1119||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.1119
74070843|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0250
74070844|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.3569||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.3569
74070845|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.4103||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.4103
74070846|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.1490
74070847|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.559||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.5590
74070848|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.4796||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.4796
74070849|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.2794||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.2794
74070850|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1646||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.1646
74070851|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.0782||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0782
74070852|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1407||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.1407
74070853|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.2369||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.2369
74070854|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.7756||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.7756
73883535|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.1711|TWO_SIDED|95.0|-0.558|3.138|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.138|-0.558|0.1711
73883536|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.287||||0.1813|TWO_SIDED|95.0|-0.6|3.173|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.173|-0.600|0.1813
73883537|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.1998|TWO_SIDED|95.0|-0.677|3.238|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.238|-0.677|0.1998
74070855|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.2623||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.2623
74070856|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.3147||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.3147
73883538|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.277||||0.21|TWO_SIDED|95.0|-0.72|3.273|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.273|-0.720|0.2100
73883539|NCT00083889|147300796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.271||||0.2283|TWO_SIDED|95.0|-0.797|3.338|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.338|-0.797|0.2283
73883540|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.214|||<|0.0001|TWO_SIDED|95.0|0.719|1.708|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Social/Family Well Being (SWB) subscale baseline score (intercept and time since randomization are included as random effects).||1.708|0.719|<.0001
73883541|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.216|||<|0.0001|TWO_SIDED|95.0|0.729|1.703|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.703|0.729|<.0001
74070857|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.2885||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.2885
73883542|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.217|||<|0.0001|TWO_SIDED|95.0|0.731|1.704|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.704|0.731|<.0001
73883543|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|||<|0.0001|TWO_SIDED|95.0|0.73|1.71|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.710|0.730|<.0001
74070858|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.7187||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.7187
73883544|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.221|||<|0.0001|TWO_SIDED|95.0|0.727|1.716|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.716|0.727|<.0001
74070859|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.6017||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.6017
73883545|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.224|||<|0.0001|TWO_SIDED|95.0|0.716|1.732|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.732|0.716|<.0001
73883546|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.225|||<|0.0001|TWO_SIDED|95.0|0.707|1.744|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.744|0.707|<.0001
73883547|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.228|||<|0.0001|TWO_SIDED|95.0|0.687|1.769|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.769|0.687|<.0001
73883548|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.229|||<|0.0001|TWO_SIDED|95.0|0.673|1.785|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.785|0.673|<.0001
73883549|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.232|||<|0.0001|TWO_SIDED|95.0|0.646|1.818|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.818|0.646|<.0001
74070860|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.4500
74070861|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.0952||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.0952
73883550|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.233|||<|0.0001|TWO_SIDED|95.0|0.629|1.838|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.838|0.629|<.0001
74070862|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.7069||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.7069
74070863|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.4767||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.4767
74070864|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.6191||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.6191
74070865|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.5276||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.5276
74070866|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.3323||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.3323
74070867|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1025||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1025
74070868|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1715||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1715
74070869|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.1070
74070870|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.2751||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.2751
73883551|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.236||||0.0002|TWO_SIDED|95.0|0.595|1.876|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.876|0.595|0.0002
73883552|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.237||||0.0003|TWO_SIDED|95.0|0.575|1.899|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.899|0.575|0.0003
73883553|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.0005|TWO_SIDED|95.0|0.537|1.942|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.942|0.537|0.0005
73883554|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.241||||0.0008|TWO_SIDED|95.0|0.515|1.967|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.967|0.515|0.0008
73883555|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.244||||0.0015|TWO_SIDED|95.0|0.474|2.013|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.013|0.474|0.0015
73883556|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.245||||0.0021|TWO_SIDED|95.0|0.45|2.04|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.040|0.450|0.0021
73883557|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.248||||0.0037|TWO_SIDED|95.0|0.406|2.089|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.089|0.406|0.0037
73883558|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.249||||0.0048|TWO_SIDED|95.0|0.382|2.116|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.116|0.382|0.0048
73883559|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.251||||0.0074|TWO_SIDED|95.0|0.336|2.167|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.167|0.336|0.0074
73883560|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.253||||0.0092|TWO_SIDED|95.0|0.31|2.196|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.196|0.310|0.0092
74070871|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.0276||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0276
74070872|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1689||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1689
74070873|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.0769||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.0769
74070874|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1058||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1058
73883561|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.255||||0.0132|TWO_SIDED|95.0|0.262|2.248|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.248|0.262|0.0132
74070875|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.6406||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.6406
74070876|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1733||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.1733
74070877|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.2631||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2631
74070878|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.2170
73883562|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.257||||0.0159|TWO_SIDED|95.0|0.236|2.278|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.278|0.236|0.0159
73883563|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.259||||0.0213|TWO_SIDED|95.0|0.187|2.332|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.332|0.187|0.0213
73883564|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.261||||0.0248|TWO_SIDED|95.0|0.16|2.362|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.362|0.160|0.0248
73883565|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263||||0.0318|TWO_SIDED|95.0|0.11|2.416|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.416|0.110|0.0318
73883566|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.265||||0.036|TWO_SIDED|95.0|0.083|2.447|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.447|0.083|0.0360
73883567|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.267||||0.0443|TWO_SIDED|95.0|0.032|2.502|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.502|0.032|0.0443
73883568|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.269||||0.0493|TWO_SIDED|95.0|0.004|2.533|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.533|0.004|0.0493
73883569|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.271||||0.0587|TWO_SIDED|95.0|-0.047|2.589|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.589|-0.047|0.0587
73883570|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.273||||0.0642|TWO_SIDED|95.0|-0.075|2.62|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.620|-0.075|0.0642
73883571|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.275||||0.0746|TWO_SIDED|95.0|-0.127|2.677|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.677|-0.127|0.0746
74070879|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.0868||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.0868
74070880|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1117||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.1117
73883572|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.276||||0.0806|TWO_SIDED|95.0|-0.155|2.708|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.708|-0.155|0.0806
73883573|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.279||||0.0917|TWO_SIDED|95.0|-0.207|2.765|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.765|-0.207|0.0917
74070881|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.4943||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 (208601\_s\_at)||||0.4943
74070882|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.5190
74070883|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.735||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.7350
74070884|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.3820
74070885|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.9290
74070886|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.0699||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.0699
74070887|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.3515||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.3515
74070888|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.2128||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.2128
74070889|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1275||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.1275
74070890|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.2158||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.2158
74070891|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.0266||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.0266
74070892|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.3636||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.3636
74070893|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.9479||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.9479
74070894|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.3753||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.3753
74070895|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.5477||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.5477
74070896|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.476||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.4760
74070897|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.3314||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.3314
74070898|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.1005||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.1005
74070899|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1180
73883574|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.098|TWO_SIDED|95.0|-0.236|2.797|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.797|-0.236|0.0980
73883575|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.283||||0.1095|TWO_SIDED|95.0|-0.288|2.854|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.854|-0.288|0.1095
73883576|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.284||||0.1161|TWO_SIDED|95.0|-0.318|2.886|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.886|-0.318|0.1161
73883577|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.287||||0.128|TWO_SIDED|95.0|-0.37|2.944|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.944|-0.370|0.1280
73883578|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.288||||0.1346|TWO_SIDED|95.0|-0.399|2.976|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.976|-0.399|0.1346
73883579|NCT00083889|147300797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.291||||0.1466|TWO_SIDED|95.0|-0.452|3.034|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||3.034|-0.452|0.1466
73883580|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.929||||0.0001|TWO_SIDED|95.0|0.46|1.398|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Emotional Well Being (EWB) subscale baseline score (intercept and time since randomization are included as random effects).||1.398|0.460|0.0001
73883581|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.922|||<|0.0001||95.0|0.469|1.375|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.375|0.469|<.0001
73883582|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.918|||<|0.0001||95.0|0.471|1.365|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.365|0.471|<.0001
73883583|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.911|||<|0.0001||95.0|0.469|1.352|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.352|0.469|<.0001
74070900|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1580
73883584|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.907|||<|0.0001||95.0|0.466|1.348|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.348|0.466|<.0001
73883585|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.899|||<|0.0001||95.0|0.453|1.345|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.345|0.453|<.0001
74070901|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.4385||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.4385
74070902|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.7324||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.7324
74070903|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.2657||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.2657
74070904|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.5637||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.5637
73883586|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.895||||0.0001||95.0|0.444|1.347|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.347|0.444|0.0001
73883587|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.888||||0.0002||95.0|0.421|1.355|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.355|0.421|0.0002
73883588|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.884||||0.0003||95.0|0.406|1.362|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.362|0.406|0.0003
73883589|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.877||||0.0006||95.0|0.375|1.379|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.379|0.375|0.0006
73883590|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.873||||0.0009||95.0|0.356|1.39|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.390|0.356|0.0009
73883591|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.866||||0.002||95.0|0.318|1.414|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.414|0.318|0.0020
74070905|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.4473||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.4473
74070906|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.3292||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.3292
74070907|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.2054||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.2054
74070908|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.5226||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.5226
74070909|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.172||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.1720
73883592|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.862||||0.0029||95.0|0.295|1.428|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.428|0.295|0.0029
73883593|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.854||||0.0055||95.0|0.251|1.457|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.457|0.251|0.0055
73883594|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.0076||95.0|0.226|1.475|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.475|0.226|0.0076
74070910|NCT00455533|147693483|SUPERIORITY_OR_OTHER|||||||0.3346||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.3346
74070911|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.5604||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5604
74070912|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2715||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.2715
74070913|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.5268||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5268
74070914|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.6058||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.6058
73883595|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.843||||0.0129||95.0|0.179|1.508|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.508|0.179|0.0129
73883596|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.839||||0.0168||95.0|0.151|1.527|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.527|0.151|0.0168
73883597|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.832||||0.0257||95.0|0.101|1.563|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.563|0.101|0.0257
74070915|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1918||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.1918
74070916|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.6712||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.6712
74070917|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.9195||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.9195
74070918|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.7021||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.7021
74070919|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.3910
74070920|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2909||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.2909
74070921|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.3336||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.3336
74070922|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.2360
74070923|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0281||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0281
74070924|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0434||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0434
74070925|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0283||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0283
74070926|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0151||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0151
74070927|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1999||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.1999
74070928|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0146||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0146
73883598|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.828||||0.0318||95.0|0.072|1.583|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.583|0.072|0.0318
73883599|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.821||||0.0447||95.0|0.019|1.622|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.622|0.019|0.0447
73883600|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.817||||0.0529||95.0|-0.01|1.643|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.643|-0.010|0.0529
74070929|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1185||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.1185
74070930|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.8705||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8705
74070931|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0284||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.0284
74070932|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0399||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0399
74070933|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0136||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0136
74070934|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0576||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0576
74070935|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2245||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.2245
74070936|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1388||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.1388
74070937|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0692||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.0692
74070938|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1058||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.1058
73883601|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.809||||0.0696||95.0|-0.065|1.683|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.683|-0.065|0.0696
74070939|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2688||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.2688
74070940|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0192||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.0192
74070941|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0033||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0033
74070942|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2053||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.2053
74070943|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0032||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0032
74070944|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.6783||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.6783
73883602|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.805||||0.0797||95.0|-0.095|1.706|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.706|-0.095|0.0797
73883603|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.798||||0.0994||95.0|-0.151|1.747|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.747|-0.151|0.0994
73883604|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.794||||0.111||95.0|-0.182|1.77|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.770|-0.182|0.1110
73883605|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.787||||0.1328||95.0|-0.239|1.813|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.813|-0.239|0.1328
73883606|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.783||||0.1454||95.0|-0.271|1.836|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.836|-0.271|0.1454
74070945|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.1630
74070946|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2944||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.2944
74070947|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.3727||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.3727
74070948|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.8796||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.8796
74070949|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.8344||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.8344
74070950|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.2700
74070951|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2624||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.2624
74070952|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.0830
73883607|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.776||||0.1686||95.0|-0.329|1.88|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.880|-0.329|0.1686
73883608|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.771||||0.1817||95.0|-0.361|1.904|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.904|-0.361|0.1817
74070953|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0849||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.0849
73883609|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764||||0.2055||95.0|-0.419|1.948|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.948|-0.419|0.2055
74070954|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.6578||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.6578
74070955|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0396||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.0396
73883610|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76||||0.2188||95.0|-0.452|1.972|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.972|-0.452|0.2188
73883611|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.753||||0.2427||95.0|-0.51|2.016|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.016|-0.510|0.2427
74070956|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1657||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1657
74070957|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0675||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.0675
74070958|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1071||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1071
74070959|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0142||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0142
74070960|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2465||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.2465
74070961|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0031||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0031
74070962|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1231||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1231
74070963|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0849||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.0849
74070964|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.2740
74070965|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2383||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2383
74070966|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0644||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.0644
74070967|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2866||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2866
74070968|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1259||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.1259
74070969|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0718||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.0718
74070970|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.3170
74070971|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.7844||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.7844
74070972|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.4688||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.4688
74070973|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.8553||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.8553
73883612|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.749||||0.2559||95.0|-0.543|2.041|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.041|-0.543|0.2559
73883613|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.742||||0.2794||95.0|-0.602|2.086|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.086|-0.602|0.2794
73883614|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.738||||0.2923||95.0|-0.635|2.111|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.111|-0.635|0.2923
73883615|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.3152||95.0|-0.695|2.156|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.156|-0.695|0.3152
73883616|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.726||||0.3276||95.0|-0.728|2.181|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.181|-0.728|0.3276
73883617|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.719||||0.3497||95.0|-0.788|2.227|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.227|-0.788|0.3497
73883618|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.715||||0.3616||95.0|-0.822|2.252|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.252|-0.822|0.3616
73883619|NCT00083889|147300798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.708||||0.3827||95.0|-0.882|2.298|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.298|-0.882|0.3827
74070974|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.6926||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.6926
74070975|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2222||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.2222
74070976|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.4676||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.4676
73883620|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.897|||<|0.0001|TWO_SIDED|95.0|1.261|2.533|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Functional Well Being (FWB) subscale baseline score (intercept and time since randomization are included as random effects).||2.533|1.261|<.0001
73883621|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.924|||<|0.0001||95.0|1.309|2.539|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.539|1.309|<.0001
73883622|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.939|||<|0.0001||95.0|1.331|2.546|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.546|1.331|<.0001
73883623|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.965|||<|0.0001||95.0|1.363|2.568|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.568|1.363|<.0001
74070977|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2036||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.2036
74070978|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.4197||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.4197
74070979|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0776||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.0776
74070980|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.4076||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.4076
74070981|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0629||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.0629
74070982|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2547||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.2547
74070983|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.7125||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.7125
74070984|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.6001||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.6001
74070985|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.5398||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.5398
74070986|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.3970
74070987|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.5085||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.5085
74070988|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1213||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.1213
74070989|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0999||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.0999
74070990|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1201||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1201
74070991|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.1172||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1172
74070992|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.6596||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.6596
74070993|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.3289||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.3289
74070994|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.3657||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.3657
74070995|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0275||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.0275
74070996|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.3946||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.3946
74070997|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.0074
74070998|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2341||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.2341
74070999|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.0933||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.0933
74071000|NCT00455533|147693484|SUPERIORITY_OR_OTHER|||||||0.2016||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.2016
74071001|NCT00455533|147693485|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.145|||||TWO_SIDED|90.0|-0.27|-0.017|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status||-0.017|-0.27|
74071002|NCT00455533|147693485|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.064|||||TWO_SIDED|90.0|-0.064|0.197|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker STatus||0.197|-0.064|
74071003|NCT00455533|147693485|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.056|||||TWO_SIDED|90.0|-0.152|0.046|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.046|-0.152|
74071004|NCT00455533|147693485|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.116|||||TWO_SIDED|90.0|-0.13|0.37|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status||0.37|-0.13|
74071005|NCT00455533|147693486|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.114|||||TWO_SIDED|90.0|-0.258|0.22|||||ixabepilone - paclitaxel|Mem+Cyto/Negative Biomarker Status||0.22|-0.258|
74071006|NCT00455533|147693486|SUPERIORITY_OR_OTHER||DIfference (bootstrap method)|0.009|||||TWO_SIDED|90.0|-0.137|0.155|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.155|-0.137|
74071007|NCT00455533|147693486|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.058|||||TWO_SIDED|90.0|-0.167|0.053|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.053|-0.167|
74071008|NCT00455533|147693486|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.049|||||TWO_SIDED|90.0|-0.227|0.309|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status||0.309|-0.227|
74071009|NCT00455533|147693487|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.29|||||TWO_SIDED|90.0|-0.482|-0.094|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status||-0.094|-0.482|
74071010|NCT00455533|147693487|SUPERIORITY_OR_OTHER||Difference (boostrap method)|0.106|||||TWO_SIDED|90.0|-0.073|0.291|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.291|-0.073|
74071011|NCT00455533|147693487|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.09|||||TWO_SIDED|90.0|-0.236|0.067|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.067|-0.236|
74071012|NCT00455533|147693487|SUPERIORITY_OR_OTHER||Difference (bootsrap method)|0.117|||||TWO_SIDED|90.0|-0.218|0.469|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.469|-0.218|
74071013|NCT01048333|147693531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.002|TWO_SIDED|95.0|1.31|3.35|||Regression, Cox|||||3.35|1.31|0.002
74071014|NCT01048333|147693531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.534||||0.001|TWO_SIDED|95.0|3.55|12.02|||Regression, Cox|||||12.02|3.55|0.001
74071015|NCT01048333|147693531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.127||||0.001|TWO_SIDED|95.0|1.77|5.52|||Regression, Cox|||||5.52|1.77|0.001
74071016|NCT01396044|147693533|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
74071017|NCT01396044|147693534|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.093
74071018|NCT01396044|147693535|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0|||||Chi-squared|||||||0.17
74071019|NCT01396044|147693536|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
74071020|NCT01396044|147693537|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.36
74071021|NCT01396044|147693539|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Chi-squared|||||||0.002
74071022|NCT03482713|147693546|OTHER||Difference in least squares means|0.79|||||TWO_SIDED|95.0|-0.34|1.93|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.|||1.93|-0.34|
74071023|NCT03482713|147693547|OTHER||Difference least squares mean|0.76|||||TWO_SIDED|95.0|-0.35|1.88|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.|||1.88|-0.35|
74071024|NCT01497938|147693548|NON_INFERIORITY_OR_EQUIVALENCE|pre-specified non-inferiority margin of 0.4% was used for sample size calculation. sample size is based on two-sample t test with one-sided type 1 error of 2.5%. Assuming a same mean of change in A1C for the treatment arm and control arm and a common standard deviation of 1% for both treatment groups, it showed that a total of 200 subjects will provide over 80% power to detect the non-inferiority with a margin of 0.4%|Mean Difference (Final Values)|0.05|||||ONE_SIDED|97.5||0.15|||ANCOVA|||||0.15||
74071025|NCT01497938|147693549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-588.0|||<|0.025||95.0|||||ANCOVA|||||||<0.025
74071026|NCT01691508|147693595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39||||0.008|TWO_SIDED|95.0|1.25|4.56|||Proportional odds model|||||4.56|1.25|0.008
74071027|NCT03238677|147693600|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.132|TWO_SIDED|95.0|-23.2|3.1|||Mixed Models Analysis|||Main effect of biofeedback at 10 weeks||3.1|-23.2|.132
74071028|NCT03238677|147693600|SUPERIORITY||Mean Difference (Final Values)|-13.7||||0.028|TWO_SIDED|95.0|-25.9|-1.5|||Mixed Models Analysis|||Main effect of Practice Distribution at 10 weeks||-1.5|-25.9|.028
73883624|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.98|||<|0.0001||95.0|1.376|2.584|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.584|1.376|<.0001
73883625|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.007|||<|0.0001||95.0|1.392|2.622|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.622|1.392|<.0001
73883626|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.022|||<|0.0001||95.0|1.396|2.647|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.647|1.396|<.0001
74071029|NCT03238677|147693600|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.187|TWO_SIDED|95.0|-24.9|5.0|||Mixed Models Analysis|||Main effect comparing telepractice vs face-to-face treatment||5.0|-24.9|.187
74071030|NCT03238677|147693600|SUPERIORITY||Mean Difference (Final Values)|20.22||||0.125|TWO_SIDED|95.0|-5.8|46.3|||Mixed Models Analysis|||Interaction of biofeedback and practice distribution at 10 weeks|η2 =.054|46.3|-5.8|.125
74071031|NCT00625807|147693615|OTHER||||||>|0.1||||||Cohen's d = 0.5|ANOVA|||ANOVA for group by time interaction||||> 0.1
74071032|NCT00625807|147693616|OTHER|||||||0.103|||||||ANOVA|||||||0.103
74071033|NCT00625807|147693617|OTHER|||||||0.022|||||||t-test, 2 sided|||within group change pre to week 8||||.022
74071034|NCT00625807|147693617|OTHER|within group change from pre to week 8|||||<|0.001|||||||t-test, 2 sided|||||||<.001
74071035|NCT00625807|147693618|OTHER|||||||0.015|||||||t-test, 2 sided|||within group change from pre to week 8||||.015
74071036|NCT00625807|147693618|OTHER|||||||0.53|||||||t-test, 2 sided|||within group change from pre to week 8||||.53
74071037|NCT00625807|147693619|OTHER|||||||0.06|||||||t-test, 2 sided|||within group change from pre to week 8||||.06
74071038|NCT00625807|147693619|OTHER||||||<|0.001|||||||t-test, 2 sided|||within group change from pre to post||||<.001
74071039|NCT01984242|147693641|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9819|TWO_SIDED|95.0|0.69|1.45|||Log Rank|||||1.45|0.69|0.9819
74071040|NCT01984242|147693641|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.358|TWO_SIDED|95.0|0.82|1.71|||Log Rank|||||1.71|0.82|0.3580
74071041|NCT01984242|147693643|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0952||95.0|0.38|1.08|||Log Rank|||||1.08|0.38|0.0952
74071042|NCT01984242|147693643|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9172|TWO_SIDED|95.0|0.63|1.67|||Log Rank|||||1.67|0.63|0.9172
74071043|NCT01984242|147693645|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0153|TWO_SIDED|95.0|0.26|0.87|||Log Rank|||||0.87|0.26|0.0153
74071044|NCT01984242|147693645|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.5545|TWO_SIDED|95.0|0.48|1.46|||Log Rank|||||1.46|0.48|0.5545
74071045|NCT01984242|147693647|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0086|TWO_SIDED|95.0|0.28|0.84|||Log Rank|||||0.84|0.28|0.0086
74071046|NCT01984242|147693647|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.7675||95.0|0.56|1.53|||Log Rank|||||1.53|0.56|0.7675
74071047|NCT01984242|147693649|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1973||95.0|0.44|1.18|||Log Rank|||||1.18|0.44|0.1973
74071048|NCT01984242|147693649|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.7738|TWO_SIDED|95.0|0.65|1.76|||Log Rank|||||1.76|0.65|0.7738
74071049|NCT01984242|147693651|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.083||95.0|0.43|1.06|||Log Rank|||||1.06|0.43|0.0830
74071050|NCT01984242|147693651|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7141|TWO_SIDED|95.0|0.7|1.69|||Log Rank|||||1.69|0.70|0.7141
74071051|NCT01984242|147693653|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2541||95.0|0.59|1.15|||Log Rank|||||1.15|0.59|0.2541
74071052|NCT01984242|147693653|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3103|TWO_SIDED|95.0|0.86|1.63|||Log Rank|||||1.63|0.86|0.3103
74071053|NCT01984242|147693655|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0351|TWO_SIDED|95.0|0.37|0.97|||Log Rank|||||0.97|0.37|0.0351
74071054|NCT01984242|147693655|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9769||95.0|0.64|1.54|||Log Rank|||||1.54|0.64|0.9769
74071055|NCT01984242|147693656|SUPERIORITY||Difference in response rates|2.97||||0.6492|TWO_SIDED|95.0|-10.68|16.62|||Cochran-Mantel-Haenszel|||||16.62|-10.68|0.6492
74071056|NCT01984242|147693656|SUPERIORITY||Difference in response rates|-3.47||||0.5433||95.0|-16.63|9.69|||Cochran-Mantel-Haenszel|||||9.69|-16.63|0.5433
74071057|NCT01984242|147693657|SUPERIORITY||Difference in response rates|19.33||||0.0141|TWO_SIDED|95.0|-0.28|38.94|||Cochran-Mantel-Haenszel|||||38.94|-0.28|0.0141
74071058|NCT01984242|147693657|SUPERIORITY||Difference in response rates|1.11||||0.8719|TWO_SIDED|95.0|-17.02|19.24|||Cochran-Mantel-Haenszel|||||19.24|-17.02|0.8719
74071059|NCT01984242|147693658|SUPERIORITY||Difference in response rates|1.98||||0.8068|TWO_SIDED|95.0|-12.04|16.0|||Cochran-Mantel-Haenszel|||||16.00|-12.04|0.8068
74071060|NCT01984242|147693658|SUPERIORITY||Difference in response rates|-9.37||||0.1321||95.0|-22.61|3.87|||Cochran-Mantel-Haenszel|||||3.87|-22.61|0.1321
74071061|NCT01984242|147693659|SUPERIORITY||Difference in response rates|19.67||||0.0199|TWO_SIDED|95.0|-0.1|39.44|||Cochran-Mantel-Haenszel|||||39.44|-0.10|0.0199
74071062|NCT01984242|147693659|SUPERIORITY||Difference in response rates|-2.41||||0.7836|TWO_SIDED|95.0|-20.5|15.68|||Cochran-Mantel-Haenszel|||||15.68|-20.50|0.7836
74071063|NCT01984242|147693660|SUPERIORITY||Difference in response rates|3.96||||0.6231|TWO_SIDED|95.0|-10.23|18.15|||Cochran-Mantel-Haenszel|||||18.15|-10.23|0.6231
74071064|NCT01984242|147693660|SUPERIORITY||Difference in response rates|-8.42||||0.1816|TWO_SIDED|95.0|-21.86|5.02|||Cochran-Mantel-Haenszel|||||5.02|-21.86|0.1816
74071065|NCT01984242|147693661|SUPERIORITY||Difference in response rates|22.0||||0.0111|TWO_SIDED|95.0|2.11|41.89|||Cochran-Mantel-Haenszel|||||41.89|2.11|0.0111
74071066|NCT01984242|147693661|SUPERIORITY||Difference in response rates|-2.22||||0.8209|TWO_SIDED|95.0|-20.63|16.19|||Cochran-Mantel-Haenszel|||||16.19|-20.63|0.8209
74071067|NCT01984242|147693663|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0863||95.0|0.5|1.05|||Log Rank|||||1.05|0.50|0.0863
74071068|NCT01984242|147693663|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5922|TWO_SIDED|95.0|0.77|1.57|||Log Rank|||||1.57|0.77|0.5922
74071069|NCT01984242|147693665|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.0021||95.0|0.25|0.75|||Log Rank|||||0.75|0.25|0.0021
74071070|NCT01984242|147693665|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6566|TWO_SIDED|95.0|0.56|1.44|||Log Rank|||||1.44|0.56|0.6566
74071071|NCT01984242|147693673|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.2867|TWO_SIDED|95.0|0.8|2.13|||Log Rank|||||2.13|0.80|0.2867
74071072|NCT01984242|147693673|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8039||95.0|0.65|1.73|||Log Rank|||||1.73|0.65|0.8039
74071073|NCT01984242|147693675|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.7879|TWO_SIDED|95.0|0.47|1.78|||Log Rank|||||1.78|0.47|0.7879
74071074|NCT01984242|147693675|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.9065|TWO_SIDED|95.0|0.52|1.8|||Log Rank|||||1.80|0.52|0.9065
74071075|NCT04543136|147693690|SUPERIORITY||Mean Difference (Final Values)|45.0||||0.074|TWO_SIDED|95.0|-4.5|94.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||94.5|-4.5|0.074
74071076|NCT04543136|147693690|SUPERIORITY||Mean Difference (Final Values)|58.8||||0.022|TWO_SIDED|95.0|8.5|109.1||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||109.1|8.5|0.022
74071077|NCT04543136|147693690|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.587|TWO_SIDED|95.0|-64.2|36.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||36.6|-64.2|0.587
74071078|NCT04543136|147693691|SUPERIORITY||Mean Difference (Final Values)|54.9||||0.03|TWO_SIDED|95.0|5.3|104.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||104.4|5.3|0.030
74071079|NCT04543136|147693691|SUPERIORITY||Mean Difference (Final Values)|61.8||||0.015|TWO_SIDED|95.0|12.5|111.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||111.2|12.5|0.015
74071080|NCT04543136|147693691|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.78|TWO_SIDED|95.0|-56.5|42.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||42.5|-56.5|0.780
74071081|NCT04543136|147693692|SUPERIORITY||Mean Difference (Final Values)|-13.3||||0.281|TWO_SIDED|95.0|-37.9|11.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||11.2|-37.9|0.281
74071082|NCT04543136|147693692|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.597|TWO_SIDED|95.0|-18.3|31.7||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||31.7|-18.3|0.597
74071083|NCT04543136|147693692|SUPERIORITY||Mean Difference (Final Values)|-20.0||||0.116|TWO_SIDED|95.0|-45.1|5.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||5.0|-45.1|0.116
74071084|NCT04543136|147693693|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.787|TWO_SIDED|95.0|-21.2|27.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||27.9|-21.2|0.787
74071085|NCT04543136|147693693|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.576|TWO_SIDED|95.0|-17.6|31.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||31.3|-17.6|0.576
73883627|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.048|||<|0.0001||95.0|1.397|2.7|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.700|1.397|<.0001
73883628|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.063|||<|0.0001||95.0|1.394|2.732|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.732|1.394|<.0001
73883629|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|||<|0.0001||95.0|1.383|2.797|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.797|1.383|<.0001
73883630|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.105|||<|0.0001||95.0|1.374|2.836|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.836|1.374|<.0001
73883631|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.132|||<|0.0001||95.0|1.353|2.91|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.910|1.353|<.0001
73883632|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.146|||<|0.0001||95.0|1.339|2.954|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.954|1.339|<.0001
73883633|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.173|||<|0.0001||95.0|1.311|3.036|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.036|1.311|<.0001
73883634|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.188|||<|0.0001||95.0|1.294|3.082|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.082|1.294|<.0001
73883635|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.215|||<|0.0001||95.0|1.26|3.169|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.169|1.260|<.0001
73883636|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23|||<|0.0001||95.0|1.241|3.219|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.219|1.241|<.0001
73883637|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.256|||<|0.0001||95.0|1.203|3.309|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.309|1.203|<.0001
73883638|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.271|||<|0.0001||95.0|1.182|3.361|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.361|1.182|<.0001
73883639|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.298|||<|0.0001||95.0|1.142|3.454|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.454|1.142|<.0001
73883640|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.313||||0.0001||95.0|1.119|3.507|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.507|1.119|0.0001
73883641|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.0003||95.0|1.076|3.603|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.603|1.076|0.0003
73883642|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.354||||0.0004||95.0|1.052|3.657|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.657|1.052|0.0004
73883643|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.381||||0.0007||95.0|1.008|3.754|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.754|1.008|0.0007
73883644|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.396||||0.0009||95.0|0.983|3.809|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.809|0.983|0.0009
73883645|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.423||||0.0014||95.0|0.938|3.908|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.908|0.938|0.0014
73883646|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.438||||0.0017||95.0|0.912|3.963|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.963|0.912|0.0017
73883647|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.464||||0.0025||95.0|0.866|4.063|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.063|0.866|0.0025
73883648|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.479||||0.003||95.0|0.84|4.119|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.119|0.840|0.0030
73883649|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.506||||0.0042||95.0|0.792|4.219|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.219|0.792|0.0042
73883650|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.521||||0.0049||95.0|0.766|4.275|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.275|0.766|0.0049
74071086|NCT04543136|147693693|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.775|TWO_SIDED|95.0|-28.1|21.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||21.0|-28.1|0.775
74071087|NCT04543136|147693694|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.766|TWO_SIDED|95.0|-0.7|0.52||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.52|-0.70|0.766
74071088|NCT04543136|147693694|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.032|TWO_SIDED|95.0|-1.3|-0.06||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.06|-1.30|0.032
74071089|NCT04543136|147693694|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.063|TWO_SIDED|95.0|-0.03|1.21||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.21|-0.03|0.063
74071090|NCT04543136|147693695|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.213|TWO_SIDED|95.0|-0.12|0.54||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.54|-0.12|0.213
74071091|NCT04543136|147693695|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.291|TWO_SIDED|95.0|-0.16|0.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.51|-0.16|0.291
74071092|NCT04543136|147693695|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.868|TWO_SIDED|95.0|-0.31|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-0.31|0.868
74071093|NCT04543136|147693696|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.661|TWO_SIDED|95.0|-0.35|0.55||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.55|-0.35|0.661
74071094|NCT04543136|147693696|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.218|TWO_SIDED|95.0|-0.75|0.17||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.17|-0.75|0.218
74071095|NCT04543136|147693696|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.1|TWO_SIDED|95.0|-0.08|0.85||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.85|-0.08|0.100
74071096|NCT04543136|147693697|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.701|TWO_SIDED|95.0|-0.8|0.54||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.54|-0.80|0.701
74071097|NCT04543136|147693697|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.438|TWO_SIDED|95.0|-0.96|0.42||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.42|-0.96|0.438
74071098|NCT04543136|147693697|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.689|TWO_SIDED|95.0|-0.55|0.83||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.83|-0.55|0.689
74071099|NCT04543136|147693698|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.309|TWO_SIDED|95.0|-0.92|0.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.30|-0.92|0.309
74071100|NCT04543136|147693698|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.109|TWO_SIDED|95.0|-1.1|0.11||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.11|-1.10|0.109
73883651|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.547||||0.0064||95.0|0.718|4.377|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.377|0.718|0.0064
73883652|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.562||||0.0073||95.0|0.691|4.433|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.433|0.691|0.0073
74071101|NCT04543136|147693698|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.555|TWO_SIDED|95.0|-0.43|0.79||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.79|-0.43|0.555
73883653|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.589||||0.0091||95.0|0.643|4.535|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.535|0.643|0.0091
73883654|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.604||||0.0103||95.0|0.616|4.592|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.592|0.616|0.0103
74071102|NCT04543136|147693699|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.896|TWO_SIDED|95.0|-0.35|0.31||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.31|-0.35|0.896
74071103|NCT04543136|147693699|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.32|TWO_SIDED|95.0|-0.49|0.16||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.16|-0.49|0.320
74071104|NCT04543136|147693699|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.39|TWO_SIDED|95.0|-0.19|0.47||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.47|-0.19|0.390
74071105|NCT04543136|147693700|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.802|TWO_SIDED|95.0|-0.51|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-0.51|0.802
74071106|NCT04543136|147693700|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.082|TWO_SIDED|95.0|-0.85|0.05||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.05|-0.85|0.082
74071107|NCT04543136|147693700|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.137|TWO_SIDED|95.0|-0.11|0.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.80|-0.11|0.137
74071108|NCT04543136|147693701|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.525|TWO_SIDED|95.0|-0.89|0.46||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.46|-0.89|0.525
74071109|NCT04543136|147693701|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.098|TWO_SIDED|95.0|-1.24|0.11||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.11|-1.24|0.098
74071110|NCT04543136|147693701|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.306|TWO_SIDED|95.0|-0.33|1.02||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.02|-0.33|0.306
74071111|NCT01626079|147693704|NON_INFERIORITY|Two thousand (2000) simulations were performed to calculate sample size and power for the primary safety endpoint. Assuming 22% mortality and 7.5% attrition at 12 months, a total of 305 subjects in the Device group will provide \> 95% power to reject the null hypothesis at the one-sided significance level of 5%.|Kaplan Meier|0.966|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|ONE_SIDED|95.0|0.948||||Z test Using Kaplan Meier Survival|P-value calculated from Z test using Kaplan Meier survival estimate together with Greenwood method estimated variance|||||0.948|<0.0001
74071112|NCT01626079|147693737|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.02|TWO_SIDED|95.0|0.6|0.96|||Joint Fraility Model|||||0.96|0.60|<0.02
74071113|NCT01626079|147693738|SUPERIORITY||Win Ratio|1.61|||<|0.0001|TWO_SIDED|95.0|1.29|2.04|||Finkelstein-Schoenfeld Analysis|||||2.04|1.29|<0.0001
74071114|NCT00865709|147694068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.884||||0.2309|TWO_SIDED|95.0|0.635|1.231||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PFS events would provide a \> 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing the null hypothesis H0: HR ≥ 1 versus the alternative hypothesis H1: HR \< 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population, defined as all subjects who were randomized to treatment.||1.231|0.635|0.2309
74071115|NCT00865709|147694070|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.829||||0.1437|TWO_SIDED|95.0|0.586|1.174||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PDs would provide a \> 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing H0: HR ≥ 1 versus H1: HR \< 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).||1.174|0.586|0.1437
74071116|NCT00865709|147694071|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||1-sided p-value from the Cochran-Mantel-Haenszel test, adjusting for the stratification factors of # metastatic sites and liver metastasis determined by Principal Investigator|Cochran-Mantel-Haenszel|||The proportion of subjects achieving overall response (CR or PR), when confirmation of response was not required, was estimated with a 95% confidence interval for each treatment group. The treatment groups were compared with respect to overall response rate using the Cochran-Mantel-Haenszel test, adjusting for the stratification factors.||||0.023
74071117|NCT00429923|147694073|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Mantel Haenszel|||||||0.0014
74071118|NCT00662129|147694105|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
74071119|NCT01055223|147694106|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|1.13|1.78|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.78|1.13|
74071120|NCT01055223|147694106|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.93|1.52|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.52|0.93|
74071121|NCT01055223|147694106|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|0.78|2.98|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||2.98|0.78|
74071122|NCT01055223|147694106|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|0.74|2.89|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||2.89|0.74|
74071123|NCT01055223|147694106|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01|||||TWO_SIDED|95.0|0.18|22.14|||||Undadjusted Odds Ratio. Reference Group: TZD alone.|||22.14|0.18|
74071124|NCT01055223|147694106|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.12|15.5|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||15.50|0.12|
74071125|NCT01055223|147694107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41|||||TWO_SIDED|95.0|1.05|1.89|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.89|1.05|
74071126|NCT01055223|147694107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.88|1.65|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.65|0.88|
74071127|NCT01055223|147694107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.69|3.6|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||3.60|0.69|
74071128|NCT01055223|147694107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63|||||TWO_SIDED|95.0|0.7|3.81|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||3.81|0.70|
74071129|NCT01055223|147694107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
74071130|NCT01055223|147694107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
74071131|NCT01055223|147694108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.92|1.79|||||Unadjusted Odds Ratio. Reference Group: TZD alone.|||1.79|0.92|
74071132|NCT01055223|147694108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.71|1.45|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.45|0.71|
74071133|NCT01055223|147694108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||||TWO_SIDED|95.0|0.1|1.9|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.90|0.10|
74071134|NCT01055223|147694108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||||TWO_SIDED|95.0|0.08|1.54|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.54|0.08|
74071135|NCT01055223|147694108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99|||||TWO_SIDED|95.0|0.18|21.93|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||21.93|0.18|
74071136|NCT01055223|147694108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.09|12.36|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||12.36|0.09|
74071137|NCT01055223|147694109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.8|1.88|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.88|0.80|
74071138|NCT01055223|147694109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.62|1.57|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.57|0.62|
74071139|NCT01055223|147694109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
74071140|NCT01055223|147694109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
74071141|NCT01055223|147694109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
74071142|NCT01055223|147694109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates|||0.00|0.00|
74071143|NCT01055223|147694110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.46|||||TWO_SIDED|95.0|1.53|19.45|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||19.45|1.53|
74071144|NCT01055223|147694110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|||||TWO_SIDED|95.0|0.64|15.86|||||Unadjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||15.86|0.64|
74071145|NCT01055223|147694110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
74071146|NCT01055223|147694110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
74071147|NCT01055223|147694110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
74071148|NCT01055223|147694110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
74071149|NCT01055223|147694111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.26|||||TWO_SIDED|95.0|0.66|80.35|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||80.35|0.66|
74071150|NCT01055223|147694111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78|||||TWO_SIDED|95.0|0.03|96.47|||||Adjusted Odds Ratio. Reference group: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosponates.|||96.47|0.03|
73883655|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.631||||0.0125||95.0|0.567|4.695|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.695|0.567|0.0125
73883656|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.645||||0.0138||95.0|0.539|4.752|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.752|0.539|0.0138
73883657|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.672||||0.0164||95.0|0.49|4.855|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.855|0.490|0.0164
73883658|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.687||||0.0179||95.0|0.462|4.912|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.912|0.462|0.0179
74071151|NCT01055223|147694111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference Group: TZD alone.|||0.00|0.00|
74071152|NCT01055223|147694111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
74071153|NCT01055223|147694111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
74071154|NCT01055223|147694111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
74071155|NCT02799602|147694112|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.675|||<|0.0001|TWO_SIDED|95.0|0.568|0.801||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.801|0.568|<0.0001
74071156|NCT02799602|147694115|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.357|||<|0.0001|TWO_SIDED|95.0|0.302|0.421||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.421|0.302|<0.0001
74071157|NCT02799602|147694117|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.792||||0.0058|TWO_SIDED|95.0|0.66|0.95||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.950|0.660|0.0058
74071158|NCT02799602|147694119|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.609|||<|0.0001|TWO_SIDED|95.0|0.516|0.718||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.718|0.516|<0.0001
74071159|NCT02799602|147694121|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.712||||0.0081|TWO_SIDED|95.0|0.539|0.94||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.940|0.539|0.0081
74071160|NCT02799602|147694123|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio, log|0.388|||<|0.0001|TWO_SIDED|95.0|0.328|0.458||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.458|0.328|<0.0001
73883659|NCT00083889|147300799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.714||||0.0208||95.0|0.413|5.015|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||5.015|0.413|0.0208
73883660|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049||||0.0004|TWO_SIDED|95.0|0.022|0.076|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EuroQoL Five Dimension (EQ-5D): Health state index baseline score (intercept and time since randomization are included as random effects).||0.076|0.022|0.0004
73883661|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.075|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.075|0.022|0.0003
73883662|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.074|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.074|0.022|0.0003
74071161|NCT02799602|147694125|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|1.043||||0.7073|TWO_SIDED|95.0|0.894|1.217||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|1.217|0.894|0.7073
74071162|NCT02799602|147694127|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.688||||0.0037|TWO_SIDED|95.0|0.523|0.906||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.906|0.523|0.0037
74071163|NCT02275364|147694142|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|15.28|||<|0.0001|TWO_SIDED|95.0|12.32|18.25||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||18.25|12.32|<0.0001
74071164|NCT02275364|147694143|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.93||||0.7366|TWO_SIDED|95.0|-6.43|4.57||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||4.57|-6.43|0.7366
74071165|NCT02275364|147694144|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1533.74||||0.0004|TWO_SIDED|95.0|794.16|2273.32||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||2273.32|794.16|0.0004
74071166|NCT02275364|147694145|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.46||||0.7278|TWO_SIDED|95.0|-3.06|2.14||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||2.14|-3.06|0.7278
74071167|NCT02275364|147694146|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|191.72||||0.1639|TWO_SIDED|95.0|-78.62|462.06||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||462.06|-78.62|0.1639
74071168|NCT02275364|147694147|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02||||0.4621|TWO_SIDED|95.0|-0.03|0.07||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||0.07|-0.03|0.4621
74071169|NCT02579096|147694151|NON_INFERIORITY|A non-inferiority bound of 8% was established during the trial design; a one-sided alpha level was set at 0.05.|Risk Difference (RD)|-7.0|||<|0.001|ONE_SIDED|95.0||-1.2|||t-test, 1 sided|||One-sided null hypothesis posited that allopurinol was inferior to febuxostat. The proportions of participants with ≥ 1 gout flare during phase 3 were compared between the two treatments.||-1.2||<0.001
74071170|NCT02097121|147694192|SUPERIORITY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.107|=|0.3802|TWO_SIDED|95.0|-3.203|1.243|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used."||1.243|-3.203|= 0.3802
73883663|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047||||0.0003||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.021|0.0003
73883664|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046||||0.0004||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.021|0.0004
73883665|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045||||0.0005||95.0|0.02|0.071|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.020|0.0005
73883666|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045||||0.0007||95.0|0.019|0.07|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.019|0.0007
73883667|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044||||0.0011||95.0|0.017|0.07|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.017|0.0011
73883668|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043||||0.0016||95.0|0.016|0.07|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.016|0.0016
73883669|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.0029||95.0|0.014|0.07|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.014|0.0029
73883670|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.0041||95.0|0.013|0.07|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.013|0.0041
73883671|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041||||0.0076||95.0|0.011|0.071|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.011|0.0076
73883672|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.0105||95.0|0.009|0.071|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.009|0.0105
74071171|NCT02097121|147694192|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.154|=|0.733|TWO_SIDED|95.0|-1.921|2.712|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used."||2.712|-1.921|= 0.733
74071172|NCT02097121|147694193|SUPERIORITY||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|1.442|=|0.5743|TWO_SIDED|95.0|-2.082|3.713|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||3.713|-2.082|= 0.5743
74071173|NCT02097121|147694193|SUPERIORITY||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|1.455|=|0.1451|TWO_SIDED|95.0|-0.769|5.078|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||5.078|-0.769|= 0.1451
74071174|NCT02097121|147694194|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.434|=|0.8206|TWO_SIDED|95.0|-3.205|2.551|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||2.551|-3.205|= 0.8206
74071175|NCT02097121|147694194|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|1.434|=|0.9604|TWO_SIDED|95.0|-2.807|2.95|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||2.95|-2.807|= 0.9604
74071176|NCT02097121|147694196|SUPERIORITY||LS Mean Difference|35.33|STANDARD_ERROR_OF_MEAN|22.175|=|0.1174|TWO_SIDED|95.0|-9.207|79.873|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||79.873|-9.207|= 0.1174
74071177|NCT02097121|147694196|SUPERIORITY||LS Mean Difference|34.11|STANDARD_ERROR_OF_MEAN|23.722|=|0.1567|TWO_SIDED|95.0|-13.536|81.76|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||81.76|-13.536|= 0.1567
74071178|NCT02097121|147694197|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|4.091|=|0.7481|TWO_SIDED|95.0|-9.553|6.909|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||6.909|-9.553|= 0.7481
74071179|NCT02097121|147694197|SUPERIORITY||LS Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|4.299|=|0.6691|TWO_SIDED|95.0|-6.799|10.498|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||10.498|-6.799|= 0.6691
74071180|NCT02097121|147694198|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.343|=|0.9297|TWO_SIDED|95.0|-0.721|0.661|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.661|-0.721|= 0.9297
74071181|NCT02097121|147694198|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.357|=|0.3976|TWO_SIDED|95.0|-1.022|0.413|||ANCOVA|||Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.||0.413|-1.022|= 0.3976
74071182|NCT02097121|147694199|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.302|=|0.3309|TWO_SIDED|95.0|-0.311|0.904|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.904|-0.311|= 0.3309
74071183|NCT02097121|147694199|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.315|=|0.2235|TWO_SIDED|95.0|-0.245|1.024|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||1.024|-0.245|= 0.2235
74071184|NCT02097121|147694200|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.274|=|0.6689|TWO_SIDED|95.0|-0.434|0.67|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.67|-0.434|= 0.6689
74071185|NCT02097121|147694200|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.288|=|0.6076|TWO_SIDED|95.0|-0.431|0.729|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.729|-0.431|= 0.6076
74071186|NCT02097121|147694201|SUPERIORITY||Risk difference %|15.5|||=|0.6092|TWO_SIDED|95.0|-18.94|46.19|||Cochran-Mantel-Haenszel|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period)."||46.19|-18.94|= 0.6092
73883673|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.0179||95.0|0.007|0.072|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.007|0.0179
73883674|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.0236||95.0|0.005|0.072|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.005|0.0236
73883675|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.037||95.0|0.002|0.073|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.073|0.002|0.0370
73883676|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.0464||95.0|0.001|0.074|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.074|0.001|0.0464
74071187|NCT02097121|147694201|SUPERIORITY||Risk difference %|17.6|||=|0.4824|TWO_SIDED|95.0|-16.2|48.9|||Cochran-Mantel-Haenszel|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period)."||48.9|-16.2|= 0.4824
73883677|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.0667||95.0|-0.002|0.075|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.075|-0.002|0.0667
74071188|NCT00661999|147694212|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.||||0.39
74071189|NCT00661999|147694212|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.||||0.73
74071190|NCT00661999|147694214|SUPERIORITY_OR_OTHER|||||||0.725||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.||||0.7250
74071191|NCT00661999|147694214|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.||||0.8700
74071192|NCT00661999|147694215|SUPERIORITY_OR_OTHER|||||||0.6639||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.6639
73883678|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.08||95.0|-0.004|0.076|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.076|-0.004|0.0800
74071193|NCT00661999|147694215|SUPERIORITY_OR_OTHER|||||||0.566||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.5660
74071194|NCT00661999|147694216|SUPERIORITY_OR_OTHER|||||||0.1124||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.1124
74071195|NCT00661999|147694216|SUPERIORITY_OR_OTHER|||||||0.2051||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.2051
74071196|NCT00661999|147694217|SUPERIORITY_OR_OTHER|||||||0.0648||95.0|||||Log Rank|||||||0.0648
74071197|NCT00661999|147694219|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.61
74071198|NCT00661999|147694219|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.44
74071199|NCT00661999|147694220|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.62
74071200|NCT00661999|147694220|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.30
74071201|NCT00661999|147694221|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.19
74071202|NCT00661999|147694221|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.17
74071203|NCT00661999|147694222|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.73
74071204|NCT00661999|147694222|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.83
74071205|NCT00661999|147694223|SUPERIORITY_OR_OTHER|||||||0.3852||95.0||||Test Comparison for Week 1 Level|Kruskal-Wallis|||||||0.3852
74071206|NCT00661999|147694223|SUPERIORITY_OR_OTHER|||||||0.0663||95.0||||Test Comparison for Week 7 Level.|Kruskal-Wallis|||||||0.0663
74071207|NCT00661999|147694223|SUPERIORITY_OR_OTHER|||||||0.322||95.0||||Test Comparison for Week 16 Level|Kruskal-Wallis|||||||0.3220
74071208|NCT00661999|147694224|SUPERIORITY_OR_OTHER|||||||0.1826||95.0||||Test Comparison for Week 1 Level.|Kruskal-Wallis|||||||0.1826
74071209|NCT00661999|147694224|SUPERIORITY_OR_OTHER|||||||0.0113||95.0||||Test comparison for week 7 level|Kruskal-Wallis|||||||0.0113
74071210|NCT00661999|147694224|SUPERIORITY_OR_OTHER|||||||0.3358||95.0||||Test Comparison for week 16 level|Kruskal-Wallis|||||||0.3358
74071211|NCT00661999|147694225|SUPERIORITY_OR_OTHER|||||||0.9022||95.0||||Test comparison for Baseline level.|Kruskal-Wallis|||||||0.9022
74071212|NCT00661999|147694225|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||Test Comparison for Week 7 Level.|Kruskal-Wallis|||||||0.0002
74071213|NCT00661999|147694225|SUPERIORITY_OR_OTHER|||||||0.0022||95.0||||Test Comparison for Week 16 Level.|Kruskal-Wallis|||||||0.0022
74071214|NCT00661999|147694226|SUPERIORITY_OR_OTHER|||||||0.1137||95.0||||Test comparison for baseline level.|Kruskal-Wallis|||||||0.1137
74071215|NCT00661999|147694226|SUPERIORITY_OR_OTHER|||||||0.8042||95.0||||Test comparison for week 7 level.|Kruskal-Wallis|||||||0.8042
74071216|NCT00661999|147694226|SUPERIORITY_OR_OTHER|||||||0.2016||95.0||||Test comparison for week 16 level.|Kruskal-Wallis|||||||0.2016
74071217|NCT00661999|147694227|SUPERIORITY_OR_OTHER|||||||0.1139||95.0||||Test comparison for baseline level.|Kruskal-Wallis|||||||0.1139
74071218|NCT00661999|147694227|SUPERIORITY_OR_OTHER|||||||0.0424||95.0||||Test comparison for week 7 level.|Kruskal-Wallis|||||||0.0424
74071219|NCT00661999|147694227|SUPERIORITY_OR_OTHER|||||||0.2025||95.0||||Test comparison for week 16 level.|Kruskal-Wallis|||||||0.2025
73883679|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035||||0.107||95.0|-0.007|0.077|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.077|-0.007|0.1070
73883680|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.1237||95.0|-0.009|0.078|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.078|-0.009|0.1237
74071220|NCT00663871|147694257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.04||||0.59|TWO_SIDED|95.0|-0.27|0.19|||ANOVA|||||0.19|-0.27|0.59
73883681|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.1561||95.0|-0.013|0.079|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.079|-0.013|0.1561
73883682|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.1752||95.0|-0.015|0.08|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.080|-0.015|0.1752
73883683|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.2112||95.0|-0.018|0.081|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.081|-0.018|0.2112
73883684|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.2319||95.0|-0.02|0.082|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.082|-0.020|0.2319
73883685|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.2698||95.0|-0.023|0.084|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.084|-0.023|0.2698
73883686|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.291||95.0|-0.025|0.085|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.085|-0.025|0.2910
73883687|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.3293||95.0|-0.029|0.086|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.086|-0.029|0.3293
73883688|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.3504||95.0|-0.031|0.087|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.087|-0.031|0.3504
73883689|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.3881||95.0|-0.034|0.089|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.089|-0.034|0.3881
73883690|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.4086||95.0|-0.036|0.09|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.090|-0.036|0.4086
73883691|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.4449||95.0|-0.04|0.091|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.091|-0.040|0.4449
73883692|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.4646||95.0|-0.042|0.092|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.092|-0.042|0.4646
73883693|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.499||95.0|-0.046|0.094|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.094|-0.046|0.4990
73883694|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.5176||95.0|-0.048|0.095|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.095|-0.048|0.5176
73883695|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023||||0.5501||95.0|-0.051|0.097|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.097|-0.051|0.5501
74071221|NCT00663871|147694258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.05||||0.21|TWO_SIDED|95.0|-0.24|0.19|||ANOVA|||||0.19|-0.24|0.21
74071222|NCT00663871|147694259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.92|TWO_SIDED|95.0|0.69|1.5||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time. The Negative Affect scores were categorized by quartiles of the baseline measures.|Mixed Models Analysis|Generalized Linear Mixed Modeling was used with a multinomial distribution with cumulative link.||||1.50|0.69|0.92
74071223|NCT00663871|147694260|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.86|TWO_SIDED|95.0|-1.21|1.44||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||1.44|-1.21|0.86
74071224|NCT00663871|147694261|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.31||||0.63|TWO_SIDED|95.0|-1.57|0.94||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.94|-1.57|0.63
74071225|NCT00663871|147694262|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.32||||0.5|TWO_SIDED|95.0|-1.25|0.61||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.61|-1.25|0.50
74071226|NCT00663871|147694263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.33||||0.25|TWO_SIDED|95.0|-0.23|0.88||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.88|-0.23|0.25
74071227|NCT00663871|147694264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.52|TWO_SIDED|95.0|-1.83|0.92||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.92|-1.83|0.52
74071228|NCT00663871|147694265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.52|TWO_SIDED|95.0|0.67|2.24||The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time. The Type A personality scores were categorized by quartiles of the baseline measures.|Mixed Models Analysis|Generalized Linear Mixed Modeling was used with a multinomial distribution with cumulative link.||||2.24|0.67|0.52
74071229|NCT00663871|147694266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.03||||0.68|TWO_SIDED|95.0|-0.16|0.1||The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.10|-0.16|0.68
74071230|NCT00663871|147694267|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.17||||0.16|TWO_SIDED|95.0|-0.41|0.07|||Mixed Models Analysis|||||0.07|-0.41|0.16
74071231|NCT00663871|147694268|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.05||||0.59|TWO_SIDED|95.0|-0.24|0.14|||Mixed Models Analysis|||||0.14|-0.24|0.59
74071232|NCT00663871|147694269|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|0.06||||0.35|TWO_SIDED|95.0|-0.06|0.18|||Mixed Models Analysis|||||0.18|-0.06|0.35
74071233|NCT00663871|147694270|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|0.04||||0.74|TWO_SIDED|95.0|-0.18|0.25|||Mixed Models Analysis|||||0.25|-0.18|0.74
74071234|NCT00663871|147694271|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.1||||0.28|TWO_SIDED|95.0|-0.27|0.08|||Mixed Models Analysis|||||0.08|-0.27|0.28
74071235|NCT00663871|147694272|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.15||||0.76|TWO_SIDED|95.0|-0.09|0.39|||Repeated Measures MANOVA|||||0.39|-0.09|0.76
74071236|NCT00663871|147694273|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.06||||0.62|TWO_SIDED|95.0|-0.18|0.3|||Repeated Measures MANOVA|||||0.30|-0.18|0.62
74071237|NCT00663871|147694274|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.03||||0.42|TWO_SIDED|95.0|-0.21|0.26|||Repeated Measures MANOVA|||||0.26|-0.21|0.42
74071238|NCT00663871|147694275|SUPERIORITY_OR_OTHER_LEGACY||Standardized mean difference|-0.06||||0.54|TWO_SIDED|95.0|-0.3|0.18|||Repeated Measures MANOVA|Repeated Measures MANOVA||||0.18|-0.30|0.54
74071239|NCT03384745|147694290|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 25 (48.1% \[34.0-62.4\], p\<0.0001) of 52 participants in the M1095 30mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
74071240|NCT03384745|147694290|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 44 (84.6% \[71.9-93.1\], p\<0.0001) of 52 participants in the M1095 60mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
73883696|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022||||0.5675||95.0|-0.054|0.098|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.098|-0.054|0.5675
73883697|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021||||0.5979||95.0|-0.057|0.099|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.099|-0.057|0.5979
73883698|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021||||0.6141||95.0|-0.059|0.1|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.100|-0.059|0.6141
74071241|NCT03384745|147694290|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% \[63.8-87.7\], p\<0.0001) of 53 participants in the M1095 120mg normal load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
74071242|NCT03384745|147694290|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 45 (88.2% \[76.1-95.6\], p\<0.0001) of 51 participants in the M1095 120mg augmented load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
74071243|NCT03384745|147694290|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% \[63.8-87.7\], p\<0.0001) of 53 participants in the secukinumab 300mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
74071244|NCT02739984|147694316|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-64.14|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-68.16|-60.12|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-60.12|-68.16|<0.0001
74071245|NCT02739984|147694317|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-53.14|STANDARD_ERROR_OF_MEAN|2.25|<|0.0001|TWO_SIDED|95.0|-57.56|-48.71|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-48.71|-57.56|<0.0001
74071246|NCT02739984|147694318|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-67.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-72.1|-62.2|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-62.2|-72.1|<0.0001
74071247|NCT02739984|147694319|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-55.8|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-61.0|-50.5|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-50.5|-61.0|<0.0001
74071248|NCT02739984|147694320|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-56.56|STANDARD_ERROR_OF_MEAN|1.89|<|0.0001|TWO_SIDED|95.0|-60.28|-52.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-52.85|-60.28|<0.0001
74071249|NCT02739984|147694321|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-46.28|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-50.42|-42.15|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-42.15|-50.42|<0.0001
74071250|NCT02739984|147694322|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-52.48|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-56.1|-48.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-48.85|-56.10|<0.0001
74071251|NCT02739984|147694323|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-42.12|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-46.13|-38.11|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-38.11|-46.13|<0.0001
74071252|NCT02739984|147694324|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-41.06|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|95.0|-43.9|-38.22|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-38.22|-43.90|<0.0001
74071253|NCT02739984|147694325|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-33.74|STANDARD_ERROR_OF_MEAN|1.59|<|0.0001|TWO_SIDED|95.0|-36.87|-30.6|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-30.60|-36.87|<0.0001
74071254|NCT02739984|147694326|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|77.9|||<|0.0001|TWO_SIDED|95.0|70.0|83.5|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||83.5|70.0|<0.0001
74071255|NCT02739984|147694327|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|69.1|||<|0.0001|TWO_SIDED|95.0|60.4|75.7|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||75.7|60.4|<0.0001
73883699|NCT00083889|147300800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.6424||95.0|-0.063|0.102|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.102|-0.063|0.6424
73883700|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.026|||<|0.0001|TWO_SIDED|95.0|2.088|5.965|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Euro-QoL Visual Analog Scale (EQ-VAS) baseline score (intercept and time since randomization are included as random effects).||5.965|2.088|<.0001
74071256|NCT02739984|147694328|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|83.5|||<|0.0001|TWO_SIDED|95.0|77.7|87.4|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||87.4|77.7|<0.0001
74071257|NCT02739984|147694329|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|64.7|||<|0.0001|TWO_SIDED|95.0|57.7|70.3|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||70.3|57.7|<0.0001
74071258|NCT02739984|147694330|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-40.5|STANDARD_ERROR_OF_MEAN|3.87|<|0.0001|TWO_SIDED|95.0|-48.11|-32.9|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-32.90|-48.11|<0.0001
74071259|NCT02739984|147694331|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-32.56|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-39.58|-25.53|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-25.53|-39.58|<0.0001
74071260|NCT02739984|147694332|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-19.25|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-25.95|-12.54|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-12.54|-25.95|<0.0001
74071261|NCT02739984|147694333|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.7|STANDARD_ERROR_OF_MEAN|4.02|<|0.0001|TWO_SIDED|95.0|-21.6|-5.8|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-5.80|-21.60|<0.0001
74071262|NCT02739984|147694334|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|9.8|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|6.95|12.64|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||12.64|6.95|<0.0001
74071263|NCT02739984|147694335|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|7.37|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|4.19|10.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||10.56|4.19|<0.0001
74071264|NCT02739984|147694336|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-17.06|STANDARD_ERROR_OF_MEAN|2.98|<|0.0001|TWO_SIDED|95.0|-22.91|-11.21|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-11.21|-22.91|<0.0001
74071265|NCT02739984|147694337|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.33|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|95.0|-20.09|-6.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-6.56|-20.09|<0.0001
74071266|NCT00955747|147694339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.4|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||All tests will be two-tailed. Unless specified otherwise, p-values less than or equal to O.050, when rounded to four decimal places,will be considered statistically significant.||||<0.05
74071267|NCT00539539|147694340|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.001||||0.96|TWO_SIDED|95.0|-0.04|0.05|||t-test, 2 sided|||Average change in cluster-specific rates of ROSC.||0.05|-0.04|0.96
74071268|NCT00539539|147694341|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.8||||0.71|TWO_SIDED|95.0|-4.9|3.4|||t-test, 2 sided|||Average difference in cluster-specific rates.||3.4|-4.9|0.71
73883701|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.165|||<|0.0001||95.0|2.269|6.061|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.061|2.269|<.0001
73883702|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.243|||<|0.0001||95.0|2.358|6.128|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.128|2.358|<.0001
74071269|NCT00539539|147694342|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.015||||0.21|TWO_SIDED|95.0|-0.039|0.009|||t-test, 2 sided|By-cluster difference in outcome rates.||Average change in cluster-specific risk difference.||0.009|-0.039|0.21
73883703|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.382|||<|0.0001||95.0|2.494|6.269|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.269|2.494|<.0001
73883704|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.459|||<|0.0001||95.0|2.558|6.361|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.361|2.558|<.0001
74071270|NCT00539539|147694343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.016|TWO_SIDED|95.0|0.4|3.4|||Regression, Linear|Difference in means, adjusted for cluster.||Cluster adjusted difference in average CPR fraction.||3.4|0.4|0.016
74071271|NCT00539539|147694344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.005|TWO_SIDED|95.0|0.5|2.7|||Regression, Linear|Adjusted for randomization by cluster.||Cluster adjusted difference in means.||2.7|0.5|0.005
74071272|NCT00539539|147694345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|||<|0.001|TWO_SIDED|95.0|-6.4|-3.0|||Regression, Linear|||Cluster adjusted difference in average compression rate.||-3.0|-6.4|<0.001
74071273|NCT00539539|147694346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4|||<|0.001|TWO_SIDED|95.0|-5.2|-1.5|||Regression, Linear|||Cluster adjusted difference in the average rate.||-1.5|-5.2|<0.001
74071274|NCT00539539|147694347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.73|TWO_SIDED|95.0|-0.5|0.7|||Regression, Linear|||Cluster adjusted difference in average rate.||0.7|-0.5|0.73
74071275|NCT00767325|147694350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|-1.2|-0.1|||||Day 7|||-0.1|-1.2|
73883705|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.598|||<|0.0001||95.0|2.65|6.547|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.547|2.650|<.0001
74071276|NCT00767325|147694350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|-2.0|-0.7|||||Day 15|||-0.7|-2.0|
74071277|NCT00767325|147694350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.383|||TWO_SIDED|95.0|-3.2|-1.7|||||Day 29|||-1.7|-3.2|
74071278|NCT00767325|147694350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.384|||TWO_SIDED|95.0|-3.7|-2.1|||||Day 43|||-2.1|-3.7|
74071279|NCT00767325|147694350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|95.0|-4.0|-2.4|||||Day 57|||-2.4|-4.0|
74071280|NCT00767325|147694350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|95.0|-4.7|-2.9|||||Day 85|||-2.9|-4.7|
74071281|NCT00767325|147694350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|0.472|||TWO_SIDED|95.0|-5.4|-3.5|||||Day 113|||-3.5|-5.4|
74071282|NCT00767325|147694350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.492|||TWO_SIDED|95.0|-5.8|-3.8|||||Day 141|||-3.8|-5.8|
74071283|NCT00767325|147694350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|95.0|-5.8|-3.9|||||Day 169|||-3.9|-5.8|
74071284|NCT02260492|147694376|EQUIVALENCE|"Equivalence test compares the Test/Reference with confidence bounds set at standard 80-125%.~Superiority test compares Test with Placebo (p\<0.05) Superiority test compares Reference with Placebo (p\<0.05) (p\<0.05)"|Test/Reference|1.0799|||<|0.05|TWO_SIDED|90.0|0.8|1.25|||ANCOVA|||"Primary analyses were conducted on BL subtracted values (pre-dose - post-dose). The two one-sided tests method of interval analysis is standard for bioequivalence testing and employs 2 sets of one-sided hypotheses as follows, performed at the 5% alpha level:~H01: uT-uR \< -0.20 uR vs. Ha1: -0.20 uR \</= uT- uR (the lower tail) and H02: uT-uR \>0.25 uR vs. Ha2: uT- uR \</=0.25 uR (the upper tail) When uT is the LSM SOLIS, uR is the LSM of ADVAIR DISKUS"|"Day 1 superiority to placebo:~Solis vs. Placebo p=0.004 Advair vs. Placebo p=0.012"|1.25|.8|<0.05
73883706|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.676|||<|0.0001||95.0|2.689|6.662|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.662|2.689|<.0001
73883707|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.815|||<|0.0001||95.0|2.741|6.889|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.889|2.741|<.0001
74071285|NCT02260492|147694377|EQUIVALENCE|Standard bioequivalence 90% confidence bounds set at 0.8-1.25.|Test/Reference|1.0475|||<|0.05|TWO_SIDED|90.0|0.8|1.25|||ANOVA|||Same as the Day 1 analyses|"Week 4 superiority to placebo:~Solis vs. Placebo p=0.019 Advair vs. Placebo p=0.035"|1.25|.8|<0.05
74071286|NCT00996736|147694380|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin is less than 1.5 lines logMAR acuity. (Adjusted three-month visual acuity confidence bounds for the difference between the voriconazole and natamycin groups which meet or exceed 0.15 logMAR units would not permit noninferiority to be declared.) Note that this design also allows declaration of superiority (2-sided alpha of 0.05, corrected for an interim analysis).|Mean Difference (Net)|-0.18||||0.006|TWO_SIDED|95.0|-0.3|-0.05|||Regression, Linear|||||-0.05|-0.30|0.006
74071287|NCT00365352|147694391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0015||95.0|-5.6|-1.3|||ANCOVA||Mean difference was adjusted for Baseline value, treatment pooled sites, and treatment by pool site interaction.|||-1.3|-5.6|0.0015
74071288|NCT00365352|147694392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.287||||0.0001||95.0|2.338|7.861|||Regression, Logistic|A logistic regression model was used with treatment and pooled center as explanatory factors.||||7.861|2.338|0.0001
74071289|NCT00097695|147694418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.142||95.0|||||Wilcoxon version of the log-rank test|The Wilcoxon version of the log-rank test of SAS was used to calculate statistical significance between p- vs icatibant group and placebo group.||||||0.142
74071290|NCT00097695|147694419|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon version of the log-rank test|The median time to onset is calculated using Kaplan-Meier methodology. The Wilcoxon version of the log-rank test of SAS is used.||||||< 0.001
74071291|NCT00097695|147694420|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.079||95.0|||||Wilcoxon version of the log-rank test|The median time to almost complete symptom relief was calculated using Kaplan-Meier methodology.The Wilcoxon version of the log-rank test of SAS used.||||||= 0.079
74071292|NCT02016300|147694441|OTHER|||||||0.162|||||||Regression, Linear|||Difference between baseline and month 6.||||0.162
74071293|NCT02016300|147694441|OTHER|||||||0.094|||||||Regression, Linear|||Difference between baseline and month 12.||||0.094
74071294|NCT02016300|147694441|OTHER|||||||0.043|||||||Regression, Linear|||Difference between baseline and month 24.||||0.043
74071295|NCT02016300|147694442|OTHER|||||||0.387|||||||Regression, Linear|||Difference between baseline and month 6.||||0.387
74071296|NCT02016300|147694442|OTHER|||||||0.34|||||||Regression, Linear|||Difference between baseline and month 12.||||0.340
74071297|NCT02016300|147694442|OTHER|||||||0.179|||||||Regression, Linear|||Difference between baseline and month 24.||||0.179
74071298|NCT02016300|147694443|OTHER|||||||0.729|||||||Regression, Linear|||Difference between baseline and month 6.||||0.729
74071299|NCT02016300|147694443|OTHER|||||||0.958|||||||Regression, Linear|||Difference between baseline and month 12.||||0.958
74071300|NCT02016300|147694443|OTHER|||||||0.634|||||||Regression, Linear|||Difference between baseline and month 24.||||0.634
74071301|NCT02016300|147694444|OTHER|||||||0.733|||||||Regression, Linear|||Difference between baseline and month 6.||||0.733
74071302|NCT02016300|147694444|OTHER|||||||0.666|||||||Regression, Linear|||Difference between baseline and month 12.||||0.666
74071303|NCT02016300|147694444|OTHER|||||||0.854|||||||Regression, Linear|||Difference between baseline and month 24.||||0.854
74071304|NCT02016300|147694445|OTHER|||||||0.774|||||||Regression, Linear|||Difference between baseline and month 12.||||0.774
74071305|NCT02016300|147694445|OTHER|||||||0.414|||||||Regression, Linear|||Difference between baseline and month 24.||||0.414
74071306|NCT02016300|147694446|OTHER|||||||0.064|||||||Regression, Linear|||Difference between baseline and month 12.||||0.064
74071307|NCT02016300|147694446|OTHER|||||||0.276|||||||Regression, Linear|||Difference between baseline and month 24.||||0.276
74071308|NCT02016300|147694447|OTHER|||||||0.02|||||||Regression, Linear|||Difference between baseline and month 12.||||0.020
74071309|NCT02016300|147694447|OTHER|||||||0.091|||||||Regression, Linear|||Difference between baseline and month 24.||||0.091
74071310|NCT00797108|147694504|SUPERIORITY_OR_OTHER||Clinical Cure Difference|27.5|||||TWO_SIDED|80.0|-4.0|55.3||||||Two-sided 80% confidence interval (CI) for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.||55.3|-4.0|
74071311|NCT00797108|147694504|SUPERIORITY_OR_OTHER||Clinical Cure Difference|25.0|||||TWO_SIDED|80.0|-13.1|57.9||||||Two-sided 80% CI for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.||57.9|-13.1|
74071312|NCT02270736|147694527|SUPERIORITY||Least square mean (LS-mean) difference|-0.06|STANDARD_ERROR_OF_MEAN|0.019|=|0.0012|TWO_SIDED|95.0|-0.1|-0.03|||MMRM|||Least square mean (LS-Mean) is from a mixed model repeated measurement (MMRM) analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.03|-0.1|= 0.0012
74071313|NCT02270736|147694528|SUPERIORITY||Least square mean (LS-mean) difference|0.28|STANDARD_ERROR_OF_MEAN|0.127|=|0.032|TWO_SIDED|95.0|0.02|0.53|||MMRM|||LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline Modified Teacher Drooling Scale (mTDS) score as covariate.||0.53|0.02|= 0.032
73883708|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.892|||<|0.0001||95.0|2.76|7.024|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.024|2.760|<.0001
73883709|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.031|||<|0.0001||95.0|2.78|7.283|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.283|2.780|<.0001
73883710|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.109|||<|0.0001||95.0|2.783|7.435|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.435|2.783|<.0001
73883711|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.248|||<|0.0001||95.0|2.776|7.72|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.720|2.776|<.0001
74071314|NCT02270736|147694530|SUPERIORITY||Least square mean (LS-mean) difference|-0.09|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|-0.12|-0.05|||MMRM|||Statistical analysis at Week 8: LS-Mean is from a MMRM analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.05|-0.12|<0.0001
74071315|NCT02270736|147694530|SUPERIORITY||Least square mean (LS-mean) difference|-0.1|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|-0.14|-0.06|||MMRM|||Statistical analysis at Week 12: LS-Mean is from a MMRM analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.06|-0.14|<0.0001
74071316|NCT02270736|147694531|SUPERIORITY||Least square mean (LS-mean) difference|0.4|STANDARD_ERROR_OF_MEAN|0.116|=|0.0008|TWO_SIDED|95.0|0.17|0.63|||MMRM|||Statistical analysis at Week 8: LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline mTDS score as covariate.||0.63|0.17|=0.0008
73883712|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.325|||<|0.0001||95.0|2.767|7.884|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.884|2.767|<.0001
73883713|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.464|||<|0.0001||95.0|2.741|8.188|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.188|2.741|<.0001
73883714|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.542||||0.0001||95.0|2.723|8.361|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.361|2.723|0.0001
73883715|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.681||||0.0002||95.0|2.683|8.679|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.679|2.683|0.0002
74071317|NCT02270736|147694531|SUPERIORITY||Least square mean (LS-mean) difference|0.4|STANDARD_ERROR_OF_MEAN|0.132|=|0.0026|TWO_SIDED|95.0|0.14|0.66|||MMRM|||Statistical analysis at Week 12: LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline mTDS score as covariate.||0.66|0.14|=0.0026
73883716|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.758||||0.0003||95.0|2.657|8.859|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.859|2.657|0.0003
73883717|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.898||||0.0004||95.0|2.607|9.188|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.188|2.607|0.0004
73883718|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.975||||0.0006||95.0|2.576|9.374|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.374|2.576|0.0006
73883719|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.114||||0.0009||95.0|2.517|9.711|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.711|2.517|0.0009
73883720|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.191||||0.0011||95.0|2.482|9.9|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.900|2.482|0.0011
73883721|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.331||||0.0015||95.0|2.417|10.244|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.244|2.417|0.0015
74071318|NCT04908748|147694547|SUPERIORITY||Least squares mean difference|-29.1|||<|0.0001|TWO_SIDED|95.0|-32.2|-26.0|||ANCOVA|||||-26.0|-32.2|< 0.0001
74071319|NCT02433665|147694563|NON_INFERIORITY|The primary end point for this study was a comparison between fixed-dose and customized-dose contrast material injection CT protocols for vascular and parenchymal enhancement by using a noninferiority approach. The limit of noninferiority was set at 0.1 before the initiation of the study on the basis of a similar study that examined contrast media dose optimization for CT angiography examinations.|Odds Ratio, log|0.75|STANDARD_DEVIATION|0.35|>|0.05|TWO_SIDED|0.38|||||Mixed Models Analysis|||||||>0.05
74071320|NCT00757601|147694565|NON_INFERIORITY_OR_EQUIVALENCE|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR\[fed/fasted\]) of MK1006 AUC (0-∞).~The GMR (fed/fasted) was calculated using the geometric mean AUC (0-∞) of the fed state divided by the geometric mean AUC (0-∞) fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.03||||||95.0|||||Mixed-Effect Model|||A linear mixed-effect model was used to estimate the geometric mean AUC (0-∞) for MK1006 at every dose level.||||
74071321|NCT00757601|147694566|NON_INFERIORITY_OR_EQUIVALENCE|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR\[fed/fasted\]) of MK1006 Cmax.~The GMR (fed/fasted) was calculated using the geometric mean Cmax of the fed state divided by the geometric mean Cmax fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.14||||||95.0|||||Mixed-effect Model|||A linear mixed-effect model was used to estimate the geometric mean Cmax for MK1006 at every dose level.||||
74071322|NCT03702621|147694571|OTHER|P values are from mixed model least squares (LS) means differences with Sidak adjustment for multiple comparisons.||||||0.54|||||||Mixed Models Analysis|Sidak adjustment||||||0.54
74071323|NCT03702621|147694572|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.59|||||||Mixed Models Analysis|||||||0.59
74071324|NCT03702621|147694573|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.98||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||0.98
74071325|NCT03702621|147694574|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.94||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||0.94
74071326|NCT03702621|147694575|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.86|||||||Mixed Models Analysis|Sidak adjustment||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||0.86
74071327|NCT03702621|147694576|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||1||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||1.0
74071328|NCT03702621|147694577|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.99|||||||Mixed Models Analysis|||||||0.99
74071329|NCT03702621|147694578|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.99|||||||Mixed Models Analysis|||||||0.99
74071330|NCT03702621|147694579|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.72|||||||Mixed Models Analysis|||||||0.72
74071331|NCT03702621|147694580|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.29|||||||Mixed Models Analysis|||||||0.29
74071332|NCT03702621|147694581|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.46|||||||Mixed Models Analysis|||||||0.46
74071333|NCT03702621|147694582|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.77|||||||Mixed Models Analysis|||||||0.77
74071334|NCT03194464|147694618|OTHER|||||||0.15||||||The a priori threshold for statistical significance was established at p \<.05 (non-adjusted).|ANOVA|||We performed repeated measures analysis of variance (RM-ANOVA) to determine if intracortical inhibition, as measured by SICI, in the ipsilesional hemisphere was altered by less affected hand exercise to task-failure and to determine the time course and recovery of this effect.||||0.15
74071335|NCT03194464|147694619|SUPERIORITY|||||||0.83||||||Statistical Significance established as p \<.05|ANOVA|Repeated-Measures ANOVA||We performed repeated measures analysis of variance (RM-ANOVA) to determine if intracortical inhibition, as measured by SICI, in the ipsilesional hemisphere was altered by repeated sessions of less affected hand exercise to task-failure. Pre-exercise SICI was compared between Session1 and Session8.||||.83
74071336|NCT03194464|147694620|OTHER|||||||0.204|||||||ANOVA|||RM-ANOVA||||0.204
74071337|NCT03194464|147694621|SUPERIORITY|||||||0.004||||||statistical significance was established a priori at p \<.05|ANOVA|repeated measures ANOVA comparing Session8 vs. Session1 performance||We performed repeated measures analysis of variance (RM-ANOVA) to determine if motor dexterity, as measured by the BBT, was improved by repeated sessions of non-paretic hand exercise to task-failure. BBT performance was compared between Session1 and Session8.||||.004
74071338|NCT02606500|147694626|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic|||||||0.9
74071339|NCT02606500|147694627|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.5|||||||Regression, Logistic|||||||0.5
74071340|NCT02606500|147694628|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.3|||||||Regression, Logistic|||||||0.3
74071341|NCT02606500|147694629|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic|||||||0.9
74071342|NCT02606500|147694630|NON_INFERIORITY|We presumed Elonva 150 mcg in obese and normal weighing women yields comparable biochemical pregnancy rates.||||||0.4|||||||Regression, Logistic|||||||0.4
74071343|NCT01439165|147694656|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference of seroprotection rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||Comparison of anti-tetanus seroprotection rate between the two groups||1.2|-0.4|
74071344|NCT01439165|147694656|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of seroprotection rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|0.42|||||TWO_SIDED|95.0|-0.3|2.1||||||Comparison of anti-diphtheria seroprotection rates between the two groups||2.1|-0.3|
74071345|NCT01439165|147694657|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|-7.12|||||TWO_SIDED|95.0|-12.0|-1.7||||||Comparison of the anti-tetanus booster response rates between the two groups||-1.7|-12.0|
74071346|NCT01439165|147694657|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|-0.95|||||TWO_SIDED|95.0|-5.4|4.0||||||Comparison of the anti-diphteria booster response rates between the two groups||4.0|-5.4|
74071347|NCT01439165|147694658|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC ratio (Adacel/Historical Control)|1.04|||||TWO_SIDED|95.0|0.92|1.18||||||Comparison of anti-pertussis toxoid GMCs between Adacel and historical control groups||1.18|0.92|
74071348|NCT01439165|147694658|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|5.22|||||TWO_SIDED|95.0|4.51|6.05||||||Comparison of the anti-FHA GMCs between Adacel and historical Control groups||6.05|4.51|
74071349|NCT01439165|147694658|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|2.94|||||TWO_SIDED|95.0|2.46|3.51||||||Comparison of the anti-Pertactin GMCs between Adacel and historical Control groups||3.51|2.46|
74071350|NCT01439165|147694658|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|2.18|||||TWO_SIDED|95.0|1.84|2.6||||||Comparison of the post-vaccination anti-Fimbriae (types 2 and 3) GMCs between Adacel and historical Control groups||2.60|1.84|
74071351|NCT01439165|147694659|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|16.12|||||TWO_SIDED|95.0|13.27|18.73||||||comparison of anti-pertussis toxoid booster response rates was performed between the Adacel and historical groups||18.73|13.27|
74071352|NCT01439165|147694659|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) Adacel-Expected Booster|-4.21|||||TWO_SIDED|95.0|-7.23|-1.34||||||Comparison of the anti-FHA booster response rates between the Adacel and historical groups||-1.34|-7.23|
74071353|NCT01439165|147694659|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|-18.61|||||TWO_SIDED|95.0|-21.7|-15.6||||||Comparison of the anti-Pertactin booster response rates between Adacel and historical groups||-15.6|-21.7|
74071354|NCT01439165|147694659|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|-19.07|||||TWO_SIDED|95.0|-22.3|-16.0||||||Comparison of the anti-Fimbriae (types 2 and 3) booster response rates between Adacel and historical groups||-16.0|-22.3|
74071355|NCT00810368|147694661|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||2-tailed paired Student's t-tests between Week 0 and Week 12 responses (above) were anticipated to show significant benefits with carnosine treatment but no change with placebo. There were no corrections for multiple comparisons in the reported data.|t-test, 2 sided|Paired t-test||Description of Power Calculation: The planned sample size completing each arm was based on individual incremental improvements in the primary outcomes of : A) CFS Severity Scores (Baraniuk et al., Annals Allergy Astma Immunol, 1998), B) Instantaneous Fatigue (Kim et al. Journal of Rehab Res Dev, 2010), and C) increased accuracy of 4/35 letters for 2 back working memory task (Owen, Human Brain Mapping, 2005).||||0.30
74071356|NCT00810368|147694661|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
74071357|NCT00810368|147694662|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||Using Fisher's Exact Test, we determined whether there was a significant difference in the number of participants complaining of IBS symptoms.|Fisher Exact|2 by 2 Fisher's Exact Test||||||0.018
74071358|NCT00810368|147694663|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED||||||t-test, 2 sided|||||||0.0018
74071359|NCT00810368|147694663|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
74071360|NCT00810368|147694665|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
74071361|NCT00810368|147694666|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
74071362|NCT00810368|147694667|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
74071363|NCT01024738|147694682|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74071364|NCT03365375|147694687|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
74071365|NCT03879239|147694699|SUPERIORITY|||||||0.0011||||||Responder Rate on Weekly CSBM1 in the ITT (Intention to Treat) analysis set. (For details, refer to the primary outcome description).|Chi-squared|||||||0.0011
74071366|NCT03879239|147694699|SUPERIORITY|||||||0.0085||||||Responder Rate on Weekly CSBM2 in the ITT (Intention to Treat) analysis set. (For details, refer to the primary outcome description).|Chi-squared|||||||0.0085
74071367|NCT01966042|147694705|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman test (n=13)|||||||< 0.001
74071368|NCT00266409|147694712|SUPERIORITY_OR_OTHER|||||||0.1143||95.0|||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.1143
74071369|NCT00266409|147694712|SUPERIORITY_OR_OTHER|||||||0.4544||95.0|||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.4544
74071370|NCT00266409|147694713|SUPERIORITY_OR_OTHER|||||||0.0173||95.0|||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate||||0.0173
74071371|NCT00266409|147694713|SUPERIORITY_OR_OTHER|||||||0.0516||95.0|||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate||||0.0516
74071372|NCT00266409|147694714|SUPERIORITY_OR_OTHER|||||||0.0361||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.0361
74071373|NCT00266409|147694714|SUPERIORITY_OR_OTHER|||||||0.0366||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.0366
74071374|NCT00266409|147694715|SUPERIORITY_OR_OTHER|||||||0.739||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.7390
74071375|NCT00266409|147694715|SUPERIORITY_OR_OTHER|||||||0.6735||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.6735
74071376|NCT00266409|147694716|SUPERIORITY_OR_OTHER|||||||0.4261||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.4261
74071377|NCT00266409|147694716|SUPERIORITY_OR_OTHER|||||||0.0231||95.0||||P-value based on ANCOVA with treatment as a fixed effect and baseline HAM-A score as a covariate|ANCOVA|||||||0.0231
74071378|NCT00266409|147694717|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and total HAM-A score as a covariate|ANCOVA|||||||0.1820
74071379|NCT00266409|147694717|SUPERIORITY_OR_OTHER|||||||0.2187||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as covariate|ANCOVA|||||||0.2187
74071380|NCT00266409|147694718|SUPERIORITY_OR_OTHER|||||||0.1456||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.1456
74071381|NCT00266409|147694718|SUPERIORITY_OR_OTHER|||||||0.3618||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3618
74071382|NCT00266409|147694719|SUPERIORITY_OR_OTHER|||||||0.3535||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3535
74071383|NCT00266409|147694719|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.5660
74071384|NCT00266409|147694720|SUPERIORITY_OR_OTHER|||||||0.3414||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3414
74071385|NCT00266409|147694720|SUPERIORITY_OR_OTHER|||||||0.7344||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.7344
74071386|NCT00266409|147694721|SUPERIORITY_OR_OTHER|||||||0.1197||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.1197
74071387|NCT00266409|147694721|SUPERIORITY_OR_OTHER|||||||0.4416||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.4416
74071388|NCT00266409|147694722|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.0350
74071389|NCT00266409|147694722|SUPERIORITY_OR_OTHER|||||||0.4205||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.4205
74071390|NCT00266409|147694723|SUPERIORITY_OR_OTHER|||||||0.2645||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.2645
74071391|NCT00266409|147694723|SUPERIORITY_OR_OTHER|||||||0.5369||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.5369
74071392|NCT00266409|147694724|SUPERIORITY_OR_OTHER|||||||0.9988||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9988
74071393|NCT00266409|147694724|SUPERIORITY_OR_OTHER|||||||0.7729||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7729
74071394|NCT00266409|147694725|SUPERIORITY_OR_OTHER|||||||0.7338||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7338
74071395|NCT00266409|147694725|SUPERIORITY_OR_OTHER|||||||0.0897||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.0897
74071396|NCT00266409|147694726|SUPERIORITY_OR_OTHER|||||||0.6501||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6501
74071397|NCT00266409|147694726|SUPERIORITY_OR_OTHER|||||||0.8196||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8196
74071398|NCT00266409|147694727|SUPERIORITY_OR_OTHER|||||||0.6404||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6404
74071399|NCT00266409|147694727|SUPERIORITY_OR_OTHER|||||||0.8263||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8263
74071400|NCT00266409|147694728|SUPERIORITY_OR_OTHER|||||||0.6946||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6946
74071401|NCT00266409|147694728|SUPERIORITY_OR_OTHER|||||||0.9629||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9629
74071402|NCT00266409|147694729|SUPERIORITY_OR_OTHER|||||||0.8617||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8617
74071403|NCT00266409|147694729|SUPERIORITY_OR_OTHER|||||||0.7555||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7555
74071404|NCT00266409|147694730|SUPERIORITY_OR_OTHER|||||||0.5836||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.5836
74071405|NCT00266409|147694730|SUPERIORITY_OR_OTHER|||||||0.9096||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9096
74071406|NCT00266409|147694731|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0002
74071407|NCT00266409|147694731|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0006
74071408|NCT00266409|147694732|SUPERIORITY_OR_OTHER|||||||0.0255||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint, CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0255
74071409|NCT00266409|147694732|SUPERIORITY_OR_OTHER|||||||0.0065||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0065
74071410|NCT00266409|147694733|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0370
74071411|NCT00266409|147694733|SUPERIORITY_OR_OTHER|||||||0.9569||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.9569
74071412|NCT00266409|147694734|SUPERIORITY_OR_OTHER|||||||0.0978||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0978
74071413|NCT00266409|147694734|SUPERIORITY_OR_OTHER|||||||0.7096||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.7096
74071414|NCT00266409|147694735|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0001
74071415|NCT00266409|147694735|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0003
74071416|NCT00266409|147694736|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0025
74071417|NCT00266409|147694736|SUPERIORITY_OR_OTHER|||||||0.0101||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0101
74071418|NCT00266409|147694737|SUPERIORITY_OR_OTHER|||||||0.0095||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0095
74071419|NCT00266409|147694737|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0390
74071420|NCT00266409|147694738|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0160
74071421|NCT00266409|147694738|SUPERIORITY_OR_OTHER|||||||0.1024||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1024
74071422|NCT00266409|147694739|SUPERIORITY_OR_OTHER|||||||0.0761||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0761
74071423|NCT00266409|147694739|SUPERIORITY_OR_OTHER|||||||0.0376||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0376
74071424|NCT00266409|147694740|SUPERIORITY_OR_OTHER|||||||0.1196||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1196
74071425|NCT00266409|147694740|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint.CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0029
73883722|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.408||||0.0018||95.0|2.379|10.436|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.436|2.379|0.0018
74071426|NCT00266409|147694741|SUPERIORITY_OR_OTHER|||||||0.6323||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.6323
74071427|NCT00266409|147694741|SUPERIORITY_OR_OTHER|||||||0.5533||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.5533
74071428|NCT00266409|147694742|SUPERIORITY_OR_OTHER|||||||0.1705||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1705
74071429|NCT00266409|147694742|SUPERIORITY_OR_OTHER|||||||0.3196||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.3196
74071430|NCT00266409|147694743|SUPERIORITY_OR_OTHER|||||||0.0419||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0419
74071431|NCT00266409|147694743|SUPERIORITY_OR_OTHER|||||||0.2541||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.2541
74071432|NCT00266409|147694744|SUPERIORITY_OR_OTHER|||||||0.0677||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0677
74071433|NCT00266409|147694744|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0273
74071434|NCT00266409|147694745|SUPERIORITY_OR_OTHER|||||||0.5153||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5153
74071435|NCT00266409|147694745|SUPERIORITY_OR_OTHER|||||||0.0122||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0122
74071436|NCT00266409|147694746|SUPERIORITY_OR_OTHER|||||||0.4648||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.4648
74071437|NCT00266409|147694746|SUPERIORITY_OR_OTHER|||||||0.5502||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5502
74071438|NCT00266409|147694747|SUPERIORITY_OR_OTHER|||||||0.9093||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.9093
74071439|NCT00266409|147694747|SUPERIORITY_OR_OTHER|||||||0.1354||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.1354
74071440|NCT00266409|147694748|SUPERIORITY_OR_OTHER|||||||0.7434||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.7434
74071441|NCT00266409|147694748|SUPERIORITY_OR_OTHER|||||||0.1148||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.1148
74071442|NCT00266409|147694749|SUPERIORITY_OR_OTHER|||||||0.9346||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A insomnia subscore as a covariate|ANCOVA|||||||0.9346
74071443|NCT00266409|147694749|SUPERIORITY_OR_OTHER|||||||0.2709||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.2709
74071444|NCT00266409|147694750|SUPERIORITY_OR_OTHER|||||||0.3827||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.3827
74071445|NCT00266409|147694750|SUPERIORITY_OR_OTHER|||||||0.2513||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.2513
74071446|NCT00266409|147694751|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.3930
74071447|NCT00266409|147694751|SUPERIORITY_OR_OTHER|||||||0.5461||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5461
74071448|NCT00266409|147694752|SUPERIORITY_OR_OTHER|||||||0.0722||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0722
74071449|NCT00266409|147694752|SUPERIORITY_OR_OTHER|||||||0.4639||95.0||||P-values based on an ANCOVA with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.4639
74071450|NCT00266409|147694753|SUPERIORITY_OR_OTHER|||||||0.0075||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0075
73883723|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.547||||0.0025||95.0|2.309|10.785|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.785|2.309|0.0025
73883724|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.624||||0.0029||95.0|2.269|10.98|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.980|2.269|0.0029
74071451|NCT00266409|147694753|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A psychic factors subscore as a covariate|ANCOVA|||||||0.1641
73883725|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.764||||0.0037||95.0|2.195|11.332|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.332|2.195|0.0037
74071452|NCT00266409|147694754|SUPERIORITY_OR_OTHER|||||||0.0932||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0932
74071453|NCT00266409|147694754|SUPERIORITY_OR_OTHER|||||||0.0852||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0852
74071454|NCT00266409|147694755|SUPERIORITY_OR_OTHER|||||||0.7896||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.7896
74071455|NCT00266409|147694755|SUPERIORITY_OR_OTHER|||||||0.9651||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.9651
74071456|NCT00266409|147694756|SUPERIORITY_OR_OTHER|||||||0.828||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.8280
74071457|NCT00266409|147694756|SUPERIORITY_OR_OTHER|||||||0.0936||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0936
74071458|NCT00266409|147694757|SUPERIORITY_OR_OTHER|||||||0.3539||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3539
74071459|NCT00266409|147694757|SUPERIORITY_OR_OTHER|||||||0.4672||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.4672
74071460|NCT00266409|147694758|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.2550
74071461|NCT00266409|147694758|SUPERIORITY_OR_OTHER|||||||0.3125||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3125
74071462|NCT00266409|147694759|SUPERIORITY_OR_OTHER|||||||0.3174||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3174
74071463|NCT00266409|147694759|SUPERIORITY_OR_OTHER|||||||0.9427||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.9427
74071464|NCT00266409|147694760|SUPERIORITY_OR_OTHER|||||||0.3252||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3252
74071465|NCT00266409|147694760|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.6090
74071466|NCT00266409|147694761|SUPERIORITY_OR_OTHER|||||||0.1247||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.1247
74071467|NCT00266409|147694761|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.8430
74071468|NCT00266409|147694762|SUPERIORITY_OR_OTHER|||||||0.1031||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1031
74071469|NCT00266409|147694762|SUPERIORITY_OR_OTHER|||||||0.0543||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0543
74071470|NCT00266409|147694763|SUPERIORITY_OR_OTHER|||||||0.0508||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0508
74071471|NCT00266409|147694763|SUPERIORITY_OR_OTHER|||||||0.0871||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0871
74071472|NCT00266409|147694764|SUPERIORITY_OR_OTHER|||||||0.8318||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.8318
74071473|NCT00266409|147694764|SUPERIORITY_OR_OTHER|||||||0.5375||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.5375
74071474|NCT00266409|147694765|SUPERIORITY_OR_OTHER|||||||0.2186||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2186
74071475|NCT00266409|147694765|SUPERIORITY_OR_OTHER|||||||0.0422||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0422
74071476|NCT00266409|147694766|SUPERIORITY_OR_OTHER|||||||0.1164||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1164
74071477|NCT00266409|147694766|SUPERIORITY_OR_OTHER|||||||0.1935||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1935
74071478|NCT00266409|147694767|SUPERIORITY_OR_OTHER|||||||0.1244||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1244
74071479|NCT00266409|147694767|SUPERIORITY_OR_OTHER|||||||0.6182||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.6182
74071480|NCT00266409|147694768|SUPERIORITY_OR_OTHER|||||||0.4589||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.4589
74071481|NCT00266409|147694768|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.3930
74071482|NCT00266409|147694769|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.4450
74071483|NCT00266409|147694769|SUPERIORITY_OR_OTHER|||||||0.2924||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2924
74071484|NCT00266409|147694770|SUPERIORITY_OR_OTHER|||||||0.2184||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2184
74071485|NCT00266409|147694770|SUPERIORITY_OR_OTHER|||||||0.1281||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.1281
74071486|NCT00266409|147694771|SUPERIORITY_OR_OTHER|||||||0.6602||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.6602
74071487|NCT00266409|147694772|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5544
74071488|NCT00266409|147694773|SUPERIORITY_OR_OTHER|||||||0.9269||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.9269
74071489|NCT00266409|147694774|SUPERIORITY_OR_OTHER|||||||0.5271||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5271
74071490|NCT00266409|147694775|SUPERIORITY_OR_OTHER|||||||0.1447||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.1447
74071491|NCT00266409|147694776|SUPERIORITY_OR_OTHER|||||||0.9375||95.0||||P-value from a Chi-squared test|Chi-squared|||||||0.9375
74071492|NCT00266409|147694777|SUPERIORITY_OR_OTHER|||||||0.9883||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.9883
74071493|NCT00266409|147694778|SUPERIORITY_OR_OTHER|||||||0.3093||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.3093
74071494|NCT00266409|147694779|SUPERIORITY_OR_OTHER|||||||0.5824||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5824
74071495|NCT00266409|147694780|SUPERIORITY_OR_OTHER|||||||0.044||95.0|||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.044
74071496|NCT00266409|147694780|SUPERIORITY_OR_OTHER|||||||0.6587||95.0|||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.6587
74071497|NCT00635154|147694784|SUPERIORITY_OR_OTHER||Proportion of confirmed responses (%)|1.8||||||95.0|0.5|10.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses to Anakinra alone was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.||10|0.5|
74071498|NCT01399736|147694791|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.22|0.55|||Chi-squared|||||0.55|0.22|<0.001
74071499|NCT01399736|147694792|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.7|TWO_SIDED|95.0|0.25|2.56|||Chi-squared|||||2.56|0.25|0.70
74071500|NCT01399736|147694793|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.25|4.01|||Chi-squared|||||4.01|0.25|1.00
74071501|NCT01399736|147694794|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.1|TWO_SIDED|95.0|0.22|1.13|||Chi-squared|||||1.13|0.22|0.10
74071502|NCT01399736|147694795|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.29|TWO_SIDED|95.0|0.22|1.59|||Chi-squared|||||1.59|0.22|0.29
74071503|NCT01399736|147694796|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.24|0.57|||Chi-squared|||||0.57|0.24|<0.001
74071504|NCT01399736|147694797|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.8|TWO_SIDED|95.0|0.29|5.02|||Chi-squared|||||5.02|0.29|0.80
74071505|NCT00948675|147694832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0|||||Log Rank|||||||0.176
74071506|NCT00948675|147694833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Log Rank|||||||0.610
74071507|NCT00948675|147694834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615||95.0|||||Log Rank|||||||0.615
74071508|NCT00948675|147694835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.414||95.0|||||Pearson Chi-square Test|||||||0.414
74071509|NCT00948675|147694836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.575||95.0|||||Pearson Chi-square Test|||||||0.575
74071510|NCT04128007|147694853|SUPERIORITY||Odds Ratio (OR)|14.65|||<|0.0001|TWO_SIDED|95.0|6.64|32.32|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|S-IGA Success at Week 8 Odds Ratio||32.32|6.64|<0.0001
74071511|NCT04128007|147694854|SUPERIORITY||Odds Ratio (OR)|8.8|||<|0.0001|TWO_SIDED|95.0|3.65|21.18|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|B-IGA Success at Week 8 Odds Ratio||21.18|3.65|<0.0001
74071512|NCT04128007|147694855|SUPERIORITY||Odds Ratio (OR)|4.06|||<|0.0001|TWO_SIDED|95.0|2.14|7.71|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 2 Odds Ratio||7.71|2.14|<0.0001
74071513|NCT04128007|147694855|SUPERIORITY||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|2.93|9.78||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 4 Odds Ratio||9.78|2.93|<0.0001
74071514|NCT04128007|147694855|SUPERIORITY||Odds Ratio (OR)|9.74|||<|0.0001|TWO_SIDED|95.0|5.02|18.89||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 8 Odds Ratio||18.89|5.02|<0.0001
74071515|NCT04128007|147694856|SUPERIORITY||Least Squares Mean Difference|-19.6|||<|0.0001|TWO_SIDED|95.0|-27.4|-11.8|||ANCOVA|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|Comparison of Week 4 Change from Baseline||-11.8|-27.4|<0.0001
74071516|NCT04128007|147694856|SUPERIORITY||Least Squares Mean Difference|-27.5|||<|0.0001|TWO_SIDED|95.0|-35.5|-19.5|||ANCOVA|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|Comparison of Week 8 Change from Baseline||-19.5|-35.5|<0.0001
74071517|NCT04128007|147694857|SUPERIORITY||Hazard Ratio (HR)|3.94|||<|0.0001|TWO_SIDED|95.0|2.764|5.616||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization.|Log Rank||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization.|Time to PSSI-50 Hazard Ratio||5.616|2.764|<0.0001
74071518|NCT04128007|147694858|SUPERIORITY||Odds Ratio (OR)|9.46|||<|0.0001|TWO_SIDED|95.0|4.81|18.61||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|PSSI-75 at Week 8 Odds Ratio||18.61|4.81|<0.0001
74071519|NCT04128007|147694859|SUPERIORITY||Odds Ratio (OR)|34.45|||<|0.0001|TWO_SIDED|95.0|8.49|139.77|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|PSSI-90 at Week 8 Odds Ratio||139.77|8.49|<0.0001
74071520|NCT01041781|147694931|SUPERIORITY||Hazard Ratio (HR)|1.076||||0.5346|TWO_SIDED|95.0|0.853|1.367|||Log Rank|||||1.367|0.853|0.5346
74071521|NCT01041781|147694935|SUPERIORITY|||||||0.0049|||||||Log Rank|||||||0.0049
74071522|NCT01041781|147694936|SUPERIORITY|||||||0.0131|||||||Log Rank|||||||0.0131
74071523|NCT01041781|147694937|SUPERIORITY|||||||0.0322|||||||Log Rank|||||||0.0322
74071524|NCT04799158|147694994|SUPERIORITY||Percentage difference|28.7|||<|0.0001|TWO_SIDED|95.0|21.84|35.55|||Fisher Exact|||||35.55|21.84|<0.0001
74071525|NCT04799158|147694994|SUPERIORITY||Percentage difference|33.3|||<|0.0001|TWO_SIDED|95.0|26.28|40.23|||Fisher Exact|||||40.23|26.28|<0.0001
74071526|NCT04799158|147694994|SUPERIORITY||Percentage difference|42.7|||<|0.0001|TWO_SIDED|95.0|35.92|49.42|||Fisher Exact|||||49.42|35.92|<0.0001
74071527|NCT04799158|147694995|SUPERIORITY||Percentage difference|30.3|||<|0.0001|TWO_SIDED|95.0|23.41|37.09|||Fisher Exact|||||37.09|23.41|<0.0001
74071528|NCT04799158|147694995|SUPERIORITY||Percentage difference|23.9|||<|0.0001|TWO_SIDED|95.0|16.67|31.05|||Fisher Exact|||||31.05|16.67|<0.0001
74071529|NCT04799158|147694995|SUPERIORITY||Percentage difference|37.7|||<|0.0001|TWO_SIDED|95.0|31.0|44.35|||Fisher Exact|||||44.35|31.00|<0.0001
73883726|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.841||||0.0042||95.0|2.153|11.529|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.529|2.153|0.0042
74071530|NCT04799158|147694996|SUPERIORITY|||||||0.1771|||||||Wilcoxon rank-sum test|||||||0.1771
74071531|NCT04799158|147694996|SUPERIORITY|||||||0.1551|||||||Wilcoxon rank-sum test|||||||0.1551
74071532|NCT04799158|147694996|SUPERIORITY|||||||0.0094|||||||Wilcoxon rank-sum test|||||||0.0094
74071533|NCT04799158|147694997|SUPERIORITY|||||||0.3395|||||||Wilcoxon rank-sum test|||||||0.3395
74071534|NCT04799158|147694997|SUPERIORITY|||||||0.4882|||||||Wilcoxon rank-sum test|||||||0.4882
74071535|NCT04799158|147694997|SUPERIORITY|||||||0.0722|||||||Wilcoxon rank-sum test|||||||0.0722
74071536|NCT04799158|147694998|SUPERIORITY||Percentage difference|-3.9||||0.83|TWO_SIDED|95.0|-24.41|16.52|||Fisher Exact|||||16.52|-24.41|0.8300
74071537|NCT04799158|147694998|SUPERIORITY||Percentage difference|1.4|||>|0.9999|TWO_SIDED|95.0|-19.28|22.16|||Fisher Exact|||||22.16|-19.28|>0.9999
74071538|NCT04799158|147694998|SUPERIORITY||Percentage difference|2.3|||>|0.9999|TWO_SIDED|95.0|-18.22|22.88|||Fisher Exact|||||22.88|-18.22|>0.9999
74071539|NCT04799158|147694999|SUPERIORITY|||||||0.4684|||||||Wilcoxon rank-sum test|||||||0.4684
74071540|NCT04799158|147694999|SUPERIORITY|||||||0.656|||||||Wilcoxon rank-sum test|||||||0.6560
74071541|NCT04799158|147694999|SUPERIORITY|||||||0.6324|||||||Wilcoxon rank-sum test|||||||0.6324
74071542|NCT04799158|147695000|SUPERIORITY|||||||0.9896|||||||Wilcoxon rank-sum test|||||||0.9896
74071543|NCT04799158|147695000|SUPERIORITY|||||||0.6916|||||||Wilcoxon rank-sum test|||||||0.6916
74071544|NCT04799158|147695000|SUPERIORITY|||||||0.9316|||||||Wilcoxon rank-sum test|||||||0.9316
74071545|NCT00918567|147695030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|1.93|<|0.05|TWO_SIDED|||||Also tested marginal effects defined as p \< .10.|Mixed Models Analysis|Tukey-Kramer adjustments for post-hoc differences of least squares comparisons||||||<.05
74071546|NCT00918567|147695031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.51|<|0.05|TWO_SIDED|||||Also examined marginal effects, defined as p\<.10|Mixed Models Analysis|||||||<.05
74071547|NCT00918567|147695032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.6|<|0.05|TWO_SIDED|||||Also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
74071548|NCT00918567|147695033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.09|<|0.05|TWO_SIDED|||||Also estimated marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
74071549|NCT00918567|147695034|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|||||also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
74071550|NCT00918567|147695035|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED|||||Also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||>.05
74071551|NCT00918567|147695036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
74071552|NCT00918567|147695037|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<0.05
74071553|NCT00918567|147695038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|1.8|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
74071554|NCT00918567|147695039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||Also tested marginal effect (p\<.10)|Mixed Models Analysis|||||||<.05
74071555|NCT00918567|147695040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.19|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
74071556|NCT02099461|147695068|SUPERIORITY_OR_OTHER||LS Mean|0.15||||0.2966|TWO_SIDED|95.0|-0.136|0.441|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.441|-0.136|0.2966
74071557|NCT02099461|147695068|SUPERIORITY_OR_OTHER||LS Mean|-0.16||||0.2769|TWO_SIDED|95.0|-0.447|0.13|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.130|-0.447|0.2769
74071558|NCT02099461|147695068|SUPERIORITY_OR_OTHER||LS Mean|-0.09||||0.5238|TWO_SIDED|95.0|-0.373|0.191|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.191|-0.373|0.5238
74071559|NCT02099461|147695068|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31||||0.1343|TWO_SIDED|95.0|-0.72|0.098|||ANCOVA||Denosumab 60 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.098|-0.720|0.1343
74071560|NCT02099461|147695068|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24||||0.2345|TWO_SIDED|95.0|-0.646|0.161|||ANCOVA||Denosumab 120 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.161|-0.646|0.2345
74071561|NCT00720122|147695069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.00558|STANDARD_ERROR_OF_MEAN|0.00653||0.4|TWO_SIDED|95.0|-0.0081|0.0193|||Paired t-test|||A paired t-test was performed. The null hypothesis was that bone density would decrease over 6 months in females with anorexia nervosa, as observed in life course studies.||0.0193|-0.0081|0.40
74071562|NCT03008460|147695070|NON_INFERIORITY|Non-inferiority would be demonstrated if the lower limit of the 95% confidence interval of the adjusted treatment difference was higher than -15%.|Adjusted treatment difference|-7.61||||0.0907|TWO_SIDED|95.0|-18.45|3.24||P-value for non-inferiority was estimated from the adjusted treatment difference.|Regression, Logistic|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a logistic regression model, including treatment and country as covariates.||3.24|-18.45|0.0907
74071563|NCT03008460|147695071|OTHER||Adjusted treatment difference|-0.18||||0.0428|TWO_SIDED|95.0|-0.36|-0.01|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||-0.01|-0.36|0.0428
74071564|NCT03008460|147695072|OTHER||Adjusted treatment difference|-0.07||||0.4676|TWO_SIDED|95.0|-0.25|0.12|||ANOVA|||"Left colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.12|-0.25|0.4676
74071565|NCT03008460|147695072|OTHER||Adjusted treatment difference|-0.09||||0.3076|TWO_SIDED|95.0|-0.25|0.08|||ANOVA|||"Transverse colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.08|-0.25|0.3076
74071566|NCT03008460|147695072|OTHER||Adjusted treatment difference|-0.24||||0.0155|TWO_SIDED|95.0|-0.44|-0.05|||ANOVA|||"Right colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||-0.05|-0.44|0.0155
74071567|NCT03008460|147695072|OTHER||Adjusted treatment difference|-0.36||||0.0975|TWO_SIDED|95.0|-0.79|0.07|||ANOVA|||"Global score:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.07|-0.79|0.0975
74071568|NCT03008460|147695073|OTHER||Adjusted treatment difference rate|1.3847||||0.2428|TWO_SIDED|95.0|0.8|2.4|||CMH chi-square|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) chi-square method (using the general association statistic), stratified on country.||2.4|0.8|0.2428
74071569|NCT03008460|147695074|OTHER||Adjusted treatment difference rate|24.0219|||<|0.0001|TWO_SIDED|95.0|12.6|45.9|||CMH chi-square|||Analysis was performed using CMH chi-square method (using the general association statistic), stratified on country.||45.9|12.6|<0.0001
74071570|NCT03008460|147695075|OTHER||Adjusted treatment difference rate|1.0022||||0.9257|TWO_SIDED|95.0|1.0|1.1|||CMH chi-square|||Analysis was performed using CMH chi-square method (using the general association statistic), stratified on country.||1.1|1.0|0.9257
74071571|NCT03008460|147695077|OTHER||Adjusted treatment difference|-0.93||||0.4459|TWO_SIDED|95.0|-3.32|1.47|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||1.47|-3.32|0.4459
74071572|NCT03008460|147695078|OTHER||Adjusted treatment difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.4|1.03|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||1.03|0.40|<0.0001
74071573|NCT03008460|147695079|OTHER||Adjusted treatment difference rate|1.22||||0.3945|TWO_SIDED|95.0|-1.6|4.05|||ANOVA|||"Dose 1:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||4.05|-1.60|0.3945
74071574|NCT03008460|147695079|OTHER||Adjusted treatment difference rate|6.38||||0.0085|TWO_SIDED|95.0|1.65|11.12|||ANOVA|||"Dose 2:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||11.12|1.65|0.0085
73883727|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.98||||0.0053||95.0|2.076|11.884|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.884|2.076|0.0053
73883728|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.057||||0.0059||95.0|2.032|12.083|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.083|2.032|0.0059
74071575|NCT03008460|147695079|OTHER||Adjusted treatment difference rate|7.48||||0.0036|TWO_SIDED|95.0|2.46|12.5|||ANOVA|||"Global:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||12.50|2.46|0.0036
74071576|NCT03008460|147695082|OTHER||Adjusted treatment difference|1.05||||0.0015|TWO_SIDED|95.0|0.41|1.69|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using 2-way ANOVA, including treatment and country as covariates.||1.69|0.41|0.0015
74071577|NCT01919190|147695089|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.8|TWO_SIDED||||||ANCOVA|||||||>0.8
74071578|NCT01919190|147695090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0456|TWO_SIDED||||||Mixed Models Analysis|||||||0.0456
74071579|NCT02207231|147695102|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||<0.001
74071580|NCT02207231|147695103|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||<0.001
74071581|NCT02207231|147695104|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
74071582|NCT02207231|147695104|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
74071583|NCT02207231|147695105|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
74071584|NCT02207231|147695105|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
74071585|NCT02207231|147695106|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
74071586|NCT02207231|147695106|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
74071587|NCT02207231|147695107|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).||||< 0.001
74071588|NCT02207231|147695108|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10.0%|Difference in Percentage|19.3|||<|0.001|TWO_SIDED|95.0|12.9|25.7|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).||25.7|12.9|< 0.001
74071589|NCT02207231|147695108|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
74071590|NCT02207231|147695109|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10.0%|Difference in Percentage|24.1|||<|0.001|TWO_SIDED|95.0|17.0|31.0|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||31.0|17.0|< 0.001
74071591|NCT02207231|147695109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
74071592|NCT02207231|147695110|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10%|Difference in percentage|18.0|||<|0.001|TWO_SIDED|95.0|12.4|23.8|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||23.8|12.4|< 0.001
74071593|NCT02207231|147695110|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
74071594|NCT02207231|147695111|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
74071595|NCT02207231|147695112|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).||||< 0.001
74071596|NCT02207231|147695113|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
74071597|NCT00502775|147695124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.16|<|0.001||95.0|-1.2|-0.6||Symptom scores were grouped in 3 families: nasal, ocular, instantaneous. Within each family, results of hypothesis tests were adjusted using Hochberg's method.|ANCOVA|No other strata or covariates, other than investigator, were defined.|Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Fexofenadine|The primary efficacy measure, mean change from baseline over the two-week treatment period in NSS compared between fluticasone furoate and fexofenadine, was assessed at a significance level of α=0.05. If the null hypothesis of this comparison was rejected, then the secondary measures were subject to hypothesis testing. The study was powered at 90%.||-0.6|-1.2|<0.001
74071598|NCT00502775|147695124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.16|<|0.001||95.0|-1.1|-0.4|||ANCOVA||Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Placebo|||-0.4|-1.1|<0.001
74071599|NCT00502775|147695124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.374||95.0|-0.2|0.5|||ANCOVA||Mean Difference = Mean Change in Fexofenadine - Mean Change in Placebo|||0.5|-0.2|0.374
74071600|NCT00655642|147695140|NON_INFERIORITY_OR_EQUIVALENCE|Based on the aforementioned values, we calculated a sample size for each treatment arm of 131 patients. We increased this sample estimate to 150 per treatment arm (total of 600 patients) to account for anticipated study attrition. Based on an unplanned interim conditional power futility analysis done at 30% information fraction, the decision was made to end the trial early.The futility analysis found the observed differences were far less than what was deemed clinically important.|Median Difference (Final Values)|12.0|STANDARD_DEVIATION|25.0||0.16||||||Being aware of the multiple comparison issues, we deliberately chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.|Kruskal-Wallis|We computed the effect of the 3 treatments relative to ondansetron.|Change in VAS score was calculated as (VAS 30 min - VAS baseline). We calculated the differences in median VAS reductions for each arm relative to ondansetron.|The null hypothesis is that ondanestron is not more effective in reducing nausea than metoclopramide, promethazine or isotonic normal saline. The sample size was chosen to detect a 12-mm difference in VAS improvement between ondanestron and any other treatment arm (assuming a SD of 25mm) at 90% power and 0.01 alpha significance level. We chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.||||0.16
74071601|NCT00262600|147695149|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.9|||<|0.0001||95.0|0.74|1.1||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 110 mg to warfarin||1.10|0.74|<.0001
74071602|NCT00262600|147695149|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.65|||<|0.0001||95.0|0.52|0.81||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 150 mg to warfarin||0.81|0.52|<.0001
74071603|NCT00262600|147695150|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.2206||95.0|0.83|1.04||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||1.04|0.83|0.2206
74071604|NCT00262600|147695150|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.0015||95.0|0.74|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||0.93|0.74|0.0015
74071605|NCT00262600|147695151|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.7508||95.0|0.87|1.11||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||1.11|0.87|0.7508
74071606|NCT00262600|147695151|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.0093||95.0|0.74|0.96||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||0.96|0.74|0.0093
74071607|NCT00262600|147695152|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.0026||95.0|0.7|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds||0.93|0.70|0.0026
73883729|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.197||||0.0072||95.0|1.953|12.441|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.441|1.953|0.0072
74071608|NCT00262600|147695152|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.3146||95.0|0.81|1.07||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds||1.07|0.81|0.3146
74071609|NCT00262600|147695153|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.3|||<|0.0001||95.0|0.19|0.45||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH||0.45|0.19|<0.0001
74071610|NCT00262600|147695153|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.41|||<|0.0001||95.0|0.28|0.6||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH||0.60|0.28|<0.0001
73883730|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.274||||0.0079||95.0|1.908|12.64|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.640|1.908|0.0079
74071611|NCT02906709|147695155|SUPERIORITY||Difference in the Least Squares Means|-0.9|||<|0.001|TWO_SIDED|95.0|-1.15|-0.66|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior anti-hyperglycemic agent (AHA) therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|-0.66|-1.15|<0.001
74071612|NCT02906709|147695156|SUPERIORITY||Difference in % vs. Placebo|7.0|||||TWO_SIDED|95.0|-8.4|21.8|||||||Based on Miettinen \& Nurminen method.|21.8|-8.4|
74071613|NCT02906709|147695158|SUPERIORITY||Difference in % vs. Placebo|-4.1|||||TWO_SIDED|95.0|-12.8|0.4|||||||Based on Miettinen \& Nurminen method.|0.4|-12.8|
74071614|NCT02906709|147695160|SUPERIORITY||Difference in the Least Squares Means|-15.0||||0.002|TWO_SIDED|95.0|-24.5|-5.4|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|-5.4|-24.5|0.002
74071615|NCT02906709|147695161|SUPERIORITY||Percent Between-group Rate Difference|5.8||||0.065|TWO_SIDED|95.0|-0.7|11.5|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen \& Nurminen method.|11.5|-0.7|0.065
73883731|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.413||||0.0093||95.0|1.826|13.0|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.000|1.826|0.0093
74071616|NCT02906709|147695162|SUPERIORITY||Percent Between-group Rate Difference|1.6||||0.334|TWO_SIDED|95.0|-4.7|5.8|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen \& Nurminen method.|5.8|-4.7|0.334
74071617|NCT02906709|147695163|SUPERIORITY||Difference in the Least Squares Means|3.1|||<|0.001|TWO_SIDED|95.0|2.3|4.0|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|4.0|2.3|<0.001
74071618|NCT02428699|147695178|SUPERIORITY||Mean Difference (Net)|5.16|||<|0.0001|TWO_SIDED|95.0|2.79|7.53|||ANCOVA|Subject as random effect,treatment and period as fixed effects,subject and period level baseline values for plasma total and free acids as covariates|Difference is test minus reference such that a positive difference favors the test treatment.|||7.53|2.79|<.0001
73883732|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.491||||0.0101||95.0|1.78|13.201|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.201|1.780|0.0101
73883733|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.63||||0.0117||95.0|1.697|13.562|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.562|1.697|0.0117
74071619|NCT02483975|147695199|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.92|||||TWO_SIDED|95.0|0.804|1.0505||||||||1.0505|0.8040|
74071620|NCT02483975|147695200|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.93|||||TWO_SIDED|95.0|0.8096|1.062||||||||1.0620|0.8096|
74071621|NCT02483975|147695201|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.93|||||TWO_SIDED|95.0|0.81|1.06||||||||1.06|0.81|
74071622|NCT02483975|147695202|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.79|||||TWO_SIDED|95.0|0.61|1.03||||||||1.03|0.61|
74071623|NCT02483975|147695203|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||||1.07|0.72|
74071624|NCT01901055|147695236|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.18||0.017|TWO_SIDED|95.0|-0.68|0.04||F-test statistics for group X time = 4.27|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|Statistical analyses were revised from the original protocol for reporting results at 24 week because unable to recruit an adequate sample size at this time point of participants originally on CPAP for 24 weeks and those who were in the original sham-CPAP group who crossed over to CPAP and completed 24 weeks of treatment.||0.04|-0.68|0.017
74071625|NCT01901055|147695237|SUPERIORITY||Mean Difference (Net)|-16.78|STANDARD_ERROR_OF_MEAN|10.99||0.307|TWO_SIDED|95.0|-38.66|5.09||F test statistics for group X time = 1.20|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||5.09|-38.66|0.307
74071626|NCT01901055|147695238|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.3||0.732|TWO_SIDED|95.0|-0.85|0.35||F test statistics for group X time = 0.31|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.35|-0.85|0.732
74071627|NCT01901055|147695239|SUPERIORITY||Mean Difference (Net)|3.65|STANDARD_ERROR_OF_MEAN|2.65||0.919|TWO_SIDED|95.0|-1.62|8.92||F test statistics for group X time = 0.01|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||8.92|-1.62|0.919
74071628|NCT01901055|147695240|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.54||0.125|TWO_SIDED|95.0|-1.18|0.96||F-test statistics for group X time = 2.12|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.96|-1.18|0.125
74071629|NCT01901055|147695241|SUPERIORITY||Mean Difference (Net)|87.22|STANDARD_ERROR_OF_MEAN|529.1||0.639|TWO_SIDED|95.0|-936.1|1137.5||F-test statistics for group X time = 0.45|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1137.50|-936.10|0.639
74071630|NCT01901055|147695242|SUPERIORITY||Mean Difference (Net)|-0.63|STANDARD_ERROR_OF_MEAN|0.49||0.461|TWO_SIDED|95.0|-1.61|0.35||F-test statistics for group X time = 0.78|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.35|-1.61|0.461
74071631|NCT01901055|147695243|SUPERIORITY||Mean Difference (Net)|3.04|STANDARD_ERROR_OF_MEAN|3.94||0.776|TWO_SIDED|95.0|-4.78|10.86||F-test statistics for group X time= 0.25|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||10.86|-4.78|0.776
74071632|NCT01901055|147695244|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.79||0.378|TWO_SIDED|95.0|-1.24|1.89||F-test statistics for group X time = 0.98|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1.89|-1.24|0.378
74071633|NCT01901055|147695245|SUPERIORITY||Mean Difference (Net)|3.18|STANDARD_ERROR_OF_MEAN|7.24||0.213|TWO_SIDED|95.0|-11.19|17.56||F-test statistics for group X time = 1.57|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||17.56|-11.19|0.213
74071634|NCT01901055|147695246|SUPERIORITY||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.64||0.005|TWO_SIDED|95.0|-1.27|1.28||F-test statistics for group X time = 5.66|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1.28|-1.27|0.005
74071635|NCT03312257|147695270|OTHER|Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.|Mean Difference (Final Values)|0.03||||0.7|TWO_SIDED|95.0|-0.14|0.21|||Repeated measures analyses|||||0.21|-0.14|0.70
74071636|NCT03312257|147695271|OTHER|Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.|Mean Difference (Final Values)|-0.08||||0.054|TWO_SIDED|95.0|-0.16|0.002|||Repeated measures analyses|||||0.002|-0.16|0.054
74071637|NCT02660242|147695272|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Mixed model w/ repeated measures to account for correlation from cross-over design and multiple measures, adjusting for baseline glucose and period.||The mini-dose glucagon (MDG) condition was compared with each of the conditions. In the event that exercise was terminated early due to glucose \<70 mg/dL and the participant was treated for hypoglycemia (or if participant was treated for hypoglycemia during early recovery \[prior to the meal\]), the nadir glucose value was carried forward through the end of early recovery.||||<0.001
74071638|NCT02660242|147695273|OTHER|||||||0.99|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose||||||0.99
74071639|NCT02660242|147695274|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose||||||0.15
74071640|NCT02660242|147695275|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.99
74071641|NCT02660242|147695276|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.43
74071642|NCT02660242|147695277|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.16
74071643|NCT02660242|147695278|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.69
74071644|NCT02660242|147695279|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.67
74071645|NCT02660242|147695280|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.84
74071646|NCT02660242|147695281|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.63
74071647|NCT02660242|147695282|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.24
74071648|NCT02660242|147695283|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.26
74071649|NCT00571428|147695290|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.011||||||90.0|-0.015|0.037|||Mixed Models Analysis|Treatment group, treatment sequence, predose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect.||||0.037|-0.015|
74071650|NCT00571428|147695291|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.062||||||90.0|0.035|0.09|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.090|0.035|
74071651|NCT00571428|147695292|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.035||||||90.0|-0.079|0.008|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.008|-0.079|
74071652|NCT00571428|147695293|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.03||||||90.0|-0.086|0.026|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.026|-0.086|
74071653|NCT00571428|147695298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.694||||||90.0|0.525|2.862|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect.||||2.862|0.525|
74071654|NCT00571428|147695299|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.052||||||90.0|0.015|0.09|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect||||0.090|0.015|
74071655|NCT02129348|147695319|SUPERIORITY||Treatment Effect Difference|0.7||||0.53|TWO_SIDED|95.0|-1.4|2.7||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||Lithium will significantly reduce agitation/aggression compared to placebo. In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||2.7|-1.4|0.53
74071656|NCT02129348|147695320|SUPERIORITY||Treatment Effect Difference|2.11||||0.26|TWO_SIDED|95.0|0.73|6.13||The threshold for statistical significance was p = 0.05.|Chi-squared||Odds ratio and its 95% confidence interval were computed.|Change in both NPI core score (≥30% versus \<30%) and CGI behavior change (1 or 2 versus ≥3) were required for response; these two measures were then analyzed separately. A x² test was used to identify whether there was a change in NPI core scores and CGI scores from baseline to week 12.||6.13|0.73|0.26
74071657|NCT02129348|147695321|SUPERIORITY||Treatment Effect Difference|1.79||||0.25|TWO_SIDED|95.0|0.64|5.04||The threshold of statistical significance was p = 0.05.|Chi-squared|||CGI behavior change scores were categorized into responders versus non-responders (1 or 2 versus ≥3) using the last variable observation for drop-outs. A x² test was used to identify the percentage of participants in each group, lithium versus placebo, that improved from baseline to week 12.||5.04|0.64|0.25
74071658|NCT02129348|147695322|SUPERIORITY||Treatment Effect Difference|2.0||||0.21|TWO_SIDED|95.0|-1.1|5.1||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||5.1|-1.1|0.21
74071659|NCT02129348|147695323|SUPERIORITY||Treatment Effect Difference|-0.1||||0.91|TWO_SIDED|95.0|-2.6|2.4||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||2.4|-2.6|0.91
74071660|NCT02129348|147695324|SUPERIORITY||Treatment Effect Difference|0.1||||0.94|TWO_SIDED|95.0|-1.5|1.4||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Effect size (d)= -0.02 (Cohen's D)|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||1.4|-1.5|0.94
74071661|NCT02129348|147695325|SUPERIORITY||Treatment Effect Difference|0.2||||0.63|TWO_SIDED|95.0|-0.4|0.8||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||0.8|-0.4|0.63
73883734|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.707||||0.0126||95.0|1.65|13.764|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.764|1.650|0.0126
74071662|NCT02129348|147695326|SUPERIORITY||Treatment Effect Difference|3.2||||0.24|TWO_SIDED|95.0|-2.1|8.4||The threshold of statistical significance was p = 0.05.|Mixed Models Analysis||Effect size (d)= 0.44 (Cohen's D)|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||8.4|-2.1|0.24
74071663|NCT02129348|147695327|SUPERIORITY||Treatment Effect Difference|0.0||||0.96|TWO_SIDED|95.0|-1.7|1.8||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Cohen's d=0.01|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||1.8|-1.7|0.96
74071664|NCT02129348|147695328|SUPERIORITY||Treatment Effect Difference|2.2||||0.35|TWO_SIDED|95.0|-2.3|6.6||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Cohen's d=0.35|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||6.6|-2.3|0.35
74071665|NCT03587207|147695359|OTHER|rMenBOMV+ACWY\_S is to be declared statistically inferior if the 2-sided 80% CIs of the between group ratio of the GMT with rMenBOMV+ACWY\_D as control is lower than 1 at 1 month after last vaccination. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|0.96|||||TWO_SIDED|80.0|0.83|1.1|||ANCOVA|An interaction between strain and pre-vaccination log transformed titer is included in the model to fit to the serogroup B test strain data only.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the pooled B strains, one month after last vaccination.||1.10|0.83|
74071666|NCT03587207|147695360|OTHER|M14459 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|1.0|||||TWO_SIDED|80.0|0.84|1.2|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.20|0.84|
74071667|NCT03587207|147695360|OTHER|96217 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|1.05||||||80.0|0.88|1.26|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.26|0.88|
74071668|NCT03587207|147695360|OTHER|NZ98/254 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.64|0.95|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.95|0.64|
74071669|NCT03587207|147695360|OTHER|M07-0241084 strain- Between group ratios for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.66|0.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.96|0.66|
74071670|NCT03587207|147695360|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.92|||||TWO_SIDED|80.0|0.74|1.14|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup A, one month after last vaccination.||1.14|0.74|
74071671|NCT03587207|147695360|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|1.0|||||TWO_SIDED|80.0|0.78|1.27|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup C, one month after last vaccination.||1.27|0.78|
74071672|NCT03587207|147695360|OTHER|Serogroup W- Between group ratios for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.97|||||TWO_SIDED|80.0|0.79|1.18|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup W, one month after last vaccination.||1.18|0.79|
74071673|NCT03587207|147695360|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.91|||||TWO_SIDED|80.0|0.69|1.19|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup Y, one month after last vaccination.||1.19|0.69|
74071674|NCT03587207|147695360|OTHER|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.86|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.22|0.86|
74071675|NCT03587207|147695360|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.79|||||TWO_SIDED|80.0|0.66|0.95|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA)strain, one month after last vaccination.||0.95|0.66|
74071676|NCT03587207|147695360|OTHER|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.79|||||TWO_SIDED|80.0|0.65|0.97|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.97|0.65|
74071677|NCT03587207|147695360|NON_INFERIORITY|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.73|||||TWO_SIDED|80.0|0.6|0.88|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.88|0.60|
73883735|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.846||||0.0144||95.0|1.565|14.127|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.127|1.565|0.0144
74071678|NCT03587207|147695360|OTHER|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.56|||||TWO_SIDED|80.0|0.45|0.69|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogrpoup A, one month after last vaccination.||0.69|0.45|
74071679|NCT03587207|147695360|OTHER|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.19|||||TWO_SIDED|80.0|0.94|1.52|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after last vaccination.||1.52|0.94|
74071680|NCT03587207|147695360|OTHER|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.06|||||TWO_SIDED|80.0|0.87|1.29|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after last vaccination.||1.29|0.87|
74071681|NCT03587207|147695360|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.18|||||TWO_SIDED|80.0|0.9|1.55|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after last vaccination.||1.55|0.90|
74071682|NCT03587207|147695360|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.85|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459(fHbp) strain, one month after last vaccination.||1.22|0.85|
74071683|NCT03587207|147695360|OTHER|96217 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.9|||||TWO_SIDED|80.0|0.75|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.09|0.75|
74071684|NCT03587207|147695360|OTHER|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.64|0.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.96|0.64|
74071685|NCT03587207|147695360|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.71|||||TWO_SIDED|80.0|0.58|0.86|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.86|0.58|
74071686|NCT03587207|147695360|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|3.6|||||TWO_SIDED|80.0|2.9|4.47|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||4.47|2.90|
74071687|NCT03587207|147695360|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|4.18|||||TWO_SIDED|80.0|3.28|5.31|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||5.31|3.28|
74071688|NCT03587207|147695360|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|3.07|||||TWO_SIDED|80.0|2.52|3.73|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.73|2.52|
74071689|NCT03587207|147695360|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|2.01|||||TWO_SIDED|80.0|1.53|2.65|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||2.65|1.53|
74071690|NCT03587207|147695360|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.85|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.22|0.85|
74071691|NCT03587207|147695360|OTHER|96217 strain- Between group ratios for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.86|||||TWO_SIDED|80.0|0.71|1.04|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.04|0.71|
74071692|NCT03587207|147695360|OTHER|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|1.01|||||TWO_SIDED|80.0|0.82|1.24|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||1.24|0.82|
74071693|NCT03587207|147695360|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|0.89|||||TWO_SIDED|80.0|0.73|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||1.09|0.73|
74071694|NCT03587207|147695360|OTHER|Serogroup A-Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|3.92|||||TWO_SIDED|80.0|3.15|4.88|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||4.88|3.15|
74071695|NCT03587207|147695360|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|4.19|||||TWO_SIDED|80.0|3.3|5.34|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||5.34|3.30|
74071696|NCT03587207|147695360|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|3.17|||||TWO_SIDED|80.0|2.6|3.87|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.87|2.60|
74071697|NCT03587207|147695360|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|2.22|||||TWO_SIDED|80.0|1.68|2.92|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||2.92|1.68|
74071698|NCT03587207|147695360|OTHER|M14459- Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|1.05|||||TWO_SIDED|80.0|0.87|1.25|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.25|0.87|
74071699|NCT03587207|147695360|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV group.|Geometric mean ratio|0.71|||||TWO_SIDED|80.0|0.59|0.86|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||0.86|0.59|
74071700|NCT03587207|147695360|OTHER|NZ98/254 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.62|||||TWO_SIDED|80.0|0.5|0.76|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.76|0.50|
74071701|NCT03587207|147695360|OTHER|M07-0241084 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.52|||||TWO_SIDED|80.0|0.42|0.63|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.63|0.42|
74071702|NCT03587207|147695360|OTHER|Serogroup A- Between group ratios for comparison between MenABCWY group and MenACWY group|Geometric mean ratio|2.02|||||TWO_SIDED|80.0|1.62|2.51|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||2.51|1.62|
74071703|NCT03587207|147695360|OTHER|Serogroup C- Between group ratios for comparison of MenABCWY group and MenACWY group|Odds Ratio (OR)|4.99|||||TWO_SIDED|80.0|3.92|6.35|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||6.35|3.92|
73883736|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.924||||0.0153||95.0|1.518|14.329|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.329|1.518|0.0153
73883737|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.063||||0.0172||95.0|1.432|14.693|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.693|1.432|0.0172
73883738|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.14||||0.0182||95.0|1.384|14.896|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.896|1.384|0.0182
73883739|NCT00083889|147300801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.279||||0.0201||95.0|1.297|15.261|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||15.261|1.297|0.0201
73883740|NCT00310765|147300853|SUPERIORITY_OR_OTHER_LEGACY|The group-by-time interaction result from repeated-measure analysis of variance modeling was used to evaluate whether the two study groups differed regarding the pain score change that occurred across each of the two study phases (weeks 0-7 and weeks 7-10). To conform to the analysis of variance assumption of distributional normality, the pain scores were square root transformed before the analysis.|Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.5|<|0.05|TWO_SIDED|95.0|0.0|4.0|||ANOVA|||The number of patients required per treatment group to achieve a \>80% power with an alpha=0.05 were based on exact rates from reference articles cited in the paper. Patients were randomly assigned to active drug (pregabalin) or look alike placebo.||4.0|0.0|<0.05
74071704|NCT03587207|147695360|OTHER|Serogroup W- Between group ratios for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|3.25|||||TWO_SIDED|80.0|2.66|3.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.96|2.66|
74071705|NCT03587207|147695360|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|2.38|||||TWO_SIDED|80.0|1.81|3.12|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||3.12|1.81|
74071706|NCT03587207|147695364|OTHER|Between group ratio is calculated as GMT for rMenBOMV+ACWY\_S Group over GMT for rMenBOMV+ACWY\_D Group. 80% CI are obtained from Analysis of Covariance model fitted to pooled Serogroup B Strains. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.86|1.22|||ANCOVA|An interaction between strain and pre-vaccination log transformed titer is included in the model to fit to the serogroup B test strain data only.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the pooled B strains, one month after first vaccination.||1.22|0.86|
74071707|NCT03587207|147695365|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|1.29|||||TWO_SIDED|80.0|1.02|1.63|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.63|1.02|
74071708|NCT03587207|147695365|OTHER|96217 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.93|||||TWO_SIDED|80.0|0.75|1.15|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.15|0.75|
74071709|NCT03587207|147695365|OTHER|NZ98/254 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|1.01|||||TWO_SIDED|80.0|0.8|1.29|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA)strain, one month after first vaccination.||1.29|0.80|
74071710|NCT03587207|147695365|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Odds Ratio (OR)|1.08|||||TWO_SIDED|80.0|0.87|1.36|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.36|0.87|
74071711|NCT03587207|147695365|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.77|||||TWO_SIDED|80.0|0.58|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup A, one month after first vaccination.||1.03|0.58|
73883741|NCT00310765|147300854|SUPERIORITY_OR_OTHER_LEGACY|The group-by-time interaction result from repeated-measures analysis of variance modeling was used to evaluate whether the two study groups differed regarding the sleep score change that occurred during the two study phases (weeks 0-7 and weeks 7-11. to conform to the analysis of variance assumption of distributional normality the sleep scores were square root transformed before the analysis.|Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.5|<|0.05|TWO_SIDED|95.0|0.0|4.0|||ANOVA|||The number of patients required per treatment group to achieve a \>80% power with an alpha=0.05 were based on the exact rates from the reference articles cited in the paper.||4.0|0.0|<0.05
74071712|NCT03587207|147695365|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D Group.|Geometric mean ratio|0.84|||||TWO_SIDED|80.0|0.62|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup C, one month after first vaccination.||1.13|0.62|
74071713|NCT03587207|147695365|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.88|||||TWO_SIDED|80.0|0.68|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup W, one month after first vaccination.||1.13|0.68|
74071714|NCT03587207|147695365|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.76|||||TWO_SIDED|80.0|0.54|1.08|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup Y, one month after first vaccination.||1.08|0.54|
74071715|NCT03587207|147695365|OTHER|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.87|||||TWO_SIDED|80.0|0.69|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.09|0.69|
74071716|NCT03587207|147695365|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.73|||||TWO_SIDED|80.0|0.58|0.9|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||0.90|0.58|
74071717|NCT03587207|147695365|OTHER|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.61|1.0|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.00|0.61|
74071718|NCT03587207|147695365|OTHER|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.86|||||TWO_SIDED|80.0|0.68|1.07|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.07|0.68|
74071719|NCT03587207|147695365|OTHER|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.46|||||TWO_SIDED|80.0|0.35|0.62|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup A, one month after first vaccination.||0.62|0.35|
74071720|NCT03587207|147695365|OTHER|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.22|||||TWO_SIDED|80.0|0.91|1.65|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after first vaccination.||1.65|0.91|
74071721|NCT03587207|147695365|OTHER|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.34|||||TWO_SIDED|80.0|1.04|1.72|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after first vaccination.||1.72|1.04|
74071722|NCT03587207|147695365|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.98|||||TWO_SIDED|80.0|0.7|1.38|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after first vaccination.||1.38|0.70|
74071723|NCT03587207|147695365|OTHER|M14459 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group.|Geometric mean ratio|1.05|||||TWO_SIDED|80.0|0.83|1.32|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.32|0.83|
74071724|NCT03587207|147695365|OTHER|96217 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.64|1.0|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.00|0.64|
74071725|NCT03587207|147695365|OTHER|NZ98/254 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.88|||||TWO_SIDED|80.0|0.69|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.13|0.69|
74071726|NCT03587207|147695365|OTHER|M07-0241084 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.95|||||TWO_SIDED|80.0|0.76|1.19|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.19|0.76|
74071727|NCT03587207|147695365|OTHER|M14459 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.81|||||TWO_SIDED|80.0|0.64|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.03|0.64|
74071728|NCT03587207|147695365|OTHER|96217 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.87|||||TWO_SIDED|80.0|0.69|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.09|0.69|
74071729|NCT03587207|147695365|OTHER|NZ98/254 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometrical mean ratio|0.87|||||TWO_SIDED|80.0|0.68|1.12|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.12|0.68|
73883742|NCT01247324|147300859|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.536|||<|0.0001|TWO_SIDED|95.0|0.4|0.719|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||0.719|0.4|<0.0001
73883743|NCT01247324|147300860|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||=|0.0139|TWO_SIDED|95.0|0.37|0.9|||Log Rank|||Time to onset CDP at week 12||0.90|0.37|= 0.0139
73883744|NCT01247324|147300861|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.058|||<|0.0001||95.0|0.032|0.104|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.104|0.032|< 0.0001
73883745|NCT01247324|147300862|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.229|||<|0.0001||95.0|0.174|0.3|||Negative Binomial Model||Adjusted by baseline T2 lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.300|0.174|< 0.0001
73883746|NCT01247324|147300863|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.61|||=|0.0106|TWO_SIDED|95.0|1.11|2.33|||CMH Chi-Squared test (stratified)|CMH (Cochran-Mantel-Haenszel) Chi-Squared test Stratified by Geographical Region (US vs. Rest of World) and Baseline EDSS (\<4.0 vs. \>=4.0)||||2.33|1.11|= 0.0106
73883747|NCT01247324|147300864|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||=|0.0278|TWO_SIDED|95.0|0.34|0.95|||Log Rank|||Time to onset CDP at week 24||0.95|0.34|= 0.0278
73883748|NCT01247324|147300865|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.428|||<|0.0001||95.0|0.328|0.557|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.557|0.328|< 0.0001
73883749|NCT01247324|147300866|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.039|STANDARD_ERROR_OF_MEAN|0.039|=|0.3261|TWO_SIDED|95.0|-0.039|0.116|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.116|-0.039|= 0.3261
73883750|NCT01247324|147300867|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.168|STANDARD_ERROR_OF_MEAN|0.058|=|0.0042|TWO_SIDED|95.0|0.053|0.283|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 22.8%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.283|0.053|= 0.0042
73883751|NCT01247324|147300868|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.693|STANDARD_ERROR_OF_MEAN|0.564|=|0.2193|TWO_SIDED|95.0|-0.414|1.8|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||1.800|-0.414|= 0.2193
73883752|NCT01247324|147300869|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.74|||<|0.0001|TWO_SIDED|95.0|1.39|2.17|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (\<4.0 vs. \>=4.0).||||2.17|1.39|< 0.0001
73883753|NCT03270436|147300910|SUPERIORITY|||||||0.3599||||||The p-value above reflects results of between-arms analysis of change in mean weight from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3599
73883754|NCT03270436|147300910|SUPERIORITY|||||||0.3207||||||The p-value above reflects results of between-arms analysis of change in mean weight from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3207
74071730|NCT03587207|147695365|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometrical mean ratio|0.88|||||TWO_SIDED|80.0|0.7|1.1|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.10|0.70|
74071731|NCT03587207|147695365|OTHER|M14459 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.91|||||TWO_SIDED|80.0|0.71|1.15|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp)strain, one month after first vaccination.||1.15|0.71|
74071732|NCT03587207|147695365|OTHER|96217 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.58|||||TWO_SIDED|80.0|0.47|0.73|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||0.73|0.47|
74071733|NCT03587207|147695365|OTHER|NZ98/254 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.69|||||TWO_SIDED|80.0|0.54|0.89|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||0.89|0.54|
74071734|NCT03587207|147695365|OTHER|M07-0241084 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.82|||||TWO_SIDED|80.0|0.65|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.03|0.65|
74071735|NCT00966953|147695373|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
74071736|NCT01734772|147695387|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|149.38|STANDARD_DEVIATION|37.6||0.9456||90.0|124.388|179.383||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||179.383|124.388|0.9456
74071737|NCT01734772|147695387|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|126.47|STANDARD_DEVIATION|33.3||0.5481||90.0|107.363|148.967||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||148.967|107.363|0.5481
74071738|NCT01734772|147695387|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|127.01|STANDARD_DEVIATION|31.6||0.5665||90.0|108.047|149.295||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||149.295|108.047|0.5665
74071739|NCT01734772|147695388|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|164.74|STANDARD_DEVIATION|42.9||0.9841||90.0|133.945|202.619||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||202.619|133.945|0.9841
74071740|NCT01734772|147695388|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|128.61|STANDARD_DEVIATION|39.0||0.6003||90.0|106.37|155.495||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||155.495|106.370|0.6003
74071741|NCT01734772|147695388|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|gMean Ratio|123.82|STANDARD_DEVIATION|36.9||0.4656||90.0|102.695|149.288||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||149.288|102.695|0.4656
74071742|NCT01600495|147695393|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||||||0.01
74071743|NCT01600495|147695394|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.25
74071744|NCT01600495|147695396|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Fisher Exact|||Fisher's exact test||||<0.01
74071745|NCT04947579|147695440|SUPERIORITY||Stratified difference|2.4||||0.829|TWO_SIDED|95.0|-18.2|22.7|||Cochran-Mantel-Haenszel||CC99677 60 mg - Placebo|||22.7|-18.2|0.829
74071746|NCT04947579|147695440|SUPERIORITY||Stratified difference|7.3||||0.512|TWO_SIDED|95.0|-13.8|27.5|||Cochran-Mantel-Haenszel||CC99677 150 mg - Placebo|||27.5|-13.8|0.512
74071747|NCT04947579|147695441|SUPERIORITY||Stratified difference|3.3||||0.725|TWO_SIDED|95.0|-14.9|21.0|||Cochran-Mantel-Haenszel||CC99677 60 mg - Placebo|||21.0|-14.9|0.725
74071748|NCT04947579|147695441|SUPERIORITY||Stratfied difference|12.2||||0.219|TWO_SIDED|95.0|-7.2|30.5|||Cochran-Mantel-Haenszel||CC99677 150 mg - Placebo|||30.5|-7.2|0.219
73883755|NCT03270436|147300911|SUPERIORITY|||||||0.5698||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.5698
73883756|NCT03270436|147300911|SUPERIORITY|||||||0.4106||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4106
73883757|NCT03270436|147300912|SUPERIORITY|||||||0.0293||||||The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.0293
74071749|NCT04947579|147695442|SUPERIORITY||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.167||0.299|TWO_SIDED|95.0|-0.5|0.16|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.16|-0.50|0.299
73883758|NCT03270436|147300912|SUPERIORITY|||||||0.4686||||||The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4686
73883759|NCT03270436|147300913|SUPERIORITY|||||||0.0068||||||The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.0068
73883760|NCT03270436|147300913|SUPERIORITY|||||||0.9181||||||The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.9181
73883761|NCT03270436|147300914|SUPERIORITY|||||||0.5984||||||The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.5984
73883762|NCT03270436|147300914|SUPERIORITY|||||||0.3376||||||The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3376
73888512|NCT05465317|147309652|OTHER||Hazard Ratio (HR)|0.81||||0.007|TWO_SIDED|95.0|0.7|0.94|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.94|0.70|0.007
73883763|NCT03270436|147300915|SUPERIORITY|||||||0.296||||||The p-value above reflects results of between-arms analysis of mean change in fruit \& vegetable consumption scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.2960
74071750|NCT04947579|147695442|SUPERIORITY||Difference in Adjusted Means|-0.12|STANDARD_ERROR_OF_MEAN|0.168||0.488|TWO_SIDED|95.0|-0.45|0.22|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||0.22|-0.45|0.488
74071751|NCT04947579|147695443|SUPERIORITY||Difference in Adjusted Means|0.01|STANDARD_ERROR_OF_MEAN|0.391||0.97|TWO_SIDED|95.0|-0.76|0.79|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.79|-0.76|0.970
74071752|NCT04947579|147695443|SUPERIORITY||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.393||0.668|TWO_SIDED|95.0|-0.95|0.61|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||0.61|-0.95|0.668
74071753|NCT04947579|147695444|SUPERIORITY||Difference in Adjusted Means|0.06|STANDARD_ERROR_OF_MEAN|0.416||0.89|TWO_SIDED|95.0|-0.77|0.88|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.88|-0.77|0.890
74071754|NCT04947579|147695444|SUPERIORITY||Difference in Adjusted Means|0.25|STANDARD_ERROR_OF_MEAN|0.417||0.545|TWO_SIDED|95.0|-0.57|1.08|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.08|-0.57|0.545
74071755|NCT04947579|147695445|SUPERIORITY||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.999||0.778|TWO_SIDED|95.0|-2.26|1.7|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||1.70|-2.26|0.778
74071756|NCT04947579|147695445|SUPERIORITY||Difference in Adjusted Means|-1.0|STANDARD_ERROR_OF_MEAN|1.022||0.33|TWO_SIDED|95.0|-3.02|1.03|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.03|-3.02|0.330
74071757|NCT04947579|147695446|SUPERIORITY||Difference in Adjusted Means|-0.82|STANDARD_ERROR_OF_MEAN|1.567||0.6|TWO_SIDED|95.0|-3.93|2.28|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||2.28|-3.93|0.600
74071758|NCT04947579|147695446|SUPERIORITY||Difference in Adjusted Means|-1.31|STANDARD_ERROR_OF_MEAN|1.605||0.416|TWO_SIDED|95.0|-4.49|1.87|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.87|-4.49|0.416
74071759|NCT04947579|147695447|SUPERIORITY||Adjusted Mean|-6.26|STANDARD_ERROR_OF_MEAN|10.741||||95.0|-27.31|14.79||||||||14.79|-27.31|
74071760|NCT04947579|147695447|SUPERIORITY||Adjusted Mean|-18.58|STANDARD_ERROR_OF_MEAN|9.181|||TWO_SIDED|95.0|-36.57|-0.58||||||||-0.58|-36.57|
74071761|NCT04947579|147695447|SUPERIORITY||Adjusted Mean|-12.16|STANDARD_ERROR_OF_MEAN|10.105|||TWO_SIDED|95.0|-31.96|7.65||||||||7.65|-31.96|
74071762|NCT03309956|147695456|SUPERIORITY|||||||0.23|||||||McNemar|||||||0.23
74071763|NCT01566409|147695459|NON_INFERIORITY_OR_EQUIVALENCE|The required sample size was based on a projected treatment success in the PEG group of 60%. With a power in excess of 80% and a critical level of significance of 0.05, 45 children were needed in each group to detect a 50% reduction in treatment effect in the placebo group, corresponding to 30% recovers without active maintenance treatment. Because of an expected drop-out rate of 25%, we aimed at including 115 children.||||||0.024|||||||Regression, Logistic|||||||0.024
74071764|NCT02768298|147695471|SUPERIORITY||Least Squares (LS) Mean|0.32|STANDARD_ERROR_OF_MEAN|0.268||0.2327|TWO_SIDED|95.0|-0.21|0.85|||ANCOVA|||||0.85|-0.21|0.2327
74071765|NCT02768298|147695472|SUPERIORITY||LS Mean|-0.14|STANDARD_ERROR_OF_MEAN|0.277||0.6247|TWO_SIDED|95.0|-0.68|0.41|||ANCOVA|||||0.41|-0.68|0.6247
74071766|NCT02768298|147695473|SUPERIORITY||LS Mean|-1.23|STANDARD_ERROR_OF_MEAN|0.888||0.1678|TWO_SIDED|95.0|-2.98|0.52|||ANCOVA|||6 weeks||0.52|-2.98|0.1678
74071767|NCT02768298|147695473|SUPERIORITY||LS Mean|0.83|STANDARD_ERROR_OF_MEAN|0.809||0.3052|TWO_SIDED|95.0|-0.77|2.43|||ANCOVA|||3 months||2.43|-0.77|0.3052
74071768|NCT02768298|147695474|SUPERIORITY||LS Mean|0.87|STANDARD_ERROR_OF_MEAN|1.744||0.6181|TWO_SIDED|95.0|-2.58|4.32|||ANCOVA|||6 weeks||4.32|-2.58|0.6181
74071769|NCT02768298|147695474|SUPERIORITY||LS Mean|3.28|STANDARD_ERROR_OF_MEAN|2.124||0.1254|TWO_SIDED|95.0|-0.93|7.48|||ANCOVA|||3 months||7.48|-0.93|0.1254
73883764|NCT03270436|147300915|SUPERIORITY|||||||0.1519||||||The p-value above reflects results of between-arms analysis of mean change in fruit \& vegetable consumption scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1519
73883765|NCT03270436|147300916|SUPERIORITY|||||||0.2824||||||The p-value above reflects results of between-arms analysis of change from baseline to immediate post-intervention. Analyses do not include imputed values.|Mantel Haenszel|The model includes only the study arm and time interaction.||Adjusted repeated measures generalized estimating equations (GEE) model.||||0.2824
74071770|NCT02768298|147695475|SUPERIORITY||LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.317||0.3432|TWO_SIDED|95.0|-0.93|0.33|||ANCOVA|||Borg value dyspnea||0.33|-0.93|0.3432
74071771|NCT02768298|147695475|SUPERIORITY||LS Mean|0.16|STANDARD_ERROR_OF_MEAN|0.251||0.5319|TWO_SIDED|95.0|-0.34|0.65|||ANCOVA|||Borg value fatigue||0.65|-0.34|0.5319
74071772|NCT04634409|147695476|SUPERIORITY||Odds Ratio (OR)|0.37||||0.009273|TWO_SIDED|95.0|0.18|0.78|||Regression, Logistic|||||0.78|0.18|0.009273
74071773|NCT04634409|147695476|SUPERIORITY||Odds Ratio (OR)|0.32||||0.000271|TWO_SIDED|95.0|0.18|0.59|||Regression, Logistic|||||0.59|0.18|0.000271
74071774|NCT04634409|147695476|SUPERIORITY||Odds Ratio (OR)|0.23||||0.000257|TWO_SIDED|95.0|0.1|0.51|||Regression, Logistic|||||0.51|0.10|0.000257
74071775|NCT04634409|147695476|SUPERIORITY||Odds Ratio (OR)|0.44||||0.013378|TWO_SIDED|95.0|0.23|0.84|||Regression, Logistic|||||0.84|0.23|0.013378
74071776|NCT04634409|147695476|SUPERIORITY||Odds Ratio (OR)|0.24||||0.000318|TWO_SIDED|95.0|0.11|0.52|||Regression, Logistic|||||0.52|0.11|0.000318
74071777|NCT04634409|147695476|SUPERIORITY||Odds Ratio (OR)|0.35||||0.140563|TWO_SIDED|95.0|0.09|1.41|||Regression, Logistic|||||1.41|0.09|0.140563
74071778|NCT04634409|147695477|SUPERIORITY||Odds Ratio (OR)|0.27||||0.000835|TWO_SIDED|95.0|0.12|0.58|||Regression, Logistic|||||0.58|0.12|0.000835
74071779|NCT04634409|147695478|SUPERIORITY||Odds Ratio (OR)|0.56||||0.097231|TWO_SIDED|95.0|0.28|1.11|||Regression, Logistic|||||1.11|0.28|0.097231
73883766|NCT03270436|147300916|SUPERIORITY|||||||0.7547||||||The p-value above reflects results of between-arms analysis of change from baseline to 6 months post-intervention. Analyses do not include imputed values.|Mantel Haenszel|The model includes only the study arm and time interaction.||Adjusted repeated measures generalized estimating equations (GEE) model.||||0.7547
74071780|NCT04634409|147695478|SUPERIORITY||Odds Ratio (OR)|0.59||||0.13236|TWO_SIDED|95.0|0.3|1.17|||Regression, Logistic|||||1.17|0.30|0.132360
73883767|NCT03270436|147300917|SUPERIORITY|||||||0.6928||||||The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.6928
73883768|NCT03270436|147300917|SUPERIORITY|||||||0.4947||||||The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4947
73883769|NCT03270436|147300918|SUPERIORITY|||||||0.1539||||||The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1539
74071781|NCT04634409|147695484|SUPERIORITY||Odds Ratio (OR)|0.62||||0.769|TWO_SIDED|95.0|0.02|15.57|||Regression, Logistic|||||15.57|0.02|0.769
74071782|NCT04634409|147695484|SUPERIORITY||Odds Ratio (OR)|0.32||||0.494|TWO_SIDED|95.0|0.01|8.12|||Regression, Logistic|||||8.12|0.01|0.494
74071783|NCT04634409|147695484|SUPERIORITY||Odds Ratio (OR)|0.5||||0.671|TWO_SIDED|95.0|0.02|12.51|||Regression, Logistic|||||12.51|0.02|0.671
74071784|NCT04634409|147695484|SUPERIORITY||Odds Ratio (OR)|0.49||||0.663|TWO_SIDED|95.0|0.02|12.27|||Regression, Logistic|||||12.27|0.02|0.663
74071785|NCT04634409|147695484|SUPERIORITY||Odds Ratio (OR)|0.51||||0.68|TWO_SIDED|95.0|0.02|12.76|||Regression, Logistic|||||12.76|0.02|0.680
74071786|NCT04634409|147695484|SUPERIORITY||Odds Ratio (OR)|2.51||||0.584|TWO_SIDED|95.0|0.09|67.88|||Regression, Logistic|||||67.88|0.09|0.584
74071787|NCT04634409|147695486|SUPERIORITY||Odds Ratio (OR)|1.02||||0.979|TWO_SIDED|95.0|0.17|6.06|||Regression, Logistic|||||6.06|0.17|0.979
74071788|NCT04634409|147695486|SUPERIORITY||Odds Ratio (OR)|1.42||||0.675|TWO_SIDED|95.0|0.27|7.39|||Regression, Logistic|||||7.39|0.27|0.675
74071789|NCT04634409|147695489|SUPERIORITY||LSM Difference|-0.67||||0.009|TWO_SIDED|95.0|-1.17|-0.17|||Mixed Models Analysis|||||-0.17|-1.17|0.009
74071790|NCT04634409|147695489|SUPERIORITY||LSM Difference|-0.65||||0.002|TWO_SIDED|95.0|-1.06|-0.24|||Mixed Models Analysis|||||-0.24|-1.06|0.002
74071791|NCT04634409|147695489|SUPERIORITY||LSM Difference|-0.26||||0.263|TWO_SIDED|95.0|-0.72|0.2|||Mixed Models Analysis|||||0.20|-0.72|0.263
73883770|NCT03270436|147300918|SUPERIORITY|||||||0.1878||||||The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1878
73883771|NCT03270436|147300919|SUPERIORITY|||||||0.4322||||||The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4322
74071792|NCT04634409|147695489|SUPERIORITY||LSM Difference|-0.41||||0.083|TWO_SIDED|95.0|-0.87|0.05|||Mixed Models Analysis|||||0.05|-0.87|0.083
74071793|NCT04634409|147695489|SUPERIORITY||LSM Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.35|-0.4|||Mixed Models Analysis|||||-0.40|-1.35|<0.001
74071794|NCT04634409|147695489|SUPERIORITY||LSM Difference|-0.64||||0.149|TWO_SIDED|95.0|-1.52|0.23|||Mixed Models Analysis|||||0.23|-1.52|0.149
74071795|NCT04634409|147695490|SUPERIORITY||LSM Difference|-0.82||||0.002|TWO_SIDED|95.0|-1.33|-0.31|||Mixed Models Analysis|||||-0.31|-1.33|0.002
74071796|NCT04634409|147695491|SUPERIORITY||LSM Difference|-0.14||||0.606|TWO_SIDED|95.0|-0.7|0.41|||Mixed Models Analysis|||||0.41|-0.70|0.606
74071797|NCT04634409|147695491|SUPERIORITY||LSM Difference|-0.38||||0.17|TWO_SIDED|95.0|-0.93|0.17|||Mixed Models Analysis|||||0.17|-0.93|0.170
74071798|NCT04634409|147695497|SUPERIORITY||Odds Ratio (OR)|0.96||||0.89|TWO_SIDED|95.0|0.53|1.73|||Regression, Logistic|||||1.73|0.53|0.890
74071799|NCT04634409|147695497|SUPERIORITY||Odds Ratio (OR)|1.43||||0.141|TWO_SIDED|95.0|0.89|2.29|||Regression, Logistic|||||2.29|0.89|0.141
74071800|NCT04634409|147695497|SUPERIORITY||Odds Ratio (OR)|1.15||||0.603|TWO_SIDED|95.0|0.67|1.98|||Regression, Logistic|||||1.98|0.67|0.603
74071801|NCT04634409|147695497|SUPERIORITY||Odds Ratio (OR)|1.69||||0.048|TWO_SIDED|95.0|1.0|2.84|||Regression, Logistic|||||2.84|1.00|0.048
74071802|NCT04634409|147695497|SUPERIORITY||Odds Ratio (OR)|1.19||||0.533|TWO_SIDED|95.0|0.69|2.04|||Regression, Logistic|||||2.04|0.69|0.533
74071803|NCT04634409|147695497|SUPERIORITY||Odds Ratio (OR)|1.09||||0.869|TWO_SIDED|95.0|0.4|2.99|||Regression, Logistic|||||2.99|0.40|0.869
74071804|NCT04634409|147695498|SUPERIORITY||Odds Ratio (OR)|1.31||||0.374|TWO_SIDED|95.0|0.72|2.35|||Regression, Logistic|||||2.35|0.72|0.374
74071805|NCT04634409|147695499|SUPERIORITY||Odds Ratio (OR)|1.87||||0.015|TWO_SIDED|95.0|1.13|3.08|||Regression, Logistic|||||3.08|1.13|0.015
74071806|NCT04634409|147695499|SUPERIORITY||Odds Ratio (OR)|1.29||||0.317|TWO_SIDED|95.0|0.78|2.11|||Regression, Logistic|||||2.11|0.78|0.317
74071807|NCT04634409|147695502|SUPERIORITY||Odds Ratio (OR)|1.62||||0.082|TWO_SIDED|95.0|0.94|2.81|||Regression, Logistic|||||2.81|0.94|0.082
74071808|NCT04634409|147695502|SUPERIORITY||Odds Ratio (OR)|1.86||||0.018|TWO_SIDED|95.0|1.11|3.11|||Regression, Logistic|||||3.11|1.11|0.018
74071809|NCT04634409|147695502|SUPERIORITY||Odds Ratio (OR)|1.71||||0.021|TWO_SIDED|95.0|1.09|2.71|||Regression, Logistic|||||2.71|1.09|0.021
74071810|NCT04634409|147695502|SUPERIORITY||Odds Ratio (OR)|1.93||||0.011|TWO_SIDED|95.0|1.16|3.22|||Regression, Logistic|||||3.22|1.16|0.011
74071811|NCT04634409|147695502|SUPERIORITY||Odds Ratio (OR)|2.17||||0.003|TWO_SIDED|95.0|1.3|3.6|||Regression, Logistic|||||3.60|1.30|0.003
74071812|NCT04634409|147695502|SUPERIORITY||Odds Ratio (OR)|1.34||||0.546|TWO_SIDED|95.0|0.52|3.48|||Regression, Logistic|||||3.48|0.52|0.546
74071813|NCT04634409|147695503|SUPERIORITY||Odds Ratio (OR)|1.04||||0.888|TWO_SIDED|95.0|0.6|1.82|||Regression, Logistic|||||1.82|0.60|0.888
74071814|NCT04634409|147695504|SUPERIORITY||Odds Ratio (OR)|1.88||||0.014|TWO_SIDED|95.0|1.13|3.13|||Regression, Logistic|||||3.13|1.13|0.014
74071815|NCT04634409|147695504|SUPERIORITY||Odds Ratio (OR)|1.63||||0.057|TWO_SIDED|95.0|0.98|2.71|||Regression, Logistic|||||2.71|0.98|0.057
74071816|NCT03708211|147695530|OTHER||Ratio of geometric mean|0.9359|||||TWO_SIDED|90.0|0.8084|1.0835||||||Following log-transformation, PK parameters were analyzed by analysis of variance (ANOVA) fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90 percent (%) confidence intervals (CIs) for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.0835|0.8084|
74071817|NCT03708211|147695531|OTHER||Ratio of geometric mean|1.0036|||||TWO_SIDED|90.0|0.8992|1.1201||||||Following log-transformation, PK parameters were analyzed by ANOVA fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90% CIs for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.1201|0.8992|
74071818|NCT03708211|147695532|OTHER||Ratio of geometric mean|1.0071|||||TWO_SIDED|90.0|0.9033|1.1227||||||Following log-transformation, PK parameters were analyzed by ANOVA fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90% CIs for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.1227|0.9033|
74071819|NCT01508936|147695561|SUPERIORITY_OR_OTHER||slope difference|0.3007|STANDARD_ERROR_OF_MEAN|0.2559||0.2407|TWO_SIDED|||||The interaction was tested at the significance level 0.10 using the FAS|Regression, Linear||Active - Placebo|The primary analysis was the linear regression model with model effects including treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count. A significant treatment by baseline eosinophil interaction would indicate that treatment difference varies by the baseline eosinophil count.||||0.2407
73883772|NCT03270436|147300919|SUPERIORITY|||||||0.9529||||||The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.9529
73883773|NCT00836589|147300943|NON_INFERIORITY|"Estimated SAEFR at 5 years is 92.5% with a 5% non-inferiority margin (87.5%).~Type I error (alpha) is 0.05 (one-sided for non-inferiority).~Statistical power is 80%."||||||0.002|||||||Binomial Proportion|||||||0.0020
73883774|NCT01890343|147300959|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||The effect of diagnostic group on mean cortical florbetapir binding relative to cerebellar cortex was determined.||||0.002
73883775|NCT04529083|147300989|OTHER||Mean Difference (Net)|-0.625||||0.011|TWO_SIDED|95.0|-1.06|-0.19|||t-test, 2 sided|||||-0.19|-1.06|0.011
74071820|NCT01508936|147695562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.0417||0.0697|TWO_SIDED|95.0|-0.006|0.158||Statistical significance level is 0.05.|Regression, Linear|treatment, blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as fixed effects.|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~* Lung function as measured by FEV1~* ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."||0.158|-0.006|0.0697
74071821|NCT01508936|147695563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.123|STANDARD_ERROR_OF_MEAN|0.0762||0.1072|TWO_SIDED|95.0|-0.273|0.027||significance level of 0.05|t-test, 2 sided|Fixed effects for treatment, hx of asthma exacerbation, sex, visit, and interaction of treatment and visit; covariates for height and baseline value|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~* Lung function as measured by FEV1~* ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."||0.027|-0.273|0.1072
74071822|NCT04603937|147695595|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin|Adjusted mean difference|-4.7|STANDARD_ERROR_OF_MEAN|0.97|>|0.9999|TWO_SIDED|95.04|-6.65|-2.81|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA and OCT CST.||||-2.81|-6.65|> 0.9999
73883776|NCT04529083|147300991|SUPERIORITY||Mean Difference (Net)|1.94||||0.006|TWO_SIDED|95.0|0.63|3.26|||t-test, 2 sided|||||3.26|0.63|0.006
73883777|NCT03186209|147301057|SUPERIORITY||Rate Ratio|0.26|||<|0.0001|TWO_SIDED|95.0|0.19|0.36||Multiplicity protected by hierarchy testing procedure. First in line hypothesis testing, requiring p-value \<0.05.|Negative binomial|Model with covariates: treatment group, region (China/Non-China), number of exacerbations in previous year, use of maintenance oral corticosteroids||||0.36|0.19|<0.0001
74071823|NCT04603937|147695596|NON_INFERIORITY|The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%|Difference of weighted percentages|0.6|||<|0.0001|TWO_SIDED|95.04|-0.7|2.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by study identifier and randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||2|-0.7|<0.0001
74071824|NCT04603937|147695597|NON_INFERIORITY|The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e the non-inferiority margin is 10%|Difference of weighted percentages|1.2|||<|0.0001|TWO_SIDED|95.04|-1.4|3.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||3.9|-1.4|<0.0001
74071825|NCT02518685|147695601|SUPERIORITY||Least-Square Mean Difference|6.7|||<|0.0001|TWO_SIDED|95.0|4.54|8.81|||multiple imputations|||||8.81|4.54|<0.0001
74071826|NCT02518685|147695602|SUPERIORITY|Statistical success criterion for achieving the performance standard of (≥ 50%) of proportion of TPS subjects who have 5% or more TBL at the 12-Month Follow-up|Proportion of Subjects|66.8|||<|0.0001|TWO_SIDED|95.0|59.3|74.3|||Wilson's Midpoint Estimate|||||74.3|59.3|<0.0001
74071827|NCT01611090|147695619|SUPERIORITY||Hazard Ratio (HR)|0.229|||<|0.0001|TWO_SIDED|95.0|0.183|0.286|||Log Rank|||||0.286|0.183|< 0.0001
74071828|NCT02683187|147695643|EQUIVALENCE|Insulin secretion, determined by insulin or C-peptide values in the 10 minutes after arginine infusion will be compared as a repeated measure for each subject in a 2 x 2 analysis of sitagliptin/placebo and Exendin-9/saline.|Median Difference (Final Values)|371.0|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
74071829|NCT00770315|147695644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.2192|TWO_SIDED|95.0|-1.98|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.45|-1.98|0.2192
74071830|NCT00770315|147695644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58||||0.0113|TWO_SIDED|95.0|-2.8|-0.36|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.36|-2.80|0.0113
74071831|NCT00770315|147695644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04||||0.0015|TWO_SIDED|95.0|-3.3|-0.79|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.79|-3.30|0.0015
74071832|NCT00770315|147695645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.0878|TWO_SIDED|95.0|-1.88|0.13|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.13|-1.88|0.0878
74071833|NCT00770315|147695645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0125|TWO_SIDED|95.0|-2.29|-0.28|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.28|-2.29|0.0125
74071834|NCT00770315|147695645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.92||||0.0003|TWO_SIDED|95.0|-2.95|-0.88|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.88|-2.95|0.0003
74071835|NCT00770315|147695646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.4781|TWO_SIDED|95.0|-0.96|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.45|-0.96|0.4781
74071836|NCT00770315|147695646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.1695|TWO_SIDED|95.0|-1.21|0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.21|-1.21|0.1695
74071837|NCT00770315|147695646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0118|TWO_SIDED|95.0|-1.67|-0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.21|-1.67|0.0118
74071838|NCT00770315|147695647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.2622|TWO_SIDED|95.0|-0.93|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.25|-0.93|0.2622
74071839|NCT00770315|147695647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1914|TWO_SIDED|95.0|-0.99|0.2|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.20|-0.99|0.1914
74071840|NCT00770315|147695647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0021|TWO_SIDED|95.0|-1.57|-0.35|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.35|-1.57|0.0021
74071841|NCT00770315|147695648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.19|TWO_SIDED|95.0|-1.26|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.25|-1.26|0.1900
74071842|NCT00770315|147695648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0053|TWO_SIDED|95.0|-1.84|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.84|0.0053
74071843|NCT00770315|147695648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.0058|TWO_SIDED|95.0|-1.89|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.89|0.0058
74071844|NCT02585258|147695649|SUPERIORITY||mean difference over 2-years|-0.37|||<|0.0001|ONE_SIDED|95.0||-0.23||one-sided.|Mixed Models Analysis||placebo is reference. Negative difference is beneficial, means lower disease activity in prednisolone group.|mixed model reports the effect of treatment, adjusted for stratification factors||-0.23||<0.0001
74071845|NCT02585258|147695650|SUPERIORITY||Risk Ratio (RR)|1.24||||0.02|ONE_SIDED|95.0|1.04|||one-sided|GEE||prednisolone/placebo|mixed model reports the effect of treatment, adjusted for stratification factors|||1.04|0.02
74071846|NCT02585258|147695651|SUPERIORITY||mean differences over 2 years|-1.67||||0.003|ONE_SIDED|95.0||-0.68||one-sided|Regression, Linear||placebo is reference. Negative difference means less damage progression in prednisolone group.|mixed model reports the effect of treatment, adjusted for stratification factors||-0.68||0.003
74071847|NCT01210001|147695658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|97.5|-0.69|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.27|-0.69|<0.0001
74071848|NCT01210001|147695658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|97.5|-0.82|-0.4||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.40|-0.82|<0.0001
74071849|NCT01210001|147695659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.48|STANDARD_ERROR_OF_MEAN|3.71|<|0.0001|TWO_SIDED|97.5|-31.81|-15.15||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo|||-15.15|-31.81|<0.0001
74071850|NCT01210001|147695659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.46|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|97.5|-36.73|-20.19||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo|||-20.19|-36.73|<0.0001
74071851|NCT01210001|147695660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|97.5|-2.64|-1.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo|||-1.27|-2.64|<0.0001
74071852|NCT01210001|147695660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|97.5|-2.49|-1.13||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 25mg minus placebo|||-1.13|-2.49|<0.0001
74071853|NCT01210001|147695661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.69|-0.21||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.21|-0.69|<0.0001
74071854|NCT01210001|147695661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.83|-0.36||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.36|-0.83|<0.0001
74071855|NCT02122796|147695664|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
73883778|NCT03186209|147301058|SUPERIORITY||Mean Difference (Final Values)|0.25|||<|0.0001|TWO_SIDED|95.0|0.17|0.34||Test after significant primary endpoint. Two secondary endpoints (change in FEV1 and total asthma symptom score) using Holm's procedure; smaller p-value to be \<0.025, and larger p-value to be \<0.05.|Mixed Models Analysis|Model includes Treatment, baseline pre-bronchodilator FEV1, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.34|0.17|<0.0001
73883779|NCT03186209|147301059|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.0126|TWO_SIDED|95.0|-0.45|-0.05||Test after significant primary endpoint. Two secondary endpoints (change in FEV1 and total asthma symptom score) using Holm's procedure; smaller p-value to be \<0.025, and larger p-value to be \<0.05.|Mixed Models Analysis|Model includes Treatment, baseline total asthma symptom score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-0.05|-0.45|0.0126
73883780|NCT03186209|147301060|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.1835|TWO_SIDED|95.0|-0.42|0.08||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline total asthma rescue medication use, region, use of maintenance oral corticosteroids, visit, treatment\*visit||||0.08|-0.42|0.1835
73883781|NCT03186209|147301061|SUPERIORITY||Mean Difference (Final Values)|38.66|||<|0.0001|TWO_SIDED|95.0|24.24|53.07||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline morning PEF, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||53.07|24.24|<0.0001
74071856|NCT02122796|147695665|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
74071857|NCT02122796|147695667|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
74071858|NCT00067236|147695683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.4239|TWO_SIDED|95.0|||||ANOVA|||Changes from baseline in efficacy parameters at Day 90.||||0.4239
74071859|NCT00721409|147695713|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.488||||0.0004|TWO_SIDED|95.0|0.319|0.748||1-sided p-value from the log-rank test stratified by stratification factors per randomization and Part.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Stratified analysis was presented above.||0.748|0.319|0.0004
74071860|NCT00721409|147695713|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.299|||<|0.0001|TWO_SIDED|95.0|0.156|0.572||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.||0.572|0.156|<0.0001
74071861|NCT00721409|147695713|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.508||||0.0046|TWO_SIDED|95.0|0.303|0.853||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.||0.853|0.303|0.0046
74071862|NCT00721409|147695726|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.897||||0.2812|TWO_SIDED|95.0|0.623|1.294||1-sided p-value from the log-rank test stratified by Part (α = 0.10).|Log Rank|||Stratified analysis was presented above. Hazard ratio was assuming proportional hazards, a hazard ratio less than 1 indicated a reduction in hazard rate in favor of palbociclib + letrozole.||1.294|0.623|0.2812
74071863|NCT00721409|147695726|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.837||||0.2803|TWO_SIDED|95.0|0.458|1.527||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.||1.527|0.458|0.2803
73883782|NCT03186209|147301062|SUPERIORITY||Mean Difference (Final Values)|35.85|||<|0.0001|TWO_SIDED|95.0|21.52|50.18||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline evening PEF, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||50.18|21.52|<0.0001
74071864|NCT00721409|147695726|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.935||||0.3875|TWO_SIDED|95.0|0.59|1.48||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.||1.480|0.590|0.3875
74071865|NCT00721409|147695727|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||0.1347|TWO_SIDED|95.0|0.76|2.97||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||2.97|0.76|0.1347
74071866|NCT00721409|147695727|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37||||0.0849|TWO_SIDED|95.0|0.74|7.84||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||7.84|0.74|0.0849
74071867|NCT00721409|147695727|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.4515|TWO_SIDED|95.0|0.48|2.76||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||2.76|0.48|0.4515
74071868|NCT00721409|147695728|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.93||||0.0471|TWO_SIDED|95.0|0.91|4.08||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||4.08|0.91|0.0471
74071869|NCT00721409|147695728|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.34||||0.118|TWO_SIDED|95.0|0.65|8.66||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||8.66|0.65|0.1180
74071870|NCT00721409|147695728|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.1631|TWO_SIDED|95.0|0.65|4.54||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||4.54|0.65|0.1631
74071871|NCT00721409|147695730|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.18||||0.0009|TWO_SIDED|95.0|1.48|6.98||1-sided p-value is from the stratified exact test (1-sided, α =0.10).|Cochran-Mantel-Haenszel|||CBR CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||6.98|1.48|0.0009
74071872|NCT00721409|147695730|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.18||||0.0065|TWO_SIDED|95.0|1.3|13.9||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||13.90|1.30|0.0065
74071873|NCT00721409|147695730|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55||||0.0442|TWO_SIDED|95.0|0.89|7.7||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||7.70|0.89|0.0442
74071874|NCT00721409|147695731|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.399|||<|0.0001|TWO_SIDED|95.0|0.265|0.601||1-sided p-value is from the stratified log-rank test (α =0.10).|Log Rank|||Kaplan-Meier method was applied for median and 95% CI. Hazard ratio was based on assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of palbociclib + letrozole.||0.601|0.265|<0.0001
74071875|NCT00721409|147695731|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.299|||<|0.0001|TWO_SIDED|95.0|0.156|0.572||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.||0.572|0.156|<0.0001
74071876|NCT00721409|147695731|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.486||||0.003|TWO_SIDED|95.0|0.288|0.822||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.||0.822|0.288|0.0030
74071877|NCT00721409|147695732|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.69|TWO_SIDED|95.0|-0.7|1.0||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.0|-0.7|0.6900
74071878|NCT00721409|147695732|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.7125|TWO_SIDED|95.0|-1.8|1.2||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.2|-1.8|0.7125
74071879|NCT00721409|147695732|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.4012|TWO_SIDED|95.0|-0.6|1.5||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.5|-0.6|0.4012
74071880|NCT00721409|147695733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3346|TWO_SIDED|95.0|-0.5|1.3||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.||1.3|-0.5|0.3346
74071881|NCT00721409|147695733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.563|TWO_SIDED|95.0|-1.0|1.9||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.||1.9|-1.0|0.5630
74071882|NCT00721409|147695733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.4427|TWO_SIDED|95.0|-0.7|1.6||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.6|-0.7|0.4427
74071883|NCT00818883|147695798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-8.3|-2.9||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.9|-8.3|<0.001
74071884|NCT00818883|147695798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|||<|0.001||95.0|-7.5|-2.5||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-2.5|-7.5|<0.001
74071885|NCT00818883|147695799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||<|0.001|TWO_SIDED|95.0|-5.2|-2.2||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.2|-5.2|<0.001
74071886|NCT00818883|147695799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED|95.0|-4.1|-1.3||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.3|-4.1|<0.001
74071887|NCT00818883|147695800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3|||<|0.001|TWO_SIDED|95.0|-10.5|-4.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-4.2|-10.5|<0.001
74071888|NCT00818883|147695800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.001|TWO_SIDED|95.0|-6.8|-1.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.7|-6.8|0.001
73883783|NCT03186209|147301063|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.3385|TWO_SIDED|95.0|-0.03|0.01||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline proportion of nights awakening, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.01|-0.03|0.3385
74071889|NCT00818883|147695801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|||<|0.001|TWO_SIDED|95.0|-6.3|-2.3||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.3|-6.3|<0.001
74071890|NCT00818883|147695801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.006|TWO_SIDED|95.0|-4.2|-0.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-0.7|-4.2|0.006
74071891|NCT00818883|147695802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|||<|0.001|TWO_SIDED|95.0|-8.4|-3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-3.2|-8.4|<0.001
74071892|NCT00818883|147695802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-6.4|-2.0||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-2.0|-6.4|<0.001
74071893|NCT00818883|147695803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-5.5|-2.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.1|-5.5|<0.001
73883784|NCT03186209|147301064|SUPERIORITY||Mean Difference (Final Values)|-0.43|||<|0.0001|TWO_SIDED|95.0|-0.58|-0.28||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline ACQ-6 score, use of maintenance oral corticosteroids, visit, and treatment by visit||||-0.28|-0.58|<0.0001
74071894|NCT00818883|147695803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-4.1|-1.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.1|-4.1|<0.001
74071895|NCT01193608|147695886|SUPERIORITY_OR_OTHER||Mean change|113.53||||0.599|TWO_SIDED|80.0|-170.3|397.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||397.35|-170.30|0.599
74071896|NCT01193608|147695888|SUPERIORITY_OR_OTHER||Mean change|48.85||||0.297|TWO_SIDED|80.0|-11.79|109.48|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||109.48|-11.79|0.297
74071897|NCT01193608|147695890|SUPERIORITY_OR_OTHER||Mean change|-15.26||||0.6|TWO_SIDED|80.0|-53.54|23.02|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||23.02|-53.54|0.600
74071898|NCT01193608|147695892|SUPERIORITY_OR_OTHER||Mean change|1.23||||0.603|TWO_SIDED|80.0|-1.89|4.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||4.35|-1.89|0.603
74071899|NCT03552757|147695978|SUPERIORITY||Treatment difference|-6.21|||<|0.0001|TWO_SIDED|95.0|-7.28|-5.15|||ANCOVA|||Results are based on the data from in-trial observation period. Week 68 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment, stratification groups (oral anti-diabetic (OAD) treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.||-5.15|-7.28|<0.0001
74071900|NCT03552757|147695978|SUPERIORITY||Treatment difference|-7.57|||<|0.0001|TWO_SIDED|95.0|-8.56|-6.58|||MMRM|||Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements (MMRM) with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.||-6.58|-8.56|<0.0001
74071901|NCT03552757|147695979|SUPERIORITY||Odds Ratio (OR)|4.88|||<|0.0001|TWO_SIDED|95.0|3.58|6.64|||Regression, Logistic|||Results are based on the data from in-trial observation period. Week 68 responses were analysed using a binary logistic regression model with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.||6.64|3.58|<0.0001
74071902|NCT03552757|147695979|SUPERIORITY||Odds Ratio (OR)|8.69|||<|0.0001|TWO_SIDED|95.0|6.31|11.97|||Regression, Logistic|||Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a MMRM with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.||11.97|6.31|<0.0001
74071903|NCT00449150|147696019|SUPERIORITY_OR_OTHER||LS means estimate|-0.198||||0.7424|TWO_SIDED|95.0|-1.38|0.98|||ANOVA|||||0.98|-1.38|0.7424
74071904|NCT00449150|147696019|SUPERIORITY_OR_OTHER||LS means estimate|0.055||||0.926||95.0|-1.1|1.21|||ANOVA|||||1.21|-1.10|0.926
74071905|NCT00449150|147696019|SUPERIORITY_OR_OTHER||LS means estimate|-0.252||||0.6699||95.0|-1.41|0.91|||ANOVA|||||0.91|-1.41|0.6699
74071906|NCT02674334|147696022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|STANDARD_ERROR_OF_MEAN|0.83||0.165|TWO_SIDED|95.0|-0.49|2.82||P-values were not adjusted for multiple inferences|ANOVA|Continuous responses were tested using RCB ANOVA.||||2.82|-.49|0.165
73883785|NCT03186209|147301065|SUPERIORITY||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.23|0.43||Nominal p-value. Not multiplicity protected by testing procedure.|Regression, Cox|model including covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.43|0.23|<0.0001
74071907|NCT00982553|147696030|SUPERIORITY||Geometric mean ratios|0.79|||||TWO_SIDED|95.0|0.62|1.0||||||||1.00|0.62|
74071908|NCT00982553|147696031|SUPERIORITY||Geometric mean ratios|1.16|||||TWO_SIDED|95.0|0.73|1.86||||||||1.86|0.73|
74071909|NCT00982553|147696032|SUPERIORITY||Geometric mean ratios|1.01|||||TWO_SIDED|95.0|0.87|1.18||||||||1.18|0.87|
74071910|NCT00982553|147696033|SUPERIORITY||Geometric mean ratios|0.82|||||TWO_SIDED|95.0|0.36|1.85||||||||1.85|0.36|
74071911|NCT01345019|147696037|NON_INFERIORITY|A two-stage approach was used for the non-inferiority test. First, the fixed margin approach was used to ensure denosumab has an effect greater than placebo (ie, the non-inferiority margin M1, ie, the lower bound of the two-sided 95% confidence interval 1.28, is ruled out). Next, a synthesis method was used for the non-inferiority test of the hypothesis that denosumab preserved at least 50% of the effect of zoledronic acid (HR \[95% CI\] of 1.48 \[1.28, 1.71\] for placebo vs zoledronic acid.|Hazard Ratio (HR)|0.98||||0.01|TWO_SIDED|95.0|0.85|1.14|||Cox proportional hazards model|Based on a Cox proportional hazards model stratified by the randomization stratification factors.|A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab|||1.14|0.85|0.010
74071912|NCT01345019|147696040|SUPERIORITY|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.||||||0.82|||||||Log Rank|Based on a log rank test stratified by randomization stratification factors.||||||0.82
74071913|NCT01345019|147696041|SUPERIORITY|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.|Rate ratio|1.01||||0.84|TWO_SIDED|95.0|0.89|1.15|||Andersen-Gill model|Based on an Andersen-Gill model stratified by the randomization stratification factors.|A rate ratio (denosumab:zoledronic acid) \< 1 favors denosumab.|||1.15|0.89|0.84
74071914|NCT01345019|147696043|SUPERIORITY|If superiority of denosumab over zoledronic acid was established for both time to first SRE and time to first and subsequent SRE, the additional secondary endpoint (overall survival) was to be tested at a significance level of 0.05.|Hazard Ratio (HR)|0.9||||0.41|TWO_SIDED|95.0|0.7|1.16|||Cox proportional hazards model||A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab.|The survival function of time to death for each treatment group was estimated using Kaplan-Meier method and the hazard ratio of denosumab compared with zoledronic acid and its 2-sided 95% CI were estimated using a Cox proportional hazards model stratified by the randomization stratification factors and including treatment groups, age, race group, geographic region, baseline creatinine clearance, baseline risk per cytogenetic based prognosis, and baseline ECOG as independent variables.||1.16|0.70|0.41
74071915|NCT00235456|147696045|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.61||||0.04|TWO_SIDED|95.0|0.38|0.98|||Chi-squared|||||0.98|0.38|0.04
74071916|NCT00235456|147696046|SUPERIORITY_OR_OTHER|||||||0.54|||||||t-test, 2 sided|||||||0.54
73883786|NCT03186209|147301066|SUPERIORITY||Odds Ratio (OR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.19|0.42||Nominal p-value. Not multiplicity protected by testing procedure.|Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year (2, \>=3), use of OCS||||0.42|0.19|<0.0001
74071917|NCT00235456|147696047|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
74071918|NCT00235456|147696048|SUPERIORITY_OR_OTHER|||||||0.57|||||||t-test, 2 sided|||||||0.57
73883787|NCT03186209|147301067|SUPERIORITY||Mean Difference (Final Values)|-9.19|||<|0.0001|TWO_SIDED|95.0|-12.79|-5.6||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model with covariates: treatment group, baseline SGRQ total score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-5.60|-12.79|<0.0001
74071919|NCT00235456|147696049|SUPERIORITY_OR_OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
74071920|NCT00235456|147696050|SUPERIORITY_OR_OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
74071921|NCT04087395|147696051|NON_INFERIORITY|To achieve non-inferiority, the observed p-value must be \<= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).|||||<|0.0001||||||One-sided paired student t-test|t-test, 1 sided|||||||<0.0001
74071922|NCT02796664|147696064|OTHER|Equality test||||||0.462|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and cerebral ischemic events including ischemic stroke and transient ischemic attack. The number of participants who suffered ischemic stroke and the number of paticipants who suffered transient ischemic attack were analyzed together to test the null hypothesis in two by two table.||||0.462
74071923|NCT02796664|147696065|OTHER|Equality test||||||0.34|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and modified Rankin Scale at follow-up.||||0.34
74071924|NCT02796664|147696066|OTHER|Equality test||||||0.13|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and flow change in steno-occlusive lesion.||||0.13
74071925|NCT02796664|147696066|OTHER|Equality test||||||0.17|||||||Chi-squared|||The null hypothesis is that there is no relationship between ginseng administration and flow change in collateral vessel.||||0.17
74071926|NCT02796664|147696067|OTHER|Equality test||||||0.74|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and periventricular white matter lesions at follow-up.||||0.74
74071927|NCT02796664|147696067|OTHER|Equality test||||||0.95|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and deep white matter lesions at follow-up.||||0.95
74071928|NCT02796664|147696068|OTHER|Equality test||||||0.23|||||||Chi-squared|||The null hypothesis is that there is no relationship between ginseng administration and parenchymal ischemic lesions at follow-up.||||0.23
74071929|NCT02796664|147696069|OTHER|Equality test||||||0.79|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no relationship between ginseng administration and drug compliance at follow-up.||||0.79
74071930|NCT00995553|147696087|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||ANOVA|||MATRICS Working Memory Index||||.06
74071931|NCT00995553|147696087|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||ANOVA|||MATRICS Attention Index||||.09
74071932|NCT00995553|147696088|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANOVA|||||||.73
74071933|NCT01089647|147696089|OTHER||||||=|0.946|||||||ANOVA|||Between-group comparisons at follow-up were made using a stepwise multivariable logistic model.||||=0.946
74071934|NCT01807637|147696096|SUPERIORITY||Mean Difference (Final Values)|9.1|STANDARD_ERROR_OF_MEAN|5.37||0.05|TWO_SIDED||||||Mixed Models Analysis|||||||.05
74071935|NCT01807637|147696097|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_DEVIATION|1.12||0.05|TWO_SIDED||||||ANOVA|||||||.05
74071936|NCT01807637|147696098|SUPERIORITY||Mean Difference (Final Values)|15.67|STANDARD_DEVIATION|3.41||0.05|TWO_SIDED||||||ANOVA|||||||.05
74071937|NCT00950807|147696099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|||<|0.001|TWO_SIDED|95.0|0.06|0.196|||Mixed Models Analysis|||||0.196|0.060|<0.001
74071938|NCT00950807|147696099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|||<|0.001|TWO_SIDED|95.0|0.077|0.216|||Mixed Models Analysis|||||0.216|0.077|<0.001
74071939|NCT00950807|147696099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095||||0.006|TWO_SIDED|95.0|0.027|0.162|||Mixed Models Analysis|||||0.162|0.027|0.006
74071940|NCT00950807|147696099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.074|0.205|||Mixed Models Analysis|||||0.205|0.074|<0.001
74071941|NCT00950807|147696099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||<|0.001|TWO_SIDED|95.0|0.113|0.259|||Mixed Models Analysis|||||0.259|0.113|<0.001
74071942|NCT00950807|147696099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.03|TWO_SIDED|95.0|0.008|0.151|||Mixed Models Analysis|||||0.151|0.008|0.030
74071943|NCT00950807|147696099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||<|0.001|TWO_SIDED|95.0|0.064|0.204|||Mixed Models Analysis|||||0.204|0.064|<0.001
74071944|NCT00950807|147696099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.101|0.242|||Mixed Models Analysis|||||0.242|0.101|<0.001
74071945|NCT00950807|147696099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.003|TWO_SIDED|95.0|0.037|0.173|||Mixed Models Analysis|||||0.173|0.037|0.003
74071946|NCT02933866|147696120|SUPERIORITY|||||||0.2961|||||||Cochran-Mantel-Haenszel|||||||0.2961
74071947|NCT04646109|147696133|SUPERIORITY|||||||0.43||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.43
74071948|NCT04646109|147696134|SUPERIORITY|||||||0.14||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.14
74071949|NCT04646109|147696135|SUPERIORITY|||||||0.68||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.68
74071950|NCT04646109|147696136|SUPERIORITY|||||||0.15||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.15
74071951|NCT04646109|147696137|SUPERIORITY|||||||0.37||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.37
74071952|NCT04646109|147696138|SUPERIORITY|||||||0.12||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.12
74071953|NCT04646109|147696139|SUPERIORITY|||||||0.22||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.22
74071954|NCT04646109|147696142|SUPERIORITY|||||||0.1||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.10
74071955|NCT04646109|147696143|SUPERIORITY|||||||0.37||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.37
74071956|NCT04646109|147696144|SUPERIORITY|||||||0.03||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.03
74071957|NCT04646109|147696145|SUPERIORITY|||||||0.39||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.39
74071958|NCT04646109|147696146|SUPERIORITY|||||||0.24||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.24
74071959|NCT04646109|147696147|SUPERIORITY|||||||0.56||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.56
74071960|NCT04646109|147696148|SUPERIORITY|||||||0.005||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.005
74071961|NCT04646109|147696149|SUPERIORITY|||||||0.03||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.03
74071962|NCT04646109|147696150|SUPERIORITY|||||||0.01||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.01
74071963|NCT02841709|147696198|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose response across placebo and all ACT-541468 doses. The null hypothesis of no dose response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"||||<0.001
74071964|NCT02841709|147696198|OTHER||LS mean difference|-5.4|STANDARD_ERROR_OF_MEAN|4.73||0.258|TWO_SIDED|95.0|-14.7|4.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean|||4.0|-14.7|0.258
74071965|NCT02841709|147696198|OTHER||LS mean difference|-18.4|STANDARD_ERROR_OF_MEAN|4.76|<|0.001|TWO_SIDED|95.0|-27.8|-9.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean|||-9.0|-27.8|<0.001
74071966|NCT02841709|147696198|OTHER||LS mean difference|-31.5|STANDARD_ERROR_OF_MEAN|4.74|<|0.001|TWO_SIDED|95.0|-40.9|-22.2|||Linear mixed effects model|||||-22.2|-40.9|<0.001
74071967|NCT02841709|147696198|OTHER||LS mean difference|-47.8|STANDARD_ERROR_OF_MEAN|4.74|<|0.001|TWO_SIDED|95.0|-57.2|-38.5|||Linear mixed effects model|||||-38.5|-57.2|<0.001
74071968|NCT00076102|147696207|OTHER|||||||0.0301||||||The reported F statistic and p-value are representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Adaptive Behavior.|ANOVA|||F=5.45 under the null hypothesis||||0.0301
74071969|NCT00076102|147696207|OTHER|||||||0.0186||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Emotional Functioning.|ANOVA|||F = 6.56 under the null hypothesis||||0.0186
74071970|NCT00076102|147696207|OTHER|||||||0.0032||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Medical/Physical Status.|ANOVA|||F=11.23 under the null hypothesis||||0.0032
74071971|NCT00076102|147696208|OTHER|||||||0.6263|||||||ANOVA|||F=0.25 under the null hypothesis||||0.6263
74071972|NCT00076102|147696208|OTHER|||||||0.3625|||||||ANOVA|||F= 0.87 under the null hypothesis||||0.3625
74071973|NCT00076102|147696208|OTHER|||||||0.5877|||||||ANOVA|||F=0.31 under the null hypothesis||||0.5877
74071974|NCT00076102|147696208|OTHER|||||||0.2767|||||||ANOVA|||F=1.27 under the null hypothesis||||0.2767
74071975|NCT00076102|147696208|OTHER|||||||0.8466|||||||ANOVA|||F=0.04 under the null hypothesis||||0.8466
74071976|NCT00076102|147696208|OTHER|||||||0.6774|||||||ANOVA|||F=0.18 under the null hypothesis||||0.6774
74071977|NCT01739790|147696222|OTHER|||||||0.45|||||||Fisher Exact|||||||0.45
74071978|NCT02581345|147696223|EQUIVALENCE|Per Food and Drug Administration (FDA), the equivalence testing was made using 90% confidence interval and an equivalence margin of 18%|Difference in proportion (M923 - EU RPP)|0.014|||||TWO_SIDED|90.0|-0.043|0.072||||||||0.072|-0.043|
74071979|NCT02581345|147696223|EQUIVALENCE|Per European Medicines Agency (EMA), the equivalence testing was made using 95% confidence interval and an equivalence margin of 15%|Difference in proportion (M923 - EU RPP)|0.014|||||TWO_SIDED|95.0|-0.054|0.082||||||||0.082|-0.054|
74071980|NCT02581345|147696224|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale was calculated using stratified Newcombe method.|Difference in proportion (M923 - EU RPP)|0.031|||||TWO_SIDED|95.0|-0.048|0.11||||||||0.110|-0.048|
74071981|NCT02581345|147696225|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.18;+0.18\] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||TWO_SIDED|90.0|-0.061|0.016||||||||0.016|-0.061|
74071982|NCT02581345|147696225|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.15;+0.15\] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||TWO_SIDED|95.0|-0.069|0.024||||||||0.024|-0.069|
74071983|NCT02581345|147696228|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.18;+0.18\] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||TWO_SIDED|90.0|0.01|0.149||||||||0.149|0.010|
74071984|NCT02581345|147696228|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are:\[-0.15;+0.15\] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||TWO_SIDED|95.0|-0.004|0.162||||||||0.162|-0.004|
74071985|NCT01124149|147696323|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.61|||<|0.001|TWO_SIDED|95.0|1.76|3.87|||Regression, Logistic|||||3.87|1.76|<0.001
74071986|NCT01124149|147696324|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.44|3.07|||Regression, Logistic|||||3.07|1.44|<0.001
74071987|NCT00977106|147696331|SUPERIORITY_OR_OTHER|||||||0.472|||||||Chi-squared|||||||0.472
74071988|NCT00977106|147696332|SUPERIORITY_OR_OTHER|||||||0.377||||||Between-group test (equal variances)|Student t-test|||Change at Week 1||||0.377
74071989|NCT00977106|147696332|SUPERIORITY_OR_OTHER|||||||0.276|||||||Student t-test|Between-group test (unequal variances)||Change at Week 4||||0.276
74071990|NCT00977106|147696334|SUPERIORITY_OR_OTHER|||||||0.502|||||||Student t-test|Between-group test (equal variances)||Change at Week 4||||0.502
74071991|NCT00977106|147696336|SUPERIORITY_OR_OTHER|||||||0.434||||||Between placebo and TCZ groups test (Equal Variances) at week 4|t-test, 1 sided|||||||0.434
74071992|NCT00977106|147696338|SUPERIORITY_OR_OTHER|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1||||0.692
74071993|NCT00977106|147696338|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4||||0.019
74071994|NCT00977106|147696339|SUPERIORITY_OR_OTHER|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1||||0.137
74071995|NCT00977106|147696339|SUPERIORITY_OR_OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4||||0.043
74071996|NCT01644500|147696383|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.76|-0.39|||Mixed Models Analysis|||||-0.39|-0.76|<0.001
74071997|NCT01644500|147696383|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13|||Mixed Models Analysis|||||-0.13|-0.50|<0.001
74071998|NCT01644500|147696384|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|5.0|1.8|4.1||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact|||||4.1|1.8|<0.001
74071999|NCT01644500|147696384|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.0|2.3||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact|||||2.3|1.0|<0.001
74072000|NCT01644500|147696384|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9|||<|0.001|TWO_SIDED|95.0|1.8|4.5||Treatment comparison for HbA1c \<7.0%.|Fisher Exact|||||4.5|1.8|<0.001
74072001|NCT01644500|147696384|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.192|TWO_SIDED|95.0|1.1|2.5||Treatment comparison for HbA1c \<7.0%.|Fisher Exact|||||2.5|1.1|0.192
74072002|NCT01644500|147696385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.15|-0.51|||Mixed Models Analysis|||||-0.51|-1.15|<0.001
74072003|NCT01644500|147696385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.38||||0.022|TWO_SIDED|95.0|-0.7|-0.05|||Mixed Models Analysis|||||-0.05|-0.70|0.022
74072004|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.67|||<|0.001|TWO_SIDED|95.0|-0.89|-0.45||Treatment comparison for morning (fasting).|Mixed Models Analysis|||||-0.45|-0.89|<0.001
74072005|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.304|TWO_SIDED|95.0|-0.34|0.11||Treatment comparison for morning (fasting).|Mixed Models Analysis|||||0.11|-0.34|0.304
74072006|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.36|||<|0.001|TWO_SIDED|95.0|-1.8|-0.92||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.92|-1.80|<0.001
74072007|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.55||||0.015|TWO_SIDED|95.0|-0.99|-0.11||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.11|-0.99|0.015
74072008|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.1|-0.36||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis|||||-0.36|-1.10|<0.001
74072009|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06||||0.74|TWO_SIDED|95.0|-0.43|0.31||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis|||||0.31|-0.43|0.740
74072010|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.56|||<|0.001|TWO_SIDED|95.0|-1.99|-1.13||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis|||||-1.13|-1.99|<0.001
74072011|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-1.24|-0.39||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.39|-1.24|<0.001
74072012|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.67|||<|0.001|TWO_SIDED|95.0|-1.0|-0.34||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis|||||-0.34|-1.00|<0.001
74072013|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.08||||0.638|TWO_SIDED|95.0|-0.41|0.25||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis|||||0.25|-0.41|0.638
74072014|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.68|-0.87||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.87|-1.68|<0.001
74072015|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.03|TWO_SIDED|95.0|-0.85|-0.04||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.04|-0.85|0.030
74072016|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.19|||<|0.001|TWO_SIDED|95.0|-1.56|-0.82||Treatment comparison for bedtime.|Mixed Models Analysis|||||-0.82|-1.56|<0.001
74072017|NCT01644500|147696386|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.66|||<|0.001|TWO_SIDED|95.0|-1.03|-0.29||Treatment comparison for bedtime.|Mixed Models Analysis|||||-0.29|-1.03|<0.001
74072018|NCT01644500|147696387|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model|||||||<0.001
74072019|NCT01644500|147696387|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model|||||||<0.001
74072020|NCT01644500|147696387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model|||||||0.008
74072021|NCT01644500|147696387|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model|||||||0.006
74072022|NCT01644500|147696388|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
74072023|NCT01644500|147696388|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
74072024|NCT01644500|147696389|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.41|||<|0.001|TWO_SIDED|95.0|11.27|23.55|||ANCOVA|||Insulin HOMA2-%B||23.55|11.27|<0.001
74072025|NCT01644500|147696389|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.92||||0.012|TWO_SIDED|95.0|1.78|14.06|||ANCOVA|||Insulin HOMA2%B||14.06|1.78|0.012
74072026|NCT01644500|147696389|SUPERIORITY||Mean Difference (Net)|16.44|||<|0.001|TWO_SIDED|95.0|11.81|21.06|||ANCOVA|||C-Peptide-Based HOMA2-%B||21.06|11.81|<0.001
74072027|NCT01644500|147696389|SUPERIORITY||Mean Difference (Net)|9.99|||<|0.001|TWO_SIDED|95.0|5.36|14.62|||ANCOVA|||C-Peptide-Based HOMA2-%B||14.62|5.36|<0.001
74072028|NCT01644500|147696390|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.34||||0.913|TWO_SIDED|95.0|-5.83|6.51|||ANCOVA|||Insulin-Based HOMA2%S||6.51|-5.83|0.913
74072029|NCT01644500|147696390|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.14||||0.318|TWO_SIDED|95.0|-9.3|3.03|||ANCOVA|||Insulin-Based HOMA2%S||3.03|-9.30|0.318
74072030|NCT01644500|147696390|SUPERIORITY||Mean Difference (Net)|-1.39||||0.576|TWO_SIDED|95.0|-6.27|3.49|||ANCOVA|||C-Peptide-Based HOMA2-%S||3.49|-6.27|0.576
74072031|NCT01644500|147696390|SUPERIORITY||Mean Difference (Net)|-6.79||||0.007|TWO_SIDED|95.0|-11.68|-1.89|||ANCOVA|||C-Peptide-Based HOMA2-%S||-1.89|-11.68|0.007
74072032|NCT01644500|147696393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||||||Treatment comparison for SBP.|Mixed Models Analysis|||||||0.180
74072033|NCT01644500|147696393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||||||Treatment comparison for SBP.|Mixed Models Analysis|||||||0.245
74072034|NCT01644500|147696393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.717||||||Treatment comparison for DBP.|Mixed Models Analysis|||||||0.717
74072035|NCT01644500|147696393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619||||||Treatment comparison for DBP.|Mixed Models Analysis|||||||0.619
74072036|NCT01644500|147696394|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74072037|NCT01644500|147696394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
74072038|NCT01644500|147696397|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74072039|NCT01644500|147696397|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74072040|NCT01644500|147696398|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74072041|NCT01644500|147696398|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74072042|NCT00442936|147696481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.4|3.66|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.66|1.40|<0.001
74072043|NCT00442936|147696481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81|||<|0.001|TWO_SIDED|95.0|2.42|6.0|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||6.00|2.42|<0.001
74072044|NCT00442936|147696482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82|||<|0.001|TWO_SIDED|95.0|2.02|3.95|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.95|2.02|<0.001
74072045|NCT00442936|147696482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.001|TWO_SIDED|95.0|2.47|4.79|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.79|2.47|<0.001
74072046|NCT00442936|147696483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.54|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.97|1.54|<0.001
74072047|NCT00442936|147696483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61|||<|0.001|TWO_SIDED|95.0|1.89|3.61|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.61|1.89|<0.001
74072048|NCT00442936|147696484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.001|TWO_SIDED|95.0|1.49|2.82|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.82|1.49|<0.001
74072049|NCT00442936|147696484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37|||<|0.001|TWO_SIDED|95.0|1.73|3.25|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.25|1.73|<0.001
74072050|NCT00442936|147696485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73|||<|0.001|TWO_SIDED|95.0|1.25|2.39|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.39|1.25|<0.001
74072051|NCT00442936|147696485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.006|TWO_SIDED|95.0|1.13|2.13|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.13|1.13|0.006
74072052|NCT00442936|147696486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8||||0.002|TWO_SIDED|95.0|1.47|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.35|1.47|0.002
74072053|NCT00442936|147696486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|3.15|10.51|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||10.51|3.15|<0.001
74072054|NCT00442936|147696487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.026|TWO_SIDED|95.0|1.07|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.97|1.07|0.026
74072055|NCT00442936|147696487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.08|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.35|2.08|<0.001
74072056|NCT00442936|147696488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.021|TWO_SIDED|95.0|1.13|4.47|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.47|1.13|0.021
74072057|NCT00442936|147696488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21|||<|0.001|TWO_SIDED|95.0|2.78|9.76|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||9.76|2.78|<0.001
74072058|NCT00048048|147696496|SUPERIORITY_OR_OTHER||Least square mean|0.979|STANDARD_ERROR_OF_MEAN|0.223|||TWO_SIDED|95.0|0.534|1.425|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ Week||1.425|0.534|
74072059|NCT00048048|147696496|SUPERIORITY_OR_OTHER||Least square mean|0.851|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.395|1.307|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ 2Week||1.307|0.395|
74072060|NCT00048048|147696496|SUPERIORITY_OR_OTHER||Least square mean|0.932|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|95.0|0.488|1.377|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X /3 Week||1.377|0.488|
74072061|NCT02684578|147696503|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects regression|||||||0.39
74072062|NCT02684578|147696504|SUPERIORITY|||||||0.97||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects|||||||0.97
74072063|NCT02684578|147696505|SUPERIORITY|||||||0.12||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects|||||||0.12
74072064|NCT04084483|147696551|SUPERIORITY|||||||0.2175|||||||ANCOVA|||||||0.2175
74072065|NCT04084483|147696552|SUPERIORITY|||||||0.3852|||||||ANCOVA|||||||0.3852
74072066|NCT04084483|147696553|SUPERIORITY|||||||0.298|||||||ANCOVA|||||||0.2980
74072067|NCT04084483|147696554|SUPERIORITY|||||||0.0634|||||||ANCOVA|||||||0.0634
74072068|NCT04084483|147696555|SUPERIORITY|||||||0.7388|||||||ANCOVA|||Corneal Sum||||0.7388
74072069|NCT04084483|147696555|SUPERIORITY|||||||0.3717|||||||ANCOVA|||Corneal Sum||||0.3717
74072070|NCT04084483|147696555|SUPERIORITY|||||||0.3164|||||||ANCOVA|||Conjunctival Sum||||0.3164
74072071|NCT04084483|147696555|SUPERIORITY|||||||0.1953|||||||ANCOVA|||Conjunctival Sum||||0.1953
74072072|NCT04084483|147696555|SUPERIORITY|||||||0.4645|||||||ANCOVA|||Total Eye Sum||||0.4645
74072073|NCT04084483|147696555|SUPERIORITY|||||||0.2135|||||||ANCOVA|||Total Eye Sum||||0.2135
74072074|NCT04084483|147696556|SUPERIORITY|||||||0.599|||||||ANCOVA|||||||0.5990
74072075|NCT04084483|147696556|SUPERIORITY|||||||0.2122|||||||ANCOVA|||||||0.2122
74072076|NCT04084483|147696557|SUPERIORITY|||||||0.9146|||||||ANCOVA|||||||0.9146
74072077|NCT04084483|147696557|SUPERIORITY|||||||0.8494|||||||ANCOVA|||||||0.8494
74072078|NCT04084483|147696558|SUPERIORITY|||||||0.4747|||||||ANCOVA|||||||0.4747
74072079|NCT04084483|147696558|SUPERIORITY|||||||0.5619|||||||ANCOVA|||||||0.5619
74072080|NCT04084483|147696559|SUPERIORITY|||||||0.5985|||||||ANCOVA|||||||0.5985
74072081|NCT04084483|147696559|SUPERIORITY|||||||0.7626|||||||ANCOVA|||||||0.7626
74072082|NCT04084483|147696560|SUPERIORITY|||||||0.833|||||||ANCOVA|||||||0.8330
74072083|NCT04084483|147696560|SUPERIORITY|||||||0.2777|||||||ANCOVA|||||||0.2777
74072084|NCT04084483|147696561|SUPERIORITY|||||||0.9829|||||||ANCOVA|||||||0.9829
74072085|NCT04084483|147696561|SUPERIORITY|||||||0.8675|||||||ANCOVA|||||||0.8675
74072086|NCT04084483|147696562|SUPERIORITY|||||||0.5836|||||||ANCOVA|||||||0.5836
74072087|NCT04084483|147696562|SUPERIORITY|||||||0.2352|||||||ANCOVA|||||||0.2352
74072088|NCT04084483|147696563|SUPERIORITY|||||||0.7367|||||||ANCOVA|||Ocular Discomfort||||0.7367
74072089|NCT04084483|147696563|SUPERIORITY|||||||0.3865|||||||ANCOVA|||Ocular Discomfort||||0.3865
74072090|NCT04084483|147696563|SUPERIORITY|||||||0.8796|||||||ANCOVA|||Burning||||0.8796
74072091|NCT04084483|147696563|SUPERIORITY|||||||0.3515|||||||ANCOVA|||Burning||||0.3515
74072092|NCT04084483|147696563|SUPERIORITY|||||||0.6338|||||||ANCOVA|||Dryness||||0.6338
74072093|NCT04084483|147696563|SUPERIORITY|||||||0.4685|||||||ANCOVA|||Dryness||||0.4685
74072094|NCT04084483|147696563|SUPERIORITY|||||||0.4757|||||||ANCOVA|||Grittiness||||0.4757
74072095|NCT04084483|147696563|SUPERIORITY|||||||0.8803|||||||ANCOVA|||Grittiness||||0.8803
74072096|NCT04084483|147696563|SUPERIORITY|||||||0.8529|||||||ANCOVA|||Stinging||||0.8529
74072097|NCT04084483|147696563|SUPERIORITY|||||||0.7713|||||||ANCOVA|||Stinging||||0.7713
74072098|NCT04084483|147696564|SUPERIORITY|||||||0.138|||||||ANCOVA|||Burning/Stinging||||0.1380
74072099|NCT04084483|147696564|SUPERIORITY|||||||0.3334|||||||ANCOVA|||Burning/Stinging||||0.3334
74072100|NCT04084483|147696564|SUPERIORITY|||||||0.1008|||||||ANCOVA|||Itching||||0.1008
74072101|NCT04084483|147696564|SUPERIORITY|||||||0.4582|||||||ANCOVA|||Itching||||0.4582
74072102|NCT04084483|147696564|SUPERIORITY|||||||0.1511|||||||ANCOVA|||Foreign Body Sensation||||0.1511
74072103|NCT04084483|147696564|SUPERIORITY|||||||0.2555|||||||ANCOVA|||Foreign Body Sensation||||0.2555
74072104|NCT04084483|147696564|SUPERIORITY|||||||0.1546|||||||ANCOVA|||Blurry Vision||||0.1546
74072105|NCT04084483|147696564|SUPERIORITY|||||||0.0495|||||||ANCOVA|||Blurry Vision||||0.0495
74072106|NCT04084483|147696564|SUPERIORITY|||||||0.5791|||||||ANCOVA|||Eye Dryness||||0.5791
74072107|NCT04084483|147696564|SUPERIORITY|||||||0.0736|||||||ANCOVA|||Eye Dryness||||0.0736
74072108|NCT04084483|147696564|SUPERIORITY|||||||0.3666|||||||ANCOVA|||Photophobia||||0.3666
74072109|NCT04084483|147696564|SUPERIORITY|||||||0.039|||||||ANCOVA|||Photophobia||||0.0390
74072110|NCT04084483|147696564|SUPERIORITY|||||||0.0655|||||||ANCOVA|||Pain||||0.0655
74072111|NCT04084483|147696564|SUPERIORITY|||||||0.1947|||||||ANCOVA|||Pain||||0.1947
74072112|NCT04084483|147696565|SUPERIORITY|||||||0.9274|||||||ANCOVA|||||||0.9274
74072113|NCT04084483|147696565|SUPERIORITY|||||||0.0888|||||||ANCOVA|||||||0.0888
74072114|NCT01458405|147696575|SUPERIORITY|||||||0.6453||||||Repeated measures multivariable linear regression with Baseline as a covariate and unstructured covariance.|Regression, Linear|||||||0.6453
74072115|NCT02194998|147696598|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR12 rate \<= 70%.||||<0.01
74072116|NCT02194998|147696598|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR12 rate \<= 70%.||||0.47
74072117|NCT02194998|147696598|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR12 rate \<= 70%.||||<0.01
74072118|NCT02194998|147696598|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR12 rate \<= 70%.||||0.24
74072119|NCT02194998|147696611|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR24 rate \<= 70%.||||<0.01
74072120|NCT02194998|147696611|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR24 rate \<= 70%.||||0.47
74072121|NCT02194998|147696611|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR24 rate \<= 70%.||||<0.01
74072122|NCT02194998|147696611|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR24 rate \<= 70%.||||0.24
74072123|NCT01890915|147696663|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||"Due to impaired thermoregulatory mechanisms secondary to spinal cord injury, subjects with tetraplegia were hypothesized to have a significant rise in core temperature after exposure to warm ambient temperatures, while control subjects were hypothesized to maintain constant core temperature.~Percent change in core temperature of subjects in each group were compared to determine if they were significantly different from baseline to warm exposure."||||0.0001
74072124|NCT01890915|147696664|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANOVA|||We hypothesized that subjects with tetraplegia would demonstrate a change in cognitive performance after heat exposure if they had demonstrated a significant increase in core body temperature - as was hypothesized in our primary hypothesis. Cognitive performance was measured, in part, by Interference T-scores derived from the Stroop Color and Word Test.||||0.006
74072125|NCT01890915|147696665|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||ANOVA|||Due to impaired thermoregulatory mechanisms, subjects with tetraplegia were hypothesized to have diminished increases in sweat rate in comparison to controls after heat exposure.||||0.015
74072126|NCT00386009|147696676|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.068
74072127|NCT00386009|147696677|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.626
74072128|NCT00386009|147696678|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.113
74072129|NCT00386009|147696679|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.837
74072130|NCT00386009|147696680|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.400
74072131|NCT00386009|147696681|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.864
74072132|NCT00386009|147696682|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.340
74072133|NCT00386009|147696683|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.838
74072134|NCT00386009|147696684|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.609
74072135|NCT00386009|147696685|SUPERIORITY_OR_OTHER|||||||0.427||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.427
74072136|NCT00386009|147696686|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.838
74072137|NCT00386009|147696687|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.090
74072138|NCT00386009|147696688|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.113
74072139|NCT00386009|147696691|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
74072140|NCT02465567|147696693|SUPERIORITY||Rate Ratio|0.76|||<|0.0001|TWO_SIDED|95.0|0.69|0.83|||Negative Binomial Regression|||||0.83|0.69|<0.0001
74072141|NCT02465567|147696693|SUPERIORITY||Rate Ratio|0.87||||0.0027|TWO_SIDED|95.0|0.79|0.95|||Negative Binomial Regression|||||0.95|0.79|0.0027
74072142|NCT02465567|147696693|SUPERIORITY||Rate Ratio|0.75|||<|0.0001|TWO_SIDED|95.0|0.69|0.83|||Negative Binomial Regression|||||0.83|0.69|<0.0001
74072143|NCT02465567|147696693|SUPERIORITY||Rate Ratio|0.86||||0.002|TWO_SIDED|95.0|0.79|0.95|||Negative Binomial Regression|||||0.95|0.79|0.0020
74072144|NCT02465567|147696694|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0035|TWO_SIDED|95.0|0.807|0.959|||Regression, Cox|||||0.959|0.807|0.0035
74072145|NCT02465567|147696694|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.057|TWO_SIDED|95.0|0.814|0.966|||Regression, Cox|||||0.966|0.814|0.057
74072146|NCT02465567|147696694|SUPERIORITY||Hazard Ratio (HR)|0.866||||0.0011|TWO_SIDED|95.0|0.794|0.944|||Regression, Cox|||||0.944|0.794|0.0011
74072147|NCT02465567|147696694|SUPERIORITY||Hazard Ratio (HR)|0.873||||0.0019|TWO_SIDED|95.0|0.801|0.951|||Regression, Cox|||||0.951|0.801|0.0019
74072148|NCT02465567|147696695|SUPERIORITY||Mean Difference (Final Values)|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.34|||Linear Repeated Measures|||||-0.34|-0.68|<0.0001
74072149|NCT02465567|147696695|SUPERIORITY||Mean Difference (Final Values)|-0.37|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.2|||Linear Repeated Measures|||||-0.20|-0.54|<0.0001
74072150|NCT02465567|147696695|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.0001|TWO_SIDED|95.0|-0.53|-0.18|||Linear Repeated Measures|||||-0.18|-0.53|<0.0001
74072151|NCT02465567|147696695|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.0127|TWO_SIDED|95.0|-0.39|-0.05|||Linear Repeated Measures|||||-0.05|-0.39|0.0127
74072152|NCT02465567|147696696|SUPERIORITY||Odds Ratio (OR)|1.358|||<|0.0001|TWO_SIDED|95.0|1.199|1.539|||Regression, Logistic|||||1.539|1.199|<0.0001
74072153|NCT02465567|147696696|SUPERIORITY||Odds Ratio (OR)|1.246||||0.0005|TWO_SIDED|95.0|1.1|1.41|||Regression, Logistic|||||1.410|1.100|0.0005
73883788|NCT03186209|147301068|SUPERIORITY||Rate ratio|0.46||||0.0222|TWO_SIDED|95.0|0.24|0.9||Nominal p-value. Not multiplicity protected by testing procedure.|Negative binomial|Model includes Treatment, use of maintenance oral corticosteroids, categorical variable of ER/UC or hospitalization exacerbations during previous year||||0.90|0.24|0.0222
74072154|NCT02465567|147696696|SUPERIORITY||Odds Ratio (OR)|1.283|||<|0.0004|TWO_SIDED|95.0|1.133|1.454|||Regression, Logistic|||||1.454|1.133|<0.0004
74072155|NCT02465567|147696696|SUPERIORITY||Odds Ratio (OR)|1.177||||0.0103|TWO_SIDED|95.0|1.039|1.333|||Regression, Logistic|||||1.333|1.039|0.0103
74072156|NCT02465567|147696697|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.0111|TWO_SIDED|95.0|0.34|0.87|||Regression, Cox|||||0.870|0.340|0.0111
74072157|NCT02465567|147696697|SUPERIORITY||Hazard Ratio (HR)|0.782||||0.3401|TWO_SIDED|95.0|0.472|1.296|||Regression, Cox|||||1.296|0.472|0.3401
74072158|NCT02465567|147696697|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.269|TWO_SIDED|95.0|0.518|1.201|||Regression, Cox|||||1.201|0.518|0.2690
73883789|NCT03186209|147301072|SUPERIORITY||Mean Difference (Final Values)|-119.31|||<|0.0001|TWO_SIDED|95.0|-169.78|-68.84||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|model includes treatment , baseline eosinophil count, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-68.84|-169.78|<0.0001
74072159|NCT02465567|147696697|SUPERIORITY||Hazard Ratio (HR)|1.134||||0.5918|TWO_SIDED|95.0|0.716|1.796|||Regression, Cox|||||1.796|0.716|0.5918
74072160|NCT02465567|147696698|SUPERIORITY||Rate Ratio|0.84||||0.6552|TWO_SIDED|95.0|0.69|1.03|||Negative Binomial Regression|||||1.03|0.69|0.6552
74072161|NCT02465567|147696698|SUPERIORITY||Rate Ratio|0.8||||0.0221|TWO_SIDED|95.0|0.66|0.97|||Negative Binomial Regression|||||0.97|0.66|0.0221
74072162|NCT02465567|147696698|SUPERIORITY||Rate Ratio|0.88||||0.2157|TWO_SIDED|95.0|0.72|1.08|||Negative Binomial Regression|||||1.08|0.72|0.2157
74072163|NCT02465567|147696698|SUPERIORITY||Rate Ratio|0.83||||0.0647|TWO_SIDED|95.0|0.69|1.01|||Negative Binomial Regression|||||1.01|0.69|0.0647
74072164|NCT00497796|147696699|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on the ICH guidance, the hypothesis of non-inferiority can be tested using a one-sided 97.5% confidence interval's (CI) upper bound comparing with the non-inferiority margin of 5% (0.05).|Rate difference|0.041|||||TWO_SIDED|95.0|-0.038|0.119|||||Rate difference is the rate of maribavir minus the rate of ganciclovir|||0.119|-0.038|
74072165|NCT00497796|147696699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.586||||0.2754|TWO_SIDED|95.0|0.682|3.69||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||||3.690|0.682|0.2754
74072166|NCT00497796|147696700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.793||||0.0283|TWO_SIDED|95.0|1.065|3.02||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of the pp65 antigenemia assay||3.020|1.065|0.0283
74072167|NCT00497796|147696700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.284||||0.0024|TWO_SIDED|95.0|1.338|3.9|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay||3.900|1.338|0.0024
74072168|NCT00497796|147696700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.177||||0.0053|TWO_SIDED|95.0|1.259|3.767||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay||3.767|1.259|0.0053
74072169|NCT00497796|147696700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.388||||0.2339|TWO_SIDED|95.0|0.811|2.377||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy||2.377|0.811|0.2339
74072170|NCT00497796|147696701|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Hazard Ratio|2.25|||<|0.0001|TWO_SIDED|95.0|1.62|3.14|||Log Rank||Maribavir versus ganciclovir; Cox's proportional hazards regression model: time = receipt of induction ALA and geographic region (US or Europe) + treatment.|Analysis of time to onset||3.14|1.62|<0.0001
73883790|NCT03186209|147301073|SUPERIORITY||Rate Ratio|0.83||||0.4519|TWO_SIDED|95.0|0.51|1.35||Nominal p-value. Not multiplicity protected by testing procedure.|Negative binomial|Model with covariates: treatment group, region (China/Non-China), number of exacerbations in previous year, use of maintenance oral corticosteroids||||1.35|0.51|0.4519
73883791|NCT03186209|147301074|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.0214|TWO_SIDED|95.0|0.02|0.22||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline pre-bronchodilator FEV1, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.22|0.02|0.0214
73883792|NCT03186209|147301075|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.1589|TWO_SIDED|95.0|-0.51|0.08||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline total asthma symptom score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.08|-0.51|0.1589
73883793|NCT03164668|147301076|SUPERIORITY||Estimated mean ratio|0.31|||||TWO_SIDED|95.0|0.13|0.72|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes|Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes||0.72|0.13|
73883794|NCT03164668|147301076|SUPERIORITY||Estimated mean ratio|0.98|||||TWO_SIDED|95.0|0.78|1.22|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes|Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes||1.22|0.78|
73883795|NCT03164668|147301077|SUPERIORITY||Estimated mean ratio|3.03|||||TWO_SIDED|95.0|1.39|6.61|||||Model estimated mean ratio in puffs of e-cigarettes used per day among those randomized to conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes|Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes||6.61|1.39|
73883796|NCT03164668|147301077|SUPERIORITY||Estimated mean ratio|0.74|||||TWO_SIDED|95.0|0.59|0.92|||||Estimated mean ratio of number of puffs of e-cigarettes used per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes|Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes||0.92|0.59|
73883797|NCT04739982|147301083|SUPERIORITY||Cohen's D|0.03|STANDARD_ERROR_OF_MEAN|1.36||0.41|TWO_SIDED|95.0|-0.21|0.27||An independent samples t-test was conducted to compare the change in baseline and follow-up scores of treatment and treatment as usual participants.|t-test, 1 sided|Degrees of freedom=274 Significance level=.05||||.27|-.21|.41
74072171|NCT00497796|147696702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant||||0.0008
74072172|NCT00497796|147696702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3742|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant||||0.3742
74072173|NCT00497796|147696703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||||||0.0007
73883798|NCT04739982|147301084|SUPERIORITY||Cohen's D|0.153|STANDARD_ERROR_OF_MEAN|1.45||0.095|TWO_SIDED|95.0|-0.08|0.39|||t-test, 1 sided|||||.39|-.08|.095
73883799|NCT04739982|147301086|SUPERIORITY||Cohen's D|0.19|STANDARD_ERROR_OF_MEAN|0.55||0.09|TWO_SIDED|95.0|-0.09|0.47|||t-test, 1 sided|||||.47|-.09|.09
73883800|NCT02960217|147301238|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|1.46||||0.2684|TWO_SIDED|95.0|-1.12|4.36||Hodges-Lehmann estimate of the location shift with 95% confidence interval (CI) and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Participants completing both UX007 treatment period and placebo period (n=42). Per protocol, when the normality assumption is not met (p value for Wilk-Shapiro test \< 0.05), Wilcoxon rank-sum test will be considered as the primary analysis to assess treatment difference in movement disorder event frequency.||4.36|-1.12|0.2684
73883801|NCT02960217|147301238|SUPERIORITY||||||<|0.0001|||||||Wilk-Shapiro test for normality|||||||< 0.0001
73883802|NCT02960217|147301241|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|25.0||||0.6419|TWO_SIDED|95.0|-62.5|91.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=34).||91.5|-62.5|0.6419
73883803|NCT02960217|147301241|SUPERIORITY|||||||0.0005|||||||Wilk-Shapiro Test for Normality|||||||0.0005
74072174|NCT00497796|147696704|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.041|||<|0.0001|TWO_SIDED|95.0|2.179|7.494||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia assay||7.494|2.179|<0.0001
74072175|NCT00497796|147696704|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.448|||<|0.0001|TWO_SIDED|95.0|3.404|12.213||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay||12.213|3.404|<0.0001
74072176|NCT00497796|147696704|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.02|||<|0.0001|TWO_SIDED|95.0|3.342|10.843||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay||10.843|3.342|<0.0001
74072177|NCT00497796|147696704|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.165|||<|0.0001|TWO_SIDED|95.0|4.146|30.069||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy||30.069|4.146|<0.0001
73883804|NCT02960217|147301242|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.91||0.9513|TWO_SIDED|95.0|-2.0|1.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||1.9|-2.0|0.9513
73883805|NCT02960217|147301242|SUPERIORITY|||||||0.8214|||||||Wilk-Shapiro Test for Normality|||||||0.8214
74072178|NCT00320112|147696724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.004|TWO_SIDED|||||no differences between arms in baseline characteristics at \<0.1 level, further analyses adjusted for variables that could influence the outcome like insulin use, age, commodities. because no differences in results, unadjusted analyses are reported.|Regression, Linear|we used STATA 11's xtmixed command, which fits multi-level mixed-effects linear regression models, with clustering by assigned pairs.||||||0.004
74072179|NCT00320112|147696725|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||this is a priori design|Regression, Linear|||||||.91
74072180|NCT00320112|147696726|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Regression, Linear|||||||0.10
74072181|NCT00320112|147696727|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
74072182|NCT02899338|147696728|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using the analysis of variance (ANOVA)|Adjusted geometric mean ratio|101.71|STANDARD_ERROR_OF_MEAN|42.28|||TWO_SIDED|90.0|91.31|113.29|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual geometric coefficient of variation (gCV)|Comparison AI versus PFS||113.29|91.31|
74072183|NCT02899338|147696729|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|100.11|STANDARD_ERROR_OF_MEAN|23.72|||TWO_SIDED|90.0|94.17|106.43|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS||106.43|94.17|
74072184|NCT02899338|147696730|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|103.19|STANDARD_ERROR_OF_MEAN|48.21|||TWO_SIDED|90.0|91.38|116.53|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS||116.53|91.38|
74072185|NCT00117949|147696746|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
73883806|NCT02960217|147301243|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.32||0.1572|TWO_SIDED|95.0|-0.8|4.7||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.7|-0.8|0.1572
74072186|NCT00117949|147696746|SUPERIORITY_OR_OTHER||Median days to insufficient T response|84.0||||||95.0|35.0|112.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response.||112|35|
74072187|NCT00117949|147696746|SUPERIORITY_OR_OTHER||Median days to insufficient T response|98.0||||||95.0|70.0|126.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response||126|70|
74072188|NCT00117949|147696746|SUPERIORITY_OR_OTHER||Median days to insufficient T response|35.0||||||95.0|14.0|98.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response||98|14|
74072189|NCT00117949|147696747|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|Participants not castrated were censored as of the days from dosing for the last available observation.||||||0.003
74072190|NCT00117949|147696747|SUPERIORITY_OR_OTHER||Median time to castration (days)|3.0||||||95.0|3.0|7.0||||||Kaplan-Meier estimates of the median time to testosterone castration.||7|3|
74072191|NCT00117949|147696747|SUPERIORITY_OR_OTHER||Median time to castration (days)|3.0||||||95.0|1.0|3.0||||||Kaplan-Meier estimates of the time to testosterone castration.||3|1|
74072192|NCT00117949|147696748|SUPERIORITY_OR_OTHER||Percentage of participants|0.0||||||95.0|0.0|0.0||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||0|0|
74072193|NCT00117949|147696748|SUPERIORITY_OR_OTHER||Percentage of participants|42.7||||||95.0|22.0|63.4||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||63.4|22|
74072194|NCT00117949|147696748|SUPERIORITY_OR_OTHER||Percentage of participants|61.6||||||95.0|41.8|81.3||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||81.3|41.8|
74072195|NCT00117949|147696748|SUPERIORITY_OR_OTHER||Percentage of participants|35.6||||||95.0|15.8|55.5||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||55.5|15.8|
74072196|NCT00117949|147696749|SUPERIORITY_OR_OTHER|||||||0.181||95.0|||||Cochran-Armitage Trend Test.|||||||0.181
74072197|NCT00117949|147696749|SUPERIORITY_OR_OTHER||Percentage of participants|10.0||||||95.0|0.3|44.5||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||44.5|0.3|
73883807|NCT02960217|147301243|SUPERIORITY|||||||0.8451|||||||Wilk-Shapiro Test for Normality|||||||0.8451
73883808|NCT02960217|147301244|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.66||0.8345|TWO_SIDED|95.0|-3.8|3.1||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||3.1|-3.8|0.8345
74072198|NCT00117949|147696749|SUPERIORITY_OR_OTHER||Percentage of participants|70.8||||||95.0|48.9|87.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||87.4|48.9|
74072199|NCT00117949|147696749|SUPERIORITY_OR_OTHER||Percentage of participants|79.2||||||95.0|57.8|92.9||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||92.9|57.8|
74072200|NCT00117949|147696749|SUPERIORITY_OR_OTHER||Percentage of participants|54.2||||||95.0|32.8|74.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||74.4|32.8|
74072201|NCT00117949|147696750|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Log Rank|||||||0.046
74072202|NCT00117949|147696750|SUPERIORITY_OR_OTHER||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||28|14|
74072203|NCT00117949|147696750|SUPERIORITY_OR_OTHER||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||28|14|
74072204|NCT00117949|147696750|SUPERIORITY_OR_OTHER||days|28.0||||||95.0|14.0|41.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||41|14|
74072205|NCT00117949|147696751|SUPERIORITY_OR_OTHER|||||||0.926||95.0|||||Log Rank|||||||0.926
74072206|NCT00117949|147696751|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|56.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||56|35|
74072207|NCT00117949|147696751|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|84.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||84|35|
73883809|NCT02960217|147301244|SUPERIORITY|||||||0.2894|||||||Wilk-Shapiro Test for Normality|||||||0.2894
73883810|NCT02960217|147301245|SUPERIORITY|||||||0.0005|||||||Wilk-Shapiro Test for Normality|||||||0.0005
74072208|NCT00117949|147696751|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|100.0|||||The upper confidence interval limit could not be calculated. For technical reasons it has been entered as 100.|Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||100|35|
74072209|NCT00159965|147696755|SUPERIORITY_OR_OTHER||Risk Ratio, log|0.673|STANDARD_ERROR_OF_MEAN|0.369||0.29|TWO_SIDED|95.0|-0.051|1.396|||Overdispersed Poisson Regression|||Between-group seizure change. The primary hypothesis of this pilot randomized control trial (RCT) was to assess the magnitude of seizure frequency reduction by treatment, comparing placbo to sertraline. The alternative hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.||1.396|-0.051|0.29
74072210|NCT00159965|147696755|SUPERIORITY_OR_OTHER||Risk Ratio, log|-0.598|STANDARD_ERROR_OF_MEAN|0.276||0.03|TWO_SIDED|95.0|-1.139|-0.073|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.||-0.073|-1.139|0.03
74072211|NCT00159965|147696755|SUPERIORITY_OR_OTHER||Risk Ratio, log|0.077|STANDARD_ERROR_OF_MEAN|0.252||0.78|TWO_SIDED|95.0|-0.431|0.571|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with placebo will not show a significant decrease in seizures from baseline to exit.||0.571|-0.431|0.78
74072212|NCT00159965|147696756|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072213|NCT00159965|147696757|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072214|NCT00159965|147696758|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072215|NCT00159965|147696759|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072216|NCT00159965|147696760|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072217|NCT00159965|147696761|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072218|NCT00159965|147696762|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072219|NCT00159965|147696763|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072220|NCT00159965|147696764|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072221|NCT00159965|147696765|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072222|NCT00159965|147696766|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
73883811|NCT02960217|147301245|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|0.2||||0.4898|TWO_SIDED|95.0|-5.4|5.8||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=21).||5.8|-5.4|0.4898
74072223|NCT00159965|147696767|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072224|NCT00159965|147696768|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
74072225|NCT01868009|147696783|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The response was analyzed and adjusted for study inhaler use sequence and preference question version. The method accounted for participants who indicated no preference.|Cochran-Mantel-Haenszel|||||||<0.001
74072226|NCT01244126|147696832|SUPERIORITY_OR_OTHER||Kruskall Wallis ANOVA by ranks|0.21|STANDARD_DEVIATION|3.0||0.21|TWO_SIDED|95.0|||||Kruskal-Wallis|||The primary outcome of the study was the maximum postoperative FLACC pain score.||||0.21
74072227|NCT01244126|147696833|SUPERIORITY_OR_OTHER||Kruskall Wallis ANOVA|0.34||||0.34||95.0|||||Kruskal-Wallis|||Kruskall Wallis test||||0.34
74072228|NCT00863746|147696835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9934||||0.4687|TWO_SIDED|95.0|0.8409|1.1735||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||1.1735|0.8409|0.4687
74072229|NCT00863746|147696836|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6068|||<|0.0001|TWO_SIDED|95.0|0.5139|0.7165||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||0.7165|0.5139|<0.0001
74072230|NCT00863746|147696837|SUPERIORITY_OR_OTHER||CMH-adjusted difference in proportions|0.2263|||<|1e-06|TWO_SIDED|95.0|0.1575|0.2952|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||||0.2952|0.1575|<0.000001
74072231|NCT00863746|147696838|SUPERIORITY_OR_OTHER||CMH-adjusted difference in proportions|0.039||||0.000876|TWO_SIDED|95.0|0.0137|0.0642|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||||0.0642|0.0137|0.000876
73883812|NCT02960217|147301246|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.42||0.5853|TWO_SIDED|95.0|-2.2|3.8||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||3.8|-2.2|0.5853
74072232|NCT00863746|147696839|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.542|||<|0.0001|TWO_SIDED|95.0|0.4526|0.6492||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||0.6492|0.4526|<0.0001
74072233|NCT00863746|147696840|SUPERIORITY_OR_OTHER|||||||0.3121||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis|||||||0.3121
73883813|NCT02960217|147301246|SUPERIORITY|||||||0.1066|||||||Wilk-Shapiro Test for Normality|||||||0.1066
74072234|NCT00863746|147696841|SUPERIORITY_OR_OTHER|||||||0.2948||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis|||||||0.2948
74072235|NCT00863746|147696842|SUPERIORITY_OR_OTHER|||||||0.8344||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis|||||||0.8344
74072236|NCT00863746|147696843|SUPERIORITY_OR_OTHER|||||||0.1438||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis|||||||0.1438
74072237|NCT00863746|147696844|SUPERIORITY_OR_OTHER|||||||0.9228||||||p-value for treatment effect equal to 0.|Mixed Models Analysis|||||||0.9228
74072238|NCT01545076|147696851|SUPERIORITY||Difference in Percent|-24.6|||=|0.007|TWO_SIDED|95.0|-40.7|-6.21|||Fisher Exact|||||-6.21|-40.7|=0.007
74072239|NCT01545076|147696851|SUPERIORITY||Difference in Percent|-30.4|||<|0.001|TWO_SIDED|95.0|-46.0|-12.2|||Fisher Exact|||||-12.2|-46.0|<0.001
73883814|NCT02960217|147301247|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.33||0.1875|TWO_SIDED|95.0|-4.6|1.0||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||1.0|-4.6|0.1875
74072240|NCT01545076|147696852|OTHER||Median Difference (Net)|0.0|||=|0.005|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum|||||0|-1|=0.005
74072241|NCT01545076|147696852|OTHER||Median Difference (Net)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum|||||0|-1|<0.001
74072242|NCT01545076|147696853|OTHER||Median Difference (Net)|7.6|||=|0.004|TWO_SIDED|95.0|2.0|14.0|||Wilcoxon rank sum|||||14|2|=0.004
74072243|NCT01545076|147696853|OTHER||Median Difference (Net)|5.7|||=|0.014|TWO_SIDED|95.0|0.7|11.7|||Wilcoxon rank sum|||||11.7|0.7|=0.014
74072244|NCT01545076|147696854|OTHER||Median Difference (Final Values)|2.0|||=|0.003|TWO_SIDED|95.0|1.0|4.0|||Wilcoxon rank sum|||||4|1|=0.003
74072245|NCT01545076|147696854|OTHER||Median Difference (Final Values)|2.0|||=|0.002|TWO_SIDED|95.0|1.0|4.0|||Wilcoxon rank sum|||||4|1|=0.002
74072246|NCT01545076|147696855|OTHER||Median Difference (Net)|3.0|||=|0.03|TWO_SIDED|95.0|0.0|9.0|||Wilcoxon rank sum|||||9|0|=0.03
74072247|NCT01545076|147696855|OTHER||Median Difference (Net)|5.0|||<|0.001|TWO_SIDED|95.0|2.0|9.0|||Wilcoxon rank sum|||||9|2|<0.001
74072248|NCT00860405|147696912|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a coefficient of variation of 0.363 and a desired power of 90 % with a type I level of 2.5 %, N=11 patients per treatment group were needed. The power was calculated by means of the software SAS, version 9.1.3, PROC POWER. Nevertheless, more patients were required for the assessment of safety, therefore 2 × 30 patients were planned to be included in this study.|Ratio of LS-means|0.98|||||TWO_SIDED|95.0|0.84|1.16||Null hypothesis tested by calculating a 2-sided 95% CI for ratio of LS-means μVoluven/μHSA based on ANOVA incl.treatment+centre as effects. If 95% CI was within equivalence range(0.55, 1.82), significant equivalence was concluded (Type I error: 2.5%)|ANOVA|Primary endpoint specified + analysed for PP and ITT population. Confirmatory analysis based on PP population only, no adjustment for multiplicity.|Considered ratio: μVoluven/μHSA = LS-mean of Voluven®/LS-mean of HSA 5%|The aim of the study was to prove equivalence, i.e. H0: μVoluven/μHSA ≤ 0.55 or μVoluven/μHSA ≥ 1.82 H1: 0.55 \< μVoluven/μHSA \< 1.82 where μVoluven was the mean infused volume of Voluven® and μHSA was the mean infused volume of HSA 5%.||1.16|0.84|
74072249|NCT00765648|147696921|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.3||||0.04|TWO_SIDED|95.0|-18.0|-0.6|||Chi-squared|||||-0.6|-18.0|0.04
74072250|NCT00765648|147696922|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
73883815|NCT02960217|147301247|SUPERIORITY|||||||0.2034|||||||Wilk-Shapiro Test for Normality|||||||0.2034
74072251|NCT00765648|147696923|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
74072252|NCT00765648|147696924|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Chi-squared|||||||0.38
74072253|NCT00765648|147696925|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED|95.0|||||Chi-squared|||||||0.18
74072254|NCT00765648|147696926|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
74072255|NCT01062256|147696935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.216|TWO_SIDED|95.0|0.64|1.1||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.10|0.64|0.216
74072256|NCT01062256|147696935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.513|TWO_SIDED|95.0|0.72|1.18||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.18|0.72|0.513
73883816|NCT02960217|147301248|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.56||0.1138|TWO_SIDED|95.0|-0.7|5.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||5.9|-0.7|0.1138
73883817|NCT02960217|147301248|SUPERIORITY|||||||0.1478|||||||Wilk-Shapiro Test for Normality|||||||0.1478
74072257|NCT01062256|147696935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.459|TWO_SIDED|95.0|0.87|1.38||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.38|0.87|0.459
74072258|NCT01062256|147696936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.195|TWO_SIDED|95.0|0.65|1.09||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.09|0.65|0.195
74072259|NCT01062256|147696936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.438|TWO_SIDED|95.0|0.71|1.16||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.16|0.71|0.438
74072260|NCT01062256|147696936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.497|TWO_SIDED|95.0|0.87|1.34||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.34|0.87|0.497
74072261|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.25|TWO_SIDED|95.0|0.64|1.12||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.12|0.64|0.250
74072262|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.802|TWO_SIDED|95.0|0.75|1.25||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.25|0.75|0.802
74072263|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.188|TWO_SIDED|95.0|0.94|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.39|0.94|0.188
74072264|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.091|TWO_SIDED|95.0|0.58|1.04||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.04|0.58|0.091
74072265|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.465|TWO_SIDED|95.0|0.69|1.19||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.19|0.69|0.465
74072266|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.207|TWO_SIDED|95.0|0.92|1.46||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.46|0.92|0.207
74072267|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.122|TWO_SIDED|95.0|0.62|1.06||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.06|0.62|0.122
74072268|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.165|TWO_SIDED|95.0|0.66|1.07||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.07|0.66|0.165
74072269|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.711|TWO_SIDED|95.0|0.83|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.32|0.83|0.711
74072270|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.215|TWO_SIDED|95.0|0.64|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.11|0.64|0.215
74072271|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.367|TWO_SIDED|95.0|0.67|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.16|0.67|0.367
74072272|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.687|TWO_SIDED|95.0|0.82|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.35|0.82|0.687
74072273|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.73|TWO_SIDED|95.0|0.67|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.32|0.67|0.730
73883818|NCT02960217|147301249|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.62||0.5505|TWO_SIDED|95.0|-4.6|2.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||2.6|-4.6|0.5505
74072274|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.923|TWO_SIDED|95.0|0.74|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.39|0.74|0.923
74072275|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.573|TWO_SIDED|95.0|0.83|1.4||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.40|0.83|0.573
74072276|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.289|TWO_SIDED|95.0|0.61|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.16|0.61|0.289
73883819|NCT02960217|147301249|SUPERIORITY|||||||0.4459|||||||Wilk-Shapiro Test for Normality|||||||0.4459
74072277|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.379|TWO_SIDED|95.0|0.64|1.18||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.18|0.64|0.379
74072278|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.785|TWO_SIDED|95.0|0.79|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.37|0.79|0.785
74072279|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.194|TWO_SIDED|95.0|0.6|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.11|0.60|0.194
74072280|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.212|TWO_SIDED|95.0|0.62|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.11|0.62|0.212
74072281|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.901|TWO_SIDED|95.0|0.77|1.34||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.34|0.77|0.901
74072282|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.6|TWO_SIDED|95.0|0.7|1.23||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.23|0.70|0.600
74072283|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.853|TWO_SIDED|95.0|0.74|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.29|0.74|0.853
74072284|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.736|TWO_SIDED|95.0|0.79|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.39|0.79|0.736
74072285|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.744|TWO_SIDED|95.0|0.7|1.3||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.30|0.70|0.744
74072286|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.904|TWO_SIDED|95.0|0.72|1.33||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.33|0.72|0.904
74072287|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.828|TWO_SIDED|95.0|0.77|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.39|0.77|0.828
74072288|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.147|TWO_SIDED|95.0|0.59|1.08||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.08|0.59|0.147
74072289|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.345|TWO_SIDED|95.0|0.65|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.16|0.65|0.345
74072290|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.532|TWO_SIDED|95.0|0.83|1.44||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.44|0.83|0.532
74072291|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.261|TWO_SIDED|95.0|0.61|1.15||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.15|0.61|0.261
74072292|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.601|TWO_SIDED|95.0|0.69|1.24||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.24|0.69|0.601
74072293|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.47|TWO_SIDED|95.0|0.84|1.47||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.47|0.84|0.470
73883820|NCT02960217|147301250|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.84||0.5544|TWO_SIDED|95.0|-8.1|4.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.6|-8.1|0.5544
74072294|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.834|TWO_SIDED|95.0|0.71|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.32|0.71|0.834
74072295|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.628|TWO_SIDED|95.0|0.81|1.43||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.43|0.81|0.628
74072296|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.481|TWO_SIDED|95.0|0.83|1.48||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.48|0.83|0.481
74072297|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.749|TWO_SIDED|95.0|0.65|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.37|0.65|0.749
74072298|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.857|TWO_SIDED|95.0|0.7|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.35|0.70|0.857
74072299|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.847|TWO_SIDED|95.0|0.76|1.41||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.41|0.76|0.847
74072300|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.146|TWO_SIDED|95.0|0.54|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.09|0.54|0.146
74072301|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.702|TWO_SIDED|95.0|0.69|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.29|0.69|0.702
74072302|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.228|TWO_SIDED|95.0|0.88|1.69||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.69|0.88|0.228
74072303|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.13|TWO_SIDED|95.0|0.51|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.09|0.51|0.130
74072304|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.371|TWO_SIDED|95.0|0.6|1.21||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.21|0.60|0.371
74072305|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.43|TWO_SIDED|95.0|0.82|1.58||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.58|0.82|0.430
74072306|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.177|TWO_SIDED|95.0|0.51|1.13||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.13|0.51|0.177
74072307|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.58|TWO_SIDED|95.0|0.64|1.28||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.28|0.64|0.580
74072308|NCT01062256|147696937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.333|TWO_SIDED|95.0|0.84|1.7||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.70|0.84|0.333
74072309|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.264|TWO_SIDED|95.0|-0.08|0.27||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.27|-0.08|0.264
73883821|NCT02960217|147301250|SUPERIORITY|||||||0.1104|||||||Wilk-Shapiro Test for Normality|||||||0.1104
74072310|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.737|TWO_SIDED|95.0|-0.2|0.14||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.14|-0.20|0.737
74072311|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.078|TWO_SIDED|95.0|-0.27|0.01||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.01|-0.27|0.078
73883822|NCT02960217|147301251|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|3.27||0.7145|TWO_SIDED|95.0|-8.5|6.1|||ANCOVA|||||6.1|-8.5|0.7145
73883823|NCT02960217|147301251|SUPERIORITY|||||||0.8255|||||||Wilk-Shapiro Test for Normality|||||||0.8255
74072312|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.125|TWO_SIDED|95.0|-0.04|0.36||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.36|-0.04|0.125
73883824|NCT02960217|147301252|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.82||0.4176|TWO_SIDED|95.0|-2.5|5.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||5.6|-2.5|0.4176
73883825|NCT02960217|147301252|SUPERIORITY|||||||0.6557|||||||Wilk-Shapiro Test for Normality|||||||0.6557
73883826|NCT02960217|147301253|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.09||0.0935|TWO_SIDED|95.0|-0.4|4.5||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.5|-0.4|0.0935
74072313|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.688|TWO_SIDED|95.0|-0.16|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.24|-0.16|0.688
74072314|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.166|TWO_SIDED|95.0|-0.29|0.05||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.05|-0.29|0.166
74072315|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.233|TWO_SIDED|95.0|-0.09|0.35||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.35|-0.09|0.233
74072316|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.848|TWO_SIDED|95.0|-0.24|0.19||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.19|-0.24|0.848
74072317|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.093|TWO_SIDED|95.0|-0.33|0.03||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.03|-0.33|0.093
74072318|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.406|TWO_SIDED|95.0|-0.14|0.34||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.34|-0.14|0.406
74072319|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.24|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.24|-0.24|0.991
74072320|NCT01062256|147696938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.306|TWO_SIDED|95.0|-0.3|0.09||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.09|-0.30|0.306
74072321|NCT01062256|147696939|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma statistic|0.15||||0.254|TWO_SIDED|95.0|-0.09|0.39||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.39|-0.09|0.254
73883827|NCT02960217|147301253|SUPERIORITY|||||||0.7267|||||||Wilk-Shapiro Test for Normality|||||||0.7267
74072322|NCT01062256|147696939|SUPERIORITY_OR_OTHER||weighted Goodman-Kruskal Gamma statistic|-0.01||||0.949|TWO_SIDED|95.0|-0.25|0.23||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.23|-0.25|0.949
74072323|NCT01062256|147696939|SUPERIORITY_OR_OTHER||weighted Goodman-Kruskal Gamma statistic|-0.12||||0.256|TWO_SIDED|95.0|-0.32|0.08||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.08|-0.32|0.256
74072324|NCT00891293|147696953|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.3|STANDARD_DEVIATION|29.01||0.9999||95.0|-2.8|9.4|||ANOVA||Difference Between Percent Change from LOV111859/OM5 Baseline to LOV111860/OM5X End-of-Treatment and Percent Change from LOV111859/OM5 Baseline to LOV111821/OM5XX End-of-Treatment|For the MITT analysis, the method of last observation carried forward (LOCF) was applied. The LOCF is the value of a previous non-baseline visit (post-enrollment) carried forward to the subsequent visit, if missing.||9.4|-2.8|0.9999
74072325|NCT00486837|147696973|SUPERIORITY_OR_OTHER|||||||0.197||95.0|||||ANCOVA|||||||0.197
74072326|NCT02724800|147696979|NON_INFERIORITY|non-inferiority margin = 3.43|Mean Difference (Net)|2.2|||<|0.05|TWO_SIDED|95.0|-0.9|5.6||a priori|Mixed Models Analysis|||||5.6|-0.9|<0.05
74072327|NCT02724800|147696986|SUPERIORITY||Mean Difference (Final Values)|2.3|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
74072328|NCT02724800|147696989|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
74072329|NCT00262964|147696993|SUPERIORITY_OR_OTHER||||||<|0.019||95.0|||||t-test, 2 sided|||null hypothesis was no difference in hepatic insulin sensitivity between normal and high IHTG subjects||||<0.019
74072330|NCT00262964|147696994|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||a priori threshold for significance was P\<0.05.|t-test, 2 sided|||null hypothesis was that VLDL-TG production would not differ between the two groups.||||<0.001
74072331|NCT00262964|147696995|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|||null hypothesis was no difference in skeletal muscle insulin sensitivity between groups.||||<0.001
74072332|NCT00262964|147696996|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||t-test, 2 sided|||null hypothesis was that there would be no difference in adipose tissue insulin sensitivity due to IHTG levels.||||<0.002
74072333|NCT00262964|147696997|SUPERIORITY_OR_OTHER|||||||0.301||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student's t-test was used.||Student's t-test for paired samples was used to evaluate any difference between the two groups. The null hypothesis was that the IHTG percentage would be the same before and after treatment for subjects receiving fenofibrate.||||.301
74072334|NCT00262964|147696997|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student's t-test was used.||A Student's t-test for paired samples was used to evaluate the effect of treatment. The null hypothesis was that the IHTG percentage for the NAFLD-niacin group at baseline and post-treatment would not change.||||.315
73883828|NCT02960217|147301254|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.8329|TWO_SIDED|95.0|-0.6|0.5||Based on an ANCOVA model including covariate for study baseline CGI-S score, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||0.5|-0.6|0.8329
73883829|NCT02960217|147301254|SUPERIORITY|||||||0.2348|||||||Wilk-Shapiro Test for Normality|||||||0.2348
73883830|NCT02960217|147301256|SUPERIORITY|||||||0.0315|||||||Wilk-Shapiro Test for Normality|||||||0.0315
73883831|NCT02960217|147301256|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|-0.5||||0.2425|TWO_SIDED|95.0|-1.5|0.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).||0.5|-1.5|0.2425
74072335|NCT00262964|147696998|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|||a Student's t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 16 weeks on niacin in subjects with NAFLD.||||0.708
74072336|NCT00262964|147696998|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|||A Student's t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 8 weeks on fenofibrate in subjects with NAFLD.||||.022
74072337|NCT00262964|147696999|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||the null hypothesis was that fenofibrate would not change the VLDL-Tg clearance rate||||.020
74072338|NCT00262964|147696999|SUPERIORITY_OR_OTHER|||||||0.358||95.0||||a priori threshold for significance was \<0.05.|t-test, 2 sided|||the null hypothesis was that niacin would not change the VLDL-Tg clearance rate||||.358
74072339|NCT00262964|147697000|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||a priori threshold for statistical significance was set at \<0.05.|t-test, 2 sided|||Null hypothesis is that fenofibrate would not effect VLDL-Tg production rates.||||0.758
74072340|NCT00262964|147697000|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||the a priori threshold for statistical significance was set at \<0.05.|t-test, 2 sided|||Null hypothesis is that niacin would not effect VLDL-Tg production rates.||||.023
74072341|NCT00262964|147697001|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||the a priori threshold for statistical significance was p \<0.05|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.||||.024
74072342|NCT00262964|147697001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||the a priori threshold for statistical significance was p\<0.05|t-test, 2 sided|||The null hypothesis was that niacin would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.||||<0.001
74072343|NCT00262964|147697002|SUPERIORITY_OR_OTHER|||||||0.768||95.0||||A priori threshold for significance was set for p\<0.05.|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect adipose tissue insulin sensitivity. We compare the baseline and post-treatment results for adipose tissue insulin sensitivity in the subjects who received fenofibrate.||||.768
74072344|NCT00262964|147697002|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||A priori threshold for significance was set for p\<0.05.|t-test, 2 sided|||Null hypothesis was that niacin would not affect adipose tissue insulin sensitivity. Here we compare the baseline and post-treatment adipose tissue insulin sensitivity results for subjects who received a 16 week course of niacin||||.019
74072345|NCT00262964|147697003|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results in subjects receiving an 8 week course of fenofibrate.||||.318
74072346|NCT00262964|147697003|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results for subjects receiving a 16 week course of niacin.||||.025
74072347|NCT00262964|147697004|SUPERIORITY_OR_OTHER|||||||0.419||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect hepatic insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.||||.419
74072348|NCT00262964|147697004|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.||||.018
74072349|NCT00796822|147697028|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|STANDARD_DEVIATION|1.09||0.44|TWO_SIDED|95.0|-1.53|3.28|||t-test, 2 sided|||The sample size was determined based on a two-sample, independent, two-tailed t-test with 5% type I error. Using the results from our pilot trial, we conservatively estimated a predicted absolute change in FMD of 3.5% with PTX (assuming no change with placebo) and we assumed a common standard deviation of 2.6%. A sample size of 10 per group was estimated to provide at least 80% power to detect this effect size. Allowing for a 20% dropout rate, we planned to recruit 13 subjects per group.||3.28|-1.53|0.44
74072350|NCT00796822|147697029|SUPERIORITY|There was no formal power calculation for this outcome measure as the study was powered on the primary outcome measure.|Median Difference (Net)|149.1|STANDARD_DEVIATION|151.8||0.03|TWO_SIDED|95.0|16.4|281.9|||t-test, 2 sided|||||281.9|16.4|0.03
74072351|NCT00577460|147697087|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX ER versus Placebo||||0.0039
74072352|NCT00577460|147697087|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX IR versus Placebo||||0.0001
74072353|NCT00577460|147697090|SUPERIORITY_OR_OTHER|||||||0.559||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.5590
74072354|NCT00577460|147697090|SUPERIORITY_OR_OTHER|||||||0.1289||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1289
74072355|NCT00577460|147697092|SUPERIORITY_OR_OTHER|||||||0.1073||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1073
74072356|NCT00577460|147697092|SUPERIORITY_OR_OTHER|||||||0.8694||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.8694
74072357|NCT00577460|147697093|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0009
74072358|NCT00577460|147697093|SUPERIORITY_OR_OTHER|||||||0.0573||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0573
74072359|NCT00577460|147697094|SUPERIORITY_OR_OTHER|||||||0.6434||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.6434
74072360|NCT00577460|147697094|SUPERIORITY_OR_OTHER|||||||0.2469||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.2469
74072361|NCT00577460|147697095|SUPERIORITY_OR_OTHER|||||||0.9741||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.9741
74072362|NCT00577460|147697095|SUPERIORITY_OR_OTHER|||||||0.762||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.7620
74072363|NCT00577460|147697099|SUPERIORITY_OR_OTHER|||||||0.0831||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0831
74072364|NCT00577460|147697099|SUPERIORITY_OR_OTHER|||||||0.0759||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0759
74072365|NCT00577460|147697100|SUPERIORITY_OR_OTHER|||||||0.1713||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1713
74072366|NCT00577460|147697100|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0130
73883832|NCT02960217|147301257|SUPERIORITY|||||||0.0072|||||||Wilk-Shapiro Test for Normality|||||||0.0072
74072367|NCT00577460|147697101|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0015
74072368|NCT00577460|147697101|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0002
74072369|NCT00577460|147697102|SUPERIORITY_OR_OTHER|||||||0.876||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.8760
74072370|NCT00577460|147697102|SUPERIORITY_OR_OTHER|||||||0.5113||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.5113
74072371|NCT00577460|147697103|SUPERIORITY_OR_OTHER|||||||0.0148||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0148
74072372|NCT00577460|147697103|SUPERIORITY_OR_OTHER|||||||0.0201||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0201
73883833|NCT02960217|147301257|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|0.0||||1|TWO_SIDED|95.0|-14.5|13.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=12).||13.5|-14.5|1.0000
74072373|NCT01988922|147697123|OTHER|Differences between CYP2B6\*1/\*1, CYP2B6\*1/\*6, and CYP2B6\*6/\*6 genotypes for pharmacokinetic parameters were analyzed using one-way ANOVA followed by the Student-Newman-Keuls test for multiple comparisons (Sigmaplot 12.5; Systat Software, Inc, USA). Nonnormal data were log transformed for analysis but reported as the nontransformed results.|||||<|0.05|||||||ANOVA|One-way ANOVA followed by the Student-Newman-Keuls test for multiple comparisons||||||<0.05
74072374|NCT01347710|147697124|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule|McNemar|Two-sided McNemar's (chi-squared) test superiority||||||<0.001
74072375|NCT01347710|147697125|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients under going pharmacologic stress|McNemar|Two-sided McNemar's (chi-squared) test superiority||||||<0.001
74072376|NCT01347710|147697125|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in females|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority||||||<0.001
74072377|NCT01347710|147697125|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients with BMI \>/=30|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority||||||<0.001
74072378|NCT01347710|147697126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.891|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in patients undergoing pharmacologic stress|Z test|z test for non inferiority for specificity||||||0.891
74072379|NCT01347710|147697126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.546|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in female patients|z test|z test for non-inferiority for specificity||||||.546
74072380|NCT01347710|147697126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.538|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule BMI \>/=30|z test|z test for non-inferiority for specificity||||||.538
74072381|NCT01347710|147697127|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|McNemar|Two-sided McNemar (chi-squared) test superiority for sensitivity; LAD||||||<0.001
74072382|NCT01347710|147697127|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; LCX||||||<0.001
74072383|NCT01347710|147697127|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; RCA||||||<0.001
74072384|NCT01347710|147697127|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; Non-LAD||||||<0.001
74072385|NCT01347710|147697128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.379|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|z Test|z test for non-inferiority for specificity; LAD||||||.379
74072386|NCT01347710|147697128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.358|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|Z Test|z test for non-inferiority for specificity; LCX||||||.358
74072387|NCT01347710|147697128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.442|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|z Test|z test for non-inferiority for specificity; RCA||||||.442
74072388|NCT01347710|147697128|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.984|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|z Test|z test for non-inferiority for specificity; non-LAD||||||.984
74072389|NCT01347710|147697129|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value of sensitivity for flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule; multivessel disease|McNemar|p-Value based on two-sided McNemar's (Chi squared) test superiority||||||<0.001
74072390|NCT01347710|147697130|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.827|TWO_SIDED|||||p-Value of specificity for comparison of flurpiridaz F18 PET MPI vs. SPECT MPI in detecting multivessel disease|z test|p-Value based on one-sided z test for non-inferiority||||||0.827
74072391|NCT01347710|147697131|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality of excellent or good|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity||||||<0.001
74072392|NCT01347710|147697132|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study protocol number BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.945|ONE_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI|Z Test|one-sided z test for non-inferiority for specificity||||||.945
74072393|NCT01347710|147697133|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.954|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality excellent/good|z Test|p-Value based on on-sided z test for non-inferiority for specificity||||||0.954
74072394|NCT01347710|147697134|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
74072395|NCT01347710|147697135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||McNemar|p-Values are from 2-sided McNemar's test of comparison in proportion of patients with definitely diagnositic certainty between PET and SPECT||||||<0.001
74072396|NCT04591626|147697136|SUPERIORITY||LS Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.14|-0.77|||Mixed Models Analysis|||||-0.77|-1.14|<0.001
74072397|NCT04591626|147697137|SUPERIORITY||Odds Ratio (OR)|10.91|||<|0.001|TWO_SIDED|95.0|5.35|22.28|||Regression, Logistic|||||22.28|5.35|<0.001
73883834|NCT02960217|147301258|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.54||0.1076|TWO_SIDED|95.0|-0.3|2.2||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||2.2|-0.3|0.1076
74072398|NCT04591626|147697138|SUPERIORITY||LS Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.77|-0.6|||Mixed Models Analysis|||||-0.60|-1.77|<0.001
74072399|NCT04591626|147697139|SUPERIORITY||LS Mean Difference|-14.82|||<|0.001|TWO_SIDED|95.0|-20.57|-9.08|||Mixed Models Analysis|||||-9.08|-20.57|<0.001
74072400|NCT04591626|147697140|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.64|7.95|||Regression, Logistic||OR was determined using Logistic Regression model with Baseline HbA1c value + OAM use + Treatment as variables.|||7.95|2.64|<0.001
74072401|NCT04591626|147697141|SUPERIORITY||Odds Ratio (OR)|7.59|||<|0.001|TWO_SIDED|95.0|4.27|13.48|||Regression, Logistic||OR was determined using logistic regression model: Variable = Baseline HbA1c value + OAM use + Treatment as variables.|||13.48|4.27|<0.001
74072402|NCT04591626|147697142|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.64|7.95|||Regression, Logistic||OR was determined using logistic regression model with Baseline HbA1c value + OAM use + Treatment as variables.|||7.95|2.64|<0.001
74072403|NCT04591626|147697143|SUPERIORITY||LS Mean Difference|-26.3|||<|0.001|TWO_SIDED|95.0|-33.0|-19.6|||Mixed Models Analysis|||||-19.6|-33.0|<0.001
74072404|NCT04591626|147697144|SUPERIORITY||LS Mean Difference|-4.0||||0.006|TWO_SIDED|95.0|-6.86|-1.14|||Mixed Models Analysis|||||-1.14|-6.86|0.006
74072405|NCT02672553|147697159|SUPERIORITY||Median Difference (Final Values)|-12.5|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74072406|NCT02672553|147697160|SUPERIORITY||Median Difference (Final Values)|-10.5||||0.2077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2077
74072407|NCT01606306|147697187|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||Rank-ordered logistic regression (ROLR) was used to model the probability of best response for each treatment and bootstrapping was used to calculate confidence intervals.|rank-order logistic regression|ROLR is in the class of Discrete Choice models, which seek to estimate the probability that an individual responds best to a specific treatments.||The primary analysis tested the null hypothesis of all three treatments having equal probability to yield the best response as defined by the criteria defining the primary outcome. A sample size of 300 participants was selected to test the primary null hypothesis of all three treatments having equal probability (one-third) to yield the best response with statistical power of at least 0.90 if any one of the three treatments actually has probability of at least one-half to yield the best response.|The probabilistic construct of the Discrete Choice (DC) model does not reflect individual behavior that is intrinsically probabilistic, but rather population heterogeneity. DC models rely on stochastic assumptions to account for unobserved factors related to the treatments themselves and to characteristics of study participants. Specifically, that each treatment has an underlying utility that may differ from one individual to another. Mathematically, these utilities are represented by U\_t, where t denotes the treatment. Utility can be thought of as a latent variable quantifying treatment response where higher values indicate better response. The U\_t can be used to find the probability (P) of best response for each treatment by the following equation: P\_t = exp(U\_t) / \[exp(U\_A) + exp(U\_B) + exp(U\_C)\], where A, B, and C, denote the three study treatments. The primary analysis tested whether the three treatments have equal utility and, thus, equal probability of best response.|||<0.0001
74072408|NCT00970281|147697193|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was based on an analysis of variance (ANOVA) model that included treatment and site as a factor.|ANOVA|||Sample size of at least 45 participants per group was necessary to verify decreases in PANSS-EC total score were significantly greater in olanzapine group than placebo group using a t-test with a power of 90% and a 2-sided significance level of 5%.||||<0.001
74072409|NCT00970281|147697194|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||This is the p-value for 0.25 hour after first IM injection.|ANOVA|||||||0.009
74072410|NCT00970281|147697194|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 0.50 hour after first IM injection.|ANOVA|||||||<0.001
74072411|NCT00970281|147697194|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 1 hour after first IM injection.|ANOVA|||||||<0.001
74072412|NCT00970281|147697194|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 1.5 hour after first IM injection.|ANOVA|||||||<0.001
74072413|NCT00970281|147697195|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANOVA|||||||0.008
74072414|NCT00970281|147697196|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Fisher Exact|||||||0.008
74072415|NCT00970281|147697197|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||This is the p-value for the 0.5 hour after the first IM injection.|Fisher Exact|||||||0.167
74072416|NCT00970281|147697197|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||This is the p-value for the 1 hour after the first IM injection.|Fisher Exact|||||||0.134
73883835|NCT02960217|147301258|SUPERIORITY|||||||0.7698|||||||Wilk-Shapiro Test for Normality|||||||0.7698
74072417|NCT00970281|147697197|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p-value for the 1.5 hour after the first IM injection.|Fisher Exact|||||||0.008
74072418|NCT00970281|147697197|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p-value for the 2 hours after the first IM injection.|Fisher Exact|||||||0.008
73883836|NCT02960217|147301259|SUPERIORITY|||||||0.0138|||||||Wilk-Shapiro Test for Normality|||||||0.0138
73883837|NCT02960217|147301259|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|2.0||||0.3907|TWO_SIDED|95.0|-3.5|20.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).||20.5|-3.5|0.3907
73883838|NCT02960217|147301260|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.51||0.5233|TWO_SIDED|95.0|-4.4|2.4||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||2.4|-4.4|0.5233
74072419|NCT00970281|147697197|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||This is the p-value for the 24 hours after the first IM injection.|Fisher Exact|||||||0.204
74072420|NCT00970281|147697198|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the p-value for Parkinsonism.|Fisher Exact|||||||1.000
73883839|NCT02960217|147301260|SUPERIORITY|||||||0.6918|||||||Wilk-Shapiro Test for Normality|||||||0.6918
73883840|NCT01743469|147301267|SUPERIORITY_OR_OTHER|||||||0.142||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>20%).||||0.142
73883841|NCT01743469|147301267|SUPERIORITY_OR_OTHER|||||||1||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>35%).||||1.000
74072421|NCT03676803|147697199|OTHER||Mean Difference (Final Values)|10.6||||0.033|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Firmicutes abundance between groups.||||0.033
74072422|NCT03676803|147697199|OTHER||Mean Difference (Final Values)|8.7||||0.097|TWO_SIDED|||||p\<0.05 was defined as significant.|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Bacteroidetes abundance between groups.||||0.097
74072423|NCT03676803|147697200|OTHER||Mean Difference (Final Values)|86.0||||0.49|TWO_SIDED||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in mixed spices intervention group||||0.49
74072424|NCT03676803|147697200|OTHER||Mean Difference (Final Values)|55.7||||0.53|TWO_SIDED||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in placebo group||||0.53
74072425|NCT01355081|147697256|SUPERIORITY_OR_OTHER||Least square means difference|-2.03|STANDARD_ERROR_OF_MEAN|1.241||0.1031|TWO_SIDED|95.0|-4.467|0.413|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.||||0.413|-4.467|0.1031
74072426|NCT01355081|147697256|SUPERIORITY_OR_OTHER||Least square mean difference|-1.04|STANDARD_ERROR_OF_MEAN|1.233||0.4008|TWO_SIDED|95.0|-3.461|1.387|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.||||1.387|-3.461|0.4008
74072427|NCT02480764|147697262|NON_INFERIORITY|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-1.932|STANDARD_ERROR_OF_MEAN|1.4512||0.184|TWO_SIDED|95.0|-4.782|0.918||Change at Week 8: P-value was calculated using analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA|||||0.918|-4.782|0.184
74072428|NCT02480764|147697262|NON_INFERIORITY|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-3.685|STANDARD_ERROR_OF_MEAN|1.4344||0.01|TWO_SIDED|95.0|-6.502|-0.868||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA|||||-0.868|-6.502|0.010
74072429|NCT02480764|147697263|OTHER||Least Square Mean Difference|-1.459|STANDARD_ERROR_OF_MEAN|0.9455||0.123|TWO_SIDED|95.0|-3.316|0.397||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA|||||0.397|-3.316|0.123
74072430|NCT02480764|147697263|OTHER||Least Square Mean Difference|-2.822|STANDARD_ERROR_OF_MEAN|0.9354||0.003|TWO_SIDED|95.0|-4.659|-0.985||Change at 8 Week: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA|||||-0.985|-4.659|0.003
73883842|NCT01743469|147301267|SUPERIORITY_OR_OTHER|||||||0.8||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>20%).||||0.800
73883843|NCT01743469|147301267|SUPERIORITY_OR_OTHER|||||||0.63||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>15%).||||0.630
73883844|NCT01743469|147301268|SUPERIORITY_OR_OTHER|||||||0.5||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with a prespecified threshold (\>20%).||||0.500
73883845|NCT00168844|147301287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
73883846|NCT00168844|147301287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
73883847|NCT00168844|147301288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.269|STANDARD_ERROR_OF_MEAN|0.996||0.0011||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||0.0011
74072431|NCT02480764|147697264|OTHER||Odds Ratio (OR)|0.877|STANDARD_ERROR_OF_MEAN|0.192||0.548|TWO_SIDED|95.0|0.571|1.347||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.347|0.571|0.548
74072432|NCT02480764|147697264|OTHER||Odds Ratio (OR)|0.979|STANDARD_ERROR_OF_MEAN|0.2136||0.921|TWO_SIDED|95.0|0.638|1.501||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.501|0.638|0.921
74072433|NCT02480764|147697265|OTHER||Odds Ratio (OR)|1.033|STANDARD_ERROR_OF_MEAN|0.2805||0.904|TWO_SIDED|95.0|0.607|1.759||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.759|0.607|0.904
74072434|NCT02480764|147697265|OTHER||Odds Ratio (OR)|1.074|STANDARD_ERROR_OF_MEAN|0.2897||0.79|TWO_SIDED|95.0|0.633|1.823||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.823|0.633|0.790
74072435|NCT02480764|147697266|OTHER||Odds Ratio (OR)|0.901|STANDARD_ERROR_OF_MEAN|0.1916||0.624|TWO_SIDED|95.0|0.594|1.367||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.367|0.594|0.624
74072436|NCT02480764|147697266|OTHER||Odds Ratio (OR)|1.103|STANDARD_ERROR_OF_MEAN|0.235||0.647|TWO_SIDED|95.0|0.726|1.674||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.674|0.726|0.647
74072437|NCT02480764|147697267|OTHER||Odds Ratio (OR)|0.831|STANDARD_ERROR_OF_MEAN|0.1846||0.404|TWO_SIDED|95.0|0.537|1.284||Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.284|0.537|0.404
74072438|NCT02480764|147697267|OTHER||Odds Ratio (OR)|0.937|STANDARD_ERROR_OF_MEAN|0.2078||0.768|TWO_SIDED|95.0|0.606|1.447||Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.447|0.606|0.768
74072439|NCT02480764|147697267|OTHER||Odds Ratio (OR)|1.051|STANDARD_ERROR_OF_MEAN|0.2837||0.852|TWO_SIDED|95.0|0.62|1.784||Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.784|0.620|0.852
74072440|NCT02480764|147697267|OTHER||Odds Ratio (OR)|1.045|STANDARD_ERROR_OF_MEAN|0.2788||0.868|TWO_SIDED|95.0|0.62|1.763||Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.763|0.620|0.868
74072441|NCT02480764|147697267|OTHER||Odds Ratio (OR)|1.042|STANDARD_ERROR_OF_MEAN|0.2244||0.847|TWO_SIDED|95.0|0.684|1.59||Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.590|0.684|0.847
74072442|NCT02480764|147697267|OTHER||Odds Ratio (OR)|1.172|STANDARD_ERROR_OF_MEAN|0.2517||0.46|TWO_SIDED|95.0|0.769|1.785||Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.785|0.769|0.460
74072443|NCT02480764|147697268|OTHER||Odds Ratio (OR)|1.487|STANDARD_ERROR_OF_MEAN|0.3333||0.077|TWO_SIDED|95.0|0.958|2.307||Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.307|0.958|0.077
74072444|NCT02480764|147697268|OTHER||Odds Ratio (OR)|1.914|STANDARD_ERROR_OF_MEAN|0.4229||0.003|TWO_SIDED|95.0|1.241|2.951||Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.951|1.241|0.003
73883848|NCT00168844|147301288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.242|STANDARD_ERROR_OF_MEAN|0.999|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
74072445|NCT02480764|147697268|OTHER||Odds Ratio (OR)|1.427|STANDARD_ERROR_OF_MEAN|0.3414||0.137|TWO_SIDED|95.0|0.893|2.28||Clinic DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||2.280|0.893|0.137
74072446|NCT02480764|147697268|OTHER||Odds Ratio (OR)|2.017|STANDARD_ERROR_OF_MEAN|0.4816||0.003|TWO_SIDED|95.0|1.263|3.22||Clinic DBP \<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||3.220|1.263|0.003
74072447|NCT02480764|147697268|OTHER||Odds Ratio (OR)|1.424|STANDARD_ERROR_OF_MEAN|0.3407||0.14|TWO_SIDED|95.0|0.891|2.276||Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.276|0.891|0.140
73883849|NCT00168844|147301289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_ERROR_OF_MEAN|0.165|<|0.0001|TWO_SIDED|95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
74072448|NCT02480764|147697268|OTHER||Odds Ratio (OR)|1.769|STANDARD_ERROR_OF_MEAN|0.4136||0.015|TWO_SIDED|95.0|1.118|2.797||Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.797|1.118|0.015
74072449|NCT01475474|147697269|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in ABL different from zero||||<0.001
74072450|NCT01475474|147697270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in Wexner score||||<0.001
73883850|NCT00168844|147301289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.075|STANDARD_ERROR_OF_MEAN|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.||||||<0.0001
73883851|NCT00168844|147301290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.782||||0.0002|TWO_SIDED|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg - Placebo|||0.890|0.687|0.0002
74072451|NCT01046253|147697271|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||TWO_SIDED|90.0|97.4|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|97.4|
74072452|NCT01046253|147697272|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.5|||||TWO_SIDED|90.0|93.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|93.3|
74072453|NCT01046253|147697273|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Slope|98.0|||||TWO_SIDED|90.0|92.8|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|92.8|
74072454|NCT00860028|147697304|SUPERIORITY_OR_OTHER_LEGACY|||||||0.36||95.0|||||Chi-squared|||||||0.36
74072455|NCT00860028|147697305|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||General Linear Model|||||||0.06
74072456|NCT00860028|147697306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Fisher Exact|||||||0.03
74072457|NCT01658943|147697310|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Log Rank|||||||0.15
74072458|NCT02130466|147697339|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.29|0.74|||||Cox regression model|||0.74|0.29|
74072459|NCT02130466|147697346|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.38|0.95|||||Cox regression model|||0.95|0.38|
73883852|NCT00168844|147301290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.725|||<|0.0001|TWO_SIDED|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg - Placebo|||0.828|0.635|<0.0001
73883853|NCT00168844|147301334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
74072460|NCT04529109|147697407|SUPERIORITY|The superiority of the Test lens was concluded if the lower limit of the 95% credible interval was above 0.90.|Mean Proportion|0.9998|STANDARD_DEVIATION|0.0005|||TWO_SIDED|95.0|0.999|1.0|||Bayesian Binary model||Interval presented is a 95% Credible interval.|||1.000|0.999|
74072461|NCT00890981|147697423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.0766||95.0|-0.4|7.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms with treatment-by-time interaction||7.8|-0.4|0.0766
74072462|NCT00890981|147697424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1648||95.0|-0.6|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|-0.6|0.1648
74072463|NCT00890981|147697425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.0228||95.0|0.1|1.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.||1.7|0.1|0.0228
74072464|NCT00890981|147697426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.656||95.0|-2.5|4.0|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model includes linear, quadratic and cubic time terms but without treatment-by-time interaction.||4.0|-2.5|0.6560
74072465|NCT00890981|147697427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.0594||95.0|-0.1|3.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.7|-0.1|0.0594
74072466|NCT00890981|147697428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0032||95.0|0.9|4.3|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||4.3|0.9|0.0032
74072467|NCT00890981|147697429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.2897||95.0|-0.4|1.2|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.||1.2|-0.4|0.2897
74072468|NCT00890981|147697430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.0067||95.0|1.1|6.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||6.7|1.1|0.0067
74072469|NCT00890981|147697431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.0184||95.0|0.4|3.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.8|0.4|0.0184
74072470|NCT00890981|147697432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.0911||95.0|-0.3|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|-0.3|0.0911
74072471|NCT00890981|147697433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.0035||95.0|0.7|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|0.7|0.0035
74072472|NCT00890981|147697434|SUPERIORITY_OR_OTHER||Ratio of Denosumab to Placebo|1.1||||0.0591||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||1.3|1.0|0.0591
74072473|NCT00890981|147697435|SUPERIORITY_OR_OTHER||Ratio of Denosumab to Placebo|1.2||||0.0079||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||1.3|1.0|0.0079
74072474|NCT00453362|147697436|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.017|TWO_SIDED|95.0|0.11|0.87||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG Responders would have prolonged PFS compared with FDG Non-Responders.||0.87|0.11|0.017
74072475|NCT00453362|147697438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.076|TWO_SIDED|95.0|0.06|1.42||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have a prolonged PFS compared to FDG Progressive Disease.||1.42|0.06|0.076
74072476|NCT00453362|147697440|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.17||||0.008|TWO_SIDED|95.0|0.04|0.73||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in PFS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged PFS compared with FLT Non-Responders.||0.73|0.04|0.008
74072477|NCT00453362|147697441|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank|||The null hypothesis is that there is no difference between FLT Responders and FLT Progressive Disease. Alternative hypothesis is that FLT responders would have prolonged PFS compared to FLT Progressive Disease.||||0.049
73883854|NCT00168844|147301334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
73883855|NCT00168844|147301335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
74072478|NCT00453362|147697442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.073|TWO_SIDED|95.0|0.11|1.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in OS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG responders would have prolonged OS compared with FDG Non-Responders.||1.16|0.11|0.073
74072479|NCT00453362|147697445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.618|TWO_SIDED|95.0|0.14|3.21||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in Overall Survival between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have prolonged OS compared with FDG Progressive Disease.||3.21|0.14|0.618
74072480|NCT00453362|147697446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.163|TWO_SIDED|95.0|0.09|1.57||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Non-Responders.||1.57|0.09|0.163
74072481|NCT00453362|147697447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.327|TWO_SIDED|95.0|0.04|3.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Progressive Disease.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Progressive Disease. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Progressive Disease.||3.16|0.04|0.327
74072482|NCT00153803|147697449|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.165|TWO_SIDED|95.0|0.65|1.33|||Log Rank|||||1.33|0.65|0.165
74072483|NCT00153803|147697450|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.32|TWO_SIDED|95.0|0.85|1.63|||Log Rank|||||1.63|0.85|0.32
74072484|NCT04885296|147697454|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|95.0|-2.2|3.0|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||3.0|-2.2|
74072485|NCT04885296|147697455|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.62|||TWO_SIDED|95.0|-4.0|2.3|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||2.3|-4.0|
74072486|NCT04885296|147697456|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-4.7|1.7|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||1.7|-4.7|
74072487|NCT00862979|147697457|SUPERIORITY||Mean Difference (Net)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.5|-6.1|||ANCOVA|||||-6.1|-16.5|<.0001
73883856|NCT00168844|147301335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
74072488|NCT00862979|147697458|OTHER|difference||||||0.203|||||||Fisher Exact|||Month 6 to Month 9||||0.203
74072489|NCT00862979|147697458|OTHER|difference||||||0.002|||||||Fisher Exact|||Month 9 to Month 18||||0.002
74072490|NCT00862979|147697460|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-19.6|-8.3|||ANCOVA|||Month 12||-8.3|-19.6|<.0001
74072491|NCT00862979|147697460|SUPERIORITY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.5|-6.1|||ANCOVA|||Month 18||-6.1|-16.5|<.0001
74072492|NCT00862979|147697462|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
74072493|NCT03100903|147697463|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean ratio (%)|71.64|||||TWO_SIDED|90.0|60.57|84.73|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 23.7"|||84.73|60.57|
74072494|NCT03100903|147697464|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean (gMean) Ratio %|29.29|||||TWO_SIDED|90.0|24.27|35.35|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 26.6"|||35.35|24.27|
74072495|NCT03100903|147697465|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean (gMean) Ratio %|70.22|||||TWO_SIDED|90.0|59.26|83.2|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 23.9"|||83.20|59.26|
74072496|NCT01882647|147697468|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.||||||<0.001
74072497|NCT01882647|147697469|SUPERIORITY_OR_OTHER||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
74072498|NCT01882647|147697470|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.01
74072499|NCT01882647|147697471|SUPERIORITY_OR_OTHER||||||<|0.01||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.01
74072500|NCT01027143|147697475|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
74072501|NCT03292653|147697487|SUPERIORITY||Difference in Least Squares (LS) Means|1.26|STANDARD_ERROR_OF_MEAN|3.64||0.736|TWO_SIDED|90.0|-5.4|7.93|||ANCOVA|||Analysis of Covariance (ANCOVA) model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||7.93|-5.4|0.736
74072502|NCT03292653|147697487|SUPERIORITY||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|3.38||0.7694|TWO_SIDED|90.0|-7.22|5.18|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||5.18|-7.22|0.7694
74072503|NCT03292653|147697488|SUPERIORITY||Difference in LS Means|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.184|TWO_SIDED|90.0|-0.09|0.01|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||0.01|-0.09|0.184
74072504|NCT03292653|147697488|SUPERIORITY||Difference in LS Means|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3397|TWO_SIDED|90.0|-0.07|0.02|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||0.02|-0.07|0.3397
74072505|NCT03292653|147697489|SUPERIORITY||Difference in LS Means|-17.07|STANDARD_ERROR_OF_MEAN|9.12||0.094|TWO_SIDED|90.0|-33.79|-0.35|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||-0.35|-33.79|0.094
74072506|NCT03292653|147697489|SUPERIORITY||Difference in LS Means|-12.09|STANDARD_ERROR_OF_MEAN|8.49||0.1878|TWO_SIDED|90.0|-27.65|3.46|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||3.46|-27.65|0.1878
73883857|NCT00168844|147301336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
73883858|NCT00168844|147301336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
74072507|NCT03292653|147697490|SUPERIORITY||Difference in LS Means|-4.82|STANDARD_ERROR_OF_MEAN|5.8||0.4269|TWO_SIDED|90.0|-15.45|5.8|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||5.8|-15.45|0.4269
74072508|NCT03292653|147697490|SUPERIORITY||Difference in LS Means|-6.36|STANDARD_ERROR_OF_MEAN|5.39||0.2684|TWO_SIDED|90.0|-16.24|3.52|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||3.52|-16.24|0.2684
74072509|NCT03292653|147697491|SUPERIORITY||Difference in LS Means|847.2|STANDARD_ERROR_OF_MEAN|576.98||0.1761|TWO_SIDED|90.0|-210.46|1904.86|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||1904.86|-210.46|0.1761
74072510|NCT03292653|147697491|SUPERIORITY||Difference in LS Means|489.33|STANDARD_ERROR_OF_MEAN|579.35||0.4202|TWO_SIDED|90.0|-572.68|1551.34|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||1551.34|-572.68|0.4202
74072511|NCT03292653|147697492|SUPERIORITY||Difference in LS Means|13.75|STANDARD_ERROR_OF_MEAN|8.53||0.1242|TWO_SIDED|90.0|-1.03|28.53|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.||28.53|-1.03|0.1242
74072512|NCT03292653|147697492|SUPERIORITY||Difference in LS Means|0.1|STANDARD_ERROR_OF_MEAN|7.73||0.9903|TWO_SIDED|90.0|-13.49|13.3|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.||13.30|-13.49|0.9903
73883859|NCT00168844|147301337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
73883860|NCT00168844|147301337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.1|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
73883861|NCT00168844|147301338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
74072513|NCT03292653|147697493|SUPERIORITY||Difference in LS Means|-150.89|STANDARD_ERROR_OF_MEAN|116.09||0.2121|TWO_SIDED|90.0|-353.57|51.78|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.||51.78|-353.57|0.2121
74072514|NCT03292653|147697493|SUPERIORITY||Difference in LS Means|-5.26|STANDARD_ERROR_OF_MEAN|96.88||0.9574|TWO_SIDED|90.0|-174.4|163.87|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.||163.87|-174.4|0.9574
74072515|NCT02564263|147697510|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.00894|TWO_SIDED|95.0|0.63|0.96||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)|||0.96|0.63|0.00894
74072516|NCT02564263|147697511|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.00855|TWO_SIDED|95.0|0.52|0.94||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])|||0.94|0.52|0.00855
74072517|NCT02564263|147697512|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0531|TWO_SIDED|95.0|0.75|1.05||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])|||1.05|0.75|0.0531
74072518|NCT02564263|147697513|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.287|TWO_SIDED|95.0|0.94|1.31||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)|||1.31|0.94|0.287
73883862|NCT00168844|147301338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
74072519|NCT02564263|147697514|SUPERIORITY||Difference in Percentages|6.4||||0.0037|TWO_SIDED|95.0|1.7|11.2||One-sided p-value for testing. H0: difference in %=0 versus; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)|||11.2|1.7|0.0037
74072520|NCT02564263|147697515|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.216|TWO_SIDED|95.0|0.75|1.13||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)|||1.13|0.75|0.216
74072521|NCT02564263|147697516|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.015|TWO_SIDED|95.0|0.54|0.97||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)|||0.97|0.54|0.015
74072522|NCT02564263|147697517|SUPERIORITY||Difference in Percentages|9.2||||0.0022|TWO_SIDED|95.0|3.0|15.8||One-sided p-value for testing. H0: difference in %=0; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW)|||15.8|3.0|0.0022
74072523|NCT02564263|147697518|SUPERIORITY||Difference in Percentages|15.1||||0.0006|TWO_SIDED|95.0|6.2|24.7||One-sided p-value for testing. H0: difference in %=0; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)|||24.7|6.2|0.0006
74072524|NCT03311646|147697521|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.07||||0.92|TWO_SIDED|95.0|-1.27|1.4||alpha=0.05.|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p-value: p=0.27|1.4|-1.27|0.92
73883863|NCT00168844|147301339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
74072525|NCT03311646|147697522|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|1.13||||0.15|TWO_SIDED|95.0|-0.41|2.66||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of cigarette per day during VLNC condition to cigarette per day during the NNC (baseline) condition.|Interaction p=0.23|2.66|-0.41|0.15
74072526|NCT03311646|147697523|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|3.19|||<|0.001|TWO_SIDED|95.0|1.77|4.6|||Mixed Models Analysis||Mean Difference=VLNC-NNC|Comparison of Minnesota Nicotine Withdrawal Scale during VLNC condition to Minnesota Nicotine Withdrawal Scale during the NNC (baseline) condition.|Interaction p=0.95|4.60|1.77|<0.001
74072527|NCT03311646|147697524|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.2||||0.84|TWO_SIDED|95.0|-2.0|2.5||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p=0.94|2.5|-2.0|0.84
74072528|NCT00683020|147697526|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|0.9||0.03|TWO_SIDED|95.0|0.1|3.9|||Regression, Linear|Adjusted for baseline values.||||3.9|0.1|0.03
74072529|NCT00683020|147697527|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.2||0.23|TWO_SIDED|95.0|-0.9|3.6|||Regression, Linear|Adjusted for baseline values.||||3.6|-0.9|0.23
74072530|NCT00683020|147697528|NON_INFERIORITY_OR_EQUIVALENCE|Days in comparison groups are not equal.|Rate Ratio|0.6||||0.25|TWO_SIDED|95.0|0.3|1.4|||Negative Binomial Models|Adjusted for baseline values.||||1.4|0.3|0.25
74072531|NCT00683020|147697529|NON_INFERIORITY_OR_EQUIVALENCE|Proportions in comparison groups are not equal.|Odds Ratio (OR)|0.5||||0.18|TWO_SIDED|95.0|0.2|1.4|||Regression, Logistic|Adjusted for baseline values.||||1.4|0.2|0.18
74072532|NCT00683020|147697530|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|0.1|0.5|||Regression, Linear|Adjusted for baseline values.||||0.5|0.1|0.008
74072533|NCT00683020|147697531|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.87|TWO_SIDED|95.0|-0.2|0.2|||Regression, Linear|Adjusted for baseline values.||||0.2|-0.2|0.87
74072534|NCT00683020|147697532|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.6||0.49|TWO_SIDED|95.0|-2.1|4.2|||Regression, Linear|Adjusted for baseline values.||||4.2|-2.1|0.49
73883864|NCT00168844|147301339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
73883865|NCT01283555|147301393|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||The p-value presented here represents a comparison of the total number of non-iatrogenic findings at baseline and after one week of product use.|Fisher Exact|||Fishers exact test was used to compare the frequency of non-iatrogenic colposcopic findings at baseline and follow-up visits (after one week of twice-daily product use).||||0.4870
74072535|NCT00683020|147697533|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.2||0.54|TWO_SIDED|95.0|-3.0|5.6|||Regression, Linear|Adjusted for baseline values.||||5.6|-3.0|0.54
74072536|NCT00683020|147697534|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.11|TWO_SIDED|95.0|-0.4|4.4|||Regression, Linear|Adjusted for baseline values.||||4.4|-0.4|0.11
74072537|NCT00683020|147697535|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED|95.0|-0.6|0.1|||Regression, Linear|Adjusted for baseline values.||||0.1|-0.6|0.13
74072538|NCT00683020|147697536|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|2.3||0.78|TWO_SIDED|95.0|-3.8|5.1|||Regression, Linear|Adjusted for baseline values.||||5.1|-3.8|0.78
74072539|NCT00683020|147697537|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.4||0.13|TWO_SIDED|95.0|-0.6|4.9|||Regression, Linear|Adjusted for baseline values.||||4.9|-0.6|0.13
74072540|NCT03127137|147697552|SUPERIORITY|||||||0.05||||||The reported p-value was calculated.|Fisher Exact|||||||.05
74072541|NCT03127137|147697553|SUPERIORITY||Risk Ratio (RR)|1.53|||||TWO_SIDED|95.0|0.82|2.86||||||||2.86|.82|
74072542|NCT02252562|147697556|EQUIVALENCE|We hypothesized a potential 66% reduction from a baseline incidence of 0.16 on the basis of prior interventions, but we assumed for power considerations a more conservative reduction of 40% from a baseline incidence of 0.12 averaged across all patients in each arm. Assuming a 10% loss to follow-up, we required 1,600 patients per group for a power of 0.9 with a type 1 error of .05.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.82|1.4|||fixed effects univariable analysis|||||1.40|0.82|
73883866|NCT01446159|147301400|SUPERIORITY||Hazard Ratio (HR)|0.991||||0.86|TWO_SIDED|95.0|0.689|1.429|||Log Rank|||||1.429|0.689|0.86
73888346|NCT02683577|147309563|SUPERIORITY_OR_OTHER||Geometric least square (LS) mean ratio|1.695|||||TWO_SIDED|90.0|0.904|3.176|||||A repeated-measures analysis of variance (ANOVA) was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.||3.176|0.904|
74072543|NCT02319148|147697561|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|105.28|||||TWO_SIDED|90.0|92.11|120.34|||Mixed Models Analysis|||||120.34|92.11|
74072544|NCT02319148|147697561|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|92.54|||||TWO_SIDED|90.0|80.96|105.77|||Mixed Models Analysis|||||105.77|80.96|
74072545|NCT02319148|147697561|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|116.36|||||TWO_SIDED|90.0|101.86|132.92|||Mixed Models Analysis|||||132.92|101.86|
74072546|NCT02319148|147697562|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|90.16|||||TWO_SIDED|90.0|78.57|103.46|||Mixed Models Analysis|||||103.46|78.57|
74072547|NCT02319148|147697562|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.38|||||TWO_SIDED|90.0|92.7|122.07|||Mixed Models Analysis|||||122.07|92.70|
74072548|NCT02319148|147697562|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|101.71|||||TWO_SIDED|90.0|88.68|116.66|||Mixed Models Analysis|||||116.66|88.68|
74072549|NCT02319148|147697563|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.33|||||TWO_SIDED|90.0|79.49|104.94|||Mixed Models Analysis|||||104.94|79.49|
74072550|NCT02319148|147697563|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.97|||||TWO_SIDED|90.0|93.1|122.91|||Mixed Models Analysis|||||122.91|93.10|
74072551|NCT02319148|147697563|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|102.69|||||TWO_SIDED|90.0|89.42|117.93|||Mixed Models Analysis|||||117.93|89.42|
74072552|NCT01249664|147697595|SUPERIORITY_OR_OTHER||Difference in least square means|14.1|||<|0.0001|TWO_SIDED|95.0|10.8|17.4||No adjustment on P value, this is for the primary efficacy analysis.|ANCOVA|ANCOVA model, including treatment groups and country (country designations) as fixed effects and baseline BCVA as a covariate.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham.||17.4|10.8|<0.0001
74072553|NCT01249664|147697596|SUPERIORITY_OR_OTHER||CMH adjusted difference|29.2||||0.0001|TWO_SIDED|95.0|14.4|44.0||No adjustment on P value, since this test was only conducted formally under the primary efficacy evaluation was significant.|Cochran-Mantel-Haenszel||A two-sided Cochran-Mantel-Haenszel method at level 5% weight-adjusted by country (country designations) was used to conduct the superiority test.|Null hypothesis of difference of Eylea minus Sham of 0 was tested.||44.0|14.4|0.0001
74072554|NCT01249664|147697597|SUPERIORITY_OR_OTHER||Difference in least square means|13.1|||<|0.0001|TWO_SIDED|95.0|9.4|16.7|||ANCOVA|||||16.7|9.4|<0.0001
74072555|NCT01249664|147697598|SUPERIORITY_OR_OTHER||CMH adjusted difference|50.5|||<|0.001|TWO_SIDED|95.0|35.0|66.0|||Cochran-Mantel-Haenszel|||||66.0|35.0|<0.001
74072556|NCT01249664|147697599|SUPERIORITY_OR_OTHER||CMH adjusted difference|64.0|||<|0.001|TWO_SIDED|95.0|47.8|80.3|||Cochran-Mantel-Haenszel|||||80.3|47.8|<0.001
74072557|NCT01249664|147697600|SUPERIORITY_OR_OTHER||CMH adjusted difference|21.0||||0.0308|TWO_SIDED|95.0|1.9|40.1|||Cochran-Mantel-Haenszel|||||40.1|1.9|0.0308
74072558|NCT01249664|147697601|SUPERIORITY_OR_OTHER||CMH adjusted difference|27.0||||0.0075|TWO_SIDED|95.0|7.2|46.8|||Cochran-Mantel-Haenszel|||||46.8|7.2|0.0075
74072559|NCT01249664|147697602|SUPERIORITY_OR_OTHER||CMH adjusted difference|42.7|||<|0.0001|TWO_SIDED|95.0|23.7|61.6|||Cochran-Mantel-Haenszel|||||61.6|23.7|<.0001
74072560|NCT01249664|147697603|SUPERIORITY_OR_OTHER||CMH adjusted difference|-6.5||||0.1478|TWO_SIDED|95.0|-15.2|2.3|||Cochran-Mantel-Haenszel|||||2.3|-15.2|0.1478
74072561|NCT01249664|147697604|SUPERIORITY_OR_OTHER||CMH adjusted difference|-25.8||||0.0006|TWO_SIDED|95.0|-40.6|-11.0|||Cochran-Mantel-Haenszel|||||-11.0|-40.6|0.0006
74072562|NCT01249664|147697605|SUPERIORITY_OR_OTHER||CMH adjusted difference|-32.2|||<|0.0001|TWO_SIDED|95.0|-48.1|-16.3|||Cochran-Mantel-Haenszel|||||-16.3|-48.1|<0.0001
74072563|NCT01249664|147697606|SUPERIORITY_OR_OTHER||CMH adjusted difference|-5.3||||0.2446|TWO_SIDED|95.0|-14.4|3.7|||Cochran-Mantel-Haenszel|||||3.7|-14.4|0.2446
74072564|NCT01249664|147697607|SUPERIORITY_OR_OTHER||CMH adjusted difference|-21.5||||0.0035|TWO_SIDED|95.0|-35.9|-7.0|||Cochran-Mantel-Haenszel|||||-7.0|-35.9|0.0035
74072565|NCT01249664|147697608|SUPERIORITY_OR_OTHER||CMH adjusted difference|-25.7||||0.0012|TWO_SIDED|95.0|-41.3|-10.1|||Cochran-Mantel-Haenszel|||||-10.1|-41.3|0.0012
74072566|NCT01249664|147697609|SUPERIORITY_OR_OTHER||Difference in least square means|-77.9|||<|0.0001|TWO_SIDED|95.0|-108.9|-46.9|||ANCOVA|||||-46.9|-108.9|<0.0001
74072567|NCT01249664|147697610|SUPERIORITY_OR_OTHER||Difference in least square means|-29.3||||0.065|TWO_SIDED|95.0|-60.4|1.8|||ANCOVA|||||1.8|-60.4|0.0650
74072568|NCT01249664|147697611|SUPERIORITY_OR_OTHER||Difference in least square means|-0.4808|||<|0.0001|TWO_SIDED|95.0|-0.599|-0.3626|||ANCOVA|||||-0.3626|-0.5990|<0.0001
74072569|NCT01249664|147697612|SUPERIORITY_OR_OTHER||Difference in least square means|-0.1346||||0.0256|TWO_SIDED|95.0|-0.2525|-0.0167|||ANCOVA|||||-0.0167|-0.2525|0.0256
74072570|NCT01249664|147697613|SUPERIORITY_OR_OTHER||Difference in least square means|-0.0045||||0.869|TWO_SIDED|95.0|-0.0579|0.049|||ANCOVA|||||0.0490|-0.0579|0.8690
74072571|NCT01249664|147697614|SUPERIORITY_OR_OTHER||Difference of least square means|5.21||||0.0104|TWO_SIDED|95.0|1.25|9.18|||ANCOVA|||||9.18|1.25|0.0104
74072572|NCT01249664|147697616|SUPERIORITY_OR_OTHER||Difference in least square means|-0.6648|||<|0.0001|TWO_SIDED|95.0|-0.8056|-0.5239|||ANCOVA|||||-0.5239|-0.8056|<0.0001
74072573|NCT01682083|147697635|SUPERIORITY|Hazard ratio is obtained from the stratified Pike estimator. A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.47|||<|0.0001|TWO_SIDED|95.0|0.39|0.58|||Log Rank|||The null hypothesis, H0: λ = 1 or reject it in favor of the alternative hypothesis, HA: λ ≠ 1, where λ is the hazard ratio (HR) of combination therapy relative to placebo.||0.58|0.39|< 0.0001
74072574|NCT01682083|147697636|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with dabrafenib + trametinib compared with Placebo.|Hazard Ratio, log|0.57||||0.006|TWO_SIDED|95.0|0.42|0.79|||Log Rank|the two-sided threshold for significance at this first interim analysis was p=0.000019||Hazard ratio is obtained from the stratified Pike estimator.||0.79|0.42|0.006
74072575|NCT01682083|147697637|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.51|||||TWO_SIDED|95.0|0.4|0.65||||||Hazard ratio is estimated using Pike estimator.||0.65|0.40|
74072576|NCT01682083|147697638|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.39|0.57||||||Hazard ratio is estimated using Pike estimator.||0.57|0.39|
74072577|NCT01239121|147697649|SUPERIORITY_OR_OTHER||Slope|0.6||||0.175|TWO_SIDED|95.0|-0.27|1.5|||Regression, Linear|||||1.5|-0.27|0.175
74072578|NCT01239121|147697650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.964|TWO_SIDED|95.0|0.49|2.1|||Regression, Logistic|||||2.1|.49|0.964
74072579|NCT04276883|147697652|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73883867|NCT00537394|147301420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin defined as 15 percentage points. If the confidence interval for the difference in regimen failure between omitting versus adding NRTIs was fully below 15 percentage points, then omitting NRTIs would be concluded to be not inferior to adding NRTIs for this outcome.|Risk Difference (RD)|3.2|||||TWO_SIDED|95.0|-6.1|12.5|||||Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and stratum. Differences in week 48 failure proportions by treatment calculated weighted by the inverse of the variance in each stratum.|Null Hypothesis was that omitting NRTIs is inferior to adding NRTIs for the outcome of regimen failure through 48 weeks.||12.5|-6.1|
73883868|NCT01377584|147301441|OTHER||Effect size|-0.51|||||TWO_SIDED|||||||||||||
73883869|NCT01377584|147301441|OTHER||Effect size|-0.42|||||TWO_SIDED|||||||||||||
73883870|NCT01377584|147301441|OTHER||Effect size|-0.82|||||TWO_SIDED|||||||||||||
73883871|NCT01377584|147301441|OTHER||Effect size|-1.31|||||TWO_SIDED|||||||||||||
74072580|NCT04276883|147697652|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
74072581|NCT04276883|147697653|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 120 minutes post-dose||||<0.0001
73883872|NCT01377584|147301441|OTHER||Effect size|-0.08|||||TWO_SIDED|||||||||||||
73883873|NCT01377584|147301441|OTHER||Effect size|-0.77|||||TWO_SIDED|||||||||||||
74072582|NCT04276883|147697653|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 120 minutes post-dose||||<0.0001
74072583|NCT04276883|147697653|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
74072584|NCT04276883|147697653|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
74072585|NCT04276883|147697653|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
74072586|NCT04276883|147697653|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
74072587|NCT04276883|147697653|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
74072588|NCT04276883|147697653|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
74072589|NCT04276883|147697653|SUPERIORITY|||||||0.0006|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 30 minutes post-dose||||0.0006
74072590|NCT04276883|147697653|SUPERIORITY|||||||0.0028|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 30 minutes post-dose||||0.0028
74072591|NCT04276883|147697653|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 20 minutes post-dose||||0.0070
74072592|NCT04276883|147697653|SUPERIORITY|||||||0.0092|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 20 minutes post-dose||||0.0092
74072593|NCT00659607|147697670|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test for paired observations|||||||<0.0001
74072594|NCT00659607|147697671|SUPERIORITY_OR_OTHER|||||||0.2669|||||||Chi-squared|||||||0.2669
74072595|NCT00659607|147697672|SUPERIORITY_OR_OTHER|||||||0.9674|||||||Chi-squared|||||||0.9674
74072596|NCT00659607|147697673|SUPERIORITY_OR_OTHER|||||||0.9207|||||||Chi-squared|||||||0.9207
74072597|NCT00659607|147697674|SUPERIORITY_OR_OTHER|||||||0.8249|||||||Fisher Exact|||||||0.8249
74072598|NCT00659607|147697675|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test for paired observations|||||||<0.0001
74072599|NCT00659607|147697677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0003|TWO_SIDED|95.0|1.121|4.151|||Chi-squared||The estimation of Odds Ratio and 95% Confidence Interval based on the logistic regression analysis|||4.151|1.121|0.0003
74072600|NCT00659607|147697678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.0001|TWO_SIDED|95.0|1.642|6.776|||Chi-squared||The Estimation of Odds Ratio and 95% Confidence Interval based the logistic regression analysis|||6.776|1.642|<0.0001
74072601|NCT00659607|147697679|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Chi-squared|||||||0.0075
74072602|NCT00659607|147697680|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Chi-squared|||||||0.0007
74072603|NCT00659607|147697681|SUPERIORITY_OR_OTHER|||||||0.0393|||||||Chi-squared|||||||0.0393
74072604|NCT00659607|147697682|SUPERIORITY_OR_OTHER|||||||0.0245|||||||Chi-squared|||||||0.0245
74072605|NCT03130699|147697729|SUPERIORITY|||||||0.95|||||||Regression, Logistic|||Analyses controlled for age, gender, employment and language.||||0.95
74072606|NCT03130699|147697730|SUPERIORITY|||||||0.37|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.37
74072607|NCT03130699|147697731|SUPERIORITY|||||||0.26|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.26
74072608|NCT03130699|147697732|SUPERIORITY|||||||0.9|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.90
74072609|NCT03130699|147697733|SUPERIORITY|||||||0.21|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.21
74072610|NCT03130699|147697734|SUPERIORITY|||||||0.3|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.30
74072611|NCT03130699|147697735|SUPERIORITY|||||||0.9|||||||Regression, Logistic|||Analyses controlled for income.||||0.90
74072612|NCT03130699|147697736|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||Analyses controlled for income.||||0.72
74072613|NCT03130699|147697737|SUPERIORITY|||||||0.61|||||||Regression, Logistic|||Analyses controlled for income.||||0.61
74072614|NCT03130699|147697738|SUPERIORITY|||||||0.49|||||||Regression, Logistic|||Analyses controlled for income.||||0.49
74072615|NCT03130699|147697739|SUPERIORITY|||||||0.96|||||||Regression, Logistic|||Analyses controlled for income.||||0.96
74072616|NCT03130699|147697740|SUPERIORITY|||||||0.64|||||||Regression, Logistic|||Analyses controlled for income.||||0.64
73883874|NCT01377584|147301442|OTHER||Effect size|0.51|||||TWO_SIDED|||||||||||||
74072617|NCT03130699|147697741|SUPERIORITY|||||||0.87|||||||Regression, Logistic|||Binary logistic analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.87
74072618|NCT03130699|147697742|SUPERIORITY|||||||0.58|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.58
74072619|NCT03130699|147697743|SUPERIORITY|||||||0.25|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.25
74072620|NCT03130699|147697744|SUPERIORITY|||||||0.11|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.11
74072621|NCT03130699|147697745|SUPERIORITY|||||||0.76|||||||Regression, Logistic|||Analyses controlled for income.||||0.76
74072622|NCT03130699|147697746|SUPERIORITY|||||||0.05|||||||Regression, Logistic|||Analyses controlled for income.||||0.05
74072623|NCT03130699|147697747|SUPERIORITY|||||||0.63|||||||Regression, Logistic|||Analyses controlled for income.||||0.63
74072624|NCT03130699|147697748|SUPERIORITY|||||||0.63|||||||Regression, Logistic|||Analyses is controlled for income.||||0.63
74072625|NCT03130699|147697749|SUPERIORITY|||||||0.002|||||||Regression, Logistic|||Analyses controlled for income.||||0.002
74072626|NCT03130699|147697750|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||Analyses controlled for income.||||0.008
74072627|NCT01199861|147697755|SUPERIORITY_OR_OTHER||Percent Inhibition|41.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
74072628|NCT01199861|147697755|SUPERIORITY_OR_OTHER||Percent Inhibition|-35.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
74072629|NCT01199861|147697755|SUPERIORITY_OR_OTHER||Percent Inhibition|44.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
74072630|NCT01199861|147697756|SUPERIORITY_OR_OTHER||Percent Inhibition|38.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
74072631|NCT01199861|147697756|SUPERIORITY_OR_OTHER||Percent Inhibition|-28.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
74072632|NCT01199861|147697756|SUPERIORITY_OR_OTHER||Percent Inhibition|48.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
74072633|NCT00669864|147697785|SUPERIORITY_OR_OTHER||Estimated mean|-1.303|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-1.414|-1.192||A significant mean HbA1c decrease was to be declared if H0 is rejected at a significance level of 2.5%.|t-test, 1 sided|||The null hypothesis (H0): HbA1c after 16 weeks - HbA1c at baseline ≥ 0% against the alternative hypothesis (H1): HbA1c after 16 weeks - HbA1c at baseline \< 0%. If H0 rejected at a significance level of 2.5%, declare a significant mean HbA1c decrease||-1.192|-1.414|<0.0001
74072634|NCT01822548|147697805|OTHER||||||<|0.05|||||||Regression, Linear|Generalized linear model (GLM)||||||<0.05
74072635|NCT01822548|147697805|SUPERIORITY||Slope|0.362|||<|0.05|TWO_SIDED|95.0|0.028|0.695|||ANOVA|adjustment for baseline value of EPC||||0.695|0.028|<0.05
74072636|NCT01822548|147697806|SUPERIORITY||Slope|-0.067|||<|0.05|TWO_SIDED|95.0|-0.358|0.224|||ANOVA|||||0.224|-0.358|<0.05
74072637|NCT02809183|147697808|OTHER|Single-group test|Group LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.5547|TWO_SIDED|95.0|-0.9|0.5||The null hypothesis is that the mean change from baseline within the Pooled Placebo treatment group = 0 mEq/L.|Mixed Models Analysis|||||0.5|-0.9|0.5547
74072638|NCT02809183|147697808|OTHER|Single-group test|Group LS mean|3.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.4|4.0||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID group = 0 mEq/L|Mixed Models Analysis|||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID treatment group = 0 mEq/L.||4.0|2.4|< 0.0001
74072639|NCT02809183|147697808|OTHER|Single-group test|Group LS mean|3.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.2|3.8||The null hypothesis is the 3g TRC101 BID treatment group mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||3.8|2.2|< 0.0001
74072640|NCT02809183|147697808|OTHER|Single-group test|Group LS mean|3.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.9|4.5||The null hypothesis is the 4.5g TRC101 BID treatment group mean change from baseline = 0 mEq/L|Mixed Models Analysis|||||4.5|2.9|< 0.0001
74072641|NCT02809183|147697809|OTHER|Two-group test|Difference between group LS means|3.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.3|4.5||The null hypothesis is the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.5|2.3|< 0.0001
74072642|NCT02809183|147697809|OTHER|Two-group test|Difference between group LS means|3.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.2|4.3||The null hypothesis is the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.3|2.2|< 0.0001
74072643|NCT02809183|147697809|OTHER|Two-group test|Difference between group LS means|3.9|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.9|5.0||The null hypothesis is the difference between the treatment groups (4.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||5.0|2.9|< 0.0001
74072644|NCT02809183|147697810|OTHER|Single-group test|Group LS mean|3.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|3.0|3.7||The null hypothesis is that the mean change from baseline within the Combined TRC101 treatment group = 0 mEq/L.|Mixed Models Analysis|||||3.7|3.0|< 0.0001
74072645|NCT02809183|147697811|OTHER|Two-group test|Difference between group LS means|3.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.8|4.4||The null hypothesis is that the difference between treatment groups (Combined TRC101 - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.4|2.8|< 0.0001
74072646|NCT02809183|147697812|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
73883875|NCT01377584|147301442|OTHER||Effect size|0.41|||||TWO_SIDED|||||||||||||
74072647|NCT02809183|147697812|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||< 0.0001
74072648|NCT02809183|147697812|OTHER|Two-group test||||||0.0074||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0074
74072649|NCT02809183|147697812|OTHER|Two-group test||||||0.0012||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||0.0012
74072650|NCT02809183|147697812|OTHER|Two-group test||||||0.0032||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||0.0032
73883876|NCT01377584|147301442|OTHER||Effect size|0.57|||||TWO_SIDED|||||||||||||
73883877|NCT01377584|147301442|OTHER||Effect size|1.54|||||TWO_SIDED|||||||||||||
73883878|NCT01377584|147301442|OTHER||Effect size|0.0|||||TWO_SIDED|||||||||||||
73883879|NCT01377584|147301442|OTHER||Effect size|0.65|||||TWO_SIDED|||||||||||||
73883880|NCT01377584|147301443|OTHER||Effect size|-1.01|||||TWO_SIDED|||||||||||||
73883881|NCT01377584|147301443|OTHER||Effect size|-0.94|||||TWO_SIDED|||||||||||||
74072651|NCT02809183|147697812|OTHER|Two-group test||||||0.0013||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0013
74072652|NCT02809183|147697812|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
74072653|NCT02809183|147697812|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||< 0.0001
74072654|NCT02809183|147697812|OTHER|Two-group test|||||<|0.0006||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||< 0.0006
74072655|NCT02809183|147697813|OTHER|Single-group test|Group LS mean|3.5|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.7|4.2||The null hypothesis is that the mean change from baseline within the 6g TRC101 QD group = 0 mEq/L.|Mixed Models Analysis|||||4.2|2.7|<0.0001
74072656|NCT02809183|147697814|OTHER|Two-group test|Difference between group LS means|3.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.6|4.7||The null hypothesis is the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.7|2.6|<0.0001
74072657|NCT02809183|147697815|OTHER|Two-group test|Difference between group LS means|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.4214|TWO_SIDED|95.0|-1.6|0.7||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - 6g TRC101 QD) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||0.7|-1.6|0.4214
74072658|NCT02809183|147697816|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
73883882|NCT01377584|147301443|OTHER||Effect size|-0.4|||||TWO_SIDED|||||||||||||
73883883|NCT01377584|147301443|OTHER||Effect size|-0.31|||||TWO_SIDED|||||||||||||
73883884|NCT01377584|147301443|OTHER||Effect size|-0.65|||||TWO_SIDED|||||||||||||
73883885|NCT01377584|147301443|OTHER||Effect size|-0.77|||||TWO_SIDED|||||||||||||
74072659|NCT02809183|147697816|OTHER|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||0.0003
73883886|NCT01377584|147301444|OTHER||Effect size|0.52|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
74072660|NCT02809183|147697816|OTHER|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0003
74072661|NCT02545998|147697817|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.510
74072662|NCT02545998|147697818|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
74072663|NCT02545998|147697819|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74072664|NCT02545998|147697820|SUPERIORITY|||||||0.589|||||||Wilcoxon (Mann-Whitney)|||||||0.589
74072665|NCT02545998|147697821|SUPERIORITY|||||||0.471|||||||Wilcoxon (Mann-Whitney)|||||||0.471
74072666|NCT02545998|147697822|SUPERIORITY|||||||0.264|||||||Sign test|||||||0.264
74072667|NCT01430741|147697836|SUPERIORITY_OR_OTHER||||||=|0.04|||||||Mixed Models Analysis|||Compared changes in service intensity among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.04
74072668|NCT01430741|147697837|SUPERIORITY_OR_OTHER||||||=|0.21|||||||Mixed Models Analysis|||Compared changes in alcohol dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.21
73883887|NCT01377584|147301444|OTHER||Effect size|-0.63|||||TWO_SIDED||||||||Comparing 1 month and 3 months|||||
74072669|NCT01430741|147697837|SUPERIORITY_OR_OTHER||||||=|0.07|||||||Mixed Models Analysis|||Compared changes in drug dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.07
74072670|NCT01430741|147697838|SUPERIORITY_OR_OTHER||||||=|0.14|||||||Mixed Models Analysis|||Compared mental health inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.14
73883888|NCT01377584|147301444|OTHER||Effect size|0.5|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
73883889|NCT01377584|147301444|OTHER||Effect size|-0.63|||||TWO_SIDED||||||||Comparing 1 month to 3 months|||||
73883890|NCT01377584|147301444|OTHER||Effect size|-0.92|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
73883891|NCT01377584|147301444|OTHER||Effect size|-0.26|||||TWO_SIDED||||||||Comparing 1 month to 3 months|||||
73888347|NCT02683577|147309563|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.462|||||TWO_SIDED|90.0|1.579|3.837|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.||3.837|1.579|
74072671|NCT01430741|147697838|SUPERIORITY_OR_OTHER||||||=|0.19|||||||Mixed Models Analysis|||Compared medical inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.19
74072672|NCT01430741|147697839|SUPERIORITY_OR_OTHER||||||=|0.24|||||||Mixed Models Analysis|||Compared changes in mental health emergency department visits among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.24
74072673|NCT01430741|147697840|SUPERIORITY_OR_OTHER||||||=|0.481|||||||Regression, Cox|||We used Kaplan-Meier survival curves to estimate the extent and timing of negative housing exits over time and Cox proportional hazards regression to assess the relationship between membership in the GTO group and risk of experiencing a negative housing exit, adjusting for a set of relevant covariates.||||=.481
74072674|NCT03900624|147697859|SUPERIORITY|||||||0.632|||||||Wilcoxon (Mann-Whitney)|||||||0.632
74072675|NCT03900624|147697860|SUPERIORITY|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||||||0.725
74072676|NCT03900624|147697861|SUPERIORITY|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||||||0.725
74072677|NCT01494506|147697883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9416|TWO_SIDED|95.0|0.77|1.28|||Log Rank|Unstratified logrank test.||||1.28|0.77|0.9416
74072678|NCT01494506|147697883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.012|TWO_SIDED|95.0|0.49|0.92|||Log Rank|Unstratified logrank test.||||0.92|0.49|0.012
74072679|NCT01494506|147697884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.1|TWO_SIDED|95.0|0.63|1.04|||Log Rank|||||1.04|0.63|0.100
74072680|NCT01494506|147697884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56|||<|0.001|TWO_SIDED|95.0|0.41|0.75|||Log Rank|||||0.75|0.41|<0.001
74072681|NCT01494506|147697885|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0264||||0.214|TWO_SIDED|95.0|-0.005|0.058|||Fisher Exact|||||0.058|-0.005|0.214
74072682|NCT01494506|147697885|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.069||||0.01|TWO_SIDED|95.0|0.018|0.12|||Fisher Exact|||||0.120|0.018|0.010
74072683|NCT01494506|147697886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.1008|TWO_SIDED|95.0|0.65|1.03|||Log Rank|Unstratified log rank test.||||1.03|0.65|0.1008
74072684|NCT01494506|147697886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.0002|TWO_SIDED|95.0|0.45|0.78|||Log Rank|Unstratified log rank test||||0.78|0.45|0.0002
74072685|NCT01494506|147697887|SUPERIORITY_OR_OTHER|||||||0.82|||||||Fisher Exact|||||||0.82
74072686|NCT01494506|147697887|SUPERIORITY_OR_OTHER|||||||0.8|||||||Fisher Exact|||||||0.80
74072687|NCT01494506|147697888|SUPERIORITY_OR_OTHER|||||||0.024|||||||Fisher Exact|||||||0.024
74072688|NCT01494506|147697888|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
74072689|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status||||0.6388
74072690|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.8445||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status||||0.8445
74072691|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning||||0.6388
74072692|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.9435||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning||||0.9435
74072693|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning||||0.2654
74072694|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning||||0.7674
74072695|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning||||0.1628
74072696|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning||||0.6712
74072697|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.7738||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning||||0.7738
74072698|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning||||0.6712
74072699|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.3408||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning||||0.3408
74072700|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning||||0.6712
74072701|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6766||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue||||0.6766
74072702|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue||||0.6712
74072703|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting||||0.6388
74072704|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting||||0.7674
74072705|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.4993||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain||||0.4993
74072706|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain||||0.6712
74072707|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea||||0.2654
73883892|NCT00795535|147301454|SUPERIORITY_OR_OTHER||||||<|0.15|TWO_SIDED|||||To avoid overfitting the models, only predictors with p\<0.15 were included in the final models.|Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to compare continuous predictors, whereas chi-square tests were used to compare dichotomized predictors between those with and without serious injury. Test characteristics (specificity and positive/negative predictive values) of continuous predictors were reported based on threshold values chosen for a minimum of 80% of sensitivity. Multiple logistic regression models were used to examine the marginal effect of each predictor.||||< 0.15
74072708|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea||||0.6712
74072709|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Insomnia||||0.7617
74072710|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6712|||||||Cochran-Mantel-Haenszel|||Comparison of Insomnia||||0.6712
74072711|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.9123||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss||||0.9123
74072712|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss||||0.6712
73888348|NCT02683577|147309564|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|1|TWO_SIDED|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the mild HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||0.000|0.000|=1.0000
74072713|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation||||0.7617
74072714|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation||||0.6712
74072715|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea||||0.1628
74072716|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea||||0.6712
74072717|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties||||0.6388
74072718|NCT01494506|147697889|SUPERIORITY_OR_OTHER|||||||0.7308||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties||||0.7308
74072719|NCT02753842|147697891|SUPERIORITY||Mean Difference (Final Values)|1.39|||<|0.05|TWO_SIDED|95.0|0.52|2.26||The a priori threshold was p\<0.05.|Mixed Models Analysis|||Comparing fitted to standard condoms, the null hypothesis was no difference in pleasure.||2.26|0.52|<0.05
73888349|NCT02683577|147309564|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|1|TWO_SIDED|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the moderate HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||0.000|0.000|=1.0000
74072720|NCT02753842|147697892|SUPERIORITY||Odds Ratio (OR)|1.13|||>|0.05|TWO_SIDED|95.0|0.92|1.38|||Mixed Models Analysis|||A single item assessed whether participants preferred fitted condoms or standard condoms at the end of the study (the item word viewed by participants used the blinded identifiers of each condom type).||1.38|0.92|>0.05
74072721|NCT02753842|147697894|SUPERIORITY||Odds Ratio (OR)|0.93|||>|0.05|TWO_SIDED|95.0|0.27|3.24|||logistic mixed effects model|||We assessed clinical condom failure for anal sex, comparing anal sex acts with fitted condoms to anal sex acts with standard condoms.||3.24|0.27|>0.05
74072722|NCT02753842|147697895|SUPERIORITY||Median Difference (Final Values)|1.06|||<|0.05|TWO_SIDED|95.0|0.18|1.94||The a priori threshold was p\<0.05.|Mixed Models Analysis|||Comparing thin to standard condoms, the null hypothesis was no difference in pleasure.||1.94|0.18|<0.05
74072723|NCT05216081|147697897|OTHER||Percentage of enrolled from eligible|69.4|||||TWO_SIDED|95.0|61.5|76.2||||||||76.2|61.5|
74072724|NCT05216081|147697898|OTHER||Percentage of enrolled from eligible|99.0|||||TWO_SIDED|95.0|94.7|99.8||||||||99.8|94.7|
74072725|NCT05216081|147697900|OTHER||Percentage screened positive for EM|15.8|||||TWO_SIDED|95.0|10.0|24.2||||||||24.2|10|
74072726|NCT05216081|147697903|OTHER||Percentage who self-disclosed|57.1|||||TWO_SIDED|95.0|32.6|78.6||||||||78.6|32.6|
74072727|NCT05216081|147697904|OTHER||Percentage substantiated by socialworker|75.0|||||TWO_SIDED|95.0|50.5|89.8||||||||89.8|50.5|
74072728|NCT00234078|147697905|SUPERIORITY_OR_OTHER|||||||0.385||||||versus placebo|t-test, 2 sided|a general linear model||||||0.385
74072729|NCT00234078|147697906|SUPERIORITY_OR_OTHER|||||||0.601||||||versus placebo|t-test, 2 sided|a general linear model||||||0.601
74072730|NCT00234078|147697907|SUPERIORITY_OR_OTHER|||||||0.084||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.084
74072731|NCT00234078|147697907|SUPERIORITY_OR_OTHER|||||||0.02||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.020
74072732|NCT00234078|147697907|SUPERIORITY_OR_OTHER|||||||0.421||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.421
74072733|NCT00234078|147697908|SUPERIORITY_OR_OTHER|||||||0.087||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.087
74072734|NCT00234078|147697908|SUPERIORITY_OR_OTHER|||||||0.004||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.004
74072735|NCT00234078|147697908|SUPERIORITY_OR_OTHER|||||||0.029||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.029
74072736|NCT03471078|147697909|OTHER|The primary efficacy endpoint was tested between avatrombopag and placebo using the Cochran-Mantel-Haenszel 2-sided test at α=0.05, adjusting for the number of eligible chemotherapy agents as collected in IWRS (1 or ≥2 permissible chemotherapy agents).|Mean Difference (Final Values)|-3.0||||0.7186|TWO_SIDED|95.0|-21.7|15.6|||Cochran-Mantel-Haenszel|||||15.6|-21.7|0.7186
74072737|NCT03471078|147697910|OTHER|||||||0.8372|||||||Van Elteren Test|||||||0.8372
74072738|NCT02777528|147697941|OTHER|Performance goal tested using Exact method calculation to estimate the 95% one-sided lower confidence level (95% LCL) on the proportion of participants with primary endpoint success. If the 95% LCL exceeded 0.60, then the null hypothesis was to be rejected and the PG was met.|95% Exact Lower Confidence Limit|0.745|||||TWO_SIDED|||||||||"Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 1-Month imaging performed.~Results were tested against a performance goal (PG) of 0.60 (i.e. 60%), derived from outcomes from a systematic review of hybrid TEVAR repair literature.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 50 patients."||||
74072739|NCT02937701|147697954|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.37|||||TWO_SIDED|90.0|2.67|15.96||||||For the primary analysis of ACR20, the response difference (RD) was estimated by the Mantel-Haenszel (MH) estimate and the 90% confidence intervals (CIs) of RD were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use for RA).||15.96|2.67|
74072740|NCT02937701|147697954|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.3|||||TWO_SIDED|90.0|2.67|15.92|||||Response Difference is based on a generalized linear model with actual stratification variables (geographic region and prior biologic use for RA) as covariates in the model.|A sensitivity analysis with the RD estimate and CIs for RD of ACR20 estimated using a generalized linear model with geographic region and prior biologic use for RA as covariates was also conducted.||15.92|2.67|
73888350|NCT02683577|147309565|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.294|||||TWO_SIDED|90.0|1.144|4.598|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for AUC(0-tlast) values for telotristat ethyl.||4.598|1.144|
74072741|NCT02937701|147697954|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|7.184|||||TWO_SIDED|90.0|0.748|13.62|||||The ACR core set includes tender joint count, swollen joint count, subject's global health assessment, investigator's global health assessment, subject's assessment of disease related pain, HAQ-DI, and CRP.|A post-hoc analysis was conducted to adjust for the impact of random imbalance in baseline demographic and disease characteristics between the 2 treatment groups. The MH estimate of RD and corresponding CIs were estimated using a nonparametric analysis of covariance method with stratification factors geographic region and prior biologic use, and adjustment for baseline covariates (ACR core set, age, use of oral corticosteroid, use of NSAID, body mass index categories, and methotrexate dose).||13.620|0.748|
74072742|NCT02937701|147697955|OTHER||Response Difference|8.03|||||TWO_SIDED|90.0|1.15|14.81||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||14.81|1.15|
74072743|NCT02937701|147697955|OTHER||Response Difference|4.96|||||TWO_SIDED|90.0|-1.8|11.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.64|-1.80|
74072744|NCT02937701|147697955|OTHER||Response Difference|9.37|||||TWO_SIDED|90.0|-0.51|12.87||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||12.87|-0.51|
74072745|NCT02937701|147697956|OTHER||Response Difference|3.05|||||TWO_SIDED|90.0|-5.26|11.73||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.73|-5.26|
73888351|NCT02683577|147309565|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.168|||||TWO_SIDED|90.0|1.715|5.852|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for telotristat ethyl.||5.852|1.715|
73883893|NCT02485691|147301461|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.73||P-value from 2-sided stratified log-rank test, stratified for ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization. Significance threshold was at 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.73|0.40|<0.0001
73883894|NCT02485691|147301462|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.64||||0.0078|TWO_SIDED|95.0|0.46|0.89||P-value from two-sided stratified log-rank test, stratified for ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.89|0.46|0.0078
73883895|NCT02485691|147301463|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68||P-value from two-sided stratified log-rank test, stratified for ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.68|0.40|<0.0001
73883896|NCT02485691|147301464|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.||||||0.0003||||||Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Cochran-Mantel-Haenszel|||||||0.0003
73883897|NCT02485691|147301465|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.||||||0.0004||||||Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Cochran-Mantel-Haenszel|||||||0.0004
74072746|NCT02937701|147697956|OTHER||Response Difference|8.5|||||TWO_SIDED|90.0|-1.18|17.97||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.97|-1.18|
74072747|NCT02937701|147697956|OTHER||Response Difference|3.31|||||TWO_SIDED|90.0|-4.61|11.7||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.70|-4.61|
73883898|NCT03413891|147301485|SUPERIORITY||Risk Ratio (RR)|0.93|||=|0.72|TWO_SIDED|95.0|0.6|1.42|||Chi-squared|||||1.42|0.60|=0.72
73883899|NCT03413891|147301487|SUPERIORITY||Rate Ratio|0.76|||=|0.36|TWO_SIDED|95.0|0.42|1.37|||negative-binomial regression|||||1.37|0.42|=0.36
73883900|NCT03413891|147301488|SUPERIORITY||Rate Ratio|0.32|||=|0.03|TWO_SIDED|95.0|0.12|0.89|||negative-binomial regression|||||0.89|0.12|=0.03
73883901|NCT03413891|147301489|SUPERIORITY||Rate Ratio|0.6|||=|0.11|TWO_SIDED|95.0|0.32|1.12|||negative-binomial regression|||||1.12|0.32|=0.11
73883902|NCT03413891|147301490|SUPERIORITY||Rate Ratio|0.42|||=|0.15|TWO_SIDED|95.0|0.13|1.38|||negative-binomial regression|||||1.38|0.13|=0.15
73883903|NCT03413891|147301492|SUPERIORITY||Rate Ratio|0.57|||=|0.37|TWO_SIDED|95.0|0.17|1.91|||negative-binomial regression|||||1.91|0.17|=0.37
74072748|NCT02937701|147697956|OTHER||Response Difference|4.06|||||TWO_SIDED|90.0|-5.4|13.4||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.40|-5.40|
74072749|NCT02937701|147697956|OTHER||Response Difference|0.82|||||TWO_SIDED|90.0|-7.34|9.4||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.40|-7.34|
74072750|NCT02937701|147697956|OTHER||Response Difference|2.79|||||TWO_SIDED|90.0|-6.86|12.34||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||12.34|-6.86|
74072751|NCT02937701|147697956|OTHER||Response Difference|-3.74|||||TWO_SIDED|90.0|-12.27|5.17||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||5.17|-12.27|
74072752|NCT02937701|147697956|OTHER||Response Difference|1.12|||||TWO_SIDED|90.0|-8.89|11.08||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.08|-8.89|
73883904|NCT03413891|147301493|SUPERIORITY||Risk Ratio (RR)|0.7|||=|0.66|TWO_SIDED|95.0|0.26|1.91|||Chi-squared|||||1.91|0.26|=0.66
73883905|NCT03413891|147301494|SUPERIORITY||Rate Ratio|0.4|||=|0.04|TWO_SIDED|95.0|0.16|0.98|||negative-binomial regression|||||0.98|0.16|=0.04
73883906|NCT03413891|147301495|SUPERIORITY||Rate Ratio|0.37|||<|0.01|TWO_SIDED|95.0|0.18|0.78|||negative-binomial regression|||||0.78|0.18|<0.01
73883907|NCT04905134|147301521|OTHER|||||||0.04|||||||Fisher Exact|||Flexible scope compared with the SOC scope||||0.04
73883908|NCT05546476|147301572|SUPERIORITY||Difference in Posterior Median|1.33|||||TWO_SIDED|90.0|0.49|2.34||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||2.34|0.49|
73883909|NCT05546476|147301572|SUPERIORITY||Difference in Posterior Median|2.08|||||TWO_SIDED|90.0|1.08|3.15||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||3.15|1.08|
73883910|NCT05546476|147301572|SUPERIORITY||Difference in Posterior Median|3.0|||||TWO_SIDED|90.0|1.68|4.34||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||4.34|1.68|
73883911|NCT05546476|147301573|SUPERIORITY||Difference in LS Mean|53.36|||=|0.826|TWO_SIDED|90.0|-40.89|147.6|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||147.60|-40.89|=0.8260
73883912|NCT05546476|147301573|SUPERIORITY||Difference in LS Mean|-37.9|||=|0.254|TWO_SIDED|90.0|-132.94|57.14|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||57.14|-132.94|=0.2540
73883913|NCT05546476|147301573|SUPERIORITY||Difference in LS Mean|-1.95|||=|0.487|TWO_SIDED|90.0|-101.63|97.73|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||97.73|-101.63|=0.4870
74072753|NCT02937701|147697956|OTHER||Response Difference|-5.25|||||TWO_SIDED|90.0|-13.24|3.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||3.29|-13.24|
74072754|NCT02937701|147697956|OTHER||Response Difference|-1.49|||||TWO_SIDED|90.0|-11.01|8.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||8.04|-11.01|
73883914|NCT05546476|147301573|SUPERIORITY||Difference in LS Mean|37.76|||=|0.0497|TWO_SIDED|90.0|0.07|75.46|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||75.46|0.07|=0.0497
73883915|NCT05546476|147301573|SUPERIORITY||Difference in LS Mean|-4.36|||=|0.5745|TWO_SIDED|90.0|-42.94|34.22|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||34.22|-42.94|=0.5745
73888352|NCT02683577|147309567|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|1.72|||||TWO_SIDED|90.0|1.11|2.65|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for LP-778902.||2.65|1.11|
73883916|NCT05546476|147301573|SUPERIORITY||Difference in LS Mean|49.85|||=|0.0189|TWO_SIDED|90.0|10.62|89.08|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||89.08|10.62|=0.0189
73883917|NCT05546476|147301573|SUPERIORITY||Difference in LS Mean|8.51|||=|0.1302|TWO_SIDED|90.0|-4.0|21.03|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||21.03|-4.00|=0.1302
73883918|NCT05546476|147301573|SUPERIORITY||Difference in LS Mean|4.49|||=|0.278|TWO_SIDED|90.0|-8.18|17.16|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||17.16|-8.18|=0.2780
73883919|NCT05546476|147301573|SUPERIORITY||Difference in LS Mean|8.11|||=|0.1529|TWO_SIDED|90.0|-5.01|21.23|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||21.23|-5.01|=0.1529
73883920|NCT05546476|147301574|SUPERIORITY||Difference in LS Mean|-130.27|||=|0.5762|TWO_SIDED|90.0|-1257.31|996.77|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||996.77|-1257.31|=0.5762
74072755|NCT02937701|147697957|OTHER||Response Difference|4.41|||||TWO_SIDED|90.0|-0.56|9.38||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.38|-0.56|
74072756|NCT02937701|147697957|OTHER||Response Difference|1.62|||||TWO_SIDED|90.0|-4.71|7.94||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.94|-4.71|
74072757|NCT02937701|147697957|OTHER||Response Difference|2.3|||||TWO_SIDED|90.0|-4.45|9.03||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.03|-4.45|
73883921|NCT05546476|147301574|SUPERIORITY||Difference in LS Mean|724.14|||=|0.1486|TWO_SIDED|90.0|-425.81|1874.09|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1874.09|-425.81|=0.1486
73883922|NCT05546476|147301574|SUPERIORITY||Difference in LS Mean|185.62|||=|0.3972|TWO_SIDED|90.0|-997.94|1369.18|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1369.18|-997.94|=0.3972
73883923|NCT05546476|147301575|SUPERIORITY||Difference in LS Mean|1587.26|||=|0.0985|TWO_SIDED|90.0|-443.79|3618.31|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3618.31|-443.79|=0.0985
73883924|NCT05546476|147301575|SUPERIORITY||Difference in LS Mean|-98.54|||=|0.5315|TWO_SIDED|90.0|-2169.67|1972.58|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1972.58|-2169.67|=0.5315
74072758|NCT02937701|147697957|OTHER||Response Difference|7.09|||||TWO_SIDED|90.0|0.27|13.83||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.83|0.27|
74072759|NCT02937701|147697958|OTHER||Response Difference|-1.33|||||TWO_SIDED|90.0|-10.4|7.62||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.62|-10.40|
73883925|NCT05546476|147301575|SUPERIORITY||Difference in LS Mean|2203.18|||=|0.0437|TWO_SIDED|90.0|84.51|4321.85|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||4321.85|84.51|=0.0437
73883926|NCT05546476|147301576|SUPERIORITY||Difference in LS Mean|0.0|||=|0.5052|TWO_SIDED|90.0|-0.046|0.045|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.045|-0.046|=0.5052
73883927|NCT05546476|147301576|SUPERIORITY||Difference in LS Mean|-0.004|||=|0.5599|TWO_SIDED|90.0|-0.05|0.042|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.042|-0.050|=0.5599
73883928|NCT05546476|147301576|SUPERIORITY||Difference in LS Mean|0.017|||=|0.277|TWO_SIDED|90.0|-0.03|0.064|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.064|-0.030|=0.2770
74072760|NCT02937701|147697958|OTHER||Response Difference|3.24|||||TWO_SIDED|90.0|-7.28|13.67||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.67|-7.28|
74072761|NCT02937701|147697958|OTHER||Response Difference|6.52|||||TWO_SIDED|90.0|-2.62|15.48||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||15.48|-2.62|
73883929|NCT05546476|147301576|SUPERIORITY||Difference in LS Mean|0.0|||=|0.5047|TWO_SIDED|90.0|-0.071|0.07|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.070|-0.071|=0.5047
73883930|NCT05546476|147301576|SUPERIORITY||Difference in LS Mean|-0.026|||=|0.7316|TWO_SIDED|90.0|-0.097|0.045|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.045|-0.097|=0.7316
73883931|NCT05546476|147301576|SUPERIORITY||Difference in LS Mean|0.01|||=|0.4145|TWO_SIDED|90.0|-0.063|0.082|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.082|-0.063|=0.4145
73883932|NCT05546476|147301577|SUPERIORITY||Difference in LS Mean|4.24|||=|0.0114|TWO_SIDED|90.0|1.19|7.28|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||7.28|1.19|=0.0114
74072762|NCT02937701|147697958|OTHER||Response Difference|10.74|||||TWO_SIDED|90.0|0.12|21.03||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||21.03|0.12|
73883933|NCT05546476|147301577|SUPERIORITY||Difference in LS Mean|0.64|||=|0.36|TWO_SIDED|90.0|-2.3|3.57|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.57|-2.30|=0.3600
74072763|NCT02937701|147697958|OTHER||Response Difference|0.56|||||TWO_SIDED|90.0|-8.54|9.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.59|-8.54|
73883934|NCT05546476|147301577|SUPERIORITY||Difference in LS Mean|4.11|||=|0.0138|TWO_SIDED|90.0|1.06|7.17|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||7.17|1.06|=0.0138
74072764|NCT02937701|147697958|OTHER||Response Difference|2.93|||||TWO_SIDED|90.0|-7.62|13.39||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.39|-7.62|
74072765|NCT02937701|147697958|OTHER||Response Difference|-1.04|||||TWO_SIDED|90.0|-10.11|7.93||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.93|-10.11|
74072766|NCT02937701|147697958|OTHER||Response Difference|6.14|||||TWO_SIDED|90.0|-4.44|16.54||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||16.54|-4.44|
74072767|NCT02937701|147697958|OTHER||Response Difference|-5.43|||||TWO_SIDED|90.0|-14.39|3.71||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||3.71|-14.39|
73883935|NCT05546476|147301578|SUPERIORITY||Difference in LS Mean|2.35|||=|0.009|TWO_SIDED|90.0|0.72|3.97|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.97|0.72|=0.0090
73883936|NCT05546476|147301578|SUPERIORITY||Difference in LS Mean|0.0|||=|0.4987|TWO_SIDED|90.0|-1.55|1.56|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.56|-1.55|=0.4987
74072768|NCT02937701|147697958|OTHER||Response Difference|2.98|||||TWO_SIDED|90.0|-7.51|13.37||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.37|-7.51|
74072769|NCT02937701|147697959|OTHER||Response Difference|-2.5|||||TWO_SIDED|90.0|-5.84|0.83||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||0.83|-5.84|
74072770|NCT02937701|147697959|OTHER||Response Difference|-2.43|||||TWO_SIDED|90.0|-7.47|2.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||2.64|-7.47|
74072771|NCT02937701|147697959|OTHER||Response Difference|5.46|||||TWO_SIDED|90.0|-0.01|10.91||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.91|-0.01|
74072772|NCT02937701|147697959|OTHER||Response Difference|4.58|||||TWO_SIDED|90.0|-1.21|10.34||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.34|-1.21|
74072773|NCT02937701|147697960|OTHER||Response Difference|0.2|||||TWO_SIDED|90.0|-8.12|8.02||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||8.02|-8.12|
74072774|NCT02937701|147697960|OTHER||Response Difference|-0.08|||||TWO_SIDED|90.0|-9.39|9.28||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.28|-9.39|
74072775|NCT02937701|147697960|OTHER||Response Difference|1.5|||||TWO_SIDED|90.0|-7.0|9.51||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.51|-7.00|
74072776|NCT02937701|147697960|OTHER||Response Difference|7.49|||||TWO_SIDED|90.0|-2.39|17.22||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.22|-2.39|
74072777|NCT02937701|147697960|OTHER||Response Difference|-0.5|||||TWO_SIDED|90.0|-9.03|7.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.59|-9.03|
74072778|NCT02937701|147697960|OTHER||Response Difference|3.39|||||TWO_SIDED|90.0|-6.41|13.14||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.14|-6.41|
74072779|NCT02937701|147697960|OTHER||Response Difference|-0.43|||||TWO_SIDED|90.0|-8.98|7.66||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.66|-8.98|
74072780|NCT02937701|147697960|OTHER||Response Difference|7.87|||||TWO_SIDED|90.0|-2.13|17.68||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.68|-2.13|
74072781|NCT02937701|147697960|OTHER||Response Difference|1.95|||||TWO_SIDED|90.0|-6.81|10.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.29|-6.81|
74072782|NCT02937701|147697960|OTHER||Response Difference|12.06|||||TWO_SIDED|90.0|1.74|22.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||22.04|1.74|
74072783|NCT02937701|147697961|OTHER||Mean Difference|-0.07|||||TWO_SIDED|90.0|-0.2|0.007||||||Week 2 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.007|-0.20|
74072784|NCT02937701|147697961|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.17|0.16||||||Week 6 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.16|-0.17|
74072785|NCT02937701|147697961|OTHER||Mean Difference|-0.04|||||TWO_SIDED|90.0|-0.21|0.14||||||Week 14 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.14|-0.21|
74072786|NCT02937701|147697961|OTHER||Mean Difference|-0.01|||||TWO_SIDED|90.0|-0.2|0.17||||||Week 22 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.17|-0.20|
74072787|NCT02937701|147697962|OTHER||Mean Difference|0.16|||||TWO_SIDED|90.0|-0.08|0.4||||||Week 30 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.40|-0.08|
74072788|NCT02937701|147697962|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.27|0.28||||||Week 30 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.28|-0.27|
74072789|NCT02937701|147697962|OTHER||Mean Difference|0.11|||||TWO_SIDED|90.0|-0.12|0.35||||||Week 34 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.35|-0.12|
74072790|NCT02937701|147697962|OTHER||Mean Difference|-0.03|||||TWO_SIDED|90.0|-0.3|0.24||||||Week 34 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.24|-0.30|
74072791|NCT02937701|147697962|OTHER||Mean Difference|0.06|||||TWO_SIDED|90.0|-0.18|0.3||||||Week 38 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.30|-0.18|
73883937|NCT05546476|147301578|SUPERIORITY||Difference in LS Mean|2.3|||=|0.01|TWO_SIDED|90.0|0.68|3.92|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.92|0.68|=0.0100
74072792|NCT02937701|147697962|OTHER||Mean Difference|-0.08|||||TWO_SIDED|90.0|-0.36|0.2||||||Week 38 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.20|-0.36|
74072793|NCT02937701|147697962|OTHER||Mean Difference|0.11|||||TWO_SIDED|90.0|-0.14|0.37||||||Week 46 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.37|-0.14|
74072794|NCT02937701|147697962|OTHER||Mean Difference|-0.05|||||TWO_SIDED|90.0|-0.34|0.25||||||Week 46 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.25|-0.34|
74072795|NCT02937701|147697962|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.24|0.24||||||Week 50 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.24|-0.24|
74072796|NCT02937701|147697962|OTHER||Mean Difference|-0.2|||||TWO_SIDED|90.0|-0.47|0.08||||||Week 50 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.08|-0.47|
74072797|NCT01880073|147697968|OTHER||Proportion|0.875|||||TWO_SIDED|95.0|0.74|1.0||||||||1.00|0.74|
74072798|NCT01880073|147697969|OTHER||Proportion|0.125|||||TWO_SIDED|95.0|0.0|0.26||||||||0.26|0.00|
74072799|NCT00023309|147697972|SUPERIORITY_OR_OTHER|||||||0.0294||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in the treatment effect between the two groups||||0.0294
74072800|NCT00023309|147697973|SUPERIORITY_OR_OTHER|||||||0.0325||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0325
74072801|NCT00023309|147697974|SUPERIORITY_OR_OTHER|||||||0.0049||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0049
74072802|NCT00023309|147697975|SUPERIORITY_OR_OTHER|||||||0.0157||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0157
74072803|NCT00023309|147697976|SUPERIORITY_OR_OTHER|||||||0.0913||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0913
74072804|NCT01866319|147697977|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|1e-05|TWO_SIDED|95.0|0.46|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||0.72|0.46|<0.00001
74072805|NCT01866319|147697977|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|1e-05|TWO_SIDED|95.0|0.47|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||0.72|0.47|<0.00001
74072806|NCT01866319|147697977|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.75869|TWO_SIDED|95.0|0.77|1.21|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||1.21|0.77|0.75869
74072807|NCT01866319|147697978|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.00052|TWO_SIDED|95.0|0.47|0.83|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||0.83|0.47|0.00052
74072808|NCT01866319|147697978|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69||||0.00358|TWO_SIDED|95.0|0.52|0.9|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||0.90|0.52|0.00358
74072809|NCT01866319|147697978|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.51319||95.0|0.67|1.22|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||1.22|0.67|0.51319
74072810|NCT01866319|147697979|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|16.1||||0.00013|TWO_SIDED|95.0|7.8|24.5|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||24.5|7.8|0.00013
74072811|NCT01866319|147697979|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|17.2||||2e-05|TWO_SIDED|95.0|9.5|25.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||25.6|9.5|0.00002
73883938|NCT05546476|147301579|SUPERIORITY||Difference in LS Mean|0.43|||=|0.1912|TWO_SIDED|90.0|-0.38|1.24|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.24|-0.38|=0.1912
74072812|NCT01866319|147697979|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-1.1||||0.82636||95.0|-10.6|8.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||8.6|-10.6|0.82636
74072813|NCT03980483|147697982|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0023|TWO_SIDED|0.95|1.19|2.21|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||2.21|1.19|0.0023
74072814|NCT03980483|147697982|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0362|TWO_SIDED|0.95|1.02|1.89|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||1.89|1.02|0.0362
74072815|NCT03980483|147697982|SUPERIORITY||Odds Ratio (OR)|2.34|||<|0.0001|TWO_SIDED|0.95|1.62|3.37|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 05mg dose of Tofacitinib and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 05mg dose of Tofacitinib differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.37|1.62|<0.0001
73883939|NCT05546476|147301579|SUPERIORITY||Difference in LS Mean|0.46|||=|0.1866|TWO_SIDED|90.0|-0.39|1.3|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.30|-0.39|=0.1866
74072816|NCT03980483|147697982|SUPERIORITY||Odds Ratio (OR)|0.69||||0.023|TWO_SIDED|0.95|0.5|0.95|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.95|0.50|0.0230
74072817|NCT03980483|147697982|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0013|TWO_SIDED|0.95|0.43|0.82|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.82|0.43|0.0013
74072818|NCT03980483|147697985|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 97.5 % Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Mean Difference (Final Values)|-10.4|||||TWO_SIDED|0.975|-18.6|-2.3|||Regression, Logistic|Difference in proportion and 97.5% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-2.3|-18.6|
74072819|NCT03980483|147697985|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 97.5% CI in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Mean Difference (Final Values)|-13.0|||||TWO_SIDED|0.975|-21.2|-4.8|||Regression, Logistic|Difference in proportion and 97.5% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-4.8|-21.2|
74072820|NCT01014728|147698092|SUPERIORITY_OR_OTHER|||||||0.937||95.0|||||t-test, 2 sided|||||||0.937
74072821|NCT01014728|147698093|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
74072822|NCT01014728|147698094|SUPERIORITY_OR_OTHER|||||||0.461||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.461
74072823|NCT01050647|147698110|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
74072824|NCT01050647|147698111|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
74072825|NCT01050647|147698112|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
74072826|NCT01050647|147698113|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
74072827|NCT01050647|147698114|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
74072828|NCT03249584|147698235|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||An improvement from baseline to 3 months post radiofrequency ablation in worst pain score will be demonstrated with an outcome which is statistically lower than zero.||||<0.0001
74072829|NCT04567342|147698244|SUPERIORITY||Risk Ratio (RR)|1.08||||0.531|TWO_SIDED|95.0|0.85|1.37|||Regression, Logistic||||Arm 3 vs. Arm 1|1.37|0.85|0.531
74072830|NCT04567342|147698244|SUPERIORITY||Risk Ratio (RR)|0.84||||0.189|TWO_SIDED|95.0|0.65|1.09|||Regression, Logistic||||Arm 2 vs. Arm 1|1.09|0.65|0.189
74072831|NCT04567342|147698244|SUPERIORITY||Risk Ratio (RR)|1.29||||0.054|TWO_SIDED|95.0|0.1|1.66|||Regression, Logistic||||Arm 3 vs. Arm 2|1.66|0.10|0.054
74072832|NCT04567342|147698244|SUPERIORITY||Risk Ratio (RR)|1.05||||0.654|TWO_SIDED|95.0|0.84|1.32|||Regression, Logistic||||Arm 4 vs. Arm 3|1.32|0.84|0.654
74072833|NCT04567342|147698244|SUPERIORITY||Risk Ratio (RR)|1.36||||0.018|TWO_SIDED|95.0|1.05|1.74|||Regression, Logistic||||Arm 4 vs. Arm 2|1.74|1.05|0.018
74072834|NCT04567342|147698244|SUPERIORITY||Risk Ratio (RR)|1.14||||0.283|TWO_SIDED|95.0|0.9|1.44|||Regression, Logistic||||Arm 4 vs. Arm 1|1.44|0.90|0.283
74072835|NCT04567342|147698245|SUPERIORITY||Risk Ratio (RR)|1.93|||<|0.01|TWO_SIDED|95.0|1.42|2.62|||Regression, Logistic||||Arm 3 vs. Arm 1|2.62|1.42|<0.01
74072836|NCT04567342|147698245|SUPERIORITY||Risk Ratio (RR)|0.82||||0.318|TWO_SIDED|95.0|0.56|1.21|||Regression, Logistic||||Arm 2 vs. Arm 1|1.21|0.56|0.318
74072837|NCT04567342|147698245|SUPERIORITY||Risk Ratio (RR)|2.34|||<|0.01|TWO_SIDED|95.0|1.68|3.26|||Regression, Logistic||||Arm 3 vs. Arm 2|3.26|1.68|<0.01
74072838|NCT04567342|147698245|SUPERIORITY||Risk Ratio (RR)|1.08||||0.535|TWO_SIDED|95.0|0.85|1.36|||Regression, Logistic||||Arm 4 vs. Arm 3|1.36|0.85|0.535
74072839|NCT04567342|147698245|SUPERIORITY||Risk Ratio (RR)|2.52|||<|0.01|TWO_SIDED|95.0|1.82|3.5|||Regression, Logistic||||Arm 4 vs Arm 2|3.50|1.82|<0.01
74072840|NCT04567342|147698245|SUPERIORITY||Risk Ratio (RR)|2.07|||<|0.01|TWO_SIDED|95.0|1.53|2.8|||Regression, Logistic||||Arm 4 vs. Arm 1|2.80|1.53|<0.01
74072841|NCT04567342|147698246|SUPERIORITY||Risk Ratio (RR)|1.17||||0.192|TWO_SIDED|95.0|0.92|1.48|||Regression, Logistic||||Arm 3 vs. Arm 1|1.48|0.92|0.192
74072842|NCT04567342|147698246|SUPERIORITY||Risk Ratio (RR)|0.81||||0.132|TWO_SIDED|95.0|0.62|1.06|||Regression, Logistic||||Arm 2 vs. Arm 1|1.06|0.62|0.132
74072843|NCT04567342|147698246|SUPERIORITY||Risk Ratio (RR)|1.44|||<|0.01|TWO_SIDED|95.0|1.11|1.86|||Regression, Logistic||||Arm 3 vs. Arm 2|1.86|1.11|<0.01
74072844|NCT04567342|147698246|SUPERIORITY||Risk Ratio (RR)|0.92||||0.462|TWO_SIDED|95.0|0.73|1.16|||Regression, Logistic||||Arm 4 vs. Arm 3|1.16|0.73|0.462
74072845|NCT04567342|147698246|SUPERIORITY||Risk Ratio (RR)|1.32||||0.039|TWO_SIDED|95.0|1.01|1.72|||Regression, Logistic||||Arm 4 vs. Arm 2|1.72|1.01|0.039
74072846|NCT04567342|147698246|SUPERIORITY||Risk Ratio (RR)|1.07||||0.57|TWO_SIDED|95.0|0.84|1.37|||Regression, Logistic||||Arm 4 vs. Arm 1|1.37|0.84|0.570
74072847|NCT01226797|147698254|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5834||||0.6668|TWO_SIDED|95.0|0.1|3.51|||Fisher Exact||Odds-ratio and confidence interval obtained from logistic regression with treatment as fixed effect|||3.51|0.10|0.6668
74072848|NCT01226797|147698255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1591||||0.155|TWO_SIDED|95.0|0.01|1.73|||Fisher Exact||Odds-ratio and confidence interval obtained from logistic regression with treatment as fixed effect.|||1.73|0.01|0.1550
74072849|NCT01226797|147698256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.45||||0.1259|TWO_SIDED|95.0|-7.79|58.69||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 1||58.69|-7.79|0.1259
74072850|NCT01226797|147698256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.49||||0.3297|TWO_SIDED|95.0|-14.67|41.66||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||41.66|-14.67|0.3297
74072851|NCT01226797|147698256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.17||||0.3925|TWO_SIDED|95.0|-21.04|51.39||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 3||51.39|-21.04|0.3925
74072852|NCT01226797|147698256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.62||||0.208|TWO_SIDED|95.0|-14.85|64.09||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||64.09|-14.85|0.2080
74072853|NCT01226797|147698258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.87||||0.0577|TWO_SIDED|95.0|-0.78|44.53||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 1||44.53|-0.78|0.0577
74072854|NCT01226797|147698258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.3||||0.3669|TWO_SIDED|95.0|-11.71|30.3||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||30.30|-11.71|0.3669
74072855|NCT01226797|147698258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.09||||0.2482|TWO_SIDED|95.0|-10.62|38.8||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 3||38.80|-10.62|0.2482
74072856|NCT01226797|147698258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.19||||0.0801|TWO_SIDED|95.0|-3.84|62.22||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||62.22|-3.84|0.0801
74072857|NCT01226797|147698266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.06||||0.0031|TWO_SIDED|95.0|-35.67|-8.44||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||-8.44|-35.67|0.0031
74072858|NCT01226797|147698266|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.34||||0.0015|TWO_SIDED|95.0|-25.64|-7.04||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||-7.04|-25.64|0.0015
74072859|NCT04977336|147698281|SUPERIORITY|||||||0.3706|||||||ANCOVA|||||||0.3706
74072860|NCT04977336|147698281|SUPERIORITY|||||||0.5379|||||||ANCOVA|||||||0.5379
73883940|NCT05546476|147301579|SUPERIORITY||Difference in LS Mean|0.92|||=|0.0349|TWO_SIDED|90.0|0.09|1.75|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.75|0.09|=0.0349
73883941|NCT05546476|147301579|SUPERIORITY||Difference in LS Mean|0.47|||=|0.8754|TWO_SIDED|90.0|-0.2|1.14|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.14|-0.20|=0.8754
74072861|NCT04977336|147698281|SUPERIORITY|||||||0.3859|||||||ANCOVA|||||||0.3859
74072862|NCT04977336|147698281|SUPERIORITY|||||||0.0251|||||||ANCOVA|||||||0.0251
74072863|NCT04977336|147698282|SUPERIORITY|||||||0.2318|||||||ANCOVA|||||||0.2318
74072864|NCT04977336|147698282|SUPERIORITY|||||||0.7615|||||||ANCOVA|||||||0.7615
74072865|NCT04977336|147698282|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.3870
74072866|NCT04977336|147698282|SUPERIORITY|||||||0.0823|||||||ANCOVA|||||||0.0823
74072867|NCT04977336|147698283|SUPERIORITY|||||||0.9986|||||||Cochran-Mantel-Haenszel|||||||0.9986
74072868|NCT04977336|147698283|SUPERIORITY|||||||0.4446|||||||Cochran-Mantel-Haenszel|||||||0.4446
74072869|NCT04977336|147698283|SUPERIORITY|||||||0.5978|||||||Cochran-Mantel-Haenszel|||||||0.5978
74072870|NCT04977336|147698283|SUPERIORITY|||||||0.0479|||||||Cochran-Mantel-Haenszel|||||||0.0479
74072871|NCT04977336|147698284|SUPERIORITY|||||||0.9895|||||||Cochran-Mantel-Haenszel|||||||0.9895
74072872|NCT04977336|147698284|SUPERIORITY|||||||0.2731|||||||Cochran-Mantel-Haenszel|||||||0.2731
74072873|NCT04977336|147698284|SUPERIORITY|||||||0.6492|||||||Cochran-Mantel-Haenszel|||||||0.6492
74072874|NCT04977336|147698284|SUPERIORITY|||||||0.5119|||||||Cochran-Mantel-Haenszel|||||||0.5119
74072875|NCT04977336|147698285|SUPERIORITY|||||||0.3158|||||||Cochran-Mantel-Haenszel|||||||0.3158
74072876|NCT04977336|147698285|SUPERIORITY|||||||0.3247|||||||Cochran-Mantel-Haenszel|||||||0.3247
74072877|NCT04977336|147698285|SUPERIORITY|||||||0.8424|||||||Cochran-Mantel-Haenszel|||||||0.8424
74072878|NCT04977336|147698285|SUPERIORITY|||||||0.2312|||||||Cochran-Mantel-Haenszel|||||||0.2312
74072879|NCT01968382|147698302|SUPERIORITY|||||||0.3198|||||||ANOVA|||||||0.3198
74072880|NCT01968382|147698305|SUPERIORITY|||||||0.8462|||||||ANOVA|||||||0.8462
74072881|NCT02003183|147698322|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.1|<|0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This analysis applies to the Amygdala.||||<0.02
74072882|NCT00406848|147698380|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||Tested was the null hypothesis that there would be no difference in changes from baseline (Week 1) to Week 13 on the HAMD-17 Maier subscale between duloxetine and placebo treatment groups.||||0.397
74072883|NCT00406848|147698381|SUPERIORITY_OR_OTHER|||||||0.115||95.0||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.115
74072884|NCT00406848|147698381|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.004
74072885|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.773||95.0||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.773
74072886|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.084
74072887|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||p-value is for Maier subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.059
74072888|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.488||95.0||||p-value is for Bech subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.488
74072889|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||p-value is for HAMD-17 Bech subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.048
74072890|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.529||95.0||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.529
74072891|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.027
74072892|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.749
74072893|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.296
74072894|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.984||95.0||||p-value is for Sleep subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.984
74072895|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||p-value is for Sleep subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.930
74072896|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.934||95.0||||p-value is for Retardation subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.934
74072897|NCT00406848|147698382|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||p-value is for Retardation subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.123
74072898|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||p-value is for Severity of Worst Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.034
74072899|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||p-value is for Severity of Worst Pain - Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.100
74072900|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value is for Severity of Least Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.009
74072901|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||p-value is for Severity of Least Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.126
74072902|NCT00406848|147698383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Severity of Average Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
74072903|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for Severity of Average Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.013
74072904|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value is for Severity of Pain Right Now Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.016
74072905|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.058||95.0||||p-value is for Severity of Pain Right Now Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.058
74072906|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||p-value is for Interference with General Activity Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.011
74072907|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||p-value is for Interference with General Activity Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.060
74072908|NCT00406848|147698383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Mood Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
74072909|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for Interference with Mood Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.002
74072910|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Interference with Walking Ability Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.019
74072911|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||p-value is for Interference with Walking Ability Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.040
74072912|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Interference with Normal Work Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.003
74072913|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||p-value is for Interference with Normal Work Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.014
74072914|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for Interference with Relations with Other People Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.010
74072915|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for Interference with Relations with Other People Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.010
73883942|NCT05546476|147301579|SUPERIORITY||Difference in LS Mean|0.38|||=|0.8205|TWO_SIDED|90.0|-0.31|1.08|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.08|-0.31|=0.8205
74072916|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||p-value is for Interference with Sleep Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.015
74072917|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Interference with Sleep Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.005
74072918|NCT00406848|147698383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Enjoyment of Life Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
74072919|NCT00406848|147698383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Enjoyment of Life Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
74072920|NCT00406848|147698383|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Average Interference Score Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
74072921|NCT00406848|147698383|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for Average Interference Score Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.001
74072922|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Overall Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.005
74072923|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||p-value is for Overall Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.204
74072924|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||p-value is for Headaches Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.078
74072925|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||p-value is for Headaches Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.147
74072926|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value is for Back Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.007
74072927|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for Back Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.013
74072928|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||p-value is for Shoulder Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.124
74072929|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.231||95.0||||p-value is for Shoulder Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.231
74072930|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for Interference with Daily Activities Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.006
74072931|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Interference with Daily Activities Week 25 main effect of treatment.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit||||||0.019
74072932|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for Time in Pain While Awake Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.002
74072933|NCT00406848|147698384|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||p-value is for Time in Pain While Awake Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.036
74072934|NCT00406848|147698385|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||p-value is for PGI-I at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\* Visit||||||0.214
73883943|NCT05546476|147301579|SUPERIORITY||Difference in LS Mean|-0.17|||=|0.3375|TWO_SIDED|90.0|-0.86|0.51|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.51|-0.86|=0.3375
74072935|NCT00406848|147698385|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||p-value is for PGI-I at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\* Visit||||||.063
73883944|NCT05546476|147301579|SUPERIORITY||Difference in LS Mean|0.66|||=|0.9138|TWO_SIDED|90.0|-0.14|1.45|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.45|-0.14|=0.9138
73883945|NCT05546476|147301579|SUPERIORITY||Difference in LS Mean|0.64|||=|0.9011|TWO_SIDED|90.0|-0.18|1.46|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.46|-0.18|=0.9011
74072936|NCT00406848|147698386|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.162
74072937|NCT00406848|147698386|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.009
74072938|NCT00406848|147698387|SUPERIORITY_OR_OTHER|||||||0.555||95.0||||p-value is for change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.555
74072939|NCT00406848|147698387|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||.785
74072940|NCT00406848|147698388|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||p-value is for change from baseline (Week 1) to Week 13.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.255
74072941|NCT00406848|147698388|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.038
74072942|NCT00406848|147698389|SUPERIORITY_OR_OTHER|||||||0.706||95.0||||p-values for Week 13 remission (HAMD17 ≤ 7).|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.706
74072943|NCT00406848|147698389|SUPERIORITY_OR_OTHER|||||||0.694||95.0||||p-values for Week 25 Remission HAMD17 ≤ 7|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.694
74072944|NCT00406848|147698389|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||p-values for Week 13 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.864
74072945|NCT00406848|147698389|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||p-values for Week 25 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.817
74072946|NCT00406848|147698390|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||p-value is for probability of response at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.664
74072947|NCT00406848|147698390|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||p-value is for probability of response at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.310
74072948|NCT00406848|147698392|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model: Onset = Treatment + Visit + Baseline + Treatment\*Visit.||||||0.036
74072949|NCT00406848|147698393|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||p-value is for Systolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.637
74072950|NCT00406848|147698393|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for Diastolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.001
74072951|NCT00406848|147698393|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||p-value is for Systolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.452
74072952|NCT00406848|147698393|SUPERIORITY_OR_OTHER|||||||0.193||95.0||||p-value is for Diastolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.193
74072953|NCT00406848|147698394|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.121
74072954|NCT00406848|147698394|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.038
74072955|NCT00406848|147698395|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Weight change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.003
74072956|NCT00406848|147698395|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||p-value is for Weight change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.127
74072957|NCT00406848|147698396|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||p-value is for Diastolic Blood Pressure.|Fisher Exact|||||||0.135
74072958|NCT00406848|147698396|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for Pulse.|Fisher Exact|||Pulse||||1.00
74072959|NCT00406848|147698396|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||p-value is for Systolic Blood Pressure|Fisher Exact|||||||0.107
74072960|NCT00406848|147698396|SUPERIORITY_OR_OTHER|||||||0.235||95.0||||p-value is for Weight Change (gain)|Fisher Exact|||||||0.235
74072961|NCT00406848|147698396|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||p-value is for Weight Change (loss)|Fisher Exact|||||||0.813
74072962|NCT00406848|147698397|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||p-value is for Sustained Hypertension|Fisher Exact|||||||0.668
74072963|NCT00406848|147698397|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||p-value is for Orthostatic Hypotension|Fisher Exact|||||||0.201
74072964|NCT00406848|147698399|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Platelet Count change from baseline (Week 1) to Week 13.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.003
74072965|NCT00406848|147698399|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Platelet Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||<0.001
74072966|NCT00406848|147698400|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Uric Acid change from baseline (Week 1) to Week 13.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||<0.001
74072967|NCT00406848|147698400|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Uric Acid change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||<0.001
74072968|NCT00406848|147698401|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||p-value is for Erythrocyte Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.014
74072969|NCT00406848|147698402|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Hemoglobin change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||0.019
74072970|NCT00406848|147698402|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||p-value is for Mean Cell Hemoglobin Concentration change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.048
74072971|NCT00406848|147698403|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||p-value is for Chloride change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||0.040
74072972|NCT00406848|147698403|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||p-value is for Fasting Glucose change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.036
74072973|NCT00406848|147698404|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Fisher Exact|||||||0.019
74072974|NCT00406848|147698405|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value is for QT Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.815
74072975|NCT00406848|147698405|SUPERIORITY_OR_OTHER|||||||0.721||95.0||||p-value is for QTcF Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.721
74072976|NCT00406848|147698405|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||p-value is for QTcB Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.376
74072977|NCT00406848|147698405|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||p-value is for PR Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.065
74072978|NCT00406848|147698405|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||p-value is for QRS Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.110
74072979|NCT00406848|147698406|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤7 criteria.|Fisher Exact|||||||0.110
74072980|NCT00406848|147698406|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤10 criteria.|Fisher Exact|||||||0.016
74072981|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.511
74072982|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.300
74072983|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.922||95.0||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.922
74072984|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.190
74072985|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.850
74072986|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.158
74072987|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||p-value is for SDST Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.099
74072988|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.141||95.0||||p-value is for SDST Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.141
74072989|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||p-value is for 2DCT Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.379
74072990|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.858||95.0||||p-value is for 2DCT Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.858
74072991|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.591||95.0||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.591
74072992|NCT00406848|147698407|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.242
74072993|NCT03629249|147698408|SUPERIORITY|||||||0.714|||||||Wilcoxon (Mann-Whitney)|||||||0.714
74072994|NCT03629249|147698408|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|||||||0.734
74072995|NCT03629249|147698409|SUPERIORITY|||||||0.665|||||||Wilcoxon (Mann-Whitney)|||||||0.665
74072996|NCT03629249|147698409|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.910
74072997|NCT02719522|147698442|SUPERIORITY|The primary safety objective was to determine if the 2-sided 95% upper confidence interval of the primary safety endpoint was below the threshold of 15%|||||<|0.001|||||||Clopper-Pearson|||The primary safety objective was to determine if the 2-sided 95% upper confidence interval of the primary safety endpoint was below the threshold of 15%. Missing safety data for subjects who were lost to FU without any evidence of a major stroke/death were imputed in the analysis using multiple imputation. Subjects who withdrew from the study prior to completion and had experienced a major stroke or death were counted towards the primary safety endpoint as having experienced the event.||||<0.001
74072998|NCT01030965|147698450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|||<|0.001|TWO_SIDED|95.0|0.088|0.229|||Repeated Measures Analysis of Covariance|||||0.229|0.088|<0.001
73883946|NCT05546476|147301579|SUPERIORITY||Difference in LS Mean|0.21|||=|0.6618|TWO_SIDED|90.0|-0.61|1.02|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.02|-0.61|=0.6618
73883947|NCT00772538|147301595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.034||0.011||95.0|0.02|0.152||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.152|0.020|0.0110
73883948|NCT00772538|147301596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.031||0.005||95.0|0.027|0.149||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.027|0.0050
74072999|NCT01030965|147698450|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.168|||<|0.001|TWO_SIDED|95.0|0.099|0.238|||Repeated Measures Analysis of Covariance|||||0.238|0.099|<0.001
74073000|NCT01030965|147698450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22|||Repeated Measures Analysis of Covariance|||||0.220|0.080|<0.001
74073001|NCT01054599|147698493|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
74073002|NCT01054599|147698496|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||||||>0.05
74073003|NCT00743197|147698497|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|0|Other|0.0|STANDARD_DEVIATION|0.0||||||||0||||0||||
74073004|NCT04025879|147698506|SUPERIORITY||Cox Proportional Hazard|0.58||||0.00025|TWO_SIDED|95.0|0.43|0.78|||Log Rank||Stratified by randomization stratification factors: PD-L1 Status (\>=1% vs \<1%/not evaluable/indeterminate), disease stage (II vs III), histology (squamous vs non-squamous).|||0.78|0.43|0.00025
73883949|NCT00772538|147301597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||||0.0343
73883950|NCT00772538|147301598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.043||0.0362||95.0|0.006|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.173|0.006|0.0362
73883951|NCT00772538|147301599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.04||0.0007||95.0|0.058|0.214||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.214|0.058|0.0007
73883952|NCT00772538|147301600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.032||0.0067||95.0|0.024|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.024|0.0067
74073005|NCT04025879|147698508|SUPERIORITY||DIFFERENCE OF PCR|20.5|||||TWO_SIDED|95.0|14.3|26.6|||||Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.|||26.6|14.3|
74073006|NCT04025879|147698508|SUPERIORITY||Odds Ratio (OR)|6.64|||||TWO_SIDED|95.0|3.4|12.97|||||Strata adjusted odds ratio using Mantel-Haenszel method.|||12.97|3.40|
74073007|NCT04025879|147698509|SUPERIORITY||DIFFERENCE OF MPR|23.2|||||TWO_SIDED|95.0|15.8|30.6|||||Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.|||30.6|15.8|
74073008|NCT04025879|147698509|SUPERIORITY||Odds Ratio (OR)|4.01||||||95.0|2.48|6.49|||||Strata adjusted odds ratio using Mantel-Haenszel method.|||6.49|2.48|
74073009|NCT02405195|147698535|OTHER|||||||0.638||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA throughout measurement period (before, during and after CPB).||||0.638
74073010|NCT02405195|147698536|OTHER|||||||0.972||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA||||0.972
74073011|NCT02405195|147698537|OTHER||||||<|0.001||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA||||<0.001
74073012|NCT01691248|147698552|SUPERIORITY_OR_OTHER||Percentage Difference|2.2||||0.2778|TWO_SIDED|95.0|-5.1|9.5||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||9.5|-5.1|0.2778
74073013|NCT01691248|147698553|SUPERIORITY_OR_OTHER||Percentage difference|0.6||||0.442|TWO_SIDED|95.0|-7.1|8.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||8.2|-7.1|0.4420
74073014|NCT01691248|147698554|SUPERIORITY_OR_OTHER||Percentage difference|1.9||||0.3091|TWO_SIDED|95.0|-5.5|9.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||9.2|-5.5|0.3091
74073015|NCT02863575|147698555|SUPERIORITY||Least square (LS) means difference|2.68||||0.306|TWO_SIDED|95.0|-2.46|7.82|||ANCOVA|||||7.82|-2.46|0.306
74073016|NCT02863575|147698556|SUPERIORITY||LS mean difference|1.09||||0.056|TWO_SIDED|95.0|-0.03|2.2|||ANCOVA|||SPRID 0-2||2.20|-0.03|0.056
74073017|NCT02863575|147698556|SUPERIORITY||LS means difference|11.13|||<|0.001|TWO_SIDED|95.0|9.54|12.73|||ANCOVA|||SPRID 0-2||12.73|9.54|< 0.001
74073018|NCT02863575|147698556|SUPERIORITY||LS mean difference|10.05|||<|0.001|TWO_SIDED|95.0|8.45|11.64|||ANCOVA|||SPRID 0-2||11.64|8.45|< 0.001
74073019|NCT02863575|147698556|SUPERIORITY||LS mean difference|1.58||||0.177|TWO_SIDED|95.0|-0.72|3.87|||ANCOVA|||SPRID 0-4||3.87|-0.72|0.177
74073020|NCT02863575|147698556|SUPERIORITY||LS mean difference|24.04|||<|0.001|TWO_SIDED|95.0|20.76|27.32|||ANCOVA|||SPRID 0-4||27.32|20.76|< 0.001
74073021|NCT02863575|147698556|SUPERIORITY||LS mean difference|22.46|||<|0.001|TWO_SIDED|95.0|19.18|25.75|||ANCOVA|||SPRID 0-4||25.75|19.18|< 0.001
74073022|NCT02863575|147698556|SUPERIORITY||LS mean difference|2.39||||0.201|TWO_SIDED|95.0|-1.28|6.06|||ANCOVA|||SPRID 0-6||6.06|-1.28|0.201
74073023|NCT02863575|147698556|SUPERIORITY||LS mean difference|34.3|||<|0.001|TWO_SIDED|95.0|29.06|39.55|||ANCOVA|||SPRID 0-6||39.55|29.06|< 0.001
74073024|NCT02863575|147698556|SUPERIORITY||LS mean difference|31.91|||<|0.001|TWO_SIDED|95.0|26.67|37.16|||ANCOVA|||SPRID 0-6||37.16|26.67|< 0.001
74073025|NCT02863575|147698556|SUPERIORITY||LS mean difference|40.85|||<|0.001|TWO_SIDED|95.0|33.49|48.2|||ANCOVA|||SPRID 0-8||48.20|33.49|< 0.001
74073026|NCT02863575|147698556|SUPERIORITY||LS mean difference|38.17|||<|0.001|TWO_SIDED|95.0|30.81|45.52|||ANCOVA|||SPRID 0-8||45.52|30.81|< 0.001
73883953|NCT00772538|147301601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.04||0.0139||95.0|0.02|0.176||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.176|0.020|0.0139
74073027|NCT02863575|147698557|SUPERIORITY||LS means difference|0.73||||0.066|TWO_SIDED|95.0|-0.05|1.5|||ANCOVA|||SPID 0-2||1.50|-0.05|0.066
74073028|NCT02863575|147698557|SUPERIORITY||LS means difference|7.55|||<|0.001|TWO_SIDED|95.0|6.44|8.66|||ANCOVA|||SPID 0-2||8.66|6.44|< 0.001
74073029|NCT02863575|147698557|SUPERIORITY||LS means difference|6.82|||<|0.001|TWO_SIDED|95.0|5.71|7.93|||ANCOVA|||SPID 0-2||7.93|5.71|< 0.001
74073030|NCT02863575|147698557|SUPERIORITY||LS means difference|1.14||||0.165|TWO_SIDED|95.0|-0.47|2.74|||ANCOVA|||SPID 0-4||2.74|-0.47|0.165
74073031|NCT02863575|147698557|SUPERIORITY||LS means difference|16.35|||<|0.001|TWO_SIDED|95.0|14.05|18.64|||ANCOVA|||SPID 0-4||18.64|14.05|< 0.001
74073032|NCT02863575|147698557|SUPERIORITY||LS means difference|15.21|||<|0.001|TWO_SIDED|95.0|12.91|17.51|||ANCOVA|||SPID 0-4||17.51|12.91|< 0.001
74073033|NCT02863575|147698557|SUPERIORITY||LS means difference|1.78||||0.172|TWO_SIDED|95.0|-0.78|4.34|||ANCOVA|||SPID 0-6||4.34|-0.78|0.172
74073034|NCT02863575|147698557|SUPERIORITY||LS means difference|23.37|||<|0.001|TWO_SIDED|95.0|19.71|27.03|||ANCOVA|||SPID 0-6||27.03|19.71|< 0.001
74073035|NCT02863575|147698557|SUPERIORITY||LS means difference|21.59|||<|0.001|TWO_SIDED|95.0|17.93|25.25|||ANCOVA|||SPID 0-6||25.25|17.93|< 0.001
74073036|NCT02863575|147698557|SUPERIORITY||LS means difference|2.1||||0.249|TWO_SIDED|95.0|-1.47|5.67|||ANCOVA|||SPID 0-8||5.67|-1.47|0.249
74073037|NCT02863575|147698557|SUPERIORITY||LS means difference|27.88|||<|0.001|TWO_SIDED|95.0|22.78|32.99|||ANCOVA|||SPID 0-8||32.99|22.78|< 0.001
74073038|NCT02863575|147698557|SUPERIORITY||LS means difference|25.79|||<|0.001|TWO_SIDED|95.0|20.68|30.89|||ANCOVA|||SPID 0-8||30.89|20.68|< 0.001
74073039|NCT02863575|147698558|SUPERIORITY||LS means difference|0.36||||0.044|TWO_SIDED|95.0|0.01|0.71|||ANCOVA|||TOTPAR 0-2||0.71|0.01|0.044
74073040|NCT02863575|147698558|SUPERIORITY||LS means difference|3.59|||<|0.001|TWO_SIDED|95.0|3.09|4.09|||ANCOVA|||TOTPAR 0-2||4.09|3.09|< 0.001
74073041|NCT02863575|147698558|SUPERIORITY||LS means difference|3.23|||<|0.001|TWO_SIDED|95.0|2.73|3.73|||ANCOVA|||TOTPAR 0-2||3.73|2.73|< 0.001
74073042|NCT02863575|147698558|SUPERIORITY||LS means difference|0.44||||0.224|TWO_SIDED|95.0|-0.27|1.15|||ANCOVA|||TOTPAR 0-4||1.15|-0.27|0.224
74073043|NCT02863575|147698558|SUPERIORITY||LS means difference|7.69|||<|0.001|TWO_SIDED|95.0|6.68|8.71|||ANCOVA|||TOTPAR 0-4||8.71|6.68|< 0.001
74073044|NCT02863575|147698558|SUPERIORITY||LS means difference|7.25|||<|0.001|TWO_SIDED|95.0|6.23|8.27|||ANCOVA|||TOTPAR 0-4||8.27|6.23|< 0.001
74073045|NCT02863575|147698558|SUPERIORITY||LS means difference|0.61||||0.293|TWO_SIDED|95.0|-0.53|1.75|||ANCOVA|||TOTPAR 0-6||1.75|-0.53|0.293
74073046|NCT02863575|147698558|SUPERIORITY||LS means difference|10.93|||<|0.001|TWO_SIDED|95.0|9.3|12.56|||ANCOVA|||TOTPAR 0-6||12.56|9.30|< 0.001
74073047|NCT02863575|147698558|SUPERIORITY||LS means difference|10.32|||<|0.001|TWO_SIDED|95.0|8.69|11.95|||ANCOVA|||TOTPAR 0-6||11.95|8.69|< 0.001
74073048|NCT02863575|147698558|SUPERIORITY||LS means difference|0.58||||0.476|TWO_SIDED|95.0|-1.03|2.19|||ANCOVA|||TOTPAR 0-8||2.19|-1.03|0.476
74073049|NCT02863575|147698558|SUPERIORITY||LS means difference|12.96|||<|0.001|TWO_SIDED|95.0|10.66|15.26|||ANCOVA|||TOTPAR 0-8||15.26|10.66|< 0.001
74073050|NCT02863575|147698558|SUPERIORITY||LS means difference|12.38|||<|0.001|TWO_SIDED|95.0|10.08|14.68|||ANCOVA|||TOTPAR 0-8||14.68|10.08|< 0.001
74073051|NCT02863575|147698559|SUPERIORITY||LS means difference|0.01||||0.975|TWO_SIDED|95.0|-0.35|0.36|||ANCOVA|||PRID at 0.25 hour||0.36|-0.35|0.975
74073052|NCT02863575|147698559|SUPERIORITY||LS means difference|0.12||||0.654|TWO_SIDED|95.0|-0.4|0.63|||ANCOVA|||PRID at 0.25 hour||0.63|-0.40|0.654
74073053|NCT02863575|147698559|SUPERIORITY||LS means difference|0.11||||0.67|TWO_SIDED|95.0|-0.4|0.62|||ANCOVA|||PRID at 0.25 hour||0.62|-0.40|0.670
74073054|NCT02863575|147698559|SUPERIORITY||LS means difference|-0.04||||0.917|TWO_SIDED|95.0|-0.7|0.63|||ANCOVA|||PRID at 0.5 hour||0.63|-0.70|0.917
74073055|NCT02863575|147698559|SUPERIORITY||LS means difference|2.26|||<|0.001|TWO_SIDED|95.0|1.31|3.2|||ANCOVA|||PRID at 0.5 hour||3.20|1.31|< 0.001
74073056|NCT02863575|147698559|SUPERIORITY||LS means difference|2.29|||<|0.001|TWO_SIDED|95.0|1.35|3.24|||ANCOVA|||PRID at 0.5 hour||3.24|1.35|< 0.001
74073057|NCT02863575|147698559|SUPERIORITY||LS means difference|0.73||||0.039|TWO_SIDED|95.0|0.04|1.42|||ANCOVA|||PRID at 1 hour||1.42|0.04|0.039
74073058|NCT02863575|147698559|SUPERIORITY||LS means difference|6.11|||<|0.001|TWO_SIDED|95.0|5.12|7.1|||ANCOVA|||PRID at 1 hour||7.10|5.12|< 0.001
74073059|NCT02863575|147698559|SUPERIORITY||LS means difference|5.38|||<|0.001|TWO_SIDED|95.0|4.39|6.37|||ANCOVA|||PRID at 1 hour||6.37|4.39|< 0.001
74073060|NCT02863575|147698559|SUPERIORITY||LS means difference|0.84||||0.015|TWO_SIDED|95.0|0.16|1.52|||ANCOVA|||PRID at 1.5 hour||1.52|0.16|0.015
74073061|NCT02863575|147698559|SUPERIORITY||LS means difference|7.36|||<|0.001|TWO_SIDED|95.0|6.39|8.33|||ANCOVA|||PRID at 1.5 hour||8.33|6.39|< 0.001
74073062|NCT02863575|147698559|SUPERIORITY||LS means difference|6.52|||<|0.001|TWO_SIDED|95.0|5.55|7.49|||ANCOVA|||PRID at 1.5 hour||7.49|5.55|< 0.001
74073063|NCT02863575|147698559|SUPERIORITY||LS means difference|0.62||||0.071|TWO_SIDED|95.0|-0.05|1.3|||ANCOVA|||PRID at 2 hour||1.30|-0.05|0.071
74073064|NCT02863575|147698559|SUPERIORITY||LS means difference|7.62|||<|0.001|TWO_SIDED|95.0|6.65|8.58|||ANCOVA|||PRID at 2 hour||8.58|6.65|< 0.001
74073065|NCT02863575|147698559|SUPERIORITY||LS means difference|6.99|||<|0.001|TWO_SIDED|95.0|6.03|7.96|||ANCOVA|||PRID at 2 hour||7.96|6.03|< 0.001
74073066|NCT02863575|147698559|SUPERIORITY||LS means difference|0.41||||0.243|TWO_SIDED|95.0|-0.28|1.09|||ANCOVA|||PRID at 3 hour||1.09|-0.28|0.243
74073067|NCT02863575|147698559|SUPERIORITY||LS means difference|6.83|||<|0.001|TWO_SIDED|95.0|5.85|7.8|||ANCOVA|||PRID at 3 hour||7.80|5.85|< 0.001
74073068|NCT02863575|147698559|SUPERIORITY||LS means difference|6.42|||<|0.001|TWO_SIDED|95.0|5.44|7.4|||ANCOVA|||PRID at 3 hour||7.40|5.44|< 0.001
74073069|NCT02863575|147698559|SUPERIORITY||LS means difference|0.08||||0.823|TWO_SIDED|95.0|-0.65|0.82|||ANCOVA|||PRID at 4 hour||0.82|-0.65|0.823
74073070|NCT02863575|147698559|SUPERIORITY||LS means difference|6.08|||<|0.001|TWO_SIDED|95.0|5.02|7.14|||ANCOVA|||PRID at 4 hour||7.14|5.02|< 0.001
74073071|NCT02863575|147698559|SUPERIORITY||LS means difference|6.0|||<|0.001|TWO_SIDED|95.0|4.94|7.05|||ANCOVA|||PRID at 4 hour||7.05|4.94|< 0.001
74073072|NCT02863575|147698559|SUPERIORITY||LS means difference|0.31||||0.438|TWO_SIDED|95.0|-0.48|1.11|||ANCOVA|||PRID at 5 hour||1.11|-0.48|0.438
74073073|NCT02863575|147698559|SUPERIORITY||LS means difference|5.47|||<|0.001|TWO_SIDED|95.0|4.33|6.6|||ANCOVA|||PRID at 5 hour||6.60|4.33|< 0.001
74073074|NCT02863575|147698559|SUPERIORITY||LS means difference|5.15|||<|0.001|TWO_SIDED|95.0|4.01|6.29|||ANCOVA|||PRID at 5 hour||6.29|4.01|< 0.001
74073075|NCT02863575|147698559|SUPERIORITY||LS means difference|0.5||||0.25|TWO_SIDED|95.0|-0.35|1.35|||ANCOVA|||PRID at 6 hour||1.35|-0.35|0.250
74073076|NCT02863575|147698559|SUPERIORITY||LS means difference|4.8|||<|0.001|TWO_SIDED|95.0|3.58|6.02|||ANCOVA|||PRID at 6 hour||6.02|3.58|< 0.001
74073077|NCT02863575|147698559|SUPERIORITY||LS means difference|4.3|||<|0.001|TWO_SIDED|95.0|3.08|5.52|||ANCOVA|||PRID at 6 hour||5.52|3.08|< 0.001
74073078|NCT02863575|147698559|SUPERIORITY||LS means difference|0.11||||0.818|TWO_SIDED|95.0|-0.8|1.01|||ANCOVA|||PRID at 7 hour||1.01|-0.80|0.818
74073079|NCT02863575|147698559|SUPERIORITY||LS means difference|3.53|||<|0.001|TWO_SIDED|95.0|2.23|4.82|||ANCOVA|||PRID at 7 hour||4.82|2.23|< 0.001
74073080|NCT02863575|147698559|SUPERIORITY||LS means difference|3.42|||<|0.001|TWO_SIDED|95.0|2.12|4.71|||ANCOVA|||PRID at 7 hour||4.71|2.12|< 0.001
74073081|NCT02863575|147698559|SUPERIORITY||LS means difference|0.18||||0.698|TWO_SIDED|95.0|-0.74|1.11|||ANCOVA|||PRID at 8 hour||1.11|-0.74|0.698
74073082|NCT02863575|147698559|SUPERIORITY||LS means difference|3.02|||<|0.001|TWO_SIDED|95.0|1.69|4.34|||ANCOVA|||PRID at 8 hour||4.34|1.69|< 0.001
74073083|NCT02863575|147698559|SUPERIORITY||LS means difference|2.83|||<|0.001|TWO_SIDED|95.0|1.51|4.16|||ANCOVA|||PRID at 8 hour||4.16|1.51|< 0.001
74073084|NCT02863575|147698560|SUPERIORITY||LS means difference|0.04||||0.575|TWO_SIDED|94.0|-0.09|0.16|||ANCOVA|||PRR score at 0.25 hour||0.16|-0.09|0.575
74073085|NCT02863575|147698560|SUPERIORITY||LS means difference|0.07||||0.426|TWO_SIDED|95.0|-0.11|0.25|||ANCOVA|||PRR score at 0.25 hour||0.25|-0.11|0.426
74073086|NCT02863575|147698560|SUPERIORITY||LS means difference|0.04||||0.686|TWO_SIDED|95.0|-0.14|0.22|||ANCOVA|||PRR score at 0.25 hour||0.22|-0.14|0.686
74073087|NCT02863575|147698560|SUPERIORITY||LS means difference|0.07||||0.543|TWO_SIDED|95.0|-0.15|0.29|||ANCOVA|||PRR score at 0.5 hour||0.29|-0.15|0.543
74073088|NCT02863575|147698560|SUPERIORITY||LS means difference|0.81|||<|0.001|TWO_SIDED|95.0|0.49|1.12|||ANCOVA|||PRR score at 0.5 hour||1.12|0.49|< 0.001
73883954|NCT00772538|147301602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.034||0.0347||95.0|0.005|0.14||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.140|0.005|0.0347
73883955|NCT00772538|147301603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.032||0.1896||95.0|-0.021|0.104||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.104|-0.021|0.1896
74073089|NCT02863575|147698560|SUPERIORITY||LS means difference|0.74|||<|0.001|TWO_SIDED|95.0|0.42|1.05|||ANCOVA|||PRR score at 0.5 hour||1.05|0.42|< 0.001
73883956|NCT00772538|147301604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.032||0.0247||95.0|0.009|0.136||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.136|0.009|0.0247
73883957|NCT00772538|147301605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.043||0.0039||95.0|0.04|0.21||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.210|0.040|0.0039
73883958|NCT00772538|147301606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.04||0.0063||95.0|0.031|0.19||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.190|0.031|0.0063
73883959|NCT00772538|147301607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.041||0.0027||95.0|0.042|0.201||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.201|0.042|0.0027
73883960|NCT00772538|147301608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.293|STANDARD_ERROR_OF_MEAN|4.584|<|0.0001||95.0|13.279|31.308||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||31.308|13.279|<0.0001
73883961|NCT00772538|147301609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.267|STANDARD_ERROR_OF_MEAN|4.699|<|0.0001||95.0|14.027|32.507||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||32.507|14.027|<0.0001
74073090|NCT02863575|147698560|SUPERIORITY||LS means difference|0.24||||0.038|TWO_SIDED|95.0|0.01|0.46|||ANCOVA|||PRR score at 1 hour||0.46|0.01|0.038
74073091|NCT02863575|147698560|SUPERIORITY||LS means difference|2.01|||<|0.001|TWO_SIDED|95.0|1.69|2.33|||ANCOVA|||PRR score at 1 hour||2.33|1.69|< 0.001
74073092|NCT02863575|147698560|SUPERIORITY||LS means difference|1.78|||<|0.001|TWO_SIDED|95.0|1.46|2.09|||ANCOVA|||PRR score at 1 hour||2.09|1.46|< 0.001
74073093|NCT02863575|147698560|SUPERIORITY||LS means difference|0.25||||0.024|TWO_SIDED|95.0|0.03|0.47|||ANCOVA|||PRR score at 1.5 hour||0.47|0.03|0.024
74073094|NCT02863575|147698560|SUPERIORITY||LS means difference|2.33|||<|0.001|TWO_SIDED|95.0|2.02|2.64|||ANCOVA|||PRR score at 1.5 hour||2.64|2.02|< 0.001
74073095|NCT02863575|147698560|SUPERIORITY||LS means difference|2.08|||<|0.001|TWO_SIDED|95.0|1.77|2.39|||ANCOVA|||PRR score at 1.5 hour||2.39|1.77|< 0.001
74073096|NCT02863575|147698560|SUPERIORITY||LS means difference|0.18||||0.103|TWO_SIDED|95.0|-0.04|0.4|||ANCOVA|||PRR score at 2 hour||0.40|-0.04|0.103
74073097|NCT02863575|147698560|SUPERIORITY||LS means difference|2.4|||<|0.001|TWO_SIDED|95.0|2.09|2.71|||ANCOVA|||PRR score at 2 hour||2.71|2.09|< 0.001
74073098|NCT02863575|147698560|SUPERIORITY||LS means difference|2.22|||<|0.001|TWO_SIDED|95.0|1.91|2.53|||ANCOVA|||PRR score at 2 hour||2.53|1.91|< 0.001
74073099|NCT02863575|147698560|SUPERIORITY||LS means difference|0.08||||0.448|TWO_SIDED|95.0|-0.13|0.29|||ANCOVA|||PRR score at 3 hour||0.29|-0.13|0.448
74073100|NCT02863575|147698560|SUPERIORITY||LS means difference|2.16|||<|0.001|TWO_SIDED|95.0|1.86|2.47|||ANCOVA|||PRR score at 3 hour||2.47|1.86|< 0.001
74073101|NCT02863575|147698560|SUPERIORITY||LS means difference|2.08|||<|0.001|TWO_SIDED|95.0|1.78|2.38|||ANCOVA|||PRR score at 3 hour||2.38|1.78|< 0.001
74073102|NCT02863575|147698560|SUPERIORITY||LS means difference|0.0||||0.997|TWO_SIDED|95.0|-0.23|0.23|||ANCOVA|||PRR score at 4 hour||0.23|-0.23|0.997
74073103|NCT02863575|147698560|SUPERIORITY||LS means difference|1.94|||<|0.001|TWO_SIDED|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour||2.28|1.61|< 0.001
74073104|NCT02863575|147698560|SUPERIORITY||LS means difference|1.94|||<|0.001|TWO_SIDED|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour||2.28|1.61|< 0.001
74073105|NCT02863575|147698560|SUPERIORITY||LS means difference|0.06||||0.656|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|||PRR score at 5 hour||0.31|-0.19|0.656
74073106|NCT02863575|147698560|SUPERIORITY||LS means difference|1.73|||<|0.001|TWO_SIDED|95.0|1.36|2.09|||ANCOVA|||PRR score at 5 hour||2.09|1.36|< 0.001
74073107|NCT02863575|147698560|SUPERIORITY||LS means difference|1.67|||<|0.001|TWO_SIDED|95.0|1.31|2.03|||ANCOVA|||PRR score at 5 hour||2.03|1.31|< 0.001
74073108|NCT02863575|147698560|SUPERIORITY||LS means difference|0.11||||0.425|TWO_SIDED|94.0|-0.16|0.38|||ANCOVA|||PRR score at 6 hour||0.38|-0.16|0.425
74073109|NCT02863575|147698560|SUPERIORITY||LS means difference|1.51|||<|0.001|TWO_SIDED|95.0|1.12|1.9|||ANCOVA|||PRR score at 6 hour||1.90|1.12|< 0.001
74073110|NCT02863575|147698560|SUPERIORITY||LS means difference|1.4|||<|0.001|TWO_SIDED|95.0|1.01|1.79|||ANCOVA|||PRR score at 6 hour||1.79|1.01|< 0.001
74073111|NCT02863575|147698560|SUPERIORITY||LS means difference|-0.03||||0.841|TWO_SIDED|95.0|-0.32|0.26|||ANCOVA|||PRR score at 7 hour||0.26|-0.32|0.841
73883962|NCT00772538|147301610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.061|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.173|0.061|<0.0001
73883963|NCT00772538|147301611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.068|0.181||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.181|0.068|<0.0001
73883964|NCT00772538|147301612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.736||0.7012||95.0|-1.165|1.731||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||1.731|-1.165|0.7012
73883965|NCT00772538|147301613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.0499||95.0|0.49|1.0||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||1.00|0.49|0.0499
73883966|NCT00772538|147301614|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71|STANDARD_ERROR_OF_MEAN|0.09||0.0102||95.0|0.55|0.92||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||0.92|0.55|0.0102
73883967|NCT00772538|147301615|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.64|STANDARD_ERROR_OF_MEAN|0.1||0.0062||95.0|0.46|0.88||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||0.88|0.46|0.0062
73883968|NCT00772538|147301616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0065||95.0|0.4|0.88||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||0.88|0.40|0.0065
74073112|NCT02863575|147698560|SUPERIORITY||LS means difference|1.1|||<|0.001|TWO_SIDED|95.0|0.69|1.52|||ANCOVA|||PRR score at 7 hour||1.52|0.69|< 0.001
73883969|NCT00772538|147301617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.0561||95.0|0.42|1.01||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||1.01|0.42|0.0561
73883970|NCT00772538|147301618|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.5604||95.0|0.3|1.92||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium|||1.92|0.30|0.5604
73883971|NCT00772538|147301619|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87|STANDARD_ERROR_OF_MEAN|0.21||0.5538||95.0|0.54|1.39||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.39|0.54|0.5538
73883972|NCT00772538|147301620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.633||95.0|0.25|2.13||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||2.13|0.25|0.6330
73883973|NCT00772538|147301621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.074||0.5714||95.0|-0.103|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.186|-0.103|0.5714
73883974|NCT00772538|147301622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.075||0.6099||95.0|-0.109|0.185||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.185|-0.109|0.6099
73883975|NCT00772538|147301623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.066||0.0586||95.0|-0.256|0.005||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.005|-0.256|0.0586
73883976|NCT00772538|147301624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.067||0.0727||95.0|-0.253|0.011||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.011|-0.253|0.0727
73883977|NCT00772538|147301625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.024||0.9807||95.0|-0.048|0.047||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.047|-0.048|0.9807
73883978|NCT00772538|147301626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.172||0.5927||95.0|-0.43|0.246||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.246|-0.430|0.5927
74073113|NCT02863575|147698560|SUPERIORITY||LS means difference|1.13|||<|0.001|TWO_SIDED|95.0|0.72|1.55|||ANCOVA|||PRR score at 7 hour||1.55|0.72|< 0.001
74073114|NCT02863575|147698560|SUPERIORITY||LS means difference|0.0||||0.98||95.0|-0.3|0.3|||ANCOVA|||PRR score at 8 hour||0.30|-0.30|0.980
74073115|NCT02863575|147698560|SUPERIORITY||LS means difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.36|||ANCOVA|||PRR score at 8 hour||1.36|0.50|< 0.001
74073116|NCT02863575|147698560|SUPERIORITY||LS means difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.35|||ANCOVA|||PRR score at 8 hour||1.35|0.50|< 0.001
74073117|NCT02863575|147698561|SUPERIORITY||LS means difference|-0.03||||0.808|TWO_SIDED|95.0|-0.27|0.21|||ANCOVA|||PID score at 0.25 hour||0.21|-0.27|0.808
73883979|NCT00772538|147301627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0427|TWO_SIDED|95.0|1.01|1.73||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks||1.73|1.01|0.0427
73883980|NCT00772538|147301627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0001|TWO_SIDED|95.0|1.28|2.21||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks||2.21|1.28|0.0001
73883981|NCT00713609|147301630|SUPERIORITY_OR_OTHER|||||||0.692||||||For ILC|ANCOVA|||||||0.692
73883982|NCT00713609|147301630|SUPERIORITY_OR_OTHER|||||||0.467||||||For ILC|ANCOVA|||||||0.467
73883983|NCT00713609|147301630|SUPERIORITY_OR_OTHER|||||||0.281||||||For ILC|ANCOVA|||||||0.281
73883984|NCT00713609|147301630|SUPERIORITY_OR_OTHER|||||||0.075||||||For ILC|ANCOVA|||||||0.075
73883985|NCT00713609|147301630|SUPERIORITY_OR_OTHER||||||<|0.001||||||For ILC|ANCOVA|||||||<0.001
74073118|NCT02863575|147698561|SUPERIORITY||LS means difference|0.04||||0.804|TWO_SIDED|95.0|-0.3|0.39|||ANCOVA|||PID score at 0.25 hour||0.39|-0.30|0.804
73883986|NCT00713609|147301630|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
73883987|NCT00713609|147301630|SUPERIORITY_OR_OTHER|||||||0.803||||||For NILC|ANCOVA|||||||0.803
73883988|NCT00713609|147301630|SUPERIORITY_OR_OTHER|||||||0.175||||||For NILC|ANCOVA|||||||0.175
73883989|NCT00713609|147301630|SUPERIORITY_OR_OTHER|||||||0.552||||||For NILC|ANCOVA|||||||0.552
73883990|NCT00713609|147301630|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
73883991|NCT00713609|147301630|SUPERIORITY_OR_OTHER|||||||0.006||||||For TC|ANCOVA|||||||0.006
73883992|NCT00713609|147301630|SUPERIORITY_OR_OTHER|||||||0.618||||||For TC|ANCOVA|||||||0.618
73883993|NCT00713609|147301630|SUPERIORITY_OR_OTHER|||||||0.149||||||For TC|ANCOVA|||||||0.149
73883994|NCT00713609|147301630|SUPERIORITY_OR_OTHER|||||||0.255||||||For TC|ANCOVA|||||||0.255
73883995|NCT00713609|147301630|SUPERIORITY_OR_OTHER||||||<|0.001||||||For TC|ANCOVA|||||||<0.001
73883996|NCT00713609|147301631|SUPERIORITY_OR_OTHER|||||||0.922|||||||Cochran-Mantel-Haenszel|||||||0.922
74073119|NCT02863575|147698561|SUPERIORITY||LS means difference|0.07||||0.676|TWO_SIDED|95.0|-0.27|0.42|||ANCOVA|||PID score at 0.25 hr||0.42|-0.27|0.676
73883997|NCT00713609|147301631|SUPERIORITY_OR_OTHER|||||||0.132|||||||Cochran-Mantel-Haenszel|||||||0.132
73883998|NCT00713609|147301631|SUPERIORITY_OR_OTHER|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
73883999|NCT00713609|147301631|SUPERIORITY_OR_OTHER|||||||0.706|||||||Cochran-Mantel-Haenszel|||||||0.706
73884000|NCT00713609|147301631|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|||||||0.009
73884001|NCT00713609|147301632|SUPERIORITY_OR_OTHER|||||||0.504||||||For ILC|ANCOVA|||||||0.504
73884002|NCT00713609|147301632|SUPERIORITY_OR_OTHER|||||||0.504||||||For ILC|ANCOVA|||||||0.504
74073120|NCT02863575|147698561|SUPERIORITY||LS means difference|-0.1||||0.654|TWO_SIDED|95.0|-0.55|0.35|||ANCOVA|||PID score at 0.5 hour||0.35|-0.55|0.654
74073121|NCT02863575|147698561|SUPERIORITY||LS means difference|1.45|||<|0.001|TWO_SIDED|95.0|0.81|2.1|||ANCOVA|||PID score at 0.5 hour||2.10|0.81|< 0.001
73884003|NCT00713609|147301632|SUPERIORITY_OR_OTHER|||||||0.177||||||For ILC|ANCOVA|||||||0.177
73884004|NCT00713609|147301632|SUPERIORITY_OR_OTHER|||||||0.084||||||For ILC|ANCOVA|||||||0.084
73884005|NCT00713609|147301632|SUPERIORITY_OR_OTHER||||||<|0.001||||||For ILC|ANCOVA|||||||<0.001
73884006|NCT00713609|147301632|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
73884007|NCT00713609|147301632|SUPERIORITY_OR_OTHER|||||||0.776||||||For NILC|ANCOVA|||||||0.776
73884008|NCT00713609|147301632|SUPERIORITY_OR_OTHER|||||||0.465||||||For NILC|ANCOVA|||||||0.465
73884009|NCT00713609|147301632|SUPERIORITY_OR_OTHER|||||||0.288||||||For NILC|ANCOVA|||||||0.288
73884010|NCT00713609|147301632|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
73884011|NCT00713609|147301632|SUPERIORITY_OR_OTHER|||||||0.006||||||For TC|ANCOVA|||||||0.006
73884012|NCT00713609|147301632|SUPERIORITY_OR_OTHER|||||||0.62||||||For TC|ANCOVA|||||||0.620
73884013|NCT00713609|147301632|SUPERIORITY_OR_OTHER|||||||0.291||||||For TC|ANCOVA|||||||0.291
73884014|NCT00713609|147301632|SUPERIORITY_OR_OTHER|||||||0.085||||||For TC|ANCOVA|||||||0.085
73884015|NCT00713609|147301632|SUPERIORITY_OR_OTHER||||||<|0.001||||||For TC|ANCOVA|||||||<0.001
73884016|NCT00713609|147301633|SUPERIORITY_OR_OTHER|||||||0.652|||||||Cochran-Mantel-Haenszel|||||||0.652
73884017|NCT00713609|147301633|SUPERIORITY_OR_OTHER|||||||0.279|||||||Cochran-Mantel-Haenszel|||||||0.279
73884018|NCT00713609|147301633|SUPERIORITY_OR_OTHER|||||||0.312|||||||Cochran-Mantel-Haenszel|||||||0.312
73884019|NCT00713609|147301633|SUPERIORITY_OR_OTHER|||||||0.063|||||||Cochran-Mantel-Haenszel|||||||0.063
73884020|NCT00713609|147301633|SUPERIORITY_OR_OTHER|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
73884021|NCT01791244|147301706|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.48||||0.9148|TWO_SIDED|95.0|-8.3|9.25|||linear mixed model|||Linear mixed model, with baseline value, time, Expanded Disability Status Score (EDSS) at baseline and sex as fixed factors was used for the analysis.||9.25|-8.30|0.9148
73884022|NCT01856270|147301778|SUPERIORITY|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.114||||0.101|ONE_SIDED|95.0|-0.017|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 71 of 205 participants (at 3 Mo post) in the Natural History study endorsed having a headache more than once per week.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening.|||-0.017|.101
74073122|NCT02863575|147698561|SUPERIORITY||LS means difference|1.55|||<|0.001|TWO_SIDED|95.0|0.91|2.2|||ANCOVA|||PID score at 0.5 hour||2.20|0.91|< 0.001
74073123|NCT02863575|147698561|SUPERIORITY||LS means difference|0.49||||0.045|TWO_SIDED|95.0|0.01|0.97|||ANCOVA|||PID score at 1 hour||0.97|0.01|0.045
74073124|NCT02863575|147698561|SUPERIORITY||LS means difference|4.1|||<|0.001||95.0|3.41|4.78|||ANCOVA|||PID score at 1 hour||4.78|3.41|< 0.001
74073125|NCT02863575|147698561|SUPERIORITY||LS means difference|3.6|||<|0.001|TWO_SIDED|95.0|2.92|4.29|||ANCOVA|||PID score at 1 hour||4.29|2.92|< 0.001
73888353|NCT02683577|147309567|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.0|||||TWO_SIDED|90.0|1.51|2.66|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on Cmax values for LP-778902.||2.66|1.51|
73884023|NCT01856270|147301779|SUPERIORITY|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.194||||0.017|ONE_SIDED|95.0|0.057|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 56 of 148 participants (at 3 mo post) in the Natural History study reported pain \>=6.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening|||.057|.017
73884024|NCT01856270|147301780|SUPERIORITY||Difference of proportions|0.093||||0.456|TWO_SIDED|95.0|-0.106|0.286||A priori significance threshold α=.05|Fisher Exact||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed). Confidence interval estimation method from Wallenstein (1997).|||.286|-.106|.456
73884025|NCT01856270|147301781|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.684|TWO_SIDED|95.0|-5.1|3.4||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||3.4|-5.1|.684
73884026|NCT01856270|147301782|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.306|TWO_SIDED|95.0|-1.0|2.9||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||2.9|-1.0|.306
73884027|NCT01856270|147301783|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.583|TWO_SIDED|95.0|-0.9|1.6||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||1.6|-0.9|.583
73884028|NCT01856270|147301784|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.444|TWO_SIDED|95.0|-4.0|8.8||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||8.8|-4.0|.444
73884029|NCT01856270|147301785|SUPERIORITY||Mean Difference (Final Values)|27.3||||0.041|TWO_SIDED|95.0|1.2|53.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||53.3|1.2|.041
73884030|NCT01856270|147301786|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.089|TWO_SIDED|95.0|-3.8|0.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||0.3|-3.8|.089
73884031|NCT02893293|147301832|OTHER|||||||0.002||||||A p-value less than the a priori threshold of 0.05 was considered statistically significant.|Mixed Models Analysis|Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.||||||0.002
73884032|NCT02893293|147301833|OTHER|||||||0.02||||||A p-value less than the a priori threshold of 0.05 was considered statistically significant.|Mixed Models Analysis|Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.||||||0.02
74073126|NCT02863575|147698561|SUPERIORITY||LS means difference|0.59||||0.015|TWO_SIDED|95.0|0.11|1.06|||ANCOVA|||PID score at 1.5 hour||1.06|0.11|0.015
74073127|NCT02863575|147698561|SUPERIORITY||LS means difference|5.03|||<|0.001|TWO_SIDED|95.0|4.35|5.71|||ANOVA|||PID score at 1.5 hour||5.71|4.35|< 0.001
74073128|NCT02863575|147698561|SUPERIORITY||LS means difference|4.44|||<|0.001|TWO_SIDED|95.0|3.76|5.12|||ANCOVA|||PID score at 1.5 hour||5.12|3.76|< 0.001
74073129|NCT02863575|147698561|SUPERIORITY||LS means difference|0.44||||0.066|TWO_SIDED|95.0|-0.03|0.91|||ANCOVA|||PID score at 2 hour||0.91|-0.03|0.066
74073130|NCT02863575|147698561|SUPERIORITY||LS means difference|5.22|||<|0.001|TWO_SIDED|95.0|4.54|5.89|||ANCOVA|||PID score at 2 hour||5.89|4.54|< 0.001
74073131|NCT02863575|147698561|SUPERIORITY||LS means difference|4.78|||<|0.001|TWO_SIDED|95.0|4.1|5.45|||ANCOVA|||PID score at 2 hour||5.45|4.10|< 0.001
74073132|NCT02863575|147698561|SUPERIORITY||LS means difference|0.32||||0.186|TWO_SIDED|95.0|-0.16|0.81|||ANCOVA|||PID score at 3 hour||0.81|-0.16|0.186
74073133|NCT02863575|147698561|SUPERIORITY||LS means difference|4.66|||<|0.001|TWO_SIDED|95.0|3.98|5.35|||ANCOVA|||PID score at 3 hour||5.35|3.98|< 0.001
74073134|NCT02863575|147698561|SUPERIORITY||LS means difference|4.34|||<|0.001|TWO_SIDED|95.0|3.65|5.03|||ANCOVA|||PID score at 3 hour||5.03|3.65|< 0.001
74073135|NCT02863575|147698561|SUPERIORITY||LS means difference|0.08||||0.75|TWO_SIDED|95.0|-0.43|0.6|||ANCOVA|||PID score at 4 hour||0.60|-0.43|0.750
74073136|NCT02863575|147698561|SUPERIORITY||LS means difference|4.14|||<|0.001|TWO_SIDED|95.0|3.4|4.87|||ANCOVA|||PID score at 4 hour||4.87|3.40|< 0.001
74073137|NCT02863575|147698561|SUPERIORITY||LS means difference|4.05|||<|0.001|TWO_SIDED|95.0|3.32|4.79|||ANCOVA|||PID score at 4 hour||4.79|3.32|< 0.001
74073138|NCT02863575|147698561|SUPERIORITY||LS means difference|0.26||||0.361|TWO_SIDED|95.0|-0.3|0.81|||ANCOVA|||PID score at 5 hour||0.81|-0.30|0.361
74073139|NCT02863575|147698561|SUPERIORITY||LS means difference|3.74|||<|0.001|TWO_SIDED|95.0|2.95|4.53|||ANCOVA|||PID score at 5 hour||4.53|2.95|< 0.001
74073140|NCT02863575|147698561|SUPERIORITY||LS means difference|3.48|||<|0.001|TWO_SIDED|95.0|2.69|4.27|||ANCOVA|||PID score at 5 hour||4.27|2.69|< 0.001
74073141|NCT02863575|147698561|SUPERIORITY||LS means difference|0.39||||0.195|TWO_SIDED|95.0|-0.2|0.98|||ANCOVA|||PID score at 6 hour||0.98|-0.20|0.195
74073142|NCT02863575|147698561|SUPERIORITY||LS means difference|3.29|||<|0.001|TWO_SIDED|95.0|2.44|4.13|||ANCOVA|||PID score at 6 hour||4.13|2.44|< 0.001
74073143|NCT02863575|147698561|SUPERIORITY||LS means difference|2.9|||<|0.001|TWO_SIDED|95.0|2.06|3.74|||ANCOVA|||PID score at 6 hour||3.74|2.06|< 0.001
74073144|NCT02863575|147698561|SUPERIORITY||LS means difference|0.14||||0.669|TWO_SIDED|95.0|-0.49|0.76|||ANCOVA|||PID score at 7 hour||0.76|-0.49|0.669
74073145|NCT02863575|147698561|SUPERIORITY||LS means difference|2.42|||<|0.001|TWO_SIDED|95.0|1.53|3.31|||ANCOVA|||PID score at 7 hour||3.31|1.53|< 0.001
74073146|NCT02863575|147698561|SUPERIORITY||LS means difference|2.29|||<|0.001|TWO_SIDED|95.0|1.4|3.18|||ANCOVA|||PID score at 7 hour||3.18|1.40|< 0.001
74073147|NCT02863575|147698561|SUPERIORITY||LS means difference|0.18||||0.581|TWO_SIDED|95.0|-0.46|0.82|||ANCOVA|||PID score at 8 hour||0.82|-0.46|0.581
74073148|NCT02863575|147698561|SUPERIORITY||LS means difference|2.09|||<|0.001|TWO_SIDED|95.0|1.18|3.0|||ANCOVA|||PID score at 8 hour||3.00|1.18|< 0.001
74073149|NCT02863575|147698561|SUPERIORITY||LS means difference|1.91|||<|0.001|TWO_SIDED|95.0|1.0|2.82|||ANCOVA|||PID score at 8 hour||2.82|1.00|< 0.001
73888354|NCT02683577|147309568|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|0.316|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||1.000|0.000|=0.3160
74073150|NCT02863575|147698562|SUPERIORITY|||||||0.028|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.028
74073151|NCT02863575|147698562|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
74073152|NCT02863575|147698562|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
74073153|NCT02863575|147698563|SUPERIORITY|||||||0.861|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.861
74073154|NCT02863575|147698563|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
74073155|NCT02863575|147698563|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
74073156|NCT02863575|147698564|SUPERIORITY|||||||0.838|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.838
74073157|NCT02863575|147698564|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
74073158|NCT02863575|147698564|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
74073159|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.4||||||95.0|-2.2|1.0||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.0|-2.2|
74073160|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-4.0|3.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥16 EU/mL threshold was calculated.||3.8|-4.0|
74073161|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.4|-1.6|
74073162|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated.||1.4|-1.6|
74073163|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.9||||||95.0|-5.0|2.9||||||For Pertussis FHA the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥31 EU/mL threshold was calculated.||2.9|-5.0|
74073164|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.5|1.4||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.4|-1.5|
74073165|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.2||||||95.0|-7.8|1.0||||||For Pertactin the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥40 EU/mL threshold was calculated.||1.0|-7.8|
74073166|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-3.6|5.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.||5.0|-3.6|
74073167|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.2||||||95.0|-9.1|2.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated.||2.4|-9.1|
74073168|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-8.2|9.5||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||9.5|-8.2|
74073169|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.8|1.6||||||For Diptheria the difference in percentages between the two groups ( 13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.||1.6|-1.8|
74073170|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.5||||||95.0|-8.3|0.8||||||For Diptheria the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||0.8|-8.3|
74073171|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|1.7||||||95.0|-3.9|7.1||||||For Tetanus the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||7.1|-3.9|
73884033|NCT03668873|147301852|SUPERIORITY||Difference of Least Squares Means|-1.85|||<|0.001|TWO_SIDED|95.0|-2.88|-0.81||Threshold for significance was p=0.05.|Mixed Models Analysis|Mixed models with repeated measures with fixed effects for baseline CSI, treatment, week as a categorical variable, and treatment-week interaction.|Treatment difference = SPT minus SPE.|The null hypothesis was that the SPE and SPT groups did not differ on change in CSI score at 10 weeks. Assuming a standard deviation of 2.5 units and an attrition rate of 10%, an enrollment target of 90 participants would provide 90% power to detect a difference of 1.85 points or greater with a type I error rate of 0.05 using a two-tailed two-sample t-test.||-0.81|-2.88|<0.001
73888355|NCT02683577|147309568|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|0.4671|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||1.000|0.000|=0.4671
74073172|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.1||||||95.0|-2.3|1.7||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||1.7|-2.3|
74073173|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-1.0||||||95.0|-5.0|2.8||||||For Polio Type 2 the difference in percentage between the two groups ( 13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.8|-5.0|
74073174|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-1.6|2.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.9|-1.6|
74073175|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.7|-1.6|
74073176|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-2.7||||||95.0|-7.3|1.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥21 EU/mL threshold was calculated.||1.8|-7.3|
74073177|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.7|-1.6|
74073178|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated||1.7|-1.6|
74073179|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.1||||||95.0|-4.3|4.1||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥162 EU/mL threshold was calculated||4.1|-4.3|
74073180|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.7|-1.6|
74073181|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.5||||||95.0|-4.7|3.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥106 EU/mL threshold was calculated.||3.7|-4.7|
74073182|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.4||||||95.0|-3.0|2.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.||2.0|-3.0|
74073183|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|1.4||||||95.0|-0.8|4.2||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated||4.2|-0.8|
74073184|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|4.0||||||95.0|-0.4|8.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||8.7|-0.4|
74073185|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.||2.0|-2.3|
74073186|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||2.0|-2.3|
74073187|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|3.8||||||95.0|-1.7|10.9||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||10.9|-1.7|
74073188|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
74073189|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
74073190|NCT00366899|147698588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
74073191|NCT00366899|147698589|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.87|1.1||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.87|
74073192|NCT00366899|147698589|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.92|1.16||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.92|
74073193|NCT00366899|147698589|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.87|1.17||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.87|
74073194|NCT00366899|147698589|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.89|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.89|
74073195|NCT00366899|147698589|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.83|1.07||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.83|
74073196|NCT00366899|147698589|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.07||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.82|
74073197|NCT00366899|147698592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the geometric mean concentration (GMC)/geometric mean titer (GMT) ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.96||||||95.0|0.72|1.27||||||For Hepatitis b the geometric mean concentration (GMC) ratio (13vPnC/7vPnC) was calculated||1.27|0.72|
74073198|NCT00366899|147698592|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.54|0.96||||||For Hepatitis b the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.54|
74073199|NCT00366899|147698593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.75|1.3||||||or Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.30|0.75|
74073200|NCT00366899|147698593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.81|1.3||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.30|0.81|
74073201|NCT00366899|147698594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.65|0.94||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.94|0.65|
74073202|NCT00366899|147698594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.67|1.08||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.67|
74073203|NCT00366899|147698594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.75||||||95.0|0.63|0.89||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.89|0.63|
74073204|NCT00366899|147698594|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.25||||||95.0|0.88|1.79||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.79|0.88|
74073205|NCT00366899|147698595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.7|1.08||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.70|
74073206|NCT00366899|147698595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.74|1.22||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated||1.22|0.74|
74073207|NCT00366899|147698595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.68|1.13||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.68|
74073208|NCT00366899|147698595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.69||||||95.0|0.55|0.86||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated||0.86|0.55|
74073209|NCT00366899|147698595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.68|1.07||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.68|
74073210|NCT00366899|147698595|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.51|0.83||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated||0.83|0.51|
74073211|NCT02848326|147698607|SUPERIORITY||Least squares mean difference|-1.15|STANDARD_ERROR_OF_MEAN|0.4||0.0039|TWO_SIDED|95.0|-1.93|-0.37||Mixed-effects model for repeated measures (MMRM) model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.37|-1.93|0.0039
74073212|NCT02848326|147698607|SUPERIORITY||Least squares mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.33||0.0056|TWO_SIDED|95.0|-1.55|-0.27||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.27|-1.55|0.0056
74073213|NCT02848326|147698607|SUPERIORITY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.33||0.0325|TWO_SIDED|95.0|-1.35|-0.06||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.06|-1.35|0.0325
74073214|NCT02848326|147698607|SUPERIORITY||Least squares mean difference|-1.39|STANDARD_ERROR_OF_MEAN|0.42||0.001|TWO_SIDED|95.0|-2.21|-0.56||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.56|-2.21|0.0010
74073215|NCT02848326|147698607|SUPERIORITY||Least squares mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.41||0.0016|TWO_SIDED|95.0|-2.09|-0.49||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.49|-2.09|0.0016
74073216|NCT02848326|147698608|SUPERIORITY||Least squares mean difference|-1.38|STANDARD_ERROR_OF_MEAN|0.43||0.0014|TWO_SIDED|95.0|-2.23|-0.54||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.54|-2.23|0.0014
74073217|NCT02848326|147698608|SUPERIORITY||Least squares mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.36||0.0005|TWO_SIDED|95.0|-1.94|-0.55||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.55|-1.94|0.0005
74073218|NCT02848326|147698608|SUPERIORITY||Least squares mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.36||0.0087|TWO_SIDED|95.0|-1.64|-0.24||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.24|-1.64|0.0087
73884034|NCT03668873|147301853|SUPERIORITY||Absolute percent difference|24.0||||0.037|TWO_SIDED|95.0|2.0|46.0||Threshold for significance was 0.05|Chi-squared||Difference = SPT minus SPE.|The null hypothesis was that the SPE and SPT groups did not differ on the rate of positive response to CGI-I at 10 weeks. Assuming a 25%-40% positive response rate at 10 weeks in the SPE group and 45 patients per group, power was 90% to detect a 32% or greater difference in positive response rate (57%-72% in SPT group, respectively), with a type I error rate of 0.05 using a Chi-square test.||46|2|0.037
74073219|NCT02848326|147698608|SUPERIORITY||Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.46||0.0044|TWO_SIDED|95.0|-2.2|-0.41||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.41|-2.20|0.0044
74073220|NCT02848326|147698608|SUPERIORITY||Least squares mean difference|-1.39|STANDARD_ERROR_OF_MEAN|0.44||0.0017|TWO_SIDED|95.0|-2.26|-0.53||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.53|-2.26|0.0017
74073221|NCT02848326|147698609|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0617|TWO_SIDED|95.0|0.98|2.31||Generalized linear mixed model (GLMM) for repeated measures with fixed factors(treatment group,visit), covariates(baseline migraine days), interactions(treatment group;baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.31|0.98|0.0617
74073222|NCT02848326|147698609|SUPERIORITY||Odds Ratio (OR)|1.46||||0.0369|TWO_SIDED|95.0|1.02|2.08||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.08|1.02|0.0369
74073223|NCT02848326|147698609|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0512|TWO_SIDED|95.0|1.0|2.03||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.03|1.00|0.0512
73884035|NCT03668873|147301854|SUPERIORITY|||||||0.81||||||threshold for significant 0.05|Mixed Models Analysis|||||||0.81
73884036|NCT03668873|147301855|SUPERIORITY|||||||0.77||||||Threshold for significance was 0.05|Mixed Models Analysis|||||||0.77
73884037|NCT03668873|147301856|SUPERIORITY|||||||0.003||||||Threshold for significance was 0.05|Mixed Models Analysis|||||||0.003
73884038|NCT00784563|147301861|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.|Regression, Linear|||Sample size was estimated using 80% power to detect an effect size of 0.66 SD in VO2max (estimated improvement=10% /estimated SD of change=15%) within each arm at alpha=0.05 and an attrition rate of 25%.||||<0.001
74073224|NCT02848326|147698609|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0113|TWO_SIDED|95.0|1.15|2.91||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.91|1.15|0.0113
74073225|NCT02848326|147698609|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0019|TWO_SIDED|95.0|1.3|3.18||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measure|||||3.18|1.30|0.0019
74073226|NCT02848326|147698610|SUPERIORITY||Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.35||0.0002|TWO_SIDED|95.0|-1.99|-0.6||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.60|-1.99|0.0002
74073227|NCT02848326|147698610|SUPERIORITY||Least squares mean difference|-1.44|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.01|-0.87||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.87|-2.01|<0.0001
73884039|NCT00784563|147301862|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
73884040|NCT00784563|147301863|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Regression, Linear|||||||0.029
73884041|NCT00784563|147301864|SUPERIORITY_OR_OTHER|||||||0.271|TWO_SIDED||||||Regression, Linear|||||||0.271
73884042|NCT00784563|147301865|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||unadjusted p-value=0.009|Regression, Linear|||||||0.070
73884043|NCT00784563|147301866|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
73884044|NCT00784563|147301867|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Regression, Linear|||||||0.006
73884045|NCT00784563|147301868|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Regression, Linear|||||||0.002
73884046|NCT00784563|147301869|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Regression, Linear|Adjusted for change in total daily equivalent levodopa dose||||||0.003
73884047|NCT00784563|147301870|SUPERIORITY_OR_OTHER||||||=|0.146|TWO_SIDED||||||t-test, 2 sided|||||||=0.146
73884048|NCT00784563|147301871|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Linear|||||||0.037
73884049|NCT00784563|147301872|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.057
73884050|NCT04576988|147301924|OTHER||Treatment difference|40.8|||<|0.001|TWO_SIDED|95.0|27.53|54.14||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|Aligned Rank Stratified Wilcoxon (ARSW)|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% confidence interval (CI) was reported.|||54.14|27.53|<0.001
73884051|NCT04576988|147301927|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|A 2-sided p-value was calculated using Cochran-Mantel-Haenszel (CMH) method with WHO FC II/III and background PAH therapy as strata.||||||<0.001
74073228|NCT02848326|147698610|SUPERIORITY||Least squares mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.29||0.0001|TWO_SIDED|95.0|-1.68|-0.54||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.54|-1.68|0.0001
74073229|NCT02848326|147698610|SUPERIORITY||Least squares mean difference|-1.35|STANDARD_ERROR_OF_MEAN|0.37||0.0003|TWO_SIDED|95.0|-2.08|-0.62||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.62|-2.08|0.0003
74073230|NCT02848326|147698610|SUPERIORITY||Least squares mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.36||0.0007|TWO_SIDED|95.0|-1.93|-0.52||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.52|-1.93|0.0007
74073231|NCT00414466|147698620|SUPERIORITY_OR_OTHER|||||||0.802||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.802
74073232|NCT00414466|147698620|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.874
74073233|NCT00414466|147698620|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.899
74073234|NCT00414466|147698621|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
74073235|NCT00414466|147698621|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
74073236|NCT00414466|147698621|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
74073237|NCT00414466|147698622|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||0.083
74073238|NCT00414466|147698622|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||1.000
74073239|NCT00414466|147698622|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||0.352
74073240|NCT02999178|147698623|SUPERIORITY||Adjusted mean difference|106.96|STANDARD_ERROR_OF_MEAN|21.15|<|0.0001|TWO_SIDED|95.0|65.42|148.5||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|"Fixed effects: Treatment, HRCT fibrotic pattern, baseline FVC (mL), treatment-by-time, baseline-by-time interactions.~Random effects: time, intercept."|Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).||148.50|65.42|<.0001
74073241|NCT02999178|147698624|SUPERIORITY||Adjusted mean difference|128.2|STANDARD_ERROR_OF_MEAN|29.17|<|0.0001|TWO_SIDED|95.0|70.81|185.59||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|Fixed effects: Treatment, baseline FVC (mL), treatment-by-time, baseline-by-time interactions. Random effects: time, intercept.|Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).||185.59|70.81|<.0001
74073242|NCT02999178|147698625|OTHER|No formal hypotheses were tested.|Adjusted mean difference|1.34|STANDARD_ERROR_OF_MEAN|0.84||0.1115|TWO_SIDED|95.0|-0.31|2.98|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||2.98|-0.31|0.1115
74073243|NCT02999178|147698626|OTHER|No formal hypotheses were tested.|Adjusted mean difference|1.53|STANDARD_ERROR_OF_MEAN|1.12||0.1747|TWO_SIDED|95.0|-0.68|3.74|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||3.74|-0.68|0.1747
74073244|NCT02999178|147698627|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.8||||0.3948|TWO_SIDED|95.0|0.48|1.34|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.34|0.48|0.3948
74073245|NCT02999178|147698628|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.67||||0.1985|TWO_SIDED|95.0|0.36|1.24|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.24|0.36|0.1985
74073246|NCT02999178|147698629|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.94||||0.8544|TWO_SIDED|95.0|0.47|1.86|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.86|0.47|0.8544
74073247|NCT02999178|147698630|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.68||||0.3291|TWO_SIDED|95.0|0.32|1.47|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.47|0.32|0.3291
74073248|NCT02999178|147698633|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.65||||0.0017|TWO_SIDED|95.0|0.49|0.85|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||0.85|0.49|0.0017
73884052|NCT04576988|147301928|OTHER||Treatment difference|-234.6|||<|0.001|TWO_SIDED|95.0|-288.37|-180.75||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-180.75|-288.37|<0.001
74073249|NCT02999178|147698634|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.64||||0.0081|TWO_SIDED|95.0|0.45|0.89|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||0.89|0.45|0.0081
74073250|NCT02999178|147698635|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.7|||||TWO_SIDED|95.0|0.52|0.96|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred and binary covariate HRCT fibrotic pattern.|Ratio calculated as Nintedanib divided by Placebo.|||0.96|0.52|
74073251|NCT02999178|147698636|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.63|||||TWO_SIDED|95.0|0.43|0.94|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred.|Ratio calculated as Nintedanib divided by Placebo.|||0.94|0.43|
74073252|NCT02999178|147698637|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.5|||||TWO_SIDED|95.0|0.36|0.68|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred and binary covariate HRCT fibrotic pattern.|Ratio calculated as Nintedanib divided by Placebo.|||0.68|0.36|
74073253|NCT02999178|147698638|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.46|||||TWO_SIDED|95.0|0.31|0.69|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred.|Ratio calculated as Nintedanib divided by Placebo.|||0.69|0.31|
74073254|NCT02999178|147698639|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-3.53|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|-6.14|-0.92|||Mixed Model Repeated Measures|Fixed effects: baseline, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-0.92|-6.14|
74073255|NCT02999178|147698640|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-4.18|STANDARD_ERROR_OF_MEAN|1.68|||TWO_SIDED|95.0|-7.48|-0.88|||Mixed Model Repeated Measures|Fixed effects: baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-0.88|-7.48|
74073256|NCT02999178|147698641|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-6.09|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|95.0|-9.65|-2.53|||Mixed Model Repeated Measures|Fixed effects: baseline, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-2.53|-9.65|
74073257|NCT02999178|147698642|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-7.28|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-11.86|-2.71|||Mixed Model Repeated Measures|Fixed effects: baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-2.71|-11.86|
74073258|NCT03480425|147698643|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|4.4|<|0.05|TWO_SIDED|95.0|-2.4|2.6|||t-test, 2 sided|||||2.6|-2.4|<0.05
74073259|NCT02424188|147698649|SUPERIORITY||Odds Ratio (OR)|5.9|||||TWO_SIDED|95.0|2.3|15.4||||||||15.4|2.3|
74073260|NCT02424188|147698650|SUPERIORITY||Odds Ratio (OR)|3.9|||||TWO_SIDED|95.0|1.2|12.3||||||||12.3|1.2|
74073261|NCT02424188|147698651|SUPERIORITY||Odds Ratio (OR)|4.8|||||TWO_SIDED|95.0|1.3|17.5||||||6 month comparison||17.5|1.3|
74073262|NCT02424188|147698651|SUPERIORITY||Odds Ratio (OR)|10.8|||||TWO_SIDED|95.0|2.4|48.6||||||12 month||48.6|2.4|
74073263|NCT02424188|147698653|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-1.7|2.3||||||6 months||2.3|-1.7|
74073264|NCT02424188|147698653|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-1.5|4.7||||||18 months||4.7|-1.5|
74073265|NCT02424188|147698654|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.6|1.5||||||||1.5|-0.6|
74073266|NCT02424188|147698656|SUPERIORITY||Mean Difference (Net)|-16.2|||||TWO_SIDED|95.0|-30.2|-2.3||||||||-2.3|-30.2|
74073267|NCT02086188|147698677|SUPERIORITY|||||||0.1911|||||||ANCOVA|||||||0.1911
74073268|NCT02086188|147698678|SUPERIORITY|||||||0.4271|||||||ANCOVA|||||||0.4271
74073269|NCT02086188|147698679|SUPERIORITY|||||||0.1723|||||||ANCOVA|||||||0.1723
74073270|NCT02086188|147698680|SUPERIORITY|||||||0.634|||||||ANCOVA|||||||0.6340
74073271|NCT02086188|147698681|SUPERIORITY|||||||0.0091|||||||ANCOVA|||||||0.0091
74073272|NCT01492361|147698685|SUPERIORITY||Hazard Ratio (HR)|0.75||||1e-08|TWO_SIDED|95.0|0.68|0.83||The 2-sided alpha level for the primary analysis was adjusted to 0.0437 from 0.05 to account for the two interim analyses based on a group sequential design with O'Brien-Fleming boundaries generated using the Lan-DeMets alpha-spending function.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region||||0.83|0.68|0.00000001
73884053|NCT04576988|147301929|OTHER||Treatment difference|-441.6|||<|0.001|TWO_SIDED|95.0|-573.54|-309.61||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-309.61|-573.54|<.001
74073273|NCT01492361|147698686|SUPERIORITY||Hazard Ratio (HR)|0.74||||6e-07|TWO_SIDED|95.0|0.65|0.83||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.83|0.65|0.0000006
74073274|NCT01492361|147698687|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.0001|TWO_SIDED|95.0|0.66|0.86||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.86|0.66|<0.0001
73884054|NCT04576988|147301930|OTHER|A 2-sided p-value was calculated using CMH method with WHO FC II/III and background PAH therapy as strata.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73884055|NCT04576988|147301931|OTHER|A 2-sided p-value was calculated using Log rank test with WHO FC II/III and background PAH therapy as strata.|Hazard Ratio (HR)|0.163|||<|0.001|TWO_SIDED|95.0|0.076|0.347|||Log Rank||Cox proportional hazard model was used to generate hazard ratio (HR) and 95% CI was reported with treatment group as the covariate stratified by the WHO FC II/III and background PAH therapy.|||0.347|0.076|<0.001
74073275|NCT01492361|147698688|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.81||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.81|0.58|<0.0001
74073276|NCT01492361|147698689|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.55|0.78||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.78|0.55|<0.0001
74073277|NCT01492361|147698690|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0315|TWO_SIDED|95.0|0.66|0.98||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.98|0.66|0.0315
74073278|NCT01492361|147698691|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0018|TWO_SIDED|95.0|0.53|0.87||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.87|0.53|0.0018
74073279|NCT01492361|147698692|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0129|TWO_SIDED|95.0|0.55|0.93||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.93|0.55|0.0129
74073280|NCT01492361|147698693|SUPERIORITY||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.86|0.69|<0.0001
74073281|NCT01492361|147698694|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0915|TWO_SIDED|95.0|0.74|1.02||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||1.02|0.74|0.0915
74073282|NCT03765502|147698695|SUPERIORITY||||||<|0.0001|||||||McNemar|Crossover design: paired test||||||<.0001
74073283|NCT03765502|147698696|SUPERIORITY||||||<|0.0001|||||||McNemar|Crossover design: paired test||||||<.0001
74073284|NCT03227445|147698730|SUPERIORITY||Odds Ratio (OR)|6.88|||<|0.001|TWO_SIDED|95.0|1.97|54.28|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||"There are three intercurrent events identified which could impact upon the estimand of interest:~* The participant could withdraw from randomised study device sequence and therefore withdraw from the study~* The participant could change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER; these subjects should have been withdrawn from the study according to the protocol.~* The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol.~Rescue Medication use and change to maintenance COPD medication which is not delivered via ELLIPTA, DISKUS or HANDIHALER are not considered intercurrent events"|54.28|1.97|<0.001
74073285|NCT03227445|147698732|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)||||||<0.001
74073286|NCT03227445|147698737|SUPERIORITY||Odds Ratio (OR)|8.85|||<|0.001|TWO_SIDED|95.0|3.45||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||||3.45|<0.001
74073287|NCT03227445|147698738|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Estimand: Composite)||||||<0.001
74073288|NCT03227445|147698739|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)||||||<0.001
74073289|NCT03227445|147698740|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Composite Estimand)||||||<0.001
74073290|NCT03227445|147698741|SUPERIORITY||Odds Ratio (OR)|6.06|||<|0.001|TWO_SIDED|95.0|2.08|24.55|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.|||24.55|2.08|<0.001
74073291|NCT00755196|147698742|SUPERIORITY_OR_OTHER|||||||0.23|||||||2-sided sign test|||||||0.23
74073292|NCT01703832|147698744|SUPERIORITY_OR_OTHER|||||||0.1233||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.1233
74073293|NCT01703832|147698745|SUPERIORITY_OR_OTHER|||||||0.5153||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.5153
74073294|NCT00243932|147698765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||95.0|||||futility (non-superiority)|||Null hypothesis: 2,700mg CoQ10 is at least 20% superior to placebo.||||0.14
74073295|NCT03247556|147698772|SUPERIORITY||Least Square Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.93||0.0082|TWO_SIDED|95.0|-8.9|-1.3|||Mixed Model for Repeated Measures|||||-1.3|-8.9|0.0082
74073296|NCT03247556|147698772|SUPERIORITY||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.93||0.0712|TWO_SIDED|95.0|-7.3|0.3|||Mixed Model for Repeated Measures|||||0.3|-7.3|0.0712
74073297|NCT03247556|147698773|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0051|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.1|-0.8|0.0051
74073298|NCT03247556|147698773|SUPERIORITY||Least Square Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0995|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||0.1|-0.6|0.0995
74073299|NCT03247556|147698774|SUPERIORITY||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.26||0.1377|TWO_SIDED|95.0|-4.3|0.6|||ANCOVA|||||0.6|-4.3|0.1377
74073300|NCT03247556|147698774|SUPERIORITY||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.25||0.313|TWO_SIDED|95.0|-3.7|1.2|||ANCOVA|||||1.2|-3.7|0.3130
74073301|NCT03247556|147698775|SUPERIORITY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.049||0.0698|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||||0.01|-0.19|0.0698
74073302|NCT03247556|147698775|SUPERIORITY||Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9756|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.10|-0.10|0.9756
74073303|NCT03247556|147698776|SUPERIORITY||Risk Difference (RD)|15.3||||0.0349|TWO_SIDED|95.0|1.3|29.3|||Regression, Logistic|||||29.3|1.3|0.0349
74073304|NCT03247556|147698776|SUPERIORITY||Risk Difference (RD)|13.1||||0.0698|TWO_SIDED|95.0|-0.9|27.0|||Regression, Logistic|||||27.0|-0.9|0.0698
74073305|NCT03247556|147698777|SUPERIORITY||Least Square Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|4.76||0.1259|TWO_SIDED|95.0|-16.6|2.0|||ANCOVA|||||2.0|-16.6|0.1259
74073306|NCT03247556|147698777|SUPERIORITY||Least Square Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|4.78||0.7417|TWO_SIDED|95.0|-7.8|10.9|||ANCOVA|||||10.9|-7.8|0.7417
74073307|NCT03247556|147698778|SUPERIORITY||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.97||0.0484|TWO_SIDED|95.0|-3.8|0.0|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.0|-3.8|0.0484
74073308|NCT03247556|147698778|SUPERIORITY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.96||0.2084|TWO_SIDED|95.0|-3.1|0.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||0.7|-3.1|0.2084
74073309|NCT03247556|147698778|SUPERIORITY||Least Square Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.06||0.0042|TWO_SIDED|95.0|-5.1|-1.0|||ANCOVA|||This analysis pertains to the Inattention subscale score||-1.0|-5.1|0.0042
74073310|NCT03247556|147698778|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.06||0.1392|TWO_SIDED|95.0|-3.6|0.5|||ANCOVA|||This analysis pertains to the Inattention subscale score||0.5|-3.6|0.1392
74073311|NCT03247556|147698779|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.07||0.381|TWO_SIDED|95.0|-3.0|1.2|||ANCOVA|||||1.2|-3.0|0.3810
74073312|NCT03247556|147698779|SUPERIORITY||Least Square Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.08||0.0432|TWO_SIDED|95.0|-4.3|-0.1|||ANCOVA|||||-0.1|-4.3|0.0432
74073313|NCT03247556|147698780|SUPERIORITY|||||||0.1433|||||||Chi-squared|||This analysis pertains to Week 1||||0.1433
74073314|NCT03247556|147698780|SUPERIORITY|||||||0.0114|||||||Chi-squared|||This analysis pertains to Week 2||||0.0114
74073315|NCT03247556|147698780|SUPERIORITY|||||||0.0008|||||||Chi-squared|||This analysis pertains to Week 3||||0.0008
74073316|NCT03247556|147698780|SUPERIORITY|||||||0.0197|||||||Chi-squared|||This analysis pertains to Week 4||||0.0197
74073317|NCT03247556|147698780|SUPERIORITY|||||||0.0573|||||||Chi-squared|||This analysis pertains to Week 5||||0.0573
74073318|NCT03247556|147698780|SUPERIORITY|||||||0.0105|||||||Chi-squared|||This analysis pertains to Week 6||||0.0105
74073319|NCT03247556|147698780|SUPERIORITY|||||||0.0004|||||||Chi-squared|||This analysis pertains to Week 7||||0.0004
74073320|NCT03247556|147698780|SUPERIORITY|||||||0.2573|||||||Chi-squared|||This analysis pertains to Week 1||||0.2573
74073321|NCT03247556|147698780|SUPERIORITY|||||||0.165|||||||Chi-squared|||This analysis pertains to Week 2||||0.1650
74073322|NCT03247556|147698780|SUPERIORITY|||||||0.0372|||||||Chi-squared|||This analysis pertains to Week 3||||0.0372
74073323|NCT03247556|147698780|SUPERIORITY|||||||0.1711|||||||Chi-squared|||This analysis pertains to Week 4||||0.1711
74073324|NCT03247556|147698780|SUPERIORITY|||||||0.1428|||||||Chi-squared|||This analysis pertains to Week 5||||0.1428
74073325|NCT03247556|147698780|SUPERIORITY|||||||0.2148|||||||Chi-squared|||This analysis pertains to Week 6||||0.2148
74073326|NCT03247556|147698780|SUPERIORITY|||||||0.0662|||||||Chi-squared|||This analysis pertains to Week 7||||0.0662
74073327|NCT03952143|147698781|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.07||||0.321|TWO_SIDED|95.0|-0.07|0.21|||Mixed Models Analysis|||||0.21|-0.07|0.321
74073328|NCT03952143|147698782|SUPERIORITY||LS Mean Difference|-14.6|||<|0.001|TWO_SIDED|95.0|-21.9|-7.4|||ANCOVA|||||-7.4|-21.9|<0.001
74073329|NCT03952143|147698783|SUPERIORITY||LS Mean Difference|-21.8|||<|0.001|TWO_SIDED|95.0|-30.9|-12.6|||ANCOVA|||||-12.6|-30.9|<0.001
74073330|NCT03952143|147698784|SUPERIORITY||Relative rate|0.26|||||TWO_SIDED|95.0|0.02|2.86||||||||2.86|0.02|
74073331|NCT03952143|147698785|SUPERIORITY||Relative rate|0.9|||||TWO_SIDED|95.0|0.49|1.66||||||For ≤30 minutes post meal||1.66|0.49|
74073332|NCT03952143|147698785|SUPERIORITY||Relative rate|1.35|||||TWO_SIDED|95.0|0.79|2.31||||||For ≤ 1 hour post meal||2.31|0.79|
74073333|NCT03952143|147698785|SUPERIORITY||Relative rate|1.6|||||TWO_SIDED|95.0|1.06|2.42||||||For \>1 to ≤2 hours post meal||2.42|1.06|
73884056|NCT04576988|147301932|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|A 2-sided p-value was calculated using Cochran-Mantel-Haenszel (CMH) method with WHO FC II/III and background PAH therapy as strata.||||||<0.001
74073334|NCT03952143|147698785|SUPERIORITY||Relative rate|1.53|||||TWO_SIDED|95.0|1.05|2.23||||||For ≤2 hours post meal||2.23|1.05|
74073335|NCT03952143|147698785|SUPERIORITY||Relative rate|0.97|||||TWO_SIDED|95.0|0.69|1.39||||||For \>2 to ≤4 hours post meal||1.39|0.69|
74073336|NCT03952143|147698785|SUPERIORITY||Relative rate|1.15|||||TWO_SIDED|95.0|0.84|1.57||||||For ≤4 hours post meal||1.57|0.84|
74073337|NCT03952143|147698786|SUPERIORITY||LS Mean Difference|-0.29|||||TWO_SIDED|95.0|-1.1|0.53||||||||0.53|-1.10|
74073338|NCT03952143|147698787|SUPERIORITY||LS Mean Difference|2.2|||||TWO_SIDED|95.0|-2.8|7.2||||||For Morning Premeal||7.2|-2.8|
74073339|NCT03952143|147698787|SUPERIORITY||LS Mean Difference|-5.3|||||TWO_SIDED|95.0|-12.6|2.0||||||For Morning 1-hour Postmeal||2.0|-12.6|
74073340|NCT03952143|147698787|SUPERIORITY||LS Mean Difference|-5.4|||||TWO_SIDED|95.0|-12.5|1.7||||||For Morning 2-hour Postmeal||1.7|-12.5|
74073341|NCT03952143|147698787|SUPERIORITY||LS Mean Difference|4.2|||||TWO_SIDED|95.0|-1.8|10.1||||||For Midday Premeal||10.1|-1.8|
74073342|NCT03952143|147698787|SUPERIORITY||LS Mean Difference|1.2|||||TWO_SIDED|95.0|-5.7|8.1||||||For Midday 1-hour Postmeal||8.1|-5.7|
74073343|NCT03952143|147698787|SUPERIORITY||LS Mean Difference|1.9|||||TWO_SIDED|95.0|-5.1|8.9||||||For Midday 2-hour Postmeal||8.9|-5.1|
74073344|NCT03952143|147698787|SUPERIORITY||LS Mean Difference|14.1|||||TWO_SIDED|95.0|7.6|20.6||||||For Evening Premeal||20.6|7.6|
74073345|NCT03952143|147698787|SUPERIORITY||LS Mean Difference|2.0|||||TWO_SIDED|95.0|-5.1|9.1||||||For Evening 1-hour Postmeal||9.1|-5.1|
74073346|NCT03952143|147698787|SUPERIORITY||LS Mean Difference|-0.2|||||TWO_SIDED|95.0|-7.3|6.8||||||For Evening 2-hour Postmeal||6.8|-7.3|
74073347|NCT03952143|147698787|SUPERIORITY||LS Mean Difference|1.7|||||TWO_SIDED|95.0|-4.7|8.1||||||For Bedtime||8.1|-4.7|
74073348|NCT03952143|147698788|SUPERIORITY||LS Mean Difference|2.8|||||TWO_SIDED|95.0|0.1|5.4||||||For Total Daily Insulin Dose||5.4|0.1|
74073349|NCT03952143|147698788|SUPERIORITY||LS Mean Difference|0.8|||||TWO_SIDED|95.0|0.0|1.5||||||For Daily Basal Insulin Dose||1.5|0.0|
74073350|NCT03952143|147698788|SUPERIORITY||LS Mean Difference|2.0|||||TWO_SIDED|95.0|-0.5|4.5||||||For Daily Prandial Insulin Dose||4.5|-0.5|
74073351|NCT03952143|147698789|SUPERIORITY||Odds Ratio (OR)|1.02||||0.924|TWO_SIDED|95.0|0.69|1.52|||Regression, Logistic|||For HbA1c \< 7%||1.52|0.69|0.924
74073352|NCT03952143|147698789|SUPERIORITY||Odds Ratio (OR)|0.98||||0.908|TWO_SIDED|95.0|0.64|1.49|||Regression, Logistic|||For HbA1c ≤6.5%||1.49|0.64|0.908
74073353|NCT04421508|147698790|SUPERIORITY||Odds Ratio (OR)|0.36||||0.6316|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.6316
74073354|NCT04421508|147698790|SUPERIORITY||Odds Ratio (OR)|1.502||||0.4127|TWO_SIDED|95.0|0.567|3.977||Odds ratio, 95% CI and p-value are from a logistic regression model modelling the response using the covariates treatment, age, number of co-morbidities and baseline oxygem level|Regression, Logistic|||||3.977|0.567|0.4127
74073355|NCT04421508|147698798|SUPERIORITY|||||||0.6635|||||||Chi-squared|||||||0.6635
74073356|NCT04638153|147699022|OTHER||least square mean difference|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Month 3|Results based on Mixed-Effect Repeated Measures (MMRM) analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.6|-0.2|
74073357|NCT04638153|147699022|OTHER||Least square mean difference|0.5|||||TWO_SIDED|95.0|0.1|0.9|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.9|0.1|
74073358|NCT04638153|147699022|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-0.7|0.1|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.7|
74073359|NCT04638153|147699022|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.1|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.4|
74073360|NCT04638153|147699022|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.4|
73884057|NCT04576988|147301933|OTHER||Treatment difference|-0.26||||0.01|TWO_SIDED|95.0|-0.49|-0.04||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-0.040|-0.490|0.010
74073361|NCT04638153|147699022|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.4|
74073362|NCT04638153|147699022|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
74073363|NCT04638153|147699022|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
74073364|NCT04638153|147699022|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
74073365|NCT04638153|147699022|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
74073366|NCT04638153|147699022|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.3|-0.2|
73884058|NCT04576988|147301934|OTHER||Treatment difference|-0.13||||0.028|TWO_SIDED|95.0|-0.256|-0.014||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-0.014|-0.256|0.028
73884059|NCT04576988|147301935|OTHER||Treatment difference|-0.16||||0.156|TWO_SIDED|95.0|-0.399|0.084||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||0.084|-0.399|0.156
73884060|NCT00617734|147301936|SUPERIORITY_OR_OTHER|||||||0.0667|||||||Log Rank|||||||0.0667
73884061|NCT00617734|147301937|SUPERIORITY_OR_OTHER|||||||0.1935|||||||Fisher Exact|||||||0.1935
73884062|NCT00617734|147301939|SUPERIORITY_OR_OTHER|||||||0.7455|||||||Log Rank|||||||0.7455
74073367|NCT04638153|147699022|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.1|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.4|
74073368|NCT04638153|147699032|OTHER||Least square mean difference|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.2|-0.5|
74073369|NCT04638153|147699032|OTHER||Least square mean difference|1.0|||||TWO_SIDED|95.0|0.2|1.8|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.8|0.2|
74073370|NCT04638153|147699032|OTHER||Least square mean difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.1|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-1.5|
74073371|NCT04638153|147699032|OTHER||Least square mean difference|-0.5|||||TWO_SIDED|95.0|-1.6|0.6|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.6|-1.6|
74073372|NCT04638153|147699032|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-0.4|1.9|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.9|-0.4|
74073373|NCT04638153|147699032|OTHER||Least square mean difference|-1.2|||||TWO_SIDED|95.0|-2.3|-0.1|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||-0.1|-2.3|
74073374|NCT04638153|147699032|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.8|0.7|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.7|-0.8|
74073375|NCT04638153|147699032|OTHER||Least square mean difference|0.6|||||TWO_SIDED|95.0|-0.2|1.5|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.5|-0.2|
73888356|NCT02683577|147309569|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.39|||||TWO_SIDED|90.0|1.45|3.94|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.||3.94|1.45|
74073376|NCT04638153|147699032|OTHER||Least square mean difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-1.5|
74073377|NCT04638153|147699032|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-1.3|1.5|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.5|-1.3|
74073378|NCT04638153|147699032|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-1.4|2.8|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||2.8|-1.4|
74073379|NCT04638153|147699032|OTHER||Least square mean difference|-0.6|||||TWO_SIDED|95.0|-2.6|1.4|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.4|-2.6|
74073380|NCT01973348|147699044|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 12 subjects per group has been shown to be effective for estimating within-group means and variances when little prior data is available.(Julius, 2005) Based on collected data from 34 subjects and effective size difference of 0.1, we reestimate this study as a noninferiority trial with continuous outcome and power calculated as approximately 80%.||||||0.88|||||||t-test, 1 sided|||||||0.88
74073381|NCT02458469|147699068|SUPERIORITY|||||||0.019|||||||ANOVA|||||||0.019
74073382|NCT02458469|147699068|SUPERIORITY|||||||0.015|||||||Student-Newman-Keuls Method|||||||0.015
74073383|NCT02458469|147699068|SUPERIORITY|||||||0.231|||||||Student-Newman-Keuls Method|||||||0.231
74073384|NCT02458469|147699069|SUPERIORITY|||||||0.749|||||||ANOVA|||||||0.749
74073385|NCT03561883|147699070|SUPERIORITY||Least squares (LS) mean difference|-0.062||||0.5566|TWO_SIDED|95.0|-0.27|0.146|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as least squares mean (LSM) change from baseline at Week 8; IW-3718 - placebo based on an mixed models repeated measures (MMRM) model with week (categorical), treatment group, week-by-treatment group and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.146|-0.270|0.5566
74073386|NCT03561883|147699071|SUPERIORITY||LS mean difference|-0.008||||0.9226|TWO_SIDED|95.0|-0.176|0.159|||MMRM|||Treatment difference calculated as LSM change from baseline at Week 8; IW-3718 - placebo based on an MMRM model with week (categorical), treatment group, week-by-treatment group and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.159|-0.176|0.9226
74073387|NCT03561883|147699072|SUPERIORITY||Difference in Responder Rate|1.3|||||TWO_SIDED|95.0|-6.9|9.5|||||95% confidence interval (CI) for Difference in Responder Rates is obtained using the Newcombe CI.|||9.5|-6.9|
74073388|NCT03561883|147699072|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7424|TWO_SIDED|95.0|0.76|1.48|||Cochran-Mantel-Haenszel||Odds Ratio for Response (IW-3718 : placebo)|Treatment difference was calculated as the difference in the responder rates at Week 8; IW-3718 - placebo. The 95% CI for the difference in the responder rates was obtained using the Newcombe CI. P value was based on the odds ratio for the response rate (IW-3718:placebo) obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for baseline esophagitis status and baseline heartburn severity level (\< 3 vs. ≥ 3).||1.48|0.76|0.7424
74073389|NCT03561883|147699073|SUPERIORITY||Difference in Proportion Ratio|1.171||||0.4164|TWO_SIDED|95.0|0.8|1.714||Negative binomial model was used to deal with data overdispersion.|Negative binomial model||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||1.714|0.800|0.4164
74073390|NCT03561883|147699073|OTHER|Negative binomial model was used to deal with data overdispersion|Difference in Proportion Ratio|0.034|||||TWO_SIDED|95.0|-0.054|0.123|||||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||0.123|-0.054|
74073391|NCT06354270|147699074|SUPERIORITY||Adjusted Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.111|<|0.0001|TWO_SIDED|95.0|-1.29|-0.85|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||-0.85|-1.29|<0.0001
74073392|NCT06354270|147699075|SUPERIORITY||Adjusted Mean Difference|36.72|STANDARD_ERROR_OF_MEAN|3.319|<|0.0001|TWO_SIDED|95.0|30.14|43.29|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||43.29|30.14|<0.0001
73884063|NCT00844844|147302037|SUPERIORITY_OR_OTHER||LS mean change from baseline|65.18|||<|0.0001|TWO_SIDED|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols:C08-002A (adult) and C08-002B (Adolescent), a similar protocol, for patients \<18 years with aHUS.||93.36|37.01|<0.0001
74073393|NCT06354270|147699076|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.79|-0.46|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||-0.46|-0.79|<0.0001
74073394|NCT06354270|147699077|SUPERIORITY||Adjusted Mean Difference|14.31|STANDARD_ERROR_OF_MEAN|2.128|<|0.0001|TWO_SIDED|95.0|10.09|18.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||18.52|10.09|<0.0001
74073395|NCT06354270|147699078|SUPERIORITY||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.252||0.196|TWO_SIDED|95.0|-0.83|0.17|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 28||0.17|-0.83|0.1960
74073396|NCT06354270|147699078|SUPERIORITY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.344||0.2287|TWO_SIDED|95.0|-1.08|0.28|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 56||0.28|-1.08|0.2287
74073397|NCT06354270|147699078|SUPERIORITY||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.235|TWO_SIDED|95.0|-0.89|0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 28||0.22|-0.89|0.2350
74073398|NCT06354270|147699078|SUPERIORITY||Adjusted Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.328||0.1818|TWO_SIDED|95.0|-1.09|0.21|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 56||0.21|-1.09|0.1818
74073399|NCT06354270|147699078|SUPERIORITY||Adjusted Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.357||0.1316|TWO_SIDED|95.0|-1.25|0.17|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 28||0.17|-1.25|0.1316
74073400|NCT06354270|147699078|SUPERIORITY||Adjusted Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.417||0.0658|TWO_SIDED|95.0|-1.6|0.05|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 56||0.05|-1.60|0.0658
74073401|NCT06354270|147699079|SUPERIORITY||Adjusted Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|4.862||0.8072|TWO_SIDED|95.0|-8.45|10.83|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||10.83|-8.45|0.8072
74073402|NCT06354270|147699079|SUPERIORITY||Adjusted Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|6.175||0.9641|TWO_SIDED|95.0|-11.96|12.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||12.52|-11.96|0.9641
74073403|NCT06354270|147699080|SUPERIORITY||Adjusted Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.75||0.2538|TWO_SIDED|95.0|-0.63|2.35|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.35|-0.63|0.2538
74073404|NCT06354270|147699080|SUPERIORITY||Adjusted Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.922||0.7311|TWO_SIDED|95.0|-2.15|1.51|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||1.51|-2.15|0.7311
74073405|NCT06354270|147699081|SUPERIORITY||Adjusted Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|2.162||0.7202|TWO_SIDED|95.0|-3.51|5.06|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||5.06|-3.51|0.7202
74073406|NCT06354270|147699081|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|2.532||0.9859|TWO_SIDED|95.0|-5.06|4.98|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||4.98|-5.06|0.9859
74073407|NCT06354270|147699082|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.78||0.5586|TWO_SIDED|95.0|-2.0|1.09|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||1.09|-2.00|0.5586
74073408|NCT06354270|147699082|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.961||0.873|TWO_SIDED|95.0|-2.06|1.75|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||1.75|-2.06|0.8730
74073409|NCT06354270|147699083|SUPERIORITY||Adjusted Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|1.383||0.6191|TWO_SIDED|95.0|-3.43|2.05|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.05|-3.43|0.6191
74073410|NCT06354270|147699083|SUPERIORITY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.669||0.9521|TWO_SIDED|95.0|-3.41|3.21|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||3.21|-3.41|0.9521
74073411|NCT06354270|147699084|SUPERIORITY||Adjusted Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.795||0.3887|TWO_SIDED|95.0|-0.89|2.26|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.26|-0.89|0.3887
74073412|NCT06354270|147699084|SUPERIORITY||Adjusted Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.989||0.373|TWO_SIDED|95.0|-1.08|2.84|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||2.84|-1.08|0.3730
74073413|NCT06354270|147699085|SUPERIORITY||Adjusted Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.134||0.1591|TWO_SIDED|95.0|-0.08|0.46|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||0.46|-0.08|0.1591
74073414|NCT06354270|147699085|SUPERIORITY||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.144||0.3429|TWO_SIDED|95.0|-0.15|0.42|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||0.42|-0.15|0.3429
74073415|NCT06354270|147699086|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.411||0.136|TWO_SIDED|95.0|-1.43|0.2|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||0.20|-1.43|0.1360
74073416|NCT06354270|147699086|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.431||0.2914|TWO_SIDED|95.0|-1.31|0.4|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||0.40|-1.31|0.2914
74073417|NCT01939197|147699087|NON_INFERIORITY|The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).|||||||||||||||||"The historical SVR rate, as reported in the PHOTON-1 study, for sofosbuvir and RBV in HCV/HIV-1 coinfected adults is 76% (87/114) with a 95% confidence interval of (67%, 84%).~Reference: Sulkowski MS, Naggie S, Lalezari J, et al. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014;312(4):353-61."|||
74073418|NCT01939197|147699088|OTHER|||||||1|||||||Fisher Exact|||||||1.000
74073419|NCT01939197|147699089|OTHER||||||||||||||||||"The Fisher exact test was performed as prespecified on the SAP but the p-value couldn't be calculated because SVR12 rates in both arms were 100%, hence p-value appeared as not available."|||
74073420|NCT00113425|147699113|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.01
74073421|NCT00113425|147699114|SUPERIORITY_OR_OTHER|||||||0.43|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.43
74073422|NCT00113425|147699115|SUPERIORITY_OR_OTHER|||||||0.79|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.79
74073423|NCT00113425|147699116|SUPERIORITY_OR_OTHER|||||||0.1|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.10
74073424|NCT00113425|147699117|SUPERIORITY_OR_OTHER|||||||0.73|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.73
74073425|NCT00113425|147699118|SUPERIORITY_OR_OTHER|||||||0.02|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.02
74073426|NCT00113425|147699119|SUPERIORITY_OR_OTHER|||||||0.003|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.003
74073427|NCT00113425|147699120|SUPERIORITY_OR_OTHER|||||||0.62|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.62
74073428|NCT00113425|147699121|SUPERIORITY_OR_OTHER|||||||0.85|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.85
74073429|NCT00113425|147699122|SUPERIORITY_OR_OTHER|||||||0.49|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.49
74073430|NCT00113425|147699123|SUPERIORITY_OR_OTHER|||||||0.21|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.21
74073431|NCT00113425|147699124|SUPERIORITY_OR_OTHER|||||||0.27|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.27
74073432|NCT00113425|147699125|SUPERIORITY_OR_OTHER|||||||0.04|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.04
74073433|NCT00113425|147699126|SUPERIORITY_OR_OTHER|||||||0.01|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.01
74073434|NCT04526210|147699232|OTHER||Geometric least square (LS) mean ratio|0.98|||||TWO_SIDED|90.0|0.9415|1.0205||||||||1.0205|0.9415|
74073435|NCT04526210|147699233|OTHER||Geometric LS mean ratio|0.978|||||TWO_SIDED|90.0|0.9344|1.0244||||||||1.0244|0.9344|
74073436|NCT04526210|147699234|OTHER||Geometric LS mean ratio|0.981|||||TWO_SIDED|90.0|0.9368|1.0269||||||||1.0269|0.9368|
74073437|NCT00090857|147699245|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.15
74073438|NCT00090857|147699246|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.70
74073439|NCT00090857|147699247|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.03
74073440|NCT00090857|147699248|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.06
74073441|NCT00090857|147699249|SUPERIORITY_OR_OTHER|||||||0.38|||||||Fisher Exact|||||||0.38
74073442|NCT00090857|147699250|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
74073443|NCT00090857|147699251|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||||||0.20
74073444|NCT00090857|147699252|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||||||.88
74073445|NCT00090857|147699253|SUPERIORITY_OR_OTHER|||||||0.27|||||||Fisher Exact|||||||0.27
74073446|NCT00090857|147699254|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||||||.60
74073447|NCT00090857|147699255|SUPERIORITY_OR_OTHER|||||||0.58|||||||Fisher Exact|||||||.58
74073448|NCT00090857|147699256|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||.49
74073449|NCT05097326|147699260|OTHER|||||||0.44||||||a p-value \<0.05 would be considered statistically significant|Fisher Exact|||Analysis of total contractions||||0.44
74073450|NCT05097326|147699260|OTHER|||||||0.02||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Analysis of contractions per hour||||0.02
74073451|NCT05097326|147699261|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Comparison at 12 hours after labor induction||||0.04
74073452|NCT05097326|147699261|OTHER|||||||0.17||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Comparison of uterine tachysystole of total labor duration||||0.17
74073453|NCT05097326|147699262|OTHER|||||||0.63||||||a p-value \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.63
74073454|NCT05097326|147699263|OTHER|||||||0.01||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.01
74073455|NCT05097326|147699264|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison at complete cervical dilation||||0.04
74073456|NCT05097326|147699265|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison at postpartum transfer||||0.04
74073457|NCT05097326|147699266|OTHER|||||||0.68||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||0.68
74073458|NCT05097326|147699267|OTHER|||||||1||||||A p-value of \<0.05 would be considered significant.|Fisher Exact|||||||1
74073459|NCT05097326|147699268|OTHER|||||||1||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||1
74073460|NCT05097326|147699269|OTHER|||||||0.9||||||A p-value \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.90
74073461|NCT05097326|147699270|OTHER|||||||0.17||||||a p-value \<0.05 would be considered statistically significant|Fisher Exact|||1 minute APGAR score||||0.17
74073462|NCT05097326|147699270|OTHER|||||||1||||||A p-value of \<0.05 would be statistically significant.|Fisher Exact|||APGAR score at 5 minutes||||1
74073463|NCT05097326|147699271|OTHER|||||||0.22||||||A p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||0.22
74073464|NCT00437658|147699319|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-0.3||||0.963|TWO_SIDED|95.0|-13.4|12.7|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC|||12.7|-13.4|0.9630
74073465|NCT00437658|147699319|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-12.4||||0.101|TWO_SIDED|95.0|-26.7|1.8|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC|||1.8|-26.7|0.1010
74073466|NCT00437658|147699320|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|9.5||||0.2048|TWO_SIDED|95.0|-5.2|24.2|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC|||24.2|-5.2|0.2048
74073467|NCT00437658|147699320|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|0.5||||0.9544|TWO_SIDED|95.0|-15.1|16.0|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC|||16.0|-15.1|0.9544
74073468|NCT00437658|147699323|OTHER||Least squares mean|-5.5|||<|0.0001|TWO_SIDED|95.0|-6.2|-4.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-4.8|-6.2|< 0.0001
74073469|NCT00437658|147699323|OTHER||Least squares mean|-5.2|||<|0.0001|TWO_SIDED|95.0|-5.8|-4.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-4.5|-5.8|< 0.0001
74073470|NCT00437658|147699323|OTHER||Least squares mean|-5.3|||<|0.0001|TWO_SIDED|95.0|-6.0|-4.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-4.6|-6.0|< 0.0001
74073471|NCT00437658|147699324|OTHER||Least squares mean|-4.6|||<|0.0001|TWO_SIDED|95.0|-5.1|-4.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-4.0|-5.1|<0.0001
74073472|NCT00437658|147699324|OTHER||Least squares mean|-4.4|||<|0.0001|TWO_SIDED|95.0|-5.0|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-3.9|-5.0|<0.0001
74073473|NCT00437658|147699324|OTHER||Least squares mean|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-3.9|-5.1|< 0.0001
73884064|NCT00844844|147302038|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|82.0|||||TWO_SIDED|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||96|57|
73884065|NCT00844844|147302039|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
73884066|NCT00844844|147302040|SUPERIORITY_OR_OTHER||Percent of complete TMA response|65.0|||||TWO_SIDED|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||86|38|
73884067|NCT00844844|147302041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
73884068|NCT00844844|147302042|SUPERIORITY_OR_OTHER||LS mean change from baseline|111.62|||<|0.0001|TWO_SIDED|95.0|98.12|125.13|||ANOVA|Change from baseline was analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||125.13|98.12|<0.0001
73884069|NCT00844844|147302043|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
73884070|NCT00844844|147302044|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
73884071|NCT00844844|147302045|SUPERIORITY_OR_OTHER||Percent of complete TMA response|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
73884072|NCT00844844|147302046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
73884073|NCT03905096|147302048|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|92.63|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|85.34|100.53|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||100.53|85.34|
73884074|NCT03905096|147302049|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|98.64|STANDARD_DEVIATION|6.9|||TWO_SIDED|90.0|93.21|104.39|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||104.39|93.21|
73884075|NCT03905096|147302050|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|98.48|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|90.74|106.88|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||106.88|90.74|
73884076|NCT03905096|147302051|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|100.15|STANDARD_DEVIATION|14.4|||TWO_SIDED|90.0|89.01|112.68|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||112.68|89.01|
73884077|NCT03905096|147302052|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|94.77|STANDARD_DEVIATION|10.6|||TWO_SIDED|90.0|88.36|101.64|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||101.64|88.36|
73884078|NCT03905096|147302053|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|100.06|STANDARD_DEVIATION|6.9|||TWO_SIDED|90.0|94.56|105.87|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||105.87|94.56|
73884079|NCT02016781|147302057|SUPERIORITY|||||||0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|Wald test of difference in adjusted OS estimates.||The null hypothesis is that the rates of three-year OS are the same for both treatments. The results posted are from the interim analysis per protocol study design.||||0.0001
73884080|NCT02016781|147302057|SUPERIORITY|||||||0.3345||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between response to hypomethylating therapy and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of response to hypomethylating therapy (No Response to Hypomethylation vs. Any Response or Hematologic Improvement to Hypomethylation vs. No Prior Hypomethylation) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.3345
73884081|NCT02016781|147302057|SUPERIORITY|||||||0.7328||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between patient age and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of patient age (\< vs. \>= 65) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.7328
73884082|NCT02016781|147302057|SUPERIORITY|||||||0.6261||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between disease duration and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of disease duration (less than vs. 3 months or more) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.6261
73884083|NCT02016781|147302057|SUPERIORITY|||||||0.4134||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between IPSS score and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of IPSS score (Intermediate-2 vs. High) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4134
73884084|NCT02016781|147302057|SUPERIORITY|||||||0.3147||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between IPSS-R score and treatment assignment in regression model.||Statistical Analysis 6: This subgroup analysis investigated the differential impact of IPSS-R score (Very Low, Low, or Intermediate vs. High vs. Very High) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.3147
74073474|NCT00437658|147699325|OTHER||Least squares mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.2|-1.7|< 0.0001
74073475|NCT00437658|147699325|OTHER||Least squares mean|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.2|-1.6|< 0.0001
74073476|NCT00437658|147699325|OTHER||Least squares mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.4|-1.9|< 0.0001
74073477|NCT00437658|147699326|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.9|-1.4|< 0.0001
73884085|NCT02016781|147302058|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year LFS are the same for both treatments.||||0.0030
73884086|NCT02016781|147302058|SUPERIORITY|||||||0.9908||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of response to hypomethylating therapy on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.9908
74073478|NCT00437658|147699326|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|2.0|-1.2|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.2|< 0.0001
74073479|NCT00437658|147699326|OTHER||Least squares mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.5|-1.1|< 0.0001
74073480|NCT00437658|147699327|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-1.0|-1.4|< 0.0001
74073481|NCT00437658|147699327|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-1.0|-1.4|< 0.0001
74073482|NCT00437658|147699327|OTHER||Least squares mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-0.8|-1.3|< 0.0001
74073483|NCT00437658|147699328|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.8|-1.2|< 0.0001
74073484|NCT00437658|147699328|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.8|-1.1|< 0.0001
73884087|NCT02016781|147302058|SUPERIORITY|||||||0.8981||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of patient age (\< or \>= 65) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.8981
74073485|NCT00437658|147699328|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.1|< 0.0001
74073486|NCT00437658|147699329|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.0|< 0.0001
74073487|NCT00437658|147699329|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.1|< 0.0001
74073488|NCT00437658|147699329|OTHER||Least squares mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.6|||t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.6|-0.9|<0.0001
73884088|NCT02016781|147302058|SUPERIORITY|||||||0.1465||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of disease duration (less than vs. 3 months or more) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.1465
73884089|NCT02016781|147302058|SUPERIORITY|Statistical significance was determined using a pre-specified threshold of 0.05.||||||0.4991|||||||pseudo-value regression models|||This subgroup analysis investigated the differential impact of IPSS score (Intermediate-2 vs. High) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4991
74073489|NCT00437658|147699330|OTHER||Least squares mean|-32.3|||<|0.0001|TWO_SIDED|95.0|-39.2|-25.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-25.4|-39.2|< 0.0001
73884090|NCT02016781|147302058|SUPERIORITY|||||||0.4953||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of IPSS-R score on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4953
73884091|NCT02016781|147302059|SUPERIORITY|||||||0.2777||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the FACT-G scores are the same at Enrollment for both treatments.||||0.2777
74073490|NCT00437658|147699330|OTHER||Least squares mean|-32.9|||<|0.0001|TWO_SIDED|95.0|-39.4|-26.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-26.4|-39.4|< 0.0001
74073491|NCT00437658|147699330|OTHER||Least squares mean|-35.8|||<|0.0001|TWO_SIDED|95.0|-43.0|-28.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-28.6|-43.0|< 0.0001
74073492|NCT00437658|147699331|OTHER||Least squares mean|-18.2|||<|0.0001|TWO_SIDED|95.0|-23.3|-13.1||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-13.1|-23.3|< 0.0001
74073493|NCT00437658|147699331|OTHER||Least squares mean|-23.4|||<|0.0001|TWO_SIDED|95.0|-28.3|-18.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-18.5|-28.3|< 0.0001
74073494|NCT00437658|147699331|OTHER||Least squares mean|-17.9|||<|0.0001|TWO_SIDED|95.0|-23.1|-12.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-12.7|-23.1|< 0.0001
74073495|NCT02731157|147699348|OTHER||Mean Difference (Final Values)|0.65||||0.95|TWO_SIDED||||||ANOVA|||||||0.95
74073496|NCT05150964|147699357|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05, Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The hearing aid fitting prescription will have no effect on the speech reception thresholds."||||<0.05
74073497|NCT05150964|147699357|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05, Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The ASG setting will have no effect on the speech reception threshold."||||>0.05
74073498|NCT05150964|147699358|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The ASG setting will have no effect on the Word Recognition Scores."||||<0.05
74073499|NCT05150964|147699358|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The presentation level will have no effect on the Word Recognition Scores."||||<0.05
74073500|NCT05150964|147699358|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: Hearing aid prescription will have no effect on the Word Recognition Scores."||||<0.05
74073501|NCT05150964|147699359|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on multi-word recognition scores."||||<0.05
74073502|NCT05150964|147699359|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on multi-word recognition scores."||||>0.05
73884092|NCT02016781|147302059|SUPERIORITY|||||||0.225||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 6 Months for both treatments.||||0.2250
74073503|NCT05150964|147699359|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on multi-word recognition scores."||||>0.05
74073504|NCT05150964|147699360|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Nonword Detection scores."||||<0.05
74073505|NCT05150964|147699360|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on Nonword Detection scores."||||<0.05
74073506|NCT05150964|147699360|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Nonword Detection scores."||||>0.05
74073507|NCT05150964|147699361|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Rapid Word Learning scores."||||>0.05
74073508|NCT05150964|147699361|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Rapid Word Learning scores."||||>0.05
74073509|NCT05150964|147699361|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescripton will have no effect on Rapid Word Learning scores."||||>0.05
74073510|NCT03657160|147699386|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.27|0.73|||Log Rank|||||0.73|0.27|<0.001
74073511|NCT03657160|147699387|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0043|TWO_SIDED|95.0|0.37|0.86|||Log Rank|||||0.86|0.37|0.0043
74073512|NCT03657160|147699388|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0204|TWO_SIDED|95.0|0.39|0.91|||Log Rank|||||0.91|0.39|0.0204
74073513|NCT03657160|147699389|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0668|TWO_SIDED|95.0|0.22|1.04|||Log Rank|||||1.04|0.22|0.0668
74073514|NCT03657160|147699390|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.1458|TWO_SIDED|95.0|0.34|1.17|||Log Rank|||||1.17|0.34|0.1458
74073515|NCT03657160|147699391|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0105|TWO_SIDED|95.0|0.46|0.91|||Log Rank|||||0.91|0.46|0.0105
74073516|NCT04006171|147699398|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
74073517|NCT04006171|147699399|OTHER|||||||0.004|||||||Roc curve|||||||0.004
74073518|NCT04006171|147699400|OTHER|||||||0.171||||||p value for FSH|Wilcoxon (Mann-Whitney)|for FSH||||||0.171
74073519|NCT04006171|147699400|OTHER|||||||0.176||||||p value for LH|Wilcoxon (Mann-Whitney)|for LH||||||0.176
74073520|NCT04006171|147699401|OTHER|||||||0.306|||||||Wilcoxon (Mann-Whitney)|||||||0.306
74073521|NCT04006171|147699402|OTHER|||||||0.795|||||||Wilcoxon (Mann-Whitney)|||||||0.795
74073522|NCT04006171|147699403|OTHER|||||||0.852|||||||t-test, 2 sided|||||||0.852
74073523|NCT04006171|147699404|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74073524|NCT04006171|147699405|OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||||||0.277
74073525|NCT04006171|147699406|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
74073526|NCT04006171|147699407|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74073527|NCT04006171|147699408|OTHER|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
74073528|NCT04006171|147699409|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74073529|NCT04006171|147699410|OTHER|||||||0.947||||||for serum glucose|Wilcoxon (Mann-Whitney)|for serum glucose||||||0.947
74073530|NCT04006171|147699410|OTHER|||||||0.906||||||for total cholesterol|Wilcoxon (Mann-Whitney)|for total cholesterol||||||0.906
74073531|NCT04006171|147699410|OTHER|||||||0.428||||||for triglycerides|Wilcoxon (Mann-Whitney)|for triglycerides||||||0.428
74073532|NCT04006171|147699411|OTHER|||||||0.114||||||for high density lipoprotein|t-test, 2 sided|||||||0.114
74073533|NCT04006171|147699411|OTHER|||||||0.504||||||for low density lipoprotein|Wilcoxon (Mann-Whitney)|for low density lipoprotein||||||0.504
74073534|NCT04006171|147699412|OTHER|||||||0.713|||||||Wilcoxon (Mann-Whitney)|||||||0.713
74073535|NCT04006171|147699413|OTHER|||||||0.886|||||||Wilcoxon (Mann-Whitney)|||||||0.886
74073536|NCT00440557|147699420|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.17|STANDARD_ERROR_OF_MEAN|0.106||||95.0|-0.38|0.037||This comparison between QW and TIW was performed prior to comparing Q2W with TIW in the statistical analysis 2 according to a planned stepdown procedure for controlling multiplicity.||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment (tX) through Week 22 in the QW group is not lower than that of the TIW group by more than 1 g/dL.||0.037|-0.380|
74073537|NCT00440557|147699420|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.43|STANDARD_ERROR_OF_MEAN|0.107||||95.0|-0.641|-0.221||Since the non-inferiority was declared in the statistical analysis 1, this comparison between Q2W and TIW was then performed according to a planned stepdown procedure for controlling multiplicity.||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment through Week 22 in the Q2W group is not lower than that of the TIW group by more than 1 g/dL.||-0.221|-0.641|
74073538|NCT00440557|147699421|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-7.8||||||95.0|-17.2|1.7||||||||1.7|-17.2|
73884093|NCT02016781|147302059|SUPERIORITY|||||||0.1048||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 12 Months for both treatments.||||0.1048
73884094|NCT02016781|147302059|SUPERIORITY|||||||0.0888||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 18 Months for both treatments.||||0.0888
74073539|NCT00440557|147699421|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-15.0||||||95.0|-25.0|-5.0||||||||-5.0|-25.0|
74073540|NCT00440557|147699422|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.26||||||95.0|-0.564|0.043|||ANOVA|||||0.043|-0.564|
74073541|NCT00440557|147699422|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.45||||||95.0|-0.755|-0.147|||ANOVA|||||-0.147|-0.755|
74073542|NCT00440557|147699423|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-3.9||||||95.0|-9.5|1.6||||||||1.6|-9.5|
74073543|NCT00440557|147699423|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-5.5||||||95.0|-11.4|0.3||||||||0.3|-11.4|
74073544|NCT00440557|147699424|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-2.7||||||95.0|-14.2|8.7||||||||8.7|-14.2|
74073545|NCT00440557|147699424|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-9.9||||||95.0|-21.7|1.8||||||||1.8|-21.7|
74073546|NCT00440557|147699425|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|2.6||||||95.0|-9.6|14.8||||||||14.8|-9.6|
74073547|NCT00440557|147699425|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-3.0||||||95.0|-15.0|9.0||||||||9.0|-15.0|
74073548|NCT00440557|147699426|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|0.03||||||95.0|-0.21|0.27|||ANOVA|||||0.270|-0.210|
74073549|NCT00440557|147699426|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.07||||||95.0|-0.315|0.166|||ANOVA|||||0.166|-0.315|
74073550|NCT00440557|147699427|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-8.8||||||95.0|-16.0|-1.9||||||||-1.9|-16|
74073551|NCT00440557|147699427|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-10.0||||||95.0|-18.0|-3.2||||||||-3.2|-18.0|
73884095|NCT02016781|147302059|SUPERIORITY|||||||0.5844||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 24 Months for both treatments.||||0.5844
74073552|NCT02096718|147699465|SUPERIORITY_OR_OTHER||Ratio of gmeans|122.23|STANDARD_DEVIATION|28.3|||TWO_SIDED|90.0|95.743|156.045|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||156.045|95.743|
74073553|NCT02096718|147699465|SUPERIORITY_OR_OTHER||Ratio of gmeans|149.97|STANDARD_DEVIATION|41.9|||TWO_SIDED|90.0|105.266|213.671|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||213.671|105.266|
74073554|NCT02096718|147699466|SUPERIORITY_OR_OTHER||Ratio of gmeans|101.16|STANDARD_DEVIATION|38.5|||TWO_SIDED|90.0|72.931|140.309|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||140.309|72.931|
73884096|NCT02016781|147302059|SUPERIORITY|||||||0.0344||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 36 Months for both treatments.||||0.0344
73884097|NCT02016781|147302060|SUPERIORITY|||||||0.5583||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the MOS SF-36 PCS scores are the same at Enrollment for both treatments.||||0.5583
74073555|NCT02096718|147699466|SUPERIORITY_OR_OTHER||Ratio of gmeans|121.71|STANDARD_DEVIATION|34.2|||TWO_SIDED|90.0|90.79|163.162|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||163.162|90.790|
74073556|NCT02096718|147699467|SUPERIORITY_OR_OTHER||Ratio of gmeans|122.44|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|96.141|155.928|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||155.928|96.141|
74073557|NCT02096718|147699467|SUPERIORITY_OR_OTHER||Ratio of gmeans|150.08|STANDARD_DEVIATION|41.5|||TWO_SIDED|90.0|105.626|213.25|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||213.250|105.626|
73884098|NCT02016781|147302060|SUPERIORITY|||||||0.669||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 6 Months for both treatments.||||0.6690
73884099|NCT02016781|147302060|SUPERIORITY|||||||0.2089||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 12 Months for both treatments.||||0.2089
73884100|NCT02016781|147302060|SUPERIORITY|||||||0.4343||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 18 Months for both treatments.||||0.4343
73884101|NCT02016781|147302060|SUPERIORITY|||||||0.5942||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 24 Months for both treatments.||||0.5942
73884102|NCT02016781|147302060|SUPERIORITY|||||||0.1615||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 36 Months for both treatments.||||0.1615
73884103|NCT02016781|147302060|SUPERIORITY|||||||0.5659||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the MOS SF-36 MCS scores are the same at Enrollment for both treatments.||||0.5659
73884104|NCT02016781|147302060|SUPERIORITY|||||||0.8555||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 6 Months for both treatments.||||0.8555
73884105|NCT02016781|147302060|SUPERIORITY|||||||0.8995||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 12 Months for both treatments.||||0.8995
73884106|NCT02016781|147302060|SUPERIORITY|||||||0.0105||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 18 Months for both treatments.||||0.0105
73884107|NCT02016781|147302060|SUPERIORITY|||||||0.2596||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 24 Months for both treatments.||||0.2596
73884108|NCT02016781|147302060|SUPERIORITY|||||||0.5022||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 36 Months for both treatments.||||0.5022
73884109|NCT02016781|147302061|SUPERIORITY|||||||0.1768||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the EQ-5D scores are the same at Enrollment for both treatments.||||0.1768
73884110|NCT02016781|147302061|SUPERIORITY|||||||0.8318||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 6 Months for both treatments.||||0.8318
73884111|NCT02016781|147302061|SUPERIORITY|||||||0.4752||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 12 Months for both treatments.||||0.4752
73884112|NCT02016781|147302061|SUPERIORITY|||||||0.5671||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 18 Months for both treatments.||||0.5671
73884113|NCT02016781|147302061|SUPERIORITY|||||||0.3009||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 24 Months for both treatments.||||0.3009
73884114|NCT02016781|147302061|SUPERIORITY|||||||0.3403||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 36 Months for both treatments.||||0.3403
73884115|NCT02016781|147302062|SUPERIORITY||||||<|0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year OS are the same for both treatments in treated population.||||< 0.0001
73884116|NCT02016781|147302063|SUPERIORITY||||||<|0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year LFS are the same for both treatments in treated population.||||< 0.0001
73884117|NCT04886154|147302080|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose\_06 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|4.67|||||TWO_SIDED|97.5|3.38|5.97|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,6-months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||5.97|3.38|
73884118|NCT04886154|147302080|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose\_02 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|-0.17|||||TWO_SIDED|97.5|-1.65|1.3|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||1.30|-1.65|
74073558|NCT03682900|147699468|SUPERIORITY||||||=|0||||||A one tailed test was used, as the intervention is expected to be superior than the control group. The criterion for significance was p \<. 05.|Mixed Models Analysis|There were no adjustments made for multiple comparisons.||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||= .000
73884119|NCT04886154|147302080|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose\_06 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|4.6|||||TWO_SIDED|97.5|3.33|5.89|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,6- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||5.89|3.33|
74073559|NCT03682900|147699469|SUPERIORITY||||||=|0||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition||||= .000
74073560|NCT03682900|147699470|SUPERIORITY||||||=|0.044||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||=.044
74073561|NCT03682900|147699471|SUPERIORITY||||||=|0.033||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for significance is p\<.05.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||=.033
74073562|NCT03682900|147699472|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073563|NCT03682900|147699473|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073564|NCT03682900|147699474|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073565|NCT03682900|147699475|SUPERIORITY||||||<|0.001||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073566|NCT03682900|147699476|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073567|NCT03682900|147699477|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073568|NCT03682900|147699478|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073569|NCT03682900|147699479|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
73884120|NCT04886154|147302080|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose\_02 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|2.01|||||TWO_SIDED|97.5|0.6|3.42|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||3.42|0.60|
73884121|NCT04886154|147302081|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|3.03|||||TWO_SIDED|97.5|-4.21|10.17|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||10.17|-4.21|
73884122|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|4.66|||||TWO_SIDED|97.5|-2.71|11.64|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||11.64|-2.71|
73884123|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|5.48|||||TWO_SIDED|97.5|-0.71|12.25|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||12.25|-0.71|
73884124|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|3.87|||||TWO_SIDED|97.5|-3.7|10.97|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||10.97|-3.70|
73884125|NCT04886154|147302081|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|35.03|||||TWO_SIDED|97.5|25.22|44.75|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||44.75|25.22|
73884126|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|34.16|||||TWO_SIDED|97.5|23.76|44.1|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||44.10|23.76|
73884127|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.88|||||TWO_SIDED|97.5|19.26|40.19|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||40.19|19.26|
73884128|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|33.54|||||TWO_SIDED|97.5|23.09|43.54|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||43.54|23.09|
73884129|NCT04886154|147302081|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|30.88|||||TWO_SIDED|97.5|21.61|40.32|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||40.32|21.61|
73884130|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the MenABCWY-2Gen MenACWY vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.35|||||TWO_SIDED|97.5|19.31|39.08|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||39.08|19.31|
73884131|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.02|||||TWO_SIDED|97.5|19.42|38.67|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||38.67|19.42|
73884132|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|25.13|||||TWO_SIDED|97.5|14.2|35.45|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||35.45|14.20|
74073570|NCT03682900|147699480|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a gneral linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073571|NCT03682900|147699481|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlayzed using a general linear mixed model with students nested within schools and schools within condition.||||<.001
73884133|NCT04886154|147302081|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|33.38|||||TWO_SIDED|97.5|23.08|43.26|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||43.26|23.08|
74073572|NCT03682900|147699482|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. Apriori, a p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed uisng a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073573|NCT03682900|147699483|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is a priori considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear model with students nested within schools and schools nested within condition.||||<.001
74073574|NCT03682900|147699484|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073575|NCT03682900|147699485|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073576|NCT03682900|147699486|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear model mixed model with students nested within schools and schools nested within condition.||||<.001
74073577|NCT03682900|147699487|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073578|NCT03682900|147699488|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schols and schools nested within condition.||||<.001
74073579|NCT03682900|147699489|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
74073580|NCT04448678|147699504|OTHER|||||||0.0401|||||||t-test, 2 sided|||||||0.0401
73888357|NCT02683577|147309569|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.52|||||TWO_SIDED|90.0|2.45|5.03|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.||5.03|2.45|
74073581|NCT04448678|147699505|OTHER|||||||0.0049|||||||t-test, 2 sided|||||||0.0049
74073582|NCT04448678|147699506|OTHER|||||||0.297|||||||t-test, 2 sided|||||||0.297
74073583|NCT02016170|147699512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined). Under the assumption of 0 difference in mean PRU between ticagrelor 90 mg bid MD and prasugrel 10 mg qd MD and a common standard deviation of 60 PRU, a sample size of 24 patients per group allowed for the 95% CI to stay within ± 45 PRU with a 90% power and alpha=0.05.|Mean Difference (Final Values)|-18.0|||||TWO_SIDED|95.0|-41.0|5.0||||||||5|-41|
74073584|NCT02016170|147699513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined).|Mean Difference (Final Values)|-11.0|||||TWO_SIDED|95.0|-18.0|-4.0||||||||-4|-18|
74073585|NCT01993875|147699541|SUPERIORITY|||||||0.129||||||Treatment p-value is from an analysis of co-variance (ANCOVA) using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA|||||||0.1290
74073586|NCT01993875|147699542|SUPERIORITY|||||||0.129||||||Treatment p-value is from an ANCOVA using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA|||||||0.1290
74073587|NCT01993875|147699543|SUPERIORITY|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA|||||||0.2177
74073588|NCT01993875|147699544|SUPERIORITY|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA|||||||0.2177
74073589|NCT01993875|147699545|SUPERIORITY|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline straining score as random effect.|ANCOVA|||||||0.0664
74073590|NCT01993875|147699546|SUPERIORITY|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline mean score as random effect.|ANCOVA|||||||0.0664
73884134|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|28.18|||||TWO_SIDED|97.5|16.61|38.86|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||38.86|16.61|
73884135|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.37|||||TWO_SIDED|97.5|18.67|39.63|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||39.63|18.67|
73884136|NCT04886154|147302081|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|27.21|||||TWO_SIDED|97.5|15.46|38.02|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||38.02|15.46|
73884137|NCT02977403|147302119|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for AB reaction time measures. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. AB reaction times were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-1.948|||||TWO_SIDED|95.0|-20.79|16.894||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in AB, change scores were computed (post-pre = delta). Positive scores represent an increase in AB from pre- to post- intervention. Negative ∆reaction time scores represent a decrease in AB from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in AB following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||16.894|-20.790|
73884138|NCT02977403|147302119|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.952|||||TWO_SIDED|95.0|-35.28|33.377||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||33.377|-35.280|
73884139|NCT02977403|147302120|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficent|0.047|||||TWO_SIDED|95.0|-0.025|0.119||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.119|-0.025|
73884140|NCT02977403|147302120|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.134|||||TWO_SIDED|95.0|-0.288|0.019||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.019|-0.288|
73888358|NCT02683577|147309570|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.26|||||TWO_SIDED|90.0|1.33|3.82|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on ln transformed AUC(0-inf) values for LP-778902.||3.82|1.33|
73888359|NCT02683577|147309570|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.32|||||TWO_SIDED|90.0|2.3|4.8|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-inf) values for LP-778902.||4.80|2.30|
74073591|NCT01874951|147699555|NON_INFERIORITY_OR_EQUIVALENCE|An initial power analysis at the time of protocol development suggested that with 6 patients in each treatment group, we could expect a 79% chance of achieving significance (2-sided p \< 0.05) if the true response rate to low-dose naltrexone (LDN) was 80% and the true placebo response rate was 20%.||||||0.55||||||Threshold of statistical significance is 0.05.|Chi-squared|Chi-squared value was 1.5.||Response rates were based on attaining a reduction in the HAM-D-17 scale of 50% or greater compared to baseline. We hypothesized that naltrexone would produce a significantly greater response rate than placebo.||||0.55
73888513|NCT05465317|147309652|OTHER||Hazard Ratio (HR)|0.74||||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.97|0.57|0.03
74073592|NCT02158936|147699582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||1|TWO_SIDED|95.0|0.21|0.65||One sided p value|Cochran-Mantel-Haenszel|Stratified by Interactive Voice Response System (IVRS) stratification factors||||0.65|0.21|1.000
74073593|NCT02158936|147699583|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.42||||0.164|TWO_SIDED|95.0|0.97|2.08|||Log Rank|||Confidence Intervals estimated using the Brookmeyer-Crowley method. Hazard ratios are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower risk with eltrombopag compared with Placebo. Log-rank test stratified by IVRS stratification factors||2.08|0.97|0.164
74073594|NCT02158936|147699600|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.31|||||TWO_SIDED|90.0|0.99|1.74|||ANOVA|||||1.74|0.990|
74073595|NCT02158936|147699601|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.39|||||TWO_SIDED|90.0|0.97|1.99|||ANOVA|||||1.99|0.970|
74073596|NCT01706926|147699603|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.193|<|0.001|TWO_SIDED|95.0|-1.06|-0.31|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95 percent (%) confidence interval (CI) was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.31|-1.06|<0.001
74073597|NCT01706926|147699603|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.33|-0.58|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.58|-1.33|<0.001
74073598|NCT01706926|147699603|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.193|<|0.001|TWO_SIDED|95.0|-1.6|-0.84|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.84|-1.60|<0.001
74073599|NCT01706926|147699604|SUPERIORITY_OR_OTHER||Percent difference|25.9|||<|0.001|TWO_SIDED|95.0|11.5|40.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||40.3|11.5|<0.001
74073600|NCT01706926|147699604|SUPERIORITY_OR_OTHER||Percent difference|36.5|||<|0.001|TWO_SIDED|95.0|22.5|50.5|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||50.5|22.5|<0.001
74073601|NCT01706926|147699604|SUPERIORITY_OR_OTHER||Percent difference|48.7|||<|0.001|TWO_SIDED|95.0|35.2|62.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||62.3|35.2|<0.001
74073602|NCT01706926|147699611|SUPERIORITY_OR_OTHER||Percent difference|16.0||||0.013|TWO_SIDED|95.0|3.9|28.2|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||28.2|3.9|0.013
74073603|NCT01706926|147699611|SUPERIORITY_OR_OTHER||Percent difference|13.5||||0.03|TWO_SIDED|95.0|1.8|25.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||25.3|1.8|0.030
74073604|NCT01706926|147699611|SUPERIORITY_OR_OTHER||Percent difference|28.2|||<|0.001|TWO_SIDED|95.0|15.2|41.1|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||41.1|15.2|<0.001
74073605|NCT01706926|147699612|SUPERIORITY_OR_OTHER||Percent difference|8.6||||0.079|TWO_SIDED|95.0|0.4|16.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||16.9|0.4|0.079
74073606|NCT01706926|147699612|SUPERIORITY_OR_OTHER||Percent difference|6.9||||0.133|TWO_SIDED|95.0|-0.8|14.6|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||14.6|-0.8|0.133
74073607|NCT01706926|147699612|SUPERIORITY_OR_OTHER||Percent difference|10.2||||0.026|TWO_SIDED|95.0|1.5|18.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||18.9|1.5|0.026
74073608|NCT01706926|147699613|SUPERIORITY_OR_OTHER||Adjusted Mean difference|15.79|STANDARD_ERROR_OF_MEAN|6.007||0.009|TWO_SIDED|95.0|3.96|27.61|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||27.61|3.96|0.009
73884141|NCT02977403|147302121|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass and height, race and ethnicity.|beta coefficent|-0.002|||||TWO_SIDED|95.0|-0.085|0.082||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post-intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.082|-0.085|
73884142|NCT02977403|147302121|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.053|||||TWO_SIDED|95.0|-0.177|0.071||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.071|-0.177|
73884143|NCT02977403|147302122|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.08|||||TWO_SIDED|95.0|-0.022|0.182||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.182|-0.022|
73884144|NCT02977403|147302122|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.018|||||TWO_SIDED|95.0|-0.139|0.103||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.103|-0.139|
73884145|NCT02977403|147302123|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.013|||||TWO_SIDED|95.0|-0.086|0.113||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.113|-0.086|
73884146|NCT02977403|147302123|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.035|||||TWO_SIDED|95.0|-0.179|0.109||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.109|-0.179|
74073609|NCT01706926|147699613|SUPERIORITY_OR_OTHER||Adjusted mean difference|16.99|STANDARD_ERROR_OF_MEAN|5.879||0.004|TWO_SIDED|95.0|5.42|28.56|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||28.56|5.42|0.004
74073610|NCT01706926|147699613|SUPERIORITY_OR_OTHER||Adjusted mean difference|27.47|STANDARD_ERROR_OF_MEAN|5.892|<|0.001|TWO_SIDED|95.0|15.87|39.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||39.07|15.87|<0.001
74073611|NCT01706926|147699614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7|||<|0.001|TWO_SIDED|95.0|2.56|8.8|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios greater than (\>) one favored mavrilimumab.|||8.80|2.56|<0.001
73888514|NCT05465317|147309652|OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.71|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.71|0.10
74073612|NCT01706926|147699614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.001|TWO_SIDED|95.0|2.64|8.92|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios \>one favored mavrilimumab.|||8.92|2.64|<0.001
74073613|NCT01706926|147699614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.11|||<|0.001|TWO_SIDED|95.0|3.85|13.4|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios \>one favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||13.40|3.85|<0.001
74073614|NCT01706926|147699615|SUPERIORITY_OR_OTHER||Percent difference|16.0||||0.004|TWO_SIDED|95.0|6.0|26.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||26.1|6.0|0.004
74073615|NCT01706926|147699615|SUPERIORITY_OR_OTHER||Percent difference|12.7||||0.014|TWO_SIDED|95.0|3.3|22.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||22.1|3.3|0.014
74073616|NCT01706926|147699615|SUPERIORITY_OR_OTHER||Percent difference|14.0||||0.007|TWO_SIDED|95.0|4.2|23.9|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||23.9|4.2|0.007
74073617|NCT01706926|147699615|SUPERIORITY_OR_OTHER||Percent difference|24.7|||<|0.001|TWO_SIDED|95.0|12.7|36.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||36.6|12.7|<0.001
74073618|NCT01706926|147699615|SUPERIORITY_OR_OTHER||Percent difference|23.1|||<|0.001|TWO_SIDED|95.0|11.5|34.8|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||34.8|11.5|<0.001
74073619|NCT01706926|147699615|SUPERIORITY_OR_OTHER||Percent difference|33.1|||<|0.001|TWO_SIDED|95.0|20.7|45.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||45.6|20.7|<0.001
74073620|NCT01706926|147699616|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.68|STANDARD_ERROR_OF_MEAN|1.237|<|0.001|TWO_SIDED|95.0|-8.12|-3.24|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-3.24|-8.12|<0.001
74073621|NCT01706926|147699616|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.21|STANDARD_ERROR_OF_MEAN|1.211|<|0.001|TWO_SIDED|95.0|-8.6|-3.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-3.82|-8.60|<0.001
74073622|NCT01706926|147699616|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.219|<|0.001|TWO_SIDED|95.0|-9.4|-4.59|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-4.59|-9.40|<0.001
74073623|NCT01706926|147699616|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.24|STANDARD_ERROR_OF_MEAN|1.922|<|0.001|TWO_SIDED|95.0|-11.02|-3.45|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-3.45|-11.02|<0.001
74073624|NCT01706926|147699616|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.45|STANDARD_ERROR_OF_MEAN|1.884|<|0.001|TWO_SIDED|95.0|-12.16|-4.74|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-4.74|-12.16|<0.001
74073625|NCT01706926|147699616|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.42|STANDARD_ERROR_OF_MEAN|1.901|<|0.001|TWO_SIDED|95.0|-14.17|-6.67|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-6.67|-14.17|<0.001
74073626|NCT01706926|147699617|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.94|STANDARD_ERROR_OF_MEAN|3.95||0.045|TWO_SIDED|95.0|-15.72|-0.17|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.17|-15.72|0.045
74073627|NCT01706926|147699617|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.11|STANDARD_ERROR_OF_MEAN|3.876||0.037|TWO_SIDED|95.0|-15.73|-0.48|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.48|-15.73|0.037
73884147|NCT02977403|147302124|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.083|||||TWO_SIDED|95.0|-0.001|0.167||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.167|-0.001|
73884148|NCT02977403|147302124|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.069|||||TWO_SIDED|95.0|-0.201|0.063||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.063|-0.201|
73888360|NCT03594110|147309573|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0017 required at interim analysis."|Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|99.83|0.59|0.89|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression or CV death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||0.89|0.59|<0.0001
74073628|NCT01706926|147699617|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.32|STANDARD_ERROR_OF_MEAN|3.899||0.004|TWO_SIDED|95.0|-19.0|-3.65|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-3.65|-19.00|0.004
74073629|NCT01706926|147699618|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.85|STANDARD_ERROR_OF_MEAN|4.137||0.837|TWO_SIDED|95.0|-8.99|7.29|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||7.29|-8.99|0.837
74073630|NCT01706926|147699618|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|4.058||0.589|TWO_SIDED|95.0|-10.18|5.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||5.79|-10.18|0.589
74073631|NCT01706926|147699618|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.48|STANDARD_ERROR_OF_MEAN|4.083||0.18|TWO_SIDED|95.0|-13.52|2.55|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||2.55|-13.52|0.180
74073632|NCT01706926|147699619|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-2.2|-0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.63|-2.20|<0.001
74073633|NCT01706926|147699619|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.46|STANDARD_ERROR_OF_MEAN|0.389|<|0.001|TWO_SIDED|95.0|-2.23|-0.69|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.69|-2.23|<0.001
74073634|NCT01706926|147699619|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.391|<|0.001|TWO_SIDED|95.0|-2.33|-0.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.79|-2.33|<0.001
74073635|NCT01706926|147699620|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.479|TWO_SIDED|95.0|-0.29|0.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||0.14|-0.29|0.479
74073636|NCT01706926|147699620|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.106||0.124|TWO_SIDED|95.0|-0.37|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||0.04|-0.37|0.124
74073637|NCT01706926|147699620|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.107||0.017|TWO_SIDED|95.0|-0.47|-0.05|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.05|-0.47|0.017
74073638|NCT01706926|147699621|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.64||||0.017|TWO_SIDED|95.0|0.45|0.92|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.92|0.45|0.017
74073639|NCT01706926|147699621|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.32|0.66|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.66|0.32|<0.001
74073640|NCT01706926|147699621|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.44|||<|0.001|TWO_SIDED|95.0|0.31|0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.63|0.31|<0.001
74073641|NCT01706926|147699622|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.72||||0.003|TWO_SIDED|95.0|0.58|0.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.89|0.58|0.003
74073642|NCT01706926|147699622|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.55|0.84|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.84|0.55|<0.001
74073643|NCT01706926|147699622|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.49|0.75|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.75|0.49|<0.001
74073644|NCT01706926|147699623|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.21|TWO_SIDED|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||10.7|-0.8|0.210
74073645|NCT01706926|147699623|SUPERIORITY_OR_OTHER||Percent difference|1.1||||1|TWO_SIDED|95.0|-2.9|5.1|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||5.1|-2.9|1.000
74073646|NCT01706926|147699623|SUPERIORITY_OR_OTHER||Percent difference|3.8||||0.207|TWO_SIDED|95.0|-1.6|9.2|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||9.2|-1.6|0.207
74073647|NCT01706926|147699624|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.21|TWO_SIDED|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||10.7|-0.8|0.210
74073648|NCT01706926|147699624|SUPERIORITY_OR_OTHER||Percent difference|2.3||||0.621|TWO_SIDED|95.0|-2.3|6.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||6.9|-2.3|0.621
74073649|NCT01706926|147699624|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.062|TWO_SIDED|95.0|0.0|12.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||12.7|0.0|0.062
74073650|NCT01706926|147699625|SUPERIORITY_OR_OTHER||Percent difference|3.7||||0.245|TWO_SIDED|95.0|-0.4|7.8|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||7.8|-0.4|0.245
74073651|NCT01706926|147699625|SUPERIORITY_OR_OTHER||Percent difference|1.2||||1|TWO_SIDED|95.0|-1.1|3.5|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||3.5|-1.1|1.000
74073652|NCT01706926|147699625|SUPERIORITY_OR_OTHER||Percent difference|1.3||||0.494|TWO_SIDED|95.0|-1.2|3.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||3.7|-1.2|0.494
74073653|NCT01706926|147699626|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.18|STANDARD_ERROR_OF_MEAN|1.608||0.463|TWO_SIDED|95.0|-1.99|4.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||4.35|-1.99|0.463
74073654|NCT01706926|147699626|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.27|STANDARD_ERROR_OF_MEAN|1.574||0.151|TWO_SIDED|95.0|-0.83|5.37|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||5.37|-0.83|0.151
74073655|NCT01706926|147699626|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.92|STANDARD_ERROR_OF_MEAN|1.578||0.014|TWO_SIDED|95.0|0.81|7.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||7.02|0.81|0.014
74073656|NCT01475838|147699644|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the Stribild group was at least 12% worse than the PI+RTV+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA \< 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the PI+RTV+FTC/TDF group.|Difference in proportions|6.7||||0.025|TWO_SIDED|95.0|0.4|13.7|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.|||13.7|0.4|0.025
74073657|NCT00048568|147699653|SUPERIORITY_OR_OTHER||Estimated Difference|28.2|||<|0.001|TWO_SIDED|95.0|19.8|36.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response.|The study had a 99% power to detect a difference of 20% in ACR 20 between the 2 groups at the 5% level.||36.7|19.8|<0.001
74073658|NCT00048568|147699654|SUPERIORITY_OR_OTHER||Estimated Difference|24.4|||<|0.001|TWO_SIDED|95.0|15.9|32.9||Based on the hierarchical testing procedure for the co-primary measures, the study had 98% power to detect 18% difference in HAQ response rate between the two arms at the 5% level.|Chi-squared, Corrected|This model includes treatment as the main factor and baseline value as a covariate.|Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving HAQ response at Day 365.|||32.9|15.9|<0.001
74073659|NCT00048568|147699655|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Nonparametric ANCOVA|The rank of the change from baseline=dependent variable, treatment=the main factor, rank of baseline value as covariate.||||||0.029
74073660|NCT00048568|147699659|SUPERIORITY_OR_OTHER||Estimated Difference|33.4|||<|0.001|TWO_SIDED|95.0|25.1|41.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response at Day 365.|||41.7|25.1|<0.001
74073661|NCT00048568|147699661|SUPERIORITY_OR_OTHER||Estimated Difference|23.0|||<|0.001|TWO_SIDED|95.0|15.0|31.1|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 169.|||31.1|15.0|<0.001
74073662|NCT00048568|147699662|SUPERIORITY_OR_OTHER||Estimated Difference|30.1|||<|0.001|TWO_SIDED|95.0|21.8|38.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 365.|||38.5|21.8|<0.001
74073663|NCT00048568|147699664|SUPERIORITY_OR_OTHER||Estimated Difference|13.3|||<|0.001|TWO_SIDED|95.0|7.0|19.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA + MTX and MTX + PLA in the proportion of participants achieving ACR 70 response at Day 169.|||19.5|7.0|<0.001
74073664|NCT00048568|147699665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|||<|0.001|TWO_SIDED|95.0|15.6|29.8|||Chi-squared, Corrected|||||29.8|15.6|<0.001
74073665|NCT00048568|147699667|SUPERIORITY_OR_OTHER||Estimated Difference|12.3|||<|0.001|TWO_SIDED|95.0|7.3|17.2|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving MCR.|||17.2|7.3|<0.001
74073666|NCT00048568|147699668|SUPERIORITY_OR_OTHER||Estimated Difference on Day 169|-1.15|||<|0.001|TWO_SIDED|95.0|-1.38|-0.91|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 169.|||-0.91|-1.38|<0.001
74073667|NCT00048568|147699668|SUPERIORITY_OR_OTHER||Estimated Difference on Day 365|-1.39|||<|0.001|TWO_SIDED|95.0|-1.63|-1.16|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 365.|||-1.16|-1.63|<0.001
74073668|NCT00048568|147699672|SUPERIORITY_OR_OTHER||Adjusted Mean Difference at Day 169|4.06|||<|0.001|TWO_SIDED|95.0|2.64|5.57|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||5.57|2.64|<0.001
73884149|NCT02977403|147302125|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity|beta coefficient|0.031|||||TWO_SIDED|95.0|-0.059|0.121||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.121|-0.059|
74073669|NCT00048568|147699672|SUPERIORITY_OR_OTHER||Adjusted Mean Difference at Day 365|4.15|||<|0.001|TWO_SIDED|95.0|2.69|5.62|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||5.62|2.69|<0.001
74073670|NCT00048568|147699673|SUPERIORITY_OR_OTHER||Estimated Difference|5.7||||0.002|TWO_SIDED|95.0|2.4|9.0|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving extended MCR.|||9.0|2.4|0.002
74073671|NCT03831048|147699799|NON_INFERIORITY|The primary analysis of this endpoint will be performed using a linear probability model, with the following terms in the model: (1) treatment; and (2) the known donor and recipient risk factors listed above. Variables that make the model fail to converge will be dropped from the model. The test will be conducted at the one-sided 0.05 level of significance.|Mean Difference (Final Values)|-0.032|||<|0.0001|TWO_SIDED|90.0|-0.098|0.034||No multiple comparison adjustment.|Regression, Linear|||"The null and alternative hypotheses for the primary endpoint are as follows:~H0: pSOC - pDCD ≥ 0.20 vs. H1: pSOC - pDCD \< 0.20 where pDCD and pSOC represent the true survival proportions at the six months follow-up visit for DCD and SOC heart transplant patients, respectively."||0.034|-0.098|<0.0001
74073672|NCT03831048|147699800|OTHER|No hypothesis test.||||||||||||||||No null hypothesis test.|No statistical hypothesis testing. This endpoint will be summarized for the OCS Heart Population using counts and percentages and an exact (Clopper-Pearson) 95% confidence interval for the true percentage based on the binomial distribution. It will also be summarized for the modified OCS Heart Population, defined as the number of DCD hearts that were successfully transplanted after preservation and assessment on the OCS divided by the total number of DCD donor hearts that were instrumented on the OCS.|||
74073673|NCT01027780|147699818|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Please note that this analysis tested the differences between groups following the intervention.|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.||||||.007
74073674|NCT01027780|147699819|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Note that this is the p value for differences between groups immediately following the intervention|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.||||||.04
74073675|NCT01027780|147699820|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Difference between groups following intervention|ANOVA|||||||.03
74073676|NCT00771537|147699837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED|95.0|0.5|0.96|||Regression, Logistic||Women in the 1-sided message group accepted testing at a lower rate (79.4%) than those in the control group (87.4%).|||.96|.50|0.05
74073677|NCT00771537|147699837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|STANDARD_ERROR_OF_MEAN|0.17||0.1|TWO_SIDED|95.0|0.54|1.04|||Regression, Logistic||Women in the 2-sided trivial group were no different in their acceptance rate of HIV testing (81.3%) than women in the control group (87.4%).|||1.04|.54|.10
73884150|NCT02977403|147302125|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.002|||||TWO_SIDED|95.0|-0.157|0.152||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.152|-0.157|
74073678|NCT00771537|147699837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.176||0.63|TWO_SIDED|95.0|0.65|1.3|||Regression, Logistic||Women in the 2-sided major group were no different in rates of accepting HIV testing (83.9%) than women in the control group (87.4%)|||1.30|.65|.63
74073679|NCT00771537|147699838|SUPERIORITY_OR_OTHER||Marginal Means|2.49|STANDARD_ERROR_OF_MEAN|0.037|<|0.6|TWO_SIDED|95.0|2.42|2.56|||ANOVA|Degrees of freedom = (1,978)|There was no significant effect for the 1-sided message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-way Analysis of Variance||2.56|2.42|<.60
74073680|NCT00771537|147699838|SUPERIORITY_OR_OTHER||Marginal Means|2.51|STANDARD_ERROR_OF_MEAN|0.036|<|0.25|TWO_SIDED|95.0|2.44|2.58|||ANOVA|degrees of freedom = (1,1028)|There was no significant effect for the 2-sided trivial message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance||2.58|2.44|<.25
74073681|NCT00771537|147699838|SUPERIORITY_OR_OTHER||Marginal Means|2.47|STANDARD_ERROR_OF_MEAN|0.036|<|0.91|TWO_SIDED|95.0|2.4|2.54|||ANOVA||There was no significant effect for the 2-sided major message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance||2.54|2.40|<.91
74073682|NCT04099888|147699840|SUPERIORITY||||||||TWO_SIDED|95.0|||||||||The HR was estimated using an unstratified cox-proportional hazards model using the Efron approach for handling ties (Efron 1977), together with the associated 95% confidence intervals (CI) for the HR based on the Wald method. The effect of treatment is summarized by the hazard ratio (HR) together with its corresponding 95% Wald CI for the mITT population. No p-value will be reported.|||
73884151|NCT02977403|147302126|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.042|||||TWO_SIDED|95.0|-0.149|0.065||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.065|-0.149|
73884152|NCT02977403|147302126|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.068|||||TWO_SIDED|95.0|-0.266|0.131||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.131|-0.266|
73884153|NCT02977403|147302127|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.034|||||TWO_SIDED|95.0|-0.122|0.053||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.053|-0.122|
73884154|NCT02977403|147302127|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.07|||||TWO_SIDED|95.0|-0.233|0.092||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.092|-0.233|
73884155|NCT02977403|147302128|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.042|||||TWO_SIDED|95.0|-0.041|0.126||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.126|-0.041|
73884156|NCT02977403|147302128|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.252|0.082||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.082|-0.252|
73884157|NCT02977403|147302129|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.021|||||TWO_SIDED|95.0|-0.06|0.102||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.102|-0.060|
73884158|NCT02977403|147302129|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.071|||||TWO_SIDED|95.0|-0.26|0.119||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.119|-0.260|
74073683|NCT04099888|147699841|SUPERIORITY||||||||TWO_SIDED|95.0||||||||OS was analyzed using the modified intent-to-treat (mITT) analysis set, which included all randomized participants who received at least 1 dose of study treatment and had a RECIST assessment at baseline. Kaplan Meier Curve (KM) analysis of OS was completed for the mITT population, but the number of events was too small to draw any conclusions.|The HR was estimated using an unstratified cox-proportional hazards model using the Efron approach for handling ties (Efron 1977), together with the associated 95% confidence intervals (CI) for the HR based on the Wald method. The effect of treatment is summarized by the hazard ratio (HR) together with its corresponding 95% Wald CI for the mITT population. No p-value will be reported.|||
74073684|NCT04099888|147699842|SUPERIORITY|||||||||||||||||BOR is summarized by randomized treatment group using the mITT analysis set.|The BOR is the best response recorded from the start of the treatment until disease progression or until the last evaluable assessment in the absence of progression. If a patient received subsequent anti-cancer therapy prior to progression, then BOR was calculated up to the point of starting the anti-cancer therapy.|||
73884159|NCT02977403|147302130|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.107|||||TWO_SIDED|95.0|0.03|0.185||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.185|0.030|
73884160|NCT02977403|147302130|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.197|||||TWO_SIDED|95.0|-0.346|-0.047||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.047|-0.346|
74073685|NCT04099888|147699843|SUPERIORITY||||||||TWO_SIDED|95.0|||||||||The ORR is calculated as the proportion of patients who have at least one visit response with a complete response (CR) or partial response (PR). Objective responses do not require confirmation in a randomized study. Data obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the analysis of ORR. Data obtained up until progression or subsequent therapy, or last evaluable assessment in the absence of progression or subsequent therapy, will be included in the analysis of ORR.|||
74073686|NCT04099888|147699844|SUPERIORITY|||||||||||||||||The DoR was calculated only for those with a documented response of CR or PR and is defined as the time from the date of first documented tumor response until the first date of documented disease progression or death, whichever is earlier.|DoR is listed only. In Arm A, the duration of response was 169 days in 1 participant before radiological progression was seen. In the other 2 participants in Arm A, the events were censored at 260 and 264 days, respectively. In Arm B, the duration of response was 85 days in 1 participant before radiological progression was seen. In the other 2 participants in Arm B, the events were censored at 1 day due to the early termination of the study.|||
74073687|NCT04099888|147699845|SUPERIORITY||||||||TWO_SIDED|95.0||||||||DCR is reported and includes any patient with a best response of stable disease, PR or CR.|The DCR and associated exact 95% CI is summarized for the mITT population. This was repeated for DCR-6, defined as the proportion of patients with CR, PR or SD at 6 months (recorded at least 24 weeks (+/-1 week) after randomization of study treatment and prior to any PD event).|||
74073688|NCT04099888|147699846|SUPERIORITY|||||||||||||||||Change in tumor size in percentage was summarized for the subset of patients in the mITT analysis set who had measurable disease at baseline.|Tumor size is defined as the sum of the longest diameters (SoDs) of the RECIST 1.1 target lesions. Change in tumor size is defined as the best overall percentage change in tumor size from baseline. Percentage change in tumor size was determined for patients with measurable disease at baseline and was derived at each visit by the percentage change in the SoDs of target lesions compared to baseline.|||
74073689|NCT04099888|147699847|SUPERIORITY||||||||||||||||||Safety, including the incidence and characteristics of biliary/loco-regional tumour-related events leading to hospitalisation and/or interventions, will be summarised descriptively.|||
74073690|NCT04099888|147699848|SUPERIORITY||||||||||||||||||Safety events leading to hospitalisation and/or interventions, will be summarised descriptively.|||
74073691|NCT04099888|147699852|SUPERIORITY||||||||||||||||||As this study was terminated early, a reduced statistical analysis was conducted, and the HRQoL analyses were not conducted.|||
74073692|NCT04538170|147699853|SUPERIORITY|||||||0.013||||||threshold for statistical significance|Fisher Exact|||Preliminary work showed that approximately 25% of patients report phantom pain after orchidectomy. A difference of 20% between the GAC and ORC groups was considered relevant. Power was set to 80% and the significance level to 5%, resulting in a minimum of 40 women to be recruited, which was fulfilled.||||0.013
74073693|NCT00637299|147699856|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 1 sided|||||||<0.01
74073694|NCT00637299|147699857|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
74073695|NCT00864097|147699871|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.039|TWO_SIDED|95.0|-0.81|-0.02|||ANCOVA|||LS means were estimated from the corresponding analysis of covariance (ANCOVA) model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.02|-0.81|0.039
74073696|NCT00864097|147699871|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.91|-0.12|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.12|-0.91|0.011
74073697|NCT00864097|147699871|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.2||0.005|TWO_SIDED|95.0|-0.97|-0.17|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.17|-0.97|0.005
74073698|NCT00864097|147699872|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|-0.91|-0.12|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.12|-0.91|0.010
74073699|NCT00864097|147699872|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.03|-0.23|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.23|-1.03|0.002
74073700|NCT00864097|147699872|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.30|-1.10|<0.001
74073701|NCT00864097|147699873|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.022|TWO_SIDED|95.0|-0.32|-0.03|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.32|0.022
74073702|NCT00864097|147699873|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.33|-0.03|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.33|0.020
74073703|NCT00864097|147699873|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.4|-0.09|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.09|-0.40|0.002
74073704|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.957|TWO_SIDED|95.0|-0.32|0.34|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.34|-0.32|0.957
74073705|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.17||0.899|TWO_SIDED|95.0|-0.31|0.35|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.35|-0.31|0.899
74073706|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.17||0.022|TWO_SIDED|95.0|0.06|0.72|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.72|0.06|0.022
74073707|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.052|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.00|-0.70|0.052
74073708|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.34|-1.05|<0.001
73888515|NCT05465317|147309653|OTHER||Hazard Ratio (HR)|1.37||||0.15|TWO_SIDED|95.0|0.89|2.1|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.10|0.89|0.15
74073709|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.008|TWO_SIDED|95.0|-0.84|-0.13|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.13|-0.84|0.008
74073710|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.058|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.01|-0.72|0.058
74073711|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.05|-0.32|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.32|-1.05|<0.001
74073712|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.12|-0.38|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.38|-1.12|<0.001
74073713|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.91|-0.15|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.15|-0.91|0.007
73884161|NCT02977403|147302131|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.092|||||TWO_SIDED|95.0|0.01|0.175||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.175|0.010|
73884162|NCT02977403|147302131|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.049|||||TWO_SIDED|95.0|-0.204|0.107||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.107|-0.204|
73884163|NCT02977403|147302132|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.046|||||TWO_SIDED|95.0|-0.032|0.123||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.123|-0.032|
73884164|NCT02977403|147302132|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.007|||||TWO_SIDED|95.0|-0.163|0.177||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.177|-0.163|
73888516|NCT05465317|147309653|OTHER||Hazard Ratio (HR)|1.05||||0.93|TWO_SIDED|95.0|0.4|2.72|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.72|0.40|0.93
74073714|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.18|-0.41|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.41|-1.18|<0.001
74073715|NCT00864097|147699874|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.28|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.28|-1.05|<0.001
74073716|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.15||0.754|TWO_SIDED|95.0|-0.25|0.35|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.35|-0.25|0.754
74073717|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.706|TWO_SIDED|95.0|-0.36|0.25|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.25|-0.36|0.706
74073718|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.16||0.266|TWO_SIDED|95.0|-0.13|0.48|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.48|-0.13|0.266
74073719|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.195|TWO_SIDED|95.0|-0.58|0.12|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.12|-0.58|0.195
74073720|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.07|-0.36|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.36|-1.07|<0.001
74073721|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.019|TWO_SIDED|95.0|-0.78|-0.07|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.07|-0.78|0.019
74073722|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.126|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.08|-0.64|0.126
74073723|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.1|-0.37|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.37|-1.10|<0.001
74073724|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-0.98|-0.25|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.25|-0.98|0.001
74073725|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.9|-0.15|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.15|-0.90|0.007
74073726|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.21|-0.44|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.44|-1.21|<0.001
74073727|NCT00864097|147699875|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.02|-0.25|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.25|-1.02|0.001
74073728|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.2|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.05|-0.22|0.200
74073729|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.754|TWO_SIDED|95.0|-0.15|0.11|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.11|-0.15|0.754
74073730|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.07||0.449|TWO_SIDED|95.0|-0.08|0.18|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.18|-0.08|0.449
74073731|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.062|TWO_SIDED|95.0|-0.27|0.01|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.01|-0.27|0.062
74073732|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.36|-0.08|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.08|-0.36|0.002
74073733|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.026|TWO_SIDED|95.0|-0.3|-0.02|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.02|-0.30|0.026
74073734|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.032|TWO_SIDED|95.0|-0.31|-0.01|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.01|-0.31|0.032
74073735|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.48|-0.19|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.19|-0.48|<0.001
74073736|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.45|-0.16|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.16|-0.45|<0.001
74073737|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.038|TWO_SIDED|95.0|-0.3|-0.01|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.01|-0.30|0.038
74073738|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.37|-0.07|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.07|-0.37|0.003
74073739|NCT00864097|147699876|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.016|TWO_SIDED|95.0|-0.33|-0.03|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.33|0.016
74073740|NCT00849901|147699903|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Mixed Models Analysis|||||||0.999
74073741|NCT00262223|147699915|SUPERIORITY_OR_OTHER_LEGACY||Incidence Rate Ratio|1.6||||0.34|TWO_SIDED|95.0|0.61|4.23|||Generalized Estimating Equations|Negative binomial models with log link were applied to the alcohol consumption measure.||Between group analyses were conducted of time-by-treatment interaction that included the four study time points (baseline, end-of-treatment, 6-mos and 12-mos).||4.23|0.61|0.34
74073742|NCT00262223|147699916|SUPERIORITY_OR_OTHER_LEGACY||Parameter Estimate|-16.15||||0.04|TWO_SIDED|95.0|-31.18|-1.13||A trend-level time-by-treatment interaction (p = .096) was probed for simple effects, which revealed a significantly greater reduction in CAPS scores at end-of-treatment in the SS+Sertraline group relative to the SS+Placebo group.|Generalized Estimating Equations|||Generalized estimating equations (GEE) were utilized to model PTSD outcomes. This method is an extension of the generalized linear model that handles correlated data arising from repeated measurements, requires no parametric distribution assumption, and provides robust inference with respect to misspecification of the within-subject correlation. A temporal within-subjects autoregressive \[AR(1)\] correlation matrix was used to model participants across timepoints.||-1.13|-31.18|0.04
74073743|NCT03828734|147699917|SUPERIORITY|||||||0.263|||||||ANOVA|||||||0.263
74073744|NCT03828734|147699918|SUPERIORITY||||||<|1e-06|||||||ANOVA|||||||<0.000001
73884165|NCT02977403|147302133|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.041|||||TWO_SIDED|95.0|-0.03|0.112||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.112|-0.03|
73884166|NCT02977403|147302133|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.014|||||TWO_SIDED|95.0|-0.168|0.14||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.140|-0.168|
74073745|NCT03828734|147699919|SUPERIORITY|||||||0.399|||||||ANOVA|||||||0.399
74073746|NCT01328093|147699931|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-3.2|STANDARD_ERROR_OF_MEAN|0.7|<|0.001||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||<0.001
74073747|NCT01328093|147699932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||P-value is for ≥7% increase.|Cochran-Mantel-Haenszel|||||||0.110
74073748|NCT01328093|147699932|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value is for ≥7% decrease.|Cochran-Mantel-Haenszel|||||||<0.001
74073749|NCT01328093|147699933|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.353||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.353
74073750|NCT01328093|147699934|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.698||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.698
73884167|NCT02977403|147302134|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.037|||||TWO_SIDED|95.0|-0.125|0.052||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.052|-0.125|
73884168|NCT02977403|147302134|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.034|||||TWO_SIDED|95.0|-0.196|0.129||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.129|-0.196|
74073751|NCT01328093|147699935|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.924||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.924
74073752|NCT01328093|147699936|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|3.55|STANDARD_ERROR_OF_MEAN|1.77||0.045||95.0||||P-value is for PANSS Total Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.045
74073753|NCT01328093|147699936|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.21|STANDARD_ERROR_OF_MEAN|0.56||0.032||95.0||||P-value is for PANSS Positive Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.032
74073754|NCT01328093|147699936|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.36|STANDARD_ERROR_OF_MEAN|0.54||0.509||95.0||||P-value is for PANSS Negative Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.509
73888517|NCT05465317|147309653|OTHER||Hazard Ratio (HR)|1.47||||0.113|TWO_SIDED|95.0|0.91|2.38|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.38|0.91|0.113
74073755|NCT01328093|147699936|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|2.05|STANDARD_ERROR_OF_MEAN|1.0||0.04||95.0||||P-value is for PANSS General Psychopathology Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.040
74073756|NCT01328093|147699937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.1|STANDARD_ERROR_OF_MEAN|2.1||0.601||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.601
74073757|NCT01328093|147699938|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.322||95.0||||P-value is for ER/Facility (Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.322
74073758|NCT01328093|147699938|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.099||95.0||||P-value is for ER/Facility (Non-Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.099
73884169|NCT02977403|147302135|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.001|||||TWO_SIDED|95.0|-0.091|0.093||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.093|-0.091|
73884170|NCT02977403|147302135|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.143|||||TWO_SIDED|95.0|-0.286|0.001||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.001|-0.286|
73884171|NCT02977403|147302136|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.065|||||TWO_SIDED|95.0|-0.001|0.132||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.132|-0.001|
73884172|NCT02977403|147302136|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.246|0.055||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.055|-0.246|
73884173|NCT02977403|147302137|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.023|||||TWO_SIDED|95.0|-0.055|0.101||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.101|-0.055|
73884174|NCT02977403|147302137|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.02|||||TWO_SIDED|95.0|-0.178|0.137||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.137|-0.178|
74073759|NCT01328093|147699938|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.787||95.0||||P-value is for Outpatient (Non-Psych or Dentist) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.787
74073760|NCT01328093|147699939|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.892||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.892
74073761|NCT01328093|147699940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.63||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.630
74073762|NCT01328093|147699941|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5|STANDARD_ERROR_OF_MEAN|1.2||0.679||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.679
74073763|NCT01328093|147699942|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.055||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.055
74073764|NCT01328093|147699943|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|1.11||0.891||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.891
74073765|NCT01328093|147699945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||P-value is for Treatment-Emergent Suicidal Ideation.|Fisher Exact|||||||0.064
74073766|NCT01328093|147699945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||P-value is for Treatment-Emergent Suicidal Behavior.|Fisher Exact|||||||0.205
74073767|NCT00832377|147699947|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 peak IOP vs. baseline|paired t-test|||||||<0.0001
74073768|NCT00832377|147699948|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 trough IOP vs. baseline|paired t-test|||||||<0.0001
74073769|NCT00832377|147699949|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 8-HR IOP vs. baseline|paired t-test|||||||<0.0001
74073770|NCT03661528|147699951|OTHER||Percentage proportion difference|13.4||||0.0032|TWO_SIDED|95.0|4.6|22.2|||Cochran-Mantel-Haenszel|||||22.2|4.6|0.0032
74073771|NCT03661528|147699952|OTHER||Difference in least squares mean|-185.99|||<|0.0001|TWO_SIDED|95.0|-199.93|-172.05|||ANCOVA|Analysis presented for ANCOVA based on ranks.||||-172.05|-199.93|<0.0001
74073772|NCT00615069|147700010|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0|||||Log Rank|||Log-rank test of freedom from major adverse events through 1 year, 31 mm GORE EXCLUDER® Test Subjects vs historical open surgical control Subjects.||||0.003
74073773|NCT00615069|147700011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|||||TWO_SIDED|95.0|0.428|3.603||||||Estimation of Hazard ratio of the 31 mm GORE EXCLUDER® Test Subjects vs original GORE EXCLUDER® AAA Endoprosthesis Subjects (original PMA subjects) using Cox Regression, not a powered analysis.||3.603|0.428|
74073774|NCT00259012|147700019|SUPERIORITY_OR_OTHER|||||||0.087|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.087
74073775|NCT00259012|147700019|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.019
74073776|NCT00259012|147700020|SUPERIORITY_OR_OTHER|||||||0.255|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.255
74073777|NCT00259012|147700020|SUPERIORITY_OR_OTHER|||||||0.031|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline.||||0.031
74073778|NCT00259012|147700021|SUPERIORITY_OR_OTHER|||||||0.099|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.099
74073779|NCT00259012|147700021|SUPERIORITY_OR_OTHER|||||||0.016|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.016
74073780|NCT00259012|147700022|SUPERIORITY_OR_OTHER|||||||0.347|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.347
74073781|NCT00259012|147700022|SUPERIORITY_OR_OTHER|||||||0.012|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.012
74073782|NCT00259012|147700023|SUPERIORITY_OR_OTHER|||||||0.339|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.339
73884175|NCT02977403|147302138|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.032|||||TWO_SIDED|95.0|-0.116|0.051||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.051|-0.116|
73884176|NCT02977403|147302138|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.06|||||TWO_SIDED|95.0|-0.104|0.223||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.223|-0.104|
73884177|NCT02977403|147302139|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.012|||||TWO_SIDED|95.0|-0.078|0.053||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.053|-0.078|
73884178|NCT02977403|147302139|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.064|||||TWO_SIDED|95.0|-0.248|0.12||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.120|-0.248|
73884179|NCT02977403|147302140|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.089|||||TWO_SIDED|95.0|0.004|0.174||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.174|0.004|
73884180|NCT02977403|147302140|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.021|||||TWO_SIDED|95.0|-0.159|0.201||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.201|-0.159|
73888361|NCT03594110|147309574|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0145 required at interim analysis."|Hazard Ratio (HR)|0.84||||0.1363|TWO_SIDED|98.55|0.63|1.12|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first hospitalization for heart failure or cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||1.12|0.63|0.1363
74073783|NCT00259012|147700023|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.003
74073784|NCT00259012|147700024|SUPERIORITY_OR_OTHER|||||||0.982|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.982
74073785|NCT00259012|147700024|SUPERIORITY_OR_OTHER|||||||0.534|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.534
74073786|NCT00259012|147700025|SUPERIORITY_OR_OTHER|||||||0.166|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.166
74073787|NCT00259012|147700025|SUPERIORITY_OR_OTHER|||||||0.119|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.119
74073788|NCT00259012|147700026|SUPERIORITY_OR_OTHER|||||||0.387|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.387
74073789|NCT00259012|147700026|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.021
74073790|NCT01941030|147700042|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.022|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty reduction of calcium out of lumen gain.||||0.0220
74073791|NCT01941030|147700043|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6228|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-balloon angioplasty minimum lumen area stenosis.||||0.6228
74073792|NCT01941030|147700044|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.4528|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty plaque area.||||0.4528
73884181|NCT02977403|147302141|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.113|0.081||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.081|-0.113|
73884182|NCT02977403|147302141|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.072|||||TWO_SIDED|95.0|-0.206|0.062||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.062|-0.206|
73884183|NCT02977403|147302142|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.129|||||TWO_SIDED|95.0|0.049|0.209||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.209|0.049|
73884184|NCT02977403|147302142|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.181|||||TWO_SIDED|95.0|-0.33|-0.033||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.033|-0.330|
73884185|NCT02977403|147302143|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.126|||||TWO_SIDED|95.0|0.045|0.207||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.207|0.045|
73884186|NCT02977403|147302143|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.056|||||TWO_SIDED|95.0|-0.223|0.112||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.112|-0.223|
73884187|NCT02977403|147302144|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.115|||||TWO_SIDED|95.0|0.027|0.203||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.203|0.027|
74073793|NCT01941030|147700045|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.3573|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty dense calcium area.||||0.3573
73884188|NCT02977403|147302144|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.058|||||TWO_SIDED|95.0|-0.203|0.087||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.087|-0.203|
74073794|NCT01941030|147700046|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6073|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty necrotic core area.||||0.6073
74073795|NCT01941030|147700047|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.2149|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrous plaque area.||||0.2149
73884189|NCT02977403|147302145|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.037|||||TWO_SIDED|95.0|-0.053|0.127||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.127|-0.053|
73884190|NCT02977403|147302145|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.24|0.069||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.069|-0.240|
73884191|NCT02977403|147302146|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.021|||||TWO_SIDED|95.0|-0.092|0.05||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.050|-0.092|
73884192|NCT02977403|147302146|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.249|0.056||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.056|-0.249|
73884193|NCT02977403|147302147|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.013|||||TWO_SIDED|95.0|-0.095|0.069||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.069|-0.095|
73884194|NCT02977403|147302147|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.078|||||TWO_SIDED|95.0|-0.227|0.071||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.071|-0.227|
74073796|NCT01941030|147700048|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.0579|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrofatty plaque area.||||0.0579
74073797|NCT01941030|147700049|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.076|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 600 mcg adenosine.||||0.076
73884195|NCT02977403|147302148|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.005|||||TWO_SIDED|95.0|-0.103|0.092||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.092|-0.103|
74073798|NCT01941030|147700049|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.205|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 1200 mcg adenosine.||||0.205
74073799|NCT02781727|147700073|NON_INFERIORITY|Non-inferiority comparison with a non-inferiority margin of 2 cm/year, followed by a test of superiority if non-inferiority is established.||||||0.0088||||||P-value is based on a test of superiority|ANCOVA with multiple imputation|two-sided||ANCOVA model with multiple imputation. For each imputed data set, an ANCOVA model with by visit AHV as the dependent variable; treatment and gender as factors; and baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline height SDS - average parental height SDS as covariates were fitted.||||0.0088
73884196|NCT02977403|147302148|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.032|||||TWO_SIDED|95.0|-0.173|0.11||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.110|-0.173|
73884197|NCT02977403|147302149|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.02|||||TWO_SIDED|95.0|-0.069|0.109||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.109|-0.069|
73884198|NCT02977403|147302149|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.088|||||TWO_SIDED|95.0|-0.252|0.077||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.077|-0.252|
74073800|NCT01918800|147700080|SUPERIORITY_OR_OTHER|||||||0.64||||||No adjustment for multiple comparisons. A priori threshold for clinical significance was 7 point improvement.|paired t test|||||||.64
74073801|NCT01918800|147700081|SUPERIORITY_OR_OTHER|||||||0.04||||||No adjustments for multiple comparisons.|paired t test|||||||0.04
74073802|NCT01918800|147700082|SUPERIORITY_OR_OTHER|||||||0.35||||||No adjustment for multiple comparisons|Paired t test|||||||0.35
74073803|NCT01918800|147700083|SUPERIORITY|||||||0.8||||||The p value in this case is for the SF-36 Physical|Wilcoxon (Mann-Whitney)|||||||0.8
74073804|NCT01918800|147700083|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||The p value in this case refers to the SF-36 Mental||||.09
74073805|NCT01918800|147700084|SUPERIORITY_OR_OTHER|||||||0.521||||||This p value applies to the RAPA Cardiovascular|Wilcoxon (Mann-Whitney)|||||||0.521
74073806|NCT01918800|147700084|SUPERIORITY|||||||0.4199|||||||Wilcoxon (Mann-Whitney)|||This p values is for the RAPA Strength||||0.4199
74073807|NCT01918800|147700084|SUPERIORITY|||||||0.854|||||||Wilcoxon (Mann-Whitney)|||||||0.854
74073808|NCT01918800|147700085|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
74073809|NCT01918800|147700086|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
74073810|NCT01108094|147700127|OTHER|||||||0.04|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker from baseline to 1 month, for Cohort A1 (vismodegib-naive patients, n = 8).~Paired analysis of tumors shows percent change between baseline (prior to treatment) and post-itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."||||0.04
74073811|NCT01108094|147700127|OTHER|||||||0.079|||||||t-test, 1 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - Cohort A, vismodegib-naive (n = 8) vs control patients Unpaired analysis shows percent change between individual tumors from control patients and itraconazole treated patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."||||0.079
74073812|NCT01108094|147700127|OTHER|||||||0.652|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - control patients Paired analysis of tumors shows percent change between baseline and after 1 month in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month."||||0.652
74073813|NCT01108094|147700128|OTHER|||||||0.028|||||||t-test, 2 sided|||"Percentage change in GLI1 messenger RNA (mRNA) expression Paired analysis of tumors shows percent change between baseline (prior to treatment) and post itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Gli levels and the mean Gli level after 1 month of treatment."|Wilcoxon signed rank test|||0.028
74073814|NCT01108094|147700129|OTHER||Mean Difference (Final Values)|24.0|||||TWO_SIDED|95.0|18.2|30.0||||||Only tumors from 4 patients from cohort A (n = 42 BCCs) and all tumors from the 4 patients (n = 14 BCCs) in cohort B were observed for tumor size change. Percent change in tumor area from both cohorts (eight patients total with 57 tumors) was calculated only.||30|18.2|
74073815|NCT01108094|147700129|OTHER|||||||0.435|||||||t-test, 1 sided|||Average tumor size reductions were compared between Cohort A1 and Cohort B.||||0.435
74073816|NCT03290326|147700144|OTHER||||||<|0.01|||||||ANOVA|||One-way ANOVA was conducted to compare the effect of 40Hz tACS on EEG gamma-band spectral power. Power changes were expressed as percentage relative power variations, accordingly with the event-related synchronization/desynchronization (ERS/ERD) index.||||< 0.01
74073817|NCT03422653|147700148|SUPERIORITY||Odds Ratio (OR)|2.72|||<|0.001|TWO_SIDED|95.0|1.72|4.3|||Cui, Hung, Wang|||||4.30|1.72|<0.001
74073818|NCT03422653|147700149|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.0|-0.5|||ANCOVA|||||-0.5|-2.0|<0.001
74073819|NCT03422653|147700150|SUPERIORITY||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|1.44|<|0.001|TWO_SIDED|95.0|-8.0|-2.3|||ANCOVA|||||-2.3|-8.0|<0.001
74073820|NCT03422653|147700151|SUPERIORITY||Odds Ratio (OR)|2.89|||<|0.001|TWO_SIDED|95.0|1.75|4.76|||Cui, Hung, Wang|||||4.76|1.75|<0.001
74073821|NCT01101022|147700152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.2|||<|0.0001|TWO_SIDED|95.0|-15.9|-6.4|||ANCOVA|||||-6.4|-15.9|<0.0001
74073822|NCT01101022|147700153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.6|||<|0.0001|TWO_SIDED|95.0|13.5|29.7|||ANCOVA|||Performance and Daily Functioning||29.7|13.5|<0.0001
74073823|NCT01101022|147700153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.9|||<|0.0001|TWO_SIDED|95.0|7.8|22.0|||ANCOVA|||Daily Interference||22.0|7.8|<0.0001
74073824|NCT01101022|147700153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.5||||0.0003|TWO_SIDED|95.0|6.3|20.7|||ANCOVA|||Bother/Concern||20.7|6.3|0.0003
74073825|NCT01101022|147700153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.0302|TWO_SIDED|95.0|0.8|14.9|||ANCOVA|||Relationships/Communication||14.9|0.8|0.0302
74073826|NCT01101022|147700154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0016|TWO_SIDED|95.0|-7.8|-1.9|||ANCOVA|||Global Executive Composite||-1.9|-7.8|0.0016
74073827|NCT01101022|147700154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.0355|TWO_SIDED|95.0|-6.0|-0.2|||ANCOVA|||Behavioral Regulation Index||-0.2|-6.0|0.0355
74073828|NCT01101022|147700154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7||||0.0003|TWO_SIDED|95.0|-8.7|-2.7|||ANCOVA|||Metacognition Index||-2.7|-8.7|0.0003
74073829|NCT01101022|147700155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.4||||0.0002|TWO_SIDED|95.0|-12.7|-4.0|||ANCOVA|||Behavioral Regulation Index||-4.0|-12.7|0.0002
74073830|NCT01101022|147700155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.3|-7.0|||ANCOVA|||Metacognition Index||-7.0|-16.3|<0.0001
74073831|NCT01101022|147700156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.3||||0.0001|TWO_SIDED|95.0|-12.6|-4.1|||ANCOVA|||Inhibit||-4.1|-12.6|0.0001
74073832|NCT01101022|147700156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7||||0.0018|TWO_SIDED|95.0|-10.8|-2.5|||ANCOVA|||Shift||-2.5|-10.8|0.0018
74073833|NCT01101022|147700156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2||||0.0056|TWO_SIDED|95.0|-8.8|-1.5|||ANCOVA|||Emotional control||-1.5|-8.8|0.0056
74073834|NCT01101022|147700156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2||||0.0001|TWO_SIDED|95.0|-12.3|-4.1|||ANCOVA|||Sef-monitor||-4.1|-12.3|0.0001
74073835|NCT01101022|147700156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-13.2|-5.4|||ANCOVA|||Initiate||-5.4|-13.2|<0.0001
74073836|NCT01101022|147700156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.0|-6.6|||ANCOVA|||Working memory||-6.6|-16.0|<0.0001
74073837|NCT01101022|147700156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|||<|0.0001|TWO_SIDED|95.0|-15.4|-6.4|||ANCOVA|||Plan/Organize||-6.4|-15.4|<0.0001
74073838|NCT01101022|147700156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3||||0.0001|TWO_SIDED|95.0|-14.0|-4.7|||ANCOVA|||Task monitor||-4.7|-14.0|0.0001
74073839|NCT01101022|147700156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9|||<|0.0001|TWO_SIDED|95.0|-12.5|-5.3|||ANCOVA|||Organization of materials||-5.3|-12.5|<0.0001
74073840|NCT01101022|147700157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.0048|TWO_SIDED|95.0|-7.4|-1.4|||ANCOVA|||Inhibit||-1.4|-7.4|0.0048
74073841|NCT01101022|147700157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8||||0.0045|TWO_SIDED|95.0|-8.0|-1.5|||ANCOVA|||Shift||-1.5|-8.0|0.0045
74073842|NCT01101022|147700157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.3605|TWO_SIDED|95.0|-4.0|1.5|||ANCOVA|||Emotional control||1.5|-4.0|0.3605
74073843|NCT01101022|147700157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2||||0.1468|TWO_SIDED|95.0|-5.1|0.8|||ANCOVA|||Self-monitor||0.8|-5.1|0.1468
74073844|NCT01101022|147700157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5||||0.0002|TWO_SIDED|95.0|-8.3|-2.7|||ANCOVA|||Initiate||-2.7|-8.3|0.0002
74073845|NCT01101022|147700157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3||||0.0004|TWO_SIDED|95.0|-9.8|-2.9|||ANCOVA|||Working memory||-2.9|-9.8|0.0004
74073846|NCT01101022|147700157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0015|TWO_SIDED|95.0|-7.9|-1.9|||ANCOVA|||Plan/Organize||-1.9|-7.9|0.0015
74073847|NCT01101022|147700157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3||||0.0003|TWO_SIDED|95.0|-9.7|-2.9|||ANCOVA|||Task monitor||-2.9|-9.7|0.0003
74073848|NCT01101022|147700157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.0234|TWO_SIDED|95.0|-5.9|-0.4|||ANCOVA|||Organization of materials||-0.4|-5.9|0.0234
74073849|NCT01101022|147700158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.1|||<|0.0001|TWO_SIDED|95.0|-14.9|-7.3|||ANCOVA|||||-7.3|-14.9|<0.0001
74073850|NCT01101022|147700161|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
74073851|NCT01101022|147700162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|95.0|5.4|12.7|||ANCOVA|||Living with ADHD||12.7|5.4|<0.0001
74073852|NCT01101022|147700162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.8|||<|0.0001|TWO_SIDED|95.0|6.0|15.5|||ANCOVA|||General Well-being||15.5|6.0|<0.0001
74073853|NCT01101022|147700163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.0184|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Question 1||1.0|0.1|0.0184
74073854|NCT01101022|147700163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0004|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||Question 4||-0.3|-0.9|0.0004
74073855|NCT01101022|147700164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5||||0.0019|TWO_SIDED|95.0|-9.0|-2.1|||ANCOVA|||||-2.1|-9.0|0.0019
74073856|NCT01101022|147700165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.1||||0.0017|TWO_SIDED|95.0|-8.2|-1.9|||ANCOVA|||Inattention/Memory Problems||-1.9|-8.2|0.0017
74073857|NCT01101022|147700165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1||||0.0174|TWO_SIDED|95.0|-7.5|-0.7|||ANCOVA|||Hyperactivity/Restlessness||-0.7|-7.5|0.0174
74073858|NCT01101022|147700165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0||||0.0063|TWO_SIDED|95.0|-6.8|-1.1|||ANCOVA|||Impulsivity/Emotional Liability||-1.1|-6.8|0.0063
74073859|NCT01101022|147700165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.0059|TWO_SIDED|95.0|-7.5|-1.3|||ANCOVA|||Problems with Self-concept||-1.3|-7.5|0.0059
74073860|NCT01101022|147700166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.0||||0.0016|TWO_SIDED|95.0|8.4|33.6|||ANCOVA|||Life Productivity||33.6|8.4|0.0016
73884199|NCT02977403|147302150|OTHER|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.01|||||TWO_SIDED|95.0|-0.099|0.08||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.080|-0.099|
73884200|NCT02977403|147302150|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.155|||||TWO_SIDED|95.0|-0.294|-0.017||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.017|-0.294|
73884201|NCT02977403|147302151|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.013|||||TWO_SIDED|95.0|-0.069|0.095||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.095|-0.069|
74073861|NCT01101022|147700166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1||||0.0242|TWO_SIDED|95.0|1.6|22.5|||ANCOVA|||Psychological Health||22.5|1.6|0.0242
74073862|NCT01101022|147700166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.5||||0.0038|TWO_SIDED|95.0|4.2|20.8|||ANCOVA|||Life Outlook||20.8|4.2|0.0038
74073863|NCT01101022|147700166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3||||0.1752|TWO_SIDED|95.0|-3.4|18.0|||ANCOVA|||Relationships||18.0|-3.4|0.1752
74073864|NCT01101022|147700166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.7||||0.0015|TWO_SIDED|95.0|5.9|23.6|||ANCOVA|||Total Score||23.6|5.9|0.0015
74073865|NCT05628675|147700182|OTHER||Effect size (Hedge's g)|0.32|||||TWO_SIDED|95.0|-0.33|0.96||||||Effect size calculation from Time 1 to Time 2 on MAAS||0.96|-0.33|
73884202|NCT02977403|147302151|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.216|0.047||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.047|-0.216|
74073866|NCT05628675|147700182|OTHER||Effect size (Hedge's g)|0.72|||||TWO_SIDED|95.0|0.02|1.42||||||Effect size calculation from Time 1 to Time 3 on MAAS||1.42|0.02|
74073867|NCT05628675|147700183|OTHER||Effect size (Hedge's g)|0.36|||||TWO_SIDED|95.0|-0.29|1.01||||||Effect size calculation from Time 1 to Time 2 on P-PRFQ||1.01|-0.29|
74073868|NCT05628675|147700183|OTHER||Effect size (Hedge's g)|0.49|||||TWO_SIDED|95.0|-0.2|1.17||||||Effect size calculation from Time 1 to Time 3 on P-PRFQ||1.17|-0.20|
74073869|NCT05628675|147700184|OTHER||Effect size (Hedge's g)|1.48|||||TWO_SIDED|95.0|0.75|2.21||||||Effect size calculation from Time 1 to Time 2 on EPDS||2.21|0.75|
74073870|NCT05628675|147700184|OTHER||Effect size (Hedge's g)|2.08|||||TWO_SIDED|95.0|1.28|2.88||||||Effect size calculation from Time 1 to Time 3 on EPDS||2.88|1.28|
74073871|NCT05818137|147700216|OTHER||Change from baseline estimate|-99.2|||||TWO_SIDED|95.0|-129.6|-68.4|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||-68.4|-129.6|
74073872|NCT05818137|147700219|OTHER||Change from baseline estimate|41.8|||||TWO_SIDED|95.0|27.8|55.5|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||55.5|27.8|
74073873|NCT05818137|147700221|OTHER||Change from baseline estimate|-48.5|||||TWO_SIDED|95.0|-77.0|-24.8|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||-24.8|-77.0|
74073874|NCT02532764|147700235|SUPERIORITY||Difference vs placebo|12.91|STANDARD_ERROR_OF_MEAN|6.53||0.0592|TWO_SIDED|95.0|-0.54|26.35||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||26.35|-0.54|0.0592
74073875|NCT02532764|147700235|SUPERIORITY||difference vs placebo|19.13|STANDARD_ERROR_OF_MEAN|6.56||0.0074|TWO_SIDED|95.0|5.62|32.64||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||32.64|5.62|0.0074
73884203|NCT02977403|147302152|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.041|||||TWO_SIDED|95.0|-0.123|0.041||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.041|-0.123|
73884204|NCT02977403|147302152|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.213|0.021||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.021|-0.213|
73884205|NCT02977403|147302153|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.038|||||TWO_SIDED|95.0|-0.142|0.066||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.066|-0.142|
73884206|NCT02977403|147302153|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.29|0.097||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.097|-0.290|
73884207|NCT02977403|147302154|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.023|||||TWO_SIDED|95.0|-0.105|0.059||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.059|-0.105|
73884208|NCT02977403|147302154|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.124|||||TWO_SIDED|95.0|-0.277|0.029||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.029|-0.277|
73884209|NCT02977403|147302155|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.057|||||TWO_SIDED|95.0|-0.14|0.027||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.027|-0.140|
73884210|NCT02977403|147302155|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.161|||||TWO_SIDED|95.0|-0.302|-0.02||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.020|-0.302|
73888518|NCT05465317|147309654|OTHER||Hazard Ratio (HR)|0.9||||0.43|TWO_SIDED|95.0|0.71|1.16|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.16|0.71|0.43
74073876|NCT02532764|147700235|SUPERIORITY||difference vs placebo|14.24|STANDARD_ERROR_OF_MEAN|6.6||0.0408|TWO_SIDED|95.0|0.64|27.83||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||27.83|0.64|0.0408
74073877|NCT02532764|147700235|SUPERIORITY||difference vs placebo|3.46|STANDARD_ERROR_OF_MEAN|6.87||0.6193|TWO_SIDED|95.0|-10.69|17.6||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||17.60|-10.69|0.6193
74073878|NCT02532764|147700237|SUPERIORITY||Difference vs placebo|23.17|STANDARD_ERROR_OF_MEAN|9.73||0.0321|TWO_SIDED|95.0|2.29|44.04||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||44.04|2.29|0.0321
74073879|NCT02532764|147700237|SUPERIORITY||Difference vs placebo|27.3|STANDARD_ERROR_OF_MEAN|9.17||0.01|TWO_SIDED|95.0|7.64|46.96||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||46.96|7.64|0.0100
74073880|NCT02532764|147700237|SUPERIORITY||Difference vs placebo|20.16|STANDARD_ERROR_OF_MEAN|8.62||0.0346|TWO_SIDED|95.0|1.68|38.64||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||38.64|1.68|0.0346
74073881|NCT02532764|147700237|SUPERIORITY||Difference vs placebo|10.84|STANDARD_ERROR_OF_MEAN|9.01||0.2485|TWO_SIDED|95.0|-8.47|30.16||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||30.16|-8.47|0.2485
74073882|NCT02532764|147700239|SUPERIORITY||difference vs placebo|4.24|STANDARD_ERROR_OF_MEAN|3.18||0.1938|TWO_SIDED|95.0|-2.3|10.79||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariate||10.79|-2.30|0.1938
74073883|NCT02532764|147700239|SUPERIORITY||difference vs placebo|2.75|STANDARD_ERROR_OF_MEAN|3.18||0.3943|TWO_SIDED|95.0|-3.79|9.29||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||9.29|-3.79|0.3943
74073884|NCT02532764|147700239|SUPERIORITY||difference vs placebo|0.53|STANDARD_ERROR_OF_MEAN|3.18||0.8688|TWO_SIDED|95.0|-6.01|7.07||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||7.07|-6.01|0.8688
74073885|NCT02532764|147700239|SUPERIORITY||difference vs placebo|-0.51|STANDARD_ERROR_OF_MEAN|3.35||0.8813|TWO_SIDED|95.0|-7.41|6.39||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||6.39|-7.41|0.8813
74073886|NCT02532764|147700241|SUPERIORITY||Difference vs placebo|10.19|STANDARD_ERROR_OF_MEAN|4.22||0.0301|TWO_SIDED|95.0|1.13|19.25||P-values are presented for Day 33|Mixed Models Analysis|||||19.25|1.13|0.0301
74073887|NCT02532764|147700241|SUPERIORITY||Difference vs placebo|7.99|STANDARD_ERROR_OF_MEAN|3.91||0.0601|TWO_SIDED|95.0|-0.39|16.37||P-values are presented for Day 33|Mixed Models Analysis|||||16.37|-0.39|0.0601
74073888|NCT02532764|147700241|SUPERIORITY||Difference vs placebo|3.5|STANDARD_ERROR_OF_MEAN|3.69||0.358|TWO_SIDED|95.0|-4.4|11.41||P-values are presented for Day 33|Mixed Models Analysis|||||11.41|-4.40|0.3580
74073889|NCT02532764|147700241|SUPERIORITY||Difference vs placebo|3.21|STANDARD_ERROR_OF_MEAN|3.89||0.4224|TWO_SIDED|95.0|-5.13|11.55||P-values are presented for Day 33|Mixed Models Analysis|||||11.55|-5.13|0.4224
74073890|NCT01604850|147700247|SUPERIORITY_OR_OTHER||Proportion difference|-22.4|||<|0.001|TWO_SIDED|95.0|-34.4|-10.3||P-value is from the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization stratification factor (ie, presence/absence of cirrhosis, genotype 2 or 3).|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 100 subjects in each group would provide over 97% power to detect at least 20% improvement in SVR12 rate from the assumed null rate of 25% using 2-sided exact 1-sample binomial test at significance level of 0.025.||-10.3|-34.4|< 0.001
74073891|NCT02334722|147700273|SUPERIORITY||Median Difference (Final Values)|-2.5||||0.7824|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7824
74073892|NCT00686959|147700297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.831|TWO_SIDED|95.0|0.79|1.2|||Log Rank|||||1.20|0.79|0.831
74073893|NCT00686959|147700298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.13|TWO_SIDED|95.0|0.71|1.04|||Log Rank|||||1.04|0.71|0.130
74073894|NCT00686959|147700299|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED||||||Log Rank|||||||0.458
74073895|NCT00686959|147700302|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Fisher Exact|||Relapsed within the radiation treatment field||||0.132
74073896|NCT00686959|147700302|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED||||||Fisher Exact|||Relapsed inside thorax, outside of radiation field||||0.337
74073897|NCT00686959|147700302|SUPERIORITY_OR_OTHER|||||||0.457|TWO_SIDED||||||Fisher Exact|||Relapsed distant disease||||0.457
74073898|NCT00686959|147700303|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Fisher Exact|||||||0.150
74073899|NCT01212874|147700315|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
74073900|NCT01212874|147700316|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
74073901|NCT03221374|147700352|OTHER|Linear mixed effect model to test the overall BCI learning between MBSR and control groups||||||0.003||||||The threshold for statistical analysis was p = 0.05.|Mixed Models Analysis|||||||0.003
74073902|NCT03221374|147700352|EQUIVALENCE|This independent t-test will test if the two groups (MBSR, control) exhibit a statistically significant difference in terms of BCI performance from baseline.|Mean Difference (Net)|8.98||||0.024|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|t-test, 2 sided||The difference between BCI performance improvement in MBSR cohort and control cohort.|||||0.024
74073903|NCT03221374|147700353|EQUIVALENCE|This WRS test will determine if the MBSR group breath counting accuracy was significantly greater than the postintervention levels of controls.|Mean Difference (Net)|15.4|||<|0.001|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
74073904|NCT03221374|147700354|EQUIVALENCE|The null hypothesis is that the FMI scores of the two groups have equal medians.|Mean Difference (Final Values)|7.9|||<|0.01|TWO_SIDED|||||significant if p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
74073905|NCT03221374|147700354|EQUIVALENCE|The null hypothesis is that the MAAS scores of the two groups have equal medians.|Mean Difference (Final Values)|0.69|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74073906|NCT03221374|147700354|OTHER|This statistical test is about the correlation between baseline up-down BCI performance and the FMI score. A linear regression model is used to test if the slope is non-zero.|correlation coefficient|0.42|||<|0.05|TWO_SIDED|||||significant if p\<0.05|Regression, Linear|||||||<0.05
74073907|NCT03221374|147700354|OTHER|This statistical test is about the correlation between baseline up-down BCI performance and the MAAS score. A linear regression model is used to test if the slope is non-zero.|correlation coefficient|0.41|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
74073908|NCT04166032|147700365|OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.210
74073909|NCT02268500|147700423|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
74073910|NCT02268500|147700424|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.43
74073911|NCT02268500|147700425|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
74073912|NCT02268500|147700426|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
74073913|NCT02268500|147700427|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
74073914|NCT01706536|147700433|SUPERIORITY||Least Squares Mean (SE)|0.1168|STANDARD_ERROR_OF_MEAN|0.04055||0.0043|TWO_SIDED|95.0|0.0369|0.1966|||Least squares mean (SE)|In order to control for Type I error rate, a gate keeping methodology was used.||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.1966|0.0369|0.0043
74073915|NCT01706536|147700433|SUPERIORITY||Least Squares Mean (SE)|0.1284|STANDARD_ERROR_OF_MEAN|0.04089||0.0019|TWO_SIDED|95.0|0.0479|0.2089||In order to control for Type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2089|0.0479|0.0019
74073916|NCT01706536|147700433|SUPERIORITY||Least Squares Mean (SE)|0.1462|STANDARD_ERROR_OF_MEAN|0.04037||0.0004|TWO_SIDED|95.0|0.0667|0.2257||in order to control for Type 1 error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2257|0.0667|0.0004
74073917|NCT01706536|147700433|SUPERIORITY||Least Squares Mean (SE)|0.177|STANDARD_ERROR_OF_MEAN|0.03953|<|0.0001|TWO_SIDED|95.0|0.0992|0.2548||in order to control for type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2548|0.0992|<0.0001
74073918|NCT00993187|147700449|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.8|||<|0.001|TWO_SIDED|95.0|-1.0|-0.6|||ANCOVA|||||-0.6|-1.0|<0.001
74073919|NCT00993187|147700452|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-23.5|||<|0.001|TWO_SIDED|95.0|-30.0|-16.9|||ANCOVA|||||-16.9|-30.0|<0.001
74073920|NCT00993187|147700453|SUPERIORITY_OR_OTHER||Difference in percent|-14.7|||<|0.001|TWO_SIDED|95.0|-23.0|-7.0|||ANCOVA|||||-7.0|-23.0|<0.001
74073921|NCT00993187|147700454|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.72|||<|0.001|TWO_SIDED|95.0|-2.2|-1.25|||ANCOVA|||||-1.25|-2.20|<0.001
74073922|NCT00993187|147700455|SUPERIORITY_OR_OTHER||Difference in percent|41.01|||<|0.001|TWO_SIDED|95.0|30.0|51.0|||ANCOVA|||||51.0|30.0|<0.001
74073923|NCT01507051|147700537|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio|2.793|||<|0.0001||90.0|2.633|2.962|||ANOVA|||||2.962|2.633|<0.0001
74073924|NCT01507051|147700538|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio|6.151|||<|0.0001||90.0|5.598|6.759|||ANOVA|||||6.759|5.598|<0.0001
74073925|NCT01507051|147700565|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|95.17||||0.5008||95.0|82.2|110.2|||ANOVA|||||110.2|82.20|0.5008
74073926|NCT01507051|147700566|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|99.46||||0.9429||95.0|85.47|115.7|||ANOVA|||||115.7|85.47|0.9429
74073927|NCT01507051|147700567|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|100.4||||0.9525||95.0|88.0|114.5|||ANOVA|||||114.5|88.00|0.9525
74073928|NCT01507051|147700568|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|95.87||||0.4397||95.0|85.99|106.9|||ANOVA|||||106.9|85.99|0.4397
74073929|NCT00420303|147700579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47||||0.029||95.0|-32.93|-2.01|||ANCOVA|Treatment groups as fixed factors, baseline value as covariate||Comparison of adjusted means||-2.01|-32.93|0.029
74073930|NCT00420303|147700580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.02||95.0|1.44|69.26|||Generalized estimating equations (GEE)|Logit link, a binomial distribution and an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors.||||69.26|1.44|0.02
74073931|NCT00420303|147700581|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANCOVA|Treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||||||0.007
74073932|NCT04455633|147700623|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.249||0.007|TWO_SIDED|95.0|-1.16|-0.18|||MMRM model|||Mixed model repeated measures (MMRM) model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.||-0.18|-1.16|0.007
74073933|NCT04455633|147700623|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.254||0.03|TWO_SIDED|95.0|-1.06|-0.05|||MMRM model|||MMRM model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.||-0.05|-1.06|0.030
74073934|NCT04455633|147700624|SUPERIORITY||Difference in Percentage of Responders|9.6||||0.091|TWO_SIDED|95.0|-1.55|20.76|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% confidence interval (CI) are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||20.76|-1.55|0.091
74073935|NCT04455633|147700624|SUPERIORITY||Difference in Percentage of Responders|-0.8||||0.883|TWO_SIDED|95.0|-10.95|9.4|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||9.40|-10.95|0.883
74073936|NCT04455633|147700625|SUPERIORITY||Difference in Percentage of Responders|4.8||||0.289|TWO_SIDED|95.0|-4.11|13.73|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||13.73|-4.11|0.289
74073937|NCT04455633|147700625|SUPERIORITY||Difference in Percentage of Responders|-0.8||||0.837|TWO_SIDED|95.0|-8.85|7.16|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||7.16|-8.85|0.837
74073938|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.298||0.014|TWO_SIDED|95.0|-1.32|-0.15|||MMRM model|||Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.||-0.15|-1.32|0.014
74073939|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.017|TWO_SIDED|95.0|-1.27|-0.13|||MMRM model|||Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.||-0.13|-1.27|0.017
74073940|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.302||0.015|TWO_SIDED|95.0|-1.33|-0.15|||MMRM model|||Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.||-0.15|-1.33|0.015
74073941|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.294||0.02|TWO_SIDED|95.0|-1.27|-0.11|||MMRM model|||Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.||-0.11|-1.27|0.020
74073942|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.309||0.005|TWO_SIDED|95.0|-1.48|-0.27|||MMRM model|||Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.||-0.27|-1.48|0.005
74073943|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.301||0.111|TWO_SIDED|95.0|-1.07|0.11|||MMRM model|||Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.||0.11|-1.07|0.111
74073944|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.31||0.399|TWO_SIDED|95.0|-0.87|0.35|||MMRM model|||Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.||0.35|-0.87|0.399
74073945|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.302||0.441|TWO_SIDED|95.0|-0.83|0.36|||MMRM model|||Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.||0.36|-0.83|0.441
74073946|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.346||0.575|TWO_SIDED|95.0|-0.87|0.49|||MMRM model|||General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.||0.49|-0.87|0.575
74073947|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.337||0.88|TWO_SIDED|95.0|-0.71|0.61|||MMRM model|||General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.||0.61|-0.71|0.880
74073948|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.368||0.978|TWO_SIDED|95.0|-0.73|0.71|||MMRM model|||Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.||0.71|-0.73|0.978
74073949|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.358||0.877|TWO_SIDED|95.0|-0.65|0.76|||MMRM model|||Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.||0.76|-0.65|0.877
74073950|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.354||0.079|TWO_SIDED|95.0|-1.32|0.07|||MMRM model|||Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.||0.07|-1.32|0.079
74073951|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.345||0.163|TWO_SIDED|95.0|-1.16|0.2|||MMRM model|||Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.||0.20|-1.16|0.163
74073952|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.344||0.875|TWO_SIDED|95.0|-0.73|0.62|||MMRM model|||Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.||0.62|-0.73|0.875
74073953|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.335||0.914|TWO_SIDED|95.0|-0.69|0.62|||MMRM model|||Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.||0.62|-0.69|0.914
74073954|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.351||0.219|TWO_SIDED|95.0|-0.26|1.12|||MMRM model|||Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.||1.12|-0.26|0.219
74073955|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.341||0.551|TWO_SIDED|95.0|-0.47|0.87|||MMRM model|||Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.||0.87|-0.47|0.551
74073956|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.339||0.005|TWO_SIDED|95.0|-1.63|-0.3|||MMRM model|||Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.||-0.30|-1.63|0.005
74073957|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.329||0.002|TWO_SIDED|95.0|-1.68|-0.39|||MMRM model|||Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.||-0.39|-1.68|0.002
74073958|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.361||0.955|TWO_SIDED|95.0|-0.73|0.69|||MMRM model|||Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.||0.69|-0.73|0.955
74073959|NCT04455633|147700626|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.351||0.777|TWO_SIDED|95.0|-0.79|0.59|||MMRM model|||Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.||0.59|-0.79|0.777
74073960|NCT04455633|147700628|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.163||0.031|TWO_SIDED|95.0|-0.67|-0.03|||ANOVA|||Analysis of variance (ANOVA) model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.||-0.03|-0.67|0.031
73884211|NCT02977403|147302156|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.0002|||||TWO_SIDED|95.0|-0.091|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.091|
73884212|NCT02977403|147302156|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.004|||||TWO_SIDED|95.0|-0.157|0.149||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.149|-0.157|
73888362|NCT03594110|147309575|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin. Two-sided significance level of \<0.0097 required at interim analysis.|Hazard Ratio (HR)|0.86||||0.0022|TWO_SIDED|99.03|0.76|0.98|||Joint frailty model||Comparison vs. Placebo|Hazard ratio (HR) of the time to occurrences of all-cause hospitalizations (first and recurrent combined). HR based on an analysis of recurrent events accounting for terminal events using a joint frailty model with terms for age, log(local screening UACR), local screening Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), treatment, sex, screening diabetes status, region.||0.98|0.76|0.0022
74073961|NCT04455633|147700628|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.165||0.351|TWO_SIDED|95.0|-0.48|0.17|||ANOVA|||ANOVA model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.||0.17|-0.48|0.351
74073962|NCT00445003|147700664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|||<|0.001|TWO_SIDED|95.0|2.2|9.0||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparison|||9.0|2.2|<.001
74073963|NCT00445003|147700664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||<|0.001|TWO_SIDED|95.0|3.2|10.1||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparisons|||10.1|3.2|<.001
73884213|NCT02977403|147302157|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.01|||||TWO_SIDED|95.0|-0.092|0.071||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.071|-0.092|
73884214|NCT02977403|147302157|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.029|||||TWO_SIDED|95.0|-0.126|0.183||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.183|-0.126|
73884215|NCT02977403|147302158|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.013|||||TWO_SIDED|95.0|-0.101|0.076||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.076|-0.101|
73884216|NCT02977403|147302158|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.106|||||TWO_SIDED|95.0|-0.273|0.06||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.060|-0.273|
73884217|NCT02977403|147302159|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.033|||||TWO_SIDED|95.0|-0.11|0.043||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.043|-0.110|
73884218|NCT02977403|147302159|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.166|||||TWO_SIDED|95.0|-0.335|0.003||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.003|-0.335|
73884219|NCT02977403|147302160|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.011|||||TWO_SIDED|95.0|-0.069|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.069|
74073964|NCT00445003|147700666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.0|||<|0.01|TWO_SIDED|95.0|-64.0|-6.0||Adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-6|-64|<.01
74073965|NCT00445003|147700666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-100.0|||<|0.001|TWO_SIDED|95.0|-128.0|-71.0||adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-71|-128|<.001
74073966|NCT00445003|147700668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.44|TWO_SIDED|95.0|-3.7|7.5||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||7.5|-3.7|0.44
73884220|NCT02977403|147302160|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.167|||||TWO_SIDED|95.0|-0.332|-0.002||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.002|-0.332|
73888363|NCT03594110|147309576|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0290 required at interim analysis."|Hazard Ratio (HR)|0.87||||0.2122|TWO_SIDED|97.1|0.68|1.11|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to death from any cause. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||1.11|0.68|0.2122
74073967|NCT00445003|147700668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.63|TWO_SIDED|95.0|-4.4|6.8||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||6.8|-4.4|0.63
74073968|NCT00445003|147700671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.001|TWO_SIDED|95.0|-1.0|-0.2||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-0.2|-1.0|0.001
74073969|NCT00445003|147700671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.1|-1.3||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-1.3|-2.1|<.001
74073970|NCT03553823|147700710|SUPERIORITY||Difference secukinumab vs guselkumab|20.0||||0.1715|TWO_SIDED|95.0|-13.3|50.3|||Fisher Exact|The statistical model was the Fisher's exact test for the difference in proportions.||"Proportion of subjects whose plaque achieves clear or almost clear status (TCS = 0-2)"||50.3|-13.3|0.1715
74073971|NCT03603314|147700717|SUPERIORITY|||||||0.3419|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3419
74073972|NCT03603314|147700717|SUPERIORITY|||||||0.5181|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.5181
74073973|NCT03603314|147700718|SUPERIORITY|||||||0.3666|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3666
74073974|NCT03603314|147700718|SUPERIORITY|||||||0.5776|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.5776
74073975|NCT03603314|147700719|SUPERIORITY|||||||0.4094|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4094
74073976|NCT03603314|147700719|SUPERIORITY|||||||0.4602|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4602
74073977|NCT03603314|147700720|SUPERIORITY|||||||0.1269|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.1269
74073978|NCT03603314|147700720|SUPERIORITY|||||||0.2257|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.2257
74073979|NCT03603314|147700721|SUPERIORITY|||||||0.3121|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3121
74073980|NCT03603314|147700721|SUPERIORITY|||||||0.4965|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4965
74073981|NCT03603314|147700722|SUPERIORITY|||||||0.0976|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.0976
74073982|NCT03603314|147700722|SUPERIORITY|||||||0.1762|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.1762
74073983|NCT04625114|147700771|SUPERIORITY||Mean Difference (Final Values)|1.183||||0.511|TWO_SIDED||||||Mixed Models Analysis|||||||0.511
74073984|NCT04625114|147700772|SUPERIORITY||Cox Proportional Hazard|0.965||||0.921|TWO_SIDED|95.0|0.48|1.942|||Regression, Cox|||||1.942|0.480|0.921
74073985|NCT02567968|147700802|SUPERIORITY|||||||0.002|||||||paired t-test|||||||0.002
74073986|NCT00336479|147700811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.985||||0.0014|TWO_SIDED|95.0|1.525|5.842|||Regression, Logistic|Treatment, weight, race and baseline HCV RNA as factors||||5.842|1.525|0.0014
74073987|NCT00336479|147700811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0204|TWO_SIDED|95.0|1.127|4.178|||Regression, Logistic|||||4.178|1.127|0.0204
74073988|NCT00336479|147700812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.586||||0.0051|TWO_SIDED|95.0|1.331|5.025|||Regression, Logistic|||||5.025|1.331|0.0051
74073989|NCT00336479|147700812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.976||||0.0418|TWO_SIDED|95.0|1.026|3.807|||Regression, Logistic|||||3.807|1.026|0.0418
74073990|NCT02597101|147700820|OTHER|REML mixed model|REML mixed model|0.05|||<|0.05|TWO_SIDED|||||Using REML mixed model analysis, differences between study arms resulting in a p\<0.05 would represent statistically-significant differences.|REML mixed model|||The primary efficacy endpoint is the improvement of insulin sensitivity by 40% or greater at 6 months compared to baseline, assessed by the hyperinsulinemic-euglycemic clamp method.||||<0.05
74073991|NCT01395030|147700831|OTHER||||||||||||||||||"Analysis was performed using Gene Set Enrichment Analysis (GSEA version 19.0.24, Broad Institute, Cambridge, MA) implemented in GenePattern (Broad Institute, Cambridge, MA) by uploading expression array data to this cloud-computing genomics platform. The specific details of this statistical approach can be found in the following publicly available references:~Reich M, Liefeld T, Gould J, Lerner J, Tamayo P, Mesirov JP. GenePattern 2.0 Nature Genetics 38 no. 5 (2006): pp500-501~Subramanian A, Tamayo P, Mootha VK, Mukherjee S, Ebert BL, Gillette MA, Paulovich A, Pomeroy SL, Golub TR, Lander ES, Mesirov JP. Gene set enrichment analysis: A knowledge-based approach for interpreting genome-wide expression profiles. PNAS. 2005;102(43);15545-15550."|||
74073992|NCT02079766|147700834|OTHER|||||||0.2959||||||No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.|Fisher Exact|||Evaluated the association between the overall brain uptake and the study group||||0.2959
74073993|NCT02079766|147700835|OTHER|||||||0.5163||||||No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.|ANOVA|MMSE score as the response variable and flortaucipir uptake score (4 levels) as the fixed effect||Measured differences in clinical presentation using MMSE between subjects with no visual flortaucipir uptake, and those with mild uptake.||||0.5163
74073994|NCT02373098|147700836|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||CCL5=RANTES||||0.000
74073995|NCT02373098|147700836|OTHER|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||IL17A||||0.035
74073996|NCT02373098|147700836|OTHER|||||||0.911|||||||Wilcoxon (Mann-Whitney)|||CXCL13||||0.911
74073997|NCT02373098|147700836|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||IL6||||1.000
74073998|NCT02373098|147700836|OTHER|||||||0.934|||||||Wilcoxon (Mann-Whitney)|||IL8||||0.934
74073999|NCT02373098|147700836|OTHER|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||IL13||||0.727
74074000|NCT02373098|147700836|OTHER|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||IL23||||0.179
74074001|NCT02373098|147700836|OTHER|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||VLA4||||0.208
74074002|NCT02373098|147700836|OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||CXCL10=IP-10 (CXCR3 ligand)||||0.730
74074003|NCT02373098|147700836|OTHER|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||CCL2=MCP-1||||0.725
74074004|NCT02373098|147700836|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||IL4||||0.057
74074005|NCT02373098|147700836|OTHER|||||||0.724|||||||Wilcoxon (Mann-Whitney)|||TNF alpha||||0.724
74074006|NCT02373098|147700836|OTHER|||||||0.662|||||||Wilcoxon (Mann-Whitney)|||IL22||||0.662
74074007|NCT02373098|147700837|OTHER|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||CD3 abs||||0.256
74074008|NCT02373098|147700837|OTHER|||||||0.587|||||||Wilcoxon (Mann-Whitney)|||CD19 abs||||0.587
74074009|NCT02373098|147700837|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||NK abs||||0.300
74074010|NCT02373098|147700837|OTHER|||||||0.096|||||||Wilcoxon (Mann-Whitney)|||NKT abs||||0.096
74074011|NCT02373098|147700837|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 abs||||0.270
74074012|NCT02373098|147700837|OTHER|||||||0.902|||||||Wilcoxon (Mann-Whitney)|||CD4CD25||||0.902
74074013|NCT02373098|147700837|OTHER|||||||0.283|||||||Wilcoxon (Mann-Whitney)|||Hi CD4CD25||||0.283
74074014|NCT02373098|147700840|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD3 %||||0.017
74074015|NCT02373098|147700840|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||CD19 %||||0.300
74074016|NCT02373098|147700840|OTHER|||||||0.657|||||||Wilcoxon (Mann-Whitney)|||NK %||||0.657
74074017|NCT02373098|147700840|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||NKT %||||0.439
74074018|NCT02373098|147700840|OTHER|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 %||||0.449
74074019|NCT02373098|147700840|OTHER|||||||0.356|||||||Wilcoxon (Mann-Whitney)|||CD3CD4||||0.356
74074020|NCT02373098|147700840|OTHER|||||||0.787|||||||Wilcoxon (Mann-Whitney)|||CD3CD8||||0.787
74074021|NCT02373098|147700840|OTHER|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||CD3CD4||||0.121
74074022|NCT02373098|147700840|OTHER|||||||0.209|||||||Wilcoxon (Mann-Whitney)|||CD3CD8||||0.209
74074023|NCT02373098|147700840|OTHER|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||CD4+IFNg+ (in CD4+)||||0.069
74074024|NCT02373098|147700840|OTHER|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||CD4+IL17+ (in CD4+)||||0.402
74074025|NCT02373098|147700840|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IFNg+ (in CD8+)||||0.017
74074026|NCT02373098|147700840|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IL17+ (in CD8+)||||0.017
74074027|NCT02373098|147700840|OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||IFNg+ (in CD4+CD25+)||||0.026
74074028|NCT02373098|147700840|OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||IL17+ (in CD4+CD25+)||||0.168
74074029|NCT02373098|147700840|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||CD4+IL10+ (in CD4+)||||0.004
74074030|NCT02373098|147700840|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD4+IL4+ (in CD4+)||||0.013
74074031|NCT02373098|147700840|OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||CD4-CD8-IL4+ (in CD4-CD8-)||||0.171
74074032|NCT02373098|147700840|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL10+ (in CD8+)||||0.013
74074033|NCT02373098|147700840|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL4+ (in CD8+)||||0.013
74074034|NCT02373098|147700840|OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||IL10+ (in CD4+CD25+)||||0.007
74074035|NCT02373098|147700840|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||IL4+ (in CD4+CD25+)||||0.001
74074036|NCT02373098|147700840|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||CD4+TNFa+ (in CD4+)||||0.002
74074037|NCT02373098|147700840|OTHER|||||||0.107|||||||Wilcoxon (Mann-Whitney)|||CD4+IL9+ (in CD4+)||||0.107
74074038|NCT02373098|147700840|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||CD8+TNFa+ (in CD8+)||||0.000
74074039|NCT02373098|147700840|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||CD8+IL9+ (in CD8+)||||0.022
74074040|NCT02373098|147700840|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||TNFa+ (in CD4+CD25+)||||0.001
74074041|NCT02373098|147700840|OTHER|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||IL9+ (in CD4+CD25+)||||0.127
74074042|NCT03117569|147700873|NON_INFERIORITY|A total of 375 participants (2:1 randomisation) were planned for enrolment and evaluation as ITT population. Under the assumption that SVR12 rate would be 96% in both arms, the study had 80% power to show non-inferiority of the simplified monitoring strategy with a lower confidence bound for SVR12 in the simplified monitoring arm greater than 90% or with a lower confidence bound for the difference (simplified arm minus standard arm) in SVR12 greater than -6%.|Difference in Percentage of Participants|-3.2|||<|0.05|TWO_SIDED|95.0|-8.2|1.8|||t-test, 2 sided|||||1.8|-8.2|<0.05
74074043|NCT03018249|147700946|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
74074044|NCT03018249|147700947|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|-25.0|30.0||||||||30|-25|
74074045|NCT03018249|147700948|SUPERIORITY||Mean Difference (Final Values)|21.8|||||TWO_SIDED|95.0|-16.7|45.3||||||||45.3|-16.7|
74074046|NCT01312922|147700995|SUPERIORITY||Odds Ratio (OR)|0.987||||1|TWO_SIDED|95.0|0.456|2.14|||Fisher Exact|||||2.140|0.456|1.000
74074047|NCT01312922|147700995|SUPERIORITY||Odds Ratio (OR)|1.031||||1|TWO_SIDED|95.0|0.476|2.233|||Fisher Exact|||||2.233|0.476|1.000
74074048|NCT02227121|147701001|SUPERIORITY_OR_OTHER||Percentage|92.86|||||ONE_SIDED|95.0|70.3|||||||Null Hypothesis: Percentage of Subjects with Successful VF Termination ≤ 65% Alternative Hypothesis: Percentage of Subjects with Successful VF Termination \> 65%|||70.3|
74074049|NCT03929367|147701002|OTHER|Modeling of change of plasma oxytocin concentration over time using nonlinear canonical compartment model.|Bayesian information criterion|2.0|||||TWO_SIDED|||||||||||||
74074050|NCT03929367|147701013|SUPERIORITY|Light touch detection frequency was compared over time in comparison to baseline using a one way analysis of variance for repeated measures. A power analysis was not performed for this secondary outcome measure.||||||0.89||||||No effect|ANOVA|||||||.89
74074051|NCT03929367|147701020|SUPERIORITY|Sustained heat score at the end of each 5 minute session was compared to baseline across time using a one-way analysis of variance for repeated measures. Power analysis was not performed for this secondary outcome measure.||||||0.014|||||||ANOVA|||||||0.014
74074052|NCT00515203|147701044|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Cochran-Mantel-Haenszel|||||||0.0019
74074053|NCT00515203|147701045|SUPERIORITY_OR_OTHER|||||||0.3651|||||||Cochran-Mantel-Haenszel|||||||0.3651
74074054|NCT00515203|147701046|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Fisher Exact|||||||0.0008
74074055|NCT00515203|147701047|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Fisher Exact|||||||0.0008
74074056|NCT00515203|147701048|SUPERIORITY_OR_OTHER|||||||0.2098|||||||Fisher Exact|||||||0.2098
74074057|NCT01402947|147701074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.013|||||TWO_SIDED|90.0|0.933|1.1|||ANOVA|||||1.100|0.933|
74074058|NCT01402947|147701075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.999|||||TWO_SIDED|90.0|0.893|1.117|||ANOVA|||||1.117|0.893|
74074059|NCT02801877|147701078|SUPERIORITY|||||||0.3|||||||Log Rank|Chi square= 4.1 on 3 degrees of freedom||Log-rank test of adherence, defined as time to last engagement with mobile application suite.||||0.3
74074060|NCT02801877|147701079|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|F(3, 835)=0.19||Interactive effect of time and group, adjusting for baseline PHQ-9, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.||||0.90
74074061|NCT02801877|147701080|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|F(3, 835)=0.73||Interactive effect of time and group, adjusting for baseline GAD-7, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.||||0.53
74074062|NCT00154102|147701081|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.853||||0.0479|TWO_SIDED|95.0|0.728|1.0|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The study was planned with 633 progression events, in order to provide 80% power to test the null hypothesis of no difference in PFS time between treatment groups, assuming a hazard ratio (HR) of 0.8 of cetuximab + chemotherapy (CTX) over CTX alone. Significance level was fixed at 5%. The two-sided stratified log-rank test was employed, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and Karnovsky Performance Scale (KPS):\<80 vs. ≥80)||1.000|0.728|0.0479
74074063|NCT00154102|147701082|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.696||||0.0012|TWO_SIDED|95.0|0.558|0.867|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.867|0.558|0.0012
74074064|NCT00154102|147701083|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.2648|TWO_SIDED|95.0|0.887|1.544|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.544|0.887|0.2648
74074065|NCT00154102|147701084|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.0419|TWO_SIDED|95.0|0.774|0.995|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.995|0.774|0.0419
74074066|NCT00154102|147701085|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.0093|TWO_SIDED|95.0|0.67|0.946|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.946|0.670|0.0093
74074067|NCT00154102|147701086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.7549|TWO_SIDED|95.0|0.834|1.284|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.284|0.834|0.7549
74074068|NCT00154102|147701087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.0038|TWO_SIDED|95.0|1.12|1.77|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.77|1.12|0.0038
74074069|NCT00154102|147701088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.069|||<|0.0001|TWO_SIDED|95.0|1.515|2.826|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||2.826|1.515|<0.0001
74074070|NCT00154102|147701089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.3475|TWO_SIDED|95.0|0.544|1.242|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.242|0.544|0.3475
74074071|NCT00154102|147701090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.6004|TWO_SIDED|95.0|0.67|1.26|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.26|0.67|0.6004
73888519|NCT05465317|147309654|OTHER||Hazard Ratio (HR)|0.8||||0.32|TWO_SIDED|95.0|0.51|1.24|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.24|0.51|0.32
74074072|NCT00154102|147701092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.002|TWO_SIDED|95.0|1.45|6.27|||Cochran-Mantel-Haenszel|||||6.27|1.45|0.002
74074073|NCT04349917|147701098|SUPERIORITY|||||||0.532|||||||t-test, 2 sided|||||||0.532
74074074|NCT04349917|147701099|SUPERIORITY|||||||0.579|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.579
74074075|NCT04349917|147701099|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.034
74074076|NCT04349917|147701100|SUPERIORITY|||||||0.296|||||||t-test, 2 sided|||Analysis for reconfiguration between rest and GNG regular task||||0.296
74074077|NCT04349917|147701100|SUPERIORITY|||||||0.169|||||||t-test, 2 sided|||Analysis for reconfiguration between rest and GNG reward task||||0.169
74074078|NCT04349917|147701101|SUPERIORITY|||||||0.118|||||||Pearson correlation|||Change in rest modularity vs change in GNG regular commission rate||||0.118
74074079|NCT04349917|147701101|SUPERIORITY|||||||0.022|||||||Pearson correlation|||Change in rest modularity vs change in GNG regular omission rate||||0.022
74074080|NCT04349917|147701101|SUPERIORITY|||||||0.22|||||||Pearson correlation|||Change in rest modularity vs Change in GNG regular RT Variability||||0.220
74074081|NCT04349917|147701101|SUPERIORITY|||||||0.496|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward commission rate||||0.496
74074082|NCT04349917|147701101|SUPERIORITY|||||||0.343|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward omission rate||||0.343
74074083|NCT04349917|147701101|SUPERIORITY|||||||0.988|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward RT variability||||0.988
74074084|NCT04349917|147701101|SUPERIORITY|||||||0.892|||||||Pearson correlation|||Change in GNG regular modularity vs change in GNG regular commission rate||||0.892
74074085|NCT04349917|147701101|SUPERIORITY|||||||0.473|||||||Pearson correlation|||Change in GNG regular modularity vs change in GNG regular omission rate||||0.473
73888364|NCT03594110|147309577|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.81|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.81|0.62|<0.0001
73888520|NCT05465317|147309654|OTHER||Hazard Ratio (HR)|0.96||||0.81|TWO_SIDED|95.0|0.71|1.3|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.30|0.71|0.81
74074086|NCT04349917|147701101|SUPERIORITY|||||||0.409|||||||Pearson correlation|||Change in GNG regular modularity vs Change in GNG regular RT Variability||||0.409
74074087|NCT04349917|147701101|SUPERIORITY|||||||0.351|||||||Pearson correlation|||Change in GNG reward modularity vs change in GNG reward commission rate||||0.351
74074088|NCT04349917|147701101|SUPERIORITY|||||||0.238|||||||Pearson correlation|||Change in GNG reward modularity vs change in GNG reward omission rate||||0.238
74074089|NCT04349917|147701101|SUPERIORITY|||||||0.909|||||||Pearson correlation|||Change in GNG reward modularity vs Change in GNG reward RT Variability||||0.909
74074090|NCT04349917|147701102|SUPERIORITY|||||||0.806|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.806
74074091|NCT04349917|147701102|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.003
74074092|NCT04349917|147701103|SUPERIORITY|||||||0.093|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.093
74074093|NCT04349917|147701103|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.0001
74074094|NCT04349917|147701104|SUPERIORITY|||||||0.075|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.075
74074095|NCT04349917|147701104|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.0001
74074096|NCT00485472|147701112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.36||||0.5438||95.0|-5.3|10.02|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||10.02|-5.30|0.5438
74074097|NCT00485472|147701113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.83||||0.2022||95.0|-2.62|12.28|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||12.28|-2.62|0.2022
74074098|NCT00485472|147701114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.79||||0.665||95.0|-6.36|9.93|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||9.93|-6.36|0.6650
74074099|NCT00485472|147701115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.74||||0.3445||95.0|-11.65|33.13|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||33.13|-11.65|0.3445
74074100|NCT00485472|147701117|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.488||||0.0418||95.0|0.245|0.974|||Likelihood ratio test|||Analysis of 'response' based on a likelihood ratio test with treatment and pooled site as factors.||0.974|0.245|0.0418
74074101|NCT01029353|147701150|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.87|1.14|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis. Model included treatment, baseline risk of death or NDI, and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) as covariates.||1.14|0.87|
74074102|NCT01029353|147701150|OTHER|||||||0.03||||||Pre-specified threshold = 0.05|Robust Poisson regression|||A frequentist analysis. Using Robust Poisson regression with log link and center as repeated measure, and effect coding, test for an interaction between treatment (Initial Laparotomy/Initial Peritoneal Drain) and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) as covariates. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-operative diagnosis as covariates.||||0.03
74074103|NCT01029353|147701150|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.82, 1.11).|||
74074104|NCT01029353|147701150|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.75|1.26|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariate.|A frequentist analysis. Model included treatment, baseline risk of death or NDI, and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) covariates.||1.26|0.75|
74074105|NCT01029353|147701151|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.69|1.45|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.45|0.69|
74074106|NCT01029353|147701151|SUPERIORITY|A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|||||||||||||||||Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.69, 1.30).|||
74074107|NCT01029353|147701152|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.78|1.34|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis. Estimate based on model fit using only data from study survivors.||1.34|0.78|
74074108|NCT01029353|147701152|SUPERIORITY|||||||||||||||||A Bayesian analysis among study survivors. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.99, 95% credible interval of (0.78, 1.25).|||
74074109|NCT01029353|147701153|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.66|1.06|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.06|0.66|
74074110|NCT01029353|147701153|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.65, 1.02).|||
74074111|NCT01029353|147701154|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.89|1.18|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.18|0.89|
74074112|NCT01029353|147701154|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.98, 95% credible interval of (0.84, 1.15).|||
74074113|NCT01029353|147701155|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.64|1.31|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.31|0.64|
74074114|NCT01029353|147701155|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.86, 95% credible interval of (0.64, 1.16).|||
74074115|NCT01029353|147701156|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.69|1.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.36|0.69|
74074116|NCT01029353|147701156|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.92, 95% credible interval of (0.68, 1.25).|||
74074117|NCT01029353|147701157|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.35|0.63|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||0.63|0.35|
74074118|NCT01029353|147701157|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.51, 95% credible interval of (0.37, 0.69).|||
74074119|NCT01029353|147701158|SUPERIORITY||Risk Ratio (RR)|1.57|||||TWO_SIDED|95.0|1.04|2.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.36|1.04|
74074120|NCT01029353|147701158|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.45, 95% credible interval of (0.92, 2.31).|||
74074121|NCT01029353|147701159|SUPERIORITY||Risk Ratio (RR)|1.58|||||TWO_SIDED|95.0|0.71|3.5|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||3.50|0.71|
73884221|NCT02977403|147302161|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.054|||||TWO_SIDED|95.0|-0.037|0.146||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.146|-0.037|
73884222|NCT02977403|147302161|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.019|||||TWO_SIDED|95.0|-0.127|0.09||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.090|-0.127|
73884223|NCT02977403|147302162|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.002|||||TWO_SIDED|95.0|-0.061|0.065||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.065|-0.061|
73884224|NCT02977403|147302162|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.086|||||TWO_SIDED|95.0|-0.215|0.042||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.042|-0.215|
73884225|NCT02977403|147302163|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.032|||||TWO_SIDED|95.0|-0.05|0.115||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.115|-0.05|
73884226|NCT02977403|147302163|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.248|0.058||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.058|-0.248|
73884227|NCT02977403|147302164|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.075|0.042||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.042|-0.075|
73884228|NCT02977403|147302164|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.025|||||TWO_SIDED|95.0|-0.13|0.18||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.180|-0.130|
73884229|NCT02977403|147302165|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.03|||||TWO_SIDED|95.0|-0.039|0.099||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).||||Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.099|-0.039|
74074122|NCT01029353|147701159|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.31, 95% credible interval of (0.66, 2.62).|||
74074123|NCT01029353|147701160|SUPERIORITY|||||||||||||||||A frequentist analysis.|This analysis used model identical to other by treatment analyses for binary outcome. RR estimated from robust Poisson regression with log link, reference cell coding, center as repeated measure. RR: Initial Laparotomy over Peritoneal Drain. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates. However, adjusted RR estimates could not be calculated due to the iteration limit being excessed in PROC GENMOD.|||
74074124|NCT01029353|147701160|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.16, 95% credible interval of (0.50, 2.65).|||
74074125|NCT01029353|147701161|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.34|2.2|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.20|0.34|
74074126|NCT01029353|147701161|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.93, 95% credible interval of (0.45, 1.91).|||
74074127|NCT01029353|147701162|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.37|1.42|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.42|0.37|
74074128|NCT01029353|147701162|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.75, 95% credible interval of (0.48, 1.16).|||
74074129|NCT01029353|147701163|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.15|0.70|
73884230|NCT02977403|147302165|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.143|||||TWO_SIDED|95.0|-0.335|0.049||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.049|-0.335|
73884231|NCT02977403|147302166|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.097|0.066||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.066|-0.097|
73884232|NCT02977403|147302166|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.162|||||TWO_SIDED|95.0|-0.314|-0.01||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.01|-0.314|
73884233|NCT02977403|147302167|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.053|||||TWO_SIDED|95.0|-0.051|0.156||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.156|-0.051|
73884234|NCT02977403|147302167|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.07|||||TWO_SIDED|95.0|-0.251|0.111||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.111|-0.251|
73884235|NCT02977403|147302168|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.015|||||TWO_SIDED|95.0|-0.061|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.061|
74074130|NCT01029353|147701163|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.91, 95% credible interval of (0.65, 1.27).|||
74074131|NCT01029353|147701164|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.44|1.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.36|0.44|
74074132|NCT01029353|147701164|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.49, 1.33).|||
74074133|NCT01029353|147701165|SUPERIORITY||Mean Difference (Final Values)|-6.01|||||TWO_SIDED|95.0|-12.77|0.75|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||0.75|-12.77|
73884236|NCT02977403|147302168|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.108|||||TWO_SIDED|95.0|-0.26|0.044||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.044|-0.260|
73884237|NCT02977403|147302169|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.036|||||TWO_SIDED|95.0|-0.047|0.119||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.119|-0.047|
73884238|NCT02977403|147302169|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.106|||||TWO_SIDED|95.0|-0.276|0.064||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.064|-0.276|
74074134|NCT01029353|147701165|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -2.68, 95% credible interval of (-7.11, 1.83).|||
73884239|NCT02977403|147302170|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.017|||||TWO_SIDED|95.0|-0.092|0.057||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.057|-0.092|
74074135|NCT01029353|147701166|SUPERIORITY||Mean Difference (Final Values)|-8.75|||||TWO_SIDED|95.0|-17.05|-0.46|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||-0.46|-17.05|
74074136|NCT01029353|147701166|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -3.23, 95% credible interval of (-8.08, 1.68).|||
74074137|NCT01029353|147701167|SUPERIORITY||Mean Difference (Final Values)|6.59|||||TWO_SIDED|95.0|-9.09|22.27|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||22.27|-9.09|
74074138|NCT01029353|147701167|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was 1.65, 95% credible interval of (-3.97, 7.23).|||
74074139|NCT01029353|147701168|SUPERIORITY||Mean Difference (Final Values)|-2.56|||||TWO_SIDED|95.0|-13.02|7.91|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||7.91|-13.02|
73884240|NCT02977403|147302170|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.002|||||TWO_SIDED|95.0|-0.15|0.153||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.153|-0.150|
73884241|NCT02977403|147302171|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.07|||||TWO_SIDED|95.0|-0.019|0.159||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.159|-0.019|
73884242|NCT02977403|147302171|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.26|0.07||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.070|-0.260|
73884243|NCT02977403|147302172|SUPERIORITY||beta coefficient|-0.8707|STANDARD_ERROR_OF_MEAN|0.766||0.256|TWO_SIDED||||||Generalized estimation equations||Reported variable is a condition by time (pre or post-intervention) interaction term. The model included a Poisson distribution, log link function, exchangeable covariance matrix and was adjusted for age, fat mass, height, and race and ethnicity.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||||0.256
73884244|NCT03563209|147302194|OTHER||||||<|0.001||||||p-value was adjusted for multiple comparisons. A priori threshold for statistical significance was set to 0.05/3 (0.0167)|Friedman|||Null hypothesis: no difference between dynamic components of elbow flexor spasticity (spasticity angle) in three different forearm positions. (Comparison groups were Spasticity angle in pronation, Spasticity angle in neutral position and Spasticity angle in supination)||||<0.001
73884245|NCT03593044|147302238|OTHER|||||||0.002|||||||t-test, 2 sided|||Photopic pupil size||||0.002
73884246|NCT03593044|147302238|OTHER|||||||0.66|||||||t-test, 2 sided|||Mesopic pupil size||||0.66
73884247|NCT03593044|147302239|OTHER|||||||0.96|||||||t-test, 2 sided|||High contrast distance visual acuity||||0.96
73884248|NCT03593044|147302239|OTHER|||||||0.77|||||||t-test, 2 sided|||High contrast near visual acuity||||0.77
73884249|NCT03593044|147302239|OTHER|||||||0.82|||||||t-test, 2 sided|||Low contrast distance visual acuity||||0.82
73884250|NCT03593044|147302240|OTHER|||||||0.1|||||||t-test, 2 sided|||Accommodative amplitude||||0.10
73884251|NCT03593044|147302240|OTHER|||||||0.66|||||||t-test, 2 sided|||Accommodative lag||||0.66
73884252|NCT03593044|147302240|OTHER|||||||0.24|||||||t-test, 2 sided|||Accommodative facility||||0.24
73884253|NCT03593044|147302241|OTHER|||||||0.3|||||||t-test, 2 sided|||Glare||||0.3
73884254|NCT03593044|147302241|OTHER|||||||0.5|||||||t-test, 2 sided|||Ghost images||||0.5
73884255|NCT03593044|147302241|OTHER|||||||0.9|||||||t-test, 2 sided|||Strain/tiredness||||0.9
73884256|NCT03593044|147302241|OTHER|||||||0.9|||||||t-test, 2 sided|||Changing vision||||0.9
73884257|NCT03593044|147302241|OTHER|||||||0.3|||||||t-test, 2 sided|||Headache frequency||||0.3
73884258|NCT03593044|147302241|OTHER|||||||0.7|||||||t-test, 2 sided|||Distance clarity||||0.7
73884259|NCT03593044|147302241|OTHER|||||||0.3|||||||t-test, 2 sided|||Computer clarity||||0.3
73884260|NCT03593044|147302241|OTHER|||||||0.1|||||||t-test, 2 sided|||Small print clarity||||0.1
73884261|NCT03593044|147302241|OTHER|||||||1|||||||t-test, 2 sided|||Vision during sports/hobbies||||1.0
73884262|NCT03593044|147302241|OTHER|||||||0.2|||||||t-test, 2 sided|||Overall vision||||0.2
73884263|NCT03593044|147302241|OTHER|||||||0.7|||||||t-test, 2 sided|||Light sensitivity||||0.7
73884264|NCT03593044|147302241|OTHER|||||||0.002|||||||t-test, 2 sided|||Discomfort during bright light||||0.002
73884265|NCT03593044|147302242|OTHER|||||||0.001|||||||t-test, 2 sided|||Right eye intraocular pressure||||0.001
73884266|NCT03593044|147302242|OTHER|||||||0.05|||||||t-test, 2 sided|||Left eye intraocular pressure||||0.05
73884267|NCT01766050|147302244|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.898|1.093||||||||1.093|0.898|
74074140|NCT01029353|147701168|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -0.71, 95% credible interval of (-5.89, 4.48).|||
74074141|NCT01029353|147701169|SUPERIORITY||Mean Difference (Final Values)|-13.95|||||TWO_SIDED|95.0|-30.54|2.63|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.63|-30.54|
74074142|NCT01029353|147701169|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -1.78, 95% credible interval of (-7.44, 3.87).|||
74074143|NCT01029353|147701170|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.64|1.04|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.04|0.64|
74074144|NCT01029353|147701170|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.95|1.31|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.31|0.95|
74074145|NCT01029353|147701170|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.81, 95% credible interval of (0.63, 1.00). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.09, 95% credible interval of (0.90, 1.33).|||
74074146|NCT01029353|147701171|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.52|1.13|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.13|0.52|
74074147|NCT01029353|147701171|SUPERIORITY||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.79|2.06|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.06|0.79|
74074148|NCT01029353|147701171|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.53, 1.20). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.18, 95% credible interval of (0.74, 1.87).|||
74074149|NCT01029353|147701172|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.42|1.27|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.27|0.42|
74074150|NCT01029353|147701172|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.85|1.45|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.45|0.85|
74074151|NCT01029353|147701172|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Pre-operative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.76, 95% credible interval of (0.48, 1.18). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.08, 95% credible interval of (0.83, 1.42).|||
74074152|NCT01029353|147701173|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.47|1.05|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.05|0.47|
74074153|NCT01029353|147701173|SUPERIORITY||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.76|1.19|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.19|0.76|
74074154|NCT01029353|147701173|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.73, 95% credible interval of (0.52, 0.96). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.68, 1.32).|||
74074155|NCT01029353|147701174|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.61|1.06|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.06|0.61|
74074156|NCT01029353|147701174|SUPERIORITY||Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|1.01|1.37|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.37|1.01|
74074157|NCT01029353|147701174|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.80, 95% credible interval of (0.61, 1.01). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.15, 95% credible interval of (0.94, 1.42).|||
73884268|NCT01766050|147302244|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.911|||||TWO_SIDED|90.0|0.83|1.0||||||||1.000|0.830|
74074158|NCT01029353|147701175|SUPERIORITY||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.46|1.01|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.01|0.46|
74074159|NCT01029353|147701175|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.74|2.01|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.01|0.74|
74074160|NCT01029353|147701175|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.72, 95% credible interval of (0.48, 1.05). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.12, 95% credible interval of (0.71, 1.76).|||
74074161|NCT01029353|147701176|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.51|1.04|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.04|0.51|
74074162|NCT01029353|147701176|SUPERIORITY||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.82|1.93|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates. Reported results in this analysis restricted to infants with IP.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.93|0.82|
74074163|NCT01029353|147701176|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.77, 95% credible interval of (0.51, 1.14). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.17, 95% credible interval of (0.76, 1.81).|||
74074164|NCT01029353|147701177|SUPERIORITY||Risk Ratio (RR)|0.53|||||TWO_SIDED|95.0|0.31|0.89|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||0.89|0.31|
73884269|NCT01766050|147302244|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.994|||||TWO_SIDED|90.0|0.885|1.116||||||||1.116|0.885|
73884270|NCT01766050|147302262|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.976|1.13||||||AUC (0-T)||1.130|0.976|
73884271|NCT01766050|147302262|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.966|||||TWO_SIDED|90.0|0.889|1.049||||||AUC (0-T)||1.049|0.889|
73884272|NCT01766050|147302262|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.033|||||TWO_SIDED|90.0|0.95|1.123||||||AUC (0-T)||1.123|0.950|
73884273|NCT01766050|147302262|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.049|||||TWO_SIDED|90.0|0.975|1.127||||||AUC (INF)||1.127|0.975|
74074165|NCT01029353|147701177|SUPERIORITY||Risk Ratio (RR)|0.44|||||TWO_SIDED|95.0|0.29|0.66|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||0.66|0.29|
74074166|NCT01029353|147701178|SUPERIORITY||Risk Ratio (RR)|1.44|||||TWO_SIDED|95.0|0.58|3.57|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||3.57|0.58|
74074167|NCT01029353|147701178|SUPERIORITY||Risk Ratio (RR)|1.63|||||TWO_SIDED|95.0|1.06|2.5|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.50|1.06|
74074168|NCT01029353|147701179|SUPERIORITY||Risk Ratio (RR)|2.52|||||TWO_SIDED|95.0|0.84|7.55|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||7.55|0.84|
74074169|NCT01029353|147701179|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.38|2.88|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.88|0.38|
74074170|NCT01029353|147701180|SUPERIORITY||Risk Ratio (RR)|1.78|||||TWO_SIDED|95.0|0.82|3.86|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||3.86|0.82|
74074171|NCT01029353|147701180|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.42|3.2|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||3.20|0.42|
74074172|NCT01029353|147701181|SUPERIORITY||Risk Ratio (RR)|1.68|||||TWO_SIDED|95.0|0.35|8.05|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||8.05|0.35|
74074173|NCT01029353|147701181|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.1|2.44|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.44|0.10|
73884274|NCT01766050|147302262|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.968|||||TWO_SIDED|90.0|0.892|1.049||||||AUC (INF)||1.049|0.892|
73884275|NCT01766050|147302262|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.031|||||TWO_SIDED|90.0|0.948|1.121||||||AUC(INF)||1.121|0.948|
73884276|NCT01766050|147302263|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.898|1.093||||||||1.093|0.898|
73884277|NCT01766050|147302263|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.911|||||TWO_SIDED|90.0|0.83|1.0||||||||1.000|0.830|
73884278|NCT01766050|147302263|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.994|||||TWO_SIDED|90.0|0.885|1.116||||||||1.116|0.885|
73884279|NCT01766050|147302264|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.013|||||TWO_SIDED|90.0|0.944|1.088||||||AUC (0-T)||1.088|0.944|
73884280|NCT01766050|147302264|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.016|||||TWO_SIDED|90.0|0.936|1.103||||||AUC (0-T)||1.103|0.936|
73884281|NCT01766050|147302264|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.001|||||TWO_SIDED|90.0|0.893|1.121||||||AUC (0-T)||1.121|0.893|
73884282|NCT01766050|147302264|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.011|||||TWO_SIDED|90.0|0.942|1.085||||||AUC (INF)||1.085|0.942|
73884283|NCT01766050|147302264|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.016|||||TWO_SIDED|90.0|0.938|1.101||||||AUC (INF)||1.101|0.938|
73884284|NCT01766050|147302264|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.002|||||TWO_SIDED|90.0|0.896|1.121||||||AUC (INF)||1.121|0.896|
73884285|NCT01766050|147302265|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.26|||||TWO_SIDED|90.0|1.118|1.421||||||||1.421|1.118|
73884286|NCT01766050|147302265|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.292|||||TWO_SIDED|90.0|1.09|1.531||||||||1.531|1.090|
73884287|NCT01766050|147302265|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.178|||||TWO_SIDED|90.0|0.971|1.429||||||||1.429|0.971|
73884288|NCT01766050|147302266|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.159|||||TWO_SIDED|90.0|1.056|1.272||||||AUC (0-T)||1.272|1.056|
73884289|NCT01766050|147302266|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.228|||||TWO_SIDED|90.0|1.092|1.381||||||AUC (0-T)||1.381|1.092|
73884290|NCT01766050|147302266|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.215|||||TWO_SIDED|90.0|1.047|1.41||||||AUC (0-T)||1.410|1.047|
73884291|NCT01766050|147302266|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.193|||||TWO_SIDED|90.0|1.091|1.304||||||AUC (INF)||1.304|1.091|
73884292|NCT01766050|147302266|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.227|||||TWO_SIDED|90.0|1.093|1.379||||||AUC (INF)||1.379|1.093|
73884293|NCT01766050|147302266|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.3|||||TWO_SIDED|90.0|1.141|1.482||||||AUC (INF)||1.482|1.141|
73884294|NCT01766050|147302267|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.863|||||TWO_SIDED|90.0|0.746|0.997||||||||0.997|0.746|
73884295|NCT01766050|147302267|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.922|||||TWO_SIDED|90.0|0.793|1.071||||||||1.071|0.793|
73884296|NCT01766050|147302267|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.856|||||TWO_SIDED|90.0|0.709|1.034||||||||1.034|0.709|
73884297|NCT01766050|147302268|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.915|||||TWO_SIDED|90.0|0.817|1.024||||||AUC (0-T)||1.024|0.817|
73884298|NCT01766050|147302268|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.003|||||TWO_SIDED|90.0|0.856|1.175||||||AUC (0-T)||1.175|0.856|
73884299|NCT01766050|147302268|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.963|||||TWO_SIDED|90.0|0.821|1.13||||||AUC (0-T)||1.130|0.821|
73884300|NCT01766050|147302268|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.877|||||TWO_SIDED|90.0|0.783|0.982||||||AUC (INF)||0.982|0.783|
73884301|NCT01766050|147302268|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.031|||||TWO_SIDED|90.0|0.885|1.2||||||AUC (INF)||1.200|0.885|
73884302|NCT01766050|147302268|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.022|||||TWO_SIDED|90.0|0.839|1.245||||||AUC (INF)||1.245|0.839|
73884303|NCT01766050|147302269|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.948|||||TWO_SIDED|90.0|0.88|1.021||||||||1.021|0.880|
73884304|NCT01766050|147302269|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.922|||||TWO_SIDED|90.0|0.857|0.993||||||||0.993|0.857|
73884305|NCT01766050|147302269|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.954|||||TWO_SIDED|90.0|0.885|1.028||||||||1.028|0.885|
73884306|NCT01766050|147302270|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.941|||||TWO_SIDED|90.0|0.874|1.013||||||AUC (0-T)||1.013|0.874|
73884307|NCT01766050|147302270|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.986|||||TWO_SIDED|90.0|0.902|1.076||||||AUC (0-T)||1.076|0.902|
73884308|NCT01766050|147302270|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.027|||||TWO_SIDED|90.0|0.942|1.12||||||AUC (0-T)||1.120|0.942|
73884309|NCT01766050|147302270|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.939|||||TWO_SIDED|90.0|0.868|1.017||||||AUC (INF)||1.017|0.868|
73884310|NCT01766050|147302270|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.002|||||TWO_SIDED|90.0|0.914|1.098||||||||1.098|0.914|
73884311|NCT01766050|147302270|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.036|||||TWO_SIDED|90.0|0.94|1.142||||||AUC (INF)||1.142|0.940|
73884312|NCT03577275|147302280|OTHER|||||||||||||||||"The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect \> 10 msec at clinically relevant icosabutate plasma concentrations.~Assay sensitivity was evaluated by concentration-QTc analysis of the effect on delta delta QTcF of moxifloxacin using a similar model as for the primary analysis."|The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect \> 10 msec at clinically relevant icosabutate plasma concentrations.|||
73884313|NCT02535481|147302366|SUPERIORITY|||||||0.366||||||At 6 weeks|Fisher Exact|||||||0.366
73884314|NCT02535481|147302366|SUPERIORITY|||||||0.24||||||At 3 months|Fisher Exact|||||||0.24
74074174|NCT01029353|147701182|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.62|2.69|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||2.69|0.62|
74074175|NCT01029353|147701182|SUPERIORITY||Risk Ratio (RR)|0.6|||||TWO_SIDED|95.0|0.27|1.32|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.32|0.27|
74074176|NCT01029353|147701183|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.41|1.36|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.36|0.41|
74074177|NCT01029353|147701183|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.69|1.42|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.42|0.69|
74074178|NCT01029353|147701184|SUPERIORITY||Risk Ratio (RR)|0.43|||||TWO_SIDED|95.0|0.04|4.45|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||4.45|0.04|
74074179|NCT01029353|147701184|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.44|1.49|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.49|0.44|
74074180|NCT01029353|147701185|SUPERIORITY||Mean Difference (Final Values)|-1.27|||||TWO_SIDED|95.0|-14.1|11.6|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||11.60|-14.10|
74074181|NCT01029353|147701185|SUPERIORITY||Mean Difference (Final Values)|-7.85|||||TWO_SIDED|95.0|-15.84|0.13|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||0.13|-15.84|
73884315|NCT02535481|147302367|SUPERIORITY||||||<|0.0001|||||||Log Rank|Kaplan-Meier analysis of cumulative wound healing followed by a log rank test||||||<0.0001
73884316|NCT02535481|147302368|SUPERIORITY|||||||0.12|||||||Log Rank|||||||0.12
73884317|NCT02535481|147302369|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73884318|NCT02535481|147302370|SUPERIORITY|||||||0.001||||||At 6 weeks|Wilcoxon (Mann-Whitney)|||||||0.001
73884319|NCT02535481|147302370|SUPERIORITY|||||||0.001||||||At 3 months|Wilcoxon (Mann-Whitney)|||||||0.001
73884320|NCT02764385|147302376|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|1.73|2.01||||||||2.01|1.73|
73884321|NCT02764385|147302376|SUPERIORITY||Odds Ratio (OR)|0.68||||0.05|TWO_SIDED|95.0|0.45|1.02|||Regression, Logistic|We adjust for clustering of visit within clinician and clinical site and the stepped wedge study design using generalized estimating equation methods.||||1.02|.45|.05
73884322|NCT02764385|147302377|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|1.73|2.1||||||||2.10|1.73|
73884323|NCT02177695|147302416|SUPERIORITY||Odds Ratio (OR)|2.63||||0.1|TWO_SIDED|95.0|0.82|8.36|||Regression, Logistic|||To determine the relationship of GC COXEN scores to pT0, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the GC treatment group.||8.36|0.82|0.1
73884324|NCT02177695|147302416|SUPERIORITY||Odds Ratio (OR)|1.12||||0.82|TWO_SIDED|95.0|0.42|2.95|||Regression, Logistic|||To determine the relationship of ddMVAC COXEN scores to pT0, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the ddMVAC treatment group.||2.95|0.42|0.82
73884325|NCT02177695|147302417|SUPERIORITY||Odds Ratio (OR)|2.33||||0.02|TWO_SIDED|95.0|1.11|4.89|||Regression, Logistic|||To determine the relationship of GC COXEN scores to \<= pT1, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the GC treatment group.||4.89|1.11|0.02
73884326|NCT02177695|147302417|SUPERIORITY||Odds Ratio (OR)|0.9||||0.76|TWO_SIDED|95.0|0.46|1.75|||Regression, Logistic|||To determine the relationship of ddMVAC COXEN scores to \<=pT1, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the ddMVAC treatment group.||1.75|0.46|0.76
73884327|NCT00286468|147302452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for glycosylated hemoglobin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per-protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level, and \>=80% of subjects meeting per protocol criteria.||-0.19|-0.59|<0.001
73884328|NCT00286468|147302452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.73|-0.33||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per-protocol criteria.||-0.33|-0.73|<0.001
73884329|NCT00286468|147302453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001|TWO_SIDED|95.0|-0.33|-0.13||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.13|-0.33|<0.001
73884330|NCT00286468|147302453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.38|-0.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.18|-0.38|<0.001
74074182|NCT01029353|147701186|SUPERIORITY||Mean Difference (Final Values)|-11.57|||||TWO_SIDED|95.0|-27.15|4.01|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||4.01|-27.15|
73884331|NCT00286468|147302454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.53|-0.26||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.26|-0.53|<0.001
73884332|NCT00286468|147302454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.61|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.61|<0.001
73884333|NCT00286468|147302455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.001|TWO_SIDED|95.0|-0.57|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.25|-0.57|<0.001
73884334|NCT00286468|147302455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.68|-0.36||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.68|<0.001
73884335|NCT00286468|147302456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.001|TWO_SIDED|95.0|-0.54|-0.19||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.19|-0.54|<0.001
73884336|NCT00286468|147302456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.68|<0.001
73884337|NCT00286468|147302457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.17||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.17|-0.54|<0.001
73884338|NCT00286468|147302457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.71|-0.34||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.71|<0.001
73884339|NCT00286468|147302458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1||||0.006|TWO_SIDED|95.0|-20.8|-3.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-3.4|-20.8|0.006
73884340|NCT00286468|147302458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.001|TWO_SIDED|95.0|-28.0|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.6|-28.0|<0.001
73884341|NCT00286468|147302459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|||<|0.001|TWO_SIDED|95.0|-22.5|-7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-7.2|-22.5|<0.001
73884342|NCT00286468|147302459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0|||<|0.001|TWO_SIDED|95.0|-27.7|-12.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.4|-27.7|<0.001
73884343|NCT00286468|147302460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.01|TWO_SIDED|95.0|-19.3|-2.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.6|-19.3|0.010
73884344|NCT00286468|147302460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.8|-9.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.1|-25.8|<0.001
73884345|NCT00286468|147302461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-25.2|-8.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.2|-25.2|<0.001
74074183|NCT01029353|147701186|SUPERIORITY||Mean Difference (Final Values)|-7.63|||||TWO_SIDED|95.0|-17.46|2.2|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||2.20|-17.46|
73884346|NCT00286468|147302461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|||<|0.001|TWO_SIDED|95.0|-23.9|-6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.9|-23.9|<0.001
73884347|NCT00286468|147302462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1||||0.03|TWO_SIDED|95.0|-19.2|-1.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.0|-19.2|0.030
73884348|NCT00286468|147302462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7||||0.012|TWO_SIDED|95.0|-20.8|-2.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.5|-20.8|0.012
73884349|NCT00286468|147302463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.701|TWO_SIDED|95.0|-11.6|7.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.8|-11.6|0.701
73884350|NCT00286468|147302463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.228|TWO_SIDED|95.0|-15.7|3.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.7|-15.7|0.228
74074184|NCT01029353|147701187|SUPERIORITY||Mean Difference (Final Values)|4.0|||||TWO_SIDED|95.0|-18.84|26.83|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||26.83|-18.84|
74074185|NCT01029353|147701187|SUPERIORITY||Mean Difference (Final Values)|9.05|||||TWO_SIDED|95.0|-13.29|31.38|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||31.38|-13.29|
74074186|NCT01029353|147701188|SUPERIORITY||Mean Difference (Final Values)|-3.13|||||TWO_SIDED|95.0|-24.62|18.36|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||18.36|-24.62|
74074187|NCT01029353|147701188|SUPERIORITY||Mean Difference (Final Values)|-2.39|||||TWO_SIDED|95.0|-14.42|9.63|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates. Reported results in this analysis restricted to infants with IP.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||9.63|-14.42|
74074188|NCT01029353|147701189|SUPERIORITY||Mean Difference (Final Values)|-18.43|||||TWO_SIDED|95.0|-48.41|11.55|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||11.55|-48.41|
74074189|NCT01029353|147701189|SUPERIORITY||Mean Difference (Final Values)|-11.95|||||TWO_SIDED|95.0|-31.96|8.06|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||8.06|-31.96|
74074190|NCT01287013|147701195|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74074191|NCT01287013|147701196|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74074192|NCT01287013|147701197|OTHER||||||<|0.04|||||||t-test, 2 sided|||||||<0.04
74074193|NCT01287013|147701198|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74074194|NCT01287013|147701199|SUPERIORITY_OR_OTHER||||||=|0.67|||||||t-test, 2 sided|||||||=0.67
74074195|NCT03203447|147701203|SUPERIORITY||Difference in percentages|-7.1||||0.191|TWO_SIDED|95.0|-17.9|3.6||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.||3.6|-17.9|0.191
74074196|NCT00528606|147701206|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||p-value based on Cochran-Mantel-Haenszel test comparing treatment groups, stratified by baseline severity group and joint type.||||<0.001
73884351|NCT00286468|147302464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0||||0.097|TWO_SIDED|95.0|-19.6|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.6|-19.6|0.097
73884352|NCT00286468|147302464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3||||0.014|TWO_SIDED|95.0|-23.9|-2.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.7|-23.9|0.014
73884353|NCT00286468|147302465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8||||0.241|TWO_SIDED|95.0|-18.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-18.3|0.241
73884354|NCT00286468|147302465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.5||||0.072|TWO_SIDED|95.0|-22.0|0.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.9|-22.0|0.072
73884355|NCT00286468|147302466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.775||||0.338|TWO_SIDED|95.0|0.46|1.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.306|0.460|0.338
73884356|NCT00286468|147302466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.521||||0.016|TWO_SIDED|95.0|0.306|0.887||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.887|0.306|0.016
73884357|NCT00286468|147302467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.374||||0.003|TWO_SIDED|95.0|0.194|0.72||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.720|0.194|0.003
73884358|NCT00286468|147302467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.372||||0.003|TWO_SIDED|95.0|0.193|0.718||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.718|0.193|0.003
73884359|NCT00286468|147302468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.923|TWO_SIDED|95.0|-6.1|6.7||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.7|-6.1|0.923
73884360|NCT00286468|147302468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.259|TWO_SIDED|95.0|-2.7|10.1||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||10.1|-2.7|0.259
73884361|NCT00286468|147302469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.916|TWO_SIDED|95.0|-6.6|5.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.9|-6.6|0.916
73884362|NCT00286468|147302469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.305|TWO_SIDED|95.0|-3.0|9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.5|-3.0|0.305
73884363|NCT00286468|147302470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.953|TWO_SIDED|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.1|0.953
73884364|NCT00286468|147302470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.957|TWO_SIDED|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.1|0.957
73884365|NCT00286468|147302471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.908|TWO_SIDED|95.0|-5.9|6.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.6|-5.9|0.908
73884366|NCT00286468|147302471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.826|TWO_SIDED|95.0|-5.6|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.0|-5.6|0.826
73884367|NCT00286468|147302472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.894|TWO_SIDED|95.0|-5.9|6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.8|-5.9|0.894
73884368|NCT00286468|147302472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.432|TWO_SIDED|95.0|-3.8|8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||8.9|-3.8|0.432
73884369|NCT00286468|147302473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.548|TWO_SIDED|95.0|-8.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.3|-8.1|0.548
73884370|NCT00286468|147302473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.986|TWO_SIDED|95.0|-6.3|6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.2|-6.3|0.986
73884371|NCT00286468|147302474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26||||0.415|TWO_SIDED|95.0|-1.78|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.30|-1.78|0.415
73884372|NCT00286468|147302474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.332|TWO_SIDED|95.0|-1.54|4.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.55|-1.54|0.332
73884373|NCT00286468|147302475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.89|TWO_SIDED|95.0|-2.47|2.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.85|-2.47|0.890
74074197|NCT00050778|147701223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24||||0.0006|TWO_SIDED|95.0|0.11|0.545||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.545|0.110|0.0006
74074198|NCT00050778|147701223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.0021|TWO_SIDED|95.0|0.151|0.658||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.658|0.151|0.0021
74074199|NCT00050778|147701223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.152|0.515|||Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.515|0.152|<0.0001
74074200|NCT00050778|147701224|SUPERIORITY_OR_OTHER||Rate ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.196|0.552||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.552|0.196|<0.0001
73884374|NCT00286468|147302475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.38|TWO_SIDED|95.0|-1.48|3.86||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.86|-1.48|0.380
73884375|NCT00286468|147302476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35||||0.448|TWO_SIDED|95.0|-2.14|4.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.85|-2.14|0.448
73884376|NCT00286468|147302476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.568|TWO_SIDED|95.0|-2.48|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.52|-2.48|0.568
74074201|NCT00050778|147701224|SUPERIORITY_OR_OTHER||Rate ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.126|0.431||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.431|0.126|<0.0001
74074202|NCT00050778|147701224|SUPERIORITY_OR_OTHER||Rate ratio|0.28|||<|0.0001|TWO_SIDED|95.0|0.176|0.441|||Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.441|0.176|<0.0001
74074203|NCT00050778|147701225|SUPERIORITY_OR_OTHER||Treatment effect|62.64||||0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||0.0001
74074204|NCT00050778|147701225|SUPERIORITY_OR_OTHER||Treatment effect|76.71|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||<0.0001
74074205|NCT00050778|147701225|SUPERIORITY_OR_OTHER||Treatment effect|70.13|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||<0.0001
74074206|NCT00050778|147701226|SUPERIORITY_OR_OTHER|||||||0.0885|||||||ANCOVA|||Ranked analysis of covariance (ANCOVA) model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0885
74074207|NCT00050778|147701226|SUPERIORITY_OR_OTHER|||||||0.0195|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0195
74074208|NCT00050778|147701226|SUPERIORITY_OR_OTHER|||||||0.0215|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0215
74074209|NCT00050778|147701227|SUPERIORITY_OR_OTHER|||||||0.3077|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.3077
74074210|NCT00050778|147701227|SUPERIORITY_OR_OTHER|||||||0.3632|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.3632
74074211|NCT00050778|147701227|SUPERIORITY_OR_OTHER|||||||0.2758|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.2758
74074212|NCT00064753|147701230|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.99||||0.93|TWO_SIDED|95.0|0.84|1.17||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.17|0.84|0.93
74074213|NCT00064753|147701231|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.15||||0.19|TWO_SIDED|95.0|0.93|1.43||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.43|0.93|0.19
74074214|NCT00064753|147701232|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.67|TWO_SIDED|95.0|0.86|1.26||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.26|0.86|0.67
74074215|NCT00064753|147701233|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.08||||0.61|TWO_SIDED|95.0|0.8|1.45||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.45|0.80|0.61
74074216|NCT00064753|147701234|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.12||||0.64|TWO_SIDED|95.0|0.69|1.81||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.81|0.69|0.64
74074217|NCT00064753|147701235|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.66|TWO_SIDED|95.0|0.3|2.15||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||2.15|0.30|0.66
74074218|NCT00064753|147701236|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.28|TWO_SIDED|95.0|0.62|1.15|||Regression, Cox|||||1.15|0.62|0.28
74074219|NCT00064753|147701237|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.7|TWO_SIDED|95.0|0.73|1.23|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||1.23|0.73|0.70
74074220|NCT00064753|147701238|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.49|TWO_SIDED|95.0|0.79|1.65|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||1.65|0.79|0.49
74074221|NCT00064753|147701239|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.78|TWO_SIDED|95.0|0.46|2.8|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||2.80|0.46|0.78
74074222|NCT00064753|147701240|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61||||0.5|TWO_SIDED|95.0|0.15|2.57|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||2.57|0.15|0.50
74074223|NCT00064753|147701241|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3||||0.6|TWO_SIDED|95.0|0.48|3.5|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||3.50|0.48|0.60
74074224|NCT03834870|147701251|OTHER||Percentage of enrolled from eligible|84.05|||||TWO_SIDED|95.0|81.98|86.1||||||||86.10|81.98|
74074225|NCT03834870|147701252|OTHER||Percentage of enrolled from eligible|99.01|||||TWO_SIDED|95.0|98.4|99.6||||||||99.60|98.40|
73884377|NCT00286468|147302477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.95||||0.077|TWO_SIDED|95.0|-0.32|6.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.22|-0.32|0.077
73884378|NCT00286468|147302477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.303|TWO_SIDED|95.0|-1.55|4.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.99|-1.55|0.303
73884379|NCT00286468|147302478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.461|TWO_SIDED|95.0|-2.08|4.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.57|-2.08|0.461
73884380|NCT00286468|147302478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99||||0.559|TWO_SIDED|95.0|-2.34|4.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.32|-2.34|0.559
73884381|NCT00286468|147302479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.43|TWO_SIDED|95.0|-1.54|3.62||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.62|-1.54|0.430
73884382|NCT00286468|147302479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.124|TWO_SIDED|95.0|-0.56|4.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.61|-0.56|0.124
74074226|NCT00813293|147701262|SUPERIORITY|||||||0.794|||||||Wilcoxon (Mann-Whitney)|||Assuming the two trial arms were independent, the standard deviation was 0.5cm for both arms and a sample size of 16 evaluable patients (8 per arm), the study had an 84% power at a 5% (two-sided) significance level to detect 0.8cm difference in ablation zone size. In order to allow a 20% drop-out rate, a total of 20 subjects were accrued.||||.794
74074227|NCT00819507|147701284|SUPERIORITY||Mean Difference (Final Values)|6.01|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
74074228|NCT00819507|147701285|SUPERIORITY||Median Difference (Final Values)|14.35|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
74074229|NCT02549092|147701304|SUPERIORITY||Least Squares (LS) Mean of Difference|-8.21|STANDARD_ERROR_OF_MEAN|9.91||0.41|TWO_SIDED|95.0|-27.98|11.55||P value is from the mixed model repeated measures (MMRM) with the model: change from Baseline=treatment, country, visit, Baseline, treatment-by-visit, and Baseline-by-visit. Unstructured variance-covariance structure was used in the MMRM analysis.|mixed model repeated measures|Adjusted for multiplicity using the Hochberg procedure to control the family-wise error rate at a pre-specified significance level (alpha = 0.05).|Difference of LCIG - OMT|||11.55|-27.98|0.410
74074230|NCT02549092|147701305|SUPERIORITY||LS Mean of Difference|1.57|STANDARD_ERROR_OF_MEAN|2.37||0.509|TWO_SIDED|95.0|-3.16|6.3||The P value is from the MMRM with the model: change from Baseline = treatment, country, visit, Baseline, treatment-by-visit, and Baseline-by-visit. The unstructured variance-covariance structure was used in the MMRM analysis.|mixed model repeated measures|Adjusted for multiplicity using the Hochberg procedure to control the family-wise error rate at a pre-specified significance level (alpha = 0.05).|Difference of LCIG - OMT|||6.30|-3.16|0.509
74074231|NCT02549092|147701306|SUPERIORITY||LS mean difference|-3.81|STANDARD_ERROR_OF_MEAN|3.59||0.291|TWO_SIDED|95.0|-10.96|3.34||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||3.34|-10.96|0.291
74074232|NCT02549092|147701307|SUPERIORITY||LS Mean of Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.84|-1.82||Analysis of covariance (ANCOVA) model: FINAL = treatment, country.|ANCOVA||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||-1.82|-2.84|< 0.001
74074233|NCT02549092|147701308|SUPERIORITY||LS mean difference|-2.79|STANDARD_ERROR_OF_MEAN|0.99||0.006|TWO_SIDED|95.0|-4.77|-0.81||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||-0.81|-4.77|0.006
74074234|NCT02549092|147701309|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.99||0.933|TWO_SIDED|95.0|-1.89|2.06||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Cardiovascular including falls||2.06|-1.89|0.933
74074235|NCT02549092|147701309|SUPERIORITY||LS mean difference|1.05|STANDARD_ERROR_OF_MEAN|2.35||0.655|TWO_SIDED|95.0|-3.63|5.74||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Sleep/fatigue||5.74|-3.63|0.655
74074236|NCT02549092|147701309|SUPERIORITY||LS mean difference|-1.85|STANDARD_ERROR_OF_MEAN|3.67||0.616|TWO_SIDED|95.0|-9.18|5.48||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Mood/cognition||5.48|-9.18|0.616
74074237|NCT02549092|147701309|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.84||0.645|TWO_SIDED|95.0|-1.3|2.08||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Perceptual problems/hallucinations||2.08|-1.30|0.645
74074238|NCT02549092|147701309|SUPERIORITY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|2.04||0.645|TWO_SIDED|95.0|-5.03|3.14||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Attention/memory||3.14|-5.03|0.645
74074239|NCT02549092|147701309|SUPERIORITY||LS mean difference|-2.58|STANDARD_ERROR_OF_MEAN|1.34||0.058|TWO_SIDED|95.0|-5.25|0.09||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Gastrointestinal tract||0.09|-5.25|0.058
74074240|NCT02549092|147701309|SUPERIORITY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|2.17||0.588|TWO_SIDED|95.0|-5.52|3.15||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Urinary||3.15|-5.52|0.588
74074241|NCT02549092|147701309|SUPERIORITY||LS mean difference|-0.78|STANDARD_ERROR_OF_MEAN|1.05||0.464|TWO_SIDED|95.0|-2.88|1.33||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Sexual function||1.33|-2.88|0.464
74074242|NCT02549092|147701309|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.76||0.468|TWO_SIDED|95.0|-4.8|2.23||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Miscellaneous||2.23|-4.80|0.468
74074243|NCT02549092|147701310|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.26||0.643|TWO_SIDED|95.0|-3.09|1.92||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Motor symptoms at night||1.92|-3.09|0.643
74074244|NCT02549092|147701310|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.82||0.769|TWO_SIDED|95.0|-1.39|1.87||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|PD symptoms at night||1.87|-1.39|0.769
74074245|NCT02549092|147701310|SUPERIORITY||LS Mean of Difference|1.99|STANDARD_ERROR_OF_MEAN|0.84||0.02|TWO_SIDED|95.0|0.32|3.66||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Disturbed sleep||3.66|0.32|0.020
74074246|NCT02549092|147701311|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|0.46||0.672|TWO_SIDED|95.0|-0.72|1.1||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part I score||1.10|-0.72|0.672
74074247|NCT02549092|147701311|SUPERIORITY||LS Mean of Difference|-2.22|STANDARD_ERROR_OF_MEAN|2.13||0.302|TWO_SIDED|95.0|-6.47|2.04||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part III score||2.04|-6.47|0.302
74074248|NCT02549092|147701311|SUPERIORITY||LS Mean of Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.61||0.007|TWO_SIDED|95.0|-2.91|-0.48||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part IV score||-0.48|-2.91|0.007
74074249|NCT02549092|147701312|SUPERIORITY||LS Mean of Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.5||0.307|TWO_SIDED|95.0|-4.52|1.44||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|||1.44|-4.52|0.307
74074250|NCT02549092|147701313|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.46||0.868|TWO_SIDED|95.0|-0.99|0.84||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|||0.84|-0.99|0.868
74074251|NCT02549092|147701314|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|3.28||0.728|TWO_SIDED|95.0|-7.68|5.39||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Total score||5.39|-7.68|0.728
74074252|NCT02549092|147701314|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.71||0.916|TWO_SIDED|95.0|-1.5|1.35||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Musculoskeletal pain score||1.35|-1.50|0.916
73884383|NCT00286468|147302480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056||||0.011|TWO_SIDED|95.0|-0.099|-0.013||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.013|-0.099|0.011
73884384|NCT00286468|147302480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035||||0.116|TWO_SIDED|95.0|-0.078|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.078|0.116
74074253|NCT02549092|147701314|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.68||0.919|TWO_SIDED|95.0|-1.28|1.42||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Chronic pain score||1.42|-1.28|0.919
74074254|NCT02549092|147701314|SUPERIORITY||LS Mean of Difference|0.63|STANDARD_ERROR_OF_MEAN|1.53||0.68|TWO_SIDED|95.0|-2.42|3.68||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Fluctuation related pain score||3.68|-2.42|0.680
74074255|NCT02549092|147701314|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.24||0.767|TWO_SIDED|95.0|-2.83|2.09||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Nocturnal pain score||2.09|-2.83|0.767
74074256|NCT02549092|147701314|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.51||0.804|TWO_SIDED|95.0|-1.15|0.9||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Orofacial pain score||0.90|-1.15|0.804
74074257|NCT02549092|147701314|SUPERIORITY||LS Mean of Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.79||0.025|TWO_SIDED|95.0|-3.38|-0.23||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Discoloration and edema score||-0.23|-3.38|0.025
74074258|NCT02549092|147701314|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.47||0.93|TWO_SIDED|95.0|-0.99|0.9||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Radicular pain score||0.90|-0.99|0.930
74074259|NCT02549092|147701315|SUPERIORITY||LS Mean of Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.89|-1.87||ANCOVA model: FINAL = treatment, country.|ANCOVA||Difference of LCIG - OMT|||-1.87|-2.89|< 0.001
74074260|NCT02495467|147701329|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.0132|TWO_SIDED|95.0|0.22|1.84|||Mixed Models Analysis|||||1.84|0.22|0.0132
74074261|NCT02495467|147701330|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0122|TWO_SIDED|95.0|0.09|0.73|||Mixed Models Analysis|||||0.73|0.09|0.0122
74074262|NCT02495467|147701331|SUPERIORITY||Mean Difference (Final Values)|0.39|||<|0.0001|TWO_SIDED|95.0|0.21|0.57|||Mixed Models Analysis|||||0.57|0.21|<0.0001
74074263|NCT02495467|147701332|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0055|TWO_SIDED|95.0|0.12|0.69|||Mixed Models Analysis|||||0.69|0.12|0.0055
74074264|NCT02495467|147701333|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.001|TWO_SIDED|95.0|0.2|0.76|||Mixed Models Analysis|||||0.76|0.20|0.001
74074265|NCT02495467|147701334|SUPERIORITY||Means ratio|0.995||||0.7999|TWO_SIDED|95.0|0.96|1.032|||Generalized Linear Mixed Model|||||1.032|0.960|0.7999
74074266|NCT02495467|147701335|SUPERIORITY||Means ratio|0.989||||0.6746|TWO_SIDED|95.0|0.937|1.043|||Generalized Linear Mixed Model|||||1.043|0.937|0.6746
74074267|NCT02495467|147701336|SUPERIORITY||Means ratio|1.075||||0.0959|TWO_SIDED|95.0|0.987|1.17|||Generalized Linear Mixed Model|||||1.170|0.987|0.0959
74074268|NCT02495467|147701337|SUPERIORITY||Means ratio|1.522|||<|0.0001|TWO_SIDED|95.0|1.267|1.829|||Generalized Linear Mixed Model|||||1.829|1.267|<0.0001
74074269|NCT02495467|147701338|SUPERIORITY||Means ratio|1.32||||0.0005|TWO_SIDED|95.0|1.128|1.545|||Generalized Linear Mixed Model|||||1.545|1.128|0.0005
74074270|NCT02495467|147701339|SUPERIORITY||||||<|0.0001|||||||Prescott Test (Exact)|||||||<0.0001
74074271|NCT02495467|147701340|SUPERIORITY|||||||0.0003|||||||Prescott Test (Exact)|||||||0.0003
74074272|NCT02193165|147701344|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different. Significance will be determined by p\<0.5||||0.434
74074273|NCT02193165|147701345|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups determined by P\<0.05||||<0.001
74074274|NCT02193165|147701346|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups will be determined at P\<0.05||||<0.001
74074275|NCT02193165|147701347|SUPERIORITY_OR_OTHER|||||||0.816|TWO_SIDED||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups. Differences will be noted at P\<0.05. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different||||0.816
73884385|NCT00286468|147302481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.024|TWO_SIDED|95.0|-0.081|-0.006||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.006|-0.081|0.024
73884386|NCT00286468|147302481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.059|TWO_SIDED|95.0|-0.074|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.001|-0.074|0.059
73884387|NCT00286468|147302482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028||||0.159|TWO_SIDED|95.0|-0.067|0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.011|-0.067|0.159
73884388|NCT00286468|147302482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038||||0.055|TWO_SIDED|95.0|-0.077|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.001|-0.077|0.055
73884389|NCT00286468|147302483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.062|TWO_SIDED|95.0|-0.08|0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.002|-0.080|0.062
73884390|NCT00286468|147302483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043||||0.041|TWO_SIDED|95.0|-0.084|-0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.002|-0.084|0.041
73884391|NCT00286468|147302484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.148|TWO_SIDED|95.0|-0.069|0.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.010|-0.069|0.148
73884392|NCT00286468|147302484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031||||0.135|TWO_SIDED|95.0|-0.071|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.071|0.135
73884393|NCT00286468|147302485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.177|TWO_SIDED|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.012|-0.065|0.177
73884394|NCT00286468|147302485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.177|TWO_SIDED|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.012|-0.065|0.177
73884395|NCT00286468|147302486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162||||0.324|TWO_SIDED|95.0|-0.161|0.486||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.486|-0.161|0.324
73884396|NCT00286468|147302486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176||||0.284|TWO_SIDED|95.0|-0.147|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.500|-0.147|0.284
73884397|NCT00286468|147302487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268||||0.053|TWO_SIDED|95.0|-0.004|0.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.540|-0.004|0.053
74074276|NCT02193165|147701348|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05||||<0.001
74074277|NCT02193165|147701349|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05||||<0.001
73884398|NCT00286468|147302487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.349||||0.012|TWO_SIDED|95.0|0.077|0.621||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.621|0.077|0.012
73884399|NCT00286468|147302488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.196|TWO_SIDED|95.0|-0.094|0.458||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.458|-0.094|0.196
73884400|NCT00286468|147302488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226||||0.11|TWO_SIDED|95.0|-0.051|0.502||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.502|-0.051|0.110
73884401|NCT00286468|147302489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228||||0.121|TWO_SIDED|95.0|-0.06|0.517||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.517|-0.060|0.121
73884402|NCT00286468|147302489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.28|TWO_SIDED|95.0|-0.13|0.448||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.448|-0.130|0.280
73884403|NCT00286468|147302490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015||||0.924|TWO_SIDED|95.0|-0.29|0.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.320|-0.290|0.924
73884404|NCT00286468|147302490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138||||0.376|TWO_SIDED|95.0|-0.168|0.444||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.444|-0.168|0.376
73884405|NCT00286468|147302491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075||||0.642|TWO_SIDED|95.0|-0.242|0.393||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.393|-0.242|0.642
73884406|NCT00286468|147302491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063||||0.698|TWO_SIDED|95.0|-0.255|0.381||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.381|-0.255|0.698
73884407|NCT00286468|147302492|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.596|TWO_SIDED|95.0|0.503|3.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.306|0.503|0.596
73884408|NCT00286468|147302492|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.148|TWO_SIDED|95.0|0.787|4.885||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.885|0.787|0.148
73884409|NCT00286468|147302493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.925||||0.046|TWO_SIDED|95.0|1.011|3.666||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.666|1.011|0.046
73884410|NCT00286468|147302493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.505||||0.005|TWO_SIDED|95.0|1.313|4.78||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.780|1.313|0.005
73884411|NCT00286468|147302494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.955||||0.025|TWO_SIDED|95.0|1.086|3.519||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.519|1.086|0.025
73884412|NCT00286468|147302494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.707|||<|0.001|TWO_SIDED|95.0|2.012|6.831||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.831|2.012|<0.001
73884413|NCT00286468|147302495|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.994|||<|0.001|TWO_SIDED|95.0|1.72|5.213||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.213|1.720|<0.001
73884414|NCT00286468|147302495|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.401|||<|0.001|TWO_SIDED|95.0|1.95|5.933||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.933|1.950|<0.001
73884415|NCT00286468|147302496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.776||||0.115|TWO_SIDED|95.0|0.87|3.627||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.627|0.870|0.115
73884416|NCT00286468|147302496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.416|||<|0.001|TWO_SIDED|95.0|1.703|6.851||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.851|1.703|<0.001
73884417|NCT00286468|147302497|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.991||||0.986|TWO_SIDED|95.0|0.365|2.689||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||2.689|0.365|0.986
73884418|NCT00286468|147302497|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.131|TWO_SIDED|95.0|0.808|5.203||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.203|0.808|0.131
73884419|NCT00286468|147302498|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.626
73884420|NCT00286468|147302498|SUPERIORITY_OR_OTHER|||||||0.178||||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.178
73884421|NCT00286468|147302499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||<|0.001|TWO_SIDED|95.0|0.32|1.16||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.16|0.32|<0.001
73884422|NCT00286468|147302499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.006|TWO_SIDED|95.0|0.17|1.02||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.02|0.17|0.006
73884423|NCT00286468|147302500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.006|TWO_SIDED|95.0|0.2|1.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.18|0.20|0.006
74074278|NCT00678639|147701370|SUPERIORITY_OR_OTHER||Median cost difference|588.0|||||TWO_SIDED|95.0|336.0|811.0|||Hodges-Lehmann (median cost difference)|Distribution-free 95% CIs calculated using the method of Moses.|Results favored a reduced cost in the OU-CMR group.|H0: The median costs are not different among the study groups. HA: The median cost is different among groups. Power calculation was based on detecting a mean cost difference of $2000. Data was found to be non-normally distributed and therefore nonparametric comparisons were implemented.||811|336|
73884424|NCT00286468|147302500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.04|TWO_SIDED|95.0|0.02|1.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.01|0.02|0.040
73884425|NCT00286468|147302501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.47|1.73||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.73|0.47|<0.001
73884426|NCT00286468|147302501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.005|TWO_SIDED|95.0|0.28|1.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.55|0.28|0.005
73884427|NCT00286468|147302502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.018|TWO_SIDED|95.0|0.14|1.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.46|0.14|0.018
74074279|NCT00678639|147701371|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||"H0: There is no difference in correct cardiovascular admission decisions among groups.~Ha: A difference exists among study groups. Sample size was based upon 47 analyzable participants per study arm were required to provide 88% power to detect a 30% difference in the outcome."||||<0.001
74074280|NCT03611608|147701375|SUPERIORITY||Mean Difference (Final Values)|263.54|||<|0.001|ONE_SIDED|90.0|207.86||||t-test, 1 sided||||||207.86|<0.001
73884428|NCT00286468|147302502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.01|TWO_SIDED|95.0|0.21|1.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.54|0.21|0.010
73884429|NCT03305666|147302503|NON_INFERIORITY|Statistical analyses were conduced using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.12|||||||ANOVA|||||||0.12
73884430|NCT03305666|147302504|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.41|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #1.||||0.41
73884431|NCT03305666|147302504|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.25|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #2.||||0.25
73884432|NCT03305666|147302504|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.12|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #3.||||0.12
73884433|NCT03305666|147302504|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.04|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #4.||||0.04
73884434|NCT03305666|147302504|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.32|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #5.||||0.32
73884435|NCT03305666|147302505|NON_INFERIORITY|Statistical analyses were conduced using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.23|||||||ANOVA|||||||0.23
74074281|NCT00986245|147701379|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.4|||<|0.05|||||||Sign test|||The UPDRS-part3 was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.||||<0.05
74074282|NCT00986245|147701380|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.0|||<|0.05|||||||Sign test|||The Hoehn and Yahr stage was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.||||<0.05
73884436|NCT02135861|147302510|OTHER||Mean Difference (Final Values)|0.16||||0.0029|TWO_SIDED|95.0|0.06|0.26||estimates of total lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2600|0.0600|0.0029
74074283|NCT00986245|147701381|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.3|||<|0.05|||||||Sign test|||"The Overall quality of sleep was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
74074284|NCT00986245|147701382|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.2|||<|0.05|||||||Sign test|||"The Nocturnal off-symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
74074285|NCT00986245|147701383|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||<|0.05||||||80% power|Sign test|||"The Early morning off symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
73884437|NCT02135861|147302510|OTHER||Mean Difference (Final Values)|0.1825||||0.0007|TWO_SIDED|95.0|0.0855|0.2795||estimates of left lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2795|0.0855|0.0007
73884438|NCT02135861|147302510|OTHER||Mean Difference (Final Values)|0.1565||||0.0093|TWO_SIDED|95.0|0.0419|0.2711||estimates of right lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2711|0.0419|0.0093
73884439|NCT02135861|147302510|OTHER||Mean Difference (Final Values)|0.1764||||0.0007|TWO_SIDED|95.0|0.0823|0.2704||estimates of left lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2704|0.0823|0.0007
73884440|NCT02135861|147302510|OTHER||Mean Difference (Final Values)|0.1999||||0.001|TWO_SIDED|95.0|0.0894|0.3103||estimates of left lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.3103|0.0894|0.0010
73884441|NCT02135861|147302510|OTHER||Mean Difference (Final Values)|0.136||||0.0159|TWO_SIDED|95.0|0.0276|0.2443||estimates of right lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2443|0.0276|0.0159
74074286|NCT00986245|147701384|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Final Values)|0.1|||<|0.05|||||||Sign test|||"The Epworth sleep scale was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
73884442|NCT02135861|147302510|OTHER||Mean Difference (Final Values)|0.1748||||0.0064|TWO_SIDED|95.0|0.0535|0.2961||estimates of right lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2961|0.0535|0.0064
74074287|NCT00986245|147701385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|||<|0.05|||||||Sign test|||||||<0.05
74074288|NCT02158494|147701392|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 2 weeks||||0.41
74074289|NCT02158494|147701392|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 14 weeks||||0.47
74074290|NCT02158494|147701392|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 26 weeks||||0.99
74074291|NCT01214850|147701403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.185||||0.3828|TWO_SIDED|95.0|0.809|1.737|||Regression, Logistic|||Vaccine Group Odds Ratios for carriage of virulent ST strain of N. meningitidis group B in 4CMenB group as compared to the control group at 1 month after receiving the 2nd rMenB+OMV NZ vaccination||1.737|0.809|0.3828
74074292|NCT01214850|147701404|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.555|1.273|||Regression, Logistic|||Vaccine Group Odds Ratios for carriage of combined N. meningitidis serogroups A, C, W, Y in the MenACWY-CRM group compared to Control group at 1 month after receiving 1 injection of MenACWY vaccine||1.273|0.555|
74074293|NCT00565448|147701440|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0||||The Fisher's exact test was used to compare the CR proportions.|Fisher Exact|||There was no formal power calculation. A selection design was used to determine how many participants would be accrued to correctly select the treatment group with the best CR rate with 80% probability.||||1.0000
74074294|NCT00854308|147701449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.086||||0.6873|TWO_SIDED|95.0|0.727|1.622|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, Eastern Cooperative Oncology Group (ECOG) performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.||1.622|0.727|0.6873
74074295|NCT00854308|147701450|SUPERIORITY_OR_OTHER|||||||0.7101||95.0||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib.||||0.7101
74074296|NCT00854308|147701451|SUPERIORITY_OR_OTHER|||||||0.3671||95.0||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib||||0.3671
74074297|NCT00854308|147701452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.529||||0.0418|TWO_SIDED|95.0|0.284|0.986|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, ECOG performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.||0.986|0.284|0.0418
74074298|NCT00302952|147701470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79||||||Adjustments were made for baseline ln(CRP), baseline DAS28-CRP score, race, methotrexate use, anti-TNF use, and disease duration.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group. Log transformed CRP was analyzed to meet the heterogeneity assumption for ANCOVA models.||||0.79
74074299|NCT00302952|147701472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||Adjustments were made for baseline DAS28-CRP score.|ANCOVA|ANOVA was performed on participants with a DAS28-CRP score at Day 84.||The p-value compares Lovastatin with the Placebo treatment group.||||0.91
74074300|NCT00302952|147701473|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-11.0||||0.39|TWO_SIDED|95.0|-35.9|14.0|||Chi-squared||The difference in percentages is calculated as Lovastatin - Placebo.|The p-value compares Lovastatin with the Placebo treatment group.||14.0|-35.9|0.39
74074301|NCT00302952|147701474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||Adjustments were made for baseline serum IgM RF by ELISA test result. In the ANCOVA model, baseline value was a covariate; therefore, an adjustment was performed.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.||||0.19
74074302|NCT00302952|147701475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||Adjustments were made for baseline serum anti-CCP by ELISA|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.||||0.35
74074303|NCT03252353|147701495|SUPERIORITY|||||||0.0079|||||||Regression, Logistic|The adjusted proportion of responders is 58.16 for Octreotide Capsule Treatment Group vs. 19.42 for the Placebo||The proportion of \[IGF-1/GH\] responders was compared between treatment groups using an exact logistic regression model with categorical covariates for treatment group, prior SRL dose, and baseline \[IGF-1/GH\] level||||0.0079
74074304|NCT03252353|147701496|SUPERIORITY|||||||0.0007|||||||Regression, Logistic|The adjusted proportion of responders is 77.66 for Octreotide Capsule Treatment Group vs. 30.40 for the Placebo||The proportion of \[IGF-1/GH\] responders was compared between treatment groups using an exact logistic regression model with categorical covariates for treatment group, prior SRL dose, and baseline \[IGF-1/GH\] level||||0.0007
74074305|NCT03252353|147701497|SUPERIORITY|||||||0.0029|||||||Fisher Exact|||||||0.0029
74074306|NCT02008565|147701498|SUPERIORITY|||||||0.092||||||significance assessed at type 1 error alpha=0.05|Mixed Models Analysis|The models were adjusted for baseline Irritable Bowel Syndrome (IBS) status and clinical site.||||||0.092
74074307|NCT03435081|147701520|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|2.31|9.15|||Regression, Logistic|||||9.15|2.31|<0.001
74074308|NCT03435081|147701521|SUPERIORITY||Odds Ratio (OR)|2.51||||0.033|TWO_SIDED|95.0|1.08|5.83|||Regression, Logistic|||||5.83|1.08|0.033
74074309|NCT03435081|147701521|SUPERIORITY||Odds Ratio (OR)|5.29|||<|0.001|TWO_SIDED|95.0|2.4|11.68|||Regression, Logistic|||||11.68|2.40|<0.001
74074310|NCT03435081|147701522|SUPERIORITY||Odds Ratio (OR)|1.71||||0.167|TWO_SIDED|95.0|0.8|3.63|||Regression, Logistic|||||3.63|0.80|0.167
74074311|NCT03435081|147701523|SUPERIORITY||Odds Ratio (OR)|2.23||||0.131|TWO_SIDED|95.0|0.79|6.31|||Regression, Logistic|||||6.31|0.79|0.131
74074312|NCT03435081|147701523|SUPERIORITY||Odds Ratio (OR)|6.73|||<|0.001|TWO_SIDED|95.0|2.63|17.19|||Regression, Logistic|||||17.19|2.63|<0.001
74074313|NCT03435081|147701524|SUPERIORITY||Mean Difference (Final Values)|-12.59|STANDARD_ERROR_OF_MEAN|7.079||0.077|TWO_SIDED|95.0|-26.54|1.36|||Mixed Models Analysis|||||1.36|-26.54|0.077
73884443|NCT02135861|147302511|OTHER||Mean Difference (Final Values)|-0.0137||||0.7381|TWO_SIDED|95.0|-0.0968|0.0695||estimates of total lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0695|-0.0968|0.7381
73884444|NCT02135861|147302511|OTHER||Mean Difference (Final Values)|0.0136||||0.6992|TWO_SIDED|95.0|-0.058|0.0852||estimates of left lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0852|-0.0580|0.6992
73884445|NCT02135861|147302511|OTHER||Mean Difference (Final Values)|-0.0258||||0.5778|TWO_SIDED|95.0|-0.1201|0.0684||estimates of right lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0684|-0.1201|0.5778
73884446|NCT02135861|147302511|OTHER||Mean Difference (Final Values)|0.0005||||0.9899|TWO_SIDED|95.0|-0.0738|0.0747||estimates of left lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0747|-0.0738|0.9899
73884447|NCT02135861|147302511|OTHER||Mean Difference (Final Values)|0.0396||||0.2912|TWO_SIDED|95.0|-0.036|0.1153||estimates of left lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.1153|-0.0360|0.2912
73884448|NCT02135861|147302511|OTHER||Mean Difference (Final Values)|-0.0362||||0.4592|TWO_SIDED|95.0|-0.1355|0.0631||estimates of right lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0631|-0.1355|0.4592
73884449|NCT02135861|147302511|OTHER||Mean Difference (Final Values)|-0.0118||||0.7936|TWO_SIDED|95.0|-0.1036|0.08||estimates of right lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0800|-0.1036|0.7936
73884450|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.1148||||0.0156|TWO_SIDED|95.0|0.0236|0.2061||estimates of total lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2061|0.0236|0.0156
73884451|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.1366||||0.0026|TWO_SIDED|95.0|0.0523|0.2209||estimates of left lung- Pre-exercise|ANOVA|estimates of left lung- Pre-exercise|||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2209|0.0523|0.0026
73884452|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.1067||||0.0328|TWO_SIDED|95.0|0.0094|0.204||estimates of right lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2040|0.0094|0.0328
73884453|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.1145||||0.0158|TWO_SIDED|95.0|0.0235|0.2056||estimates of left lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2056|0.0235|0.0158
73884454|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.1776||||0.0002|TWO_SIDED|95.0|0.0917|0.2635||estimates of left lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2635|0.0917|0.0002
73884455|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.0956||||0.0658|TWO_SIDED|95.0|-0.0067|0.1979||estimates of right lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.1979|-0.0067|0.0658
73884456|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.1194||||0.015|TWO_SIDED|95.0|0.0251|0.2137||estimates of right lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2137|0.0251|0.0150
73884457|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.1428||||0.0015|TWO_SIDED|95.0|0.0598|0.2259||estimates of total lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2259|0.0598|0.0015
73884458|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.1776|||<|0.0001|TWO_SIDED|95.0|0.1057|0.2496||estimates of left lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2496|0.1057|<.0001
73884459|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.126||||0.0114|TWO_SIDED|95.0|0.0308|0.2212||estimates of right lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2212|0.0308|0.0114
74074314|NCT03435081|147701524|SUPERIORITY||Mean Difference (Final Values)|-20.3|STANDARD_ERROR_OF_MEAN|6.875||0.004|TWO_SIDED|95.0|-33.85|-6.75|||Mixed Models Analysis|||||-6.75|-33.85|0.004
74074315|NCT03435081|147701525|SUPERIORITY||Odds Ratio (OR)|1.24||||0.733|TWO_SIDED|95.0|0.36|4.36|||Regression, Logistic|||||4.36|0.36|0.733
74074316|NCT03435081|147701525|SUPERIORITY||Odds Ratio (OR)|5.42||||0.002|TWO_SIDED|95.0|1.93|15.22|||Regression, Logistic|||||15.22|1.93|0.002
74074317|NCT03435081|147701526|SUPERIORITY||Odds Ratio (OR)|3.08||||0.012|TWO_SIDED|95.0|1.29|7.36|||Regression, Logistic|||||7.36|1.29|0.012
73884460|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.1464||||0.0002|TWO_SIDED|95.0|0.0774|0.2153||estimates of left lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2153|0.0774|0.0002
73884461|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.2137|||<|0.0001|TWO_SIDED|95.0|0.1266|0.3008||estimates of left lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.3008|0.1266|<.0001
73884462|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.1111||||0.025|TWO_SIDED|95.0|0.0151|0.2071||estimates of right lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2071|0.0151|0.0250
73884463|NCT02135861|147302512|OTHER||Mean Difference (Final Values)|0.1458||||0.0052||95.0|0.0475|0.2442||estimates of right lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2442|0.0475|0.0052
73884464|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0524||||0.173|TWO_SIDED|95.0|-0.1292|0.0244||estimates of total lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0244|-0.1292|0.1730
73884465|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0423||||0.2704|TWO_SIDED|95.0|-0.1196|0.0349||estimates of left lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0349|-0.1196|0.2704
74074318|NCT03435081|147701526|SUPERIORITY||Odds Ratio (OR)|5.32|||<|0.001|TWO_SIDED|95.0|2.31|12.28|||Regression, Logistic|||||12.28|2.31|<0.001
73884466|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0515||||0.2072|TWO_SIDED|95.0|-0.1334|0.0303||estimates of right lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0303|-0.1334|0.2072
73884467|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0603||||0.1307|TWO_SIDED|95.0|-0.1398|0.0191||estimates of left lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0191|-0.1398|0.1307
73884468|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0078||||0.8427|TWO_SIDED|95.0|-0.0879|0.0722||estimates of left lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0722|-0.0879|0.8427
73884469|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0506||||0.1848|TWO_SIDED|95.0|-0.1269|0.0257||estimates of right lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0257|-0.1269|0.1848
73884470|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0413||||0.3408|TWO_SIDED|95.0|-0.1286|0.0461||estimates of right lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0461|-0.1286|0.3408
73884471|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0267||||0.3682|TWO_SIDED|95.0|-0.0866|0.0332||estimates of total lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0332|-0.0866|0.3682
73884472|NCT02135861|147302513|OTHER||Mean Difference (Net)|-0.0201||||0.4531|TWO_SIDED|95.0|-0.0744|0.0342||estimates of left lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0342|-0.0744|0.4531
73884473|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0188||||0.597|TWO_SIDED|95.0|-0.0909|0.0533||estimates of right lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0533|-0.0909|0.5970
73884474|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0159||||0.5472|TWO_SIDED|95.0|-0.0693|0.0375||estimates of left lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0375|-0.0693|0.5472
74074319|NCT03435081|147701527|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.273||0.433|TWO_SIDED|95.0|-0.75|0.32|||Mixed Models Analysis|||||0.32|-0.75|0.433
74074320|NCT03435081|147701527|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.269||0.029|TWO_SIDED|95.0|-1.12|-0.06|||Mixed Models Analysis|||||-0.06|-1.12|0.029
74074321|NCT03435081|147701528|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.441||0.012|TWO_SIDED|95.0|-1.99|-0.25|||Mixed Models Analysis|||||-0.25|-1.99|0.012
74074322|NCT03435081|147701528|SUPERIORITY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.433||0.002|TWO_SIDED|95.0|-2.22|-0.51|||Mixed Models Analysis|||||-0.51|-2.22|0.002
74074323|NCT03435081|147701529|SUPERIORITY||Odds Ratio (OR)|1.69||||0.105|TWO_SIDED|95.0|0.9|3.2|||Regression, Logistic|||||3.20|0.90|0.105
73884475|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0125||||0.6793|TWO_SIDED|95.0|-0.0742|0.0491||estimates of left lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0491|-0.0742|0.6793
73884476|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0249||||0.4806|TWO_SIDED|95.0|-0.0964|0.0466||estimates of right lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0466|-0.0964|0.4806
73884477|NCT02135861|147302513|OTHER||Mean Difference (Final Values)|-0.0029||||0.9379|TWO_SIDED|95.0|-0.0789|0.0731||estimates of right lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0731|-0.0789|0.9379
73884478|NCT02587221|147302521|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|19.8|||||TWO_SIDED|97.45|-5.27|38.91|||Regression, Cox|Adjusted for covariates||The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%||38.91|-5.27|
73884479|NCT02587221|147302526|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as the presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|32.12|||||TWO_SIDED|95.0|10.23|48.67|||Regression, Cox|Adjusted for covariates||||48.67|10.23|
73884480|NCT02587221|147302527|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the vaccine strains.~An ILI was defined as the presence of ≥1 respiratory symptom (eg. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|49.94|||||TWO_SIDED|95.0|-24.03|79.79|||Regression, Cox|Adjusted for covariates||The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%||79.79|-24.03|
73884481|NCT02587221|147302528|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|61.5|||||TWO_SIDED|95.0|-7.98|86.28|||Regression, Cox|Adjusted for covariates||||86.28|-7.98|
74074324|NCT03435081|147701529|SUPERIORITY||Odds Ratio (OR)|3.67|||<|0.001|TWO_SIDED|95.0|2.02|6.68|||Regression, Logistic|||||6.68|2.02|<0.001
74074325|NCT03435081|147701530|SUPERIORITY||Odds Ratio (OR)|3.81||||0.144|TWO_SIDED|95.0|0.63|22.85|||Regression, Logistic|||||22.85|0.63|0.144
73884482|NCT02587221|147302529|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any vaccine strain regardless of antigenic match.~An ILI was defined as the presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|28.66|||||TWO_SIDED|95.0|0.05|49.08|||Regression, Cox|Adjusted for covariates||||49.08|0.05|
73884483|NCT02587221|147302530|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|33.47|||||TWO_SIDED|95.0|2.56|54.57|||Regression, Cox|Adjusted for covariates||||54.57|2.56|
74074326|NCT03435081|147701530|SUPERIORITY||Odds Ratio (OR)|3.1||||0.227|TWO_SIDED|95.0|0.5|19.4|||Regression, Logistic|||||19.40|0.50|0.227
74074327|NCT03435081|147701531|SUPERIORITY||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|3.921||0.316|TWO_SIDED|95.0|-11.67|3.79|||Mixed Models Analysis|||||3.79|-11.67|0.316
74074328|NCT03435081|147701531|SUPERIORITY||Mean Difference (Final Values)|-11.81|STANDARD_ERROR_OF_MEAN|3.758||0.002|TWO_SIDED|95.0|-19.23|-4.4|||Mixed Models Analysis|||||-4.40|-19.23|0.002
74074329|NCT03435081|147701532|SUPERIORITY||Odds Ratio (OR)|1.39||||0.683|TWO_SIDED|95.0|0.29|6.78|||Regression, Logistic|||||6.78|0.29|0.683
74074330|NCT03435081|147701532|SUPERIORITY||Odds Ratio (OR)|2.25||||0.277|TWO_SIDED|95.0|0.52|9.68|||Regression, Logistic|||||9.68|0.52|0.277
74074331|NCT03435081|147701533|SUPERIORITY||Mean Difference (Final Values)|-6.02|STANDARD_ERROR_OF_MEAN|2.996||0.046|TWO_SIDED|95.0|-11.93|-0.12|||Mixed Models Analysis|||||-0.12|-11.93|0.046
74074332|NCT03435081|147701533|SUPERIORITY||Mean Difference (Final Values)|-7.72|STANDARD_ERROR_OF_MEAN|2.911||0.009|TWO_SIDED|95.0|-13.46|-1.98|||Mixed Models Analysis|||||-1.98|-13.46|0.009
74074333|NCT03435081|147701534|SUPERIORITY|||||||0.598|||||||Fisher Exact|||||||0.598
74074334|NCT03435081|147701534|SUPERIORITY|||||||0.785|||||||Fisher Exact|||||||0.785
74074335|NCT03435081|147701535|SUPERIORITY||Mean Difference (Final Values)|-12.27|STANDARD_ERROR_OF_MEAN|6.562||0.063|TWO_SIDED|95.0|-25.21|0.66|||Mixed Models Analysis|||||0.66|-25.21|0.063
74074336|NCT03435081|147701535|SUPERIORITY||Mean Difference (Final Values)|-21.85|STANDARD_ERROR_OF_MEAN|6.437|<|0.001|TWO_SIDED|95.0|-34.54|-9.17|||Mixed Models Analysis|||||-9.17|-34.54|<0.001
74074337|NCT03435081|147701536|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.536||0.217|TWO_SIDED|95.0|-4.93|1.12|||Mixed Models Analysis|||||1.12|-4.93|0.217
74074338|NCT03435081|147701536|SUPERIORITY||Mean Difference (Final Values)|-4.77|STANDARD_ERROR_OF_MEAN|1.487||0.002|TWO_SIDED|95.0|-7.7|-1.84|||Mixed Models Analysis|||||-1.84|-7.70|0.002
74074339|NCT03435081|147701537|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.178||0.155|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||||0.10|-0.60|0.155
74074340|NCT03435081|147701537|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.174||0.017|TWO_SIDED|95.0|-0.76|-0.07|||Mixed Models Analysis|||||-0.07|-0.76|0.017
74074341|NCT03435081|147701538|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.565||0.345|TWO_SIDED|95.0|-0.58|1.65|||Mixed Models Analysis|||Anxiety||1.65|-0.58|0.345
74074342|NCT03435081|147701538|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.543||0.336|TWO_SIDED|95.0|-1.59|0.55|||Mixed Models Analysis|||Anxiety||0.55|-1.59|0.336
74074343|NCT03435081|147701538|SUPERIORITY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.465||0.353|TWO_SIDED|95.0|-0.48|1.35|||Mixed Models Analysis|||Depression||1.35|-0.48|0.353
74074344|NCT03435081|147701538|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.446||0.34|TWO_SIDED|95.0|-1.31|0.45|||Mixed Models Analysis|||Depression||0.45|-1.31|0.340
74074345|NCT03435081|147701539|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.228||0.224|TWO_SIDED|95.0|-3.92|0.92|||Mixed Models Analysis|||||0.92|-3.92|0.224
74074346|NCT03435081|147701539|SUPERIORITY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.184||0.004|TWO_SIDED|95.0|-5.83|-1.16|||Mixed Models Analysis|||||-1.16|-5.83|0.004
74074347|NCT03435081|147701540|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|5.956||0.575|TWO_SIDED|95.0|-15.3|8.57|||Mixed Models Analysis|||Absenteeism Change from Baseline||8.57|-15.30|0.575
74074348|NCT03435081|147701540|SUPERIORITY||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|5.664||0.851|TWO_SIDED|95.0|-12.43|10.3|||Mixed Models Analysis|||Absenteeism Change from Baseline||10.30|-12.43|0.851
74074349|NCT03435081|147701540|SUPERIORITY||Mean Difference (Final Values)|-11.75|STANDARD_ERROR_OF_MEAN|5.212||0.026|TWO_SIDED|95.0|-22.05|-1.45|||Mixed Models Analysis|||Presenteeism Change from Baseline||-1.45|-22.05|0.026
74074350|NCT03435081|147701540|SUPERIORITY||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|5.056||0.002|TWO_SIDED|95.0|-25.89|-5.91|||Mixed Models Analysis|||Presenteeism Change from Baseline||-5.91|-25.89|0.002
74074351|NCT03435081|147701540|SUPERIORITY||Mean Difference (Final Values)|-12.85|STANDARD_ERROR_OF_MEAN|6.237||0.041|TWO_SIDED|95.0|-25.18|-0.51|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-0.51|-25.18|0.041
74074352|NCT03435081|147701540|SUPERIORITY||Mean Difference (Final Values)|-16.27|STANDARD_ERROR_OF_MEAN|6.034||0.008|TWO_SIDED|95.0|-28.2|-4.34|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-4.34|-28.20|0.008
74074353|NCT03435081|147701540|SUPERIORITY||Mean Difference (Final Values)|-9.64|STANDARD_ERROR_OF_MEAN|4.219||0.023|TWO_SIDED|95.0|-17.95|-1.32|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-1.32|-17.95|0.023
74074354|NCT03435081|147701540|SUPERIORITY||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|4.115||0.001|TWO_SIDED|95.0|-21.4|-5.17|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-5.17|-21.40|0.001
74074355|NCT03435081|147701541|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.026||0.482|TWO_SIDED|95.0|-0.03|0.07|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.07|-0.03|0.482
74074356|NCT03435081|147701541|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.026||0.043|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.10|0.00|0.043
74074357|NCT03435081|147701541|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.037||0.656|TWO_SIDED|95.0|-0.06|0.09|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.09|-0.06|0.656
74074358|NCT03435081|147701541|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.036||0.057|TWO_SIDED|95.0|0.0|0.14|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.14|-0.00|0.057
74074359|NCT03435081|147701542|SUPERIORITY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|2.597||0.609|TWO_SIDED|95.0|-6.45|3.79|||Mixed Models Analysis|||||3.79|-6.45|0.609
74074360|NCT03435081|147701542|SUPERIORITY||Mean Difference (Final Values)|3.48|STANDARD_ERROR_OF_MEAN|2.503||0.166|TWO_SIDED|95.0|-1.46|8.41|||Mixed Models Analysis|||||8.41|-1.46|0.166
74074361|NCT03435081|147701543|SUPERIORITY||Odds Ratio (OR)|1.96||||0.258|TWO_SIDED|95.0|0.61|6.26|||Regression, Logistic|||||6.26|0.61|0.258
74074362|NCT03435081|147701543|SUPERIORITY||Odds Ratio (OR)|2.99||||0.052|TWO_SIDED|95.0|0.99|8.97|||Regression, Logistic|||||8.97|0.99|0.052
74074363|NCT00420238|147701544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83||||0.019|TWO_SIDED|95.0|-16.5|-1.51|||ANCOVA||Least squares mean difference = mean difference final value.|Comparison of least squares means. Primary analysis: analysis of covariance (ANCOVA) with treatment as a factor and BASDAI baseline as a covariate.||-1.51|-16.5|0.019
74074364|NCT00420238|147701545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.098|TWO_SIDED|95.0|0.82|10.42|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||10.42|0.82|0.098
74074365|NCT00420238|147701545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.197|TWO_SIDED|95.0|0.69|5.88|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||5.88|0.69|0.197
74074366|NCT00420238|147701545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.087|TWO_SIDED|95.0|0.89|5.95|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||5.95|0.89|0.087
73884484|NCT02587221|147302531|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the vaccine strains.~An ILI is the presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|23.79|||||TWO_SIDED|95.0|-9.69|47.05|||Regression, Cox|Adjusted for covariates||||47.05|-9.69|
74074367|NCT00420238|147701545|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.83||||0.031|TWO_SIDED|95.0|1.1|7.29|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||7.29|1.10|0.031
73884485|NCT02587221|147302532|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|26.11|||||TWO_SIDED|95.0|-11.71|51.13|||Regression, Cox|Adjusted for covariates||||51.13|-11.71|
74074368|NCT00420238|147701546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.31|TWO_SIDED|95.0|0.62|4.57|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||4.57|0.62|0.310
74074369|NCT00420238|147701546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.309|TWO_SIDED|95.0|0.65|3.99|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||3.99|0.65|0.309
74074370|NCT00420238|147701546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.61||||0.001|TWO_SIDED|95.0|1.81|11.74|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.74|1.81|0.001
73884486|NCT02587221|147302537|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|51.08|||||TWO_SIDED|95.0|28.21|66.67|||Regression, Cox|Adjusted for covariates||||66.67|28.21|
74074371|NCT00420238|147701546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14||||0.003||95.0|1.65|10.42|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||10.42|1.65|0.003
73884487|NCT02587221|147302538|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)"|Vaccine efficacy (VE)|74.96|||||TWO_SIDED|95.0|-17.93|94.68|||Regression, Cox|Adjusted for covariates||||94.68|-17.93|
74074372|NCT00420238|147701548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.259|TWO_SIDED|95.0|0.57|7.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||7.94|0.57|0.259
74074373|NCT00420238|147701548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.44||95.0|0.51|4.64|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||4.64|0.51|0.440
74074374|NCT00420238|147701548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.046||95.0|1.02|8.16|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||8.16|1.02|0.046
74074375|NCT00420238|147701548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85||||0.014||95.0|1.31|11.32|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.32|1.31|0.014
74074376|NCT00420238|147701550|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.204|TWO_SIDED|95.0|0.55|16.53|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||16.53|0.55|0.204
74074377|NCT00420238|147701550|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
74074378|NCT00420238|147701550|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.73||||0.121||95.0|0.71|19.69|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||19.69|0.71|0.121
74074379|NCT00420238|147701550|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36||||0.058||95.0|0.96|11.8|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.80|0.96|0.058
74074380|NCT00420238|147701552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5||||0.287|TWO_SIDED|95.0|0.35|35.14|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||35.14|0.35|0.287
74074381|NCT00420238|147701552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8||||0.169||95.0|0.51|44.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||44.94|0.51|0.169
74074382|NCT00420238|147701552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
74074383|NCT00420238|147701552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
74074384|NCT00420238|147701554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.95||||0.018|TWO_SIDED|95.0|-18.19|-1.72|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-1.72|-18.19|0.018
73884488|NCT02587221|147302539|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|60.17|||||TWO_SIDED|95.0|31.19|76.94|||Regression, Cox|Adjusted for covariates||||76.94|31.19|
74074385|NCT00420238|147701555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.54||||0.089|TWO_SIDED|95.0|-18.4|1.33|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||1.33|-18.40|0.089
74074386|NCT00420238|147701555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.02||||0.11||95.0|-17.89|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||1.85|-17.89|0.110
74074387|NCT00420238|147701555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73||||0.004||95.0|-24.6|-4.86|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||-4.86|-24.60|0.004
74074388|NCT00420238|147701555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.27||||0.065||95.0|-19.14|0.59|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||0.59|-19.14|0.065
74074389|NCT00420238|147701557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.99||||0.002|TWO_SIDED|95.0|-17.7|-4.28|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-4.28|-17.70|0.002
74074390|NCT00420238|147701558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33||||0.054|TWO_SIDED|95.0|-16.81|0.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||0.15|-16.81|0.054
74074391|NCT00420238|147701558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02||||0.011||95.0|-19.5|-2.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-2.54|-19.50|0.011
74074392|NCT00420238|147701558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.75||||0.003||95.0|-21.23|-4.27|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-4.27|-21.23|0.003
74074393|NCT00420238|147701558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.29|||<|0.001||95.0|-23.7|-6.82|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-6.82|-23.7|<0.001
74074394|NCT00420238|147701560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.59||||0.039|TWO_SIDED|95.0|-18.69|-0.49|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-0.49|-18.69|0.039
74074395|NCT00420238|147701561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.28||||0.254|TWO_SIDED|95.0|-17.13|4.57|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||4.57|-17.13|0.254
74074396|NCT00420238|147701561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17||||0.348||95.0|-16.02|5.68|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||5.68|-16.02|0.348
74074397|NCT00420238|147701561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.72||||0.014||95.0|-24.57|-2.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-2.88|-24.57|0.014
74074398|NCT00420238|147701561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.69|||<|0.001||95.0|-30.54|-8.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-8.84|-30.54|<0.001
73884489|NCT02587221|147302540|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|57.02|||||TWO_SIDED|95.0|22.73|76.09|||Regression, Cox|Adjusted for covariates||||76.09|22.73|
73884490|NCT02242942|147302544|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.22|0.51|||Log Rank||Hazard ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.|||0.51|0.22|<0.0001
73884491|NCT02242942|147302545|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.23|0.53|||Log Rank||Hazard Ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.|||0.53|0.23|<0.0001
73884492|NCT02242942|147302546|SUPERIORITY||Difference in Response Rates|13.43||||0.0007|TWO_SIDED|95.0|5.47|21.38||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.|||21.38|5.47|0.0007
73884493|NCT02242942|147302547|SUPERIORITY||Difference in Response Rates|26.39|||<|0.0001|TWO_SIDED|95.0|17.41|35.36||P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||35.36|17.41|<0.0001
73884494|NCT02242942|147302548|SUPERIORITY||Difference in MRD Negative Rates|40.28|||<|0.0001|TWO_SIDED|95.0|31.45|49.1|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||49.10|31.45|<0.0001
73884495|NCT02242942|147302549|SUPERIORITY||Difference in MRD Negative Rates|39.81|||<|0.0001|TWO_SIDED|95.0|31.27|48.36|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||48.36|31.27|<0.0001
73884496|NCT02242942|147302551|SUPERIORITY||Difference in MRD Negative Rates|32.87|||<|0.0001|TWO_SIDED|95.0|23.76|41.98|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.|||41.98|23.76|<0.0001
73884497|NCT02242942|147302552|SUPERIORITY||Difference in MRD Negative Rates|38.43|||<|0.0001|TWO_SIDED|95.0|30.15|46.71|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.|||46.71|30.15|<0.0001
73884498|NCT02242942|147302553|SUPERIORITY||Difference in Response Rates|1.85||||0.5612|TWO_SIDED|95.0|-4.63|8.33||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.|||8.33|-4.63|0.5612
73884499|NCT02242942|147302555|SUPERIORITY||Difference in Response Rates|0.93||||0.7169|TWO_SIDED|95.0|-4.66|6.51|||Cochran-Mantel-Haenszel|P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|95% CI for difference in rates were constructed using Anderson-Hauck method.|||6.51|-4.66|0.7169
73884500|NCT00214045|147302568|SUPERIORITY_OR_OTHER|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
74074399|NCT00420238|147701563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49||||0.071|TWO_SIDED|95.0|-17.73|0.75|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.75|-17.73|0.071
73884501|NCT00214045|147302568|NON_INFERIORITY_OR_EQUIVALENCE|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.37
73884502|NCT01451606|147302572|SUPERIORITY|||||||0.52||||||Note that sample size was well below our target, making this test very low power.|Wilcoxon (Mann-Whitney)|||||||0.52
73884503|NCT01451606|147302573|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
73884504|NCT02163538|147302576|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
73884505|NCT02163538|147302577|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
73884506|NCT02163538|147302578|SUPERIORITY|||||||0.582|||||||Chi-squared|||||||0.582
73884507|NCT02163538|147302579|SUPERIORITY|||||||0.0031|||||||Chi-squared|||||||0.0031
73884508|NCT02163538|147302580|SUPERIORITY|||||||0.0281|||||||Wilcoxon (Mann-Whitney)|||||||0.0281
73884509|NCT02163538|147302581|SUPERIORITY|||||||0.0821|||||||Wilcoxon (Mann-Whitney)|||||||.0821
73884510|NCT01283139|147302582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.057|TWO_SIDED|90.0|1.03|2.71|||Regression, Logistic|||||2.71|1.03|0.057
74074400|NCT00420238|147701564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57||||0.511|TWO_SIDED|95.0|-14.31|7.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||7.17|-14.31|0.511
73884511|NCT01283139|147302582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.094|TWO_SIDED|90.0|1.01|2.54|||Regression, Logistic|||||2.54|1.01|0.094
74074401|NCT00420238|147701564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.57||||0.401||95.0|-15.31|6.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||6.17|-15.31|0.401
73884512|NCT01283139|147302582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.031|TWO_SIDED|90.0|1.16|2.94|||Regression, Logistic|||||2.94|1.16|0.031
74074402|NCT00420238|147701564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.45||||0.023||95.0|-23.19|-1.71|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-1.71|-23.19|0.023
74074403|NCT00420238|147701564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.25||||0.01||95.0|-24.99|-3.51|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.51|-24.99|0.010
74074404|NCT00420238|147701566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.25||||0.127|TWO_SIDED|95.0|-12.03|1.53|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline as a covariate.||1.53|-12.03|0.127
73884513|NCT01283139|147302583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.042|TWO_SIDED|90.0|1.13|3.14|||Regression, Logistic|||||3.14|1.13|0.042
73884514|NCT01283139|147302583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.264|TWO_SIDED|90.0|0.85|2.35|||Regression, Logistic|||||2.35|0.85|0.264
73884515|NCT01283139|147302583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.038|TWO_SIDED|90.0|1.14|3.19|||Regression, Logistic|||||3.19|1.14|0.038
73884516|NCT01283139|147302584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.808|TWO_SIDED|90.0|0.37|3.81|||Regression, Logistic|||||3.81|0.37|0.808
73884517|NCT01283139|147302584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.598|TWO_SIDED|90.0|0.45|4.66|||Regression, Logistic|||||4.66|0.45|0.598
73884518|NCT01283139|147302584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.884|TWO_SIDED|90.0|0.27|3.02|||Regression, Logistic|||||3.02|0.27|0.884
73884519|NCT01283139|147302585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.044|TWO_SIDED|90.0|1.22|7.01|||Regression, Logistic|||||7.01|1.22|0.044
73884520|NCT01283139|147302585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.498|TWO_SIDED|90.0|0.62|3.19|||Regression, Logistic|||||3.19|0.62|0.498
73884521|NCT01283139|147302585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03||||0.049|TWO_SIDED|90.0|1.2|7.68|||Regression, Logistic|||||7.68|1.20|0.049
73884522|NCT01283139|147302586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.27|TWO_SIDED|90.0|0.85|2.25|||Regression, Logistic|||||2.25|0.85|0.270
73884523|NCT01283139|147302586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||0.077|TWO_SIDED|90.0|1.04|2.74|||Regression, Logistic|||||2.74|1.04|0.077
73884524|NCT01283139|147302586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.453|TWO_SIDED|90.0|0.76|2.05|||Regression, Logistic|||||2.05|0.76|0.453
73884525|NCT02234843|147302689|OTHER||Hazard Ratio (HR)|0.4||||0.1509|TWO_SIDED|95.0|0.11|1.41|||Expl. Cox Proportional Hazards Model|||||1.41|0.11|0.1509
73884526|NCT02787564|147302724|OTHER||||||<|0.001||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||<0.001
73884527|NCT02787564|147302725|OTHER|||||||0.038||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.038
73884528|NCT02787564|147302726|OTHER|||||||0.026||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.026
73884529|NCT02787564|147302727|OTHER|||||||0.443||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.443
73884530|NCT02787564|147302728|OTHER|||||||0.006||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.006
73884531|NCT02787564|147302729|OTHER|||||||0.029||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.029
73884532|NCT01607957|147302730|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.58|0.81|||Stratified log-rank test|||||0.81|0.58|<0.0001
73884533|NCT01607957|147302731|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.0001|TWO_SIDED|95.0|0.41|0.57|||Stratified log-rank test|||||0.57|0.41|<0.0001
73884534|NCT03919773|147302740|SUPERIORITY|||||||0.629|||||||Kruskal-Wallis|||Intention-to-treat analysis||||0.629
73884535|NCT03919773|147302741|SUPERIORITY|||||||0.718|||||||Fisher Exact|||comparison of proportion with positive treatment response (as defined) in IVIG group compared to albumin||||0.718
73884536|NCT04966013|147302752|SUPERIORITY||Hazard Ratio (HR)|1.005||||0.9784|TWO_SIDED|95.0|0.717|1.408|||Regression, Cox|||Log Rank Test and Cox PH Regression analyses were performed unstratified||1.408|0.717|0.9784
73884537|NCT04966013|147302753|SUPERIORITY||Hazard Ratio (HR)|1.388||||0.1512|TWO_SIDED|95.0|0.887|2.172||Log Rank Test and Cox PH Regression analyses were performed unstratified|Regression, Cox|||||2.172|0.887|0.1512
73884538|NCT03518086|147302764|SUPERIORITY||Risk Difference (RD)|11.1||||6e-05|TWO_SIDED|99.875|3.2|19.1|||Cochran-Mantel-Haenszel|||||19.1|3.2|0.00006
73884539|NCT03518086|147302765|SUPERIORITY||Risk Difference (RD)|21.4|||<|1e-05|TWO_SIDED|99.875|10.8|32.0|||Cochran-Mantel-Haenszel|||||32.0|10.8|<0.00001
73884540|NCT03518086|147302766|SUPERIORITY||Risk Difference (RD)|15.4|||<|1e-05|TWO_SIDED|99.875|6.3|24.5|||Cochran-Mantel-Haenszel|||||24.5|6.3|<0.00001
73884541|NCT03518086|147302767|SUPERIORITY||Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|99.875|11.4|23.6|||Cochran-Mantel-Haenszel|||||23.6|11.4|<0.001
73884542|NCT03518086|147302768|SUPERIORITY||Risk Difference (RD)|20.2|||<|0.001|TWO_SIDED|95.0|13.8|26.6|||Cochran-Mantel-Haenszel|||||26.6|13.8|<0.001
73884543|NCT03518086|147302769|SUPERIORITY||Risk Difference (RD)|13.7|||<|0.001|TWO_SIDED|95.0|8.6|18.7|||Cochran-Mantel-Haenszel|||||18.7|8.6|<0.001
73884544|NCT03518086|147302770|SUPERIORITY||Risk Difference (RD)|19.5|||<|1e-05|TWO_SIDED|95.0|13.2|25.8|||Cochran-Mantel-Haenszel|||||25.8|13.2|<0.00001
73884545|NCT03518086|147302771|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.159|<|1e-05|TWO_SIDED|99.875|-1.47|-0.44|||Mixed Models Analysis||The confidence interval of 99.875 % was chosen to match the significance level.|||-0.44|-1.47|<0.00001
74074405|NCT00420238|147701567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.914|TWO_SIDED|95.0|-8.23|7.38|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||7.38|-8.23|0.914
74074406|NCT00420238|147701567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.544||95.0|-10.21|5.41|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||5.41|-10.21|0.544
74074407|NCT00420238|147701567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.21||||0.039||95.0|-16.02|-0.4|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-0.40|-16.02|0.039
74074408|NCT00420238|147701567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54||||0.004||95.0|-19.35|-3.73|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.73|-19.35|0.004
74074409|NCT00420238|147701570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.86||||0.122|TWO_SIDED|95.0|-15.57|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||1.85|-15.57|0.122
74074410|NCT00420238|147701570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.45||||0.145||95.0|-15.16|2.26|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||2.26|-15.16|0.145
74074411|NCT00420238|147701570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.55||||0.005||95.0|-21.26|-3.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.84|-21.26|0.005
74074412|NCT00420238|147701570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.95||||0.008||95.0|-20.66|-3.24|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.24|-20.66|0.008
74074413|NCT00420238|147701574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94||||0.139|TWO_SIDED|95.0|-13.84|1.96|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||1.96|-13.84|0.139
74074414|NCT00420238|147701575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.857|TWO_SIDED|95.0|-8.88|10.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||10.67|-8.88|0.857
74074415|NCT00420238|147701575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.304||95.0|-14.88|4.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||4.67|-14.88|0.304
74074416|NCT00420238|147701575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.047||95.0|-19.68|-0.13|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-0.13|-19.68|0.047
74074417|NCT00420238|147701575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.65||||0.007||95.0|-23.43|-3.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.88|-23.43|0.007
74074418|NCT00420238|147701578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.003|TWO_SIDED|95.0|0.06|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.31|0.06|0.003
74074419|NCT00420238|147701578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.006|TWO_SIDED|95.0|0.05|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.31|0.05|0.006
74074420|NCT00420238|147701578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.205|TWO_SIDED|95.0|-0.04|0.17|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Expitatory Volume in 1 second: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.17|-0.04|0.205
74074421|NCT00420238|147701579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.03|TWO_SIDED|95.0|-4.93|-0.26|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis oaf covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-0.26|-4.93|0.030
74074422|NCT00420238|147701580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.035|TWO_SIDED|95.0|-0.45|-0.02|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as covariate.||-0.02|-0.45|0.035
74074423|NCT00420238|147701581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.515|TWO_SIDED|95.0|-0.38|0.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.19|-0.38|0.515
74074424|NCT00420238|147701581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.316||95.0|-0.43|0.14|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.14|-0.43|0.316
74074425|NCT00420238|147701581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.008||95.0|-0.67|-0.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-0.10|-0.67|0.008
74074426|NCT00420238|147701581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.011||95.0|-0.65|-0.08|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-0.08|-0.65|0.011
74074427|NCT00420238|147701593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.613|TWO_SIDED|95.0|-0.22|0.37|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.37|-0.22|0.613
74074428|NCT00420238|147701594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.744|TWO_SIDED|95.0|-0.34|0.47|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.47|-0.34|0.744
74074429|NCT00420238|147701594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.625||95.0|-0.5|0.3|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.30|-0.50|0.625
74074430|NCT00420238|147701594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.325||95.0|-0.2|0.6|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.60|-0.20|0.325
74074431|NCT00420238|147701594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.76||95.0|-0.34|0.46|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.46|-0.34|0.760
74074432|NCT00420238|147701596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.72||||0.49|TWO_SIDED|95.0|-18.35|8.91|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||8.91|-18.35|0.490
74074433|NCT00420238|147701596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09||||0.651||95.0|-16.73|10.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||10.54|-16.73|0.651
74074434|NCT00420238|147701596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.84||95.0|-15.12|12.34|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||12.34|-15.12|0.840
74074435|NCT00420238|147701596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02||||0.562||95.0|-17.81|9.77|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||9.77|-17.81|0.562
74074436|NCT00420238|147701598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73|||<|0.0001|TWO_SIDED|95.0|-19.44|-10.03|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA)with treatment as a factor and baseline vlue as a covariate.||-10.03|-19.44|<0.0001
74074437|NCT00420238|147701599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.37|||<|0.0001|TWO_SIDED|95.0|-18.17|-6.58|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and atients as a random factor.||-6.58|-18.17|<0.0001
73884546|NCT03518086|147302772|SUPERIORITY||Mean Difference (Net)|13.21|STANDARD_ERROR_OF_MEAN|2.005|<|0.001|TWO_SIDED|95.0|9.28|17.15|||ANCOVA|||||17.15|9.28|<0.001
74074438|NCT00420238|147701599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.45|||<|0.0001||95.0|-23.25|-11.65|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-11.65|-23.25|<0.0001
74074439|NCT00420238|147701599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.95|||<|0.0001||95.0|-22.75|-11.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-11.15|-22.75|<0.0001
73884547|NCT03518086|147302773|SUPERIORITY||Mean Difference (Net)|-935.6|STANDARD_ERROR_OF_MEAN|218.09|<|0.001|TWO_SIDED|95.0|-1363.64|-507.55|||Mixed Models Analysis|||||-507.55|-1363.64|<0.001
74074440|NCT00420238|147701599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.0001||95.0|-23.96|-12.36|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-12.36|-23.96|<0.0001
74074441|NCT00420238|147701601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|||<|0.0001|TWO_SIDED|95.0|-18.23|-8.25|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA), with treatment as a factor and baseline value as a covariate.||-8.25|-18.23|<0.0001
74074442|NCT00420238|147701602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.32|||<|0.0001|TWO_SIDED|95.0|-20.55|-8.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.10|-20.55|<0.0001
74074443|NCT00420238|147701602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.98|||<|0.0001||95.0|-21.2|-8.76|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.76|-21.20|<0.0001
74074444|NCT00420238|147701602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.19|||<|0.0001||95.0|-21.41|-8.96|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.96|-21.41|<0.0001
74074445|NCT00420238|147701602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.41|||<|0.0001||95.0|-20.63|-8.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.19|-20.63|<0.0001
74074446|NCT00420238|147701605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.184|TWO_SIDED|95.0|0.74|4.7|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||4.70|0.74|0.184
74074447|NCT00420238|147701605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62||||0.036||95.0|1.06|6.46|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||6.46|1.06|0.036
74074448|NCT00420238|147701605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96||||0.001||95.0|1.89|13.03|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||13.03|1.89|0.001
74074449|NCT00420238|147701605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.065||95.0|0.95|5.96|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||5.96|0.95|0.065
74074450|NCT00420238|147701607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57||||0.004|TWO_SIDED|95.0|1.64|12.74|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||12.74|1.64|0.004
74074451|NCT00420238|147701607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46||||0.054||95.0|0.99|6.12|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||6.12|0.99|0.054
73884548|NCT02994108|147302792|SUPERIORITY||Chi-Square|0.415||||0.601|TWO_SIDED||||||Chi-squared|||||||.601
73884549|NCT02994108|147302793|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.249|TWO_SIDED||||||t-test, 2 sided|||||||.249
73884550|NCT02994108|147302794|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.675|TWO_SIDED||||||t-test, 2 sided|||||||.675
74074452|NCT00420238|147701607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.26|||<|0.001||95.0|2.27|17.31|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||17.31|2.27|<0.001
74074453|NCT00420238|147701607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.025||95.0|1.14|7.27|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||7.27|1.14|0.025
74074454|NCT03966365|147701635|OTHER|||||||0.706|||||||Wilcoxon (Mann-Whitney)|||||||0.706
74074455|NCT03966365|147701636|OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
73884551|NCT02994108|147302795|SUPERIORITY||Odds Ratio (OR)|3.43||||0.025|TWO_SIDED|95.0|1.17|10.08|||Regression, Logistic|||||10.08|1.17|.025
73884552|NCT02994108|147302796|SUPERIORITY||Odds Ratio (OR)|1.14||||0.923|TWO_SIDED|95.0|0.08|16.95|||Regression, Logistic|||||16.95|0.08|.923
73884553|NCT02994108|147302797|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.174|TWO_SIDED||||||t-test, 2 sided|||||||.174
73884554|NCT02994108|147302798|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||.002
73884555|NCT02994108|147302799|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.964|TWO_SIDED||||||t-test, 2 sided|||||||.964
73884556|NCT02994108|147302800|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||.053
73884557|NCT02994108|147302801|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.183|TWO_SIDED||||||t-test, 2 sided|||||||.183
73884558|NCT02994108|147302802|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.064|TWO_SIDED||||||t-test, 2 sided|||||||.064
73884559|NCT02994108|147302803|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.147|TWO_SIDED||||||t-test, 2 sided|||||||.147
73884560|NCT02994108|147302804|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.096|TWO_SIDED||||||t-test, 2 sided|||||||.096
73884561|NCT02994108|147302805|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.013|TWO_SIDED||||||t-test, 2 sided|||||||.013
73884562|NCT01097668|147302828|SUPERIORITY_OR_OTHER||||||<|0.001|||||||negative binomial model|||Comparison of the baseline 'ITT population' MRI data with week 16 data.||||<0.001
73884563|NCT01097668|147302828|SUPERIORITY_OR_OTHER|||||||0.03|||||||negative binomial model|||Comparison of the baseline 'MRI population' data with data from week 16.||||0.030
73884564|NCT04607668|147302843|OTHER||Mean Difference (Final Values)|-1.2|||<|0.001|TWO_SIDED|95.0|-1.7|-0.6||Two-sided p-value for treatment effect was generated from a nonparametric ANCOVA controlling for stratification factors of Region and Prior chemotherapy with study baseline ANC value as a covariate.|ANCOVA|||||-0.6|-1.7|<0.001
73884565|NCT04607668|147302844|OTHER||aRR|0.04|STANDARD_ERROR_OF_MEAN|0.032|<|0.001|TWO_SIDED|95.0|0.01|0.19|||modified Poisson model|||||0.19|0.01|<0.001
73884566|NCT01428258|147302865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-147.0|STANDARD_ERROR_OF_MEAN|39.0||0.0008|TWO_SIDED||||||ANCOVA|||||||0.0008
73884567|NCT01428258|147302865|OTHER|||||||0.136|||||||ANCOVA|||||||0.136
73884568|NCT01428258|147302865|OTHER|||||||0.044|||||||ANCOVA|||||||0.044
73884569|NCT01428258|147302866|OTHER|||||||0.576|||||||ANOVA|||||||0.576
73884570|NCT01428258|147302867|OTHER|||||||0.902|||||||t-test, 2 sided|||||||0.902
73884571|NCT01428258|147302868|OTHER|||||||0.797|||||||t-test, 2 sided|||||||0.797
73884572|NCT01428258|147302869|OTHER|||||||0.0001|||||||ANOVA|||||||0.0001
73884573|NCT02766023|147302873|SUPERIORITY||Risk Difference (RD)|0.04||||0.467|TWO_SIDED|95.0|-0.1|0.18|||Fisher Exact|||||0.18|-0.10|0.467
73884574|NCT02766023|147302874|SUPERIORITY||Odds Ratio (OR)|0.54||||0.031|TWO_SIDED|95.0|0.3|0.95|||Chi-squared|||||0.95|0.30|0.031
73884575|NCT02766023|147302875|SUPERIORITY||Risk Difference (RD)|0.03||||0.643|TWO_SIDED|95.0|-0.08|0.15|||Chi-squared|||Analysis is for self-reported compliance||0.15|-0.08|0.643
73884576|NCT02766023|147302875|SUPERIORITY||Risk Difference (RD)|0.05||||0.446|TWO_SIDED|95.0|-0.07|0.17|||Chi-squared|||Analysis is for compliance assessed by staining.||0.17|-0.07|0.446
73884577|NCT02766023|147302884|SUPERIORITY||Odds Ratio (OR)|79.64|||<|0.001|TWO_SIDED|95.0|29.02|218.57|||Chi-squared|||||218.57|29.02|<0.001
73884578|NCT02766023|147302892|SUPERIORITY||Odds Ratio (OR)|72.78|||<|0.001|TWO_SIDED|95.0|28.07|188.66|||Chi-squared|||||188.66|28.07|<0.001
73884579|NCT02766023|147302893|SUPERIORITY||Odds Ratio (OR)|0.54||||0.03|TWO_SIDED|95.0|0.31|0.94|||Chi-squared|||||0.94|0.31|0.030
73888365|NCT03594110|147309578|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.83||||0.2932|TWO_SIDED|95.0|0.59|1.17|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||1.17|0.59|0.2932
74074456|NCT03966365|147701637|OTHER|||||||0.081|||||||Chi-squared, Corrected|||Green lissamine treatment groups||||0.081
74074457|NCT03966365|147701637|OTHER|||||||0.49|||||||Chi-squared, Corrected|||Fluorescein treatment groups||||0.490
74074458|NCT03966365|147701638|OTHER|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
74074459|NCT03966365|147701639|OTHER|||||||0.031|||||||Chi-squared, Corrected|||||||0.031
74074460|NCT03966365|147701641|OTHER|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||||||0.651
74074461|NCT01569152|147701644|SUPERIORITY_OR_OTHER||Difference of percentages|43.9|||<|0.001|TWO_SIDED|95.0|24.52|63.28|||Cochran-Mantel-Haenszel|||||63.28|24.52|<0.001
74074462|NCT01569152|147701645|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.53|-0.43|||Constrained Longitudinal Data Analysis|||||-0.43|-1.53|<0.001
74074463|NCT01569152|147701646|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.11|||<|0.001|TWO_SIDED|95.0|-1.62|-0.6|||Constrained Longitudinal Data Analysis|||||-0.60|-1.62|<0.001
74074464|NCT01569152|147701647|SUPERIORITY_OR_OTHER||Difference in percentages|14.63||||0.044|TWO_SIDED|95.0|0.83|28.44|||Cochran-Mantel-Haenszel|||||28.44|0.83|0.044
74074465|NCT01569152|147701650|SUPERIORITY_OR_OTHER||Difference in percentages|31.71||||0.004|TWO_SIDED|95.0|11.29|52.13|||Cochran-Mantel-Haenszel|||||52.13|11.29|0.004
74074466|NCT01569152|147701651|SUPERIORITY_OR_OTHER||Difference in percentages|29.27||||0.007|TWO_SIDED|95.0|8.9|49.63|||Cochran-Mantel-Haenszel|||||49.63|8.90|0.007
74074467|NCT01569152|147701652|SUPERIORITY_OR_OTHER||Difference in percentages|9.76||||0.039|TWO_SIDED|95.0|0.67|18.84|||Cochran-Mantel-Haenszel|||||18.84|0.67|0.039
74074468|NCT01569152|147701653|SUPERIORITY_OR_OTHER||Difference in percentages|12.2||||0.018|TWO_SIDED|95.0|2.18|22.21|||Cochran-Mantel-Haenszel|||||22.21|2.18|0.018
74074469|NCT01569152|147701656|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.75||||0.028|TWO_SIDED|95.0|-8.99|-0.52|||Constrained Longitudinal Data Analysis|||||-0.52|-8.99|0.028
74074470|NCT01569152|147701657|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.65||||0.11|TWO_SIDED|95.0|-5.91|0.62|||Constrained Longitudinal Data Analysis|||||0.62|-5.91|0.110
74074471|NCT01569152|147701658|SUPERIORITY_OR_OTHER||Difference in least squares means|-10.56||||0.002|TWO_SIDED|95.0|-16.97|-4.15|||Constrained Longitudinal Data Analysis|||||-4.15|-16.97|0.002
74074472|NCT01569152|147701661|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.84|||<|0.001|TWO_SIDED|95.0|-29.98|-11.71|||Constrained Longitudinal Data Analysis|||||-11.71|-29.98|<0.001
74074473|NCT01569152|147701662|SUPERIORITY_OR_OTHER||Difference in least squares means|-19.48|||<|0.001|TWO_SIDED|95.0|-29.69|-9.28|||Constrained Longitudinal Data Analysis|||||-9.28|-29.69|<0.001
74074474|NCT01569152|147701663|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.69|||<|0.001|TWO_SIDED|95.0|-31.29|-10.09|||Constrained Longitudinal Data Analysis|||||-10.09|-31.29|<0.001
74074475|NCT01569152|147701664|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62|||<|0.001|TWO_SIDED|95.0|-0.84|-0.4|||Constrained Longitudinal Data Analysis|||||-0.40|-0.84|< 0.001
74074476|NCT01569152|147701665|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.59||||0.007|TWO_SIDED|95.0|-2.73|-0.45|||Constrained Longitudinal Data Analysis|||||-0.45|-2.73|0.007
74074477|NCT01569152|147701666|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.9||||0.315|TWO_SIDED|95.0|-14.54|4.74|||Constrained Longitudinal Data Analysis|||||4.74|-14.54|0.315
74074478|NCT01569152|147701668|SUPERIORITY_OR_OTHER||Difference in percentages|31.71|||<|0.001|TWO_SIDED|95.0|15.56|47.86|||Cochran-Mantel-Haenszel|||||47.86|15.56|<0.001
74074479|NCT01523899|147701670|SUPERIORITY||Mean Difference (Final Values)|0.145|||||TWO_SIDED|95.0||||Pearson chi squared, Fisher exact, 2 sample t-tests||||||||
74074480|NCT01523899|147701671|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
74074481|NCT00824265|147701674|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.0032|TWO_SIDED|95.0|0.51|0.88|||Log Rank|||||0.88|0.51|0.0032
74074482|NCT00824265|147701675|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.1427|TWO_SIDED|95.0|0.59|1.09|||Log Rank|||||1.09|0.59|0.1427
74074483|NCT00824265|147701676|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.449|TWO_SIDED|95.0|0.85|1.37|||Log Rank|||||1.37|0.85|0.4490
74074484|NCT00824265|147701677|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0878|TWO_SIDED|95.0|0.56|1.05|||Log Rank|||||1.05|0.56|0.0878
73884580|NCT01488045|147302895|EQUIVALENCE|We compared patient satisfaction for those receiving the 2 sedation regimens using the Schuirmann 2 one-sided t test procedure.15 The groups were declared to be equivalent in terms of patient satisfaction if the 90% CI for the difference in mean satisfaction had outer boundaries indicating \<5% difference on the 100-point VAS. Nonequivalence was declared if the lower 90% CI boundary for the difference was less than -5.0, or if the upper 90% CI boundary for the difference was \>5.0.|Mean Difference (Final Values)|-14.0741|STANDARD_DEVIATION|22.2|||TWO_SIDED|95.0|-18.5|-9.6||||||To calculate the required sample size for this study, the equivalence limit was set at 5 units difference on the VAS, with an expected mean difference of 0. The common SD of 16.2 was estimated based on the range of expected scores for the VAS from Ulmer et al. Using these inputs, a total sample size of 262 patients was estimated to have 80% power to reject the null hypothesis that the test and standard were not equivalent and conclude that they were equivalent.||-9.6|-18.5|
73884581|NCT00989911|147302913|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
73884582|NCT00656513|147302917|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||An effect size of 0.50 was chosen for sample size calculation. On the basis of a 2-sided t test with alpha= 0.05 and 1 interim analysis, 130 patients were required for 80% statistical power. Adjustment by 10% for loss to follow-up and retrospective ineligibility of recruited study participants yielded a sample size of 144 patients. Actual power given only 96 patients was 68.6%||||0.45
73884583|NCT00656513|147302919|SUPERIORITY|||||||0.11||||||Two-sided test of values at 4 months.|Wilcoxon (Mann-Whitney)|||||||0.11
73884584|NCT00656513|147302919|SUPERIORITY|||||||0.31||||||Two-sided test of values at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.31
73884585|NCT00656513|147302919|SUPERIORITY|||||||0.21||||||Two-sided test of values at 15 months.|Wilcoxon (Mann-Whitney)|||||||0.21
73884586|NCT00656513|147302920|SUPERIORITY|||||||0.35||||||4-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.35
73884587|NCT00656513|147302920|SUPERIORITY|||||||0.78||||||4 months Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.78
74074485|NCT00824265|147701678|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0036|TWO_SIDED|95.0|0.45|0.87|||Log Rank|||||0.87|0.45|0.0036
74074486|NCT00824265|147701679|SUPERIORITY_OR_OTHER_LEGACY|Participants in the ITT population|Hazard Ratio (HR)|0.77||||0.1143|TWO_SIDED|95.0|0.55|1.08|||Log Rank|||||1.08|0.55|0.1143
74074487|NCT00824265|147701679|SUPERIORITY_OR_OTHER_LEGACY|Participants who took anti-cancer therapies|Hazard Ratio (HR)|0.67||||0.0109|TWO_SIDED|95.0|0.48|0.94|||Log Rank|||||0.94|0.48|0.0109
74074488|NCT00824265|147701682|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
74074489|NCT00824265|147701683|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||Cochran-Mantel-Haenszel|||||||0.0166
74074490|NCT00365300|147701741|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||1|||||||Fisher Exact|||||||1.0
74074491|NCT01179048|147701748|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \>=1.3 against Ha: HR \<1.3 was less than 2.5% (or equivalent to 5% in two-sided test). If non-inferiority was established for the primary outcome, a test for superiority was to be performed.|Hazard Ratio (HR)|0.868|||<|0.001|TWO_SIDED|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for non-inferiority (hazard ratio \>=1.3).|Regression, Cox|||The primary endpoint was evaluated using the Cox regression model to estimate the hazard ratio (HR) (liraglutide/placebo) and the 2-sided 95% confidence interval (CI) including treatment group as factor. Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \>=1.3 against Ha: HR \<1.3 was less than 2.5% (or equivalent to 5% in two-sided test).||0.968|0.778|<0.001
74074492|NCT01179048|147701748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.005|TWO_SIDED|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for superiority (hazard ratio\>=1.0).|Regression, Cox|||If non-inferiority was established for the primary outcome, a test for superiority was performed. Superiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.0 or equivalent if the p-value for the one-sided test of H0: HR \>=1.0 against Ha: HR \<1.0 was less than 2.5% (or equivalent to 5% in two-sided test).||0.968|0.778|0.005
74074493|NCT01179048|147701749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.881|||||TWO_SIDED|95.0|0.807|0.962|||Regression, Cox|The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.||||0.962|0.807|
74074494|NCT01179048|147701750|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.847|||||TWO_SIDED|95.0|0.739|0.971|||Regression, Cox|The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.||||0.971|0.739|
74074495|NCT01179048|147701751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.783|||||TWO_SIDED|95.0|0.656|0.934|||Regression, Cox|||Analysis for percentage of subjects experiencing cardiovascular death was done by Cox regression model with treatment as fixed factor.||0.934|0.656|
74074496|NCT01179048|147701751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.894|||||TWO_SIDED|95.0|0.721|1.107|||Regression, Cox|||Analysis for percentage of subjects experiencing non-fatal stroke was done by Cox regression model with treatment as fixed factor||1.107|0.721|
73884588|NCT00656513|147302920|SUPERIORITY|||||||0.12||||||4 months Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.12
73884589|NCT00656513|147302920|SUPERIORITY|||||||0.28||||||4-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
73884590|NCT00656513|147302920|SUPERIORITY|||||||0.98||||||6-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.98
73884591|NCT00656513|147302920|SUPERIORITY|||||||0.28||||||6-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
74074497|NCT01179048|147701751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878|||||TWO_SIDED|95.0|0.747|1.031|||Regression, Cox|||Analysis for percentage of subjects experiencing non-fatal myocardial infarction was done by Cox regression model with treatment as fixed factor||1.031|0.747|
74074498|NCT01179048|147701751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.763|1.258|||Regression, Cox|||Analysis for percentage of subjects experiencing hospitalisation for unstable angina pectoris was done by Cox regression model with treatment as fixed factor||1.258|0.763|
74074499|NCT01179048|147701751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912|||||TWO_SIDED|95.0|0.797|1.044|||Regression, Cox|||Analysis for percentage of subjects experiencing coronary revascularisation was done by Cox regression model with treatment as fixed factor||1.044|0.797|
74074500|NCT01179048|147701751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872|||||TWO_SIDED|95.0|0.727|1.046|||Regression, Cox|||Analysis for percentage of subjects experiencing hospitalisation for heart failure was done by Cox regression model with treatment as fixed factor||1.046|0.727|
74074501|NCT01179048|147701752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841|||||TWO_SIDED|95.0|0.73|0.969|||Regression, Cox|||Analysis for percentage of subjects experiencing a first microvascular event was done by Cox regression model with treatment as fixed factor.||0.969|0.730|
74074502|NCT01179048|147701753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.782|||||TWO_SIDED|95.0|0.666|0.918|||Regression, Cox|||Analysis for percentage of subjects experiencing a composite nephropathy event was done by Cox regression model with treatment as fixed factor.||0.918|0.666|
74074503|NCT01179048|147701753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738|||||TWO_SIDED|95.0|0.602|0.905|||Regression, Cox|||Analysis for percentage of subjects experiencing a new onset of persistant macroalbuminaria event was done by Cox regression model with treatment as fixed factor.||0.905|0.602|
74074504|NCT01179048|147701753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.667|1.189|||Regression, Cox|||Analysis for percentage of subjects experiencing persistent doubling of serum creatinine was done by Cox regression model with treatment as fixed factor.||1.189|0.667|
74074505|NCT01179048|147701753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.869|||||TWO_SIDED|95.0|0.607|1.244|||Regression, Cox|||Analysis for percentage of subjects experiencing a need for continuous renal-replacement therapy was done by Cox regression model with treatment as fixed factor.||1.244|0.607|
74074506|NCT01179048|147701753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.593|||||TWO_SIDED|95.0|0.521|4.869|||Regression, Cox|||Analysis for percentage of subjects experiencing death due to renal disease was done by Cox regression model with treatment as fixed factor.||4.869|0.521|
74074507|NCT01179048|147701753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.149|||||TWO_SIDED|95.0|0.869|1.519|||Regression, Cox|||Analysis for percentage of subjects experiencing composite retinopathy was done by Cox regression model with treatment as fixed factor.||1.519|0.869|
74074508|NCT01179048|147701753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.159|||||TWO_SIDED|95.0|0.869|1.546|||Regression, Cox|||Analysis for percentage of subjects experiencing treatment with photocoagulation or intravitreal agents was done by Cox regression model with treatment as fixed factor.||1.546|0.869|
74074509|NCT01179048|147701753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.335|||||TWO_SIDED|95.0|0.004|30.847|||Regression, Cox|||Analysis for percentage of subjects experiencing development of diabetes-related blindness was done by Cox regression model with treatment as fixed factor.||30.847|0.004|
74074510|NCT01179048|147701753|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.454|||||TWO_SIDED|95.0|0.845|2.502|||Regression, Cox|||Analysis for percentage of subjects experiencing vitreous haemorrhage was done by Cox regression model with treatment as fixed factor.||2.502|0.845|
74074511|NCT02627924|147701759|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
74074512|NCT02627924|147701760|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
74074513|NCT02627924|147701762|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12||||<0.0001
74074514|NCT02627924|147701762|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24||||<0.0001
74074515|NCT02627924|147701762|OTHER|||||||0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12||||0.0001
74074516|NCT02627924|147701762|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24||||<0.0001
74074517|NCT02627924|147701763|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks||||<0.0001
74074518|NCT02627924|147701763|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks||||<0.0001
74074519|NCT02627924|147701764|OTHER|||||||0.0098|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12||||0.0098
73884592|NCT00656513|147302920|SUPERIORITY|||||||0.13||||||6-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.13
73884593|NCT00656513|147302920|SUPERIORITY|||||||0.58||||||6-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.58
73884594|NCT00656513|147302920|SUPERIORITY|||||||0.88||||||9-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.88
73884595|NCT00656513|147302920|SUPERIORITY|||||||0.09||||||9-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.09
73884596|NCT00656513|147302920|SUPERIORITY|||||||0.49||||||9-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.49
74074520|NCT02627924|147701764|OTHER|||||||0.0015|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24||||0.0015
74074521|NCT02627924|147701764|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12||||<0.0001
74074522|NCT02627924|147701764|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24||||<0.0001
74074523|NCT00959660|147701771|SUPERIORITY||||||<|0.001||||||Main effects analysis with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||<0.001
74074524|NCT00959660|147701771|SUPERIORITY||||||<|0.001||||||Main effects analysis with Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||<0.001
74074525|NCT00959660|147701772|SUPERIORITY|||||||0.004||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||0.004
74074526|NCT00959660|147701772|SUPERIORITY|||||||0.43||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||0.43
74074527|NCT00959660|147701773|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass||||<0.001
74074528|NCT00959660|147701773|SUPERIORITY|||||||0.001||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass||||0.001
74074529|NCT00959660|147701773|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass||||<0.001
73884597|NCT00656513|147302920|SUPERIORITY|||||||0.45||||||9-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.45
73884598|NCT00656513|147302920|SUPERIORITY|||||||0.45||||||15-month Physical Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.45
73884599|NCT00656513|147302920|SUPERIORITY|||||||0.3||||||15-month Pain/Discomfort; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.30
74074530|NCT00959660|147701773|SUPERIORITY|||||||0.25||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass||||0.25
74074531|NCT00959660|147701774|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat||||<0.001
73884600|NCT00656513|147302920|SUPERIORITY|||||||0.48||||||15-month Personal/Psychological Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.48
73884601|NCT00656513|147302920|SUPERIORITY|||||||0.68||||||15-month Social Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.68
73884602|NCT00656513|147302921|SUPERIORITY|||||||0.97||||||4-month score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.97
73884603|NCT00656513|147302921|SUPERIORITY|||||||0.83||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.83
74074532|NCT00959660|147701774|SUPERIORITY|||||||0.26||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat||||0.26
74074533|NCT00959660|147701774|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle||||<0.001
73884604|NCT00656513|147302921|SUPERIORITY|||||||0.28||||||9-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
73884605|NCT00656513|147302921|SUPERIORITY|||||||0.89||||||15-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.89
74074534|NCT00959660|147701774|SUPERIORITY|||||||0.26||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle||||0.26
73884606|NCT00656513|147302922|SUPERIORITY|||||||0.54||||||4-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.54
73884607|NCT00656513|147302922|SUPERIORITY|||||||0.99||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
73884608|NCT00656513|147302922|SUPERIORITY|||||||0.56||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.56
73884609|NCT00656513|147302922|SUPERIORITY|||||||0.58||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.58
73884610|NCT00656513|147302923|SUPERIORITY|||||||0.14||||||Two-sided test, significance level 0.05|t-test, 2 sided|||||||0.14
74074535|NCT01297348|147701775|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.01|||||TWO_SIDED|95.0|1.23|3.29||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95 percent (%) confidence interval (CI) was reported for current users.||3.29|1.23|
74074536|NCT01297348|147701775|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.99|||||TWO_SIDED|95.0|0.39|22.8||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95% CI was reported for past users.||22.80|0.39|
74074537|NCT01297348|147701775|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.49|||||TWO_SIDED|95.0|2.02|6.02||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for current users.||6.02|2.02|
74074538|NCT01297348|147701775|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.07|||||TWO_SIDED|95.0|0.34|27.47||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for past users.||27.47|0.34|
74074539|NCT01297348|147701776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.85|2.67||||||Current user, case and matched control: Odds ratio (Lybrel/EE-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).||2.67|0.85|
74074540|NCT01297348|147701776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53|||||TWO_SIDED|95.0|0.98|6.54||||||Current user, case and matched control: Odds ratio (Lybrel/Levo-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).||6.54|0.98|
74074541|NCT01520909|147701777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.96|||<|0.001|TWO_SIDED|95.0|2.29|140.93|||Cochran-Mantel-Haenszel|The proportion of participants achieving platelet counts \>=50 Gi/L for those participants receiving eltrombopag versus placebo was compared.||Indicated significance at the 5% (two-sided) level of significance||140.93|2.29|<0.001
74074542|NCT01520909|147701778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.33|||<|0.001|TWO_SIDED|95.0|8.15|78.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized linear mixed model||||78.73|8.15|<0.001
74074543|NCT02589808|147701813|OTHER|||||||0.0005|||||||Kappa|||||||0.0005
74074544|NCT01171690|147701840|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Matched pairs t test|||Matched pairs||||0.01
74074545|NCT02087904|147701846|SUPERIORITY||LS Mean Difference|-0.3||||0.834|TWO_SIDED|95.0|-3.13|2.53||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and Kellgren-Lawrence (K-L) grade as the main factors and baseline as a covariate.|ANCOVA|||||2.53|-3.13|0.834
74074546|NCT02087904|147701846|SUPERIORITY||LS Mean Difference|-2.9||||0.05|TWO_SIDED|95.0|-5.73|0.01||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.01|-5.73|0.05
74074547|NCT02087904|147701846|SUPERIORITY||LS Mean Difference|-1.2||||0.415|TWO_SIDED|95.0|-4.0|1.66||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.66|-4.00|0.415
74074548|NCT02087904|147701847|SUPERIORITY||LS Mean Difference|0.06||||0.145|TWO_SIDED|95.0|-0.021|0.141||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.141|-0.021|0.145
73884611|NCT03405792|147302924|OTHER|||||||||||||||||We will use one-sample log-rank test to compare PFS between the triple combination arm relative to the historical control arm.|We took a look at median survival time and CI of our population and we compared it to the median PFS and CI of the historical control descriptively. There is no yielded P value.|||
74074549|NCT02087904|147701847|SUPERIORITY||LS Mean Difference|-0.03||||0.52|TWO_SIDED|95.0|-0.11|0.056||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.056|-0.11|0.52
74074550|NCT02087904|147701847|SUPERIORITY||LS Mean Difference|0.06||||0.159|TWO_SIDED|95.0|-0.023|0.139||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.139|-0.023|0.159
74074551|NCT02087904|147701848|SUPERIORITY||LS Mean Difference|0.22||||0.897|TWO_SIDED|95.0|-3.193|3.642||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||3.642|-3.193|0.897
74074552|NCT02087904|147701848|SUPERIORITY||LS Mean Difference|-1.07||||0.542|TWO_SIDED|95.0|-4.515|2.377||P-value for test of difference between ABT-981 100 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.377|-4.515|0.542
74074553|NCT02087904|147701848|SUPERIORITY||LS Mean Difference|-1.52||||0.385|TWO_SIDED|95.0|-4.95|1.916||P-value for test of difference between ABT-981 200 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.916|-4.95|0.385
74074554|NCT02087904|147701849|SUPERIORITY||LS Mean Difference|-0.08||||0.384|TWO_SIDED|95.0|-0.249|0.096||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.096|-0.249|0.384
74074555|NCT02087904|147701849|SUPERIORITY||LS Mean Difference|-0.15||||0.095|TWO_SIDED|95.0|-0.324|0.026||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.026|-0.324|0.095
74074556|NCT02087904|147701849|SUPERIORITY||LS Mean Difference|-0.14||||0.106|TWO_SIDED|95.0|-0.314|0.03||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.03|-0.314|0.106
74074557|NCT02087904|147701850|SUPERIORITY||LS Mean Difference|-1.1||||0.818|TWO_SIDED|95.0|-10.22|8.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||8.08|-10.22|0.818
74074558|NCT02087904|147701850|SUPERIORITY||LS Mean Difference|-7.6||||0.109|TWO_SIDED|95.0|-16.83|1.69||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.69|-16.83|0.109
74074559|NCT02087904|147701850|SUPERIORITY||LS Mean Difference|-3.4||||0.465|TWO_SIDED|95.0|-12.58|5.76||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||5.76|-12.58|0.465
74074560|NCT02087904|147701851|SUPERIORITY||LS Mean Difference|-2.1||||0.666|TWO_SIDED|95.0|-11.76|7.52||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||7.52|-11.76|0.666
73884612|NCT03405792|147302925|OTHER||||||||||||||||||Every participant (26/26; 100%) experienced an adverse event.|||
73884613|NCT03882021|147302938|OTHER||Kaplan Meier Survival Estimate|57.2|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|51.2|62.8|||||Kaplan-Meier estimate of freedom from recurrence after removal from AAD at one year.|||62.8|51.2|
73884614|NCT03882021|147302939|OTHER|Kaplan Meier Estimate of freedom from symptomatic recurrence.|Kaplan-Meier Survival Estimate|61.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|55.8|67.1|||||Kaplan-Meier estimate of freedom from symptomatic AF/AFL/AT recurrence after removal from AAD|||67.1|55.8|
74074561|NCT02087904|147701851|SUPERIORITY||LS Mean Difference|-9.2||||0.065|TWO_SIDED|95.0|-18.95|0.56||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.56|-18.95|0.065
73884615|NCT03882021|147302940|OTHER|Kaplan Meier estimate of single procedure clinical success.|Kaplan-Meier Survival Estimate|79.4|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|74.2|83.6|||||Kaplan-Meier estimate of freedom from symptomatic AF/AFL/AT without new or increased dose of Class I/III AAD at one year.|||83.6|74.2|
73884616|NCT03882021|147302941|OTHER|Kaplan Meier estimate of freedom from AF/AFL/AT|Kaplan Meier Survival Estimate|75.5|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|69.9|80.1|||||Kaplan Meier estimate of freedom from AF/AFL/AT at 12 months.|||80.1|69.9|
73884617|NCT00333775|147302973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0318|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.0318
73884618|NCT00333775|147302973|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.72||||0.0036|TWO_SIDED|95.0|0.57|0.9|||Log Rank|||||0.90|0.57|0.0036
74074562|NCT02087904|147701851|SUPERIORITY||LS Mean Difference|-7.2||||0.145|TWO_SIDED|95.0|-16.84|2.49||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.49|-16.84|0.145
74074563|NCT02087904|147701852|SUPERIORITY||LS Mean Difference|-3.2||||0.558|TWO_SIDED|95.0|-14.03|7.59||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||7.59|-14.03|0.558
74074564|NCT02087904|147701852|SUPERIORITY||LS Mean Difference|-5.8||||0.295|TWO_SIDED|95.0|-16.77|5.11||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||5.11|-16.77|0.295
74074565|NCT02087904|147701852|SUPERIORITY||LS Mean Difference|-6.8||||0.218|TWO_SIDED|95.0|-17.63|4.04||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||4.04|-17.63|0.218
74074566|NCT02087904|147701853|SUPERIORITY||LS Mean Difference|-0.6||||0.664|TWO_SIDED|95.0|-3.58|2.28||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.28|-3.58|0.664
74074567|NCT02087904|147701853|SUPERIORITY||LS Mean Difference|-2.7||||0.075|TWO_SIDED|95.0|-5.67|0.28||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.28|-5.67|0.075
74074568|NCT02087904|147701853|SUPERIORITY||LS Mean Difference|-2.4||||0.107|TWO_SIDED|95.0|-5.33|0.52||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.52|-5.33|0.107
74074569|NCT02087904|147701854|SUPERIORITY||LS Mean Difference|0.5||||0.5|TWO_SIDED|95.0|-4.26|2.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.08|-4.26|0.5
74074570|NCT02087904|147701854|SUPERIORITY||LS Mean Difference|-2.2||||0.186|TWO_SIDED|95.0|-5.39|1.05||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.05|-5.39|0.186
74074571|NCT02087904|147701854|SUPERIORITY||LS Mean Difference|-2.3||||0.157|TWO_SIDED|95.0|-5.46|0.88||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.88|-5.46|0.157
73884619|NCT00333775|147302976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1105|TWO_SIDED|95.0|0.69|1.04|||Log Rank|||||1.04|0.69|0.1105
73884620|NCT00333775|147302976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0241|TWO_SIDED|95.0|0.65|0.97|||Log Rank|||||0.97|0.65|0.0241
73884621|NCT00333775|147302977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6962|TWO_SIDED|95.0|0.62|1.37|||Log Rank|||||1.37|0.62|0.6962
73884622|NCT00333775|147302977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0765|TWO_SIDED|95.0|0.45|1.04|||Log Rank|||||1.04|0.45|0.0765
73884623|NCT03486912|147302982|SUPERIORITY||Odds Ratio (OR)|0.88||||0.773|TWO_SIDED|95.0|0.3|2.62|||Cochran-Mantel-Haenszel|||||2.62|0.30|0.773
73884624|NCT03486912|147302982|SUPERIORITY||Odds Ratio (OR)|0.72||||0.544|TWO_SIDED|95.0|0.23|2.23|||Cochran-Mantel-Haenszel|||||2.23|0.23|0.544
73884625|NCT03486912|147302982|SUPERIORITY||Odds Ratio (OR)|0.88||||0.811|TWO_SIDED|95.0|0.3|2.62|||Cochran-Mantel-Haenszel|||||2.62|0.30|0.811
73884626|NCT03486912|147302983|SUPERIORITY||Odds Ratio (OR)|1.12||||0.836|TWO_SIDED|95.0|0.4|3.09|||Cochran-Mantel-Haenszel|||||3.09|0.40|0.836
73884627|NCT03486912|147302983|SUPERIORITY||Odds Ratio (OR)|0.86||||0.763|TWO_SIDED|95.0|0.3|2.46|||Cochran-Mantel-Haenszel|||||2.46|0.30|0.763
73884628|NCT03486912|147302983|SUPERIORITY||Odds Ratio (OR)|0.89||||0.821|TWO_SIDED|95.0|0.32|2.51|||Cochran-Mantel-Haenszel|||||2.51|0.32|0.821
73884629|NCT03486912|147302984|SUPERIORITY||Odds Ratio (OR)|1.13||||0.837|TWO_SIDED|95.0|0.39|3.25|||Cochran-Mantel-Haenszel|||||3.25|0.39|0.837
73884630|NCT03486912|147302984|SUPERIORITY||Odds Ratio (OR)|1.53||||0.359|TWO_SIDED|95.0|0.54|4.4|||Cochran-Mantel-Haenszel|||||4.40|0.54|0.359
73884631|NCT03486912|147302984|SUPERIORITY||Odds Ratio (OR)|1.26||||0.627|TWO_SIDED|95.0|0.44|3.61|||Cochran-Mantel-Haenszel|||||3.61|0.44|0.627
73884632|NCT03486912|147302985|SUPERIORITY||Odds Ratio (OR)|1.12||||0.864|TWO_SIDED|95.0|0.4|3.16|||Cochran-Mantel-Haenszel|||||3.16|0.40|0.864
73884633|NCT03486912|147302985|SUPERIORITY||Odds Ratio (OR)|0.85||||0.743|TWO_SIDED|95.0|0.29|2.49|||Cochran-Mantel-Haenszel|||||2.49|0.29|0.743
73884634|NCT03486912|147302985|SUPERIORITY||Odds Ratio (OR)|0.79||||0.63|TWO_SIDED|95.0|0.27|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.27|0.630
73884635|NCT03486912|147302986|SUPERIORITY||Odds Ratio (OR)|1.43||||0.477|TWO_SIDED|95.0|0.48|4.25|||Cochran-Mantel-Haenszel|||||4.25|0.48|0.477
73884636|NCT03486912|147302986|SUPERIORITY||Odds Ratio (OR)|1.04||||0.814|TWO_SIDED|95.0|0.32|3.44|||Cochran-Mantel-Haenszel|||||3.44|0.32|0.814
73884637|NCT03486912|147302986|SUPERIORITY||Odds Ratio (OR)|0.64||||0.367|TWO_SIDED|95.0|0.21|1.93|||Cochran-Mantel-Haenszel|||||1.93|0.21|0.367
73884638|NCT03486912|147302987|SUPERIORITY|||||||0.309|||||||Cochran-Mantel-Haenszel|||||||0.309
73884639|NCT03486912|147302987|SUPERIORITY|||||||0.146|||||||Cochran-Mantel-Haenszel|||||||0.146
74074572|NCT02087904|147701855|SUPERIORITY||LS Mean Difference|0.2||||0.319|TWO_SIDED|95.0|-0.23|0.69||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.69|-0.23|0.319
74074573|NCT02087904|147701855|SUPERIORITY||LS Mean Difference|-0.1||||0.564|TWO_SIDED|95.0|-0.6|0.33||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.33|-0.6|0.564
73884640|NCT03486912|147302987|SUPERIORITY|||||||0.317|||||||Cochran-Mantel-Haenszel|||||||0.317
73884641|NCT03486912|147302988|SUPERIORITY||Odds Ratio (OR)|6.91||||0.054|TWO_SIDED|95.0|0.76|325.97|||Cochran-Mantel-Haenszel|||||325.97|0.76|0.054
73884642|NCT03486912|147302988|SUPERIORITY||Odds Ratio (OR)|12.21||||0.004|TWO_SIDED|95.0|1.5|549.08|||Cochran-Mantel-Haenszel|||||549.08|1.50|0.004
73884643|NCT03486912|147302988|SUPERIORITY||Odds Ratio (OR)|5.59||||0.087|TWO_SIDED|95.0|0.57|271.11|||Cochran-Mantel-Haenszel|||||271.11|0.57|0.087
73884644|NCT02491684|147302989|SUPERIORITY_OR_OTHER||Ratio of proportions|1.29||||0.645|TWO_SIDED|95.0|0.43|3.85|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||3.85|0.43|0.645
73884645|NCT02491684|147302990|SUPERIORITY_OR_OTHER||Ratio of proportions|1.97||||0.411|TWO_SIDED|95.0|0.39|9.89|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 7|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||9.89|0.39|0.411
73884646|NCT02491684|147302990|SUPERIORITY_OR_OTHER||Ratio of proportions|1.25||||0.659|TWO_SIDED|95.0|0.46|3.41|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||3.41|0.46|0.659
73884647|NCT02491684|147302991|SUPERIORITY_OR_OTHER||Ratio of proportions|1.1||||0.944|TWO_SIDED|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 14|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||15.79|0.08|0.944
73884648|NCT02491684|147302991|SUPERIORITY_OR_OTHER||Ratio of proportions|1.1||||0.944|TWO_SIDED|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||15.79|0.08|0.944
73884649|NCT02491684|147302992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.634|TWO_SIDED|95.0|0.45|3.77|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first severe exacerbation within 30 days of treatment start.||3.77|0.45|0.634
73884650|NCT02491684|147302993|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.973|TWO_SIDED|95.0|0.07|16.78|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first moderate exacerbation within 30 days of treatment start.||16.78|0.07|0.973
73884651|NCT02491684|147302995|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|0.09||||0.495|TWO_SIDED|95.0|-0.17|0.35|||ANCOVA|Change from baseline is analysed using an Analysis of Covariance (ANCOVA) model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo for change from baseline in total score at Visit 4.|Analysis of change from baseline in total score at Visit 4.||0.35|-0.17|0.495
74074574|NCT02087904|147701855|SUPERIORITY||LS Mean Difference|0.0||||0.966|TWO_SIDED|95.0|-0.45|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.47|-0.45|0.966
74074575|NCT02087904|147701856|SUPERIORITY||LS Mean Difference|0.1||||0.602|TWO_SIDED|95.0|-0.41|0.7||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.7|-0.41|0.602
74074576|NCT02087904|147701856|SUPERIORITY||LS Mean Difference|0.0||||0.953|TWO_SIDED|95.0|-0.55|0.58||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.58|-0.55|0.953
74074577|NCT02087904|147701856|SUPERIORITY||LS Mean Difference|-0.1||||0.83|TWO_SIDED|95.0|-0.61|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.49|-0.61|0.83
74074578|NCT02087904|147701857|SUPERIORITY||LS Mean Difference|0.7||||0.804|TWO_SIDED|95.0|-4.91|6.33||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||6.33|-4.91|0.804
74074579|NCT02087904|147701857|SUPERIORITY||LS Mean Difference|-1.1||||0.699|TWO_SIDED|95.0|-6.9|4.63||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||4.63|-6.9|0.699
74074580|NCT02087904|147701857|SUPERIORITY||LS Mean Difference|1.4||||0.636|TWO_SIDED|95.0|-4.37|7.14||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||7.14|-4.37|0.636
74074581|NCT02087904|147701857|SUPERIORITY||LS Mean Difference|0.9||||0.756|TWO_SIDED|95.0|-4.91|6.76||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||6.76|-4.91|0.756
74074582|NCT02087904|147701857|SUPERIORITY||LS Mean Difference|-5.6||||0.068|TWO_SIDED|95.0|-11.55|0.42||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||0.42|-11.55|0.068
73884652|NCT02491684|147302995|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.715|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 6.||0.38|-0.26|0.715
73884653|NCT02491684|147302995|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.687|TWO_SIDED|95.0|-0.42|0.28|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 8.||0.28|-0.42|0.687
73884654|NCT02491684|147302996|SUPERIORITY_OR_OTHER||LS Mean difference|0.11||||0.516|TWO_SIDED|95.0|-0.23|0.45|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-14.||0.45|-0.23|0.516
73884655|NCT02491684|147302996|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.417|TWO_SIDED|95.0|-0.16|0.37|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-7.||0.37|-0.16|0.417
74074583|NCT02087904|147701857|SUPERIORITY||LS Mean Difference|-1.4||||0.649|TWO_SIDED|95.0|-7.34|4.58||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||4.58|-7.34|0.649
74074584|NCT02087904|147701858|SUPERIORITY||LS Mean Difference|-1.0||||0.75|TWO_SIDED|95.0|-7.14|5.14||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||5.14|-7.14|0.75
74074585|NCT02087904|147701858|SUPERIORITY||LS Mean Difference|-2.6||||0.409|TWO_SIDED|95.0|-8.82|3.6||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.6|-8.82|0.409
74074586|NCT02087904|147701858|SUPERIORITY||LS Mean Difference|-3.0||||0.338|TWO_SIDED|95.0|-9.24|3.18||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.18|-9.24|0.338
74074587|NCT02087904|147701858|SUPERIORITY||LS Mean Difference|0.7||||0.817|TWO_SIDED|95.0|-5.59|7.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||7.08|-5.59|0.817
74074588|NCT02087904|147701858|SUPERIORITY||LS Mean Difference|-2.0||||0.544|TWO_SIDED|95.0|-8.37|4.43||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||4.43|-8.37|0.544
73884656|NCT02491684|147302996|SUPERIORITY_OR_OTHER||LS mean difference|0.01||||0.954|TWO_SIDED|95.0|-0.34|0.36|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 8-14.||0.36|-0.34|0.954
74074589|NCT02087904|147701858|SUPERIORITY||LS Mean Difference|-2.5||||0.437|TWO_SIDED|95.0|-8.91|3.86||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||3.86|-8.91|0.437
74074590|NCT02087904|147701859|SUPERIORITY||LS Mean Difference|-2.2||||0.545|TWO_SIDED|95.0|-9.31|4.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||4.92|-9.31|0.545
74074591|NCT02087904|147701859|SUPERIORITY||LS Mean Difference|-0.4||||0.909|TWO_SIDED|95.0|-7.65|6.81||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||6.81|-7.65|0.909
74074592|NCT02087904|147701859|SUPERIORITY||LS Mean Difference|-4.0||||0.278|TWO_SIDED|95.0|-11.23|3.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.25|-11.23|0.278
74074593|NCT02087904|147701859|SUPERIORITY||LS Mean Difference|-1.2||||0.732|TWO_SIDED|95.0|-8.42|5.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||5.92|-8.42|0.732
73884657|NCT02491684|147302996|SUPERIORITY_OR_OTHER||LS Mean difference|0.0||||0.985|TWO_SIDED|95.0|-0.35|0.35|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 15-30.||0.35|-0.35|0.985
74074594|NCT02087904|147701859|SUPERIORITY||LS Mean Difference|-4.6||||0.216|TWO_SIDED|95.0|-11.86|2.69||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||2.69|-11.86|0.216
74074595|NCT02087904|147701859|SUPERIORITY||LS Mean Difference|-9.2||||0.014|TWO_SIDED|95.0|-16.42|-1.88||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||-1.88|-16.42|0.014
74074596|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|0.0||||0.874|TWO_SIDED|95.0|-0.56|0.66||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.66|-0.56|0.874
74074597|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|-0.2||||0.451|TWO_SIDED|95.0|-0.86|0.38||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.38|-0.86|0.451
74074598|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|0.3||||0.331|TWO_SIDED|95.0|-0.31|0.93||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.93|-0.31|0.331
74074599|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|0.0||||0.932|TWO_SIDED|95.0|-0.73|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.67|-0.73|0.932
74074600|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|-0.3||||0.344|TWO_SIDED|95.0|-1.07|0.37||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.37|-1.07|0.344
74074601|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|0.3||||0.489|TWO_SIDED|95.0|-0.47|0.97||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.97|-0.47|0.489
74074602|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|0.2||||0.498|TWO_SIDED|95.0|-0.42|0.85||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.85|-0.42|0.498
74074603|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|0.2||||0.637|TWO_SIDED|95.0|-0.8|0.49||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.49|-0.8|0.637
74074604|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|0.3||||0.367|TWO_SIDED|95.0|-0.35|0.94||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.94|-0.35|0.367
74074605|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|0.1||||0.67|TWO_SIDED|95.0|-0.51|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.79|-0.51|0.67
74074606|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|-0.1||||0.776|TWO_SIDED|95.0|-0.76|0.57||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.57|-0.76|0.776
74074607|NCT02087904|147701860|SUPERIORITY||LS Mean Difference|0.3||||0.387|TWO_SIDED|95.0|-0.37|0.96||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.96|-0.37|0.387
74074608|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|-0.2||||0.661|TWO_SIDED|95.0|-0.86|0.54||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.54|-0.86|0.661
74074609|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|-0.6||||0.122|TWO_SIDED|95.0|-1.26|0.15||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.15|-1.26|0.122
74074610|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|-0.2||||0.507|TWO_SIDED|95.0|-0.94|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.47|-0.94|0.507
74074611|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|-0.1||||0.892|TWO_SIDED|95.0|-0.85|0.74||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.74|-0.85|0.892
74074612|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|-0.3||||0.433|TWO_SIDED|95.0|-1.12|0.48||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.48|-1.12|0.433
74074613|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|0.0||||0.92|TWO_SIDED|95.0|-0.84|0.76||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.76|-0.84|0.92
74074614|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|0.0||||0.957|TWO_SIDED|95.0|-0.68|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.71|-0.68|0.957
74074615|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|-0.4||||0.222|TWO_SIDED|95.0|-1.13|0.26||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.26|-1.13|0.222
74074616|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|-0.4||||0.209|TWO_SIDED|95.0|-1.15|0.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.25|-1.15|0.209
74074617|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|0.1||||0.813|TWO_SIDED|95.0|-0.62|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.79|-0.62|0.813
74074618|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|-0.5||||0.135|TWO_SIDED|95.0|-1.25|0.17||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.17|-1.25|0.135
74074619|NCT02087904|147701861|SUPERIORITY||LS Mean Difference|-0.1||||0.679|TWO_SIDED|95.0|-0.85|0.57||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.57|-0.85|0.679
74074620|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|0.0||||0.978|TWO_SIDED|95.0|-0.76|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.79|-0.76|0.978
74074621|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|0.0||||0.925|TWO_SIDED|95.0|-0.75|0.82||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.82|-0.75|0.925
74074622|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|-0.2||||0.659|TWO_SIDED|95.0|-0.96|0.61||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.61|-0.96|0.659
74074623|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|-0.2||||0.633|TWO_SIDED|95.0|-1.1|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.67|-1.1|0.633
74074624|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|-0.3||||0.46|TWO_SIDED|95.0|-1.23|0.56||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.56|-1.23|0.46
73884658|NCT02491684|147302998|SUPERIORITY_OR_OTHER||LS Mean difference|-0.07||||0.66|TWO_SIDED|95.0|-0.38|0.24|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 6.||0.24|-0.38|0.660
74074625|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|-0.2||||0.663|TWO_SIDED|95.0|-1.1|0.7||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.7|-1.1|0.663
74074626|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|-0.1||||0.696|TWO_SIDED|95.0|-0.89|0.59||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.59|-0.89|0.696
74074627|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|-0.4||||0.278|TWO_SIDED|95.0|-1.16|0.34||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.34|-1.16|0.278
73884659|NCT02491684|147302998|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09||||0.624|TWO_SIDED|95.0|-0.48|0.29|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 8.||0.29|-0.48|0.624
74074628|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|-0.4||||0.357|TWO_SIDED|95.0|-1.1|0.4||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.4|-1.1|0.357
74074629|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|-0.1||||0.761|TWO_SIDED|95.0|-0.87|0.64||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.64|-0.87|0.761
74074630|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|-0.5||||0.218|TWO_SIDED|95.0|-1.02|0.51||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.51|-1.02|0.218
73884660|NCT02491684|147302999|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.309|TWO_SIDED|95.0|-0.51|1.59|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||1.59|-0.51|0.309
73884661|NCT02491684|147303000|SUPERIORITY_OR_OTHER||LS Mean difference|16.98||||0.059|TWO_SIDED|95.0|-0.63|34.6|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||34.60|-0.63|0.059
73884662|NCT02491684|147303000|SUPERIORITY_OR_OTHER||LS Mean difference|19.35||||0.01|TWO_SIDED|95.0|4.66|34.05|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||34.05|4.66|0.010
73884663|NCT02491684|147303000|SUPERIORITY_OR_OTHER||LS Mean difference|14.38||||0.153|TWO_SIDED|95.0|-5.44|34.2|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||34.20|-5.44|0.153
73884664|NCT02491684|147303000|SUPERIORITY_OR_OTHER||LS Mean difference|19.26||||0.096|TWO_SIDED|95.0|-3.44|41.97|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||41.97|-3.44|0.096
73884665|NCT02491684|147303001|SUPERIORITY_OR_OTHER||LS Mean difference|0.07||||0.161|TWO_SIDED|95.0|-0.03|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||0.17|-0.03|0.161
74074631|NCT02087904|147701862|SUPERIORITY||LS Mean Difference|-0.3||||0.513|TWO_SIDED|95.0|-1.02|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.51|-1.02|0.513
74074632|NCT02087904|147701863|SUPERIORITY||LS Mean Difference|0.1||||0.728|TWO_SIDED|95.0|-0.52|0.75||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.75|-0.52|0.728
74074633|NCT02087904|147701863|SUPERIORITY||LS Mean Difference|-0.4||||0.219|TWO_SIDED|95.0|-1.06|0.24||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.24|-1.06|0.219
74074634|NCT02087904|147701863|SUPERIORITY||LS Mean Difference|-0.1||||0.673|TWO_SIDED|95.0|-0.79|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.51|-0.79|0.673
74074635|NCT02087904|147701864|SUPERIORITY||LS Mean Difference|0.0||||0.984|TWO_SIDED|95.0|-0.73|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.71|-0.73|0.984
74074636|NCT02087904|147701864|SUPERIORITY||LS Mean Difference|-0.5||||0.145|TWO_SIDED|95.0|-1.26|0.19||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.19|-1.26|0.145
74074637|NCT02087904|147701864|SUPERIORITY||LS Mean Difference|-0.2||||0.527|TWO_SIDED|95.0|-0.96|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.49|-0.96|0.527
74074638|NCT02087904|147701865|SUPERIORITY||LS Mean Difference|0.1||||0.836|TWO_SIDED|95.0|-0.71|0.87||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.87|-0.71|0.836
74074639|NCT02087904|147701865|SUPERIORITY||LS Mean Difference|-0.1||||0.738|TWO_SIDED|95.0|-0.94|0.66||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.66|-0.94|0.738
74074640|NCT02087904|147701865|SUPERIORITY||LS Mean Difference|-0.4||||0.3|TWO_SIDED|95.0|-1.22|0.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.38|-1.22|0.3
74074641|NCT02087904|147701866|SUPERIORITY||LS Mean Difference|0.5||||0.992|TWO_SIDED|95.0|-101.59|102.62||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||102.62|-101.59|0.992
74074642|NCT02087904|147701866|SUPERIORITY||LS Mean Difference|3.6||||0.948|TWO_SIDED|95.0|-103.95|111.1||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||111.10|-103.95|0.948
74074643|NCT02087904|147701866|SUPERIORITY||LS Mean Difference|-33.1||||0.523|TWO_SIDED|95.0|-134.76|68.65||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||68.65|-134.76|0.523
74074644|NCT02087904|147701866|SUPERIORITY||LS Mean Difference|4.2||||0.799|TWO_SIDED|95.0|-28.47|36.95||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||36.95|-28.47|0.799
74074645|NCT02087904|147701866|SUPERIORITY||LS Mean Difference|9.0||||0.609|TWO_SIDED|95.0|-25.62|43.64||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||43.64|-25.62|0.609
74074646|NCT02087904|147701866|SUPERIORITY||LS Mean Difference|1.6||||0.923|TWO_SIDED|95.0|-30.97|34.19||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||34.19|-30.97|0.923
74074647|NCT02087904|147701866|SUPERIORITY||LS Mean Difference|2.1||||0.937|TWO_SIDED|95.0|-49.88|54.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||54.08|-49.88|0.937
74074648|NCT02087904|147701866|SUPERIORITY||LS Mean Difference|4.1||||0.882|TWO_SIDED|95.0|-50.68|58.95||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||58.95|-50.68|0.882
74074649|NCT02087904|147701866|SUPERIORITY||LS Mean Difference|13.8||||0.602|TWO_SIDED|95.0|-38.05|65.55||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||65.55|-38.05|0.602
74074650|NCT02087904|147701867|SUPERIORITY||LS Mean Difference|-41.7||||0.554|TWO_SIDED|95.0|-180.49|97.04||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||97.04|-180.49|0.554
74074651|NCT02087904|147701867|SUPERIORITY||LS Mean Difference|2.7||||0.97|TWO_SIDED|95.0|-140.86|146.31||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||146.31|-140.86|0.97
74074652|NCT02087904|147701867|SUPERIORITY||LS Mean Difference|-26.1||||0.713|TWO_SIDED|95.0|-165.47|113.32||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||113.32|-165.47|0.713
74074653|NCT02087904|147701867|SUPERIORITY||LS Mean Difference|-25.1||||0.272|TWO_SIDED|95.0|-70.12|19.88||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||19.88|-70.12|0.272
74074654|NCT02087904|147701867|SUPERIORITY||LS Mean Difference|11.1||||0.64|TWO_SIDED|95.0|-35.63|57.8||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||57.8|-35.63|0.64
74074655|NCT02087904|147701867|SUPERIORITY||LS Mean Difference|-11.8||||0.608|TWO_SIDED|95.0|-56.94|33.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||33.38|-56.94|0.608
74074656|NCT02087904|147701867|SUPERIORITY||LS Mean Difference|-40.3||||0.319|TWO_SIDED|95.0|-119.88|39.3||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||39.3|-119.88|0.319
74074657|NCT02087904|147701867|SUPERIORITY||LS Mean Difference|24.4||||0.56|TWO_SIDED|95.0|-58.05|106.91||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||106.91|-58.05|0.56
74074658|NCT02087904|147701867|SUPERIORITY||LS Mean Difference|-28.1||||0.489|TWO_SIDED|95.0|-107.97|51.82||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||51.82|-107.97|0.489
74074659|NCT02087904|147701868|SUPERIORITY||LS Mean Difference|0.0||||0.972|TWO_SIDED|95.0|-0.015|0.015||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.015|-0.015|0.972
73884666|NCT02491684|147303001|SUPERIORITY_OR_OTHER||LS Mean difference|0.08||||0.087|TWO_SIDED|95.0|-0.01|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||0.17|-0.01|0.087
74074660|NCT02087904|147701868|SUPERIORITY||LS Mean Difference|-0.001||||0.929|TWO_SIDED|95.0|-0.017|0.015||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.015|-0.017|0.929
73884667|NCT02491684|147303001|SUPERIORITY_OR_OTHER||LS Mean difference|0.06||||0.28|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||0.16|-0.05|0.280
73884668|NCT02491684|147303001|SUPERIORITY_OR_OTHER||LS Mean difference|0.11||||0.086|TWO_SIDED|95.0|-0.02|0.24|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||0.24|-0.02|0.086
74074661|NCT02087904|147701868|SUPERIORITY||LS Mean Difference|-0.005||||0.543|TWO_SIDED|95.0|-0.02|0.01||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.01|-0.02|0.543
74074662|NCT02087904|147701868|SUPERIORITY||LS Mean Difference|0.008||||0.752|TWO_SIDED|95.0|-0.043|0.059||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.059|-0.043|0.752
74074663|NCT02087904|147701868|SUPERIORITY||LS Mean Difference|0.011||||0.691|TWO_SIDED|95.0|-0.042|0.064||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.064|-0.042|0.691
74074664|NCT02087904|147701868|SUPERIORITY||LS Mean Difference|0.01||||0.71|TWO_SIDED|95.0|-0.041|0.06||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.06|-0.041|0.71
74074665|NCT02087904|147701868|SUPERIORITY||LS Mean Difference|0.0||||0.965|TWO_SIDED|95.0|-0.019|0.02||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.02|-0.019|0.965
74074666|NCT02087904|147701868|SUPERIORITY||LS Mean Difference|-0.002||||0.885|TWO_SIDED|95.0|-0.022|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.019|-0.022|0.885
74074667|NCT02087904|147701868|SUPERIORITY||LS Mean Difference|0.001||||0.887|TWO_SIDED|95.0|-0.018|0.021||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.021|-0.018|0.887
74074668|NCT02087904|147701869|SUPERIORITY||LS Mean Difference|-0.005||||0.619|TWO_SIDED|95.0|-0.024|0.014||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.014|-0.024|0.619
74074669|NCT02087904|147701869|SUPERIORITY||LS Mean Difference|-0.001||||0.952|TWO_SIDED|95.0|-0.02|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.019|-0.02|0.952
74074670|NCT02087904|147701869|SUPERIORITY||LS Mean Difference|-0.003||||0.765|TWO_SIDED|95.0|-0.022|0.016||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.016|-0.022|0.765
74074671|NCT02087904|147701869|SUPERIORITY||LS Mean Difference|-0.04||||0.258|TWO_SIDED|95.0|-0.11|0.03||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.03|-0.11|0.258
74074672|NCT02087904|147701869|SUPERIORITY||LS Mean Difference|0.023||||0.535|TWO_SIDED|95.0|-0.049|0.094||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.094|-0.049|0.535
74074673|NCT02087904|147701869|SUPERIORITY||LS Mean Difference|-0.006||||0.866|TWO_SIDED|95.0|-0.076|0.064||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.064|-0.076|0.866
74074674|NCT02087904|147701869|SUPERIORITY||LS Mean Difference|-0.012||||0.413|TWO_SIDED|95.0|-0.041|0.017||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.017|-0.041|0.413
74074675|NCT02087904|147701869|SUPERIORITY||LS Mean Difference|0.012||||0.445|TWO_SIDED|95.0|-0.018|0.042||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.042|-0.018|0.445
74074676|NCT02087904|147701869|SUPERIORITY||LS Mean Difference|-0.003||||0.835|TWO_SIDED|95.0|-0.032|0.026||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.026|-0.032|0.835
74074677|NCT02087904|147701870|SUPERIORITY||Response Rate Difference|7.0||||0.311|TWO_SIDED|95.0|-7.3|21.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||21.4|-7.3|0.311
74074678|NCT02087904|147701870|SUPERIORITY||Response Rate Difference|5.5||||0.435|TWO_SIDED|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||19.9|-8.9|0.435
74074679|NCT02087904|147701870|SUPERIORITY||Response Rate Difference|5.5||||0.435|TWO_SIDED|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||19.9|-8.9|0.435
74074680|NCT02087904|147701871|SUPERIORITY||Response Rate Difference|2.4||||0.744|TWO_SIDED|95.0|-11.9|16.8||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||16.8|-11.9|0.744
74074681|NCT02087904|147701871|SUPERIORITY||Response Rate Difference|4.3||||0.581|TWO_SIDED|95.0|-10.1|18.7||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||18.7|-10.1|0.581
74074682|NCT02087904|147701871|SUPERIORITY||Response Rate Difference|10.4||||0.146|TWO_SIDED|95.0|-3.5|24.3||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||24.3|-3.5|0.146
74074683|NCT02087904|147701872|SUPERIORITY||Response Rate Difference|-1.3||||0.824|TWO_SIDED|95.0|-14.9|12.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||12.4|-14.9|0.824
74074684|NCT02087904|147701872|SUPERIORITY||Response Rate Difference|0.8||||0.964|TWO_SIDED|95.0|-12.8|14.5||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||14.5|-12.8|0.964
74074685|NCT02087904|147701872|SUPERIORITY||Response Rate Difference|2.1||||0.763|TWO_SIDED|95.0|-11.3|15.6||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||15.6|-11.3|0.763
74074686|NCT01382719|147701889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0215|STANDARD_DEVIATION|2.9|<|0.05|TWO_SIDED|95.0|0.0|1.0|||Van Elteren|||||1.0|0.0|<0.05
74074687|NCT01382719|147701889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0012|STANDARD_DEVIATION|0.0012|<|0.05|TWO_SIDED|95.0|0.0|0.06|||Van Elteren|||||0.06|0.00|<0.05
74074688|NCT01382719|147701890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0496|||<|0.05|||||||ANCOVA|||||||<0.05
74074689|NCT01382719|147701891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0079|||<|0.05|TWO_SIDED|95.0|0.0|1.0|||Van Elteren|||||1.00|0.00|<0.05
74074690|NCT01382719|147701892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0012|||<|0.05|||||||Van Elteren|||||||<0.05
74074691|NCT01382719|147701893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0013|||<|0.05|||||||Van Elteren|||||||<0.05
74074692|NCT01382719|147701894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1161|||<|0.05|||||||Van Elteren|||||||<0.05
74074693|NCT01382719|147701895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0133|||<|0.05|||||||ANCOVA|||||||<0.05
74074694|NCT01544127|147702012|SUPERIORITY||Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.19||0.054|TWO_SIDED|95.0|0.31|1.12||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|"MI-SI + TAU and MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the presence of suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."||1.12|0.31|.054
74074695|NCT01544127|147702012|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.26||0.12|TWO_SIDED|95.0|0.26|1.4||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI+TAU vs. TAU Alone||1.40|0.26|0.12
74074696|NCT01544127|147702012|SUPERIORITY||Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.22||0.08|TWO_SIDED|95.0|0.28|1.24||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI-R + TAU vs. TAU Alone||1.24|0.28|0.08
74074697|NCT01544127|147702013|SUPERIORITY||Beta|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.3|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||"MI-SI + TAU vs. MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence/absence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the severity of suicidal ideation among participants with suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."||||0.30
74074698|NCT01544127|147702013|SUPERIORITY||Beta|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI vs. TAU Alone||||0.23
74074699|NCT01544127|147702013|SUPERIORITY||Beta|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.46|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI-R vs. TAU Alone||||0.46
74074700|NCT01544127|147702014|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.65||0.96|TWO_SIDED|0.95|0.3|3.54||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI + TAU vs. TAU Alone||3.54|0.30|0.96
74074701|NCT01544127|147702014|SUPERIORITY||Odds Ratio (OR)|0.68|STANDARD_ERROR_OF_MEAN|0.38||0.5|TWO_SIDED|95.0|0.23|2.06||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI-R + TAU vs. TAU Alone||2.06|0.23|0.50
74074702|NCT01544127|147702015|SUPERIORITY||Cox Proportional Hazard|1.69|STANDARD_ERROR_OF_MEAN|0.91||0.31|TWO_SIDED|95.0|0.59|4.88||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI + TAU vs. TAU Alone||4.88|0.59|0.31
74074703|NCT01544127|147702015|SUPERIORITY||Cox Proportional Hazard|0.49|STANDARD_ERROR_OF_MEAN|0.39||0.24|TWO_SIDED|95.0|0.1|2.31||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI-R vs. TAU Alone||2.31|0.10|0.24
74074704|NCT01544127|147702015|SUPERIORITY||Cox Proportional Hazard|0.29|STANDARD_ERROR_OF_MEAN|0.23||0.1|TWO_SIDED|95.0|0.06|1.43||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||"MI-SI-R + TAU vs. MI-SI + TAU~Because the impact of MI-SI + TAU and MI-SI-R + TAU were in different directions when compared to TAU Alone, they were compared. For this analysis, the null hypothesis was that the revisions did not change the impact of MI-SI + TAU."||1.43|0.06|0.10
74074705|NCT02794974|147702016|SUPERIORITY|||||||0.236|||||||Fisher Exact|||||||0.236
74074706|NCT02794974|147702017|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
74074707|NCT02794974|147702018|SUPERIORITY||Odds Ratio|4.5||||0.209|TWO_SIDED|95.0|0.63|32.2|||Odds Ratio|||||32.2|0.63|0.209
74074708|NCT02794974|147702019|SUPERIORITY||Odds Ratio|2.5||||0.44|TWO_SIDED|95.0|0.49|12.77|||Odds Ratio|||||12.77|0.49|0.44
74074709|NCT02794974|147702020|SUPERIORITY||Odds Ratio|1.88||||0.695|TWO_SIDED|95.0|0.37|9.45|||Odds Ratio|||||9.45|0.37|0.695
74074710|NCT00533273|147702021|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<.001
74074711|NCT00533273|147702022|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<.001
74074712|NCT00533273|147702023|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
74074713|NCT00533273|147702024|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
74074714|NCT00533273|147702026|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|||||||.014
74074715|NCT00533273|147702027|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
74074716|NCT00533273|147702028|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
74074717|NCT00533273|147702029|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
74074718|NCT02870920|147702039|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.07|TWO_SIDED|90.0|0.54|0.97|||Log Rank|||||0.97|0.54|0.07
74074719|NCT02870920|147702040|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.97|TWO_SIDED|90.0|0.76|1.34|||Log Rank|||||1.34|0.76|0.97
73884669|NCT02491684|147303002|SUPERIORITY_OR_OTHER||LS Mean difference|11.69||||0.211|TWO_SIDED|95.0|-6.76|30.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||30.14|-6.76|0.211
74074720|NCT00454909|147702080|SUPERIORITY||Difference in percentage|11.2|||||TWO_SIDED|95.0|3.87|19.18||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup A (hSBA-MenA) antibody titers ≥ 1:8 one month after vaccination.||19.18|3.87|
74074721|NCT00454909|147702080|SUPERIORITY||Difference in percentage|-2.77|||||TWO_SIDED|95.0|-5.08|0.4||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup C (hSBA-MenC) antibody titers ≥ 1:8 one month after vaccination.||0.40|-5.08|
74074722|NCT00454909|147702080|SUPERIORITY||Difference in percentage|14.93|||||TWO_SIDED|95.0|8.24|22.71||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup W-135 (hSBA-MenW -135) antibody titers ≥ 1:8 one month after vaccination.||22.71|8.24|
74074723|NCT00454909|147702080|SUPERIORITY||Difference in percentage|13.4|||||TWO_SIDED|95.0|7.9|20.1||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup Y (hSBA-MenY) antibody titers ≥ 1:8 one month after vaccination.||20.10|7.90|
74074724|NCT02996682|147702090|SUPERIORITY||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.||||<0.001
74074725|NCT02996682|147702090|SUPERIORITY||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.||||<0.001
74074726|NCT00624065|147702131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.968||||0.8822||95.0|0.63|1.49|||Regression, Logistic|||||1.49|0.63|0.8822
74074727|NCT00696020|147702133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.027||0.3791|TWO_SIDED|95.0|-0.029|0.076||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.076|-0.029|0.3791
74074728|NCT00696020|147702133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.027||0.2133|TWO_SIDED|95.0|-0.019|0.085||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.085|-0.019|0.2133
74074729|NCT00696020|147702133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.027||0.0337|TWO_SIDED|95.0|0.004|0.11||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.110|0.004|0.0337
74074730|NCT00696020|147702134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.026||0.1163|TWO_SIDED|95.0|-0.01|0.093||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.093|-0.010|0.1163
74074731|NCT00696020|147702134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.026||0.0224|TWO_SIDED|95.0|0.009|0.111||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.111|0.009|0.0224
74074732|NCT00696020|147702134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.026||0.038|TWO_SIDED|95.0|0.003|0.107||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.107|0.003|0.0380
74074733|NCT00696020|147702135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.047||0.9573|TWO_SIDED|95.0|-0.089|0.094|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.094|-0.089|0.9573
74074734|NCT00696020|147702135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.046||0.0321|TWO_SIDED|95.0|0.009|0.189|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.189|0.009|0.0321
74074735|NCT00696020|147702135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.047||0.0125|TWO_SIDED|95.0|0.025|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.209|0.025|0.0125
74074736|NCT00696020|147702136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.03||0.0052|TWO_SIDED|95.0|0.026|0.145|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.145|0.026|0.0052
74074737|NCT00696020|147702136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.03||0.0086|TWO_SIDED|95.0|0.02|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.138|0.020|0.0086
74074738|NCT00696020|147702136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.066|0.185|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.185|0.066|<0.0001
74074739|NCT00696020|147702137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|0.056||0.0384|TWO_SIDED|95.0|0.006|0.225|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.225|0.006|0.0384
74074740|NCT00696020|147702137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.055||0.0009|TWO_SIDED|95.0|0.076|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.292|0.076|0.0009
74074741|NCT00696020|147702137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|0.13|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.349|0.130|<0.0001
74074742|NCT00696020|147702138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.357|STANDARD_ERROR_OF_MEAN|6.76||0.001|TWO_SIDED|95.0|9.057|35.657|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||35.657|9.057|0.0010
74074743|NCT00696020|147702138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.769|STANDARD_ERROR_OF_MEAN|6.687||0.0053|TWO_SIDED|95.0|5.613|31.924|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||31.924|5.613|0.0053
74074744|NCT00696020|147702138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.954|STANDARD_ERROR_OF_MEAN|6.805|<|0.0001|TWO_SIDED|95.0|13.565|40.343|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||40.343|13.565|<0.0001
74074745|NCT00696020|147702139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.031||0.0048|TWO_SIDED|95.0|0.027|0.149|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.149|0.027|0.0048
74074746|NCT00696020|147702139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.031||0.0056|TWO_SIDED|95.0|0.025|0.146|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.146|0.025|0.0056
74074747|NCT00696020|147702139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.066|0.189|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.189|0.066|<0.0001
74074748|NCT00696020|147702140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.056||0.0332|TWO_SIDED|95.0|0.01|0.23|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.230|0.010|0.0332
74074749|NCT00696020|147702140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.055||0.0011|TWO_SIDED|95.0|0.074|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.292|0.074|0.0011
74074750|NCT00696020|147702140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|0.128|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.349|0.128|<0.0001
74074751|NCT00696020|147702141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.867|STANDARD_ERROR_OF_MEAN|6.813||0.0009|TWO_SIDED|95.0|9.462|36.272|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||36.272|9.462|0.0009
74074752|NCT00696020|147702141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.743|STANDARD_ERROR_OF_MEAN|6.739||0.0036|TWO_SIDED|95.0|6.484|33.002|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||33.002|6.484|0.0036
74074753|NCT00696020|147702141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.793|STANDARD_ERROR_OF_MEAN|6.859|<|0.0001|TWO_SIDED|95.0|14.298|41.287|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||41.287|14.298|<0.0001
74074754|NCT00696020|147702142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.033||0.0079|TWO_SIDED|95.0|0.023|0.152|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.152|0.023|0.0079
74074755|NCT00696020|147702142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.032||0.012|TWO_SIDED|95.0|0.018|0.146|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.146|0.018|0.0120
74074756|NCT00696020|147702142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.08|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.209|0.080|<0.0001
74074757|NCT00696020|147702143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.06||0.0296|TWO_SIDED|95.0|0.013|0.249|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.249|0.013|0.0296
74074758|NCT00696020|147702143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.059||0.0007|TWO_SIDED|95.0|0.087|0.32|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.320|0.087|0.0007
74074759|NCT00696020|147702143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|0.147|0.383|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.383|0.147|<0.0001
74074760|NCT00696020|147702144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.414|STANDARD_ERROR_OF_MEAN|7.057||0.001|TWO_SIDED|95.0|9.529|37.3|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||37.300|9.529|0.0010
74074761|NCT00696020|147702144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.695|STANDARD_ERROR_OF_MEAN|6.981||0.0078|TWO_SIDED|95.0|4.961|32.43|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||32.430|4.961|0.0078
74074762|NCT00696020|147702144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.357|STANDARD_ERROR_OF_MEAN|7.105|<|0.0001|TWO_SIDED|95.0|15.379|43.335|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||43.335|15.379|<0.0001
74074763|NCT00696020|147702146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.048||0.3517|TWO_SIDED|95.0|-0.049|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.138|-0.049|0.3517
74074764|NCT00696020|147702146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.048||0.3171|TWO_SIDED|95.0|-0.046|0.143|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.143|-0.046|0.3171
74074765|NCT00696020|147702146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.048||0.4654|TWO_SIDED|95.0|-0.06|0.13|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.130|-0.060|0.4654
74074766|NCT00696020|147702147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.106|STANDARD_ERROR_OF_MEAN|7.704||0.0899|TWO_SIDED|95.0|-2.055|28.267|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||28.267|-2.055|0.0899
74074767|NCT00696020|147702147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.817|STANDARD_ERROR_OF_MEAN|7.759||0.0111|TWO_SIDED|95.0|4.549|35.084|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||35.084|4.549|0.0111
74074768|NCT00696020|147702147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.893|STANDARD_ERROR_OF_MEAN|7.844||0.0166|TWO_SIDED|95.0|3.458|34.329|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||34.329|3.458|0.0166
74074769|NCT01387022|147702160|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
74074770|NCT01387022|147702161|SUPERIORITY_OR_OTHER|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
74074771|NCT01387022|147702163|SUPERIORITY_OR_OTHER|||||||0.267|||||||Fisher Exact|||||||0.267
73884670|NCT02491684|147303002|SUPERIORITY_OR_OTHER||LS Mean difference|11.19||||0.125|TWO_SIDED|95.0|-3.18|25.56|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||25.56|-3.18|0.125
73884671|NCT02491684|147303002|SUPERIORITY_OR_OTHER||LS Mean difference|11.14||||0.277|TWO_SIDED|95.0|-9.08|31.36|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||31.36|-9.08|0.277
74074772|NCT01371786|147702172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.92|||||TWO_SIDED|95.0|-21.76|-4.09||No formal statistical testing was conducted. Only descriptive statistics were calculated and presented.|||Difference calculated as Mometasone minus Ciclesonide|No formal null hypothesis was stated or tested.Descriptive statistics only were calculated and presented. The sample size was determined outside of statistical considerations. The sample size of 10 subjects was sufficient to provide approximately 80% power to detect a difference of 25% between the two treatment groups in the percentage of nasal deposition approximately 2 minutes post dose, assuming a two-sided test evaluated at a significance level of 0.05, with a SD of the difference of 23.17%.||-4.09|-21.76|
74074773|NCT02511782|147702177|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
74074774|NCT02511782|147702178|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
74074775|NCT01376167|147702191|SUPERIORITY||Hazard Ratio (HR)|0.299|||<|0.001|TWO_SIDED|95.0|0.222|0.404||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.404|0.222|<0.001
74074776|NCT01376167|147702191|SUPERIORITY||Hazard Ratio (HR)|0.262|||<|0.001|TWO_SIDED|95.0|0.178|0.387||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.387|0.178|<0.001
74074777|NCT01376167|147702191|SUPERIORITY||Odds Ratio (OR)|0.241|||<|0.001|TWO_SIDED|95.0|0.152|0.382||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios \< 1 suggested a smaller chance of recurrence compared to CQ Only.|||0.382|0.152|<0.001
73884672|NCT02491684|147303002|SUPERIORITY_OR_OTHER||LS Mean difference|17.13||||0.161|TWO_SIDED|95.0|-6.92|41.18|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||41.18|-6.92|0.161
73884673|NCT02491684|147303003|SUPERIORITY_OR_OTHER||LS Mean difference|0.06||||0.287|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||0.16|-0.05|0.287
73884674|NCT02491684|147303003|SUPERIORITY_OR_OTHER||LS Mean difference|0.04||||0.457|TWO_SIDED|95.0|-0.06|0.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||0.14|-0.06|0.457
73884675|NCT02491684|147303003|SUPERIORITY_OR_OTHER||LS Mean difference|0.05||||0.315|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||0.16|-0.05|0.315
73884676|NCT02491684|147303003|SUPERIORITY_OR_OTHER||LS Mean difference|0.09||||0.134|TWO_SIDED|95.0|-0.03|0.22|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||0.22|-0.03|0.134
73884677|NCT02559622|147303023|SUPERIORITY||Least Square (LS) mean difference|1.17||||0.223|TWO_SIDED|95.0|-0.72|3.06|||ANCOVA|||||3.06|-0.72|0.2230
74074778|NCT01376167|147702191|SUPERIORITY||Odds Ratio (OR)|0.198|||<|0.001|TWO_SIDED|95.0|0.117|0.335||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios \< 1 suggested a smaller chance of recurrence compared to CQ Only.|||0.335|0.117|<0.001
74074779|NCT01376167|147702192|SUPERIORITY||Hazard Ratio (HR)|0.271|||<|0.001|TWO_SIDED|95.0|0.195|0.376||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.376|0.195|<0.001
74074780|NCT01376167|147702192|SUPERIORITY||Hazard Ratio (HR)|0.255|||<|0.001|TWO_SIDED|95.0|0.167|0.39||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.390|0.167|<0.001
74074781|NCT04320849|147702274|OTHER||Slope|0.0675|||||ONE_SIDED|90.0||0.106||||||"The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the extravenous region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.106||
74074782|NCT04320849|147702275|OTHER||Slope|0.199|||||ONE_SIDED|90.0||0.397||||||"The following set of hypotheses will be used to evaluate the relationship between lead stiffness and curvature in the intracardiac region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.397||
74074783|NCT04320849|147702276|OTHER||Slope|-0.015|||||ONE_SIDED|90.0||0.0123||||||"The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the connector region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.0123||
74074784|NCT00705536|147702376|SUPERIORITY_OR_OTHER|||||||0.0006||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0006
73884678|NCT00468169|147303081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1225||||||Log-rank test comparing PFS between two treatment arms|Log Rank|||||||0.1225
74074785|NCT00705536|147702376|SUPERIORITY_OR_OTHER|||||||0.0002||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0002
73884679|NCT02183675|147303103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|108.39|STANDARD_ERROR_OF_MEAN|1.094|||TWO_SIDED|90.0|93.081|126.225|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||126.225|93.081|
73884680|NCT02183675|147303103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|114.86|STANDARD_ERROR_OF_MEAN|1.097|||TWO_SIDED|90.0|98.216|134.326|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||134.326|98.216|
73884681|NCT02183675|147303104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|97.53|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|90.43|105.19|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||105.19|90.43|
73884682|NCT02183675|147303104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|102.04|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|96.94|107.4|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||107.40|96.94|
74074786|NCT00705536|147702377|SUPERIORITY_OR_OTHER|||||||0.0003||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0003
74074787|NCT00705536|147702377|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
74074788|NCT00705536|147702378|SUPERIORITY_OR_OTHER|||||||0.0059||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0059
74074789|NCT00705536|147702378|SUPERIORITY_OR_OTHER|||||||0.0105||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0105
74074790|NCT00705536|147702379|SUPERIORITY_OR_OTHER|||||||0.0002||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0002
74074791|NCT00705536|147702379|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
74074792|NCT00705536|147702380|SUPERIORITY_OR_OTHER|||||||0.3019||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.3019
74074793|NCT00705536|147702381|SUPERIORITY_OR_OTHER|||||||0.0401||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0401
74074794|NCT00705536|147702381|SUPERIORITY_OR_OTHER|||||||0.0004||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0004
74074795|NCT00705536|147702382|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog +rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
74074796|NCT00705536|147702382|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
74074797|NCT00705536|147702384|SUPERIORITY_OR_OTHER|||||||0.5589||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.5589
74074798|NCT00705536|147702384|SUPERIORITY_OR_OTHER|||||||0.0067||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0067
74074799|NCT02289963|147702395|SUPERIORITY||Least Square (LS) Mean Difference|-63.4|||<|0.0001|TWO_SIDED|95.0|-71.6|-55.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/ Up to 150 mg Q2W vs. Placebo Q2W|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-55.2|-71.6|<0.0001
74074800|NCT02289963|147702396|SUPERIORITY||LS Mean Difference|-66.2|||<|0.0001|TWO_SIDED|95.0|-73.9|-58.4||Threshold for significance was at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-58.4|-73.9|<0.0001
74074801|NCT02289963|147702397|SUPERIORITY||LS Mean Difference|-62.5|||<|0.0001|TWO_SIDED|95.0|-68.8|-56.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-56.3|-68.8|<0.0001
74074802|NCT02289963|147702398|SUPERIORITY||LS Mean Difference|-63.1|||<|0.0001|TWO_SIDED|95.0|-69.2|-57.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-57.0|-69.2|<0.0001
74074803|NCT02289963|147702399|SUPERIORITY||LS Mean Difference|-46.3|||<|0.0001|TWO_SIDED|95.0|-53.0|-39.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.7|-53.0|<0.0001
74074804|NCT02289963|147702400|SUPERIORITY||LS Mean Difference|-49.2|||<|0.0001|TWO_SIDED|95.0|-55.3|-43.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.1|-55.3|<0.0001
73884683|NCT02183675|147303105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|104.8|STANDARD_ERROR_OF_MEAN|1.016|||TWO_SIDED|90.0|101.949|107.734|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||107.734|101.949|
73884684|NCT02183675|147303106|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|103.95|STANDARD_ERROR_OF_MEAN|1.017|||TWO_SIDED|90.0|101.023|106.964|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||106.964|101.023|
73884685|NCT02183675|147303107|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|102.49|STANDARD_ERROR_OF_MEAN|1.014|||TWO_SIDED|90.0|100.167|104.867|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||104.867|100.167|
73884686|NCT02183675|147303108|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|105.35|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|90.0|99.23|111.847|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||111.847|99.230|
74074805|NCT02289963|147702401|SUPERIORITY||LS Mean Difference|-51.5|||<|0.0001|TWO_SIDED|95.0|-58.4|-44.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.6|-58.4|<0.0001
74074806|NCT02289963|147702402|SUPERIORITY||LS Mean Difference|-54.2|||<|0.0001|TWO_SIDED|95.0|-60.6|-47.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.8|-60.6|<0.0001
74074807|NCT02289963|147702403|SUPERIORITY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|95.0|-40.3|-30.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.1|-40.3|<0.0001
74074808|NCT02289963|147702404|SUPERIORITY||LS Mean Difference|-46.1|||<|0.0001|TWO_SIDED|95.0|-51.2|-41.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.0|-51.2|<0.0001
74074809|NCT02289963|147702405|SUPERIORITY||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-56.4|-46.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-46.1|-56.4|<0.0001
74074810|NCT02289963|147702406|SUPERIORITY||LS Mean Difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-39.7|-31.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant.||-31.9|-39.7|<0.0001
74074811|NCT02289963|147702407|SUPERIORITY||Odds Ratio (OR)|46.9|||<|0.0001|TWO_SIDED|95.0|18.4|119.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||119.4|18.4|<0.0001
74074812|NCT02289963|147702408|SUPERIORITY||Odds Ratio (OR)|70.0|||<|0.0001|TWO_SIDED|95.0|23.3|210.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||210.8|23.3|<0.0001
73884687|NCT02183675|147303109|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|103.39|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|98.73|108.28|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||108.280|98.730|
74074813|NCT02289963|147702409|SUPERIORITY||Adjusted Mean Difference|-33.611|||<|0.0001|TWO_SIDED|95.0|-41.883|-25.338||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.338|-41.883|<0.0001
74074814|NCT02289963|147702410|SUPERIORITY||LS Mean Difference|7.5||||0.0029|TWO_SIDED|95.0|2.6|12.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.4|2.6|0.0029
74074815|NCT02289963|147702411|SUPERIORITY||LS Mean Difference|-4.515||||0.311|TWO_SIDED|95.0|-13.25|4.219||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.219|-13.250|0.3110
74074816|NCT00549718|147702420|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
74074817|NCT00549718|147702421|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
74074818|NCT00722124|147702479|SUPERIORITY_OR_OTHER|||||||0.615||95.0|||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.||||0.615
74074819|NCT00722124|147702479|SUPERIORITY_OR_OTHER|||||||0.826||95.0|||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.||||0.826
74074820|NCT00581139|147702480|SUPERIORITY|||||||0.02|||||||ANOVA|||||||.02
74074821|NCT00581139|147702482|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
74074822|NCT00581139|147702483|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
74074823|NCT00581139|147702484|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
74074824|NCT00581139|147702485|SUPERIORITY|||||||0.02|||||||ANOVA|||||||.02
74074825|NCT00581139|147702486|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
74074826|NCT00581139|147702487|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
74074827|NCT01136382|147702495|SUPERIORITY_OR_OTHER||LS mean difference|13.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|7.5|19.7||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p\<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||19.7|7.5|<0.0001
73884688|NCT01614249|147303120|SUPERIORITY_OR_OTHER||Slope|1.01|STANDARD_ERROR_OF_MEAN|0.8||0.21|TWO_SIDED|95.0|-0.58|2.6||The p-value was adjusted for baseline variations in the analysis of covariance (ANCOVA) regression model. The significance level was set at p-value less than 0.05.|ANCOVA|In ANCOVA, fish oil group was main effect, participant baseline variables were covariates and presence of interaction between covariates was tested.||Null hypothesis: There is no difference in the magnitude of change in BDI-II scores between HIV-seropositive pregnant women on fish oil omega-3 EPA-rich supplements and the control group on soybean oil soft gels. A sample size of 91 women per arm gave an 85% power to detect as statistically significant at 5% level, a true difference of 4 scores in the mean depressive symptom scores between the two arms assuming a within group standard deviation of nine in depressive symptom scores.||2.60|-0.58|0.21
73884689|NCT02761330|147303143|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.016
73884690|NCT02761330|147303143|OTHER|||||||0.012||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.012
73884691|NCT02761330|147303143|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.||||0.031
73884692|NCT02761330|147303143|OTHER|||||||0.203||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.||||0.203
73884693|NCT02761330|147303143|OTHER|||||||0.008||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Motor Praxis Task (MP) reaction time.||||0.008
74074828|NCT01136382|147702496|SUPERIORITY_OR_OTHER||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.022||0.0047|TWO_SIDED|95.0|0.02|0.11||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p\<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.11|0.02|0.0047
73884694|NCT02761330|147303143|OTHER|||||||0.496||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Motor Praxis Task (MP) reaction time.||||0.496
74074829|NCT01136382|147702497|SUPERIORITY_OR_OTHER||LS mean difference|10.8|STANDARD_ERROR_OF_MEAN|3.0||0.0004|TWO_SIDED|95.0|4.9|16.7|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||16.7|4.9|0.0004
74074830|NCT01136382|147702498|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0673|TWO_SIDED|95.0|0.0|0.08|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.08|0.00|0.0673
74074831|NCT01136382|147702499|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.044||0.0216|TWO_SIDED|95.0|0.01|0.19|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.19|0.01|0.0216
74074832|NCT01136382|147702500|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0004|TWO_SIDED|95.0|-0.31|-0.09||Analysis for change in daytime asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.09|-0.31|0.0004
74074833|NCT01136382|147702500|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0015|TWO_SIDED|95.0|-0.55|-0.13||Analysis for change in total asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.13|-0.55|0.0015
74074834|NCT01136382|147702501|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0079|TWO_SIDED|95.0|-0.26|-0.04|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.04|-0.26|0.0079
74074835|NCT01136382|147702502|SUPERIORITY_OR_OTHER||LS mean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.78||0.0095|TWO_SIDED|95.0|-8.2|-1.1||Analysis for change in nighttime awakenings from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-1.1|-8.2|0.0095
74074836|NCT01136382|147702502|SUPERIORITY_OR_OTHER||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|1.15||0.0007|TWO_SIDED|95.0|-6.2|-1.7||Analysis for change in nighttime awakenings with reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-1.7|-6.2|0.0007
74074837|NCT01136382|147702503|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07||0.0001|TWO_SIDED|95.0|-0.4|-0.1||Analysis for change in daytime reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.1|-0.4|0.0001
74074838|NCT01136382|147702503|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.7|-0.2||Analysis for change in total reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.2|-0.7|<0.0001
74074839|NCT01136382|147702504|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.1|-0.3|<0.0001
74074840|NCT01136382|147702505|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Log Rank|||||||0.0004
74074841|NCT00963482|147702510|SUPERIORITY_OR_OTHER||||||=|0.111||95.0||||not adjusted for multiple comparisons due to only two groups p\<.05, two-tailed|Chi-squared|||"H0: EG is equal in smoking quit rates compared to CG. H1: EG is superior in smoking quit rates compared to CG"||||=.111
74074842|NCT02653664|147702512|SUPERIORITY|||||||0.39||||||Statistical significance was set at p=.05|ANOVA|||Based on our prior work comparing similar interventions, assuming decreases in average pain intensity of 0.3 points (on a 0-10 scale) for ED, between 0.8 to 1.4 points for HYP, and between 0.6 to 1 for MM, with standard deviations (SD) ranging from 0.15 to 1, significance level of 0.05, and using ANOVA as the statistical method, we calculated that 80 participants per arm at immediate post-treatment would provide at least 80% power to detect between-groups differences as specified.||||.39
74074843|NCT02653664|147702513|SUPERIORITY|||||||0.05||||||Statistical significance was set at p=.05.|ANOVA|||||||.05
74074844|NCT02653664|147702514|SUPERIORITY||||||<|0.001||||||Statistical significance was set at p= .05|ANOVA|||||||<.001
74074845|NCT01045096|147702532|SUPERIORITY_OR_OTHER|||||||0.809||90.0|||||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An analysis of variance with covariates (ANCOVA) model with weight as a covariate and regimen as a factor were fitted to Tmax. Pairwise comparisons between regimens were conducted.||||0.809
74074846|NCT01045096|147702533|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.2|||||TWO_SIDED|90.0|0.66|2.183|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||2.183|0.660|
73884695|NCT02761330|147303143|OTHER|||||||0.844||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.||||0.844
73884696|NCT02761330|147303143|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.||||0.016
74074847|NCT01045096|147702533|SUPERIORITY_OR_OTHER||Dose proportionality Point Estimate|1.06|||||TWO_SIDED|90.0|0.463|2.427|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||2.427|0.463|
74074848|NCT01045096|147702533|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|0.88|||||TWO_SIDED|90.0|0.493|1.579|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||1.579|0.493|
74074849|NCT01045096|147702534|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.13|||||TWO_SIDED|90.0|0.693|1.848|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||1.848|0.693|
73884697|NCT02761330|147303143|OTHER|||||||0.062||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Abstract Matching task (AM) reaction time.||||0.062
74074850|NCT01045096|147702534|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.15|||||TWO_SIDED|90.0|0.584|2.276|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||2.276|0.584|
74074851|NCT01045096|147702534|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.02|||||TWO_SIDED|90.0|0.632|1.642|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||1.642|0.632|
74074852|NCT01045096|147702535|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.06|||||TWO_SIDED|90.0|0.692|1.636|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||1.636|0.692|
74074853|NCT01045096|147702535|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.26|||||TWO_SIDED|90.0|0.691|2.314|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||2.314|0.691|
74074854|NCT01045096|147702535|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.19|||||TWO_SIDED|95.0|0.777|1.817|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||1.817|0.777|
73884698|NCT02761330|147303143|OTHER|||||||0.039||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Abstract Matching task (AM) reaction time.||||0.039
73884699|NCT02761330|147303144|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Psychomotor Vigilance Task (PVT) reaction time.||||0.016
73884700|NCT02761330|147303144|OTHER|||||||0.039||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.039
73884701|NCT02761330|147303144|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.||||0.031
73884702|NCT02761330|147303144|OTHER|||||||1||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.||||1.0
73884703|NCT02761330|147303144|OTHER|||||||0.195||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Motor Praxis task (MP) reaction time.||||0.195
73884704|NCT02761330|147303144|OTHER|||||||0.57||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Motor Praxis task (MP) reaction time.||||0.570
73884705|NCT02761330|147303144|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.||||0.031
73884706|NCT02761330|147303144|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.||||0.016
74074855|NCT00324168|147702549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009||||0.82|TWO_SIDED|95.0|-0.085|0.068|||Regression, Linear|Adjusted for enrollment BSCVA||||0.068|-0.085|0.82
74074856|NCT00324168|147702550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.4|TWO_SIDED|95.0|-0.09|0.15|||Regression, Linear|||||0.15|-0.09|0.40
74074857|NCT00324168|147702551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.873|TWO_SIDED|95.0|-0.07|0.08|||Regression, Linear|||||0.08|-0.07|0.873
74074858|NCT00324168|147702552|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.44|TWO_SIDED|95.0|0.76|1.12|||Regression, Cox|||||1.12|0.76|0.44
74074859|NCT00324168|147702553|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||||||>0.99
73884707|NCT02761330|147303144|OTHER|||||||1||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Abstract Matching (AM) task reaction time.||||1.00
73884708|NCT02761330|147303144|OTHER|||||||0.109||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Abstract Matching (AM) task reaction time.||||0.109
73884709|NCT02761330|147303152|OTHER|||||||0.301|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.301
73884710|NCT02761330|147303152|OTHER|||||||0.301|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.301
73884711|NCT02761330|147303152|OTHER|||||||0.557|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.557
73884712|NCT02761330|147303153|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.910
73884713|NCT02761330|147303153|OTHER|||||||0.734|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.734
73884714|NCT02761330|147303153|OTHER|||||||0.322|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.322
73884715|NCT02761330|147303154|OTHER|||||||0.164|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.164
74074860|NCT00324168|147702554|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.39|TWO_SIDED|95.0|-0.12|0.05|||Regression, Linear|||||0.05|-0.12|0.39
73884716|NCT02761330|147303154|OTHER|||||||0.039|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.039
73884717|NCT02761330|147303154|OTHER|||||||0.375|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.375
74074861|NCT00324168|147702555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.78||95.0|-0.09|0.07|||Regression, Linear|||||0.07|-0.09|0.78
73884718|NCT02761330|147303155|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.910
73884719|NCT02761330|147303155|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.910
73884720|NCT02761330|147303155|OTHER|||||||0.625|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.625
73884721|NCT02761330|147303156|OTHER|||||||0.129|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.129
73884722|NCT02761330|147303156|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.910
73884723|NCT02761330|147303156|OTHER|||||||0.625|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.625
73884724|NCT02761330|147303157|OTHER|||||||1|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||1.000
73884725|NCT02761330|147303157|OTHER|||||||0.496|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||0.496
73884726|NCT02761330|147303157|OTHER|||||||0.16|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||0.160
73884727|NCT02761330|147303158|OTHER|||||||0.008|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.008
73884728|NCT02761330|147303158|OTHER|||||||0.359|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.359
74074862|NCT00324168|147702556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.3|TWO_SIDED|95.0|-0.011|0.35|||Regression, Linear|||Nocardia spp||0.35|-.011|0.30
74074863|NCT00324168|147702556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.86||95.0|-0.12|0.1|||Regression, Linear|||Streptococcus pneumoniae||0.10|-0.12|0.86
74074864|NCT00324168|147702556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.65|TWO_SIDED|95.0|-0.34|0.55|||Regression, Linear|||Moraxella spp||0.55|-0.34|0.65
74074865|NCT00324168|147702556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.67|TWO_SIDED|95.0|-0.2|0.13|||Regression, Linear|||Pseudomonas aeruginosa||0.13|-0.20|0.67
74074866|NCT00324168|147702557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.33|TWO_SIDED|95.0|-0.08|0.25|||Regression, Linear|||\<20/40||0.25|-0.08|0.33
74074867|NCT00324168|147702557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.85|TWO_SIDED|95.0|-0.09|0.11|||Regression, Linear|||20/40 to 20/800||0.11|-0.09|0.85
73884729|NCT02761330|147303158|OTHER|||||||0.375|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.375
74074868|NCT00324168|147702557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.03|TWO_SIDED|95.0|-0.31|-0.02|||Regression, Linear|||CF or worse||-0.02|-0.31|0.03
74074869|NCT00324168|147702558|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.31|TWO_SIDED|95.0|-0.05|0.17|||Regression, Linear|||\>0-33%||0.17|-0.05|0.31
74074870|NCT00324168|147702558|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.94|TWO_SIDED|95.0|-0.13|0.14|||Regression, Linear|||\>33%-67%||0.14|-0.13|0.94
74074871|NCT00324168|147702558|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.07|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||\>67%-100%||0.01|-0.31|0.07
74074872|NCT00324168|147702559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.53|TWO_SIDED|95.0|-0.1|0.2|||Regression, Linear|||0-1.90 mm||0.20|-0.10|0.53
74074873|NCT00324168|147702559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.95|TWO_SIDED|95.0|-0.15|0.16|||Regression, Linear|||1.91-2.70 mm||0.16|-0.15|0.95
74074874|NCT00324168|147702559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.7|TWO_SIDED|95.0|-0.12|0.18|||Regression, Linear|||2.71-4.06 mm||0.18|-0.12|0.70
74074875|NCT00324168|147702559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.07|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||4.07-8.90 mm||0.01|-0.31|0.07
74074876|NCT03497897|147702562|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|Posterior geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.64|1.34|||Bayesian analysis|Bayesian mixed effect model with repeated measures|90% credible intervals are reported on the geometric means ratio|||1.34|0.64|
74074877|NCT03497897|147702562|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|P(Geometric Mean Ratio<1)|0.637|||||||||||Bayesian analysis|Bayesian mixed effect model with repeated measures|Posterior probability on geometric mean ratio is reported.|||||
74074878|NCT03497897|147702562|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|P(Geometric Mean Ratio<0.75)|0.171|||||||||||Bayesian analysis|Bayesian mixed effect model with repeated measures|Posterior probability on geometric mean ratio is reported.|||||
74074879|NCT00358449|147702575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.865|TWO_SIDED|95.0|0.04|5.44|||Regression, Logistic|||||5.44|0.04|0.865
74074880|NCT00358449|147702575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21||||0.19|TWO_SIDED|95.0|0.01|2.07|||Regression, Logistic|||||2.07|0.01|0.190
74074881|NCT00358449|147702578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128||||0.551|TWO_SIDED|95.0|-0.303|0.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.560|-0.303|0.551
74074882|NCT00358449|147702578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.593||95.0|-0.331|0.572|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.572|-0.331|0.593
74074883|NCT00358449|147702578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.334||||0.239|TWO_SIDED|95.0|-0.232|0.901|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.901|-0.232|0.239
74074884|NCT00358449|147702578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211||||0.488|TWO_SIDED|95.0|-0.401|0.823|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.823|-0.401|0.488
74074885|NCT00358449|147702579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.356||||0.139|TWO_SIDED|95.0|-0.121|0.833|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.833|-0.121|0.139
74074886|NCT00358449|147702579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.371||||0.145||95.0|-0.133|0.874|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.874|-0.133|0.145
74074887|NCT00358449|147702579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.433||||0.095|TWO_SIDED|95.0|-0.08|0.946|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.946|-0.080|0.095
74074888|NCT00358449|147702579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.343||||0.219|TWO_SIDED|95.0|-0.214|0.899|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.899|-0.214|0.219
74074889|NCT00358449|147702580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59||||0.832|TWO_SIDED|95.0|-13.47|16.65|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||16.65|-13.47|0.832
73884732|NCT01576341|147303212|OTHER||Incidence rate|0.019|||||TWO_SIDED||||||||Incidence rate is based on duration of treatment period (years)|||||
73884733|NCT03341299|147303214|SUPERIORITY||Ratio of geometric least square means|0.991||||0.7734|TWO_SIDED|95.0|0.932|1.05|||Mixed Models Analysis|||||1.05|0.932|0.7734
73884734|NCT03341299|147303215|SUPERIORITY||difference in LS means|-14.5||||0.719|TWO_SIDED|95.0|-94.38|65.38|||Mixed Models Analysis|||||65.38|-94.38|0.7190
73884735|NCT03589859|147303278|OTHER|This was a physiology study, not a treatment trial. The test was for a change in VOR gain.|||||<|0.001|||||||Mixed Models Analysis|||A linear mixed effects model was used to compare pre- and post-training VOR gains||||<0.001
73884736|NCT05010707|147303280|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||Time x treatment (month 0, and 1 month)||||0.005
73884737|NCT05010707|147303280|SUPERIORITY||Mean Difference (Final Values)|-225.3||||0.02|TWO_SIDED|95.0|-421.71|-28.79|||Mixed Models Analysis|||||-28.79|-421.71|0.02
73884738|NCT05010707|147303280|SUPERIORITY||Mean Difference (Final Values)|-250.6||||0.009|TWO_SIDED|95.0|-447.1|-54.19|||Mixed Models Analysis|||||-54.19|-447.10|0.009
73884739|NCT05010707|147303281|SUPERIORITY|||||||0.951|||||||Mixed Models Analysis|||Time x treatment (month 0 and month 1)||||0.951
73884740|NCT05010707|147303281|SUPERIORITY||Mean Difference (Final Values)|-1.6||||1|TWO_SIDED|95.0|-29.6|26.4|||Mixed Models Analysis||The mean difference is computed using the model based estimates rather than from the raw data.|||26.4|-29.6|1
73884741|NCT05010707|147303281|SUPERIORITY||Mean Difference (Final Values)|-7.1||||1|TWO_SIDED|95.0|-35.1|20.8|||Mixed Models Analysis||The mean difference is computed using the model based estimates rather than from the raw data.|||20.8|-35.1|1
73884742|NCT05010707|147303282|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||Time x treatment (month 0 and month 1)||||0.004
73884743|NCT05010707|147303282|SUPERIORITY||Mean Difference (Final Values)|-280.4||||0.005|TWO_SIDED|95.0|-487.3|-73.5|||Mixed Models Analysis|||||-73.5|-487.3|0.005
73884744|NCT05010707|147303282|SUPERIORITY||Mean Difference (Final Values)|-204.1||||0.054|TWO_SIDED|95.0|-411.1|2.8|||Mixed Models Analysis|||||2.8|-411.1|0.054
73884745|NCT00248625|147303286|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||||||0.19
73884746|NCT00248625|147303287|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||||||0.03
73884747|NCT00248625|147303288|SUPERIORITY_OR_OTHER|||||||0.21|||||||Pepe and Mori test of CIF difference|||||||0.21
73884748|NCT00248625|147303289|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Kruskal-Wallis|||||||0.053
73884749|NCT00248625|147303290|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Cochran-Armitage trend|||||||0.29
73884750|NCT00248625|147303291|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Cochran-Armitage trend|||||||0.74
73884751|NCT00248625|147303292|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Cochran-Armitage tren|||||||0.54
73884752|NCT00248625|147303293|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Chi-squared|||||||0.86
73884753|NCT02443688|147303295|OTHER|Single Group Difference from Placebo Mean Change from Baseline with 95% confidence interval (CI)|Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|95.0|-1.34|4.12|||ANOVA|||||4.12|-1.34|
73884754|NCT02443688|147303295|OTHER|Single Group Difference from Placebo Mean Change from Baseline with 95% CI|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|-3.78|1.64|||ANOVA|||||1.64|-3.78|
73884755|NCT02443688|147303295|SUPERIORITY|Difference from placebo of pooled arms (100mg CTX-4430 and 50mg CTX-4430) in change from baseline in ppFEV1 at Week 48.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.2||0.45|TWO_SIDED|95.0|-2.2|2.5||0.1 alpha level (2-sided) prespecified|ANOVA|||||2.50|-2.20|0.45
73884756|NCT02443688|147303296|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.57|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.22|2.02|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.02|1.22|
74074890|NCT00358449|147702580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.92||||0.622|TWO_SIDED|95.0|-12.01|19.84|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||19.84|-12.01|0.622
73884757|NCT02443688|147303296|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.46|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|1.13|1.89|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.89|1.13|
73884758|NCT02443688|147303296|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.56|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.21|2.01|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.01|1.21|
73884759|NCT02443688|147303296|OTHER|Pooled Group Rate with 95% CI|see Estimation Comment below|1.51|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|1.26|1.81|||||Estimated using negative binomial distribution unadjusted for multiple comparisons.|||1.81|1.26|
73884760|NCT02443688|147303297|OTHER|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.88|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.58|1.34|||Regression, Cox|||||1.34|0.58|
73884761|NCT02443688|147303297|OTHER|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.56|1.31|||Regression, Cox|||||1.31|0.56|
73884762|NCT02443688|147303297|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.87|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.61|1.25|||Regression, Cox|||||1.25|0.61|
74074891|NCT00358449|147702580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.83||||0.317|TWO_SIDED|95.0|-11.86|35.52|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||35.52|-11.86|0.317
74074892|NCT00358449|147702580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1||||0.246|TWO_SIDED|95.0|-10.91|41.11|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||41.11|-10.91|0.246
74074893|NCT00358449|147702581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.28||||0.046|TWO_SIDED|95.0|0.39|38.18|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||38.18|0.39|0.046
74074894|NCT00358449|147702581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.21||||0.16|TWO_SIDED|95.0|-5.83|34.25|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||34.25|-5.83|0.160
74074895|NCT00358449|147702581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.69||||0.078|TWO_SIDED|95.0|-2.1|37.48|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||37.48|-2.10|0.078
74074896|NCT00358449|147702581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.11||||0.055|TWO_SIDED|95.0|-0.51|42.74|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||42.74|-0.51|0.055
74074897|NCT00358449|147702582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.324||||0.241|TWO_SIDED|95.0|-0.226|0.873|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.873|-0.226|0.241
74074898|NCT00358449|147702582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.371|TWO_SIDED|95.0|-0.32|0.839|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.839|-0.320|0.371
74074899|NCT00358449|147702582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353||||0.291|TWO_SIDED|95.0|-0.317|1.023|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.023|-0.317|0.291
74074900|NCT00358449|147702582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176||||0.653|TWO_SIDED|95.0|-0.965|0.614|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.614|-0.965|0.653
74074901|NCT00358449|147702583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.06||||0.123|TWO_SIDED|95.0|-4.0|32.13|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||32.13|-4.00|0.123
74074902|NCT00358449|147702583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.62||||0.551|TWO_SIDED|95.0|-13.29|24.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||24.54|-13.29|0.551
74074903|NCT00358449|147702583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.04||||0.141|TWO_SIDED|95.0|-5.61|37.7|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||37.70|-5.61|0.141
74074904|NCT00358449|147702583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.42||||0.666|TWO_SIDED|95.0|-30.74|19.9|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||19.90|-30.74|0.666
74074905|NCT00358449|147702584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.572|TWO_SIDED|95.0|-0.224|0.4|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.400|-0.224|0.572
74074906|NCT00358449|147702584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.942|TWO_SIDED|95.0|-0.35|0.326|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.326|-0.350|0.942
74074907|NCT00358449|147702584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.96|TWO_SIDED|95.0|-0.188|0.197|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.197|-0.188|0.960
74074908|NCT00358449|147702584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.317|TWO_SIDED|95.0|-0.105|0.315|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.315|-0.105|0.317
74074909|NCT00358449|147702585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.666|TWO_SIDED|95.0|-6.39|4.12|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||4.12|-6.39|0.666
74074910|NCT00358449|147702585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16||||0.45|TWO_SIDED|95.0|-7.87|3.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||3.56|-7.87|0.450
74074911|NCT00358449|147702585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.215|TWO_SIDED|95.0|-12.0|2.81|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||2.81|-12.00|0.215
74074912|NCT00358449|147702585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.898|TWO_SIDED|95.0|-8.61|7.58|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||7.58|-8.61|0.898
74074913|NCT00358449|147702586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.762|TWO_SIDED|95.0|-0.217|0.294|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.294|-0.217|0.762
74074914|NCT00358449|147702586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159||||0.235|TWO_SIDED|95.0|-0.426|0.108|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.108|-0.426|0.235
74074915|NCT00358449|147702586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089||||0.607|TWO_SIDED|95.0|-0.259|0.436|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.436|-0.259|0.607
74074916|NCT00358449|147702586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068||||0.716|TWO_SIDED|95.0|-0.308|0.443|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.443|-0.308|0.716
74074917|NCT00358449|147702587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.691|TWO_SIDED|95.0|-0.365|0.545|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.545|-0.365|0.691
74074918|NCT00358449|147702587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.161||||0.5|TWO_SIDED|95.0|-0.639|0.317|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.317|-0.639|0.500
74074919|NCT00358449|147702587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.568|TWO_SIDED|95.0|-0.474|0.849|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.849|-0.474|0.568
74074920|NCT00358449|147702587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076||||0.832|TWO_SIDED|95.0|-0.643|0.794|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.794|-0.643|0.832
74074921|NCT00358449|147702588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.515|TWO_SIDED|95.0|-3.45|1.76|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||1.76|-3.45|0.515
74074922|NCT00358449|147702588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.496|TWO_SIDED|95.0|-1.74|3.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||3.54|-1.74|0.496
74074923|NCT00358449|147702588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.657|TWO_SIDED|95.0|-5.82|3.72|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||3.72|-5.82|0.657
74074924|NCT00358449|147702588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.691|TWO_SIDED|95.0|-6.11|4.09|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||4.09|-6.11|0.691
74074925|NCT00358449|147702589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.142|TWO_SIDED|95.0|-0.105|0.704|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.704|-0.105|0.142
74074926|NCT00358449|147702589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354||||0.115|TWO_SIDED|95.0|-0.09|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.798|-0.090|0.115
74074927|NCT00358449|147702589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.465|TWO_SIDED|95.0|-0.319|0.683|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.683|-0.319|0.465
74074928|NCT00358449|147702589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121||||0.649|TWO_SIDED|95.0|-0.417|0.66|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.660|-0.417|0.649
74074929|NCT00358449|147702590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.077|TWO_SIDED|95.0|-0.042|0.782|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.782|-0.042|0.077
74074930|NCT00358449|147702590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.356||||0.12|TWO_SIDED|95.0|-0.097|0.809|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.809|-0.097|0.120
74074931|NCT00358449|147702590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.345|TWO_SIDED|95.0|-0.326|0.906|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.906|-0.326|0.345
74074932|NCT00358449|147702590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128||||0.7|TWO_SIDED|95.0|-0.541|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.798|-0.541|0.700
74074933|NCT00358449|147702591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79||||0.609|TWO_SIDED|95.0|-8.79|5.22|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||5.22|-8.79|0.609
74074934|NCT00358449|147702591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||0.882|TWO_SIDED|95.0|-8.55|7.38|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||7.38|-8.55|0.882
74074935|NCT00358449|147702591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.595|TWO_SIDED|95.0|-7.68|4.47|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||4.47|-7.68|0.595
74074936|NCT00358449|147702591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.895|TWO_SIDED|95.0|-7.34|6.44|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||6.44|-7.34|0.895
74074937|NCT00358449|147702592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.513||||0.062|TWO_SIDED|95.0|-0.028|1.055|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||1.055|-0.028|0.062
74074938|NCT00358449|147702592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241||||0.425|TWO_SIDED|95.0|-0.369|0.852|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.852|-0.369|0.425
74074939|NCT00358449|147702592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.082|TWO_SIDED|95.0|-0.096|1.516|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.516|-0.096|0.082
74074940|NCT00358449|147702592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.564|TWO_SIDED|95.0|-0.631|1.132|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.132|-0.631|0.564
73884763|NCT02443688|147303303|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|0.84|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|0.49|1.44|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.44|0.49|
73884764|NCT02443688|147303303|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.28|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|0.84|1.96|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.96|0.84|
73884765|NCT02443688|147303303|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.61|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|1.07|2.42|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.42|1.07|
73884766|NCT02443688|147303303|OTHER|Group Rate with 95% CI|see Estimation Comment below|1.04|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.74|1.46|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.46|0.74|
73884767|NCT02443688|147303304|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.52|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|0.25|1.1|||Regression, Cox|||||1.10|0.25|
73884768|NCT02443688|147303304|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.62|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.3|1.27|||Regression, Cox|||||1.27|0.30|
73884769|NCT02443688|147303304|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.57|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.31|1.05|||Regression, Cox|||||1.05|0.31|
73884770|NCT03182374|147303310|SUPERIORITY||||||<|0.0001||||||ITT Population|t-test, 2 sided|||||||<0.0001
74074941|NCT00358449|147702593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45||||0.27|TWO_SIDED|95.0|-7.77|26.67|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||26.67|-7.77|0.270
74074942|NCT00358449|147702593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12||||0.664|TWO_SIDED|95.0|-15.11|23.36|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||23.36|-15.11|0.664
74074943|NCT00358449|147702593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57||||0.381|TWO_SIDED|95.0|-13.81|34.94|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||34.94|-13.81|0.381
74074944|NCT00358449|147702593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49||||0.672|TWO_SIDED|95.0|-20.87|31.86|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||31.86|-20.87|0.672
73884771|NCT03182374|147303311|SUPERIORITY||||||<|0.0001||||||PP Population|t-test, 2 sided|||||||<0.0001
73884772|NCT03182374|147303312|SUPERIORITY|||||||0.6655||||||PP Population|t-test, 2 sided|||||||0.6655
73884773|NCT03182374|147303313|SUPERIORITY||||||<|0.0001||||||PP Population|t-test, 2 sided|||||||<0.0001
73884774|NCT03182374|147303314|SUPERIORITY||||||<|0.05||||||PP population|t-test, 2 sided|||||||<0.05
73884775|NCT03182374|147303315|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73884776|NCT03085095|147303316|NON_INFERIORITY|The lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups was calculated with a noninferiority margin of -10%.|Treatment difference|7.9|||||TWO_SIDED|95.0|4.1|11.8|||||Treatment difference= Relugolix - Leuprolide acetate|Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of non-inferiority was conducted.||11.8|4.1|
73884777|NCT03085095|147303316|SUPERIORITY|If non-inferiority was demonstrated, superiority could be claimed if the lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups also excluded 0%. The p value was calculated post hoc.|||||<|0.0001|||||||t-test, 2 sided|Two-sided type I error of 0.05.||Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of superiority was conducted.||||< 0.0001
73884778|NCT03085095|147303317|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
73884779|NCT03085095|147303318|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
73884780|NCT03085095|147303319|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|Cochran-Mantel-Haenszel|||Alpha-protected statistical analysis.||||< 0.0001
73884781|NCT03085095|147303320|SUPERIORITY||Treatment difference|77.41|||<|0.0001|TWO_SIDED|95.0|73.98|80.83||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.|Treatment difference= Relugolix - Leuprolide acetate|Alpha-protected statistical analysis.||80.83|73.98|< 0.0001
73884782|NCT03085095|147303321|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
74074945|NCT00358449|147702594|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Cochran-Mantel-Haenszel|||||||0.400
73884783|NCT03085095|147303325|OTHER||Treatment difference|13.0|||||TWO_SIDED|95.0|6.9|19.1|||||Treatment difference= Relugolix - Leuprolide acetate|||19.1|6.9|
73884784|NCT03085095|147303327|OTHER||Treatment difference|-2.9|||||TWO_SIDED|95.0|-7.8|2.0|||||Treatment difference= Relugolix - Leuprolide acetate|||2.0|-7.8|
73884785|NCT00408317|147303343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.74|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CFA% values including sequence, period, and treatment group as fixed effects; participant identification (ID) as random effect.||||<0.0001
74074946|NCT00358449|147702594|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||Cochran-Mantel-Haenszel|||||||0.111
74074947|NCT00358449|147702595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3||||0.421|TWO_SIDED|95.0|-71.1|34.4|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12|||34.4|-71.1|0.421
74074948|NCT00358449|147702595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.633|TWO_SIDED|95.0|-44.6|40.5|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12|||40.5|-44.6|0.633
74074949|NCT00358449|147702595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3||||0.92|TWO_SIDED|95.0|-76.3|45.7|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24|||45.7|-76.3|0.920
74074950|NCT00358449|147702595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.8||||0.105|TWO_SIDED|95.0|-79.2|11.6|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24|||11.6|-79.2|0.105
74074951|NCT00358449|147702596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63||||0.747|TWO_SIDED|95.0|-20.68|15.41|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12|||15.41|-20.68|0.747
74074952|NCT00358449|147702596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.352|TWO_SIDED|95.0|-24.41|11.01|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12|||11.01|-24.41|0.352
74074953|NCT00358449|147702596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.25||||0.525|TWO_SIDED|95.0|-29.69|11.2|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 24|||11.20|-29.69|0.525
74074954|NCT00358449|147702596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.79||||0.071|TWO_SIDED|95.0|-35.21|-0.38|||Van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline at week 24|||-0.38|-35.21|0.071
74074955|NCT02163837|147702608|SUPERIORITY|the study was exploratory, the number of patients included was not calculated|||||<|0.05|||||||McNemar|||Mc Nemar symetry test for repeated measures and paired t-tests as appropriated||||<0.05
74074956|NCT01643707|147702609|SUPERIORITY|A chi-square test was performed to determine a difference between Phase 1 and Phase 2.|||||<|1e-05|||||||Chi-squared|||||||<0.00001
74074957|NCT01643707|147702610|EQUIVALENCE|Chi-Square test used to show any difference between Phase 1 and Phase 2|||||<|0.0001|||||||Chi-squared|||||||<0.0001
74074958|NCT01643707|147702611|EQUIVALENCE|Chi-Square test used to show any difference between Phase 1 and Phase 2|||||<|0.0001||||||This endpoint was covered in primary objective 2, so this analysis is the same as previously reported.|Chi-squared||||See Primary Objectives for additional details.|||<0.0001
74074959|NCT01389102|147702675|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74074960|NCT01389102|147702675|SUPERIORITY_OR_OTHER|||||||0.0099||95.0|||||ANCOVA|||||||0.0099
74074961|NCT01389102|147702675|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANCOVA|||||||0.0004
74074962|NCT01389102|147702676|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74074963|NCT01389102|147702676|SUPERIORITY_OR_OTHER|||||||0.0406||95.0|||||ANCOVA|||||||0.0406
74074964|NCT01389102|147702676|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
74074965|NCT01536405|147702715|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% confidence interval (CI) on the risk difference excluding a decrease \>= the prespecified criterion of 10 percentage points|Risk Difference (RD)|4.2|||<|0.001|TWO_SIDED|95.0|1.8|6.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||6.8|1.8|<0.001
74074966|NCT01536405|147702715|SUPERIORITY_OR_OTHER||Response rate|97.3|||<|0.001|TWO_SIDED|95.0|95.6|98.4|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>76%||98.4|95.6|<0.001
74074967|NCT01536405|147702716|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-2.2||||0.003|TWO_SIDED|95.0|-4.0|-0.6|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||-0.6|-4.0|0.003
74074968|NCT01536405|147702716|SUPERIORITY_OR_OTHER||Response rate|96.7|||<|0.001|TWO_SIDED|95.0|94.9|97.9|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||97.9|94.9|<0.001
74074969|NCT01536405|147702717|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|1.0|||<|0.001|TWO_SIDED|95.0|-0.7|2.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||2.8|-0.7|<0.001
74074970|NCT01536405|147702717|SUPERIORITY_OR_OTHER||Response rate|98.2|||<|0.001|TWO_SIDED|95.0|96.8|99.1|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||99.1|96.8|<0.001
74074971|NCT01536405|147702718|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-0.5|||<|0.001|TWO_SIDED|95.0|-1.8|0.7|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||0.7|-1.8|<0.001
74074972|NCT01536405|147702718|SUPERIORITY_OR_OTHER||Response rate|98.8|||<|0.001|TWO_SIDED|95.0|97.6|99.5|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||99.5|97.6|<0.001
74074973|NCT01536405|147702719|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.3|1.1|<0.001
74074974|NCT01536405|147702720|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.8|1.0|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.0|0.8|<0.001
74074975|NCT01536405|147702721|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.1|0.9|<0.001
74074976|NCT01536405|147702722|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.1|0.9|<0.001
74074977|NCT01536405|147702723|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-1.0|1.3|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||1.3|-1.0|<0.001
74074978|NCT02514122|147702731|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.009|TWO_SIDED|95.0|0.29|1.9||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|t-test, 2 sided||Score was lower in the Ketamine group.|||1.9|0.29|0.009
74074979|NCT02514122|147702732|SUPERIORITY||Risk Difference (RD)|0.37|||<|0.001|TWO_SIDED|95.0|0.18|0.54|||Fisher Exact|||||.54|.18|<0.001
74074980|NCT01472341|147702733|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.||||||0.24
74074981|NCT01472341|147702734|SUPERIORITY_OR_OTHER|||||||0.001|||||||Multivariate regression analysis|PI/I ratio was the response variable and other study parameters were independent variables.||||||0.001
74074982|NCT01472341|147702735|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.||||||<0.0001
73884786|NCT00408317|147303344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.68|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CNA% values including sequence, period, and treatment group as fixed effects, and participant ID as random effect.||||<0.0001
74074983|NCT01629381|147702803|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.3||||0.03|TWO_SIDED|95.0|-11.3|-0.4|||Fisher Exact|||||-0.4|-11.3|0.03
74074984|NCT01629381|147702805|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.3||||0.03|TWO_SIDED|95.0|-11.7|-0.1|||Fisher Exact|||||-0.1|-11.7|0.03
74074985|NCT01629381|147702806|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.0||||0.53|TWO_SIDED|95.0|-8.0|3.7|||Fisher Exact|||||3.7|-8.0|0.53
74074986|NCT01390844|147702813|SUPERIORITY_OR_OTHER||Difference in Percentage|34.63|||<|0.0001|TWO_SIDED|95.0|20.24|47.18|||Miettinen and Numinen|||Between-Group Comparison||47.18|20.24|<0.0001
74074987|NCT01390844|147702814|SUPERIORITY_OR_OTHER||Difference in Percentage|33.83||||0.0063|TWO_SIDED|95.0|10.15|52.18|||Miettinen and Numinen|||Between-Group Comparison||52.18|10.15|0.0063
74074988|NCT01390844|147702815|SUPERIORITY_OR_OTHER||Difference in Percentage|35.05|||<|0.0001|TWO_SIDED|95.0|20.51|47.72|||Miettinen and Numinen|||Between-Group Comparison||47.72|20.51|<0.0001
74074989|NCT01390844|147702816|SUPERIORITY_OR_OTHER||Difference in Percentage|33.18||||0.0086|TWO_SIDED|95.0|8.96|51.83|||Miettinen and Numinen|||Between-Group Comparison||51.83|8.96|0.0086
74074990|NCT01390844|147702817|SUPERIORITY_OR_OTHER||Difference in Percentage|29.08|||<|0.001|TWO_SIDED|95.0|15.26|42.22|||Miettinen and Nurminen|||Between-Group Comparison||42.22|15.26|<0.001
74074991|NCT01390844|147702818|SUPERIORITY_OR_OTHER||Difference in Percentage|36.13||||0.004|TWO_SIDED|95.0|12.12|55.01|||Mittienen and Nurminen|||Between-Group Comparison||55.01|12.12|0.004
74074992|NCT05093205|147702863|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 120 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 3).|Specified in comments|122.48|||||TWO_SIDED|90.0|106.96|140.25|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||140.25|106.96|
74074993|NCT05093205|147702863|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 200 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 5).|Specified in comments|143.83|||||TWO_SIDED|90.0|122.64|168.68|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||168.68|122.64|
74074994|NCT05093205|147702864|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 120 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 3).|Specified in comments|104.46|||||TWO_SIDED|90.0|92.56|117.89|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||117.89|92.56|
74074995|NCT05093205|147702864|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 200 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 5).|Specified in comments|92.77|||||TWO_SIDED|90.0|81.05|106.19|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||106.19|81.05|
74074996|NCT04185909|147702881|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
74074997|NCT00048581|147702899|SUPERIORITY_OR_OTHER||Est. Weighted. Diff: Day 169 ACR 20|30.8|||<|0.001|TWO_SIDED|95.0|20.6|41.1||The a priori threshold for statistical significance was 5%. ACR 20 RR at 6 mos for PLA was expected to be \~25%. A sample of 256 in the ABA arm and 128 in PLA arm will yield a 96% power to detect a difference of 20% in ACR 20 at 5% significance level.|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|The first coprimary endpoint efficacy analysis tested for differences in ACR 20 response rate (RR) between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving placebo plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||41.1|20.6|<0.001
74074998|NCT00048581|147702900|SUPERIORITY_OR_OTHER||Est. of Weighted Diff: Day 169 HAQ|24.0|||<|0.001|TWO_SIDED|95.0|13.8|34.2||If the ACR20 analysis was not significant (5% level), then the comparison for HAQ response was not undertaken. If ACR20 comparison was significant (5% level), then CMH Chi-square test compared HAQ response between groups (5% level).|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|All comparisons of changes from baseline and construction of confidence intervals for continuous measures were based on an ANCOVA model with treatment as the main factor and baseline value as covariate.|The two primary efficacy analyses tested first for differences in ACR 20 followed by testing HAQ response rates between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||34.2|13.8|<0.001
74074999|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 20|12.3||||0.001|TWO_SIDED|95.0|4.6|20.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||20.0|4.6|0.001
74075000|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 50|2.3||||0.001|TWO_SIDED|95.0|-0.8|5.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||5.5|-0.8|0.001
74075001|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 70|0.8||||0.784|TWO_SIDED|95.0|-1.3|2.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||2.9|-1.3|0.784
74075002|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 20|14.0||||0.005|TWO_SIDED|95.0|4.0|24.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||24.0|4.0|0.005
74075003|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 50|5.6||||0.06|TWO_SIDED|95.0|-0.2|11.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||11.4|-0.2|0.06
74075004|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 70|1.6||||0.473|TWO_SIDED|95.0|-1.8|4.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||4.9|-1.8|0.473
74075005|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 20|22.0|||<|0.001|TWO_SIDED|95.0|11.3|32.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||32.8|11.3|<0.001
74075006|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 50|6.5||||0.076|TWO_SIDED|95.0|-0.6|13.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||13.7|-0.6|0.076
73884787|NCT00834977|147303372|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.08||||||90.0|97.23|105.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.09|97.23|
73884788|NCT00834977|147303373|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.38||||||90.0|96.63|102.22|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.22|96.63|
73884789|NCT00834977|147303374|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.48||||||90.0|95.8|101.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.23|95.80|
73884790|NCT00834977|147303375|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.72||||||90.0|86.95|112.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.09|86.95|
73884791|NCT00834977|147303376|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.69||||||90.0|90.54|101.14|||||Metabolite presented for informational purposes only.|||101.14|90.54|
73884792|NCT00834977|147303377|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|99.43||||||90.0|96.48|102.46|||||Metabolite presented for informational purposes only.|||102.46|96.48|
74075007|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 70|5.1||||0.019|TWO_SIDED|95.0|0.7|9.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||9.4|0.7|0.019
73884793|NCT00834977|147303378|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|97.2||||||90.0|92.82|101.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.78|92.82|
73884794|NCT00834977|147303379|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|96.99||||||90.0|92.52|101.68|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.68|92.52|
73884795|NCT00834977|147303380|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.24||||||90.0|96.21|102.35|||||Metabolite presented for informational purposes only.|||102.35|96.21|
73884796|NCT01231984|147303392|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 8mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units.|Effect of 4mm versus 8mm PN on HbA1c|-0.076|||||TWO_SIDED|95.0|-0.209|0.058|||Two one-sided 95% confidence limits|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||0.058|-0.209|
73884797|NCT01231984|147303393|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4 mm PN and the longer PNs (pooled) was calculated. Equivalence limits for HbA1c were defined a-priori as +/- 0.4% units.|Effect of 4mm PN vs. longer PN on HbA1c|-0.09|||||TWO_SIDED|95.0|-0.23|0.051|||Two one-sided 95% confidence limits|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||0.051|-0.23|
73884798|NCT01231984|147303394|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.36|||<|0.05|ONE_SIDED|95.0|0.37|||p\< 0.05 was considered statistically significant in this study|t-test, 1 sided|||"Subjects rated the level of pain experienced when using the PN assigned for use during Study Period 2 compared to the PN assigned for use in Study Period 1. By placing a mark on a line, whose midpoint(anchor) was designated as 0, and represented equivalent pain with assigned PNs, ratings on the continuum represented the degree to which the PN used in the second Study Period was less than or greater than the PN used during the first Study Period."|||0.37|<0.05
73884799|NCT01231984|147303395|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.83|||<|0.05|ONE_SIDED|95.0|18.54|||p\< 0.05 was considered statistically significant in this study.|t-test, 1 sided||||||18.54|<0.05
73884800|NCT01231984|147303397|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 12.7mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units|Effect of 4 mm vs.12.7mm PN on HbA1c|-0.095|||||TWO_SIDED|95.0|-0.19|0.0|||Two one-sided 95% confidence limit|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||-0.000|-0.190|
73884801|NCT01968447|147303399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
73884802|NCT02923726|147303422|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.005|TWO_SIDED|95.9|0.57|0.92|||Log Rank||Shock only was the reference group. Confidence interval adjusted for interim analyses.|||0.92|0.57|0.005
73884803|NCT02923726|147303423|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.284|TWO_SIDED|95.0|0.78|1.07|||Log Rank||Shock Only was the reference group.|||1.07|0.78|0.284
73884804|NCT02923726|147303424|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.56|0.95|||Log Rank||Shock Only arm is reference group.|||0.95|0.56|0.020
73884805|NCT02923726|147303425|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.033|TWO_SIDED|95.0|0.44|0.97|||Log Rank||Shock Only is the reference group.|||0.97|0.44|0.033
73884806|NCT02923726|147303426|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.184|TWO_SIDED|95.0|0.94|1.41|||Log Rank||Shock Only is the reference group.|||1.41|0.94|0.184
73884807|NCT03324607|147303427|OTHER|||||||0.006|||||||Paired t-test|||||||0.006
73884808|NCT03402217|147303443|SUPERIORITY|||||||0.383|||||||Wilcoxon (Mann-Whitney)|||Pre and post-score paired comparison.||||.383
73884809|NCT03402217|147303444|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Information pre-post paired comparison||||.001
73884810|NCT03402217|147303444|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Motivation pre- and post-paired comparison.||||.07
73884811|NCT03402217|147303444|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Behavior pre and post paired comparison||||.230
73884812|NCT02992288|147303482|SUPERIORITY|||||||0.2297||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2297
73884813|NCT02992288|147303482|SUPERIORITY|||||||0.4409||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.4409
73884814|NCT02992288|147303482|SUPERIORITY|||||||0.2842||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2842
73884815|NCT02992288|147303482|SUPERIORITY|||||||0.2534||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2534
73884816|NCT02992288|147303482|SUPERIORITY|||||||0.3842||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.3842
73884817|NCT02992288|147303483|SUPERIORITY|||||||0.8966||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8966
73884818|NCT02992288|147303483|SUPERIORITY|||||||0.9233||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9233
73884819|NCT02992288|147303483|SUPERIORITY|||||||0.9296||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9296
73884820|NCT02992288|147303483|SUPERIORITY|||||||0.7357||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7357
73884821|NCT02992288|147303483|SUPERIORITY|||||||0.9083||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9083
73884822|NCT02992288|147303484|SUPERIORITY|||||||0.4596||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.4596
73884823|NCT02992288|147303484|SUPERIORITY|||||||0.7859||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7859
74075008|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 20|28.0|||<|0.001|TWO_SIDED|95.0|17.4|38.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||38.7|17.4|<0.001
74075009|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 50|12.0||||0.002|TWO_SIDED|95.0|4.1|19.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||19.8|4.1|0.002
74075010|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 70|5.1||||0.033|TWO_SIDED|95.0|0.4|9.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||9.8|0.4|0.033
74075011|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 20|25.9|||<|0.001|TWO_SIDED|95.0|15.1|36.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||36.8|15.1|<0.001
74075012|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 50|14.2|||<|0.001|TWO_SIDED|95.0|6.6|21.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||21.9|6.6|<0.001
74075013|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 70|7.8||||0.002|TWO_SIDED|95.0|2.6|13.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||13.0|2.6|0.002
74075014|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 20|35.5|||<|0.001|TWO_SIDED|95.0|24.6|46.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||46.5|24.6|<0.001
74075015|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 50|20.9|||<|0.001|TWO_SIDED|95.0|12.2|29.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||29.5|12.2|<0.001
74075016|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 70|10.2|||<|0.001|TWO_SIDED|95.0|4.4|16.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||16.0|4.4|<0.001
73884824|NCT02992288|147303484|SUPERIORITY|||||||0.5562||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5562
74075017|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 20|30.8|||<|0.001|TWO_SIDED|95.0|20.0|41.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||41.7|20.0|<0.001
74075018|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 50|16.6|||<|0.001|TWO_SIDED|95.0|8.6|24.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||24.5|8.6|<0.001
74075019|NCT00048581|147702901|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 70|8.7||||0.003|TWO_SIDED|95.0|2.7|14.6|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||14.6|2.7|0.003
74075020|NCT00048581|147702922|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 PCS|3.63|||<|0.001|TWO_SIDED|95.0|1.89|5.38|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.38|1.89|<0.001
74075021|NCT00048581|147702922|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 MCS|2.57||||0.017|TWO_SIDED|95.0|0.47|4.67|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.67|0.47|0.017
74075022|NCT00048581|147702922|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Physical Function|1.7||||0.052|TWO_SIDED|95.0|-0.01|3.41|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||3.41|-0.01|0.052
74075023|NCT00048581|147702922|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Role-Physical|3.01||||0.007|TWO_SIDED|95.0|0.83|5.19|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.19|0.83|0.007
74075024|NCT00048581|147702922|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Bodily Pain|5.62|||<|0.001|TWO_SIDED|95.0|3.77|7.47|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.47|3.77|<0.001
74075025|NCT00048581|147702922|SUPERIORITY_OR_OTHER||Adj Diff: General Health|2.51||||0.001|TWO_SIDED|95.0|0.99|4.02|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.02|0.99|0.001
74075026|NCT00048581|147702922|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Vitality|3.17||||0.001|TWO_SIDED|95.0|1.24|5.1|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.10|1.24|0.001
74075027|NCT00048581|147702922|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Social Functioning|4.69|||<|0.001|TWO_SIDED|95.0|2.59|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.79|2.59|<0.001
74075028|NCT00048581|147702922|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Role Emotional|0.97||||0.494|TWO_SIDED|95.0|-1.82|3.77|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||3.77|-1.82|0.494
74075029|NCT00048581|147702922|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Mental Health|2.59||||0.009|TWO_SIDED|95.0|0.65|4.54|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.54|0.65|0.009
74075030|NCT00048581|147702924|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 PCS|5.46|||<|0.001|TWO_SIDED|95.0|3.64|7.29|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.29|3.64|<0.001
74075031|NCT00048581|147702924|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 MCS|3.04||||0.005|TWO_SIDED|95.0|0.91|5.17|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.17|0.91|0.005
74075032|NCT00048581|147702924|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Physical Function|4.03|||<|0.001|TWO_SIDED|95.0|2.08|5.98|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.98|2.08|<0.001
74075033|NCT00048581|147702924|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Role-Physical|5.22|||<|0.001|TWO_SIDED|95.0|3.1|7.35|||ANCOVA|||||7.35|3.10|<0.001
74075034|NCT00048581|147702924|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Bodily Pain|6.24|||<|0.001|TWO_SIDED|95.0|4.37|8.11|||ANCOVA|||||8.11|4.37|<0.001
74075035|NCT00048581|147702924|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 General Health|3.27|||<|0.001|TWO_SIDED|95.0|1.64|4.9|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.90|1.64|<0.001
74075036|NCT00048581|147702924|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Vitality|4.78|||<|0.001|TWO_SIDED|95.0|2.76|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.79|2.76|<0.001
74075037|NCT00048581|147702924|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Social Functioning|4.92|||<|0.001|TWO_SIDED|95.0|2.71|7.12|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.12|2.71|<0.001
74075038|NCT00048581|147702924|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Role Emotional|3.54||||0.013|TWO_SIDED|95.0|0.74|6.33|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.33|0.74|0.013
74075039|NCT00048581|147702924|SUPERIORITY_OR_OTHER||Adj Diff: Mental Health|2.7||||0.006|TWO_SIDED|95.0|0.79|4.6|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.60|0.79|0.006
74075040|NCT00048581|147702926|SUPERIORITY_OR_OTHER||Adj M Chg from BL: HAQ-DI|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.23|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL||-0.23|-0.44|<0.001
74075041|NCT00048581|147702926|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Dressing and Grooming|-0.32|||<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL||-0.14|-0.49|<0.001
74075042|NCT00048581|147702926|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Arising|-0.32|||<|0.001|TWO_SIDED|95.0|-0.47|-0.16|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL||-0.16|-0.47|<0.001
74075043|NCT00048581|147702926|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Eating|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.3|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL||-0.30|-0.65|<0.001
74075044|NCT00048581|147702926|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Walking|-0.26||||0.003|TWO_SIDED|95.0|-0.44|-0.09|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.09|-0.44|0.003
74075045|NCT00048581|147702926|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Hygiene|-0.22||||0.01|TWO_SIDED|95.0|-0.39|-0.05|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.05|-0.39|0.010
73884825|NCT02992288|147303484|SUPERIORITY|||||||0.5338||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5338
73884826|NCT02992288|147303484|SUPERIORITY|||||||0.7303||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7303
73884827|NCT02992288|147303485|SUPERIORITY|||||||0.5703||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5703
73884828|NCT02992288|147303485|SUPERIORITY|||||||0.8253||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8253
73884829|NCT02992288|147303485|SUPERIORITY|||||||0.6506||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.6506
73884830|NCT02992288|147303485|SUPERIORITY|||||||0.6923||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.6923
73884831|NCT02992288|147303485|SUPERIORITY|||||||0.8036||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8036
73884832|NCT02992288|147303486|SUPERIORITY|||||||0.9955||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9955
73884833|NCT02992288|147303486|SUPERIORITY|||||||0.9946||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9946
73884834|NCT02992288|147303486|SUPERIORITY|||||||0.9913||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9913
73884835|NCT02992288|147303486|SUPERIORITY|||||||0.9982||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9982
73884836|NCT02992288|147303486|SUPERIORITY|||||||0.9959||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9959
73884837|NCT03416985|147303490|OTHER|||||||0.1561||||||p \< 0.05 considered significant|ANOVA|||Compare groups with respect to plaque level after 30 days||||0.1561
73884838|NCT03416985|147303491|OTHER|||||||0.2161||||||p \< 0.05 considered significant|ANOVA|||Compare groups with respect to Gingival scores at 30 days||||0.2161
73884839|NCT02006472|147303492|SUPERIORITY||LSM difference|1.42||||0.3202|TWO_SIDED|95.0|-1.39|4.23|||Mixed Models Analysis|||||4.23|-1.39|0.3202
73884840|NCT02006472|147303492|SUPERIORITY||LSM difference|1.7||||0.2266|TWO_SIDED|95.0|-1.06|4.46|||Mixed Models Analysis|||||4.46|-1.06|0.2266
73884841|NCT02006472|147303492|SUPERIORITY||LSM difference|0.66||||0.6348|TWO_SIDED|95.0|-2.07|3.39|||Mixed Models Analysis|||||3.39|-2.07|0.6348
73884842|NCT02006472|147303492|SUPERIORITY||LSM difference|2.04||||0.1447|TWO_SIDED|95.0|-0.71|4.8|||Mixed Models Analysis|||||4.8|-0.71|0.1447
73884843|NCT02006472|147303494|SUPERIORITY||LSM difference|0.87||||0.0032|TWO_SIDED|95.0|0.29|1.45|||Mixed Models Analysis|||||1.45|0.29|0.0032
73884844|NCT02006472|147303494|SUPERIORITY||LSM difference|0.11||||0.7042|TWO_SIDED|95.0|-0.46|0.68|||Mixed Models Analysis|||||0.68|-0.46|0.7042
73884845|NCT02006472|147303494|SUPERIORITY||LSM difference|0.19||||0.5099|TWO_SIDED|95.0|-0.37|0.75|||Mixed Models Analysis|||||0.75|-0.37|0.5099
73884846|NCT02006472|147303494|SUPERIORITY||LSM difference|0.24||||0.4061|TWO_SIDED|95.0|-0.33|0.82|||Mixed Models Analysis|||||0.82|-0.33|0.4061
73884847|NCT02006472|147303495|SUPERIORITY||LSM difference|1.16||||0.0003|TWO_SIDED|95.0|0.54|1.78|||Mixed Models Analysis|||||1.78|0.54|0.0003
73884848|NCT02006472|147303496|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
73884849|NCT02006472|147303497|SUPERIORITY||LSM difference|-0.0341||||0.0346|TWO_SIDED|95.0|-0.0658|-0.0026|||Mixed Models Analysis|||At Week 26||-0.0026|-0.0658|0.0346
74075046|NCT00048581|147702926|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Reaching|-0.43|||<|0.001|TWO_SIDED|95.0|-0.61|-0.25|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.25|-0.61|<0.001
74075047|NCT00048581|147702926|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Gripping|-0.32|||<|0.001|TWO_SIDED|95.0|-0.49|-0.15|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.15|-0.49|<0.001
74075048|NCT00048581|147702926|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Activities|-0.4|||<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.22|-0.58|<0.001
73884850|NCT02006472|147303497|SUPERIORITY||LSM difference|-0.0444||||0.0305|TWO_SIDED|95.0|-0.0847|-0.0042|||Mixed Models Analysis|||At Week 52||-0.0042|-0.0847|0.0305
73884851|NCT01436149|147303508|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.96||0.883|TWO_SIDED|95.0|-1.7|2.0|||Mixed- effects Model for Repeat Measures|||||2.0|-1.7|0.883
73884852|NCT01436149|147303509|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.69||0.576|TWO_SIDED|95.0|-1.8|1.0|||Mixed- effects Model for Repeat Measures|||||1.0|-1.8|0.576
73884853|NCT00573508|147303538|SUPERIORITY_OR_OTHER||Least Square Mean Difference|9.4|||<|0.0001||95.0|6.6|12.2|||ANCOVA|||Statistical Analysis applies to 'Change at End of Treatment'.||12.2|6.6|<0.0001
73884854|NCT00573508|147303539|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical Analysis applies to 'Change at Week 4', 'Change at Week 8' and 'Change at Week 12'.||||<.0001
73884855|NCT00573508|147303540|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-Value represents change from Baseline to Week 12.|ANCOVA|||Statistical Analysis applies to 'Change at Week 12'.||||<.0001
73884856|NCT00573508|147303541|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
73884857|NCT00573508|147303549|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-16.8|||<|0.0001||95.0|-22.1|-11.6|||ANCOVA|||Statistical Analysis applies to 'Change at EOT'.||-11.6|-22.1|<.0001
73884858|NCT02718898|147303552|SUPERIORITY||Odds Ratio (OR)|33.8|||<|0.001|TWO_SIDED|95.0|12.39|92.23|||Regression, Logistic|||||92.23|12.39|<0.001
73884859|NCT02718898|147303553|SUPERIORITY||Odds Ratio (OR)|102.55|||<|0.001|TWO_SIDED|95.0|22.79|461.43|||Regression, Logistic|||||461.43|22.79|<0.001
73884860|NCT02718898|147303554|SUPERIORITY||Odds Ratio (OR)|16.27|||<|0.001|TWO_SIDED|95.0|5.71|46.4|||Regression, Logistic|||||46.40|5.71|<0.001
73884861|NCT02718898|147303555|SUPERIORITY||Odds Ratio (OR)|13.57|||<|0.001|TWO_SIDED|95.0|4.57|40.29|||Regression, Logistic|||||40.29|4.57|<0.001
73884862|NCT02718898|147303556|SUPERIORITY||Odds Ratio (OR)|9.84|||<|0.001|TWO_SIDED|95.0|3.08|31.4|||Regression, Logistic|||||31.40|3.08|<0.001
73884863|NCT02718898|147303557|SUPERIORITY||Mean Difference (Final Values)|-8.4|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|-10.1|-6.7|||Mixed Models Analysis|||||-6.7|-10.1|<0.001
73884864|NCT02718898|147303558|SUPERIORITY||Mean Difference (Final Values)|-20.0|STANDARD_ERROR_OF_MEAN|2.15|<|0.001|TWO_SIDED|95.0|-24.3|-15.8|||Mixed Models Analysis|||||-15.8|-24.3|<0.001
73884865|NCT02718898|147303559|SUPERIORITY||Odds Ratio (OR)|13.95|||<|0.001|TWO_SIDED|95.0|6.12|31.8|||Regression, Logistic|||||31.80|6.12|<0.001
73884866|NCT02718898|147303560|SUPERIORITY||Mean Difference (Final Values)|4.506|STANDARD_ERROR_OF_MEAN|1.1339|<|0.001|TWO_SIDED|95.0|2.264|6.748|||ANCOVA|||||6.748|2.264|<0.001
73884867|NCT02718898|147303561|SUPERIORITY||Mean Difference (Final Values)|1.797|STANDARD_ERROR_OF_MEAN|1.0367||0.085|TWO_SIDED|95.0|-0.253|3.847|||ANCOVA|||||3.847|-0.253|0.085
73884868|NCT02718898|147303562|SUPERIORITY||Mean Difference (Final Values)|-28.75|STANDARD_ERROR_OF_MEAN|3.015|<|0.001|TWO_SIDED|95.0|-34.72|-22.78|||Mixed Models Analysis|||Total Score||-22.78|-34.72|<0.001
73884869|NCT02718898|147303562|SUPERIORITY||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|0.399|<|0.001|TWO_SIDED|95.0|-4.6|-3.02|||Mixed Models Analysis|||Itch||-3.02|-4.60|<0.001
74075049|NCT01059903|147702983|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9028|||||TWO_SIDED|90.0|0.8411|0.969|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||0.9690|0.8411|
74075050|NCT01059903|147702984|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9506|||||TWO_SIDED|90.0|0.8833|1.0231|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0231|0.8833|
74075051|NCT01059903|147702985|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9046|||||TWO_SIDED|90.0|0.8437|0.9699|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||0.9699|0.8437|
74075052|NCT02100228|147703006|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.0||||0.0151|TWO_SIDED|95.0|0.0|0.6425||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||0.6425|0.0000|0.0151
73884870|NCT02718898|147303562|SUPERIORITY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|0.405|<|0.001|TWO_SIDED|95.0|-4.3|-2.7|||Mixed Models Analysis|||Pain||-2.70|-4.30|<0.001
73884871|NCT02718898|147303562|SUPERIORITY||Mean Difference (Final Values)|-3.85|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-4.66|-3.04|||Mixed Models Analysis|||Discomfort||-3.04|-4.66|<0.001
73884872|NCT02718898|147303562|SUPERIORITY||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-4.04|-2.42|||Mixed Models Analysis|||Stinging||-2.42|-4.04|<0.001
73884873|NCT02718898|147303562|SUPERIORITY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-3.99|-2.41|||Mixed Models Analysis|||Burning||-2.41|-3.99|<0.001
74075053|NCT02100228|147703008|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.4905||||0.3378|TWO_SIDED|95.0|0.1046|2.0678||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||2.0678|0.1046|0.3378
74075054|NCT02100228|147703009|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.83||||0.6851|TWO_SIDED|95.0|0.3433|1.8916||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||1.8916|0.3433|0.6851
73884874|NCT02718898|147303562|SUPERIORITY||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|0.395|<|0.001|TWO_SIDED|95.0|-4.59|-3.03|||Mixed Models Analysis|||Redness||-3.03|-4.59|<0.001
73884875|NCT02718898|147303562|SUPERIORITY||Mean Difference (Final Values)|-3.78|STANDARD_ERROR_OF_MEAN|0.377|<|0.001|TWO_SIDED|95.0|-4.53|-3.03|||Mixed Models Analysis|||Scaling||-3.03|-4.53|<0.001
74075055|NCT02100228|147703010|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|1.9841|||>|0.9999|TWO_SIDED|95.0|0.1866|53.9968||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||53.9968|0.1866|>0.9999
73884876|NCT02718898|147303562|SUPERIORITY||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|0.385|<|0.001|TWO_SIDED|95.0|-4.31|-2.79|||Mixed Models Analysis|||Cracking||-2.79|-4.31|<0.001
73884877|NCT00627393|147303584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.73|TWO_SIDED|95.0|0.44|3.2|||Regression, Logistic|Ordinary multiple logistic regression including treatment arm, infection strata, underlying disease, zubrod score, respiratory symptoms, and age.|Control group is the reference group. Model adjusted for infection strata, underlying disease, zubrod score, respiratory symptoms, and age.|||3.20|0.44|0.73
73884878|NCT00627393|147303587|SUPERIORITY_OR_OTHER||Log Rank P-Value|0.43||||0.43|TWO_SIDED|||||Competing risks analysis for time to GVHD for subjects with allogeneic HST. The sample size was very small (n=7 in the granulocyte group, and n=8 in the control group).|Competing Risks|||||||0.43
73884879|NCT00627393|147303592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.293|STANDARD_ERROR_OF_MEAN|0.25885||0.35|TWO_SIDED|95.0|0.778|2.147|||Log Rank|Log-rank test to compare survival distributions between the control group and treatment group.|The control group is considered the reference group.|||2.147|0.778|0.35
74075056|NCT03567174|147703035|SUPERIORITY||Mean Difference (Net)|-0.306||||0.125|TWO_SIDED|95.0|-0.697|0.085|||Mixed Models Analysis|||||0.085|-0.697|0.125
74075057|NCT01375660|147703145|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||ANOVA|||||||0.026
74075058|NCT01375660|147703146|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||||||0.6
74075059|NCT01375660|147703147|SUPERIORITY_OR_OTHER|||||||0.389|TWO_SIDED||||||ANOVA|||||||0.389
74075060|NCT01375660|147703148|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||P Value for Insulinogenic Index-30 = 0.34|ANOVA|||||||0.34
74075061|NCT01375660|147703149|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
74075062|NCT01375660|147703150|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||0.13
74075063|NCT01375660|147703151|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED||||||Chi-squared|||||||0.869
74075064|NCT02058498|147703160|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
74075065|NCT05327491|147703162|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.962|||||TWO_SIDED|90.0|0.88|1.053||||||||1.053|0.880|
74075066|NCT05327491|147703163|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.968|||||TWO_SIDED|90.0|0.907|1.033||||||||1.033|0.907|
74075067|NCT05327491|147703164|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.967|||||TWO_SIDED|90.0|0.908|1.029||||||||1.029|0.908|
74075068|NCT01171989|147703171|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.27|2.84||||||Difference in percentage anti-PRP ≥ 0.15 μg/mL||2.84|-3.27|
74075069|NCT01171989|147703172|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.27|2.86||||||Difference between groups for rSBA-MenC ≥1:8||2.86|-3.27|
74075070|NCT01171989|147703172|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.02|2.86||||||Difference between groups for rSBA-MenC ≥1:8||2.86|-3.02|
74075071|NCT01391793|147703234|SUPERIORITY|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\<24 months, \>=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with renal scarring at the outcome DMSA renal scan.||||0.16
74075072|NCT01391793|147703235|SUPERIORITY|||||||0.25|||||||Test of equality - 2 Poisson parameters|The method used is a conditional test.||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with severe renal scarring at the outcome DMSA renal scan.||||0.25
74075073|NCT01391793|147703236|SUPERIORITY|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\<24 months, \>=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the mean proportion of children with renal scarring at the outcome DMSA scan taken across the 3 radiologists.||||0.07
74075074|NCT00105196|147703237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.73|||<|0.001||95.0|-5.44|-2.02|||t-test, 2 sided|||The sample size for the study was based on the primary outcome measure. The study was powered at 90% to detect a treatment difference between adjunctive aripiprazole and adjunctive placebo of 3.75, assuming a standard deviation of 10.5 and a two-sided alpha level of 0.05. The null-hypothesis was the lack of a treatment difference.||-2.02|-5.44|<0.001
74075075|NCT00105196|147703238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.075||95.0|-0.88|0.04|||t-test, 2 sided|||To protect the overall (primary and key secondary efficacy analysis) alpha level of 0.05, for this key secondary endpoint a hierarchical testing procedure was followed such that formal testing would take place conditional on the primary efficacy analysis showing a statistically significant difference.||0.04|-0.88|0.075
74075076|NCT00105196|147703239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.052||95.0|-1.06|0.0||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||0.00|-1.06|0.052
74075077|NCT00105196|147703240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.037||95.0|-1.1|-0.03||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||-0.03|-1.10|0.037
74075078|NCT00105196|147703241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.792||95.0|-0.67|0.51||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||0.51|-0.67|0.792
73884880|NCT03337308|147303600|SUPERIORITY||Difference of Least Squares (LS) means|-38.0|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-46.5|-29.6|||ANCOVA||Standard Error of the Difference of Least Squares (LS) Means|||-29.6|-46.5|<0.001
73884881|NCT03337308|147303600|SUPERIORITY||Difference of LS means|-19.0|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-26.1|-11.9|||ANCOVA||Standard Error of the Difference of LS Means|||-11.9|-26.1|<0.001
74075079|NCT00105196|147703242|SUPERIORITY_OR_OTHER||Ratio of response|1.74|||<|0.001||95.0|1.31|2.32||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo|||2.32|1.31|<0.001
73884882|NCT03337308|147303600|SUPERIORITY||Difference of LS means|-13.1|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-19.7|-6.5|||ANCOVA||Standard Error of the Difference of LS Means|||-6.5|-19.7|<0.001
74075080|NCT00105196|147703243|SUPERIORITY_OR_OTHER||Ratio of response|1.43|||<|0.001||95.0|1.17|1.74||No adjustment for multiple comparisons was implemented for this secondary endpoint.|ANCOVA||aripiprazole/placebo|||1.74|1.17|<0.001
73884883|NCT03337308|147303601|SUPERIORITY||Location shift|-46.1|STANDARD_ERROR_OF_MEAN|12.22|<|0.001|TWO_SIDED|99.0|-78.75|-15.78||using alpha = 0.01|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||-15.78|-78.75|<0.001
74075081|NCT00105196|147703244|SUPERIORITY_OR_OTHER||Ratio of remission|1.95|||<|0.001||95.0|1.36|2.8||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo|||2.80|1.36|<0.001
74075082|NCT00286754|147703274|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of SMI vs. UC|Wilcoxon (Mann-Whitney)|||The study was an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. We expected that 54% of patients on BP-lowering therapy would be properly controlled with HEI and 43% with UC, whereas we expected SMI to increase this to 69% control in 6 months. BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), ie, 1.25% for each of the 4 comparisons.||||0.001
73884884|NCT03337308|147303601|SUPERIORITY||Median Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|8.14||0.002|TWO_SIDED|98.0|-45.0|-7.15||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||-7.15|-45.00|0.002
73884885|NCT03337308|147303601|SUPERIORITY||Median Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|8.08||0.734|TWO_SIDED|98.0|-21.35|16.25||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||16.25|-21.35|0.734
74075083|NCT00286754|147703274|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)|||||||0.108
73884886|NCT03337308|147303602|SUPERIORITY|using alpha = 0.01|Difference in LS mean|-33.7|STANDARD_ERROR_OF_MEAN|3.97|<|0.001|TWO_SIDED|99.0|-43.9|-23.4|||ANCOVA||Standard Error of the Difference of LS Means|||-23.4|-43.9|<0.001
74075084|NCT00286754|147703275|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for SMI vs UC|Wilcoxon (Mann-Whitney)|||The study was designed as an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. The study was not powered to test comparisons between the 2 active intervention arms.||||0.009
74075085|NCT00286754|147703275|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)|||||||0.047
74075086|NCT00286754|147703276|SUPERIORITY_OR_OTHER||||||<|3e-06|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||<0.000003
74075087|NCT00286754|147703276|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||0.012
74075088|NCT00286754|147703276|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||0.89
74075089|NCT00286754|147703277|SUPERIORITY_OR_OTHER||||||<|0.009|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||<0.009
74075090|NCT00286754|147703277|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.008
74075091|NCT00286754|147703277|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.9
74075092|NCT00286754|147703278|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)|||||||0.880
74075093|NCT00286754|147703278|SUPERIORITY_OR_OTHER|||||||0.318|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.318
74075094|NCT00286754|147703279|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)|||||||0.306
74075095|NCT00286754|147703279|SUPERIORITY_OR_OTHER|||||||0.205|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.205
74075096|NCT00286754|147703280|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.011
74075097|NCT00286754|147703280|SUPERIORITY_OR_OTHER|||||||0.638|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.638
74075098|NCT00286754|147703281|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.012
73884887|NCT03337308|147303602|SUPERIORITY||Difference in LS means|-17.8|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|98.0|-25.1|-10.5||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-10.5|-25.1|<0.001
73884888|NCT03337308|147303602|SUPERIORITY||Difference in LS means|-12.1|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|98.0|-19.1|-5.0||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-5.0|-19.1|<0.001
73884889|NCT03337308|147303603|SUPERIORITY||Difference of LS means|-27.1|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|99.0|-35.1|-19.1||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means|||-19.1|-35.1|<0.001
73884890|NCT03337308|147303603|SUPERIORITY||Difference of LS means|-14.2|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|98.0|-20.4|-8.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-8.1|-20.4|<0.001
74075099|NCT00286754|147703281|SUPERIORITY_OR_OTHER|||||||0.333|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.333
74075100|NCT00286754|147703282|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.581
74075101|NCT00286754|147703282|SUPERIORITY_OR_OTHER|||||||0.502|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.502
74075102|NCT02726581|147703294|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.62|1.3||||||||1.30|0.62|
74075103|NCT02726581|147703295|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.53|1.19||||||||1.19|0.53|
74075104|NCT02726581|147703296|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.39|1.46||||||||1.46|0.39|
74075105|NCT00552669|147703300|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||We used One way annalysis of a variance for means and standard deviation.||||<0.05
73884891|NCT03337308|147303603|SUPERIORITY||Difference of LS means|-10.4|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|98.0|-16.1|-4.6||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-4.6|-16.1|<0.001
73884892|NCT03337308|147303604|SUPERIORITY||Difference of LS means|-30.1|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|99.0|-39.9|-20.3||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means|||-20.3|-39.9|<0.001
73884893|NCT03337308|147303604|SUPERIORITY||Difference of LS means|-12.8|STANDARD_ERROR_OF_MEAN|3.23|<|0.001|TWO_SIDED|98.0|-20.3|-5.3||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-5.3|-20.3|<0.001
73884894|NCT03337308|147303604|SUPERIORITY||Difference of LS means|-9.3|STANDARD_ERROR_OF_MEAN|3.09||0.003|TWO_SIDED|98.0|-16.5|-2.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-2.1|-16.5|0.003
73884895|NCT03474588|147303735|SUPERIORITY|||||||0.3||||||Presented is the p value for the interaction between time and treatment.|Regression, Linear|Random Effects Regression Models (RERM), time was log transformed to account for expectation of greater change closer to baseline||||||0.30
73884896|NCT03474588|147303736|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|0.94||0.14|TWO_SIDED|95.0|-0.46|3.24||presented is the p value for the interaction of treatment and time in the model.|Regression, Linear|||Random Effects Regression Model (RERM), included in the model were treatment, time and the interaction of time and treatment.||3.24|-0.46|0.14
73884897|NCT03474588|147303737|SUPERIORITY|||||||0.097|||||||ANOVA|||||||0.097
73884898|NCT03474588|147303738|SUPERIORITY|||||||0.802|||||||Chi-squared|||||||0.802
73884899|NCT00498940|147303747|SUPERIORITY_OR_OTHER|||||||0.14||||||Differences in cardiac index between groups were assessed by an independent 2-sample t test.|t-test, 2 sided|||||||.14
73884900|NCT00626106|147303755|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.542|TWO_SIDED|95.0|-0.11|0.07|||ANCOVA|||||0.07|-0.11|0.542
73884901|NCT00781768|147303774|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED||||||Chi-squared|||The null hypothesis is that there will be a higher proportion of complete responders among those subjects receiving the combination therapy.||||<.001
73884902|NCT04567628|147303777|OTHER||||||=|0.003|||||||Spearman's Rank Correlation|||||||=0.003
73884903|NCT04567628|147303778|OTHER||||||=|0.25||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||=0.25
73884904|NCT04567628|147303781|OTHER||||||<|0.001||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||<0.001
73884905|NCT04567628|147303783|OTHER||||||<|0.0001||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||<0.0001
73884906|NCT02458313|147303789|SUPERIORITY|DMXB-A vs. Placebo groups compared at baseline||||||0.647|||||||t-test, 2 sided|||||||0.647
73884907|NCT02458313|147303789|SUPERIORITY|||||||0.679|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared post-intervention||||0.679
73884908|NCT02458313|147303790|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared at baseline||||0.951
73884909|NCT02458313|147303790|SUPERIORITY|||||||0.884|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared post-intervention||||0.884
73884910|NCT00385671|147303848|NON_INFERIORITY_OR_EQUIVALENCE|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.49||||0.076|TWO_SIDED|95.0|-0.05|1.04||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between pregabalin \& duloxetine treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.||1.04|-0.05|0.076
73884911|NCT00385671|147303849|NON_INFERIORITY_OR_EQUIVALENCE|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.23||||0.417|TWO_SIDED|95.0|-0.32|0.78||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between duloxetine \& duloxetine+gabapentin treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.||0.78|-0.32|0.417
73884912|NCT00385671|147303850|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.463
73884913|NCT00385671|147303850|SUPERIORITY_OR_OTHER|||||||0.52||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.520
73884914|NCT00385671|147303850|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.463
73884915|NCT00385671|147303851|SUPERIORITY_OR_OTHER|||||||0.389||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.389
73884916|NCT00385671|147303851|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.126
73884917|NCT00385671|147303851|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.489
73884918|NCT00385671|147303852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.602|TWO_SIDED|95.0|-0.2|0.35||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Covariance model and t-tests: Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.35|-0.20|0.602
73884919|NCT00385671|147303852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.469|TWO_SIDED|95.0|-0.17|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.37|-0.17|0.469
73884920|NCT00385671|147303852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.841|TWO_SIDED|95.0|-0.24|0.3||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.30|-0.24|0.841
73884921|NCT00385671|147303853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.276|TWO_SIDED|95.0|-0.16|0.55||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in PGI-Improvement at 12 weeks.||0.55|-0.16|0.276
73884922|NCT00385671|147303853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.929|TWO_SIDED|95.0|-0.33|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in PGI-Improvement at 12 weeks.||0.37|-0.33|0.929
73884923|NCT00385671|147303853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.313|TWO_SIDED|95.0|-0.53|0.17||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in PGI-Improvement at 12 weeks.||0.17|-0.53|0.313
73884924|NCT00385671|147303854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.078|TWO_SIDED|95.0|-0.06|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||1.04|-0.06|0.078
74075106|NCT00552669|147703301|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||Based on our previous data the incidence of relevant clinical events was similar in both groups (ERACI III and ORAR II)||||0.05
74075107|NCT00552669|147703302|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||"power calculation 80% Hypothesis: No significant diferences between Target Vessel Revascularization (TVR) between both groups.~All events will be recorded and an independent blind for groups clinical events committee will adjudicate each one."||||<0.05
74075108|NCT01844375|147703303|EQUIVALENCE|equivalence analysis||||||0.75|||||||Kruskal-Wallis|||||||0.75
74075109|NCT03020615|147703313|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||||||0.033
74075110|NCT03020615|147703316|SUPERIORITY|||||||0.0005|||||||Exact Wilcoxon (Mann-Whitley), two-sided|||||||0.0005
74075111|NCT03020615|147703318|SUPERIORITY|||||||0.011|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.011
74075112|NCT03020615|147703319|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.030
74075113|NCT03020615|147703322|SUPERIORITY|||||||0.0009|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0009
74075114|NCT03020615|147703324|SUPERIORITY|||||||0.0004|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0004
74075115|NCT03020615|147703326|SUPERIORITY|||||||0.75|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.75
74075116|NCT03020615|147703328|SUPERIORITY|||||||0.0013|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0013
74075117|NCT03020615|147703329|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
74075118|NCT00904345|147703347|OTHER||||||||||||||||||Estimates of proportion event-free at 1 and 2 years calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals were calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
74075119|NCT00904345|147703348|OTHER||||||||||||||||||Survival proportion estimates at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
74075120|NCT00904345|147703352|OTHER||||||||||||||||||Estimates of proportion LRP event-free at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
74075121|NCT04239872|147703353|SUPERIORITY||Mean Difference (Net)|-0.00778||||0.8412|TWO_SIDED|95.0|-0.09209|0.07653||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 11 pairs of data, DF=10|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.07653|-0.09209|0.8412
74075122|NCT04239872|147703354|SUPERIORITY||Mean Difference (Net)|-0.06907||||0.6504|TWO_SIDED|95.0|-0.3955|0.2573||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 12 pairs of data, DF=11|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.2573|-0.3955|0.6504
74075123|NCT04239872|147703355|SUPERIORITY||Mean Difference (Net)|0.5307||||0.0024|TWO_SIDED|95.0|0.2372|0.8243||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 11 pairs of data, DF=10|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.8243|0.2372|0.0024
74075124|NCT04239872|147703356|SUPERIORITY||Mean Difference (Net)|0.5643||||0.0013|TWO_SIDED|95.0|0.2938|0.8348||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 9 pairs of data, DF=8|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.8348|0.2938|0.0013
74075125|NCT04239872|147703357|SUPERIORITY||Mean Difference (Net)|-0.1135||||0.2041|TWO_SIDED|95.0|-0.2964|0.06929||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 15 pairs of data, DF=14|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.06929|-0.2964|0.2041
74075126|NCT04239872|147703358|SUPERIORITY||Mean Difference (Net)|1.095|||<|0.0001|TWO_SIDED|95.0|0.7736|1.416||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.416|0.7736|<0.0001
74075127|NCT04239872|147703359|SUPERIORITY||Mean Difference (Net)|1.469|||<|0.0001|TWO_SIDED|95.0|1.112|1.825||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.825|1.112|<0.0001
74075128|NCT04239872|147703360|SUPERIORITY||Mean Difference (Net)|1.549|||<|0.0001|TWO_SIDED|95.0|1.081|2.017||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||2.017|1.081|<0.0001
74075129|NCT04239872|147703361|SUPERIORITY||Mean Difference (Net)|-115.6||||0.5543|TWO_SIDED|95.0|-584.8|353.6||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 6 pairs of data, DF=5|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||353.6|-584.8|0.5543
74075130|NCT04239872|147703362|SUPERIORITY||Mean Difference (Net)|1.328||||0.0003|TWO_SIDED|95.0|0.842|1.814||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 8 pairs of data, DF=7|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.814|0.8420|0.0003
74075131|NCT04239872|147703363|SUPERIORITY||Mean Difference (Net)|-0.09023||||0.2824|TWO_SIDED|95.0|-0.2613|0.08082||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 19 pairs of data, DF=18|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.08082|-0.2613|0.2824
74075132|NCT04239872|147703364|SUPERIORITY||Mean Difference (Net)|0.6269||||0.0002|TWO_SIDED|95.0|0.3488|0.905||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.9050|0.3488|0.0002
74075133|NCT04239872|147703365|SUPERIORITY||Mean Difference (Net)|0.8946|||<|0.0001|TWO_SIDED|95.0|0.6671|1.122||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.122|0.6671|<0.0001
74075134|NCT04239872|147703366|SUPERIORITY||Mean Difference (Net)|0.973|||<|0.0001|TWO_SIDED|95.0|0.7597|1.186||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.186|0.7597|<0.0001
74075135|NCT04239872|147703367|SUPERIORITY||Mean Difference (Net)|0.9827|||<|0.0001|TWO_SIDED|95.0|0.7758|1.19||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.19|0.7758|<0.0001
74075136|NCT04239872|147703368|SUPERIORITY||Mean Difference (Net)|0.9181|||<|0.0001|TWO_SIDED|95.0|0.6573|1.179||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 19 pairs of data, DF=18|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.179|0.6573|<0.0001
74075137|NCT04239872|147703373|SUPERIORITY||Mean Difference (Net)|-0.05652||||0.3283|TWO_SIDED|95.0|-0.1762|0.06829||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 15 pairs of data, DF=14|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.06829|-0.1762|0.3283
74075138|NCT04239872|147703374|SUPERIORITY||Mean Difference (Net)|0.3411||||0.0058|TWO_SIDED|95.0|0.1189|0.5633||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5633|0.1189|0.0058
73884925|NCT00385671|147303854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.025|TWO_SIDED|95.0|0.08|1.2||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||1.20|0.08|0.025
73884926|NCT00385671|147303854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.602|TWO_SIDED|95.0|-0.41|0.7||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||0.70|-0.41|0.602
73884927|NCT00385671|147303855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.353|TWO_SIDED|95.0|-0.34|0.94||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.||0.94|-0.34|0.353
73884928|NCT00385671|147303855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.039|TWO_SIDED|95.0|0.03|1.34||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.||1.34|0.03|0.039
74075139|NCT04239872|147703375|SUPERIORITY||Mean Difference (Net)|0.2976||||0.0213|TWO_SIDED|95.0|0.05266|0.5426||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5426|0.05266|0.0213
74075140|NCT04239872|147703376|SUPERIORITY||Mean Difference (Net)|0.312||||0.014|TWO_SIDED|95.0|0.07454|0.5495||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5495|0.07454|0.014
74075141|NCT04239872|147703377|SUPERIORITY||Mean Difference (Net)|0.2524||||0.1393|TWO_SIDED|95.0|-0.09153|0.5962||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.5962|-0.09153|0.1393
74075142|NCT04239872|147703378|SUPERIORITY||Mean Difference (Net)|0.2921||||0.0009|TWO_SIDED|95.0|0.1414|0.4427||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.4427|0.1414|0.0009
74075143|NCT04239872|147703379|SUPERIORITY||Mean Difference (Net)|0.2433||||0.0008|TWO_SIDED|95.0|0.1195|0.3671||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.3671|0.1195|0.0008
74075144|NCT04239872|147703380|SUPERIORITY||Mean Difference (Net)|0.3306||||0.1515|TWO_SIDED|95.0|-0.1356|0.7969||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.7969|-0.1356|0.1515
74075145|NCT04239872|147703381|SUPERIORITY||Mean Difference (Net)|0.04851||||0.1712|TWO_SIDED|95.0|-0.02327|0.1203||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.1203|-0.02327|0.1712
74075146|NCT04239872|147703382|SUPERIORITY||Mean Difference (Net)|0.2789||||0.1188|TWO_SIDED|95.0|-0.07934|0.6371||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.6371|-0.07934|0.1188
74075147|NCT04239872|147703383|SUPERIORITY||Mean Difference (Net)|0.8956|||<|0.0001|TWO_SIDED|95.0|0.7205|1.071||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.071|0.7205|<0.0001
74075148|NCT04239872|147703385|SUPERIORITY||Mean Difference (Net)|0.3199||||0.0475|TWO_SIDED|95.0|0.004686|0.6351||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 8 pairs of data, DF=7|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.6351|0.004686|0.0475
74075149|NCT04239872|147703386|SUPERIORITY||Mean Difference (Net)|50.38||||0.0004|TWO_SIDED|95.0|27.46|73.3||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||73.30|27.46|0.0004
74075150|NCT00578552|147703390|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.77
74075151|NCT00578552|147703390|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||1.00
74075152|NCT03693430|147703401|SUPERIORITY|Week 104 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline body weight as covariate. Missing observations were multiple (x1000) imputed from retrieved subjects of the same randomised treatment arm.|Treatment difference|-12.55|||<|0.0001|TWO_SIDED|95.0|-15.33|-9.77|||ANCOVA|||Treatment policy estimand||-9.77|-15.33|<.0001
74075153|NCT03693430|147703401|SUPERIORITY|All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements with randomised treatment as factor and baseline body weight as covariate, all nested within visit.|Treatment difference|-16.05|||<|0.0001|TWO_SIDED|95.0|-18.64|-13.45|||MMRM (Mixed model repeated measurement)|||Hypothetical estimand||-13.45|-18.64|<0.0001
74075154|NCT03693430|147703402|SUPERIORITY||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.95|8.42|||Regression, Logistic|||Treatment policy estimand||8.42|2.95|<0.0001
74075155|NCT03693430|147703402|SUPERIORITY||Odds Ratio (OR)|18.06|||<|0.0001|TWO_SIDED|95.0|10.04|32.49|||MMRM|||Hypothetical estimand||32.49|10.04|<0.0001
74075156|NCT00854100|147703506|SUPERIORITY||Least Squares Mean Difference|0.5||||0.746|TWO_SIDED|95.0|-2.4|3.4|||ANCOVA|||||3.4|-2.4|0.746
74075157|NCT00854100|147703506|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.227|TWO_SIDED|95.0|-4.8|1.1|||ANCOVA|||||1.1|-4.8|0.227
74075158|NCT00854100|147703507|SUPERIORITY||Least Squares Mean Difference|0.0||||0.918|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.918
74075159|NCT00854100|147703507|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.167|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.167
74075160|NCT04753437|147703548|EQUIVALENCE|Results were based on analysis of variance model with treatment as a fixed effect.|Geometric Least Squares (LS) Mean Ratio|1.3|||||TWO_SIDED|90.0|0.94|1.81||||||||1.81|0.94|
74075161|NCT04753437|147703549|EQUIVALENCE|Results were based on analysis of variance model with treatment as a fixed effect.|Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.82|1.4||||||||1.40|0.82|
74075162|NCT00840632|147703601|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|93.26||||||90.0|83.39|104.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.31|83.39|
74075163|NCT00840632|147703602|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.35||||||90.0|92.08|109.36|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.36|92.08|
74075164|NCT00840632|147703603|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.17||||||90.0|92.71|106.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.08|92.71|
74075165|NCT00840632|147703604|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|102.93||||||90.0|99.8|106.15|||||Informational Purposes Only|||106.15|99.80|
74075166|NCT00840632|147703605|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.24||||||90.0|98.11|102.43|||||Informational Purposes Only|||102.43|98.11|
74075167|NCT00840632|147703606|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.1||||||90.0|98.12|102.12|||||Informational Purposes Only|||102.12|98.12|
74075168|NCT03785548|147703653|OTHER||Mean Difference (Final Values)|2.851|STANDARD_ERROR_OF_MEAN|2.576||0.27|TWO_SIDED|95.0|-2.241|7.944|||ANCOVA|F(1, 140)=1.225||||7.944|-2.241|0.270
74075169|NCT03785548|147703654|OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|3.098||0.964|TWO_SIDED|95.0|-5.983|6.266|||ANCOVA|F(1, 140)=0.002||||6.266|-5.983|0.964
74075170|NCT01049334|147703657|SUPERIORITY_OR_OTHER||least-square means difference|-151.5||||0.0201|TWO_SIDED|95.0|-278.9|-24.0||The a priori threshold for statistical significance is 0.05. No adjustments for statistical multiplicity were required.|ANOVA|Treatment as a fixed effect and baseline STPIS as a covariate.||||-24.0|-278.9|0.0201
74075171|NCT01049334|147703658|SUPERIORITY_OR_OTHER||least-square means difference|-19.6|||<|0.0001|TWO_SIDED|95.0|-29.2|-9.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-9.9|-29.2|<.0001
74075172|NCT01049334|147703659|SUPERIORITY_OR_OTHER||least-square means difference|-22.3|||<|0.0001|TWO_SIDED|95.0|-31.7|-12.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-12.9|-31.7|<0.0001
74075173|NCT01049334|147703660|SUPERIORITY_OR_OTHER||least-square means difference|-181.7||||0.0071|TWO_SIDED|95.0|-313.7|-50.0||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-50.0|-313.7|0.0071
74075174|NCT01049334|147703661|SUPERIORITY_OR_OTHER||least-square means difference|-20.8|||<|0.0001|TWO_SIDED|95.0|-30.2|-11.2||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-11.2|-30.2|<0.0001
73884929|NCT00385671|147303855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.244|TWO_SIDED|95.0|-0.27|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Worst Pain.||1.04|-0.27|0.244
74075175|NCT01049334|147703662|SUPERIORITY_OR_OTHER||least-square means difference|-137.6||||0.0393|TWO_SIDED|95.0|-268.5|-6.8||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-6.8|-268.5|0.0393
74075176|NCT01049334|147703663|SUPERIORITY_OR_OTHER|||||||0.0459||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0459
74075177|NCT01049334|147703664|SUPERIORITY_OR_OTHER|||||||0.8383||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.8383
74075178|NCT01049334|147703665|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|95.0||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0005
74075179|NCT01049334|147703666|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0005
74075180|NCT01049334|147703667|SUPERIORITY_OR_OTHER|||||||0.0002||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0002
74075181|NCT01049334|147703668|SUPERIORITY_OR_OTHER||least-square means difference|-156.3||||0.0435|TWO_SIDED|95.0|-307.9|-4.6||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|||||-4.6|-307.9|0.0435
74075182|NCT01049334|147703669|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||<.0001
74075183|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.1448|TWO_SIDED|95.0|0.0|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 2||0.1|-0.0|0.1448
74075184|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.1538|TWO_SIDED|95.0|0.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 4||0.3|-0.0|0.1538
74075185|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.1407|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 6||0.5|-0.1|0.1407
74075186|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.2906|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 8||0.7|-0.2|0.2906
74075187|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.4758|TWO_SIDED|95.0|-0.4|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 10||0.8|-0.4|0.4758
74075188|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.6975|TWO_SIDED|95.0|-0.6|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 12||0.9|-0.6|0.6975
74075189|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|0.0||||0.937|TWO_SIDED|95.0|-0.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 14||0.9|-0.8|0.9370
74075190|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-0.1||||0.8493|TWO_SIDED|95.0|-1.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 16||0.9|-1.1|0.8493
74075191|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-0.3||||0.6732|TWO_SIDED|95.0|-1.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 18||0.9|-1.4|0.6732
74075192|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-0.4||||0.5414|TWO_SIDED|95.0|-1.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 20||0.9|-1.8|0.5414
74075193|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-0.6||||0.4313|TWO_SIDED|95.0|-2.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 22||0.9|-2.1|0.4313
74075194|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-0.8||||0.3501|TWO_SIDED|95.0|-2.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 24||0.9|-2.4|0.3501
73884930|NCT00385671|147303856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.298|TWO_SIDED|95.0|-0.25|0.8||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.||0.80|-0.25|0.298
74075195|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-1.0||||0.2679|TWO_SIDED|95.0|-2.8|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 26||0.8|-2.8|0.2679
74075196|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-1.2||||0.2137|TWO_SIDED|95.0|-3.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 28||0.7|-3.2|0.2137
74075197|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-1.5||||0.1715|TWO_SIDED|95.0|-3.6|0.6|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 30||0.6|-3.6|0.1715
74075198|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-1.8||||0.134|TWO_SIDED|95.0|-4.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 32||0.5|-4.1|0.1340
74075199|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-2.0||||0.103|TWO_SIDED|95.0|-4.5|0.4|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 34||0.4|-4.5|0.1030
74075200|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-2.4||||0.0788|TWO_SIDED|95.0|-5.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 36||0.3|-5.0|0.0788
74075201|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-2.7||||0.062|TWO_SIDED|95.0|-5.5|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 38||0.1|-5.5|0.0620
74075202|NCT01049334|147703670|SUPERIORITY_OR_OTHER||least-square means difference|-3.0||||0.0476|TWO_SIDED|95.0|-6.0|0.0|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 40||-0.0|-6.0|0.0476
74075203|NCT01049334|147703671|SUPERIORITY_OR_OTHER|||||||0.0273||95.0|||||Log Rank|||||||0.0273
74075204|NCT01049334|147703672|SUPERIORITY_OR_OTHER|||||||0.0098||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0098
74075205|NCT03979079|147703675|OTHER||Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.14|0.3||Estimation was performed using a Bayesian approach. As such, p-values are not estimated.|Two-stage model.||||Two-stage model within a Bayesian framework to assess the role of the prostate-specific antigens profile on clinical failure while accounting for a secondary treatment prescribed by indication. Prostatespecific antigens modeled using a hierarchical piecewise linear trajectory with a random changepoint. Residual prostate-specific antigens variability was expressed as a function of prostate-specific antigens concentration. Covariates in the survival model included hormone therapy, baseline characteristics, and individual predictions of the prostate-specific antigens nadir and timing and prostate-specific antigens slopes before and after the nadir as provided by the longitudinal process.|0.30|0.14|
74075206|NCT00667095|147703699|SUPERIORITY_OR_OTHER|||||||0.024|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.024
74075207|NCT00667095|147703699|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.036
74075208|NCT00667095|147703700|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.051
74075209|NCT00667095|147703700|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.12
74075210|NCT00667095|147703701|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.42
74075211|NCT00667095|147703701|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.15
74075212|NCT00667095|147703702|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 1 month||||0.18
74075213|NCT00667095|147703702|SUPERIORITY_OR_OTHER|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.77
74075214|NCT00667095|147703703|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||Change from baseline to one month||||0.67
74075215|NCT00667095|147703703|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.20
74075216|NCT00667095|147703704|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||Change between baseline and one month||||0.31
74075217|NCT00667095|147703704|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||Change between baseline and 3 months||||0.038
74075218|NCT01832259|147703733|SUPERIORITY|||||||0.345|||||||t-test, 1 sided|||||||0.345
74075219|NCT01832259|147703735|SUPERIORITY|||||||0.46|||||||Log Rank|||||||0.46
74075220|NCT03585790|147703748|NON_INFERIORITY|Margin acceptable mean difference (Single Vision - Multifocal) = -5 rating units (0-100 scale, 0 = optimal)||||||0.18|||||||t-test, 1 sided|||Ho: Single Vision - Multifocal \>= M vs. Ho: Single Vision - Multifocal \< M. Alpha = 0.05, two sided beta = 0.80||||0.18
74075221|NCT00834743|147703749|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.49||||||90.0|90.65|109.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.18|90.65|
74075222|NCT00834743|147703750|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|91.44|107.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.19|91.44|
73884931|NCT00385671|147303856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.304|TWO_SIDED|95.0|-0.25|0.81||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.||0.81|-0.25|0.304
73884932|NCT00385671|147303856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.989|TWO_SIDED|95.0|-0.53|0.54||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: least pain.||0.54|-0.53|0.989
73884933|NCT00385671|147303857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.145|TWO_SIDED|95.0|-0.14|0.97||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.||0.97|-0.14|0.145
74075223|NCT00834743|147703751|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|90.57|108.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.32|90.57|
74075224|NCT04274686|147703767|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.667|TWO_SIDED|95.0|-7.0|10.7|||Paired t-test|||Null hypothesis: No difference in percent air leakage||10.7|-7.0|0.667
73884934|NCT00385671|147303857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.112|TWO_SIDED|95.0|-0.11|1.03||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.||1.03|-0.11|0.112
74075225|NCT04274686|147703768|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.218|TWO_SIDED|95.0|-0.7|2.9|||Paired t-test|||||2.90|-0.70|0.218
74075226|NCT04274686|147703769|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.455|TWO_SIDED|95.0|-0.5|0.2|||Paired t-test|||||0.2|-0.5|0.455
74075227|NCT00376623|147703770|OTHER|A one-sided exact binomial test with a 2.5 % significance level was used to detect the difference between BI 2536 and historical placebo with objective response rate = 0.9 % (two out of 211) with a 95 % confidence interval of 0.2 % to 3 %.||||||0.0548|||||||One-sided exact binomial test|Null hypothesis H0: p \<= 0.009 Alternative hypothesis HA: p \> 0.009||Efficacy of BI 2536 was evaluated by comparing the tumour response rate of the present trial with the tumour response rate published for patients with the same stage of disease treated with placebo. For this, treatment groups 'BI 2536 200 mg' and 'combination of treatment group 50 mg BI 2536 (day 1 - day 3) and 60 mg BI 2536 (day 1 - day 3)' were pooled together and compared to historical placebo.||||0.0548
74075228|NCT00376623|147703771|OTHER||Hazard Ratio (HR)|1.02||||0.92|TWO_SIDED|95.0|0.67|1.55|||Log Rank||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|Exploratory analysis. No formal hypotheses were tested.||1.55|0.67|0.92
74075229|NCT00376623|147703772|OTHER||Hazard Ratio (HR)|1.11||||0.65|TWO_SIDED|95.0|0.7|1.78|||Log Rank||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|Exploratory analysis. No formal hypotheses were tested.||1.78|0.7|0.65
74075230|NCT00376623|147703775|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.94|2.51|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||2.51|0.94|
74075231|NCT00376623|147703776|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.59|1.49|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||1.49|0.59|
74075232|NCT00376623|147703777|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.81|2.01|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||2.01|0.81|
74075233|NCT01054586|147703786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.1||||0.02||95.0|1.26|29.46||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for ART naïve. Not ART naïve is the reference group."|||29.46|1.26|0.02
74075234|NCT01054586|147703787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.12||||0.05||95.0|1.03|16.5||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||16.50|1.03|0.05
74075235|NCT01054586|147703787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.62||||0.68||95.0|0.16|16.27||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||16.27|0.16|0.68
74075236|NCT01054586|147703788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.83||||0.17||95.0|0.65|12.36||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||12.36|0.65|0.17
74075237|NCT01054586|147703788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.85||95.0|0.12|13.33||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||13.33|0.12|0.85
74075238|NCT01054586|147703789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.2||||0.06||95.0|0.94|10.82||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||10.82|0.94|0.06
74075239|NCT01054586|147703789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.96||95.0|0.11|9.83||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||9.83|0.11|0.96
74075240|NCT01054586|147703790|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.57||95.0|0.52|3.31||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||3.31|0.52|0.57
74075241|NCT01054586|147703790|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28||||0.22||95.0|0.04|2.14||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.14|0.04|0.22
74075242|NCT01054586|147703790|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.86||||0.47||95.0|0.35|9.91||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."|||9.91|0.35|0.47
74075243|NCT01054586|147703791|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.48||95.0|0.55|3.55||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||3.55|0.55|0.48
73884935|NCT00385671|147303857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.865|TWO_SIDED|95.0|-0.52|0.62||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||0.62|-0.52|0.865
73884936|NCT00385671|147303858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.263|TWO_SIDED|95.0|-0.26|0.95||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||0.95|-0.26|0.263
73884937|NCT00385671|147303858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.007|TWO_SIDED|95.0|0.24|1.49||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||1.49|0.24|0.007
74075244|NCT01054586|147703791|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.23||95.0|0.03|2.18||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.18|0.03|0.23
74075245|NCT01054586|147703791|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.67||||0.56||95.0|0.29|9.47||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."|||9.47|0.29|0.56
74075246|NCT01054586|147703793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.72||95.0|0.51|2.66||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||2.66|0.51|0.72
74075247|NCT01054586|147703793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27||||0.21||95.0|0.03|2.08||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.08|0.03|0.21
74075248|NCT01054586|147703793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.26||||0.15||95.0|0.74|6.97|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.||6.97|0.74|0.15
74075249|NCT01054586|147703799|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.77||||0.1||95.0|0.79|18.05|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||18.05|0.79|0.10
74075250|NCT01054586|147703800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.53||||0.02||95.0|1.16|5.54||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||5.54|1.16|0.02
74075251|NCT01054586|147703800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.17||||0.05||95.0|1.54|11.27||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||11.27|1.54|0.05
74075252|NCT01054586|147703800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.67||||0.06||95.0|0.97|13.9||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||13.90|0.97|0.06
74075253|NCT01054586|147703801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.68||||0.01||95.0|1.21|5.9||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||5.9|1.21|0.01
74075254|NCT01054586|147703801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.42||||0.0004||95.0|1.61|12.08||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||12.08|1.61|0.0004
74075255|NCT01054586|147703801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.07||||0.11||95.0|0.78|12.03||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||12.03|0.78|0.11
74075256|NCT01054586|147703802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.03||95.0|1.06|4.15||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||4.15|1.06|0.03
74075257|NCT01054586|147703802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.61||||0.05||95.0|1.48|8.81||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||8.81|1.48|0.05
74075258|NCT01054586|147703802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.31||||0.1||95.0|0.85|6.32||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||6.32|0.85|0.10
74075259|NCT01054586|147703803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.12||||0.03||95.0|1.19|22.02|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||22.02|1.19|0.03
74075260|NCT00910663|147703811|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.01||||||90.0|90.01|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.55|90.01|
74075261|NCT00910663|147703812|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.81||||||90.0|100.23|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.45|100.23|
74075262|NCT00910663|147703813|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.35||||||90.0|100.51|106.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.27|100.51|
74075263|NCT02865850|147703814|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.53|-0.1||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.10|-0.53|
74075264|NCT02865850|147703815|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.30 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|0.97|||=|0.995|TWO_SIDED|95.0|0.536|1.761|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.761|0.536|=0.9950
74075265|NCT02865850|147703815|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4877|TWO_SIDED|95.0|0.833|1.113|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 355 and 377 respectively; median time to first event (Q1, Q3) = 46.14 (24.71, 77.14) weeks versus 47.00 (22.43, 74.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.113|0.833|=0.4877
74075266|NCT02865850|147703816|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.34|0.19||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.19|-0.34|
74075267|NCT02865850|147703817|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.8871|TWO_SIDED|95.0|0.618|1.743|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.743|0.618|=0.8871
74075268|NCT02865850|147703817|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4096|TWO_SIDED|95.0|0.84|1.096|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE plus hospitalization for heart failure or thromboembolic event Excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 420 and 449 respectively; median time to first event (Q1, Q3) = 42.07 (21.50, 71.14) weeks versus 45.29 (22.29, 72.43) weeks, respectively.||1.096|0.840|=0.4096
74075269|NCT02865850|147703818|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.36|||=|0.521|TWO_SIDED|95.0|0.67|2.771|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||2.771|0.670|=0.5210
73884938|NCT00385671|147303858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.102|TWO_SIDED|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||1.13|-0.10|0.102
73884939|NCT00385671|147303859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.922|TWO_SIDED|95.0|-0.61|0.55||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||0.55|-0.61|0.922
73884940|NCT00385671|147303859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.195|TWO_SIDED|95.0|-0.2|0.99||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||0.99|-0.20|0.195
73884941|NCT00385671|147303859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.162|TWO_SIDED|95.0|-0.17|1.02||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||1.02|-0.17|0.162
73884942|NCT00385671|147303860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.541|TWO_SIDED|95.0|-0.46|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||0.87|-0.46|0.541
74075270|NCT02865850|147703818|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.5007|TWO_SIDED|95.0|0.795|1.144|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 225 and 242 respectively; median time to first event (Q1, Q3) = 43.29 (21.71, 77.14) weeks versus 45.79 (21.14, 73.86) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.144|0.795|=0.5007
74075271|NCT02865850|147703819|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.1|||=|0.9527|TWO_SIDED|95.0|0.452|2.666|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||2.666|0.452|=0.9527
74075272|NCT02865850|147703819|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.6284|TWO_SIDED|95.0|0.766|1.195|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 150 and 160 respectively; median time to first event (Q1, Q3) = 43.71 (27.43, 77.14) weeks versus 49.29 (24.43, 74.07) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.195|0.766|=0.6284
74075273|NCT02865850|147703820|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.78|||=|0.5115|TWO_SIDED|95.0|0.388|1.555|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.555|0.388|=0.5115
73884943|NCT00385671|147303860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.051|TWO_SIDED|95.0|0.0|1.36||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||1.36|-0.00|0.051
73884944|NCT00385671|147303860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.173|TWO_SIDED|95.0|-0.21|1.15||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||1.15|-0.21|0.173
73884945|NCT00385671|147303861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.451|TWO_SIDED|95.0|-0.4|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with normal work.||0.90|-0.40|0.451
73884946|NCT00385671|147303861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.485|TWO_SIDED|95.0|-0.43|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.||0.90|-0.43|0.485
73884947|NCT00385671|147303861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.969|TWO_SIDED|95.0|-0.68|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.||0.65|-0.68|0.969
73884948|NCT00385671|147303862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.479|TWO_SIDED|95.0|-0.36|0.76||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with relations with other people.||0.76|-0.36|0.479
73884949|NCT00385671|147303862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.301|TWO_SIDED|95.0|-0.27|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.||0.87|-0.27|0.301
74075274|NCT02865850|147703820|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.4878|TWO_SIDED|95.0|0.812|1.118|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 291 and 310 respectively; median time to first event (Q1, Q3) = 50.00 (29.71, 79.00) weeks versus 49.57 (25.86, 77.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.118|0.812|=0.4878
73884950|NCT00385671|147303862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.731|TWO_SIDED|95.0|-0.47|0.67||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.||0.67|-0.47|0.731
73884951|NCT00385671|147303863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.528|TWO_SIDED|95.0|-0.45|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.87|-0.45|0.528
74075275|NCT00252720|147703854|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024||||0.8487|TWO_SIDED|95.0|0.8|1.312|||Log Rank|Generalized||||1.312|0.800|0.8487
74075276|NCT03506386|147703900|OTHER||||||<|0.0001||||||Statistical differences among eligible performed, eligible not performed and not eligible participants were estimated by Log Rank test.|Log Rank|||||||< 0.0001
74075277|NCT01546545|147703961|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation was performed. This was the first pilot and feasibility study. This data will be used to power future studies.||||||0.02|||||||t-test, 2 sided|||||||0.02
74075278|NCT01546545|147703962|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation was performed. This was a pilot and feasibility study.||||||0.02|||||||t-test, 2 sided|||||||0.02
74075279|NCT02979353|147703963|SUPERIORITY||Risk Ratio (RR)|0.96||||0.017|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge timepoint (average 3 days after study enrollment)||||0.017
74075280|NCT02979353|147703963|SUPERIORITY||Risk Ratio (RR)|0.86|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the Post-Acute Care Discharge time point (occurred on average 31 days after study enrollment)||||<0.0001
74075281|NCT02979353|147703963|SUPERIORITY||Risk Ratio (RR)|0.85|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow-Up After PAC Discharge (occurred, on average, 122 days after study enrollment)||||<0.0001
74075282|NCT02979353|147703964|SUPERIORITY||Mean Difference (Net)|-0.28||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 1 applies to the Hospital Discharge time point (occurred, on average, 3 days after study enrollment)||||0.02
74075283|NCT02979353|147703964|SUPERIORITY||Mean Difference (Net)|-0.59|||<|1e-05|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 2 applies to Post-Acute Care Discharge time point (occurred, on average, 31 days after study enrollment).||||<0.00001
74075284|NCT02979353|147703964|SUPERIORITY||Mean Difference (Net)|-0.35||||0.01|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 3 applies to 90-Day Follow Up After PAC Discharge time point (occurred, on average, 122 after study enrollment).||||0.01
74075285|NCT00617305|147703978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-248.93|STANDARD_DEVIATION|241.978|||TWO_SIDED|95.0|-337.7|-160.2||||||Mean change from Baseline to Week 24||-160.2|-337.7|
74075286|NCT00617305|147703978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-291.8|STANDARD_DEVIATION|205.864|||TWO_SIDED|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24||35.78|-619.4|
73888521|NCT05465317|147309655|OTHER||Hazard Ratio (HR)|0.93||||0.69|TWO_SIDED|95.0|0.65|1.33|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.33|0.65|0.69
74075287|NCT00617305|147703978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-253.83|STANDARD_DEVIATION|235.787|||TWO_SIDED|95.0|-334.8|-172.8||||||Mean change from Baseline to Week 24||-172.8|-334.8|
74075288|NCT00617305|147703978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-291.8|STANDARD_DEVIATION|205.864|||TWO_SIDED|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24||35.78|-619.4|
74075289|NCT00617305|147703979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.38|STANDARD_DEVIATION|7.954|||TWO_SIDED|95.0|-8.29|-2.46||||||Mean change from Baseline to Week 24||-2.46|-8.29|
74075290|NCT00617305|147703979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.75|STANDARD_DEVIATION|8.732|||TWO_SIDED|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24||-1.86|-29.64|
74075291|NCT00617305|147703979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.56|STANDARD_DEVIATION|8.589|||TWO_SIDED|95.0|-9.51|-3.61||||||Mean change from Baseline to Week 24||-3.61|-9.51|
74075292|NCT00617305|147703979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.75|STANDARD_DEVIATION|8.732|||TWO_SIDED|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24||-1.86|-29.64|
74075293|NCT00617305|147703980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|4.442|||TWO_SIDED|95.0|-1.69|1.56||||||Mean change from Baseline to Week 24||1.56|-1.69|
74075294|NCT00617305|147703980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_DEVIATION|4.082|||TWO_SIDED|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24||2.50|-10.50|
74075295|NCT00617305|147703980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_DEVIATION|4.527|||TWO_SIDED|95.0|-2.07|1.04||||||Mean change from Baseline to Week 24||1.04|-2.07|
74075296|NCT00617305|147703980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_DEVIATION|4.082|||TWO_SIDED|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24||2.50|-10.50|
74075297|NCT00617305|147703981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84|STANDARD_DEVIATION|1.053|||TWO_SIDED|95.0|0.43|1.25||||||Mean change from Baseline to Week 24||1.25|0.43|
74075298|NCT00617305|147703981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.685|||TWO_SIDED|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24||1.42|-0.77|
74075299|NCT00617305|147703981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78|STANDARD_DEVIATION|1.021|||TWO_SIDED|95.0|0.41|1.15||||||Mean change from Baseline to Week 24||1.15|0.41|
74075300|NCT00617305|147703981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.685|||TWO_SIDED|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24||1.42|-0.77|
74075301|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.2|STANDARD_DEVIATION|44.84|||TWO_SIDED|95.0|-3.9|28.4||||||Mean change from Baseline to Week 4 (LOCF)||28.4|-3.9|
74075302|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.8|STANDARD_DEVIATION|21.19|||TWO_SIDED|95.0|-26.0|41.5||||||Mean change from Baseline to Week 4 (LOCF)||41.5|-26.0|
74075303|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|107.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
74075304|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.7|STANDARD_DEVIATION|42.68|||TWO_SIDED|95.0|-2.7|26.2||||||Mean change from Baseline to Week 4 (LOCF)||26.2|-2.7|
74075305|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.6|STANDARD_DEVIATION|48.03|||TWO_SIDED|95.0|-32.0|87.2||||||Mean change from Baseline to Week 4 (LOCF)||87.2|-32.0|
74075306|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.6|STANDARD_DEVIATION|41.46|||TWO_SIDED|95.0|-1.4|28.5||||||Mean change from Baseline to Week 12 (LOCF)||28.5|-1.4|
74075307|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_DEVIATION|59.09|||TWO_SIDED|95.0|-91.5|96.5||||||Mean change from Baseline to Week 12 (LOCF)||96.5|-91.5|
74075308|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
74075309|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.4|STANDARD_DEVIATION|42.83|||TWO_SIDED|95.0|-2.1|26.9||||||Mean change from Baseline to Week 12 (LOCF)||26.9|-2.1|
74075310|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.4|STANDARD_DEVIATION|63.61|||TWO_SIDED|95.0|-59.6|98.4||||||Mean change from Baseline to Week 12 (LOCF)||98.4|-59.6|
74075311|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.1|STANDARD_DEVIATION|48.67|||TWO_SIDED|95.0|0.5|35.6||||||Mean change from Baseline to Week 24 (LOCF)||35.6|0.5|
74075312|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.5|STANDARD_DEVIATION|29.56|||TWO_SIDED|95.0|-56.5|37.5||||||Mean change from Baseline to Week 24 (LOCF)||37.5|-56.5|
74075313|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
74075314|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0|STANDARD_DEVIATION|47.44|||TWO_SIDED|95.0|-1.0|31.1||||||Mean change from Baseline to Week 24 (LOCF)||31.1|-1.0|
74075315|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.8|STANDARD_DEVIATION|50.18|||TWO_SIDED|95.0|-52.5|72.1||||||Mean change from Baseline to Week 24 (LOCF)||72.1|-52.5|
74075316|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_DEVIATION|77.24|||TWO_SIDED|95.0|-25.6|30.1||||||Mean change from Baseline to Week 36 (LOCF)||30.1|-25.6|
74075317|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.0|STANDARD_DEVIATION|93.16|||TWO_SIDED|95.0|-182.2|114.2||||||Mean change from Baseline to Week 36 (LOCF)||114.2|-182.2|
74075318|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|67.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
74075319|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|78.5|||TWO_SIDED|95.0|-28.4|24.8||||||Mean change from Baseline to Week 36 (LOCF)||24.8|-28.4|
74075320|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.8|STANDARD_DEVIATION|92.46|||TWO_SIDED|95.0|-128.6|101.0||||||Mean change from Baseline to Week 36 (LOCF)||101.0|-128.6|
74075321|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.6|STANDARD_DEVIATION|82.07|||TWO_SIDED|95.0|-15.0|44.2||||||Mean change from Baseline to Week 48 (LOCF)||44.2|-15.0|
74075322|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.8|STANDARD_DEVIATION|126.75|||TWO_SIDED|95.0|-251.4|151.9||||||Mean change from Baseline to Week 48 (LOCF)||151.9|-251.4|
74075323|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|67.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
74075324|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.4|STANDARD_DEVIATION|88.11|||TWO_SIDED|95.0|-22.4|37.3||||||Mean change from Baseline to Week 48 (LOCF)||37.3|-22.4|
74075325|NCT00617305|147703982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.4|STANDARD_DEVIATION|121.55|||TWO_SIDED|95.0|-177.3|124.5||||||Mean change from Baseline to Week 48 (LOCF)||124.5|-177.3|
74075326|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|-1.1|0.0||||||Mean change from Baseline to Week 4 (LOCF)||0.0|-1.1|
74075327|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|-1.6|3.1||||||Mean change from Baseline to Week 4 (LOCF)||3.1|-1.6|
74075328|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
74075329|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.54|||TWO_SIDED|95.0|-0.9|0.1||||||Mean change from Baseline to Week 4 (LOCF)||0.1|-0.9|
73884952|NCT00385671|147303863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.626|TWO_SIDED|95.0|-0.84|0.51||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.51|-0.84|0.626
73884953|NCT00385671|147303863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.27|TWO_SIDED|95.0|-1.06|0.3||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.30|-1.06|0.270
73884954|NCT00385671|147303864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.098|TWO_SIDED|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||1.13|-0.10|0.098
73884955|NCT00385671|147303864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.383|TWO_SIDED|95.0|-0.35|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||0.90|-0.35|0.383
73884956|NCT00385671|147303864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.452|TWO_SIDED|95.0|-0.86|0.39||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||0.39|-0.86|0.452
73884957|NCT00385671|147303865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.309|TWO_SIDED|95.0|-0.26|0.82||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.82|-0.26|0.309
73884958|NCT00385671|147303865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.174|TWO_SIDED|95.0|-0.17|0.93||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.93|-0.17|0.174
73884959|NCT00385671|147303865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.717|TWO_SIDED|95.0|-0.45|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.65|-0.45|0.717
74075330|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_DEVIATION|1.52|||TWO_SIDED|95.0|-1.5|2.3||||||Mean change from Baseline to Week 4 (LOCF)||2.3|-1.5|
74075331|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.45|||TWO_SIDED|95.0|-1.1|0.0||||||Mean change from Baseline to Week 12 (LOCF)||0.0|-1.1|
74075332|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.38|||TWO_SIDED|95.0|-2.3|5.3||||||Mean change from Baseline to Week 12 (LOCF)||5.3|-2.3|
74075333|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
74075334|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|1.67|||TWO_SIDED|95.0|-0.9|0.2||||||Mean change from Baseline to Week 12 (LOCF)||0.2|-0.9|
74075335|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.17|||TWO_SIDED|95.0|-1.5|3.9||||||Mean change from Baseline to Week 12 (LOCF)||3.9|-1.5|
74075336|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|1.81|||TWO_SIDED|95.0|-1.5|-0.2||||||Mean change from Baseline to Week 24 (LOCF)||-0.2|-1.5|
74075337|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.75|||TWO_SIDED|95.0|-1.8|0.6||||||Mean change from Baseline to Week 24 (LOCF)||0.6|-1.8|
74075338|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
74075339|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.72|||TWO_SIDED|95.0|-1.4|-0.3||||||Mean change from Baseline to Week 24 (LOCF)||-0.3|-1.4|
74075340|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|0.71|||TWO_SIDED|95.0|-1.4|0.4||||||Mean change from Baseline to Week 24 (LOCF)||0.4|-1.4|
74075341|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.79|||TWO_SIDED|95.0|-1.2|0.1||||||Mean change from Baseline to Week 36 (LOCF)||0.1|-1.2|
74075342|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|-2.2|4.2||||||Mean change from Baseline to Week 36 (LOCF)||4.2|-2.2|
74075343|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
74075344|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.85|||TWO_SIDED|95.0|-1.0|0.2||||||Mean change from Baseline to Week 36 (LOCF)||0.2|-1.0|
74075345|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|1.79|||TWO_SIDED|95.0|-1.4|3.0||||||Mean change from Baseline to Week 36 (LOCF)||3.0|-1.4|
74075346|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|2.12|||TWO_SIDED|95.0|-1.4|0.1||||||Mean change from Baseline to Week 48 (LOCF)||0.1|-1.4|
74075347|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|3.46|||TWO_SIDED|95.0|-4.5|6.5||||||Mean change from Baseline to Week 48 (LOCF)||6.5|-4.5|
74075348|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
74075349|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|2.3|||TWO_SIDED|95.0|-1.3|0.3||||||Mean change from Baseline to Week 48 (LOCF)||0.3|-1.3|
74075350|NCT00617305|147703983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|3.03|||TWO_SIDED|95.0|-3.0|4.6||||||Mean change from Baseline to Week 48 (LOCF)||4.6|-3.0|
74075351|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_DEVIATION|3.98|||TWO_SIDED|95.0|-2.7|0.4||||||Mean change from Baseline to Week 12 (LOCF)||0.4|-2.7|
74075352|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|4.86|||TWO_SIDED|95.0|-6.5|9.0||||||Mean change from Baseline to Week 12 (LOCF)||9.0|-6.5|
74075353|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
74075354|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.09|||TWO_SIDED|95.0|-2.3|0.6||||||Mean change from Baseline to Week 12 (LOCF)||0.6|-2.3|
74075355|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|4.45|||TWO_SIDED|95.0|-4.9|6.1||||||Mean change from Baseline to Week 12 (LOCF)||6.1|-4.9|
74075356|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|5.0|||TWO_SIDED|95.0|-2.7|1.1||||||Mean change from Baseline to Week 24 (LOCF)||1.1|-2.7|
74075357|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|4.03|||TWO_SIDED|95.0|-7.7|5.2||||||Mean change from Baseline to Week 24 (LOCF)||5.2|-7.7|
74075358|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
74075359|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|4.84|||TWO_SIDED|95.0|-2.6|0.9||||||Mean change from Baseline to Week 24 (LOCF)||0.9|-2.6|
74075360|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|3.51|||TWO_SIDED|95.0|-5.8|3.0||||||Mean change from Baseline to Week 24 (LOCF)||3.0|-5.8|
74075361|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|5.2|||TWO_SIDED|95.0|-2.3|1.7||||||Mean change from Baseline to Week 36 (LOCF)||1.7|-2.3|
74075362|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.65|||TWO_SIDED|95.0|-8.1|6.6||||||Mean change from Baseline to Week 36 (LOCF)||6.6|-8.1|
74075363|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
74075364|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|5.07|||TWO_SIDED|95.0|-2.2|1.5||||||Mean change from Baseline to Week 36 (LOCF)||1.5|-2.2|
74075365|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.02|||TWO_SIDED|95.0|-5.8|4.2||||||Mean change from Baseline to Week 36 (LOCF)||4.2|-5.8|
74075366|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|6.33|||TWO_SIDED|95.0|-2.8|2.1||||||Mean change from Baseline to Week 48 (LOCF)||2.1|-2.8|
74075367|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|6.86|||TWO_SIDED|95.0|-11.4|10.4||||||Mean change from Baseline to Week 48 (LOCF)||10.4|-11.4|
74075368|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
74075369|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|6.28|||TWO_SIDED|95.0|-2.7|1.9||||||Mean change from Baseline to Week 48 (LOCF)||1.9|-2.7|
74075370|NCT00617305|147703984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|5.94|||TWO_SIDED|95.0|-8.0|6.8||||||Mean change from Baseline to Week 48 (LOCF)||6.8|-8.0|
74075371|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.5||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
74075372|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
74075373|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.49||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
74075374|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
74075375|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.63||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
74075376|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
74075377|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.64||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
74075378|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
74075379|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.83||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
74075380|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
74075381|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.81||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
74075382|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
74075383|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.92||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
74075384|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
74075385|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.91||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
74075386|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
74075387|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.91||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
74075388|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
74075389|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.88||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
74075390|NCT00617305|147703986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
74075391|NCT03897088|147704001|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
74075392|NCT03897088|147704010|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
74075393|NCT03897088|147704011|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
74075394|NCT03897088|147704012|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
74075395|NCT03897088|147704013|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
74075396|NCT03897088|147704014|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
73884960|NCT00385671|147303866|SUPERIORITY_OR_OTHER|||||||0.975||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.975
73884961|NCT00385671|147303866|SUPERIORITY_OR_OTHER|||||||0.448||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.448
73884962|NCT00385671|147303866|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.280
74075397|NCT03897088|147704015|SUPERIORITY||||||<|1e-05||||||Log Rank Test p-Value|Kaplan-Meier Estimates|||||||<0.00001
74075398|NCT03897088|147704016|SUPERIORITY||||||<|1e-05||||||Log Rank Test p-Value|Kaplan-Meier Estimates|||||||<0.00001
74075399|NCT03897088|147704017|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||||||<0.00001
74075400|NCT03897088|147704018|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||PASI-75||||<0.00001
74075401|NCT03897088|147704018|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||PASI-90||||<0.00001
74075402|NCT03897088|147704018|SUPERIORITY|||||||4e-05|||||||Cochran-Mantel-Haenszel|||PASI-100||||0.00004
74075403|NCT03897088|147704019|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
74075404|NCT03897088|147704020|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
74075405|NCT03897088|147704021|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
74075406|NCT03897088|147704022|SUPERIORITY||||||<|1e-05||||||Week 16|Cochran-Mantel-Haenszel|||||||<0.00001
74075407|NCT03897088|147704023|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 12||||<0.00001
74075408|NCT03897088|147704024|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 12||||<0.00001
74075409|NCT00855738|147704033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3: p-value versus baseline.||||<0.0001
74075410|NCT00855738|147704033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||<0.0001
74075411|NCT00855738|147704034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3 \>=25% reduction: p-value versus baseline.||||<0.0001
74075412|NCT00855738|147704034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3 \>=75% reduction: p-value versus baseline.||||<0.0001
74075413|NCT00855738|147704034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: \>=25% reduction: p-value versus baseline.||||<0.0001
74075414|NCT00855738|147704034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: \>=75% reduction: p-value versus baseline.||||<0.0001
74075415|NCT00855738|147704035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0039|TWO_SIDED||||||McNemar|||Month 3: p-value versus baseline.||||0.0039
74075416|NCT00855738|147704035|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||<0.0001
74075417|NCT00855738|147704036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
74075418|NCT00855738|147704047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1797|TWO_SIDED||||||t-test, 2 sided|||Depression domain: P-value vs baseline.||||0.1797
74075419|NCT00855738|147704047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0433|TWO_SIDED||||||t-test, 2 sided|||Anxiety domain: P-value vs baseline.||||0.0433
74075420|NCT00855738|147704048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8284|TWO_SIDED||||||t-test, 2 sided|||Energy: p-value versus baseline.||||0.8284
74075421|NCT00855738|147704048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6299|TWO_SIDED||||||t-test, 2 sided|||Emotions (mood): p-value versus baseline.||||0.6299
74075422|NCT00855738|147704048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6162|TWO_SIDED||||||t-test, 2 sided|||Daily activities: p-value versus baseline.||||0.6162
74075423|NCT00855738|147704048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609|TWO_SIDED||||||t-test, 2 sided|||Mental function: p-value versus baseline.||||0.5609
74075424|NCT00855738|147704048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4635|TWO_SIDED||||||t-test, 2 sided|||Medication effects (physical/ mental): p-value versus baseline.||||0.4635
74075425|NCT00855738|147704048|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Worry about seizures (impact of seizures): p-value versus baseline.||||<0.0001
74075426|NCT00855738|147704048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0258|TWO_SIDED||||||t-test, 2 sided|||Overall quality of life: p-value versus baseline.||||0.0258
74075427|NCT00855738|147704049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7822|TWO_SIDED||||||t-test, 2 sided|||Month 3: p-value versus baseline.||||0.7822
74075428|NCT00855738|147704049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4471|TWO_SIDED||||||t-test, 2 sided|||Month 6: p-value versus baseline.||||0.4471
74075429|NCT00855738|147704050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2452|TWO_SIDED||||||t-test, 2 sided|||Sleep disturbance: p-value versus baseline.||||0.2452
74075430|NCT00855738|147704050|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Snoring: p-value verus baseline.||||1.0000
73884963|NCT00385671|147303867|SUPERIORITY_OR_OTHER|||||||0.548||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||0.548
74075431|NCT00855738|147704050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4253|TWO_SIDED||||||t-test, 2 sided|||Awake short of breath: p-value versus baseline.||||0.4253
74075432|NCT00855738|147704050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0572|TWO_SIDED||||||t-test, 2 sided|||Quantity: p-value versus baseline.||||0.0572
74075433|NCT00855738|147704050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0625|TWO_SIDED||||||t-test, 2 sided|||Adequacy: p-value versus baseline.||||0.0625
74075434|NCT00855738|147704050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.554|TWO_SIDED||||||t-test, 2 sided|||Somnolence: p-value versus baseline.||||0.5540
74075435|NCT00855738|147704050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4204|TWO_SIDED||||||t-test, 2 sided|||Sleep problems (summary 6): p-value versus baseline.||||0.4204
74075436|NCT00855738|147704050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869|TWO_SIDED||||||t-test, 2 sided|||Sleep problems (summary 9): p-value versus baseline.||||0.4869
74075437|NCT00855738|147704051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0863|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||0.0863
74075438|NCT00855738|147704052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0226|TWO_SIDED||||||t-test, 2 sided|||Number of visits to a specialist because of epilepsy: p-value versus baseline.||||0.0226
74075439|NCT00855738|147704052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|TWO_SIDED||||||t-test, 2 sided|||Number of visits to the emergency room because of epilepsy: p-value versus baseline.||||0.0017
74075440|NCT00855738|147704053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3141|TWO_SIDED||||||t-test, 2 sided|||P-value versus baseline.||||0.3141
74075441|NCT00855738|147704054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0708|TWO_SIDED||||||t-test, 2 sided|||Cessation of usual occupation: p-value versus baseline.||||0.0708
74075442|NCT00855738|147704054|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Requirement of informal caregiver: p-value versus baseline.||||1.0000
74075443|NCT00855738|147704054|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Required admission to ICU: p-value versus baseline.||||1.0000
74075444|NCT01811953|147704057|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.55|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|99.531|105.653|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||105.653|99.531|<0.0001
74075445|NCT01811953|147704057|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.88|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.879|103.059|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.059|94.879|<0.0001
74075446|NCT01811953|147704057|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.0|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|102.728|109.386|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.386|102.728|<0.0001
74075447|NCT01811953|147704058|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|96.13|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|91.25|101.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||101.26|91.25|<0.0001
74075448|NCT01811953|147704058|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.34|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.56|106.62|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||106.62|92.56|<0.0001
74075449|NCT01811953|147704058|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean difference|100.81|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|95.74|106.14|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||106.14|95.74|<0.0001
74075450|NCT01811953|147704059|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.33|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|99.315|105.43|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||105.430|99.315|<0.0001
73884964|NCT00385671|147303867|SUPERIORITY_OR_OTHER|||||||0.599||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||0.599
74075451|NCT01811953|147704059|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.82|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.784|103.037|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.037|94.784|<0.0001
74075452|NCT01811953|147704059|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|105.98|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|102.73|109.329|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.329|102.730|<0.0001
74075453|NCT01811953|147704060|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.12|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|96.255|108.351|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||108.351|96.255|<0.0001
74075454|NCT01811953|147704060|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.52|STANDARD_ERROR_OF_MEAN|1.063||0.0082|TWO_SIDED|90.0|95.863|118.353|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||118.353|95.863|0.0082
74075455|NCT01811953|147704060|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|104.352|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.152|110.224|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||110.224|99.152|<0.0001
74075456|NCT01811953|147704061|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.87|STANDARD_ERROR_OF_MEAN|1.038||0.0001|TWO_SIDED|90.0|88.931|101.21|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||101.210|88.931|0.0001
74075457|NCT01811953|147704061|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|97.97|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|92.339|103.935|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.935|92.339|<0.0001
74075458|NCT01811953|147704061|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.95|STANDARD_ERROR_OF_MEAN|1.034|<|0.0001|TWO_SIDED|90.0|97.166|109.082|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.082|97.166|<0.0001
74075459|NCT01811953|147704062|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.89|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|89.8|100.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||100.26|89.80|<0.0001
74075460|NCT01811953|147704062|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.31|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.14|107.03|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||107.03|92.14|<0.0001
74075461|NCT01811953|147704062|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|100.74|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|95.77|105.96|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||105.96|95.77|<0.0001
74075462|NCT02262377|147704065|SUPERIORITY|The ITT analysis was done for 21 week average pain.|Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.92|1.15||Statistical significance was set at p\< 0.05.|Regression, Poisson|||Intention to Treat Analysis for average chronic pain.||1.15|0.92|0.68
74075463|NCT02262377|147704065|SUPERIORITY|The ITT analysis was done for 21 week BPI Interference.|Risk Ratio (RR)|0.98||||0.36|TWO_SIDED|95.0|0.88|1.08||Statistical significance was set at p\< 0.05.|Regression, Poisson|||||1.08|0.88|0.36
74075464|NCT02262377|147704065|SUPERIORITY|The ITT analysis was done for 21 week BPI Severity.|Risk Ratio (RR)|1.0||||0.996|TWO_SIDED|95.0|0.86|1.16||Statistical significance was set at p\< 0.05.|Regression, Poisson|||||1.16|0.86|0.996
74075465|NCT02262377|147704066|SUPERIORITY||Risk Ratio (RR)|1.17||||0.054|TWO_SIDED|95.0|0.99|1.37|||Regression, Poisson|||||1.37|0.99|0.054
74075466|NCT02262377|147704067|SUPERIORITY||Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.89|1.13|||Regression, Poisson|||||1.13|0.89|0.98
74075467|NCT02262377|147704068|SUPERIORITY||Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.18|0.98|||Odds Ratio|||||0.98|0.18|
74075468|NCT02262377|147704069|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.9|1.14|||Odds Ratio|||||1.14|0.90|
74075469|NCT00723528|147704074|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact|||||||<0.0001
74075470|NCT00723528|147704075|SUPERIORITY_OR_OTHER||||||<|0.0001||||||2-sample t-test (using Holm's method)|t-test, 2 sided|||||||<0.0001
74075471|NCT00723528|147704085|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact|||||||<0.0001
74075472|NCT01993030|147704087|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Growth of Granulation Tissue between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with healthy granulation tissue and the Participants with unhealthy granulation tissue category."||||0.49
74075473|NCT01993030|147704088|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Inflammatory Reaction between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with Inflammatory Reaction and the Participants without Inflammatory Reaction category."||||0.36
74075474|NCT01993030|147704089|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the VAS score between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.||||0.11
74075475|NCT01993030|147704090|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Exudation between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to No exudation and Little exudation category."||||0.11
74075476|NCT01993030|147704091|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the Time to Wound Healing between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.||||0.02
74075477|NCT01710657|147704092|SUPERIORITY_OR_OTHER||% Reduction over Placebo|39.6|||<|0.001|TWO_SIDED|95.0|30.5|47.6||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."||47.6|30.5|<0.001
74075478|NCT01710657|147704092|SUPERIORITY_OR_OTHER||% Reduction over Placebo|29.4|||<|0.001|TWO_SIDED|95.0|18.7|38.7||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."||38.7|18.7|< 0.001
74075479|NCT01591785|147704112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED||||||Chi-squared|||||||0.035
74075480|NCT01591785|147704113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|TWO_SIDED||||||Chi-squared|||||||0.28
74075481|NCT01591785|147704114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0495|TWO_SIDED||||||Chi-squared|||||||0.0495
74075482|NCT01591785|147704115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|TWO_SIDED||||||Chi-squared|||||||0.27
74075483|NCT00905346|147704142|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|98.39||||||90.0|94.36|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.59|94.36|
73884965|NCT00385671|147303867|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||1.00
73884966|NCT00385671|147303868|SUPERIORITY_OR_OTHER|||||||0.905||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.905
73884967|NCT00385671|147303868|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.368
74075484|NCT00905346|147704143|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.92||||||90.0|99.88|106.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.05|99.88|
74075485|NCT00905346|147704144|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.63||||||90.0|99.24|106.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.14|99.24|
74075486|NCT00909610|147704150|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.3|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125|||111|92.3|
74075487|NCT00909610|147704151|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|106.0||||||90.0|101.0|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|101|
74075488|NCT00909610|147704152|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|101.0||||||90.0|91.9|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|91.9|
74075489|NCT00909610|147704153|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|105.0||||||90.0|100.0|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|100|
74075490|NCT00909610|147704154|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.5|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.5|
74075491|NCT00909610|147704155|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||117|103|
74075492|NCT00909610|147704156|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.2|
73888522|NCT05465317|147309655|OTHER||Hazard Ratio (HR)|0.93||||0.82|TWO_SIDED|95.0|0.51|1.7|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.70|0.51|0.82
74075493|NCT00909610|147704157|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||115|100|
74075494|NCT01969747|147704176|SUPERIORITY_OR_OTHER||Adjusted mean|76.09|STANDARD_ERROR_OF_MEAN|8.77|<|0.0001|TWO_SIDED|95.0|58.6|93.59|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 2.5 mg with Placebo||93.59|58.60|<0.0001
74075495|NCT01969747|147704176|SUPERIORITY_OR_OTHER||Adjusted mean|106.39|STANDARD_ERROR_OF_MEAN|8.85|<|0.0001|TWO_SIDED|95.0|88.73|124.05|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 10 mg with Placebo||124.05|88.73|<0.0001
74075496|NCT01969747|147704176|SUPERIORITY_OR_OTHER||Adjusted mean|104.81|STANDARD_ERROR_OF_MEAN|8.99|<|0.0001|TWO_SIDED|95.0|86.88|122.74|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 25 mg with Placebo||122.74|86.88|<0.0001
74075497|NCT04000815|147704177|OTHER||||||<|0.017||||||p-value is adjusted for multiple comparisons|Kruskal-Wallis|||||||<0.017
74075498|NCT04000815|147704178|OTHER||||||<|0.05|||||||Bi-variate correlation analysis|Bi-variate correlation analyses were performed in groups 1 and 2 between serum CNP and FSH and between serum CNP and LH using Spearman test.||||||<0.05
74075499|NCT04000815|147704179|OTHER||||||<|0.05|||||||Bi-variate correlation|Spearman test was applied.||||||<0.05
74075500|NCT04000815|147704180|OTHER||||||<|0.05|||||||Bi-variate correlation analyses|Bi-variate correlation analyses were performed for all subjects in groups 1 and 2 between serum CNP and E2 using Spearman test.||||||<0.05
74075501|NCT03988803|147704220|OTHER||Ratio of the geometric means (T/R1)|94.8|STANDARD_ERROR_OF_MEAN|12.2|||TWO_SIDED|90.0|87.14|103.14|||ANOVA||Standard error of the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||103.14|87.14|
74075502|NCT03988803|147704221|OTHER||Ratio of the geometric means (T/R1)|99.34|STANDARD_ERROR_OF_MEAN|12.3|||TWO_SIDED|90.0|91.22|108.18|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||108.18|91.22|
74075503|NCT03988803|147704222|OTHER||Ratio of the geometric means (T/R2)|103.69|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|99.99|107.52|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||107.52|99.99|
74075504|NCT03988803|147704223|OTHER||Ratio of the geometric means (T/R2)|107.45|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|90.0|102.66|112.45|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||112.45|102.66|
74075505|NCT00840099|147704235|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of Means x 100|100.91||||||90.0|95.82|106.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.26|95.82|
74075506|NCT00840099|147704236|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.79||||||90.0|100.69|104.94|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.94|100.69|
74075507|NCT00840099|147704237|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.75||||||90.0|100.62|104.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.93|100.62|
74075508|NCT00840099|147704238|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the Mean x 100|100.47||||||90.0|93.28|108.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.20|93.28|
74075509|NCT00840099|147704239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Ratio of the mean|104.15||||||90.0|96.35|112.58|||||Bioequivalence is established when 80% Confidence Interval falls within 80 - 125|||112.58|96.35|
74075510|NCT00840099|147704240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|104.06||||||90.0|95.85|112.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.97|95.85|
74075511|NCT01032083|147704260|EQUIVALENCE|For the primary outcome, linear regression was used to determine mean difference between treatment groups. Differences between groups are presented as mean differences with associated 95% confidence interval (CI). Baseline values for variables were included as covariates in regression models and adjusted according to analysis of covariance. All analyses were conducted under the intention-to-treat principle.|Mean Difference (Final Values)|-1.54||||0.36|TWO_SIDED|95.0|-4.91|1.8|||Regression, Linear|||||1.80|-4.91|0.36
74075512|NCT01032083|147704261|EQUIVALENCE|For the primary outcome, linear regression was used to determine mean difference between treatment groups. Differences between groups are presented as mean differences with associated 95% confidence interval (CI). Baseline values for variables were included as covariates in regression models and adjusted according to analysis of covariance. All analyses were conducted under the intention-to-treat principle.|Mean Difference (Final Values)|2.4||||0.68|TWO_SIDED|95.0|-9.0|14.0|||Regression, Linear|||||14|-9|0.68
74075513|NCT00829530|147704356|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|88.87||||||90.0|80.31|98.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.34|80.31|
74075514|NCT00829530|147704357|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|94.96||||||90.0|89.77|100.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.45|89.77|
73884968|NCT00385671|147303868|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.200
73884969|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.||||0.572
73884970|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 weeks in LSEQ GTS scores.||||0.345
74075515|NCT00829530|147704358|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|95.24||||||90.0|90.13|100.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.63|90.13|
74075516|NCT00829530|147704359|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.85||||||90.0|91.95|106.27|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.27|91.95|
74075517|NCT00829530|147704360|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.62||||||90.0|97.8|103.52|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.52|97.8|
73884971|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.||||0.699
73884972|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.||||0.954
74075518|NCT00840866|147704361|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.0|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109|99|
74075519|NCT00840866|147704362|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.9||||||90.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|98.6|
74075520|NCT00840866|147704363|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|98.5|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|98.5|
74075521|NCT01015625|147704364|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|1.77||||0.042|TWO_SIDED|95.0|1.01|3.09|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter overall survival time for surgery relative to no surgery.|To determine the effect of local therapy (surgery, Arm A) compared to systemic therapy only (Arm B) in synchronous metastasized breast cancer patients in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause. Participants last known to be alive were censored at their last contact date or at the data cut-off date whichever came first.||3.09|1.01|0.042
74075522|NCT01015625|147704365|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|1.45||||0.147|TWO_SIDED|95.0|0.87|2.42|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter time to distant progression for surgery relative to no surgery.|To determine the effect of local therapy (surgery) compared to systemic therapy only in synchronous metastasized breast cancer patients in terms of time from randomization to distant progression. Distant progression is defined as detection of new lesions or progression of existing metastases in locations different then breast. Participants last known to be alive without a distant progression were censored at their last contact date or at the data cut-off date whichever came first.||2.42|0.87|0.147
74075523|NCT01015625|147704366|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|0.95||||0.89|TWO_SIDED|95.0|0.45|2.02|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter time to local progression for surgery relative to no surgery.|To determine the effect of local therapy (surgery) compared to systemic therapy only in synchronous metastasized breast cancer patients in terms of time from randomization to local progression. Local progression is defined as recurrence in breast with localization mamma, chest wall or axilla. Participants last known to be alive, who did not experience a local progression were censored at their last contact date or at the data cut-off date whichever came first.||2.02|0.45|0.890
74075524|NCT04112823|147704367|SUPERIORITY||Risk Ratio (RR)|7.0|||||TWO_SIDED|95.0|-6.0|20.0||||||||20|-6|
74075525|NCT04112823|147704368|SUPERIORITY||Risk Ratio (RR)|4.0|||||TWO_SIDED|95.0|-8.0|16.0||||||||16|-8|
74075526|NCT04112823|147704369|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|-8.0|14.0||||||||14|-8|
74075527|NCT04112823|147704371|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.3|1.2||||||||1.2|-0.3|
74075528|NCT04112823|147704372|SUPERIORITY||Risk Ratio (RR)|4.0|||||TWO_SIDED|95.0|-9.0|18.0||||||||18|-9|
74075529|NCT02728102|147704388|SUPERIORITY||difference in the proportions|2.9||||0.3657|TWO_SIDED|80.0|-8.8|14.6||A one-sided significance level of 0.10 is used to assess whether the vaccine appears promising relative to control.|Z test|||The proportion of patients alive and in CR/sCR at 1 year post transplant will be described in the vaccine and no vaccine groups with 80% confidence intervals and compared between groups using a two-sample Z test comparing binomial proportions.||14.6|-8.8|0.3657
74075530|NCT02728102|147704388|EQUIVALENCE|The stratified odds ratio is estimated with 80% confidence intervals.|Odds Ratio (OR)|1.19||||0.7461|TWO_SIDED|80.0|0.7|2.03||P-value is provided by Breslow-Day Test for Homogeneity of the Odds Ratios.|Cochran-Mantel-Haenszel||The Cochran-Mantel-Haenszel Odds Ratio estimate is for the Stratification. Stratum 1 is sCR/CR at Randomization. Stratum 2 is VGPR/PR/Stable Response at Randomization.|A secondary analysis stratified on disease response prior to randomization between arms will be conducted using a Cochran-Mantel-Haenszel test, and a stratified odds ratio along with 80% confidence intervals will be estimated.||2.03|0.70|0.7461
74075531|NCT02728102|147704388|SUPERIORITY|The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide/GM-CSF arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.|difference in the proportions|7.2||||0.2429|TWO_SIDED|80.0|-6.4|20.6|||Z test|||A secondary pairwise analysis of CR/sCR rates comparing the vaccine arm to Lenalidomide/GM-CSF arm at 1 year post transplant.||20.6|-6.4|0.2429
74075532|NCT02728102|147704388|SUPERIORITY|The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide alone arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.|difference in the proportions|-1.6||||0.4397|TWO_SIDED|80.0|-15.6|12.4|||Z test|||A secondary pairwise analysis of CR rates comparing the vaccine arm to Lenalidomide alone arm at 1 year post transplant.||12.4|-15.6|0.4397
74075533|NCT02728102|147704389|SUPERIORITY|||||||0.9376||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.||||0.9376
74075534|NCT02728102|147704389|SUPERIORITY|||||||0.4887||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 6 months Post Transplant.||||0.4887
74075535|NCT02728102|147704389|SUPERIORITY|||||||0.5176||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 6 months Post Transplant.||||0.5176
74075536|NCT02728102|147704389|SUPERIORITY|||||||0.2461||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between lenalidomide/GM-CSF arm and lenalidomide alone arm at 6 months Post Transplant.||||0.2461
74075537|NCT02728102|147704389|SUPERIORITY|||||||0.253||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 1 year Post Transplant.||||0.2530
74075538|NCT02728102|147704389|SUPERIORITY|||||||0.2213||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 1 year Post Transplant.||||0.2213
74075539|NCT02728102|147704389|SUPERIORITY|||||||0.493||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 1 year Post Transplant.||||0.4930
74075540|NCT02728102|147704389|SUPERIORITY|||||||0.6591||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 1 year Post Transplant.||||0.6591
74075541|NCT02728102|147704389|SUPERIORITY|||||||0.679||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 2 years Post Transplant.||||0.6790
74075542|NCT02728102|147704389|SUPERIORITY|||||||0.3124||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 2 years Post Transplant.||||0.3124
74075543|NCT02728102|147704389|SUPERIORITY|||||||0.7379||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 2 years Post Transplant.||||0.7379
74075544|NCT02728102|147704389|SUPERIORITY|||||||0.2379||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 2 years Post Transplant.||||0.2379
74075545|NCT02728102|147704389|SUPERIORITY|||||||0.5353||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.||||0.5353
74075546|NCT02728102|147704389|SUPERIORITY|||||||0.4417||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 12 months Post Transplant.||||0.4417
74075547|NCT02728102|147704389|SUPERIORITY|||||||0.945||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 24 months Post Transplant.||||0.9450
74075548|NCT02728102|147704389|SUPERIORITY|||||||0.1599||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine arm and lenalidomide/GM-CSF arm is conducted at 1 year post transplant.||||0.1599
74075549|NCT02728102|147704389|SUPERIORITY|||||||0.8984||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine arm and lenalidomide alone arm is conducted at 1 year post transplant.||||0.8984
74075550|NCT02728102|147704389|SUPERIORITY|||||||0.1757||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between lenalidomide/GM-CSF arm and lenalidomide alone arm is conducted at 1 year post transplant.||||0.1757
74075551|NCT02728102|147704390|SUPERIORITY|||||||0.161||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between vaccine vs. non- vaccine arms.||||0.161
74075552|NCT02728102|147704391|SUPERIORITY|||||||0.116||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the vaccine arm and lenalidomide/GM-CSF arm.||||0.116
74075553|NCT02728102|147704391|SUPERIORITY|||||||0.519||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the vaccine arm and lenalidomide alone arm.||||0.519
74075554|NCT02728102|147704391|SUPERIORITY|||||||0.387||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.387
74075555|NCT02728102|147704393|SUPERIORITY|||||||0.168||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between vaccine vs. non- vaccine arms.||||0.168
74075556|NCT02728102|147704394|SUPERIORITY|||||||0.12||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the vaccine arm and lenalidomide/GM-CSF arm.||||0.120
74075557|NCT02728102|147704394|SUPERIORITY|||||||0.519||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the vaccine arm and lenalidomide alone arm.||||0.519
74075558|NCT02728102|147704394|SUPERIORITY|||||||0.387||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.387
74075559|NCT02728102|147704395|SUPERIORITY|||||||0.563||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between vaccine vs. non- vaccine arms.||||0.563
74075560|NCT02728102|147704396|SUPERIORITY|||||||0.308||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide/GM-CSF arm.||||0.308
74075561|NCT02728102|147704396|SUPERIORITY|||||||0.99||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide alone arm.||||0.990
74075562|NCT02728102|147704396|SUPERIORITY|||||||0.303||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.303
74075563|NCT02728102|147704398|SUPERIORITY|||||||0.189||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The null hypothesis is that there is no difference of proportions of patients With Grade ≥ 3 Toxicities between vaccine vs. non- vaccine arms.||||0.189
74075564|NCT02728102|147704400|SUPERIORITY|||||||0.82||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between vaccine vs. non- vaccine arms.||||0.82
74075565|NCT02728102|147704401|SUPERIORITY|||||||0.21||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the vaccine arm and lenalidomide/GM-CSF arm.||||0.21
74075566|NCT02728102|147704401|SUPERIORITY|||||||0.4||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the vaccine arm and lenalidomide alone arm.||||0.40
74075567|NCT02728102|147704401|SUPERIORITY|||||||0.08||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.08
74075568|NCT02728102|147704402|SUPERIORITY|||||||0.8||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||The null hypothesis is that there is no difference of proportions of patients without Minimal Residual Disease between vaccine vs. non- vaccine arms||||0.80
74075569|NCT00234286|147704435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.009|TWO_SIDED|95.0|1.09|1.76|||Generalized Estimating Equation|||||1.76|1.09|.009
74075570|NCT00234286|147704436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.96|||Generalized Estimating Equation|||||1.96|0.95|0.09
74075571|NCT00234286|147704437|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.69|TWO_SIDED|95.0|0.59|1.42|||Generalized Estimating Equation|||||1.42|0.59|0.69
74075572|NCT00234286|147704438|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.03|TWO_SIDED|95.0|0.53|0.96|||Generalized Estimating Equations|||||0.96|0.53|.03
74075573|NCT00234286|147704439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.15|TWO_SIDED|95.0|0.38|1.16|||Generalized Estimating Equation|||||1.16|0.38|0.15
74075574|NCT00234286|147704440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.86|TWO_SIDED|95.0|0.67|1.62|||Generalized Estimating Equation|||||1.62|0.67|0.86
74075575|NCT00234286|147704441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.96|||Generalized Estimating Equation|||||1.96|0.95|0.09
74075576|NCT00234286|147704442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.01|TWO_SIDED|95.0|1.17|3.36|||Generalized Estimating Equation|||||3.36|1.17|0.01
74075577|NCT00234286|147704443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.36|TWO_SIDED|95.0|0.73|2.35|||Generalized Estimating Equation|||||2.35|0.73|0.36
74075578|NCT00234286|147704444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.01|TWO_SIDED|95.0|1.08|1.77|||Generalized Estimating Equation|||||1.77|1.08|0.01
74075579|NCT00234286|147704445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.76|TWO_SIDED|95.0|0.7|1.3|||Generalized Estimating Equation|||||1.30|0.70|0.76
74075580|NCT00234286|147704446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.004|TWO_SIDED|95.0|1.41|5.44|||Generalized Estimating Equation|||||5.44|1.41|.004
74075581|NCT00234286|147704447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12||||0.007|TWO_SIDED|95.0|1.51|11.28|||Generalized Estimating Equations|||||11.28|1.51|0.007
74075582|NCT00234286|147704448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.14|TWO_SIDED|95.0|0.84|3.2|||Generalized Estimating Equations|||||3.20|0.84|0.14
74075583|NCT00234286|147704449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.003|TWO_SIDED|95.0|1.15|1.88|||Generalized Estimating Equation|||||1.88|1.15|.003
74075584|NCT00234286|147704450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.19|TWO_SIDED|95.0|0.62|9.7|||Generalized Estimation Equations|||||9.70|0.62|0.19
73884973|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.734||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.||||0.734
74075585|NCT02605395|147704451|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for Cmax to be within 80-125% to prove equivalency.|Ratio of means|95.71|||||TWO_SIDED|90.0|90.12|101.65||||||||101.65|90.12|
74075586|NCT02605395|147704452|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC(0-t) to be within 80-125% to prove equivalency.|Ratio of means|96.5|||||TWO_SIDED|90.0|90.02|103.44||||||||103.44|90.02|
74075587|NCT02605395|147704453|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC (0 to infinity) to be within 80-125% to prove equivalency.|Ratio of means|95.69|||||TWO_SIDED|90.0|87.06|105.17||||||||105.17|87.06|
74075588|NCT03555305|147704470|EQUIVALENCE|Analysis was performed using linear mixed effects model and participant as a random effect, with period, sequence, and treatment as fixed effects. The estimate of the ratio of means of each PK/PD parameters between the 2 treatments and the corresponding 90% confidence interval were calculated. A typical bio-equivalence limit (0.8 to 1.25) was used as equivalence margin.|Ratio of geometric least squares means|0.961|||||TWO_SIDED|90.0|0.886|1.04|||Linear mixed-effects model|||||1.04|0.886|
74075589|NCT03555305|147704471|EQUIVALENCE|Analysis was performed using linear mixed effects model and participant as a random effect, with period, sequence, and treatment as fixed effects. The estimate of the ratio of means of each PK/PD parameters between the 2 treatments and the corresponding 90% confidence interval were calculated. A typical bio-equivalence limit (0.8 to 1.25) was used as equivalence margin.|Ratio of geometric least squares means|0.943|||||TWO_SIDED|90.0|0.874|1.02|||Linear mixed-effects model|||||1.02|0.874|
74075590|NCT00323193|147704504|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANOVA|||||||.720
74075591|NCT00323193|147704505|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||.710
74075592|NCT00322465|147704521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||0.91|0.60|0.005
74075593|NCT00322465|147704521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.78|TWO_SIDED|95.0|0.33|2.3||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for scant discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||2.30|0.33|0.780
74075594|NCT00322465|147704521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.164|TWO_SIDED|95.0|0.75|5.33||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for moderate discharge amount (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||5.33|0.75|0.164
74075595|NCT00322465|147704521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.919|TWO_SIDED|95.0|0.23|5.17||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for large amount of discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multvariable logistic regression model.||5.17|0.23|0.919
74075596|NCT00322465|147704521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.051|TWO_SIDED|95.0|1.0|3.3||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1.||3.30|1.00|0.051
74075597|NCT00322465|147704521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.42||||0.076|TWO_SIDED|95.0|0.86|22.74||A priori threshold for statistical significance was p\<0.05|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 1 or more new sex partners in the last 30 days (reference category is 0) is 1 versus the alternative that it is greater than or less than 1.||22.74|0.86|0.076
74075598|NCT00322465|147704521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.075|TWO_SIDED|95.0|0.13|1.1||A priori threshold fors tatistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or sex for money, drugs, or other things (reference category is no) is 1 versus the alternative that it is greater than or less than 1.||1.10|0.13|0.075
74075599|NCT00322465|147704521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.001|TWO_SIDED|95.0|1.93|7.98||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for visit due to sexually transmitted disease contact (reference category is no) is 1 versus the alternative that it is greater than or less than 1.||7.98|1.93|<0.001
74075600|NCT00322465|147704522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2||||0.009|TWO_SIDED|95.0|0.06|0.66||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||0.66|0.06|0.009
74075601|NCT00322465|147704522|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39||||0.074|TWO_SIDED|95.0|0.92|6.22||A priori threshold for statistical signficance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or for money, drugs, or other things(reference category is no) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||6.22|0.92|0.074
74075602|NCT00322465|147704523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.032|TWO_SIDED|95.0|0.66|0.98||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|No other independent variables were included in the model.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that the odds ratio is greater than or less than 1.||0.98|0.66|0.032
74075603|NCT01073657|147704529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0|STANDARD_DEVIATION|33.9||0.0059|TWO_SIDED|95.0|14.0|38.0|||t-test, 2 sided|||||38|14|0.0059
74075604|NCT01790581|147704530|SUPERIORITY_OR_OTHER|||||||0.904|TWO_SIDED||||||MANOVA|||This analysis examined the change in balance scores from baseline to 1-day post intervention for all three reach distances (Anterior, Posteriomedial, Posteriolateral) using a MANOVA.||||.904
74075605|NCT01790581|147704532|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||MANOVA|||This analysis examined the change in disability scores from baseline to 1-day post intervention for both disability scores (FAAM, FAAM-S) using a MANOVA.||||.5
74075606|NCT00762307|147704538|OTHER||Mean Difference (Net)|18.7|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|14.9|22.4||||||||22.4|14.9|
74075607|NCT00762307|147704540|OTHER||sucess percentage|91.9|STANDARD_ERROR_OF_MEAN|5.2|||ONE_SIDED|||||||||||||
74075608|NCT06358820|147704545|SUPERIORITY|\>0.15 g/dL change in albumin from baseline to month 6 was anticipated.|Mean Difference (Final Values)|3.77|||<|0.0125|TWO_SIDED|95.0|3.15|4.39||A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.|ANOVA||The main analysis was based on LOCF for missing value.|Outcome Measure were assessed at baseline and every month during the 6-month study.||4.39|3.15|<0.0125
74075609|NCT06358820|147704546|SUPERIORITY|\>60 mg/L change in prealbumin from baseline to month 6.|Mean Difference (Net)|39.77||||0.0125|TWO_SIDED|95.0|26.66|56.87||A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.|ANOVA||The main analysis was based on LOCF for missing value.|||56.87|26.66|0.0125
74075610|NCT01124175|147704552|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|111.95|||||TWO_SIDED|90.0|101.84|123.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||123.06|101.84|
74075611|NCT01124175|147704553|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||TWO_SIDED|90.0|103.61|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.39|103.61|
74075612|NCT01124175|147704554|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.67|||||TWO_SIDED|90.0|103.32|108.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.07|103.32|
74075613|NCT01124175|147704555|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||TWO_SIDED|90.0|101.22|110.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||110.93|101.22|
74075614|NCT01124175|147704556|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|103.07|||||TWO_SIDED|90.0|100.9|105.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.28|100.90|
74075615|NCT01124175|147704557|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.36|||||TWO_SIDED|90.0|100.41|104.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.34|100.41|
74075616|NCT00486863|147704558|SUPERIORITY_OR_OTHER|||||||0.988||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.988
74075617|NCT00486863|147704559|SUPERIORITY_OR_OTHER||||||>|0.999||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||>0.999
74075618|NCT00486863|147704560|SUPERIORITY_OR_OTHER|||||||0.926||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.926
74075619|NCT00486863|147704561|SUPERIORITY_OR_OTHER|||||||0.502||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||0.502
74075620|NCT00486863|147704562|SUPERIORITY_OR_OTHER|||||||0.439||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||0.439
74075621|NCT00486863|147704563|SUPERIORITY_OR_OTHER|||||||0.704||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.704
74075622|NCT00486863|147704564|SUPERIORITY_OR_OTHER|||||||0.517||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.517
74075623|NCT00486863|147704565|SUPERIORITY_OR_OTHER|||||||0.524||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the cord blood.||||0.524
74075624|NCT00486863|147704565|SUPERIORITY_OR_OTHER|||||||0.07||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the heel stick.||||0.070
74075625|NCT00486863|147704566|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||<0.001
74075626|NCT00486863|147704571|SUPERIORITY_OR_OTHER|||||||0.991||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||0.991
73888523|NCT05465317|147309655|OTHER||Hazard Ratio (HR)|0.93||||0.76|TWO_SIDED|95.0|0.6|1.45|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.45|0.60|0.76
74075627|NCT00355797|147704596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.17|STANDARD_DEVIATION|15.9||0.004|TWO_SIDED|95.0|3.24|15.11|||t-test, 2 sided|||The endpoint will compare the composite percent change in ADL performance for patients while their devices are programmed to CLS and accelerometer pacing modes, using the no rate adaptive pacing mode as the baseline. Null hypothesis: mean composite of percent change for patients with their device programmed to CLS is less than or equal to the mean composite of percent change for the same patients with their device in accelerometer.||15.11|3.24|0.004
74075628|NCT00355797|147704603|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.42|STANDARD_DEVIATION|17.74||0.552|TWO_SIDED|95.0|-6.17|3.33|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device in accelerometer.||3.33|-6.17|0.552
74075629|NCT00355797|147704603|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.91|STANDARD_DEVIATION|21.34||0.505|TWO_SIDED|95.0|-3.8|7.63|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device without rate adaptative pacing.||7.63|-3.80|0.505
74075630|NCT00834535|147704623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.83||||||90.0|93.98|108.17|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.17|93.98|
74075631|NCT00834535|147704624|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.1||||||90.0|92.14|100.22|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.22|92.14|
74075632|NCT00834535|147704625|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.57||||||90.0|92.8|100.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.49|92.8|
74075633|NCT02055963|147704648|OTHER|||||||0.98|||||||Wilcoxon Rank Sum Test|||||||0.98
74075634|NCT02028715|147704650|SUPERIORITY||Mean Difference (Final Values)|5.55501|STANDARD_ERROR_OF_MEAN|5.96535||0.356|TWO_SIDED|95.0|-6.3904|17.50042|||t-test for Equality of Means|||||17.50042|-6.39040|.356
74075635|NCT02028715|147704651|SUPERIORITY||Median Difference (Final Values)|11.51818|STANDARD_ERROR_OF_MEAN|6.98569||0.105|TWO_SIDED|95.0|-2.49963|25.53599|||t-test for Equality of Means|||||25.53599|-2.49963|.105
74075636|NCT02028715|147704652|SUPERIORITY|||||||0.029|||||||ANOVA|||||||.029
74075637|NCT02028715|147704653|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.643|||||||ANOVA|||||||.643
74075638|NCT02028715|147704654|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.217|||||||ANOVA|||||||.217
74075639|NCT02028715|147704655|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.647|||||||ANOVA|||||||.647
74075640|NCT02028715|147704656|SUPERIORITY||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.587|0.695||||||||.695|-.587|
74075641|NCT01819597|147704695|OTHER|This is a phase II study design to determine the non-futility of proceeding to a phase III pivotal evaluation. The study group was planned to be compared to a propensity score matching (PSM) cohort from to the patients in the medical arms of the SAMMPRIS trial and to patients in the medical arm of COSS that had demonstrated angiographic intracranial atherosclerosis and occlusion.|Hazard Ratio (HR)|0.38||||0.08|TWO_SIDED|90.0|0.14|0.94||Pre-established α ≤ 0.10 for phase IIa|Regression, Cox|Alpha set at ≤ 0.1. for phase II study|ERSIAS/ Controls.|We derived the sample size required to power the trial to test the difference between two binomial event rates using the method of Farrington and Manning as implemented in R package gsDesign (Anderson, 2011). An estimated sample size of 52 patients will be necessary to detect a ∆ of 0.05, with a one-sided alpha of 0.10 and a beta of 0.10 - acceptable parameters for a non-definitive, non-futility study (Palesch et al., 2005, Levin, 2005).||0.94|0.14|0.08
74075642|NCT02495857|147704702|SUPERIORITY||Mean Difference (Net)|36.18|||||TWO_SIDED|95.0|10.25|62.11||||||||62.11|10.25|
74075643|NCT02495857|147704703|SUPERIORITY||Mean Difference (Net)|36.19|||||TWO_SIDED|95.0|10.25|62.11||||||||62.11|10.25|
74075644|NCT02495857|147704704|EQUIVALENCE|From baseline to week 26 visit, change in the WOMAC stiffness score was evaluated.|Mean Difference (Net)|5.63|||||TWO_SIDED|95.0|-13.61|8.49||||||||8.49|-13.61|
74075645|NCT02883452|147704712|NON_INFERIORITY|The non-inferiority of CT-P13 SC to CT-P13 IV was to be concluded if the lower bound of two-sided 90% CI for the ratio of geometric least square means was higher than 80%.|Ratio of Geometric LS means|1154.17|||||TWO_SIDED|90.0|786.37|1694.0|||||The geometric lease square (LS) means, ratio of geometric LS means (CT-P13 SC 120/240 mg to CT-P13 IV 5 mg/kg), and 2-sided 90% CI were obtained from the ANCOVA model.|Primary PK analysis was analyzed using an ANCOVA with treatment as fixed effect and current use of treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX) (used or not used), disease (CD or UC), clinical response at Week 6 (responder or non-responder by Clinical Disease Activity Index \[CDAI\]-70 for CD or partial Mayo score for UC), body weight at Week 6 (\<80 kg or ≥80 kg) fitted as covariates.||1694.00|786.37|
74075646|NCT00830206|147704719|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® Software.|Geometric Test/Ref Ratio x 100|102.62||||||90.0|94.84|111.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.05|94.84|
73884974|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.693||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS.||||0.693
73884975|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.720
73884976|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.722
73884977|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.480
73884978|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.498
73884979|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.865||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.865
73884980|NCT00385671|147303869|SUPERIORITY_OR_OTHER|||||||0.408||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.408
73884981|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.635|TWO_SIDED|95.0|-2.18|1.33||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.||1.33|-2.18|0.635
73884982|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.092|TWO_SIDED|95.0|-3.24|0.24||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS total score.||0.24|-3.24|0.092
73884983|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.221|TWO_SIDED|95.0|-2.8|0.65||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.||0.65|-2.80|0.221
73888524|NCT05465317|147309656|OTHER||Hazard Ratio (HR)|0.68||||0.39|TWO_SIDED|95.0|0.29|1.62|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.62|0.29|0.39
74075647|NCT00830206|147704720|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|100.85||||||90.0|94.48|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.65|94.48|
74075648|NCT00830206|147704721|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokimetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|101.92||||||90.0|95.18|109.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.14|95.18|
73884984|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.974|TWO_SIDED|95.0|-0.88|0.85||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.85|-0.88|0.974
73884985|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.093|TWO_SIDED|95.0|-1.63|0.13||P-value is for Item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.13|-1.63|0.093
74075649|NCT04605094|147704723|OTHER||Difference in response rate|-8.62||||0.08|TWO_SIDED|95.0|-17.94|0.71|||Regression, Logistic|||"Treatment difference in IGA responders~Estimates were from a logistic regression model that included treatment group, age as recorded on electronic case report form (eCRF) at screening (\>=12 to \<18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/microliters \[μL\]; \>=300 cells/μL) and baseline value of IGA score."||0.71|-17.94|0.080
74075650|NCT04605094|147704724|OTHER||Difference in response rate|-5.15||||0.384|TWO_SIDED|95.0|-16.67|6.36|||Regression, Logistic|||"Treatment difference in EASI-75 responders~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline EASI total score."||6.36|-16.67|0.384
74075651|NCT04605094|147704725|OTHER||Difference in response rate|-8.18||||0.078|TWO_SIDED|95.0|-16.94|0.59|||Regression, Logistic|||"Treatment difference in EASI-90 responders~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline EASI total score."||0.59|-16.94|0.078
74075652|NCT04605094|147704726|OTHER||Difference in response rate|0.69||||0.889|TWO_SIDED|95.0|-8.93|10.32|||Regression, Logistic|||"Treatment difference in Peak Pruritus NRS~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline Peak Pruritus score."||10.32|-8.93|0.889
74075653|NCT02724462|147704729|SUPERIORITY||Odds Ratio (OR)|1.49|||<|0.001|TWO_SIDED|95.0|1.22|1.83|||Regression, Logistic|||||1.83|1.22|<.001
74075654|NCT02724462|147704730|SUPERIORITY||Odds Ratio (OR)|1.4||||0.001|TWO_SIDED|95.0|1.14|1.71|||Regression, Logistic|||||1.71|1.14|.001
74075655|NCT02393417|147704775|SUPERIORITY||Risk Ratio (RR)|1.5706||||0.0329|TWO_SIDED|95.0|1.0184|2.4223|||Cochran-Mantel-Haenszel|||||2.4223|1.0184|0.0329
74075656|NCT02393417|147704775|SUPERIORITY||Risk Ratio (RR)|1.8926||||0.0007|TWO_SIDED|95.0|1.2722|2.8156|||Cochran-Mantel-Haenszel|||||2.8156|1.2722|0.0007
74075657|NCT02393417|147704775|SUPERIORITY||Risk Ratio (RR)|1.7319||||0.0052|TWO_SIDED|95.0|1.1602|2.5854|||Cochran-Mantel-Haenszel|||||2.5854|1.1602|0.0052
74075658|NCT02393417|147704776|SUPERIORITY||Risk Ratio (RR)|1.3828||||0.4307|TWO_SIDED|95.0|0.6191|3.0883|||Cochran-Mantel-Haenszel|||||3.0883|0.6191|0.4307
74075659|NCT02393417|147704776|SUPERIORITY||Risk Ratio (RR)|2.8908||||0.0014|TWO_SIDED|95.0|1.4169|5.8978|||Cochran-Mantel-Haenszel|||||5.8978|1.4169|0.0014
74075660|NCT02393417|147704776|SUPERIORITY||Risk Ratio (RR)|3.0||||0.0451|TWO_SIDED|95.0|0.9281|9.6975|||Cochran-Mantel-Haenszel|||||9.6975|0.9281|0.0451
74075661|NCT02393417|147704778|SUPERIORITY||Cox Proportional Hazard|2.7553||||0.0027|TWO_SIDED|95.0|1.4211|5.3419|||Regression, Cox|||||5.3419|1.4211|0.0027
74075662|NCT02393417|147704778|SUPERIORITY||Cox Proportional Hazard|3.1516||||0.0008|TWO_SIDED|95.0|1.6148|6.1509|||Regression, Cox|||||6.1509|1.6148|0.0008
74075663|NCT02393417|147704778|SUPERIORITY||Cox Proportional Hazard|3.3257||||0.0003|TWO_SIDED|95.0|1.7263|6.407|||Regression, Cox|||||6.4070|1.7263|0.0003
74075664|NCT02393417|147704784|SUPERIORITY||Odds Ratio (OR)|0.999||||0.4824|TWO_SIDED|95.0|0.997|1.001|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.001|0.997|0.4824
74075665|NCT02393417|147704784|SUPERIORITY||Odds Ratio (OR)|1.001||||0.5007|TWO_SIDED|95.0|0.998|1.004|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.004|0.998|0.5007
74075666|NCT02393417|147704784|SUPERIORITY||Odds Ratio (OR)|0.993||||0.0219|TWO_SIDED|95.0|0.987|0.999|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||0.999|0.987|0.0219
73884986|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.091|TWO_SIDED|95.0|-1.59|0.12||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.12|-1.59|0.091
74075667|NCT02393417|147704784|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8267|TWO_SIDED|95.0|0.995|1.004|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.004|0.995|0.8267
74075668|NCT02393417|147704785|SUPERIORITY||Odds Ratio (OR)|0.964||||0.1657|TWO_SIDED|95.0|0.915|1.015|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.015|0.915|0.1657
74075669|NCT02393417|147704785|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8168|TWO_SIDED|95.0|0.997|1.003|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.003|0.997|0.8168
74075670|NCT02393417|147704785|SUPERIORITY||Odds Ratio (OR)|0.998||||0.4183|TWO_SIDED|95.0|0.993|1.003|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.003|0.993|0.4183
74075671|NCT02393417|147704785|SUPERIORITY||Odds Ratio (OR)|1.001||||0.5572|TWO_SIDED|95.0|0.997|1.006|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.006|0.997|0.5572
74075672|NCT00829673|147704826|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.82||||||90.0|100.24|115.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115.98|100.24|
74075673|NCT00829673|147704827|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.74||||||90.0|97.3|104.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.29|97.3|
74075674|NCT00829673|147704828|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.5||||||90.0|97.09|104.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.03|97.09|
74075675|NCT03450057|147704829|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
74075676|NCT03450057|147704830|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
74075677|NCT03450057|147704831|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
74075678|NCT03450057|147704832|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
74075679|NCT03450057|147704833|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
74075680|NCT03450057|147704834|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
74075681|NCT00829790|147704846|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|114.49||||||90.0|109.25|119.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||119.98|109.25|
73884987|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.733|TWO_SIDED|95.0|-0.75|0.52||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 2 score.||0.52|-0.75|0.733
73884988|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.102|TWO_SIDED|95.0|-1.15|0.11||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.||0.11|-1.15|0.102
73884989|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.193|TWO_SIDED|95.0|-1.04|0.21||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.||0.21|-1.04|0.193
73884990|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.584|TWO_SIDED|95.0|-0.76|0.43||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.43|-0.76|0.584
73884991|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.077|TWO_SIDED|95.0|-1.12|0.06||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.06|-1.12|0.077
73884992|NCT00385671|147303870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.221|TWO_SIDED|95.0|-0.95|0.22||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.22|-0.95|0.221
74075682|NCT00829790|147704847|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|117.16||||||90.0|110.44|124.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||124.28|110.44|
74075683|NCT00829790|147704848|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|116.7||||||90.0|109.89|123.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123.92|109.89|
74075684|NCT02246166|147704849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9473|TWO_SIDED|95.0|-0.77|0.83|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||0.83|-0.77|0.9473
74075685|NCT02246166|147704850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.721|TWO_SIDED|95.0|-1.23|0.86|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatme|||0.86|-1.23|0.7210
74075686|NCT02246166|147704851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.7445|TWO_SIDED|95.0|-1.07|1.49|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.||||1.49|-1.07|0.7445
74075687|NCT02246166|147704852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.7662|TWO_SIDED|95.0|-1.32|1.78|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate||||1.78|-1.32|0.7662
74075688|NCT02246166|147704853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.5208|TWO_SIDED|95.0|-1.18|2.29|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||2.29|-1.18|0.5208
74075689|NCT02246166|147704854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.8993|TWO_SIDED|95.0|-1.71|1.94|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||1.94|-1.71|0.8993
74075690|NCT00627016|147704864|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance for the comparison of the primary endpoint was determined at 0.05 level.|Wilcoxon (Mann-Whitney)|||||||<0.001
74075691|NCT00627016|147704865|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact|||||||<0.001
74075692|NCT00627016|147704866|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact|||||||<0.001
74075693|NCT00377260|147704882|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical treatment failures by the on-therapy visit.||||< .001
74075694|NCT00377260|147704883|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical failures by the end of therapy.||||< .001
74075695|NCT00377260|147704884|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.||||.02
74075696|NCT00377260|147704885|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children who develop worsening symptoms within the first 3 days of treatment.||||.24
74075697|NCT00377260|147704886|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||A weighted regression model was used with weights equal to the number of days information regarding analgesic use was reported by the parents.|Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the average number of doses of analgesic medication administered by parents.||||.35
74075698|NCT00377260|147704887|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with protocol-defined diarrhea.||||.04
74075699|NCT00377260|147704887|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with diaper dermatitis.||||<.01
74075700|NCT00377260|147704887|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with oral thrush.||||.07
74075701|NCT00377260|147704887|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with vomiting.||||>.99
74075702|NCT00377260|147704887|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with rash.||||>.99
74075703|NCT00377260|147704887|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with mastoiditis.||||.99
74075704|NCT00377260|147704887|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with perforation of their tympanic membrane.||||.08
74075705|NCT00377260|147704888|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.||||.002
74075706|NCT00377260|147704888|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.||||<.001
74075707|NCT00377260|147704888|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.||||.85
74075708|NCT00377260|147704888|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.||||<.001
74075709|NCT00377260|147704888|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.||||.28
74075710|NCT00377260|147704889|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.||||< .001
74075711|NCT00377260|147704890|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.||||.10
74075712|NCT00377260|147704890|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.||||.03
74075713|NCT00377260|147704890|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.||||.96
74075714|NCT00377260|147704890|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.||||.79
74075715|NCT00377260|147704890|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.||||.98
74075716|NCT00377260|147704891|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.||||.04
74075717|NCT00377260|147704892|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the on-therapy visit.||||.03
74075718|NCT00377260|147704893|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the end-of-therapy visit.||||.006
74075719|NCT00377260|147704894|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.||||.04
74075720|NCT00377260|147704895|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to primary care provider.||||.20
74075721|NCT00377260|147704896|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to emergency room||||.90
74075722|NCT00377260|147704897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.14||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \<=1.||||.14
74075723|NCT00377260|147704898|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.04||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \<=1 on two consecutive occasions.||||.04
74075724|NCT00377260|147704899|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Generalized estimating equations|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the number of antibiotic prescriptions, exclusive of the blinded study medication.||||<.001
74075725|NCT00377260|147704900|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported missing work, i.e. number of such visits / total number of follow-up assessment visits.||||.93
74075726|NCT00377260|147704901|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported making special daycare arrangements, i.e. number of such visits / total number of follow-up assessment visits.||||.66
74075727|NCT00377260|147704902|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the on-therapy visit.||||.71
74075728|NCT00377260|147704903|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the end-of-therapy visit.||||.04
74075729|NCT00377260|147704904|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the follow-visit visit.||||.005
74075730|NCT00377260|147704905|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the mean weighted average acute otitis media - severity of symptom (AOM-SOS) score (symptom burden), post-enrollment, over the first 7 days of therapy.||||.01
74075731|NCT04567186|147704923|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.00 logMAR.|Least-square mean|-0.078|STANDARD_ERROR_OF_MEAN|0.0105|||TWO_SIDED|95.0|-0.099|-0.057|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Distance (4 meter)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||-0.057|-0.099|
74075732|NCT04567186|147704923|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold + 0.17 logMAR.|Least-square mean|-0.059|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.079|-0.039|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Intermediate (64cm)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||-0.039|-0.079|
74075733|NCT04567186|147704923|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.17 logMAR.|Least-square Mean|0.062|STANDARD_ERROR_OF_MEAN|0.0111|||TWO_SIDED|95.0|0.04|0.084|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom|Near (40cm)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||0.084|0.040|
74075734|NCT04567186|147704924|SUPERIORITY|The superiority of the Test lens was concluded if the lower confidence limit of the least-square mean was above the threshold of 32 points.|Least-square Mean|55.93|STANDARD_ERROR_OF_MEAN|2.9027|||TWO_SIDED|95.0|49.25|62.61|||Linear Mixed Model|The Kenward and Roger method was used for the denominator degrees of freedom||This study was powered to only test primary hypotheses.||62.61|49.25|
74075735|NCT04567186|147704924|NON_INFERIORITY|A Non-Inferiority margin of 5 points was used.|Least-square mean difference|-2.98|STANDARD_ERROR_OF_MEAN|1.4708|||TWO_SIDED|95.0|-5.893|-0.073|||Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom|mean difference was calculated as Test minus Control|This study was powered for only the primary hypotheses.||-0.073|-5.893|
74075736|NCT02924883|147704925|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3332||95.0|0.55|1.23|||Log Rank|The 2-sided log-rank test, was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).||||1.23|0.55|0.3332
74075737|NCT02924883|147704927|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2934||95.0|0.42|1.3|||Log Rank|The 2-sided log-rank test was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).||||1.30|0.42|0.2934
74075738|NCT02924883|147704929|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.6099||95.0|0.52|3.03|||Log Rank|Stratified Cox proportional hazards model was stratified by world region (Western Europe, U.S., Rest of World) and PD-L1 status (IC 0, IC 1/2/3).||||3.03|0.52|0.6099
74075739|NCT02678286|147704970|SUPERIORITY|||||||0.0145|||||||t-test, 2 sided|||||||0.0145
74075740|NCT02678286|147704971|SUPERIORITY|||||||0.1841||||||Row 1 (SPID6)|t-test, 2 sided|||||||0.1841
74075741|NCT02678286|147704971|SUPERIORITY|||||||0.0434||||||Row 2 (SPID12)|t-test, 2 sided|||||||0.0434
74075742|NCT02678286|147704971|SUPERIORITY|||||||0.004||||||Row 3 (SPID48)|t-test, 2 sided|||||||0.0040
74075743|NCT02678286|147704971|SUPERIORITY|||||||0.0028||||||Row 4 (SPID24-48)|t-test, 2 sided|||||||0.0028
74075744|NCT02678286|147704972|SUPERIORITY|||||||0.7572|||||||Log Rank|||||||0.7572
74075745|NCT02678286|147704973|SUPERIORITY|||||||0.6559||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel|||||||0.6559
74075746|NCT02678286|147704973|SUPERIORITY|||||||0.0014||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel|||||||0.0014
74075747|NCT02678286|147704973|SUPERIORITY|||||||0.4994||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel|||||||0.4994
74075748|NCT02678286|147704974|SUPERIORITY|||||||0.0275||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0275
74075749|NCT02678286|147704974|SUPERIORITY|||||||0.0009||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0009
74075750|NCT02678286|147704974|SUPERIORITY|||||||0.0027||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0027
74075751|NCT02678286|147704975|SUPERIORITY|||||||0.005|||||||Log Rank|||||||0.0050
74075752|NCT02678286|147704976|SUPERIORITY|||||||0.5096|||||||Log Rank|||||||0.5096
74075753|NCT02678286|147704977|SUPERIORITY|||||||0.389|||||||Cochran-Mantel-Haenszel|||||||0.3890
74075754|NCT02678286|147704978|SUPERIORITY|||||||0.0178|||||||Cochran-Mantel-Haenszel|||||||0.0178
74075755|NCT02678286|147704979|SUPERIORITY|||||||0.1888|||||||Cochran-Mantel-Haenszel|||||||0.1888
74075756|NCT02678286|147704980|SUPERIORITY|||||||0.0788|||||||Cochran-Mantel-Haenszel|||||||0.0788
74075757|NCT02678286|147704981|SUPERIORITY|||||||0.0607|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0607
74075758|NCT02678286|147704982|SUPERIORITY|||||||0.0027|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0027
74075759|NCT04459585|147704989|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.88|||||TWO_SIDED|90.0|77.57|161.35|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||161.35|77.57|
73884993|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.096|TWO_SIDED|95.0|-3.96|0.32||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||0.32|-3.96|0.096
73884994|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.353|TWO_SIDED|95.0|-3.16|1.13||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.13|-3.16|0.353
74075760|NCT04459585|147704989|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|112.98|||||TWO_SIDED|90.0|77.2|165.34|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||165.34|77.20|
74075761|NCT04459585|147704990|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.37|||||TWO_SIDED|90.0|78.51|157.97|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||157.97|78.51|
74075762|NCT04459585|147704990|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.08|||||TWO_SIDED|90.0|77.35|159.51|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||159.51|77.35|
74075763|NCT04459585|147704991|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|112.97|||||TWO_SIDED|90.0|79.38|160.79|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||160.79|79.38|
74075764|NCT04459585|147704991|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|110.72|||||TWO_SIDED|90.0|76.77|159.68|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||159.68|76.77|
74075765|NCT01061866|147705006|NON_INFERIORITY_OR_EQUIVALENCE|p less than or equal to 0.05, repeated measures ANOVA|Mean Difference (Final Values)|0.02|||<|0.02||||||p-value is non-adjusted for multiple comparisons|ANOVA|Was adjusted the degrees of freedom for the averaged test of significance.|The frequency of seizures at the beginning of the study and after treatment with thalidomide was contrasted in the same group patients.|Power=0.02||||<0.02
74075766|NCT00772941|147705007|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of Treatment Related Adverse Events."||||<0.001
74075767|NCT00772941|147705008|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years and \>=65 years in the frequency of Treatment Related Adverse Events."||||<0.001
74075768|NCT00772941|147705009|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Chronic obstructive pulmonary disease as a complication. The null hypothesis is that there is no difference between Varenicline with and without Chronic obstructive pulmonary disease as a complication in the frequency of Treatment Related Adverse Events."||||<0.001
74075769|NCT00772941|147705010|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was concomitant drugs. The null hypothesis is that there is no difference between Varenicline with and without concomitant drugs in the frequency of Treatment Related Adverse Events."||||<0.001
74075770|NCT00772941|147705011|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was concomitant therapies. The null hypothesis is that there is no difference between Varenicline with and without concomitant therapies in the frequency of Treatment Related Adverse Events."||||<0.001
74075771|NCT00772941|147705012|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no association between Weight at Baseline and the frequency of Treatment Related Adverse Events."||||<0.001
74075772|NCT00772941|147705012|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Armitage|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no linear trend in the frequency of Treatment Related Adverse Events across increasing levels of Weight at Baseline."||||<0.001
74075773|NCT00772941|147705013|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no association between Tobacco consumption per day and the efficacy of Varenicline."||||<0.001
73884995|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.444|TWO_SIDED|95.0|-1.27|2.88||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||2.88|-1.27|0.444
73884996|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.682|TWO_SIDED|95.0|-2.29|3.48||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||3.48|-2.29|0.682
73888525|NCT05465317|147309656|OTHER||Hazard Ratio (HR)|0.46||||0.34|TWO_SIDED|95.0|0.09|2.27|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.27|0.09|0.34
74075774|NCT00772941|147705013|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Armitage|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no linear trend in the efficacy of Varenicline across increasing levels of tobacco consumption per day."||||<0.001
74075775|NCT00772941|147705014|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was prolonged administration after 12 weeks. The null hypothesis is that there is no difference between administration prolonged after 12 weeks and administration not prolonged after 12 weeks in the efficacy of Varenicline."||||<0.001
74075776|NCT00772941|147705015|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was antipsychotics as a concomitant drug. The null hypothesis is that there is no difference between Varenicline with and without antipsychotics as a concomitant drug in the efficacy of Varenicline."||||<0.001
74075777|NCT00834756|147705037|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.0||||||90.0|87.96|104.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.78|87.96|
74075778|NCT00834756|147705038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.63||||||90.0|92.34|105.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.35|92.34|
74075779|NCT00834756|147705039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.37||||||90.0|93.95|107.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.21|93.95|
74075780|NCT02251886|147705045|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.48|TWO_SIDED|95.0|0.77|1.76|||Chi-squared|||||1.76|0.77|0.48
74075781|NCT02251886|147705045|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.69|1.46|||Chi-squared|||||1.46|0.69|1.00
74075782|NCT02819323|147705046|NON_INFERIORITY|Non-inferiority margin = 10%||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
74075783|NCT02819323|147705046|NON_INFERIORITY|Non-inferiority margin = 10%||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
74075784|NCT02819323|147705046|SUPERIORITY|||||||0.046|||||||Cochran-Mantel-Haenszel|||||||0.046
74075785|NCT02819323|147705046|SUPERIORITY|||||||0.089|||||||Cochran-Mantel-Haenszel|||||||0.089
74075786|NCT02331394|147705093|EQUIVALENCE|"The equivalence assumes that the true mean difference between the paired samples is zero. Under this model, all observable differences are explained by random variation.Equality margins are:~Upper Equivalence Margin=1.5 Lower Equivalence Margin=-1.5"|||||<|0.05|||||||t-test, 2 sided|||Comparisons of repeated measures were made using paired sample t test, which compared subjects data at 2 different times: baseline and end of the study. A P value of 0.05 was considered statistically significant||||<0.05
74075787|NCT02331394|147705096|SUPERIORITY|Pared t-test was used to evaluate the significance of the change in scores||||||0.02|||||||t-test, 2 sided|||||||0.02
74075788|NCT02459951|147705110|SUPERIORITY|||||||0.059||||||"refer to cylinder A (.5 diameter)"|Regression, Logistic|||||||.059
74075789|NCT02459951|147705110|SUPERIORITY||geometric mean ratio B|||||0.465|||||||Regression, Logistic|"refer to cylinder B(1 diameter)"||||||0.465
74075790|NCT02459951|147705110|SUPERIORITY||geometric mean ratio C|||||0.022||||||"refer to cylinder C (1.5 diameter)"|Regression, Logistic|||||||.022
74075791|NCT02459951|147705110|SUPERIORITY||geometric mean ratio D|||||0.004||||||"refer to cylinder D (2 diameter)"|Regression, Logistic|||||||.004
74075792|NCT02459951|147705110|SUPERIORITY||geometric mean ratio E|||||0.002||||||"refer to cylinder E (2.5 diameter)"|Regression, Logistic|||||||.002
74075793|NCT02481830|147705117|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1144|TWO_SIDED|95.0|0.72|1.04|||Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin|||1.04|0.72|0.1144
73888526|NCT05465317|147309656|OTHER||Hazard Ratio (HR)|0.82||||0.72|TWO_SIDED|95.0|0.29|2.33|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.33|0.29|0.72
74075794|NCT02481830|147705118|SUPERIORITY||Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|1.16|1.66|||||Hazard Ratio is Nivolumab over Topotecan/Amrubicin using Stratified Cox proportional hazard model|||1.66|1.16|
74075795|NCT02481830|147705119|SUPERIORITY||Estimate of Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.49|1.24|||||Strata adjusted odds ratio (Nivolumab over Topotecan/Amrubicin) using Mantel-Haenszel method|||1.24|0.49|
74075796|NCT02481830|147705120|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.73|1.04|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin|||1.04|0.73|
74075797|NCT00102440|147705121|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|32.0||||||97.5|23.1|41.3||||||||41.3|23.1|
74075798|NCT00102440|147705121|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|41.0||||||97.5|31.5|49.5||||||||49.5|31.5|
74075799|NCT00102440|147705121|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact|||||||<0.001
74075800|NCT00102440|147705121|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact|||||||<0.001
74075801|NCT00102440|147705121|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.072
74075802|NCT00102440|147705122|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
74075803|NCT00102440|147705122|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
74075804|NCT00102440|147705122|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.031
74075805|NCT00102440|147705123|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
74075806|NCT00102440|147705123|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
74075807|NCT00102440|147705123|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.883
74075808|NCT00102440|147705124|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
74075809|NCT00102440|147705124|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
74075810|NCT00102440|147705124|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.164
74075811|NCT00102440|147705125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
74075812|NCT00102440|147705125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
73888527|NCT05465317|147309657|OTHER||Hazard Ratio (HR)|0.84||||0.62|TWO_SIDED|95.0|0.43|1.66|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.66|0.43|0.62
74075813|NCT00102440|147705125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
74075814|NCT00102440|147705126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
74075815|NCT00102440|147705126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
74075816|NCT00102440|147705126|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||0.006
74075817|NCT00102440|147705127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
74075818|NCT00102440|147705127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
74075819|NCT00102440|147705127|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
74075820|NCT00102440|147705128|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||>0.999
74075821|NCT00102440|147705128|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.011
74075822|NCT00102440|147705128|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.024
74075823|NCT00102440|147705129|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.083
74075824|NCT00102440|147705129|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.164
74075825|NCT00102440|147705129|SUPERIORITY_OR_OTHER|||||||0.619||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.619
74075826|NCT00102440|147705130|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.080
74075827|NCT00102440|147705130|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.372
74075828|NCT00102440|147705130|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.246
74075829|NCT00102440|147705131|SUPERIORITY_OR_OTHER|||||||0.674||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.674
74075830|NCT00102440|147705131|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.320
74075831|NCT00102440|147705131|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.411
74075832|NCT00102440|147705132|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.507
74075833|NCT00102440|147705132|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.188
74075834|NCT00102440|147705132|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.362
74075835|NCT00102440|147705133|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.657
74075836|NCT00102440|147705133|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.444
74075837|NCT00102440|147705133|SUPERIORITY_OR_OTHER|||||||0.719||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.719
74075838|NCT00102440|147705134|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||>0.999
74075839|NCT00102440|147705134|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.229
74075840|NCT00102440|147705134|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.266
74075841|NCT04627038|147705135|SUPERIORITY||Posterior Mean Difference|0.09|||||TWO_SIDED|95.0|-0.51|0.67|||||Posterior mean difference with 95% credible interval is reported.|||0.67|-0.51|
74075842|NCT04627038|147705136|SUPERIORITY||Posterior Mean Difference|0.95|||||TWO_SIDED|95.0|-0.07|1.96|||||Posterior mean difference with 95% credible interval is reported.|||1.96|-0.07|
74075843|NCT04627038|147705137|SUPERIORITY||Posterior Mean Difference|0.24|||||TWO_SIDED|95.0|-0.24|0.72|||||Posterior mean difference with 95% credible interval is reported.|||0.72|-0.24|
74075844|NCT04627038|147705138|SUPERIORITY||Posterior Mean Difference|3.84|||||TWO_SIDED|95.0|0.39|7.2|||||Posterior mean difference with 95% credible interval is reported.|||7.20|0.39|
74075845|NCT04627038|147705139|SUPERIORITY||Posterior Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.48|0.28|||||Posterior mean difference with 95% credible interval is reported.|||0.28|-0.48|
74075846|NCT04627038|147705140|SUPERIORITY||Posterior Mean Difference|0.31|||||TWO_SIDED|95.0|-0.32|0.95|||||Posterior mean difference with 95% credible interval is reported.|||0.95|-0.32|
74075847|NCT04627038|147705141|SUPERIORITY||Posterior Mean Difference|6.24|||||TWO_SIDED|95.0|-1.05|13.56|||||Posterior mean difference with 95% credible interval is reported.|||13.56|-1.05|
74075848|NCT04627038|147705142|SUPERIORITY||Posterior Mean Difference|0.16|||||TWO_SIDED|95.0|-0.14|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.14|
74075849|NCT04627038|147705143|SUPERIORITY||Posterior Mean Difference|-0.82|||||TWO_SIDED|95.0|-166.74|165.52|||||Posterior mean difference with 95% credible interval is reported.|||165.52|-166.74|
74075850|NCT04627038|147705144|SUPERIORITY||Posterior Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.09|0.06|||||Posterior mean difference with 95% credible interval is reported.|||0.06|-0.09|
74075851|NCT02255097|147705145|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
74075852|NCT02255097|147705146|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
74075853|NCT02255097|147705149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
74075854|NCT02255097|147705150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0027|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||0.0027
74075855|NCT02255097|147705151|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
74075856|NCT02255097|147705152|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
74075857|NCT02255097|147705153|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
74075858|NCT03956862|147705210|SUPERIORITY||Mean Difference (Net)|-0.2||||0.9499|TWO_SIDED|95.0|-7.6|7.1|||Mixed Models Analysis||GB001 vs. Placebo|||7.1|-7.6|0.9499
74075859|NCT03956862|147705211|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6778|TWO_SIDED|95.0|-1.8|1.2|||ANCOVA||GB001 vs. Placebo|||1.2|-1.8|0.6778
74075860|NCT03956862|147705212|SUPERIORITY||Mean Difference (Net)|0.1||||0.7914|TWO_SIDED|95.0|-0.7|0.9|||Mixed Models Analysis||GB001 vs. Placebo|||0.9|-0.7|0.7914
74075861|NCT03956862|147705213|SUPERIORITY||Hazard Ratio (HR)|0.944||||0.8916|TWO_SIDED|95.0|0.41|2.173|||Regression, Cox||GB001 vs Placebo|||2.173|0.410|0.8916
74075862|NCT03956862|147705214|SUPERIORITY||Mean Difference (Net)|0.191||||0.1635|TWO_SIDED|95.0|-0.077|0.459|||Mixed Models Analysis||GB001 vs. Placebo|||0.459|-0.077|0.1635
74075863|NCT03956862|147705215|SUPERIORITY||Mean Difference (Net)|0.632||||0.1742|TWO_SIDED|95.0|-0.28|1.544|||Mixed Models Analysis||GB001 vs. Placebo|||1.544|-0.280|0.1742
74075864|NCT03956862|147705216|SUPERIORITY||Mean Difference (Net)|0.9||||0.4851|TWO_SIDED|95.0|-1.6|3.4|||ANCOVA||GB001 vs. Placebo|||3.4|-1.6|0.4851
74075865|NCT03956862|147705217|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.3898|TWO_SIDED|95.0|0.136|2.178|||Regression, Cox||GB001 vs Placebo|||2.178|0.136|0.3898
74075866|NCT02129426|147705220|OTHER|t-test comparison of the two groups||||||0.96|||||||t-test, 1 sided|||||||0.96
74075867|NCT02129426|147705221|OTHER|||||||0.52|||||||t-test, 1 sided|||||||0.52
74075868|NCT00850174|147705275|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.48||||||90.0|88.98|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.00|88.98|
74075869|NCT00850174|147705276|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.54||||||90.0|99.19|106.01|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.01|99.19|
74075870|NCT00850174|147705277|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.19||||||90.0|98.78|105.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.71|98.78|
74075871|NCT00850174|147705278|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.77||||||90.0|97.03|104.65|||||Results presented for informational purposes only; metabolite not subjected to Bioequivalence criteria.|||104.65|97.03|
74075872|NCT00850174|147705279|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.94||||||90.0|97.75|102.18|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.|||102.18|97.75|
74075873|NCT00850174|147705280|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.8||||||90.0|97.5|102.15|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||102.15|97.50|
74075874|NCT01363765|147705283|SUPERIORITY_OR_OTHER||notification rate ratio|1.59|||<|0.01|TWO_SIDED|95.0|1.32|1.87||NR were calculated using an aggregated database consisting of 896 strata for laboratory (n=14), study month (n=8), sex (n=2) and age group (n=4: \<15, 15-39, 40-59, and \>=60 years). Poisson regression modeling was used to analyze changes in TB TB NR|Clustered Avareged|Adjustment for municipality, age, sex, and baseline proportion of samples with a positive smear was by a population-averaged quasi-likelihood approach|"The numbers reported in the CONSORT flowchart refer to the diagnostic samples. NR were obtained crosslinking lab and notification databases, denominator was population/year."|cluster-averaged NNR=1.59 (CI95% 1.31-1.88) Absolute numbers informed in table do not allow calculation of notification rates; they are based on population size, not in total numbers and percentages||1.87|1.32|<0.01
74075875|NCT01363765|147705283|SUPERIORITY_OR_OTHER||notification rate ratio|1.7|||<|0.001|TWO_SIDED|95.0|1.51|1.92|||Mixed Models Analysis|Mixed multi-level model, time-adjusted||Secondary analysis: Mixed multi-level model||1.92|1.51|<0.001
74075876|NCT01363765|147705284|SUPERIORITY_OR_OTHER||incremental cost-effectiveness ratio|-84.07||||||95.0||||||Incremental cost-effectiveness ratio (ICER) per case detected||||||
74075877|NCT01363765|147705285|SUPERIORITY_OR_OTHER||NRR|0.98||||0.923|TWO_SIDED|95.0|0.64|1.32||cluster-averaged adjusted NRR (notification rate ratio, not calculable from number shown, which are a proportion of tests. NRR calculated over a population/year denominator.|Agregated cluster-averaged|||||1.32|0.64|0.923
74075878|NCT01363765|147705286|SUPERIORITY_OR_OTHER||NRR|0.52||||0.004|TWO_SIDED|95.0|0.21|0.84||cluster-averaged adjusted NRR|Agregated cluster-averaged|||||0.84|0.21|0.004
74075879|NCT00635492|147705294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16|||<|0.0001|TWO_SIDED|95.0|1.13|1.19|||Regression, Logistic|||Body Mass Index (BMI) - 1kg/m² higher||1.19|1.13|<0.0001
74075880|NCT00635492|147705295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86|||Regression, Logistic|||Most recent HbA1c at baseline - 1% higher.||0.86|0.69|<0.0001
74075881|NCT00635492|147705296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96|||<|0.0001|TWO_SIDED|95.0|0.95|0.97|||Regression, Logistic|||Age - 1 year older||0.97|0.95|<0.0001
74075882|NCT00635492|147705297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.0083|TWO_SIDED|95.0|1.01|1.1|||Regression, Logistic|||Diabetes Health Profile - 18 (DHP-18) subscale disinhibited eating - Yes vs. No||1.10|1.01|0.0083
74075883|NCT00635492|147705298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.0141|TWO_SIDED|95.0|0.9|0.99|||Regression, Logistic|||Random blood glucose - 1 mmol/L higher||0.99|0.90|0.0141
74075884|NCT00635492|147705299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.0107|TWO_SIDED|95.0|0.96|0.99|||Regression, Logistic|||Blood glucose self-monitoring - 1 test/week more||0.99|0.96|0.0107
74075885|NCT00635492|147705300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.0193|TWO_SIDED|95.0|1.13|2.46|||Regression, Logistic|||Receipt of diet/exercise advice - Yes vs. No||2.46|1.13|0.0193
74075886|NCT00635492|147705301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.0138|TWO_SIDED|95.0|0.72|0.96|||Regression, Logistic|||LDL cholesterol - 1 mmol/L higher at baseline||0.96|0.72|0.0138
74075887|NCT00635492|147705309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.118|||<|0.0001|TWO_SIDED|95.0|1.062|1.177|||Regression, Cox|||HbA1c (%) at baseline||1.177|1.062|<0.0001
74075888|NCT00635492|147705309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.001|TWO_SIDED|95.0|0.937|0.985|||Regression, Cox|||DHP barriers to activity subscale at baseline||0.985|0.937|0.001
74075889|NCT00635492|147705309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.532|||<|0.001|TWO_SIDED|95.0|1.698|3.777|||Regression, Cox|||Gastrointestinal symptoms: yes vs. no at baseline||3.777|1.698|<0.001
74075890|NCT00635492|147705309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.437|||<|0.001|TWO_SIDED|95.0|0.303|0.63|||Regression, Cox|||Insulin regimen: basal/bolus vs. long-acting only||0.630|0.303|<0.001
74075891|NCT00635492|147705309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.676||||0.003|TWO_SIDED|95.0|0.523|0.874|||Regression, Cox|||Insulin regimen: mixtures vs. long-acting only||0.874|0.523|0.003
74075892|NCT00635492|147705309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.549||||0.303|TWO_SIDED|95.0|0.175|1.718|||Regression, Cox|||Insulin regimen: other vs. long-acting only||1.718|0.175|0.303
74075893|NCT00635492|147705309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.164|||<|0.001|TWO_SIDED|95.0|1.681|2.785|||Regression, Cox|||Insulin regimen: short-acting only vs. long-acting only||2.785|1.681|<0.001
74075894|NCT00635492|147705310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.463||||0.028|TWO_SIDED|95.0|1.043|2.053|||Regression, Cox|||GI symptoms: yes vs. no at baseline||2.053|1.043|0.028
74075895|NCT00635492|147705310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601||||0.002|TWO_SIDED|95.0|0.432|0.834|||Regression, Cox|||EQ-5D index value at baseline||0.834|0.432|0.002
74075896|NCT02169115|147705320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|1.7||0.05|TWO_SIDED||||||ANOVA|||||||0.05
74075897|NCT02169115|147705320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|1.8||0.005|TWO_SIDED||||||ANOVA|||||||0.005
74075898|NCT02169115|147705320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|1.4|||TWO_SIDED|||||||||||||
74075899|NCT05169710|147705343|SUPERIORITY||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|2.857||0.1718|TWO_SIDED|95.0|-9.64|1.75|||Mixed Models Analysis|||||1.75|-9.64|0.1718
74075900|NCT05169710|147705343|SUPERIORITY||Mean Difference (Final Values)|-6.34|STANDARD_ERROR_OF_MEAN|2.837||0.0286|TWO_SIDED|95.0|-11.99|-0.68|||Mixed Models Analysis|||||-0.68|-11.99|0.028600
74075901|NCT05169710|147705344|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.308||0.7314|TWO_SIDED|95.0|-0.72|0.51|||Mixed Models Analysis|||||0.51|-0.72|0.7314
74075902|NCT05169710|147705344|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.305||0.3169|TWO_SIDED|95.0|-0.91|0.3|||Mixed Models Analysis|||||0.3|-0.91|0.3169
74075903|NCT02729714|147705346|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
74075904|NCT02729714|147705347|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
74075905|NCT02729714|147705348|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
74075906|NCT02729714|147705349|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
74075907|NCT02729714|147705350|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
74075908|NCT02729714|147705351|SUPERIORITY|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||||||0.098
74075909|NCT02729714|147705352|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
74075910|NCT00836056|147705365|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.75||||||90.0|91.5|104.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.42|91.50|
74075911|NCT00836056|147705366|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.77||||||90.0|91.4|102.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.46|91.40|
74075912|NCT00836056|147705367|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|95.96||||||90.0|90.77|101.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.46|90.77|
74075913|NCT01686438|147705376|NON_INFERIORITY|The mean change in ISI score from baseline in Veterans receiving CBT-I by video teleconferencing will be no more than 1.67 smaller than the reference treatment, i.e., Veterans receiving in-person CBT-I.|Mean Difference (Net)|-2.03|STANDARD_DEVIATION|1.33||0.138|TWO_SIDED|95.0|-4.63|1.57|||t-test, 1 sided|||||1.57|-4.63|0.138
74075914|NCT02648347|147705411|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.048|||TWO_SIDED|95.0|-0.04|0.15||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.15|-0.04|
74075915|NCT02648347|147705412|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.3 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|1.16|||=|0.205|TWO_SIDED|95.0|0.955|1.412|||Log Rank|||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.412|0.955|=0.2050
74075916|NCT02648347|147705412|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.17|||=|0.0725|TWO_SIDED|95.0|1.012|1.355|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 382 and 344 respectively; median time to first event (Q1, Q3) = 50.07 (23.00, 82.86) weeks versus 51.93 (27.79, 91.00) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.355|1.012|=0.0725
74075917|NCT02648347|147705413|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.06|0.14||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.14|-0.06|
74075918|NCT02648347|147705414|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.1743|TWO_SIDED|95.0|0.966|1.382|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.382|0.966|=0.1743
74075919|NCT02648347|147705414|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.2305|TWO_SIDED|95.0|0.972|1.267|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE plus hospitalization for heart failure or thromboembolic events excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 451 and 424 respectively; median time to first event (Q1, Q3) = 42.86 (19.71, 73.43) weeks versus 43.86 (21.36, 80.43) weeks, respectively.||1.267|0.972|=0.2305
74075920|NCT02648347|147705415|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.19|||=|0.3154|TWO_SIDED|95.0|0.901|1.564|||Gray's Test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.564|0.901|=0.3154
74075921|NCT02648347|147705415|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.2531|TWO_SIDED|95.0|0.947|1.42|||Gray's Test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 198 and 178 respectively; median time to first event (Q1, Q3) = 45.57 (21.71, 73.29) weeks versus 47.36 (20.00, 88.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.420|0.947|=0.2531
74075922|NCT02648347|147705416|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.13|||=|0.5991|TWO_SIDED|95.0|0.808|1.594|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.594|0.808|=0.5991
74075923|NCT02648347|147705416|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.01|||=|0.8613|TWO_SIDED|95.0|0.792|1.293|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 127 and 131 respectively; median time to first event (Q1, Q3) = 48.29 (28.86, 76.14) weeks versus 48.43 (21.29, 92.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.293|0.792|=0.8613
74075924|NCT02648347|147705417|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.4388|TWO_SIDED|95.0|0.902|1.375|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.375|0.902|=0.4388
74075925|NCT02648347|147705417|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.09|||=|0.4577|TWO_SIDED|95.0|0.93|1.274|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 319 and 307 respectively; median time to first event (Q1, Q3) = 52.14 (28.71, 84.71) weeks versus 53.00 (30.71, 94.14) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.274|0.930|=0.4577
74075926|NCT01265056|147705433|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
74075927|NCT01265056|147705433|SUPERIORITY||||||<|0.04|||||||Regression, Logistic|||||||<0.04
74075928|NCT01265056|147705434|SUPERIORITY||||||<|0.8|||||||t-test, 2 sided|||||||<0.8
74075929|NCT01265056|147705435|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
74075930|NCT01416584|147705436|SUPERIORITY||Odds Ratio (OR)|1.4||||0.6|TWO_SIDED|95.0|0.4|4.83|||General Estimating Equation (GEE)|||||4.83|0.40|0.60
74075931|NCT01416584|147705436|SUPERIORITY||Odds Ratio (OR)|1.1||||0.88|TWO_SIDED|95.0|0.32|3.73|||General Estimating Equation (GEE)|||||3.73|0.32|0.88
74075932|NCT01416584|147705436|SUPERIORITY||Odds Ratio (OR)|1.27||||0.64|TWO_SIDED|95.0|0.36|4.46|||General Estimating Equation (GEE)|||||4.46|0.36|0.64
74075933|NCT01416584|147705437|SUPERIORITY||Odds Ratio (OR)|0.39||||0.02|TWO_SIDED|95.0|0.38|0.41|||General Estimating Equation (GEE)|||||0.41|0.38|0.02
74075934|NCT01416584|147705437|SUPERIORITY||Odds Ratio (OR)|0.73||||0.39|TWO_SIDED|95.0|0.34|1.57|||General Estimating Equation (GEE)|||||1.57|0.34|0.39
74075935|NCT01416584|147705437|SUPERIORITY||Odds Ratio (OR)|1.86||||0.1|TWO_SIDED|95.0|1.53|2.26|||General Estimating Equation (GEE)|||||2.26|1.53|0.10
74075936|NCT01416584|147705438|SUPERIORITY||Odds Ratio (OR)|0.37||||0.02|TWO_SIDED|95.0|0.36|0.38|||General Estimating Equation (GEE)|||||0.38|0.36|0.02
74075937|NCT01416584|147705438|SUPERIORITY||Odds Ratio (OR)|0.39||||0.02|TWO_SIDED|95.0|0.38|0.41|||General Estimating Equation (GEE)|||||0.41|0.38|0.02
73884997|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.45|TWO_SIDED|95.0|-4.08|1.82||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.82|-4.08|0.450
73884998|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73||||0.218|TWO_SIDED|95.0|-4.49|1.04||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.04|-4.49|0.218
73884999|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.747|TWO_SIDED|95.0|-0.36|0.26||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.26|-0.36|0.747
74075938|NCT01416584|147705438|SUPERIORITY||Odds Ratio (OR)|1.07||||0.85|TWO_SIDED|95.0|0.2|5.66|||General Estimating Equation (GEE)|||||5.66|0.20|0.85
74075939|NCT01416584|147705439|SUPERIORITY||Odds Ratio (OR)|0.35||||0.01|TWO_SIDED|95.0|0.34|0.35|||General Estimating Equation (GEE)|||||0.35|0.34|0.01
74075940|NCT01416584|147705439|SUPERIORITY||Odds Ratio (OR)|0.41||||0.03|TWO_SIDED|95.0|0.39|0.44|||General Estimating Equation (GEE)|||||0.44|0.39|0.03
74075941|NCT01416584|147705439|SUPERIORITY||Odds Ratio (OR)|0.84||||0.63|TWO_SIDED|95.0|0.42|1.69|||General Estimating Equation (GEE)|||||1.69|0.42|0.63
74075942|NCT01416584|147705440|SUPERIORITY||Odds Ratio (OR)|0.4||||0.01|TWO_SIDED|95.0|0.39|0.4|||General Estimating Equation (GEE)|||||0.40|0.39|0.01
74075943|NCT01416584|147705440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.37|TWO_SIDED|95.0|0.36|1.55|||General Estimating Equation (GEE)|||||1.55|0.36|0.37
74075944|NCT01416584|147705440|SUPERIORITY||Odds Ratio (OR)|0.53||||0.05|TWO_SIDED|95.0|0.28|1.0|||General Estimating Equation (GEE)|||||1.00|0.28|0.05
74075945|NCT02601560|147705451|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANCOVA|||||||0.095
74075946|NCT02601560|147705451|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
74075947|NCT02601560|147705451|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
74075948|NCT02601560|147705451|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
74075949|NCT02601560|147705451|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANCOVA|||||||0.440
74075950|NCT02601560|147705451|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
74075951|NCT00833937|147705496|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|99.7||||||90.0|93.9|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|93.9|
74075952|NCT00833937|147705497|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.8||||||90.0|92.6|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|92.6|
74075953|NCT00833937|147705498|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.9||||||90.0|92.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|92.7|
74075954|NCT04544787|147705510|OTHER|||||||0.7209|||||||Fisher Exact|||The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.||||0.7209
74075955|NCT04544787|147705510|OTHER|||||||0.7209|||||||Fisher Exact|||The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.||||0.7209
74075956|NCT04544787|147705510|OTHER|||||||0.3769|||||||Fisher Exact|||The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.||||0.3769
74075957|NCT04544787|147705510|OTHER|||||||0.3083|||||||Fisher Exact|||The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.||||0.3083
74075958|NCT04544787|147705510|OTHER|||||||0.4975|||||||Fisher Exact|||The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.||||0.4975
73885000|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.39|TWO_SIDED|95.0|-0.18|0.45||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.45|-0.18|0.390
73885001|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.228|TWO_SIDED|95.0|-0.12|0.49||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.49|-0.12|0.228
73885002|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.26|TWO_SIDED|95.0|-0.18|0.67||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.67|-0.18|0.260
74075959|NCT04544787|147705510|OTHER|||||||1|||||||Fisher Exact|||The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.||||1.0000
74075960|NCT04544787|147705510|OTHER|||||||1|||||||Fisher Exact|||Comparison of severe solicited adverse events||||1.0000
74075961|NCT04544787|147705510|OTHER|||||||1|||||||Fisher Exact|||Comparison of severe solicited adverse events||||1.0000
74075962|NCT04544787|147705510|OTHER|||||||0.1571|||||||Fisher Exact|||Comparison of severe unsolicited adverse events||||0.1571
74075963|NCT04544787|147705510|OTHER|||||||0.296|||||||Fisher Exact|||Comparison of severe unsolicited adverse events||||0.2960
74075964|NCT04544787|147705511|NON_INFERIORITY|The primary immunogenicity endpoint, seroprotection on Day 28 after a single dose of each vaccine candidate, was formally compared with the corresponding endpoint from UAM1 via a non-inferiority test of the difference of each of the novel candidates to the monovalent OPV2 control, mOPV2, each using one-sided α=0.025 and a non-inferiority margin of 10%, computed using two-sided α=0·05 Miettinen and Nurminen score-based CIs for inference.|Difference|2.0|||||TWO_SIDED|95.0|-1.9|7.0||||||The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 (mOPV2) control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.||7.0|-1.9|
74075965|NCT04544787|147705511|NON_INFERIORITY|The primary immunogenicity endpoint, seroprotection on Day 28 after a single dose of each vaccine candidate, was formally compared with the corresponding endpoint from UAM1 via a non-inferiority test of the difference of each of the novel candidates to the monovalent OPV2 control, mOPV2, each using one-sided α=0.025 and a non-inferiority margin of 10%, computed using two-sided α=0·05 Miettinen and Nurminen score-based CIs for inference.|Difference|2.0|||||TWO_SIDED|95.0|-1.8|7.0||||||The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.||7.0|-1.8|
74075966|NCT02779543|147705636|EQUIVALENCE|this trial compared the 2 devices to the polysomnography, which is the gold standard|Mean value|368.3|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
74075967|NCT02779543|147705637|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|13.9|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
74075968|NCT02779543|147705638|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|106.0|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
74075969|NCT02779543|147705639|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|74.3|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
74075970|NCT03707912|147705640|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
74075971|NCT03707912|147705641|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
74075972|NCT03707912|147705642|SUPERIORITY|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
74075973|NCT03707912|147705642|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.98|||||||Breslow-Day test|||||||0.98
74075974|NCT03707912|147705643|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
74075975|NCT03707912|147705644|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
74075976|NCT03707912|147705644|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.75|||||||Breslow-Day test|||||||0.75
74075977|NCT03707912|147705645|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Day 1 comparison.||||0.89
74075978|NCT03707912|147705645|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Day 2 comparison.||||0.75
74075979|NCT03707912|147705645|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Day 3 comparison.||||0.34
74075980|NCT03707912|147705646|SUPERIORITY|||||||0.75|||||||Fisher Exact|||||||0.75
74075981|NCT01513174|147705760|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.124|TWO_SIDED|95.0|1.0|1.92|||Log Rank||||The initial hypothesis estimated that the median PFS for the gefitinib group would be 10 months, while the median PFS for the gefitinib/olaparib group would be 16 months, which implied a hazard ratio (HR) of 1.6.|1.92|1.00|0.124
74075982|NCT01513174|147705761|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.3455|TWO_SIDED|95.0|0.806|1.845|||Log Rank|||||1.845|0.806|0.3455
74075983|NCT00467363|147705763|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0984|TWO_SIDED|95.0|0.98|1.22||Only one outcome for primary outcome, so no adjustment of p-value for multiple comparisons was done. A priori threshold for statistical significance was p\<0.05.|Fisher Exact|No adjustments were done. Treatment groups were similar with respect to the assessed demographic and baseline characteristics||The study was designed to detect a 10% absolute difference in livebirth rate with 80% power and a type I error rate of 5%, on the assumption that participants taking placebo who achieved pregnancy would have a livebirth rate of 75%.||1.22|0.98|0.0984
74075984|NCT00467363|147705764|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0165|TWO_SIDED|95.0|1.02|1.19|||Fisher Exact|||||1.19|1.02|.0165
74075985|NCT00467363|147705765|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0329|TWO_SIDED|95.0|1.01|1.19|||Fisher Exact|||||1.19|1.01|.0329
74075986|NCT00467363|147705766|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.8902|TWO_SIDED|95.0|0.64|1.78|||Fisher Exact|||||1.78|.64|.8902
74075987|NCT00467363|147705767|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08||||0.6869|TWO_SIDED|95.0|0.76|1.55|||Fisher Exact|||||1.55|.76|.6869
74075988|NCT00467363|147705768|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.753|TWO_SIDED|95.0|0.19|2.41|||Fisher Exact|||||2.41|.19|.7530
74075989|NCT00467363|147705769|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.15|7.26|||Fisher Exact|||||7.26|.15|1.000
74075990|NCT00467363|147705770|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.21|5.06|||Fisher Exact|||||5.06|.21|1.000
74075991|NCT00467363|147705771|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.21|5.06|||Fisher Exact|||||5.06|.21|1.000
74075992|NCT00467363|147705772|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08||||0.7943|TWO_SIDED|95.0|0.67|1.76|||Fisher Exact|||||1.76|.67|.7943
74075993|NCT00467363|147705773|SUPERIORITY_OR_OTHER|||||||0.7802|||||||t-test, 2 sided|||||||.7802
74075994|NCT00467363|147705774|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.72||||0.2603|TWO_SIDED|95.0|0.42|1.23|||Fisher Exact|||||1.23|.42|.2603
74075995|NCT00467363|147705777|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3||||0.77|TWO_SIDED|95.0|-0.8|1.4|||Fisher Exact|||||1.4|-0.8|0.77
74075996|NCT04405570|147705792|SUPERIORITY|||||||0.5551|||||||Log Rank|||||||0.5551
74075997|NCT04405570|147705792|SUPERIORITY|||||||0.727|||||||Log Rank|||||||0.7270
74075998|NCT04405570|147705792|SUPERIORITY|||||||0.0128|||||||Log Rank|||||||0.0128
74075999|NCT04499963|147705796|SUPERIORITY|||||||0.984|||||||t-test, 2 sided|||We compared he ALSFRS-R slope (not the actual score) of the patients in our open label treatment versus the historical controls.||||0.984
74076000|NCT04499963|147705801|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
74076001|NCT04499963|147705802|OTHER||||||>|0.5||||||Alpha Diversity|Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.5
74076002|NCT04499963|147705803|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
74076003|NCT04499963|147705804|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
74076004|NCT04499963|147705805|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
74076005|NCT04499963|147705806|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
74076006|NCT04499963|147705807|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
74076007|NCT04499963|147705808|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
74076008|NCT03686033|147705836|SUPERIORITY||LS Mean difference|1.12|||||TWO_SIDED|90.0|-0.98|3.22||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (predose) measurement as a covariate, and subject nested within sequence as a random effect. Least Square (LS) Mean Difference was calculated for 2.5 mg versus (vs) Placebo only.||3.22|-0.98|
74076009|NCT03686033|147705836|SUPERIORITY||LS Mean difference|-4.17|||||TWO_SIDED|90.0|-6.35|-1.99||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (predose) measurement as a covariate, and subject nested within sequence as a random effect. LS Mean Difference was calculated for 25 mg vs Placebo only.||-1.99|-6.35|
74076010|NCT01045161|147705862|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.051||||0.019|TWO_SIDED|95.0|0.01|0.09|||ANCOVA|||||0.09|0.01|0.019
74076011|NCT01045161|147705862|SUPERIORITY_OR_OTHER||Least squares mean difference|0.072||||0.0012|TWO_SIDED|95.0|0.03|0.12|||ANCOVA|||||0.12|0.03|0.0012
74076012|NCT01045161|147705864|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.051||||0.0192|TWO_SIDED|95.0|0.01|0.09|||ANCOVA|||||0.09|0.01|0.0192
74076013|NCT01045161|147705864|SUPERIORITY_OR_OTHER||Least Squares Mean difference|0.072||||0.0012|TWO_SIDED|95.0|0.03|0.12|||ANCOVA|||||0.12|0.03|0.0012
74076014|NCT02612337|147705900|SUPERIORITY|The target sample size for each was 160 randomized subjects: 80 in each treatment group stratified by gender. The sample size estimate was chosen to achieve more than 90% power with a significance level of 0.05 2-sided to reject the null hypothesis of no treatment difference for the primary endpoint of DVD.|Risk Ratio (RR)|0.907||||0.623|TWO_SIDED|95.0|0.615|1.339|||Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||1.339|0.615|0.623
74076015|NCT02242201|147705906|SUPERIORITY|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
74076016|NCT02242201|147705906|SUPERIORITY|||||||0.662|||||||Wilcoxon (Mann-Whitney)|||||||0.662
74076017|NCT02242201|147705906|SUPERIORITY|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||||||0.103
74076018|NCT02242201|147705907|SUPERIORITY|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.948
74076019|NCT02242201|147705907|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.880
74076020|NCT02242201|147705907|SUPERIORITY|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.802
74076021|NCT02242201|147705907|SUPERIORITY|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.179
74076022|NCT02242201|147705907|SUPERIORITY|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.837
74076023|NCT02242201|147705907|SUPERIORITY|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.142
74076024|NCT02242201|147705907|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.010
74076025|NCT02242201|147705907|SUPERIORITY|||||||0.516|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.516
74076026|NCT02242201|147705907|SUPERIORITY|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.052
74076027|NCT02242201|147705907|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.840
74076028|NCT02242201|147705907|SUPERIORITY|||||||0.744|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.744
74076029|NCT02242201|147705907|SUPERIORITY|||||||0.501|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.501
74076030|NCT02242201|147705907|SUPERIORITY|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.358
74076031|NCT02242201|147705907|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.536
74076032|NCT02242201|147705907|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.110
74076033|NCT02242201|147705907|SUPERIORITY|||||||0.313|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.313
74076034|NCT02242201|147705907|SUPERIORITY|||||||0.893|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.893
74076035|NCT02242201|147705907|SUPERIORITY|||||||0.232|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.232
74076036|NCT02242201|147705908|SUPERIORITY|||||||0.772|||||||Kruskal-Wallis|||||||0.772
74076037|NCT02242201|147705909|SUPERIORITY|||||||0.251|||||||Regression, Cox|||Baseline||||0.251
74076038|NCT02242201|147705909|SUPERIORITY|||||||0.3|||||||Regression, Cox|||3 month follow-up||||0.300
74076039|NCT02242201|147705909|SUPERIORITY|||||||0.113|||||||Regression, Cox|||Baseline vs 3 months||||0.113
74076040|NCT02242201|147705909|SUPERIORITY|||||||0.147|||||||Regression, Cox|||Baseline vs 3 months||||0.147
74076041|NCT02242201|147705909|SUPERIORITY|||||||0.216|||||||Regression, Cox|||Baseline vs 3 months||||0.216
74076042|NCT02242201|147705909|SUPERIORITY|||||||0.968|||||||Regression, Cox|||Baseline vs 3 months||||0.968
74076043|NCT02242201|147705910|SUPERIORITY|||||||0.776|||||||Kruskal-Wallis|||Pain at rest||||0.776
74076044|NCT02242201|147705910|SUPERIORITY|||||||0.447|||||||Kruskal-Wallis|||Pain with movement||||0.447
74076045|NCT02242201|147705911|SUPERIORITY|||||||0.986|||||||ANOVA|||||||0.986
74076046|NCT02242201|147705911|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
74076047|NCT02242201|147705911|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
74076048|NCT02242201|147705911|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
74076049|NCT02242201|147705912|SUPERIORITY|||||||0.898|||||||ANOVA|||||||0.898
74076050|NCT02242201|147705912|SUPERIORITY|||||||0.112|||||||t-test, 1 sided|||Baseline vs 3 months||||0.112
74076051|NCT02242201|147705912|SUPERIORITY|||||||0.046|||||||t-test, 1 sided|||Baseline vs 3 months||||0.046
74076052|NCT02242201|147705912|SUPERIORITY|||||||0.026|||||||t-test, 1 sided|||Baseline vs 3 months||||0.026
74076053|NCT02242201|147705913|SUPERIORITY|||||||0.843|||||||Fisher Exact|||Operative extremity neurologic changes||||0.843
74076054|NCT02242201|147705913|SUPERIORITY|||||||1|||||||Fisher Exact|||Wound infection||||1.00
74076055|NCT02242201|147705913|SUPERIORITY|||||||1|||||||Fisher Exact|||Fall requiring medical attention||||1.00
74076056|NCT02242201|147705914|SUPERIORITY|||||||1|||||||Fisher Exact|||Pain at rest||||1.00
74076057|NCT02242201|147705914|SUPERIORITY|||||||0.167|||||||Fisher Exact|||Pain with movement||||0.167
74076058|NCT01424644|147705921|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to diphtheria toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates \[(MenACWY-CRM+Tdap+HPV) minus (Placebo+Tdap + HPV)\] was greater than -10%, at 1 month after Tdap vaccination|Vaccine group difference|13.0|||||TWO_SIDED|95.0|9.0|17.0|||Miettinen and Nurminen|||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo||17|9|
74076059|NCT01424644|147705921|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to tetanus toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates \[(MenACWY-CRM+ Tdap+HPV) minus (Placebo+Tdap + HPV)\] was greater than -10%, at 1 month after Tdap vaccination.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||2|-2|
74076060|NCT01424644|147705922|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to PT antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the ratio of the GMCs of the MenACWY-CRM +Tdap+HPV group to the Placebo+Tdap + HPV group was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio-Geometric mean conc|1.01|||||TWO_SIDED|95.0|0.89|1.14|||ANOVA|||Non-inferiority of anti-PT immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||1.14|0.89|
74076061|NCT01424644|147705922|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to FHA antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference \[(MenACWY-CRM +Tdap+HPV) minus(Placebo+Tdap + HPV)\] was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio- Geometric mean conc|0.84|||||TWO_SIDED|95.0|0.76|0.93|||ANOVA|||Non-inferiority of anti-FHA immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||0.93|0.76|
74076062|NCT01424644|147705922|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to PRN antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference \[(MenACWY-CRM+Tdap+HPV) minus(Placebo+Tdap + HPV)\] was greater than 0.5, at 1 month after vaccination.|Vaccine group ratio-Geometric mean conc|0.82|||||TWO_SIDED|95.0|0.72|0.93|||ANOVA|||Non-inferiority of anti-PRN immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||0.93|0.72|
74076063|NCT02298322|147705943|OTHER||sucess proportion|91.4|||<|0.0001|TWO_SIDED|95.0|86.2|95.1|||t-test, 1 sided|||||95.1|86.2|<0.0001
74076064|NCT00440297|147705952|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|48.5||||||95.0|38.4|58.7|||||Exact binomial confidence interval.|No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose among subjects who were seronegative at baseline||58.7|38.4|
74076065|NCT00440297|147705952|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|57.7||||||95.0|47.9|67.0|||||Exact binomial confidence interval.|||67.0|47.9|
73888528|NCT05465317|147309657|OTHER||Hazard Ratio (HR)|0.59||||0.31|TWO_SIDED|95.0|0.21|1.64|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.64|0.21|0.31
74076066|NCT00440297|147705953|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|66.7||||||95.0|56.5|75.8|||||Exact binomial confidence interval|||75.8|56.5|
74076067|NCT00440297|147705953|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|69.2||||||95.0|59.4|77.9|||||Exact binomial confidence interval|||77.9|59.4|
74076068|NCT02024932|147705959|SUPERIORITY_OR_OTHER_LEGACY||Geo-mean ratio|1.037||||0.0164|TWO_SIDED|90.0|1.009|1.065|||ANCOVA|||||1.065|1.009|0.0164
74076069|NCT03020641|147705996|OTHER|t-test|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2347||0.058|TWO_SIDED|95.0||0.1276||the threshold for statistical significance was p\<=0.05.|t-test, 2 sided|||Interleukin 1 (IL1)||0.1276|- 0.8077|0.058
74076070|NCT03020641|147705996|OTHER|Interleukin 6 (IL6)|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.29||0.001|TWO_SIDED|95.0|-1.6|-0.44|||t-test, 2 sided|||||-0.44|-1.60|0.001
74076071|NCT03020641|147705996|OTHER||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.211||0.052|TWO_SIDED|95.0|-0.76|0.81|||t-test, 2 sided|||Interleukin 10||0.81|-0.76|0.052
74076072|NCT03020641|147705996|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.181||0.815|TWO_SIDED|95.0|-0.5|0.22|||t-test, 2 sided|||Vascular Endotelial Grow Factor A||0.22|-0.50|0.815
73885003|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.141|TWO_SIDED|95.0|-0.76|0.11||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.11|-0.76|0.141
73885004|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.007|TWO_SIDED|95.0|-0.98|-0.16||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||-0.16|-0.98|0.007
73885005|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.409|TWO_SIDED|95.0|-0.61|0.25||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.25|-0.61|0.409
73885006|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.715|TWO_SIDED|95.0|-0.51|0.35||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.35|-0.51|0.715
73885007|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.641|TWO_SIDED|95.0|-0.32|0.52||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.52|-0.32|0.641
73888529|NCT05465317|147309657|OTHER||Hazard Ratio (HR)|1.16||||0.76|TWO_SIDED|95.0|0.46|2.92|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.92|0.46|0.76
74076073|NCT03020641|147705996|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.742|TWO_SIDED|95.0|-0.42|0.36|||t-test, 2 sided|||TNF alfa||0.36|-0.42|0.742
74076074|NCT03020641|147705996|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.2||0.603|TWO_SIDED|95.0|-0.36|0.44|||t-test, 2 sided|||Chemokine CXC ligand 2||0.44|-0.36|0.603
74076075|NCT03020641|147705997|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|95.0|-0.47|0.65|||t-test, 2 sided|||Matrix metalloproteinase-9||0.65|-0.47|0.600
74076076|NCT03020641|147705997|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.24||0.028|TWO_SIDED|95.0|0.03|0.97|||t-test, 2 sided|||Plasminogen activator inhibitor-1||0.97|0.030|0.028
74076077|NCT03020641|147705997|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.36||0.807|TWO_SIDED|95.0|-0.64|0.82|||t-test, 2 sided|||E-selectin||0.82|-0.64|0.807
74076078|NCT03020641|147705999|OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|4.44||0.862|TWO_SIDED|95.0|-7.49|10.21|||t-test, 2 sided|||||10.21|-7.49|0.862
74076079|NCT00939003|147706055|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74076080|NCT00939003|147706056|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
74076081|NCT00939003|147706057|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
74076082|NCT00939003|147706058|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.001
74076083|NCT00939003|147706059|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Chi-squared|||||||0.014
74076084|NCT00939003|147706062|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
74076085|NCT00939003|147706063|SUPERIORITY_OR_OTHER|||||||0.027|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.027
74076086|NCT00939003|147706064|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||<0.001
74076087|NCT00939003|147706065|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.003
74076088|NCT00939003|147706066|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.001
74076089|NCT02934347|147706077|SUPERIORITY_OR_OTHER||||||>|0.05||||||Grades analysed were 1, 2 and then 3 and 4 combined because of low frequencies in the latter two grades|Chi-squared, Corrected|Chi-squared for trend||Null hypothesis: no difference in frequency of grade of glottic view between the supine and back-up positions||||>0.05
74076090|NCT02934347|147706078|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|df=3||||||<0.01
74076091|NCT02934347|147706079|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
74076092|NCT02934347|147706080|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73885008|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.767|TWO_SIDED|95.0|-0.64|0.47||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.47|-0.64|0.767
74076093|NCT00837486|147706085|SUPERIORITY_OR_OTHER||||||=|0.53||||||"one-sided P-value~per protocol responder rates: Active Group = 20.0%, Control Group = 14.3%"|Fisher Exact|||The study originally required a sample size of 208 subjects in order to have 90% power to detect a statistically significant difference between the responder rate of the active and control groups. With this 30-subject cohort, and only 29 subjects completing the blinded-treatment phase per protocol, the comparison of response rates was not adequately powered. The P-value is presented only to describe the outcomes of the two groups.||||=0.53
74076094|NCT00819741|147706138|NON_INFERIORITY_OR_EQUIVALENCE|"If non-inferiority was shown (that was if H0 was rejected), then superiority of repaglinide and metformin combination therapy compared to repaglinide monotherapy would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.~The non-inferiority margin for HbA1c was set to 0.4%."|Estimated treatment difference, LS Mean|-0.302|STANDARD_ERROR_OF_MEAN|0.0096||||95.0|-0.491|-0.114|||ANCOVA|||"The non-inferiority margin for HbA1c was set to 0.4%.~The null hypothesis (H0) was:~H0: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment ≥0.4%~Against the alternative hypothesis (H1):~H1: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment \<0.4%"||-0.114|-0.491|
74076095|NCT00119015|147706153|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8
74076096|NCT00119015|147706154|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.70
74076097|NCT00119015|147706155|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
74076098|NCT00119015|147706156|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.48
74076099|NCT00119015|147706157|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.99
74076100|NCT01597245|147706158|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076101|NCT01597245|147706158|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076102|NCT01597245|147706158|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076103|NCT01597245|147706159|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076104|NCT01597245|147706159|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076105|NCT01597245|147706159|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076106|NCT01597245|147706160|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.005
74076107|NCT01597245|147706160|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076108|NCT01597245|147706160|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076109|NCT01597245|147706161|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076110|NCT01597245|147706161|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076111|NCT01597245|147706161|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076112|NCT01597245|147706162|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.008
74076113|NCT01597245|147706162|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076114|NCT01597245|147706162|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076115|NCT01597245|147706163|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
74076116|NCT01597245|147706163|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
74076117|NCT01597245|147706164|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076118|NCT01597245|147706164|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076119|NCT01597245|147706164|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
74076120|NCT01597245|147706165|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076121|NCT01597245|147706165|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076122|NCT01597245|147706165|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076123|NCT01597245|147706166|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
74076124|NCT01597245|147706166|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076125|NCT01597245|147706166|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076126|NCT01597245|147706167|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076127|NCT01597245|147706167|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076128|NCT01597245|147706167|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076129|NCT01597245|147706168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076130|NCT01597245|147706168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076131|NCT01597245|147706168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076132|NCT01597245|147706169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED||||||ANCOVA|||||||0.150
74076133|NCT01597245|147706169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
74076134|NCT01597245|147706169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
74076135|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.026
74076136|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.076
74076137|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.016
74076138|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
74076139|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
74076140|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
74076141|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
74076142|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
74076143|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
74076144|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
74076145|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
74076146|NCT01597245|147706170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
74076147|NCT01597245|147706171|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
74076148|NCT01597245|147706171|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
74076149|NCT01597245|147706171|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
74076150|NCT01597245|147706171|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
74076151|NCT01597245|147706171|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
74076152|NCT01597245|147706171|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
74076153|NCT01597245|147706172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076154|NCT01597245|147706172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076155|NCT01597245|147706172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
74076156|NCT01597245|147706173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
74076157|NCT01597245|147706173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
74076158|NCT01597245|147706173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
74076159|NCT01597245|147706173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
74076160|NCT01597245|147706173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
74076161|NCT01597245|147706173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
74076162|NCT01597245|147706173|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||0.002
74076163|NCT01597245|147706173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||<0.001
74076164|NCT01597245|147706173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||<0.001
74076165|NCT00731783|147706177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||1|TWO_SIDED|95.0|0.54|1.97|||Fisher Exact|||||1.97|0.54|1.00
74076166|NCT00731783|147706178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.05|TWO_SIDED|95.0|1.03|4.55|||Fisher Exact|||||4.55|1.03|0.05
74076167|NCT00731783|147706179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.49|TWO_SIDED|95.0|0.39|1.52|||Fisher Exact|||||1.52|0.39|0.49
74076168|NCT00731783|147706180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.28|TWO_SIDED|95.0|0.77|3.28|||Fisher Exact|||||3.28|0.77|0.28
74076169|NCT00731783|147706181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.12|TWO_SIDED|95.0|0.23|1.16|||Fisher Exact|||||1.16|0.23|0.12
74076170|NCT00731783|147706182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.02|TWO_SIDED|95.0|0.21|0.85|||Fisher Exact|||||0.85|0.21|0.02
74076171|NCT00731783|147706183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.008|TWO_SIDED|95.0|0.2|0.77|||Fisher Exact|||||0.77|0.20|0.008
74076172|NCT00731783|147706184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.02|TWO_SIDED|95.0|0.22|0.86|||Fisher Exact|||||0.86|0.22|0.02
74076173|NCT03235739|147706187|SUPERIORITY|multiple imputation for longitudinal data was conducted to impute the missing data for the primary outcome. The final results were obtained from pooling results from 10 imputed complete case data set.|geometric mean ratio|0.9||||0.84|TWO_SIDED|95.0|0.32|2.55|||Mixed Models Analysis|||||2.55|0.32|0.84
74076174|NCT03235739|147706187|SUPERIORITY|A sensitivity analysis using complete case analysis|geometric mean ratio|0.82||||0.73|TWO_SIDED|95.0|0.26|2.56|||Mixed Models Analysis|||||2.56|0.26|0.73
74076175|NCT03235739|147706188|SUPERIORITY||geometric mean ratio|1.02||||0.91|TWO_SIDED|98.3|0.63|1.67|||Mixed Models Analysis|||||1.67|0.63|0.91
74076176|NCT03235739|147706189|SUPERIORITY||Risk Ratio (RR)|2.58||||0.012|TWO_SIDED|98.3|0.98|6.8|||Chi-squared|||||6.80|0.98|0.012
74076177|NCT03235739|147706190|SUPERIORITY||median of differences|-5.0||||0.08|TWO_SIDED|98.3|-12.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-12|0.08
74076178|NCT00467896|147706207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.8|||<|0.0001|TWO_SIDED|95.0|39.55|60.15|||t-test, 2 sided|||Comparison of the change in inhalation-times rate from Period I (PD-6) to Period II (PD-15)||60.15|39.55|<0.0001
74076179|NCT03772522|147706208|SUPERIORITY||Cohen's d (effect size)|0.384||||0.428|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.428
74076180|NCT03772522|147706208|SUPERIORITY||Cohen's d (effect size)|-0.46||||0.058|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and immediately post-intervention.||||0.058
74076181|NCT03772522|147706208|SUPERIORITY||Cohen's d (effect size)|-0.4||||0.095|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 3-month post-intervention.||||0.095
74076182|NCT03772522|147706208|SUPERIORITY||Cohen's d (effect size)|-0.73||||0.005|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 6-months post-intervention.||||0.005
74076183|NCT03772522|147706208|SUPERIORITY||Cohen's d (effect size)|-0.6||||0.022|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 9-months post-intervention.||||0.022
74076184|NCT03772522|147706209|SUPERIORITY||Cohen's d (effect size)|1.792||||0.002|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the physical component of the CIS.||||0.002
74076185|NCT03772522|147706209|SUPERIORITY||Cohen's d (effect size)|0.047||||0.923|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the psychological component of the CIS.||||0.923
74076186|NCT03772522|147706209|SUPERIORITY||Cohen's d (effect size)|0.6||||0.18|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and immediately post-intervention.||||0.18
74076187|NCT03772522|147706209|SUPERIORITY||Cohen's d (effect size)|0.2||||0.388|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and immediately post-intervention.||||0.388
74076188|NCT03772522|147706209|SUPERIORITY||Cohen's d (effect size)|0.52||||0.037|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 3-months post-intervention.||||0.037
74076189|NCT03772522|147706209|SUPERIORITY||Cohen's d (effect size)|0.09||||0.688|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 3-months post-intervention.||||0.688
74076190|NCT03772522|147706209|SUPERIORITY||Cohen's d (effect size)|0.51||||0.038|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 6-months post-intervention.||||0.038
74076191|NCT03772522|147706209|SUPERIORITY||Cohen's d (effect size)|0.01||||0.956|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 6-months post-intervention.||||0.956
74076192|NCT03772522|147706209|SUPERIORITY||Cohen's d (effect size)|0.32||||0.197|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 9-months post-intervention.||||0.197
74076193|NCT03772522|147706209|SUPERIORITY||Cohen's d (effect size)|-0.07||||0.762|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 9-months post-intervention.||||0.762
74076194|NCT03772522|147706210|SUPERIORITY||Cohen's d (effect size)|0.101||||0.834|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.834
74076195|NCT03772522|147706210|SUPERIORITY||Cohen's d (effect size)|0.19||||0.417|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and immediately post-intervention.||||0.417
74076196|NCT03772522|147706210|SUPERIORITY||Cohen's d (effect size)|0.42||||0.087|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 3-months post-intervention.||||0.087
74076197|NCT03772522|147706210|SUPERIORITY||Cohen's d (effect size)|0.33||||0.168|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 6-months post-intervention.||||0.168
74076198|NCT03772522|147706210|SUPERIORITY||Cohen's d (effect size)|0.37||||0.133|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 9-months post-intervention.||||0.133
74076199|NCT03772522|147706211|SUPERIORITY||Cohen's d (effect size)|1.161||||0.026|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.026
74076200|NCT03772522|147706211|SUPERIORITY||Cohen's d (effect size)|0.62||||0.014|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and immediately post-intervention.||||0.014
74076201|NCT03772522|147706211|SUPERIORITY||Cohen's d (effect size)|0.29||||0.217|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 3-months post-intervention.||||0.217
73885009|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.881|TWO_SIDED|95.0|-0.61|0.52||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.52|-0.61|0.881
73885010|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.885|TWO_SIDED|95.0|-0.51|0.59||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.59|-0.51|0.885
73885011|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.325|TWO_SIDED|95.0|-0.96|0.32||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.32|-0.96|0.325
73885012|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.798|TWO_SIDED|95.0|-0.73|0.56||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.56|-0.73|0.798
74076202|NCT03772522|147706211|SUPERIORITY||Cohen's d (effect size)|0.71||||0.006|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 6-months post-intervention.||||0.006
74076203|NCT03772522|147706211|SUPERIORITY||Cohen's d (effect size)|0.53||||0.039|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 9-months post-intervention.||||0.039
74076204|NCT03818581|147706217|SUPERIORITY|||||||0.15|||||||SPCD analysis|||||||0.15
74076205|NCT01149473|147706239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.0|||||TWO_SIDED|90.0|98.1|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120|98.1|
74076206|NCT01149473|147706240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.0|||||TWO_SIDED|90.0|98.8|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106|98.8|
74076207|NCT01149473|147706241|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.0|||||TWO_SIDED|90.0|98.6|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104|98.6|
73888530|NCT05465317|147309658|OTHER||Hazard Ratio (HR)|1.72|||<|0.001|TWO_SIDED|95.0|1.58|1.88|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.88|1.58|<0.001
73885013|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.461|TWO_SIDED|95.0|-0.39|0.87||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.87|-0.39|0.461
74076208|NCT01149473|147706242|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||TWO_SIDED|90.0|98.8|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108|98.8|
74076209|NCT01149473|147706243|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|95.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101|98.6|
74076210|NCT01149473|147706244|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|90.0|98.7|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101|98.7|
74076211|NCT02757105|147706283|SUPERIORITY|||||||0.036|||||||Chi-squared, Corrected|||||||0.036
74076212|NCT02757105|147706284|SUPERIORITY|||||||0.41|||||||Chi-squared, Corrected|||||||0.410
74076213|NCT02757105|147706285|SUPERIORITY|||||||0.081|||||||Chi-squared, Corrected|||||||0.081
73888531|NCT05465317|147309658|OTHER||Hazard Ratio (HR)|1.84|||<|0.001|TWO_SIDED|95.0|1.48|2.3|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.30|1.48|<0.001
74076214|NCT02757105|147706286|SUPERIORITY|||||||0.042|||||||Chi-squared, Corrected|||||||0.042
74076215|NCT02757105|147706287|SUPERIORITY|||||||0.009|||||||Chi-squared, Corrected|||||||0.009
74076216|NCT02757105|147706288|SUPERIORITY|||||||0.919|||||||Chi-squared, Corrected|||||||0.919
74076217|NCT02757105|147706289|SUPERIORITY||Mean Difference (Final Values)|11.5||||0.278|TWO_SIDED|95.0|-7.7|30.6|||Chi-squared, Corrected|||||30.6|-7.7|0.278
74076218|NCT02757105|147706290|SUPERIORITY||Mean Difference (Final Values)|14.5||||0.135|TWO_SIDED|95.0|-3.4|32.5|||Chi-squared, Corrected|||||32.5|-3.4|0.135
74076219|NCT00473330|147706296|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.3|||<|0.0001|TWO_SIDED|95.0|13.8|34.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||34.8|13.8|<0.0001
74076220|NCT00473330|147706296|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|20.9||||0.0002|TWO_SIDED|95.0|10.7|31.1||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||31.1|10.7|0.0002
74076221|NCT00473330|147706297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001|TWO_SIDED|95.0|6.1|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.0|6.1|<0.0001
74076222|NCT00473330|147706297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|||<|0.0001|TWO_SIDED|95.0|6.2|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||12.6|6.2|<0.0001
74076223|NCT00473330|147706298|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.4|||<|0.0001|TWO_SIDED|95.0|13.4|35.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||35.4|13.4|<0.0001
74076224|NCT00473330|147706298|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|25.1|||<|0.0001|TWO_SIDED|95.0|14.0|36.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||36.3|14.0|<0.0001
73885014|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.67|TWO_SIDED|95.0|-1.02|0.66||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.66|-1.02|0.670
74076225|NCT00473330|147706299|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|8.2||||0.0086|TWO_SIDED|95.0|2.4|14.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||14.1|2.4|0.0086
74076226|NCT00473330|147706299|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|7.8||||0.0126|TWO_SIDED|95.0|2.0|13.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.6|2.0|0.0126
74076227|NCT00473330|147706300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.0005|TWO_SIDED|95.0|4.3|15.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||15.1|4.3|0.0005
74076228|NCT00473330|147706300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.2||||0.0011|TWO_SIDED|95.0|3.3|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||13.0|3.3|0.0011
74076229|NCT00473330|147706301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-107.9|||<|0.0001|TWO_SIDED|95.0|-149.2|-66.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-66.6|-149.2|<0.0001
74076230|NCT00473330|147706301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-119.1|||<|0.0001|TWO_SIDED|95.0|-159.6|-78.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-78.5|-159.6|<0.0001
74076231|NCT00473330|147706302|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-3.0||||0.159|TWO_SIDED|95.0|-6.7|0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||0.7|-6.7|0.1590
74076232|NCT00473330|147706302|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-2.5||||0.2721|TWO_SIDED|95.0|-6.5|1.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||1.4|-6.5|0.2721
74076233|NCT00473330|147706303|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|29.5|||<|0.0001|TWO_SIDED|95.0|21.1|38.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||38.0|21.1|<0.0001
73885015|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.243|TWO_SIDED|95.0|-1.37|0.35||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.35|-1.37|0.243
73885016|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.423|TWO_SIDED|95.0|-1.14|0.48||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.48|-1.14|0.423
73885017|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.333|TWO_SIDED|95.0|-1.04|0.35||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.35|-1.04|0.333
73885018|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.334|TWO_SIDED|95.0|-1.05|0.36||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.36|-1.05|0.334
74076234|NCT00473330|147706303|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.2|||<|0.0001|TWO_SIDED|95.0|16.7|31.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||31.7|16.7|<0.0001
73885019|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.69|0.68||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.68|-0.69|0.990
73885020|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.665|TWO_SIDED|95.0|-0.7|1.09||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||1.09|-0.70|0.665
73885021|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.7|TWO_SIDED|95.0|-1.1|0.74||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.74|-1.10|0.700
73885022|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.386|TWO_SIDED|95.0|-1.23|0.48||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.48|-1.23|0.386
73888532|NCT05465317|147309658|OTHER||Hazard Ratio (HR)|1.7|||<|0.001|TWO_SIDED|95.0|1.54|1.87|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.87|1.54|<0.001
73888533|NCT02593006|147309669|SUPERIORITY||Risk Difference (RD)|10.3|||>|0.05|TWO_SIDED|95.0|-3.2|23.8|||Propensity weighted regression model|||||23.8|-3.2|>0.05
73888534|NCT02593006|147309670|SUPERIORITY|||||||0.04||||||Global test of interaction between time and treatment group.|Mixed Models Analysis|||||||0.04
73888535|NCT01409707|147309677|SUPERIORITY_OR_OTHER||||||=|0.068||95.0||||The a priori threshold for statistical significance was set at p = .05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there'd be no differences between groups at posttreatment on posttraumatic stress disorder measures or alcohol use measures.||||=.068
74076235|NCT00473330|147706304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.7|-1.4|<0.0001
74076236|NCT00473330|147706304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.7|-1.5|<0.0001
74076237|NCT01975948|147706309|OTHER|||||||0.047||||||Adjusted for baseline depressive symptoms and unemployment as covariates (p=.016), and non-completers (missing one or more points of follow up data).|Mixed Models Analysis|||One hundred evaluable patients per arm were needed to achieve 80% power to detect a PHQ-9 between-group difference in mean change of 2 points, significance level (α) .05, a two-sided test, and a standard deviation of 5 points. An intra cluster correlation of 0.05 for patient outcomes was used (Murphey et al), and an average cluster size: 3 patients/practice resulted in compensatory increase to 110 patients per arm. Under the assumption that attrition would be 33 % we needed 166 patients per arm.||||.047
74076238|NCT01975948|147706310|OTHER|||||||0.15|||||||Mixed Models Analysis|||Our calculations indicated that 50 physicians in each of the two groups will provide \>80% power to detect clinically significant reductions in stigma as assessed by OMS-HC change scores. Clinically meaningful was defined as a change of 3 points, derived on the basis of this being slightly better than what is usually seen in brief interventions.||||0.15
74076239|NCT01975948|147706310|OTHER||Cohen'd|0.45||||0.03|TWO_SIDED|||||OMS-HC analysis adjusted for practice size: P value applies to between group physicians reduction in one stigma domaine: preference for social distance|Mixed Models Analysis|||Between Group Changes in subscale of the Opening Minds Scale for Health Care Providers (OMS-HC) measures three different dimensions of stigma: attitudes towards people with a mental illness (6 items); health care professionals' attitudes about disclosure of a mental illness/willingness to seek help for a mental illness (4 items), and preference for social distance (5 items). Items are rated on a 5-point scale. Mean scores can range from one to five with lower scores indicating less stigma.||||.03
74076240|NCT01975948|147706311|OTHER|||||||0.993|||||||Mixed Models Analysis|||||||.993
74076241|NCT01975948|147706312|OTHER||Cohen'd|1.48|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
74076242|NCT01975948|147706312|OTHER|||||||0.03|||||||Generalized estimating equations (GEE)|We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.||Correlation between increases in Physician Comfort and Confidence in managing mental illness and Stigma Score.||||.03
74076243|NCT01975948|147706313|OTHER||Cohen'd|1.44|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
74076244|NCT01975948|147706313|SUPERIORITY|||||||0.476||||||We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with non-program specific tools and Stigma Score.||||.476
74076245|NCT01975948|147706314|SUPERIORITY||Cohen'd|3.25|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
74076246|NCT01975948|147706314|SUPERIORITY|||||||0.945||||||We used the Spearman's correlation coefficient using the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with program specific tools and Stigma Score.||||.945
74076247|NCT01975948|147706315|OTHER|||||||0.742|||||||Mixed Models Analysis|||||||.742
74076248|NCT01975948|147706316|OTHER|||||||0.543|||||||Mixed Models Analysis|||||||.543
74076249|NCT01975948|147706317|OTHER|||||||0.009|||||||Mixed Models Analysis|||||||.009
74076250|NCT01975948|147706318|OTHER|||||||0.213|||||||Mixed Models Analysis|||||||.213
74076251|NCT02834663|147706324|SUPERIORITY||Mean Difference (Final Values)|-8.76|STANDARD_DEVIATION|12.521|<|0.0001|TWO_SIDED|95.0|-13.928|-3.592||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||Patients were evaluated for changes in BCVA of the treated eye, from the start of the study till 6 months, until trial completion. After administration of each injection, measurements of BCVA were compared to their respective baseline results. The paired t-test and repeated measures ANOVA was performed for comparative analysis, as all showed normality.||-3.592|-13.928|<0.0001
74076252|NCT02834663|147706325|SUPERIORITY||Mean Difference (Final Values)|110.0|STANDARD_DEVIATION|65.919||0.0001|TWO_SIDED|95.0|82.79|137.21||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||137.210|82.790|0.0001
74076253|NCT02834663|147706326|SUPERIORITY||Mean Difference (Final Values)|3.92|STANDARD_DEVIATION|4.932||0.001|TWO_SIDED|95.0|1.884|5.956||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||5.956|1.884|0.001
74076254|NCT02834663|147706327|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|2.24||0.0001|TWO_SIDED|95.0|1.3|3.15||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||3.15|1.30|0.0001
74076255|NCT02834663|147706328|SUPERIORITY||Mean Difference (Final Values)|5.64|STANDARD_DEVIATION|7.21||0.0001|TWO_SIDED|95.0|2.67|8.62||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||8.62|2.67|0.0001
73885023|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.12|TWO_SIDED|95.0|-1.27|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.15|-1.27|0.120
74076256|NCT02834663|147706329|SUPERIORITY||Mean Difference (Final Values)|5.64|STANDARD_DEVIATION|7.21||0.0001|TWO_SIDED|95.0|2.67|8.62||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||8.62|2.67|0.0001
74076257|NCT02834663|147706330|SUPERIORITY||Mean Difference (Final Values)|0.021|STANDARD_DEVIATION|1.87||0.221|TWO_SIDED|95.0|-0.751|0.795||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||0.795|-0.751|0.221
74076258|NCT03965091|147706332|OTHER||Least square (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7963|TWO_SIDED|95.0|-0.46|0.6|||Mixed Models Analysis|||Analysis was performed using a Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average PI-NRS score over the past 24 hours at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 as the dependent variable, sex, age group at FM onset, week, treatment, and treatment-by-week interaction as fixed factors, and baseline average of the daily average PI-NRS score as a covariate.||0.60|-0.46|0.7963
74076259|NCT03965091|147706332|OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.8629|TWO_SIDED|95.0|-0.48|0.58|||Mixed Models Analysis|||Analysis was performed using an MMRM model with change from baseline in the weekly average of the daily average PI-NRS score over the past 24 hours at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 as the dependent variable, sex, age group at FM onset, week, treatment, and treatment-by-week interaction as fixed factors, and baseline average of the daily average PI-NRS score as a covariate.||0.58|-0.48|0.8629
74076260|NCT02576938|147706352|SUPERIORITY||||||=|0.065|||||||Chi-squared|||||||=0.065
74076261|NCT02576938|147706352|SUPERIORITY||||||=|0.027|||||||Chi-squared|||||||=0.027
74076262|NCT00982397|147706364|SUPERIORITY_OR_OTHER||percentage of participants|98.5|||||TWO_SIDED|95.0|97.9|99.0|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|The study was designed to include at least 1,131 patients with DR/CRT-D ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with 1% precision.||99.0|97.9|
74076263|NCT00982397|147706364|SUPERIORITY_OR_OTHER||percentage of participants|97.5|||||TWO_SIDED|95.0|96.1|98.5|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|This study was designed to include at least 610 patients with VR-ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with a precision of 2%.||98.5|96.1|
74076264|NCT00982397|147706365|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is for comparison against a performance criterion of 10%.|Exact Binomial|||Using the one-sided one proportion Exact Test in PASS sample size software, a sample size of 76 subjects with 1-month follow-up was calculated to be required for the evaluation of this objective. To ensure adequate testing of the Protecta XT CRT-D device, the 76 subjects must have included at least 34 CRT-D subjects. Assuming an attrition rate of 10%, a sample size of 85 subjects enrolled was calculated to be required.||||<0.0001
74076265|NCT00982397|147706366|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is for comparison of the observed proportion of successes against a protocol-specified performance criterion of 95%.|Confidence interval and hypothesis test|||P, the expected proportion of successes under the null hypothesis, was 95%. α, the Type I error rate, is 0.025. Power is 90%. Pa, the assumed true proportion of successes, is 99%. Based on the above assumptions, at least 173 subjects with a useable time to VF detection testing were required for this objective. Assuming a 5% rate for the potential non-adherence to the testing protocol, the required enrollment sample size was 183.||||<0.0001
74076266|NCT00982397|147706367|NON_INFERIORITY_OR_EQUIVALENCE|Ho: p1 ≤ p2 - 0.05 Ha: p1 \> p2 - 0.05 Where p1 was the syncopal event free rate at one year post implant by programming VF NID 30/40 and p2 for NID = 18/24. If the null-hypothesis was rejected it was concluded that NID = 30/40 did not decrease the syncope free rate by more than 5% compared to NID = 18/24 and hence was non-inferior.|Risk Difference (RD)|0.0||||0.0013|TWO_SIDED|90.0|-2.7|2.7||P-Value is for non-inferiority|Farrington-Manning||The 90% Confidence Interval is for the difference (p1-p2), where p1=syncope free rate 30/40 arm and p2=syncope free rate 18/24 arm. Estimated value and confidence interval reflect percentages.|The expected syncopal event free rate was 0.984 in both programming groups. alpha, Type I error was 0.05. Power, 1-beta, was 80%. Non-inferiority margin 5% Based on the above assumptions and Farrington-Manning test, a total of 230 subjects was required. By further assuming 15% attrition rate and 5 % of crossover rate, a total of 300 subjects were needed.||2.7|-2.7|0.0013
74076267|NCT02363803|147706371|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Paired t-test||||||0.03
74076268|NCT03226522|147706398|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
74076269|NCT03226522|147706398|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
74076270|NCT00984126|147706399|SUPERIORITY_OR_OTHER||Incidence rate|0.0|||||ONE_SIDED|95.0||1.4||||||A one-sided 95% upper confidence limit was based on an exact calculation for a binomial distribution.||1.4||
74076271|NCT01001208|147706403|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||<0.0001
74076272|NCT01001208|147706404|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
73885024|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.119|TWO_SIDED|95.0|-1.29|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.15|-1.29|0.119
74076273|NCT01001208|147706405|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
74076274|NCT01001208|147706406|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
74076275|NCT01001208|147706407|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
74076276|NCT01001208|147706408|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
74076277|NCT01001208|147706409|SUPERIORITY_OR_OTHER|||||||0.0348||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0348
74076278|NCT01001208|147706410|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
74076279|NCT01001208|147706411|SUPERIORITY_OR_OTHER|||||||0.1995||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.1995
74076280|NCT01001208|147706412|SUPERIORITY_OR_OTHER|||||||0.1995||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.1995
74076281|NCT01864174|147706413|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study provided 90% power to demonstrate noninferiority in change from baseline mean HbA1c at Week 24, with an assumed standard deviation (SD) of 1.0%, a non-inferiority margin of 0.3%, and 2-sided alpha of 0.05 for the primary comparison|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.0687|||TWO_SIDED|95.0|-0.1|0.17|||||METFORMIN XR VS METFORMIN IR|||0.17|-0.10|
74076282|NCT01639222|147706426|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|179.72|||||TWO_SIDED|95.0|157.16|205.52|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D/reference treatment) are provided on the original scale as a ratio \* 100%.|The primary parameters were analysed in a mixed effects general linear model of the logtransformed values, including treatment as a fixed effect and subject as a random effect. The objective of the trial was met if the treatment contrast was statistically significantly different from 0 in the appropriate direction in a 2-sided test on a 5% significance level for both parameters. The 5% significance level for both primary parameters was not adjusted for multiple testing.||205.52|157.16|
74076283|NCT01639222|147706427|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|71.77|||||TWO_SIDED|95.0|68.83|74.84|||||Point estimate and 95% CI for the treatment difference ratio (Calcium-Vitamin D /reference treatment) are provided on the original scale as a ratio \* 100%.|||74.84|68.83|
74076284|NCT01639222|147706428|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|156.74|||||TWO_SIDED|95.0|121.66|201.93|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D / reference treatment) are provided on the original scale as a ratio \* 100%.|||201.93|121.66|
74076285|NCT01723397|147706436|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon signed-rank test|||||||0.8
74076286|NCT02009163|147706470|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value based on a log-rank test, stratified by 4-week cessation status (Yes, No). 4-week cessation was defined as a subject having no binge days during the 4 weeks prior to randomization.|Log Rank|||||||<0.001
74076287|NCT02009163|147706471|SUPERIORITY_OR_OTHER_LEGACY||difference in LS mean|-0.61|||<|0.001|TWO_SIDED|95.0|-0.81|-0.42||Nominal P-value not adjusted for multiplicity.|mixed- effects model for repeated measur|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.||||-0.42|-0.81|<0.001
74076288|NCT02009163|147706472|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Unadjusted P-value for the difference in distribution between treatment groups in CGI-S.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with a modified ridit score, adjusting for Visit 8 (Week 12) CGI-S as the covariate.||||||<0.001
74076289|NCT02009163|147706473|SUPERIORITY_OR_OTHER_LEGACY||difference in LS mean|-5.6|||<|0.001|TWO_SIDED|95.0|-7.2|-3.9||Nominal P-value not adjusted for multiplicity.|mixed-effects model for repeated measure|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.||||-3.9|-7.2|<0.001
74076290|NCT03117296|147706488|OTHER||Rank-Sum|0.05|||<|0.01|TWO_SIDED||||||Fisher Exact|||Univariate 2-group comparisons were performed using χ2 and Fisher's exact tests (when expected cell counts are \<5) for categorical variables, using 2-group t tests and Wilcoxon rank-sum tests (when normality distributions were violated) for continuous variables. Statistical significance was set at P \< .05. All analyses were performed using SAS 9.4 (SAS Institute, Cary, North Carolina).||||<0.01
74076291|NCT00833586|147706497|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|95.1||||||90.0|85.8|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.4|85.8|
74076292|NCT00833586|147706498|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.9||||||90.0|82.7|118.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||118.4|82.7|
74076293|NCT00833586|147706499|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|102.4||||||90.0|95.0|110.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.5|95.0|
74076294|NCT01304641|147706504|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
74076295|NCT01304641|147706505|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.078||||0.14|TWO_SIDED|95.0|0.976|1.192|||Regression, Cox|||||1.192|0.976|0.140
74076296|NCT01304641|147706506|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
74076297|NCT01304641|147706507|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
74076298|NCT01304641|147706508|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
74076299|NCT01304641|147706509|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
74076300|NCT01304641|147706510|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
74076301|NCT00465270|147706511|OTHER||Cox Proportional Hazard|0.49||||0.08|TWO_SIDED|95.0|0.22|1.11|||Log Rank|||||1.11|0.22|0.08
74076302|NCT00465270|147706513|OTHER||Cox Proportional Hazard|0.55||||0.046|TWO_SIDED|95.0|0.31|0.999|||Log Rank|||||0.999|0.31|0.046
73888366|NCT03594110|147309579|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.72||||0.0017|TWO_SIDED|95.0|0.59|0.89|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence cardiovascular death or end stage kidney disease (ESKD). HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.89|0.59|0.0017
74076303|NCT02444715|147706538|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.96
74076304|NCT02444715|147706538|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.03
74076305|NCT02444715|147706539|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.53
74076306|NCT02444715|147706539|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.44
74076307|NCT02444715|147706540|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.76
74076308|NCT02444715|147706540|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
74076309|NCT02444715|147706541|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.39
74076310|NCT02444715|147706541|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
74076311|NCT02444715|147706542|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.92
74076312|NCT02444715|147706542|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.37
74076313|NCT02444715|147706543|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.78
74076314|NCT02444715|147706543|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.19
74076315|NCT02444715|147706544|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.9
74076316|NCT02444715|147706544|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.43
74076317|NCT02444715|147706545|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.67
74076318|NCT02444715|147706545|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
74076319|NCT02444715|147706546|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.26
74076320|NCT02444715|147706546|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.07
74076321|NCT02444715|147706547|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.06
74076322|NCT02444715|147706547|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
74076323|NCT02444715|147706548|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"||||0.37
74076324|NCT02444715|147706548|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"||||0.34
74076325|NCT02444715|147706548|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"||||0.37
74076326|NCT02444715|147706548|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"||||0.59
74076327|NCT02444715|147706549|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.64
74076328|NCT02444715|147706549|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.14
74076329|NCT00017953|147706551|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.51|TWO_SIDED|95.0|0.83|1.09|||Regression, Cox|||||1.09|0.83|0.51
74076330|NCT00017953|147706552|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.42|TWO_SIDED|95.0|0.79|1.1|||Regression, Cox|||||1.10|0.79|0.42
74076331|NCT00017953|147706553|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.23|TWO_SIDED|95.0|0.82|1.05|||Regression, Cox|||||1.05|0.82|0.23
74076332|NCT00017953|147706554|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.29|TWO_SIDED|95.0|0.84|1.05|||Regression, Cox|||||1.05|0.84|0.29
74076333|NCT02374853|147706555|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
74076334|NCT02374853|147706556|SUPERIORITY|||||||0.25|||||||Fisher Exact|||||||0.25
74076335|NCT02374853|147706557|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||.054
74076336|NCT02305758|147706582|SUPERIORITY||Hazard Ratio (HR)|0.939|||||TWO_SIDED|95.0|0.596|1.48||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).||1.480|0.596|
74076337|NCT02305758|147706583|SUPERIORITY||Hazard Ratio (HR)|1.261|||||TWO_SIDED|95.0|0.738|2.156||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).||2.156|0.738|
74076338|NCT02305758|147706584|SUPERIORITY||Difference in proportions|-4.62|||||TWO_SIDED|95.0|-21.4|12.1|||Mantel Haenszel|||Comparisons between treatment groups were performed using the Mantel-Haenszel method, stratified by planned bevacizumab use (planned use versus no planned use).||12.1|-21.4|
74076339|NCT01379664|147706585|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|1.06||||0.24|TWO_SIDED|95.0|0.97|1.16|||Wilcoxon (Mann-Whitney)|||||1.16|0.97|0.24
74076340|NCT01379664|147706586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.87|TWO_SIDED|95.0|-0.23|0.19|||Generalized estimating equation model|Generalized estimating equation model weighted by inverse propensity score||||0.19|-0.23|0.87
74076341|NCT01379664|147706587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.74|TWO_SIDED|95.0|-4.7|3.3|||Generalized estimating equation model|Generalized estimating equation model weighted by propensity score||||3.3|-4.7|0.74
74076342|NCT01077596|147706613|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.3||||||||1.3|1.1|
74076343|NCT01077596|147706613|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
74076344|NCT01077596|147706613|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.3||||||||1.3|1.1|
74076345|NCT01077596|147706613|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
74076346|NCT01077596|147706613|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.0|1.3||||||||1.3|1.0|
74076347|NCT01077596|147706613|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
74076348|NCT01077596|147706613|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.4||||||||1.4|1.1|
74076349|NCT01077596|147706613|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|1.0|
74076350|NCT01077596|147706614|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.4||||||95.0|0.9|2.2||||||||2.2|0.9|
74076351|NCT01077596|147706614|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|0.8|2.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||2.0|0.8|
74076352|NCT01077596|147706614|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|0.8|2.0||||||||2.0|0.8|
74076353|NCT01077596|147706614|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.9|0.7|
74076354|NCT01077596|147706614|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.3||||||95.0|0.8|2.1||||||||2.1|0.8|
74076355|NCT01077596|147706614|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.9|0.7|
74076356|NCT01077596|147706614|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.2||||||95.0|1.2|3.9||||||||3.9|1.2|
74076357|NCT01077596|147706614|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.0||||||95.0|1.1|3.6|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.6|1.1|
74076358|NCT01077596|147706615|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.5||||||95.0|3.2|6.3||||||||6.3|3.2|
74076359|NCT01077596|147706615|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.0||||||95.0|2.0|4.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.4|2.0|
74076360|NCT01077596|147706615|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.0||||||95.0|2.8|5.8||||||||5.8|2.8|
74076361|NCT01077596|147706615|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.9||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.5|1.9|
74076362|NCT01077596|147706615|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.4||||||95.0|3.1|6.3||||||||6.3|3.1|
74076363|NCT01077596|147706615|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.0||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.5|1.9|
74076364|NCT01077596|147706615|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.5||||||95.0|2.8|7.2||||||||7.2|2.8|
74076365|NCT01077596|147706615|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.5||||||95.0|2.1|5.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||5.9|2.1|
74076366|NCT01077596|147706616|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.6||||||95.0|1.7|4.1||||||||4.1|1.7|
74076367|NCT01077596|147706616|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.1||||||95.0|1.3|3.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.4|1.3|
74076368|NCT01077596|147706616|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.3||||||95.0|1.4|3.6||||||||3.6|1.4|
73885025|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.976|TWO_SIDED|95.0|-0.71|0.69||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.69|-0.71|0.976
73885026|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17||||0.026|TWO_SIDED|95.0|0.14|2.2||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||2.20|0.14|0.026
73885027|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.497|TWO_SIDED|95.0|-0.69|1.42||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||1.42|-0.69|0.497
73885028|NCT00385671|147303872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.112|TWO_SIDED|95.0|-1.8|0.19||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.19|-1.80|0.112
73885029|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.486||95.0||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.486
73885030|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.983
73885031|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||p-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.411
73885032|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.554||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.554
73888536|NCT01409707|147309678|SUPERIORITY_OR_OTHER||||||=|0.39||95.0||||The a priori threshold for statistical significance was set at p=.05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there would be no differences in alcohol use at posttreatment.||||= 0.39
73885033|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.128
73885034|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.488||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.488
73885035|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.226
73885036|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.710
73885037|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.133
73885038|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.257
73885039|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.412||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.412
73885040|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.030
73885041|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.024
74076369|NCT01077596|147706616|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.0|1.1|
74076370|NCT01077596|147706616|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.3||||||95.0|1.5|3.7||||||||3.7|1.5|
73885042|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.250
73888537|NCT01929317|147309694|SUPERIORITY_OR_OTHER||Mean change from Baseline|-4.8|||<|0.001|TWO_SIDED|95.0|-6.3|-3.2|||t-test, 1 sided|||||-3.2|-6.3|<0.001
74076371|NCT01077596|147706616|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.0|1.1|
74076372|NCT01077596|147706616|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.6||||||95.0|1.5|4.5||||||||4.5|1.5|
74076373|NCT01077596|147706616|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.2||||||95.0|1.3|3.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.9|1.3|
74076374|NCT01077596|147706617|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.8||||||95.0|0.5|1.3||||||||1.3|0.5|
74076375|NCT01077596|147706617|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.7||||||95.0|0.4|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.4|
74076376|NCT01077596|147706617|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.6||||||95.0|0.4|1.1||||||||1.1|0.4|
74076377|NCT01077596|147706617|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.6||||||95.0|0.3|1.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.0|0.3|
74076378|NCT01077596|147706617|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.8||||||95.0|0.5|1.4||||||||1.4|0.5|
74076379|NCT01077596|147706617|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.8||||||95.0|0.4|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.4|0.4|
74076380|NCT01077596|147706617|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.6|2.0||||||||2.0|0.6|
74076381|NCT01077596|147706617|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.6|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status†, previous depression dx, previous IBD‡ diagnosis, OC§ use, HRT/ERT use, and NSAID use.|||1.9|0.6|
74076382|NCT01077596|147706618|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.9||||||95.0|0.8|1.1||||||||1.1|0.8|
74076383|NCT01077596|147706618|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
74076384|NCT01077596|147706618|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.9|1.2||||||||1.2|0.9|
74076385|NCT01077596|147706618|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
74076386|NCT01077596|147706618|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.8|1.1||||||||1.1|0.8|
74076387|NCT01077596|147706618|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
74076388|NCT01077596|147706618|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.9|1.3||||||||1.3|0.9|
74076389|NCT01077596|147706618|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.9|
74076390|NCT01077596|147706619|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|1.0|1.3||||||||1.3|1.0|
74076391|NCT01077596|147706619|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|1.0|
74076392|NCT01077596|147706619|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.0|1.4||||||||1.4|1.0|
74076393|NCT01077596|147706619|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.4|1.0|
74076394|NCT01077596|147706619|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.9|1.2||||||||1.2|0.9|
74076395|NCT01077596|147706619|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|0.9|
74076396|NCT01077596|147706619|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.9|1.2||||||||1.2|0.9|
74076397|NCT01077596|147706619|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.8|
74076398|NCT03616106|147706620|OTHER||Slope|-15.103||||0.859|TWO_SIDED|95.0|-184.574|154.369||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||154.369|-184.574|0.859
74076399|NCT03616106|147706621|OTHER||Slope|28.243||||0.213|TWO_SIDED|95.0|-16.694|73.179||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||73.179|-16.694|0.213
74076400|NCT03616106|147706622|OTHER||Slope|58.993||||0.031|TWO_SIDED|95.0|5.713|112.274||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||112.274|5.713|0.031
74076401|NCT03616106|147706623|OTHER||Slope|-0.0651||||0.053|TWO_SIDED|95.0|-1.313|0.01||The p-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||Viral load variables were log transformed for regression analyses.||0.010|-1.313|0.053
73885043|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.489
74076402|NCT03616106|147706624|OTHER||Slope|-1.601||||0.008|TWO_SIDED|95.0|-2.761|-0.442||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||-0.442|-2.761|0.008
74076403|NCT03616106|147706625|OTHER||Slope|-2.674||||0|TWO_SIDED|95.0|-3.934|-1.415||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||-1.415|-3.934|0.000
74076404|NCT03616106|147706639|OTHER||Slope|2.172||||0|TWO_SIDED|95.0|1.448|2.895||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||2.895|1.448|0.000
74076405|NCT03616106|147706640|OTHER||Slope|2.872||||0|TWO_SIDED|95.0|2.1|3.643||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||3.643|2.100|0.000
74076406|NCT03616106|147706641|OTHER||Slope|3.166||||0|TWO_SIDED|95.0|2.487|3.846||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||3.846|2.487|0.000
74076407|NCT03616106|147706642|OTHER||Z Score|3.25||||0.0011|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.0011
74076408|NCT03616106|147706643|OTHER||Z score|3.94||||0.0001|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.0001
74076409|NCT03616106|147706644|OTHER||Z score|4.12||||0|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.000
74076410|NCT03616106|147706645|OTHER||Slope|1.935||||0|TWO_SIDED|95.0|1.055|2.815||This p-value was not adjusted for multiple comparisons. The p-value threshold for statistical significance was, therefore, 0.05|Regression, Linear|||||2.815|1.055|0.000
74076411|NCT03616106|147706646|OTHER||Slope|2.123||||0|TWO_SIDED|95.0|1.184|3.062||The p-value was not adjusted for multiple comparison, therefore, the threshold for statistical significance was 0.05.|Regression, Linear|||||3.062|1.184|0.000
74076412|NCT03616106|147706647|OTHER||Slope|2.552||||0|TWO_SIDED|95.0|1.612|3.492||The p-value was not adjusted for multiple comparison, therefore, the threshold for statistical significance was 0.05.|Regression, Linear|||||3.492|1.612|0.000
74076413|NCT03616106|147706648|OTHER||Z score|-1.57||||0.1167|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.1167
74076414|NCT03616106|147706649|OTHER||Z score|-2.91||||0.0036|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.0036
74076415|NCT03616106|147706650|OTHER||Z score|-3.54||||0.0004|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.0004
74076416|NCT03880266|147706673|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.244|TWO_SIDED|95.0|-3.76|0.6|||Wilcoxon (Mann-Whitney)|||||0.60|-3.76|0.244
74076417|NCT03880266|147706673|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.168|TWO_SIDED|95.0|-0.65|3.43|||Wilcoxon (Mann-Whitney)|||||3.43|-0.65|0.168
74076418|NCT03880266|147706673|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.699|TWO_SIDED|95.0|-2.39|1.72|||Wilcoxon (Mann-Whitney)|||||1.72|-2.39|0.699
74076419|NCT03880266|147706673|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.833|TWO_SIDED|95.0|-1.94|2.02|||Wilcoxon (Mann-Whitney)|||||2.02|-1.94|0.833
74076420|NCT03880266|147706674|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
74076421|NCT03880266|147706674|SUPERIORITY|||||||0.589|||||||Fisher Exact|||||||0.589
74076422|NCT03880266|147706674|SUPERIORITY|||||||0.154|||||||Fisher Exact|||||||0.154
74076423|NCT03880266|147706674|SUPERIORITY|||||||0.646|||||||Fisher Exact|||||||0.646
74076424|NCT03880266|147706675|SUPERIORITY||Mean Difference (Final Values)|-206.5||||0.093|TWO_SIDED|95.0|-451.9|38.9|||t-test, 2 sided|||||38.9|-451.9|0.093
74076425|NCT03880266|147706675|SUPERIORITY||Mean Difference (Final Values)|144.1||||0.186|TWO_SIDED|95.0|-78.6|366.7|||t-test, 2 sided|||||366.7|-78.6|0.186
74076426|NCT03880266|147706675|SUPERIORITY||Mean Difference (Final Values)|-151.7||||0.058|TWO_SIDED|95.0|-309.0|5.7|||t-test, 2 sided|||||5.7|-309.0|0.058
74076427|NCT03880266|147706675|SUPERIORITY||Mean Difference (Final Values)|160.6||||0.186|TWO_SIDED|95.0|-611.2|290.1|||t-test, 2 sided|||||290.1|-611.2|0.186
74076428|NCT03880266|147706676|SUPERIORITY||Mean Difference (Final Values)|-33.62||||0.13|TWO_SIDED|95.0|-78.42|11.17|||t-test, 2 sided|||||11.17|-78.42|0.130
74076429|NCT03880266|147706676|SUPERIORITY||Mean Difference (Final Values)|24.26||||0.518|TWO_SIDED|95.0|-54.62|103.13|||t-test, 2 sided|||||103.13|-54.62|0.518
74076430|NCT03880266|147706676|SUPERIORITY||Mean Difference (Final Values)|-38.14||||0.061|TWO_SIDED|95.0|-78.32|2.03|||t-test, 2 sided|||||2.03|-78.32|0.061
74076431|NCT03880266|147706676|SUPERIORITY||Mean Difference (Final Values)|-39.34||||0.366|TWO_SIDED|95.0|-128.4|49.72|||t-test, 2 sided|||||49.72|-128.40|0.366
73885044|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.682||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.682
73885045|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.953
73885046|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.803||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.803
73885047|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.694||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.694
73885048|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.835||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.835
73885049|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.435
73885050|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.379
73885051|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.247
73888538|NCT01929317|147309695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 2.|||2.0|-2.4|
74076432|NCT03880266|147706677|SUPERIORITY|||||||0.515|||||||Fisher Exact|||||||0.515
74076433|NCT03880266|147706677|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.560
74076434|NCT03880266|147706677|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
74076435|NCT03880266|147706677|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.290
74076436|NCT03161405|147706678|OTHER||Geometric mean ratio|1.9827|||||TWO_SIDED|90.0|1.6446|2.3904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90 percent (%) confidence interval (CI) for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||2.3904|1.6446|
74076437|NCT03161405|147706679|OTHER||Geometric mean ratio|1.2914|||||TWO_SIDED|90.0|1.1199|1.4891||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.4891|1.1199|
74076438|NCT03161405|147706680|OTHER||Geometric mean ratio|1.2783|||||TWO_SIDED|90.0|1.0965|1.4904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.4904|1.0965|
74076439|NCT04189848|147706699|OTHER|Treatment comparison|Treatment difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-8.2|-3.6|||ANOVA|||Intensity of injection site pain was analysed by a fixed analysis of variance model with VAS pain score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||-3.6|-8.2|<0.0001
73888539|NCT01929317|147309695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.9|3.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 4.|||3.1|-1.9|
74076440|NCT05472038|147706720|SUPERIORITY|Superiority based on GMR was declared if the lower limit of the 2-sided 95% CI for the GMR was greater than 1.|Model-Based GMR|2.91|||||TWO_SIDED|95.0|2.45|3.44||||||||3.44|2.45|
74076441|NCT05472038|147706721|NON_INFERIORITY|Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is \>-5%.|Adjusted Difference in Percentages|26.77|||||TWO_SIDED|95.0|19.59|33.95|||||Adjusted difference and 2-Sided CI based on the Miettinen and Nurminen method stratified by baseline NT category (\< median,\>= median) for difference in proportions. The median of baseline NT was calculated based on pooled data in 2 comparator groups.|||33.95|19.59|
74076442|NCT05472038|147706722|NON_INFERIORITY|Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was \>=0.8.|Model-Based GMR|0.98|||||TWO_SIDED|95.0|0.83|1.16|||||GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.|||1.16|0.83|
74076443|NCT05472038|147706723|NON_INFERIORITY|Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is \>-10%.|Adjusted Difference in Percentages|-3.03|||||TWO_SIDED|95.0|-9.68|3.63|||||2-Sided CI based on Miettinen and Nurminen method stratified by baseline NT category(\< median,\>= median)for difference in percentage(seroresponse rate).Median of baseline neutralizing titers was calculated based on pooled data in 2 comparator groups.|||3.63|-9.68|
74076444|NCT05472038|147706728|NON_INFERIORITY|Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was \>=0.8.|Model-Based GMR|1.38|||||TWO_SIDED|95.0|1.22|1.56|||||GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.|||1.56|1.22|
74076445|NCT02847650|147706752|OTHER||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|2.26||0.0407|TWO_SIDED|90.0|-8.6|-1.0|||Mixed Models Analysis|||||-1.0|-8.6|0.0407
74076446|NCT00834249|147706768|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
74076447|NCT00834249|147706769|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
73885052|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.784
73885053|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||p-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.696
74076448|NCT00834249|147706770|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.71||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
74076449|NCT00834249|147706771|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|109.61||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||||
74076450|NCT00834249|147706772|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.85||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational puposes only.|||||
74076451|NCT00834249|147706773|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.38||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||||
74076452|NCT00834067|147706795|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.7||||||90.0|90.1|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|90.1|
74076453|NCT00834067|147706796|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.9|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108|99.9|
74076454|NCT00834067|147706797|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|99.7|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107|99.7|
74076455|NCT00834067|147706798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|96.0|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|96|
74076456|NCT00834067|147706799|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.1|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|99.1|
73885054|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.725
73885055|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.899
73885056|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.782||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.782
74076457|NCT00834067|147706800|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.4|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|99.4|
74076458|NCT00834067|147706801|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|99.8|114.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||114|99.8|
74076459|NCT00834067|147706802|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|99.0|106.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106|99|
74076460|NCT00834067|147706803|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|98.1|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||108|98.1|
74076461|NCT02718326|147706808|SUPERIORITY||percentage difference|52.3|||<|0.0001|TWO_SIDED|95.0|45.2|59.5|||Cochran-Mantel-Haenszel|||||59.5|45.2|<0.0001
74076462|NCT02718326|147706809|SUPERIORITY||percentage difference|50.1|||<|0.0001|TWO_SIDED|95.0|40.1|60.1|||Cochran-Mantel-Haenszel|||||60.1|40.1|<0.0001
74076463|NCT02718326|147706809|SUPERIORITY||percentage difference|64.8|||<|0.0001|TWO_SIDED|95.0|55.8|73.9|||Cochran-Mantel-Haenszel|||||73.9|55.8|< 0.0001
73885057|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.307
73885058|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.457
74076464|NCT02718326|147706810|SUPERIORITY||percentage difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-24.7|-9.9|||Cochran-Mantel-Haenszel|||||-9.9|-24.7|<0.0001
74076465|NCT02718326|147706810|SUPERIORITY||percentage difference|-16.6|||<|0.0001|TWO_SIDED|95.0|-24.2|-9.1|||Cochran-Mantel-Haenszel|||||-9.1|-24.2|<0.0001
74076466|NCT02718326|147706811|SUPERIORITY||percentage difference|-17.3|||=|0.0002|TWO_SIDED|95.0|-26.2|-8.5|||Cochran-Mantel-Haenszel|||||-8.5|-26.2|= 0.0002
74076467|NCT02718326|147706811|SUPERIORITY||percentage difference|-18.9|||<|0.0001|TWO_SIDED|95.0|-27.5|-10.4|||Cochran-Mantel-Haenszel|||||-10.4|-27.5|<0.0001
74076468|NCT02718326|147706814|SUPERIORITY||percentage difference|-6.0||||0.0096|TWO_SIDED|95.0|-10.5|-1.5|||Cochran-Mantel-Haenszel|||||-1.5|-10.5|0.0096
74076469|NCT02718326|147706814|SUPERIORITY||percentage difference|-6.0||||0.0089|TWO_SIDED|95.0|-10.5|-1.6|||Cochran-Mantel-Haenszel|||||-1.6|-10.5|0.0089
74076470|NCT02718326|147706815|SUPERIORITY||Estimate for contrast|0.8||||0.0529|TWO_SIDED|95.0|-0.01|1.6|||ANOVA|||||1.60|-0.01|0.0529
74076471|NCT02718326|147706815|SUPERIORITY||Estimate for contrast|1.14||||0.0057|TWO_SIDED|95.0|0.33|1.94|||ANOVA|||||1.94|0.33|0.0057
74076472|NCT05025345|147706816|NON_INFERIORITY|Noninferiority margin equals -0.1|Mean Difference (Final Values)|-0.013|||||TWO_SIDED|90.0|-0.036|0.011||Success criteria was evaluated using lower confidence interval. No P-Value was calculated.||||||0.011|-0.036|
74076473|NCT05025345|147706817|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
74076474|NCT02322593|147706827|SUPERIORITY||Hazard Ratio (HR)|0.83|STANDARD_ERROR_OF_MEAN|0.091||0.039|TWO_SIDED|95.0|0.69|0.99|||Log Rank|||||0.99|0.69|0.039
74076475|NCT02322593|147706828|SUPERIORITY||Hazard Ratio (HR)|0.79|STANDARD_ERROR_OF_MEAN|0.086||0.0045|TWO_SIDED|95.0|0.66|0.93|||Log Rank|||||0.93|0.66|0.0045
74076476|NCT02322593|147706829|SUPERIORITY||Hazard Ratio (HR)|0.82|STANDARD_ERROR_OF_MEAN|0.078||0.011|TWO_SIDED|95.0|0.7|0.96|||Log Rank|||||0.96|0.70|0.011
74076477|NCT02322593|147706830|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73885059|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.712||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.712
73885060|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.403||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.403
73885061|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.713||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.713
73885062|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.498
73885063|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.963
74076478|NCT02322593|147706831|SUPERIORITY|||||||0.092|||||||Fisher Exact|||||||0.092
74076479|NCT00834418|147706832|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|99.6|116.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||116|99.6|
74076480|NCT00834418|147706833|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|95.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109|95.2|
74076481|NCT01705574|147706834|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis was that the STB group was at least 12% worse than the ATV+RTV+TVD group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 (response rate as defined by the snapshot analysis algorithm). The alternative hypothesis was that the STB group was less than 12% worse than the ATV+RTV+TVD group.|Difference in proportions|6.5|||||TWO_SIDED|95.2|0.4|12.6|||||Difference in percentages of virologic success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel (MH) proportion.|||12.6|0.4|
74076482|NCT01705574|147706834|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|6.5||||0.034|TWO_SIDED|95.2|0.4|12.6|||Cochran-Mantel-Haenszel|P-value comparing virologic success was from the CMH test stratified by baseline HIV-1 RNA and race strata.|Difference in percentages of virologic success and its 95.2% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted MH proportion. If the lower bound of the CI was \> 0, superiority of STB over ATV+RTV+TVD was established.|If noninferiority of STB versus ATV+RTV+TVD was established, the same 95.2% CI used in evaluating noninferiority was used to evaluate superiority. The baseline HIV-1 RNA and race stratum-stratified, 2-sided CMH test was also used to assess superiority as a secondary assessment.||12.6|0.4|0.034
74076483|NCT00777023|147706839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.61|STANDARD_ERROR_OF_MEAN|0.53||0.0024|TWO_SIDED|97.5|-2.8|-0.42||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4||-0.42|-2.80|0.0024
74076484|NCT00777023|147706839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|0.52||0.004|TWO_SIDED|97.5|-2.69|-0.33||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4||-0.33|-2.69|0.0040
74076485|NCT00777023|147706840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|0.51||0.0024|TWO_SIDED|97.5|-2.72|-0.41||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12||-0.41|-2.72|0.0024
74076486|NCT00777023|147706840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.51||0.0281|TWO_SIDED|97.5|-2.26|0.02||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12||0.02|-2.26|0.0281
73885064|NCT00385671|147303873|SUPERIORITY_OR_OTHER|||||||0.338||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.338
73885065|NCT00385671|147303874|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.645
73885066|NCT00385671|147303874|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.248
74076487|NCT00777023|147706841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0608|TWO_SIDED|97.5|-0.32|-0.03||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4||-0.03|-0.32|0.0608
74076488|NCT00777023|147706841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.08||0.0003|TWO_SIDED|97.5|-0.45|-0.11||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4||-0.11|-0.45|0.0003
74076489|NCT00777023|147706842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.028|TWO_SIDED|97.5|-0.43|0.0||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12||0.00|-0.43|0.0280
74076490|NCT00777023|147706842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0026|TWO_SIDED|97.5|-0.51|-0.07||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12||-0.07|-0.51|0.0026
74076491|NCT02659150|147706845|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|0.24||0.26|TWO_SIDED||||||t-test, 2 sided|||Paired T-test comparing values obtained during the follow-up imaging (at 13-18 weeks)minus the baseline values||||0.26
74076492|NCT02659150|147706846|OTHER||Spearman Correlation Coefficient|0.76||||0.036|TWO_SIDED||||||Spearman|||correlation coefficient||||0.036
74076493|NCT02659150|147706847|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_DEVIATION|0.32||0.14|TWO_SIDED||||||t-test, 2 sided|||The carotid artery plaque with highest FDG uptake is located using Positron Emission Tomography/ Magnetic Resonance Imaging images. Thereafter Paired T- Test is used to compare baseline vs follow-up values of FDG uptake (before vs after 12 weeks of tocilizumab treatment). FDG uptake is assessed as a Target to background values (TBR) , which is calculated as the mean arterial standardized uptake value (SUV) divided by background blood pool SUV.||||0.14
74076494|NCT02659150|147706848|SUPERIORITY||correlation coefficient|-0.66||||0.076|TWO_SIDED||||||Spearman's Method|||||||0.076
74076495|NCT02659150|147706849|SUPERIORITY||Correlation coefficient|0.67||||0.07|TWO_SIDED||||||Spearman's Method|||||||0.07
74076496|NCT00089661|147706859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|||<|0.0001||95.0|4.8|6.3|||ANCOVA|||||6.3|4.8|<0.0001
74076497|NCT02647944|147706873|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74076498|NCT02647944|147706874|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
74076499|NCT02647944|147706875|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
74076500|NCT02647944|147706876|SUPERIORITY|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||||||0.069
74076501|NCT02647944|147706877|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||0.054
74076502|NCT02647944|147706878|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
74076503|NCT02647944|147706879|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
74076504|NCT02647944|147706880|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
73885067|NCT00385671|147303874|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.470
73885068|NCT00385671|147303874|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.914
73885069|NCT00385671|147303874|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.505
74076505|NCT02760368|147706887|SUPERIORITY||Risk Difference (RD)|0.378|||<|0.0001|TWO_SIDED|97.5|0.248|0.489|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rates for 64 q2w treatment group at Week 12 are expected to be at least 55%, resulting in an expected difference in ACR20 response rates of 30 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.||0.489|0.248|<0.0001
73885070|NCT00385671|147303874|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.570
73885071|NCT00385671|147303874|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.430
73885072|NCT00385671|147303874|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.090
73885073|NCT00385671|147303874|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.341
73885074|NCT00385671|147303875|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.130
73885075|NCT00385671|147303875|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.192
73885076|NCT00385671|147303875|SUPERIORITY_OR_OTHER|||||||0.936||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.936
73885077|NCT00385671|147303875|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.480
73888540|NCT01929317|147309695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-2.3|3.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 6.|||3.0|-2.3|
74076506|NCT02760368|147706887|SUPERIORITY||Risk Difference (RD)|0.445|||<|0.0001|TWO_SIDED|97.5|0.318|0.552|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rates for 64 q4w treatment group at Week 12 are expected to be at least 50%, resulting in an expected difference in ACR20 response rates of 25 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.||0.552|0.318|<0.0001
74076507|NCT02760368|147706888|SUPERIORITY||Risk Difference (RD)|0.294|||<|0.0001|TWO_SIDED|97.5|0.197|0.389|||Chi-squared|2x2 chi-square test||DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 30% in 64 q2w OKZ treatment groups respectively, resulting in an expected difference of 20 percentage points between OKZ q2w treatment group and placebo.||0.389|0.197|<0.0001
74076508|NCT02760368|147706888|SUPERIORITY||Risk Difference (RD)|0.352|||<|0.0001|TWO_SIDED|97.5|0.251|0.449|||Chi-squared|2x2 chi-square test||DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 22% in 64 mg q4w OKZ treatment group respectively, resulting in an expected difference of 12 percentage points between OKZ q4w treatment group and placebo.||0.449|0.251|<0.0001
74076509|NCT02760368|147706889|SUPERIORITY||Least Squares Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|97.5|-0.47|-0.21|||ANCOVA|||||-0.21|-0.47|<0.0001
74076510|NCT02760368|147706889|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|97.5|-0.49|-0.23|||ANCOVA|||||-0.23|-0.49|<0.0001
74076511|NCT02760368|147706890|SUPERIORITY||Risk Difference (RD)|0.35|||<|0.0001|TWO_SIDED|97.5|0.239|0.45|||Chi-squared|2x2 chi-square test||||0.450|0.239|<0.0001
74076512|NCT02760368|147706890|SUPERIORITY||Risk Difference (RD)|0.409|||<|0.0001|TWO_SIDED|97.5|0.296|0.509|||Chi-squared|2x2 chi-square test||||0.509|0.296|<0.0001
74076513|NCT02760368|147706891|SUPERIORITY||Risk Difference (RD)|0.084|||<|0.0002|TWO_SIDED|97.5|0.032|0.151||2x2 chi-square test|Chi-squared|||||0.151|0.032|<0.0002
74076514|NCT02760368|147706891|SUPERIORITY||Risk Difference (RD)|0.077|||<|0.0003|TWO_SIDED|97.5|0.027|0.143||2x2 chi-square test|Chi-squared|||||0.143|0.027|<0.0003
74076515|NCT01860521|147706911|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
74076516|NCT01860521|147706912|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.005
74076517|NCT01860521|147706913|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.047
74076518|NCT01860521|147706914|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.047
74076519|NCT00904215|147706955|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Student Paired t-test|||||||<0.0001
74076520|NCT00904215|147706956|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
74076521|NCT00904215|147706957|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
74076522|NCT00904215|147706958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
74076523|NCT01299454|147706968|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.166|||||TWO_SIDED|90.0|0.776|1.751|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.751|0.776|
74076524|NCT01299454|147706968|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.375|||||TWO_SIDED|90.0|0.915|2.066|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.066|0.915|
74076525|NCT01299454|147706968|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.929|||||TWO_SIDED|90.0|0.581|1.488|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.488|0.581|
74076526|NCT01299454|147706969|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.255|||||TWO_SIDED|90.0|0.702|2.244|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.244|0.702|
73885078|NCT00385671|147303875|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.690
73885079|NCT00385671|147303875|SUPERIORITY_OR_OTHER|||||||0.923||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.923
73885080|NCT00385671|147303875|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.202
73885081|NCT00385671|147303875|SUPERIORITY_OR_OTHER|||||||0.114||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.114
73885082|NCT00385671|147303875|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.954
73885083|NCT00385671|147303876|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P-value for Direct Treatment Effect. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for tests of direct and indirect effects.|Regression, Linear|||||||0.107
74076527|NCT01299454|147706969|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.727|||||TWO_SIDED|90.0|0.977|3.052|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||3.052|0.977|
73885084|NCT00385671|147303877|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.968
74076528|NCT01299454|147706969|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.041|||||TWO_SIDED|90.0|0.506|2.142|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||2.142|0.506|
73885085|NCT00385671|147303877|SUPERIORITY_OR_OTHER|||||||0.492||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.492
73885086|NCT00385671|147303877|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.463
73885087|NCT00385671|147303880|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.103
73885088|NCT00385671|147303880|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.167
73885089|NCT00385671|147303880|SUPERIORITY_OR_OTHER|||||||0.919||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.919
73885090|NCT00385671|147303883|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.008
73885091|NCT00385671|147303883|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.033
73885092|NCT00385671|147303883|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.688
73885093|NCT00385671|147303885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.365|TWO_SIDED|95.0|-0.33|0.9||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||0.90|-0.33|0.365
73885094|NCT00385671|147303885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.172|TWO_SIDED|95.0|-0.2|1.13||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||1.13|-0.20|0.172
73888367|NCT03594110|147309580|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression or CV death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.72|
74076529|NCT01299454|147706970|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.904|||||TWO_SIDED|90.0|0.707|1.156|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||1.156|0.707|
73888368|NCT03594110|147309581|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.72|
73888541|NCT01929317|147309695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-3.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 8.|||2.0|-3.4|
74076530|NCT01299454|147706970|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.665|1.087|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||1.087|0.665|
74076531|NCT01299454|147706970|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.531||||||90.0|0.399|0.705|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||0.705|0.399|
74076532|NCT01299454|147706971|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.103|||||TWO_SIDED|90.0|0.774|1.573|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.573|0.774|
74076533|NCT01299454|147706971|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.199|||||TWO_SIDED|90.0|0.841|1.71|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.710|0.841|
74076534|NCT01299454|147706971|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.524|1.189|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.189|0.524|
73888542|NCT01929317|147309695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-2.0|3.9|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 12.|||3.9|-2.0|
74076535|NCT01299454|147706972|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.241|||||TWO_SIDED|90.0|0.719|2.143|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.143|0.719|
74076536|NCT01299454|147706972|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance|Geometric Mean Ratio|1.604|||||TWO_SIDED|90.0|0.942|2.732|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.732|0.942|
74076537|NCT01299454|147706972|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.077|||||TWO_SIDED|90.0|0.54|2.146|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.146|0.540|
74076538|NCT01299454|147706973|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric mean ratio|0.856|||||TWO_SIDED|90.0|0.691|1.059|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.059|0.691|
74076539|NCT01299454|147706973|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.742|||||TWO_SIDED|90.0|0.599|0.918|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.918|0.599|
74076540|NCT01299454|147706973|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.451|||||TWO_SIDED|90.0|0.352|0.577|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.577|0.352|
74076541|NCT01299454|147706982|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.509|||||TWO_SIDED|90.0|0.346|0.748|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.748|0.346|
73888543|NCT01929317|147309697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 2.|||0.3|-0.2|
73885095|NCT00385671|147303885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.594|TWO_SIDED|95.0|-0.49|0.85||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||0.85|-0.49|0.594
73888544|NCT01929317|147309697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 4.|||0.4|-0.2|
74076542|NCT01299454|147706982|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.586|||||TWO_SIDED|90.0|0.399|0.861|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.861|0.399|
74076543|NCT01299454|147706982|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.334|||||TWO_SIDED|90.0|0.214|0.521|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.521|0.214|
74076544|NCT01299454|147706983|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.716|||||TWO_SIDED|90.0|0.445|1.153|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.153|0.445|
74076545|NCT01299454|147706983|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.594|||||TWO_SIDED|90.0|0.378|0.934|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.934|0.378|
74076546|NCT01299454|147706983|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.561|||||TWO_SIDED|90.0|0.308|1.022|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.022|0.308|
74076547|NCT01299454|147706984|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.558|||||TWO_SIDED|90.0|0.368|0.845|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.845|0.368|
74076548|NCT01299454|147706984|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.516|||||TWO_SIDED|90.0|0.341|0.781|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.781|0.341|
74076549|NCT01299454|147706984|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.314|||||TWO_SIDED|90.0|0.195|0.507|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.507|0.195|
74076550|NCT00838630|147706998|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed for the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.27||||||90.0|92.32|104.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.61|92.32|
74076551|NCT00838630|147706999|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed for log-transformed AUC0-t, AUC0-inf, and Cmax parameters.|Geometric Test/Ref Ratio x 100|94.37||||||90.0|90.47|98.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.43|90.47|
74076552|NCT00838630|147707000|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.7||||||90.0|91.52|100.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.08|91.52|
74076553|NCT03140631|147707009|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74076554|NCT03140631|147707010|SUPERIORITY|||||||0.74|||||||Fisher Exact|||number of participants who experienced a vascular access site complication at 90 days||||0.74
74076555|NCT00838279|147707067|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.31||||||90.0|97.82|102.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.85|97.82|
74076556|NCT00838279|147707068|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.78||||||90.0|99.09|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.55|99.09|
74076557|NCT00838279|147707069|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.94||||||90.0|97.4|102.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.55|97.40|
74076558|NCT00840411|147707090|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.0||||||90.0|93.3|107.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.1|93.3|
74076559|NCT00840411|147707091|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|86.5||||||90.0|80.1|93.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||93.4|80.1|
73888369|NCT03594110|147309582|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.72|0.9|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of death from any cause or ESKD. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.90|0.72|
74076560|NCT00840411|147707092|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|87.2||||||90.0|81.0|93.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||93.8|81.0|
74076561|NCT01985308|147707109|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
74076562|NCT01854047|147707134|SUPERIORITY||Least Square (LS) Mean Difference|0.21||||0.0063|TWO_SIDED|95.0|0.06|0.36||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using mixed effect model with repeated measures (MMRM) approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w, and 200 mg q4w.||0.36|0.06|0.0063
74076563|NCT01854047|147707134|SUPERIORITY||LS Mean Difference|0.26||||0.0008|TWO_SIDED|95.0|0.11|0.4||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w|||0.40|0.11|0.0008
74076564|NCT01854047|147707134|SUPERIORITY||LS Mean Difference|0.17||||0.0212|TWO_SIDED|95.0|0.03|0.32||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w|||0.32|0.03|0.0212
74076565|NCT01854047|147707134|SUPERIORITY||LS Mean Difference|0.08||||0.2774|TWO_SIDED|95.0|-0.07|0.23||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w|||0.23|-0.07|0.2774
74076566|NCT01854047|147707135|SUPERIORITY||LS Mean Difference|0.16||||0.0002|TWO_SIDED|95.0|0.08|0.25||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using MMRM approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w and 200 mg q4w.||0.25|0.08|0.0002
74076567|NCT01854047|147707135|SUPERIORITY||LS Mean Difference|0.2|||<|0.0001|TWO_SIDED|95.0|0.011|0.28||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w|||0.28|0.011|<0.0001
74076568|NCT01854047|147707135|SUPERIORITY||LS Mean Difference|0.12||||0.0048|TWO_SIDED|95.0|0.04|0.21||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w|||0.21|0.04|0.0048
74076569|NCT01854047|147707135|SUPERIORITY||LS Mean Difference|0.1||||0.0304|TWO_SIDED|95.0|0.01|0.18||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w|||0.18|0.01|0.0304
74076570|NCT01085825|147707157|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||.13
74076571|NCT03653507|147707174|SUPERIORITY||Hazard Ratio (HR)|0.689||||0.0005|TWO_SIDED|95.0|0.552|0.86|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||0.860|0.552|0.0005
74076572|NCT03653507|147707175|SUPERIORITY||Hazard Ratio (HR)|0.763||||0.0047|TWO_SIDED|95.0|0.622|0.936|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||0.936|0.622|0.0047
74076573|NCT03653507|147707176|SUPERIORITY||Hazard Ratio (HR)|1.012||||0.4654|TWO_SIDED|95.0|0.772|1.328|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.328|0.772|0.4654
74076574|NCT03653507|147707177|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.4478|TWO_SIDED|95.0|0.673|1.577|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.577|0.673|0.4478
74076575|NCT03653507|147707178|SUPERIORITY||Hazard Ratio (HR)|0.869||||0.167|TWO_SIDED|95.0|0.655|1.153|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.153|0.655|0.1670
74076576|NCT03653507|147707179|SUPERIORITY|||||||0.2219||||||Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.|Cochran-Mantel-Haenszel|||||||0.2219
74076577|NCT03653507|147707180|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.0826|TWO_SIDED|95.0|0.552|1.105|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.105|0.552|0.0826
74076578|NCT03697109|147707189|EQUIVALENCE|Log odds is equal to 0 (null hypothesis) vs log odds not equal to 0 (alternative hypothesis).|Odds Ratio (OR)|0.17||||0.0215|TWO_SIDED|95.0|0.04|0.77|||Chi-squared||An odds ratio (OR) \<1 represents lower odds of loss of response under treatment with relacorilant compared with treatment with placebo.|A logistic regression model with logit link function was used in order to detect if there was a significant difference in total number of patients with a loss of response with respect to HTN under treatment with relacorilant compared with treatment with placebo in the RW Phase.||0.77|0.04|0.0215
73885096|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.622|TWO_SIDED|95.0|-0.48|0.8||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||0.80|-0.48|0.622
74076579|NCT01281501|147707228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_DEVIATION|5.0||0.6|TWO_SIDED|95.0|-12.7|7.4|||t-test, 2 sided|||Null hypothesis is that the treatment with pantoprazole arm is not different in immediate relief of acute, severe dyspeptic pain compared with conventional arm.||7.4|-12.7|0.6
74076580|NCT00834522|147707233|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.79||||||90.0|99.4|108.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.37|99.40|
74076581|NCT00834522|147707234|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.37||||||90.0|97.04|112.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.25|97.04|
74076582|NCT00834522|147707235|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.22||||||90.0|96.9|112.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.08|96.90|
73888370|NCT03594110|147309583|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.64|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of ESKD. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.64|
74076583|NCT04516967|147707236|SUPERIORITY|||||||0.0077|||||||Fisher Exact|||||||0.0077
74076584|NCT04516967|147707237|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74076585|NCT04516967|147707238|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74076586|NCT04516967|147707239|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74076587|NCT04516967|147707240|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
74076588|NCT04516967|147707241|SUPERIORITY|||||||0.0008|||||||Fisher Exact|||||||0.0008
74076589|NCT04516967|147707242|SUPERIORITY|||||||0.7175|||||||Fisher Exact|||||||0.7175
74076590|NCT02996591|147707272|OTHER||generalized estimating equations method|45.0||||0.038|TWO_SIDED||||||Regression, Logistic|||||||.038
74076591|NCT02996591|147707272|OTHER|Bang blinding index|||||<|0.001|||||||Bang Blinding Index|95% confidence interval||||||<.001
74076592|NCT00461786|147707281|SUPERIORITY_OR_OTHER||Overall Response Rate|21.0||||||95.0|10.5|35.0||||||Overall Response Rate is the total percentage of participants with either a complete response or a partial response (CR+PR)/48 X 100.||35.0|10.5|
73885097|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.153|TWO_SIDED|95.0|-0.18|1.16||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.16|-0.18|0.153
73888545|NCT01929317|147309697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 6.|||0.3|-0.4|
74076593|NCT00835991|147707286|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|114.05||||||90.0|107.26|121.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||121.27|107.26|
74076594|NCT00835991|147707287|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.63||||||90.0|97.59|103.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.76|97.59|
74076595|NCT00835991|147707288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.36||||||90.0|98.32|104.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.48|98.32|
74076596|NCT00835991|147707289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.05||||||90.0|94.31|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.02|94.31|
74076597|NCT00835991|147707290|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05|Test/Ref Ratio of LS Means x 100|96.55||||||90.0|93.85|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.32|93.85|
74076598|NCT00835991|147707291|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.44||||||90.0|93.71|99.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.25|93.71|
74076599|NCT02149420|147707292|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_DEVIATION|2.058||0.678|TWO_SIDED|95.0|-5.007|3.18|||repeated measures Bayesian analysis|with baseline as a covariate||Per protocol the primary analysis was between placebo and the combined VAY736 groups at Week 12.||3.180|-5.007|0.678
74076600|NCT00984022|147707390|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Fisher Exact|||The percentages achieving 30% or greater reduction in the surface area of the abscess were compared with Fisher's exact test.||||.0003
74076601|NCT00984022|147707391|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||Main effect for type of dressing.|ANOVA|||Repeated measures ANOVA using 2 X 2 factorial design, with one between-subjects factor (Group) and one within-subjects factor (Time). Null hypothesis is: The type of dressing does not affect patient pain ratings.||||.043
74076602|NCT00984022|147707392|SUPERIORITY_OR_OTHER|||||||0.847||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the percentage of individuals achieving a 30% or greater reduction in cellulitis surface area between the Iodoform and Aquacel groups.||||.847
74076603|NCT00573443|147707394|SUPERIORITY_OR_OTHER||Ratio of episode-rate reduction ratios|0.5312|||<|0.0001|TWO_SIDED|95.0|0.4939|0.5714|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-30/placebo = 1.||0.5714|0.4939|<0.0001
74076604|NCT00573443|147707394|SUPERIORITY_OR_OTHER||Ratio of episode-rate reduction ratios|0.5103|||<|0.0001|TWO_SIDED|95.0|0.4755|0.5477|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-20/placebo = 1.||0.5477|0.4755|<0.0001
74076605|NCT00905606|147707401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|93.91||||||90.0|85.42|103.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.25|85.42|
74076606|NCT00905606|147707402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.27||||||90.0|94.63|102.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.05|94.63|
73885098|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.344|TWO_SIDED|95.0|-0.35|1.0||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.00|-0.35|0.344
73885099|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.058|TWO_SIDED|95.0|-0.02|1.45||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||1.45|-0.02|0.058
73888371|NCT03594110|147309584|OTHER||Mean Difference (Net)|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.11|||Mixed Models Analysis||\[Comparator\] - \[Placebo\]|A mixed model of repeated measures (MMRM) with terms for baseline, age, sex, screening diabetes status, local screening eGFR, local screening UACR, treatment, treatment-by-time interaction and baseline-by-time interaction.||-0.11|-0.38|< 0.001
74076607|NCT00905606|147707403|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.19||||||90.0|94.64|101.87|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.87|94.64|
74076608|NCT00804856|147707417|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.91||||0.0523|TWO_SIDED|95.0|0.99|8.58|||Regression, Logistic||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|Analysis for Objective Response||8.58|0.99|0.0523
74076609|NCT00804856|147707421|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.0208|TWO_SIDED|95.0|0.35|0.92|||Log Rank||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|An exploratory (non-stratified) logrank test was used to compare the different treatment arms.||0.92|0.35|0.0208
74076610|NCT00804856|147707422|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0465|TWO_SIDED|95.0|0.4|1.0|||Log Rank||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|An exploratory (non-stratified) logrank test was used to compare the different treatment arms.||1.00|0.40|0.0465
74076611|NCT00418561|147707442|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0737|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using analysis of variance (ANOVA) model including the baseline measurement as a covariate.||||0.0737
74076612|NCT00418561|147707443|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1115|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.||||0.1115
74076613|NCT00418561|147707445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1268|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.||||0.1268
74076614|NCT00829309|147707468|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.45||||||90.0|80.08|121.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||121.03|80.08|
74076615|NCT00829309|147707469|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|90.98||||||90.0|85.23|97.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.12|85.23|
74076616|NCT00829309|147707470|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|96.3||||||90.0|85.34|108.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.66|85.34|
74076617|NCT02246920|147707506|EQUIVALENCE|Equivalence is established if the 90% confidence interval is contained within 80.00-125.00%.|T/R Ls Mean Ratio|108.09|||||TWO_SIDED|90.0|94.09|124.4||||||||124.40|94.09|
74076618|NCT02246920|147707507|EQUIVALENCE|Equivalence is demonstrated when the 90% confidence interval is contained within 80.00-125.00%.|T/R LS Mean Ratio|107.0|||||TWO_SIDED|90.0|92.42|124.09||||||||124.09|92.42|
74076619|NCT02246920|147707508|SUPERIORITY|||||||0.0028|||||||ANCOVA|||||||0.0028
74076620|NCT02246920|147707508|SUPERIORITY|||||||0.0169|||||||ANCOVA|||||||0.0169
74076621|NCT02937870|147707542|OTHER||Least square (LS) mean difference|0.66||||0.177|TWO_SIDED|95.0|-0.14|1.47||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||1.47|-0.14|0.1770
73885100|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.032|TWO_SIDED|95.0|0.07|1.59||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||1.59|0.07|0.032
73888546|NCT01929317|147309697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 8.|||0.3|-0.3|
74076622|NCT02937870|147707543|OTHER||LS mean difference|-0.2||||0.8321|TWO_SIDED|95.0|-0.98|0.59||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||0.59|-0.98|0.8321
74076623|NCT02937870|147707544|OTHER||LS mean difference|0.07||||0.8566|TWO_SIDED|95.0|-0.72|0.87|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||0.87|-0.72|0.8566
74076624|NCT02937870|147707545|OTHER||LS mean difference|-0.79||||0.0488|TWO_SIDED|95.0|-1.58|0.0|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||-0.00|-1.58|0.0488
74076625|NCT02937870|147707546|OTHER||LS mean difference|0.86||||0.0352|TWO_SIDED|95.0|0.06|1.66|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||1.66|0.06|0.0352
74076626|NCT00609674|147707549|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|||||||0.004
74076627|NCT00571064|147707575|SUPERIORITY_OR_OTHER|||||||0.6593|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||0.6593
74076628|NCT00571064|147707575|SUPERIORITY_OR_OTHER|||||||0.6048|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.6048
74076629|NCT00571064|147707575|SUPERIORITY_OR_OTHER|||||||0.5924|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.5924
74076630|NCT00571064|147707576|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||<0.0001
74076631|NCT00571064|147707576|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||<0.0001
74076632|NCT00571064|147707576|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||<0.0001
74076633|NCT00571064|147707578|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.0431
74076634|NCT00571064|147707578|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.0431
73885101|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.762|TWO_SIDED|95.0|-0.66|0.9||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||0.90|-0.66|0.762
73888547|NCT01929317|147309697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 12.|||0.6|-0.2|
74076635|NCT00571064|147707580|SUPERIORITY_OR_OTHER|||||||0.1285|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.1285
74076636|NCT00571064|147707580|SUPERIORITY_OR_OTHER|||||||0.1285|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.1285
74076637|NCT00571064|147707582|SUPERIORITY_OR_OTHER|||||||0.2327|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||0.2327
74076638|NCT00571064|147707582|SUPERIORITY_OR_OTHER|||||||0.4724|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.4724
74076639|NCT00571064|147707582|SUPERIORITY_OR_OTHER|||||||0.4724|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF - Study Endpoint||||0.4724
74076640|NCT00244764|147707583|SUPERIORITY_OR_OTHER||percentage|34.7||||||95.0|28.4|40.9|||||The estimated value provided is the response rate.|||40.9|28.4|
74076641|NCT00244764|147707584|SUPERIORITY_OR_OTHER||percentage|42.0||||||95.0|29.0|54.0|||||The estimated value is the percentage of the first 60 participants who had stable disease at Week 12, as assessed by the investigator.|||54|29|
74076642|NCT03872128|147707591|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
74076643|NCT03872128|147707592|SUPERIORITY|||||||0.019|||||||Fisher Exact|||||||0.019
74076644|NCT03872128|147707593|SUPERIORITY|||||||0.044|||||||Fisher Exact|||||||0.044
74076645|NCT03872128|147707594|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||OCDS: Total||||<0.001
74076646|NCT03872128|147707594|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||OCDS: Obsessive||||<0.001
74076647|NCT03872128|147707594|SUPERIORITY|||||||0.003|||||||Fisher Exact|||OCDS: Compulsive||||0.003
74076648|NCT03872128|147707596|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
74076649|NCT03872128|147707597|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||HADS-Depression||||<0.001
74076650|NCT03872128|147707597|SUPERIORITY|||||||0.089|||||||Fisher Exact|||HADS-Anxiety||||0.089
74076651|NCT03285594|147707600|SUPERIORITY||Difference in Least Square (LS) Means|-0.45|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.638|-0.271|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||-0.271|-0.638|<0.0001
73885102|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.029|TWO_SIDED|95.0|0.09|1.73||P-value is for de novo, week 3. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.73|0.09|0.029
73885103|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12||||0.01|TWO_SIDED|95.0|0.27|1.97||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.97|0.27|0.010
73885104|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.619|TWO_SIDED|95.0|-0.63|1.06||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.06|-0.63|0.619
73885105|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.058|TWO_SIDED|95.0|-0.03|1.69||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.||1.69|-0.03|0.058
73885106|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.001|TWO_SIDED|95.0|0.61|2.41||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.||2.41|0.61|0.001
74076652|NCT03285594|147707600|SUPERIORITY||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-0.706|-0.387|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||-0.387|-0.706|<0.0001
73885107|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.142|TWO_SIDED|95.0|-0.23|1.58||P-value is for de nove, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.58|-0.23|0.142
73885108|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.065|TWO_SIDED|95.0|-0.05|1.76||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||1.76|-0.05|0.065
74076653|NCT03285594|147707601|SUPERIORITY||Difference in LS Means|-15.858|STANDARD_ERROR_OF_MEAN|4.6056||0.0006|TWO_SIDED|95.0|-24.8845|-6.8309|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.||-6.8309|-24.8845|0.0006
74076654|NCT03285594|147707601|SUPERIORITY||Difference in LS Means|-21.832|STANDARD_ERROR_OF_MEAN|4.0514|<|0.0001|TWO_SIDED|95.0|-29.7725|-13.8911|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.||-13.8911|-29.7725|<0.0001
73888372|NCT03594110|147309585|OTHER||Mean Difference (Net)|-12.0||||0.41|TWO_SIDED|95.0|-42.0|17.0|||Regression, Linear||\[Comparator\]-\[Placebo\]|Differences in MRI measurements between treatment groups were assessed using a linear regression with terms for age, sex, screening diabetes status, local screening eGFR, local screening UACR was used in the analysis.||17|-42|0.41
73888373|NCT05571605|147309588|OTHER|||||||0.05|||||||ANOVA|||||||0.05
74076655|NCT03285594|147707602|SUPERIORITY||Difference in LS Means|-1.09|STANDARD_ERROR_OF_MEAN|0.32||0.0007|TWO_SIDED|95.0|-1.716|-0.462|||ANCOVA|||The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||-0.462|-1.716|0.0007
74076656|NCT03285594|147707602|SUPERIORITY||Difference in LS Means|-1.73|STANDARD_ERROR_OF_MEAN|0.278|<|0.0001|TWO_SIDED|95.0|-2.274|-1.183|||ANCOVA|||The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||-1.183|-2.274|<0.0001
74076657|NCT03285594|147707603|SUPERIORITY||Difference in LS Means|-3.91|STANDARD_ERROR_OF_MEAN|1.904||0.04|TWO_SIDED|95.0|-7.642|-0.178|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-0.178|-7.642|0.04
74076658|NCT03285594|147707603|SUPERIORITY||Difference in LS Means|-3.83|STANDARD_ERROR_OF_MEAN|1.697||0.0239|TWO_SIDED|95.0|-7.161|-0.507|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-0.507|-7.161|0.0239
74076659|NCT03285594|147707604|SUPERIORITY||Difference in LS Means|-4.94|STANDARD_ERROR_OF_MEAN|1.425|||TWO_SIDED|95.0|-7.73|-2.142||||||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-2.142|-7.73|
74076660|NCT03285594|147707604|SUPERIORITY||Difference in LS Means|-3.89|STANDARD_ERROR_OF_MEAN|1.246||0.0018|TWO_SIDED|95.0|-6.333|-1.448|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-1.448|-6.333|0.0018
74076661|NCT03285594|147707605|SUPERIORITY||Difference in LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.34||0.1265|TWO_SIDED|95.0|-1.185|0.147|||ANCOVA|||The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||0.147|-1.185|0.1265
74076662|NCT03285594|147707605|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.32||0.074|TWO_SIDED|95.0|-1.199|0.055|||ANCOVA|||The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||0.055|-1.199|0.074
74076663|NCT03285594|147707606|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.868||0.2466|TWO_SIDED|95.0|-2.707|0.696|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||0.696|-2.707|0.2466
74076664|NCT03285594|147707606|SUPERIORITY||Difference in LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.672||0.332|TWO_SIDED|95.0|-1.969|0.665|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||0.665|-1.969|0.332
74076665|NCT03273153|147707627|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.2954|TWO_SIDED|95.0|0.88|1.5|||Regression, Cox|||||1.50|0.88|0.2954
74076666|NCT05323396|147707644|OTHER|||||||0.19|||||||Student's unpaired t-test|||||||0.19
74076667|NCT05323396|147707645|OTHER|||||||0.85|||||||Student's unpaired t-test|||||||0.85
74076668|NCT05323396|147707646|OTHER|||||||0.77|||||||Student's unpaired t-test|||||||0.77
74076669|NCT05323396|147707647|OTHER|||||||0.12|||||||student's unpaired t-test|||||||0.12
74076670|NCT05323396|147707648|OTHER|||||||0.81|||||||student's unpaired t-test|||||||0.81
74076671|NCT05323396|147707649|OTHER|||||||0.65|||||||student's unpaired t-test|||||||0.65
74076672|NCT00095212|147707675|SUPERIORITY_OR_OTHER|||||||0.04|||||||longitudinal linear mixed effects model|||||||0.04
74076673|NCT00095212|147707676|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Longitudinal linear mixed effects model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.02
74076674|NCT00095212|147707677|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.02
74076675|NCT00095212|147707678|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.01
74076676|NCT00095212|147707679|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Chi-squared|||||||0.16
74076677|NCT00095212|147707680|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Chi-squared|||||||0.29
74076678|NCT00095212|147707681|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Chi-squared|||||||0.75
74076679|NCT00095212|147707682|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
74076680|NCT00095212|147707683|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||t-test, 2 sided|||||||0.26
73885109|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|0.75|2.65||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||2.65|0.75|<0.001
73885110|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.079|TWO_SIDED|95.0|-0.1|1.79||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||1.79|-0.10|0.079
74076681|NCT00095212|147707684|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
74076682|NCT00095212|147707685|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||||||0.94
74076683|NCT04934722|147707718|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.24|2.34|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.34|0.24|
74076684|NCT04934722|147707719|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.3|6.01|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||6.01|0.30|
74076685|NCT04934722|147707720|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.5|3.63|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.63|0.50|
74076686|NCT04934722|147707722|OTHER||Hazard Ratio (HR)|3.15|||||TWO_SIDED|95.0|0.33|30.29|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||30.29|0.33|
74076687|NCT04934722|147707723|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.11|4.07|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||4.07|0.11|
74076688|NCT04934722|147707724|OTHER||Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.73|2.9|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.90|0.73|
74076689|NCT04934722|147707725|OTHER||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.42|7.34|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||7.34|0.42|
74076690|NCT04934722|147707726|OTHER||Percent Difference|-5.5|||||TWO_SIDED|95.0|-12.6|0.0|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||0.0|-12.6|
74076691|NCT04934722|147707727|OTHER||Percent difference|-0.7|||||TWO_SIDED|95.0|-15.0|13.7|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||13.7|-15.0|
74076692|NCT04934722|147707728|OTHER||Percent difference|7.8|||||TWO_SIDED|95.0|-12.5|27.1|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||27.1|-12.5|
74076693|NCT00834795|147707744|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|95.16||||||90.0|85.69|105.67|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.67|85.69|
74076694|NCT00834795|147707745|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.27||||||90.0|90.34|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.59|90.34|
74076695|NCT00834795|147707746|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.36||||||90.0|90.2|102.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.93|90.20|
74076696|NCT00579345|147707752|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.66|||||TWO_SIDED|95.0|0.45|0.98|||||A/H1N1(Day22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||0.98|0.45|
74076697|NCT00579345|147707752|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.55|1.19|||||A/H3N2 (Day 22)-criterion was met|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||1.19|0.55|
74076698|NCT00579345|147707752|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.69|||||TWO_SIDED|95.0|0.46|1.02|||||B (Day 22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||1.02|0.46|
74076699|NCT03612960|147707769|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.14|0.43|||t-test, 2 sided||||The mean percent change in BOLD signal used for this t-test was extracted from a brain cluster with significant group differences in changes in activation over time (voxel p\<.05, cluster p\<.05) identified using a whole-brain, voxel-wise two-way mixed effect ANOVA with FSL software.|0.43|0.14|<.001
74076700|NCT03612960|147707770|SUPERIORITY||Mean Difference (Final Values)|-8.38|STANDARD_ERROR_OF_MEAN|4.33||0.063|TWO_SIDED|95.0|-17.24|0.48|||t-test, 2 sided|||||0.48|-17.24|.063
74076701|NCT03612960|147707771|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|9.86||0.89|TWO_SIDED|95.0|-21.57|18.82|||t-test, 2 sided|||||18.82|-21.57|0.890
74076702|NCT00272779|147707772|SUPERIORITY_OR_OTHER||Difference Estimate|1.7|||||TWO_SIDED|95.0|-3.8|7.1||Assuming 70% response rate (70% of participants remain on treatment for 48 wks and HIV RNA \<50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV|Cochran-Mantel-Haenszel|The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions \> -10%.||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting||7.1|-3.8|
74076703|NCT00272779|147707773|SUPERIORITY_OR_OTHER||Difference Estimate|3.3|||||TWO_SIDED|95.0|-1.5|8.1|||Cochran-Mantel-Haenszel|||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).||8.1|-1.5|
74076704|NCT00272779|147707776|SUPERIORITY_OR_OTHER||Difference Estimate|-16.4|||||TWO_SIDED|95.0|-35.9|3.1|||95% CI comparison of difference|||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.||3.1|-35.9|
74076705|NCT00272779|147707798|SUPERIORITY_OR_OTHER||Difference Estimate|6.1|||||TWO_SIDED|95.0|0.3|12.0||Assuming 70% response rate (70% of participants remain on treatment for 96 wks and HIV RNA \<50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV|Cochran-Mantel-Haenszel|The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions \> -10%.||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting||12.0|0.3|
74076706|NCT00272779|147707799|SUPERIORITY_OR_OTHER||Difference Estimate|5.1|||||TWO_SIDED|95.0|-0.4|10.6|||Cochran-Mantel-Haenszel|||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).||10.6|-0.4|
74076707|NCT00272779|147707801|SUPERIORITY_OR_OTHER||Difference Estimate|-21.2|||||TWO_SIDED|95.0|-43.3|0.9|||95% CI comparison of difference|||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.||0.9|-43.3|
74076708|NCT00272779|147707817|SUPERIORITY_OR_OTHER||point estimate|0.761|||||TWO_SIDED|90.0|0.507|1.142|||ANOVA||Point estimates and 90% confidence intervals (CIs) for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.142|0.507|
74076709|NCT00272779|147707818|SUPERIORITY_OR_OTHER||point estimate|1.46|||||TWO_SIDED|90.0|1.005|2.121|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||2.121|1.005|
74076710|NCT00272779|147707819|SUPERIORITY_OR_OTHER||point estimate|0.839|||||TWO_SIDED|90.0|0.612|1.151|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.151|0.612|
74076711|NCT00272779|147707820|SUPERIORITY_OR_OTHER||point estimate|0.282|||||TWO_SIDED|90.0|0.181|0.439|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||0.439|0.181|
74076712|NCT00272779|147707821|SUPERIORITY_OR_OTHER||point estimate|0.925|||||TWO_SIDED|90.0|0.699|1.223|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.223|0.699|
74076713|NCT00272779|147707822|SUPERIORITY_OR_OTHER||point estimate|0.853|||||TWO_SIDED|90.0|0.626|1.161|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.161|0.626|
74076714|NCT00272779|147707823|SUPERIORITY_OR_OTHER||point estimate|0.89|||||TWO_SIDED|90.0|0.689|1.151|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.151|0.689|
74076715|NCT00272779|147707847|SUPERIORITY_OR_OTHER|||||||0.0847||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting non-HDL cholesterol (phenotype) and the RETN\_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.0847
74076716|NCT00272779|147707848|SUPERIORITY_OR_OTHER|||||||0.0058||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.0058
73885111|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.093|TWO_SIDED|95.0|-0.13|1.71||P-value is for de novo, 6 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||1.71|-0.13|0.093
74076717|NCT00272779|147707849|SUPERIORITY_OR_OTHER|||||||0.0058||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_2265 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_2265 reported in Outcome Measure 16.||||0.0058
74076718|NCT00272779|147707850|SUPERIORITY_OR_OTHER|||||||0.0253||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_598 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_598 reported in Outcome Measure 16.||||0.0253
74076719|NCT00272779|147707851|SUPERIORITY_OR_OTHER|||||||0.1173||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the APOE\_C130R genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE\_C130R reported in Outcome Measure 16.||||0.1173
73885112|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56||||0.002|TWO_SIDED|95.0|0.59|2.53||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||2.53|0.59|0.002
73888374|NCT00684021|147309595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|2.0||0.959|TWO_SIDED|95.0|-4.1|3.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||3.9|-4.1|0.959
73888375|NCT00684021|147309596|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.93|TWO_SIDED|95.0|0.42|2.23|||Fisher Exact|||Clinical and Safety Outcomes including death, reinfarction, repeat revascularization, hospitalization for heart failure and ICD placement. The relative incidences of events are compared between the active and placebo groups.However the paucity of events precluded a reliable time to event analysis.||2.23|0.42|0.93
74076720|NCT00272779|147707852|SUPERIORITY_OR_OTHER|||||||0.1173||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_734 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_734 reported in Outcome Measure 16.||||0.1173
74076721|NCT00272779|147707853|SUPERIORITY_OR_OTHER|||||||0.1847||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting PAI-1 (phenotype) and the APOE\_R176C genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE\_R176C reported in Outcome Measure 16.||||0.1847
74076722|NCT00272779|147707854|SUPERIORITY_OR_OTHER|||||||0.1833||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis:There is no association between the mean change from baseline in fasting Tumor Necrosis Factor(TNF)-alpha (phenotype) and the IL6\_5309 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, wk48 and 96) to test the overall genotype effect (ie. an omnibus test on both marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with IL6\_5309 reported in Outcome Measure 16||||0.1833
74076723|NCT00272779|147707855|SUPERIORITY_OR_OTHER|||||||0.1833||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting TNF-alpha (phenotype) and the RS11030679 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.1833
74076724|NCT00272779|147707856|SUPERIORITY_OR_OTHER|||||||0.1694||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in SAT-to-TAT Ratio (phenotype) and the CCDC122\_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDC122\_5980 reported in Outcome Measure 16.||||0.1694
74076725|NCT00272779|147707857|SUPERIORITY_OR_OTHER|||||||0.1335||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the BRUNOL\_1842 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with BRUNOL\_1842 reported in Outcome Measure 16.||||0.1335
74076726|NCT00272779|147707858|SUPERIORITY_OR_OTHER|||||||0.1335||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the RETN\_730 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_730 reported in Outcome Measure 16.||||0.1335
74076727|NCT00272779|147707859|SUPERIORITY_OR_OTHER|||||||0.1696||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT-to-TAT Ratio (phenotype) and the CCDA122\_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDA122\_5980 reported in Outcome Measure 16.||||0.1696
74076728|NCT01415232|147707860|NON_INFERIORITY_OR_EQUIVALENCE|Balki et al found a Pearson's correlation coefficient between the UD and ND depth of 0.85 (95% CI 0.75-0.91). We believe EDE + US would result in a correlation coefficient of approximately 0.91. To keep the lower bound estimate within 0.04 of a correlation of 0.91, and to maintain a 95% confidence level, 140 patients would need to be sampled. To allow for patients who may not complete the study, 160 patients were enrolled.|correlation coefficient|0.91|||<|0.05|TWO_SIDED|95.0|0.87|0.93|||longitudinal correlation coefficient|||Pearson's correlation coefficient was calculated for epidural distance measurements which included actual clinical epidural needle depth (ND) and the epidural depth equation (EDE), ND and prior EDE + US midline longitudinal plane view, ND and prior EDE + US transverse plane view.||0.93|0.87|< 0.05
74076729|NCT01415232|147707860|NON_INFERIORITY_OR_EQUIVALENCE|correlation coefficient|transverse plane correlation coefficient|0.9|||>|0.85|TWO_SIDED|95.0|0.87|0.93|||transverse plane correlation coefficient|||Transverse plane correlation coefficient||0.93|0.87|>0.85
74076730|NCT01415232|147707860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.64|STANDARD_DEVIATION|1.0|>|0.05|TWO_SIDED|95.0|6.5|6.8|||t-test, 2 sided|||Clinical epidural needle depth||6.8|6.5|>0.05
74076731|NCT01415232|147707860|SUPERIORITY_OR_OTHER||Formula calculation|6.54|STANDARD_DEVIATION|0.68|>|0.05|TWO_SIDED|95.0|6.44|6.65|||Formula calculation||Estimated epidural depth equation depth (cm)|Estimated epidural depth equation depth (cm)||6.65|6.44|>0.05
74076732|NCT02440711|147707879|SUPERIORITY|||||||0.18||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at slow walking speed||||.18
73888376|NCT00684021|147309597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|4.8||0.585|TWO_SIDED|95.0|-12.2|6.9|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||6.9|-12.2|0.585
74076733|NCT02440711|147707879|SUPERIORITY|||||||0.21||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at comfortable walking speed||||.21
74076734|NCT02440711|147707879|SUPERIORITY|||||||0.16||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at fast walking speed||||.16
74076735|NCT02440711|147707881|SUPERIORITY|||||||0.29||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.29
74076736|NCT02440711|147707883|SUPERIORITY|||||||0.05||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.05
74076737|NCT02440711|147707885|SUPERIORITY|||||||0.25||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.25
74076738|NCT02440711|147707887|SUPERIORITY|||||||0.86||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.86
74076739|NCT02440711|147707889|SUPERIORITY|||||||0.14||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Prosthetic side step length results||||.14
74076740|NCT02440711|147707889|SUPERIORITY||||||<|0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Sound side step length results||||<0.001
74076741|NCT02440711|147707891|SUPERIORITY|||||||0.61||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Prosthetic side step time results||||.61
74076742|NCT02440711|147707891|SUPERIORITY|||||||0.4||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Sound side step time results||||.40
74076743|NCT02440711|147707893|SUPERIORITY|||||||0.14||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.14
74076744|NCT02440711|147707895|SUPERIORITY|||||||0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.001
74076745|NCT02440711|147707897|SUPERIORITY|||||||0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.001
74076746|NCT02440711|147707899|SUPERIORITY|||||||0.005||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.005
74076747|NCT02440711|147707901|SUPERIORITY|||||||0.002||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-AR results||||0.002
74076748|NCT02440711|147707901|SUPERIORITY||||||<|0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-FUN results||||<0.001
74076749|NCT02440711|147707901|SUPERIORITY|||||||0.85||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-AES results||||0.85
74076750|NCT01980771|147707903|SUPERIORITY||Odds Ratio (OR)|1.58||||0.04|TWO_SIDED|95.0|1.03|2.43|||Mixed Models Analysis|||||2.43|1.03|0.04
74076751|NCT00968812|147707947|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride.|Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.109|0.085|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus glimepiride\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.||0.085|-0.109|
74076752|NCT00968812|147707947|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride|Least-Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.217|-0.023|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus glimepiride\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.||-0.023|-0.217|
74076753|NCT00968812|147707948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.06|0.16|||Regression, Logistic|||||0.16|0.06|<0.001
74076754|NCT00968812|147707948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09|||<|0.001|TWO_SIDED|95.0|0.05|0.14|||Regression, Logistic|||||0.14|0.05|<0.001
74076755|NCT00968812|147707949|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-5.7|-4.7|||ANCOVA|||||-4.7|-5.7|<0.001
74076756|NCT00968812|147707949|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-6.2|-5.1|||ANCOVA|||||-5.1|-6.2|<0.001
74076757|NCT00968812|147707950|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.2|0.01|||ANCOVA|||||0.010|-0.200|
74076758|NCT00968812|147707950|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.289|-0.078|||ANCOVA|||||-0.078|-0.289|
74076759|NCT02648438|147707967|SUPERIORITY_OR_OTHER||Geometric mean ratio|62.61|||||TWO_SIDED|90.0|53.01|73.94|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.||73.94|53.01|
73885113|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.119|TWO_SIDED|95.0|-0.2|1.74||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||1.74|-0.20|0.119
74076760|NCT02648438|147707968|SUPERIORITY_OR_OTHER||Geometric mean ratio|101.15|||||TWO_SIDED|90.0|85.21|120.06|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.||120.06|85.21|
74076761|NCT05615935|147707979|SUPERIORITY||Adjusted Mean Difference (ANCOVA)|2.07|||<|0.001|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|ANCOVA|||Using G\*Power 3.1, the required sample size for ANCOVA with two groups was estimated with a significance level of 0.05, statistical power of 0.80, and an effect size of 0.35, based on Cohen's guidelines for a medium-to-large effect commonly applied in behavioral research (Cohen, 1988). Assuming up to two covariates, a minimum of 67 participants was required. Accounting for a 10% attrition rate, the final target was set at 74 participants.||||<0.001
74076762|NCT05615935|147707980|SUPERIORITY||Adjusted Mean Difference (ANCOVA)|4.58||||0.15|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|ANCOVA|||||||0.15
74076763|NCT05615935|147707980|SUPERIORITY||Median Difference (Final Values)|-2.64|STANDARD_DEVIATION|6.35||0.02|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|t-test, 2 sided|||||||0.02
74076764|NCT05446870|147707984|OTHER||Posterior probability (%)|100.0|||||||||||||||Posterior probability (based on 20000 sets of model parameters) ctDNA fold change (square root scale) coefficient less than zero in the multivariable logistic regression model of pCR, adjusted for baseline ctDNA and treatment assignment.|||
74076765|NCT05446870|147707986|OTHER||Posterior probability (%)|90.99|||||||||||||||Posterior probability (based on 20000 sets of model parameters) ctDNA fold change (square root scale) coefficient less than zero in the multivariable logistic regression model of CRS (CRS3 coded as 1 and CRS1 or 2 coded as 0), adjusted for baseline ctDNA and treatment assignment.|||
74076766|NCT05446870|147707987|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC + MK-4830 arm - % Pembrolizumab + SOC arm) and 95% confidence interval (CI) were based on Miettinen \& Nurminen method.|Difference in Percentage|1.1|||||TWO_SIDED|95.0|-10.0|12.9||||||||12.9|-10.0|
74076767|NCT05446870|147707988|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC + MK-4830 arm - % Pembrolizumab + SOC arm) and 95% CI were based on Miettinen \& Nurminen method.|Difference in Percentage|20.7|||||TWO_SIDED|95.0|3.5|37.0||||||||37.0|3.5|
74076768|NCT05446870|147707991|OTHER||Posterior probability (%)|38.75|||||||||||||||Posterior probability (based on 20000 sets of model parameters) coefficient for treatment assignment (MK-4830 containing vs. not) less than zero in Bayesian parametrization of the constrained longitudinal data analysis (cLDA) model, modeling ctDNA value at Cycle 3 and ctDNA value at baseline as bivariate normal.|||
74076769|NCT02446600|147707999|SUPERIORITY||Hazard Ratio (HR)|0.856||||0.077|TWO_SIDED|95.0|0.663|1.105||The p-value is one-sided. Per the protocol, the statistical significance threshold was \<0.025. Type 1 error was controlled using hierarchical testing strategy.|Log Rank|The log rank test was stratified by the minimization factors provided at randomization|The hazard ratio estimate compares olaparib+cedirinib to chemotherapy. If olaparib+cedirinib is superior, the hazard ratio is \<1.0.|Arm II was suspended for futility at the interim analysis so was not analyzed at the final analysis.||1.105|0.663|0.077
74076770|NCT01935934|147708066|OTHER||||||||||||||||||"Trial design discriminated between co-primary endpoints of objective RR of 30% (vs 10%) and 12-week PFS of 55% (vs 30%). The design had 86% power to detect a true objective RR of at least 30% and at least 90% power to detect a true 12-week PFS rate of atleast 55% (or a median PFS of 3.4 months).~The parallel exploratory cohort of uncommon histology cancers was analyzed independently."|||
74076771|NCT04608188|147708075|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
74076772|NCT04608188|147708076|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
74076773|NCT04608188|147708077|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
74076774|NCT04608188|147708078|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
74076775|NCT00838136|147708079|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.23||||||90.0|99.88|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.60|99.88|
74076776|NCT00838136|147708080|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.87||||||90.0|99.18|104.63|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.63|99.18|
74076777|NCT00838136|147708081|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.76||||||90.0|98.6|102.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.97|98.60|
74076778|NCT02869867|147708162|SUPERIORITY||Mean Difference (Final Values)|3.2|||<|0.001|TWO_SIDED|95.0|2.09|4.31|||Mixed Models Analysis|||||4.31|2.09|<0.001
74076779|NCT03570749|147708163|SUPERIORITY||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|2.75|12.02|||Regression, Logistic|||||12.02|2.75|<0.001
74076780|NCT03570749|147708163|SUPERIORITY||Odds Ratio (OR)|11.8|||<|0.001|TWO_SIDED|95.0|5.89|23.62|||Regression, Logistic|||||23.62|5.89|<0.001
74076781|NCT03570749|147708164|SUPERIORITY||Odds Ratio (OR)|3.92|||<|0.001|TWO_SIDED|95.0|1.81|8.51|||Regression, Logistic|||||8.51|1.81|<0.001
74076782|NCT03570749|147708164|SUPERIORITY||Odds Ratio (OR)|10.26|||<|0.001|TWO_SIDED|95.0|5.05|20.87|||Regression, Logistic|||||20.87|5.05|<0.001
74076783|NCT03570749|147708165|SUPERIORITY||Odds Ratio (OR)|5.58||||0.001|TWO_SIDED|95.0|1.97|15.83|||Regression, Logistic|||||15.83|1.97|0.001
74076784|NCT03570749|147708165|SUPERIORITY||Odds Ratio (OR)|14.34|||<|0.001|TWO_SIDED|95.0|5.3|38.83|||Regression, Logistic|||||38.83|5.30|<0.001
74076785|NCT03570749|147708166|SUPERIORITY||Odds Ratio (OR)|10.34|||<|0.001|TWO_SIDED|95.0|2.72|39.3|||Regression, Logistic|||||39.30|2.72|<0.001
74076786|NCT03570749|147708166|SUPERIORITY||Odds Ratio (OR)|18.47|||<|0.001|TWO_SIDED|95.0|5.04|67.68|||Regression, Logistic|||||67.68|5.04|<0.001
74076787|NCT03570749|147708167|SUPERIORITY||Odds Ratio (OR)|6.6|||<|0.001|TWO_SIDED|95.0|2.34|18.62|||Regression, Logistic|||||18.62|2.34|<0.001
74076788|NCT03570749|147708167|SUPERIORITY||Odds Ratio (OR)|13.58|||<|0.001|TWO_SIDED|95.0|5.01|36.81|||Regression, Logistic|||||36.81|5.01|<0.001
74076789|NCT03570749|147708168|SUPERIORITY||Odds Ratio (OR)|4.63||||0.012|TWO_SIDED|95.0|1.41|15.27|||Regression, Logistic|||||15.27|1.41|0.012
74076790|NCT03570749|147708168|SUPERIORITY||Odds Ratio (OR)|14.42|||<|0.001|TWO_SIDED|95.0|4.73|43.93|||Regression, Logistic|||||43.93|4.73|<0.001
74076791|NCT03570749|147708169|SUPERIORITY||Mean Difference (Final Values)|-23.1|STANDARD_ERROR_OF_MEAN|3.806|<|0.001|TWO_SIDED|95.0|-30.57|-15.63|||ANCOVA|||||-15.63|-30.57|<0.001
74076792|NCT03570749|147708169|SUPERIORITY||Mean Difference (Final Values)|-37.65|STANDARD_ERROR_OF_MEAN|3.447|<|0.001|TWO_SIDED|95.0|-44.24|-30.89|||ANCOVA|||||-30.89|-44.24|<0.001
74076793|NCT03570749|147708170|SUPERIORITY||Odds Ratio (OR)|2.31||||0.047|TWO_SIDED|95.0|1.01|5.29|||Regression, Logistic|||||5.29|1.01|0.047
74076794|NCT03570749|147708170|SUPERIORITY||Odds Ratio (OR)|6.03|||<|0.001|TWO_SIDED|95.0|2.91|12.51|||Regression, Logistic|||||12.51|2.91|<0.001
74076795|NCT03570749|147708172|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.288||0.005|TWO_SIDED|95.0|-1.38|-0.25|||ANCOVA|||||-0.25|-1.38|0.005
74076796|NCT03570749|147708172|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.261||0.04|TWO_SIDED|95.0|-1.05|-0.02|||ANCOVA|||||-0.02|-1.05|0.040
74076797|NCT03570749|147708173|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.259||0.107|TWO_SIDED|95.0|-0.93|0.09|||ANCOVA|||||0.09|-0.93|0.107
74076798|NCT03570749|147708173|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.234||0.174|TWO_SIDED|95.0|-0.78|0.14|||ANCOVA|||||0.14|-0.78|0.174
74076799|NCT00583453|147708222|SUPERIORITY_OR_OTHER|||||||0.674||||||Treatment x day interaction|Wilcoxon (Mann-Whitney)|||||||.674
74076800|NCT00583453|147708223|SUPERIORITY_OR_OTHER|||||||0.018||||||Treatment x day interaction reported as 0.018.|Wilcoxon (Mann-Whitney)|||||||0.018
74076801|NCT00583453|147708224|SUPERIORITY_OR_OTHER|||||||0.214||||||Treatment x day interaction = 0.214|Wilcoxon (Mann-Whitney)|||||||.214
74076802|NCT00583453|147708226|SUPERIORITY_OR_OTHER|||||||0.036||||||treatment x day interaction P = 0.036 Treatment main effect (average day 1 to 10) P = 0.003|Wilcoxon (Mann-Whitney)|||||||0.036
74076803|NCT04523168|147708239|SUPERIORITY|||||||0.0137|||||||Wilcoxon (Mann-Whitney)|||Baseline, 120 days||||0.0137
74076804|NCT04523168|147708241|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
74076805|NCT03868891|147708242|OTHER|||||||1|||||||Wilcoxon signed-rank|||inflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)||||1.00
74076806|NCT03868891|147708242|OTHER|||||||0.734|||||||Wilcoxon signed-rank|||deflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)||||0.734
74076807|NCT03868891|147708243|OTHER|||||||0.25|||||||Wilcoxon signed-rank|||inflation test at 4 months compared with baseline||||0.25
74076808|NCT03868891|147708243|OTHER|||||||0.75|||||||Wilcoxon signed-rank|||deflation test at 4 months compared with baseline||||0.75
74076809|NCT03868891|147708244|OTHER|||||||0.25|||||||Wilcoxon signed-rank|||inflation test at 4 months compared with 2 months||||0.25
74076810|NCT03868891|147708244|OTHER|||||||0.75|||||||Wilcoxon signed-rank|||deflation test at 4 months compared with 2 months||||0.75
74076811|NCT03123094|147708269|OTHER||Slope|0.9533|STANDARD_ERROR_OF_MEAN|0.0803|||TWO_SIDED|95.0|0.781|1.1256|||||Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter AUC0-∞, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).||1.1256|0.7810|
73885114|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98||||0.036|TWO_SIDED|95.0|0.06|1.91||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||1.91|0.06|0.036
74076812|NCT03123094|147708270|OTHER||Slope|1.0014|STANDARD_ERROR_OF_MEAN|0.0568|||TWO_SIDED|95.0|0.8809|1.1219|||||Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter Cmax, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).||1.1219|0.8809|
74076813|NCT05342597|147708274|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|1.025|||||TWO_SIDED|90.0|0.931|1.128|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.128|0.931|
74076814|NCT05342597|147708274|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.959|||||TWO_SIDED|90.0|0.871|1.056|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.056|0.871|
74076815|NCT05342597|147708274|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.91|||||TWO_SIDED|90.0|0.827|1.002|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.002|0.827|
74076816|NCT05342597|147708274|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.801|||||TWO_SIDED|90.0|0.712|0.901|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.901|0.712|
74076817|NCT05342597|147708275|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|1.083|||||TWO_SIDED|90.0|0.821|1.429|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.429|0.821|
74076818|NCT05342597|147708275|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.872|||||TWO_SIDED|90.0|0.661|1.15|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.150|0.661|
74076819|NCT05342597|147708275|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.82|||||TWO_SIDED|90.0|0.621|1.082|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.082|0.621|
74076820|NCT05342597|147708275|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.536|||||TWO_SIDED|90.0|0.362|0.794|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.794|0.362|
74076821|NCT03181594|147708299|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||The null hypothesis was that the mean change from baseline for the rTNSS would be 0 (no effect). Assumptions included an alpha level of 0.5 (2-tailed), 90% power, and a standard deviation of 2.5 for the mean change from baseline. A total of 68 participants was deemed adequate to test the hypothesis.||||<0.001
74076822|NCT03181594|147708301|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74076823|NCT03181594|147708302|SUPERIORITY||||||<|0.001||||||p\<0.001 at all time periods. p\<0.05 was considered statistically significant.|Wilcoxon signed rank|||||||<0.001
74076824|NCT01593852|147708310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74076825|NCT01593852|147708318|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
74076826|NCT03769025|147708321|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||.1
74076827|NCT03769025|147708322|SUPERIORITY|||||||0.959|||||||t-test, 2 sided|||||||.959
74076828|NCT03482882|147708334|OTHER||LSM|-10.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-12.0|-9.5|||Mixed-effect model repeated measures|||||-9.5|-12.0|<0.0001
74076829|NCT01754597|147708424|SUPERIORITY|||||||0.714|||||||Wilcoxon (Mann-Whitney)|||||||0.714
74076830|NCT01754597|147708425|SUPERIORITY|||||||0.492|||||||Wilcoxon (Mann-Whitney)|||||||0.492
74076831|NCT01754597|147708426|SUPERIORITY|||||||0.183|||||||Wilcoxon (Mann-Whitney)|||||||0.183
74076832|NCT01588236|147708427|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|95.0||||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo|Mixed Models Analysis|||||||>0.05
73888377|NCT00684021|147309598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|3.7||0.831|TWO_SIDED|95.0|-6.6|8.2|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||8.2|-6.6|0.831
74076833|NCT01588236|147708428|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo||||>0.05
74076834|NCT01588236|147708429|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0||||p value for comparison between overall drug group vs placebo, and between high dose vs placebo|Mixed Models Analysis|||||||<0.01
74076835|NCT01588236|147708430|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||p value for comparison between overall drug group vs placebo, and between low dose vs placebo|Mixed Models Analysis|||||||<0.05
74076836|NCT02115347|147708465|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|87.31|||||TWO_SIDED|90.0|68.01|112.08|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||112.08|68.01|
74076837|NCT02115347|147708466|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|87.43|||||TWO_SIDED|90.0|68.11|112.22|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||112.22|68.11|
74076838|NCT02115347|147708467|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|95.81|||||TWO_SIDED|90.0|72.4|126.79|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||126.79|72.40|
74076839|NCT02115347|147708468|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|95.92|||||TWO_SIDED|90.0|72.46|126.97|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||126.97|72.46|
74076840|NCT02115347|147708469|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|78.7|||||TWO_SIDED|90.0|65.74|94.23|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||94.23|65.74|
74076841|NCT02115347|147708470|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|86.52|||||TWO_SIDED|90.0|70.49|106.2|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||106.20|70.49|
74076842|NCT01175018|147708474|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
74076843|NCT01175018|147708475|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
74076844|NCT01175018|147708476|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
74076845|NCT01175018|147708477|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
74076846|NCT01175018|147708478|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Log Rank|||||||<0.05
74076847|NCT01175018|147708479|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
74076848|NCT01175018|147708480|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
74076849|NCT01175018|147708481|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
74076850|NCT01175018|147708482|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
74076851|NCT01175018|147708483|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
74076852|NCT01175018|147708484|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
74076853|NCT01175018|147708485|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
74076854|NCT01175018|147708486|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
74076855|NCT01175018|147708487|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
74076856|NCT01175018|147708488|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
74076857|NCT01175018|147708489|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
74076858|NCT02964039|147708505|SUPERIORITY|||||||0.047||||||A priori threshold: 0.05|ANOVA|0.047 is the main effect of group from a 2-way ANOVA that also included time (p=0.77) as a within-subjects factor.||||||0.047
74076859|NCT02964039|147708506|SUPERIORITY|||||||0.16||||||A priori threshold: 0.05|ANOVA|0.16 is the main effect of group from a 2-way ANOVA that also included time (p=0.023) as a within-subjects factor.||||||0.16
74076860|NCT02964039|147708507|SUPERIORITY|||||||0.64||||||A priori threshold: 0.05|ANOVA|0.64 is the main effect of group from a 2-way ANOVA that also included time (p=0.024) as a within-subjects factor.||||||0.64
74076861|NCT02964039|147708508|SUPERIORITY|||||||0.92||||||A priori threshold: 0.92|ANOVA|0.92 is the main effect of group from a 2-way ANOVA that also included time (p=0.076) as a within-subjects factor.||||||0.92
74076862|NCT02964039|147708509|SUPERIORITY||||||>=|0.22||||||A priori threshold: 0.05|Mixed Models Analysis|We compared incident rates assuming a negative binomial distribution with leas squares means estimates predicted via generalized linear model.||||||>=0.22
74076863|NCT02964039|147708510|SUPERIORITY|||||||0.99||||||A priori threshold: 0.05|Chi-squared|||||||0.99
74076864|NCT00185458|147708514|SUPERIORITY_OR_OTHER|||||||0.128||95.0|||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.||||0.128
74076865|NCT00185458|147708515|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.||||0.296
74076866|NCT00185458|147708517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
74076867|NCT00185458|147708519|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.027
74076868|NCT00185458|147708520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
74076869|NCT00185458|147708521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
74076870|NCT00185458|147708522|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
74076871|NCT00185458|147708523|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.054
74076872|NCT00185458|147708524|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
74076873|NCT00185458|147708525|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
74076874|NCT00185458|147708526|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
74076875|NCT00185458|147708527|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
74076876|NCT00185458|147708528|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
74076877|NCT00185458|147708529|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
74076878|NCT00185458|147708530|SUPERIORITY_OR_OTHER|||||||0.175||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.175
74076879|NCT00185458|147708531|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.062
74076880|NCT00185458|147708532|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
74076881|NCT00835536|147708557|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|93.1|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108|93.1|
74076882|NCT00835536|147708558|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.5||||||90.0|92.1|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|92.1|
74076883|NCT01141374|147708559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0667|STANDARD_DEVIATION|17.28||0.352|TWO_SIDED|95.0|-76.0|23.0||The test of hypothesis was conducted with repeated measures ANOVA with Post hoc. It was performed parametric test to compare data and the statistical significance was p\<0.05.|ANOVA|||Null hypothesis: there was no statistical difference among 3 groups (control, needles and seeds) after 4 auriculotherapy sessions.||23.00|-76.00|0.352
74076884|NCT01141374|147708560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9067|STANDARD_DEVIATION|19.21||0.023|TWO_SIDED|95.0|-67.0|37.0||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|As for the comparison between the scores, we used ANOVA for repeated measures.It was made post hoc to find the differences among groups.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days and 8 sessions). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||37.00|-67.00|0.023
74076885|NCT03134222|147708616|SUPERIORITY|||||||0.75|||||||Mixed-effect repeated measures model|||||||0.7500
74076886|NCT03134222|147708616|SUPERIORITY|||||||0.3047|||||||Mixed-effect repeated measures model|||||||0.3047
74076887|NCT03134222|147708617|SUPERIORITY|||||||0.8869|||||||Cochran-Mantel-Haenszel|||||||0.8869
74076888|NCT03134222|147708617|SUPERIORITY|||||||0.3293|||||||Cochran-Mantel-Haenszel|||||||0.3293
74076889|NCT03134222|147708618|SUPERIORITY|||||||0.7456|||||||Cochran-Mantel-Haenszel|||||||0.7456
74076890|NCT03134222|147708618|SUPERIORITY|||||||0.6407|||||||Cochran-Mantel-Haenszel|||||||0.6407
74076891|NCT03134222|147708619|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
74076892|NCT03134222|147708619|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
74076893|NCT03134222|147708620|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
74076894|NCT03134222|147708620|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
74076895|NCT00913627|147708629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.16|||<|0.001|TWO_SIDED|95.0|12.13|20.19||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||20.19|12.13|<0.001
73885115|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.65|||<|0.001|TWO_SIDED|95.0|0.68|2.61||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||2.61|0.68|<0.001
73885116|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.178|TWO_SIDED|95.0|-0.3|1.63||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||1.63|-0.30|0.178
73885117|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.093|TWO_SIDED|95.0|-0.14|1.75||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 8.||1.75|-0.14|0.093
73885118|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.003|TWO_SIDED|95.0|0.53|2.51||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||2.51|0.53|0.003
73885119|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.157|TWO_SIDED|95.0|-0.28|1.71||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.71|-0.28|0.157
74076896|NCT00913627|147708629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|||<|0.001|TWO_SIDED|95.0|13.02|20.99||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||20.99|13.02|<0.001
73888378|NCT00684021|147309599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|3.7||0.817|TWO_SIDED|95.0|-5.5|7.0|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||7.0|-5.5|0.817
74076897|NCT00913627|147708629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|||<|0.001|TWO_SIDED|95.0|8.33|16.26||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||16.26|8.33|<0.001
74076898|NCT00913627|147708630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.34|||<|0.001|TWO_SIDED|95.0|4.3|8.38||p-value adjusted for baseline PSR and gender|ANOVA|||||8.38|4.30|<0.001
74076899|NCT00913627|147708630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.06|||<|0.001|TWO_SIDED|95.0|5.05|9.08||p-value adjusted for baseline PSR and gender|ANOVA|||||9.08|5.05|<0.001
74076900|NCT00913627|147708630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.05|||<|0.001|TWO_SIDED|95.0|3.04|7.06||p-value adjusted for baseline PSR and gender|ANOVA|||||7.06|3.04|<0.001
74076901|NCT00913627|147708633|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|TWO_SIDED|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-55.83|-88.56|<0.001
74076902|NCT00913627|147708633|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-54.30|-87.14|<0.001
73885120|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.063|TWO_SIDED|95.0|-0.05|1.82||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||1.82|-0.05|0.063
73885121|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|0.7|2.66||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||2.66|0.70|<0.001
73885122|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.114|TWO_SIDED|95.0|-0.19|1.77||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||1.77|-0.19|0.114
73885123|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51||||0.295|TWO_SIDED|95.0|-0.44|1.46||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||1.46|-0.44|0.295
73885124|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44||||0.005|TWO_SIDED|95.0|0.45|2.44||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||2.44|0.45|0.005
73885125|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.066|TWO_SIDED|95.0|-0.06|1.94||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||1.94|-0.06|0.066
73885126|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.208|TWO_SIDED|95.0|-0.35|1.58||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||1.58|-0.35|0.208
73885127|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.004|TWO_SIDED|95.0|0.49|2.51||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||2.51|0.49|0.004
73885128|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.086|TWO_SIDED|95.0|-0.13|1.89||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||1.89|-0.13|0.086
74076903|NCT00913627|147708633|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-59.6|||<|0.001|TWO_SIDED|95.0|-76.94|-42.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-42.27|-76.94|<0.001
74076904|NCT00913627|147708633|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|TWO_SIDED|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-55.83|-88.56|<0.001
74076905|NCT00913627|147708633|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-54.30|-87.14|<0.001
73885129|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.328|TWO_SIDED|95.0|-0.49|1.45||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||1.45|-0.49|0.328
73885130|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.005|TWO_SIDED|95.0|0.44|2.47||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||2.47|0.44|0.005
73885131|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98||||0.059|TWO_SIDED|95.0|-0.04|1.99||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||1.99|-0.04|0.059
73885132|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.117|TWO_SIDED|95.0|-0.09|0.79||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.79|-0.09|0.117
73885133|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.412|TWO_SIDED|95.0|-0.25|0.62||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.62|-0.25|0.412
73885134|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.445|TWO_SIDED|95.0|-0.6|0.26||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.26|-0.60|0.445
74076906|NCT00913627|147708633|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-57.79|||<|0.001|TWO_SIDED|95.0|-75.43|-40.16||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-40.16|-75.43|<0.001
74076907|NCT00913627|147708633|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-66.79|||<|0.001|TWO_SIDED|95.0|-83.98|-49.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-49.60|-83.98|<0.001
73885135|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.025|TWO_SIDED|95.0|0.07|1.09||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||1.09|0.07|0.025
73885136|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.257|TWO_SIDED|95.0|-0.21|0.79||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||0.79|-0.21|0.257
73888379|NCT00684021|147309600|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|4.27||0.272|TWO_SIDED|95.0|-13.7|3.67|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||3.67|-13.7|0.272
74076908|NCT00913627|147708633|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-54.30|-87.14|<0.001
74076909|NCT00913627|147708633|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-55.98|||<|0.001|TWO_SIDED|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-38.11|-73.85|<0.001
74076910|NCT00913627|147708633|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-63.44|||<|0.001|TWO_SIDED|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-46.06|-80.82|<0.001
74076911|NCT00913627|147708633|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-68.88|||<|0.001|TWO_SIDED|95.0|-85.63|-54.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-54.14|-85.63|<0.001
73885137|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.257|TWO_SIDED|95.0|-0.79|0.21||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||0.21|-0.79|0.257
73885138|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.075|TWO_SIDED|95.0|-0.05|1.04||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||1.04|-0.05|0.075
73885139|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.634|TWO_SIDED|95.0|-0.42|0.68||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||0.68|-0.42|0.634
73885140|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.193|TWO_SIDED|95.0|-0.91|0.19||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||0.19|-0.91|0.193
73885141|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.688|TWO_SIDED|95.0|-0.46|0.7||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.70|-0.46|0.688
73885142|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.944|TWO_SIDED|95.0|-0.6|0.56||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.56|-0.60|0.944
73885143|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.64|TWO_SIDED|95.0|-0.73|0.45||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.45|-0.73|0.640
73885144|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.439|TWO_SIDED|95.0|-0.37|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.84|-0.37|0.439
74076912|NCT00913627|147708633|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-55.98|||<|0.001|TWO_SIDED|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-38.11|-73.85|<0.001
74076913|NCT00913627|147708633|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-63.44|||<|0.001|TWO_SIDED|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-46.06|-80.82|<0.001
74076914|NCT00913627|147708633|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-65.28|||<|0.001|TWO_SIDED|95.0|-82.49|-48.07||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-48.07|-82.49|<0.001
73885145|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.461|TWO_SIDED|95.0|-0.38|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.84|-0.38|0.461
73885146|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.976|TWO_SIDED|95.0|-0.62|0.6||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.60|-0.62|0.976
73885147|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.829|TWO_SIDED|95.0|-0.55|0.68||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.68|-0.55|0.829
73885148|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.713|TWO_SIDED|95.0|-0.5|0.74||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.74|-0.50|0.713
73885149|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.878|TWO_SIDED|95.0|-0.58|0.67||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.67|-0.58|0.878
73885150|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.447|TWO_SIDED|95.0|-0.38|0.85||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.85|-0.38|0.447
73885151|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.511|TWO_SIDED|95.0|-0.41|0.83||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.83|-0.41|0.511
73885152|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.924|TWO_SIDED|95.0|-0.65|0.59||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.59|-0.65|0.924
73888380|NCT00684021|147309601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.1||0.409|TWO_SIDED|95.0|-3.0|1.2|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||1.2|-3.0|0.409
74076915|NCT00913627|147708633|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-50.77|||<|0.001|TWO_SIDED|95.0|-69.09|-32.45||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-32.45|-69.09|<0.001
73888381|NCT00684021|147309601|SUPERIORITY_OR_OTHER||Mean Difference (Net)|100.0|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|15.0|1000.0|||Regression, Linear|||||1000|15|0.02
74076916|NCT00913627|147708634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.34|||<|0.001|TWO_SIDED|95.0|4.18|6.51||p-value adjusted for baseline PSR, and gender|ANOVA|||SPID 0-4||6.51|4.18|<0.001
74076917|NCT00913627|147708634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.25|||<|0.001|TWO_SIDED|95.0|4.09|6.4||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4||6.40|4.09|<0.001
74076918|NCT00913627|147708634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|||<|0.001|TWO_SIDED|95.0|2.83|5.12||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4||5.12|2.83|<0.001
73885153|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.185|TWO_SIDED|95.0|-0.2|1.06||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||1.06|-0.20|0.185
73885154|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.403|TWO_SIDED|95.0|-0.37|0.91||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||0.91|-0.37|0.403
73885155|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.636|TWO_SIDED|95.0|-0.79|0.49||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||0.49|-0.79|0.636
73885156|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.304|TWO_SIDED|95.0|-0.3|0.95||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.95|-0.30|0.304
73885157|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.295|TWO_SIDED|95.0|-0.29|0.97||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.97|-0.29|0.295
73885158|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.975|TWO_SIDED|95.0|-0.62|0.64||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.64|-0.62|0.975
73885159|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.349|TWO_SIDED|95.0|-0.33|0.93||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.93|-0.33|0.349
73888382|NCT00684021|147309602|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.7||0.777|TWO_SIDED|95.0|-3.9|2.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||2.9|-3.9|0.777
74076919|NCT00913627|147708634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.53|||<|0.001|TWO_SIDED|95.0|5.63|9.43||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||9.43|5.63|<0.001
74076920|NCT00913627|147708634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.68|||<|0.001|TWO_SIDED|95.0|5.8|9.56||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||9.56|5.80|<0.001
73888548|NCT01929317|147309698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.8|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, On status.|||0.1|-1.8|
74076921|NCT00913627|147708634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49|||<|0.001|TWO_SIDED|95.0|3.62|7.36||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||7.36|3.62|<0.001
74076922|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.47|||<|0.001|TWO_SIDED|95.0|10.68|16.27||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||16.27|10.68|<0.001
74076923|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.24|||<|0.001|TWO_SIDED|95.0|10.48|16.01||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||16.01|10.48|<0.001
74076924|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.08|||<|0.001|TWO_SIDED|95.0|7.33|12.83||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||12.83|7.33|<0.001
73885160|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.351|TWO_SIDED|95.0|-0.34|0.94||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.94|-0.34|0.351
73885161|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.64|0.65||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.65|-0.64|0.992
73885162|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.681|TWO_SIDED|95.0|-0.5|0.77||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.77|-0.50|0.681
73885163|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.569|TWO_SIDED|95.0|-0.46|0.83||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.83|-0.46|0.569
73885164|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.871|TWO_SIDED|95.0|-0.6|0.7||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.70|-0.60|0.871
74076925|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.21|||<|0.001|TWO_SIDED|95.0|14.71|23.71||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||23.71|14.71|<0.001
73885165|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.675|TWO_SIDED|95.0|-0.5|0.78||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.78|-0.50|0.675
73885166|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.823|TWO_SIDED|95.0|-0.57|0.72||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.72|-0.57|0.823
73888549|NCT01929317|147309698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-2.4|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, On status.|||0.1|-2.4|
74076926|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.32|||<|0.001|TWO_SIDED|95.0|14.86|23.78||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||23.78|14.86|<0.001
74076927|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.87|||<|0.001|TWO_SIDED|95.0|9.44|18.3||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||18.30|9.44|<0.001
73885167|NCT00385671|147303886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.85|TWO_SIDED|95.0|-0.72|0.59||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.59|-0.72|0.850
73885168|NCT00385671|147303888|SUPERIORITY_OR_OTHER|||||||0.448||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.448
73885169|NCT00385671|147303888|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.118
73885170|NCT00385671|147303888|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.021
73885171|NCT00385671|147303888|SUPERIORITY_OR_OTHER|||||||0.537||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.537
73885172|NCT00385671|147303888|SUPERIORITY_OR_OTHER|||||||0.911||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.911
73885173|NCT00385671|147303888|SUPERIORITY_OR_OTHER|||||||0.627||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.627
73885174|NCT00385671|147303889|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.078
73885175|NCT00385671|147303889|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.130
73885176|NCT00385671|147303889|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.850
74076928|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.18|||<|0.001|TWO_SIDED|95.0|11.29|21.07||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||21.07|11.29|<0.001
74076929|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.65|||<|0.001|TWO_SIDED|95.0|12.81|22.49||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||22.49|12.81|<0.001
74076930|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.78|||<|0.001|TWO_SIDED|95.0|7.97|17.59||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||17.59|7.97|<0.001
74076931|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.08|||<|0.001|TWO_SIDED|95.0|31.48|50.69||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||50.69|31.48|<0.001
73885177|NCT00385671|147303890|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.||||<0.001
73885178|NCT00385671|147303890|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in body weight.||||<0.001
73885179|NCT00385671|147303890|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.||||0.011
73885180|NCT00385671|147303891|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||0.830
73885181|NCT00385671|147303891|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||1.00
73885182|NCT00385671|147303891|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||1.00
73885183|NCT00385671|147303891|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.060
73885184|NCT00385671|147303891|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.502
74076932|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.66|||<|0.001|TWO_SIDED|95.0|33.15|52.17||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||52.17|33.15|<0.001
73885185|NCT00385671|147303891|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.376
74076933|NCT00913627|147708635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.08|||<|0.001|TWO_SIDED|95.0|21.63|40.53||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||40.53|21.63|<0.001
73885186|NCT00385671|147303892|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.281
73885187|NCT00385671|147303892|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.060
73885188|NCT00385671|147303892|SUPERIORITY_OR_OTHER|||||||0.596||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.596
74076934|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.13|||<|0.001|TWO_SIDED|95.0|6.45|9.8||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||9.80|6.45|<0.001
74076935|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|||<|0.001|TWO_SIDED|95.0|6.34|9.65||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||9.65|6.34|<0.001
74076936|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.11|||<|0.001|TWO_SIDED|95.0|4.46|7.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||7.75|4.46|<0.001
74076937|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.68|||<|0.001|TWO_SIDED|95.0|9.02|14.34||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||14.34|9.02|<0.001
74076938|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.64|||<|0.001|TWO_SIDED|95.0|9.01|14.27||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||14.27|9.01|<0.001
73885189|NCT00385671|147303893|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.||||0.332
74076939|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.38|||<|0.001|TWO_SIDED|95.0|5.76|11.0||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||11.00|5.76|<0.001
74076940|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.84|||<|0.001|TWO_SIDED|95.0|6.93|12.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||12.75|6.93|<0.001
74076941|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.59|||<|0.001|TWO_SIDED|95.0|7.71|13.46||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||13.46|7.71|<0.001
74076942|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.73|||<|0.001|TWO_SIDED|95.0|4.87|10.59||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||10.59|4.87|<0.001
74076943|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.93|||<|0.001|TWO_SIDED|95.0|19.24|30.61||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||30.61|19.24|<0.001
74076944|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.66|||<|0.001|TWO_SIDED|95.0|20.03|31.28||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||31.28|20.03|<0.001
74076945|NCT00913627|147708636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.78|||<|0.001|TWO_SIDED|95.0|13.19|24.38||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||24.38|13.19|<0.001
74076946|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.31||||0.08|TWO_SIDED|95.0|1.26|25.36||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||25.36|1.26|0.080
74076947|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|16.39||||0.043|TWO_SIDED|95.0|3.73|29.04||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||29.04|3.73|0.043
74076948|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.39||||0.354|TWO_SIDED|95.0|-4.62|15.4||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||15.40|-4.62|0.354
74076949|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|48.65|||<|0.001|TWO_SIDED|95.0|33.34|63.96||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||63.96|33.34|<0.001
74076950|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.94|||<|0.001|TWO_SIDED|95.0|37.15|66.73||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||66.73|37.15|<0.001
74076951|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|36.8|||<|0.001|TWO_SIDED|95.0|22.62|50.98||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||50.98|22.62|<0.001
74076952|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.39|||<|0.001|TWO_SIDED|95.0|41.2|73.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||73.57|41.20|<0.001
74076953|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|66.67|||<|0.001|TWO_SIDED|95.0|51.56|81.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||81.78|51.56|<0.001
74076954|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.2|||<|0.001|TWO_SIDED|95.0|34.2|66.21||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||66.21|34.20|<0.001
74076955|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|67.64|||<|0.001|TWO_SIDED|95.0|51.36|83.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||83.93|51.36|<0.001
74076956|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|70.61|||<|0.001|TWO_SIDED|95.0|55.16|86.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||86.05|55.16|<0.001
74076957|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.85|||<|0.001|TWO_SIDED|95.0|34.32|69.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||69.38|34.32|<0.001
74076958|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||85.33|53.33|<0.001
74076959|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|74.21|||<|0.001|TWO_SIDED|95.0|59.29|89.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||89.14|59.29|<0.001
74076960|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||75.84|41.88|<0.001
73885190|NCT00385671|147303893|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent high body weight.||||0.065
74076961|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||85.33|53.33|<0.001
74076962|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||92.06|63.57|<0.001
74076963|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||75.84|41.88|<0.001
74076964|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||85.33|53.33|<0.001
73885191|NCT00385671|147303893|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.||||0.622
73885192|NCT00385671|147303893|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.||||0.103
73885193|NCT00385671|147303893|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent low body weight.||||0.034
73885194|NCT00385671|147303893|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.||||0.808
73885195|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.||||0.055
73885196|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AST.||||0.051
73885197|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.993||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.||||0.993
73885198|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.928||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in ALT.||||0.928
74076965|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||92.06|63.57|<0.001
74076966|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||75.84|41.88|<0.001
74076967|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||85.33|53.33|<0.001
74076968|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||92.06|63.57|<0.001
74076969|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||75.84|41.88|<0.001
73885199|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in ALT.||||0.609
73885200|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in ALT.||||0.675
73885201|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in GGT.||||0.985
73888383|NCT02900378|147309610|OTHER||Differences of least square means|5.68|STANDARD_ERROR_OF_MEAN|4.89||0.2464|TWO_SIDED|95.0|-3.93|15.29||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS)||15.29|-3.93|0.2464
73885202|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.847||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in GGT.||||0.847
73885203|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in GGT.||||0.832
73885204|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.||||0.169
73885205|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AlkPhos.||||0.910
73885206|NCT00385671|147303894|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.||||0.134
73885207|NCT00385671|147303895|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 total bilirubin.||||0.285
74076970|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||85.33|53.33|<0.001
74076971|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||92.06|63.57|<0.001
74076972|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||75.84|41.88|<0.001
74076973|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||85.33|53.33|<0.001
74076974|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||92.06|63.57|<0.001
74076975|NCT00913627|147708637|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||75.84|41.88|<0.001
74076976|NCT00913627|147708638|SUPERIORITY_OR_OTHER||Hazard Ratio, log|13.56|||<|0.001|TWO_SIDED|95.0|4.85|37.89||p-value adjusted for gender and categorical baseline pain severity|Proportional hazards regression|||||37.89|4.85|<0.001
73885208|NCT00385671|147303895|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in total bilirubin.||||0.505
73885209|NCT00385671|147303895|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in total bilirubin.||||0.679
74076977|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|2.03||||0.434|TWO_SIDED|95.0|-1.95|6.02||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||6.02|-1.95|0.434
74076978|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Cochran-Mantel-Haenszel|||15 minutes||0.00|0.00|
74076979|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.78||||0.469|TWO_SIDED|95.0|-1.71|5.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||5.27|-1.71|0.469
74076980|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.13||||0.101|TWO_SIDED|95.0|1.33|16.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||16.93|1.33|0.101
73885210|NCT00385671|147303896|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.047
74076981|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.73||||0.069|TWO_SIDED|95.0|2.54|18.91||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||18.91|2.54|0.069
74076982|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|3.59||||0.303|TWO_SIDED|95.0|-1.39|8.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||8.57|-1.39|0.303
74076983|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|24.58||||0.008|TWO_SIDED|95.0|10.68|38.47||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||38.47|10.68|0.008
74076984|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|25.31||||0.007|TWO_SIDED|95.0|11.35|39.28||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||39.28|11.35|0.007
74076985|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.62||||0.129|TWO_SIDED|95.0|-0.68|21.92||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||21.92|-0.68|0.129
74076986|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|47.72|||<|0.001|TWO_SIDED|95.0|32.25|63.19||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||63.19|32.25|<0.001
74076987|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|36.01|||<|0.001|TWO_SIDED|95.0|21.24|50.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||50.78|21.24|<0.001
74076988|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|27.87||||0.003|TWO_SIDED|95.0|13.93|41.81||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||41.81|13.93|0.003
74076989|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|61.01|||<|0.001|TWO_SIDED|95.0|46.12|75.89||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||75.89|46.12|<0.001
74076990|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.83|||<|0.001|TWO_SIDED|95.0|38.85|68.8||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||68.80|38.85|<0.001
74076991|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|31.89|61.58||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||61.58|31.89|<0.001
73885211|NCT00385671|147303896|SUPERIORITY_OR_OTHER|||||||0.232||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.232
74076992|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|64.78|||<|0.001|TWO_SIDED|95.0|49.37|80.18||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||80.18|49.37|<0.001
74076993|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|64.8|||<|0.001|TWO_SIDED|95.0|50.01|79.59||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||79.59|50.01|<0.001
74076994|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.19|||<|0.001|TWO_SIDED|95.0|34.27|66.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||66.11|34.27|<0.001
74076995|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|68.59|||<|0.001|TWO_SIDED|95.0|52.81|84.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||84.38|52.81|<0.001
74076996|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.16|||<|0.001|TWO_SIDED|95.0|57.05|87.26||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||87.26|57.05|<0.001
74076997|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.47|||<|0.001|TWO_SIDED|95.0|36.57|70.37||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||70.37|36.57|<0.001
74076998|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.66|||<|0.001|TWO_SIDED|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||87.84|57.48|<0.001
74076999|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|79.36|||<|0.001|TWO_SIDED|95.0|65.68|93.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||93.05|65.68|<0.001
74077000|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.03|||<|0.001|TWO_SIDED|95.0|40.46|73.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||73.60|40.46|<0.001
74077001|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.66|||<|0.001|TWO_SIDED|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||87.84|57.48|<0.001
74077002|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|81.2|||<|0.001|TWO_SIDED|95.0|67.91|94.49||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||94.49|67.91|<0.001
74077003|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.84|||<|0.001|TWO_SIDED|95.0|42.34|75.35||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||75.35|42.34|<0.001
74077004|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||85.33|53.33|<0.001
74077005|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||92.06|63.57|<0.001
74077006|NCT00913627|147708639|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||75.84|41.88|<0.001
74077007|NCT00913627|147708640|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|TWO_SIDED|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.85|<0.001
74077008|NCT00913627|147708640|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.95|||<|0.001|TWO_SIDED|95.0|0.88|1.02||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.02|0.88|<0.001
74077009|NCT00913627|147708640|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.84|||<|0.001|TWO_SIDED|95.0|0.7|0.98||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||0.98|0.70|<0.001
74077010|NCT00913627|147708641|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|TWO_SIDED|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.85|<0.001
74077011|NCT00913627|147708641|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.96|||<|0.001|TWO_SIDED|95.0|0.91|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.91|<0.001
74077012|NCT00913627|147708641|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.89|||<|0.001|TWO_SIDED|95.0|0.79|0.99||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||0.99|0.79|<0.001
74077013|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.38|0.06|0.008
74077014|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.007|TWO_SIDED|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.38|0.06|0.007
74077015|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.024|TWO_SIDED|95.0|0.02|0.34||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.34|0.02|0.024
74077016|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|||<|0.001|TWO_SIDED|95.0|0.24|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.78|0.24|<0.001
74077017|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||<|0.001|TWO_SIDED|95.0|0.2|0.73||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.73|0.20|<0.001
74077018|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.002|TWO_SIDED|95.0|0.16|0.68||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.68|0.16|0.002
74077019|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||<|0.001|TWO_SIDED|95.0|0.52|1.17||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.17|0.52|<0.001
74077020|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|||<|0.001|TWO_SIDED|95.0|0.47|1.11||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.11|0.47|<0.001
74077021|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|||<|0.001|TWO_SIDED|95.0|0.3|0.94||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||0.94|0.30|<0.001
74077022|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.65|1.37||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.37|0.65|<0.001
74077023|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|||<|0.001|TWO_SIDED|95.0|0.73|1.44||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.44|0.73|<0.001
74077024|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.54|1.25||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.25|0.54|<0.001
74077025|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||<|0.001|TWO_SIDED|95.0|0.9|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.63|0.90|<0.001
74077026|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33|||<|0.001|TWO_SIDED|95.0|0.97|1.69||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.69|0.97|<0.001
74077027|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.74|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.45|0.74|<0.001
74077028|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45|||<|0.001|TWO_SIDED|95.0|1.09|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.82|1.09|<0.001
74077029|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.82|1.10|<0.001
73885212|NCT00385671|147303896|SUPERIORITY_OR_OTHER|||||||0.424||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.424
73885213|NCT00385671|147303897|SUPERIORITY_OR_OTHER|||||||0.298||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.298
73885214|NCT00385671|147303897|SUPERIORITY_OR_OTHER|||||||0.987||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.987
73885215|NCT00385671|147303897|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.297
73885216|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.||||1.00
73885217|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AST values.||||0.749
73885218|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.||||0.750
73885219|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.050
73885220|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.320
74077030|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.67|1.38||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.38|0.67|<0.001
73885221|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.440
73885222|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated TBili values.||||0.498
73885223|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.245||95.0||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated TBili values.||||0.245
73885224|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.||||0.160
73885225|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated GGT values.||||0.280
74077031|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.26|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.00|1.26|<0.001
73885226|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.||||1.00
73885227|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.023
73885228|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.264
73885229|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.325
73885230|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||1.00
73885231|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||0.121
74077032|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|||<|0.001|TWO_SIDED|95.0|1.25|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||1.98|1.25|<0.001
74077033|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.85|1.57||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||1.57|0.85|<0.001
74077034|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71|||<|0.001|TWO_SIDED|95.0|1.33|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.08|1.33|<0.001
74077035|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|1.23|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||1.97|1.23|<0.001
74077036|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|||<|0.001|TWO_SIDED|95.0|0.81|1.54||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||1.54|0.81|<0.001
74077037|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.00|1.20|<0.001
73885232|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||0.095
73885233|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||1.00
73885234|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||0.720
73885235|NCT00385671|147303898|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||0.722
74077038|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|||<|0.001|TWO_SIDED|95.0|1.19|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||1.98|1.19|<0.001
74077039|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.73|1.52||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||1.52|0.73|<0.001
74077040|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|||<|0.001|TWO_SIDED|95.0|1.08|1.9||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.90|1.08|<0.001
74077041|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||<|0.001|TWO_SIDED|95.0|1.16|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.97|1.16|<0.001
74077042|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13|||<|0.001|TWO_SIDED|95.0|0.72|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.53|0.72|<0.001
73885236|NCT00303069|147303900|SUPERIORITY_OR_OTHER||Risk Difference (RD)|84.5|||<|0.001|TWO_SIDED|95.0|65.2|93.6||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||93.6|65.2|<0.001
73885237|NCT00303069|147303900|SUPERIORITY_OR_OTHER||Risk Difference (RD)|81.6|||<|0.01|TWO_SIDED|95.0|61.6|92.0||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||92.0|61.6|<0.01
73888384|NCT02900378|147309610|OTHER||Differences of least square means|8.98|STANDARD_ERROR_OF_MEAN|4.58||0.0503|TWO_SIDED|97.5|-1.31|19.27||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without AE/SAE)||19.27|-1.31|0.0503
74077043|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||<|0.001|TWO_SIDED|95.0|0.97|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.79|0.97|<0.001
74077044|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.55|||<|0.001|TWO_SIDED|95.0|1.14|1.95||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.95|1.14|<0.001
74077045|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|||<|0.001|TWO_SIDED|95.0|0.62|1.43||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.43|0.62|<0.001
74077046|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||<|0.001|TWO_SIDED|95.0|0.93|1.77||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.77|0.93|<0.001
74077047|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.81|0.97|<0.001
74077048|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.001|TWO_SIDED|95.0|0.63|1.46||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.46|0.63|<0.001
74077049|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|||<|0.001|TWO_SIDED|95.0|0.87|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.71|0.87|<0.001
74077050|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.81|0.97|<0.001
74077051|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|||<|0.001|TWO_SIDED|95.0|0.56|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.39|0.56|<0.001
74077052|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.82|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.68|0.82|<0.001
74077053|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|||<|0.001|TWO_SIDED|95.0|1.03|1.89||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.89|1.03|<0.001
74077054|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.6|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.45|0.60|<0.001
74077055|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.77|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.64|0.77|<0.001
74077056|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.001|TWO_SIDED|95.0|1.0|1.87||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.87|1.00|<0.001
74077057|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.001|TWO_SIDED|95.0|0.61|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.48|0.61|<0.001
74077058|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.81|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.68|0.81|<0.001
74077059|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.96|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.82|0.96|<0.001
74077060|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||<|0.001|TWO_SIDED|95.0|0.53|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.39|0.53|<0.001
74077061|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|0.75|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.64|0.75|<0.001
74077062|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.77|1.65||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.65|0.77|<0.001
74077063|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|||<|0.001|TWO_SIDED|95.0|0.49|1.36||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.36|0.49|<0.001
74077064|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|||<|0.001|TWO_SIDED|95.0|0.6|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.53|0.60|<0.001
74077065|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.66|1.58||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.58|0.66|<0.001
74077066|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.001|TWO_SIDED|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.33|0.42|<0.001
74077067|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|||<|0.001|TWO_SIDED|95.0|0.61|1.51||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.51|0.61|<0.001
74077068|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.58|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.48|0.58|<0.001
74077069|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||<|0.001|TWO_SIDED|95.0|0.52|1.4||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.40|0.52|<0.001
74077070|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.001|TWO_SIDED|95.0|0.31|1.24||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.24|0.31|0.001
74077071|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.001|TWO_SIDED|95.0|0.36|1.28||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.28|0.36|<0.001
74077072|NCT00913627|147708642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88|||<|0.001|TWO_SIDED|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.33|0.42|<0.001
74077073|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.034|TWO_SIDED|95.0|0.02|0.57||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.57|0.02|0.034
74077074|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.111|TWO_SIDED|95.0|-0.05|0.49||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.49|-0.05|0.111
74077075|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.125|TWO_SIDED|95.0|-0.06|0.48||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.48|-0.06|0.125
74077076|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|||<|0.001|TWO_SIDED|95.0|0.41|1.22||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.22|0.41|<0.001
74077077|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.003|TWO_SIDED|95.0|0.22|1.01||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.01|0.22|0.003
74077078|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.004|TWO_SIDED|95.0|0.19|0.98||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.98|0.19|0.004
74077079|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.41|||<|0.001|TWO_SIDED|95.0|0.91|1.91||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.91|0.91|<0.001
74077080|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|||<|0.001|TWO_SIDED|95.0|0.75|1.74||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.74|0.75|<0.001
74077081|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.41|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.39|0.41|<0.001
74077082|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.11|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||2.16|1.11|<0.001
74077083|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.57|||<|0.001|TWO_SIDED|95.0|1.05|2.09||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||2.09|1.05|<0.001
74077084|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||<|0.001|TWO_SIDED|95.0|0.75|1.78||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.78|0.75|<0.001
74077085|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99|||<|0.001|TWO_SIDED|95.0|1.46|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.52|1.46|<0.001
74077086|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|||<|0.001|TWO_SIDED|95.0|1.57|2.61||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.61|1.57|<0.001
74077087|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|1.16|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.20|1.16|<0.001
74077088|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.59|2.64||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.64|1.59|<0.001
74077089|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.7|2.74||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.74|1.70|<0.001
74077090|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|||<|0.001|TWO_SIDED|95.0|1.18|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.21|1.18|<0.001
74077091|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED|95.0|1.98|3.01||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||3.01|1.98|<0.001
74077092|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||<|0.001|TWO_SIDED|95.0|1.97|2.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.99|1.97|<0.001
74077093|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88|||<|0.001|TWO_SIDED|95.0|1.37|2.38||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.38|1.37|<0.001
74077094|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.54|||<|0.001|TWO_SIDED|95.0|2.01|3.07||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||3.07|2.01|<0.001
74077095|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45|||<|0.001|TWO_SIDED|95.0|1.92|2.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.97|1.92|<0.001
74077096|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|||<|0.001|TWO_SIDED|95.0|1.29|2.33||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.33|1.29|<0.001
74077097|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47|||<|0.001|TWO_SIDED|95.0|1.92|3.03||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||3.03|1.92|<0.001
74077098|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41|||<|0.001|TWO_SIDED|95.0|1.87|2.96||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.96|1.87|<0.001
74077099|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71|||<|0.001|TWO_SIDED|95.0|1.16|2.25||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.25|1.16|<0.001
74077100|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.69|2.83||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.83|1.69|<0.001
74077101|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37|||<|0.001|TWO_SIDED|95.0|1.8|2.93||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.93|1.80|<0.001
74077102|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|||<|0.001|TWO_SIDED|95.0|1.11|2.23||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.23|1.11|<0.001
74077103|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.66|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.79|1.66|<0.001
74077104|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.74|2.85||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.85|1.74|<0.001
74077105|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.57|||<|0.001|TWO_SIDED|95.0|1.02|2.13||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.13|1.02|<0.001
74077106|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.59|2.78||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.78|1.59|<0.001
74077107|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.53|2.7||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.70|1.53|<0.001
74077108|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.04|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.21|1.04|<0.001
74077109|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91|||<|0.001|TWO_SIDED|95.0|1.3|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.52|1.30|<0.001
74077110|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.52|2.72||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.72|1.52|<0.001
74077111|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|||<|0.001|TWO_SIDED|95.0|0.91|2.11||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.11|0.91|<0.001
74077112|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|||<|0.001|TWO_SIDED|95.0|1.34|2.55||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.55|1.34|<0.001
74077113|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.59|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.79|1.59|<0.001
74077114|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||<|0.001|TWO_SIDED|95.0|0.97|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.16|0.97|<0.001
74077115|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.28|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.52|1.28|<0.001
74077116|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|||<|0.001|TWO_SIDED|95.0|1.52|2.75||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.75|1.52|<0.001
74077117|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|||<|0.001|TWO_SIDED|95.0|0.98|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.20|0.98|<0.001
74077118|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.26|2.54||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.54|1.26|<0.001
74077119|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|||<|0.001|TWO_SIDED|95.0|1.39|2.66||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.66|1.39|<0.001
74077120|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.001|TWO_SIDED|95.0|0.81|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.07|0.81|<0.001
74077121|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.83|||<|0.001|TWO_SIDED|95.0|1.17|2.49||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.49|1.17|<0.001
74077122|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78|||<|0.001|TWO_SIDED|95.0|1.13|2.43||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.43|1.13|<0.001
74077123|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42|||<|0.001|TWO_SIDED|95.0|0.78|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.07|0.78|<0.001
74077124|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|||<|0.001|TWO_SIDED|95.0|0.95|2.32||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.32|0.95|<0.001
74077125|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|||<|0.001|TWO_SIDED|95.0|0.94|2.29||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.29|0.94|<0.001
74077126|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||<|0.001|TWO_SIDED|95.0|0.71|2.06||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.06|0.71|<0.001
74077127|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|||<|0.001|TWO_SIDED|95.0|0.88|2.27||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.27|0.88|<0.001
74077128|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42|||<|0.001|TWO_SIDED|95.0|0.73|2.1||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.10|0.73|<0.001
74077129|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||<|0.001|TWO_SIDED|95.0|0.72|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.08|0.72|<0.001
73888550|NCT01929317|147309698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-2.6|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, On status.|||0.3|-2.6|
73885238|NCT00303069|147303900|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.0|||<|0.001|TWO_SIDED|95.0|6.7|43.8||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||43.8|6.7|<0.001
74077130|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.53|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.96|0.53|<0.001
74077131|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08||||0.003|TWO_SIDED|95.0|0.38|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.79|0.38|0.003
74077132|NCT00913627|147708643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||<|0.001|TWO_SIDED|95.0|0.61|2.02||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||2.02|0.61|<0.001
74077133|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.011|TWO_SIDED|95.0|0.12|0.91||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.91|0.12|0.011
74077134|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.028|TWO_SIDED|95.0|0.05|0.83||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.83|0.05|0.028
74077135|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.048|TWO_SIDED|95.0|0.0|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.78|0.00|0.048
74077136|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||<|0.001|TWO_SIDED|95.0|0.69|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.96|0.69|<0.001
74077137|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.45|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.71|0.45|<0.001
74077138|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.002|TWO_SIDED|95.0|0.38|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.63|0.38|0.002
74077139|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.46|3.06||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||3.06|1.46|<0.001
74077140|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|||<|0.001|TWO_SIDED|95.0|1.24|2.82||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||2.82|1.24|<0.001
74077141|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED|95.0|0.74|2.31||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||2.31|0.74|<0.001
74077142|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.78|3.5||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.50|1.78|<0.001
74077143|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66|||<|0.001|TWO_SIDED|95.0|1.81|3.51||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.51|1.81|<0.001
74077144|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16|||<|0.001|TWO_SIDED|95.0|1.32|3.0||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.00|1.32|<0.001
74077145|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|||<|0.001|TWO_SIDED|95.0|2.39|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||4.12|2.39|<0.001
74077146|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.42|||<|0.001|TWO_SIDED|95.0|2.57|4.28||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||4.28|2.57|<0.001
74077147|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.77|||<|0.001|TWO_SIDED|95.0|1.92|3.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||3.63|1.92|<0.001
74077148|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.7|4.44||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||4.44|2.70|<0.001
74077149|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|||<|0.001|TWO_SIDED|95.0|2.82|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||4.53|2.82|<0.001
74077150|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|||<|0.001|TWO_SIDED|95.0|1.87|3.57||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||3.57|1.87|<0.001
74077151|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.13|||<|0.001|TWO_SIDED|95.0|3.27|4.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||4.99|3.27|<0.001
74077152|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|||<|0.001|TWO_SIDED|95.0|3.24|4.95||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||4.95|3.24|<0.001
74077153|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||<|0.001|TWO_SIDED|95.0|2.24|3.93||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||3.93|2.24|<0.001
74077154|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.25|||<|0.001|TWO_SIDED|95.0|3.36|5.13||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||5.13|3.36|<0.001
74077155|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.04|||<|0.001|TWO_SIDED|95.0|3.17|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||4.92|3.17|<0.001
74077156|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|||<|0.001|TWO_SIDED|95.0|2.11|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||3.85|2.11|<0.001
74077157|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.07|||<|0.001|TWO_SIDED|95.0|3.14|5.01||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||5.01|3.14|<0.001
74077158|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|||<|0.001|TWO_SIDED|95.0|3.07|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||4.92|3.07|<0.001
74077159|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.83|||<|0.001|TWO_SIDED|95.0|1.91|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||3.75|1.91|<0.001
74077160|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|||<|0.001|TWO_SIDED|95.0|2.78|4.71||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||4.71|2.78|<0.001
74077161|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93|||<|0.001|TWO_SIDED|95.0|2.98|4.89||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||4.89|2.98|<0.001
73885239|NCT00303069|147303901|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.9|||<|0.001|TWO_SIDED|95.0|17.2|48.3||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||48.3|17.2|<0.001
74077162|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||<|0.001|TWO_SIDED|95.0|1.85|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||3.75|1.85|<0.001
74077163|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.61|||<|0.001|TWO_SIDED|95.0|2.65|4.56||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||4.56|2.65|<0.001
74077164|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|||<|0.001|TWO_SIDED|95.0|2.89|4.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||4.79|2.89|<0.001
74077165|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|||<|0.001|TWO_SIDED|95.0|1.65|3.54||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||3.54|1.65|<0.001
74077166|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54|||<|0.001|TWO_SIDED|95.0|2.54|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||4.53|2.54|<0.001
74077167|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|||<|0.001|TWO_SIDED|95.0|2.52|4.49||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||4.49|2.52|<0.001
74077168|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|||<|0.001|TWO_SIDED|95.0|1.69|3.65||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||3.65|1.69|<0.001
74077169|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|||<|0.001|TWO_SIDED|95.0|2.19|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||4.21|2.19|<0.001
74077170|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|||<|0.001|TWO_SIDED|95.0|2.51|4.51||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||4.51|2.51|<0.001
74077171|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||<|0.001|TWO_SIDED|95.0|1.49|3.48||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||3.48|1.49|<0.001
74077172|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||<|0.001|TWO_SIDED|95.0|2.17|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||4.21|2.17|<0.001
74077173|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||<|0.001|TWO_SIDED|95.0|2.64|4.66||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||4.66|2.64|<0.001
74077174|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||<|0.001|TWO_SIDED|95.0|1.58|3.6||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||3.60|1.58|<0.001
73885240|NCT00303069|147303901|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.4|||<|0.001|TWO_SIDED|95.0|1.6|32.1||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||32.1|1.6|<0.001
73885241|NCT00303069|147303901|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.5|||<|0.001|TWO_SIDED|95.0|-8.2|16.9||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||16.9|-8.2|<0.001
73885242|NCT02364700|147303912|EQUIVALENCE|Group means from baseline to discharge were compared to determine if 6-week and training on the Hand of Hope device elicited changes in outcome measures.|||||<|0.05|||||||Friedman Test|||||||<.05
73885243|NCT01280903|147303918|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
73885244|NCT01280903|147303919|SUPERIORITY|||||||0.13||||||p=0.130 for None to very low|Mixed Models Analysis|||||||0.130
73885245|NCT01280903|147303919|SUPERIORITY|||||||0.573||||||p=0.573 for Light|Mixed Models Analysis|||||||0.573
73885246|NCT01280903|147303919|SUPERIORITY|||||||0.197||||||p=0.197 for Moderate-to-vigorous|Mixed Models Analysis|||||||0.197
73885247|NCT01280903|147303920|SUPERIORITY|||||||0.461|||||||Mixed Models Analysis|||||||0.461
73885248|NCT01280903|147303921|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||0.180
74077175|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|||<|0.001|TWO_SIDED|95.0|2.06|4.15||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||4.15|2.06|<0.001
73885249|NCT01280903|147303922|SUPERIORITY|||||||0.258|||||||Mixed Models Analysis|||||||0.258
73885250|NCT01280903|147303923|SUPERIORITY|||||||0.416|||||||Mixed Models Analysis|||||||0.416
73885251|NCT01280903|147303924|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
73885252|NCT01280903|147303925|SUPERIORITY|||||||0.272||||||p=0.272 for None to very low|Mixed Models Analysis|||||||0.272
73885253|NCT01280903|147303925|SUPERIORITY|||||||0.823||||||p=0.823 for Light|Mixed Models Analysis|||||||0.823
73885254|NCT01280903|147303925|SUPERIORITY|||||||0.076||||||p=0.076 for Moderate-to-vigorous|Mixed Models Analysis|||||||0.076
73885255|NCT01280903|147303926|SUPERIORITY|||||||0.561|||||||Mixed Models Analysis|||||||0.561
73885256|NCT01280903|147303927|SUPERIORITY|||||||0.856|||||||Mixed Models Analysis|||||||0.856
73885257|NCT01280903|147303928|SUPERIORITY|||||||0.292|||||||Mixed Models Analysis|||||||0.292
73885258|NCT01280903|147303929|SUPERIORITY|||||||0.396|||||||Mixed Models Analysis|||||||0.396
73885259|NCT01280903|147303930|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.424
73885260|NCT01280903|147303931|SUPERIORITY|||||||0.586|||||||Mixed Models Analysis|||||||0.586
73885261|NCT01280903|147303932|SUPERIORITY|||||||0.596|||||||Mixed Models Analysis|||||||0.596
73885262|NCT01280903|147303933|SUPERIORITY|||||||0.639|||||||Mixed Models Analysis|||||||0.639
73885263|NCT01280903|147303934|SUPERIORITY|||||||0.466|||||||Mixed Models Analysis|||||||0.466
73885264|NCT01280903|147303935|SUPERIORITY|||||||0.322||||||p=0.322 for Short Form-36v2 Mental Component|Mixed Models Analysis|||||||0.322
73885265|NCT01280903|147303935|SUPERIORITY|||||||0.979||||||p=0.979 for Short Form-36v2 Physical Component|Mixed Models Analysis|||||||0.979
73885266|NCT01280903|147303936|SUPERIORITY|||||||0.71||||||p=0.710 for Exercise Barriers Self-Efficacy|Mixed Models Analysis|||||||0.710
73885267|NCT01280903|147303936|SUPERIORITY|||||||0.133||||||p=0.133 for Exercise Self-Efficacy|Mixed Models Analysis|||||||0.133
73885268|NCT01280903|147303937|SUPERIORITY|||||||0.005||||||p=0.005 for Arthritis Self Efficacy Pain|Mixed Models Analysis|||||||0.005
73885269|NCT01280903|147303937|SUPERIORITY|||||||0.948||||||p=0.948 for Arthritis Self Efficacy Function|Mixed Models Analysis|||||||0.948
73885270|NCT01280903|147303937|SUPERIORITY|||||||0.663||||||p=0.663 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis|||||||0.663
73885271|NCT01280903|147303938|SUPERIORITY|||||||0.001||||||p=0.001 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis|||||||0.001
73885272|NCT01280903|147303938|SUPERIORITY|||||||0.031||||||p=0.031 for Perceived Therapeutic Efficacy of Exercise and Hypertension|Mixed Models Analysis|||||||0.031
73885273|NCT01280903|147303939|SUPERIORITY|||||||0.816|||||||Mixed Models Analysis|||||||0.816
73885274|NCT01280903|147303940|SUPERIORITY|||||||0.895|||||||Mixed Models Analysis|||||||0.895
73885275|NCT01280903|147303941|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|||||||0.260
73885276|NCT01280903|147303942|SUPERIORITY|||||||0.993|||||||Mixed Models Analysis|||||||0.993
73885277|NCT01280903|147303943|SUPERIORITY|||||||0.947|||||||Mixed Models Analysis|||||||0.947
73885278|NCT01280903|147303944|SUPERIORITY|||||||0.406||||||p=0.406 for Short Form-36v2 Mental Component|Mixed Models Analysis|||||||0.406
73885279|NCT01280903|147303944|SUPERIORITY|||||||0.826||||||p=0.826 for Short Form-36v2 Physical Component|Mixed Models Analysis|||||||0.826
73885280|NCT01280903|147303945|SUPERIORITY|||||||0.95||||||p=0.950 for Exercise Barriers Self-Efficacy|Mixed Models Analysis|||||||0.950
73885281|NCT01280903|147303945|SUPERIORITY|||||||0.365||||||p=0.365 for Exercise Self-Efficacy|Mixed Models Analysis|||||||0.365
73885282|NCT01280903|147303946|SUPERIORITY|||||||0.219||||||p=0.219 for Arthritis Self Efficacy Pain|Mixed Models Analysis|||||||0.219
74077176|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.53|4.61||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||4.61|2.53|<0.001
74077177|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.61|3.67||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||3.67|1.61|<0.001
73885283|NCT01280903|147303946|SUPERIORITY|||||||0.34||||||p=0.340 for Arthritis Self Efficacy Function|Mixed Models Analysis|||||||0.340
73885284|NCT01280903|147303946|SUPERIORITY|||||||0.806||||||p=0.806 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis|||||||0.806
73885285|NCT01280903|147303947|SUPERIORITY|||||||0.008||||||p=0.008 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis|||||||0.008
73885286|NCT01280903|147303947|SUPERIORITY|||||||0.12||||||p=0.120 for Perceived Therapeutic Efficacy of Exercise and Hypertension|t-test, 1 sided|||||||0.120
73885287|NCT04026113|147303995|SUPERIORITY||Difference|1.17|STANDARD_ERROR_OF_MEAN|0.264|<|0.0001|TWO_SIDED|95.0|0.651|1.689||ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA|||||1.689|0.651|< 0.0001
74077178|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.15|||<|0.001|TWO_SIDED|95.0|2.09|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||4.21|2.09|<0.001
74077179|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||<|0.001|TWO_SIDED|95.0|2.36|4.46||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||4.46|2.36|<0.001
74077180|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED|95.0|1.36|3.44||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||3.44|1.36|<0.001
74077181|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.03|||<|0.001|TWO_SIDED|95.0|1.94|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||4.12|1.94|<0.001
74077182|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.99|||<|0.001|TWO_SIDED|95.0|1.91|4.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||4.07|1.91|<0.001
74077183|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|||<|0.001|TWO_SIDED|95.0|1.28|3.42||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||3.42|1.28|<0.001
74077184|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.001|TWO_SIDED|95.0|1.57|3.83||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.83|1.57|<0.001
74077185|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74|||<|0.001|TWO_SIDED|95.0|1.62|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.85|1.62|<0.001
74077186|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.14|3.37||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.37|1.14|<0.001
74077187|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.51|3.76||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.76|1.51|<0.001
74077188|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45|||<|0.001|TWO_SIDED|95.0|1.33|3.56||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.56|1.33|<0.001
74077189|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.36|||<|0.001|TWO_SIDED|95.0|1.25|3.47||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.47|1.25|<0.001
74077190|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02|||<|0.001|TWO_SIDED|95.0|0.86|3.19||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.19|0.86|<0.001
74077191|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.001|TWO_SIDED|95.0|0.75|3.05||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.05|0.75|0.001
74077192|NCT00913627|147708644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.05|3.34||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.34|1.05|<0.001
74077193|NCT00913627|147708645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.42|||<|0.001|TWO_SIDED|95.0|1.94|2.89||p-value adjusted for baseline PSR and gender|ANOVA|||||2.89|1.94|<0.001
74077194|NCT00913627|147708645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39|||<|0.001|TWO_SIDED|95.0|1.92|2.86||p-value adjusted for baseline PSR and gender|ANOVA|||||2.86|1.92|<0.001
74077195|NCT00913627|147708645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|||<|0.001|TWO_SIDED|95.0|1.58|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||||2.52|1.58|<0.001
74077196|NCT01110005|147708646|SUPERIORITY||Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.7|2.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR|||2.3|0.7|0.34
73888551|NCT01929317|147309698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-2.8|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, On status.|||0.3|-2.8|
74077197|NCT01110005|147708647|SUPERIORITY||Risk Ratio (RR)|1.1||||0.4|TWO_SIDED|95.0|0.9|1.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR|||1.3|0.9|0.40
74077198|NCT01110005|147708648|SUPERIORITY|||||||0.69|||||||Cochran-Mantel-Haenszel|This method was used to control for site of recruitment||||||0.69
74077199|NCT03123471|147708649|SUPERIORITY||Difference in Response|29.6|||<|0.0001|TWO_SIDED|95.0|19.5|39.7|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||39.7|19.5|< 0.0001
74077200|NCT03123471|147708650|SUPERIORITY||Difference in Response|23.0|||<|0.0001|TWO_SIDED|95.0|11.5|34.6|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||34.6|11.5|< 0.0001
74077201|NCT03123471|147708651|SUPERIORITY||Difference in Response|26.2|||<|0.0001|TWO_SIDED|95.0|13.9|38.5|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||38.5|13.9|< 0.0001
73885288|NCT04026113|147303995|SUPERIORITY|||||||0.4323||||||Treatment-by-Age Group Interaction P-value: Interaction P-value base on ANCOVA model with treatment, age group, treatment-by-age group interaction as factors and baseline value as a covariate.|ANCOVA|||||||0.4323
73885289|NCT04026113|147303997|SUPERIORITY||Difference|0.423|STANDARD_ERROR_OF_MEAN|0.109||0.0001|TWO_SIDED|95.0|0.208|0.638||ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA|||||0.638|0.208|0.0001
73885290|NCT04026113|147303997|SUPERIORITY|||||||0.4381||||||Treatment-by-Age Group Interaction P-value: Interaction P-value base on ANCOVA model with treatment, age group, treatment-by-age group interaction as factors and baseline value as a covariate.|ANCOVA|||||||0.4381
73885291|NCT04613362|147304003|SUPERIORITY||Odds Ratio (OR)|0.82||||0.61|TWO_SIDED|95.0|0.34|1.97||adjusted for gender which is included as a covariate|Mixed Models Analysis|||||1.97|0.34|0.61
74077202|NCT03123471|147708652|SUPERIORITY||Difference in Response|17.0|||<|0.0001|TWO_SIDED|95.0|9.8|24.2|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||24.2|9.8|<0.0001
74077203|NCT03123471|147708652|SUPERIORITY||Difference in Response|22.1|||<|0.0001|TWO_SIDED|95.0|12.9|31.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4. The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.4|12.9|<0.0001
74077204|NCT03123471|147708652|SUPERIORITY||Difference in Response|20.1||||0.0003|TWO_SIDED|95.0|9.1|31.0|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.0|9.1|0.0003
74077205|NCT03123471|147708652|SUPERIORITY||Difference in Response|20.6||||0.0007|TWO_SIDED|95.0|8.7|32.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.||32.4|8.7|0.0007
74077206|NCT03123471|147708653|SUPERIORITY||Difference in Response|14.6||||0.0025|TWO_SIDED|95.0|5.1|24.1|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||24.1|5.1|0.0025
73885292|NCT04613362|147304005|SUPERIORITY||Mean Difference (Net)|-8.8028|STANDARD_ERROR_OF_MEAN|6.3895||0.1724|TWO_SIDED|95.0|-21.5314|3.9257|||Mixed Models Analysis|||3 month||3.9257|-21.5314|0.1724
73885293|NCT04613362|147304005|SUPERIORITY||Mean Difference (Net)|-4.6533|STANDARD_ERROR_OF_MEAN|5.9929||0.4399|TWO_SIDED|95.0|-16.5917|7.2851|||Mixed Models Analysis|||6 months||7.2851|-16.5917|0.4399
73885294|NCT04613362|147304006|SUPERIORITY||Mean Difference (Net)|18.7886|STANDARD_ERROR_OF_MEAN|18.0826||0.3021|TWO_SIDED|95.0|-17.2261|54.8032|||Mixed Models Analysis|||3 months||54.8032|-17.2261|0.3021
73885295|NCT04613362|147304006|SUPERIORITY||Mean Difference (Net)|-5.1996|STANDARD_ERROR_OF_MEAN|17.1338||0.7624|TWO_SIDED|95.0|-39.3245|28.9254|||Mixed Models Analysis|||6 months||28.9254|-39.3245|0.7624
73885296|NCT04613362|147304007|SUPERIORITY||Mean Difference (Net)|5.9613|STANDARD_ERROR_OF_MEAN|4.3867||0.1783|TWO_SIDED|95.0|-2.7794|14.7019|||Mixed Models Analysis|||3 months||14.7019|-2.7794|0.1783
73885297|NCT04613362|147304007|SUPERIORITY||Mean Difference (Net)|-0.2145|STANDARD_ERROR_OF_MEAN|4.1565||0.959|TWO_SIDED|95.0|-8.4965|8.0675|||Mixed Models Analysis|||6 months||8.0675|-8.4965|0.959
73885298|NCT04613362|147304008|SUPERIORITY||Mean Difference (Net)|-12.6627|STANDARD_ERROR_OF_MEAN|7.3097||0.0873|TWO_SIDED|95.0|-27.2243|1.8989|||Mixed Models Analysis|||3 months||1.8989|-27.2243|0.0873
73885299|NCT04613362|147304008|SUPERIORITY||Mean Difference (Net)|-7.3578|STANDARD_ERROR_OF_MEAN|6.8559||0.2866|TWO_SIDED|95.0|-21.0154|6.2999|||Mixed Models Analysis|||6 months||6.2999|-21.0154|0.2866
73885300|NCT04613362|147304010|SUPERIORITY||Mean Difference (Net)|-1.5655|STANDARD_ERROR_OF_MEAN|1.4313||0.2776|TWO_SIDED|95.0|-4.4168|1.2859|||Mixed Models Analysis|||3 months||1.2859|-4.4168|0.2776
73885301|NCT04613362|147304010|SUPERIORITY||Mean Difference (Net)|0.7202|STANDARD_ERROR_OF_MEAN|1.6492||0.6636|TWO_SIDED|95.0|-2.5651|4.0055|||Mixed Models Analysis|||6 months||4.0055|-2.5651|0.6636
73885302|NCT04613362|147304011|SUPERIORITY||Mean Difference (Net)|2.3254|STANDARD_ERROR_OF_MEAN|1.6911||0.1733|TWO_SIDED|95.0|-1.0443|5.695|||Mixed Models Analysis|||3 months||5.695|-1.0443|0.1733
73885303|NCT04613362|147304011|SUPERIORITY||Mean Difference (Net)|-0.5408|STANDARD_ERROR_OF_MEAN|1.622||0.7398|TWO_SIDED|95.0|-3.7726|2.6911|||Mixed Models Analysis|||6 months||2.6911|-3.7726|0.7398
73885304|NCT04613362|147304012|SUPERIORITY||Mean Difference (Net)|-0.1491|STANDARD_ERROR_OF_MEAN|1.5551||0.9239|TWO_SIDED|95.0|-3.2476|2.9494|||Mixed Models Analysis|||Physical Component Scale - 3 months||2.9494|-3.2476|0.9239
73885305|NCT04613362|147304012|SUPERIORITY||Mean Difference (Net)|-0.2879|STANDARD_ERROR_OF_MEAN|1.4735||0.8456|TWO_SIDED|95.0|-3.2238|2.6481|||Mixed Models Analysis|||Physical Component Scale - 6 months||2.6481|-3.2238|0.8456
73885306|NCT04613362|147304012|SUPERIORITY||Mean Difference (Net)|-0.1757|STANDARD_ERROR_OF_MEAN|2.3798||0.9413|TWO_SIDED|95.0|-4.9175|4.5661|||Mixed Models Analysis|||Mental Component Scale - 3 months||4.5661|-4.9175|0.9413
73885307|NCT04613362|147304012|SUPERIORITY||Mean Difference (Net)|-2.9597|STANDARD_ERROR_OF_MEAN|2.2549||0.1934|TWO_SIDED|95.0|-7.4526|1.5333|||Mixed Models Analysis|||Mental Component Scale - 6 months||1.5333|-7.4526|0.1934
73885308|NCT04613362|147304013|SUPERIORITY||Mean Difference (Net)|3.0999|STANDARD_ERROR_OF_MEAN|2.1004||0.1442|TWO_SIDED|95.0|-1.0852|7.2849|||Mixed Models Analysis|||3 months||7.2849|-1.0852|0.1442
73885309|NCT04613362|147304013|SUPERIORITY||Mean Difference (Net)|2.0675|STANDARD_ERROR_OF_MEAN|2.036||0.3132|TWO_SIDED|95.0|-1.9892|6.1243|||Mixed Models Analysis|||6 months||6.1243|-1.9892|0.3132
73885310|NCT02218372|147304016|OTHER||adjusted treatment difference|7.5|||||TWO_SIDED|95.0|-7.4|23.9||||||Adjusted difference of CCR at EOT + 2 Days. Adjusted treatment difference of proportions was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. Newcombe 95% confidence intervals (CIs) presented for adjusted treatment difference.||23.9|-7.4|
73885311|NCT02218372|147304017|OTHER||adjusted treatment difference|16.3|||||TWO_SIDED|95.0|1.8|34.2||||||Adjusted difference of SCR at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.2|1.8|
73885312|NCT02218372|147304018|OTHER||adjusted treatment difference|21.3|||||TWO_SIDED|95.0|4.5|37.7||||||Adjusted difference of GC at EOT +9 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||37.7|4.5|
73885313|NCT02218372|147304019|OTHER||adjusted treatment difference|-16.3|||||TWO_SIDED|95.0|-34.2|-1.8||||||Adjusted difference of CDAD recurrence at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||-1.8|-34.2|
74077207|NCT03123471|147708653|SUPERIORITY||Difference in Response|21.3|||<|0.0001|TWO_SIDED|95.0|10.6|31.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.9|10.6|<0.0001
74077208|NCT03123471|147708653|SUPERIORITY||Difference in Response|22.0||||0.0003|TWO_SIDED|95.0|10.2|33.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||33.9|10.2|0.0003
74077209|NCT03123471|147708653|SUPERIORITY||Difference in Response|27.0|||<|0.0001|TWO_SIDED|95.0|15.1|38.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.||38.9|15.1|<0.0001
74077210|NCT03123471|147708654|SUPERIORITY||Difference in LS Mean|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.17|-1.73|||ANCOVA|Treatment and stratification factor (Baseline ScPGA moderate or severe) as independent variables and baseline value as a covariate variable.||||-1.73|-4.17|<0.0001
74077211|NCT01641380|147708658|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.75|||<|0.05|TWO_SIDED|95.0|-1.4|0.06|||Regression, Linear|||We also evaluated the difference between the number of days after the scheduled appointment patients returned.||.06|-1.4|<.05
74077212|NCT01641380|147708658|SUPERIORITY_OR_OTHER_LEGACY||Difference of proportions|0.417||||0.5187|TWO_SIDED|95.0|-13.3307|24.8818|||Chi-squared||Intervention 34/50; Control : 28/50|On time for 1st follow-up visit||24.8818|-13.3307|0.5187
74077213|NCT01641380|147708661|SUPERIORITY_OR_OTHER_LEGACY||[Proportion of Eligible Patients Enrolle|0.948|||||TWO_SIDED|||||||||||||
74077214|NCT03290781|147708687|SUPERIORITY||Difference in Proportion|0.451|||<|0.001|TWO_SIDED|95.0|0.296|0.572||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.572|0.296|<0.001
74077215|NCT03290781|147708687|SUPERIORITY||Difference in Proportion|0.278|||<|0.001|TWO_SIDED|95.0|0.142|0.401||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.401|0.142|<0.001
74077216|NCT03290781|147708688|SUPERIORITY||Difference in Proportion|0.463|||<|0.001|TWO_SIDED|95.0|0.31|0.585||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.585|0.310|<0.001
73885314|NCT02218372|147304020|OTHER||adjusted treatment difference|17.2|||||TWO_SIDED|95.0|1.9|35.6||||||Adjusted difference of SCR at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.6|1.9|
73885315|NCT02218372|147304021|OTHER||adjusted treatment difference|19.4|||||TWO_SIDED|95.0|2.3|35.9||||||Adjusted difference of GC at EOT +16 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.9|2.3|
73885316|NCT02218372|147304022|OTHER||adjusted treatment difference|-17.2|||||TWO_SIDED|95.0|-35.6|-1.9||||||Adjusted difference of CDAD Recurrence at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||-1.9|-35.6|
73885317|NCT02218372|147304023|OTHER||adjusted treatment difference|15.8|||||TWO_SIDED|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.5|-0.5|
73885318|NCT02218372|147304024|OTHER||adjusted treatment difference|18.8|||||TWO_SIDED|95.0|1.5|35.3||||||Adjusted difference of GC at EOT +23 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.3|1.5|
73885319|NCT02218372|147304025|OTHER||adjusted treatment difference|-15.8|||||TWO_SIDED|95.0|-34.5|0.5||||||Adjusted difference of CDAD Recurrence at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||0.5|-34.5|
73885320|NCT02218372|147304026|OTHER||adjusted treatment difference|15.8|||||TWO_SIDED|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOS (EOT +30 days). Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.5|-0.5|
73885321|NCT02218372|147304027|OTHER||adjusted treatment difference|18.8|||||TWO_SIDED|95.0|1.5|35.3||||||Adjusted difference of GC at EOS (EOT +30 days). Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.3|1.5|
73885322|NCT02218372|147304028|OTHER|Newcombe 95% CIs presented for adjusted treatment difference.|adjusted treatment difference|-15.8|||||TWO_SIDED|95.0|-34.5|0.5||||||Adjusted difference of CDAD recurrence at EOS/EOT +30 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||0.5|-34.5|
73885323|NCT02218372|147304029|OTHER|||||||0.579|||||||Log Rank|||Time to resolution of diarrhea.||||0.579
74077217|NCT03290781|147708688|SUPERIORITY||Difference in Proportion|0.339|||<|0.001|TWO_SIDED|95.0|0.197|0.463||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.463|0.197|<0.001
73885324|NCT02218372|147304030|OTHER|||||||0.023|||||||Log Rank|||Time to recurrence of CDAD.||||0.023
73885325|NCT02753283|147304039|SUPERIORITY||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.48||0.007|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.007
73885326|NCT02753283|147304039|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|1.09||0.018|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.018
73885327|NCT02753283|147304040|SUPERIORITY||Mean Difference (Final Values)|3.99|STANDARD_ERROR_OF_MEAN|1.45||0.014|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.014
73885328|NCT02753283|147304040|SUPERIORITY||Mean Difference (Final Values)|5.16|STANDARD_ERROR_OF_MEAN|1.45||0.002|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.002
73885329|NCT02753283|147304041|SUPERIORITY||Mean Difference (Final Values)|2.54|STANDARD_ERROR_OF_MEAN|1.26||0.06|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.060
74077218|NCT03290781|147708689|SUPERIORITY||Difference in Proportion|0.497|||<|0.001|TWO_SIDED|95.0|0.337|0.62||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.620|0.337|<0.001
73885330|NCT02753283|147304041|SUPERIORITY||Mean Difference (Final Values)|2.45|STANDARD_ERROR_OF_MEAN|1.22||0.055|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.055
74077219|NCT03290781|147708689|SUPERIORITY||Difference in Proportion|0.294|||<|0.001|TWO_SIDED|95.0|0.148|0.425||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.425|0.148|<0.001
73885331|NCT02753283|147304042|SUPERIORITY||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|1.37||0.112|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.112
73885332|NCT02753283|147304042|SUPERIORITY||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|1.34||0.07|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.070
74077220|NCT03290781|147708690|SUPERIORITY||Difference in Proportion|0.277|||<|0.001|TWO_SIDED|95.0|0.129|0.398||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.398|0.129|<0.001
74077221|NCT03290781|147708690|SUPERIORITY||Difference in Proportion|0.191|||<|0.001|TWO_SIDED|95.0|0.067|0.305||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.305|0.067|<0.001
73885333|NCT02753283|147304043|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.39||0.904|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.904
73885334|NCT02753283|147304043|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|2.29||0.616|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.616
74077222|NCT03290781|147708691|SUPERIORITY||Difference in Proportion|0.488|||<|0.001|TWO_SIDED|95.0|0.329|0.613||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.613|0.329|<0.001
74077223|NCT03290781|147708691|SUPERIORITY||Difference in Proportion|0.343|||<|0.001|TWO_SIDED|95.0|0.194|0.471||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.471|0.194|<0.001
74077224|NCT03290781|147708692|SUPERIORITY||Difference in Proportion|0.431|||<|0.001|TWO_SIDED|95.0|0.28|0.554||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.554|0.280|<0.001
74077225|NCT03290781|147708692|SUPERIORITY||Difference in Proportion|0.227|||<|0.001|TWO_SIDED|95.0|0.094|0.349||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.349|0.094|<0.001
74077226|NCT03290781|147708693|SUPERIORITY||Difference in Proportion|0.176|||<|0.001|TWO_SIDED|95.0|0.049|0.287||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.287|0.049|<0.001
74077227|NCT03290781|147708693|SUPERIORITY||Difference in Proportion|0.111|||<|0.005|TWO_SIDED|95.0|0.006|0.208||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.208|0.006|<0.005
74077228|NCT03290781|147708694|SUPERIORITY||||||<|0.001||||||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||||<0.001
74077229|NCT03290781|147708694|SUPERIORITY||||||=|0.005||||||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647- 303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||||=0.005
74077230|NCT03238781|147708700|SUPERIORITY||difference in least square mean|0.26||||0.66|TWO_SIDED|95.0|-0.88|1.4||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.40|-0.88|0.66
74077231|NCT03238781|147708700|SUPERIORITY||difference in least square mean|0.27||||0.65|TWO_SIDED|95.0|-0.89|1.43||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.43|-0.89|0.65
74077232|NCT03238781|147708701|SUPERIORITY||Odds Ratio (OR)|0.82||||0.57|TWO_SIDED|95.0|0.41|1.62||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).||1.62|0.41|0.57
74077233|NCT03238781|147708701|SUPERIORITY||Odds Ratio (OR)|0.76||||0.45|TWO_SIDED|95.0|0.37|1.54||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).||1.54|0.37|0.45
74077234|NCT03238781|147708702|SUPERIORITY||difference in least square mean|-0.03||||0.94|TWO_SIDED|95.0|-0.87|0.81||2-sided significance level of 0.05|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (CM versus EM), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||0.81|-0.87|0.94
74077235|NCT03238781|147708702|SUPERIORITY||difference in least square mean|-0.09||||0.84|TWO_SIDED|95.0|-0.94|0.77||2-sided significance level of 0.05|Mixed Models Analysis|||||0.77|-0.94|0.84
73885335|NCT02753283|147304044|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||<.001
73885336|NCT02753283|147304044|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.005|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.005
73885337|NCT02753283|147304045|SUPERIORITY||Mean Difference (Final Values)|-26.2|STANDARD_ERROR_OF_MEAN|6.0||0.001|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.001
73885338|NCT02753283|147304045|SUPERIORITY||Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|3.9||0.038|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.038
73885339|NCT04386291|147304046|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.071|TWO_SIDED||||||t-test, 1 sided|||||||0.071
73885340|NCT04386291|147304046|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.46|TWO_SIDED||||||t-test, 1 sided|||||||0.46
74077236|NCT03238781|147708703|SUPERIORITY||difference in least square mean|-0.28||||0.81|TWO_SIDED|95.0|-2.56|2.01||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.01|-2.56|0.81
74077237|NCT03238781|147708703|SUPERIORITY||difference in least square mean|0.31||||0.79|TWO_SIDED|95.0|-2.01|2.63||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.63|-2.01|0.79
74077238|NCT03238781|147708704|SUPERIORITY||difference in least square mean|-0.86||||0.46|TWO_SIDED|95.0|-3.15|1.44||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.44|-3.15|0.46
73885341|NCT04386291|147304047|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.01|TWO_SIDED||||||t-test, 1 sided|||||||0.01
73885342|NCT04386291|147304047|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.04|TWO_SIDED||||||t-test, 1 sided|||||||0.04
73885343|NCT04386291|147304048|SUPERIORITY||Mean Difference (Final Values)|-1.47||||0.08|TWO_SIDED||||||t-test, 1 sided|||||||0.08
73885344|NCT04386291|147304048|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.5|TWO_SIDED||||||t-test, 1 sided|||||||0.5
73885345|NCT04386291|147304049|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.25|TWO_SIDED||||||t-test, 1 sided|||||||0.25
73885346|NCT04386291|147304049|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.065|TWO_SIDED||||||t-test, 1 sided|||||||0.065
73885347|NCT04386291|147304050|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.88|TWO_SIDED||||||t-test, 1 sided|||||||0.88
73885348|NCT04386291|147304050|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.7|TWO_SIDED||||||t-test, 1 sided|||||||0.7
73885349|NCT04386291|147304051|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.038|TWO_SIDED||||||t-test, 1 sided|||||||0.038
73885350|NCT04386291|147304051|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.059|TWO_SIDED||||||t-test, 1 sided|||||||0.059
73885351|NCT04386291|147304052|SUPERIORITY||Median Difference (Final Values)|1.58||||0.9|TWO_SIDED||||||t-test, 1 sided|||Reappraisal subscale analysis||||0.9
73885352|NCT04386291|147304052|SUPERIORITY||Mean Difference (Net)|-0.73||||0.23|TWO_SIDED||||||t-test, 1 sided|||Subpression subscale analysis||||0.23
73885353|NCT04386291|147304052|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.7|TWO_SIDED||||||t-test, 1 sided|||Reappraisal subscale analysis||||0.7
73885354|NCT04386291|147304052|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5|TWO_SIDED||||||t-test, 1 sided|||Suppression subscale analysis||||0.5
73885355|NCT04386291|147304053|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.5|TWO_SIDED||||||ANOVA|||||||0.5
73885356|NCT04386291|147304054|SUPERIORITY||mean rank difference|79.0||||0.076|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann-Witney was used because assumption of normality of variance was violated||||||0.076
73885357|NCT04386291|147304054|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.8|TWO_SIDED||||||t-test, 1 sided|||||||0.8
73885358|NCT05172128|147304055|OTHER||||||>|0.05|||||||t-test, 2 sided||||Paired t-test comparing baseline value to endpoint value revealed a p-value of 0.80.|||>0.05
73885359|NCT05172128|147304056|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73885360|NCT05172128|147304057|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73885361|NCT05172128|147304058|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73885362|NCT05172128|147304061|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73885363|NCT01921205|147304069|SUPERIORITY||Percent reduction over Placebo|31.72|||=|0.0003|TWO_SIDED|95.0|16.342|44.277|||ANCOVA|Seizure frequency (log transformed) is analyzed using analysis of covariance with terms for treatment, pooled center and Baseline seizure frequency.|Percent reduction over placebo is estimated as 100 x (1-exp\[LSMLacosamide-LSMPlacebo\]). Where LSM is Least Square Mean.|||44.277|16.342|=0.0003
73885364|NCT01780506|147304110|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was \< 12% worse than the E/C/F/TDF group.|Difference in percentages|0.5||||0.78|TWO_SIDED|95.002|-3.0|4.0||P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL) and region (US vs ex-US).|Cochran-Mantel-Haenszel||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.|||4.0|-3.0|0.78
73885365|NCT03279081|147304143|SUPERIORITY||Difference in Combined Remission Rate|2.37|||=|0.571|TWO_SIDED|95.0|-5.82|10.55||P-value was based on stratified Cochran-Mantel-Haenszel (CMH) test adjusting for interactive web response system (IWRS) randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals (CI) are displayed.|||10.55|-5.82|=0.571
74077239|NCT03238781|147708704|SUPERIORITY||difference in least square mean|0.56||||0.64|TWO_SIDED|95.0|-1.77|2.89||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.89|-1.77|0.64
73885366|NCT03279081|147304144|SUPERIORITY||Difference in Clinical Remission Rate|2.72|||=|0.515|TWO_SIDED|95.0|-5.47|10.9||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||10.90|-5.47|=0.515
73885367|NCT03279081|147304145|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.374|TWO_SIDED|95.0|0.9|1.32||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate the hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.32|0.90|=0.374
73885368|NCT03279081|147304146|SUPERIORITY||Difference in Combined Remission Rate|1.27|||=|0.757|TWO_SIDED|95.0|-6.77|9.31||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||9.31|-6.77|=0.757
73885369|NCT03279081|147304147|SUPERIORITY||Difference in Clinical Remission Rate|1.6|||=|0.697|TWO_SIDED|95.0|-6.46|9.66||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||9.66|-6.46|=0.697
73885370|NCT03279081|147304148|SUPERIORITY||Difference in Clinical Response Rate|3.23|||=|0.428|TWO_SIDED|95.0|-4.76|11.21||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||11.21|-4.76|=0.428
73885371|NCT03279081|147304149|SUPERIORITY||Difference in Clinical Response Rate|2.84|||=|0.497|TWO_SIDED|95.0|-5.35|11.03||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||11.03|-5.35|=0.497
73885372|NCT03279081|147304150|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.363|TWO_SIDED|95.0|0.9|1.32||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.32|0.90|=0.363
74077240|NCT01581658|147708719|SUPERIORITY_OR_OTHER||Geometric mean ratio|128.82|||||TWO_SIDED|90.0|105.962|156.604|||ANOVA|The model includes fixed effect for the renal function group||||156.604|105.962|
73885373|NCT03279081|147304151|SUPERIORITY||Hazard Ratio (HR)|0.98|||=|0.833|TWO_SIDED|95.0|0.82|1.18||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.18|0.82|=0.833
73885374|NCT03279081|147304152|SUPERIORITY||Hazard Ratio (HR)|0.97|||=|0.717|TWO_SIDED|95.0|0.81|1.16||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.16|0.81|=0.717
73885375|NCT03279081|147304153|SUPERIORITY||Difference in Relapse Rate|3.03|||=|0.599|TWO_SIDED|95.0|-8.28|14.34||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||14.34|-8.28|=0.599
73885376|NCT03253796|147304168|SUPERIORITY||Difference in percentage|50.2|||<|0.001|TWO_SIDED|95.0|34.1|63.6|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||63.6|34.1|<0.001
73885377|NCT03253796|147304168|SUPERIORITY||Difference in percentage|34.4|||<|0.001|TWO_SIDED|95.0|17.0|49.7|||Meittinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||49.7|17.0|<0.001
73885378|NCT03253796|147304171|SUPERIORITY||Difference in percentage|9.5|||||TWO_SIDED|95.0|3.3|19.4|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||19.4|3.3|
73885379|NCT03253796|147304171|SUPERIORITY||Difference in percentage|3.2|||||TWO_SIDED|95.0|-2.8|10.9|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||10.9|-2.8|
73885380|NCT03253796|147304173|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-5.9|5.8|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||5.8|-5.9|
74077241|NCT01581658|147708719|SUPERIORITY_OR_OTHER||Geometric mean ratio|143.82|||||TWO_SIDED|90.0|118.306|174.848|||ANOVA|The model includes fixed effect for the renal function group||||174.848|118.306|
74077242|NCT01581658|147708719|SUPERIORITY_OR_OTHER||Geometric mean ratio|152.31|||||TWO_SIDED|90.0|125.287|185.166|||ANOVA|The model includes fixed effect for the renal function group||||185.166|125.287|
73885381|NCT03253796|147304173|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-5.9|5.8|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||5.8|-5.9|
73885382|NCT03253796|147304175|SUPERIORITY||Difference in percentage|14.7|||||TWO_SIDED|95.0|0.2|29.0|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||29.0|0.2|
73885383|NCT03253796|147304175|SUPERIORITY||Difference in percentage|14.7|||||TWO_SIDED|95.0|0.2|29.1|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||29.1|0.2|
74077243|NCT01581658|147708720|SUPERIORITY_OR_OTHER||Geometric mean ratio|93.5|||||TWO_SIDED|90.0|72.236|121.015|||ANOVA|The model includes fixed effect for the renal function group||||121.015|72.236|
74077244|NCT01581658|147708720|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.18|||||TWO_SIDED|90.0|71.216|119.305|||ANOVA|The model includes fixed effect for the renal function group||||119.305|71.216|
74077245|NCT01581658|147708720|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.01|||||TWO_SIDED|90.0|72.63|121.674|||ANOVA|The model includes fixed effect for the renal function group||||121.674|72.630|
74077246|NCT02538523|147708743|SUPERIORITY||||||<|0.005|||||||Fisher Exact|||A Fischer's Exact Test for two independent proportions was conducted to compare the statistical significance of the 44.8% difference in proportion of successes between procedure groups at two-months post-procedure (study endpoint) relative to baseline evaluation.||||<0.005
74077247|NCT02538523|147708744|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Differences is the statistical significance of change scores in ODI total score from study baseline to endpoint (two-months post-procedure) were evaluated by Analysis of Covariance (ANCOVA), with change from baseline to endpoint in ODI total score as the dependent variable, baseline ODI total score as the covariate and procedure group (Erchonia FX-635 or placebo laser) as a main effect.||||<0.05
74077248|NCT00795821|147708842|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
74077249|NCT00795821|147708844|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for multiple comparisons, the analysis of this secondary outcome measure was pre-specified as a gated secondary objective. As the primary hypothesis was statistically significant, this hypothesis was tested at the 0.05 significance level.|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
74077250|NCT00795821|147708846|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
74077251|NCT00795821|147708848|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
74077252|NCT00795821|147708850|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.007
74077253|NCT00795821|147708852|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.056
74077254|NCT00795821|147708854|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
74077255|NCT00795821|147708856|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
74077256|NCT00795821|147708858|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.003
74077257|NCT00795821|147708860|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.009
74077258|NCT00795821|147708862|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Severity of Overall Fatigue|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.008
74077259|NCT00795821|147708862|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for Fatigue Interference with Daily Activities|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.024
74077260|NCT00795821|147708864|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value for participants reporting use of primary doctor|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.261
74077261|NCT00795821|147708864|SUPERIORITY_OR_OTHER|||||||0.868||95.0||||P-value for participants reporting use of specialist|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.868
74077262|NCT00795821|147708864|SUPERIORITY_OR_OTHER|||||||0.495||95.0||||P-value for participants reporting other diagnostic tests|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.495
74077263|NCT00795821|147708864|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value for participants reporting prescribed medication|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.189
74077264|NCT00795821|147708866|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for suicidal ideation|Fisher Exact|||||||0.737
74077265|NCT00795821|147708868|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for change in supine systolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
74077266|NCT00795821|147708868|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in supine diastolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
74077267|NCT00795821|147708870|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
74077268|NCT01285713|147708873|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|95.0|||||Paired t-test|||||||0.0003
74077269|NCT03635320|147708894|NON_INFERIORITY|non-inferiority margin of -10%|95%CI|0.0|||||TWO_SIDED|95.0|-4.53|4.42|||Newcombe-Wilson scoring method|Using the Newcombe-Wilson scoring method, the difference of fracture union rate between the TFNA group and the PFNA-II group was 0.|If the lower limit of 95% CI of the difference in the rates of the study group and the control group is greater than the non-inferiority margin of -10%, then the investigational product is considered non-inferior to the control product.|||4.42|-4.53|
74077270|NCT00761813|147708918|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.63|1.09||||||||1.09|.63|
74077271|NCT00761813|147708919|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
74077272|NCT03049748|147708920|OTHER|This is a pilot randomized trial with a purpose of establishing preliminary efficacy data to inform future studies.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
74077273|NCT03049748|147708921|OTHER|Same rationale as the primary outcome.|||||>|0.05||||||All p-values across time periods, between groups, were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
73885384|NCT03253796|147304177|SUPERIORITY||Difference in percentage|24.9|||||TWO_SIDED|95.0|8.5|40.3|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||40.3|8.5|
73885385|NCT03253796|147304177|SUPERIORITY||Difference in percentage|5.9|||||TWO_SIDED|95.0|-9.9|21.3|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||21.3|-9.9|
73885386|NCT03253796|147304179|SUPERIORITY||Difference in percentage|24.4|||||TWO_SIDED|95.0|9.1|39.0|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||39.0|9.1|
73885387|NCT03253796|147304179|SUPERIORITY||Difference in percentage|22.8|||||TWO_SIDED|95.0|7.3|37.7|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||37.7|7.3|
73885388|NCT03253796|147304183|SUPERIORITY||Difference in percentage|32.9|||<|0.001|TWO_SIDED|95.0|19.2|44.5|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||44.5|19.2|<0.001
73885389|NCT03253796|147304184|SUPERIORITY||Difference in percentage|15.9||||0.037|TWO_SIDED|95.0|0.9|30.5|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||30.5|0.9|0.037
73885390|NCT01075243|147304192|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.71||||0.0009|TWO_SIDED|95.0|1.53|5.89|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 650 mg caplet.||5.89|1.53|0.0009
73885391|NCT01075243|147304192|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|11.33|||<|0.0001|TWO_SIDED|95.0|8.66|14.0|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.||14.00|8.66|<0.0001
73885392|NCT01075243|147304192|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.63|||<|0.0001||95.0|4.94|10.31|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 650 mg caplet and placebo caplet.||10.31|4.94|<0.0001
74077274|NCT03049748|147708922|OTHER||||||>|0.05||||||All p values between groups across time periods were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
74077275|NCT03049748|147708923|OTHER||||||>|0.05||||||All p-values between groups across time periods were \>.05|Wilcoxon (Mann-Whitney)|||||||>.05
74077276|NCT03049748|147708924|OTHER||||||>|0.05||||||All p-values between group differences across time periods were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
74077277|NCT03049748|147708925|OTHER|||||||0.05||||||Differences in group hospitalization rates p-values: T1 = .093; T2 = .008; T3 = .029|Wilcoxon (Mann-Whitney)|||||||0.05
73885393|NCT03094416|147304208|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.783797|STANDARD_ERROR_OF_MEAN|0.158271|<|0.0001|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||<0.0001
73885394|NCT03094416|147304209|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.037312|STANDARD_ERROR_OF_MEAN|0.026128||0.1607|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.1607
73885395|NCT03094416|147304210|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|3.397559|STANDARD_ERROR_OF_MEAN|4.174962||0.4204|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.4204
73885396|NCT03094416|147304211|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.055199|STANDARD_ERROR_OF_MEAN|0.019171||0.0062|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0062
73885397|NCT03094416|147304212|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|0.100127|STANDARD_ERROR_OF_MEAN|0.048171||0.0438|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0438
74077278|NCT00835484|147708926|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.15||||||90.0|91.77|102.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102.83|91.77|
74077279|NCT00835484|147708927|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.8||||||90.0|95.1|106.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.84|95.1|
74077280|NCT00835484|147708928|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.39||||||90.0|95.89|107.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.2|95.89|
73885398|NCT03094416|147304213|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.216479|STANDARD_ERROR_OF_MEAN|0.093366||0.0254|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0254
73885399|NCT03094416|147304214|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.011187|STANDARD_ERROR_OF_MEAN|0.036679||0.7619|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.7619
73885400|NCT03094416|147304215|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.121537|STANDARD_ERROR_OF_MEAN|0.064264||0.0655|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0655
73885401|NCT03094416|147304216|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.031636|STANDARD_ERROR_OF_MEAN|0.053033||0.5542|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.5542
73885402|NCT03094416|147304217|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.019322|STANDARD_ERROR_OF_MEAN|0.046827||0.682|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.6820
73885403|NCT03094416|147304218|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.049243|STANDARD_ERROR_OF_MEAN|0.024025||0.0468|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0468
74077281|NCT00905840|147708942|NON_INFERIORITY_OR_EQUIVALENCE|The analysis of the primary outcome variable, was based on a confirmatory non-inferiority test with a one-sided 97.5% confidence interval. The non-inferiority margin for a clinically relevant difference was set at 0.1 mm. For a sample size of st least 73, a paired t-test with a 0.0025 one-sided significant level was calculated to have 80% power to reject the hypothesis that the test is inferior to the standard.|Mean Difference (Final Values)|0.1||||0.025|TWO_SIDED|97.5|0.1|0.3|||Student's t-test|||"Null hypothesis: Change of functional bone level at the test implant 12 month after surgery is more than 0.1 lower (inferior) than change of functional crestal bone level at the control implant 12 month after surgery.~H-1: Change of functional bone level at the tst implant 12 month after surgery is up to 0.1 lower, equal, or higher (not inferior) than change of functional crestal bone level at the control implant 12 month after surgery."||0.3|0.1|0.025
74077282|NCT00905840|147708943|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED|95.0|||||McNemar|||This analysis is up to 12 month.||||0.1573
74077283|NCT00905840|147708944|SUPERIORITY_OR_OTHER|||||||0.3617|TWO_SIDED|||||12 month data Plaque index|Wilcoxon (Mann-Whitney)|||||||0.3617
74077284|NCT00905840|147708944|SUPERIORITY_OR_OTHER|||||||0.7068|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|24 month data Plaque index||||||0.7068
74077285|NCT00905840|147708944|SUPERIORITY_OR_OTHER|||||||0.4312|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|36 month data Plaque Index||||||0.4312
74077286|NCT00905840|147708944|SUPERIORITY_OR_OTHER|||||||0.9933|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|12 month data Sulcus Bleeding Index||||||0.9933
74077287|NCT00905840|147708944|SUPERIORITY_OR_OTHER|||||||0.3667|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|24 month data Sulcus Bleeding Index||||||0.3667
74077288|NCT00905840|147708944|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|36 month data Sulcus Bleeding Index||||||1.0000
74077289|NCT00834340|147709013|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.2|
74077290|NCT00834340|147709014|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|94.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|94.0|
74077291|NCT00834340|147709015|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|98.7|
74077292|NCT00840073|147709041|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.0||||||90.0|85.13|108.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.27|85.13|
74077293|NCT00840073|147709042|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.81||||||90.0|96.72|111.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.41|96.72|
74077294|NCT00840073|147709043|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|102.37||||||90.0|97.34|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.65|97.34|
74077295|NCT00840073|147709044|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.76||||||90.0|100.08|107.57|||||Informational Purposes Only|||107.57|100.08|
74077296|NCT00840073|147709045|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|103.34||||||90.0|100.84|105.92|||||Informational Purposes Only|||105.92|100.84|
74077297|NCT01172145|147709077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.385|STANDARD_ERROR_OF_MEAN|4.86||0.181|TWO_SIDED|95.0|-16.86|3.4|||t-test, 2 sided|||||3.40|-16.86|0.181
74077298|NCT02354339|147709088|SUPERIORITY|||||||0.24||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Irvingia gabonensis group||||0.240
74077299|NCT02354339|147709088|SUPERIORITY|||||||0.85||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group||||0.850
74077300|NCT02354339|147709089|SUPERIORITY|||||||0.012||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on Irvingia gabonensis group||||0.012
74077301|NCT02354339|147709089|SUPERIORITY|||||||0.391||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group||||0.391
74077302|NCT02354339|147709090|SUPERIORITY|||||||0.206||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on Irvingia gabonensis group||||0.206
74077303|NCT02354339|147709090|SUPERIORITY|||||||0.721||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group||||0.721
74077304|NCT02354339|147709091|SUPERIORITY|||||||0.371||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Irvingia gabonensis group||||0.371
74077305|NCT02354339|147709091|SUPERIORITY|||||||0.238||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group||||0.238
74077306|NCT02354339|147709092|SUPERIORITY|||||||0.452||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Irvingia gabonensis group||||0.452
74077307|NCT02354339|147709092|SUPERIORITY|||||||0.801||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on placebo group||||0.801
74077308|NCT02354339|147709093|SUPERIORITY|||||||0.005||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference on Irvingia gabonensis group||||0.005
74077309|NCT02354339|147709093|SUPERIORITY|||||||0.752||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference on placebo group||||0.752
74077310|NCT02354339|147709094|SUPERIORITY|||||||0.791|||||||Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Irvingia gabonensis group||||0.791
74077311|NCT02354339|147709094|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group||||0.910
74077312|NCT02354339|147709095|SUPERIORITY|||||||0.458||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Irvingia gabonensis group||||0.458
73885404|NCT03094416|147304219|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|-0.213171|STANDARD_ERROR_OF_MEAN|0.088103||0.0203|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0203
73885405|NCT03094416|147304220|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|-0.030904|STANDARD_ERROR_OF_MEAN|0.038699||0.4291|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.4291
73885406|NCT03094416|147304221|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.025502|STANDARD_ERROR_OF_MEAN|0.047802||0.5967|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.5967
73885407|NCT01668784|147304222|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0018|TWO_SIDED|98.52|0.57|0.93||The boundary for statistical significance required the p-value to be less than 0.0148 at the interim analyses.|Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio (HR) was Nivolumab over Everolimus.|||0.93|0.57|0.0018
73885408|NCT01668784|147304226|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.034|TWO_SIDED|95.0|0.72|0.99|||Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio is nivolumab over everolimus.|||0.99|0.72|0.0340
73885409|NCT01668784|147304232|SUPERIORITY||Stratified Cox Proportional hazard Model|0.74||||0.0001|TWO_SIDED|95.0|0.63|0.86|||Log Rank|||||0.86|0.63|0.0001
73885410|NCT02867436|147304233|SUPERIORITY||Mean Difference (Final Values)|205.0|||<|0.05|TWO_SIDED|95.0|-223.0|633.0|||Regression, Linear|||||633|-223|<0.05
73885411|NCT02867436|147304234|SUPERIORITY||Mean Difference (Final Values)|-7.8|||<|0.05|TWO_SIDED|95.0|-14.1|-1.6|||Regression, Linear|||||-1.6|-14.1|<0.05
73885412|NCT02867436|147304235|SUPERIORITY||Mean Difference (Final Values)|-0.15|||<|0.05|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||||0.01|-0.31|<0.05
73885413|NCT02867436|147304236|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73885414|NCT02867436|147304237|SUPERIORITY||||||<|0.05||||||After Benjamini-Hochberg correction for multiple comparisons|ANOVA|||||||<0.05
73885415|NCT05178173|147304238|SUPERIORITY|||||||0.59||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.59
73885416|NCT05178173|147304238|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.18
73885417|NCT05178173|147304238|SUPERIORITY|||||||0.78||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.78
73885418|NCT05178173|147304238|SUPERIORITY|||||||0.08||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.08
74077313|NCT02354339|147709095|SUPERIORITY|||||||0.953||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group||||0.953
73885419|NCT04607005|147304250|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.067|TWO_SIDED|95.0|-0.89|0.03||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||0.03|-0.89|0.067
73885420|NCT04607005|147304251|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.043|TWO_SIDED|95.0|-0.92|-0.02||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.02|-0.92|0.043
73885421|NCT04607005|147304252|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.003|TWO_SIDED|95.0|-2.37|-0.5||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.50|-2.37|0.003
73885422|NCT04607005|147304253|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.002|TWO_SIDED|95.0|-2.35|-0.51||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.51|-2.35|0.002
73885423|NCT04607005|147304254|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.003|TWO_SIDED|95.0|-2.52|-0.55||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.55|-2.52|0.003
73885424|NCT04607005|147304255|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.002|TWO_SIDED|95.0|-2.51|-0.57||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.57|-2.51|0.002
73885425|NCT04607005|147304256|SUPERIORITY||Mean Difference (Final Values)|-1.63||||0.012|TWO_SIDED|95.0|-2.9|-0.37||p-Value was based on a ANCOVA Model.|ANCOVA|||||-0.37|-2.90|0.012
73885426|NCT04607005|147304257|SUPERIORITY||Mean Difference (Final Values)|-1.67||||0.009|TWO_SIDED|95.0|-2.93|-0.42||p-Value was based on a ANCOVA Model.|ANCOVA|||||-0.42|-2.93|0.009
73885427|NCT04607005|147304258|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.005|TWO_SIDED|95.0|-1.99|-0.35||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.35|-1.99|0.005
73885428|NCT04607005|147304259|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.004|TWO_SIDED|95.0|-2.02|-0.4||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.40|-2.02|0.004
73885429|NCT04607005|147304260|SUPERIORITY||Mean Difference (Final Values)|-10.63||||0.01|TWO_SIDED|95.0|-18.68|-2.57||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-2.57|-18.68|0.010
73885430|NCT04607005|147304261|SUPERIORITY||Mean Difference (Final Values)|-11.39||||0.004|TWO_SIDED|95.0|-19.19|-3.6||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-3.60|-19.19|0.004
73885431|NCT04607005|147304262|SUPERIORITY||Mean Difference (Final Values)|-0.82||||0.009|TWO_SIDED|95.0|-1.43|-0.21||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.21|-1.43|0.009
73885432|NCT04607005|147304263|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.004|TWO_SIDED|95.0|-1.49|-0.28||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.28|-1.49|0.004
74077314|NCT02354339|147709096|SUPERIORITY|||||||0.47||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Irvingia gabonensis group||||0.470
74077315|NCT02354339|147709096|SUPERIORITY|||||||0.807||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group||||0.807
74077316|NCT02354339|147709097|SUPERIORITY|||||||0.604||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of body weight on Irvingia gabonensis group||||0.604
73885433|NCT04607005|147304264|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.026|TWO_SIDED|95.0|0.26|0.92||p-Value was based on Cox Proportional Hazards Model.|Cox proportional hazards model|||||0.92|0.26|0.026
74077317|NCT02354339|147709097|SUPERIORITY|||||||0.35||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of body weight on placebo group||||0.350
74077318|NCT02354339|147709098|SUPERIORITY|||||||0.727||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on Irvingia gabonensis group||||0.727
74077319|NCT02354339|147709098|SUPERIORITY|||||||0.229||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group||||0.229
74077320|NCT02354339|147709099|SUPERIORITY|||||||0.151||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Irvingia gabonensis group||||0.151
74077321|NCT02354339|147709099|SUPERIORITY|||||||0.955||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group||||0.955
74077322|NCT02354339|147709100|SUPERIORITY|||||||0.35||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of LDL-c on Irvingia gabonensis group||||0.350
74077323|NCT02354339|147709100|SUPERIORITY|||||||0.47||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of LDL-c on placebo group||||0.470
74077324|NCT02354339|147709101|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on Irvingia gabonensis group||||0.910
74077325|NCT02354339|147709101|SUPERIORITY|||||||0.436||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on placebo group||||0.436
74077326|NCT02354339|147709102|SUPERIORITY|||||||0.989||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on Irvingia gabonensis group||||0.989
74077327|NCT02354339|147709102|SUPERIORITY|||||||0.949||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group||||0.949
74077328|NCT02354339|147709103|SUPERIORITY|||||||0.095||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on Irvingia gabonensis group||||0.095
73885434|NCT04607005|147304265|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.018|TWO_SIDED|95.0|0.25|0.88||p-Value was based on Cox Proportional Hazards Model.|Cox proportional hazards model|||||0.88|0.25|0.018
73885435|NCT04272242|147304272|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.91|0.93|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for Cmax, comparing Day 28 to Day 0.||0.93|0.91|
74077329|NCT02354339|147709103|SUPERIORITY|||||||0.401||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group||||0.401
74077330|NCT02354339|147709104|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on Irvingia gabonensis group||||0.910
74077331|NCT02354339|147709104|SUPERIORITY|||||||0.791||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group||||0.791
74077332|NCT00796653|147709109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.091|0.167|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.167|0.091|<0.0001
74077333|NCT00796653|147709109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.116|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.191|0.116|<0.0001
74077334|NCT00796653|147709109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.112|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.188|0.112|<0.0001
74077335|NCT00796653|147709110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.019||0.0055||95.0|0.015|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.090|0.015|0.0055
74077336|NCT00796653|147709110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.106|0.032|0.0003
74077337|NCT00796653|147709110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.019||0.027||95.0|0.005|0.08|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.080|0.005|0.0270
74077338|NCT00796653|147709111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.314||0.1999||95.0|-0.213|1.018|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.018|-0.213|0.1999
74077339|NCT00796653|147709111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.314||0.1818||95.0|-0.196|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.035|-0.196|0.1818
74077340|NCT00796653|147709111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.602|STANDARD_ERROR_OF_MEAN|0.316||0.0572||95.0|-0.019|1.222|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.222|-0.019|0.0572
74077341|NCT00796653|147709112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.15|STANDARD_ERROR_OF_MEAN|1.349||0.0197||95.0|-5.796|-0.503|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.503|-5.796|0.0197
74077342|NCT00796653|147709112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.524|STANDARD_ERROR_OF_MEAN|1.354||0.0094||95.0|-6.18|-0.867|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.867|-6.180|0.0094
74077343|NCT00796653|147709112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.416|STANDARD_ERROR_OF_MEAN|1.365||0.2995||95.0|-4.093|1.261|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.261|-4.093|0.2995
74077344|NCT00796653|147709113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|STANDARD_ERROR_OF_MEAN|1.385||0.7995||95.0|-3.068|2.365|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||2.365|-3.068|0.7995
73888552|NCT01929317|147309698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-2.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, On status.|||0.7|-2.7|
74077345|NCT00796653|147709113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.391||0.4336||95.0|-3.818|1.639|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.639|-3.818|0.4336
74077346|NCT00796653|147709113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|1.395||0.9365||95.0|-2.625|2.848|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||2.848|-2.625|0.9365
74077347|NCT00796653|147709114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.625|STANDARD_ERROR_OF_MEAN|1.333||0.0491||95.0|-5.241|-0.01|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.010|-5.241|0.0491
74077348|NCT00796653|147709114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.489|STANDARD_ERROR_OF_MEAN|1.341||0.0636||95.0|-5.119|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.141|-5.119|0.0636
74077349|NCT00796653|147709114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.158|STANDARD_ERROR_OF_MEAN|1.35||0.0194||95.0|-5.806|-0.511|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||-0.511|-5.806|0.0194
74077350|NCT00796653|147709115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.972||0.0034|TWO_SIDED|95.0|-4.751|-0.94|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 5 mcg minus placebo||-0.940|-4.751|0.0034
74077351|NCT00796653|147709115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.434|STANDARD_ERROR_OF_MEAN|0.973||0.0004|TWO_SIDED|95.0|-5.343|-1.525|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 10 mcg minus placebo||-1.525|-5.343|0.0004
74077352|NCT00796653|147709115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.248|STANDARD_ERROR_OF_MEAN|0.976||0.2009|TWO_SIDED|95.0|-3.161|0.665|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Form 12 mcg minus placebo||0.665|-3.161|0.2009
74077353|NCT00796653|147709116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.123|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.196|0.123|<0.0001
74077354|NCT00796653|147709116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.193|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.157|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.157|<0.0001
74077355|NCT00796653|147709116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.126|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.199|0.126|<0.0001
74077356|NCT00796653|147709117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.136|<0.0001
74077357|NCT00796653|147709117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.155|0.228|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.228|0.155|<0.0001
74077358|NCT00796653|147709117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.148|0.221|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.221|0.148|<0.0001
74077359|NCT00796653|147709118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.108|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.182|0.108|<0.0001
74077360|NCT00796653|147709118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.138|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.138|<0.0001
74077361|NCT00796653|147709118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.133|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.208|0.133|<0.0001
74077362|NCT00796653|147709119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.08|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.156|0.080|<0.0001
74077363|NCT00796653|147709119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.180|0.103|<0.0001
74077364|NCT00796653|147709119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.091|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.168|0.091|<0.0001
74077365|NCT00796653|147709120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.018||0.0002||95.0|0.033|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|0.033|0.0002
74077366|NCT00796653|147709120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.083|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.155|0.083|<0.0001
74077367|NCT00796653|147709120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.018||0.0071||95.0|0.013|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.085|0.013|0.0071
74077368|NCT00796653|147709121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.048|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.120|0.048|<0.0001
74077369|NCT00796653|147709121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.068|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.141|0.068|<0.0001
73885436|NCT04272242|147304273|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.96|||||TWO_SIDED|90.0|0.96|0.96|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for AUC0-24, comparing Day 28 to Day 0.||0.96|0.96|
73885437|NCT04272242|147304274|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.97|1.0|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for Cmin, comparing Day 28 to Day 0.||1.00|0.97|
73885438|NCT02711891|147304288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Paired Sample T-test|||||||0.8
73885439|NCT02711891|147304288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Paired Sample T-test|||||||.003
73885440|NCT02711891|147304288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||t-test, 2 sided|||||||0.002
73885441|NCT02711891|147304290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||t-test, 1 sided|||||||0.01
73885442|NCT02711891|147304290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|0.05|||||Chi-squared|||||||.001
73885443|NCT02711891|147304292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876||||||Comparison of mean BPM during lance procedure for L1 vs L2 Loperamide.|t-test, 1 sided|||The population BPM lance one = population BPM mean lance two. Loperamide 1= Loperamide 2. Placebo 1=Placebo 2.||||.876
73885444|NCT02711891|147304292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.085||||||Comparison of the mean between HR one and HR two during the procedure for lance one will equal the mean HR lance two following loperamide gel application.|ANOVA|df 16.||Mean HR during the procedure for lance one will equal mean HR lance two following loperamide gel applciation||||.085
73885445|NCT04944992|147304301|SUPERIORITY||Difference in least squared means|30.4|||<|0.0001|TWO_SIDED|90.0|22.1|38.7|||Mixed Models Analysis|||||38.7|22.1|<0.0001
73885446|NCT04944992|147304302|OTHER|Difference (Efinopegdutide - Semaglutide) in %|difference in percentage|16.3||||||95.0|3.5|29.1||||||||29.1|3.5|
74077370|NCT00796653|147709121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.018||0.0001||95.0|0.034|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.106|0.034|0.0001
74077371|NCT00796653|147709122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.019||0.0017||95.0|0.022|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.095|0.022|0.0017
73885447|NCT04944992|147304303|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in percentage|5.6||||||95.0|0.4|13.5||||||||13.5|0.4|
73885448|NCT04944992|147304304|SUPERIORITY||Difference in least squared means|6.1|||<|0.001|TWO_SIDED|90.0|4.6|7.7|||Mixed Models Analysis|||||7.7|4.6|<0.001
74077372|NCT00796653|147709122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.057|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.130|0.057|<0.0001
73885449|NCT04944992|147304305|SUPERIORITY||Difference in Least Squared Means|-1.4||||0.085|TWO_SIDED|90.0|-2.7|-0.1|||Mixed Models Analysis|||||-0.1|-2.7|0.085
73885450|NCT04944992|147304306|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in Least Squared Means|-7.2|||||TWO_SIDED|90.0|-11.2|-3.1||||||||-3.1|-11.2|
73885451|NCT04944992|147304307|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-5.7||||||90.0|-10.9|-0.6||||||||-0.6|-10.9|
73885452|NCT04944992|147304308|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-11.7||||||90.0|-15.8|-7.7||||||||-7.7|-15.8|
73885453|NCT04944992|147304309|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-6.1||||||90.0|-12.0|-0.1||||||||-0.1|-12.0|
73885454|NCT04944992|147304310|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-7.6|||||TWO_SIDED|90.0|-14.3|-0.9||||||||-0.9|-14.3|
73885455|NCT04944992|147304311|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-5.4|||||TWO_SIDED|90.0|-10.4|-0.4||||||||-0.4|-10.4|
73885456|NCT01295814|147304312|NON_INFERIORITY_OR_EQUIVALENCE|"The study had acceptable sensitivity with a statistical power of 0.99 (99%) for the improvement in the adalimumab group from baseline to week 12.~The study had acceptable sensitivity with a statistical power of 0.92 (92%) for the improvement in the placebo group from baseline to week 12."|Mean Difference (Final Values)|7.9||||0.75|TWO_SIDED|95.0|4.0|11.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in OSPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||11.8|4.0|0.75
73885457|NCT01295814|147304313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.99|TWO_SIDED|95.0|1.7|6.3||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICSI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||6.3|1.7|0.99
73885458|NCT01295814|147304314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.76|TWO_SIDED|95.0|2.1|5.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||5.8|2.1|0.76
73885459|NCT01295814|147304315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.76|TWO_SIDED|95.0|2.6|10.0||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in PUF in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||10.0|2.6|0.76
73885460|NCT01295814|147304316|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided|||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||||0.67
73885461|NCT03414983|147304317|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.3022|TWO_SIDED|80.0|0.61|1.07||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.07|0.61|0.3022
74077373|NCT00796653|147709122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.019||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.101|0.028|0.0005
73885462|NCT03414983|147304317|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.3022|TWO_SIDED|95.0|0.53|1.23||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.23|0.53|0.3022
74077374|NCT00796653|147709123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.0085||95.0|0.013|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.087|0.013|0.0085
74077375|NCT00796653|147709123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.049|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.122|0.049|<0.0001
74077376|NCT00796653|147709123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.019||0.0067||95.0|0.014|0.088|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.088|0.014|0.0067
73885463|NCT03414983|147304318|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.19|||||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.19|0.54|
73885464|NCT03414983|147304333|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5041|TWO_SIDED|80.0|0.67|1.15||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.15|0.67|0.5041
73885465|NCT03414983|147304333|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5041|TWO_SIDED|95.0|0.58|1.32||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.32|0.58|0.5041
74077377|NCT00796653|147709124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0012||95.0|0.025|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.100|0.025|0.0012
74077378|NCT00796653|147709124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.035|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.110|0.035|0.0002
74077379|NCT00796653|147709124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.019||0.0117||95.0|0.011|0.086|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.086|0.011|0.0117
73885466|NCT02958917|147304341|SUPERIORITY||Mean Difference (Final Values)|-0.76|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
74077380|NCT00796653|147709125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0014||95.0|0.024|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.099|0.024|0.0014
74077381|NCT00796653|147709125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.047|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.122|0.047|<0.0001
74077382|NCT00796653|147709125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.019||0.0035||95.0|0.019|0.094|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.094|0.019|0.0035
74077383|NCT00796653|147709126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.019||0.0228||95.0|0.006|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.082|0.006|0.0228
74077384|NCT00796653|147709126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.019||0.0024||95.0|0.021|0.097|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.097|0.021|0.0024
74077385|NCT00796653|147709126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.019||0.0664||95.0|-0.002|0.074|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.074|-0.002|0.0664
74077386|NCT00796653|147709127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.122|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.199|0.122|<0.0001
74077387|NCT00796653|147709127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.14|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.216|0.140|<0.0001
74077388|NCT00796653|147709127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.115|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.191|0.115|<0.0001
74077389|NCT00796653|147709128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.13|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.207|0.130|<0.0001
74077390|NCT00796653|147709128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.143|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.220|0.143|<0.0001
74077391|NCT00796653|147709128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.137|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.214|0.137|<0.0001
74077392|NCT00796653|147709129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.180|0.103|<0.0001
74077393|NCT00796653|147709129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.129|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.207|0.129|<0.0001
73885467|NCT02958917|147304342|SUPERIORITY||Cox Proportional Hazard|0.264|||<|0.05|TWO_SIDED|95.0|||||Regression, Cox|||||||<0.05
74077394|NCT00796653|147709129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.125|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.203|0.125|<0.0001
74077395|NCT00796653|147709130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.084|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.163|0.084|<0.0001
73885468|NCT02958917|147304343|SUPERIORITY||Slope|2.03|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
74077396|NCT00796653|147709130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.112|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.191|0.112|<0.0001
74077397|NCT00796653|147709130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.104|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.183|0.104|<0.0001
74077398|NCT00796653|147709131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.071|0.152|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.152|0.071|<0.0001
74077399|NCT00796653|147709131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.086|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.166|0.086|<0.0001
74077400|NCT00796653|147709131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.078|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.158|0.078|<0.0001
74077401|NCT00796653|147709132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.162|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.162|<0.0001
74077402|NCT00796653|147709132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.182|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.182|<0.0001
74077403|NCT00796653|147709132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.266|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.198|0.334|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.334|0.198|<0.0001
74077404|NCT00796653|147709133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.182|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.320|0.182|<0.0001
74077405|NCT00796653|147709133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.18|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.180|<0.0001
74077406|NCT00796653|147709133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.350|0.212|<0.0001
73885469|NCT02958917|147304344|SUPERIORITY||Median Difference (Final Values)|-0.108|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
73885470|NCT02958917|147304345|SUPERIORITY||Risk Difference (RD)|0.364|||<|0.05|TWO_SIDED||||||Log Rank|||||||<0.05
73885471|NCT02958917|147304346|SUPERIORITY||Risk Difference (RD)|0.128|||<|0.05|TWO_SIDED|95.0|||||Log Rank|||||||<0.05
74077407|NCT00796653|147709134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.159|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.159|<0.0001
74077408|NCT00796653|147709134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.177|0.317|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.317|0.177|<0.0001
73885472|NCT02958917|147304347|SUPERIORITY||Mean Difference (Final Values)|-2.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
73885473|NCT02958917|147304348|SUPERIORITY||Mean Difference (Final Values)|-6.72|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
73885474|NCT02958917|147304349|SUPERIORITY||Mean Difference (Final Values)|-4.92|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
73885475|NCT02958917|147304350|SUPERIORITY||Mean Difference (Final Values)|-7.92|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
73885476|NCT02958917|147304351|SUPERIORITY||Mean Difference (Final Values)|-2.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
74077409|NCT00796653|147709134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.205|0.345|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.345|0.205|<0.0001
74077410|NCT00796653|147709135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.128|0.27|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.270|0.128|<0.0001
74077411|NCT00796653|147709135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.142|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.283|0.142|<0.0001
73885477|NCT00804908|147304383|SUPERIORITY_OR_OTHER||||||=|0.071|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; \>1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.||||=0.071
74077412|NCT00796653|147709135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.17|0.312|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.312|0.170|<0.0001
74077413|NCT00796653|147709136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.146|0.29|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.290|0.146|<0.0001
74077414|NCT00796653|147709136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.166|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.309|0.166|<0.0001
74077415|NCT00796653|147709136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.148|0.292|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.292|0.148|<0.0001
74077416|NCT00796653|147709137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.035||0.0133||95.0|0.018|0.157|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.157|0.018|0.0133
73888553|NCT01929317|147309698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.8|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, Off status.|||0.5|-1.8|
74077417|NCT00796653|147709137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.073|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.073|<0.0001
74077418|NCT00796653|147709137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.035||0.0212||95.0|0.012|0.151|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.151|0.012|0.0212
74077419|NCT00796653|147709138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.036||0.0004||95.0|0.057|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.057|0.0004
74077420|NCT00796653|147709138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.036||0.0012||95.0|0.045|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.185|0.045|0.0012
74077421|NCT00796653|147709138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.036||0.0056||95.0|0.029|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.169|0.029|0.0056
74077422|NCT00796653|147709139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.036||0.0045||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.173|0.032|0.0045
74077423|NCT00796653|147709139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.036||0.0046||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.173|0.032|0.0046
74077424|NCT00796653|147709139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.036||0.0023||95.0|0.039|0.181|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.181|0.039|0.0023
74077425|NCT00796653|147709140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.037||0.0077||95.0|0.026|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.169|0.026|0.0077
74077426|NCT00796653|147709140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.036||0.0009||95.0|0.05|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.050|0.0009
74077427|NCT00796653|147709140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.037||0.0339||95.0|0.006|0.149|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.149|0.006|0.0339
74077428|NCT00796653|147709141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.037||0.0718||95.0|-0.006|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.139|-0.006|0.0718
74077429|NCT00796653|147709141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.037||0.0863||95.0|-0.009|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.135|-0.009|0.0863
74077430|NCT00796653|147709141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.037||0.2982||95.0|-0.034|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.111|-0.034|0.2982
74077431|NCT00796653|147709142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.037||0.019||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.160|0.014|0.0190
74077432|NCT00796653|147709142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.037||0.0601||95.0|-0.003|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.003|0.0601
74077433|NCT00796653|147709142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.037||0.2573||95.0|-0.031|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.115|-0.031|0.2573
74077434|NCT00796653|147709143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.037||0.02||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.160|0.014|0.0200
74077435|NCT00796653|147709143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.047|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.194|0.047|0.0013
74077436|NCT00796653|147709143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.037||0.1598||95.0|-0.021|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.126|-0.021|0.1598
73888554|NCT01929317|147309698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.6|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, Off status.|||0.8|-2.6|
73885478|NCT00804908|147304383|SUPERIORITY_OR_OTHER||||||=|0.233|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; \>1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.||||=0.233
74077437|NCT00796653|147709144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.038||0.0307||95.0|0.008|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.155|0.008|0.0307
74077438|NCT00796653|147709144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.038||0.0073||95.0|0.027|0.175|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.175|0.027|0.0073
74077439|NCT00796653|147709144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.038||0.3147||95.0|-0.036|0.112|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.112|-0.036|0.3147
74077440|NCT00796653|147709145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.16|0.306|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.306|0.160|<0.0001
74077441|NCT00796653|147709145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.156|0.302|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.302|0.156|<0.0001
74077442|NCT00796653|147709145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.175|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.321|0.175|<0.0001
74077443|NCT00796653|147709146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.174|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.321|0.174|<0.0001
74077444|NCT00796653|147709146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.148|0.295|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.295|0.148|<0.0001
73888385|NCT02900378|147309611|OTHER||Differences of least square means|-6.14|STANDARD_ERROR_OF_MEAN|8.61||0.4769|TWO_SIDED|97.5|-25.7|13.41||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with MI)||13.41|-25.70|0.4769
74077445|NCT00796653|147709146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.18|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.328|0.180|<0.0001
74077446|NCT00796653|147709147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.141|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.289|0.141|<0.0001
74077447|NCT00796653|147709147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.151|0.3|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.300|0.151|<0.0001
74077448|NCT00796653|147709147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.191|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.340|0.191|<0.0001
74077449|NCT00796653|147709148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.106|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.258|0.106|<0.0001
74077450|NCT00796653|147709148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.105|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.256|0.105|<0.0001
74077451|NCT00796653|147709148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.132|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.283|0.132|<0.0001
74077452|NCT00796653|147709149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.111|0.265|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.265|0.111|<0.0001
74077453|NCT00796653|147709149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.138|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.291|0.138|<0.0001
74077454|NCT00796653|147709149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.115|0.269|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.269|0.115|<0.0001
74077455|NCT00796653|147709150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.707|STANDARD_ERROR_OF_MEAN|4.435||0.0021|TWO_SIDED|95.0|5.004|22.411|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||22.411|5.004|0.0021
74077456|NCT00796653|147709150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.871|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|12.158|29.584|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||29.584|12.158|<0.0001
74077457|NCT00796653|147709150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.249|STANDARD_ERROR_OF_MEAN|4.454||0.0014|TWO_SIDED|95.0|5.506|22.991|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||22.991|5.506|0.0014
74077458|NCT00796653|147709150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|STANDARD_ERROR_OF_MEAN|4.463||0.0001|TWO_SIDED|95.0|8.64|26.16|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||26.160|8.640|0.0001
74077459|NCT00796653|147709150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.875|STANDARD_ERROR_OF_MEAN|4.444|<|0.0001|TWO_SIDED|95.0|14.153|31.596|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||31.596|14.153|<0.0001
74077460|NCT00796653|147709150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.816|STANDARD_ERROR_OF_MEAN|4.475||0.0004|TWO_SIDED|95.0|7.032|24.599|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||24.599|7.032|0.0004
74077461|NCT00796653|147709151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153|STANDARD_ERROR_OF_MEAN|0.121||0.2057|TWO_SIDED|95.0|-0.391|-0.084|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.084|-0.391|0.2057
74077462|NCT00796653|147709151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.121||0.0284|TWO_SIDED|95.0|-0.504|-0.028|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.028|-0.504|0.0284
74077463|NCT00796653|147709151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.122||0.0685|TWO_SIDED|95.0|-0.461|0.017|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||0.017|-0.461|0.0685
74077464|NCT00796653|147709151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278|STANDARD_ERROR_OF_MEAN|0.152||0.0674|TWO_SIDED|95.0|-0.576|0.02|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||0.020|-0.576|0.0674
74077465|NCT00796653|147709151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.365|STANDARD_ERROR_OF_MEAN|0.0163||0.0163|TWO_SIDED|95.0|-0.662|-0.067|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.067|-0.662|0.0163
73885479|NCT03181932|147304391|SUPERIORITY|The primary efficacy endpoint was tested sequentially at Week 4 (end of Cycle 1), Week 12 (end of Cycle 2) and at Week 20 (end of Cycle 3). If a statistically significant difference was observed in favor of vancomycin inhalation powder compared to placebo after Cycle 1, then the mean change in the FEV1 percent predicted during Cycle 2 was to be tested. Similarly, if the effect after Cycle 2 was statistically significant, then the analysis of Baseline to end of Cycle 3 was to be tested.|Least square mean difference|1.4||||0.325|TWO_SIDED|95.0|-1.4|4.1|||Mixed Models Analysis|||Based on previous experience, a sample size of 45 participants per arm would provide 89% power to detect a statistically significant difference at alpha level of 0.05. To account for potential dropouts and/or smaller effect size in a 3-cycle trial, a sample size of 75 participants per arm was to be enrolled in the primary analysis population, which if all completed would provide 90% power to detect a difference of 3.4% at 20 weeks assuming the same standard deviation of 6.3%.||4.1|-1.4|0.325
73885480|NCT02220920|147304402|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-1.33|-0.87|||ANCOVA|||||-0.87|-1.33|<0.001
73885481|NCT02220920|147304403|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-32.6|STANDARD_ERROR_OF_MEAN|6.9|<|0.001|TWO_SIDED|95.0|-46.3|-18.9|||ANCOVA|||||-18.9|-46.3|<0.001
74077466|NCT00796653|147709151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.153||0.0364|TWO_SIDED|95.0|-0.62|-0.02|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.020|-0.620|0.0364
74077467|NCT00796653|147709151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.424|STANDARD_ERROR_OF_MEAN|0.254||0.0959|TWO_SIDED|95.0|-0.922|0.075|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||0.075|-0.922|0.0959
74077468|NCT00796653|147709151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.616|STANDARD_ERROR_OF_MEAN|0.254||0.0155|TWO_SIDED|95.0|-1.115|-0.117|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.117|-1.115|0.0155
73885482|NCT02220920|147304404|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-3.09|-1.65|||ANCOVA|||||-1.65|-3.09|<0.001
73885483|NCT02220920|147304405|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.19|STANDARD_ERROR_OF_MEAN|1.67||0.058|TWO_SIDED|95.0|-6.49|0.11|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in systolic blood pressure for week 16.|||0.11|-6.49|0.058
73885484|NCT02220920|147304405|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|1.03||0.232|TWO_SIDED|95.0|-3.27|0.8|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in diastolic blood pressure for week 16.|||0.80|-3.27|0.232
73885485|NCT04723056|147304412|OTHER|||||||0.282||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||0.282
73885486|NCT04723056|147304413|OTHER|||||||0.217||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||0.217
73885487|NCT04723056|147304414|OTHER|||||||0.462||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||0.462
73885488|NCT04723056|147304414|OTHER|||||||0.179||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||0.179
73885489|NCT04723056|147304415|OTHER|||||||0.573||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||.573
73885490|NCT04723056|147304415|OTHER|||||||0.606||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.606
73885491|NCT04723056|147304416|OTHER|||||||0.181||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.181
73885492|NCT04723056|147304417|OTHER|||||||0.407||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.407
73885493|NCT04723056|147304418|OTHER|||||||0.643||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.643
73885494|NCT04723056|147304419|OTHER|||||||0.625||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||.625
73885495|NCT04723056|147304419|OTHER|||||||0.707||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.707
73885496|NCT05106894|147304421|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-7.4|5.5||||||||5.5|-7.4|
73888555|NCT01929317|147309698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.8|1.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, Off status.|||1.0|-2.8|
74077469|NCT00796653|147709151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.541|STANDARD_ERROR_OF_MEAN|0.256||0.0347|TWO_SIDED|95.0|-1.042|-0.039|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.039|-1.042|0.0347
74077470|NCT00796653|147709152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0164||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0164
73885497|NCT05106894|147304422|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Median Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-8.3|3.6||||||||3.6|-8.3|
73885498|NCT05106894|147304423|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-5.6|2.1||||||||2.1|-5.6|
73885499|NCT04196777|147304461|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 3. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|0.089||||0.004|TWO_SIDED|95.0|0.016|0.445|||Regression, Logistic|||To model the primary outcome for site 3, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||0.445|0.016|0.004
73885500|NCT04196777|147304461|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 1. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|1.593||||0.259|TWO_SIDED|95.0|0.71|3.585|||Regression, Logistic|||To model the primary outcome for site 1, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||3.585|0.710|0.259
73885501|NCT04196777|147304461|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 2. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|0.748||||0.738|TWO_SIDED|95.0|0.135|4.147|||Regression, Logistic|||To model the primary outcome for site 2, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||4.147|0.135|0.738
73885502|NCT04196777|147304462|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 3 between the baseline and intervention periods.|Rank sum test statistic|1280.5||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 3 were compared using the Wilcoxon rank-sum test.||||0.001
74077471|NCT00796653|147709152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0196||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.0|-0.4|0.0196
74077472|NCT00796653|147709152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0041||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0041
73885503|NCT04196777|147304462|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 1 between the baseline and intervention periods.|Rank sum test statistic|28662.0||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 1 were compared using the Wilcoxon rank-sum test.Type of statistical test||||0.013
73885504|NCT04196777|147304462|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 2 between the baseline and intervention periods.|Rank sum test statistic|784.0||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 2 were compared using the Wilcoxon rank-sum test.||||0.14
73885505|NCT04196777|147304463|OTHER|We performed a logistic regression model that included patients across all 3 sites.|Odds Ratio (OR)|0.76||||0.04|TWO_SIDED|95.0|0.58|0.99|||Regression, Logistic|||To model this secondary outcome, we used a logistic regression model and a set of four explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, an interaction term between these two main effects (time and intervention), and a binary indicator for the primary outcome. This last variable was included to assess the risk of these secondary outcomes in patients who were not exposed to post-procedural antimicrobials compared to those who were exposed.||0.99|0.58|0.04
74077473|NCT00796653|147709153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0388||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0388
74077474|NCT00796653|147709153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0038||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0038
74077475|NCT00796653|147709153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0053||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0053
74077476|NCT00796653|147709154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0555||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.0|-0.4|0.0555
73885506|NCT04196777|147304464|OTHER|We performed a logistic regression model that included patients across all 3 sites.|Odds Ratio (OR)|0.68|||<|0.01|TWO_SIDED|95.0|0.53|0.87|||Regression, Logistic|||To model this secondary outcome across all sites, we used a logistic regression model and a set of four explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, an interaction term between these two main effects (time and intervention), and a binary indicator for the primary outcome.||0.87|0.53|<0.01
74077477|NCT00796653|147709154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0122||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.4|0.0122
74077478|NCT00796653|147709154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0144||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.4|0.0144
74077479|NCT00796653|147709155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5707||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.1|-0.3|0.5707
74077480|NCT00796653|147709155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0814||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||0.0|-0.4|0.0814
74077481|NCT00796653|147709155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7413||95.0|-0.2|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.2|-0.2|0.7413
74077482|NCT00796653|147709156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.437|STANDARD_ERROR_OF_MEAN|0.305||0.1524||95.0|-0.162|1.036|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.036|-0.162|0.1524
74077483|NCT00796653|147709156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.706|STANDARD_ERROR_OF_MEAN|0.306||0.0211||95.0|0.106|1.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.307|0.106|0.0211
73888386|NCT02900378|147309611|OTHER||Differences of least square means|-5.67|STANDARD_ERROR_OF_MEAN|6.01||0.3463|TWO_SIDED|95.0|-17.48|6.14||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with LOCF)||6.14|-17.48|0.3463
74077484|NCT00796653|147709156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.464|STANDARD_ERROR_OF_MEAN|0.307||0.1314||95.0|-0.139|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.066|-0.139|0.1314
74077485|NCT00796653|147709157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.662|STANDARD_ERROR_OF_MEAN|0.308||0.0319||95.0|0.057|1.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.267|0.057|0.0319
74077486|NCT00796653|147709157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.667|STANDARD_ERROR_OF_MEAN|0.31||0.0312||95.0|0.06|1.274|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.274|0.060|0.0312
74077487|NCT00796653|147709157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.311||0.1777||95.0|-0.191|1.029|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.029|-0.191|0.1777
74077488|NCT00796653|147709158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.425|STANDARD_ERROR_OF_MEAN|0.311||0.1714||95.0|-0.184|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.035|-0.184|0.1714
74077489|NCT00796653|147709158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.492|STANDARD_ERROR_OF_MEAN|0.312||0.1142||95.0|-0.119|1.103|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.103|-0.119|0.1142
74077490|NCT00796653|147709158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|0.314||0.0888||95.0|-0.081|1.15|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.150|-0.081|0.0888
74077491|NCT00796653|147709159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.318||0.1235||95.0|-0.134|1.113|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.113|-0.134|0.1235
74077492|NCT00796653|147709159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354|STANDARD_ERROR_OF_MEAN|0.318||0.2666||95.0|-0.271|0.978|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.978|-0.271|0.2666
73885507|NCT00981656|147304471|OTHER|No testing is done, conclusions are made based on the confidence interval.||||||||||||||||Null hypothesis = this treatment will result in 75% of participants free from radical cystectomy at 3 years. A lower confidence bound of 60% will be promising enough to pursue this regimen further. A sample size of 33 analyzable patients provides a one-sided 97.5% lower bound of 60% relative to the hypothesized 75%. In terms of type I error, this design provides a 2.5% chance of observing a 3-year percentage less than 60% if the true rate is 75%.|If the lower confidence interval (CI) limit was above 60% then the regimen would be considered promising enough to warrant further study for this treatment regimen. If the lower limit was below 25% then the treatment would not be considered worthy of further study. If the lower limit fell between 25% and 60%, the investigators would consider the possibility of further investigation.|||
74077493|NCT00796653|147709159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.319||0.3335||95.0|-0.317|0.934|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.934|-0.317|0.3335
73885508|NCT00129402|147304527|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
74077494|NCT00796653|147709160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.313|STANDARD_ERROR_OF_MEAN|0.32||0.3287||95.0|-0.315|0.941|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.941|-0.315|0.3287
74077495|NCT00796653|147709160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.481|STANDARD_ERROR_OF_MEAN|0.321||0.1341||95.0|-0.148|1.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.109|-0.148|0.1341
74077496|NCT00796653|147709160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.322||0.722||95.0|-0.516|0.745|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.745|-0.516|0.7220
74077497|NCT00796653|147709161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.397|STANDARD_ERROR_OF_MEAN|0.322||0.2176||95.0|-0.234|1.027|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.027|-0.234|0.2176
74077498|NCT00796653|147709161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.718|STANDARD_ERROR_OF_MEAN|0.323||0.0258||95.0|0.087|1.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.348|0.087|0.0258
74077499|NCT00796653|147709161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.323||0.6044||95.0|-0.466|0.8|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.800|-0.466|0.6044
74077500|NCT00796653|147709162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.802|STANDARD_ERROR_OF_MEAN|0.133||0.1946||95.0|0.58|1.111|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.111|0.580|0.1946
74077501|NCT00796653|147709162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872|STANDARD_ERROR_OF_MEAN|0.141||0.4071||95.0|0.634|1.198|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.198|0.634|0.4071
73885509|NCT00129402|147304528|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
73885510|NCT00129402|147304529|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
73885511|NCT00129402|147304530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0|||||non-parametric model|||||||.48
74077502|NCT00796653|147709162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.922|STANDARD_ERROR_OF_MEAN|0.15||0.6404||95.0|0.67|1.267|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.267|0.670|0.6404
74077503|NCT00796653|147709163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.685|STANDARD_ERROR_OF_MEAN|0.249||0.2942||95.0|0.336|1.399|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.399|0.336|0.2942
74077504|NCT00796653|147709163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947|STANDARD_ERROR_OF_MEAN|0.316||0.8594||95.0|0.493|1.82|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.820|0.493|0.8594
74077505|NCT00796653|147709163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.803|STANDARD_ERROR_OF_MEAN|0.281||0.5466||95.0|0.405|1.593|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.593|0.405|0.5466
74077506|NCT00796653|147709164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.807|STANDARD_ERROR_OF_MEAN|0.146||0.2494||95.0|0.566|1.15|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.150|0.566|0.2494
74077507|NCT00796653|147709164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.791|STANDARD_ERROR_OF_MEAN|0.143||0.2006||95.0|0.555|1.126|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.126|0.555|0.2006
74077508|NCT00796653|147709164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.903|STANDARD_ERROR_OF_MEAN|0.16||0.5795||95.0|0.637|1.279|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.279|0.637|0.5795
74077509|NCT00796653|147709165|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.785|STANDARD_ERROR_OF_MEAN|0.1342||0.1571||95.0|0.5613|1.0979|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.0979|0.5613|0.1571
74077510|NCT00796653|147709165|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8631|STANDARD_ERROR_OF_MEAN|0.1451||0.3814||95.0|0.6205|1.2005|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.2005|0.6205|0.3814
74077511|NCT00796653|147709165|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0631|STANDARD_ERROR_OF_MEAN|0.1748||0.7098||95.0|0.7699|1.468|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.4680|0.7699|0.7098
74077512|NCT00796653|147709166|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7925|STANDARD_ERROR_OF_MEAN|0.2952||0.5326||95.0|0.3814|1.6464|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.6464|0.3814|0.5326
74077513|NCT00796653|147709166|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0078|STANDARD_ERROR_OF_MEAN|0.356||0.9824||95.0|0.5038|2.016|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.0160|0.5038|0.9824
74077514|NCT00796653|147709166|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0403|STANDARD_ERROR_OF_MEAN|0.3681||0.9112||95.0|0.5194|2.0832|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||2.0832|0.5194|0.9112
74077515|NCT00796653|147709167|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.744|STANDARD_ERROR_OF_MEAN|0.1389||0.1136||95.0|0.5158|1.0733|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.0733|0.5158|0.1136
74077516|NCT00796653|147709167|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7842|STANDARD_ERROR_OF_MEAN|0.1449||0.1887||95.0|0.5456|1.1271|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.1271|0.5456|0.1887
74077517|NCT00796653|147709167|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.9761|STANDARD_ERROR_OF_MEAN|0.1747||0.8925||95.0|0.6869|1.387|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.3870|0.6869|0.8925
74077518|NCT00796653|147709170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.509|STANDARD_ERROR_OF_MEAN|0.23||0.027|TWO_SIDED|95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo||0.960|0.058|0.0270
74077519|NCT00796653|147709170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.525|STANDARD_ERROR_OF_MEAN|0.226||0.0203|TWO_SIDED|95.0|0.082|0.967|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo||0.967|0.082|0.0203
74077520|NCT00796653|147709170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.355|STANDARD_ERROR_OF_MEAN|0.226||0.1166|TWO_SIDED|95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo||0.799|-0.088|0.1166
74077521|NCT03393208|147709175|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LeastSquare(LS) Mean%|99.76|||||TWO_SIDED|90.0|92.84|107.2||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||107.20|92.84|
74077522|NCT03393208|147709175|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.67||||||90.0|91.25|106.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||106.69|91.25|
74077523|NCT03393208|147709176|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|99.62||||||90.0|92.69|106.77||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||106.77|92.69|
74077524|NCT03393208|147709176|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.5||||||90.0|93.72|109.92||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||109.92|93.72|
74077525|NCT03393208|147709177|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.0|||||TWO_SIDED|90.0|-0.25|0.25||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||0.25|-0.25|
74077526|NCT03393208|147709177|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.25||||||90.0|-0.25|0.5||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||0.50|-0.25|
74077527|NCT03393208|147709179|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.26||||||90.0|94.33|108.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||108.69|94.33|
74077528|NCT03393208|147709179|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.17|||||TWO_SIDED|90.0|91.61|105.21||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||105.21|91.61|
74077529|NCT01848938|147709192|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Linear Mixed Models analysis|||analysis between groups||||<0.001
74077530|NCT01848938|147709193|SUPERIORITY_OR_OTHER|||||||0.005|||||||Linear Mixed Models analysis|||analysis between groups||||0.005
74077531|NCT01848938|147709194|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.023
74077532|NCT01848938|147709196|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.001
74077533|NCT01848938|147709197|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||<0.001
73885512|NCT00129402|147304531|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
73885513|NCT00129402|147304532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0|||||ANOVA|||||||.95
73885514|NCT03044106|147304544|SUPERIORITY||Mean Difference (Final Values)|3.825|STANDARD_DEVIATION|3.308759||0.0068|TWO_SIDED|95.0|1.058809|6.591192|||t-test, 2 sided|||This is the difference between pre and post KEA in those receiving the active treatment with a history of hamstring strain.||6.591192|1.058809|0.0068
73885515|NCT03044106|147304544|SUPERIORITY||Median Difference (Final Values)|1.0|STANDARD_DEVIATION|3.431784||0.2185|TWO_SIDED|95.0|-1.869044|3.869044|||t-test, 2 sided|||This is the difference in pre /post KEA means after receiving the sham treatment in those with a history of hamstring strains.||3.869044|-1.869044|0.2185
73885516|NCT03044106|147304544|SUPERIORITY||Mean Difference (Final Values)|0.6638904|STANDARD_DEVIATION|3.450892||0.1281|TWO_SIDED|95.0|-0.5037233|1.831504|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the active treatment with no history of hamstring strain.||1.831504|-.5037233|0.1281
73885517|NCT03044106|147304544|SUPERIORITY||Mean Difference (Final Values)|2.688237|STANDARD_DEVIATION|3.241751||0|TWO_SIDED|95.0|1.557137|3.819337|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the sham treatment who have no history of hamstring strain.||3.819337|1.557137|0.00
74077534|NCT00207090|147709214|SUPERIORITY_OR_OTHER_LEGACY||Point estimate|0.912|||||TWO_SIDED|90.0|0.751|1.106||||||Two-way analyses of variance were performed on log-transformed values of Cmax. The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.||1.106|0.751|
73885518|NCT03044106|147304544|SUPERIORITY||Mean Difference (Final Values)|2.825||||0.09|TWO_SIDED|95.0|-0.4543|6.0581|||Mixed Models Analysis|||This is the mean difference in effect between active and sham in those with a history of hamstring strain||6.0581|-0.4543|0.090
73885519|NCT03044106|147304544|SUPERIORITY||Mean Difference (Final Values)|-2.024||||0.018|TWO_SIDED|95.0|-3.4474|-0.3406|||Mixed Models Analysis|||This is the mean difference of effect between active and sham in those without a history of hamstring strain.||-0.3406|-3.4474|0.018
73885520|NCT03199976|147304563|SUPERIORITY||||||<|0.01||||||Bonferroni correction was applied in pairwise analyses.|Wilcoxon (Mann-Whitney)|||||||<0.01
74077535|NCT00207090|147709215|SUPERIORITY_OR_OTHER_LEGACY||Point estimate|0.566|||||TWO_SIDED|90.0|0.482|0.664||||||Two-way analyses of variance were performed on log-transformed values of (AUC \[INF\]). The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.||0.664|0.482|
74077536|NCT00841698|147709238|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|97.34||||||90.0|91.67|103.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.35|91.67|
73885521|NCT03199976|147304564|SUPERIORITY|||||||0.595|||||||Chi-squared|||||||0.595
73885522|NCT03199976|147304565|SUPERIORITY||||||<|0.01||||||Bonferroni correction was applied in pairwise analyses.|Wilcoxon (Mann-Whitney)|||||||<0.01
73885523|NCT03199976|147304566|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
73885524|NCT00412984|147304623|SUPERIORITY|With an average 2.1 years follow-up and assuming a stroke rate of 1.20 per hundred patient-years, \~18,000 randomized subjects allocated in a 1:1 ratio to apixaban or warfarin group would be needed to achieve the desired power. These calculations assumed an incidence of 1% loss to follow-up. Non-inferiority for the primary efficacy endpoint will be assessed first. If non-inferiority (using a NI margin of 1.38) is demonstrated then, superiority for the primary efficacy endpoint will be tested|Hazard Ratio (HR)|0.79||||0.0114|TWO_SIDED|95.0|0.66|0.95||2-sided P-value for superiority test|Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status. (experienced, naïve).|apixaban / warfarin|With 448 subjects with confirmed strokes or systemic emboli, study would have at least 90% power to meet both regulatory definitions of non-inferiority described in the following: (1) the non-inferiority (NI) of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for relative risk (RR) was less than 1.38; (2) the NI of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 99% CI for RR was less than 1.44.||.95|.66|0.0114
73885525|NCT00412984|147304625|SUPERIORITY|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~1. superiority for the primary efficacy will be tested~2. if superiority for the primary efficacy is~   1. not demonstrated, stop~  2. demonstrated, then superiority for MB will be tested~3. if superiority for MB is~   1. not demonstrated, stop~  2. demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"|Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.6|0.8|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin|||0.80|0.60|<.0001
73885526|NCT00412984|147304627|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0465|TWO_SIDED|95.0|0.8|1.0|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~1. superiority for the primary efficacy will be tested~2. if superiority for the primary efficacy is~   1. not demonstrated, stop~  2. demonstrated, then superiority for MB will be tested~3. if superiority for MB is~   1. not demonstrated, stop~  2. demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"||1.00|0.80|0.0465
74077537|NCT00841698|147709239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.46||||||90.0|90.22|98.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.89|90.22|
73885527|NCT00412984|147304628|OTHER||Hazard Ratio (HR)|0.92||||0.422|TWO_SIDED|95.0|0.74|1.13||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Ischemic or Unspecified Stroke||1.13|0.74|0.4220
73885528|NCT00412984|147304628|OTHER||Hazard Ratio (HR)|0.51||||0.0006|TWO_SIDED|95.0|0.35|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Hemorrhagic Stroke||0.75|0.35|0.0006
74077538|NCT00841698|147709240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.83||||||90.0|89.96|99.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.96|89.96|
73885529|NCT00412984|147304628|OTHER||Hazard Ratio (HR)|0.87||||0.702|TWO_SIDED|95.0|0.44|1.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Systemic Embolism||1.75|0.44|0.7020
74077539|NCT00304187|147709245|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
74077540|NCT00099047|147709247|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|0.05||0.23|TWO_SIDED||||||SAS version 8||36 evaluable patients randomized 1:1 to each treatment was planned in order to have \>77% power to detect differences in above parameters equal to or greater than one standard deviation, based on a 2-sided Wilcoxon rank-sum test with .05 Type I error.|||||.23
74077541|NCT00651820|147709249|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Paired-Prentice Wilcoxon (PPW)|Time to complete wound closure Drug(T1)and Vehicle(T2)Hypothesis, Ho: T1=T2,using paired Prentice-Wilcoxon at significant level of 5%, 2-sided.||Each subject served as their own control, each receiving duplicate dermatome-induced wounds with 1 wound treated with active drug and the other treated with vehicle. Mean time to wound closure was calculated for the wounds treated with drug, the wounds treated with vehicle, and an over-all mean time to wound closure||||<0.05
74077542|NCT00651820|147709250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Stiffness: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments||||<0.05
74077543|NCT00651820|147709250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Energy Absorption: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments||||<0.05
74077544|NCT03374176|147709262|EQUIVALENCE||Mean Difference (Net)|0.05|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||chi-square|||<0.05
74077545|NCT01302548|147709267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0833|STANDARD_DEVIATION|0.8609||0.797|TWO_SIDED|95.0|-0.5738|0.7405||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 28||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."||.7405|-.5738|.7970
74077546|NCT01302548|147709268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2364||||0.3575|TWO_SIDED|95.0|0.0239|2.3394||This is unadjusted.|Fisher Exact|Cell (1,1) Frequency (F) = 13||"Ho: There is not a significant difference between the proportion of patients requiring antibiotics after the use of IRRISEPT solution vs. the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."||2.3394|.0239|.3575
73885530|NCT00412984|147304628|OTHER||Hazard Ratio (HR)|0.88||||0.372|TWO_SIDED|95.0|0.66|1.17||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Myocardial Infarction||1.17|0.66|0.3720
73885531|NCT00412984|147304629|OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding||0.86|0.69|<.0001
74077547|NCT01302548|147709269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.5477||0.5415|TWO_SIDED|95.0|-2.0659|1.2659||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 4||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing in patients that are MRSA positive.~This study did not enroll an adequate number of patients to meet sufficient power."||1.2659|-2.0659|.5415
74077548|NCT01249651|147709272|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.||||<0.001
74077549|NCT00787254|147709299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.251|||<|0.0001|TWO_SIDED|95.0|0.14|0.4499|||Log Rank|||||0.4499|0.1400|<0.0001
74077550|NCT00787254|147709300|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
74077551|NCT00787254|147709301|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0041
74077552|NCT00787254|147709302|SUPERIORITY_OR_OTHER|||||||0.0652||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0652
74077553|NCT00787254|147709303|SUPERIORITY_OR_OTHER|||||||0.9836||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9836
74077554|NCT00787254|147709305|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
74077555|NCT00787254|147709306|SUPERIORITY_OR_OTHER|||||||0.0161||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0161
74077556|NCT00787254|147709307|SUPERIORITY_OR_OTHER|||||||0.0068||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0068
74077557|NCT00787254|147709308|SUPERIORITY_OR_OTHER|||||||0.2363||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2363
74077558|NCT00787254|147709310|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
74077559|NCT00787254|147709311|SUPERIORITY_OR_OTHER|||||||0.4788||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4788
74077560|NCT00787254|147709312|SUPERIORITY_OR_OTHER|||||||0.6607||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6607
74077561|NCT00787254|147709313|SUPERIORITY_OR_OTHER|||||||0.8811||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8811
74077562|NCT00787254|147709314|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
74077563|NCT00787254|147709316|SUPERIORITY_OR_OTHER|||||||0.206||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2060
74077564|NCT00787254|147709317|SUPERIORITY_OR_OTHER|||||||0.5099||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5099
74077565|NCT00787254|147709318|SUPERIORITY_OR_OTHER|||||||0.7794||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7794
74077566|NCT00787254|147709319|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
74077567|NCT00787254|147709321|SUPERIORITY_OR_OTHER|||||||0.698||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6980
74077568|NCT00787254|147709322|SUPERIORITY_OR_OTHER|||||||0.4599||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4599
74077569|NCT00787254|147709323|SUPERIORITY_OR_OTHER|||||||0.0355||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0355
74077570|NCT00787254|147709324|SUPERIORITY_OR_OTHER|||||||0.7325||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7325
73885532|NCT00412984|147304629|OTHER||Hazard Ratio (HR)|0.89||||0.0192|TWO_SIDED|95.0|0.81|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / All-Cause Death||0.98|0.81|0.0192
73888556|NCT01929317|147309698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.1|1.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, Off status.|||1.8|-2.1|
74077571|NCT00787254|147709326|SUPERIORITY_OR_OTHER|||||||0.8262||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8262
74077572|NCT00787254|147709327|SUPERIORITY_OR_OTHER|||||||0.7244||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7244
74077573|NCT00787254|147709328|SUPERIORITY_OR_OTHER|||||||0.9566||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9566
74077574|NCT00787254|147709329|SUPERIORITY_OR_OTHER|||||||0.2008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2008
74077575|NCT00787254|147709331|SUPERIORITY_OR_OTHER|||||||0.0703||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0703
74077576|NCT00787254|147709332|SUPERIORITY_OR_OTHER|||||||0.3046||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3046
74077577|NCT00787254|147709333|SUPERIORITY_OR_OTHER|||||||0.7121||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7121
74077578|NCT00787254|147709334|SUPERIORITY_OR_OTHER|||||||0.1522||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1522
74077579|NCT00787254|147709336|SUPERIORITY_OR_OTHER|||||||0.5328||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5328
74077580|NCT00787254|147709337|SUPERIORITY_OR_OTHER|||||||0.7223||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7223
74077581|NCT00787254|147709338|SUPERIORITY_OR_OTHER|||||||0.3117||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3117
74077582|NCT00787254|147709339|SUPERIORITY_OR_OTHER|||||||0.4344||95.0|||||t-test, 2 sided|||||||0.4344
74077583|NCT00787254|147709341|SUPERIORITY_OR_OTHER|||||||0.1571||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1571
74077584|NCT00787254|147709342|SUPERIORITY_OR_OTHER|||||||0.2503||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2503
74077585|NCT00787254|147709343|SUPERIORITY_OR_OTHER|||||||0.4028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4028
74077586|NCT00787254|147709344|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
74077587|NCT00859430|147709347|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|105.0||||||90.0|98.6|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|98.6|
74077588|NCT00859430|147709348|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|96.2|
74077589|NCT00859430|147709349|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|95.9|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|95.9|
74077590|NCT04115293|147709350|SUPERIORITY||LS Mean Difference|-2.09|||<|0.001|TWO_SIDED|95.0|-3.24|-0.95|||MMRM ANCOVA|||||-0.95|-3.24|<0.001
74077591|NCT04115293|147709351|SUPERIORITY||LS Mean Difference|-2.94|||<|0.001|TWO_SIDED|95.0|-4.39|-1.49|||MMRM ANCOVA|||||-1.49|-4.39|<0.001
74077592|NCT04115293|147709352|SUPERIORITY||LS Mean Difference|-3.2||||0.0023|TWO_SIDED|95.0|-5.24|-1.16|||MMRM ANCOVA|||||-1.16|-5.24|0.0023
74077593|NCT04115293|147709353|SUPERIORITY||LS Mean Difference|-2.49||||0.0128|TWO_SIDED|95.0|-4.45|-0.54|||MMRM ANCOVA|||||-0.54|-4.45|0.0128
74077594|NCT04115293|147709355|SUPERIORITY||Odds Ratio (OR)|2.608||||0.0885|TWO_SIDED|95.0|0.866|7.86|||Regression, Logistic|||||7.860|0.866|0.0885
74077595|NCT04115293|147709356|SUPERIORITY||Odds Ratio (OR)|3.184|||<|0.001|TWO_SIDED|95.0|1.662|6.101|||Regression, Logistic|||||6.101|1.662|<0.001
74077596|NCT04115293|147709357|SUPERIORITY||Odds Ratio (OR)|2.865||||0.0012|TWO_SIDED|95.0|1.518|5.409|||Regression, Logistic|||||5.409|1.518|0.0012
74077597|NCT02925884|147709437|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Decreased Cognitive Functions.||||0.011
74077598|NCT02925884|147709437|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Eyestrain.||||<0.001
74077599|NCT02925884|147709437|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Physical Discomfort.||||0.009
74077600|NCT02925884|147709437|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Deceased Visual Function.||||<0.001
74077601|NCT02925884|147709437|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Poor Balance.||||0.28
74077602|NCT02925884|147709438|SUPERIORITY|||||||0.903|||||||Mixed Models Analysis|||||||0.903
74077603|NCT02925884|147709439|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Red Color Perception.||||0.009
73885533|NCT00412984|147304629|OTHER||Hazard Ratio (HR)|0.85||||0.0002|TWO_SIDED|95.0|0.78|0.92||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding / All-Cause Death||0.92|0.78|0.0002
74077604|NCT02925884|147709439|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Green Color Perception.||||0.446
74077605|NCT02925884|147709439|SUPERIORITY|||||||0.953|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Blue Color Perception.||||0.953
74077606|NCT02925884|147709440|SUPERIORITY|||||||0.266|||||||Mixed Models Analysis|||||||0.266
74077607|NCT02925884|147709441|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.424
73885534|NCT00412984|147304629|OTHER||Hazard Ratio (HR)|0.88||||0.0107|TWO_SIDED|95.0|0.8|0.97||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / MI / All-Cause Death||0.97|0.80|0.0107
74077608|NCT02925884|147709442|SUPERIORITY|||||||0.343|||||||Mixed Models Analysis|||||||0.343
74077609|NCT02925884|147709443|SUPERIORITY|||||||0.489|||||||Mixed Models Analysis|||||||0.489
74077610|NCT02925884|147709444|SUPERIORITY|||||||0.885|||||||Mixed Models Analysis|||||||0.885
74077611|NCT02925884|147709445|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
74077612|NCT02925884|147709446|SUPERIORITY|||||||0.359|||||||Mixed Models Analysis|||||||0.359
74077613|NCT02301975|147709451|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit PM FEV1 for FF/VI and FP/S was more than -100 milliliter (mL)|Least square mean change difference|0.019|||||TWO_SIDED|95.0|-0.011|0.049||||||||0.049|-0.011|
74077614|NCT02301975|147709451|OTHER||Least square mean change difference|0.123|||<|0.001|TWO_SIDED|95.0|0.093|0.153|||Mixed Models Analysis|||||0.153|0.093|<0.001
74077615|NCT02301975|147709451|OTHER||Least square mean change difference|0.104|||<|0.001|TWO_SIDED|95.0|0.074|0.134|||Mixed Models Analysis|||||0.134|0.074|<0.001
74077616|NCT02301975|147709452|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit for FF/VI and FP/S was more than -100 mL|Least square mean change difference|0.006|||||TWO_SIDED|95.0|-0.027|0.04||||||||0.040|-0.027|
74077617|NCT02301975|147709452|OTHER||Least square mean change difference|0.12|||<|0.001|TWO_SIDED|95.0|0.086|0.153|||Mixed Models Analysis|||||0.153|0.086|<0.001
74077618|NCT02301975|147709452|OTHER||Least square mean change difference|0.113|||<|0.001|TWO_SIDED|95.0|0.08|0.147|||Mixed Models Analysis|||||0.147|0.080|<0.001
74077619|NCT02301975|147709453|OTHER||Least square mean change difference|1.2|||||TWO_SIDED|95.0|-0.5|3.0||||||||3.0|-0.5|
74077620|NCT02301975|147709453|OTHER||Least square mean change difference|2.7||||0.002|TWO_SIDED|95.0|0.9|4.4|||ANCOVA|||||4.4|0.9|0.002
74077621|NCT02301975|147709453|OTHER||Least square mean change difference|1.4||||0.106|TWO_SIDED|95.0|-0.3|3.2|||ANCOVA|||||3.2|-0.3|0.106
74077622|NCT02301975|147709454|OTHER||Least square mean change difference|1.2|||||TWO_SIDED|95.0|-0.7|3.1||||||||3.1|-0.7|
74077623|NCT02301975|147709454|OTHER||Least square mean change difference|2.7||||0.004|TWO_SIDED|95.0|0.8|4.5|||ANCOVA|||||4.5|0.8|0.004
74077624|NCT02301975|147709454|OTHER||Least square mean change difference|1.5||||0.115|TWO_SIDED|95.0|-0.4|3.3|||ANCOVA|||||3.3|-0.4|0.115
74077625|NCT02301975|147709455|OTHER||Least square mean change difference|5.2|||||TWO_SIDED|95.0|1.1|9.4||||||||9.4|1.1|
74077626|NCT02301975|147709455|OTHER||Least square mean change difference|21.5|||<|0.001|TWO_SIDED|95.0|17.4|25.6|||ANCOVA|||||25.6|17.4|<0.001
74077627|NCT02301975|147709455|OTHER||Least square mean change difference|16.3|||<|0.001|TWO_SIDED|95.0|12.2|20.4|||ANCOVA|||||20.4|12.2|<0.001
74077628|NCT02301975|147709456|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.53|1.54||||||||1.54|0.53|
74077629|NCT02301975|147709456|OTHER||Odds Ratio (OR)|1.15||||0.595|TWO_SIDED|95.0|0.69|1.9|||Regression, Logistic|||||1.90|0.69|0.595
74077630|NCT02301975|147709456|OTHER||Odds Ratio (OR)|1.27||||0.372|TWO_SIDED|95.0|0.75|2.12|||Regression, Logistic|||||2.12|0.75|0.372
74077631|NCT02301975|147709457|OTHER||Least square mean change difference|5.0|||||TWO_SIDED|95.0|0.7|9.3||||||||9.3|0.7|
74077632|NCT02301975|147709457|OTHER||Least square mean change difference|19.2|||<|0.001|TWO_SIDED|95.0|14.9|23.5|||ANCOVA|||||23.5|14.9|<0.001
74077633|NCT02301975|147709457|OTHER||Least square mean change difference|14.2|||<|0.001|TWO_SIDED|95.0|9.9|18.5|||ANCOVA|||||18.5|9.9|<0.001
73885535|NCT00412984|147304629|OTHER||Hazard Ratio (HR)|0.9||||0.0432|TWO_SIDED|95.0|0.82|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Ischemic or Unspecified Stroke / All-Cause Death||1.00|0.82|0.0432
73885536|NCT00412984|147304629|OTHER||Hazard Ratio (HR)|0.88||||0.0167|TWO_SIDED|95.0|0.79|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Hemorrhagic Stroke / All-Cause Death||0.98|0.79|0.0167
73885537|NCT00412984|147304629|OTHER||Hazard Ratio (HR)|0.89||||0.0464|TWO_SIDED|95.0|0.8|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Systemic Embolism / All-Cause Death||1.00|0.80|0.0464
73885538|NCT00412984|147304629|OTHER||Hazard Ratio (HR)|0.89||||0.0253|TWO_SIDED|95.0|0.8|0.99||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Myocardial Infarction / All-Cause Death||0.99|0.80|0.0253
73885539|NCT00412984|147304631|OTHER||Hazard Ratio (HR)|0.8||||0.0098|TWO_SIDED|95.0|0.67|0.95||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite Stroke/Systemic Embolism/Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants||0.95|0.67|0.0098
73885540|NCT00412984|147304634|OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.61|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.75|0.61|<.0001
73885541|NCT00412984|147304636|OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.68|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.75|0.68|<.0001
73885542|NCT00412984|147304637|OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.35|0.6||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe GUSTO bleeding events||0.60|0.35|<.0001
73885543|NCT00412984|147304637|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.5|0.71||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe or Moderate GUSTO bleeding events||0.71|0.50|<.0001
73885544|NCT00412984|147304638|OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.7||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Major TIMI bleeding event||0.70|0.46|<.0001
74077634|NCT03086460|147709469|SUPERIORITY||Mean Difference (Final Values)|0.111|||<|0.001|TWO_SIDED|95.0|0.05|0.171|||ANCOVA|||"Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~The primary endpoint was analyzed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects and baseline as a covariate. The confidence intervals (CIs) and the p-values of the comparisons between each dose of CHF 1531 pMDI and Placebo at Day 14 were adjusted for multiplicity, based on the parametric simulation method of Edwards and Berry."||0.171|0.050|<0.001
74077635|NCT03086460|147709469|SUPERIORITY||Mean Difference (Final Values)|0.158|||<|0.001|TWO_SIDED|95.0|0.095|0.22|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.220|0.095|<0.001
73885545|NCT00412984|147304638|OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.54|0.75|||Cox Proportional Hazard Model||apixaban / warfarin|Major or Minor TIMI bleeding criteria||0.75|0.54|<.0001
73885546|NCT00412984|147304640|OTHER||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.65|0.83||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.83|0.65|<.0001
73885547|NCT04218240|147304646|SUPERIORITY|||||||0.05|||||||Chi-squared|1 degree of freedom||A nonparametric (Kruskal-Wallis) comparison of the two groups (p=0.049)||||.05
73885548|NCT04218240|147304647|OTHER|Chi-square analysis||||||0.27|||||||Chi-squared|||hypothesis: more people in active PGB/LFX will complete withdrawal CI = 95% P = 0.5||||0.27
73885549|NCT02435212|147304665|SUPERIORITY||Least squares mean|2.58|STANDARD_ERROR_OF_MEAN|2.803||0.3598|TWO_SIDED|95.0|-2.99|8.15|||ANCOVA|||||8.15|-2.99|0.3598
73885550|NCT02435212|147304666|SUPERIORITY||Least squares mean|176.36|STANDARD_ERROR_OF_MEAN|153.933||0.2546|TWO_SIDED|95.0|-129.0|481.72|||ANCOVA|||||481.72|-129.00|0.2546
73885551|NCT05179785|147304686|OTHER|||||||0.2938909|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.29389090
73885552|NCT05179785|147304686|OTHER|||||||0.97863544|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.97863544
73885553|NCT05179785|147304686|OTHER|||||||0.60236264|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.60236264
73885554|NCT05179785|147304686|OTHER|||||||0.35845126|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.35845126
74077636|NCT03086460|147709469|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.072|0.194|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.194|0.072|<0.001
74077637|NCT03086460|147709469|SUPERIORITY||Mean Difference (Final Values)|0.167|||<|0.001|TWO_SIDED|95.0|0.109|0.225|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.225|0.109|<0.001
74077638|NCT03086460|147709469|SUPERIORITY||Mean Difference (Final Values)|0.144|||<|0.001|TWO_SIDED|95.0|0.098|0.19|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate."||0.190|0.098|<0.001
74077639|NCT03086460|147709469|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.059|TWO_SIDED|95.0|-0.002|0.095|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate."||0.095|-0.002|0.059
74077640|NCT03086460|147709469|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.361|TWO_SIDED|95.0|-0.026|0.07|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.070|-0.026|0.361
74077641|NCT03086460|147709469|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.016|TWO_SIDED|95.0|0.011|0.102|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.102|0.011|0.016
74077642|NCT03086460|147709469|SUPERIORITY||Mean Difference (Final Values)|-0.025||||0.34|TWO_SIDED|95.0|-0.075|0.026|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.026|-0.075|0.340
74077643|NCT03086460|147709469|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.69|TWO_SIDED|95.0|-0.038|0.058|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.058|-0.038|0.690
74077644|NCT03086460|147709469|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.155|TWO_SIDED|95.0|-0.013|0.082|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.082|-0.013|0.155
74077645|NCT03086460|147709470|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.049|0.175|||ANCOVA|||"Comparison groups:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.175|0.049|<0.001
74077646|NCT03086460|147709470|SUPERIORITY||Mean Difference (Final Values)|0.166|||<|0.001|TWO_SIDED|95.0|0.101|0.23|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.230|0.101|<0.001
73885555|NCT05179785|147304686|OTHER|||||||0.91766025|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.91766025
73885556|NCT05179785|147304686|OTHER|||||||0.09605169|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delayed discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delayed discounting task"||||0.09605169
73885557|NCT05179785|147304687|OTHER|||||||0.50030946|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.50030946
73885558|NCT05179785|147304687|OTHER|||||||0.3751738|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.37517380
73885559|NCT05179785|147304687|OTHER|||||||0.47876971|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.47876971
73885560|NCT05179785|147304687|OTHER|||||||0.21798816|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21798816
73885561|NCT05179785|147304687|OTHER|||||||0.47876971|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.47876971
73885562|NCT05179785|147304687|OTHER|||||||0.21798816|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21798816
73885563|NCT05179785|147304688|OTHER|||||||0.75298499|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75298499
73885564|NCT05179785|147304688|OTHER|||||||0.16043787|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.16043787
73885565|NCT05179785|147304688|OTHER|||||||0.67902693|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.67902693
73885566|NCT05179785|147304688|OTHER|||||||0.33832977|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.33832977
73885567|NCT05179785|147304688|OTHER|||||||0.67902693|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.67902693
73885568|NCT05179785|147304688|OTHER|||||||0.33832977|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.33832977
73885569|NCT05179785|147304689|OTHER|||||||0.73357221|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.73357221
73885570|NCT05179785|147304689|OTHER|||||||0.43954526|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.43954526
73885571|NCT05179785|147304689|OTHER|||||||0.4419898|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.44198980
73885572|NCT05179785|147304689|OTHER|||||||0.39565784|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.39565784
73885573|NCT05179785|147304689|OTHER|||||||0.35602382|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.35602382
73885574|NCT05179785|147304689|OTHER|||||||0.30499144|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.30499144
73885575|NCT05179785|147304690|OTHER|||||||0.81601415|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.81601415
73885576|NCT05179785|147304690|OTHER|||||||0.20563452|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.20563452
73885577|NCT05179785|147304690|OTHER|||||||0.21947623|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21947623
73885578|NCT05179785|147304690|OTHER|||||||0.45535329|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.45535329
73885579|NCT05179785|147304690|OTHER|||||||0.21947623|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21947623
73885580|NCT05179785|147304690|OTHER|||||||0.45535329|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.45535329
73885581|NCT05179785|147304691|OTHER|||||||0.83462055|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.83462055
73885582|NCT05179785|147304691|OTHER|||||||0.21582586|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.21582586
73885583|NCT05179785|147304691|OTHER|||||||0.59574875|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.59574875
74077647|NCT03086460|147709470|SUPERIORITY||Mean Difference (Final Values)|0.138|||<|0.001|TWO_SIDED|95.0|0.074|0.203|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.203|0.074|<0.001
74077648|NCT03086460|147709470|SUPERIORITY||Mean Difference (Final Values)|0.174|||<|0.001|TWO_SIDED|95.0|0.113|0.235|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.235|0.113|<0.001
74077649|NCT03086460|147709470|SUPERIORITY||Mean Difference (Final Values)|0.149|||<|0.001|TWO_SIDED|95.0|0.101|0.197|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.197|0.101|<0.001
73885584|NCT05179785|147304691|OTHER|||||||0.75948776|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.75948776
73885585|NCT05179785|147304691|OTHER|||||||0.7238414|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.72384140
73885586|NCT05179785|147304691|OTHER|||||||0.00477281|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.00477281
73885587|NCT05179785|147304692|OTHER|||||||0.20047055|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.20047055
73885588|NCT05179785|147304692|OTHER|||||||0.77922802|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.77922802
73885589|NCT05179785|147304692|OTHER|||||||0.29196708|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.29196708
73885590|NCT05179785|147304692|OTHER|||||||0.05605962|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.05605962
73885591|NCT05179785|147304692|OTHER|||||||0.57368284|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.57368284
74077650|NCT03086460|147709470|SUPERIORITY||Mean Difference (Final Values)|0.054||||0.035|TWO_SIDED|95.0|0.004|0.104|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.104|0.004|0.035
74077651|NCT03086460|147709470|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.301|TWO_SIDED|95.0|-0.024|0.076|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.076|-0.024|0.301
74077652|NCT03086460|147709470|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.011|TWO_SIDED|95.0|0.014|0.11|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.110|0.014|0.011
74077653|NCT03086460|147709470|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.294|TWO_SIDED|95.0|-0.08|0.024|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.024|-0.080|0.294
74077654|NCT03086460|147709470|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.747|TWO_SIDED|95.0|-0.042|0.058|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.058|-0.042|0.747
74077655|NCT03086460|147709470|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.155|TWO_SIDED|95.0|-0.014|0.086|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.086|-0.014|0.155
74077656|NCT03086460|147709471|SUPERIORITY||Mean Difference (Final Values)|0.136|||<|0.001|TWO_SIDED|95.0|0.065|0.207|||ANCOVA|||"Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment, which occurred after the randomization error."||0.207|0.065|<0.001
74077657|NCT03086460|147709471|SUPERIORITY||Mean Difference (Final Values)|0.186|||<|0.001|TWO_SIDED|95.0|0.113|0.258|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.258|0.113|<0.001
74077658|NCT03086460|147709471|SUPERIORITY||Mean Difference (Final Values)|0.165|||<|0.001|TWO_SIDED|95.0|0.092|0.238|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.238|0.092|<0.001
74077659|NCT03086460|147709471|SUPERIORITY||Mean Difference (Final Values)|0.185|||<|0.001|TWO_SIDED|95.0|0.118|0.252|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.252|0.118|<0.001
73885592|NCT05179785|147304692|OTHER|||||||0.56397238|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.56397238
73885593|NCT05179785|147304693|OTHER|||||||0.86107891|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.86107891
73885594|NCT05179785|147304693|OTHER|||||||0.62228799|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.62228799
73885595|NCT05179785|147304693|OTHER|||||||0.79477883|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.79477883
73885596|NCT05179785|147304693|OTHER|||||||0.12634435|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.12634435
73885597|NCT05179785|147304693|OTHER|||||||0.79477883|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.79477883
73885598|NCT05179785|147304693|OTHER|||||||0.12634435|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.12634435
73885599|NCT05179785|147304693|OTHER|||||||0.62461968|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.62461968
73885600|NCT05179785|147304693|OTHER|||||||0.51324793|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.51324793
73885601|NCT05179785|147304693|OTHER|||||||0.60543603|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.60543603
73885602|NCT05179785|147304693|OTHER|||||||0.75565448|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75565448
73885603|NCT05179785|147304693|OTHER|||||||0.60543603|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.60543603
73885604|NCT05179785|147304693|OTHER|||||||0.75565448|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75565448
73885605|NCT05179785|147304694|OTHER|||||||0.09266386|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.09266386
73885606|NCT05179785|147304694|OTHER|||||||0.53980185|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.53980185
73885607|NCT05179785|147304694|OTHER|||||||0.30223686|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.30223686
73885608|NCT05179785|147304694|OTHER|||||||0.39166649|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.39166649
73885609|NCT05179785|147304694|OTHER|||||||0.30223686|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.30223686
73885610|NCT05179785|147304694|OTHER|||||||0.39166649|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.39166649
73885611|NCT05179785|147304695|OTHER|||||||0.0265|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.0265
73885612|NCT05179785|147304695|OTHER|||||||0.1053|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.1053
73885613|NCT05179785|147304695|OTHER|||||||0.0033|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.0033
73885614|NCT05966142|147304696|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.5913|TWO_SIDED|95.0|-0.42|0.74|||t-test, 2 sided|||||0.74|-0.42|0.5913
73885615|NCT05966142|147304697|SUPERIORITY|||||||0.6803|||||||t-test, 2 sided|||||||0.6803
73885616|NCT05966142|147304698|SUPERIORITY|||||||0.1228|||||||Chi-squared|||||||0.1228
73885617|NCT05966142|147304699|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.5252|TWO_SIDED|95.0|-1.7|0.9|||t-test, 2 sided|||||0.9|-1.7|0.5252
73885618|NCT05966142|147304700|SUPERIORITY|||||||0.9657|||||||Chi-squared|||||||0.9657
73888557|NCT01929317|147309698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.2|2.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, Off status.|||2.1|-2.2|
73885619|NCT04852302|147304705|EQUIVALENCE|We evaluated the same group to determine whether their reported depression was the same, worse, or better at 6-months compared to baseline.|Mean Difference (Net)|-1.81|STANDARD_DEVIATION|4.81||0.168|TWO_SIDED|95.0|-4.47|0.86||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||Null hypothesis was that the mean difference between the paired observations is zero.||0.86|-4.47|0.168
73885620|NCT04852302|147304706|EQUIVALENCE|We evaluated the same group to determine whether their reported depression was the same, worse, or better at 3-months compared to baseline.|Mean Difference (Net)|-0.3|STANDARD_DEVIATION|3.59||0.752|TWO_SIDED|95.0|-2.29|1.69||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||1.69|-2.29|0.752
73885621|NCT04852302|147304707|EQUIVALENCE|We evaluated the same group to determine whether their reported anxiety via the Death and Dying Distress Scale was the same, worse, or better at 3-months compared to baseline.|Mean Difference (Net)|-4.67|STANDARD_DEVIATION|16.26||0.285|TWO_SIDED|95.0|-13.67|4.34||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||4.34|-13.67|0.285
74077660|NCT03086460|147709471|SUPERIORITY||Mean Difference (Final Values)|0.176|||<|0.001|TWO_SIDED|95.0|0.121|0.231|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment which occurred after the randomization error."||0.231|0.121|<0.001
74077661|NCT03086460|147709471|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.088|TWO_SIDED|95.0|-0.008|0.108|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment which occurred after the randomization error."||0.108|-0.008|0.088
74077662|NCT03086460|147709471|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.323|TWO_SIDED|95.0|-0.029|0.088|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.088|-0.029|0.323
74077663|NCT03086460|147709471|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.073|TWO_SIDED|95.0|-0.005|0.103|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.103|-0.005|0.073
74077664|NCT03086460|147709471|SUPERIORITY||Mean Difference (Final Values)|-0.021||||0.489|TWO_SIDED|95.0|-0.08|0.039|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.039|-0.080|0.489
74077665|NCT03086460|147709471|SUPERIORITY||Median Difference (Final Values)|-0.001||||0.978|TWO_SIDED|95.0|-0.057|0.056|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.056|-0.057|0.978
74077666|NCT03086460|147709471|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.484|TWO_SIDED|95.0|-0.037|0.077|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.077|-0.037|0.484
74077667|NCT03086460|147709472|SUPERIORITY||Mean Difference (Final Values)|0.107|||<|0.001|TWO_SIDED|95.0|0.048|0.166|||ANCOVA|||"Comparison groups:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.166|0.048|<0.001
74077668|NCT03086460|147709472|SUPERIORITY||Mean Difference (Final Values)|0.157|||<|0.001|TWO_SIDED|95.0|0.096|0.217|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.217|0.096|<0.001
74077669|NCT03086460|147709472|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.073|0.193|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.193|0.073|<0.001
74077670|NCT03086460|147709472|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.103|0.217|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.217|0.103|<0.001
74077671|NCT03086460|147709472|SUPERIORITY||Mean Difference (Final Values)|0.147|||<|0.001|TWO_SIDED|95.0|0.102|0.192|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.192|0.102|<0.001
73885622|NCT04852302|147304707|EQUIVALENCE|We evaluated the same group to determine whether their reported anxiety via the Death and Dying Distress Scale was the same, worse, or better at 6-months compared to baseline.|Mean Difference (Net)|-2.2|STANDARD_DEVIATION|17.22||0.628|TWO_SIDED|95.0|-11.74|7.34||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||7.34|-11.74|0.628
74077672|NCT03086460|147709472|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.041|TWO_SIDED|95.0|0.002|0.098|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.098|0.002|0.041
74077673|NCT03086460|147709472|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.275|TWO_SIDED|95.0|-0.021|0.073|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.073|-0.021|0.275
74077674|NCT03086460|147709472|SUPERIORITY||Mean Difference (Final Values)|0.053||||0.021|TWO_SIDED|95.0|0.008|0.098|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.098|0.008|0.021
74077675|NCT03086460|147709472|SUPERIORITY||Mean Difference (Final Values)|-0.024||||0.35|TWO_SIDED|95.0|-0.073|0.026|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.026|-0.073|0.350
74077676|NCT03086460|147709472|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.886|TWO_SIDED|95.0|-0.044|0.051|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.051|-0.044|0.886
74077677|NCT03086460|147709472|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.254|TWO_SIDED|95.0|-0.02|0.074|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.074|-0.020|0.254
74077678|NCT03086460|147709473|SUPERIORITY||Mean Difference (Final Values)|0.114|||<|0.001|TWO_SIDED|95.0|0.06|0.169|||ANCOVA|||"Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.169|0.060|<0.001
74077679|NCT03086460|147709473|SUPERIORITY||Mean Difference (Final Values)|0.154|||<|0.001|TWO_SIDED|95.0|0.099|0.208|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.208|0.099|<0.001
74077680|NCT03086460|147709473|SUPERIORITY||Mean Difference (Final Values)|0.193|||<|0.001|TWO_SIDED|95.0|0.138|0.247|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.247|0.138|<0.001
74077681|NCT03086460|147709473|SUPERIORITY||Mean Difference (Final Values)|0.216|||<|0.001|TWO_SIDED|95.0|0.163|0.268|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.268|0.163|<0.001
74077682|NCT03086460|147709473|SUPERIORITY||Mean Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.12|0.224|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.224|0.120|<0.001
74077683|NCT03086460|147709473|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.165|TWO_SIDED|95.0|-0.016|0.095|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.016|0.165
74077684|NCT03086460|147709473|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.005|TWO_SIDED|95.0|0.024|0.132|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.132|0.024|0.005
74077685|NCT03086460|147709473|SUPERIORITY||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.049|0.153|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.153|0.049|<0.001
74077686|NCT03086460|147709473|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.187|TWO_SIDED|95.0|-0.019|0.097|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.097|-0.019|0.187
74077687|NCT03086460|147709473|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.028|TWO_SIDED|95.0|0.007|0.116|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.116|0.007|0.028
74077688|NCT03086460|147709473|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.406|TWO_SIDED|95.0|-0.031|0.076|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.076|-0.031|0.406
74077689|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.173|||<|0.001|TWO_SIDED|95.0|0.116|0.23|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.230|0.116|<0.001
73885623|NCT00135226|147304749|OTHER||Rate Ratio|0.88||||0.01|TWO_SIDED|95.0|0.79|0.97|||Log Rank|||||0.97|0.79|0.01
73885624|NCT00135226|147304749|OTHER||Rate Ratio|0.97||||0.55|TWO_SIDED|95.0|0.87|1.08|||Log Rank|||||1.08|0.87|0.55
73885625|NCT00135226|147304750|OTHER||Rate Ratio|1.29||||0.003|TWO_SIDED|95.0|1.09|1.52|||Log Rank|||||1.52|1.09|0.003
73885626|NCT00135226|147304751|OTHER||Rate Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.97||||||||0.97|0.80|
73885627|NCT00135226|147304751|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.91|1.09||||||||1.09|0.91|
73885628|NCT00135226|147304752|OTHER||Rate Ratio|0.99|||||TWO_SIDED|95.0|0.8|1.24||||||||1.24|0.80|
73885629|NCT00135226|147304753|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.85|1.04||||||||1.04|0.85|
73885630|NCT00135226|147304753|OTHER||Risk Ratio|0.95|||||TWO_SIDED|95.0|0.86|1.05||||||||1.05|0.86|
73885631|NCT00135226|147304754|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.12||||||||1.12|0.66|
73885632|NCT00135226|147304754|OTHER||Rate ratio|0.79|||||TWO_SIDED|95.0|0.61|1.02||||||||1.02|0.61|
73885633|NCT00135226|147304755|OTHER||Rate Ratio|1.12|||||TWO_SIDED|95.0|0.7|1.77||||||||1.77|0.7|
74077690|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.203|||<|0.001|TWO_SIDED|95.0|0.146|0.26|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.260|0.146|<0.001
74077691|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.223|||<|0.001|TWO_SIDED|95.0|0.166|0.28|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.280|0.166|<0.001
74077692|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.27|||<|0.001|TWO_SIDED|95.0|0.216|0.325|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.325|0.216|<0.001
74077693|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.241|||<|0.001|TWO_SIDED|95.0|0.187|0.295|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.295|0.187|<0.001
73885634|NCT00135226|147304755|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.59|1.5||||||||1.50|0.59|
73885635|NCT00135226|147304756|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.68|1.34||||||||1.34|0.68|
73885636|NCT00135226|147304756|OTHER||Rate Ratio|0.8|||||TWO_SIDED|95.0|0.57|1.12||||||||1.12|0.57|
73885637|NCT00135226|147304757|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15||||||||1.15|0.84|
73885638|NCT00135226|147304757|OTHER||Rate ratio|0.95|||||TWO_SIDED|95.0|0.82|1.12||||||||1.12|0.82|
73885639|NCT00135226|147304758|OTHER||Rate ratio|1.19|||||TWO_SIDED|95.0|0.86|1.63||||||||1.63|0.86|
73885640|NCT00135226|147304758|OTHER||Rate Ratio|0.93|||||TWO_SIDED|95.0|0.68|1.28||||||||1.28|0.68|
73885641|NCT00135226|147304759|OTHER||Rate Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.01||||||||1.01|0.64|
73885642|NCT00135226|147304759|OTHER||Rate Ratio|1.26|||||TWO_SIDED|95.0|1.0|1.59||||||||1.59|1.00|
73885643|NCT00135226|147304760|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.46|1.6||||||||1.60|0.46|
73885644|NCT00135226|147304760|OTHER||Rate ratio|0.77|||||TWO_SIDED|95.0|0.41|1.45||||||||1.45|0.41|
73885645|NCT00135226|147304761|OTHER||Rate Ratio|0.75|||||TWO_SIDED|95.0|0.17|3.3||||||||3.30|0.17|
73885646|NCT00135226|147304761|OTHER||Rate Ratio|0.75|||||TWO_SIDED|95.0|0.17|3.31||||||||3.31|0.17|
73885647|NCT00135226|147304762|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|0.92|1.11||||||||1.11|0.92|
73885648|NCT00135226|147304762|OTHER||Risk Ratio|1.0|||||TWO_SIDED|95.0|0.91|1.1||||||||1.10|0.91|
73885649|NCT00135226|147304763|OTHER||Rate Ratio|1.06|||||TWO_SIDED|95.0|0.78|1.43||||||||1.43|0.78|
73885650|NCT00135226|147304764|OTHER||Rate ratio|0.98|||||TWO_SIDED|95.0|0.74|1.29||||||||1.29|0.74|
73885651|NCT00135226|147304764|OTHER||Rate Ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||||1.37|0.79|
73885652|NCT00135226|147304765|OTHER||Rate Ratio|1.13|||||TWO_SIDED|95.0|0.97|1.32||||||||1.32|0.97|
73885653|NCT00135226|147304765|OTHER||Rate Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.25||||||||1.25|0.91|
73885654|NCT00135226|147304766|OTHER||Rate Ratio|1.02|||||TWO_SIDED|95.0|0.76|1.38||||||||1.38|0.76|
73885655|NCT00135226|147304766|OTHER||Rate Ratio|1.17|||||TWO_SIDED|95.0|0.87|1.58||||||||1.58|0.87|
73885656|NCT00135226|147304767|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|0.76|1.34||||||||1.34|0.76|
73885657|NCT00135226|147304767|OTHER||Rate Ratio|1.14|||||TWO_SIDED|95.0|0.86|1.52||||||||1.52|0.86|
73885658|NCT00135226|147304768|OTHER||Rate Ratio|0.85|||||TWO_SIDED|95.0|0.58|1.23||||||||1.23|0.58|
73885659|NCT00135226|147304768|OTHER||Rate ratio|1.02|||||TWO_SIDED|95.0|0.7|1.48||||||||1.48|0.70|
73885660|NCT00135226|147304769|OTHER||Rate Ratio|0.83|||||TWO_SIDED|95.0|0.49|1.41||||||||1.41|0.49|
73885661|NCT00135226|147304769|OTHER||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.42|1.22||||||||1.22|0.42|
73885662|NCT00135226|147304770|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.5|1.41||||||||1.41|0.50|
73885663|NCT00135226|147304770|OTHER||Rate Ratio|0.78|||||TWO_SIDED|95.0|0.46|1.31||||||||1.31|0.46|
73885664|NCT00135226|147304771|OTHER||Rate Ratio|1.23|||||TWO_SIDED|95.0|0.98|1.54||||||||1.54|0.98|
73885665|NCT00135226|147304772|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.63|1.12||||||||1.12|0.63|
73885666|NCT04531176|147304791|NON_INFERIORITY|The results of non-inferiority test results are between pairwise groups. Non-inferiority was tested at the 0.05 level at 1 year and performed pairwise with Bonferroni adjusted significance levels for each paired comparison.||||||0.004||||||The non-inferiority regions were set to be 1% for weight loss change. When both primary endpoints are non-inferior, superiority testing at the 0.025 overall error level with Bonferroni adjustment for each endpoint at 1 year was then performed.|t-test, 1 sided|||||||0.004
73885667|NCT04531176|147304792|NON_INFERIORITY|Non-inferiority was tested at the 0.05 level at 1 year and performed pairwise with Bonferroni adjusted significance levels for each paired comparison||||||0.05||||||The non-inferiority regions were set to be 0.5% for A1C. When both primary endpoints are non-inferior, superiority testing at the 0.025 overall error level with Bonferroni adjustment for each endpoint at 1 year was then performed.|t-test, 1 sided|||||||0.05
73885668|NCT00528112|147304793|SUPERIORITY_OR_OTHER||failure rate|0.009|||||TWO_SIDED|95.0|0.005|0.017||||||Cumulative failure rate (Kaplan-Meier) at 3 years||0.017|0.005|
73885669|NCT00528112|147304793|SUPERIORITY_OR_OTHER||failure rate|0.01||||||95.0|0.005|0.018||||||Cumulative failure rate (Kaplan-Meier) at 3 years||0.018|0.005|
73885670|NCT00528112|147304815|SUPERIORITY_OR_OTHER||failure rate|0.01445|||||TWO_SIDED|95.0|0.00823|0.02531||||||Cumulative failure rate (Kaplan-Meier) at 5 years||0.02531|0.00823|
73885671|NCT00894803|147304820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15||||0.053|TWO_SIDED|95.0|0.01|1.4|||Regression, Logistic|an exact logistic regression was used due to the number of events|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||1.40|0.01|0.053
73885672|NCT00894803|147304821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.23|TWO_SIDED|95.0|0.7|4.31|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.31|0.70|0.23
73885673|NCT00894803|147304821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.53|TWO_SIDED|95.0|0.51|3.71|||Regression, Logistic|adjusting for age, baseline NIHSS score and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.71|0.51|0.53
73885674|NCT00894803|147304823|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15||||0.053|TWO_SIDED|95.0|0.01|1.4|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||1.40|0.01|0.053
73885675|NCT00894803|147304824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.76||95.0|0.35|8.02|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||8.02|0.35|0.76
73885676|NCT00894803|147304825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.99999|TWO_SIDED|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to small number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.92|0.24|0.99999
74077694|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.308|TWO_SIDED|95.0|-0.028|0.089|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.089|-0.028|0.308
74077695|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.082|TWO_SIDED|95.0|-0.006|0.107|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.107|-0.006|0.082
73885677|NCT00894803|147304826|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.99999|TWO_SIDED|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.92|0.24|0.99999
73885678|NCT00894803|147304827|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.78|TWO_SIDED|95.0|0.38|5.76|||Regression, Logistic|Exact methods used due t number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.76|0.38|0.78
74077696|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.097|||<|0.001|TWO_SIDED|95.0|0.043|0.152|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.152|0.043|<0.001
74077697|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.52|TWO_SIDED|95.0|-0.041|0.08|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.080|-0.041|0.520
73885679|NCT00894803|147304828|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.99999|TWO_SIDED|95.0|0.26|4.18|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.18|0.26|0.99999
73885680|NCT00894803|147304829|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.35|TWO_SIDED|95.0|0.63|3.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.67|0.63|0.35
73885681|NCT00894803|147304829|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.85|TWO_SIDED|95.0|0.4|3.02|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.02|0.40|0.85
73885682|NCT00894803|147304830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.3|TWO_SIDED|95.0|0.65|3.88|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.88|0.65|0.30
73885683|NCT00894803|147304830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.73|TWO_SIDED|95.0|0.44|3.24|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.24|0.44|0.73
73885684|NCT00894803|147304831|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.31|TWO_SIDED|95.0|0.61|4.99|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.99|0.61|0.31
73885685|NCT00894803|147304832|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.55|TWO_SIDED|95.0|0.47|4.07|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.07|0.47|0.55
73885686|NCT00894803|147304833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.82|TWO_SIDED|95.0|0.46|2.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||2.67|0.46|0.82
73885687|NCT00894803|147304834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44||||0.07|TWO_SIDED|95.0|0.9|6.64|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||6.64|0.90|0.07
73885688|NCT00894803|147304834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.22|TWO_SIDED|95.0|0.67|5.88|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.88|0.67|0.22
73888558|NCT01929317|147309699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.7|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 2.|||0.4|-0.7|
73885689|NCT01345240|147304985|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the difference in percent seroprotection below 5% between recipients of licensed hepatitis B vaccine (Engerix-B) and recipients of RTS,S/AS01E vaccine.|Difference in percent seroprotection|-3.95|||||TWO_SIDED|95.0|-7.12|-2.16||||||Non-inferiority of the immune response to the hepatitis B antigen induced by RTS,S/AS01E vaccine versus a licensed hepatitis B vaccine.||-2.16|-7.12|
73885690|NCT01345240|147304988|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|0.91|||||TWO_SIDED|95.0|0.69|1.2|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.20|0.69|
73885691|NCT01345240|147304988|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|1.0|||||TWO_SIDED|95.0|0.76|1.32|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.32|0.76|
73885692|NCT01345240|147304988|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|1.1|||||TWO_SIDED|95.0|0.84|1.45|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.45|0.84|
73885693|NCT01345240|147304996|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.15|||||TWO_SIDED|95.0|0.95|1.39|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 1 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.39|0.95|
73885694|NCT01345240|147304996|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.2|||||TWO_SIDED|95.0|0.97|1.48|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 4 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.48|0.97|
74077698|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.067||||0.022|TWO_SIDED|95.0|0.01|0.124|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.124|0.010|0.022
73885695|NCT01345240|147304996|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.27|||||TWO_SIDED|95.0|1.06|1.52|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 5 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.52|1.06|
73885696|NCT01345240|147304996|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.17|||||TWO_SIDED|95.0|0.83|1.65|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 6B responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.65|0.83|
73885697|NCT01345240|147304996|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.94|1.33|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 7F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.33|0.94|
74077699|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.098|TWO_SIDED|95.0|-0.009|0.103|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.103|-0.009|0.098
73885698|NCT01345240|147304996|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.32|||||TWO_SIDED|95.0|1.08|1.63|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 9V responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.63|1.08|
73885699|NCT01345240|147304996|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.77|1.27|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 14 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.27|0.77|
73888559|NCT01929317|147309699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.7|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 4.|||0.6|-0.7|
74077700|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.153|||<|0.001|TWO_SIDED|95.0|0.095|0.21|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.210|0.095|<0.001
73885700|NCT01345240|147304996|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.81|||||TWO_SIDED|95.0|1.38|2.38|||ANOVA|||To demonstrate the non-inferiority of antibody against 18C responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||2.38|1.38|
73885701|NCT01345240|147304996|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.21|||||TWO_SIDED|95.0|0.89|1.65|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 19F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.65|0.89|
73885702|NCT01345240|147304996|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.81|1.55|||ANOVA|||To demonstrate the non-inferiority of antibody against 23F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.55|0.81|
73885703|NCT01345240|147305002|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.97|1.2|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertussis toxoid, (PT) of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.20|0.97|
73885704|NCT01345240|147305002|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.97|1.21|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, filamentous haemagglutinin (FHA), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.21|0.97|
73885705|NCT01345240|147305002|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.98|1.22|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertactin (anti-PRN), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.22|0.98|
74077701|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.131|0.249|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.249|0.131|<0.001
74077702|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.113|0.228|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.228|0.113|<0.001
74077703|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.217|||<|0.001|TWO_SIDED|95.0|0.162|0.272|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.272|0.162|<0.001
74077704|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.198|||<|0.001|TWO_SIDED|95.0|0.144|0.252|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.252|0.144|<0.001
73885706|NCT01345240|147305003|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 2, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the geometric mean concentrations (GMC) ratios of rotavirus antibodies (IgA) concentrations is below 2 for the rotavirus vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.11|||||TWO_SIDED|95.0|0.76|1.61|||ANOVA|||To demonstrate the non-inferiority of antibody response to the rotavirus vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen||1.61|0.76|
73885707|NCT01972217|147305088|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.017|TWO_SIDED|95.0|0.438|0.969|||Log Rank|||The 1-sided p-value provides a test for rejecting the null hypothesis of no treatment effect versus the superiority alternative that patients on olaparib have a lower risk of progression compared with placebo.||0.969|0.438|0.017
74077705|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.203|TWO_SIDED|95.0|-0.02|0.095|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.020|0.203
74077706|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.542|TWO_SIDED|95.0|-0.039|0.074|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.039|0.542
73885708|NCT01972217|147305101|OTHER||Odds Ratio (OR)|0.813||||0.309|TWO_SIDED|95.0|0.285|2.261||The p value was calculated with a 1-sided significance level of 2.5%.|Regression, Logistic|||||2.261|0.285|0.309
73885709|NCT01972217|147305102|OTHER||Hazard Ratio (HR)|0.781||||0.095|TWO_SIDED|95.0|0.54|1.13||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olapatib + abiraterone versus placebo + abiraterone: TFST||1.130|0.540|0.095
73885710|NCT01972217|147305102|OTHER||Hazard Ratio (HR)|0.809||||0.147|TWO_SIDED|95.0|0.545|1.201||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olaparib + abiraterone versus placebo + abiraterone: TSST||1.201|0.545|0.147
73885711|NCT01972217|147305103|OTHER||Hazard Ratio (HR)|0.911||||0.331|TWO_SIDED|95.0|0.6|1.384||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||||1.384|0.600|0.331
73885712|NCT01972217|147305104|OTHER||Hazard Ratio (HR)|0.788||||0.14|TWO_SIDED|95.0|0.511|1.215||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||||1.215|0.511|0.140
73885713|NCT02318706|147305105|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.03||||0.8773|TWO_SIDED|95.0|-0.35|0.3|||Mixed Models Analysis|||Week 14 change from baseline||0.30|-0.35|0.8773
73885714|NCT02318706|147305105|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.15||||0.3494|TWO_SIDED|95.0|-0.48|0.17|||Mixed Models Analysis|||Week 14 change from baseline||0.17|-0.48|0.3494
73885715|NCT02318706|147305105|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.5||||0.0027|TWO_SIDED|95.0|-0.82|-0.17|||Mixed Models Analysis|||Week 14 change from baseline||-0.17|-0.82|0.0027
73885716|NCT02798627|147305120|SUPERIORITY||||||=|0.97|||||||Chi-squared|||||||=0.97
74077707|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.064||||0.021|TWO_SIDED|95.0|0.01|0.119|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|0.010|0.021
74077708|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.51|TWO_SIDED|95.0|-0.08|0.04|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.040|-0.080|0.510
74077709|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.352|TWO_SIDED|95.0|-0.03|0.084|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.084|-0.030|0.352
74077710|NCT03086460|147709474|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.098|TWO_SIDED|95.0|-0.009|0.103|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.103|-0.009|0.098
73885717|NCT03821402|147305122|SUPERIORITY|||||||0.7645|||||||ANCOVA|||||||0.7645
74077711|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.181|||<|0.001|TWO_SIDED|95.0|0.122|0.241|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.241|0.122|<0.001
74077712|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.192|||<|0.001|TWO_SIDED|95.0|0.133|0.251|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.251|0.133|<0.001
73885718|NCT03821402|147305122|SUPERIORITY|||||||0.5509|||||||ANCOVA|||||||0.5509
73885719|NCT03821402|147305122|SUPERIORITY|||||||0.0488|||||||ANCOVA|||||||0.0488
73885720|NCT03821402|147305123|SUPERIORITY|||||||0.3698|||||||ANCOVA|||||||0.3698
73885721|NCT03821402|147305123|SUPERIORITY|||||||0.1972|||||||ANCOVA|||||||0.1972
73885722|NCT03821402|147305123|SUPERIORITY|||||||0.2037|||||||ANCOVA|||||||0.2037
73885723|NCT03821402|147305128|SUPERIORITY|||||||0.4324|||||||ANCOVA|||||||0.4324
73885724|NCT03821402|147305128|SUPERIORITY|||||||0.3893|||||||ANCOVA|||||||0.3893
73885725|NCT03821402|147305128|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
73885726|NCT03821402|147305129|SUPERIORITY|||||||0.0562|||||||ANCOVA|||||||0.0562
73885727|NCT03821402|147305129|SUPERIORITY|||||||0.015|||||||ANCOVA|||||||0.0150
73885728|NCT03821402|147305129|SUPERIORITY|||||||0.0092|||||||ANCOVA|||||||0.0092
73885729|NCT03175367|147305163|SUPERIORITY||Least Squares Mean Difference|-38.5|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|95.0|-56.5|-20.6|||Mixed Models Analysis|||||-20.6|-56.5|< .0001
73885730|NCT03175367|147305163|SUPERIORITY||Least Squares Mean Difference|-52.9|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-70.7|-35.1|||Mixed Models Analysis|||||-35.1|-70.7|< .0001
73885731|NCT03175367|147305163|SUPERIORITY||Least Squares Mean Difference|-56.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-73.7|-38.3|||Mixed Models Analysis|||||-38.3|-73.7|< .0001
73885732|NCT03175367|147305163|SUPERIORITY||Least Squares Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|9.3|=|0.0109|TWO_SIDED|95.0|-42.6|-5.7||P-Value is not adjusted for multiplicity|Mixed Models Analysis|||||-5.7|-42.6|= 0.0109
73885733|NCT03175367|147305163|SUPERIORITY||Least Squares Mean Difference|-50.5|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-68.4|-32.6|||Mixed Models Analysis|||||-32.6|-68.4|< .0001
73885734|NCT03175367|147305164|SUPERIORITY||Least Squares Mean Difference|-26.6|STANDARD_ERROR_OF_MEAN|7.2|=|0.0003|TWO_SIDED|95.0|-40.9|-12.4|||Mixed Models Analysis|||||-12.4|-40.9|= 0.0003
73885735|NCT03175367|147305164|SUPERIORITY||Least Squares Mean Difference|-42.0|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-56.1|-27.9|||Mixed Models Analysis|||||-27.9|-56.1|< 0.0001
74077713|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.215|||<|0.001|TWO_SIDED|95.0|0.156|0.275|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.275|0.156|<0.001
74077714|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.252|||<|0.001|TWO_SIDED|95.0|0.195|0.309|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.309|0.195|<0.001
74077715|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.238|||<|0.001|TWO_SIDED|95.0|0.182|0.295|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.295|0.182|<0.001
74077716|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.011||||0.723|TWO_SIDED|95.0|-0.049|0.071|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.071|-0.049|0.723
74077717|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.257|TWO_SIDED|95.0|-0.025|0.093|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.093|-0.025|0.257
74077718|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.016|TWO_SIDED|95.0|0.014|0.128|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.128|0.014|0.016
74077719|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.464|TWO_SIDED|95.0|-0.039|0.086|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.086|-0.039|0.464
74077720|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.048|TWO_SIDED|95.0|0.0|0.12|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.120|0.000|0.048
74077721|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.219|TWO_SIDED|95.0|-0.022|0.095|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.022|0.219
74077722|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.163|||<|0.001|TWO_SIDED|95.0|0.1|0.226|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.226|0.100|<0.001
74077723|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.126|0.254|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.254|0.126|<0.001
74077724|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.166|||<|0.001|TWO_SIDED|95.0|0.103|0.229|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.229|0.103|<0.001
74077725|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.206|||<|0.001|TWO_SIDED|95.0|0.146|0.266|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.266|0.146|<0.001
74077726|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.184|||<|0.001|TWO_SIDED|95.0|0.125|0.243|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.243|0.125|<0.001
74077727|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.4|TWO_SIDED|95.0|-0.036|0.09|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.090|-0.036|0.400
74077728|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.931|TWO_SIDED|95.0|-0.059|0.064|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.064|-0.059|0.931
74077729|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.16|TWO_SIDED|95.0|-0.017|0.102|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.102|-0.017|0.160
74077730|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|-0.024||||0.464|TWO_SIDED|95.0|-0.09|0.041|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.041|-0.090|0.464
74077731|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.623|TWO_SIDED|95.0|-0.047|0.078|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.078|-0.047|0.623
73885736|NCT03175367|147305164|SUPERIORITY||Least Squares Mean Difference|-45.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-59.5|-31.5|||Mixed Models Analysis|||||-31.5|-59.5|< 0.0001
73885737|NCT03175367|147305164|SUPERIORITY||Least Squares Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|6.6|=|0.0132|TWO_SIDED|95.0|-29.7|-3.5|||Mixed Models Analysis|||||-3.5|-29.7|= 0.0132
73885738|NCT03175367|147305164|SUPERIORITY||Least Squares Mean Difference|-39.4|STANDARD_ERROR_OF_MEAN|6.4|<|0.0001|TWO_SIDED|95.0|-52.0|-26.8|||Mixed Models Analysis|||||-26.8|-52.0|< 0.0001
73885739|NCT03175367|147305165|SUPERIORITY||Least Squares Mean Difference|-21.8|STANDARD_ERROR_OF_MEAN|8.4|=|0.0111|TWO_SIDED|95.0|-38.4|-5.1|||Mixed Models Analysis|||||-5.1|-38.4|= 0.0111
73885740|NCT03175367|147305165|SUPERIORITY||Least Squares Mean Difference|-40.4|STANDARD_ERROR_OF_MEAN|8.2|<|0.0001|TWO_SIDED|95.0|-56.7|-24.0|||Mixed Models Analysis|||||-24.0|-56.7|< 0.0001
73885741|NCT03175367|147305166|SUPERIORITY||Least Squares Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|-54.4|-24.3|||Mixed Models Analysis|||||-24.3|-54.4|< 0.0001
73885742|NCT03175367|147305166|SUPERIORITY||Least Squares Mean Difference|-53.8|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|-68.8|-38.9|||Mixed Models Analysis|||||-38.9|-68.8|< 0.0001
73885743|NCT03175367|147305166|SUPERIORITY||Least Squares Mean Difference|-58.5|STANDARD_ERROR_OF_MEAN|7.5|<|0.0001|TWO_SIDED|95.0|-73.4|-43.7|||Mixed Models Analysis|||||-43.7|-73.4|< 0.0001
73885744|NCT03175367|147305166|SUPERIORITY||Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|8.1|=|0.0042|TWO_SIDED|95.0|-39.7|-7.7|||Mixed Models Analysis|||||-7.7|-39.7|= 0.0042
74077732|NCT03086460|147709475|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.197|TWO_SIDED|95.0|-0.021|0.101|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.101|-0.021|0.197
74077733|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.098|TWO_SIDED|95.0|-0.01|0.113|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.113|-0.010|0.098
73885745|NCT03175367|147305166|SUPERIORITY||Least Squares Mean Difference|-50.9|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|95.0|-66.4|-35.4|||Mixed Models Analysis|||||-35.4|-66.4|< 0.0001
74077734|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.002|TWO_SIDED|95.0|0.035|0.159|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.159|0.035|0.002
74077735|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.002|TWO_SIDED|95.0|0.039|0.163|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.163|0.039|0.002
74077736|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.063|0.182|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.182|0.063|<0.001
74077737|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.054|0.171|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.171|0.054|<0.001
74077738|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.162|TWO_SIDED|95.0|-0.018|0.108|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.108|-0.018|0.162
73885746|NCT03175367|147305167|SUPERIORITY||Least Squares Mean Difference|-30.6|STANDARD_ERROR_OF_MEAN|9.7|=|0.0021|TWO_SIDED|95.0|-49.8|-11.4|||Mixed Models Analysis|||||-11.4|-49.8|= 0.0021
73885747|NCT03175367|147305167|SUPERIORITY||Least Squares Mean Difference|-54.6|STANDARD_ERROR_OF_MEAN|9.5|<|0.0001|TWO_SIDED|95.0|-73.4|-35.8|||Mixed Models Analysis|||||-35.8|-73.4|< 0.0001
73885748|NCT03175367|147305168|SUPERIORITY||Odds Ratio, log|19.4|||<|0.0001|TWO_SIDED|95.0|5.1|72.8|||Regression, Logistic|||||72.8|5.1|< 0.0001
73885749|NCT03175367|147305168|SUPERIORITY||Odds Ratio, log|23.9|||<|0.0001|TWO_SIDED|95.0|6.4|89.2|||Regression, Logistic|||||89.2|6.4|< 0.0001
73885750|NCT03175367|147305168|SUPERIORITY||Odds Ratio, log|22.1|||<|0.0001|TWO_SIDED|95.0|6.0|80.5|||Regression, Logistic|||||80.5|6.0|< 0.0001
73885751|NCT03175367|147305168|SUPERIORITY||Odds Ratio, log|8.5|||=|0.0007|TWO_SIDED|95.0|2.5|29.2|||Regression, Logistic|||||29.2|2.5|= 0.0007
73885752|NCT03175367|147305168|SUPERIORITY||Odds Ratio, log|42.3|||<|0.0001|TWO_SIDED|95.0|10.4|172.3|||Regression, Logistic|||||172.3|10.4|< 0.0001
73885753|NCT03175367|147305169|SUPERIORITY||Odds Ratio (OR)|9.6|||=|0.01|TWO_SIDED|95.0|1.7|53.5|||Regression, Logistic|||||53.5|1.7|= 0.0100
73885754|NCT03175367|147305169|SUPERIORITY||Odds Ratio (OR)|24.8|||=|0.0001|TWO_SIDED|95.0|4.7|129.9|||Regression, Logistic|||||129.9|4.7|= 0.0001
73885755|NCT03175367|147305169|SUPERIORITY||Odds Ratio (OR)|36.1|||<|0.0001|TWO_SIDED|95.0|6.7|194.7|||Regression, Logistic|||||194.7|6.7|< 0.0001
73885756|NCT03175367|147305169|SUPERIORITY||Odds Ratio (OR)|2.0|||=|0.3185|TWO_SIDED|95.0|0.5|8.2|||Regression, Logistic|||||8.2|0.5|= 0.3185
73885757|NCT03175367|147305169|SUPERIORITY||Odds Ratio (OR)|14.5|||<|0.0001|TWO_SIDED|95.0|3.9|54.2|||Regression, Logistic|||||54.2|3.9|< 0.0001
73885758|NCT03175367|147305170|SUPERIORITY||Odds Ratio (OR)|4.8|||=|0.0718|TWO_SIDED|95.0|0.9|26.5|||Regression, Logistic|||||26.5|0.9|= 0.0718
73885759|NCT03175367|147305170|SUPERIORITY||Odds Ratio (OR)|11.4|||=|0.0048|TWO_SIDED|95.0|2.1|62.1|||Regression, Logistic|||||62.1|2.1|= 0.0048
73885760|NCT03175367|147305170|SUPERIORITY||Odds Ratio (OR)|14.7|||=|0.0015|TWO_SIDED|95.0|2.8|76.8|||Regression, Logistic|||||76.8|2.8|= 0.0015
73885761|NCT03175367|147305170|SUPERIORITY||Odds Ratio (OR)|1.7|||=|0.527|TWO_SIDED|95.0|0.3|8.4|||Regression, Logistic|||||8.4|0.3|= 0.5270
73885762|NCT03175367|147305170|SUPERIORITY||Odds Ratio (OR)|7.7|||=|0.0047|TWO_SIDED|95.0|1.9|31.7|||Regression, Logistic|||||31.7|1.9|= 0.0047
73885763|NCT03175367|147305171|SUPERIORITY||Least Squares Mean Difference|-32.5|STANDARD_ERROR_OF_MEAN|11.5|=|0.0059|TWO_SIDED|95.0|-55.5|-9.6|||Mixed Models Analysis|||||-9.6|-55.5|= 0.0059
73885764|NCT03175367|147305171|SUPERIORITY||Least Squares Mean Difference|-54.5|STANDARD_ERROR_OF_MEAN|11.3|<|0.0001|TWO_SIDED|95.0|-77.0|-32.0|||Mixed Models Analysis|||||-32.0|-77.0|< 0.0001
73885765|NCT03175367|147305172|SUPERIORITY||Least Squares Mean Difference|-37.1|STANDARD_ERROR_OF_MEAN|5.7|<|0.0001|TWO_SIDED|95.0|-48.4|-25.8|||Mixed Models Analysis|||||-25.8|-48.4|< .0001
73885766|NCT03175367|147305172|SUPERIORITY||Least Squares Mean Difference|-46.4|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-57.5|-35.2|||Mixed Models Analysis|||||-35.2|-57.5|< .0001
73885767|NCT03175367|147305172|SUPERIORITY||Least Squares Mean Difference|-51.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-62.5|-40.4|||Mixed Models Analysis|||||-40.4|-62.5|< .0001
73885768|NCT03175367|147305172|SUPERIORITY||Least Squares Mean Difference|-22.2|STANDARD_ERROR_OF_MEAN|6.2|=|0.0006|TWO_SIDED|95.0|-34.6|-9.8|||Mixed Models Analysis|||||-9.8|-34.6|= 0.0006
74077739|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.117|TWO_SIDED|95.0|-0.012|0.11|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.110|-0.012|0.117
74077740|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.02|TWO_SIDED|95.0|0.011|0.13|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.130|0.011|0.020
74077741|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.909|TWO_SIDED|95.0|-0.062|0.07|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.070|-0.062|0.909
74077742|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.419|TWO_SIDED|95.0|-0.037|0.088|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.088|-0.037|0.419
74077743|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.483|TWO_SIDED|95.0|-0.039|0.083|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.083|-0.039|0.483
74077744|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.126|TWO_SIDED|95.0|-0.012|0.099|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.099|-0.012|0.126
74077745|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.012|TWO_SIDED|95.0|0.017|0.131|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.131|0.017|0.012
74077746|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.037|TWO_SIDED|95.0|0.004|0.116|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.116|0.004|0.037
74077747|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.003|TWO_SIDED|95.0|0.028|0.136|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.136|0.028|0.003
74077748|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.006|TWO_SIDED|95.0|0.021|0.127|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.127|0.021|0.006
73885769|NCT03175367|147305172|SUPERIORITY||Least Squares Mean Difference|-46.4|STANDARD_ERROR_OF_MEAN|6.1|<|0.0001|TWO_SIDED|95.0|-58.4|-34.4|||Mixed Models Analysis|||||-34.4|-58.4|< .0001
73885770|NCT03175367|147305173|SUPERIORITY||Least Squares Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|7.1|=|0.0001|TWO_SIDED|95.0|-42.6|-14.3|||Mixed Models Analysis|||||-14.3|-42.6|= 0.0001
73885771|NCT03175367|147305173|SUPERIORITY||Least Squares Mean Difference|-49.3|STANDARD_ERROR_OF_MEAN|7.0|<|0.0001|TWO_SIDED|95.0|-63.2|-35.4|||Mixed Models Analysis|||||-35.4|-63.2|< .0001
73885772|NCT03175367|147305174|SUPERIORITY||Adjusted Mean Difference|-46.1|STANDARD_ERROR_OF_MEAN|6.0|<|0.0001|TWO_SIDED|95.0|-57.8|-34.3|||Regression, Linear|||||-34.3|-57.8|< .0001
73885773|NCT03175367|147305174|SUPERIORITY||Adjusted Mean Difference|-55.8|STANDARD_ERROR_OF_MEAN|5.9|<|0.0001|TWO_SIDED|95.0|-67.3|-44.3|||Regression, Linear|||||-44.3|-67.3|< .0001
73885774|NCT03175367|147305174|SUPERIORITY||Adjusted Mean Difference|-61.5|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|95.0|-72.9|-50.0|||Regression, Linear|||||-50.0|-72.9|< .0001
73885775|NCT03175367|147305174|SUPERIORITY||Adjusted Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|6.5|=|0.0001|TWO_SIDED|95.0|-38.0|-12.4|||Regression, Linear|||||-12.4|-38.0|= 0.0001
73885776|NCT03175367|147305174|SUPERIORITY||Adjusted Mean Difference|-45.9|STANDARD_ERROR_OF_MEAN|6.3|<|0.0001|TWO_SIDED|95.0|-58.4|-33.5|||Regression, Linear|||||-33.5|-58.4|< .0001
73885777|NCT03175367|147305175|SUPERIORITY||Adjusted Mean Difference|-17.1|STANDARD_ERROR_OF_MEAN|7.5|=|0.0228|TWO_SIDED|95.0|-31.8|-2.4|||Regression, Linear|||||-2.4|-31.8|= 0.0228
73885778|NCT03175367|147305175|SUPERIORITY||Adjusted Mean Difference|-45.3|STANDARD_ERROR_OF_MEAN|7.3|<|0.0001|TWO_SIDED|95.0|-59.6|-31.0|||Regression, Linear|||||-31.0|-59.6|< .0001
73885779|NCT03175367|147305176|SUPERIORITY||Adjusted Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|5.7|=|0.0635|TWO_SIDED|95.0|-21.8|0.6|||Regression, Linear|||||0.6|-21.8|= 0.0635
73885780|NCT03175367|147305176|SUPERIORITY||Adjusted Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|5.5|=|0.0314|TWO_SIDED|95.0|-22.8|-1.1|||Regression, Linear|||||-1.1|-22.8|= 0.0314
73885781|NCT03175367|147305176|SUPERIORITY||Adjusted Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|5.5|=|0.0923|TWO_SIDED|95.0|-19.9|1.5|||Regression, Linear|||||1.5|-19.9|= 0.0923
73885782|NCT03175367|147305176|SUPERIORITY||Adjusted Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|5.3|=|0.0017|TWO_SIDED|95.0|-26.8|-6.2|||Regression, Linear|||||-6.2|-26.8|= 0.0017
73885783|NCT03175367|147305176|SUPERIORITY||Adjusted Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|4.9|=|0.0009|TWO_SIDED|95.0|-26.2|-6.8|||Regression, Linear|||||-6.8|-26.2|= 0.0009
73885784|NCT03175367|147305177|SUPERIORITY||Adjusted Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|5.8|=|0.0054|TWO_SIDED|95.0|-27.4|-4.7|||Regression, Linear|||||-4.7|-27.4|= 0.0054
73885785|NCT03175367|147305177|SUPERIORITY||Adjusted Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|5.5|=|0.0085|TWO_SIDED|95.0|-25.4|-3.7|||Regression, Linear|||||-3.7|-25.4|= 0.0085
73885786|NCT02151058|147305182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.659|STANDARD_ERROR_OF_MEAN|0.0999|<|0.001|TWO_SIDED|95.0|-0.8559|-0.4622||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.4622|-0.8559|<0.001
73885787|NCT02151058|147305182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.993|STANDARD_ERROR_OF_MEAN|0.1005|<|0.001|TWO_SIDED|95.0|-1.1909|-0.7946||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.7946|-1.1909|<0.001
74077749|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.282|TWO_SIDED|95.0|-0.025|0.087|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.087|-0.025|0.282
73885788|NCT02151058|147305182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.334|STANDARD_ERROR_OF_MEAN|0.0812|<|0.001|TWO_SIDED|95.0|-0.4937|-0.1737||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1737|-0.4937|<0.001
73885789|NCT02151058|147305183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.286|STANDARD_ERROR_OF_MEAN|0.0809|<|0.001|TWO_SIDED|95.0|-0.445|-0.1263||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1263|-0.4450|<0.001
73885790|NCT02151058|147305183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.328|STANDARD_ERROR_OF_MEAN|0.0811|<|0.001|TWO_SIDED|95.0|-0.4877|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1679|-0.4877|<0.001
73885791|NCT02151058|147305183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.0653||0.52|TWO_SIDED|95.0|-0.1709|0.0866||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0866|-0.1709|0.520
73885792|NCT02151058|147305184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.513|STANDARD_ERROR_OF_MEAN|0.0971|<|0.001|TWO_SIDED|95.0|-0.7043|-0.3217||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3217|-0.7043|<0.001
73885793|NCT02151058|147305184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.685|STANDARD_ERROR_OF_MEAN|0.0975|<|0.001|TWO_SIDED|95.0|-0.877|-0.4925||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.4925|-0.8770|<0.001
73885794|NCT02151058|147305184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|STANDARD_ERROR_OF_MEAN|0.0786||0.03|TWO_SIDED|95.0|-0.3268|-0.0168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0168|-0.3268|0.030
73885795|NCT02151058|147305185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.0369||0.026|TWO_SIDED|95.0|-0.1556|-0.0102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0102|-0.1556|0.026
73885796|NCT02151058|147305185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.118|STANDARD_ERROR_OF_MEAN|0.0372||0.002|TWO_SIDED|95.0|-0.1917|-0.0451||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0451|-0.1917|0.002
73885797|NCT02151058|147305185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.0297||0.234|TWO_SIDED|95.0|-0.094|0.0231||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0231|-0.0940|0.234
73885798|NCT02151058|147305186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.0568||0.002|TWO_SIDED|95.0|-0.2882|-0.0644||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0644|-0.2882|0.002
73885799|NCT02151058|147305186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|STANDARD_ERROR_OF_MEAN|0.0573|<|0.001|TWO_SIDED|95.0|-0.4638|-0.2378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.2378|-0.4638|<0.001
73885800|NCT02151058|147305186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.0458|<|0.001|TWO_SIDED|95.0|-0.2648|-0.0841||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0841|-0.2648|<0.001
73885801|NCT02151058|147305187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|STANDARD_ERROR_OF_MEAN|0.0631|<|0.001|TWO_SIDED|95.0|-0.3713|-0.1226||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||Treatment and baseline value as covariates.||-0.1226|-0.3713|<0.001
73885802|NCT02151058|147305187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.498|STANDARD_ERROR_OF_MEAN|0.0638|<|0.001|TWO_SIDED|95.0|-0.6236|-0.3722||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3722|-0.6236|<0.001
73885803|NCT02151058|147305187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.0511|<|0.001|TWO_SIDED|95.0|-0.3516|-0.1503||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1503|-0.3516|<0.001
74077750|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.554|TWO_SIDED|95.0|-0.039|0.072|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.072|-0.039|0.554
74077751|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.149|TWO_SIDED|95.0|-0.014|0.091|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.091|-0.014|0.149
73885804|NCT02151058|147305188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.124|STANDARD_ERROR_OF_MEAN|0.0372||0.001|TWO_SIDED|95.0|-0.197|-0.0504||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0504|-0.1970|0.001
73885805|NCT02151058|147305188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.168|STANDARD_ERROR_OF_MEAN|0.0373|<|0.001|TWO_SIDED|95.0|-0.2413|-0.0941||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0941|-0.2413|<0.001
74077752|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.636|TWO_SIDED|95.0|-0.072|0.044|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.044|-0.072|0.636
73885806|NCT02151058|147305188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.0301||0.145|TWO_SIDED|95.0|-0.1034|0.0152||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0152|-0.1034|0.145
73885807|NCT02151058|147305189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.0497|<|0.001|TWO_SIDED|95.0|-0.3282|-0.1321||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1321|-0.3282|<0.001
73885808|NCT02151058|147305189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.313|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.4113|-0.2141||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.2141|-0.4113|<0.001
74077753|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.775|TWO_SIDED|95.0|-0.047|0.063|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.063|-0.047|0.775
73885809|NCT02151058|147305189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.0404||0.042|TWO_SIDED|95.0|-0.1621|-0.0031||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0031|-0.1621|0.042
73888560|NCT01929317|147309699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.7|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 6.|||0.8|-0.7|
73885810|NCT02151058|147305190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.275|STANDARD_ERROR_OF_MEAN|0.0543|<|0.001|TWO_SIDED|95.0|-0.382|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1679|-0.3820|<0.001
73885811|NCT02151058|147305190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.464|STANDARD_ERROR_OF_MEAN|0.0548|<|0.001|TWO_SIDED|95.0|-0.5724|-0.3565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3565|-0.5724|<0.001
73885812|NCT02151058|147305190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.0442|<|0.001|TWO_SIDED|95.0|-0.2767|-0.1023||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1023|-0.2767|<0.001
73885813|NCT03829228|147305191|SUPERIORITY||Mean Difference (Net)|1.31|||<|0.0001|TWO_SIDED|95.0|0.62|2.01||The threshold for statistical significance was p=0.01|ANOVA||Treatment Difference= Visit5-Baseline|||2.01|0.62|<0.0001
73885814|NCT03829228|147305192|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p=0.01|Regression, Logistic|||||||<0.0001
73885815|NCT03829228|147305193|SUPERIORITY||Mean Difference (Net)|1.31|||<|0.0001|TWO_SIDED|95.0|0.64|1.98||The threshold for statistical significance was p=0.01|ANOVA||Treatment difference=Visit5-Baseline|||1.98|0.64|<0.0001
74077754|NCT03086460|147709476|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.425|TWO_SIDED|95.0|-0.032|0.077|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.077|-0.032|0.425
74077755|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.058|0.187|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.187|0.058|<0.001
74077756|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.085|0.215|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.215|0.085|<0.001
73885816|NCT03829228|147305194|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significant was p=0.01.|Regression, Logistic|||||||<0.0001
73885817|NCT01887327|147305202|OTHER||LS Mean Difference vs Placebo|-31.64|||=|2.1e-06|TWO_SIDED|95.0|-44.0|-19.283|||LS Mean Difference vs Placebo|||||-19.283|-44.000|=0.0000021
74077757|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.059|0.189|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.189|0.059|<0.001
74077758|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.18|||<|0.001|TWO_SIDED|95.0|0.118|0.242|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.242|0.118|<0.001
73885818|NCT01887327|147305202|OTHER||LS Mean Difference vs Placebo|-27.4|||=|2.6e-05|TWO_SIDED|95.0|-39.657|-15.142|||LS Mean Difference vs Placebo|||||-15.142|-39.657|=0.0000260
73885819|NCT03027609|147305206|SUPERIORITY|comparison between the treatment and placebo|Risk Difference (RD)|-5.54||||0.6154|TWO_SIDED|95.0|-21.9|10.8||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||||10.8|-21.9|0.6154
73885820|NCT03027609|147305207|SUPERIORITY||Risk Difference (RD)|4.01||||0.8426|TWO_SIDED|95.0|-18.5|10.5||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||Comparison between the treatment and placebo||10.5|-18.5|0.8426
73885821|NCT03027609|147305208|SUPERIORITY|comparison between the treatment and placebo|P value CMH|3.6||||0.3562|TWO_SIDED|95.0|-13.1|20.3||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||Comparison between the treatment and placebo||20.3|-13.1|0.3562
73885822|NCT03027609|147305209|SUPERIORITY|Comparison between the treatment and placebo|P value CMH|-2.81||||0.8472|TWO_SIDED|95.0|-18.9|13.2||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||||13.2|-18.9|0.8472
73885823|NCT03027609|147305210|SUPERIORITY||Mean Difference (Final Values)|22.3||||0.4616|TWO_SIDED|95.0|-16.2|60.6||Marginally statistically significant only if p\<0.1|Chi-squared|||Data for Day 14||60.6|-16.2|0.4616
73885824|NCT03027609|147305210|SUPERIORITY||Mean Difference (Final Values)|22.3||||0.4053|TWO_SIDED|95.0|-13.3|57.8||Data for Day 21|Chi-squared|||Data for Day 21||57.8|-13.3|0.4053
73885825|NCT03027609|147305211|SUPERIORITY||Mean Difference (Final Values)|38.1||||0.0833|TWO_SIDED|90.0|-14.8|90.9||Marginally statistically significant only if p\<0.1|Chi-squared|||Data for Day 14||90.9|-14.8|0.0833
73885826|NCT03027609|147305211|SUPERIORITY||Mean Difference (Net)|23.8||||0.5151|TWO_SIDED|90.0|-30.5|78.1||Data for Day 21|Chi-squared|Marginally statistically significant only if p\<0.1 Day 21||Data for Day 21||78.1|-30.5|0.5151
73885827|NCT01462370|147305216|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority margin is -3.7 units.|Difference in LS Means|0.89||||0.043|TWO_SIDED|95.0|0.03|1.76||A priori threshold for statistical significance = \<0.025 (one-sided).|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||With at least 128 participants, the study had a 92% power to establish that etoricoxib is noninferior to ibuprofen (null hypothesis). The power and sample size were based on the following assumptions: 1) an approximately 15% protocol violation rate, 2) a noninferiority margin of -3.7 units (etoricoxib minus ibuprofen), and 3) an intrapatient standard deviation of 8 units.||1.76|0.03|0.043
73885828|NCT01462370|147305217|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.2||||0.768|TWO_SIDED|95.0|-1.16|1.57||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||1.57|-1.16|0.768
73885829|NCT01462370|147305218|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.26||||0.007|TWO_SIDED|95.0|0.07|0.45||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.45|0.07|0.007
73885830|NCT01462370|147305219|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.36|||<|0.001|TWO_SIDED|95.0|0.17|0.54||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.54|0.17|<0.001
73885831|NCT01462370|147305220|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.371|TWO_SIDED|95.0|0.7|1.14||A priori threshold for statistical significance = \<0.05.|Regression, Cox|Adjusted for treatment, period, and baseline pain intensity.||||1.14|0.70|0.371
73885832|NCT01462370|147305221|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.051|TWO_SIDED|95.0|0.0|0.2||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.20|-0.00|0.051
73885833|NCT01462370|147305222|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference in LS Means|0.17||||0.019|TWO_SIDED|95.0|0.03|0.32||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.32|0.03|0.019
73885834|NCT01462370|147305224|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.21|||<|0.001|TWO_SIDED|95.0|0.1|0.31||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.31|0.10|<0.001
73885835|NCT01462370|147305225|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.28||||0.002|TWO_SIDED|95.0|0.1|0.45||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.45|0.10|0.002
73885836|NCT01462370|147305226|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.11||||0.011|TWO_SIDED|95.0|0.03|0.2||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.20|0.03|0.011
73885837|NCT01462370|147305227|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.26||||0.004|TWO_SIDED|95.0|0.08|0.44||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.44|0.08|0.004
73885838|NCT01462370|147305228|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.112|TWO_SIDED|95.0|0.9|2.87||A priori threshold for statistical significance = \<0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.||||2.87|0.90|0.112
73885839|NCT01462370|147305229|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.97||||0.019|TWO_SIDED|95.0|1.12|3.45||A priori threshold for statistical significance = \<0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.||||3.45|1.12|0.019
73885840|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.0187|=|0.02|TWO_SIDED|90.0|0.008|0.069|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo' at 1 hour||0.069|0.008|=0.020
73885841|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.0227|<|0.001|TWO_SIDED|90.0|0.101|0.176|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour||0.176|0.101|<0.001
73885842|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|90.0|0.087|0.158|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour||0.158|0.087|<0.001
73885843|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.0185|=|0.22|TWO_SIDED|90.0|-0.016|0.045|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour||0.045|-0.016|=0.220
73885844|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|90.0|0.087|0.161|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour||0.161|0.087|<0.001
73885845|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.0214|<|0.001|TWO_SIDED|90.0|0.105|0.176|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour||0.176|0.105|<0.001
73885846|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.0188||0.155|TWO_SIDED|90.0|-0.012|0.05|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour||0.050|-0.012|0.155
73885847|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.0229|<|0.001|TWO_SIDED|90.0|0.053|0.129|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 12 hour||0.129|0.053|<0.001
74077759|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.177|||<|0.001|TWO_SIDED|95.0|0.115|0.238|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.238|0.115|<0.001
74077760|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.41|TWO_SIDED|95.0|-0.039|0.094|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.094|-0.039|0.410
74077761|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.961|TWO_SIDED|95.0|-0.063|0.066|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.066|-0.063|0.961
74077762|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.07|TWO_SIDED|95.0|-0.005|0.119|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|-0.005|0.070
74077763|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.454|TWO_SIDED|95.0|-0.095|0.043|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.043|-0.095|0.454
74077764|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.37|TWO_SIDED|95.0|-0.035|0.095|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.035|0.370
74077765|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.056||||0.086|TWO_SIDED|95.0|-0.008|0.12|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.120|-0.008|0.086
74077766|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.086||||0.011|TWO_SIDED|95.0|0.02|0.151|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.151|0.020|0.011
74077767|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.005|TWO_SIDED|95.0|0.029|0.164|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.164|0.029|0.005
74077768|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.01|TWO_SIDED|95.0|0.021|0.153|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.153|0.021|0.010
74077769|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.145|||<|0.001|TWO_SIDED|95.0|0.081|0.208|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.208|0.081|<0.001
74077770|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.127|||<|0.001|TWO_SIDED|95.0|0.065|0.189|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.189|0.065|<0.001
74077771|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.011||||0.74|TWO_SIDED|95.0|-0.055|0.078|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.078|-0.055|0.740
74077772|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.973|TWO_SIDED|95.0|-0.064|0.066|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.066|-0.064|0.973
74077773|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.064|TWO_SIDED|95.0|-0.003|0.122|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.122|-0.003|0.064
73885848|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|90.0|0.09|0.162|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour||0.162|0.090|<0.001
73885849|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.019||0.188|TWO_SIDED|90.0|-0.015|0.048|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour||0.048|-0.015|0.188
73885850|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.023|=|0.009|TWO_SIDED|90.0|0.017|0.093|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour||0.093|0.017|=0.009
73885851|NCT00674817|147305240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|90.0|0.086|0.159|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour||0.159|0.086|<0.001
73885852|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.0616|=|0.856|TWO_SIDED|90.0|-0.168|0.036|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 1 hour||0.036|-0.168|=0.856
73885853|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.0496|=|0.033|TWO_SIDED|90.0|0.01|0.174|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour||0.174|0.010|=0.033
73885854|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.0523|=|0.099|TWO_SIDED|90.0|-0.019|0.154|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour||0.154|-0.019|=0.099
74077774|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.774|TWO_SIDED|95.0|-0.079|0.059|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.059|-0.079|0.774
74077775|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.151|TWO_SIDED|95.0|-0.018|0.113|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.113|-0.018|0.151
74077776|NCT03086460|147709477|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.076|TWO_SIDED|95.0|-0.006|0.122|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.122|-0.006|0.076
74077777|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.003|TWO_SIDED|95.0|0.039|0.19|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.190|0.039|0.003
74077778|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.13|||<|0.001|TWO_SIDED|95.0|0.055|0.206|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.206|0.055|<0.001
73885855|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.067|STANDARD_ERROR_OF_MEAN|0.0612|=|0.862|TWO_SIDED|90.0|-0.168|0.034|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour||0.034|-0.168|=0.862
73885856|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.0493|=|0.008|TWO_SIDED|90.0|0.039|0.201|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour||0.201|0.039|=0.008
73885857|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.0516||0.027|TWO_SIDED|90.0|0.015|0.185|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour||0.185|0.015|0.027
73885858|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.0621|=|0.2|TWO_SIDED|90.0|-0.05|0.155|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour||0.155|-0.050|=0.200
73885859|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.05|=|0.031|TWO_SIDED|90.0|0.011|0.177|||Mix model|||GSK961081 1200 mcg Plus SAL versus that due to GSK961081 1200 mcg plus Placebo at 12 hour||0.177|0.011|=0.031
73885860|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.053|=|0.043|TWO_SIDED|90.0|0.004|0.179|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour||0.179|0.004|=0.043
73885861|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.0625|=|0.637|TWO_SIDED|90.0|-0.125|0.081|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour||0.081|-0.125|=0.637
73885862|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.05|=|0.004|TWO_SIDED|90.0|0.053|0.218|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour||0.218|0.053|=0.004
73885863|NCT00674817|147305241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.0534|=|0.031|TWO_SIDED|90.0|0.012|0.189|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour||0.189|0.012|=0.031
73885864|NCT00674817|147305247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.747|STANDARD_ERROR_OF_MEAN|2.1768|||TWO_SIDED|95.0|-0.547|8.041||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||8.041|-0.547|
73885865|NCT00674817|147305247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.712|STANDARD_ERROR_OF_MEAN|2.1453|||TWO_SIDED|95.0|-2.521|5.944||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-4 hours||5.944|-2.521|
73885866|NCT00674817|147305247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.755|STANDARD_ERROR_OF_MEAN|2.1869|||TWO_SIDED|95.0|-2.559|6.069||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-4 hours||6.069|-2.559|
73885867|NCT00674817|147305247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.231|STANDARD_ERROR_OF_MEAN|2.197|||TWO_SIDED|95.0|-5.565|3.103||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||3.103|-5.565|
74077779|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.137|||<|0.001|TWO_SIDED|95.0|0.061|0.213|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.213|0.061|<0.001
74077780|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.151|||<|0.001|TWO_SIDED|95.0|0.078|0.223|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.223|0.078|<0.001
74077781|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.168|||<|0.001|TWO_SIDED|95.0|0.097|0.24|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.240|0.097|<0.001
74077782|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.679|TWO_SIDED|95.0|-0.061|0.093|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.093|-0.061|0.679
74077783|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.549|TWO_SIDED|95.0|-0.052|0.098|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.098|-0.052|0.549
74077784|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.323|TWO_SIDED|95.0|-0.036|0.109|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.109|-0.036|0.323
74077785|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.866|TWO_SIDED|95.0|-0.073|0.087|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.087|-0.073|0.866
74077786|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.596|TWO_SIDED|95.0|-0.055|0.096|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.096|-0.055|0.596
74077787|NCT03086460|147709478|SUPERIORITY|"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."|Mean Difference (Final Values)|0.014||||0.72|TWO_SIDED|95.0|-0.061|0.088|||ANCOVA|||||0.088|-0.061|0.720
74077788|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.003|TWO_SIDED|95.0|0.038|0.185|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.185|0.038|0.003
74077789|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.209|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.209|0.057|<0.001
74077790|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.106||||0.005|TWO_SIDED|95.0|0.032|0.18|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.180|0.032|0.005
74077791|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.152|||<|0.001|TWO_SIDED|95.0|0.081|0.223|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.223|0.081|<0.001
74077792|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.072|0.212|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.212|0.072|<0.001
74077793|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.573|TWO_SIDED|95.0|-0.053|0.096|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.096|-0.053|0.573
74077794|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.881|TWO_SIDED|95.0|-0.078|0.067|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.067|-0.078|0.881
74077795|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.261|TWO_SIDED|95.0|-0.03|0.11|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.110|-0.030|0.261
74077796|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|-0.027||||0.493|TWO_SIDED|95.0|-0.104|0.051|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.051|-0.104|0.493
74077797|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.616|TWO_SIDED|95.0|-0.055|0.092|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.092|-0.055|0.616
74077798|NCT03086460|147709478|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.212|TWO_SIDED|95.0|-0.026|0.118|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.118|-0.026|0.212
74077799|NCT03086460|147709479|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.361|TWO_SIDED|95.0|-0.039|0.106|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.106|-0.039|0.361
74077800|NCT03086460|147709479|SUPERIORITY||Mean Difference (Final Values)|0.065||||0.085|TWO_SIDED|95.0|-0.009|0.138|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.138|-0.009|0.085
74077801|NCT03086460|147709479|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.328|TWO_SIDED|95.0|-0.037|0.109|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.109|-0.037|0.328
74077802|NCT03086460|147709479|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.002|TWO_SIDED|95.0|0.042|0.182|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.182|0.042|0.002
74077803|NCT03086460|147709479|SUPERIORITY||Mean Difference (Final Values)|0.089||||0.011|TWO_SIDED|95.0|0.02|0.158|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.158|0.020|0.011
74077804|NCT03086460|147709479|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.404|TWO_SIDED|95.0|-0.042|0.104|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.104|-0.042|0.404
74077805|NCT03086460|147709479|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.942|TWO_SIDED|95.0|-0.069|0.074|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.069|0.942
74077806|NCT03086460|147709479|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.027|TWO_SIDED|95.0|0.009|0.147|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.147|0.009|0.027
74077807|NCT03086460|147709479|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.463|TWO_SIDED|95.0|-0.104|0.048|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.048|-0.104|0.463
74077808|NCT03086460|147709479|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.2|TWO_SIDED|95.0|-0.025|0.119|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|-0.025|0.200
74077809|NCT03086460|147709479|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.037|TWO_SIDED|95.0|0.005|0.146|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.146|0.005|0.037
74077810|NCT03086460|147709480|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.896|TWO_SIDED|95.0|-0.083|0.073|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.073|-0.083|0.896
74077811|NCT03086460|147709480|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.81|TWO_SIDED|95.0|-0.089|0.07|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.070|-0.089|0.810
74077812|NCT03086460|147709480|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.882|TWO_SIDED|95.0|-0.084|0.073|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.073|-0.084|0.882
74077813|NCT03086460|147709480|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.115|TWO_SIDED|95.0|-0.015|0.136|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.136|-0.015|0.115
74077814|NCT03086460|147709480|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.111|TWO_SIDED|95.0|-0.014|0.134|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.134|-0.014|0.111
74077815|NCT03086460|147709480|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.911|TWO_SIDED|95.0|-0.083|0.074|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.083|0.911
74077816|NCT03086460|147709480|SUPERIORITY||Mean Difference (Final Values)|-0.001||||0.985|TWO_SIDED|95.0|-0.078|0.077|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.077|-0.078|0.985
74077817|NCT03086460|147709480|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.084|TWO_SIDED|95.0|-0.009|0.14|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.140|-0.009|0.084
74077818|NCT03086460|147709480|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.928|TWO_SIDED|95.0|-0.078|0.086|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.086|-0.078|0.928
74077819|NCT03086460|147709480|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.078|TWO_SIDED|95.0|-0.008|0.148|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.148|-0.008|0.078
74077820|NCT03086460|147709480|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.089|TWO_SIDED|95.0|-0.01|0.143|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.143|-0.010|0.089
74077821|NCT03086460|147709481|SUPERIORITY||Hazard Ratio (HR)|18.01|||<|0.001|TWO_SIDED|95.0|4.25|76.37|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Time to onset of action was analyzed using a Cox proportional hazard model stratified by patient, including treatment and period as a factor, and baseline FEV1 as covariate.~For patients receiving the same treatment twice, the analysis includes only data from the first instance of each treatment."||76.37|4.25|<0.001
74077822|NCT03086460|147709481|SUPERIORITY||Hazard Ratio (HR)|31.67|||<|0.001|TWO_SIDED|95.0|7.52|133.47|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||133.47|7.52|<0.001
74077823|NCT03086460|147709481|SUPERIORITY||Hazard Ratio (HR)|44.24|||<|0.001|TWO_SIDED|95.0|10.23|191.34|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||191.34|10.23|<0.001
74077824|NCT03086460|147709481|SUPERIORITY||Hazard Ratio (HR)|40.32|||<|0.001|TWO_SIDED|95.0|9.54|170.45|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||170.45|9.54|<0.001
74077825|NCT03086460|147709481|SUPERIORITY||Hazard Ratio (HR)|22.91|||<|0.001|TWO_SIDED|95.0|5.7|92.06|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||92.06|5.70|<0.001
74077826|NCT03086460|147709481|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.195|TWO_SIDED|95.0|0.75|4.13|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||4.13|0.75|0.195
74077827|NCT03086460|147709481|SUPERIORITY||Risk Ratio (RR)|2.46||||0.037|TWO_SIDED|95.0|1.06|5.72|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||5.72|1.06|0.037
74077828|NCT03086460|147709481|SUPERIORITY||Hazard Ratio (HR)|2.24||||0.042|TWO_SIDED|95.0|1.03|4.86|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||4.86|1.03|0.042
74077829|NCT03086460|147709481|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.435|TWO_SIDED|95.0|0.6|3.23|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||3.23|0.60|0.435
74077830|NCT03086460|147709481|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.564|TWO_SIDED|95.0|0.56|2.89|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||2.89|0.56|0.564
74077831|NCT03086460|147709481|SUPERIORITY|"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."|Hazard Ratio (HR)|0.91||||0.818|TWO_SIDED|95.0|0.41|2.01|||Regression, Cox|||||2.01|0.41|0.818
74077832|NCT00835575|147709493|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.52||||||90.0|92.84|106.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.69|92.84|
74077833|NCT00835575|147709494|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.59||||||90.0|99.13|108.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.25|99.13|
74077834|NCT00835575|147709495|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.87||||||90.0|99.47|108.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.46|99.47|
74077835|NCT01609257|147709508|SUPERIORITY_OR_OTHER|||||||0.674||||||No multiplicity adjustment.|Fisher Exact|||||||0.674
74077836|NCT01609257|147709515|SUPERIORITY_OR_OTHER|||||||0.001||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||||||0.001
74077837|NCT01609257|147709516|SUPERIORITY_OR_OTHER|||||||0.008||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 1||||0.008
74077838|NCT01609257|147709516|SUPERIORITY_OR_OTHER|||||||0.037||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 2||||0.037
74077839|NCT01609257|147709517|SUPERIORITY_OR_OTHER|||||||0.199|||||||Wilcoxon (Mann-Whitney)|||||||0.199
74077840|NCT01609257|147709518|SUPERIORITY_OR_OTHER|||||||0.562||||||Comparison of % Positive|Fisher Exact|||Any Day 1 to 30||||0.562
74077841|NCT02125461|147709541|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.42|0.65|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.65|0.42|<0.0001
74077842|NCT02125461|147709542|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.00251|TWO_SIDED|95.0|0.53|0.87|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.87|0.53|0.00251
74077843|NCT02125461|147709543|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Analysis performed using Fisher's exact test with mid p-value modification by subtracting half of the probability of the observed table from Fisher's p-value.||||<0.001
74077844|NCT02125461|147709547|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.68|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.68|0.41|<0.0001
74077845|NCT02125461|147709548|SUPERIORITY|||||||0.005||||||P-value generated based on z-test where z-test statistic is the ratio of the log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by the square root of the variance.|z-test|The variance was estimated using the delta method and Greenwood's formula.||||||0.005
74077846|NCT02125461|147709549|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.73|0.46|<0.0001
74077847|NCT02125461|147709550|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.664|TWO_SIDED|95.0|0.77|1.18||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.18|0.77|0.664
74077848|NCT02125461|147709551|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.522|TWO_SIDED|95.0|0.88|1.29||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for dyspnea. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.29|0.88|0.522
73885868|NCT00674817|147305248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.558|STANDARD_ERROR_OF_MEAN|2.7064|||TWO_SIDED|95.0|-0.781|9.897||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-27 hours||9.897|-0.781|
73885869|NCT00674817|147305248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.266|STANDARD_ERROR_OF_MEAN|2.6691|||TWO_SIDED|95.0|-2.999|7.532||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-27 hours||7.532|-2.999|
73885870|NCT00674817|147305248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|2.717|||TWO_SIDED|95.0|-4.429|6.29||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-27 hours||6.290|-4.429|
73885871|NCT00674817|147305248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.152|STANDARD_ERROR_OF_MEAN|2.731|||TWO_SIDED|95.0|-6.539|4.236||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-27 hours||4.236|-6.539|
73885872|NCT00674817|147305249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.249|STANDARD_ERROR_OF_MEAN|1.6816|||TWO_SIDED|95.0|-2.069|4.566||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||4.566|-2.069|
73885873|NCT00674817|147305249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.418|STANDARD_ERROR_OF_MEAN|1.6565|||TWO_SIDED|95.0|-2.85|3.687||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||3.687|-2.850|
73885874|NCT00674817|147305249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|1.705|||TWO_SIDED|95.0|-4.013|2.714||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||2.714|-4.013|
74077849|NCT02125461|147709551|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.38|TWO_SIDED|95.0|0.74|1.12||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for cough. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.12|0.74|0.380
73885875|NCT00674817|147305249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.949|STANDARD_ERROR_OF_MEAN|1.7112|||TWO_SIDED|95.0|-5.325|1.427||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||1.427|-5.325|
73885876|NCT00674817|147305250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.198|STANDARD_ERROR_OF_MEAN|2.5039|||TWO_SIDED|95.0|5.258|15.139||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||15.139|5.258|
73885877|NCT00674817|147305250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.686|STANDARD_ERROR_OF_MEAN|2.4738|||TWO_SIDED|95.0|-2.195|7.567||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||7.567|-2.195|
73885878|NCT00674817|147305250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.854|STANDARD_ERROR_OF_MEAN|2.5196|||TWO_SIDED|95.0|2.883|12.825||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||12.825|2.883|
73885879|NCT00674817|147305250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.884|STANDARD_ERROR_OF_MEAN|2.5244|||TWO_SIDED|95.0|-5.864|4.097||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||4.097|-5.864|
73885880|NCT00674817|147305250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.227|STANDARD_ERROR_OF_MEAN|2.9782|||TWO_SIDED|95.0|5.352|17.103||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||17.103|5.352|
73885881|NCT00674817|147305250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|2.9434|||TWO_SIDED|95.0|-1.418|10.197||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||10.197|-1.418|
73885882|NCT00674817|147305250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.975|STANDARD_ERROR_OF_MEAN|2.9958|||TWO_SIDED|95.0|0.065|11.886||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||11.886|0.065|
73885883|NCT00674817|147305250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.083|STANDARD_ERROR_OF_MEAN|3.0023|||TWO_SIDED|95.0|-8.006|3.84||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||3.840|-8.006|
73885884|NCT00674817|147305251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|1.6941|||TWO_SIDED|95.0|1.857|8.542||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||8.542|1.857|
73885885|NCT00674817|147305251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|1.6727|||TWO_SIDED|95.0|-3.294|3.307||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||3.307|-3.294|
73885886|NCT00674817|147305251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.956|STANDARD_ERROR_OF_MEAN|1.7178|||TWO_SIDED|95.0|-0.433|6.345||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||6.345|-0.433|
73885887|NCT00674817|147305251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.683|STANDARD_ERROR_OF_MEAN|1.7199|||TWO_SIDED|95.0|-5.076|1.711||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.711|-5.076|
73885888|NCT00674817|147305252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.588|STANDARD_ERROR_OF_MEAN|1.3932|||TWO_SIDED|95.0|3.839|9.336||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||9.336|3.839|
73885889|NCT00674817|147305252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.255|STANDARD_ERROR_OF_MEAN|1.3725|||TWO_SIDED|95.0|-1.453|3.962||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||3.962|-1.453|
73885890|NCT00674817|147305252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.985|STANDARD_ERROR_OF_MEAN|1.396|||TWO_SIDED|95.0|4.231|9.738||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||9.738|4.231|
73885891|NCT00674817|147305252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.255|STANDARD_ERROR_OF_MEAN|1.4077|||TWO_SIDED|95.0|-0.522|5.031||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||5.031|-0.522|
73885892|NCT00674817|147305252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.121|STANDARD_ERROR_OF_MEAN|1.2464|||TWO_SIDED|95.0|1.662|6.58||||||GSK961081 400 mcg Plus SAL versus maximal GSK961081 400 mcg plus Placebo during 0-27 hours||6.580|1.662|
73885893|NCT00674817|147305252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|1.2278|||TWO_SIDED|95.0|-2.142|2.703||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||2.703|-2.142|
73885894|NCT00674817|147305252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.266|STANDARD_ERROR_OF_MEAN|1.249|||TWO_SIDED|95.0|1.802|6.729||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||6.729|1.802|
73885895|NCT00674817|147305252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.621|STANDARD_ERROR_OF_MEAN|1.2593|||TWO_SIDED|95.0|-0.863|4.106||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||4.106|-0.863|
73885896|NCT00674817|147305253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.094|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|2.456|5.732||||||GSK961081 400 mcg plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||5.732|2.456|
73885897|NCT00674817|147305253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.646|STANDARD_ERROR_OF_MEAN|0.8172|||TWO_SIDED|95.0|-0.967|2.258||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||2.258|-0.967|
73885898|NCT00674817|147305253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.98|STANDARD_ERROR_OF_MEAN|0.8395|||TWO_SIDED|95.0|2.324|5.636||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||5.636|2.324|
73885899|NCT00674817|147305253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.934|STANDARD_ERROR_OF_MEAN|0.846|||TWO_SIDED|95.0|-0.735|2.603||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||2.603|-0.735|
73885900|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.836|STANDARD_ERROR_OF_MEAN|1.8168|||TWO_SIDED|95.0|-5.42|1.748||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||1.748|-5.420|
73885901|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.599|STANDARD_ERROR_OF_MEAN|1.7809|||TWO_SIDED|95.0|-2.914|4.113||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||4.113|-2.914|
74077850|NCT02125461|147709551|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.048|TWO_SIDED|95.0|0.56|1.0||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for hemoptysis. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.00|0.56|0.048
74077851|NCT02125461|147709551|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.626|TWO_SIDED|95.0|0.75|1.19||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for chest pain. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.19|0.75|0.626
74077852|NCT04383587|147709554|SUPERIORITY||||||>|0.18|||||||Fisher Exact|||Participants were grouped by age (18-35 vs. 36-50 vs. 51-65 vs. \>65), Sex at birth (Female vs. Male). and Occupational Role (Technician vs Anesthesiologist vs Advanced Practice Provider vs. Attendant Aide vs. CRNA vs. OR nurse vs Perfusionist vs Surgeon).||||>0.18
74077853|NCT04994535|147709569|SUPERIORITY||Difference (%)|30.9|||<|0.0001|TWO_SIDED|95.0|24.5|37.4||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||37.4|24.5|<.0001
74077854|NCT04994535|147709570|SUPERIORITY||Difference (%)|38.9|||<|0.0001|TWO_SIDED|95.0|31.3|46.4||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||46.4|31.3|<0.0001
74077855|NCT04994535|147709571|SUPERIORITY||Difference (%)|36.9|||<|0.0001|TWO_SIDED|95.0|29.1|44.7||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.7|29.1|<0.0001
74077856|NCT04994535|147709574|SUPERIORITY||Difference (%)|50.2|||<|0.0001|TWO_SIDED|95.0|42.0|58.3||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||58.3|42.0|<.0001
74077857|NCT04994535|147709575|SUPERIORITY||Difference (%)|27.1|||<|0.0001|TWO_SIDED|95.0|18.1|36.1||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||36.1|18.1|<.0001
74077858|NCT04994535|147709576|SUPERIORITY||Difference (%)|35.8|||<|0.0001|TWO_SIDED|95.0|27.4|44.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.2|27.4|<.0001
74077859|NCT04994535|147709577|SUPERIORITY||Difference (SE)|-4.4|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-5.4|-3.4||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-3.4|-5.4|<.0001
74077860|NCT04994535|147709580|SUPERIORITY||Difference (%)|42.9|||<|0.0001|TWO_SIDED|95.0|34.8|51.0||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||51.0|34.8|<0.0001
74077861|NCT04994535|147709581|SUPERIORITY||Difference (%)|49.4|||<|0.0001|TWO_SIDED|95.0|40.8|58.1||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||58.1|40.8|<0.0001
74077862|NCT04994535|147709582|SUPERIORITY||Difference (%)|28.8|||<|0.0001|TWO_SIDED|95.0|19.4|38.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||38.2|19.4|<0.0001
74077863|NCT04994535|147709583|SUPERIORITY||Difference (%)|35.9|||<|0.0001|TWO_SIDED|95.0|27.2|44.6||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.6|27.2|<0.0001
74077864|NCT04994535|147709584|SUPERIORITY||Difference (SE)|-4.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-5.8|-3.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-3.7|-5.8|<0.0001
74077865|NCT04994535|147709585|SUPERIORITY||Difference (SE)|-4.9|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-6.0|-3.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 30||-3.7|-6.0|<0.0001
74077866|NCT04994535|147709585|SUPERIORITY||Difference (SE)|-4.7|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-5.9|-3.6||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 60||-3.6|-5.9|<0.0001
74077867|NCT04994535|147709585|SUPERIORITY||Difference (SE)|-3.9|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-4.9|-2.8||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 90||-2.8|-4.9|<0.0001
74077868|NCT00567320|147709586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|TWO_SIDED|95.0|||||Mixed Models Analysis|||HLM analysis of % of Cocaine Positive Urines per week over 12 weeks. Subjects were used as a Random variable, with medication dosing set to 'Fixed'.||||0.84
74077869|NCT02294786|147709612|SUPERIORITY||Difference in Percentages|-4.8||||0.775|TWO_SIDED|95.0|-29.2|20.0|||Chi-squared|||Cycle 1-3 (up to 9 weeks)||20.0|-29.2|0.775
74077870|NCT01667679|147709649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|0.824|<|0.0001|TWO_SIDED|95.0|1.76|5.01|||ANCOVA|||||5.01|1.76|<0.0001
74077871|NCT01667679|147709650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.105||0.0013|TWO_SIDED|95.0|1.47|5.85|||ANCOVA||mild attacks|||5.85|1.47|0.0013
73885902|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.324|STANDARD_ERROR_OF_MEAN|1.8174|||TWO_SIDED|95.0|-3.261|3.909||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||3.909|-3.261|
74077872|NCT01667679|147709650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.76|STANDARD_ERROR_OF_MEAN|0.971||0.0002|TWO_SIDED|95.0|1.84|5.68|||ANCOVA||moderate/severe attacks|||5.68|1.84|0.0002
74077873|NCT01667679|147709651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.3549|TWO_SIDED|95.0|0.85|1.6|||ANCOVA||10 minutes post-dose|||1.60|0.85|0.3549
74077874|NCT01667679|147709651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0005|TWO_SIDED|95.0|1.2|1.9|||ANCOVA||15 minutes post-dose|||1.90|1.20|0.0005
74077875|NCT01667679|147709651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.45|2.21|||ANCOVA||30 minutes post-dose|||2.21|1.45|<0.0001
74077876|NCT01667679|147709651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.0002|TWO_SIDED|95.0|1.24|1.96|||ANCOVA||45 minutes post-dose|||1.96|1.24|0.0002
74077877|NCT01667679|147709651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.0057|TWO_SIDED|95.0|1.1|1.71|||ANCOVA||60 minutes post-dose|||1.71|1.10|0.0057
74077878|NCT01667679|147709651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.0654|TWO_SIDED|95.0|0.99|1.61|||ANCOVA||90 minutes post-dose|||1.61|0.99|0.0654
74077879|NCT01667679|147709651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.2894|TWO_SIDED|95.0|0.89|1.49|||ANCOVA||120 minutes post-dose|||1.49|0.89|0.2894
74077880|NCT01667679|147709652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.1771|TWO_SIDED|95.0|0.76|4.54|||ANCOVA||10 minutes post-dose|||4.54|0.76|0.1771
74077881|NCT01667679|147709652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.0077|TWO_SIDED|95.0|1.21|3.42|||ANCOVA||15 minutes post-dose|||3.42|1.21|0.0077
74077882|NCT01667679|147709652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.0003|TWO_SIDED|95.0|1.32|2.5|||ANCOVA||30 minutes post-dose|||2.50|1.32|0.0003
74077883|NCT01667679|147709652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||<|0.0001|TWO_SIDED|95.0|1.29|2.09|||ANCOVA||45 minutes post-dose|||2.09|1.29|<0.0001
74077884|NCT01667679|147709652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0016|TWO_SIDED|95.0|1.14|1.74|||ANCOVA||60 minutes post-dose|||1.74|1.14|0.0016
74077885|NCT01667679|147709652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0059|TWO_SIDED|95.0|1.09|1.69|||ANCOVA||90 minutes post-dose|||1.69|1.09|0.0059
74077886|NCT01667679|147709652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.2717|TWO_SIDED|95.0|0.91|1.42|||ANCOVA||120 minutes post-dose|||1.42|0.91|0.2717
74077887|NCT01667679|147709653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.2426|TWO_SIDED|95.0|0.87|1.77|||ANCOVA||10 minutes post-dose|||1.77|0.87|0.2426
74077888|NCT01667679|147709653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0069|TWO_SIDED|95.0|1.12|1.99|||ANCOVA||15 minutes post-dose|||1.99|1.12|0.0069
74077889|NCT01667679|147709653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94|||<|0.0001|TWO_SIDED|95.0|1.47|2.56|||ANCOVA||30 minutes post-dose|||2.56|1.47|<0.0001
74077890|NCT01667679|147709653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0004|TWO_SIDED|95.0|1.26|2.23|||ANCOVA||45 minutes post-dose|||2.23|1.26|0.0004
74077891|NCT01667679|147709653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.0008|TWO_SIDED|95.0|1.22|2.11|||ANCOVA||60 minutes post-dose|||2.11|1.22|0.0008
74077892|NCT01667679|147709653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0272|TWO_SIDED|95.0|1.04|1.83|||ANCOVA||90 minutes post-dose|||1.83|1.04|0.0272
74077893|NCT01667679|147709653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.2085|TWO_SIDED|95.0|0.9|1.62|||ANCOVA||120 minutes post-dose|||1.62|0.90|0.2085
74077894|NCT01667679|147709655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.021||0.3562|TWO_SIDED|95.0|-0.06|0.02|||ANCOVA||10 minutes post-dose|||0.02|-0.06|0.3562
74077895|NCT01667679|147709655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.029||0.0063|TWO_SIDED|94.0|-0.14|-0.02|||ANCOVA||15 minutes post-dose|||-0.02|-0.14|0.0063
74077896|NCT01667679|147709655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.26|-0.11|||ANCOVA||30 minutes post-dose|||-0.11|-0.26|< 0.0001
74077897|NCT01667679|147709655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.046||0.0005|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA||45 minutes post-dose|||-0.07|-0.26|0.0005
74077898|NCT01667679|147709655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.048||0.004|TWO_SIDED|95.0|-0.24|-0.05|||ANCOVA||60 minutes post-dose|||-0.05|-0.24|0.0040
74077899|NCT01667679|147709655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.0333|TWO_SIDED|95.0|-0.21|-0.01|||ANCOVA||90 minutes post-dose|||-0.01|-0.21|0.0333
74077900|NCT01667679|147709655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.052||0.4031|TWO_SIDED|95.0|-0.15|0.06|||ANCOVA||120 minutes post-dose|||0.06|-0.15|0.4031
74077901|NCT01667679|147709656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.019||0.0181|TWO_SIDED|95.0|-0.08|-0.01|||ANCOVA||10 minutes post-dose|||-0.01|-0.08|0.0181
74077902|NCT01667679|147709656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|-0.14|-0.04|||ANCOVA||15 minutes post-dose|||-0.04|-0.14|0.0003
74077903|NCT01667679|147709656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.23|-0.09|||ANCOVA||30 minutes post-dose|||-0.09|-0.23|< 0.0001
74077904|NCT01667679|147709656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.043||0.0001|TWO_SIDED|95.0|-0.25|-0.08|||ANCOVA||45 minutes post-dose|||-0.08|-0.25|0.0001
74077905|NCT01667679|147709656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.047||0.0006|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA||60 minutes post-dose|||-0.07|-0.26|0.0006
74077906|NCT01667679|147709656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.048||0.0189|TWO_SIDED|95.0|-0.21|-0.02|||ANCOVA||90 minutes post-dose|||-0.02|-0.21|0.0189
74077907|NCT01667679|147709656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.1704|TWO_SIDED|95.0|-0.17|0.03|||ANCOVA||120 minutes post-dose|||0.03|-0.17|0.1704
74077908|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.728||||0.0008|TWO_SIDED|95.0|-4.219|-1.236|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean||-1.236|-4.219|0.0008
74077909|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.325||||0.0021|TWO_SIDED|95.0|-3.735|-0.916|||ANCOVA|||Difference from placebo toGSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean||-0.916|-3.735|0.0021
74077910|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.402||||0.0021|TWO_SIDED|95.0|-3.862|-0.942|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean||-0.942|-3.862|0.0021
74077911|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.556||||0.0382|TWO_SIDED|95.0|0.09|3.021|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean||3.021|0.090|0.0382
74077912|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.958||||0.0132|TWO_SIDED|95.0|0.439|3.477|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean||3.477|0.439|0.0132
74077913|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.881||||0.0161|TWO_SIDED|95.0|0.373|3.389|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean||3.389|0.373|0.0161
74077914|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.592||||0.0001|TWO_SIDED|95.0|-5.162|-2.022|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean||-2.022|-5.162|0.0001
74077915|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82||||0|TWO_SIDED|95.0|-5.304|-2.337|||ANCOVA|||Difference from placebo to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean||-2.337|-5.304|0.0000
74077916|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.887||||0.0006|TWO_SIDED|95.0|-4.424|-1.35|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean||-1.350|-4.424|0.0006
74077917|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.953||||0.0005|TWO_SIDED|95.0|1.411|4.496|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean||4.496|1.411|0.0005
74077918|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.725||||0.0015|TWO_SIDED|95.0|1.126|4.324|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean||4.324|1.126|0.0015
74077919|NCT00575159|147709697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.659||||0.0001|TWO_SIDED|95.0|2.071|5.246|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean||5.246|2.071|0.0001
74077920|NCT03733444|147709709|SUPERIORITY||Least Squares (LS) Mean difference|2.8|STANDARD_ERROR_OF_MEAN|25.29||0.9123|TWO_SIDED|95.0|-46.9|52.4||P-value was based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||52.4|-46.9|0.9123
74077921|NCT03733444|147709709|SUPERIORITY||LS Mean difference|1.7|STANDARD_ERROR_OF_MEAN|25.01||0.9456|TWO_SIDED|95.0|-47.4|50.8||P-value was based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||50.8|-47.4|0.9456
73885903|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.182|STANDARD_ERROR_OF_MEAN|1.8242|||TWO_SIDED|95.0|-5.781|1.416||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.416|-5.781|
73885904|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.266|STANDARD_ERROR_OF_MEAN|1.7723|||TWO_SIDED|95.0|-6.762|0.23||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.230|-6.762|
73885905|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|1.7361|||TWO_SIDED|95.0|-3.502|3.348||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||3.348|-3.502|
73885906|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.827|STANDARD_ERROR_OF_MEAN|1.7743|||TWO_SIDED|95.0|-1.673|5.327||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||5.327|-1.673|
74077922|NCT03733444|147709710|SUPERIORITY||Odds Ratio (OR)|1.15||||0.5162|TWO_SIDED|95.0|0.76|1.74|||Regression, Logistic|||||1.74|0.76|0.5162
74077923|NCT03733444|147709710|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7566|TWO_SIDED|95.0|0.71|1.62|||Regression, Logistic|||||1.62|0.71|0.7566
73885907|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.232|STANDARD_ERROR_OF_MEAN|1.78|||TWO_SIDED|95.0|-4.743|2.279||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.279|-4.743|
73885908|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.394|STANDARD_ERROR_OF_MEAN|1.3084|||TWO_SIDED|95.0|-3.976|1.187||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||1.187|-3.976|
73885909|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.181|STANDARD_ERROR_OF_MEAN|1.2819|||TWO_SIDED|95.0|-1.348|3.71||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||3.710|-1.348|
73885910|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|1.3201|||TWO_SIDED|95.0|-2.498|2.71||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||2.710|-2.498|
73885911|NCT00674817|147305254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.713|STANDARD_ERROR_OF_MEAN|1.3241|||TWO_SIDED|95.0|-3.325|1.899||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||1.899|-3.325|
74077924|NCT03733444|147709711|SUPERIORITY||Hazard Ratio (HR)|2.15|||||TWO_SIDED|95.0|1.2|3.85|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first respiratory-related hospitalization.|||3.85|1.20|
74077925|NCT03733444|147709711|SUPERIORITY||Hazard Ratio (HR)|1.69|||||TWO_SIDED|95.0|0.93|3.1|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first respiratory-related hospitalization.|||3.10|0.93|
74077926|NCT03733444|147709712|SUPERIORITY||LS Mean difference|-0.1||||0.937|TWO_SIDED|95.0|-3.2|3.0||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|Mixed Models Analysis|||||3.0|-3.2|0.9370
74077927|NCT03733444|147709712|SUPERIORITY||LS Mean difference|-0.4||||0.8064|TWO_SIDED|95.0|-3.4|2.7||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|Mixed Models Analysis|||||2.7|-3.4|0.8064
74077928|NCT03733444|147709713|SUPERIORITY||LS Mean difference|2.9|STANDARD_ERROR_OF_MEAN|23.39|||TWO_SIDED|95.0|-41.1|46.8|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||46.8|-41.1|
74077929|NCT03733444|147709713|SUPERIORITY||LS Mean difference|8.0|STANDARD_ERROR_OF_MEAN|22.16|||TWO_SIDED|95.0|-35.5|51.5|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||51.5|-35.5|
74077930|NCT03733444|147709714|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.9|1.94|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.94|0.90|
73885912|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.561|STANDARD_ERROR_OF_MEAN|1.2351|||TWO_SIDED|95.0|-2.997|1.876||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||1.876|-2.997|
74077931|NCT03733444|147709714|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.72|1.56|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.56|0.72|
74077932|NCT03733444|147709715|SUPERIORITY||LS Mean difference|0.9|||||TWO_SIDED|95.0|-12.4|14.1|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||14.1|-12.4|
74077933|NCT03733444|147709715|SUPERIORITY||LS Mean difference|3.6|||||TWO_SIDED|95.0|-10.4|17.6|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||17.6|-10.4|
74077934|NCT03733444|147709716|SUPERIORITY||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|1.01|2.35|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||2.35|1.01|
73885913|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.705|STANDARD_ERROR_OF_MEAN|1.2125|||TWO_SIDED|95.0|-0.687|4.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||4.097|-0.687|
73885914|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.337|STANDARD_ERROR_OF_MEAN|1.2341|||TWO_SIDED|95.0|-3.771|1.098||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.098|-3.771|
73885915|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.067|STANDARD_ERROR_OF_MEAN|1.2416|||TWO_SIDED|95.0|-3.516|1.382||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.382|-3.516|
73885916|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.376|STANDARD_ERROR_OF_MEAN|1.0997|||TWO_SIDED|95.0|-2.545|1.794||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||1.794|-2.545|
74077935|NCT03733444|147709716|SUPERIORITY||Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.91|2.16|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all cause hospitalization.|||2.16|0.91|
74077936|NCT03733444|147709719|SUPERIORITY||Hazard Ratio (HR)|2.92|||||TWO_SIDED|95.0|1.04|8.14|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||8.14|1.04|
73885917|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.0786|||TWO_SIDED|95.0|-1.588|2.668||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||2.668|-1.588|
73885918|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|1.0999|||TWO_SIDED|95.0|-2.185|2.154||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.154|-2.185|
74077937|NCT03733444|147709719|SUPERIORITY||Hazard Ratio (HR)|1.68|||||TWO_SIDED|95.0|0.55|5.13|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||5.13|0.55|
73885919|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|1.1058|||TWO_SIDED|95.0|-1.715|2.648||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.648|-1.715|
73885920|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|0.881|||TWO_SIDED|95.0|-2.918|0.559||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.559|-2.918|
73885921|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.876|STANDARD_ERROR_OF_MEAN|0.8644|||TWO_SIDED|95.0|-0.829|2.582||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||2.582|-0.829|
73885922|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.809|STANDARD_ERROR_OF_MEAN|0.8882|||TWO_SIDED|95.0|-2.561|0.944||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.944|-2.561|
73885923|NCT00674817|147305255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.8929|||TWO_SIDED|95.0|-2.122|1.401||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||1.401|-2.122|
73885924|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.2352|||TWO_SIDED|95.0|0.066|0.994||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.994|0.066|
73885925|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.388|STANDARD_ERROR_OF_MEAN|0.2318|||TWO_SIDED|95.0|-0.069|0.846||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.846|-0.069|
73885926|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.2363|||TWO_SIDED|95.0|-0.157|0.775||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.775|-0.157|
73885927|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.2392|||TWO_SIDED|95.0|-0.163|0.78||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.780|-0.163|
73885928|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.874|STANDARD_ERROR_OF_MEAN|0.3099|||TWO_SIDED|95.0|0.262|1.485||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||1.485|0.262|
73885929|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.3056|||TWO_SIDED|95.0|-0.656|0.55||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.550|-0.656|
73885930|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.829|STANDARD_ERROR_OF_MEAN|0.3112|||TWO_SIDED|95.0|0.215|1.443||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||1.443|0.215|
73885931|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.567|STANDARD_ERROR_OF_MEAN|0.3151|||TWO_SIDED|95.0|-0.054|1.189||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||1.189|-0.054|
73885932|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.312|STANDARD_ERROR_OF_MEAN|0.1021|||TWO_SIDED|95.0|0.11|0.513||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.513|0.110|
73885933|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.1006|||TWO_SIDED|95.0|-0.025|0.372||||||GSK961081 400 mcg Plus IPR versus maximum GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.372|-0.025|
74077938|NCT03733444|147709720|SUPERIORITY||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.06|4.82|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.82|1.06|
74077939|NCT03733444|147709720|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|95.0|0.86|4.06|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.06|0.86|
74077940|NCT03733444|147709721|SUPERIORITY||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.06|4.82|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.82|1.06|
74077941|NCT03733444|147709721|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|95.0|0.86|4.06|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.06|0.86|
74077942|NCT03733444|147709722|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|1.2|3.31|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||3.31|1.20|
74077943|NCT03733444|147709722|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.88|2.54|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||2.54|0.88|
74077944|NCT03733444|147709723|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|1.2|3.31|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or respiratory-related hospitalizations.|||3.31|1.20|
73885934|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.1035|||TWO_SIDED|95.0|0.006|0.414||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.414|0.006|
73885935|NCT00674817|147305256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.1047|||TWO_SIDED|95.0|-0.103|0.311||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.311|-0.103|
73885936|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.0503|||TWO_SIDED|95.0|-0.276|-0.078||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||-0.078|-0.276|
73885937|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED|95.0|-0.096|0.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.097|-0.096|
74077945|NCT03733444|147709723|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.88|2.54|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or respiratory-related hospitalizations.|||2.54|0.88|
74077946|NCT00556322|147709745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.7299|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||||1.19|0.78|0.7299
74077947|NCT00556322|147709748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.6198|TWO_SIDED|95.0|0.72|1.21|||Log Rank|||Comparison of EGFR positive populations||1.21|0.72|0.6198
74077948|NCT00556322|147709748|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.95||||0.8398|TWO_SIDED|95.0|0.55|1.62|||Log Rank|||Comparison of EGFR negative populations||1.62|0.55|0.8398
73885938|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.0498|||TWO_SIDED|95.0|-0.174|0.022||||||SK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.022|-0.174|
73885939|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.0507|||TWO_SIDED|95.0|-0.128|0.072||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.072|-0.128|
73885940|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.166|STANDARD_ERROR_OF_MEAN|0.0493|||TWO_SIDED|95.0|-0.263|-0.069||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||-0.069|-0.263|
73885941|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.0481|||TWO_SIDED|95.0|-0.152|0.038||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.038|-0.152|
73885942|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.171|STANDARD_ERROR_OF_MEAN|0.0489|||TWO_SIDED|95.0|-0.267|-0.075||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||-0.075|-0.267|
73885943|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.0498|||TWO_SIDED|95.0|-0.108|0.089||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||0.089|-0.108|
73885944|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.0522|||TWO_SIDED|95.0|-0.211|-0.005||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||-0.005|-0.211|
73885945|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.0509|||TWO_SIDED|95.0|-0.087|0.114||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.114|-0.087|
73885946|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.18|0.026||||||GSK961081 1200 mcg Plus SAL GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.026|-0.180|
73885947|NCT00674817|147305257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.0529|||TWO_SIDED|95.0|-0.129|0.08||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.080|-0.129|
73885948|NCT00837434|147305269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|TWO_SIDED||||||ANCOVA|P-value for testing treatment effect uses week 12 CD27+ switched memory as the outcome variable and adjusts for baseline CD27+ switched memory||Null Hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 does not differ between individuals treated with etanercept and those treated with adalimumab after adjusting for baseline CD27+ switched memory cells. Alt. hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 in individuals treated with etanercept is lower than in those treated with adalimumab after adjusting for baseline CD27+ switched memory cells.||||0.3
73885949|NCT00459316|147305279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||||||Two-sided p-value \<0.05 was specified as statistically significant a priori. There were no adjustments for multiple outcomes.|Fisher Exact|||The null hypothesis was that there would be no difference between CD4% strata.||||0.03
74077949|NCT00556322|147709751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.0885|TWO_SIDED|95.0|0.97|1.46|||Log Rank|||||1.46|0.97|0.0885
74077950|NCT00556322|147709754|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.0662|TWO_SIDED|95.0|0.98|1.61|||Log Rank|||Comparison of EGFR positive populations||1.61|0.98|0.0662
74077951|NCT00556322|147709754|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9403|TWO_SIDED|95.0|0.61|1.69|||Log Rank|||Comparison of EGFR negative populations||1.69|0.61|0.9403
73885950|NCT00459316|147305280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||||||Two sided-p-value \<0.05 was specified as statistically significant a priori. No adjustment for multiple primary outcomes was made.|Fisher Exact|||The null hypothesis was that there were no differences between CD4% strata.||||0.01
73885951|NCT03697252|147305322|SUPERIORITY||LS mean difference|-11.56|||<|0.0001|TWO_SIDED|95.0|-16.07|-7.05|||Mixed model for repeated measures||||Statistics are from a mixed model for repeated measures (MMRM). The model includes the treatment group (KarXT or placebo), visit, and the interaction between the treatment group and visit as fixed factors, and baseline PANSS total score, site, age, and gender as covariates. An unstructured covariance matrix is used to model the correlation among repeated measurements and the denominator degrees of freedom are computed using the Kenward-Roger method.|-7.05|-16.07|<0.0001
73885952|NCT03697252|147305324|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of KarXT and Placebo at Week 5||||<0.001
73885953|NCT05712460|147305441|OTHER||Ratio|126.65|||||TWO_SIDED|90.0|106.87|150.1|||||Analysis was performed using mixed effect model with sequence, and treatment as fixed effects and participant within sequence as a random effect.|||150.10|106.87|
73885954|NCT05712460|147305442|OTHER||Ratio|142.94|||||TWO_SIDED|90.0|117.2|174.32|||||Analysis was performed using mixed effect model with sequence, and treatment as fixed effects and participant within sequence as a random effect.|||174.32|117.20|
73885955|NCT02735863|147305458|SUPERIORITY|||||||0.5352|||||||Log Rank|||||||0.5352
73885956|NCT00829426|147305459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% Confidence Interval falls withi 80-125.|Geometric Test/Ref Ratio x 100|102.56|||||TWO_SIDED|90.0|98.74|106.52|||||Bioequivalence is established when 90% Confidence Interval falls withi 80-125.|||106.52|98.74|
73885957|NCT00829426|147305460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|92.88||||||90.0|90.34|95.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||95.48|90.34|
73885958|NCT00829426|147305461|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|93.92||||||90.0|91.47|96.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||96.44|91.47|
73885959|NCT05560425|147305463|EQUIVALENCE|"The equivalence margin is a range of the compliance score for which the independent training of skills in each group is close enough to be considered equivalent."|Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|3.45|<|0.05|TWO_SIDED|95.0|-6.22|8.79|||t-test, 1 sided|degrees of freedom = 12||Null hypothesis: Compliance with independent training of skills is not equivalent between groups.||8.79|-6.22|<0.05
74077952|NCT00556322|147709756|SUPERIORITY_OR_OTHER||Difference in Response Rates|1.55||||0.5349|TWO_SIDED|95.0|-3.6|6.7||p-values are based on non-stratified analysis|Chi-squared||Approximate 95% CI for the difference of two rates was determined using Hauck-Anderson Method|||6.7|-3.6|0.5349
73885960|NCT00311766|147305475|SUPERIORITY_OR_OTHER||ANCOVA|0.8|||>|0.05|TWO_SIDED|95.0|||||Fisher Exact|||The primary population was the Full Analysis(FA)population. The FA population included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded||||>0.05
73885961|NCT02260934|147305477|SUPERIORITY|||||||0.58||||||Two-sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 24||||0.58
73885962|NCT02260934|147305477|SUPERIORITY|||||||0.25||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 48||||0.25
73885963|NCT02260934|147305477|SUPERIORITY|||||||0.15||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 96.||||0.15
73885964|NCT02260934|147305479|SUPERIORITY|P-value could not be produced because of zero count in at least one of the treatment arms.|||||||||||||Regression, Logistic|Two sided test. P-value could not be produced because of zero count in at least one of the treatment arms.||Week 0 to Week 24|Treatment group was the independent variable in the logistic regression.|||
73885965|NCT02260934|147305479|SUPERIORITY||||||||||||||Regression, Logistic|P-value could not be produced because of zero count in at least one of the treatment arms.||Week 0 to Week 48|P-value could not be produced because of zero count in at least one of the treatment arms.|||
73885966|NCT02260934|147305479|SUPERIORITY|P-value could not be produced because of zero count in at least one of the treatment arms|||||||||||||Regression, Logistic|P-value could not be produced because of zero count in at least one of the treatment arms||Week 0 to Week 96 The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.|P-value could not be produced because of zero count in at least one of the treatment arms|||
73885967|NCT02260934|147305480|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.66||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 24||||0.66
74077953|NCT00556322|147709758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.1498|TWO_SIDED|95.0|0.93|1.59|||Log Rank|||||1.59|0.93|0.1498
74077954|NCT00556322|147709761|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2202|TWO_SIDED|95.0|0.9|1.57|||Log Rank|||||1.57|0.90|0.2202
74077955|NCT00556322|147709764|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.1063|TWO_SIDED|95.0|0.95|1.66|||Log Rank|||||1.66|0.95|0.1063
73885968|NCT02260934|147305480|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.65||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 48|Treatment group was the independent variable in the logistic regression.|||0.65
73885969|NCT02260934|147305481|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.64||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 24 Treatment group was the independent variable in the logistic regression.||||0.64
74077956|NCT04813354|147709794|SUPERIORITY||Odds Ratio (OR)|0.11|||<|0.001|TWO_SIDED|95.0|0.01|0.4|||Exact conditional logistic regression||Odds ratio between ELLIPTA DPI and BREEZHALER DPI was calculated using an exact conditional logistic regression model with participant as fixed strata, inhaler and period as fixed effects.|||0.40|0.01|<0.001
74077957|NCT04813354|147709796|OTHER||Odds Ratio (OR)|0.25||||0.005|TWO_SIDED|95.0|0.03|0.74|||Exact conditional logistic regression||Odds ratio between ELLIPTA DPI and BREEZHALER DPI was calculated using an exact conditional logistic regression model with participant as fixed strata, inhaler and period as fixed effects.|||0.74|0.03|0.005
74077958|NCT04813354|147709805|OTHER||Mean Difference (Final Values)|27.63|||<|0.001|TWO_SIDED|95.0|21.31|33.96|||Paired samples t-test|||||33.96|21.31|<0.001
73885970|NCT02260934|147305481|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.37||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 48||||0.37
73885971|NCT02260934|147305481|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.32|||||||Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 96||||0.32
73885972|NCT02260934|147305482|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.91||||||2 sided test|Regression, Logistic|2 sided test||Week 96||||0.91
73885973|NCT02260934|147305483|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.73||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 24||||.73
73885974|NCT02260934|147305483|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.26||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 48||||0.26
73885975|NCT02260934|147305483|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.29||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 96||||0.29
73885976|NCT02260934|147305484|SUPERIORITY|2 sided test|||||>|0.99||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 24||||>0.99
73885977|NCT02260934|147305485|SUPERIORITY|2 sided test||||||0.49||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 48||||0.49
73885978|NCT02260934|147305487|SUPERIORITY|2 sided test||||||0.89||||||2 sided test|Regression, Logistic|||Treatment group was the independent variable in the logistic regression.||||0.89
73885979|NCT02260934|147305487|SUPERIORITY|Week 48||||||0.47||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.47
73885980|NCT02260934|147305487|SUPERIORITY|Week 96||||||0.94||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.94
73885981|NCT02260934|147305488|SUPERIORITY|Week 24||||||0.08||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.08
73885982|NCT02260934|147305488|SUPERIORITY|Week 48||||||0.11||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.11
73885983|NCT02260934|147305488|SUPERIORITY|Week 96||||||0.05||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.05
73885984|NCT02260934|147305489|SUPERIORITY|Week 24||||||0.2||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||.20
73885985|NCT02260934|147305489|SUPERIORITY|Week 48|||||>|0.99||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||>0.99
73885986|NCT02260934|147305489|SUPERIORITY|Week 96||||||0.63||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.63
73885987|NCT01436526|147305492|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.35||||0.0438||90.0|101.59|115.57|||ANOVA|||||115.57|101.59|0.0438
73885988|NCT01436526|147305493|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.19||||0.0514||90.0|101.31|115.54|||ANOVA|||||115.54|101.31|0.0514
74077959|NCT01940341|147709829|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample sizes of 130 and 260 participants in the TDF group and TAF groups, respectively were planned to give 90% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size was based on the assumption that the expected difference (TAF-TDF) in proportion of participants with HBV DNA\<29 IU/mL was 0 and the proportion of participants with HBV DNA\<29 IU/mL in the TDF group was 91%. All missing data were treated as not achieving the primary endpoint.|Difference in proportions|1.8|||||TWO_SIDED|95.0|-3.6|7.2|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.||7.2|-3.6|
74077960|NCT01237054|147709852|SUPERIORITY|||||||0.024||||||The reported p-value is representative of the difference in levels of Ang2 in both groups.|Wilcoxon rank sum test|||||||0.024
73885989|NCT01436526|147305494|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|111.64||||0.0685||90.0|101.14|123.23|||ANOVA|||||123.23|101.14|0.0685
73885990|NCT03605667|147305500|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.93||0.9809|TWO_SIDED|95.0|-1.8|1.8|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, mini-mental state examination (MMSE) randomization stratification, apolipoprotein E (APoE) status (carrier/non carrier), as covariates, and repeated measures for visit within participant.||1.8|-1.8|0.9809
73885991|NCT03605667|147305501|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4474|TWO_SIDED|95.0|-0.8|0.3|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APoE status (carrier/non carrier), as covariates, and repeated measures for visit within participant.||0.3|-0.8|0.4474
73885992|NCT03605667|147305502|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.867|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Model based summary statistics were from an analysis of covariance (ANCOVA) with baseline MMSE total score as covariate.||0.5|-0.6|0.8670
73885993|NCT03605667|147305503|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|1.6|STANDARD_ERROR_OF_MEAN|1.21||0.195|TWO_SIDED|95.0|-0.8|3.9|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||3.9|-0.8|0.1950
73885994|NCT03605667|147305504|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.31||0.2583|TWO_SIDED|95.0|-1.1|4.1|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||4.1|-1.1|0.2583
73888561|NCT01929317|147309699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 8.|||0.7|-0.7|
73885995|NCT03605667|147305505|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.48||0.4191|TWO_SIDED|95.0|-0.6|1.3|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||1.3|-0.6|0.4191
73885996|NCT03605667|147305507|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.224|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||Model based summary statistics are from an ANCOVA with baseline MMSE total score as covariate.||0.3|-1.2|0.2240
73885997|NCT03605667|147305508|SUPERIORITY|||||||0.0161|||||||Fisher Exact|||||||0.0161
73885998|NCT00107653|147305525|SUPERIORITY_OR_OTHER||SVR for Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08||P-values are calculated based on the difference in proportion between Latino and Non-Latino White group|Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with SVR. The 95% Confidence Interval is based on normal approximation to the binomial.|SVR for Latino Versus (VS) Non-Latino White||-0.08|-0.24|<0.0001
73885999|NCT00107653|147305526|SUPERIORITY_OR_OTHER||Study Group Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.031||0.0454|TWO_SIDED|95.0|-0.12|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4||-0.00|-0.12|0.0454
73886000|NCT00107653|147305526|SUPERIORITY_OR_OTHER||Study Group Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003|TWO_SIDED|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12||-0.07|-0.23|0.0003
73886001|NCT00107653|147305526|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.039||0.0004|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 24||-0.06|-0.22|0.0004
73886002|NCT00107653|147305526|SUPERIORITY_OR_OTHER||Study Group Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 48||-0.09|-0.24|<0.0001
73886003|NCT00107653|147305526|SUPERIORITY_OR_OTHER||Study Group Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.25|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 60||-0.09|-0.25|<0.0001
73886004|NCT00107653|147305526|SUPERIORITY_OR_OTHER||Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 72||-0.08|-0.24|<0.0001
73886005|NCT00107653|147305527|SUPERIORITY_OR_OTHER||Study Group Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.036||0.0353|TWO_SIDED|95.0|-0.15|-0.01|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4||-0.01|-0.15|0.0353
73886006|NCT00107653|147305528|SUPERIORITY_OR_OTHER||Study Group Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.033||0.0014|TWO_SIDED|95.0|-0.17|-0.04|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12||-0.04|-0.17|0.0014
73886007|NCT00107653|147305530|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.042||0.0006|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 4||-0.06|-0.22|0.0006
74077961|NCT01237054|147709852|SUPERIORITY|||||||0.055||||||The reported p-value is representative of the difference in levels of G-CSF in both groups.|Wilcoxon rank sum test|||||||0.055
73886008|NCT00107653|147305530|SUPERIORITY_OR_OTHER||Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 12||-0.08|-0.24|<0.0001
73886009|NCT00107653|147305530|SUPERIORITY_OR_OTHER||Study Group Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003|TWO_SIDED|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 24||-0.07|-0.23|0.0003
73886010|NCT00107653|147305530|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.042||0.0008|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 48||-0.06|-0.22|0.0008
74077962|NCT01237054|147709852|SUPERIORITY|||||||0.055||||||The reported p-value is representative of the difference in levels of Follistatin in both groups.|Wilcoxon rank sum test|||||||0.055
73886011|NCT00107653|147305530|SUPERIORITY_OR_OTHER||Study Group Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.26|-0.1|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 60||-0.10|-0.26|<0.0001
73886012|NCT00107653|147305530|SUPERIORITY_OR_OTHER||Study Group Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.27|-0.11|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 72||-0.11|-0.27|<0.0001
73886013|NCT00107653|147305531|SUPERIORITY_OR_OTHER||Study Group Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0285|TWO_SIDED|95.0|-0.2|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with ISHAK HAI response. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI Response For Latino VS Non-Latino White||-0.0|-0.2|0.0285
73886014|NCT00107653|147305532|SUPERIORITY_OR_OTHER||Study Group Difference|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.5|1.3|||Normal approximation to the binomial.||The estimated value is the difference in change from baseline of ISHAK HAI activity (necroinflammatory) scores between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI activity For Latino VS Non-Latino White||1.3|0.5|<0.0001
73886015|NCT00107653|147305541|SUPERIORITY_OR_OTHER||Study Group Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.162|<|0.0001|TWO_SIDED|95.0|-0.96|-0.33|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 48||-0.33|-0.96|<0.0001
73886016|NCT00107653|147305541|SUPERIORITY_OR_OTHER||Study Group Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.156||0.0921|TWO_SIDED|95.0|-0.57|0.04|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 72||0.04|-0.57|0.0921
73886017|NCT00107653|147305541|SUPERIORITY_OR_OTHER||Study Group Difference|-8.72|STANDARD_ERROR_OF_MEAN|2.725||0.0015|TWO_SIDED|95.0|-14.07|-3.36|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 48 between Latino and Non-Latino White participants The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 48||-3.36|-14.07|0.0015
74077963|NCT01237054|147709852|SUPERIORITY|||||||0.0098||||||The reported p-value is representative of the difference in levels of HGF in both groups.|Wilcoxon rank sum test|||||||0.0098
73886018|NCT00107653|147305541|SUPERIORITY_OR_OTHER||Study Group Difference|4.83|STANDARD_ERROR_OF_MEAN|2.37||0.0421|TWO_SIDED|95.0|0.18|9.49|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 72||9.49|0.18|0.0421
73886019|NCT00107653|147305542|SUPERIORITY_OR_OTHER||Study Group Difference|3.49|STANDARD_ERROR_OF_MEAN|0.864|<|0.0001|TWO_SIDED|95.0|1.79|5.18|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 48||5.18|1.79|<0.0001
73886020|NCT00107653|147305542|SUPERIORITY_OR_OTHER||Study Group Difference|0.1|STANDARD_ERROR_OF_MEAN|0.808||0.9047|TWO_SIDED|95.0|-1.49|1.68|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 72||1.68|-1.49|0.9047
74077964|NCT01237054|147709852|SUPERIORITY|||||||0.02||||||The reported p-value is representative of the difference in levels of VEGF-A in both groups.|Wilcoxon rank sum test|||||||0.02
74077965|NCT01237054|147709853|OTHER|Other, trend test.||||||0.008|||||||Jonckheere-Terpstra test for trend|||||||0.008
74077966|NCT01237054|147709854|OTHER|Other, trend test.||||||0.15||||||The reported p-value is representative of the difference in levels of Kep between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend|||||||0.15
73886021|NCT00107653|147305542|SUPERIORITY_OR_OTHER||Study Group Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.914||0.9286|TWO_SIDED|95.0|-1.88|1.71|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 48||1.71|-1.88|0.9286
73886022|NCT00107653|147305542|SUPERIORITY_OR_OTHER||Study Group Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.888||0.1653|TWO_SIDED|95.0|-2.98|0.51|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 72||0.51|-2.98|0.1653
73888562|NCT01929317|147309699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 12.|||0.5|-0.9|
74077967|NCT01237054|147709854|OTHER|Other, trend test.||||||0.33||||||The reported p-value is representative of the difference in levels of Ktrans between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend|||||||0.33
74077968|NCT01237054|147709855|SUPERIORITY|||||||0.08|||||||Wilcoxon rank sum test|||||||0.08
73886023|NCT05720897|147305653|SUPERIORITY|||||||0.399||||||The calculations are based on a Mann Whitney calculation.|Wilcoxon (Mann-Whitney)|||The study has an 80% power to detect changes in patient's self-reported anxiety as measured by their responses to the psychometrically validated STAI-S \& T instrument of 3.6 within each group (with an effect size of 0.55) and differences of a 5.0 between groups (with an effect size of 0.77).||||.399
73886024|NCT00400179|147305659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3952||95.0|||||Fisher Exact|||||||0.3952
73886025|NCT00400179|147305660|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0808|TWO_SIDED|95.0|0.57|1.03|||Log Rank|||||1.03|0.57|0.0808
73886026|NCT00400179|147305661|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.9158|TWO_SIDED|95.0|0.86|1.14|||Log Rank|||||1.14|0.86|0.9158
73886027|NCT00400179|147305662|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.032|TWO_SIDED|95.0|0.77|0.99|||Log Rank|||||0.99|0.77|0.0320
73886028|NCT00400179|147305663|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.1983|TWO_SIDED|95.0|0.8|1.05|||Log Rank|||||1.05|0.80|0.1983
73886029|NCT04780061|147305664|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||An area under the curve approach was used to analyze the primary outcome, whereby participants' scores for each assessment were summed over the 21-day period. For missing values, we imputed the mean of the most recent and first subsequent measurement or carried the last observation forward if there was no subsequent measurement.||||0.53
73886030|NCT04780061|147305666|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
73886031|NCT04780061|147305667|SUPERIORITY|||||||0.81|||||||Log Rank|||||||0.81
74077969|NCT01237054|147709856|SUPERIORITY|||||||0.011|||||||Wilcoxon rank sum test|||||||0.011
74077970|NCT00520234|147709860|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Cochran-Mantel-Haenszel|APACHE II Stratified||||||0.14
74077971|NCT03527485|147709896|EQUIVALENCE|Between-group comparisons of binding potential non displaceable (BPND) in ventral striatum (VS).||||||0.011|||||||ANOVA|||||||0.011
73886032|NCT05523089|147305670|SUPERIORITY||Hodges-Lehmann estimator|-1.2||||0.039|TWO_SIDED|95.0|-5.7|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.0|-5.7|0.0390
73886033|NCT05523089|147305672|SUPERIORITY||Mean Difference (Net)|-1.4||||0.0185|TWO_SIDED|95.0|-2.9|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||-0.0|-2.9|0.0185
74077972|NCT03527485|147709896|EQUIVALENCE|Between-group comparisons of binding potential non displaceable (BPND) in Prefrontal cortex (PFC).||||||0.044|||||||ANOVA|||||||0.044
74077973|NCT00730691|147709897|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.843||0.255|TWO_SIDED|95.0|-2.62|0.69||This treatment arm is not in the pre-specified testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05) comparing each of the 3 doses of vortioxetine to placebo.||0.69|-2.62|0.255
73886034|NCT05523089|147305674|SUPERIORITY|||||||0.0613||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.0613
73886035|NCT05523089|147305675|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.1587|TWO_SIDED|95.0|-2.4|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.0|-2.4|0.1587
73886036|NCT05523089|147305677|SUPERIORITY||Mean Difference (Net)|-1.1||||0.0236|TWO_SIDED|95.0|-2.0|-0.1||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||-0.1|-2.0|0.0236
73886037|NCT05523089|147305679|SUPERIORITY|||||||0.1282||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.1282
73886038|NCT05523089|147305680|SUPERIORITY||Mean Difference (Net)|-5.4||||0.2877|TWO_SIDED|95.0|-11.2|0.3||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.3|-11.2|0.2877
73886039|NCT05523089|147305682|SUPERIORITY||Mean Difference (Net)|-1.8||||0.2517|TWO_SIDED|95.0|-4.1|0.6||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.6|-4.1|0.2517
73886040|NCT05523089|147305686|SUPERIORITY|||||||0.9024||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.9024
73886041|NCT05523089|147305687|SUPERIORITY|||||||0.0248||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.0248
73886042|NCT05523089|147305689|SUPERIORITY|||||||0.1224||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1224
73886043|NCT05523089|147305691|SUPERIORITY|||||||0.1023||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1023
73886044|NCT05523089|147305693|SUPERIORITY|||||||0.1477||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1477
73886045|NCT05523089|147305695|SUPERIORITY|||||||0.1645||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1645
73886046|NCT02677493|147305707|EQUIVALENCE|"All statistical significance testing was performed at a two-sided significance level (α) of 5%.~Exceptionally, non-inferiority was tested at a one-sided CI of 97.5%."||||||0.09135|||||||ANCOVA|||To evaluate if the seroconversion (SCR) and seroprotection (SPR) rates on Day 28 after vaccination of IL-YANG Quadrivalent Influenza Vaccine Inj. meet the following criteria in all age groups of healthy male and female adults at the age of 19 or older.||||0.09135
73886047|NCT01456039|147305716|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis ( H0 p≤0.1)|Binomial test for dichotomized response|||||||<0.0001
73886048|NCT00335777|147305739|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|2 sided McNemar test||||||0.289|TWO_SIDED|95.0|||||McNemar|2 sided McNemar||Null hypothesis: there is no difference in the proportion of subjects who were pain free when treating early, as compared to treating late.||||0.289
73886049|NCT00335777|147305740|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|2 sided McNemar test||||||1|||||||McNemar|2 sided McNemar test||Null hypothesis: there is no difference in the proportion of subjects who had pain relief when treating early, as compared to treating late.||||1.000
73886050|NCT02670811|147305741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
73886051|NCT02670811|147305741|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), was analyzed using a paired student t test.|t-test, 2 sided|||||||<0.05
73886052|NCT02670811|147305742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, diastolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
73886053|NCT02670811|147305743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, total cholesterol (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
73886054|NCT02670811|147305744|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, low density lipoprotein (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
73886055|NCT02670811|147305745|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, high density lipoproteins (mg/dL), between groups were analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
73886056|NCT02670811|147305746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, triglycerides (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
73886057|NCT03081117|147305762|SUPERIORITY|||||||0.669|||||||Fisher Exact|||Analysis of Enrolled group.||||0.669
73886058|NCT03081117|147305763|SUPERIORITY||Mean Difference (Net)|-0.3914||||0.0366|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 14||Analysis for Intent-to-Treat group.||||0.0366
73886059|NCT03081117|147305763|SUPERIORITY||Mean Difference (Net)|-0.5146||||0.0103|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 12||Analysis for Per Protocol group.||||0.0103
73886060|NCT03081117|147305766|SUPERIORITY||||||>|0.25||||||The threshold for statistical significance was p = 0.05.|Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
73886061|NCT03081117|147305767|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
73886062|NCT03081117|147305768|SUPERIORITY||Unstandardized beta coefficient|-0.32|STANDARD_ERROR_OF_MEAN|0.27||0.244|TWO_SIDED||||||Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||0.244
73886063|NCT03081117|147305769|SUPERIORITY||||||>|0.25||||||The threshold for statistical significance was p = 0.05.|Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
73886064|NCT03081117|147305770|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
73886065|NCT03081117|147305771|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
73886066|NCT03081117|147305772|SUPERIORITY||Mean Difference (Net)|0.0031351||||0.366|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 13||Analysis for All Available group (participants who had both Baseline and Week 24 scans).||||0.366
73886067|NCT03081117|147305772|SUPERIORITY||Mean Difference (Net)|0.0025586||||0.505|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees fo freedom = 10||Analysis for Per Protocol group.||||0.505
73886068|NCT03081117|147305773|SUPERIORITY||Mean Difference (Net)|0.00000061||||0.98|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 13||Analysis for All Available group (participants who had both Baseline and Week 24 scans).||||0.98
73886069|NCT03081117|147305773|SUPERIORITY||Mean Difference (Net)|-0.0000054||||0.86|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 10||Analysis for Per Protocol group.||||0.86
73886070|NCT00124943|147305776|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||0.396
73886071|NCT00124943|147305777|SUPERIORITY_OR_OTHER|||||||0.783||95.0|||||Fisher Exact|||Comparison of the number of patients with any treatment emergent adverse event. The statistical testing of treatment difference is for exploratory purposes.||||0.783
73886072|NCT00124943|147305778|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||Fisher Exact|||Comparison of in-stent binary restenosis. The statistical testing of treatment difference is for exploratory purposes.||||0.293
73886073|NCT00124943|147305778|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Fisher Exact|||Comparison of in-segment binary restenosis. The statistical testing of treatment difference is for exploratory purposes||||0.400
73886074|NCT00124943|147305779|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||>0.999
73886075|NCT00124943|147305780|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||0.061
73886076|NCT00124943|147305781|SUPERIORITY_OR_OTHER|||||||0.709||95.0|||||Fisher Exact|||Comparison of in-stent late lumen loss. The statistical testing of treatment difference is for exploratory purposes.||||0.709
73886077|NCT00124943|147305781|SUPERIORITY_OR_OTHER|||||||0.495||95.0|||||Fisher Exact|||Comparison of in-segment late lumen loss. The statistical testing of treatment difference is for exploratory purposes.||||0.495
73886078|NCT00124943|147305782|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||ANOVA|P-value testing dose group differences based on an analysis of variance with dose effect in the model.||||||0.317
73888563|NCT01929317|147309712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.65|1.04|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 2."|||1.04|-1.65|
73886079|NCT00321620|147305783|NON_INFERIORITY_OR_EQUIVALENCE|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves as least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82||||0.0002||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy)|||0.95|0.71|0.0002
73886080|NCT00321620|147305784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0085||95.0|0.71|0.95|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).|||0.95|0.71|0.0085
73886081|NCT00321620|147305785|SUPERIORITY_OR_OTHER||Rate ratio|0.82||||0.0085||95.0|0.71|0.94|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).|||0.94|0.71|0.0085
73886082|NCT02844569|147305786|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
73886083|NCT02844569|147305787|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
73886084|NCT02844569|147305788|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
73886085|NCT01122238|147305819|SUPERIORITY_OR_OTHER|||||||0.665|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.665
73886086|NCT01122238|147305819|SUPERIORITY_OR_OTHER|||||||0.562|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.562
73886087|NCT01122238|147305819|SUPERIORITY_OR_OTHER|||||||0.536|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.536
73886088|NCT01122238|147305819|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.206
73886089|NCT01122238|147305820|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|0.0||||0.98|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.98
74077974|NCT00730691|147709897|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.843||0.719|TWO_SIDED|95.0|-1.96|1.35||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||1.35|-1.96|0.719
74077975|NCT00730691|147709897|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.848||0.642|TWO_SIDED|95.0|-2.06|1.27||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||1.27|-2.06|0.642
74077976|NCT00730691|147709897|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.869||0.003|TWO_SIDED|95.0|-4.3|-0.89|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.89|-4.30|0.003
74077977|NCT00730691|147709898|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.511||0.83|TWO_SIDED|95.0|-0.89|1.11|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.11|-0.89|0.830
73886090|NCT01122238|147305820|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|-0.04||||0.4|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.40
73886091|NCT01122238|147305820|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|0.0||||0.99|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.99
73888564|NCT01929317|147309712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-1.34|1.45|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 4."|||1.45|-1.34|
74077978|NCT00730691|147709898|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.51||0.643|TWO_SIDED|95.0|-1.24|0.77||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.77|-1.24|0.643
74077979|NCT00730691|147709898|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.517||0.036|TWO_SIDED|95.0|-2.1|-0.07||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.07|-2.10|0.036
74077980|NCT00730691|147709898|SUPERIORITY_OR_OTHER||LS mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.527||0.004|TWO_SIDED|95.0|-2.58|-0.5|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.50|-2.58|0.004
74077981|NCT00730691|147709899|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.129||0.407|TWO_SIDED|95.0|-0.36|0.15|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.15|-0.36|0.407
74077982|NCT00730691|147709899|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.129||0.533|TWO_SIDED|95.0|-0.33|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.17|-0.33|0.533
74077983|NCT00730691|147709899|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.491|TWO_SIDED|95.0|-0.34|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.17|-0.34|0.491
74077984|NCT00730691|147709899|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.133||0.001|TWO_SIDED|95.0|-0.7|-0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.17|-0.70|0.001
74077985|NCT00730691|147709900|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.765||0.652|TWO_SIDED|95.0|-1.16|1.85|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.85|-1.16|0.652
74077986|NCT00730691|147709900|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.754||0.511|TWO_SIDED|95.0|-1.98|0.98|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.98|-1.98|0.511
74077987|NCT00730691|147709900|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.736||0.204|TWO_SIDED|95.0|-2.38|0.51|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.51|-2.38|0.204
74077988|NCT00730691|147709900|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.781||0.001|TWO_SIDED|95.0|-4.1|-1.03|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-1.03|-4.10|0.001
74077989|NCT00730691|147709901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.114||||0.641|TWO_SIDED|95.0|0.709|1.75|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.750|0.709|0.641
74077990|NCT00730691|147709901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.016||||0.945|TWO_SIDED|95.0|0.643|1.605|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.605|0.643|0.945
74077991|NCT00730691|147709901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.114||||0.641|TWO_SIDED|95.0|0.709|1.749|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.749|0.709|0.641
74077992|NCT00730691|147709901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.427||||0.124|TWO_SIDED|95.0|0.907|2.246|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||2.246|0.907|0.124
74077993|NCT00730691|147709902|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.346||0.064|TWO_SIDED|95.0|-5.15|0.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.14|-5.15|0.064
74077994|NCT00730691|147709902|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|1.353||0.096|TWO_SIDED|95.0|-4.92|0.4|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.40|-4.92|0.096
74077995|NCT00730691|147709902|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|1.397||0.25|TWO_SIDED|95.0|-4.36|1.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.14|-4.36|0.250
74077996|NCT00730691|147709902|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.54|STANDARD_ERROR_OF_MEAN|1.425||0.002|TWO_SIDED|95.0|-7.34|-1.73|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-1.73|-7.34|0.002
73886092|NCT01122238|147305820|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|-0.04||||0.33|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.33
74077997|NCT02554890|147709915|OTHER||expon. back transformed from LS means|0.7143|||<|0.0001|TWO_SIDED|95.0|0.6315|0.808||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||0.8080|0.6315|<.0001
74077998|NCT02554890|147709919|OTHER||exponentially back transformed from LS m|0.8487||||0.0011|TWO_SIDED|95.0|0.7694|0.9361|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||0.9361|0.7694|0.0011
74077999|NCT02554890|147709920|OTHER||expon. back transformed from LS means|1.6487|||<|0.0001|TWO_SIDED|95.0|1.4559|1.8669|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.8669|1.4559|<.0001
74078000|NCT02554890|147709921|OTHER||expon. back transformed from LS means|1.4186|||<|0.0001|TWO_SIDED|95.0|1.3248|1.519|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.5190|1.3248|<.0001
74078001|NCT02554890|147709922|OTHER||expon. back transformed from LS means|1.4745|||<|0.0001|TWO_SIDED|95.0|1.3752|1.581|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.5810|1.3752|<.0001
74078002|NCT02554890|147709923|OTHER||expon. back transformed from LS means|0.7133|||<|0.0001|TWO_SIDED|95.0|0.6171|0.8245||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/Valsartan vs. Enalapril|||0.8245|0.6171|<.0001
74078003|NCT03649477|147709924|SUPERIORITY||Mean Difference (Net)|-1.202||||0.3493|TWO_SIDED|95.0|-3.729|1.324||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.324|-3.729|0.3493
74078004|NCT03649477|147709924|SUPERIORITY||Mean Difference (Net)|-3.136||||0.0162|TWO_SIDED|95.0|-5.685|-0.586||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.586|-5.685|0.0162
74078005|NCT03649477|147709925|SUPERIORITY||Mean Difference (Net)|-0.608||||0.6001|TWO_SIDED|95.0|-2.89|1.674||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.674|-2.890|0.6001
74078006|NCT03649477|147709925|SUPERIORITY||Mean Difference (Net)|-0.764||||0.5143|TWO_SIDED|95.0|-3.068|1.541||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.541|-3.068|0.5143
74078007|NCT03649477|147709926|SUPERIORITY||Mean Difference (Net)|0.183||||0.9144|TWO_SIDED|95.0|-3.175|3.541||0.05 threshold for statistical significance|Mixed Models Analysis|||||3.541|-3.175|0.9144
74078008|NCT03649477|147709926|SUPERIORITY||Mean Difference (Net)|-3.812||||0.0266|TWO_SIDED|95.0|-7.177|-0.446||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.446|-7.177|0.0266
74078009|NCT03649477|147709927|SUPERIORITY||Mean Difference (Net)|-0.312||||0.1598|TWO_SIDED|95.0|-0.748|0.125||0.05 threshold for statistical significance|Mixed Models Analysis|||||0.125|-0.748|0.1598
74078010|NCT03649477|147709927|SUPERIORITY||Mean Difference (Net)|-0.498||||0.0266|TWO_SIDED|95.0|-0.937|-0.059||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.059|-0.937|0.0266
74078011|NCT03649477|147709928|SUPERIORITY||Mean Difference (Net)|-1.085||||0.2479|TWO_SIDED|95.0|-2.932|0.761||0.05 threshold for statistical significance|Mixed Models Analysis|||||0.761|-2.932|0.2479
74078012|NCT03649477|147709928|SUPERIORITY||Mean Difference (Net)|-2.412||||0.0114|TWO_SIDED|95.0|-4.276|-0.548||0.05 for statistical significance|Mixed Models Analysis|||||-0.548|-4.276|0.0114
74078013|NCT01097577|147709949|SUPERIORITY|||||||0.18|||||||ANOVA|||This study was designed to determine if pregabalin is an effective regimen for postoperative pain control following PRK. We hypothesized that there will be at least a 10% improvement in pain after PRK using a scheduled pregabalin dosing regimen compared to placebo. A power analysis was completed to determine the number of patients necessary.||||0.180
74078014|NCT01097577|147709950|SUPERIORITY|||||||0.207|||||||ANOVA|||||||0.207
74078015|NCT01097577|147709951|SUPERIORITY|||||||0.283|||||||ANOVA|||||||0.283
74078016|NCT01097577|147709952|SUPERIORITY|Question 1: Pain at its worst||||||0.223|||||||ANOVA|||||||0.223
74078017|NCT01097577|147709953|SUPERIORITY|||||||0.311|||||||ANOVA|||||||0.311
74078018|NCT01097577|147709954|SUPERIORITY|||||||0.581|||||||t-test, 2 sided|||Days to Heal, OD||||0.581
74078019|NCT01097577|147709954|SUPERIORITY|||||||0.307|||||||t-test, 2 sided|||Days to Heal, OS||||0.307
74078020|NCT00748072|147709964|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45||||0.01|TWO_SIDED|95.0|0.24|0.85|||Chi-squared|||The sample size was calculated by the difference in post-biopsy bleeding complications. Since the presence of bleeding was demonstrated in about 30-40 % in our previous observational study, we hypothesized a reduction risk of 0.50 and an absolute reduction of risk from 0.40 to 0.20. The sample size of the study for a power of 0.80 and a significance level \<0.05 was calculated in 158 patients.||0.85|0.24|0.01
74078021|NCT04493684|147710034|OTHER||Geometric Least Square Mean Ratio|2.462|||||TWO_SIDED|90.0|1.823|3.323|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-24). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||3.323|1.823|
74078022|NCT04493684|147710034|OTHER||Geometric Least Square Mean Ratio|1.381|||||TWO_SIDED|90.0|1.223|1.56|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-24). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.56|1.223|
74078023|NCT04493684|147710035|OTHER||Geometric Least Square Mean Ratio|2.103|||||TWO_SIDED|90.0|1.629|2.717|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-inf). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||2.717|1.629|
74078024|NCT04493684|147710035|OTHER||Geometric Least Square Mean Ratio|1.351|||||TWO_SIDED|90.0|1.22|1.497|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-inf). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.497|1.22|
74078025|NCT04493684|147710036|OTHER||Geometric Least Square Mean Ratio|2.307|||||TWO_SIDED|90.0|1.668|3.19|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter Cmax. Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||3.19|1.668|
74078026|NCT04493684|147710036|OTHER||Geometric Least Square Mean Ratio|1.372|||||TWO_SIDED|90.0|1.19|1.582|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter Cmax. Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.582|1.19|
74078027|NCT04870606|147710102|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.0181|ONE_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0181
74078028|NCT04870606|147710103|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.1223|ONE_SIDED||||||Chi-squared|||||||0.1223
74078029|NCT04870606|147710104|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.0038|ONE_SIDED||||||t-test, 2 sided|||||||0.0038
74078030|NCT05152576|147710107|SUPERIORITY||Rate Difference|41.4|||<|0.001|TWO_SIDED|95.0|23.5|59.3||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||59.3|23.5|<0.001
74078031|NCT05152576|147710107|SUPERIORITY||Rate Difference|38.2|||<|0.001|TWO_SIDED|95.0|19.2|57.1||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||57.1|19.2|<0.001
74078032|NCT05152576|147710107|SUPERIORITY||Rate Difference|41.4|||<|0.001|TWO_SIDED|95.0|23.5|59.3||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||59.3|23.5|<0.001
74078033|NCT01343004|147710115|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74078034|NCT01343004|147710115|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
74078035|NCT01343004|147710116|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
74078036|NCT01343004|147710116|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
74078037|NCT01343004|147710116|SUPERIORITY_OR_OTHER|||||||0.8155|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||0.8155
74078038|NCT01343004|147710117|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
74078039|NCT01343004|147710117|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
74078040|NCT01343004|147710117|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
74078041|NCT01343004|147710118|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
74078042|NCT01343004|147710118|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
74078043|NCT01343004|147710118|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||0.0004
74078044|NCT01343004|147710119|SUPERIORITY_OR_OTHER|||||||0.0318|||||||Chi-squared|||||||0.0318
74078045|NCT01343004|147710119|SUPERIORITY_OR_OTHER|||||||0.2304|||||||Chi-squared|||||||0.2304
74078046|NCT01343004|147710119|SUPERIORITY_OR_OTHER|||||||0.3361|||||||Chi-squared|||||||0.3361
74078047|NCT00526188|147710124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.46||||||95.0|6.0|12.93|||Test performed based on the 95% CI||Comparison was post-contrast MRI minus pre-contrast MRI|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image set was calculated. Null hypothesis: No difference between post- and pre-contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided. The study was planned with a power of 80%.||12.93|6.00|
74078048|NCT00526188|147710125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.81||||||95.0|1.84|7.78|||Test performed based on the 95% CI||Comparison was post-contrast MRI minus pre-contrast MRI (for investigator's result)|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image sets, based on investigators assessments was calculated. Null hypothesis: No difference between post and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the investigators difference. This CI had a confidence level of 95% and was two-sided.||7.78|1.84|
74078049|NCT00526188|147710126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.36||||||95.0|7.45|15.28|||Test performed based on the 95% CI||Comparison was combined pre- and post-contrast MRI minus pre-contrast MRI|Difference in precision of lesion characterization between combined pre and post contrast MRI and pre contrast MRI image set was calculated. Null hypothesis: No difference between combined pre- and post-contrast MRI and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided.||15.28|7.45|
74078050|NCT02222818|147710152|NON_INFERIORITY_OR_EQUIVALENCE|In order to demonstrate that CAFRPlus is no less effective than CAFR by a non-inferiority margin of 2%, assuming a true paired difference of 6% and a standard deviation of 15% for the paired differences, a sample size of 39 subjects with paired data is required to achieve 90% statistical power using the one-sample t-test for non-inferiority, while controlling the one-sided type I error rate at 0.025.|Mean Difference (Net)|7.0|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ -2% Alternative Hypothesis (Ha): μd \> -2% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects' paired measurements from the two cross-over follow-up periods, and -2% is the non-inferiority margin selected based upon clinical judgment.||9.5|4.5|<0.0001
74078051|NCT02222818|147710153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ 0% Alternative Hypothesis (Ha): μd \> 0% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects' paired measurements from the two cross-over follow-up periods.||9.5|4.5|<0.0001
74078052|NCT04516434|147710184|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
74078053|NCT04516434|147710184|OTHER|Descriptive analysis||||||0.99|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.99
74078054|NCT04516434|147710185|OTHER|Descriptive analysis||||||0.08|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.08
74078055|NCT04516434|147710185|OTHER|Descriptive analysis||||||0.045|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.045
74078056|NCT04516434|147710187|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||First sensation of bladder filling - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||1
74078057|NCT04516434|147710187|OTHER|Descriptive analysis||||||0.41|||||||Mixed Models Analysis|||First sensation of bladder filling - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||0.41
74078058|NCT04516434|147710187|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Maximum cystometric capacity - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||1
74078059|NCT04516434|147710187|OTHER|Descriptive analysis||||||0.01|||||||Mixed Models Analysis|||Maximum cystometric capacity - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||0.01
74078060|NCT04516434|147710188|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
74078061|NCT04516434|147710188|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
74078062|NCT04516434|147710189|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
74078063|NCT04516434|147710189|OTHER|Descriptive analysis||||||0.99|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.99
74078064|NCT04278560|147710195|SUPERIORITY||Mean Difference (Net)|385.3||||0.009|TWO_SIDED|||||Repeated Measures Two-Way ANOVA: Group, Time, Group x Time, and controlled by Baseline Step Counts|ANOVA|||||||0.009
74078065|NCT04278560|147710196|SUPERIORITY||Mean Difference (Net)|1.2||||0.03|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.03
74078066|NCT04278560|147710197|SUPERIORITY||Mean Difference (Net)|0.19||||0.4|TWO_SIDED||||||ANOVA|We used change from baseline for the analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.4
74078067|NCT04278560|147710198|SUPERIORITY||Mean Difference (Net)|3.1||||0.016|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.016
74078068|NCT04278560|147710199|SUPERIORITY||Mean Difference (Net)|9.94||||0.17|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.17
74078069|NCT04278560|147710200|SUPERIORITY||Median Difference (Net)|0.6||||0.1|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.1
74078070|NCT04278560|147710201|SUPERIORITY||Median Difference (Net)|0.07||||0.7|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline||||||0.7
74078071|NCT04278560|147710202|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
74078072|NCT04278560|147710203|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||0.16
74078073|NCT02832063|147710206|EQUIVALENCE|Primary efficacy power calculations assume a \>25% difference between B244 treatment and placebo and a 15% dropout. Each of the endpoints comprising the co-primary endpoint will be tested at an alpha level of p\<0.05. In order to achieve 90% power with a 5% Type I error rate, a total of 372 participants is required.||||||0.034|||||||ANCOVA|||||||0.034
74078074|NCT02849457|147710269|SUPERIORITY||Mean Difference (Final Values)|-0.6565|STANDARD_ERROR_OF_MEAN|3.9332||0.8681|TWO_SIDED|95.0|-8.5567|7.2436|||Mixed Models Analysis|Adjusted for age (\<=7 vs \>7 months) at randomization and sex. Unstructured covariance used among 12 and 24 month outcomes.|Parameter represents estimated amount difference in group means. Negative value represents higher mean in placebo group.|||7.2436|-8.5567|0.8681
74078075|NCT02849457|147710270|SUPERIORITY|||||||0.7375|||||||Chi-squared|||||||0.7375
74078076|NCT02849457|147710271|SUPERIORITY||Hazard Ratio (HR)|0.593||||0.1174|TWO_SIDED|95.0|0.309|1.14|||Regression, Cox|Adjusted for age (\<=7 vs \>7 months) at randomization and sex.||||1.140|0.309|0.1174
74078077|NCT02849457|147710272|OTHER|Two-sided test of non-equivalence||||||0.4653|||||||Chi-squared|||||||0.4653
74078078|NCT02849457|147710273|SUPERIORITY||Mean Difference (Final Values)|-4.4392|STANDARD_ERROR_OF_MEAN|3.1889||0.1697|TWO_SIDED|95.0|-10.8346|1.9562|||Mixed Models Analysis|Adjusted for age at randomization (\<=7 vs \>7 months) and sex. Unstructured covariance used among 12, 24, and 36 month outcomes.|Pertains to the estimated difference in mean score between groups at study visit corresponding to 24 months of age.|||1.9562|-10.8346|0.1697
74078079|NCT03673670|147710277|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.021||||0.168|TWO_SIDED|95.0|0.991|1.052|||ANCOVA|||||1.052|0.991|0.168
74078080|NCT03673670|147710277|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|0.995||||0.731|TWO_SIDED|95.0|0.966|1.025|||ANCOVA|||||1.025|0.966|0.731
74078081|NCT03673670|147710278|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.115|TWO_SIDED|95.0|0.994|1.055|||ANCOVA|||||1.055|0.994|0.115
74078082|NCT03673670|147710278|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.111|TWO_SIDED|95.0|0.994|1.055|||ANCOVA|||||1.055|0.994|0.111
74078083|NCT03673670|147710279|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.014||||0.303|TWO_SIDED|95.0|0.987|1.043|||ANCOVA|||||1.043|0.987|0.303
74078084|NCT03673670|147710280|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.027||||0.067|TWO_SIDED|95.0|0.998|1.057|||ANCOVA|||||1.057|0.998|0.067
74078085|NCT03673670|147710280|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.395|TWO_SIDED|95.0|0.984|1.042|||ANCOVA|||||1.042|0.984|0.395
74078086|NCT03673670|147710281|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.404|TWO_SIDED|95.0|0.984|1.039|||ANCOVA|||||1.039|0.984|0.404
74078087|NCT03673670|147710282|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.082||||0.001|TWO_SIDED|95.0|1.043|1.123|||ANCOVA|||||1.123|1.043|0.001
74078088|NCT03673670|147710282|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.061||||0.002|TWO_SIDED|95.0|1.023|1.101|||ANCOVA|||||1.101|1.023|0.002
74078089|NCT03673670|147710283|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.02||||0.096|TWO_SIDED|95.0|0.997|1.043|||ANCOVA|||||1.043|0.997|0.096
74078090|NCT03673670|147710283|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.002||||0.862|TWO_SIDED|95.0|0.979|1.025|||ANCOVA|||||1.025|0.979|0.862
74078091|NCT03673670|147710284|OTHER||Median Difference (Final Values)|0.0||||0.945|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.945
74078092|NCT03673670|147710284|OTHER||Median Difference (Final Values)|0.0||||0.501|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.501
74078093|NCT02777580|147710291|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
74078094|NCT02777580|147710292|OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.62|1.48||||||||1.48|0.62|
74078095|NCT02777580|147710293|OTHER||Risk Ratio (RR)|4.57|||||TWO_SIDED|95.0|0.58|35.8||||||||35.8|0.58|
74078096|NCT02777580|147710294|OTHER||Risk Ratio (RR)|1.27|||||TWO_SIDED|95.0|0.25|6.48||||||||6.48|0.25|
73886093|NCT01709721|147305839|SUPERIORITY|||||||0.147|||||||Chi-squared|Pearson's chi-square test||Superiority of intrathecal hydromorphone hydrochloride as compared to a control arm.||||0.147
74078097|NCT02558491|147710428|OTHER|||||||0.045||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.045
74078098|NCT02558491|147710428|OTHER|||||||0.07||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.07
74078099|NCT02558491|147710428|OTHER|||||||0.177||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.177
74078100|NCT02558491|147710429|OTHER|||||||0.042||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test was used. Data were first binned (to ensure minimum count of five per bins) \& w2 statistics was used with expected counts given by standard of care. Based on achieved recruitment, moderate effect size (0.3) was detectable with 80% power, or large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.042
74078101|NCT02558491|147710429|OTHER|||||||0.276||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.276
74078102|NCT02558491|147710430|OTHER|||||||0.026||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.026
74078103|NCT02558491|147710430|OTHER|||||||0.173||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.173
74078104|NCT02558491|147710430|OTHER|||||||0.715||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.715
74078105|NCT02558491|147710431|OTHER|||||||0.036||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.036
74078106|NCT02558491|147710431|OTHER|||||||0.213||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.213
74078107|NCT02558491|147710431|OTHER|||||||0.11||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.110
74078108|NCT02558491|147710432|OTHER|||||||0.018||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.018
74078109|NCT02558491|147710432|OTHER|||||||0.149||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.149
74078110|NCT02558491|147710432|OTHER|||||||0.109||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.109
74078111|NCT02558491|147710433|OTHER|||||||0.78||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.78
74078112|NCT02558491|147710433|OTHER|||||||0.399||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.399
74078113|NCT02558491|147710433|OTHER|||||||0.824||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.824
74078114|NCT02558491|147710434|OTHER|||||||0.863||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.863
74078115|NCT02558491|147710434|OTHER|||||||0.965||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.965
74078116|NCT02558491|147710434|OTHER|||||||0.742||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.742
73886094|NCT01709721|147305840|SUPERIORITY|||||||0.0342|||||||ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0342
74078117|NCT02558491|147710435|OTHER|||||||0.158||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.158
74078118|NCT02558491|147710435|OTHER|||||||0.085||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.085
74078119|NCT02558491|147710435|OTHER|||||||0.055||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.055
74078120|NCT02558491|147710436|OTHER|||||||0.744||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.744
74078121|NCT02558491|147710436|OTHER|||||||0.248||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.248
74078122|NCT02558491|147710436|OTHER|||||||0.225||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.225
74078123|NCT02558491|147710437|OTHER|||||||0.86||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.86
74078124|NCT02558491|147710437|OTHER|||||||0.522||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.522
74078125|NCT02558491|147710437|OTHER|||||||0.522||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.522
74078126|NCT02558491|147710438|OTHER|||||||0.301||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.301
74078127|NCT02558491|147710439|OTHER|||||||0.189||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.189
74078128|NCT02558491|147710440|OTHER|||||||0.271||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.271
74078129|NCT00834431|147710443|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.0||||||90.0|85.9|98.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.6|85.9|
74078130|NCT00834431|147710444|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|96.2|
74078131|NCT00834431|147710445|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.7||||||90.0|96.3|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|96.3|
74078132|NCT05630885|147710457|SUPERIORITY||Slope|0.984||||0.65|TWO_SIDED|95.0|0.916|1.056||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use. Analysis used multiple imputation for missing data.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel, adjusting for statin-use. The study was powered to detect a between-group difference of 0.046 in log10 MDS TBR (10% relative fold-change), assuming a null difference of 0 in log10 MDS TBR (a ratio of 1 in absolute-scale), a standard deviation of 0.065 of change in log10 TBR, and 75 evaluable participants.||1.056|0.916|0.65
74078133|NCT05630885|147710457|OTHER|Statistical test for interaction.||||||0.4||||||P-value for modification of the CVC treatment effect by subgroups defined by statin-use is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by statin-use at study entry (use versus no-use).||||0.40
74078134|NCT05630885|147710457|OTHER|Statistical test for interaction.||||||0.63||||||P-value for modification of the CVC treatment effect by subgroups defined by sex is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for sex (F vs M) and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by sex (female versus male).||||0.63
74078135|NCT05630885|147710457|OTHER|Statistical test for interaction.||||||0.71||||||P-value for modification of the CVC treatment effect by subgroups defined by race is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for race and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by race (Black/African-American versus Non-Black/African-American).||||0.71
74078136|NCT05630885|147710458|SUPERIORITY||Slope|0.996||||0.91|TWO_SIDED|95.0|0.93|1.067||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the aorta adjusting for statin-use.||1.067|0.930|0.91
74078137|NCT05630885|147710458|SUPERIORITY||Slope|0.98||||0.64|TWO_SIDED|95.0|0.901|1.066||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the right and left carotid arteries adjusting for statin-use.||1.066|0.901|0.64
74078138|NCT05630885|147710459|SUPERIORITY||Slope|1.01||||0.79|TWO_SIDED|95.0|0.939|1.087||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the aorta adjusting for statin-use.||1.087|0.939|0.79
74078139|NCT05630885|147710459|SUPERIORITY||Slope|1.017||||0.69|TWO_SIDED|95.0|0.935|1.106||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the right and left carotid arteries adjusting for statin-use.||1.106|0.935|0.69
74078140|NCT05630885|147710460|SUPERIORITY||Slope|2.5||||0.49|TWO_SIDED|95.0|-4.6|9.6||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in fasting glucose from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of fasting glucose adjusting for statin-use.||9.6|-4.6|0.49
74078141|NCT05630885|147710461|SUPERIORITY||Slope|1.07||||0.62|TWO_SIDED|95.0|0.81|1.43||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in fasting insulin from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of fasting insulin adjusting for statin-use.||1.43|0.81|0.62
74078142|NCT05630885|147710461|SUPERIORITY||Slope|1.09||||0.61|TWO_SIDED|95.0|0.78|1.54||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in HOMA-IR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of HOMA-IR adjusting for statin-use.||1.54|0.78|0.61
74078143|NCT05630885|147710462|SUPERIORITY||Slope|0.97||||0.91|TWO_SIDED|95.0|0.62|1.52||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in hsCRP from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of hsCRP adjusting for statin-use.||1.52|0.62|0.91
74078144|NCT05630885|147710462|SUPERIORITY||Slope|1.01||||0.94|TWO_SIDED|95.0|0.77|1.33||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in IL-6 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of IL-6 adjusted for statin-use.||1.33|0.77|0.94
74078145|NCT05630885|147710462|SUPERIORITY||Slope|4.74|||<|0.001|TWO_SIDED|95.0|3.89|5.77||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MCP-1 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of MCP-1 adjusting for statin-use.||5.77|3.89|<0.001
74078146|NCT05630885|147710463|SUPERIORITY||Slope|-49.0||||0.38|TWO_SIDED|95.0|-158.0|60.0||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in sCD14 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of sCD14 adjusting for statin-use.||60|-158|0.38
74078147|NCT05630885|147710463|SUPERIORITY||Slope|-6.3||||0.88|TWO_SIDED|95.0|-87.0|75.0||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in sCD163 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of sCD163 adjusting for statin-use.||75|-87|0.88
74078148|NCT05630885|147710464|SUPERIORITY||Slope|1.65|||<|0.001|TWO_SIDED|95.0|1.28|2.12||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MIP-1 beta from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of MIP-1 beta adjusting for statin-use.||2.12|1.28|<0.001
74078149|NCT05630885|147710464|SUPERIORITY||Slope|1.02||||0.85|TWO_SIDED|95.0|0.82|1.28||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in RANTES from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of RANTES adjusting for statin-use.||1.28|0.82|0.85
74078150|NCT03466866|147710483|SUPERIORITY||Incidence rate ratio|0.67||||0.12|TWO_SIDED|95.0|0.42|1.07|||Poisson regression|We adjusted for stratification variables, sex, baseline MOCA, number of medical conditions, PSQ Communication, and PSQ General satisfaction.||We used Poisson regression to model the number of outcome events as a function of randomization assignment, adjusting for the stratification variables and using follow-up time as the offset term. We calculated estimates of annual rates of the primary outcome and the adjusted estimate of the rate ratio. We evaluated the primary hypothesis by testing the null hypothesis that the rate ratio for randomization assignment equals 1.||1.07|.42|.12
74078151|NCT03466866|147710484|SUPERIORITY|General Satisfaction|Mean Difference (Final Values)|0.11||||0.502|TWO_SIDED|95.0|-0.22|0.45|||Regression, Linear|||We modeled PSQ- scores as continuous variables to estimate average change over time by treatment group. We used mixed effects linear regression with fixed effects for time (baseline, and months 6 and 12), randomization assignment, and time by randomization interaction. A random intercept term and an appropriate covariance structure was used to account for correlation among repeated measurements.||.45|-.22|.502
74078152|NCT03466866|147710485|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.23|TWO_SIDED|95.0|0.16|0.69|||ANCOVA|||Analysis of covariance was performed with Number of Quality Metrics as the dependent variable, treatment arm as the main independent variable of interest and the stratification variables as adjusting variables.||.69|.16|.23
74078153|NCT03466866|147710486|SUPERIORITY||Mean Difference (Net)|4.45||||0.094|TWO_SIDED|95.0|-0.76|9.66|||Mixed Models Analysis|||We used mixed effects linear regression. Fixed effects included time (baseline, and months 6 and 12), randomization assignment, time by randomization interaction, and the three stratification variables. From the results of this model, we estimated the mean change from baseline to 6 months, 6 months to 12 months and baseline to 12 months within each treatment group. We then compared the change from baseline to 12 months between the two groups.||9.66|-.76|.094
74078154|NCT00318461|147710507|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-1.09|||<|0.0001||95.0|-1.3|-0.88|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.88|-1.30|<0.0001
74078155|NCT00318461|147710507|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.02|||<|0.0001||95.0|-0.19|0.15|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.15|-0.19|<0.0001
74078156|NCT00318461|147710507|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.06|||<|0.0001||95.0|-1.27|-0.85|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.85|-1.27|<0.0001
74078157|NCT00318461|147710507|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.01|||<|0.0001||95.0|-0.16|0.18|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.18|-0.16|<0.0001
74078158|NCT00318461|147710507|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.78|||<|0.0001||95.0|-0.99|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.57|-0.99|<0.0001
74078159|NCT00318461|147710507|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.29||||0.1026||95.0|0.12|0.46|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.46|0.12|0.1026
74078160|NCT00318461|147710507|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of glimepiride+metformin to metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.07|||<|0.0001||95.0|-1.28|-0.86|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.86|-1.28|<0.0001
74078161|NCT00318461|147710508|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.29||||0.0016||95.0|-2.16|-0.41|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.41|-2.16|0.0016
74078162|NCT00318461|147710508|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.75|||<|0.0001||95.0|-4.48|-3.01|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-3.01|-4.48|<0.0001
74078163|NCT00318461|147710508|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.07||||0.0117||95.0|-1.94|-0.19|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.19|-1.94|0.0117
74078164|NCT00318461|147710508|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.53|||<|0.0001||95.0|-4.27|-2.79|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.79|-4.27|<0.0001
74078165|NCT00318461|147710508|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28||||0.8198||95.0|-1.15|0.6|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.60|-1.15|0.8198
74078166|NCT00318461|147710508|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.73|||<|0.0001||95.0|-3.47|-2.0|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.00|-3.47|<0.0001
74078167|NCT00318461|147710509|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.11||||0.0378||95.0|-2.18|-0.05|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.05|-2.18|0.0378
74078168|NCT00318461|147710509|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.61|||<|0.0001||95.0|-4.51|-2.72|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.72|-4.51|<0.0001
74078169|NCT00318461|147710509|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.23||||0.0185||95.0|-2.3|-0.16|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.16|-2.30|0.0185
74078170|NCT00318461|147710509|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.73|||<|0.0001||95.0|-4.64|-2.83|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.83|-4.64|<0.0001
74078171|NCT00318461|147710509|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.27||||0.9069||95.0|-1.33|0.8|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.80|-1.33|0.9069
74078172|NCT00318461|147710509|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.77|||<|0.0001||95.0|-3.67|-1.87|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-1.87|-3.67|<0.0001
74078173|NCT00318461|147710510|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.09|||<|0.0001||95.0|-2.68|-1.5|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.50|-2.68|<0.0001
74078174|NCT00318461|147710510|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.38||||0.1845||95.0|-0.87|0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.11|-0.87|0.1845
74078175|NCT00318461|147710510|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.04|||<|0.0001||95.0|-2.63|-1.44|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.44|-2.63|<0.0001
74078176|NCT00318461|147710510|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.33||||0.3047||95.0|-0.82|0.17|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.||0.17|-0.82|0.3047
74078177|NCT00318461|147710510|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.53|||<|0.0001||95.0|-2.12|-0.94|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-0.94|-2.12|<0.0001
74078178|NCT00318461|147710510|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.18||||0.8079||95.0|-0.32|0.67|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.67|-0.32|0.8079
74078179|NCT00318461|147710511|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.93|||<|0.0001||95.0|-2.58|-1.28|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.28|-2.58|<0.0001
74078180|NCT00318461|147710511|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.53||||0.0542||95.0|-1.08|0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.01|-1.08|0.0542
74078181|NCT00318461|147710511|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.30|-2.60|<0.0001
74078182|NCT00318461|147710511|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.55||||0.0451||95.0|-1.1|-0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.||-0.01|-1.10|0.0451
74078183|NCT00318461|147710511|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.55|||<|0.0001||95.0|-2.2|-0.9|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-0.90|-2.20|<0.0001
74078184|NCT00318461|147710511|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.9006||95.0|-0.7|0.39|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.39|-0.70|0.9006
74078185|NCT00318461|147710512|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.13||||0.8871||95.0|-0.62|0.36|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.36|-0.62|0.8871
74078186|NCT00318461|147710512|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.12||||0.8695||95.0|-0.51|0.27|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.27|-0.51|0.8695
74078187|NCT00318461|147710512|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.03||||0.9994||95.0|-0.46|0.52|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.52|-0.46|0.9994
74078188|NCT00318461|147710512|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.04||||0.9984||95.0|-0.35|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.43|-0.35|0.9984
74078189|NCT00318461|147710512|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.6201||95.0|-0.28|0.7|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.70|-0.28|0.6201
74078190|NCT00318461|147710512|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.4831||95.0|-0.18|0.6|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.60|-0.18|0.4831
74078191|NCT00318461|147710513|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.83|||<|0.0001||95.0|-1.07|-0.59|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.59|-1.07|<0.0001
74078192|NCT00318461|147710513|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.08|||<|0.0001||95.0|-0.28|0.12|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.12|-0.28|<0.0001
74078193|NCT00318461|147710513|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.81|||<|0.0001||95.0|-1.05|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment was at 104 weeks analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.57|-1.05|<0.0001
73886095|NCT01709721|147305841|SUPERIORITY|||||||0.1642|||||||ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.1642
74078194|NCT00318461|147710513|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.07|||<|0.0001||95.0|-0.27|0.13|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.13|-0.27|<0.0001
74078195|NCT00318461|147710513|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-0.61|||<|0.0001||95.0|-0.85|-0.37|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.37|-0.85|<0.0001
74078196|NCT00318461|147710513|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.14||||0.0052||95.0|-0.06|0.34|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.34|-0.06|0.0052
74078197|NCT00318461|147710513|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of glimepiride+metformin to placebo metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.75|||<|0.0001||95.0|-0.99|-0.51|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.51|-0.99|<0.0001
74078198|NCT00318461|147710514|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.24||||0.5282||95.0|-0.74|0.26|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.26|-0.74|0.5282
74078199|NCT00318461|147710514|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.7644||95.0|-0.55|0.25|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.25|-0.55|0.7644
74078200|NCT00318461|147710514|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.36||||0.2063||95.0|-0.86|0.14|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.14|-0.86|0.2063
74078201|NCT00318461|147710514|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28||||0.2678||95.0|-0.68|0.12|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.12|-0.68|0.2678
74078202|NCT00318461|147710514|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.07||||0.9887||95.0|-0.57|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.43|-0.57|0.9887
74078203|NCT00318461|147710514|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.02||||0.9998||95.0|-0.38|0.42|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.42|-0.38|0.9998
74078204|NCT00318461|147710515|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.30|-2.60|<0.0001
74078205|NCT00318461|147710515|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.11||||0.967||95.0|-0.62|0.41|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.41|-0.62|0.9670
74078206|NCT00318461|147710515|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.72|||<|0.0001||95.0|-2.36|-1.07|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.07|-2.36|<0.0001
74078207|NCT00318461|147710515|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.13||||0.9368||95.0|-0.39|0.64|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.64|-0.39|0.9368
74078208|NCT00318461|147710515|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.06||||0.0003||95.0|-1.71|-0.42|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.42|-1.71|0.0003
74078209|NCT00318461|147710515|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.78||||0.0008||95.0|0.27|1.29|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.29|0.27|0.0008
74078210|NCT00318461|147710516|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.66|||<|0.0001||95.0|-2.37|-0.96|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.96|-2.37|<0.0001
74078211|NCT00318461|147710516|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.3||||0.5048||95.0|-0.86|0.26|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.26|-0.86|0.5048
74078212|NCT00318461|147710516|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.79|||<|0.0001||95.0|-2.49|-1.08|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.08|-2.49|<0.0001
74078213|NCT00318461|147710516|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.42||||0.2005||95.0|-0.98|0.14|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.14|-0.98|0.2005
74078214|NCT00318461|147710516|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.16||||0.0003||95.0|-1.86|-0.46|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.46|-1.86|0.0003
74078215|NCT00318461|147710516|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.7871||95.0|-0.35|0.76|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.76|-0.35|0.7871
74078216|NCT00318461|147710517|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|27.75||||0.0031||95.0|7.83|47.67|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||47.67|7.83|0.0031
74078217|NCT00318461|147710517|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|1.44||||0.9987||95.0|-15.03|17.9|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||17.90|-15.03|0.9987
74078218|NCT00318461|147710517|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|21.96||||0.0263||95.0|2.04|41.87|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||41.87|2.04|0.0263
74078219|NCT00318461|147710517|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.36||||0.9227||95.0|-20.94|12.22|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||12.22|-20.94|0.9227
74078220|NCT00318461|147710517|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|22.08||||0.0253||95.0|2.15|42.01|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||42.01|2.15|0.0253
74078221|NCT00318461|147710517|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.23||||0.9293||95.0|-20.78|12.31|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||12.31|-20.78|0.9293
74078222|NCT00318461|147710518|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|25.71||||0.8821||95.0|-69.84|121.26|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||121.26|-69.84|0.8821
74078223|NCT00318461|147710518|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|6.56||||0.9989||95.0|-72.66|85.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||85.79|-72.66|0.9989
74078224|NCT00318461|147710518|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|35.2||||0.7292||95.0|-60.33|130.72|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||130.72|-60.33|0.7292
74078225|NCT00318461|147710518|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|16.05||||0.9689||95.0|-63.69|95.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||95.79|-63.69|0.9689
74078226|NCT00318461|147710518|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|72.38||||0.1818||95.0|-23.15|167.9|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||167.90|-23.15|0.1818
74078227|NCT00318461|147710518|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|53.23||||0.2978||95.0|-26.3|132.76|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||132.76|-26.30|0.2978
74078228|NCT04134091|147710521|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74078229|NCT04134091|147710521|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74078230|NCT04134091|147710522|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
74078231|NCT04134091|147710522|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
74078232|NCT04134091|147710523|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74078233|NCT04134091|147710523|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
74078234|NCT04134091|147710524|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74078235|NCT04134091|147710524|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
74078236|NCT04134091|147710525|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74078237|NCT04134091|147710525|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74078238|NCT04134091|147710526|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Hepatocyte Ballooning Score||||>0.05
74078239|NCT04134091|147710526|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Outcome Variable: Hepatocyte Ballooning Score||||<0.05
74078240|NCT04134091|147710526|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Lobular Inflammation Score||||>0.05
74078241|NCT04134091|147710526|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Lobular Inflammation Score||||>0.05
74078242|NCT04134091|147710526|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Outcome Variable: Steatosis Score||||<0.01
74078243|NCT04134091|147710526|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Outcome Variable: Steatosis Score||||<0.001
74078244|NCT04134091|147710527|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
74078245|NCT04134091|147710527|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
74078246|NCT04134091|147710528|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
74078247|NCT04134091|147710528|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
74078248|NCT04134091|147710529|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
74078249|NCT04134091|147710529|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
74078250|NCT04134091|147710530|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
74078251|NCT04134091|147710530|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
74078252|NCT04134091|147710531|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
74078253|NCT04134091|147710531|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
74078254|NCT04134091|147710532|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: AST||||>0.05
74078255|NCT04134091|147710532|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||Outcome Variable: AST||||<0.01
74078256|NCT04134091|147710532|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALT||||>0.05
74078257|NCT04134091|147710532|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||Outcome Variable: ALT||||< 0.01
74078258|NCT04134091|147710532|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALP||||>0.05
74078259|NCT04134091|147710532|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALP||||<0.05
74078260|NCT04134091|147710532|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: GGT||||>0.05
74078261|NCT04134091|147710532|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Outcome Variable: GGT||||<0.05
74078262|NCT04134091|147710533|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: Total cholesterol||||>0.05
74078263|NCT04134091|147710533|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: Total cholesterol||||>0.05
74078264|NCT04134091|147710533|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: LDL||||>0.05
74078265|NCT04134091|147710533|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: LDL||||>0.05
74078266|NCT04134091|147710533|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: HDL||||>0.05
74078267|NCT04134091|147710533|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: HDL||||>0.05
74078268|NCT04134091|147710533|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: triglycerides||||>0.05
74078269|NCT04134091|147710533|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: triglycerides||||>0.05
74078270|NCT01929863|147710553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.13|||||TWO_SIDED|95.0|-50.4|-5.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Fasting Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Fasting Value.||-5.86|-50.40|
74078271|NCT01929863|147710553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.16|||||TWO_SIDED|95.0|-51.68|-6.64|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.||-6.64|-51.68|
74078272|NCT01929863|147710553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.58|||||TWO_SIDED|95.0|-62.25|-10.9|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.||-10.90|-62.25|
74078273|NCT01929863|147710553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.41|||||TWO_SIDED|95.0|-72.8|-18.03|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.||-18.03|-72.80|
74078274|NCT01929863|147710553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.35|||||TWO_SIDED|95.0|-50.84|-7.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.||-7.86|-50.84|
74078275|NCT01929863|147710553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.14|||||TWO_SIDED|95.0|-45.8|-6.49|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean||-6.49|-45.80|
74078276|NCT01929863|147710553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.0|||||TWO_SIDED|95.0|-55.41|-8.58|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.||-8.58|-55.41|
74078277|NCT01929863|147710553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-40.96|||||TWO_SIDED|95.0|-66.64|-15.29|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.||-15.29|-66.64|
74078278|NCT01929863|147710553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.76|||||TWO_SIDED|95.0|-54.67|-14.85|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.||-14.85|-54.67|
74078279|NCT01929863|147710554|SUPERIORITY_OR_OTHER||Ratio|1.013|||||TWO_SIDED|90.0|0.912|1.125|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-10 h).|||1.125|0.912|
74078280|NCT01929863|147710555|SUPERIORITY_OR_OTHER||Ratio|1.036|||||TWO_SIDED|90.0|0.937|1.145|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Cmax.|||1.145|0.937|
74078281|NCT02911701|147710557|SUPERIORITY|||||||0.3|||||||maxim|||||||0.3
74078282|NCT00830024|147710576|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|98.75||||||90.0|93.35|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.47|93.35|
74078283|NCT00830024|147710577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.94||||||90.0|91.76|100.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.3|91.76|
74078284|NCT00830024|147710578|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.89||||||90.0|91.67|100.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.31|91.67|
74078285|NCT00950989|147710619|SUPERIORITY||Difference in response rate|3.2||||0.598|TWO_SIDED|95.0|-9.0|15.4||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||15.4|-9.0|0.598
74078286|NCT00950989|147710619|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
74078287|NCT00950989|147710619|SUPERIORITY||Difference in response rate|3.2||||0.635|TWO_SIDED|95.0|-9.0|15.4||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||15.4|-9.0|0.635
74078288|NCT00950989|147710619|SUPERIORITY|||||||0.74||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.740
74078289|NCT00950989|147710619|SUPERIORITY||Difference in response rate|-3.2||||0.572|TWO_SIDED|95.0|-14.1|7.8||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||7.8|-14.1|0.572
74078290|NCT00950989|147710619|SUPERIORITY|||||||0.572||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.572
74078291|NCT00950989|147710620|SUPERIORITY||Difference in response rates|-3.2||||0.728|TWO_SIDED|95.0|-20.4|14.0||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||14.0|-20.4|0.728
74078292|NCT00950989|147710620|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
74078293|NCT00950989|147710620|SUPERIORITY||Difference in response rates|-6.3||||0.412|TWO_SIDED|95.0|-23.4|10.7||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||10.7|-23.4|0.412
74078294|NCT00950989|147710620|SUPERIORITY|||||||0.74||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedures|||||||0.740
74078295|NCT00950989|147710620|SUPERIORITY||Difference in response rates|3.2||||0.74|TWO_SIDED|95.0|-14.2|20.5||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||20.5|-14.2|0.740
74078296|NCT00950989|147710620|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
74078297|NCT00950989|147710621|SUPERIORITY||Difference in response rates|0.0||||0.984|TWO_SIDED|95.0|-6.1|6.1||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||6.1|-6.1|0.984
74078298|NCT00950989|147710621|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
74078299|NCT00950989|147710621|SUPERIORITY||Difference in response rates|0.0||||0.993|TWO_SIDED|95.0|-6.1|6.1||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||6.1|-6.1|0.993
74078300|NCT00950989|147710621|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
74078301|NCT00950989|147710621|SUPERIORITY||Difference in response rates|-3.2||||0.159|TWO_SIDED|95.0|-7.5|1.2||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||1.2|-7.5|0.159
74078302|NCT00950989|147710621|SUPERIORITY|||||||0.797||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.797
74078303|NCT00950989|147710622|SUPERIORITY||LS Mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.459|TWO_SIDED|95.0|-0.7|0.3||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.3|-0.7|0.459
74078304|NCT00950989|147710622|SUPERIORITY||LS mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.906|TWO_SIDED|95.0|-0.5|0.5||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.5|-0.5|0.906
74078305|NCT00950989|147710622|SUPERIORITY||LS mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.849|TWO_SIDED|95.0|-0.5|0.5||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.5|-0.5|0.849
74078306|NCT03804983|147710642|OTHER|Analysis of Variance||||||0.178||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.178
74078307|NCT03804983|147710643|OTHER|Analysis of Variance||||||0.145||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.145
74078308|NCT03804983|147710644|OTHER|Analysis of Variance||||||0.304||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.304
74078309|NCT03804983|147710645|OTHER|Analysis of Variance||||||0.131||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.131
74078310|NCT03804983|147710647|OTHER|Analysis of Variance||||||0.206||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.206
74078311|NCT03804983|147710648|OTHER|Analysis of Variance||||||0.335||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.335
74078312|NCT03804983|147710649|OTHER|Analysis of Variance||||||0.637||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.637
74078313|NCT03804983|147710650|OTHER|Analysis of Variance||||||0.347||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.347
74078314|NCT03804983|147710651|OTHER|Analysis of Variance||||||0.057||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.057
74078315|NCT03804983|147710652|OTHER|Analysis of Variance||||||0.435||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.435
74078316|NCT03804983|147710653|OTHER|Analysis of Variance||||||0.135||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.135
74078317|NCT03804983|147710654|OTHER|Analysis of Variance||||||0.271||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.271
73886096|NCT01709721|147305842|SUPERIORITY|||||||0.016|||||||ANCOVA|ANCOVA, with randomization group as the factor and initial parameter value as covariate.||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0160
74078318|NCT03804983|147710655|OTHER|Analysis of Variance||||||1||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||1.0
74078319|NCT03804983|147710657|OTHER|Analysis of Variance||||||1||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||1.0
74078320|NCT03804983|147710658|OTHER|Analysis of Variance||||||0.294||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.294
74078321|NCT03804983|147710659|OTHER|Analysis of Variance||||||0.584||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.584
74078322|NCT03804983|147710660|OTHER|Analysis of Variance||||||0.69||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.69
74078323|NCT03804983|147710661|OTHER|Analysis of Variance||||||0.066||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.066
74078324|NCT03804983|147710662|OTHER|Analysis of Variance||||||0.904||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.904
74078325|NCT00424047|147710676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.324|||<|0.001|TWO_SIDED|95.0|0.24|0.438|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dex:Placebo/Dexamethasone)|||0.438|0.240|<0.001
74078326|NCT00424047|147710677|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.105|TWO_SIDED|95.0|0.498|1.07|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dexamethasone:Placebo/Dexamethasone)|||1.070|0.498|0.105
74078327|NCT00424047|147710678|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.302|TWO_SIDED|95.0|0.651|1.143|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||1.143|0.651|0.302
74078328|NCT00424047|147710679|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test||||||<0.001
74078329|NCT00424047|147710680|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test||||||<0.001
74078330|NCT00424047|147710683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.558||||0.021|TWO_SIDED|95.0|0.338|0.921|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone : placebo/dexamethasone).|||0.921|0.338|0.021
74078331|NCT00424047|147710684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.362|||<|0.001|TWO_SIDED|95.0|0.27|0.478||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||0.478|0.27|<0.001
74078332|NCT00424047|147710685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.166||||0.271|TWO_SIDED|95.0|0.887|1.532||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone: placebo/dexamethasone)|||1.532|0.887|0.271
74078333|NCT00424047|147710686|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.135||||0.359|TWO_SIDED|95.0|0.866|1.486||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||1.486|0.866|0.359
74078334|NCT00424047|147710687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.619||||0.032|TWO_SIDED|95.0|0.398|0.964|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||0.964|0.398|0.032
74078335|NCT02571907|147710689|OTHER||||||||||||||||||A Bayesian beta-binomial model with a Uniform(0, 1) prior was used to compute a 95% credible interval for the proportion of patients meeting the primary endpoint. The lower bound of this credible interval (2.5th percentile of the posterior distribution) was 91.2%, which was greater than the performance goal of 55%.|||
74078336|NCT02571907|147710690|OTHER||||||||||||||||||A Bayesian beta-binomial model with a Uniform(0, 1) prior was used to compute a 95% credible interval for the proportion of patients meeting the secondary endpoint. The lower bound of this credible interval (2.5th percentile of the posterior distribution) was 70.8%, which was greater than the performance goal of 46%.|||
74078337|NCT03666026|147710691|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.03||||||||1.03|1.00|
74078338|NCT03666026|147710691|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04||||||||1.04|1.00|
74078339|NCT03666026|147710691|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04||||||||1.04|1.00|
74078340|NCT00834717|147710696|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.86||||||90.0|92.36|103.69|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.69|92.36|
73886097|NCT01709721|147305843|SUPERIORITY|||||||0.0007|||||||ANCOVA|ANCOVA, with randomization group as the factor and initial parameter value as covariate.||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0007
74078341|NCT00834717|147710697|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.57||||||90.0|82.8|103.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.48|82.80|
74078342|NCT00834717|147710698|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.95||||||90.0|83.11|103.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.97|83.11|
74078343|NCT00238615|147710716|SUPERIORITY_OR_OTHER||probability of survival at 2 years|0.72|STANDARD_DEVIATION|0.0|||TWO_SIDED|95.0|0.36|0.9||The primary endpoint of 2 year overall survival was (0.72) = 72%||||2-year overall survival (OS) Our null hypothesis was a probability of survival at 2 years of 0.30. The study was powered at 80% (with α 5% two-tailed) to detect a probability of survival at 2 years of 0.55. This would require 30 patients assuming accrual over 2 years with 1 year of additional follow-up. The probability of survival at 2 years of 0.55 is based on previous studies of neoadjuvant approaches with reported 2 year survival in the 40-60% range.||0.90|0.36|
74078344|NCT05710718|147710717|SUPERIORITY|||||||0.076|||||||paired T-test|No formal hypothesis test was planned for this pilot study. P-values are provided for exploratory purposes and are unadjusted for multiplicity.||||||0.076
74078345|NCT02545283|147710766|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5752|TWO_SIDED|95.0|0.81|1.45|||Log Rank|||||1.45|0.81|0.5752
74078346|NCT02826694|147710805|OTHER|||||||0.168|||||||linear mixed effect model|||T3||||0.168
74078347|NCT02826694|147710805|OTHER|||||||0.026|||||||linear mixed effect model|||T4||||0.026
74078348|NCT03264092|147710817|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.18|||||||Fisher Exact|||||||0.18
74078349|NCT03264092|147710818|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.41|||||||Fisher Exact|||||||0.41
74078350|NCT03264092|147710819|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.45|||||||Fisher Exact|||||||0.45
74078351|NCT02663349|147710829|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|df = 14||Within sample analysis of change between baseline and 3 month assessment.||||.08
74078352|NCT02663349|147710830|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||Within sample change between baseline and 6 month assessment.||||.69
74078353|NCT02663349|147710831|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|df=14||Within sample change assessed between baseline and 3-month assessment||||.02
74078354|NCT02663349|147710832|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|df = 14||Change between baseline and 6 month assessment||||.34
74078355|NCT02663349|147710833|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of change between baseline and 3-month assessment on the AIHQ Hostility scale||||>.05
74078356|NCT02663349|147710833|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Completer analysis to examine within group change between baseline and 3-month assessment on the AIHQ Aggression scale||||.04
74078357|NCT02663349|147710834|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of within group change on the AIHQ Hostility scale between baseline and the 6-month assessment||||>.05
74078358|NCT02663349|147710834|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of within group change on the AIHQ Aggression scale between baseline and the 6 month assessment||||> .05
74078359|NCT02663349|147710835|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Change within group between baseline and 3 month assessment on the TASIT total score for part 3||||> .05
74078360|NCT02663349|147710836|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||within group change on the TASIT total score for Part 3 between baseline and the 6 month assessment||||> .05
74078361|NCT02663349|147710837|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 14||Within group change on SSPA Total Score between baseline and 3-month assessment||||>.05
74078362|NCT02663349|147710838|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 14||Within group change on the SSPA total score between baseline and 6 month assessment||||> .05
74078363|NCT02663349|147710839|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Within group change on the First Episode Social Functioning Scale Performance Total score on scales 1-7 between baseline and 3-month follow-up||||> .05
74078364|NCT02663349|147710840|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Within group change between baseline and 6-month assessment on the First Episode Social Functioning Scale Performance total score on scales 1-7||||> .05
74078365|NCT02663349|147710841|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Collegial Support scale between Baseline and 3-Month assessments||||.15
74078366|NCT02663349|147710841|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Task Support scale between baseline and 3-month assessments||||.10
74078367|NCT02663349|147710841|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Mentor scale between baseline and the 3-month assessment||||>.05
74078368|NCT02663349|147710841|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Coach scale between baseline and the 3 month assessment||||> .05
74078369|NCT02663349|147710842|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Collegial Support scale between baseline and the 6-month assessment||||.01
74078370|NCT02663349|147710842|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Task Support scale between baseline and 6-month assessment||||.03
74078371|NCT02663349|147710842|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Mentor scale between baseline and the 6-month assessment||||> .05
74078372|NCT02663349|147710842|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Coach scale between baseline and the 6-month assessment||||> .05
74078373|NCT02663349|147710843|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|df = 13||Within group change on the VETSS Self Disclosure scale between Baseline and 3-Month Assessment||||.09
74078374|NCT02663349|147710843|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|df = 13||Within group change on the VETSS Workplace Coping scale between Baseline and 3-Month Assessment||||.12
74078375|NCT02663349|147710844|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on VETSS Self Disclosure scale between Baseline and 6 month assessment||||> .05
74078376|NCT02663349|147710844|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on VETSS Workplace Coping scale between baseline and the 6 month assessment||||> .05
74078377|NCT00075478|147710866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.09|TWO_SIDED|95.0|0.3|1.1|||Regression, Cox|||Reference arm is Arm 2.||1.1|0.3|.09
74078378|NCT00075478|147710867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.59|TWO_SIDED|95.0|0.1|3.0|||Regression, Cox|||||3.0|0.1|0.59
74078379|NCT00075478|147710868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.06|TWO_SIDED|95.0|0.3|1.0|||Regression, Cox|||||1.0|0.3|0.06
74078380|NCT00075478|147710869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.09|TWO_SIDED|95.0|0.3|1.1|||Regression, Cox|||||1.1|0.3|0.09
74078381|NCT00075478|147710870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.16|TWO_SIDED|95.0|0.8|3.1|||Regression, Cox|||||3.1|0.8|0.16
74078382|NCT00075478|147710871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.52||||0.14|TWO_SIDED|95.0|0.9|2.7|||Regression, Cox|||||2.7|0.9|0.14
74078383|NCT00075478|147710873|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.05|TWO_SIDED|95.0|0.3|1.0|||Regression, Cox|||||1.0|0.3|0.05
74078384|NCT00673660|147710875|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Total cholesterol||||<0.001
74078385|NCT00673660|147710875|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||LDL cholesterol||||<0.001
74078386|NCT00673660|147710875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.972|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 1 sided|||HDL cholesterol||||0.972
74078387|NCT00673660|147710875|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Triglycerides||||0.034
74078388|NCT05099380|147710879|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|95.0|-0.6|6.7|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculation using a two independent sample t test with a 2-sided type I error of 0.05, there would be enough power (i.e., 80%) for testing non-inferiority of the Test relative to the Control with 286 subjects (143 for each lens group) competing the study assuming the Test was 2 points higher than the Control.||6.7|-0.6|
74078389|NCT05099380|147710880|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the 2-sided 95% confidence interval of the mean difference was below 0.05.|Least-square Mean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.008|||TWO_SIDED|95.0|-0.02|0.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculation using a linear mixed model-based method with a 2-sided type I error of 0.05, there would be enough power (i.e., at least 80%) for testing non-inferiority of the Test relative to the Control with 16 subjects (8 for each lens group) competing the study assuming no difference between the Test and the Control.||0.01|-0.02|
74078390|NCT05099380|147710881|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the 95% central posterior credible interval of proportion difference was below 0.05.|Mean Proportion Difference|0.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|-0.004|0.004|||Bayesian hierarchical model||Proportion difference was calculated as Test minus Control|Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 240 subjects (120 for each lens group) competing the study assuming no difference between the Test and the Control.||0.004|-0.004|
74078391|NCT05099380|147710882|NON_INFERIORITY|Non- inferiority was declared if the upper bound of the 95% central posterior credible interval of proportion difference was below 0.1.|Mean Proportion Difference|0.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|-0.004|0.004|||Bayesian hierarchical model||Proportion difference was calculated as Test minus Control|Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 140 subjects (70 for each lens group) competing the study assuming no difference between the Test and the Control.||0.004|-0.004|
74078392|NCT05099380|147710883|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|-4.8|4.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 73% for CLUE comfort using a two independent sample t test with a 2-sided type I error of 0.05.||4.5|-4.8|
74078393|NCT05099380|147710884|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-6.0|2.3|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points lower than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 23% for CLUE handling using a two independent sample t test with a 2-sided type I error of 0.05.||2.3|-6.0|
74078394|NCT05099380|147710885|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the odds ratio was greater than 0.67.|Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.83|2.16|||Linear Mixed Model||Odds Ratio was calculated as Test over Control|"Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of Excellent rating for the Test was 10% higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 93% using a Pearson chi-square test for two proportions with a 2-sided type I error of 0.05."||2.16|0.83|
74078395|NCT05099380|147710886|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval of the preference ratio was greater than 1.|Preference Ratio|2.4|||||TWO_SIDED|95.0|1.4|4.1|||Linear Mixed Model||Preference ratio was calculated as Study lens over Habitual lens within the Test lens group.|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of subjects preferring Study lens was 20% higher than preferring Habitual lens in the Test lens group, the estimated statistical power for testing superiority of the Test relative to the Habitual was 88% using a simulation approach with a 2-sided type I error of 0.05.||4.10|1.40|
74078396|NCT01020474|147710887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.121|TWO_SIDED|95.0|-1.51|0.18||Missing data for week 15 mean pain score are imputed based on distribution of baseline pain scores if participants discontinue due to adverse events/ abnormal laboratory test results or lack of efficacy.|ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||0.18|-1.51|0.121
74078397|NCT01020474|147710888|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18||||0.655|TWO_SIDED|95.0|-1.0|0.63|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||0.63|-1.00|0.655
74078398|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07||||0.842|TWO_SIDED|95.0|-0.75|0.61|||Mixed Models Analysis|||Statistical analysis of Week 1.||0.61|-0.75|0.842
74078399|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.07|TWO_SIDED|95.0|-1.32|0.05|||Mixed Models Analysis|||Statistical analysis of Week 2||0.05|-1.32|0.070
74078400|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83||||0.019|TWO_SIDED|95.0|-1.51|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 3.||-0.14|-1.51|0.019
73886098|NCT01709721|147305844|SUPERIORITY|||||||0.0088||||||ANCOVA, with randomization group as the factor and initial parameter value as covariate.|ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0088
73886099|NCT01709721|147305845|SUPERIORITY|||||||0.011||||||Log-rank test for Kaplan-Meier Estimate of Time to Rescue (days).|Log Rank|||||||0.011
74078401|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.011|TWO_SIDED|95.0|-1.59|-0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.||-0.21|-1.59|0.011
74078402|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68||||0.056|TWO_SIDED|95.0|-1.38|0.02|||Mixed Models Analysis|||Statistical analysis of Week 5.||0.02|-1.38|0.056
74078403|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96||||0.008|TWO_SIDED|95.0|-1.66|-0.26|||Mixed Models Analysis|||Statistical analysis of Week 6.||-0.26|-1.66|0.008
74078404|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.89||||0.013|TWO_SIDED|95.0|-1.6|-0.19|||Mixed Models Analysis|||Statistical analysis of Week 7.||-0.19|-1.60|0.013
74078405|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.06||||0.004|TWO_SIDED|95.0|-1.77|-0.35|||Mixed Models Analysis|||Statistical analysis of Week 8.||-0.35|-1.77|0.004
74078406|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.95||||0.009|TWO_SIDED|95.0|-1.67|-0.24|||Mixed Models Analysis|||Statistical analysis of Week 9.||-0.24|-1.67|0.009
74078407|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97||||0.008|TWO_SIDED|95.0|-1.69|-0.25|||Mixed Models Analysis|||Statistical analysis of Week 10.||-0.25|-1.69|0.008
73886100|NCT01709721|147305846|SUPERIORITY|||||||0.0335|||||||Cochran-Mantel-Haenszel|||P-value by the Cochran-Mantel-Haenszel mean score test (using equally spaced scores).||||0.0335
74078408|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.021|TWO_SIDED|95.0|-1.59|-0.13|||Mixed Models Analysis|||Statistical analysis of Week 11.||-0.13|-1.59|0.021
74078409|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97||||0.01|TWO_SIDED|95.0|-1.71|-0.23|||Mixed Models Analysis|||Statistical analysis of Week 12.||-0.23|-1.71|0.010
74078410|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.051|TWO_SIDED|95.0|-1.49|0.0|||Mixed Models Analysis|||Statistical analysis of Week 13.||0.00|-1.49|0.051
73886101|NCT01709721|147305848|SUPERIORITY|Pearson's chi-square test||||||0.01||||||Pearson's chi-square test|Chi-squared|||||||0.010
73886102|NCT02121158|147305852|EQUIVALENCE|Unadjusted|Hazard Ratio (HR)|0.915||||0.7457|TWO_SIDED|95.0|0.534|1.568|||Cox Proportional Hazards|||||1.568|0.534|0.7457
73886103|NCT02435992|147305895|SUPERIORITY||Odds Ratio (OR)|3.586||||0.0001|TWO_SIDED|95.0|1.938|6.636|||Cochran-Mantel-Haenszel|||||6.636|1.938|0.0001
73886104|NCT02435992|147305896|SUPERIORITY||Odds Ratio (OR)|2.755||||0.0001|TWO_SIDED|95.0|1.767|4.294|||Cochran-Mantel-Haenszel|||||4.294|1.767|0.0001
74078411|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.02|TWO_SIDED|95.0|-1.66|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 14.||-0.14|-1.66|0.020
74078412|NCT01020474|147710889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.06|TWO_SIDED|95.0|-1.51|0.03|||Mixed Models Analysis|||Statistical analysis of Week 15.||0.03|-1.51|0.060
74078413|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.54|TWO_SIDED|95.0|-0.9|0.47|||Mixed Models Analysis|||Statistical analysis of Week 1.||0.47|-0.90|0.540
74078414|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19||||0.593|TWO_SIDED|95.0|-0.87|0.5|||Mixed Models Analysis|||Statistical analysis of Week 2||0.50|-0.87|0.593
74078415|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.206|TWO_SIDED|95.0|-1.13|0.25|||Mixed Models Analysis|||Statistical analysis of Week 3.||0.25|-1.13|0.206
74078416|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49||||0.168|TWO_SIDED|95.0|-1.18|0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.||0.21|-1.18|0.168
74078417|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38||||0.28|TWO_SIDED|95.0|-1.08|0.32|||Mixed Models Analysis|||Statistical analysis of Week 5.||0.32|-1.08|0.280
74078418|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.075|TWO_SIDED|95.0|-1.34|0.06|||Mixed Models Analysis|||Statistical analysis of Week 6.||0.06|-1.34|0.075
74078419|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.168|TWO_SIDED|95.0|-1.21|0.21|||Mixed Models Analysis|||Statistical analysis of Week 7.||0.21|-1.21|0.168
74078420|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01||||0.006|TWO_SIDED|95.0|-1.73|-0.3|||Mixed Models Analysis|||Statistical analysis of Week 8.||-0.30|-1.73|0.006
74078421|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.57||||0.12|TWO_SIDED|95.0|-1.29|0.15|||Mixed Models Analysis|||Statistical analysis of Week 9.||0.15|-1.29|0.120
74078422|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.037|TWO_SIDED|95.0|-1.49|-0.05|||Mixed Models Analysis|||Statistical analysis of Week 10.||-0.05|-1.49|0.037
74078423|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.246|TWO_SIDED|95.0|-1.16|0.3|||Mixed Models Analysis|||Statistical analysis of Week 11.||0.30|-1.16|0.246
74078424|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.105|TWO_SIDED|95.0|-1.36|0.13|||Mixed Models Analysis|||Statistical analysis of Week 12.||0.13|-1.36|0.105
74078425|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||0.376|TWO_SIDED|95.0|-1.09|0.41|||Mixed Models Analysis|||Statistical analysis of Week 13.||0.41|-1.09|0.376
74078426|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.285|TWO_SIDED|95.0|-1.18|0.35|||Mixed Models Analysis|||Statistical analysis of Week 14.||0.35|-1.18|0.285
74078427|NCT01020474|147710890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17||||0.663|TWO_SIDED|95.0|-0.95|0.61|||Mixed Models Analysis|||Statistical analysis of Week 15.||0.61|-0.95|0.663
74078428|NCT01020474|147710891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87||||0.037|TWO_SIDED|95.0|-1.68|-0.05|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||-0.05|-1.68|0.037
74078429|NCT01020474|147710892|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.694|TWO_SIDED|95.0|0.53|2.58|||Regression, Logistic|||Statistical analysis at Week 15.||2.58|0.53|0.694
74078430|NCT01020474|147710893|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.162|TWO_SIDED|95.0|0.72|7.02|||Regression, Logistic|||Statistical analysis at Week 15.||7.02|0.72|0.162
74078431|NCT01020474|147710894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Cochran-Mantel-Haenszel|P-value uses the row mean score statistic based on Cochran Mantel Haenszel (CMH) test with modified ridit transformation.||Statistical analysis at Week 15.||||0.013
74078432|NCT00466167|147710895|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|4.9|STANDARD_ERROR_OF_MEAN|1.3||0.0001|TWO_SIDED|95.0|2.4|7.4|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||7.4|2.4|0.0001
74078433|NCT00466167|147710895|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|6.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|4.2|9.1|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||9.1|4.2|<.0001
74078434|NCT00466167|147710896|SUPERIORITY_OR_OTHER||Adjusted mean difference from Placebo|4.5|STANDARD_ERROR_OF_MEAN|1.8||0.0122|TWO_SIDED|95.0|1.0|7.9|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||7.9|1.0|0.0122
74078435|NCT00466167|147710896|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|7.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|3.7|10.5|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||10.5|3.7|<.0001
74078436|NCT02825680|147710922|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||This analysis compares reach within the pre-intervention timeframe versus the post-intervention timeframe for each LEAP (intervention) and control case. Intention to treat analysis was used; all participating facilities randomized to the LEAP (intervention) arm were included whether or not they completed the intervention.||||.011
74078437|NCT03100344|147711005|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-13.6||||0.051|TWO_SIDED|95.0|-27.3|0.0|||Kenward-Rogers|||||0.0|-27.3|0.051
74078438|NCT03100344|147711005|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-16.7||||0.016|TWO_SIDED|95.0|-30.2|-3.2|||Kenward Roger|||||-3.2|-30.2|0.016
74078439|NCT03100344|147711005|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-6.8||||0.322|TWO_SIDED|95.0|-20.5|6.8|||Kenward Roger|||||6.8|-20.5|0.322
74078440|NCT03100344|147711006|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.034|TWO_SIDED|95.0|2.0|35.8|||Cochran-Mantel-Haenszel|||||35.8|2.0|0.034
74078441|NCT03100344|147711006|SUPERIORITY||Mean Difference (Final Values)|31.4|||<|0.001|TWO_SIDED|95.0|14.7|48.2|||Cochran-Mantel-Haenszel|||||48.2|14.7|<0.001
74078442|NCT03100344|147711006|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.154|TWO_SIDED|95.0|-4.2|28.6|||Cochran-Mantel-Haenszel|||||28.6|-4.2|0.154
74078443|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|10.9||||0.062|TWO_SIDED|95.0|-0.4|22.2|||Cochran-Mantel-Haenszel|||Week 1||22.2|-0.4|0.062
74078444|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.042|TWO_SIDED|95.0|0.8|23.6|||Cochran-Mantel-Haenszel|||Week 1||23.6|0.8|0.042
74078445|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.307|TWO_SIDED|95.0|-4.7|15.0|||Cochran-Mantel-Haenszel|||Week 1||15.0|-4.7|0.307
74078446|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|24.0||||0.003|TWO_SIDED|95.0|9.3|38.7|||Cochran-Mantel-Haenszel|||Week 2||38.7|9.3|0.003
74078447|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|26.2||||0.001|TWO_SIDED|95.0|11.4|40.9|||Cochran-Mantel-Haenszel|||Week 2||40.9|11.4|0.001
74078448|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.011|TWO_SIDED|95.0|4.9|33.1|||Cochran-Mantel-Haenszel|||Week 2||33.1|4.9|0.011
74078449|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|27.6|||<|0.001|TWO_SIDED|95.0|13.5|41.7|||Cochran-Mantel-Haenszel|||Week 4||41.7|13.5|<0.001
74078450|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|40.3|||<|0.001|TWO_SIDED|95.0|25.7|54.8|||Cochran-Mantel-Haenszel|||Week 4||54.8|25.7|<0.001
74078451|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|31.6|||<|0.001|TWO_SIDED|95.0|17.4|45.8|||Cochran-Mantel-Haenszel|||Week 4||45.8|17.4|<0.001
74078452|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.018|TWO_SIDED|95.0|4.2|37.1|||Cochran-Mantel-Haenszel|||Week 8||37.1|4.2|0.018
74078453|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|43.7|||<|1|TWO_SIDED|95.0|27.6|59.9|||Cochran-Mantel-Haenszel|||Week 8||59.9|27.6|<0001
74078454|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|26.1||||0.003|TWO_SIDED|95.0|9.7|42.6|||Cochran-Mantel-Haenszel|||Week 8||42.6|9.7|0.003
74078455|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|24.4||||0.007|TWO_SIDED|95.0|7.3|41.4|||Cochran-Mantel-Haenszel|||Week 12||41.4|7.3|0.007
74078456|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|43.6|||<|0.001|TWO_SIDED|95.0|27.4|59.9|||Cochran-Mantel-Haenszel|||Week 12||59.9|27.4|<0.001
74078457|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.03|TWO_SIDED|95.0|2.4|35.9|||Cochran-Mantel-Haenszel|||Week 12||35.9|2.4|0.030
73886105|NCT01761877|147305907|OTHER|Mixed Models Analysis|||||<|0.05||||||A p value was calculated for change in breast density from baseline to 12 months separately for each study arm.|Mixed Models Analysis|||The study was designed to assess change in breast density using fat/water MRI after 12 months of sulindac intervention in postmenopausal breast cancer patients taking aromatase inhibitors for the treatment of estrogen receptor positive breast cancer. A non-randomized observation arm was included with the same eligibility criteria to assess change in breast density over 12 months using the fat/water MRI method of quantifying breast density. Change was examined separately for each arm.||||<0.05
73886106|NCT01761877|147305908|OTHER||||||<|0.05||||||A p value of \<0.05 was selected for change in each arm. The study did not include a direct comparison between the two arms.|Mixed Models Analysis|||||||<0.05
74078458|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|33.3|||<|0.001|TWO_SIDED|95.0|16.4|50.2|||Cochran-Mantel-Haenszel|||Week 16||50.2|16.4|<0.001
74078459|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|47.2|||<|0.001|TWO_SIDED|95.0|31.2|63.2|||Cochran-Mantel-Haenszel|||Week 16||63.2|31.2|<0.001
74078460|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|22.8||||0.01|TWO_SIDED|95.0|6.1|39.4|||Cochran-Mantel-Haenszel|||Week 16||39.4|6.1|0.010
74078461|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|26.3||||0.004|TWO_SIDED|95.0|9.2|43.5|||Cochran-Mantel-Haenszel|||Week 20||43.5|9.2|0.004
74078462|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|36.7|||<|0.001|TWO_SIDED|95.0|20.1|53.3|||Cochran-Mantel-Haenszel|||Week 20||53.3|20.1|<0.001
74078463|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|24.5||||0.007|TWO_SIDED|95.0|7.6|41.4|||Cochran-Mantel-Haenszel|||Week 20||41.4|7.6|0.007
74078464|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.022|TWO_SIDED|95.0|3.6|38.1|||Cochran-Mantel-Haenszel|||Week 24||38.1|3.6|0.022
74078465|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|24.3||||0.007|TWO_SIDED|95.0|7.4|41.3|||Cochran-Mantel-Haenszel|||Week 24||41.3|7.4|0.007
74078466|NCT03100344|147711007|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.05|TWO_SIDED|95.0|0.4|34.4|||Cochran-Mantel-Haenszel|||Week 24||34.4|0.4|0.050
73886107|NCT01761877|147305909|OTHER||||||<|0.05|TWO_SIDED|95.0||||A p value of \<0.05 was selected for change in each arm. The study did not include a direct comparison between the two arms.|Mixed Models Analysis|||||||<0.05
74078467|NCT03100344|147711008|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-14.4||||0.017|TWO_SIDED|95.0|-26.2|-2.7|||Kenward Roger|||||-2.7|-26.2|0.017
74078468|NCT03100344|147711008|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-11.3||||0.058|TWO_SIDED|95.0|-23.1|0.4|||Kenward Roger|||||0.4|-23.1|0.058
74078469|NCT03100344|147711008|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-20.0|||<|0.001|TWO_SIDED|95.0|-31.6|-8.3|||Kenward Roger|||||-8.3|-31.6|<0.001
74078470|NCT03100344|147711009|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-9.6||||0.016|TWO_SIDED|95.0|-17.5|-1.8|||Kenward Roger|||||-1.8|-17.5|0.016
74078471|NCT03100344|147711009|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-12.8||||0.001|TWO_SIDED|95.0|-20.6|-5.1|||Kenward Roger|||||-5.1|-20.6|0.001
74078472|NCT03100344|147711009|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-7.6||||0.058|TWO_SIDED|95.0|-15.4|0.3|||Kenward Roger|||||0.3|-15.4|0.058
74078473|NCT03100344|147711010|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-24.5|||<|0.001|TWO_SIDED|95.0|-37.8|-11.2|||Kenward Roger|||||-11.2|-37.8|<0.001
74078474|NCT03100344|147711010|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-31.7|||<|0.001|TWO_SIDED|95.0|-44.9|-18.6|||Kenward Roger|||||-18.6|-44.9|<0.001
74078475|NCT03100344|147711010|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-25.1|||<|0.001|TWO_SIDED|95.0|-38.4|-11.8|||Kenward Roger|||||-11.8|-38.4|<0.001
74078476|NCT03100344|147711011|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-2.0|||<|0.001|TWO_SIDED|95.0|-3.1|-1.0|||Kenward Roger|||||-1.0|-3.1|<0.001
74078477|NCT03100344|147711011|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-2.3|||<|0.001|TWO_SIDED|95.0|-3.4|-1.3|||Kenward Roger|||||-1.3|-3.4|<0.001
74078478|NCT03100344|147711011|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-1.9|||<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||Kenward Roger|||||-0.9|-3.0|<0.001
74078479|NCT03100344|147711012|OTHER||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||At week 1||5.1|-4.9|0.970
74078480|NCT03100344|147711012|OTHER||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||At week 1||7.5|-4.1|0.574
74078481|NCT03100344|147711012|OTHER||Mean Difference (Final Values)|-1.8||||0.311|TWO_SIDED|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||At week 1||1.7|-5.2|0.311
74078482|NCT03100344|147711012|OTHER||Mean Difference (Final Values)|4.2||||0.598|TWO_SIDED|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||At week 24||19.8|-11.3|0.598
74078483|NCT03100344|147711012|OTHER||Mean Difference (Final Values)|15.5||||0.066|TWO_SIDED|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||At week 24||31.4|-0.4|0.066
74078484|NCT03100344|147711012|OTHER||Mean Difference (Final Values)|1.7||||0.826|TWO_SIDED|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||At week 24||16.9|-13.5|0.826
74078485|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.558|TWO_SIDED|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2||4.1|-7.7|0.558
74078486|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2||11.6|-4.7|0.413
74078487|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.543|TWO_SIDED|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.0|-7.7|0.543
74078488|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.583|TWO_SIDED|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4||4.2|-7.6|0.583
74078489|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.028|TWO_SIDED|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4||22.5|1.8|0.028
74078490|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.087|TWO_SIDED|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4||18.3|-0.9|0.087
74078491|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.632|TWO_SIDED|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8||9.4|-5.6|0.632
74078492|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.016|TWO_SIDED|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8||24.8|3.1|0.016
74078493|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|15.8||||0.009|TWO_SIDED|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8||27.0|4.5|0.009
74078494|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.974|TWO_SIDED|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12||11.6|-11.2|0.974
74078495|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.031|TWO_SIDED|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12||29.3|1.8|0.031
74078496|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.032|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 12||28.2|-0.3|0.032
74078497|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.553|TWO_SIDED|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16||16.9|-9.0|0.553
74078498|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.008|TWO_SIDED|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16||35.8|6.1|0.008
74078499|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.061|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16||28.2|-0.3|0.061
74078500|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.585|TWO_SIDED|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20||18.0|-10.1|0.585
74078501|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.032|TWO_SIDED|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20||32.8|2.0|0.032
74078502|NCT03100344|147711012|SUPERIORITY||Mean Difference (Final Values)|8.6||||0.254|TWO_SIDED|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20||23.1|-5.9|0.254
74078503|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.487|TWO_SIDED|95.0|-6.8|14.3|||Cochran-Mantel-Haenszel|||Week 1||14.3|-6.8|0.487
74078504|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.033|TWO_SIDED|95.0|1.6|26.5|||Cochran-Mantel-Haenszel|||Week 1||26.5|1.6|0.033
74078505|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.053|TWO_SIDED|95.0|0.2|23.8|||Cochran-Mantel-Haenszel|||Week 1||23.8|0.2|0.053
74078506|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|18.5||||0.021|TWO_SIDED|95.0|3.2|33.8|||Cochran-Mantel-Haenszel|||Week 2||33.8|3.2|0.021
74078507|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.027|TWO_SIDED|95.0|2.4|32.3|||Cochran-Mantel-Haenszel|||Week 2||32.3|2.4|0.027
74078508|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|22.7||||0.006|TWO_SIDED|95.0|7.3|38.1|||Cochran-Mantel-Haenszel|||Week 2||38.1|7.3|0.006
74078509|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.086|TWO_SIDED|95.0|-1.7|32.2|||Cochran-Mantel-Haenszel|||Week 4||32.2|-1.7|0.086
74078510|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|26.2||||0.004|TWO_SIDED|95.0|9.3|43.1|||Cochran-Mantel-Haenszel|||Week 4||43.1|9.3|0.004
74078511|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.05|TWO_SIDED|95.0|0.5|34.2|||Cochran-Mantel-Haenszel|||Week 4||34.2|0.5|0.050
74078512|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|20.7||||0.023|TWO_SIDED|95.0|3.3|38.1|||Cochran-Mantel-Haenszel|||Week 8||38.1|3.3|0.023
73886108|NCT03165617|147305929|SUPERIORITY|Success criterion were met as the LL of the 2-sided 95% CI was above 20%.|Absolute Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical Analysis title - Absolute Vaccine Efficacy Any Strain. Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 20% (primary endpoint) using the protocol definition of ILI for the entire age range (2 to \<18 years of age).||62.12|45.67|
74078513|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.002|TWO_SIDED|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8||45.0|10.7|0.002
74078514|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.002|TWO_SIDED|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8||45.0|10.7|0.002
74078515|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|19.3||||0.041|TWO_SIDED|95.0|1.3|37.3|||Cochran-Mantel-Haenszel|||Week 12||37.3|1.3|0.041
74078516|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.003|TWO_SIDED|95.0|10.4|45.4|||Cochran-Mantel-Haenszel|||Week 12||45.4|10.4|0.003
74078517|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.063|TWO_SIDED|95.0|-0.5|35.2|||Cochran-Mantel-Haenszel|||Week 12||35.2|-0.5|0.063
74078518|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|17.6||||0.064|TWO_SIDED|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 16||35.6|-0.4|0.064
74078519|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|22.6||||0.016|TWO_SIDED|95.0|4.9|40.3|||Cochran-Mantel-Haenszel|||Week 16||40.3|4.9|0.016
74078520|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.041|TWO_SIDED|95.0|1.3|36.9|||Cochran-Mantel-Haenszel|||Week 16||36.9|1.3|0.041
74078521|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|17.6||||0.064|TWO_SIDED|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 20||35.6|-0.4|0.064
74078522|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|26.0||||0.005|TWO_SIDED|95.0|8.6|43.4|||Cochran-Mantel-Haenszel|||Week 20||43.4|8.6|0.005
74078523|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|17.2||||0.064|TWO_SIDED|95.0|-0.6|35.0|||Cochran-Mantel-Haenszel|||Week 20||35.0|-0.6|0.064
74078524|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|15.9||||0.094|TWO_SIDED|95.0|-2.0|33.8|||Cochran-Mantel-Haenszel|||Week 24||33.8|-2.0|0.094
74078525|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|22.4||||0.014|TWO_SIDED|95.0|5.1|39.6|||Cochran-Mantel-Haenszel|||Week 24||39.6|5.1|0.014
74078526|NCT03100344|147711013|SUPERIORITY||Mean Difference (Final Values)|10.2||||0.273|TWO_SIDED|95.0|-7.7|28.0|||Cochran-Mantel-Haenszel|||Week 24||28.0|-7.7|0.273
74078527|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.979|TWO_SIDED|95.0|-6.8|7.0|||Cochran-Mantel-Haenszel|||Week 1||7.0|-6.8|0.979
74078528|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.668|TWO_SIDED|95.0|-5.8|9.0|||Cochran-Mantel-Haenszel|||Week 1||9.0|-5.8|0.668
74078529|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.658|TWO_SIDED|95.0|-5.8|9.2|||Cochran-Mantel-Haenszel|||Week 1||9.2|-5.8|0.658
74078530|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.69|TWO_SIDED|95.0|-8.0|12.2|||Cochran-Mantel-Haenszel|||Week 2||12.2|-8.0|0.690
74078531|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.521|TWO_SIDED|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel|||Week 2||13.7|-6.9|0.521
74078532|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.033|TWO_SIDED|95.0|1.5|26.5|||Cochran-Mantel-Haenszel|||Week 2||26.5|1.5|0.033
74078533|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.172|TWO_SIDED|95.0|-3.1|18.0|||Cochran-Mantel-Haenszel|||Week 4||18.0|-3.1|0.172
74078534|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|15.7||||0.014|TWO_SIDED|95.0|3.7|27.7|||Cochran-Mantel-Haenszel|||Week 4||27.7|3.7|0.014
74078535|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|21.0||||0.002|TWO_SIDED|95.0|8.2|33.9|||Cochran-Mantel-Haenszel|||Week 4||33.9|8.2|0.002
74078536|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.404|TWO_SIDED|95.0|-7.5|18.8|||Cochran-Mantel-Haenszel|||Week 8||18.8|-7.5|0.404
74078537|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|24.5||||0.003|TWO_SIDED|95.0|9.4|39.6|||Cochran-Mantel-Haenszel|||Week 8||39.6|9.4|0.003
74078538|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|14.1||||0.059|TWO_SIDED|95.0|-0.1|28.2|||Cochran-Mantel-Haenszel|||Week 8||28.2|-0.1|0.059
74078539|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|9.7||||0.222|TWO_SIDED|95.0|-5.6|25.0|||Cochran-Mantel-Haenszel|||Week 12||25.0|-5.6|0.222
74078540|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|26.1||||0.003|TWO_SIDED|95.0|10.0|42.3|||Cochran-Mantel-Haenszel|||Week 12||42.3|10.0|0.003
74078541|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.22|TWO_SIDED|95.0|3.3|35.0|||Cochran-Mantel-Haenszel|||Week 12||35.0|3.3|0.22
74078542|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|13.3||||0.111|TWO_SIDED|95.0|-2.8|29.3|||Cochran-Mantel-Haenszel|||Week 16||29.3|-2.8|0.111
74078543|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|29.6|||<|0.001|TWO_SIDED|95.0|13.2|46.0|||Cochran-Mantel-Haenszel|||Week 16||46.0|13.2|<0.001
74078544|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.04|TWO_SIDED|95.0|1.3|33.6|||Cochran-Mantel-Haenszel|||Week 16||33.6|1.3|0.040
74078545|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.262|TWO_SIDED|95.0|-7.3|27.4|||Cochran-Mantel-Haenszel|||Week 20||27.4|-7.3|0.262
74078546|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.327|TWO_SIDED|95.0|-8.4|25.7|||Cochran-Mantel-Haenszel|||Week 20||25.7|-8.4|0.327
74078547|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|15.7||||0.083|TWO_SIDED|95.0|-1.7|33.1|||Cochran-Mantel-Haenszel|||Week 20||33.1|-1.7|0.083
74078548|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.255|TWO_SIDED|95.0|-7.0|27.2|||Cochran-Mantel-Haenszel|||Week 24||27.2|-7.0|0.255
74078549|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.034|TWO_SIDED|95.0|2.2|35.9|||Cochran-Mantel-Haenszel|||Week 24||35.9|2.2|0.034
74078550|NCT03100344|147711014|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.053|TWO_SIDED|95.0|0.3|34.6|||Cochran-Mantel-Haenszel|||Week 24||34.6|0.3|0.053
74078551|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1||5.1|-4.9|0.970
74078552|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1||7.5|-4.1|0.574
74078553|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-4.8|4.8|||Cochran-Mantel-Haenszel|||Week 1||4.8|-4.8|0.985
74078554|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.154|TWO_SIDED|95.0|-8.4|1.2|||Cochran-Mantel-Haenszel|||Week 2||1.2|-8.4|0.154
74078555|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.978|TWO_SIDED|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2||6.6|-6.8|0.978
74078556|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.978|TWO_SIDED|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2||6.6|-6.8|0.978
74078557|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.602|TWO_SIDED|95.0|-7.5|4.3|||Cochran-Mantel-Haenszel|||Week 4||4.3|-7.5|0.602
74078558|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.5|11.4|||Cochran-Mantel-Haenszel|||Week 4||11.4|-4.5|0.413
74078559|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.658|TWO_SIDED|95.0|-5.7|9.1|||Cochran-Mantel-Haenszel|||Week 4||9.1|-5.7|0.658
74078560|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.307|TWO_SIDED|95.0|-3.2|10.3|||Cochran-Mantel-Haenszel|||Week 8||10.3|-3.2|0.307
74078561|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.002|TWO_SIDED|95.0|6.9|27.8|||Cochran-Mantel-Haenszel|||Week 8||27.8|6.9|0.002
74078562|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.054|TWO_SIDED|95.0|0.1|17.4|||Cochran-Mantel-Haenszel|||Week 8||17.4|0.1|0.054
74078563|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.325|TWO_SIDED|95.0|-5.4|16.5|||Cochran-Mantel-Haenszel|||Week 12||16.5|-5.4|0.325
74078564|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.019|TWO_SIDED|95.0|3.1|28.1|||Cochran-Mantel-Haenszel|||Week 12||28.1|3.1|0.019
74078565|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.011|TWO_SIDED|95.0|4.5|30.5|||Cochran-Mantel-Haenszel|||Week 12||30.5|4.5|0.011
74078566|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|9.2||||0.153|TWO_SIDED|95.0|-3.2|21.7|||Cochran-Mantel-Haenszel|||Week 16||21.7|-3.2|0.153
74078567|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|24.4||||0.001|TWO_SIDED|95.0|10.3|38.4|||Cochran-Mantel-Haenszel|||Week 16||38.4|10.3|0.001
74078568|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.069|TWO_SIDED|95.0|-0.7|25.1|||Cochran-Mantel-Haenszel|||Week 16||25.1|-0.7|0.069
74078569|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|12.9||||0.07|TWO_SIDED|95.0|-0.8|26.6|||Cochran-Mantel-Haenszel|||Week 20||26.6|-0.8|0.070
74078570|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.006|TWO_SIDED|95.0|6.5|35.3|||Cochran-Mantel-Haenszel|||Week 20||35.3|6.5|0.006
74078571|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.052|TWO_SIDED|95.0|0.3|27.7|||Cochran-Mantel-Haenszel|||Week 20||27.7|0.3|0.052
74078572|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|12.8||||0.069|TWO_SIDED|95.0|-0.7|26.3|||Cochran-Mantel-Haenszel|||Week 24||26.3|-0.7|0.069
74078573|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.011|TWO_SIDED|95.0|4.9|33.3|||Cochran-Mantel-Haenszel|||Week 24||33.3|4.9|0.011
74078574|NCT03100344|147711015|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.083|TWO_SIDED|95.0|-1.3|25.7|||Cochran-Mantel-Haenszel|||Week 24||25.7|-1.3|0.083
74078575|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1||5.1|-4.9|0.970
74078576|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1||7.5|-4.1|0.574
74078577|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.311|TWO_SIDED|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||Week 1||1.7|-5.2|0.311
74078578|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.558|TWO_SIDED|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2||4.1|-7.7|0.558
74078579|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2||11.6|-4.7|0.413
74078580|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.543|TWO_SIDED|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.0|-7.7|0.543
74078581|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.583|TWO_SIDED|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4||4.2|-7.6|0.583
74078582|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.028|TWO_SIDED|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4||22.5|1.8|0.028
74078583|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.087|TWO_SIDED|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4||18.3|-0.9|0.087
73888387|NCT02900378|147309611|OTHER||Differences of least square means|-6.24|STANDARD_ERROR_OF_MEAN|6.69||0.3513|TWO_SIDED|95.0|-19.39|6.91||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without MI/LOCF)||6.91|-19.39|0.3513
74078584|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.632|TWO_SIDED|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8||9.4|-5.6|0.632
74078585|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.016|TWO_SIDED|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8||24.8|3.1|0.016
74078586|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|15.8||||0.009|TWO_SIDED|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8||27.0|4.5|0.009
74078587|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.974|TWO_SIDED|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12||11.6|-11.2|0.974
74078588|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.031|TWO_SIDED|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12||29.3|1.8|0.031
74078589|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.032|TWO_SIDED|95.0|1.8|29.5|||Cochran-Mantel-Haenszel|||Week 12||29.5|1.8|0.032
74078590|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.553|TWO_SIDED|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16||16.9|-9.0|0.553
74078591|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.008|TWO_SIDED|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16||35.8|6.1|0.008
74078592|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.061|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16||28.2|-0.3|0.061
74078593|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.585|TWO_SIDED|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20||18.0|-10.1|0.585
74078594|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.032|TWO_SIDED|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20||32.8|2.0|0.032
74078595|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|8.6||||0.254|TWO_SIDED|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20||23.1|-5.9|0.254
74078596|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.598|TWO_SIDED|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||Week 24||19.8|-11.3|0.598
74078597|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.066|TWO_SIDED|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||Week 24||31.4|-0.4|0.066
74078598|NCT03100344|147711016|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.826|TWO_SIDED|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||Week 24||16.9|-13.5|0.826
74078599|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-10.0||||0.049|TWO_SIDED|95.0|-20.0|0.0|||Kenward-Rogers|||Week 1||0.0|-20.0|0.049
74078600|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-16.9|||<|0.001|TWO_SIDED|95.0|-26.7|-7.0|||Kenward Roger|||Week 1||-7.0|-26.7|<0.001
74078601|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-15.7||||0.002|TWO_SIDED|95.0|-25.6|-5.8|||Kenward Roger|||Week 1||-5.8|-25.6|0.002
74078602|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-9.8||||0.084|TWO_SIDED|95.0|-20.9|1.3|||Kenward Roger|||Week 2||1.3|-20.9|0.084
74078603|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-16.2||||0.004|TWO_SIDED|95.0|-27.2|-5.2|||Kenward Roger|||Week 2||-5.2|-27.2|0.004
74078604|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-14.8||||0.008|TWO_SIDED|95.0|-25.8|-3.8|||Kenward Roger|||Week 2||-3.8|-25.8|0.008
74078605|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-14.0||||0.044|TWO_SIDED|95.0|-27.5|-0.4|||Kenward Roger|||Week 4||-0.4|-27.5|0.044
74078606|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-21.1||||0.002|TWO_SIDED|95.0|-34.7|-7.6|||Kenward Roger|||Week 4||-7.6|-34.7|0.002
74078607|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-15.3||||0.026|TWO_SIDED|95.0|-28.8|-1.8|||Kenward Roger|||Week 4||-1.8|-28.8|0.026
74078608|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-14.8||||0.062|TWO_SIDED|95.0|-30.2|0.7|||Kenward Roger|||Week 8||0.7|-30.2|0.062
74078609|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-23.4||||0.003|TWO_SIDED|95.0|-38.9|-7.9|||Kenward Roger|||Week 8||-7.9|-38.9|0.003
74078610|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-20.6||||0.009|TWO_SIDED|95.0|-36.0|-5.2|||Kenward Roger|||Week 8||-5.2|-36.0|0.009
74078611|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-15.9||||0.022|TWO_SIDED|95.0|-29.4|-2.3|||Kenward Roger|||Week 12||-2.3|-29.4|0.022
74078612|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-23.7|||<|0.001|TWO_SIDED|95.0|-37.1|-10.2|||Kenward Roger|||Week 12||-10.2|-37.1|<0.001
74078613|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-14.7||||0.032|TWO_SIDED|95.0|-28.1|-1.3|||Kenward Roger|||Week 12||-1.3|-28.1|0.032
74078614|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-13.7||||0.07|TWO_SIDED|95.0|-28.6|1.1|||Kenward Roger|||Week 16||1.1|-28.6|0.070
74078615|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-23.7||||0.002|TWO_SIDED|95.0|-38.5|-8.9|||Kenward Roger|||Week 16||-8.9|-38.5|0.002
74078616|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-10.7||||0.154|TWO_SIDED|95.0|-25.6|4.1|||Kenward Roger|||Week 16||4.1|-25.6|0.154
74078617|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-12.1||||0.09|TWO_SIDED|95.0|-26.0|1.9|||Kenward Roger|||Week 20||1.9|-26.0|0.090
74078618|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-15.9||||0.024|TWO_SIDED|95.0|-29.7|-2.1|||Kenward Roger|||Week 20||-2.1|-29.7|0.024
74078619|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-9.5||||0.18|TWO_SIDED|95.0|-23.4|4.4|||Kenward Roger|||Week 20||4.4|-23.4|0.180
74078620|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-13.6||||0.051|TWO_SIDED|95.0|-27.3|0.0|||Kenward Roger|||Week 24||0.0|-27.3|0.051
74078621|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-16.7||||0.016|TWO_SIDED|95.0|-30.2|-3.2|||Kenward Roger|||Week 24||-3.2|-30.2|0.016
74078622|NCT03100344|147711017|SUPERIORITY||mean difference of percentage changes|-6.8||||0.322|TWO_SIDED|95.0|-20.5|6.8|||Kenward Roger|||Week 24||6.8|-20.5|0.322
73886109|NCT03165617|147305930|SUPERIORITY|Success criteria was met as the LL of the 2-sided 95% CI of the VE estimate was greater than 30% (co-primary endpoint)|Absolute Vaccine Efficacy|54.03|||||TWO_SIDED|95.0|44.8|61.71||||||Statistical analysis title - Absolute Vaccine Efficacy, Any Strain Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 30% (co-primary endpoint) using the protocol definition of ILI for the entire age range (≥ 3 to \<18 years of age).||61.71|44.8|
73886110|NCT03165617|147305931|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||62.12|45.67|
73886111|NCT03165617|147305931|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|50.51|||||TWO_SIDED|95.0|38.43|60.22||||||Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||60.22|38.43|
73886112|NCT03165617|147305931|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|53.33|||||TWO_SIDED|95.0|43.38|61.54||||||Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||61.54|43.38|
73886113|NCT03165617|147305931|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|61.85|||||TWO_SIDED|95.0|47.37|72.34||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||72.34|47.37|
74078623|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-10.9||||0.012|TWO_SIDED|95.0|-19.4|-2.4|||Kenward Roger|||Week 1||-2.4|-19.4|0.012
74078624|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-15.4|||<|0.001|TWO_SIDED|95.0|-23.8|-7.1|||Kenward Roger|||Week 1||-7.1|-23.8|<0.001
74078625|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-9.4||||0.029|TWO_SIDED|95.0|-17.8|-0.9|||Kenward Roger|||Week 1||-0.9|-17.8|0.029
74078626|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-21.8|||<|0.001|TWO_SIDED|95.0|-32.0|-11.6|||Kenward Roger|||Week 2||-11.6|-32.0|<0.001
74078627|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-29.1|||<|0.001|TWO_SIDED|95.0|-39.1|-19.1|||Kenward Roger|||Week 2||-19.1|-39.1|<0.001
74078628|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-23.8|||<|0.001|TWO_SIDED|95.0|-34.0|-13.6|||Kenward Roger|||Week 2||-13.6|-34.0|<0.001
74078629|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-21.3|||<|0.001|TWO_SIDED|95.0|-32.1|-10.5|||Kenward Roger|||Week 4||-10.5|-32.1|<0.001
74078630|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-34.8|||<|0.001|TWO_SIDED|95.0|-45.5|-24.2|||Kenward Roger|||Week 4||-24.2|-45.5|<0.001
74078631|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-30.7|||<|0.001|TWO_SIDED|95.0|-41.6|-19.9|||Kenward Roger|||Week 4||-19.9|-41.6|<0.001
74078632|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-22.9|||<|0.001|TWO_SIDED|95.0|-33.2|-12.6|||Kenward Roger|||Week 8||-12.6|-33.2|<0.001
73886114|NCT03165617|147305932|SUPERIORITY|Absolute Vaccine Efficacy (aVE) for 2 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints|Absolute Vaccine Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||62.12|45.67|
73886115|NCT03165617|147305932|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.78|||||TWO_SIDED|95.0|49.01|69.83||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||69.83|49.01|
74078633|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-37.3|||<|0.001|TWO_SIDED|95.0|-47.4|-27.2|||Kenward Roger|||Week 8||-27.2|-47.4|<0.001
74078634|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-34.1|||<|0.001|TWO_SIDED|95.0|-44.4|-23.8|||Kenward Roger|||Week 8||-23.8|-44.4|<0.001
74078635|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-24.1|||<|0.001|TWO_SIDED|95.0|-35.6|-12.5|||Kenward Roger|||Week 12||-12.5|-35.6|<0.001
74078636|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-38.4|||<|0.001|TWO_SIDED|95.0|-49.7|-27.2|||Kenward Roger|||Week 12||-27.2|-49.7|<0.001
74078637|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-30.2|||<|0.001|TWO_SIDED|95.0|-41.7|-18.7|||Kenward Roger|||Week 12||-18.7|-41.7|<0.001
74078638|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-20.9|||<|0.001|TWO_SIDED|95.0|-32.8|-8.9|||Kenward Roger|||Week 16||-8.9|-32.8|<0.001
74078639|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-34.3|||<|0.001|TWO_SIDED|95.0|-46.0|-22.6|||Kenward Roger|||Week 16||-22.6|-46.0|<0.001
74078640|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-28.7|||<|0.001|TWO_SIDED|95.0|-40.7|-16.8|||Kenward Roger|||Week 16||-16.8|-40.7|<0.001
74078641|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-21.1||||0.001|TWO_SIDED|95.0|-33.7|-8.4|||Kenward Roger|||Week 20||-8.4|-33.7|0.001
74078642|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-29.7|||<|0.001|TWO_SIDED|95.0|-42.1|-17.3|||Kenward Roger|||Week 20||-17.3|-42.1|<0.001
74078643|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-27.9|||<|0.001|TWO_SIDED|95.0|-40.6|-15.2|||Kenward Roger|||Week 20||-15.2|-40.6|<0.001
74078644|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-22.4||||0.002|TWO_SIDED|95.0|-36.1|-8.6|||Kenward Roger|||Week 24||-8.6|-36.1|0.002
74078645|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-31.5|||<|0.001|TWO_SIDED|95.0|-44.9|-18.0|||Kenward Roger|||Week 24||-18.0|-44.9|<0.001
74078646|NCT03100344|147711018|SUPERIORITY||mean difference of percentage changes|-30.0|||<|0.001|TWO_SIDED|95.0|-43.8|-16.2|||Kenward Roger|||Week 24||-16.2|-43.8|<0.001
74078647|NCT03100344|147711020|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-3.0|-1.0|||Kenward Roger|||Week 24||-1.0|-3.0|<0.001
74078648|NCT03100344|147711020|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.001|TWO_SIDED|95.0|-3.8|-1.8|||Kenward Roger|||Week 24||-1.8|-3.8|<0.001
74078649|NCT03100344|147711020|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.3|-1.3|||Kenward Roger|||Week 24||-1.3|-3.3|<0.001
74078650|NCT03100344|147711021|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||Kenward Roger|||Week 24||-0.9|-3.0|<0.001
74078651|NCT03100344|147711021|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.6|-1.6|||Kenward Roger|||Week 24||-1.6|-3.6|<0.001
74078652|NCT03100344|147711021|SUPERIORITY||Mean Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-3.1|-1.1|||Kenward Roger|||Week 24||-1.1|-3.1|<0.001
74078653|NCT03100344|147711022|SUPERIORITY||mean difference of percentage changes|-23.8|||<|0.001|TWO_SIDED|95.0|-37.7|-9.9|||Kenward Roger|||Week 24||-9.9|-37.7|<0.001
74078654|NCT03100344|147711022|SUPERIORITY||mean difference of percentage changes|-31.4|||<|0.001|TWO_SIDED|95.0|-45.0|-17.7|||Kenward Roger|||Week 24||-17.7|-45.0|<0.001
74078655|NCT03100344|147711022|SUPERIORITY||mean difference of percentage changes|-29.2|||<|0.001|TWO_SIDED|95.0|-43.2|-15.2|||Kenward Roger|||Week 24||-15.2|-43.2|<0.001
74078656|NCT04633564|147711023|EQUIVALENCE|The equivalence region is (0.73, 1.36).|Risk Ratio (RR)|0.96|||||TWO_SIDED|90.0|0.83|1.12||||||||1.12|0.83|
74078657|NCT01935674|147711039|SUPERIORITY||Mean Difference (Net)|12.7||||0.003|TWO_SIDED|95.0|2.9|22.5||P-value from Wilcoxon rank-sum test; significance threshold set at α = 0.05. No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|Two-sided test; analysis based on intention-to-treat population.||Comparison of percentage change in fasting total cholesterol from baseline to week 12 between rosuvastatin and PI/r switch groups. Wilcoxon rank-sum test used. Study powered to detect a 15% difference with 80% power and α = 0.05. All participants included in intention-to-treat analysis.||22.5|2.9|0.003
74078658|NCT01521780|147711053|SUPERIORITY_OR_OTHER||Within subject coefficient of variation|0.0803|||||ONE_SIDED|90.0||0.1163||||||||0.1163||
73888388|NCT02900378|147309612|OTHER||Odds Ratio (OR)|1.228|||||TWO_SIDED|95.0|0.882|1.708||||||FAS population||1.708|0.882|
74078659|NCT01521780|147711054|SUPERIORITY_OR_OTHER||Within subject coefficient of variation|0.0555|||||ONE_SIDED|90.0||0.0733||||||||0.0733||
74078660|NCT03043872|147711058|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0047|TWO_SIDED|95.0|0.591|0.909||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. The global cohort interim analysis of OS was based on a Lan-DeMets alpha spending function with O'Brien Fleming type boundary, using the actual number of events observed as a proportion of the planned total. Boundary for declaring statistical significance was 0.0178 for a 4% overall alpha. Hazard Ratio (HR) \<1 favors D + EP to be associated with a longer OS than EP.||0.909|0.591|0.0047
74078661|NCT03043872|147711059|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0032|TWO_SIDED|95.0|0.625|0.91||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP.||0.910|0.625|0.0032
74078662|NCT03043872|147711059|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0451|TWO_SIDED|95.0|0.682|0.995||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|"D + T + EP vs EP. The alpha level applied at the global cohort final analysis was adjusted (using a generalized Haybittle-Peto method) to account for actual alpha spent at the interim analysis based on the actual final total number of events, and thus maintain control of overall Type I error. Boundary for declaring statistical significance was 0.0418 for a 5% overall alpha.~HR \<1 favors D + T + EP to be associated with a longer OS than EP."||0.995|0.682|0.0451
73888389|NCT02900378|147309613|OTHER||Odds Ratio (OR)|1.251|||||TWO_SIDED|95.0|0.895|1.748||||||FAS subset without AE/SAE||1.748|0.895|
73888390|NCT02900378|147309614|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.634|2.464||||||FAS population||2.464|0.634|
74078663|NCT03043872|147711060|OTHER||Hazard Ratio (HR)|0.65||||0.0664|TWO_SIDED|95.0|0.414|1.029||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.029|0.414|0.0664
74078664|NCT03043872|147711061|OTHER||Hazard Ratio (HR)|0.75||||0.1455|TWO_SIDED|95.0|0.504|1.106||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.106|0.504|0.1455
74078665|NCT03043872|147711061|OTHER||Hazard Ratio (HR)|0.65||||0.0314|TWO_SIDED|95.0|0.439|0.964||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||0.964|0.439|0.0314
74078666|NCT03043872|147711062|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4352|TWO_SIDED|95.0|0.89|1.309||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer OS than D + EP.||1.309|0.890|0.4352
74078667|NCT03043872|147711063|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0157|TWO_SIDED|95.0|0.665|0.959||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer PFS than EP.||0.959|0.665|0.0157
74078668|NCT03043872|147711063|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0568|TWO_SIDED|95.0|0.696|1.005||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer PFS than EP.||1.005|0.696|0.0568
74078669|NCT03043872|147711063|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.754|TWO_SIDED|95.0|0.857|1.235||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer PFS than D + EP.||1.235|0.857|0.7540
73888391|NCT02900378|147309615|OTHER||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.644|2.544||||||FAS subset without AE/SAE||2.544|0.644|
74078670|NCT03043872|147711064|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0177|TWO_SIDED|95.0|1.086|2.401||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + EP vs EP. An odds ratio \>1 favors D + EP.||2.401|1.086|0.0177
74078671|NCT03043872|147711064|SUPERIORITY||Odds Ratio (OR)|1.19||||0.3611|TWO_SIDED|95.0|0.817|1.746||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + T + EP vs EP. An odds ratio \>1 favors D + T + EP.||1.746|0.817|0.3611
74078672|NCT03043872|147711076|OTHER||Hazard Ratio (HR)|0.86||||0.447|TWO_SIDED|95.0|0.574|1.277||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer OS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.277|0.574|0.4470
74078673|NCT03043872|147711077|OTHER||Hazard Ratio (HR)|0.97||||0.8934|TWO_SIDED|95.0|0.661|1.437||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.437|0.661|0.8934
74078674|NCT03043872|147711077|OTHER||Hazard Ratio (HR)|0.72||||0.1035|TWO_SIDED|95.0|0.487|1.068||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.068|0.487|0.1035
74078675|NCT03043872|147711077|OTHER||Hazard Ratio (HR)|0.76||||0.1673|TWO_SIDED|95.0|0.522|1.116||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer PFS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.116|0.522|0.1673
74078676|NCT03043872|147711078|OTHER||Odds Ratio (OR)|1.39||||0.432|TWO_SIDED|95.0|0.61|3.244||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + EP vs EP. An odds ratio \>1 favors D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||3.244|0.610|0.4320
74078677|NCT03043872|147711078|OTHER||Odds Ratio (OR)|2.07||||0.0986|TWO_SIDED|95.0|0.874|5.118||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + T + EP vs EP. An odds ratio \>1 favors D + T + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||5.118|0.874|0.0986
74078678|NCT02433977|147711093|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
74078679|NCT02433977|147711094|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
74078680|NCT02433977|147711095|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
74078681|NCT02433977|147711096|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
73888392|NCT02900378|147309616|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.863|1.811||||||FAS population||1.811|0.863|
74078682|NCT02433977|147711098|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
74078683|NCT02433977|147711100|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
74078684|NCT02433977|147711101|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
74078685|NCT02433977|147711102|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
74078686|NCT00772603|147711105|SUPERIORITY_OR_OTHER||Median Difference (Net)|-18.3|||=|0.003|TWO_SIDED|95.0|-30.4|-5.8||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||-5.80|-30.40|=0.003
74078687|NCT00772603|147711105|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.3|||=|0.078|TWO_SIDED|95.0|-22.3|1.2||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||1.20|-22.30|=0.078
74078688|NCT00772603|147711106|SUPERIORITY_OR_OTHER||Median Difference (Net)|-33.0|||=|0.003|TWO_SIDED|95.0|-33.0|-6.3||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||-6.30|-33.00|=0.003
74078689|NCT00772603|147711106|SUPERIORITY_OR_OTHER||Median Difference (Net)|-3.3|||=|0.589|TWO_SIDED|95.0|-16.2|9.7||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||9.70|-16.20|=0.589
74078690|NCT00772603|147711107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.983|||=|0.018|TWO_SIDED|95.0|1.126|3.494|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.||3.494|1.126|=0.018
74078691|NCT00772603|147711107|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||=|0.075||95.0|0.95|2.937|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.||2.937|0.950|=0.075
74078692|NCT00772603|147711108|SUPERIORITY_OR_OTHER||||||=|0.013||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.||||=0.013
74078693|NCT00772603|147711108|SUPERIORITY_OR_OTHER||||||=|0.528||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.||||=0.528
74078694|NCT00772603|147711109|SUPERIORITY_OR_OTHER||||||=|0.008||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.||||=0.008
74078695|NCT00772603|147711109|SUPERIORITY_OR_OTHER||||||=|0.0546||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.||||=0.0546
74078696|NCT00836004|147711110|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|99.69||||||90.0|93.88|105.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.85|93.88|
74078697|NCT00836004|147711111|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.62|102.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.19|90.62|
74078698|NCT00836004|147711112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.17||||||90.0|92.14|102.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.48|92.14|
74078699|NCT00446966|147711121|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
74078700|NCT00859521|147711134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.7||||||90.0|92.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|92.4|
74078701|NCT00859521|147711135|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|96.9|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|96.9|
74078702|NCT00859521|147711136|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.8||||||90.0|97.2|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|97.2|
74078703|NCT02888756|147711138|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Analyzed for week 6, to provide statistical information for decision on execution of intracellular cytokine staining (ICS).||||0.14
74078704|NCT00834132|147711154|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|94.81||||||90.0|84.77|106.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.04|84.77|
73888393|NCT02900378|147309617|OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.865|1.834||||||FAS subset without AE/SAE||1.834|0.865|
73888394|NCT02900378|147309618|OTHER|||||||0.1814|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS)||||0.1814
74078705|NCT00834132|147711155|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.89||||||90.0|96.0|106.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.03|96.00|
74078706|NCT00834132|147711156|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.14||||||90.0|96.05|106.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.49|96.05|
74078707|NCT02718963|147711170|OTHER||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare the Videofluoroscopic swallowing study(VFSS) kinematic variables, VDS, PAS, and high resolution manometry (HRM) variables between the neuromuscular electrical stimulation session and the control session in swallowing thin fluid and thick fluid for healthy, dysphagic and whole participants. Mann-Whitney test was used to compare the differences of VFSS variables, VDS, PAS, and HRM variables between the healthy participants and dysphagic participants.||||< 0.05
74078708|NCT00836472|147711186|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.41||||||90.0|88.43|105.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.10|88.43|
74078709|NCT00836472|147711187|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.78||||||90.0|95.14|102.57|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.57|95.14|
74078710|NCT00836472|147711188|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.52||||||90.0|94.44|102.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.78|94.44|
74078711|NCT00836472|147711189|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.08||||||90.0|89.6|98.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.77|89.60|
74078712|NCT00836472|147711190|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.33||||||90.0|92.6|100.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.21|92.60|
74078713|NCT00836472|147711191|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.01||||||90.0|92.18|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.00|92.18|
74078714|NCT01695239|147711192|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
74078715|NCT01695239|147711192|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
74078716|NCT01695239|147711192|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
74078717|NCT03552484|147711237|SUPERIORITY||Median Difference (Final Values)|0.05||||0.59|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Within-group paired t-tests and between-group paired t-tests||||0.59
74078718|NCT03552484|147711238|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.59|TWO_SIDED|95.0||||Between-group comparison|t-test, 2 sided|||||||0.59
74078719|NCT03552484|147711239|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.62|TWO_SIDED|||||Between-group comparison of change in Multidimensional Caregiver Strain Index|t-test, 2 sided|||||||0.62
74078720|NCT03246503|147711261|OTHER||Pearson correlation coefficient|0.82|||<|0.001|TWO_SIDED|95.0|0.77|0.87||statistical significance of Pearson correlation coefficient|Pearson correlation coefficient||Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.|Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.||.87|0.77|<.001
74078721|NCT03246503|147711262|OTHER|t-statistic from regression analysis|intercept of regression line|4.13|||<|0.001|TWO_SIDED|95.0|3.35|4.91|||Regression, Linear|||||4.91|3.35|<.001
74078722|NCT03246503|147711263|OTHER|t-statistic from regression analysis|Slope|0.68|||<|0.001|TWO_SIDED|95.0|0.6|0.76|||Regression, Linear|||||0.76|0.60|<.001
74078723|NCT01492439|147711303|SUPERIORITY_OR_OTHER|||||||0.029||||||This applies to Semester 1.|t-test, 1 sided|||||||0.029
74078724|NCT01492439|147711303|SUPERIORITY_OR_OTHER|||||||0.225||||||This applies to semester 2.|t-test, 1 sided|||||||0.225
74078725|NCT01492439|147711304|SUPERIORITY_OR_OTHER|||||||0.247||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA|||||||0.247
74078726|NCT01492439|147711304|SUPERIORITY_OR_OTHER|||||||0.747||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA|||||||0.747
74078727|NCT01492439|147711304|SUPERIORITY_OR_OTHER|||||||0.582||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA|||||||0.582
74078728|NCT01492439|147711305|SUPERIORITY_OR_OTHER|||||||0|||||||ANCOVA|||||||0.000
74078729|NCT01492439|147711306|SUPERIORITY_OR_OTHER|||||||0.95||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA|||||||0.950
74078730|NCT01492439|147711306|SUPERIORITY_OR_OTHER|||||||0.027||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA|||||||0.027
74078731|NCT01492439|147711306|SUPERIORITY_OR_OTHER|||||||0.639||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA|||||||0.639
74078732|NCT01492439|147711307|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANCOVA|||||||0.008
74078733|NCT01492439|147711308|SUPERIORITY_OR_OTHER|||||||0.314||||||This applies to Trial 1 on the CVLT.|ANCOVA|||||||0.314
74078734|NCT01492439|147711308|SUPERIORITY_OR_OTHER|||||||0.242||||||This applies to the total score of trials 1-4 (total free recall) of the CVLT.|ANCOVA|||||||0.242
74078735|NCT01492439|147711308|SUPERIORITY_OR_OTHER|||||||0.669||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA|||||||0.669
74078736|NCT01492439|147711309|SUPERIORITY_OR_OTHER|||||||0.139||||||This applies to the 'trial 1' subtest of the CVLT.|ANCOVA|||||||0.139
74078737|NCT01492439|147711309|SUPERIORITY_OR_OTHER|||||||0.269||||||This applies to the total of trials 1-4 (total free recall) of the CVLT.|ANCOVA|||||||0.269
74078738|NCT01492439|147711309|SUPERIORITY_OR_OTHER|||||||0.666||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA|||||||0.666
74078739|NCT01492439|147711310|SUPERIORITY_OR_OTHER|||||||0.391|||||||ANCOVA|||||||0.391
74078740|NCT01492439|147711311|SUPERIORITY_OR_OTHER|||||||0.958|||||||ANCOVA|||||||0.958
74078741|NCT01492439|147711312|SUPERIORITY_OR_OTHER|||||||0.754||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA|||||||0.754
74078742|NCT01492439|147711312|SUPERIORITY_OR_OTHER|||||||0.518||||||This applies to the 'backward' sequence of the Digit Span Test.|ANCOVA|||||||0.518
74078743|NCT01492439|147711312|SUPERIORITY_OR_OTHER|||||||0.531||||||This applies to the total score (forward+backwards) on the Digit Span Test.|ANCOVA|||||||0.531
74078744|NCT01492439|147711313|SUPERIORITY_OR_OTHER|||||||0.802||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA|||||||0.802
74078745|NCT01492439|147711313|SUPERIORITY_OR_OTHER|||||||0.091||||||This applies to the 'backwards' sequence of the Digit Span Test.|ANCOVA|||||||0.091
74078746|NCT01492439|147711313|SUPERIORITY_OR_OTHER|||||||0.171||||||This applies to the total score (forward + backwards) on the Digit Span Test.|ANCOVA|||||||0.171
74078747|NCT01492439|147711314|SUPERIORITY_OR_OTHER|||||||0.267|||||||ANCOVA|||||||0.267
74078748|NCT01492439|147711315|SUPERIORITY_OR_OTHER|||||||0.527|||||||ANCOVA|||||||0.527
74078749|NCT01492439|147711316|SUPERIORITY_OR_OTHER|||||||0.852||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA|||||||0.852
74078750|NCT01492439|147711316|SUPERIORITY_OR_OTHER|||||||0.637||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA|||||||0.637
74078751|NCT01492439|147711317|SUPERIORITY_OR_OTHER|||||||0.612||||||This applies to the total number of correct categories on the WCST|ANCOVA|||||||0.612
74078752|NCT01492439|147711318|SUPERIORITY_OR_OTHER|||||||0.156||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA|||||||0.156
74078753|NCT01492439|147711318|SUPERIORITY_OR_OTHER|||||||0.926||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA|||||||0.926
74078754|NCT01492439|147711319|SUPERIORITY_OR_OTHER|||||||0.843|||||||ANCOVA|||This applies to the total number of categories on the WCST.||||0.843
74078755|NCT01492439|147711320|SUPERIORITY_OR_OTHER|||||||0.129||||||This applies to the total number of errors made on the DVT.|ANCOVA|||||||0.129
74078756|NCT01492439|147711321|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|||This applies to the total time taken to complete the DVT.||||0.004
74078757|NCT01492439|147711322|SUPERIORITY_OR_OTHER|||||||0.853|||||||ANCOVA|This applies to the total number of errors on the DVT.||||||0.853
74078758|NCT01492439|147711323|SUPERIORITY_OR_OTHER|||||||0.468|||||||ANCOVA|||This applies to the total time taken to complete the DVT.||||0.468
74078759|NCT00488774|147711324|SUPERIORITY_OR_OTHER|||||||0.467|||||||Chi-squared|||||||0.467
74078760|NCT00488774|147711324|SUPERIORITY_OR_OTHER|||||||0.081|||||||Chi-squared|||||||0.081
74078761|NCT00488774|147711324|SUPERIORITY_OR_OTHER|||||||0.145|||||||Chi-squared|||||||0.145
74078762|NCT00488774|147711325|SUPERIORITY_OR_OTHER|||||||0.832|||||||Chi-squared|||||||0.832
74078763|NCT00488774|147711325|SUPERIORITY_OR_OTHER|||||||0.37|||||||Chi-squared|||||||0.370
74078764|NCT00488774|147711325|SUPERIORITY_OR_OTHER|||||||0.702|||||||Chi-squared|||||||0.702
74078765|NCT04590027|147711328|NON_INFERIORITY|power calculation was not recorded Definition of non inferiority: two point difference of pain score at the measurement times|||||<|0.05|||||||ANCOVA|To rule out confounders due to an age difference, the ANCOVA test was applied to compare the differences in pain scores age-unrelatedly.|||Fisher Yates Test to compare the requirement of resue medication|||<0.05
74078766|NCT04590027|147711329|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
74078767|NCT00462228|147711371|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.||||0.55
74078768|NCT00462228|147711371|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.||||1.00
74078769|NCT00462228|147711371|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.||||0.45
74078770|NCT00462228|147711371|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.||||0.43
74078771|NCT00462228|147711372|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||6 week comparison,alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores||||0.23
74078772|NCT00462228|147711372|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.||||0.022
74078773|NCT00462228|147711372|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores.||||0.06
74078774|NCT00462228|147711372|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.||||0.027
74078775|NCT00462228|147711373|SUPERIORITY_OR_OTHER|||||||1||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.||||1.0
74078776|NCT00462228|147711373|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.||||0.55
74078777|NCT00462228|147711373|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.||||0.81
74078778|NCT00462228|147711373|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.||||0.57
74078779|NCT00462228|147711374|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.||||0.55
74078780|NCT00462228|147711374|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.||||1.0
74078781|NCT00462228|147711374|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.||||0.17
74078782|NCT00462228|147711374|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.||||0.64
74078783|NCT00462228|147711375|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R total recall scores.||||0.34
74078784|NCT00462228|147711375|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.||||1.0
74078785|NCT00462228|147711375|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall scores.||||0.54
74078786|NCT00462228|147711375|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.||||0.91
74078787|NCT00462228|147711376|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.||||0.34
74078788|NCT00462228|147711376|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.||||0.55
74078789|NCT00462228|147711376|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.||||0.37
73888395|NCT02900378|147309618|OTHER|||||||0.3315|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS without AE/SAE)||||0.3315
74078790|NCT00462228|147711376|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.||||0.95
74078791|NCT00462228|147711377|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.||||0.75
74078792|NCT00462228|147711377|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.||||0.51
74078793|NCT00462228|147711377|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.||||0.31
73886116|NCT03165617|147305932|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|59.66|||||TWO_SIDED|95.0|49.08|68.05||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||68.05|49.08|
74078794|NCT00462228|147711377|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.||||0.46
74078795|NCT00462228|147711378|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.||||0.34
74078796|NCT00462228|147711378|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.||||0.75
74078797|NCT00462228|147711378|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.||||0.37
74078798|NCT00462228|147711378|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.||||0.45
74078799|NCT00824291|147711379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.12||||0.002|TWO_SIDED|95.0|0.78|3.46|||ANCOVA|||||3.46|0.78|0.002
74078800|NCT00824291|147711380|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.33||||0.067|TWO_SIDED|95.0|-0.09|2.76|||ANCOVA|||||2.76|-0.09|0.067
74078801|NCT00824291|147711381|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
74078802|NCT00824291|147711382|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
74078803|NCT00824291|147711383|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.04|TWO_SIDED|95.0|0.01|0.44|||ANCOVA|||||0.44|0.01|0.040
74078804|NCT00824291|147711384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26||||0.035|TWO_SIDED|95.0|0.16|4.37|||ANCOVA|||||4.37|0.16|0.035
74078805|NCT00824291|147711385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44||||0.041|TWO_SIDED|95.0|0.1|4.78|||ANCOVA|||||4.78|0.10|0.041
74078806|NCT00824291|147711386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.145|TWO_SIDED|95.0|-0.13|0.91|||ANCOVA|||||0.91|-0.13|0.145
73888396|NCT02900378|147309618|OTHER|||||||0.2414|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS)||||0.2414
74078807|NCT01648582|147711420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.74|-0.4||||||||-0.40|-0.74|
74078808|NCT01648582|147711420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.18|||||TWO_SIDED|95.0|-0.35|-0.01||||||||-0.01|-0.35|
74078809|NCT01648582|147711421|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.77|-0.38||||||||-0.38|-0.77|
73888397|NCT02900378|147309618|OTHER|||||||0.1793|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS without AE/SAE)||||0.1793
74078810|NCT01648582|147711421|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.33|-0.06||||||||-0.06|-0.33|
74078811|NCT01648582|147711422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||\<7.0% Week 26||||<0.001
74078812|NCT01648582|147711422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||\<7.0 Week 26||||0.004
74078813|NCT01648582|147711422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 26||||<0.001
74078814|NCT01648582|147711422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 26||||<0.001
74078815|NCT01648582|147711422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<7.0% Week 52||||<0.001
74078816|NCT01648582|147711422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Fisher Exact|||\<7.0% Week 52||||0.002
74078817|NCT01648582|147711422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 52||||<0.001
74078818|NCT01648582|147711422|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 52||||<0.001
74078819|NCT01648582|147711423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.24||||0.177|TWO_SIDED|95.0|-0.11|0.59|||Mixed Models Analysis|||Week 26||0.59|-0.11|0.177
74078820|NCT01648582|147711423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.88|||<|0.001|TWO_SIDED|95.0|0.53|1.23|||Mixed Models Analysis|||Week 26||1.23|0.53|<0.001
74078821|NCT01648582|147711423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.518|TWO_SIDED|95.0|-0.25|0.5|||Mixed Models Analysis|||Week 52||0.50|-0.25|0.518
74078822|NCT01648582|147711423|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.82|||<|0.001|TWO_SIDED|95.0|0.45|1.2|||Mixed Models Analysis|||Week 52||1.20|0.45|<0.001
74078823|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|||<|0.001|TWO_SIDED|95.0|0.42|0.88|||Mixed Models Analysis|||Morning pre-meal, Week 26||0.88|0.42|<0.001
74078824|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.94|||<|0.001|TWO_SIDED|95.0|0.71|1.17|||Mixed Models Analysis|||Morning pre-meal, Week 26||1.17|0.71|<0.001
73888398|NCT02900378|147309619|OTHER||Odds Ratio (OR)|0.821|||||TWO_SIDED|95.0|0.462|1.457||||||Increased levels (\>= 10% increase) of non sedentary daytime physical activity at Week 12||1.457|0.462|
73888399|NCT02900378|147309620|OTHER|||||||0.0516|||||||Chi-squared|||Week 4||||0.0516
73888400|NCT02900378|147309620|OTHER|||||||0.9025|||||||Chi-squared|||Week 8||||0.9025
73888401|NCT02900378|147309620|OTHER|||||||0.6713|||||||Chi-squared|||Week 12||||0.6713
74078825|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.49||||0.024|TWO_SIDED|95.0|-0.92|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26||-0.07|-0.92|0.024
74078826|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.11||||0.617|TWO_SIDED|95.0|-0.53|0.32|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26||0.32|-0.53|0.617
74078827|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.35||||0.055|TWO_SIDED|95.0|-0.7|0.01|||Mixed Models Analysis|||Mid-day pre-meal, Week 26||0.01|-0.70|0.055
74078828|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.03||||0.855|TWO_SIDED|95.0|-0.32|0.39|||Mixed Models Analysis|||Mid-day pre-meal, Week 26||0.39|-0.32|0.855
74078829|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.05|||<|0.001|TWO_SIDED|95.0|-1.46|-0.64|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26||-0.64|-1.46|<0.001
74078830|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.004|TWO_SIDED|95.0|-1.01|-0.19|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26||-0.19|-1.01|0.004
74078831|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.97|-0.29|||Mixed Models Analysis|||Evening pre-meal, Week 26||-0.29|-0.97|<0.001
74078832|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.489|TWO_SIDED|95.0|-0.45|0.22|||Mixed Models Analysis|||Evening pre-meal, Week 26||0.22|-0.45|0.489
74078833|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.89|||<|0.001|TWO_SIDED|95.0|-1.3|-0.48|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26||-0.48|-1.30|<0.001
74078834|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.47||||0.024|TWO_SIDED|95.0|-0.88|-0.06|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26||-0.06|-0.88|0.024
74078835|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.79|||<|0.001|TWO_SIDED|95.0|-1.17|-0.41|||Mixed Models Analysis|||Bedtime, Week 26||-0.41|-1.17|<0.001
74078836|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.35||||0.067|TWO_SIDED|95.0|-0.73|-0.03|||Mixed Models Analysis|||Bedtime, Week 26||-0.03|-0.73|0.067
74078837|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.77|||<|0.001|TWO_SIDED|95.0|0.52|1.01|||Mixed Models Analysis|||Morning pre-meal, Week 52||1.01|0.52|<0.001
74078838|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|0.82|1.31|||Mixed Models Analysis|||Morning pre-meal, Week 52||1.31|0.82|<0.001
74078839|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.53||||0.025|TWO_SIDED|95.0|-1.0|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52||-0.07|-1.00|0.025
74078840|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21||||0.384|TWO_SIDED|95.0|-0.67|0.26|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52||0.26|-0.67|0.384
74078841|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.43||||0.024|TWO_SIDED|95.0|-0.8|-0.06|||Mixed Models Analysis|||Mid-day pre-meal, Week 52||-0.06|-0.80|0.024
74078842|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.05||||0.783|TWO_SIDED|95.0|-0.32|0.42|||Mixed Models Analysis|||Mid-day pre-meal, Week 52||0.42|-0.32|0.783
74078843|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.63||||0.004|TWO_SIDED|95.0|-1.07|-0.2|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52||-0.20|-1.07|0.004
74078844|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.48||||0.029|TWO_SIDED|95.0|-0.92|-0.05|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52||-0.05|-0.92|0.029
74078845|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-1.01|-0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52||-0.27|-1.01|<0.001
74078846|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.603|TWO_SIDED|95.0|-0.47|0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52||0.27|-0.47|0.603
74078847|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.26|-0.41|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52||-0.41|-1.26|<0.001
74078848|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.039|TWO_SIDED|95.0|-0.87|-0.02|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52||-0.02|-0.87|0.039
74078849|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.99|||<|0.001|TWO_SIDED|95.0|-1.39|-0.6|||Mixed Models Analysis|||Bedtime, Week 52||-0.60|-1.39|<0.001
74078850|NCT01648582|147711424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.59||||0.003|TWO_SIDED|95.0|-0.98|-0.2|||Mixed Models Analysis|||Bedtime, Week 52||-0.20|-0.98|0.003
74078851|NCT01648582|147711425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.41|STANDARD_ERROR_OF_MEAN|3.831||0.352|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5 mg, Week 26||||0.352
74078852|NCT01648582|147711425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|31.17|STANDARD_ERROR_OF_MEAN|3.761||0.352|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 26||||0.352
74078853|NCT01648582|147711425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.12|STANDARD_ERROR_OF_MEAN|4.147||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5, Week 52||||0.025
74078854|NCT01648582|147711425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|36.64|STANDARD_ERROR_OF_MEAN|4.061||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 52||||0.025
74078855|NCT01648582|147711426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|36.57|STANDARD_ERROR_OF_MEAN|2.977||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 26||||0.025
74078856|NCT01648582|147711426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.42|STANDARD_ERROR_OF_MEAN|2.94||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 26||||0.025
74078857|NCT01648582|147711426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|41.02|STANDARD_ERROR_OF_MEAN|2.9||0.029|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 52||||0.029
74078858|NCT01648582|147711426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|35.19|STANDARD_ERROR_OF_MEAN|2.864||0.029|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 52||||0.029
74078859|NCT01648582|147711429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Overall p-value|Mixed Models Analysis|||Week 26 SBP||||0.008
74078860|NCT01648582|147711429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.584||||||Overall p-value|Mixed Models Analysis|||Week 26 DBP||||0.584
74078861|NCT01648582|147711429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169||||||Overall p-value|Mixed Models Analysis|||Week 52 SBP||||0.169
74078862|NCT01648582|147711429|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||Overall p-value|Mixed Models Analysis|||Week 52 DBP||||0.110
74078863|NCT01648582|147711430|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 26||||<0.001
74078864|NCT01648582|147711430|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 52||||<0.001
74078865|NCT01648582|147711437|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Week 26|Mixed Models Analysis|||||||<0.001
74078866|NCT01648582|147711437|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 52||||<0.001
74078867|NCT01648582|147711438|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 26||||<0.001
74078868|NCT01648582|147711438|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 52||||<0.001
74078869|NCT03437265|147711455|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
74078870|NCT03437265|147711456|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
74078871|NCT03437265|147711457|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
74078872|NCT03437265|147711458|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
74078873|NCT03437265|147711459|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
74078874|NCT03437265|147711460|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented. The Geometric CV for glycolic acid was Not Calculated (appears as 0%).|||
74078875|NCT03437265|147711461|OTHER||||||||||||||||||Summary of the number of bowel movements per time period for the PD analysis set|||
74078876|NCT03437265|147711462|OTHER||||||||||||||||||The time (in minutes) to achieve clear effluent/time to turbid contents is presented for the PD analysis set.|||
74078877|NCT00840476|147711477|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.26||||||90.0|93.12|107.95|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.95|93.12|
74078878|NCT00840476|147711478|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|105.14||||||90.0|100.27|110.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.25|100.27|
74078879|NCT00840476|147711479|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|104.33||||||90.0|99.16|109.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.76|99.16|
74078880|NCT00835263|147711480|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.23||||||90.0|100.78|105.73|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.73|100.78|
74078881|NCT00835263|147711481|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.31||||||90.0|100.75|105.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.93|100.75|
74078882|NCT00835263|147711482|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|102.14||||||90.0|100.06|104.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.26|100.06|
74078883|NCT00848536|147711483|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||0.5|-0.9|
74078884|NCT00848536|147711484|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.8|0.6|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||00.6|-0.8|
74078885|NCT00848536|147711485|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||0.5|-0.9|
74078886|NCT03261167|147711525|OTHER||Difference|18.1|||||TWO_SIDED|95.0|1.1|35.0||||||||35.0|1.1|
74078887|NCT03261167|147711526|OTHER||Adjusted rate difference|33.1|||||TWO_SIDED|95.0|17.0|49.2|||||Week 2, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||49.2|17.0|
74078888|NCT03261167|147711526|OTHER||Adjusted rate difference|21.7|||||TWO_SIDED|95.0|4.9|38.5|||||Week 4, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||38.5|4.9|
74078889|NCT03261167|147711526|OTHER||Adjusted rate difference|18.4|||||TWO_SIDED|95.0|1.3|35.5|||||Week 6, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||35.5|1.3|
74078890|NCT03261167|147711526|OTHER||Adjusted rate difference|12.9|||||TWO_SIDED|95.0|-4.2|30.1|||||Week 12, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||30.1|-4.2|
74078891|NCT03261167|147711526|OTHER||Adjusted rate difference|-5.6|||||TWO_SIDED|95.0|-20.9|9.8|||||Week 2, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||9.8|-20.9|
74078892|NCT03261167|147711526|OTHER||Adjusted rate difference|-8.6|||||TWO_SIDED|95.0|-23.0|5.9|||||Week 4, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||5.9|-23.0|
74078893|NCT03261167|147711526|OTHER||Adjusted rate difference|-12.1|||||TWO_SIDED|95.0|-27.5|3.2|||||Week 6, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||3.2|-27.5|
74078894|NCT03261167|147711526|OTHER||Adjusted rate difference|-9.6|||||TWO_SIDED|95.0|-27.2|7.9|||||Week 12, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||7.9|-27.2|
74078895|NCT03261167|147711526|OTHER||Adjusted rate difference|-8.6|||||TWO_SIDED|95.0|-21.9|4.7|||||Week 2, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||4.7|-21.9|
74078896|NCT03261167|147711526|OTHER||Adjusted rate difference|-10.4|||||TWO_SIDED|95.0|-24.3|3.4|||||Week 4, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||3.4|-24.3|
74078897|NCT03261167|147711526|OTHER||Adjusted rate difference|-8.9|||||TWO_SIDED|95.0|-23.8|6.0|||||Week 6, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||6.0|-23.8|
74078898|NCT03261167|147711526|OTHER||Adjusted rate difference|-0.1|||||TWO_SIDED|95.0|-17.7|17.4|||||Week 12, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||17.4|-17.7|
73888402|NCT02900378|147309621|OTHER|||||||0.0029|||||||Chi-squared|||Week 4||||0.0029
73888403|NCT02900378|147309621|OTHER|||||||0.7754|||||||Chi-squared|||Week 8||||0.7754
74078899|NCT03261167|147711526|OTHER||Adjusted rate difference|-9.9|||||TWO_SIDED|95.0|-26.4|6.5|||||Week 2, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||6.5|-26.4|
74078900|NCT03261167|147711526|OTHER||Adjusted rate difference|-6.7|||||TWO_SIDED|95.0|-23.6|10.3|||||Week 4, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||10.3|-23.6|
74078901|NCT03261167|147711526|OTHER||Adjusted rate difference|-1.5|||||TWO_SIDED|95.0|-18.8|15.7|||||Week 6, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||15.7|-18.8|
74078902|NCT03261167|147711526|OTHER||Adjusted rate difference|-0.5|||||TWO_SIDED|95.0|-18.8|17.9|||||Week 12, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||17.9|-18.8|
74078903|NCT03261167|147711527|OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-0.75|-0.22|||||Week 2, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.22|-0.75|
74078904|NCT03261167|147711527|OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-0.71|-0.13|||||Week 4, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.13|-0.71|
74078905|NCT03261167|147711527|OTHER||Mean Difference (Net)|-0.37|||||TWO_SIDED|95.0|-0.71|-0.04|||||Week 6, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.04|-0.71|
74078906|NCT03261167|147711527|OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.51|-0.02|||||Week 12, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.02|-0.51|
74078907|NCT03261167|147711527|OTHER||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.27|0.42|||||Week 2, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.42|-0.27|
74078908|NCT03261167|147711527|OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.25|0.46|||||Week 4, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.46|-0.25|
74078909|NCT03261167|147711527|OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.37|0.33|||||Week 6, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.33|-0.37|
74078910|NCT03261167|147711527|OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.19|0.38|||||Week 12, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.38|-0.19|
74078911|NCT03261167|147711527|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.23|0.43|||||Week 2, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.43|-0.23|
74078912|NCT03261167|147711527|OTHER||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.17|0.52|||||Week 4, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.52|-0.17|
74078913|NCT03261167|147711527|OTHER||Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-0.2|0.48|||||Week 6, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.48|-0.20|
74078914|NCT03261167|147711527|OTHER||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.25|0.34|||||Week 12, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.34|-0.25|
74078915|NCT03261167|147711527|OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|-0.08|0.63|||||Week 2, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.63|-0.08|
74078916|NCT03261167|147711527|OTHER||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.23|0.51|||||Week 4, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.51|-0.23|
74078917|NCT03261167|147711527|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.33|0.38|||||Week 6, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.38|-0.33|
74078918|NCT03261167|147711527|OTHER||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.31|0.47|||||Week 12, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.47|-0.31|
74078919|NCT03261167|147711528|OTHER||Mean Difference (Net)|-0.24|||||TWO_SIDED|95.0|-0.48|0.0|||||Week 2. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.00|-0.48|
74078920|NCT03261167|147711528|OTHER||Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.42|0.09|||||Week 4. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.09|-0.42|
74078921|NCT03261167|147711528|OTHER||Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.37|0.08|||||Week 6. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.08|-0.37|
74078922|NCT03261167|147711528|OTHER||Mean Difference (Net)|-0.28|||||TWO_SIDED|95.0|-0.52|-0.04|||||Week 12. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.04|-0.52|
74078923|NCT00835146|147711538|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.9||||||90.0|91.8|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|91.8|
74078924|NCT00835146|147711539|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|93.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|93.3|
74078925|NCT03364192|147711555|OTHER|Multilevel modeling adapted for multiple-baseline design comparing participant goal attainment before, during, and after peer-delivered Whole Health Coaching.|||||<|0.05|||||||Multilevel Modeling|||||||<0.05
74078926|NCT05133180|147711565|SUPERIORITY|The following null hypothesis is defined on this endpoint: the number of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min at week 4 in cenegermin (rhNGF) is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|Odds Ratio (OR)|16.946|||<|0.001|TWO_SIDED|95.0|3.412|84.165||P-value of treatment variable from logistic regression model on the number of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min|Regression, Logistic|||It was analyzed by means of a logistic regression model adjusting by pre-defined baseline factors (treatment, gender, age class, baseline Schirmer I test value as fixed effects and site as random effect). For the imputation of missing data at week 4, a Multiple Imputation approach is adopted by performing a regression model with the baseline Schirmer I test value, gender, age class, and Schirmer I test at week 2 as explanatory variables and generating 200 datasets.||84.165|3.412|<0.001
74078927|NCT05133180|147711566|SUPERIORITY|The following null hypothesis is defined on this endpoint: the change from baseline (reduction) in the global SANDE score at week 12 in cenegermin is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|adjusted mean difference|-4.561||||0.322|TWO_SIDED|95.0|-13.581|4.459||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in the global SANDE score.|ANCOVA|||This endpoint was analyzed by means of an Analysis of Covariance with change from baseline in global SANDE Score at Week 12 as dependent variable, treatment, gender, age class, baseline global SANDE score as fixed effects and site as random effect. For missing data, Multiple Imputation approach is adopted by performing a regression model with the baseline global SANDE score, gender, age class, and intermediate global SANDE scores up to week 12 as explanatory variables and generating 200 datasets||4.459|-13.581|0.322
74078928|NCT05133180|147711567|SUPERIORITY|Analysis was based on a logistic regression with the number of patients reaching a value of Schirmer I test \>10mm/5min at week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.|Odds Ratio (OR)|15.95|||<|0.001|TWO_SIDED|95.0|3.091|82.31|||Regression, Logistic|||This key secondary endpoint was analyzed by means of a logistic regression model with the number of patients reaching a value of Schirmer I test \>10mm/5min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as fixed effects and site as random effect.||82.310|3.091|<0.001
74078929|NCT05133180|147711568|SUPERIORITY||adjusted mean difference|-2.753||||0.572|TWO_SIDED|95.0|-12.303|6.798||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for frequency at Week 12.|ANCOVA regression model|||This endpoint was analyzed by means of an ANCOVA adjusting by pre-defined baseline factors (treatment, gender, age class, baseline SANDE score for severity as fixed effects and site as random effect).||6.798|-12.303|0.572
74078930|NCT05133180|147711569|SUPERIORITY||adjusted mean difference|-4.732||||0.307|TWO_SIDED|95.0|-13.819|4.354||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for severity at Week 12.|ANCOVA regression model|||This endpoint was analyzed by means of an ANCOVA adjusting by pre-defined baseline factors (treatment, gender, age class, baseline SANDE score for severity as fixed effects and site as random effect).||4.354|-13.819|0.307
74078931|NCT05133180|147711570|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.16||||0.468|TWO_SIDED|95.0|-3.668|7.988||P-value of Least Square (LS) means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 4|MMRM|||Impact on daily activities at week 4.||7.988|-3.668|0.468
74078932|NCT05133180|147711570|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.431||||0.492|TWO_SIDED|95.0|-4.5|9.362||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Emotional Impact) at Week 4.|MMRM|||Emotional Impact due to Dry eye at week 4.||9.362|-4.500|0.492
74078933|NCT05133180|147711570|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM). Analyses included the fixed, categorical effects of treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall. Missing data will be imputed according to the questionnaire manuals"|LS means difference|3.3||||0.51|TWO_SIDED|95.0|-6.511|13.111||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Impact on Work) at Week 4.|MMRM|||Impact on Work due to Dry Eye at week 4.||13.111|-6.511|0.510
74078934|NCT05133180|147711570|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|Least square mean difference|4.078||||0.268|TWO_SIDED|95.0|-3.142|11.299||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 12.|MMRM|||Quality of life - Impact on daily activities - Week 12||11.299|-3.142|0.268
74078935|NCT05133180|147711570|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall"|least square mean difference|5.55||||0.227|TWO_SIDED|95.0|-3.462|14.562||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Emotional Impact) at Week 12.|MMRM|||Quality of life - Emotional Impact due to Dry eye - Week 12||14.562|-3.462|0.227
74078936|NCT05133180|147711570|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|3.475||||0.501|TWO_SIDED|95.0|-6.651|13.601||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Impact on Work) at Week 12.|MMRM|||Quality of life - Impact on Work due to Dry Eye - Week 12||13.601|-6.651|0.501
74078937|NCT05133180|147711571|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-0.549||||0.924|TWO_SIDED|95.0|-11.82|10.723||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 4.|MMRM|||IDEEL Treatment satisfaction \& Bother Module Satisfaction with Treatment Effectiveness - week 4||10.723|-11.820|0.924
74078938|NCT05133180|147711571|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|1.072||||0.745|TWO_SIDED|95.0|-5.398|7.542||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Treatment- Related Bother / Inconvenience) at Week 4.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Treatment- Related Bother / Inconvenience - week 4||7.542|-5.398|0.745
73886117|NCT03165617|147305932|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.72|||||TWO_SIDED|95.0|42.14|73.33||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||73.33|42.14|
73886118|NCT03165617|147305933|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.81|||||TWO_SIDED|95.0|51.3|68.46||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||68.46|51.3|
73886119|NCT03165617|147305933|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.78|||||TWO_SIDED|95.0|49.01|69.83||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||69.83|49.01|
73886120|NCT03165617|147305933|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|59.66|||||TWO_SIDED|95.0|49.08|68.05||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||68.05|49.08|
73886121|NCT03165617|147305933|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.72|||||TWO_SIDED|95.0|42.14|73.33||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||73.33|42.14|
73886122|NCT03165617|147305934|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|63.64|||||TWO_SIDED|95.0|53.64|71.48||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||71.48|53.64|
73886123|NCT03165617|147305934|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|63.04|||||TWO_SIDED|95.0|50.66|72.32||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||72.32|50.66|
73886124|NCT03165617|147305934|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|61.58|||||TWO_SIDED|95.0|50.25|70.53||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||70.53|50.25|
73886125|NCT03165617|147305934|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|64.78|||||TWO_SIDED|95.0|44.84|77.51||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||77.51|44.84|
73886126|NCT01710345|147305960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|4.45||0.742|ONE_SIDED|95.0|||||ANCOVA|||||||0.742
73886127|NCT01710345|147305960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.66|STANDARD_ERROR_OF_MEAN|4.47||0.003|ONE_SIDED|95.0|||||ANCOVA|||||||0.003
73886128|NCT00449696|147305987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.91||||0.122||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.122
73886129|NCT00449696|147305988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.42||||0.071||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.071
73886130|NCT00449696|147305989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.64||||0.058||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.058
73886131|NCT00449696|147305990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.022||95.0||||P-value for strict OMERACT-OARSI response.|Generalized Estimating Equation Model|||||||0.022
73886132|NCT00449696|147305990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.242||95.0||||P-value for OMERACT-OARSI response.|Generalized Estimating Equation Model|||||||0.242
73886133|NCT00449696|147305991|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||P-value for physical component scores, physical function subscale, role physical subscale, and bodily pain subscale.|Wilcoxon (Mann-Whitney)|||||||>0.05
73886134|NCT00449696|147305992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.39||||0.037||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.037
73888404|NCT02900378|147309621|OTHER|||||||0.2172|||||||Chi-squared|||Week 12||||0.2172
73888405|NCT02900378|147309622|OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0008
74078939|NCT05133180|147711571|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-4.206||||0.467|TWO_SIDED|95.0|-15.53|7.118||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 12.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Satisfaction with Treatment Effectiveness - week 12||7.118|-15.530|0.467
74078940|NCT05133180|147711571|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.244||||0.564|TWO_SIDED|95.0|-5.387|9.874||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Treatment- Related Bother / Inconvenience) at Week 12.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Treatment- Related Bother / Inconvenience - week 12||9.874|-5.387|0.564
74078941|NCT05133180|147711572|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-0.805||||0.802|TWO_SIDED|95.0|-7.086|5.476||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Symptom Bother Module at Week 4.|MMRM|||IDEEL - Symptom Bother module - week 4||5.476|-7.086|0.802
74078942|NCT05133180|147711572|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-8.789||||0.019|TWO_SIDED|95.0|-16.16|-1.418||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Symptom Bother Module at Week 12.|MMRM|||IDEEL - Symptom Bother module - week 12||-1.418|-16.160|0.019
74078943|NCT05133180|147711573|SUPERIORITY||least square mean difference|-1.518||||0.045|TWO_SIDED|95.0|-3.005|-0.031||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 4.|MMRM|||Herein Week 4 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||-0.031|-3.005|0.045
74078944|NCT05133180|147711573|SUPERIORITY||least square mean difference|-1.773||||0.038|TWO_SIDED|95.0|-3.446|-0.101||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 8.|MMRM|||Herein Week 8 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||-0.101|-3.446|0.038
74078945|NCT05133180|147711573|SUPERIORITY||least square mean difference|-1.224||||0.2|TWO_SIDED|95.0|-3.096|0.649||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 12|MMRM|||Herein Week 12 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||0.649|-3.096|0.200
74078946|NCT05133180|147711574|SUPERIORITY||least square mean difference|1.64||||0.016|TWO_SIDED|95.0|0.3|2.98||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 4.|MMRM|||Herein week 4 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.980|0.300|0.016
74078947|NCT05133180|147711574|SUPERIORITY||least ssquare mean difference|1.133||||0.129|TWO_SIDED|95.0|-0.329|2.596||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 8.|MMRM|||Herein week 8 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.596|-0.329|0.129
74078948|NCT05133180|147711574|SUPERIORITY||least square mean difference|1.36||||0.05|TWO_SIDED|95.0|-0.002|2.722||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 12.|MMRM|||Herein week 12 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.722|-0.002|0.050
74078949|NCT05133180|147711575|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 4 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||<0.001
73888406|NCT02900378|147309622|OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0008
74078950|NCT05133180|147711575|SUPERIORITY|||||||0.009||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.009
74078951|NCT05133180|147711575|SUPERIORITY|||||||0.02||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.020
74078952|NCT05133180|147711575|SUPERIORITY|||||||0.022||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.022
74078953|NCT05133180|147711576|SUPERIORITY|||||||0.065||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.065
74078954|NCT05133180|147711577|SUPERIORITY|||||||0.125||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.125
74078955|NCT05133180|147711578|SUPERIORITY|||||||0.005||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.005
74078956|NCT05133180|147711578|SUPERIORITY|||||||0.116||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.116
74078957|NCT05133180|147711578|SUPERIORITY|||||||0.864||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.864
74078958|NCT05133180|147711579|SUPERIORITY|||||||0.011||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.011
74078959|NCT05133180|147711579|SUPERIORITY|||||||0.316||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.316
74078960|NCT05133180|147711579|SUPERIORITY|||||||0.685||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.685
74078961|NCT05133180|147711580|SUPERIORITY|||||||0.016||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.016
74078962|NCT05133180|147711580|SUPERIORITY|||||||0.16||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.160
74078963|NCT05133180|147711580|SUPERIORITY|||||||0.839||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.839
74078964|NCT05133180|147711581|SUPERIORITY|||||||0.0455|||||||Chi-squared|||||||0.0455
73886135|NCT00449696|147305993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92||||0.746||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.746
73886136|NCT00449696|147305994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.166||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.166
73886137|NCT00449696|147305995|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.041
73886138|NCT01903460|147305996|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-40.707||||0.574|TWO_SIDED|95.0|-191.679|110.265|||ANCOVA|||Analysis of LUM001 140ug/kg/day||110.265|-191.679|0.5740
73886139|NCT01903460|147305996|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-7.231||||0.9147|TWO_SIDED|95.0|-148.726|134.264|||ANCOVA|||Analysis of LUM001 280ug/kg/day||134.264|-148.726|0.9147
73886140|NCT01903460|147305996|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-23.969||||0.6954|TWO_SIDED|95.0|-151.969|104.031|||ANCOVA|||Analysis of all doses of LUM001||104.031|-151.969|0.6954
74078965|NCT05133180|147711582|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.06||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on daily activities - Week 8||||0.060
73886141|NCT01903460|147305997|SUPERIORITY_OR_OTHER||LS mean difference from placebo|56.7||||0.0783|TWO_SIDED|95.0|-7.2|120.6|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALT||120.6|-7.2|0.0783
73886142|NCT01903460|147305997|SUPERIORITY_OR_OTHER||LS mean difference from placebo|7.8||||0.7827|TWO_SIDED|95.0|-51.4|67.0|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALT||67.0|-51.4|0.7827
73886143|NCT01903460|147305997|SUPERIORITY_OR_OTHER||LS mean difference from placebo|32.2||||0.2235|TWO_SIDED|95.0|-21.9|86.3|||ANCOVA|||Analysis of all doses of LUM001 for ALT||86.3|-21.9|0.2235
73886144|NCT01903460|147305997|SUPERIORITY_OR_OTHER||LS mean difference from placebo|24.0||||0.2372|TWO_SIDED|95.0|-17.5|65.5|||ANCOVA|||Analysis of LUM001 140ug/kg/day for AST||65.5|-17.5|0.2372
73886145|NCT01903460|147305997|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-15.8||||0.3914|TWO_SIDED|95.0|-54.1|22.4|||ANCOVA|||Analysis of LUM001 280ug/kg/day for AST||22.4|-54.1|0.3914
73886146|NCT01903460|147305997|SUPERIORITY_OR_OTHER||LS mean difference from placebo|4.1||||0.8081|TWO_SIDED|95.0|-31.0|39.1|||ANCOVA|||Analysis of all doses of LUM001 for AST||39.1|-31.0|0.8081
73886147|NCT01903460|147305997|SUPERIORITY_OR_OTHER||LS mean difference from placebo|51.7||||0.5748|TWO_SIDED|95.0|-140.3|243.7|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALP||243.7|-140.3|0.5748
73886148|NCT01903460|147305997|SUPERIORITY_OR_OTHER||LS mean difference from placebo|11.9||||0.8835|TWO_SIDED|95.0|-158.4|182.2|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALP||182.2|-158.4|0.8835
73886149|NCT01903460|147305997|SUPERIORITY_OR_OTHER||LS mean difference from placebo|31.8||||0.6917|TWO_SIDED|95.0|-135.8|199.4|||ANCOVA|||Analysis of all doses of LUM001 for ALP||199.4|-135.8|0.6917
73886150|NCT01903460|147305998|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.348||||0.6907|TWO_SIDED|95.0|-2.468|1.772|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Patient ItchRO||1.772|-2.468|0.6907
73886151|NCT01903460|147305998|SUPERIORITY_OR_OTHER||LS mean difference from placebo|0.202||||0.7897|TWO_SIDED|95.0|-1.647|2.052|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Patient ItchRO||2.052|-1.647|0.7897
73886152|NCT01903460|147305998|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.073||||0.9203|TWO_SIDED|95.0|-1.85|1.705|||ANCOVA|||Analysis of all doses of LUM001 for Patient ItchRO||1.705|-1.850|0.9203
73886153|NCT01903460|147305998|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.21||||0.5966|TWO_SIDED|95.0|-1.038|0.618|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Observer ItchRO||0.618|-1.038|0.5966
73886154|NCT01903460|147305998|SUPERIORITY_OR_OTHER||LS mean difference from placebo|0.173||||0.632|TWO_SIDED|95.0|-0.58|0.926|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Observer ItchRO||0.926|-0.580|0.6320
74078966|NCT05133180|147711582|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.079||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Emotional impact due to Dry eye - Week 8||||0.079
74078967|NCT05133180|147711582|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.251||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Quality of life - Impact on work due to Dry Eye - Week 8||||0.251
74078968|NCT05133180|147711582|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.203||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on daily activities - Week 16||||0.203
74078969|NCT05133180|147711582|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.114||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Emotional impact due to Dry eye - Week 16||||0.114
74078970|NCT05133180|147711582|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.112||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on work due to Dry Eye - Week 16||||0.112
74078971|NCT05133180|147711583|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.002||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Symptom bother module - Week 8||||0.002
74078972|NCT05133180|147711583|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.076||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Symptom bother module - Week 16||||0.076
74078973|NCT05133180|147711584|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.16||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||IDEEL - Satisfaction with Treatment Effectiveness - Week 8||||0.160
74078974|NCT05133180|147711584|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.009||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||IDEEL - Treatment- Related Bother / Inconvenience - Week 8||||0.009
74078975|NCT05133180|147711584|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.076||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||IDEEL - Satisfaction with Treatment Effectiveness - Week 16||||0.076
74078976|NCT05133180|147711584|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.128||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||IDEEL - Treatment- Related Bother / Inconvenience - Week 16||||0.128
74078977|NCT00862563|147711616|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.1|STANDARD_ERROR_OF_MEAN|1.1||0.06|TWO_SIDED|||||p\<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least means squares from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.06
74078978|NCT00862563|147711616|SUPERIORITY_OR_OTHER||Difference between least squares means|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.008|TWO_SIDED|||||p\< 0.05 was considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.008
74078979|NCT00862563|147711616|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.1|STANDARD_ERROR_OF_MEAN|1.2||0.07|TWO_SIDED|||||p\< 0.05 was considered to be significant.|Mixed Models Analysis|||Comparison of Week 12 mean for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.07
74078980|NCT00862563|147711616|SUPERIORITY_OR_OTHER||Difference between least squares means.|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.003|TWO_SIDED|||||p\<0.05 is considered as being significant.|ANOVA|||Comparison of Week 10 mean for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates,||||0.003
74078981|NCT00862563|147711616|SUPERIORITY_OR_OTHER||Difference between least squares means|-4.4|STANDARD_ERROR_OF_MEAN|1.1||0.0002|TWO_SIDED||||||ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. .||||0.0002
74078982|NCT00862563|147711616|SUPERIORITY_OR_OTHER||Difference between least squares means|-4.1|STANDARD_ERROR_OF_MEAN|1.2||0.0007|TWO_SIDED||||||ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0007
74078983|NCT00862563|147711616|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.64|STANDARD_ERROR_OF_MEAN|1.1||0.15|TWO_SIDED|||||p\<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.15
74078984|NCT00862563|147711616|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.9|STANDARD_ERROR_OF_MEAN|1.2||0.014|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariate values.||||0.014
74078985|NCT00862563|147711616|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.0|STANDARD_ERROR_OF_MEAN|1.2||0.1|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means s from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.1
74078986|NCT00862563|147711617|SUPERIORITY_OR_OTHER||Mean difference Week 12|8.9|STANDARD_ERROR_OF_MEAN|3.6||0.015|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison between mean values obtained for the topiramate and placebo groups for Week 12. Model generated least mean squares were used for this analysis.||||0.015
74078987|NCT00862563|147711617|SUPERIORITY_OR_OTHER||Mean Difference Week 12|0.98|STANDARD_ERROR_OF_MEAN|3.6||0.784|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the zonisamide and placebo group for Week 12. Mixed models generated means were used in this analysis.||||0.784
74078988|NCT00862563|147711617|SUPERIORITY_OR_OTHER||Mean difference Week 12|3.65|STANDARD_ERROR_OF_MEAN|3.3||0.264|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the levetiracetam and placebo groups for Week 12. Model generated least mean squares were used for this analysis.||||0.264
73886155|NCT01903460|147305998|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.019||||0.9547|TWO_SIDED|95.0|-0.71|0.673|||ANCOVA|||Analysis of all doses of LUM001 for Observer ItchRO||0.673|-0.710|0.9547
73886156|NCT04973449|147306002|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.08|1.32||||||The analyses were derived using analysis of covariance (ANCOVA).||1.32|1.08|
73886157|NCT04973449|147306003|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.14||||||The analyses were derived using ANCOVA.||1.14|0.90|
73886158|NCT04973449|147306004|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|1.68|||||TWO_SIDED|95.0|-3.11|6.49||||||The analyses were derived using ANCOVA.||6.49|-3.11|
73886159|NCT04973449|147306005|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|3.47|||||TWO_SIDED|95.0|3.09|3.89||||||The analyses were derived using ANCOVA.||3.89|3.09|
73886160|NCT04973449|147306008|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|3.21|||||TWO_SIDED|95.0|3.06|3.36||||||The analyses were derived using ANCOVA.||3.36|3.06|
73886161|NCT04973449|147306009|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.5|||||TWO_SIDED|95.0|0.45|0.56||||||The analyses were derived using ANCOVA.||0.56|0.45|
73886162|NCT04973449|147306010|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.31|||||TWO_SIDED|95.0|0.27|0.35||||||The analyses were derived using ANCOVA.||0.35|0.27|
73886163|NCT04973449|147306011|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.41|||||TWO_SIDED|95.0|1.25|1.58||||||The analyses were derived using ANCOVA.||1.58|1.25|
73886164|NCT04973449|147306012|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.84|||||TWO_SIDED|95.0|1.63|2.08||||||The analyses were derived using ANCOVA.||2.08|1.63|
73886165|NCT04973449|147306013|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.88|||||TWO_SIDED|95.0|0.78|0.99||||||The analyses were derived using ANCOVA.||0.99|0.78|
73886166|NCT04973449|147306014|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.87|||||TWO_SIDED|95.0|0.78|0.97||||||The analyses were derived using ANCOVA.||0.97|0.78|
73886167|NCT04973449|147306015|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.95|||||TWO_SIDED|95.0|0.83|1.08||||||The analyses were derived using ANCOVA.||1.08|0.83|
73886168|NCT04973449|147306016|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|6.56|||||TWO_SIDED|95.0|5.82|7.4||||||The analyses were derived using ANCOVA.||7.40|5.82|
73886169|NCT04973449|147306017|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.22|||||TWO_SIDED|95.0|1.99|2.47||||||The analyses were derived using ANCOVA.||2.47|1.99|
73886170|NCT04973449|147306018|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|4.35|||||TWO_SIDED|95.0|3.86|4.9||||||The analyses were derived using ANCOVA.||4.90|3.86|
73886171|NCT04973449|147306019|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.25|||||TWO_SIDED|95.0|1.13|1.39||||||The analyses were derived using ANCOVA.||1.39|1.13|
73886172|NCT04973449|147306020|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|4.42|||||TWO_SIDED|95.0|3.85|5.08||||||The analyses were derived using ANCOVA.||5.08|3.85|
73886173|NCT04973449|147306021|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-1.24|||||TWO_SIDED|95.0|-6.62|3.84||||||The analyses were derived using ANCOVA.||3.84|-6.62|
73888407|NCT02900378|147309622|OTHER|||||||0.0297|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0297
73886174|NCT04973449|147306022|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|16.86|||||TWO_SIDED|95.0|10.18|23.32||||||The analyses were derived using ANCOVA.||23.32|10.18|
73886175|NCT04973449|147306023|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.12|||||TWO_SIDED|95.0|-24.22|-12.07||||||The analyses were derived using ANCOVA.||-12.07|-24.22|
73886176|NCT04973449|147306024|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-0.02|||||TWO_SIDED|95.0|-7.28|7.23||||||The analyses were derived using ANCOVA.||7.23|-7.28|
73886177|NCT04973449|147306025|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|31.36|||||TWO_SIDED|95.0|24.44|37.82||||||The analyses were derived using ANCOVA.||37.82|24.44|
73886178|NCT04973449|147306026|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-3.55|||||TWO_SIDED|95.0|-9.4|1.9||||||The analyses were derived using ANCOVA.||1.90|-9.40|
73886179|NCT04973449|147306027|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|23.01|||||TWO_SIDED|95.0|15.41|30.23||||||The analyses were derived using ANCOVA.||30.23|15.41|
73886180|NCT04973449|147306028|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-34.24|||||TWO_SIDED|95.0|-40.77|-27.45||||||The analyses were derived using ANCOVA.||-27.45|-40.77|
74078989|NCT00862563|147711618|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.4|STANDARD_ERROR_OF_MEAN|9.7||0.013|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.013
74078990|NCT00862563|147711618|SUPERIORITY_OR_OTHER||Difference between least squares means|-20.9|STANDARD_ERROR_OF_MEAN|9.8||0.036|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.036
73886181|NCT04973449|147306029|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|6.96|||||TWO_SIDED|95.0|-1.31|15.1||||||The analyses were derived using ANCOVA.||15.10|-1.31|
73886182|NCT04973449|147306030|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|29.05|||||TWO_SIDED|95.0|21.76|35.81||||||The analyses were derived using ANCOVA.||35.81|21.76|
73886183|NCT04973449|147306032|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.3|1.42||||||The analyses were derived using ANCOVA.||1.42|1.30|
73886184|NCT04973449|147306033|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.76|||||TWO_SIDED|95.0|0.7|0.81||||||The analyses were derived using ANCOVA.||0.81|0.70|
73886185|NCT04973449|147306034|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|3.87|||||TWO_SIDED|95.0|3.4|4.39||||||The analyses were derived using ANCOVA.||4.39|3.40|
73886186|NCT04973449|147306035|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.67|||||TWO_SIDED|95.0|0.64|0.7||||||The analyses were derived using ANCOVA.||0.70|0.64|
73886187|NCT04973449|147306036|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.58|||||TWO_SIDED|95.0|-0.61|2.09||||||The analyses were derived using ANCOVA.||2.09|-0.61|
73886188|NCT04973449|147306037|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-35.18|||||TWO_SIDED|95.0|-41.46|-28.44||||||The analyses were derived using ANCOVA.||-28.44|-41.46|
73886189|NCT04973449|147306038|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-24.93|||||TWO_SIDED|95.0|-31.06|-18.56||||||The analyses were derived using ANCOVA.||-18.56|-31.06|
74078991|NCT00862563|147711618|SUPERIORITY_OR_OTHER||Difference between least squares means|-22.8|STANDARD_ERROR_OF_MEAN|9.9||0.24|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.24
73886190|NCT04973449|147306039|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-0.02|||||TWO_SIDED|95.0|-1.63|1.56||||||The analyses were derived using ANCOVA.||1.56|-1.63|
73886191|NCT04973449|147306040|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-19.18|||||TWO_SIDED|95.0|-23.8|-14.98||||||The analyses were derived using ANCOVA.||-14.98|-23.80|
73886192|NCT04973449|147306041|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|39.18|||||TWO_SIDED|95.0|32.68|45.21||||||The analyses were derived using ANCOVA.||45.21|32.68|
73886193|NCT04973449|147306042|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.0|||||TWO_SIDED|95.0|-1.62|1.62||||||The analyses were derived using ANCOVA.||1.62|-1.62|
74078992|NCT00862563|147711618|SUPERIORITY_OR_OTHER||Difference between least squares means|-33.0|STANDARD_ERROR_OF_MEAN|9.0||0.0004|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0004
73886194|NCT04973449|147306043|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.52|||||TWO_SIDED|95.0|0.45|0.59||||||The analyses were derived using ANCOVA.||0.59|0.45|
73886195|NCT04973449|147306044|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.76|||||TWO_SIDED|95.0|0.68|0.86||||||The analyses were derived using ANCOVA.||0.86|0.68|
73886196|NCT04973449|147306045|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.6|||||TWO_SIDED|95.0|1.43|1.79||||||The analyses were derived using ANCOVA.||1.79|1.43|
73886197|NCT04973449|147306046|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.75|||||TWO_SIDED|95.0|0.67|0.85||||||The analyses were derived using ANCOVA.||0.85|0.67|
73886198|NCT04973449|147306047|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.1|||||TWO_SIDED|95.0|-24.13|-12.1||||||The analyses were derived using ANCOVA.||-12.10|-24.13|
73886199|NCT04973449|147306048|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|14.5|||||TWO_SIDED|95.0|7.07|21.71||||||The analyses were derived using ANCOVA.||21.71|7.07|
73886200|NCT04973449|147306049|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.1|||||TWO_SIDED|95.0|-24.13|-12.1||||||The analyses were derived using ANCOVA.||-12.10|-24.13|
73886201|NCT04973449|147306050|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|16.87|||||TWO_SIDED|95.0|10.15|23.4||||||The analyses were derived using ANCOVA.||23.40|10.15|
73886202|NCT04973449|147306051|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.0|||||TWO_SIDED|95.0|-7.21|7.21||||||The analyses were derived using ANCOVA.||7.21|-7.21|
74078993|NCT00862563|147711618|SUPERIORITY_OR_OTHER||Difference between least squares means|-29.7|STANDARD_ERROR_OF_MEAN|9.2||0.0015|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0015
73886203|NCT04973449|147306052|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.0|||||TWO_SIDED|95.0|1.75|2.28||||||The analyses were derived using ANCOVA.||2.28|1.75|
74078994|NCT00862563|147711618|SUPERIORITY_OR_OTHER||Difference between least squares means|-37.7|STANDARD_ERROR_OF_MEAN|9.3|<|0.0001|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||<0.0001
74078995|NCT00862563|147711618|SUPERIORITY_OR_OTHER||Difference between least squares means|-20.7|STANDARD_ERROR_OF_MEAN|10.0||0.04|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.04
74078996|NCT00862563|147711618|SUPERIORITY_OR_OTHER||Difference between least squares means|-23.3|STANDARD_ERROR_OF_MEAN|10.2||0.025|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.025
73886204|NCT04973449|147306053|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.96|||||TWO_SIDED|95.0|2.64|3.32||||||The analyses were derived using ANCOVA.||3.32|2.64|
74078997|NCT00862563|147711618|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.8|STANDARD_ERROR_OF_MEAN|10.3||0.018|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.018
73886205|NCT04973449|147306054|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.51|||||TWO_SIDED|95.0|1.35|1.69||||||The analyses were derived using ANCOVA.||1.69|1.35|
73886206|NCT04973449|147306055|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.85|||||TWO_SIDED|95.0|0.78|0.94||||||The analyses were derived using ANCOVA.||0.94|0.78|
73886207|NCT04973449|147306056|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-41.2|||||TWO_SIDED|95.0|-47.57|-34.41||||||The analyses were derived using ANCOVA.||-34.41|-47.57|
74078998|NCT00862563|147711619|SUPERIORITY_OR_OTHER||Difference between least squares means|-22.5|STANDARD_ERROR_OF_MEAN|7.8||0.005|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.005
74078999|NCT00862563|147711619|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.1|STANDARD_ERROR_OF_MEAN|7.9||0.003|TWO_SIDED||||||ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.003
74079000|NCT00862563|147711619|SUPERIORITY_OR_OTHER||Difference between least square means|-16.3|STANDARD_ERROR_OF_MEAN|8.0||0.044|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.044
73886208|NCT04973449|147306057|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|6.05|||||TWO_SIDED|95.0|-1.81|13.77||||||The analyses were derived using ANCOVA.||13.77|-1.81|
73886209|NCT04973449|147306058|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-26.56|||||TWO_SIDED|95.0|-33.1|-19.94||||||The analyses were derived using ANCOVA.||-19.94|-33.10|
74079001|NCT00862563|147711619|SUPERIORITY_OR_OTHER||Difference between least squares means|-38.1|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factors. Baseline values were used as covariates.||||<0.0001
74079002|NCT00862563|147711619|SUPERIORITY_OR_OTHER||Difference between least squares means|-47.6|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||<0.0001
74079003|NCT00862563|147711619|SUPERIORITY_OR_OTHER||Difference between least squares means|-34.0|STANDARD_ERROR_OF_MEAN|9.2||0.0004|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Week 12.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0004
74079004|NCT00862563|147711619|SUPERIORITY_OR_OTHER||Difference between least squares means|-19.3|STANDARD_DEVIATION|8.0||0.017|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.||||0.017
74079005|NCT00862563|147711619|SUPERIORITY_OR_OTHER||Difference between least squares means|-31.2|STANDARD_ERROR_OF_MEAN|8.1||0.0002|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.||||0.0002
74079006|NCT00862563|147711619|SUPERIORITY_OR_OTHER||Difference between least squares means|-18.5|STANDARD_ERROR_OF_MEAN|8.2||0.026|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis.Baseline values were used as covariates.||||0.026
74079007|NCT00862563|147711620|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\< 0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction term.'||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||<0.0001
74079008|NCT00862563|147711620|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value is for group x time interaction term for the comparison of data for the topiramate and placebo group.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in a significant treatment x time interaction.||||<0.0001
74079009|NCT00862563|147711620|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value is for interaction effect for the comparison of data for the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in a significant treatment x time interaction.||||0.30
73886210|NCT04973449|147306059|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|30.69|||||TWO_SIDED|95.0|22.94|37.9||||||The analyses were derived using ANCOVA.||37.90|22.94|
74079010|NCT00862563|147711621|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction effect for the paired comparison of COWAT-category data for the zonisamide and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.003
74079011|NCT00862563|147711621|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||p\< 0.01 is considered to be significant.|Mixed Models Analysis|The p value shown is for the group x time interaction effect for the comparison of data from the topiramate and the placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction||||0.01
73888408|NCT02900378|147309622|OTHER|||||||0.0069|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0069
74079012|NCT00862563|147711621|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|The p value is for the group x time interaction effect for the comparison of the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction||||0.36
74079013|NCT00862563|147711622|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value is for the group x time interaction effect||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.07
74079014|NCT00862563|147711622|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group X time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that age adjusted Digit Span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.||||<0.0001
74079015|NCT00862563|147711622|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.||||0.95
74079016|NCT00862563|147711623|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Spatial Span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.038
74079017|NCT00862563|147711623|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.||||0.0025
74079018|NCT00862563|147711623|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.||||0.3
74079019|NCT00395694|147711628|SUPERIORITY_OR_OTHER||Percentage of participants|4.9|||||TWO_SIDED|95.0|1.6|11.1|||||The estimated value represents the percentage of participants with rash events.|||11.1|1.6|
74079020|NCT00840216|147711640|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|106.9||||||90.0|||||||Bioequivalence is established when the ratio of the mean falls within 80-125.|||||
74079021|NCT00840216|147711641|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.|||||
74079022|NCT00840216|147711642|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.|||||
74079023|NCT01058668|147711643|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-8.4|-3.8|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo|||-3.8|-8.4|<0.001
74079024|NCT01058668|147711643|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.9|||<|0.001|TWO_SIDED|95.0|-8.2|-3.6|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo|||-3.6|-8.2|<0.001
74079025|NCT01058668|147711644|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.4|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo|||-0.4|-0.9|<0.001
74079026|NCT01058668|147711644|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo|||-0.3|-0.9|<0.001
74079027|NCT04859517|147711645|SUPERIORITY||Risk Difference (RD)|-5.0||||0.0123|TWO_SIDED|95.0|-8.87|-1.08|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-1.08|-8.87|0.0123
74079028|NCT04859517|147711646|SUPERIORITY||Risk Difference (RD)|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.75|-2.01|||Regression, Logistic|||||-2.01|-5.75|<0.0001
74079029|NCT04859517|147711649|SUPERIORITY||Standardized Risk Difference|-7.6||||0.0153|TWO_SIDED|95.0|-13.74|-1.46|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-1.46|-13.74|0.0153
74079030|NCT04859517|147711650|SUPERIORITY||Risk Difference (RD)|-4.4||||0.0612|TWO_SIDED|95.0|-9.03|0.21|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|0.21|-9.03|0.0612
74079031|NCT04859517|147711669|SUPERIORITY||Hazard Ratio (HR)|0.22||||0.0077|TWO_SIDED|95.0|0.06|0.76|||Log Rank|||||0.76|0.06|0.0077
74079032|NCT04859517|147711670|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.14|0.49|||Log Rank|||||0.49|0.14|<0.0001
74079033|NCT02284867|147711714|NON_INFERIORITY_OR_EQUIVALENCE|"Multivariable binary logistic regression was done to examine the relation between CD16+ NK and preterm labor as adjusted for other confounding factors the enter method was used to build the regression model.~A two-sided p-value \<0.05 was considered statistically significant."|Odds Ratio (OR)|65.01|STANDARD_ERROR_OF_MEAN|1.14|<|0.0002|TWO_SIDED|95.0|6.96|606.76||To our best of known , no previous human studies was analyzing this issue|Regression, Logistic|||"Categorical data were presented as number and percentage and differences were compared using the Pearson chi-squared test. Ordinal data were compared using the chi-squared test for trend~A two-sided p-value \<0.05 was considered statistically significant."||606.76|6.96|<0.0002
73886211|NCT04973449|147306060|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|14.64|||||TWO_SIDED|95.0|6.36|22.64||||||The analyses were derived using ANCOVA.||22.64|6.36|
73886212|NCT04973449|147306061|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||The analyses were derived using analysis of covariance (ANCOVA).||0.96|0.74|
73886213|NCT04973449|147306062|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.71|||||TWO_SIDED|95.0|1.62|1.8||||||The analyses were derived using ANCOVA.||1.80|1.62|
73886214|NCT04973449|147306063|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.5|||||TWO_SIDED|95.0|0.44|0.56||||||The analyses were derived using ANCOVA.||0.56|0.44|
73886215|NCT04973449|147306064|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.38|||||TWO_SIDED|95.0|0.32|0.44||||||The analyses were derived using ANCOVA.||0.44|0.32|
73886216|NCT05810740|147306225|OTHER||LS-Mean Ratio, Percent|96.43|||||TWO_SIDED|90.0|92.57|100.46||||||||100.46|92.57|
73886217|NCT05810740|147306226|OTHER||Geometric Mean Ratio|97.19|||||TWO_SIDED|90.0|93.47|101.06||||||||101.06|93.47|
73886218|NCT05810740|147306227|OTHER||Geometric Mean Ratio|94.02|||||TWO_SIDED|90.0|87.25|101.33||||||||101.33|87.25|
73886219|NCT05737069|147306251|EQUIVALENCE|The two products were considered to be bioequivalent if 90 percent (%) confidence intervals (CIs) for the geometric mean ratio (GMR) (Test/Reference) for AUC(0-t) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|1.0008|||||TWO_SIDED|90.0|0.9698|1.0327||||||||1.0327|0.9698|
74079034|NCT02927639|147711716|SUPERIORITY|"A subject was considered completed if they completed all 3 SCI (as indicated in participant flow section) - 13 control, 10 intervention.~However, the mixed model took in to account ALL available data. As such, there were 70 control, 65 intervention that completed at least 1 SCI. Their data was analyzed by the model and used to predict later outcomes so they were considered to be included in the analysis."||||||0.035||||||The mixed model may provide a significantly different change in SCI score from baseline to the 6 month using a per-protocol analysis in the intervention group as compared to the control group. A p value \<0.05 was considered significant.|Mixed Models Analysis|||A multilevel mixed effects linear regression model was used to analyze this data. This analysis allowed for an estimation of missing data. This explains the discrepancy in the number of participant study completion vs participant data analyzed (see below).||||0.035
74079035|NCT01604941|147711726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.296|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.2960
74079036|NCT01604941|147711726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0400
74079037|NCT01604941|147711726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6303|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.6303
73886220|NCT05737069|147306252|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC (0-inf) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|1.0023|||||TWO_SIDED|90.0|0.971|1.0346||||||||1.0346|0.9710|
73886221|NCT05737069|147306253|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for Cmax were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9825|||||TWO_SIDED|90.0|0.9383|1.0288||||||||1.0288|0.9383|
73886222|NCT05737069|147306254|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC(0-t) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9916|||||TWO_SIDED|90.0|0.9755|1.0081||||||||1.0081|0.9755|
73886223|NCT05737069|147306255|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC (0-inf) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9776|||||TWO_SIDED|90.0|0.9432|1.0133||||||||1.0133|0.9432|
73886224|NCT05737069|147306256|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for Cmax were contained within the interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9982|||||TWO_SIDED|90.0|0.9431|1.0567||||||||1.0567|0.9431|
73886225|NCT04050553|147306277|SUPERIORITY||Least Square (LS) Mean Difference|-0.49||||0.7556|TWO_SIDED|95.0|-3.64|2.67|||Mixed Models Analysis|||||2.67|-3.64|0.7556
73886226|NCT04050553|147306278|SUPERIORITY||LS Mean Difference|-174.77||||0.0043|TWO_SIDED|95.0|-290.34|-59.21|||Mixed Models Analysis|||||-59.21|-290.34|0.0043
73886227|NCT04050553|147306279|SUPERIORITY||LS Mean Difference|-488.31|||<|0.0001|TWO_SIDED|95.0|-621.25|-355.36|||Mixed Models Analysis|||||-355.36|-621.25|<0.0001
73886228|NCT04050553|147306280|SUPERIORITY||LS Mean Difference|4.39||||0.0023|TWO_SIDED|95.0|1.69|7.08|||Mixed Models Analysis|||||7.08|1.69|0.0023
73886229|NCT04050553|147306281|SUPERIORITY||LS Mean Difference|-0.06||||0.0505|TWO_SIDED|95.0|-0.13|0.0|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 100 mg/dL.||0.00|-0.13|0.0505
73886230|NCT04050553|147306281|SUPERIORITY||LS Mean Difference|-0.18||||0.0104|TWO_SIDED|95.0|-0.31|-0.05|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 63 mg/dL.||-0.05|-0.31|0.0104
73886231|NCT04050553|147306281|SUPERIORITY||LS Mean Difference|-0.19||||0.0068|TWO_SIDED|95.0|-0.32|-0.06|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 45 mg/dL.||-0.06|-0.32|0.0068
73886232|NCT04050553|147306281|SUPERIORITY||LS Mean Difference|-0.11||||0.2302|TWO_SIDED|95.0|-0.3|0.08|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 72 mg/dL.||0.08|-0.30|0.2302
73886233|NCT04050553|147306282|SUPERIORITY||LS Mean Difference|-0.51||||0.8298|TWO_SIDED|95.0|-5.28|4.27|||Mixed Models Analysis|||For systolic blood pressure.||4.27|-5.28|0.8298
73886234|NCT04050553|147306282|SUPERIORITY||LS Mean Difference|1.96||||0.1516|TWO_SIDED|95.0|-0.76|4.67|||Mixed Models Analysis|||For diastolic blood pressure.||4.67|-0.76|0.1516
74079038|NCT01604941|147711727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0365|TWO_SIDED|||||P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.0365
74079039|NCT01604941|147711727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0019
74079040|NCT01604941|147711727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1695|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.1695
74079041|NCT01604941|147711728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.0394
74079042|NCT01604941|147711728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0004
74079043|NCT01604941|147711728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0332|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.0332
74079044|NCT01604941|147711729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3202|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.3202
74079045|NCT01604941|147711729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4549|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.4549
74079046|NCT01604941|147711729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3291|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.3291
74079047|NCT01604941|147711730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6703|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for 50 mg/kg/d dosing||||0.6703
74079048|NCT01604941|147711730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2618|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for all participants with BID dosing||||0.2618
74079049|NCT01604941|147711730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7679|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 16 for all participants with BID dosing||||0.7679
74079050|NCT01604941|147711731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1683|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.1683
73886235|NCT04050553|147306283|SUPERIORITY||LS Mean Difference|-0.89||||0.5776|TWO_SIDED|95.0|-4.1|2.33|||Mixed Models Analysis|||||2.33|-4.10|0.5776
73886236|NCT02153632|147306291|SUPERIORITY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|1.75||0.031|TWO_SIDED|95.0|-10.5|-0.5|||ANCOVA|||||-0.5|-10.5|0.031
73886237|NCT02153632|147306291|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|1.71||0.011|TWO_SIDED|95.0|-11.5|-1.5|||ANCOVA|||||-1.5|-11.5|0.011
74079051|NCT01604941|147711731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0123|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0123
74079052|NCT01604941|147711731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2334|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.2334
74079053|NCT03930732|147711737|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and a few secondary endpoint analyses at a 2-sided significance level of 0.049. Testing was then performed sequentially in the order the endpoints are reported (till OM 9). The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.049 level.|Risk Difference (RD)|-0.324||||0.0005|TWO_SIDED|95.0|-0.508|-0.14|||Negative binomial model||Derived using delta method.|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), inhaled corticosteroid (ICS) dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.140|-0.508|0.0005
74079054|NCT03930732|147711738|SUPERIORITY||Least Square (LS) Mean Difference|0.083|||<|0.0001|TWO_SIDED|95.0|0.042|0.125||Threshold for significance at 0.049 level.|MMRM model|||Derived from mixed-effect model with repeated measures (MMRM) model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.125|0.042|<0.0001
73886238|NCT01084655|147306372|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square(LS)Means|1.204|||||TWO_SIDED|90.0|0.87|1.666||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.666|0.870|
74079055|NCT03930732|147711739|SUPERIORITY||LS Mean Difference|0.083||||0.0003|TWO_SIDED|95.0|0.038|0.128||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BDFEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.128|0.038|0.0003
74079056|NCT03930732|147711740|SUPERIORITY||LS Mean Difference|0.124||||0.0022|TWO_SIDED|95.0|0.045|0.203||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.203|0.045|0.0022
74079057|NCT03930732|147711741|SUPERIORITY||LS Mean Difference|0.127||||0.0034|TWO_SIDED|95.0|0.042|0.212||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.212|0.042|0.0034
74079058|NCT03930732|147711742|SUPERIORITY||LS Mean Difference|-3.363||||0.0017|TWO_SIDED|95.0|-5.459|-1.266||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in SGRQ total score up to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, treatment-by-visit interaction, baseline SGRQ total score, and SGRQ baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.266|-5.459|0.0017
74079059|NCT03930732|147711743|SUPERIORITY||Odds Ratio (OR)|1.439||||0.0089|TWO_SIDED|95.0|1.096|1.89||Threshold for significance at 0.049 level.|Regression, Logistic|||Derived from logistic regression model which includes treatment group, region (pooled country), ICS dose, smoking status at screening, and baseline SGRQ total score as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.890|1.096|0.0089
74079060|NCT03930732|147711744|SUPERIORITY||LS Mean Difference|-1.137||||0.0012|TWO_SIDED|95.0|-1.823|-0.45||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in E-RS: COPD RS-Total Score to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline E-RS: COPD RS-Total Score, and baseline E-RS: COPD RS-Total Score-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.450|-1.823|0.0012
74079061|NCT03930732|147711745|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|Risk Difference (RD)|-0.418||||0.0052|TWO_SIDED|95.0|-0.728|-0.109||Threshold for significance at 0.049 level.|Negative binomial model||Derived using delta method.|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), ICS dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.109|-0.728|0.0052
74079062|NCT04708028|147711762|SUPERIORITY|||||||0.379|||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.379
74079063|NCT04708028|147711762|SUPERIORITY|||||||0.646|||||||Wilcoxon (Mann-Whitney)|||8 minutes Post intervention (Dog exposure or no dog exposure)||||0.646
74079064|NCT04708028|147711762|SUPERIORITY|||||||0.219|||||||Wilcoxon (Mann-Whitney)|||8 minutes after starting dental procedure||||0.219
74079065|NCT04708028|147711762|SUPERIORITY|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||8 minutes after completion of dental procedure||||0.223
74079066|NCT04708028|147711763|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.410
74079067|NCT04708028|147711763|SUPERIORITY|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||8 minutes Post intervention (Dog exposure or no dog exposure)||||0.127
74079068|NCT04708028|147711763|SUPERIORITY|||||||0.268|||||||Wilcoxon (Mann-Whitney)|||8 minutes after starting dental procedure||||0.268
74079069|NCT04708028|147711763|SUPERIORITY|||||||0.353|||||||Wilcoxon (Mann-Whitney)|||8 minutes after completion of dental procedure||||0.353
73886239|NCT01084655|147306373|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.074|||||TWO_SIDED|90.0|0.793|1.455||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.455|0.793|
74079070|NCT02450539|147711766|SUPERIORITY||Hazard Ratio (HR)|1.765||||0.0068|TWO_SIDED|95.0|1.165|2.672|||Stratified log-rank test.||Stratified Cox proportional hazard model|Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).||2.672|1.165|0.0068
74079071|NCT02450539|147711769|SUPERIORITY||Hazard Ratio (HR)|1.333||||0.1746|TWO_SIDED|95.0|0.879|2.022|||Stratified log-rank test||Stratified Cox proportional hazard model|Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).\]||2.022|0.879|0.1746
74079072|NCT02450539|147711770|SUPERIORITY||Rate Difference|-17.9|||||TWO_SIDED|95.0|-29.3|-6.6|||||Confidence intervals are based on the normal approximation to the binomial.|||-6.6|-29.3|
74079073|NCT02450539|147711771|SUPERIORITY||Rate Difference|-13.2|||||TWO_SIDED|95.0|-29.2|2.8|||||Confidence intervals are based on the normal approximation to the binomial.|||2.8|-29.2|
73886240|NCT01084655|147306376|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.066|||||TWO_SIDED|90.0|0.802|1.417||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.417|0.802|
73886241|NCT01084655|147306377|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.068|||||TWO_SIDED|90.0|0.955|1.195||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.195|0.955|
73886242|NCT05024032|147306398|SUPERIORITY||LS Mean Difference|-12.0|||<|0.001|TWO_SIDED|95.0|-14.8|-9.3|||Mixed Models Analysis|||||-9.3|-14.8|<0.001
73886243|NCT05024032|147306398|SUPERIORITY||LS Mean Difference|-17.5|||<|0.001|TWO_SIDED|95.0|-20.3|-14.8|||Mixed Models Analysis|||||-14.8|-20.3|<0.001
73886244|NCT05024032|147306399|SUPERIORITY||Odds Ratio (OR)|23.11|||<|0.001|TWO_SIDED|95.0|8.8|60.69|||Regression, Logistic|||||60.69|8.80|<0.001
73886245|NCT05024032|147306399|SUPERIORITY||Odds Ratio (OR)|26.53|||<|0.001|TWO_SIDED|95.0|9.61|73.24|||Regression, Logistic|||||73.24|9.61|<0.001
73886246|NCT05024032|147306400|SUPERIORITY||LS Mean Difference|-7.2|||<|0.001|TWO_SIDED|95.0|-8.8|-5.5|||Mixed Models Analysis|||||-5.5|-8.8|<0.001
73886247|NCT05024032|147306400|SUPERIORITY||LS Mean Difference|-9.2|||<|0.001|TWO_SIDED|95.0|-10.9|-7.5|||Mixed Models Analysis|||||-7.5|-10.9|<0.001
73886248|NCT05024032|147306401|SUPERIORITY||Odds Ratio (OR)|13.19|||<|0.001|TWO_SIDED|95.0|5.63|30.89|||Regression, Logistic|||||30.89|5.63|<0.001
73886249|NCT05024032|147306401|SUPERIORITY||Odds Ratio (OR)|28.58|||<|0.001|TWO_SIDED|95.0|11.23|72.71|||Regression, Logistic|||||72.71|11.23|<0.001
73886250|NCT05024032|147306402|SUPERIORITY||Odds Ratio (OR)|25.64|||<|0.001|TWO_SIDED|95.0|6.68|98.49|||Regression, Logistic|||||98.49|6.68|<0.001
74079074|NCT02450539|147711772|SUPERIORITY||Hazard Ratio (HR)|1.184||||0.7039|TWO_SIDED|95.0|0.502|2.792|||Stratified Log Rank||Stratified Cox regression model.|Stratification factors are baseline ECOG performance status (0 vs 1), Number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).||2.792|0.502|0.7039
74079075|NCT02450539|147711773|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|||||||||Headache||||
74079076|NCT02450539|147711773|SUPERIORITY||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|||||||||Diarrhea||||
74079077|NCT02450539|147711773|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|||||||||Mean core symptom severity||||
73886251|NCT05024032|147306402|SUPERIORITY||Odds Ratio (OR)|69.79|||<|0.001|TWO_SIDED|95.0|17.69|275.37|||Regression, Logistic|||||275.37|17.69|<0.001
74079078|NCT02450539|147711773|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|||||||||Mean interference||||
73886252|NCT05024032|147306403|SUPERIORITY||LS Mean Difference|-9.2|||<|0.001|TWO_SIDED|95.0|-11.5|-6.9|||Mixed Models Analysis|||||-6.9|-11.5|<0.001
73886253|NCT05024032|147306403|SUPERIORITY||LS Mean Difference|-13.7|||<|0.001|TWO_SIDED|95.0|-16.0|-11.3|||Mixed Models Analysis|||||-11.3|-16.0|<0.001
73886254|NCT05024032|147306404|SUPERIORITY||LS Mean Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-13.5|-8.3|||Mixed Models Analysis|||||-8.3|-13.5|<0.001
73886255|NCT05024032|147306404|SUPERIORITY||LS Mean Difference|-16.0|||<|0.001|TWO_SIDED|95.0|-18.6|-13.4|||Mixed Models Analysis|||||-13.4|-18.6|<0.001
73886256|NCT05024032|147306405|SUPERIORITY||LS Mean Difference|-3.9|||<|0.001|TWO_SIDED|95.0|-4.8|-3.1|||Mixed Models Analysis|||||-3.1|-4.8|<0.001
73886257|NCT05024032|147306405|SUPERIORITY||LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|95.0|-6.4|-4.8|||Mixed Models Analysis|||||-4.8|-6.4|<0.001
73886258|NCT05024032|147306406|SUPERIORITY||LS Mean Difference|-0.37|||<|0.001|TWO_SIDED|95.0|-0.46|-0.28|||Mixed Models Analysis|||||-0.28|-0.46|<0.001
73886259|NCT05024032|147306406|OTHER||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.48|-0.29|||Mixed Models Analysis|||||-0.29|-0.48|<0.001
73886260|NCT05024032|147306407|SUPERIORITY||LS Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.61|-0.32|||Mixed Models Analysis|||||-0.32|-0.61|<0.001
73886261|NCT05024032|147306407|SUPERIORITY||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.69|-0.4|||Mixed Models Analysis|||||-0.40|-0.69|<0.001
73886262|NCT05024032|147306408|SUPERIORITY||LS Mean Difference|1.2||||0.044|TWO_SIDED|95.0|0.0|2.3|||ANCOVA|||||2.3|0.0|0.044
73886263|NCT05024032|147306408|SUPERIORITY||LS Mean Difference|1.2||||0.05|TWO_SIDED|95.0|0.0|2.3|||ANCOVA|||||2.3|0.0|0.050
73886264|NCT05024032|147306409|SUPERIORITY||LS Mean Difference|7.8|||<|0.001|TWO_SIDED|95.0|3.7|11.8|||ANCOVA|||||11.8|3.7|<0.001
73886265|NCT05024032|147306409|SUPERIORITY||LS Mean Difference|8.5|||<|0.001|TWO_SIDED|95.0|4.4|12.7|||ANCOVA|||||12.7|4.4|<0.001
73886266|NCT05024032|147306410|SUPERIORITY||LS Mean Difference|-4.8|||<|0.001|TWO_SIDED|95.0|-6.9|-2.7|||Mixed Models Analysis|||||-2.7|-6.9|<0.001
73886267|NCT05024032|147306411|SUPERIORITY||LS Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-9.1|-3.1|||Mixed Models Analysis|||||-3.1|-9.1|<0.001
73886268|NCT05024032|147306412|SUPERIORITY||LS Mean Difference|-0.31|||||TWO_SIDED|95.0|-0.51|-0.11||||||||-0.11|-0.51|
73886269|NCT05024032|147306413|SUPERIORITY||LS Mean Difference|0.09|||||TWO_SIDED|95.0|0.03|0.14||||||||0.14|0.03|
74079079|NCT02450539|147711773|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|||||||||Mean lung cancer symptom severity||||
74079080|NCT02450539|147711773|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|||||||||Mean core plus lung cancer symptom severity||||
74079081|NCT02450539|147711773|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|||||||||Mean brain tumor symptom severity||||
74079082|NCT02450539|147711773|SUPERIORITY||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|||||||||Mean core plus lung worst 5 symptoms severity||||
74079083|NCT02450539|147711773|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|||||||||Rash||||
74079084|NCT02450539|147711774|SUPERIORITY||Mean Difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|||||||||EQ VAS Overall Self-rated Health Score||||
74079085|NCT02450539|147711775|SUPERIORITY||Median Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|||||||||EQ-5D-5L Index Value||||
74079086|NCT02699463|147711776|SUPERIORITY||||||<|0.01||||||The calculated p-value was \<0.01|ANCOVA|||||||<0.01
74079087|NCT01108445|147711785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.157|TWO_SIDED||||||Log Rank|||||||0.157
73886270|NCT05024032|147306414|SUPERIORITY||LS Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.25|0.13||||||||0.13|-0.25|
73886271|NCT05024032|147306415|SUPERIORITY||LS Mean Difference|-0.25|||||TWO_SIDED|95.0|-0.34|-0.16||||||||-0.16|-0.34|
73886272|NCT05024032|147306416|SUPERIORITY||LS Mean Difference|-0.58|||||TWO_SIDED|95.0|-0.79|-0.37||||||||-0.37|-0.79|
73886273|NCT05024032|147306417|SUPERIORITY||LS Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.12|-0.01||||||||-0.01|-0.12|
73886274|NCT05024032|147306418|SUPERIORITY||LS Mean Difference|-6.3|||||TWO_SIDED|95.0|-8.6|-4.0||||||||-4.0|-8.6|
73886275|NCT03714672|147306427|SUPERIORITY||Mean Difference (Final Values)|-4.1|||<|0.0001|TWO_SIDED|95.0|-4.8|-3.4|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.||-3.4|-4.8|<0.0001
73886276|NCT03714672|147306427|SUPERIORITY||Mean Difference (Final Values)|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.2|-3.8|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.||-3.8|-5.2|<0.0001
73886277|NCT03714672|147306427|SUPERIORITY||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.5|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.||-2.5|-3.9|<0.0001
73886278|NCT03714672|147306427|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.1|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.||-2.1|-3.5|<0.0001
73886279|NCT02345070|147306437|SUPERIORITY|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least Square (LS) Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.05|=|0.6339|TWO_SIDED|95.0|-2.56|1.56||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg qw versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was done sequentially in order the outcome measures were reported. Analyzed using Mixed Model for Repeated Measurements (MMRM) with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.||1.56|-2.56|= 0.6339
73886280|NCT02345070|147306437|SUPERIORITY|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.04|=|0.5874|TWO_SIDED|95.0|-1.47|2.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg q2w versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was performed sequentially in the order outcome measures were reported (q2w dose group compared to placebo). Analysis was performed using MMRM with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.||2.6|-1.47|= 0.5874
74079088|NCT01108445|147711787|SUPERIORITY_OR_OTHER||Median PFS|5.6|||||TWO_SIDED||||||||The 95% CI for the HC was (4,6). If the median PFS for RAD001 is within the 95% CI for the HC, it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for RAD001 arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.||||
73886281|NCT02584686|147306537|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 1 sided|||Comparing the mean PSV before \& after treatment in the study group using the t-test.||||0.0049
73886282|NCT02584686|147306537|SUPERIORITY_OR_OTHER|||||||0.68|||||||t-test, 1 sided|||Comparing the mean PSV before \& after treatment in the control group using the t-test.||||0.68
73886283|NCT02584686|147306539|SUPERIORITY_OR_OTHER|||||||0.01086956|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before \& after treatment in the study group.||||0.01086956
73886284|NCT02584686|147306539|SUPERIORITY_OR_OTHER|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before \& after treatment in the control group.||||0.6618176
73886285|NCT02584686|147306541|SUPERIORITY_OR_OTHER|||||||0.00751288|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the study group before \& after treatment.||||0.00751288
73886286|NCT02584686|147306541|SUPERIORITY_OR_OTHER|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the control group before \& after treatment.||||0.6618176
73886287|NCT02584686|147306542|SUPERIORITY_OR_OTHER|||||||0.027191||||||"Due to the small sample size Fisher exact test was chosen. 7 out of 12 in the treatment group answered yes, while 1 out of 12 in the control group answered yes."|Fisher Exact|||||||0.027191
73886288|NCT02584686|147306544|SUPERIORITY_OR_OTHER|||||||0.109091|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in the number of in patients who answered Yes in Secondary Outcome 8 (SEP-Q2 Question Before Treatment) to patients who answered Yes in Secondary Outcome 9 (SEP-Q2 Question after Treatment), for both (BTXA) and Saline groups."||||0.109091
73886289|NCT02584686|147306546|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in patients who answered Yes in Secondary Outcome 10 (SEP-Q3 Question Before Treatment) to patients who answered Yes in Secondary Outcome 11 (SEP-Q3 Question after Treatment)."||||1
73886290|NCT03137381|147306550|SUPERIORITY|||||||0.177|||||||Chi-squared|||||||0.177
73886291|NCT03137381|147306550|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73886292|NCT03137381|147306550|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73888409|NCT02900378|147309622|OTHER|||||||0.2275|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.2275
74079089|NCT01108445|147711787|SUPERIORITY_OR_OTHER||Median PFS|8.3|||||TWO_SIDED||||||||95% CI for HC was(4,6). If the median PFS for Sunitinib is within the 95% CI for the HC,it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for Sunitinib arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.||||
74079090|NCT01108445|147711789|SUPERIORITY_OR_OTHER|||||||0.589|TWO_SIDED||||||Chi-squared|||||||0.589
74079091|NCT01108445|147711790|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Chi-squared|||||||0.066
74079092|NCT04188392|147711802|OTHER|Rate of subjects enrolled per month of recruitment; based on 6 subjects enrolled over 5.8 months of recruitment.|Rate (per month)|1.03|||||TWO_SIDED|95.0|0.38|2.25|||||Based on 6 subjects enrolled over 5.8 months of recruitment|Recruitment goal of 6 subjects total.||2.25|0.38|
73888410|NCT02900378|147309622|OTHER|||||||0.3486|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.3486
74079093|NCT04188392|147711803|OTHER|Total participants = 6; completed protocol: yes = 6, no = 0|Point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate = 100% (95% C.I. 54%,100%)|Binary outcome (completed protocol yes vs. no); goal of 75% of subjects completing protocol|Point estimate of completion rate and 95% confidence interval|1|0.54|
74079094|NCT04188392|147711804|OTHER|paired t-test|Mean of the differences|21.7||||0.2873|TWO_SIDED|95.0|-27.4|70.8||A priori significance threshold of p\<0.05|t-test, 2 sided|t=1.2263, df=4||alternative hypothesis: true difference in means is not equal to 0||70.8|-27.4|0.2873
74079095|NCT04188392|147711805|OTHER|Total participants = 6; discontinued due to adverse effects: yes = 0, no =6|Point estimate, 95% confidence interval|0.0|||||TWO_SIDED|95.0|0.0|0.46|||||Discontinuation rates due to adverse effects: Point estimate 0% (95% C.I. 0%, 45.9%)|Binary outcome: Discontinued due to adverse effects yes vs. no||0.46|0|
74079096|NCT04188392|147711806|OTHER|Total participants = 6; completed sleep study 1: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for sleep study 1 = 100% (95% C.I. 54%, 100%)|Binary outcome: Completed sleep study 1 yes vs. no||1|0.54|
73886293|NCT01684917|147306552|SUPERIORITY||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
73886294|NCT01684917|147306552|SUPERIORITY||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
73886295|NCT01684917|147306553|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
73886296|NCT01684917|147306554|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
73886297|NCT01684917|147306555|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
73886298|NCT01684917|147306555|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
73886299|NCT01684917|147306555|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
73886300|NCT01684917|147306557|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
73886301|NCT03367793|147306563|OTHER||f statistic|1.1||||0.341|TWO_SIDED|||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.341
73886302|NCT03367793|147306563|OTHER||least square means|0.31|||||TWO_SIDED|95.0|0.26|0.36|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for PFST.|||0.36|0.26|
73886303|NCT03367793|147306563|OTHER||least square means|0.33|||||TWO_SIDED|95.0|0.27|0.38|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for VSX.|||0.38|0.27|
73886304|NCT03367793|147306563|OTHER||least square means|0.34|||||TWO_SIDED|95.0|0.28|0.39|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.|||0.39|0.28|
73886305|NCT03367793|147306564|OTHER||f statistic|0.93||||0.41|TWO_SIDED|||||The threshold for statistical significance was 0.05.|f test|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.410
74079097|NCT04188392|147711806|OTHER|Total participants = 6; completed sleep study 2: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for sleep study 2 = 100% (95% C.I. 54%, 100%)|Binary outcome: completed sleep study 2 yes vs. no||1|0.54|
73886306|NCT03367793|147306564|OTHER||least square means|0.35|||||TWO_SIDED|95.0|0.28|0.41|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for PFST.|||0.41|0.28|
73886307|NCT03367793|147306564|OTHER||least square means|0.33|||||TWO_SIDED|95.0|0.26|0.39|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for VSX.|||0.39|0.26|
73886308|NCT03367793|147306564|OTHER||least square means|0.34|||||TWO_SIDED|95.0|0.28|0.41|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.|||0.41|0.28|
73886309|NCT03367793|147306565|OTHER||f statistic|1.09||||0.351|TWO_SIDED|||||The threshold for statistical significance was alpha=0.05.|f test|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.351
73886310|NCT03367793|147306565|OTHER||least square means|11.0|||||TWO_SIDED|95.0|9.3|12.7|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for PFST.|||12.7|9.3|
73886311|NCT03367793|147306565|OTHER||least square means|10.9|||||TWO_SIDED|95.0|9.2|12.6|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for VSX.|||12.6|9.2|
73886312|NCT03367793|147306565|OTHER||least square means|11.2|||||TWO_SIDED|95.0|9.5|12.9|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for Clinical Refraction.|||12.9|9.5|
73886313|NCT03367793|147306566|OTHER||f statistic|0.58||||0.562|TWO_SIDED||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||0.562
73886314|NCT03367793|147306566|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for PFST.|||||
73888411|NCT02900378|147309622|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.6800
74079098|NCT04188392|147711806|OTHER|Total participants = 6; completed sleep study 3: yes = 5, no=1|point estimate|0.83|||||TWO_SIDED|95.0|0.36|0.996|||||Point estimate of completion rate for sleep study 3 = 83.3% (95% C.I. 36%, 99.6%)|Binary outcome: completed sleep study 3 yes vs. no||0.996|0.36|
74079099|NCT04188392|147711806|OTHER|Total participants = 6; at least 4 days of actigraphy data: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for at least 4 days of actigraphy pre-treatment = 100% (95% C.I. 54%, 100%).|Binary outcome: at least 4 days of actigraphy data pre-treatment yes vs. no||1|0.54|
74079100|NCT04188392|147711806|OTHER|Total participants = 6; at least 4 days of actigraphy post-treatment: yes = 6, no =0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of actigraphy post-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of actigraphy post-treatment yes vs. no||1|0.54|
74079101|NCT04188392|147711806|OTHER|Total participants = 6; at least 4 days of sleep diary pre-treatment: yes = 6, no = 0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of sleep diary pre-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of sleep diary pre-treatment yes vs. no||1|0.54|
74079102|NCT04188392|147711806|OTHER|Total participants = 6; at least 4 days of sleep diary post-treatment: yes = 6, no = 0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of sleep diary post-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of sleep diary post-treatment yes vs. no||1|0.54|
74079103|NCT05283148|147711816|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.321||||||A p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the lumbar spine. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.321
74079104|NCT05283148|147711817|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.714||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA lumbar spine scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.714
74079105|NCT05283148|147711818|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.09||||||p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the total hip. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.09
74079106|NCT05283148|147711819|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.604||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test (two sided)|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA total hip scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.604
74079107|NCT05283148|147711820|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.013||||||A p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the femoral neck. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.013
74079108|NCT05283148|147711821|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.166||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA femoral neck scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.166
74079109|NCT05283148|147711822|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.23||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test (two sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (interquartile range) for each group, based on the ASCQ-Me Pain Impact instrument (lower scores indicate worse pain impact). Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.23
74079110|NCT00095784|147711831|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CD34+ cell levels. Analysis performed on log scale.||||<0.0001
74079111|NCT00095784|147711837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CXCR4 levels. Analysis performed on log scale.||||0.29
74079112|NCT00095784|147711843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in hemoglobin F levels.||||0.99
74079113|NCT00835614|147711854|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.9||||||90.0|87.5|94.4|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||94.4|87.5|
73886315|NCT03367793|147306566|OTHER||proportion|0.933|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for VSX.|||||
74079114|NCT00835614|147711855|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.1||||||90.0|90.3|93.9|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||93.9|90.3|
74079115|NCT00835614|147711856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.2||||||90.0|90.4|94.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||94|90.4|
74079116|NCT00829712|147711858|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.95||||||90.0|94.02|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.39|94.02|
74079117|NCT00829712|147711859|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|95.08|103.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.19|95.08|
74079118|NCT00829712|147711860|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.94||||||90.0|96.08|103.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.95|96.08|
74079119|NCT00606281|147711861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-9.4|-2.7|||ANCOVA|||||-2.7|-9.4|<0.001
74079120|NCT00606281|147711862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001||95.0|-1.1|-0.3|||ANCOVA|||||-0.3|-1.1|<0.001
74079121|NCT01640197|147711882|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
74079122|NCT01640197|147711883|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
74079123|NCT01640197|147711884|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
74079124|NCT01640197|147711885|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
74079125|NCT01640197|147711886|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
74079126|NCT01640197|147711887|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
74079127|NCT01640197|147711888|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
74079128|NCT00835692|147711894|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Mean x 100|98.4||||||90.0|91.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|91.5|
74079129|NCT00835692|147711895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.6|97.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.6|89.6|
74079130|NCT00835692|147711896|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.5|97.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.7|89.5|
74079131|NCT01149733|147711897|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|97.9|||||TWO_SIDED|90.0|91.0|105.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||105.32|91.00|
74079132|NCT01149733|147711898|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|91.81|||||TWO_SIDED|90.0|87.72|96.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||96.10|87.72|
73888412|NCT02900378|147309622|OTHER|||||||0.7184|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.7184
74079133|NCT01149733|147711899|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|90.64|||||TWO_SIDED|90.0|86.59|94.89|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||94.89|86.59|
74079134|NCT00115063|147711934|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74079135|NCT00115063|147711935|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
74079136|NCT00115063|147711936|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value for systolic blood pressure mean.|t-test, 2 sided|||||||0.09
73886316|NCT03367793|147306566|OTHER||proportion|0.897|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for Clinical Refraction.|||||
74079137|NCT00115063|147711936|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value for dystolic blood pressure mean.|t-test, 2 sided|||||||0.60
73886317|NCT03367793|147306567|OTHER||||||>|0.99|||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||>0.99
73886318|NCT03367793|147306567|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for PFST.|||||
73886319|NCT03367793|147306567|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for VSX.|||||
73886320|NCT03367793|147306567|OTHER||proportion|0.966|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for Clinical Refraction.|||||
73886321|NCT03367793|147306568|OTHER||||||>|0.99|||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||>0.99
73886322|NCT03367793|147306568|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for PFST.|||||
73886323|NCT03367793|147306568|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for VSX.|||||
73886324|NCT03367793|147306568|OTHER||proportion|0.966|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for Clinical Refraction.|||||
73886325|NCT00423579|147306569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.5||||0||95.0|-18.9|-10.1|||Student's t test for independent data||Difference in percentage change in mean LDL-C values (change from baseline to week 6) between the two treatment groups. (Ezetimibe \[EZ\]/Simvastatin \[S\] \[10/20mg\] + S \[placebo\] group minus the EZ/S \[10mg/placebo\] + S \[40mg\] group)|||-10.1|-18.9|0.0000
73886326|NCT02392637|147306570|SUPERIORITY|||||||0.62|||||||Log Rank|||||||0.62
73886327|NCT02392637|147306571|SUPERIORITY|||||||0.39|||||||Log Rank|||||||0.39
73886328|NCT00106704|147306573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-90.0|-0.57|||ANCOVA|Model terms: treatment, stratum (on metformin or not), baseline A1C||||-0.57|-90.0|<0.001
73886329|NCT00106704|147306574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.1|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-28.4|-11.8|||ANCOVA|Model terms: treatment, stratum (on metformin or not at Visit 3), baseline A1C||||-11.8|-28.4|<0.001
73886330|NCT02224560|147306575|SUPERIORITY||Median Difference (Final Values)|-21.57||||0.0047|TWO_SIDED|95.0|-34.79|-6.67|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-6.67|-34.79|0.0047
74079138|NCT00115063|147711937|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value for LDL cholesterol|t-test, 2 sided|||||||0.73
73886331|NCT02224560|147306575|SUPERIORITY||Median Difference (Final Values)|-19.19||||0.0016|TWO_SIDED|95.0|-31.24|-7.69|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-7.69|-31.24|0.0016
73886332|NCT02224560|147306576|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0006|TWO_SIDED|95.0|1.75|8.47||Calculated using a Cochran-Mantel-Haenszel (CMH) test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel|||||8.47|1.75|0.0006
74079139|NCT00115063|147711937|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for HDL cholesterol|t-test, 2 sided|||||||0.01
73886333|NCT02224560|147306576|SUPERIORITY||Odds Ratio (OR)|3.27||||0.003|TWO_SIDED|95.0|1.47|7.26||Calculated using a CMH test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel|||||7.26|1.47|0.0030
73886334|NCT02224560|147306577|SUPERIORITY||Median Difference (Final Values)|-18.76||||0.0091|TWO_SIDED|95.0|-31.8|-4.43|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-4.43|-31.80|0.0091
73886335|NCT02224560|147306577|SUPERIORITY||Median Difference (Final Values)|-19.47||||0.0015|TWO_SIDED|95.0|-30.37|-7.47|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-7.47|-30.37|0.0015
73886336|NCT02224560|147306578|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0439|TWO_SIDED|95.0|1.02|3.3|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale|||3.30|1.02|0.0439
73886337|NCT02224560|147306578|SUPERIORITY||Odds Ratio (OR)|2.57||||0.002|TWO_SIDED|95.0|1.41|4.66|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale|||4.66|1.41|0.0020
73886338|NCT03773978|147306580|SUPERIORITY||Hazard Ratio (HR)|0.241|||<|0.001|TWO_SIDED|95.0|0.128|0.453|||Log Rank|||||0.453|0.128|<0.001
73886339|NCT03773978|147306581|SUPERIORITY||Odds Ratio (OR)|2.72||||0.052|TWO_SIDED|95.0|0.99|7.46|||Regression, Logistic|||at week 16||7.46|0.99|0.052
73886340|NCT03773978|147306581|SUPERIORITY||Odds Ratio (OR)|3.64||||0.002|TWO_SIDED|95.0|1.6|8.28|||Regression, Logistic|||at week 20||8.28|1.60|0.002
73886341|NCT03773978|147306581|SUPERIORITY||Odds Ratio (OR)|4.34|||<|0.001|TWO_SIDED|95.0|2.0|9.41|||Regression, Logistic|||at week 24||9.41|2.00|<0.001
73886342|NCT03773978|147306581|SUPERIORITY||Odds Ratio (OR)|3.37||||0.001|TWO_SIDED|95.0|1.62|7.01|||Regression, Logistic|||at week 28||7.01|1.62|0.001
73886343|NCT03773978|147306581|SUPERIORITY||Odds Ratio (OR)|3.0||||0.002|TWO_SIDED|95.0|1.48|6.07|||Regression, Logistic|||at week 32||6.07|1.48|0.002
73886344|NCT03773978|147306581|SUPERIORITY||Odds Ratio (OR)|3.25|||<|0.001|TWO_SIDED|95.0|1.62|6.52|||Regression, Logistic|||at week 36||6.52|1.62|<0.001
73886345|NCT03773978|147306581|SUPERIORITY||Odds Ratio (OR)|3.7|||<|0.001|TWO_SIDED|95.0|1.85|7.41|||Regression, Logistic|||at week 40||7.41|1.85|<0.001
73886346|NCT03773978|147306581|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.65|6.5|||Regression, Logistic|||at week 44||6.50|1.65|<0.001
74079140|NCT00115063|147711937|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value for triglycerides|t-test, 2 sided|||||||0.42
74079141|NCT00115063|147711937|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for uric acid|t-test, 2 sided|||||||0.05
73886347|NCT03773978|147306582|SUPERIORITY||Odds Ratio (OR)|1.25||||0.568|TWO_SIDED|95.0|0.59|2.65|||Regression, Logistic|||at week 16||2.65|0.59|0.568
73886348|NCT03773978|147306582|SUPERIORITY||Odds Ratio (OR)|2.92||||0.004|TWO_SIDED|95.0|1.4|6.09|||Regression, Logistic|||at week 20||6.09|1.40|0.004
73886349|NCT03773978|147306582|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.001|TWO_SIDED|95.0|2.1|9.15|||Regression, Logistic|||at week 24||9.15|2.10|<0.001
74079142|NCT00115063|147711938|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
73886350|NCT03773978|147306582|SUPERIORITY||Odds Ratio (OR)|3.09||||0.002|TWO_SIDED|95.0|1.51|6.32|||Regression, Logistic|||at week 28||6.32|1.51|0.002
73886351|NCT03773978|147306582|SUPERIORITY||Odds Ratio (OR)|2.99||||0.003|TWO_SIDED|95.0|1.47|6.11|||Regression, Logistic|||at week 32||6.11|1.47|0.003
74079143|NCT00115063|147711939|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
73886352|NCT03773978|147306582|SUPERIORITY||Odds Ratio (OR)|2.84||||0.003|TWO_SIDED|95.0|1.44|5.6|||Regression, Logistic|||at week 36||5.60|1.44|0.003
74079144|NCT01075282|147711940|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of LY2189265 1.5 mg vs insulin glargine on HbA1c change from baseline at the 52-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 20%.||-0.29|-0.60|<0.001
74079145|NCT01075282|147711940|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.13|||<|0.001|TWO_SIDED|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||0.02|-0.29|<0.001
74079146|NCT01075282|147711940|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.29|-0.60|<0.001
74079147|NCT01075282|147711940|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.05|TWO_SIDED|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||0.02|-0.29|0.05
74079148|NCT01075282|147711941|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.37|-0.65|<0.001
74079149|NCT01075282|147711941|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.10|-0.38|<0.001
74079150|NCT01075282|147711941|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.37|-0.65|<0.001
74079151|NCT01075282|147711941|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.10|-0.38|<0.001
74079152|NCT01075282|147711941|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.13|-0.50|<0.001
74079153|NCT01075282|147711941|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.03|||<|0.001|TWO_SIDED|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||0.15|-0.21|<0.001
74079154|NCT01075282|147711941|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.13|-0.50|<0.001
74079155|NCT01075282|147711941|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.378|TWO_SIDED|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||0.15|-0.21|0.378
74079156|NCT01075282|147711942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.61|||<|0.001|TWO_SIDED|95.0|2.98|7.11||Treatment comparison at 26 weeks.|Regression, Logistic|||||7.11|2.98|<0.001
74079157|NCT01075282|147711942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.41|3.24||Treatment comparison at 26 weeks.|Regression, Logistic|||||3.24|1.41|<0.001
74079158|NCT01075282|147711942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.001|TWO_SIDED|95.0|2.45|5.75||Treatment comparison at 52 weeks.|Regression, Logistic|||||5.75|2.45|<0.001
73886353|NCT03773978|147306582|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.74|6.97|||Regression, Logistic|||at week 40||6.97|1.74|<0.001
73886354|NCT03773978|147306582|SUPERIORITY||Odds Ratio (OR)|2.87||||0.002|TWO_SIDED|95.0|1.46|5.66|||Regression, Logistic|||at week 44||5.66|1.46|0.002
73886355|NCT03773978|147306583|SUPERIORITY||Odds Ratio (OR)|0.99||||0.972|TWO_SIDED|95.0|0.52|1.87|||Regression, Logistic|||at week 16||1.87|0.52|0.972
73886356|NCT03773978|147306583|SUPERIORITY||Odds Ratio (OR)|2.47||||0.008|TWO_SIDED|95.0|1.27|4.81|||Regression, Logistic|||at week 20||4.81|1.27|0.008
73886357|NCT03773978|147306583|SUPERIORITY||Odds Ratio (OR)|2.57||||0.005|TWO_SIDED|95.0|1.33|4.97|||Regression, Logistic|||at week 24||4.97|1.33|0.005
73886358|NCT03773978|147306583|SUPERIORITY||Odds Ratio (OR)|3.06|||<|0.001|TWO_SIDED|95.0|1.57|5.94|||Regression, Logistic|||at week 28||5.94|1.57|<0.001
74079159|NCT01075282|147711942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.098|TWO_SIDED|95.0|0.94|2.15||Treatment comparison at 52 weeks.|Regression, Logistic|||||2.15|0.94|0.098
74079160|NCT01075282|147711942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.85|4.14||Treatment comparison at 78 weeks.|Regression, Logistic|||||4.14|1.85|<0.001
74079161|NCT01075282|147711942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.334|TWO_SIDED|95.0|0.82|1.82||Treatment comparison at 78 weeks.|Regression, Logistic|||||1.82|0.82|0.334
74079162|NCT01075282|147711943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7|||<|0.001|TWO_SIDED|95.0|2.9|7.63||Treatment comparison at 26 weeks.|Regression, Logistic|||||7.63|2.90|<0.001
74079163|NCT01075282|147711943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54|||<|0.001|TWO_SIDED|95.0|1.57|4.11||Treatment comparison at 26 weeks.|Regression, Logistic|||||4.11|1.57|<0.001
74079164|NCT01075282|147711943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.001|TWO_SIDED|95.0|1.81|4.85||Treatment comparison at 52 weeks.|Regression, Logistic|||||4.85|1.81|<0.001
74079165|NCT01075282|147711943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07||||0.004|TWO_SIDED|95.0|1.26|3.39||Treatment comparison at 52 weeks.|Regression, Logistic|||||3.39|1.26|0.004
74079166|NCT01075282|147711943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.001|TWO_SIDED|95.0|1.44|3.57||Treatment comparison at 78 weeks.|Regression, Logistic|Treatment comparison at 78 weeks.||||3.57|1.44|<0.001
74079167|NCT01075282|147711943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.073|TWO_SIDED|95.0|0.96|2.42||Treatment comparison at 78 weeks.|Regression, Logistic|||||2.42|0.96|0.073
74079168|NCT01075282|147711944|SUPERIORITY_OR_OTHER|||||||0.109||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.109
73886359|NCT03773978|147306583|SUPERIORITY||Odds Ratio (OR)|2.42||||0.009|TWO_SIDED|95.0|1.25|4.71|||Regression, Logistic|||at week 32||4.71|1.25|0.009
74079169|NCT01075282|147711944|SUPERIORITY_OR_OTHER|||||||0.335||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.335
74079170|NCT01075282|147711944|SUPERIORITY_OR_OTHER|||||||0.091||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.091
74079171|NCT01075282|147711944|SUPERIORITY_OR_OTHER|||||||0.4||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.400
74079172|NCT01075282|147711944|SUPERIORITY_OR_OTHER|||||||0.641||||||Treatment comparison at 78 weeks.|Mixed Models Analysis|||||||0.641
74079173|NCT01075282|147711944|SUPERIORITY_OR_OTHER|||||||0.055||||||Treatment comparison at 78 weeks.|Mixed Models Analysis|||||||0.055
74079174|NCT01075282|147711947|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|||<|0.001|TWO_SIDED|95.0|2.33|3.33||Treatment comparison at 26 weeks.|ANCOVA|||||3.33|2.33|<0.001
74079175|NCT01075282|147711947|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48|||<|0.001|TWO_SIDED|95.0|1.99|2.99||Treatment comparison at 26 weeks.|ANCOVA|||||2.99|1.99|<0.001
74079176|NCT01075282|147711947|SUPERIORITY_OR_OTHER||LS Mean Difference|3.31|||<|0.001|TWO_SIDED|95.0|2.71|3.9||Treatment comparison at 52 weeks.|ANCOVA|||||3.90|2.71|<0.001
74079177|NCT01075282|147711947|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|2.17|3.36||Treatment comparison at 52 weeks.|ANCOVA|||||3.36|2.17|<0.001
74079178|NCT01075282|147711947|SUPERIORITY_OR_OTHER||LS Mean Difference|3.24|||<|0.001|TWO_SIDED|95.0|2.59|3.89||Treatment comparison at 78 weeks.|ANCOVA|||||3.89|2.59|<0.001
74079179|NCT01075282|147711947|SUPERIORITY_OR_OTHER||LS Mean Difference|2.82|||<|0.001|TWO_SIDED|95.0|2.17|3.46||Treatment comparison at 78 weeks.|ANCOVA|||||3.46|2.17|<0.001
74079180|NCT01447511|147711988|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.||||<0.0001
74079181|NCT01447511|147711988|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.||||=0.0001
74079182|NCT01447511|147711988|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.||||<0.0001
74079183|NCT01447511|147711988|SUPERIORITY_OR_OTHER||||||=|0.3058|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.||||=0.3058
74079184|NCT01447511|147711988|SUPERIORITY_OR_OTHER||||||=|0.3278|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.||||=0.3278
73886360|NCT03773978|147306583|SUPERIORITY||Odds Ratio (OR)|2.8||||0.003|TWO_SIDED|95.0|1.43|5.47|||Regression, Logistic|||at week 36||5.47|1.43|0.003
74079185|NCT01447511|147711988|SUPERIORITY_OR_OTHER||||||=|0.6155|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.||||=0.6155
74079186|NCT02679729|147711995|SUPERIORITY_OR_OTHER||Slope|0.625|||||TWO_SIDED|95.0|0.396|0.853||||||Statistical Analysis for Part A||0.853|0.396|
74079187|NCT02679729|147711996|SUPERIORITY_OR_OTHER||Slope|1.2|||||TWO_SIDED|95.0|0.905|1.49||||||Statistical Analysis for Part A||1.49|0.905|
74079188|NCT02679729|147711997|SUPERIORITY_OR_OTHER||Slope|1.55|||||TWO_SIDED|95.0|1.34|1.76||||||Statistical Analysis for Part A||1.76|1.34|
74079189|NCT04667338|147712011|SUPERIORITY||||||=|0.5061|||||||Chi-squared|||Pharmacological||||=0.5061
74079190|NCT04667338|147712011|SUPERIORITY||||||=|0.2053|||||||Chi-squared|||Non-pharmacological||||=0.2053
74079191|NCT04667338|147712012|SUPERIORITY||||||=|0.4016|||||||Chi-squared|||||||=0.4016
74079192|NCT04667338|147712015|SUPERIORITY||||||=|0.5274|||||||Chi-squared|||Educational level ongoing or completed level of education||||=0.5274
74079193|NCT04667338|147712015|SUPERIORITY||||||=|0.7051|||||||Chi-squared|||Occupational status and occupation||||=0.7051
74079194|NCT04667338|147712015|SUPERIORITY||||||=|0.3543|||||||Chi-squared|||Civil status||||=0.3543
74079195|NCT04667338|147712015|SUPERIORITY||||||=|0.0368|||||||Chi-squared|||Living conditions||||=0.0368
74079196|NCT04667338|147712015|SUPERIORITY||||||=|0.3512|||||||Chi-squared|||Smoking status||||=0.3512
74079197|NCT04667338|147712015|SUPERIORITY||||||=|0.104|||||||Chi-squared|||Alcohol intake||||=0.1040
74079198|NCT04667338|147712015|SUPERIORITY||||||=|0.0202|||||||Chi-squared|||Exercise status||||=0.0202
74079199|NCT04667338|147712015|SUPERIORITY||||||=|0.3503|||||||Chi-squared|||Family history of narcolepsy||||=0.3503
74079200|NCT04667338|147712020|SUPERIORITY||||||=|0.0715|||||||Chi-squared|||General practitioner||||=0.0715
74079201|NCT04667338|147712020|SUPERIORITY||||||=|0.0929|||||||Chi-squared|||Neurologist||||=0.0929
73886361|NCT03773978|147306583|SUPERIORITY||Odds Ratio (OR)|2.93||||0.002|TWO_SIDED|95.0|1.47|5.83|||Regression, Logistic|||at week 40||5.83|1.47|0.002
73886362|NCT03773978|147306583|SUPERIORITY||Odds Ratio (OR)|1.93||||0.052|TWO_SIDED|95.0|0.99|3.74|||Regression, Logistic|||at week 44||3.74|0.99|0.052
74079202|NCT04667338|147712020|SUPERIORITY||||||=|0.3092|||||||Chi-squared|||Neuropediatrician||||=0.3092
74079203|NCT04667338|147712020|SUPERIORITY||||||=|0.4528|||||||Chi-squared|||Neurophysiologist||||=0.4528
74079204|NCT04667338|147712020|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Pneumologist||||<0.0001
74079205|NCT04667338|147712020|SUPERIORITY||||||=|0.1785|||||||Chi-squared|||Somnologist||||=0.1785
74079206|NCT04667338|147712020|SUPERIORITY||||||=|0.1474|||||||Chi-squared|||Somnologist-unit||||=0.1474
74079207|NCT04667338|147712021|SUPERIORITY||||||=|0.2042|||||||Chi-squared|||Clinical history||||=0.2042
74079208|NCT04667338|147712021|SUPERIORITY||||||=|0.5818|||||||Chi-squared|||Clinical assessment: ESS||||=0.5818
74079209|NCT04667338|147712021|SUPERIORITY||||||=|0.0368|||||||Chi-squared|||Neurological assessment||||=0.0368
74079210|NCT04667338|147712021|SUPERIORITY||||||=|0.1128|||||||Chi-squared|||MSLT||||=0.1128
74079211|NCT04667338|147712021|SUPERIORITY||||||=|0.3396|||||||Chi-squared|||AHI||||=0.3396
74079212|NCT04667338|147712021|SUPERIORITY||||||=|0.6794|||||||Chi-squared|||Other procedures||||=0.6794
74079213|NCT04667338|147712021|SUPERIORITY||||||=|0.0138|||||||Chi-squared|||HLA typing||||=0.0138
74079214|NCT04667338|147712021|SUPERIORITY||||||=|0.0597|||||||Chi-squared|||Hypocretin-1 CSF or Orexin||||=0.0597
74079215|NCT04667338|147712022|SUPERIORITY||||||=|0.1171|||||||t-test, 2 sided|||||||=0.1171
74079216|NCT04667338|147712023|SUPERIORITY||||||=|0.3834|||||||t-test, 2 sided|||||||=0.3834
74079217|NCT04667338|147712028|SUPERIORITY||||||=|0.0531|||||||t-test, 2 sided|||||||=0.0531
74079218|NCT04667338|147712029|SUPERIORITY||||||=|0.0005|||||||Chi-squared|||Take short naps||||=0.0005
74079219|NCT04667338|147712029|SUPERIORITY||||||=|0.8221|||||||Chi-squared|||Maintain a regular sleep schedule||||=0.8221
74079220|NCT04667338|147712029|SUPERIORITY||||||=|0.2291|||||||Chi-squared|||Avoid caffeine or alcohol before bedtime||||=0.2291
74079221|NCT04667338|147712029|SUPERIORITY||||||=|0.9177|||||||Chi-squared|||Avoid smoking, especially at night||||=0.9177
74079222|NCT04667338|147712029|SUPERIORITY||||||=|0.4188|||||||Chi-squared|||Exercise daily||||=0.4188
74079223|NCT04667338|147712029|SUPERIORITY||||||=|0.5818|||||||Chi-squared|||Avoid large, heavy meals right before bedtime||||=0.5818
74079224|NCT04667338|147712029|SUPERIORITY||||||=|0.5432|||||||Chi-squared|||Other||||=0.5432
74079225|NCT04667338|147712030|SUPERIORITY||||||=|0.5432|||||||Chi-squared|||Treatment||||=0.5432
73886363|NCT03773978|147306584|SUPERIORITY||Odds Ratio (OR)|1.35||||0.409|TWO_SIDED|95.0|0.66|2.75|||Regression, Logistic|||at week 16||2.75|0.66|0.409
73886364|NCT03773978|147306584|SUPERIORITY||Odds Ratio (OR)|2.13||||0.03|TWO_SIDED|95.0|1.07|4.23|||Regression, Logistic|||at week 20||4.23|1.07|0.030
73886365|NCT03773978|147306584|SUPERIORITY||Odds Ratio (OR)|2.36||||0.022|TWO_SIDED|95.0|1.13|4.92|||Regression, Logistic|||at week 24||4.92|1.13|0.022
74079226|NCT04667338|147712030|SUPERIORITY||||||=|0.0397|||||||Chi-squared|||Routine monitoring visits||||=0.0397
74079227|NCT04667338|147712030|SUPERIORITY||||||=|0.0306|||||||Chi-squared|||Tests||||=0.0306
74079228|NCT04667338|147712030|SUPERIORITY||||||=|0.7451|||||||Chi-squared|||Emergency visits||||=0.7451
73886366|NCT03773978|147306584|SUPERIORITY||Odds Ratio (OR)|2.05||||0.04|TWO_SIDED|95.0|1.03|4.08|||Regression, Logistic|||at week 28||4.08|1.03|0.040
73886367|NCT03773978|147306584|SUPERIORITY||Odds Ratio (OR)|2.13||||0.032|TWO_SIDED|95.0|1.07|4.24|||Regression, Logistic|||at week 32||4.24|1.07|0.032
73886368|NCT03773978|147306584|SUPERIORITY||Odds Ratio (OR)|1.71||||0.132|TWO_SIDED|95.0|0.85|3.42|||Regression, Logistic|||at week 36||3.42|0.85|0.132
73886369|NCT03773978|147306584|SUPERIORITY||Odds Ratio (OR)|2.02||||0.05|TWO_SIDED|95.0|1.0|4.1|||Regression, Logistic|||at week 40||4.10|1.00|0.050
73886370|NCT03773978|147306584|SUPERIORITY||Odds Ratio (OR)|2.32||||0.019|TWO_SIDED|95.0|1.15|4.71|||Regression, Logistic|||at week 44||4.71|1.15|0.019
73886371|NCT03773978|147306585|SUPERIORITY||Odds Ratio (OR)|0.8||||0.62|TWO_SIDED|95.0|0.33|1.92|||Regression, Logistic|||at week 16||1.92|0.33|0.620
73886372|NCT03773978|147306585|SUPERIORITY||Odds Ratio (OR)|1.3||||0.492|TWO_SIDED|95.0|0.61|2.78|||Regression, Logistic|||at week 20||2.78|0.61|0.492
74079229|NCT04667338|147712030|SUPERIORITY||||||=|0.0845|||||||Chi-squared|||Hospitalizations||||=0.0845
74079230|NCT04667338|147712030|SUPERIORITY||||||=|0.3813|||||||Chi-squared|||Complications||||=0.3813
74079231|NCT04667338|147712032|SUPERIORITY||||||=|0.0034|||||||t-test, 2 sided|||Absenteeism||||=0.0034
74079232|NCT04667338|147712032|SUPERIORITY||||||=|0.2178|||||||t-test, 2 sided|||Presenteeism||||=0.2178
74079233|NCT04667338|147712032|SUPERIORITY||||||=|0.1758|||||||t-test, 2 sided|||Work productivity loss||||=0.1758
74079234|NCT04667338|147712032|SUPERIORITY||||||=|0.1789|||||||t-test, 2 sided|||Activity Impairment / disability||||=0.1789
74079235|NCT04667338|147712033|SUPERIORITY||||||=|0.5806|||||||Chi-squared|||||||=0.5806
74079236|NCT04667338|147712035|SUPERIORITY||||||=|0.1602|||||||Chi-squared|||Mobility||||=0.1602
74079237|NCT04667338|147712035|SUPERIORITY||||||=|0.5249|||||||Chi-squared|||Self-Care||||=0.5249
74079238|NCT04667338|147712035|SUPERIORITY||||||=|0.1095|||||||Chi-squared|||Usual activities||||=0.1095
74079239|NCT04667338|147712035|SUPERIORITY||||||=|0.3528|||||||Chi-squared|||Pain / Discomfort||||=0.3528
74079240|NCT04667338|147712035|SUPERIORITY||||||=|0.7434|||||||Chi-squared|||Anxiety / Depression||||=0.7434
74079241|NCT04667338|147712036|SUPERIORITY||||||=|0.0396|||||||t-test, 2 sided|||||||=0.0396
74079242|NCT04667338|147712037|SUPERIORITY||||||=|0.0394|||||||t-test, 2 sided|||Effectiveness||||=0.0394
74079243|NCT04667338|147712037|SUPERIORITY||||||=|0.3093|||||||t-test, 2 sided|||Convenience||||=0.3093
74079244|NCT04667338|147712037|SUPERIORITY||||||=|0.2296|||||||t-test, 2 sided|||Global satisfaction||||=0.2296
74079245|NCT04667338|147712038|SUPERIORITY||||||=|0.1817|||||||Chi-squared|||Depression||||=0.1817
74079246|NCT04667338|147712038|SUPERIORITY||||||=|0.0885|||||||Chi-squared|||Bipolar disorder||||=0.0885
74079247|NCT04667338|147712038|SUPERIORITY||||||=|0.3043|||||||Chi-squared|||Anxiety disorders||||=0.3043
74079248|NCT04667338|147712038|SUPERIORITY||||||=|0.0885|||||||Chi-squared|||Panic disorder||||=0.0885
74079249|NCT04667338|147712038|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Phobia disorder||||=0.5603
74079250|NCT04667338|147712038|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Obsessive compulsive disorder||||=0.5603
74079251|NCT04667338|147712038|SUPERIORITY||||||=|0.3646|||||||Chi-squared|||Diagnosis of ADHD||||=0.3646
74079252|NCT04667338|147712038|SUPERIORITY||||||=|0.2615|||||||Chi-squared|||Obesity||||=0.2615
74079253|NCT04667338|147712038|SUPERIORITY||||||=|0.3076|||||||Chi-squared|||Endocrine Disorders||||=0.3076
74079254|NCT04667338|147712038|SUPERIORITY||||||=|0.409|||||||Chi-squared|||Peripheral vascular disease||||=0.4090
74079255|NCT04667338|147712038|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Cardiovascular accident or transient ischemic attack (TIA)||||=0.5603
74079256|NCT04667338|147712038|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||COPD||||=0.5603
74079257|NCT04667338|147712038|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Connective tissue disease||||=0.5603
74079258|NCT04667338|147712038|SUPERIORITY||||||=|0.7451|||||||Chi-squared|||Liver Disease||||=0.7451
74079259|NCT04667338|147712038|SUPERIORITY||||||=|0.3108|||||||Chi-squared|||Diabetes Mellitus||||=0.3108
74079260|NCT04667338|147712038|SUPERIORITY||||||=|0.2407|||||||Chi-squared|||Solid Tumor||||=0.2407
74079261|NCT04667338|147712038|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||AIDS||||=0.5603
74079262|NCT04667338|147712038|SUPERIORITY||||||=|0.1739|||||||Chi-squared|||Others||||=0.1739
74079263|NCT04667338|147712039|SUPERIORITY||||||=|0.3585|||||||t-test, 2 sided|||||||=0.3585
74079264|NCT03488108|147712049|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
74079265|NCT03488108|147712050|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||.90
74079266|NCT03488108|147712051|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||.003
74079267|NCT03488108|147712052|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||.005
74079268|NCT03503318|147712093|OTHER||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.109|0.367||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using the stratified Cox proportional hazard model, with treatment (placebo, TV-46000 q1m and TV-46000 q2m or placebo and TV-46000 overall \[including q1m and q2m\]) as explanatory variable and sex-dose as a stratification factor, and the stratified log rank test p-value (sex-dose as a stratification factor) referred to (TV-46000/placebo) comparison.||0.367|0.109|<0.0001
74079269|NCT03503318|147712093|OTHER||Hazard Ratio (HR)|0.375|||<|0.0001|TWO_SIDED|95.0|0.227|0.618||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using the stratified Cox proportional hazard model, with treatment (placebo, TV-46000 q1m and TV-46000 q2m or placebo and TV-46000 overall \[including q1m and q2m\]) as explanatory variable and sex-dose as a stratification factor, and the stratified log rank test p-value (sex-dose as a stratification factor) referred to (TV-46000/placebo) comparison.||0.618|0.227|<0.0001
74079270|NCT00834873|147712160|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.77||||||90.0|85.04|105.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.61|85.04|
74079271|NCT00834873|147712161|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.59|102.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.23|90.59|
74079272|NCT00834873|147712162|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.11||||||90.0|90.45|102.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.12|90.45|
74079273|NCT01125163|147712165|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0||||All infants were analyzed according to their assigned groups.|Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.||||0.59
74079274|NCT01125163|147712166|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.||||0.64
74079275|NCT03703258|147712167|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.26||0.6|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.60
73886373|NCT03773978|147306585|SUPERIORITY||Odds Ratio (OR)|1.17||||0.715|TWO_SIDED|95.0|0.5|2.75|||Regression, Logistic|||at week 24||2.75|0.50|0.715
74079276|NCT03703258|147712167|SUPERIORITY||Cohen's D|0.36|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
73886374|NCT03773978|147306585|SUPERIORITY||Odds Ratio (OR)|1.4||||0.384|TWO_SIDED|95.0|0.66|2.99|||Regression, Logistic|||at week 28||2.99|0.66|0.384
73886375|NCT03773978|147306585|SUPERIORITY||Odds Ratio (OR)|1.47||||0.311|TWO_SIDED|95.0|0.7|3.1|||Regression, Logistic|||at week 32||3.10|0.70|0.311
73888413|NCT02900378|147309622|OTHER|||||||0.5301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5301
74079277|NCT03703258|147712168|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.27||0.94|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.94
74079278|NCT03703258|147712168|SUPERIORITY||Cohen's D|-0.01|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
74079279|NCT03703258|147712169|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.38|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.38
74079280|NCT03703258|147712169|SUPERIORITY||Cohen's D|-0.15|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
74079281|NCT03703258|147712170|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.04
74079282|NCT03703258|147712170|SUPERIORITY||Cohen's D|-0.7|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
74079283|NCT03703258|147712171|SUPERIORITY||Slope|-1.23|STANDARD_ERROR_OF_MEAN|1.88||0.51|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.51
74079284|NCT03703258|147712171|SUPERIORITY||Slope|-0.9|STANDARD_ERROR_OF_MEAN|1.9||0.64|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.64
74079285|NCT03703258|147712171|SUPERIORITY||Cohen's D|-0.1|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
74079286|NCT03703258|147712171|SUPERIORITY||Cohen's D|0.02|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
74079287|NCT03703258|147712172|SUPERIORITY||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.3||0.04|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.04
74079288|NCT03703258|147712172|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.3||0.34|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.34
74079289|NCT03703258|147712172|SUPERIORITY||Cohen's D|0.92|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Positive values favor intervention and negative values favor control.|Baseline to post-intervention only||||
73886376|NCT03773978|147306585|SUPERIORITY||Odds Ratio (OR)|1.58||||0.231|TWO_SIDED|95.0|0.75|3.34|||Regression, Logistic|||at week 36||3.34|0.75|0.231
74079290|NCT03703258|147712172|SUPERIORITY||Cohen's D|0.68|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Positive values favor intervention and negative values favor control.|Baseline to 3 months||||
74079291|NCT03703258|147712173|SUPERIORITY||Slope|-2.46|STANDARD_ERROR_OF_MEAN|1.63||0.13|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.13
74079292|NCT03703258|147712173|SUPERIORITY||Slope|-1.94|STANDARD_ERROR_OF_MEAN|1.64||0.24|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.24
74079293|NCT03703258|147712173|SUPERIORITY||Cohen's D|-0.41|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
74079294|NCT03703258|147712173|SUPERIORITY||Cohen's D|-0.23|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
74079295|NCT03703258|147712174|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.25||0.85|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.85
74079296|NCT03703258|147712174|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.25||0.96|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.96
74079297|NCT03703258|147712174|SUPERIORITY||Cohen's D|-0.15|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
74079298|NCT03703258|147712174|SUPERIORITY||Cohen's D|0.003|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
74079299|NCT03703258|147712175|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.75|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.75
74079300|NCT03703258|147712175|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.27||0.64|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.64
74079301|NCT03703258|147712175|SUPERIORITY||Cohen's D|-0.12|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
74079302|NCT03703258|147712175|SUPERIORITY||Cohen's D|-0.16|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
74079303|NCT03703258|147712176|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.35||0.86|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.86
74079304|NCT03703258|147712176|SUPERIORITY||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.36||0.55|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.55
74079305|NCT03703258|147712176|SUPERIORITY||Cohen's D|-0.04|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
74079306|NCT03703258|147712176|SUPERIORITY||Cohen's D|-0.39|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
74079307|NCT02709018|147712179|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
74079308|NCT02709018|147712180|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|||||||0.57
74079309|NCT01494532|147712203|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||4mg/day vs Placebo||||0.814
74079310|NCT01494532|147712203|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||8 mg/day vs Placebo||||0.013
74079311|NCT01494532|147712203|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||12 mg/day vs Placebo||||0.287
74079312|NCT01494532|147712203|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||16 mg/day vs Placebo||||0.027
74079313|NCT01494532|147712203|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||24 mg/day vs Placebo||||0.390
74079314|NCT01494532|147712203|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||4mg/day vs Placebo||||0.844
74079315|NCT01494532|147712203|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||8 mg/day vs Placebo||||0.030
74079316|NCT01494532|147712203|SUPERIORITY_OR_OTHER|||||||0.437||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||12 mg/day vs Placebo||||0.437
74079317|NCT01494532|147712203|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||16 mg/day vs Placebo||||0.034
74079318|NCT01494532|147712203|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||24 mg/day vs Placebo||||0.808
74079319|NCT01494532|147712204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.826|TWO_SIDED|95.0|0.398|3.166|||Generalized Estimating Equations model|||||3.166|0.398|0.826
74079320|NCT01494532|147712204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.622||||0.233|TWO_SIDED|95.0|0.732|3.593|||Generalized Estimating Equations model|||||3.593|0.732|0.233
74079321|NCT01494532|147712204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.953||||0.902|TWO_SIDED|95.0|0.439|2.065|||Generalized Estimating Equations model|||||2.065|0.439|0.902
74079322|NCT01494532|147712204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.866||||0.127|TWO_SIDED|95.0|0.837|4.158|||Generalized Estimating Equations model|||||4.158|0.837|0.127
74079323|NCT01494532|147712204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.362||||0.564|TWO_SIDED|95.0|0.477|3.888|||Generalized Estimating Equations model|||||3.888|0.477|0.564
74079324|NCT01494532|147712205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.908||||0.861|TWO_SIDED|95.0|0.31|2.659|||Generalized Estimating Equations model|||||2.659|0.310|0.861
74079325|NCT01494532|147712205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.608||||0.277|TWO_SIDED|95.0|0.684|3.782|||Generalized Estimating Equations model|||||3.782|0.684|0.277
74079326|NCT01494532|147712205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.074||||0.869|TWO_SIDED|95.0|0.461|2.5|||Generalized Estimating Equations model|||||2.500|0.461|0.869
74079327|NCT01494532|147712205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.916||||0.14|TWO_SIDED|95.0|0.808|4.545|||Generalized Estimating Equations model|||||4.545|0.808|0.140
74079328|NCT01494532|147712205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.689||||0.362|TWO_SIDED|95.0|0.547|5.218|||Generalized Estimating Equations model|||||5.218|0.547|0.362
74079329|NCT01494532|147712206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.723||||0.525|TWO_SIDED|95.0|0.266|1.965|||Generalized Estimating Equations model|||||1.965|0.266|0.525
74079330|NCT01494532|147712206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.851||||0.13|TWO_SIDED|95.0|0.834|4.109|||Generalized Estimating Equations model|||||4.109|0.834|0.130
74079331|NCT01494532|147712206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.996||||0.992|TWO_SIDED|95.0|0.444|2.232|||Generalized Estimating Equations model|||||2.232|0.444|0.992
74079332|NCT01494532|147712206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.329|TWO_SIDED|95.0|0.674|3.248|||Generalized Estimating Equations model|||||3.248|0.674|0.329
74079333|NCT01494532|147712206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.907||||0.856|TWO_SIDED|95.0|0.315|2.61|||Generalized Estimating Equations model|||||2.610|0.315|0.856
74079334|NCT01494532|147712208|SUPERIORITY_OR_OTHER|||||||0.376|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.376
74079335|NCT01494532|147712208|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.036
74079336|NCT01494532|147712208|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.362
74079337|NCT01494532|147712208|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.089
74079338|NCT01494532|147712208|SUPERIORITY_OR_OTHER|||||||0.403|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.403
74079339|NCT01494532|147712209|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.419
74079340|NCT01494532|147712209|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
74079341|NCT01494532|147712209|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.230
74079342|NCT01494532|147712209|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.033
74079343|NCT01494532|147712209|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.266
74079344|NCT01494532|147712210|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.073
74079345|NCT01494532|147712210|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.996
74079346|NCT01494532|147712210|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.791
74079347|NCT01494532|147712210|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.747
74079348|NCT01494532|147712210|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.600
74079349|NCT01494532|147712211|SUPERIORITY_OR_OTHER|||||||0.998|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.998
74079350|NCT01494532|147712211|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.017
74079351|NCT01494532|147712211|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.312
74079352|NCT01494532|147712211|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.008
74079353|NCT01494532|147712211|SUPERIORITY_OR_OTHER|||||||0.659|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.659
74079354|NCT01494532|147712212|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.337
74079355|NCT01494532|147712212|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.126
74079356|NCT01494532|147712212|SUPERIORITY_OR_OTHER|||||||0.283|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.283
74079357|NCT01494532|147712212|SUPERIORITY_OR_OTHER|||||||0.148|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.148
74079358|NCT01494532|147712212|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.581
74079359|NCT01494532|147712213|SUPERIORITY_OR_OTHER|||||||0.486|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.486
74079360|NCT01494532|147712213|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
74079361|NCT01494532|147712213|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.121
74079362|NCT01494532|147712213|SUPERIORITY_OR_OTHER|||||||0.081|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.081
74079363|NCT01494532|147712213|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.187
74079364|NCT01494532|147712214|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.134
73886377|NCT03773978|147306585|SUPERIORITY||Odds Ratio (OR)|1.82||||0.129|TWO_SIDED|95.0|0.84|3.95|||Regression, Logistic|||at week 40||3.95|0.84|0.129
73886378|NCT03773978|147306585|SUPERIORITY||Odds Ratio (OR)|2.23||||0.043|TWO_SIDED|95.0|1.02|4.84|||Regression, Logistic|||at week 44||4.84|1.02|0.043
73886379|NCT03773978|147306586|SUPERIORITY||Odds Ratio (OR)|1.1||||0.853|TWO_SIDED|95.0|0.4|2.98|||Regression, Logistic|||at week 16||2.98|0.40|0.853
73886380|NCT03773978|147306586|SUPERIORITY||Odds Ratio (OR)|0.7||||0.432|TWO_SIDED|95.0|0.29|1.71|||Regression, Logistic|||at week 20||1.71|0.29|0.432
73886381|NCT03773978|147306586|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.41|2.31|||Regression, Logistic|||at week 24||2.31|0.41|0.960
73886382|NCT03773978|147306586|SUPERIORITY||Odds Ratio (OR)|1.71||||0.215|TWO_SIDED|95.0|0.73|4.01|||Regression, Logistic|||at week 28||4.01|0.73|0.215
73886383|NCT03773978|147306586|SUPERIORITY||Odds Ratio (OR)|1.8||||0.173|TWO_SIDED|95.0|0.77|4.22|||Regression, Logistic|||at week 32||4.22|0.77|0.173
73886384|NCT03773978|147306586|SUPERIORITY||Odds Ratio (OR)|1.46||||0.367|TWO_SIDED|95.0|0.64|3.33|||Regression, Logistic|||at week 36||3.33|0.64|0.367
73886385|NCT03773978|147306586|SUPERIORITY||Odds Ratio (OR)|1.9||||0.162|TWO_SIDED|95.0|0.77|4.67|||Regression, Logistic|||at week 40||4.67|0.77|0.162
73886386|NCT03773978|147306586|SUPERIORITY||Odds Ratio (OR)|1.96||||0.113|TWO_SIDED|95.0|0.85|4.5|||Regression, Logistic|||at week 44||4.50|0.85|0.113
73886387|NCT03773978|147306587|SUPERIORITY||Odds Ratio (OR)|0.8||||0.511|TWO_SIDED|95.0|0.42|1.55|||Regression, Logistic|||at week 16||1.55|0.42|0.511
73886388|NCT03773978|147306587|SUPERIORITY||Odds Ratio (OR)|1.64||||0.145|TWO_SIDED|95.0|0.84|3.2|||Regression, Logistic|||at week 20||3.20|0.84|0.145
73886389|NCT03773978|147306587|SUPERIORITY||Odds Ratio (OR)|1.38||||0.349|TWO_SIDED|95.0|0.7|2.72|||Regression, Logistic|||at week 24||2.72|0.70|0.349
73886390|NCT03773978|147306587|SUPERIORITY||Odds Ratio (OR)|1.63||||0.167|TWO_SIDED|95.0|0.82|3.25|||Regression, Logistic|||at week 28||3.25|0.82|0.167
73888414|NCT02900378|147309622|OTHER|||||||0.6019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.6019
73886391|NCT03773978|147306587|SUPERIORITY||Odds Ratio (OR)|1.55||||0.212|TWO_SIDED|95.0|0.78|3.07|||Regression, Logistic|||at week 32||3.07|0.78|0.212
73886392|NCT03773978|147306587|SUPERIORITY||Odds Ratio (OR)|1.21||||0.577|TWO_SIDED|95.0|0.62|2.39|||Regression, Logistic|||at week 36||2.39|0.62|0.577
73886393|NCT03773978|147306587|SUPERIORITY||Odds Ratio (OR)|1.51||||0.225|TWO_SIDED|95.0|0.78|2.95|||Regression, Logistic|||at week 40||2.95|0.78|0.225
73886394|NCT03773978|147306587|SUPERIORITY||Odds Ratio (OR)|1.96||||0.055|TWO_SIDED|95.0|0.98|3.9|||Regression, Logistic|||at week 44||3.90|0.98|0.055
73886395|NCT03773978|147306589|SUPERIORITY||LS Mean difference|-4.33|STANDARD_ERROR_OF_MEAN|1.328||0.001|TWO_SIDED|95.0|-6.95|-1.7|||ANCOVA|||||-1.70|-6.95|0.001
73886396|NCT03773978|147306590|SUPERIORITY||LS Mean difference|-12.97|STANDARD_ERROR_OF_MEAN|4.262||0.003|TWO_SIDED|95.0|-21.39|-4.55|||ANCOVA|||||-4.55|-21.39|0.003
73886397|NCT03773978|147306591|SUPERIORITY||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.526||0.574|TWO_SIDED|95.0|-2.62|1.91|||ANCOVA|||||1.91|-2.62|0.574
73886398|NCT03773978|147306592|SUPERIORITY||LS Mean difference|0.45|STANDARD_ERROR_OF_MEAN|0.348||0.208|TWO_SIDED|95.0|-0.26|1.15|||ANCOVA|||||1.15|-0.26|0.208
73886399|NCT03773978|147306593|SUPERIORITY||LS Mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.438||0.019|TWO_SIDED|95.0|-1.98|-0.19|||ANCOVA|||||-0.19|-1.98|0.019
73886400|NCT04659863|147306600|OTHER||Mean Difference (Net)|-33.25|||||TWO_SIDED|95.0|-59.17|-7.34||||||||-7.34|-59.17|
73886401|NCT02105740|147306622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|STANDARD_DEVIATION|1.178||0.034|TWO_SIDED|95.0|0.224|5.11|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) for both arms with a statistical power of 95%, significance level of 5%. Statistical analysis first compared the difference of means between hypnosis and control groups during three weeks.||5.110|0.224|0.034
73886402|NCT02105740|147306622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.66|STANDARD_DEVIATION|0.856||0.004|TWO_SIDED|95.0|1.253|6.08|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the second week in the hypnosis group.||6.080|1.253|0.004
73886403|NCT02105740|147306622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.25|STANDARD_DEVIATION|0.827||0|TWO_SIDED|95.0|2.918|7.582|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the third week in the hypnosis group.||7.582|2.918|0.000
73886404|NCT02105740|147306623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||||TWO_SIDED|||||||||Statistical analysis evaluated if the difference of averages of anxiety at the hypnosis and control groups in the third week.||||
73886405|NCT02105740|147306623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|||||||||Statistical analysis evaluated if the difference of averages of depression at the hypnosis and control groups in the third week.||||
73886406|NCT05452486|147306647|EQUIVALENCE|The purpose of this study was to evaluate whether the mean performance on auditory processing assessments differed depending on whether the tests were administered in Spanish or English.|Slope|-3.89|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Dichotic digits comparison||||<0.01
74079365|NCT01494532|147712214|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.768
74079366|NCT01494532|147712214|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.859
74079367|NCT01494532|147712214|SUPERIORITY_OR_OTHER|||||||0.903|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.903
73886407|NCT05452486|147306647|EQUIVALENCE|The purpose of this study was to evaluate whether the mean performance on auditory processing assessments differed depending on whether the tests were administered in Spanish or English.|Slope|5.18||||0.69|TWO_SIDED||||||Mixed Models Analysis|||Dichotic words comparison||||0.69
73886408|NCT02086175|147306652|SUPERIORITY||percent|48.0||||0.044|TWO_SIDED|90.0|31.0|66.0|||Fisher Exact|||"Patients will be accrued in a single stage design, with a goal accrual of 25 patients.~Assuming a 30% response rate with rituximab alone, if the true but unknown rate of CR or PR is 50% with the addition of Imprime PGG, the probability of observing 11 or more patients with a response is 0.79 with 0.098 one-sided type-I error.~Therefore a study with 25 patients, in which an observed response rate of 11/25 (44%) would be considered worthy of further consideration."||66|31|0.044
73886409|NCT04314284|147306669|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
73886410|NCT04314284|147306670|SUPERIORITY|||||||0.35|||||||Kruskal-Wallis|||||||0.35
73886411|NCT04314284|147306671|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
73886412|NCT04314284|147306675|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
73886413|NCT04314284|147306676|SUPERIORITY|||||||0.52|||||||Kruskal-Wallis|||||||0.52
73886414|NCT04314284|147306677|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
73886415|NCT04314284|147306680|OTHER|2-sided||||||0.71|||||||t-test, 2 sided|||||||0.71
73886416|NCT04314284|147306681|OTHER|2-sided||||||0.12|||||||t-test, 2 sided|||||||0.12
73886417|NCT04314284|147306683|SUPERIORITY|||||||0.66|||||||Kruskal-Wallis|||||||0.66
73888415|NCT02900378|147309622|OTHER|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.8229
73888416|NCT02900378|147309622|OTHER|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.8229
73888417|NCT02900378|147309623|OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0001
73888418|NCT02900378|147309623|OTHER|||||||0.0123|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0123
74079368|NCT01494532|147712214|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.470
74079369|NCT01494532|147712215|SUPERIORITY_OR_OTHER|||||||0.822|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.822
74079370|NCT01494532|147712215|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.025
74079371|NCT01494532|147712215|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.267
74079372|NCT01494532|147712215|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
73886418|NCT02201953|147306703|NON_INFERIORITY_OR_EQUIVALENCE|Primary analyses consisted of non-inferiority test of Group 1 (SOF/VEL 12 weeks) versus Group 2 (SOF+RBV 24 weeks) at the 0.05 significance level. Non-inferiority was assessed using the conventional confidence interval approach and a non-inferiority margin of 10% was applied. The two-sided 95% confidence intervals was constructed using stratum-adjusted Mantel-Haenszel proportions, stratified by the randomization stratification factors (i.e cirrhosis status and prior treatment experience)|Difference in proportions|14.4|||||TWO_SIDED|95.0|9.2|19.6|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||19.6|9.2|
73886419|NCT02201953|147306703|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value was from the Cochran-Mantel-Haenszel test stratified by cirrhosis status and prior HCV treatment experience.|Cochran-Mantel-Haenszel|||If the lower bound of 95% CI on the difference was \> -10%, the p-value tested for the superiority of SOF/VEL for 12 weeks over SOF+RBV for 24 weeks. Superiority was demonstrated if the two-sided p-value is less than 0.05.||||<0.001
74079373|NCT01494532|147712215|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.458
74079374|NCT01494532|147712216|SUPERIORITY_OR_OTHER|||||||0.734|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.734
74079375|NCT01494532|147712216|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.048
73886420|NCT02892344|147306745|SUPERIORITY||Mean Difference (Net)|0.182|||<|0.001|TWO_SIDED|95.0|0.148|0.217|||Mixed Models Analysis|||||0.217|0.148|<0.001
73886421|NCT02892344|147306746|SUPERIORITY||Mean Difference (Net)|-0.218|||<|0.001|TWO_SIDED|95.0|-0.293|-0.143|||Mixed Models Analysis|||||-0.143|-0.293|<0.001
73886422|NCT02892344|147306747|SUPERIORITY||Mean Difference (Net)|0.132|||<|0.001|TWO_SIDED|95.0|0.105|0.158|||Mixed Models Analysis|||||0.158|0.105|<0.001
74079376|NCT01494532|147712216|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.443
74079377|NCT01494532|147712216|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.123
73886423|NCT02892344|147306748|SUPERIORITY||Mean Difference (Net)|0.176|||<|0.001|TWO_SIDED|95.0|0.145|0.207|||Mixed Models Analysis|||||0.207|0.145|<0.001
73886424|NCT02892344|147306749|SUPERIORITY||Mean Difference (Net)|0.1|||<|0.001|TWO_SIDED|95.0|0.061|0.139|||Mixed Models Analysis|||Pre-dose trough FVC||0.139|0.061|<0.001
73886425|NCT02892344|147306749|SUPERIORITY||Mean Difference (Net)|0.288|||<|0.001|TWO_SIDED|95.0|0.231|0.345|||Mixed Models Analysis|||Pre-dose trough FEF25-75%||0.345|0.231|<0.001
73886426|NCT02892344|147306750|SUPERIORITY||Mean Difference (Net)|27.2|||<|0.001|TWO_SIDED|95.0|22.1|32.4|||Mixed Models Analysis|||Mean Morning PEF||32.4|22.1|<0.001
73886427|NCT02892344|147306750|SUPERIORITY||Mean Difference (Net)|26.1|||<|0.001|TWO_SIDED|95.0|21.0|31.2|||Mixed Models Analysis|||Mean Evening PEF||31.2|21.0|<0.001
73886428|NCT02892344|147306753|SUPERIORITY||Mean Difference (Net)|-0.204|||<|0.001|TWO_SIDED|95.0|-0.277|-0.131|||Mixed Models Analysis|||||-0.131|-0.277|<0.001
73888419|NCT02900378|147309623|OTHER|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.2560
73886429|NCT02892344|147306754|SUPERIORITY||Mean Difference (Net)|-0.11|||<|0.001|TWO_SIDED|95.0|-0.16|-0.05|||Mixed Models Analysis|||Night-time number of puffs of rescue medication||-0.05|-0.16|<0.001
73886430|NCT02892344|147306754|SUPERIORITY||Mean Difference (Net)|-0.15|||<|0.001|TWO_SIDED|95.0|-0.22|-0.08|||Mixed Models Analysis|||Daytime number of puffs of rescue medication||-0.08|-0.22|<0.001
74079378|NCT01494532|147712216|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.641
74079379|NCT01494532|147712217|SUPERIORITY_OR_OTHER|||||||0.822|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.822
74079380|NCT01494532|147712217|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.025
74079381|NCT01494532|147712217|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.267
74079382|NCT01494532|147712217|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
74079383|NCT01494532|147712217|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.458
74079384|NCT01494532|147712218|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.814
74079385|NCT01494532|147712218|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.013
74079386|NCT01494532|147712218|SUPERIORITY_OR_OTHER|||||||0.287|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.287
74079387|NCT01494532|147712218|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.027
74079388|NCT01494532|147712218|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.390
74079389|NCT01494532|147712219|SUPERIORITY_OR_OTHER|||||||0.376|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.376
74079390|NCT01494532|147712219|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.036
74079391|NCT01494532|147712219|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.362
74079392|NCT01494532|147712219|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.089
74079393|NCT01494532|147712219|SUPERIORITY_OR_OTHER|||||||0.403|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.403
74079394|NCT01494532|147712220|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.419
74079395|NCT01494532|147712220|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
74079396|NCT01494532|147712220|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.230
74079397|NCT01494532|147712220|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.033
73886431|NCT02892344|147306755|SUPERIORITY||Mean Difference (Net)|8.1|||<|0.001|TWO_SIDED|95.0|4.3|11.8|||Mixed Models Analysis|||||11.8|4.3|<0.001
73886432|NCT02892344|147306756|SUPERIORITY||Mean Difference (Net)|0.149|||<|0.001|TWO_SIDED|95.0|0.064|0.234|||Mixed Models Analysis|||||0.234|0.064|<0.001
73886433|NCT02892344|147306759|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.14|0.59|||Regression, Cox|||||0.59|0.14|<0.001
73888420|NCT02900378|147309623|OTHER|||||||0.5865|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.5865
74079398|NCT01494532|147712220|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.266
74079399|NCT01494532|147712221|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.073
74079400|NCT01494532|147712221|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.996
74079401|NCT01494532|147712221|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.791
74079402|NCT01494532|147712221|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.747
74079403|NCT01494532|147712221|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.600
74079404|NCT01494532|147712222|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.007
74079405|NCT01494532|147712222|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.014
74079406|NCT01494532|147712222|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.016
73886434|NCT01074814|147306760|OTHER||||||||||||||||||Results for the primary objective - evaluation of GMI - were presented with descriptive statistics as the ration of PFS on current therapy over the PFS on latest therapy. The percentage of patients with GMI greater than 1.3 was displayed along with its corresponding 95% exact confidence interval.|||
74079407|NCT01494532|147712222|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.005
74079408|NCT01494532|147712222|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.008
74079409|NCT01494532|147712223|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.047
74079410|NCT01494532|147712223|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.005
74079411|NCT01494532|147712223|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.172
74079412|NCT01494532|147712223|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.034
74079413|NCT01494532|147712223|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
74079414|NCT01494532|147712224|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.292
74079415|NCT01494532|147712224|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.068
74079416|NCT01494532|147712224|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.170
74079417|NCT01494532|147712224|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.003
74079418|NCT01494532|147712224|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.153
74079419|NCT01494532|147712225|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.409
74079420|NCT01494532|147712225|SUPERIORITY_OR_OTHER|||||||0.598|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.598
74079421|NCT01494532|147712225|SUPERIORITY_OR_OTHER|||||||0.992|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.992
74079422|NCT01494532|147712225|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.169
74079423|NCT01494532|147712225|SUPERIORITY_OR_OTHER|||||||0.348|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.348
74079424|NCT04517604|147712248|SUPERIORITY||Mean Difference (Final Values)|-5.02|STANDARD_DEVIATION|4.984||0.343|TWO_SIDED|95.0|-16.52|6.47||no adjustment for multiple comparisons as was a pilot|Mixed Models Analysis|||||6.47|-16.52|.343
74079425|NCT04517604|147712249|SUPERIORITY|This was a pilot study funded under a pilot funding mechanism which specifically did not require a power analysis.|Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|0.42||0.0026|TWO_SIDED|95.0|-2.63|-0.77||no test for multiple comparisons as this was a pilot study|Mixed Models Analysis|||This was an open-label, single group study using a within subject design. We compared pre-treatment values to post-treatment values.||-.77|-2.63|.0026
74079426|NCT02635750|147712272|OTHER||Adjusted gMean ratio(%)|99.95|||||TWO_SIDED|90.0|89.502|111.62|||||"Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+ don / BI 409306).~Intra-individual coefficient of variation (gCV (%)) = 18.6."|"The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||111.62|89.502|
74079427|NCT02635750|147712273|OTHER||Adjusted gMean ratio(%)|100.82|||||TWO_SIDED|90.0|81.861|124.17|||||Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+don / BI 409306). Intra-individual coefficient of variation (gCV (%)) = 35.8.|"The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||124.17|81.861|
74079428|NCT02635750|147712274|OTHER||Adjusted gMean ratio (%)|100.84|||||TWO_SIDED|90.0|97.584|104.19|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone (BI 409306+don / don). Intra-individual coefficient of variation (gCV (%)) = 4.9.|The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Abbreviations used: geometric mean (gMean), donepezil (don)||104.19|97.584|
74079429|NCT02635750|147712275|OTHER||Adjusted gMean ratio(%)|113.08|||||TWO_SIDED|90.0|106.41|120.15|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone. (BI 409306+don / don) Intra-individual coefficient of variation (gCV (%)) = 9.0.|"The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||120.15|106.41|
74079430|NCT02635750|147712276|OTHER||Adjusted gMean ratio(%)|100.01|||||TWO_SIDED|90.0|89.549|111.68|||||Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+don/ BI 409306). Intra-individual coefficient of variation (gCV(%)) = 18.6.|The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed. Abbreviations used: geometric mean (gMean), donepezil (don)||111.68|89.549|
73886435|NCT03591406|147306761|NON_INFERIORITY|Pre-defined non-inferiority margin of -15%|Difference in proportions|1.12|||||TWO_SIDED|95.0|-2.15|4.71|||||2-sided 95% Confidence Interval (CI) was computed using the Wilson score method with continuity correction described by Newcombe.|||4.71|-2.15|
74079431|NCT02635750|147712277|OTHER||Adjusted gMean ratio(%)|98.38|||||TWO_SIDED|90.0|93.413|103.6|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone (BI 409306+don / don). Intra-individual coefficient of variation (gCV (%)) = 7.7.|"The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||103.60|93.413|
74079432|NCT00830258|147712286|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|105.76||||||90.0|98.17|113.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||113.93|98.17|
74079433|NCT00830258|147712287|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.45||||||90.0|104.31|116.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||116.96|104.31|
74079434|NCT00830258|147712288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.61||||||90.0|104.39|117.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||117.20|104.39|
74079435|NCT05511935|147712410|SUPERIORITY||Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|3.69||0.64|TWO_SIDED|95.0|-5.57|9.06|||t-test, 2 sided|||||9.06|-5.57|0.64
74079436|NCT05511935|147712411|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.81||0.47|TWO_SIDED|95.0|-2.28|4.89|||t-test, 2 sided|||||4.89|-2.28|0.47
73886436|NCT02066181|147306775|SUPERIORITY||Hazard Ratio (HR)|11.3|||<|0.001|ONE_SIDED|95.0|5.7||||Log Rank||||||5.7|<0.001
74079437|NCT05511935|147712412|SUPERIORITY||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|4.25||0.59|TWO_SIDED|95.0|-10.77|6.11|||t-test, 2 sided|||||6.11|-10.77|0.59
74079438|NCT05511935|147712413|SUPERIORITY||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|5.53||0.77|TWO_SIDED|95.0|-12.61|9.38|||t-test, 2 sided|||||9.38|-12.61|0.77
74079439|NCT05511935|147712414|SUPERIORITY||Mean Difference (Final Values)|-12.21|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-17.95|-6.47|||t-test, 2 sided|||||-6.47|-17.95|<0.001
74079440|NCT05511935|147712415|SUPERIORITY||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|1.87||0.39|TWO_SIDED|95.0|-2.1|5.34|||t-test, 2 sided|||||5.34|-2.10|0.39
74079441|NCT05511935|147712416|SUPERIORITY||Mean Difference (Final Values)|-8.88|STANDARD_ERROR_OF_MEAN|2.84|<|0.01|TWO_SIDED|95.0|-14.52|-3.24|||t-test, 2 sided|||||-3.24|-14.52|<0.01
74079442|NCT05511935|147712417|SUPERIORITY||Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|4.06||0.49|TWO_SIDED|95.0|-10.9|5.23|||t-test, 2 sided|||||5.23|-10.90|0.49
74079443|NCT05511935|147712419|SUPERIORITY||Slope|7.71|STANDARD_ERROR_OF_MEAN|5.28||0.15|TWO_SIDED|95.0|-2.92|18.35|||Regression, Linear|||||18.35|-2.92|0.15
74079444|NCT05511935|147712420|SUPERIORITY||Slope|0.43|STANDARD_ERROR_OF_MEAN|4.19||0.92|TWO_SIDED|95.0|-8.13|8.99|||Regression, Linear|||||8.99|-8.13|0.92
73888421|NCT02900378|147309623|OTHER|||||||0.5463|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.5463
73888422|NCT02900378|147309623|OTHER|||||||0.3212|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.3212
73888423|NCT02900378|147309624|OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0004
73886437|NCT02851615|147306809|SUPERIORITY|Power analyses were calculated on the PAM-13, our primary outcome measure. Analyses were conducted using the internal Monte Carlo simulation capabilities of Mplus (Version 1.20). Based on the effect size obtained from published pilot data, we expected the change in baseline/posttreatment Behavioral Activation for the SCThrive intervention group to be n2 = .14 (large effect). Based on these assumptions, the desired sample size was 54 participants (N = 27 per group) to achieve power of .80.|Mean Difference (Net)|7.75|STANDARD_ERROR_OF_MEAN|13.14||0.09|TWO_SIDED|95.0|-1.27|19.22||The threshold for statistical significance was p =.05|ANCOVA|||We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the PAM-13.||19.22|-1.27|.09
73886438|NCT02851615|147306810|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.55||0.28|TWO_SIDED|95.0|-0.19|0.66||The threshold for significance was p =.05|ANCOVA|||We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the TRAQ-5||.66|-.19|.28
73886439|NCT02851615|147306811|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.13||0.27|TWO_SIDED|95.0|-0.018|0.06||The threshold for statistical significance was p =.05|t-test, 2 sided|||We conducted a paired-samples t-test to assess for the effects of time (baseline/post-treatment) for participants (n=16) in the SCThrive intervention arm for the UNC TRxANSITION Scale.||.06|-.018|.27
73886440|NCT05764785|147306813|SUPERIORITY|||||||0.182||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.182
74079445|NCT05511935|147712421|SUPERIORITY||Slope|7.66|STANDARD_ERROR_OF_MEAN|5.81||0.2|TWO_SIDED|95.0|-4.17|19.49|||Regression, Linear|||||19.49|-4.17|0.20
73886441|NCT05764785|147306814|SUPERIORITY|||||||0.461||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.461
73888424|NCT02900378|147309624|OTHER|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0009
73886442|NCT05764785|147306815|SUPERIORITY|||||||0.228||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.228
74079446|NCT05511935|147712422|SUPERIORITY||Slope|-9.29|STANDARD_ERROR_OF_MEAN|10.74||0.39|TWO_SIDED|95.0|-31.15|12.56|||Regression, Linear|||||12.56|-31.15|0.39
73886443|NCT05764785|147306816|SUPERIORITY|||||||0.295||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.295
73886444|NCT05764785|147306817|SUPERIORITY|||||||0.915||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.915
73886445|NCT05764785|147306818|SUPERIORITY|||||||0.226||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.226
73886446|NCT01391546|147306876|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was achieved if the lower bound of the 2-sided 95% confidence interval (CI) for the GMT ratio was greater than 2/3|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.93|1.18|||longitudinal regression model|Model adjusted for pre-vaccination titres and age at vaccination in years|GMT ratio = GMT IM route divided by GMT SC route|||1.18|0.93|<0.001
73886447|NCT01391546|147306877|SUPERIORITY_OR_OTHER||GMFR|2.7|||||TWO_SIDED|95.0|2.4|3.0|||||GMFR = GMT Post-vaccination/GMT Pre-vaccination|Acceptability was demonstrated if the lower bound of the two-sided 95% CI was \>1.4||3.0|2.4|
74079447|NCT05090839|147712430|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|variance explained by the IV.|0.072|||<|0.05|TWO_SIDED|95.0|0.0|0.234|||ANOVA|||||.234|.0000|<0.05
73886448|NCT01353898|147306928|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.62|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 200 mg MK-1972 once daily||||
73888425|NCT02900378|147309624|OTHER|||||||0.0094|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0094
74079448|NCT05090839|147712432|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|Mean Difference (Final Values)|0.358|||<|0.05|TWO_SIDED|95.0|0.0|0.554|||ANOVA|||This is a comparison that is specific to the contrast of visualizing traumatic versus stressful events.||.554|0|<0.05
74079449|NCT05090839|147712433|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|Mean Difference (Final Values)|0.51|||<|0.05|TWO_SIDED|95.0|0.0|0.676|||ANOVA|||||.676|.000|<0.05
74079450|NCT03913377|147712438|EQUIVALENCE|A statistically significant difference in NIBUT/NIKBUT between Test lens and Spectacles was concluded if the upper confidence limit of the 95% CI is below zero or the lower limit is above zero.|LS Mean Difference|-2.79|STANDARD_ERROR_OF_MEAN|0.678|||TWO_SIDED|95.0|-4.14|-1.44|||Mixed Model Analysis|Kenward and Roger method was used for denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|The null and alternative hypotheses for testing significant difference between Test lens and Spectacles among habitual lens users with respect to NIBUT/NIKBUT.||-1.44|-4.14|
74079451|NCT03913377|147712439|OTHER|Estimated 95% confidence intervals for the point estimates of Test and Control|Mean Proportion|85.59|STANDARD_ERROR_OF_MEAN|1.038|||TWO_SIDED|95.0|43.2|97.89|||Mixed Model Analysis|||Point estimates for Test and Control with 95% confidence intervals||97.89|43.2|
74079452|NCT03913377|147712439|OTHER|Estimated 95% confidence intervals for the point estimates of Test and Control|Mean Proportion|84.17|STANDARD_ERROR_OF_MEAN|0.871|||TWO_SIDED|95.0|48.67|96.75|||Mixed Model Analysis|||Point estimates for Test and Control with 95% confidence intervals||96.75|48.67|
74079453|NCT03913377|147712440|OTHER|Estimated 95% confidence intervals for the point estimates of test.|Mean|0.52|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|0.4|0.65|||Mixed Model Analysis|Kenward and Rogers Metod was used for degrees of freedom|||Point estimate was calculated for Test.|0.65|0.40|
74079454|NCT03913377|147712440|OTHER|Estimated 95% confidence intervals for the point estimates of Control.|Mean|0.13|STANDARD_ERROR_OF_MEAN|0.036|||TWO_SIDED|95.0|-0.19|0.44|||Mixed Model Analysis|Kenward and Rogers Metod was used for degrees of freedom|||Point estimates were calculated for Control.|0.44|-0.19|
74079455|NCT03913377|147712441|OTHER|Estimated 95% confidence intervals for the point estimates of Test.|Mean Proportion|30.7|STANDARD_ERROR_OF_MEAN|19.87|||TWO_SIDED|95.0|6.5|73.8|||Mixed Model Analysis||Point estimates were calculated for Test|||73.8|6.5|
74079456|NCT03913377|147712441|OTHER|Estimated 95% confidence intervals for the point estimates of Control.|Mean Proportion|27.9|STANDARD_ERROR_OF_MEAN|18.17|||TWO_SIDED|95.0|6.1|69.8|||Mixed Model Analysis||Point estimates were calculated for Control.|||69.8|6.1|
74079457|NCT01592240|147712503|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.28|||<|0.001|TWO_SIDED|95.0|-45.06|-23.5|||Mixed models repeated measures analysis|||||-23.50|-45.06|<0.001
74079458|NCT01592240|147712503|SUPERIORITY_OR_OTHER||Adjusted mean difference|-45.07|||<|0.001|TWO_SIDED|95.0|-55.93|-34.21|||Mixed models repeated measures analysis|||||-34.21|-55.93|<0.001
74079459|NCT01592240|147712503|SUPERIORITY_OR_OTHER||Adjusted mean difference|-53.42|||<|0.001|TWO_SIDED|95.0|-64.14|-42.7|||Mixed models repeated measures analysis|||||-42.70|-64.14|<0.001
74079460|NCT01592240|147712503|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.58|||<|0.001|TWO_SIDED|95.0|-40.49|-14.67|||Mixed models repeated measures analysis|||||-14.67|-40.49|<0.001
74079461|NCT01592240|147712503|SUPERIORITY_OR_OTHER||Adjusted mean difference|-44.85|||<|0.001|TWO_SIDED|95.0|-57.65|-32.05|||Mixed models repeated measures analysis|||||-32.05|-57.65|<0.001
74079462|NCT01592240|147712504|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.41|||<|0.001|TWO_SIDED|95.0|-39.15|-17.67|||Mixed models repeated measures analysis|||||-17.67|-39.15|<0.001
74079463|NCT01592240|147712504|SUPERIORITY_OR_OTHER||Adjusted mean difference|-43.21|||<|0.001|TWO_SIDED|95.0|-53.9|-32.51|||Mixed models repeated measures analysis|||||-32.51|-53.90|<0.001
74079464|NCT01592240|147712504|SUPERIORITY_OR_OTHER||Adjusted mean difference|-41.03|||<|0.001|TWO_SIDED|95.0|-51.66|-30.41|||Mixed models repeated measures analysis|||||-30.41|-51.66|<0.001
74079465|NCT01592240|147712504|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.77|||<|0.001|TWO_SIDED|95.0|-33.7|-13.84|||Mixed models repeated measures analysis|||||-13.84|-33.70|<0.001
74079466|NCT01592240|147712504|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.36|||<|0.001|TWO_SIDED|95.0|-40.24|-20.49|||Mixed models repeated measures analysis|||||-20.49|-40.24|<0.001
74079467|NCT01592240|147712505|SUPERIORITY_OR_OTHER||Adjusted mean difference|-35.0|||<|0.001|TWO_SIDED|95.0|-44.91|-25.1|||Mixed models repeated measures analysis|||Week 12||-25.10|-44.91|<0.001
74079468|NCT01592240|147712505|SUPERIORITY_OR_OTHER||Adjusted mean difference|-42.32|||<|0.001|TWO_SIDED|95.0|-52.3|-32.33|||Mixed models repeated measures analysis|||Week 12||-32.33|-52.30|<0.001
74079469|NCT01592240|147712505|SUPERIORITY_OR_OTHER||Adjusted mean difference|-53.12|||<|0.001|TWO_SIDED|95.0|-62.97|-43.27|||Mixed models repeated measures analysis|||Week 12||-43.27|-62.97|<0.001
74079470|NCT01592240|147712505|SUPERIORITY_OR_OTHER||Adjusted mean difference|-26.96|||<|0.001|TWO_SIDED|95.0|-38.25|-15.67|||Mixed models repeated measures analysis|||Week 12||-15.67|-38.25|<0.001
73888426|NCT02900378|147309624|OTHER|||||||0.0301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0301
73886449|NCT01353898|147306928|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.84|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 800 mg MK-1972 once daily||||
73886450|NCT01353898|147306929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||||||||||||||||
73886451|NCT01353898|147306929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||||||||||||||||
73886452|NCT01353898|147306929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||||||||||||||||
73886453|NCT01353898|147306929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||||||||||||||||
73886454|NCT01353898|147306929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.83||||||||||||||||||
73888427|NCT02900378|147309624|OTHER|||||||0.1557|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.1557
73888428|NCT02900378|147309624|OTHER|||||||0.6461|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.6461
73886455|NCT05386329|147306969|SUPERIORITY|Comparison of mid-treatment to end-of-treatment|Mean Difference (Final Values)|1.0308|STANDARD_ERROR_OF_MEAN|0.5485|=|0.0719|TWO_SIDED|95.0|-0.09883|2.1605||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CSQ-8 score compared to the end-point (week 8) CSQ-8 score.|Null hypothesis: there is no significant difference in CSQ-8 total scores between midpoint (week 4) and end-of-treatment (week 8).||2.1605|-0.09883|=.0719
73888429|NCT02900378|147309624|OTHER|||||||0.9759|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.9759
73888430|NCT02900378|147309624|OTHER|||||||0.3941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3941
73888431|NCT02900378|147309624|OTHER|||||||0.7209|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.7209
73888432|NCT02900378|147309624|OTHER|||||||0.4444|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4444
73888433|NCT02900378|147309624|OTHER|||||||0.7247|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.7247
73888434|NCT02900378|147309624|OTHER|||||||0.2933|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.2933
73888435|NCT02900378|147309625|OTHER|||||||0.0854|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0854
73888436|NCT02900378|147309625|OTHER|||||||0.0528|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0528
73888437|NCT02900378|147309625|OTHER|||||||0.4137|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.4137
73888438|NCT02900378|147309625|OTHER|||||||0.0082|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0082
73886456|NCT05386329|147306970|SUPERIORITY|Comparison of mid-treatment (week 4) to baseline|Mean Difference (Final Values)|0.4296|STANDARD_ERROR_OF_MEAN|0.8857|=|0.6316|TWO_SIDED|95.0|-1.3884|2.2475||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CEQ credibility score compared to the baseline (week 0) CEQ credibility score.|Null hypothesis: there is no significant difference in treatment credibility total scores between baseline (week 0) and midpoint (week 4).||2.2475|-1.3884|=.6316
73886457|NCT05386329|147306971|SUPERIORITY|Comparison of mid-treatment (week 4) to baseline.|Mean Difference (Final Values)|1.1512|STANDARD_ERROR_OF_MEAN|0.9213|=|0.2225|TWO_SIDED|95.0|-0.7422|3.0446||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CEQ expectancy scores compared to the baseline (week 0) CEQ expectancy scores.|Null hypothesis: there is no significant difference in treatment expectancy total scores between baseline (week 0) and midpoint (week 4).||3.0446|-0.7422|=.2225
73886458|NCT05386329|147306973|SUPERIORITY|Comparison of post-treatment (week 8) to mid-treatment (week 4)|Wilcoxon Z|0.2712|||=|0.7873|TWO_SIDED|||||The a priori threshold for statistical significance was alpha=.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no significant difference in treatment utilization between midpoint (week 4) and end of treatment (week 8).||||=.7873
73886459|NCT05386329|147306974|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|-7.8424|STANDARD_ERROR_OF_MEAN|1.2858|<|0.0001|TWO_SIDED|95.0|-10.4944|-5.1903||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) HAM-D score compared to the baseline (week 0) HAM-D score.|Null hypothesis: there is no significant difference in HAM-D total scores between baseline (week 0) and end of treatment (week 8).||-5.1903|-10.4944|<.0001
73886460|NCT05386329|147306975|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|-9.9409|STANDARD_ERROR_OF_MEAN|1.7329|<|0.0001|TWO_SIDED|95.0|-13.5043|-6.3776||The p-value was not adjusted for multiple comparisons because this was the pre-specified secondary outcome that addresses complementary aspects of the patient experience. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) WSAS scores compared to the baseline (week 0) WSAS scores.|Null hypothesis: there is no significant difference in WSAS total scores between baseline (week 0) and end of treatment (week 8).||-6.3776|-13.5043|<.0001
73886461|NCT05386329|147306976|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|21.5463|STANDARD_ERROR_OF_MEAN|3.4152|<|0.0001|TWO_SIDED|95.0|14.512|28.5806||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary outcome assessing a complementary aspect of the patient experience. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) Q-LES-Q-SF percent scores compared to the baseline (week 0) Q-LES-Q-SF percent scores.|Null hypothesis: there is no significant difference in Q-LES-Q-SF total scores between baseline (week 0) and end of treatment (week 8).||28.5806|14.5120|<.0001
73886462|NCT04408989|147307027|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.943|||||TWO_SIDED|90.0|0.899|0.989|||||For the comparison, MB02 SP represents the numerator and MB02 DM represents the denominator.|||0.989|0.899|
73886463|NCT04408989|147307027|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.0|||||TWO_SIDED|90.0|0.956|1.05|||||For the comparison, MB02 SP represents the numerator and US Avastin represents the denominator.|||1.05|0.956|
73888439|NCT02900378|147309625|OTHER|||||||0.7908|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.7908
73886464|NCT04408989|147307027|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.07|||||TWO_SIDED|90.0|1.01|1.12|||||For the comparison, MB02 DM represents the numerator and US Avastin represents the denominator.|||1.12|1.01|
73886465|NCT04408989|147307028|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.937|||||TWO_SIDED|90.0|0.887|0.989|||||For the comparison, MB02 SP represents the numerator and MB02 DM represents the denominator.|||0.989|0.887|
73888440|NCT02900378|147309625|OTHER|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.6499
73888441|NCT02900378|147309625|OTHER|||||||0.5547|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.5547
73888442|NCT02900378|147309625|OTHER|||||||0.6961|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.6961
73888443|NCT02900378|147309625|OTHER|||||||0.5946|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5946
73888444|NCT02900378|147309625|OTHER|||||||0.8957|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.8957
73888445|NCT02900378|147309625|OTHER|||||||0.8468|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.8468
73888446|NCT02900378|147309625|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1711
73888447|NCT02900378|147309626|OTHER|||||||0.0065|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0065
73888448|NCT02900378|147309626|OTHER|||||||0.0316|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0316
73888449|NCT02900378|147309626|OTHER|||||||0.1342|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.1342
73886466|NCT04408989|147307028|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.983|||||TWO_SIDED|90.0|0.925|1.05|||||For the comparison, MB02 SP represents the numerator and US Avastin represents the denominator.|||1.05|0.925|
73888450|NCT02900378|147309626|OTHER|||||||0.0252|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0252
73888451|NCT02900378|147309626|OTHER|||||||0.9024|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.9024
73888452|NCT02900378|147309626|OTHER|||||||0.9052|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.9052
73888453|NCT02900378|147309626|OTHER|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.2870
73888454|NCT02900378|147309626|OTHER|||||||0.3174|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3174
73888455|NCT02900378|147309626|OTHER|||||||0.502|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5020
73888456|NCT02900378|147309626|OTHER|||||||0.4037|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4037
73888457|NCT02900378|147309626|OTHER|||||||0.4823|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.4823
73888458|NCT02900378|147309626|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1090
73886467|NCT04408989|147307028|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.05|||||TWO_SIDED|90.0|0.991|1.11|||||For the comparison, MB02 DM represents the numerator and US Avastin represents the denominator.|||1.11|0.991|
73886468|NCT04363320|147307060|SUPERIORITY||Slope|0.538|STANDARD_DEVIATION|0.169||0.002|TWO_SIDED|||||a prior threshold 0.05|Mixed Models Analysis||Slope is per month|Change in new patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)||||0.002
73886469|NCT04363320|147307060|SUPERIORITY||Slope|0.38|STANDARD_DEVIATION|0.113||0.0008|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)||||0.0008
73886470|NCT04363320|147307060|SUPERIORITY||Slope|0.207|STANDARD_DEVIATION|0.129||0.111|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Methadone) for Intervention Phase (from baseline to 12 months)||||0.111
73886471|NCT04363320|147307060|SUPERIORITY||Slope|0.017|STANDARD_DEVIATION|0.014||0.235|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)||||0.235
73886472|NCT04363320|147307061|SUPERIORITY||Slope|0.153|STANDARD_DEVIATION|0.218||0.485|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month|Change in new patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)||||0.485
73886473|NCT04363320|147307061|SUPERIORITY||Slope|0.642|STANDARD_DEVIATION|0.19||0.0008|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new Justice Involved Person counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)||||0.0008
73886474|NCT04363320|147307061|SUPERIORITY||Slope|-0.377|STANDARD_DEVIATION|0.154||0.015|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Methadone) for Sustainability Phase (from 13 to 24 months)||||0.015
73886475|NCT04363320|147307061|SUPERIORITY||Slope|-0.02|STANDARD_DEVIATION|0.017||0.241|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)||||0.241
73886476|NCT04363320|147307062|SUPERIORITY||Slope|1.912|STANDARD_DEVIATION|0.438||2e-05|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)||||0.00002
73886477|NCT04363320|147307062|SUPERIORITY||Slope|0.855|STANDARD_DEVIATION|0.206||4e-05|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)||||0.00004
73886478|NCT04363320|147307062|SUPERIORITY||Slope|0.322|STANDARD_DEVIATION|0.206||0.118|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Methadone) for Intervention Phase (from baseline to 12 months)||||0.118
73886479|NCT04363320|147307062|SUPERIORITY||Slope|0.073|STANDARD_DEVIATION|0.031||0.02|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)||||0.020
73886480|NCT04363320|147307063|SUPERIORITY||Slope|0.617|STANDARD_DEVIATION|0.307||0.045|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)||||0.045
73886481|NCT04363320|147307063|SUPERIORITY||Slope|1.103|STANDARD_DEVIATION|0.229||2e-06|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)||||0.000002
73886482|NCT04363320|147307063|SUPERIORITY||Slope|-0.387|STANDARD_DEVIATION|0.218||0.076|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month|Change in census patient counts (Methadone) for Sustainability Phase (13 to 24 months)||||0.076
73886483|NCT04363320|147307063|SUPERIORITY||Slope|0.086|STANDARD_DEVIATION|0.036||0.019|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)||||0.019
73886484|NCT04672239|147307069|SUPERIORITY||Mean Difference (Final Values)|7.3341||||0.0219|TWO_SIDED|95.0|1.0734|13.5948||We used hierarchical linear mixed models with maximum likelihood estimation of all available longitudinal data to handle missing data, then used a planned, pairwise comparison to test for end-of-treatment group differences.|Mixed Models Analysis||Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment).|This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.||13.5948|1.0734|0.0219
73888459|NCT02900378|147309627|OTHER|||||||0.0061|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0061
73888460|NCT02900378|147309627|OTHER|||||||0.0143|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0143
73888461|NCT02900378|147309627|OTHER|||||||0.0708|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0708
73886485|NCT04672239|147307069|SUPERIORITY||Mean Difference (Final Values)|8.7775||||0.0072|TWO_SIDED|95.0|2.407|15.148||We used hierarchical linear mixed models with maximum likelihood estimation of all available longitudinal data to handle missing data, then used a planned, pairwise comparison to test for end-of-treatment group differences.|Mixed Models Analysis||Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment).|This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.||15.1480|2.4070|0.0072
73886486|NCT04672239|147307070|SUPERIORITY||Odds Ratio (OR)|1.5072||||0.2259|TWO_SIDED|95.0|0.7759|2.9281|||Generalized Linear Model|We used a Generalized Linear Model with binomial distribution (abstinent vs. smoking) and logit link with repeated measures over time.|The odds ratio compares the SiS app treatment to the QG app treatment at week 6 post-quit (end-of-treatment).|This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the QuitGuide app treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., end-of-treatment).||2.9281|0.7759|0.2259
73886487|NCT04672239|147307070|SUPERIORITY||Odds Ratio (OR)|1.963||||0.0579|TWO_SIDED|95.0|0.9776|3.9415|||Generalized Linear Model|We used a Generalized Linear Model with binomial distribution (abstinent vs. smoking) and logit link with repeated measures over time.|The odds ratio compares the SiS app treatment to the CtA pamphlet at week 6 post-quit (end-of-treatment).|This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the Clearing the Air pamphlet treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., post-treatment).||3.9415|0.9776|0.0579
73886488|NCT04672239|147307071|SUPERIORITY||Wilcoxon Z|0.401||||0.9152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|SiS app treatment vs. QuitGuide app treatment at week 6 post-quit (end-of-treatment)|||||0.9152
73886489|NCT04672239|147307071|SUPERIORITY||Wilcoxon Z|1.372||||0.3557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|Pairwise comparison, SiS app treatment vs. CTA pamphlet at week 6 post-quit (end-of-treatment)|||||0.3557
73888462|NCT02900378|147309627|OTHER|||||||0.075|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0750
74079471|NCT01592240|147712505|SUPERIORITY_OR_OTHER||Adjusted mean difference|-41.13|||<|0.001|TWO_SIDED|95.0|-52.32|-29.94|||Mixed models repeated measures analysis|||Week 12||-29.94|-52.32|<0.001
74079472|NCT01592240|147712505|SUPERIORITY_OR_OTHER||Adjusted mean difference|-29.09|||<|0.001|TWO_SIDED|95.0|-38.42|-19.77|||Mixed models repeated measures analysis|||Week 24||-19.77|-38.42|<0.001
74079473|NCT01592240|147712505|SUPERIORITY_OR_OTHER||Adjusted mean difference|-40.14|||<|0.001|TWO_SIDED|95.0|-49.43|-30.86|||Mixed models repeated measures analysis|||Week 24||-30.86|-49.43|<0.001
74079474|NCT01592240|147712505|SUPERIORITY_OR_OTHER||Adjusted mean difference|-39.16|||<|0.001|TWO_SIDED|95.0|-48.37|-29.94|||Mixed models repeated measures analysis|||Week 24||-29.94|-48.37|<0.001
73886490|NCT04672239|147307072|SUPERIORITY||Mean Difference (Final Values)|0.2936||||0.7469|TWO_SIDED|95.0|-1.4983|2.0856||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided||Comparison of SiS app treatment to the QuitGuide treatment as control (Contrast coding SiS 1, QG -1)|||2.0856|-1.4983|0.7469
73888463|NCT02900378|147309627|OTHER|||||||0.8017|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.8017
73886491|NCT04672239|147307072|SUPERIORITY||Mean Difference (Final Values)|1.2569||||0.1747|TWO_SIDED|95.0|-0.5628|3.0766||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided||Comparison of SiS app treatment to the Clearing the Air pamphlet treatment as control (Contrast coding SiS 1, CtA -1)|||3.0766|-0.5628|0.1747
73886492|NCT04672239|147307073|SUPERIORITY||Wilcoxon Z|1.9255||||0.1315|TWO_SIDED|||||p-values were not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method||||||0.1315
73886493|NCT04672239|147307073|SUPERIORITY||Wilcoxon Z|1.401||||0.3403|TWO_SIDED|||||the p-value was not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|SiS app vs. Clearing the Air pamphlet|||||0.3403
73886494|NCT04672239|147307074|SUPERIORITY||Mean Difference (Final Values)|0.2289||||0.0429|TWO_SIDED|95.0|0.007364|0.4505||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QuitGuide app|0.4505|0.007364|0.0429
73886495|NCT04672239|147307074|SUPERIORITY||Mean Difference (Final Values)|0.1609||||0.16|TWO_SIDED|95.0|-0.06415|0.386||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet|0.3860|-0.06415|0.1600
73886496|NCT04672239|147307075|SUPERIORITY||Mean Difference (Final Values)|0.152||||0.1996|TWO_SIDED|95.0|-0.08092|0.3848||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QG app|0.3848|-0.08092|0.1996
73886497|NCT04672239|147307075|SUPERIORITY||Mean Difference (Final Values)|0.292||||0.0154|TWO_SIDED|95.0|0.05636|0.5276||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet (control)|0.5276|0.05636|0.0154
73886498|NCT04672239|147307076|SUPERIORITY||Mean Difference (Final Values)|2.6255||||0.2988|TWO_SIDED|95.0|-2.3458|7.5968||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QuitGuide app (control)|7.5968|-2.3458|0.2988
73886499|NCT04672239|147307076|SUPERIORITY||Mean Difference (Final Values)|3.9277||||0.1251|TWO_SIDED|95.0|-1.1015|8.9569||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet (control)|8.9569|-1.1015|0.1251
73886500|NCT04672239|147307077|SUPERIORITY||Wilcoxon Z|-0.8096||||0.4182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.4182
73886501|NCT04672239|147307078|SUPERIORITY||Wilcoxon Z|1.909||||0.0563|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0563
73886502|NCT04672239|147307079|SUPERIORITY||Mean Difference (Final Values)|0.1106||||0.5018|TWO_SIDED|95.0|-0.2143|0.4354|||t-test, 2 sided|||||0.4354|-0.2143|0.5018
73886503|NCT04672239|147307080|SUPERIORITY||Mean Difference (Final Values)|0.1406||||0.4246|TWO_SIDED|95.0|-0.2068|0.488|||t-test, 2 sided|||||0.4880|-0.2068|0.4246
73886504|NCT04672239|147307081|SUPERIORITY||Mean Difference (Final Values)|2.4296||||0.4078|TWO_SIDED|95.0|-3.3597|8.2188|||t-test, 2 sided||SiS app vs. QG (control)|||8.2188|-3.3597|0.4078
73886505|NCT03373240|147307106|OTHER|Examining stop signal reaction time changed across the 4-week training period|Mean Difference (Net)|-8.62|STANDARD_ERROR_OF_MEAN|2.79||0.003|TWO_SIDED|95.0|-14.17|-3.06|||Mixed Models Analysis|||||-3.06|-14.17|.003
73886506|NCT03373240|147307107|SUPERIORITY||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.127||0.049|TWO_SIDED|95.0|-0.333|0.184|||ANOVA|||||.184|-.333|.049
73886507|NCT03373240|147307108|SUPERIORITY||Mean Difference (Net)|-1.914|STANDARD_ERROR_OF_MEAN|1.011||0.236|TWO_SIDED|95.0|-3.965|0.136|||ANOVA|||||.136|-3.965|.236
73886508|NCT03373240|147307109|OTHER|Examining whether percentage of risky choices decreased across the 4-wwek training period.|Mean Difference (Net)|-1.62|STANDARD_ERROR_OF_MEAN|0.77||0.039|TWO_SIDED|95.0|-3.15|-0.08|||Mixed Models Analysis|||||-.08|-3.15|.039
73886509|NCT03373240|147307110|OTHER||Mean Difference (Net)|-1.77|STANDARD_ERROR_OF_MEAN|0.82||0.035|TWO_SIDED|95.0|-3.4|-0.13|||Mixed Models Analysis|||||-.13|-3.40|.035
73888464|NCT02900378|147309627|OTHER|||||||0.7956|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.7956
73886510|NCT03373240|147307111|OTHER||Mean Difference (Net)|4.26|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|3.12|5.39|||Mixed Models Analysis|||||5.39|3.12|<.001
73888465|NCT02900378|147309627|OTHER|||||||0.3499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.3499
73886511|NCT03373240|147307112|SUPERIORITY||Mean Difference (Net)|0.933|STANDARD_ERROR_OF_MEAN|0.403||0.008|TWO_SIDED|95.0|0.111|1.755|||ANOVA|||||1.755|.111|.008
73886512|NCT03373240|147307113|SUPERIORITY||Mean Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.096||0.077|TWO_SIDED|97.0|-0.177|0.214|||ANOVA|||||.214|-.177|.077
73886513|NCT03373240|147307114|SUPERIORITY||Mean Difference (Net)|-0.964|STANDARD_ERROR_OF_MEAN|1.902||0.547|TWO_SIDED|95.0|-4.822|2.895|||ANOVA|||||2.895|-4.822|.547
73886514|NCT03373240|147307115|SUPERIORITY||Mean Difference (Net)|-0.532|STANDARD_ERROR_OF_MEAN|0.628||0.436|TWO_SIDED|95.0|-1.805|0.742|||ANOVA|||||.742|-1.805|.436
73886515|NCT04825678|147307154|OTHER||Least squares mean (LSM)|40.72|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|36.05|45.39||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline monthly migraine days (MMD), and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||45.39|36.05|< 0.001
73886516|NCT04825678|147307154|OTHER||LSM|30.84|STANDARD_ERROR_OF_MEAN|14.53||0.058|TWO_SIDED|95.0|-1.3|62.98||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||62.98|-1.30|0.058
73886517|NCT04825678|147307155|OTHER||LSM|37.87|STANDARD_ERROR_OF_MEAN|4.62|<|0.001|TWO_SIDED|95.0|28.62|47.12||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||47.12|28.62|< 0.001
73886518|NCT04825678|147307155|OTHER||LSM|43.25|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|38.06|48.44||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||48.44|38.06|< 0.001
73886519|NCT04825678|147307164|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.9|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-49.39|-40.41||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Physical Function Domain||-40.41|-49.39|< 0.001
73886520|NCT04825678|147307164|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-54.15|STANDARD_ERROR_OF_MEAN|8.43|<|0.001|TWO_SIDED|95.0|-73.43|-34.86||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Physical Function Domain||-34.86|-73.43|< 0.001
73886521|NCT04825678|147307164|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed baseline MMD, and selected baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.35|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-48.26|-40.44||P-value is nominal to compare the mean change from baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Usual Activities Domain||-40.44|-48.26|< 0.001
73886522|NCT04825678|147307164|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-43.8|STANDARD_ERROR_OF_MEAN|4.47|<|0.001|TWO_SIDED|95.0|-53.51|-34.08||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Usual Activities Domain||-34.08|-53.51|< 0.001
73886523|NCT04825678|147307164|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.39|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-48.65|-40.14||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Social Function Domain||-40.14|-48.65|< 0.001
73886524|NCT04825678|147307164|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-45.03|STANDARD_ERROR_OF_MEAN|6.97|<|0.001|TWO_SIDED|95.0|-60.28|-29.79||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Social Function Domain||-29.79|-60.28|< 0.001
73888466|NCT02900378|147309627|OTHER|||||||0.1192|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.1192
73886525|NCT04825678|147307164|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-45.5|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-50.29|-40.7||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Emotional Function Domain||-40.70|-50.29|< 0.001
73886526|NCT04825678|147307164|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-60.06|STANDARD_ERROR_OF_MEAN|10.98|<|0.001|TWO_SIDED|95.0|-85.16|-34.96||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Emotional Function Domain||-34.96|-85.16|< 0.001
73886527|NCT04825678|147307165|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-34.38|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-41.72|-27.03||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Physical Function Domain||-27.03|-41.72|< 0.001
73886528|NCT04825678|147307165|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-49.56|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|95.0|-54.44|-44.69||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Physical Function Domain||-44.69|-54.44|< 0.001
73886529|NCT04825678|147307165|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed baseline MMD, and selected baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-35.76|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-41.47|-30.06||P-value is nominal to compare the mean change from baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Usual Activities Domain||-30.06|-41.47|< 0.001
73886530|NCT04825678|147307165|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-46.7|STANDARD_ERROR_OF_MEAN|2.23|<|0.001|TWO_SIDED|95.0|-51.1|-42.29||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Usual Activities Domain||-42.29|-51.10|< 0.001
73886531|NCT04825678|147307165|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-36.42|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-42.89|-29.96||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Social Function Domain||-29.96|-42.89|< 0.001
73886532|NCT04825678|147307165|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-46.73|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-51.49|-41.98||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Social Function Domain||-41.98|-51.49|< 0.001
73886533|NCT04825678|147307165|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-41.44|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-49.47|-33.4||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Emotional Function Domain||-33.40|-49.47|< 0.001
73886534|NCT04825678|147307165|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-47.67|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-52.95|-42.39||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Emotional Function Domain||-42.39|-52.95|< 0.001
73886535|NCT05565742|147307218|SUPERIORITY||LS Mean difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|8.82|<|0.001|TWO_SIDED|95.0|-55.8|-20.6|||Mixed Models Analysis|||||-20.6|-55.8|<0.001
73886536|NCT05565742|147307218|SUPERIORITY||LS Mean difference (Final Values)|-75.2|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-80.4|-68.5|||Mixed Models Analysis|||||-68.5|-80.4|<0.001
73886537|NCT05565742|147307218|SUPERIORITY||LS Mean difference (Final Values)|-93.9|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-95.1|-92.5|||Mixed Models Analysis|||||-92.5|-95.1|<0.001
73886538|NCT05565742|147307219|SUPERIORITY||LS Mean difference (Final Values)|-38.9|STANDARD_ERROR_OF_MEAN|9.43||0.002|TWO_SIDED|95.0|-54.9|-17.2|||Mixed Models Analysis|||||-17.2|-54.9|0.002
73888467|NCT02900378|147309627|OTHER|||||||0.5237|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5237
73886539|NCT05565742|147307219|SUPERIORITY||LS Mean difference (Final Values)|-77.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-82.4|-71.1|||Mixed Models Analysis|||||-71.1|-82.4|<0.001
73886540|NCT05565742|147307219|SUPERIORITY||LS Mean difference (Final Values)|-95.0|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-96.1|-93.6|||Mixed Models Analysis|||||-93.6|-96.1|<0.001
73886541|NCT05565742|147307219|SUPERIORITY||LS Mean difference (Final Values)|-76.8|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-81.9|-70.2|||Mixed Models Analysis|||||-70.2|-81.9|<0.001
73886542|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|112.03||||0.001|TWO_SIDED|95.0|6.35|1975.13|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||1975.13|6.35|0.001
73888468|NCT02900378|147309627|OTHER|||||||0.3902|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.3902
73886543|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|2762.52|||<|0.001|TWO_SIDED|95.0|142.74|53463.34|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||53463.34|142.74|<0.001
73888469|NCT02900378|147309627|OTHER|||||||0.4228|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.4228
73888470|NCT02900378|147309627|OTHER|||||||0.1571|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1571
73888471|NCT02900378|147309628|OTHER|||||||0.3231|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.3231
73886544|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|50904.09|||<|0.001|TWO_SIDED|95.0|1700.95|1523398.1|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||1523398.10|1700.95|<0.001
73886545|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|27.94||||0.026|TWO_SIDED|95.0|1.48|527.74|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||527.74|1.48|0.026
73886546|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|309.36|||<|0.001|TWO_SIDED|95.0|17.99|5320.81|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||5320.81|17.99|<0.001
73886547|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|3060.16|||<|0.001|TWO_SIDED|95.0|166.84|56127.55|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||56127.55|166.84|<0.001
73886548|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|32.91||||0.021|TWO_SIDED|95.0|1.7|635.94|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||635.94|1.70|0.021
73886549|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|579.62|||<|0.001|TWO_SIDED|95.0|31.48|10673.41|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||10673.41|31.48|<0.001
73888472|NCT02900378|147309628|OTHER|||||||0.3519|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.3519
74079475|NCT01592240|147712505|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.79|||<|0.001|TWO_SIDED|95.0|-32.88|-14.7|||Mixed models repeated measures analysis|||Week 24||-14.70|-32.88|<0.001
74079476|NCT01592240|147712505|SUPERIORITY_OR_OTHER||Adjusted mean difference|-29.08|||<|0.001|TWO_SIDED|95.0|-38.13|-20.04|||Mixed models repeated measures analysis|||Week 24||-20.04|-38.13|<0.001
74079477|NCT01592240|147712506|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.64||||0.281|TWO_SIDED|95.0|-1.35|4.63|||Mixed models repeated measures analysis|||Week 12||4.63|-1.35|0.281
74079478|NCT01592240|147712506|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.73||||0.251|TWO_SIDED|95.0|-1.24|4.71|||Mixed models repeated measures analysis|||Week 12||4.71|-1.24|0.251
74079479|NCT01592240|147712506|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.53||||0.724|TWO_SIDED|95.0|-2.43|3.5|||Mixed models repeated measures analysis|||Week 12||3.50|-2.43|0.724
74079480|NCT01592240|147712506|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.45||||0.007|TWO_SIDED|95.0|1.21|7.7|||Mixed models repeated measures analysis|||Week 12||7.70|1.21|0.007
74079481|NCT01592240|147712506|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.86||||0.019|TWO_SIDED|95.0|0.63|7.09|||Mixed models repeated measures analysis|||Week 12||7.09|0.63|0.019
74079482|NCT01592240|147712506|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.72||||0.225|TWO_SIDED|95.0|-1.07|4.51|||Mixed models repeated measures analysis|||Week 24||4.51|-1.07|0.225
74079483|NCT01592240|147712506|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.79||||0.571|TWO_SIDED|95.0|-1.97|3.56|||Mixed models repeated measures analysis|||Week 24||3.56|-1.97|0.571
74079484|NCT01592240|147712506|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.49||||0.725|TWO_SIDED|95.0|-2.25|3.24|||Mixed models repeated measures analysis|||Week 24||3.24|-2.25|0.725
74079485|NCT01592240|147712506|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.01||||0.268|TWO_SIDED|95.0|-1.56|5.57|||Mixed models repeated measures analysis|||Week 24||5.57|-1.56|0.268
74079486|NCT01592240|147712506|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01||||0.996|TWO_SIDED|95.0|-3.55|3.54|||Mixed models repeated measures analysis|||Week 24||3.54|-3.55|0.996
74079487|NCT01592240|147712507|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.41||||0.246|TWO_SIDED|95.0|-2.38|9.21|||Mixed models repeated measures analysis|||Week 12||9.21|-2.38|0.246
74079488|NCT01592240|147712507|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.62||||0.371|TWO_SIDED|95.0|-3.14|8.38|||Mixed models repeated measures analysis|||Week 12||8.38|-3.14|0.371
74079489|NCT01592240|147712507|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.35||||0.643|TWO_SIDED|95.0|-4.4|7.1|||Mixed models repeated measures analysis|||Week 12||7.10|-4.40|0.643
74079490|NCT01592240|147712507|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.66||||0.018|TWO_SIDED|95.0|1.33|13.99|||Mixed models repeated measures analysis|||Week 12||13.99|1.33|0.018
74079491|NCT01592240|147712507|SUPERIORITY_OR_OTHER||Adjusted mean difference|6.52||||0.043|TWO_SIDED|95.0|0.22|12.83|||Mixed models repeated measures analysis|||Week 12||12.83|0.22|0.043
74079492|NCT01592240|147712507|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.9||||0.16|TWO_SIDED|95.0|-1.56|9.36|||Mixed models repeated measures analysis|||Week 24||9.36|-1.56|0.160
74079493|NCT01592240|147712507|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.85||||0.758|TWO_SIDED|95.0|-4.56|6.25|||Mixed models repeated measures analysis|||Week 24||6.25|-4.56|0.758
74079494|NCT01592240|147712507|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.57||||0.347|TWO_SIDED|95.0|-2.81|7.95|||Mixed models repeated measures analysis|||Week 24||7.95|-2.81|0.347
74079495|NCT01592240|147712507|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.99||||0.343|TWO_SIDED|95.0|-3.22|9.21|||Mixed models repeated measures analysis|||Week 24||9.21|-3.22|0.343
74079496|NCT01592240|147712507|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7||||0.824|TWO_SIDED|95.0|-6.87|5.48|||Mixed models repeated measures analysis|||Week 24||5.48|-6.87|0.824
74079497|NCT01592240|147712508|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.55|||<|0.001|TWO_SIDED|95.0|-25.44|-11.67|||Mixed models repeated measures analysis|||Week 12||-11.67|-25.44|<0.001
74079498|NCT01592240|147712508|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.67|||<|0.001|TWO_SIDED|95.0|-34.55|-20.79|||Mixed models repeated measures analysis|||Week 12||-20.79|-34.55|<0.001
74079499|NCT01592240|147712508|SUPERIORITY_OR_OTHER||Adjusted mean difference|-32.09|||<|0.001|TWO_SIDED|95.0|-38.95|-25.22|||Mixed models repeated measures analysis|||Week 12||-25.22|-38.95|<0.001
74079500|NCT01592240|147712508|SUPERIORITY_OR_OTHER||Adjusted mean difference|-14.56|||<|0.001|TWO_SIDED|95.0|-22.89|-6.24|||Mixed models repeated measures analysis|||Week 12||-6.24|-22.89|<0.001
74079501|NCT01592240|147712508|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.5|||<|0.001|TWO_SIDED|95.0|-36.83|-20.16|||Mixed models repeated measures analysis|||Week 12||-20.16|-36.83|<0.001
74079502|NCT01592240|147712508|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.67|||<|0.001|TWO_SIDED|95.0|-27.07|-12.27|||Mixed models repeated measures analysis|||Week 24||-12.27|-27.07|<0.001
74079503|NCT01592240|147712508|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.17|||<|0.001|TWO_SIDED|95.0|-35.52|-20.82|||Mixed models repeated measures analysis|||Week 24||-20.82|-35.52|<0.001
74079504|NCT01592240|147712508|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.41|||<|0.001|TWO_SIDED|95.0|-32.73|-18.09|||Mixed models repeated measures analysis|||Week 24||-18.09|-32.73|<0.001
74079505|NCT01592240|147712508|SUPERIORITY_OR_OTHER||Adjusted mean difference|-12.72|||<|0.001|TWO_SIDED|95.0|-19.35|-6.09|||Mixed models repeated measures analysis|||Week 24||-6.09|-19.35|<0.001
74079506|NCT01592240|147712508|SUPERIORITY_OR_OTHER||Adjusted mean difference|-16.85|||<|0.001|TWO_SIDED|95.0|-23.47|-10.23|||Mixed models repeated measures analysis|||Week 24||-10.23|-23.47|<0.001
74079507|NCT01592240|147712509|SUPERIORITY_OR_OTHER||Adjusted mean difference|-21.58|||<|0.001|TWO_SIDED|95.0|-29.23|-13.92|||Mixed models repeated measures analysis|||Week 12||-13.92|-29.23|<0.001
74079508|NCT01592240|147712509|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.54|||<|0.001|TWO_SIDED|95.0|-38.19|-22.89|||Mixed models repeated measures analysis|||Week 12||-22.89|-38.19|<0.001
74079509|NCT01592240|147712509|SUPERIORITY_OR_OTHER||Adjusted mean difference|-35.95|||<|0.001|TWO_SIDED|95.0|-43.59|-28.31|||Mixed models repeated measures analysis|||Week 12||-28.31|-43.59|<0.001
74079510|NCT01592240|147712509|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.14|||<|0.001|TWO_SIDED|95.0|-25.87|-8.41|||Mixed models repeated measures analysis|||Week 12||-8.41|-25.87|<0.001
73888473|NCT02900378|147309628|OTHER|||||||0.8335|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.8335
73886550|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|14659.81|||<|0.001|TWO_SIDED|95.0|646.35|332498.98|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||332498.98|646.35|<0.001
73886551|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|15.94||||0.071|TWO_SIDED|95.0|0.79|321.21|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||321.21|0.79|0.071
73888474|NCT02900378|147309628|OTHER|||||||0.0465|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0465
73886552|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|86.32||||0.002|TWO_SIDED|95.0|5.07|1468.36|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||1468.36|5.07|0.002
73888475|NCT02900378|147309628|OTHER|||||||0.5016|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.5016
73886553|NCT05565742|147307220|SUPERIORITY||Odds Ratio (OR)|956.84|||<|0.001|TWO_SIDED|95.0|55.75|16422.76|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||16422.76|55.75|<0.001
73886554|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|32.05|||<|0.001|TWO_SIDED|95.0|5.36|191.58|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||191.58|5.36|<0.001
73886555|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|602.39|||<|0.001|TWO_SIDED|95.0|95.36|3805.22|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||3805.22|95.36|<0.001
73886556|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|6953.37|||<|0.001|TWO_SIDED|95.0|527.56|91646.24|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||91646.24|527.56|<0.001
73886557|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|347.76|||<|0.001|TWO_SIDED|95.0|57.46|2104.62|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||2104.62|57.46|<0.001
73886558|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|54.99||||0.007|TWO_SIDED|95.0|2.98|1015.84|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||1015.84|2.98|0.007
73886559|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|363.15|||<|0.001|TWO_SIDED|95.0|20.83|6332.68|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||6332.68|20.83|<0.001
73886560|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|2953.53|||<|0.001|TWO_SIDED|95.0|150.95|57790.71|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||57790.71|150.95|<0.001
73886561|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|375.16|||<|0.001|TWO_SIDED|95.0|21.46|6571.66|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||6571.66|21.46|<0.001
73886562|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|16.43||||0.068|TWO_SIDED|95.0|0.81|331.69|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||331.69|0.81|0.068
73886563|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|84.97||||0.002|TWO_SIDED|95.0|4.99|1447.48|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||1447.48|4.99|0.002
73886564|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|594.66|||<|0.001|TWO_SIDED|95.0|33.99|10405.09|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||10405.09|33.99|<0.001
73886565|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|110.17||||0.001|TWO_SIDED|95.0|6.47|1875.77|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||1875.77|6.47|0.001
73886566|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|11.61||||0.01|TWO_SIDED|95.0|1.81|74.29|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||74.29|1.81|0.010
73886567|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|233.25|||<|0.001|TWO_SIDED|95.0|39.92|1362.79|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||1362.79|39.92|<0.001
73886568|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|3087.58|||<|0.001|TWO_SIDED|95.0|331.26|28778.1|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||28778.10|331.26|<0.001
73886569|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|144.58|||<|0.001|TWO_SIDED|95.0|25.2|829.42|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||829.42|25.20|<0.001
73886570|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|11.16||||0.125|TWO_SIDED|95.0|0.51|243.85|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||243.85|0.51|0.125
73886571|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|148.3|||<|0.001|TWO_SIDED|95.0|8.64|2546.89|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||2546.89|8.64|<0.001
73886572|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|1431.38|||<|0.001|TWO_SIDED|95.0|77.76|26349.86|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||26349.86|77.76|<0.001
73886573|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|147.78|||<|0.001|TWO_SIDED|95.0|8.6|2538.95|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||2538.95|8.60|<0.001
73886574|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|1.99||||0.733|TWO_SIDED|95.0|0.04|104.02|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||104.02|0.04|0.733
73886575|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|34.28||||0.015|TWO_SIDED|95.0|1.98|594.46|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||594.46|1.98|0.015
73886576|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|159.77|||<|0.001|TWO_SIDED|95.0|9.4|2716.42|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||2716.42|9.40|<0.001
73886577|NCT05565742|147307221|SUPERIORITY||Odds Ratio (OR)|37.98||||0.013|TWO_SIDED|95.0|2.19|659.75|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||659.75|2.19|0.013
73886578|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-47.4|STANDARD_ERROR_OF_MEAN|7.29|<|0.001|TWO_SIDED|95.0|-59.9|-30.9|||Mixed Models Analysis|||Baseline to Day 60||-30.9|-59.9|<0.001
73886579|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-80.9|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-84.7|-76.1|||Mixed Models Analysis|||Baseline to Day 60||-76.1|-84.7|<0.001
73886580|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-95.5|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-96.3|-94.5|||Mixed Models Analysis|||Baseline to Day 60||-94.5|-96.3|<0.001
73886581|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-95.5|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-96.3|-94.5|||Mixed Models Analysis|||Baseline to Day 60||-94.5|-96.3|<0.001
73886582|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-31.9|STANDARD_ERROR_OF_MEAN|11.1||0.019|TWO_SIDED|95.0|-50.6|-6.2|||Mixed Models Analysis|||Baseline to Day 180||-6.2|-50.6|0.019
73886583|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-66.0|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|95.0|-73.8|-55.9|||Mixed Models Analysis|||Baseline to Day 180||-55.9|-73.8|<0.001
73886584|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-90.7|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|-92.6|-88.3|||Mixed Models Analysis|||Baseline to Day 180||-88.3|-92.6|<0.001
73886585|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-90.7|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|-92.6|-88.3|||Mixed Models Analysis|||Baseline to Day 180||-88.3|-92.6|<0.001
73886586|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-47.3|STANDARD_ERROR_OF_MEAN|8.25|<|0.001|TWO_SIDED|95.0|-61.3|-28.3|||Mixed Models Analysis|||Baseline to Day 240||-28.3|-61.3|<0.001
73886587|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-84.7|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-88.1|-80.3|||Mixed Models Analysis|||Baseline to Day 240||-80.3|-88.1|<0.001
73886588|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-96.8|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-97.4|-95.9|||Mixed Models Analysis|||Baseline to Day 240||-95.9|-97.4|<0.001
73886589|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-84.7|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-87.9|-80.8|||Mixed Models Analysis|||Baseline to Day 240||-80.8|-87.9|<0.001
73886590|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|11.45||0.029|TWO_SIDED|95.0|-49.4|-3.6|||Mixed Models Analysis|||Baseline to Day 360||-3.6|-49.4|0.029
73886591|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-67.4|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-74.9|-57.6|||Mixed Models Analysis|||Baseline to Day 360||-57.6|-74.9|<0.001
73886592|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-91.0|STANDARD_ERROR_OF_MEAN|1.11|<|0.001|TWO_SIDED|95.0|-92.9|-88.5|||Mixed Models Analysis|||Baseline to Day 360||-88.5|-92.9|<0.001
73886593|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-67.8|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-74.8|-59.0|||Mixed Models Analysis|||Baseline to Day 360||-59.0|-74.8|<0.001
73886594|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-19.7|STANDARD_ERROR_OF_MEAN|10.45||0.093|TWO_SIDED|95.0|-37.8|3.7|||Mixed Models Analysis|||Baseline to Day 540||3.7|-37.8|0.093
73886595|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-45.8|STANDARD_ERROR_OF_MEAN|5.76|<|0.001|TWO_SIDED|95.0|-56.0|-33.2|||Mixed Models Analysis|||Baseline to Day 540||-33.2|-56.0|<0.001
73886596|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-74.2|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-78.8|-68.5|||Mixed Models Analysis|||Baseline to Day 540||-68.5|-78.8|<0.001
73886597|NCT05565742|147307222|SUPERIORITY||LS Mean difference (Final Values)|-53.4|STANDARD_ERROR_OF_MEAN|4.67|<|0.001|TWO_SIDED|95.0|-61.7|-43.3|||Mixed Models Analysis|||Baseline to Day 540||-43.3|-61.7|<0.001
73886598|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.74||0.01|TWO_SIDED|95.0|-17.5|-2.6|||Mixed Models Analysis|||Baseline to Day 60||-2.6|-17.5|0.010
73886599|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-11.9|STANDARD_ERROR_OF_MEAN|3.02|<|0.001|TWO_SIDED|95.0|-17.7|-5.8|||Mixed Models Analysis|||Baseline to Day 60||-5.8|-17.7|<0.001
73886600|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-19.0|-8.8|||Mixed Models Analysis|||Baseline to Day 60||-8.8|-19.0|<0.001
73886601|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-19.0|-8.8|||Mixed Models Analysis|||Baseline to Day 60||-8.8|-19.0|<0.001
73886602|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|4.27||0.068|TWO_SIDED|95.0|-16.2|0.6|||Mixed Models Analysis|||Baseline to Day 180||0.6|-16.2|0.068
73886603|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|3.4||0.003|TWO_SIDED|95.0|-17.1|-3.8|||Mixed Models Analysis|||Baseline to Day 180||-3.8|-17.1|0.003
73886604|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-19.3|-7.9|||Mixed Models Analysis|||Baseline to Day 180||-7.9|-19.3|<0.001
73886605|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-19.3|-7.9|||Mixed Models Analysis|||Baseline to Day 180||-7.9|-19.3|<0.001
73886606|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|3.93||0.026|TWO_SIDED|95.0|-16.7|-1.2|||Mixed Models Analysis|||Baseline to Day 240||-1.2|-16.7|0.026
73886607|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-15.4|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-21.1|-9.3|||Mixed Models Analysis|||Baseline to Day 240||-9.3|-21.1|<0.001
73886608|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-15.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-21.0|-9.6|||Mixed Models Analysis|||Baseline to Day 240||-9.6|-21.0|<0.001
73886609|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-16.3|-4.4|||Mixed Models Analysis|||Baseline to Day 240||-4.4|-16.3|<0.001
73886610|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|4.21||0.111|TWO_SIDED|95.0|-14.9|1.7|||Mixed Models Analysis|||Baseline to Day 360||1.7|-14.9|0.111
73886611|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-12.0|STANDARD_ERROR_OF_MEAN|3.25|<|0.001|TWO_SIDED|95.0|-18.1|-5.3|||Mixed Models Analysis|||Baseline to Day 360||-5.3|-18.1|<0.001
73886612|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-20.0|-7.8|||Mixed Models Analysis|||Baseline to Day 360||-7.8|-20.0|<0.001
73886613|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|3.3||0.013|TWO_SIDED|95.0|-14.9|-1.9|||Mixed Models Analysis|||400 mg LY3819469, Placebo||-1.9|-14.9|0.013
73886614|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|4.2||0.51|TWO_SIDED|95.0|-10.7|5.8|||Mixed Models Analysis|||Baseline to Day 540||5.8|-10.7|0.510
73886615|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|3.35||0.173|TWO_SIDED|95.0|-11.1|2.1|||Mixed Models Analysis|||Baseline to Day 540||2.1|-11.1|0.173
73886616|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-18.6|-6.8|||Mixed Models Analysis|||Baseline to Day 540||-6.8|-18.6|<0.001
73886617|NCT05565742|147307223|SUPERIORITY||LS Mean difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|3.27||0.139|TWO_SIDED|95.0|-11.2|1.7|||Mixed Models Analysis|||Baseline to Day 540||1.7|-11.2|0.139
73886618|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|16.71||0.353|TWO_SIDED|95.0|-44.3|23.3|||Mixed Models Analysis|||Baseline to Day 60||23.3|-44.3|0.353
73886619|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|15.84||0.902|TWO_SIDED|95.0|-28.7|34.7|||Mixed Models Analysis|||Baseline to Day 60||34.7|-28.7|0.902
73886620|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|13.65||0.779|TWO_SIDED|95.0|-27.4|27.1|||Mixed Models Analysis|||Baseline to Day 60||27.1|-27.4|0.779
73886621|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|13.65||0.779|TWO_SIDED|95.0|-27.4|27.1|||Mixed Models Analysis|||Baseline to Day 60||27.1|-27.4|0.779
73886622|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|20.41||0.987|TWO_SIDED|95.0|-32.8|49.7|||Mixed Models Analysis|||Baseline to Day 180||49.7|-32.8|0.987
73886623|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-15.2|STANDARD_ERROR_OF_MEAN|13.96||0.316|TWO_SIDED|95.0|-38.7|17.2|||Mixed Models Analysis|||Baseline to Day 180||17.2|-38.7|0.316
73886624|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|15.37||0.72|TWO_SIDED|95.0|-20.9|40.4|||Mixed Models Analysis|||Baseline to Day 180||40.4|-20.9|0.720
73886625|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|15.37||0.72|TWO_SIDED|95.0|-20.9|40.4|||Mixed Models Analysis|||Baseline to Day 180||40.4|-20.9|0.720
73886626|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|14.66||0.461|TWO_SIDED|95.0|-36.1|22.6|||Mixed Models Analysis|||Baseline to Day 240||22.6|-36.1|0.461
73886627|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|11.29||0.194|TWO_SIDED|95.0|-35.6|9.4|||Mixed Models Analysis|||Baseline to Day 240||9.4|-35.6|0.194
73886628|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|12.87||0.898|TWO_SIDED|95.0|-24.0|27.2|||Mixed Models Analysis|||Baseline to Day 240||27.2|-24.0|0.898
73886629|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|11.81||0.448|TWO_SIDED|95.0|-29.9|17.0|||Mixed Models Analysis|||Baseline to Day 240||17.0|-29.9|0.448
73886630|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|29.6|STANDARD_ERROR_OF_MEAN|28.05||0.233|TWO_SIDED|95.0|-15.4|98.4|||Mixed Models Analysis|||Baseline to Day 360||98.4|-15.4|0.233
73886631|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|18.04||0.891|TWO_SIDED|95.0|-27.6|44.9|||Mixed Models Analysis|||Baseline to Day 360||44.9|-27.6|0.891
73886632|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|17.18||0.984|TWO_SIDED|95.0|-29.0|39.9|||Mixed Models Analysis|||Baseline to Day 360||39.9|-29.0|0.984
73886633|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|19.4|STANDARD_ERROR_OF_MEAN|20.52||0.302|TWO_SIDED|95.0|-14.8|67.5|||Mixed Models Analysis|||Baseline to Day 360||67.5|-14.8|0.302
73886634|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|18.49||0.684|TWO_SIDED|95.0|-37.9|36.8|||Mixed Models Analysis|||Baseline to Day 540||36.8|-37.9|0.684
73886635|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|16.19||0.933|TWO_SIDED|95.0|-28.6|36.3|||Mixed Models Analysis|||Baseline to Day 540||36.3|-28.6|0.933
73886636|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|16.33||0.962|TWO_SIDED|95.0|-26.7|38.6|||Mixed Models Analysis|||Baseline to Day 540||38.6|-26.7|0.962
73886637|NCT05565742|147307224|SUPERIORITY||LS Mean difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|18.52||0.422|TWO_SIDED|95.0|-17.2|56.9|||Mixed Models Analysis|||Baseline to Day 540||56.9|-17.2|0.422
73886638|NCT02855125|147307237|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2744|TWO_SIDED|95.0|0.71|1.88|||Log Rank|1-sided stratified log-rank test.|Based on stratified Cox regression model .|||1.88|0.71|0.2744
73886639|NCT02855125|147307238|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.1431|TWO_SIDED|95.0|0.8|2.14|||Log Rank|1-sided stratified log-rank test.|Based on stratified Cox regression model.|||2.14|0.80|0.1431
73886640|NCT04467905|147307243|SUPERIORITY||Mean Difference (Final Values)|-29.9|||<|0.0001|TWO_SIDED|95.0|-40.3|-19.3|||ANCOVA||The mean difference is the difference in adjusted means for the change between baseline value and nadir in the placebo group and the change between baseline and nadir in the etripamil group.|||-19.3|-40.3|<0.0001
73886641|NCT00664443|147307248|OTHER||Sensitivity|65.9|||||TWO_SIDED|95.0|63.5|68.2||||||||68.2|63.5|
73886642|NCT00664443|147307249|OTHER||Specificity|32.3|||||TWO_SIDED|95.0|29.0|35.9||||||||35.9|29.0|
73886643|NCT04586205|147307256|OTHER|||||||0.024|||||||ANOVA|||The baseline measurement for this analysis is the Sternberg Sorting Task (SST) at Baseline. This task is designed to assess how individuals store and retrieve random information from short-term memory. This task was administered to all participants before they were randomized into one of two groups (active TMS first then sham TMS or sham TMS first then active TMS).||||0.024
73886644|NCT04586205|147307257|OTHER||Mean Difference (Final Values)|0.02||||0.18|TWO_SIDED||||||t-test, 2 sided||The difference in means between High-Load IAPS (.69) and Low-Load IAPS (.67) in the group that received active then sham TMS.|The baseline measurement for this analysis is the International Affective Picture System (IAPS) at baseline. This is an emotional task using IAPS picture that will also compare low load and high load conditions. The number of images will vary by condition load, but for both the high-load \& low-load conditions, participants will look at IAPS pictures and answer questions about the images. We compare mean High-Load IAPS and Low-Load IAPS scores in the group that received active then sham TMS.||||0.18
73886645|NCT04586205|147307258|OTHER|||||||0.19|||||||Chi-squared|||The outcome measure for this analysis was the International Affective Picture System (IAPS).||||0.19
73886646|NCT04586205|147307259|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
74079511|NCT01592240|147712509|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.72|||<|0.001|TWO_SIDED|95.0|-39.45|-21.98|||Mixed models repeated measures analysis|||Week 12||-21.98|-39.45|<0.001
73888476|NCT02900378|147309628|OTHER|||||||0.5941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.5941
74079512|NCT01592240|147712509|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.09|||<|0.001|TWO_SIDED|95.0|-30.32|-13.86|||Mixed models repeated measures analysis|||Week 24||-13.86|-30.32|<0.001
74079513|NCT01592240|147712509|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.95|||<|0.001|TWO_SIDED|95.0|-39.13|-22.77|||Mixed models repeated measures analysis|||Week 24||-22.77|-39.13|<0.001
74079514|NCT01592240|147712509|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.23|||<|0.001|TWO_SIDED|95.0|-35.38|-19.09|||Mixed models repeated measures analysis|||Week 24||-19.09|-35.38|<0.001
74079515|NCT01592240|147712509|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.34|||<|0.001|TWO_SIDED|95.0|-22.9|-7.78|||Mixed models repeated measures analysis|||Week 24||-7.78|-22.90|<0.001
74079516|NCT01592240|147712509|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.15|||<|0.001|TWO_SIDED|95.0|-26.7|-11.59|||Mixed models repeated measures analysis|||Week 24||-11.59|-26.70|<0.001
74079517|NCT01592240|147712510|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.77||||0.667|TWO_SIDED|95.0|-6.33|9.88|||Mixed models repeated measures analysis|||Week 12||9.88|-6.33|0.667
74079518|NCT01592240|147712510|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.44||||0.187|TWO_SIDED|95.0|-2.66|13.54|||Mixed models repeated measures analysis|||Week 12||13.54|-2.66|0.187
74079519|NCT01592240|147712510|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.82||||0.352|TWO_SIDED|95.0|-4.25|11.9|||Mixed models repeated measures analysis|||Week 12||11.90|-4.25|0.352
74079520|NCT01592240|147712510|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.6||||0.09|TWO_SIDED|95.0|-0.89|12.09|||Mixed models repeated measures analysis|||Week 12||12.09|-0.89|0.090
74079521|NCT01592240|147712510|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.36||||0.184|TWO_SIDED|95.0|-2.1|10.82|||Mixed models repeated measures analysis|||Week 12||10.82|-2.10|0.184
74079522|NCT01592240|147712510|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.59||||0.879|TWO_SIDED|95.0|-7.09|8.28|||Mixed models repeated measures analysis|||Week 24||8.28|-7.09|0.879
73886654|NCT02121535|147307317|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% confidence interval (CI) for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|101.97|||||TWO_SIDED|90.0|98.94|105.08|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||105.08|98.94|
73886655|NCT02121535|147307318|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|103.77|||||TWO_SIDED|90.0|97.03|110.99|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||110.99|97.03|
73886656|NCT02121535|147307319|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.24|||||TWO_SIDED|90.0|96.8|103.8|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||103.80|96.80|
73886657|NCT02121535|147307320|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.42|||||TWO_SIDED|90.0|97.94|100.93|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||100.93|97.94|
73886658|NCT02121535|147307321|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.5|||||TWO_SIDED|90.0|98.08|100.94|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||100.94|98.08|
73886659|NCT02121535|147307322|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.07|||||TWO_SIDED|90.0|98.45|101.72|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||101.72|98.45|
73886660|NCT02121535|147307323|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|110.16|||||TWO_SIDED|90.0|106.87|113.54|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||113.54|106.87|
73886661|NCT02121535|147307324|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.3|||||TWO_SIDED|90.0|102.53|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||106.10|102.53|
73886662|NCT02121535|147307325|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.37|||||TWO_SIDED|90.0|102.68|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||106.10|102.68|
73886663|NCT00091949|147307326|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.0067|TWO_SIDED|95.0|0.62|0.93||P-value adjusted for interim looks.|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for interim looks.|||0.93|0.62|.0067
73886664|NCT00091949|147307327|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.19|TWO_SIDED|95.0|0.61|1.1||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; conference interval (CI) adjusted for multiplicity (5 secondary outcomes).|||1.1|0.61|0.19
74079523|NCT01592240|147712510|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.43||||0.911|TWO_SIDED|95.0|-7.17|8.02|||Mixed models repeated measures analysis|||Week 24||8.02|-7.17|0.911
74079524|NCT01592240|147712510|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.12||||0.283|TWO_SIDED|95.0|-3.44|11.69|||Mixed models repeated measures analysis|||Week 24||11.69|-3.44|0.283
74079525|NCT01592240|147712510|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.41||||0.728|TWO_SIDED|95.0|-9.41|6.59|||Mixed models repeated measures analysis|||Week 24||6.59|-9.41|0.728
73886665|NCT00091949|147307328|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.11|TWO_SIDED|95.0|0.52|1.07||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.07|0.52|0.11
73886666|NCT00091949|147307330|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.52|TWO_SIDED|95.0|0.73|1.17||p-value adjusted for multiplicity (5 secondary outcomes)|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.17|0.73|0.52
73886667|NCT00091949|147307331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.023||||0.88|TWO_SIDED|95.0|-0.326|0.28|||Mixed Models Analysis||Pioglitazone arm compared to placebo.|Changes in modified mini-mental examination (3MS) score from baseline (to annual scores) were analyzed using a longitudinal repeated measures mixed effects model.||0.280|-0.326|0.88
73886668|NCT00091949|147307332|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.11|TWO_SIDED|95.0|0.65|1.05||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.05|0.65|0.11
73886669|NCT04328077|147307371|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|9.44||0.7755|TWO_SIDED|95.0|-16.1|21.5|||ANCOVA|||||21.5|-16.1|0.7755
73886670|NCT04328077|147307371|SUPERIORITY||Mean Difference (Final Values)|-12.66|STANDARD_ERROR_OF_MEAN|9.369||0.1798|TWO_SIDED|95.0|-31.3|5.9|||ANCOVA|||||5.9|-31.3|0.1798
73886671|NCT04328077|147307371|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|9.807||0.4229|TWO_SIDED|95.0|-27.4|11.6|||ANCOVA|||||11.6|-27.4|0.4229
73886672|NCT00313014|147307393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.163|<|0.001|TWO_SIDED|95.0|-0.99|-0.35||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effects.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.35|-0.99|<.001
73888477|NCT02900378|147309628|OTHER|||||||0.2019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.2019
73888478|NCT02900378|147309628|OTHER|||||||0.4125|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.4125
73888479|NCT02900378|147309628|OTHER|||||||0.5702|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5702
73886673|NCT00313014|147307393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.161|<|0.001|TWO_SIDED|95.0|-1.07|-0.44||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effect.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.44|-1.07|<.001
73886674|NCT00313014|147307394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.9|-0.13||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took \> 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.13|-0.90|.006
73886675|NCT00313014|147307394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.158|TWO_SIDED|95.0|-0.7|0.09||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took \> 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||0.09|-0.70|.158
73886676|NCT00313014|147307395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.065|TWO_SIDED|95.0|-3.55|0.11||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||0.11|-3.55|.065
73886677|NCT00313014|147307395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.031||95.0|-3.79|-0.18||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.18|-3.79|.031
73886678|NCT00313014|147307396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.735|<|0.001|TWO_SIDED|95.0|-9.64|-2.82||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed linear model: treatment, time as fixed effects, screening, prerandomization sleep disturbance subscale as covariates; subject as a random effect||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-2.82|-9.64|<.001
73886679|NCT00313014|147307396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.65|STANDARD_ERROR_OF_MEAN|1.709||0.121||95.0|-6.01|0.7||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that BTDS 20 arm was different from the BTDS 5 arm.||0.70|-6.01|.121
73886680|NCT01181349|147307406|SUPERIORITY_OR_OTHER||||||=|0.169|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.||||=0.169
73886681|NCT01181349|147307408|SUPERIORITY_OR_OTHER||||||=|0.01|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.||||=0.01
73886682|NCT00744497|147307411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9009|TWO_SIDED|95.53|0.87|1.13||An interim analysis on survival was performed and the final test was corrected for multiplicity.|Log Rank|||Confidence intervals for median overall survival calculated using Brookmeyer and Crowley method. Compared survival in arms by 2-sided, alpha=0.0447 level, log-rank test, stratified by bisphosphonate intake (yes/no) and urinary N-telopeptide category (\<60 vs ≥60 nmol/mmol creatinine) defined at randomization. Null hypothesis was survival equal in both arms. Power calculations were that ≥858 deaths would lead to ≥90% power at 5% level for rejecting null hypothesis, given true hazard ratio of 0.8.||1.13|0.87|0.9009
73886683|NCT00744497|147307412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.935|||||TWO_SIDED|95.0|0.688|1.271||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.||1.271|0.688|
73886684|NCT00744497|147307413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.64|1.02||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.02|0.64|
73888480|NCT02900378|147309628|OTHER|||||||0.4752|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4752
73886685|NCT00744497|147307414|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.93|1.763||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.||1.763|0.930|
73886686|NCT00744497|147307415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.82|1.05||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.05|0.82|
73886687|NCT00744497|147307416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.79|1.01||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.01|0.79|
73886688|NCT00744497|147307417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.791|||||TWO_SIDED|95.0|0.594|1.052||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for of experimental to control group.||1.052|0.594|
73886689|NCT01116986|147307435|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.954||||0.312|TWO_SIDED|95.0|0.871|1.045|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.045|.871|.312
73886690|NCT01116986|147307435|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.664|TWO_SIDED|95.0|0.894|1.074|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.074|.894|.664
73886691|NCT01116986|147307435|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.989||||0.814|TWO_SIDED|95.0|0.903|1.084|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.084|.903|.814
73886692|NCT01116986|147307435|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.925||||0.093|TWO_SIDED|95.0|0.844|1.013|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.013|.844|.093
73886693|NCT01116986|147307435|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.983||||0.716|TWO_SIDED|95.0|0.898|1.077|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.077|.898|.716
73886694|NCT01116986|147307435|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.031||||0.511|TWO_SIDED|95.0|0.941|1.13|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.130|.941|.511
73886695|NCT01116986|147307436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.087||||0.341|TWO_SIDED|95.0|0.916|1.29|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch) would result in significantly higher abstinence at 16 weeks post-quit.||1.290|.916|.341
73888481|NCT02900378|147309628|OTHER|||||||0.5343|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.5343
73888482|NCT02900378|147309628|OTHER|||||||0.0985|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.0985
73888483|NCT02900378|147309629|OTHER|||||||0.4525|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.4525
73888484|NCT02900378|147309629|OTHER|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0445
73886696|NCT01116986|147307436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.117||||0.207|TWO_SIDED|95.0|0.941|1.325|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.||1.325|.941|.207
73886697|NCT01116986|147307436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.196||||0.041|TWO_SIDED|95.0|1.008|1.42|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.420|1.008|.041
73888485|NCT02900378|147309629|OTHER|||||||0.1158|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.1158
73888486|NCT02900378|147309629|OTHER|||||||0.3901|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3901
73888487|NCT02900378|147309629|OTHER|||||||0.7725|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.7725
74079526|NCT01592240|147712510|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19||||0.587|TWO_SIDED|95.0|-10.13|5.75|||Mixed models repeated measures analysis|||Week 24||5.75|-10.13|0.587
74079527|NCT01592240|147712511|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.66||||0.89|TWO_SIDED|95.0|-10.05|8.74|||Mixed models repeated measures analysis|||Week 12||8.74|-10.05|0.890
74079528|NCT01592240|147712511|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.32||||0.625|TWO_SIDED|95.0|-7.04|11.68|||Mixed models repeated measures analysis|||Week 12||11.68|-7.04|0.625
74079529|NCT01592240|147712511|SUPERIORITY_OR_OTHER||Adjusted mean difference|6.54||||0.172|TWO_SIDED|95.0|-2.86|15.94|||Mixed models repeated measures analysis|||Week 12||15.94|-2.86|0.172
74079530|NCT01592240|147712511|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.5||||0.109|TWO_SIDED|95.0|-0.79|7.8|||Mixed models repeated measures analysis|||Week 12||7.80|-0.79|0.109
74079531|NCT01592240|147712511|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.67||||0.218|TWO_SIDED|95.0|-1.6|6.94|||Mixed models repeated measures analysis|||Week 12||6.94|-1.60|0.218
74079532|NCT01592240|147712511|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.86||||0.812|TWO_SIDED|95.0|-8.01|6.29|||Mixed models repeated measures analysis|||Week 24||6.29|-8.01|0.812
74079533|NCT01592240|147712511|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15||||0.749|TWO_SIDED|95.0|-8.24|5.94|||Mixed models repeated measures analysis|||Week 24||5.94|-8.24|0.749
74079534|NCT01592240|147712511|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.82||||0.108|TWO_SIDED|95.0|-1.29|12.93|||Mixed models repeated measures analysis|||Week 24||12.93|-1.29|0.108
74079535|NCT01592240|147712511|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83||||0.752|TWO_SIDED|95.0|-5.99|4.34|||Mixed models repeated measures analysis|||Week 24||4.34|-5.99|0.752
74079536|NCT01592240|147712511|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.55||||0.55|TWO_SIDED|95.0|-6.68|3.57|||Mixed models repeated measures analysis|||Week 24||3.57|-6.68|0.550
74079537|NCT01592240|147712512|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19||||0.893|TWO_SIDED|95.0|-2.62|3.0|||Mixed models repeated measures analysis|||Week 12||3.00|-2.62|0.893
74079538|NCT01592240|147712512|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.33||||0.355|TWO_SIDED|95.0|-1.49|4.15|||Mixed models repeated measures analysis|||Week 12||4.15|-1.49|0.355
74079539|NCT01592240|147712512|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.64||||0.655|TWO_SIDED|95.0|-3.45|2.17|||Mixed models repeated measures analysis|||Week 12||2.17|-3.45|0.655
74079540|NCT01592240|147712512|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.49||||0.719|TWO_SIDED|95.0|-3.2|2.21|||Mixed models repeated measures analysis|||Week 12||2.21|-3.20|0.719
74079541|NCT01592240|147712512|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.41||||0.768|TWO_SIDED|95.0|-2.31|3.12|||Mixed models repeated measures analysis|||Week 12||3.12|-2.31|0.768
74079542|NCT01592240|147712512|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.66||||0.199|TWO_SIDED|95.0|-0.88|4.2|||Mixed models repeated measures analysis|||Week 24||4.20|-0.88|0.199
74079543|NCT01592240|147712512|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.9||||0.483|TWO_SIDED|95.0|-1.62|3.41|||Mixed models repeated measures analysis|||Week 24||3.41|-1.62|0.483
74079544|NCT01592240|147712512|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.03||||0.42|TWO_SIDED|95.0|-1.49|3.56|||Mixed models repeated measures analysis|||Week 24||3.56|-1.49|0.420
74079545|NCT01592240|147712512|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69||||0.488|TWO_SIDED|95.0|-2.67|1.28|||Mixed models repeated measures analysis|||Week 24||1.28|-2.67|0.488
74079546|NCT01592240|147712512|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39||||0.694|TWO_SIDED|95.0|-2.36|1.58|||Mixed models repeated measures analysis|||Week 24||1.58|-2.36|0.694
74079547|NCT01592240|147712513|SUPERIORITY_OR_OTHER||Adjusted mean difference|10.29||||0.527|TWO_SIDED|95.0|-21.73|42.3|||Mixed models repeated measures analysis|||Week 12||42.30|-21.73|0.527
74079548|NCT01592240|147712513|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.39||||0.981|TWO_SIDED|95.0|-31.49|32.26|||Mixed models repeated measures analysis|||Week 12||32.26|-31.49|0.981
74079549|NCT01592240|147712513|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54||||0.974|TWO_SIDED|95.0|-31.72|32.8|||Mixed models repeated measures analysis|||Week 12||32.80|-31.72|0.974
74079550|NCT01592240|147712513|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.58||||0.64|TWO_SIDED|95.0|-8.25|5.09|||Mixed models repeated measures analysis|||Week 12||5.09|-8.25|0.640
74079551|NCT01592240|147712513|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.08||||0.75|TWO_SIDED|95.0|-5.61|7.77|||Mixed models repeated measures analysis|||Week 12||7.77|-5.61|0.750
74079552|NCT01592240|147712513|SUPERIORITY_OR_OTHER||Adjusted mean difference|9.8||||0.509|TWO_SIDED|95.0|-19.41|39.01|||Mixed models repeated measures analysis|||Week 24||39.01|-19.41|0.509
74079553|NCT01592240|147712513|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.69||||0.855|TWO_SIDED|95.0|-31.76|26.38|||Mixed models repeated measures analysis|||Week 24||26.38|-31.76|0.855
74079554|NCT01592240|147712513|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.04||||0.839|TWO_SIDED|95.0|-26.39|32.47|||Mixed models repeated measures analysis|||Week 24||32.47|-26.39|0.839
73888488|NCT05465317|147309643|OTHER||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.65|0.86|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.86|0.65|<0.001
73886698|NCT01116986|147307436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.056||||0.536|TWO_SIDED|95.0|0.889|1.254|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal In-person Counseling During the Quit Attempt vs. Intensive In-person Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.254|.889|.536
73886699|NCT01116986|147307436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.049||||0.587|TWO_SIDED|95.0|0.883|1.246|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal Phone Counseling During the Quit Attempt vs. Intensive Phone Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.246|.883|.587
73886700|NCT01116986|147307436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078||||0.389|TWO_SIDED|95.0|0.909|1.278|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum vs. Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.||1.278|.909|.389
73886701|NCT03819114|147307440|EQUIVALENCE|Confidence Interval (CI) on Geometric Mean Ratio compared to reference interval (0.7, 1.43).|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.81|1.2|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.20|0.81|
73886702|NCT03819114|147307440|EQUIVALENCE|Confidence Interval on Geometric Mean Ratio compared to reference interval (0.7, 1.43).|Geometric Mean Ratio|1.34|||||TWO_SIDED|90.0|1.12|1.6|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.60|1.12|
73886703|NCT03819114|147307440|SUPERIORITY|Confidence Interval on Geometric Mean Ratio excluding 1.|Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|1.27|2.18|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.18|1.27|
73886704|NCT03819114|147307440|SUPERIORITY|Confidence Interval on Geometric Mean Ratio excluding 1.|Geometric Mean Ratio|0.59|||||TWO_SIDED|90.0|0.45|0.78|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.78|0.45|
73886705|NCT03819114|147307441|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Fisher Exact|||||||1.00
73886706|NCT03819114|147307442|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.17|||||TWO_SIDED|90.0|0.96|1.41|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.41|0.96|
73886707|NCT03819114|147307442|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.43|||||TWO_SIDED|90.0|1.21|1.69|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.69|1.21|
73886708|NCT03819114|147307442|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.51|||||TWO_SIDED|90.0|1.17|1.96|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.96|1.17|
73886709|NCT03819114|147307442|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.77|||||TWO_SIDED|90.0|0.6|1.0|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.00|0.60|
73886710|NCT03819114|147307443|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.37|||||TWO_SIDED|90.0|0.22|0.61|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.61|0.22|
73886711|NCT03819114|147307443|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.25|||||TWO_SIDED|90.0|0.15|0.44|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.44|0.15|
73886712|NCT03819114|147307443|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.11|||||TWO_SIDED|90.0|1.2|3.7|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||3.70|1.20|
73886713|NCT03819114|147307443|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.17|||||TWO_SIDED|90.0|0.09|0.32|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.32|0.09|
73886714|NCT03819114|147307444|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|4.03|||||TWO_SIDED|90.0|3.17|5.12|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||5.12|3.17|
73886715|NCT03819114|147307444|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.92|||||TWO_SIDED|90.0|2.33|3.65|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||3.65|2.33|
73886716|NCT03819114|147307444|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.82|1.52|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.52|0.82|
73886717|NCT03819114|147307444|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|3.62|||||TWO_SIDED|90.0|2.65|4.93|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||4.93|2.65|
73886718|NCT03819114|147307445|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.1|||||TWO_SIDED|90.0|1.66|2.65|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.65|1.66|
73886719|NCT03819114|147307445|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.89|1.39|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.39|0.89|
73886720|NCT03819114|147307445|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.2|||||TWO_SIDED|90.0|0.87|1.66|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.66|0.87|
73886721|NCT03819114|147307445|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.75|||||TWO_SIDED|90.0|1.24|2.45|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.45|1.24|
73886722|NCT03819114|147307446|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.52|||||TWO_SIDED|90.0|0.46|0.59|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.59|0.46|
73886723|NCT03819114|147307446|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.38|||||TWO_SIDED|90.0|0.34|0.43|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.43|0.34|
73886724|NCT03819114|147307446|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.25|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.25|0.93|
73886725|NCT03819114|147307446|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.48|||||TWO_SIDED|90.0|0.41|0.56|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.56|0.41|
73886726|NCT03819114|147307448|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.75|||||TWO_SIDED|90.0|0.6|0.93|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.93|0.60|
73886727|NCT03819114|147307448|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.1|||||TWO_SIDED|90.0|0.9|1.36|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.36|0.90|
73886728|NCT03819114|147307448|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.74|||||TWO_SIDED|90.0|1.29|2.33|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.33|1.29|
73886729|NCT03819114|147307448|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.43|||||TWO_SIDED|90.0|0.32|0.58|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.58|0.32|
73886730|NCT03819114|147307449|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.62|||||TWO_SIDED|90.0|0.49|0.78|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.78|0.49|
73886731|NCT03819114|147307449|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.71|1.1|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.10|0.71|
73886732|NCT03819114|147307449|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.77|||||TWO_SIDED|90.0|1.31|2.4|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.40|1.31|
73886733|NCT03819114|147307449|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.35|||||TWO_SIDED|90.0|0.26|0.47|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.47|0.26|
73886734|NCT03819114|147307450|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.5|||||TWO_SIDED|90.0|0.39|0.63|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.63|0.39|
73886735|NCT03819114|147307450|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.69|||||TWO_SIDED|90.0|0.55|0.86|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.86|0.55|
73886736|NCT03819114|147307450|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.8|||||TWO_SIDED|90.0|1.32|2.45|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.45|1.32|
73886737|NCT03819114|147307450|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.28|||||TWO_SIDED|90.0|0.2|0.38|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.38|0.20|
73886738|NCT01744977|147307451|NON_INFERIORITY_OR_EQUIVALENCE|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.300
73886739|NCT01744977|147307452|NON_INFERIORITY_OR_EQUIVALENCE|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.|Mean Difference (Final Values)|-0.7||||0.839|TWO_SIDED|95.0|-8.0|6.5||As measured at 12m|Mixed Models Analysis||This value summarizes the full 12 month period so Mean Difference (Final Values) is appropriate.|||6.5|-8.0|0.839
73886740|NCT04090203|147307459|SUPERIORITY||Percentage|75.0||||0.001|ONE_SIDED|95.0|40.0|||The test was performed at a one-sided significance level of 0.05.|Exact binomial test|The null hypothesis of the exact binomial test was that the percentage of patients who were successfully desensitized was less than or equal to 20%.|The percentage of successfully desensitized participants is presented with a one-sided 95% CI, obtained from the lower bound of the two-sided 90% Clopper-Pearson exact confidence interval.|The null hypothesis was that the percentage of patients who were successfully desensitized was less than or equal to 20%, and the alternative hypothesis was that this percentage was greater than 20%. Assuming 80% of study participants would be successfully desensitized, a sample size of 10 patients would provide greater than 90% power to reject the null hypothesis using a one-sided exact binomial test with a significance level of 0.05.|||40.0|0.001
73886741|NCT04225897|147307492|OTHER||Difference|-8.02|||||TWO_SIDED|95.0|-31.78|15.74||||||60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||15.74|-31.78|
73886742|NCT04225897|147307492|OTHER||Difference|-15.22|||||TWO_SIDED|95.0|-40.15|9.7|||Mixed effects analysis of covariance|||156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||9.70|-40.15|
73886743|NCT04225897|147307493|OTHER||Difference|14.82|||||TWO_SIDED|95.0|-91.68|121.33||||||60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||121.33|-91.68|
73886744|NCT04225897|147307493|OTHER||Difference|-31.19|||||TWO_SIDED|95.0|-143.96|81.57||||||156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||81.57|-143.96|
73886745|NCT02703597|147307538|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8|TWO_SIDED|95.0|0.32|4.2|||Mixed Models Analysis|||"Hypothesis: Participants in the GSA-ASPIRE-Network Group will be more likely to decrease in susceptibility to vaping than participants in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||4.20|0.32|0.80
73886746|NCT02703597|147307538|SUPERIORITY||Odds Ratio (OR)|0.17|||<|0.01|TWO_SIDED|95.0|0.06|0.43|||Mixed Models Analysis|||"Hypothesis: Participants in both arms will decrease in susceptibility to vaping over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||0.43|0.06|<0.01
73888489|NCT05465317|147309643|OTHER||Hazard Ratio (HR)|0.67||||0.001|TWO_SIDED|95.0|0.52|0.86|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.86|0.52|0.001
73888490|NCT05465317|147309643|OTHER||Hazard Ratio (HR)|0.79||||0.008|TWO_SIDED|95.0|0.67|0.94|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.94|0.67|0.008
73886747|NCT02703597|147307539|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7|TWO_SIDED|95.0|0.16|3.49|||Mixed Models Analysis|||"Hypothesis: Adolescents who participated in the GSA-ASPIRE-Network group will be more likely to decrease in susceptibility to using conventional tobacco than adolescents who participated in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||3.49|0.16|0.70
73886748|NCT02703597|147307539|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.01|TWO_SIDED|95.0|0.04|0.4|||Mixed Models Analysis|||"Hypothesis: Participants in both arms will decrease in susceptibility of using conventional tobacco over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||0.40|0.04|<0.01
73886749|NCT00089752|147307546|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was designed to achieve at least 80% power, using n 1⁄4 123 per group with an effect size of at least 0.36|Adjusted difference in mean change|-1.76||||0.09|TWO_SIDED|95.0|-3.8|0.3||a priori threshold was p\<0.05|ANCOVA|||Intent to Treat analysis with Last Observation Carried Forward.||0.3|-3.8|0.09
73886750|NCT01867671|147307552|SUPERIORITY||Odds Ratio (OR)|205.45|||<|0.0001|TWO_SIDED|95.0|24.0|1758.51|||Regression, Logistic|||||1758.51|24.00|<0.0001
73886751|NCT01867671|147307553|SUPERIORITY||Odds Ratio (OR)|27.82|||<|0.0031|TWO_SIDED|95.0|3.07|252.33|||Regression, Logistic|||||252.33|3.07|<0.0031
73886752|NCT01867671|147307554|OTHER|McNemar's Test|Simple Kappa Coefficient|0.162|||<|0.0001|TWO_SIDED|95.0|0.0628|0.2612|||McNemar|||||0.2612|0.0628|<0.0001
73886753|NCT01867671|147307555|SUPERIORITY||Mean Difference (Final Values)|1464.0|||<|0.0001|TWO_SIDED|95.0|944.0|1985.0|||Chi-squared|||||1985|944|<0.0001
73886754|NCT01523366|147307557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-167.2|STANDARD_ERROR_OF_MEAN|14.6|<|0.001|TWO_SIDED|95.0|-197.0|-137.4|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|||-137.4|-197.0|<.001
73886755|NCT01523366|147307558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-135.2|STANDARD_ERROR_OF_MEAN|18.23|<|0.001|TWO_SIDED|95.0|-172.3|-98.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 0.5 hours after the loading dose||-98.0|-172.3|<.001
73886756|NCT01523366|147307558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-168.9|STANDARD_ERROR_OF_MEAN|17.28|<|0.001|TWO_SIDED|95.0|-204.0|-133.7|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 8 hours after the loading dose||-133.7|-204.0|<.001
73886757|NCT01523366|147307559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-150.5|STANDARD_ERROR_OF_MEAN|12.97|<|0.001|TWO_SIDED|95.0|-176.9|-124.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 2 hours on Day 7 after multiple doses||-124.1|-176.9|<.001
73886758|NCT01523366|147307559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-140.2|STANDARD_ERROR_OF_MEAN|13.84|<|0.001|TWO_SIDED|95.0|-168.4|-111.9|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at 8 hours on Day 7 after multiple doses||-111.9|-168.4|<.001
73886759|NCT01523366|147307559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-130.6|STANDARD_ERROR_OF_MEAN|13.41|<|0.001|TWO_SIDED|95.0|-158.0|-103.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at end of dosing interval on Day 8||-103.2|-158.0|<.001
73886760|NCT00001959|147307622|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||H0: GFR Decrease during baseline period and treatment period are same||||<0.01
73886761|NCT00001959|147307623|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Kruskal-Wallis|||H0: Proteinuria during baseline and treatment periods are same||||0.16
73886762|NCT00979940|147307649|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Chi-squared|||||||0.97
73886763|NCT00632229|147307666|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.||||<0.05
73886764|NCT00632229|147307667|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.||||<0.05
73886765|NCT00737672|147307705|SUPERIORITY_OR_OTHER|||||||0.53|||||||Log Rank|||||||0.530
73886766|NCT00737672|147307708|SUPERIORITY_OR_OTHER|||||||0.475|||||||Log Rank|||||||0.475
73886767|NCT00737672|147307711|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value was calculated using Kaplan-Meier methodology with 24-month follow-up data.|Log Rank|||||||0.008
73886768|NCT00737672|147307712|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test of non-inferior proportions with delta = 0.15.|||||<|0.001|||||||Z-test|One-sided.||||||<0.001
73886769|NCT00737672|147307713|SUPERIORITY_OR_OTHER|||||||0.035|||||||Log Rank|||||||0.035
73886770|NCT00737672|147307716|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|Two-tailed.||||||1.000
73886771|NCT00737672|147307717|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|Two-tailed.||||||<0.001
73886772|NCT00737672|147307718|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|Two-tailed.||||||<0.001
73886773|NCT03818256|147307778|SUPERIORITY||Least Squares Mean Difference|0.11||||0.8511|TWO_SIDED|95.0|-1.03|1.24|||Mixed Models Analysis|||||1.24|-1.03|0.8511
73886774|NCT03818256|147307782|SUPERIORITY||Odds Ratio (OR)|0.82||||0.8169|TWO_SIDED|95.0|0.15|4.474|||Regression, Logistic|||||4.474|0.150|0.8169
73886775|NCT03818256|147307783|SUPERIORITY||Location shift|0.175||||0.9285|TWO_SIDED|95.0|-2.86|2.78|||Wilcoxon rank-sum test|||||2.780|-2.860|0.9285
73886776|NCT03818256|147307784|SUPERIORITY||Least squares mean difference|0.007||||0.5669|TWO_SIDED|95.0|-0.018|0.033|||Mixed Models Analysis|||||0.033|-0.018|0.5669
73888491|NCT05465317|147309644|OTHER||Hazard Ratio (HR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.91|0.60|0.005
73888565|NCT01929317|147309712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-1.95|1.24|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 6."|||1.24|-1.95|
73886777|NCT00911170|147307785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.014|TWO_SIDED|95.0|0.19|0.86|||Cochran-Mantel-Haenszel|The p-value is adjusted for the randomization stratification factors (chemotherapy regimen, geographic region, disease stage).|Odds ratio adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|The primary hypothesis was that the percentage of participants treated with study chemotherapy and bevacizumab who experience grade 3/4 febrile neutropenia (FN) would be lower in participants randomized to the pegfilgrastim arm compared to placebo arm. The study was designed to have at least 90% power at the 2-sided 0.05 significance level to detect a 6% difference in incidence of grade 3/4 FN from 9% to 3%, which is approximately a 66.7% relative reduction.||0.86|0.19|0.014
73886778|NCT00911170|147307786|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.704|TWO_SIDED|95.0|0.81|1.36|||Log Rank|P-values based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.36|0.81|0.704
73886779|NCT00911170|147307787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.552|TWO_SIDED|95.0|0.88|1.26|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.26|0.88|0.552
73886780|NCT00911170|147307788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.502|TWO_SIDED|95.0|0.88|1.29|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.29|0.88|0.502
73886781|NCT00911170|147307789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.683|TWO_SIDED|95.0|0.81|1.39|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \> 1.0 indicates a higher event rate for the pegfilgrastim arm relative to the placebo arm.|||1.39|0.81|0.683
73886782|NCT00911170|147307790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.312||95.0|0.29|1.49|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||1.49|0.29|0.312
73886783|NCT00911170|147307791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.18|||<|0.001||95.0|0.1|0.32|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||0.32|0.10|<.001
73886784|NCT00911170|147307792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.13|0.56|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||0.56|0.13|<.001
73888566|NCT01929317|147309712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-2.44|0.75|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 8."|||0.75|-2.44|
73886785|NCT04684836|147307796|SUPERIORITY|The analysis leveraged a difference-in-differences research design in an intent-to-treat framework, comparing outcomes for patients receiving care at high-telehealth practices with patients at comparable low-telehealth practices, before relative to after the onset of the pandemic (when telehealth use increased significantly).|Mean Difference (Net)|-0.0255||||0.0793|TWO_SIDED||||||Regression, Linear|All models included practice and year-quarter fixed effects, and clustered standard errors at the practice level.|This is the Unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|||||0.0793
73886786|NCT04684836|147307796|SUPERIORITY|Difference-in-differences model|Mean Difference (Net)|-0.0786||||0.5739|TWO_SIDED|||||This is the fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||||||0.5739
73886787|NCT04684836|147307797|SUPERIORITY||Mean Difference (Net)|-0.0014||||0.3261|TWO_SIDED|||||This is an adjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|Regression, Linear|||Difference-in-differences model||||0.3261
73886788|NCT04684836|147307797|SUPERIORITY||Mean Difference (Net)|0.0806|||<|0.01|TWO_SIDED|||||This is a fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences model||||<0.01
73886789|NCT04684836|147307798|SUPERIORITY||Mean Difference (Net)|-0.0217||||0.1101|TWO_SIDED|||||This is an adjusted unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|Regression, Linear|||Difference-in-differences||||0.1101
73886790|NCT04684836|147307798|SUPERIORITY||Mean Difference (Net)|0.5551||||0.4618|TWO_SIDED|||||This is a fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences||||0.4618
73886791|NCT04684836|147307800|SUPERIORITY||Mean Difference (Net)|-0.0012||||0.8577|TWO_SIDED|||||This is an unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction|Regression, Linear|||Difference-in-differences||||0.8577
73886792|NCT04684836|147307800|SUPERIORITY||Mean Difference (Net)|0.2014||||0.5954|TWO_SIDED|||||This is the fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences||||0.5954
73886793|NCT04226742|147307830|SUPERIORITY||Mean Difference (Net)|0.58||||0.79|TWO_SIDED|95.0|-3.71|4.88||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||4.88|-3.71|0.79
73886794|NCT04226742|147307831|SUPERIORITY||Mean Difference (Net)|0.9||||0.61|TWO_SIDED|95.0|-2.52|4.32||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||4.32|-2.52|.61
73886795|NCT04226742|147307832|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.088|TWO_SIDED|95.0|-0.05|0.68||Significance threshold of alpha = 0.05|Mixed Models Analysis|||||0.68|-0.05|0.088
73886796|NCT04226742|147307833|SUPERIORITY||Mean Difference (Final Values)|13.68||||0.142|TWO_SIDED|95.0|-4.62|31.99||Threshold for statistical significance of alpha = 0.05|Mixed Models Analysis|||||31.99|-4.62|0.142
73886797|NCT04226742|147307834|SUPERIORITY||Mean Difference (Final Values)|-6.87||||0.109|TWO_SIDED|95.0|-15.28|1.54||Threshold for statistical significance of alpha = .05|Mixed Models Analysis|||||1.54|-15.28|0.109
73886798|NCT04226742|147307835|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.736|TWO_SIDED|95.0|-6.92|4.89|||Mixed Models Analysis|||||4.89|-6.92|0.736
73886799|NCT02492763|147307836|SUPERIORITY||Difference in Least Squares Means|-0.39||||0.126|TWO_SIDED|95.0|-0.88|0.11|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.11|-0.88|0.126
73886800|NCT02492763|147307836|SUPERIORITY||Difference in Least Squares Means|0.6||||0.017|TWO_SIDED|95.0|0.11|1.08|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.08|0.11|0.017
73886801|NCT02492763|147307836|SUPERIORITY||Difference in Least Squares Means|-0.61||||0.018|TWO_SIDED|95.0|-1.12|-0.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-0.10|-1.12|0.018
73886802|NCT02492763|147307836|SUPERIORITY||Difference in Least Squares Means|0.37||||0.146|TWO_SIDED|95.0|-0.13|0.87|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.87|-0.13|0.146
73886803|NCT02492763|147307836|SUPERIORITY||Difference in the Least Squares Means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.49|-0.48||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-0.48|-1.49|<0.001
73886804|NCT02492763|147307839|SUPERIORITY||Difference in % vs Placebo|-2.3||||0.301|TWO_SIDED|95.0|-12.1|5.6|||Miettinen & Nurminen method|||||5.6|-12.1|0.301
73886805|NCT02492763|147307839|SUPERIORITY||Difference in % vs Placebo|2.2||||0.573|TWO_SIDED|95.0|-8.1|13.2|||Miettinen & Nurminen method|||||13.2|-8.1|0.573
73886806|NCT02492763|147307839|SUPERIORITY||Difference in % vs Liraglutide|-2.4||||0.295|TWO_SIDED|95.0|-12.4|5.5|||Miettinen & Nurminen method|||||5.5|-12.4|0.295
73886807|NCT02492763|147307839|SUPERIORITY||Difference in % vs Liraglutide|2.2||||0.587|TWO_SIDED|95.0|-8.4|13.2|||Miettinen & Nurminen method|||||13.2|-8.4|0.587
73886808|NCT02492763|147307840|SUPERIORITY||Difference in the LS Means vs. Placebo|6.9|||||TWO_SIDED|95.0|3.42|10.37|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|10.37|3.42|
73886809|NCT02492763|147307840|SUPERIORITY||Difference in LS Means vs. Liraglutide|3.84|||||TWO_SIDED|95.0|0.35|7.33|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|7.33|0.35|
74079555|NCT01592240|147712513|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.99||||0.392|TWO_SIDED|95.0|-6.57|2.59|||Mixed models repeated measures analysis|||Week 24||2.59|-6.57|0.392
73886810|NCT02492763|147307840|SUPERIORITY||Difference in LS Means vs. Placebo|7.7|||||TWO_SIDED|95.0|4.17|11.23|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|11.23|4.17|
73886811|NCT02492763|147307840|SUPERIORITY||Difference in LS Means vs. Liraglutide|4.65|||||TWO_SIDED|95.0|1.11|8.19|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|8.19|1.11|
73886812|NCT02492763|147307841|SUPERIORITY||Difference in Least Squares Means|-0.7||||0.285|TWO_SIDED|95.0|-2.0|0.6|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.6|-2.0|0.285
73886813|NCT02492763|147307841|SUPERIORITY||Difference in Least Squares Means|0.9||||0.183|TWO_SIDED|95.0|-0.4|2.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||2.2|-0.4|0.183
73886814|NCT02492763|147307841|SUPERIORITY||Difference in Least Squares Means|-1.8||||0.01|TWO_SIDED|95.0|-3.1|-0.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-0.4|-3.1|0.010
73886815|NCT02492763|147307841|SUPERIORITY||Difference in Least Squares Means|-0.2||||0.811|TWO_SIDED|95.0|-1.5|1.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.2|-1.5|0.811
73886816|NCT02492763|147307841|SUPERIORITY||Difference in the Least Squares Means|-1.6||||0.018|TWO_SIDED|95.0|-2.9|-0.3||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-0.3|-2.9|0.018
73886817|NCT02492763|147307842|SUPERIORITY||Difference in Least Squares Means|-8.6||||0.385|TWO_SIDED|95.0|-28.2|10.9|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||10.9|-28.2|0.385
73886818|NCT02492763|147307842|SUPERIORITY||Difference in Least Squares Means|29.1||||0.004|TWO_SIDED|95.0|9.7|48.6|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||48.6|9.7|0.004
73886819|NCT02492763|147307842|SUPERIORITY||Difference in Least Squares Means|-29.5||||0.004|TWO_SIDED|95.0|-49.6|-9.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-9.4|-49.6|0.004
73886820|NCT02492763|147307842|SUPERIORITY||Difference in Least Squares Means|8.3||||0.416|TWO_SIDED|95.0|-11.7|28.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||28.2|-11.7|0.416
74079556|NCT01592240|147712513|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.33||||0.565|TWO_SIDED|95.0|-5.91|3.24|||Mixed models repeated measures analysis|||Week 24||3.24|-5.91|0.565
74079557|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.964|||<|0.001|TWO_SIDED|95.0|3.997|56.02|||Regression, Logistic|||Week 12, Less than 100 mg/dL||56.020|3.997|<0.001
74079558|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.615|||<|0.001|TWO_SIDED|95.0|7.984|308.328|||Regression, Logistic|||Week 12, Less than 100 mg/dL||308.328|7.984|<0.001
74079559|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.842|||<|0.001|TWO_SIDED|95.0|3.674|44.892|||Regression, Logistic|||Week 12, Less than 100 mg/dL||44.892|3.674|<0.001
74079560|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.107||||0.01|TWO_SIDED|95.0|1.304|7.401|||Regression, Logistic|||Week 12, Less than 100 mg/dL||7.401|1.304|0.010
74079561|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.048|||<|0.001|TWO_SIDED|95.0|2.402|15.225|||Regression, Logistic|||Week 12, Less than 100 mg/dL||15.225|2.402|<0.001
74079562|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.773|||<|0.001|TWO_SIDED|95.0|3.932|41.495|||Regression, Logistic|||Week 24, Less than 100 mg/dL||41.495|3.932|<0.001
74079563|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.886|||<|0.001|TWO_SIDED|95.0|8.33|163.335|||Regression, Logistic|||Week 24, Less than 100 mg/dL||163.335|8.330|<0.001
74079564|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.75|||<|0.001|TWO_SIDED|95.0|5.741|75.006|||Regression, Logistic|||Week 24, Less than 100 mg/dL||75.006|5.741|<0.001
74079565|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.219||||0.001|TWO_SIDED|95.0|2.061|18.764|||Regression, Logistic|||Week 24, Less than 100 mg/dL||18.764|2.061|0.001
73886821|NCT02492763|147307842|SUPERIORITY||Difference in the Least Squares Means|-37.8|||<|0.001|TWO_SIDED|95.0|-57.5|-18.0||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-18.0|-57.5|<0.001
73886822|NCT02492763|147307846|SUPERIORITY||Difference in Least Squares Means|-3.7||||0.151|TWO_SIDED|95.0|-8.8|1.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.4|-8.8|0.151
73886823|NCT02492763|147307846|SUPERIORITY||Difference in Least Squares Means|-1.1||||0.682|TWO_SIDED|95.0|-6.2|4.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.1|-6.2|0.682
73886824|NCT02492763|147307846|SUPERIORITY||Difference in Least Squares Means|-2.5||||0.344|TWO_SIDED|95.0|-7.7|2.7|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||2.7|-7.7|0.344
73886825|NCT02492763|147307846|SUPERIORITY||Difference in Least Squares Means|0.2||||0.948|TWO_SIDED|95.0|-5.0|5.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||5.4|-5.0|0.948
73886826|NCT02492763|147307846|SUPERIORITY||Difference in the Least Squares Means|-2.7||||0.306|TWO_SIDED|95.0|-7.8|2.5||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||2.5|-7.8|0.306
73886827|NCT02492763|147307847|SUPERIORITY||Difference in Least Squares Means|1.5||||0.347|TWO_SIDED|95.0|-1.7|4.8|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.8|-1.7|0.347
73886828|NCT02492763|147307847|SUPERIORITY||Difference in Least Squares Means|-0.1||||0.963|TWO_SIDED|95.0|-3.3|3.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||3.2|-3.3|0.963
73886829|NCT02492763|147307847|SUPERIORITY||Difference in Least Squares Means|1.4||||0.394|TWO_SIDED|95.0|-1.9|4.7|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.7|-1.9|0.394
73886830|NCT02492763|147307847|SUPERIORITY||Difference in Least Squares Means|-0.2||||0.905|TWO_SIDED|95.0|-3.5|3.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||3.1|-3.5|0.905
73886831|NCT02492763|147307847|SUPERIORITY||Difference in the Least Squares Means|1.6||||0.325|TWO_SIDED|95.0|-1.6|4.9|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.9|-1.6|0.325
73886832|NCT01337960|147307848|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Fisher Exact|||||||< 0.01
73886833|NCT01337960|147307849|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||Fisher Exact|||||||<.02
73886834|NCT01337960|147307850|SUPERIORITY_OR_OTHER||||||=|0.17|TWO_SIDED||||||Fisher Exact|||||||=0.17
73886835|NCT01337960|147307851|SUPERIORITY_OR_OTHER||||||=|0.35|TWO_SIDED||||||Fisher Exact|||||||=0.35
73886836|NCT01285323|147307944|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.4063|||<|0.0001|TWO_SIDED|95.0|0.2819|0.5855||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.5855|0.2819|<0.0001
73886837|NCT01285323|147307945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.0397||0.0109|TWO_SIDED|95.0|0.023|0.179||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.179|0.023|0.0109
73886838|NCT01285323|147307946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.0317||0.0037|TWO_SIDED|95.0|0.03|0.155||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active-placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.155|0.030|0.0037
73886839|NCT01285323|147307947|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.937||0.0259|TWO_SIDED|95.0|0.025|0.393||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.393|0.025|0.0259
73886840|NCT01285323|147307948|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.196|STANDARD_ERROR_OF_MEAN|0.0664||0.0032|TWO_SIDED|95.0|-0.327|-0.066||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||-0.066|-0.327|0.0032
73886841|NCT01285323|147307949|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.486|||<|0.0001|TWO_SIDED|95.0|0.353|0.67|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.||0.670|0.353|<0.0001
73886842|NCT01285323|147307950|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.012||0.0037|TWO_SIDED|95.0|0.011|0.059||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.059|0.011|0.0037
73886843|NCT01285323|147307951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.1775||0.7263|TWO_SIDED|95.0|-0.411|0.287||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.287|-0.411|0.7263
73886844|NCT01285323|147307954|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.3893|||<|0.0001|TWO_SIDED|95.0|0.2621|0.5782||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.5782|0.2621|<0.0001
73886845|NCT01285323|147307954|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio|0.6686||||0.402|TWO_SIDED|95.0|0.2878|1.6479||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.6479|0.2878|0.4020
73886846|NCT02606643|147307965|SUPERIORITY_OR_OTHER|||||||0.814|||||||Chi-squared|||an alpha level of .05, and a level of power of 80%. These parameters required a sample size of 63 patients per group||||0.814
73886847|NCT03418714|147307977|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||T test on the change in network activity across all networks, from before to after salvinorin A administration.||||.006
73886848|NCT03418714|147307978|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||T test on the change in within- and between-network connectivity across all values, from before to after salvinorin A administration.||||.001
73886849|NCT03879772|147308012|SUPERIORITY|||||||0.95|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way analysis of variance (ANOVA).||||0.95
73886850|NCT03879772|147308012|SUPERIORITY|||||||0.78|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.78
73886851|NCT03879772|147308012|SUPERIORITY|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.98
73886852|NCT03879772|147308012|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
73886853|NCT03879772|147308012|SUPERIORITY|||||||0.82|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.82
73886854|NCT03879772|147308012|SUPERIORITY|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.98
73886855|NCT03879772|147308012|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
73886856|NCT03879772|147308012|SUPERIORITY|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.8
73886857|NCT03879772|147308012|SUPERIORITY|||||||0.02|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.02
73886858|NCT03879772|147308012|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
73886859|NCT03879772|147308013|SUPERIORITY|||||||0.56|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.56
73886860|NCT03879772|147308013|SUPERIORITY|||||||0.74|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.74
73886861|NCT03879772|147308013|SUPERIORITY|||||||0.68|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.68
73886862|NCT03879772|147308013|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
73886863|NCT03879772|147308013|SUPERIORITY|||||||0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.81
73886864|NCT03879772|147308013|SUPERIORITY|||||||0.33|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.33
73886865|NCT03879772|147308013|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
73886866|NCT03879772|147308013|SUPERIORITY|||||||0.46|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.46
73886867|NCT03879772|147308013|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
73886868|NCT03879772|147308013|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
73886869|NCT03879772|147308014|SUPERIORITY|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.8
73886870|NCT03879772|147308014|SUPERIORITY|||||||0.45|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.45
73886871|NCT03879772|147308014|SUPERIORITY|||||||0.12|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.12
73886872|NCT03879772|147308014|SUPERIORITY|||||||0.36|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.36
73886873|NCT03879772|147308014|SUPERIORITY|||||||0.6|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.6
73886874|NCT03879772|147308014|SUPERIORITY|||||||0.17|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.17
73886875|NCT03879772|147308014|SUPERIORITY|||||||0.23|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.23
73886876|NCT03879772|147308014|SUPERIORITY|||||||0.42|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.42
73886877|NCT03879772|147308014|SUPERIORITY|||||||0.09|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.09
73886878|NCT03879772|147308014|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
73886879|NCT03879772|147308015|SUPERIORITY|||||||0.03|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.03
73886880|NCT03879772|147308015|SUPERIORITY|||||||0.04|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.04
73886881|NCT03879772|147308015|SUPERIORITY|||||||0.08|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.08
73886882|NCT03879772|147308015|SUPERIORITY|||||||0.49|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.49
73886883|NCT03879772|147308015|SUPERIORITY|||||||0.93|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.93
73886884|NCT03879772|147308015|SUPERIORITY|||||||0.75|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.75
73886885|NCT03879772|147308015|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
73886886|NCT03879772|147308015|SUPERIORITY|||||||0.71|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.71
73886887|NCT03879772|147308015|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
73886888|NCT03879772|147308015|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
73886889|NCT03879772|147308016|SUPERIORITY|||||||0.16|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.16
73886890|NCT03879772|147308016|SUPERIORITY|||||||0.22|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.22
73886891|NCT03879772|147308016|SUPERIORITY|||||||0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.14
73886892|NCT03879772|147308016|SUPERIORITY|||||||0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.14
73886893|NCT03879772|147308016|SUPERIORITY|||||||0.85|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.85
73886894|NCT03879772|147308016|SUPERIORITY|||||||0.96|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.96
73886895|NCT03879772|147308016|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
73886896|NCT03879772|147308016|SUPERIORITY|||||||0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.81
73886897|NCT03879772|147308016|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
73886898|NCT03879772|147308016|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
73886899|NCT03879772|147308017|SUPERIORITY|||||||0.05|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.05
73886900|NCT03879772|147308017|SUPERIORITY|||||||0.07|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.07
73886901|NCT03879772|147308017|SUPERIORITY|||||||0.11|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.11
73886902|NCT03879772|147308017|SUPERIORITY|||||||0.31|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.31
73886903|NCT03879772|147308017|SUPERIORITY|||||||0.94|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.94
73886904|NCT03879772|147308017|SUPERIORITY|||||||0.73|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.73
73886905|NCT03879772|147308017|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
73886906|NCT03879772|147308017|SUPERIORITY|||||||0.79|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.79
73886907|NCT03879772|147308017|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
73886908|NCT03879772|147308017|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
73886909|NCT00728689|147308104|SUPERIORITY_OR_OTHER|||||||0.4591|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.||||0.4591
73886910|NCT00728689|147308105|SUPERIORITY_OR_OTHER|||||||0.0048|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-τ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0048
73886911|NCT00728689|147308106|SUPERIORITY_OR_OTHER|||||||0.0997|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-∞ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0997
73886912|NCT00728689|147308107|SUPERIORITY_OR_OTHER|||||||0.0422|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, Cmax was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0422
74079566|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.205||||0.001|TWO_SIDED|95.0|2.06|18.693|||Regression, Logistic|||Week 24, Less than 100 mg/dL||18.693|2.060|0.001
73886913|NCT00728689|147308108|SUPERIORITY_OR_OTHER|||||||0.8581|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.||||0.8581
73886914|NCT00929695|147308109|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
73886915|NCT00929695|147308109|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.4
73886916|NCT00929695|147308117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.14|1.33||||||||1.33|0.14|
73886917|NCT00929695|147308118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.009|TWO_SIDED|95.0|0.12|0.74|||Regression, Cox|||||0.74|0.12|0.009
73886918|NCT00929695|147308120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.95|TWO_SIDED|95.0|0.6|1.74|||Regression, Cox|||||1.74|0.6|0.95
73886919|NCT01352715|147308142|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Confidence interval estimation was stratified by randomization stratification factors using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified upper confidence bound for non-inferiority was 10 percentage points.|Cumulative probability difference|-3.4|||||TWO_SIDED|95.0|-8.4|1.5||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 48 cumulative probability of virologic failure with 95% confidence interval.||1.5|-8.4|
74079567|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.703|||<|0.001|TWO_SIDED|95.0|5.752|133.423|||Regression, Logistic|||Week 12, Less than 70 mg/dL||133.423|5.752|<0.001
74079568|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.177|||<|0.001|TWO_SIDED|95.0|13.783|367.564|||Regression, Logistic|||Week 12, Less than 70 mg/dL||367.564|13.783|<0.001
74079569|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|100.667|||<|0.001|TWO_SIDED|95.0|19.855|510.387|||Regression, Logistic|||Week 12, Less than 70 mg/dL||510.387|19.855|<0.001
74079570|NCT01592240|147712527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 70 mg/dL.||||<0.001
74079571|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.941|||<|0.001|TWO_SIDED|95.0|6.336|98.169|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||98.169|6.336|<0.001
74079572|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|80.004|||<|0.001|TWO_SIDED|95.0|18.094|353.742|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||353.742|18.094|<0.001
74079573|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|42.101|||<|0.001|TWO_SIDED|95.0|10.621|166.894|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||166.894|10.621|<0.001
74079574|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.7||||0.023|TWO_SIDED|95.0|1.396|98.075|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||98.075|1.396|0.023
73886920|NCT04109547|147308192|SUPERIORITY||Treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-1.3|-1.8|<0.0001
73886921|NCT04109547|147308192|SUPERIORITY||Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-1.2|-1.6|<0.0001
73886922|NCT04109547|147308192|SUPERIORITY||Treatment difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-0.8|-1.2|<0.0001
73886923|NCT01656408|147308258|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|3.8||0.978|TWO_SIDED|90.0|-6.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||6.6|-6.4|0.978
73886924|NCT01656408|147308258|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|3.2||0.005|TWO_SIDED|90.0|-15.4|-4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-4.5|-15.4|0.005
73886925|NCT01656408|147308258|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.1|STANDARD_ERROR_OF_MEAN|3.3||0|TWO_SIDED|90.0|-19.8|-8.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-8.4|-19.8|0.000
73886926|NCT01656408|147308258|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.4|STANDARD_ERROR_OF_MEAN|3.2||0.03|TWO_SIDED|90.0|-13.0|-1.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-1.9|-13.0|0.030
73886927|NCT01656408|147308258|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|4.9||0.484|TWO_SIDED|90.0|-4.9|11.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||11.9|-4.9|0.484
73886928|NCT01656408|147308258|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.0||0.169|TWO_SIDED|90.0|-9.3|0.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||0.9|-9.3|0.169
73886929|NCT01656408|147308258|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|3.6||0.023|TWO_SIDED|90.0|-14.9|-2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-2.6|-14.9|0.023
73886930|NCT01656408|147308258|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|4.6||0.605|TWO_SIDED|90.0|-10.4|5.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||5.5|-10.4|0.605
73886931|NCT01656408|147308259|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.9||0.635|TWO_SIDED|90.0|-4.9|8.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||8.7|-4.9|0.635
73886932|NCT01656408|147308259|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.8||0.077|TWO_SIDED|90.0|-10.1|-0.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.4|-10.1|0.077
73886933|NCT01656408|147308259|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|2.7||0.001|TWO_SIDED|90.0|-15.0|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-5.7|-15.0|0.001
73886934|NCT01656408|147308259|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|3.5||0.556|TWO_SIDED|90.0|-8.0|3.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.9|-8.0|0.556
73886935|NCT01656408|147308259|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.3||0.527|TWO_SIDED|90.0|-5.5|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||2.5|-5.5|0.527
73886936|NCT01656408|147308259|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.8||0.234|TWO_SIDED|90.0|-8.1|1.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||1.4|-8.1|0.234
73886937|NCT01656408|147308259|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|2.5||0.002|TWO_SIDED|90.0|-12.7|-4.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-4.1|-12.7|0.002
73886938|NCT01656408|147308259|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|3.1||0.726|TWO_SIDED|90.0|-4.2|6.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||6.5|-4.2|0.726
73886939|NCT01656408|147308260|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|4.5||0.855|TWO_SIDED|90.0|-9.0|7.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||7.3|-9.0|0.855
73886940|NCT01656408|147308260|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|8.1||0.658|TWO_SIDED|90.0|-10.8|18.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||18.1|-10.8|0.658
73886941|NCT01656408|147308260|SUPERIORITY_OR_OTHER||LS Mean Difference|6.3|STANDARD_ERROR_OF_MEAN|7.1||0.392|TWO_SIDED|90.0|-6.3|18.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||18.9|-6.3|0.392
73886942|NCT01656408|147308261|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.5||0.563|TWO_SIDED|90.0|-6.0|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.0|-6.0|0.563
74079575|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.841|||<|0.001|TWO_SIDED|95.0|4.527|299.817|||Regression, Logistic|||Week 24, Less than 70 mg/dL||299.817|4.527|<0.001
74079576|NCT01592240|147712527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
74079577|NCT01592240|147712527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
74079578|NCT01592240|147712527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
74079579|NCT01592240|147712527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
74079580|NCT01592240|147712527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
74079581|NCT01592240|147712527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
74079582|NCT01592240|147712527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
74079583|NCT01592240|147712527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
74079584|NCT01592240|147712527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
74079585|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.587||||1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL||||1.000
73886943|NCT01656408|147308261|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.9||0.381|TWO_SIDED|90.0|-0.8|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||2.5|-0.8|0.381
73886944|NCT01656408|147308261|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.0||0.387|TWO_SIDED|90.0|-1.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||5.2|-1.7|0.387
73886945|NCT01656408|147308262|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|4.7||0.357|TWO_SIDED|90.0|-3.9|12.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||12.8|-3.9|0.357
73886946|NCT01656408|147308262|SUPERIORITY_OR_OTHER||LS Mean Difference|7.4|STANDARD_ERROR_OF_MEAN|4.8||0.15|TWO_SIDED|90.0|-1.2|15.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||15.9|-1.2|0.150
73886947|NCT01656408|147308262|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|5.2||0.578|TWO_SIDED|90.0|-6.3|12.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||12.3|-6.3|0.578
73886948|NCT01656408|147308263|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|3.0||0.942|TWO_SIDED|90.0|-5.1|5.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||5.5|-5.1|0.942
74079586|NCT01592240|147712527|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL.||||<0.001
74079587|NCT01592240|147712527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.925||||1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL||||1.000
74079588|NCT05523895|147712594|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.52||0.2986|TWO_SIDED|95.0|-4.6|1.4|||Mixed Models Analysis|||||1.4|-4.6|0.2986
74079589|NCT05523895|147712594|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.49||0.2859|TWO_SIDED|95.0|-4.5|1.3|||Mixed Models Analysis|||||1.3|-4.5|0.2859
74079590|NCT01068821|147712659|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample size calculations (yielding 25 patients per group): two-sided 5% significance level and a power of 80% for detection of a 2 cm (SD 2.5 cm) difference. Continuous variables analyzed by Student's T-test and One way Analysis of Variance (ANOVA) with statistical significance: p value ≤ 0.05 or 95% Confidence Interval excluding one. Confirmation by Wilcoxon Rank-Sum/Mann-Whitney and Kruskal-Wallis tests. Categorical variables by Chi Square Test, confirmed by Fisher's Exact test.||||0.1
74079591|NCT01068821|147712660|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||Fischer's exact test, significance defined as p\<0.05||||0.5
74079592|NCT01642277|147712665|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.94||||0.052|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For symptom-severity score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size and non-normal distributions of symptom severity scores. The null hypothesis is that there is no difference between the two groups in symptom severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) symptom severity than the other group.||||.052
74079593|NCT01642277|147712665|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.06||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For coping score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of coping scores. The null hypothesis is that there is no difference between the two groups in coping, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) coping than the other group.||||.04
74079594|NCT01642277|147712665|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.176||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the concern score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outlier of the concern scores. The null hypothesis is that there is no difference between the two groups in their concern, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) concern than the other group.||||.03
74079595|NCT01642277|147712665|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|0.9||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the sleep score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of sleep scores. The null hypothesis is that there is no difference between the two groups in sleep scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) sleep scores than the other group.||||.37
74079596|NCT01642277|147712665|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.02||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For social score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of social scores. The null hypothesis is that there is no difference between the two groups in social scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) social scores than the other group.||||.04
74079597|NCT01642277|147712665|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.03||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the overall health related quality of life (HRQL) score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of HRQL scores. The null hypothesis is that there is no difference between the two groups in health related quality of life, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) health realted quality of life than the other group.||||.04
74079598|NCT01642277|147712666|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-0.74||||0.46|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the obstructive discomfort score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in obstructive discomfort, and and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) obstructive discomfort than the other group.||||.46
73886949|NCT01656408|147308263|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.7||0.627|TWO_SIDED|90.0|-4.8|8.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||8.5|-4.8|0.627
73886950|NCT01656408|147308263|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|1.9||0.046|TWO_SIDED|90.0|0.9|7.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.6|0.9|0.046
73886951|NCT01656408|147308264|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|3.8||0.025|TWO_SIDED|90.0|-18.0|-3.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-3.6|-18.0|0.025
73886952|NCT01656408|147308264|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.6||0.055|TWO_SIDED|90.0|-11.0|-1.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-1.1|-11.0|0.055
73886953|NCT01656408|147308265|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.6||0.999|TWO_SIDED|90.0|-4.4|4.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.4|-4.4|0.999
73886954|NCT01656408|147308265|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|3.2||0.934|TWO_SIDED|90.0|-5.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||5.2|-5.7|0.934
73886955|NCT01656408|147308265|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.4||0.547|TWO_SIDED|90.0|-3.7|7.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.9|-3.7|0.547
73886956|NCT01656408|147308265|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|2.9||0.906|TWO_SIDED|90.0|-5.2|4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||4.5|-5.2|0.906
73886957|NCT01656408|147308265|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.1||0.682|TWO_SIDED|90.0|-4.0|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||6.6|-4.0|0.682
73886958|NCT01656408|147308266|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|2.8||0.099|TWO_SIDED|90.0|-11.1|0.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||0.0|-11.1|0.099
73886959|NCT01656408|147308266|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.1||0.034|TWO_SIDED|90.0|-10.1|-1.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-1.7|-10.1|0.034
73886960|NCT01656408|147308267|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.0||0.281|TWO_SIDED|90.0|-6.5|1.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||1.6|-6.5|0.281
73886961|NCT01656408|147308267|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.3||0.333|TWO_SIDED|90.0|-1.2|4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||4.0|-1.2|0.333
73886962|NCT01656408|147308268|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|3.4||0.279|TWO_SIDED|90.0|-9.7|2.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||2.1|-9.7|0.279
73886963|NCT01656408|147308268|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.4||0.817|TWO_SIDED|90.0|-6.9|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||5.2|-6.9|0.817
73886964|NCT01656408|147308269|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.756|TWO_SIDED|90.0|-3.2|4.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.7|-3.2|0.756
73886965|NCT01656408|147308269|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|2.8||0.158|TWO_SIDED|90.0|-0.7|8.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||8.6|-0.7|0.158
73886966|NCT01656408|147308269|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.8||0.404|TWO_SIDED|90.0|-2.4|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.1|-2.4|0.404
73886967|NCT01656408|147308269|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.4||0.214|TWO_SIDED|90.0|-1.0|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||7.1|-1.0|0.214
73886968|NCT01656408|147308269|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|2.9||0.086|TWO_SIDED|90.0|0.2|10.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||10.0|0.2|0.086
73886969|NCT01656408|147308270|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|3.1||0.003|TWO_SIDED|90.0|-16.8|-5.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-5.9|-16.8|0.003
73886970|NCT01656408|147308270|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|3.5||0.105|TWO_SIDED|90.0|-12.3|0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||0.1|-12.3|0.105
73886971|NCT01656408|147308271|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|3.6||0.691|TWO_SIDED|90.0|-7.5|4.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.6|-7.5|0.691
73886972|NCT01656408|147308271|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|3.9||0.57|TWO_SIDED|90.0|-4.3|8.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||8.8|-4.3|0.570
73886973|NCT01656408|147308271|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|3.4||0.666|TWO_SIDED|90.0|-4.2|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.1|-4.2|0.666
73886974|NCT01656408|147308271|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|4.7||0.534|TWO_SIDED|90.0|-10.9|4.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||4.9|-10.9|0.534
73886975|NCT01656408|147308271|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|4.0||0.528|TWO_SIDED|90.0|-4.1|9.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||9.2|-4.1|0.528
73886976|NCT01656408|147308296|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.0||0.848|TWO_SIDED|90.0|-3.8|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.0|-3.8|0.848
73886977|NCT01656408|147308296|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|90.0|-8.0|-4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-4.0|-8.0|<0.0001
73886978|NCT01656408|147308296|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|3.5||0.025|TWO_SIDED|90.0|-14.4|-2.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-2.4|-14.4|0.025
73886979|NCT01656408|147308296|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.8||0.044|TWO_SIDED|90.0|-7.0|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.8|-7.0|0.044
73886980|NCT01656408|147308296|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.0||0.139|TWO_SIDED|90.0|-0.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||6.6|-0.4|0.139
73886981|NCT01656408|147308296|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|2.5||0.088|TWO_SIDED|90.0|-8.9|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-0.2|-8.9|0.088
73886982|NCT01656408|147308296|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|2.2||0.023|TWO_SIDED|90.0|-9.3|-1.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-1.6|-9.3|0.023
73886983|NCT01656408|147308296|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.4||0.878|TWO_SIDED|90.0|-4.5|3.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||3.8|-4.5|0.878
73886984|NCT01656408|147308297|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|3.2||0.512|TWO_SIDED|90.0|-3.4|7.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.7|-3.4|0.512
73886985|NCT01656408|147308297|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|3.0||0.429|TWO_SIDED|90.0|-7.5|2.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.7|-7.5|0.429
73886986|NCT01656408|147308297|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|2.9||0.166|TWO_SIDED|90.0|-9.3|0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.8|-9.3|0.166
74079599|NCT01642277|147712666|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.8||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the irritative score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in irritation, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) irritation than the other group.||||.07
73886987|NCT01656408|147308297|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|3.8||0.591|TWO_SIDED|90.0|-8.6|4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.5|-8.6|0.591
73886988|NCT01656408|147308298|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|4.7||0.248|TWO_SIDED|90.0|-2.5|13.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||13.5|-2.5|0.248
74079600|NCT01642277|147712666|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.59||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the stress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in stress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) stress than the other group.||||.11
74079601|NCT01642277|147712666|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.69||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the urinary distress inventory score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in urinary distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) urinary distress than the other group.||||.09
74079602|NCT01642277|147712666|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.68||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the general score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in general pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) general pelvic floor disease severity than the other group.||||.09
74079603|NCT01642277|147712666|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-0.23||||0.82|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the anterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in anterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) anterior pelvic floor disease severity than the other group.||||.82
74079604|NCT01642277|147712666|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.92||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the posterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in posterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) posterior pelvic floor disease severity than the other group.||||.06
74079605|NCT01642277|147712666|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.85||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the pelvic organ prolapse distress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in pelvic organ prolapse distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) pelvic organ prolapse distress than the other group.||||.07
74079606|NCT00908128|147712671|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on lon-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.96||||||90.0|82.4|100.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.41|82.40|
74079607|NCT00908128|147712672|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.16||||||90.0|96.24|102.16|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.16|96.24|
74079608|NCT00908128|147712673|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.78||||||90.0|95.76|101.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.89|95.76|
74079609|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% Confidence Interval (CI) for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.751|1.03||||||Serogroup A: Lot 1 vs Lot 2||1.03|0.751|
74079610|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.985|||||TWO_SIDED|95.0|0.843|1.15||||||Serogroup A: Lot 2 vs Lot 3||1.15|0.843|
74079611|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.867|||||TWO_SIDED|95.0|0.74|1.02||||||Serogroup A: Lot 1 vs Lot 3||1.02|0.740|
74079612|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.07|||||TWO_SIDED|95.0|0.888|1.29||||||Serogroup C: Lot 1 vs Lot 2||1.29|0.888|
74079613|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.866|||||TWO_SIDED|95.0|0.714|1.05||||||Serogroup C: Lot 2 vs Lot 3||1.05|0.714|
74079614|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.927|||||TWO_SIDED|95.0|0.766|1.12||||||Serogroup C: Lot 1 vs Lot 3||1.12|0.766|
73886989|NCT01656408|147308298|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|2.9||0.836|TWO_SIDED|90.0|-5.6|4.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.4|-5.6|0.836
73886990|NCT01656408|147308298|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|3.2||0.109|TWO_SIDED|90.0|-10.7|0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.1|-10.7|0.109
73886991|NCT01656408|147308298|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|3.7||0.785|TWO_SIDED|90.0|-5.4|7.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.5|-5.4|0.785
73886992|NCT01656408|147308299|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.2||0.365|TWO_SIDED|90.0|-2.5|8.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.3|-2.5|0.365
73886993|NCT01656408|147308299|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.9||0.424|TWO_SIDED|90.0|-7.4|2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.6|-7.4|0.424
73886994|NCT01656408|147308299|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|3.2||0.025|TWO_SIDED|90.0|-13.3|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.2|-13.3|0.025
73886995|NCT01656408|147308299|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|3.1||0.475|TWO_SIDED|90.0|-7.5|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.0|-7.5|0.475
73886996|NCT01656408|147308300|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|3.4||0.715|TWO_SIDED|90.0|-7.4|4.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.8|-7.4|0.715
73886997|NCT01656408|147308300|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|4.3||0.338|TWO_SIDED|90.0|-11.9|3.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||3.4|-11.9|0.338
73886998|NCT01656408|147308300|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.4||0.281|TWO_SIDED|90.0|-10.0|2.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||2.3|-10.0|0.281
73886999|NCT01656408|147308301|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.8||0.317|TWO_SIDED|90.0|-2.1|7.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.9|-2.1|0.317
73887000|NCT01656408|147308302|SUPERIORITY_OR_OTHER||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|3.6||0.09|TWO_SIDED|90.0|0.2|13.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||13.2|0.2|0.090
73887001|NCT01656408|147308303|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.0||0.128|TWO_SIDED|90.0|-0.3|6.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.8|-0.3|0.128
73887002|NCT01656408|147308304|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|3.1||0.477|TWO_SIDED|90.0|-7.9|3.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.3|-7.9|0.477
73887003|NCT01656408|147308304|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|3.0||0.09|TWO_SIDED|90.0|-11.0|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||-0.2|-11.0|0.090
73887004|NCT01656408|147308304|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|3.0||0.028|TWO_SIDED|90.0|-13.0|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||-2.2|-13.0|0.028
73887005|NCT01656408|147308305|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.5||0.877|TWO_SIDED|90.0|-4.9|4.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.1|-4.9|0.877
73887006|NCT01656408|147308306|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|4.6||0.827|TWO_SIDED|90.0|-9.3|7.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.2|-9.3|0.827
73887007|NCT01656408|147308307|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|3.5||0.161|TWO_SIDED|90.0|-11.4|1.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.0|-11.4|0.161
73887008|NCT01656408|147308308|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|4.4||0.046|TWO_SIDED|90.0|-18.8|-2.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-2.3|-18.8|0.046
73887009|NCT01656408|147308308|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.9|STANDARD_ERROR_OF_MEAN|2.3||0.001|TWO_SIDED|90.0|-17.2|-8.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-8.6|-17.2|0.001
73887010|NCT01656408|147308309|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|2.6||0.91|TWO_SIDED|90.0|-4.6|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.2|-4.6|0.910
73887011|NCT01656408|147308310|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|3.6||0.906|TWO_SIDED|90.0|-6.6|5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.7|-6.6|0.906
73887012|NCT01656408|147308311|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.4||0.87|TWO_SIDED|90.0|-4.4|3.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.7|-4.4|0.870
73887013|NCT01656408|147308312|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|90.0|-5.0|-3.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-3.7|-5.0|<0.0001
73887014|NCT01656408|147308312|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|1.2||0.001|TWO_SIDED|90.0|-10.7|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-5.7|-10.7|0.001
73887015|NCT01656408|147308313|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.0||0.038|TWO_SIDED|90.0|-4.9|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.8|-4.9|0.038
73887016|NCT01656408|147308314|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.8||0.238|TWO_SIDED|90.0|-6.0|1.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.2|-6.0|0.238
73887017|NCT01656408|147308315|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.0||0.048|TWO_SIDED|90.0|-4.7|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.6|-4.7|0.048
73887018|NCT01656408|147308316|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.83|TWO_SIDED|90.0|-3.2|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||2.5|-3.2|0.830
73887019|NCT01656408|147308316|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.9||0.063|TWO_SIDED|90.0|-10.8|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-0.7|-10.8|0.063
73887020|NCT01656408|147308317|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|3.7||0.892|TWO_SIDED|90.0|-7.1|6.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.1|-7.1|0.892
73887021|NCT01656408|147308318|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|3.1||0.571|TWO_SIDED|90.0|-3.4|6.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.9|-3.4|0.571
73887022|NCT01656408|147308319|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.8||0.816|TWO_SIDED|90.0|-5.4|4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.0|-5.4|0.816
73887023|NCT01656408|147308320|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|2.2||0.061|TWO_SIDED|90.0|-8.4|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.6|-8.4|0.061
73887024|NCT01656408|147308320|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|2.6||0.161|TWO_SIDED|90.0|-8.3|0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||0.7|-8.3|0.161
73887025|NCT01656408|147308321|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.0||0.786|TWO_SIDED|90.0|-4.0|2.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.9|-4.0|0.786
73887026|NCT01656408|147308322|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|3.3||0.263|TWO_SIDED|90.0|-9.3|1.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.8|-9.3|0.263
73887027|NCT01656408|147308323|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.0||0.565|TWO_SIDED|90.0|-4.4|2.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.1|-4.4|0.565
73887028|NCT00871975|147308324|SUPERIORITY_OR_OTHER||Sensitivity (percent)|80.6|||||TWO_SIDED||||||||We found an 80.6% sensitivity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.||||
73887029|NCT00871975|147308324|SUPERIORITY_OR_OTHER||Specificity (percent)|28.1|||||TWO_SIDED||||||||We found a 28.1% specificity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.||||
73888567|NCT01929317|147309712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|||||TWO_SIDED|95.0|-2.73|0.58|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 12."|||0.58|-2.73|
73887030|NCT03592186|147308338|SUPERIORITY|In zero-inflated distributions, two outcomes can be specified: 1) probability of being an excess zero (falling outside expected negative binomial distribution), and 2) count value, if not an excess zero. Our focal effect of interest was Time\*Condition in the count distribution, i.e. effect of condition over time on predicting the percent of days used greater than zero.|Risk Ratio (RR)|1.15|STANDARD_ERROR_OF_MEAN|2.57||0.12|TWO_SIDED|95.0|0.97|1.36|||Mixed Models Analysis|||Mixed models with zero-inflated distributions evaluated whether there was a Time\*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used. We tested the primary outcome (percent of days of use over the past 90 days, adjusted for time in a controlled environment) for overall number of days of use.||1.36|.97|.12
73887031|NCT03592186|147308339|SUPERIORITY||Risk Ratio (RR)|-0.1|STANDARD_ERROR_OF_MEAN|0.34||0.19|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|||Mixed models using a linear distribution evaluated whether change in substance-related problems differed by condition. The focal effect was a Time\*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used.||.07|-.34|.19
73887032|NCT03592186|147308340|SUPERIORITY||Chi-square value|0.01||||0.92|TWO_SIDED||||||Chi-squared|||Comparison of the count of positive urine screens by condition at 12 weeks||||.92
73887033|NCT00817843|147308344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.295||0.766||95.0|||||ANOVA|||"Between treatment difference in the change in FMD from the fasting to the post-fat load state.~Null hypothesis was that combination therapy (simvastatin/ezetimibe) would protect the FMD in the post-fat load phase and would therefore be associated with a smaller drop in FMD~Power calculation was based on the results from a pilot study. To detect a 1.0% difference between treatments with a SD of 2.7% and a power of 90% (alfa 0.05, two tailed) 80 evaluable patients were needed."||||0.766
73887034|NCT00307801|147308345|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||inverting 2 one-sided tests|||||||< 0.0001
73887035|NCT03431259|147308399|SUPERIORITY|||||||0.0574|||||||Chi-squared|||||||.0574
73887036|NCT03431259|147308399|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.570
73887037|NCT00551642|147308401|OTHER||Odds Ratio (OR)|1.05||||0.734|TWO_SIDED||||||Wald Chi-square|||||||0.7340
73887038|NCT02668653|147308424|OTHER||Hazard Ratio (HR)|0.776||||0.0324|TWO_SIDED|95.0|0.615|0.979|||Log Rank|Stratification factors include region, age, and WBC count at the time of diagnosis of AML.||||0.979|0.615|0.0324
73887039|NCT01294553|147308434|SUPERIORITY_OR_OTHER||Percentage of participants|15.4|||||TWO_SIDED|95.0|12.8|18.1|||||The estimated value represents the percentage of participants with an adverse event.|||18.1|12.8|
73887040|NCT00926237|147308441|SUPERIORITY||Mean Difference (Final Values)|-5.74||||0.04|ONE_SIDED|||||t value = -1.40|Mixed Models Analysis||1Hz active rTMS - Sham rTMS|||||.04
73887041|NCT00926237|147308441|SUPERIORITY||Mean Difference (Final Values)|-6.77||||0.02|ONE_SIDED|||||t value = -2.03|Mixed Models Analysis||10 Hz active rTMS - Sham rTMS|||||.02
73887042|NCT00926237|147308441|SUPERIORITY||Mean Difference (Final Values)|-4.73||||0.2|ONE_SIDED|||||t value = -1..28|Mixed Models Analysis||10 Hz washout - sham washout period|||||.20
73887043|NCT00926237|147308441|SUPERIORITY||Mean Difference (Final Values)|-5.19||||0.19|ONE_SIDED|||||t value = -1.29|Mixed Models Analysis||1Hz washout - sham washout|||||.19
73887044|NCT02667119|147308446|SUPERIORITY||F|4.75||||0.041|TWO_SIDED||||||ANCOVA|Controlled for baseline scores on the National Stressful Events PTSD Scale||Compared the two groups at 3 months post-baseline||||.041
73887045|NCT02667119|147308447|SUPERIORITY||F|6.89||||0.016|TWO_SIDED||||||ANCOVA|Controlled for baseline score on the National Stressful Events PTSD Scale||||||.016
73887046|NCT02667119|147308448|SUPERIORITY||t|-2.19||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||.04
73887047|NCT02667119|147308449|SUPERIORITY||F|2.25||||0.148|TWO_SIDED|||||Controlling for baseline score on the Center for Epidemiological Studies-Depressed Mood scale|ANCOVA|||||||.148
73887048|NCT02667119|147308450|SUPERIORITY||F|4.64||||0.043|TWO_SIDED||||||ANCOVA|Controlling for baseline score on the Center for Epidemiological Studies-Depressed Mood scale||||||.043
73887049|NCT02667119|147308451|SUPERIORITY||F|1.4||||0.25|TWO_SIDED|||||Controlling for baseline score on the Quality of Life Scale|ANCOVA|||||||.250
73887050|NCT02667119|147308452|SUPERIORITY||F|0.45||||0.508|TWO_SIDED||||||ANCOVA|Controlling for baseline score on the Quality of Life Scale||||||.508
73887051|NCT03994081|147308453|SUPERIORITY|||||||0.332|||||||t-test, 2 sided|||||||0.332
73887052|NCT03994081|147308454|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.790
73887053|NCT03994081|147308455|SUPERIORITY|||||||0.464|||||||Pearson's correlation|||||||0.464
73887054|NCT03994081|147308455|SUPERIORITY|||||||0.765|||||||Pearson's correlation|||||||0.765
73887055|NCT03994081|147308456|SUPERIORITY|||||||0.072|||||||Pearson's correlation|||||||0.072
73887056|NCT03994081|147308456|SUPERIORITY|||||||0.811|||||||Pearson's correlation|||||||0.811
73887057|NCT02059278|147308469|EQUIVALENCE|Analysis at 8 am on Day 15|Mean Difference (Final Values)|0.781||||0.0091|TWO_SIDED|95.0|0.195|1.366|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.366|0.195|0.0091
73888492|NCT05465317|147309644|OTHER||Hazard Ratio (HR)|0.61||||0.02|TWO_SIDED|95.0|0.41|0.91|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.91|0.41|0.02
74079615|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.869|1.19||||||Serogroup Y: Lot 1 vs Lot 2||1.19|0.869|
74079616|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.961|||||TWO_SIDED|95.0|0.816|1.13||||||Serogroup Y: Lot 2 vs Lot 3||1.13|0.816|
74079617|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.975|||||TWO_SIDED|95.0|0.829|1.15||||||Serogroup Y: Lot 1 vs Lot 3||1.15|0.829|
74079618|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.04|||||TWO_SIDED|95.0|0.878|1.22||||||Serogroup W: Lot 1 vs Lot 2||1.22|0.878|
74079619|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.936|||||TWO_SIDED|95.0|0.791|1.11||||||Serogroup W: Lot 2 vs Lot 3||1.11|0.791|
74079620|NCT02842853|147712675|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.818|1.15||||||Serogroup W: Lot 1 vs Lot 3||1.15|0.818|
74079621|NCT02842853|147712676|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.1|||||TWO_SIDED|95.0|14.8|23.5||||||Serogroup A||23.5|14.8|
74079622|NCT02842853|147712676|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|40.9|||||TWO_SIDED|95.0|36.7|45.0||||||Serogroup C||45|36.7|
74079623|NCT02842853|147712676|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|18.1|||||TWO_SIDED|95.0|14.5|21.9||||||Serogroup Y||21.9|14.5|
74079624|NCT02842853|147712676|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.1|||||TWO_SIDED|95.0|14.9|23.3||||||Serogroup W||23.3|14.9|
74079625|NCT02842853|147712677|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.6|||||TWO_SIDED|95.0|13.5|25.8||||||Serogroup A||25.8|13.5|
74079626|NCT02842853|147712677|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|41.1|||||TWO_SIDED|95.0|35.0|46.9||||||Serogroup C||46.9|35.0|
74079627|NCT02842853|147712677|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|27.4|||||TWO_SIDED|95.0|21.7|33.3||||||Serogroup Y||33.3|21.7|
74079628|NCT02842853|147712677|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|26.8|||||TWO_SIDED|95.0|20.7|32.9||||||Serogroup W||32.9|20.7|
74079629|NCT02842853|147712678|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|18.7|||||TWO_SIDED|95.0|12.5|24.9||||||Serogroup A||24.9|12.5|
74079630|NCT02842853|147712678|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|42.3|||||TWO_SIDED|95.0|36.6|48.0||||||Serogroup C||48.0|36.6|
74079631|NCT02842853|147712678|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|10.0|||||TWO_SIDED|95.0|6.18|14.5||||||Serogroup Y||14.5|6.18|
74079632|NCT02842853|147712678|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|12.5|||||TWO_SIDED|95.0|7.22|18.2||||||Serogroup W||18.2|7.22|
74079633|NCT02842853|147712679|OTHER||Percentage Difference|-5.4|||||TWO_SIDED|95.0|-9.59|-1.16||||||Serogroup A: Lot 1 vs Lot 2||-1.16|-9.59|
74079634|NCT02842853|147712679|OTHER||Percentage Difference|2.9|||||TWO_SIDED|95.0|-1.3|7.01||||||Serogroup A: Lot 2 vs Lot 3||7.01|-1.3|
74079635|NCT02842853|147712679|OTHER||Percentage Difference|-2.5|||||TWO_SIDED|95.0|-6.78|1.74||||||Serogroup A: Lot 1 vs Lot 3||1.74|-6.78|
74079636|NCT02842853|147712679|OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-1.58|4.28||||||Serogroup C: Lot 1 vs Lot 2||4.28|-1.58|
74079637|NCT02842853|147712679|OTHER||Percentage Difference|2.4|||||TWO_SIDED|95.0|-0.74|5.54||||||Serogroup C: Lot 2 vs Lot 3||5.54|-0.740|
74079638|NCT02842853|147712679|OTHER||Percentage Difference|3.7|||||TWO_SIDED|95.0|0.708|6.79||||||Serogroup C: Lot 1 vs Lot 3||6.79|0.708|
74079639|NCT02842853|147712679|OTHER||Percentage Difference|0.5|||||TWO_SIDED|95.0|-2.14|3.07||||||Serogroup Y: Lot 1 vs Lot 2||3.07|-2.14|
74079640|NCT02842853|147712679|OTHER||Percentage Difference|2.0|||||TWO_SIDED|95.0|-0.763|4.79||||||Serogroup Y: Lot 2 vs Lot 3||4.79|-0.763|
74079641|NCT02842853|147712679|OTHER||Percentage Difference|2.5|||||TWO_SIDED|95.0|-0.248|5.2||||||Serogroup Y: Lot 1 vs Lot 3||5.20|-0.248|
74079642|NCT02842853|147712679|OTHER||Percentage Difference|0.8|||||TWO_SIDED|95.0|-3.0|4.54||||||Serogroup W: Lot 1 vs Lot 2||4.54|-3.00|
74079643|NCT02842853|147712679|OTHER||Percentage Difference|2.0|||||TWO_SIDED|95.0|-1.84|5.89||||||Serogroup W: Lot 2 vs Lot 3||5.89|-1.84|
74079644|NCT02842853|147712679|OTHER||Percentage Difference|2.8|||||TWO_SIDED|95.0|-1.02|6.61||||||Serogroup W: Lot 1 vs Lot 3||6.61|-1.02|
74079645|NCT02842853|147712680|OTHER||GMT Ratio|1.93|||||TWO_SIDED|95.0|1.67|2.24||||||Serogroup A||2.24|1.67|
74079646|NCT02842853|147712680|OTHER||GMT Ratio|8.05|||||TWO_SIDED|95.0|6.58|9.84||||||Serogroup C||9.84|6.58|
74079647|NCT02842853|147712680|OTHER||GMT Ratio|3.22|||||TWO_SIDED|95.0|2.71|3.84||||||Serogroup Y||3.84|2.71|
74079648|NCT02842853|147712680|OTHER||GMT Ratio|1.9|||||TWO_SIDED|95.0|1.61|2.24||||||Serogroup W||2.24|1.61|
74079649|NCT03317444|147712703|SUPERIORITY||Treatment difference in % of subjects|36.7|||<|0.0001|TWO_SIDED|95.0|23.5|48.9|||Fisher Exact|||% Subjects Who Met Endpoint (≥ 4 mEq/L Change from Baseline Serum Bicarbonate or Serum Bicarbonate in the Normal Range \[22 - 29 mEq/L\]): TRC101-Placebo||48.9|23.5|< 0.0001
74079650|NCT03317444|147712703|SUPERIORITY||Treatment difference in % of subjects|34.5|||<|0.0001|TWO_SIDED|95.0|21.2|46.8|||Fisher Exact|||% Subjects with ≥ 4 mEq/L Change from Baseline in Serum Bicarbonate: TRC101-Placebo||46.8|21.2|< 0.0001
74079651|NCT03317444|147712703|SUPERIORITY||Treatment difference in % of subjects|33.1|||<|0.0001|TWO_SIDED|95.0|19.7|45.6|||Fisher Exact|||% Subjects with Serum Bicarbonate in the Normal Range (22 - 29 mEq/L): TRC101-Placebo||45.6|19.7|< 0.0001
74079652|NCT03317444|147712704|SUPERIORITY||Treatment difference in LS means|2.63|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|1.77|3.5|||Mixed-effect repeated measures model||Standard error presented above is for the LS mean.|Least Squares (LS) Mean Change from Baseline: TRC101-Placebo||3.5|1.77|< 0.0001
74079653|NCT02944617|147712706|OTHER|||||||1|||||||Fisher Exact|||||||1.00
74079654|NCT02944617|147712708|OTHER|||||||0.077|||||||Log Rank|||||||0.077
74079655|NCT00506831|147712745|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||Null hypothesis is that the mRSS is not significantly different at month 6 compared with baseline. Paired t-test was used to compare the mean mRSS at month 6 compared with baseline.||||0.005
74079656|NCT02488239|147712757|OTHER||||||<|0.001|||||||exact binomial rate|||||||<0.001
74079657|NCT02488239|147712758|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
74079658|NCT00608322|147712768|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.03||||0.37|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.37
74079659|NCT00834444|147712770|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.9||||||90.0|87.8|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107|87.8|
74079660|NCT00834444|147712771|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.9|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|97.9|
74079661|NCT00834444|147712772|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|97.7|
74079662|NCT02213263|147712794|EQUIVALENCE|Equivalence was tested within the pre-specified margins of (-16%, 16%) 95% confidence interval.|Difference in ORR|4.66|||||TWO_SIDED|95.0|-4.16|13.47||||||Difference in ORR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.||13.47|-4.16|
74079663|NCT02213263|147712800|SUPERIORITY||Hazard Ratio (HR)|1.163||||0.45|TWO_SIDED|95.0|0.786|1.72||A log-rank test stratified by follicular lymphoma international prognostic index 2 (FLIPI2) risk was used to compare the treatment groups with respect to TTF at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its confidence intervals (CIs) were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||1.720|0.786|0.450
74079664|NCT02213263|147712801|SUPERIORITY||Hazard Ratio (HR)|1.393||||0.189|TWO_SIDED|95.0|0.847|2.291|||Log Rank|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to PFS at a 2-sided alpha level of 0.05.|Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||2.291|0.847|0.189
73888568|NCT01929317|147309713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|||||TWO_SIDED|95.0|-8.77|6.71|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 2."|||6.71|-8.77|
73887058|NCT02059278|147308469|EQUIVALENCE|Analysis at 10 am on Day 15|Mean Difference (Final Values)|0.664||||0.0098|TWO_SIDED|95.0|0.161|1.167|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.167|0.161|0.0098
73888569|NCT01929317|147309713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-7.94|8.22|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 4."|||8.22|-7.94|
73887059|NCT02059278|147308469|EQUIVALENCE|Analysis at 4 pm on Day 15|Mean Difference (Final Values)|0.542||||0.0398|TWO_SIDED|95.0|0.025|1.058|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.058|0.025|0.0398
73887060|NCT02059278|147308469|EQUIVALENCE|Analysis at 8 am on Day 42|Mean Difference (Final Values)|0.478||||0.1008|TWO_SIDED|95.0|-0.093|1.05|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.050|-0.093|0.1008
73887061|NCT02059278|147308469|EQUIVALENCE|Analysis at 10 am on Day 42|Mean Difference (Final Values)|0.505||||0.0558|TWO_SIDED|95.0|-0.013|1.024|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.024|-0.013|0.0558
73887062|NCT02059278|147308469|EQUIVALENCE|Analysis at 4 pm on Day 42|Mean Difference (Final Values)|0.538||||0.0491|TWO_SIDED|95.0|0.002|1.074|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.074|0.002|0.0491
73887063|NCT02059278|147308469|EQUIVALENCE|Analysis at 8 am on Day 84|Mean Difference (Final Values)|0.808||||0.0025|TWO_SIDED|95.0|0.286|1.329|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.329|0.286|0.0025
73887064|NCT02059278|147308469|EQUIVALENCE|Analysis at 10 am on Day 84|Mean Difference (Final Values)|0.627||||0.0113|TWO_SIDED|95.0|0.143|1.111|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.111|0.143|0.0113
73887065|NCT02059278|147308469|EQUIVALENCE|Analysis at 4 pm on Day 84|Mean Difference (Final Values)|0.456||||0.0649|TWO_SIDED|95.0|-0.063|0.975|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||0.975|-0.063|0.0649
73887066|NCT00541658|147308474|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.233|||||TWO_SIDED|95.0|-0.812|0.345|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.345|-0.812|
73888570|NCT01929317|147309713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.78|||||TWO_SIDED|95.0|-12.06|6.49|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 6."|||6.49|-12.06|
74079665|NCT02213263|147712802|SUPERIORITY||Mean Difference (Final Values)|-2.31|||||TWO_SIDED|95.0|-11.09|6.5||||||Difference in CR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.||6.50|-11.09|
74079666|NCT02213263|147712803|SUPERIORITY||Hazard Ratio (HR)|1.492||||0.185|TWO_SIDED|95.0|0.823|2.704||A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to DOR at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||2.704|0.823|0.185
73887067|NCT00541658|147308474|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.296|||||TWO_SIDED|95.0|-0.869|0.277|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.277|-0.869|
73888571|NCT01929317|147309713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46|||||TWO_SIDED|95.0|-14.06|5.14|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 8."|||5.14|-14.06|
73888572|NCT01929317|147309713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98|||||TWO_SIDED|95.0|-15.92|3.96|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 12."|||3.96|-15.92|
73887068|NCT00541658|147308475|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265||||0.2955|TWO_SIDED|95.0|-0.763|0.232|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant used.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.232|-0.763|0.2955
73887069|NCT00541658|147308476|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.131|||||TWO_SIDED|95.0|-0.674|0.412|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.412|-0.674|
73887070|NCT00541658|147308476|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|0.156|||||TWO_SIDED|95.0|-0.382|0.695|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.695|-0.382|
73888573|NCT01929317|147309714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-1.07|1.21|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 2."|||1.21|-1.07|
73888574|NCT01929317|147309714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-0.75|1.7|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 4."|||1.70|-0.75|
73887071|NCT00541658|147308477|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.258|||||TWO_SIDED|95.0|-0.836|0.321|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.321|-0.836|
73887072|NCT00541658|147308477|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.322|||||TWO_SIDED|95.0|-0.9|0.256|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.256|-0.900|
73887073|NCT00541658|147308478|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.154|||||TWO_SIDED|95.0|-1.903|-0.405|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.405|-1.903|
73887074|NCT00541658|147308478|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.044|||||TWO_SIDED|95.0|-1.789|-0.299|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.299|-1.789|
73887075|NCT00541658|147308479|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.059|||||TWO_SIDED|95.0|-1.762|-0.355|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.355|-1.762|
73887076|NCT00541658|147308479|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.922|||||TWO_SIDED|95.0|-1.62|-0.223|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.223|-1.620|
73887077|NCT00541658|147308480|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0524|TWO_SIDED|95.0|1.0|1.16|||Fisher Exact|||||1.16|1.00|0.0524
73887078|NCT00541658|147308480|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.1207|TWO_SIDED|95.0|0.99|1.15|||Fisher Exact|||||1.15|0.99|0.1207
73887079|NCT00541658|147308481|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.0729|TWO_SIDED|95.0|1.0|1.15|||Fisher Exact|||||1.15|1.00|0.0729
73887080|NCT00541658|147308481|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.06||||0.1639|TWO_SIDED|95.0|0.98|1.14|||Fisher Exact|||||1.14|0.98|0.1639
73888493|NCT05465317|147309644|OTHER||Hazard Ratio (HR)|0.8||||0.08|TWO_SIDED|95.0|0.63|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.63|0.08
73888575|NCT01929317|147309714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.65|1.86|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 6."|||1.86|-0.65|
73888576|NCT01929317|147309714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||||TWO_SIDED|95.0|-0.52|2.22|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 8."|||2.22|-0.52|
73887081|NCT00541658|147308482|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0476|TWO_SIDED|95.0|1.0|1.16|||Fisher Exact|||||1.16|1.00|0.0476
73888577|NCT01929317|147309714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-0.55|2.26|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 12."|||2.26|-0.55|
73887082|NCT00541658|147308482|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.12||||0.0014|TWO_SIDED|95.0|1.04|1.2|||ANOVA|||||1.20|1.04|0.0014
73887083|NCT00541658|147308483|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0547|TWO_SIDED|95.0|1.0|1.16|||ANOVA|||||1.16|1.00|0.0547
73887084|NCT00541658|147308483|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.1||||0.0066|TWO_SIDED|95.0|1.03|1.18|||ANOVA|||||1.18|1.03|0.0066
73888578|NCT01929317|147309715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-0.98|1.36|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 2."|||1.36|-0.98|
73888579|NCT01929317|147309715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|||||TWO_SIDED|95.0|-0.64|1.78|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 4."|||1.78|-0.64|
73887085|NCT00541658|147308484|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.135|||||TWO_SIDED|95.0|-0.504|0.234|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.234|-0.504|
73887086|NCT00541658|147308484|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.072|||||TWO_SIDED|95.0|-0.437|0.294|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.294|-0.437|
73887087|NCT00541658|147308485|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.321|||||TWO_SIDED|95.0|-0.724|0.082|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.082|-0.724|
73887088|NCT00541658|147308485|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||TWO_SIDED|95.0|-0.692|0.112|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.112|-0.692|
73887089|NCT00541658|147308486|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.288|||||TWO_SIDED|95.0|-0.682|0.106|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.106|-0.682|
73887090|NCT00541658|147308486|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||TWO_SIDED|95.0|-0.681|0.101|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.101|-0.681|
73887091|NCT00541658|147308487|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.644|||||TWO_SIDED|95.0|-1.179|-0.11|||ANOVA|||||-0.110|-1.179|
73887092|NCT00541658|147308487|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.587|||||TWO_SIDED|95.0|-1.116|-0.059|||ANOVA|||||-0.059|-1.116|
73887093|NCT00541658|147308488|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.522|||||TWO_SIDED|95.0|-1.03|-0.014|||ANOVA|||||-0.014|-1.030|
73887094|NCT00541658|147308488|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.468|||||TWO_SIDED|95.0|-0.973|0.037|||ANOVA|||||0.037|-0.973|
73887095|NCT00541658|147308489|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||TWO_SIDED|95.0|-0.731|0.201|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.201|-0.731|
73887096|NCT00541658|147308489|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.126|||||TWO_SIDED|95.0|-0.588|0.336|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.336|-0.588|
73887097|NCT00541658|147308490|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.328|||||TWO_SIDED|95.0|-0.811|0.156|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.156|-0.811|
73887098|NCT00541658|147308490|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.563|||||TWO_SIDED|95.0|-1.045|-0.08|||ANOVA|Fixed effects for treatment, pooled center, anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.080|-1.045|
73888494|NCT05465317|147309645|OTHER||Hazard Ratio (HR)|0.68||||0.05|TWO_SIDED|95.0|0.46|1.0|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.00|0.46|0.05
73887099|NCT00541658|147308491|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.327|||||TWO_SIDED|95.0|-0.793|0.138|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.138|-0.793|
73887100|NCT00541658|147308491|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.537|||||TWO_SIDED|95.0|-1.0|-0.074|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.074|-1.000|
73888495|NCT05465317|147309645|OTHER||Hazard Ratio (HR)|0.61||||0.09|TWO_SIDED|95.0|0.35|1.09|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.09|0.35|0.09
73887101|NCT00541658|147308492|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.578|||||TWO_SIDED|95.0|-1.189|0.032|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.032|-1.189|
73887102|NCT00541658|147308492|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.799|||||TWO_SIDED|95.0|-1.403|-0.194|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.194|-1.403|
73887103|NCT00541658|147308493|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.555|||||TWO_SIDED|95.0|-1.128|0.018|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.018|-1.128|
74079667|NCT02213263|147712804|SUPERIORITY||Hazard Ratio (HR)|2.94||||0.319|TWO_SIDED|95.0|0.0||Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to overall survival at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.||||0.000|0.319
74079668|NCT00834275|147712858|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|94.0|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||104|94|
74079669|NCT00834275|147712859|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||105|98.3|
74079670|NCT00834275|147712860|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||104|98.3|
74079671|NCT01030133|147712863|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|0.75||||||0.05
74079672|NCT00835705|147712898|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.03||||||90.0|98.4|107.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.88|98.40|
74079673|NCT00835705|147712899|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.43||||||90.0|96.71|100.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.18|96.71|
74079674|NCT00835705|147712900|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.29||||||90.0|96.58|100.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.03|96.58|
74079675|NCT00835705|147712901|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.16||||||90.0|95.33|111.64|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||111.64|95.33|
74079676|NCT00835705|147712902|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.79||||||90.0|95.75|112.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.50|95.75|
74079677|NCT00835705|147712903|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|104.26||||||90.0|95.76|113.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||113.52|95.76|
74079678|NCT01750294|147712904|SUPERIORITY_OR_OTHER|||||||0.01||||||a = 0.05|Mixed Models Analysis|||||||0.01
74079679|NCT01011413|147712924|NON_INFERIORITY|"Only the primary endpoint is assessed in terms of non-inferiority. All other comparisons are tests for superiority and are considered statistically significant at a two-sided alpha=0.05.~Non-inferiority of EFV 400 mg was defined as the lower 95% confidence interval (CI) of the difference between groups in the proportion of viral load below 200 copies/mL at week 48 lying above -10%."||||||0.05||||||No adjustments were made for multiple comparisons|Pearson's chi-squared|Pearson's chi-squared or Fisher's exact test derived p value was used||Sample size calculation assumes 85% of participants randomised to 600mg EFV arm will have plasma HIV RNA \<200 copies/ml at 48 weeks. Assuming no difference between randomised treatments in proportion with plasma HIV RNA \<200 copies/mL, to have 90% power to demonstrate non-inferiority in the intention to treat (ITT) analysis using a 10% non-inferiority margin will require 286 participants per arm, making a total of 572 participants. Power for modified ITT analysis was 93%.||||0.05
73888580|NCT01929317|147309715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|||||TWO_SIDED|95.0|-0.71|1.84|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 6."|||1.84|-0.71|
73887104|NCT00541658|147308493|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.616|||||TWO_SIDED|95.0|-1.185|-0.046|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.046|-1.185|
73887105|NCT00541658|147308494|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.249|||||TWO_SIDED|95.0|-0.86|0.363|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.363|-0.860|
73887106|NCT00541658|147308494|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||TWO_SIDED|95.0|-0.871|0.342|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.342|-0.871|
73888496|NCT05465317|147309645|OTHER||Hazard Ratio (HR)|0.75||||0.3|TWO_SIDED|95.0|0.43|1.29|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.29|0.43|0.30
73887107|NCT00541658|147308495|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.557|||||TWO_SIDED|95.0|-1.185|0.071|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.071|-1.185|
73887108|NCT00541658|147308495|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.522|||||TWO_SIDED|95.0|-1.149|0.105|||ANOVA||LS Mean Difference is 5 mg daily minus weekly treatment.|||0.105|-1.149|
73887109|NCT00541658|147308496|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.546|||||TWO_SIDED|95.0|-1.17|0.078|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.078|-1.170|
73887110|NCT00541658|147308496|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.579|||||TWO_SIDED|95.0|-1.199|0.042|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.042|-1.199|
73887111|NCT00541658|147308497|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.095|||||TWO_SIDED|95.0|-1.861|-0.329|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.329|-1.861|
73887112|NCT00541658|147308497|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.19|||||TWO_SIDED|95.0|-1.948|-0.432|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.432|-1.948|
73887113|NCT00541658|147308498|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.919|||||TWO_SIDED|95.0|-1.655|-0.184|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.184|-1.655|
73887114|NCT00541658|147308498|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.056|||||TWO_SIDED|95.0|-1.787|-0.326|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.326|-1.787|
73887115|NCT00541658|147308499|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.771|||||TWO_SIDED|95.0|-0.885|8.427|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.427|-0.885|
73887116|NCT00541658|147308499|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.826|||||TWO_SIDED|95.0|-1.819|7.471|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||7.471|-1.819|
73888581|NCT01929317|147309715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||||TWO_SIDED|95.0|-0.47|2.39|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 8."|||2.39|-0.47|
73887117|NCT00541658|147308500|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.63|||||TWO_SIDED|95.0|-2.171|7.431|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||7.431|-2.171|
73887118|NCT00541658|147308500|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.617|||||TWO_SIDED|95.0|-0.152|9.386|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.386|-0.152|
73887119|NCT00541658|147308501|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.04|||||TWO_SIDED|95.0|0.091|9.989|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.989|0.091|
73887120|NCT00541658|147308501|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.64|||||TWO_SIDED|95.0|-0.293|9.574|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.574|-0.293|
73887121|NCT00541658|147308502|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.372|||||TWO_SIDED|95.0|1.329|11.414|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||11.414|1.329|
73887122|NCT00541658|147308502|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.403|||||TWO_SIDED|95.0|-0.619|9.425|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.425|-0.619|
73887123|NCT00541658|147308503|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.739|||||TWO_SIDED|95.0|-0.793|10.271|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.271|-0.793|
73887124|NCT00541658|147308503|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.999|||||TWO_SIDED|95.0|-1.518|9.515|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.515|-1.518|
73888497|NCT05465317|147309646|OTHER||Hazard Ratio (HR)|0.73||||0.11|TWO_SIDED|95.0|0.49|1.08|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.08|0.49|0.11
73887125|NCT00541658|147308504|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.817|||||TWO_SIDED|95.0|-0.693|10.327|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.327|-0.693|
73887126|NCT00541658|147308504|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.192|||||TWO_SIDED|95.0|-2.295|8.68|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.680|-2.295|
73887127|NCT00541658|147308505|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.45|||||TWO_SIDED|95.0|-0.26|9.16|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.160|-0.260|
73887128|NCT00541658|147308505|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.723|||||TWO_SIDED|95.0|-0.975|8.421|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.421|-0.975|
73887129|NCT00541658|147308506|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.798|||||TWO_SIDED|95.0|-0.195|9.79|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.790|-0.195|
73887130|NCT00541658|147308506|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.972|||||TWO_SIDED|95.0|0.02|9.924|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.924|0.020|
73887131|NCT00541658|147308507|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.775|||||TWO_SIDED|95.0|-0.514|10.065|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.065|-0.514|
73887132|NCT00541658|147308507|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.638||||||95.0|0.356|10.92|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.920|0.356|
73887133|NCT00541658|147308508|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.552|||||TWO_SIDED|95.0|1.162|11.942|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||11.942|1.162|
73887134|NCT00541658|147308508|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.531|||||TWO_SIDED|95.0|0.164|10.897|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.897|0.164|
73887135|NCT00541658|147308509|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.83|||||TWO_SIDED|95.0|1.175|14.485|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||14.485|1.175|
73887136|NCT00541658|147308509|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|8.383|||||TWO_SIDED|95.0|1.757|15.01|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||15.010|1.757|
73887137|NCT00541658|147308510|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.802|||||TWO_SIDED|95.0|1.385|14.22|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||14.220|1.385|
73887138|NCT00541658|147308510|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.301|||||TWO_SIDED|95.0|0.911|13.69|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||13.690|0.911|
73888498|NCT05465317|147309646|OTHER||Hazard Ratio (HR)|0.63||||0.12|TWO_SIDED|95.0|0.35|1.12|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.12|0.35|0.12
73887139|NCT00541658|147308511|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.755|||||TWO_SIDED|95.0|-1.145|4.655|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.655|-1.145|
73887140|NCT00541658|147308511|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.805|||||TWO_SIDED|95.0|-1.087|4.698|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.698|-1.087|
73887141|NCT00541658|147308512|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.407|||||TWO_SIDED|95.0|-0.502|5.316|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.316|-0.502|
73887142|NCT00541658|147308512|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.309|||||TWO_SIDED|95.0|-1.576|4.194|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.194|-1.576|
73888499|NCT05465317|147309646|OTHER||Hazard Ratio (HR)|0.84||||0.52|TWO_SIDED|95.0|0.5|1.42|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.42|0.50|0.52
73888582|NCT01929317|147309715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||||TWO_SIDED|95.0|-0.63|2.33|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 12."|||2.33|-0.63|
73887143|NCT00541658|147308513|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.555|||||TWO_SIDED|95.0|-1.617|4.727|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.727|-1.617|
73887144|NCT00541658|147308513|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.612|||||TWO_SIDED|95.0|-1.556|4.779|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.779|-1.556|
73887145|NCT00541658|147308514|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.434|||||TWO_SIDED|95.0|-1.652|4.521|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.521|-1.652|
73887146|NCT00541658|147308514|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.462|||||TWO_SIDED|95.0|-1.611|4.535|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.535|-1.611|
73888583|NCT02864394|147309778|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1276|TWO_SIDED|95.0|0.61|1.14|||Log Rank|||Treatment comparison (Hazard Ratio, HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate. One-sided p-value was based on log-rank test.||1.14|0.61|0.1276
73887147|NCT00541658|147308515|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.749|||||TWO_SIDED|95.0|-0.938|6.436|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||6.436|-0.938|
73887148|NCT00541658|147308515|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.416|||||TWO_SIDED|95.0|-0.255|7.087|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus daily treatment.|||7.087|-0.255|
73887149|NCT00541658|147308516|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.197|||||TWO_SIDED|95.0|-1.318|5.711|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.711|-1.318|
73887150|NCT00541658|147308516|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.251|||||TWO_SIDED|95.0|-1.248|5.751|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.751|-1.248|
73887151|NCT00541658|147308517|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|TWO_SIDED|95.0|0.14|7.05|||Fisher Exact|||||7.05|0.14|1.0000
73887152|NCT00541658|147308517|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|TWO_SIDED|95.0|0.25|8.9|||Fisher Exact|||||8.90|0.25|1.0000
73887153|NCT00541658|147308518|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|TWO_SIDED|95.0|0.15|7.29|||Fisher Exact|||||7.29|0.15|1.0000
73887154|NCT00541658|147308518|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|TWO_SIDED|95.0|0.25|8.87|||Fisher Exact|||||8.87|0.25|1.0000
73888500|NCT05465317|147309648|OTHER||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.72|0.97|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.97|0.72|0.02
73887155|NCT00541658|147308519|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|TWO_SIDED|95.0|0.08|2.14|||Fisher Exact|||||2.14|0.08|0.4505
73887156|NCT00541658|147308519|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|TWO_SIDED|95.0|0.22|3.03|||Fisher Exact|||||3.03|0.22|1.0000
73887157|NCT00541658|147308520|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|TWO_SIDED|95.0|0.08|2.11|||Fisher Exact|||||2.11|0.08|0.4505
73887158|NCT00541658|147308520|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|TWO_SIDED|95.0|0.37|3.9|||Fisher Exact|||||3.90|0.37|0.7719
73887159|NCT00541658|147308521|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|TWO_SIDED|95.0|0.14|7.05|||Fisher Exact|||||7.05|0.14|1.0000
73887160|NCT00541658|147308521|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|TWO_SIDED|95.0|0.25|8.9|||Fisher Exact|||||8.90|0.25|1.0000
73887161|NCT00541658|147308522|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|TWO_SIDED|95.0|0.15|7.29|||Fisher Exact|||||7.29|0.15|1.0000
73887162|NCT00541658|147308522|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|TWO_SIDED|95.0|0.25|8.87|||Fisher Exact|||||8.87|0.25|1.0000
73887163|NCT00541658|147308523|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|TWO_SIDED|95.0|0.08|2.14|||Fisher Exact|||||2.14|0.08|0.4505
73887164|NCT00541658|147308523|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|TWO_SIDED|95.0|0.22|3.03|||Fisher Exact|||||3.03|0.22|1.0000
73887165|NCT00541658|147308524|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|TWO_SIDED|95.0|0.08|2.11|||Fisher Exact|||||2.11|0.08|0.4505
73887166|NCT00541658|147308524|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|TWO_SIDED|95.0|0.37|3.9|||Fisher Exact|||||3.90|0.37|0.7719
73887167|NCT02344108|147308549|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73887168|NCT02344108|147308550|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73887169|NCT02344108|147308551|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
73887170|NCT02344108|147308552|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
73887171|NCT02344108|147308553|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
73887172|NCT02344108|147308554|SUPERIORITY|||||||0.764|||||||t-test, 2 sided|||||||0.764
73887173|NCT02344108|147308555|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73887174|NCT02344108|147308556|SUPERIORITY|||||||0.467|||||||t-test, 2 sided|||||||0.467
73887175|NCT02344108|147308557|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||0.745
73887176|NCT02344108|147308558|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||||||0.106
73887177|NCT02344108|147308559|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73887178|NCT02344108|147308560|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73887179|NCT02344108|147308561|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73887180|NCT00905164|147308625|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|99.5|||||TWO_SIDED|90.0|94.27|105.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125|||105.03|94.27|
73887181|NCT00905164|147308626|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|100.13||||||90.0|97.6|102.72|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.72|97.60|
73887182|NCT00905164|147308627|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|101.53||||||90.0|99.01|104.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.12|99.01|
74079680|NCT01011413|147712924|NON_INFERIORITY|Non-inferiority will be defined as the lower 95% confidence limit of the difference in percentages of patients with undetectable viral load lying above -10% (i.e. a non-inferiority margin of 10%).||||||0.05||||||No adjustment for multiple comparisons|Chi-squared|||To ensure the per protocol (PP) analysis has 90% power to demonstrate non-inferiority, the sample size was inflated for patients who switch treatment for toxicity. This is estimated to be no more than 10% randomised patients. To ensure 90% power to demonstrate non-inferiority in the ITT and PP analyses, a total of 630 (315 per arm) patients will be randomised giving 93% power for the ITT analysis. Null hypothesis: no statistically significant difference between the 600mg and 400mg EFV regimens.||||0.05
74079681|NCT01011413|147712925|SUPERIORITY_OR_OTHER_LEGACY||difference between proportions|0.05||||0.05|TWO_SIDED|95.0||||P-value not adjusted for multiple comparisons|Chi-squared|||||||0.05
74079682|NCT03206749|147712937|SUPERIORITY||Least Squares (LS) Mean Difference|29.5|||<|0.0001|TWO_SIDED|95.0|16.61|42.4|||ANCOVA|||||42.40|16.61|<0.0001
74079683|NCT03206749|147712938|SUPERIORITY||LS Mean Difference|28.53|||<|0.0001|TWO_SIDED|95.0|16.18|40.88|||ANCOVA|||||40.88|16.18|<0.0001
74079684|NCT03206749|147712939|SUPERIORITY||LS Mean Difference|62.79|||<|0.0001|TWO_SIDED|95.0|36.3|89.27|||ANCOVA|||||89.27|36.30|<0.0001
74079685|NCT03206749|147712940|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.0469|TWO_SIDED|95.0|1.01|2.16|||Regression, Cox|||||2.16|1.01|0.0469
74079686|NCT03206749|147712941|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.3294|TWO_SIDED|95.0|0.79|2.0|||Regression, Cox|||||2.00|0.79|0.3294
74079687|NCT03206749|147712942|SUPERIORITY|||||||0.2341|||||||Regression, Cox|||||||0.2341
74079688|NCT03206749|147712943|SUPERIORITY|||||||0.3358||||||0 - 24 hours|Cochran-Mantel-Haenszel|||||||0.3358
74079689|NCT03206749|147712943|SUPERIORITY|||||||0.0849||||||Greater than (\>) 24 - 48 hours|Cochran-Mantel-Haenszel|||||||0.0849
74079690|NCT03206749|147712944|SUPERIORITY|||||||0.0004||||||0 - 24 hours|Wilcoxon rank-sum test|||||||0.0004
74079691|NCT03206749|147712944|SUPERIORITY|||||||0.0035||||||\>24 - 48 hours|Wilcoxon rank-sum test|||||||0.0035
74079692|NCT03779334|147712959|SUPERIORITY||||||<|0.0001|||||||Exact Binomial Test|Performance Criterion = 5%||||||<0.0001
74079693|NCT01175135|147712987|OTHER||Least Squares (LS) Mean Difference|-2.21|STANDARD_ERROR_OF_MEAN|2.683||0.2053|TWO_SIDED|80.0|-5.66|1.24||Reported p-value was 1-sided.|Mixed Models Analysis|||Mixed effect repeated measures (MMRM) model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||1.24|-5.66|0.2053
74079694|NCT01175135|147712987|OTHER||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|2.698||0.4024|TWO_SIDED|80.0|-4.14|2.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||2.80|-4.14|0.4024
74079695|NCT01175135|147712987|OTHER||LS Mean Difference|-8.24|STANDARD_ERROR_OF_MEAN|3.453||0.009|TWO_SIDED|80.0|-12.68|-3.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-3.80|-12.68|0.0090
74079696|NCT01175135|147712988|OTHER||Difference in Proportion|-0.03|||||TWO_SIDED|80.0|-0.07|0.01|||||The adjusted 80% Confidence Interval (CI) equals 88.6% CI, adjusted due to 1 interim look.|||0.01|-0.07|
74079697|NCT01175135|147712988|OTHER||Difference in Proportion|0.04|||||TWO_SIDED|80.0|-0.02|0.1|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.|||0.10|-0.02|
74079698|NCT01175135|147712988|OTHER||Difference in Proportion|-0.04|||||TWO_SIDED|80.0|-0.08|0.0|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.|||-0.00|-0.08|
74079699|NCT01175135|147712989|OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.845||0.3144|TWO_SIDED|80.0|-1.5|0.68||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.68|-1.50|0.3144
74079700|NCT01175135|147712989|OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.854||0.57|TWO_SIDED|80.0|-0.95|1.25||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||1.25|-0.95|0.5700
74079701|NCT01175135|147712989|OTHER||LS Mean Difference|-2.99|STANDARD_ERROR_OF_MEAN|1.093||0.0034|TWO_SIDED|80.0|-4.4|-1.59||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-1.59|-4.40|0.0034
74079702|NCT01175135|147712989|OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.73||0.0942|TWO_SIDED|80.0|-1.9|-0.02||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-0.02|-1.90|0.0942
74079703|NCT01175135|147712989|OTHER||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.735||0.203|TWO_SIDED|80.0|-1.56|0.33||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.33|-1.56|0.2030
74079704|NCT01175135|147712989|OTHER||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.944||0.0907|TWO_SIDED|80.0|-2.48|-0.05||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-0.05|-2.48|0.0907
74079705|NCT01175135|147712989|OTHER||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|1.33||0.2904|TWO_SIDED|80.0|-2.45|0.97||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.97|-2.45|0.2904
73887183|NCT05366738|147308634|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|103.36|||||TWO_SIDED|90.0|97.64|109.41||||||||109.41|97.64|
73887184|NCT05366738|147308634|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|97.83|||||TWO_SIDED|90.0|92.42|103.56||||||||103.56|92.42|
73887185|NCT05366738|147308635|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|102.56|||||TWO_SIDED|90.0|97.25|108.15||||||||108.15|97.25|
73887186|NCT05366738|147308635|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|97.61|||||TWO_SIDED|90.0|92.55|102.93||||||||102.93|92.55|
73887187|NCT05366738|147308636|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|103.96|||||TWO_SIDED|90.0|96.49|112.0||||||||112.00|96.49|
73887188|NCT05366738|147308636|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|100.6|||||TWO_SIDED|90.0|93.38|108.39||||||||108.39|93.38|
73887189|NCT02230995|147308642|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.22|STANDARD_DEVIATION|5.0|<|1e-05|TWO_SIDED|90.0|96.11|100.39|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||100.39|96.11|<0.00001
73887190|NCT02230995|147308643|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|102.14|STANDARD_DEVIATION|7.9|<|1e-05|TWO_SIDED|90.0|98.65|105.76|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||105.76|98.65|<0.00001
73887191|NCT02230995|147308644|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.7|STANDARD_DEVIATION|12.3|<|1e-05|TWO_SIDED|90.0|93.51|104.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||104.17|93.51|<0.00001
73887192|NCT02230995|147308645|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|105.69|STANDARD_DEVIATION|10.9|<|1e-05|TWO_SIDED|90.0|100.78|110.84|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||110.84|100.78|<0.00001
73887193|NCT02230995|147308646|SUPERIORITY_OR_OTHER||Adjusted gMean ratio|98.32|STANDARD_DEVIATION|5.1|||TWO_SIDED|90.0|96.16|100.53|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by ratios of adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||100.53|96.16|
73887194|NCT02230995|147308647|SUPERIORITY_OR_OTHER||Adjusted gMean ratio|104.66|STANDARD_DEVIATION|7.3|||TWO_SIDED|90.0|101.36|108.07|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||108.07|101.36|
73888501|NCT05465317|147309648|OTHER||Hazard Ratio (HR)|0.82||||0.12|TWO_SIDED|95.0|0.65|1.05|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.05|0.65|0.12
73887195|NCT00906204|147308648|NON_INFERIORITY_OR_EQUIVALENCE|A one-sided alpha = 0.05, 85% power, an event rate of 0.70, equivalence margin of 0.20. Sample size = 75 patients per dose group, a total of 150 patients. Data analyzed will be counts of patients in each group who experience one or more component events of the primary endpoint during postoperative days one through seven. The DSMB requested an interim analysis after 80 patients and recommended ending the trial because the primary endpoint had been robustly reached.||||||0.64|TWO_SIDED||||||Fisher Exact|||The analysis compares the rates at which patients in each of the two groups cumulatively exceed the five composite endpoint thresholds. There are five safety outcomes monitored during the first seven post-transplantation days. The rates of observed vs. possible safety outcomes are compared.||||0.64
73887196|NCT00906204|147308649|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Log Rank|||||||0.35
73887197|NCT00906204|147308650|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Log Rank|||||||0.47
73887198|NCT00906204|147308651|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Log Rank|||||||0.78
73887199|NCT00906204|147308652|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Fisher Exact|||||||0.72
73887200|NCT00906204|147308653|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
73887201|NCT01347112|147308688|SUPERIORITY_OR_OTHER|||||||0.034||||||1 tailed fisher's exact test|Fisher Exact|1 tailed||||||0.034
73887202|NCT01347112|147308689|SUPERIORITY_OR_OTHER|||||||0.044||||||1 tailed fisher's exact|Fisher Exact|1 tailed||||||0.044
73887203|NCT01347112|147308690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|90.0|-4.7|2.1|||||data were analyzed using analysis of covariance with treatment as the independent variable and the baseline value included as the co-variate|||2.1|-4.7|
73887204|NCT02141295|147308735|OTHER||Hazard Ratio (HR)|0.91|||=|0.6753|TWO_SIDED|95.0|0.6|1.39||log-rank|Regression, Cox|||Kaplan-Meier methods were used to estimate median PFS for each treatment arm and the 95% CIs for median PFS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \>1) and country/region (USA vs rest of the world).||1.39|0.60|= 0.6753
73887205|NCT02141295|147308738|OTHER||Hazard Ratio (HR)|0.85|||=|0.574|TWO_SIDED|95.0|0.49|1.49|||Log Rank|||Kaplan-Meier methods were used to estimate median OS for each treatment arm and the 95% CIs for median OS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \>1) and country/region (USA vs rest of the world).||1.49|0.49|= 0.5740
73887206|NCT00071890|147308760|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Chi-squared|||||||0.025
73887207|NCT00071890|147308761|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Biphasic decline of CD4 after week 24 : first slope before W32 and weaker decline until W168.Slopes significantly different (all p values ≤0.0001) between the 2 groups, more pronounced in the IL-2 groups|Wilcoxon (Mann-Whitney)|||||||0.069
73887208|NCT01389596|147308767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.092||0.2577|TWO_SIDED|95.0|-0.29|0.08|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.||0.08|-0.29|0.2577
73887209|NCT01389596|147308767|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.094||0.0185|TWO_SIDED|95.0|-0.41|-0.04|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.||-0.04|-0.41|0.0185
73887210|NCT01389596|147308768|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.036||||0.8024|TWO_SIDED|95.0|0.528|2.03|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.||2.030|0.528|0.8024
73887211|NCT01389596|147308768|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.636||||0.0092|TWO_SIDED|95.0|0.851|3.147|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.||3.147|0.851|0.0092
73887212|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||MI at 0-6 Months||||>0.999
73887213|NCT02144610|147308790|SUPERIORITY_OR_OTHER|||||||0.4889|||||||Fisher Exact|||MI at 0-12 Months||||0.4889
73887214|NCT02144610|147308790|SUPERIORITY_OR_OTHER|||||||0.4889|||||||Fisher Exact|||MI at 0-18 Months||||0.4889
73887215|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-6 Months||||>0.999
73887216|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-12 Months||||>0.999
73887217|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-18 Months||||>0.999
73887218|NCT02144610|147308790|SUPERIORITY_OR_OTHER|||||||0.7381|||||||Fisher Exact|||Major amputation at 0-6 Months||||0.7381
73887219|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-12 Months||||>0.999
73887220|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-18 Months||||>0.999
73887221|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Revascularization at 0-6 Months||||>0.999
73887222|NCT02144610|147308790|SUPERIORITY_OR_OTHER|||||||0.4591|||||||Fisher Exact|||Revascularization at 0-12 Months||||0.4591
73887223|NCT02144610|147308790|SUPERIORITY_OR_OTHER|||||||0.4591|||||||Fisher Exact|||Revascularization at 0-18 Months||||0.4591
73887224|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-6 Months||||>0.999
73887225|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-12 Months||||>0.999
73887226|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-18 Months||||>0.999
73887227|NCT02144610|147308790|SUPERIORITY_OR_OTHER|||||||0.5136|||||||Fisher Exact|||0-6 Months (Major Amputation or Death)||||0.5136
73887228|NCT02144610|147308790|SUPERIORITY_OR_OTHER|||||||0.7575|||||||Fisher Exact|||0-12 Months (Major Amputation or Death)||||0.7575
73887229|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Death)||||>0.999
73887230|NCT02144610|147308790|SUPERIORITY_OR_OTHER|||||||0.7575|||||||Fisher Exact|||0-6 Months (Major Amputation or Revascularization)||||0.7575
73887231|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-12 Months (Major Amputation or Revascularization)||||>0.999
73887232|NCT02144610|147308790|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Revascularization)||||>0.999
73887233|NCT02144610|147308791|SUPERIORITY_OR_OTHER|||||||0.514|||||||ANCOVA|||Change from Baseline at Month 3||||0.514
73887234|NCT02144610|147308791|SUPERIORITY_OR_OTHER|||||||0.445|||||||ANCOVA|||Change from Baseline at Month 6||||0.445
73887235|NCT02144610|147308791|SUPERIORITY_OR_OTHER|||||||0.863|||||||ANCOVA|||Change from Baseline at Month 9||||0.863
73887236|NCT02144610|147308791|SUPERIORITY_OR_OTHER|||||||0.111|||||||ANCOVA|||Change from Baseline at Month 12||||0.111
73887237|NCT02144610|147308791|SUPERIORITY_OR_OTHER|||||||0.153|||||||ANCOVA|||Change from Baseline at Month 15||||0.153
73887238|NCT02144610|147308791|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||Change from Baseline at last observation carried forward (LOCF)||||0.002
73887239|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.733|||||||ANCOVA|||Change from baseline at Month 3 (right brachial)||||0.733
73887240|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.808|||||||ANCOVA|||Change from baseline at Month 6 (right brachial)||||0.808
73887241|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.487|||||||ANCOVA|||Change from baseline at Month 9 (right brachial)||||0.487
73887242|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.216|||||||ANCOVA|||Change from baseline at Month 12 (right brachial)||||0.216
73887243|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.896|||||||ANCOVA|||Change from baseline at Month 15 (right brachial)||||0.896
73887244|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.167|||||||ANCOVA|||Change from baseline at last observation carried forward (LOCF) (right brachial)||||0.167
73887245|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.378|||||||ANCOVA|||Change from baseline at Month 3 (left brachial)||||0.378
73887246|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANCOVA|||Change from baseline at Month 6 (left brachial)||||0.390
73887247|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.521|||||||ANCOVA|||Change from baseline at Month 9 (left brachial)||||0.521
73887248|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANCOVA|||Change from baseline at Month 12 (left brachial)||||0.044
73887249|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.423|||||||ANCOVA|||Change from baseline at Month 15 (left brachial)||||0.423
73887250|NCT02144610|147308794|SUPERIORITY_OR_OTHER|||||||0.989|||||||ANCOVA|||Change from baseline at LOCF (left brachial)||||0.989
73887251|NCT02144610|147308795|SUPERIORITY_OR_OTHER|||||||0.803|||||||ANCOVA|||Change from Baseline at Month 3 (Dorsalis Pedis)||||0.803
73887252|NCT02144610|147308795|SUPERIORITY_OR_OTHER|||||||0.668|||||||ANCOVA|||Change from Baseline at Month 6 (Dorsalis Pedis)||||0.668
73887253|NCT02144610|147308795|SUPERIORITY_OR_OTHER|||||||0.789|||||||ANCOVA|||Change from Baseline at Month 9 (Dorsalis Pedis)||||0.789
73887254|NCT02144610|147308795|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANCOVA|||Change from Baseline at Month 12 (Dorsalis Pedis)||||0.280
73887255|NCT02144610|147308795|SUPERIORITY_OR_OTHER|||||||0.324|||||||ANCOVA|||Change from Baseline at LOCF (Dorsalis Pedis)||||0.324
73887256|NCT02144610|147308795|SUPERIORITY_OR_OTHER|||||||0.759|||||||ANCOVA|||Change from Baseline at Month 3 (Posterior Tibial)||||0.759
73887257|NCT02144610|147308795|SUPERIORITY_OR_OTHER|||||||0.414|||||||ANCOVA|||Change from Baseline at Month 6 (Posterior Tibial)||||0.414
73887258|NCT02144610|147308795|SUPERIORITY_OR_OTHER|||||||0.886|||||||ANCOVA|||Change from Baseline at Month 9 (Posterior Tibial)||||0.886
73887259|NCT02144610|147308795|SUPERIORITY_OR_OTHER|||||||0.114|||||||ANCOVA|||Change from Baseline at Month 12 (Posterior Tibial)||||0.114
73887260|NCT02144610|147308795|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANCOVA|||Change from Baseline at LOCF (Posterior Tibial)||||0.051
73887261|NCT02144610|147308796|SUPERIORITY_OR_OTHER|||||||0.211|||||||ANCOVA|||Change from Baseline at Month 3||||0.211
73887262|NCT02144610|147308796|SUPERIORITY_OR_OTHER|||||||0.036|||||||ANCOVA|||Change from Baseline at Month 6||||0.036
73887263|NCT02144610|147308796|SUPERIORITY_OR_OTHER|||||||0.725|||||||ANCOVA|||Change from Baseline at Month 9||||0.725
73887264|NCT02144610|147308796|SUPERIORITY_OR_OTHER|||||||0.468|||||||ANCOVA|||Change from Baseline at Month 12||||0.468
73887265|NCT02144610|147308796|SUPERIORITY_OR_OTHER|||||||0.854|||||||ANCOVA|||Change from Baseline at Month 15||||0.854
73887266|NCT02144610|147308796|SUPERIORITY_OR_OTHER|||||||0.233|||||||ANCOVA|||Change from Baseline at LOCF||||0.233
74079706|NCT01175135|147712989|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.339||0.471|TWO_SIDED|80.0|-1.82|1.62||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||1.62|-1.82|0.4710
74079707|NCT01175135|147712989|OTHER||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|1.718||0.0172|TWO_SIDED|80.0|-5.86|-1.45||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-1.45|-5.86|0.0172
74079708|NCT01175135|147712990|OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.154||0.197|TWO_SIDED|80.0|-0.33|0.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.07|-0.33|0.1970
74079709|NCT01175135|147712990|OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.154||0.3835|TWO_SIDED|80.0|-0.24|0.15||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.15|-0.24|0.3835
73887267|NCT02144610|147308797|SUPERIORITY_OR_OTHER|||||||0.268|||||||ANCOVA|||Change from Baseline at Month 3||||0.268
73887268|NCT02144610|147308797|SUPERIORITY_OR_OTHER|||||||0.32|||||||ANCOVA|||Change from Baseline at Month 6||||0.320
73887269|NCT02144610|147308797|SUPERIORITY_OR_OTHER|||||||0.315|||||||ANCOVA|||Change from Baseline at Month 9||||0.315
73887270|NCT02144610|147308797|SUPERIORITY_OR_OTHER|||||||0.327|||||||ANCOVA|||Change from Baseline at Month 12||||0.327
73887271|NCT02144610|147308797|SUPERIORITY_OR_OTHER|||||||0.643|||||||ANCOVA|||Change from Baseline at Month 15||||0.643
74079710|NCT01175135|147712990|OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.199||0.0395|TWO_SIDED|80.0|-0.61|-0.1||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.10|-0.61|0.0395
74079711|NCT01175135|147712991|OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.863||0.1999|TWO_SIDED|80.0|-1.84|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.84|0.1999
74079712|NCT01175135|147712991|OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.87||0.3399|TWO_SIDED|80.0|-1.48|0.76||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.76|-1.48|0.3399
74079713|NCT01175135|147712991|OTHER||LS Mean Difference|-2.62|STANDARD_ERROR_OF_MEAN|1.117||0.01|TWO_SIDED|80.0|-4.06|-1.18||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-1.18|-4.06|0.0100
74079714|NCT01175135|147712991|OTHER||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.778||0.1625|TWO_SIDED|80.0|-1.77|0.23||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.23|-1.77|0.1625
74079715|NCT01175135|147712991|OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.783||0.2354|TWO_SIDED|80.0|-1.57|0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.44|-1.57|0.2354
74079716|NCT01175135|147712991|OTHER||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.002||0.2161|TWO_SIDED|80.0|-2.08|0.5||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.50|-2.08|0.2161
74079717|NCT01175135|147712991|OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.627||0.248|TWO_SIDED|80.0|-1.23|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.23|0.2480
74079718|NCT01175135|147712991|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.632||0.4345|TWO_SIDED|80.0|-0.92|0.71||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.71|-0.92|0.4345
74079719|NCT01175135|147712991|OTHER||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.813||0.0346|TWO_SIDED|80.0|-2.53|-0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.44|-2.53|0.0346
74079720|NCT01175135|147712991|OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.495||0.4685|TWO_SIDED|80.0|-0.68|0.6||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.60|-0.68|0.4685
74079721|NCT01175135|147712991|OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.499||0.6214|TWO_SIDED|80.0|-0.49|0.8||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.80|-0.49|0.6214
74079722|NCT01175135|147712991|OTHER||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.641||0.0052|TWO_SIDED|80.0|-2.48|-0.84||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.84|-2.48|0.0052
74079723|NCT01175135|147712991|OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.523||0.5894|TWO_SIDED|80.0|-0.55|0.79||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.79|-0.55|0.5894
74079724|NCT01175135|147712991|OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|0.526||0.8155|TWO_SIDED|80.0|-0.2|1.15||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||1.15|-0.20|0.8155
74079725|NCT01175135|147712991|OTHER||LS Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.677||0.0069|TWO_SIDED|80.0|-2.55|-0.81||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.81|-2.55|0.0069
74079726|NCT01175135|147712992|OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.559||0.2727|TWO_SIDED|80.0|-1.06|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.06|0.2727
74079727|NCT01175135|147712992|OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.562||0.4747|TWO_SIDED|80.0|-0.76|0.69||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.69|-0.76|0.4747
74079728|NCT01175135|147712992|OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.723||0.0031|TWO_SIDED|80.0|-2.93|-1.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-1.07|-2.93|0.0031
74079729|NCT01175135|147712993|OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.196||0.3598|TWO_SIDED|80.0|-0.32|0.18||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.18|-0.32|0.3598
74079730|NCT01175135|147712993|OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.198||0.7275|TWO_SIDED|80.0|-0.13|0.37||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.37|-0.13|0.7275
74079731|NCT01175135|147712993|OTHER||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.255||0.0019|TWO_SIDED|80.0|-1.07|-0.42||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.42|-1.07|0.0019
74079732|NCT01175135|147712994|OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|1.478||0.5429|TWO_SIDED|80.0|-2.06|1.74||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||1.74|-2.06|0.5429
73887272|NCT02144610|147308797|SUPERIORITY_OR_OTHER|||||||0.74|||||||ANCOVA|||Change from Baseline at LOCF||||0.740
73887273|NCT02144610|147308798|SUPERIORITY_OR_OTHER|||||||0.147|||||||ANCOVA|||Change from Baseline at Month 3||||0.147
73887274|NCT02144610|147308798|SUPERIORITY_OR_OTHER|||||||0.032|||||||ANCOVA|||Change from Baseline at Month 6||||0.032
73887275|NCT02144610|147308798|SUPERIORITY_OR_OTHER|||||||0.709|||||||ANCOVA|||Change from Baseline at Month 9||||0.709
73887276|NCT02144610|147308798|SUPERIORITY_OR_OTHER|||||||0.771|||||||ANCOVA|||Change from Baseline at Month 12||||0.771
73887277|NCT02144610|147308798|SUPERIORITY_OR_OTHER|||||||0.83|||||||ANCOVA|||Change from Baseline at Month 15||||0.830
73887278|NCT02144610|147308798|SUPERIORITY_OR_OTHER|||||||0.033|||||||ANCOVA|||Change from Baseline at LOCF||||0.033
73887279|NCT02144610|147308799|SUPERIORITY_OR_OTHER|||||||0.105|||||||ANCOVA|||Pain (LOCF)||||0.105
73887280|NCT02144610|147308799|SUPERIORITY_OR_OTHER|||||||0.557|||||||ANCOVA|||Symptom (LOCF)||||0.557
73887281|NCT02144610|147308799|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|||Activities (LOCF)||||0.940
73887282|NCT02144610|147308799|SUPERIORITY_OR_OTHER|||||||0.905|||||||ANCOVA|||Social (LOCF)||||0.905
73887283|NCT02144610|147308799|SUPERIORITY_OR_OTHER|||||||0.782|||||||ANCOVA|||Emotional Functioning (LOCF)||||0.782
73887284|NCT02144610|147308799|SUPERIORITY_OR_OTHER|||||||0.802|||||||ANCOVA|||Composite Overall (LOCF)||||0.802
73887285|NCT02144610|147308800|SUPERIORITY_OR_OTHER|||||||0.941|||||||ANCOVA|||Change from Baseline at Month 3||||0.941
73887286|NCT02144610|147308800|SUPERIORITY_OR_OTHER|||||||0.584|||||||ANCOVA|||Change from Baseline at Month 6||||0.584
73887287|NCT02144610|147308800|SUPERIORITY_OR_OTHER|||||||0.1|||||||ANCOVA|||Change from Baseline at Month 9||||0.100
73887288|NCT02144610|147308800|SUPERIORITY_OR_OTHER|||||||0.916|||||||ANCOVA|||Change from Baseline at Month 12||||0.916
73887289|NCT02144610|147308800|SUPERIORITY_OR_OTHER|||||||0.486|||||||ANCOVA|||Change from Baseline at Month 15||||0.486
73887290|NCT02144610|147308800|SUPERIORITY_OR_OTHER|||||||0.835|||||||ANCOVA|||Change from Baseline at LOCF||||0.835
73887291|NCT01054885|147308802|SUPERIORITY_OR_OTHER||Least squares mean difference|0.046||||0.085|TWO_SIDED|95.0|-0.006|0.098|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.098|-0.006|0.085
74079733|NCT01175135|147712994|OTHER||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|1.492||0.4354|TWO_SIDED|80.0|-1.68|2.16||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||2.16|-1.68|0.4354
73887292|NCT01054885|147308802|SUPERIORITY_OR_OTHER||Least squares mean difference|0.041||||0.123|TWO_SIDED|95.0|-0.011|0.093|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.093|-0.011|0.123
73887293|NCT01054885|147308802|SUPERIORITY_OR_OTHER||Least squares mean difference|0.185|||<|0.001|TWO_SIDED|95.0|0.133|0.237|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.237|0.133|<0.001
73887294|NCT01054885|147308802|SUPERIORITY_OR_OTHER||Least squares mean difference|0.214|||<|0.001|TWO_SIDED|95.0|0.161|0.266||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.266|0.161|<0.001
73887295|NCT01054885|147308802|SUPERIORITY_OR_OTHER||Least squares mean difference|0.209|||<|0.001|TWO_SIDED|95.0|0.157|0.261|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.261|0.157|<0.001
73887296|NCT01054885|147308802|SUPERIORITY_OR_OTHER||Least squares mean difference|0.168|||<|0.001|TWO_SIDED|95.0|0.116|0.22||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.220|0.116|<0.001
73887297|NCT01054885|147308802|SUPERIORITY_OR_OTHER||Least squares mean difference|0.168|||<|0.001|TWO_SIDED|95.0|0.117|0.219|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.219|0.117|<0.001
73887298|NCT01054885|147308802|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.274|TWO_SIDED|95.0|-0.023|0.081|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.081|-0.023|0.274
73887299|NCT01054885|147308802|SUPERIORITY_OR_OTHER||Least squares mean difference|0.024||||0.357|TWO_SIDED|95.0|-0.027|0.075|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.075|-0.027|0.357
73887300|NCT01054885|147308803|SUPERIORITY_OR_OTHER||Least squares mean difference|0.044||||0.095|TWO_SIDED|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.097|-0.008|0.095
73887301|NCT01054885|147308803|SUPERIORITY_OR_OTHER||Least squares mean difference|0.008||||0.756|TWO_SIDED|95.0|-0.044|0.06|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.060|-0.044|0.756
73887302|NCT01054885|147308803|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1|||<|0.001|TWO_SIDED|95.0|0.048|0.151|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.151|0.048|<0.001
73887303|NCT01054885|147308803|SUPERIORITY_OR_OTHER||Least squares mean difference|0.144|||<|0.001|TWO_SIDED|95.0|0.091|0.197||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.197|0.091|<0.001
73887304|NCT01054885|147308803|SUPERIORITY_OR_OTHER||Least squares mean difference|0.131|||<|0.001|TWO_SIDED|95.0|0.08|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.183|0.080|<0.001
73887305|NCT01054885|147308803|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1|||<|0.001|TWO_SIDED|95.0|0.047|0.152||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.152|0.047|<0.001
73887306|NCT01054885|147308803|SUPERIORITY_OR_OTHER||Least squares mean difference|0.123|||<|0.001|TWO_SIDED|95.0|0.072|0.174||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.174|0.072|<0.001
73887307|NCT01054885|147308803|SUPERIORITY_OR_OTHER||Least squares mean difference|0.045||||0.093|TWO_SIDED|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.097|-0.008|0.093
73887308|NCT01054885|147308803|SUPERIORITY_OR_OTHER||Least squares mean difference|0.032||||0.224|TWO_SIDED|95.0|-0.019|0.083|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.083|-0.019|0.224
73887309|NCT01399372|147308815|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.015|TWO_SIDED|95.0|0.27|0.95||One-sided significance level = 0.15|Log Rank||Reference arm = Chemotherapy|Sample size of 89 provided 80% power to detect a hazard ratio of 0.63 at a one-sided alpha level of 0.15.||0.95|0.27|0.015
73887310|NCT01399372|147308816|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.48|TWO_SIDED|95.0|0.38|1.58||Two-sided significance level = 0.05|Log Rank||Reference arm = Chemotherapy|||1.58|0.38|0.48
73887311|NCT01399372|147308818|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||A mixed effects model of EORTC QLQ-C30 GHS was run with independent variables treatment arm, time, baseline Memorial Sloan-Kettering Cancer Center (MSKCC) recursive partitioning analysis (RPA) class, and baseline neurologic symptoms (none/minor vs. moderate/severe), including the interaction of treatment and time, representing difference in the longitudinal trajectory of the scores between the treatment arms. Prospectively, the interaction effect was of most interest and is reported here,||||0.005
73887312|NCT01399372|147308819|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.18|TWO_SIDED|95.0|0.21|1.31|||Gray's test||Reference arm = Chemotherapy arm|||1.31|0.21|0.18
73887313|NCT01432730|147308821|SUPERIORITY||Log mean difference (Active - Placebo)|-0.6027||||0.0003|TWO_SIDED|95.0|-0.9049|-0.3005|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||-0.3005|-0.9049|0.0003
73887314|NCT01432730|147308822|SUPERIORITY||Mean Difference (Final Values)|-25.57||||0.003|TWO_SIDED|95.0|-41.53|-9.62|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-9.62|-41.53|0.003
73887315|NCT01432730|147308823|SUPERIORITY||Log mean difference (Active - Placebo)|-0.4212||||0.057|TWO_SIDED|95.0|-0.8568|0.01438|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||0.01438|-0.8568|0.057
73887316|NCT01432730|147308824|SUPERIORITY||Mean Difference (Final Values)|-8.53||||0.172|TWO_SIDED|95.0|-20.93|3.87|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||3.87|-20.93|0.172
73887317|NCT01432730|147308825|SUPERIORITY||Log mean difference (Active - Placebo)|-0.582||||0.001|TWO_SIDED|95.0|-0.8934|-0.2707|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||-0.2707|-0.8934|0.001
73887318|NCT01432730|147308826|SUPERIORITY||Mean Difference (Final Values)|-2.538||||0.033|TWO_SIDED|95.0|-4.849|-0.227|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-0.227|-4.849|0.033
73887319|NCT01432730|147308827|SUPERIORITY||Median Difference (Final Values)|-2.267||||0.049|TWO_SIDED|95.0|-4.523|-0.01|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-0.010|-4.523|0.049
73887320|NCT01432730|147308828|SUPERIORITY||Mean Difference (Final Values)|-9.237||||0.018|TWO_SIDED|95.0|-16.759|-1.716|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-1.716|-16.759|0.018
73887321|NCT01432730|147308829|SUPERIORITY||Mean Difference (Final Values)|-21.25||||0.035|TWO_SIDED|95.0|-40.96|-1.54|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-1.54|-40.96|0.035
73887322|NCT03881852|147308844|SUPERIORITY||||||<|0.001||||||P-value calculated from LSMean|Mixed Models Analysis|||||||<0.001
73887323|NCT01421719|147308845|SUPERIORITY_OR_OTHER|||||||0.0087||95.0|||||t-test, 2 sided|||Paired t test comparison of baseline number of urinary leaks per day versus number of leaks per day at 6 month evaluation after treatment.||||0.0087
73887324|NCT00565084|147308854|SUPERIORITY_OR_OTHER||Difference in LS Means|0.06||||0.743||90.0|-0.23|0.35|||ANOVA|||Primary efficacy endpoint was assessed by an ANOVA model with terms for treatment, period, sequence, and patients within sequence. Efficacy advantage over placebo was assessed via the treatment difference in the least-squares (LS) means (ibuprofen vs. average of the 2 placebo treatments) from the ANOVA model and the 90% confidence interval (CI; one-sided alpha=0.05) of the LS mean difference will be assessed.||0.35|-0.23|0.743
73887325|NCT01298648|147308880|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed cases at Baseline and Week 4.||||||<0.0001
73887326|NCT01298648|147308882|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|Paired t-test using observed values at Baseline and Week 8.||||||<0.0001
73887327|NCT01298648|147308883|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed values at Baseline and Week 24.||||||<0.0001
73887328|NCT01774721|147308942|SUPERIORITY||Hazard Ratio (HR)|0.589|||<|0.0001|TWO_SIDED|95.0|0.469|0.739|||1-sided stratified log-rank test||Based on stratified Cox regression model|||0.739|0.469|<0.0001
73887329|NCT01774721|147308943|SUPERIORITY||Hazard Ratio (HR)|0.748||||0.0077|TWO_SIDED|95.0|0.591|0.947|||1-sided stratified log-rank test||Based on stratified Cox Regression model|||0.947|0.591|0.0077
73887330|NCT01774721|147308945|SUPERIORITY||Hazard Ratio (HR)|0.622|||<|0.0001|TWO_SIDED|95.0|0.497|0.779|||1-sided stratified log-rank test||Based on stratified Cox regression model|||0.779|0.497|<0.0001
73887331|NCT01774721|147308948|SUPERIORITY||Hazard Ratio (HR)|0.403|||<|0.0001|TWO_SIDED|95.0|0.307|0.529|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on IRC review||0.529|0.307|<0.0001
73887332|NCT01774721|147308948|SUPERIORITY||Hazard Ratio (HR)|0.545|||<|0.0001|TWO_SIDED|95.0|0.418|0.711|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on Investigator assessment||0.711|0.418|<0.0001
73887333|NCT01774721|147308949|SUPERIORITY|||||||0.1942|||||||Cochran-Mantel-Haenszel|||||||0.1942
73887334|NCT01774721|147308950|SUPERIORITY|||||||0.0924|||||||Cochran-Mantel-Haenszel|||||||0.0924
73887335|NCT01774721|147308957|SUPERIORITY||Cox Proportional Hazard|1.173||||0.1641|TWO_SIDED|95.0|0.928|1.483|||Unstratified Log-rank Test|||||1.483|0.928|0.1641
73887336|NCT02399163|147308971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.76|||<|0.0001|TWO_SIDED|95.0|11.061|22.454||From ANOVA: participant (random), treatment (fixed), period (fixed)|ANCOVA||Difference is Placebo dentifrice/Fluoride rinse minus Placebo dentifrice/No rinse such that a positive difference implies a larger response value for the Placebo dentifrice/Fluoride rinse.|||22.454|11.061|<0.0001
73887337|NCT01907854|147308999|SUPERIORITY_OR_OTHER||Treatment difference|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.4|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Changes in HbA1c from baseline to the 26 weeks measurements were analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \>8.5%), metformin dose (\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the HbA1c value at baseline as a covariate, all variables nested within week as a factor.||-0.40|-0.82|<0.0001
73887338|NCT01907854|147309000|SUPERIORITY_OR_OTHER||Treatment difference|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.34|-0.99|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Change in body weight from baseline to the 26 weeks measurements was analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \>8.5%), metformin dose (\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the body weight at baseline as a covariate and all variables nested within week as a factor.||-0.99|-2.34|<0.0001
73887339|NCT02215252|147309006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|0.355|||TWO_SIDED|90.0|-1.0|0.17||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.||0.17|-1.00|
73887340|NCT02215252|147309006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|0.23|||TWO_SIDED|90.0|-0.91|-0.2||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.||-0.20|-0.91|
73887341|NCT02215252|147309007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91|||||TWO_SIDED|90.0|0.78|4.69||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||4.69|0.78|
73887342|NCT02215252|147309007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||||TWO_SIDED|90.0|1.06|6.56||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||6.56|1.06|
73887343|NCT02215252|147309008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|90.0|0.33|4.74||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||4.74|0.33|
73887344|NCT02215252|147309008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.75|||||TWO_SIDED|90.0|1.43|15.81||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||15.81|1.43|
73887345|NCT02215252|147309009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-1.75|-0.32||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.32|-1.75|
73887346|NCT02215252|147309009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-1.43|0.04||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.04|-1.43|
73887347|NCT02215252|147309010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|90.0|-0.86|0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.43|-0.86|
73887348|NCT02215252|147309010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|90.0|-1.33|0.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.00|-1.33|
73887349|NCT02215252|147309011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|90.0|-0.87|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.67|-0.87|
73887350|NCT02215252|147309011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|90.0|-1.36|0.2||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.20|-1.36|
73887351|NCT02215252|147309012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.49|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.67|-0.49|
73887352|NCT02215252|147309012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.13||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.13|-1.05|
73887353|NCT02215252|147309013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.09|0.39||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.39|-1.09|
73887354|NCT02215252|147309013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.0|0.51||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.51|-1.00|
73887355|NCT02215252|147309014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|90.0|-5.12|4.57||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||4.57|-5.12|
73887356|NCT02215252|147309014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.61|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|90.0|-10.57|-0.66||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.66|-10.57|
74079734|NCT01175135|147712994|OTHER||LS Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|1.907||0.093|TWO_SIDED|80.0|0.08|4.99||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||4.99|0.08|0.0930
74079735|NCT03325881|147713048|SUPERIORITY||Difference in LS Mean|-1.9|STANDARD_ERROR_OF_MEAN|2.48||0.451|TWO_SIDED|95.0|-6.8|3.1|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the linear mixed-effects model for repeated measures (MMRM) that included treatment group, nominal visit, age group, interaction of the treatment group with the visits as factors, baseline ADHD-RS5 total score as a covariate and an adjustment for the interaction of the baseline ADHD-RS-5 Total Score with the visit.||3.1|-6.8|0.451
74079736|NCT03325881|147713049|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.597|TWO_SIDED|95.0|-0.5|0.3|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the mixed effects model for repeated measures (MMRM) that includes treatment group, nominal visit, age group,interaction of the treatment group with the visit as factors, baseline CGI-S as a covariate and an adjustment for the interaction of the baseline CGI-S with the visit.||0.3|-0.5|0.597
74079737|NCT02052895|147713059|SUPERIORITY_OR_OTHER||Difference of ROC-AUC|0.0317||||0.3924|TWO_SIDED|95.0|-0.0409|0.1043|||Regression, Logistic|||||0.1043|-0.0409|0.3924
74079738|NCT03060486|147713060|OTHER||Signed Rank Score Difference|-60.0|||<|0.0001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<.0001
74079739|NCT03676634|147713061|OTHER||single proportion|0.844|||||TWO_SIDED|95.0|0.672|0.947|||||Values listed in table are for Type A. Estimated Value for the Estimation Parameter for type B = 0.875. Lower limit = 0.710, upper limit = 0.965|Consider increase from baseline to post-dose values. Parameter is proportion achieving desired increase (≥ 3x or 4x increase in Type A and Type B NAC).|Proportion of participants achieving ≥ 3x or 4x increase in NAC values was calculated for both Type A and Type B. Primary endpoint was achieved if both Type A and Type B had proportion ≥50%.|.947|.672|
74079740|NCT03131895|147713073|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) confidence intervals (CIs) on the original scale.|Least square (LS) mean ratio|1.0436||||0.5535|TWO_SIDED|90.0|0.9453|1.1521|||ANOVA|||||1.1521|0.9453|0.5535
74079741|NCT03131895|147713073|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0185||||0.892|TWO_SIDED|90.0|0.9334|1.1113|||ANOVA|||||1.1113|0.9334|0.8920
74079742|NCT03131895|147713074|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.039||||0.3209|TWO_SIDED|90.0|0.9792|1.1024|||ANOVA|||||1.1024|0.9792|0.3209
74079743|NCT03131895|147713074|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0353||||0.3896|TWO_SIDED|90.0|0.9719|1.1029|||ANOVA|||||1.1029|0.9719|0.3896
74079744|NCT03131895|147713075|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0335||||0.4163|TWO_SIDED|90.0|0.9733|1.0975|||ANOVA|||||1.0975|0.9733|0.4163
74079745|NCT03131895|147713075|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0031||||0.9778|TWO_SIDED|90.0|0.9458|1.0638|||ANOVA|||||1.0638|0.9458|0.9778
74079746|NCT00540423|147713076|SUPERIORITY_OR_OTHER||Risk Difference (RD)|60.0||||||95.0|35.21|84.79|||||The units of risk difference is percentage.|||84.79|35.21|
74079747|NCT00540423|147713078|SUPERIORITY_OR_OTHER||Percentage of 75% responders|43.5||||||95.0|23.19|65.51|||||Confidence interval of the percentage of participants for whom at least 75% of their assessments during the course of 26 weeks of SB-494115-GR treatment met the definition of responders.|||65.51|23.19|
74079748|NCT05143047|147713140|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
74079749|NCT05143047|147713141|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
74079750|NCT05143047|147713142|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
74079751|NCT05143047|147713143|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
74079752|NCT05143047|147713144|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
74079753|NCT05143047|147713145|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
74079754|NCT05143047|147713146|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
74079755|NCT05143047|147713147|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
74079756|NCT05143047|147713148|SUPERIORITY|||||||0.22|||||||Fisher Exact|||||||0.22
74079757|NCT00911274|147713190|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.41||||||90.0|82.77|103.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.18|82.77|
73887357|NCT02215252|147309015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|90.0|0.34|1.45||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.||1.45|0.34|
73887358|NCT02215252|147309015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|90.0|0.24|1.07||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.||1.07|0.24|
73887359|NCT02215252|147309016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.16|-0.02||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.02|-1.16|
73887360|NCT02215252|147309016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.57|-0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.43|-1.57|
73887361|NCT02215252|147309017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|192.0|STANDARD_ERROR_OF_MEAN|816.0|||TWO_SIDED|90.0|-1161.0|1544.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||1544|-1161|
73887362|NCT02215252|147309017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|611.0|STANDARD_ERROR_OF_MEAN|812.0|||TWO_SIDED|90.0|-735.0|1956.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||1956|-735|
73887363|NCT02215252|147309021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|STANDARD_ERROR_OF_MEAN|3.03|||TWO_SIDED|90.0|2.98|13.01||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||13.01|2.98|
73887364|NCT02215252|147309021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|3.14|||TWO_SIDED|90.0|-4.46|5.95||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||5.95|-4.46|
73887365|NCT02215252|147309022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.55|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|90.0|2.94|20.17||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||20.17|2.94|
73887366|NCT02215252|147309022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|90.0|-11.38|6.54||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||6.54|-11.38|
73887367|NCT02633306|147309024|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
74079758|NCT00911274|147713191|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.3||||||90.0|97.84|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.88|97.84|
73887368|NCT02633306|147309025|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
73887369|NCT02633306|147309026|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
74079759|NCT00911274|147713192|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|97.77|104.34|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.34|97.77|
74079760|NCT02960295|147713201|OTHER|There was no comparison group and no test of statistical significance.||||||||||||||||In this interventional study the number of glucose checks per patient per day was calculated as stated above. There was no comparison group and no test of statistical significance.|This is a simple calculation of the mean (sd) of the number of glucose checks per pt per day|||
74079761|NCT02960295|147713202|OTHER|This is an observational study|||||<|0.05|||||||Pearson correlation (r)|||||||<0.05
74079762|NCT02960295|147713202|OTHER|This is an observational study|||||<|0.05|||||||Pearson correlation coefficient (r)|||||||<0.05
74079763|NCT02960295|147713202|OTHER||||||<|0.05|||||||Pearson correlation coefficient (r)|||||||<0.05
73887370|NCT02633306|147309027|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
73887371|NCT02633306|147309028|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
73887372|NCT02633306|147309029|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
73887373|NCT02633306|147309030|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
73887374|NCT01598532|147309073|SUPERIORITY_OR_OTHER||||||<|0.004|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments||||<0.004
73887375|NCT01598532|147309074|SUPERIORITY_OR_OTHER||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments||||<0.003
73887376|NCT01598532|147309075|SUPERIORITY_OR_OTHER||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for effect of LED treatments||||<0.003
73887377|NCT01598532|147309076|SUPERIORITY_OR_OTHER||||||<|0.006|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effects of LED treatments||||<0.006
73887378|NCT00912808|147309079|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.||||0.049
73887379|NCT00912808|147309080|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.||||0.27
73887380|NCT03873116|147309081|SUPERIORITY||negative binomial regression model|-24.6||||0.181|TWO_SIDED|95.0|-50.1|14.0|||negative binomial regression model|||||14.0|-50.1|0.181
73887381|NCT03873116|147309081|SUPERIORITY||negative binomial regression model|-49.1||||0.003|TWO_SIDED|95.0|-67.5|-20.4|||negative binomial regression model|||||-20.4|-67.5|0.003
73887382|NCT03873116|147309084|SUPERIORITY||Difference in Least Square Means|0.018||||0.814|TWO_SIDED|95.0|-0.143|0.179|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms.||0.179|-0.143|0.814
73887383|NCT03873116|147309084|SUPERIORITY||Difference in Least Square Means|-0.122||||0.12|TWO_SIDED|95.0|-0.28|0.036|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms.||0.036|-0.280|0.120
74079764|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.647||||0.22|TWO_SIDED|95.0|0.322|1.302|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% confidence intervals (CIs).||1.302|0.322|0.22
74079765|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.647||||0.24|TWO_SIDED|95.0|0.322|1.301|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.301|0.322|0.24
74079766|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.83|TWO_SIDED|95.0|0.501|2.405|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.405|0.501|0.83
74079767|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.074||||0.87|TWO_SIDED|95.0|0.49|2.356|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.356|0.490|0.87
74079768|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.96|TWO_SIDED|95.0|0.458|2.131|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.131|0.458|0.96
74079769|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.592||||0.16|TWO_SIDED|95.0|0.289|1.212|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.212|0.289|0.16
74079770|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.551||||0.035|TWO_SIDED|95.0|0.324|0.937|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.937|0.324|0.035
74079771|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.624||||0.07|TWO_SIDED|95.0|0.373|1.045|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.045|0.373|0.070
74079772|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.085||||0.79|TWO_SIDED|95.0|0.605|1.947|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.947|0.605|0.79
74079773|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.959||||0.99|TWO_SIDED|95.0|0.527|1.743|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.743|0.527|0.99
74079774|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.78|TWO_SIDED|95.0|0.488|1.593|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.593|0.488|0.78
74079775|NCT00205777|147713211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.036|TWO_SIDED|95.0|0.34|0.968|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.968|0.340|0.036
74079776|NCT00205777|147713212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.097|TWO_SIDED|95.0|0.339|1.099|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.099|0.339|0.097
74079777|NCT00205777|147713212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.645||||0.15|TWO_SIDED|95.0|0.361|1.151|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.151|0.361|0.15
74079778|NCT00205777|147713212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.83|TWO_SIDED|95.0|0.493|1.793|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.793|0.493|0.83
74079779|NCT00205777|147713212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.067|TWO_SIDED|95.0|0.435|1.019|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.019|0.435|0.067
74079780|NCT00205777|147713212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.014|TWO_SIDED|95.0|0.367|0.896|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.896|0.367|0.014
74079781|NCT00205777|147713212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.157||||0.5|TWO_SIDED|95.0|0.71|1.885|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.885|0.710|0.50
73887384|NCT03873116|147309085|SUPERIORITY||mixed-model repeated measures analysis|24.5||||0.188|TWO_SIDED|95.0|-14.7|50.3|||mixed-model repeated measures analysis|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of rate of expert-confirmed angioedema events during dosing in the effective treatment period for statistical significance would not be completed. Therefore, P-values reported are nominal.||50.3|-14.7|0.188
74079782|NCT00205777|147713213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.085|TWO_SIDED|95.0|0.44|1.052|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.052|0.440|0.085
73887385|NCT03873116|147309085|SUPERIORITY||mixed-model repeated measures analysis|47.6||||0.005|TWO_SIDED|95.0|17.7|66.6|||mixed-model repeated measures analysis|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of rate of expert-confirmed angioedema events during dosing in the effective treatment period for statistical significance would not be completed. Therefore, P-values reported are nominal.||66.6|17.7|0.005
74079783|NCT00205777|147713213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.004|TWO_SIDED|95.0|0.434|0.857|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.857|0.434|0.004
74079784|NCT00205777|147713214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.621||||0.4|TWO_SIDED|95.0|0.203|1.903|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.903|0.203|0.40
74079785|NCT00205777|147713214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.504||||0.26|TWO_SIDED|95.0|0.151|1.676|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.676|0.151|0.26
74079786|NCT00205777|147713214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.33|TWO_SIDED|95.0|0.157|1.86|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.860|0.157|0.33
74079787|NCT00205777|147713214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.661||||0.49|TWO_SIDED|95.0|0.206|2.118|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||2.118|0.206|0.49
74079788|NCT00205777|147713214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.76|TWO_SIDED|95.0|0.305|2.37|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||2.370|0.305|0.76
74079789|NCT00205777|147713214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.238||||0.75|TWO_SIDED|95.0|0.332|4.616|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||4.616|0.332|0.75
73887386|NCT03873116|147309086|SUPERIORITY||mixed-model repeated measures analysis|-12.65||||0.213|TWO_SIDED|95.0|-33.33|8.03|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of change from baseline in AE-QoL total score at Week 24 for statistical significance would not be completed. P-values that are reported are nominal.||8.03|-33.33|0.213
73887387|NCT03873116|147309086|SUPERIORITY||mixed-model repeated measures analysis|-19.0||||0.061|TWO_SIDED|95.0|-39.0|0.99|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of change from baseline in AE-QoL total score at Week 24 for statistical significance would not be completed. P-values that are reported are nominal.||0.99|-39.00|0.061
73887388|NCT03755934|147309157|SUPERIORITY||LS mean estimate|-1.96|STANDARD_ERROR_OF_MEAN|0.961||0.0437|TWO_SIDED|95.0|-3.87|-0.06||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||-0.06|-3.87|0.0437
73887389|NCT03755934|147309157|SUPERIORITY||LS mean estimate|0.72|STANDARD_ERROR_OF_MEAN|0.541||0.1878|TWO_SIDED|95.0|-0.36|1.79||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||1.79|-0.36|0.1878
73887390|NCT03755934|147309157|SUPERIORITY||LS mean estimate|-1.39|STANDARD_ERROR_OF_MEAN|0.407||0.0009|TWO_SIDED|95.0|-2.19|-0.58||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||-0.58|-2.19|0.0009
73887391|NCT00198822|147309193|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65||||0.05|ONE_SIDED|95.0||0.99||We set an a priori level of statistical significance of p equal to 0.05.|generalized estimating equations|RR with 95% CIs were estimated by GEE binomial regression, with a log link function and exchangeable correlation appropriate for binary data.|The vitamin A group and the Beta-carotene group were compared to the placebo group.|Sample size was based on an expected placebo group MR of 600/100,000 pregnancies, requiring 18,000 pregnancies to detect a 35% reduction in all-cause mortality, with a 5% type I error, 80% power, 1.21 design effect, 15% early pregnancy loss and 10% loss to follow-up. A mid-study DSMB analysis suggested a lower MR, leading the SS to be increased to 67,740. However, with no mortality difference evident at a DSMB meeting in Dec 2006, the trial was halted leaving 59,721 in the trial cohort.||0.99||0.05
73887392|NCT02420821|147309198|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0205|TWO_SIDED|95.0|0.57|0.95|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.95|0.57|0.0205
73887393|NCT02420821|147309200|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2675|TWO_SIDED|95.0|0.76|1.08|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.08|0.76|0.2675
73887394|NCT02420821|147309202|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.263|TWO_SIDED|95.0|0.64|1.13|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.13|0.64|0.263
73887395|NCT02420821|147309204|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1218|TWO_SIDED|95.0|0.74|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.04|0.74|0.1218
73887396|NCT02420821|147309206|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6138|TWO_SIDED|95.0|0.72|1.21|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.21|0.72|0.6138
73887397|NCT02420821|147309207|SUPERIORITY||Difference in Response Rates|3.3||||0.2733|TWO_SIDED|95.0|-3.09|9.7|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||9.70|-3.09|0.2733
73887398|NCT02420821|147309209|SUPERIORITY||Difference in Response Rates|1.96||||0.5121|TWO_SIDED|95.0|-4.32|8.24|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||8.24|-4.32|0.5121
73887399|NCT02420821|147309212|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0606|TWO_SIDED|95.0|0.71|1.01|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.01|0.71|0.0606
73887400|NCT02420821|147309213|SUPERIORITY||Difference in Response Rates|5.09||||0.1011|TWO_SIDED|95.0|-1.4|11.58|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||11.58|-1.40|0.1011
73887401|NCT02420821|147309216|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0254|TWO_SIDED|95.0|0.7|0.98|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.98|0.70|0.0254
73887402|NCT02420821|147309218|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.002|TWO_SIDED|95.0|0.34|0.79|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.79|0.34|0.0020
73887403|NCT02420821|147309220|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0497|TWO_SIDED|95.0|0.43|1.0|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.00|0.43|0.0497
73887404|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.74|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.43|-1.06|<0.0001
73887405|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.2||||0.2085|TWO_SIDED|95.0|-0.51|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.11|-0.51|0.2085
73887406|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.71|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.71|-1.33|<0.0001
73887407|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.51||||0.0013|TWO_SIDED|95.0|-0.82|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.20|-0.82|0.0013
73887408|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.7|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.70|-1.34|<0.0001
73887409|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.43||||0.0098|TWO_SIDED|95.0|-0.76|-0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.10|-0.76|0.0098
73887410|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.65|-1.32|<0.0001
73887411|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.46||||0.008|TWO_SIDED|95.0|-0.8|-0.12|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.12|-0.80|0.0080
73887412|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.44|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.44|-1.13|<0.0001
73887413|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.21||||0.2512|TWO_SIDED|95.0|-0.56|0.15|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.15|-0.56|0.2512
73887414|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.65||||0.0005|TWO_SIDED|95.0|-1.01|-0.28|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.28|-1.01|0.0005
73887415|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.43||||0.0247|TWO_SIDED|95.0|-0.8|-0.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.05|-0.80|0.0247
73887416|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.39|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.39|-1.15|<0.0001
73887417|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.29||||0.1411|TWO_SIDED|95.0|-0.68|0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.10|-0.68|0.1411
73887418|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.65||||0.0014|TWO_SIDED|95.0|-1.05|-0.25|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.25|-1.05|0.0014
73888502|NCT05465317|147309648|OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.7|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.70|0.10
73887419|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.37||||0.0728|TWO_SIDED|95.0|-0.78|0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.03|-0.78|0.0728
73887420|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.49|-1.32|<0.0001
73887421|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.62||||0.0041|TWO_SIDED|95.0|-1.05|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.20|-1.05|0.0041
73887422|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.55|-1.46|<0.0001
73887423|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.5||||0.0353|TWO_SIDED|95.0|-0.96|-0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.03|-0.96|0.0353
73887424|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.85||||0.0011|TWO_SIDED|95.0|-1.35|-0.34|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.34|-1.35|0.0011
73887425|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.5||||0.0582|TWO_SIDED|95.0|-1.01|0.02|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.02|-1.01|0.0582
73887426|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.76||||0.0089|TWO_SIDED|95.0|-1.32|-0.19|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.19|-1.32|0.0089
73887427|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|0.02||||0.9575|TWO_SIDED|95.0|-0.57|0.61|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.61|-0.57|0.9575
73887428|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.36||||0.2745|TWO_SIDED|95.0|-1.01|0.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.29|-1.01|0.2745
73888503|NCT05465317|147309649|OTHER||Hazard Ratio (HR)|0.9||||0.32|TWO_SIDED|95.0|0.72|1.11|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.11|0.72|0.32
73887429|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.13||||0.7088|TWO_SIDED|95.0|-0.81|0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.55|-0.81|0.7088
73887430|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.39||||0.3077|TWO_SIDED|95.0|-1.13|0.36|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.36|-1.13|0.3077
73887431|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.15||||0.7112|TWO_SIDED|95.0|-0.93|0.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.63|-0.93|0.7112
73887432|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|-0.79||||0.0837|TWO_SIDED|95.0|-1.69|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.11|-1.69|0.0837
73887433|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|0.08||||0.8655|TWO_SIDED|95.0|-0.88|1.04|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.04|-0.88|0.8655
73887434|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|0.02||||0.9725|TWO_SIDED|95.0|-1.07|1.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.11|-1.07|0.9725
73887435|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|0.38||||0.5285|TWO_SIDED|95.0|-0.8|1.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.55|-0.80|0.5285
73887436|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|0.03||||0.9663|TWO_SIDED|95.0|-1.34|1.4|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.40|-1.34|0.9663
73887437|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|0.01||||0.9914|TWO_SIDED|95.0|-1.61|1.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.63|-1.61|0.9914
73887438|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|0.22||||0.8345|TWO_SIDED|95.0|-1.85|2.3|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||2.30|-1.85|0.8345
73888504|NCT05465317|147309649|OTHER||Hazard Ratio (HR)|0.9||||0.5|TWO_SIDED|95.0|0.65|1.24|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.24|0.65|0.50
73888505|NCT05465317|147309649|OTHER||Hazard Ratio (HR)|0.91||||0.5|TWO_SIDED|95.0|0.68|1.2|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.20|0.68|0.50
74079790|NCT00205777|147713215|SUPERIORITY_OR_OTHER||Relative Risk|0.9|||||TWO_SIDED|95.0|0.38|2.15||||||Relative risk versus placebo was provided together with 95% CIs.||2.15|0.38|
74079791|NCT00205777|147713215|SUPERIORITY_OR_OTHER||Relative Risk|0.92|||||TWO_SIDED|95.0|0.39|2.21||||||Relative risk versus placebo was provided together with 95% CIs.||2.21|0.39|
74079792|NCT00205777|147713216|SUPERIORITY_OR_OTHER||Relative risk|1.01|||||TWO_SIDED|95.0|0.5|2.06||||||Relative risk versus placebo was provided together with 95% CIs.||2.06|0.5|
74079793|NCT00205777|147713217|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Log Rank|||||||0.57
74079794|NCT00205777|147713217|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Log Rank|||||||0.62
74079795|NCT00205777|147713217|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Log Rank|||||||0.72
74079796|NCT00205777|147713217|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Log Rank|||||||0.67
74079797|NCT00205777|147713217|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Log Rank|||||||0.89
74079798|NCT00205777|147713217|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Log Rank|||||||0.95
74079799|NCT00205777|147713218|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||||||0.29
74079800|NCT00205777|147713218|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Log Rank|||||||0.31
74079801|NCT00205777|147713218|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Log Rank|||||||0.94
74079802|NCT00205777|147713219|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Log Rank|||||||0.18
74079803|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.46
74079804|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.90
74079805|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.93
74079806|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.84
74079807|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.39
74079808|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.52
74079809|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.28
74079810|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.31
74079811|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.17
74079812|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.72
74079813|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.97
74079814|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.76
74079815|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.29
74079816|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.43
74079817|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.59
74079818|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.19
74079819|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.80
74079820|NCT00205777|147713223|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.11
74079821|NCT00205777|147713224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.012||||0.968|TWO_SIDED|95.0|0.79|1.296|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.296|0.790|0.968
74079822|NCT00205777|147713224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.846||||0.211|TWO_SIDED|95.0|0.652|1.097|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.097|0.652|0.211
74079823|NCT00205777|147713224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.191|TWO_SIDED|95.0|0.925|1.556|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.556|0.925|0.191
74079824|NCT00205777|147713224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.493|TWO_SIDED|95.0|0.566|3.497|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||3.497|0.566|0.493
74079825|NCT00205777|147713224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872||||0.82|TWO_SIDED|95.0|0.316|2.405|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.405|0.316|0.820
74079826|NCT00205777|147713224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.612||||0.371|TWO_SIDED|95.0|0.624|4.161|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||4.161|0.624|0.371
74079827|NCT00205777|147713224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.423|TWO_SIDED|95.0|0.776|1.861|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.861|0.776|0.423
74079828|NCT00205777|147713224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.936||||0.799|TWO_SIDED|95.0|0.587|1.491|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.491|0.587|0.799
74079829|NCT00205777|147713224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.298|TWO_SIDED|95.0|0.818|2.002|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.002|0.818|0.298
74079830|NCT00205777|147713225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.73|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.19|0.78|0.73
74079831|NCT00205777|147713225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.71|TWO_SIDED|95.0|0.41|1.83|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.83|0.41|0.71
74079832|NCT00205777|147713225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.45|TWO_SIDED|95.0|0.8|1.66|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.66|0.80|0.45
74079833|NCT00205777|147713226|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||ANCOVA|||||||0.31
74079834|NCT00205777|147713226|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED||||||ANCOVA|||||||0.039
74079835|NCT00205777|147713226|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANCOVA|||||||0.13
74079836|NCT00205777|147713226|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
74079837|NCT00205777|147713226|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
74079838|NCT00205777|147713227|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
74079839|NCT00205777|147713227|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
74079840|NCT00205777|147713228|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||ANCOVA|||||||0.26
74079841|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using Analysis of covariance (ANCOVA).||||<0.001
74079842|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079843|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079844|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079845|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079846|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.018
74079847|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079848|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079849|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079850|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079851|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079852|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079853|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079854|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079855|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079856|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.036
74079857|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.003
74079858|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.019
74079859|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079860|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.002
74079861|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079862|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079863|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079864|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079865|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
73888506|NCT05465317|147309650|OTHER||Hazard Ratio (HR)|0.75||||0.005|TWO_SIDED|95.0|0.62|0.92|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.92|0.62|0.005
73887439|NCT02420821|147309221|SUPERIORITY||LS Mean Difference|0.5||||0.7725|TWO_SIDED|95.0|-2.9|3.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||3.91|-2.90|0.7725
73887440|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.49||||0.001|TWO_SIDED|95.0|-0.77|-0.2|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Pain: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.20|-0.77|0.0010
73887441|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.34|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Fatigue: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.34|-0.91|<0.0001
73887442|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.91|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.69|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Nausea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.69|-1.13|<0.0001
73887443|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.52||||0.0002|TWO_SIDED|95.0|-0.79|-0.25|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Disturbed sleep: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.25|-0.79|0.0002
73887444|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.84|-0.29|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feelings of being distressed: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.29|-0.84|<0.0001
73887445|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.81|-0.32|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Shortness of breath: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.32|-0.81|<0.0001
73887446|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.33||||0.0036|TWO_SIDED|95.0|-0.56|-0.11|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Remembering things: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.11|-0.56|0.0036
73887447|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-1.19|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.91|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Lack of appetite: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.91|-1.46|<0.0001
73887448|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.54||||0.0001|TWO_SIDED|95.0|-0.81|-0.27|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Drowsy: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.27|-0.81|0.0001
73887449|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.71|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Dry mouth: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.71|-1.28|<0.0001
74079866|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079867|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079868|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079869|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079870|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
73887450|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.87|-0.33|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feeling sad: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.33|-0.87|<0.0001
73887451|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.41|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Vomiting: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.41|-0.75|<0.0001
73887452|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.34||||0.0051|TWO_SIDED|95.0|-0.58|-0.1|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Numbness or tingling: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.10|-0.58|0.0051
73887453|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-1.08|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.83|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Rash/Skin Changes: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.83|-1.33|<0.0001
73887454|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-0.05||||0.6541|TWO_SIDED|95.0|-0.26|0.16|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Headache: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||0.16|-0.26|0.6541
73887455|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.76|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Mouth/Throat Sores: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.76|-1.28|<0.0001
73887456|NCT02420821|147309222|SUPERIORITY||LS Mean Difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.88|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Diarrhea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.88|-1.27|<0.0001
73887457|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.73|||<|0.0001|TWO_SIDED|95.0|0.58|0.87|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.87|0.58|<0.0001
73887458|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.57|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.57|0.28|<0.0001
73887459|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.55|0.84|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.84|0.55|<0.0001
74079871|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079872|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079873|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079874|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079875|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079876|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079877|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079878|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
73887460|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.73|0.44|<0.0001
73887461|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.77|||<|0.0001|TWO_SIDED|95.0|0.62|0.92|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.92|0.62|<0.0001
73887462|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.62|||<|0.0001|TWO_SIDED|95.0|0.46|0.78|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.78|0.46|<0.0001
73887463|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.82|||<|0.0001|TWO_SIDED|95.0|0.66|0.97|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.97|0.66|<0.0001
73887464|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.81|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.81|0.49|<0.0001
73887465|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.83|||<|0.0001|TWO_SIDED|95.0|0.66|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.99|0.66|<0.0001
73887466|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.46|0.8|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.80|0.46|<0.0001
73887467|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.72|||<|0.0001|TWO_SIDED|95.0|0.54|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|0.54|<0.0001
73887468|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.3|0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.65|0.30|<0.0001
73887469|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.68|||<|0.0001|TWO_SIDED|95.0|0.49|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.86|0.49|<0.0001
73887470|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.29|0.66|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.66|0.29|<0.0001
73887471|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.41|0.79|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.79|0.41|<0.0001
73887472|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|0.29|<0.0001
73887473|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.52|0.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.91|0.52|<0.0001
73887474|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.53|||<|0.0001|TWO_SIDED|95.0|0.33|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.73|0.33|<0.0001
73887475|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.74|||<|0.0001|TWO_SIDED|95.0|0.51|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.96|0.51|<0.0001
73887476|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.64|||<|0.0001|TWO_SIDED|95.0|0.41|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.86|0.41|<0.0001
73887477|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.74|||<|0.0001|TWO_SIDED|95.0|0.49|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.99|0.49|<0.0001
73887478|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.42||||0.001|TWO_SIDED|95.0|0.17|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|0.17|0.0010
73887479|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.32|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|0.32|<0.0001
73887480|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.52||||0.0005|TWO_SIDED|95.0|0.23|0.82|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.82|0.23|0.0005
73887481|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.56||||0.0008|TWO_SIDED|95.0|0.23|0.88|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.88|0.23|0.0008
73887482|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.33||||0.0591|TWO_SIDED|95.0|-0.01|0.67|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.67|-0.01|0.0591
74079879|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079880|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079881|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||0.008
74079882|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||0.007
74079883|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||0.002
74079884|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||0.002
74079885|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||0.006
74079886|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079887|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079888|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079889|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079890|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079891|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079892|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079893|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079894|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079895|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079896|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||0.47
74079897|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||0.005
74079898|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||0.002
74079899|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079900|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||0.004
74079901|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079902|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079903|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079904|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079905|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079906|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||0.39
74079907|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||0.17
74079908|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||0.34
74079909|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||0.016
74079910|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||0.47
74079911|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079912|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079913|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079914|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079915|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079916|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079917|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079918|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079919|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079920|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079921|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.01
74079922|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.002
74079923|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079924|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079925|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079926|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079927|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079928|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079929|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079930|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079931|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.048
74079932|NCT00205777|147713229|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.038
74079933|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079934|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079935|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079936|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079937|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079938|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079939|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079940|NCT00205777|147713229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079941|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079942|NCT00205777|147713230|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.010
74079943|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
74079944|NCT00205777|147713230|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.023
74079945|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079946|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079947|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079948|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079949|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079950|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079951|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079952|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079953|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079954|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
73887483|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.67||||0.0005|TWO_SIDED|95.0|0.29|1.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.05|0.29|0.0005
73887484|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.3||||0.1378|TWO_SIDED|95.0|-0.09|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|-0.09|0.1378
73887485|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.43||||0.065|TWO_SIDED|95.0|-0.03|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|-0.03|0.0650
73887486|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.48||||0.0531|TWO_SIDED|95.0|-0.01|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.96|-0.01|0.0531
73887487|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.93||||0.0011|TWO_SIDED|95.0|0.37|1.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.49|0.37|0.0011
73887488|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.55||||0.0708|TWO_SIDED|95.0|-0.05|1.14|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.14|-0.05|0.0708
73887489|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.58||||0.1078|TWO_SIDED|95.0|-0.13|1.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.29|-0.13|0.1078
73888507|NCT05465317|147309650|OTHER||Hazard Ratio (HR)|0.69||||0.03|TWO_SIDED|95.0|0.49|0.96|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.96|0.49|0.03
74079955|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079956|NCT00205777|147713230|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
74079957|NCT00205777|147713231|SUPERIORITY_OR_OTHER|||||||0.34|||||||ANCOVA|||Percent change at Month 72 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.34
74079958|NCT00205777|147713231|SUPERIORITY_OR_OTHER|||||||0.15|||||||ANCOVA|||Percent change at Month 84 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.15
74079959|NCT00205777|147713231|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 72 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079960|NCT00205777|147713231|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 84 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
74079961|NCT00205777|147713231|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Percent change at Month 72 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079962|NCT00205777|147713231|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 84 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
74079963|NCT00205777|147713231|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||Percent change at Month 72 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.003
74079964|NCT00205777|147713231|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Percent change at Month 84 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.002
74079965|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079966|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
73887490|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.62||||0.1487|TWO_SIDED|95.0|-0.22|1.47|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.47|-0.22|0.1487
73887491|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.33||||0.5537|TWO_SIDED|95.0|-0.77|1.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.43|-0.77|0.5537
73887492|NCT02420821|147309225|SUPERIORITY||LS Mean Difference|0.52||||0.5743|TWO_SIDED|95.0|-1.29|2.33|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||2.33|-1.29|0.5743
73887493|NCT04322526|147309233|OTHER|||||||0.01|||||||t-test, 2 sided|||Changes in BOLD signal in the rACC during the processing of contextual cues (pleasant \> unpleasant).||||0.01
73887494|NCT04322526|147309234|OTHER|Mechanistic hypothesis: naltrexone will block contextual processing.||||||0.0002|||||||t-test, 2 sided|||Changes in BOLD fMRI signal from the Placebo vs. the Naltrexone session.||||0.0002
73887495|NCT03955146|147309258|OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.062||0.2926|TWO_SIDED|95.0|-0.06|0.19|||Mixed Models Analysis|||||0.19|-0.06|0.2926
73887496|NCT02628873|147309274|EQUIVALENCE|Degree of agreement between the 2 Assessors|Degree of agreement / Kappa|0.48|||<|0.01|TWO_SIDED||||||Kappa|||||||< 0.01
73887497|NCT02628873|147309275|SUPERIORITY|T-test to determine whether one method had greater reported pain|Mean Difference (Final Values)|-0.925|STANDARD_DEVIATION|2.71|<|0.3|TWO_SIDED|95.0|-2.69|1.0|||t-test, 2 sided|||||1.00|-2.69|< 0.30
73887498|NCT02628873|147309276|SUPERIORITY||Mean Difference (Final Values)|-0.431|STANDARD_DEVIATION|2.76|<|0.67|TWO_SIDED|95.0|-2.4|1.56|||t-test, 2 sided|Paired t-test (pre-procedure versus post-procedure)||||1.56|-2.40|< 0.67
73887499|NCT03038100|147309311|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2785|TWO_SIDED|95.0|0.79|1.07|||Log Rank|||||1.07|0.79|0.2785
73887500|NCT03038100|147309312|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.8||||0.0376|TWO_SIDED|95.0|0.65|0.99|||Log Rank|||||0.99|0.65|0.0376
74079967|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
73887501|NCT03038100|147309313|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3432|TWO_SIDED|95.0|0.78|1.09|||Log Rank|||Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2), tumor PD-L1 status (IC0 vs. IC1/2/3), and treatment strategy (adjuvant vs. neoadjuvant).||1.09|0.78|0.3432
73887502|NCT03038100|147309314|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.83||||0.1316|TWO_SIDED|95.0|0.66|1.06|||Log Rank|||Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2) and treatment strategy (adjuvant vs. neoadjuvant).||1.06|0.66|0.1316
73887503|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.9096|TWO_SIDED|95.0|0.58|1.62|||Cochran-Mantel-Haenszel|||Emotional Functioning, Presurgical/Surgery||1.62|0.58|0.9096
73887504|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.21||||0.4662|TWO_SIDED|95.0|0.73|2.01|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 4 Day 1||2.01|0.73|0.4662
73887505|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.5237|TWO_SIDED|95.0|0.51|1.4|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 6 Day 1||1.40|0.51|0.5237
73887506|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.25||||0.3826|TWO_SIDED|95.0|0.76|2.07|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||2.07|0.76|0.3826
73887507|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9893|TWO_SIDED|95.0|0.56|1.76|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 12 Day 1||1.76|0.56|0.9893
73887508|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.89||||0.6892|TWO_SIDED|95.0|0.49|1.61|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 16 Day 1||1.61|0.49|0.6892
73887509|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.59||||0.1324|TWO_SIDED|95.0|0.3|1.17|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 20 Day 1||1.17|0.30|0.1324
73887510|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.03||||0.9176|TWO_SIDED|95.0|0.62|1.7|||Cochran-Mantel-Haenszel|||Emotional Functioning, Completion of Treatment/Early Termination Visit||1.70|0.62|0.9176
73887511|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.7861|TWO_SIDED|95.0|0.5|1.68|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 3 Months||1.68|0.50|0.7861
73887512|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.31||||0.4539|TWO_SIDED|95.0|0.65|2.65|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 6 Months||2.65|0.65|0.4539
73887513|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.71||||0.4849|TWO_SIDED|95.0|0.27|1.86|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 9 Months||1.86|0.27|0.4849
73887514|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.747|TWO_SIDED|95.0|0.19|3.34|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 12 Months||3.34|0.19|0.7470
74079968|NCT00205777|147713232|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.93
74079969|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079970|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079971|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079972|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079973|NCT00205777|147713232|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.30
74079974|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079975|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079976|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079977|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079978|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079979|NCT00205777|147713232|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079980|NCT00205777|147713233|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079981|NCT00205777|147713233|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079982|NCT00205777|147713233|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079983|NCT00205777|147713233|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
74079984|NCT00205777|147713234|SUPERIORITY_OR_OTHER|||||||0.037|||||||Ranked ANCOVA|||Percent change at Month 72 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.037
74079985|NCT00205777|147713234|SUPERIORITY_OR_OTHER|||||||0.16|||||||Ranked ANCOVA|||Percent change at Month 84 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.16
74079986|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74079987|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74079988|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74079989|NCT00205777|147713235|SUPERIORITY_OR_OTHER|||||||0.4|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.40
74079990|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74079991|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74079992|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74079993|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74079994|NCT00205777|147713235|SUPERIORITY_OR_OTHER|||||||0.004|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.004
74079995|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74079996|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74079997|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74079998|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74079999|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74080000|NCT00205777|147713235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74080001|NCT00205777|147713236|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74080002|NCT00205777|147713236|SUPERIORITY_OR_OTHER|||||||0.001|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.001
74080003|NCT00205777|147713236|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
74080004|NCT00205777|147713236|SUPERIORITY_OR_OTHER|||||||0.009|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.009
74080005|NCT00205777|147713237|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Ranked ANCOVA|||Percent change at Month 72 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.034
74080006|NCT00205777|147713237|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Ranked ANCOVA|||Percent change at Month 84 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.77
74080007|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080008|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080009|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080010|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080011|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080012|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080013|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080014|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||0.001
74080015|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080016|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080017|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080018|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080019|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||0.009
74080020|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
73887515|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33||||0.0896|TWO_SIDED|95.0|-44.86|100.0|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 18 Months||100.00|-44.86|0.0896
74080021|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||0.055
73887516|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Emotional Functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
74080022|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||0.004
74080023|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080024|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080025|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080026|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
74080027|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
74080028|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
74080029|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
74080030|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
74080031|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
74080032|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
74080033|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
74080034|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
73887517|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.7347|TWO_SIDED|95.0|0.56|1.5|||Cochran-Mantel-Haenszel|||Physical Functioning, Presurgical/Surgery||1.50|0.56|0.7347
73887518|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.56||||0.0479|TWO_SIDED|95.0|0.32|1.0|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 4 Day 1||1.00|0.32|0.0479
73887519|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.61||||0.0712|TWO_SIDED|95.0|0.36|1.05|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 6 Day 1||1.05|0.36|0.0712
73887520|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.8168|TWO_SIDED|95.0|0.56|1.58|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 8 Day 1||1.58|0.56|0.8168
73887521|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.6417|TWO_SIDED|95.0|0.5|1.52|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 12 Day 1||1.52|0.50|0.6417
73887522|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8821|TWO_SIDED|95.0|0.53|1.72|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 16 Day 1||1.72|0.53|0.8821
73887523|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.2158|TWO_SIDED|95.0|0.32|1.3|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 20 Day 1||1.30|0.32|0.2158
73887524|NCT03038100|147309320|SUPERIORITY||Odds Ratio (OR)|0.84||||0.4762|TWO_SIDED|95.0|0.51|1.37|||Cochran-Mantel-Haenszel|||Physical Functioning, Completion of Treatment/Early Termination Visit||1.37|0.51|0.4762
73887525|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.7585|TWO_SIDED|95.0|0.61|1.96|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 3 Months||1.96|0.61|0.7585
73887526|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9985|TWO_SIDED|95.0|0.52|1.93|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 6 Months||1.93|0.52|0.9985
73887527|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.07||||0.1067|TWO_SIDED|95.0|0.85|5.06|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 9 Months||5.06|0.85|0.1067
73887528|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.42||||0.6171|TWO_SIDED|95.0|0.36|5.61|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 12 Months||5.61|0.36|0.6171
73887529|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 18 Months||23.57|0.08|0.8084
73887530|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-50.0||||0.3173|TWO_SIDED|95.0|-100.0|94.3|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 24 Months||94.30|-100.00|0.3173
73887531|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.6802|TWO_SIDED|95.0|0.69|1.77|||Cochran-Mantel-Haenszel|||Global health status/QoL, Presurgical/Surgery||1.77|0.69|0.6802
73887532|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.347|TWO_SIDED|95.0|0.48|1.29|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 4 Day 1||1.29|0.48|0.3470
73887533|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.5564|TWO_SIDED|95.0|0.53|1.41|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 6 Day 1||1.41|0.53|0.5564
73887534|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.19||||0.5|TWO_SIDED|95.0|0.72|1.99|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 8 Day 1||1.99|0.72|0.5000
73887535|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9778|TWO_SIDED|95.0|0.57|1.78|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.78|0.57|0.9778
73887536|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.6005|TWO_SIDED|95.0|0.65|2.12|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||2.12|0.65|0.6005
73887537|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.5|2.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||2.00|0.50|0.9900
73887538|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.32||||0.2634|TWO_SIDED|95.0|0.81|2.15|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/Early Termination Visit||2.15|0.81|0.2634
73887539|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.964|TWO_SIDED|95.0|0.56|1.74|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.74|0.56|0.9640
73887540|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.76||||0.4117|TWO_SIDED|95.0|0.4|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.46|0.40|0.4117
73887541|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.51||||0.3505|TWO_SIDED|95.0|0.63|3.62|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 9 Months||3.62|0.63|0.3505
73887542|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.28||||0.2439|TWO_SIDED|95.0|0.55|9.45|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||9.45|0.55|0.2439
73887543|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33||||0.1573|TWO_SIDED|95.0|-44.86|100.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||100.00|-44.86|0.1573
73887544|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Global health status/QoL, Post-Treatment Follow Up 24 Months||100.00|-94.30|
73887545|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.72||||0.182|TWO_SIDED|95.0|0.45|1.16|||Cochran-Mantel-Haenszel|||Role Functioning, Presurgical/Surgery||1.16|0.45|0.1820
73887546|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.47||||0.0046|TWO_SIDED|95.0|0.28|0.8|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 4 Day 1||0.80|0.28|0.0046
74080035|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
74080036|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
74080037|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
74080038|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
74080039|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||0.012
74080040|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
74080041|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||0.031
74080042|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||0.008
74080043|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
74080044|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
74080045|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
74080046|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
74080047|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.001
73887547|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.59||||0.0361|TWO_SIDED|95.0|0.36|0.97|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 6 Day 1||0.97|0.36|0.0361
73887548|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.0848|TWO_SIDED|95.0|0.39|1.06|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.06|0.39|0.0848
73887549|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.1224|TWO_SIDED|95.0|0.37|1.13|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.13|0.37|0.1224
73887550|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.3127|TWO_SIDED|95.0|0.41|1.33|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.33|0.41|0.3127
73887551|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.6065|TWO_SIDED|95.0|0.42|1.65|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.65|0.42|0.6065
73887552|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.2173|TWO_SIDED|95.0|0.45|1.2|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.20|0.45|0.2173
73887553|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.1316|TWO_SIDED|95.0|0.35|1.15|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.15|0.35|0.1316
73887554|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.9||||0.7678|TWO_SIDED|95.0|0.46|1.76|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||1.76|0.46|0.7678
73887555|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.7331|TWO_SIDED|95.0|0.34|2.14|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||2.14|0.34|0.7331
73887556|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.83||||0.1235|TWO_SIDED|95.0|0.73|10.92|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||10.92|0.73|0.1235
73887557|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|0.0|||||TWO_SIDED|95.0|-84.09|84.09||||||Role functioning, Post-Treatment Follow Up 18 Months||84.09|-84.09|
73887558|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Role functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
73887559|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.7869|TWO_SIDED|95.0|0.65|1.78|||Cochran-Mantel-Haenszel|||Social functioning, Presurgical/Surgery||1.78|0.65|0.7869
73887560|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.2502|TWO_SIDED|95.0|0.43|1.25|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 4 Day 1||1.25|0.43|0.2502
73887561|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.5066|TWO_SIDED|95.0|0.5|1.41|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 6 Day 1||1.41|0.50|0.5066
73887562|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.8124|TWO_SIDED|95.0|0.56|1.59|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.59|0.56|0.8124
73887563|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.23||||0.4656|TWO_SIDED|95.0|0.7|2.17|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||2.17|0.70|0.4656
73887564|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.6725|TWO_SIDED|95.0|0.62|2.12|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||2.12|0.62|0.6725
73887565|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.82||||0.578|TWO_SIDED|95.0|0.41|1.64|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.64|0.41|0.5780
73887566|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.7611|TWO_SIDED|95.0|0.66|1.76|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/Early Termination Visit||1.76|0.66|0.7611
73887567|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.7588|TWO_SIDED|95.0|0.62|1.94|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.94|0.62|0.7588
73887568|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.6||||0.1428|TWO_SIDED|95.0|0.3|1.19|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||1.19|0.30|0.1428
73887569|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9802|TWO_SIDED|95.0|0.41|2.39|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||2.39|0.41|0.9802
73887570|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.34||||0.1967|TWO_SIDED|95.0|0.63|8.7|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||8.70|0.63|0.1967
73887571|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Difference in Proportion of Respnders|8.33||||0.4795|TWO_SIDED|95.0|-69.28|85.94|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||85.94|-69.28|0.4795
73887572|NCT03038100|147309320|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Social functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
73887573|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6651|TWO_SIDED|95.0|0.7|1.25|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 3 Day 1||1.25|0.70|0.6651
73887574|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9927|TWO_SIDED|95.0|0.75|1.34|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 5 Day 1||1.34|0.75|0.9927
73887575|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.03||||0.8209|TWO_SIDED|95.0|0.77|1.39|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||1.39|0.77|0.8209
73887576|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.6507|TWO_SIDED|95.0|0.79|1.45|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 12 Day 1||1.45|0.79|0.6507
74080048|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
74080049|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.001
74080050|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
74080051|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.10
74080052|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||0.89
74080053|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.60
74080054|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||0.82
74080055|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.001
74080056|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
74080057|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.012
74080058|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
74080059|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.083
74080060|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||0.96
74080061|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.84
74080062|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||0.15
74080063|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.13
74080064|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
74080065|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.007
74080066|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
74080067|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.28
74080068|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA||||0.10
74080069|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.94
74080070|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.46
74080071|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.63
74080072|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.70
74080073|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.58
74080074|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.29
74080075|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.59
74080076|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.036
74080077|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.57
74080078|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.49
74080079|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.038
74080080|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.93
74080081|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.96
74080082|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.72
74080083|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.12
74080084|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.043
74080085|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.53
74080086|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.75
74080087|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||<0.001
74080088|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
74080089|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
73887577|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.21||||0.2596|TWO_SIDED|95.0|0.87|1.67|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 16 Day 1||1.67|0.87|0.2596
73887578|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.6532|TWO_SIDED|95.0|0.75|1.58|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 20 Day 1||1.58|0.75|0.6532
73887579|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7592|TWO_SIDED|95.0|0.76|1.45|||Cochran-Mantel-Haenszel|||Emotional functioning, Completion Of Treatment/ Early Termination Visit||1.45|0.76|0.7592
73887580|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.7424|TWO_SIDED|95.0|0.62|1.4|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 3 Months||1.40|0.62|0.7424
73887581|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.37||||0.1912|TWO_SIDED|95.0|0.85|2.19|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 6 Months||2.19|0.85|0.1912
74080090|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
74080091|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.46
74080092|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||0.64
74080093|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||0.47
74080094|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||0.75
74080095|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.003
74080096|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
74080097|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
74080098|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
74080099|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.81
74080100|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||0.98
74080101|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||0.87
74080102|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||0.40
74080103|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.001
74080104|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
74080105|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
74080106|NCT00205777|147713238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
74080107|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.85
74080108|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.26
74080109|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.33
74080110|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.22
74080111|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.86
74080112|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.65
74080113|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||1.00
74080114|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.44
74080115|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.058
74080116|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.55
74080117|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.34
74080118|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.96
74080119|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.058
74080120|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.031
74080121|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.054
74080122|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.62
74080123|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.99
74080124|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.11
74080125|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.33
74080126|NCT00205777|147713238|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.65
74080127|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.97|||||||ANOVA|||BV: P value was calculated using Analysis of Variance (ANOVA).||||0.97
74080128|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.19
74080129|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.74
74080130|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.79
74080131|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.11
74080132|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.78
74080133|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.90
74080134|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.33
74080135|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.51
74080136|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.28
74080137|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.86|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.86
74080138|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.60
74080139|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.84
74080140|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.98
74080141|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.47|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.47
74080142|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.59|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.59
74080143|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.13
74080144|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.65
74080145|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.33
74080146|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.053|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.053
74080147|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.51
74080148|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.5|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.50
74080149|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.27
74080150|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.091|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.091
74080151|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.087|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.087
74080152|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.82
74080153|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.82
74080154|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.12
74080155|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.085|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.085
74080156|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.080
74080157|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.24
74080158|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.035|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.035
74080159|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.024
74080160|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.30
74080161|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.89|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.89
74080162|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.80
74080163|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.75|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.75
74080164|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.060
74080165|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.12
74080166|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.13
74080167|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.78
74080168|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.70
74080169|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.98
74080170|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||CP: P value was calculated using ANOVA.||||0.76
74080171|NCT00205777|147713239|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.73
74080172|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.70
74080173|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.65
74080174|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.006
74080175|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||OV: P value was calculated using ANOVA.||||0.010
74080176|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||OS: P value was calculated using ANOVA.||||0.050
74080177|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||OS: P value was calculated using ANOVA.||||0.045
74080178|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.18
74080179|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.56
74080180|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.14
74080181|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.22
74080182|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||MS: P value was calculated using ANOVA.||||0.11
74080183|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANOVA|||MS: P value was calculated using ANOVA.||||0.055
74080184|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||ANOVA|||ES: P value was calculated using ANOVA.||||0.069
74080185|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||ES: P value was calculated using ANOVA.||||0.28
74080186|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.62
74080187|NCT00205777|147713240|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.96
74080188|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.22
74080189|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.087
74080190|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.37
74080191|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.73
74080192|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.41
74080193|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.085
74080194|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.15
74080195|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.71
74080196|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.042
74080197|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.077
74080198|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.35
74080199|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.12
74080200|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.41
74080201|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.90
74080202|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.46
73887582|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.5526|TWO_SIDED|95.0|0.45|1.53|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 9 Months||1.53|0.45|0.5526
73887583|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.69||||0.3609|TWO_SIDED|95.0|0.32|1.52|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 12 Months||1.52|0.32|0.3609
73887584|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.7527|TWO_SIDED|95.0|0.2|3.23|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 18 Months||3.23|0.20|0.7527
73887585|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-33.33|||||TWO_SIDED|95.0|-100.0|75.44||||||Emotional functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|
73887586|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.3177|TWO_SIDED|95.0|0.62|1.17|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.17|0.62|0.3177
73887587|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4184|TWO_SIDED|95.0|0.63|1.21|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.21|0.63|0.4184
73887588|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.571|TWO_SIDED|95.0|0.67|1.24|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.24|0.67|0.5710
73887589|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.3973|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.19|0.65|0.3973
73887590|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.5163|TWO_SIDED|95.0|0.8|1.55|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.55|0.80|0.5163
73887591|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.6897|TWO_SIDED|95.0|0.64|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.35|0.64|0.6897
74080203|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.18
74080204|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.75
74080205|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.10
74080206|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.79
74080207|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.057
74080208|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.17
74080209|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.46
74080210|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.83
74080211|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.25
74080212|NCT00205777|147713241|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.35
74080213|NCT00205777|147713242|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.018
74080214|NCT00205777|147713242|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.29
74080215|NCT00205777|147713242|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.049
74080216|NCT00205777|147713242|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.37
74080217|NCT00205777|147713242|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.97
74080218|NCT00205777|147713242|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.78
74080219|NCT00205777|147713242|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.43
74080220|NCT00205777|147713242|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.32
74080221|NCT00205777|147713243|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||ANOVA|||||||0.35
74080222|NCT00205777|147713243|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||ANOVA|||||||0.66
74080223|NCT00205777|147713243|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANOVA|||||||0.30
74080224|NCT00205777|147713243|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||ANOVA|||||||0.95
74080225|NCT00205777|147713243|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
74080226|NCT00205777|147713244|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||ANOVA|||||||1.00
74080227|NCT00205777|147713244|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||||||0.40
74080228|NCT00205777|147713245|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||0.71
74080229|NCT00205777|147713245|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||||||0.83
74080230|NCT00205777|147713245|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|||||||0.63
74080231|NCT00205777|147713245|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||||||0.92
74080232|NCT00205777|147713245|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||ANOVA|||||||0.50
74080233|NCT00205777|147713246|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||||||0.73
74080234|NCT00205777|147713246|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
74080235|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.81
74080236|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.96
74080237|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.005
74080238|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.013
74080239|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.006
74080240|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.70
74080241|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.44
73887592|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.5735|TWO_SIDED|95.0|0.67|1.25|||Cochran-Mantel-Haenszel|||Physical functioning, Completion Of Treatment/ Early Termination Visit||1.25|0.67|0.5735
73887593|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.75||||0.1414|TWO_SIDED|95.0|0.5|1.1|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.10|0.50|0.1414
74080242|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.47
73887594|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8655|TWO_SIDED|95.0|0.59|1.55|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.55|0.59|0.8655
74080243|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.28
74080244|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.14
74080245|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.93
74080246|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.85
74080247|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.010
74080248|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.015
74080249|NCT00205777|147713247|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.006
74080250|NCT00205777|147713248|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.60
74080251|NCT00205777|147713248|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.53
74080252|NCT00205777|147713248|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||1.00
74080253|NCT00205777|147713248|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.43
74080254|NCT00205777|147713248|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.60
74080255|NCT00205777|147713248|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.52
74080256|NCT00205777|147713249|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
74080257|NCT00205777|147713249|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||||||0.76
74080258|NCT00205777|147713249|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||||||0.26
74080259|NCT00205777|147713249|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||||||0.90
74080260|NCT00205777|147713249|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
74080261|NCT00205777|147713250|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
74080262|NCT00205777|147713250|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
74080263|NCT00205777|147713251|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||ANOVA|||||||0.68
74080264|NCT00205777|147713251|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
74080265|NCT00205777|147713251|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
74080266|NCT00205777|147713251|SUPERIORITY_OR_OTHER|||||||0.088||95.0|||||ANOVA|||||||0.088
74080267|NCT00205777|147713251|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||||||0.17
74080268|NCT00205777|147713252|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
74080269|NCT00205777|147713252|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||||||0.10
74080270|NCT00205777|147713253|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.90
74080271|NCT00205777|147713253|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANOVA|||||||0.74
74080272|NCT00205777|147713253|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||||||0.13
74080273|NCT00205777|147713253|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||||||0.11
74080274|NCT00205777|147713253|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||ANOVA|||||||0.24
74080275|NCT00205777|147713254|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
74080276|NCT00205777|147713254|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANOVA|||||||0.070
74080277|NCT00205777|147713255|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||ANOVA|||||||0.77
74080278|NCT00205777|147713255|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANOVA|||||||0.91
74080279|NCT00205777|147713255|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
74080280|NCT00205777|147713255|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||||||0.023
74080281|NCT00205777|147713255|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANOVA|||||||0.012
74080282|NCT00205777|147713256|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||||||0.79
74080283|NCT00205777|147713256|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
74080284|NCT00205777|147713257|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||||||0.30
74080285|NCT00205777|147713257|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||||||0.62
74080286|NCT00205777|147713257|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||||||0.28
74080287|NCT00205777|147713257|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||ANOVA|||||||0.041
74080288|NCT00205777|147713257|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||||||0.12
74080289|NCT00205777|147713258|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||ANOVA|||||||0.70
74080290|NCT00205777|147713258|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
74080291|NCT00205777|147713259|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
74080292|NCT00205777|147713259|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||||||0.76
74080293|NCT00205777|147713259|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||||||0.26
74080294|NCT00205777|147713259|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANOVA|||||||0.89
74080295|NCT00205777|147713259|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||||||0.17
74080296|NCT00205777|147713260|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
74080297|NCT00205777|147713260|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
74080298|NCT00205777|147713261|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||||||0.97
74080299|NCT00205777|147713261|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
74080300|NCT00205777|147713261|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.050
74080301|NCT00205777|147713261|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||ANOVA|||||||0.061
73887595|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.72||||0.3017|TWO_SIDED|95.0|0.38|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||1.35|0.38|0.3017
73887596|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.6||||0.2325|TWO_SIDED|95.0|0.26|1.39|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||1.39|0.26|0.2325
73887597|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.33||||0.1717|TWO_SIDED|95.0|0.06|1.69|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||1.69|0.06|0.1717
73887598|NCT03038100|147309321|SUPERIORITY|Stratified Analsyis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-46.49|79.82||||||Physical functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|
73887599|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.4745|TWO_SIDED|95.0|0.84|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 3 Day 1||1.46|0.84|0.4745
73887600|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.5499|TWO_SIDED|95.0|0.69|1.22|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 5 Day 1||1.22|0.69|0.5499
73887601|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8436|TWO_SIDED|95.0|0.73|1.29|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 8 Day 1||1.29|0.73|0.8436
73887602|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.5798|TWO_SIDED|95.0|0.81|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.46|0.81|0.5798
73887603|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.9094|TWO_SIDED|95.0|0.74|1.39|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||1.39|0.74|0.9094
74080302|NCT00205777|147713261|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
73887604|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.4006|TWO_SIDED|95.0|0.81|1.67|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||1.67|0.81|0.4006
73887605|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4024|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/ Early Termination Visit||1.19|0.65|0.4024
74080303|NCT00205777|147713262|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||ANOVA|||||||0.15
74080304|NCT00205777|147713262|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANOVA|||||||0.056
74080305|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.20
74080306|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.12
74080307|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.17
74080308|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.92
74080309|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.86
74080310|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.18
74080311|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.12
74080312|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.096
74080313|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.76
74080314|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.93
74080315|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.36
74080316|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.34
74080317|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.98
74080318|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.35
74080319|NCT00205777|147713264|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.35
74080320|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.080
74080321|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.41
74080322|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.65
74080323|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.18
74080324|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.36
74080325|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.27
74080326|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.25
73887606|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8796|TWO_SIDED|95.0|0.67|1.41|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.41|0.67|0.8796
73887607|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.435|TWO_SIDED|95.0|0.53|1.32|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.32|0.53|0.4350
74080327|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.053
73887608|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.6225|TWO_SIDED|95.0|0.47|1.56|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 9 Months||1.56|0.47|0.6225
73887609|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.5775|TWO_SIDED|95.0|0.36|1.77|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||1.77|0.36|0.5775
73887610|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.37||||0.2343|TWO_SIDED|95.0|0.07|1.94|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||1.94|0.07|0.2343
74080328|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.40
74080329|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.45
74080330|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.012
74080331|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.54
74080332|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.11
74080333|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.35
74080334|NCT00205777|147713266|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.34
74080335|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.21
74080336|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.058
74080337|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.76
74080338|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.34
74080339|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.51
74080340|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.14
74080341|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.57
74080342|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.78
74080343|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.24
74080344|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.78
74080345|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.62
74080346|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.72
74080347|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.16
74080348|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.059
74080349|NCT00205777|147713268|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.30
74080350|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.72
74080351|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.98
74080352|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.84
74080353|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.88
74080354|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.86
74080355|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.82
74080356|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.11
74080357|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.14
74080358|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.22
74080359|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.88
74080360|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.96
74080361|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.76
74080362|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.92
73887611|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-66.67||||0.0833|TWO_SIDED|95.0|-100.0|4.39|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 24 Months||4.39|-100.00|0.0833
74080363|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.89
73887612|NCT03038100|147309321|SUPERIORITY|Superiority|Odds Ratio (OR)|0.93||||0.6012|TWO_SIDED|95.0|0.71|1.21|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.21|0.71|0.6012
74080364|NCT00205777|147713270|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.83
74080365|NCT00367133|147713272|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P values for two group comparisons for difference in mean change.||||0.02
74080366|NCT00367133|147713272|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change||||0.002
74080367|NCT00367133|147713272|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change||||0.49
74080368|NCT00367133|147713275|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.03
74080369|NCT00367133|147713275|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.01
74080370|NCT00367133|147713275|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.82
74080371|NCT00367133|147713276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P value not adjusted for multiple comparisons||||<0.001
74080372|NCT00367133|147713276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons||||<0.001
74080373|NCT00367133|147713276|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||0.91
74080374|NCT00367133|147713278|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
74080375|NCT00367133|147713278|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
74080376|NCT00367133|147713278|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons||||0.60
74080377|NCT00367133|147713279|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
74080378|NCT00367133|147713279|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis||||<0.001
74080379|NCT00367133|147713279|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis||||0.55
74080380|NCT02336074|147713287|SUPERIORITY|||||||0.26||||||Treatment arms were compared in terms of absolute total HIV DNA levels (on a log10-scale) at post-randomization weeks 16 and 18 adjusted for the baseline (i.e. randomization) level and by stratum.|Regression, Linear|||||||0.26
74080381|NCT02336074|147713289|SUPERIORITY||Odds Ratio (OR)|0.41||||0.145|TWO_SIDED||||||Regression, Logistic|||"Comparison of the proportion of patients with undetectable viral outgrowth using logistic regression.~The analysis was adjusted for stratum and baseline viral outgrowth. Missing baseline values were imputed."||||0.145
74080382|NCT00906399|147713294|SUPERIORITY_OR_OTHER||Rate Ratio|0.725||||0.0114|TWO_SIDED|95.0|0.565|0.93|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (\< 4 versus ≥ 4), baseline relapse rate, age (\< 40 versus ≥ 40 years).||||0.930|0.565|0.0114
74080383|NCT00906399|147713294|SUPERIORITY_OR_OTHER||Rate Ratio|0.644||||0.0007|TWO_SIDED|95.0|0.5|0.831|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (\< 4 versus ≥ 4), baseline relapse rate, age (\< 40 versus ≥ 40).||||0.831|0.500|0.0007
74080384|NCT00906399|147713295|SUPERIORITY_OR_OTHER||Lesion Mean Ratio|0.72||||0.0008|TWO_SIDED|95.0|0.6|0.87|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.||||0.87|0.60|0.0008
74080385|NCT00906399|147713295|SUPERIORITY_OR_OTHER||Lesion Mean Ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.27|0.4|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.||||0.40|0.27|<0.0001
74080386|NCT00906399|147713296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.02|TWO_SIDED|95.0|0.57|0.95||Based on Cox proportion hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4), age (\<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model|||||0.95|0.57|0.0200
74080387|NCT00906399|147713296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0003|TWO_SIDED|95.0|0.47|0.8||Based on Cox proportion hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4), age (\<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model|||||0.80|0.47|0.0003
74080388|NCT00906399|147713297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.038|TWO_SIDED|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4) and age (\< 40 versus ≥ 40 years).|Cox Proportion Hazards model|||||0.97|0.40|0.0380
74080389|NCT00906399|147713297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0383|TWO_SIDED|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4) and age (\< 40 versus ≥ 40 years).|Cox Proportion Hazards model|||||0.97|0.40|0.0383
74080390|NCT00836758|147713298|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
74080391|NCT01124786|147713300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.994|||<|0.973|TWO_SIDED|95.0|0.746|1.326|||Log Rank||Hazard ratio and confidence interval presented above, so parameter dispersion not indicated in standard deviation field directly above.|If the median Overall Survival (OS) for the CO-1.01-treated patients is 7.7 months and the median OS for gemcitabine-treated patients with hENT1-low status is 4 months (hazard ratio of 0.53), then a total of 144 events of death in the hENT1-low subgroup will provide over 90% power at a 0.05 (2 sided) significance level for the comparison of CO-1.01 to gemcitabine in the hENT1-low patients.||1.326|0.746|<0.973
74080392|NCT01665508|147713328|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were reported as the mean ± (SD) and categorical data presented as frequency and percentage of the sample. Comparisons between baseline and post-treatment SAQ scores, SF-36v2 scores, and CPET variables were performed using a paired t-test for normally distributed variables or a Wilcoxon signed-rank test for non-normally distributed variables. Normality was defined by the Shapiro-Wilk test. For categorical variables, data were compared using a chi-squared test.||||< 0.05
74080393|NCT00858780|147713338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.17||||0.007|TWO_SIDED|95.0|1.72|29.82|||GEE Model|||Analysis was performed using a generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||29.82|1.72|0.007
74080394|NCT00858780|147713338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.362|TWO_SIDED|95.0|0.54|5.41|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||5.41|0.54|0.362
74080395|NCT00858780|147713338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2||||0.044|TWO_SIDED|95.0|1.04|16.99|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||16.99|1.04|0.044
74080396|NCT03602339|147713361|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.455|||<|0.0001|TWO_SIDED|95.0|0.347|0.562||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.562|0.347|< 0.0001
74080397|NCT03602339|147713362|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.18|||=|0.0151|TWO_SIDED|95.0|0.017|0.342||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.342|0.017|= 0.0151
74080398|NCT03602339|147713363|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.15|||=|0.01|TWO_SIDED|95.0|0.024|0.275||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.275|0.024|= 0.0100
73887613|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.2291|TWO_SIDED|95.0|0.65|1.11|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.11|0.65|0.2291
73887614|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6574|TWO_SIDED|95.0|0.71|1.24|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.24|0.71|0.6574
73887615|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9217|TWO_SIDED|95.0|0.76|1.35|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.35|0.76|0.9217
73887616|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7693|TWO_SIDED|95.0|0.7|1.3|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.30|0.70|0.7693
73887617|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.647|TWO_SIDED|95.0|0.64|1.31|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.31|0.64|0.6470
73887618|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.6391|TWO_SIDED|95.0|0.7|1.25|||Cochran-Mantel-Haenszel|||Role functioning, Completion Of Treatment/ Early Termination Visit||1.25|0.70|0.6391
74080399|NCT03602339|147713364|NON_INFERIORITY|Non-inferiority margin is 0.35. If the lower limit of the 95% CI is \> -0.35, then non-inferiority is achieved.|Mean Difference (Final Values)|0.073|||||TWO_SIDED|95.0|-0.03|0.176||||||Difference (Gadobutrol - Gadoterate)||0.176|-0.030|
74080400|NCT03602339|147713365|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|-3.4|3.4|||||The 95% confidence intervals are based on McNemar's test.|Accuracy Difference (Gadobutrol - Gadoterate)||3.40|-3.40|
74080401|NCT03602339|147713365|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|-5.22|5.22|||||The 95% confidence intervals are based on McNemar's test.|Sensitivity Difference (Gadobutrol - Gadoterate)||5.22|-5.22|
74080402|NCT03602339|147713365|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The 95% confidence intervals are based on McNemar's test. No continuity correction for calculation of the confidence interval was included. Zero cells lead to degenerated confidence interval.|Specificity Difference (Gadobutrol - Gadoterate)||0.00|0.00|
74080403|NCT03602339|147713366|OTHER||Mean Difference (Final Values)|0.076|||||TWO_SIDED|95.0|0.011|0.14||||||Difference (Gadobutrol - Gadoterate)||0.140|0.011|
74080404|NCT03602339|147713367|OTHER||Mean Difference (Final Values)|0.0||||0.9149|TWO_SIDED|95.0|-0.1|0.11|||Wilcoxon signed-rank test|||Comparison of image quality between gadobutrol and gadoterate||0.11|-0.10|0.9149
74080405|NCT03602339|147713368|OTHER||Mean Difference (Final Values)|-0.01968|||||TWO_SIDED|95.0|-0.03491|-0.00445||||||Difference (Gadobutrol-Gadoterate) for Relative score||-0.00445|-0.03491|
74080406|NCT03602339|147713368|OTHER||Mean Difference (Final Values)|0.00586|||||TWO_SIDED|95.0|-0.00589|0.01762||||||Difference (Gadobutrol-Gadoterate) for Full image score||0.01762|-0.00589|
74080407|NCT03602339|147713368|OTHER||Mean Difference (Final Values)|0.00139|||||TWO_SIDED|95.0|-0.00471|0.00749||||||Difference (Gadobutrol-Gadoterate) for Dice score||0.00749|-0.00471|
74080408|NCT03602339|147713370|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate), and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0049||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0049
74080409|NCT03602339|147713371|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate) and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0013||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0013
74080410|NCT03602339|147713372|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate) and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0065||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0065
74080411|NCT02615249|147713380|OTHER||Kappa statistic|0.28|||||TWO_SIDED|95.0|-0.01|0.58||||||Comparison between 0.12 mg/cm2 copper sulfate and copper sulfate 2% in petrolatum||0.58|-0.01|
74080412|NCT02615249|147713380|OTHER||Kappa statistic|0.45|||||TWO_SIDED|95.0|0.24|0.66||||||Comparison between 0.24 mg/cm2 manganese chloride and manganese chloride 2% in petrolatum||0.66|0.24|
74080413|NCT02615249|147713380|OTHER||Kappa statistic|0.23|||||TWO_SIDED|95.0|0.07|0.38|||||Kappa statistic is for 0.33 mg/cm2 tin chloride vs 1% tin chloride in petrolatum reference allergen|Comparison between 0.33 mg/cm2 tin chloride and tin chloride 1% in petrolatum||0.38|0.07|
74080414|NCT02615249|147713380|OTHER||Kappa statistic|0.4|||||TWO_SIDED|95.0|0.15|0.65|||||Kappa statistic is for 0.22 mg Ti/cm2 ammonium titanium oxide oxalate vs 19% ammonium titanium oxide oxalate in petrolatum reference allergen|Comparison between 0.22 mg Ti/cm2 ammonium titanium oxide oxalate and ammnium titanium oxide oxalate 19% in petrolatum||0.65|0.15|
74080415|NCT02615249|147713380|OTHER||Kappa statistic|0.52|||||TWO_SIDED|95.0|0.3|0.73|||||Kappa statistic is for 0.050 mg V/cm2 vanadium sulfate vs 1.5% vanadium sulfate in petrolatum reference allergen|Comparison between 0.050 mg/cm2 vanadium sulfate and vanadium sulfate 1.5% in petrolatum||0.73|0.30|
74080416|NCT02615249|147713380|OTHER||Kappa statistic|0.36|||||TWO_SIDED|95.0|0.07|0.38|||||Kappa statistic is for 0.24 mg/cm2 zinc chloride vs 2% zinc chloride in petrolatum reference allergen|Comparison betweenm 0.24 mg/cm2 zinc chloride and zinc chloride 2% in petrolatum||0.38|0.07|
73887619|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.0892|TWO_SIDED|95.0|0.51|1.05|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.05|0.51|0.0892
73887620|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.65||||0.055|TWO_SIDED|95.0|0.41|1.01|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||1.01|0.41|0.0550
73887621|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.49||||0.0168|TWO_SIDED|95.0|0.27|0.88|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||0.88|0.27|0.0168
73887622|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.29||||0.0021|TWO_SIDED|95.0|0.13|0.65|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||0.65|0.13|0.0021
73887623|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.7817|TWO_SIDED|95.0|0.17|3.8|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||3.80|0.17|0.7817
73887624|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|-33.33|||||TWO_SIDED|95.0|-100.0|75.44||||||Role functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|
73887625|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.6646|TWO_SIDED|95.0|0.8|1.41|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 3 Day 1||1.41|0.80|0.6646
73887626|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8677|TWO_SIDED|95.0|0.73|1.3|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 5 Day 1||1.30|0.73|0.8677
73887627|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.767|TWO_SIDED|95.0|0.79|1.38|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.38|0.79|0.7670
73887628|NCT03038100|147309321|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7487|TWO_SIDED|95.0|0.71|1.28|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||1.28|0.71|0.7487
73887629|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.23||||0.1882|TWO_SIDED|95.0|0.9|1.68|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||1.68|0.90|0.1882
73887630|NCT03038100|147309321|SUPERIORITY||Odds Ratio (OR)|1.21||||0.3015|TWO_SIDED|95.0|0.84|1.72|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.72|0.84|0.3015
73887631|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.9059|TWO_SIDED|95.0|0.73|1.32|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/ Early Termination Visit||1.32|0.73|0.9059
73887632|NCT03038100|147309321|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7125|TWO_SIDED|95.0|0.65|1.35|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.35|0.65|0.7125
73887633|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.68||||0.0947|TWO_SIDED|95.0|0.43|1.07|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||1.07|0.43|0.0947
73887634|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.58||||0.0686|TWO_SIDED|95.0|0.32|1.05|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||1.05|0.32|0.0686
73887635|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.39||||0.0175|TWO_SIDED|95.0|0.17|0.86|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||0.86|0.17|0.0175
73887636|NCT03038100|147309321|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.46||||0.3376|TWO_SIDED|95.0|0.09|2.3|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||2.30|0.09|0.3376
73887637|NCT03038100|147309321|SUPERIORITY||Difference in Proportion of Responders|-50.0||||0.5637|TWO_SIDED|95.0|-100.0|23.34|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 24 Months||23.34|-100.00|0.5637
73887638|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.977|TWO_SIDED|95.0|0.76|1.3|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 3 Day 1||1.30|0.76|0.9770
73887639|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7317|TWO_SIDED|95.0|0.8|1.37|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 5 Day 1||1.37|0.80|0.7317
73887640|NCT03038100|147309322|SUPERIORITY||Odds Ratio (OR)|1.06||||0.6937|TWO_SIDED|95.0|0.8|1.39|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 8 Day 1||1.39|0.80|0.6937
73887641|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.3916|TWO_SIDED|95.0|0.66|1.18|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 12 Day 1||1.18|0.66|0.3916
73887642|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.3363|TWO_SIDED|95.0|0.63|1.17|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 16 Day 1||1.17|0.63|0.3363
73887643|NCT03038100|147309322|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6761|TWO_SIDED|95.0|0.75|1.55|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 20 Day 1||1.55|0.75|0.6761
73887644|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6997|TWO_SIDED|95.0|0.71|1.26|||Cochran-Mantel-Haenszel|||Emotional Functioning, Completion of Treatment/ Early Termination Visit||1.26|0.71|0.6997
73887645|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.19||||0.3592|TWO_SIDED|95.0|0.82|1.72|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 3 Months||1.72|0.82|0.3592
73887646|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8798|TWO_SIDED|95.0|0.62|1.51|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 6 Months||1.51|0.62|0.8798
73887647|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.77||||0.3857|TWO_SIDED|95.0|0.43|1.39|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 9 Months||1.39|0.43|0.3857
73887648|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.6854|TWO_SIDED|95.0|0.39|1.85|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 12 Months||1.85|0.39|0.6854
73887649|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.54||||0.4533|TWO_SIDED|95.0|0.11|2.7|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 18 Months||2.70|0.11|0.4533
73887650|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-33.33||||0.3173|TWO_SIDED|95.0|-100.0|75.44|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|0.3173
73887651|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.13||||0.3658|TWO_SIDED|95.0|0.87|1.47|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.47|0.87|0.3658
73887652|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.7619|TWO_SIDED|95.0|0.8|1.36|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.36|0.80|0.7619
73887653|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.658|TWO_SIDED|95.0|0.81|1.4|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.40|0.81|0.6580
73887654|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.18||||0.2726|TWO_SIDED|95.0|0.88|1.57|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.57|0.88|0.2726
73887655|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6973|TWO_SIDED|95.0|0.69|1.29|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.29|0.69|0.6973
73887656|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.15||||0.447|TWO_SIDED|95.0|0.8|1.64|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.64|0.80|0.4470
73887657|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.515|TWO_SIDED|95.0|0.68|1.21|||Cochran-Mantel-Haenszel|||Physical functioning, Completion of Treatment/ Early Termination Visit||1.21|0.68|0.5150
73887658|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.26||||0.2103|TWO_SIDED|95.0|0.88|1.82|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.82|0.88|0.2103
73887659|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.7969|TWO_SIDED|95.0|0.68|1.66|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.66|0.68|0.7969
73887660|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.83|TWO_SIDED|95.0|0.6|1.91|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||1.91|0.60|0.8300
73887661|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.6987|TWO_SIDED|95.0|0.53|2.55|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||2.55|0.53|0.6987
73887662|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|3.32||||0.1441|TWO_SIDED|95.0|0.62|17.77|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||17.77|0.62|0.1441
73887663|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Difference in proportion of Responders|-66.67||||0.3173|TWO_SIDED|95.0|-100.0|4.39|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 24 Months||4.39|-100.00|0.3173
73887664|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.7591|TWO_SIDED|95.0|0.74|1.25|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 3 Day 1||1.25|0.74|0.7591
73887665|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.5403|TWO_SIDED|95.0|0.83|1.42|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 5 Day 1||1.42|0.83|0.5403
73887666|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.2654|TWO_SIDED|95.0|0.89|1.55|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 8 Day 1||1.55|0.89|0.2654
73887667|NCT03038100|147309322|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5138|TWO_SIDED|95.0|0.82|1.48|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 12 Day 1||1.48|0.82|0.5138
73887668|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.22||||0.2138|TWO_SIDED|95.0|0.89|1.67|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 16 Day 1||1.67|0.89|0.2138
73887669|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.26||||0.2114|TWO_SIDED|95.0|0.88|1.82|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 20 Day 1||1.82|0.88|0.2114
73887670|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.3938|TWO_SIDED|95.0|0.85|1.53|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Completion of Treatment/ Early Termination Visit||1.53|0.85|0.3938
73887671|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7793|TWO_SIDED|95.0|0.65|1.38|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 3 Months||1.38|0.65|0.7793
73887672|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.737|TWO_SIDED|95.0|0.69|1.39|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 6 Months||1.39|0.69|0.7370
73887673|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9658|TWO_SIDED|95.0|0.55|1.79|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 9 Months||1.79|0.55|0.9658
73887674|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.66||||0.3015|TWO_SIDED|95.0|0.29|1.46|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 12 Months||1.46|0.29|0.3015
73887675|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.77||||0.7534|TWO_SIDED|95.0|0.15|3.94|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 18 Months||3.94|0.15|0.7534
73887676|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67||||0.5637|TWO_SIDED|95.0|-46.49|79.82|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 24 Months||79.82|-46.49|0.5637
73887677|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.1177|TWO_SIDED|95.0|0.61|1.06|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.06|0.61|0.1177
73887678|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.273|TWO_SIDED|95.0|0.88|1.56|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.56|0.88|0.2730
73887679|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9306|TWO_SIDED|95.0|0.73|1.33|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.33|0.73|0.9306
73887680|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8631|TWO_SIDED|95.0|0.72|1.32|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.32|0.72|0.8631
73887681|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.33||||0.0977|TWO_SIDED|95.0|0.95|1.86|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.86|0.95|0.0977
73887682|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.43||||0.0726|TWO_SIDED|95.0|0.97|2.1|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||2.10|0.97|0.0726
73887683|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9974|TWO_SIDED|95.0|0.73|1.38|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.38|0.73|0.9974
73887684|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.7069|TWO_SIDED|95.0|0.72|1.63|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.63|0.72|0.7069
73887685|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.3||||0.3068|TWO_SIDED|95.0|0.78|2.16|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||2.16|0.78|0.3068
73887686|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.64||||0.1375|TWO_SIDED|95.0|0.85|3.16|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||3.16|0.85|0.1375
73887687|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.954|TWO_SIDED|95.0|0.46|2.29|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||2.29|0.46|0.9540
73887688|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.53||||0.4283|TWO_SIDED|95.0|0.1|2.64|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||2.64|0.10|0.4283
73887689|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-95.56|100.0||||||Role functioning, Post-Treatment Follow Up 24 Months||100.00|-95.56|
73887690|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.2153|TWO_SIDED|95.0|0.64|1.1|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 3 Day 1||1.10|0.64|0.2153
73887691|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.7878|TWO_SIDED|95.0|0.73|1.27|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 5 Day 1||1.27|0.73|0.7878
73887692|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.81||||0.1544|TWO_SIDED|95.0|0.61|1.08|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 8 Day 1||1.08|0.61|0.1544
73887693|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.8017|TWO_SIDED|95.0|0.77|1.4|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 12 Day 1||1.40|0.77|0.8017
73887694|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4295|TWO_SIDED|95.0|0.63|1.21|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 16 Day 1||1.21|0.63|0.4295
73887695|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio, log|0.99||||0.954|TWO_SIDED|95.0|0.68|1.44|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 20 Day 1||1.44|0.68|0.9540
73887696|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7494|TWO_SIDED|95.0|0.69|1.3|||Cochran-Mantel-Haenszel|||Social Functioning, Completion of Treatment/ Early Termination Visit||1.30|0.69|0.7494
73887697|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.6412|TWO_SIDED|95.0|0.74|1.62|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 3 Months||1.62|0.74|0.6412
73887698|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.8652|TWO_SIDED|95.0|0.65|1.67|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 6 Months||1.67|0.65|0.8652
73887699|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.6912|TWO_SIDED|95.0|0.6|2.18|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 9 Months||2.18|0.60|0.6912
73887700|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.5834|TWO_SIDED|95.0|0.33|1.86|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 12 Months||1.86|0.33|0.5834
73887701|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.9578|TWO_SIDED|95.0|0.05|16.05|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 18 Months||16.05|0.05|0.9578
73887702|NCT03038100|147309322|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67||||0.5637|TWO_SIDED|95.0|-46.49|79.82|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|0.5637
73887703|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.6063|TWO_SIDED|95.0|0.75|1.63|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 3 Day 1||1.63|0.75|0.6063
73887704|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.9||||0.5739|TWO_SIDED|95.0|0.63|1.29|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 5 Day 1||1.29|0.63|0.5739
73887705|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.3792|TWO_SIDED|95.0|0.56|1.25|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||1.25|0.56|0.3792
73887706|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.6022|TWO_SIDED|95.0|0.73|1.73|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 12 Day 1||1.73|0.73|0.6022
73887707|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.7893|TWO_SIDED|95.0|0.59|1.49|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 16 Day 1||1.49|0.59|0.7893
73887708|NCT03038100|147309323|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2125|TWO_SIDED|95.0|0.42|1.22|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 20 Day 1||1.22|0.42|0.2125
73887709|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9661|TWO_SIDED|95.0|0.7|1.46|||Cochran-Mantel-Haenszel|||Emotional functioning, Completion of Treatment/ Early Termination Visit||1.46|0.70|0.9661
73887710|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.4299|TWO_SIDED|95.0|0.52|1.32|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 3 Months||1.32|0.52|0.4299
73887711|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.65||||0.1542|TWO_SIDED|95.0|0.36|1.18|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 6 Months||1.18|0.36|0.1542
73887712|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.65||||0.0363|TWO_SIDED|95.0|1.04|6.76|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 9 Months||6.76|1.04|0.0363
73887713|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.75||||0.0814|TWO_SIDED|95.0|0.85|8.93|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 12 Months||8.93|0.85|0.0814
73887714|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|4.03||||0.1915|TWO_SIDED|95.0|0.43|38.0|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 18 Months||38.00|0.43|0.1915
73887715|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|66.67||||0.3173|TWO_SIDED|95.0|-4.39|100.0|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 24 Months||100.00|-4.39|0.3173
73887716|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9818|TWO_SIDED|95.0|0.73|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.35|0.73|0.9818
73887717|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.6263|TWO_SIDED|95.0|0.8|1.45|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.45|0.80|0.6263
73887718|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9407|TWO_SIDED|95.0|0.73|1.4|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.40|0.73|0.9407
73887719|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.77|TWO_SIDED|95.0|0.64|1.39|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.39|0.64|0.7700
73887720|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8458|TWO_SIDED|95.0|0.63|1.45|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.45|0.63|0.8458
73887721|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.7028|TWO_SIDED|95.0|0.57|1.46|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.46|0.57|0.7028
73887722|NCT03038100|147309323|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1391|TWO_SIDED|95.0|0.92|1.83|||Cochran-Mantel-Haenszel|||Physical functioning, Completion of Treatment/ Early Termination Visit||1.83|0.92|0.1391
73887723|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.8002|TWO_SIDED|95.0|0.69|1.62|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.62|0.69|0.8002
73887724|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9751|TWO_SIDED|95.0|0.6|1.68|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.68|0.60|0.9751
73887725|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.37||||0.3811|TWO_SIDED|95.0|0.68|2.78|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||2.78|0.68|0.3811
73887726|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.51||||0.395|TWO_SIDED|95.0|0.58|3.9|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||3.90|0.58|0.3950
73887727|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.89||||0.8993|TWO_SIDED|95.0|0.16|5.12|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||5.12|0.16|0.8993
73887728|NCT03038100|147309323|SUPERIORITY|Stratified|Difference in Proportion of Responders|50.0||||0.3173|TWO_SIDED|95.0|-23.34|100.0|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 24 Months||100.00|-23.34|0.3173
73887729|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.5988|TWO_SIDED|95.0|0.68|1.25|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 3 Day 1||1.25|0.68|0.5988
73887730|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8859|TWO_SIDED|95.0|0.72|1.34|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 5 Day 1||1.34|0.72|0.8859
73887731|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.82||||0.2531|TWO_SIDED|95.0|0.58|1.16|||Cochran-Mantel-Haenszel|Stratified Analysis||Global health status/QoL, Cycle 8 Day 1||1.16|0.58|0.2531
73887732|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.69||||0.0785|TWO_SIDED|95.0|0.46|1.04|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.04|0.46|0.0785
73887733|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.67||||0.0641|TWO_SIDED|95.0|0.43|1.03|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||1.03|0.43|0.0641
73887734|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.48||||0.0046|TWO_SIDED|95.0|0.29|0.8|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||0.80|0.29|0.0046
73887735|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8928|TWO_SIDED|95.0|0.7|1.37|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/ Early Termination Visit||1.37|0.70|0.8928
73887736|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.6106|TWO_SIDED|95.0|0.72|1.74|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.74|0.72|0.6106
73887737|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.15||||0.6159|TWO_SIDED|95.0|0.67|1.95|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.95|0.67|0.6159
73887738|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.24||||0.5372|TWO_SIDED|95.0|0.62|2.49|||Cochran-Mantel-Haenszel|Stratified Analysis||Global health status/QoL, Post-Treatment Follow Up 9 Months||2.49|0.62|0.5372
73887739|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.22||||0.0845|TWO_SIDED|95.0|0.89|5.58|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||5.58|0.89|0.0845
73887740|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|3.67||||0.1344|TWO_SIDED|95.0|0.62|21.56|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||21.56|0.62|0.1344
73887741|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0||||0.3173|TWO_SIDED|95.0|-23.34|100.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 24 Months||100.00|-23.34|0.3173
73887742|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.026|TWO_SIDED|95.0|1.04|1.92|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.92|1.04|0.0260
73887743|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.9179|TWO_SIDED|95.0|0.75|1.37|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.37|0.75|0.9179
73887744|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.582|TWO_SIDED|95.0|0.79|1.53|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.53|0.79|0.5820
73887745|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9772|TWO_SIDED|95.0|0.67|1.47|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.47|0.67|0.9772
73887746|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.13|TWO_SIDED|95.0|0.49|1.1|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.10|0.49|0.1300
73887747|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.66||||0.099|TWO_SIDED|95.0|0.4|1.08|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.08|0.40|0.0990
73887748|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.7133|TWO_SIDED|95.0|0.76|1.5|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.50|0.76|0.7133
73887749|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.38||||0.1384|TWO_SIDED|95.0|0.9|2.11|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||2.11|0.90|0.1384
73887750|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.33||||0.2895|TWO_SIDED|95.0|0.78|2.26|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||2.26|0.78|0.2895
73887751|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.55||||0.2221|TWO_SIDED|95.0|0.77|3.14|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||3.14|0.77|0.2221
73887752|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|7.37||||0.0005|TWO_SIDED|95.0|2.08|26.1|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||26.10|2.08|0.0005
73887753|NCT03038100|147309323|SUPERIORITY||Odds Ratio (OR)|3.72||||0.2171|TWO_SIDED|95.0|0.4|34.56|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||34.56|0.40|0.2171
73887754|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-46.49|79.82||||||Role functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|
73887755|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.4647|TWO_SIDED|95.0|0.84|1.48|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 3 Day 1||1.48|0.84|0.4647
73887756|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.7676|TWO_SIDED|95.0|0.78|1.4|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 5 Day 1||1.40|0.78|0.7676
73887757|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.24||||0.1983|TWO_SIDED|95.0|0.89|1.71|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.71|0.89|0.1983
73887758|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9874|TWO_SIDED|95.0|0.69|1.44|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||1.44|0.69|0.9874
73887759|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.4716|TWO_SIDED|95.0|0.58|1.29|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||1.29|0.58|0.4716
73887760|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.2041|TWO_SIDED|95.0|0.46|1.18|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.18|0.46|0.2041
73887761|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7771|TWO_SIDED|95.0|0.76|1.45|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/ Early Termination Visit||1.45|0.76|0.7771
73887762|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8542|TWO_SIDED|95.0|0.64|1.45|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.45|0.64|0.8542
73887763|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.5||||0.123|TWO_SIDED|95.0|0.9|2.5|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||2.50|0.90|0.1230
73887764|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.72||||0.1089|TWO_SIDED|95.0|0.88|3.34|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||3.34|0.88|0.1089
73887765|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|5.82||||0.0011|TWO_SIDED|95.0|1.85|18.3|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||18.30|1.85|0.0011
73887766|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.51||||0.295|TWO_SIDED|95.0|0.43|14.74|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||14.74|0.43|0.2950
73887767|NCT03038100|147309323|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33|||||TWO_SIDED|95.0|-37.72|100.0||||||Social functioning, Post-Treatment Follow Up 24 Months||100.00|-37.72|
73887768|NCT02392624|147309328|SUPERIORITY||Clinical Worsening Rate Difference|-39.4|||<|0.0001|TWO_SIDED|95.0|-54.5|-22.5|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||-22.5|-54.5|<0.0001
73887769|NCT02392624|147309329|SUPERIORITY||||||<|0.0001|||||||Log Rank|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||||<0.0001
73887770|NCT02392624|147309330|SUPERIORITY||Clinical Worsening Rate Difference|-32.1||||0.0004|TWO_SIDED|95.0|-47.9|-14.9|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||-14.9|-47.9|0.0004
73887771|NCT02392624|147309331|OTHER||||||<|0.0001|||||||One-sample t-test, 1 sided|The p-value from this test was used to determine the importance of continued treatment in this study. P-value is one-sided with alpha = 0.05.||The null hypothesis for this test was that the mean change from Week 24 to Week 48 in UAS7 score was \>/=5 and the alternative hypothesis was that the mean change from Week 24 to Week 48 in UAS7 score was \<5.||||<0.0001
73887772|NCT02392624|147309332|OTHER||||||<|0.0001|||||||One-sample t-test, 2 sided|The p-value from this test was used to evaluate the importance of retreatment after experiencing clinical worsening.||The null hypothesis for this test was that the mean change from the time of retreatment to 12 weeks after retreatment in UAS7 was zero and the alternative hypothesis was that this change was non-zero.||||<0.0001
73887773|NCT03841604|147309349|SUPERIORITY||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1695|TWO_SIDED|95.0|-1.75|0.32|||Mixed Model Repeated Measures|||||0.32|-1.75|0.1695
73887774|NCT03841604|147309350|OTHER||Least square mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.55||0.0784|TWO_SIDED|95.0|-2.1|0.12|||Mixed Model Repeated Measures|||||0.12|-2.1|0.0784
73887775|NCT03841604|147309351|OTHER||Risk Difference (RD)|-0.23||||0.0744|TWO_SIDED|95.0|-0.45|-0.01|||Cochran-Mantel-Haenszel|||||-0.01|-0.45|0.0744
73887776|NCT03841604|147309352|OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7247|TWO_SIDED|95.0|-0.7|0.49|||Mixed Model Repeated Measures|||||0.49|-0.70|0.7247
73887777|NCT03841604|147309353|OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.9052|TWO_SIDED|95.0|-0.43|0.38|||Mixed Model Repeated Measures|||||0.38|-0.43|0.9052
73887778|NCT03841604|147309354|OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.7115|TWO_SIDED|95.0|-0.61|0.88|||Mixed Model Repeated Measures|||||0.88|-0.61|0.7115
73887779|NCT03841604|147309355|SUPERIORITY||Risk Difference (RD)|0.04||||0.1967|TWO_SIDED|95.0|-0.04|0.12|||Cochran-Mantel-Haenszel|||||0.12|-0.04|0.1967
73887780|NCT03841604|147309356|SUPERIORITY||Risk Difference (RD)|0.06||||0.5122|TWO_SIDED|95.0|-0.13|0.26|||Cochran-Mantel-Haenszel|||||0.26|-0.13|0.5122
73887781|NCT03841604|147309358|OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.29||0.7376|TWO_SIDED|95.0|-3.03|2.16|||ANCOVA|||||2.16|-3.03|0.7376
73887782|NCT03841604|147309359|OTHER||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|3.92||0.5349|TWO_SIDED|95.0|-10.33|5.43|||Mixed Model Repeated Measures|||||5.43|-10.33|0.5349
73887783|NCT02085161|147309406|SUPERIORITY_OR_OTHER||Treatment ratio|1.458|STANDARD_ERROR_OF_MEAN|0.147||0.0002|TWO_SIDED|95.0|1.196|1.777||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).|This treatment comparison is the first one in the alpha-protected hierarchical testing chain.||1.777|1.196|0.0002
73887784|NCT02085161|147309406|SUPERIORITY_OR_OTHER||Treatment ratio|1.292|STANDARD_ERROR_OF_MEAN|0.129||0.0109|TWO_SIDED|95.0|1.061|1.573||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the second one in the alpha-protected hierarchical testing chain.||1.573|1.061|0.0109
73887785|NCT02085161|147309406|SUPERIORITY_OR_OTHER||Treatment ratio|1.041|STANDARD_ERROR_OF_MEAN|0.106||0.6895|TWO_SIDED|95.0|0.853|1.272||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the third one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is \>0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.||1.272|0.853|0.6895
73887786|NCT02085161|147309406|SUPERIORITY_OR_OTHER||Treatment ratio|1.128|STANDARD_ERROR_OF_MEAN|0.11||0.2188|TWO_SIDED|95.0|0.931|1.368||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.|||1.368|0.931|0.2188
73887787|NCT02085161|147309406|SUPERIORITY_OR_OTHER||Treatment ratio|1.241|STANDARD_ERROR_OF_MEAN|0.123||0.0303|TWO_SIDED|95.0|1.021|1.507||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.|||1.507|1.021|0.0303
73887788|NCT02085161|147309407|SUPERIORITY_OR_OTHER||LSMean Difference|-331.975|STANDARD_ERROR_OF_MEAN|296.375||0.2639|TWO_SIDED|95.0|-916.015|252.064||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||252.064|-916.015|0.2639
73887789|NCT02085161|147309407|SUPERIORITY_OR_OTHER||LSMean Difference|161.072|STANDARD_ERROR_OF_MEAN|293.506||0.5837|TWO_SIDED|95.0|-417.314|739.459||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||739.459|-417.314|0.5837
73887790|NCT02085161|147309407|SUPERIORITY_OR_OTHER||LSMean Difference|-524.926|STANDARD_ERROR_OF_MEAN|296.802||0.0783|TWO_SIDED|95.0|-1109.806|59.954||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||59.954|-1109.806|0.0783
73887791|NCT02085161|147309407|SUPERIORITY_OR_OTHER||LSMean Difference|-493.048|STANDARD_ERROR_OF_MEAN|289.566||0.09|TWO_SIDED|95.0|-1063.67|77.575||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||77.575|-1063.670|0.0900
73887792|NCT02085161|147309407|SUPERIORITY_OR_OTHER||LSMean Difference|685.998|STANDARD_ERROR_OF_MEAN|289.435||0.0186|TWO_SIDED|95.0|115.635|1256.362||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||1256.362|115.635|0.0186
73887793|NCT02085161|147309408|SUPERIORITY_OR_OTHER||LSMean Difference|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.5186|TWO_SIDED|95.0|-0.01|0.005||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.005|-0.010|0.5186
73887794|NCT02085161|147309408|SUPERIORITY_OR_OTHER||LSMean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.004||0.6436|TWO_SIDED|95.0|-0.006|0.009||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.009|-0.006|0.6436
73887795|NCT02085161|147309408|SUPERIORITY_OR_OTHER||LSMean Difference|-0.006|STANDARD_ERROR_OF_MEAN|0.004||0.1081|TWO_SIDED|95.0|-0.014|0.001||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.001|-0.014|0.1081
73887796|NCT02085161|147309408|SUPERIORITY_OR_OTHER||LSMean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.004||0.2612|TWO_SIDED|95.0|-0.011|0.003||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.003|-0.011|0.2612
73887797|NCT02085161|147309408|SUPERIORITY_OR_OTHER||LSMean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.004||0.0361|TWO_SIDED|95.0|0.001|0.015||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.015|0.001|0.0361
73887798|NCT02085161|147309409|SUPERIORITY_OR_OTHER||LSMean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.056||0.1727|TWO_SIDED|95.0|-0.034|0.187||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.187|-0.034|0.1727
73887799|NCT02085161|147309409|SUPERIORITY_OR_OTHER||LSMean Difference|0.143|STANDARD_ERROR_OF_MEAN|0.055||0.0097|TWO_SIDED|95.0|0.035|0.252||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.252|0.035|0.0097
73887800|NCT02085161|147309409|SUPERIORITY_OR_OTHER||LSMean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.056||0.7815|TWO_SIDED|95.0|-0.095|0.126||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.126|-0.095|0.7815
73887801|NCT02085161|147309409|SUPERIORITY_OR_OTHER||LSMean Difference|-0.067|STANDARD_ERROR_OF_MEAN|0.054||0.2183|TWO_SIDED|95.0|-0.174|0.04||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.040|-0.174|0.2183
73887802|NCT02085161|147309409|SUPERIORITY_OR_OTHER||LSMean Difference|0.128|STANDARD_ERROR_OF_MEAN|0.055||0.0203|TWO_SIDED|95.0|0.02|0.236||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.236|0.020|0.0203
73887803|NCT02085161|147309410|SUPERIORITY_OR_OTHER||Treatment ratio|1.333|STANDARD_ERROR_OF_MEAN|0.142||0.0077|TWO_SIDED|95.0|1.08|1.645||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).|||1.645|1.080|0.0077
73888508|NCT05465317|147309650|OTHER||Hazard Ratio (HR)|0.8||||0.074|TWO_SIDED|95.0|0.63|1.02|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.02|0.63|0.074
73887804|NCT02085161|147309410|SUPERIORITY_OR_OTHER||Treatment ratio|1.244|STANDARD_ERROR_OF_MEAN|0.131||0.039|TWO_SIDED|95.0|1.011|1.53||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).|||1.530|1.011|0.0390
73887805|NCT02085161|147309410|SUPERIORITY_OR_OTHER||Treatment ratio|1.051|STANDARD_ERROR_OF_MEAN|0.113||0.6452|TWO_SIDED|95.0|0.85|1.299||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).|||1.299|0.850|0.6452
73887806|NCT02085161|147309410|SUPERIORITY_OR_OTHER||Treatment ratio|1.071|STANDARD_ERROR_OF_MEAN|0.111||0.5048|TWO_SIDED|95.0|0.874|1.313||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.|||1.313|0.874|0.5048
73887807|NCT02085161|147309410|SUPERIORITY_OR_OTHER||Treatment ratio|1.184|STANDARD_ERROR_OF_MEAN|0.123||0.1066|TWO_SIDED|95.0|0.964|1.453||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.|||1.453|0.964|0.1066
73887808|NCT02085161|147309411|SUPERIORITY_OR_OTHER||LSMean Difference|0.329|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.255|0.403||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.403|0.255|<0.0001
73887809|NCT02085161|147309411|SUPERIORITY_OR_OTHER||LSMean Difference|0.356|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.282|0.429||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.429|0.282|<0.0001
73887810|NCT02085161|147309411|SUPERIORITY_OR_OTHER||LSMean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.099|0.249||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.249|0.099|<0.0001
73887811|NCT02085161|147309411|SUPERIORITY_OR_OTHER||LSMean Difference|-0.027|STANDARD_ERROR_OF_MEAN|0.037||0.4677|TWO_SIDED|95.0|-0.099|0.045||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.045|-0.099|0.4677
73887812|NCT02085161|147309411|SUPERIORITY_OR_OTHER||LSMean Difference|0.182|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.109|0.255||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.255|0.109|<0.0001
73888509|NCT05465317|147309651|OTHER||Hazard Ratio (HR)|1.03||||0.46|TWO_SIDED|95.0|0.95|1.12|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.12|0.95|0.46
73887813|NCT02085161|147309412|SUPERIORITY_OR_OTHER||LSMean Difference|0.478|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|0.35|0.606||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.606|0.350|<0.0001
73887814|NCT02085161|147309412|SUPERIORITY_OR_OTHER||LSMean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|0.403|0.657||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.657|0.403|<0.0001
73887815|NCT02085161|147309412|SUPERIORITY_OR_OTHER||LSMean Difference|0.286|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.157|0.415||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.415|0.157|<0.0001
73887816|NCT02085161|147309412|SUPERIORITY_OR_OTHER||LSMean Difference|-0.052|STANDARD_ERROR_OF_MEAN|0.063||0.4107|TWO_SIDED|95.0|-0.176|0.072||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.072|-0.176|0.4107
73887817|NCT02085161|147309412|SUPERIORITY_OR_OTHER||LSMean Difference|0.244|STANDARD_ERROR_OF_MEAN|0.064||0.0002|TWO_SIDED|95.0|0.119|0.37||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.370|0.119|0.0002
73887818|NCT02085161|147309413|SUPERIORITY_OR_OTHER||LSMean Difference|0.318|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|0.179|0.457||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.457|0.179|<0.0001
73887819|NCT02085161|147309413|SUPERIORITY_OR_OTHER||LSMean Difference|0.302|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|0.165|0.439||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.439|0.165|<0.0001
73887820|NCT02085161|147309413|SUPERIORITY_OR_OTHER||LSMean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.071||0.0145|TWO_SIDED|95.0|0.035|0.314||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.314|0.035|0.0145
73887821|NCT02085161|147309413|SUPERIORITY_OR_OTHER||LSMean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.068||0.815|TWO_SIDED|95.0|-0.118|0.151||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.151|-0.118|0.8150
73887822|NCT02085161|147309413|SUPERIORITY_OR_OTHER||LSMean Difference|0.128|STANDARD_ERROR_OF_MEAN|0.069||0.0642|TWO_SIDED|95.0|-0.008|0.263||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.263|-0.008|0.0642
73887823|NCT03651479|147309431|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73888510|NCT05465317|147309651|OTHER||Hazard Ratio (HR)|1.04||||0.63|TWO_SIDED|95.0|0.9|1.2|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.20|0.90|0.63
73888511|NCT05465317|147309651|OTHER||Hazard Ratio (HR)|1.03||||0.52|TWO_SIDED|95.0|0.94|1.14|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.14|0.94|0.52
73887824|NCT02930824|147309443|SUPERIORITY|We will test the hypothesis that CYP2C19 rapid metabolizers or ultra rapid metabolizers (1 or 2 gain-of-function alleles) in the genotype-supported arm have better gastroesophageal reflux disease and symptom control than CYP2C19 rapid metabolizers or ultra rapid metabolizers in the conventional treatment group because they will have their dose increased based on their genotype.||||||0.78||||||Analysis was done of adult patients enrolled that have a CYP2C19 Rapid or Ultra-rapid metabolizer result.|t-test, 2 sided|||We will test the hypothesis that CYP2C19 rapid metabolizers or ultra rapid metabolizers (1 or 2 gain-of-function alleles) in the genotype-supported arm have better gastroesophageal reflux disease and symptom control than CYP2C19 rapid metabolizers or ultra rapid metabolizers in the conventional treatment group because they will have their dose increased based on their genotype.||||0.78
73887825|NCT02930824|147309444|SUPERIORITY|||||||0.031||||||Adjusted for baseline score, race, baseline proton pump inhibitor use, baseline histamine receptor antagonist use. A sensitivity analysis of participants only on omeprazole revealed similar findings.|Wilcoxon (Mann-Whitney)|Adjusted these end points for covariates, including the baseline score, race, and baseline medications using logistic regression||||||0.031
73887826|NCT02930824|147309445|SUPERIORITY||Hazard Ratio (HR)|2.42||||0.07|TWO_SIDED|95.0|0.9|6.3||unadjusted|Log Rank|||||6.3|0.9|0.07
73887827|NCT02930824|147309446|SUPERIORITY|||||||0.97||||||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.|Wilcoxon (Mann-Whitney)|||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.||||0.97
73887828|NCT02930824|147309447|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.||||0.83
73887829|NCT02540629|147309448|EQUIVALENCE|Chi-squared test||||||0.01|||||||Chi-squared|||||||0.01
73887830|NCT01746901|147309511|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|30.5|||<|0.0001|TWO_SIDED|95.0|24.4|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.6|24.4|<0.0001
73887831|NCT01746901|147309511|SUPERIORITY_OR_OTHER||LS Mean Difference|7.7||||0.0132|TWO_SIDED|95.0|1.6|13.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.7|1.6|0.0132
73887832|NCT01746901|147309511|SUPERIORITY_OR_OTHER||LS Mean Difference|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.4|9.3|<0.0001
73887833|NCT01746901|147309511|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9|||<|0.0001|TWO_SIDED|95.0|16.8|28.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.9|16.8|<0.0001
73887834|NCT01746901|147309511|SUPERIORITY_OR_OTHER||LS Mean Difference|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.4|9.3|<0.0001
73887835|NCT01746901|147309511|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||18.5|TWO_SIDED|95.0|12.5|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.6|12.5|18.5
73887836|NCT01746901|147309512|SUPERIORITY_OR_OTHER||LS Mean Difference|49.3|||<|0.0001|TWO_SIDED|95.0|39.2|59.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.5|39.2|<0.0001
73887837|NCT01746901|147309512|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9994|TWO_SIDED|95.0|-10.1|10.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.1|-10.1|0.9994
73887838|NCT01746901|147309512|SUPERIORITY_OR_OTHER||LS Mean Difference|22.2|||<|0.0001|TWO_SIDED|95.0|12.1|32.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.4|12.1|<0.0001
73887839|NCT01746901|147309512|SUPERIORITY_OR_OTHER||LS Mean Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.0|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.3|17.0|<0.0001
73887840|NCT01746901|147309512|SUPERIORITY_OR_OTHER||LS Mean Difference|23.0|||<|0.0001|TWO_SIDED|95.0|12.8|33.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||33.1|12.8|<0.0001
73887841|NCT01746901|147309512|SUPERIORITY_OR_OTHER||LS Mean Difference|18.2||||0.0005|TWO_SIDED|95.0|8.1|28.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.4|8.1|0.0005
73887842|NCT01746901|147309513|SUPERIORITY_OR_OTHER||LS Mean Difference|63.2|||<|0.0001|TWO_SIDED|95.0|51.5|74.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||74.9|51.5|<0.0001
73887843|NCT01746901|147309513|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.0402|TWO_SIDED|95.0|0.6|24.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.1|0.6|0.0402
73887844|NCT01746901|147309513|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|21.1|44.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||44.7|21.1|<0.0001
73887845|NCT01746901|147309513|SUPERIORITY_OR_OTHER||LS Mean Difference|42.6|||<|0.0001|TWO_SIDED|95.0|30.9|54.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||54.4|30.9|<0.0001
73887846|NCT01746901|147309513|SUPERIORITY_OR_OTHER||LS Mean Difference|32.1|||<|0.0001|TWO_SIDED|95.0|20.3|43.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.9|20.3|<0.0001
73887847|NCT01746901|147309513|SUPERIORITY_OR_OTHER||LS Mean Difference|36.3|||<|0.0001|TWO_SIDED|95.0|24.6|48.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.1|24.6|<0.0001
73887848|NCT01746901|147309514|SUPERIORITY_OR_OTHER||LS Mean Difference|108.0|||<|0.0001|TWO_SIDED|95.0|91.6|124.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||124.5|91.6|<0.0001
73887849|NCT01746901|147309514|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.4125|TWO_SIDED|95.0|-9.6|23.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.3|-9.6|0.4125
73887850|NCT01746901|147309514|SUPERIORITY_OR_OTHER||LS Mean Difference|46.1|||<|0.0001|TWO_SIDED|95.0|29.6|62.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||62.5|29.6|<0.0001
73887851|NCT01746901|147309514|SUPERIORITY_OR_OTHER||LS Mean Difference|68.8|||<|0.0001|TWO_SIDED|95.0|52.4|85.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||85.2|52.4|<0.0001
73887852|NCT01746901|147309514|SUPERIORITY_OR_OTHER||LS Mean Difference|56.7|||<|0.0001|TWO_SIDED|95.0|40.3|73.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.2|40.3|<0.0001
73887853|NCT01746901|147309514|SUPERIORITY_OR_OTHER||LS Mean Difference|52.6|||<|0.0001|TWO_SIDED|95.0|36.2|69.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||69.0|36.2|<0.0001
73887854|NCT01746901|147309515|SUPERIORITY_OR_OTHER||LS Mean Difference|32.8|||<|0.0001|TWO_SIDED|95.0|21.8|43.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.7|21.8|<0.0001
73887855|NCT01746901|147309515|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.6434|TWO_SIDED|95.0|-8.4|13.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.5|-8.4|0.6434
73887856|NCT01746901|147309515|SUPERIORITY_OR_OTHER||LS Mean Difference|9.0||||0.1072|TWO_SIDED|95.0|-2.0|20.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.0|-2.0|0.1072
73887857|NCT01746901|147309515|SUPERIORITY_OR_OTHER||LS Mean Difference|26.3|||<|0.0001|TWO_SIDED|95.0|15.4|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.3|15.4|<0.0001
73887858|NCT01746901|147309515|SUPERIORITY_OR_OTHER||LS Mean Difference|25.7|||<|0.0001|TWO_SIDED|95.0|14.7|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.6|14.7|<0.0001
73887859|NCT01746901|147309515|SUPERIORITY_OR_OTHER||LS Mean Difference|11.9||||0.0335|TWO_SIDED|95.0|0.9|22.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.9|0.9|0.0335
73887860|NCT01746901|147309516|SUPERIORITY_OR_OTHER||LS Mean Difference|35.0|||<|0.0001|TWO_SIDED|95.0|24.0|46.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.0|24.0|<0.0001
73887861|NCT01746901|147309516|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.9811|TWO_SIDED|95.0|-11.1|10.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.8|-11.1|0.9811
73887862|NCT01746901|147309516|SUPERIORITY_OR_OTHER||LS Mean Difference|9.0||||0.1083|TWO_SIDED|95.0|-2.0|19.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.9|-2.0|0.1083
73887863|NCT01746901|147309516|SUPERIORITY_OR_OTHER||LS Mean Difference|25.9|||<|0.0001|TWO_SIDED|95.0|14.9|36.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.9|14.9|<0.0001
73887864|NCT01746901|147309516|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2|||<|0.0001|TWO_SIDED|95.0|12.3|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.2|12.3|<0.0001
73887865|NCT01746901|147309516|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0408|TWO_SIDED|95.0|0.5|22.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.4|0.5|0.0408
73887866|NCT01746901|147309517|SUPERIORITY_OR_OTHER||LS Mean Difference|36.9|||<|0.0001|TWO_SIDED|95.0|25.2|48.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.7|25.2|<0.0001
73887867|NCT01746901|147309517|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2||||0.5968|TWO_SIDED|95.0|-14.9|8.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.6|-14.9|0.5968
73887868|NCT01746901|147309517|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.1471|TWO_SIDED|95.0|-3.1|20.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.4|-3.1|0.1471
73887869|NCT01746901|147309517|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5||||0.1136|TWO_SIDED|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.3|-2.3|0.1136
73887870|NCT01746901|147309517|SUPERIORITY_OR_OTHER||LS Mean Difference|22.4||||0.0002|TWO_SIDED|95.0|10.6|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.2|10.6|0.0002
73887871|NCT01746901|147309517|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5||||0.1136|TWO_SIDED|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.3|-2.3|0.1136
73887872|NCT01746901|147309519|SUPERIORITY_OR_OTHER||LS Mean Difference|28.5|||<|0.0001|TWO_SIDED|95.0|19.6|37.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.4|19.6|<0.0001
73887873|NCT01746901|147309519|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.6209|TWO_SIDED|95.0|-6.7|11.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.1|-6.7|0.6209
73887874|NCT01746901|147309519|SUPERIORITY_OR_OTHER||LS Mean Difference|7.5||||0.0997|TWO_SIDED|95.0|-1.4|16.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.3|-1.4|0.0997
73887875|NCT01746901|147309519|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2|||<|0.0001|TWO_SIDED|95.0|14.4|32.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.1|14.4|<0.0001
73887876|NCT01746901|147309519|SUPERIORITY_OR_OTHER||LS Mean Difference|16.6||||0.0003|TWO_SIDED|95.0|7.7|25.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.5|7.7|0.0003
73887877|NCT01746901|147309519|SUPERIORITY_OR_OTHER||LS Mean Difference|13.3||||0.0036|TWO_SIDED|95.0|4.4|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.2|4.4|0.0036
73887878|NCT01746901|147309520|SUPERIORITY_OR_OTHER||LS Mean Difference|29.9|||<|0.0001|TWO_SIDED|95.0|21.1|38.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.8|21.1|<0.0001
73887879|NCT01746901|147309520|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4||||0.5951|TWO_SIDED|95.0|-11.2|6.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.4|-11.2|0.5951
73887880|NCT01746901|147309520|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.0841|TWO_SIDED|95.0|-1.1|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.6|-1.1|0.0841
73887881|NCT01746901|147309520|SUPERIORITY_OR_OTHER||LS Mean Difference|19.8|||<|0.0001|TWO_SIDED|95.0|11.0|28.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.6|11.0|<0.0001
73887882|NCT01746901|147309520|SUPERIORITY_OR_OTHER||LS Mean Difference|14.5||||0.0014|TWO_SIDED|95.0|5.7|23.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.4|5.7|0.0014
73887883|NCT01746901|147309520|SUPERIORITY_OR_OTHER||LS Mean Difference|10.8||||0.0172|TWO_SIDED|95.0|1.9|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.6|1.9|0.0172
73887884|NCT01746901|147309521|SUPERIORITY_OR_OTHER||LS Mean Difference|30.4|||<|0.0001|TWO_SIDED|95.0|21.0|39.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.9|21.0|<0.0001
73887885|NCT01746901|147309521|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.9||||0.2166|TWO_SIDED|95.0|-15.4|3.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.5|-15.4|0.2166
73887886|NCT01746901|147309521|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5||||0.0777|TWO_SIDED|95.0|-1.0|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-1.0|0.0777
73887887|NCT01746901|147309521|SUPERIORITY_OR_OTHER||LS Mean Difference|16.0||||0.0011|TWO_SIDED|95.0|6.5|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.4|6.5|0.0011
73887888|NCT01746901|147309521|SUPERIORITY_OR_OTHER||LS Mean Difference|12.7||||0.0086|TWO_SIDED|95.0|3.3|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.2|3.3|0.0086
73887889|NCT01746901|147309521|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5||||0.0775|TWO_SIDED|95.0|-0.9|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-0.9|0.0775
73887890|NCT01746901|147309523|SUPERIORITY_OR_OTHER||LS Mean Difference|61.2|||<|0.0001|TWO_SIDED|95.0|48.8|73.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.6|48.8|<0.0001
73887891|NCT01746901|147309523|SUPERIORITY_OR_OTHER||LS Mean Difference|18.8||||0.0032|TWO_SIDED|95.0|6.4|31.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.2|6.4|0.0032
73887892|NCT01746901|147309523|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|20.5|<0.0001
73887893|NCT01746901|147309523|SUPERIORITY_OR_OTHER||LS Mean Difference|47.2|||<|0.0001|TWO_SIDED|95.0|34.8|59.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.6|34.8|<0.0001
73887894|NCT01746901|147309523|SUPERIORITY_OR_OTHER||LS Mean Difference|73.6|||<|0.0001|TWO_SIDED|95.0|61.1|86.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||86.0|61.1|<0.0001
73887895|NCT01746901|147309523|SUPERIORITY_OR_OTHER||LS Mean Difference|38.4|||<|0.0001|TWO_SIDED|95.0|26.0|50.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||50.8|26.0|<0.0001
73887896|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9|||<|0.0001|TWO_SIDED|95.0|36.0|51.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.8|36.0|<0.0001
73887897|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.4154|TWO_SIDED|95.0|-4.6|11.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.2|-4.6|0.4154
73887898|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8|||<|0.0001|TWO_SIDED|95.0|13.9|29.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.7|13.9|<0.0001
73887899|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|25.4|||<|0.0001|TWO_SIDED|95.0|17.5|33.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||33.3|17.5|<0.0001
73887900|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|20.2|||<|0.0001|TWO_SIDED|95.0|12.3|28.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.1|12.3|<0.0001
73887901|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|18.9|||<|0.0001|TWO_SIDED|95.0|11.0|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||26.8|11.0|<0.0001
73887902|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|114.2|||<|0.0001|TWO_SIDED|95.0|97.1|131.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||131.3|97.1|<0.0001
73887903|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.3985|TWO_SIDED|95.0|-9.8|24.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.4|-9.8|0.3985
73887904|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|55.6|||<|0.0001|TWO_SIDED|95.0|38.5|72.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.8|38.5|<0.0001
73887905|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|65.9|||<|0.0001|TWO_SIDED|95.0|48.8|83.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.0|48.8|<0.0001
73887906|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|55.6|||<|0.0001|TWO_SIDED|95.0|38.5|72.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.7|38.5|<0.0001
73887907|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|54.1|||<|0.0001|TWO_SIDED|95.0|37.0|71.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.2|37.0|<0.0001
73887908|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|302.8|||<|0.0001|TWO_SIDED|95.0|248.8|356.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||356.8|248.8|<0.0001
73887909|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|47.8||||0.0824|TWO_SIDED|95.0|-6.2|101.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||101.7|-6.2|0.0824
73887910|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|188.5|||<|0.0001|TWO_SIDED|95.0|134.6|242.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||242.5|134.6|<0.0001
73887911|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|162.0|||<|0.0001|TWO_SIDED|95.0|108.0|216.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||216.0|108.0|<0.0001
73887912|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|141.9|||<|0.0001|TWO_SIDED|95.0|87.9|195.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||195.8|87.9|<0.0001
73887913|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|135.7|||<|0.0001|TWO_SIDED|95.0|81.7|189.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||189.6|81.7|<0.0001
73887914|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|287.6|||<|0.0001|TWO_SIDED|95.0|219.1|356.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||356.1|219.1|<0.0001
73887915|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|101.4||||0.004|TWO_SIDED|95.0|32.9|169.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||169.8|32.9|0.0040
73887916|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|218.5|||<|0.0001|TWO_SIDED|95.0|150.0|287.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||287.0|150.0|<0.0001
73887917|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|170.5|||<|0.0001|TWO_SIDED|95.0|102.0|239.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||239.0|102.0|<0.0001
73887918|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|158.6|||<|0.0001|TWO_SIDED|95.0|90.1|227.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.1|90.1|<0.0001
73887919|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|152.2|||<|0.0001|TWO_SIDED|95.0|83.7|220.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||220.7|83.7|<0.0001
73887920|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|185.9||||0.0002|TWO_SIDED|95.0|90.1|281.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||281.8|90.1|0.0002
73887921|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|205.0|||<|0.0001|TWO_SIDED|95.0|109.2|300.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||300.8|109.2|<0.0001
73887922|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|221.0|||<|0.0001|TWO_SIDED|95.0|125.2|316.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||316.7|125.2|<0.0001
73887923|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|170.0||||0.0006|TWO_SIDED|95.0|74.1|265.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||265.8|74.1|0.0006
73887924|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|185.7||||0.0002|TWO_SIDED|95.0|89.9|281.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||281.5|89.9|0.0002
73887925|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|144.9||||0.0033|TWO_SIDED|95.0|49.1|240.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||240.8|49.1|0.0033
73887926|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|170.0||||0.0017|TWO_SIDED|95.0|65.2|274.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||274.9|65.2|0.0017
73887927|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|211.4||||0.0001|TWO_SIDED|95.0|106.6|316.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||316.2|106.6|0.0001
73887928|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|219.2|||<|0.0001|TWO_SIDED|95.0|114.5|324.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||324.0|114.5|<0.0001
73887929|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|162.2||||0.0027|TWO_SIDED|95.0|57.3|267.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||267.0|57.3|0.0027
73887930|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|185.9||||0.0006|TWO_SIDED|95.0|81.1|290.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||290.7|81.1|0.0006
73887931|NCT01746901|147309524|SUPERIORITY_OR_OTHER||LS Mean Difference|135.5||||0.0116|TWO_SIDED|95.0|30.7|240.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||240.4|30.7|0.0116
73887932|NCT01746901|147309525|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.3|-1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.5|-4.3|<0.0001
73887933|NCT01746901|147309525|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8||||0.0001|TWO_SIDED|95.0|1.4|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.2|1.4|0.0001
73887934|NCT01746901|147309525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7005|TWO_SIDED|95.0|-1.7|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.1|-1.7|0.7005
73887935|NCT01746901|147309525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.844|TWO_SIDED|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-1.3|0.8440
73887936|NCT01746901|147309525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.7295|TWO_SIDED|95.0|-1.6|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.1|-1.6|0.7295
73887937|NCT01746901|147309525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.8757|TWO_SIDED|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-1.3|0.8757
73887938|NCT01746901|147309526|SUPERIORITY_OR_OTHER||LS Mean Difference|60.1|||<|0.0001|TWO_SIDED|95.0|47.4|72.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.9|47.4|<0.0001
73887939|NCT01746901|147309526|SUPERIORITY_OR_OTHER||LS Mean Difference|12.6||||0.0514|TWO_SIDED|95.0|-0.1|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.4|-0.1|0.0514
73887940|NCT01746901|147309526|SUPERIORITY_OR_OTHER||LS Mean Difference|29.7|||<|0.0001|TWO_SIDED|95.0|17.0|42.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||42.4|17.0|<0.0001
73887941|NCT01746901|147309526|SUPERIORITY_OR_OTHER||LS Mean Difference|43.0|||<|0.0001|TWO_SIDED|95.0|30.3|55.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||55.8|30.3|<0.0001
73887942|NCT01746901|147309526|SUPERIORITY_OR_OTHER||LS Mean Difference|33.7|||<|0.0001|TWO_SIDED|95.0|21.0|46.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.4|21.0|<0.0001
73887943|NCT01746901|147309526|SUPERIORITY_OR_OTHER||LS Mean Difference|36.4|||<|0.0001|TWO_SIDED|95.0|23.7|49.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.1|23.7|<0.0001
73887944|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|39.5|||<|0.0001|TWO_SIDED|95.0|31.8|47.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||47.2|31.8|<0.0001
73887945|NCT01746901|147309527|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.2739|TWO_SIDED|95.0|-3.4|12.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.0|-3.4|0.2739
73888584|NCT02864394|147309779|OTHER||Hazard Ratio (HR)|0.75||||0.0076|TWO_SIDED|95.0|0.6|0.95|||Log Rank|||OS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%). A nominal one-sided p-value for testing was based on log-rank test stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%).||0.95|0.60|0.0076
73888585|NCT02864394|147309780|OTHER||Hazard Ratio (HR)|0.76||||0.0534|TWO_SIDED|95.0|0.54|1.07|||Log Rank|||PFS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate. A nominal one-sided p-value for testing was based on log-rank test.||1.07|0.54|0.0534
73888586|NCT02864394|147309781|OTHER||Hazard Ratio (HR)|0.84||||0.0847|TWO_SIDED|95.0|0.66|1.08|||Log Rank|||PFS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%). A nominal one-sided p-value for testing was based on log-rank test stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%).||1.08|0.66|0.0847
73888587|NCT02864394|147309782|OTHER||Difference in Percentage|21.0|||<|0.0001|TWO_SIDED|95.0|11.5|30.7|||Miettinen & Nurminen Method|||ORR was not formally tested. Treatment comparison was based on the Miettinen \& Nurminen method. A nominal one-sided p-value for testing was calculated.||30.7|11.5|<0.0001
73888588|NCT02864394|147309783|OTHER||Difference in Percentage|15.0|||<|0.0001|TWO_SIDED|95.0|8.8|21.6|||Miettinen & Nurminen Method|||ORR was not formally tested. Treatment comparison was based on Miettinen \& Nurminen method stratified by PD-L1 expression status (TPS\>=50% vs. TPS 1-49%). If no participants were in one of the treatment arms involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison. A nominal one-sided p-value for testing was calculated.||21.6|8.8|<0.0001
73888589|NCT00554216|147309810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.36|STANDARD_ERROR_OF_MEAN|0.476|<|0.0001|TWO_SIDED|95.0|8.43|10.3||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||10.30|8.43|<0.0001
73888590|NCT00554216|147309810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|0.596|<|0.0001|TWO_SIDED|95.0|2.38|4.71||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.71|2.38|<0.0001
73888591|NCT00554216|147309810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.82|STANDARD_ERROR_OF_MEAN|0.596|<|0.0001|TWO_SIDED|95.0|4.65|6.99||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||6.99|4.65|<0.0001
73888592|NCT00554216|147309811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.61|STANDARD_ERROR_OF_MEAN|1.463|<|0.0001|TWO_SIDED|95.0|7.13|12.95||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||12.95|7.13|<0.0001
73888593|NCT00554216|147309811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|2.8|5.63||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||5.63|2.80|<0.0001
73888594|NCT00554216|147309811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|STANDARD_ERROR_OF_MEAN|0.394|<|0.0001|TWO_SIDED|95.0|1.76|3.33||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.33|1.76|<0.0001
73888595|NCT02494323|147309819|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value is adjusted for the comparison of subjects who benefited, were satisfied and willing to continue using the Segmented Electrodes versus subjects who didn't benefit, wern't satisfied ans were not willing to continue using the Segmented Eletrode|t-test, 1 sided|||||||<0.01
73888596|NCT01524796|147309820|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||paired Wilcoxon signed-rank test|||||||<0.001
73888597|NCT01524796|147309821|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
73888598|NCT01524796|147309822|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
73888599|NCT00956007|147309835|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0747|TWO_SIDED|95.0|0.6|1.08||One-sided significance level = 0.0183|Log Rank|Stratified by EGFR and site/p16 status|Stratified by EGFR and site/p16 status. Reference level = IMRT.|This trial was designed to detect a hazard ratio (HR) of 0.74 with 80% statistical power and overall one-sided alpha of 0.025 (372 deaths) using a stratified log-rank test, assuming a control arm 3-year survival rate of 60.1%. The amended protocol based on ≥ 5 years potential follow-up projected 169 events, providing 55%, 66%, and 79% power to detect HRs of 0.71, 0.68, and 0.64, respectively, using the original one-sided alpha of 0.0183 the final analysis.||1.08|0.60|0.0747
73888600|NCT00956007|147309836|SUPERIORITY|||||||0.0075|||||||Fisher Exact|||Dysphagia||||0.0075
73888601|NCT00956007|147309836|SUPERIORITY|||||||0.2955|||||||Fisher Exact|||Dry mouth||||0.2955
73888602|NCT00956007|147309836|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||Dermatitis radiation||||0.0001
73888603|NCT00956007|147309836|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Rach acneiform||||<0.0001
73888604|NCT00956007|147309837|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73888605|NCT00956007|147309838|SUPERIORITY|||||||0.1641|||||||Fisher Exact|||Dysphagia||||0.1641
73888606|NCT00956007|147309838|SUPERIORITY|||||||0.2623|||||||Fisher Exact|||Dry mouth||||0.2623
73888607|NCT00956007|147309838|SUPERIORITY|||||||0.5378|||||||Fisher Exact|||Dermatitis radiation||||0.5378
73888608|NCT00956007|147309838|SUPERIORITY|||||||0.057|||||||Fisher Exact|||Rash acneiform||||0.0570
73888609|NCT00956007|147309839|SUPERIORITY|||||||0.1575|||||||Fisher Exact|||||||0.1575
73888610|NCT00956007|147309840|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0168|TWO_SIDED|95.0|0.57|0.98||One-sided|Log Rank|Stratified by EGFR and site/p16 status|Stratified by EGFR and site/p16 status. Reference level = IMRT.|||0.98|0.57|0.0168
73888611|NCT03060096|147309878|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
73888612|NCT03060096|147309879|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
73888613|NCT03060096|147309880|OTHER||Rate|0.764|||||ONE_SIDED|95.0|0.6783||||||||||0.6783|
73888614|NCT01055197|147309916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.2103|TWO_SIDED|95.0|0.82|2.53|||Log Rank|||The null hypothesis (H0) was that PCI + RT is not effective versus the alternative hypothesis (H1) that PCI + RT is effective. Assumptions were that PCI alone would have hazard rate λc of 1.204 and PCI + RT a hazard rate λc of 0.799 (hazard ratio λt/λc = 0.663). At each planned analysis, the p-value from the log-rank test statistic assessing overall survival was compared to the nominal significance level. The final targeted accrual was 154.||2.53|0.82|0.2103
73888615|NCT01055197|147309917|SUPERIORITY|||||||0.24|||||||Fisher Exact|2-sided significance level of 0.05||||||0.24
73888616|NCT01055197|147309919|SUPERIORITY|||||||0.0102|||||||Log Rank|2-sided significance level of 0.05||||||0.0102
73897301|NCT00492063|147327653|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.07|||||TWO_SIDED|95.0|0.9|1.28||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.||1.28|0.9|
73888617|NCT00538902|147309921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.026||95.0|1.09|4.39||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.||4.39|1.09|0.026
73888618|NCT00538902|147309921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.004||95.0|1.35|5.3||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.||5.30|1.35|0.004
73888619|NCT00538902|147309922|SUPERIORITY_OR_OTHER|||||||0.009||||||The between-treatment comparison between each adalimumab group vs. placebo was performed at the 2-sided alpha = 0.05 significance level, without using a stepwise testing procedure or alpha adjustment.|Cochran-Mantel-Haenszel|Percentage ACR responders at Week 12 were compared between adalimumab and placebo groups, where missing ACR responses were imputed as non-responder.||||||0.009
73888620|NCT00538902|147309922|SUPERIORITY_OR_OTHER|||||||0.121|||||||Cochran-Mantel-Haenszel|||||||0.121
73888621|NCT03739203|147309938|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.88||0.6798|TWO_SIDED|95.0|-2.1|1.37||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||1.37|-2.10|0.6798
73888622|NCT03739203|147309938|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.89||0.1245|TWO_SIDED|95.0|-3.11|0.38||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.38|-3.11|0.1245
73888623|NCT03739203|147309939|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.5152|TWO_SIDED|95.0|-0.29|0.15||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.15|-0.29|0.5152
73888624|NCT03739203|147309939|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0573|TWO_SIDED|95.0|-0.43|0.01||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.01|-0.43|0.0573
73897302|NCT00492063|147327653|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.||0.99|0.72|
73897303|NCT00492063|147327653|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.14|||||TWO_SIDED|95.0|0.99|1.3||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.||1.3|0.99|
73897304|NCT00492063|147327653|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.96|||||TWO_SIDED|95.0|0.82|1.12||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.||1.12|0.82|
73897305|NCT00492063|147327653|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.87|||||TWO_SIDED|95.0|0.74|1.02||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.||1.02|0.74|
73888625|NCT01967940|147309940|SUPERIORITY|Enrollment into this study was stopped early due to the challenge of recruiting a sufficient number of participants who met the eligibility criteria. The actual number of enrolled is 55, among them 43 enrolled in the Randomized Cohort. Based on the actual enrollment numbers, the power to detect a 35% difference drops to 51%, under the same assumptions in the original sample size calculations.|Difference in proportions|60.7|||<|0.001|TWO_SIDED|95.0|42.6|78.8|||Fisher Exact||The 95% confidence interval was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.|A sample size of 90 participants, randomized in a 2:1 ratio, achieves 89% power to detect a 35% difference in the proportion of participants with HIV-1 RNA decreases from baseline exceeding 0.5 log10 between the TAF and placebo arms at Day 10. Sample size and power computation was based on the assumption that 50% of participants in the TAF arm and 15% of participants in the placebo arm achieved a reduction exceeding 0.5 log10 HIV-1 RNA.||78.8|42.6|<0.001
73888626|NCT04266717|147309992|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
73888627|NCT00940771|147309993|OTHER|Friedman's Test|Chi Square|12.3||||0.006|TWO_SIDED||||||Friedman's Test|3 degrees of freedom.||||||.006
73888628|NCT00940771|147309993|OTHER|Post Hoc testing Post hoc Wilcoxon Signed Rank tests||||||0.007|||||||Wilcoxon Signed Rank|Z=-2.701||Nul lHypothesis that there is no difference between specific time points.||||.007
73888629|NCT00940771|147309994|OTHER|Friedman's test with 3 df||||||0.356|||||||Friedman's Test|3 degrees of freedom||||||.356
73888630|NCT00940771|147309995|OTHER||Chi-square|1.0||||0.801|TWO_SIDED||||||Friedman's test|3 degrees of freedom|1.0 is the actual calculated Chi-X value, not the p value.|The null hypothesis was that there was a difference. We were looking for no difference between before and after switch.||||.801
73888631|NCT00940771|147309996|OTHER|Friedman's test||||||0.075||||||a priori threshold for statistical significance 0.05|Friedman's test|3 degrees of freedom||||||.075
73888632|NCT02072668|147310000|SUPERIORITY|||||||0.6281|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.6281
73888633|NCT02072668|147310001|SUPERIORITY|||||||0.7973|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.7973
73888634|NCT02072668|147310002|SUPERIORITY|||||||0.4442|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4442
73888635|NCT02072668|147310003|SUPERIORITY|||||||0.2545|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.2545
73888636|NCT02072668|147310009|SUPERIORITY|||||||0.4374|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4374
73888637|NCT02072668|147310010|SUPERIORITY|||||||0.347|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.3470
73888638|NCT02072668|147310011|SUPERIORITY|||||||0.0755|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0755
73888639|NCT02072668|147310013|SUPERIORITY|||||||0.0708|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0708
73888640|NCT02072668|147310014|SUPERIORITY|||||||0.4501|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4501
73888641|NCT02072668|147310015|SUPERIORITY|||||||0.0767|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0767
73888642|NCT02072668|147310016|SUPERIORITY|||||||0.725|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.7250
73888643|NCT00935584|147310088|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||>0.05
73888644|NCT00935584|147310088|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||>0.05
73888645|NCT00935584|147310089|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||>0.05
73888646|NCT00935584|147310089|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wicoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||>0.05
73888647|NCT00935584|147310090|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.||||>0.05
73888648|NCT00935584|147310090|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.||||>0.05
73888649|NCT00935584|147310091|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
73888650|NCT00935584|147310091|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
73888651|NCT00935584|147310092|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||<0.05
73888652|NCT00935584|147310092|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||<0.05
73888653|NCT00935584|147310093|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
73888654|NCT00935584|147310093|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
73888655|NCT03863080|147310140|SUPERIORITY||Least square mean difference|-56.33|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of Total IgG levels has been presented.|||||<0.0001
73888656|NCT03863080|147310140|SUPERIORITY||Least square mean difference|-74.49|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of Total IgG levels has been presented.|||||<0.0001
73888657|NCT03863080|147310141|SUPERIORITY||Least square mean difference|-62.7|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 1 subclass has been presented.|||||<0.001
73888658|NCT03863080|147310141|SUPERIORITY||Least square mean difference|-73.0|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 1 subclass has been presented.|||||<0.001
73888659|NCT03863080|147310141|SUPERIORITY||Least square mean difference|-52.5|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 2 subclass has been presented.|||||<0.001
73888660|NCT03863080|147310141|SUPERIORITY||Least square mean difference|-61.4|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 2 subclass has been presented.|||||<0.001
73888661|NCT03863080|147310141|SUPERIORITY||Least square mean difference|-66.1|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 3 subclass has been presented.|||||<0.001
73888662|NCT03863080|147310141|SUPERIORITY||Least square mean difference|-80.8|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 3 subclass has been presented.|||||<0.001
73888663|NCT03863080|147310141|SUPERIORITY||Least square mean difference|-44.9|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 4 subclass has been presented.|||||<0.001
73888664|NCT03863080|147310141|SUPERIORITY||Least square mean difference|-61.6|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 4 subclass has been presented.|||||<0.001
73888665|NCT03863080|147310142|SUPERIORITY||Least square mean difference|-62.58||||0.0009|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of Anti-AChR-IgG has been presented.|||||0.0009
73888666|NCT03863080|147310142|SUPERIORITY||Least square mean difference|-101.2|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of Anti-AChR-IgG has been presented.|||||<0.0001
73888667|NCT01342211|147310158|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-5.63|STANDARD_ERROR_OF_MEAN|9.759||0.5661|TWO_SIDED|95.0|-25.09|13.83|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||13.83|-25.09|0.5661
73888668|NCT01342211|147310158|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|9.422||0.808|TWO_SIDED|95.0|-21.08|16.49|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||16.49|-21.08|0.8080
73888669|NCT01342211|147310158|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.72|STANDARD_ERROR_OF_MEAN|9.404||0.0001|TWO_SIDED|95.0|-56.47|-18.97|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||-18.97|-56.47|0.0001
73888670|NCT01342211|147310158|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.11|STANDARD_ERROR_OF_MEAN|9.514|<|0.0001|TWO_SIDED|95.0|-68.08|-30.14|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||-30.14|-68.08|<0.0001
73888671|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.172||||0.8998|TWO_SIDED|95.0|0.1|13.92|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||13.92|0.10|0.8998
73888672|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.063||||0.5273|TWO_SIDED|95.0|0.22|19.48|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||19.48|0.22|0.5273
73888673|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.924||||0.0004|TWO_SIDED|95.0|5.93|490.67|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||490.67|5.93|0.0004
73888674|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|280.366|||<|0.0001|TWO_SIDED|95.0|18.65|4214.35|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||4214.35|18.65|<0.0001
73888675|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.262||||0.086|TWO_SIDED|95.0|0.06|1.21|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||1.21|0.06|0.0860
73888676|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.4308|TWO_SIDED|95.0|0.15|2.25|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||2.25|0.15|0.4308
73888677|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.272||||0.0127|TWO_SIDED|95.0|1.57|43.56|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||43.56|1.57|0.0127
73888678|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.528||||0.0096|TWO_SIDED|95.0|1.89|97.0|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||97.00|1.89|0.0096
73888679|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||0.9519|TWO_SIDED|95.0|0.02|61.54|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||61.54|0.02|0.9519
73888680|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.069||||0.974|TWO_SIDED|95.0|0.02|58.0|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||58.00|0.02|0.9740
73888681|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.286||||0.0273|TWO_SIDED|95.0|1.46|549.78|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||549.78|1.46|0.0273
73888682|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|114.508||||0.0022|TWO_SIDED|95.0|5.5|2384.03|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||2384.03|5.50|0.0022
73888683|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.216||||0.0684|TWO_SIDED|95.0|0.04|1.12|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||1.12|0.04|0.0684
73888684|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.081||||0.9068|TWO_SIDED|95.0|0.29|3.99|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||3.99|0.29|0.9068
73888685|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.251||||0.2235|TWO_SIDED|95.0|0.61|8.31|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||8.31|0.61|0.2235
73888686|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.25||||0.012|TWO_SIDED|95.0|1.59|42.82|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||42.82|1.59|0.0120
73888687|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.359||||0.5449|TWO_SIDED|95.0|0.01|9.92|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||9.92|0.01|0.5449
73888688|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.914||||0.5585|TWO_SIDED|95.0|0.22|16.85|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||16.85|0.22|0.5585
73888689|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.059||||0.0022|TWO_SIDED|95.0|3.0|147.65|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||147.65|3.00|0.0022
73888690|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.851||||0.002|TWO_SIDED|95.0|3.15|165.99|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||165.99|3.15|0.0020
73888691|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.375|TWO_SIDED|95.0|0.48|7.12|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||7.12|0.48|0.3750
73888692|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078||||0.914|TWO_SIDED|95.0|0.28|4.23|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||4.23|0.28|0.9140
73888693|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.548||||0.0036|TWO_SIDED|95.0|2.09|43.57|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||43.57|2.09|0.0036
73888694|NCT01342211|147310159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.093||||0.0149|TWO_SIDED|95.0|1.42|26.1|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||26.10|1.42|0.0149
73888695|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.674||||0.5436|TWO_SIDED|95.0|0.32|8.83|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||8.83|0.32|0.5436
73888696|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.734||||0.742|TWO_SIDED|95.0|0.12|4.63|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||4.63|0.12|0.7420
73888697|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.151||||0.0002|TWO_SIDED|95.0|4.73|167.62|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||167.62|4.73|0.0002
73888698|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.214||||0.0001|TWO_SIDED|95.0|7.88|643.42|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||643.42|7.88|0.0001
73888699|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.203||||0.321|TWO_SIDED|95.0|0.01|4.74|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||4.74|0.01|0.3210
73888700|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.175||||0.3786|TWO_SIDED|95.0|0.39|12.27|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||12.27|0.39|0.3786
73888701|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.576||||0.0144|TWO_SIDED|95.0|1.5|38.38|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||38.38|1.50|0.0144
73888702|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.465||||0.0007|TWO_SIDED|95.0|3.59|116.6|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||116.60|3.59|0.0007
73888703|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.161||||0.8626|TWO_SIDED|95.0|0.21|6.3|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||6.30|0.21|0.8626
73888704|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.497||||0.6237|TWO_SIDED|95.0|0.3|7.51|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||7.51|0.30|0.6237
73888705|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.029||||0.0072|TWO_SIDED|95.0|1.76|36.65|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||36.65|1.76|0.0072
73888706|NCT01342211|147310160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.557||||0.0005|TWO_SIDED|95.0|3.73|113.2|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||113.20|3.73|0.0005
73888707|NCT06482125|147310175|SUPERIORITY||Odds Ratio (OR)|40.955||||0.001|TWO_SIDED|95.0|14.098|118.972|||Chi-squared, Corrected|||||118.972|14.098|0.001
73888708|NCT06482125|147310176|EQUIVALENCE|The threshold for statistical significance is p \< 0.05||||||0.345|||||||Wilcoxon (Mann-Whitney)|||||||0.345
73888709|NCT06482125|147310177|EQUIVALENCE|The threshold for statistical significance is p \< 0.05||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.450
73888710|NCT06482125|147310178|EQUIVALENCE|Reject H0 = the means are equivalent|Median Difference (Net)|1.0||||0.356|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.356
73888711|NCT06482125|147310179|EQUIVALENCE|Reject H0 = the means are equivalent|Mean Difference (Final Values)|8.202||||0.07|TWO_SIDED|95.0|2.31|14.095|||t-test, 2 sided|||||14.095|2.310|0.07
73888712|NCT04701762|147310230|SUPERIORITY||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|99.32|0.14|0.29|||GLM cumulative logit GEE model|||||0.29|0.14|<0.001
73888713|NCT04701762|147310231|SUPERIORITY||Risk Ratio (RR)|0.06|||<|0.001|TWO_SIDED|99.32|0.03|0.14|||Wilcoxon (Mann-Whitney)|||||0.14|0.03|<0.001
73888714|NCT04701762|147310232|SUPERIORITY||Risk Ratio (RR)|0.87||||0.53|TWO_SIDED|99.32|0.48|1.58|||GLM log-binomial model (log link)|||||1.58|0.48|0.53
73888715|NCT04701762|147310233|SUPERIORITY||Mean Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|95.0|0.92|3.1|||Mixed Models Analysis|||||3.1|0.92|<0.001
73888716|NCT04701762|147310234|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.27|TWO_SIDED|95.0|-0.34|1.2|||Mixed Models Analysis|||||1.2|-0.34|0.27
73888717|NCT05786651|147310241|EQUIVALENCE|Comparison of conditions|||||<|0.05|||||||ANOVA|||||||<.05
73888718|NCT05786651|147310242|EQUIVALENCE|Comparisons of mean values of conditions|||||<|0.05|||||||ANOVA|||||||<.05
73888719|NCT04390763|147310248|OTHER||Hazard Ratio (HR)|0.7|||||ONE_SIDED|90.0||1.04|||Bayesian two-piece hazard model||Estimated posterior median of the HR after the risk changing timepoint and one-sided 90% credible interval are reported.|||1.04||
73888720|NCT04390763|147310248|OTHER||Hazard Ratio (HR)|1.41|||||ONE_SIDED|90.0||1.96|||Bayesian two-piece hazard model||Estimated posterior median of the HR after the risk changing timepoint and one-sided 90% credible interval are reported.|||1.96||
73888721|NCT04390763|147310249|OTHER||Hazard Ratio (HR)|1.02||||0.46|ONE_SIDED|90.0||1.37|||Regression, Cox|||||1.37||0.46
73888722|NCT04390763|147310249|OTHER||Hazard Ratio (HR)|1.08||||0.38|ONE_SIDED|90.0||1.44|||Regression, Cox|||||1.44||0.38
73888723|NCT03397966|147310297|SUPERIORITY|||||||0.063||||||The investigators tested the effect of treatment (BNP vs. control) on the primary endpoint using mixed effects modeling, adjusting for treatment sequence, to assess the effect of treatment on each endpoint.|Mixed Models Analysis|||The primary endpoint is change in resting energy expenditure, calculated as final resting energy expenditure adjusted for baseline level, using linear regression. The null hypothesis is that there will be no significant effect of treatment on each endpoint. The investigators adhered to intention-to-treat principles. The test was performed with a significance level of 0.05.||||0.063
73888724|NCT03397966|147310298|SUPERIORITY|||||||0.07||||||Paired t-test.|t-test, 2 sided|||The null hypothesis is that there will be no significant effect of BNP on adipose gene expression of UCP1 compared with placebo. The alternative hypothesis is that UCP1 expression would be significantly higher after BNP treatment compared with placebo.||||0.07
73888725|NCT03077412|147310347|SUPERIORITY||Risk Difference in Percentages|22.1|||||TWO_SIDED|90.0|-9.9|50.0|||||The 90% exact confidence interval (CI) was calculated based on binomial distribution (Clopper-Pearson method).|||50.0|-9.9|
73888726|NCT03077412|147310347|SUPERIORITY||Risk Difference in Percentages|4.2|||||TWO_SIDED|90.0|-26.5|34.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||34.3|-26.5|
73888727|NCT03077412|147310348|SUPERIORITY||Risk Difference in Percentages|30.4|||||TWO_SIDED|90.0|-1.3|57.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||57.3|-1.3|
73888728|NCT03077412|147310348|SUPERIORITY||Risk Difference in Percentages|8.3|||||TWO_SIDED|90.0|-22.5|38.1|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||38.1|-22.5|
73888729|NCT03077412|147310349|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|90.0|0.64|2.49|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||2.49|0.64|
73888730|NCT03077412|147310349|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|90.0|0.47|1.75|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||1.75|0.47|
73888731|NCT03077412|147310350|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|90.0|0.87|4.01|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||4.01|0.87|
73888732|NCT03077412|147310350|SUPERIORITY||Hazard Ratio (HR)|1.37|||||TWO_SIDED|90.0|0.65|2.92|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||2.92|0.65|
73888733|NCT03077412|147310351|SUPERIORITY||Risk Difference in Percentages|-18.6|||||TWO_SIDED|90.0|-55.6|21.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||21.3|-55.6|
73888734|NCT03077412|147310351|SUPERIORITY||Risk Difference in Percentages|-13.2|||||TWO_SIDED|90.0|-51.0|24.1|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||24.1|-51.0|
73888735|NCT02266888|147310352|SUPERIORITY||Hazard Ratio (HR)|0.673||||0.514|TWO_SIDED|90.0|0.248|1.826|||Regression, Cox||Hazard ratio estimated for Rituximab vs. Placebo|||1.826|0.248|0.514
73888736|NCT02266888|147310356|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
73888737|NCT02266888|147310357|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
73888738|NCT02266888|147310358|SUPERIORITY|||||||0.188|||||||Fisher Exact|||||||0.188
73888739|NCT02266888|147310361|SUPERIORITY||Mean Difference (Net)|-1.62||||0.015|TWO_SIDED|90.0|-2.64|-0.6|||Paired t-Test|||This is not a comparison between treatment groups, but rather a comparison between timepoints.The Rituximab and Placebo groups were combined for purposes of testing the hypothesis that there would be no change in SD between pre-enrollment and 180 days post-enrollment into the TVI.||-0.60|-2.64|0.015
73888740|NCT02266888|147310363|SUPERIORITY|||||||0.502|||||||Cochran-Mantel-Haenszel|||||||0.502
73888741|NCT02266888|147310364|SUPERIORITY|||||||0.448|||||||Fisher Exact|||||||0.448
73888742|NCT03762993|147310388|OTHER|Changes in phonation threshold pressure were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.|||||<|0.001||||||P-value is for the effect of time. A priori significance level set at .05|Mixed Models Analysis|||||||<0.001
73888743|NCT03762993|147310389|OTHER|Changes in lung volumes were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.|||||<|0.01||||||P-value represents effect of group. A priori threshold for significance set at .05|Mixed Models Analysis|||||||<0.01
73888744|NCT01193244|147310390|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.707|||<|1e-05||95.0|0.626|0.799|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (\<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at Baseline.||0.799|0.626|<0.00001
73888745|NCT01193244|147310391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.59755||95.0|0.838|1.107|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio \<1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.||1.107|0.838|0.59755
73888746|NCT01193244|147310392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.166|||<|0.001||95.0|1.724|2.721|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline Eastern Cooperative Oncology Group (ECOG) score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio greater than (\>)1 favored orteronel. P-values tested for odds ratio equal to 1.||2.721|1.724|<0.001
73888747|NCT01193244|147310393|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.712||||0.001||95.0|1.235|2.373|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline ECOG score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio \> 1 favored orteronel. P-values tested for odds ratio equal to 1.||2.373|1.235|0.001
73888748|NCT01193244|147310394|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.885||||0.33906||95.0|0.688|1.138|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (\<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.||1.138|0.688|0.33906
73888749|NCT03763877|147310425|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|7.926||0.9883|TWO_SIDED|95.0|-15.42|15.66|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||15.66|-15.42|0.9883
73888750|NCT03763877|147310425|SUPERIORITY||Mean Difference (Final Values)|-13.14|STANDARD_ERROR_OF_MEAN|7.609||0.0842|TWO_SIDED|95.0|-28.06|1.78|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.78|-28.06|0.0842
73888751|NCT03763877|147310425|SUPERIORITY||Mean Difference (Final Values)|-13.54|STANDARD_ERROR_OF_MEAN|7.636||0.0763|TWO_SIDED|95.0|-28.51|1.43|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.43|-28.51|0.0763
73888752|NCT03763877|147310426|SUPERIORITY||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|7.265||0.8283|TWO_SIDED|95.0|-16.01|12.85|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||12.85|-16.01|0.8283
73888753|NCT03763877|147310426|SUPERIORITY||Mean Difference (Final Values)|-13.25|STANDARD_ERROR_OF_MEAN|7.221||0.0698|TWO_SIDED|95.0|-27.6|1.1|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.10|-27.60|0.0698
73888754|NCT03763877|147310426|SUPERIORITY||Mean Difference (Final Values)|-17.31|STANDARD_ERROR_OF_MEAN|7.207||0.0184|TWO_SIDED|95.0|-31.63|-2.99|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||-2.99|-31.63|0.0184
73888755|NCT03763877|147310427|SUPERIORITY||Location Shift|-4.22||||0.5537|TWO_SIDED|95.0|-15.64|8.65|||Wilcoxon (Mann-Whitney)|||||8.65|-15.64|0.5537
73888756|NCT03763877|147310427|SUPERIORITY||Location Shift|-13.64||||0.1005|TWO_SIDED|95.0|-26.19|1.88|||Wilcoxon (Mann-Whitney)|||||1.88|-26.19|0.1005
73888757|NCT03763877|147310427|SUPERIORITY||Location Shift|-18.72||||0.0387|TWO_SIDED|95.0|-31.95|-1.58|||Wilcoxon (Mann-Whitney)|||||-1.58|-31.95|0.0387
73888758|NCT03763877|147310428|SUPERIORITY||Mean Difference (Final Values)|7.25|STANDARD_ERROR_OF_MEAN|0.5733||0.5733|TWO_SIDED|95.0|-18.0|32.51|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||32.51|-18.00|0.5733
73888759|NCT03763877|147310428|SUPERIORITY||Mean Difference (Final Values)|-10.61|STANDARD_ERROR_OF_MEAN|12.236||0.3861|TWO_SIDED|95.0|-34.6|13.38|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||13.38|-34.60|0.3861
73888760|NCT03763877|147310428|SUPERIORITY||Mean Difference (Final Values)|-21.13|STANDARD_ERROR_OF_MEAN|12.916||0.1019|TWO_SIDED|95.0|-46.46|4.19|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||4.19|-46.46|0.1019
73888761|NCT03763877|147310429|SUPERIORITY||Mean Difference (Final Values)|-0.242|STANDARD_ERROR_OF_MEAN|1.3873||0.8617|TWO_SIDED|95.0|-2.961|2.478|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||2.478|-2.961|0.8617
73888762|NCT03763877|147310429|SUPERIORITY||Mean Difference (Final Values)|-2.571|STANDARD_ERROR_OF_MEAN|1.3712||0.0609|TWO_SIDED|95.0|-5.26|0.117|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method|||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|0.117|-5.260|0.0609
73888763|NCT03763877|147310429|SUPERIORITY||Mean Difference (Final Values)|-2.414|STANDARD_ERROR_OF_MEAN|1.3633||0.0766|TWO_SIDED|95.0|-5.087|0.258|||ANCOVA|ANCOVA using a multiple imputation procedure based on the fully conditional specification method|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.258|-5.087|0.0766
73888764|NCT03763877|147310430|SUPERIORITY||Odds Ratio (OR)|1.744||||0.5592|TWO_SIDED|95.0|0.27|11.267|||Regression, Logistic|Logistic regression with multiple imputation||||11.267|0.270|0.5592
73888765|NCT03763877|147310430|SUPERIORITY||Odds Ratio (OR)|2.287||||0.3747|TWO_SIDED|95.0|0.368|14.208|||Regression, Logistic|Logistic regression with multiple imputation||||14.208|0.368|0.3747
73888766|NCT03763877|147310430|SUPERIORITY||Odds Ratio (OR)|5.669||||0.0501|TWO_SIDED|95.0|1.0|32.149|||Regression, Logistic|Logistic regression with multiple imputation||||32.149|1.000|0.0501
73888767|NCT03763877|147310431|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|3.71||0.8013|TWO_SIDED|95.0|-8.3|6.4|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||6.4|-8.3|0.8013
73888768|NCT03763877|147310431|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|3.81||0.8694|TWO_SIDED|95.0|-8.2|7.0|||Mixed Models Analysis|Mixed Model Repeated Measures|||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|7.0|-8.2|0.8694
73888769|NCT03763877|147310431|SUPERIORITY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|3.8||0.0581|TWO_SIDED|95.0|-14.9|0.3|||Mixed Models Analysis|Mixed Model Repeated Measures|||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|0.3|-14.9|0.0581
73888770|NCT03763877|147310432|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|2.44||0.6681|TWO_SIDED|95.0|-3.8|5.9|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.9|-3.8|0.6681
73888771|NCT03763877|147310432|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|2.51||0.8224|TWO_SIDED|95.0|-4.4|5.5|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.5|-4.4|0.8224
73888772|NCT03763877|147310432|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|2.5||0.0924|TWO_SIDED|95.0|-9.2|0.7|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7|-9.2|0.0924
73888773|NCT03763877|147310433|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.256||0.5148|TWO_SIDED|95.0|-0.68|0.34|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.34|-0.68|0.5148
73888774|NCT03763877|147310433|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.261||0.0434|TWO_SIDED|95.0|-1.05|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.02|-1.05|0.0434
73888775|NCT03763877|147310433|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.261||0.0494|TWO_SIDED|95.0|-1.04|0.0|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.00|-1.04|0.0494
73888776|NCT03763877|147310434|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.111||0.2449|TWO_SIDED|95.0|-0.35|0.09|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.09|-0.35|0.2449
73888777|NCT03763877|147310434|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.115||0.0502|TWO_SIDED|95.0|-0.46|0.0|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.00|-0.46|0.0502
73888778|NCT03763877|147310434|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.113||0.0123|TWO_SIDED|95.0|-0.51|-0.06|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||-0.06|-0.51|0.0123
73888779|NCT03763877|147310435|SUPERIORITY||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.2172||0.251|TWO_SIDED|95.0|-0.682|0.18|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.180|-0.682|0.2510
73888780|NCT03763877|147310435|SUPERIORITY||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.2202||0.8246|TWO_SIDED|95.0|-0.486|0.388|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.388|-0.486|0.8246
73888781|NCT03763877|147310435|SUPERIORITY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.2216||0.9067|TWO_SIDED|95.0|-0.466|0.414|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.414|-0.466|0.9067
73888782|NCT03763877|147310436|SUPERIORITY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.0468||0.6951|TWO_SIDED|95.0|-0.111|0.075|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.075|-0.111|0.6951
73888783|NCT03763877|147310436|SUPERIORITY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.0472||0.103|TWO_SIDED|95.0|-0.171|0.016|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.016|-0.171|0.1030
73888784|NCT03763877|147310436|SUPERIORITY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.0471||0.8583|TWO_SIDED|95.0|-0.085|0.102|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.102|-0.085|0.8583
73888785|NCT03763877|147310437|SUPERIORITY||Mean Difference (Final Values)|-0.105|STANDARD_ERROR_OF_MEAN|0.1777||0.5576|TWO_SIDED|95.0|-0.457|0.248|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.248|-0.457|0.5576
73888786|NCT03763877|147310437|SUPERIORITY||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.1799||0.4261|TWO_SIDED|95.0|-0.213|0.501|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.501|-0.213|0.4261
73888787|NCT03763877|147310437|SUPERIORITY||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.1822||0.6571|TWO_SIDED|95.0|-0.281|0.443|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.443|-0.281|0.6571
73888788|NCT03763877|147310438|SUPERIORITY||Mean Difference (Final Values)|-0.161|STANDARD_ERROR_OF_MEAN|0.2851||0.5732|TWO_SIDED|95.0|-0.727|0.405|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.405|-0.727|0.5732
73888789|NCT03763877|147310438|SUPERIORITY||Mean Difference (Final Values)|-0.139|STANDARD_ERROR_OF_MEAN|0.2884||0.6312|TWO_SIDED|95.0|-0.712|0.434|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.434|-0.712|0.6312
73888790|NCT03763877|147310438|SUPERIORITY||Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.2865||0.4857|TWO_SIDED|95.0|-0.769|0.368|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.368|-0.769|0.4857
73888791|NCT03763877|147310439|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.074||0.5737|TWO_SIDED|95.0|-0.11|0.19|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.19|-0.11|0.5737
73888792|NCT03763877|147310439|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.074||0.7563|TWO_SIDED|95.0|-0.12|0.17|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.17|-0.12|0.7563
73888793|NCT03763877|147310439|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.075||0.5695|TWO_SIDED|95.0|-0.19|0.11|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.11|-0.19|0.5695
73888794|NCT03763877|147310440|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.659||0.9552|TWO_SIDED|95.0|-1.34|1.27|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.27|-1.34|0.9552
73888795|NCT03763877|147310440|SUPERIORITY||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.674||0.2633|TWO_SIDED|95.0|-2.1|0.58|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.58|-2.10|0.2633
73888796|NCT03763877|147310440|SUPERIORITY||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.673||0.1962|TWO_SIDED|95.0|-2.21|0.46|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.46|-2.21|0.1962
73888797|NCT03763877|147310441|SUPERIORITY||Odds Ratio (OR)|1.353||||0.8245|TWO_SIDED|95.0|0.094|19.554|||Regression, Logistic|||||19.554|0.094|0.8245
73888798|NCT03763877|147310441|SUPERIORITY||Odds Ratio (OR)|2.791||||0.414|TWO_SIDED|95.0|0.238|32.752|||Regression, Logistic|||||32.752|0.238|0.4140
73888799|NCT03763877|147310441|SUPERIORITY||Odds Ratio (OR)|14.872||||0.0341|TWO_SIDED|95.0|1.226|180.452|||Regression, Logistic|||||180.452|1.226|0.0341
73888800|NCT03763877|147310442|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|5.84||0.4626|TWO_SIDED|95.0|-16.1|7.5|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.5|-16.1|0.4626
73888801|NCT03763877|147310442|SUPERIORITY||Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|5.88||0.316|TWO_SIDED|95.0|-17.9|5.9|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.9|-17.9|0.3160
73888802|NCT03763877|147310442|SUPERIORITY||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|6.19||0.0204|TWO_SIDED|95.0|-27.4|-2.4|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-2.4|-27.4|0.0204
73888803|NCT03763877|147310443|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|3.91||0.4601|TWO_SIDED|95.0|-10.8|5.0|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.0|-10.8|0.4601
73888804|NCT03763877|147310443|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|3.95||0.9782|TWO_SIDED|95.0|-8.1|7.9|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.9|-8.1|0.9782
73888805|NCT03763877|147310443|SUPERIORITY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|4.13||0.0205|TWO_SIDED|95.0|-18.3|-1.6|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-1.6|-18.3|0.0205
73888806|NCT03763877|147310444|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.538||0.9529|TWO_SIDED|95.0|-1.12|1.05|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.05|-1.12|0.9529
73888807|NCT03763877|147310444|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.532||0.1285|TWO_SIDED|95.0|-1.9|0.25|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.25|-1.90|0.1285
73888808|NCT03763877|147310444|SUPERIORITY||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|0.565||0.0417|TWO_SIDED|95.0|-2.32|-0.05|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.05|-2.32|0.0417
73888809|NCT03763877|147310445|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3141|TWO_SIDED|95.0|-0.69|0.23|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.23|-0.69|0.3141
73888810|NCT03763877|147310445|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.226||0.0656|TWO_SIDED|95.0|-0.88|0.03|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.03|-0.88|0.0656
73888811|NCT03763877|147310445|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.237||0.0101|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||-0.16|-1.12|0.0101
73888812|NCT03537404|147310460|OTHER||Geometric Mean Ratio|0.02|||||TWO_SIDED|90.0|-0.103|0.142|||||Cmax parameters were logarithmically transformed|||0.142|-0.103|
73888813|NCT03537404|147310460|OTHER||Geometric Mean Ratio|-0.022|||||TWO_SIDED|90.0|-0.22|0.175|||||Cmax parameters were logarithmically transformed|||0.175|-0.220|
73888814|NCT03537404|147310461|OTHER||Geometric Mean Ratio|0.041|||||TWO_SIDED|90.0|-0.075|0.157|||||AUCtau parameters were logarithmically transformed.|||0.157|-0.075|
73888815|NCT03537404|147310461|OTHER||Geometric Mean Ratio|-0.069|||||TWO_SIDED|90.0|-0.201|0.064|||||AUCtau parameters were logarithmically transformed|||0.064|-0.201|
73888816|NCT03537404|147310462|OTHER||Geometric Mean Ratio|0.271|||||TWO_SIDED|90.0|0.159|0.383|||||Cmax parameters were logarithmically transformed|||0.383|0.159|
73888817|NCT03537404|147310463|OTHER||Geometric Mean Ratio|0.074|||||TWO_SIDED|90.0|0.016|0.132|||||AUCtau parameters were logarithmically transformed|||0.132|0.016|
73888818|NCT03537404|147310464|OTHER||Geometric Mean Ratio|-0.148|||||TWO_SIDED|90.0|-0.45|0.153|||||Cmax parameters were logarithmically transformed|||0.153|-0.450|
73888819|NCT03537404|147310465|OTHER||Geometric Mean Ratio|-0.093|||||TWO_SIDED|90.0|-0.354|0.168|||||AUCtau parameters were logarithmically transformed|||0.168|-0.354|
73888820|NCT00068692|147310471|SUPERIORITY|||||||0.35||||||One-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiotherapy, and regimen administration||||||0.35
73888821|NCT00068692|147310471|SUPERIORITY|||||||0.69||||||one-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiaotherapy, regimen administration||||||0.69
73888822|NCT00248040|147310492|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.275||||0.9076|TWO_SIDED|95.0|-5.0|4.45|||Other|||This analysis refers to the 1-3 hours time point||4.45|-5.00|0.9076
73888823|NCT00248040|147310492|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|2.444||||0.3084|TWO_SIDED|95.0|-2.32|7.21|||Other|||This analysis refers to the 1-3 hours timepoint.||7.21|-2.32|0.3084
73888824|NCT00248040|147310492|OTHER||Difference between means|-2.719||||0.2565|TWO_SIDED|95.0|-7.47|2.03|||Other|||||2.03|-7.47|0.2565
73888825|NCT00248040|147310492|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.063||||0.9855|TWO_SIDED|95.0|-6.91|6.79|||Other|||This analysis refers to the 10-12 hours time point.||6.79|-6.91|0.9855
73888826|NCT00248040|147310492|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|4.519||||0.1934|TWO_SIDED|95.0|-2.36|11.39|||Other|||This analysis refers to the 10-12 hours timepoint.||11.39|-2.36|0.1934
73888827|NCT00248040|147310492|OTHER|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-4.582||||0.1797|TWO_SIDED|95.0|-11.3|2.17|||Other|||This analysis refers to the 10-12 hours time point.||2.17|-11.3|0.1797
73888828|NCT00602472|147310553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|-0.73|-0.5|||ANCOVA|||Linagliptin vs. Placebo||-0.50|-0.73|<0.0001
73888829|NCT00602472|147310554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.56|-0.41|||ANCOVA|||Linagliptin vs. Placebo||-0.41|-0.56|<0.0001
73888830|NCT00602472|147310555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.78|-0.58|||ANCOVA|||Linagliptin vs. Placebo||-0.58|-0.78|<0.0001
73888831|NCT00602472|147310556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.8|-0.59|||ANCOVA|||Linagliptin vs. Placebo||-0.59|-0.80|<0.0001
73888832|NCT00602472|147310557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001||95.0|-18.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-18.1|<0.0001
73888833|NCT00602472|147310558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001||95.0|-22.4|-13.2|||ANCOVA|||Linagliptin vs. Placebo||-13.2|-22.4|<0.0001
73888834|NCT00602472|147310559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-20.3|-11.1|||ANCOVA|||Linagliptin vs. Placebo||-11.1|-20.3|<0.0001
73888835|NCT00602472|147310560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001||95.0|-17.2|-7.1|||ANCOVA|||Linagliptin vs. Placebo||-7.1|-17.2|<0.0001
73888836|NCT00602472|147310561|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.51|||<|0.0001||95.0|3.332|9.111|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||9.111|3.332|<0.0001
73888837|NCT00602472|147310563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.818|||<|0.0001||95.0|1.989|7.327|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||7.327|1.989|<0.0001
73888838|NCT00602472|147310565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36|||<|0.0001||95.0|2.474|4.562|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||4.562|2.474|<0.0001
73888839|NCT03038880|147310566|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-2.1|||||TWO_SIDED|80.0|-6.8|2.6|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|||2.6|-6.8|
73888840|NCT03038880|147310566|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.1|||||TWO_SIDED|80.0|-3.4|5.5|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|||5.5|-3.4|
73888841|NCT03038880|147310567|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-2.09|||||TWO_SIDED|80.0|-6.75|2.56|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||2.56|-6.75|
73888842|NCT03038880|147310567|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.05|||||TWO_SIDED|80.0|-3.4|5.49|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||5.49|-3.40|
73888843|NCT03038880|147310567|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|0.49|||||TWO_SIDED|80.0|-4.26|5.25|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||5.25|-4.26|
73888844|NCT03038880|147310567|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.83|||||TWO_SIDED|80.0|-2.71|6.37|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||6.37|-2.71|
73888845|NCT03038880|147310569|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|4.76|||||TWO_SIDED|80.0|-15.92|25.44|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||25.44|-15.92|
73888846|NCT03038880|147310569|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|5.95|||||TWO_SIDED|80.0|-13.62|25.53|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||25.53|-13.62|
73888847|NCT03038880|147310569|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-4.17|||||TWO_SIDED|80.0|-24.52|16.19|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||16.19|-24.52|
73888848|NCT03038880|147310569|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|8.93|||||TWO_SIDED|80.0|-10.73|28.59|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||28.59|-10.73|
73888849|NCT03038880|147310571|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-4.76|||||TWO_SIDED|80.0|-10.72|1.19|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||1.19|-10.72|
73888850|NCT03038880|147310571|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-3.57|||||TWO_SIDED|80.0|-8.07|0.92|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||0.92|-8.07|
73888851|NCT03038880|147310571|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|0.0|||||||||||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||||
73888852|NCT03038880|147310571|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-3.57|||||TWO_SIDED|80.0|-8.07|0.92|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||0.92|-8.07|
73888853|NCT03038880|147310572|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|21.9|||||TWO_SIDED|80.0|0.76|43.05|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||43.05|0.76|
73888854|NCT03038880|147310572|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|38.57|||||TWO_SIDED|80.0|19.56|57.59|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||57.59|19.56|
73888855|NCT03038880|147310572|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|19.64|||||TWO_SIDED|80.0|-1.14|40.43|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||40.43|-1.14|
73888856|NCT03038880|147310572|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|33.93|||||TWO_SIDED|80.0|14.95|52.91|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||52.91|14.95|
73888857|NCT03038880|147310573|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|0.0|||||||||||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||||
73888858|NCT03038880|147310573|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|3.57|||||TWO_SIDED|80.0|-0.92|8.07|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||8.07|-0.92|
73888859|NCT03038880|147310573|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|4.76|||||TWO_SIDED|80.0|-1.19|10.72|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||10.72|-1.19|
73888860|NCT03038880|147310573|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|3.57|||||TWO_SIDED|80.0|-0.92|8.07|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||8.07|-0.92|
73888861|NCT03038880|147310574|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|0.45|||||TWO_SIDED|80.0|-29.81|30.71|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||30.71|-29.81|
73888862|NCT03038880|147310574|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|14.68|||||TWO_SIDED|80.0|-14.29|43.65|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||43.65|-14.29|
73888863|NCT03038880|147310574|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-4.85|||||TWO_SIDED|80.0|-30.57|20.87|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||20.87|-30.57|
73888864|NCT03038880|147310574|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.12|||||TWO_SIDED|80.0|-23.57|25.8|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||25.80|-23.57|
73888865|NCT03038880|147310575|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-12.23|||||TWO_SIDED|80.0|-36.6|12.15|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||12.15|-36.60|
73888866|NCT03038880|147310575|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|4.98|||||TWO_SIDED|80.0|-18.5|28.45|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||28.45|-18.50|
73888867|NCT03038880|147310575|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-8.64|||||TWO_SIDED|80.0|-30.42|13.14|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||13.14|-30.42|
73888868|NCT03038880|147310575|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|7.36|||||TWO_SIDED|80.0|-13.65|28.37|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||28.37|-13.65|
73888869|NCT01002339|147310585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||||||0.02
73888870|NCT01002339|147310586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Chi-squared|||||||0.06
73888871|NCT01002339|147310587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Chi-squared|||||||0.9
73888872|NCT01002339|147310588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Chi-squared|||||||0.07
73888873|NCT01002339|147310589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|||||||ANOVA|||||||0.2
73888874|NCT01002339|147310590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||ANOVA|||||||0.4
73888875|NCT01002339|147310591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||ANOVA|||||||0.8
73888876|NCT01002339|147310592|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||ANOVA|||||||0.56
73888877|NCT01002339|147310593|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Kruskal-Wallis|||||||0.8
73888878|NCT01002339|147310594|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||ANOVA|||||||0.66
73888879|NCT01002339|147310595|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|||||||ANOVA|||||||0.37
73888880|NCT01002339|147310596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||ANOVA|||||||0.45
73888881|NCT01002339|147310597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||ANOVA|||||||0.50
73888882|NCT01002339|147310598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|||||||Chi-squared|||||||0.17
73888883|NCT01002339|147310599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||ANOVA|||||||0.5
73888884|NCT01002339|147310600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Chi-squared|||||||0.9
73888885|NCT00790842|147310610|OTHER|Recommended Phase 2 dose for Group A|Dose in milligrams per day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose for patients with creatinine clearance of 30 to 60 mL/min is 25 mg/day|Recommended Phase 2 dose for Group A||||
73888886|NCT00790842|147310610|OTHER|Recommended phase 2 dose for patients in Group B|Dose in milligrams/day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/minute who are not on dialysis|Recommended phase 2 dose for patients in Group B||||
73888887|NCT00790842|147310610|OTHER|Recommended phase 2 dose for Group C|Lenalidomide dose in mg/day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/min who are receiving dialysis|Recommended phase 2 dose for Group C||||
73888888|NCT02158546|147310642|SUPERIORITY||Least square means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.782|TWO_SIDED|95.0|-2.1|1.6|||Mixed Models Analysis|||||1.6|-2.1|0.782
73888889|NCT01208207|147310682|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The etoricoxib dose (90 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the least squares (LS) mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|-0.64|||||TWO_SIDED|95.0|-5.47|4.19|||ANCOVA|||||4.19|-5.47|
73888890|NCT01208207|147310683|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The etoricoxib dose (60 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the LS mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|1.59|||||TWO_SIDED|95.0|-2.19|5.37|||ANCOVA|||||5.37|-2.19|
73888891|NCT01208207|147310684|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-1.58||||0.396|TWO_SIDED|80.0|-3.96|0.81|||ANCOVA|||||0.81|-3.96|0.396
73888892|NCT01208207|147310685|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-2.7||||0.112||80.0|-4.88|-0.52|||ANCOVA|||||-0.52|-4.88|0.112
73888893|NCT02177032|147310689|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at day 50 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-1.0|||||TWO_SIDED|95.0|-2.4|0.0|||Fisher Exact|||||0|-2.4|
73888894|NCT02177032|147310690|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667."|Vaccine Group Ratios|0.46|||||TWO_SIDED|95.0|0.37|0.58|||ANOVA|||||0.58|0.37|
73888895|NCT02177032|147310691|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 8)"|Vaccine Group Ratios|1.04|||||TWO_SIDED|95.0|0.84|1.29|||ANOVA|||||1.29|0.84|
73888896|NCT02177032|147310691|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 15)"|Vaccine Group Ratios|1.68|||||TWO_SIDED|95.0|1.35|2.1|||ANOVA|||||2.1|1.35|
73888897|NCT02177032|147310691|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 91)."|Vaccine Group Ratios|0.68|||||TWO_SIDED|95.0|0.54|0.85|||ANOVA|||||0.85|0.54|
73888898|NCT02177032|147310691|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 181)"|Vaccine Group Ratios|1.22|||||TWO_SIDED|95.0|0.94|1.59|||ANOVA|||||1.59|0.94|
73888899|NCT02177032|147310691|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 366)"|Vaccine Group Ratios|1.67|||||TWO_SIDED|95.0|1.27|2.19|||ANOVA|||||2.19|1.27|
73888900|NCT02177032|147310692|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|9.0|||||TWO_SIDED|95.0|3.8|13.9|||Fisher Exact|||||13.9|3.8|
73888901|NCT02177032|147310692|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.6|||Fisher Exact|||||1.6|-1|
73888902|NCT02177032|147310692|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-3.0|||||TWO_SIDED|95.0|-6.0|-1.4|||Fisher Exact|||||-1.4|-6|
73888903|NCT02177032|147310692|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-1.0|||||TWO_SIDED|95.0|-4.5|3.2|||Fisher Exact|||||3.2|-4.5|
73888904|NCT02177032|147310692|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|6.0|||||TWO_SIDED|95.0|1.3|11.5|||Fisher Exact|||||11.5|1.3|
73888905|NCT02177032|147310693|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-11.0|||||TWO_SIDED|95.0|-19.6|-1.0|||Fisher Exact|||||-1|-19.6|
73888906|NCT02177032|147310693|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|0.0|||||TWO_SIDED|95.0|-5.6|2.6|||Fisher Exact|||||2.6|-5.6|
73888907|NCT02177032|147310693|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-15.0|||||TWO_SIDED|95.0|-26.0|-7.1|||Fisher Exact|||||-7.1|-26|
73888908|NCT02177032|147310693|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-17.0|||||TWO_SIDED|95.0|-29.0|-7.1|||Fisher Exact|||||-7.1|-29|
73888909|NCT02177032|147310693|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-25.0|||||TWO_SIDED|95.0|-37.8|-13.2|||Fisher Exact|||||-13.2|-37.8|
73888910|NCT00942604|147310774|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
73888911|NCT00942604|147310775|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
73888912|NCT05567783|147310788|SUPERIORITY||Relative risk reduction (RRR, %)|15.85||||0.5552|TWO_SIDED|95.0|-49.27|52.56||two-sided, alpha=0.05|Poisson regression|Estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model|RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group was the only factor in the model|||52.56|-49.27|0.5552
73888913|NCT05567783|147310788|SUPERIORITY||Relative risk reduction (RRR, %)|3.78|||||TWO_SIDED|95.0|-67.23|44.63|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||44.63|-67.23|
73888914|NCT05567783|147310796|SUPERIORITY||Relative risk reduction (RRR, %)|57.23|||||TWO_SIDED|95.0|-2.51|82.15|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.|||82.15|-2.51|
73888915|NCT05567783|147310796|SUPERIORITY||Relative risk reduction (RRR, %)|11.45|||||TWO_SIDED|95.0|-76.25|55.51|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||55.51|-76.25|
73888916|NCT05567783|147310797|SUPERIORITY||Relative risk reduction (RRR, %)|44.13|||||TWO_SIDED|95.0|-50.49|79.26|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.|||79.26|-50.49|
73888917|NCT05567783|147310797|SUPERIORITY||Relative risk reduction (RRR, %)|-9.8|||||TWO_SIDED|95.0|-147.41|51.27|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||51.27|-147.41|
73888918|NCT04916587|147310798|SUPERIORITY||Risk Difference (RD)|11.6|||||TWO_SIDED|95.0|10.6|12.6||||||||12.6|10.6|
73888919|NCT04916587|147310799|SUPERIORITY||Risk Difference (RD)|7.5|||||TWO_SIDED|95.0|6.6|8.3||||||||8.3|6.6|
73888920|NCT04916587|147310800|SUPERIORITY||Odds Ratio (OR)|0.36||||0.03|TWO_SIDED|90.0|0.14|0.89|||Mixed Models Analysis|||||0.89|0.14|0.03
73888921|NCT00999102|147310808|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.67|TWO_SIDED|95.0|-1.86|2.86|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 5 mg minus Mean Global Fatigue Score for Metoprolol 50 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).||2.86|-1.86|0.67
73897306|NCT00492063|147327653|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.27|||||TWO_SIDED|95.0|1.11|1.4||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.||1.4|1.11|
73888922|NCT00999102|147310808|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.72|TWO_SIDED|95.0|-3.17|4.55|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 10 mg minus Mean Global Fatigue Score for Metoprolol 100 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).||4.55|-3.17|0.72
73888923|NCT00999102|147310809|SUPERIORITY||Mean Difference (Final Values)|-7.03||||0.89|TWO_SIDED|95.0|-108.99|94.92|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 5 mg minus Mean Treadmill Exercise Time for Metoprolol 50 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).||94.92|-108.99|0.89
73888924|NCT00999102|147310809|SUPERIORITY||Mean Difference (Final Values)|-25.9||||0.43|TWO_SIDED|95.0|-91.55|39.75|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 10 mg minus Mean Treadmill Exercise Time for Metoprolol 100 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).||39.75|-91.55|0.43
73888925|NCT03326713|147310838|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.0001|TWO_SIDED|95.0|2.5|15.2|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (TP vs TCN)||15.2|2.5|<.0001
73888926|NCT03326713|147310838|SUPERIORITY||Odds Ratio (OR)|7.4|||<|0.0001|TWO_SIDED|95.0|2.8|19.4|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TCN)||19.4|2.8|<.0001
73888927|NCT03326713|147310838|SUPERIORITY||Odds Ratio (OR)|1.2||||1.2|TWO_SIDED|95.0|0.4|4.0|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TP)||4.0|0.4|1.2
73888928|NCT01198977|147310897|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.013||||||Baseline and 3-month follow-up for arm 1 and arm 2.|ANOVA|||||||.013
73897307|NCT01947855|147327664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-104.87|STANDARD_ERROR_OF_MEAN|19.88|<|0.0001|TWO_SIDED|95.0|-144.77|-64.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 25 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.||-64.97|-144.77|<0.0001
73888929|NCT01198977|147310897|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.005||||||Comparing baseline to 6-month follow-up.|ANOVA|||||||0.005
73897308|NCT01947855|147327664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-85.49|STANDARD_ERROR_OF_MEAN|20.18|<|0.0001|TWO_SIDED|95.0|-126.01|-44.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 10 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.||-44.97|-126.01|<0.0001
73888930|NCT01198977|147310897|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.01||||||The interaction effect between the two conditions across time. Baseline, 3-month, 6-month.|ANOVA|||||||0.010
73897309|NCT00821509|147327665|SUPERIORITY_OR_OTHER||ratio of proportions|1.03||||0.004|||||||proportion test|The test was carried out using the proportions calculated from the number of sick-leave episodes over the number o total follow-up weeks in each arm||According to the null hypothesis the proportion of weeks with an onset of days-off period in neither of the intervention arms was different from that of control. No in advance power calculations were done.||||0.004
73897310|NCT00821509|147327666|SUPERIORITY_OR_OTHER||ratio of proportions|0.933||||0.04|||||||proportion test|||According to the null hypothesis the proportion of weeks with an onset of an infectious disease period in neither of the intervention arms was different from that of control. No in advance power calculations were done.||||0.04
73888931|NCT01198977|147310898|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.009||||||Comparing depression scores for the telephone counseling and education counseling groups at 6 months.|ANOVA|||||||0.009
73888932|NCT01198977|147310898|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group X Time interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.032||||||Interaction effects between the telephone counseling and education counseling groups over time (baseline, 3 months, 6 months).|ANOVA|||||||.032
73888933|NCT01198977|147310899|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.049||||||Physical Activity Interaction effect between the Telephone Counseling and Education Counseling Group over time (baseline, 3 months, 6 months).|ANOVA|||||||0.049
73888934|NCT01198977|147310899|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.014||||||Comparing physical activity scores for the telephone counseling and education counseling groups at 6 months.|ANOVA|||||||.014
73888935|NCT01285557|147310900|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9312|TWO_SIDED|95.0|0.76|1.28|||Unstratified Log-rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the unstratified log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.28|0.76|0.9312
73888936|NCT01285557|147310901|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3039|TWO_SIDED|95.0|0.65|1.14|||Log Rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.14|0.65|0.3039
73888937|NCT01285557|147310902|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1683|TWO_SIDED|95.0|0.66|1.08|||Log Rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.08|0.66|0.1683
73888938|NCT04922216|147310919|SUPERIORITY||Mean Difference (Net)|0.3||||0.52|TWO_SIDED|95.0|-0.61|1.2|||Mixed Models Analysis|Degrees of freedom (2,622)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 6 months).||1.20|-0.61|0.52
73888939|NCT04922216|147310919|SUPERIORITY||Mean Difference (Net)|-0.28||||0.54|TWO_SIDED|95.0|-1.19|0.63|||Mixed Models Analysis|Degrees of freedom (2,622)|Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).||0.63|-1.19|0.54
73888940|NCT04922216|147310919|SUPERIORITY||Mean Difference (Net)|0.4||||0.39|TWO_SIDED|95.0|-0.5|1.31|||Mixed Models Analysis|Degrees of freedom (2,622)|Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).||1.31|-0.50|0.39
73888941|NCT04922216|147310919|SUPERIORITY||Mean Difference (Net)|0.39||||0.7|TWO_SIDED|95.0|-0.52|1.3|||Mixed Models Analysis|Degrees of freedom (2,622)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 6 months).||1.30|-0.52|0.70
73888942|NCT04922216|147310919|SUPERIORITY||Mean Difference (Net)|-0.55||||0.47|TWO_SIDED|95.0|-1.45|0.36|||Mixed Models Analysis|Degrees of freedom (2,622)|No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 6 months).||0.36|-1.45|0.47
73888943|NCT04922216|147310920|SUPERIORITY||Mean Difference (Net)|0.24||||0.43|TWO_SIDED|95.0|-0.36|0.84|||Mixed Models Analysis|DF (2,622)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 3 months).||0.84|-0.36|0.43
73888944|NCT04922216|147310920|SUPERIORITY||Mean Difference (Net)|-0.42||||0.17|TWO_SIDED|95.0|-1.01|0.18|||Mixed Models Analysis|DF (2,622)|Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).||0.18|-1.01|0.17
73888945|NCT04922216|147310920|SUPERIORITY||Mean Difference (Net)|0.53||||0.08|TWO_SIDED|95.0|-0.06|1.13|||Mixed Models Analysis|DF (2,622)|Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).||1.13|-0.06|0.08
73888946|NCT04922216|147310920|SUPERIORITY||Mean Difference (Net)|0.32||||0.58|TWO_SIDED|95.0|-0.28|0.91|||Mixed Models Analysis|DF (2,622)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 3 months).||0.91|-0.28|0.58
73888947|NCT04922216|147310920|SUPERIORITY||Mean Difference (Net)|-0.32||||0.55|TWO_SIDED|95.0|-0.91|0.28|||Mixed Models Analysis|DF (2,622)|No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 3 months).||0.28|-0.91|0.55
73888948|NCT04922216|147310921|SUPERIORITY||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.7|1.39|||Chi-squared|DF (1)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard dietary monitoring and simplified dietary monitoring (factor 1).||1.39|0.70|0.95
73888949|NCT04922216|147310921|SUPERIORITY||Odds Ratio (OR)|1.46||||0.03|TWO_SIDED|95.0|1.03|2.05|||Chi-squared|DF (1)|Weekly adaptive activity goals coded as 0 (reference) and daily adaptive activity goals coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between weekly adaptive activity goals and daily adaptive activity goals (factor 2).||2.05|1.03|0.03
73888950|NCT04922216|147310921|SUPERIORITY||Odds Ratio (OR)|0.85||||0.36|TWO_SIDED|95.0|0.6|1.2|||Chi-squared|DF (1)|Fixed decision points coded as 0 (reference) and adaptive decision points coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between fixed message decision points and adaptive message decision points (factor 3).||1.20|0.60|0.36
73888951|NCT04922216|147310921|SUPERIORITY||Odds Ratio (OR)|1.01||||0.95|TWO_SIDED|95.0|0.72|1.42|||Chi-squared|DF (1)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard message decision rules and adaptive message decision rules (factor 4).||1.42|0.72|0.95
73888952|NCT04922216|147310921|SUPERIORITY||Odds Ratio (OR)|1.2||||0.29|TWO_SIDED|95.0|0.85|1.69|||Chi-squared|DF (1)|No message choice coded as 0 (reference) and message choice coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between no message choice and message choice (factor 5).||1.69|0.85|0.29
73888953|NCT04145349|147310933|SUPERIORITY||Posterior Mean Hazard Ratio|0.69|||||TWO_SIDED|98.0|0.25|1.69|||Bayesian hierarchical model|||The Bayesian analyses below include posterior mean of Hazard ratio, and credible intervals instead of confidence intervals.|The posterior probability treatment difference is 0.864|1.69|0.25|
73888954|NCT01148979|147310955|OTHER|A Paired sample t-test was used to test the null hypothesis of no difference in MDAR score change after 4 weeks of treatment with Vyvanse versus placebo.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analysis represents a within-subject comparison of change under treatment with Vyvanse versus change under treatment with placebo, using paired t-tests with each subject as their own control. All tests reported are two-tailed.||||<0.05
73888955|NCT01646125|147310956|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76|||||TWO_SIDED|90.0|0.35|1.63||||||||1.63|0.35|
73888956|NCT00918255|147310993|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.022
73888957|NCT00918255|147310993|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.025
73888958|NCT00918255|147310993|SUPERIORITY_OR_OTHER|||||||0.252||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.252
73888959|NCT00918255|147310994|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|ANCOVA|||||||0.062
73888960|NCT00918255|147310994|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).||||||0.019
73888961|NCT00918255|147310994|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).||||||0.286
73888962|NCT00918255|147310995|SUPERIORITY_OR_OTHER|||||||1||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||1.000
73888963|NCT00918255|147310995|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||1.000
73888964|NCT00918255|147310995|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.097
73888965|NCT00918255|147310996|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.044
73888966|NCT00918255|147310996|SUPERIORITY_OR_OTHER|||||||0.051||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.051
73888967|NCT00918255|147310996|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.320
73888968|NCT00918255|147310997|SUPERIORITY_OR_OTHER|||||||1||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||1.000
73888969|NCT00918255|147310997|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||1.000
73888970|NCT00918255|147310997|SUPERIORITY_OR_OTHER|||||||0.673||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.673
73888971|NCT00918255|147310998|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.012
73888972|NCT00918255|147310998|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.020
73888973|NCT00918255|147310998|SUPERIORITY_OR_OTHER|||||||0.721||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.721
73888974|NCT00918255|147310999|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Van Elteren test|||||||0.045
73888975|NCT00918255|147310999|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.||||||0.014
73888976|NCT00918255|147310999|SUPERIORITY_OR_OTHER|||||||0.169||95.0|||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.||||||0.169
73888977|NCT01244893|147311014|NON_INFERIORITY_OR_EQUIVALENCE|This study uses -0.05 LogMAR as the non-inferiority margin.|Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.003|||TWO_SIDED|95.0|-0.00092|0.01045|||Mixed Models Analysis||The mean difference is calculated as the test lens - control lens.|"Ho: after time period (6-8 days of lens wear), the test lens - control lens will be greater than or equal to the non-inferiority margin specified .~Ha: after time period, test-control will be less than the margin specified concluding that the test lens will be inferior to control lens in terms of LogMAR scale"||0.01045|-0.00092|
73888978|NCT00357552|147311018|NON_INFERIORITY_OR_EQUIVALENCE|Success of the strategy is assessed according to whether the lower bound of the exact 90% confidence interval of this proportion is greater than 65%.|proportion|87.0|||||TWO_SIDED|90.0|81.0|92.0|||confidence interval|Success was determined by whether the lower bound of the 90% exact confidence interval was greater than 65%.|exact confidence interval|The null hypothesis was that LPV/r monotherapy provides at least a 65% short-term virologic response. The target sample size was 120 subjects. Assuming an underlying true 24 week success rate of 76%, this sample size was chosen in order to provide at least 90% power to show that the true 24 week virologic success rate of LPV/r monotherapy in this population is greater than 65%.||92|81|
73888979|NCT02054104|147311106|OTHER|||||||0.36|||||||Mann-Whitney U test|||||||0.36
73888980|NCT00084136|147311109|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||<|0.01|TWO_SIDED|95.0|1.12|2.04||Not adjusted for multiple interim analyses. Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Log Rank|Log-rank test was stratified by country and screening RNA (\< 100,000 c/mL vs \>= 100,000 copies/mL).|The HR is for ddI+FTC+ATV vs. ZDV/3TC+EFV.|||2.04|1.12|<0.01
73888981|NCT00084136|147311110|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.72|1.27|||Other||The HR is for TDF/FTC+EFV vs. ZDV/3TC+EFV.|While original study design specified a non-inferiority test, study follow-up stopped early, not due to treatment effect size or futility, but due to slowing accumulation of primary outcome events. Therefore, 2-sided, 95% confidence intervals about the estimated treatment effect (relative effect estimated by a hazard ratio) are provided.||1.27|0.72|
73888982|NCT00836693|147311129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|2.2|5.5||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||5.5|2.2|<0.001
73888983|NCT00836693|147311130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|5.1|18.3||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||18.3|5.1|<0.001
73888984|NCT00836693|147311131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.0|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|8.9|27.0||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||27.0|8.9|<0.001
73888985|NCT00836693|147311135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|9.5|22.8||P-value is for Week 12 change. For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The change from baseline to endpoint in morning erection percentages was analyzed with an ANCOVA model including terms for baseline value, treatment group, country, age and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||22.8|9.5|<0.001
73888986|NCT00836693|147311136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|STANDARD_ERROR_OF_MEAN|3.11|>|0.001|TWO_SIDED|95.0|13.9|26.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANOVA|||The models included terms for baseline value of the efficacy variable,treatment group,country, and the baseline-by-treatment-group interaction.In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||26.1|13.9|>0.001
73888987|NCT00836693|147311137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|5.5|18.0||p-value is for Total (Change). For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||18.0|5.5|<0.001
73888988|NCT00836693|147311137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|6.6|19.8||p-value is for Sexual Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||19.8|6.6|<0.001
73888989|NCT00836693|147311137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|STANDARD_ERROR_OF_MEAN|3.34||0.0034|TWO_SIDED|95.0|3.3|16.5||p-value is for Confidence Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||16.5|3.3|0.0034
73888990|NCT00836693|147311137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|3.52||0.002|TWO_SIDED|95.0|4.1|17.9||p-value is for Self-Esteem Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||17.9|4.1|0.0020
73888991|NCT00836693|147311137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|STANDARD_ERROR_OF_MEAN|4.07||0.0653|TWO_SIDED|95.0|-0.5|15.6||p-value is for Overall Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||15.6|-0.5|0.0653
73888992|NCT00836693|147311138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|0.7|1.9||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.9|0.7|<0.001
73888993|NCT00836693|147311139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.25||0.0089|TWO_SIDED|95.0|0.2|1.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.1|0.2|0.0089
73888994|NCT00836693|147311140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.37||0.0461|TWO_SIDED|95.0|0.0|1.5||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.5|0.0|0.0461
73888995|NCT00836693|147311141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|0.7|1.9||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.9|0.7|<0.001
73888996|NCT00836693|147311142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|2.22||0.0047|TWO_SIDED|95.0|2.0|10.7||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||10.7|2.0|0.0047
73888997|NCT00836693|147311143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.5|STANDARD_ERROR_OF_MEAN|4.99|<|0.001|TWO_SIDED|95.0|14.6|34.3||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||34.3|14.6|<0.001
73888998|NCT00836693|147311144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.5|STANDARD_ERROR_OF_MEAN|4.96|<|0.001|TWO_SIDED|95.0|13.7|33.2||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||33.2|13.7|<0.001
73888999|NCT00836693|147311145|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Global Assessment Questions GAQ1. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.||||<0.0001
73889000|NCT00836693|147311146|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Global Assessment Question GAQ2.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.||||<0.0001
73889001|NCT01750229|147311165|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|Variables included in the Mixed Model were: baseline VAS back pain score, treatment group, and period.||||||0.002
73889002|NCT03408392|147311195|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.38|||||TWO_SIDED|90.0|96.11|115.54||||||||115.54|96.11|
73889003|NCT03408392|147311196|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|101.14|||||TWO_SIDED|90.0|93.37|109.55||||||||109.55|93.37|
73889004|NCT03408392|147311197|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.14|||||TWO_SIDED|90.0|96.31|114.78||||||||114.78|96.31|
73889005|NCT00885170|147311219|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.67|||<|0.001|TWO_SIDED|95.0|1.17|4.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|The primary hypothesis of the study was met if; in postmenopausal women previously treated with alendronate with low BMD, two years of treatment with odanacatib 50 mg significantly increased BMD at the femoral neck site compared to placebo (p-value \< 0.001).||4.17|1.17|<0.001
73889006|NCT00885170|147311220|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-5.5|||||TWO_SIDED|95.0|-16.9|6.0|||||Based on Miettinen \& Nurminen method.|||6.0|-16.9|
73889007|NCT00885170|147311221|SUPERIORITY_OR_OTHER||Difference in the Percentage vs. Placebo|5.7|||||TWO_SIDED|95.0|-0.4|12.6|||||Based on Miettinen \& Nurminen method.|||12.6|-0.4|
73889008|NCT00885170|147311222|SUPERIORITY_OR_OTHER||Difference in the least Squares Means|0.88||||0.166|TWO_SIDED|95.0|-0.37|2.14|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||2.14|-0.37|0.166
73889009|NCT00885170|147311223|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|3.18||||0.002|TWO_SIDED|95.0|1.19|5.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||5.17|1.19|0.002
73889010|NCT00885170|147311224|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.0||||0.142|TWO_SIDED|95.0|-0.34|2.35|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||2.35|-0.34|0.142
73889011|NCT00885170|147311225|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.7|||<|0.001|TWO_SIDED|95.0|1.41|4.0|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||4.00|1.41|<0.001
73889012|NCT00885170|147311226|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.06||||0.023|TWO_SIDED|95.0|0.15|1.98|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.98|0.15|0.023
73889013|NCT00885170|147311227|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.57|||<|0.001|TWO_SIDED|95.0|1.26|3.89|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||3.89|1.26|<0.001
73889014|NCT00885170|147311228|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.8||||0.103|TWO_SIDED|95.0|-0.16|1.77|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.77|-0.16|0.103
73889015|NCT00885170|147311229|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.22||||0.763|TWO_SIDED|95.0|-1.23|1.67|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.67|-1.23|0.763
73889016|NCT00885170|147311230|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.38||||0.578|TWO_SIDED|95.0|-0.96|1.72|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.72|-0.96|0.578
73889017|NCT00885170|147311231|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|10.16||||0.5|TWO_SIDED|95.0|-19.39|39.72|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||39.72|-19.39|0.500
73889018|NCT00885170|147311232|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.82||||0.709|TWO_SIDED|95.0|-36.29|24.65|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||24.65|-36.29|0.709
73889019|NCT00885170|147311233|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-47.04|||<|0.001|TWO_SIDED|95.0|-62.4|-31.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||-31.67|-62.40|<0.001
73889020|NCT00885170|147311234|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-46.29|||<|0.001|TWO_SIDED|95.0|-61.43|-31.15|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||-31.15|-61.43|<0.001
73889021|NCT00885170|147311235|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|10.96||||0.186|TWO_SIDED|95.0|-5.29|27.22|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||27.22|-5.29|0.186
73889022|NCT00885170|147311236|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|12.82||||0.015|TWO_SIDED|95.0|2.54|23.1|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||23.10|2.54|0.015
73889023|NCT00885170|147311237|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|31.17||||0.011|TWO_SIDED|95.0|7.13|55.21|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||55.21|7.13|0.011
73889024|NCT00885170|147311238|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|24.01||||0.059|TWO_SIDED|95.0|-0.93|48.94|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||48.94|-0.93|0.059
73889025|NCT00885170|147311239|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.11||||0.846|TWO_SIDED|95.0|-0.95|1.16|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||1.16|-0.95|0.846
73889026|NCT00885170|147311240|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.38||||0.413|TWO_SIDED|95.0|-1.91|4.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||4.67|-1.91|0.413
73889027|NCT00885170|147311241|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.91||||0.326|TWO_SIDED|95.0|-17.66|5.85|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||5.85|-17.66|0.326
73889028|NCT00885170|147311242|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.47||||0.835|TWO_SIDED|95.0|-12.37|15.32|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||15.32|-12.37|0.835
73889029|NCT00885170|147311243|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-3.13||||0.376|TWO_SIDED|95.0|-10.04|3.78|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||3.78|-10.04|0.376
73889030|NCT03771664|147311244|SUPERIORITY||Least Square (LS) Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|2.23||0.1537|TWO_SIDED|95.0|-1.2|7.7||Average change from baseline in SE was analyzed by analysis of covariance (ANCOVA) with explanatory (treatment, baseline antidepressant use, baseline SE) and response variables \[change from baseline in sleep efficiency at Day 14 (EODBT)\].|ANCOVA|||||7.7|-1.2|0.1537
73889031|NCT03771664|147311245|SUPERIORITY||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|8.07||0.1126|TWO_SIDED|95.0|-29.0|3.1||Change from BL in overall WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from baseline (BL) in overall WASO||3.1|-29.0|0.1126
73889032|NCT03771664|147311245|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.63||0.9819|TWO_SIDED|95.0|-3.3|3.2||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 1||3.2|-3.3|0.9819
73889033|NCT03771664|147311245|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|3.19||0.1838|TWO_SIDED|95.0|-10.6|2.1||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 2||2.1|-10.6|0.1838
73889034|NCT03771664|147311245|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|3.97||0.0797|TWO_SIDED|95.0|-15.0|0.9||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, baseline PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 3||0.9|-15.0|0.0797
73889035|NCT03771664|147311245|SUPERIORITY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|4.24||0.1559|TWO_SIDED|95.0|-14.5|2.4||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, baseline PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 4||2.4|-14.5|0.1559
73889036|NCT03771664|147311246|SUPERIORITY||LS Mean Difference|15.8|STANDARD_ERROR_OF_MEAN|10.67||0.1441|TWO_SIDED|95.0|-5.5|37.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in overall TST||37.0|-5.5|0.1441
73889037|NCT03771664|147311246|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|5.47||0.3951|TWO_SIDED|95.0|-6.2|15.6||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 1||15.6|-6.2|0.3951
73889038|NCT03771664|147311246|SUPERIORITY||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|4.16||0.3705|TWO_SIDED|95.0|-4.5|12.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BLPSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 2||12.0|-4.5|0.3705
73889039|NCT03771664|147311246|SUPERIORITY||LS Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|4.04||0.1412|TWO_SIDED|95.0|-2.0|14.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 3||14.0|-2.0|0.1412
73889040|NCT03771664|147311246|SUPERIORITY||LS Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|4.24||0.1298|TWO_SIDED|95.0|-2.0|15.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 4||15.0|-2.0|0.1298
73889041|NCT03771664|147311247|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|7.87||0.7526|TWO_SIDED|95.0|-18.2|13.2||Change from BL in LPS was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||||13.2|-18.2|0.7526
73889042|NCT03771664|147311248|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.6769|TWO_SIDED|95.0|-2.0|1.3||Change from BL in NAW was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||||1.3|-2.0|0.6769
73889043|NCT03771664|147311249|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.7||0.0824|TWO_SIDED|95.0|-6.4|0.4||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in mean duration of awakenings (MDA) in total||0.4|-6.4|0.0824
73889044|NCT03771664|147311249|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.07||0.4269|TWO_SIDED|95.0|-3.0|1.3||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 1||1.3|-3.0|0.4269
73889045|NCT03771664|147311249|SUPERIORITY|Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|3.02||0.2482|TWO_SIDED|95.0|-9.5|2.5|||ANCOVA|||Change from BL in MDA in quarter 2||2.5|-9.5|0.2482
73889046|NCT03771664|147311249|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|3.34||0.3076|TWO_SIDED|95.0|-10.1|3.2||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 3||3.2|-10.1|0.3076
73889047|NCT03771664|147311249|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.68||0.4491|TWO_SIDED|95.0|-1.9|0.8||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 4||0.8|-1.9|0.4491
73889048|NCT03771664|147311250|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|2.47||0.8724|TWO_SIDED|95.0|-4.5|5.3||Change from BL in DS N1 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in duration of stage (DS) N1 sleep||5.3|-4.5|0.8724
73889049|NCT03771664|147311250|SUPERIORITY||LS Mean Difference|18.6|STANDARD_ERROR_OF_MEAN|8.08||0.0238|TWO_SIDED|95.0|2.5|34.7||Change from BL in DS N2 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in DS N2 sleep||34.7|2.5|0.0238
73889050|NCT03771664|147311250|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|5.62||0.3863|TWO_SIDED|95.0|-6.3|16.1||Change from BL in DS N3 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in DS N3 sleep||16.1|-6.3|0.3863
73889051|NCT03771664|147311250|SUPERIORITY||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|4.69||0.032|TWO_SIDED|95.0|-19.6|-0.9||Change from BL in REM sleep duration was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14(EODBT)\].|ANCOVA|||Change from BL in duration of REM sleep||-0.9|-19.6|0.0320
73889052|NCT03771664|147311251|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9524|TWO_SIDED|95.0|-1.7|1.6||Change from BL in PS N1 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score;Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in percentage of stage (PS) N1 sleep time||1.6|-1.7|0.9524
73889053|NCT03771664|147311251|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.55||0.093|TWO_SIDED|95.0|-0.5|5.7||Change from BL in PS N2 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in PS N2 sleep time||5.7|-0.5|0.0930
73889054|NCT03771664|147311251|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.52||0.4427|TWO_SIDED|95.0|-1.9|4.2||Change from BL in PS N3 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in PS N3 sleep time||4.2|-1.9|0.4427
73889055|NCT03771664|147311251|SUPERIORITY||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.06||0.0006|TWO_SIDED|95.0|-5.9|-1.7||Change from BL in % of REM sleep duration was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in percentage (%) of REM sleep time||-1.7|-5.9|0.0006
73889056|NCT03771664|147311252|SUPERIORITY||LS Mean Difference|33.7|STANDARD_ERROR_OF_MEAN|12.42||0.0083|TWO_SIDED|95.0|8.9|58.4||Change from BL in latency to first REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the first REM period||58.4|8.9|0.0083
73889057|NCT03771664|147311252|SUPERIORITY||LS Mean Difference|43.2|STANDARD_ERROR_OF_MEAN|10.95||0.0002|TWO_SIDED|95.0|21.3|65.0||Change from BL in latency to second REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the second REM period||65.0|21.3|0.0002
73889058|NCT03771664|147311252|SUPERIORITY||LS Mean Difference|38.2|STANDARD_ERROR_OF_MEAN|10.99||0.0009|TWO_SIDED|95.0|16.2|60.2||Change from BL in latency to third REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the third REM period||60.2|16.2|0.0009
73889059|NCT03771664|147311252|SUPERIORITY||LS Mean Difference|26.0|STANDARD_ERROR_OF_MEAN|14.84||0.0899|TWO_SIDED|95.0|-4.3|56.3||Change from BL in latency to fourth REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the fourth REM period||56.3|-4.3|0.0899
73889060|NCT03771664|147311253|SUPERIORITY||LS Mean Difference|-171.1|STANDARD_ERROR_OF_MEAN|46.06||0.0004|TWO_SIDED|95.0|-262.9|-79.4||Change from BL in REM density was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||||-79.4|-262.9|0.0004
73889061|NCT03771664|147311254|SUPERIORITY||LS Mean Difference|-288.0|STANDARD_ERROR_OF_MEAN|68.81|<|0.0001|TWO_SIDED|95.0|-425.1|-151.0||Change from BL in REMA was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, baseline PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||||-151.0|-425.1|<0.0001
73889062|NCT03771664|147311256|SUPERIORITY||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|14.65||0.4814|TWO_SIDED|95.0|-18.8|39.5||Change from BL in sTST was analyzed by Mixed Model Repeated Measures (MMRM) with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sTST||39.5|-18.8|0.4814
73889063|NCT03771664|147311256|SUPERIORITY||LS Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|6.45||0.0964|TWO_SIDED|95.0|-23.7|2.0||Change from BL in sWASO was analyzed by MMRM with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sWASO||2.0|-23.7|0.0964
73889064|NCT03771664|147311256|SUPERIORITY||LS Mean Difference|6.6|STANDARD_ERROR_OF_MEAN|7.32||0.3672|TWO_SIDED|95.0|-7.9|21.2||Change from BL in sSL was analyzed by MMRM with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sSL||21.2|-7.9|0.3672
73889065|NCT00561925|147311268|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -10%|Cochran's statistic|4.9|||<|0.0001||95.0|-0.1|10.0|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||10.0|-0.1|<0.0001
73889066|NCT00561925|147311270|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -2%|Cochran's statistic|4.84|||<|0.0001||95.0|-1.11|10.79|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||10.79|-1.11|<0.0001
73889067|NCT00561925|147311272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7719||95.0|-0.08|0.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum||||0.06|-0.08|0.7719
73889068|NCT00561925|147311273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.87||||0.0078||95.0|8.67|57.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum||||57.06|8.67|0.0078
73889069|NCT00561925|147311281|NON_INFERIORITY_OR_EQUIVALENCE|equivalence test with 80% -125% boundaries|adjusted gMean|79.58|STANDARD_ERROR_OF_MEAN|1.04||0.5542||90.0|74.62|84.86||p-value for ratio outside the interval 80%-125%|ANOVA||Inter-individual gCV = 49.9|adjusted geometric mean ratio NVP XR : NVP IR||84.86|74.62|0.5542
73889070|NCT05021978|147311287|OTHER|||||||0.1048||||||Change from baseline to Day 7 in TETRAS Upper Limb Score|Mixed Models Analysis|Includes timepoint as fixed effect and baseline TETRAS score as a covariate. Within subject variability modeled using unstructured covariance pattern.||Sample size is a convenience sample determined according to feasibility to provide sufficient and safety data to inform the development of future controlled studies with PRAX-944. In the open-label phase of the trial (Part A ), at least 10 participants would provide an 80% probability of observing at least 1 AE with an underlying incidence of 15% or greater and provide approximately 80% power to detect an effect size of 1.0 on the primary endpoint change from baseline in TETRAS Upper Limb score.||||0.1048
73889071|NCT05021978|147311287|OTHER|||||||0.0028||||||Change from baseline to Day 14 in TETRAS UL score|Mixed Models Analysis|||||||0.0028
73889072|NCT05021978|147311291|OTHER|||||||0.4025|||||||Mixed Models Analysis|Change from baseline to Day 7||||||0.4025
73889073|NCT05021978|147311291|OTHER|||||||0.0766||||||Change from baseline to Day 14|Mixed Models Analysis|||||||0.0766
73889074|NCT05021978|147311292|OTHER|||||||0.2501||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.2501
73889075|NCT05021978|147311292|OTHER|||||||0.1874||||||Chnage from baseline to Day 14|Mixed Models Analysis|||||||0.1874
73889076|NCT05021978|147311293|OTHER|||||||0.4722||||||Item 6 Archimedes Spiral (right) change from baseline to Day 7|Mixed Models Analysis|||||||0.4722
73889077|NCT05021978|147311293|OTHER|||||||0.6215||||||Item 6 Archimedes Spiral (left) change from baseline to Day 7|Mixed Models Analysis|||||||0.6215
73889078|NCT05021978|147311293|OTHER|||||||0.9648||||||Item 7 Handwriting change from baseline to Day 7|Mixed Models Analysis|||||||0.9648
73889079|NCT05021978|147311293|OTHER|||||||0.2855||||||Item 7 Handwriting change from baseline to Day 14|Mixed Models Analysis|||||||0.2855
73889080|NCT05021978|147311293|OTHER|||||||0.205||||||Item 6 Archimedes Spiral (right) change from baseline to Day 14|Mixed Models Analysis|||||||0.2050
73889081|NCT05021978|147311293|OTHER|||||||0.2364||||||Item 6 Archimedes Spiral (left) change from baseline to Day 14|Mixed Models Analysis|||||||0.2364
73889082|NCT05021978|147311297|OTHER|||||||0.0216|||||||Mixed Models Analysis|||||||0.0216
73889083|NCT05021978|147311298|OTHER|||||||0.1042||||||Change from baseline Day 7|Mixed Models Analysis|||||||0.1042
73889084|NCT05021978|147311298|OTHER|||||||0.0257||||||Change from baseline Day 21|Mixed Models Analysis|||||||0.0257
73889085|NCT05021978|147311299|OTHER|||||||0.2971||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.2971
73889086|NCT05021978|147311299|OTHER|||||||0.2034||||||Change from baseline Day 21|Mixed Models Analysis|||||||0.2034
73889087|NCT05021978|147311299|OTHER|||||||0.1105||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.1105
73889088|NCT05021978|147311300|OTHER|||||||0.005||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.0050
73889089|NCT05021978|147311300|OTHER|||||||0.0018||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0018
73889090|NCT05021978|147311300|OTHER|||||||0.0061||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0061
73889091|NCT05021978|147311301|OTHER|||||||0.9776||||||Item 6 Archimedes Spiral (right) change from baseline to Day 7|Mixed Models Analysis|||||||0.9776
73889092|NCT05021978|147311301|OTHER|||||||0.1962||||||Item 6 Archimedes Spiral (left) change from baseline to Day 7|Mixed Models Analysis|||||||0.1962
73889093|NCT05021978|147311301|OTHER|||||||0.9419||||||Item 7 Handwriting change from baseline to Day 7|Mixed Models Analysis|||||||0.9419
73889094|NCT05021978|147311301|OTHER|||||||0.0668||||||Item 6 Archimedes Spiral (right) change from baseline to Day 21|Mixed Models Analysis|||||||0.0668
73889095|NCT05021978|147311301|OTHER|||||||0.9191||||||Item 6 Archimedes Spiral (left) change from baseline to Day 21|Mixed Models Analysis|||||||0.9191
73889096|NCT05021978|147311301|OTHER|||||||0.6075||||||Item 7 Handwriting change from baseline to Day 21|Mixed Models Analysis|||||||0.6075
73889097|NCT05021978|147311301|OTHER|||||||0.246||||||Item 6 Archimedes Spiral (right) change from baseline to Day 42|Mixed Models Analysis|||||||0.2460
73889098|NCT05021978|147311301|OTHER|||||||0.6736||||||Item 6 Archimedes Spiral (left) change from baseline to Day 42|Mixed Models Analysis|||||||0.6736
73889099|NCT05021978|147311301|OTHER|||||||0.8511||||||Item 7 Handwriting change from baseline to Day 42|Mixed Models Analysis|||||||0.8511
73889100|NCT05021978|147311302|OTHER|||||||0.1505||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.1505
73889101|NCT05021978|147311302|OTHER|||||||0.0543||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0543
73889102|NCT05021978|147311302|OTHER|||||||0.0015||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0015
73889103|NCT05021978|147311303|OTHER|||||||0.8638||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.8638
73889104|NCT05021978|147311303|OTHER|||||||0.0605||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0605
73889105|NCT05021978|147311303|OTHER|||||||0.0871||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0871
73889106|NCT03096288|147311315|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.169|TWO_SIDED|95.0|-9.0|52.0|||t-test, 2 sided|||||52|-9|0.169
73889107|NCT03096288|147311315|SUPERIORITY||Median Difference (Final Values)|17.0||||0.236|TWO_SIDED|95.0|-11.0|45.0|||t-test, 2 sided|||||45|-11|0.236
73889108|NCT01782378|147311406|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.33|<|0.01|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.01
73889109|NCT01782378|147311407|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.88||0.88|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||0.88
73889110|NCT01782378|147311408|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.59||0.81|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||0.81
73889111|NCT01782378|147311409|SUPERIORITY||Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|2.88||0.23|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||0.23
73889112|NCT01782378|147311410|SUPERIORITY||Mean Difference (Final Values)|11.39|STANDARD_ERROR_OF_MEAN|7.08|<|0.12|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.12
73889113|NCT01782378|147311411|SUPERIORITY||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.93|<|0.52|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.52
73889114|NCT01782378|147311412|SUPERIORITY||Mean Difference (Final Values)|3.92|STANDARD_ERROR_OF_MEAN|3.51|<|0.27|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.27
73889115|NCT01782378|147311413|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|2.26|<|0.37|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.37
73889116|NCT01782378|147311414|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.78|<|0.36|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.36
73889117|NCT01782378|147311415|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.68|<|0.46|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.46
73889118|NCT01782378|147311416|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.83|<|0.84|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.84
73889119|NCT01782378|147311417|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.75|<|0.93|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.93
73889120|NCT01782378|147311418|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|3.02|<|0.85|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.85
73889121|NCT01782378|147311419|SUPERIORITY|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|Mean Difference (Final Values)|-14.43|STANDARD_ERROR_OF_MEAN|12.54|<|0.26|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results that were considered credible.||||||<0.26
73889122|NCT01782378|147311420|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.7|<|0.45|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.45
73889123|NCT01782378|147311421|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|1.18|<|0.46|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.46
73889124|NCT01782378|147311422|SUPERIORITY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.44|<|0.64|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.64
73889125|NCT01782378|147311423|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.63|<|0.82|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.82
73889126|NCT01782378|147311424|SUPERIORITY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|2.53|<|0.43|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.43
73889127|NCT01782378|147311425|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.62|<|0.15|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.15
73889128|NCT01782378|147311426|SUPERIORITY||Mean Difference (Final Values)|3.36|STANDARD_ERROR_OF_MEAN|1.86||0.08|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||.08
73889129|NCT01782378|147311427|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.83|<|0.7|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.7
73889130|NCT01782378|147311428|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.5|<|0.48|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.48
73889131|NCT01782378|147311429|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.16|<|0.02|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.02
73889132|NCT01782378|147311430|SUPERIORITY||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.19|<|0.36|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.36
73889133|NCT01782378|147311431|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.88|<|0.82|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.82
73889134|NCT01782378|147311432|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.84|<|0.2|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.2
73889135|NCT01782378|147311433|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.86|<|0.71|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.71
73889136|NCT01782378|147311434|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.73|<|0.85|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.85
73889137|NCT01782378|147311435|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.94|<|0.44|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.44
73889138|NCT02205736|147311443|SUPERIORITY|||||||0.8084||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 1 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.8084
73889139|NCT02205736|147311443|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 2 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
73889140|NCT02205736|147311443|SUPERIORITY|||||||0.0036||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 3 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0036
73889141|NCT02205736|147311443|SUPERIORITY|||||||0.0033||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 4 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0033
73889142|NCT02205736|147311443|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 5 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
73889143|NCT02205736|147311443|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 6 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
73889144|NCT02205736|147311443|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 7 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
73889145|NCT02205736|147311443|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 8 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
73889146|NCT02205736|147311443|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 9 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
73889147|NCT02205736|147311443|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 10 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
73889148|NCT02205736|147311443|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 11 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
73889149|NCT02205736|147311443|SUPERIORITY|||||||0.0124||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 12 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0124
73889150|NCT02205736|147311443|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 13 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
73889151|NCT02205736|147311443|SUPERIORITY|||||||0.0588||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 14 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0588
73889152|NCT02205736|147311443|SUPERIORITY|||||||0.0143||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 15 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0143
73889153|NCT02205736|147311443|SUPERIORITY|||||||0.1025||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 16 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.1025
73889154|NCT02205736|147311443|SUPERIORITY|||||||0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 17 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0001
73889155|NCT02205736|147311443|SUPERIORITY|||||||0.1138||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 18 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.1138
73889156|NCT02205736|147311443|SUPERIORITY|||||||0.0011||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 19 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0011
73889157|NCT02205736|147311443|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 20 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
73889158|NCT02205736|147311443|SUPERIORITY|||||||0.0522||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 21 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0522
73889159|NCT02205736|147311443|SUPERIORITY|||||||0.8185||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 22 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.8185
73889160|NCT02205736|147311443|SUPERIORITY|||||||0.0005||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 24 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0005
73889161|NCT02205736|147311443|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Subjects recorded True/False answers to Q25 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The contingency table of 329 responses to Q25 displayed the following: N=260 Correct at Baseline and Correct at Post-Intervention (79.0%), N=7 Correct at Baseline and Incorrect at Post-Intervention (2.1%), N=49 Incorrect at Baseline and Correct at Post-Intervention (14.9%), N=13 Incorrect at Baseline and Incorrect at Post-Intervention (4.0%).||||<.0001
73889162|NCT02205736|147311444|SUPERIORITY|||||||0.2482||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 1 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.2482
73889163|NCT02205736|147311444|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 2 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
73889164|NCT02205736|147311444|SUPERIORITY|||||||0.005||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 3 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0050
73889165|NCT02205736|147311444|SUPERIORITY|||||||0.0423||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 4 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0423
73889166|NCT02205736|147311444|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 5 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
73889167|NCT02205736|147311444|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 6 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
73889168|NCT02205736|147311444|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 7 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
73889169|NCT02205736|147311444|SUPERIORITY|||||||0.0002||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 8 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0002
73889170|NCT02205736|147311444|SUPERIORITY|||||||0.7456||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 9 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.7456
73889171|NCT02205736|147311444|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 10 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
73889172|NCT02205736|147311444|SUPERIORITY|||||||0.0028||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 11 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0028
73889173|NCT02205736|147311444|SUPERIORITY|||||||0.0707||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 12 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0707
73889174|NCT02205736|147311444|SUPERIORITY|||||||0.0026||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 13 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0026
73889175|NCT02205736|147311444|SUPERIORITY|||||||0.1797||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 14 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.1797
73889176|NCT02205736|147311444|SUPERIORITY|||||||0.6547||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 15 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.6547
73889177|NCT02205736|147311444|SUPERIORITY|||||||0.1797||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 16 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.1797
73889178|NCT02205736|147311444|SUPERIORITY|||||||0.285||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 17 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.2850
73889179|NCT02205736|147311444|SUPERIORITY|||||||0.0606||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 18 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0606
73889180|NCT02205736|147311444|SUPERIORITY|||||||0.0045||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 19 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0045
73889181|NCT02205736|147311444|SUPERIORITY|||||||0.9068||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 20 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.9068
73889182|NCT02205736|147311444|SUPERIORITY|||||||0.4142||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 21 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.4142
73889183|NCT02205736|147311444|SUPERIORITY|||||||0.5637||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 22 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.5637
73889184|NCT02205736|147311444|SUPERIORITY|||||||0.0002||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 23 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0002
73889185|NCT02205736|147311444|SUPERIORITY|||||||0.0196||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 24 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0196
73889186|NCT02205736|147311444|SUPERIORITY||||||<|0.0001||||||This outcome measure for Q25 was tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5% in the analyses of 25 questions.|McNemar|||Patients gave True/False responses to Question 25 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
73889187|NCT03173248|147311497|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.0011|TWO_SIDED|95.0|0.16|0.69||P-value is calculated from the one-sided log-rank test stratified by the randomization stratification factors (AML status and geographic region).|Log Rank||Hazard ratio is estimated using a Cox's proportional hazards model stratified by the randomization stratification factors (AML status and geographic region) with placebo + azacitidine as the denominator.|||0.69|0.16|0.0011
73889188|NCT01357850|147311655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0119||||0.7873|TWO_SIDED|95.0|-0.0768|0.1005|||ANOVA|||||0.1005|-0.0768|0.7873
73889189|NCT01357850|147311655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0678||||0.0499|TWO_SIDED|95.0|0.0|0.1356|||ANOVA|||||0.1356|0.0000|0.0499
73889190|NCT01357850|147311655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0467||||0.1666|TWO_SIDED|95.0|-0.0204|0.1137|||ANOVA|||||0.1137|-0.0204|0.1666
73889191|NCT01357850|147311656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|134.89||||0.9343|TWO_SIDED|95.0|-3172.05|3441.83|||ANOVA|||||3441.83|-3172.05|0.9343
73889192|NCT01357850|147311656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1278.77||||0.3375|TWO_SIDED|95.0|-1398.13|3955.68|||ANOVA|||||3955.68|-1398.13|0.3375
73889193|NCT01357850|147311656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|772.7||||0.5582|TWO_SIDED|95.0|-1887.77|3433.17|||ANOVA|||||3433.17|-1887.77|0.5582
73889194|NCT01357850|147311657|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.06||||0.2256|TWO_SIDED|95.0|-5.43|1.3|||ANOVA|||||1.30|-5.43|0.2256
73889195|NCT01357850|147311657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.5647|TWO_SIDED|95.0|-4.22|2.32|||ANOVA|||||2.32|-4.22|0.5647
73889196|NCT01357850|147311657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.8942|TWO_SIDED|95.0|-2.44|2.79|||ANOVA|||||2.79|-2.44|0.8942
73889197|NCT00753506|147311680|SUPERIORITY_OR_OTHER||F|1.59|||>|0.1|TWO_SIDED|95.0|||||ANOVA|||Repeated measures analaysis of variance||||>0.10
73889198|NCT03926611|147311691|SUPERIORITY|LOU064 10 mg q.d.|LS Mean|-13.66|STANDARD_ERROR_OF_MEAN|2.334|<|0.0001|TWO_SIDED|90.0|-17.51|-9.81|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-9.81|-17.51|<0.0001
73889199|NCT03926611|147311691|SUPERIORITY|LOU064 35 mg q.d.|LS Mean|-13.64|STANDARD_ERROR_OF_MEAN|2.336|<|0.0001|TWO_SIDED|90.0|-17.49|-9.78|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-9.78|-17.49|<0.0001
73889200|NCT03926611|147311691|SUPERIORITY|LOU064 100 mg q.d.|LS Mean|-9.21|STANDARD_ERROR_OF_MEAN|2.277|<|0.0001|TWO_SIDED|90.0|-12.97|-5.45|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.45|-12.97|<0.0001
73889201|NCT03926611|147311691|SUPERIORITY|LOU064 10 mg b.i.d.|LS Mean|-10.55|STANDARD_ERROR_OF_MEAN|2.319|<|0.0001|TWO_SIDED|90.0|-14.38|-6.72|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-6.72|-14.38|<0.0001
73889202|NCT03926611|147311691|SUPERIORITY|LOU064 25 mg b.i.d.|LS Mean|-14.58|STANDARD_ERROR_OF_MEAN|2.334|<|0.0001|TWO_SIDED|90.0|-18.43|-10.73|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-10.73|-18.43|<0.0001
73889203|NCT03926611|147311691|SUPERIORITY|LOU064 100 mg b.i.d.|LS Mean|-12.62|STANDARD_ERROR_OF_MEAN|2.327|<|0.0001|TWO_SIDED|90.0|-16.45|-8.78|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-8.78|-16.45|<0.0001
73889204|NCT03926611|147311692|SUPERIORITY|LOU064 10 mg q.d.|LS Mean|-10.24|STANDARD_ERROR_OF_MEAN|2.71|<|0.0001|TWO_SIDED|90.0|-14.72|-5.77|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.77|-14.72|<0.0001
73889205|NCT03926611|147311692|SUPERIORITY|LOU064 35 mg q.d.|LS Mean|-10.11|STANDARD_ERROR_OF_MEAN|2.711||0.0001|TWO_SIDED|90.0|-14.58|-5.63|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.63|-14.58|0.0001
73889206|NCT03926611|147311692|SUPERIORITY|LOU064 100 mg q.d.|LS Mean|-7.4|STANDARD_ERROR_OF_MEAN|2.635||0.0027|TWO_SIDED|90.0|-11.75|-3.05|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-3.05|-11.75|0.0027
73889207|NCT03926611|147311692|SUPERIORITY|LOU064 10 mg b.i.d.|LS Mean|-9.8|STANDARD_ERROR_OF_MEAN|2.696||0.0002|TWO_SIDED|90.0|-14.25|-5.35|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.35|-14.25|0.0002
73889208|NCT03926611|147311692|SUPERIORITY|LOU064 25 mg b.i.d.|LS Mean|-12.35|STANDARD_ERROR_OF_MEAN|2.714|<|0.0001|TWO_SIDED|90.0|-16.82|-7.87|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-7.87|-16.82|<0.0001
73889209|NCT03926611|147311692|SUPERIORITY|LOU064 100 mg b.i.d.|LS Mean|-9.52|STANDARD_ERROR_OF_MEAN|2.733||0.0003|TWO_SIDED|90.0|-14.03|-5.01|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.01|-14.03|0.0003
73889210|NCT02230670|147311712|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.0817||0.091|TWO_SIDED|95.0|-0.302|0.023|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.||0.023|-0.302|0.091
73889211|NCT02230670|147311712|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.041|TWO_SIDED|95.0|-0.41|0.01|||ANCOVA|||The analysis was conducted using an ANCOVA model adjusting for baseline value, baseline MELD score, and etiology. The significance was assessed using Type II Sums of Squares from this ANCOVA model.||0.01|-0.41|0.041
73889212|NCT02230670|147311713|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.333||0.466|TWO_SIDED|95.0|-0.91|0.42|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.||0.42|-0.91|0.466
73889213|NCT02230670|147311713|SUPERIORITY||Median Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|1.42||0.003|TWO_SIDED|95.0|-3.61|-0.77|||ANCOVA|calculated from the estimated least square means for the treatment by BL MELD category interaction term.||BL MELD \>= 15 subgroup results (N=19), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.||-0.77|-3.61|0.003
73889214|NCT02230670|147311713|SUPERIORITY||Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.46||0.029|TWO_SIDED|95.0|-3.09|-0.17|||ANCOVA|calculated from the estimated least square means for the treatment by etiology interaction term.||NASH Etiology subgroup results (N=20), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.||-0.17|-3.09|0.029
73889215|NCT02004093|147311755|SUPERIORITY_OR_OTHER|||||||0.3967|||||||Log Rank|||||||0.3967
73889216|NCT02004093|147311755|SUPERIORITY_OR_OTHER|||||||0.4552|||||||Wilcoxon (Mann-Whitney)|||||||0.4552
73889217|NCT02004093|147311755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.3972|TWO_SIDED|80.0|0.92|1.49||p-value resulting from Wald test of null hypothesis that the hazard ratio equals (=) 1|Wald test|||||1.49|0.92|0.3972
73889218|NCT02004093|147311756|SUPERIORITY_OR_OTHER||Difference in Response Rates|6.32||||0.3943|TWO_SIDED|80.0|-3.9|16.6|||Chi-squared|||||16.6|-3.9|0.3943
73889219|NCT02004093|147311756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|80.0|0.86|2.17|||||approximate 80% confidence interval (CI) for difference of two rates using Hauck-Anderson method|||2.17|0.86|
73889220|NCT02004093|147311757|SUPERIORITY_OR_OTHER|||||||0.3655|||||||Log Rank|||||||0.3655
73889221|NCT02004093|147311757|SUPERIORITY_OR_OTHER|||||||0.1319|||||||Wilcoxon (Mann-Whitney)|||||||0.1319
73889222|NCT02004093|147311757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.3679|TWO_SIDED|80.0|0.92|1.61|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.61|0.92|0.3679
73889223|NCT02004093|147311760|SUPERIORITY_OR_OTHER|||||||0.8129|||||||Log Rank|||||||0.8129
73889224|NCT02004093|147311760|SUPERIORITY_OR_OTHER|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||||||0.6920
73889225|NCT02004093|147311760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8137|TWO_SIDED|80.0|0.82|1.32|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.32|0.82|0.8137
73889226|NCT02004093|147311763|SUPERIORITY_OR_OTHER|||||||0.5726|||||||Log Rank|||||||0.5726
73889227|NCT02004093|147311763|SUPERIORITY_OR_OTHER|||||||0.3903|||||||Wilcoxon (Mann-Whitney)|||||||0.3903
73889228|NCT02004093|147311763|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.587|TWO_SIDED|80.0|0.87|1.43|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.43|0.87|0.5870
73889229|NCT02004093|147311765|SUPERIORITY_OR_OTHER|||||||0.9261|||||||Log Rank|||||||0.9261
73889230|NCT02004093|147311765|SUPERIORITY_OR_OTHER|||||||0.8591|||||||Wilcoxon (Mann-Whitney)|||||||0.8591
73889231|NCT02004093|147311765|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9262|TWO_SIDED|80.0|0.74|1.41||p-value resulting from Wald test of null hypothesis that the hazard ratio=1|Wald test|||||1.41|0.74|0.9262
73889232|NCT01411891|147311767|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.3|8.4||||||||8.4|0.3|
73889233|NCT01411891|147311768|SUPERIORITY||Risk Ratio (RR)|0.8||||0.65|TWO_SIDED|95.0|0.4|1.6|||Regression, Logistic|||||1.6|0.4|0.65
73889234|NCT00414596|147311769|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|The primary pain end-point was assessed by a mixed effect model with time (visit) and as fixed effects and subject as random effect.||"Hypothesis: Patients with chronic low back pain who undergo spinal decompression with a standardized 6-week regimen consisting of 20 treatments with the spinal decompression system would experience \>50% reduction in their verbal score of pain intensity.~Power Analysis: Mean pain scores at time of enrollment were assumed to equal 6 with potential reduction in pain of 50%. To obtain 80% power at an alpha level of 0.05, sample size was estimated as 20 patients."||||.0001
73889235|NCT02558296|147311775|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-0.48|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.39||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the primary endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.39|-0.56|<0.0001
73889236|NCT02558296|147311776|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.4||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories, history of heart failure, treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.40|-0.65|<0.0001
73889237|NCT02558296|147311777|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in body weight from baseline to Week 48 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.07|-2.24||P-value is presented based on one-sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline HbA1c and eGFR, history of heart failure, insulin use (Y/N), treatment, visit and baseline body weight as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in body weight from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-2.24|-3.07|<0.0001
73889238|NCT02558296|147311778|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in systolic blood pressure from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-2.96||||0.0112|TWO_SIDED|95.0|-5.51|-0.42||P-value is presented based on one-sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline HbA1c, GFR categories, BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline SBP as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in systolic blood pressure from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.42|-5.51|0.0112
73889239|NCT02558296|147311779|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 6 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.39||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 6 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.39|-0.50|<0.0001
73889240|NCT02558296|147311779|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 12 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.49||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 12 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.49|-0.63|<0.0001
73889241|NCT02558296|147311779|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.38|-0.56|<0.0001
73889242|NCT02558296|147311779|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 36 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 36 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.38|-0.56|<0.0001
73889243|NCT02558296|147311779|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 48 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.37||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.37|-0.56|<0.0001
73889244|NCT02558296|147311779|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 72 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.31||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 72 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.31|-0.54|<0.0001
73889245|NCT02558296|147311779|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 96 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.39|||<|0.0001|TWO_SIDED|95.0|-0.51|-0.27||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 96 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.27|-0.51|<0.0001
73889246|NCT02558296|147311779|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 120 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.43|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.3||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 120 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.30|-0.56|<0.0001
73889247|NCT02558296|147311779|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 144 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.23||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 144 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.23|-0.54|<0.0001
73889248|NCT02558296|147311779|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 168 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.27||||0.0045|TWO_SIDED|95.0|-0.47|-0.07||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 168 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.07|-0.47|0.0045
73889249|NCT02558296|147311780|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 6 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.55|-1.15||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 6 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.15|-1.55|<0.0001
73889250|NCT02558296|147311780|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 12 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.39|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.18||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 12 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.18|-1.61|<0.0001
73889251|NCT02558296|147311780|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 24 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.39|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.16||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.16|-1.61|<0.0001
73889252|NCT02558296|147311780|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 36 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.89||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 36 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.89|-1.41|<0.0001
73889253|NCT02558296|147311780|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 48 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.48|-0.98||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.98|-1.48|<0.0001
73889254|NCT02558296|147311780|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 72 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.72||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 72 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.72|-1.27|<0.0001
73889255|NCT02558296|147311780|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 96 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 96 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.90|-1.50|<0.0001
73889256|NCT02558296|147311780|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 120 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.49|-0.82||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 120 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.82|-1.49|<0.0001
73889257|NCT02558296|147311780|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 144 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.63||||0.0008|TWO_SIDED|95.0|-1.01|-0.24||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 144 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.24|-1.01|0.0008
73889258|NCT02558296|147311780|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 168 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.5||||0.0462|TWO_SIDED|95.0|-1.09|0.08||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 168 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||0.08|-1.09|0.0462
73889259|NCT02558296|147311781|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.41||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||0.41|0.22|<0.0001
73889260|NCT02558296|147311782|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.35|0.49||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for time to first event in the bexagliflozin arm vs. placebo arm during entire study.|||0.49|0.35|<0.0001
73889261|NCT02558296|147311783|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0005|TWO_SIDED|95.0|1.33|3.11||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the ratio of bexagliflozin over placebo.|||3.11|1.33|0.0005
73889262|NCT02558296|147311784|SUPERIORITY||Hazard Ratio (HR)|1.82|||<|0.0001|TWO_SIDED|95.0|1.4|2.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for time to first event in the bexagliflozin arm vs. placebo arm during the entire study.|||2.38|1.40|<0.0001
73889263|NCT02558296|147311785|SUPERIORITY||Odds Ratio (OR)|0.63||||0.0803|TWO_SIDED|95.0|0.33|1.2||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||1.20|0.33|0.0803
73889264|NCT02558296|147311785|SUPERIORITY||Odds Ratio (OR)|0.47||||0.0272|TWO_SIDED|95.0|0.22|1.01||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||1.01|0.22|0.0272
73889265|NCT02558296|147311785|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0757|TWO_SIDED|95.0|0.34|1.18||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for treatment comparison vs. placebo.|||1.18|0.34|0.0757
73889266|NCT02558296|147311785|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0273|TWO_SIDED|95.0|0.23|1.01||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for treatment comparison vs. placebo.|||1.01|0.23|0.0273
73889267|NCT00297258|147311786|SUPERIORITY_OR_OTHER||percentage of participants|46.0||||0.653||90.0|11.0|47.6|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||47.6|11.0|0.653
73889268|NCT00297258|147311786|SUPERIORITY_OR_OTHER||percentage of participants|41.0||||0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||55.5|28.4|0.003
73889269|NCT00297258|147311786|SUPERIORITY_OR_OTHER||percentage of participants|49.0|||<|0.001||90.0|34.3|63.2|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||63.2|34.3|<0.001
73889270|NCT00297258|147311786|SUPERIORITY_OR_OTHER||percentage of participants|41.0||||0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||55.5|28.4|0.003
73889271|NCT00346697|147311812|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73889272|NCT00346697|147311813|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||.80
73889273|NCT00346697|147311814|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
73889274|NCT00346697|147311815|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
73889275|NCT00346697|147311816|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
73889276|NCT00346697|147311817|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
73889277|NCT00346697|147311818|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
73889278|NCT00346697|147311819|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
73889279|NCT00346697|147311820|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
73889280|NCT00346697|147311821|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
73889281|NCT00346697|147311822|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
73889282|NCT00346697|147311823|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
73889283|NCT00346697|147311824|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
73889284|NCT00346697|147311825|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
73889285|NCT00346697|147311826|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
73889286|NCT00847210|147311839|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||There was no statistical significant difference (p-value \>0.05) in Tmax between the 30 mg and 60 mg dose group. Both age group and site did not have statistically significant effects on Tmax.|ANOVA|||This study was not powered for any hypothesis testing. For Tmax, an analysis of variance (ANOVA) model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||||0.095
73889287|NCT00847210|147311840|SUPERIORITY_OR_OTHER||ratio of the central values for Cmax|1.21||||0.289|TWO_SIDED|90.0|0.897|1.63|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole pharmacokinetics between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For natural logarithm of dose-normalized Cmax, an ANOVA model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. Site effect was tested in the model, and was not included in the final model if not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.630|0.897|0.289
73889288|NCT00847210|147311841|SUPERIORITY_OR_OTHER||Ratio of the dose-normalized AUC(0-tlqc)|1.158||||0.402|TWO_SIDED|90.0|0.864|1.551|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-tlqc) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.551|0.864|0.402
73889289|NCT00847210|147311842|SUPERIORITY_OR_OTHER||Ratio of the central values for dose-nor|1.168||||0.388|TWO_SIDED|90.0|0.864|1.579|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-24) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.579|0.864|0.388
73889290|NCT02504151|147311850|SUPERIORITY||Mean Difference (Net)|-0.284|STANDARD_ERROR_OF_MEAN|1.01||0.08|TWO_SIDED|95.0|-2.28|1.71|||Mixed Models Analysis|Linear mixed models was used with treatment, time and time\*treatment interaction in the model.|This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||1.71|-2.28|0.08
73889291|NCT02504151|147311851|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.48|TWO_SIDED|95.0|-0.12|0.07|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||0.07|-0.12|0.48
73889292|NCT02504151|147311852|SUPERIORITY||Mean Difference (Net)|-4.97|STANDARD_ERROR_OF_MEAN|2.47||0.485|TWO_SIDED|95.0|-9.87|-0.06|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||-0.06|-9.87|0.485
73889293|NCT02504151|147311853|SUPERIORITY||Mean Difference (Net)|4.13|STANDARD_ERROR_OF_MEAN|2.05||0.994|TWO_SIDED|95.0|0.07|8.19|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||8.19|0.07|0.994
73889294|NCT05038982|147311854|SUPERIORITY||Mean Difference (Net)|78.26|STANDARD_ERROR_OF_MEAN|16.15|<|0.001|TWO_SIDED|95.0|38.09|118.48||Threshold of significance at 0.05.|ANOVA||Percent PP-NRS reduction comparing subject's values at Week 0 to values at Week 12|||118.48|38.09|<0.001
73889295|NCT05038982|147311854|SUPERIORITY||Mean Difference (Net)|53.66|STANDARD_ERROR_OF_MEAN|18.12||0.0142|TWO_SIDED|95.0|8.55|98.76||Threshold of significance at 0.05.|ANOVA||Percent PP-NRS reduction comparing subject's values at Week 0 to values at Week 12|||98.76|8.55|0.0142
73889296|NCT05038982|147311856|SUPERIORITY||Mean Difference (Net)|9.4|STANDARD_ERROR_OF_MEAN|1.37||0.002|TWO_SIDED|95.0|6.3|12.5||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||12.5|6.3|0.002
73889297|NCT05038982|147311856|SUPERIORITY||Mean Difference (Net)|6.1|STANDARD_ERROR_OF_MEAN|1.99||0.0215|TWO_SIDED|95.0|1.6|10.6||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||10.6|1.6|0.0215
73889298|NCT05038982|147311857|SUPERIORITY||Mean Difference (Net)|10.1|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|5.9|14.3||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||14.3|5.9|0.002
73889299|NCT05038982|147311857|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|1.74||0.02|TWO_SIDED|95.0|0.77|8.6||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||8.6|0.77|0.02
73889300|NCT05038982|147311858|SUPERIORITY||Mean Difference (Net)|5.44|STANDARD_ERROR_OF_MEAN|1.21||0.0078|TWO_SIDED|95.0|2.7|8.18||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||8.18|2.70|0.0078
73889301|NCT05038982|147311859|SUPERIORITY||Mean Difference (Net)|12.73|STANDARD_ERROR_OF_MEAN|3.16||0.0098|TWO_SIDED|95.0|5.57|19.89||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||19.89|5.57|0.0098
73889302|NCT05038982|147311859|SUPERIORITY||Mean Difference (Net)|9.88|STANDARD_ERROR_OF_MEAN|3.0||0.0117|TWO_SIDED|95.0|3.1|16.66||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||16.66|3.10|0.0117
73889303|NCT05038982|147311860|SUPERIORITY||Mean Difference (Net)|10.2|STANDARD_ERROR_OF_MEAN|2.54||0.002|TWO_SIDED|95.0|4.46|15.94||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||15.94|4.46|0.002
73889304|NCT05038982|147311861|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.23||0.0078|TWO_SIDED|95.0|0.57|1.63||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||1.63|0.57|0.0078
73889305|NCT05038982|147311862|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.055||0.0391|TWO_SIDED|95.0|0.025|0.27||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||0.27|0.025|0.0391
73889306|NCT05038982|147311862|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.086||0.28|TWO_SIDED|95.0|-0.08|0.31||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||0.31|-.080|0.28
73889307|NCT05038982|147311863|SUPERIORITY||Mean Difference (Net)|3.6|STANDARD_ERROR_OF_MEAN|1.607||0.0684|TWO_SIDED|95.0|0.035|7.235||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||7.235|0.035|0.0684
73889308|NCT05038982|147311863|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.13||0.375|TWO_SIDED|95.0|-3.656|1.456||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||||1.456|-3.656|0.375
73889309|NCT05038982|147311864|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|1.212||0.207|TWO_SIDED|95.0|-3.44|2.04||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||2.04|-3.44|0.207
73889310|NCT05038982|147311864|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.498||0.8125|TWO_SIDED|95.0|-3.389|3.389||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||3.389|-3.389|0.8125
73889311|NCT05038982|147311865|SUPERIORITY||Mean Difference (Net)|4.8|STANDARD_ERROR_OF_MEAN|1.009||0.0039|TWO_SIDED|95.0|2.52|7.08||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||7.08|2.52|0.0039
73889312|NCT05038982|147311865|SUPERIORITY||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|1.033||0.0547|TWO_SIDED|95.0|-0.0376|4.638||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||4.638|-0.0376|0.0547
73889313|NCT05038982|147311866|SUPERIORITY||Mean Difference (Net)|9.0||||0.0003|TWO_SIDED|95.0|6.93|11.07||Threshold of significance at 0.05.|t-test, 2 sided|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||11.07|6.93|0.0003
73889314|NCT05038982|147311867|SUPERIORITY||Mean Difference (Net)|6.429|||<|0.0001|TWO_SIDED|95.0|4.011|8.846||Threshold of significance at 0.05.|t-test, 2 sided|||||8.846|4.011|<0.0001
73889315|NCT05038982|147311869|SUPERIORITY||Median Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.83|-0.33||Threshold of significance set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNA sequencing (RNASeq) performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.33|-0.83|<0.0001
73889316|NCT05038982|147311869|SUPERIORITY||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.091||0.0003|TWO_SIDED|95.0|-0.56|-0.18||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.18|-0.56|0.0003
73889317|NCT05038982|147311869|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.0952|TWO_SIDED|95.0|-0.47|0.039||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||0.039|-0.47|0.0952
73889318|NCT05038982|147311869|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.12||0.004|TWO_SIDED|95.0|-0.64|-0.13||Threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.13|-0.64|0.004
73889319|NCT05038982|147311869|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0277|TWO_SIDED|95.0|-0.81|-0.053||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at week 0.||-0.053|-0.81|0.0277
73889320|NCT05038982|147311869|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.077|TWO_SIDED|95.0|-0.85|0.049||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at week 12.||0.049|-0.85|0.077
73889321|NCT05038982|147311869|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.0363|TWO_SIDED|95.0|-0.64|-0.024||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.024|-0.64|0.0363
73889322|NCT05038982|147311869|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.1|TWO_SIDED|95.0|-0.63|0.062||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.062|-0.63|0.10
73889323|NCT05038982|147311869|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.15||0.0009|TWO_SIDED|95.0|-0.89|-0.27||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.27|-0.89|0.0009
73889324|NCT05038982|147311869|SUPERIORITY||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.2326|TWO_SIDED|95.0|-0.77|0.2||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.20|-0.77|0.2326
73889325|NCT05038982|147311869|SUPERIORITY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0047|TWO_SIDED|95.0|-0.85|-0.18||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.18|-0.85|0.0047
73889326|NCT05038982|147311869|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.0539|TWO_SIDED|95.0|-0.83|0.0076||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.0076|-0.83|0.0539
73889327|NCT00472576|147311898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.291|STANDARD_ERROR_OF_MEAN|0.693||0.001|TWO_SIDED|95.0|0.911|3.671|||Mixed Models Analysis||Mean differences reflect groups differences at end point.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz's Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.||3.671|0.911|.001
73889328|NCT00472576|147311899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|2.479||0.272|TWO_SIDED|95.0|-6.981|2.901||This test is a comparison of the MK-0657 condition to the placebo condition.|Mixed Models Analysis||The primary outcome of interest is whether the groups differ at the end of the study, so the means represent values at that point in time.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz's Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.||2.901|-6.981|.272
73889329|NCT02557139|147311904|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||Cmax null hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 48.00%|125.00|80.00|< 0.001
73889330|NCT02557139|147311904|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Geometric Means (%)|100.0||||0.23|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||Cmax null hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 48.00%|125.00|80.00|0.23
73889331|NCT02557139|147311905|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-inf) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 34.25%|125.00|80.00|<0.001
73889332|NCT02557139|147311905|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Adjusted Geometric Means (%)|100.0||||0.16|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-inf) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability;|125.00|80.00|0.16
73889333|NCT02557139|147311905|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-last) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability = 38.16%|125.00|80.00|< 0.001
73889334|NCT02557139|147311905|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Adjusted Geometric Means (%)|100.0||||0.18|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided||Intra-subject variability = 38.16%|AUC(0-last) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability = 38.16%|125.00|80.00|0.18
73889335|NCT02148874|147311931|SUPERIORITY||Odds Ratio (OR)|1.05||||0.84|TWO_SIDED|95.0|0.64|1.73|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1.||1.73|0.64|0.84
73889336|NCT02148874|147311931|SUPERIORITY||Odds Ratio (OR)|1.07||||0.79|TWO_SIDED|95.0|0.65|1.75|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.75|0.65|0.79
73889337|NCT02148874|147311931|SUPERIORITY||Odds Ratio (OR)|1.26||||0.43|TWO_SIDED|95.0|0.71|2.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Massachusetts||2.24|0.71|0.43
73889338|NCT02148874|147311931|SUPERIORITY||Odds Ratio (OR)|1.08||||0.77|TWO_SIDED|95.0|0.63|1.87|||Regression, Logistic||Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Brisbane||1.87|0.63|0.77
73889339|NCT02148874|147311932|SUPERIORITY||Odds Ratio (OR)|1.39||||0.2|TWO_SIDED|95.0|0.84|2.32|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1||2.32|0.84|0.20
73889340|NCT02148874|147311932|SUPERIORITY||Odds Ratio (OR)|1.09||||0.74|TWO_SIDED|95.0|0.66|1.8|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.80|0.66|0.74
73889341|NCT02148874|147311932|SUPERIORITY||Odds Ratio (OR)|1.89||||0.04|TWO_SIDED|95.0|1.04|3.44|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts||3.44|1.04|0.04
73889342|NCT02148874|147311932|SUPERIORITY||Odds Ratio (OR)|1.63||||0.13|TWO_SIDED|95.0|0.87|3.04|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane||3.04|0.87|0.13
73889343|NCT02148874|147311933|SUPERIORITY||Odds Ratio (OR)|0.89||||0.64|TWO_SIDED|95.0|0.53|1.48|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1||1.48|0.53|0.64
73889344|NCT02148874|147311933|SUPERIORITY||Odds Ratio (OR)|0.89||||0.67|TWO_SIDED|95.0|0.53|1.5|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.50|0.53|0.67
73889345|NCT02148874|147311933|SUPERIORITY||Odds Ratio (OR)|1.47||||0.14|TWO_SIDED|95.0|0.88|2.46|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts||2.46|0.88|0.14
73889346|NCT02148874|147311933|SUPERIORITY||Odds Ratio (OR)|0.74||||0.25|TWO_SIDED|95.0|0.44|1.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane||1.24|0.44|0.25
73889347|NCT02592798|147311934|SUPERIORITY||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-46.8|33.3|||||Abatacept - Placebo for Double-Blind Period Day 113|||33.3|-46.8|
73889348|NCT02592798|147311934|SUPERIORITY||Mean Difference (Final Values)|-20.8|||||TWO_SIDED|95.0|-63.3|24.3|||||Abatacept - Placebo for Open Label Period Day 113|||24.3|-63.3|
73889349|NCT02592798|147311935|SUPERIORITY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|95.0|-1.6495|2.3855|||||Abatacept - Placebo for Double-Blind Period Day 113|||2.3855|-1.6495|
73889350|NCT02592798|147311935|SUPERIORITY||Mean Difference (Final Values)|1.95|||||TWO_SIDED|95.0|-1.7933|5.6954|||||Abatacept - Placebo for Open Label Period Day 113|||5.6954|-1.7933|
73889351|NCT02592798|147311936|SUPERIORITY||Mean Difference (Final Values)|0.13|||||TWO_SIDED|95.0|-0.1483|0.4119|||||Abatacept - Placebo for Double-Blind Period Day 113|||0.4119|-0.1483|
73889352|NCT02592798|147311936|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.5107|0.7551|||||Abatacept - Placebo for Open Label Period Day 113|||0.7551|-0.5107|
73889353|NCT02592798|147311937|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-44.7|44.7|||||Abatacept - Placebo for Open Label Period Day 113|||44.7|-44.7|
73889354|NCT02592798|147311938|SUPERIORITY||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-8.1395|6.7645|||||Abatacept - Placebo for Fatigue|||6.7645|-8.1395|
73889355|NCT02592798|147311938|SUPERIORITY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-13.9402|6.5402|||||Abatacept - Placebo for Pain interference|||6.5402|-13.9402|
73889356|NCT02592798|147311938|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-6.5736|4.5736|||||Abatacept - Placebo for Physical function|||4.5736|-6.5736|
73889357|NCT02592798|147311939|SUPERIORITY||Mean Difference (Final Values)|12.45|||||TWO_SIDED|95.0|-4.595|29.485|||||Abatacept - Placebo for Fatigue|||29.4850|-4.5950|
73889358|NCT02592798|147311939|SUPERIORITY||Mean Difference (Final Values)|7.14|||||TWO_SIDED|95.0|-2.5917|16.8717|||||Abatacept - Placebo for Pain interference|||16.8717|-2.5917|
73889359|NCT02592798|147311939|SUPERIORITY||Mean Difference (Final Values)|-0.88|||||TWO_SIDED|95.0|-12.1068|10.3468|||||Abatacept - Placebo for Mobility|||10.3468|-12.1068|
73889360|NCT00705016|147311948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.885|TWO_SIDED|95.0|0.67|1.59||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) \<80/\>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log Hazard ratio (HR), if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.||1.59|0.67|0.885
73889361|NCT00705016|147311948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.55||||0.054|TWO_SIDED|95.0|0.99|2.43||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) \<80/\>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log HR, if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.||2.43|0.99|0.054
73889362|NCT00705016|147311949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8|TWO_SIDED|95.0|0.61|1.47||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||1.47|0.61|0.800
73889363|NCT00705016|147311949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.878|TWO_SIDED|95.0|0.66|1.63|||Cox proportional hazards model|||||1.63|0.66|0.878
73889364|NCT00705016|147311950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.595||||0.205|TWO_SIDED|95.0|0.776|3.276||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||3.276|0.776|0.205
73889365|NCT00705016|147311950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.671||||0.317|TWO_SIDED|95.0|0.307|1.465||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||1.465|0.307|0.317
73889366|NCT00705016|147311951|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.396||||0.476|TWO_SIDED|95.0|0.551|3.539||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||3.539|0.551|0.476
73889367|NCT00705016|147311951|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.668||||0.347|TWO_SIDED|95.0|0.287|1.555||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||1.555|0.287|0.347
73889368|NCT00705016|147311952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.294|TWO_SIDED|95.0|0.84|1.81||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||1.81|0.84|0.294
73889369|NCT00705016|147311952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73||||0.007|TWO_SIDED|95.0|1.16|2.57||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||2.57|1.16|0.007
73889370|NCT00705016|147311953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.391|TWO_SIDED|95.0|0.71|2.39||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||2.39|0.71|0.391
73889371|NCT00705016|147311953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6||||0.007|TWO_SIDED|95.0|1.3|5.21||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||5.21|1.30|0.007
73889372|NCT02233517|147311955|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.84|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.84
73889373|NCT02233517|147311955|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.52|<|0.44|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||<0.44
73889374|NCT02233517|147311955|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.33|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.33
73889375|NCT02233517|147311956|SUPERIORITY|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.1||0.26|TWO_SIDED||||||Mixed Models Analysis|||Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on DAR scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.||||0.26
73889376|NCT02233517|147311957|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|1.16||0.9|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.90
73889377|NCT02233517|147311957|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|1.16||0.85|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.85
73889378|NCT02233517|147311957|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|1.16||0.79|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.79
73889379|NCT02233517|147311958|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_DEVIATION|3.2||0.05|TWO_SIDED|95.0|-4.5|-0.002|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Extent of Participation scale.||-.002|-4.5|0.05
73889380|NCT02233517|147311958|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|2.09||0.53|TWO_SIDED|95.0|-2.03|1.08|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Perceived Limitations scale.||1.08|-2.03|0.53
73889381|NCT02233517|147311958|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_DEVIATION|2.42||0.5|TWO_SIDED|95.0|-2.3|1.14|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Satisfaction scale.||1.14|-2.30|0.50
73889382|NCT02233517|147311959|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED||||||Mixed Models Analysis||The estimation parameter of 0.28 indicates that at each of the 16 time points, participants in the CBT arm had 0.28 point less of a decrease in disability than those in PCT arm.|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).||||<0.0001
73889383|NCT02233517|147311960|SUPERIORITY||Mean Difference (Net)|1.45|STANDARD_ERROR_OF_MEAN|2.71||0.59|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.59
73889384|NCT02233517|147311960|SUPERIORITY||Mean Difference (Net)|1.37|STANDARD_ERROR_OF_MEAN|2.71||0.61|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.61
73889385|NCT02233517|147311960|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|2.71||0.74|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.74
73889386|NCT02233517|147311961|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.25|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.25
73889387|NCT02233517|147311961|SUPERIORITY||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.16||0.97|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.97
73889388|NCT02233517|147311961|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.69|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.69
73889389|NCT02233517|147311962|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.66||0.29|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.29
73889390|NCT02233517|147311962|SUPERIORITY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.66||0.44|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.44
73889391|NCT02233517|147311962|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.66||0.11|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.11
73889392|NCT02233517|147311963|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.12||0.16|TWO_SIDED||||||Mixed Models Analysis||Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in PTSD in PCT).|Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on PCL Total scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.||||0.16
73889393|NCT02233517|147311964|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.37||0.45|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.45
73889394|NCT02233517|147311964|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.37||0.55|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.55
73889395|NCT02233517|147311964|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.37||0.87|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.87
73889396|NCT02233517|147311965|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|1.04||0.49|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment.|||||0.49
73889397|NCT02233517|147311965|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|1.04||0.7|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.70
73889398|NCT02233517|147311965|SUPERIORITY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.04||0.45|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.45
73889399|NCT01721044|147311989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
73889400|NCT01721044|147311990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
73889401|NCT01721044|147311991|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
73889402|NCT01721044|147311992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.140
73889403|NCT01721044|147311993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
73889404|NCT01721044|147311994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
73889405|NCT01721044|147311995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
73889406|NCT01721044|147311996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.723|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.723
73889407|NCT01721044|147311997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided \<=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
73889408|NCT01721044|147311997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided \<=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
73889409|NCT01721044|147311998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.001
73889410|NCT01721044|147311998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.002
73889411|NCT01721044|147311998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
73889412|NCT01721044|147311998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.015
73889413|NCT01721044|147311999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.002
73889414|NCT01721044|147311999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.001
73889415|NCT01721044|147311999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
73889416|NCT01721044|147311999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
73889417|NCT01721044|147312000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
73889418|NCT01721044|147312000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
73889419|NCT01721044|147312001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
73889420|NCT01721044|147312001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.009
73889421|NCT01721044|147312002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
73889422|NCT01721044|147312002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.003
73889423|NCT01721044|147312003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.012
73889424|NCT01721044|147312003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.104
73889425|NCT01721044|147312004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)|||||||0.002
73889426|NCT01721044|147312004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)|||||||0.004
73889427|NCT01721044|147312005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
73889428|NCT01721044|147312005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.018
73889429|NCT01721044|147312006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
73889430|NCT01721044|147312006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
73889431|NCT01721044|147312007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12||||0.005
73889432|NCT01721044|147312007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12||||0.004
73889433|NCT01721044|147312007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24||||0.002
73889434|NCT01721044|147312007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24||||0.026
73889435|NCT01721044|147312008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.448|TWO_SIDED||||||ANCOVA|||MCS Week 12||||0.448
73889436|NCT01721044|147312008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED||||||ANCOVA|||MCS Week 12||||0.058
73889437|NCT01721044|147312008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446|TWO_SIDED||||||ANCOVA|||MCS Week 24||||0.446
73889438|NCT01721044|147312008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.401|TWO_SIDED||||||ANCOVA|||MCS Week 24||||0.401
73889439|NCT01721044|147312008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 12||||0.001
73889440|NCT01721044|147312008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 12||||0.001
73889441|NCT01721044|147312008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 24||||0.001
73889442|NCT01721044|147312008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 24||||0.001
73889443|NCT01721044|147312009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm||||0.001
73889444|NCT01721044|147312009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm||||0.001
73889445|NCT01721044|147312009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm||||0.001
73889446|NCT01721044|147312009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm||||0.003
73889447|NCT01721044|147312009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm||||0.001
73889448|NCT01721044|147312009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm||||0.001
73889449|NCT01721044|147312009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm||||0.001
73889450|NCT01721044|147312009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm||||0.002
73889451|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362|TWO_SIDED||||||ANCOVA|||Absenteeism Week 12||||0.362
73889452|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED||||||ANCOVA|||Absenteeism Week 12||||0.170
73889453|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753|TWO_SIDED||||||ANCOVA|||Absenteeism Week 24||||0.753
73889454|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.715|TWO_SIDED||||||ANCOVA|||Absenteeism Week 24||||0.715
73889455|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077|TWO_SIDED||||||ANCOVA|||Presenteeism Week 12||||0.077
73889456|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED||||||ANCOVA|||Presenteeism Week 12||||0.058
73889457|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.232|TWO_SIDED||||||ANCOVA|||Presenteeism Week 24||||0.232
73889458|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.534|TWO_SIDED||||||ANCOVA|||Presenteeism Week 24||||0.534
73889459|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 12||||0.079
73889460|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 12||||0.070
73889461|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 24||||0.327
73889462|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.479|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 24||||0.479
73889463|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 12||||0.001
73889464|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 12||||0.005
73889465|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 24||||0.001
73889466|NCT01721044|147312010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 24||||0.030
73889467|NCT02048670|147312013|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||Condition 1 - eyes open, visual surround locked, platform locked||||0.005
73889468|NCT02048670|147312013|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||Condition 2 - eyes closed, visual surround locked, platform locked||||0.006
73889469|NCT02048670|147312013|SUPERIORITY|||||||0.051|||||||Kruskal-Wallis|||Condition 3 - eyes open, visual surround unlocked, platform locked||||0.051
73889470|NCT02048670|147312013|SUPERIORITY|||||||0.173|||||||Kruskal-Wallis|||Condition 4 - eyes open, visual surround locked, platform unlocked||||0.173
73889471|NCT02048670|147312013|SUPERIORITY|||||||0.985|||||||Kruskal-Wallis|||Condition 5 - eyes closed, visual surround locked, platform unlocked||||0.985
73889472|NCT02048670|147312013|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||Condition 6 - eyes open, visual surround unlocked, platform unlocked||||0.003
73889473|NCT04032093|147312023|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
73889474|NCT04032093|147312023|OTHER||Geometric Mean Ratio|20.0|||||TWO_SIDED|95.0|16.1|24.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||24.7|16.1|
73889475|NCT04032093|147312023|OTHER||Geometric Mean Ratio|15.6|||||TWO_SIDED|95.0|11.9|20.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||20.4|11.9|
73889476|NCT04032093|147312023|OTHER||Geometric Mean Ratio|11.2|||||TWO_SIDED|95.0|8.7|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||14.5|8.7|
73889477|NCT04032093|147312023|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.9|
73889478|NCT04032093|147312023|OTHER||Geometric Mean Ratio|24.2|||||TWO_SIDED|95.0|18.5|31.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||31.7|18.5|
73889479|NCT04032093|147312023|OTHER||Geometric Mean Ratio|20.4|||||TWO_SIDED|95.0|15.7|26.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||26.6|15.7|
73889480|NCT04032093|147312023|OTHER||Geometric Mean Ratio|13.6|||||TWO_SIDED|95.0|10.1|18.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||18.4|10.1|
73889481|NCT04032093|147312023|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
73889482|NCT04032093|147312023|OTHER||Geometric Mean Ratio|19.8|||||TWO_SIDED|95.0|15.3|25.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||25.7|15.3|
73889483|NCT04032093|147312023|OTHER||Geometric Mean Ratio|20.0|||||TWO_SIDED|95.0|15.9|25.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||25.1|15.9|
73889484|NCT04032093|147312023|OTHER||Geometric Mean Ratio|15.0|||||TWO_SIDED|95.0|11.9|18.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||18.9|11.9|
73889485|NCT04032093|147312023|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.8|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.8|
73889486|NCT04032093|147312023|OTHER||Geometric Mean Ratio|22.5|||||TWO_SIDED|95.0|16.9|30.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||30.1|16.9|
73889487|NCT04032093|147312023|OTHER||Geometric Mean Ratio|22.5|||||TWO_SIDED|95.0|17.6|28.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||28.7|17.6|
73889488|NCT04032093|147312023|OTHER||Geometric Mean Ratio|16.8|||||TWO_SIDED|95.0|12.7|22.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||22.3|12.7|
73889489|NCT04032093|147312023|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.2|0.8|
73889490|NCT04032093|147312023|OTHER||Geometric Mean Ratio|21.0|||||TWO_SIDED|95.0|16.6|26.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||26.5|16.6|
73889491|NCT04032093|147312023|OTHER||Geometric Mean Ratio|15.3|||||TWO_SIDED|95.0|11.6|20.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||20.1|11.6|
73889492|NCT04032093|147312023|OTHER||Geometric Mean Ratio|10.6|||||TWO_SIDED|95.0|8.1|14.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||14.0|8.1|
73889493|NCT04032093|147312023|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.8|
73889494|NCT04032093|147312023|OTHER||Geometric Mean Ratio|26.6|||||TWO_SIDED|95.0|20.5|34.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||34.6|20.5|
73889495|NCT04032093|147312023|OTHER||Geometric Mean Ratio|18.0|||||TWO_SIDED|95.0|13.5|24.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||24.1|13.5|
73889496|NCT04032093|147312023|OTHER||Geometric Mean Ratio|13.5|||||TWO_SIDED|95.0|10.1|18.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||18.0|10.1|
73889497|NCT04032093|147312023|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
73889498|NCT04032093|147312023|OTHER||Geometric Mean Ratio|25.0|||||TWO_SIDED|95.0|19.9|31.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||31.3|19.9|
73889499|NCT04032093|147312023|OTHER||Geometric Mean Ratio|18.1|||||TWO_SIDED|95.0|14.5|22.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||22.8|14.5|
73889500|NCT04032093|147312023|OTHER||Geometric Mean Ratio|13.8|||||TWO_SIDED|95.0|10.8|17.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||17.5|10.8|
73889501|NCT04032093|147312023|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.4|0.9|
73889502|NCT04032093|147312023|OTHER||Geometric Mean Ratio|34.7|||||TWO_SIDED|95.0|27.0|44.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||44.4|27.0|
73889503|NCT04032093|147312023|OTHER||Geometric Mean Ratio|23.2|||||TWO_SIDED|95.0|18.2|29.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||29.6|18.2|
73889504|NCT04032093|147312023|OTHER||Geometric Mean Ratio|16.2|||||TWO_SIDED|95.0|12.0|21.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||21.7|12.0|
73889505|NCT04032093|147312025|OTHER||Geometric Mean Ratio|10.7|||||TWO_SIDED|95.0|8.1|14.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.1|8.1|
73889506|NCT04032093|147312025|OTHER||Geometric Mean Ratio|8.9|||||TWO_SIDED|95.0|5.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.5|5.5|
73889507|NCT04032093|147312025|OTHER||Geometric Mean Ratio|15.8|||||TWO_SIDED|95.0|10.7|23.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||23.4|10.7|
73889508|NCT04032093|147312025|OTHER||Geometric Mean Ratio|5.6|||||TWO_SIDED|95.0|3.5|9.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||9.0|3.5|
73889509|NCT04032093|147312025|OTHER||Geometric Mean Ratio|6.6|||||TWO_SIDED|95.0|4.5|9.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||9.6|4.5|
73889510|NCT04032093|147312025|OTHER||Geometric Mean Ratio|14.9|||||TWO_SIDED|95.0|11.1|19.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||19.9|11.1|
73889511|NCT04032093|147312025|OTHER||Geometric Mean Ratio|11.0|||||TWO_SIDED|95.0|6.5|18.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||18.6|6.5|
73889512|NCT04032093|147312025|OTHER||Geometric Mean Ratio|19.2|||||TWO_SIDED|95.0|13.1|28.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||28.0|13.1|
73889513|NCT04032093|147312025|OTHER||Geometric Mean Ratio|6.9|||||TWO_SIDED|95.0|4.2|11.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||11.4|4.2|
73889514|NCT04032093|147312025|OTHER||Geometric Mean Ratio|7.3|||||TWO_SIDED|95.0|4.5|11.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||11.8|4.5|
73889515|NCT04032093|147312025|OTHER||Geometric Mean Ratio|10.8|||||TWO_SIDED|95.0|8.3|14.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.2|8.3|
73889516|NCT04032093|147312025|OTHER||Geometric Mean Ratio|9.7|||||TWO_SIDED|95.0|6.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.5|6.5|
73889517|NCT04032093|147312025|OTHER||Geometric Mean Ratio|10.6|||||TWO_SIDED|95.0|7.1|15.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||15.9|7.1|
73889518|NCT04032093|147312025|OTHER||Geometric Mean Ratio|8.2|||||TWO_SIDED|95.0|5.2|12.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||12.9|5.2|
73889519|NCT04032093|147312025|OTHER||Geometric Mean Ratio|4.8|||||TWO_SIDED|95.0|3.1|7.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||7.5|3.1|
73889520|NCT04032093|147312025|OTHER||Geometric Mean Ratio|14.0|||||TWO_SIDED|95.0|10.5|18.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||18.7|10.5|
73889521|NCT04032093|147312025|OTHER||Geometric Mean Ratio|11.8|||||TWO_SIDED|95.0|7.4|18.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||18.7|7.4|
73889522|NCT04032093|147312025|OTHER||Geometric Mean Ratio|11.9|||||TWO_SIDED|95.0|7.7|18.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||18.3|7.7|
73889523|NCT04032093|147312025|OTHER||Geometric Mean Ratio|8.9|||||TWO_SIDED|95.0|5.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||14.5|5.5|
73889524|NCT04032093|147312025|OTHER||Geometric Mean Ratio|5.4|||||TWO_SIDED|95.0|3.3|8.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||8.8|3.3|
73889525|NCT04032093|147312025|OTHER||Geometric Mean Ratio|9.5|||||TWO_SIDED|95.0|7.4|12.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||12.3|7.4|
73889526|NCT04032093|147312025|OTHER||Geometric Mean Ratio|8.4|||||TWO_SIDED|95.0|5.7|12.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||12.4|5.7|
73889527|NCT04032093|147312025|OTHER||Geometric Mean Ratio|9.9|||||TWO_SIDED|95.0|6.4|15.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||15.4|6.4|
73889528|NCT04032093|147312025|OTHER||Geometric Mean Ratio|4.5|||||TWO_SIDED|95.0|2.9|6.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||6.8|2.9|
73889529|NCT04032093|147312025|OTHER||Geometric Mean Ratio|4.0|||||TWO_SIDED|95.0|2.5|6.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||6.3|2.5|
73889530|NCT04032093|147312025|OTHER||Geometric Mean Ratio|12.4|||||TWO_SIDED|95.0|9.2|16.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||16.6|9.2|
73889531|NCT04032093|147312025|OTHER||Geometric Mean Ratio|11.3|||||TWO_SIDED|95.0|7.1|17.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||17.9|7.1|
73889532|NCT04032093|147312025|OTHER||Geometric Mean Ratio|10.4|||||TWO_SIDED|95.0|7.0|15.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||15.2|7.0|
73889533|NCT04032093|147312025|OTHER||Geometric Mean Ratio|5.7|||||TWO_SIDED|95.0|3.7|9.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||9.0|3.7|
73889534|NCT04032093|147312025|OTHER||Geometric Mean Ratio|4.3|||||TWO_SIDED|95.0|2.7|7.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||7.0|2.7|
73889535|NCT04032093|147312025|OTHER||Geometric Mean Ratio|11.3|||||TWO_SIDED|95.0|8.6|14.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.9|8.6|
73889536|NCT04032093|147312025|OTHER||Geometric Mean Ratio|10.2|||||TWO_SIDED|95.0|7.4|14.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.0|7.4|
73889537|NCT04032093|147312025|OTHER||Geometric Mean Ratio|15.0|||||TWO_SIDED|95.0|10.2|22.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||22.1|10.2|
73889538|NCT04032093|147312025|OTHER||Geometric Mean Ratio|6.1|||||TWO_SIDED|95.0|3.9|9.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||9.6|3.9|
73889539|NCT04032093|147312025|OTHER||Geometric Mean Ratio|4.5|||||TWO_SIDED|95.0|2.9|6.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||6.9|2.9|
73889540|NCT04032093|147312025|OTHER||Geometric Mean Ratio|16.2|||||TWO_SIDED|95.0|12.5|21.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||21.2|12.5|
73889541|NCT04032093|147312025|OTHER||Geometric Mean Ratio|12.8|||||TWO_SIDED|95.0|8.6|19.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||19.1|8.6|
73889542|NCT04032093|147312025|OTHER||Geometric Mean Ratio|17.7|||||TWO_SIDED|95.0|11.9|26.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||26.2|11.9|
73889543|NCT04032093|147312025|OTHER||Geometric Mean Ratio|9.0|||||TWO_SIDED|95.0|5.7|14.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||14.4|5.7|
73889544|NCT04032093|147312025|OTHER||Geometric Mean Ratio|6.2|||||TWO_SIDED|95.0|3.9|9.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||9.9|3.9|
73889545|NCT02839200|147312052|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all ACT-541468 doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"||||<0.001
73889546|NCT02839200|147312052|OTHER||LS mean difference|-7.0|STANDARD_ERROR_OF_MEAN|5.95||0.241|TWO_SIDED|95.0|-18.7|4.7|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||4.7|-18.7|0.241
73889547|NCT02839200|147312052|OTHER||LS Mean difference|-10.8|STANDARD_ERROR_OF_MEAN|6.0||0.072|TWO_SIDED|95.0|-22.6|1.0|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||1|-22.6|0.072
73889548|NCT02839200|147312052|OTHER||LS Mean difference|-16.2|STANDARD_ERROR_OF_MEAN|5.95||0.007|TWO_SIDED|95.0|-27.9|-4.5|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||-4.5|-27.9|0.007
73889549|NCT02839200|147312052|OTHER||LS Mean difference|-25.6|STANDARD_ERROR_OF_MEAN|5.92|<|0.001|TWO_SIDED|95.0|-37.3|-13.9|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||-13.9|-37.3|< 0.001
73889550|NCT02839200|147312052|OTHER||LS Mean difference|-8.5|STANDARD_ERROR_OF_MEAN|5.97||0.155|TWO_SIDED|95.0|-20.4|3.3|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||3.3|-20.4|0.155
73889551|NCT02952820|147312056|SUPERIORITY||least squares geometric mean (LSGM)ratio|0.732|||<|0.0001|TWO_SIDED|95.0|0.636|0.843|||Mixed Models Analysis|||Analysis was based on mixed effect model repeated measurement analysis (MMRM) model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (missing not at random/complete case missing value \[MNAR/CCMV\]).||0.843|0.636|<.0001
73889552|NCT02952820|147312056|SUPERIORITY||LSGM ratio|0.701|||<|0.0001|TWO_SIDED|95.0|0.607|0.81|||Mixed Models Analysis|||Analysis was based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.810|0.607|<.0001
73889553|NCT02952820|147312057|SUPERIORITY||LSGM ratio|0.781|||<|0.0001|TWO_SIDED|95.0|0.725|0.842|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 1): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.842|0.725|<.0001
73889554|NCT02952820|147312057|SUPERIORITY||LSGM ratio|0.752|||<|0.0001|TWO_SIDED|95.0|0.698|0.811|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.811|0.698|<.0001
73889555|NCT02952820|147312057|SUPERIORITY||LSGM ratio|0.81|||<|0.0001|TWO_SIDED|95.0|0.735|0.893|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.893|0.735|<.0001
73889556|NCT02952820|147312057|SUPERIORITY||LSGM ratio|0.77|||<|0.0001|TWO_SIDED|95.0|0.698|0.848|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.848|0.698|<.0001
73889557|NCT02952820|147312057|SUPERIORITY||LSGM ratio|0.778|||<|0.0001|TWO_SIDED|95.0|0.69|0.878|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.878|0.690|<.0001
73889558|NCT02952820|147312057|SUPERIORITY||LSGM ratio|0.77|||<|0.0001|TWO_SIDED|95.0|0.681|0.869|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.869|0.681|<.0001
73889559|NCT02952820|147312058|SUPERIORITY||LSM Difference|4.299|STANDARD_ERROR_OF_MEAN|0.848|<|0.0001|TWO_SIDED|95.0|2.638|5.961|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||5.961|2.638|<.0001
73889560|NCT02952820|147312058|SUPERIORITY||LSM Difference|5.793|STANDARD_ERROR_OF_MEAN|0.846|<|0.0001|TWO_SIDED|95.0|4.133|7.452|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||7.452|4.133|<.0001
73889561|NCT02952820|147312058|SUPERIORITY||LSM Difference|2.227|STANDARD_ERROR_OF_MEAN|0.979||0.023|TWO_SIDED|95.0|0.307|4.146|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||4.146|0.307|0.0230
73889562|NCT02952820|147312058|SUPERIORITY||LSM Difference|3.615|STANDARD_ERROR_OF_MEAN|1.01||0.0003|TWO_SIDED|95.0|1.635|5.595|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||5.595|1.635|0.0003
73889563|NCT02952820|147312058|SUPERIORITY||LSM Difference|4.222|STANDARD_ERROR_OF_MEAN|1.099||0.0001|TWO_SIDED|95.0|2.068|6.377|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.377|2.068|0.0001
73889564|NCT02952820|147312058|SUPERIORITY||LSM Difference|4.361|STANDARD_ERROR_OF_MEAN|1.092|<|0.0001|TWO_SIDED|95.0|2.22|6.501|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.501|2.220|<.0001
73889565|NCT02952820|147312058|SUPERIORITY||LSM Difference|4.549|STANDARD_ERROR_OF_MEAN|1.179||0.0001|TWO_SIDED|95.0|2.236|6.861|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.861|2.236|0.0001
73889566|NCT02952820|147312058|SUPERIORITY||LSM Difference|4.667|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|2.373|6.96|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.960|2.373|<.0001
73889567|NCT02952820|147312059|SUPERIORITY||Least square mean (LSM) Difference|-14.328|STANDARD_ERROR_OF_MEAN|3.614|<|0.0001|TWO_SIDED|95.0|-21.411|-7.245|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-7.245|-21.411|<.0001
73889568|NCT02952820|147312059|SUPERIORITY||LSM Difference|-16.72|STANDARD_ERROR_OF_MEAN|3.619|<|0.0001|TWO_SIDED|95.0|-23.813|-9.626|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-9.626|-23.813|<.0001
73889569|NCT02952820|147312059|SUPERIORITY||LSM Difference|-5.514|STANDARD_ERROR_OF_MEAN|4.109||0.1796|TWO_SIDED|95.0|-13.568|2.54|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||2.540|-13.568|0.1796
73889570|NCT02952820|147312059|SUPERIORITY||LSM Difference|-7.005|STANDARD_ERROR_OF_MEAN|4.129||0.0898|TWO_SIDED|95.0|-15.098|1.088|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||1.088|-15.098|0.0898
73889571|NCT02952820|147312059|SUPERIORITY||LSM Difference|-13.424|STANDARD_ERROR_OF_MEAN|4.486||0.0028|TWO_SIDED|95.0|-22.218|-4.631|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-4.631|-22.218|0.0028
73889572|NCT02952820|147312059|SUPERIORITY||LSM Difference|-10.079|STANDARD_ERROR_OF_MEAN|4.578||0.0277|TWO_SIDED|95.0|-19.053|-1.104|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-1.104|-19.053|0.0277
73889573|NCT02952820|147312059|SUPERIORITY||LSM Difference|-17.474|STANDARD_ERROR_OF_MEAN|5.014||0.0005|TWO_SIDED|95.0|-27.306|-7.643|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-7.643|-27.306|0.0005
73889574|NCT02952820|147312059|SUPERIORITY||LSM Difference|-12.671|STANDARD_ERROR_OF_MEAN|4.951||0.0105|TWO_SIDED|95.0|-22.378|-2.964|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-2.964|-22.378|0.0105
73889575|NCT02952820|147312060|SUPERIORITY||LSM Difference|22.034|STANDARD_ERROR_OF_MEAN|4.354|<|0.0001|TWO_SIDED|95.0|13.488|30.579|||Mixed Models Analysis|||First 7 Nights After the First Dose (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||30.579|13.488|<.0001
73889576|NCT02952820|147312060|SUPERIORITY||LSM Difference|31.796|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|23.258|40.334|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||40.334|23.258|<.0001
73889577|NCT02952820|147312060|SUPERIORITY||LSM Difference|11.76|STANDARD_ERROR_OF_MEAN|5.269||0.0259|TWO_SIDED|95.0|1.418|22.102|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||22.102|1.418|0.0259
73889578|NCT02952820|147312060|SUPERIORITY||LSM Difference|22.131|STANDARD_ERROR_OF_MEAN|5.286|<|0.0001|TWO_SIDED|95.0|11.757|32.505|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||32.505|11.757|<.0001
73889579|NCT02952820|147312060|SUPERIORITY||LSM Difference|17.374|STANDARD_ERROR_OF_MEAN|5.906||0.0034|TWO_SIDED|95.0|5.781|28.968|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||28.968|5.781|0.0034
73889580|NCT02952820|147312060|SUPERIORITY||LSM Difference|21.686|STANDARD_ERROR_OF_MEAN|5.946||0.0003|TWO_SIDED|95.0|10.014|33.359|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||33.359|10.014|0.0003
73889581|NCT02952820|147312060|SUPERIORITY||LSM Difference|18.555|STANDARD_ERROR_OF_MEAN|6.324||0.0034|TWO_SIDED|95.0|6.14|30.969|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be missing at random (MAR).||30.969|6.140|0.0034
73889582|NCT02952820|147312060|SUPERIORITY||LSM Difference|22.686|STANDARD_ERROR_OF_MEAN|6.392||0.0004|TWO_SIDED|95.0|10.137|35.234|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||35.234|10.137|0.0004
73889583|NCT02952820|147312061|SUPERIORITY||Difference of percentage|13.67||||0.0004|TWO_SIDED|95.0|6.24|21.1|||Cochran-Mantel-Haenszel|||Sleep onset responders: Statistical analysis 1||21.10|6.24|0.0004
73889584|NCT02952820|147312061|SUPERIORITY||Difference of percentage|12.53||||0.0009|TWO_SIDED|95.0|5.2|19.86|||Cochran-Mantel-Haenszel|||Sleep Onset Responders: Statistical analysis 2||19.86|5.20|0.0009
73889585|NCT02952820|147312061|SUPERIORITY||Difference of percentage|14.65||||0.0002|TWO_SIDED|95.0|6.97|22.33|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 3||22.33|6.97|0.0002
73889586|NCT02952820|147312061|SUPERIORITY||Difference of percentage|9.82||||0.011|TWO_SIDED|95.0|2.29|17.35|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 4||17.35|2.29|0.0110
73889587|NCT02952820|147312063|SUPERIORITY||LSM Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.287||0.0137|TWO_SIDED|95.0|-1.27|-0.15|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.15|-1.27|0.0137
73889588|NCT02952820|147312063|SUPERIORITY||LSM Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.289||0.0011|TWO_SIDED|95.0|-1.51|-0.38|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.38|-1.51|0.0011
73889589|NCT02952820|147312063|SUPERIORITY||LSM Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.302||0.0001|TWO_SIDED|95.0|-1.75|-0.57|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.57|-1.75|0.0001
73889590|NCT02952820|147312063|SUPERIORITY||LSM Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.305|<|0.0001|TWO_SIDED|95.0|-1.96|-0.76|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.76|-1.96|<.0001
73889591|NCT02952820|147312063|SUPERIORITY||LSM Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.302|<|0.0001|TWO_SIDED|95.0|-1.9|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.71|-1.90|<.0001
73889592|NCT02952820|147312063|SUPERIORITY||LSM Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.307|<|0.0001|TWO_SIDED|95.0|-1.92|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.71|-1.92|<.0001
73889593|NCT02952820|147312064|SUPERIORITY||LSM Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.905||0.067|TWO_SIDED|95.0|-3.44|0.12|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||0.12|-3.44|0.0670
73889594|NCT02952820|147312064|SUPERIORITY||LSM Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.913||0.0257|TWO_SIDED|95.0|-3.83|-0.25|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.25|-3.83|0.0257
73889595|NCT02952820|147312064|SUPERIORITY||LSM Difference|-2.18|STANDARD_ERROR_OF_MEAN|0.939||0.0206|TWO_SIDED|95.0|-4.02|-0.34|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.34|-4.02|0.0206
73889596|NCT02952820|147312064|SUPERIORITY||LSM Difference|-3.04|STANDARD_ERROR_OF_MEAN|0.95||0.0014|TWO_SIDED|95.0|-4.91|-1.18|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-1.18|-4.91|0.0014
73889597|NCT02952820|147312064|SUPERIORITY||LSM Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.112||0.0134|TWO_SIDED|95.0|-4.48|-0.52|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.52|-4.48|0.0134
73889598|NCT02952820|147312064|SUPERIORITY||LSM Difference|-2.56|STANDARD_ERROR_OF_MEAN|1.026||0.0128|TWO_SIDED|95.0|-4.57|-0.54|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.54|-4.57|0.0128
73889599|NCT02952820|147312065|SUPERIORITY||LSM Difference|0.205|STANDARD_ERROR_OF_MEAN|0.076||0.0067|TWO_SIDED|95.0|0.057|0.353|||Mixed Models Analysis|||First 7 nights (Statistical analysis): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.353|0.057|0.0067
73889600|NCT02952820|147312065|SUPERIORITY||LSM Difference|0.171|STANDARD_ERROR_OF_MEAN|0.076||0.0237|TWO_SIDED|95.0|0.023|0.32|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.320|0.023|0.0237
73889601|NCT02952820|147312065|SUPERIORITY||LSM Difference|0.077|STANDARD_ERROR_OF_MEAN|0.094||0.412|TWO_SIDED|95.0|-0.107|0.261|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.261|-0.107|0.4120
73889602|NCT02952820|147312065|SUPERIORITY||LSM Difference|0.073|STANDARD_ERROR_OF_MEAN|0.094||0.4347|TWO_SIDED|95.0|-0.111|0.258|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.258|-0.111|0.4347
73889603|NCT02952820|147312065|SUPERIORITY||LSM Difference|0.074|STANDARD_ERROR_OF_MEAN|0.109||0.4992|TWO_SIDED|95.0|-0.141|0.289|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.289|-0.141|0.4992
73889604|NCT02952820|147312065|SUPERIORITY||LSM Difference|0.255|STANDARD_ERROR_OF_MEAN|0.11||0.0208|TWO_SIDED|95.0|0.039|0.471|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.471|0.039|0.0208
73889605|NCT02952820|147312065|SUPERIORITY||LSM Difference|0.144|STANDARD_ERROR_OF_MEAN|0.119||0.2248|TWO_SIDED|95.0|-0.089|0.378|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.378|-0.089|0.2248
73889606|NCT02952820|147312065|SUPERIORITY||LSM Difference|0.261|STANDARD_ERROR_OF_MEAN|0.12||0.0298|TWO_SIDED|95.0|0.026|0.497|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.497|0.026|0.0298
73889607|NCT03486834|147312085|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% confidence interval (CI).|Incidence Rate Estimate|2.9|||||TWO_SIDED|95.0|1.6|4.9||||||||4.9|1.6|
73889608|NCT03486834|147312085|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|5.1|||||TWO_SIDED|95.0|3.3|7.6||||||||7.6|3.3|
73889609|NCT03486834|147312085|OTHER|The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.|Vaccine Efficacy|42.4|||||TWO_SIDED|95.0|-13.5|71.1||||||||71.1|-13.5|
73889610|NCT03486834|147312086|OTHER||Difference in Percent|59.8|||||TWO_SIDED|95.0|55.8|63.5||||||||63.5|55.8|
73889611|NCT03486834|147312086|OTHER||Difference in Percent|57.6|||||TWO_SIDED|95.0|53.5|61.5||||||||61.5|53.5|
73889612|NCT03486834|147312087|OTHER||Difference in Percent|15.9|||||TWO_SIDED|95.0|11.7|20.1||||||||20.1|11.7|
73889613|NCT03486834|147312087|OTHER||Difference in Percent|17.4|||||TWO_SIDED|95.0|13.3|21.6||||||||21.6|13.3|
73889614|NCT03486834|147312088|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||||0.5|-0.5|
73889615|NCT03486834|147312088|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||||0.5|-0.5|
73889616|NCT03486834|147312089|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|6.7|||||TWO_SIDED|95.0|4.6|9.5||||||||9.5|4.6|
73889617|NCT03486834|147312089|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|5.1|||||TWO_SIDED|95.0|3.3|7.6||||||||7.6|3.3|
73889618|NCT03486834|147312089|OTHER|The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.|Vaccine Efficacy|-32.0|||||TWO_SIDED|95.0|-135.0|25.0||||||||25.0|-135.0|
73889619|NCT00638014|147312114|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||||||0.41
73889620|NCT03070964|147312122|SUPERIORITY||Exact binomial estimator|16.7|||||TWO_SIDED|95.0|2.1|48.4||||||||48.4|2.1|
73889621|NCT01094119|147312124|SUPERIORITY|||||||0.0069|||||||Regression, Logistic|||||||0.0069
73889622|NCT01587924|147312133|SUPERIORITY_OR_OTHER|||||||0.0135||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline Hgb \<10.80 versus modeled Hgb change from baseline in participants with Baseline Hgb \>= 10.80||||0.0135
73889623|NCT01587924|147312133|SUPERIORITY_OR_OTHER|||||||0.5082||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline weight \<= 80.5 Kg versus modeled Hgb change from baseline in participants with Baseline weight \> 80.5||||0.5082
73889624|NCT01587924|147312133|SUPERIORITY_OR_OTHER|||||||0.977||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino versus modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino||||0.9770
73889625|NCT01587924|147312133|SUPERIORITY_OR_OTHER|||||||0.0618||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline geographic ancestry as African American versus modeled Hgb change from baseline in participants with no geographic ancestry as African American||||0.0618
73889626|NCT01587924|147312133|SUPERIORITY_OR_OTHER|||||||0.7495||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline gender as male versus modeled Hgb change from baseline in participants with Baseline gender female||||0.7495
73889627|NCT01587924|147312133|SUPERIORITY_OR_OTHER|||||||0.7865||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline age \<65 years versus modeled Hgb change from baseline in participants with Baseline age \>=65 years||||0.7865
73889628|NCT01587924|147312133|SUPERIORITY_OR_OTHER|||||||0.0622||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline co-ad with food versus modeled Hgb change from baseline in participants with Baseline co-ad without food||||0.0622
73889629|NCT01587924|147312133|SUPERIORITY_OR_OTHER|||||||0.2044||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline diabetes presence versus modeled Hgb change from baseline in participants with no Baseline diabetes||||0.2044
73889630|NCT01587924|147312133|SUPERIORITY_OR_OTHER|||||||0.8537||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline region as the US and Canada versus modeled Hgb change from baseline in participants with Baseline region as not the US and Canada||||0.8537
73889631|NCT02379091|147312187|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.351||0.086|TWO_SIDED|95.0|-1.31|0.09||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and participant as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||0.09|-1.31|0.086
73889632|NCT02379091|147312187|SUPERIORITY_OR_OTHER||LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.366||0.107|TWO_SIDED|95.0|-1.32|0.13||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||0.13|-1.32|0.107
73889633|NCT02379091|147312187|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.347||0.01|TWO_SIDED|95.0|-1.61|-0.23||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||-0.23|-1.61|0.010
73889634|NCT00865566|147312247|OTHER|Score test|Hazard Ratio (HR)|0.73|||<|0.001|TWO_SIDED|95.0|0.63|0.84|||Regression, Cox||HR is vaccine / placebo|Cox proportional hazards model to assess the association between treatment assignment and dropout||0.84|0.63|<0.001
73889635|NCT00865566|147312248|OTHER||Hazard Ratio (HR)|0.77||||0.05|TWO_SIDED|95.0|0.59|1.0||Score test|Regression, Cox||HR is vaccine / placebo|Cox PH model to assess the association between treatment assignment and dropout||1|0.59|0.05
73889636|NCT00865566|147312249|OTHER||Cox Proportional Hazard|0.71|||<|0.001|TWO_SIDED|95.0|0.6|0.84||Score test|Regression, Cox||HR is vaccine / placebo|Assess the association between treatment assignment and dropout||0.84|0.60|<0.001
73889637|NCT00865566|147312250|OTHER||Hazard Ratio (HR)|1.02||||0.903|TWO_SIDED|95.0|0.73|1.42||Score test|Regression, Cox|Adjusted for age, behavioral risk score, square of behavioral risk score, race, and BMI|HR is vaccine / placebo|||1.42|0.73|0.903
73889638|NCT00865566|147312251|OTHER||Hazard Ratio (HR)|1.06||||0.783|TWO_SIDED|95.0|0.71|1.58||Adjusted for ave, behavioral risk score, square of behavioral risk score, and BMI|Regression, Cox|Score test|HR is vaccine / placebo|||1.58|0.71|0.783
73889639|NCT03847896|147312295|SUPERIORITY||Mean Difference (Final Values)|60.5||||0.025|TWO_SIDED|95.0|7.7|113.4|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||113.4|7.7|0.025
73889640|NCT03847896|147312295|SUPERIORITY||Mean Difference (Final Values)|161.9|||<|0.001|TWO_SIDED|95.0|109.4|214.5|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||214.5|109.4|<0.001
73889641|NCT03847896|147312295|SUPERIORITY||Mean Difference (Final Values)|80.7||||0.003|TWO_SIDED|95.0|28.4|132.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||132.9|28.4|0.003
73889642|NCT03847896|147312296|SUPERIORITY||Mean Difference (Final Values)|73.3||||0.037|TWO_SIDED|95.0|4.4|142.2|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||142.2|4.4|0.037
73889643|NCT03847896|147312296|SUPERIORITY||Mean Difference (Final Values)|99.9||||0.005|TWO_SIDED|95.0|30.9|168.8|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||168.8|30.9|0.005
73889644|NCT03847896|147312296|SUPERIORITY||Mean Difference (Final Values)|132.8|||<|0.001|TWO_SIDED|95.0|63.6|201.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||201.9|63.6|<0.001
73889645|NCT03847896|147312296|SUPERIORITY||Mean Difference (Final Values)|87.9||||0.013|TWO_SIDED|95.0|18.8|156.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||156.9|18.8|0.013
73889646|NCT03847896|147312296|SUPERIORITY||Mean Difference (Final Values)|120.8|||<|0.001|TWO_SIDED|95.0|51.5|190.1|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||190.1|51.5|<0.001
73889647|NCT03847896|147312297|SUPERIORITY||Median Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-6.0|1.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||1|-6|
73889648|NCT03847896|147312297|SUPERIORITY||Median Difference (Final Values)|3.0|||||TWO_SIDED|95.0|-3.0|9.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||9|-3|
73889649|NCT03847896|147312297|SUPERIORITY||Median Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-9.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-9|
73889650|NCT03847896|147312297|SUPERIORITY||Median Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-9.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-9|
73889651|NCT03847896|147312297|SUPERIORITY||Median Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-3|
73889652|NCT03847896|147312297|SUPERIORITY||Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-2.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-2|
73889653|NCT03847896|147312297|SUPERIORITY||Median Difference (Final Values)|-6.5|||||TWO_SIDED|95.0|-11.0|-2.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||-2|-11|
73889654|NCT03847896|147312297|SUPERIORITY||Median Difference (Final Values)|-6.5|||||TWO_SIDED|95.0|-11.0|-2.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||-2|-11|
73889655|NCT03847896|147312297|SUPERIORITY||Median Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||1|-1|
73889656|NCT03847896|147312299|SUPERIORITY||Odds Ratio (OR)|0.699||||0.118|TWO_SIDED|95.0|0.445|1.096|||Regression, Logistic|||Comparison is not type-I error controlled.||1.096|0.445|0.118
73889657|NCT03847896|147312299|SUPERIORITY||Odds Ratio (OR)|1.386||||0.161|TWO_SIDED|95.0|0.878|2.187|||Regression, Logistic|||Comparison is not type-I error controlled.||2.187|0.878|0.161
73889658|NCT03847896|147312299|SUPERIORITY||Odds Ratio (OR)|1.605||||0.044|TWO_SIDED|95.0|1.013|2.541|||Regression, Logistic|||Comparison is not type-I error controlled.||2.541|1.013|0.044
73889659|NCT03847896|147312299|SUPERIORITY||Odds Ratio (OR)|1.626||||0.039|TWO_SIDED|95.0|1.024|2.584|||Regression, Logistic|||Comparison is not type-I error controlled.||2.584|1.024|0.039
73889660|NCT03847896|147312299|SUPERIORITY||Odds Ratio (OR)|2.297|||<|0.001|TWO_SIDED|95.0|1.456|3.626|||Regression, Logistic|||Comparison is not type-I error controlled.||3.626|1.456|<0.001
73889661|NCT03847896|147312299|SUPERIORITY||Odds Ratio (OR)|2.328|||<|0.001|TWO_SIDED|95.0|1.471|3.687|||Regression, Logistic|||Comparison is not type-I error controlled.||3.687|1.471|<0.001
73889662|NCT03847896|147312299|SUPERIORITY||Odds Ratio (OR)|1.158||||0.532|TWO_SIDED|95.0|0.731|1.835|||Regression, Logistic|||Comparison is not type-I error controlled.||1.835|0.731|0.532
73889663|NCT03847896|147312299|SUPERIORITY||Odds Ratio (OR)|1.174||||0.499|TWO_SIDED|95.0|0.737|1.868|||Regression, Logistic|||Comparison is not type-I error controlled.||1.868|0.737|0.499
73889664|NCT03847896|147312299|SUPERIORITY||Odds Ratio (OR)|1.014||||0.955|TWO_SIDED|95.0|0.635|1.618|||Regression, Logistic|||Comparison is not type-I error controlled.||1.618|0.635|0.955
73889665|NCT03847896|147312300|SUPERIORITY||Mean Difference (Final Values)|-42.1||||0.169|TWO_SIDED|95.0|-101.9|17.8|||ANCOVA|||Comparison is not type-I error controlled.||17.8|-101.9|0.169
73889666|NCT03847896|147312300|SUPERIORITY||Mean Difference (Final Values)|52.1||||0.086|TWO_SIDED|95.0|-7.4|111.5|||ANCOVA|||Comparison is not type-I error controlled.||111.5|-7.4|0.086
73889667|NCT03847896|147312300|SUPERIORITY||Mean Difference (Final Values)|30.7||||0.31|TWO_SIDED|95.0|-28.6|90.1|||ANCOVA|||Comparison is not type-I error controlled.||90.1|-28.6|0.31
73889668|NCT03847896|147312300|SUPERIORITY||Mean Difference (Final Values)|65.9||||0.03|TWO_SIDED|95.0|6.3|125.4|||ANCOVA|||Comparison is not type-I error controlled.||125.4|6.3|0.03
73889669|NCT03847896|147312300|SUPERIORITY||Mean Difference (Final Values)|72.8||||0.017|TWO_SIDED|95.0|13.1|132.5|||ANCOVA|||Comparison is not type-I error controlled.||132.5|13.1|0.017
73889670|NCT03847896|147312300|SUPERIORITY||Mean Difference (Final Values)|107.9|||<|0.001|TWO_SIDED|95.0|48.1|167.8|||ANCOVA|||Comparison is not type-I error controlled.||167.8|48.1|<0.001
73889671|NCT03847896|147312300|SUPERIORITY||Mean Difference (Final Values)|-21.3||||0.48|TWO_SIDED|95.0|-80.5|37.9|||ANCOVA|||Comparison is not type-I error controlled.||37.9|-80.5|0.48
73889672|NCT03847896|147312300|SUPERIORITY||Mean Difference (Final Values)|13.8||||0.648|TWO_SIDED|95.0|-45.6|73.2|||ANCOVA|||Comparison is not type-I error controlled.||73.2|-45.6|0.648
73889673|NCT03847896|147312300|SUPERIORITY||Mean Difference (Final Values)|35.1||||0.246|TWO_SIDED|95.0|-24.2|94.5|||ANCOVA|||Comparison is not type-I error controlled.||94.5|-24.2|0.246
73889674|NCT02978781|147312309|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.227||0.9143|TWO_SIDED|95.0|-0.44|0.49|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14 (predose)|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.49|-0.44|0.9143
73889675|NCT02978781|147312310|OTHER||Least Squares Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.815||0.0529|TWO_SIDED|95.0|-3.5|0.03|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.03|-3.50|0.0529
73889676|NCT02978781|147312316|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|1.326||0.7795|TWO_SIDED|95.0|-3.47|2.7|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|2.70|-3.47|0.7795
73889677|NCT02978781|147312317|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.473||0.4846|TWO_SIDED|95.0|-0.65|1.33|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.33|-0.65|0.4846
73889678|NCT02978781|147312317|SUPERIORITY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.845||0.4567|TWO_SIDED|95.0|-2.7|1.36|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|"Change from Randomization in Lateral wing beating postural tremor (LWBPT) at Day 14"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.36|-2.70|0.4567
73889679|NCT02978781|147312318|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.85||0.3771|TWO_SIDED|95.0|-2.48|0.96|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.96|-2.48|0.3771
73889680|NCT02978781|147312319|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.415||0.7302|TWO_SIDED|95.0|-0.97|0.69|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.69|-0.97|0.7302
73889681|NCT02978781|147312319|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.467||0.7916|TWO_SIDED|95.0|-1.1|0.85|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|"Change from Randomization in Lateral wing beating postural tremor (LWBPT) at Day 14"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.85|-1.10|0.7916
73889682|NCT02978781|147312320|SUPERIORITY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.34||0.1807|TWO_SIDED|95.0|-1.17|0.23|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.23|-1.17|0.1807
73889683|NCT02978781|147312321|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.72||0.8709|TWO_SIDED|95.0|-1.7|1.9|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline(SAGE-217 - placebo)|Change from Baseline in Archimedes Spirals (AS) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.9|-1.7|0.8709
73889684|NCT02978781|147312321|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.7843|TWO_SIDED|95.0|-1.8|1.4|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217 - placebo)|Change from Baseline in Handwriting at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.4|-1.8|0.7843
73889685|NCT02978781|147312321|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.984||0.7604|TWO_SIDED|95.0|-2.72|2.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217 - placebo|Change from Baseline in Dot approximation task (DAT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|2.10|-2.72|0.7604
73889686|NCT02978781|147312322|OTHER||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.301||0.1333|TWO_SIDED|95.0|-1.13|0.17|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.17|-1.13|0.1333
73889687|NCT02978781|147312322|OTHER||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.389||0.0572|TWO_SIDED|95.0|-1.64|0.03|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|"Change from Baseline in Lateral wing beating postural tremor (LWBPT) at Day 15"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.03|-1.64|0.0572
73889688|NCT02978781|147312322|OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.255||0.0707|TWO_SIDED|95.0|-1.05|0.05|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Kinetic tremor (KT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.05|-1.05|0.0707
73889689|NCT02978781|147312323|OTHER||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.628||0.0278|TWO_SIDED|95.0|-2.87|-0.19|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.19|-2.87|0.0278
73889690|NCT02978781|147312324|OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.258||0.9579|TWO_SIDED|95.0|-0.57|0.54|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.54|-0.57|0.9579
73889691|NCT02978781|147312324|OTHER||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.234||0.0039|TWO_SIDED|95.0|-1.31|-0.3|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|"Change from Baseline in Lateral wing beating postural tremor (LWBPT) at Day 15"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.30|-1.31|0.0039
73889692|NCT02978781|147312324|OTHER||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.223||0.0099|TWO_SIDED|95.0|-1.14|-0.19|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Kinetic tremor (KT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.19|-1.14|0.0099
73889693|NCT02978781|147312325|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41||0.1595|TWO_SIDED|95.0|-1.5|0.3|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Archimedes spirals (AS) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.3|-1.5|0.1595
73889694|NCT02978781|147312325|OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0126|TWO_SIDED|95.0|-0.9|-0.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Handwriting at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.1|-0.9|0.0126
73889695|NCT02978781|147312325|OTHER||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.151||0.1536|TWO_SIDED|95.0|-0.55|0.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Dot approximation task (DAT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.10|-0.55|0.1536
73889696|NCT00785785|147312334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.466||||0.0081|TWO_SIDED|95.0|1.104|1.945|||Hazard Ratio|||||1.945|1.104|0.0081
73889697|NCT02453321|147312335|SUPERIORITY|||||||0.355|||||||Kruskal-Wallis|||||||0.355
73889698|NCT02453321|147312336|SUPERIORITY|||||||0.065|||||||Kruskal-Wallis|||||||0.065
73889699|NCT02282605|147312362|SUPERIORITY_OR_OTHER|||||||0.792|||||||Fisher Exact|||||||0.792
73889700|NCT02282605|147312362|SUPERIORITY_OR_OTHER|||||||0.887|||||||Fisher Exact|||||||0.887
73889701|NCT02282605|147312363|SUPERIORITY_OR_OTHER|||||||0.0058||||||For timepoint Day 3 (12 hours after last dose)|Fisher Exact|||||||0.0058
73889702|NCT02282605|147312365|SUPERIORITY_OR_OTHER|||||||0.028||||||The adjusted means were compared for the two-day treatment period.|ANCOVA|||||||0.028
73889703|NCT02282605|147312365|SUPERIORITY_OR_OTHER||||||<|0.001||||||The adjusted means were compared for the two-day treatment period to discharge.|ANCOVA|||||||<0.001
73889704|NCT02282605|147312365|SUPERIORITY_OR_OTHER|||||||0.005||||||The adjusted means were compared for the two-day treatment period through to discharge|ANCOVA|||||||0.005
73889705|NCT03584789|147312370|SUPERIORITY||Odds Ratio (OR)|1.29||||0.08|TWO_SIDED|97.5|0.93|1.8|||Mixed Models Analysis|||||1.80|.93|.08
73889706|NCT03584789|147312370|SUPERIORITY||Odds Ratio (OR)|1.24||||0.18|TWO_SIDED|97.5|0.86|1.79|||Mixed Models Analysis|||||1.79|.86|.18
73889707|NCT03584789|147312371|SUPERIORITY||Odds Ratio (OR)|1.37||||0.71|TWO_SIDED|97.5|0.2|9.44|||Mixed Models Analysis|||||9.44|.20|.71
73889708|NCT03584789|147312371|SUPERIORITY||Odds Ratio (OR)|1.53||||0.62|TWO_SIDED|97.5|0.21|11.0|||Mixed Models Analysis|||||11.00|.21|.62
73889709|NCT03584789|147312372|SUPERIORITY||Median Difference (Net)|-0.07||||0.38|TWO_SIDED|95.0|-0.26|0.12|||Mixed Models Analysis|||||.12|-0.26|.38
73889710|NCT03584789|147312372|SUPERIORITY||Median Difference (Net)|-0.03||||0.7|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|||||.17|-0.24|.70
73889711|NCT03584789|147312373|SUPERIORITY||Mean Difference (Net)|-0.14||||0.65|TWO_SIDED|95.0|-0.79|0.5|||Mixed Models Analysis|||||.50|-0.79|.65
73889712|NCT03584789|147312373|SUPERIORITY||Mean Difference (Net)|-0.29||||0.41|TWO_SIDED|95.0|-0.99|0.41|||Mixed Models Analysis|||||.41|-0.99|.41
73889713|NCT01532986|147312421|SUPERIORITY||Mean Difference (Final Values)|0.189|||>|0.05|TWO_SIDED|95.0|0.157|0.222|||t-test, 2 sided|||||0.222|0.157|>0.05
73889714|NCT01532986|147312422|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED|95.0|-0.04|0.08|||t-test, 2 sided|||||0.08|-0.04|>0.05
73889715|NCT01532986|147312423|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED|95.0|-0.52|0.57|||t-test, 2 sided|||||0.57|-0.52|>0.05
73889716|NCT01532986|147312424|SUPERIORITY||Mean Difference (Final Values)|-0.12|||>|0.05|TWO_SIDED|95.0|-0.34|0.1|||t-test, 2 sided|||||0.10|-0.34|>0.05
73889717|NCT01532986|147312425|SUPERIORITY||Mean Difference (Final Values)|-0.88|||>|0.05|TWO_SIDED|95.0|-2.04|0.29|||t-test, 2 sided|||||0.29|-2.04|>0.05
73889718|NCT01532986|147312426|SUPERIORITY||Mean Difference (Final Values)|1.22|||>|0.05|TWO_SIDED|95.0|-8.02|10.46|||t-test, 2 sided|||||10.46|-8.02|>0.05
73889719|NCT01532986|147312427|SUPERIORITY||Mean Difference (Final Values)|0.17|||>|0.05|TWO_SIDED|95.0|0.0|0.34|||t-test, 2 sided|||||0.34|0.00|>0.05
73889720|NCT01532986|147312428|SUPERIORITY||Mean Difference (Final Values)|-0.06|||>|0.05|TWO_SIDED|95.0|-1.45|1.33|||t-test, 2 sided|||||1.33|-1.45|>0.05
73889721|NCT01532986|147312429|SUPERIORITY||Mean Difference (Final Values)|-11.52|||<|0.05|TWO_SIDED|95.0|-20.42|-2.62|||t-test, 2 sided|||||-2.62|-20.42|<0.05
73889722|NCT01532986|147312430|SUPERIORITY||Mean Difference (Final Values)|-1.98|||>|0.05|TWO_SIDED|95.0|-4.2|0.24|||t-test, 2 sided|||||0.24|-4.20|>0.05
73889723|NCT00043979|147312442|SUPERIORITY_OR_OTHER|||||||0.0003||||||7 participants who did not receive a transplant compared with 21 participants transplanted.|Kaplan-Meier|||||||.0003
73889724|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA. Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
73889725|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|10.71|STANDARD_ERROR_OF_MEAN|6.26||0.0873|TWO_SIDED|60.0|5.44|15.98|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||15.98|5.44|0.0873
73889726|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|3.93|STANDARD_ERROR_OF_MEAN|5.71||0.4912|TWO_SIDED|60.0|-0.87|8.74|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||8.74|-0.87|0.4912
73889727|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|11.06|STANDARD_ERROR_OF_MEAN|6.61||0.0942|TWO_SIDED|60.0|5.5|16.62|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||16.62|5.50|0.0942
73889728|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|7.31|STANDARD_ERROR_OF_MEAN|6.36||0.2499|TWO_SIDED|60.0|1.96|12.66|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||12.66|1.96|0.2499
73889729|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|13.47|STANDARD_ERROR_OF_MEAN|7.1||0.058|TWO_SIDED|60.0|7.49|19.45|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||19.45|7.49|0.0580
73889730|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|12.62|STANDARD_ERROR_OF_MEAN|7.09||0.075|TWO_SIDED|60.0|6.66|18.59|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||18.59|6.66|0.0750
73889731|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|16.66|STANDARD_ERROR_OF_MEAN|7.75||0.0316|TWO_SIDED|60.0|10.14|23.19|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||23.19|10.14|0.0316
73889732|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|13.21|STANDARD_ERROR_OF_MEAN|7.5||0.0783|TWO_SIDED|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||19.53|6.90|0.0783
73889733|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|20.27|STANDARD_ERROR_OF_MEAN|9.14||0.0266|TWO_SIDED|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||27.96|12.58|0.0266
73889734|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|13.21|STANDARD_ERROR_OF_MEAN|7.5||0.0783|TWO_SIDED|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||19.53|6.90|0.0783
73889735|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|20.27|STANDARD_ERROR_OF_MEAN|9.14||0.0266|TWO_SIDED|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||27.96|12.58|0.0266
73889736|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|11.02|STANDARD_ERROR_OF_MEAN|7.74||0.1545|TWO_SIDED|60.0|4.51|17.54|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||17.54|4.51|0.1545
73889737|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|18.08|STANDARD_ERROR_OF_MEAN|9.34||0.0528|TWO_SIDED|60.0|10.22|25.94|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||25.94|10.22|0.0528
73889738|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|14.03|STANDARD_ERROR_OF_MEAN|8.45||0.0968|TWO_SIDED|60.0|6.92|21.14|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||21.14|6.92|0.0968
73889739|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||23.85|7.81|0.0966
73889740|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|17.07|STANDARD_ERROR_OF_MEAN|8.74||0.0507|TWO_SIDED|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||24.42|9.72|0.0507
73889741|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||23.85|7.81|0.0966
73889742|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|17.07|STANDARD_ERROR_OF_MEAN|8.74||0.0507|TWO_SIDED|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||24.42|9.72|0.0507
73889743|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||23.85|7.81|0.0966
73889744|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|18.17|STANDARD_ERROR_OF_MEAN|9.56||0.0574|TWO_SIDED|60.0|10.12|26.22|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||26.22|10.12|0.0574
73889745|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|21.08|STANDARD_ERROR_OF_MEAN|11.84||0.0749|TWO_SIDED|60.0|11.12|31.04|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||31.04|11.12|0.0749
73889746|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|3.65|STANDARD_ERROR_OF_MEAN|4.44||0.4116|TWO_SIDED|60.0|-0.09|7.38|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||7.38|-0.09|0.4116
73889747|NCT00658359|147312451|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.98|STANDARD_ERROR_OF_MEAN|3.69||0.7895|TWO_SIDED|60.0|-4.09|2.12|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.12|-4.09|0.7895
73889748|NCT00658359|147312452|SUPERIORITY_OR_OTHER||Estimated rate difference|2.4|STANDARD_ERROR_OF_MEAN|5.9||0.683|TWO_SIDED|95.0|-9.1|13.9|||Chi-squared||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|||13.9|-9.1|0.683
73889749|NCT00658359|147312452|SUPERIORITY_OR_OTHER||Estimated rate difference|3.9|STANDARD_ERROR_OF_MEAN|6.2||0.529|TWO_SIDED|95.0|-8.3|16.1|||Chi-squared||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|||16.1|-8.3|0.529
73889750|NCT00658359|147312453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.23|STANDARD_ERROR_OF_MEAN|5.04||0.0699|TWO_SIDED|60.0|4.97|13.49|||Mixed Models Analysis||Tofacitinib LI minus CsA|||13.49|4.97|0.0699
73889751|NCT00658359|147312453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.23|STANDARD_ERROR_OF_MEAN|6.32||0.1958|TWO_SIDED|60.0|2.89|13.58|||Mixed Models Analysis||Tofacitinib MI minus CsA|||13.58|2.89|0.1958
73889752|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
73889753|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.41|STANDARD_ERROR_OF_MEAN|4.89||0.934|TWO_SIDED|60.0|-4.52|3.71|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||3.71|-4.52|0.9340
73889754|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||5.08|-3.88|0.9106
73889755|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.30|-6.29|0.6960
73889756|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||5.08|-3.88|0.9106
73889757|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||2.30|-6.29|0.6960
73889758|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||5.08|-3.88|0.9106
73889759|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.30|-6.29|0.6960
73889760|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.18|STANDARD_ERROR_OF_MEAN|5.56||0.8322|TWO_SIDED|60.0|-5.86|3.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||3.50|-5.86|0.8322
73889761|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.77|STANDARD_ERROR_OF_MEAN|5.35||0.4809|TWO_SIDED|60.0|-8.27|0.73|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||0.73|-8.27|0.4809
73889762|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||1.62|-8.31|0.5704
73889763|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-1.14|-10.73|0.2972
73889764|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||1.62|-8.31|0.5704
73889765|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-1.14|-10.73|0.2972
73889766|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.62|-8.31|0.5704
73889767|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-1.14|-10.73|0.2972
73889768|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.62|-8.31|0.5704
73889769|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-1.14|-10.73|0.2972
73889770|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.62|-8.31|0.5704
73889771|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-1.14|-10.73|0.2972
73889772|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||1.62|-8.31|0.5704
73889773|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-1.14|-10.73|0.2972
73889774|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|3.75|STANDARD_ERROR_OF_MEAN|4.91||0.4455|TWO_SIDED|60.0|-0.39|7.89|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||7.89|-0.39|0.4455
73889775|NCT00658359|147312455|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.69|STANDARD_ERROR_OF_MEAN|4.34||0.873|TWO_SIDED|60.0|-4.35|2.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.96|-4.35|0.8730
73889776|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-10.52|STANDARD_ERROR_OF_MEAN|5.71||0.0654|TWO_SIDED|60.0|-15.33|-5.71|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-5.71|-15.33|0.0654
73889777|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.08|STANDARD_ERROR_OF_MEAN|6.37||0.3398|TWO_SIDED|60.0|-11.43|-0.72|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-0.72|-11.43|0.3398
73889778|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.75|STANDARD_ERROR_OF_MEAN|6.23||0.1601|TWO_SIDED|60.0|-13.99|-3.51|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-3.51|-13.99|0.1601
73889779|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.64|STANDARD_ERROR_OF_MEAN|6.49||0.239|TWO_SIDED|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-2.18|-13.10|0.2390
73889780|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.08|STANDARD_ERROR_OF_MEAN|6.4||0.2685|TWO_SIDED|60.0|-12.47|-1.7|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-1.70|-12.47|0.2685
73889781|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.64|STANDARD_ERROR_OF_MEAN|6.49||0.239|TWO_SIDED|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-2.18|-13.10|0.2390
73889782|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.81|STANDARD_ERROR_OF_MEAN|6.55||0.1785|TWO_SIDED|60.0|-14.32|-3.3|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-3.30|-14.32|0.1785
73889783|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-9.37|STANDARD_ERROR_OF_MEAN|6.63||0.158|TWO_SIDED|60.0|-14.95|-3.78|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-3.78|-14.95|0.1580
73889784|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.27|STANDARD_ERROR_OF_MEAN|6.81||0.0718|TWO_SIDED|60.0|-18.0|-6.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-6.53|-18.00|0.0718
73889785|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.83|STANDARD_ERROR_OF_MEAN|6.9||0.0629|TWO_SIDED|60.0|-18.63|-7.02|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-7.02|-18.63|0.0629
73889786|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate differences|-15.89|STANDARD_ERROR_OF_MEAN|7.07||0.0246|TWO_SIDED|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-9.94|-21.84|0.0246
73889787|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-16.45|STANDARD_ERROR_OF_MEAN|7.15||0.0214|TWO_SIDED|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-10.43|-22.46|0.0214
73889788|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-15.89|STANDARD_ERROR_OF_MEAN|7.07||0.0246|TWO_SIDED|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-9.94|-21.84|0.0246
73889789|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-16.45|STANDARD_ERROR_OF_MEAN|7.15||0.0214|TWO_SIDED|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-10.43|-22.46|0.0214
73889790|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-11.93|-24.12|0.0128
73889791|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-12.42|-24.74|0.0111
73889792|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-11.93|-24.12|0.0128
73889793|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-12.42|-24.74|0.0111
73889794|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-11.93|-24.12|0.0128
73889795|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-12.42|-24.74|0.0111
73889796|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-11.93|-24.12|0.0128
73889797|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-12.42|-24.74|0.0111
73889798|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.4|STANDARD_ERROR_OF_MEAN|5.41||0.1715|TWO_SIDED|60.0|-11.95|-2.84|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||-2.84|-11.95|0.1715
73889799|NCT00658359|147312456|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.8|STANDARD_ERROR_OF_MEAN|5.87||0.4131|TWO_SIDED|60.0|-9.74|0.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||0.14|-9.74|0.4131
73889800|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
73889801|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|1.45|STANDARD_ERROR_OF_MEAN|5.18||0.7799|TWO_SIDED|60.0|-2.91|5.8|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||5.80|-2.91|0.7799
73889802|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.99|STANDARD_ERROR_OF_MEAN|5.51||0.8572|TWO_SIDED|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||3.65|-5.63|0.8572
73889803|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.73|STANDARD_ERROR_OF_MEAN|5.56||0.7555|TWO_SIDED|60.0|-6.41|2.95|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.95|-6.41|0.7555
73889804|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.99|STANDARD_ERROR_OF_MEAN|5.51||0.8572|TWO_SIDED|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||3.65|-5.63|0.8572
73889805|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|3.82|STANDARD_ERROR_OF_MEAN|6.22||0.539|TWO_SIDED|60.0|-1.41|9.06|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||9.06|-1.41|0.5390
73889806|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.64|STANDARD_ERROR_OF_MEAN|5.7||0.6432|TWO_SIDED|60.0|-7.44|2.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.16|-7.44|0.6432
73889807|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|2.18|STANDARD_ERROR_OF_MEAN|6.39||0.7336|TWO_SIDED|60.0|-3.2|7.55|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||7.55|-3.20|0.7336
73889808|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.74|STANDARD_ERROR_OF_MEAN|6.57||0.9099|TWO_SIDED|60.0|-6.28|4.79|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||4.79|-6.28|0.9099
73889809|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|0.77|STANDARD_ERROR_OF_MEAN|6.87||0.9106|TWO_SIDED|60.0|-5.01|6.56|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||6.56|-5.01|0.9106
73889810|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|6.91||0.5244|TWO_SIDED|60.0|-10.22|1.42|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||1.42|-10.22|0.5244
73889811|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.9|STANDARD_ERROR_OF_MEAN|7.38||0.9029|TWO_SIDED|60.0|-7.11|5.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.31|-7.11|0.9029
73889812|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.58|STANDARD_ERROR_OF_MEAN|7.38||0.7267|TWO_SIDED|60.0|-8.78|3.63|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||3.63|-8.78|0.7267
73889813|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.73|STANDARD_ERROR_OF_MEAN|7.52||0.7168|TWO_SIDED|60.0|-9.06|3.6|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||3.60|-9.06|0.7168
73889814|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.91|-10.72|0.5574
73889815|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.56|STANDARD_ERROR_OF_MEAN|7.65||0.5515|TWO_SIDED|60.0|-10.99|1.88|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.88|-10.99|0.5515
73889816|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.91|-10.72|0.5574
73889817|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||4.33|-8.92|0.7704
73889818|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.91|-10.72|0.5574
73889819|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||4.33|-8.92|0.7704
73889820|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.44|STANDARD_ERROR_OF_MEAN|7.83||0.9551|TWO_SIDED|60.0|-7.03|6.15|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||6.15|-7.03|0.9551
73889821|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||4.33|-8.92|0.7704
73889822|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|4.91||0.4455|TWO_SIDED|60.0|-0.39|7.89|||Wald Test|||Month 12||7.89|-0.39|0.4455
73889823|NCT00658359|147312457|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.69|STANDARD_ERROR_OF_MEAN|4.34||0.873|TWO_SIDED|60.0|-4.35|2.96|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.96|-4.35|0.8730
73889824|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.98|STANDARD_ERROR_OF_MEAN|6.67||0.2957|TWO_SIDED|60.0|-12.6|-1.36|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-1.36|-12.60|0.2957
73889825|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.65|STANDARD_ERROR_OF_MEAN|7.14||0.6097|TWO_SIDED|60.0|-9.66|2.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||2.37|-9.66|0.6097
73889826|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|6.79||0.2064|TWO_SIDED|60.0|-14.28|-2.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-2.86|-14.28|0.2064
73889827|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.24|STANDARD_ERROR_OF_MEAN|7.25||0.4696|TWO_SIDED|60.0|-11.34|0.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||0.86|-11.34|0.4696
73889828|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|7.04||0.2238|TWO_SIDED|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-2.64|-14.50|0.2238
73889829|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.96|STANDARD_ERROR_OF_MEAN|7.52||0.5093|TWO_SIDED|60.0|-11.29|1.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||1.37|-11.29|0.5093
73889830|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|7.04||0.2238|TWO_SIDED|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-2.64|-14.50|0.2238
73889831|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.16|STANDARD_ERROR_OF_MEAN|7.89||0.7846|TWO_SIDED|60.0|-8.8|4.48|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||4.48|-8.80|0.7846
73889832|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-10.3|STANDARD_ERROR_OF_MEAN|7.16||0.1501|TWO_SIDED|60.0|-16.33|-4.28|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-4.28|-16.33|0.1501
73889833|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.89|STANDARD_ERROR_OF_MEAN|8.0||0.6263|TWO_SIDED|60.0|-10.62|2.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||2.84|-10.62|0.6263
73889834|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-6.25|-18.62|0.0905
73889835|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||0.84|-12.90|0.4604
73889836|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-6.25|-18.62|0.0905
73889837|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||0.84|-12.90|0.4604
73889838|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-6.25|-18.62|0.0905
73889839|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||0.84|-12.90|0.4604
73889840|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-6.25|-18.62|0.0905
73889841|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||0.84|-12.90|0.4604
73889842|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-6.25|-18.62|0.0905
73889843|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||0.84|-12.90|0.4604
73889844|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-6.25|-18.62|0.0905
73889845|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||0.84|-12.90|0.4604
73889846|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.29|STANDARD_ERROR_OF_MEAN|6.31||0.7166|TWO_SIDED|60.0|-7.61|3.02|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||3.02|-7.61|0.7166
73889847|NCT00658359|147312458|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.51|STANDARD_ERROR_OF_MEAN|6.24||0.4692|TWO_SIDED|60.0|-9.76|0.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||0.73|-9.76|0.4692
73889848|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|1.69|STANDARD_ERROR_OF_MEAN|1.68||0.3132|TWO_SIDED|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||3.11|0.28|0.3132
73889849|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|1.69|STANDARD_ERROR_OF_MEAN|1.68||0.3132|TWO_SIDED|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||3.11|0.28|0.3132
73889850|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||5.57|1.46|0.1503
73889851|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||5.57|1.46|0.1503
73889852|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.57|1.46|0.1503
73889853|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.57|1.46|0.1503
73889854|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.57|1.46|0.1503
73889855|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.57|1.46|0.1503
73889856|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||5.57|1.46|0.1503
73889857|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||5.57|1.46|0.1503
73889858|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||5.57|1.46|0.1503
73889859|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||5.57|1.46|0.1503
73889860|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||5.57|1.46|0.1503
73889861|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||5.57|1.46|0.1503
73889862|NCT00658359|147312459|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||5.57|1.46|0.1503
73889863|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.85|STANDARD_ERROR_OF_MEAN|1.83||0.3128|TWO_SIDED|60.0|-3.4|-0.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-0.31|-3.40|0.3128
73889864|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.91|0.26|0.3134
73889865|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.26|STANDARD_ERROR_OF_MEAN|2.42||0.9129|TWO_SIDED|60.0|-2.3|1.77|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||1.77|-2.30|0.9129
73889866|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||2.91|0.26|0.3134
73889867|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.19|STANDARD_ERROR_OF_MEAN|3.61||0.2447|TWO_SIDED|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-1.16|-7.23|0.2447
73889868|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.91|0.26|0.3134
73889869|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.19|STANDARD_ERROR_OF_MEAN|3.61||0.2447|TWO_SIDED|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-1.16|-7.23|0.2447
73889870|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||2.91|0.26|0.3134
73889871|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.44|STANDARD_ERROR_OF_MEAN|4.74||0.1164|TWO_SIDED|60.0|-11.43|-3.45|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-3.45|-11.43|0.1164
73889872|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|3.73|STANDARD_ERROR_OF_MEAN|2.62||0.1545|TWO_SIDED|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.93|1.52|0.1545
73889873|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.3|STANDARD_ERROR_OF_MEAN|5.18||0.3061|TWO_SIDED|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-0.94|-9.66|0.3061
73889874|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|3.73|STANDARD_ERROR_OF_MEAN|2.62||0.1545|TWO_SIDED|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.93|1.52|0.1545
73889875|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.3|STANDARD_ERROR_OF_MEAN|5.18||0.3061|TWO_SIDED|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-0.94|-9.66|0.3061
73889876|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||8.73|3.10|0.0774
73889877|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.59|-7.82|0.5772
73889878|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||8.73|3.10|0.0774
73889879|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.59|-7.82|0.5772
73889880|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||8.73|3.10|0.0774
73889881|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.59|-7.82|0.5772
73889882|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||8.73|3.10|0.0774
73889883|NCT00658359|147312460|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||1.59|-7.82|0.5772
73889884|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.35|STANDARD_ERROR_OF_MEAN|8.15||0.0786|TWO_SIDED|60.0|7.49|21.22|||Mixed Models Analysis|||Month 15||21.22|7.49|0.0786
73889885|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87|STANDARD_ERROR_OF_MEAN|8.5||0.736|TWO_SIDED|60.0|-10.03|4.29|||Mixed Models Analysis|||Month 15||4.29|-10.03|0.7360
73889886|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.16|STANDARD_ERROR_OF_MEAN|8.19||0.1377|TWO_SIDED|60.0|5.27|19.05|||Mixed Models Analysis|||Month 18||19.05|5.27|0.1377
73889887|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.01|STANDARD_ERROR_OF_MEAN|8.56||0.4131|TWO_SIDED|60.0|-14.21|0.2|||Mixed Models Analysis|||Month 18||0.20|-14.21|0.4131
73889888|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.52|STANDARD_ERROR_OF_MEAN|8.35||0.1057|TWO_SIDED|60.0|6.49|20.55|||Mixed Models Analysis|||Month 24||20.55|6.49|0.1057
73889889|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.21|STANDARD_ERROR_OF_MEAN|8.95||0.1402|TWO_SIDED|60.0|-20.75|-5.68|||Mixed Models Analysis|||Month 24||-5.68|-20.75|0.1402
73889890|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6|STANDARD_ERROR_OF_MEAN|9.13||0.0542|TWO_SIDED|60.0|9.91|25.29|||Mixed Models Analysis|||Month 30||25.29|9.91|0.0542
73889891|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.74|STANDARD_ERROR_OF_MEAN|10.09||0.3866|TWO_SIDED|60.0|0.24|17.24|||Mixed Models Analysis|||Month 30||17.24|0.24|0.3866
73889892|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.52|STANDARD_ERROR_OF_MEAN|9.72||0.1981|TWO_SIDED|60.0|4.33|20.71|||Mixed Models Analysis|||Month 36||20.71|4.33|0.1981
73889893|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.65|STANDARD_ERROR_OF_MEAN|12.07||0.6397|TWO_SIDED|60.0|-15.81|4.51|||Mixed Models Analysis|||Month 36||4.51|-15.81|0.6397
73889894|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.93|STANDARD_ERROR_OF_MEAN|10.19||0.0508|TWO_SIDED|60.0|11.35|28.51|||Mixed Models Analysis|||Month 42||28.51|11.35|0.0508
73889895|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.42|STANDARD_ERROR_OF_MEAN|12.9||0.5143|TWO_SIDED|60.0|-2.45|19.28|||Mixed Models Analysis|||Month 42||19.28|-2.45|0.5143
73889896|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.26|STANDARD_ERROR_OF_MEAN|10.45||0.0021|TWO_SIDED|60.0|23.46|41.06|||Mixed Models Analysis|||Month 48||41.06|23.46|0.0021
73889897|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.73|STANDARD_ERROR_OF_MEAN|13.47||0.5661|TWO_SIDED|60.0|-19.07|3.61|||Mixed Models Analysis|||Month 48||3.61|-19.07|0.5661
73889898|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.2|STANDARD_ERROR_OF_MEAN|10.54||0.0057|TWO_SIDED|60.0|20.33|38.08|||Mixed Models Analysis|||Month 54||38.08|20.33|0.0057
73889899|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.49|STANDARD_ERROR_OF_MEAN|13.89||0.4504|TWO_SIDED|60.0|-22.18|1.21|||Mixed Models Analysis|||Month 54||1.21|-22.18|0.4504
73889900|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.37|STANDARD_ERROR_OF_MEAN|11.39||0.0078|TWO_SIDED|60.0|20.78|39.96|||Mixed Models Analysis|||Month 60||39.96|20.78|0.0078
73889901|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.95|STANDARD_ERROR_OF_MEAN|14.44||0.6802|TWO_SIDED|60.0|-18.11|6.2|||Mixed Models Analysis|||Month 60||6.20|-18.11|0.6802
73889902|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|STANDARD_ERROR_OF_MEAN|12.08||0.0216|TWO_SIDED|60.0|17.61|37.95|||Mixed Models Analysis|||Month 66||37.95|17.61|0.0216
73889903|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|15.12||0.9026|TWO_SIDED|60.0|-14.58|10.88|||Mixed Models Analysis|||Month 66||10.88|-14.58|0.9026
73889904|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.38|STANDARD_ERROR_OF_MEAN|12.91||0.1146|TWO_SIDED|60.0|9.51|31.24|||Mixed Models Analysis|||Month 72||31.24|9.51|0.1146
73889905|NCT00658359|147312462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.14|STANDARD_ERROR_OF_MEAN|15.48||0.6918|TWO_SIDED|60.0|-19.18|6.9|||Mixed Models Analysis|||Month 72||6.90|-19.18|0.6918
73889906|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.62|STANDARD_ERROR_OF_MEAN|6.57||0.3139|TWO_SIDED|60.0|1.09|12.14|||Mixed Models Analysis|||Month 15||12.14|1.09|0.3139
73889907|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|6.75||0.5176|TWO_SIDED|60.0|-10.06|1.31|||Mixed Models Analysis|||Month 15||1.31|-10.06|0.5176
73889908|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.54|STANDARD_ERROR_OF_MEAN|6.56||0.3191|TWO_SIDED|60.0|1.02|12.06|||Mixed Models Analysis|||Month 18||12.06|1.02|0.3191
73889909|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|6.73||0.6608|TWO_SIDED|60.0|-8.62|2.71|||Mixed Models Analysis|||Month 18||2.71|-8.62|0.6608
73889910|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.02|STANDARD_ERROR_OF_MEAN|6.7||0.2319|TWO_SIDED|60.0|2.37|13.66|||Mixed Models Analysis|||Month 24||13.66|2.37|0.2319
73889911|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|7.04||0.3554|TWO_SIDED|60.0|-12.43|-0.58|||Mixed Models Analysis|||Month 24||-0.58|-12.43|0.3554
73889912|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.45|STANDARD_ERROR_OF_MEAN|7.27||0.0113|TWO_SIDED|60.0|12.33|24.57|||Mixed Models Analysis|||Month 30||24.57|12.33|0.0113
73889913|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66|STANDARD_ERROR_OF_MEAN|7.99||0.479|TWO_SIDED|60.0|-1.07|12.39|||Mixed Models Analysis|||Month 30||12.39|-1.07|0.4790
73889914|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.46|STANDARD_ERROR_OF_MEAN|7.75||0.1776|TWO_SIDED|60.0|3.93|16.99|||Mixed Models Analysis|||Month 36||16.99|3.93|0.1776
73889915|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27|STANDARD_ERROR_OF_MEAN|9.5||0.7307|TWO_SIDED|60.0|-11.27|4.73|||Mixed Models Analysis|||Month 36||4.73|-11.27|0.7307
73889916|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.53|STANDARD_ERROR_OF_MEAN|8.25||0.1625|TWO_SIDED|60.0|4.59|18.48|||Mixed Models Analysis|||Month 42||18.48|4.59|0.1625
73889917|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.77|STANDARD_ERROR_OF_MEAN|10.12||0.2876|TWO_SIDED|60.0|2.25|19.29|||Mixed Models Analysis|||Month 42||19.29|2.25|0.2876
73889918|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.62|STANDARD_ERROR_OF_MEAN|8.41||0.027|TWO_SIDED|60.0|11.54|25.7|||Mixed Models Analysis|||Month 48||25.70|11.54|0.0270
73889919|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|10.54||0.7444|TWO_SIDED|60.0|-12.31|5.44|||Mixed Models Analysis|||Month 48||5.44|-12.31|0.7444
73889920|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.18|STANDARD_ERROR_OF_MEAN|8.44||0.0122|TWO_SIDED|60.0|14.08|28.29|||Mixed Models Analysis|||Month 54||28.29|14.08|0.0122
73889921|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.61|STANDARD_ERROR_OF_MEAN|10.86||0.3288|TWO_SIDED|60.0|-19.75|-1.47|||Mixed Models Analysis|||Month 54||-1.47|-19.75|0.3288
73889922|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.34|STANDARD_ERROR_OF_MEAN|9.15||0.0453|TWO_SIDED|60.0|10.63|26.05|||Mixed Models Analysis|||Month 60||26.05|10.63|0.0453
73889923|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59|STANDARD_ERROR_OF_MEAN|11.28||0.5016|TWO_SIDED|60.0|-17.09|1.91|||Mixed Models Analysis|||Month 60||1.91|-17.09|0.5016
73889924|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.43|STANDARD_ERROR_OF_MEAN|9.69||0.0453|TWO_SIDED|60.0|11.27|27.59|||Mixed Models Analysis|||Month 66||27.59|11.27|0.0453
73889925|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87|STANDARD_ERROR_OF_MEAN|11.84||0.8747|TWO_SIDED|60.0|-11.83|8.1|||Mixed Models Analysis|||Month 66||8.10|-11.83|0.8747
73889926|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.98|STANDARD_ERROR_OF_MEAN|10.34||0.4997|TWO_SIDED|60.0|-1.72|15.69|||Mixed Models Analysis|||Month 72||15.69|-1.72|0.4997
73889927|NCT00658359|147312463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.07|STANDARD_ERROR_OF_MEAN|12.1||0.2804|TWO_SIDED|60.0|-23.26|-2.88|||Mixed Models Analysis|||Month 72||-2.88|-23.26|0.2804
73889928|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.79|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|60.0|7.68|11.9|||Mixed Models Analysis|||Month 15||11.90|7.68|<0.0001
73889929|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.32|STANDARD_ERROR_OF_MEAN|2.61||0.0418|TWO_SIDED|60.0|3.12|7.52|||Mixed Models Analysis|||Month 15||7.52|3.12|0.0418
73889930|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|STANDARD_ERROR_OF_MEAN|2.51||0.0002|TWO_SIDED|60.0|7.28|11.51|||Mixed Models Analysis|||Month 18||11.51|7.28|0.0002
73889931|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|2.63||0.0437|TWO_SIDED|60.0|3.09|7.51|||Mixed Models Analysis|||Month 18||7.51|3.09|0.0437
73889932|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.37|STANDARD_ERROR_OF_MEAN|2.56||0.0011|TWO_SIDED|60.0|6.21|10.53|||Mixed Models Analysis|||Month 24||10.53|6.21|0.0011
73889933|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|STANDARD_ERROR_OF_MEAN|2.75||0.4565|TWO_SIDED|60.0|-0.27|4.36|||Mixed Models Analysis|||Month 24||4.36|-0.27|0.4565
73889934|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.9|STANDARD_ERROR_OF_MEAN|2.8||0.0001|TWO_SIDED|60.0|8.54|13.26|||Mixed Models Analysis|||Month 30||13.26|8.54|0.0001
73889935|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.29|STANDARD_ERROR_OF_MEAN|3.09||0.1654|TWO_SIDED|60.0|1.69|6.89|||Mixed Models Analysis|||Month 30||6.89|1.69|0.1654
73889936|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45|STANDARD_ERROR_OF_MEAN|2.98||0.0015|TWO_SIDED|60.0|6.95|11.96|||Mixed Models Analysis|||Month 36||11.96|6.95|0.0015
73889937|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.13|STANDARD_ERROR_OF_MEAN|3.69||0.2636|TWO_SIDED|60.0|1.02|7.23|||Mixed Models Analysis|||Month 36||7.23|1.02|0.2636
73889938|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08|STANDARD_ERROR_OF_MEAN|3.12||0.052|TWO_SIDED|60.0|3.45|8.71|||Mixed Models Analysis|||Month 42||8.71|3.45|0.0520
73889939|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35|STANDARD_ERROR_OF_MEAN|3.95||0.176|TWO_SIDED|60.0|2.02|8.67|||Mixed Models Analysis|||Month 42||8.67|2.02|0.1760
73889940|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.08|STANDARD_ERROR_OF_MEAN|3.2||0.0274|TWO_SIDED|60.0|4.38|9.77|||Mixed Models Analysis|||Month 48||9.77|4.38|0.0274
73889941|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|4.13||0.8018|TWO_SIDED|60.0|-4.51|2.44|||Mixed Models Analysis|||Month 48||2.44|-4.51|0.8018
73889942|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.63|STANDARD_ERROR_OF_MEAN|3.23||0.0819|TWO_SIDED|60.0|2.91|8.35|||Mixed Models Analysis|||Month 54||8.35|2.91|0.0819
73889943|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|4.26||0.6103|TWO_SIDED|60.0|-5.75|1.41|||Mixed Models Analysis|||Month 54||1.41|-5.75|0.6103
73889944|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|3.49||0.1168|TWO_SIDED|60.0|2.54|8.41|||Mixed Models Analysis|||Month 60||8.41|2.54|0.1168
73889945|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|4.43||0.3357|TWO_SIDED|60.0|0.54|7.99|||Mixed Models Analysis|||Month 60||7.99|0.54|0.3357
73889946|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.42|STANDARD_ERROR_OF_MEAN|3.7||0.0448|TWO_SIDED|60.0|4.31|10.54|||Mixed Models Analysis|||Month 66||10.54|4.31|0.0448
73889947|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|4.64||0.7642|TWO_SIDED|60.0|-2.51|5.29|||Mixed Models Analysis|||Month 66||5.29|-2.51|0.7642
73889948|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|STANDARD_ERROR_OF_MEAN|3.95||0.1295|TWO_SIDED|60.0|2.67|9.32|||Mixed Models Analysis|||Month 72||9.32|2.67|0.1295
73889949|NCT00658359|147312464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|STANDARD_ERROR_OF_MEAN|4.75||0.654|TWO_SIDED|60.0|-1.87|6.13|||Mixed Models Analysis|||Month 72||6.13|-1.87|0.6540
73889950|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.11|STANDARD_ERROR_OF_MEAN|19.53||0.7543|TWO_SIDED|60.0|-22.55|10.33|||Mixed Models Analysis|||Month 15||10.33|-22.55|0.7543
73889951|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.95|STANDARD_ERROR_OF_MEAN|20.33||0.6249|TWO_SIDED|60.0|-27.07|7.17|||Mixed Models Analysis|||Month 15||7.17|-27.07|0.6249
73889952|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.66|STANDARD_ERROR_OF_MEAN|19.61||0.3415|TWO_SIDED|60.0|-35.17|-2.15|||Mixed Models Analysis|||Month 18||-2.15|-35.17|0.3415
73889953|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.86|STANDARD_ERROR_OF_MEAN|20.47||0.072|TWO_SIDED|60.0|-54.1|-19.63|||Mixed Models Analysis|||Month 18||-19.63|-54.10|0.0720
73889954|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|19.99||0.2937|TWO_SIDED|60.0|-37.83|-4.17|||Mixed Models Analysis|||Month 24||-4.17|-37.83|0.2937
73889955|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.72|STANDARD_ERROR_OF_MEAN|21.38||0.0512|TWO_SIDED|60.0|-59.72|-23.73|||Mixed Models Analysis|||Month 24||-23.73|-59.72|0.0512
73889956|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.43|STANDARD_ERROR_OF_MEAN|21.76||0.037|TWO_SIDED|60.0|-63.75|-27.11|||Mixed Models Analysis|||Month 30||-27.11|-63.75|0.0370
73889957|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|24.0||0.8701|TWO_SIDED|60.0|-24.13|16.28|||Mixed Models Analysis|||Month 30||16.28|-24.13|0.8701
73889958|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.75|STANDARD_ERROR_OF_MEAN|23.15||0.2146|TWO_SIDED|60.0|-48.24|-9.25|||Mixed Models Analysis|||Month 36||-9.25|-48.24|0.2146
73889959|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.03|STANDARD_ERROR_OF_MEAN|28.58||0.462|TWO_SIDED|60.0|-45.09|3.03|||Mixed Models Analysis|||Month 36||3.03|-45.09|0.4620
73889960|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.16|STANDARD_ERROR_OF_MEAN|24.28||0.8639|TWO_SIDED|60.0|-16.28|24.6|||Mixed Models Analysis|||Month 42||24.60|-16.28|0.8639
73889961|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.3|STANDARD_ERROR_OF_MEAN|30.65||0.323|TWO_SIDED|60.0|-56.11|-4.5|||Mixed Models Analysis|||Month 42||-4.50|-56.11|0.3230
73889962|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.49|STANDARD_ERROR_OF_MEAN|24.92||0.2214|TWO_SIDED|60.0|9.51|51.47|||Mixed Models Analysis|||Month 48||51.47|9.51|0.2214
73889963|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.25|STANDARD_ERROR_OF_MEAN|32.08||0.7492|TWO_SIDED|60.0|-37.26|16.75|||Mixed Models Analysis|||Month 48||16.75|-37.26|0.7492
73889964|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|25.15||0.8236|TWO_SIDED|60.0|-15.57|26.79|||Mixed Models Analysis|||Month 54||26.79|-15.57|0.8236
73889965|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.67|STANDARD_ERROR_OF_MEAN|33.1||0.6578|TWO_SIDED|60.0|-13.2|42.54|||Mixed Models Analysis|||Month 54||42.54|-13.20|0.6578
73889966|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.93|STANDARD_ERROR_OF_MEAN|27.12||0.5326|TWO_SIDED|60.0|-5.9|39.76|||Mixed Models Analysis|||Month 60||39.76|-5.90|0.5326
73889967|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|34.44||0.6845|TWO_SIDED|60.0|-42.99|15.0|||Mixed Models Analysis|||Month 60||15.00|-42.99|0.6845
73889968|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.35|STANDARD_ERROR_OF_MEAN|28.73||0.7713|TWO_SIDED|60.0|-15.83|32.54|||Mixed Models Analysis|||Month 66||32.54|-15.83|0.7713
73889969|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.11|STANDARD_ERROR_OF_MEAN|36.06||0.8438|TWO_SIDED|60.0|-37.47|23.26|||Mixed Models Analysis|||Month 66||23.26|-37.47|0.8438
73889970|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.06|STANDARD_ERROR_OF_MEAN|30.7||0.4724|TWO_SIDED|60.0|-3.78|47.91|||Mixed Models Analysis|||Month 72||47.91|-3.78|0.4724
73889971|NCT00658359|147312465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.25|STANDARD_ERROR_OF_MEAN|36.98||0.6218|TWO_SIDED|60.0|-12.89|49.38|||Mixed Models Analysis|||Month 72||49.38|-12.89|0.6218
73889972|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|7.93||0.7693|TWO_SIDED|60.0|-9.01|4.35|||Mixed Models Analysis|||Month 15||4.35|-9.01|0.7693
73889973|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.75|STANDARD_ERROR_OF_MEAN|8.28||0.7396|TWO_SIDED|60.0|-4.22|9.73|||Mixed Models Analysis|||Month 15||9.73|-4.22|0.7396
73889974|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|STANDARD_ERROR_OF_MEAN|7.92||0.3881|TWO_SIDED|60.0|-13.51|-0.17|||Mixed Models Analysis|||Month 18||-0.17|-13.51|0.3881
73889975|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|STANDARD_ERROR_OF_MEAN|8.28||0.5114|TWO_SIDED|60.0|-12.42|1.53|||Mixed Models Analysis|||Month 18||1.53|-12.42|0.5114
73889976|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.43|STANDARD_ERROR_OF_MEAN|8.06||0.5829|TWO_SIDED|60.0|-11.21|2.36|||Mixed Models Analysis|||Month 24||2.36|-11.21|0.5829
73889977|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.76|STANDARD_ERROR_OF_MEAN|8.58||0.2559|TWO_SIDED|60.0|-16.99|-2.53|||Mixed Models Analysis|||Month 24||-2.53|-16.99|0.2559
73889978|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|8.78||0.7548|TWO_SIDED|60.0|-4.65|10.14|||Mixed Models Analysis|||Month 30||10.14|-4.65|0.7548
73889979|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|9.57||0.7998|TWO_SIDED|60.0|-5.63|10.49|||Mixed Models Analysis|||Match 30||10.49|-5.63|0.7998
73889980|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.39|STANDARD_ERROR_OF_MEAN|9.08||0.2531|TWO_SIDED|60.0|2.74|18.03|||Mixed Models Analysis|||Month 36||18.03|2.74|0.2531
73889981|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.14|STANDARD_ERROR_OF_MEAN|11.2||0.365|TWO_SIDED|60.0|0.72|19.57|||Mixed Models Analysis|||Month 36||19.57|0.72|0.3650
73889982|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.33|STANDARD_ERROR_OF_MEAN|9.34||0.4328|TWO_SIDED|60.0|-0.53|15.19|||Mixed Models Analysis|||Month 42||15.19|-0.53|0.4328
73889983|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.94|STANDARD_ERROR_OF_MEAN|11.35||0.2547|TWO_SIDED|60.0|-22.5|-3.38|||Mixed Models Analysis|||Month 42||-3.38|-22.50|0.2547
73889984|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.72|STANDARD_ERROR_OF_MEAN|9.46||0.3572|TWO_SIDED|60.0|0.75|16.69|||Mixed Models Analysis|||Month 48||16.69|0.75|0.3572
73889985|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94|STANDARD_ERROR_OF_MEAN|11.64||0.8009|TWO_SIDED|60.0|-6.86|12.74|||Mixed Models Analysis|||Month 48||12.74|-6.86|0.8009
73889986|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|9.44||0.6814|TWO_SIDED|60.0|-11.82|4.07|||Mixed Models Analysis|||Month 54||4.07|-11.82|0.6814
73889987|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.88|STANDARD_ERROR_OF_MEAN|11.93||0.2803|TWO_SIDED|60.0|2.84|22.93|||Mixed Models Analysis|||Month 54||22.93|2.84|0.2803
73889988|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.11|STANDARD_ERROR_OF_MEAN|10.23||0.7613|TWO_SIDED|60.0|-11.72|5.5|||Mixed Models Analysis|||Month 60||5.50|-11.72|0.7613
73889989|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|12.35||0.8554|TWO_SIDED|60.0|-12.65|8.15|||Mixed Models Analysis|||Month 60||8.15|-12.65|0.8554
73889990|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|10.7||0.9132|TWO_SIDED|60.0|-10.18|7.84|||Mixed Models Analysis|||Month 66||7.84|-10.18|0.9132
73889991|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.14|STANDARD_ERROR_OF_MEAN|12.79||0.7465|TWO_SIDED|60.0|-6.63|14.9|||Mixed Models Analysis|||Month 66||14.90|-6.63|0.7465
73889992|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|11.34||0.8747|TWO_SIDED|60.0|-11.34|7.76|||Mixed Models Analysis|||Month 72||7.76|-11.34|0.8747
73889993|NCT00658359|147312469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.19|STANDARD_ERROR_OF_MEAN|12.96||0.5793|TWO_SIDED|60.0|-18.1|3.72|||Mixed Models Analysis|||Month 72||3.72|-18.10|0.5793
73889994|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.76|STANDARD_ERROR_OF_MEAN|2.79|<|0.0001|TWO_SIDED|60.0|10.4|15.11|||Mixed Models Analysis|||Month 15||15.11|10.40|<0.0001
73889995|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.39|STANDARD_ERROR_OF_MEAN|2.88|<|0.0001|TWO_SIDED|60.0|10.96|15.82|||Mixed Models Analysis|||Month 15||15.82|10.96|<0.0001
73889996|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.48|STANDARD_ERROR_OF_MEAN|3.0||0.0002|TWO_SIDED|60.0|8.95|14.0|||Mixed Models Analysis|||Month 18||14.00|8.95|0.0002
73889997|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.98|STANDARD_ERROR_OF_MEAN|3.09||0.0002|TWO_SIDED|60.0|9.37|14.59|||Mixed Models Analysis|||Month 18||14.59|9.37|0.0002
73889998|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.86|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|60.0|10.32|15.39|||Mixed Models Analysis|||Month 24||15.39|10.32|<0.0001
73889999|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.71|STANDARD_ERROR_OF_MEAN|3.12|<|0.0001|TWO_SIDED|60.0|11.08|16.35|||Mixed Models Analysis|||Month 24||16.35|11.08|<0.0001
73890000|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.86|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|60.0|13.03|18.69|||Mixed Models Analysis|||Month 30||18.69|13.03|<0.0001
73890001|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.61|STANDARD_ERROR_OF_MEAN|3.56||0.0002|TWO_SIDED|60.0|10.61|16.61|||Mixed Models Analysis|||Month 30||16.61|10.61|0.0002
73890002|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.17|STANDARD_ERROR_OF_MEAN|3.61||0.001|TWO_SIDED|60.0|9.12|15.21|||Mixed Models Analysis|||Month 36||15.21|9.12|0.0010
73890003|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.56|STANDARD_ERROR_OF_MEAN|3.98||0.0019|TWO_SIDED|60.0|9.2|15.92|||Mixed Models Analysis|||Month 36||15.92|9.20|0.0019
73890004|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.42|STANDARD_ERROR_OF_MEAN|3.38||0.0004|TWO_SIDED|60.0|9.56|15.27|||Mixed Models Analysis|||Month 42||15.27|9.56|0.0004
73890005|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_ERROR_OF_MEAN|3.76||0.0182|TWO_SIDED|60.0|5.81|12.16|||Mixed Models Analysis|||Month 42||12.16|5.81|0.0182
73890006|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.4|STANDARD_ERROR_OF_MEAN|3.77||0.0013|TWO_SIDED|60.0|9.22|15.58|||Mixed Models Analysis|||Month 48||15.58|9.22|0.0013
73890007|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|4.29||0.0782|TWO_SIDED|60.0|3.99|11.22|||Mixed Models Analysis|||Month 48||11.22|3.99|0.0782
73890008|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.04|STANDARD_ERROR_OF_MEAN|4.02||0.0007|TWO_SIDED|60.0|10.64|17.43|||Mixed Models Analysis|||Month 54||17.43|10.64|0.0007
73890009|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.23|STANDARD_ERROR_OF_MEAN|4.72||0.0322|TWO_SIDED|60.0|6.24|14.22|||Mixed Models Analysis|||Month 54||14.22|6.24|0.0322
73890010|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.72|STANDARD_ERROR_OF_MEAN|3.7||0.0399|TWO_SIDED|60.0|4.59|10.86|||Mixed Models Analysis|||Month 60||10.86|4.59|0.0399
73890011|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.11|STANDARD_ERROR_OF_MEAN|4.28||0.3391|TWO_SIDED|60.0|0.49|7.73|||Mixed Models Analysis|||Month 60||7.73|0.49|0.3391
73890012|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.75|STANDARD_ERROR_OF_MEAN|4.23||0.0702|TWO_SIDED|60.0|4.17|11.33|||Mixed Models Analysis|||Month 66||11.33|4.17|0.0702
73890013|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.02|STANDARD_ERROR_OF_MEAN|4.89||0.221|TWO_SIDED|60.0|1.89|10.15|||Mixed Models Analysis|||Month 66||10.15|1.89|0.2210
73890014|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.03|STANDARD_ERROR_OF_MEAN|5.25||0.015|TWO_SIDED|60.0|8.59|17.46|||Mixed Models Analysis|||Month 72||17.46|8.59|0.0150
73890015|NCT00658359|147312471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.27|STANDARD_ERROR_OF_MEAN|6.13||0.4875|TWO_SIDED|60.0|-0.91|9.45|||Mixed Models Analysis|||Month 72||9.45|-0.91|0.4875
73890016|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.48|STANDARD_ERROR_OF_MEAN|4.33||0.001|TWO_SIDED|60.0|10.83|18.13|||Mixed Models Analysis|||Month 15||18.13|10.83|0.0010
73890017|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|4.47||0.001|TWO_SIDED|60.0|11.16|18.7|||Mixed Models Analysis|||Month 15||18.70|11.16|0.0010
73890018|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.96|STANDARD_ERROR_OF_MEAN|4.5||0.0023|TWO_SIDED|60.0|10.16|17.76|||Mixed Models Analysis|||Month 18||17.76|10.16|0.0023
73890019|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.57|STANDARD_ERROR_OF_MEAN|4.64||0.0039|TWO_SIDED|60.0|9.65|17.48|||Mixed Models Analysis|||Month 18||17.48|9.65|0.0039
73890020|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.02|STANDARD_ERROR_OF_MEAN|4.72||0.0017|TWO_SIDED|60.0|11.04|19.0|||Mixed Models Analysis|||Month 24||19.00|11.04|0.0017
73890021|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|4.88||0.0026|TWO_SIDED|60.0|10.81|19.04|||Mixed Models Analysis|||Month 24||19.04|10.81|0.0026
73890022|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.54|STANDARD_ERROR_OF_MEAN|5.06||0.0003|TWO_SIDED|60.0|14.27|22.81|||Mixed Models Analysis|||Month 30||22.81|14.27|0.0003
73890023|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.45|STANDARD_ERROR_OF_MEAN|5.29||0.0022|TWO_SIDED|60.0|11.99|20.91|||Mixed Models Analysis|||Month 30||20.91|11.99|0.0022
73890024|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.19|STANDARD_ERROR_OF_MEAN|5.51||0.0065|TWO_SIDED|60.0|10.55|19.84|||Mixed Models Analysis|||Month 36||19.84|10.55|0.0065
73890025|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|6.0||0.0137|TWO_SIDED|60.0|9.87|19.99|||Mixed Models Analysis|||Month 36||19.99|9.87|0.0137
73890026|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.32|STANDARD_ERROR_OF_MEAN|5.12||0.0018|TWO_SIDED|60.0|11.99|20.64|||Mixed Models Analysis|||Month 42||20.64|11.99|0.0018
73890027|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.24|STANDARD_ERROR_OF_MEAN|5.65||0.0316|TWO_SIDED|60.0|7.47|17.01|||Mixed Models Analysis|||Month 42||17.01|7.47|0.0316
73890028|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.33|STANDARD_ERROR_OF_MEAN|5.64||0.0043|TWO_SIDED|60.0|11.57|21.09|||Mixed Models Analysis|||Month 48||21.09|11.57|0.0043
73890029|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8|STANDARD_ERROR_OF_MEAN|6.31||0.1226|TWO_SIDED|60.0|4.47|15.12|||Mixed Models Analysis|||Month 48||15.12|4.47|0.1226
73890030|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.97|STANDARD_ERROR_OF_MEAN|5.7||0.0034|TWO_SIDED|60.0|12.17|21.78|||Mixed Models Analysis|||Month 54||21.78|12.17|0.0034
73890031|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.79|STANDARD_ERROR_OF_MEAN|6.52||0.0724|TWO_SIDED|60.0|6.29|17.29|||Mixed Models Analysis|||Month 54||17.29|6.29|0.0724
73890032|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.03|STANDARD_ERROR_OF_MEAN|5.92||0.1782|TWO_SIDED|60.0|3.02|13.03|||Mixed Models Analysis|||Month 60||13.03|3.02|0.1782
73890033|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|6.86||0.5947|TWO_SIDED|60.0|-2.14|9.46|||Mixed Models Analysis|||Month 66||9.46|-2.14|0.5947
73890034|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.99|STANDARD_ERROR_OF_MEAN|5.68||0.081|TWO_SIDED|60.0|5.2|14.79|||Mixed Models Analysis|||Month 66||14.79|5.20|0.0810
73890035|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42|STANDARD_ERROR_OF_MEAN|6.38||0.3965|TWO_SIDED|60.0|0.04|10.81|||Mixed Models Analysis|||Month 66||10.81|0.04|0.3965
73890036|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.16|STANDARD_ERROR_OF_MEAN|6.77||0.0128|TWO_SIDED|60.0|11.44|22.88|||Mixed Models Analysis|||Month 72||22.88|11.44|0.0128
73890037|NCT00658359|147312472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|7.83||0.5487|TWO_SIDED|60.0|-1.91|11.33|||Mixed Models Analysis|||Month 72||11.33|-1.91|0.5487
73890038|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.87|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|60.0|13.46|18.29|||Mixed Models Analysis|||Month 15||18.29|13.46|<0.0001
73890039|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.97|STANDARD_ERROR_OF_MEAN|2.95|<|0.0001|TWO_SIDED|60.0|11.49|16.46|||Mixed Models Analysis|||Month 15||16.46|11.49|<0.0001
73890040|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.53|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|60.0|10.71|16.34|||Mixed Models Analysis|||Month 18||16.34|10.71|<0.0001
73890041|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.56|STANDARD_ERROR_OF_MEAN|3.43||0.0009|TWO_SIDED|60.0|8.67|14.45|||Mixed Models Analysis|||Month 18||14.45|8.67|0.0009
73890042|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.63|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|60.0|12.72|18.53|||Mixed Models Analysis|||Month 24||18.53|12.72|<0.0001
73890043|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.89|STANDARD_ERROR_OF_MEAN|3.54||0.001|TWO_SIDED|60.0|8.91|14.88|||Mixed Models Analysis|||Month 24||14.88|8.91|0.0010
73890044|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.29|STANDARD_ERROR_OF_MEAN|3.86|<|0.0001|TWO_SIDED|60.0|16.03|22.55|||Mixed Models Analysis|||Month 30||22.55|16.03|<0.0001
73890045|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.63|STANDARD_ERROR_OF_MEAN|3.97||0.0082|TWO_SIDED|60.0|7.27|13.98|||Mixed Models Analysis|||Month 30||13.98|7.27|0.0082
73890046|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.72|STANDARD_ERROR_OF_MEAN|4.31||0.0008|TWO_SIDED|60.0|11.09|18.36|||Mixed Models Analysis|||Month 36||18.36|11.09|0.0008
73890047|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|4.43||0.0462|TWO_SIDED|60.0|5.16|12.64|||Mixed Models Analysis|||Month 36||12.64|5.16|0.0462
73890048|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.7|STANDARD_ERROR_OF_MEAN|4.25||0.0007|TWO_SIDED|60.0|11.11|18.28|||Mixed Models Analysis|||Month 42||18.28|11.11|0.0007
73890049|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.55|STANDARD_ERROR_OF_MEAN|4.37||0.0519|TWO_SIDED|60.0|4.87|12.24|||Mixed Models Analysis|||Month 42||12.24|4.87|0.0519
73890050|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.58|STANDARD_ERROR_OF_MEAN|4.65||0.0039|TWO_SIDED|60.0|9.66|17.5|||Mixed Models Analysis|||Month 48||17.50|9.66|0.0039
73890051|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.12|STANDARD_ERROR_OF_MEAN|4.78||0.058|TWO_SIDED|60.0|5.09|13.15|||Mixed Models Analysis|||Month 48||13.15|5.09|0.0580
73890052|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.61|STANDARD_ERROR_OF_MEAN|4.74||0.0006|TWO_SIDED|60.0|12.62|20.61|||Mixed Models Analysis|||Month 54||20.61|12.62|0.0006
73890053|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.15|STANDARD_ERROR_OF_MEAN|4.87||0.0136|TWO_SIDED|60.0|8.04|16.26|||Mixed Models Analysis|||Month 54||16.26|8.04|0.0136
73890054|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.39|STANDARD_ERROR_OF_MEAN|4.74||0.0053|TWO_SIDED|60.0|9.39|17.39|||Mixed Models Analysis|||Month 60||17.39|9.39|0.0053
73890055|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.77|STANDARD_ERROR_OF_MEAN|4.87||0.0736|TWO_SIDED|60.0|4.66|12.88|||Mixed Models Analysis|||Month 60||12.88|4.66|0.0736
73890056|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.63|STANDARD_ERROR_OF_MEAN|4.8||0.005|TWO_SIDED|60.0|9.58|17.67|||Mixed Models Analysis|||Month 66||17.67|9.58|0.0050
73890057|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.77|STANDARD_ERROR_OF_MEAN|4.93||0.0491|TWO_SIDED|60.0|5.61|13.93|||Mixed Models Analysis|||Month 66||13.93|5.61|0.0491
73890058|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.66|STANDARD_ERROR_OF_MEAN|5.04||0.0041|TWO_SIDED|60.0|10.4|18.91|||Mixed Models Analysis|||Month 72||18.91|10.40|0.0041
73890059|NCT00658359|147312473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.59|STANDARD_ERROR_OF_MEAN|5.19||0.066|TWO_SIDED|60.0|5.22|13.97|||Mixed Models Analysis|||Month 72||13.97|5.22|0.0660
73890060|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|1.73||0.2393|TWO_SIDED|95.0|-5.45|1.36|||Mixed Models Analysis|||Month 24: Physical Functioning||1.36|-5.45|0.2393
73890061|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57|STANDARD_ERROR_OF_MEAN|1.89||0.0595|TWO_SIDED|95.0|-7.29|0.14|||Mixed Models Analysis|||Month 24: Physical Functioning||0.14|-7.29|0.0595
73890062|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|2.1||0.5182|TWO_SIDED|95.0|-2.77|5.49|||Mixed Models Analysis|||Month 24: Role Physical||5.49|-2.77|0.5182
73890063|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|2.3||0.3938|TWO_SIDED|95.0|-6.49|2.56|||Mixed Models Analysis|||Month 24: Role Physical||2.56|-6.49|0.3938
73890064|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|2.12||0.8932|TWO_SIDED|95.0|-3.89|4.46|||Mixed Models Analysis|||Month 24: Bodily Pain||4.46|-3.89|0.8932
73890065|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|2.33||0.9673|TWO_SIDED|95.0|-4.48|4.67|||Mixed Models Analysis|||Month 24: Bodily Pain||4.67|-4.48|0.9673
73890066|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|1.78||0.329|TWO_SIDED|95.0|-1.76|5.23|||Mixed Models Analysis|||Month 24: General Health||5.23|-1.76|0.3290
73890067|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_ERROR_OF_MEAN|1.95||0.578|TWO_SIDED|95.0|-2.75|4.92|||Mixed Models Analysis|||Month 24: General Health||4.92|-2.75|0.5780
73890068|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.87||0.9799|TWO_SIDED|95.0|-3.72|3.62|||Mixed Models Analysis|||Month 24: Vitality||3.62|-3.72|0.9799
73890069|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|2.07||0.396|TWO_SIDED|95.0|-2.31|5.83|||Mixed Models Analysis|||Month 24: Vitality||5.83|-2.31|0.3960
73890070|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|1.98||0.94|TWO_SIDED|95.0|-4.05|3.75|||Mixed Models Analysis|||Month 24: Social Functioning||3.75|-4.05|0.9400
73890071|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|2.2||0.8583|TWO_SIDED|95.0|-3.94|4.72|||Mixed Models Analysis|||Month 24: Social Functioning||4.72|-3.94|0.8583
73890072|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.82|STANDARD_ERROR_OF_MEAN|2.31||0.0997|TWO_SIDED|95.0|-0.73|8.37|||Mixed Models Analysis|||Month 24: Role Emotional||8.37|-0.73|0.0997
73890073|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|2.54||0.852|TWO_SIDED|95.0|-5.47|4.52|||Mixed Models Analysis|||Month 24: Role Emotional||4.52|-5.47|0.8520
73890074|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|2.01||0.4023|TWO_SIDED|95.0|-5.64|2.27|||Mixed Models Analysis|||Month 24: Mental Health||2.27|-5.64|0.4023
73890075|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|2.22||0.1092|TWO_SIDED|95.0|-0.8|7.92|||Mixed Models Analysis|||Month 24: Mental Health||7.92|-0.80|0.1092
73890076|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.16||0.1754|TWO_SIDED|95.0|-0.1|0.52|||Mixed Models Analysis|||Month 24: TR Scale Score||0.52|-0.10|0.1754
73890077|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.1802|TWO_SIDED|95.0|-0.11|0.57|||Mixed Models Analysis|||Month 24: TR Scale Score||0.57|-0.11|0.1802
73890078|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|1.68||0.9966|TWO_SIDED|95.0|-3.31|3.29|||Mixed Models Analysis|||Month 24: Physical Component Summary||3.29|-3.31|0.9966
73890079|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.84||0.188|TWO_SIDED|95.0|-6.04|1.19|||Mixed Models Analysis|||Month 24: Physical Component Summary||1.19|-6.04|0.1880
73890080|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.92||0.6154|TWO_SIDED|95.0|-2.81|4.73|||Mixed Models Analysis|||Month 24: Mental Component Summary||4.73|-2.81|0.6154
73890081|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|2.12||0.1248|TWO_SIDED|95.0|-0.91|7.43|||Mixed Models Analysis|||Month 24: Mental Component Summary||7.43|-0.91|0.1248
73890082|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|2.03||0.4174|TWO_SIDED|95.0|-5.63|2.34|||Mixed Models Analysis|||Month 36: Physical Functioning||2.34|-5.63|0.4174
73890083|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44|STANDARD_ERROR_OF_MEAN|2.6||0.3486|TWO_SIDED|95.0|-7.54|2.66|||Mixed Models Analysis|||Month 36: Physical Functioning||2.66|-7.54|0.3486
73890084|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|2.47||0.8335|TWO_SIDED|95.0|-4.33|5.37|||Mixed Models Analysis|||Month 36: Role Physical||5.37|-4.33|0.8335
73890085|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.18||0.5291|TWO_SIDED|95.0|-8.24|4.24|||Mixed Models Analysis|||Month 36: Role Physical||4.24|-8.24|0.5291
73890086|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|2.5||0.4033|TWO_SIDED|95.0|-2.82|7.0|||Mixed Models Analysis|||Month 36: Bodily Pain||7.00|-2.82|0.4033
73890087|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|3.24||0.9078|TWO_SIDED|95.0|-6.74|5.99|||Mixed Models Analysis|||Month 36: Bodily Pain||5.99|-6.74|0.9078
73890088|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|2.08||0.3947|TWO_SIDED|95.0|-2.31|5.86|||Mixed Models Analysis|||Month 36: General Health||5.86|-2.31|0.3947
73890089|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.66||0.7165|TWO_SIDED|95.0|-4.26|6.2|||Mixed Models Analysis|||Month 36: General Health||6.20|-4.26|0.7165
73890090|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|2.19||0.5112|TWO_SIDED|95.0|-2.87|5.75|||Mixed Models Analysis|||Month 36: Vitality||5.75|-2.87|0.5112
73890091|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|2.86||0.1218|TWO_SIDED|95.0|-1.18|10.04|||Mixed Models Analysis|||Month 36: Vitality||10.04|-1.18|0.1218
73890092|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47|STANDARD_ERROR_OF_MEAN|2.33||0.2895|TWO_SIDED|95.0|-2.11|7.05|||Mixed Models Analysis|||Month 36: Social Functioning||7.05|-2.11|0.2895
73890093|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|3.03||0.8349|TWO_SIDED|95.0|-6.58|5.32|||Mixed Models Analysis|||Month 36: Social Functioning||5.32|-6.58|0.8349
73890094|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.62|STANDARD_ERROR_OF_MEAN|2.72||0.0393|TWO_SIDED|95.0|0.28|10.97|||Mixed Models Analysis|||Month 36: Role Emotional||10.97|0.28|0.0393
73890095|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|3.52||0.7266|TWO_SIDED|95.0|-5.69|8.16|||Mixed Models Analysis|||Month 36: Role Emotional||8.16|-5.69|0.7266
73890096|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|STANDARD_ERROR_OF_MEAN|2.36||0.4916|TWO_SIDED|95.0|-3.02|6.27|||Mixed Models Analysis|||Month 36: Mental Health||6.27|-3.02|0.4916
73890097|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|3.05||0.9008|TWO_SIDED|95.0|-5.62|6.38|||Mixed Models Analysis|||Month 36: Mental Health||6.38|-5.62|0.9008
73890098|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2965|TWO_SIDED|95.0|-0.17|0.55|||Mixed Models Analysis|||Month 36: TR Scale Score||0.55|-0.17|0.2965
73890099|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.24||0.1147|TWO_SIDED|95.0|-0.09|0.84|||Mixed Models Analysis|||Month 36: TR Scale Score||0.84|-0.09|0.1147
73890100|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|1.97||0.7786|TWO_SIDED|95.0|-4.42|3.31|||Mixed Models Analysis|||Month 36: Physical Component Summary||3.31|-4.42|0.7786
73890101|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|2.53||0.5582|TWO_SIDED|95.0|-6.45|3.49|||Mixed Models Analysis|||Month 36: Physical Component Summary||3.49|-6.45|0.5582
73890102|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|2.25||0.0727|TWO_SIDED|95.0|-0.37|8.47|||Mixed Models Analysis|||Month 36: Mental Component Summary||8.47|-0.37|0.0727
73890103|NCT00658359|147312474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|2.91||0.3264|TWO_SIDED|95.0|-2.86|8.59|||Mixed Models Analysis|||Month 36: Mental Component Summary||8.59|-2.86|0.3264
73890104|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.11||0.3093|TWO_SIDED|95.0|-0.1|0.33|||Mixed Models Analysis|||Month 24 Limited Physical Capacity||0.33|-0.10|0.3093
73890105|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.12||0.3223|TWO_SIDED|95.0|-0.12|0.36|||Mixed Models Analysis|||Month 24 Limited Physical Capacity||0.36|-0.12|0.3223
73890106|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.11||0.4858|TWO_SIDED|95.0|-0.14|0.3|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity||0.30|-0.14|0.4858
73890107|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.13||0.3679|TWO_SIDED|95.0|-0.13|0.36|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity||0.36|-0.13|0.3679
73890108|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6416|TWO_SIDED|95.0|-0.27|0.17|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction||0.17|-0.27|0.6416
73890109|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.4241|TWO_SIDED|95.0|-0.34|0.14|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction||0.14|-0.34|0.4241
73890110|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.12||0.2133|TWO_SIDED|95.0|-0.09|0.39|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids||0.39|-0.09|0.2133
73890111|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1918|TWO_SIDED|95.0|-0.09|0.44|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids||0.44|-0.09|0.1918
73890112|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.55|-0.14|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair||-0.14|-0.55|0.0010
73890113|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.59|-0.13|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair||-0.13|-0.59|0.0020
73890114|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.12||0.2012|TWO_SIDED|95.0|-0.08|0.4|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress||0.40|-0.08|0.2012
73890115|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8986|TWO_SIDED|95.0|-0.25|0.29|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress||0.29|-0.25|0.8986
73890116|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.08||0.6724|TWO_SIDED|95.0|-0.13|0.2|||Mixed Models Analysis|||Month 24 Global Score||0.20|-0.13|0.6724
73890117|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.9297|TWO_SIDED|95.0|-0.18|0.19|||Mixed Models Analysis|||Month 24 Global Score||0.19|-0.18|0.9297
73890118|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8682|TWO_SIDED|95.0|-0.28|0.23|||Mixed Models Analysis|||Month 36 Limited Physical Capacity||0.23|-0.28|0.8682
73890119|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.18||0.3392|TWO_SIDED|95.0|-0.18|0.53|||Mixed Models Analysis|||Month 36 Limited Physical Capacity||0.53|-0.18|0.3392
73890120|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.6545|TWO_SIDED|95.0|-0.2|0.32|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity||0.32|-0.20|0.6545
73890121|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.19||0.3253|TWO_SIDED|95.0|-0.18|0.55|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity||0.55|-0.18|0.3253
73890122|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.9698|TWO_SIDED|95.0|-0.26|0.25|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction||0.25|-0.26|0.9698
73890123|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3065|TWO_SIDED|95.0|-0.17|0.54|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction||0.54|-0.17|0.3065
73890124|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7147|TWO_SIDED|95.0|-0.33|0.23|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids||0.23|-0.33|0.7147
73890125|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.2||0.4852|TWO_SIDED|95.0|-0.25|0.53|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids||0.53|-0.25|0.4852
73890126|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.13||0.0888|TWO_SIDED|95.0|-0.46|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair||0.03|-0.46|0.0888
73890127|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.0719|TWO_SIDED|95.0|-0.65|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair||0.03|-0.65|0.0719
73890128|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7531|TWO_SIDED|95.0|-0.24|0.33|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress||0.33|-0.24|0.7531
73890129|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.6412|TWO_SIDED|95.0|-0.49|0.3|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress||0.30|-0.49|0.6412
73890130|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1||0.9186|TWO_SIDED|95.0|-0.2|0.18|||Mixed Models Analysis|||Month 36 Global Score||0.18|-0.20|0.9186
73890131|NCT00658359|147312475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6629|TWO_SIDED|95.0|-0.21|0.33|||Mixed Models Analysis|||Month 36 Global Score||0.33|-0.21|0.6629
73890132|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|1.72||0.2826|TWO_SIDED|95.0|-5.22|1.53|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score||1.53|-5.22|0.2826
73890133|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_ERROR_OF_MEAN|1.97||0.5371|TWO_SIDED|95.0|-2.65|5.09|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score||5.09|-2.65|0.5371
73890134|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7503|TWO_SIDED|95.0|-1.41|1.02|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score||1.02|-1.41|0.7503
73890135|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.72||0.261|TWO_SIDED|95.0|-0.6|2.21|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score||2.21|-0.60|0.2610
73890136|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.98||0.3656|TWO_SIDED|95.0|-1.04|2.82|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score||2.82|-1.04|0.3656
73890137|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|1.15||0.4405|TWO_SIDED|95.0|-3.16|1.37|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score||1.37|-3.16|0.4405
73890138|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.96||0.4135|TWO_SIDED|95.0|-5.45|2.25|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score||2.25|-5.45|0.4135
73890139|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.75||0.7272|TWO_SIDED|95.0|-4.45|6.37|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score||6.37|-4.45|0.7272
73890140|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.71||0.8111|TWO_SIDED|95.0|-1.56|1.22|||Mixed Models Analysis|||Month 36 Non-Pain symptoms Converted Score||1.22|-1.56|0.8111
73890141|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.02||0.2636|TWO_SIDED|95.0|-0.86|3.13|||Mixed Models Analysis|||Month 36 Non-Pain Symptoms Converted Score||3.13|-0.86|0.2636
73890142|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.13||0.689|TWO_SIDED|95.0|-1.77|2.67|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score||2.67|-1.77|0.6890
73890143|NCT00658359|147312476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|1.62||0.4853|TWO_SIDED|95.0|-4.31|2.05|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score||2.05|-4.31|0.4853
73890144|NCT02754440|147312479|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 5.0 × 10\^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
73890145|NCT02754440|147312479|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 8.0 × 10\^6 for the double platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
73890146|NCT02754440|147312479|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 12.0 × 10\^6 for the triple platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
73890147|NCT02754440|147312480|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10\^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.957|STANDARD_ERROR_OF_MEAN|0.021|||ONE_SIDED|95.0|0.904|||||||Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.904|
73890148|NCT02754440|147312480|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10\^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
73890149|NCT02754440|147312480|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10\^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
73890150|NCT01189032|147312486|SUPERIORITY_OR_OTHER|||||||0.004||||||It's the p-value of linear trend. It's adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).||||||0.004
73890151|NCT01189032|147312486|SUPERIORITY_OR_OTHER|||||||0.006||||||It's the p-value of Saturated at 1% DE-089. It's adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).||||||0.006
73890152|NCT00363480|147312503|SUPERIORITY_OR_OTHER||Percentage diffrence|-30.6|||<|0.0001|TWO_SIDED|95.0|-37.89|-23.29|||McNemar|||Comparison between GOAL and ACT response||-23.29|-37.89|<0.0001
73890153|NCT00363480|147312504|SUPERIORITY_OR_OTHER||t-Distribution|50.2|||||TWO_SIDED|95.0|43.15|57.32||||||||57.32|43.15|
73890154|NCT06042855|147312543|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.89|1.03|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.03|0.89|
73890155|NCT06042855|147312544|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.32|6.38||||||No hypothesis test or decision rule was evaluated.||6.38|0.32|
73890156|NCT06042855|147312547|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.82|1.78|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.78|0.82|
73890157|NCT06042855|147312548|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.66|1.31|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.31|0.66|
73890158|NCT06042855|147312549|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.57|1.41|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.41|0.57|
73890159|NCT06042855|147312550|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.78|1.42|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.42|0.78|
73890160|NCT06042855|147312558|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|0.03|||||TWO_SIDED|95.0|-0.21|0.28|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.28|-0.21|
73890161|NCT06042855|147312559|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimate time unwell|-0.04|||||TWO_SIDED|95.0|-0.34|0.26|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.26|-0.34|
73890162|NCT02129699|147312566|SUPERIORITY|Pre-specified analysis|Hazard Ratio (HR)|0.96||||0.355|TWO_SIDED|95.0|0.78|1.19|||Regression, Cox|Cox regression model for treatment effect, analysis adjusted for stratification factors||||1.19|0.78|0.355
73890163|NCT02129699|147312567|SUPERIORITY|Pre-specified analysis|Hazard Ratio (HR)|0.99||||0.459|TWO_SIDED|95.0|0.82|1.19|||Regression, Cox|||||1.19|0.82|0.459
73890164|NCT00525161|147312577|SUPERIORITY_OR_OTHER||Clinical Response Rate at 3 months|0.0|||||TWO_SIDED||||||||Defined as complete response/partial response after 3 months of adding sorafenib to endocrine therapy|Based on known historical response rate to sorafenib of no better than 5-10%, the study was designed to test the null hypothesis that the clinical response rate is no better than 10% versus the alternative hypothesis that it is at least 25% when sorafenib is added to endocrine therapy. In the first stage, 18 patients were planned for enrollment, and if two or fewer responses were observed, the trial would be terminated. The study stopped after 11 due to slow accrual and withdrawal of funding.||||
73890165|NCT00525161|147312578|SUPERIORITY_OR_OTHER||Median Progression Free Survival|6.1|||||TWO_SIDED|95.0|2.6|11.3||||||||11.3|2.6|
73890166|NCT03848728|147312596|SUPERIORITY||Risk Ratio (RR)|1.1||||0.0019|TWO_SIDED|95.0|1.03|1.16|||TMLE|||||1.16|1.03|0.0019
73890167|NCT00630838|147312604|SUPERIORITY_OR_OTHER||||||=|0.897|TWO_SIDED||||||t-test, 2 sided|||||||=0.897
73890168|NCT02581410|147312616|NON_INFERIORITY|Non-inferiority will be demonstrated if the upper limit of the two-sided 95% confidence interval of the adjusted geometric mean concentration (GMC) ratio (No prev- Zvax over Prev-Zvax) 1 month post-dose 2 is below 1.5 in terms of anti-gE antibodies.|Adjusted GMC ratio|1.04|||||TWO_SIDED|95.0|0.92|1.17|||ANCOVA|||To compare humoral immune responses at 1 month after dose 2 of GSK1437173A (Month 3) in subjects ≥ 65 years of age who received Zostavax ≥ 5 years earlier (Prev-Zvax) as compared to subjects who have never received Zostavax (No prev-Zvax).||1.17|0.92|
73890169|NCT01424072|147312637|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0.023
73890170|NCT01424072|147312638|SUPERIORITY_OR_OTHER||||||,|0||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|This result was only to the domain Social Support.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days) and at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0,022
73890171|NCT01424072|147312639|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0.039
73890172|NCT01424072|147312639|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||ANOVA|It was carried out the analysis of variance (ANOVA) among the groups at the follow up and then it was used the post hoc test.||Coping Strategy: Confrontation domain||||0.029
73890173|NCT02000115|147312655|NON_INFERIORITY|8.0% non-inferiority margin|Difference in percentages between groups|1.5||||0.006|ONE_SIDED|95.0||5.7||p for non-inferiority|Kaplan-Meier estimates|Kaplan-Meier was used as the method for calculating the endpoint rate|Non-inferiority of the Portico valve to commercially available valves was shown if the upper bound of the 95% confidence interval (1-sided) for the difference in event rates between groups was less than the non-inferiority margin (8·0%)|We analysed the primary effectiveness endpoint in the intention-to- treat (ITT) population using the Kaplan-Meier method to estimate event rates, the Greenwood method to calculate the standard error of the Kaplan-Meier estimates, and assuming an asymptotic normal distribution for event rate estimates.||5.7||0.006
73890174|NCT02000115|147312656|NON_INFERIORITY|8.5% non-inferiority margin|Difference in percentages between groups|4.2||||0.03|ONE_SIDED|95.0||8.1||p for non-inferiority|Kaplan-Meier estimates|Kaplan-Meier was used as the method for calculating the endpoint rate|Non-inferiority of the Portico valve to commercially available valves was shown if the upper bound of the 95% confidence interval (1-sided) for the difference in event rates between groups was less than the non-inferiority margin (8·5%)|We analysed the primary safety endpoint in the intention-to-treat (ITT) population using the Kaplan-Meier method to estimate event rates, the Greenwood method to calculate the standard error of the Kaplan-Meier estimates, and assuming an asymptotic normal distribution for event rate estimates.||8.1||0.03
73890175|NCT02000115|147312658|NON_INFERIORITY|non-inferiority margin of 4%|Difference in percentages between groups|0.4||||0.001|ONE_SIDED|95.0||2.3||p for non-inferiority|Farrington-Manning test|The test statistic is based on the Farrington-Manning method of testing non-inferiority of proportions.|If the upper limit of the 95% confidence interval (1-sided) for the difference of proportions (Portico - CAV) is \< 4%, then non inferiority is demonstrated.|||2.3||0.001
73890176|NCT02000115|147312659|NON_INFERIORITY|non-inferiority margin of 10 points|Mean Difference (Final Values)|-0.5|||<|0.0001|ONE_SIDED|95.0|-3.5|||p for non-inferiority|two-sample t-test|The test statistic is based on two sample t-test|If the lower limit of the 95% confidence interval (1-sided) for the difference of (Portico - CAV) is \> -10, then non inferiority is demonstrated.||||-3.5|<0.0001
73890177|NCT02000115|147312660|NON_INFERIORITY|non-inferiority margin of 6%|Difference in percentages between groups|5.6||||0.4|ONE_SIDED|95.0||8.5||p for non-inferiority|Farrington-Manning test|The test statistic is based on the Farrington-Manning method of testing non-inferiority of proportions|If the upper limit of the 95% confidence interval (1-sided) for the difference of proportions (Portico - CAV) is \< 6%, then non inferiority is demonstrated.|||8.5||0.40
73890178|NCT02000115|147312661|NON_INFERIORITY|non-inferiority margin on -36 meters|Mean Difference (Final Values)|3.5||||0.0003|ONE_SIDED|95.0|-15.4|||p for non-inferiority|two sample t-test|The test statistic is based on a two-sample t-test|If the lower limit of the 95% confidence interval (1-sided) for the difference of (Portico - CAV) is \> -36, then non inferiority is demonstrated.||||-15.4|0.0003
73890179|NCT05006573|147312664|SUPERIORITY||Risk Ratio (RR)|1.14||||0.5911|TWO_SIDED|95.0|0.71|1.82|||negative binomial model|marginal standardization method|The rate ratio (Benralizumab/Placebo) and its 95% CI are estimated using a negative binomial model. The covariates include treatment arm, baseline blood eosinophil category, and number of exacerbations from previous year.|||1.82|0.71|0.5911
73890180|NCT05006573|147312665|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.6677|TWO_SIDED|95.0|0.67|1.91|||Regression, Cox||The analysis is performed using cox proportional hazards model with covariates of treatment group, number of exacerbations in previous year and baseline eosinophil category.|||1.91|0.67|0.6677
73890181|NCT05462756|147312710|NON_INFERIORITY|The sample size provided \>99% statistical power to show noninferiority assuming a 0.4% noninferiority margin (NIM), in insulin efsitora doses compared to insulin glargine, in a 1:1 randomization, a standard deviation (SD) of 1.1%, and a dropout rate of 15%.|LS Mean Difference|-0.012|||||TWO_SIDED|95.0|-0.14|0.116||||||Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.||0.116|-0.140|
73890182|NCT05462756|147312711|SUPERIORITY||LS Mean Difference|-0.012||||0.855|TWO_SIDED|95.0|-0.14|0.116|||ANCOVA|||Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.||0.116|-0.140|0.855
73890183|NCT05462756|147312712|SUPERIORITY||Odds Ratio (OR)|1.11||||0.504|TWO_SIDED|95.0|0.81|1.52|||Chi-squared|||||1.52|0.81|0.504
73890184|NCT05462756|147312713|SUPERIORITY||Relative rate|0.67||||0.058|TWO_SIDED|95.0|0.44|1.01|||Negative binomial model||Relative rate is the ratio of the group means (Insulin Efsitora vs Insulin Glargine).|Group mean is determined by Negative Binomial Model using Number of episodes = Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.||1.01|0.44|0.058
73890185|NCT05462756|147312714|SUPERIORITY||LS Mean Difference|-4.29||||0.104|TWO_SIDED|95.0|-9.461|0.886|||ANCOVA|||LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||0.886|-9.461|0.104
73890186|NCT05462756|147312715|SUPERIORITY||LS Mean Difference|1.35||||0.337|TWO_SIDED|95.0|-1.404|4.101|||ANCOVA|||LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||4.101|-1.404|0.337
73890187|NCT05462756|147312716|SUPERIORITY||LS Mean Difference|1.59||||0.104|TWO_SIDED|95.0|-0.327|3.508|||ANCOVA|||LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||3.508|-0.327|0.104
73890188|NCT05462756|147312717|SUPERIORITY||LS Mean Difference|-1.5||||0.304|TWO_SIDED|95.0|-4.358|1.36|||ANCOVA|||LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares). Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||1.360|-4.358|0.304
73890189|NCT05462756|147312718|SUPERIORITY||LS Mean Difference|0.23||||0.523|TWO_SIDED|95.0|-0.48|0.95|||Mixed Models Analysis|||LS Mean was determined by MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Unstructured variance-covariance structure was used.||0.95|-0.48|0.523
73890190|NCT05462756|147312719|SUPERIORITY||LS Mean Difference|-35.04|||<|0.001|TWO_SIDED|95.0|-55.57|-14.5|||Mixed Models Analysis|||LS Mean was determined by Mixed Model Repeated Measures (MMRM) model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-14.50|-55.57|<0.001
73890191|NCT05462756|147312720|SUPERIORITY||LS Mean Difference|-7.55|||<|0.001|TWO_SIDED|95.0|-10.79|-4.3|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-4.30|-10.79|<0.001
73890192|NCT05462756|147312721|SUPERIORITY||LS Mean Difference|-73.5|||<|0.001|TWO_SIDED|95.0|-107.81|-39.2|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-39.20|-107.81|<0.001
73890193|NCT05462756|147312722|SUPERIORITY||LS Mean Difference|3.53|||<|0.001|TWO_SIDED|95.0|1.49|5.58|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||5.58|1.49|<0.001
73890194|NCT05462756|147312723|SUPERIORITY||Mean Difference (Net)|1.11||||0.442|TWO_SIDED|95.0|0.85|1.44|||Negative binomial model|||Group mean was reported and determined by Negative binomial method using Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables.||1.44|0.85|0.442
73890195|NCT05462756|147312724|SUPERIORITY||LS Mean Difference|0.14||||0.543|TWO_SIDED|95.0|-0.32|0.6|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.60|-0.32|0.543
73890196|NCT05462756|147312725|SUPERIORITY||LS Mean Difference|1.8||||0.099|TWO_SIDED|95.0|-0.3|4.0|||ANCOVA|||LS Mean was determined by ANCOVA model using Country + Personal Use CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables.||4.0|-0.3|0.099
73890197|NCT00990704|147312726|SUPERIORITY_OR_OTHER||Difference between arms in percentage|13.6||||0.518|TWO_SIDED|95.0|-22.36|49.63|||Fisher Exact|||||49.63|-22.36|0.518
73890198|NCT04040933|147312734|OTHER|Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.86|TWO_SIDED||||||ANCOVA|||||||0.860
73890199|NCT04040933|147312734|OTHER|Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.051|||||||ANCOVA|||||||0.051
73890200|NCT04040933|147312735|OTHER|Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.259|TWO_SIDED||||||ANCOVA|||||||0.259
73890201|NCT04040933|147312735|OTHER|Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.451|||||||ANCOVA|||||||0.451
73890202|NCT04040933|147312736|OTHER|Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.|||||>|0.999|TWO_SIDED||||||ANCOVA|||||||>0.999
73890203|NCT04040933|147312736|OTHER|Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.739|||||||ANCOVA|||||||0.739
73890204|NCT04040933|147312737|OTHER|Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.|||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
73890205|NCT04040933|147312737|OTHER|Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.053|||||||ANCOVA|||||||0.053
73890206|NCT04040933|147312738|OTHER|Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.666|TWO_SIDED||||||ANCOVA|||||||0.666
73890207|NCT04040933|147312738|OTHER|Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.473|||||||ANCOVA|||||||0.473
73890208|NCT04040933|147312739|OTHER|Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.761|TWO_SIDED||||||ANCOVA|||||||0.761
73890209|NCT04040933|147312739|OTHER|Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.456|||||||ANCOVA|||||||0.456
73890210|NCT04040933|147312740|OTHER|Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.019|TWO_SIDED||||||ANCOVA|||||||0.019
73890211|NCT04040933|147312740|OTHER|Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.325|||||||ANCOVA|||||||0.325
73890212|NCT04040933|147312741|OTHER|Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.|||||<|0.001|TWO_SIDED|||||no adjustments|Boot-strap sampling method|||All hypothesis tests was conducted at 0.05 level without adjustment of multiple comparisons||||<0.001
73890213|NCT04040933|147312741|OTHER|Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.|||||<|0.001||||||no adjustments|Boot-strap sampling method|||||||<0.001
73890214|NCT00904033|147312783|OTHER|||||||0.86|||||||ANCOVA|Main Effects Results only for No Exercise vs Exercise||||||0.86
73890215|NCT00904033|147312784|OTHER|||||||0.19|||||||ANCOVA|||||||0.19
73890216|NCT00904033|147312785|OTHER|||||||0.49|||||||ANCOVA|||||||0.49
73890217|NCT00904033|147312786|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
73890218|NCT00904033|147312787|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
73890219|NCT00904033|147312788|OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
73890220|NCT00904033|147312789|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
73890221|NCT00904033|147312790|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
73890222|NCT00118417|147312815|SUPERIORITY_OR_OTHER|||||||0||95.0||||Paired t-test between endpoint and baseline PDSS|t-test, 2 sided|Degrees of Freedom = 38||||||0.0000
73890223|NCT00118417|147312816|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||T-test of PDSS change score|t-test, 2 sided|Degrees of Freedom = 22||||||0.97
73890224|NCT00118417|147312817|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||T-test of PDSS change between baseline and endpoint of Phase 3|t-test, 2 sided|Degrees of Freedom = 17||||||0.061
73890225|NCT01383356|147312818|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|Geometric mean ratio (GMR) in percent|118.0|||||TWO_SIDED|90.0|111.0|125.0|||||Lina/Met 2.5mg/500mg versus (vs.) Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the geometric mean ratio is contained within the 80 to 125 percent range both on measured data (statistical analysis 1) and on potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||125|111|
73890226|NCT01383356|147312818|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|GMR, potency corrected (percent)|122.0|||||TWO_SIDED|90.0|114.0|130.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of drug potency (DP) of Met in single tablet and DP of Met in combination tablet).||130|114|
73890227|NCT01383356|147312819|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the 90 percent confidence interval of geometric mean ratio is entirely contained within the 80 to125 percent range both on measured data (statistical analysis 1) and potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||108|101|
73890228|NCT01383356|147312819|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs.Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).||112|105|
73890229|NCT01383356|147312820|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE), AUC0-inf was no BE criteria|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||108|101|
73890230|NCT01383356|147312820|NON_INFERIORITY_OR_EQUIVALENCE|BE, AUC0-inf was no BE criteria|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).||112|105|
73890231|NCT02350296|147312831|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|108.12||||0.1455|TWO_SIDED|94.12|97.57|119.81||"treatment P value reported"|ANOVA||Estimated value and limits are expressed in %|||119.81|97.57|0.1455
73890232|NCT02350296|147312832|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|110.62||||0.0023|TWO_SIDED|94.12|104.26|117.38||"Treatment P value is reported"|ANOVA||Estimated value and limits are expressed in %|||117.38|104.26|0.0023
73890233|NCT02350296|147312833|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|110.69||||0.0021|TWO_SIDED|94.12|104.35|117.41||"treatment P value is reported"|ANOVA||Estimated value and limits are expressed in %|||117.41|104.35|0.0021
73890234|NCT02350296|147312834|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.||||||0.0201|||||||Friedman|||||||0.0201
73890235|NCT01544335|147312838|OTHER||||||<|0.001|||||||Correlation coefficient|The correlation between RVC and ΔL-Dex values was plotted, and the correlation strength was assessed using the Pearson correlation coefficient, r.||||||<0.001
73890236|NCT03219528|147312840|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||Baseline||||0.78
73890237|NCT03219528|147312840|SUPERIORITY|||||||0.88|||||||Mixed Models Analysis|||Week 5||||0.88
73890238|NCT03219528|147312849|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Baseline||||0.77
73890239|NCT03219528|147312849|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||Week 5||||0.58
73890240|NCT02120898|147312858|EQUIVALENCE|90% CI interval was -0.20 to +0.20 for therapeutic equivalence.|Percentage difference|-1.16||||0.0702|TWO_SIDED|90.0|-7.93|5.62|||Fisher Exact|||Analysis was performed using 90% Wald's confidence interval (CI) with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.||5.62|-7.93|0.0702
73890241|NCT02120898|147312859|SUPERIORITY||Percentage difference|0.14||||0.0318|TWO_SIDED|90.0|-6.08|6.35||Threshold for significance at 0.05 level.|Fisher Exact|||Analysis was performed using 90% Wald's CI with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.||6.35|-6.08|0.0318
73890242|NCT02919995|147312879|OTHER||Contrast ratio|1.038||||0.0196|TWO_SIDED|95.0|1.007|1.07|||ANCOVA|||||1.07|1.007|0.0196
73890243|NCT02919995|147312879|OTHER||Contrast ratio|1.024||||0.0802|TWO_SIDED|95.0|0.997|1.052|||ANCOVA|||||1.052|0.997|0.0802
73890244|NCT02919995|147312879|OTHER||Contrast ratio|0.986||||0.3487|TWO_SIDED|95.0|0.957|1.017|||ANCOVA|||||1.017|0.957|0.3487
73890245|NCT02919995|147312880|OTHER||Contrast ratio|1.072||||0.0043|TWO_SIDED|95.0|1.026|1.12|||ANCOVA|||||1.12|1.026|0.0043
73890246|NCT02919995|147312880|OTHER||Contrast ratio|1.055||||0.0109|TWO_SIDED|95.0|1.014|1.096|||ANCOVA|||||1.096|1.014|0.0109
73890247|NCT02919995|147312880|OTHER||Contrast ratio|0.984||||0.4306|TWO_SIDED|95.0|0.942|1.027|||ANCOVA|||||1.027|0.942|0.4306
73890248|NCT02919995|147312881|OTHER||Contrast ratio|1.065||||0.0064|TWO_SIDED|95.0|1.021|1.11|||ANCOVA|||||1.11|1.021|0.0064
73890249|NCT02919995|147312881|OTHER||Contrast ratio|1.049||||0.0149|TWO_SIDED|95.0|1.011|1.089|||ANCOVA|||||1.089|1.011|0.0149
73890250|NCT02919995|147312881|OTHER||Contrast ratio|0.945||||0.466|TWO_SIDED|95.0|0.945|1.027|||ANCOVA|||||1.027|0.945|0.466
73890251|NCT02919995|147312882|OTHER||Contrast ratio|1.061||||0.0093|TWO_SIDED|95.0|1.017|1.107|||ANCOVA|||||1.107|1.017|0.0093
73890252|NCT02919995|147312882|OTHER||Contrast ratio|1.042||||0.0333|TWO_SIDED|95.0|1.004|1.082|||ANCOVA|||||1.082|1.004|0.0333
73890253|NCT02919995|147312882|OTHER||Contrast ratio|0.982||||0.3693|TWO_SIDED|95.0|0.941|1.024|||ANCOVA|||||1.024|0.941|0.3693
73890254|NCT00473382|147312930|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|20.8|||<|0.0001|TWO_SIDED|95.0|11.4|30.2||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||30.2|11.4|<0.0001
73890255|NCT00473382|147312930|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|33.3|||<|0.0001|TWO_SIDED|95.0|23.8|42.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||42.8|23.8|<0.0001
73890256|NCT00473382|147312931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|||<|0.0001|TWO_SIDED|95.0|5.4|11.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||11.5|5.4|<0.0001
73890257|NCT00473382|147312931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|||<|0.0001|TWO_SIDED|95.0|6.4|13.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.3|6.4|<0.0001
73890258|NCT00473382|147312932|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|21.4||||0.0002|TWO_SIDED|95.0|10.8|31.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||31.9|10.8|0.0002
73890259|NCT00473382|147312932|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|27.1|||<|0.0001|TWO_SIDED|95.0|16.4|37.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||37.9|16.4|<0.0001
73890260|NCT00473382|147312933|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|7.1||||0.0119|TWO_SIDED|95.0|1.7|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||12.6|1.7|0.0119
73890261|NCT00473382|147312933|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|4.5||||0.1384|TWO_SIDED|95.0|-1.2|10.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||10.1|-1.2|0.1384
73890262|NCT00473382|147312934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3||||0.0102|TWO_SIDED|95.0|2.0|14.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||14.6|2.0|0.0102
73890263|NCT00473382|147312934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.0005|TWO_SIDED|95.0|5.1|17.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||17.3|5.1|0.0005
73890264|NCT00473382|147312935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-111.8|||<|0.0001|TWO_SIDED|95.0|-151.6|-72.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-72.0|-151.6|<0.0001
73890265|NCT00473382|147312935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-132.2|||<|0.0001|TWO_SIDED|95.0|-169.7|-94.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-94.8|-169.7|<0.0001
73890266|NCT00473382|147312936|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-4.3||||0.0853|TWO_SIDED|95.0|-9.3|0.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||0.8|-9.3|0.0853
73890267|NCT00473382|147312936|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-5.8||||0.0073|TWO_SIDED|95.0|-9.8|-1.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-1.7|-9.8|0.0073
73890268|NCT00473382|147312937|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|14.0||||0.0002|TWO_SIDED|95.0|6.8|21.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||21.1|6.8|0.0002
73890269|NCT00473382|147312937|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|28.3|||<|0.0001|TWO_SIDED|95.0|20.2|36.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||36.4|20.2|<0.0001
73890270|NCT00473382|147312938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.5|-1.3|<0.0001
73890271|NCT00473382|147312938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-1.0|-1.6|<0.0001
73890272|NCT01134055|147312944|SUPERIORITY_OR_OTHER|||||||0.1974||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.1974
73890273|NCT01134055|147312944|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
73890274|NCT01134055|147312944|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
73890275|NCT01134055|147312944|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
73890276|NCT01134055|147312944|SUPERIORITY_OR_OTHER|||||||0.7418||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.7418
73890277|NCT01134055|147312944|SUPERIORITY_OR_OTHER|||||||0.2429||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.2429
73890278|NCT01134055|147312944|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
73890279|NCT01134055|147312944|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
73890280|NCT01134055|147312944|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
73890281|NCT01134055|147312944|SUPERIORITY_OR_OTHER|||||||0.7673||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.7673
73890282|NCT01356277|147312992|SUPERIORITY||Odds Ratio (OR)|1.66||||0.006|TWO_SIDED|95.0|1.15|2.39|||Regression, Logistic|Unadjusted, ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.|We estimated a sample size of 75 participants per group to have 85% power to detect a 20% difference in taking adherence between groups, using 2-sided tests and setting alpha at 0.05, assuming a common standard deviation of 40%. Targeted enrollment of 176 participants accounted for 15% drop-out. Only participants with electronic pillbox data could be included. For participants who withdrew or stopped using the pillbox, all available pillbox data were included.||2.39|1.15|0.006
73890283|NCT01356277|147312993|SUPERIORITY||Odds Ratio (OR)|1.74||||0.003|TWO_SIDED|95.0|1.21|2.5|||Regression, Logistic|Unadjusted ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.|||2.50|1.21|0.003
73890284|NCT01356277|147312994|SUPERIORITY|||||||0.49|||||||Wilcoxon ranksum|||Null hypothesis was that there was no difference in the SD of tacrolimus trough levels between intervention and control.||||0.49
73890285|NCT01356277|147312995|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
73890286|NCT01356277|147312996|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
73890287|NCT01356277|147312997|SUPERIORITY|||||||0.26|||||||Chi-squared|||Rates were compared between intervention and control groups using Chi square||||0.26
73890288|NCT01356277|147312998|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||.45
73890289|NCT02721966|147313026|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.0001|TWO_SIDED|95.0|2.72|7.01|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||7.01|2.72|<.0001
73890290|NCT02721966|147313026|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.41|6.1|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||6.10|2.41|<.0001
73890291|NCT02721966|147313027|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.0001|TWO_SIDED|95.0|2.72|7.01|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||7.01|2.72|<.0001
73890292|NCT02721966|147313028|SUPERIORITY||Odds Ratio (OR)|4.71|||<|0.0001|TWO_SIDED|95.0|2.67|8.33|||Regression, Logistic|95% confidence interval for odds ratio|||Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|8.33|2.67|<.0001
73890293|NCT02721966|147313028|SUPERIORITY||Odds Ratio (OR)|5.61|||<|0.0001|TWO_SIDED|95.0|3.2|9.84|||Regression, Logistic|95% confidence interval for odds ratio|||Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|9.84|3.20|<.0001
73890294|NCT02721966|147313029|SUPERIORITY||Odds Ratio (OR)|4.5|||<|0.0001|TWO_SIDED|95.0|2.43|8.33|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|8.33|2.43|<.0001
73890295|NCT02721966|147313029|SUPERIORITY||Odds Ratio (OR)|5.57|||<|0.0001|TWO_SIDED|95.0|3.04|10.21|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|10.21|3.04|<.0001
73890296|NCT02721966|147313030|SUPERIORITY||LS Mean of Treatment Difference|-14.9|STANDARD_ERROR_OF_MEAN|2.62|<|0.0001|TWO_SIDED|95.0|-20.0|-9.7|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.7|-20.0|<.0001
73890297|NCT02721966|147313030|SUPERIORITY||LS Mean of Treatment Difference|-12.9|STANDARD_ERROR_OF_MEAN|2.59|<|0.0001|TWO_SIDED|95.0|-18.0|-7.8|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-7.8|-18.0|<.0001
73890298|NCT02721966|147313031|SUPERIORITY||LS Mean of Treatment Difference|-15.1|STANDARD_ERROR_OF_MEAN|2.71|<|0.0001|TWO_SIDED|95.0|-20.4|-9.7|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.7|-20.4|<.0001
73890299|NCT02721966|147313031|SUPERIORITY||LS Mean of Treatment Difference|-15.0|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-20.3|-9.8|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.8|-20.3|<.0001
73890300|NCT02721966|147313032|SUPERIORITY||LS Mean of Treatment Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0971|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline SPARCC index as continuous covariate.|0.1|-1.1|0.0971
73890301|NCT02721966|147313032|SUPERIORITY||LS Mean of Treatment Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0207|TWO_SIDED|95.0|-1.3|-0.1|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-0.1|-1.3|0.0207
73890302|NCT02721966|147313033|SUPERIORITY||LS Mean of Treatment Difference|-0.175|STANDARD_ERROR_OF_MEAN|0.0502||0.0005|TWO_SIDED|95.0|-0.273|-0.076|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate|-0.076|-0.273|0.0005
73890303|NCT02721966|147313033|SUPERIORITY||LS Mean of Treatment Difference|-0.234|STANDARD_ERROR_OF_MEAN|0.0497|<|0.0001|TWO_SIDED|95.0|-0.331|-0.136|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate|-0.136|-0.331|<.0001
73890304|NCT02721966|147313034|SUPERIORITY||LS Mean of Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|1.01||0.0002|TWO_SIDED|95.0|1.8|5.7|||ANCOVA|||week 12|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline FACIT Fatigue© score as continuous covariate|5.7|1.8|0.0002
73890305|NCT02721966|147313034|SUPERIORITY||LS Mean of Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|0.99||0.0007|TWO_SIDED|95.0|1.4|5.3|||ANCOVA|||week 12|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline FACIT Fatigue© score as continuous covariate|5.3|1.4|0.0007
73890306|NCT02721966|147313035|SUPERIORITY||LS Mean of Treatment Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-2.5|-0.9|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate.|-0.9|-2.5|<.0001
73890307|NCT02721966|147313035|SUPERIORITY||LS Mean of Treatment Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.4|-0.9|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate.|-0.9|-2.4|<.0001
73890308|NCT02721966|147313036|SUPERIORITY||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.31|9.95|||Regression, Logistic|95% confidence interval for odds ratio|||"Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables.~Missing ACR20 response variables were imputed by multiple imputation approach"|9.95|3.31|<.0001
73890309|NCT02721966|147313036|SUPERIORITY||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|2.83|8.16|||Regression, Logistic|95% confidence interval for odds ratio|||"Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables.~Missing ACR20 response variables were imputed by multiple imputation approach"|8.16|2.83|<.0001
73890310|NCT02157883|147313040|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|79.87|||||TWO_SIDED|90.0|73.15|87.21|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||87.21|73.15|
73890311|NCT02157883|147313041|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|124.17|||||TWO_SIDED|90.0|114.61|134.53|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||134.53|114.61|
73890312|NCT02157883|147313048|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|75.87|||||TWO_SIDED|90.0|64.18|89.69|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||89.69|64.18|
73890313|NCT02157883|147313049|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|108.25|||||TWO_SIDED|90.0|94.36|124.19|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||124.19|94.36|
73890314|NCT02157883|147313050|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|44.33|||||TWO_SIDED|90.0|39.94|49.21|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||49.21|39.94|
73890315|NCT02157883|147313051|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|49.02|||||TWO_SIDED|90.0|43.7|54.99|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||54.99|43.70|
73890316|NCT00357903|147313075|SUPERIORITY_OR_OTHER||Standardized incidence rate|0.0||||||95.0|0.0|53.87||||||||53.87|0.00|
73890317|NCT00357903|147313075|SUPERIORITY_OR_OTHER||Standardized incidence rate|1.3||||||95.0|0.97|1.71||||||||1.71|0.97|
73890318|NCT00606593|147313077|SUPERIORITY_OR_OTHER||Least square means treatment effect|-10.4||||0.0018|TWO_SIDED|95.0|-17.0|-3.9|||Linear model|||||-3.9|-17.0|0.0018
73890319|NCT00606593|147313077|SUPERIORITY_OR_OTHER||Least square means treatment effect|-19.2|||<|0.0001|TWO_SIDED|95.0|-25.7|-12.6|||Linear model|||||-12.6|-25.7|<0.0001
73890320|NCT00606593|147313077|SUPERIORITY_OR_OTHER||Least square means treatment effect|-31.4|||<|0.0001|TWO_SIDED|95.0|-38.0|-24.9|||Linear model|||||-24.9|-38.0|<0.0001
73890321|NCT00606593|147313077|SUPERIORITY_OR_OTHER||Least square means treatment effect|-46.5|||<|0.0001|TWO_SIDED|95.0|-53.3|-39.9|||Linear model|||||-39.9|-53.3|<0.0001
73890322|NCT00606593|147313078|SUPERIORITY_OR_OTHER||Least square means treatment effect|14.3|||<|0.0001|TWO_SIDED|95.0|7.4|21.2|||Linear model|||||21.2|7.4|<0.0001
73890323|NCT00606593|147313078|SUPERIORITY_OR_OTHER||Least square means treatment effect|21.5|||<|0.0001|TWO_SIDED|95.0|14.6|28.4|||Linear model|||||28.4|14.6|<0.0001
73890324|NCT00606593|147313078|SUPERIORITY_OR_OTHER||Least square means treatment effect|34.7|||<|0.0001|TWO_SIDED|95.0|27.8|41.6|||Linear model|||||41.6|27.8|<0.0001
73890325|NCT00606593|147313078|SUPERIORITY_OR_OTHER||Least square means treatment effect|55.1|||<|0.0001|TWO_SIDED|95.0|48.2|62.0|||Linear model|||||62.0|48.2|<0.0001
73890326|NCT02819011|147313093|SUPERIORITY|||||||0.04||||||priori threshold for statistical significance= 0.05|Mixed Models Analysis|||Repeated measures to compare changes in two groups from baseline to 6 months||||0.040
73890327|NCT02819011|147313094|SUPERIORITY|||||||0.005||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months||||0.005
73890328|NCT02819011|147313095|SUPERIORITY|||||||0.019||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months||||0.019
73890329|NCT02819011|147313097|SUPERIORITY|||||||0.572||||||priori threshold for statistical significance = 0.05|Generalized Estimating Equations|||Repeated measures to compare the changes of both groups from pre-intervention to post-intervention year.||||0.572
73890330|NCT02819011|147313098|SUPERIORITY|||||||0.65||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.650
73890331|NCT02819011|147313099|SUPERIORITY|||||||0.756||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.756
73890332|NCT02819011|147313102|SUPERIORITY|||||||0.769||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.769
73890333|NCT02819011|147313103|SUPERIORITY|||||||0.857||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.857
73890334|NCT02819011|147313104|SUPERIORITY|||||||0.829||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.829
73890335|NCT04953728|147313144|SUPERIORITY|||||||0.77306724|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during ST36 100Hz when compared to baseline||||0.77306724
73890336|NCT04953728|147313144|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during ST36 25Hz when compared to baseline||||0.24
73890337|NCT04953728|147313144|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during PC6 100Hz when compared to baseline||||0.45
73890338|NCT04953728|147313144|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during PC6 25Hz when compared to baseline||||0.13
73890339|NCT04953728|147313144|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during Sham when compared to baseline||||0.14
73890340|NCT04953728|147313145|SUPERIORITY|||||||0.81019363|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to ST36 25Hz||||0.81019363
73890341|NCT04953728|147313145|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to PC6 100Hz||||0.18
73890342|NCT04953728|147313145|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to PC6 25Hz||||0.21
73890343|NCT04953728|147313145|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to Sham||||0.58
73890344|NCT04953728|147313145|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to PC6 100Hz||||0.18
73890345|NCT04953728|147313145|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to PC6 25Hz||||0.18
73890346|NCT04953728|147313145|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to sham||||0.78
73890347|NCT04953728|147313145|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 100Hz when compared to PC6 25Hz||||0.89
73890348|NCT04953728|147313145|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 100Hz when compared to sham||||0.05
73890349|NCT04953728|147313145|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 25Hz when compared to sham||||0.07
73890350|NCT04953728|147313146|SUPERIORITY|||||||0.00046998|||||||t-test, 2 sided|||ST36 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.00046998
73890351|NCT04953728|147313146|SUPERIORITY|||||||0.74369428|||||||t-test, 2 sided|||ST36 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.74369428
73890352|NCT04953728|147313146|SUPERIORITY|||||||0.09854383|||||||t-test, 2 sided|||PC6 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.09854383
73890353|NCT04953728|147313146|SUPERIORITY|||||||0.24872746|||||||t-test, 2 sided|||PC6 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.24872746
73890354|NCT04953728|147313146|SUPERIORITY|||||||0.04828889|||||||t-test, 2 sided|||Sham: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.04828889
73890355|NCT04953728|147313147|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||ST36 100Hz compared to ST36 25Hz||||0.02
73890356|NCT04953728|147313147|SUPERIORITY|||||||0.11|||||||t-test, 1 sided|||ST36 100Hz compared to PC6 100Hz||||0.11
73890357|NCT04953728|147313147|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||ST36 100Hz compared to PC6 25Hz||||0.01
73890358|NCT04953728|147313147|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|||ST36 100Hz compared to Sham||||0.04
73890359|NCT04953728|147313147|SUPERIORITY|||||||0.11|||||||t-test, 1 sided|||ST36 25Hz compared to PC6 100Hz||||0.11
73890360|NCT04953728|147313147|SUPERIORITY|||||||0.23|||||||t-test, 1 sided|||ST36 25Hz compared to PC6 25Hz||||0.23
73890361|NCT04953728|147313147|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||ST36 25Hz compared to Sham||||0.17
73890362|NCT04953728|147313147|SUPERIORITY|||||||0.15|||||||t-test, 1 sided|||PC6 100Hz compared to PC6 25Hz||||0.15
73890363|NCT04953728|147313147|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||PC6 100Hz compared to Sham||||0.43
73890364|NCT04953728|147313147|SUPERIORITY|||||||0.19|||||||t-test, 1 sided|||PC6 25Hz compared to Sham||||0.19
73890365|NCT04953728|147313148|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during ST36 100Hz when compared to baseline||||0.87
73890366|NCT04953728|147313148|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during ST36 25Hz when compared to baseline||||0.13
73890367|NCT04953728|147313148|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during PC6 100Hz when compared to baseline||||0.17
73890368|NCT04953728|147313148|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during PC6 25Hz when compared to baseline||||0.88
73890369|NCT04953728|147313148|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during sham when compared to baseline||||0.14
73890370|NCT04953728|147313149|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during ST36 100Hz when compared to baseline||||0.007
73890371|NCT04953728|147313149|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during ST36 25Hz when compared to baseline||||0.83
73890372|NCT04953728|147313149|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during PC6 100Hz when compared to baseline||||0.87
73890373|NCT04953728|147313149|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during PC6 25Hz when compared to baseline||||0.004
73890374|NCT04953728|147313149|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during sham when compared to baseline||||0.056
73890375|NCT02653417|147313172|SUPERIORITY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|||||||||Regimen 1 = 5 mg vs Regimen 4 = placebo||||
73890376|NCT02653417|147313172|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|||||||||Regimen 2 = 10 mg vs Regimen 4 = placebo||||
73890377|NCT02653417|147313172|SUPERIORITY||Mean Difference (Final Values)|0.46|||||TWO_SIDED|||||||||Regimen 3 = 20 mg vs Regimen 4 = placebo||||
73890378|NCT01106690|147313178|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.095|<|0.001|TWO_SIDED|95.0|-0.811|-0.437|||ANCOVA|||||-0.437|-0.811|<0.001
73890379|NCT01106690|147313178|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.951|-0.575|||ANCOVA|||||-0.575|-0.951|<0.001
73890380|NCT01106690|147313179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.007||95.0|1.26|4.57|||Regression, Logistic|||||4.57|1.26|0.007
73890381|NCT01106690|147313179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.38|||<|0.001|TWO_SIDED|95.0|2.73|10.6|||Regression, Logistic|||||10.60|2.73|<0.001
73890382|NCT01106690|147313180|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-29.4|STANDARD_ERROR_OF_MEAN|3.857|<|0.001|TWO_SIDED|95.0|-36.96|-21.78|||ANCOVA|||||-21.78|-36.96|<0.001
73890383|NCT01106690|147313180|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-35.7|STANDARD_ERROR_OF_MEAN|3.861|<|0.001|TWO_SIDED|95.0|-43.3|-28.11|||ANCOVA|||||-28.11|-43.30|<0.001
73890384|NCT01106690|147313181|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|14.28|STANDARD_ERROR_OF_MEAN|2.521|<|0.001|TWO_SIDED|95.0|9.315|19.236|||ANCOVA|||||19.236|9.315|<0.001
73890385|NCT01106690|147313181|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|17.23|STANDARD_ERROR_OF_MEAN|2.509|<|0.001|TWO_SIDED|95.0|12.293|22.166|||ANCOVA|||||22.166|12.293|<0.001
73890386|NCT01106690|147313182|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.6|-1.8|||ANCOVA|||||-1.8|-3.6|<0.001
73890387|NCT01106690|147313182|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-4.6|-2.8|||ANCOVA|||||-2.8|-4.6|<0.001
73890388|NCT01106690|147313183|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.07|STANDARD_ERROR_OF_MEAN|1.43||0.005|TWO_SIDED|95.0|-6.879|-1.251|||ANCOVA|||||-1.251|-6.879|0.005
73890389|NCT01106690|147313183|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.46|STANDARD_ERROR_OF_MEAN|1.433||0.016|TWO_SIDED|95.0|-6.281|-0.643|||ANCOVA|||||-0.643|-6.281|0.016
73890390|NCT01106690|147313184|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|5.7||0.034|TWO_SIDED|95.0|-12.1|-0.9|||ANCOVA|||||-0.9|-12.1|0.034
73890391|NCT01106690|147313184|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|5.7||0.003|TWO_SIDED|95.0|-28.1|-5.8|||ANCOVA|||||-5.8|-28.1|0.003
73890392|NCT01106690|147313185|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|1.9||0.01|TWO_SIDED|95.0|1.2|8.5|||ANCOVA|||||8.5|1.2|0.010
73890393|NCT01106690|147313185|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|2.8|10.2|||ANCOVA|||||10.2|2.8|<0.001
73890394|NCT04614974|147313188|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
73890395|NCT04614974|147313189|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
73890396|NCT04614974|147313190|OTHER|||||||0.5|||||||McNemar|||Noisy breathing pre/post||||0.5
73890397|NCT04614974|147313190|OTHER|||||||0.01|||||||McNemar|||Noisy breathing pre/post||||0.01
73890398|NCT04614974|147313190|OTHER|||||||0.2|||||||McNemar|||Stridor pre/post||||0.2
73890399|NCT04614974|147313190|SUPERIORITY|||||||0.02|||||||McNemar|||Stridor pre/post||||0.02
73890400|NCT04614974|147313190|OTHER|||||||0.5|||||||McNemar|||Chest wall retractions pre/post||||0.5
73890401|NCT04614974|147313190|OTHER|||||||1|||||||McNemar|||Chest wall retractions pre/post||||1.0
73890402|NCT04614974|147313190|OTHER|||||||1|||||||McNemar|||Apnea pre/post||||1.0
73890403|NCT04614974|147313191|OTHER|||||||0.5|||||||McNemar|||Emesis pre/post||||0.5
73890404|NCT04614974|147313191|OTHER|||||||0.07|||||||McNemar|||Emesis pre/post||||0.07
73890405|NCT04614974|147313191|SUPERIORITY|||||||0.06|||||||McNemar|||Choking pre/post||||0.06
73890406|NCT04614974|147313191|OTHER|||||||1|||||||McNemar|||Choking pre/post||||1.0
73890407|NCT04614974|147313191|OTHER|||||||0.02|||||||McNemar|||Coughing pre/post||||0.02
73890408|NCT04614974|147313191|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Coughing pre/post||||1.0
73890409|NCT04614974|147313191|OTHER|||||||1|||||||McNemar|||Gagging pre/post||||1.0
73890410|NCT04614974|147313192|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
73890411|NCT04614974|147313193|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73890412|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|2.27|||||TWO_SIDED|95.0|-3.96|8.49||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||8.49|-3.96|
73890413|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|0.198|||||TWO_SIDED|95.0|-3.19|3.59||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.59|-3.19|
73890414|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|1.55|||||TWO_SIDED|95.0|-2.25|5.35||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.35|-2.25|
73890415|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|20.0|||||TWO_SIDED|95.0|13.7|26.2||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||26.2|13.7|
73890416|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|6.19|||||TWO_SIDED|95.0|2.8|9.58||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.58|2.80|
73890417|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|11.7|||||TWO_SIDED|95.0|7.87|15.5||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||15.5|7.87|
73890418|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|-13.9|||||TWO_SIDED|95.0|-18.9|-8.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-8.80|-18.9|
73890419|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|-4.62|||||TWO_SIDED|95.0|-7.67|-1.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-1.56|-7.67|
73890420|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|-8.43|||||TWO_SIDED|95.0|-11.5|-5.33||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.33|-11.5|
73890421|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|7.8|||||TWO_SIDED|95.0|2.72|12.9||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||12.9|2.72|
73890422|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|4.38|||||TWO_SIDED|95.0|1.3|7.46||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||7.46|1.30|
73890423|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|5.06|||||TWO_SIDED|95.0|1.93|8.18||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.18|1.93|
73890424|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|0.905|||||TWO_SIDED|95.0|-5.49|7.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||7.30|-5.49|
73890425|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|-2.71|||||TWO_SIDED|95.0|-6.96|1.54||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.54|-6.96|
73890426|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|1.66|||||TWO_SIDED|95.0|-2.85|6.16||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.16|-2.85|
73890427|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|17.5|||||TWO_SIDED|95.0|11.2|23.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||23.8|11.2|
73890428|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|6.51|||||TWO_SIDED|95.0|2.32|10.7||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||10.7|2.32|
73890429|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|14.2|||||TWO_SIDED|95.0|9.75|18.7||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||18.7|9.75|
73890430|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|||||TWO_SIDED|95.0|-14.6|-5.34||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.34|-14.6|
73890431|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|-3.46|||||TWO_SIDED|95.0|-7.22|0.297||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.297|-7.22|
73890432|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|-8.16|||||TWO_SIDED|95.0|-11.6|-4.71||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-4.71|-11.6|
73890433|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|12.1|||||TWO_SIDED|95.0|7.39|16.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||16.8|7.39|
73890434|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|6.7|||||TWO_SIDED|95.0|2.91|10.5||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.5|2.91|
73890435|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|10.3|||||TWO_SIDED|95.0|6.88|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.8|6.88|
73890436|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|-1.06|||||TWO_SIDED|95.0|-7.41|5.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.30|-7.41|
73890437|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|2.2|||||TWO_SIDED|95.0|-2.15|6.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.56|-2.15|
73890438|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||||TWO_SIDED|95.0|-3.23|5.47||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.47|-3.23|
73890439|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|19.4|||||TWO_SIDED|95.0|13.2|25.6||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||25.6|13.2|
73890440|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|9.04|||||TWO_SIDED|95.0|4.78|13.3||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||13.3|4.78|
73890441|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|14.7|||||TWO_SIDED|95.0|10.4|18.9||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||18.9|10.4|
73890442|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|-10.6|||||TWO_SIDED|95.0|-15.6|-5.52||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.52|-15.6|
73890443|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|-4.25|||||TWO_SIDED|95.0|-9.26|0.764||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.764|-9.26|
73890444|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|-8.76|||||TWO_SIDED|95.0|-12.6|-4.87||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-4.87|-12.6|
73890445|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|12.3|||||TWO_SIDED|95.0|7.17|17.4||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||17.4|7.17|
73890446|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|5.95|||||TWO_SIDED|95.0|0.917|11.0||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||11.0|0.917|
73890447|NCT01263197|147313233|SUPERIORITY_OR_OTHER||LS mean difference|9.9|||||TWO_SIDED|95.0|5.98|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.8|5.98|
73890448|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|1.62|||||TWO_SIDED|95.0|-1.81|5.06||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.06|-1.81|
73890449|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|2.73|||||TWO_SIDED|95.0|-1.38|6.85||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.85|-1.38|
73890450|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|2.67|||||TWO_SIDED|95.0|-0.209|5.56||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.56|-0.209|
73890451|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|0.541|||||TWO_SIDED|95.0|-2.94|4.02||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.02|-2.94|
73890452|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|5.26|||||TWO_SIDED|95.0|1.09|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.43|1.09|
73890453|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||||TWO_SIDED|95.0|-0.322|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.52|-0.322|
73890454|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-6.46|||||TWO_SIDED|95.0|-11.5|-1.41||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-1.41|-11.5|
73890455|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|0.171|||||TWO_SIDED|95.0|-5.21|5.56||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.56|-5.21|
73890456|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-3.09|||||TWO_SIDED|95.0|-6.73|0.557||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.557|-6.73|
73890457|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||||TWO_SIDED|95.0|-3.61|6.53||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||6.53|-3.61|
73890458|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|11.4|||||TWO_SIDED|95.0|5.99|16.8||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||16.8|5.99|
73890459|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|7.15|||||TWO_SIDED|95.0|3.49|10.8||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.8|3.49|
73890460|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|0.0309|||||TWO_SIDED|95.0|-5.28|5.34||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.34|-5.28|
73890461|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-1.17|||||TWO_SIDED|95.0|-5.93|3.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.59|-5.93|
73890462|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-0.333|||||TWO_SIDED|95.0|-4.35|3.68||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.68|-4.35|
73890463|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-2.11|||||TWO_SIDED|95.0|-7.42|3.2||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||3.20|-7.42|
73890464|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|4.36|||||TWO_SIDED|95.0|-0.404|9.12||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.12|-0.404|
73890465|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-0.119|||||TWO_SIDED|95.0|-4.14|3.9||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||3.90|-4.14|
73890466|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-4.16|||||TWO_SIDED|95.0|-9.69|1.37||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.37|-9.69|
73890467|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-4.76|||||TWO_SIDED|95.0|-10.2|0.718||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.718|-10.2|
73890468|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-4.2|||||TWO_SIDED|95.0|-8.71|0.32||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.320|-8.71|
73890469|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|3.2|||||TWO_SIDED|95.0|-2.34|8.74||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.74|-2.34|
73890470|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|3.95|||||TWO_SIDED|95.0|-1.54|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.43|-1.54|
73890471|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|4.84|||||TWO_SIDED|95.0|0.319|9.37||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.37|0.319|
73890472|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|2.34|||||TWO_SIDED|95.0|-3.44|8.12||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||8.12|-3.44|
73890473|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|1.89|||||TWO_SIDED|95.0|-3.22|7.0||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||7.00|-3.22|
73890474|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|1.83|||||TWO_SIDED|95.0|-1.85|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.52|-1.85|
73890475|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|0.327|||||TWO_SIDED|95.0|-5.45|6.1||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.10|-5.45|
73890476|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|3.18|||||TWO_SIDED|95.0|-1.93|8.29||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||8.29|-1.93|
73890477|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|2.12|||||TWO_SIDED|95.0|-1.56|5.81||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.81|-1.56|
73890478|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-1.6|||||TWO_SIDED|95.0|-6.79|3.59||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.59|-6.79|
73890479|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-0.163|||||TWO_SIDED|95.0|-5.0|4.68||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||4.68|-5.00|
73890480|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|-0.829|||||TWO_SIDED|95.0|-5.2|3.54||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.54|-5.20|
73890481|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|1.95|||||TWO_SIDED|95.0|-3.27|7.17||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||7.17|-3.27|
73890482|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|3.71|||||TWO_SIDED|95.0|-1.17|8.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.59|-1.17|
73890483|NCT01263197|147313234|SUPERIORITY_OR_OTHER||LS mean difference|4.28|||||TWO_SIDED|95.0|-0.103|8.67||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.67|-0.103|
73890484|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|||||TWO_SIDED|95.0|-3.9|1.44||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.44|-3.90|
73890485|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|1.05|||||TWO_SIDED|95.0|-1.91|4.02||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||4.02|-1.91|
73890486|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-0.199|||||TWO_SIDED|95.0|-2.58|2.18||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.18|-2.58|
73890487|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|1.37|||||TWO_SIDED|95.0|-1.34|4.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.07|-1.34|
73890488|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||||TWO_SIDED|95.0|0.674|6.69||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.69|0.674|
73890489|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|2.4|||||TWO_SIDED|95.0|-0.0178|4.81||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.81|-0.0178|
73890490|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-4.22|||||TWO_SIDED|95.0|-7.83|-0.619||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-0.619|-7.83|
73890491|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|0.335|||||TWO_SIDED|95.0|-4.45|5.12||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.12|-4.45|
73890492|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-1.92|||||TWO_SIDED|95.0|-4.81|0.969||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.969|-4.81|
73890493|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|2.47|||||TWO_SIDED|95.0|-1.15|6.1||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||6.10|-1.15|
73890494|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|9.12|||||TWO_SIDED|95.0|4.3|13.9||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.9|4.30|
73890495|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|6.03|||||TWO_SIDED|95.0|3.12|8.94||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.94|3.12|
73890496|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-0.913|||||TWO_SIDED|95.0|-4.65|2.82||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.82|-4.65|
73890497|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-0.444|||||TWO_SIDED|95.0|-4.33|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.44|-4.33|
73890498|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|0.378|||||TWO_SIDED|95.0|-2.2|2.95||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.95|-2.20|
73890499|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|0.878|||||TWO_SIDED|95.0|-2.86|4.62||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.62|-2.86|
73890500|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|2.92|||||TWO_SIDED|95.0|-0.966|6.8||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.80|-0.966|
73890501|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|2.94|||||TWO_SIDED|95.0|0.366|5.52||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.52|0.366|
73890502|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-2.88|||||TWO_SIDED|95.0|-6.84|1.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.07|-6.84|
73890503|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-0.975|||||TWO_SIDED|95.0|-5.39|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.44|-5.39|
73890504|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-1.82|||||TWO_SIDED|95.0|-5.3|1.66||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.66|-5.30|
73890505|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|5.6|||||TWO_SIDED|95.0|1.63|9.56||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.56|1.63|
73890506|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|7.82|||||TWO_SIDED|95.0|3.39|12.3||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||12.3|3.39|
73890507|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|6.6|||||TWO_SIDED|95.0|3.11|10.1||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.1|3.11|
73890508|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|0.847|||||TWO_SIDED|95.0|-3.23|4.92||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||4.92|-3.23|
73890509|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-3.48|||||TWO_SIDED|95.0|-8.17|1.21||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.21|-8.17|
73890510|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-0.372|||||TWO_SIDED|95.0|-2.88|2.14||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.14|-2.88|
73890511|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|-2.17|5.98||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.98|-2.17|
73890512|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-3.62|5.76||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.76|-3.62|
73890513|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|3.03|||||TWO_SIDED|95.0|0.522|5.55||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.55|0.522|
73890514|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|0.737|||||TWO_SIDED|95.0|-3.9|5.38||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.38|-3.90|
73890515|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-1.95|||||TWO_SIDED|95.0|-6.36|2.47||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||2.47|-6.36|
73890516|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|-1.17|||||TWO_SIDED|95.0|-4.79|2.45||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||2.45|-4.79|
73890517|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|7.25|||||TWO_SIDED|95.0|2.59|11.9||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||11.9|2.59|
73890518|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|5.58|||||TWO_SIDED|95.0|1.13|10.0||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.0|1.13|
73890519|NCT01263197|147313235|SUPERIORITY_OR_OTHER||LS mean difference|5.53|||||TWO_SIDED|95.0|1.89|9.16||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.16|1.89|
73890520|NCT00643162|147313265|OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|6.15||0.68|TWO_SIDED||||||t-test, 2 sided|||||||.68
73890521|NCT02691507|147313268|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890522|NCT02691507|147313268|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
73890523|NCT02691507|147313268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.795||0.616|TWO_SIDED|95.0|-1.196|1.998||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.998|-1.196|0.616
73890524|NCT02691507|147313269|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890525|NCT02691507|147313269|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890526|NCT02691507|147313269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|0.803||0.297|TWO_SIDED|95.0|-0.767|2.46||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.460|-0.767|0.297
73890527|NCT02691507|147313270|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890528|NCT02691507|147313270|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890529|NCT02691507|147313270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.846||0.394|TWO_SIDED|95.0|-0.973|2.426||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.426|-0.973|0.394
73890530|NCT02691507|147313271|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890531|NCT02691507|147313271|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890532|NCT02691507|147313271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.708||0.69|TWO_SIDED|95.0|-1.14|1.709||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.709|-1.140|0.690
73890533|NCT02691507|147313272|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890534|NCT02691507|147313272|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890535|NCT02691507|147313272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.735||0.914|TWO_SIDED|95.0|-1.556|1.397||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.397|-1.556|0.914
73890536|NCT02691507|147313273|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890537|NCT02691507|147313273|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890538|NCT02691507|147313273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.774||0.757|TWO_SIDED|95.0|-1.796|1.314||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.314|-1.796|0.757
73890539|NCT02691507|147313274|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890540|NCT02691507|147313274|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890541|NCT02691507|147313274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.798||0.556|TWO_SIDED|95.0|-2.075|1.129||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.129|-2.075|0.556
73890542|NCT02691507|147313275|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890543|NCT02691507|147313275|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890544|NCT02691507|147313275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.772||0.106|TWO_SIDED|95.0|-2.824|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.278|-2.824|0.106
73890545|NCT02691507|147313276|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890546|NCT02691507|147313276|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890547|NCT02691507|147313276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.83|STANDARD_ERROR_OF_MEAN|6.681|<|0.001|TWO_SIDED|95.0|13.407|40.247||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||40.247|13.407|<0.001
73890548|NCT02691507|147313277|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890549|NCT02691507|147313277|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
73890550|NCT02691507|147313277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.33|STANDARD_ERROR_OF_MEAN|3.996|<|0.001|TWO_SIDED|95.0|11.301|27.352||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||27.352|11.301|<0.001
73890551|NCT02691507|147313278|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890552|NCT02691507|147313278|SUPERIORITY_OR_OTHER|||||||0.009||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.009
73890553|NCT02691507|147313278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.01|STANDARD_ERROR_OF_MEAN|4.072|<|0.001|TWO_SIDED|95.0|7.829|24.187||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||24.187|7.829|<0.001
73890554|NCT02691507|147313279|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890555|NCT02691507|147313279|SUPERIORITY_OR_OTHER|||||||0.003||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.003
73890556|NCT02691507|147313279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.25|STANDARD_ERROR_OF_MEAN|3.764|<|0.001|TWO_SIDED|95.0|5.684|20.82||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||20.820|5.684|<0.001
73890557|NCT02691507|147313280|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890558|NCT02691507|147313280|SUPERIORITY_OR_OTHER|||||||0.049||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.049
73890559|NCT02691507|147313280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.08|STANDARD_ERROR_OF_MEAN|4.138||0.001|TWO_SIDED|95.0|5.766|22.387||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||22.387|5.766|0.001
73890560|NCT02691507|147313281|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890561|NCT02691507|147313281|SUPERIORITY_OR_OTHER|||||||0.024||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.024
73890562|NCT02691507|147313281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.26|STANDARD_ERROR_OF_MEAN|4.679||0.004|TWO_SIDED|95.0|4.862|23.66||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||23.660|4.862|0.004
73890563|NCT02691507|147313282|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890564|NCT02691507|147313282|SUPERIORITY_OR_OTHER|||||||0.015||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.015
73890565|NCT02691507|147313282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.77|STANDARD_ERROR_OF_MEAN|4.222||0.004|TWO_SIDED|95.0|4.291|21.252||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.252|4.291|0.004
73890566|NCT02691507|147313283|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
73890567|NCT02691507|147313283|SUPERIORITY_OR_OTHER|||||||0.034||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.034
73890568|NCT02691507|147313283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.71|STANDARD_ERROR_OF_MEAN|5.925||0.037|TWO_SIDED|95.0|0.805|24.621||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||24.621|0.805|0.037
73890569|NCT00541385|147313331|OTHER|"Analysis of the PCR-corrected ACPR response rate on Day 28 for the PA group. Null hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is ≤90%.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is \>90%."|||||<|0.0001||||||The threshold for significance was ≤0.025.|Exact binomial test|||||||<0.0001
73890570|NCT00541385|147313331|NON_INFERIORITY|The secondary efficacy analysis tested the non-inferiority of PA compared to the AL group with regard to the PCR-corrected ACPR response rate on Day 28 using a 2-sided 95% confidence interval (Newcombe Wilson score method without continuity correction) and a 10% non-inferiority margin for the EE population. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval for the difference in 28-day PCR-corrected ACPR was not lower than 10%.|ACPR percent difference|-1.2||||0.3728|TWO_SIDED|95.0|-3.6|2.1||If non-inferiority of PA was demonstrated, the p-value associated with a superiority test was calculated based on a 2-sided Chi-Square test. If the calculated p-value was \<0.05, then the superiority of PA over AL was statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate for the AL group.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate for the AL group."||2.1|-3.6|0.3728
73890571|NCT00888940|147313368|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
73890572|NCT02141204|147313383|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% confidence interval (CI) for the ratio of anti-RV IgA antibody GMCs between HRV Liq Group over the HRV Lyo Group should be greater than or equal to (≥) 0.5.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.65|1.34|||ANCOVA|95% CI for the adjusted GMC ratio and the logarithm of baseline concentration were used as fixed effects in this ANCOVA model.||Anti-RV IgA GMCs (non-inferiority): Non-inferiority comparison between GSK Biologicals' HRV liquid vaccine (HRV Liq Group) and GSK Biologicals' HRV lyophilized vaccine (HRV Lyo Group) in terms of geometric mean concentrations (GMCs) for anti-RV antibodies, one month after the administration of the second dose of study vaccine.||1.34|0.65|
73890573|NCT00607373|147313388|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Fifty-one patients were enrolled to allow for patient withdrawals and potential exclusions from analysis sets.||||<0.001
73890574|NCT00607373|147313389|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
73890575|NCT00607373|147313391|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided|||||||<0.001
73890576|NCT00607373|147313394|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided|||||||<0.001
73890577|NCT00607373|147313396|SUPERIORITY_OR_OTHER|||||||0.013||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.013
73890578|NCT00607373|147313398|SUPERIORITY_OR_OTHER|||||||0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.001
73890579|NCT00607373|147313400|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.009
73890580|NCT00607373|147313402|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.001
73890581|NCT00607373|147313404|SUPERIORITY_OR_OTHER|||||||0.328||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.328
73890582|NCT00607373|147313406|SUPERIORITY_OR_OTHER|||||||0.035||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.035
73890583|NCT04546672|147313409|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.58|TWO_SIDED|95.0|-31.1|55.4|||t-test, 2 sided|||||55.4|-31.1|0.58
73890584|NCT04546672|147313410|SUPERIORITY||Mean Difference (Final Values)|12.3|||<|0.001|TWO_SIDED|95.0|9.2|15.4|||t-test, 2 sided|||||15.4|9.2|<0.001
73890585|NCT04546672|147313411|SUPERIORITY||Odds Ratio (OR)|2.3||||0.087|TWO_SIDED|95.0|0.9|6.2|||Fisher Exact|||||6.2|0.9|0.087
73890586|NCT04546672|147313412|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.48|TWO_SIDED|95.0|-26.4|12.6|||t-test, 2 sided|||||12.6|-26.4|0.48
73890587|NCT04546672|147313413|SUPERIORITY||Mean Difference (Final Values)|16.7||||0.02|TWO_SIDED|95.0|2.3|31.1|||t-test, 2 sided|||||31.1|2.3|0.02
73890588|NCT04546672|147313414|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.27|TWO_SIDED|95.0|-2.2|8.3|||t-test, 2 sided|||||8.3|-2.2|0.27
73890589|NCT01724346|147313417|SUPERIORITY||Hazard Ratio (HR)|0.155|||<|0.0001|TWO_SIDED|95.0|0.11|0.22||P-value is from stratified log-rank test.|Log Rank|||||0.220|0.110|< 0.0001
73890590|NCT01724346|147313420|SUPERIORITY||Hazard Ratio (HR)|0.087|||<|0.0001|TWO_SIDED|95.0|0.054|0.141||P value is from stratified log-rank test.|Log Rank|||||0.141|0.054|< 0.0001
73890591|NCT01724346|147313421|SUPERIORITY||Rate ratio|2.496|||<|0.0001|TWO_SIDED|95.0|1.99|3.131||Rate ratio and p-value are based on Cochran-Mantel-Haenszel chi-square test stratified by Eastern Cooperative Oncology Group (ECOG; 0-1 vs 2) and Rai stage (0/I/II vs III/IV) at baseline.|Cochran-Mantel-Haenszel|||||3.131|1.990|< 0.0001
73890592|NCT00298558|147313433|SUPERIORITY_OR_OTHER||Effect Size|0.06||||0.43|TWO_SIDED|99.0|-0.14|0.27|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.27|-0.14|0.43
73890593|NCT00298558|147313433|SUPERIORITY_OR_OTHER||Effect Size|-0.11||||0.17|TWO_SIDED|99.0|-0.31|0.1|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.10|-0.31|0.17
73890594|NCT00298558|147313433|SUPERIORITY_OR_OTHER||Effect Size|-0.05||||0.52|TWO_SIDED|99.0|-0.25|0.15|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.15|-0.25|0.52
73890595|NCT00298558|147313436|SUPERIORITY_OR_OTHER||Effect Size|-0.02||||0.69|TWO_SIDED|99.0|-0.17|0.12|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.12|-0.17|0.69
73890596|NCT00298558|147313436|SUPERIORITY_OR_OTHER||Effect Size|0.23|||<|0.01|TWO_SIDED|99.0|0.09|0.38|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.38|0.09|<0.01
73890597|NCT00298558|147313436|SUPERIORITY_OR_OTHER||Effect Size|-0.06||||0.27|TWO_SIDED|99.0|-0.2|0.08|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.08|-0.20|0.27
73890598|NCT00298558|147313438|SUPERIORITY_OR_OTHER||Effect Size|-0.07||||0.45|TWO_SIDED|99.0|-0.29|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.16|-0.29|0.45
73890599|NCT00298558|147313438|SUPERIORITY_OR_OTHER||Effect Size|0.005||||0.95|TWO_SIDED|99.0|-0.22|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.23|-0.22|0.95
73890600|NCT00298558|147313438|SUPERIORITY_OR_OTHER||Effect Size|0.66|||<|0.01|TWO_SIDED|99.0|0.43|0.88|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.88|0.43|<0.01
73890601|NCT00298558|147313439|SUPERIORITY_OR_OTHER||Effect Size|0.48|||<|0.01|TWO_SIDED|99.0|0.12|0.84|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.84|0.12|<0.01
73890602|NCT00298558|147313439|SUPERIORITY_OR_OTHER||Effect Size|0.38|||<|0.01|TWO_SIDED|99.0|0.02|0.74|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.74|0.02|<0.01
73890603|NCT00298558|147313439|SUPERIORITY_OR_OTHER||Effect Size|0.36|||<|0.01|TWO_SIDED|99.0|0.01|0.72|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.72|0.01|<0.01
73890604|NCT00298558|147313440|SUPERIORITY_OR_OTHER||Effect Size|0.004||||0.97|TWO_SIDED|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.24|-0.23|0.97
73890605|NCT00298558|147313440|SUPERIORITY_OR_OTHER||Effect Size|-0.02||||0.86|TWO_SIDED|99.0|-0.25|0.22|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.22|-0.25|0.86
73890606|NCT00298558|147313440|SUPERIORITY_OR_OTHER||Effect Size|0.008||||0.93|TWO_SIDED|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.24|-0.23|0.93
73890607|NCT00298558|147313441|SUPERIORITY_OR_OTHER||Effect Size|0.02||||0.78|TWO_SIDED|99.0|-0.19|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.23|-0.19|0.78
73890608|NCT00298558|147313441|SUPERIORITY_OR_OTHER||Effect Size|-0.004||||0.96|TWO_SIDED|99.0|-0.21|0.21|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.21|-0.21|0.96
73890609|NCT00298558|147313441|SUPERIORITY_OR_OTHER||Effect Size|-0.05||||0.56|TWO_SIDED|99.0|-0.26|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.16|-0.26|0.56
73890610|NCT02876601|147313442|SUPERIORITY|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||||||0.408
73890611|NCT02876601|147313443|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||||||0.148
73890612|NCT02876601|147313444|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
73890613|NCT02876601|147313445|SUPERIORITY|||||||0.642|||||||Wilcoxon (Mann-Whitney)|||||||0.642
73890614|NCT02876601|147313446|SUPERIORITY|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
73890615|NCT02876601|147313447|SUPERIORITY|||||||0.326|||||||Wilcoxon (Mann-Whitney)|||||||0.326
73890616|NCT02876601|147313448|SUPERIORITY|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||||||0.796
73890617|NCT02876601|147313449|SUPERIORITY|||||||0.918|||||||Wilcoxon (Mann-Whitney)|||||||0.918
73890618|NCT02876601|147313450|SUPERIORITY|||||||0.877|||||||Wilcoxon (Mann-Whitney)|||||||0.877
73890619|NCT02876601|147313451|SUPERIORITY|||||||0.423|||||||Wilcoxon (Mann-Whitney)|||||||0.423
73890620|NCT02876601|147313452|SUPERIORITY|||||||0.938|||||||Wilcoxon (Mann-Whitney)|||||||0.938
73890621|NCT00256997|147313471|SUPERIORITY_OR_OTHER|||||||0.5498||||||P-value was calculated by Cox proportional hazard model stratified for positive and negative symptom scale.|Cox proportional hazard model|||||||0.5498
73890622|NCT00354432|147313481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3455|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|A mixed effects repeated measures analysis of variance was used with the baseline means constrained to be equal in the four groups.||The null hypothesis was that there was no difference in the hot flash severity score at 12 weeks.||||.3455
73890623|NCT00354432|147313482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2081|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|||Null hypothesis was that there was no difference in quality of life between the four groups at 12 weeks.||||0.2081
73890624|NCT01322945|147313491|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
73890625|NCT05232682|147313498|OTHER||F-test|2.41||||0.1183|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.1183
73890626|NCT05232682|147313499|OTHER||F-test|0.07||||0.9308|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.9308
73890627|NCT05232682|147313500|OTHER||F-test|2.1||||0.1517|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.1517
73890628|NCT05232682|147313501|OTHER||F-test|0.14||||0.8747|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.8747
73890629|NCT05232682|147313502|OTHER||F-test|1.19||||0.3269|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.3269
73890630|NCT05232682|147313503|OTHER||F-test|1.14||||0.3411|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.3411
73890631|NCT01136980|147313515|SUPERIORITY||||||<|0.028|||||||Chi-squared|||||||<0.028
73890632|NCT00880919|147313517|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|||Mean changes were calculated using each groups linear and quadratic effects||||.015
73890633|NCT02015637|147313529|NON_INFERIORITY|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rate|-5.9|||||TWO_SIDED|95.0|-13.18|1.36||||||||1.36|-13.18|
73890634|NCT02015637|147313530|NON_INFERIORITY|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rates|-9.9|||||TWO_SIDED|95.0|-16.03|-3.87||||||||-3.87|-16.03|
73890635|NCT02223858|147313533|SUPERIORITY|A sample size of 360 patients (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.791|||||||Mixed Models Analysis|All models adjusted for site.||||||0.791
73890636|NCT02223858|147313534|SUPERIORITY|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.88|||||||Mixed Models Analysis|All models adjusted for site.||||||0.880
73890637|NCT02223858|147313535|SUPERIORITY|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscale, and a 80% power.||||||0.901|||||||Mixed Models Analysis|All models adjusted for site.||||||0.901
73890638|NCT02106390|147313546|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|0.89|||||TWO_SIDED|95.0|0.71|1.1|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||"H44/76- The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the H44/76 serogroup B indicator strain,at one month after the fourth vaccination."||1.10|0.71|
73890639|NCT02106390|147313546|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.74|1.45|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||5/99-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the 5/99 serogroup B indicator strain,at one month after the fourth vaccination.||1.45|0.74|
73890640|NCT02106390|147313546|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.01|||||TWO_SIDED|95.0|0.82|1.25|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||NZ98/254-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the NZ98/254 serogroup B indicator strain,at one month after the fourth vaccination.||1.25|0.82|
73890641|NCT02106390|147313546|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.77|1.4|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||M10713-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the M10713 serogroup B indicator strain,at one month after the fourth vaccination.||1.40|0.77|
73890642|NCT02106390|147313547|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|2.48|||||TWO_SIDED|95.0|1.97|3.11|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup A-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for serogroup A at one month after the fourth vaccination.||3.11|1.97|
73890643|NCT02106390|147313547|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.07|||||TWO_SIDED|95.0|0.83|1.38|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup C-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup C at one month after the fourth vaccination.||1.38|0.83|
73890644|NCT02106390|147313547|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.04|1.74|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup W-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup W-135 at one month after the fourth vaccination.||1.74|1.04|
73890645|NCT02106390|147313547|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.05|||||TWO_SIDED|95.0|0.82|1.35|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup Y-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup Y at one month after the fourth vaccination.||1.35|0.82|
73890646|NCT03198507|147313579|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0||||Statistical testing was 2 sided and performed using a significance (alpha) level of 0.05.|t-test, 2 sided|||||||0.0001
73890647|NCT03198507|147313582|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
73890648|NCT00241839|147313590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.27|STANDARD_ERROR_OF_MEAN|2.24||0.059|TWO_SIDED|95.0|-0.17|8.7|||t-test, 2 sided|Satterthwaite correction for possibly unequal variance was made|A positive value of the estimated value would favor the allopurinol arm. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We compared the drop in baseline of diastolic BP for the two treatment groups Allopurinol vs. Placebo by a Satterthwaite corrected t-test.||8.7|-0.17|0.059
73890649|NCT00241839|147313591|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|STANDARD_ERROR_OF_MEAN|1.59||0.47|TWO_SIDED|95.0|-2.0|4.3||Positive numbers indicate a drop. We compared baseline minus value at treatment end for the two treatments.|t-test, 2 sided|Satterthwaite correction was used for potentially unequal variances.|The analysis is limited to those with both baseline and 8-10 week data on this variable.|||4.3|-2.0|0.47
73890650|NCT00241839|147313592|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.76|STANDARD_ERROR_OF_MEAN|2.11||0.002|TWO_SIDED|95.0|-11.0|-2.6|||t-test, 2 sided|Sattherthwaite correction was used|The analysis is limited to those with both baseline and 8-10 week data on this variable. The 24 hour was in the opposite direction of the cuff.|||-2.6|-11.0|0.0020
73890651|NCT00241839|147313593|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.15|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|1.72|2.59|||t-test, 2 sided|Satterthwaite correction was used.|Allopurinol was associated with a significant decrease in uric acid over the treatment period as compared to placebo. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We expected allopurinol to be associated with a decrease in uric acid.||2.59|1.72|<0.001
73890652|NCT02863419|147313602|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.1|||<|0.0001|TWO_SIDED|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin. The non-inferiority margin was 0.4%|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.0|-0.3|<0.0001
73890653|NCT02863419|147313602|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1||||0.0645|TWO_SIDED|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.0|-0.3|0.0645
73890654|NCT02863419|147313602|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.2|<0.0001
73890655|NCT02863419|147313602|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2|||<|0.0001|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-0.3|<0.0001
73890656|NCT02863419|147313602|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2||||0.0056|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-0.3|0.0056
73890657|NCT02863419|147313602|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.2||||0.0001|TWO_SIDED|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.0|-1.4|0.0001
73890658|NCT02863419|147313603|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2||||0.0003|TWO_SIDED|95.0|-1.9|-0.6||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.9|0.0003
73890659|NCT02863419|147313603|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.7|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-3.0|-4.7|<0.0001
73890660|NCT02863419|147313603|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.9|-2.2|<0.0001
73890661|NCT02863419|147313603|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-4.8|-3.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral sema 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-3.2|-4.8|<0.0001
73890662|NCT02863419|147313624|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.17||||0.4915|TWO_SIDED|95.0|0.75|1.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.80|0.75|0.4915
73890663|NCT02863419|147313624|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.48||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.48|0.21|<0.0001
73890664|NCT02863419|147313625|SUPERIORITY|This hypothesis was not controlled for multiplicity|Hazard Ratio (HR)|1.17||||0.6252|TWO_SIDED|95.0|0.62|2.22||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||2.22|0.62|0.6252
73890665|NCT02863419|147313625|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.26|0.09|<0.0001
73890666|NCT01821118|147313679|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.984|STANDARD_ERROR_OF_MEAN|0.112|||TWO_SIDED|90.0|0.82|1.184|||||SE of mean is presented in log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.184|0.820|
73890667|NCT01821118|147313679|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.934|STANDARD_ERROR_OF_MEAN|0.075|||TWO_SIDED|90.0|0.825|1.056|||||SE of mean is presented in log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.056|0.825|
73890668|NCT01821118|147313680|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.852|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|90.0|0.735|0.989|||||SE of mean is presented on log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||0.989|0.735|
73890669|NCT01821118|147313680|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.902|STANDARD_ERROR_OF_MEAN|0.082|||TWO_SIDED|90.0|0.788|1.031|||||SE of mean presented on log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.031|0.788|
73890670|NCT01821118|147313681|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.005|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|90.0|0.933|1.086|||||SE of mean presented on log e scale.|ROI1, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.086|0.933|
73890671|NCT01821118|147313681|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.049|STANDARD_ERROR_OF_MEAN|0.036|||TWO_SIDED|90.0|0.99|1.114|||||SE of mean presented on log e scale.|ROI1, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.114|0.990|
73890672|NCT01821118|147313681|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.998|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|90.0|0.947|1.052|||||SE of mean presented on log e scale.|ROI2, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.052|0.947|
73890673|NCT01821118|147313681|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|90.0|0.96|1.063|||||SE of mean presented on log e scale.|ROI2, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.063|0.960|
73890674|NCT01821118|147313682|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0602|STANDARD_ERROR_OF_MEAN|0.1281|||TWO_SIDED|90.0|-0.1576|0.2781||||||ROI1, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.2781|-0.1576|
73890675|NCT01821118|147313682|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0859|STANDARD_ERROR_OF_MEAN|0.1165|||TWO_SIDED|90.0|-0.2843|0.1124||||||ROI1, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.1124|-0.2843|
73890676|NCT01821118|147313682|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0488|STANDARD_ERROR_OF_MEAN|0.0902|||TWO_SIDED|90.0|-0.2018|0.1042||||||ROI2, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.1042|-0.2018|
73890677|NCT01821118|147313682|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0888|STANDARD_ERROR_OF_MEAN|0.1061|||TWO_SIDED|90.0|-0.2689|0.0914||||||ROI2, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.0914|-0.2689|
73890678|NCT01821118|147313683|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0464|STANDARD_ERROR_OF_MEAN|0.0395|||TWO_SIDED|90.0|-0.0207|0.1136||||||ROI1, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.1136|-0.0207|
73890679|NCT01821118|147313683|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0737|STANDARD_ERROR_OF_MEAN|0.0383|||TWO_SIDED|90.0|0.0084|0.139||||||ROI1, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.1390|0.0084|
73890680|NCT01821118|147313683|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0219|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|90.0|-0.0352|0.079||||||ROI2, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.0790|-0.0352|
73890681|NCT01821118|147313683|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0117|STANDARD_ERROR_OF_MEAN|0.034|||TWO_SIDED|90.0|-0.046|0.0694||||||ROI2, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.0694|-0.0460|
73890682|NCT02284243|147313738|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANCOVA|||||||0.0180
73890683|NCT02284243|147313739|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, and SPID 0-24|ANCOVA|||||||<0.05
73890684|NCT02284243|147313740|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to perceptible and meaningful pain relief|Log Rank|||||||<0.05
73890685|NCT02284243|147313741|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to ≥30% and ≥50% reduction in pain|Cochran-Mantel-Haenszel|Test for general association stratified by site||||||<0.05
73890686|NCT02284243|147313743|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Log Rank|||||||0.0009
73890687|NCT02284243|147313744|SUPERIORITY_OR_OTHER|||||||0.7718|||||||Cochran-Mantel-Haenszel|||||||0.7718
73890688|NCT04634253|147313772|SUPERIORITY||LS Mean|-0.88|STANDARD_ERROR_OF_MEAN|0.361||0.017|TWO_SIDED|95.0|-1.6|-0.16|||Mixed Models Analysis|||||-0.16|-1.60|0.017
73890689|NCT04634253|147313772|SUPERIORITY||LS Mean|-1.09|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-1.73|-0.46|||Mixed Models Analysis|||||-0.46|-1.73|<0.001
73890690|NCT04634253|147313773|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.29|3.44|||Regression, Logistic|||||3.44|0.29|0.997
73890691|NCT04634253|147313773|SUPERIORITY||Odds Ratio (OR)|3.4||||0.032|TWO_SIDED|95.0|1.11|10.4|||Regression, Logistic|||||10.40|1.11|0.032
73890692|NCT04634253|147313774|SUPERIORITY||Odds Ratio (OR)|0.29||||0.235|TWO_SIDED|95.0|0.04|2.25|||Regression, Logistic|||||2.25|0.04|0.235
73890693|NCT04634253|147313774|SUPERIORITY||Odds Ratio (OR)|1.37||||0.661|TWO_SIDED|95.0|0.33|5.61|||Regression, Logistic|||||5.61|0.33|0.661
73890694|NCT04634253|147313775|SUPERIORITY||Odds Ratio (OR)|0.97||||0.965|TWO_SIDED|95.0|0.22|4.28|||Regression, Logistic|||||4.28|0.22|0.965
73890695|NCT04634253|147313775|SUPERIORITY||Odds Ratio (OR)|2.91||||0.098|TWO_SIDED|95.0|0.82|10.33|||Regression, Logistic|||||10.33|0.82|0.098
73890696|NCT04634253|147313776|SUPERIORITY||LS Mean Difference|-11.26|STANDARD_ERROR_OF_MEAN|3.71||0.003|TWO_SIDED|95.0|-18.65|-3.87|||Mixed Models Analysis|||||-3.87|-18.65|0.003
73890697|NCT04634253|147313776|SUPERIORITY||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|3.265|<|0.001|TWO_SIDED|95.0|-19.61|-6.6|||Mixed Models Analysis|||||-6.60|-19.61|<0.001
73890698|NCT04634253|147313777|SUPERIORITY||LS Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|3.782||0.008|TWO_SIDED|95.0|-17.83|-2.77|||Mixed Models Analysis|||||-2.77|-17.83|0.008
73890699|NCT04634253|147313777|SUPERIORITY||LS Mean Difference|-11.76|STANDARD_ERROR_OF_MEAN|3.282|<|0.001|TWO_SIDED|95.0|-18.29|-5.22|||Mixed Models Analysis|||||-5.22|-18.29|<0.001
73890700|NCT04634253|147313778|SUPERIORITY||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.365||0.218|TWO_SIDED|95.0|-7.63|1.77|||ANCOVA|||Mental Component Score (MCS)||1.77|-7.63|0.218
73890701|NCT04634253|147313778|SUPERIORITY||LS Mean Difference|1.15|STANDARD_ERROR_OF_MEAN|2.065||0.578|TWO_SIDED|95.0|-2.95|5.26|||ANCOVA|||Mental Component Score (MCS)||5.26|-2.95|0.578
73890702|NCT04634253|147313778|SUPERIORITY||LS Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|2.368||0.396|TWO_SIDED|95.0|-2.69|6.73|||ANCOVA|||Physical Component Score (PCS)||6.73|-2.69|0.396
73890703|NCT04634253|147313778|SUPERIORITY||LS Mean Difference|1.42|STANDARD_ERROR_OF_MEAN|2.057||0.493|TWO_SIDED|95.0|-2.67|5.5|||ANCOVA|||Physical Component Score (PCS)||5.50|-2.67|0.493
73890704|NCT01499355|147313783|SUPERIORITY_OR_OTHER|||||||0.367||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, rest of world \[ROW\]) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard|||||||0.367
73890705|NCT01499355|147313783|SUPERIORITY_OR_OTHER|||||||0.283||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard|||||||0.283
73890706|NCT01499355|147313784|SUPERIORITY_OR_OTHER|||||||0.0486||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel|||||||0.0486
73890707|NCT01499355|147313784|SUPERIORITY_OR_OTHER|||||||0.0668||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel|||||||0.0668
73890708|NCT01499355|147313785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0628||||0.0456|TWO_SIDED|90.0|0.0081|0.4843||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic|||||0.4843|0.0081|0.0456
73890709|NCT01499355|147313785|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4344||||0.5455|TWO_SIDED|90.0|0.0996|1.8941||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic|||||1.8941|0.0996|0.5455
73890710|NCT01499355|147313785|SUPERIORITY_OR_OTHER|||||||0.0252|||||||Cochran-Mantel-Haenszel|||||||0.0252
73890711|NCT01499355|147313785|SUPERIORITY_OR_OTHER|||||||0.2876|||||||Cochran-Mantel-Haenszel|||||||0.2876
73890712|NCT01499355|147313788|SUPERIORITY_OR_OTHER|||||||0.863|||||||Regression, Cox|||||||0.863
73890713|NCT01499355|147313788|SUPERIORITY_OR_OTHER|||||||0.769|||||||Regression, Cox|||||||0.769
73890714|NCT01499355|147313788|SUPERIORITY_OR_OTHER|||||||0.907|||||||ANCOVA|||||||0.907
73890715|NCT01499355|147313788|SUPERIORITY_OR_OTHER|||||||0.996|||||||ANCOVA|||||||0.996
73890716|NCT01526733|147313789|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.15|||<|0.0001|TWO_SIDED|90.0|1.71|2.71||Comparison of Day 1 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||||2.71|1.71|<0.0001
73890717|NCT01526733|147313789|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.62|||<|0.0001|TWO_SIDED|90.0|2.08|3.29||Comparison of Day 4 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||||3.29|2.08|<0.0001
73890718|NCT02395081|147313799|SUPERIORITY|||||||0.7||||||SBP wk 16-20|ANOVA|||||||0.70
73890719|NCT02395081|147313801|SUPERIORITY|||||||0.49|||||||Chi-squared|||||||0.49
73890720|NCT02395081|147313802|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
73890721|NCT02395081|147313804|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
73890722|NCT02395081|147313805|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
73890723|NCT02395081|147313806|SUPERIORITY|||||||0.24|||||||ANOVA|||||||0.24
73890724|NCT02395081|147313807|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
73890725|NCT02395081|147313808|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
73890726|NCT02395081|147313809|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
73890727|NCT01869764|147313821|OTHER|||||||0.93|||||||ANOVA|||||||0.93
73890728|NCT01869764|147313822|OTHER|||||||0.29|||||||ANOVA|||||||0.29
73890729|NCT01958164|147313856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|73.3|||||TWO_SIDED|95.0|23.3|89.3|||||Difference calculated as actilyse minus saline solution|||89.3|23.3|
73890730|NCT01958164|147313857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.7|||||TWO_SIDED|95.0|20.7|90.3|||||Difference calculated as actilyse minus saline solution|||90.3|20.7|
73890731|NCT02963506|147313861|OTHER||Correlation statistic|17.9|||<|0.001|||||||Cochran-Mantel-Haenszel|||Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.||||<0.001
73890732|NCT02963506|147313861|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|2.6|||=|0.04|TWO_SIDED|95.0|1.04|6.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior tumor necrosis factor (TNF) inhibitor exposure.||6.48|1.04|=0.040
73890733|NCT02963506|147313861|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|4.5|||=|0.001|TWO_SIDED|95.0|1.83|10.86||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||10.86|1.83|=0.001
73890734|NCT02963506|147313861|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|5.5|||<|0.001|TWO_SIDED|95.0|2.27|13.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||13.48|2.27|<0.001
73890735|NCT02963506|147313861|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|5.3|||<|0.001|TWO_SIDED|95.0|2.19|12.92||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||12.92|2.19|<0.001
73890736|NCT02963506|147313862|OTHER||LS Mean Difference vs placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-0.86|-0.24|||ANCOVA|||Least squares (LS) Mean, standard error, confidence interval and p-value were derived using the analysis of covariance (ANCOVA) model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.24|-0.86|<0.001
73890737|NCT02963506|147313862|OTHER||LS Mean Difference vs placebo|-1.2|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.47|-0.83|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.83|-1.47|<0.001
73890738|NCT02963506|147313862|OTHER||LS Mean Difference vs placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.35|-0.72|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.72|-1.35|<0.001
73890739|NCT02963506|147313862|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.45|-0.82|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.82|-1.45|<0.001
73890740|NCT02963506|147313863|OTHER||Odds Ratio (OR)|1.7|||=|0.163|TWO_SIDED|95.0|0.8|3.67||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||3.67|0.80|=0.163
73890741|NCT02963506|147313863|OTHER||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|1.84|8.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||8.48|1.84|<0.001
73890742|NCT02963506|147313863|OTHER||Odds Ratio (OR)|3.5|||=|0.001|TWO_SIDED|95.0|1.66|7.61||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||7.61|1.66|=0.001
73890743|NCT02963506|147313863|OTHER||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|2.92|14.28||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||14.28|2.92|<0.001
73890744|NCT02963506|147313864|OTHER||Odds Ratio (OR)|5.3|||=|0.003|TWO_SIDED|95.0|1.74|15.96||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||15.96|1.74|=0.003
73890745|NCT02963506|147313864|OTHER||Odds Ratio (OR)|11.9|||<|0.001|TWO_SIDED|95.0|4.03|35.38||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||35.38|4.03|<0.001
73890746|NCT02963506|147313864|OTHER||Odds Ratio (OR)|14.3|||<|0.001|TWO_SIDED|95.0|4.81|42.46||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||42.46|4.81|<0.001
73890747|NCT02963506|147313864|OTHER||Odds Ratio (OR)|14.9|||<|0.001|TWO_SIDED|95.0|5.02|44.27||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||44.27|5.02|<0.001
73890748|NCT02963506|147313865|OTHER||LS Mean Difference vs placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.36|=|0.094|TWO_SIDED|95.0|-1.31|0.1|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||0.10|-1.31|=0.094
73890749|NCT02963506|147313865|OTHER||LS Mean Difference vs placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.34|-0.91|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.91|-2.34|<0.001
73890750|NCT02963506|147313865|OTHER||LS Mean Difference vs placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.35|-0.91|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.91|-2.35|<0.001
73890751|NCT02963506|147313865|OTHER||LS Mean Difference vs placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.6|-1.18|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-1.18|-2.60|<0.001
73890752|NCT02963506|147313866|OTHER||LS Mean Difference vs placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.36|=|0.075|TWO_SIDED|95.0|-1.35|0.07|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||0.07|-1.35|=0.075
73890753|NCT02963506|147313866|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.36|=|0.003|TWO_SIDED|95.0|-1.79|-0.37|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.37|-1.79|=0.003
73890754|NCT02963506|147313866|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.36|=|0.002|TWO_SIDED|95.0|-1.84|-0.42|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.42|-1.84|=0.002
73890755|NCT02963506|147313866|OTHER||LS Mean Difference vs placebo|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.22|-0.81|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.81|-2.22|<0.001
73890756|NCT01397968|147313870|SUPERIORITY||||||<|0.0001|||||||Wilcoxon rank sum|||||||<0.0001
73890757|NCT01397968|147313871|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
73890758|NCT02970162|147313881|SUPERIORITY|||||||0.0004||||||LS means|Least square means|Fixed effects treatment and QMG at Baseline. Between-treatment difference in LS means (95% CI) -6.54 (-9.78, -3.29).||||||0.0004
73890759|NCT02970162|147313882|SUPERIORITY||LS means|2.95||||0.0003|TWO_SIDED|95.0|1.53|4.38||CFB for SGI score was modeled as the response, with fixed effects terms for treatment and SGI at Baseline|Fixed effects linear model|This statistical test applies to the change from baseline SGI scores to Day 4 values row.||||4.38|1.53|0.0003
73890760|NCT02970162|147313883|SUPERIORITY|||||||0.002|||||||Wilcoxon Rank Sum Test|||||||0.0020
73890761|NCT02970162|147313884|SUPERIORITY|||||||0.0112|||||||Fisher Exact|||||||0.0112
73890762|NCT00750438|147313885|SUPERIORITY|||||||0.972|||||||Regression, Linear|||||||0.972
73890763|NCT00750438|147313886|SUPERIORITY|||||||0.559|||||||t-test, 2 sided|||Baseline and 24 weeks||||0.559
73890764|NCT00750438|147313886|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.062
73890765|NCT00750438|147313886|SUPERIORITY|||||||0.099|||||||Regression, Linear|||||||0.099
73890766|NCT00750438|147313887|SUPERIORITY|||||||0.036|||||||Regression, Linear|||||||0.036
73890767|NCT00750438|147313888|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.001
73890768|NCT00750438|147313888|SUPERIORITY|||||||0.723|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.723
73890769|NCT00750438|147313888|SUPERIORITY|||||||0.027|||||||Regression, Linear|||||||0.027
73890770|NCT00750438|147313889|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
73890771|NCT00750438|147313889|SUPERIORITY|||||||0.644|||||||t-test, 2 sided|||||||0.644
73890772|NCT00750438|147313889|SUPERIORITY|||||||0.549|||||||Regression, Linear|||||||0.549
73890773|NCT04845568|147313915|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|2.08||0.592|TWO_SIDED|95.0|-3.16|5.43||A priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Self-Efficacy for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for physical activity does not differ between conditions.||5.43|-3.16|0.592
73890774|NCT04845568|147313915|SUPERIORITY||Mean Difference (Net)|-1.19|STANDARD_ERROR_OF_MEAN|1.56||0.453|TWO_SIDED|95.0|-4.39|2.02||A priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Self-Efficacy for Healthy Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for healthy eating does not differ between conditions.||2.02|-4.39|0.453
73890775|NCT04845568|147313916|SUPERIORITY||Mean Difference (Net)|0.275|STANDARD_ERROR_OF_MEAN|0.3||0.368|TWO_SIDED|95.0|-0.342|0.892||A priori threshold for statistical significance set at p\< 0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Caregiver Readiness to Change Child's Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in readiness for healthy eating does not differ between conditions.||.892|-.342|.368
73890776|NCT04845568|147313916|SUPERIORITY||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.34||0.714|TWO_SIDED|95.0|-0.575|0.827||A priori threshold for statistical significance set at p\< .05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Caregiver Readiness for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions to help child improve physical activity from baseline to two-week follow up does not differ between conditions.||.827|-.575|.714
73890777|NCT04845568|147313917|SUPERIORITY||Mean Difference (Net)|-0.522|STANDARD_ERROR_OF_MEAN|1.88||0.783|TWO_SIDED|95.0|-4.39|3.34||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child attitudes toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child attitudes toward healthy eating from baseline to post-intervention does not differ between conditions.||3.34|-4.39|.783
73890778|NCT04845568|147313917|SUPERIORITY||Mean Difference (Net)|-1.99|STANDARD_ERROR_OF_MEAN|1.97||0.323|TWO_SIDED|95.0|-6.05|2.07||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intentions toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child intentions toward healthy eating from baseline to post-intervention does not differ between conditions.||2.07|-6.05|.323
73890779|NCT04845568|147313917|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|1.89||0.276|TWO_SIDED|95.0|-1.79|6.01||A priori threshold for statistical significance is set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in caregiver intentions toward helping their child engage in healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions from baseline to post-intervention does not differ between conditions.||6.01|-1.79|.276
73890780|NCT04845568|147313918|SUPERIORITY||Mean Difference (Net)|0.247|STANDARD_ERROR_OF_MEAN|0.4||0.547|TWO_SIDED|95.0|-0.59|1.08||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of fruits. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fruit servings per week from baseline to two-week follow up does not differ between conditions.||1.08|-.59|.547
73890781|NCT04845568|147313918|SUPERIORITY||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.42||0.99|TWO_SIDED|95.0|-0.87|0.86||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of vegetables. It is an independent samples t test. It is testing the null hypothesis that the mean change in child vegetable servings per week from baseline to two-week follow up does not differ between conditions.||.86|-.87|.990
73890782|NCT04845568|147313918|SUPERIORITY||Mean Difference (Net)|-0.203|STANDARD_ERROR_OF_MEAN|0.32||0.527|TWO_SIDED|95.0|-0.86|0.45||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of fast food. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fast food servings per week from baseline to two-week follow up does not differ between conditions.||.45|-.86|.527
73890783|NCT04845568|147313919|SUPERIORITY||Mean Difference (Net)|-0.159|STANDARD_ERROR_OF_MEAN|0.55||0.777|TWO_SIDED|95.0|-1.33|1.01||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child weekly intake of breakfast. It is an independent samples t test. It is testing the null hypothesis that the mean change in child breakfast meals per week from baseline to two-week follow up does not differ between conditions.||1.01|-1.33|.777
73890784|NCT04845568|147313919|SUPERIORITY||Mean Difference (Net)|-0.736|STANDARD_ERROR_OF_MEAN|0.74||0.329|TWO_SIDED|95.0|-2.26|0.79||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of family dinners. It is an independent samples t test. It is testing the null hypothesis that the mean change in child family dinners per week from baseline to two-week follow up does not differ between conditions.||.79|-2.26|.329
73890785|NCT04845568|147313920|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.26||0.086|TWO_SIDED|95.0|-0.07|0.99||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child screentime. It is an independent samples t test. It is testing the null hypothesis that the mean change in child screentime per week from baseline to two-week follow up does not differ between conditions.||.99|-0.07|.086
73890786|NCT04845568|147313920|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.64|TWO_SIDED|95.0|-0.64|0.4||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child active hours. It is an independent samples t test. It is testing the null hypothesis that the mean change in child active hours per week from baseline to two-week follow up does not differ between conditions.||.40|-.64|.64
73890787|NCT01732718|147313951|SUPERIORITY|||||||0.51|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.51
73890788|NCT01732718|147313952|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
73890789|NCT01732718|147313954|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
73890790|NCT01732718|147313956|SUPERIORITY|||||||0.57|||||||see comments for explanation|albuminuria examined as continuous variable (linear mixed model to analyze effect) and categorical generalized variable (estimating equation approach)||||||0.57
73890791|NCT01732718|147313960|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
73890792|NCT01732718|147313961|SUPERIORITY|||||||0.1469|||||||t-test, 1 sided|||Comparison of the change in AMC||||0.1469
73890793|NCT01732718|147313961|SUPERIORITY|||||||0.2382|||||||t-test, 1 sided|||Comparison of the change in ALC||||0.2382
73890794|NCT01732718|147313961|SUPERIORITY|||||||0.5833|||||||t-test, 1 sided|||Comparison of the change in ANC||||0.5833
73890795|NCT01732718|147313964|SUPERIORITY|||||||0.5184|||||||Wilcoxon (Mann-Whitney)|||||||0.5184
73890796|NCT00499616|147313976|OTHER||Log Rank Test Statistic|0.9841||||0.3212|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients between 12-18 months of age with Stage 4 neuroblastoma and favorable biological features on ANBL0531 and patients less than 12 months of age with Stage 4 neuroblastoma on A3961 were compared using the log-rank test.||||.3212
73890797|NCT00499616|147313980|OTHER||Log-Rank Test Statistic|5.0049||||0.0253|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.||||.0253
73890798|NCT00499616|147313981|OTHER|The overall survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.|Log Rank Test Statistic|2.6709||||0.1022|TWO_SIDED|95.0|||||Log Rank|||||||.1022
73890799|NCT00499616|147313982|OTHER||Chi-Square Test Statistic|9.9111||||0.0016|TWO_SIDED|95.0|||||Chi-squared|||The association between extent of surgical resection with occurrence of complications was determined using the chi-square test.||||.0016
73890800|NCT00123422|147313989|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||Statistical tests were 2-sided and a p value of \< 0.05 was the criterion for statistical significance.|ANCOVA|The baseline value was the co-variate in this analysis.||||||0.015
73890801|NCT00123422|147313990|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|The baseline value was the co-variate in this analysis.||||||<0.05
73890802|NCT04555616|147313991|OTHER|||||||0.12|||||||Fisher Exact|||Primary outcome analyzed via success rates among groups.||||0.12
73890803|NCT03089281|147313994|SUPERIORITY|||||||0.17|||||||Chi-squared|||||||0.17
73890804|NCT03089281|147313995|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
73890805|NCT03089281|147313996|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||0.029
73890806|NCT03089281|147313998|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.050
73890807|NCT03089281|147313999|SUPERIORITY|||||||0.49|||||||Cochran-Armitage Trend Test|||||||0.49
73890808|NCT03089281|147314000|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
73890809|NCT03089281|147314001|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
73890810|NCT03089281|147314002|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
73890811|NCT03089281|147314003|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
73890812|NCT03089281|147314004|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
73890813|NCT03089281|147314005|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
73890814|NCT03089281|147314006|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
73890815|NCT01554241|147314031|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Results presented were Bonferonni-corrected for a mid-point safety analysis||Comparisons of concentrations in D3 dosing groups at study end were made by ANOVA. Adherence of 80% was pre-specified for inclusion in analyses. .||||<.0001
73890816|NCT01554241|147314031|SUPERIORITY_OR_OTHER||||||=|0.56|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||=.56
73890817|NCT01554241|147314031|SUPERIORITY_OR_OTHER||||||<|0.0009|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0009
73890818|NCT01554241|147314031|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
73890819|NCT01554241|147314031|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.006
73890820|NCT01554241|147314031|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
73890821|NCT01554241|147314031|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
73890822|NCT01554241|147314032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||analyses were corrected for multiple comparisons (Bonferroni)|ANOVA|||||||<.0001
73890823|NCT01554241|147314032|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||=0.47
73890824|NCT01554241|147314032|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.002
73890825|NCT01554241|147314032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
73890826|NCT01554241|147314032|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.02
73890827|NCT01554241|147314032|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
73890828|NCT01554241|147314032|SUPERIORITY_OR_OTHER||||||<|0.0003|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0003
73890829|NCT00220636|147314051|SUPERIORITY_OR_OTHER||t statistic|4.7|||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the HDRS score pre- to post- treatment with aripiprazole.||||<.001
73890830|NCT00220636|147314053|SUPERIORITY_OR_OTHER||t statistic|-3.1||||0.009|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the GAFS score pre- to post- treatment with aripiprazole.||||.009
73890831|NCT00220636|147314054|SUPERIORITY_OR_OTHER||t statistic|3.1||||0.008|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the BDI score pre- to post- treatment with aripiprazole.||||.008
73890832|NCT00539942|147314062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||<|0.05|||||||Chi-squared|||Unable to analyze data||||<.05
73890833|NCT00408200|147314077|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
73890834|NCT01995838|147314137|SUPERIORITY||LS Mean Difference|0.51||||0.0651|TWO_SIDED|95.0|-0.03|1.06|||ANCOVA|Baseline value and treatment as covariates.||||1.06|-0.03|0.0651
73890835|NCT01995838|147314137|SUPERIORITY||LS Mean Difference|0.13||||0.649|TWO_SIDED|95.0|-0.44|0.7|||ANCOVA|Baseline value and treatment as covariates.||||0.70|-0.44|0.6490
73890836|NCT01995838|147314137|SUPERIORITY||LS Mean Difference|0.43||||0.1059|TWO_SIDED|95.0|-0.09|0.94|||ANCOVA|Baseline value and treatment as covariates.||||0.94|-0.09|0.1059
73890837|NCT01995838|147314137|SUPERIORITY||LS Mean Difference|0.01||||0.9818|TWO_SIDED|95.0||0.55|||ANCOVA|Baseline value and treatment as covariates.||||0.55|-0. 54|0. 9818
73890838|NCT01995838|147314137|SUPERIORITY||LS Mean Difference|0.38||||0.1071|TWO_SIDED|95.0|-0.08|0.85|||ANCOVA|Baseline value and treatment as covariates.||||0.85|-0.08|0. 1071
73890839|NCT01995838|147314137|SUPERIORITY||LS Mean Difference|0.68||||0.0063|TWO_SIDED|95.0|0.19|1.17|||ANCOVA|Baseline value and treatment as covariates.||||1.17|0.19|0.0063
73890840|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|4.57||||0.0083|TWO_SIDED|95.0|1.19|7.94|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||7.94|1.19|0.0083
73890841|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|4.44||||0.0151|TWO_SIDED|95.0|0.86|8.01|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||8.01|0.86|0.0151
73890842|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|5.74||||0.0005|TWO_SIDED|95.0|2.54|8.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||8.93|2.54|0.0005
73890843|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|8.09|||<|0.0001|TWO_SIDED|95.0|4.73|11.45|||ANCOVA|||Days 1-2||11.45|4.73|<0.0001
73890844|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|10.06|||<|0.0001|TWO_SIDED|95.0|7.2|12.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||12.93|7.20|<0.0001
73890845|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|10.13|||<|0.0001|TWO_SIDED|95.0|7.18|13.08|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||13.08|7.18|<0.0001
73890846|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|0.34||||0.8505|TWO_SIDED|95.0|-3.22|3.9|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||3.90|-3.22|0.8505
73890847|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|3.94||||0.038|TWO_SIDED|95.0|0.22|7.66|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||7.66|0.22|0.0380
73890848|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|5.76||||0.0008|TWO_SIDED|95.0|2.4|9.12|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||9.12|2.40|0.0008
73890849|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|7.78|||<|0.0001|TWO_SIDED|95.0|4.24|11.32|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||11.32|4.24|<0.0001
73890850|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|7.89|||<|0.0001|TWO_SIDED|95.0|4.86|10.92|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||10.92|4.86|<0.0001
73890851|NCT01995838|147314138|SUPERIORITY||LS Mean Difference|8.87|||<|0.0001|TWO_SIDED|95.0|5.72|12.02|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||12.02|5.72|<0.0001
73890852|NCT01995838|147314139|SUPERIORITY||Geometric Mean Ratio|0.77||||0.1407|TWO_SIDED|95.0|0.54|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||1.09|0.54|0.1407
73890853|NCT01995838|147314139|SUPERIORITY|Days 1-2|Geometric Mean Ratio|0.55||||0.0018|TWO_SIDED|95.0|0.38|0.8|||ANCOVA|Baseline value and treatment as covariates.||||0.80|0.38|0.0018
73890854|NCT01995838|147314139|SUPERIORITY||Geometric Mean Ratio|0.6||||0.0025|TWO_SIDED|95.0|0.43|0.83|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.83|0.43|0.0025
73890855|NCT01995838|147314139|SUPERIORITY||Geometric Mean Ratio|0.54||||0.0006|TWO_SIDED|95.0|0.38|0.76|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.76|0.38|0.0006
73890856|NCT01995838|147314139|SUPERIORITY||Geometric Mean Ratio|0.52|||<|0.0001|TWO_SIDED|95.0|0.38|0.7|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.70|0.38|<0.0001
73890857|NCT01995838|147314139|SUPERIORITY||Geometric Mean Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.29|0.54|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2:||0.54|0.29|<0.0001
73890858|NCT01995838|147314139|SUPERIORITY||Geometric Mean Ratio|0.73||||0.1158|TWO_SIDED|95.0|0.49|1.08|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||1.08|0.49|0.1158
73890859|NCT01995838|147314139|SUPERIORITY||Geometric Mean Ratio|0.49||||0.001|TWO_SIDED|95.0|0.33|0.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.75|0.33|0.0010
73890860|NCT01995838|147314139|SUPERIORITY||Geometric Mean Ratio|0.47|||<|0.0001|TWO_SIDED|95.0|0.32|0.69|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.69|0.32|<0.0001
73890861|NCT01995838|147314139|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.47|0.21|<0.0001
73890862|NCT01995838|147314139|SUPERIORITY||Geometric Mean Ratio|0.41|||<|0.0001|TWO_SIDED|95.0|0.29|0.57|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.57|0.29|<0.0001
73890863|NCT01995838|147314139|SUPERIORITY||Geometric Mean Ratio|0.34|||<|0.0001|TWO_SIDED|95.0|0.24|0.48|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.48|0.24|<0.0001
73890864|NCT01995838|147314140|SUPERIORITY||LS Mean Difference|-11.08||||0.105|TWO_SIDED|95.0|-24.48|2.33|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||2.33|-24.48|0.1050
73890865|NCT01995838|147314140|SUPERIORITY||LS Mean Difference|-2.29||||0.7501|TWO_SIDED|95.0|-16.46|11.87|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||11.87|-16.46|0.7501
73890866|NCT01995838|147314140|SUPERIORITY||LS Mean Difference|-11.26||||0.0818|TWO_SIDED|95.0|-23.94|1.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||1.43|-23.94|0.0818
73890867|NCT01995838|147314140|SUPERIORITY||LS Mean Difference|-19.81||||0.0038|TWO_SIDED|95.0|-33.18|-6.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||-6.43|-33.18|0.0038
73890868|NCT01995838|147314140|SUPERIORITY||LS Mean Difference|-29.34|||<|0.0001|TWO_SIDED|95.0|-40.75|17.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||17.93|-40.75|<0.0001
73890869|NCT01995838|147314140|SUPERIORITY||LS Mean Difference|-25.84|||<|0.0001|TWO_SIDED|95.0|-37.59|-14.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||-14.09|-37.59|<0.0001
73890870|NCT01995838|147314140|SUPERIORITY||LS Mean Difference|0.4642||||0.4642|TWO_SIDED|95.0|-9.6|20.98|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||20.98|-9.60|0.4642
73890871|NCT01995838|147314140|SUPERIORITY|Baseline value and treatment as covariates.|LS Mean Difference|-2.31||||0.7754|TWO_SIDED|95.0|-18.27|13.64|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||13.64|-18.27|0.7754
73890872|NCT01995838|147314140|SUPERIORITY||LS Mean Difference|-10.69||||0.1461|TWO_SIDED|95.0|-25.14|3.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||3.75|-25.14|0.1461
73890873|NCT01995838|147314140|SUPERIORITY||LS Mean Difference|-14.73||||0.0581|TWO_SIDED|95.0|-29.97|0.51|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.51|-29.97|0.0581
73890874|NCT01995838|147314140|SUPERIORITY||LS Mean Difference|-20.8||||0.0019|TWO_SIDED|95.0|-33.86|-7.74|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||-7.74|-33.86|0.0019
73890875|NCT01995838|147314140|SUPERIORITY||LS Mean Difference|-21.52||||0.002|TWO_SIDED|95.0|-35.12|-7.91|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||-7.91|-35.12|0.0020
73890876|NCT01995838|147314144|SUPERIORITY||LS Mean Difference|-3.05||||0.1483|TWO_SIDED|95.0|-7.2|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||1.09|-7.20|0.1483
73890877|NCT01995838|147314144|SUPERIORITY||LS Mean Difference|-0.64||||0.772|TWO_SIDED|95.0|-4.96|3.69|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||3.69|-4.96|0.7720
73890878|NCT01995838|147314144|SUPERIORITY||LS Mean Difference|1.5||||0.4548|TWO_SIDED|95.0|-2.44|5.44|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||5.44|-2.44|0.4548
73890879|NCT01995838|147314144|SUPERIORITY||LS Mean Difference|-2.39||||0.253|TWO_SIDED|95.0|-6.51|1.72|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||1.72|-6.51|0.2530
73890880|NCT01995838|147314144|SUPERIORITY||LS Mean Difference|2.41||||0.1794|TWO_SIDED|95.0|-1.11|5.93|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||5.93|-1.11|0.1794
73890881|NCT01995838|147314144|SUPERIORITY||LS Mean Difference|0.94||||0.6148|TWO_SIDED|95.0|-2.74|4.63|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||4.63|-2.74|0.6148
73890882|NCT00439517|147314185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.0048|TWO_SIDED|95.0|0.515|0.889|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||0.889|0.515|0.0048
73890883|NCT00439517|147314186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.756||||0.016|TWO_SIDED|95.0|1.11|2.777|||Cochran-Mantel-Haenszel|Stratified odds ratio and Cochran-Mantel- Haenszel (CMH) statistics were calculated considering the randomization strata.||||2.777|1.110|0.016
73890884|NCT00439517|147314187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.855||||0.3797|TWO_SIDED|95.0|0.603|1.213|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.213|0.603|0.3797
73890885|NCT00439517|147314188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977||||0.8575|TWO_SIDED|95.0|0.755|1.263|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||1.263|0.755|0.8575
73890886|NCT03511937|147314212|SUPERIORITY||Mean Difference (Final Values)|-31.4||||0.02|TWO_SIDED|95.0|-57.9|-5.0||The a priori threshold for statistical significance was \< 0.05.|Two-part regression model with robust SE|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||-5.0|-57.9|0.02
73890887|NCT03511937|147314213|SUPERIORITY||Mean Difference (Final Values)|-69.4||||0.55|TWO_SIDED|95.0|-295.5|156.6||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||156.6|-295.5|0.55
73890888|NCT03511937|147314214|SUPERIORITY||Mean Difference (Final Values)|-13.0||||0.006|TWO_SIDED|95.0|-23.0|-4.0||The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|Analyses controlled for overweight/obesity status and Hispanic ethnicity, which were unbalanced between treatment arms.|Analyses used logistic regression to calculate mean difference in predicted probability of purchasing a sugar-sweetened beverage.|||-4|-23|0.006
73890889|NCT03511937|147314215|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.01|TWO_SIDED|95.0|-0.4|-0.1||The a priori threshold for statistical significance was \< 0.05.|Negative binomial regression|Analyses controlled for overweight/obesity status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||-0.1|-0.4|0.010
73890890|NCT03511937|147314216|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.403|TWO_SIDED|95.0|-0.2|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for obesity status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust standard errors.||||0.5|-0.2|0.403
73890891|NCT03511937|147314217|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.005|TWO_SIDED|95.0|0.1|0.8||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.8|0.1|0.005
73890892|NCT03511937|147314218|SUPERIORITY||Mean Difference (Final Values)|37.0|||<|0.001|TWO_SIDED|95.0|32.0|43.0||The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between treatment arms.|Analyses used logistic regression to calculate mean difference in predicted probability of purchasing a sugar-sweetened beverage.|||43|32|<0.001
73890893|NCT03511937|147314219|SUPERIORITY||Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|1.4|1.9||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.9|1.4|<0.001
73890894|NCT03511937|147314220|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.5|0.3|<0.001
73890895|NCT03511937|147314221|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.3|0.9|<0.001
73890896|NCT03511937|147314222|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.1|0.7|<0.001
73890897|NCT03511937|147314223|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.055|TWO_SIDED|95.0|-0.001|0.13||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.13|-0.001|0.055
73890898|NCT03511937|147314224|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.258|TWO_SIDED|95.0|-0.27|0.07||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.07|-0.27|0.258
73890899|NCT03511937|147314225|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.416|TWO_SIDED|95.0|-0.3|0.13||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.13|-0.30|0.416
73890900|NCT03511937|147314226|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.609|TWO_SIDED|95.0|-0.14|0.24||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.24|-0.14|0.609
73890901|NCT03511937|147314227|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.002|TWO_SIDED|95.0|0.1|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.5|0.1|0.002
73890902|NCT03511937|147314228|SUPERIORITY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.8|2.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||2.3|1.8|<0.001
73890903|NCT03511937|147314229|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.311|TWO_SIDED|95.0|-0.23|0.07||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.07|-0.23|0.311
73890904|NCT03511937|147314230|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.253|TWO_SIDED|95.0|-0.3|0.08||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.08|-0.30|0.253
73890905|NCT03511937|147314231|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.658|TWO_SIDED|95.0|-0.22|0.14||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.14|-0.22|0.658
73890906|NCT03511937|147314232|SUPERIORITY||Mean Difference (Final Values)|-49.5||||0.661|TWO_SIDED|95.0|-271.3|172.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||172.3|-271.3|0.661
73890907|NCT03511937|147314233|SUPERIORITY||Mean Difference (Final Values)|12.5||||0.082|TWO_SIDED|95.0|-1.6|26.6||The a priori threshold for statistical significance was \< 0.05.|Two-part regression model with robust SE|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||26.6|-1.6|0.082
73890908|NCT02983552|147314235|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.71|TWO_SIDED|95.0|-2.2|1.7||a priori threshold for statistical significance: 2-sided type I error rate of 5%|ANOVA|Adjusted for baseline amblyopic-eye visual acuity.|A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 4 week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 4 weeks. A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 4 weeks. There was no imputation for missing data.||1.7|-2.2|0.71
73890909|NCT02983552|147314237|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|98.3|-2.4|2.1|||||A 2-sided 98.3% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 8-week visit.|||2.1|-2.4|
73890910|NCT02983552|147314243|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|98.3|-13.0|9.0||||||Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 4-week visit, adjusted for visual acuity at randomization.||9|-13|
73890911|NCT02983552|147314244|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|98.3|-15.0|12.0||||||Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 8-week visit, adjusted for visual acuity at randomization.|For secondary visual acuity outcomes, which included the 8-week treatment group comparison, a Bonferroni adjustment was used to control for multiple testing (3 outcomes tested) to preserve the overall type I error rate at 5% (2-sided alpha=0.017 per test).|12|-15|
73890912|NCT02983552|147314246|SUPERIORITY|||||||0.38||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group.|Wilcoxon (Mann-Whitney)|||||||0.38
73890913|NCT02983552|147314248|SUPERIORITY|||||||0.53||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group.|Wilcoxon (Mann-Whitney)|||||||0.53
73890914|NCT02983552|147314250|SUPERIORITY|||||||0.19||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group for participants without strabismus.|Wilcoxon (Mann-Whitney)|||||||0.19
73890915|NCT02983552|147314252|SUPERIORITY|||||||0.74||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group for participants without strabismus.|Wilcoxon (Mann-Whitney)|||||||0.74
73890916|NCT02983552|147314257|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|99.0|-2.5|0.4|||||Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 4 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.||0.4|-2.5|
73890917|NCT02983552|147314258|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|99.0|-2.3|0.3|||||Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 8 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.||0.3|-2.3|
73890918|NCT02983552|147314259|SUPERIORITY|||||||0.37|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 4-week visit.||||0.37
73890919|NCT02983552|147314260|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 8-week visit.||||0.99
73890920|NCT02983552|147314261|SUPERIORITY|||||||0.2|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.20
73890921|NCT02983552|147314262|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
73890922|NCT02983552|147314263|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.||||0.44
73890923|NCT02983552|147314264|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.||||>0.99
73890924|NCT02983552|147314265|SUPERIORITY|||||||0.12|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.12
73890925|NCT02983552|147314266|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
73890926|NCT02983552|147314267|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.||||0.12
73890927|NCT02983552|147314268|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.||||>0.99
73890928|NCT02983552|147314271|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 4-week visit by treatment group.||||0.07
73890929|NCT02983552|147314272|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 8-week visit by treatment group. This was utilized for each item in the survey.||||0.06
73890930|NCT02983552|147314275|SUPERIORITY||||||>|0.01||||||Statistical significance of the interaction term was based on a 2-sided alpha=0.01.|ANCOVA|||An analysis of covariance (ANCOVA) was performed to test the 2-way interaction between treatment group with each factor (baseline age and visual acuity were treated as continuous factors), adjusting for baseline amblyopic-eye visual acuity and the nested terms from the interaction term. Formal subgroup analyses were only performed if there was a minimum of 20 participants in every subgroup category across both treatment groups for factors treated as categorical variables in the model.||||>0.01
73890931|NCT01216189|147314276|SUPERIORITY||Mean change|-0.138||||0.004|TWO_SIDED|95.0|-0.232|-0.044||The threshold for statistical significance was p = 0.05.|Regression, Linear|Model adjusted for menopausal status.||The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).||-0.044|-0.232|0.004
73890932|NCT01216189|147314276|SUPERIORITY||Mean change|-0.011||||0.805|TWO_SIDED|95.0|-0.097|0.075||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for menopausal status.||The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).||0.075|-0.097|0.805
73890933|NCT01216189|147314277|SUPERIORITY||Mean change in FSFI scores|-9.33||||0.013|TWO_SIDED|95.0|-16.66|-1.99||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for Age, Psychological General Well-being total score and relationship with partner.||"The association between mean change in total FSFI score and preoperative RT was assessed using longitudinal regression analysis (GEE), using no preoperative radiotherapy as the reference group."||-1.99|-16.66|0.013
73890934|NCT00125164|147314278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.79|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|1.19|2.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||2.39|1.19|<0.0001
73890935|NCT00125164|147314278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|1.99|3.16||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||3.16|1.99|< 0.0001
73890936|NCT00125164|147314278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.79|STANDARD_ERROR_OF_MEAN|0.26||0.0032||95.0|0.27|1.31|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||1.31|0.27|0.0032
73890937|NCT00125164|147314279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.24|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.50|0.24|< 0.0001
73890938|NCT00125164|147314279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.34|0.6||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.60|0.34|< 0.0001
73890939|NCT00125164|147314279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0495||95.0|0.0|0.22|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.22|0.00|0.0495
73890940|NCT00125164|147314287|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001||95.0|1.26|2.4||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||2.40|1.26|<0.0001
73890941|NCT00125164|147314287|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001||95.0|2.26|3.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||3.39|2.26|<0.0001
73890942|NCT00125164|147314287|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.01|STANDARD_ERROR_OF_MEAN|0.25||0.0002||95.0|0.5|1.51|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||1.51|0.50|0.0002
73890943|NCT00125164|147314288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.25|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.50|0.25|<0.0001
73890944|NCT00125164|147314288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.39|0.64||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.64|0.39|<0.0001
73890945|NCT00125164|147314288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||0.0071||95.0|0.04|0.26|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.26|0.04|0.0071
73890946|NCT02637037|147314304|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||0.99|0.93|
73890947|NCT02637037|147314304|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||TWO_SIDED|90.0|0.96|1.01||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.01|0.96|
73890948|NCT02637037|147314304|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.94|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.00|0.94|
73890949|NCT02637037|147314304|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.00|0.95|
73890950|NCT02637037|147314304|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.96|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.06|0.96|
73890951|NCT02637037|147314304|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.0|||||TWO_SIDED|90.0|0.93|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.07|0.93|
73890952|NCT02637037|147314304|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.05|||||TWO_SIDED|90.0|0.99|1.11||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.11|0.99|
73890953|NCT02637037|147314304|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.03|||||TWO_SIDED|90.0|0.96|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.10|0.96|
73890954|NCT02637037|147314305|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.94|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||0.99|0.94|
73890955|NCT02637037|147314305|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||TWO_SIDED|90.0|0.97|1.02||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.02|0.97|
73890956|NCT02637037|147314305|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.93|0.98||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||0.98|0.93|
73890957|NCT02637037|147314305|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.00|0.95|
73890958|NCT02637037|147314305|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||TWO_SIDED|90.0|0.97|1.08||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.08|0.97|
73890959|NCT02637037|147314305|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.06|0.95|
73890960|NCT02637037|147314305|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.03|||||TWO_SIDED|90.0|0.97|1.09||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.09|0.97|
73890961|NCT02637037|147314305|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.95|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.07|0.95|
73890962|NCT02637037|147314306|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.03|0.93|
73890963|NCT02637037|147314306|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.9|1.06||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.06|0.90|
73890964|NCT02637037|147314306|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.89|1.05||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.05|0.89|
73890965|NCT02637037|147314306|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.95|||||TWO_SIDED|90.0|0.87|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.03|0.87|
73890966|NCT02637037|147314306|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.96|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.07|0.96|
73890967|NCT02637037|147314306|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.92|1.04||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.04|0.92|
73890968|NCT02637037|147314306|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.0|||||TWO_SIDED|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.06|0.95|
73890969|NCT02637037|147314306|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||TWO_SIDED|90.0|0.94|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.10|0.94|
73890970|NCT01469377|147314319|SUPERIORITY||Least squares mean difference|-0.9||||0.2404|TWO_SIDED|95.0|-2.4|0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.6|-2.4|0.2404
73890971|NCT01469377|147314319|SUPERIORITY||Least squares mean difference|-2.2||||0.0114|TWO_SIDED|95.0|-3.7|-0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||-0.6|-3.7|0.0114
73890972|NCT01469377|147314320|SUPERIORITY||Least squares mean difference|-1.1||||0.2404|TWO_SIDED|95.0|-2.5|0.3||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.3|-2.5|0.2404
73890973|NCT01469377|147314320|SUPERIORITY||Least squares mean difference|-1.4||||0.114|TWO_SIDED|95.0|-2.8|0.0||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.0|-2.8|0.1140
73890974|NCT04308291|147314332|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|paired t-test||||||<0.0001
73890975|NCT02453711|147314350|OTHER||Treatment difference (%-points)|-3.7|STANDARD_ERROR_OF_MEAN|1.13|=|0.0055|TWO_SIDED|95.0|-6.55|-0.85|||ANCOVA||Semaglutide 0.05 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-0.85|-6.55|=0.0055
73890976|NCT02453711|147314350|OTHER||Treatment difference (%-points)|-6.32|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-9.16|-3.49|||ANCOVA||Semaglutide 0.1 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-3.49|-9.16|<0.0001
73890977|NCT02453711|147314350|OTHER||Treatment difference (%-points)|-9.31|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-12.15|-6.46|||ANCOVA||Semaglutide 0.2 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-6.46|-12.15|<0.0001
73890978|NCT02453711|147314350|OTHER||Treatment difference (%-points)|-8.88|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-11.72|-6.03|||ANCOVA||Semaglutide 0.3 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-6.03|-11.72|<0.0001
73890979|NCT02453711|147314350|OTHER||Treatment difference (%-points)|-11.55|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-14.38|-8.72|||ANCOVA||Semaglutide 0.4 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-8.72|-14.38|<0.0001
73890980|NCT02908672|147314410|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0224|TWO_SIDED|95.0|0.64|0.97|||Log Rank||Stratified Hazard Ratio|||0.97|0.64|0.0224
73890981|NCT02908672|147314411|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1607|TWO_SIDED|95.0|0.67|1.07|||Log Rank||Stratified Hazard Ratio|||1.07|0.67|0.1607
73890982|NCT02908672|147314412|SUPERIORITY||Difference in response rate|1.63||||0.6997|TWO_SIDED|95.0|-6.9|10.15|||Cochran-Mantel-Haenszel|||||10.15|-6.90|0.6997
73890983|NCT02908672|147314414|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1191|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.1191
73890984|NCT02908672|147314415|SUPERIORITY||Difference in Event Free Rate|8.2||||0.0693|TWO_SIDED|95.0|-0.65|17.04|||Z-test|||||17.04|-0.65|0.0693
73890985|NCT02223702|147314456|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Friedman Test|All rows were compared to eachother||||||<0.01
73890986|NCT02223702|147314457|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|All rows were compared to eachother||||||<0.01
73890987|NCT01039376|147314471|SUPERIORITY||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.43|0.7|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.70|0.43|<0.0001
73890988|NCT01039376|147314472|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.42|0.68|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.68|0.42|<0.0001
73890989|NCT01039376|147314473|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6046|TWO_SIDED|95.0|0.69|1.25|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.25|0.69|0.6046
73890990|NCT01039376|147314475|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0178|TWO_SIDED|95.0|0.62|0.96|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.96|0.62|0.0178
73890991|NCT01039376|147314476|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.3136|TWO_SIDED|95.0|0.42|1.32|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.32|0.42|0.3136
73890992|NCT01039376|147314477|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.1603|TWO_SIDED|95.0|0.29|1.19|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.19|0.29|0.1603
73890993|NCT01039376|147314478|SUPERIORITY||Mean Difference (Final Values)|-2.19||||0.0199|TWO_SIDED|95.0|-4.04|-0.35||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Disease Effects Scale|||-0.35|-4.04|0.0199
73890994|NCT01039376|147314478|SUPERIORITY||Mean Difference (Final Values)|-3.79||||0.0085|TWO_SIDED|95.0|-6.61|-0.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue Scale|||-0.97|-6.61|0.0085
73890995|NCT01039376|147314478|SUPERIORITY||Mean Difference (Final Values)|-3.58||||0.0642|TWO_SIDED|95.0|-7.37|0.21||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Future Health Scale|||0.21|-7.37|0.0642
73890996|NCT01039376|147314478|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.6398|TWO_SIDED|95.0|-1.67|2.72||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Infection Scale|||2.72|-1.67|0.6398
73890997|NCT01039376|147314478|SUPERIORITY||Mean Difference (Final Values)|-4.32||||0.0055|TWO_SIDED|95.0|-7.37|-1.28||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Problems Scale|||-1.28|-7.37|0.0055
73890998|NCT01039376|147314478|SUPERIORITY||Mean Difference (Final Values)|-2.49||||0.0063|TWO_SIDED|95.0|-4.27|-0.71||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Side Effects Scale|||-0.71|-4.27|0.0063
73890999|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.1816|TWO_SIDED|95.0|-3.64|0.69||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Appetite Loss|||0.69|-3.64|0.1816
73891000|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.2863|TWO_SIDED|95.0|-1.18|3.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Cognitive Functioning|||3.97|-1.18|0.2863
73891001|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|-1.97||||0.0932|TWO_SIDED|95.0|-4.28|0.33||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Constipation|||0.33|-4.28|0.0932
73891002|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.6533|TWO_SIDED|95.0|-1.67|2.66||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Diarrhoea|||2.66|-1.67|0.6533
73891003|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|-2.32||||0.0963|TWO_SIDED|95.0|-5.06|0.42||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Dyspnoea|||0.42|-5.06|0.0963
73891004|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|3.89||||0.0037|TWO_SIDED|95.0|1.27|6.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Emotional Functioning|||6.51|1.27|0.0037
73891005|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|-4.63||||0.0013|TWO_SIDED|95.0|-7.45|-1.82||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue|||-1.82|-7.45|0.0013
73891006|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.2902|TWO_SIDED|95.0|-5.02|1.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Financial Difficulties|||1.51|-5.02|0.2902
73891007|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|-1.22||||0.0606|TWO_SIDED|95.0|-2.49|0.05||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Nausea and Vomiting|||0.05|-2.49|0.0606
73891008|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|-3.04||||0.0393|TWO_SIDED|95.0|-5.93|-0.15||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Pain|||-0.15|-5.93|0.0393
73891009|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|1.81||||0.0968|TWO_SIDED|95.0|-0.33|3.96||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Physical Functioning|||3.96|-0.33|0.0968
73891010|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.1449|TWO_SIDED|95.0|-0.61|4.17||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Global Health Status/QOL|||4.17|-0.61|0.1449
73891011|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|3.56||||0.0259|TWO_SIDED|95.0|0.43|6.7||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Role Functioning|||6.70|0.43|0.0259
73891012|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.0175|TWO_SIDED|95.0|0.64|6.65||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Functioning|||6.65|0.64|0.0175
73891013|NCT01039376|147314479|SUPERIORITY||Mean Difference (Final Values)|-1.79||||0.3209|TWO_SIDED|95.0|-5.33|1.75||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Insomnia|||1.75|-5.33|0.3209
73891014|NCT01039376|147314480|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.011|TWO_SIDED|95.0|0.01|0.06||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Utility Score|||0.06|0.01|0.0110
73891015|NCT01039376|147314480|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.1999|TWO_SIDED|95.0|-0.73|3.49||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Thermometer Score|||3.49|-0.73|0.1999
73891016|NCT01039376|147314492|SUPERIORITY||Hazard Ratio (HR)|1.547|||||TWO_SIDED|95.0|1.051|2.276|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 6q-, or +12q or 13q-/no abberation|||2.276|1.051|
73891017|NCT01039376|147314492|SUPERIORITY||Hazard Ratio (HR)|9.303|||||TWO_SIDED|95.0|4.934|17.54|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 17p-/no abberation|||17.540|4.934|
73891018|NCT01039376|147314492|SUPERIORITY||Hazard Ratio (HR)|4.219|||||TWO_SIDED|95.0|2.468|7.21|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 11q-/no abberation|||7.210|2.468|
73891019|NCT01039376|147314492|SUPERIORITY||Hazard Ratio (HR)|1.832|||||TWO_SIDED|95.0|1.434|2.339|||||HR estimated for B2 Microglobulin Group 2 with 3500 as cut off: \>3500 ug/L/\<=3500 ug/L|||2.339|1.434|
73891020|NCT01039376|147314492|SUPERIORITY||Hazard Ratio (HR)|0.573|||||TWO_SIDED|95.0|0.432|0.76|||||HR estimated for IgVH Mutational Status 1 Mutated/Unmutated|||0.760|0.432|
73891021|NCT01039376|147314492|SUPERIORITY||Hazard Ratio (HR)|1.301|||||TWO_SIDED|95.0|0.692|2.448|||||HR estimated for VH3-21 Usage Flag Yes/No.|||2.448|0.692|
73891022|NCT01255436|147314514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.06|TWO_SIDED|95.0|-9.4|1.0||p-value\<0.05 is considered significant|t-test, 1 sided|||||1.0|-9.4|0.06
73891023|NCT01255436|147314515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.14|TWO_SIDED|95.0|-4.1|1.3||p-value \< 0.05 considered significant|t-test, 1 sided|||||1.3|-4.1|0.14
73891024|NCT01255436|147314516|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.045|TWO_SIDED|95.0|1.0|1.6|||Fisher Exact||Numerator is Treatment Group (SMS reminders) and Denominator is Control Group (No SMS reminders)|||1.6|1.0|0.045
73891025|NCT01255436|147314517|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.014|TWO_SIDED|95.0|1.04|1.53|||Fisher Exact|||||1.53|1.04|0.014
73891026|NCT04816669|147314518|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.|Geometric mean ratio|0.68|||||TWO_SIDED|95.0|0.6|0.77|||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 lyophilized SDV - BNT162b2 frozen-liquid MDV and the corresponding CI (based on the Student t distribution).|||0.77|0.60|
73891027|NCT04816669|147314526|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67|Geometric mean ratio|1.14|||||TWO_SIDED|95.0|0.77|1.68|||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 frozen-liquid LNP - BNT162b2 frozen-liquid RTU and the corresponding CI (based on the Student t distribution).|||1.68|0.77|
73891028|NCT01229267|147314534|SUPERIORITY||Vaccine Efficacy|0.638|||||TWO_SIDED|95.0|0.484|0.746|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% confidence interval (CI) is \>0.25.||0.746|0.484|
73891029|NCT01229267|147314535|OTHER||Vaccine Efficacy|0.695|||||TWO_SIDED|95.0|0.49|0.818|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.818|0.490|
73891030|NCT01229267|147314536|OTHER||Vaccine Efficacy|0.735|||||TWO_SIDED|95.0|0.498|0.86|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.860|0.498|
73891031|NCT01229267|147314537|OTHER||Vaccine Efficacy|0.837|||||TWO_SIDED|95.0|0.446|0.952|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.952|0.446|
73891032|NCT01229267|147314538|OTHER||Risk Difference (RD)|0.2||||0.942|TWO_SIDED|95.0|-5.1|5.5|||Normal approximation||Miettinen \& Nurminen|||5.5|-5.1|0.942
73891033|NCT00826462|147314561|OTHER||||||<|0.01|||||||linear generalized estimating equations||||A linear GEE regression model adjusted for the significant covariates at p \< 0.05 from the univariate GEE logistic regression models calculated for success|||<0.01
73891034|NCT00826462|147314561|OTHER||||||<|0.01|||||||linear generalized estimating equations|||||||<0.01
73891035|NCT00826462|147314565|OTHER||||||||||||||||||linear generalized estimating equations (GEE) regression model adjusted for significant covariates; between groups estimated odds ratio (OR) for no pain on two isometric movements using logistic GEE regression model adjusted for significant covariates; 99 % confidence intervals|||
73891036|NCT01864603|147314580|OTHER||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.77|1.17||||||Comparison of Phase 1 arms||1.17|0.77|
73891037|NCT01864603|147314581|OTHER||Rate ratio|0.26|||||TWO_SIDED|95.0|0.09|0.75||||||||0.75|0.09|
73891038|NCT02446899|147314597|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.3||||0.0013|TWO_SIDED|95.0|6.3|26.3||Nominal p-value.|Cochran-Mantel-Haenszel|||||26.3|6.3|0.0013
73891039|NCT02446899|147314598|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.0022|TWO_SIDED|95.0|6.5|28.2||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||28.2|6.5|0.0022
73891040|NCT02446899|147314599|SUPERIORITY||Mean Difference (Final Values)|21.2||||0.0135|TWO_SIDED|95.0|6.8|35.7||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||35.7|6.8|0.0135
73891041|NCT02446899|147314600|SUPERIORITY||Mean Difference (Final Values)|24.0||||0.0392|TWO_SIDED|95.0|4.3|43.6||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||43.6|4.3|0.0392
73891042|NCT02446899|147314601|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.5469|TWO_SIDED|95.0|-10.6|20.0||Adjusted p-value|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||20.0|-10.6|0.5469
73891043|NCT02446899|147314602|SUPERIORITY||Rate Ratio|0.67||||0.0809|TWO_SIDED|95.0|0.48|0.94||Adjusted p-value.|Negative binomial regression|||Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>=10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]). The logarithm of the follow-up time is used as an offset variable.||0.94|0.48|0.0809
73891044|NCT04050202|147314607|OTHER||Mean Difference (Net)|8.45|||<|0.01|TWO_SIDED||||||t-test, 2 sided||The post-intervention score is subtracted from the baseline score.|||||<0.01
73891045|NCT04050202|147314608|OTHER||Mean Difference (Net)|13.97|||<|0.01|TWO_SIDED||||||t-test, 2 sided||The post-intervention score is subtracted from the baseline score|||||<0.01
73891046|NCT01499277|147314621|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in both MITT and CE Populations.|Risk Difference (RD)|-0.95|||||TWO_SIDED|95.0|-6.9|5.41||||RD is the difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.||5.41|-6.9|
73891047|NCT01499277|147314622|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in both MITT and CE Populations. If non-inferioirity was achieved then a test of superioirty was conducted if lower limit of 95% CI for the difference was \>0%.|Risk Difference (RD)|1.27|||||TWO_SIDED|95.0|-4.32|7.48||||RD is the difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.||7.48|-4.32|
73891048|NCT01499277|147314623|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.71|||||TWO_SIDED|95.0|-6.21|10.39||||RD is the difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||10.39|-6.21|
73891049|NCT01499277|147314624|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.77|||||TWO_SIDED|95.0|-2.11|12.86||||RD is the difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||12.86|-2.11|
73891050|NCT01499277|147314625|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.25|||||TWO_SIDED|95.0|-4.05|7.06||||RD is the difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||7.06|-4.05|
73891051|NCT01499277|147314626|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.92|||||TWO_SIDED|95.0|-2.19|8.73||||RD is the difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||8.73|-2.19|
73891052|NCT01499277|147314627|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.79|||||TWO_SIDED|95.0|-3.98|1.18||||RD is the difference in relapse rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||1.18|-3.98|
73891053|NCT01499277|147314628|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.86|||||TWO_SIDED|95.0|-6.34|3.15||||RD is the difference in success rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||3.15|-6.34|
73891054|NCT02974543|147314630|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73891055|NCT02974543|147314631|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73891056|NCT05814367|147314654|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used.|Least-square Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.025|0.014|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control|The sample size of 38 was calculated to provide at least 90% statistical power to test Non-inferiority of the Test lens compared to the Control lens using a paired t-test with a two-sided type I error rate of 5%.||0.014|-0.025|
73891057|NCT04730271|147314658|NON_INFERIORITY|Test of non-inferiority: Absolute value deviation from plan with ROBOTIC is less than it is with manual instruments (not using ROBOTIC) under a non-inferiority margin of 1.5 degrees|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
73891058|NCT04730271|147314659|SUPERIORITY|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
73891059|NCT04730271|147314660|SUPERIORITY|||||||0.0282|||||||t-test, 2 sided|||||||0.0282
73891060|NCT04730271|147314661|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||||||0.0004
73891061|NCT04730271|147314662|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73891062|NCT04730271|147314663|SUPERIORITY|||||||0.633|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 1 year of the procedure.||||0.6330
73891063|NCT04730271|147314663|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Comparison between the proportion of Robotic and Manual subjects who had a serious local adverse event within 1 year of the procedure.||||0.0400
73891064|NCT04730271|147314663|SUPERIORITY|||||||0.4079|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 90 days of the procedure.||||0.4079
73891065|NCT04730271|147314663|SUPERIORITY|||||||0.1262|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local serious adverse event within 90 days of the procedure.||||0.1262
73891066|NCT04730271|147314665|SUPERIORITY|||||||0.6662|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.6662
73891067|NCT04730271|147314665|SUPERIORITY|||||||0.8154|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.8154
73891068|NCT04730271|147314666|SUPERIORITY|||||||0.0165|||||||t-test, 2 sided|||Comparison of FJS at 12 weeks||||0.0165
73891069|NCT04730271|147314666|SUPERIORITY|||||||0.1331|||||||t-test, 2 sided|||Comparison of FJS at 1 year||||0.1331
73891070|NCT04730271|147314667|SUPERIORITY|||||||0.1596|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.1596
73891071|NCT04730271|147314667|SUPERIORITY|||||||0.6834|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.6834
73891072|NCT04730271|147314668|SUPERIORITY|||||||0.5675|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.5675
73891073|NCT04730271|147314668|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.9240
73891074|NCT04730271|147314669|SUPERIORITY|||||||0.4586|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.4586
73891075|NCT04730271|147314669|SUPERIORITY|||||||0.6951|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.6951
73891076|NCT04730271|147314670|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.8000
73891077|NCT04730271|147314670|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.9730
73891078|NCT04730271|147314671|SUPERIORITY|||||||0.4636|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.4636
73891079|NCT04730271|147314671|SUPERIORITY|||||||0.8088|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.8088
73891080|NCT04730271|147314672|SUPERIORITY|||||||0.4851|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 12 weeks||||0.4851
73891081|NCT04730271|147314672|SUPERIORITY|||||||0.6486|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 1 year||||0.6486
73891082|NCT04730271|147314673|SUPERIORITY|||||||0.8887|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline for Pain at rest between ROBOTIC and MANUAL at 1 year||||0.8887
73891083|NCT04730271|147314673|SUPERIORITY|||||||0.4007|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline for pain at rest between ROBOTIC and MANUAL at 12 weeks||||0.4007
73891084|NCT04730271|147314673|SUPERIORITY|||||||0.0074|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for pain at rest at 12 weeks||||0.0074
73891085|NCT04730271|147314673|SUPERIORITY|||||||0.0663|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain at rest at 1 year||||0.0663
73891086|NCT04730271|147314673|SUPERIORITY|||||||0.7096|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for Pain with Activity at 1 year||||0.7096
73891087|NCT04730271|147314673|SUPERIORITY|||||||0.5321|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for pain with activity at 12 weeks||||0.5321
73891088|NCT04730271|147314673|SUPERIORITY|||||||0.0709|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 12 weeks||||0.0709
73891089|NCT04730271|147314673|SUPERIORITY|||||||0.1274|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 1 year||||0.1274
73891090|NCT04730271|147314674|SUPERIORITY|||||||0.6745|||||||t-test, 2 sided|||Comparison between the accuracy achieved in the first 10 cases compared to the subsequent cases||||0.6745
73891091|NCT03682770|147314683|SUPERIORITY||Difference in percentage|20.23||||0.042|TWO_SIDED|95.0|1.266|39.189||The p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by screening peanut-specific IgE level and baseline body weight.|Cochran-Mantel-Haenszel||Difference in percentage derived by Mantel-Haenszel (MH) method|||39.189|1.266|0.0420
73891092|NCT03682770|147314684|SUPERIORITY||Least Square Mean Difference|0.67||||0.04|TWO_SIDED|95.0|0.031|1.305||P-value is based on treatment difference (dupilumab + AR101 vs placebo + AR101) of the LS mean change using analysis of covariance (ANCOVA) model.|ANCOVA|||||1.305|0.031|0.0400
73891093|NCT03682770|147314685|SUPERIORITY||Difference in percentage|11.91||||0.0806|TWO_SIDED|95.0|-3.612|27.44||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kilo allergy unit per liter \[kUA/L\] vs \>100 kUA/L) and body weight (\<30 kg, \>=30 and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||27.440|-3.612|0.0806
73891094|NCT03682770|147314687|SUPERIORITY||Difference in percentage|10.4||||0.353|TWO_SIDED|95.0|-11.668|32.474||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kUA/L vs \>100 kUA/L) and baseline body weight (\<30 kg, \>=30 kg and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||32.474|-11.668|0.3530
73891095|NCT03682770|147314688|SUPERIORITY||Least Square Mean Difference|0.37||||0.2628|TWO_SIDED|95.0|-0.281|1.029||P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.|ANCOVA|||||1.029|-0.281|0.2628
73891096|NCT03682770|147314689|SUPERIORITY||Difference in percentage|-2.36||||0.814|TWO_SIDED|95.0|-25.004|20.282||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kUA/L vs \>100 kUA/L) and baseline body weight (\<30 kg, \>=30 kg and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||20.282|-25.004|0.8140
73891097|NCT03682770|147314690|SUPERIORITY||Least Square Mean Difference|-0.05||||0.8805|TWO_SIDED|95.0|-0.699|0.599||P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.|ANCOVA|||||0.599|-0.699|0.8805
73891098|NCT03682770|147314692|SUPERIORITY||Difference percentage|-85.55|||<|0.0001|TWO_SIDED|95.0|-99.47|-73.91||P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate,- and stratification factors and the treatment as fixed factors.|ANCOVA||Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.|||-73.91|-99.47|<0.0001
73891099|NCT03682770|147314693|SUPERIORITY||Difference in percentage|-68.78|||<|0.0001|TWO_SIDED|95.0|-86.71|-56.4||P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate, and stratification factors and the treatment as fixed factors.|ANCOVA||Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.|||-56.40|-86.71|<0.0001
73891100|NCT02362282|147314694|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
73891101|NCT01166282|147314703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-51.17|||=|0.039|TWO_SIDED|95.0|-99.69|-2.66|||ANCOVA|||||-2.66|-99.69|=0.039
73891102|NCT01166282|147314704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.62|||=|0.382|TWO_SIDED|95.0|-5.32|2.08|||1-way ANOVA|||||2.08|-5.32|=0.382
73891103|NCT01166282|147314705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|||=|0.209|TWO_SIDED|95.0|-8.78|1.97|||1-way ANOVA|||||1.97|-8.78|=0.209
73891104|NCT01166282|147314706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.12|||=|0.509|TWO_SIDED|95.0|-4.49|2.26|||1-way ANOVA|||||2.26|-4.49|=0.509
73891105|NCT01166282|147314707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||=|0.514|TWO_SIDED|95.0|-18.5|40.5|||Fisher Exact|||||40.5|-18.5|=0.514
73891106|NCT01166282|147314708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.7|||=|0.111|TWO_SIDED|95.0|-2.0|57.5|||Fisher Exact|||||57.5|-2.0|=0.111
73891107|NCT01166282|147314709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.8|||=|0.031|TWO_SIDED|95.0|8.1|61.6|||Fisher Exact|||||61.6|8.1|=0.031
73891108|NCT02304367|147314725|OTHER|||||||0.0428|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in osteoid thickness is zero was tested using a t-test.||||0.0428
73891109|NCT02304367|147314726|OTHER|||||||0.977|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in OS/BS is zero was tested using a t-test.||||0.9770
73891110|NCT02304367|147314727|OTHER|||||||0.0858|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in OV/BV is zero was tested using a t-test.||||0.0858
73891111|NCT02304367|147314728|OTHER|||||||0.4077|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in Mlt is zero was tested using a t-test.||||0.4077
73891112|NCT02304367|147314735|OTHER|||||||0.016|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 24||||0.016
73891113|NCT02304367|147314735|OTHER|||||||0.03|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 48||||0.030
73891114|NCT02304367|147314735|OTHER|||||||0.259|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 96||||0.259
73891115|NCT02304367|147314735|OTHER|||||||0.346|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 144||||0.346
73891116|NCT02304367|147314735|OTHER|||||||0.213|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 168||||0.213
73891117|NCT02304367|147314735|OTHER|||||||0.873|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 192||||0.873
73891118|NCT02304367|147314735|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 216||||0.001
73891119|NCT02304367|147314735|OTHER|||||||0.04|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 240||||0.040
73891120|NCT02304367|147314736|OTHER||||||<|0.0001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 24||||<0.0001
73891121|NCT02304367|147314736|OTHER||||||<|0.0001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 48||||<0.0001
73891122|NCT02304367|147314736|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 96||||0.001
73891123|NCT02304367|147314736|OTHER|||||||0.007|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 144||||0.007
73891124|NCT02304367|147314736|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 168||||0.005
73891125|NCT02304367|147314736|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 192||||0.004
73891126|NCT02304367|147314736|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 216||||0.002
73891127|NCT02304367|147314736|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 240||||0.006
73891128|NCT02304367|147314737|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 24||||< 0.001
73891129|NCT02304367|147314737|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 48||||< 0.001
73891130|NCT02304367|147314737|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 96||||<0.001
73891131|NCT02304367|147314737|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 144||||< 0.001
73891132|NCT02304367|147314737|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 168||||< 0.001
73891133|NCT02304367|147314737|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 192||||< 0.001
73891134|NCT02304367|147314737|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 216||||< 0.001
73891135|NCT02304367|147314737|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 240||||< 0.001
73891136|NCT02304367|147314738|OTHER|||||||0.659|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 24||||0.659
73891137|NCT02304367|147314738|OTHER|||||||0.752|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 48||||0.752
73891138|NCT02304367|147314738|OTHER|||||||0.594|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 96||||0.594
73891139|NCT02304367|147314738|OTHER|||||||0.614|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 144||||0.614
73891140|NCT02304367|147314738|OTHER|||||||0.542|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 168||||0.542
73891141|NCT02304367|147314738|OTHER|||||||0.067|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 192||||0.067
73891142|NCT02304367|147314738|OTHER|||||||0.33|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 216||||0.330
73891143|NCT02304367|147314738|SUPERIORITY|||||||0.161|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 240||||0.161
73891144|NCT02304367|147314739|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 24||||< 0.001
73891145|NCT02304367|147314739|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 48||||< 0.001
73891146|NCT02304367|147314739|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 96||||0.001
73891147|NCT02304367|147314739|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 144||||< 0.001
73891148|NCT02304367|147314739|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 168||||< 0.001
73891149|NCT02304367|147314739|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 192||||< 0.001
73891150|NCT02304367|147314739|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 216||||< 0.001
73891151|NCT02304367|147314739|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 240||||< 0.001
73891152|NCT02304367|147314740|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 24||||< 0.001
73891153|NCT02304367|147314740|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 48||||< 0.001
73891154|NCT02304367|147314740|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 96||||0.002
73891155|NCT02304367|147314740|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 144||||< 0.001
73891156|NCT02304367|147314740|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 168||||< 0.001
73891157|NCT02304367|147314740|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 192||||< 0.001
73891158|NCT02304367|147314740|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 216||||< 0.001
73891159|NCT02304367|147314740|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 240||||< 0.001
73891160|NCT02304367|147314741|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 24||||< 0.001
73891161|NCT02304367|147314741|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 48||||< 0.001
73891162|NCT02304367|147314741|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 96||||< 0.001
73891163|NCT02304367|147314741|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 144||||< 0.001
73891164|NCT02304367|147314741|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 168||||< 0.001
73891165|NCT02304367|147314741|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 192||||< 0.001
73891166|NCT02304367|147314741|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 216||||< 0.001
73891167|NCT02304367|147314741|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 240||||< 0.001
73891168|NCT02304367|147314742|OTHER|||||||0.878|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 24||||0.878
73891169|NCT02304367|147314742|OTHER|||||||0.081|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 48||||0.081
73891170|NCT02304367|147314742|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 96||||0.001
73891171|NCT02304367|147314742|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 144||||< 0.001
73891172|NCT02304367|147314742|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 168||||< 0.001
73891173|NCT02304367|147314742|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 192||||< 0.001
73891174|NCT02304367|147314742|OTHER|||||||0.055|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 216||||0.055
73891175|NCT02304367|147314742|OTHER|||||||0.041|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 240||||0.041
73891176|NCT02304367|147314743|OTHER|||||||0.817|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 24||||0.817
73891177|NCT02304367|147314743|OTHER|||||||0.042|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 48||||0.042
73891178|NCT02304367|147314743|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 96||||< 0.001
73891179|NCT02304367|147314743|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 144||||< 0.001
73891180|NCT02304367|147314743|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 168||||< 0.001
73891181|NCT02304367|147314743|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 192||||< 0.001
73891182|NCT02304367|147314743|OTHER|||||||0.174|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 216||||0.174
73891183|NCT02304367|147314743|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 240||||< 0.001
73891184|NCT02304367|147314744|OTHER|||||||0.694|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 24||||0.694
73891185|NCT02304367|147314744|OTHER|||||||0.047|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 48||||0.047
73891186|NCT02304367|147314744|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 96||||< 0.001
73891187|NCT02304367|147314744|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 144||||< 0.001
73891188|NCT02304367|147314744|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 168||||< 0.001
73891189|NCT02304367|147314744|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 192||||< 0.001
73891190|NCT02304367|147314744|OTHER|||||||0.17|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 216||||0.170
73891191|NCT02304367|147314744|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 240||||< 0.001
73891192|NCT02304367|147314745|OTHER|||||||0.09|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 24||||0.090
73891193|NCT02304367|147314745|OTHER|||||||0.226|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 48||||0.226
73891194|NCT02304367|147314745|OTHER|||||||0.918|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 96||||0.918
73891195|NCT02304367|147314745|OTHER|||||||0.616|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 144||||0.616
73891196|NCT02304367|147314745|OTHER|||||||0.041|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 168||||0.041
73891197|NCT02304367|147314745|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 192||||0.002
73891198|NCT02304367|147314745|OTHER|||||||0.137|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 216||||0.137
73891199|NCT02304367|147314745|OTHER|||||||0.368|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 240||||0.368
73891200|NCT02304367|147314746|OTHER|||||||0.018|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 24||||0.018
73891201|NCT02304367|147314746|OTHER|||||||0.133|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 48||||0.133
73891202|NCT02304367|147314746|OTHER|||||||0.321|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 96||||0.321
73891203|NCT02304367|147314746|OTHER|||||||0.218|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 144||||0.218
73891204|NCT02304367|147314746|OTHER|||||||0.788|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 168||||0.788
73891205|NCT02304367|147314746|OTHER|||||||0.156|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 192||||0.156
73891206|NCT02304367|147314746|OTHER|||||||0.155|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 216||||0.155
73891207|NCT02304367|147314746|OTHER|||||||0.58|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 240||||0.580
73891208|NCT02304367|147314747|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 24||||0.002
73891209|NCT02304367|147314747|OTHER|||||||0.273|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 48||||0.273
73891210|NCT02304367|147314747|OTHER|||||||0.469|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 96||||0.469
73891211|NCT02304367|147314747|OTHER|||||||0.828|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 144||||0.828
73891212|NCT02304367|147314747|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 168||||< 0.001
73891213|NCT02304367|147314747|OTHER|||||||0.141|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 192||||0.141
73891214|NCT02304367|147314747|OTHER|||||||0.606|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 216||||0.606
73891215|NCT02304367|147314747|OTHER|||||||0.907|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 240||||0.907
73891216|NCT02304367|147314748|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 24||||0.001
73891217|NCT02304367|147314748|OTHER|||||||0.149|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 48||||0.149
73891218|NCT02304367|147314748|OTHER|||||||0.372|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 96||||0.372
73891219|NCT02304367|147314748|OTHER|||||||0.116|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 144||||0.116
73891220|NCT02304367|147314748|OTHER|||||||0.013|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 168||||0.013
73891221|NCT02304367|147314748|OTHER|||||||0.962|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 192||||0.962
73891222|NCT02304367|147314748|OTHER|||||||0.664|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 216||||0.664
73891223|NCT02304367|147314748|OTHER|||||||0.79|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 240||||0.790
73891224|NCT02304367|147314749|OTHER|||||||0.05|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 24||||0.050
73891225|NCT02304367|147314749|OTHER|||||||0.526|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 48||||0.526
73891226|NCT02304367|147314749|OTHER|||||||0.845|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 96||||0.845
73891227|NCT02304367|147314749|OTHER|||||||0.782|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 144||||0.782
73891228|NCT02304367|147314749|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 168||||0.020
73891229|NCT02304367|147314749|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 192||||0.005
73891230|NCT02304367|147314749|OTHER|||||||0.136|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 216||||0.136
73891231|NCT02304367|147314749|OTHER|||||||0.101|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 240||||0.101
73891232|NCT02304367|147314750|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 24||||< 0.001
73891233|NCT02304367|147314750|OTHER|||||||0.238|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 48||||0.238
73891234|NCT02304367|147314750|OTHER|||||||0.286|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 96||||0.286
73891235|NCT02304367|147314750|OTHER|||||||0.093|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 144||||0.093
73891236|NCT02304367|147314750|OTHER|||||||0.89|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 168||||0.890
73891237|NCT02304367|147314750|OTHER|||||||0.059|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 192||||0.059
73891238|NCT02304367|147314750|SUPERIORITY|||||||0.623||||||Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.|GEE model|||Week 216||||0.623
73891239|NCT02304367|147314750|OTHER|||||||0.411|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 240||||0.411
73891240|NCT02304367|147314751|OTHER|||||||0.8209|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.8209
73891241|NCT02304367|147314751|OTHER|||||||0.2851|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.2851
73891242|NCT02304367|147314751|OTHER|||||||0.6689|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.6689
73891243|NCT02304367|147314751|OTHER|||||||0.1612|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1612
73891244|NCT02304367|147314752|OTHER|||||||0.4093|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.4093
73891245|NCT02304367|147314752|OTHER|||||||0.572|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.5720
73891246|NCT02304367|147314752|OTHER|||||||0.3501|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.3501
73891247|NCT02304367|147314752|OTHER|||||||0.5172|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.5172
73891248|NCT02304367|147314753|OTHER|||||||0.0046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.||Week 24||||0.0046
73891249|NCT02304367|147314753|OTHER|||||||0.0012|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.||Week 48||||0.0012
73891250|NCT02304367|147314754|OTHER|||||||0.6475|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.6475
73891251|NCT02304367|147314754|OTHER|||||||0.5319|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.5319
73891252|NCT02304367|147314754|OTHER|||||||0.9206|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.9206
73891253|NCT02304367|147314754|OTHER|||||||0.153|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1530
73891254|NCT02304367|147314755|OTHER|||||||0.2125|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.2125
73891255|NCT02304367|147314755|OTHER|||||||0.1241|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1241
73891256|NCT02304367|147314756|OTHER|||||||0.41|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.410
73891257|NCT02304367|147314756|OTHER|||||||0.21|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.210
73891258|NCT02304367|147314756|OTHER|||||||0.06|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.060
73891259|NCT02304367|147314756|OTHER|||||||0.076|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.076
73891260|NCT02304367|147314756|OTHER|||||||0.171|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.171
73891261|NCT02304367|147314756|OTHER|||||||0.141|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.141
73891262|NCT02304367|147314756|OTHER|||||||0.263|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.263
73891263|NCT02304367|147314756|OTHER|||||||0.32|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.320
73891264|NCT02304367|147314757|OTHER|||||||0.407|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.407
73891265|NCT02304367|147314757|OTHER|||||||0.192|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.192
73891266|NCT02304367|147314757|OTHER|||||||0.106|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.106
73891267|NCT02304367|147314757|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.020
73891268|NCT02304367|147314757|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.002
73891269|NCT02304367|147314757|OTHER|||||||0.22|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.220
73891270|NCT02304367|147314757|OTHER|||||||0.23|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.230
73891271|NCT02304367|147314757|OTHER|||||||0.232|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.232
73891272|NCT02304367|147314758|OTHER|||||||0.082|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.082
73891273|NCT02304367|147314758|OTHER|||||||0.176|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.176
73891274|NCT02304367|147314758|OTHER|||||||0.047|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.047
73891275|NCT02304367|147314758|OTHER|||||||0.017|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.017
73891276|NCT02304367|147314758|OTHER|||||||0|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.000
73891277|NCT02304367|147314758|OTHER|||||||0.057|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.057
73891278|NCT02304367|147314758|OTHER|||||||0.071|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.071
73891279|NCT02304367|147314758|OTHER|||||||0.07|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.070
73891280|NCT02304367|147314759|OTHER|||||||0.014|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.014
73891281|NCT02304367|147314759|OTHER|||||||0.309|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.309
73891282|NCT02304367|147314759|OTHER|||||||0.036|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.036
73891283|NCT02304367|147314759|OTHER|||||||0.096|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.096
73891284|NCT02304367|147314759|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.005
73891285|NCT02304367|147314759|OTHER|||||||0.022|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.022
73891286|NCT02304367|147314759|OTHER|||||||0.022|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.022
73891287|NCT02304367|147314759|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.004
73891288|NCT02304367|147314760|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.005
73891289|NCT02304367|147314760|OTHER|||||||0.019|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.019
73891290|NCT02304367|147314760|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
73891291|NCT02304367|147314760|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.006
73891292|NCT02304367|147314760|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
73891293|NCT02304367|147314760|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||< 0.001
73891294|NCT02304367|147314760|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.002
73891295|NCT02304367|147314760|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.002
73891296|NCT02304367|147314761|OTHER|||||||0.016|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.016
73891297|NCT02304367|147314761|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.004
73891298|NCT02304367|147314761|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
73891299|NCT02304367|147314761|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
73891300|NCT02304367|147314761|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
73891301|NCT02304367|147314761|OTHER|||||||0.036|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.036
73891302|NCT02304367|147314761|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.008
73891303|NCT02304367|147314761|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.008
73891304|NCT02304367|147314762|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.006
73891305|NCT02304367|147314762|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.003
73891306|NCT02304367|147314762|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||<0.001
73891307|NCT02304367|147314762|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
73891308|NCT02304367|147314762|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
73891309|NCT02304367|147314762|SUPERIORITY|||||||0.007|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.007
73891310|NCT02304367|147314762|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.005
73891311|NCT02304367|147314762|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.006
73891312|NCT02304367|147314763|OTHER|||||||0.009|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.009
73891313|NCT02304367|147314763|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.020
73891314|NCT02304367|147314763|OTHER|||||||0.044|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.044
73891315|NCT02304367|147314763|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
73891316|NCT02304367|147314763|OTHER|||||||0.015|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.015
73891317|NCT02304367|147314763|OTHER|||||||0.125|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.125
73891318|NCT02304367|147314763|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.004
73891319|NCT02304367|147314763|OTHER|||||||0.018|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.018
73891320|NCT02304367|147314764|OTHER|||||||0.148|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.148
73891321|NCT02304367|147314764|OTHER|||||||0.295|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.295
73891322|NCT02304367|147314764|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.005
73891323|NCT02304367|147314764|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
73891324|NCT02304367|147314764|OTHER|||||||0.014|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.014
73891325|NCT02304367|147314764|OTHER|||||||0.14|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.140
73891326|NCT02304367|147314764|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||< 0.001
73891327|NCT02304367|147314764|OTHER|||||||0.142|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.142
73891328|NCT02304367|147314765|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.005
73891329|NCT02304367|147314765|OTHER|||||||0.077|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.077
73891330|NCT02304367|147314765|OTHER|||||||0.046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.046
73891331|NCT02304367|147314765|OTHER|||||||0.049|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.049
73891332|NCT02304367|147314765|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.003
73891333|NCT02304367|147314765|OTHER|||||||0.073|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.073
73891334|NCT02304367|147314765|OTHER|||||||0.109|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.109
73891335|NCT02304367|147314765|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.006
73891336|NCT02304367|147314766|OTHER|||||||0.328|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.328
73891337|NCT02304367|147314766|OTHER|||||||0.015|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.015
73891338|NCT02304367|147314766|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.020
73891339|NCT02304367|147314766|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.004
73891340|NCT02304367|147314766|OTHER|||||||0.021|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.021
73891341|NCT02304367|147314766|OTHER|||||||0.08|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.080
73891342|NCT02304367|147314766|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||< 0.001
73891343|NCT02304367|147314766|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.003
73891344|NCT02304367|147314767|OTHER|||||||0.207|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.207
73891345|NCT02304367|147314767|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.008
73891346|NCT02304367|147314767|OTHER|||||||0.598|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.598
73891347|NCT02304367|147314767|OTHER|||||||0.237|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.237
73891348|NCT02304367|147314767|OTHER|||||||0.899|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.899
73891349|NCT02304367|147314767|OTHER|||||||0.585|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.585
73891350|NCT02304367|147314767|OTHER|||||||0.461|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.461
73891351|NCT02304367|147314767|OTHER|||||||0.583|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.583
73891352|NCT02304367|147314768|OTHER|||||||0.654|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.654
73891353|NCT02304367|147314768|OTHER|||||||0.579|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.579
73891354|NCT02304367|147314768|OTHER|||||||0.123|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.123
73891355|NCT02304367|147314768|OTHER|||||||0.712|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.712
73891356|NCT02304367|147314768|OTHER|||||||0.258|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.258
73891357|NCT02304367|147314768|OTHER|||||||0.851|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.851
73891358|NCT02304367|147314768|OTHER|||||||0.849|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.849
73891359|NCT02304367|147314768|OTHER|||||||0.153|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.153
73891360|NCT02304367|147314769|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.002
73891361|NCT02304367|147314769|OTHER|||||||0.03|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.030
73891362|NCT02304367|147314769|OTHER|||||||0.011|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.011
73891363|NCT02304367|147314769|OTHER|||||||0.186|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.186
73891364|NCT02304367|147314769|OTHER|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.027
73891365|NCT02304367|147314769|OTHER|||||||0.33|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.330
73891366|NCT02304367|147314769|OTHER|||||||0.072|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.072
73891367|NCT02304367|147314769|OTHER|||||||0.045|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.045
73891368|NCT02304367|147314770|OTHER|||||||0.369|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.369
73891369|NCT02304367|147314770|OTHER|||||||0.026|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.026
73891370|NCT02304367|147314770|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
73891371|NCT02304367|147314770|OTHER|||||||0.235|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.235
73891372|NCT02304367|147314770|OTHER|||||||0.009|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.009
73891373|NCT02304367|147314770|OTHER|||||||0.278|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.278
73891374|NCT02304367|147314770|OTHER|||||||0.046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.046
73891375|NCT02304367|147314770|OTHER|||||||0.035|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.035
73891376|NCT02304367|147314771|OTHER|||||||0.442|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.442
73891377|NCT02304367|147314771|OTHER|||||||0.677|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.677
73891378|NCT02304367|147314771|OTHER|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.027
73891379|NCT02304367|147314771|OTHER|||||||0.42|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.420
73891380|NCT02304367|147314771|SUPERIORITY|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.027
73891381|NCT02304367|147314771|OTHER|||||||0.312|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.312
73891382|NCT02304367|147314771|OTHER|||||||0.249|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.249
73891383|NCT02304367|147314771|OTHER|||||||0.102|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.102
73891384|NCT02304367|147314772|OTHER|||||||0.856|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.856
73891385|NCT02304367|147314772|OTHER|||||||0.898|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.898
73891386|NCT02304367|147314772|OTHER|||||||0.785|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.785
73891387|NCT02304367|147314772|OTHER|||||||0.932|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.932
73891388|NCT02304367|147314772|OTHER|||||||0.545|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.545
73891389|NCT02304367|147314772|OTHER|||||||0.58|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.580
73891390|NCT02304367|147314772|OTHER|||||||0.462|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.462
73891391|NCT02304367|147314772|OTHER|||||||0.26|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.260
73891392|NCT01354314|147314806|SUPERIORITY|||||||0.893|||||||Regression, Linear|||||||0.893
73891393|NCT01354314|147314806|SUPERIORITY|||||||0.594|||||||Regression, Linear|||||||0.594
73891394|NCT01354314|147314806|SUPERIORITY|||||||0.712|||||||Regression, Linear|||||||0.712
73891395|NCT01354314|147314807|SUPERIORITY|||||||0.673|||||||Regression, Linear|||||||0.673
73891396|NCT01354314|147314807|SUPERIORITY|||||||0.153|||||||Regression, Linear|||||||0.153
73891397|NCT01354314|147314807|SUPERIORITY|||||||0.282|||||||Regression, Linear|||||||0.282
73891398|NCT01354314|147314808|SUPERIORITY|||||||0.327|||||||Regression, Linear|||||||0.327
73891399|NCT01354314|147314808|SUPERIORITY|||||||0.178|||||||Regression, Linear|||||||0.178
73891400|NCT01354314|147314808|SUPERIORITY|||||||0.48|||||||Regression, Linear|||||||0.480
73891401|NCT01354314|147314809|SUPERIORITY|||||||0.267|||||||Regression, Linear|||||||0.267
73891402|NCT01354314|147314809|SUPERIORITY|||||||0.368|||||||Regression, Linear|||||||0.368
73891403|NCT01354314|147314809|SUPERIORITY|||||||0.672|||||||Regression, Linear|||||||0.672
73891404|NCT01931566|147314883|OTHER|||||||0.023|||||||Regression, Cox|||||||0.023
73891405|NCT01931566|147314884|SUPERIORITY|||||||0.307|||||||Regression, Cox|||||||0.307
73891406|NCT04625101|147314911|SUPERIORITY|||||||0.4326|||||||ANCOVA|||||||0.4326
73891407|NCT02817464|147314922|OTHER||Geometric Mean Ratio|1.84|||||TWO_SIDED|90.0|1.44|2.36||||||||2.36|1.44|
73891408|NCT02817464|147314923|OTHER||Geometric Mean Ratio|0.66|||||TWO_SIDED|90.0|0.33|1.33||||||||1.33|0.33|
73891409|NCT02817464|147314925|OTHER||Geometric Mean Ratio|1.67|||||TWO_SIDED|90.0|1.33|2.09||||||||2.09|1.33|
73891410|NCT02817464|147314926|OTHER||Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.3|2.01||||||||2.01|1.30|
73891411|NCT02817464|147314927|OTHER||Geometric Mean Ratio|1.21|||||TWO_SIDED|90.0|1.04|1.4||||||||1.40|1.04|
73891412|NCT02817464|147314928|OTHER||Geometric Mean Ratio|0.51|||||TWO_SIDED|90.0|0.23|1.13||||||||1.13|0.23|
73891413|NCT02817464|147314930|OTHER|||||||0.0073|||||||Log Rank|||||||0.0073
73891414|NCT02605122|147314955|OTHER||Proportion experiencing TEAE or TESAE|34.3|||||TWO_SIDED|95.0|23.0|47.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||47|23|
73891415|NCT02605122|147314956|OTHER||Achievement of ECR|62.1|||||TWO_SIDED|95.0|49.0|74.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||74|49|
73891416|NCT02605122|147314957|OTHER||Achievement of Clinical Improvement|68.7|||||TWO_SIDED|95.0|58.0|78.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||78|58|
73891417|NCT02605122|147314958|OTHER||Achievement of Clinical Cure|62.0|||||TWO_SIDED|95.0|50.0|73.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson was used to determine confidence intervals.|Clopper-Pearson|||||73|50|
73891418|NCT00684060|147314959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|8.6|<|0.05|TWO_SIDED|95.0|-7.05|0.95||Threshold 0.05|t-test, 2 sided|No adjustment for multiple comparisons||Comparison of change in global LVEF in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||.95|-7.05|<0.05
73891419|NCT00684060|147314960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.05||95.0|0.08|1.17|||Fisher Exact|||comparison of the proportion of events in patients in the active group to those in patients in the control group||1.17|0.08|<0.05
73891420|NCT00684060|147314961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|17.2|<|0.05|TWO_SIDED|95.0|-9.3|6.8|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.||6.8|-9.3|<0.05
73891421|NCT00684060|147314962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|21.8|<|0.05|TWO_SIDED|95.0|-9.5|10.9|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.||10.9|-9.5|<0.05
73891422|NCT00684060|147314963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|14.2|<|0.05|TWO_SIDED|95.0|-4.1|9.2|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.||9.2|-4.1|<0.05
73891423|NCT00684060|147314964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|17.7|<|0.05||95.0|-9.9|6.9|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.||6.9|-9.9|<0.05
73891424|NCT00684060|147314965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|4.4|<|0.05|TWO_SIDED|95.0|-2.8|1.3||Unadjusted|t-test, 2 sided|||Comparison of change in infarct zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||1.3|-2.8|<0.05
73891425|NCT00684060|147314966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|6.9|<|0.05||95.0|-6.0|0.8|||t-test, 2 sided|||Comparison of change in border zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||0.8|-6.0|<0.05
73891426|NCT02641561|147314986|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
73891427|NCT00702715|147314987|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the estimated median treatment difference in recovery time must have fallen entirely within the pre-specified interval between -60 sec to +60 sec in order to claim equivalence|Median Difference (Final Values)|78.0|||||TWO_SIDED|95.0|36.0|143.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||143.0|36.0|
73891428|NCT00702715|147314988|NON_INFERIORITY_OR_EQUIVALENCE|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|68.0|||||TWO_SIDED|95.0|36.0|120.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||120.0|36.0|
73891429|NCT00702715|147314989|NON_INFERIORITY_OR_EQUIVALENCE|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|60.0|||||TWO_SIDED|95.0|31.0|103.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||103.0|31.0|
73891430|NCT03751657|147314990|OTHER||Treatment difference|-0.18||||0.0818|TWO_SIDED|95.0|-0.38|0.02|||Mixed Models Analysis|||The response and change from baseline in response after 26 weeks are analysed using a linear mixed model for repeated measures (MMRM) with an unstructured covariance matrix and treatment, region, use of DPP-4 inhibitor and visit as fixed factors, and baseline response as covariate. Furthermore, the model includes the interaction between visit and all explanatory variables.||0.02|-0.38|0.0818
73891431|NCT03751657|147315004|OTHER||Treatment difference|-1.97||||0.0818|TWO_SIDED|95.0|-4.19|0.25|||Mixed Models Analysis|||The response and change from baseline in response after 26 weeks are analysed using a linear MMRM with an unstructured covariance matrix and treatment, region, use of DPP-4 inhibitor and visit as fixed factors, and baseline response as covariate.Furthermore, the model includes the interaction between visit and all explanatory variables.||0.25|-4.19|0.0818
73891432|NCT04603027|147315006|SUPERIORITY||Posterior Mean difference|-5.99|||||TWO_SIDED|95.0|-20.28|7.12||||||||7.12|-20.28|
73891433|NCT04603027|147315006|SUPERIORITY||Posterior Mean difference|-8.35|||||TWO_SIDED|95.0|-22.07|5.04||||||||5.04|-22.07|
73891434|NCT04603027|147315006|SUPERIORITY||Posterior Mean difference|-9.1|||||TWO_SIDED|95.0|-23.22|4.65||||||||4.65|-23.22|
73891435|NCT04603027|147315007|SUPERIORITY||Posterior Mean difference|-2.6|||||TWO_SIDED|95.0|-13.91|9.9||||||||9.90|-13.91|
73891436|NCT04603027|147315007|SUPERIORITY||Posterior Mean difference|-3.33|||||TWO_SIDED|95.0|-15.21|8.52||||||||8.52|-15.21|
73891437|NCT04603027|147315007|SUPERIORITY||Posterior Mean difference|0.11|||||TWO_SIDED|95.0|-12.33|11.53||||||||11.53|-12.33|
73891438|NCT04603027|147315008|SUPERIORITY||Posterior Mean difference|-0.69|||||TWO_SIDED|95.0|-1.88|0.46||||||||0.46|-1.88|
73891439|NCT04603027|147315008|SUPERIORITY||Posterior Mean difference|-0.73|||||TWO_SIDED|95.0|-1.82|0.45||||||||0.45|-1.82|
73891440|NCT04603027|147315008|SUPERIORITY||Posterior Mean difference|-0.81|||||TWO_SIDED|95.0|-2.05|0.33||||||||0.33|-2.05|
73891441|NCT04603027|147315009|SUPERIORITY||Odds Ratio (OR)|2.64|||||TWO_SIDED|95.0|1.01|6.94||||||||6.94|1.01|
73891442|NCT04603027|147315009|SUPERIORITY||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|1.17|7.37||||||||7.37|1.17|
73891443|NCT04603027|147315009|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.63|4.7||||||||4.70|0.63|
73891444|NCT04603027|147315010|SUPERIORITY|||||||0.1|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.100
73891445|NCT04603027|147315010|SUPERIORITY|||||||0.034|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.034
73891446|NCT04603027|147315010|SUPERIORITY|||||||0.094|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.094
73891447|NCT04603027|147315014|SUPERIORITY||Posterior Mean Odds Ratio|2.14|||||TWO_SIDED|95.0|0.45|10.96||||||||10.96|0.45|
73891448|NCT04603027|147315014|SUPERIORITY||Posterior Mean Odds Ratio|2.02|||||TWO_SIDED|95.0|0.42|8.78||||||||8.78|0.42|
73891449|NCT04603027|147315014|SUPERIORITY||Posterior Mean Odds Ratio|2.12|||||TWO_SIDED|95.0|0.46|9.51||||||||9.51|0.46|
73891450|NCT04603027|147315015|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
73891451|NCT04603027|147315015|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
73891452|NCT04603027|147315015|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
73891453|NCT04603027|147315016|SUPERIORITY||Posterior Mean difference|-9.08|||||TWO_SIDED|95.0|-30.22|12.4||||||||12.40|-30.22|
73891454|NCT04603027|147315016|SUPERIORITY||Posterior Mean difference|2.99|||||TWO_SIDED|95.0|-23.41|18.15||||||||18.15|-23.41|
73891455|NCT04603027|147315016|SUPERIORITY||Posterior Mean difference|-17.1|||||TWO_SIDED|95.0|-38.29|3.25||||||||3.25|-38.29|
73891456|NCT04603027|147315017|SUPERIORITY||Posterior Mean difference|-2.66|||||TWO_SIDED|95.0|-6.79|1.52||||||||1.52|-6.79|
73891457|NCT04603027|147315017|SUPERIORITY||Posterior Mean difference|-0.83|||||TWO_SIDED|95.0|-4.7|3.16||||||||3.16|-4.70|
73891458|NCT04603027|147315017|SUPERIORITY||Posterior Mean difference|-3.53|||||TWO_SIDED|95.0|-7.49|0.63||||||||0.63|-7.49|
73891459|NCT04603027|147315018|SUPERIORITY||Posterior Mean difference|-9.08|||||TWO_SIDED|95.0|-30.22|12.4||||||||12.40|-30.22|
73891460|NCT04603027|147315018|SUPERIORITY||Posterior Mean difference|-2.99|||||TWO_SIDED|95.0|-23.41|18.15||||||||18.15|-23.41|
73891461|NCT04603027|147315018|SUPERIORITY||Posterior Mean difference|-17.1|||||TWO_SIDED|95.0|-38.29|3.25||||||||3.25|-38.29|
73891462|NCT04603027|147315019|SUPERIORITY||Posterior Mean difference|-2.66|||||TWO_SIDED|95.0|-6.79|1.52||||||||1.52|-6.79|
73891463|NCT04603027|147315019|SUPERIORITY||Posterior Mean difference|-0.83|||||TWO_SIDED|95.0|-4.7|3.16||||||||3.16|-4.70|
73891464|NCT04603027|147315019|SUPERIORITY||Posterior Mean difference|-3.53|||||TWO_SIDED|95.0|-7.49|0.63||||||||0.63|-7.49|
73891465|NCT04603027|147315020|SUPERIORITY||Posterior Mean difference|2.99|||||TWO_SIDED|95.0|-19.99|28.84||||||||28.84|-19.99|
73891466|NCT04603027|147315020|SUPERIORITY||Posterior Mean difference|-2.49|||||TWO_SIDED|95.0|-26.47|21.55||||||||21.55|-26.47|
73891467|NCT04603027|147315020|SUPERIORITY||Posterior Mean difference|13.36|||||TWO_SIDED|95.0|-12.03|36.92||||||||36.92|-12.03|
73891468|NCT04603027|147315021|SUPERIORITY||Posterior Mean difference|0.62|||||TWO_SIDED|95.0|-1.1|2.3||||||||2.30|-1.10|
73891469|NCT04603027|147315021|SUPERIORITY||Posterior Mean difference|-0.21|||||TWO_SIDED|95.0|-1.96|1.37||||||||1.37|-1.96|
73891470|NCT04603027|147315021|SUPERIORITY||Posterior Mean difference|-0.08|||||TWO_SIDED|95.0|-1.73|1.75||||||||1.75|-1.73|
73891471|NCT04603027|147315022|SUPERIORITY||Posterior Mean difference|13.71|||||TWO_SIDED|95.0|-50.62|73.35||||||||73.35|-50.62|
73891472|NCT04603027|147315022|SUPERIORITY||Posterior Mean difference|73.69|||||TWO_SIDED|95.0|21.69|126.92||||||||126.92|21.69|
73891473|NCT04603027|147315022|SUPERIORITY||Posterior Mean difference|8.41|||||TWO_SIDED|95.0|-44.58|56.81||||||||56.81|-44.58|
73891474|NCT04603027|147315023|SUPERIORITY||Posterior Mean difference|0.62|||||TWO_SIDED|95.0|-1.1|2.3||||||||2.30|-1.10|
73891475|NCT04603027|147315023|SUPERIORITY||Posterior Mean difference|-0.21|||||TWO_SIDED|95.0|-1.96|1.37||||||||1.37|-1.96|
73891476|NCT04603027|147315023|SUPERIORITY||Posterior Mean difference|-0.08|||||TWO_SIDED|95.0|-1.73|1.75||||||||1.75|-1.73|
73891477|NCT03284307|147315040|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.043||0.012|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Dexmedetomidine, Unconsciousness vs Disconnected Consciousness||||0.012
73891478|NCT03284307|147315040|SUPERIORITY||Slope|-0.238|STANDARD_ERROR_OF_MEAN|0.199||0.236|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Ketamine, Unconsciousness vs Disconnected Consciousness||||0.236
73891479|NCT03284307|147315040|SUPERIORITY||Slope|0.166|STANDARD_ERROR_OF_MEAN|0.12||0.174|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Propofol, Unconsciousness vs Disconnected Consciousness||||0.174
73891480|NCT03284307|147315040|SUPERIORITY||Slope|0.052|STANDARD_ERROR_OF_MEAN|0.111||0.64|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Sleep, Unconsciousness vs Disconnected Consciousness||||0.640
73891481|NCT03284307|147315042|SUPERIORITY|||||||0.134||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|3 degrees of freedom||NIH Toolbox Card Sorting Score||||0.134
73891482|NCT03284307|147315042|SUPERIORITY|||||||0.012||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|6 degrees of freedom||NIH Toolbox Card Sorting Score||||0.012
73891483|NCT03284307|147315042|SUPERIORITY|||||||0.487||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|1 degree of freedom||NIH Toolbox Card Sorting Score||||0.487
73891484|NCT03284307|147315042|SUPERIORITY|||||||0.046||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|3 degrees of freedom||NIH Toolbox Flanker Score||||0.046
73891485|NCT03284307|147315042|SUPERIORITY|||||||0.01||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|6 degrees of freedom||NIH Toolbox Flanker Score||||0.010
73891486|NCT03284307|147315042|SUPERIORITY|||||||0.356||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|||NIH Toolbox Flanker Score||||0.356
73891487|NCT03284307|147315043|SUPERIORITY||||||<|0.001||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|17 degrees of freedom||Predictive Coding Task Accuracy||||<0.001
73891488|NCT03284307|147315043|SUPERIORITY||||||<|0.001||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|14 degrees of freedom||Predictive Coding Task Accuracy||||<0.001
73891489|NCT03284307|147315043|SUPERIORITY|||||||0.067||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|4 degrees of freedom||Predictive Coding Task Accuracy||||0.067
73891490|NCT03284307|147315044|SUPERIORITY|||||||0.5||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|17 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.5
73891491|NCT03284307|147315044|SUPERIORITY|||||||0.37||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|11 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.37
73891492|NCT03284307|147315044|SUPERIORITY|||||||0.12||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|4 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.12
73891493|NCT02904954|147315137|SUPERIORITY||Risk Difference (RD)|46.6||||0.0001|TWO_SIDED|95.0|26.7|66.6||Testing at alpha = 0.05.|Fisher Exact|||Fisher's exact test performed to compare the MPR proportion between the two treatment arms. Null hypothesis is that there is no difference in the MPR proportion between the two arms.||66.6|26.7|0.0001
73891494|NCT02904954|147315138|SUPERIORITY|||||||0.89|||||||Log Rank|||Kaplan-Meier survival analysis comparing the two arms.||||0.89
73891495|NCT02904954|147315139|SUPERIORITY||Risk Difference (RD)|43.4||||0.0001|TWO_SIDED|95.0|24.4|62.3||Testing at alpha = 0.05.|Fisher Exact|||Fisher's exact test performed to compare the objective clinical response proportion between the two treatment arms. Null hypothesis is that there is no difference in the objective clinical response proportion between the two arms. Objective clinical response proportion is defined as the proportion of patients in each arm who have complete response or partial response.||62.3|24.4|0.0001
73891496|NCT02873702|147315148|NON_INFERIORITY|Non-inferiority to lansoprazole if the lower bound of confidence interval (CI) for the treatment difference is greater than -10%.|Difference in Percentage|-2.65|||||TWO_SIDED|95.0|-26.59|21.3||||||Healing Period: Dexlansoprazole 60 mg versus Healing Period: Lansoprazole 30 mg||21.30|-26.59|
73891497|NCT03249116|147315150|SUPERIORITY||F statistic|0.33||||0.723|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: self-reported anxiety between-subjects factors: condition, social anxiety within-subjects factor: time||||||.723
73891498|NCT03249116|147315151|SUPERIORITY||F statistic|1.34||||0.271|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: electrodermal activity between-subjects factors: condition, social anxiety within-subjects factor: time||||||.271
73891499|NCT03249116|147315152|SUPERIORITY||F statistic|0.45||||0.638|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: heart rate between-subjects factors: condition, social anxiety within-subjects factor: time||||||.638
73891500|NCT03249116|147315153|SUPERIORITY||F statistic|0.14||||0.868|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: number of errors between-subjects factors: condition, social anxiety||||||.868
73891501|NCT03249116|147315154|SUPERIORITY||F statistic|0.21||||0.809|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: lowest number reached/highest number of correct responses between-subjects factors: condition, social anxiety||||||.809
73891502|NCT02948634|147315155|SUPERIORITY|||||||0.43|||||||ANOVA|||||||0.43
73891503|NCT02948634|147315156|SUPERIORITY|||||||0.32|||||||ANOVA|||||||0.32
73891504|NCT02948634|147315157|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73891505|NCT00221117|147315164|OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||.015
73891506|NCT00221117|147315165|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||The subject's impairment and demographic characteristics were analyzed using descriptive statistics for parametric and nonparametric data. The baseline outcome data of the intervention and control groups were compared using Fisher exact test (for categorical variables) and Mann-Whitney U test (for continuous variables). Comparisons between the intervention and control groups were carried out using linear regression analysis adjusted for the baseline degree of disability (baseline AIS).||||0.05
73891507|NCT04954833|147315177|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR. A value of 0.05 logMAR is approximately 2.5 letters on the ETDRS chart.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|-0.01|0.02|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||0.02|-0.01|
73891508|NCT04954833|147315178|NON_INFERIORITY|A non-inferiority margin of 10% was used. A 10% of difference in the rate of lens fit acceptance is considered clinically significant.|Posterior mean difference of proportions|0.0|STANDARD_DEVIATION|0.0048|||TWO_SIDED|95.0|-0.009|0.01|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference between the Test and Control (Test - Control) was used to evaluate non-inferiority.|Interval presented is a 95% Credible interval|||0.010|-0.009|
73891509|NCT01262989|147315179|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.95||||||90.0|97.17|109.07|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||109.07|97.17|
73891510|NCT01262989|147315180|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.79||||||90.0|96.99|108.93|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||108.93|96.99|
73891511|NCT01262989|147315181|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.47||||||90.0|87.59|101.9|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||101.90|87.59|
73891512|NCT03599089|147315182|SUPERIORITY|||||||0.005|||||||ANOVA|||||||0.005
73891513|NCT03599089|147315183|SUPERIORITY|||||||0.0245|||||||Regression, Logistic|||||||0.0245
73891514|NCT03599089|147315184|SUPERIORITY|||||||0.0019|||||||ANOVA|||||||0.0019
73891515|NCT02289157|147315215|OTHER||Risk Ratio (RR)|0.9||||0.54|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|Ho: There is no difference between number of patients with wound complications between the study (icNPT) and comparison groups.||||1.4|0.5|0.54
73891516|NCT02289157|147315216|OTHER|||||||0.31|||||||Chi-squared|Pearson Chi-squared, df (3)||Ho: There is no difference between the types wound morbidity in the study (icNPT) and comparison groups.||||0.31
73891517|NCT02289157|147315217|OTHER|||||||0.54||||||Ho: There is no difference between initial length of stay between the study (icNPT) and comparison groups.|Wilcoxon (Mann-Whitney)|||||||0.54
73891518|NCT02289157|147315218|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in length of stay after readmission for wound morbidity between the study (icNPT) and comparison groups.||||0.41
73891519|NCT02289157|147315219|OTHER|||||||0.38|||||||Chi-squared|||Ho: There is no difference between the number of ER visits made per person between the study (icNPT) and comparison groups.||||0.38
73891520|NCT02289157|147315220|OTHER|||||||0.48||||||Ho: There is no difference between the number of visits made to the clinic for wound morbidity per patient between the study (icNPT) and comparison groups.|Chi-squared|||||||0.48
73891521|NCT02289157|147315221|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference between number of readmissions between the study (icNPT) and comparison groups.||||0.52
73891522|NCT02289157|147315221|OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the use of post operative antimicrobials between the the study (icNPT) and comparison groups.||||0.45
73891523|NCT02289157|147315221|OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the number of patients with Incision and Drainage and/or Extirpation between the study (icNPT) and comparison groups.||||0.44
73891524|NCT02289157|147315222|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: scheduled vs unscheduled cesarean section and icNPT vs Standard dressing||||||0.68||||||Ho: There is no difference between patients with wound morbidity that is significantly affected by the use of icNPT and whether or not the cesarean is scheduled or unscheduled.|Cochran-Mantel-Haenszel|||||||0.68
73891525|NCT02289157|147315223|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: pfannenstiel vs midline abdominal incision and icNPT vs Standard dressing||||||0.27|||||||Cochran-Mantel-Haenszel|||||||0.27
73891526|NCT02289157|147315224|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: ruptured vs unruptured membranes and icNPT vs Standard dressing||||||0.55|||||||Cochran-Mantel-Haenszel|||||||0.55
73891527|NCT02289157|147315225|OTHER|Cochran-Mantel-Haenzel test for interactions between labor vs no labor stratified by icNPT vs Standard dressing||||||0.49|||||||Cochran-Mantel-Haenszel|||||||0.49
73891528|NCT02289157|147315226|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing in wound morbidity||||||0.92|||||||Cochran-Mantel-Haenszel|||||||0.92
73891529|NCT02289157|147315227|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.||||||0.22|||||||Cochran-Mantel-Haenszel|||||||0.22
73891530|NCT02289157|147315228|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity||||||0.74|||||||Cochran-Mantel-Haenszel|||||||0.74
73891531|NCT00976560|147315239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.99|||TWO_SIDED|95.0|-2.54|1.35|||BMMRM|Bayesian Mixed Effects Model Repeated Measures (BMMRM)|Prior distribution of N(-4.1, 6.4009) incorporated into the posterior for the treatment difference at Week 6. The presented Confidence Interval is Highest Probability Density (HPD).||Posterior probability of the treatment difference being greater than 1.6 points in favor of GW856553 7.5mg BID as compared to placebo at Week 6 is 15.46 and for 0 is 72.98 and for 2 is 7.87.|1.35|-2.54|
73891532|NCT01600170|147315343|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.39
73891533|NCT01600170|147315344|SUPERIORITY||||||<|0.45||||||Threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||<0.45
73891534|NCT01600170|147315345|SUPERIORITY|||||||0.8||||||The threshold for statistical significance was p = 0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.80
73891535|NCT01600170|147315346|SUPERIORITY|||||||0.04||||||The threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.04
73891536|NCT01600170|147315347|SUPERIORITY|||||||0.15||||||The threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.15
73891537|NCT01600170|147315348|SUPERIORITY|||||||0.63||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.63
73891538|NCT01600170|147315349|SUPERIORITY|||||||0.035||||||Threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.035
73891539|NCT01600170|147315350|SUPERIORITY|||||||0.62||||||The threshold of statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.62
73891540|NCT01600170|147315351|SUPERIORITY|||||||0.99||||||The threshold of statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.99
73891541|NCT01077050|147315364|SUPERIORITY_OR_OTHER||Sensitivity to Melanoma|96.6|||||ONE_SIDED|95.0|94.2|||The point estimate of the observed sensitivity that is based on generalized linear mixed model is equal to that calculated in the usual manner.|Clopper-Pearson 1-sided||||||94.2|
73891542|NCT01077050|147315364|SUPERIORITY_OR_OTHER||Sensitivity to Basal Cell Carcinoma|100.0|||||TWO_SIDED|95.0|92.6|100.0|||Clopper-Pearson 2-sided|Point estimate of the observed sensitivity for Basal Cell Carcinoma||||100|92.6|
73891543|NCT01077050|147315364|SUPERIORITY_OR_OTHER||Observed sensitivity for squamous cell c|93.3|||||TWO_SIDED|95.0|68.1|99.8|||Clopper-Pearson 2-sided|Point estimate of the observed sensitivity for squamous cell carcinoma||||99.8|68.1|
73891544|NCT01077050|147315364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.0|||<|0.0001|TWO_SIDED|95.0|6.6|25.5|||Mixed Models Analysis|Note that calculating odds ratio adjusting for subjects having multiple lesions, yields similar result.||||25.5|6.6|<0.0001
73891545|NCT03894813|147315366|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
73891546|NCT03894813|147315367|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
73891547|NCT03894813|147315368|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
73891548|NCT03894813|147315369|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
73891549|NCT03894813|147315370|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
73891550|NCT01317277|147315453|SUPERIORITY|||||||0.68||||||In between-group analyses, overall MEMS adherence was defined as % of doses taken.|Wilcoxon (Mann-Whitney)|Non-parametric methods.||Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).||||0.68
73891551|NCT01317277|147315454|SUPERIORITY|||||||0.95||||||MEMS adherence based on dose timing was examined for between-group differences.|Wilcoxon (Mann-Whitney)|Non-parametric methods||Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).||||0.95
73891552|NCT01317277|147315455|SUPERIORITY|||||||0.05||||||Z = -1.97|Wilcoxon (Mann-Whitney)|Non-parametric methods; P-Value is calculated.||Text-reported METH use days||||0.05
73891553|NCT02688777|147315463|SUPERIORITY||Hazard Ratio, log|0.6|||||TWO_SIDED|||||||||||||
73891554|NCT02688777|147315464|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.37|TWO_SIDED|||||A priori threshold for significance is p \< 0.05.|t-test, 2 sided|||||||0.37
73891555|NCT02688777|147315465|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.02||0.13|TWO_SIDED|||||A priori threshold set for p \< 0.05|t-test, 2 sided|||||||0.13
73891556|NCT02688777|147315466|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.0||0.4|TWO_SIDED|||||A priori threshold p \< 0.05 for statistical significance.|t-test, 2 sided|||||||0.40
73891557|NCT02688777|147315467|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|3.4||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
73891558|NCT02688777|147315468|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.1||0.43|TWO_SIDED|||||A priori threshold set at p \< 0.05 for statistical significance.|t-test, 2 sided|||||||0.43
73891559|NCT02688777|147315469|SUPERIORITY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.8||0.02|TWO_SIDED|||||A prior threshold for significance set at p \< 0.05|t-test, 2 sided|||||||0.02
73891560|NCT02688777|147315470|SUPERIORITY||Mean Difference (Final Values)|13.95|STANDARD_ERROR_OF_MEAN|8.9||0.28|TWO_SIDED||||||t-test, 2 sided|||||||0.28
73891561|NCT02688777|147315471|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
73891562|NCT02688777|147315472|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
73891563|NCT02688777|147315473|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
73891564|NCT02688777|147315474|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
73891565|NCT02688777|147315475|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
73891566|NCT02549365|147315476|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|0.6|13.9|||||Incidence of laboratory confirmed influenza is compared between those vaccinated and household controls. VE will be calculated as 1 - RR with 95% confidence intervals using Poisson regression.|||13.9|0.6|
73891567|NCT00912795|147315479|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.62|6.3||||||||6.3|0.62|
73891568|NCT00912795|147315480|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3|||||TWO_SIDED|95.0|0.5|3.2||||||||3.2|0.50|
73891569|NCT00912795|147315481|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.5|||||TWO_SIDED|95.0|0.81|7.5||||||||7.5|0.81|
73891570|NCT00912795|147315482|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.62|6.3||||||||6.3|.62|
73891571|NCT01075685|147315508|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||Type 3 tests of fixed effects|||||||0.0279
73891572|NCT01075685|147315509|SUPERIORITY_OR_OTHER|||||||0.0189||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0189
73891573|NCT01075685|147315510|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Chi-squared|||||||0.009
73891574|NCT01075685|147315511|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||Chi-squared|||||||0.082
73891575|NCT00531661|147315512|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Negative Binomial Regression|||||||0.0002
73891576|NCT00531661|147315513|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implantation cases free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implantation cases was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) \> 80%"||||<0.0001
73891577|NCT00531661|147315514|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all patients implanted was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) \> 90%"||||<0.0001
73891578|NCT00531661|147315515|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||ANCOVA|||||||0.0077
73891579|NCT00531661|147315516|SUPERIORITY_OR_OTHER|||||||0.0292||95.0|||||Fisher Exact|||||||0.0292
73891580|NCT00531661|147315517|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0280
73891581|NCT00531661|147315518|SUPERIORITY_OR_OTHER|||||||0.0236||95.0|||||t-test, 2 sided|||||||0.0236
73891582|NCT00531661|147315519|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Negative Binomial Regression|||||||<0.0001
73891583|NCT00531661|147315520|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implanted patients was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) \> 80%"||||<0.0001
73891584|NCT00531661|147315521|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all implanted patients was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) \> 90%"||||<0.0001
73891585|NCT02858362|147315528|OTHER|Difference in least square means. All 23 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.023|||||TWO_SIDED|95.0|-0.002|0.048||||||Week 24 Change from Baseline||0.048|-0.002|
73891586|NCT02858362|147315528|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.006|||||TWO_SIDED|95.0|-0.03|0.042||||||Week 48 Change from Baseline||0.042|-0.03|
73891587|NCT02858362|147315529|OTHER|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-2.611|||||TWO_SIDED|95.0|-4.324|-0.898||||||Week 24 Change from Baseline||-0.898|-4.324|
73891588|NCT02858362|147315529|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|1.166|||||TWO_SIDED|95.0|-1.103|3.435||||||Week 48 Change from Baseline||3.435|-1.103|
73891589|NCT02858362|147315530|OTHER|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-1.837|||||TWO_SIDED|95.0|-3.989|0.315||||||Week 24 Change from Baseline||0.315|-3.989|
73891590|NCT02858362|147315530|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|0.096|4.324||||||Week 48 Change from Baseline||4.324|0.096|
73891591|NCT01301027|147315564|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||||||0.047
73891592|NCT01301027|147315565|SUPERIORITY_OR_OTHER|||||||0.059|||||||t-test, 2 sided|||||||0.059
73891593|NCT01301027|147315566|SUPERIORITY_OR_OTHER|||||||0.508|||||||t-test, 2 sided|||||||0.508
73891594|NCT01301027|147315567|SUPERIORITY_OR_OTHER|||||||0.984|||||||t-test, 2 sided|||||||0.984
73891595|NCT02023697|147315569|OTHER||Hazard Ratio (HR)|1.057||||0.7047|TWO_SIDED|80.0|0.878|1.272|||Log Rank||Arm B / Arm (A+C)|||1.272|0.878|0.7047
73891596|NCT02023697|147315571|OTHER||Hazard Ratio (HR)|1.26||||0.3134|TWO_SIDED|80.0|0.939|1.69|||Log Rank||Arm C /Arm A|||1.690|0.939|0.3134
73891597|NCT02023697|147315575|OTHER||Hazard Ratio (HR)|1.075||||0.6205|TWO_SIDED|80.0|0.892|1.297|||Log Rank||Arm B/Arm (A+C)|||1.297|0.892|0.6205
73891598|NCT02023697|147315577|OTHER||Hazard Ratio (HR)|0.999||||0.9958|TWO_SIDED|80.0|0.744|1.341|||Log Rank||Arm C/Arm A|||1.341|0.744|0.9958
73891599|NCT02023697|147315581|OTHER||Hazard Ratio (HR)|1.068||||0.7461|TWO_SIDED|80.0|0.823|1.385|||Log Rank||Arm B/Arm (A+C)|||1.385|0.823|0.7461
73891600|NCT02023697|147315583|OTHER||Hazard Ratio (HR)|1.549||||0.155|TWO_SIDED|80.0|1.041|2.306|||Log Rank||Arm C/Arm A|||2.306|1.041|0.1550
73891601|NCT02023697|147315587|OTHER||Hazard Ratio (HR)|0.969||||0.8284|TWO_SIDED|80.0|0.805|1.167|||Log Rank||Arm B/Arm (A+C)|||1.167|0.805|0.8284
73891602|NCT02023697|147315589|OTHER||Hazard Ratio (HR)|1.059||||0.7896|TWO_SIDED|80.0|0.804|1.396|||Log Rank||Arm C/Arm A|||1.396|0.804|0.7896
73891603|NCT02023697|147315593|OTHER||Hazard Ratio (HR)|0.986||||0.9274|TWO_SIDED|80.0|0.803|1.21|||Log Rank||Arm B/Arm (A+C)|||1.210|0.803|0.9274
73891604|NCT02023697|147315595|OTHER||Hazard Ratio (HR)|1.134||||0.5754|TWO_SIDED|80.0|0.85|1.514|||Log Rank||Arm C/Arm A|||1.514|0.850|0.5754
73891605|NCT02023697|147315601|OTHER||Hazard Ratio (HR)|0.898||||0.6214|TWO_SIDED|80.0|0.678|1.188|||Log Rank||Arm B/Arm (A+C)|||1.188|0.678|0.6214
73891606|NCT02023697|147315603|OTHER||Hazard Ratio (HR)|0.863||||0.7214|TWO_SIDED|80.0|0.505|1.475|||Log Rank||Arm C/Arm A|||1.475|0.505|0.7214
73891607|NCT01009619|147315614|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.||||<0.05
73891608|NCT01009619|147315615|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.||||<0.05
73891609|NCT00478023|147315647|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|18.1|||<|0.0001||95.0|10.9|25.3||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||25.3|10.9|<0.0001
73891610|NCT00478023|147315647|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|20.8|||<|0.0001||95.0|13.7|28.0||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||28.0|13.7|<0.0001
73891611|NCT00478023|147315647|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|23.3|||<|0.0001||95.0|16.3|30.4||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||30.4|16.3|<0.0001
73891612|NCT00478023|147315647|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|20.6|||<|0.0001||95.0|13.4|27.8||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.||27.8|13.4|<0.0001
73891613|NCT00478023|147315648|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|37.1|||<|0.0001||95.0|21.6|52.6||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||52.6|21.6|<0.0001
73891614|NCT00478023|147315648|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|44.0|||<|0.0001||95.0|28.6|59.5||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariates.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||59.5|28.6|<0.0001
73891615|NCT00478023|147315648|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|51.4|||<|0.0001||95.0|36.1|66.7||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA||Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||66.7|36.1|<0.0001
73891616|NCT00478023|147315648|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|46.9|||<|0.0001||95.0|31.4|62.4||No multiplicity adjustment.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as a covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.||62.4|31.4|<0.0001
73891617|NCT05019521|147315650|SUPERIORITY||Least square (LS) mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.0413||0.9205|TWO_SIDED|90.0|-0.01|0.126|||Mixed Models Analysis|||||0.126|-0.010|0.9205
73891618|NCT05019521|147315650|SUPERIORITY||LS mean difference|-0.016|STANDARD_ERROR_OF_MEAN|0.0425||0.9205|TWO_SIDED|90.0|-0.086|0.055|||Mixed Models Analysis|||||0.055|-0.086|0.9205
73891619|NCT05019521|147315650|SUPERIORITY||LS mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.0422||0.9205|TWO_SIDED|90.0|-0.033|0.106|||Mixed Models Analysis|||||0.106|-0.033|0.9205
73891620|NCT00611026|147315679|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||<0.0001
73891621|NCT00611026|147315679|SUPERIORITY_OR_OTHER|||||||0.0228|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0228
73891622|NCT00611026|147315679|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0072
73891623|NCT00611026|147315680|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0020
73891624|NCT00611026|147315680|SUPERIORITY_OR_OTHER|||||||0.0519|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0519
73891625|NCT00611026|147315680|SUPERIORITY_OR_OTHER|||||||0.1503|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.1503
73891626|NCT00611026|147315680|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
73891627|NCT00611026|147315680|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0002
73891628|NCT00611026|147315680|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Van Elteren's|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0130
73891629|NCT00611026|147315680|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
73891630|NCT00611026|147315680|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0021
73891631|NCT00611026|147315680|SUPERIORITY_OR_OTHER|||||||0.0525|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0525
73891632|NCT00611026|147315681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0161|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.||-0.1|-0.5|0.0161
73891633|NCT00611026|147315681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0944|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.||0.0|-0.4|0.0944
73891634|NCT00611026|147315681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3613|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.||0.1|-0.3|0.3613
73891635|NCT00611026|147315681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.||-0.4|-0.9|<0.0001
73891636|NCT00611026|147315681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0043|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.1|-0.6|0.0043
73891637|NCT00611026|147315681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0186|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.||-0.0|-0.5|0.0186
73891638|NCT00611026|147315681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.||-0.4|-0.9|<0.0001
73891639|NCT00611026|147315681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0407|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.||-0.0|-0.6|0.0407
73891640|NCT00611026|147315681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0016|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.||-0.1|-0.6|0.0016
73891641|NCT00611026|147315682|SUPERIORITY_OR_OTHER|||||||0.0217|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0217
73891642|NCT00611026|147315682|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
73891643|NCT00611026|147315682|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0020
73891644|NCT00611026|147315682|SUPERIORITY_OR_OTHER|||||||0.0217|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.||||0.0217
73891645|NCT00611026|147315682|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
73891646|NCT00611026|147315682|SUPERIORITY_OR_OTHER|||||||0.0421|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0421
73891647|NCT00611026|147315682|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.||||0.0023
73891648|NCT00611026|147315683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.3823|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.||0.1|-0.1|0.3823
73891649|NCT00611026|147315683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.4802|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.||0.1|-0.1|0.4802
73891650|NCT00611026|147315683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.0||0.8355|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.||0.1|-0.1|0.8355
73891651|NCT00611026|147315683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.0286|TWO_SIDED|95.0|-0.12|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.||-0.0|-0.12|0.0286
73891652|NCT00611026|147315683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0794|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.||0.0|-0.2|0.0794
73891653|NCT00611026|147315683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.0||0.5906|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.||0.1|-0.1|0.5906
73891654|NCT00611026|147315683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.0134|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.||-0.0|-0.3|0.0134
73891655|NCT00611026|147315683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.1759|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.||0.0|-0.2|0.1759
73891656|NCT00611026|147315683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.0||0.1661|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.||0.0|-0.2|0.1661
73891657|NCT00611026|147315684|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||0.0021
73891658|NCT00611026|147315684|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||0.0200
73891659|NCT00611026|147315685|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0006
73891660|NCT00611026|147315685|SUPERIORITY_OR_OTHER|||||||0.0202|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0202
73891661|NCT00611026|147315685|SUPERIORITY_OR_OTHER|||||||0.2126|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.2126
73891662|NCT00611026|147315685|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
73891663|NCT00611026|147315685|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0019
73891664|NCT00611026|147315685|SUPERIORITY_OR_OTHER|||||||0.0148|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0148
73891665|NCT00611026|147315686|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0012
73891666|NCT00611026|147315686|SUPERIORITY_OR_OTHER|||||||0.0205|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0205
73891667|NCT00611026|147315686|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
73891668|NCT00611026|147315686|SUPERIORITY_OR_OTHER|||||||0.0038|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0038
73891669|NCT00611026|147315686|SUPERIORITY_OR_OTHER|||||||0.0219|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0219
73891670|NCT00611026|147315686|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||0.0001
73891671|NCT00611026|147315686|SUPERIORITY_OR_OTHER|||||||0.0805|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0805
73891672|NCT00611026|147315686|SUPERIORITY_OR_OTHER|||||||0.0093|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0093
73891673|NCT00611026|147315687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0374|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||-0.0|-0.7|0.0374
73891674|NCT00611026|147315687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3161|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.2|-0.5|0.3161
73891675|NCT00611026|147315687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1817|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.1|-0.5|0.1817
73891676|NCT00611026|147315687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-0.8|-1.6|<0.0001
73891677|NCT00611026|147315687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0054|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.2|-1.0|0.0054
73891678|NCT00611026|147315687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0005|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.3|-0.9|0.0005
73891679|NCT00611026|147315687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-0.6|-1.5|<0.0001
73891680|NCT00611026|147315687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1467|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.1|-0.7|0.1467
73891681|NCT00611026|147315687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-0.4|-1.1|<0.0001
73891682|NCT00611026|147315688|SUPERIORITY_OR_OTHER|||||||0.0828|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0828
73891683|NCT00611026|147315688|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
73891684|NCT00611026|147315688|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0008
73891685|NCT00611026|147315688|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0022
73891686|NCT00611026|147315688|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
73891687|NCT00611026|147315688|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0008
73891688|NCT00611026|147315689|SUPERIORITY_OR_OTHER|||||||0.0576|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0576
73891689|NCT00611026|147315689|SUPERIORITY_OR_OTHER|||||||0.223|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.2230
73891690|NCT00611026|147315689|SUPERIORITY_OR_OTHER|||||||0.3555|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.3555
73891691|NCT00611026|147315689|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||<0.0001
73891692|NCT00611026|147315689|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0009
73891693|NCT00611026|147315689|SUPERIORITY_OR_OTHER|||||||0.0071|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0071
73891694|NCT00611026|147315689|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||<0.0001
73891695|NCT00611026|147315689|SUPERIORITY_OR_OTHER|||||||0.1764|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.1764
73891696|NCT00611026|147315689|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0001
73891697|NCT00611026|147315690|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
73891698|NCT00611026|147315690|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0003
73891699|NCT00611026|147315690|SUPERIORITY_OR_OTHER|||||||0.0302|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0302
73891700|NCT00611026|147315690|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
73891701|NCT00611026|147315690|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0007
73891702|NCT00611026|147315691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0701|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||0.0|-0.1|0.0701
73891703|NCT00611026|147315691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.4823|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.0|-0.1|0.4823
73891704|NCT00611026|147315691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.1702|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.0|-0.1|0.1702
73891705|NCT00611026|147315691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-0.1|-0.3|<0.0001
73891706|NCT00611026|147315691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0059|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.0|-0.2|0.0059
73891707|NCT00611026|147315691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0014|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.0|-0.2|0.0014
73891708|NCT00611026|147315691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-0.1|-0.3|<0.0001
73891709|NCT00611026|147315691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.311|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.0|-0.1|0.3110
73891710|NCT00611026|147315691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0004|TWO_SIDED|95.0|-0.2|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-0.1|-0.2|0.0004
73891711|NCT00611026|147315692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.0136|TWO_SIDED|95.0|-2.7|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||-0.3|-2.7|0.0136
73891712|NCT00611026|147315692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.6||0.1918|TWO_SIDED|95.0|-2.0|0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.4|-2.0|0.1918
73891713|NCT00611026|147315692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.1505|TWO_SIDED|95.0|-1.7|0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.3|-1.7|0.1505
73891714|NCT00611026|147315692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.2|-2.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-2.6|-5.2|<0.0001
73891715|NCT00611026|147315692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0034|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.7|-3.3|0.0034
73891716|NCT00611026|147315692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.5||0.0006|TWO_SIDED|95.0|-3.0|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.8|-3.0|0.0006
73891717|NCT00611026|147315692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.0|-2.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-2.3|-5.0|<0.0001
73891718|NCT00611026|147315692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.7||0.0859|TWO_SIDED|95.0|-2.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.2|-2.5|0.0859
73891719|NCT00611026|147315692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-1.4|-3.6|<0.0001
73891720|NCT00611026|147315693|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 1.||||0.0008
73891721|NCT00611026|147315693|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 1.||||0.0024
73891722|NCT00611026|147315693|SUPERIORITY_OR_OTHER|||||||0.6514|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 1.||||0.6514
73891723|NCT00611026|147315693|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 4.||||<0.0001
73891724|NCT00611026|147315693|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 4.||||0.0063
73891725|NCT00611026|147315693|SUPERIORITY_OR_OTHER|||||||0.0494|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 4.||||0.0494
73891726|NCT00611026|147315693|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 12.||||0.0003
73891727|NCT00611026|147315693|SUPERIORITY_OR_OTHER|||||||0.0991|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 12.||||0.0991
73891728|NCT00611026|147315693|SUPERIORITY_OR_OTHER|||||||0.0169|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 12.||||0.0169
73891729|NCT00611026|147315694|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0009
73891730|NCT00611026|147315694|SUPERIORITY_OR_OTHER|||||||0.0279|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0279
73891731|NCT00611026|147315694|SUPERIORITY_OR_OTHER|||||||0.2817|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||||0.2817
73891732|NCT00611026|147315694|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
73891733|NCT00611026|147315694|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0001
73891734|NCT00611026|147315694|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0177
73891735|NCT00611026|147315694|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
73891736|NCT00611026|147315694|SUPERIORITY_OR_OTHER|||||||0.0107|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0107
73891737|NCT00611026|147315694|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0005
73891738|NCT00611026|147315695|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0011
73891739|NCT00611026|147315695|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0072
73891740|NCT00611026|147315695|SUPERIORITY_OR_OTHER|||||||0.3713|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 1.||||0.3713
73891741|NCT00611026|147315695|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.||||0.0002
73891742|NCT00611026|147315695|SUPERIORITY_OR_OTHER|||||||0.1485|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.1485
73891743|NCT00611026|147315695|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.||||0.0040
73891744|NCT00611026|147315695|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
73891745|NCT00611026|147315695|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0060
73891746|NCT00611026|147315695|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.||||0.0016
73891747|NCT00611026|147315696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-9.5|-4.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-4.7|-9.5|<0.0001
73891748|NCT00611026|147315696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.2||0.0458|TWO_SIDED|95.0|-4.8|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||-0.0|-4.8|0.0458
73891749|NCT00611026|147315696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-6.6|-2.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-2.7|-6.6|<0.0001
73891750|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|3.4|7.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.||7.9|3.4|<0.0001
73891751|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.1||0.0429|TWO_SIDED|95.0|0.1|4.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Placebo: HRQL scale score total.||4.6|0.1|0.0429
73891752|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|0.9||0.0003|TWO_SIDED|95.0|1.5|5.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL scale score total.||5.2|1.5|0.0003
73891753|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|4.0|9.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo: HRQL concern domain.||9.2|4.0|<0.0001
73891754|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.3||0.0795|TWO_SIDED|95.0|-0.3|4.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Placebo vs Tolterodine ER: HRQL concern domain.||4.9|-0.3|0.0795
73891755|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|2.1|6.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL concern domain.||6.3|2.1|<0.0001
73891756|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.0001|TWO_SIDED|95.0|4.3|9.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.||9.6|4.3|<0.0001
73891757|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.3||0.0229|TWO_SIDED|95.0|0.4|5.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL coping domain.||5.7|0.4|0.0229
73891758|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|1.1||0.0004|TWO_SIDED|95.0|1.7|6.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL coping domain.||6.0|1.7|0.0004
73891759|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|1.2||0.0003|TWO_SIDED|95.0|2.0|6.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.||6.9|2.0|0.0003
73891760|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|1.2||0.0923|TWO_SIDED|95.0|-0.3|4.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL sleep domain.||4.5|-0.3|0.0923
73891761|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.0||0.018|TWO_SIDED|95.0|0.4|4.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL sleep domain.||4.4|0.4|0.0180
73891762|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.0||0.0011|TWO_SIDED|95.0|1.3|5.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.||5.1|1.3|0.0011
73891763|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.0||0.2208|TWO_SIDED|95.0|-0.7|3.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL social interaction domain.||3.1|-0.7|0.2208
73891764|NCT00611026|147315697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.8||0.0117|TWO_SIDED|95.0|0.4|3.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL social interaction domain.||3.5|0.4|0.0117
73891765|NCT04292899|147315745|SUPERIORITY||Odds Ratio (OR)|0.75||||0.1563|TWO_SIDED|95.0|0.507|1.115||P-value was calculated using a proportional odds model with treatment as the independent variable and baseline clinical status as a continuous covariate.|Proportional odds model|||||1.115|0.507|0.1563
73891766|NCT04292899|147315745|SUPERIORITY||Odds Ratio (OR)|0.67||||0.0368|TWO_SIDED|95.0|0.458|0.976||P-value was calculated using a proportional odds model with treatment as the independent variable.|Proportional odds model|||||0.976|0.458|0.0368
73891767|NCT04292899|147315746|SUPERIORITY||Difference in Percentages|1.3||||0.7678|TWO_SIDED|95.0|-7.4|10.0||P-value for comparison of the percentages between the two groups was calculated using the Cochran-Mantel-Haenszel test stratified on baseline clinical status.|Cochran-Mantel-Haenszel|||||10.0|-7.4|0.7678
73891768|NCT04674761|147315747|SUPERIORITY||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.277||0.0012|TWO_SIDED|95.0|-1.44|-0.33|||Mixed Models Analysis|||The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline score as a covariate, and baseline age stratification, baseline direct bilirubin, treatment group, time (in months), and treatment-by-time interaction as fixed effects. One-sided p-value was reported.||-0.33|-1.44|0.0012
73891769|NCT04674761|147315748|SUPERIORITY||LS mean difference|-112.74|STANDARD_ERROR_OF_MEAN|32.864||0.0006|TWO_SIDED|95.0|-178.78|-46.69|||Mixed Models Analysis|||The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline serum bile acid (sBA) concentration data as a covariate, and baseline age stratification, treatment group, visits (Weeks 4, 8, 12, 16, 20, 24), and treatment-by-visit interaction as fixed effects. The comparison of treatment difference in change from baseline to the average of Week 20 and Week 24 is estimated and tested using contrast. One-sided p-value was reported.||-46.69|-178.78|0.0006
73891770|NCT02469870|147315749|SUPERIORITY|||||||0.598|||||||ANCOVA|||To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.598
73891771|NCT02469870|147315750|SUPERIORITY|||||||0.81|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.81
73891772|NCT02469870|147315751|SUPERIORITY|||||||0.404|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.404
73891773|NCT02469870|147315752|SUPERIORITY|||||||0.246|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.246
73891774|NCT02469870|147315753|SUPERIORITY|||||||0.007|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.007
73891775|NCT02469870|147315754|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Two-sample t-test||||.045
73891776|NCT01209325|147315757|SUPERIORITY|||||||0.112||||||Two-sided p-value|Exact poisson test|||||||0.112
73891777|NCT01209325|147315757|SUPERIORITY|||||||0.447||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 0.0 events per 100 person years (PY) versus 3.4 events per 100 PY, respectively.||||0.447
73891778|NCT01209325|147315758|SUPERIORITY|||||||0.224||||||Two-sided p-value.|Exact poisson test|||||||0.224
73891779|NCT01209325|147315758|SUPERIORITY|One-sided p-value.||||||0.361|||||||Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 2.0 events per 100 PY, respectively.||||0.361
73891780|NCT01209325|147315759|SUPERIORITY|||||||0.079||||||Two-sided p-value.|Exact poisson test|||||||0.079
73891781|NCT01209325|147315759|SUPERIORITY|||||||0.35||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.8 events per 100 PY, respectively.||||0.350
73891782|NCT01209325|147315760|SUPERIORITY|||||||0.162|||||||Exact poisson test|||||||0.162
73891783|NCT01209325|147315760|SUPERIORITY|||||||0.49||||||One-sided p-value|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the Merck 020 per-protocol historical placebo group naive to HPV 18 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.0 events per 100 PY, respectively.||||0.490
73891784|NCT01209325|147315761|SUPERIORITY|||||||0.671||||||Two-sided p-value is comparing naive and prior exposure groups for HPV 6.|Exact Poisson calculation|||||||0.671
73891785|NCT01209325|147315761|SUPERIORITY|||||||0.312||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 1.8 events per 100 person years (PY) versus 4.5 events per 100 PY, respectively.||||0.312
73891786|NCT01209325|147315762|SUPERIORITY||||||>|0.999||||||Two-sided p-value.|Exact Poisson calculation|||||||>0.999
73891787|NCT01209325|147315762|SUPERIORITY|||||||0.209||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.7 events per 100 PY, respectively.||||0.209
73891788|NCT01209325|147315763|SUPERIORITY|||||||0.386||||||Two-sided p-value.|Exact Poisson calculation|||||||0.386
73891789|NCT01209325|147315763|SUPERIORITY|||||||0.305||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 2.9 events per 100 person years (PY) versus 4.9 events per 100 PY, respectively.||||0.305
73891790|NCT01209325|147315764|SUPERIORITY|||||||0.622||||||Two-sided p-value.|Exact Poisson calculation|||||||0.622
73891791|NCT01209325|147315764|SUPERIORITY|||||||0.15||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 18 (NCT00090285), 0.7 events per 100 person years (PY) versus 2.7 events per 100 PY, respectively.||||0.150
73891792|NCT01209325|147315765|SUPERIORITY|||||||0.064||||||Two-sided p-value.|Exact Poisson calculation|||||||0.064
73891793|NCT01209325|147315766|SUPERIORITY|||||||0.745||||||Two-sided test.|Exact Poisson calculation|||||||0.745
73891794|NCT01209325|147315767|SUPERIORITY|||||||0.014|||||||Exact Poisson calculation|||||||0.014
73891795|NCT01209325|147315768|SUPERIORITY|||||||0.166||||||Two-sided p-value.|Exact Poisson calculation|||||||0.166
73891796|NCT01209325|147315769|SUPERIORITY|||||||0.789||||||Two-sided p-value.|Exact Poisson calculation|||||||0.789
73891797|NCT01209325|147315770|SUPERIORITY|||||||0.809||||||Two-sided p-value.|0.809|||||||0.809
73891798|NCT01209325|147315771|SUPERIORITY|||||||0.422||||||Two-sided p-value.|Exact Poisson calculation|||||||0.422
73891799|NCT01209325|147315772|SUPERIORITY|||||||0.423||||||Two-sided p-value.|Exact Poisson calculation|||||||0.423
73891800|NCT05340478|147315801|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
73891801|NCT03523988|147315811|SUPERIORITY|||||||0.04||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.04
73891802|NCT03523988|147315811|SUPERIORITY|||||||0.63||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.63
73891803|NCT03523988|147315811|SUPERIORITY|||||||0.41||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.41
73891804|NCT03523988|147315812|SUPERIORITY|||||||0.65||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.65
73891805|NCT03523988|147315812|SUPERIORITY|||||||0.82||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.82
73891806|NCT03523988|147315812|SUPERIORITY|||||||0.69||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.69
73891807|NCT03523988|147315813|SUPERIORITY|||||||0.53||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.53
73891808|NCT03523988|147315813|SUPERIORITY|||||||0.31||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.31
73891809|NCT03523988|147315813|SUPERIORITY|||||||0.37||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.37
73891810|NCT02840461|147315890|EQUIVALENCE|Therapeutic equivalence of the Test product to the Reference product based on the primary endpoint was evaluated in the PP population. If the confidence interval is within 80-125% for the primary endpoint, then the Test and Reference treatments are considered therapeutically equivalent.|Mean Difference (Net)|103.51|||||TWO_SIDED|90.0|97.95|110.0||||||||110.00|97.95|
73891811|NCT02840461|147315890|SUPERIORITY||Mean Difference (Net)|-9.83||||0.0027|TWO_SIDED|95.0|-16.24|-3.42|||ANOVA|||||-3.42|-16.24|0.0027
73891812|NCT02840461|147315890|SUPERIORITY||Mean Difference (Net)|-9.83||||0.0028|TWO_SIDED|95.0|-16.25|-3.4|||ANOVA|||||-3.40|-16.25|0.0028
73891813|NCT02840461|147315891|EQUIVALENCE|If the 90% confidence interval (with Yates correction) for the difference between the proportion of patients in the Test and Reference groups considered to be a clinical success was contained within the pre-defined equivalence limits \[-20%, +20%\], the therapeutic equivalence of the Test to Reference product was considered supported.|Mean Difference (Net)|5.8|||||TWO_SIDED|90.0|-2.7|14.2||||||||14.2|-2.7|
73891814|NCT04672655|147315909|OTHER|||||||0.8875||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.8875
73891815|NCT04672655|147315910|OTHER|||||||0.4811||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.4811
73891816|NCT04672655|147315911|OTHER|||||||0.754||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.754
73891817|NCT04672655|147315912|OTHER|||||||0.0406||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.0406
73891818|NCT04672655|147315913|OTHER|||||||0.9032||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.9032
73891819|NCT00494676|147315914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2|||=|0.001|TWO_SIDED|95.0|1.8|21.0|||McNemar||The marginal odds ratio based on discordant pairs was computed.|The analysis used a McNemar test for data combined across both periods of the crossover. We estimated that 70% and 35% of participants would say yes to the real and sham prisms, respectively. For a 2-tailed test, the minimum sample size to detect a 35% difference in yes responses to real and sham prisms was 57 participants, assuming 30% overlap (30% said yes to both pairs of glasses), power of 90% and α of 1%. Assuming an attrition rate of 20%, we planned to enroll 68 participants.||21.0|1.8|= 0.001
73891820|NCT00494676|147315915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|2.6|=|0.09|TWO_SIDED|95.0|-0.1|1.3|||t-test, 2 sided|||Mobility improvement scores were normally distributed. A paired t-test was used to conduct a within-subjects comparison of the crossover differences in mobility scores between real and sham prism glasses. An alpha level of 5% was used to indicate statistical significance for secondary analyses||1.3|-0.1|= 0.09
73891821|NCT00494676|147315916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|2.7|=|0.002|TWO_SIDED|95.0|0.7|3.0|||t-test, 2 sided|||||3.0|0.7|= 0.002
73891822|NCT00494676|147315917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|2.1|=|0.21|TWO_SIDED|95.0|-1.2|0.3|||t-test, 2 sided|||||0.3|-1.2|= 0.21
73891823|NCT05767749|147315920|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.93|TWO_SIDED|95.0|-12.8|14.0|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Ropivacaine) minus (Lidocaine + epinephrine vs Bupivacaine)|||14.0|-12.8|0.93
73891824|NCT05767749|147315920|SUPERIORITY||Mean Difference (Final Values)|3.73||||0.54|TWO_SIDED|95.0|-8.3|15.8|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Ropivacaine) minus (Ropivacaine vs Bupivacaine)|||15.8|-8.3|0.54
73891825|NCT05767749|147315920|SUPERIORITY||Mean Difference (Final Values)|3.12||||0.6|TWO_SIDED|95.0|-8.7|15.0|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Bupivacaine) minus (Ropivacaine vs Bupivacaine)|||15.0|-8.7|0.60
73891826|NCT01243580|147315930|EQUIVALENCE|Comparing Ortho-Cyclen to Ag200-15|||||<|0.0001|||||||ANOVA|||||||<0.0001
73891827|NCT01243580|147315931|EQUIVALENCE|Comparison of AG200-15 and Ortho-Cyclen|||||<|0.0001|||||||ANOVA|||||||<0.0001
73891828|NCT01243580|147315932|EQUIVALENCE|Comparison of AG200-15 and Ortho-Cyclen||||||0.0001|||||||ANOVA|||||||0.0001
73891829|NCT01243580|147315933|EQUIVALENCE|Comparison of Ortho-Cylen and AG200-15||||||0.0532|||||||ANOVA|||||||0.0532
73891830|NCT01243580|147315934|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0009|||||||ANOVA|||||||0.0009
73891831|NCT01243580|147315935|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0167|||||||ANOVA|||||||0.0167
73891832|NCT01243580|147315936|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0007|||||||ANOVA|||||||0.0007
73891833|NCT01243580|147315937|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0175|||||||ANOVA|||||||0.0175
73891834|NCT01243580|147315938|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0001|||||||ANOVA|||||||0.0001
73891835|NCT01243580|147315939|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0532|||||||ANOVA|||||||0.0532
73891836|NCT04939415|147315948|SUPERIORITY||ratio of frequencies|0.0||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
73891837|NCT04939415|147315949|SUPERIORITY||ratio of frequencies|1.023||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
73891838|NCT04939415|147315951|SUPERIORITY||ratio of frequencies|1.073||||0.488|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.488
73891839|NCT04939415|147315952|SUPERIORITY||ratio of frequencies|2.1||||0.488|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.488
73891840|NCT04939415|147315954|SUPERIORITY||ratio of frequencies|3.243||||0.231|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.231
73891841|NCT04939415|147315955|SUPERIORITY||ratio of frequencies|0.034||||1|TWO_SIDED||||||Chi-squared, Corrected|The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.||||||1.000
73891842|NCT04939415|147315956|OTHER||ratio of frequencies|0.083||||1|TWO_SIDED||||||Chi-squared, Corrected|The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.||||||1.000
73891843|NCT04939415|147315958|SUPERIORITY||ratio of frequencies|1.213||||0.462|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.462
73891844|NCT04939415|147315959|SUPERIORITY||ratio of frequencies|0.153||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
73891845|NCT04939415|147315960|SUPERIORITY||F value|0.185||||0.668|TWO_SIDED||||||Mixed Models Analysis|Group by Day interaction||||||0.668
73891846|NCT04939415|147315961|SUPERIORITY||F value|0.032||||0.86|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||0.860
73891847|NCT04939415|147315962|SUPERIORITY||F value|0.035||||0.853|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||0.853
73891848|NCT04939415|147315963|SUPERIORITY||F value|0.0||||0.995|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.995
73891849|NCT04939415|147315964|SUPERIORITY||F value|1.27||||0.266|TWO_SIDED||||||Mixed Models Analysis|||||||0.266
73891850|NCT04939415|147315965|SUPERIORITY||F value|4.533||||0.039|TWO_SIDED||||||Mixed Models Analysis||group by day interaction is reported.|||||0.039
73891851|NCT04939415|147315965|SUPERIORITY||F Ratio|13.897|||<|0.001|TWO_SIDED||||||ANOVA|Degrees of freedom: 1,23||day 0 to day 14 for the mQFPD group were examined.||||<0.001
73891852|NCT04939415|147315965|SUPERIORITY||F ratio|0.41||||0.529|TWO_SIDED||||||ANOVA|degrees of freedom: 1,20||day 0 to day 14 for the Placebo Group were examined.||||0.529
73891853|NCT04939415|147315966|SUPERIORITY||ratio of frequencies|0.14||||0.71|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.710
73891854|NCT04939415|147315967|SUPERIORITY||F value|2.855||||0.099|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.099
73891855|NCT04939415|147315968|SUPERIORITY||F value|1.497||||0.228|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.228
73891856|NCT04939415|147315969|SUPERIORITY||F value|2.537||||0.119|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.119
73891857|NCT04939415|147315970|SUPERIORITY||F value|0.219||||0.643|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.643
73891858|NCT04939415|147315971|SUPERIORITY||F value|0.054||||0.817|TWO_SIDED||||||Mixed Models Analysis|||||||0.817
73891859|NCT04939415|147315972|SUPERIORITY||F value|0.315||||0.578|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.578
73891860|NCT04939415|147315973|SUPERIORITY||F value|0.215||||0.643|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||.643
73891861|NCT04939415|147315974|SUPERIORITY||F value|1.987||||0.159|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||.159
73891862|NCT00092443|147315992|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|72.5|||<|0.001||95.0|50.6|85.6|||Exact Binomial Test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|||85.6|50.6|<0.001
73891863|NCT00092443|147315993|SUPERIORITY_OR_OTHER||Percent of Participants|56.7||||||95.0|44.0|66.8||||||||66.8|44.0|
73891864|NCT00092443|147315993|SUPERIORITY_OR_OTHER||Percent of Participants|2.7||||||95.0|0.3|9.5||||||||9.5|0.3|
73891865|NCT00092443|147315993|SUPERIORITY_OR_OTHER||Percent of Participants|14.5||||||95.0|6.9|25.8||||||||25.8|6.9|
73891866|NCT00092443|147315993|SUPERIORITY_OR_OTHER||Percent of Participants|0.0||||||95.0|0.0|5.1||||||||5.1|0.0|
73891867|NCT00092443|147315993|SUPERIORITY_OR_OTHER||Percent of Participants|9.0||||||95.0|3.4|18.5||||||||18.5|3.4|
73891868|NCT00092443|147315993|SUPERIORITY_OR_OTHER||Percent of Participants|0.0||||||95.0|0.0|4.8||||||||4.8|0.0|
73891869|NCT00092443|147315993|SUPERIORITY_OR_OTHER||Percent of Participants|39.7||||||95.0|27.6|52.8||||||||52.8|27.6|
73891870|NCT00092443|147315993|SUPERIORITY_OR_OTHER||Percent of Participants|1.4||||||95.0|0.0|7.7||||||||7.7|0.0|
73891871|NCT00092443|147315993|SUPERIORITY_OR_OTHER||Percent of Participants|24.6||||||95.0|14.5|37.3||||||||37.3|14.5|
73891872|NCT00092443|147315993|SUPERIORITY_OR_OTHER||Percent of Participants|2.9||||||95.0|0.4|10.1||||||||10.1|0.4|
73891873|NCT04717336|147316022|SUPERIORITY||Mean of Paired Differences|0.002||||0.98|TWO_SIDED|95.0|-0.22|0.23|||Paired T-Test|A paired t-test was applied across both periods because this is a cross-over study where each participant serves at their own control.||The aim of this analysis is to test whether there is a statistically significant difference in Pulse Wave Velocity when participants are on sodium chloride vs. placebo, regardless of period.||0.23|-0.22|0.98
73891874|NCT01500720|147316030|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.169|||<|0.0001|TWO_SIDED|95.0|1.563|3.01||P-value was calculated from stratified two-sided log-rank test, stratifying for brain metastases and lactate dehydrogenase (LDH) level at the time of randomization.|Stratified Two-Sided Log-Rank Test||Hazard ratio was estimated using a COX Proportional Hazards regression model, stratifying for brain metastases and LDH level at the time of randomization.|||3.01|1.563|<0.0001
73891875|NCT00806819|147316036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0435|TWO_SIDED|95.0|0.7|0.99|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||0.99|0.70|0.0435
73891876|NCT00806819|147316037|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.894|TWO_SIDED|95.0|0.85|1.21|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.21|0.85|0.8940
73891877|NCT00806819|147316038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0506|TWO_SIDED|95.0|0.7|1.0|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.00|0.70|0.0506
73891878|NCT00806819|147316039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0865|TWO_SIDED|95.0|0.73|1.02|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.02|0.73|0.0865
73891879|NCT00806819|147316040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7279|TWO_SIDED|95.0|0.65|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||1.85|0.65|0.7279
73891880|NCT00806819|147316040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.518|TWO_SIDED|95.0|0.75|1.76||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment||1.76|0.75|0.5180
73891881|NCT00806819|147316043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.0387|TWO_SIDED|95.0|1.02|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||1.85|1.02|0.0387
73891882|NCT00806819|147316043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.1071|TWO_SIDED|95.0|0.95|1.75||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on investigator's assessment||1.75|0.95|0.1071
73891883|NCT00806819|147316045|SUPERIORITY_OR_OTHER|||||||0.1558|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review||||0.1558
73891884|NCT00806819|147316045|SUPERIORITY_OR_OTHER|||||||0.0565|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment||||0.0565
73891885|NCT00806819|147316046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5068|TWO_SIDED|95.0|0.74|1.16|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.16|0.74|0.5068
73891886|NCT00806819|147316047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1181|TWO_SIDED|95.0|0.66|1.05|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.05|0.66|0.1181
73891887|NCT00806819|147316047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.4264|TWO_SIDED|95.0|0.77|1.12|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.12|0.77|0.4264
73891888|NCT00806819|147316047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.8929|TWO_SIDED|95.0|0.84|1.23|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>= 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.23|0.84|0.8929
73891889|NCT04901715|147316091|OTHER|||||||0.002|||||||ANOVA|||||||0.002
73891890|NCT04901715|147316091|OTHER|||||||0.054|||||||ANOVA|||||||0.054
73891891|NCT04901715|147316091|OTHER|||||||0.27|||||||ANOVA|||||||0.27
73891892|NCT04901715|147316092|OTHER|||||||0.014|||||||ANOVA|||||||0.014
73891893|NCT04901715|147316092|OTHER|||||||0.066|||||||ANOVA|||||||0.066
73891894|NCT04901715|147316092|OTHER|||||||0.58|||||||ANOVA|||||||0.58
73891895|NCT03843541|147316101|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_DEVIATION|0.763|<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||<0.001
73891896|NCT03843541|147316102|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_DEVIATION|0.783||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||0.002
73891897|NCT03843541|147316103|SUPERIORITY|||||||0.239|||||||Stratified Mann-Whitney U Statistic|||||||0.239
73891898|NCT03843541|147316104|SUPERIORITY|||||||0.037|||||||Stratified Mann-Whitney U Statistic|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||0.037
73891899|NCT03843541|147316105|SUPERIORITY|||||||0.093|||||||Stratified Mann Whitney U Statistic|||||||0.093
73891900|NCT03843541|147316105|SUPERIORITY|||||||0.118|||||||Stratified Mann Whitney U Statistic|||||||0.118
73891901|NCT03843541|147316106|SUPERIORITY|||||||0.022|||||||Stratified Mann Whitney U Statistic|||||||0.022
73891902|NCT03843541|147316106|SUPERIORITY|||||||0.11|||||||Stratified Mann Whitney U Statistic|||||||0.110
73891903|NCT03843541|147316107|SUPERIORITY|||||||0.022|||||||Stratified Mann Whitney U Statistic|||||||0.022
73891904|NCT03843541|147316107|SUPERIORITY|||||||0.402|||||||Stratified Mann Whitney U Statistic|||||||0.402
73891905|NCT03843541|147316108|NON_INFERIORITY|Non-inferiority was declared if the one-sided confidence interval was within the interval.|Probability scale treatment difference|0.5||||0.002|TWO_SIDED|97.5|0.43|1.0|||Modified Mann-Whitney U Statistic||The point estimates of treatment differences in probability scale together with associated one-side confidence interval (97.5% or 98.75%) were computed according to Hochberg if both superiority contrasts were found statistically significant.|||1.00|0.43|0.002
73891906|NCT03843541|147316109|NON_INFERIORITY|Non-inferiority was declared if the one-sided confidence interval was within the interval.|Probability scale treatment difference|0.5|||<|0.001|TWO_SIDED|98.75|0.45|1.0|||Modified Mann-Whitney U Statistic||"The point estimates of treatment differences in probability scale together with associated one-side confidence interval (97.5% or 98.75%) were computed according to Hochberg if both superiority contrasts were found statistically significant.~."|||1.00|0.45|<0.001
73891907|NCT03843541|147316110|SUPERIORITY|||||||0.356|||||||Modified Mann-Whitney U Statistic|||||||0.356
73891908|NCT03843541|147316110|SUPERIORITY|||||||0.007|||||||Modified Mann-Whitney U Statistic|||||||0.007
73891909|NCT03843541|147316111|SUPERIORITY|||||||0.38|||||||Modified Mann-Whitney U Statistic|||||||0.380
73891910|NCT03843541|147316111|SUPERIORITY|||||||0.018|||||||Modified Mann-Whitney U Statistic|||||||0.018
73891911|NCT03843541|147316112|SUPERIORITY|||||||0.366|||||||Modified Mann-Whitney U Statistic|||||||0.366
73891912|NCT03843541|147316112|SUPERIORITY|||||||0.027|||||||Modified Mann-Whitney U Statistic|||||||0.027
73891913|NCT03843541|147316113|SUPERIORITY|||||||0.052|||||||Modified Mann-Whitney U Statistic|||||||0.052
73891914|NCT03843541|147316113|SUPERIORITY|||||||0.058|||||||Modified Mann-Whitney U Statistic|||||||0.058
73891915|NCT03843541|147316114|SUPERIORITY|||||||0.309|||||||Modified Mann-Whitney U Statistic|||||||0.309
73891916|NCT03843541|147316114|SUPERIORITY|||||||0.006|||||||Modified Mann-Whitney U Statistic|||||||0.006
73891917|NCT05307692|147316121|SUPERIORITY||Difference of Least Square (LS) Means|-1.5|STANDARD_ERROR_OF_MEAN|1.47||0.308|TWO_SIDED|80.0|-3.41|0.39|||Mixed model repeated measures|||||0.39|-3.41|0.308
73891918|NCT05307692|147316122|SUPERIORITY||Difference of Least Square (LS) Means|-1.5|STANDARD_ERROR_OF_MEAN|1.42||0.282|TWO_SIDED|80.0|-3.33|0.29|||Mixed model repeated measures|||||0.29|-3.33|0.282
73891919|NCT02003924|147316142|SUPERIORITY||Hazard Ratio (HR)|0.292|||<|0.0001|TWO_SIDED|95.0|0.241|0.352||P-value was based on stratified log-rank test by prostate-specific antigen (PSA) doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no). Threshold for significance at 0.05 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||0.352|0.241|<0.0001
73891920|NCT02003924|147316143|SUPERIORITY||Hazard Ratio (HR)|0.066|||<|0.0001|TWO_SIDED|95.0|0.054|0.081||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the primary endpoint was statistically significant.||0.081|0.054|<0.0001
73891921|NCT02003924|147316144|SUPERIORITY||Hazard Ratio (HR)|0.208|||<|0.0001|TWO_SIDED|95.0|0.168|0.258||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the previous endpoint was statistically significant.||0.258|0.168|<0.0001
73891922|NCT02003924|147316145|SUPERIORITY||Hazard Ratio (HR)|0.734||||0.0011|TWO_SIDED|95.0|0.608|0.885||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per interactive voice/web recognition system (IXRS).|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain family-wise 2-sided type I error rate at 0.05,parallel testing strategy between OS(with allocated type I error rate 0.03)and remaining key secondary endpoints(time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02)was performed.OS tested at error rate 0.05 when both time to PSA progression and time to first use of new antineoplastic therapy were significant. When either failed to show significance.OS was tested at error 0.03.||0.885|0.608|0.0011
73891923|NCT02003924|147316146|SUPERIORITY||Hazard Ratio (HR)|0.959||||0.6534|TWO_SIDED|95.0|0.801|1.149||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||1.149|0.801|0.6534
73891924|NCT02003924|147316147|SUPERIORITY||Hazard Ratio (HR)|0.378|||<|0.0001|TWO_SIDED|95.0|0.282|0.507||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||0.507|0.282|<0.0001
73891925|NCT02003924|147316150|SUPERIORITY||Difference in Response Rate|73.96|||<|0.0001|TWO_SIDED|95.0|70.91|77.02||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease from Baseline \>= 50%||77.02|70.91|<0.0001
73891926|NCT02003924|147316150|SUPERIORITY||Difference in Response Rate|55.52|||<|0.0001|TWO_SIDED|95.0|52.28|58.76||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS|Cochran-Mantel-Haenszel|||Decrease from Baseline \>= 90%||58.76|52.28|<0.0001
73891927|NCT02003924|147316150|SUPERIORITY||Difference in Response Rate|9.65|||<|0.0001|TWO_SIDED|95.0|7.75|11.54||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease to Undetectable Level||11.54|7.75|<0.0001
73891928|NCT04301193|147316225|OTHER||Correlation - R value|0.93|||<|0.05|TWO_SIDED||||||Regression, Linear|||Using standard techniques for estimating sample size, a Delong's test indicated that a total of 61 samples would be sufcient to detect a 0.2 increase in the AUROC from the null hypothesis 0.5, assuming an alpha level of 5% and 90% power \[12\]. The manuscript was referenced against the STROBE checklist for cohort studies. Descriptive statistics were used to present.||||<0.05
73891929|NCT04301193|147316225|OTHER||Correlation - R value|0.77|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
73891930|NCT02656693|147316334|SUPERIORITY|||||||0.00017|||||||Mixed Models Analysis|||||||0.00017
73891931|NCT02656693|147316336|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
73891932|NCT02656693|147316338|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
73891933|NCT02656693|147316339|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
73891934|NCT02656693|147316341|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73891935|NCT02656693|147316342|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
73891936|NCT02656693|147316343|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
73891937|NCT02656693|147316344|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
73891938|NCT02656693|147316345|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||0.35
73891939|NCT02656693|147316346|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
73891940|NCT02656693|147316347|SUPERIORITY|||||||0.33|||||||Mixed Models Analysis|||||||0.33
73891941|NCT02656693|147316348|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
73891942|NCT02656693|147316349|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
73891943|NCT02656693|147316350|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
73891944|NCT02656693|147316351|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
73891945|NCT02656693|147316352|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
73891946|NCT02656693|147316353|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
73891947|NCT02656693|147316354|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.68
73891948|NCT02656693|147316355|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
73891949|NCT02656693|147316356|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
73891950|NCT02656693|147316357|SUPERIORITY|||||||0.42|||||||Mixed Models Analysis|||||||0.42
73891951|NCT02656693|147316358|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||0.23
73891952|NCT02656693|147316359|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
73891953|NCT02082119|147316370|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
73891954|NCT02642315|147316402|OTHER||Median Difference (Net)|36.0||||0.0131|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0131
73891955|NCT02642315|147316403|OTHER||Median Difference (Net)|36.0||||0.0131|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0131
73891956|NCT01193257|147316406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.12085|TWO_SIDED|95.0|0.739|1.036|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\[less than or equal to\] \<=4, greater than \[\>\] 4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.||1.036|0.739|0.12085
73891957|NCT01193257|147316407|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.00038|TWO_SIDED|95.0|0.653|0.885|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\<=4, \>4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.||0.885|0.653|0.00038
73891958|NCT01193257|147316408|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.||||< 0.0001
73891959|NCT01193257|147316409|SUPERIORITY_OR_OTHER|||||||0.12778|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.||||0.12778
73891960|NCT00337675|147316441|SUPERIORITY_OR_OTHER_LEGACY||Rate reduction|5.3|STANDARD_ERROR_OF_MEAN|7.3||0.51||95.0|-11.4|19.6||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.||19.6|-11.4|0.510
73891961|NCT00337675|147316441|SUPERIORITY_OR_OTHER_LEGACY||Rate reduction|-1.2|STANDARD_ERROR_OF_MEAN|7.8||0.884||95.0|-19.2|14.0||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.||14.0|-19.2|0.884
73891962|NCT00337675|147316442|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.176||95.0|-0.46|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.09|-0.46|0.176
73891963|NCT00337675|147316442|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.202||95.0|-0.44|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.09|-0.44|0.202
73891964|NCT00337675|147316443|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.06||0.045||95.0|-0.24|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.00|-0.24|0.045
73891965|NCT00337675|147316443|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.061||95.0|-0.23|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.00|-0.23|0.061
73891966|NCT06170242|147316444|SUPERIORITY|P-values are from analysis of covariance (ANCOVA) with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in least square (LS) means|-540.56|||<|0.0001|TWO_SIDED|95.0|-680.8|-400.33|||ANCOVA|||High Dose versus (vs) Placebo||-400.33|-680.80|<0.0001
73891967|NCT06170242|147316444|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-523.12|||<|0.0001|TWO_SIDED|95.0|-674.46|-371.78|||ANCOVA|||Low Dose vs Placebo||-371.78|-674.46|<0.0001
73891968|NCT06170242|147316444|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS means|-536.3|||<|0.0001|TWO_SIDED|95.0|-641.71|-430.89|||ANCOVA|||Pooled EDP-323 vs Placebo||-430.89|-641.71|<0.0001
73891969|NCT06170242|147316445|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.85|-2.81|||ANCOVA|||High Dose vs Placebo||-2.81|-4.85|<0.0001
73891970|NCT06170242|147316445|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-4.16|||<|0.0001|TWO_SIDED|95.0|-5.44|-2.89|||ANCOVA|||Low Dose vs Placebo||-2.89|-5.44|<0.0001
73891971|NCT06170242|147316446|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-0.29||||0.633|TWO_SIDED|95.0|-1.5|0.92|||ANCOVA|||High Dose vs Placebo||0.92|-1.50|0.6330
73891972|NCT06170242|147316446|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-0.14||||0.8309|TWO_SIDED|95.0|-1.46|1.17|||ANCOVA|||Lose Dose vs Placebo||1.17|-1.46|0.8309
73891973|NCT06170242|147316448|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-1.57||||0.0021|TWO_SIDED|95.0|-2.53|-0.61|||ANCOVA|||High Dose vs Placebo.||-0.61|-2.53|0.0021
73891974|NCT06170242|147316448|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the qRT-PCR viral load value at the time of first dose of IMP.|Difference in LS mean|-1.09||||0.0905|TWO_SIDED|95.0|-2.35|0.18|||ANCOVA|||Lose Dose vs Placebo||0.18|-2.35|0.0905
73891975|NCT06170242|147316451|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-203.63|||<|0.0001|TWO_SIDED|95.0|-272.18|-135.07|||ANCOVA|||High Dose vs Placebo||-135.07|-272.18|<0.0001
73891976|NCT06170242|147316451|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-215.03|||<|0.0001|TWO_SIDED|95.0|-288.84|-141.22|||ANCOVA|||Low Dose vs Placebo||-141.22|-288.84|<0.0001
73891977|NCT06170242|147316452|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-3.22|||<|0.0001|TWO_SIDED|95.0|-4.05|-2.4|||ANCOVA|||High Dose vs Placebo||-2.40|-4.05|<0.0001
73891978|NCT06170242|147316452|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-3.23|||<|0.0001|TWO_SIDED|95.0|-4.11|-2.34|||ANCOVA|||Low Dose vs Placebo||-2.34|-4.11|<0.0001
73891979|NCT06170242|147316453|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|1.44||||0.0238|TWO_SIDED|95.0|0.2|2.68|||ANCOVA|||High Dose vs Placebo||2.68|0.20|0.0238
73891980|NCT06170242|147316453|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|1.68||||0.0134|TWO_SIDED|95.0|0.36|2.99|||ANCOVA|||Low Dose vs Placebo||2.99|0.36|0.0134
73891981|NCT06170242|147316455|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-2.18||||0.0389|TWO_SIDED|95.0|-4.23|-0.12|||ANCOVA|||High Dose vs Placebo||-0.12|-4.23|0.0389
73891982|NCT06170242|147316455|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the cell culture viral load value at the time of first dose of IMP.|Difference in LS mean|-1.31||||0.2713|TWO_SIDED|95.0|-3.73|1.1|||ANCOVA|||Low Dose vs Placebo||1.10|-3.73|0.2713
73891983|NCT06170242|147316457|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-280.61|||<|0.0001|TWO_SIDED|95.0|-404.44|-156.77|||ANCOVA|||High Dose vs Placebo||-156.77|-404.44|<0.0001
73891984|NCT06170242|147316457|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-301.15|||<|0.0001|TWO_SIDED|95.0|-428.53|-173.76|||ANCOVA|||Low Dose vs Placebo||-173.76|-428.53|<0.0001
73891985|NCT06170242|147316458|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-3.64|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.02|||ANCOVA|||High Dose vs Placebo||-2.02|-5.26|<0.0001
73891986|NCT06170242|147316458|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.35|-2.05|||ANCOVA|||Low Dose vs Placebo||-2.05|-5.35|<0.0001
73891987|NCT06170242|147316459|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-1.08||||0.0552|TWO_SIDED|95.0|-2.19|0.03|||ANCOVA|||High Dose vs Placebo||0.03|-2.19|0.0552
73891988|NCT06170242|147316459|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-0.38||||0.5599|TWO_SIDED|95.0|-1.69|0.92|||ANCOVA|||Low Dose vs Placebo||0.92|-1.69|0.5599
73891989|NCT06170242|147316460|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-1.04||||0.0307|TWO_SIDED|95.0|-1.97|-0.1|||ANCOVA|||High Dose vs Placebo||-0.10|-1.97|0.0307
73891990|NCT06170242|147316460|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the TSS value at the time of first dose of IMP.|Difference in LS mean|-0.53||||0.4119|TWO_SIDED|95.0|-1.81|0.76|||ANCOVA|||||0.76|-1.81|0.4119
73891991|NCT06170242|147316461|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-13.37||||0.0042|TWO_SIDED|95.0|-22.34|-4.4|||ANCOVA|||High Dose vs Placebo||-4.40|-22.34|0.0042
73891992|NCT06170242|147316461|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-13.19||||0.0058|TWO_SIDED|95.0|-22.38|-4.0|||ANCOVA|||Low Dose vs Placebo||-4.00|-22.38|0.0058
73891993|NCT06170242|147316462|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-18.72||||0.0026|TWO_SIDED|95.0|-30.61|-6.84|||ANCOVA|||High Dose vs Placebo||-6.84|-30.61|0.0026
73891994|NCT06170242|147316462|SUPERIORITY|P-values are from ANCOVA with treatment group as main effect and the baseline value as a covariate. The baseline value is defined as the biospecimen value at the time of first dose of IMP.|Difference in LS mean|-19.28||||0.0022|TWO_SIDED|95.0|-31.3|-7.26|||ANCOVA|||||-7.26|-31.30|0.0022
73891995|NCT03776812|147316490|OTHER||Hazard Ratio (HR)|0.83||||0.3293|TWO_SIDED|95.0|0.56|1.22|||Cox proportional hazards model|||||1.22|0.56|0.3293
73891996|NCT03776812|147316490|OTHER||Hazard Ratio (HR)|0.66||||0.0384|TWO_SIDED|95.0|0.44|0.98|||Cox proportional hazards model|||||0.98|0.44|0.0384
73891997|NCT00048074|147316505|NON_INFERIORITY_OR_EQUIVALENCE|The IV dosing regimen (2mg q 2 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.257|||<|0.001|TWO_SIDED|95.0|0.701|1.814|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (2mg q 2 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (2mg q 2 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.||1.814|0.701|<0.001
73891998|NCT00048074|147316505|NON_INFERIORITY_OR_EQUIVALENCE|The IV dosing regimen (3mg q 3 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.025|||<|0.001|TWO_SIDED|95.0|0.471|1.578|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (3mg q 3 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (3mg q 3 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.||1.578|0.471|<0.001
73891999|NCT01032889|147316543|SUPERIORITY_OR_OTHER||Difference from placebo|-0.3||||0.052|TWO_SIDED|95.0|-0.61|0.0|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||0.00|-0.61|0.052
73892000|NCT01032889|147316543|SUPERIORITY_OR_OTHER||Difference from placebo|-0.5||||0.003|TWO_SIDED|95.0|-0.77|-0.16|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.16|-0.77|0.003
73892001|NCT01032889|147316544|SUPERIORITY_OR_OTHER||Difference from placebo|-0.2||||0.117|TWO_SIDED|95.0|-0.55|0.06|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||0.06|-0.55|0.117
73892002|NCT01032889|147316544|SUPERIORITY_OR_OTHER||Difference from placebo|-0.6|||<|0.001|TWO_SIDED|95.0|-0.91|-0.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.30|-0.91|<0.001
73892003|NCT01032889|147316545|SUPERIORITY_OR_OTHER||Difference from placebo|-1.4||||0.005|TWO_SIDED|95.0|-2.44|-0.46|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.46|-2.44|0.005
73892004|NCT01032889|147316545|SUPERIORITY_OR_OTHER||Difference from placebo|-2.5|||<|0.001|TWO_SIDED|95.0|-3.48|-1.48|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-1.48|-3.48|<0.001
73892005|NCT01032889|147316546|SUPERIORITY_OR_OTHER||Difference from placebo|-606.0||||0.166|TWO_SIDED|95.0|-1482.0|269.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||269.3|-1482|0.166
73892006|NCT01032889|147316546|SUPERIORITY_OR_OTHER||Difference from placebo|-110.0||||0.803|TWO_SIDED|95.0|-1013.0|792.6|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||792.6|-1013|0.803
73892007|NCT01032889|147316547|SUPERIORITY_OR_OTHER||Difference from placebo|-1.5|||<|0.001|TWO_SIDED|95.0|-2.32|-0.69|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||-0.69|-2.32|<0.001
73892008|NCT01032889|147316547|SUPERIORITY_OR_OTHER||Difference from placebo|-1.7|||<|0.001|TWO_SIDED|95.0|-2.46|-0.85|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||-0.85|-2.46|<0.001
73892009|NCT02039843|147316548|SUPERIORITY|||||||0.052||||||Two-sided a priori alpha level was 0.05.|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in WHO-DAS score adjusted for gender, site, baseline score, time \& timeXgroup interaction||||||0.052
73892010|NCT02039843|147316549|SUPERIORITY|||||||0.421||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PCS score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.421
73892011|NCT02039843|147316550|SUPERIORITY|||||||0.606||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in MCS score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.606
73892012|NCT02039843|147316551|SUPERIORITY|||||||0.21||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PSQI score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.210
73892013|NCT02039843|147316552|SUPERIORITY|||||||0.036||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PCL-5 score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.036
73892014|NCT02039843|147316553|SUPERIORITY|||||||0.079||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PHQ-9 score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.079
73892015|NCT02039843|147316554|SUPERIORITY|||||||0.155||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in DAR score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.155
73892016|NCT02039843|147316555|SUPERIORITY|||||||0.157||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Generalized linear mixed repeated measures analysis on group difference in SBI adjusted for gender, site, baseline SBI, time, and timeXgroup||||||0.157
73892017|NCT02039843|147316556|SUPERIORITY|||||||0.43||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.430
73892018|NCT02039843|147316557|SUPERIORITY|||||||0.358||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.358
73892019|NCT02039843|147316558|SUPERIORITY|||||||0.39||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.39
73892020|NCT02039843|147316568|SUPERIORITY|||||||0.383||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.383
73892021|NCT02039843|147316569|SUPERIORITY|||||||0.932|||||||Regression, Linear|||||||0.932
73892022|NCT00740857|147316613|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
73892023|NCT00740857|147316613|SUPERIORITY_OR_OTHER|||||||0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||0.001
73892024|NCT00740857|147316613|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
73892025|NCT00740857|147316614|SUPERIORITY_OR_OTHER|||||||0.118|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.118
73892026|NCT00740857|147316614|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60....||||<0.001
73892027|NCT00740857|147316615|SUPERIORITY_OR_OTHER|||||||0.041|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.041
73892028|NCT00740857|147316615|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.||||<0.001
73892029|NCT00740857|147316616|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
73892030|NCT00740857|147316617|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.056
73892031|NCT00740857|147316617|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.||||<0.001
73892032|NCT00740857|147316618|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
73892033|NCT00740857|147316619|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
73892034|NCT00740857|147316620|SUPERIORITY_OR_OTHER||||||<|0.001|||||||proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
73892035|NCT03532451|147316627|SUPERIORITY|||||||0.08|||||||Wilcoxon Signed-Rank Test|||Null hypothesis is the change in CD8+ cell density is not significantly different from zero.||||0.08
73892036|NCT03532451|147316627|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank Test|||||||0.002
73892037|NCT03532451|147316628|SUPERIORITY|||||||0.88|||||||Wilcoxon rank sum test|||||||0.88
73892038|NCT00912197|147316629|SUPERIORITY|||||||0.135|||||||ANCOVA|||||||0.135
73892039|NCT00912197|147316630|SUPERIORITY|||||||0.688|||||||ANCOVA|||||||0.688
73892040|NCT00912197|147316631|SUPERIORITY|||||||0.715|||||||t-test, 2 sided|||after treatment, 56 days||||0.715
73892041|NCT00912197|147316632|SUPERIORITY|||||||0.578|||||||ANCOVA|||||||0.578
73892042|NCT00912197|147316632|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||baseline to after treatment, at 56 days||||0.007
73892043|NCT00912197|147316632|SUPERIORITY|||||||0.05||||||calculated|t-test, 2 sided|||baseline to after treatment, at 56 days||||0.05
73892044|NCT00912197|147316636|SUPERIORITY|||||||0.024|||||||ANCOVA|||Acetate||||0.024
73892045|NCT00756613|147316642|EQUIVALENCE|We considered a 20% reduction in primary events to be a reasonable goal of intensive glycemic control over the anticipated 15-year study time period. This effect size was chosen by taking into consideration both the probability of observing an effect of that size given the level of achieved A1c separation, and the perceived value to the patient of this level of benefit relative to the risk and burden of intensive glycemic control.|Cox Proportional Hazard|0.91||||0.24|TWO_SIDED|95.0|0.78|1.06|||Regression, Cox|||To determine the long term effects of intensive glycemic control in type 2 diabetes on major cardiovascular events.||1.06|0.78|0.24
73892046|NCT00756613|147316643|EQUIVALENCE|The equivalence margin is expected 20% reduction for the intensive treatment group compared to the standard treatment group.|Cox Proportional Hazard|1.02||||0.81|TWO_SIDED|95.0|0.88|1.18|||Regression, Cox|||||1.18|0.88|0.81
73892047|NCT00756613|147316644|EQUIVALENCE|The equivalence margin is 20% reduction of intensive treatment group versus standard treatment group.|Cox Proportional Hazard|0.9||||0.48|TWO_SIDED|95.0|0.67|1.2|||Regression, Cox|||||1.20|0.67|0.48
73892048|NCT00756613|147316646|EQUIVALENCE|T-test comparing between the two groups of treatment using the average score of last two surveys.|Mean Difference (Final Values)|1.61||||0.172|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.172
73892049|NCT03801044|147316647|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
73892050|NCT01326104|147316663|SUPERIORITY||comparing two curves|0.286||||0.927|TWO_SIDED|90.0|0.107|0.764||This is the p-value comparing Group A with historical control.|Log Rank|One sample log rank.||Based on published literature, PFS-12 for patients with recurrent disease after initiating treatment with HDC + PBSCT or standard salvage therapy was 33% (95% confidence interval of 10%, 59%). The study was designed to differentiate between a PFS-12 rate of 33% (null hypothesis) and 55% (alternative hypothesis). If 35 patients enrolled, this assessment has 90% power assuming a type I error rate of 0.10. We assume that PFS of historical controls follows exponential distribution.||0.764|0.107|0.927
73892051|NCT01326104|147316663|SUPERIORITY||compare two curves|0.0|||<|0.001|TWO_SIDED|||||This is the p-value comparing Group B with historical control.|Log Rank|||Based on published literature, PFS-12 for patients with recurrent disease after initiating treatment with HDC + PBSCT or standard salvage therapy was 33% (95% confidence interval of 10%, 59%). The study was designed to differentiate between a PFS-12 rate of 33% (null hypothesis) and 55% (alternative hypothesis). If 35 patients enrolled, this assessment has 90% power assuming a type I error rate of 0.10. We assume that PFS of historical controls follows exponential distribution.||||<0.001
73892052|NCT01326104|147316663|SUPERIORITY||Comparing two curves|0.091|||<|0.001|TWO_SIDED|90.0|0.03|0.276||This is the p-value comparing Groups A and B combined with historical control.|Log Rank|||||0.276|0.03|<0.001
73892053|NCT01287741|147316669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4753|TWO_SIDED|95.0|0.78|1.12|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).||||1.12|0.78|0.4753
73892054|NCT01287741|147316670|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2736|TWO_SIDED|95.0|0.72|1.1|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).||||1.10|0.72|0.2736
73892055|NCT04421027|147316685|SUPERIORITY||Odds Ratio (OR)|0.85||||0.18|TWO_SIDED|95.0|0.67|1.08|||Regression, Logistic|||||1.08|0.67|0.1800
73892056|NCT04421027|147316686|SUPERIORITY||Odds Ratio (OR)|1.12||||0.728|TWO_SIDED|95.0|0.58|2.16|||Regression, Logistic|||||2.16|0.58|0.7280
73892057|NCT04421027|147316687|SUPERIORITY||Odds Ratio (OR)|1.07||||0.5444|TWO_SIDED|95.0|0.86|1.34|||Regression, Logistic|||||1.34|0.86|0.5444
73892058|NCT04421027|147316688|SUPERIORITY||LS Mean difference (net)|0.75|STANDARD_ERROR_OF_MEAN|0.399||0.0586|TWO_SIDED|95.0|0.0|1.5|||ANOVA|||||1.5|-0.0|0.0586
73892059|NCT04421027|147316689|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.1453|TWO_SIDED|95.0|0.99|1.24|||Log Rank|||||1.24|0.99|0.1453
73892060|NCT04421027|147316690|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0464|TWO_SIDED|95.0|1.0|1.47|||Proportional Odds Model|||Day 4||1.47|1.00|0.0464
73892061|NCT04421027|147316691|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0172|TWO_SIDED|95.0|1.04|1.49|||Proportional Odds Model|||||1.49|1.04|0.0172
73892062|NCT04421027|147316692|SUPERIORITY||Odds Ratio (OR)|1.17||||0.0921|TWO_SIDED|95.0|0.97|1.41|||Proportional Odds Model|||||1.41|0.97|0.0921
73892063|NCT04421027|147316693|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0168|TWO_SIDED|95.0|1.05|1.56|||Proportional Odds Model|||||1.56|1.05|0.0168
73892064|NCT04421027|147316694|SUPERIORITY||LS Mean Difference (Net)|-0.76|STANDARD_ERROR_OF_MEAN|0.408||0.0626|TWO_SIDED|95.0|-1.6|0.0|||ANOVA|||||0.0|-1.6|0.0626
73892065|NCT04421027|147316695|SUPERIORITY||Odds Ratio (OR)|1.15||||0.429|TWO_SIDED|95.0|0.81|1.63|||Regression, Logistic|||||1.63|0.81|0.4290
73892066|NCT04421027|147316696|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0018|TWO_SIDED|95.0|0.41|0.78|||Log Rank|||||0.78|0.41|0.0018
73892067|NCT04421027|147316697|SUPERIORITY||LS Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.323||0.9526|TWO_SIDED|95.0|-0.62|0.65|||ANOVA|||||0.65|-0.62|0.9526
73892068|NCT04421027|147316698|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.1831|TWO_SIDED|95.0|0.741|1.061|||Log Rank|||||1.061|0.741|0.1831
73892069|NCT04421027|147316699|SUPERIORITY||Hazard Ratio (HR)|1.202||||0.0243|TWO_SIDED|95.0|1.017|1.421|||Log Rank|||||1.421|1.017|0.0243
73892070|NCT04421027|147316700|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.128||0.191|TWO_SIDED|95.0|-0.42|0.08|||Mixed Models Analysis|||Day 4||0.08|-0.42|0.191
73892071|NCT04421027|147316700|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.161||0.278|TWO_SIDED|95.0|-0.49|0.14|||Mixed Models Analysis|||Day 7||0.14|-0.49|0.278
73892072|NCT04421027|147316700|SUPERIORITY||LS Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.187||0.496|TWO_SIDED|95.0|-0.49|0.24|||Mixed Models Analysis|||Day 10||0.24|-0.49|0.496
73892073|NCT04421027|147316700|SUPERIORITY||LS Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.226||0.263|TWO_SIDED|95.0|-0.7|0.19|||Mixed Models Analysis|||Day 14||0.19|-0.70|0.263
73892074|NCT04421027|147316702|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6436|TWO_SIDED||||||Log Rank|||||||0.6436
73892075|NCT04421027|147316703|SUPERIORITY||Hazard Ratio (HR)|1.124||||0.127|TWO_SIDED||||||Log Rank|||||||0.1270
73892076|NCT04421027|147316704|SUPERIORITY||LS Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3058|TWO_SIDED|95.0|-0.68|0.21|||ANOVA|||||0.21|-0.68|0.3058
73892077|NCT04421027|147316705|SUPERIORITY||LS Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.306||0.7073|TWO_SIDED|95.0|-0.49|0.72|||ANOVA|||||0.72|-0.49|0.7073
73892078|NCT05407064|147316733|SUPERIORITY|Mean change from baseline and mean difference between MM120 dose groups and placebo were estimated using model averaging method (of 3 models). The minimally efficacious dose was defined as a placebo-adjusted improvement of 2.5 points on the HAM-A, with a statistical significance set at an alpha level of 0.05.||||||||||||||||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 4 in total HAM-A score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed, and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.|A test statistic was derived from the data using an ANCOVA model with change from Baseline to Week 4 for the HAM-A Total Score as a response variable, treatment arm and Baseline value of HAM-A Total Score as covariates. The ANCOVA model was repeated for each imputed dataset, which resulted in a set of LS mean estimates for all dose groups and the related covariance matrices. Rubin's rule was used to combine the multiple sets of LS mean estimates and the related covariance matrices to a single set of LS mean estimates of change from Baseline to Week 4 for HAM-A Total Score for all dose groups and the related covariance matrix. The SAS procedure PROC MIANALYZE was used to combine the results from imputed datasets.|||
73892079|NCT05407064|147316734|SUPERIORITY|Mean change from baseline and mean difference between MM120 dose groups and placebo were estimated using model averaging method (of 3 models). The minimally efficacious dose was defined as a placebo-adjusted improvement of 2.5 points on the HAM-A, with a statistical significance set at an alpha level of 0.05.||||||||||||||||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 8 in total HAM-A score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed, and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.|A test statistic was derived from the data using an ANCOVA model with change from Baseline to Week 8 for the HAM-A Total Score as a response variable, treatment arm and Baseline value of HAM-A Total Score as covariates. The ANCOVA model was repeated for each imputed dataset, which resulted in a set of LS mean estimates for all dose groups and the related covariance matrices. Rubin's rule was used to combine the multiple sets of LS mean estimates and the related covariance matrices to a single set of LS mean estimates of change from Baseline to Week 8 for HAM-A Total Score for all dose groups and the related covariance matrix. The SAS procedure PROC MIANALYZE was used to combine the results from imputed datasets.|||
73892080|NCT05407064|147316735|SUPERIORITY|||||||0.1157|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.1157
73892081|NCT05407064|147316735|SUPERIORITY|||||||0.663|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.6630
73892082|NCT05407064|147316735|SUPERIORITY|||||||0.0004|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0004
73892083|NCT05407064|147316735|SUPERIORITY|||||||0.01|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0100
73892084|NCT05407064|147316736|SUPERIORITY|||||||0.2309|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.2309
73892085|NCT05407064|147316736|SUPERIORITY|||||||0.7218|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.7218
73892086|NCT05407064|147316736|SUPERIORITY|||||||0.0637|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0637
73892087|NCT05407064|147316736|SUPERIORITY|||||||0.0216|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0216
73892088|NCT05407064|147316737|SUPERIORITY|||||||0.1006|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.1006
73892089|NCT05407064|147316737|SUPERIORITY|||||||0.2225|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.2225
73892090|NCT05407064|147316737|SUPERIORITY|||||||0.0025|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0025
73892091|NCT05407064|147316737|SUPERIORITY|||||||0.0042|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0042
73892092|NCT05407064|147316738|SUPERIORITY|||||||0.6258|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.6258
73892093|NCT05407064|147316738|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.95
73892094|NCT05407064|147316738|SUPERIORITY|||||||0.0174|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0174
73892095|NCT05407064|147316738|SUPERIORITY|||||||0.0206|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0206
73892096|NCT05407064|147316739|SUPERIORITY|||||||0.5538|||||||t-test, 2 sided|||Assessment of change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.5538
73892097|NCT05407064|147316739|SUPERIORITY|||||||0.665|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.6650
73892098|NCT05407064|147316739|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0190
73892099|NCT05407064|147316739|SUPERIORITY|||||||0.0034|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0034
73892100|NCT05407064|147316740|SUPERIORITY|||||||0.7236|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.7236
73892101|NCT05407064|147316740|SUPERIORITY|||||||0.9738|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.9738
73892102|NCT05407064|147316740|SUPERIORITY|||||||0.0338|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0338
73892103|NCT05407064|147316740|SUPERIORITY|||||||0.0282|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0282
73892104|NCT05407064|147316741|SUPERIORITY|||||||0.9302|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.9302
73892105|NCT05407064|147316741|SUPERIORITY|||||||0.6763|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.6763
73892106|NCT05407064|147316741|SUPERIORITY|||||||0.0816|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0816
73892107|NCT05407064|147316741|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0190
73892108|NCT05407064|147316742|SUPERIORITY|||||||0.5647|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.5647
73892109|NCT05407064|147316742|SUPERIORITY|||||||0.3497|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3497
73892110|NCT05407064|147316742|SUPERIORITY|||||||0.0229|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0229
73892111|NCT05407064|147316742|SUPERIORITY|||||||0.0073|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0073
73892112|NCT05407064|147316743|SUPERIORITY|||||||0.0158|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0158
73892113|NCT05407064|147316743|SUPERIORITY|||||||0.0429|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0429
73892114|NCT05407064|147316743|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0001
73892115|NCT05407064|147316743|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
73892116|NCT05407064|147316744|SUPERIORITY|||||||0.0804|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0804
73892117|NCT05407064|147316744|SUPERIORITY|||||||0.0532|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0532
73892118|NCT05407064|147316744|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0001
73892119|NCT05407064|147316744|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
73892120|NCT05407064|147316745|SUPERIORITY|||||||0.2152|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.2152
73892121|NCT05407064|147316745|SUPERIORITY|||||||0.3369|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3369
73892122|NCT05407064|147316745|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0010
73892123|NCT05407064|147316745|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0046
73892124|NCT05407064|147316746|SUPERIORITY|||||||0.4489|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.4489
73892125|NCT05407064|147316746|SUPERIORITY|||||||0.7326|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.7326
73892126|NCT05407064|147316746|SUPERIORITY|||||||0.0492|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0492
73892127|NCT05407064|147316746|SUPERIORITY|||||||0.0131|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0131
73892128|NCT05407064|147316747|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3330
73892129|NCT05407064|147316747|SUPERIORITY|||||||0.1193|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.1193
73892130|NCT05407064|147316747|SUPERIORITY|||||||0.0032|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0032
73892131|NCT05407064|147316747|SUPERIORITY|||||||0.0127|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0127
73892132|NCT05407064|147316748|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0046
73892133|NCT05407064|147316748|SUPERIORITY|||||||0.0052|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0052
73892134|NCT05407064|147316748|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
73892135|NCT05407064|147316748|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
73892136|NCT05407064|147316749|SUPERIORITY|||||||0.0567|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0567
73892137|NCT05407064|147316749|SUPERIORITY|||||||0.0235|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0235
73892138|NCT05407064|147316749|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
73892139|NCT05407064|147316749|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
73892140|NCT05407064|147316750|SUPERIORITY|||||||0.2632|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.2632
73892141|NCT05407064|147316750|SUPERIORITY|||||||0.2962|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.2962
73892142|NCT05407064|147316750|SUPERIORITY|||||||0.0013|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0013
73892143|NCT05407064|147316750|SUPERIORITY|||||||0.0547|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0547
73892144|NCT05407064|147316751|SUPERIORITY|||||||0.0937|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0937
73892145|NCT05407064|147316751|SUPERIORITY|||||||0.823|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.8230
73892146|NCT05407064|147316751|SUPERIORITY|||||||0.0032|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0032
73892147|NCT05407064|147316751|SUPERIORITY|||||||0.0129|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0129
73892148|NCT05407064|147316752|SUPERIORITY|||||||0.1889|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1889
73892149|NCT05407064|147316752|SUPERIORITY|||||||0.1589|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1589
73892150|NCT05407064|147316752|SUPERIORITY|||||||0.0008|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0008
73892151|NCT05407064|147316752|SUPERIORITY|||||||0.0194|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0194
73892152|NCT05407064|147316753|SUPERIORITY|||||||0.0057|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0057
73892153|NCT05407064|147316753|SUPERIORITY|||||||0.0168|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0168
73892154|NCT05407064|147316753|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||0.0000
73892155|NCT05407064|147316753|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
73892156|NCT05407064|147316754|SUPERIORITY|||||||0.0958|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0958
73892157|NCT05407064|147316754|SUPERIORITY|||||||0.0544|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0544
73892158|NCT05407064|147316754|SUPERIORITY|||||||0.0029|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0029
73797096|NCT02555254|147139893|SUPERIORITY|||||||0.55|||||||Wilcoxon's rank test|||||||0.55
73797097|NCT04140032|147139897|SUPERIORITY||Difference between groups in change in B|-0.18|STANDARD_DEVIATION|0.06||0.003|TWO_SIDED|95.0|-0.31|-0.06|||Mixed Models Analysis|p \< 0.05 considered significant||||-0.06|-0.31|0.003
73892159|NCT05407064|147316754|SUPERIORITY|||||||0.0006|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0006
73892160|NCT05407064|147316755|SUPERIORITY|||||||0.2038|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.2038
73797098|NCT04140032|147139898|SUPERIORITY||Odds ratio for difference between groups|1.29||||0.7|TWO_SIDED|95.0|0.034|4.91|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||4.91|.034|0.7
73797099|NCT04140032|147139899|SUPERIORITY||Difference between groups in change in f|-0.2|STANDARD_DEVIATION|0.19||0.3|TWO_SIDED|95.0|-0.58|0.17|||Mixed Models Analysis|||||0.17|-0.58|0.3
73892161|NCT05407064|147316755|SUPERIORITY|||||||0.1977|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.1977
73892162|NCT05407064|147316755|SUPERIORITY|||||||0.0357|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.0357
73892163|NCT05407064|147316755|SUPERIORITY|||||||0.0302|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.0302
73892164|NCT05407064|147316756|SUPERIORITY|||||||0.2165|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2165
73892165|NCT05407064|147316756|SUPERIORITY|||||||0.6868|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.6868
73892166|NCT05407064|147316756|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.1350
73892167|NCT05407064|147316756|SUPERIORITY|||||||0.0273|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0273
73892168|NCT05407064|147316757|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2450
73892169|NCT05407064|147316757|SUPERIORITY|||||||0.3461|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.3461
73892170|NCT05407064|147316757|SUPERIORITY|||||||0.111|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.1110
73892171|NCT05407064|147316757|SUPERIORITY|||||||0.2386|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2386
73892172|NCT05407064|147316758|SUPERIORITY|||||||0.1475|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1475
73892173|NCT05407064|147316758|SUPERIORITY|||||||0.0308|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0308
73892174|NCT05407064|147316758|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
73797100|NCT04140032|147139903|SUPERIORITY||Odds ratio for difference between groups|1.1|STANDARD_ERROR_OF_MEAN|0.35||0.8|TWO_SIDED|95.0|0.56|2.16|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||2.16|0.56|0.8
73797101|NCT04140032|147139903|SUPERIORITY||Odds ratio for difference between groups|1.1||||0.8|TWO_SIDED|95.0|0.56|2.16|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||2.16|0.56|0.8
73797102|NCT06075277|147139904|OTHER||Ratios of adjusted geometric means [%]|126.64|||||TWO_SIDED|90.0|112.09|143.08|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 19.8|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||143.08|112.09|
73797103|NCT06075277|147139905|OTHER||Ratios of adjusted geometric means [%]|126.12|||||TWO_SIDED|90.0|106.34|149.58|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 27.9.|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||149.58|106.34|
73797104|NCT06075277|147139906|OTHER||Ratios of adjusted geometric means [%]|126.04|||||TWO_SIDED|90.0|111.7|142.21|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 19.6.|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||142.21|111.70|
73892175|NCT05407064|147316758|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0004
73892176|NCT05407064|147316759|SUPERIORITY|||||||0.0873|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0873
73892177|NCT05407064|147316759|SUPERIORITY|||||||0.1702|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1702
73892178|NCT05407064|147316759|SUPERIORITY|||||||0.0007|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0007
73797127|NCT01644617|147140018|SUPERIORITY_OR_OTHER||Difference in Least Squares Means (LSM)|-3.62|||<|0.001|TWO_SIDED|95.0|-4.85|-2.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-2.39|-4.85|<0.001
73797128|NCT01644617|147140018|SUPERIORITY_OR_OTHER||Difference in LSM|-1.98||||0.003|TWO_SIDED|95.0|-3.24|-0.72|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.72|-3.24|0.003
73797129|NCT01644617|147140019|SUPERIORITY_OR_OTHER||Difference in LSM|-2.08|||<|0.001|TWO_SIDED|95.0|-3.14|-1.03|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-1.03|-3.14|<0.001
73892179|NCT05407064|147316759|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0001
73892180|NCT05407064|147316760|SUPERIORITY|||||||0.4193|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.4193
73892181|NCT05407064|147316760|SUPERIORITY|||||||0.1663|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1663
73892182|NCT05407064|147316760|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0002
73797130|NCT01644617|147140019|SUPERIORITY_OR_OTHER||Difference in LSM|-1.23||||0.032||95.0|-2.36|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.11|-2.36|0.032
73797131|NCT01644617|147140020|SUPERIORITY_OR_OTHER||Difference in LSM|-1.37||||0.007|TWO_SIDED|95.0|-2.34|-0.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.39|-2.34|0.007
73797132|NCT01644617|147140020|SUPERIORITY_OR_OTHER||Difference in LSM|-0.54||||0.198|TWO_SIDED|95.0|-1.38|0.29|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.29|-1.38|0.198
73797133|NCT01644617|147140021|SUPERIORITY_OR_OTHER||Difference in LSM|-4.84|||<|0.001|TWO_SIDED|95.0|-6.59|-3.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-3.09|-6.59|<0.001
73797134|NCT01644617|147140021|SUPERIORITY_OR_OTHER||Difference in LSM|-2.65||||0.003|TWO_SIDED|95.0|-4.35|-0.95|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.95|-4.35|0.003
73797135|NCT01644617|147140022|SUPERIORITY_OR_OTHER||Difference in LSM|-2.62|||<|0.001|TWO_SIDED|95.0|-4.12|-1.13|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-1.13|-4.12|<0.001
73797136|NCT01644617|147140022|SUPERIORITY_OR_OTHER||Difference in LSM|-1.37||||0.091|TWO_SIDED|95.0|-2.96|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.22|-2.96|0.091
73797137|NCT01644617|147140023|SUPERIORITY_OR_OTHER||Difference in LSM|-1.97||||0.004|TWO_SIDED|95.0|-3.3|-0.64|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.64|-3.30|0.004
73797138|NCT01644617|147140023|SUPERIORITY_OR_OTHER||Difference in LSM|-0.83||||0.181|TWO_SIDED|95.0|-2.06|0.4|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.40|-2.06|0.181
73797139|NCT01644617|147140024|SUPERIORITY_OR_OTHER||Difference in LSM|-1.27|||<|0.001|TWO_SIDED|95.0|-1.92|-0.62|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.62|-1.92|<0.001
73797140|NCT01644617|147140024|SUPERIORITY_OR_OTHER||Difference in LSM|-0.77||||0.023|TWO_SIDED|95.0|-1.43|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.11|-1.43|0.023
73797141|NCT01644617|147140025|SUPERIORITY_OR_OTHER||Difference in LSM|-0.53||||0.082|TWO_SIDED|95.0|-1.13|0.07|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.07|-1.13|0.082
73797142|NCT01644617|147140025|SUPERIORITY_OR_OTHER||Difference in LSM|-0.13||||0.691|TWO_SIDED|95.0|-0.79|0.52|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.52|-0.79|0.691
73797143|NCT01644617|147140026|SUPERIORITY_OR_OTHER||Difference in LSM|-0.61||||0.023|TWO_SIDED|95.0|-1.14|-0.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.09|-1.14|0.023
73797144|NCT01644617|147140026|SUPERIORITY_OR_OTHER||Difference in LSM|-0.34||||0.235|TWO_SIDED|95.0|-0.9|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.22|-0.90|0.235
73797145|NCT01644617|147140029|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.55|||<|0.001|TWO_SIDED|95.0|0.43|0.68|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.68|0.43|<0.001
73797146|NCT01644617|147140029|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.42|||<|0.001|TWO_SIDED|95.0|0.33|0.52|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.52|0.33|<0.001
73797147|NCT01644617|147140029|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.52|||<|0.001|TWO_SIDED|95.0|0.41|0.64|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.64|0.41|<0.001
73797148|NCT01644617|147140029|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.39|||<|0.001|TWO_SIDED|95.0|0.3|0.48|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.48|0.30|<0.001
73892183|NCT05407064|147316760|SUPERIORITY|||||||0.0306|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0306
73797149|NCT01644617|147140030|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.33|0.13|<0.001
73797150|NCT01644617|147140030|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.25|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.25|0.12|<0.001
73797151|NCT01644617|147140030|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.32|||<|0.001|TWO_SIDED|95.0|0.23|0.42|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.42|0.23|<0.001
73892184|NCT05407064|147316761|SUPERIORITY|||||||0.0534|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.0534
73892185|NCT05407064|147316761|SUPERIORITY|||||||0.6551|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.6551
73797152|NCT01644617|147140030|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.25|||<|0.001|TWO_SIDED|95.0|0.16|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.33|0.16|<0.001
73797153|NCT01644617|147140031|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|12.4||||||95.0|-3.6|28.9|||||Analysis based on the Miettinen and Nurminen method|||28.9|-3.6|
73797154|NCT01644617|147140031|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|9.8|||||TWO_SIDED|95.0|-7.0|26.6|||||Analysis based on the Miettinen and Nurminen method|||26.6|-7.0|
73797155|NCT01644617|147140032|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|-7.5|||||TWO_SIDED|95.0|-22.6|6.7|||||Analysis based on the Miettinen and Nurminen method|||6.7|-22.6|
73797156|NCT01644617|147140032|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|-14.6|||||TWO_SIDED|95.0|-28.5|-5.4|||||Analysis based on the Miettinen and Nurminen method|||-5.4|-28.5|
73797179|NCT01906515|147140180|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
73797180|NCT01906515|147140181|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73892186|NCT05407064|147316761|SUPERIORITY|||||||0.0079|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.0079
73892187|NCT05407064|147316761|SUPERIORITY|||||||0.1133|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.1133
73892188|NCT05407064|147316762|SUPERIORITY|||||||0.1248|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1248
73892189|NCT05407064|147316762|SUPERIORITY|||||||0.1788|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1788
73797192|NCT03975491|147140383|SUPERIORITY||Mean Difference (Net)|20.9||||0.32|TWO_SIDED|95.0|-17.1|76.2|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||76.2|-17.1|0.32
73797193|NCT03975491|147140384|SUPERIORITY||Mean Difference (Net)|11.4||||0.25|TWO_SIDED|95.0|-7.5|34.0|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||34.0|-7.5|0.25
73797194|NCT03975491|147140385|SUPERIORITY||Mean Difference (Net)|-3.6||||0.52|TWO_SIDED|95.0|-13.7|7.7|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||7.7|-13.7|0.52
73797195|NCT03975491|147140386|SUPERIORITY||Mean Difference (Net)|0.59||||0.21|TWO_SIDED|95.0|-0.33|1.51|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||1.51|-0.33|0.21
73797196|NCT03975491|147140388|SUPERIORITY||Mean Difference (Net)|0.0005||||0.73|TWO_SIDED|95.0|-0.0024|0.0034|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||0.0034|-0.0024|0.73
73797197|NCT02260570|147140405|SUPERIORITY||F value|24.1|||<|0.0001|TWO_SIDED|||||This p-value is adjusted for multiple comparisons.|ANOVA|F(1,1,60) = 24.1, p \< 0.0001, adjusted r\^2 = 0.275||||||<0.0001
73797198|NCT02260570|147140406|SUPERIORITY||F value|6.23||||0.0184|TWO_SIDED|||||This p-value is adjusted for multiple comparisons.|ANOVA|F(1,30) = 6.23, p = 0.0184, adjusted r\^2 = 0.144||||||0.0184
73797199|NCT05026177|147140407|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.5335|TWO_SIDED|95.0|-0.96|1.86|||Mixed Models Analysis|||||1.86|-0.96|0.5335
73797200|NCT05026177|147140407|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.5836|TWO_SIDED|95.0|-0.99|1.76|||Mixed Models Analysis|||||1.76|-0.99|0.5836
73797201|NCT05026177|147140408|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.0763|TWO_SIDED|95.0|-3.3|0.17|||Mixed Models Analysis|||||0.17|-3.30|0.0763
73797202|NCT05026177|147140408|SUPERIORITY||Mean Difference (Final Values)|-1.24||||0.153|TWO_SIDED|95.0|-2.93|0.46|||Mixed Models Analysis|||||0.46|-2.93|0.1530
73892190|NCT05407064|147316762|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0030
73797203|NCT04856917|147140420|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.21||0.3757|TWO_SIDED|90.0|-2.47|8.19|||LRMM|||Least square (LS) Mean, SE, 90% CI, \& p-value was based on a linear repeated measures model (LRMM) which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.||8.19|-2.47|0.3757
73892191|NCT05407064|147316762|SUPERIORITY|||||||0.0534|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0534
73797204|NCT04856917|147140420|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|3.22||0.6183|TWO_SIDED|90.0|-3.73|6.95|||LRMM|||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.||6.95|-3.73|0.6183
73797205|NCT04856917|147140421|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.7||0.249|TWO_SIDED|90.0|-0.85|4.8||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||4.80|-0.85|0.2490
73797206|NCT04856917|147140421|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.72||0.0708|TWO_SIDED|90.0|0.28|5.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||5.99|0.28|0.0708
73797207|NCT04856917|147140421|SUPERIORITY||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|2.68||0.004|TWO_SIDED|90.0|3.44|12.34||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||12.34|3.44|0.0040
73797208|NCT04856917|147140421|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.71||0.206|TWO_SIDED|90.0|-1.05|7.94||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||7.94|-1.05|0.2060
73797209|NCT04856917|147140421|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.66||0.4341|TWO_SIDED|90.0|-2.33|6.51||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||6.51|-2.33|0.4341
73797210|NCT04856917|147140421|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.73||0.7307|TWO_SIDED|90.0|-3.59|5.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||5.48|-3.59|0.7307
73797211|NCT04856917|147140421|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.93||0.3261|TWO_SIDED|90.0|-1.97|7.77||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||7.77|-1.97|0.3261
73797212|NCT04856917|147140421|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.95||0.8221|TWO_SIDED|90.0|-5.56|4.23||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||4.23|-5.56|0.8221
73797213|NCT04856917|147140422|SUPERIORITY||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|6.2||0.3008|TWO_SIDED|90.0|-3.84|16.73||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||16.73|-3.84|0.3008
73797214|NCT04856917|147140422|SUPERIORITY||LS Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|6.27||0.0878|TWO_SIDED|90.0|0.4|21.19||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||21.19|0.40|0.0878
73797215|NCT04856917|147140422|SUPERIORITY||LS Mean Difference|26.6|STANDARD_ERROR_OF_MEAN|8.42||0.002|TWO_SIDED|90.0|12.64|40.57||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||40.57|12.64|0.0020
73797216|NCT04856917|147140422|SUPERIORITY||LS Mean Difference|14.0|STANDARD_ERROR_OF_MEAN|8.5||0.1029|TWO_SIDED|90.0|-0.12|28.09||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||28.09|-0.12|0.1029
73797217|NCT04856917|147140422|SUPERIORITY||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|8.82||0.5427|TWO_SIDED|90.0|-9.25|20.02||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||20.02|-9.25|0.5427
73797218|NCT04856917|147140422|SUPERIORITY||LS Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|9.06||0.5833|TWO_SIDED|90.0|-10.05|20.02||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||20.02|-10.05|0.5833
73797219|NCT04856917|147140422|SUPERIORITY||LS Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|10.98||0.3293|TWO_SIDED|90.0|-7.46|28.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||28.99|-7.46|0.3293
73797220|NCT04856917|147140422|SUPERIORITY||LS Mean Difference|14.5|STANDARD_ERROR_OF_MEAN|10.99||0.19|TWO_SIDED|90.0|-3.74|32.74||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||32.74|-3.74|0.1900
73797221|NCT04856917|147140422|SUPERIORITY||LS Mean Difference|11.7|STANDARD_ERROR_OF_MEAN|9.38||0.2168|TWO_SIDED|90.0|-3.91|27.23||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||27.23|-3.91|0.2168
73797222|NCT04856917|147140422|SUPERIORITY||LS Mean Difference|7.8|STANDARD_ERROR_OF_MEAN|9.42||0.4089|TWO_SIDED|90.0|-7.82|23.45||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||23.45|-7.82|0.4089
73797223|NCT04856917|147140423|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.53||0.4229|TWO_SIDED|90.0|-2.16|6.24||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||6.24|-2.16|0.4229
73797224|NCT04856917|147140423|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.56||0.6027|TWO_SIDED|90.0|-2.91|5.59||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||5.59|-2.91|0.6027
73797225|NCT04856917|147140423|SUPERIORITY||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|2.5||0.2655|TWO_SIDED|90.0|-1.35|6.95||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||6.95|-1.35|0.2655
73797226|NCT04856917|147140423|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|2.53||0.6229|TWO_SIDED|90.0|-2.95|5.44||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||5.44|-2.95|0.6229
73892192|NCT02930018|147316804|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS (Acute Ischemic Stroke) patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.146||||0.335|TWO_SIDED|95.0|0.869|1.511||2 sided 0.05 significance level.|Regression, Logistic|||The primary hypothesis was that administration of nerinetide (NA-1) would result in an increase in the proportion of responders. The primary analysis was a Wald test for treatment group difference in the primary outcome from a logistic regression adjusted for the 2 stratification variables (alteplase use, first declared thrombectomy device), and the 6 covariates used in the minimization. The trial was designed to have 80% power to detect an 8.7% absolute difference between groups.||1.511|0.869|0.335
73892193|NCT02930018|147316805|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.024||||0.866|TWO_SIDED|95.0|0.781|1.342||2 sided 0.05 significance level.|Regression, Logistic|||||1.342|0.781|0.866
73892194|NCT02930018|147316806|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.776||||0.199|TWO_SIDED|95.0|0.527|1.143||2 sided 0.05 significance level.|Regression, Logistic|||||1.143|0.527|0.199
73892195|NCT02930018|147316807|SUPERIORITY||Odds Ratio (OR)|1.657||||0.028|TWO_SIDED|95.0|1.055|2.603|||Regression, Logistic|||||2.603|1.055|0.028
73892196|NCT02930018|147316807|SUPERIORITY||Absolute Risk Difference (%)|9.6|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
73892197|NCT02930018|147316807|SUPERIORITY||Relative Risk Difference (%)|19.3|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
73892198|NCT02930018|147316808|SUPERIORITY||Odds Ratio (OR)|1.482||||0.088|TWO_SIDED|95.0|0.943|2.329|||Regression, Logistic|||||2.329|0.943|0.088
73892199|NCT02930018|147316808|SUPERIORITY||Absolute Risk Difference (%)|9.1|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
73892200|NCT02930018|147316808|SUPERIORITY||Relative Risk Difference (%)|18.3|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
73892201|NCT02930018|147316809|SUPERIORITY||Odds Ratio (OR)|0.572||||0.055|TWO_SIDED|95.0|0.323|1.013|||Regression, Logistic|||||1.013|0.323|0.055
73892202|NCT02930018|147316809|SUPERIORITY||Absolute Risk Difference (%)|7.5|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
73892203|NCT02930018|147316809|SUPERIORITY||Relative Risk Difference (%)|39.7|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
73892204|NCT02930018|147316810|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.887||||0.529|TWO_SIDED|95.0|0.612|1.286|||Regression, Logistic|||||1.286|0.612|0.529
73892205|NCT02930018|147316811|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.782||||0.181|TWO_SIDED|95.0|0.545|1.121|||Regression, Logistic|||||1.121|0.545|0.181
73892206|NCT02930018|147316812|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.05||||0.869|TWO_SIDED|95.0|0.588|1.874|||Regression, Logistic|||||1.874|0.588|0.869
73892207|NCT03229941|147316854|SUPERIORITY||Odds Ratio (OR)|0.89||||0.515|TWO_SIDED|95.0|0.62|1.27|||Chi-squared||Liberal vs. restrictive arm comparison.|||1.27|0.62|0.515
73892208|NCT03229941|147316855|SUPERIORITY||Odds Ratio (OR)|1.09||||0.587|TWO_SIDED|99.0|0.73|1.61|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.61|0.73|0.587
73892209|NCT03229941|147316856|SUPERIORITY||Odds Ratio (OR)|0.57||||0.007|TWO_SIDED|99.0|0.33|0.98|||Chi-squared||Liberal vs. Restrictive arm comparison|||0.98|0.33|0.007
73892210|NCT03229941|147316857|SUPERIORITY||Odds Ratio (OR)|0.93||||0.634|TWO_SIDED|99.0|0.63|1.38|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.38|0.63|0.634
73892211|NCT03229941|147316858|SUPERIORITY||Odds Ratio (OR)|0.75||||0.212|TWO_SIDED|99.0|0.41|1.37|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.37|0.41|0.212
73892212|NCT03229941|147316859|SUPERIORITY|||||||0.786|||||||Wilcoxon (Mann-Whitney)|||||||0.786
73892213|NCT02255435|147316860|SUPERIORITY||LS Mean difference (Net)|0.1||||0.1524|TWO_SIDED|95.0|-0.04|0.23|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.23|-0.04|0.1524
73892214|NCT02255435|147316860|SUPERIORITY||LS Mean difference (Net)|0.03||||0.7086|TWO_SIDED|95.0|-0.11|0.16|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.16|-0.11|0.7086
73892215|NCT02255435|147316860|SUPERIORITY||LS Mean difference (Net)|-0.13||||0.0651|TWO_SIDED|95.0|-0.26|0.01|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.01|-0.26|0.0651
73892216|NCT02255435|147316860|SUPERIORITY||LS Mean difference (Net)|0.02||||0.7937|TWO_SIDED|95.0|-0.12|0.15|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.15|-0.12|0.7937
73892217|NCT02255435|147316860|SUPERIORITY||LS Mean difference (Net)|-0.04||||0.5587|TWO_SIDED|95.0|-0.18|0.1|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.10|-0.18|0.5587
73892218|NCT02255435|147316860|SUPERIORITY||LS Mean difference (Net)|-0.02||||0.7285|TWO_SIDED|95.0|-0.13|0.09|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.09|-0.13|0.7285
73892219|NCT02255435|147316860|SUPERIORITY||LS Mean difference (Net)|0.03||||0.5802|TWO_SIDED|95.0|-0.09|0.15|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.15|-0.09|0.5802
73892220|NCT02255435|147316860|SUPERIORITY||LS Mean difference (Net)|0.0||||0.9698|TWO_SIDED|95.0|-0.08|0.08|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|Comparison of Omaveloxolone capsules pooled with Placebo capsules||0.08|-0.08|0.9698
73892221|NCT02255435|147316861|SUPERIORITY||LS Mean difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|0.956||0.0141|TWO_SIDED|95.0|-4.31|-0.5|||Mixed Models Analysis|Fixed factors: treatment group, time, interaction between treatment and time, interaction between baseline and time; covariates: site, baseline mFARS|Difference is omaveloxolone - placebo.|||-0.50|-4.31|0.0141
73797227|NCT04856917|147140423|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.74||0.4091|TWO_SIDED|90.0|-3.1|9.3||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||9.30|-3.10|0.4091
73892222|NCT02255435|147316862|SUPERIORITY||LS Mean difference (Net)|-1.81||||0.231|TWO_SIDED|95.0|-4.8|1.18|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||1.18|-4.80|0.2310
73892223|NCT02255435|147316862|SUPERIORITY||LS Mean difference (Net)|-0.52||||0.7298|TWO_SIDED|95.0|-3.51|2.47|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.47|-3.51|0.7298
73892224|NCT02255435|147316862|SUPERIORITY||LS Mean difference (Net)|-0.99||||0.5102|TWO_SIDED|95.0|-3.99|2.0|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.00|-3.99|0.5102
73892225|NCT02255435|147316862|SUPERIORITY||LS Mean difference (Net)|-0.95||||0.5281|TWO_SIDED|95.0|-3.94|2.04|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.04|-3.94|0.5281
73892226|NCT02255435|147316862|SUPERIORITY||LS Mean difference (Net)|-1.42||||0.3458|TWO_SIDED|95.0|-4.42|1.57|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||1.57|-4.42|0.3458
73892227|NCT02255435|147316862|SUPERIORITY||LS Mean difference (Net)|-2.3||||0.0587|TWO_SIDED|95.0|-4.68|0.09|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||0.09|-4.68|0.0587
73892228|NCT02255435|147316862|SUPERIORITY||LS Mean difference (Net)|0.58||||0.648|TWO_SIDED|95.0|-1.94|3.1|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||3.10|-1.94|0.6480
73797228|NCT04856917|147140423|SUPERIORITY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|3.83||0.1274|TWO_SIDED|90.0|-0.47|12.25||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||12.25|-0.47|0.1274
73892229|NCT02255435|147316862|SUPERIORITY||LS Mean difference (Net)|-1.1||||0.2174|TWO_SIDED|95.0|-2.87|0.66|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|Comparison of Omaveloxolone capsules pooled with Placebo capsules||0.66|-2.87|0.2174
73892230|NCT02867384|147316898|SUPERIORITY|||||||0.0008|||||||Fisher Exact|||||||0.0008
73892231|NCT04758637|147317013|SUPERIORITY||Mean Difference (Final Values)|7.62||||0|TWO_SIDED|95.0|2.4|13.59||The calculated p-value is 7.62E-10.|Zero-inflated Poisson mixed regression|Model estimates were used to derive estimated difference in difference value. Confidence intervals were bootstrapped using 1000 repetitions.||Null hypothesis is the difference in difference in estimated mean pill counts from the last week of baseline (week 26) to the last week of the intervention period (week 53) between control and non-fatal is 0.||13.59|2.4|0
73892232|NCT04758637|147317013|SUPERIORITY||Mean Difference (Final Values)|-14.65||||0|TWO_SIDED|95.0|-25.14|-6.97||The calculated p-value is 2E-16.|Zero-inflated Poisson mixed regression|Model estimates were used to derive estimated difference in difference value. Confidence intervals were bootstrapped using 1000 repetitions.||Null hypothesis is the difference in difference in estimated means from the study start (week 0) to the study end (week 23) between control and fatal is 0.||-6.97|-25.14|0
73797229|NCT04856917|147140423|SUPERIORITY||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|3.76||0.2075|TWO_SIDED|90.0|-1.47|11.01||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||11.01|-1.47|0.2075
73892233|NCT04758637|147317014|SUPERIORITY||Slope|0.72||||0.219|TWO_SIDED|95.0|-0.43|1.86|||Regression, Logistic|||||1.86|-0.43|0.219
73892234|NCT04758637|147317014|SUPERIORITY||Slope|-0.72||||0.229|TWO_SIDED|95.0|-1.9|0.46|||Regression, Logistic|||||0.46|-1.9|0.229
73892235|NCT04976192|147317067|OTHER||LS Mean Difference|-0.31|||||TWO_SIDED|95.0|-1.56|0.94||||||||0.94|-1.56|
73892236|NCT04976192|147317068|OTHER||LS Mean Difference|-0.39|||||TWO_SIDED|90.0|-1.37|0.58||||||||0.58|-1.37|
73892237|NCT04976192|147317068|OTHER||Relative Potency|0.89|||||||||||||Relative potency of TEV-45779 and XOLAIR is a co-primary efficacy endpoint for FDA submission.|The relative potency of the test drug to the reference drug was defined as the dose of the test drug that produced the same biological response as 1 unit of the dose of the reference drug. Relative potency was demonstrated if the 90% confidence interval (CI) for relative potency fell entirely within the equivalence margins.||||
73892238|NCT04073225|147317095|SUPERIORITY||Mean Difference (Net)|-33.8||||0.323|TWO_SIDED|95.0|-100.9|33.2|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||33.2|-100.9|.323
73892239|NCT04073225|147317096|SUPERIORITY||Mean Difference (Net)|-81.3||||0.057|TWO_SIDED|95.0|-165.2|2.5|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||2.5|-165.2|.057
73892240|NCT04073225|147317097|SUPERIORITY||Mean Difference (Net)|3.1||||0.047|TWO_SIDED|95.0|0.03|6.08|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||6.08|0.03|.047
73892241|NCT04073225|147317098|SUPERIORITY||Mean Difference (Net)|0.59||||0.565|TWO_SIDED|95.0|-1.4|2.6|||Mixed Models Analysis|||Mixed effects models were fit including fixed effects for intervention arm, visit (baseline, 12 week) and intervention by visit interaction; and random intercepts and slopes for each participant.||2.6|-1.4|.565
73892242|NCT04073225|147317099|SUPERIORITY||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|0.825||0.147|TWO_SIDED|95.0|-0.5|3.03|||t-test, 2 sided|||||3.03|-0.50|0.147
73892243|NCT04073225|147317100|SUPERIORITY||Mean Difference (Net)|99.4||||0.605|TWO_SIDED|95.0|-334.3|533.0|||t-test, 2 sided|||We conducted t-tests of differences in volumetric change comparing intervention to control arms.||533.0|-334.3|.605
73892244|NCT04073225|147317101|SUPERIORITY||Mean Difference (Net)|130.8||||0.59|TWO_SIDED|95.0|-259.7|248.6|||t-test, 2 sided|||We conducted t-tests of differences in volumetric change comparing intervention to control arms.||248.6|-259.7|.590
73892245|NCT04073225|147317102|SUPERIORITY||Mean Difference (Net)|-24.72|STANDARD_ERROR_OF_MEAN|73.85||0.743|TWO_SIDED|95.0|-183.11|133.68|||t-test, 2 sided|||||133.68|-183.11|.743
73892246|NCT04073225|147317103|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|3.13||0.731|TWO_SIDED|95.0|-7.91|5.71|||t-test, 2 sided|||||5.71|-7.91|0.731
73892247|NCT00124306|147317127|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.5|-0.5||||||IC Symptom Index - change from baseline to 12 weeks||-0.5|-2.5|
73892248|NCT00124306|147317127|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-2.3|-0.2||||||IC Problem Index - change from baseline to 12 weeks||-0.2|-2.3|
73892249|NCT00124306|147317127|SUPERIORITY||Mean Difference (Net)|-3.8|||||TWO_SIDED|95.0|-6.3|-1.3||||||Wisconsin Symptom Survey - change from baseline to 12 weeks||-1.3|-6.3|
73892250|NCT02112916|147317130|SUPERIORITY||Hazard Ratio (HR)|0.782||||0.074|TWO_SIDED|95.0|0.561|1.091|||Log Rank||Hazard ratio = hazard rate for Arm B/hazard rate for Arm A|To compare the EFS of the randomized patients (T-ALL+T-LLy) on Arm A vs Arm B. Study was designed to accrue 1200 eligible, evaluable randomized patients (to provide 90.5% power to detect an improvement in 4-year EFS from 85% to 90% with an alpha of 0.05 (one-sided log-rank test) (Hazard Ratio (HR)=0.6483). Study was closed to accrual early due to results from AALL0434 for nelarabine.||1.091|0.561|0.074
73892251|NCT01027806|147317192|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73892252|NCT00943072|147317207|SUPERIORITY_OR_OTHER||Risk Difference (RD)|44.8|||<|0.0001|TWO_SIDED|95.0|33.0|56.6||P-value for the primary endpoint was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (North America vs. Rest of World) and baseline BCVA (BCVA \> 20/200 and BCVA ≤ 20/200)|Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||56.6|33.0|< 0.0001
73892253|NCT00943072|147317208|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.7|||<|0.0001|TWO_SIDED|95.0|17.36|26.04|||ANCOVA||RD is the IAI group minus sham group. 95% confidence interval is for the RD.|||26.04|17.36|< 0.0001
73892254|NCT00943072|147317208|SUPERIORITY_OR_OTHER||Least Square Mean|16.36|||||||||||ANCOVA||LS Mean indicates is the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
73892255|NCT00943072|147317209|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-311.9|||<|0.0001|TWO_SIDED|95.0|-389.4|-234.4|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||-234.4|-389.4|< 0.0001
73892256|NCT00943072|147317209|SUPERIORITY_OR_OTHER||Least Square Mean|-487.1|||||||||||ANCOVA||The Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
73892257|NCT00943072|147317210|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.6||||0.0059|TWO_SIDED|95.0|-12.2|-1.1|||Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||-1.1|-12.2|0.0059
73892258|NCT00943072|147317211|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.26||||0.0009|TWO_SIDED|95.0|2.61|9.91|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||9.91|2.61|0.0009
73892259|NCT00943072|147317211|SUPERIORITY_OR_OTHER||Least Square Mean|8.8|||||||||||ANCOVA||Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
73892260|NCT00662675|147317212|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-fat as a covariate.||The power calculation was based on the assumption that the true mean difference between the active and the placebo group was 31.2% with a common standard deviation of 22.6% using a 2-sided, 2-sample, t-test with a 5% significance level.||||<0.001
73892261|NCT00662675|147317213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-protein(nitrogen) as a covariate.|ANCOVA|||||||<0.001
73797230|NCT04856917|147140423|SUPERIORITY||LS Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|3.77||0.2484|TWO_SIDED|90.0|-1.88|10.64||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||10.64|-1.88|0.2484
73797231|NCT04856917|147140423|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|3.61||0.3399|TWO_SIDED|90.0|-2.53|9.45||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||9.45|-2.53|0.3399
73797232|NCT04856917|147140423|SUPERIORITY||LS Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|3.62||0.0545|TWO_SIDED|90.0|1.03|13.05||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||13.05|1.03|0.0545
73797233|NCT04856917|147140424|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|11.69||0.9679|TWO_SIDED|90.0|-19.86|18.91||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||18.91|-19.86|0.9679
73797234|NCT04856917|147140424|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|11.83||0.9152|TWO_SIDED|90.0|-20.87|18.35||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||18.35|-20.87|0.9152
73797235|NCT04856917|147140424|SUPERIORITY||LS Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|9.64||0.449|TWO_SIDED|90.0|-8.67|23.32||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||23.32|-8.67|0.4490
73797236|NCT04856917|147140424|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|9.74||0.7246|TWO_SIDED|90.0|-12.72|19.6||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||19.60|-12.72|0.7246
73797237|NCT04856917|147140424|SUPERIORITY||LS Mean Difference|13.8|STANDARD_ERROR_OF_MEAN|18.88||0.4655|TWO_SIDED|90.0|-17.49|45.14||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||45.14|-17.49|0.4655
73797238|NCT04856917|147140424|SUPERIORITY||LS Mean Difference|30.5|STANDARD_ERROR_OF_MEAN|19.33||0.1178|TWO_SIDED|90.0|-1.59|62.54||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||62.54|-1.59|0.1178
73797239|NCT04856917|147140424|SUPERIORITY||LS Mean Difference|23.1|STANDARD_ERROR_OF_MEAN|17.71||0.1938|TWO_SIDED|90.0|-6.22|52.52||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||52.52|-6.22|0.1938
73797240|NCT04856917|147140424|SUPERIORITY||LS Mean Difference|29.7|STANDARD_ERROR_OF_MEAN|17.85||0.0991|TWO_SIDED|90.0|0.08|59.29||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||59.29|0.08|0.0991
73797241|NCT04856917|147140424|SUPERIORITY||LS Mean Difference|15.0|STANDARD_ERROR_OF_MEAN|15.44||0.3337|TWO_SIDED|90.0|-10.62|40.59||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||40.59|-10.62|0.3337
73797242|NCT04856917|147140424|SUPERIORITY||LS Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|15.48||0.0465|TWO_SIDED|90.0|5.5|56.87||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||56.87|5.50|0.0465
73892262|NCT04857320|147317242|SUPERIORITY|||||||1.6e-05|||||||ANOVA|Degrees of Freedom = 5||Glucose was monitored by means of a wearable Continuous Glucose Monitor for several days prior to, during and post dosing. Measurements were gathered for each subject and averaged within-subject data. Our null hypothesis was that post prandial serum glucose would not vary significantly from their baseline values.||||0.000016
73892263|NCT04857320|147317243|SUPERIORITY|||||||0|||||||t-test, 1 sided|Degrees of Freedom = 3||Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram on successive days. The Subject's average Serum Glucose for these 3 days were compared against the Subject's baseline unmedicated Serum Glucose on non-dosed days.||||0
73892264|NCT04857320|147317243|SUPERIORITY|||||||3e-06|||||||t-test, 1 sided|||Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram on successive days. The Subject's average Serum Glucose for these 3 days were compared against the Subject's baseline unmedicated Serum Glucose on non-dosed days.||||0.000003
73892265|NCT04857320|147317243|SUPERIORITY|||||||2e-06|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000002
73892266|NCT04857320|147317243|SUPERIORITY|||||||3.5e-05|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000035
73892267|NCT04857320|147317243|SUPERIORITY|||||||4e-06|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000004
73892268|NCT04857320|147317244|SUPERIORITY|||||||0|||||||ANOVA|||||||0
73892269|NCT02563067|147317245|SUPERIORITY||Rate Ratio|0.69||||0.059|TWO_SIDED|95.0|0.5|0.96|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.96|0.50|0.059
73892270|NCT02563067|147317245|SUPERIORITY||Rate Ratio|0.72||||0.114|TWO_SIDED|95.0|0.52|1.01|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.01|0.52|0.114
73892271|NCT02563067|147317246|SUPERIORITY||Mean Difference (Net)|0.15||||0.369|TWO_SIDED|95.0|-0.02|0.32|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.32|-0.02|0.369
73892272|NCT02563067|147317246|SUPERIORITY||Mean Difference (Net)|0.13||||0.824|TWO_SIDED|95.0|-0.04|0.3|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.30|-0.04|0.824
73892273|NCT02563067|147317247|SUPERIORITY||Mean Difference (Net)|-0.17||||0.369|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.01|-0.36|0.369
73892274|NCT02563067|147317247|SUPERIORITY||Mean Difference (Net)|-0.09||||0.824|TWO_SIDED|95.0|-0.28|0.1|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.10|-0.28|0.824
73892275|NCT02563067|147317248|SUPERIORITY||Mean Difference (Net)|0.068||||0.369|TWO_SIDED|95.0|-0.018|0.154|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.154|-0.018|0.369
73892276|NCT02563067|147317248|SUPERIORITY||Mean Difference (Net)|0.038||||0.824|TWO_SIDED|95.0|-0.048|0.124|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.124|-0.048|0.824
73892277|NCT02563067|147317249|SUPERIORITY||Rate Ratio|0.82||||0.369|TWO_SIDED|95.0|0.62|1.07|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.07|0.62|0.369
73892278|NCT02563067|147317249|SUPERIORITY||Rate Ratio|0.76||||0.348|TWO_SIDED|95.0|0.58|1.0|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.00|0.58|0.348
73892279|NCT02563067|147317250|SUPERIORITY||Mean Difference (Net)|0.07||||0.824|TWO_SIDED|95.0|-0.07|0.21|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.21|-0.07|0.824
73892280|NCT02563067|147317250|SUPERIORITY||Mean Difference (Net)|0.12||||0.824|TWO_SIDED|95.0|-0.02|0.26|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.26|-0.02|0.824
73892281|NCT02563067|147317251|SUPERIORITY||Mean Difference (Net)|-0.12||||0.824|TWO_SIDED|95.0|-0.28|0.03|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.03|-0.28|0.824
73797243|NCT04856917|147140425|SUPERIORITY||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|2.95||0.215|TWO_SIDED|90.0|-1.21|8.56||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||8.56|-1.21|0.2150
73797244|NCT04856917|147140425|SUPERIORITY||LS Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|2.97||0.0864|TWO_SIDED|90.0|0.21|10.05||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||10.05|0.21|0.0864
73797245|NCT04856917|147140425|SUPERIORITY||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|3.88||0.0084|TWO_SIDED|90.0|3.97|16.85||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||16.85|3.97|0.0084
73797246|NCT04856917|147140425|SUPERIORITY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.91||0.16|TWO_SIDED|90.0|-0.95|12.01||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||12.01|-0.95|0.1600
73797247|NCT04856917|147140425|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|5.23||0.3671|TWO_SIDED|90.0|-3.94|13.41||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||13.41|-3.94|0.3671
73797248|NCT04856917|147140425|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.35||0.1587|TWO_SIDED|90.0|-1.28|16.46||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||16.46|-1.28|0.1587
73797249|NCT04856917|147140425|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.8||0.1932|TWO_SIDED|90.0|-2.03|17.21||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||17.21|-2.03|0.1932
73797250|NCT04856917|147140425|SUPERIORITY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|5.82||0.2518|TWO_SIDED|90.0|-2.95|16.37||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||16.37|-2.95|0.2518
73797251|NCT04856917|147140425|SUPERIORITY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|5.53||0.232|TWO_SIDED|90.0|-2.53|15.83||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||15.83|-2.53|0.2320
73797252|NCT04856917|147140425|SUPERIORITY||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.55||0.2014|TWO_SIDED|90.0|-2.08|16.35||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||16.35|-2.08|0.2014
73797253|NCT04856917|147140426|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|4.94||0.4361|TWO_SIDED|90.0|-4.34|12.06||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||12.06|-4.34|0.4361
73892282|NCT02563067|147317251|SUPERIORITY||Mean Difference (Net)|-0.07||||0.824|TWO_SIDED|95.0|-0.23|0.08|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.08|-0.23|0.824
73892283|NCT02563067|147317252|SUPERIORITY||Mean Difference (Net)|0.05||||0.369|TWO_SIDED|95.0|-0.019|0.119|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.119|-0.019|0.369
73892284|NCT02563067|147317252|SUPERIORITY||Mean Difference (Net)|0.061||||0.595|TWO_SIDED|95.0|-0.008|0.13|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.130|-0.008|0.595
73892285|NCT00839319|147317254|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|Correlations between serum hormone levels and IT hormones, and between IT hormones were performed on 23 subjects in 4 groups using Spearmen technique.||||||<0.05
73797254|NCT04856917|147140426|SUPERIORITY||LS Mean Difference|8.2|STANDARD_ERROR_OF_MEAN|4.98||0.1018|TWO_SIDED|90.0|-0.04|16.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||16.48|-0.04|0.1018
73892286|NCT04193189|147317358|NON_INFERIORITY|Pre-specified non-inferiority margin (2-CpG minus 3-alum): -10%.|Common proportion difference|12.5|||||TWO_SIDED|97.5|4.1|20.9|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Primary objective of Group A||20.9|4.1|
73892287|NCT04193189|147317358|SUPERIORITY||Common proportion difference|18.4|||||TWO_SIDED|97.5|10.4|26.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe repeated confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Primary objective of Group A||26.2|10.4|
73892288|NCT04193189|147317358|SUPERIORITY||Common proportion difference|6.0|||||TWO_SIDED|97.5|-0.2|11.8|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Secondary objective of Group A||11.8|-0.2|
73892289|NCT04193189|147317360|SUPERIORITY||Common proportion difference|9.0|||||TWO_SIDED|97.5|0.1|18.1|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 4 weeks post last scheduled vaccination (Week 8 in 2-CpG, Week 28 in 3-alum)||18.1|0.1|
73797255|NCT04856917|147140426|SUPERIORITY||LS Mean Difference|16.3|STANDARD_ERROR_OF_MEAN|5.79||0.0059|TWO_SIDED|90.0|6.66|25.88||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||25.88|6.66|0.0059
73892290|NCT04193189|147317360|SUPERIORITY||Common proportion difference|19.0|||||TWO_SIDED|97.5|10.0|27.9|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 12 in 2-CpG, Week 32 in 3-alum)||27.9|10.0|
73892291|NCT04193189|147317360|SUPERIORITY||Common proportion difference|27.8|||||TWO_SIDED|97.5|17.7|37.2|||||Common SP proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 28 in 2-CpG, Week 48 in 3-alum)||37.2|17.7|
73797256|NCT04856917|147140426|SUPERIORITY||LS Mean Difference|9.9|STANDARD_ERROR_OF_MEAN|5.83||0.0913|TWO_SIDED|90.0|0.26|19.59||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||19.59|0.26|0.0913
73797257|NCT04856917|147140426|SUPERIORITY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|7.7||0.4921|TWO_SIDED|90.0|-7.47|18.09||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||18.09|-7.47|0.4921
73797258|NCT04856917|147140426|SUPERIORITY||LS Mean Difference|11.1|STANDARD_ERROR_OF_MEAN|7.89||0.1607|TWO_SIDED|90.0|-1.95|24.24||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||24.24|-1.95|0.1607
73797259|NCT04856917|147140426|SUPERIORITY||LS Mean Difference|14.2|STANDARD_ERROR_OF_MEAN|9.19||0.1244|TWO_SIDED|90.0|-1.02|29.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||29.48|-1.02|0.1244
73797260|NCT04856917|147140426|SUPERIORITY||LS Mean Difference|15.2|STANDARD_ERROR_OF_MEAN|9.2||0.1004|TWO_SIDED|90.0|-0.02|30.51||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||30.51|-0.02|0.1004
73892292|NCT04193189|147317360|SUPERIORITY||Common proportion difference|32.3|||||TWO_SIDED|97.5|21.3|42.3|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 52 in 2-CpG, Week 72 in 3-alum)||42.3|21.3|
73797261|NCT04856917|147140426|SUPERIORITY||LS Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|9.64||0.2015|TWO_SIDED|90.0|-3.61|28.39||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||28.39|-3.61|0.2015
73892293|NCT04193189|147317360|SUPERIORITY||Common proportion difference|23.8|||||TWO_SIDED|97.5|15.5|32.3|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 32)||32.3|15.5|
73892294|NCT04193189|147317360|SUPERIORITY||Common proportion difference|32.3|||||TWO_SIDED|97.5|23.2|41.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 48)||41.2|23.2|
73892295|NCT04193189|147317360|SUPERIORITY||Common proportion difference|38.8|||||TWO_SIDED|97.5|28.9|48.1|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 72)||48.1|28.9|
73797262|NCT04856917|147140426|SUPERIORITY||LS Mean Difference|15.8|STANDARD_ERROR_OF_MEAN|9.66||0.1057|TWO_SIDED|90.0|-0.27|31.81||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||31.81|-0.27|0.1057
73797263|NCT04856917|147140427|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.08||0.5157|TWO_SIDED|90.0|-0.08|0.19||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||0.19|-0.08|0.5157
73892296|NCT04193189|147317360|SUPERIORITY||Common proportion difference|10.0|||||TWO_SIDED|97.5|3.1|16.4|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 4 weeks post last scheduled vaccination (Week 28 in 3-CpG, Week 8 in 2-CpG)||16.4|3.1|
73892297|NCT04193189|147317360|SUPERIORITY||Common proportion difference|4.8|||||TWO_SIDED|97.5|-0.8|10.5|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 8 weeks post last scheduled vaccination (Week 32 in 3-CpG, Week 12 in 2-CpG)||10.5|-0.8|
73892298|NCT04193189|147317360|SUPERIORITY||Common proportion difference|4.9|||||TWO_SIDED|97.5|-0.8|11.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 24 weeks post last scheduled vaccination (Week 48 in 3-CpG, Week 28 in 2-CpG)||11.2|-0.8|
73892299|NCT04193189|147317360|SUPERIORITY||Common proportion difference|7.2|||||TWO_SIDED|97.5|0.7|14.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 48 weeks post last scheduled vaccination (Week 72 in 3-CpG, Week 52 in 2-CpG)||14.2|0.7|
73892300|NCT02685267|147317365|OTHER|The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.|log-rank test|0.6761||||0.6761|TWO_SIDED|95.0|||||Chi-squared|||The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.||||0.6761
73892301|NCT02840799|147317371|SUPERIORITY||Mean Difference (Final Values)|-0.1309108|STANDARD_ERROR_OF_MEAN|0.2619326||0.6191|TWO_SIDED|95.0|-0.6552259|0.3934043||A two-sided α=0.05 was determined by the power calculation.|t-test, 2 sided|t = -0.49979, df = 58. N=59 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossovered.|Only participants that successfully crossed over were included in the t-test (N=59).|We considered an increase in peak VO2 of \~0.6 ml/kg/min to be the minimum clinically significant change. Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints with a two-sided α=0.05. PASS11157 was used to perform power calculations.||0.3934043|-0.6552259|0.6191
73892302|NCT02840799|147317371|SUPERIORITY||Slope|0.1||||0.711|TWO_SIDED|95.0|-0.043|0.62||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.62|-.043|0.711
73892303|NCT02840799|147317372|SUPERIORITY||Mean Difference (Final Values)|2.217657|STANDARD_ERROR_OF_MEAN|2.065196||0.2871|TWO_SIDED|95.0|-1.910612|6.3459261|||t-test, 2 sided|t = 1.0738, df = 62, p-value = 0.2871, N=63 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossovered.||A two-sided α=0.05 was determined by the power calculation.||6.3459261|-1.910612|0.2871
73797264|NCT04856917|147140427|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0178|TWO_SIDED|90.0|0.06|0.34||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||0.34|0.06|0.0178
73892304|NCT02840799|147317372|SUPERIORITY||Slope|-2.12||||0.2935|TWO_SIDED|95.0|-6.12|1.88||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect. Randomization sequence was not included in the final model due to lack of evidence for a carry over effect. Phase 1 data for participants that did not crossover due to IDS were considered for the model (N=74).||1.88|-6.12|0.2935
73892305|NCT02840799|147317373|SUPERIORITY||Mean Difference (Final Values)|2.1859922|STANDARD_ERROR_OF_MEAN|1.578944||0.171|TWO_SIDED|95.0|-0.9674467|5.3392901||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=1.3844, df=65, p=0.171. N=66 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossover correctly.||||5.3392901|-0.9674467|0.171
73892306|NCT02840799|147317373|SUPERIORITY||Slope|-2.51||||0.113|TWO_SIDED|95.0|-5.62|0.61||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.61|-5.62|0.113
73892307|NCT02840799|147317374|SUPERIORITY||Mean Difference (Final Values)|2.776572|STANDARD_ERROR_OF_MEAN|3.99464||0.4905|TWO_SIDED|95.0|-5.264221|10.817366||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t = 0.69507, df=46, p=.4905. N=47 due to only analyzed participants that correctly crossovered.||||10.817366|-5.264221|0.4905
73892308|NCT02840799|147317374|SUPERIORITY||Slope|1.088||||0.796|TWO_SIDED|95.0|-7.3|9.48||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||9.48|-7.30|0.796
73892309|NCT02840799|147317375|SUPERIORITY||Mean Difference (Final Values)|-38.11189|STANDARD_ERROR_OF_MEAN|43.84245||0.4017|TWO_SIDED|95.0|-133.63637|57.41259|||t-test, 2 sided|t=-0.86929,, df=12, p=0.4017||||57.41259|-133.63637|0.4017
73892310|NCT02840799|147317375|SUPERIORITY||Slope|61.77||||0.183|TWO_SIDED|95.0|-34.15|157.69||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||157.69|-34.15|0.183
73892311|NCT02840799|147317376|SUPERIORITY||Mean Difference (Final Values)|0.202782|STANDARD_ERROR_OF_MEAN|0.202782||0.5636|TWO_SIDED|95.0|-0.4959279|0.9014918||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=0.58074, df=59, p=0.5636||||0.9014918|-0.4959279|0.5636
73892312|NCT02840799|147317376|SUPERIORITY||Slope|-0.3118||||0.361|TWO_SIDED|95.0|-0.99|0.37||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.37|-0.99|0.361
73892313|NCT02840799|147317377|SUPERIORITY||Mean Difference (Final Values)|-0.1532142|STANDARD_ERROR_OF_MEAN|-0.1532142||0.7707|TWO_SIDED|95.0|-1.1998786|0.8934502||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t= -0.29271, df=61, p=0.7707||||0.8934502|-1.1998786|0.7707
73892314|NCT02840799|147317377|SUPERIORITY||Slope|0.18872||||0.724|TWO_SIDED|95.0|-0.88|1.25||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||1.25|-0.88|0.724
73892315|NCT02840799|147317378|SUPERIORITY||Mean Difference (Final Values)|0.3262821|STANDARD_ERROR_OF_MEAN|0.2333465||0.1680825|TWO_SIDED|95.0|-0.1421806|0.7947447||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=1.3983, df=51, p=0.1681||||0.7947447|-0.1421806|0.1680825
73892316|NCT02840799|147317378|SUPERIORITY||Slope|-0.4082||||0.093|TWO_SIDED|95.0|-0.88|0.07||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||0.07|-0.88|0.0930
73892317|NCT02840799|147317379|SUPERIORITY||Mean Difference (Final Values)|-2.116437|STANDARD_ERROR_OF_MEAN|1.176768||0.07984|TWO_SIDED|95.0|-4.4966754|0.2638017||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided||t = -1.7985, df=39, p=0.07984|||0.2638017|-4.4966754|0.07984
73892318|NCT02840799|147317379|SUPERIORITY||Slope|1.68||||0.135|TWO_SIDED|95.0|-0.54|3.9||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||3.90|-0.54|0.135
73892319|NCT02840799|147317380|SUPERIORITY||Mean Difference (Final Values)|-0.0192733|STANDARD_ERROR_OF_MEAN|0.01295984||0.145|TWO_SIDED|95.0|-0.0454871|0.0069404||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|||||0.00694040|-0.0454871|0.1450
73892320|NCT02840799|147317380|SUPERIORITY||Slope|0.01324||||0.3047|TWO_SIDED|95.0|-0.01|0.04||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||0.04|-0.01|0.3047
73892321|NCT02840799|147317381|SUPERIORITY||Mean Difference (Final Values)|-3.506681|STANDARD_ERROR_OF_MEAN|4.494971||0.44|TWO_SIDED|95.0|-12.598617|5.585256||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|||||5.585256|-12.598617|0.44
73892322|NCT02840799|147317381|SUPERIORITY||Slope|3.39106||||0.39911|TWO_SIDED|95.0|-4.66|11.44||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||11.44|-4.66|0.39911
73892323|NCT00552188|147317401|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|95.0|||||ANCOVA|||ANCOVA model adjusted for baseline value||||0.34
73892324|NCT00552188|147317402|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|95.0|||||ANCOVA|||ANCOVA model adjusted for baseline||||0.15
73892325|NCT00689260|147317409|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||Wilcoxon (Mann-Whitney)|||P-Value based on two-sided Wilcoxon rank-sum test for difference in medians between log aware and log unaware||||0.908
73892326|NCT01621802|147317459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: Lower limit (LL) of the 2-sided 97.5% confidence interval (CI) for group difference (Inv\_MMR\_CO Group minus pooled Com\_MMR\_CO Group) in seroresponse rates to measles, mumps and rubella viruses is ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.72|1.98|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.98|-0.72|
73892327|NCT01621802|147317459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.71|||||TWO_SIDED|97.5|0.02|2.97|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-Measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||2.97|0.02|
73797265|NCT04856917|147140427|SUPERIORITY||LS Mean Difference|0.3|STANDARD_DEVIATION|0.12||0.0132|TWO_SIDED|90.0|0.1|0.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||0.48|0.10|0.0132
73797266|NCT04856917|147140427|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0034|TWO_SIDED|90.0|0.16|0.54||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||0.54|0.16|0.0034
73797267|NCT04856917|147140427|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.051|TWO_SIDED|90.0|0.04|0.47||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||0.47|0.04|0.0510
73892328|NCT01621802|147317460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_CO Group minus pooled Com\_MMR\_CO Group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.72|1.97|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.97|-0.72|
73892329|NCT01621802|147317460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.68|1.75|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||1.75|-0.68|
73892330|NCT01621802|147317461|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_CO group minus pooled Com\_MMR\_CO group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|-0.14|||||TWO_SIDED|97.5|-0.98|1.84|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.84|-0.98|
73892331|NCT01621802|147317461|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.68|1.75|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||1.75|-0.68|
73892332|NCT01621802|147317462|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.99|||||TWO_SIDED|97.5|0.92|1.06|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.06|0.92|
73892333|NCT01621802|147317462|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||TWO_SIDED|97.5|0.96|1.1|||ANCOVA|Ancova model: adjustment for baseline concentration country - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.10|0.96|
73892334|NCT01621802|147317463|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.91|||||TWO_SIDED|97.5|0.83|1.0|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.00|0.83|
73797268|NCT04856917|147140427|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0608|TWO_SIDED|90.0|0.03|0.47||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||0.47|0.03|0.0608
73797269|NCT04856917|147140427|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2702|TWO_SIDED|90.0|-0.1|0.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||0.48|-0.10|0.2702
73797270|NCT04856917|147140427|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0249|TWO_SIDED|90.0|0.11|0.69||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||0.69|0.11|0.0249
73797271|NCT04856917|147140427|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1853|TWO_SIDED|90.0|-0.06|0.55||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||0.55|-0.06|0.1853
73797272|NCT04856917|147140427|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.2974|TWO_SIDED|90.0|-0.11|0.5||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||0.50|-0.11|0.2974
73797273|NCT04856917|147140428|SUPERIORITY||Risk Difference (RD)|-2.5||||0.339|TWO_SIDED|90.0|-6.62|1.63||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 4||1.63|-6.62|0.3390
73797274|NCT04856917|147140428|SUPERIORITY||Risk Difference (RD)|-2.6||||0.3243|TWO_SIDED|90.0|-6.79|1.59||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 4||1.59|-6.79|0.3243
73892335|NCT01621802|147317463|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.96|||||TWO_SIDED|97.5|0.87|1.06|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.06|0.87|
73797275|NCT04856917|147140428|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-5.91|5.91||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 8||5.91|-5.91|1.0000
73892336|NCT01621802|147317464|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||TWO_SIDED|97.5|0.97|1.09|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|Adjusted geometric mean concentration (GMC) ratio (Inv\_MMR\_CO group divided by Com\_MMR\_CO group) for antibodies to rubella virus.||1.09|0.97|
73892337|NCT01621802|147317464|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.01|||||TWO_SIDED|97.5|0.95|1.07|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.07|0.95|
73892338|NCT01149148|147317488|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3333|STANDARD_DEVIATION|1.626||0.678|TWO_SIDED|95.0|-1.36|2.02||A prior threshold for statistical significance is p \< 0.05|t-test, 2 sided||The difference between baseline and three months is (baseline - 3 month). The difference in control and intervention is (intervention - control), which in this case is (unblinded - blinded).|The goal was to determine whether cerebral oximetry monitoring during surgery affected cognitive outcomes. Cerebral Oximetry Monitoring unblinded (intervention), and Cerebral Oxymetry Monitoring blinded (control) were given Mini Mental State Exam prior to surgery and three months after surgery. The differences between baseline and 3 month were calculated and compared between the intervention and control groups using t-test.||2.02|-1.36|0.678
73892339|NCT03436082|147317490|OTHER|We used Stata version 14.2 (StataCorp LP) to perform chi-square tests to compare syncing of the Fitbit device and response rate for the postprocedure recovery PROMs and disease-specific PROMs between patients in the bariatric surgery and atrial fibrillation ablation groups, using a p value \< 0.05 to denote statistical significance.||||||0.04|||||||Chi-squared|||||||0.04
73892340|NCT03436082|147317492|OTHER|We used Stata version 14.2 (StataCorp LP) to perform chi-square tests to compare syncing of the Fitbit device and response rate for the postprocedure recovery PROMs and disease-specific PROMs between patients in the bariatric surgery and atrial fibrillation ablation groups, using a p value \< 0.05 to denote statistical significance.||||||0.85|||||||Chi-squared|||||||0.85
73892341|NCT00950859|147317495|SUPERIORITY_OR_OTHER||percentage of participants|78.0|||||TWO_SIDED|95.0|58.0|91.0|||||The estimated value represents the percentage of participants with HIV-1 RNA \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.|||91|58|
73892342|NCT00950859|147317495|SUPERIORITY_OR_OTHER||percentage of participants|96.0||||||95.0|79.0|100.0|||||The estimated value represents the percentage of participants with HIV-1 RNA \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.|||100|79|
73892343|NCT02917642|147317521|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of bacteria within the root canal system.||||0.04
73892344|NCT02917642|147317522|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of endotoxin within the root canal system.||||0.94
73892345|NCT02249832|147317523|EQUIVALENCE|A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).|||||<|0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA|||||||<0.001
73892346|NCT02249832|147317524|EQUIVALENCE|A significance level of 0.05 was used (two-sided).|||||<|0.001|||||||ANOVA|||A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).||||<0.001
73892347|NCT02249832|147317525|EQUIVALENCE|A 3x3 repeated measures ANOVA was performed with group (mean distance walked in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).||||||0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.001
73892348|NCT00243269|147317541|SUPERIORITY_OR_OTHER|||||||0.932||95.0|||||ANOVA|||The primary analyses consisted of calculating means and standard deviations on nausea for the four study arms to generate an effect size estimate for a later R01. We also planned to use a 2 x 2 (i.e., two levels of expectancy CDs and two levels of expectancy handouts) full factorial analysis of variance (ANOVA) to examine the efficacy of these two methods of expectancy enhancement in reducing Average Nausea as well as any interaction effects.||||0.932
73892349|NCT00243269|147317542|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANOVA|||ANOVA to compare means of the four groups was used.||||0.84
73892350|NCT04661579|147317567|OTHER||Vaccine Efficacy|35.9||||0.009|TWO_SIDED|95.0|10.3|54.2|||Wald test||Vaccine efficacy (VE) is defined as the percent reduction in the hazard, i.e. one minus the hazard ratio (HR, RTS,S/AS01E Vaccine vs. Rabies vaccine).|Vaccine efficacy against the first PCR-positive P. falciparum infection among adults who were P. falciparum positive at baseline was assessed using Cox proportional hazards regression model with a covariate for group assignment to compare Groups 1 and 4. HIV status, Age (tertiles), and sleep under a bednet were included as covariates.||54.2|10.3|0.009
73892351|NCT04661579|147317568|OTHER||Vaccine Efficacy|-24.0||||0.369|TWO_SIDED|95.0|-97.0|22.2|||Wald test||Vaccine efficacy (VE) is defined as the percent reduction in the hazard, i.e. one minus the hazard ratio (HR, RTS,S/AS01E Vaccine vs. Rabies vaccine).|Vaccine efficacy against the first PCR-positive P. falciparum infection among adults who were P. falciparum positive at baseline was assessed using Cox proportional hazards regression model with a covariate for group assignment to compare Groups 2 and 5. HIV status, Age (tertiles), and sleep under a bednet were included as covariates.||22.2|-97|0.369
73892352|NCT02910986|147317626|SUPERIORITY||||||>|0.05|||||||Chi-squared|||The percentage with improved knowledge (defined as having an incorrect response at T0 and a correct response at T1) was compared between study groups with chi-square tests.||||> 0.05
73892353|NCT02910986|147317627|SUPERIORITY|||||||0.56||||||The priori threshold for statistical significance was 0.05|Chi-squared|||||||0.56
73892354|NCT02910986|147317628|SUPERIORITY||||||>|0.05||||||The priori threshold for statistical significance was 0.05.|Chi-squared|||||||> 0.05
73892355|NCT02910986|147317628|OTHER||difference between EC and UC|2.6|||||TWO_SIDED|98.3|-6.0|11.2||||||||11.2|-6.0|
73892356|NCT02910986|147317628|OTHER||difference between INT and UC|5.0|||||TWO_SIDED|98.3|-4.3|14.3||||||||14.3|-4.3|
73892357|NCT02910986|147317628|OTHER||difference between INT and ENH|2.4|||||TWO_SIDED|98.3|-7.0|11.9||||||||11.9|-7.0|
73892358|NCT02280408|147317643|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
73892359|NCT02280408|147317643|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
73892360|NCT02280408|147317643|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
73892361|NCT02280408|147317643|OTHER|||||||0.01|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.010
73892362|NCT02280408|147317643|OTHER|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.011
73892363|NCT02280408|147317643|OTHER|||||||0.969|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||0.969
73892364|NCT02280408|147317644|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
73892365|NCT02280408|147317644|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
73892366|NCT02280408|147317644|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
73892367|NCT02280408|147317644|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
73892368|NCT02280408|147317644|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
73892369|NCT02280408|147317644|OTHER|||||||0.733|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||0.733
73892370|NCT02280408|147317645|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
73892371|NCT02280408|147317645|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
73892372|NCT02280408|147317645|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
73892373|NCT02280408|147317645|OTHER|||||||0.132|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.132
73892374|NCT02280408|147317645|OTHER|||||||0.07|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.070
73892375|NCT02280408|147317645|OTHER|||||||0.743|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.743
73892376|NCT02280408|147317646|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
73892377|NCT02280408|147317646|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
73892378|NCT02280408|147317646|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
73892379|NCT02280408|147317646|OTHER|||||||0.014|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.014
73892380|NCT02280408|147317646|OTHER|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.011
73892381|NCT02280408|147317646|OTHER|||||||0.923|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.923
73892382|NCT02474069|147317651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.087|TWO_SIDED|95.0|0.39|1.07|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error||1.07|0.39|0.087
73797276|NCT04856917|147140428|SUPERIORITY||Risk Difference (RD)|-2.66||||0.332|TWO_SIDED|90.0|-6.96|1.63||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 8||1.63|-6.96|0.3320
73892383|NCT02474069|147317652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.281|TWO_SIDED|95.0|0.43|1.28|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error||1.28|0.43|0.281
73892384|NCT04173494|147317663|SUPERIORITY||Stratified Cochran-Mantel-Haenszel|15.67||||0.0095|TWO_SIDED|95.0|5.54|25.81|||Cochran-Mantel-Haenszel|||||25.81|5.54|0.0095
73892385|NCT04173494|147317664|NON_INFERIORITY|If the lower bound of the confidence interval (CI) is greater than 0, MMB was to be declared non-inferior to DAN.|Non-inferiority difference|13.58||||0.0116|TWO_SIDED|95.0|1.86|25.3|||Cochran-Mantel-Haenszel||Non-inferiority difference, defined as p(MMB) - (0.8) \*p(DAN) where p(MMB) is percentage of participants with TI status in MMB arm and p(DAN) is percentage of participants with TI status in DAN arm.|||25.30|1.86|0.0116
73892386|NCT04173494|147317665|OTHER||Stratified Cochran-Mantel-Haenszel|33.05|||<|0.0001|TWO_SIDED|95.0|22.59|43.51|||Cochran-Mantel-Haenszel|||||43.51|22.59|< 0.0001
73892387|NCT04173494|147317666|OTHER||Least Squares Mean Difference|-6.22||||0.0014|TWO_SIDED|95.0|-10.0|-2.43|||mixed model for repeated measures (MMRM)|||||-2.43|-10.0|0.0014
73892388|NCT04173494|147317667|OTHER||Stratified Cochran-Mantel-Haenszel|18.18||||0.0011|TWO_SIDED|95.0|9.77|26.59|||Cochran-Mantel-Haenszel|||||26.59|9.77|0.0011
73892389|NCT04173494|147317668|OTHER||Stratified Cochran-Mantel-Haenszel|17.2||||0.0012|TWO_SIDED|95.0|7.99|26.4|||Cochran-Mantel-Haenszel|||||26.40|7.99|0.0012
73892390|NCT04173494|147317669|OTHER||Stratified Cochran-Mantel-Haenszel|10.62||||0.1133|TWO_SIDED|95.0|-2.4|23.64|||Cochran-Mantel-Haenszel|||||23.64|-2.40|0.1133
73892391|NCT04173494|147317672|OTHER||Hazard Ratio (HR)|0.556||||0.0006|TWO_SIDED|95.0|0.397|0.778|||Anderson & Gill proportional means model|||||0.778|0.397|0.0006
73892392|NCT04173494|147317673|OTHER||Stratified CMH|-8.26||||0.1602|TWO_SIDED|95.0|-20.18|3.66|||Cochran-Mantel-Haenszel|||||3.66|-20.18|0.1602
73892393|NCT04173494|147317674|OTHER||Stratified CMH|19.0||||0.0124|TWO_SIDED|95.0|4.68|33.32|||Cochran-Mantel-Haenszel||\>=1g/dL Increase in Hemoglobin response|||33.32|4.68|0.0124
73892394|NCT04173494|147317674|OTHER||Stratified CMH|15.68||||0.0282|TWO_SIDED|95.0|2.47|28.9|||Cochran-Mantel-Haenszel||\>=1.5g/dL Increase in Hemoglobin response|||28.90|2.47|0.0282
73892395|NCT04173494|147317674|OTHER||Stratified CMH|6.97||||0.2844|TWO_SIDED|95.0|-5.41|19.35|||Cochran-Mantel-Haenszel||\>=2g/dL Increase in Hemoglobin response|||19.35|-5.41|0.2844
73892396|NCT04173494|147317679|OTHER||Hazard Ratio (HR)|0.89||||0.6879|TWO_SIDED|95.0|0.504|1.572|||Log Rank|||||1.572|0.504|0.6879
73892397|NCT04173494|147317680|OTHER||Hazard Ratio (HR)|0.804||||0.432|TWO_SIDED|95.0|0.466|1.386|||Log Rank|||||1.386|0.466|0.4320
73892398|NCT04173494|147317681|OTHER||Least Squares Mean Difference|-0.71||||0.0513|TWO_SIDED|95.0|-1.42|0.0|||MMRM|||||0.00|-1.42|0.0513
73892399|NCT04173494|147317682|OTHER||Least Squares Mean Difference|-10.82||||0.0113|TWO_SIDED|95.0|-19.15|-2.48|||MMRM|||||-2.48|-19.15|0.0113
73892400|NCT04173494|147317683|OTHER||Least Squares Mean Difference|1.31||||0.357|TWO_SIDED|95.0|-1.49|4.11|||MMRM|||||4.11|-1.49|0.3570
73892401|NCT03656380|147317684|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
73892402|NCT03656380|147317685|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
73892403|NCT03656380|147317686|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.20
73892404|NCT03656380|147317687|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73892405|NCT03656380|147317688|SUPERIORITY||||||<|0.001|||||||Chi-squared|||\<15 eos/hpf||||<0.001
73892406|NCT03656380|147317688|SUPERIORITY|||||||0.02|||||||Chi-squared|||≤6 eos/hpf||||0.02
73892407|NCT03656380|147317688|SUPERIORITY|||||||0.27|||||||Chi-squared|||≤1 eos/hpf||||0.27
73892408|NCT03656380|147317689|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
73892409|NCT03656380|147317690|SUPERIORITY|||||||0.44|||||||ANCOVA|||||||0.44
73892410|NCT00838513|147317703|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|80.0|||||TWO_SIDED|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS."||94|56|
73892411|NCT00838513|147317704|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
73892412|NCT00838513|147317705|SUPERIORITY_OR_OTHER||Percent of complete TMA response|25.0|||||TWO_SIDED|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||49|9|
73892413|NCT00838513|147317706|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
73797277|NCT04856917|147140428|SUPERIORITY||Risk Difference (RD)|-2.45||||0.7595|TWO_SIDED|90.0|-15.5|10.59||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 12||10.59|-15.50|0.7595
73797278|NCT04856917|147140428|SUPERIORITY||Risk Difference (RD)|-14.11||||0.0209|TWO_SIDED|90.0|-23.66|-4.57||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 12||-4.57|-23.66|0.0209
73797279|NCT04856917|147140428|SUPERIORITY||Risk Difference (RD)|-4.56||||0.6094|TWO_SIDED|90.0|-18.99|9.87||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 20||9.87|-18.99|0.6094
73797280|NCT04856917|147140428|SUPERIORITY||Risk Difference (RD)|-10.28||||0.2076|TWO_SIDED|90.0|-23.34|2.78||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 20||2.78|-23.34|0.2076
73797281|NCT04856917|147140429|SUPERIORITY||Risk Difference (RD)|0.1||||0.4482|TWO_SIDED|90.0|-0.1|0.29||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 2||0.29|-0.10|0.4482
73797282|NCT04856917|147140429|SUPERIORITY||Risk Difference (RD)|0.14||||0.4529|TWO_SIDED|90.0|-0.05|0.33||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.33|-0.05|0.4529
73797283|NCT04856917|147140429|SUPERIORITY||Risk Difference (RD)|-0.01||||0.932|TWO_SIDED|90.0|-0.2|0.18||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 4||0.18|-0.20|0.9320
73797284|NCT04856917|147140429|SUPERIORITY||Risk Difference (RD)|-0.03||||0.3151|TWO_SIDED|90.0|-0.22|0.16||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 4||0.16|-0.22|0.3151
73797285|NCT04856917|147140429|SUPERIORITY||Risk Difference (RD)|-0.14||||0.2908|TWO_SIDED|90.0|-0.32|0.06||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 8||0.06|-0.32|0.2908
73797286|NCT04856917|147140429|SUPERIORITY||Risk Difference (RD)|0.05||||0.7277|TWO_SIDED|90.0|-0.15|0.24||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 8||0.24|-0.15|0.7277
73797287|NCT04856917|147140429|SUPERIORITY||Risk Difference (RD)|-0.03||||0.8463|TWO_SIDED|90.0|-0.23|0.17||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 12||0.17|-0.23|0.8463
73797288|NCT04856917|147140429|SUPERIORITY||Risk Difference (RD)|-0.08||||0.5281|TWO_SIDED|90.0|-0.28|0.11||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 12||0.11|-0.28|0.5281
73797289|NCT04856917|147140429|SUPERIORITY||Risk Difference (RD)|-0.09||||0.5747|TWO_SIDED|90.0|-0.28|0.11||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 20||0.11|-0.28|0.5747
73797290|NCT04856917|147140429|SUPERIORITY||Risk Difference (RD)|-0.05||||0.5081|TWO_SIDED|90.0|-0.24|0.14||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 20||0.14|-0.24|0.5081
73797291|NCT04856917|147140430|SUPERIORITY||Risk Difference (RD)|0.01||||0.8338|TWO_SIDED|90.0|-0.19|0.2||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 2||0.20|-0.19|0.8338
73797292|NCT04856917|147140430|SUPERIORITY||Risk Difference (RD)|-0.12||||0.1142|TWO_SIDED|90.0|-0.31|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.09|-0.31|0.1142
73797293|NCT04856917|147140430|SUPERIORITY||Risk Difference (RD)|-0.2||||0.3433|TWO_SIDED|90.0|-0.38|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 4||0.00|-0.38|0.3433
73797294|NCT04856917|147140430|SUPERIORITY||Risk Difference (RD)|-0.17||||0.1129|TWO_SIDED|90.0|-0.37|0.04||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.04|-0.37|0.1129
73797295|NCT04856917|147140430|SUPERIORITY||Risk Difference (RD)|-0.2||||0.2842|TWO_SIDED|90.0|-0.38|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 8||0.00|-0.38|0.2842
73797296|NCT04856917|147140430|SUPERIORITY||Risk Difference (RD)|-0.34||||0.0212|TWO_SIDED|90.0|-0.52|-0.13||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 8||-0.13|-0.52|0.0212
73892414|NCT00838513|147317707|SUPERIORITY_OR_OTHER||LS mean change from baseline|6.75||||0.5423|TWO_SIDED|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||29.23|-15.73|0.5423
73892415|NCT00838513|147317708|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
73892416|NCT00838513|147317709|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|95.0|||||TWO_SIDED|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||100|75|
73892417|NCT00838513|147317710|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
73892418|NCT00838513|147317711|SUPERIORITY_OR_OTHER||Percent of complete TMA response|55.0|||||TWO_SIDED|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||77|32|
73892419|NCT00838513|147317712|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
73892420|NCT00838513|147317713|SUPERIORITY_OR_OTHER||LS mean change from baseline|-3.68||||0.7307|TWO_SIDED|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||17.79|-25.15|0.7307
73892421|NCT00838513|147317714|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
73892422|NCT01594528|147317716|OTHER|||||||0.992||||||comparison between groups for body indicators|Wilcoxon (Mann-Whitney)|||||||0.992
73892423|NCT01594528|147317716|OTHER|||||||0.8||||||comparison between groups facial indicators|Wilcoxon (Mann-Whitney)|||||||0.8
73892424|NCT01594528|147317716|OTHER|||||||0.586||||||comparison between groups for vocal indicators|Wilcoxon (Mann-Whitney)|||||||0.586
73797297|NCT04856917|147140430|SUPERIORITY||Risk Difference (RD)|-0.07||||0.7665|TWO_SIDED|90.0|-0.28|0.14||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 12||0.14|-0.28|0.7665
73797298|NCT04856917|147140430|SUPERIORITY||Risk Difference (RD)|-0.22||||0.1777|TWO_SIDED|90.0|-0.42|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 12||-0.00|-0.42|0.1777
73892425|NCT01388335|147317723|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.81|||||TWO_SIDED|90.0|0.691|0.95|||||Ratio of Geometric LS mean is for S-warfarin.|||0.950|0.691|
73892426|NCT01388335|147317723|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.912|||||TWO_SIDED|90.0|0.815|1.02|||||Ratio of Geometric LS mean is for R-warfarin.|||1.02|0.815|
73892427|NCT01388335|147317724|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.98|||||TWO_SIDED|90.0|0.76|3.5|||||Median Difference (Final Values) is for S-warfarin.|||3.50|0.76|
73892428|NCT01388335|147317724|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.5|||||TWO_SIDED|90.0|-1.0|6.84|||||Median Difference (Final Values) is for R-warfarin.|||6.84|-1.00|
73892429|NCT01388335|147317725|SUPERIORITY_OR_OTHER_LEGACY||Ratio|1.28|||||TWO_SIDED|90.0|1.14|1.44|||||Ratio of Geometric LS mean is for S-warfarin.|||1.44|1.14|
73892430|NCT01388335|147317725|SUPERIORITY_OR_OTHER_LEGACY||Ratio|1.26|||||TWO_SIDED|90.0|1.08|1.47|||||Ratio of Geometric LS mean is for R-warfarin.|||1.47|1.08|
73892431|NCT01388335|147317730|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.92|||||TWO_SIDED|90.0|0.86|1.0|||||Ratio of Geometric LS mean.|||1.00|0.86|
73892432|NCT01388335|147317731|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.98|||||TWO_SIDED|90.0|0.95|1.02|||||Ratio of Geometric LS mean.|||1.02|0.95|
73892433|NCT01388335|147317734|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric LS Mean|1.03||||||90.0|0.99|1.08|||||Ratio of Geometric LS mean for Period 2, Day 14, 0 hours.|||1.08|0.99|
73892434|NCT01388335|147317734|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric LS Means|1.02|||||TWO_SIDED|90.0|0.98|1.06|||||Ratio of Geometric LS mean for Period 2, Day 14, 4 hours.|||1.06|0.98|
73892435|NCT00670306|147317757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6|STANDARD_DEVIATION|7.1|<|0.001|||||||t-test, 2 sided|||||||<0.001
73892436|NCT03904693|147317762|SUPERIORITY||Geometric Mean Ratio|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.82|||ANCOVA|||||0.82|0.61|<0.0001
73892437|NCT03904693|147317762|SUPERIORITY||Geometric Mean Ratio|0.72|||<|0.0001|TWO_SIDED|95.0|0.64|0.8|||ANCOVA|||||0.80|0.64|<0.0001
73892438|NCT02100696|147317767|SUPERIORITY||Adjusted difference in response rates|12.2||||0.0033|TWO_SIDED|95.0|3.95|17.67|||Cochran-Mantel-Haenszel|||||17.67|3.95|0.0033
73892439|NCT02100696|147317768|SUPERIORITY||Treatment Difference|3.8||||0.4956|TWO_SIDED|95.0|-7.13|14.56|||Cochran-Mantel-Haenszel|||||14.56|-7.13|0.4956
73892440|NCT02100696|147317769|SUPERIORITY||Adjusted Difference in Remission Rates|12.5||||0.0028|TWO_SIDED|95.0|4.19|17.94||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||17.94|4.19|0.0028
73892441|NCT02100696|147317770|SUPERIORITY||Adjusted Difference in Response Rates|14.3||||0.0241|TWO_SIDED|95.0|3.21|24.14||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||24.14|3.21|0.0241
73892442|NCT02100696|147317771|SUPERIORITY||Adjusted Difference in Response Rates|8.1||||0.1605|TWO_SIDED|95.0|-2.54|17.22||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||17.22|-2.54|0.1605
73892443|NCT02100696|147317772|SUPERIORITY||Adjusted Difference in Remission Rates|7.6||||0.3881|TWO_SIDED|95.0|-1.22|13.66||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||13.66|-1.22|0.3881
73797299|NCT04856917|147140430|SUPERIORITY||Risk Difference (RD)|-0.12||||0.3741|TWO_SIDED|90.0|-0.33|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 20||0.09|-0.33|0.3741
73797300|NCT04856917|147140430|SUPERIORITY||Risk Difference (RD)|-0.13||||0.3321|TWO_SIDED|90.0|-0.33|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 20||0.09|-0.33|0.3321
73797301|NCT04856917|147140431|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.11||0.7932|TWO_SIDED|90.0|-1.56|2.14||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||2.14|-1.56|0.7932
73892444|NCT02100696|147317773|SUPERIORITY||Adjusted Difference in Remission Rates|4.9||||0.5879|TWO_SIDED|95.0|-6.78|14.69||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||14.69|-6.78|0.5879
73892445|NCT02100696|147317774|SUPERIORITY||Difference in Unadjusted Means|-0.2||||0.0351|TWO_SIDED|95.0|-0.5|0.0||Multiplicity P-value reported (adjusted for multiplicity)|ANCOVA|||||-0.0|-0.5|0.0351
73892446|NCT02100696|147317775|SUPERIORITY||Difference in Unadjusted Means|-0.2||||0.2698|TWO_SIDED|95.0|-0.4|0.1||Multiplicity P-value reported (adjusted for multiplicity)|ANCOVA|||||0.1|-0.4|0.2698
73892447|NCT02100696|147317776|SUPERIORITY||Difference in Least Square Means|-1.6||||0.2698|TWO_SIDED|95.0|-2.9|-0.3||Multiplicity P-value reported (adjusted for multiplicity)|Mixed Models Analysis|||||-0.3|-2.9|0.2698
73797302|NCT04856917|147140431|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.12||0.4365|TWO_SIDED|90.0|-0.99|2.73||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||2.73|-0.99|0.4365
73892448|NCT02100696|147317777|SUPERIORITY||Difference in Least Square Means|-0.5||||0.3881|TWO_SIDED|95.0|-1.0|0.0||Multiplicity P-value reported (adjusted for multiplicity)|Mixed Models Analysis|||||0.0|-1.0|0.3881
73797303|NCT04856917|147140431|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.8543|TWO_SIDED|90.0|-1.92|1.54||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||1.54|-1.92|0.8543
73797304|NCT04856917|147140431|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05||0.8726|TWO_SIDED|90.0|-1.91|1.58||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||1.58|-1.91|0.8726
73797305|NCT04856917|147140431|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.07||0.5983|TWO_SIDED|90.0|-1.22|2.35||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||2.35|-1.22|0.5983
73797306|NCT04856917|147140431|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.09||0.3396|TWO_SIDED|90.0|-0.77|2.86||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||2.86|-0.77|0.3396
73797307|NCT04856917|147140431|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.97||0.5305|TWO_SIDED|90.0|-2.23|1.01||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||1.01|-2.23|0.5305
73892449|NCT02100696|147317778|SUPERIORITY||Difference in Adjusted Means|9.1||||0.0445|TWO_SIDED|95.0|0.2|17.9||Nominal P-value reported (not adjusted for multiplicity)|ANCOVA|||||17.9|0.2|0.0445
73892450|NCT02100696|147317779|SUPERIORITY||Adjusted Difference in Remission Rates|0.1||||0.9959|TWO_SIDED|95.0|-19.67|19.88||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||19.88|-19.67|0.9959
73892451|NCT02100696|147317780|SUPERIORITY||Adjusted Difference in Remission Rates|3.8||||0.5014|TWO_SIDED|95.0|-7.26|14.7||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||14.70|-7.26|0.5014
73892452|NCT02100696|147317781|SUPERIORITY||Adjusted Difference in Remission Rates|0.6||||0.9538|TWO_SIDED|95.0|-19.08|20.35||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||20.35|-19.08|0.9538
73892453|NCT02100696|147317782|SUPERIORITY||Adjusted Difference in Response Rates|14.5||||0.0153|TWO_SIDED|95.0|2.66|25.78||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||25.78|2.66|0.0153
73892454|NCT02100696|147317783|SUPERIORITY||Adjusted Difference in Remission Rates|16.8||||0.0073|TWO_SIDED|95.0|4.44|28.41||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||28.41|4.44|0.0073
73892455|NCT02100696|147317784|SUPERIORITY||Adjusted Difference in Remission Rates|11.9||||0.0174|TWO_SIDED|95.0|1.87|21.71||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.71|1.87|0.0174
73797308|NCT04856917|147140431|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.96||0.0819|TWO_SIDED|90.0|0.09|3.29||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||3.29|0.09|0.0819
73892456|NCT02100696|147317785|SUPERIORITY||Adjusted Difference in Remission Rates|7.3||||0.3015|TWO_SIDED|95.0|-6.83|21.6||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.60|-6.83|0.3015
73892457|NCT02100696|147317786|SUPERIORITY||Adjusted Difference in Remission Rates|7.4||||0.2787|TWO_SIDED|95.0|-6.23|21.17||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.17|-6.23|0.2787
73892458|NCT02100696|147317787|SUPERIORITY||Difference in Least Square Means|-1.5||||0.0763|TWO_SIDED|95.0|-3.1|0.2||Nominal P-value reported (not adjusted for multiplicity)|Mixed Models Analysis|||||0.2|-3.1|0.0763
73892459|NCT02100696|147317788|SUPERIORITY||Difference in Least Square Means|-0.2||||0.5329|TWO_SIDED|95.0|-1.0|0.5||Nominal P-value reported (not adjusted for multiplicity)|Mixed Models Analysis|||||0.5|-1.0|0.5329
73892460|NCT02100696|147317789|SUPERIORITY||Difference in Adjusted Means|-4.9||||0.2228|TWO_SIDED|95.0|-12.7|3.0||Nominal P-value reported (not adjusted for multiplicity)|ANCOVA|||||3.0|-12.7|0.2228
73892461|NCT00078897|147317801|OTHER|Negative binomial regression|Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.91|1.16|||Negative binomial regression|||||1.16|0.91|0.68
73892462|NCT00233064|147317878|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.0||||||95.0|0.0|1.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||1.9|0.0|
73892463|NCT00233064|147317878|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.5||||||95.0|0.0|2.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||2.9|0.0|
73892464|NCT00233064|147317878|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.3||||||95.0|0.0|1.5|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||1.5|0.0|
73892465|NCT03508908|147317883|OTHER||US dollars per DALY averted|3098.0|||||TWO_SIDED||||||||Cost (in US dollars) per DALY averted (Intervention referenced to Observation)|Cost (in US dollars) per DALY averted (Intervention referenced to Observation)||||
73892466|NCT01120964|147317902|OTHER|Analyses presented herein are for re-intubation time included.|Mean Difference (Final Values)|32.0||||0.0222|TWO_SIDED|95.0|-9.5|73.4||The threshold for statistical significance was p\<0.05|Wilcoxon (Mann-Whitney)|||"Total duration of postoperative invasive mechanical ventilation was analyzed by treatment group using summary statistics, and was compared between citrulline and placebo groups using an ANOVA.~Kaplan-Meier analyses were performed for: 1) zero durations censored, 2) zero durations uncensored, 3) patients with zero duration excluded. The same analyses were performed with re-intubation time removed."||73.4|-9.5|0.0222
73892467|NCT01120964|147317903|OTHER||Mean Difference (Final Values)|32.0||||0.0222|TWO_SIDED|95.0|-9.5|73.4||Re-intubation time included. Threshold for significance was p\<0.05|t-test, 2 sided|||Analyses presented herein are for re-intubation time included.||73.4|-9.5|0.0222
73892468|NCT01120964|147317904|OTHER||Mean Difference (Final Values)|50.7||||0.0418|TWO_SIDED|95.0|5.4|96.0||The threshold for significance was P\<0.05|Wilcoxon (Mann-Whitney)|||||96.0|5.4|0.0418
73892469|NCT01120964|147317905|OTHER||Mean Difference (Final Values)|12.7||||0.0727|TWO_SIDED|95.0|-2.6|28.1||The threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||28.1|-2.6|0.0727
73892470|NCT01120964|147317906|OTHER||Mean Difference (Final Values)|559.8||||0.1271|TWO_SIDED|95.0|-193.5|1313.2|||Wilcoxon (Mann-Whitney)|||||1313.2|-193.5|0.1271
73892471|NCT01120964|147317907|OTHER||Mean Difference (Final Values)|3.5||||0.972|TWO_SIDED|95.0|-7.0|14.1|||Wilcoxon (Mann-Whitney)|||||14.1|-7.0|0.9720
73892472|NCT01120964|147317908|OTHER||Mean Difference (Final Values)|5.2||||0.8884|TWO_SIDED|95.0|-7.7|18.0|||Wilcoxon (Mann-Whitney)|||||18.0|-7.7|0.8884
73892473|NCT01120964|147317909|OTHER|Total number of postoperative hours spent in PICU|Mean Difference (Final Values)|69.14||||0.1891|TWO_SIDED|95.0|-49.39|187.67||The threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||187.67|-49.39|0.1891
73892474|NCT01120964|147317910|OTHER||Mean Difference (Final Values)|30.2||||0.0479|TWO_SIDED|95.0|-10.8|71.1||Duration including re-intubation time. Threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||71.1|-10.8|0.0479
73892475|NCT01120964|147317911|OTHER||Mean Difference (Final Values)|3.7||||0.2637|TWO_SIDED|95.0|-2.2|9.7|||Wilcoxon (Mann-Whitney)|||||9.7|-2.2|0.2637
73892476|NCT01120964|147317913|OTHER||Mean Difference (Final Values)|7.5||||0.6431|TWO_SIDED|95.0|-25.9|41.0|||t-test, 2 sided|||||41.0|-25.9|0.6431
73892477|NCT01120964|147317914|OTHER||Mean Difference (Final Values)|39.5||||0.6408|TWO_SIDED|95.0|-134.2|213.1|||ANOVA|||||213.1|-134.2|0.6408
73892478|NCT00826202|147317926|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|cohen's d= 0.67||||||0.07
73892479|NCT00826202|147317927|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED||||||t-test, 2 sided|cohen's d=0.84||||||.056
73892480|NCT00826202|147317928|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Mixed Models Analysis|Cohen's d=0.68||||||0.03
73892481|NCT00826202|147317929|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|cohen's d=0.93||||||0.12
73797309|NCT04856917|147140431|SUPERIORITY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.09||0.0243|TWO_SIDED|90.0|0.69|4.31||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||4.31|0.69|0.0243
73797310|NCT04856917|147140431|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.05||0.1061|TWO_SIDED|90.0|-0.03|3.46||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||3.46|-0.03|0.1061
73892482|NCT00829504|147317933|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.16||||||90.0|95.5|105.04|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105.04|95.5|
73892483|NCT00829504|147317934|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.76||||||90.0|95.45|108.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.49|95.45|
73892484|NCT00829504|147317935|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.1||||||90.0|95.64|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109|95.64|
73892485|NCT02260180|147317950|SUPERIORITY|2-tail alpha was set to 0.05 with no adjustment for multiple comparisons.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
73892486|NCT02260180|147317950|SUPERIORITY||||||<|0.0001|||||||Chi-squared|2-tail alpha was set to 0.05 with no adjustment for multiple comparisons.||||||<0.0001
73892487|NCT02260180|147317951|SUPERIORITY||||||<|0.0001||||||No adjustment for multiple comparisons were made.|ANCOVA|Baseline PLA was the covariate. Comparisons were performed within the model using least-squares means and the common error term.||||||<0.0001
73797311|NCT04856917|147140432|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.67||0.9333|TWO_SIDED|90.0|-2.69|2.97||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||2.97|-2.69|0.9333
73892488|NCT02260180|147317951|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons were conducted.|ANCOVA|Baseline PLA was the covariate. Comparisons were performed within the model using least-squares means and the common error term.||The primary efficacy analysis of mean change from baseline to Visit 8 PLA was performed using analysis of covariance (ANCOVA) with baseline PLA as the covariate. Comparisons between vehicle and each A-101 group were performed within the model using least-squares means and the common error term.||||<0.0001
73892489|NCT03860818|147317955|SUPERIORITY||||||<|0.001|||||||Chi-squared|||Rate of inpatient hospitalization during study||||<.001
73892490|NCT03860818|147317955|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
73892491|NCT03860818|147317956|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Statistical analysis applies to all rows.||||||<0.001
73892492|NCT03860818|147317957|SUPERIORITY|||||||0.9064|||||||Chi-squared|||||||0.9064
73892493|NCT03860818|147317958|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
73892494|NCT01396447|147317983|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.1292|TWO_SIDED|95.0|-4.3|0.5||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo|||0.5|-4.3|0.1292
73892495|NCT01396447|147317983|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.001|TWO_SIDED|95.0|-6.3|-1.6||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo|||-1.6|-6.3|0.0010
73892496|NCT01396447|147317983|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0374|TWO_SIDED|95.0|-4.9|-0.1||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo|||-0.1|-4.9|0.0374
73892497|NCT01396447|147317984|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.3025|TWO_SIDED|95.0|-0.4|0.1|||Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||0.1|-0.4|0.3025
73797312|NCT04856917|147140432|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.3972|TWO_SIDED|90.0|-1.4|4.27||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||4.27|-1.40|0.3972
73797313|NCT04856917|147140432|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.11||0.0662|TWO_SIDED|90.0|0.23|3.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||3.99|0.23|0.0662
73797314|NCT04856917|147140432|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.11||0.8898|TWO_SIDED|90.0|-1.73|2.04||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||2.04|-1.73|0.8898
73797315|NCT04856917|147140432|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.06||0.3664|TWO_SIDED|90.0|-0.85|2.82||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||2.82|-0.85|0.3664
73797316|NCT04856917|147140432|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.1||0.0655|TWO_SIDED|90.0|0.25|4.05||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||4.05|0.25|0.0655
73797317|NCT04856917|147140432|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.2||0.6921|TWO_SIDED|90.0|-1.61|2.57||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||2.57|-1.61|0.6921
73797318|NCT04856917|147140432|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.23||0.0406|TWO_SIDED|90.0|0.59|4.88||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||4.88|0.59|0.0406
73797319|NCT04856917|147140432|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.04||0.6872|TWO_SIDED|90.0|-2.24|1.38||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||1.38|-2.24|0.6872
73797320|NCT04856917|147140432|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.08||0.3392|TWO_SIDED|90.0|-0.81|2.92||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||2.92|-0.81|0.3392
73797321|NCT01169337|147140435|SUPERIORITY|||||||0.0005|||||||Log Rank|stratified 1-sided log-rank test||||||0.0005
73892498|NCT01396447|147317984|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0044|TWO_SIDED|95.0|-0.6|-0.2|||Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||-0.2|-0.6|0.0044
73797322|NCT03355469|147140466|SUPERIORITY||Mean Difference (Final Values)|3.53||||0.045|TWO_SIDED|95.0|0.08|6.99||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|Linear ANCOVA model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||6.99|0.08|0.045
73797323|NCT03355469|147140466|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.507|TWO_SIDED|95.0|-2.42|4.73||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||4.73|-2.42|0.507
73797324|NCT03355469|147140466|SUPERIORITY||Mean Difference (Final Values)|4.98||||0.014|TWO_SIDED|95.0|1.14|8.83||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.83|1.14|0.014
73797325|NCT03355469|147140466|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.237|TWO_SIDED|95.0|-1.66|6.42||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||6.42|-1.66|0.237
73797326|NCT03355469|147140466|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.486|TWO_SIDED|95.0|-2.8|5.7||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||5.70|-2.80|0.486
73797327|NCT03355469|147140466|SUPERIORITY||Mean Difference (Final Values)|3.83||||0.081|TWO_SIDED|95.0|-0.53|8.19||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.19|-0.53|0.081
73797328|NCT03355469|147140467|SUPERIORITY||Mean Difference (Final Values)|0.0073||||0.373|TWO_SIDED|95.0|-0.0093|0.024||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0240|-0.0093|0.373
73797329|NCT03355469|147140467|SUPERIORITY||Mean Difference (Final Values)|0.0097||||0.198|TWO_SIDED|95.0|-0.0055|0.025||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0250|-0.0055|0.198
73797330|NCT03355469|147140467|SUPERIORITY||Mean Difference (Final Values)|0.0041||||0.622|TWO_SIDED|95.0|-0.0129|0.0211||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0211|-0.0129|0.622
73797331|NCT03355469|147140467|SUPERIORITY||Mean Difference (Final Values)|-0.0024||||0.666|TWO_SIDED|95.0|-0.0136|0.0088||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0088|-0.0136|0.666
73797332|NCT03355469|147140467|SUPERIORITY||Mean Difference (Final Values)|-0.0032||||0.634|TWO_SIDED|95.0|-0.0169|0.0104||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0104|-0.0169|0.634
73797333|NCT03355469|147140467|SUPERIORITY||Mean Difference (Final Values)|-0.0056||||0.336|TWO_SIDED|95.0|-0.0174|0.0062||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0062|-0.0174|0.336
73797334|NCT03355469|147140468|SUPERIORITY||Mean Difference (Final Values)|1.51||||0.671|TWO_SIDED|95.0|-5.68|8.69||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.69|-5.68|0.671
73797335|NCT03355469|147140468|SUPERIORITY||Mean Difference (Final Values)|-4.82||||0.17|TWO_SIDED|95.0|-11.84|2.19||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||2.19|-11.84|0.170
73892499|NCT01396447|147317984|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0489|TWO_SIDED|95.0|-0.5|0.0|||Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||-0.0|-0.5|0.0489
73797336|NCT03355469|147140468|SUPERIORITY||Mean Difference (Final Values)|-0.66||||0.839|TWO_SIDED|95.0|-7.29|5.97||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||5.97|-7.29|0.839
73797337|NCT03355469|147140468|SUPERIORITY||Mean Difference (Final Values)|6.33||||0.024|TWO_SIDED|95.0|0.86|11.8||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||11.80|0.86|0.024
73797338|NCT03355469|147140468|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.385|TWO_SIDED|95.0|-7.16|2.83||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||2.83|-7.16|0.385
73797339|NCT03355469|147140468|SUPERIORITY||Mean Difference (Final Values)|4.17||||0.08|TWO_SIDED|95.0|-0.53|8.86||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.86|-0.53|0.080
73797340|NCT03355469|147140469|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.088|TWO_SIDED|95.0|-0.069|0.005||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.005|-0.069|0.088
73797341|NCT03355469|147140469|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.96|TWO_SIDED|95.0|-0.059|0.062||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.062|-0.059|0.960
73797342|NCT03355469|147140469|SUPERIORITY||Mean Difference (Final Values)|-0.052||||0.075|TWO_SIDED|95.0|-0.109|0.006||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.006|-0.109|0.075
73797343|NCT03355469|147140469|SUPERIORITY||Mean Difference (Final Values)|-0.033||||0.258|TWO_SIDED|95.0|-0.094|0.028||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.028|-0.094|0.258
73797344|NCT03355469|147140469|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.443|TWO_SIDED|95.0|-0.075|0.035||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.035|-0.075|0.443
73797345|NCT03355469|147140469|SUPERIORITY||Mean Difference (Final Values)|-0.053||||0.144|TWO_SIDED|95.0|-0.126|0.02||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.020|-0.126|0.144
73797346|NCT03355469|147140470|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.147|TWO_SIDED|95.0|-0.017|0.003||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.003|-0.017|0.147
73797347|NCT03355469|147140470|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.943|TWO_SIDED|95.0|-0.016|0.017||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.017|-0.016|0.943
73797348|NCT03355469|147140470|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.108|TWO_SIDED|95.0|-0.027|0.003||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.003|-0.027|0.108
73797349|NCT03355469|147140470|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.319|TWO_SIDED|95.0|-0.024|0.009||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.009|-0.024|0.319
73797350|NCT03355469|147140470|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.496|TWO_SIDED|95.0|-0.019|0.01||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.010|-0.019|0.496
73797351|NCT03355469|147140470|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.187|TWO_SIDED|95.0|-0.031|0.007||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.007|-0.031|0.187
73797352|NCT03355469|147140471|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.086|TWO_SIDED|95.0|-0.495|0.035||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.035|-0.495|0.086
73797353|NCT03355469|147140471|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.608|TWO_SIDED|95.0|-0.354|0.574||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.574|-0.354|0.608
73797354|NCT03355469|147140471|SUPERIORITY||Mean Difference (Final Values)|-0.344||||0.11|TWO_SIDED|95.0|-0.779|0.09||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.090|-0.779|0.110
73797355|NCT03355469|147140471|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.145|TWO_SIDED|95.0|-0.818|0.137||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.137|-0.818|0.145
73797356|NCT03355469|147140471|SUPERIORITY||Mean Difference (Final Values)|-0.114||||0.565|TWO_SIDED|95.0|-0.538|0.309||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.309|-0.538|0.565
73797357|NCT03355469|147140471|SUPERIORITY||Mean Difference (Final Values)|-0.454||||0.11|TWO_SIDED|95.0|-1.025|0.116||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.116|-1.025|0.110
73797358|NCT01708941|147140472|SUPERIORITY|||||||0.49|||||||Log Rank|||The primary comparison was ipilimumab + HDI versus ipilimumab alone, across ipilimumab dose (Arms A \& C versus Arms B \& D)||||0.490
73797359|NCT01708941|147140473|SUPERIORITY|||||||0.144|||||||Log Rank|||PFS comparison of higher dose ipilimumab versus lower dose ipilimumab (Arms A \& B versus Arms C \& D)||||0.144
73797360|NCT01708941|147140474|SUPERIORITY|||||||0.691|||||||Log Rank|||||||0.691
73797361|NCT01708941|147140475|SUPERIORITY|||||||0.868|||||||Log Rank|||Comparison of higher dose ipilimumab versus lower dose ipilimumab across HDI status (Arms A \& B versus Arms C \& D)||||0.868
73797362|NCT01575548|147140478|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.21|TWO_SIDED|95.0|0.54|1.29|||Log Rank|Stratified log rank test was used to compare DFS between the two arms.||||1.29|0.54|0.21
73797363|NCT02048813|147140493|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.22|0.56|||Log Rank|||||0.56|0.22|<.001
73797364|NCT02048813|147140494|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.05|0.54|||Log Rank|||||0.54|0.05|<.001
73797365|NCT01708954|147140505|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||||TWO_SIDED|80.0|0.25|0.53|||||Hazard ratio of Arm C/Arm A|||0.53|0.25|
73797366|NCT01708954|147140505|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|80.0|0.27|0.55|||||Hazard ratio of Arm B/Arm A|||0.55|0.27|
73797367|NCT01565356|147140516|SUPERIORITY_OR_OTHER||Kappa statistic|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||Cohen's (simple) kappa statistic||1.00|1.00|
73797368|NCT05534061|147140518|SUPERIORITY||Odds Ratio (OR)|0.98||||0.944|TWO_SIDED|95.0|0.62|1.56||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||1.56|0.62|.944
73797369|NCT05534061|147140519|SUPERIORITY||Odds Ratio (OR)|1.01||||0.952|TWO_SIDED|95.0|0.62|1.65||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||1.65|0.62|.952
73797370|NCT05534061|147140520|SUPERIORITY||Odds Ratio (OR)|1.16||||0.768|TWO_SIDED|95.0|0.43|3.11||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||3.11|0.43|.768
73797371|NCT05534061|147140521|SUPERIORITY||Odds Ratio (OR)|3.96||||0.008|TWO_SIDED|95.0|1.43|10.94||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||10.94|1.43|.008
73797372|NCT04138823|147140574|OTHER||Probability of DLT rate in [0.16,0.33)|0.172|||||||||||Bayesian logistic regression model|||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
73797373|NCT04138823|147140574|OTHER||Probability of DLT rate in [0.33, 1.00]|0.01||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
73797374|NCT04138823|147140574|OTHER||Probabilty of DLT rate in [0.16, 0.33)|0.362||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
73797375|NCT04138823|147140574|OTHER||Probability of DLT rate in [0.33, 1.00]|0.046||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
73797376|NCT04138823|147140574|OTHER||Probability of DLT rate in [0.16, 0.33)|0.478||||||||||||||"Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.~The 200 mg BI 891065 BID dose was modelled as equivalent to a 300 mg QD dose in terms of dose-toxicity relationship."||||
73797377|NCT04138823|147140574|OTHER||Probability of DLT rate in [0.33, 1.00]|0.118||||||||||||||"Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.~The 200 mg BI 891065 BID dose was modelled as equivalent to a 300 mg QD dose in terms of dose-toxicity relationship."||||
73797378|NCT02391987|147140596|SUPERIORITY|||||||0.73|||||||Cochran-Mantel-Haenszel|||||||0.73
73797379|NCT02391987|147140597|SUPERIORITY|||||||0.98|||||||Cochran-Mantel-Haenszel|||||||0.98
73797380|NCT02391987|147140598|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
73797381|NCT02213289|147140678|SUPERIORITY|||||||0.0024|||||||One-sided Z-test|This was a test of whether the observed 1-year survival rate was significantly different from historical 50% rate.||||||0.0024
73797382|NCT01579747|147140701|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Normality of distribution was assessed with the Shapiro-Wilk test. For normally-distributed continuous variables, the groups' distributions were described as means and standard deviations (SD). Student's t-test was used to compare groups in these cases with statistically-significant differences summarized using 95% confidence intervals as appropriate. For all comparisons, two-tailed p\<0.05 was considered statistically significant.||||<0.05
73797383|NCT06360081|147140711|EQUIVALENCE|The assessment of bioequivalence was based on two-sided 90% CIs for the ratios of the geometric means (gMean) (T/R) using an acceptance range of 80.0 to 125.0%.|Ratio of adjusted geometric means (T/R)|99.89|||<|0.0001|TWO_SIDED|90.0|97.08|102.78||p-value was calculated for ratios outside the 80.0 to 125.0% interval.|ANOVA||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 9.0%.|PK endpoints were back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. The model included effects accounting for variation in sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the others were considered as fixed. Confidence intervals were calculated based on the residual error from the ANOVA.||102.78|97.08|<0.0001
73797384|NCT06360081|147140712|EQUIVALENCE|The assessment of bioequivalence was based on two-sided 90% CIs for the ratios of the geometric means (gMean) (T/R) using an acceptance range of 80.0 to 125.0%.|Ratio of adjusted geometric means (T/R)|100.83|||<|0.0001|TWO_SIDED|90.0|96.43|105.44||p-value was calculated for ratios outside the 80.0 to 125.0% interval.|ANOVA||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 14.2%.|PK endpoints were back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. The model included effects accounting for variation in sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the others were considered as fixed. Confidence intervals were calculated based on the residual error from the ANOVA.||105.44|96.43|<0.0001
73797385|NCT02454608|147140750|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
73797386|NCT02454608|147140751|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
73797387|NCT02454608|147140752|SUPERIORITY_OR_OTHER|||||||0.25|||||||Mixed Models Analysis|||||||0.25
73797388|NCT02454608|147140753|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
73797389|NCT02454608|147140754|SUPERIORITY_OR_OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
73797390|NCT02454608|147140755|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
73797391|NCT02454608|147140756|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.7
73797392|NCT03573830|147140759|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.002|TWO_SIDED|95.0|0.04|0.2||Threshold for significance: \<0.05|t-test, 2 sided|||||0.20|0.04|0.002
73797393|NCT03573830|147140760|SUPERIORITY||Mean Difference (Final Values)|0.15||||0|TWO_SIDED|95.0|0.07|0.22||Threshold for significance: 0.05|t-test, 2 sided|||||0.22|0.07|0.000
73797394|NCT03573830|147140761|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.352|TWO_SIDED|95.0|-0.03|0.07||Threshold for significance: 0.05|t-test, 2 sided|||||0.07|-0.03|0.352
73797395|NCT03573830|147140762|SUPERIORITY||Mean Difference (Final Values)|0.45||||0|TWO_SIDED|95.0|0.34|0.56||Threshold for significance: \<0.05|t-test, 2 sided|||||0.56|0.34|0.000
73797396|NCT03573830|147140763|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.002|TWO_SIDED|95.0|0.05|0.22||Threshold for significance: 0.05|t-test, 2 sided|||||0.22|0.05|0.002
73797397|NCT03573830|147140764|SUPERIORITY||Mean Difference (Final Values)|32.56||||0.033|TWO_SIDED|95.0|2.65|62.46||Threshold for significance: \<0.05|t-test, 2 sided|||||62.46|2.65|0.033
73797398|NCT03573830|147140766|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.065|TWO_SIDED|95.0|0.0|0.19||Threshold for significance: \<0.05|t-test, 2 sided|||||0.19|0.00|0.065
73797399|NCT03573830|147140767|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.03|TWO_SIDED|95.0|0.01|0.28||Threshold for significance: \<0.05|t-test, 2 sided|||||0.28|0.01|0.030
73797400|NCT01769456|147140769|OTHER||||||<|0.0001||||||Reported p-value is the calculated value provided by SAS output.|Wilcoxon Signed Rank Test|||||||< 0.0001
73797401|NCT01769456|147140770|OTHER|||||||0.0236|||||||Wilcoxon Signed Rank Test|||||||0.0236
73797402|NCT01769456|147140771|OTHER|||||||0.0003|||||||Wilcoxon Signed Rank Test|||||||0.0003
73797403|NCT01769456|147140772|OTHER|||||||0.0236|||||||Wilcoxon Signed Rank Test|||||||0.0236
73797404|NCT02969382|147140815|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.23||0.001|TWO_SIDED|95.0|-11.9|-3.0|||Mixed Models Analysis|||||-3.0|-11.9|0.001
73797405|NCT02969382|147140816|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||||-0.2|-0.7|<0.001
73797406|NCT02969382|147140817|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.71||0.019|TWO_SIDED|95.0|-3.1|-0.3|||Mixed Models Analysis|||||-0.3|-3.1|0.019
73797407|NCT02969382|147140818|SUPERIORITY||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.55||0.008|TWO_SIDED|95.0|-2.6|-0.4|||Mixed Models Analysis|||||-0.4|-2.6|0.008
73797408|NCT02969382|147140819|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|-6.6|-2.0|||Mixed Models Analysis|||||-2.0|-6.6|<0.001
73797409|NCT02969382|147140820|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|1.26|<|0.001|TWO_SIDED|95.0|-6.8|-1.8|||Mixed Models Analysis|||||-1.8|-6.8|<0.001
73797410|NCT02969382|147140821|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.02|TWO_SIDED|95.0|-3.2|-0.3|||Mixed Models Analysis|||||-0.3|-3.2|0.020
73797411|NCT02969382|147140822|SUPERIORITY||Odds Ratio (OR)|2.645||||0.002|TWO_SIDED|95.0|1.422|4.921|||Regression, Logistic|||||4.921|1.422|0.002
73797412|NCT02969382|147140824|OTHER|||||||0.498|||||||Fisher Exact|||||||0.498
73797413|NCT02969382|147140825|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
73797414|NCT02969382|147140826|OTHER|||||||0.498|||||||Fisher Exact|||||||0.498
73797415|NCT02422797|147140966|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -10%.|Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-3.9|4.2|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INSTI).|||4.2|-3.9|
73797416|NCT02422797|147140968|OTHER||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-4.0|1.8|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INSTI). No formal non-inferiority margin has been pre-specified for secondary endpoints.|||1.8|-4.0|
73797417|NCT02422797|147140979|OTHER|||||||0.007||||||P-value for interaction between treatment group and Baseline third agent (25 hydroxy-vitamin D)|ANCOVA|||||||0.007
73797418|NCT02422797|147140979|SUPERIORITY||Odds Ratio (OR)|0.861||||0.011|TWO_SIDED|95.0|0.767|0.967||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.967|0.767|0.011
73797419|NCT02422797|147140979|SUPERIORITY||Odds Ratio (OR)|1.012||||0.745|TWO_SIDED|95.0|0.943|1.085||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||1.085|0.943|0.745
73797420|NCT02422797|147140979|SUPERIORITY||Odds Ratio (OR)|0.877||||0.018|TWO_SIDED|95.0|0.787|0.977||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.977|0.787|0.018
73797421|NCT02422797|147140981|OTHER|||||||0.001||||||P-value for interaction between treatment group and Baseline third agent (bone-specific alkaline phosphatase)|ANCOVA|||||||0.001
73797422|NCT02422797|147140981|SUPERIORITY||Odds Ratio (OR)|0.728|||<|0.001|TWO_SIDED|95.0|0.686|0.773||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.773|0.686|<.001
73797423|NCT02422797|147140981|SUPERIORITY||Odds Ratio (OR)|0.865||||0.004|TWO_SIDED|95.0|0.785|0.954||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.954|0.785|0.004
73797424|NCT02422797|147140981|SUPERIORITY||Odds Ratio (OR)|0.788|||<|0.001|TWO_SIDED|95.0|0.719|0.864||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.864|0.719|<.001
73797425|NCT02422797|147140981|OTHER|||||||0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA|||||||0.677
73797426|NCT02422797|147140981|SUPERIORITY||Odds Ratio (OR)|0.867|||<|0.001|TWO_SIDED|95.0|0.823|0.914||P value assessed the difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.914|0.823|<.001
73797427|NCT02422797|147140981|OTHER||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA|||||||<.001
73797428|NCT02422797|147140981|SUPERIORITY||Odds Ratio (OR)|0.853|||<|0.001|TWO_SIDED|95.0|0.799|0.91||P value assessed the difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.910|0.799|<.001
73797429|NCT02422797|147140981|SUPERIORITY||Odds Ratio (OR)|0.886||||0.028|TWO_SIDED|95.0|0.796|0.987||P value assessed the difference between treatment groups (osteocalcin - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.987|0.796|0.028
73797430|NCT02422797|147140981|SUPERIORITY||Odds Ratio (OR)|0.743|||<|0.001|TWO_SIDED|95.0|0.672|0.822||P value assessed the difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.822|0.672|<.001
73797431|NCT02422797|147140981|OTHER|||||||0.782||||||P-value for interaction between treatment group and Baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA|||||||0.782
73797432|NCT02422797|147140981|SUPERIORITY||Odds Ratio (OR)|0.818|||<|0.001|TWO_SIDED|95.0|0.751|0.891||P value assessed the difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.891|0.751|<.001
73797433|NCT02422797|147140994|OTHER|||||||0.179||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value \<=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected|||||||0.179
73797434|NCT02422797|147140994|OTHER||Risk Difference (RD)|3.5|||||TWO_SIDED|95.0|-1.6|8.6|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||8.6|-1.6|
73797435|NCT02422797|147140994|OTHER||Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-12.1|7.4|||||INSTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||7.4|-12.1|
73797436|NCT02422797|147140994|OTHER||Risk Difference (RD)|-5.4|||||TWO_SIDED|95.0|-13.9|3.1|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||3.1|-13.9|
73797437|NCT02422797|147141002|OTHER|||||||0.43||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA|||||||0.430
73797438|NCT02422797|147141002|OTHER||Mean Difference (Final Values)|-1.239||||0.039|TWO_SIDED|95.0|-2.414|-0.064||P value assessed the difference between treatment groups (Symptom Bother Score - Week 4)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-0.064|-2.414|0.039
73797439|NCT02422797|147141002|OTHER|||||||0.542||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA|||||||0.542
73797440|NCT02422797|147141002|SUPERIORITY||Mean Difference (Final Values)|-0.528||||0.448|TWO_SIDED|95.0|-1.896|0.84||P value assessed the difference between treatment groups (Symptom Bother Score - Week 24)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.840|-1.896|0.448
73797441|NCT02422797|147141002|OTHER|||||||0.402||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA|||||||0.402
73797442|NCT02422797|147141002|SUPERIORITY||Mean Difference (Final Values)|-1.037||||0.164|TWO_SIDED|95.0|-2.501|0.426||P value assessed the difference between treatment groups (Symptom Bother Score - Week 48)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.426|-2.501|0.164
73797443|NCT02422797|147141005|SUPERIORITY|||||||0.037||||||P-value assessed the HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.037
73797444|NCT02422797|147141005|SUPERIORITY|||||||0.101||||||P-value assessed the HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.101
73797445|NCT02422797|147141005|SUPERIORITY|||||||0.042||||||P-value assessed the HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.042
73797446|NCT02422797|147141005|SUPERIORITY|||||||0.132||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.132
73797447|NCT02422797|147141005|SUPERIORITY|||||||0.022||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.022
73797448|NCT02422797|147141005|SUPERIORITY|||||||0.004||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.004
73797449|NCT02422797|147141005|SUPERIORITY|||||||0.076||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.076
73797450|NCT02422797|147141005|SUPERIORITY|||||||0.073||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.073
73797451|NCT02422797|147141005|SUPERIORITY|||||||0.547||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.547
73797452|NCT00403585|147141120|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 156.|Wilcoxon signed rank|||||||<0.001
73892500|NCT04881942|147317987|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|89.44||||0.0184|TWO_SIDED|95.0|15.77|163.11|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham)|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||163.11|15.77|0.0184
73892501|NCT04881942|147317987|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|195.7|||<|0.0001|TWO_SIDED|95.0|122.01|269.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||269.38|122.01|<.0001
73892502|NCT04881942|147317987|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|168.83|||<|0.0001|TWO_SIDED|95.0|95.17|242.5|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||242.50|95.17|<.0001
73892503|NCT04881942|147317987|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|182.65|||<|0.0001|TWO_SIDED|95.0|108.63|256.67|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||256.67|108.63|<.0001
73892504|NCT04881942|147317990|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|5972.3|||<|0.0001|TWO_SIDED|95.0|4191.1|7753.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7753.6|4191.1|<.0001
73892505|NCT04881942|147317990|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|6099.5|||<|0.0001|TWO_SIDED|95.0|4317.8|7881.2|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7881.2|4317.8|<.0001
73892506|NCT04881942|147317990|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|6484.7|||<|0.0001|TWO_SIDED|95.0|4701.7|8267.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||8267.6|4701.7|<.0001
73797453|NCT02276807|147141126|SUPERIORITY||Mean Difference (Final Values)|0.345|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline vs. Week 12) repeated measures ANOVA||||||<0.05
73797454|NCT02276807|147141127|SUPERIORITY||Mean Difference (Final Values)|0.046|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (time: Baseline vs. week 12) repeated measures ANOVA||||||<0.05
73797455|NCT02276807|147141128|SUPERIORITY||Mean Difference (Final Values)|0.666|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA||||||<0.05
73797456|NCT02276807|147141129|SUPERIORITY||Mean Difference (Final Values)|0.014|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA||||||<0.05
73797457|NCT02276807|147141130|SUPERIORITY||Mean Difference (Final Values)|0.722|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline vs. Week 12) Repeated Measures ANOVA||||||<0.05
73797458|NCT03971474|147141131|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.05|TWO_SIDED|80.0|0.51|0.92||If either P value from the two tests (standard stratified log-rank and weighted log-rank) was \< 0.0972, the study would be considered to have rejected the null at the one-sided 10% level.|Log Rank|Testing was performed using a standard stratified log-rank test.|Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model including the stratification factors (PD-L1 status and histology) and 80% CIs.|Comparison of OS was performed using a standard stratified log-rank test and a weighted log-rank test. The study had 90% power to detect the scenario with overlapping curves up to 3 months and a hazard ratio of 0.5 after 3 months, assuming exponentially distributed survival times, a median OS of 10.5 months in the SOC arm, and uniform accrual over 21-24 months. This analysis reports the standard stratified log-rank test.||0.92|0.51|0.05
73797459|NCT03971474|147141131|SUPERIORITY|||||||0.15||||||If either p-value from the two tests (standard stratified log-rank and weighted log-rank) was \< 0.0972, the study would be considered to have rejected the null at the one-sided 10% level.|Log Rank|||Comparison of OS was performed using a standard stratified log-rank test and a weighted log-rank test. The study had 90% power to detect the scenario with overlapping curves up to 3 months and a hazard ratio of 0.5 after 3 months, assuming exponentially distributed survival times, a median OS of 10.5 months in the SOC arm, and uniform accrual over 21-24 months. This analysis reports the weighted log-rank test.||||0.15
73797460|NCT03971474|147141132|SUPERIORITY|||||||0.19||||||Proportions were compared using a chi-squared test at the one-sided 5% level.|Chi-squared|||||||0.19
73797461|NCT03971474|147141133|SUPERIORITY|||||||0.38||||||Proportions were compared using a chi-squared test at the one-sided 5% level.|Chi-squared|||||||0.38
73797462|NCT03971474|147141136|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.25|TWO_SIDED|80.0|0.66|1.14|||Log Rank|Testing was performed using a standard stratified log-rank test.|Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model including the stratification factors (PD-L1 status and histology) and 80% CIs.|Comparison of IA-PFS was performed using a standard stratified log-rank test and a weighted log-rank test with weights equal to 1-S(t), where S(t) is the pooled survival estimate at time t (G\[rho=0, gamma=1\]). The weighted test weights later events over earlier events and has more power than the standard log-rank test under a delayed separation in the curves. This analysis reports the standard stratified log-rank test.||1.14|0.66|0.25
73797463|NCT03971474|147141136|SUPERIORITY|||||||0.14|||||||Log Rank|Testing was performed using a weighted log-rank test.||Comparison of IA-PFS between the RP and SOC arms was performed using a standard stratified log-rank test and a weighted log-rank test with weights equal to 1-S(t), where S(t) is the pooled survival estimate at time t (G\[rho=0, gamma=1\]). The weighted test weights later events over earlier events and has more power than the standard log-rank test under a delayed separation in the curves. This analysis reports the weighted log-rank test.||||0.14
73797464|NCT03971474|147141137|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.16|TWO_SIDED|80.0|0.5|1.1||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \< 1% subgroup.||1.10|0.50|0.16
73797465|NCT03971474|147141137|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.08|TWO_SIDED|80.0|0.45|0.97||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \>= 1% subgroup.||0.97|0.45|0.08
73797466|NCT03971474|147141137|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.005|TWO_SIDED|80.0|0.28|0.65||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the squamous histology subgroup.||0.65|0.28|0.005
73797467|NCT03971474|147141137|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.43|TWO_SIDED|80.0|0.67|1.35||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the non-squamous histology subgroup.||1.35|0.67|0.43
73797468|NCT03971474|147141138|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.28|TWO_SIDED|80.0|0.58|1.22||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \< 1% subgroup.||1.22|0.58|0.28
73797469|NCT03971474|147141138|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.07|TWO_SIDED|80.0|0.48|0.95||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \>= 1% subgroup.||0.95|0.48|0.07
73797470|NCT03971474|147141138|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.02|TWO_SIDED|80.0|0.38|0.8||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the squamous histology subgroup.||0.80|0.38|0.02
73797471|NCT03971474|147141138|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.41|TWO_SIDED|80.0|0.69|1.29||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the non-squamous histology subgroup.||1.29|0.69|0.41
73797472|NCT01937871|147141157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.41|||||TWO_SIDED|95.0|-2.25|-0.57||||||||-0.57|-2.25|
73797473|NCT01937871|147141161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-1.87|0.18||||||||0.18|-1.87|
73797474|NCT01894087|147141239|SUPERIORITY||Incidence Rate Ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||||Numerator is Therapist-led Brief Intervention, Denominator is Enhanced Usual Care only.|Multivariable Poisson regression of outcome of overdose risk behavior sum score at 6 months, adjusting for baseline level of the outcome||0.87|0.59|
73797475|NCT01894087|147141240|SUPERIORITY||Slope|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Numerator is the Therapist-Led Brief Intervention and Denominator is Enhanced Usual Care only|Multivariable linear regression of the outcome of standardized sum score of overdose symptom knowledge at 6 months follow-up, adjusted for baseline level of overdose symptom knowledge.||0.40|-0.20|
73797476|NCT01894087|147141241|SUPERIORITY||Incidence Rate Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of using opioids as prescribed). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to use opioids as prescribed, adjusting for baseline level of the outcome.||1.33|0.93|
73797477|NCT01894087|147141241|SUPERIORITY||Incidence Rate Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.9|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of reducing or avoiding opioid use). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid or reduce opioid use, adjusting for baseline level of the outcome.||0.90|0.65|
73797478|NCT01894087|147141241|SUPERIORITY||Incidence Rate Ratio|0.97|||||TWO_SIDED|95.0|0.8|1.19|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of not combining opioids with other drugs). Numerator was Therapist-Led Brief Intervention and denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid combining opioids with other substances, adjusting for baseline level of the outcome.||1.19|0.80|
73797479|NCT01894087|147141242|SUPERIORITY||Incidence Rate Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.92|||||Numerator is Therapist-Led Brief Intervention, Denominator is Enhanced Usual Care only|Multivariable Poisson regression for the outcome of total COMM score at follow-up, adjusting for baseline level of the outcome||0.92|0.70|
73797480|NCT02466685|147141370|SUPERIORITY||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|9.4|<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
73797481|NCT02374346|147141374|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.23||||0.001|TWO_SIDED|95.0|2.04|5.13|||t-test, 2 sided|||Sevoflurane administration in developing postoperative headache||5.13|2.04|0.001
73797482|NCT02374346|147141374|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.006|TWO_SIDED|95.0|1.19|2.84|||t-test, 2 sided|||Smoking as a factor for developing postoperative headache||2.84|1.19|0.006
73797483|NCT02374346|147141374|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|2.11||||0.008|TWO_SIDED|95.0|1.22|3.66|||t-test, 2 sided|||Intraoperative hypotension associated with postoperative headache in total sample||3.66|1.22|0.008
73797484|NCT02374346|147141374|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.024|TWO_SIDED|95.0|1.08|3.15|||t-test, 2 sided|||Female gender as a factor for developing postoperative headache||3.15|1.08|0.024
73797485|NCT02374346|147141374|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.56||||0.005|TWO_SIDED|95.0|1.58|13.17|||t-test, 2 sided|||Association of female gender and postoperative headache||13.17|1.58|0.005
73797486|NCT02374346|147141374|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.79||||0.006|TWO_SIDED|95.0|1.48|9.72|||t-test, 2 sided|||Association of intraoperative hypotension and postoperative headache||9.72|1.48|0.006
73797487|NCT02374346|147141374|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.86||||0.041|TWO_SIDED|95.0|1.06|14.06|||t-test, 2 sided|||Association of caffeine consumption and postoperative headache||14.06|1.06|0.041
73797488|NCT02374346|147141374|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test.Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.26||||0.001|TWO_SIDED|95.0|1.82|9.95|||t-test, 2 sided|||Association of sevoflurane administration and postoperative headache||9.95|1.82|0.001
73797489|NCT00125515|147141433|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|95.0|||||Chi-squared|||all statistical analysis were two tailed and employed an alpha significance level of 0.05.||||0.32
73797490|NCT02359994|147141435|NON_INFERIORITY|Non-inferiority was assessed with a pre-specified non-inferiority margin of 10%, such that the endpoint is successfully met if the non-inferiority one-sided p-value is less than 0.025 or, equivalently, if the lower bound of a two-sided 95% confidence interval for the difference between PerClot and Arista hemostasis rates is greater than -10%.|Difference in percentage of participants|-1.4||||0.005|TWO_SIDED|95.0|-7.5|4.8|||Farrington-Manning score test||Directionality for difference in the percentage of participants achieving endpoint: PerClot - Arista|The primary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 7 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 7 minutes in the Arista group, the active control.||4.8|-7.5|0.005
73797491|NCT02359994|147141436|NON_INFERIORITY|Non-inferiority was assessed with a pre-specified non-inferiority margin of 10%, such that the endpoint is successfully met if the non-inferiority one-sided p-value is less than 0.025 or, equivalently, if the lower bound of a two-sided 95% confidence interval for the difference between PerClot and Arista hemostasis rates is greater than -10%.|Difference in Percentage of Participants|4.8|||<|0.001|TWO_SIDED|95.0|-2.4|12.0|||Farrington-Manning score test||Directionality for difference in the percentage of participants achieving endpoint: PerClot - Arista|The secondary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 5 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 5 minutes in the Arista group, the active control.||12.0|-2.4|<0.001
73797492|NCT00207883|147141437|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
73797493|NCT04182334|147141531|SUPERIORITY|||||||0.775|||||||Mixed Models Analysis|||||||0.775
73797494|NCT04182334|147141532|SUPERIORITY|||||||0.995|||||||Mixed Models Analysis|||||||0.995
73797495|NCT04182334|147141533|SUPERIORITY|||||||0.674|||||||Mixed Models Analysis|||||||0.674
73797496|NCT04182334|147141534|SUPERIORITY|||||||0.326|||||||Mixed Models Analysis|||||||0.326
73797497|NCT04182334|147141535|SUPERIORITY|||||||0.463|||||||Wilcoxon (Mann-Whitney)|||||||0.463
73797498|NCT04182334|147141536|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
73797499|NCT04182334|147141537|SUPERIORITY|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||||||0.505
73797500|NCT04182334|147141538|SUPERIORITY|||||||0.612|||||||Wilcoxon (Mann-Whitney)|||||||0.612
73797501|NCT04182334|147141539|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
73797502|NCT04182334|147141540|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
73797503|NCT04460885|147141555|NON_INFERIORITY|The response and change from baseline in response after 52 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and region as fixed factors, and baseline response as covariate.|Treatment difference|-0.19|||<|0.0001|TWO_SIDED|95.0|-0.36|-0.03|||ANCOVA|||||-0.03|-0.36|<0.0001
73797504|NCT00486525|147141707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075|STANDARD_ERROR_OF_MEAN|0.058||0.2|TWO_SIDED|95.0|-0.19|0.039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.039|-0.19|0.20
73797505|NCT00486525|147141707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.027|TWO_SIDED|95.0|-0.25|-0.015|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.015|-0.25|0.027
73797506|NCT00486525|147141707|SUPERIORITY_OR_OTHER||Slope|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.28|TWO_SIDED|95.0|-0.06|0.018|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.018|-0.060|0.28
73797507|NCT00486525|147141707|SUPERIORITY_OR_OTHER||Slope|-0.038|STANDARD_ERROR_OF_MEAN|0.02||0.063|TWO_SIDED|95.0|-0.079|0.0021|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.0021|-0.079|0.063
73797508|NCT00486525|147141708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.062||0.2|TWO_SIDED|95.0|-0.2|-0.042|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.042|-0.2|0.2
73797509|NCT00486525|147141708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.064||0.015|TWO_SIDED|95.0|-0.28|-0.031|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.031|-0.28|0.015
73797510|NCT00486525|147141708|SUPERIORITY_OR_OTHER||Slope|-0.022|STANDARD_ERROR_OF_MEAN|0.021||0.3|TWO_SIDED|95.0|-0.063|0.019|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.019|-0.063|0.3
73892507|NCT04881942|147317990|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|5366.8|||<|0.0001|TWO_SIDED|95.0|3575.9|7157.7|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7157.7|3575.9|<.0001
73892508|NCT04881942|147317993|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.17||||0.915|TWO_SIDED|95.0|-2.92|3.25|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3.25|-2.92|0.9150
73892509|NCT04881942|147317993|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.35||||0.8217|TWO_SIDED|95.0|-2.7|3.4|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3.40|-2.70|0.8217
73892510|NCT04881942|147317993|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|21.11|||<|0.0001|TWO_SIDED|95.0|18.06|24.16|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||24.16|18.06|<.0001
73797511|NCT00486525|147141708|SUPERIORITY_OR_OTHER||Slope|-0.056|STANDARD_ERROR_OF_MEAN|0.022||0.01|TWO_SIDED|95.0|-0.098|-0.013|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.013|-0.098|0.01
73797512|NCT00486525|147141709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.33|TWO_SIDED|95.0|-0.31|0.11|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.11|-0.31|0.33
73892511|NCT04881942|147317993|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|31.01|||<|0.0001|TWO_SIDED|95.0|27.91|34.12|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||34.12|27.91|<.0001
73797513|NCT00486525|147141709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.037|TWO_SIDED|95.0|-0.44|-0.014|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.014|-0.44|0.037
73797514|NCT00486525|147141709|SUPERIORITY_OR_OTHER||Slope|-0.034|STANDARD_ERROR_OF_MEAN|0.0235||0.33|TWO_SIDED|95.0|-0.1|0.035|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.035|-0.10|0.33
73797515|NCT00486525|147141709|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.036||0.03|TWO_SIDED|95.0|-0.15|-0.0074|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.0074|-0.15|0.03
73797516|NCT00486525|147141710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.2||0.058|TWO_SIDED|95.0|-8.5|0.15|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.15|-8.5|0.058
73797517|NCT00486525|147141710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|2.2||0.002|TWO_SIDED|95.0|-11.4|-2.7|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-2.7|-11.4|0.002
73797518|NCT00486525|147141710|SUPERIORITY_OR_OTHER||Slope|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.019|TWO_SIDED|95.0|-3.1|-0.28|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of MFSI-SF Fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.28|-3.1|0.019
73797519|NCT00486525|147141710|SUPERIORITY_OR_OTHER||Slope|-2.8|STANDARD_ERROR_OF_MEAN|0.71||0.0001|TWO_SIDED|95.0|-4.2|-1.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of MFSI-SF fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-1.4|-4.2|0.0001
73797520|NCT00486525|147141711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|2.5||0.01|TWO_SIDED|95.0|1.4|11.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||11.4|1.4|0.01
73797521|NCT00486525|147141711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.5||0.01|TWO_SIDED|95.0|1.5|11.6|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||11.6|1.5|0.01
73797522|NCT00486525|147141711|SUPERIORITY_OR_OTHER||Slope|2.1|STANDARD_ERROR_OF_MEAN|0.85||0.016|TWO_SIDED|95.0|0.4|3.75|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||3.75|0.40|0.016
73797523|NCT00486525|147141711|SUPERIORITY_OR_OTHER||Slope|2.5|STANDARD_ERROR_OF_MEAN|0.85||0.0045|TWO_SIDED|95.0|0.77|4.14|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||4.14|0.77|0.0045
73797524|NCT00486525|147141712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.98||0.28|TWO_SIDED|95.0|-3.0|0.88|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.88|-3.0|0.28
73797525|NCT00486525|147141712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.99||0.21|TWO_SIDED|95.0|-3.2|0.69|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.69|-3.2|0.21
73797526|NCT00486525|147141712|SUPERIORITY_OR_OTHER||Slope|-0.66|STANDARD_ERROR_OF_MEAN|0.34||0.051|TWO_SIDED|95.0|-1.3|0.0039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of CES-D for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.0039|-1.3|0.051
73797527|NCT00486525|147141712|SUPERIORITY_OR_OTHER||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.34||0.098|TWO_SIDED|95.0|-1.2|0.1|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of CESD for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.10|-1.2|0.098
73797528|NCT00886015|147141770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.96|1.93||||||||1.93|0.96|
73797529|NCT00886015|147141771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.46|0.98||||||||0.98|0.46|
73797530|NCT00886015|147141772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.66|1.18||||||||1.18|0.66|
73797531|NCT00886015|147141773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.44|0.98||||||||0.98|0.44|
73797532|NCT00886015|147141774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.42|0.97||||||Mild ECA compared with Normal||0.97|0.42|
73797533|NCT00886015|147141774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.39|1.01||||||Moderate ECA compared with Normal||1.01|0.39|
73797534|NCT00886015|147141774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.35|1.1||||||Severe ECA compared with Normal||1.10|0.35|
73797535|NCT00886015|147141775|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.97|1.53||||||||1.53|0.97|
73797536|NCT05490771|147141782|SUPERIORITY|||||||0.0341|||||||one-sided exact binomial test|||The ORR was compared against a null benchmark value of 5%. If the observed ORR were ≥5 of 31 (16%), it would then be concluded that the agent is promising and worthy of further investigation. When the number of analyzable cases (who were eligible and treated, and with outside assay results confirmed by the central MATCH assay) was \<31, the one-sided exact binomial test would be used for significance test with one-side type I error rate of 5%.||||0.0341
73797537|NCT02964312|147141790|SUPERIORITY||Proportion|89.5|||||TWO_SIDED|95.0|83.5|93.9||||||The null hypothesis was that the proportion of responders at 6 months would be 50%. Since there was not direct comparison group, the hypothesis was set as a superiority comparison to a target proportion (66%) with a power level \>90%.||93.9|83.5|
73797538|NCT02964312|147141793|SUPERIORITY||||||<|0.001||||||P values are based on paired t-tests for change from baseline with p\<0.05 indicating significance.|t-test, 2 sided|||||||<0.001
73797539|NCT03126435|147141841|SUPERIORITY|||||||0.6647|||||||Log Rank|P-Value is from a stratified log-rank test.||||||0.6647
73797540|NCT03126435|147141842|SUPERIORITY|||||||0.4345|||||||Log Rank|P-Value is from a stratified log-rank test.||||||0.4345
73797541|NCT03126435|147141843|SUPERIORITY|||||||0.2632|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records||||||0.2632
73797542|NCT03126435|147141845|SUPERIORITY|||||||0.1002|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records.||||||0.1002
73797543|NCT03126435|147141846|SUPERIORITY|||||||0.9882|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records.||||||0.9882
73797544|NCT01023035|147141850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-8.6|7.2|||Mantel-Haenszel, modified Koch method|||The modified Koch method was used to calculate the stratum-adjusted Mantel-Haenszel (MH) difference between the SVR rates for the Erythropoietin Use Arm versus the Ribavirin Dose Reduction Arm and corresponding 95% confidence interval with continuity correction.||7.2|-8.6|
73797545|NCT03127514|147141868|SUPERIORITY|||||||0.03||||||A two-tailed P value of 0.05 or less was considered to indicate statistical significance.|Mixed Models Analysis|Random-slope, shared-baseline, linear mixed model was adjusted for age and prebaseline ALSFRS-R slope||||||0.03
73797546|NCT02413229|147141877|SUPERIORITY|||||||0.3571|||||||Cochran-Mantel-Haenszel|||||||0.3571
73797547|NCT02413229|147141877|SUPERIORITY|||||||0.5224|||||||Cochran-Mantel-Haenszel|||||||0.5224
73797548|NCT02413229|147141877|SUPERIORITY|||||||0.389|||||||Cochran-Mantel-Haenszel|||||||0.3890
73797549|NCT02413229|147141877|SUPERIORITY|||||||0.0325|||||||Cochran-Mantel-Haenszel|||||||.0325
73797550|NCT03022370|147141886|SUPERIORITY||Odds Ratio (OR)|0.92|||=|0.686|TWO_SIDED|95.0|0.62|1.37|||Regression, Logistic|||||1.37|0.62|=0.686
73797551|NCT03022370|147141886|SUPERIORITY||Odds Ratio (OR)|0.71|||=|0.032|TWO_SIDED|95.0|0.51|0.97|||Regression, Logistic|||||0.97|0.51|=0.032
73797552|NCT03022370|147141887|SUPERIORITY||Odds Ratio (OR)|0.9||||0.555|TWO_SIDED|95.0|0.64|1.28|||Regression, Logistic|||||1.28|0.64|0.555
73797553|NCT03022370|147141887|SUPERIORITY||Odds Ratio (OR)|0.74||||0.072|TWO_SIDED|95.0|0.54|1.03|||Regression, Logistic|||||1.03|0.54|0.072
73797554|NCT03022370|147141888|SUPERIORITY||Odds Ratio (OR)|0.93||||0.672|TWO_SIDED|95.0|0.66|1.31|||Regression, Logistic|||||1.31|0.66|0.672
73797555|NCT03022370|147141888|SUPERIORITY||Odds Ratio (OR)|0.7||||0.019|TWO_SIDED|95.0|0.52|0.94|||Regression, Logistic|||||0.94|0.52|0.019
73797556|NCT03022370|147141889|SUPERIORITY||Slope|-0.01||||0.984|TWO_SIDED|95.0|-0.88|0.86|||Regression, Linear|||||0.86|-0.88|0.984
73797557|NCT03022370|147141889|SUPERIORITY||Slope|0.06||||0.839|TWO_SIDED|95.0|-0.51|0.63|||Regression, Linear|||||0.63|-0.51|0.839
73797558|NCT03022370|147141890|SUPERIORITY||Slope|0.97|||<|0.0001|TWO_SIDED|95.0|0.43|1.51|||Tobit|Log + 1 performed on data||||1.51|0.43|<0.0001
73797559|NCT03022370|147141890|SUPERIORITY||Slope|0.21||||0.521|TWO_SIDED|95.0|-0.42|0.83|||Tobit|Log plus 1 to transform data||||0.83|-0.42|0.521
73797560|NCT03022370|147141891|SUPERIORITY||Slope|0.25||||0.718|TWO_SIDED|95.0|-1.09|1.58|||Regression, Linear|||||1.58|-1.09|0.718
73797561|NCT03022370|147141891|SUPERIORITY||Slope|-0.3||||0.712|TWO_SIDED|95.0|-1.87|1.28|||Regression, Linear|||||1.28|-1.87|0.712
73797562|NCT03022370|147141892|SUPERIORITY||Slope|-1.52||||0.067|TWO_SIDED|95.0|-3.14|0.11|||Regression, Linear|||||0.11|-3.14|0.067
73797563|NCT03022370|147141892|SUPERIORITY||Slope|-0.75||||0.398|TWO_SIDED|95.0|-2.48|0.99|||Regression, Linear|||||0.99|-2.48|0.398
73797564|NCT03022370|147141893|SUPERIORITY||Odds Ratio (OR)|1.29||||0.228|TWO_SIDED|95.0|0.85|1.97|||Regression, Logistic|||||1.97|0.85|0.228
73797565|NCT03022370|147141893|SUPERIORITY||Odds Ratio (OR)|0.86||||0.558|TWO_SIDED|95.0|0.53|1.41|||Regression, Logistic|||||1.41|0.53|0.558
73797566|NCT03022370|147141894|SUPERIORITY||Slope|0.14||||0.679|TWO_SIDED|95.0|-0.52|0.8|||Regression, Linear|||||0.80|-0.52|0.679
73797567|NCT03022370|147141894|SUPERIORITY||Slope|0.55||||0.08|TWO_SIDED|95.0|-0.07|1.16|||Regression, Linear|||||1.16|-0.07|0.08
73797568|NCT03022370|147141895|SUPERIORITY||Slope|-0.13||||0.81|TWO_SIDED|95.0|-1.21|0.95|||Regression, Linear|||||0.95|-1.21|0.810
73797569|NCT03022370|147141895|SUPERIORITY||Slope|-1.03||||0.041|TWO_SIDED|95.0|-2.01|-0.04|||Regression, Linear|||||-0.04|-2.01|0.041
73797570|NCT03022370|147141896|SUPERIORITY||Odds Ratio (OR)|1.14||||0.635|TWO_SIDED|95.0|0.67|1.92|||Regression, Logistic|||||1.92|0.67|0.635
73797571|NCT03022370|147141896|SUPERIORITY||Odds Ratio (OR)|0.72||||0.256|TWO_SIDED|95.0|0.41|1.27|||Regression, Logistic|||||1.27|0.41|0.256
73797572|NCT03022370|147141897|SUPERIORITY||Odds Ratio (OR)|1.16||||0.526|TWO_SIDED|95.0|0.73|1.84|||Regression, Logistic|||||1.84|0.73|0.526
73797573|NCT03022370|147141897|SUPERIORITY||Odds Ratio (OR)|1.02||||0.931|TWO_SIDED|95.0|0.67|1.56|||Regression, Logistic|||||1.56|0.67|0.931
73797574|NCT03022370|147141898|SUPERIORITY||Odds Ratio (OR)|0.92||||0.691|TWO_SIDED|95.0|0.63|1.36|||Regression, Logistic|||||1.36|0.63|0.691
73797575|NCT03022370|147141898|SUPERIORITY||Odds Ratio (OR)|0.92||||0.692|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||||1.40|0.60|0.692
73797576|NCT03022370|147141899|SUPERIORITY||Slope|-0.31||||0.137|TWO_SIDED|95.0|-0.72|0.24|||Regression, Linear|||||0.24|-0.72|0.137
73797577|NCT03022370|147141899|SUPERIORITY||Slope|-0.09||||0.721|TWO_SIDED|95.0|-0.58|0.4|||Regression, Linear|||||0.40|-0.58|0.721
73797578|NCT03022370|147141900|SUPERIORITY||Slope|-0.23||||0.332|TWO_SIDED|95.0|-0.7|0.24|||Regression, Linear|||||0.24|-0.70|0.332
73797579|NCT03022370|147141900|SUPERIORITY||Slope|-0.19||||0.468|TWO_SIDED|95.0|-0.71|0.32|||Regression, Linear|||||0.32|-0.71|0.468
73797580|NCT03022370|147141901|SUPERIORITY||Odds Ratio (OR)|1.3||||0.174|TWO_SIDED|95.0|0.89|1.9|||Regression, Logistic|||||1.90|0.89|0.174
73797581|NCT03022370|147141901|SUPERIORITY||Odds Ratio (OR)|1.49||||0.129|TWO_SIDED|95.0|0.89|2.5|||Regression, Logistic|||||2.50|0.89|0.129
73797582|NCT03022370|147141902|SUPERIORITY||Odds Ratio (OR)|1.3||||0.174|TWO_SIDED|95.0|0.89|1.9|||Regression, Logistic|||||1.90|0.89|0.174
73797583|NCT03022370|147141902|SUPERIORITY||Odds Ratio (OR)|0.96||||0.836|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||||1.43|0.64|0.836
73797584|NCT00699816|147141903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.01|TWO_SIDED|95.0|0.43|0.94|||Log Rank|||||0.94|0.43|0.01
73797585|NCT00699816|147141904|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21||||0.008|TWO_SIDED|95.0|0.06|0.75|||Log Rank|||||0.75|0.06|0.008
73797586|NCT00699816|147141905|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.19||||0.02|TWO_SIDED|95.0|0.04|0.87|||Log Rank|||||0.87|0.04|0.02
73797587|NCT01311687|147141910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.35|0.59|||Stratified Log Rank Test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.59|0.35|<0.001
73797588|NCT01311687|147141911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.39|0.61|||Stratified log-rank test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.61|0.39|<0.001
73797589|NCT01311687|147141913|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.37|0.74|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.74|0.37|<0.001
73797590|NCT01311687|147141914|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.009|TWO_SIDED|95.0|0.54|0.92|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.92|0.54|0.009
73797591|NCT01311687|147141915|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.91|0.60|0.005
73797592|NCT01311687|147141916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.53|||<|0.001|TWO_SIDED|95.0|3.19|17.77|||Fisher Exact||Odds ratio is for pomalidomide plus low-dose dexamethasone : high dose dexamethasone|||17.77|3.19|< 0.001
73797593|NCT01311687|147141917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.44|||<|0.001|TWO_SIDED|95.0|3.32|21.42|||Fisher Exact||Odds ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||21.42|3.32|< 0.001
73797594|NCT01311687|147141918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.36|0.59|||Stratified Log Rank Test|Stratified by age, diseases population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.59|0.36|< 0.001
73797595|NCT03668808|147141935|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in Time in Range (70-140mg/dl) in the initial 24 hours at destination, whether after Eastward travel or Westward travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance set at 0.05; using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
73797596|NCT03668808|147141936|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||Null hypothesis is there was no difference in Time in Range (70-180mg/dl) in the initial 24 hours at destination, whether after Eastward travel or Westward travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance set at 0.05; using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
73797597|NCT03668808|147141937|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in Mean ± SD CGM glucose (mg/dl) in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
73892512|NCT04881942|147317996|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|1678.4||||0.0031|TWO_SIDED|95.0|592.14|2764.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||2764.6|592.14|.0031
73797598|NCT03668808|147141938|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time \<70 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
73797599|NCT03668808|147141939|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time 70-180 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
73797600|NCT03668808|147141940|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time \>180 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
73797601|NCT03668808|147141941|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in CGM - Coefficient of Variation (CV) in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
73797602|NCT03668808|147141942|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in CGM Fasting Blood Glucose (FBG) at 0600 local time at destination, whether after East or West travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. Criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
73797603|NCT03668808|147141943|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in Liverpool Jet-Lag Questionnaire after 24 and 48 hours at the destination, whether after Eastward travel or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.01
73797604|NCT03668808|147141944|SUPERIORITY||||||<|0.05||||||The tests were performed with a significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in Sleep quantity measured by ActiGraph in 24 hours at the destination, whether after Eastward or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.05
73797605|NCT03668808|147141945|SUPERIORITY||||||<|0.05||||||The tests were performed with a significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is there was no difference in Sleep efficiency measured by ActiGraph in 24 hours at the destination, whether after Eastward or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.05
73797606|NCT01526655|147141946|SUPERIORITY|||||||0.011||||||Main effect over time p\<0.001; Interaction effect p=0.65. Threshold for statistical significance p\<0.05|ANOVA|||||||0.011
73797607|NCT01526655|147141947|SUPERIORITY|||||||0.03||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p 0.02.~Threshold for statistical significance p\<0.05."|ANOVA||||Tukey post hoc test (p-values): hsCRP time 4 p 0.02; hsCRP time 5 p \<0.001.|||0.03
73797608|NCT01526655|147141948|SUPERIORITY||||||<|0.01||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.0001.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): WBC time 3 p \< 0.0001.|||<0.01
73797609|NCT01526655|147141949|SUPERIORITY|||||||0.03|||||||ANOVA||||Tukey post hoc test (p-value): IL-6 time 3 p \< 0.01.|||0.03
73797610|NCT01526655|147141950|SUPERIORITY|||||||0.03||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.01.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): CK time 4 p \< 0.0001.|||0.03
73797611|NCT01526655|147141951|SUPERIORITY|||||||0.06||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.01.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): cortisol time 3 p \< 0.0001.|||0.06
73797612|NCT01526655|147141952|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
73797613|NCT01526655|147141953|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
73797614|NCT02288325|147141958|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0212|TWO_SIDED|95.0|0.33|0.92|||Log Rank|||||0.92|0.33|0.0212
73797615|NCT04020887|147141960|SUPERIORITY||Median Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-6.01|18.01||||||Difference in time to PACU discharge determination from observation to interaction phase \[ Time Frame: 6 months\]: The difference in discharge readiness time between the observation and interaction phases will be compared.||18.01|-6.01|
73797616|NCT04020887|147141961|SUPERIORITY||Difference Between Proportions|29.8|||||TWO_SIDED|95.0|23.82|35.66||||||||35.66|23.82|
73797617|NCT04020887|147141962|SUPERIORITY||Difference Between Proportions|-2.67|||||TWO_SIDED|95.0|-8.18|3.02||||||||3.02|-8.18|
73797618|NCT04020887|147141963|SUPERIORITY||Difference Between Proportions|13.03|||||TWO_SIDED|95.0|5.16|20.79||||||||20.79|5.16|
73797619|NCT04020887|147141964|SUPERIORITY||Difference Between Proportions|0.51|||||TWO_SIDED|95.0|-1.63|3.07||||||||3.07|-1.63|
73797620|NCT04020887|147141965|SUPERIORITY||Difference Between Proportions|7.9|||||TWO_SIDED|95.0|3.13|12.71||||||||12.71|3.13|
73797621|NCT04807400|147142054|SUPERIORITY||Least Squares Mean|-31.8|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-37.91|-25.77||p-values are adjusted using Holm's procedure.|ANCOVA|||||-25.77|-37.91|<0.001
73797622|NCT04807400|147142054|SUPERIORITY||Least Squares Mean|-32.1|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-38.35|-25.94||p-values are adjusted using Holm's procedure.|ANCOVA|||||-25.94|-38.35|<0.001
73797623|NCT04807400|147142056|SUPERIORITY||Least-squares Mean|1.4|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|0.62|2.13|||ANOVA|||||2.13|0.62|<0.001
73797624|NCT04807400|147142056|SUPERIORITY||Least-squares Mean|1.3|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|0.6|2.1|||ANOVA|||||2.10|0.60|<0.001
73797625|NCT04807400|147142057|SUPERIORITY||Least-squares Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.326||0.9347|TWO_SIDED|95.0|-0.67|0.61|||ANOVA|||||0.61|-0.67|0.9347
73797626|NCT04807400|147142058|SUPERIORITY||Least-squares Mean|1.0|STANDARD_ERROR_OF_MEAN|2.34||0.6759|TWO_SIDED|95.0|-3.62|5.58|||ANCOVA|||||5.58|-3.62|0.6759
73797627|NCT04807400|147142058|SUPERIORITY||Least-squares Mean|1.3|STANDARD_ERROR_OF_MEAN|2.31||0.5756|TWO_SIDED|95.0|-3.25|5.84|||ANCOVA|||||5.84|-3.25|0.5756
73892513|NCT04881942|147317996|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|1199.7||||0.031|TWO_SIDED|95.0|113.74|2285.7|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||2285.7|113.74|.0310
73797628|NCT04807400|147142059|SUPERIORITY||Least-squares Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69||0.858|TWO_SIDED|95.0|-3.02|3.62|||ANCOVA|||||3.62|-3.02|0.8580
73797629|NCT01330303|147142098|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.89||||||90.0|94.91|109.39|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||109.39|94.91|
73797630|NCT01330303|147142099|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.91||||||90.0|95.0|109.33|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||109.33|95.00|
73797631|NCT01330303|147142100|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.04||||||90.0|86.33|102.44|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||102.44|86.33|
73892514|NCT04881942|147317996|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|3354.5|||<|0.0001|TWO_SIDED|95.0|2266.6|4442.3|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||4442.3|2266.6|<.0001
73892515|NCT04881942|147317996|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|2511.0|||<|0.0001|TWO_SIDED|95.0|1416.1|3605.9|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3605.9|1416.1|<.0001
73797632|NCT03956355|147142113|SUPERIORITY||Risk Ratio (RR)|5.78|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
73797633|NCT03956355|147142114|SUPERIORITY||Risk Ratio (RR)|2.76|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
73797634|NCT03956355|147142115|SUPERIORITY||Risk Ratio (RR)|2.68||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
73797635|NCT03956355|147142116|SUPERIORITY||Least squares mean difference|-3.28|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73797636|NCT03956355|147142117|SUPERIORITY||Risk Ratio (RR)|8.54||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0005
73797637|NCT00733005|147142217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||95.0|||||ANCOVA|||||||0.102
73797638|NCT00733005|147142218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0|||||ANCOVA|||||||0.019
73797639|NCT00266630|147142219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|||||TWO_SIDED|95.0|-4.1|-1.9||||||||-1.90|-4.10|
73797640|NCT00266630|147142223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8|||||TWO_SIDED|95.0|-25.58|-14.06||||||||-14.06|-25.58|
73797641|NCT02548156|147142269|SUPERIORITY_OR_OTHER||Ratio of LS mean|1.52|||<|0.0001|TWO_SIDED|95.0||||From ANCOVA of log transformed data: subject (random), treatment (fixed) and period (fixed) as factors, participant-level baseline and period-level baseline minus participant-level baseline as covariates.|ANCOVA||Treatment difference from ANCOVA of log transformed data. This therefore represents the ratio of the first named treatment to the second named treatment. A ratio \>1 favors the first named treatment.|Test and Reference dentifrice combined vs. Comparator dentifrice||||<0.0001
73797642|NCT01983566|147142273|NON_INFERIORITY_OR_EQUIVALENCE|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|115.8||||0.3944|TWO_SIDED|90.0|63.52|211.11||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% confidence interval (CI) based on the t-distribution was computed.~These were then back transformed. The estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."||211.11|63.52|0.3944
73797643|NCT01983566|147142274|NON_INFERIORITY_OR_EQUIVALENCE|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|114.83||||0.3674|TWO_SIDED|90.0|74.803|176.281||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% CI based on the t-distribution was computed.~These were then back transformed. This estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."||176.281|74.803|0.3674
73797644|NCT01068262|147142276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.2|||||TWO_SIDED|90.0|50.9|80.2|||Linear mixed effect model|Back-transformed least squares estimates and confidence intervals from a linear mixed effect model were performed on natural log-transformed values.||||80.2|50.9|
73797645|NCT01068262|147142276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-14.7|14.9|||Linear mixed effects model|Back-transformed least squares estimates and confidence intervals from a linear mixed effect model were performed on natural log-transformed values.||||14.9|-14.7|
73797646|NCT01068262|147142277|SUPERIORITY_OR_OTHER||Estimate|0.9|||||TWO_SIDED|90.0|0.75|1.07||Hypothesis: Following 4 weeks of Qw oral dosing of Odanacatib 50 mg, there is no clinically important difference in the true GMR (male/postmenopausal female) of the AUC0-168hr. The GMR is contained within the interval (0.4, 2.0).|Geometric Mean Ratio (GMR); male/female|||||1.07|0.75|
73797647|NCT01068262|147142278|SUPERIORITY_OR_OTHER||GMR|0.93|||||TWO_SIDED|90.0|0.82|1.04|||GMR|||||1.04|0.82|
73797648|NCT01068262|147142279|SUPERIORITY_OR_OTHER||Estimate|0.95|||||TWO_SIDED|90.0|0.66|1.35|||GMR|||||1.35|0.66|
73797649|NCT01473407|147142306|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|95.0|-0.25|0.01||||||Least Square (LS) mean and 95 percent confidence interval (CI) were derived from an ANCOVA model with fixed effect of treatment.||0.01|-0.25|
73797650|NCT01473407|147142307|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|5.483|||TWO_SIDED|95.0|-10.4|11.13||||||LS mean and 95 percent CI were derived from an ANCOVA model with fixed effect of treatment.||11.13|-10.40|
73797651|NCT01473407|147142308|SUPERIORITY_OR_OTHER|||||||0.7563||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.7563
73797652|NCT01473407|147142309|SUPERIORITY_OR_OTHER|||||||0.1061||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.1061
73797653|NCT01473407|147142310|SUPERIORITY_OR_OTHER|||||||0.3369||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.3369
73797654|NCT01027702|147142331|OTHER|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~1. Probability of CD4+ cells \> 100/µL by Day +120 is at least 66% and~2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~* If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~* If none of the initial three patients at a dose level experienced grade II/III GVHD and \< 2/3 had a CD4+ count \> 100 at Day +120, the next three patients were assigned to the next higher dose level.~* If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \> 2/3 have a CD4+ count \> 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10\^4 CD3+ cells/kg was determined to be the optimal dose."|||
73797655|NCT01027702|147142332|OTHER|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~1. Probability of CD4+ cells \> 100/µL by Day +120 is at least 66% and~2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~If none of the initial three patients at a dose level experienced grade II/III GVHD and \< 2/3 had a CD4+ count \> 100 at Day +120, the next three patients were assigned to the next higher dose level.~If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \> 2/3 have a CD4+ count \> 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10\^4 CD3+ cells/kg was determined to be the optimal dose."|||
73797656|NCT01153425|147142343|OTHER|unpaired t-test for the difference of the means between the two arms|||||>|0.05|||||||t-test, 2 sided|||paired t-test for change from baseline to 24 months||||>0.05
73797657|NCT02932462|147142344|SUPERIORITY|||||||0.4557|||||||Cochran-Mantel-Haenszel|||||||0.4557
73797658|NCT02932462|147142345|SUPERIORITY|||||||0.8096|||||||Cochran-Mantel-Haenszel|||||||0.8096
73797659|NCT02932462|147142346|SUPERIORITY|||||||0.7652|||||||Cochran-Mantel-Haenszel|||||||0.7652
73797660|NCT02652949|147142347|SUPERIORITY||Event rate|0.023|||<|0.0001|ONE_SIDED|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p \<16%, where p denotes the true event rate of primary study endpoint in the target population."||0.081||<0.0001
73797661|NCT05274178|147142355|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>.05
73797662|NCT05274178|147142355|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>.05
73797663|NCT02839772|147142358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.581|STANDARD_ERROR_OF_MEAN|0.296|<|0.001|TWO_SIDED|95.0|0.997|2.164|||Mixed Models Analysis|t=5.341, df=89.347||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function (SBF) in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the outer lower legs by group from baseline after 3 months of interventions."||2.164|0.997|<0.001
73797664|NCT02839772|147142359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.684|STANDARD_ERROR_OF_MEAN|0.346|<|0.001|TWO_SIDED|95.0|1.002|2.367|||Mixed Models Analysis|t=4.871, df=189.789||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."||2.367|1.002|<0.001
73797665|NCT02839772|147142360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|0.386|<|0.001|TWO_SIDED|95.0|1.21|2.731|||Mixed Models Analysis|t=5.111, df=189.620||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the base of the outer lower legs by group from baseline after 3 months of interventions."||2.731|1.210|<0.001
73797666|NCT02839772|147142361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.751|STANDARD_ERROR_OF_MEAN|0.39||0.002|TWO_SIDED|95.0|0.656|2.846|||Mixed Models Analysis|t=3.154, df=189.580||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the feet by group from baseline after 3 months of interventions."||2.846|0.656|0.002
73797667|NCT02839772|147142362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.075|STANDARD_ERROR_OF_MEAN|0.515|<|0.001|TWO_SIDED|95.0|-3.042|-1.1078|||Mixed Models Analysis|t=-4.236,df=165.310||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the top of the outer lower legs by group from baseline after 3 months of interventions."||-1.1078|-3.042|<0.001
73797668|NCT02839772|147142363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.658|STANDARD_ERROR_OF_MEAN|0.467|<|0.001|TWO_SIDED|95.0|-2.581|-0.736|||Mixed Models Analysis|t=-3.549, df=180.923||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."||-0.736|-2.581|<0.001
73797669|NCT02839772|147142364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.641|STANDARD_ERROR_OF_MEAN|0.473||0.001|TWO_SIDED|95.0|-2.574|-0.708|||Mixed Models Analysis|t=-3.471, df=186.308||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the outer lower legs by group from baseline after 3 months of interventions."||-0.708|-2.574|0.001
73797670|NCT02839772|147142365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.041|STANDARD_ERROR_OF_MEAN|0.572|<|0.001|TWO_SIDED|95.0|-3.168|-0.911|||Mixed Models Analysis|t=-3.565, df=186.739||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the top of the feet by group from baseline after 3 months of interventions."||-0.911|-3.168|<0.001
73797671|NCT02839772|147142366|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.452|STANDARD_ERROR_OF_MEAN|0.255||0.076|TWO_SIDED|95.0|-0.048|0.952||A cumulative logistic link function was used|Generalized estimating equation analysis|Wald Chi squared=3.138, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of the stage of podoconiosis by group being more severe at the 4th visit."||0.952|-0.048|0.076
73797672|NCT02839772|147142367|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.224||||0.527|TWO_SIDED|95.0|-0.469|0.917||A Bernouilli distribution with a logistic link function was used.|Generalized estimating equation analysis|Wald chi-square=0.410, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of mossy changes being present in the lower legs/feet by group at the 4th visit."||0.917|-0.469|0.527
73797673|NCT02839772|147142368|SUPERIORITY_OR_OTHER||Odds Ratio, log|-1.29|STANDARD_ERROR_OF_MEAN|0.446||0.031|TWO_SIDED|95.0|-2.161|-0.411||A Bernouilli distribution with a logistic link function was used|Generalized estimating equation analysis|Wald chi-square=8.304, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of participants having a bad odour emanating from their lower legs/feet by group at the 4th visit. Bad odour results in a decease in quality of life."||-0.411|-2.161|0.031
73797674|NCT02839772|147142369|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.062|STANDARD_ERROR_OF_MEAN|0.741||0.005|TWO_SIDED|95.0|0.61|3.514||A Poisson distribution with a logarithmic link function was used|Generalized estimating equation analysis|Wald chi-square=7.745, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of wounds being present on the lower legs/feet of participants by group at the 4th visit."||3.514|0.610|0.005
73797675|NCT02839772|147142370|SUPERIORITY_OR_OTHER||Group ratio estimate|2.09|STANDARD_ERROR_OF_MEAN|1.102||0.058|TWO_SIDED|0.058|-0.069|4.25||A Poisson distribution with a logarithmic link function was used.|Generalized estimation equation|df=1|Those in the experimental group were expected to have fewer work days lost due to ADL.|"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds by group of having had fewer work days lost in the previous month at the 4th visit due to ADL."||4.250|-0.069|0.058
73797676|NCT02839772|147142371|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value was \< 0.001 at all time points.|Spearman's correlation coefficient|The correlation at the 1st visit was 0.252, at the 2nd 0.306, at the 3rd 0.291 and at the 4th 0.265.||The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.||||<0.001
73797677|NCT02839772|147142372|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.204||0.158|TWO_SIDED|95.0|-0.113|0.69|||Mixed Models Analysis|df=185.386||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in leg circumference indicates an improvement in the disease."||0.690|-0.113|0.158
73797678|NCT02839772|147142373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.575|STANDARD_ERROR_OF_MEAN|0.162|<|0.001|TWO_SIDED|95.0|0.255|0.895|||Mixed Models Analysis|df=169.916, t=3.550||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in foot circumference indicates an improvement in the disease."||0.895|0.255|<0.001
73797679|NCT02839772|147142374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.54||0.907|TWO_SIDED|95.0|-1.129|1.002|||Mixed Models Analysis|t=-0.117, df=178.814||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Podoconiosis has a large effect on a person's quality of life. abnormal looking legs/feet, wounds and the related bad odour plus social isolation result in stigma and social isolation.."||1.002|-1.129|0.907
73797680|NCT01895777|147142444|NON_INFERIORITY|Non-inferiority margin of 20%|Difference in Rates|-0.038|||=|0.0001|TWO_SIDED|90.0|-0.141|0.066||p-value for non-inferiority is actually \<0.0001|Cochran-Mantel-Haenszel||Difference in rates (SOC - DE)|The primary analysis of the primary efficacy endpoint used the randomised set, following the intention-to-treat principle, based on adjudication-confirmed data. Age group was used as stratification factor using a Mantel-Haenszel type weighted average of differences.||0.066|-0.141|= 0.0001
73797681|NCT01895777|147142445|OTHER||Kaplan-Meier estimate|0.0|||||TWO_SIDED|90.0|-0.032|0.032|||Kaplan-Meier estimate||Kaplan-Meier estimate of rate difference.|Time-to event endpoint using Kaplan-Meier estimates based on adjudication-confirmed data. Due to the low event rate of major bleeding, age group stratification was not considered.||0.032|-0.032|
73797682|NCT01895777|147142451|OTHER||Hazard Ratio (HR)|1.145|||||TWO_SIDED|90.0|0.736|1.78||||||Any bleeding events was analysed as time-to-event endpoint using a stratified Cox proportional hazard model with treatment as a covariate in the model and age group as the stratification factor. A pooling of age groups was performed as no events were observed in certain age group.||1.780|0.736|
73797683|NCT01895777|147142452|OTHER||Hazard Ratio (HR)|69990000.0||||0.9976|TWO_SIDED|90.0|0.0|999999999.0|||Cox proportional hazard model||Upper Limit of the 90% confidence interval was not assessable|All-cause mortality was analyzed as time-to-event endpoint using a stratified Cox proportional hazard model with treatment as a covariate in the model.||999999999|0.000|0.9976
73797684|NCT01965860|147142458|SUPERIORITY|||||||0.001|||||||ANOVA|||"Prior to the study a power analysis was performed to calculate the number of participants required in each of the three groups. Previous work comparing OSATS derived scores in endovascular interventions shows a Cohen D of two. Using a of .05, a power of .80, and an expected dropout rate of 10%, the minimum number of surgical trainees required per group was seven.~Null hypothesis for primary outcome: no difference in technical performance during real life procedures between the three groups"||||0.001
73797685|NCT01965860|147142458|OTHER|||||||0.003|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.003
73797686|NCT01965860|147142458|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.001
73797687|NCT01965860|147142458|OTHER|||||||0.228|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.228
73797688|NCT01965860|147142458|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.001
73797689|NCT01965860|147142458|OTHER|||||||0.008|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.008
73797690|NCT01965860|147142458|OTHER|||||||0.164|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.164
73797691|NCT01965860|147142458|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.001
73797692|NCT01965860|147142458|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.001
73797693|NCT01965860|147142458|OTHER|||||||0.19|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.190
73797694|NCT03735121|147142462|NON_INFERIORITY|The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% confidence interval \[CI\] of the geometric mean ratio is greater than or equal to (≥) the non-inferiority margin 0.8.|Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.88|1.24||||||||1.24|0.88|
73797695|NCT03735121|147142463|NON_INFERIORITY|The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% CI of the geometric mean ratio is ≥ the non-inferiority margin 0.8.|Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.83|0.92||||||||0.92|0.83|
73797696|NCT03656744|147142516|SUPERIORITY|||||||0.199|||||||ANCOVA|||||||0.199
73797697|NCT03656744|147142516|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
73797698|NCT03656744|147142517|SUPERIORITY|||||||0.152|||||||ANCOVA|||||||0.152
73797699|NCT03656744|147142517|SUPERIORITY|||||||0.109|||||||ANCOVA|||||||0.109
73797700|NCT03656744|147142518|SUPERIORITY|||||||0.034|||||||ANCOVA|||||||0.034
73797701|NCT03656744|147142518|SUPERIORITY|||||||0.004|||||||ANCOVA|||||||0.004
73797702|NCT03656744|147142519|SUPERIORITY|||||||0.884|||||||Regression, Logistic|||||||0.884
73797703|NCT03656744|147142519|SUPERIORITY|||||||0.236|||||||Regression, Logistic|||||||0.236
73797704|NCT03656744|147142520|SUPERIORITY|||||||0.196|||||||ANCOVA|||||||0.196
73797705|NCT03656744|147142520|SUPERIORITY|||||||0.016|||||||ANCOVA|||||||0.016
73797706|NCT03656744|147142521|SUPERIORITY|||||||0.294|||||||Cochran-Mantel-Haenszel|||||||0.294
73797707|NCT03656744|147142522|SUPERIORITY|||||||0.287|||||||Regression, Logistic|||||||0.287
73797708|NCT03656744|147142522|SUPERIORITY|||||||0.09|||||||Regression, Logistic|||||||0.090
73797709|NCT03656744|147142523|SUPERIORITY|||||||0.201|||||||ANCOVA|||||||0.201
73797710|NCT03656744|147142523|SUPERIORITY|||||||0.534|||||||ANCOVA|||||||0.534
73797711|NCT03656744|147142524|SUPERIORITY|||||||0.955|||||||ANCOVA|||||||0.955
73797712|NCT03656744|147142524|SUPERIORITY|||||||0.072|||||||ANCOVA|||||||0.072
73797713|NCT03656744|147142525|SUPERIORITY|||||||0.041|||||||ANCOVA|||||||0.041
73797714|NCT03656744|147142525|SUPERIORITY|||||||0.12|||||||ANCOVA|||||||0.120
73797715|NCT03656744|147142526|SUPERIORITY|||||||0.955|||||||ANCOVA|||||||0.955
73797716|NCT03656744|147142526|SUPERIORITY|||||||0.072|||||||ANCOVA|||||||0.072
73797717|NCT03656744|147142527|SUPERIORITY|||||||0.488|||||||ANCOVA|||||||0.488
73797718|NCT03656744|147142527|SUPERIORITY|||||||0.022|||||||ANCOVA|||||||0.022
73797719|NCT03656744|147142528|SUPERIORITY|||||||0.674|||||||ANCOVA|||||||0.674
73797720|NCT03656744|147142528|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.030
73797721|NCT03656744|147142529|SUPERIORITY|||||||0.588|||||||Regression, Logistic|||||||0.588
73797722|NCT03656744|147142529|SUPERIORITY|||||||0.103|||||||Regression, Logistic|||||||0.103
73797723|NCT03656744|147142530|SUPERIORITY|||||||0.236|||||||ANCOVA|||||||0.236
73797724|NCT03656744|147142530|SUPERIORITY|||||||0.944|||||||ANCOVA|||||||0.944
73797725|NCT03656744|147142531|SUPERIORITY|||||||0.267|||||||ANCOVA|||||||0.267
73797726|NCT03656744|147142531|SUPERIORITY|||||||0.911|||||||ANCOVA|||||||0.911
73797727|NCT03656744|147142532|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.387
73797728|NCT03656744|147142532|SUPERIORITY|||||||0.855|||||||ANCOVA|||||||0.855
73797729|NCT03656744|147142533|SUPERIORITY|||||||0.107|||||||ANCOVA|||||||0.107
73797730|NCT03656744|147142533|SUPERIORITY|||||||0.489|||||||ANCOVA|||||||0.489
73797731|NCT03656744|147142534|SUPERIORITY|||||||0.515|||||||ANCOVA|||||||0.515
73797732|NCT03656744|147142534|SUPERIORITY|||||||0.887|||||||ANCOVA|||||||0.887
73797733|NCT03656744|147142535|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
73797734|NCT03656744|147142535|SUPERIORITY|||||||0.016|||||||ANCOVA|||||||0.016
73797735|NCT03656744|147142536|SUPERIORITY|||||||0.124|||||||ANCOVA|||||||0.124
73797736|NCT03656744|147142536|SUPERIORITY|||||||0.171|||||||ANCOVA|||||||0.171
73797737|NCT03295630|147142545|OTHER||Mean Difference (Final Values)|-17.7|||||TWO_SIDED|||||||||Difference (steps) between accelerometer quantified step count (thigh placement) and observed step count||||
73797738|NCT03295630|147142545|OTHER||Intraclass Correlation Coefficient|0.46|||||TWO_SIDED|95.0|-0.1|0.78||||||Correlation between accelerometer quantified step count (thigh placement) and observed step count||0.78|-0.1|
73797739|NCT03295630|147142545|OTHER||Mean Difference (Final Values)|-0.84|||||TWO_SIDED|||||||||Difference (steps) between accelerometer quantified steps (ankle placement) and observed step count||||
73797740|NCT03295630|147142545|OTHER||Intraclass Correlation Coefficient|0.99|||||TWO_SIDED|95.0|0.99|1.0||||||Correlation between accelerometer quantified steps (ankle placement) and observed steps||1.0|0.99|
73797741|NCT01277211|147142576|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Pearl Indices|0.61||||0.531|TWO_SIDED|95.0|0.19|2.29|||Poisson distribution method|Differences between treatment groups was explored using an exact 95% CI for the ratio of the two Pearl Indices based on the Poisson distribution.||Differences between the two treatment groups (ENG-EE vs. DRSP-EE) were explored using an exact 95% CI for the Ratio of the two Pearl Indices based on the Poisson distribution.||2.29|0.19|0.531
73797742|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 1|-3.0||||0.346|TWO_SIDED|95.0|-9.9|3.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||3.1|-9.9|0.346
73797743|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 2|-6.2||||0.029|TWO_SIDED|95.0|-12.7|-0.6|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.6|-12.7|0.029
73797744|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 3|-5.8||||0.019|TWO_SIDED|95.0|-11.8|-0.9|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.9|-11.8|0.019
73797745|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 4|-8.0||||0.001|TWO_SIDED|95.0|-14.0|-2.9|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.9|-14.0|0.001
73797746|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 5|-1.3||||0.556|TWO_SIDED|95.0|-6.4|2.6|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.6|-6.4|0.556
73797747|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 6|-3.9||||0.089|TWO_SIDED|95.0|-9.5|0.5|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.5|-9.5|0.089
73797748|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 7|-3.7||||0.11|TWO_SIDED|95.0|-9.4|0.8|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.8|-9.4|0.110
73797749|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 8|-4.3||||0.049|TWO_SIDED|95.0|-9.8|0.0|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.0|-9.8|0.049
73797750|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 9|-1.1||||0.621|TWO_SIDED|95.0|-6.2|2.9|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.9|-6.2|0.621
73797751|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 10|-4.4||||0.041|TWO_SIDED|95.0|-10.0|-0.2|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.2|-10.0|0.041
73797752|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 11|-3.8||||0.046|TWO_SIDED|95.0|-8.9|-0.1|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-8.9|0.046
73797753|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 12|-4.4||||0.037|TWO_SIDED|95.0|-9.9|-0.2|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.2|-9.9|0.037
73797754|NCT01277211|147142577|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 13|-4.5||||0.048|TWO_SIDED|95.0|-10.4|0.0|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.0|-10.4|0.048
73797755|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 1|-6.0||||0.015|TWO_SIDED|95.0|-12.0|-1.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.1|-12.0|0.015
73797756|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 2|-4.9||||0.012|TWO_SIDED|95.0|-10.1|-1.0|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.0|-10.1|0.012
73797757|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 3|-6.5||||0.002|TWO_SIDED|95.0|-12.0|-2.2|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.2|-12.0|0.002
73797758|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 4|-3.6||||0.044|TWO_SIDED|95.0|-8.5|-0.1|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-8.5|0.044
73797759|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 5|-1.0||||0.609|TWO_SIDED|95.0|-5.7|2.5|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.5|-5.7|0.609
73797760|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 6|-3.9||||0.062|TWO_SIDED|95.0|-9.3|0.2|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.2|-9.3|0.062
73797761|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 7|-4.1||||0.019|TWO_SIDED|95.0|-9.0|-0.6|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.6|-9.0|0.019
73797762|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 8|-1.9||||0.308|TWO_SIDED|95.0|-6.7|1.6|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||1.6|-6.7|0.308
73797763|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 9|-4.2||||0.027|TWO_SIDED|95.0|-9.3|-0.4|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.4|-9.3|0.027
73797764|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 10|-2.9||||0.098|TWO_SIDED|95.0|-7.6|0.5|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.5|-7.6|0.098
73797765|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 11|-4.4||||0.009|TWO_SIDED|95.0|-9.4|-1.0|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.0|-9.4|0.009
73797766|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 12|-6.2||||0.002|TWO_SIDED|95.0|-11.7|-2.1|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.1|-11.7|0.002
73797767|NCT01277211|147142578|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 13|-4.5||||0.043|TWO_SIDED|95.0|-10.2|-0.1|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-10.2|0.043
73797768|NCT00879086|147142579|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-16.7|||=|0.0941|TWO_SIDED|95.0|-36.1|2.4||The two treatment groups were compared, controlling for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (less than or equal to 3 or greater than 3), with both covariates included as binary variables.|Cochran-Mantel-Haenszel||Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)|||2.4|-36.1|=0.0941
73797769|NCT00879086|147142580|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-18.4||||0.0492|TWO_SIDED|95.0|-36.0|-0.3||Controlled for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3), with both covariates included as binary variables.|Cochran-Mantel-Haenszel||Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)|||-0.3|-36.0|0.0492
73797770|NCT01866098|147142597|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.83
73797771|NCT01866098|147142598|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
73892516|NCT04881942|147317999|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.25||||0.0002|TWO_SIDED|95.0|0.12|0.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.38|0.12|.0002
73797772|NCT01866098|147142599|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.19
73797773|NCT01866098|147142600|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.96
73797774|NCT01866098|147142601|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.92
73797775|NCT01866098|147142602|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.98
73797776|NCT01866098|147142603|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.95
73797777|NCT01866098|147142604|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.43
73797778|NCT03649347|147142605|SUPERIORITY||||||<|0.001||||||Interaction effect: p\<.001, np2=.720|ANOVA|Main effect of time: p\<.001, np2=.798; main effect of group: p\<.001, np2=.711||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=4.76.||||<.001
73797779|NCT03649347|147142606|SUPERIORITY||||||<|0.001||||||Interaction effect: p\<.001, np2=.542|ANOVA|Main effect of time: p\<.001, np2=.598; and main effect of group: p\<.001, np2=.439||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 96%, critical F=4.76.||||<.001
73797780|NCT03649347|147142608|SUPERIORITY||||||<|0.005||||||Interaction effect: p\<.005, np2=.481|ANOVA|Main effect of time: p\<.001, np2=.572; and main effect of group p\<.001, np2=.626||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=3.49.||||<.005
73797781|NCT03449446|147142625|SUPERIORITY||Difference in percentages|0.6||||0.9449|TWO_SIDED|95.0|-17.6|18.8||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted Mantel-Haenszel (MH) method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.8|-17.6|0.9449
73797782|NCT03449446|147142625|SUPERIORITY||Difference in percentages|0.4||||0.9646|TWO_SIDED|95.0|-17.6|18.4||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.4|-17.6|0.9646
73797783|NCT03449446|147142625|SUPERIORITY||Difference in percentages|3.7||||0.6219|TWO_SIDED|95.0|-10.9|18.3||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.3|-10.9|0.6219
73797784|NCT03449446|147142625|SUPERIORITY||Difference in percentages|8.8||||0.2554|TWO_SIDED|95.0|-6.4|24.1||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||24.1|-6.4|0.2554
73797785|NCT03449446|147142625|SUPERIORITY||Difference in percentages|10.8||||0.1658|TWO_SIDED|95.0|-4.5|26.1||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.1|-4.5|0.1658
73797786|NCT03449446|147142625|SUPERIORITY||Difference in percentages|3.2||||0.6963|TWO_SIDED|95.0|-12.9|19.4||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||19.4|-12.9|0.6963
73797787|NCT03449446|147142625|SUPERIORITY||Difference in percentages|10.0||||0.2441|TWO_SIDED|95.0|-6.8|26.8||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.8|-6.8|0.2441
73797788|NCT03449446|147142625|SUPERIORITY||Difference in percentages|5.2||||0.5229|TWO_SIDED|95.0|-10.7|21.0||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||21.0|-10.7|0.5229
73797789|NCT03449446|147142625|SUPERIORITY||Difference in percentages|10.4||||0.2149|TWO_SIDED|95.0|-6.0|26.9||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.9|-6.0|0.2149
73797790|NCT02448368|147142626|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio|232.0|||||TWO_SIDED|90.0|202.0|266.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||266|202|
73892517|NCT04881942|147317999|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.25||||0.0003|TWO_SIDED|95.0|0.12|0.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.38|0.12|0.0003
73892518|NCT04881942|147317999|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.47|0.21|<.0001
73892519|NCT04881942|147317999|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.43|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.43|0.17|<.0001
73892520|NCT04881942|147318006|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Final Values)|0.035|||<|0.0001|TWO_SIDED|95.0|0.031|0.039|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.039|0.031|<.0001
73892521|NCT04881942|147318006|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.034|||<|0.0001|TWO_SIDED|95.0|0.03|0.038|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.038|0.030|<.0001
73892522|NCT04881942|147318006|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.04|||<|0.0001|TWO_SIDED|95.0|0.036|0.044|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.044|0.036|<.0001
73892523|NCT04881942|147318006|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.037|||<|0.0001|TWO_SIDED|95.0|0.033|0.041|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.041|0.033|<.0001
73892524|NCT04881942|147318007|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.036|||<|0.0001|TWO_SIDED|95.0|0.031|0.04|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.040|0.031|<.0001
73797791|NCT02448368|147142626|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|181.0|||||TWO_SIDED|90.0|164.0|200.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||200|164|
73892525|NCT04881942|147318007|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.036|||<|0.0001|TWO_SIDED|95.0|0.032|0.041|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.041|0.032|<.0001
73797792|NCT02448368|147142626|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|106.0|||||TWO_SIDED|90.0|91.5|124.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||124|91.5|
73797793|NCT02448368|147142628|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||TWO_SIDED|90.0|147.0|195.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||195|147|
73892526|NCT04881942|147318007|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.041|||<|0.0001|TWO_SIDED|95.0|0.037|0.046|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.046|0.037|<.0001
73892527|NCT04881942|147318007|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.038|||<|0.0001|TWO_SIDED|95.0|0.033|0.042|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.042|0.033|<.0001
73892528|NCT04881942|147318008|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.536|||<|0.0001|TWO_SIDED|95.0|0.407|0.665|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.665|0.407|<.0001
73892529|NCT04881942|147318008|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.408|||<|0.0001|TWO_SIDED|95.0|0.28|0.537|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.537|0.280|<.0001
73892530|NCT04881942|147318008|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.468|||<|0.0001|TWO_SIDED|95.0|0.339|0.596|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.596|0.339|<.0001
73892531|NCT04881942|147318008|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.43|||<|0.0001|TWO_SIDED|95.0|0.301|0.559|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.559|0.301|<.0001
73892532|NCT04881942|147318010|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|277.79|||<|0.0001|TWO_SIDED|95.0|213.62|341.96|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||341.96|213.62|<.0001
73892533|NCT04881942|147318010|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|241.32|||<|0.0001|TWO_SIDED|95.0|176.99|305.64|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||305.64|176.99|<.0001
73892534|NCT04881942|147318010|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|248.22|||<|0.0001|TWO_SIDED|95.0|184.01|312.43|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||312.43|184.01|<.0001
73892535|NCT04881942|147318010|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|257.92|||<|0.0001|TWO_SIDED|95.0|193.58|322.26|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||322.26|193.58|<.0001
73892536|NCT04881942|147318011|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.223|||<|0.0001|TWO_SIDED|95.0|1.915|2.58|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.580|1.915|<.0001
73892537|NCT04881942|147318011|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.203|||<|0.0001|TWO_SIDED|95.0|1.897|2.557|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.557|1.897|<.0001
73892538|NCT04881942|147318011|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.101|||<|0.0001|TWO_SIDED|95.0|1.81|2.439|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.439|1.810|<.0001
73892539|NCT04881942|147318011|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|2.052|||<|0.0001|TWO_SIDED|95.0|1.767|2.382|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.382|1.767|<.0001
73892540|NCT04881942|147318012|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|709.86|||<|0.0001|TWO_SIDED|95.0|549.19|870.54|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||870.54|549.19|<.0001
73892541|NCT04881942|147318012|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|568.35|||<|0.0001|TWO_SIDED|95.0|407.18|729.51|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||729.51|407.18|<.0001
73797794|NCT02448368|147142628|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||TWO_SIDED|90.0|146.0|199.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||199|146|
73797795|NCT02448368|147142628|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|129.0|||||TWO_SIDED|90.0|114.0|146.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||146|114|
73797796|NCT02448368|147142629|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|161.0|||||TWO_SIDED|90.0|139.0|187.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||187|139|
73797797|NCT02448368|147142629|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|159.0|||||TWO_SIDED|90.0|135.0|188.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||188|135|
73797798|NCT02448368|147142629|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|131.0|||||TWO_SIDED|90.0|116.0|147.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||147|116|
73797799|NCT02448368|147142631|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.4|||||TWO_SIDED|90.0|88.3|112.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||112|88.3|
73797800|NCT02448368|147142631|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.9|||||TWO_SIDED|90.0|85.5|117.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||117|85.5|
73797801|NCT02448368|147142631|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|116.0|||||TWO_SIDED|90.0|94.8|143.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||143|94.8|
73797802|NCT02448368|147142632|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|107.0|||||TWO_SIDED|90.0|98.3|116.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||116|98.3|
73797803|NCT02448368|147142632|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|104.0|||||TWO_SIDED|90.0|95.0|113.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||113|95.0|
73797804|NCT02448368|147142632|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|115.0|||||TWO_SIDED|90.0|95.3|140.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||140|95.3|
73797805|NCT02448368|147142633|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|107.0|||||TWO_SIDED|90.0|98.1|116.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||116|98.1|
73892542|NCT04881942|147318012|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|562.0|||<|0.0001|TWO_SIDED|95.0|401.34|722.67|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||722.67|401.34|<.0001
73892543|NCT04881942|147318012|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|517.23|||<|0.0001|TWO_SIDED|95.0|356.11|678.34|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||678.34|356.11|<.0001
73892544|NCT02105961|147318044|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.068|TWO_SIDED|95.0|0.65|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.65|0.068
73892545|NCT02105961|147318044|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.034|TWO_SIDED|95.0|0.65|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.65|0.034
73892546|NCT02105961|147318044|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|TWO_SIDED|95.0|0.7|1.05||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period|||1.05|0.70|0.140
73797806|NCT02448368|147142633|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|103.0|||||TWO_SIDED|90.0|94.6|113.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||113|94.6|
73892547|NCT02105961|147318044|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|TWO_SIDED|95.0|0.7|1.05||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.05|0.70|0.140
73892548|NCT02105961|147318045|SUPERIORITY||Hazard Ratio(Mepolizumab 100/Placebo)|0.82||||0.14|TWO_SIDED|95.0|0.64|1.04||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.04|0.64|0.140
73797807|NCT02448368|147142633|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|113.0|||||TWO_SIDED|90.0|93.3|137.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||137|93.3|
73797808|NCT01950390|147142671|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.383|ONE_SIDED|90.0||1.23||One-sided|Log Rank|Stratification factors of BRAF mutation status (wild type/mutation) and prior therapy (yes/no) were used in the stratified analysis|One-sided 90% Repeated Confidence Interval for Hazard Ratio with Arm A as Reference|||1.23||0.383
73797809|NCT01950390|147142672|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.358|TWO_SIDED|95.0|0.61|1.2||Two-sided|Log Rank|Stratified Log rank test||||1.20|0.61|0.358
73797810|NCT01950390|147142673|SUPERIORITY|||||||0.482||||||Two-sided|Chi-squared|||||||0.482
73797811|NCT01950390|147142675|SUPERIORITY|||||||0.937||||||Two-sided|Chi-squared|||||||0.937
73797812|NCT01682811|147142676|OTHER|||||||0.0001|||||||t-test, 1 sided|||One-sample t-test comparing the absolute value to an alternate expected value of zero.||||0.0001
73797813|NCT01682811|147142679|OTHER|||||||0.24|||||||t-test, 2 sided|||Paired comparisons between treated and placebo lesions within subject.||||0.24
73797814|NCT01682811|147142682|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
73797815|NCT01128179|147142683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1121||||0.3186|TWO_SIDED|95.0|-0.3389|0.1146||The a priori significance level was 5%. There was no adjustment for multiple comparisons.|ANCOVA|||Assuming that the natural logarithm transformed serum intact FGF-23 is normally distributed with a mean of 3.5 and a standard deviation of 0.46, 33 subjects randomised 2:1 (lanthanum carbonate to placebo) will be sufficient to detect with 80% power at the 5% 2-sided significance level a decrease of 0.5 in the mean difference (placebo minus lanthanum carbonate) of the log-transformed data at Week 12.||0.1146|-0.3389|0.3186
73797816|NCT01128179|147142684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.54||||0.2995|TWO_SIDED|95.0|-6.15|19.23||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of serum iPTH at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline iPTH as a covariate. The study was not powered for the analysis of this parameter.||19.23|-6.15|0.2995
73797817|NCT01128179|147142685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.11||||0.3252|TWO_SIDED|95.0|-5.36|15.57||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of 1,25-Dihydroxy Vitamin D at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline 1,25-Dihydroxy Vitamin D as a covariate. The study was not powered for the analysis of this parameter.||15.57|-5.36|0.3252
73797818|NCT01128179|147142686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.1459|TWO_SIDED|95.0|-8.845|1.403||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Urinary Fractional Excretion of Phosphate at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Urinary Fractional Excretion of Phosphate as a covariate. The study was not powered for the analysis of this parameter.||1.403|-8.845|0.1459
73797819|NCT01128179|147142687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0297||||0.6134|TWO_SIDED|95.0|-0.1492|0.0897||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Phosphate at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Phosphate as a covariate. The study was not powered for the analysis of this parameter||0.0897|-0.1492|0.6134
73797820|NCT01128179|147142688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0294||||0.5636|TWO_SIDED|95.0|-0.0739|0.1328||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Total Calcium at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Total Calcium as a covariate. The study was not powered for the analysis of this parameter.||0.1328|-0.0739|0.5636
73797821|NCT01128179|147142689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0129||||0.922|TWO_SIDED|95.0|-0.2811|0.2553||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Calcium-Phosphate Product at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Calcium-Phosphate Product as a covariate.||0.2553|-0.2811|0.9220
73892549|NCT02105961|147318045|SUPERIORITY||Hazard Ratio (Mepolizumab/Placebo)|0.82||||0.103|TWO_SIDED|95.0|0.64|1.04||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.04|0.64|0.103
73892550|NCT02105961|147318045|SUPERIORITY||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.14|TWO_SIDED|95.0|0.6|0.97||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.97|0.60|0.140
73892551|NCT02105961|147318045|SUPERIORITY||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.03|TWO_SIDED|95.0|0.6|0.97||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.97|0.60|0.030
73892552|NCT02105961|147318046|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.14|TWO_SIDED|95.0|0.35|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.35|0.140
73892553|NCT02105961|147318046|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.042|TWO_SIDED|95.0|0.35|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.35|0.042
73892554|NCT02105961|147318046|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|TWO_SIDED|95.0|0.51|1.34||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.34|0.51|0.447
73892555|NCT02105961|147318046|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|TWO_SIDED|95.0|0.51|1.34||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.34|0.51|0.447
73892556|NCT02105961|147318047|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.447|TWO_SIDED|95.0|-4.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-4.5|0.447
73797822|NCT02731638|147142699|SUPERIORITY||Odds Ratio (OR)|1.82||||0.26|TWO_SIDED|95.0|0.65|5.23|||Regression, Logistic|Bias-corrected logistic regression, accounting for baseline culture status||||5.23|0.65|0.26
73892557|NCT02105961|147318047|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.18|TWO_SIDED|95.0|-4.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-4.5|0.180
73892558|NCT02105961|147318047|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|TWO_SIDED|95.0|-2.8|2.6||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.6|-2.8|0.926
73892559|NCT02105961|147318047|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|TWO_SIDED|95.0|-2.8|2.6||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.6|-2.8|0.926
73892560|NCT02105961|147318048|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.926|TWO_SIDED|95.0|-2.3|0.0||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.0|-2.3|0.926
73892561|NCT02105961|147318048|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.055|TWO_SIDED|95.0|-2.3|0.0||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.0|-2.3|0.055
73892562|NCT02105961|147318048|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.926|TWO_SIDED|95.0|-1.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-1.5|0.926
73892563|NCT02105961|147318048|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.547|TWO_SIDED|95.0|-1.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-1.5|0.547
73892564|NCT03860259|147318049|SUPERIORITY|||||||0.1771||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.1771
73892565|NCT03860259|147318049|SUPERIORITY|||||||0.2833||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.2833
73797823|NCT02731638|147142700|SUPERIORITY||Coefficient|1.6||||0.25|TWO_SIDED|95.0|-1.2|4.4|||Regression, Linear||Positive coefficients of the logMAR value indicated worsened visual acuity|||4.4|-1.2|0.25
73797824|NCT02731638|147142700|SUPERIORITY||Coefficient|0.5||||0.75|TWO_SIDED|95.0|-2.6|3.6|||Regression, Linear||Positive coefficients of the logMAR value indicate worsened visual acuity|||3.6|-2.6|0.75
73797825|NCT01499095|147142751|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Stepwise closed testing approach was to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|95.0|-0.139|0.119||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.||0.119|-0.139|
73797826|NCT01499095|147142752|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.77||||0.038|TWO_SIDED|95.0|0.61|0.99|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (\<8.0 and \>=8.0%).||0.99|0.61|0.0380
73797827|NCT01499095|147142753|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.201||0.8279|TWO_SIDED|95.0|-0.438|0.35|||ANCOVA|||Change in pre-injection SMPG was analysed using an ANCOVA model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycaemia was significant.||0.350|-0.438|0.8279
73797828|NCT01499095|147142762|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|-0.152|0.415||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline (Month 6) HbA1c value as a covariate.||0.415|-0.152|
73797829|NCT01811472|147142787|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of -5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-1.69||||0.3128|TWO_SIDED|90.0|-4.46|1.09|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 5mg/10mg was different from placebo.||1.09|-4.46|0.3128
73797830|NCT01811472|147142787|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of -5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-2.89||||0.0457|TWO_SIDED|90.0|-5.25|-0.53|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 10mg/20mg was different from placebo.||-0.53|-5.25|0.0457
73797831|NCT01995513|147142811|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.828||||0.2176|TWO_SIDED|95.0|0.612|1.119||P-value was based on log-rank test stratified by PSA response (greater than or equal to \[\>=\] 0 percent \[%\] to less than \[\<\] 30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.119|0.612|0.2176
73797832|NCT01995513|147142812|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.874||||0.45|TWO_SIDED|95.0|0.617|1.239||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.239|0.617|0.4500
73797833|NCT01995513|147142813|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-1.65||||0.3101|TWO_SIDED|95.0|-4.82|1.51||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with \>=50% decrease from baseline in PSA response.||1.51|-4.82|0.3101
73797834|NCT01995513|147142813|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-0.04||||0.9917|TWO_SIDED|95.0|-3.9|3.82||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with \>=30% decrease from baseline in PSA response.||3.82|-3.90|0.9917
73892566|NCT03860259|147318049|SUPERIORITY|||||||0.0909||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.0909
73797835|NCT01995513|147142814|SUPERIORITY_OR_OTHER_LEGACY||Difference in Objective Response Rate|-5.0||||0.1653|TWO_SIDED|95.0|-11.75|1.75||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR.||1.75|-11.75|0.1653
73797836|NCT01995513|147142814|SUPERIORITY_OR_OTHER_LEGACY||Difference in Objective Response Rate|10.92||||0.3216|TWO_SIDED|95.0|-10.37|32.21||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR+SD.||32.21|-10.37|0.3216
73892567|NCT03860259|147318049|SUPERIORITY|||||||0.231||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.2310
73892568|NCT03860259|147318049|SUPERIORITY|||||||0.0801|||||||t-test, 1 sided|||120 hrs||||0.0801
73892569|NCT03860259|147318049|SUPERIORITY|||||||0.0307||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Total||||0.0307
73892570|NCT03860259|147318050|SUPERIORITY|||||||0.1956||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.1956
73797837|NCT01995513|147142815|SUPERIORITY_OR_OTHER_LEGACY||Difference in Progression Rate|9.09||||0.2963|TWO_SIDED|95.0|-7.69|25.87||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in Progression Rate was based upon normal approximation.|||25.87|-7.69|0.2963
73797838|NCT01995513|147142816|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.861||||0.3818|TWO_SIDED|95.0|0.616|1.204||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.204|0.616|0.3818
73797839|NCT01995513|147142823|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.399||||0.0739|TWO_SIDED|95.0|0.967|2.025||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||2.025|0.967|0.0739
73797840|NCT01232452|147142828|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.848|TWO_SIDED|95.0|0.73|1.47|||Log Rank|||||1.47|0.73|0.848
73797841|NCT01232452|147142829|SUPERIORITY|||||||0.338|||||||Fisher Exact|||||||0.338
73797842|NCT03105518|147142840|SUPERIORITY||1 way test, chisquare approximation|7.188||||0.007|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 0; Follicles ≤10 vs. \> 10||||0.007
73797843|NCT03105518|147142840|SUPERIORITY||1 way Test, ChiSquare Approximation|3.6396||||0.056|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 15; Follicles ≤10 vs. \> 10||||0.056
73797844|NCT03105518|147142840|SUPERIORITY||1 way Test, ChiSquare Approximation|15.971|||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 30; Follicles ≤10 vs. \> 10||||<0.0001
73797845|NCT03105518|147142840|SUPERIORITY||1-way Test, ChiSquare Approximation|16.0972|||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 60; Follicles ≤10 vs. \> 10||||<0.0001
73797846|NCT03105518|147142841|SUPERIORITY||1-way Test, ChiSquare Approximation|2.7205||||0.0991|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 1; Follicles ≤10 vs. \> 10||||0.0991
73797847|NCT03105518|147142841|SUPERIORITY||1 way Test, ChiSquare Approximation|1.5654||||0.2109|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 2; Follicles ≤10 vs. \> 10||||0.2109
73797848|NCT03105518|147142841|SUPERIORITY||1-way Test, ChiSquare Approximation|0.008||||0.9287|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 3; Follicles ≤10 vs. \> 10||||0.9287
73797849|NCT00247676|147142861|SUPERIORITY_OR_OTHER||clinical benefit response rate|37.8||||||95.0|22.5|55.2|||||Clinical benefit response rate: percent of patients with confirmed CR, confirmed PR, or SD for at least 12 weeks according to RECIST, relative to total treated patients.|||55.2|22.5|
73797850|NCT00247676|147142866|SUPERIORITY_OR_OTHER||objective response rate|2.7||||||95.0|0.1|14.2|||||percentage of patients with confirmed CR or confirmed PR according to RECIST, relative to the total number of treated patients.|||14.2|0.1|
73797851|NCT00247676|147142870|SUPERIORITY_OR_OTHER||probability|0.324||||||95.0|0.168|0.479|||||probability derived from Kaplan-Meier estimate.|||0.479|0.168|
73797852|NCT05024747|147142884|OTHER||Ratio T/R|96.68|||||TWO_SIDED|90.0|90.0|103.85||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||103.85|90.00|
73797853|NCT05024747|147142885|OTHER||Ratio T/R|92.37|||||TWO_SIDED|90.0|85.45|99.84||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||99.84|85.45|
73797854|NCT05024747|147142886|OTHER||Ratio T/R|92.54|||||TWO_SIDED|90.0|85.63|100.01||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||100.01|85.63|
73797855|NCT05024747|147142887|OTHER||Hodges- Lehmann's median difference|-0.0192||||0.0833|TWO_SIDED|95.0|-0.0542|0.0044|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.0044|-0.0542|0.0833
73797856|NCT05024747|147142888|OTHER||Hodges- Lehmann's median difference|-6.0||||0.0205|TWO_SIDED|95.0|-10.5|0.0|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.0000|-10.5000|0.0205
73797857|NCT05024747|147142889|OTHER||Hodges- Lehmann's median difference|0.3225||||0.0946|TWO_SIDED|95.0|-0.0949|0.681|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.6810|-0.0949|0.0946
73797858|NCT04584684|147142901|SUPERIORITY|||||||0.89||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.89
73797859|NCT04584684|147142901|SUPERIORITY|||||||0.88||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.88
73797860|NCT04584684|147142901|SUPERIORITY|||||||0.82||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.82
73797861|NCT04584684|147142901|SUPERIORITY|||||||0.65||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.65
73797862|NCT04584684|147142901|SUPERIORITY|||||||0.77||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.77
73797863|NCT04584684|147142901|SUPERIORITY|||||||0.76||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.76
73797864|NCT04584684|147142901|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.80
73797865|NCT04584684|147142901|SUPERIORITY|||||||0.71||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.71
73797866|NCT04584684|147142901|SUPERIORITY|||||||0.6||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.60
73797867|NCT04584684|147142901|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.80
73797868|NCT02955212|147142916|SUPERIORITY||Response Rate Difference|40.2|||<|0.001|TWO_SIDED|95.0|30.5|50.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||50.0|30.5|<0.001
73797869|NCT02955212|147142917|SUPERIORITY||Least Squares (LS) Mean Difference|-1.61|||<|0.001|TWO_SIDED|95.0|-1.86|-1.36|||ANCOVA|ANCOVA model including treatment as the fixed factor, and Baseline value and the stratification factor country as the covariates.|LS Mean Difference = Upadacitinib - Placebo|||-1.36|-1.86|<0.001
73797870|NCT02955212|147142918|SUPERIORITY||LS Mean Difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.55|-0.33|||ANCOVA|ANCOVA model including treatment as the fixed factor, and Baseline value and the stratification factor country as the covariates.|LS Mean Difference = Upadacitinib - Placebo|||-0.33|-0.55|<0.001
73797871|NCT02955212|147142919|SUPERIORITY||LS Mean Difference|5.57|||<|0.001|TWO_SIDED|95.0|4.13|7.01|||Mixed Effect Model Repeat Measurement|MMRM model with treatment, visit, treatment-by-visit interaction and stratification factor of country as fixed effects and Baseline value as covariate|LS Mean Difference = Upadacitinib - Placebo|||7.01|4.13|<0.001
73892571|NCT03860259|147318050|SUPERIORITY|||||||0.2274||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.2274
73797872|NCT02955212|147142920|SUPERIORITY||Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|23.4|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor country.|Response Rate Difference = Upadacitinib - Placebo|||41.7|23.4|<0.001
73797873|NCT02955212|147142921|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|24.3|16.6|31.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||31.9|16.6|<0.001
73797874|NCT02955212|147142922|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|95.0|15.6|32.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||32.9|15.6|<0.001
73797875|NCT02955212|147142923|SUPERIORITY||Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|24.0|41.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||41.0|24.0|<0.001
73797876|NCT02955212|147142924|SUPERIORITY||Response Rate Difference|17.8|||<|0.001|TWO_SIDED|95.0|11.0|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||24.5|11.0|<0.001
73797877|NCT02955212|147142925|SUPERIORITY||Response Rate Difference|19.5|||<|0.001|TWO_SIDED|95.0|12.1|27.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country|Response Rate Difference = Upadacitinib - Placebo|||27.0|12.1|<0.001
73797878|NCT02664181|147142940|SUPERIORITY|||||||0.05|||||||Fisher Exact|||Partial remission rate was compared between both arms. The null hypothesis is that there is no difference in partial remission rate between the two arms, with a p-value of \< 0.05 indicating significance||||0.05
73797879|NCT02664181|147142941|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.06|TWO_SIDED|95.0|0.13|1.21|||Log Rank|||||1.21|0.13|0.06
73892572|NCT03860259|147318050|SUPERIORITY|||||||0.109||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.1090
73892573|NCT03860259|147318050|SUPERIORITY|||||||0.1618||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.1618
73892574|NCT03860259|147318050|SUPERIORITY|||||||0.1264||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.1264
73797880|NCT02664181|147142942|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.19|TWO_SIDED|95.0|0.11|1.62|||Log Rank||Data from Kaplan-Meier analyses|||1.62|0.11|0.19
73797881|NCT02556801|147142967|SUPERIORITY||Test statistic|1.823||||0.057|ONE_SIDED||||||MCP-Mod Method|The primary dose-response analysis was performed by applying linear, Emax, logistic and exponential models.The p-value was based on Emax model.||||||0.057
73797882|NCT02556801|147142967|SUPERIORITY||Treatment effect|-1.96|STANDARD_DEVIATION|1.17|||TWO_SIDED|90.0|-3.89|-0.03||||||||-0.03|-3.89|
73797883|NCT02556801|147142967|SUPERIORITY||Treatment effect|-1.83|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.72|0.06||||||||0.06|-3.72|
73892575|NCT03860259|147318050|SUPERIORITY|||||||0.0394||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14||||0.0394
73797884|NCT02556801|147142967|SUPERIORITY||Treatment effect|-2.33|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-4.23|-0.43||||||||-0.43|-4.23|
73797885|NCT02556801|147142968|SUPERIORITY||Treatment effect|-1.92|STANDARD_ERROR_OF_MEAN|1.17|=|0.051|TWO_SIDED|90.0|-3.85|0.01|||Mixed Models Analysis|||||0.01|-3.85|=0.051
73797886|NCT02556801|147142968|SUPERIORITY||Treatment effect|-1.79|STANDARD_ERROR_OF_MEAN|1.14||0.059|TWO_SIDED|90.0|-3.68|0.1|||Mixed Models Analysis|||||0.10|-3.68|0.059
73797887|NCT02556801|147142968|SUPERIORITY||Treatment effect|-2.3|STANDARD_ERROR_OF_MEAN|1.15||0.024|TWO_SIDED|90.0|-4.2|-0.4|||Mixed Models Analysis|||||-0.40|-4.20|0.024
73797888|NCT02556801|147142969|SUPERIORITY||Treatment effect|-0.6|STANDARD_ERROR_OF_MEAN|1.08||0.291|TWO_SIDED|90.0|-2.39|1.19|||Mixed Models Analysis|||||1.19|-2.39|0.291
73797889|NCT02556801|147142969|SUPERIORITY||Treatment effect|-1.84|STANDARD_ERROR_OF_MEAN|1.06|=|0.042|TWO_SIDED|90.0|-3.6|-0.09|||Mixed Models Analysis|||||-0.09|-3.60|=0.042
73797890|NCT02556801|147142969|SUPERIORITY||Treatment effect|-1.78|STANDARD_ERROR_OF_MEAN|1.08||0.05|TWO_SIDED|90.0|-3.56|0.0|||Mixed Models Analysis|||||0.00|-3.56|0.050
73797891|NCT02556801|147142970|SUPERIORITY||Treatment effect|-0.89|STANDARD_ERROR_OF_MEAN|0.63|=|0.079|TWO_SIDED|90.0|-1.93|0.15|||Mixed Models Analysis|||||0.15|-1.93|=0.079
73797892|NCT02556801|147142970|SUPERIORITY||Treatment effect|-0.88|STANDARD_ERROR_OF_MEAN|0.61|=|0.076|TWO_SIDED|90.0|-1.89|0.13|||Mixed Models Analysis|||||0.13|-1.89|=0.076
73892576|NCT03860259|147318050|SUPERIORITY|||||||0.3968||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.3968
73892577|NCT03860259|147318050|SUPERIORITY|||||||0.3407||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60||||0.3407
73892578|NCT03860259|147318050|SUPERIORITY|||||||0.4033||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.4033
73892579|NCT03860259|147318051|SUPERIORITY|||||||0.1707||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Time of discharge||||0.1707
73892580|NCT03860259|147318051|SUPERIORITY|||||||0.3446||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.3446
73892581|NCT03860259|147318051|SUPERIORITY|||||||0.431|||||||t-test, 1 sided|||48 hrs||||0.4310
73892582|NCT03860259|147318051|SUPERIORITY|||||||0.3143||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.3143
73892583|NCT03860259|147318051|SUPERIORITY|||||||0.4749||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.4749
73892584|NCT03860259|147318051|SUPERIORITY|||||||0.3728||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.3728
73797893|NCT02556801|147142970|SUPERIORITY||Treatment effect|-1.11|STANDARD_ERROR_OF_MEAN|0.62|=|0.038|TWO_SIDED|0.62|-2.13|-0.08|||Mixed Models Analysis|||||-0.08|-2.13|=0.038
73892585|NCT03860259|147318051|SUPERIORITY|||||||0.1628|||||||t-test, 1 sided|||Day 14||||0.1628
73892586|NCT03860259|147318051|SUPERIORITY|||||||0.0731||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.0731
73892587|NCT03860259|147318051|SUPERIORITY|||||||0.4909||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60||||0.4909
73892588|NCT03860259|147318051|SUPERIORITY|||||||0.4411||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.4411
73797894|NCT02556801|147142971|SUPERIORITY||Treatment effect|-0.07|STANDARD_ERROR_OF_MEAN|0.58|=|0.451|TWO_SIDED|90.0|-1.03|0.88|||Mixed Models Analysis|||||0.88|-1.03|=0.451
73797895|NCT02556801|147142971|SUPERIORITY||Treatment effect|-0.62|STANDARD_ERROR_OF_MEAN|0.56|=|0.137|TWO_SIDED|90.0|-1.55|0.32|||Mixed Models Analysis|||||0.32|-1.55|=0.137
73892589|NCT03860259|147318052|SUPERIORITY|||||||0.1786||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Acetaminophen||||0.1786
73797896|NCT02556801|147142971|SUPERIORITY||Treatment effect|-0.5|STANDARD_ERROR_OF_MEAN|0.57|=|0.195|TWO_SIDED|90.0|-1.45|0.46|||Mixed Models Analysis|||||0.46|-1.45|=0.195
73797897|NCT02556801|147142972|SUPERIORITY||Treatment effect|-0.354|STANDARD_ERROR_OF_MEAN|0.183|=|0.028|TWO_SIDED|90.0|-0.657|-0.05|||ANOVA|||||-0.050|-0.657|=0.028
73797898|NCT02556801|147142972|SUPERIORITY||Treatment effect|-0.394|STANDARD_ERROR_OF_MEAN|0.186|=|0.018|TWO_SIDED|90.0|-0.702|-0.086|||ANOVA|||||-0.086|-0.702|=0.018
73797899|NCT02556801|147142972|SUPERIORITY||Treatment effect|-0.28|STANDARD_ERROR_OF_MEAN|0.182|=|0.063|TWO_SIDED|90.0|-0.581|0.021|||ANOVA|||||0.021|-0.581|=0.063
73797900|NCT02556801|147142973|SUPERIORITY||Treatment effect|1.92|||<|0.001|TWO_SIDED|90.0|1.41|2.6|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||2.60|1.41|<0.001
73797901|NCT02556801|147142973|SUPERIORITY||Treatment effect|2.43|||<|0.001|TWO_SIDED|90.0|1.8|3.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||3.27|1.80|<0.001
73797902|NCT02556801|147142973|SUPERIORITY||Treatment effect|2.34|||<|0.001|TWO_SIDED|90.0|1.73|3.15|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||3.15|1.73|<0.001
73797903|NCT02556801|147142973|SUPERIORITY||Treatment effect|1.42||||0.029|TWO_SIDED|90.0|1.05|1.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||1.93|1.05|0.029
73797904|NCT02556801|147142973|SUPERIORITY||Treatment effect|1.67||||0.003|TWO_SIDED|90.0|1.24|2.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||2.25|1.24|0.003
73797905|NCT02556801|147142973|SUPERIORITY||Treatment effect|1.37||||0.042|TWO_SIDED|90.0|1.01|1.85|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||1.85|1.01|0.042
73797906|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.11||||0.057|TWO_SIDED|90.0|1.0|1.23|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.23|1.00|0.057
73797907|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.29|||<|0.001|TWO_SIDED|90.0|1.17|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.43|1.17|<0.001
73797908|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.24|||<|0.001|TWO_SIDED|90.0|1.12|1.37|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.37|1.12|<0.001
73797909|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.23||||0.015|TWO_SIDED|90.0|1.05|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.45|1.05|0.015
73892590|NCT03860259|147318052|SUPERIORITY|||||||0.1876||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Ibuprofen||||0.1876
73797910|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.6|||<|0.001|TWO_SIDED|90.0|1.37|1.87|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.87|1.37|<0.001
73797911|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.39|||<|0.001|TWO_SIDED|90.0|1.19|1.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.62|1.19|<0.001
73797912|NCT02556801|147142974|SUPERIORITY||Treatment effect|0.99||||0.341|TWO_SIDED|90.0|0.93|1.04|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.04|0.93|0.341
73797913|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.1||||0.003|TWO_SIDED|90.0|1.04|1.16|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.16|1.04|0.003
73892591|NCT03860259|147318053|SUPERIORITY|||||||0.3638||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Baseline PCS||||0.3638
73892592|NCT03860259|147318053|SUPERIORITY|||||||0.0856||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14 PCS||||0.0856
73892593|NCT03860259|147318053|SUPERIORITY|||||||0.4428||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30 PCS||||0.4428
73892594|NCT03860259|147318053|SUPERIORITY|||||||0.3378||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60 PCS||||0.3378
73892595|NCT03860259|147318053|SUPERIORITY|||||||0.3942||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90 PCS||||0.3942
73892596|NCT03860259|147318053|SUPERIORITY|||||||0.219||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Baseline MCS||||0.2190
73892597|NCT03860259|147318053|SUPERIORITY|||||||0.1112||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14 MCS||||0.1112
73892598|NCT03860259|147318053|SUPERIORITY|||||||0.1737||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30 MCS||||0.1737
73892599|NCT03860259|147318053|SUPERIORITY|||||||0.2408||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60 MCS||||0.2408
73892600|NCT03860259|147318053|SUPERIORITY|||||||0.038||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90 MCS||||0.0380
73892601|NCT03860259|147318054|SUPERIORITY|||||||0.222||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||||||0.2220
73892602|NCT03860259|147318055|SUPERIORITY|||||||0.2856||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||||||0.2856
73892603|NCT03860259|147318058|SUPERIORITY|||||||0.2241|||||||t-test, 1 sided|||||||0.2241
73892604|NCT03860259|147318059|SUPERIORITY|||||||0.2714||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Time of discharge||||0.2714
73892605|NCT03860259|147318059|SUPERIORITY|||||||0.3749||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.3749
73892606|NCT03860259|147318059|SUPERIORITY|||||||0.3862||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.3862
73892607|NCT03860259|147318059|SUPERIORITY|||||||0.1735||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.1735
73892608|NCT03860259|147318059|SUPERIORITY|||||||0.4304||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.4304
73892609|NCT03860259|147318059|SUPERIORITY|||||||0.4902||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.4902
73892610|NCT03860259|147318059|SUPERIORITY|||||||0.4371||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14||||0.4371
73797914|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.02||||0.269|TWO_SIDED|90.0|0.97|1.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.08|0.97|0.269
73797915|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.02||||0.312|TWO_SIDED|90.0|0.95|1.1|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.10|0.95|0.312
73797916|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.22|||<|0.001|TWO_SIDED|90.0|1.13|1.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.31|1.13|<0.001
73797917|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.11||||0.008|TWO_SIDED|90.0|1.03|1.2|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.20|1.03|0.008
73797918|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.04||||0.212|TWO_SIDED|90.0|0.96|1.14|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.14|0.96|0.212
73797919|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.16||||0.002|TWO_SIDED|90.0|1.07|1.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.27|1.07|0.002
73797920|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.15||||0.004|TWO_SIDED|90.0|1.06|1.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.25|1.06|0.004
73797921|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.09||||0.126|TWO_SIDED|90.0|0.96|1.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.24|0.96|0.126
73797922|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.28|||<|0.001|TWO_SIDED|90.0|1.13|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.45|1.13|<0.001
73797923|NCT02556801|147142974|SUPERIORITY||Treatment effect|1.26||||0.002|TWO_SIDED|90.0|1.11|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.43|1.11|0.002
73797924|NCT02556801|147142975|SUPERIORITY||Treatment effect|1.33||||0.032|TWO_SIDED|90.0|1.03|1.7|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||1.70|1.03|0.032
73797925|NCT02556801|147142975|SUPERIORITY||Treatment effect|2.15|||<|0.001|TWO_SIDED|90.0|1.68|2.74|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||2.74|1.68|<0.001
73797926|NCT02556801|147142975|SUPERIORITY||Treatment effect|2.03|||<|0.001|TWO_SIDED|90.0|1.59|2.59|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||2.59|1.59|<0.001
73797927|NCT02556801|147142975|SUPERIORITY||Treatment effect|1.48||||0.024|TWO_SIDED|90.0|1.07|2.06|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||2.06|1.07|0.024
73892611|NCT03860259|147318059|SUPERIORITY|||||||0.195||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.1950
73892612|NCT03860259|147318059|SUPERIORITY|||||||0.4124|||||||t-test, 1 sided|||Day 60||||0.4124
73892613|NCT03860259|147318059|SUPERIORITY|||||||0.0268||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.0268
73892614|NCT04380519|147318080|SUPERIORITY||Risk Ratio (RR)|1.012||||0.434|ONE_SIDED|97.5|0.88|||Hochberg adjustment was applied for p-values|Maximal Likelihood Estimator (MLE) model||||||0.880|0.434
73892615|NCT04380519|147318080|SUPERIORITY||Risk Ratio (RR)|1.125||||0.073|ONE_SIDED|97.5|0.989|||Hochberg adjustment was applied for p-values|Maximal Likelihood Estimator (MLE) model||||||0.989|0.073
73892616|NCT04380519|147318082|SUPERIORITY||Risk Ratio (RR)|1.019||||0.393|ONE_SIDED|97.5|0.892|||unadjusted|Maximal Likelihood Estimator (MLE) model||||||0.892|0.393
73892617|NCT04380519|147318082|SUPERIORITY||Risk Ratio (RR)|1.098||||0.061|ONE_SIDED|97.5|0.975|||unadjusted|Maximal Likelihood Estimator (MLE) model||||||0.975|0.061
73892618|NCT04380519|147318083|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.31|1.44||||||||1.44|0.31|
73892619|NCT04380519|147318083|SUPERIORITY||Risk Ratio (RR)|0.33|||||TWO_SIDED|95.0|0.12|0.89||||||||0.89|0.12|
73892620|NCT04380519|147318083|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.28|1.49||||||||1.49|0.28|
73892621|NCT04380519|147318083|SUPERIORITY||Odds Ratio (OR)|0.31|||||TWO_SIDED|95.0|0.11|0.87||||||||0.87|0.11|
73892622|NCT04380519|147318084|SUPERIORITY||Risk Ratio (RR)|2.35|||||TWO_SIDED|95.0|0.93|5.92||||||||5.92|0.93|
73892623|NCT04380519|147318084|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.55|4.09||||||||4.09|0.55|
73892624|NCT04380519|147318084|SUPERIORITY||Odds Ratio (OR)|2.53|||||TWO_SIDED|95.0|0.94|6.81||||||||6.81|0.94|
73892625|NCT04380519|147318084|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.53|4.46||||||||4.46|0.53|
73892626|NCT05300763|147318101|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval is above 1.|Odds Ratio (OR)|2.01|||||TWO_SIDED|95.0|1.25|3.22|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.22|1.25|
73892627|NCT05300763|147318102|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided adjusted (96.25%) confidence interval is above 1.|Odds Ratio (OR)|2.0|||||TWO_SIDED|96.25|1.18|3.41|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.41|1.18|
73892628|NCT05300763|147318103|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided adjusted (97.5 %) confidence interval is above 1.|Odds Ratio (OR)|2.17|||||TWO_SIDED|97.5|1.3|3.64|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.64|1.30|
73892629|NCT05300763|147318104|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval is above 1.|Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.04|3.02|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.02|1.04|
73892630|NCT01727024|147318105|SUPERIORITY_OR_OTHER|||||||0.451|||||||Generalized Estimating Equation (GEE)|||||||0.451
73892631|NCT01485172|147318110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.864|TWO_SIDED|95.0|-3.41|4.05||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.05|-3.41|0.864
73892632|NCT01485172|147318110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.539|TWO_SIDED|95.0|-3.61|1.9||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.90|-3.61|0.539
73797928|NCT02556801|147142975|SUPERIORITY||Treatment effect|2.88|||<|0.001|TWO_SIDED|90.0|2.09|3.98|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||3.98|2.09|<0.001
73797929|NCT02556801|147142975|SUPERIORITY||Treatment effect|2.12|||<|0.001|TWO_SIDED|90.0|1.54|2.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||2.93|1.54|<0.001
73797930|NCT02556801|147142975|SUPERIORITY||Treatment effect|1.18||||0.102|TWO_SIDED|90.0|0.95|1.47|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||1.47|0.95|0.102
73892633|NCT01485172|147318110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.091|TWO_SIDED|95.0|-5.21|0.39||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.39|-5.21|0.091
73892634|NCT01485172|147318110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16||||0.124|TWO_SIDED|95.0|-4.93|0.6||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.60|-4.93|0.124
73797931|NCT02556801|147142975|SUPERIORITY||Treatment effect|1.99|||<|0.001|TWO_SIDED|90.0|1.61|2.46|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||2.46|1.61|<0.001
73892635|NCT01485172|147318110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.658|TWO_SIDED|95.0|-5.04|3.19||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||3.19|-5.04|0.658
73797932|NCT02556801|147142975|SUPERIORITY||Treatment effect|1.57|||<|0.001|TWO_SIDED|90.0|1.27|1.94|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||1.94|1.27|<0.001
73797933|NCT02556801|147142975|SUPERIORITY||Treatment effect|1.39||||0.019|TWO_SIDED|90.0|1.07|1.81|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||1.81|1.07|0.019
73797934|NCT02556801|147142975|SUPERIORITY||Treatment effect|2.38|||<|0.001|TWO_SIDED|90.0|1.84|3.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||3.08|1.84|<0.001
73797935|NCT02556801|147142975|SUPERIORITY||Treatment effect|1.7|||<|0.001|TWO_SIDED|90.0|1.31|2.19|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||2.19|1.31|<0.001
73892636|NCT01485172|147318110|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.439
73797936|NCT02556801|147142975|SUPERIORITY||Treatment effect|1.52||||0.048|TWO_SIDED|90.0|1.01|2.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||2.31|1.01|0.048
73797937|NCT02556801|147142975|SUPERIORITY||Treatment effect|2.35|||<|0.001|TWO_SIDED|90.0|1.56|3.53|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||3.53|1.56|<0.001
73797938|NCT02556801|147142975|SUPERIORITY||Treatment effect|2.83|||<|0.001|TWO_SIDED|90.0|1.88|4.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||4.24|1.88|<0.001
73797939|NCT02556801|147142975|SUPERIORITY||Treatment effect|1.67||||0.04|TWO_SIDED|90.0|1.03|2.69|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||2.69|1.03|0.040
73797940|NCT02556801|147142975|SUPERIORITY||Treatment effect|2.68|||<|0.001|TWO_SIDED|90.0|1.67|4.3|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||4.30|1.67|<0.001
73892637|NCT01485172|147318110|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.177
73892638|NCT01485172|147318110|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.060
73892639|NCT01485172|147318110|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.047
73892640|NCT01485172|147318110|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.407
73892641|NCT01485172|147318111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.003||||0.397|TWO_SIDED|95.0|0.4|9.98|||Generalized Estimating Equations model|||||9.98|0.40|0.397
73892642|NCT01485172|147318111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.242||||0.131|TWO_SIDED|95.0|0.79|6.4|||Generalized Estimating Equations model|||||6.40|0.79|0.131
73892643|NCT01485172|147318111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.515||||0.018|TWO_SIDED|95.0|1.25|9.92|||Generalized Estimating Equations model|||||9.92|1.25|0.018
73892644|NCT01485172|147318111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.607||||0.02||95.0|1.22|10.64|||Generalized Estimating Equations model|||||10.64|1.22|0.020
73892645|NCT01485172|147318111|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.679||||0.202|TWO_SIDED|95.0|0.59|12.16|||Generalized Estimating Equations model|||||12.16|0.59|0.202
73892646|NCT01485172|147318112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.544||||0.662||95.0|0.22|10.84|||Generalized Estimating Equations model|||||10.84|0.22|0.662
73892647|NCT01485172|147318112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.485||||0.557|TWO_SIDED|95.0|0.4|5.55|||Generalized Estimating Equations model|||||5.55|0.40|0.557
73892648|NCT01485172|147318112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.855||||0.347|TWO_SIDED|95.0|0.51|6.72|||Generalized Estimating Equations model|||||6.72|0.51|0.347
73797941|NCT02556801|147142975|SUPERIORITY||Treatment effect|2.88|||<|0.001|TWO_SIDED|90.0|1.8|4.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||4.62|1.80|<0.001
73797942|NCT02064296|147142993|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||Salience co-activation pattern at rest vs. with pressure pain.||||0.3330
73797943|NCT02064296|147142993|SUPERIORITY|||||||0.6474|||||||t-test, 2 sided|||This statistical analysis covers the sensorimotor co-activation pattern at rest vs. with pressure pain for Healthy controls||||0.6474
73797944|NCT02064296|147142993|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Salience co-activation pattern at rest vs. with pressure pain||||<0.0001
73797945|NCT02064296|147142993|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||This statistical analysis covers the sensorimotor co-activation pattern at rest vs. with pressure pain for Fibromyalgia patients||||0.0004
73797946|NCT02064296|147142994|SUPERIORITY|||||||0.0653|||||||t-test, 2 sided|||This is a comparison of Mock Laser Acupuncture pre-and post 4 weeks of treatment.||||0.0653
73797947|NCT02064296|147142994|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||This is a P value for the change in Traditional Acupuncture, pre and post 4 weeks of treatment.||||<0.0001
73797948|NCT02064296|147142995|SUPERIORITY|||||||0.7399|||||||t-test, 2 sided|||Glx statistical comparison||||0.7399
73797949|NCT02064296|147142995|SUPERIORITY|||||||0.6226|||||||t-test, 2 sided|||Glx statistical comparison||||0.6226
73797950|NCT02064296|147142996|SUPERIORITY|||||||0.6344|||||||t-test, 2 sided|||GABA statistical comparison||||0.6344
73797951|NCT02064296|147142996|SUPERIORITY|||||||0.7985|||||||t-test, 2 sided|||GABA statistical comparison||||0.7985
73797952|NCT04604795|147143115|OTHER||Ratio of geometric mean|1.05|||||TWO_SIDED|90.0|0.833|1.331|||||Log transformed Cmax was analyzed using a mixed model with fixed effects for regimen and period, and participants as random effect.|||1.331|0.833|
73797953|NCT04604795|147143115|OTHER||Ratio of geometric mean|6.45|||||TWO_SIDED|90.0|4.916|8.474|||||Log transformed Cmax was analyzed using a mixed model with regimen, period, and regimen by period as fixed effects and participants as random effect.|||8.474|4.916|
73797954|NCT04604795|147143124|OTHER||Ratio of geometric mean|1.53|||||TWO_SIDED|90.0|1.268|1.847|||||AUC(0-inf) was analyzed using a mixed model with fixed effects for regimen and period, and participants as random effect.|||1.847|1.268|
73797955|NCT04604795|147143124|OTHER||Ratio of geometric mean|12.51|||||TWO_SIDED|90.0|10.141|15.423|||||Log transformed AUC(0-inf) was analyzed using a mixed model with regimen, period, and regimen by period as fixed effects and participants as random effect.|||15.423|10.141|
73797956|NCT04604795|147143161|OTHER||Ratio of geometric mean|0.47|||||TWO_SIDED|90.0|0.318|0.693|||||Day 5 (High fat meal) versus (vs) Day 3 (fasted)|||0.693|0.318|
73797957|NCT04604795|147143161|OTHER||Ratio of geometric mean|0.6|||||TWO_SIDED|90.0|0.405|0.882|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.882|0.405|
73797958|NCT04604795|147143161|OTHER||Ratio of geometric mean|0.29|||||TWO_SIDED|90.0|0.194|0.427|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.427|0.194|
73797959|NCT04604795|147143161|OTHER||Ratio of geometric mean|0.43|||||TWO_SIDED|90.0|0.292|0.643|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.643|0.292|
73797960|NCT04604795|147143161|OTHER||Ratio of geometric mean|0.42|||||TWO_SIDED|90.0|0.28|0.617|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.617|0.280|
73797961|NCT04604795|147143161|OTHER||Ratio of geometric mean|0.61|||||TWO_SIDED|90.0|0.41|0.903|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.903|0.410|
73797962|NCT04604795|147143163|OTHER||Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.867|1.205|||||Day 5 (High fat meal) vs Day 3 (fasted)|||1.205|0.867|
73797963|NCT04604795|147143163|OTHER||Ratio of geometric mean|1.11|||||TWO_SIDED|90.0|0.941|1.308|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.308|0.941|
73797964|NCT04604795|147143163|OTHER||Ratio of geometric mean|0.79|||||TWO_SIDED|90.0|0.671|0.933|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.933|0.671|
73797965|NCT04604795|147143163|OTHER||Ratio of geometric mean|0.85|||||TWO_SIDED|90.0|0.724|1.007|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.007|0.724|
73797966|NCT04604795|147143163|OTHER||Ratio of geometric mean|0.84|||||TWO_SIDED|90.0|0.713|0.992|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.992|0.713|
73797967|NCT04604795|147143163|OTHER||Ratio of geometric mean|0.99|||||TWO_SIDED|90.0|0.837|1.165|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.165|0.837|
73797968|NCT00719186|147143181|SUPERIORITY_OR_OTHER|||||||0.007|||||||Chi-squared|||||||0.007
73797969|NCT02096744|147143233|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.33|STANDARD_ERROR_OF_MEAN|19.0|<|0.0001|TWO_SIDED|90.0|95.74|109.37|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||109.37|95.74|<0.0001
73797970|NCT02096744|147143234|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.25|STANDARD_ERROR_OF_MEAN|16.6|<|0.0001|TWO_SIDED|90.0|98.367|110.487|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||110.487|98.367|<0.0001
73797971|NCT02096744|147143235|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.78|STANDARD_ERROR_OF_MEAN|15.8|<|0.0001|TWO_SIDED|90.0|97.25|108.63|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||108.63|97.25|<0.0001
73892649|NCT01485172|147318112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.776||||0.379|TWO_SIDED|95.0|0.49|6.38|||Generalized Estimating Equations model|||||6.38|0.49|0.379
73892650|NCT01485172|147318112|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.194||||0.851|TWO_SIDED|95.0|0.19|7.63|||Generalized Estimating Equations model|||||7.63|0.19|0.851
73797972|NCT02096744|147143236|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.04|STANDARD_ERROR_OF_MEAN|16.7|<|0.0001|TWO_SIDED|90.0|98.148|110.294|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group','sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||110.294|98.148|<0.0001
73797973|NCT02517463|147143256|NON_INFERIORITY_OR_EQUIVALENCE|"The PPP from a previous study was 67.2%. Assuming the PPP in the preovulatory and post-ovulatory groups were equivalent, and taking 10% to be the maximum permitted difference for equivalence, a minimum of 273 subjects in each group would be required to confirm equivalence between the two groups with a power of 80% and type I error of 0.05. Therefore, our recruitment of 700 subjects with more than 300 in each group was sufficient."|||||<|0.0001|||||||Chi-squared|||||||<0.0001
73797974|NCT02517463|147143257|SUPERIORITY_OR_OTHER|||||||0.564|TWO_SIDED||||||Fisher Exact|||||||0.564
73797975|NCT02517463|147143258|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73797976|NCT03048552|147143260|SUPERIORITY|||||||0.148|||||||Fisher Exact|||||||0.148
73797977|NCT03048552|147143261|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
73797978|NCT03048552|147143262|SUPERIORITY|||||||0.818|||||||Fisher Exact|||||||0.818
73797979|NCT03048552|147143264|SUPERIORITY|||||||0.625|||||||Fisher Exact|||||||0.625
73797980|NCT03172494|147143265|NON_INFERIORITY|Non-inferiority of insulin degludec/liraglutide versus insulin degludec was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 0.4%. Non-inferiority was investigated on the FAS.|Mean treatment difference|-0.59|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.46|||ANCOVA|||The change from baseline in HbA1c after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) model with treatment and previous oral anti-diabetic (OAD) treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by last observation carried forward (LOCF).||-0.46|-0.73|<0.0001
73797981|NCT03172494|147143265|SUPERIORITY||Mean treatment difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.49|||ANCOVA|||The change from baseline in HbA1c after 26 weeks of treatment was analysed using an ANCOVA model with treatment and previous OAD treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by LOCF.||-0.49|-0.76|<0.0001
73797982|NCT00852202|147143356|SUPERIORITY|||||||0.7408|||||||ANCOVA|||||||0.7408
73797983|NCT00852202|147143356|SUPERIORITY|||||||0.9961|||||||ANCOVA|||||||0.9961
73797984|NCT00852202|147143357|SUPERIORITY|||||||0.3441|||||||ANCOVA|||||||0.3441
73797985|NCT00852202|147143357|SUPERIORITY|||||||0.2683|||||||ANCOVA|||||||0.2683
73797986|NCT02972892|147143358|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.|Mean Difference (Net)|10.9|||<|0.001|TWO_SIDED|95.0|6.89|15.01|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.||15.01|6.89|<.001
73797987|NCT02972892|147143359|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.|Mean Difference (Net)|52.1|||<|0.001|TWO_SIDED|95.0|46.25|57.95|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.||57.95|46.25|<.001
73797988|NCT02972892|147143360|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.|Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|2.64|8.04|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.||8.04|2.64|<.001
73797989|NCT02972892|147143361|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.|Mean Difference (Net)|44.5|||<|0.001|TWO_SIDED|95.0|35.56|53.41|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.||53.41|35.56|<.001
73797990|NCT02890355|147143387|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.28|TWO_SIDED|95.0|0.85|1.78||a priori threshold for statistical significance, one sided p=0.02|Log Rank|||||1.78|0.85|0.28
73797991|NCT02890355|147143389|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.09|TWO_SIDED|95.0|0.96|2.02|||Log Rank|||||2.02|0.96|0.09
73797992|NCT02694328|147143396|SUPERIORITY||Least Squares Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|0.765||0.003|TWO_SIDED|95.0|-3.88|-0.88||P-value was adjusted using the Cui, Hung, and Wang (CHW) method to account for the unblinded interim analysis for sample size re-estimation.|ANCOVA|Missing values at Week 24 were imputed using multiple imputation.||||-0.88|-3.88|0.003
73797993|NCT02694328|147143397|SUPERIORITY||Risk Difference (RD)|-13.7||||0.003|TWO_SIDED|95.0|-22.8|-4.6||P-value was adjusted using the CHW method to account for the unblinded interim analysis for sample size re-estimation.|Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) of ALKS 3831 vs. Olanzapine|||-4.6|-22.8|0.003
73797994|NCT02694328|147143398|SUPERIORITY||Risk Difference (RD)|-15.9||||0.001|TWO_SIDED|95.0|-25.3|-6.5|||Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) ALKS 3831 vs. Olanzapine|||-6.5|-25.3|0.001
73797995|NCT00720382|147143410|SUPERIORITY_OR_OTHER|||||||0.783||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Overall baseline score||||0.783
73797996|NCT00720382|147143410|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED|95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 1||||0.971
73797997|NCT00720382|147143410|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED|95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 3||||0.206
73797998|NCT00720382|147143410|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 6||||0.111
73797999|NCT00720382|147143410|SUPERIORITY_OR_OTHER|||||||0.181||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 9||||0.181
73798000|NCT00720382|147143410|SUPERIORITY_OR_OTHER|||||||0.037|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from Baseline to Month 12/Early Term||||0.037
73798001|NCT04205812|147143417|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0042|TWO_SIDED|95.0|0.6|0.93||The p-value was based on a stratified log-rank test at an overall 1-sided 2.5% level of significance, using O'Brien and Fleming boundary to adjust for alpha spending at interim analysis.|Log Rank||A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.93|0.60|0.0042
73798002|NCT04205812|147143418|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.79|||Log Rank|The p-value was based on the stratified log-rank test for PFS.|A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.79|0.52|<0.0001
73798003|NCT04205812|147143419|SUPERIORITY|||||||0.0012||||||The p-value was calculated at the 1-sided 2.5% level from stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|||||||0.0012
73798004|NCT06473519|147143434|NON_INFERIORITY|Noninferiority of immune responses induced by MDVRSV preF compared to SDVRSV preF, assessed for RSVA\&B at 1month after vaccination. Null hypotheses(H0): RSVA(H0A)=ln(μMDV)-ln(μSDV)\<=-ln(1.5);RSVB(H0B):ln(μMDV)-ln(μSDV)\<=-ln(1.5), where ln(μMDV)\&ln(μSDV) are means of natural log-transformed antibody concentrations 1month after vaccination for MDV and SDV groups, respectively. Noninferiority=if lower bounds of 2-sided95%CI for GMT ratios (MDV/SDV) were \>0.67(noninferiority margin=1.5)for RSVA\&B.|Geometric mean ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||GMR was calculated as group mean difference of logarithmically transformed antibody levels, back transformed to original units.|RSV A||1.10|0.84|
73798005|NCT06473519|147143434|NON_INFERIORITY|Noninferiority of immune responses induced by MDVRSV preF compared to SDVRSV preF, assessed for RSVA\&B at 1 month after vaccination. Null hypotheses(H0):RSVA(H0A)=ln(μMDV)-ln(μSDV)\<=-ln(1.5);RSVB(H0B):ln(μMDV)-ln(μSDV)\<=-ln(1.5), where ln(μMDV)\&ln(μSDV) are means of natural log-transformed antibody concentrations 1 month after vaccination for MDV and SDV groups, respectively. Noninferiority=if lower bounds of 2-sided 95%CI for GMT ratios(MDV/SDV) were \>0.67(noninferiority margin=1.5)for RSVA\&B.|Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.79|1.06|||||GMR was calculated as group mean difference of logarithmically transformed antibody levels, back transformed to original units.|RSV B||1.06|0.79|
73798006|NCT02514447|147143447|SUPERIORITY||||||<|0.0001||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (primary and key secondary myelosuppression efficacy endpoints) in a strong sense at a 1-sided 0.10 level.|non-parametric ANCOVA|Hochberg-based gatekeeping procedure||Analysis was for Part 2 data: Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and sensitivity to first line treatment (sensitive or resistant) and treatment as fixed effects.||||<0.0001
73798007|NCT02514447|147143448|SUPERIORITY|||||||0.016||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (primary and key secondary myelosuppression efficacy endpoints) in a strong sense at a 1-sided 0.10 level.|Modified Poisson|Hochberg-based gatekeeping procedure||The occurrence of SN was a binary variable. Treatment group difference was analyzed using modified Poisson regression to account for the variable duration of the Treatment Period for each patient. The model included baseline ANC as a covariate, stratification factors of ECOG performance status (0 or 1 vs 2), sensitivity to 1st line treatment (sensitive or resistant), and treatment as fixed effects. The logarithm transformation of # of cycles was included as an offset variable in the modeling.||||0.0160
73798008|NCT03860974|147143491|NON_INFERIORITY|"We tested the non-inferiority of serratus block compared with PVB using the 95% CI associated with the Wilcoxon-Mann-Whitney test with continuity correction. If the lower limit of the 95% CI for median average PACU pain scores was greater than -1.25 , we would conclude non-inferiority. The non-inferiority of serratus blocks with regard to opioid consumption was similarly tested to a predefined non-inferiority margin of 2 mg intravenous morphine equivalents."|Median Difference (Final Values)|4.0||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
73798009|NCT01750190|147143538|SUPERIORITY||Least Square Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|1.735|1.967|||ANCOVA|MI (Multiple Imputation) ANCOVA|Roxadustat - Placebo Treatment Difference|Treatment comparison was made using the multiple imputation strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb and baseline estimated glomerular filtration rate (eGFR) as covariates and treatment and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 milliliters \[mL\]/minutes \[min\]/1.73 meters \[m\]\^2), as fixed effects.||1.967|1.735|<0.0001
73798010|NCT01750190|147143539|SUPERIORITY||Odds Ratio (OR)|77.56|||<|0.0001|TWO_SIDED|95.0|44.73|134.48|||Cochran-Mantel-Haenszel||Roxadustat/Placebo Odds ratio|||134.48|44.73|<0.0001
73892651|NCT01485172|147318114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.591||||0.54|TWO_SIDED|95.0|0.36|7.03|||Generalized Estimating Equations model|||||7.03|0.36|0.540
73892652|NCT01485172|147318114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.473||||0.494|TWO_SIDED|95.0|0.49|4.47|||Generalized Estimating Equations model|||||4.47|0.49|0.494
73798011|NCT01750190|147143540|SUPERIORITY||Least Square Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|1.73|2.037|||Mixed Models Analysis|MMRM Analysis|Roxadustat - placebo treatment difference|Treatment comparison was made using MMRM with baseline Hb and baseline eGFR as covariates, and treatment, visit, visit-by-treatment interaction, and the randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73m\^2), as fixed effects.||2.037|1.730|<0.0001
73798012|NCT01750190|147143541|SUPERIORITY||Least Square Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|1.663|2.143|||ANCOVA|MI ANCOVA|Roxadustat - placebo treatment difference|Treatment comparison was made using the multiple imputation strategy by combining the results of ANCOVA model with baseline Hb and baseline eGFR as covariates , and treatment and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73m\^2 ), as fixed effects.||2.143|1.663|<0.0001
73798013|NCT01750190|147143542|SUPERIORITY||Odds Ratio (OR)|15.47|||<|0.0001|TWO_SIDED|95.0|10.79|22.189|||Cochran-Mantel-Haenszel||Roxadustat/placebo odds ratio|||22.189|10.79|<0.0001
73798014|NCT01750190|147143543|SUPERIORITY||Least Square Mean Difference|-17.26|STANDARD_ERROR_OF_MEAN|1.73|<|0.0001|TWO_SIDED|95.0|-20.65|-13.87|||Mixed Models Analysis|MMRM Analysis|Roxadustat- placebo treatment difference|Treatment comparison was made using MMRM with baseline LDL cholesterol as a covariate, and treatment, visit, visit-by-treatment interaction, and the randomization stratification factors as fixed effects.||-13.87|-20.65|<0.0001
73798015|NCT01750190|147143544|SUPERIORITY||Least Square Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.528||0.6924|TWO_SIDED|95.0|-0.827|1.245|||ANCOVA|MI ANCOVA|Roxadustat - placebo treatment difference|||1.245|-0.827|0.6924
73798016|NCT01750190|147143545|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.165|0.406||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73 m\^2).|Cox Proportional hazards model|||||0.406|0.165|<0.0001
73798017|NCT01750190|147143546|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.108|0.267||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and the randomization stratification factors, except baseline Hb (\<=8 g/dL versus \>8 g/dL) and eGFR (\<30 versus \>=30 mL/min/1.73m\^2).|Cox Proportional hazards model|||First 24 Weeks of Treatment||0.267|0.108|<0.0001
73798018|NCT01750190|147143546|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.138|0.276||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73 m\^2).|Cox Proportional hazards model|||First 52 Weeks of Treatment||0.276|0.138|<0.0001
73798019|NCT05387889|147143550|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.054|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.054
73798020|NCT05387889|147143551|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.25|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.25
73798021|NCT05387889|147143552|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.07|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.07
73798022|NCT04194645|147143617|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|97.71|||||TWO_SIDED|90.0|91.45|104.4|||ANOVA||Intra- individual coefficient of variation (gCV %) = 8.9|No formal hypothesis was tested.||104.40|91.45|
73798023|NCT04194645|147143617|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|112.88|||||TWO_SIDED|90.0|98.82|128.94|||ANOVA||Intra- individual coefficient of variation (gCV %) = 16.8|No formal hypothesis was tested.||128.94|98.82|
73798024|NCT04194645|147143618|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|48.02|||||TWO_SIDED|90.0|41.86|55.09|||ANOVA||Intra- individual coefficient of variation (gCV %) = 18.5|No formal hypothesis was tested.||55.09|41.86|
73798025|NCT04194645|147143618|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|122.8|||||TWO_SIDED|90.0|105.04|143.56|||ANOVA||Intra- individual coefficient of variation (gCV %) = 19.8|No formal hypothesis was tested.||143.56|105.04|
73798026|NCT04194645|147143621|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|98.32|||||TWO_SIDED|90.0|91.98|105.09|||ANOVA||Intra- individual coefficient of variation (gCV %) = 8.9|No formal hypothesis was tested.||105.09|91.98|
73798027|NCT04194645|147143621|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|112.94|||||TWO_SIDED|90.0|98.75|129.18|||ANOVA||Intra- individual coefficient of variation (gCV %) = 16.9|No formal hypothesis was tested.||129.18|98.75|
73798028|NCT03076775|147143622|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
73892653|NCT01485172|147318114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.391||||0.115|TWO_SIDED|95.0|0.81|7.06|||Generalized Estimating Equations model|||||7.06|0.81|0.115
73892654|NCT01485172|147318114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96||||0.045|TWO_SIDED|95.0|1.02|8.55|||Generalized Estimating Equations model|||||8.55|1.02|0.045
73892655|NCT01485172|147318114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.506||||0.221|TWO_SIDED|95.0|0.58|10.9|||Generalized Estimating Equations model|||||10.90|0.58|0.221
73892656|NCT01485172|147318115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.662|TWO_SIDED|95.0|-3.78|5.93||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||5.93|-3.78|0.662
73892657|NCT01485172|147318115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.621|TWO_SIDED|95.0|-4.63|2.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.77|-4.63|0.621
73892658|NCT01485172|147318115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.75||||0.15|TWO_SIDED|95.0|-6.5|1.01||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.01|-6.50|0.150
73892659|NCT01485172|147318115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74||||0.048|TWO_SIDED|95.0|-7.43|-0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||-0.04|-7.43|0.048
73892660|NCT01485172|147318115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.715|TWO_SIDED|95.0|-6.32|4.35||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.35|-6.32|0.715
73892661|NCT01485172|147318116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17||||0.158|TWO_SIDED|95.0|-0.46|2.81||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.81|-0.46|0.158
73892662|NCT01485172|147318116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.446|TWO_SIDED|95.0|-1.71|0.76||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.76|-1.71|0.446
73892663|NCT01485172|147318116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.163|TWO_SIDED|95.0|-2.1|0.36||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.36|-2.10|0.163
73798029|NCT03076775|147143623|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
73798030|NCT03076775|147143624|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
73798031|NCT03076775|147143625|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
73892664|NCT01485172|147318116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.117|TWO_SIDED|95.0|-2.27|0.25||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.25|-2.27|0.117
73892665|NCT01485172|147318116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.456|TWO_SIDED|95.0|-2.67|1.2||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.20|-2.67|0.456
73892666|NCT01485172|147318117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.823|TWO_SIDED|95.0|-4.38|5.5||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||5.50|-4.38|0.823
73892667|NCT01485172|147318117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.568|TWO_SIDED|95.0|-4.86|2.68||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.68|-4.86|0.568
73892668|NCT01485172|147318117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.19||||0.101|TWO_SIDED|95.0|-7.01|0.63||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.63|-7.01|0.101
73892669|NCT01485172|147318117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94||||0.04|TWO_SIDED|95.0|-7.7|-0.18||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||-0.18|-7.70|0.040
73892670|NCT01485172|147318117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.811|TWO_SIDED|95.0|-6.08|4.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.77|-6.08|0.811
73892671|NCT01485172|147318118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.102|TWO_SIDED|95.0|-0.86|0.08||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.08|-0.86|0.102
73892672|NCT01485172|147318118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.723|TWO_SIDED|95.0|-0.41|0.29||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.29|-0.41|0.723
73892673|NCT01485172|147318118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.084|TWO_SIDED|95.0|-0.66|0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.04|-0.66|0.084
73892674|NCT01485172|147318118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.697|TWO_SIDED|95.0|-0.42|0.28||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.28|-0.42|0.697
73892675|NCT01485172|147318118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.086|TWO_SIDED|95.0|-0.06|0.97||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.97|-0.06|0.086
73892676|NCT01485172|147318119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.769||||0.733|TWO_SIDED|95.0|0.17|3.49|||Generalized Estimating Equations model|||||3.49|0.17|0.733
73798032|NCT03076775|147143626|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
73798033|NCT03076775|147143627|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
73798034|NCT03076775|147143628|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
73798035|NCT03076775|147143629|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
73798036|NCT03076775|147143630|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
73798037|NCT03076775|147143631|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
73798038|NCT01783886|147143637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.1|||<|0.0001|TWO_SIDED|97.5|10.9|17.2|||ANCOVA||Least Square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||17.2|10.9|<0.0001
73798039|NCT01783886|147143637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||<|0.0001|TWO_SIDED|97.5|10.2|16.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||16.9|10.2|<0.0001
73798040|NCT01783886|147143638|SUPERIORITY_OR_OTHER||CMH adjusted difference|47.4|||<|0.0001|TWO_SIDED|97.5|35.0|59.9|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH). The estimate is calculated as EYLEA minus Laser.|||59.9|35.0|<0.0001
73892677|NCT01485172|147318119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.411||||0.519|TWO_SIDED|95.0|0.5|4.02|||Generalized Estimating Equations model|||||4.02|0.50|0.519
73892678|NCT01485172|147318119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.204||||0.008|TWO_SIDED|95.0|1.46|12.07|||Generalized Estimating Equations model|||||12.07|1.46|0.008
73892679|NCT01485172|147318119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.456||||0.001|TWO_SIDED|95.0|1.93|15.46|||Generalized Estimating Equations model|||||15.46|1.93|0.001
73892680|NCT01485172|147318119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.281||||0.752|TWO_SIDED|95.0|0.27|5.98|||Generalized Estimating Equations model|||||5.98|0.27|0.752
73892681|NCT02283762|147318131|SUPERIORITY||Difference of LS means|-2.34||||0.0815|TWO_SIDED|95.0|-4.99|0.3|||MMRM (Method 1)|||||0.30|-4.99|0.0815
73892682|NCT02283762|147318132|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|%|0.2||||0.977|TWO_SIDED|95.0|-13.68|14.09|||Mantel Haenszel|||||14.09|-13.68|0.9770
73892683|NCT02283762|147318133|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.07||||0.3529|TWO_SIDED|95.0|-0.23|0.08|||MMRM (Method 1)|||change from baseline||0.08|-0.23|0.3529
73892684|NCT02283762|147318134|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.79||||0.0887|TWO_SIDED|95.0|-0.12|1.69|||MMRM (Method 1)|||Change from baseline||1.69|-0.12|0.0887
73892685|NCT02283762|147318135|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.83||||0.0241|TWO_SIDED|95.0|0.11|1.54|||MMRM (Method 1)|||Change from baseline||1.54|0.11|0.0241
73892686|NCT02283762|147318136|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.2||||0.901|TWO_SIDED|95.0|-3.4|3.0|||MMRM (Method 1)|||change from baseline||3.00|-3.40|0.9010
73798041|NCT01783886|147143638|SUPERIORITY_OR_OTHER||CMH adjusted difference|39.2|||<|0.0001|TWO_SIDED|97.5|26.3|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||52.1|26.3|<0.0001
73892687|NCT00202878|147318137|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.016|TWO_SIDED|95.0|0.887|0.988|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.988|0.887|0.016
73892688|NCT00202878|147318138|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.948||||0.035|TWO_SIDED|95.0|0.903|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.996|0.903|0.035
73892689|NCT00202878|147318139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.912||||0.016|TWO_SIDED|95.0|0.847|0.983|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.983|0.847|0.016
73892690|NCT00202878|147318140|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.945||||0.035|TWO_SIDED|95.0|0.897|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment|Model includes events from randomization to last study visit.|||0.996|0.897|0.035
73892691|NCT02028208|147318150|OTHER|Concordance between 0.40 mg/cm2 mercury and 1.0% ammoniated mercury in petrolatum|Kappa statistic|0.38|||||TWO_SIDED|95.0|0.08|0.67||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.67|0.08|
73892692|NCT02028208|147318150|OTHER|Concordance between 0.40 mercury and 0.5% elemental mercury in petrolatum|Kappa statistic|0.67|||||TWO_SIDED|95.0|0.35|0.99||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.99|0.35|
73892693|NCT02028208|147318150|OTHER|Concordance between 0.36 mg/cm2 mercury and 1.0% ammoniated mercury in petrolatum|Kappa statistic|0.46|||||TWO_SIDED|95.0|0.15|0.76||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.76|0.15|
73892694|NCT02028208|147318150|OTHER|Concordance between 0.36 mg/cm2 mercury and 0.5% elemental mercury in petrolatum|Kappa statistic|0.57|||||TWO_SIDED|95.0|0.21|0.93||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.93|0.21|
73892695|NCT02028208|147318150|OTHER|Concordance between 0.10 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum|Kappa statistic|0.48|||||TWO_SIDED|95.0|0.05|0.9||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.90|0.05|
73892696|NCT02028208|147318150|OTHER|Concordance between 0.10 mg/cm2 palladium and 1.0% palladium chloride in petrolatum|Kappa statistic|0.39|||||TWO_SIDED|95.0|0.1|0.68||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.68|0.10|
73892697|NCT02028208|147318150|OTHER||Kappa statistic|0.83|||||TWO_SIDED|95.0|0.5|1.0||||||Concordance between 0.30 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum||1.00|0.50|
73892698|NCT02028208|147318150|OTHER|Concordance between 0.30 mg/cm2 palladium and 1.0% palladium chloride in petrolatum|Kappa statistic|0.19|||||TWO_SIDED|95.0|-0.02|0.39||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.39|-0.02|
73892699|NCT02028208|147318150|OTHER|Concordance between 0.60 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum|Kappa statistic|0.83|||||TWO_SIDED|95.0|0.5|1.0||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||1.00|0.50|
73798042|NCT01783886|147143639|SUPERIORITY_OR_OTHER||CMH adjusted difference|31.1|||<|0.0001|TWO_SIDED|97.5|19.2|43.0|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||43.0|19.2|<0.0001
73798043|NCT01783886|147143639|SUPERIORITY_OR_OTHER||CMH adjusted difference|24.3|||<|0.0001|TWO_SIDED|97.5|12.6|35.9|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||35.9|12.6|<0.0001
73798044|NCT01783886|147143640|SUPERIORITY_OR_OTHER||CMH adjusted difference|39.1|||<|0.0001|TWO_SIDED|97.5|26.0|52.2|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||52.2|26.0|<0.0001
73798045|NCT01783886|147143640|SUPERIORITY_OR_OTHER||CMH adjusted difference|40.6|||<|0.0001|TWO_SIDED|97.5|27.6|53.7|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||53.7|27.6|<0.0001
73798046|NCT01783886|147143641|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-130.5|||<|0.0001|TWO_SIDED|97.5|-171.2|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||-89.9|-171.2|<0.0001
73798047|NCT01783886|147143641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-131.4|||<|0.0001|TWO_SIDED|97.5|-172.8|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||-89.9|-172.8|<0.0001
73798048|NCT01783886|147143642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.78||||0.0364|TWO_SIDED|97.5|-0.41|11.97|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||11.97|-0.41|0.0364
73798049|NCT01783886|147143642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.87||||0.0113|TWO_SIDED|97.5|0.8|12.94|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||12.94|0.80|0.0113
73798050|NCT01783886|147143643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81||||0.2688|TWO_SIDED|97.5|-2.9|8.53|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||8.53|-2.90|0.2688
73798051|NCT01783886|147143643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.01||||0.0009|TWO_SIDED|97.5|2.64|13.37|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||13.37|2.64|0.0009
73798052|NCT04542057|147143644|SUPERIORITY||LS mean difference|0.0941|STANDARD_ERROR_OF_MEAN|0.01501|<|0.0001|TWO_SIDED|95.0|0.0647|0.1236||The analysis of covariance (ANCOVA) model was used to model the change from baseline FEV1 to average FEV1 AUC0-12h with treatment, region, background medication strata and smoking strata as fixed effects and baseline FEV1 as covariate.|ANCOVA|||||0.1236|0.0647|<0.0001
73798053|NCT00825786|147143732|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.14|TWO_SIDED|95.0|0.46|1.09|||Log Rank||group 2 vs. group 1 (sequential vs combined)|||1.09|0.46|0.14
73798054|NCT00825786|147143733|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.02
73892700|NCT02028208|147318150|OTHER||Kappa statistic|0.06|||||TWO_SIDED|95.0|-0.05|0.17||||Concordance between 0.60 mg/cm2 palladium and 1.0 palladium chloride in petrolatum||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.17|-0.05|
73798055|NCT00825786|147143734|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
73798056|NCT00825786|147143735|SUPERIORITY|||||||0.6|||||||ANCOVA|||||||0.60
73798057|NCT00825786|147143736|SUPERIORITY|||||||0.34|||||||ANCOVA|||||||0.34
73798058|NCT00825786|147143737|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
73798059|NCT00825786|147143738|SUPERIORITY|||||||0.88|||||||ANCOVA|||||||0.88
73798060|NCT00770328|147143739|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
73798061|NCT00770328|147143740|SUPERIORITY|||||||0.0114|||||||Wilcoxon (Mann-Whitney)|||||||0.0114
73798062|NCT03452943|147143743|OTHER||LS mean difference|-0.7||||0.692|TWO_SIDED|95.0|-4.1|2.8||Threshold for significance at 0.05 level.|Mixed Models Analysis|||||2.8|-4.1|0.692
73798063|NCT03541317|147143753|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of CBT sessions delivered to students by SPs over the four post-randomization phases during Stages 1 and 2|Difference in sum of means*|9.7||||0.63|TWO_SIDED|95.0|-30.03|49.4|||weighted least squares regression|Marginal means under each implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne, \& Almirall 2017)|\*Difference in the sum of the means estimated at each post-randomization phase.|||49.40|-30.03|0.63
73798064|NCT03541317|147143754|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of brief individual CBT sessions (\<15 min.) delivered to students by SPs over the four post-randomization phases occurring during Stages 1 and 2.|Difference in sum of means*|3.78||||0.72|TWO_SIDED|95.0|-16.88|24.44|||weighted least squares regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017)|\*Difference in the sum of the means estimated at each post-randomization phase|||24.44|-16.88|0.72
73798065|NCT03541317|147143755|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of brief individual CBT sessions (\>15 min.) delivered to students by SPs over the four post-randomization phases occurring during Stages 1 and 2.|Difference in sum of means*|7.85||||0.46|TWO_SIDED|95.0|-13.2|28.91|||Weighted Least Squares Regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017).|Difference in the sum of the means estimated at each post-randomization phase|||28.91|-13.20|0.46
73798066|NCT03541317|147143756|SUPERIORITY||Difference in sum of means*|-0.66||||0.87|TWO_SIDED|95.0|-8.49|7.16|||Weighted Least Squares Regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017).|Difference in the sum of the means estimated at each post-randomization phase|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of group CBT sessions delivered to students by SPs over the four post-randomization phase occurring during Stages 1 and 2.||7.16|-8.49|0.87
73798067|NCT02593110|147143791|SUPERIORITY||Mean Difference (Final Values)|-24.41||||0.1107|TWO_SIDED|95.0|-54.59|5.78|||ANCOVA|||||5.78|-54.59|0.1107
73798068|NCT02593110|147143791|SUPERIORITY||Mean Difference (Final Values)|9.78||||0.5378|TWO_SIDED|95.0|-21.84|41.39|||ANCOVA|||||41.39|-21.84|0.5378
73798069|NCT02593110|147143791|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.956|TWO_SIDED|95.0|-24.96|26.38|||ANCOVA|||||26.38|-24.96|0.9560
73798070|NCT02593110|147143792|SUPERIORITY||Mean Difference (Final Values)|31.35||||0.6121|TWO_SIDED|95.0|-92.42|155.12|||ANCOVA|||||155.12|-92.42|0.6121
73798071|NCT02593110|147143792|SUPERIORITY||Mean Difference (Final Values)|141.78||||0.0116|TWO_SIDED|95.0|33.14|250.42|||ANCOVA|||||250.42|33.14|0.0116
73892701|NCT03563183|147318155|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine Group compared to Placebo Group.|Vaccine Efficacy rate|95.81|||<|0.0001|TWO_SIDED|95.0|91.58|98.22|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Non-Frail-HZ/su vs Non-Frail-Placebo groups.||98.22|91.58|<0.0001
73798072|NCT02593110|147143792|SUPERIORITY||Mean Difference (Final Values)|-14.75||||0.8146|TWO_SIDED|95.0|-140.89|111.39|||ANCOVA|||||111.39|-140.89|0.8146
73798073|NCT02593110|147143793|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.8755|TWO_SIDED|95.0|-10.84|12.68|||ANCOVA|||||12.68|-10.84|0.8755
73798074|NCT02593110|147143793|SUPERIORITY||Mean Difference (Final Values)|2.44||||0.7651|TWO_SIDED|95.0|-13.83|18.7|||ANCOVA|||||18.70|-13.83|0.7651
73798075|NCT02593110|147143793|SUPERIORITY||Mean Difference (Final Values)|6.88||||0.3776|TWO_SIDED|95.0|-8.65|22.41|||ANCOVA|||||22.41|-8.65|0.3776
73798076|NCT02593110|147143794|SUPERIORITY||Mean Difference (Final Values)|-8.06||||0.1782|TWO_SIDED|95.0|-19.91|3.79|||ANCOVA|||||3.79|-19.91|0.1782
73798077|NCT02593110|147143794|SUPERIORITY||Mean Difference (Final Values)|-5.27||||0.3555|TWO_SIDED|95.0|-16.61|6.07|||ANCOVA|||||6.07|-16.61|0.3555
73798078|NCT02593110|147143794|SUPERIORITY||Mean Difference (Final Values)|5.75||||0.3294|TWO_SIDED|95.0|-5.99|17.49|||ANCOVA|||||17.49|-5.99|0.3294
73798079|NCT02593110|147143795|SUPERIORITY||Mean Difference (Final Values)|-8.72||||0.1569|TWO_SIDED|95.0|-20.91|3.47|||ANCOVA|||||3.47|-20.91|0.1569
73798080|NCT02593110|147143795|SUPERIORITY||Mean Difference (Final Values)|-2.07||||0.7692|TWO_SIDED|95.0|-16.16|12.02|||ANCOVA|||||12.02|-16.16|0.7692
73798081|NCT02593110|147143795|SUPERIORITY||Mean Difference (Final Values)|3.09||||0.6306|TWO_SIDED|95.0|-9.74|15.91|||ANCOVA|||||15.91|-9.74|0.6306
73798082|NCT02593110|147143796|SUPERIORITY||Mean Difference (Final Values)|-7.86||||0.3542|TWO_SIDED|95.0|-24.74|9.02|||ANCOVA|||||9.02|-24.74|0.3542
73798083|NCT02593110|147143796|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.9417|TWO_SIDED|95.0|-17.98|16.71|||ANCOVA|||||16.71|-17.98|0.9417
73892702|NCT03563183|147318155|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.4|||<|0.0001|TWO_SIDED|95.0|84.41|94.43|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Pre-Frail-HZ/su vs Pre-Frail-Placebo groups.||94.43|84.41|<0.0001
73798084|NCT02593110|147143796|SUPERIORITY||Mean Difference (Final Values)|5.45||||0.4508|TWO_SIDED|95.0|-8.96|19.86|||ANCOVA|||||19.86|-8.96|0.4508
73798085|NCT03086551|147143797|OTHER||Effect Size - Cohen's d|0.2|||||TWO_SIDED||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Active arm. Cohen's d was calculated as a measure of effect size.||||
73798086|NCT03086551|147143797|OTHER||Effect Size - Cohen's d|0.69|||||TWO_SIDED||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Sham arm. Cohen's d was calculated as a measure of effect size.||||
73798087|NCT03086551|147143797|OTHER|Cohen's d effect size was calculated to compare the magnitude of change in time to complete the movement sequence from pre-baseline to post-intervention across the Active and Sham arms.|Effect Size - Cohen's d|-0.8|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|||||
73798088|NCT03086551|147143798|OTHER||Effect Size - Cohen's d|-0.08|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.||||
73798089|NCT03086551|147143798|OTHER||Effect Size - Cohen's d|0.5|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.||||
73798090|NCT03086551|147143798|OTHER||Effect Size - Cohen's d|-1.84|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the stroke affected limb. Cohen's d was calculated as a measure of effect size.||||
73798091|NCT03086551|147143798|OTHER||Effect Size - Cohen's d|0.38|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.||||
73798092|NCT03086551|147143798|OTHER||Effect Size - Cohen's d|0.08|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.||||
73892703|NCT03563183|147318155|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.17|||<|0.0001|TWO_SIDED|95.0|75.36|96.65|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Frail-HZ/su vs Frail-Placebo groups.||96.65|75.36|<0.0001
73798093|NCT03086551|147143798|OTHER||Effect Size - Cohen's d|0.38|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the non-stroke affected limb. Cohen's d was calculated as a measure of effect size.||||
73798094|NCT03086551|147143799|OTHER||Effect Size - Cohen's d|-0.86|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 1 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
73798095|NCT03086551|147143799|OTHER||Effect Size - Cohen's d|-0.04|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 2 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
73798096|NCT03086551|147143799|OTHER||Effect Size - Cohen's d|-0.69|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 3 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
73798097|NCT03086551|147143799|OTHER||Effect Size - Cohen's d|0.28|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 4 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
73798098|NCT03086551|147143800|OTHER||Effect Size - Cohen's d|-0.31|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
73798099|NCT03086551|147143800|OTHER||Effect Size - Cohen's d|-0.85|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
73798100|NCT03086551|147143800|OTHER||Effect Size - Cohen's d|-0.35|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
73892704|NCT03563183|147318155|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|100.0||||0.069|TWO_SIDED|95.0|14.61|100.0|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Unknown-HZ/su vs Unknown-Placebo groups.||100|14.61|0.069
73892705|NCT03563183|147318156|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|98.6|||||TWO_SIDED|95.0|97.1|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||100|97.1|
73892706|NCT03563183|147318156|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|92.6|||||TWO_SIDED|95.0|86.6|98.7||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||98.7|86.6|
73892707|NCT03563183|147318156|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|85.2|||||TWO_SIDED|95.0|62.6|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||100|62.6|
73892708|NCT03563183|147318156|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|100.0||||||||||||||VE against the BOI due to confirmed HZ. The 95% Confidence Interval was not calculated as there were no subjects reported with a confirmed Zoster episode in the Unknown-HZ/su Group.||||
73798101|NCT03086551|147143800|OTHER||Effect Size - Cohen's d|1.13|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
73798102|NCT03086551|147143801|OTHER||Effect Size - Cohen's d|-0.15|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Comparison quantified as effect size using Cohen's d.||||
73798103|NCT03086551|147143801|OTHER||Effect Size - Cohen's d|-1.46|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Comparison quantified as effect size using Cohen's d.||||
73798104|NCT02487225|147143802|SUPERIORITY|||||||0.5796|||||||Kruskal-Wallis|||Admission (baseline)||||0.5796
73798105|NCT02487225|147143802|SUPERIORITY|||||||0.8415|||||||Kruskal-Wallis|||Day 5||||0.8415
73798106|NCT02487225|147143803|SUPERIORITY|||||||0.1109|||||||Kruskal-Wallis|||Admission (baseline)||||0.1109
73798107|NCT02487225|147143803|SUPERIORITY|||||||0.4619|||||||Kruskal-Wallis|||||||0.4619
73798108|NCT02487225|147143804|SUPERIORITY|||||||0.1236|||||||Kruskal-Wallis|||Admission (baseline)||||0.1236
73798109|NCT02487225|147143804|SUPERIORITY|||||||0.9468|||||||Kruskal-Wallis|||Day 5||||0.9468
73892709|NCT00573144|147318243|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
73892710|NCT00573144|147318244|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
73892711|NCT00573144|147318245|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||||||0.26
73798110|NCT02487225|147143805|SUPERIORITY|||||||0.157|||||||Kruskal-Wallis|||Admission (baseline)||||0.157
73798111|NCT02487225|147143805|SUPERIORITY|||||||0.3173|||||||Kruskal-Wallis|||Day 5||||0.3173
73798112|NCT00625872|147143806|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.43|STANDARD_ERROR_OF_MEAN|1.1||0.7232|TWO_SIDED|95.0|-3.93|3.08||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Analysis of covariance (ANCOVA) method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||3.08|-3.93|0.7232
73798113|NCT00625872|147143807|SUPERIORITY_OR_OTHER||LS Mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.51||0.1941|TWO_SIDED|95.0|-8.04|4.82||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||4.82|-8.04|0.1941
73798114|NCT00625872|147143809|SUPERIORITY_OR_OTHER|||||||0.0532||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Sequential Processing): Kruskal-Wallis Analysis of Variance (ANOVA) model was used to calculate p-value.||||0.0532
73798115|NCT00625872|147143809|SUPERIORITY_OR_OTHER|||||||0.3383||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Simultaneous Processing): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3383
73798116|NCT00625872|147143809|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Achievement): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.6830
73798117|NCT00625872|147143809|SUPERIORITY_OR_OTHER|||||||0.4935||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Non-Verbal): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.4935
73798118|NCT00625872|147143809|SUPERIORITY_OR_OTHER|||||||0.3458||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Mental Processing Composite): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3458
73798119|NCT00625872|147143811|SUPERIORITY_OR_OTHER|||||||0.6256||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Distractibility): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.6256
73798120|NCT00625872|147143811|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Alertness): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.8590
73892712|NCT00035932|147318257|NON_INFERIORITY_OR_EQUIVALENCE|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.14|||||TWO_SIDED|97.5|-0.09|0.37||||||||0.37|-0.09|
73892713|NCT00035932|147318257|NON_INFERIORITY_OR_EQUIVALENCE|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.31|||||TWO_SIDED|97.5|0.07|0.55||||||||0.55|0.07|
73892714|NCT00035932|147318258|SUPERIORITY_OR_OTHER||Treatment Difference|0.13|||||TWO_SIDED|95.0|-0.04|0.3||||||||0.30|-0.04|
73892715|NCT00035932|147318258|SUPERIORITY_OR_OTHER||Treatment Difference|0.17|||||TWO_SIDED|95.0|-0.01|0.35||||||||0.35|-0.01|
73892716|NCT00035932|147318261|SUPERIORITY_OR_OTHER||Time-Averaged Difference|0.13|||||TWO_SIDED|97.5|-0.12|0.39||||||||0.39|-0.12|
73892717|NCT00035932|147318261|SUPERIORITY_OR_OTHER||Time-Averaged Distance|0.33|||||TWO_SIDED|97.5|0.07|0.6||||||||0.60|0.07|
73892718|NCT00035932|147318262|SUPERIORITY_OR_OTHER||Difference estimate|-0.5|||||TWO_SIDED|95.0|-13.3|12.3|||||ATV 300/RTV - LPV/RTV|Randomized participants||12.3|-13.3|
73892719|NCT00035932|147318263|SUPERIORITY_OR_OTHER||Difference Estimate|3.6|||||TWO_SIDED|95.0|-7.0|14.1||||||||14.1|-7.0|
73892720|NCT00035932|147318263|SUPERIORITY_OR_OTHER||Difference Estimate|-11.3|||||TWO_SIDED|95.0|-22.9|0.4||||||||0.4|-22.9|
73892721|NCT00035932|147318265|SUPERIORITY_OR_OTHER||Difference Estimate|-5.0|||||TWO_SIDED|95.0|-16.9|7.0||||||||7.0|-16.9|
73892722|NCT00035932|147318265|SUPERIORITY_OR_OTHER||Difference Estimate|-16.1|||||TWO_SIDED|95.0|-28.5|-3.7||||||||-3.7|-28.5|
73892723|NCT00035932|147318267|SUPERIORITY_OR_OTHER||Difference Estimate|0.4|||||TWO_SIDED|95.0|-12.5|13.2|||||ATV 300/RTV - LPV/RTV|||13.2|-12.5|
73892724|NCT00035932|147318268|SUPERIORITY_OR_OTHER||Difference Estimate|3.2|||||TWO_SIDED|95.0|-9.1|15.4||||||||15.4|-9.1|
73892725|NCT00035932|147318268|SUPERIORITY_OR_OTHER||Difference Estimate|-16.7|||||TWO_SIDED|95.0|-29.4|-4.0||||||||-4.0|-29.4|
73892726|NCT00035932|147318269|SUPERIORITY_OR_OTHER||Difference Estimate|-1.1|||||TWO_SIDED|95.0|-13.7|11.4||||||||11.4|-13.7|
73892727|NCT00035932|147318269|SUPERIORITY_OR_OTHER||Difference Estimate|-17.9|||||TWO_SIDED|95.0|-30.6|-5.3||||||||-5.3|-30.6|
73892728|NCT00035932|147318270|SUPERIORITY_OR_OTHER||Difference Estimate|-2.4|||||TWO_SIDED|95.0|-15.0|10.3|||Chi-squared, Corrected||ATV 300/RTV - LPV/RTV|||10.3|-15.0|
73892729|NCT00035932|147318271|SUPERIORITY_OR_OTHER||Difference Estimate|-2.3|||||TWO_SIDED|95.0|-14.6|10.0||||||||10.0|-14.6|
73892730|NCT00035932|147318271|SUPERIORITY_OR_OTHER||Difference Estimate|-18.9|||||TWO_SIDED|95.0|-30.7|-7.1||||||||-7.1|-30.7|
73892731|NCT00035932|147318272|SUPERIORITY_OR_OTHER||Difference Estimate|-6.4|||||TWO_SIDED|95.0|-18.7|5.8||||||||5.8|-18.7|
73892732|NCT00035932|147318272|SUPERIORITY_OR_OTHER||Difference Estimate|-17.9|||||TWO_SIDED|95.0|-29.9|-5.9||||||||-5.9|-29.9|
73892733|NCT00035932|147318274|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-18.4|||||TWO_SIDED|97.5|-44.3|7.5||||||||7.5|-44.3|
73892734|NCT00035932|147318274|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-44.9|||||TWO_SIDED|97.5|-74.5|-15.3||||||||-15.3|-74.5|
73892735|NCT00035932|147318275|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-17.5|||||TWO_SIDED|97.5|-45.6|10.6||||||||10.6|-45.6|
73892736|NCT00035932|147318275|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-47.6|||||TWO_SIDED|97.5|-79.2|-16.1||||||||-16.1|-79.2|
73892737|NCT00035932|147318277|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (\<10; \>=10) of ATV 300 mg / RTV and HIV RNA||||<0.05
73892738|NCT00035932|147318277|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between number of PI Mutations at baseline (\<4; \>=4) of ATV 400 mg / SQV and HIV RNA||||<0.05
73892739|NCT00035932|147318279|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between ATV Cmin of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
73892740|NCT00035932|147318279|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (\<10; \>=10) of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
73892741|NCT00035932|147318279|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between # of PI Mutations at baseline (\<4; \>=4) of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
73892742|NCT00035932|147318281|SUPERIORITY_OR_OTHER||Difference Estimate|-10.9|||||TWO_SIDED|95.0|-15.5|-6.0||||||Total Cholesterol||-6.0|-15.5|
73892743|NCT00035932|147318281|SUPERIORITY_OR_OTHER||Difference Estimate|-12.4|||||TWO_SIDED|95.0|-16.9|-7.6||||||Total Cholesterol||-7.6|-16.9|
73892744|NCT00035932|147318281|SUPERIORITY_OR_OTHER||Difference Estimate|-6.7|||||TWO_SIDED|95.0|-13.6|0.7||||||HDL cholesterol||0.7|-13.6|
73892745|NCT00035932|147318281|SUPERIORITY_OR_OTHER||Difference Estimate|-1.0|||||TWO_SIDED|95.0|-9.3|8.1||||||HDL Cholesterol||8.1|-9.3|
73892746|NCT00035932|147318281|SUPERIORITY_OR_OTHER||Difference Estimate|-6.8|||||TWO_SIDED|95.0|-15.6|3.0||||||Fasting LDL Cholesterol||3.0|-15.6|
73892747|NCT00035932|147318281|SUPERIORITY_OR_OTHER||Difference Estimate|-7.3|||||TWO_SIDED|95.0|-15.5|1.8||||||Fasting LDL Cholesterol||1.8|-15.5|
73892748|NCT00035932|147318281|SUPERIORITY_OR_OTHER||Difference Estimate|-24.9|||||TWO_SIDED|95.0|-35.0|-13.2||||||Fasting Triglycerides||-13.2|-35.0|
73892749|NCT00035932|147318281|SUPERIORITY_OR_OTHER||Difference Estimate|-34.2|||||TWO_SIDED|95.0|-43.4|-23.4||||||Fasting Triglycerides||-23.4|-43.4|
73892750|NCT00035932|147318282|SUPERIORITY_OR_OTHER||Difference Estimate|-12.1|||||TWO_SIDED|95.0|-17.0|-7.2||||||Total Cholesterol||-7.2|-17.0|
73892751|NCT00035932|147318282|SUPERIORITY_OR_OTHER||Difference Estimate|-12.0|||||TWO_SIDED|95.0|-17.4|-6.5||||||Total Cholesterol||-6.5|-17.4|
73892752|NCT00035932|147318282|SUPERIORITY_OR_OTHER||Difference Estimate|-4.4|||||TWO_SIDED|95.0|-12.4|3.5||||||HDL Cholesterol||3.5|-12.4|
73892753|NCT00035932|147318282|SUPERIORITY_OR_OTHER||DIfference Estimate|-0.8|||||TWO_SIDED|95.0|-11.0|9.3||||||HDL Cholesterol||9.3|-11.0|
73892754|NCT00035932|147318282|SUPERIORITY_OR_OTHER||Difference Estimate|-8.9|||||TWO_SIDED|95.0|-19.0|1.2||||||Fasting LDL CHolesterol||1.2|-19.0|
73892755|NCT00035932|147318282|SUPERIORITY_OR_OTHER||Difference Estimate|-7.4|||||TWO_SIDED|95.0|-17.7|3.0||||||Fasting LDL Cholesterol||3.0|-17.7|
73892756|NCT00035932|147318282|SUPERIORITY_OR_OTHER||Difference Estimate|-29.6|||||TWO_SIDED|95.0|-41.6|-17.7||||||Fasting Triglycerides||-17.7|-41.6|
73892757|NCT00035932|147318282|SUPERIORITY_OR_OTHER||Difference Estimate|-38.4|||||TWO_SIDED|95.0|-49.7|-27.1||||||Fasting Triglycerides||-27.1|-49.7|
73798121|NCT00625872|147143811|SUPERIORITY_OR_OTHER|||||||1||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Flexibility): Kruskal-Wallis ANOVA model was used to calculate p-value.||||1.0000
73798122|NCT00625872|147143811|SUPERIORITY_OR_OTHER|||||||0.1234||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Go/No Go): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.1234
73798123|NCT00625872|147143811|SUPERIORITY_OR_OTHER|||||||0.3291||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Vigilance): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3291
73798124|NCT00625872|147143830|SUPERIORITY_OR_OTHER||LS Mean difference|0.14|STANDARD_ERROR_OF_MEAN|2.54||0.956|TWO_SIDED|95.0|-5.71|6.0||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||6.00|-5.71|0.9560
73798125|NCT00625872|147143846|SUPERIORITY_OR_OTHER||LS Mean difference|0.55|STANDARD_ERROR_OF_MEAN|0.31||0.1107|TWO_SIDED|95.0|-0.15|1.25||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||1.25|-0.15|0.1107
73798126|NCT00625872|147143848|SUPERIORITY_OR_OTHER||LS Mean difference|4.67|STANDARD_ERROR_OF_MEAN|1.54||0.0161|TWO_SIDED|95.0|1.13|8.21||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||8.21|1.13|0.0161
73798127|NCT00625872|147143857|SUPERIORITY_OR_OTHER||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.25||0.187|TWO_SIDED|95.0|-0.89|0.2||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Triceps SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||0.20|-0.89|0.1870
73798128|NCT00625872|147143857|SUPERIORITY_OR_OTHER||LS Mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.3494|TWO_SIDED|95.0|-0.49|0.19||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Subscapular SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||0.19|-0.49|0.3494
73798129|NCT00625872|147143857|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0458|TWO_SIDED|95.0|-0.54|-0.01||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Suprailiac SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||-0.01|-0.54|0.0458
73798130|NCT04208750|147143859|OTHER|Difference between independent proportions||||||||||||||||Added the number of participants from each study arm who preferred each refraction type and then converted it to the proportions|For each outcome, we compared the proportion of participants from both study arms who preferred the VR800 refraction to the proportion of participants who preferred the Standard refraction using a 2-sample test for equality of proportions.|||
73798131|NCT02201277|147143860|SUPERIORITY|||||||1|||||||t-test, 2 sided|||A Fisher's exact test was used to determine if there was a difference in the numbers of filters with penetration for each type. The numbers were not powered enough to make extensive tests in this area meaningful.||||1.0
73798132|NCT02201277|147143860|EQUIVALENCE|rate of penetration||||||1|||||||t-test, 1 sided|||||||1.0
73798133|NCT01512160|147143886|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-4.3|2.2||||||Analysis of co-variance (ANCOVA) model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90 percent (%) confidence interval (CI) was presented.||2.2|-4.3|
73798134|NCT01512160|147143886|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-4.1|2.3||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.||2.3|-4.1|
73798135|NCT01512160|147143886|SUPERIORITY_OR_OTHER||LS mean difference|3.5|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|0.3|6.7||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.||6.7|0.3|
73798136|NCT01512160|147143890|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-2.8|1.9||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||1.9|-2.8|
73798137|NCT01512160|147143890|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-2.7|2.0||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||2.0|-2.7|
73798138|NCT01512160|147143890|SUPERIORITY_OR_OTHER||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|0.4|5.1||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||5.1|0.4|
73798139|NCT01512160|147143890|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|7.0|||TWO_SIDED|90.0|-12.6|10.5||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||10.5|-12.6|
73798140|NCT01512160|147143890|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|6.9|||TWO_SIDED|90.0|-11.5|11.4||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||11.4|-11.5|
73892758|NCT00035932|147318283|SUPERIORITY_OR_OTHER||Difference Estimate|-14.4|||||TWO_SIDED|95.0|-20.1|-8.3|||||ATV 300/RTV - LPV/RTV|Observed values, Total Cholesterol||-8.3|-20.1|
73798141|NCT01512160|147143890|SUPERIORITY_OR_OTHER||LS mean difference|7.6|STANDARD_ERROR_OF_MEAN|7.0|||TWO_SIDED|90.0|-4.0|19.1||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||19.1|-4.0|
73798142|NCT01512160|147143891|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|90.0|-15.6|16.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||16.1|-15.6|
73798143|NCT01512160|147143891|SUPERIORITY_OR_OTHER||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|9.4|||TWO_SIDED|90.0|-16.5|14.8||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||14.8|-16.5|
73798144|NCT01512160|147143891|SUPERIORITY_OR_OTHER||LS mean difference|9.3|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|90.0|-6.6|25.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||25.1|-6.6|
73798145|NCT01512160|147143892|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.5|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.5|0.5|
73798146|NCT01512160|147143892|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|90.0|0.7|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.1|0.7|
73798147|NCT01512160|147143892|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.6|2.0||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.0|0.6|
73798148|NCT01512160|147143893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.5|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.1|0.5|
73798149|NCT01512160|147143893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|90.0|0.4|1.8||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.8|0.4|
73798150|NCT01512160|147143893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|90.0|0.7|2.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.9|0.7|
73798151|NCT01512160|147143894|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.6|1.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.9|0.6|
73798152|NCT01512160|147143894|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|90.0|0.7|2.4||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.4|0.7|
73798153|NCT01512160|147143894|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|90.0|0.4|1.3||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.3|0.4|
73892759|NCT00035932|147318283|SUPERIORITY_OR_OTHER||Difference Estimate|-9.0|||||TWO_SIDED|95.0|-16.1|-1.3|||||ATV 400/SQV - LPV/RTV|observed values, total cholesterol||-1.3|-16.1|
73798154|NCT01959295|147143922|SUPERIORITY|||||||0.5086|||||||Mantel Haenszel|||The superiority of ASP2151 200mg to ASP2151 placebo was assessed by Mantel-Haenszel method, adjusted by disease type (labial/facial herpes and recurrent genital herpes) .||||0.5086
73798155|NCT03367572|147143939|SUPERIORITY||Mean Difference (Net)|0.7056||||0.008|TWO_SIDED||||||ANOVA|||||||0.008
73798156|NCT03367572|147143939|SUPERIORITY||Mean Difference (Net)|1.1486|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
73798157|NCT03367572|147143940|SUPERIORITY||Mean Difference (Net)|0.4468||||0.01|TWO_SIDED||||||ANOVA|||||||0.010
73798158|NCT03367572|147143940|SUPERIORITY||Mean Difference (Net)|0.5632||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
73798159|NCT03367572|147143941|SUPERIORITY||Mean Difference (Net)|-0.59||||0.019|TWO_SIDED||||||t-test, 2 sided|||"Secondary Aim 1 is to determine if olanzapine is more effective than prochlorperazine in controlling nausea at Cycle 2 in participants who experienced CINV at Cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.~This will be assessed by estimating the contrast D = (3 - 1) - (2 - 1), where 3 is the Arm 3 mean, 2 is the Arm 2 mean, and 1 is the Control mean, and testing whether D = 0 versus the one-sided alternative hypothesis that D \> 0."||||0.019
73798160|NCT03367572|147143942|SUPERIORITY||Odds Ratio (OR)|1.31||||0.386|TWO_SIDED|97.5|0.65|2.66||prochlorperazine arm statistics|Regression, Logistic|||||2.66|0.65|0.386
73798161|NCT03367572|147143942|SUPERIORITY||Odds Ratio (OR)|0.16||||0.036|TWO_SIDED|97.5|0.02|1.13||olanzapine arm statistics|Regression, Logistic|||||1.13|0.02|0.036
73798162|NCT05878093|147143980|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.53|-1.15|||ANCOVA||Data was analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-1.15|-2.53|<0.0001
73798163|NCT05878093|147143981|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-0.54||||0.0126|TWO_SIDED|95.0|-0.97|-0.12|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.12|-0.97|0.0126
73798164|NCT05878093|147143982|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-1.68||||0.0008|TWO_SIDED|95.0|-2.67|-0.69|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.69|-2.67|0.0008
73892760|NCT00035932|147318283|SUPERIORITY_OR_OTHER||Difference Estimate|-11.0|||||TWO_SIDED|95.0|-19.9|-1.2|||||ATV 300/RTV - LPV/RTV|observed values, HDL cholesterol||-1.2|-19.9|
73798165|NCT05878093|147143983|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-0.62||||0.0072|TWO_SIDED|95.0|-1.08|-0.17|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.17|-1.08|0.0072
73798166|NCT05878093|147143984|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-9.52||||0.0104|TWO_SIDED|95.0|-16.81|-2.24|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-2.24|-16.81|0.0104
73798167|NCT03690388|147143992|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|96.0|0.13|0.36|||Log Rank|||||0.36|0.13|< 0.0001
73798168|NCT04100018|147143997|SUPERIORITY||Cox Proportional Hazard|0.96||||0.5901|TWO_SIDED|99.0|0.77|1.19||Boundary for statistical significance p-value \< 0.01|Log Rank|Stratification factor is visceral disease (YES vs NO) as entered in the IRT.||||1.19|0.77|0.5901
73798169|NCT04100018|147143998|SUPERIORITY||Cox Proportional Hazard|1.09||||0.3572|TWO_SIDED|99.41|0.84|1.43||Boundary for statistical significance p-value \< 0.0059. Additional accuracy for p-value: 0.005866.|Log Rank||Stratification factor is visceral disease (YES vs NO) as entered in the IRT.|||1.43|0.84|0.3572
73798170|NCT04100018|147143999|SUPERIORITY||Adjusted Difference|3.8|||||TWO_SIDED|95.0|-4.5|12.1|||||Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.|||12.1|-4.5|
73798171|NCT04100018|147144002|SUPERIORITY||Percentage Difference|0.9|||||TWO_SIDED|95.0|-5.2|7.0|||||Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.|||7.0|-5.2|
73798172|NCT04100018|147144003|SUPERIORITY||Cox Proportional Hazard|1.0|||||TWO_SIDED|95.0|0.86|1.16|||||Stratification factor is visceral disease (YES vs NO) as entered in the IRT.|||1.16|0.86|
73798173|NCT05736861|147144014|SUPERIORITY|Decision rule based on Bayesian posterior probability of efficacy. The decision threshold was a posterior probability of 0.95. A prespecified skeptical prior for the treatment effect was used to preserve type I error below 0.05.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.96|1.17|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.17|0.96|
73798174|NCT05736861|147144015|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.4|2.6|||||The interval is a highest-density credible interval. Descriptive analysis is a maximum partial likelihood proportional hazards regression model. Low event rate precluded covariate adjustment.|||2.6|0.4|
73892761|NCT00035932|147318283|SUPERIORITY_OR_OTHER||Difference Estimate|-4.1|||||TWO_SIDED|95.0|-14.0|7.0|||||ATV 400/SQV - LPV/RTV|Observed values, HDL cholesterol||7.0|-14.0|
73892762|NCT00035932|147318283|SUPERIORITY_OR_OTHER||Difference Estimate|-12.7|||||TWO_SIDED|95.0|-22.3|-1.8|||||ATV 300/RTV - LPV/RTV|observed cases, fasting LDL||-1.8|-22.3|
73798175|NCT05736861|147144018|SUPERIORITY|Statistical analysis was a Bayesian proportional hazards regression model with covariate adjustment and weakly informative priors.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.6|1.8|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.8|0.6|
73798176|NCT05736861|147144019|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.5|1.13|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|||1.13|0.50|
73798177|NCT05736861|147144020|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.39|1.13|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|||1.13|0.39|
73892763|NCT00035932|147318283|SUPERIORITY_OR_OTHER||Difference Estimate|-7.9|||||TWO_SIDED|95.0|-19.0|4.8|||||ATV 400/SQV - LPV/RTV|Observed Cases, Fasting LDL cholesterol||4.8|-19.0|
73798178|NCT05736861|147144021|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.52|1.91|||||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|1.91|0.52|
73798179|NCT05736861|147144022|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.82|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.25|0.82|
73798180|NCT05736861|147144022|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.78|1.23|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.23|0.78|
73798181|NCT05736861|147144022|OTHER||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.82|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.41|0.82|
73798182|NCT05736861|147144022|OTHER||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.57|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.01|0.57|
73892764|NCT00035932|147318283|SUPERIORITY_OR_OTHER||Difference Estimate|-24.8|||||TWO_SIDED|95.0|-38.6|-8.0|||||ATV 300/RTV - LPV/RTV|observed cases, fasting triglycerides||-8.0|-38.6|
73892765|NCT00035932|147318283|SUPERIORITY_OR_OTHER||Difference Estimate|-19.8|||||TWO_SIDED|95.0|-36.5|1.3|||||ATV 400/SQV - LPV/RTV|observed cases, fasting triglycerides||1.3|-36.5|
73892766|NCT00035932|147318294|SUPERIORITY_OR_OTHER||time-averaged difference|0.14|||||TWO_SIDED|97.5|-0.13|0.41|||||ATV 300/RTV - LPV/RTV|overall||0.41|-0.13|
73798183|NCT05736861|147144023|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.92|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.32|0.92|
73798184|NCT05736861|147144023|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.83|1.22|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.22|0.83|
73798185|NCT05736861|147144023|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.83|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.24|0.83|
73798186|NCT05736861|147144023|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.72|1.1||||||Day 90|Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|1.10|0.72|
73798187|NCT05736861|147144024|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.20|0.80|
73798188|NCT05736861|147144024|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.78|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.25|0.78|
73798189|NCT05736861|147144024|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.86|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.43|0.86|
73798190|NCT05736861|147144024|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.66|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.12|0.66|
73798191|NCT05736861|147144025|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.87|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.35|0.87|
73798192|NCT05736861|147144025|OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.96|1.57|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.57|0.96|
73798193|NCT05736861|147144025|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.92|1.54|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.54|0.92|
73798194|NCT05736861|147144025|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.71|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.18|0.71|
73798195|NCT05736861|147144026|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.97|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.47|0.97|
73798196|NCT05736861|147144026|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.33|0.84|
73798197|NCT05736861|147144026|OTHER||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.95|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.55|0.95|
73798198|NCT05736861|147144026|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.73|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.19|0.73|
73798199|NCT05736861|147144027|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.86|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.26|0.86|
73798200|NCT05736861|147144027|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.85|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.29|0.85|
73798201|NCT05736861|147144027|OTHER||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.85|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.34|0.85|
73798202|NCT05736861|147144027|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.28|0.80|
73798203|NCT05736861|147144028|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.88|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.27|0.88|
73798204|NCT05736861|147144028|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.79|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.14|0.79|
73798205|NCT05736861|147144028|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.75|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.09|0.75|
73798206|NCT05736861|147144028|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.93|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.36|0.93|
73798207|NCT05736861|147144029|SUPERIORITY||Difference in model estimate time unwell|-0.49|||||TWO_SIDED|95.0|-0.82|-0.15|||||The interval is a highest-density credible interval.|||-0.15|-0.82|
73798208|NCT05736861|147144030|SUPERIORITY||Difference in model estimated means|0.59|||||TWO_SIDED|95.0|0.18|0.99|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.99|0.18|
73798209|NCT00879255|147144031|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.75|||>|0.05|TWO_SIDED|95.0|-11.92|2.42||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority analysis|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||2.42|-11.92|> .05
73798210|NCT00879255|147144032|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.76|||>|0.05|TWO_SIDED|95.0|-11.65|2.13||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority design|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||2.13|-11.65|> .05
73798211|NCT00879255|147144033|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-5.56|||>|0.05|TWO_SIDED|95.0|-16.26|5.14||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority test|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||5.14|-16.26|> .05
73798212|NCT01130532|147144039|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73798213|NCT01130532|147144039|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73798214|NCT01130532|147144040|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|0.69|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798215|NCT01130532|147144040|SUPERIORITY_OR_OTHER||LS Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|0.68|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798216|NCT01130532|147144041|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798217|NCT01130532|147144041|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798218|NCT01130532|147144042|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73892767|NCT00035932|147318294|SUPERIORITY_OR_OTHER||time-averaged difference|0.11|||||TWO_SIDED|97.5|-0.16|0.38|||||ATV 300/RTV - LPV/RTV|last observation carried forward||0.38|-0.16|
73798219|NCT01130532|147144042|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798220|NCT01130532|147144043|SUPERIORITY_OR_OTHER||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|2.28|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798221|NCT01130532|147144043|SUPERIORITY_OR_OTHER||LS Mean Difference|9.6|STANDARD_ERROR_OF_MEAN|2.26|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798222|NCT01130532|147144043|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.14|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798223|NCT01130532|147144043|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.12|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798224|NCT01130532|147144043|SUPERIORITY_OR_OTHER||LS Mean Difference|24.7|STANDARD_ERROR_OF_MEAN|3.53|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798225|NCT01130532|147144043|SUPERIORITY_OR_OTHER||LS Mean Difference|26.8|STANDARD_ERROR_OF_MEAN|3.5|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798226|NCT01130532|147144043|SUPERIORITY_OR_OTHER||LS Mean Difference|32.7|STANDARD_ERROR_OF_MEAN|3.82|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798227|NCT01130532|147144043|SUPERIORITY_OR_OTHER||LS Mean Difference|31.3|STANDARD_ERROR_OF_MEAN|3.79|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798228|NCT01130532|147144043|SUPERIORITY_OR_OTHER||LS Mean Difference|33.0|STANDARD_ERROR_OF_MEAN|3.78|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798229|NCT01130532|147144043|SUPERIORITY_OR_OTHER||LS Mean Difference|30.5|STANDARD_ERROR_OF_MEAN|3.75|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798230|NCT01130532|147144044|SUPERIORITY_OR_OTHER||LS Mean Difference|23.1|STANDARD_ERROR_OF_MEAN|2.49|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798231|NCT01130532|147144044|SUPERIORITY_OR_OTHER||LS Mean Difference|25.4|STANDARD_ERROR_OF_MEAN|2.48|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798232|NCT01130532|147144044|SUPERIORITY_OR_OTHER||LS Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|2.36|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798233|NCT01130532|147144044|SUPERIORITY_OR_OTHER||LS Mean Difference|20.6|STANDARD_ERROR_OF_MEAN|2.35|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798234|NCT01130532|147144044|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|2.21|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798235|NCT01130532|147144044|SUPERIORITY_OR_OTHER||LS Mean Difference|19.5|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798236|NCT01130532|147144044|SUPERIORITY_OR_OTHER||LS Mean Difference|26.0|STANDARD_ERROR_OF_MEAN|2.54|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798237|NCT01130532|147144044|SUPERIORITY_OR_OTHER||LS Mean Difference|28.7|STANDARD_ERROR_OF_MEAN|2.53|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798238|NCT01130532|147144044|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|2.65|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798239|NCT01130532|147144044|SUPERIORITY_OR_OTHER||LS Mean Difference|20.1|STANDARD_ERROR_OF_MEAN|2.64|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798240|NCT01130532|147144045|SUPERIORITY_OR_OTHER||LS Mean Difference|28.9|STANDARD_ERROR_OF_MEAN|2.77|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
73798241|NCT01130532|147144045|SUPERIORITY_OR_OTHER||LS Mean Difference|31.0|STANDARD_ERROR_OF_MEAN|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
73798242|NCT01130532|147144046|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798243|NCT01130532|147144046|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798244|NCT01130532|147144047|SUPERIORITY_OR_OTHER||LS Mean Difference|21.7|STANDARD_ERROR_OF_MEAN|2.81|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798245|NCT01130532|147144047|SUPERIORITY_OR_OTHER||LS Mean Difference|25.2|STANDARD_ERROR_OF_MEAN|2.78|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798246|NCT01130532|147144047|SUPERIORITY_OR_OTHER||LS Mean Difference|22.3|STANDARD_ERROR_OF_MEAN|2.46|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798247|NCT01130532|147144047|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|STANDARD_ERROR_OF_MEAN|2.44|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798248|NCT01130532|147144047|SUPERIORITY_OR_OTHER||LS Mean Difference|16.9|STANDARD_ERROR_OF_MEAN|2.37|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798249|NCT01130532|147144047|SUPERIORITY_OR_OTHER||LS Mean Difference|17.2|STANDARD_ERROR_OF_MEAN|2.35|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798250|NCT01130532|147144047|SUPERIORITY_OR_OTHER||LS Mean Difference|25.2|STANDARD_ERROR_OF_MEAN|2.57|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798251|NCT01130532|147144047|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|STANDARD_ERROR_OF_MEAN|2.56|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798252|NCT01130532|147144047|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1|STANDARD_ERROR_OF_MEAN|2.88|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798253|NCT01130532|147144047|SUPERIORITY_OR_OTHER||LS Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|2.86|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
73798254|NCT01130532|147144048|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|STANDARD_ERROR_OF_MEAN|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
73892768|NCT02268175|147318302|SUPERIORITY|||||||0.151||||||1-sided|Fisher Exact|||The hypothesis was that treatment with ARM 1 will have a pCR/MRD rate of 35% compared with Arm 2 rate of 10%. Given 75 men randomized in 2:1 ratio to Arm 1 (N=50) or Arm 2 (N=25), there was 84% power to detect this difference, using Fisher's exact test with one-sided type I error of 0.1.||||0.151
73798255|NCT01130532|147144048|SUPERIORITY_OR_OTHER||LS Mean Difference|28.2|STANDARD_ERROR_OF_MEAN|2.74|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
73798256|NCT01130532|147144050|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
73798257|NCT01130532|147144050|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
73798258|NCT01130532|147144050|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
73798259|NCT01130532|147144051|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||0.002
73798260|NCT01130532|147144051|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||0.004
73798261|NCT01130532|147144051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
73798262|NCT03041311|147144058|SUPERIORITY||||||<|0.0001|ONE_SIDED|95.0||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|non-parametric ANCOVA|Hochberg-based gatekeeping procedure||Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect.||||<0.0001
73798263|NCT03041311|147144059|SUPERIORITY||||||<|0.0001||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||The occurrence of SN was a binary variable. Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline ANC count as a covariate, the stratification factors of ECOG performance status (0 to1 vs. 2) and brain metastases (Yes vs. No), and treatment as a fixed effect. The logarithm transformation of # of Induction cycles was included as an offset variable in the modeling.||||<0.0001
73798264|NCT03041311|147144060|SUPERIORITY|||||||0.0195||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|negative binomial regression|Hochberg-based gatekeeping procedure||||||0.0195
73798265|NCT03041311|147144061|SUPERIORITY|||||||0.1335||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||Treatment group difference was analyzed using a modified Poisson regression model. The model included baseline hemoglobin as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No) and treatment as a fixed effect. The logarithm transformation of the number of weeks on treatment was included as an offset variable in the model.||||0.1335
73798266|NCT03041311|147144062|SUPERIORITY|||||||0.0686||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline absolute neutrophil count as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect. The logarithm transformation of number of Induction cycles was included as an offset variable in the modeling.||||0.0686
73798267|NCT03041311|147144063|SUPERIORITY|For time-to-event variable, the Kaplan-Meier method was used to estimate its within group median value, 25% and 75% percentile values.|Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.218||0.9942|TWO_SIDED|95.0|0.64|1.52||The 2-sided p-value was obtained from the stratified log-rank test to account for the stratification factors.|Log Rank|stratified log-rank test|The HR and its 95% CI were calculated using the Cox proportional hazard regression model with treatment and stratification factors of ECOG performance status (0 to 1 versus 2) and presence of brain metastases (Yes versus No).|||1.52|0.64|0.9942
73798268|NCT04909853|147144094|OTHER||Ratio of Adjusted Geometric Means|129.78|||||TWO_SIDED|90.0|101.93|165.25|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||165.25|101.93|
73798269|NCT04909853|147144094|OTHER||Ratio of Adjusted Geometric Means|138.12|||||TWO_SIDED|90.0|113.18|168.55|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||168.55|113.18|
73798270|NCT04909853|147144094|OTHER||Ratio of Adjusted Geometric Means|148.02|||||TWO_SIDED|90.0|111.4|196.68|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||196.68|111.40|
73798271|NCT04909853|147144095|OTHER||Ratio of Adjusted Geometric Means|123.84|||||TWO_SIDED|90.0|99.64|153.91|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||153.91|99.64|
73798272|NCT04909853|147144095|OTHER||Ratio of Adjusted Geometric Means|187.4|||||TWO_SIDED|90.0|148.52|236.46|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||236.46|148.52|
73798273|NCT04909853|147144095|OTHER||Ratio of Adjusted Geometric Means|304.49|||||TWO_SIDED|90.0|237.6|390.21|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||390.21|237.60|
73798274|NCT00629018|147144158|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Log Rank|||The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.||||0.01
73798275|NCT02045446|147144164|SUPERIORITY||Hazard Ratio (HR)|0.304||||0.01|TWO_SIDED|95.0|0.113|0.815|||Log Rank|||||0.815|0.113|.01
73798276|NCT04090125|147144170|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.485|TWO_SIDED|95.0|-0.9|0.43|||Mixed Models Analysis|||||0.43|-0.90|0.485
73798277|NCT04090125|147144171|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.0887|TWO_SIDED|95.0|-1.13|0.08|||Mixed Models Analysis|||||0.08|-1.13|0.0887
73798278|NCT04090125|147144172|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.296|TWO_SIDED|95.0|-0.05|0.13|||Mixed Models Analysis|||||0.13|-0.05|0.296
73798279|NCT04090125|147144173|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.094|TWO_SIDED|95.0|-0.15|0.01|||Mixed Models Analysis|||||0.01|-0.15|0.094
73798280|NCT04090125|147144174|SUPERIORITY||Mean Difference (Final Values)|3.85||||0.11|TWO_SIDED|95.0|-0.91|8.62|||Mixed Models Analysis|||||8.62|-0.91|0.11
73798281|NCT04090125|147144175|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.55|TWO_SIDED|95.0|-4.1|7.59|||Mixed Models Analysis|||||7.59|-4.10|0.55
73798282|NCT04090125|147144176|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.134|TWO_SIDED|95.0|-0.34|0.05|||Mixed Models Analysis|||||0.05|-0.34|0.134
73798283|NCT04090125|147144177|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.09|TWO_SIDED|95.0|-0.38|0.03|||Mixed Models Analysis|||||0.03|-0.38|0.09
73798284|NCT04090125|147144178|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.25|TWO_SIDED|95.0|-0.16|0.04|||Mixed Models Analysis|||||0.04|-0.16|0.25
73798285|NCT04090125|147144179|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.16|TWO_SIDED|95.0|-0.22|0.04|||Mixed Models Analysis|||||0.04|-0.22|0.16
73798286|NCT04090125|147144180|SUPERIORITY||Mean Difference (Final Values)|21.36||||0.167|TWO_SIDED|95.0|-9.29|52.02|||Mixed Models Analysis|||||52.02|-9.29|0.167
73798287|NCT04090125|147144181|SUPERIORITY||Mean Difference (Final Values)|25.15||||0.189|TWO_SIDED|95.0|-12.85|63.14|||Mixed Models Analysis|||||63.14|-12.85|0.189
73798288|NCT04090125|147144186|SUPERIORITY||Mean Difference (Final Values)|2.51||||0.42|TWO_SIDED|95.0|-3.65|8.67|||Mixed Models Analysis|||Pain subscale||8.67|-3.65|0.42
73798289|NCT04090125|147144186|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.76|TWO_SIDED|95.0|-6.29|8.57|||Mixed Models Analysis|||Symptoms subscale||8.57|-6.29|0.76
73798290|NCT04090125|147144186|SUPERIORITY||Mean Difference (Final Values)|-3.54||||0.46|TWO_SIDED|95.0|-13.2|6.12|||Mixed Models Analysis|||Quality of life subscale||6.12|-13.20|0.46
73798291|NCT04090125|147144186|SUPERIORITY||Mean Difference (Final Values)|2.54||||0.22|TWO_SIDED|95.0|-1.61|6.69|||Mixed Models Analysis|||Function in daily life||6.69|-1.61|0.22
73798292|NCT04090125|147144187|SUPERIORITY||Mean Difference (Final Values)|1.43||||0.65|TWO_SIDED|95.0|-4.98|7.85|||Mixed Models Analysis|||Pain subscale||7.85|-4.98|0.65
73798293|NCT04090125|147144187|SUPERIORITY||Mean Difference (Final Values)|3.95||||0.32|TWO_SIDED|95.0|-3.93|11.83|||Mixed Models Analysis|||Symptoms subscale||11.83|-3.93|0.32
73798294|NCT04090125|147144187|SUPERIORITY||Mean Difference (Final Values)|1.64||||0.77|TWO_SIDED|95.0|-9.61|12.89|||Mixed Models Analysis|||Quality of life||12.89|-9.61|0.77
73798295|NCT04090125|147144187|SUPERIORITY||Mean Difference (Final Values)|3.25||||0.19|TWO_SIDED|95.0|-1.67|8.17|||Mixed Models Analysis|||Function in daily life||8.17|-1.67|0.19
73798296|NCT04090125|147144188|SUPERIORITY||Mean Difference (Final Values)|-1.95||||0.191|TWO_SIDED|95.0|-4.92|1.01|||Mixed Models Analysis|||||1.01|-4.92|0.191
73798297|NCT04090125|147144189|SUPERIORITY||Mean Difference (Final Values)|-5.45||||0.0004|TWO_SIDED|95.0|-8.28|-2.62|||Mixed Models Analysis|||||-2.62|-8.28|0.0004
73798298|NCT01342081|147144190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.1|-1.3|||ANCOVA|||||-1.3|-2.1|< 0.001
73798299|NCT01342081|147144190|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.5 mmHg was used. Non-inferiority was claimed if the upper limit of the confidence interval of the difference is 1.5 mmHg or less.|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.7|0.1||||||Non-inferiority was evaluated after superiority to tafluprost was confirmed.||0.1|-0.7|
73798300|NCT00114140|147144246|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Z-test|||Assuming exponential distribution of survival times, the null hypothesis was a 43% increase in median survival time (40.5 mo. to 57.9 mo.) and a 21% increase in 3-year survival rate (54% to 65%). Assuming 5% ineligibility, 72 patients were required to be accrued over 3 years with 3-years of follow-up resulting in 80% power and 1-sided 0.10 significance level. (N later increased to 135 to accommodate an additional separate analysis of O-6-Methylguanine-DNA Methyltransferase (MGMT) status.)||||<0.001
73798301|NCT00114140|147144248|SUPERIORITY||Hazard Ratio (HR)|3.52||||0.0006|TWO_SIDED|95.0|1.64|7.56||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Overall survival: The sample size was increased to 135 to ensure adequate power to detect a hazard ratio (HR) of 2.5 for MGMT status, at a 2-sided significance level of 0.05 with an MGMT prevalence rate of at least 30%||7.56|1.64|0.0006
73798302|NCT00114140|147144248|SUPERIORITY||Hazard Ratio (HR)|3.06||||0.0007|TWO_SIDED|95.0|1.55|6.04||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Progression-free survival||6.04|1.55|0.0007
73798303|NCT03885661|147144268|SUPERIORITY|||||||0.65|||||||mixed effects regression|testing for the outcome employed mixed effects regression. The key fixed effects were group assignment, period, and the group X period interaction.||||||0.65
73798304|NCT00535405|147144331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-17.5|-12.0||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-12.0|-17.5|<0.001
73798305|NCT00535405|147144331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-10.3|-4.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-4.8|-10.3|<0.001
73798306|NCT00535405|147144331|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-11.0|-5.5||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-5.5|-11.0|<0.001
73798307|NCT00535405|147144332|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|12.62|STANDARD_ERROR_OF_MEAN|3.23|<|0.001||95.0|7.64|20.83||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|"Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.~Generalized Estimating Equations (GEE)"|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||20.83|7.64|<0.001
73798308|NCT00535405|147144332|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.83|STANDARD_ERROR_OF_MEAN|0.83|<|0.001||95.0|2.51|5.85||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||5.85|2.51|<0.001
73798309|NCT00535405|147144332|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.66|STANDARD_ERROR_OF_MEAN|0.79|<|0.001||95.0|2.39|5.6|||Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||5.60|2.39|<0.001
73798310|NCT00535405|147144333|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.05|STANDARD_ERROR_OF_MEAN|0.62|<|0.001||95.0|2.04|4.55||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.55|2.04|<0.001
73798311|NCT00535405|147144333|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.54|STANDARD_ERROR_OF_MEAN|0.32||0.039||95.0|1.02|2.32||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.32|1.02|0.039
73798312|NCT00535405|147144333|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.81|STANDARD_ERROR_OF_MEAN|0.43||0.023||95.0|1.14|2.87||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.87|1.14|0.023
73798313|NCT00535405|147144334|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|4.47|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|2.76|7.24||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||7.24|2.76|<0.001
73798314|NCT00535405|147144334|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.77|STANDARD_ERROR_OF_MEAN|0.46||0.026||95.0|1.07|2.94||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.94|1.07|0.026
73798315|NCT00535405|147144334|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.27|STANDARD_ERROR_OF_MEAN|0.71||0.017||95.0|1.23|4.18||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.18|1.23|0.017
73892769|NCT04413617|147318307|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.163||0.0158|TWO_SIDED|90.0|-0.62|-0.08|||Mixed Model Repeated Measures|||The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.||-0.08|-0.62|0.0158
73798316|NCT00535405|147144335|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|7.6|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0|4.31|13.42||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||13.42|4.31|<0.001
73798317|NCT00535405|147144335|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.95|STANDARD_ERROR_OF_MEAN|0.69|<|0.001||95.0|1.86|4.67||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.67|1.86|<0.001
73798318|NCT00535405|147144335|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.15|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|1.42|3.27||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||3.27|1.42|<0.001
73798319|NCT00535405|147144336|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|6.02|STANDARD_ERROR_OF_MEAN|2.45|<|0.001||95.0|2.71|13.38||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||13.38|2.71|<0.001
73798320|NCT00535405|147144336|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.67|STANDARD_ERROR_OF_MEAN|0.47||0.069||95.0|0.96|2.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.60|0.96|0.069
73798321|NCT00535405|147144336|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.78|STANDARD_ERROR_OF_MEAN|0.44||0.039|TWO_SIDED|95.0|1.1|2.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.90|1.10|0.039
73798322|NCT02969044|147144341|SUPERIORITY||Mean Difference (Net)|-9.25|||<|0.001|TWO_SIDED|95.0|-14.75|-3.79|||ANCOVA|||||-3.79|-14.75|<0.001
73798323|NCT03282916|147144370|SUPERIORITY|Linear mixed-effects models (LMM) were used to assess the treatment effects on the outcome with change score from baseline as the dependent variable and treatment, study time point, and their interaction as predictors, adjusting for baseline value of the outcome.|Mean Difference (Final Values)|3.91|||<|0.05|TWO_SIDED|95.0|1.03|6.8||Not adjusted for multiple comparisons|Mixed Models Analysis|Adjusting for baseline value of ADAS-Cog11||"Null hypothesis: there is no difference in change in ADAS-Cog11 between valacyclovir and placebo treatment.~A sample size of 130 participants (65 per arm) was originally projected to detect Cohen's d of 0.50 with 80% power at 5% significance level. Recruitment target was reduced to 120 participants due to pandemic-related recruitment delays and required study completion within the extended funding timeline. For n=120, the minimum detectable effect size increased slightly to Cohen's d of 0.52."||6.80|1.03|<0.05
73798324|NCT03164616|147144374|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00093|TWO_SIDED|95.0|0.62|0.885||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and confidence interval (CI) were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. A hazard ratio (HR) \<1 favors D + SoC to be associated with a longer PFS than SoC alone.||0.885|0.620|0.00093
73798325|NCT03164616|147144375|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07581|TWO_SIDED|95.0|0.724|1.016||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. An HR \<1 favors D + SoC to be associated with a longer OS than SoC alone.||1.016|0.724|0.07581
73798326|NCT03164616|147144376|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00031|TWO_SIDED|95.0|0.6|0.86||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer PFS than SoC alone.||0.860|0.600|0.00031
73798327|NCT03164616|147144377|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.00304|TWO_SIDED|95.0|0.65|0.916||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer OS than SoC alone.||0.916|0.650|0.00304
73798328|NCT03164616|147144378|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.382|2.619||||||D + SoC vs SoC alone. An odds ratio \>1 favors D + SoC compared to SoC alone. Analysis was performed using logistic regression adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB), with the CI calculated using a profile likelihood approach.||2.619|1.382|
73798329|NCT03164616|147144378|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|1.26|2.367||||||T + D + SoC vs SoC alone. An odds ratio \>1 favors T + D + SoC compared to SoC alone. Analysis was performed using logistic regression adjusting for PD-L1 tumor expression (TC ≥50% vs TC \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB), with the CI calculated using a profile likelihood approach.||2.367|1.260|
73798330|NCT03164616|147144381|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.666|0.928|||||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. An HR \<1 favors D + SoC to be associated with a longer PFS2 than SoC alone.||0.928|0.666|
73798331|NCT03164616|147144381|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.632|0.883|||||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer PFS2 than SoC alone.||0.883|0.632|
73798332|NCT00489255|147144404|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.09|TWO_SIDED|95.0|0.17|1.11|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test for treatment was stratified by site.||The null hypothesis was no difference between treatments.||1.11|0.17|0.09
73798333|NCT00489255|147144405|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44||||0.025|TWO_SIDED|95.0|0.21|0.9|||Cochran-Mantel-Haenszel|||||0.90|0.21|0.025
73798334|NCT00489255|147144406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25||||0.005|TWO_SIDED|95.0|0.09|0.7|||Cochran-Mantel-Haenszel|||||0.70|0.09|0.005
73798335|NCT00489255|147144407|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|95.0|0.23|2.48|||Cochran-Mantel-Haenszel|||||2.48|0.23|0.65
73798336|NCT00489255|147144408|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.21||||0.32|TWO_SIDED|95.0|-0.64|0.21|||ANOVA|Treatment effect in ANOVA was adjusted for site.||||0.21|-0.64|0.32
73798337|NCT00489255|147144409|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.07||||0.001|TWO_SIDED|95.0|-1.71|-0.43|||ANOVA|||||-0.43|-1.71|0.001
73798338|NCT00489255|147144410|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.01||||0.95|TWO_SIDED|95.0|-0.2|0.19|||ANOVA|||||0.19|-0.20|0.95
73798339|NCT00489255|147144411|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site||||||0.88
73798340|NCT00489255|147144412|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site||||||0.019
73798341|NCT00489255|147144413|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Cochran-Mantel-Haenszel|||||||0.29
73798342|NCT00489255|147144414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.17|TWO_SIDED|95.0|0.5|1.1||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||1.1|0.5|0.17
73798343|NCT00489255|147144415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.008|TWO_SIDED|95.0|0.1|0.7||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||0.7|0.1|0.008
73798344|NCT00489255|147144416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.49|TWO_SIDED|95.0|0.6|1.3||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||1.3|0.6|0.49
73798345|NCT00489255|147144417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.4|TWO_SIDED|95.0|0.7|2.1|||Regression, Cox|||||2.1|0.7|0.4
73798346|NCT00489255|147144418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.62||95.0|0.6|2.3||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||2.3|0.6|0.62
73798347|NCT00489255|147144419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.96|TWO_SIDED|95.0|-3.59|3.76|||ANOVA|ANCOVA model with baseline score (score at Visit 1/Screening) as a covariate, and site and treatment as factors.||||3.76|-3.59|0.96
73798348|NCT00489255|147144420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.93|TWO_SIDED|95.0|-4.37|4.02|||ANOVA|||||4.02|-4.37|0.93
73798349|NCT00489255|147144421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.84|TWO_SIDED|95.0|-4.12|3.34|||ANOVA|||||3.34|-4.12|0.84
73798350|NCT00489255|147144422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.97||||0.25|TWO_SIDED|95.0|-2.17|8.11|||ANOVA|||||8.11|-2.17|0.25
73798351|NCT00489255|147144423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.47||||0.46|TWO_SIDED|95.0|-2.47|5.4|||ANOVA|||||5.40|-2.47|0.46
73798352|NCT00489255|147144424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.96||||0.33|TWO_SIDED|95.0|-3.13|9.06|||ANOVA|||||9.06|-3.13|0.33
73798353|NCT00489255|147144425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.93|TWO_SIDED|95.0|-5.57|6.11|||ANOVA|||||6.11|-5.57|0.93
73798354|NCT01625091|147144426|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
73798355|NCT01625091|147144427|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
73798356|NCT01625091|147144428|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
73798357|NCT01625091|147144429|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||0.98
73798358|NCT04995029|147144453|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|2.62||||0.4819|TWO_SIDED|95.0|-4.69|9.93||CMH weighted treatment difference and P-value based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Cochran-Mantel-Haenszel|Difference between DB treatment arms was compared using CMH test accounting for randomization stratification.||"Based on Phase 3 results, for the primary efficacy endpoint of INDV-6000-401, a sample size of 195 per arm was estimated to provide approximately 90% power at 2-sided 0.05 alpha level to detect a difference of 15.6%.~Since the participant population in this study had more severe OUD compared with the Phase 3 DB study, the responder rates and treatment differences were anticipated to be lower."||9.93|-4.69|0.4819
73798359|NCT04995029|147144453|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|12.24|||||TWO_SIDED|95.0|2.35|22.12|||||CMH weighted treatment difference based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl ≥14 times per week at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority 300-mg dose to 100-mg dose=99.099%.|22.12|2.35|
73798360|NCT04995029|147144453|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|11.06|||||TWO_SIDED|95.0|0.36|21.56|||||CMH weighted treatment difference and P-value based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl daily at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority of 300-mg dose to 100-mg dose=97.846%|21.56|0.36|
73798361|NCT04995029|147144453|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|15.37|||||TWO_SIDED|95.0|4.61|26.09|||||CMH weighted treatment difference based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl ≥14 times per week AND daily at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority of 300-mg dose to 100-mg dose=99.675%.|26.09|4.61|
73798362|NCT04995029|147144454|NON_INFERIORITY|Estimated by Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual induction arms. Posterior distribution of retention rate difference between arms was used to calculate posterior probability of NI of RI to SoC induction using a 10% NI margin or favorable trend of RI over SoC induction.|Bayesian beta-binomial model|11.82|||||TWO_SIDED|95.0|4.34|19.03|||||Posterior probability of RI NI to SoC, ie, (RI - SoC)\>10%=100.00%|"Null and alternative statistical hypotheses:~H0: retention rate of RI - SoC induction≤-10% (non-inferiority \[NI\] margin of 10%) HA: retention rate of RI-SoC induction\>-10%. Criterion for success (ie, demonstrating non-inferiority \[NI\]) was based on posterior probability of retention rate difference (RI-SoC)\>-10%. NI of RI to SoC induction was declared if the posterior probability was higher than 96%. The 96% critical value was chosen so that the overall 1-sided Type I error was less than 10%."||19.03|4.34|
73798363|NCT04995029|147144454|SUPERIORITY|The posterior possibility of retention rate difference (RI - SoC) greater than 0 was estimated to evaluate the superiority of RI over SoC induction|Bayesian beta-binomial model|11.82|||||TWO_SIDED|95.0|4.34|19.03|||||Posterior probability that RI treatment is superior to SoC treatment=99.90%|If the non-inferiority of rapid induction (RI) to standard of care (SoC) induction was declared, the posterior possibility of retention rate difference (RI - SoC) greater than 0 was estimated to evaluate the superiority of RI over SoC induction.||19.03|4.34|
73798364|NCT04995029|147144455|SUPERIORITY|A Wilcoxon rank sum test (Van Elteren 1960) stratified for randomisation factors was performed to compare the difference between the 2 treatment arms. The test result P-value was used inferentially, if the primary endpoint test was statistically significant.|Mean Difference (Net)|-1.73||||0.8836|TWO_SIDED|95.0|-6.83|3.36|||Wilcoxon rank sum (Van Elteren)|Wilcoxon rank sum test stratified by DB randomisation factor (Van Elteren, 1960).|Van Elteren Test Z-Score for Difference Between Arms (300 mg - 100 mg)=-0.1464|||3.36|-6.83|0.8836
73798365|NCT04995029|147144456|OTHER||CMH Difference|1.26||||0.6111|TWO_SIDED|95.0|-3.61|6.13|||Cochran-Mantel-Haenszel|CMH weighted treatment difference and p-value based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|CMH weighted treatment difference and p-value based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|Opioid abstinence between Weeks 10 to 38 (inclusive) was derived as the participant's number of visits with negative assessments (defined as negative UDS and TLFB for opioid use) divided by 15. Under this derivation, any missed or skipped visits were counted as positive, in accordance with the composite Intercurrent Events Strategy. The opioid use derivation at a specific visit was the same as that used for the primary efficacy endpoint.||6.13|-3.61|0.6111
73798366|NCT04995029|147144457|OTHER||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-6.0|7.99||||||Opioid abstinence between Weeks 10 to 38 (inclusive) was derived as his/her number of visits with negative assessments (defined as negative UDS and TLFB for opioid use) divided by 15. Under this derivation, any missed or skipped visits were counted as positive, in accordance with the composite intercurrent event strategy.||7.99|-6.00|
73798367|NCT04995029|147144458|OTHER||CMH Difference|2.73|||||TWO_SIDED|95.0|-4.98|10.43||This endpoint was summarized similar to the analysis for #4 above. The opioid abstinence percentage for an individual participant was derived as his/her number of visits with negative assessments divided by 5.|||CMH weighted treatment difference based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|||10.43|-4.98|
73798368|NCT04995029|147144459|OTHER||CMH Difference|0.15|||||TWO_SIDED|95.0|-7.49|7.78|||||CMH weighted treatment difference based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|||7.78|-7.49|
73798369|NCT04995029|147144460|OTHER||Mean Difference (Net)|1.49|||||TWO_SIDED|95.0|-4.8|7.78||||||||7.78|-4.80|
73798370|NCT04995029|147144461|OTHER||Mean Difference (Net)|-0.64|||||TWO_SIDED|95.0|-5.38|4.09||||||||4.09|-5.38|
73798371|NCT04995029|147144462|OTHER||Mean Difference (Net)|-1.37|||||TWO_SIDED|95.0|-9.0|6.25||||||||6.25|-9.00|
73798372|NCT04995029|147144468|OTHER||CMH Difference|1.54|||||TWO_SIDED|95.0|-7.56|10.65|||||CMH weighted treatment difference based on the CMH randomisation stratified analysis using the Sato (1989) variance equation.|||10.65|-7.56|
73798373|NCT04995029|147144469|OTHER||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.65|1.03|||||Estimated using a Cox proportional hazard model, with treatment arm as a single covariate, stratified by the randomisation strata. Note that the estimation is impacted by last observed visit for the OLTP (including out-of-window visits).|||1.03|0.65|
73798374|NCT03915652|147144472|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.34|TWO_SIDED|95.0|-2.88|1.02|||t-test, 2 sided|Paired t-test||Waves 1 and 2 were combined and appointment nonadherence during the intervention was compared with the 12 months prior.||1.02|-2.88|0.34
73798375|NCT03915652|147144473|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.34|TWO_SIDED|95.0|-1.08|0.39|||t-test, 2 sided|Paired t-test||Waves 1 and 2 were combined and emergency department visits and hospitalizations during the intervention was compared with the 12 months prior.||0.39|-1.08|0.34
73798376|NCT03915652|147144474|SUPERIORITY||Mean Difference (Final Values)|0.59|||<|0.001|TWO_SIDED|95.0|0.45|0.73|||t-test, 1 sided|One sided t-test of percent of needs remaining from 100%.||Wave 1 and Wave 2 were combined and the quality metric at the end of the 12-month intervention was compared to the metric from the start of the intervention.||0.73|0.45|<0.001
73798377|NCT03915652|147144475|SUPERIORITY||Mean Difference (Final Values)|7.5||||0.51|TWO_SIDED|95.0|-19.8|34.8|||t-test, 2 sided|||||34.8|-19.8|0.51
73798378|NCT03915652|147144476|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.17|TWO_SIDED|95.0|-0.43|1.92|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, compared post to pre.||1.92|-0.43|0.17
73798379|NCT03915652|147144477|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.72|TWO_SIDED|95.0|-4.92|6.52|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, compared pre/post intervention||6.52|-4.92|0.72
73798380|NCT03915652|147144478|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.5|TWO_SIDED|95.0|-6.22|10.22|||t-test, 2 sided|||Waves 1 and 2 are combined; pre/post survey analysis||10.22|-6.22|0.50
73798381|NCT03915652|147144479|SUPERIORITY||Mean Difference (Final Values)|3.77||||0.01|TWO_SIDED|95.0|1.06|6.47|||t-test, 2 sided|||Waves 1 and 2 combined; pre/post analysis||6.47|1.06|0.01
73798382|NCT03915652|147144480|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.77|TWO_SIDED|95.0|-1.27|0.98|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, pre/post test||0.98|-1.27|0.77
73798383|NCT03915652|147144481|SUPERIORITY||Mean Difference (Final Values)|2.14||||0.37|TWO_SIDED|95.0|-3.23|7.52|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined; pre/post analysis||7.52|-3.23|0.37
73798384|NCT01295112|147144482|SUPERIORITY|||||||2e-05|||||||Cochran-Mantel-Haenszel|||||||0.00002
73798385|NCT01295112|147144483|NON_INFERIORITY|Non-inferiority will be described by the 95% upper bound of the confidence interval on the difference in the improvement from baseline in BCVA|Mean Difference (Final Values)|2.51|STANDARD_DEVIATION|17.96||0.53|TWO_SIDED|90.0|-4.43|9.74||The p-value is assume superiority. The 95% upper confidence (upper end of the 90% Confidence interval) interval for the non-inferiority analysis is provided below.|t-test, 1 sided|||||9.74|-4.43|0.53
73798386|NCT03071692|147144484|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.92|1.16||||||||1.16|0.92|
73798387|NCT03071692|147144485|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.92|1.2||||||||1.20|0.92|
73798388|NCT03071692|147144486|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.89|1.18||||||||1.18|0.89|
73798389|NCT03071692|147144487|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.93|1.16||||||||1.16|0.93|
73798390|NCT03071692|147144488|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.93|1.13||||||||1.13|0.93|
73798391|NCT03071692|147144489|SUPERIORITY||Event Rate Ration|0.99|||||TWO_SIDED|95.0|0.87|1.13||||||||1.13|0.87|
73798392|NCT03071692|147144490|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.09||||||||1.09|0.69|
73798393|NCT03071692|147144491|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.95|1.41||||||||1.41|0.95|
73798394|NCT03071692|147144492|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.19||||||||1.19|0.69|
73798395|NCT03071692|147144493|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.84|1.14||||||||1.14|0.84|
73798396|NCT03071692|147144494|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.83|1.32||||||||1.32|0.83|
73798397|NCT03071692|147144495|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.75|1.26||||||TT Variant||1.26|0.75|
73798398|NCT03071692|147144495|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.96|1.47||||||CT Variant||1.47|0.96|
73798399|NCT03071692|147144495|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.69|1.39||||||CC Variant||1.39|0.69|
73798400|NCT03071692|147144496|SUPERIORITY|||||||0.13496|||||||ANCOVA|||||||0.13496
73798401|NCT03071692|147144497|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73798402|NCT03071692|147144498|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73798403|NCT03071692|147144499|SUPERIORITY|||||||0.96689|||||||ANCOVA|||||||0.96689
73798404|NCT03071692|147144500|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73798405|NCT03071692|147144501|SUPERIORITY|||||||0.09178|||||||ANCOVA|||||||0.09178
73798406|NCT03071692|147144502|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73798407|NCT03071692|147144503|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73798408|NCT03071692|147144504|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73798409|NCT00970593|147144513|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|95.0|-1.79|0.29||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||0.29|-1.79|
73798410|NCT00970593|147144513|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.543|||TWO_SIDED|95.0|-2.98|-0.83||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-0.83|-2.98|
73798411|NCT00970593|147144513|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.15|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|95.0|-3.06|-1.24||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-1.24|-3.06|
73798412|NCT00970593|147144514|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.37|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-3.52|-1.22||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-1.22|-3.52|
73798413|NCT00970593|147144514|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.18|STANDARD_ERROR_OF_MEAN|0.495|||TWO_SIDED|95.0|-4.16|-2.2||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-2.20|-4.16|
73798414|NCT00970593|147144514|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.14|STANDARD_ERROR_OF_MEAN|0.437|||TWO_SIDED|95.0|-4.01|-2.28||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-2.28|-4.01|
73798415|NCT01339403|147144572|SUPERIORITY_OR_OTHER||Rate ratio|166.1|||<|0.001|TWO_SIDED|95.0|123.4|223.5|||Poisson Regression|||Kaposi's sarcoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||223.5|123.4|<0.001
73798416|NCT01339403|147144572|SUPERIORITY_OR_OTHER||Rate ratio|12.1|||<|0.001|TWO_SIDED|95.0|10.3|14.2|||Poisson Regression|||Invasive non-Hodgkin's lymphoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||14.2|10.3|<0.001
73798417|NCT01339403|147144572|SUPERIORITY_OR_OTHER||Rate ratio|3.4||||0.059|TWO_SIDED|95.0|1.0|12.3|||Poisson Regression|||Invasive cervical cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||12.3|1.0|0.059
73798418|NCT01339403|147144572|SUPERIORITY_OR_OTHER||Rate ratio|1.7|||<|0.001|TWO_SIDED|95.0|1.5|1.8|||Poisson Regression|||Non-AIDS-defining cancers: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||1.8|1.5|<0.001
73798419|NCT01339403|147144572|SUPERIORITY_OR_OTHER||Rate Ratio|166.1|||<|0.001|TWO_SIDED|95.0|123.4|223.5|||Poisson Regression|||AIDS-defining cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||223.5|123.4|<0.001
73798420|NCT01339403|147144573|SUPERIORITY_OR_OTHER||Rate ratio|1.4|||<|0.001|TWO_SIDED|95.0|1.3|1.5|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||1.5|1.3|<0.001
73798421|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|65.7|||<|0.001|TWO_SIDED|95.0|57.1|75.7|||Poisson Regression|||Wasting syndrome: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||75.7|57.1|<0.001
73798422|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|428.5|||<|0.001|TWO_SIDED|95.0|292.2|628.5|||Poisson Regression|||Pneumocystis jirovecii pneumonia: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||628.5|292.2|<0.001
73798423|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|8.7|||<|0.001|TWO_SIDED|95.0|7.9|9.5|||Poisson Regression|||Pneumonia, recurrent: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||9.5|7.9|<0.001
73798424|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|97.1|||<|0.001|TWO_SIDED|95.0|75.5|124.8|||Poisson Regression|||Cytomegalovirus: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||124.8|75.5|<0.001
73798425|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|60.2|||<|0.001|TWO_SIDED|95.0|48.3|74.9|||Poisson Regression|||Esophageal Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||74.9|48.3|<0.001
73798426|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|98.4|||<|0.001|TWO_SIDED|95.0|70.8|136.8|||Poisson Regression|||Mycobacterium avium complex: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||136.8|70.8|<0.001
73798427|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|189.5|||<|0.001|TWO_SIDED|95.0|112.3|319.5|||Poisson Regression|||Cryptococcosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||319.5|112.3|<0.001
73798428|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|6.2|||<|0.001|TWO_SIDED|95.0|5.2|7.4|||Poisson Regression|||Mycobacterium tuberculosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||7.4|5.2|<0.001
73798429|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|594.5|||<|0.001|TWO_SIDED|95.0|146.5|2411.7|||Poisson Regression|||Progressive multifocal leukoencephalopathy: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||2411.7|146.5|<0.001
73798430|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|10.6|||<|0.001|TWO_SIDED|95.0|7.8|14.4|||Poisson Regression|||Lung Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||14.4|7.8|<0.001
73798431|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|51.5|||<|0.001|TWO_SIDED|95.0|30.3|87.5|||Poisson Regression|||Toxoplasmosis of brain: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||87.5|30.3|<0.001
73798432|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|6.2|||<|0.001|TWO_SIDED|95.0|3.0|12.9|||Poisson Regression|||Coccidiomycosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||12.9|3.0|<0.001
73798433|NCT01339403|147144574|SUPERIORITY_OR_OTHER||Rate ratio|13.0|||<|0.0001|TWO_SIDED|95.0|7.4|23.1|||Poisson Regression|||Histoplasmosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||23.1|7.4|<0.0001
73798434|NCT01339403|147144575|SUPERIORITY_OR_OTHER||Rate ratio|4.7|||<|0.001|TWO_SIDED|95.0|4.3|5.1|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||5.1|4.3|<0.001
73798435|NCT01339403|147144576|SUPERIORITY_OR_OTHER||Rate ratio|7.0|||<|0.001|TWO_SIDED|95.0|6.0|8.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||8.2|6.0|<0.001
73798436|NCT01339403|147144577|SUPERIORITY_OR_OTHER||Rate ratio|8.3|||<|0.001|TWO_SIDED|95.0|7.1|9.6|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||9.6|7.1|<0.001
73798437|NCT01339403|147144578|SUPERIORITY_OR_OTHER||Rate ratio|5.6|||<|0.001|TWO_SIDED|95.0|5.3|5.9|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||5.9|5.3|<0.001
73798438|NCT01339403|147144579|SUPERIORITY_OR_OTHER||Rate ratio|19.8|||<|0.001|TWO_SIDED|95.0|11.2|35.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||35.2|11.2|<0.001
73798439|NCT03983980|147144580|SUPERIORITY||Risk Ratio (RR)|6.1|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
73798440|NCT03983980|147144581|SUPERIORITY||Risk Ratio (RR)|6.53|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
73798441|NCT03983980|147144582|SUPERIORITY||Risk Ratio (RR)|4.55|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
73798442|NCT03983980|147144583|SUPERIORITY||Least squares mean difference|-4.32|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73798443|NCT03983980|147144584|SUPERIORITY||Risk Ratio (RR)|7.25|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
73798444|NCT01608100|147144596|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9326|||||TWO_SIDED|95.0|0.9048|0.9604||||||Time point: 0-2 hours||0.9604|0.9048|
73798445|NCT01608100|147144596|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9431|||||TWO_SIDED|95.0|0.9081|0.9782||||||Time point: 2-4 hours||0.9782|0.9081|
73798446|NCT01608100|147144596|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9503|||||TWO_SIDED|95.0|0.9419|0.9857||||||Time point: 4-9 hours||0.9857|0.9419|
73798447|NCT01608100|147144596|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9197|||||TWO_SIDED|95.0|0.8914|0.948||||||Time point: 0-2 hours||0.9480|0.8914|
73798448|NCT01608100|147144596|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9349|||||TWO_SIDED|95.0|0.8986|0.9712||||||Time point: 2-4 hours||0.9712|0.8986|
73798449|NCT01608100|147144596|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9498|||||TWO_SIDED|95.0|0.919|0.9805||||||Time point: 4-9 hours||0.9805|0.9190|
73798450|NCT01608100|147144596|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9412|||||TWO_SIDED|95.0|0.9102|0.9722||||||Time point: 0-2 hours||0.9722|0.9102|
73798451|NCT01608100|147144596|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9419|||||TWO_SIDED|95.0|0.9041|0.9796||||||Time point: 2-4 hours||0.9796|0.9041|
73798452|NCT01608100|147144596|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9449|||||TWO_SIDED|95.0|0.9046|0.9852||||||Time point: 4-9 hours||0.9852|0.9046|
73798453|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|7.0||||0.0004|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||0.0004
73798454|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|2.31||||0.0004|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||0.0004
73798455|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.09||||0.0011|TWO_SIDED|95.0|1.59|5.95||Likelihood Ratio|Regression, Cox|||Hazard Ratio||5.95|1.59|0.0011
73798456|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|12.76|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
73892770|NCT04413617|147318307|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.164||0.3933|TWO_SIDED|90.0|-0.32|0.23|||Mixed Model Repeated Measures|||The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.||0.23|-0.32|0.3933
73798457|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|3.65|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
73798458|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.21|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|2.21|<0.0001
73798459|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|7.17|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
73798460|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|2.07|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
73798461|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.54||||0.0002|TWO_SIDED|95.0|1.84|6.87||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.87|1.84|0.0002
73798462|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|12.83|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
73798463|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|3.66|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
73798464|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.68|||<|0.0001|TWO_SIDED|95.0|2.25|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|2.25|<0.0001
73798465|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|6.07||||0.002|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||0.0020
73798466|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|2.09||||0.002|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||0.0020
73798467|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.95||||0.005|TWO_SIDED|95.0|1.41|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|1.41|0.0050
73892771|NCT00356304|147318438|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANCOVA|||||||<.05
73798468|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|12.15|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
73798469|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Proportion Percentage|3.57|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
73798470|NCT01608100|147144597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.55|||<|0.0001|TWO_SIDED|95.0|2.08|6.03||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.03|2.08|<0.0001
73798471|NCT01608100|147144598|SUPERIORITY_OR_OTHER||Percent Sensitivity|84.44|||||TWO_SIDED|95.0|75.28|91.23||||||Time point: 0-2 hours||91.23|75.28|
73892772|NCT00948441|147318442|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||t-test, 2 sided|||matched pairs T test to compare infection rates during the two study periods||||0.012
73798472|NCT01608100|147144598|SUPERIORITY_OR_OTHER||Percent Sensitivity|92.21|||||TWO_SIDED|83.81|83.81|97.09||||||Time point: 2-4 hours||97.09|83.81|
73798473|NCT01608100|147144598|SUPERIORITY_OR_OTHER||Percent Sensitivity|93.9|||||TWO_SIDED|95.0|86.34|97.99||||||Time point: 4-9 hours||97.99|86.34|
73798474|NCT01608100|147144598|SUPERIORITY_OR_OTHER||Percent Sensitivity|85.26|||||TWO_SIDED|95.0|76.51|91.7||||||Time point: 0-2 hours||91.70|76.51|
73798475|NCT01608100|147144598|SUPERIORITY_OR_OTHER||Percent Sensitivity|91.86|||||TWO_SIDED|95.0|83.95|96.66||||||Time point: 2-4 hours||96.66|83.95|
73798476|NCT01608100|147144598|SUPERIORITY_OR_OTHER||Percent Sensitivity|94.95|||||TWO_SIDED|95.0|88.61|98.34||||||Time point: 4-9 hours||98.34|88.61|
73798477|NCT01608100|147144598|SUPERIORITY_OR_OTHER||Percent Sensitivity|87.32|||||TWO_SIDED|95.0|77.3|94.04||||||Time point: 0-2 hours||94.04|77.30|
73798478|NCT01608100|147144598|SUPERIORITY_OR_OTHER||Percent Sensitivity|92.0|||||TWO_SIDED|95.0|83.4|97.01||||||Time point: 2-4 hours||97.01|83.40|
73798479|NCT01608100|147144598|SUPERIORITY_OR_OTHER||Percent Sensitivity|93.15|||||TWO_SIDED|95.0|84.74|97.74||||||Time point: 4-9 hours||97.74|84.74|
73798480|NCT01608100|147144599|SUPERIORITY_OR_OTHER||Percent Specificity|85.73|||||TWO_SIDED|95.0|83.18|88.03||||||Time point: 0-2 hours||88.03|83.18|
73798481|NCT01608100|147144599|SUPERIORITY_OR_OTHER||Percent Specificity|85.2|||||TWO_SIDED|95.0|82.66|87.5||||||Time point: 2-4 hours||87.50|82.66|
73798482|NCT01608100|147144599|SUPERIORITY_OR_OTHER||Percent Specificity|82.82|||||TWO_SIDED|95.0|79.99|85.4||||||Time point: 4-9 hours||85.40|79.99|
73798483|NCT01608100|147144599|SUPERIORITY_OR_OTHER||Percent Specificity|83.76|||||TWO_SIDED|95.0|81.12|86.17||||||Time point: 0-2 hours||86.17|81.12|
73798484|NCT01608100|147144599|SUPERIORITY_OR_OTHER||Percent Specificity|83.72|||||TWO_SIDED|95.0|81.09|86.11||||||Time point: 2-4 hours||86.11|81.09|
73798485|NCT01608100|147144599|SUPERIORITY_OR_OTHER||Percent Specificity|80.72|||||TWO_SIDED|95.0|77.82|83.39||||||Time point: 4-9 hours||83.39|77.82|
73798486|NCT01608100|147144599|SUPERIORITY_OR_OTHER||Percent Specificity|86.35|||||TWO_SIDED|95.0|83.79|88.63||||||Time point: 0-2 hours||88.63|83.79|
73798487|NCT01608100|147144599|SUPERIORITY_OR_OTHER||Percent Specificity|85.81|||||TWO_SIDED|95.0|83.31|88.07||||||Time point: 2-4 hours||88.07|83.31|
73798488|NCT01608100|147144599|SUPERIORITY_OR_OTHER||Percent Specificity|84.05|||||TWO_SIDED|95.0|81.31|86.54||||||Time point: 4-9 hours||86.54|81.31|
73798489|NCT01608100|147144600|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.1|||||TWO_SIDED|95.0|96.82|98.95||||||Time point: 0-2 hours||98.95|96.82|
73798490|NCT01608100|147144600|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.19|||||TWO_SIDED|95.0|98.25|99.7||||||Time point: 2-4 hours||99.70|98.25|
73892773|NCT02654769|147318444|EQUIVALENCE|Difference (Generic- Picato)|90% Wald's confidence interval|-1.87|||<|0.0001|TWO_SIDED|90.0|-12.37|8.63|||Fisher Exact|||||8.63|-12.37|<0.0001
73892774|NCT02654769|147318445|EQUIVALENCE|Difference (Generic - Picato)|90% Wald's confidence interval|-2.64|||<|0.0001|TWO_SIDED|90.0|-13.14|7.86|||Fisher Exact|||Partial Clearance at Week 8||7.86|-13.14|<0.0001
73892775|NCT02923921|147318464|SUPERIORITY||Hazard Ratio (HR)|1.045||||0.6565|TWO_SIDED|95.0|0.863|1.265|||Log Rank|||The primary test to compare overall survival between treatment arms was the two-sided log-rank test, stratified by region and prior therapy. The estimate of the hazard ration (HR) - (Pegilodecakin + FOLFOX Arm / FOLFOX Arm) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in interactive voice response system (IVRS).||1.265|0.863|0.6565
73892776|NCT02923921|147318465|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.8144|TWO_SIDED|95.0|0.808|1.19|||Log Rank|||The estimate of hazard ratio (HR) was stratified by region and prior therapy.||1.190|0.808|0.8144
73892777|NCT02923921|147318466|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7044|TWO_SIDED|95.0|0.4|1.7||P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.|Cochran-Mantel-Haenszel|||||1.7|0.4|0.7044
73892778|NCT02923921|147318467|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1463|TWO_SIDED|95.0|0.9|1.8||P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.|Cochran-Mantel-Haenszel|||||1.8|0.9|0.1463
73892779|NCT02923921|147318468|SUPERIORITY||Hazard Ratio (HR)|1.008||||0.9952|TWO_SIDED|95.0|0.37|2.741|||Log Rank|||The estimate of hazard ratio (HR) was stratified by region and prior therapy.||2.741|0.370|0.9952
73892780|NCT02923921|147318469|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.2298|TWO_SIDED|95.0|-11.6|2.8|||Log Rank|||||2.8|-11.6|0.2298
73892781|NCT00479687|147318470|SUPERIORITY|||||||0.038||||||There was a single primary variable and the a-prior threshold for statistical significance was 0.05.|Mixed Models Analysis|mixed effects repeated measure model with baseline VAS, treatment, and week as fixed effects and subject nested within site as a random effect.||||||0.0380
73892782|NCT01474239|147318479|SUPERIORITY_OR_OTHER|||||||0.4291|TWO_SIDED|||||Statistical significance was assessed with a one-sided alpha error of 10 percent (%).|Exact Binomial Test|||The 6-month OS rate (OS-6) for bevacizumab was compared to the expected proportion of 0.60 under null hypothesis (ineffective treatment) with the application of the exact binomial test. The one-tailed statistical hypotheses was p0 less than or equal to (≤) 0.60 (null hypothesis) versus pA greater than or equal to (≥) 0.77 (alternative hypothesis), where p is the estimated probability of survival at 6 months.||||0.4291
73798491|NCT01608100|147144600|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.23|||||TWO_SIDED|95.0|98.22|99.75||||||Time point: 4-9 hours||99.75|98.22|
73798492|NCT01608100|147144600|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.08|||||TWO_SIDED|95.0|96.81|98.95||||||Time point: 0-2 hours||98.95|96.81|
73798493|NCT01608100|147144600|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.05|||||TWO_SIDED|95.0|98.05|99.62||||||Time point: 2-4 hours||99.62|98.05|
73798494|NCT01608100|147144600|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.24|||||TWO_SIDED|95.0|98.22|99.75||||||Time point: 4-9 hours||99.75|98.22|
73798495|NCT01608100|147144600|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.73|||||TWO_SIDED|95.0|97.61|99.42||||||Time point: 0-2 hours||99.42|97.61|
73798496|NCT01608100|147144600|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.2|||||TWO_SIDED|95.0|98.27|99.71||||||Time point: 2-4 hours||99.71|98.27|
73798497|NCT01608100|147144600|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.25|||||TWO_SIDED|95.0|98.26|99.76||||||Time point: 4-9 hours||99.76|98.26|
73892783|NCT00505778|147318505|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|1.3||||0.5016|TWO_SIDED|95.0|-2.3|4.9|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||4.9|-2.3|0.5016
73798498|NCT01608100|147144601|SUPERIORITY_OR_OTHER||Positive Predictive Value|38.78|||||TWO_SIDED|95.0|31.92|45.98||||||Time point: 0-2 hours||45.98|31.92|
73798499|NCT01608100|147144601|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.68|||||TWO_SIDED|95.0|29.03|42.76||||||Time point: 2-4 hours||42.76|29.03|
73798500|NCT01608100|147144601|SUPERIORITY_OR_OTHER||Positive Predictive Value|36.49|||||TWO_SIDED|95.0|29.99|43.38||||||Time point: 4-9 hours||43.38|29.99|
73798501|NCT01608100|147144601|SUPERIORITY_OR_OTHER||Positive Predictive Value|36.82|||||TWO_SIDED|95.0|30.43|43.56||||||Time point: 0-2 hours||43.56|30.43|
73798502|NCT01608100|147144601|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.75|||||TWO_SIDED|95.0|29.43|42.45||||||Time point: 2-4 hours||42.45|29.43|
73798503|NCT01608100|147144601|SUPERIORITY_OR_OTHER||Positive Predictive Value|37.75|||||TWO_SIDED|95.0|31.71|44.09||||||Time point: 4-9 hours||44.09|31.71|
73798504|NCT01608100|147144601|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.84|||||TWO_SIDED|95.0|28.7|43.47||||||Time point: 0-2 hours||43.47|28.70|
73798505|NCT01608100|147144601|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.94|||||TWO_SIDED|95.0|29.16|43.16||||||Time point: 2-4 hours||43.16|29.16|
73798506|NCT01608100|147144601|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.05|||||TWO_SIDED|95.0|28.36|42.21||||||Time point: 4-9 hours||42.21|28.36|
73798507|NCT03440840|147144629|SUPERIORITY||Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|2.68||0.4|TWO_SIDED||||||Mixed Models Analysis|Estimated marginal means comparisons, Tukey adjustment||||||0.40
73798508|NCT03440840|147144630|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|2.04||0.37|TWO_SIDED|||||Estimated marginal means comparisons, Tukey adjustment|Mixed Models Analysis|||||||0.37
73798509|NCT03440840|147144631|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|2.04||0.37|TWO_SIDED||||||Mixed Models Analysis|Comparison of estimated marginal means, Tukey adjustment for multiple comparisons||||||0.37
73798510|NCT03440840|147144632|SUPERIORITY||Mean Difference (Final Values)|1.42|STANDARD_ERROR_OF_MEAN|2.77||0.61|TWO_SIDED||||||Mixed Models Analysis||Differences between estimated marginal means, Tukey correction for multiple comparisons.|||||0.61
73798511|NCT04688671|147144633|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.302||0.5605|TWO_SIDED|90.0|-0.32|0.68|||Mixed Models Analysis|||||0.68|-0.32|0.5605
73798512|NCT01349192|147144672|SUPERIORITY||Proportion Difference (Final Values)|0.56||||0.0005|TWO_SIDED|95.0|0.25|0.74||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.74|0.25|0.0005
73798513|NCT01349192|147144672|SUPERIORITY||Proportion Difference (Final Values)|0.525||||0.0004|TWO_SIDED|95.0|0.23|0.8||Test includes adjustment for two interim reviews of efficacy data. The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group.|||0.80|0.23|0.0004
73798514|NCT01349192|147144673|SUPERIORITY||Proportion Difference (Final Values)|0.09||||0.5463|TWO_SIDED|95.0|-0.18|0.34||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion using antibiotics in the treatment group minus the proportion using antibiotics in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.34|-0.18|0.5463
73798515|NCT01349192|147144674|SUPERIORITY||Mean Difference (Final Values)|-9.42||||0.3683|TWO_SIDED|95.0|-30.3|11.47||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided||Mean difference was calculated as mean days of antibiotic use in the treatment group minus the mean days of antibiotic use in the observation group.|||11.47|-30.3|0.3683
73798516|NCT01349192|147144675|SUPERIORITY||Proportion Difference (Final Values)|-0.2||||0.1205|TWO_SIDED|95.0|-0.42|0.03||The a priori threshold for statistical significance was 0.05.|Chi-squared||Difference was calculated as proportion with a PE treated with MRSA active antibiotics in the treatment group minus the analogous proportion in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.03|-0.42|0.1205
73798517|NCT03749330|147144688|EQUIVALENCE|test of difference between pre and post|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73798518|NCT03091179|147144757|EQUIVALENCE|P value was calculated using the means and standard deviations for each of the patient characteristics.||||||0.006|||||||t-test, 2 sided|||||||0.006
73798519|NCT00143390|147144771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.007|||||TWO_SIDED|95.0|0.771|1.317|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method||1.317|0.771|
73798520|NCT00143390|147144772|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.059|||||TWO_SIDED|95.0|0.816|1.374|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method||1.374|0.816|
73892784|NCT00505778|147318506|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.8||||0.5426|TWO_SIDED|95.0|-1.8|3.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||3.5|-1.8|0.5426
73798521|NCT03417687|147144780|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-14.7%, +14.7%).|Mean Difference (Net)|1.4|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|-0.75|3.6||||||The primary efficacy analysis tested the mean difference in the predicted percentage of remaining pulmonary function as measured by 129Xe MRI relative to the value as measured by 133Xe scintigraphy (reference standard) if a pre-defined section of lung were resected.||3.60|-0.75|
73798522|NCT03417687|147144782|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|3.71|STANDARD_DEVIATION|4.39|||TWO_SIDED|95.0|2.12|5.29||||||||5.29|2.12|
73798523|NCT03417687|147144783|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-0.476|1.26||||||||1.26|-0.476|
73798524|NCT03417687|147144784|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|1.35|STANDARD_DEVIATION|3.22|||TWO_SIDED|95.0|0.184|2.505||||||||2.505|0.184|
73798525|NCT03417687|147144785|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-0.96|STANDARD_DEVIATION|3.16|||TWO_SIDED|95.0|-2.101|0.181||||||||0.181|-2.101|
73798526|NCT03417687|147144786|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-2.721|STANDARD_DEVIATION|3.82|||TWO_SIDED|95.0|-4.096|-1.345||||||||-1.345|-4.096|
73798527|NCT03417687|147144787|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|3.96|||TWO_SIDED|95.0|-3.192|-0.335||||||||-0.335|-3.192|
73798528|NCT03180645|147144788|OTHER||Least square (LS) mean difference|-1.07||||0.0638|TWO_SIDED|95.0|-2.21|0.06|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of the face as fixed effects and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline minus the second named treatment adjusted mean change from baseline.|||0.06|-2.21|0.0638
73798529|NCT02729909|147144804|SUPERIORITY||Median Value of confidence interval (CI)|1.0||||0.02|TWO_SIDED|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||||1.9|0.1|0.020
73798530|NCT02729909|147144805|SUPERIORITY||Median Value of CI|1.0||||0.051|TWO_SIDED|95.0|0.0|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||1.9|0.0|0.051
73798531|NCT02729909|147144805|SUPERIORITY||Median Value of CI|1.5||||0.003|TWO_SIDED|95.0|1.0|2.0||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||2.0|1.0|0.003
73798532|NCT02729909|147144805|SUPERIORITY||Median Value of CI|1.0||||0.009|TWO_SIDED|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||1.9|0.1|0.009
73798533|NCT02729909|147144806|SUPERIORITY||Odds Ratio (OR)|2.08||||0.009|TWO_SIDED|95.0|1.19|3.62||The proportion of participants with an SBM within 24 hours after first dose in Week 1 is analyzed by a Cochran-Mantel-Haenszel (CMH) test stratified by center. Centers with less participants were pooled based on geographical proximity.|Cochran-Mantel-Haenszel|||||3.62|1.19|0.009
73798534|NCT02729909|147144807|SUPERIORITY||Median Value of CI|-0.4||||0.001|TWO_SIDED|95.0|-0.6|-0.2||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||-0.2|-0.6|0.001
73798535|NCT02729909|147144807|SUPERIORITY||Median Value of CI|-0.3||||0.004|TWO_SIDED|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||-0.1|-0.5|0.004
73798536|NCT02729909|147144807|SUPERIORITY||Median Value of CI|-0.2||||0.024|TWO_SIDED|95.0|-0.4|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||-0.1|-0.4|0.024
73798537|NCT02729909|147144807|SUPERIORITY||Median Value of CI|-0.3||||0.01|TWO_SIDED|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||-0.1|-0.5|0.010
73798538|NCT02729909|147144808|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|1.0||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||1.0|0.4|<0.001
73798539|NCT02729909|147144808|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|0.9||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||0.9|0.4|<0.001
73798540|NCT02729909|147144808|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|0.8||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||0.8|0.4|<0.001
73798541|NCT02729909|147144808|SUPERIORITY||Median Value of CI|0.5|||<|0.001|TWO_SIDED|95.0|0.2|0.7||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||0.7|0.2|<0.001
73798542|NCT02729909|147144809|SUPERIORITY||Median Value of CI|-0.5||||0.02|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||-0.1|-0.9|0.020
73798543|NCT02729909|147144809|SUPERIORITY|||||||0.072||||||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||||0.072
73798544|NCT02729909|147144809|SUPERIORITY||Median Value of CI|-0.5|||<|0.001|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||-0.1|-0.9|<0.001
73798545|NCT02729909|147144809|SUPERIORITY||Median Value of CI|-0.5||||0.004|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||-0.1|-0.9|0.004
73798546|NCT00866359|147144810|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.4|-0.9|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group and gender as factors and the baseline ulcer number as a covariate.|||-0.9|-2.4|<0.0001
73798547|NCT00866359|147144811|SUPERIORITY_OR_OTHER_LEGACY||Least Squares mean difference|-26.8|||<|0.0001|TWO_SIDED|95.0|-35.5|-18.0|||ANCOVA||Based on an analysis of covariance model for the oral ulcer pain VAS at Day 85, with treatment group and gender as factors and the baseline oral ulcer pain VAS as a covariate.|||-18.0|-35.5|<0.0001
73798548|NCT00866359|147144814|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-90.07|||<|0.0001|TWO_SIDED|95.0|-125.32|-54.82||The last post-baseline observation was carried forward to Day 85 for participants who discontinued the study before Day 85. For participants who did not have Day 85 visit on the targeted date, the total AUC was adjusted by the actual study days.|ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.|||-54.82|-125.32|<0.0001
73798549|NCT00866359|147144817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0007|TWO_SIDED|95.0|-2.7|-0.8|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.|||-0.8|-2.7|0.0007
73798550|NCT00866359|147144818|SUPERIORITY_OR_OTHER_LEGACY||adjusted difference (percentage)|39.1|||<|0.0001|TWO_SIDED|95.0|23.6|54.5|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test adjusting for gender.|Adjusted difference in proportions = weighted average of treatment differences across gender with the CMH weights.|||54.5|23.6|<0.0001
73798551|NCT00866359|147144819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0007|TWO_SIDED|95.0|-1.7|-0.5|||ANCOVA||Based on an Ancova model for change from baseline with treatment group, gender and interaction of treatment group and gender as factors and the baseline value as a covariate.|||-0.5|-1.7|0.0007
73798552|NCT03051672|147144834|SUPERIORITY|||||||||||||The study terminated at stage 1 and no p-value was estimated.||||The study uses a Simon 2-stage design. In stage 1, if \>/=1 of 8 achieved OR then continue to stage 2 (enroll 19 more). If \>/= 3 of 27 respond, the regimen would be considered promising. The null ORR\<= 3% and alternative ORR\>/=20%. With this design, the probability of stopping the trial early is 58% if the true ORR is 3%. This design at 80% power to declare the combination effective, while controlling for less than 5% 1-sided type I error under the null hypothesis.|The study terminated at stage 1 and no p-value was estimated.|||
73798553|NCT01459783|147144845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.76|TWO_SIDED|95.0|-5.13|6.95||We adopted Bonferroni adjustment for multiple testing and used a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, \& intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse burden for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.||6.95|-5.13|0.76
73798554|NCT01459783|147144846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.49|TWO_SIDED|95.0|-1.74|3.55||We used Bonferroni adjustment for multiple testing and a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes. The behavior measure is analyzed two ways: total number of problems (reported here), and reaction score.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, \& intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse problems for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.||3.55|-1.74|0.49
73798555|NCT01328184|147144851|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|102.82|STANDARD_DEVIATION|9.0|||TWO_SIDED|90.0|97.58|108.35|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||108.35|97.58|
73798556|NCT01328184|147144852|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|101.94|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|98.54|105.47|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||105.47|98.54|
73798557|NCT01328184|147144853|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|99.22|STANDARD_DEVIATION|10.4|||TWO_SIDED|90.0|93.4|105.39|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV).|No formal testing, investigation of relative bioavailability.||105.39|93.40|
73798558|NCT01328184|147144854|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|105.81|STANDARD_DEVIATION|10.7|||TWO_SIDED|90.0|99.47|112.55|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||112.55|99.47|
73798559|NCT04917861|147144887|OTHER||Geometric Mean Ratio (GMR)|7.002|||||TWO_SIDED|95.0|5.451|8.992|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||8.992|5.451|
73798560|NCT04917861|147144887|OTHER||GMR|7.123|||||TWO_SIDED|95.0|5.467|9.279|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||9.279|5.467|
73798561|NCT04917861|147144887|OTHER||GMR|2.674|||||TWO_SIDED|95.0|1.961|3.646|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||3.646|1.961|
73798562|NCT04917861|147144887|OTHER||GMR|7.208|||||TWO_SIDED|95.0|5.428|9.571|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||9.571|5.428|
73798563|NCT04917861|147144887|OTHER||GMR|7.979|||||TWO_SIDED|95.0|6.106|10.425|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||10.425|6.106|
73892785|NCT00505778|147318507|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.0||||0.977|TWO_SIDED|95.0|-4.6|4.7|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||4.7|-4.6|0.9770
73892786|NCT00505778|147318508|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.4726|TWO_SIDED|95.0|0.762|1.796|||Log Rank|Stratified by prior Asacol dose Category||||1.796|0.762|0.4726
73798564|NCT04917861|147144887|OTHER||GMR|1.516|||||TWO_SIDED|95.0|1.229|1.869|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||1.869|1.229|
73798565|NCT04917861|147144887|OTHER||GMR|6.785|||||TWO_SIDED|95.0|4.562|10.092|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||10.092|4.562|
73798566|NCT04917861|147144887|OTHER||GMR|6.319|||||TWO_SIDED|95.0|4.03|9.909|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||9.909|4.030|
73798567|NCT04917861|147144887|OTHER||GMR|7.028|||||TWO_SIDED|95.0|4.056|12.18|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||12.180|4.056|
73798568|NCT04917861|147144888|OTHER||GMR|5.312|||||TWO_SIDED|95.0|4.149|6.802|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||6.802|4.149|
73798569|NCT04917861|147144888|OTHER||GMR|5.346|||||TWO_SIDED|95.0|4.128|6.922|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||6.922|4.128|
73892787|NCT00505778|147318509|SUPERIORITY_OR_OTHER||Difference BID-QD in Least Square Mean|-0.45||||0.1753|TWO_SIDED|95.0|-1.09|0.2|||ANOVA|ANOVA with prior Asacol dose category as factor.||||0.20|-1.09|0.1753
73798570|NCT04917861|147144888|OTHER||GMR|2.325|||||TWO_SIDED|95.0|1.721|3.14|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||3.140|1.721|
73798571|NCT04917861|147144888|OTHER||GMR|4.221|||||TWO_SIDED|95.0|3.322|5.363|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||5.363|3.322|
73798572|NCT04917861|147144888|OTHER||GMR|5.3|||||TWO_SIDED|95.0|4.243|6.62|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||6.620|4.243|
73798573|NCT04917861|147144888|OTHER||GMR|1.206|||||TWO_SIDED|95.0|1.033|1.407|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||1.407|1.033|
73798574|NCT04917861|147144888|OTHER||GMR|6.493|||||TWO_SIDED|95.0|4.358|9.674|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||9.674|4.358|
73798575|NCT04917861|147144888|OTHER||GMR|5.452|||||TWO_SIDED|95.0|3.43|8.665|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||8.665|3.430|
73798576|NCT04917861|147144888|OTHER||GMR|6.804|||||TWO_SIDED|95.0|3.928|11.784|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||11.784|3.928|
73798577|NCT04917861|147144889|OTHER||percentage difference|76.69|||||TWO_SIDED|95.0|69.1|82.68|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||82.68|69.10|
73798578|NCT04917861|147144889|OTHER||percentage difference|77.8|||||TWO_SIDED|95.0|70.29|83.67|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||83.67|70.29|
73798579|NCT04917861|147144889|OTHER||percentage difference|35.58|||||TWO_SIDED|95.0|27.47|43.74|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||43.74|27.47|
73892788|NCT00505778|147318510|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|Difference BID-QD Remission Rates|3.6||||0.1557|TWO_SIDED|95.0|-1.3|8.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||8.5|-1.3|0.1557
73892789|NCT05367492|147318512|SUPERIORITY||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|3.0|14.1|||Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||14.1|3.0|<0.001
73798580|NCT04917861|147144889|OTHER||percentage difference|86.11|||||TWO_SIDED|95.0|76.25|92.29|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||92.29|76.25|
73798581|NCT04917861|147144889|OTHER||percentage difference|87.65|||||TWO_SIDED|95.0|78.71|93.17|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||93.17|78.71|
73798582|NCT04917861|147144889|OTHER||percentage difference|20.43|||||TWO_SIDED|95.0|13.47|29.75|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||29.75|13.47|
73798583|NCT04917861|147144889|OTHER||percentage difference|67.72|||||TWO_SIDED|95.0|55.69|77.07|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||77.07|55.69|
73798584|NCT04917861|147144889|OTHER||percentage difference|67.81|||||TWO_SIDED|95.0|55.36|77.44|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||77.44|55.36|
73798585|NCT04917861|147144889|OTHER||percentage difference|57.53|||||TWO_SIDED|95.0|43.81|69.08|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||69.08|43.81|
73798586|NCT04917861|147144890|OTHER||percentage difference|75.46|||||TWO_SIDED|95.0|68.12|81.49|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||81.49|68.12|
73798587|NCT04917861|147144890|OTHER||percentage difference|75.32|||||TWO_SIDED|95.0|67.94|81.38|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||81.38|67.94|
73798588|NCT04917861|147144890|OTHER||percentage difference|31.29|||||TWO_SIDED|95.0|24.23|38.96|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||38.96|24.23|
73798589|NCT04917861|147144890|OTHER||percentage difference|77.78|||||TWO_SIDED|95.0|66.87|85.85|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||85.85|66.87|
73798590|NCT04917861|147144890|OTHER||percentage difference|82.72|||||TWO_SIDED|95.0|73.02|89.43|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||89.43|73.02|
73798591|NCT04917861|147144890|OTHER||percentage difference|9.68|||||TWO_SIDED|95.0|4.63|17.41|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||17.41|4.63|
73798592|NCT04917861|147144890|OTHER||percentage difference|72.39|||||TWO_SIDED|95.0|61.56|80.83|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||80.83|61.56|
73798593|NCT04917861|147144890|OTHER||percentage difference|67.29|||||TWO_SIDED|95.0|55.72|76.78|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||76.78|55.72|
73798594|NCT04917861|147144890|OTHER||percentage difference|63.35|||||TWO_SIDED|95.0|50.75|74.0|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||74.00|50.75|
73798595|NCT06389487|147144904|NON_INFERIORITY|Non-Inferiority (NI) was to be demonstrated if the upper limit of the 95% confidence interval (CI) of the group GMT ratio between Part A:RSV-OA Group over Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was less than or equal to (≤) 1.5.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||The comparison is done using the group ratio of adjusted GMT (Part A:RSV-OA/ Part A:RSV-A-AIR) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.||0.81|0.64|
73798596|NCT06389487|147144905|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group SRR difference between Part A:RSV-OA Group and Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤10%.|Difference in percentage|-9.33|||||TWO_SIDED|95.0|-14.55|-4.1|||||The comparison is done using the difference of SRR (Part A:RSV-OA - Part A:RSV-A-AIR).|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.||-4.10|-14.55|
73798597|NCT06389487|147144906|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group GMT ratio between Part A:RSV-OA Group over Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤1.5.|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.65|0.82|||||The comparison is done using the group ratio of adjusted GMT (Part A:RSV-OA/ Part A:RSV-A-AIR) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.||0.82|0.65|
73798598|NCT06389487|147144907|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group SRR difference between Part A:RSV-OA Group and Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤10%.|Difference in percentage|-10.03|||||TWO_SIDED|95.0|-15.26|-4.8|||||The comparison is done using the difference of SRR (Part A:RSV-OA - Part A:RSV-A-AIR).|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.||-4.80|-15.26|
73798599|NCT05351164|147144925|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
73798600|NCT05351164|147144926|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73798601|NCT03493685|147144927|OTHER||Slope difference|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.7491|TWO_SIDED|95.0|-1.74|2.41|||Mixed Models Analysis|||||2.41|-1.74|0.7491
73798602|NCT03493685|147144928|OTHER||Risk Difference (RD)|16.0||||0.0094|TWO_SIDED|95.0|3.96|28.04|||Mixed Models Analysis|||||28.04|3.96|0.0094
73798603|NCT03493685|147144929|OTHER||Slope difference|0.9|STANDARD_ERROR_OF_MEAN|1.09||0.4203|TWO_SIDED|95.0|-1.27|3.04|||Mixed Models Analysis|||||3.04|-1.27|0.4203
73798604|NCT03493685|147144930|OTHER||Mean Difference (Final Values)|1.8||||0.2708|TWO_SIDED|95.0|-1.39|4.93|||ANCOVA|||||4.93|-1.39|0.2708
73798605|NCT03300817|147144936|SUPERIORITY|||||||0.6834|||||||Wilcoxon Rank-Sum test|||||||0.6834
73798606|NCT03713593|147144967|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.834|||||TWO_SIDED|95.0|0.712|0.978|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.978|0.712|
73798607|NCT03713593|147144968|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0227|TWO_SIDED|95.0|0.708|0.997|||Log Rank|Onesided p-value based on logrank test stratified by geographic region, portal vein invasion/extrahepatic spread/both AFP status,ECOG status.|Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.997|0.708|0.0227
73798608|NCT03713593|147144969|OTHER|Descriptive assessment|Difference in percentage|8.5|||||TWO_SIDED|95.0|2.8|14.2|||||Based on Miettinen \& Nurminen method stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||14.2|2.8|
73798609|NCT03713593|147144972|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.93|0.66|
73798610|NCT03713593|147144973|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.68|0.94|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.94|0.68|
73798611|NCT03713593|147144974|OTHER|Descriptive assessment|Difference in percentage|6.7|||||TWO_SIDED|95.0|0.0|13.4|||||Based on Miettinen \& Nurminen method stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||13.4|0.0|
73798612|NCT03713593|147144977|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.61|0.88|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.88|0.61|
73798613|NCT04653454|147144984|SUPERIORITY|||||||0.129||||||Hypoglycemic Episodes \<54 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.129
73798614|NCT04653454|147144984|SUPERIORITY|||||||0.008||||||Hypoglycemic Episodes \<70 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.008
73798615|NCT04653454|147144985|SUPERIORITY|||||||0.203||||||Hypoglycemic Episodes \<54 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.203
73798616|NCT04653454|147144985|SUPERIORITY||||||<|0.001||||||Hypoglycemic Episodes \<70 mg/dL|Wilcoxon (Mann-Whitney)|||||||<0.001
73798617|NCT04653454|147144987|SUPERIORITY|||||||0.076||||||Hyperglycemic Episodes \>180 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.076
73798618|NCT04653454|147144987|SUPERIORITY|||||||0.038||||||Hyperglycemic Episodes \>250 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.038
73798619|NCT04653454|147144988|SUPERIORITY||||||<|0.0001||||||Creatinine|Spearman Correlation coefficients|||||||<0.0001
73798620|NCT04653454|147144988|SUPERIORITY|||||||0.0002||||||139GFR|Spearman Correlation coefficients|||||||0.0002
73798621|NCT04653454|147144988|SUPERIORITY|||||||0.22||||||Bicarbonate|Spearman Correlation coefficients|||||||0.22
73798622|NCT04653454|147144988|SUPERIORITY|||||||0.48||||||Hemoglobin|Spearman Correlation coefficients|||||||0.48
73798623|NCT04653454|147144988|SUPERIORITY|||||||0.77||||||MAP|Spearman Correlation coefficients|||||||0.77
73798624|NCT04653454|147144988|SUPERIORITY|||||||0.0516||||||SpO2|Spearman Correlation coefficients|||||||0.0516
73798625|NCT03620708|147144993|SUPERIORITY||chi-square|3.492|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73798626|NCT03620708|147144994|SUPERIORITY||chi-square|4.36||||0.113|TWO_SIDED||||||Chi-squared|||||||.113
73798627|NCT03620708|147144995|SUPERIORITY||Mean Difference (Final Values)|3.661||||0.032|TWO_SIDED||||||ANOVA|||||||.032
73798628|NCT03620708|147144996|SUPERIORITY||Mean Difference (Final Values)|1.543||||0.227|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of confidence in ability to quit.||||.227
73798629|NCT03620708|147144996|SUPERIORITY||Mean Difference (Final Values)|0.338||||0.715|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported importance of quitting smoking.||||.715
73798630|NCT03620708|147144996|SUPERIORITY||Mean Difference (Final Values)|1.712||||0.19|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported readiness to quit smoking.||||.190
73798631|NCT03620708|147144997|SUPERIORITY||Mean Difference (Final Values)|1.728||||0.188|TWO_SIDED||||||ANOVA|||||||.188
73798632|NCT04479852|147145038|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.133|TWO_SIDED|95.0|-4.1|0.5|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||0.5|-4.1|0.133
73798633|NCT04479852|147145039|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.059|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||0.0|-0.5|0.059
73798634|NCT04479852|147145040|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.159|TWO_SIDED|95.0|-2.7|0.4|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in HAM-D score from baseline.|||0.4|-2.7|0.159
73798635|NCT04479852|147145041|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.188|TWO_SIDED|95.0|-2.5|0.5|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in SDS score from baseline.|||0.5|-2.5|0.188
73798636|NCT04479852|147145042|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.091|TWO_SIDED|95.0|-2.0|0.2|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in QIDS score from baseline.|||0.2|-2.0|0.091
73798637|NCT04479852|147145043|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.243|TWO_SIDED|95.0|-1.2|4.6|||Mixed Models Analysis||A positive difference favors the SP-624 treatment group, i.e., a greater increase in Q-LES-Q score from baseline.|||4.6|-1.2|0.243
73798638|NCT04479852|147145044|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.008|TWO_SIDED|95.0|-6.8|-1.0|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||-1.0|-6.8|.008
73798639|NCT04479852|147145045|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.8|-0.1|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||-0.1|-0.8|0.006
73798640|NCT04479852|147145046|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.134|TWO_SIDED|95.0|-0.8|6.3|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||6.3|-0.8|0.134
73798641|NCT04479852|147145047|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.437|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||0.6|-0.3|0.437
73798642|NCT02366689|147145072|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.04
73798643|NCT02366689|147145073|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||< 0.001
73798644|NCT02366689|147145074|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
73798645|NCT02366689|147145075|SUPERIORITY_OR_OTHER|||||||0.432|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.432
73798646|NCT02366689|147145076|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
73798647|NCT02366689|147145077|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
73798648|NCT03283566|147145079|EQUIVALENCE|Assuming a 20-30% difference in outcome (CP/G quotient) between study arms, which is equivalent to 0.08-0.12 CP/G difference and a 0.07 standard deviation, a sample size of 6 subjects (1:1 randomization) will detect a CP/G difference of at least 0.12, assuming 80% power, with a 0.05 significance level.||||||0.739|||||||ANOVA|||||||0.739
73798649|NCT03288714|147145082|SUPERIORITY|||||||0.814|||||||Fisher Exact|The proportion of patients is compared across treatment groups using Fisher's Exact.||Null hypothesis is that the active sTMS treatment group does not differ from the sham group with respect to the proportion of patients with clinical response at Week 6.||||.814
73798650|NCT03288714|147145083|SUPERIORITY|||||||0.872|||||||ANCOVA|P-value is from analysis of covariance adjusting for baseline.||Null hypothesis is that the active sTMS treatment group does not differ from the sham group with respect to the proportion of patients with clinical response at Week 6.||||.872
73798651|NCT03288714|147145084|SUPERIORITY|||||||0.641|||||||ANCOVA|P-value is from analysis of covariance adjusting for baseline.||The null hypothesis is that the active sTMS treatment group does not differ||||.641
73798652|NCT03288714|147145085|SUPERIORITY|||||||0.032||||||Alpha level: .05|ANCOVA|P-value is from analysis of covariance adjusting for baseline||||||.032
73798653|NCT03288714|147145086|SUPERIORITY|||||||0.015||||||Alpha level: .05|ANCOVA|P-value is from analysis of covariance adjusting for baseline||||||.015
73798654|NCT03288714|147145087|SUPERIORITY|||||||0.028||||||Alpha level: .05|Fisher Exact|The proportion of patients is compared across treatment groups using Fisher's Exact.||||||.028
73798655|NCT04882241|147145100|OTHER||Hazard Ratio (HR)|0.92||||0.39528|TWO_SIDED|95.0|0.5|1.7||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.70|0.50|0.39528
73798656|NCT04882241|147145101|OTHER||Difference in Percentage|1.9||||0.33244|TWO_SIDED|95.0|-7.7|12.0|||Miettinen and Nurminen|Based on unstratified Miettinen \& Nurminen method||||12.0|-7.7|0.33244
73798657|NCT04882241|147145102|OTHER||Hazard Ratio (HR)|1.03||||0.52903|TWO_SIDED|95.0|0.48|2.22||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.22|0.48|0.52903
73798658|NCT04882241|147145107|OTHER||Hazard Ratio (HR)|0.83||||0.34632|TWO_SIDED|95.0|0.34|2.05||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.05|0.34|0.34632
73798659|NCT02543944|147145118|SUPERIORITY||Risk Ratio (RR)|-0.0944|STANDARD_ERROR_OF_MEAN|0.32||0.77|TWO_SIDED|95.0|-0.72|0.53|||Regression, Logistic|||||0.53|-0.72|0.77
73798660|NCT02543944|147145119|SUPERIORITY||Odds Ratio (OR)|0.3||||0.58|TWO_SIDED||||||Chi-squared|||||||0.58
73798661|NCT02543944|147145120|SUPERIORITY||Odds Ratio (OR)|0.16||||0.69|TWO_SIDED||||||Chi-squared|||||||0.69
73798662|NCT02543944|147145121|SUPERIORITY||Odds Ratio (OR)|0.96||||0.32|TWO_SIDED||||||Chi-squared|||||||0.32
73798663|NCT05262387|147145131|OTHER||Mean Difference (Final Values)|9.32||||0.0494|TWO_SIDED|90.0|1.52|17.1|||Mixed Models Analysis|||||17.1|1.52|0.0494
73798664|NCT05262387|147145131|OTHER||Mean Difference (Final Values)|14.1||||0.0028|TWO_SIDED|90.0|6.38|21.9|||Mixed Models Analysis|||||21.9|6.38|0.0028
73798665|NCT05262387|147145132|OTHER||Mean Difference (Final Values)|-44.5||||0.1998|TWO_SIDED|90.0|-102.0|12.8|||Mixed Models Analysis|||||12.8|-102|0.1998
73798666|NCT05262387|147145132|OTHER||Mean Difference (Final Values)|4.16||||0.9041|TWO_SIDED|90.0|-53.1|61.4|||Mixed Models Analysis|||||61.4|-53.1|0.9041
73798667|NCT02515331|147145135|SUPERIORITY||Mean Difference (Net)|-8.555|STANDARD_ERROR_OF_MEAN|2.9077||0.002|TWO_SIDED|95.0|-14.388|-2.722||1-sided p-value|Longitudinal repeated measures mixed eff|||||-2.722|-14.388|0.002
73798668|NCT02515331|147145135|SUPERIORITY||Mean Difference (Net)|-14.727|STANDARD_ERROR_OF_MEAN|3.0548|<|0.001|TWO_SIDED|95.0|-20.852|-8.602||1-sided p-value|Longitudinal repeated measures mixed eff|||||-8.602|-20.852|<0.001
73798669|NCT01269918|147145176|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority delta of 7.5 mmHg. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-13.0|-5.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.||-5|-13|< 0.001
73798670|NCT01269918|147145176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|97.5|-13.0|-4.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.||-4|-13|< 0.001
73798671|NCT01269918|147145177|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority delta of 1 point. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.||-1.1|-2.7|< 0.001
73798672|NCT01269918|147145177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|97.5|-2.8|-0.9|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.||-0.9|-2.8|< 0.001
73798673|NCT01269918|147145178|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority delta = 2 mg opioid|Median Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test||-5|-10|< 0.001
73798674|NCT01269918|147145178|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|97.5|-10.0|-3.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test||-3|-10|< 0.001
73798675|NCT01269918|147145179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-10.0|3.0|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on heart rate was assessed using a linear mixed effects model adjusting for baseline heart rate.||3|-10|< 0.001
73798676|NCT01269918|147145180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.16|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on SOMCT estimated using a linear mixed effects model adjusting for baseline SOMCT score.||0.5|-2.6|0.16
73798677|NCT01269918|147145181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.6|0.03|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on Aldrete score estimated using a linear mixed effects model adjusting for baseline Aldrete score.||0.03|-0.6|0.07
73892790|NCT05367492|147318512|SUPERIORITY||||||<|0.001||||||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the primary outcome measure. Effects were deemed significant for p\<0.05.|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
73892791|NCT05367492|147318513|SUPERIORITY||Odds Ratio (OR)|6.1|||<|0.001|TWO_SIDED|95.0|3.1|12.3||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||12.3|3.1|<0.001
73798678|NCT01269918|147145182|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.009|TWO_SIDED|95.0|-1.0|-0.001|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on Nursing workload comparison estimated using a Wilcoxon rank sum test.||-0.001|-1|0.009
73798679|NCT01269918|147145183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11|||<|0.001|TWO_SIDED|95.0|0.07|0.18|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to open eyes estimated using Cox regression.||0.18|0.07|< 0.001
73798680|NCT01269918|147145184|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.12|||<|0.001|TWO_SIDED|95.0|0.07|0.19|||Regression, Cox|||Remifentanyl versus dexmedetomidine on time to recall assessed using Cox regression.||0.19|0.07|< 0.001
73798681|NCT01269918|147145185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.022|TWO_SIDED|95.0|0.48|0.95|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to fitness discharge estimated using Cox regression.||0.95|0.48|0.022
73798682|NCT01269918|147145186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.45|TWO_SIDED|95.0|0.81|1.62|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to PACU discharge estimated using Cox proportional hazard regression||1.62|0.81|0.45
73798683|NCT01269918|147145187|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.91|TWO_SIDED|95.0|0.5|2.2|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative nausea estimated from chi squared test.||2.2|0.5|0.91
73798684|NCT01269918|147145188|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.16|TWO_SIDED|95.0|0.07|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative vomiting estimated from a chi square test.||1.7|0.07|0.16
73798685|NCT01269918|147145189|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.21|TWO_SIDED|95.0|0.1|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on incidence of shivering estimated from a chi square test.||1.7|0.1|0.21
73798686|NCT04471428|147145209|SUPERIORITY|Stratified Analysis: Stratification factors include histology, and prior NSCLC treatment regimens|Hazard Ratio (HR)|0.884||||0.3668|TWO_SIDED|95.0|0.676|1.156|||Log Rank||Hazard ratio was estimated by Cox regression model.|||1.156|0.676|0.3668
73798687|NCT04471428|147145209|SUPERIORITY||Hazard Ratio (HR)|0.907||||0.4709|TWO_SIDED|95.0|0.696|1.182|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.182|0.696|0.4709
73798688|NCT04471428|147145210|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0079|TWO_SIDED|95.0|0.585|0.923|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors include histology, and prior NSCLC treatment regimens||0.923|0.585|0.0079
73798689|NCT04471428|147145210|SUPERIORITY||Hazard Ratio (HR)|0.731||||0.0061|TWO_SIDED|95.0|0.583|0.915|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified analysis||0.915|0.583|0.0061
73798690|NCT04471428|147145211|SUPERIORITY||Difference in Response Rates|-1.51||||0.6846|TWO_SIDED|95.0|-8.85|5.84|||Cochran-Mantel-Haenszel||95% CIs was computed using the Wald method.|Stratified analysis; stratification factors- histology, prior NSCLC treatment regimens||5.84|-8.85|0.6846
73798691|NCT04471428|147145211|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.47|1.63|||||Odds ratios were estimated by logistic regression. 95% CIs was computed using the Wald method.|Stratified analysis; stratification factors- histology, prior NSCLC treatment regimens||1.63|0.47|
73798692|NCT04471428|147145211|SUPERIORITY||Difference in Response Rates|-1.51||||0.7216|TWO_SIDED|95.0|-8.85|5.84|||Chi-squared, Corrected||95% CIs was computed using the Wald method.|Unstratified Analysis||5.84|-8.85|0.7216
73798693|NCT04471428|147145211|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.47|1.62|||||Odds ratios were estimated by logistic regression. 95% CIs was computed using the Wald method.|Unstratified Analysis||1.62|0.47|
73798694|NCT04471428|147145213|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.27|TWO_SIDED|95.0|0.59|1.16|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis: Stratification factors include histology, and prior NSCLC treatment regimens||1.16|0.59|0.2700
73892792|NCT05367492|147318513|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
73798695|NCT04471428|147145213|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3031|TWO_SIDED|95.0|0.6|1.17|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.17|0.60|0.3031
73798696|NCT04471428|147145214|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.2408|TWO_SIDED|95.0|0.86|1.79|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratification factors include histology, and prior NSCLC treatment regimens||1.79|0.86|0.2408
73798697|NCT04471428|147145214|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.1992|TWO_SIDED|95.0|0.88|1.81|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.81|0.88|0.1992
73798698|NCT04471428|147145215|SUPERIORITY||Difference in Event Free Rate|15.85||||0.0014|TWO_SIDED|95.0|6.12|25.59|||z-test||The 95% CI for the difference in PFS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 6 months||25.59|6.12|0.0014
73798699|NCT04471428|147145215|SUPERIORITY||Difference in Event Free Rate|6.32||||0.0719|TWO_SIDED|95.0|-0.56|13.21|||z-test||The 95% CI for the difference in PFS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 1 year||13.21|-0.56|0.0719
73798700|NCT04471428|147145216|SUPERIORITY||Difference in Event Free Rate|-0.85||||0.8767|TWO_SIDED|95.0|-11.63|9.92|||z-test||The 95% CI for the difference in OS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 1 year||9.92|-11.63|0.8767
73892793|NCT05367492|147318514|SUPERIORITY||Odds Ratio (OR)|6.0||||0.001|TWO_SIDED|95.0|2.1|16.9||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||16.9|2.1|0.001
73798701|NCT00129545|147145228|NON_INFERIORITY_OR_EQUIVALENCE|The posterior probability of non-inferiority is defined as the probability that the event rate for the Device group is less than twice that for the Control group. This probability was required to be greater than 0.975 for a finding of non-inferiority. The criterion for non-inferiority was consistently met at each analysis time point demonstrating the Device group is non-inferior to the Control group.|Risk Ratio (RR)|0.61|||||TWO_SIDED|95.0|0.42|1.07|||||Relative Risk calculated as Device Rate over Control rate, with 95% Credible Intervals|||1.07|0.42|
73798702|NCT01870778|147145243|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.3857|TWO_SIDED|95.0|0.83|1.15||Adjusted alpha p-value based on multiple testing procedure.|Log Rank|One-sided p-value||||1.15|0.83|0.3857
73798703|NCT01870778|147145244|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0968|TWO_SIDED|95.0|0.75|1.07||Adjusted p-value based on multiple testing procedure|Gehan's generalized Wilcoxon test|One-sided p-value||||1.07|0.75|0.0968
73798704|NCT01870778|147145245|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.389|TWO_SIDED|95.0|0.81|1.08|||Log Rank|2-sided p-value||||1.08|0.81|0.3890
73798705|NCT01870778|147145246|SUPERIORITY|||||||0.2204||||||Based on multiple testing procedure|Wilcoxon rank sum test|One-sided p-value||||||0.2204
73798706|NCT01870778|147145247|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.2744|TWO_SIDED|95.0|0.88|1.07||Adjusted p-value based on multiple testing procedure|Log Rank|||||1.07|0.88|0.2744
73798707|NCT01870778|147145248|SUPERIORITY|||||||0.2103|||||||Wilcoxon rank sum test|2-sided p-value||||||0.2103
73798708|NCT01870778|147145249|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.005|TWO_SIDED|95.0|1.02|1.14|||Log Rank|2-sided p-value||Exertional dyspnea||1.14|1.02|0.0050
73798709|NCT01870778|147145249|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.0051|TWO_SIDED|95.0|1.02|1.14|||Log Rank|2-sided p-value||Orthopnea||1.14|1.02|0.0051
73798710|NCT01870778|147145249|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9962|TWO_SIDED|95.0|0.95|1.05|||Log Rank|2-sided p-value||Rales||1.05|0.95|0.9962
73798711|NCT01870778|147145249|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.0196|TWO_SIDED|95.0|1.01|1.15|||Log Rank|2-sided p-value||Jugular venous pressure||1.15|1.01|0.0196
73798712|NCT01870778|147145249|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.2158|TWO_SIDED|95.0|0.98|1.1|||Log Rank|2-sided p-value||Peripheral edema, pre-sacral edema||1.10|0.98|0.2158
73798713|NCT01870778|147145250|SUPERIORITY||Ratio of RLX030 to placebo|0.9401||||0.0209|TWO_SIDED|95.0|0.8921|0.9907|||Repeated measures model|||Day 2||0.9907|0.8921|0.0209
73798714|NCT01870778|147145250|SUPERIORITY||Ratio of RLX030 to placebo|0.898||||0.0034|TWO_SIDED|95.0|0.8358|0.9649|||Repeated measures model|||Day 5||0.9649|0.8358|0.0034
73798715|NCT01870778|147145250|SUPERIORITY||Ratio of RLX030 to placebo|0.9074||||0.0209|TWO_SIDED|95.0|0.8355|0.9854|||Repeated measures model|||Day 14||0.9854|0.8355|0.0209
73798716|NCT01870778|147145251|SUPERIORITY||Ratio of RLX030 to placebo|0.8597||||0.0007|TWO_SIDED|95.0|0.7876|0.9385|||Repeated measures model|||Day 2||0.9385|0.7876|0.0007
73798717|NCT01870778|147145251|SUPERIORITY||Ratio of RLX030 to placebo|0.9539||||0.3709|TWO_SIDED|95.0|0.86|1.0579|||Repeated measures model|||Day 5||1.0579|0.8600|0.3709
73798718|NCT01870778|147145251|SUPERIORITY||Ratio of RLX030 to placebo|0.9543||||0.3893|TWO_SIDED|95.0|0.8578|1.0617|||Repeated measures model|||Day 14||1.0617|0.8578|0.3893
73798719|NCT01870778|147145252|SUPERIORITY||Ratio of RLX030 to placebo|0.9637||||0.0003|TWO_SIDED|95.0|0.9447|0.983|||Repeated measures model|||Day 2||0.9830|0.9447|0.0003
73798720|NCT01870778|147145252|SUPERIORITY||Ratio of RLX030 to placebo|0.9922||||0.5361|TWO_SIDED|95.0|0.9677|1.0172|||Repeated measures model|||Day 5||1.0172|0.9677|0.5361
73798721|NCT01870778|147145252|SUPERIORITY||Ratio of RLX030 to placebo|0.9863||||0.375|TWO_SIDED|95.0|0.9567|1.0169|||Repeated measures model|||Day 14||1.0169|0.9567|0.3750
73798722|NCT00262028|147145256|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower limit (LL) of the 95% confidence intervals (CI) of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|37.0|||||TWO_SIDED|95.0|29.0|44.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A||44|29|
73798723|NCT00262028|147145256|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.0|26.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C||26|12|
73798724|NCT00262028|147145256|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|23.0|||||TWO_SIDED|95.0|17.0|29.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W||29|17|
73798725|NCT00262028|147145256|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|31.0|||||TWO_SIDED|95.0|25.0|38.0||||||No inferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y||38|25|
73798726|NCT00262028|147145256|SUPERIORITY_OR_OTHER||Vaccine group difference|37.0|||||TWO_SIDED|95.0|29.0|44.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||44|29|
73892794|NCT05367492|147318514|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
73892795|NCT05367492|147318515|SUPERIORITY||Mean Difference (Net)|-1.88||||0.001|TWO_SIDED|95.0|-2.93|-0.83||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-0.83|-2.93|0.001
73892796|NCT05367492|147318515|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study group.||||||<0.001
73798727|NCT00262028|147145256|SUPERIORITY_OR_OTHER||Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.0|26.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||26|12|
73798728|NCT00262028|147145256|SUPERIORITY_OR_OTHER||Vaccine group difference|23.0|||||TWO_SIDED|95.0|17.0|29.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||29|17|
73798729|NCT00262028|147145256|SUPERIORITY_OR_OTHER||Vaccine group difference|31.0|||||TWO_SIDED|95.0|25.0|38.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||38|25|
73798730|NCT05724589|147145288|SUPERIORITY|A repeated measures ANOVA was selected to analyze changes in skin hydration across four time points within the same participants..|Mean Difference (Final Values)|2.671||||1|TWO_SIDED|||||The p-value reflects the overall test for difference in hydration over time and is not adjusted for multiple comparisons. The pre-defined threshold for statistical significance was p \< 0.05.|ANOVA|No additional adjustments were applied. Degrees of freedom and sphericity assumptions were checked.|The mean difference was calculated based on changes in skin hydration from baseline to Week 16 using repeated measures ANOVA, in accordance with the pre-specified statistical analysis plan.|Skin hydration was evaluated longitudinally using repeated measures ANOVA at Baseline, Week 8, Week 12, and Week 16. This pre-specified statistical test assessed within-subject changes over time to determine the efficacy of the serum.|The overall p-value corresponds to the repeated measures ANOVA evaluating changes over four time points. No multiplicity adjustments were applied.|||1.000
73798731|NCT05724589|147145289|SUPERIORITY|The statistical analysis in this study to assess changes in Transepidermal Water Loss (TEWL) after serum application involved a repeated measures analysis of variance (ANOVA). This approach allows for the examination of differences in TEWL across multiple time points (baseline, 8 weeks, 12 weeks, and 16 weeks) within the same individuals. The use of repeated measures ANOVA accounts for the correlated nature of the data, as multiple measurements are obtained from each participant over time.|Mean Difference (Final Values)|-3.656||||0.096|TWO_SIDED|||||A repeated measures ANOVA was used to assess changes in hydration over time. The mean difference between baseline and 16 weeks was -3.656 (arbitrary units). Results are presented in the corresponding outcome measure table.|ANOVA|||||||0.096
73798732|NCT05724589|147145290|SUPERIORITY|The chosen test was designed to assess whether application of the intervention resulted in any statistically significant differences over time in the primary outcome measure, assuming superiority.|Mean Difference (Final Values)|-0.043||||0.169|TWO_SIDED|||||The pre-specified significance threshold was set at p \< 0.05. No adjustments for multiple comparisons were applied.|ANOVA|Sphericity tested; Greenhouse-Geisser applied if needed. Repeated measures ANOVA accounted for within-subject correlations.|The estimation parameter reflects the change in the R2 elasticity measure from baseline to 16 weeks. The direction of change is based on the final minus baseline value, with baseline serving as the reference point.|The statistical analysis utilized repeated measures ANOVA to evaluate changes in facial skin elasticity (R2 parameter) across multiple time points (Baseline, Week 8, Week 12, and Week 16) within the same participants. This approach accounts for the correlation of repeated measures over time.||||0.169
73892797|NCT05367492|147318516|SUPERIORITY||Mean Difference (Net)|-6.76|||<|0.001|TWO_SIDED|95.0|-9.08|-4.45||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-4.45|-9.08|<0.001
73892798|NCT05367492|147318516|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus tests of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups.||||||<0.001
73892799|NCT05367492|147318517|SUPERIORITY||Mean Difference (Net)|-1.78||||0.008|TWO_SIDED|95.0|-3.08|-0.48||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-0.48|-3.08|0.008
73798733|NCT05724589|147145291|SUPERIORITY|This study aimed to evaluate changes in wrinkle scores using a 4-grade percentage wrinkle improvement scale across different time points, including baseline, 8 weeks, 12 weeks, and 16 weeks|Mean Difference (Final Values)|1.0||||1|TWO_SIDED||||||ANOVA||The Mean Difference represents the change in wrinkle scores from baseline (Day 0) to follow-up at Week 8, Week 12, or Week 16. For example, a Mean Difference of 1.0 indicates a 1-point improvement from baseline to Week 16 (Week 16 - baseline score).|||||1.000
73798734|NCT05724589|147145292|SUPERIORITY|Repeated measures ANOVA was used to detect any change in facial melanin levels due to the intervention.|Mean Difference (Final Values)|-3.458||||1|TWO_SIDED|||||The p-value indicates no statistically significant change in facial melanin index over time. The p-value was not adjusted for multiple comparisons. Statistical significance was pre-specified at p \< 0.05.|ANOVA|Sphericity assumptions were checked and addressed as needed (e.g., Greenhouse-Geisser correction).|The estimation parameter reflects the mean change in melanin index from baseline to week 16. Baseline was used as the reference point in the analysis.|The statistical analysis assessed changes in facial melanin index after serum application using repeated measures ANOVA. This method evaluated differences across multiple time points (Baseline, Week 8, Week 12, and Week 16) within the same participants, accounting for the correlated nature of repeated measures.||||1.000
73798735|NCT05724589|147145293|SUPERIORITY|A descriptive analysis was performed. No hypothesis testing or power calculation was conducted for this outcome.|percentage of participants at week 16|44.0||||1|TWO_SIDED|||||The p-value reflects descriptive analysis of SGAIS improvement scores; no statistical testing for significance was conducted.|Descriptive|The evaluation involved categorical SGAIS ratings assigned by two independent dermatologists.|This estimate reflects the proportion of participants rated as showing mild improvement on the SGAIS at Week 16, as detailed in the tabular data.|Improvement in facial appearance was assessed using the Subject Global Aesthetic Improvement Scale (SGAIS), rated independently by two board-certified dermatologists at multiple time points (8, 12, and 16 weeks).||||1.000
73798736|NCT05724589|147145294|SUPERIORITY|Descriptive summary statistics were used to report satisfaction at multiple time points. No inferential testing was performed.|percentage of participants at week 16|75.0|||||TWO_SIDED||||||Descriptive|No formal statistical hypothesis testing was performed.|The estimated percentage reflects participants who reported a satisfaction score of 2 or 3 at week 16.|"Satisfaction was assessed at weeks 8, 12, and 16 using a quartile scale:~0 = Unsatisfied, 1 = Slightly satisfied, 2 = Satisfied, 3 = Very satisfied. One participant was lost to follow-up after week 12."||||
73798737|NCT05724589|147145295|SUPERIORITY|This was a descriptive safety analysis. No inferential hypothesis testing was conducted.|Percentage adverse events by week 16|0.0|||||TWO_SIDED||||||Descriptive|No formal statistical test was conducted.|Descriptive summaries of adverse event incidence are reported in the results tables.|The analysis population includes 28 participants. One subject was lost to follow-up at week 12. Adverse events were assessed through video calls at weeks 2 and 4, and in-person visits at 2, 3, and 4 months.||||
73798738|NCT02273388|147145322|OTHER||Difference of adjusted means|-4.56|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-10.59|1.48|||||Comparison vs. 1 hour infusion \[2h-1h\]|Change from baseline to 5 minutes before infusion end. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||1.48|-10.59|
73798739|NCT02273388|147145322|OTHER||Difference of adjusted means|-7.14|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-13.18|-1.11|||||Comparison vs. 1hour infusion \[2h-1h\]|Change from baseline to 1 hour after infusion end. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||-1.11|-13.18|
73798740|NCT02273388|147145322|OTHER||Difference of adjusted means|-3.58|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-9.61|2.46|||||Comparison vs. 1 hour infusion \[2h-1h\]|Change from baseline to 4 hours after infusion start. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||2.46|-9.61|
73798741|NCT02273388|147145322|OTHER||Difference of adjusted means|-8.66|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-14.7|-2.63|||||Comparison vs. 1 hour \[2h-1h\]|Change from baseline to 24 hours after infusion start. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||-2.63|-14.70|
73798742|NCT04331808|147145346|SUPERIORITY||Median posterior absolute risk differenc|-9.0|||||TWO_SIDED|90.0|-21.0|3.1||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credibility interval here|||3.1|-21.0|
73798743|NCT04331808|147145347|SUPERIORITY||Median posterior Hazard Ratio|0.58|||||TWO_SIDED|90.0|0.33|1.0||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible Interval here|||1.00|0.33|
73798744|NCT04331808|147145348|SUPERIORITY||Median posterior absolute risk differenc|1.7|||||TWO_SIDED|90.0|-13.6|17.1||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credible Interval here Results are presented as the proportion not improved, so that an effective treatment would be associated with a decrease in proportion.|||17.1|-13.6|
73798745|NCT04331808|147145349|SUPERIORITY||Median posterior Hazard Ratio|1.19|||||TWO_SIDED|90.0|0.71|2.04||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible Interval here|||2.04|0.71|
73798746|NCT04331808|147145350|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.4|3.55|||Regression, Cox|adjusted for age and sex||Day 14||3.55|0.40|
73798747|NCT04331808|147145350|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.33|2.53|||Regression, Cox|adjusted for age and centre||Day 28||2.53|0.33|
73798748|NCT04331808|147145350|SUPERIORITY||Cox Proportional Hazard|0.64|||||TWO_SIDED|95.0|0.25|1.65|||Regression, Cox|adjusted for age and centre||Day 90||1.65|0.25|
73798749|NCT04331808|147145350|SUPERIORITY||Hazard Ratio (HR)|0.37|||||TWO_SIDED|95.0|0.12|1.15|||Regression, Cox|adjusted for age and centre||Day 14||1.15|0.12|
73892800|NCT05367492|147318517|SUPERIORITY|||||||0.02||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus Wald test of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups.||||||0.02
73798750|NCT04331808|147145350|SUPERIORITY||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.32|1.47|||Regression, Cox|adjusted for age and centre||Day 28||1.47|0.32|
73798751|NCT04331808|147145350|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.3|1.49|||Regression, Cox|adjusted for age and centre||Day 90||1.49|0.30|
73798752|NCT04331808|147145351|SUPERIORITY||Median posterior OR|0.6|||||TWO_SIDED|95.0|0.27|1.28|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 4||1.28|0.27|
73798753|NCT04331808|147145351|SUPERIORITY||Median posterior OR|0.86|||||TWO_SIDED|95.0|0.43|1.71|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre||Day 7|% Confidence Interval is % Credible Interval here|1.71|0.43|
73798754|NCT04331808|147145351|SUPERIORITY||Median posterior OR|0.76|||||TWO_SIDED|95.0|0.4|1.42|||Proportionnal odds model|Bayesian analysis. Adjusted for age and sex|% Confidence Interval is % Credible Interval here|Day 14||1.42|0.40|
73798755|NCT04331808|147145351|SUPERIORITY||Median posterior OR|0.85|||||TWO_SIDED|95.0|0.39|1.82|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre||Day 4|% Confidence Interval is % Credible Interval here|1.82|0.39|
73892801|NCT05367492|147318518|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.16
73798756|NCT04331808|147145351|SUPERIORITY||Median posterior OR|0.69|||||TWO_SIDED|95.0|0.32|1.47|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 7||1.47|0.32|
73798757|NCT04331808|147145351|SUPERIORITY||Median posterior OR|0.68|||||TWO_SIDED|95.0|0.32|1.43|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 14||1.43|0.32|
73798758|NCT04331808|147145352|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-6.9|1.7||adjusted on age and centre||||||1.7|-6.9|
73798759|NCT04331808|147145353|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.98|2.01|||Fine-Gray model|adjusted for age and centre||Day 28||2.01|0.98|
73798760|NCT04331808|147145353|SUPERIORITY||Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.82|2.52|||Fine-Gray model|||Day 28||2.52|0.82|
73798761|NCT04331808|147145353|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.8|2.03|||Fine-Gray model|adjusted on age and centre||Day 90||2.03|0.80|
73798762|NCT04331808|147145354|SUPERIORITY||Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|1.02|2.27|||Fine-Gray model|adjusted on age and centre||Day 28||2.27|1.02|
73798763|NCT04331808|147145354|SUPERIORITY||Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.8|2.63|||Fine-Gray model|adjusted for age and centre||Day 28||2.63|0.80|
73798764|NCT04331808|147145354|SUPERIORITY||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.84|2.17|||Fine-Gray model|adjusted for age and centre||Day 90||2.17|0.84|
73798765|NCT04331808|147145355|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.73|1.81|||Fine-Gray model|adjusted on age and centre||Day 28||1.81|0.73|
73798766|NCT04331808|147145355|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.73|2.24|||Fine-Gray model|adjusted on age and centre||Day 90||2.24|0.73|
73798767|NCT01184079|147145359|NON_INFERIORITY_OR_EQUIVALENCE|"Sample size: (1 + 1/u)(Zα + Zβ)2 σ2 /\[log (RGMT) -δ0\] u= ratio of the size of the Standard schedule to Alternate schedule groups (u =1, for equal size groups); one-sided alpha (0.025)/4 for multiplicity of serotypes. Average log-transformed and geometric mean titers (GMTs) with a two-sided 95% confidence interval of the ratio of the GMTs were used.~Non-inferiority is determined if upper bound GMT ratio of standard group to alternate group \< 1.5."|largest upper bound GMT ratio|0.82|||||||||||||Non-inferiority is determined if upper bound GMT ratio of standard 6 month group to alternate 12 month group \< 1.5.|The primary endpoint would demonstrate noninferiority if the upper bound of the 95% two-sided confidence interval (CI) of the ratio of GMT for Standard schedule group divided by that of Alternate schedule group is \<1.5.||||
73798768|NCT01184079|147145361|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Chi-squared|||null hypothsesis: no difference in proportion of side effects reported between groups||||0.26
73798769|NCT00681031|147145365|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptability was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) on the Geometric Mean Fold Rise (CMFR) from pre-vaccination to 4 weeks postvaccination is \>1.4.|GMFR|3.1|||||TWO_SIDED|95.0|2.6|3.8|||||GMFR = GMT postdose divided by GMT predose|||3.8|2.6|
73798770|NCT04927845|147145379|SUPERIORITY||between-group effect size Cohen's d|0.24||||0.008|TWO_SIDED|95.0|0.06|0.41|||linear mixed effects, groupXtime term|||||0.41|0.06|.008
73798771|NCT04927845|147145379|SUPERIORITY||Slope|1.75||||0.03|TWO_SIDED||||||linear mixed effects, groupXtime term|||Per Protocol Analyses of Intervention Effects: comparing the waitlist condition versus only intervention group participants who were program initiators||||.03
73798772|NCT04927845|147145379|SUPERIORITY|||||||0.009|||||||linear mixed effects, groupXtime term|||Per Protocol Analyses of Intervention Effects: concurrent service use was added as a covariate to models.||||.009
73798773|NCT04927845|147145380|SUPERIORITY||between-group effect size Cohen's d|0.11||||0.21|TWO_SIDED||||||linear mixed effects, groupXtime term|||||||.21
73798774|NCT04927845|147145381|SUPERIORITY||between-group effect size Cohen's d|0.19||||0.046|TWO_SIDED|95.0|0.02|0.36|||linear mixed effects, groupXtime term|||||0.36|0.02|.046
73798775|NCT02603146|147145383|OTHER||Cumulative Probability|0.336|||||TWO_SIDED|95.0|0.213|0.459|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 36 for HCQ.|||0.459|0.213|
73798776|NCT02603146|147145383|OTHER||Cumulative Probability|0.394|||||TWO_SIDED|95.0|0.268|0.519|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 36 for Placebo.|||0.519|0.268|
73798777|NCT02603146|147145383|SUPERIORITY|"The analysis is based on the KM estimated risk of CL- RA at 36 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of CL-RA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.058||||0.522|TWO_SIDED|95.0|-0.336|0.22||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.220|-0.336|0.522
73892802|NCT05367492|147318518|SUPERIORITY|||||||0.083|||||||Fisher Exact|||||||0.083
73798778|NCT02603146|147145384|OTHER||Cumulative Probability|0.165|||||TWO_SIDED|95.0|0.076|0.225|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 12 for HCQ.|||0.225|0.076|
73798779|NCT02603146|147145384|OTHER||Cumulative Probability|0.194|||||TWO_SIDED|95.0|0.099|0.289|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 12 for Placebo.|||0.289|0.099|
73798780|NCT02603146|147145384|SUPERIORITY|"The analysis is based on the KM estimated risk of CL- RA at 12 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of CL-RA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.029||||0.668|TWO_SIDED|95.0|-0.188|0.131||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.131|-0.188|0.668
73798781|NCT02603146|147145385|OTHER||Cumulative Probability|0.18|||||TWO_SIDED|95.0|0.088|0.273|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 12 for HCQ.|||0.273|0.088|
73798782|NCT02603146|147145385|OTHER||Cumulative Probability|0.194|||||TWO_SIDED|95.0|0.099|0.289|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 12 for Placebo.|||0.289|0.099|
73798783|NCT02603146|147145385|SUPERIORITY|"The analysis is based on the KM estimated risk of IA at 12 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of IA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.014||||0.84|TWO_SIDED|95.0|-0.177|0.15||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.150|-0.177|0.840
73798784|NCT02603146|147145386|SUPERIORITY|||||||0.652|||||||Log Rank|||||||0.652
73798785|NCT02603146|147145387|OTHER||Cumulative Probability|0.356|||||TWO_SIDED|95.0|0.23|0.482|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 36 for HCQ.|||0.482|0.230|
73798786|NCT02603146|147145387|OTHER||Cumulative Probability|0.425|||||TWO_SIDED|95.0|0.298|0.551|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 36 for Placebo.|||0.551|0.298|
73798787|NCT02603146|147145387|SUPERIORITY|"The analysis is based on the KM estimated risk of IA at 36 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of IA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.069||||0.452|TWO_SIDED|95.0|-0.363|0.226||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.226|-0.363|0.452
73798788|NCT02603146|147145388|SUPERIORITY|||||||0.928||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.928
73892803|NCT03085797|147318531|SUPERIORITY||Difference in Medians|-0.73|||<|0.001|TWO_SIDED|95.0|-1.11|-0.34||p-Value was based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment,region,Baseline score,Baseline eosinophilcount(BEC). Par. with nasal surgery prior to Wk52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal|||-0.34|-1.11|<0.001
73892804|NCT03085797|147318532|SUPERIORITY||Difference in Medians|-3.14|||<|0.001|TWO_SIDED|95.0|-4.09|-2.18||p-Value was based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-2.18|-4.09|<0.001
73798789|NCT02603146|147145388|SUPERIORITY|||||||0.076||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.076
73798790|NCT02603146|147145389|SUPERIORITY|||||||0.781||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.781
73798791|NCT02603146|147145389|SUPERIORITY|||||||0.457||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.457
73798792|NCT02603146|147145390|SUPERIORITY|||||||0.576||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.576
73798793|NCT02603146|147145390|SUPERIORITY|||||||0.323||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.323
73798794|NCT02603146|147145391|SUPERIORITY|||||||0.865||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.865
73798795|NCT02603146|147145391|SUPERIORITY|||||||0.179||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.179
73798796|NCT02603146|147145392|SUPERIORITY|||||||0.634||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.634
73798797|NCT02603146|147145392|SUPERIORITY|||||||0.574||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.574
73798798|NCT02603146|147145393|SUPERIORITY|||||||0.724||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.724
73798799|NCT02603146|147145393|SUPERIORITY|||||||0.149||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.149
73798800|NCT02603146|147145397|SUPERIORITY|||||||0.809|||||||Fisher Exact|||||||0.809
73798801|NCT04467840|147145409|SUPERIORITY||Risk Difference (RD)|3.86||||0.391|TWO_SIDED|95.0|-4.93|12.65||The threshold for statistical significance was p = 0.05|Cochran-Mantel-Haenszel||Opaganib - Placebo|||12.65|-4.93|0.391
73798802|NCT04467840|147145410|SUPERIORITY||Risk Difference (RD)|3.91||||0.38|TWO_SIDED|95.0|-4.78|12.6||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Cochran-Mantel-Haenszel|||||12.60|-4.78|0.380
73798803|NCT04467840|147145411|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.231|TWO_SIDED|95.0|0.91|1.45||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.45|0.91|0.231
73798804|NCT04467840|147145412|SUPERIORITY||Hazard Ratio, log|1.08||||0.472|TWO_SIDED|95.0|0.87|1.33||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.33|0.87|0.472
73798805|NCT04467840|147145413|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.521|TWO_SIDED|95.0|0.846|1.378||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.378|0.846|0.521
73798806|NCT04467840|147145414|SUPERIORITY||Risk Difference (RD)|-1.51||||0.701|TWO_SIDED|95.0|-9.19|6.18||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Cochran-Mantel-Haenszel|||||6.18|-9.19|0.701
73798807|NCT04467840|147145415|SUPERIORITY|The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Hazard Ratio (HR)|1.34||||0.043|TWO_SIDED|95.0|0.99|1.82|||Log Rank|||||1.82|0.99|0.043
73798808|NCT04467840|147145416|SUPERIORITY|The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Risk Difference (RD)|8.3||||0.118|TWO_SIDED|95.0|-2.05|18.65|||Cochran-Mantel-Haenszel|||||18.65|-2.05|0.118
73798809|NCT04467840|147145420|SUPERIORITY||Risk Difference (RD)|12.28||||0.033|TWO_SIDED|95.0|1.06|23.5||unadjusted p-value|Cochran-Mantel-Haenszel|||||23.50|1.06|0.033
73798810|NCT04467840|147145421|SUPERIORITY||Risk Difference (RD)|-4.75||||0.5|TWO_SIDED|95.0|-18.67|9.17|||Cochran-Mantel-Haenszel|||||9.17|-18.67|0.500
73798811|NCT04467840|147145422|SUPERIORITY||Risk Difference (RD)|12.75||||0.023|TWO_SIDED|95.0|1.9|23.6|||Cochran-Mantel-Haenszel|||||23.60|1.90|0.023
73798812|NCT04467840|147145423|SUPERIORITY||Risk Difference (RD)|-4.12||||0.561|TWO_SIDED|95.0|-18.07|9.82|||Cochran-Mantel-Haenszel|||||9.82|-18.07|0.561
73798813|NCT04467840|147145424|SUPERIORITY||Hazard Ratio (HR)|1.44||||0.01|TWO_SIDED|95.0|1.07|1.93|||Log Rank|||||1.93|1.07|0.01
73798814|NCT04467840|147145425|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.545|TWO_SIDED|95.0|0.58|1.34|||Log Rank|||||1.34|0.58|0.545
73798815|NCT04467840|147145426|SUPERIORITY||Hazard Ratio (HR)|1.276||||0.1|TWO_SIDED|95.0|0.94|1.732|||Log Rank|||||1.732|0.940|0.100
73798816|NCT04467840|147145428|SUPERIORITY||Risk Difference (RD)|-10.5||||0.012|TWO_SIDED|95.0|-18.44|-2.57|||Cochran-Mantel-Haenszel|||||-2.57|-18.44|0.012
73798817|NCT04467840|147145429|SUPERIORITY||Risk Difference (RD)|7.2||||0.304|TWO_SIDED|95.0|-6.46|20.86|||Cochran-Mantel-Haenszel|||||20.86|-6.46|0.304
73798818|NCT04467840|147145430|SUPERIORITY||Risk Difference (RD)|-9.22||||0.019|TWO_SIDED|95.0|-16.63|-1.8|||Cochran-Mantel-Haenszel|||||-1.80|-16.63|0.019
73798819|NCT04467840|147145431|SUPERIORITY||Risk Difference (RD)|7.37||||0.273|TWO_SIDED|95.0|-5.66|20.39|||Cochran-Mantel-Haenszel|||||20.39|-5.66|0.273
73798820|NCT05201794|147145434|SUPERIORITY||Odds Ratio (OR)|67.3|||=|0.1409|ONE_SIDED|80.0|15.2|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for proof-of-concept (PoC) when the planned interim analysis would have been performed.|||15.2|=0.1409
73798821|NCT05201794|147145434|SUPERIORITY||Odds Ratio (OR)|67.2|||=|0.1418|ONE_SIDED|80.0|14.9|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||14.9|=0.1418
73798822|NCT05201794|147145435|SUPERIORITY||Odds Ratio (OR)|87.8|||=|0.0192|ONE_SIDED|80.0|58.1|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||58.1|=0.0192
73798823|NCT05201794|147145435|SUPERIORITY||Odds Ratio (OR)|62.9|||=|0.1131|ONE_SIDED|80.0|20.0|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||20|=0.1131
73798824|NCT05201794|147145436|SUPERIORITY||Odds Ratio (OR)|85.4|||=|0.0302|ONE_SIDED|80.0|62.6|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||62.6|=0.0302
73892805|NCT03085797|147318533|SUPERIORITY||Hazard Ratio (Mepolizumab/Placebo)|0.43||||0.003|TWO_SIDED|95.0|0.25|0.76||p-Value was based on Cox Proportional Hazards Model.|Cox Proportional Hazards Model||Analysis using a Cox Proportional Hazards Model with covariates of treatment, geographic region, Baseline total endoscopic score (centrally read), Baseline nasal obstruction VAS, Baseline BEC, number of previous surgeries (1, 2, \>2 as ordinal).|||0.76|0.25|0.003
73798825|NCT05201794|147145436|SUPERIORITY||Odds Ratio (OR)|60.5|||=|0.2239|ONE_SIDED|80.0|-6.3|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||-6.3|=0.2239
73798826|NCT06418529|147145443|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.85|1.05||||||||1.05|0.85|
73798827|NCT06418529|147145444|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.83|1.07||||||||1.07|0.83|
73798828|NCT06418529|147145445|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.79|0.99||||||||0.99|0.79|
73798829|NCT06418529|147145446|OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.79|1.04||||||||1.04|0.79|
73798830|NCT06418529|147145447|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.81|1.05||||||||1.05|0.81|
73798831|NCT06418529|147145448|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.09||||||||1.09|0.79|
73798832|NCT04848480|147145474|NON_INFERIORITY|Non-inferiority was considered confirmed if the estimated treatment difference was below 0.3%.|Treatment difference|0.05||||0.0065|TWO_SIDED|95.0|-0.13|0.23|||ANCOVA|||Change from baseline in HbA1c after 26 weeks was analysed using ANCOVA model with treatment, region, HbA1c group at screening and pre-trial basal insulin treatment as fixed factors, and baseline response as covariate.||0.23|-0.13|0.0065
73798833|NCT03176134|147145495|OTHER||Estimated Difference|6.5|||||TWO_SIDED|95.0|-12.2|25.3|||||The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.|||25.3|-12.2|
73798834|NCT03176134|147145495|OTHER||Estimated Difference|-12.5|||||TWO_SIDED|95.0|-28.7|3.7|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||3.7|-28.7|
73798835|NCT03176134|147145495|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
73798836|NCT03176134|147145495|OTHER||Estimated Difference|1.3|||||TWO_SIDED|95.0|-10.7|13.4|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||13.4|-10.7|
73798837|NCT03176134|147145496|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
73892806|NCT03085797|147318534|OTHER||Difference in Medians|-3.18||||0.003|TWO_SIDED|95.0|-4.1|-2.26||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-2.26|-4.10|0.003
73798838|NCT03176134|147145496|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
73798839|NCT03176134|147145496|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
73798840|NCT03176134|147145496|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
73798841|NCT03718832|147145592|SUPERIORITY||Mean Difference (Net)|-0.0333487|STANDARD_ERROR_OF_MEAN|0.1943638||0.8638688|TWO_SIDED|95.0|-0.415628|0.3489306||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.3489306|-0.415628|0.8638688
73798842|NCT03718832|147145592|SUPERIORITY||Mean Difference (Net)|-0.0066385|STANDARD_ERROR_OF_MEAN|0.1853917||0.9714571|TWO_SIDED|95.0|-0.371329|0.358052||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.358052|-0.371329|0.9714571
73798843|NCT03718832|147145593|SUPERIORITY||Mean Difference (Net)|0.1409446|STANDARD_ERROR_OF_MEAN|0.2106711||0.5039565|TWO_SIDED|95.0|-0.2735162|0.5554053||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.5554053|-0.2735162|0.5039565
73798844|NCT03718832|147145593|SUPERIORITY||Mean Difference (Net)|0.1213915|STANDARD_ERROR_OF_MEAN|0.2126328||0.5684854|TWO_SIDED|95.0|-0.2970052|0.5397882||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.5397882|-0.2970052|0.5684854
73798845|NCT03718832|147145594|SUPERIORITY||Mean Difference (Net)|-13.26835|STANDARD_ERROR_OF_MEAN|10.90353||0.2247426|TWO_SIDED|95.0|-34.73804|8.201347||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||8.201347|-34.73804|0.2247426
73798846|NCT03718832|147145594|SUPERIORITY||Mean Difference (Net)|-12.20164|STANDARD_ERROR_OF_MEAN|11.25555||0.2794015|TWO_SIDED|95.0|-34.37119|9.9679||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||9.9679|-34.37119|0.2794015
73798847|NCT03718832|147145594|SUPERIORITY||Mean Difference (Net)|13.12548|STANDARD_ERROR_OF_MEAN|9.550462||0.1708328|TWO_SIDED|95.0|-5.703702|31.95466||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||31.95466|-5.703702|0.1708328
73798848|NCT03718832|147145594|SUPERIORITY||Mean Difference (Net)|11.47577|STANDARD_ERROR_OF_MEAN|10.59479||0.2801138|TWO_SIDED|95.0|-9.422762|32.3743||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||32.3743|-9.422762|0.2801138
73892807|NCT03085797|147318535|OTHER||Difference in Medians|-16.49||||0.003|TWO_SIDED|95.0|-23.57|-9.42||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wk 52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal.|||-9.42|-23.57|0.003
73892808|NCT03085797|147318536|OTHER||Odds Ratio (OR)|0.58||||0.02|TWO_SIDED|95.0|0.36|0.92||p-Value was based on logistic regression model and is adjusted for multiplicity.|Regression, Logistic||Covariates: treatment group, geographic region, number of oral corticosteroids courses for NP in last 12 months(0,1,\>1 as ordinal), Baseline total endoscopic score(centrally read),Baseline nasal obstruction VAS score,log(e) Baseline eosinophil count.|||0.92|0.36|0.020
73892809|NCT03085797|147318537|OTHER||Difference in Medians|-2.68||||0.02|TWO_SIDED|95.0|-3.44|-1.91||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-1.91|-3.44|0.020
73892810|NCT03085797|147318538|OTHER||Difference in Medians|-0.37||||0.02|TWO_SIDED|95.0|-0.65|-0.08||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-0.08|-0.65|0.020
73892811|NCT01837823|147318542|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.231||||0.054|TWO_SIDED||||||Regression, Linear|||||||0.054
73892812|NCT01837823|147318543|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.074||||0.5|TWO_SIDED||||||Pearson correlation coefficient|||for minimum lumen area site||||0.50
73892813|NCT02914301|147318565|OTHER|We compared outcomes between study arms using t-tests for continuous outcomes.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73892814|NCT01305577|147318726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.73|||<|0.001|TWO_SIDED|95.0|2.7|8.28|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||8.28|2.70|<0.001
73892815|NCT01305577|147318726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.21|||<|0.001|TWO_SIDED|95.0|3.52|10.94|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo. An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme.||10.94|3.52|<0.001
73892816|NCT01305577|147318727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58||||0.028|TWO_SIDED|95.0|1.2|25.87|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||25.87|1.20|0.028
73892817|NCT01305577|147318727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.05|||<|0.001|TWO_SIDED|95.0|2.75|52.9|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||52.90|2.75|<0.001
73892818|NCT01305577|147318728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99|||<|0.001|TWO_SIDED|95.0|1.74|5.14|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||5.14|1.74|<0.001
73892819|NCT01305577|147318728|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.22|||<|0.001|TWO_SIDED|95.0|2.99|9.11|||Regression, Logistic|Logistic regression analysis with treatment and baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||9.11|2.99|<0.001
73798849|NCT03718832|147145595|SUPERIORITY||Mean Difference (Net)|-8.135585|STANDARD_ERROR_OF_MEAN|6.325031||0.1991028|TWO_SIDED|95.0|-20.57023|4.299061||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||4.299061|-20.57023|0.1991028
73798850|NCT03718832|147145595|SUPERIORITY||Mean Difference (Net)|3.493798|STANDARD_ERROR_OF_MEAN|1.761916||0.0480884|TWO_SIDED|95.0|0.0295297|6.958066||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||6.958066|0.0295297|0.0480884
73798851|NCT03718832|147145595|SUPERIORITY||Mean Difference (Net)|-9.681804|STANDARD_ERROR_OF_MEAN|6.34136||0.1276817|TWO_SIDED|95.0|-22.15188|2.788269||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.788269|-22.15188|0.1276817
73798852|NCT03718832|147145595|SUPERIORITY||Mean Difference (Net)|1.658257|STANDARD_ERROR_OF_MEAN|1.706497||0.3318554|TWO_SIDED|95.0|-1.698022|5.014535||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||5.014535|-1.698022|0.3318554
73798853|NCT03718832|147145596|SUPERIORITY||Mean Difference (Net)|-0.8749266|STANDARD_ERROR_OF_MEAN|0.9355095||0.3502313|TWO_SIDED|95.0|-2.714084|0.9642311||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.9642311|-2.714084|0.3502313
73798854|NCT03718832|147145596|SUPERIORITY||Mean Difference (Net)|0.5608222|STANDARD_ERROR_OF_MEAN|0.2708671||0.0390797|TWO_SIDED|95.0|0.0282451|1.093399||Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.093399|0.0282451|0.0390797
73798855|NCT03718832|147145596|SUPERIORITY||Mean Difference (Net)|-1.450197|STANDARD_ERROR_OF_MEAN|0.9508997||0.1281032|TWO_SIDED|95.0|-3.320109|0.419716||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.419716|-3.320109|0.1281032
73798856|NCT03718832|147145596|SUPERIORITY||Mean Difference (Net)|0.2794625|STANDARD_ERROR_OF_MEAN|0.2717457||0.3044732|TWO_SIDED|95.0|-0.2549974|0.8139224||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.8139224|-0.2549974|0.3044732
73798857|NCT03718832|147145597|SUPERIORITY||Mean Difference (Net)|9.768353|STANDARD_ERROR_OF_MEAN|5.933945||0.1007463|TWO_SIDED|95.0|-1.907847|21.44455||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||21.44455|-1.907847|0.1007463
73798858|NCT03718832|147145597|SUPERIORITY||Mean Difference (Net)|4.472004|STANDARD_ERROR_OF_MEAN|5.150772||0.3859868|TWO_SIDED|95.0|-5.66534|14.60935||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||14.60935|-5.66534|0.3859868
73798859|NCT03718832|147145597|SUPERIORITY||Mean Difference (Net)|-0.5461143|STANDARD_ERROR_OF_MEAN|6.440905||0.9324908|TWO_SIDED|95.0|-13.22545|12.13323||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Unadjusted mean difference, 12 months after trial enrollment||12.13323|-13.22545|0.9324908
73798860|NCT03718832|147145597|SUPERIORITY||Mean Difference (Net)|-2.752831|STANDARD_ERROR_OF_MEAN|5.754947||0.6328075|TWO_SIDED|95.0|-14.08487|8.579205||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||8.579205|-14.08487|0.6328075
73798861|NCT03718832|147145598|SUPERIORITY||Mean Difference (Net)|8.352141|STANDARD_ERROR_OF_MEAN|4.663846||0.0743062|TWO_SIDED|95.0|-0.8250086|17.52929||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||17.52929|-0.8250086|0.0743062
73798862|NCT03718832|147145598|SUPERIORITY||Mean Difference (Net)|5.971188|STANDARD_ERROR_OF_MEAN|3.902349||0.1270654|TWO_SIDED|95.0|-1.709219|13.65159||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||13.65159|-1.709219|0.1270654
73798863|NCT03718832|147145598|SUPERIORITY||Mean Difference (Net)|2.637485|STANDARD_ERROR_OF_MEAN|4.443227||0.553277|TWO_SIDED|95.0|-6.110146|11.38512||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||11.38512|-6.110146|0.553277
73798864|NCT03718832|147145598|SUPERIORITY||Mean Difference (Net)|2.53149|STANDARD_ERROR_OF_MEAN|3.925307||0.519562|TWO_SIDED|95.0|-5.198658|10.26164||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||10.26164|-5.198658|0.519562
73798865|NCT03718832|147145599|SUPERIORITY||Mean Difference (Net)|-0.555117|STANDARD_ERROR_OF_MEAN|1.427417||0.6976216|TWO_SIDED|95.0|-3.363839|2.253605||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.253605|-3.363839|0.6976216
73798866|NCT03718832|147145599|SUPERIORITY||Mean Difference (Net)|-0.4977997|STANDARD_ERROR_OF_MEAN|1.041102||0.6329035|TWO_SIDED|95.0|-2.546815|1.551216||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.551216|-2.546815|0.6329035
73798867|NCT03718832|147145599|SUPERIORITY||Mean Difference (Net)|-1.386111|STANDARD_ERROR_OF_MEAN|1.812939||0.445181|TWO_SIDED|95.0|-4.954999|2.182777||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.182777|-4.954999|0.445181
73798868|NCT03718832|147145599|SUPERIORITY||Mean Difference (Net)|-1.101914|STANDARD_ERROR_OF_MEAN|1.860687||0.5542241|TWO_SIDED|95.0|-4.765783|2.561956||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||2.561956|-4.765783|0.5542241
73798869|NCT03718832|147145600|SUPERIORITY||Mean Difference (Net)|22.55812|STANDARD_ERROR_OF_MEAN|17.74244||0.2045348|TWO_SIDED|95.0|-12.35316|57.4694||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||57.4694|-12.35316|0.2045348
73798870|NCT03718832|147145600|SUPERIORITY||Mean Difference (Net)|13.49781|STANDARD_ERROR_OF_MEAN|14.95579||0.3675252|TWO_SIDED|95.0|-15.93658|42.9322||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||42.9322|-15.93658|0.3675252
73798871|NCT03718832|147145600|SUPERIORITY||Mean Difference (Net)|-11.35256|STANDARD_ERROR_OF_MEAN|26.69115||0.6709307|TWO_SIDED|95.0|-63.8992|41.19407||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||41.19407|-63.8992|0.6709307
73798872|NCT03718832|147145600|SUPERIORITY||Mean Difference (Net)|-8.912496|STANDARD_ERROR_OF_MEAN|21.34891||0.6766844|TWO_SIDED|95.0|-50.95358|33.12859||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||33.12859|-50.95358|0.6766844
73798873|NCT03718832|147145601|SUPERIORITY||Mean Difference (Net)|-1.870464|STANDARD_ERROR_OF_MEAN|2.024497||0.356123|TWO_SIDED|95.0|-5.851219|2.110291||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.110291|-5.851219|0.356123
73798874|NCT03718832|147145601|SUPERIORITY||Mean Difference (Net)|-0.8636408|STANDARD_ERROR_OF_MEAN|1.941141||0.6566494|TWO_SIDED|95.0|-4.681041|2.95376||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2.95376|-4.681041|0.6566494
73798875|NCT03718832|147145601|SUPERIORITY||Mean Difference (Net)|-3.772051|STANDARD_ERROR_OF_MEAN|1.905125||0.0484944|TWO_SIDED|95.0|-7.519021|-0.0250809||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||-0.0250809|-7.519021|0.0484944
73798876|NCT03718832|147145601|SUPERIORITY||Mean Difference (Net)|-2.167034|STANDARD_ERROR_OF_MEAN|1.821244||0.234947|TWO_SIDED|95.0|-5.749627|1.415558||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1.415558|-5.749627|0.234947
73798877|NCT03718832|147145602|SUPERIORITY||Mean Difference (Net)|-0.5561156|STANDARD_ERROR_OF_MEAN|1.086759||0.6091477|TWO_SIDED|95.0|-2.693002|1.58077||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.58077|-2.693002|0.6091477
73798878|NCT03718832|147145602|SUPERIORITY||Mean Difference (Net)|-0.3787962|STANDARD_ERROR_OF_MEAN|1.032547||0.713942|TWO_SIDED|95.0|-2.409379|1.651786||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.651786|-2.409379|0.713942
73798879|NCT03718832|147145602|SUPERIORITY||Mean Difference (Net)|0.4989275|STANDARD_ERROR_OF_MEAN|1.053869||0.6362064|TWO_SIDED|95.0|-1.573807|2.571662||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.571662|-1.573807|0.6362064
73798880|NCT03718832|147145602|SUPERIORITY||Mean Difference (Net)|1.146286|STANDARD_ERROR_OF_MEAN|1.048105||0.2748884|TWO_SIDED|95.0|-0.9154561|3.208027||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||3.208027|-0.9154561|0.2748884
73798881|NCT03718832|147145603|SUPERIORITY||Mean Difference (Net)|0.3232407|STANDARD_ERROR_OF_MEAN|0.3695066||0.3823224|TWO_SIDED|95.0|-0.4036366|1.050118||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.050118|-0.4036366|0.3823224
73798882|NCT03718832|147145603|SUPERIORITY||Mean Difference (Net)|0.2619965|STANDARD_ERROR_OF_MEAN|0.3729922||0.4829339|TWO_SIDED|95.0|-0.4718566|0.9958495||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.9958495|-0.4718566|0.4829339
73798883|NCT03718832|147145603|SUPERIORITY||Mean Difference (Net)|-0.6983982|STANDARD_ERROR_OF_MEAN|0.3476441||0.045506|TWO_SIDED|95.0|-1.382737|-0.0140597||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||-0.0140597|-1.382737|0.045506
73798884|NCT03718832|147145603|SUPERIORITY||Mean Difference (Net)|-0.6239824|STANDARD_ERROR_OF_MEAN|0.3336405||0.0625551|TWO_SIDED|95.0|-1.280906|0.0329412||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0329412|-1.280906|0.0625551
73798885|NCT03718832|147145604|SUPERIORITY||Mean Difference (Net)|2.276579|STANDARD_ERROR_OF_MEAN|1.636162||0.1650343|TWO_SIDED|95.0|-0.9420086|5.495166||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||5.495166|-0.9420086|0.1650343
73798886|NCT03718832|147145604|SUPERIORITY||Mean Difference (Net)|1.989458|STANDARD_ERROR_OF_MEAN|1.359013||0.1442126|TWO_SIDED|95.0|-0.6843682|4.663284||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||4.663284|-0.6843682|0.1442126
73798887|NCT03718832|147145604|SUPERIORITY||Mean Difference (Net)|-1.579811|STANDARD_ERROR_OF_MEAN|0.739612||0.0335498|TWO_SIDED|95.0|-3.03574|-0.1238828||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||-0.1238828|-3.03574|0.0335498
73798888|NCT03718832|147145604|SUPERIORITY||Mean Difference (Net)|-1.764632|STANDARD_ERROR_OF_MEAN|0.8545352||0.0398937|TWO_SIDED|95.0|-3.447175|-0.0820899||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||-0.0820899|-3.447175|0.0398937
73798889|NCT03718832|147145605|SUPERIORITY||Mean Difference (Net)|-0.6294078|STANDARD_ERROR_OF_MEAN|0.4409795||0.1544491|TWO_SIDED|95.0|-1.496923|0.238107||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.238107|-1.496923|0.1544491
73798890|NCT03718832|147145605|SUPERIORITY||Mean Difference (Net)|-0.6081765|STANDARD_ERROR_OF_MEAN|0.451915||0.1793486|TWO_SIDED|95.0|-1.497352|0.2809987||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.2809987|-1.497352|0.1793486
73798891|NCT03718832|147145605|SUPERIORITY||Mean Difference (Net)|-0.1731023|STANDARD_ERROR_OF_MEAN|0.4024787||0.6674618|TWO_SIDED|95.0|-0.9653829|0.6191784||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.6191784|-0.9653829|0.6674618
73798892|NCT03718832|147145605|SUPERIORITY||Mean Difference (Net)|-0.2208031|STANDARD_ERROR_OF_MEAN|0.4196435||0.5992113|TWO_SIDED|95.0|-1.047063|0.6054567||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.6054567|-1.047063|0.5992113
73892820|NCT01305577|147318729|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.35|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.35|-0.68|<0.001
73798893|NCT03718832|147145606|SUPERIORITY||Mean Difference (Net)|0.4824561|STANDARD_ERROR_OF_MEAN|0.423027||0.2549037|TWO_SIDED|95.0|-0.349686|1.314598||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.314598|-0.349686|0.2549037
73798894|NCT03718832|147145606|SUPERIORITY||Mean Difference (Net)|0.3545817|STANDARD_ERROR_OF_MEAN|0.4230741||0.4025977|TWO_SIDED|95.0|-0.4777863|1.186949||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.186949|-0.4777863|0.4025977
73798895|NCT03718832|147145606|SUPERIORITY||Mean Difference (Net)|-0.0102657|STANDARD_ERROR_OF_MEAN|0.4695747||0.9825739|TWO_SIDED|95.0|-0.9346107|0.9140792||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.9140792|-0.9346107|0.9825739
73798896|NCT03718832|147145606|SUPERIORITY||Mean Difference (Net)|-0.0340184|STANDARD_ERROR_OF_MEAN|0.4869778||0.9443607|TWO_SIDED|95.0|-0.9928399|0.9248032||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.9248032|-0.9928399|0.9443607
73798897|NCT03718832|147145607|SUPERIORITY||Mean Difference (Net)|0.160997|STANDARD_ERROR_OF_MEAN|0.0376773||2.52e-05|TWO_SIDED|95.0|0.0868814|0.2351126||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.2351126|0.0868814|0.0000252
73798898|NCT03718832|147145607|SUPERIORITY||Mean Difference (Net)|0.1691707|STANDARD_ERROR_OF_MEAN|0.0391132||2.04e-05|TWO_SIDED|95.0|0.0922183|0.2461232||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.2461232|0.0922183|0.0000204
73798899|NCT03718832|147145607|SUPERIORITY||Mean Difference (Net)|0.0028595|STANDARD_ERROR_OF_MEAN|0.0261733||0.9130816|TWO_SIDED|95.0|-0.0486635|0.0543825||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0543825|-0.0486635|0.9130816
73798900|NCT03718832|147145607|SUPERIORITY||Mean Difference (Net)|0.0166325|STANDARD_ERROR_OF_MEAN|0.0271062||0.5400053|TWO_SIDED|95.0|-0.0367394|0.0700045||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0700045|-0.0367394|0.5400053
73798901|NCT03718832|147145608|SUPERIORITY||Mean Difference (Net)|0.0511555|STANDARD_ERROR_OF_MEAN|0.016316||0.0018721|TWO_SIDED|95.0|0.0190582|0.0832528||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0832528|0.0190582|0.0018721
73798902|NCT03718832|147145608|SUPERIORITY||Mean Difference (Net)|0.0433081|STANDARD_ERROR_OF_MEAN|0.0168497||0.0106231|TWO_SIDED|95.0|0.0101555|0.0764607||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.0764607|0.0101555|0.0106231
73798903|NCT03718832|147145608|SUPERIORITY||Mean Difference (Net)|0.0138256|STANDARD_ERROR_OF_MEAN|0.0171112||0.4197898|TWO_SIDED|95.0|-0.0198584|0.0475096||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0475096|-0.0198584|0.4197898
73892821|NCT01305577|147318729|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.50|-0.84|<0.001
73798904|NCT03718832|147145608|SUPERIORITY||Mean Difference (Net)|0.0179852|STANDARD_ERROR_OF_MEAN|0.0171811||0.2961479|TWO_SIDED|95.0|-0.0158442|0.0518147||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0518147|-0.0158442|0.2961479
73892822|NCT01305577|147318730|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04|||<|0.001|TWO_SIDED|95.0|0.61|1.47|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.47|0.61|<0.001
73892823|NCT01305577|147318730|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41|||<|0.001|TWO_SIDED|95.0|0.99|1.84|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.84|0.99|<0.001
73892824|NCT01305577|147318731|SUPERIORITY_OR_OTHER||LS mean Difference|-1.68|||<|0.001|TWO_SIDED|95.0|-2.5|-0.87|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||-0.87|-2.50|<0.001
73798905|NCT03718832|147145609|SUPERIORITY||Mean Difference (Net)|0.4018522|STANDARD_ERROR_OF_MEAN|0.1001575||7.43e-05|TWO_SIDED|95.0|0.2048311|0.5988733||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.5988733|0.2048311|0.0000743
73798906|NCT03718832|147145609|SUPERIORITY||Mean Difference (Net)|0.3643095|STANDARD_ERROR_OF_MEAN|0.1026922||0.0004471|TWO_SIDED|95.0|0.16227|0.566349||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.566349|0.16227|0.0004471
73798907|NCT03718832|147145609|SUPERIORITY||Mean Difference (Net)|0.0006229|STANDARD_ERROR_OF_MEAN|0.1095781||0.9954683|TWO_SIDED|95.0|-0.2150785|0.2163243||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.2163243|-0.2150785|0.9954683
73798908|NCT03718832|147145609|SUPERIORITY||Mean Difference (Net)|-0.0161147|STANDARD_ERROR_OF_MEAN|0.1115322||0.8852268|TWO_SIDED|95.0|-0.2357129|0.2034834||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.2034834|-0.2357129|0.8852268
73892825|NCT01305577|147318731|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97|||<|0.001|TWO_SIDED|95.0|-2.79|-1.15|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline values as covariate.||||-1.15|-2.79|<0.001
73892826|NCT01305577|147318732|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Pearson's chi-square test|||||||<0.001
73892827|NCT01305577|147318732|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Pearson's chi-square test|||||||<0.001
73892828|NCT03001817|147318773|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892829|NCT03001817|147318774|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892830|NCT03001817|147318775|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann Method|||||||<0.0001
73892831|NCT03001817|147318776|SUPERIORITY|||||||0.5443|||||||Hodges-Lehmann method|||||||0.5443
73892832|NCT03001817|147318777|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann Method|||||||<0.0001
73892833|NCT03001817|147318778|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892834|NCT03001817|147318779|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892835|NCT03001817|147318780|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892836|NCT03001817|147318781|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892837|NCT03001817|147318782|SUPERIORITY|||||||0.4939|||||||Hodges-Lehmann method|||||||0.4939
73892838|NCT03001817|147318783|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892839|NCT03001817|147318784|SUPERIORITY|||||||0.8371|||||||Hodges-Lehmann method|||||||0.8371
73892840|NCT03001817|147318785|SUPERIORITY|||||||0.3415|||||||Hodges-Lehmann method|||||||0.3415
73798909|NCT03718832|147145610|SUPERIORITY||Mean Difference (Net)|0.9013876|STANDARD_ERROR_OF_MEAN|0.4414753||0.0417413|TWO_SIDED|95.0|0.0338441|1.768931||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.768931|0.0338441|0.0417413
73798910|NCT03718832|147145610|SUPERIORITY||Mean Difference (Net)|0.8939751|STANDARD_ERROR_OF_MEAN|0.3896126||0.0222222|TWO_SIDED|95.0|0.1282798|1.65967||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.65967|0.1282798|0.0222222
73798911|NCT03718832|147145610|SUPERIORITY||Mean Difference (Net)|0.0276596|STANDARD_ERROR_OF_MEAN|0.7606961||0.9710103|TWO_SIDED|95.0|-1.467185|1.522504||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||1.522504|-1.467185|0.9710103
73798912|NCT03718832|147145610|SUPERIORITY||Mean Difference (Net)|0.0377244|STANDARD_ERROR_OF_MEAN|0.6523585||0.9539117|TWO_SIDED|95.0|-1.244338|1.319787||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1.319787|-1.244338|0.9539117
73798913|NCT03718832|147145611|SUPERIORITY||Mean Difference (Net)|-0.1045328|STANDARD_ERROR_OF_MEAN|0.1417549||0.4612408|TWO_SIDED|95.0|-0.3830955|0.1740299||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.1740299|-0.3830955|0.4612408
73892841|NCT03001817|147318786|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892842|NCT03001817|147318787|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892843|NCT03001817|147318788|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892844|NCT03001817|147318789|SUPERIORITY|||||||0.7442|||||||Hodges-Lehmann method|||||||0.7442
73892845|NCT03001817|147318790|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73892846|NCT03001817|147318791|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73798914|NCT03718832|147145611|SUPERIORITY||Mean Difference (Net)|-0.0552724|STANDARD_ERROR_OF_MEAN|0.1181649||0.6401864|TWO_SIDED|95.0|-0.2874987|0.176954||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.176954|-0.2874987|0.6401864
73798915|NCT03718832|147145611|SUPERIORITY||Mean Difference (Net)|-0.2761332|STANDARD_ERROR_OF_MEAN|0.2593125||0.2874913|TWO_SIDED|95.0|-0.7857084|0.2334419||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.2334419|-0.7857084|0.2874913
73798916|NCT03718832|147145611|SUPERIORITY||Mean Difference (Net)|-0.155843|STANDARD_ERROR_OF_MEAN|0.2092772||0.4568601|TWO_SIDED|95.0|-0.56713|0.2554439||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.2554439|-0.56713|0.4568601
73798917|NCT03718832|147145612|SUPERIORITY||Mean Difference (Net)|0.0539315|STANDARD_ERROR_OF_MEAN|0.0267347||0.0442418|TWO_SIDED|95.0|0.0013953|0.1064678||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.1064678|0.0013953|0.0442418
73798918|NCT03718832|147145612|SUPERIORITY||Mean Difference (Net)|0.0546574|STANDARD_ERROR_OF_MEAN|0.0272506||0.0454857|TWO_SIDED|95.0|0.0011025|0.1082124||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.1082124|0.0011025|0.0454857
73798919|NCT03718832|147145612|SUPERIORITY||Mean Difference (Net)|0.0076781|STANDARD_ERROR_OF_MEAN|0.0188378||0.683764|TWO_SIDED|95.0|-0.0293401|0.0446963||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0446963|-0.0293401|0.683764
73892847|NCT03001817|147318792|SUPERIORITY|||||||0.0374|||||||Hodges-Lehmann method|||||||0.0374
73892848|NCT03001817|147318793|SUPERIORITY|||||||0.7429|||||||Hodges-Lehmann method|||||||0.7429
73892849|NCT03001817|147318794|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73798920|NCT03718832|147145612|SUPERIORITY||Mean Difference (Net)|0.0053342|STANDARD_ERROR_OF_MEAN|0.0183059||0.7708852|TWO_SIDED|95.0|-0.0306419|0.0413103||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0413103|-0.0306419|0.7708852
73798921|NCT03718832|147145613|SUPERIORITY||Mean Difference (Net)|-0.053099|STANDARD_ERROR_OF_MEAN|0.0436586||0.2245167|TWO_SIDED|95.0|-0.1388926|0.0326946||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0326946|-0.1388926|0.2245167
73798922|NCT03718832|147145613|SUPERIORITY||Mean Difference (Net)|-0.0815933|STANDARD_ERROR_OF_MEAN|0.0424438||0.0551913|TWO_SIDED|95.0|-0.1650069|0.0018204||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.0018204|-0.1650069|0.0551913
73798923|NCT03718832|147145613|SUPERIORITY||Mean Difference (Net)|-0.0506938|STANDARD_ERROR_OF_MEAN|0.0461078||0.2721373|TWO_SIDED|95.0|-0.1413002|0.0399126||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0399126|-0.1413002|0.2721373
73798924|NCT03718832|147145613|SUPERIORITY||Mean Difference (Net)|-0.079563|STANDARD_ERROR_OF_MEAN|0.0428514||0.0640071|TWO_SIDED|95.0|-0.1637776|0.0046516||Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0046516|-0.1637776|0.0640071
73798925|NCT03718832|147145614|SUPERIORITY||Mean Difference (Net)|13.79692|STANDARD_ERROR_OF_MEAN|808.862||0.9864081|TWO_SIDED|95.0|-1581.244|1608.838||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1608.838|-1581.244|0.9864081
73798926|NCT03718832|147145614|SUPERIORITY||Mean Difference (Net)|119.3302|STANDARD_ERROR_OF_MEAN|885.2058||0.8929133|TWO_SIDED|95.0|-1627.128|1865.789||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1865.789|-1627.128|0.8929133
73798927|NCT03718832|147145614|SUPERIORITY||Mean Difference (Net)|-1260.452|STANDARD_ERROR_OF_MEAN|1327.743||0.343724|TWO_SIDED|95.0|-3880.298|1359.393||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||1359.393|-3880.298|0.343724
73798928|NCT03718832|147145614|SUPERIORITY||Mean Difference (Net)|-1206.216|STANDARD_ERROR_OF_MEAN|1344.574||0.3709654|TWO_SIDED|95.0|-3860.887|1448.455||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1448.455|-3860.887|0.3709654
73892850|NCT03001817|147318795|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73892851|NCT03001817|147318796|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73798929|NCT03718832|147145615|SUPERIORITY||Mean Difference (Net)|1290.605|STANDARD_ERROR_OF_MEAN|732.2306||0.0795087|TWO_SIDED|95.0|-153.3215|2734.532||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2734.532|-153.3215|0.0795087
73798930|NCT03718832|147145615|SUPERIORITY||Mean Difference (Net)|1207.762|STANDARD_ERROR_OF_MEAN|874.6068||0.1689786|TWO_SIDED|95.0|-517.7854|2933.309||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2933.309|-517.7854|0.1689786
73798931|NCT03718832|147145615|SUPERIORITY||Mean Difference (Net)|1209.35|STANDARD_ERROR_OF_MEAN|957.1006||0.2080145|TWO_SIDED|95.0|-679.1596|3097.86||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||3097.86|-679.1596|0.2080145
73798932|NCT03718832|147145615|SUPERIORITY||Mean Difference (Net)|1258.587|STANDARD_ERROR_OF_MEAN|1077.807||0.2445904|TWO_SIDED|95.0|-869.3893|3386.563||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||3386.563|-869.3893|0.2445904
73798933|NCT03718832|147145616|SUPERIORITY||Mean Difference (Net)|2.035245|STANDARD_ERROR_OF_MEAN|0.1415551|<|0.001|TWO_SIDED|95.0|1.757075|2.313415||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.313415|1.757075|<0.001
73798934|NCT03718832|147145616|SUPERIORITY||Mean Difference (Net)|2.0087|STANDARD_ERROR_OF_MEAN|0.1395364|<|0.001|TWO_SIDED|95.0|1.734473|2.282927||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2.282927|1.734473|<0.001
73798935|NCT03718832|147145616|SUPERIORITY||Mean Difference (Net)|1.619982|STANDARD_ERROR_OF_MEAN|0.2663507|<|0.001|TWO_SIDED|95.0|1.096575|2.143388||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||2.143388|1.096575|<0.001
73892852|NCT03001817|147318797|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73892853|NCT03001817|147318798|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73798936|NCT03718832|147145616|SUPERIORITY||Mean Difference (Net)|1.559642|STANDARD_ERROR_OF_MEAN|0.2680774|<|0.001|TWO_SIDED|95.0|1.032797|2.086488||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||2.086488|1.032797|<0.001
73798937|NCT03718832|147145617|SUPERIORITY||Mean Difference (Net)|1.881776|STANDARD_ERROR_OF_MEAN|0.1057965|<|0.001|TWO_SIDED|95.0|1.673875|2.089677||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||2.089677|1.673875|<0.001
73798938|NCT03718832|147145617|SUPERIORITY||Mean Difference (Net)|1.868221|STANDARD_ERROR_OF_MEAN|0.1036609|<|0.001|TWO_SIDED|95.0|1.664499|2.071943||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||2.071943|1.664499|<0.001
73798939|NCT03718832|147145617|SUPERIORITY||Mean Difference (Net)|1.650879|STANDARD_ERROR_OF_MEAN|0.2057239|<|0.001|TWO_SIDED|95.0|1.246611|2.055147||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||2.055147|1.246611|<0.001
73798940|NCT03718832|147145617|SUPERIORITY||Mean Difference (Net)|1.636306|STANDARD_ERROR_OF_MEAN|0.2052192|<|0.001|TWO_SIDED|95.0|1.232994|2.039618||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||2.039618|1.232994|<0.001
73798941|NCT03718832|147145618|SUPERIORITY||Mean Difference (Net)|0.1104533|STANDARD_ERROR_OF_MEAN|0.0769621||0.1519153|TWO_SIDED|95.0|-0.040785|0.2616915||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||0.2616915|-0.040785|0.1519153
73798942|NCT03718832|147145618|SUPERIORITY||Mean Difference (Net)|0.0594575|STANDARD_ERROR_OF_MEAN|0.0654489||0.3641254|TWO_SIDED|95.0|-0.0691675|0.1880824||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||0.1880824|-0.0691675|0.3641254
73798943|NCT03718832|147145618|SUPERIORITY||Mean Difference (Net)|0.2062905|STANDARD_ERROR_OF_MEAN|0.1288363||0.1100186|TWO_SIDED|95.0|-0.0468859|0.4594669||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||0.4594669|-0.0468859|0.1100186
73798944|NCT03718832|147145618|SUPERIORITY||Mean Difference (Net)|0.1162375|STANDARD_ERROR_OF_MEAN|0.1015839||0.2531303|TWO_SIDED|95.0|-0.0834025|0.3158775||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||0.3158775|-0.0834025|0.2531303
73798945|NCT03718832|147145619|SUPERIORITY||Mean Difference (Net)|-0.0584644|STANDARD_ERROR_OF_MEAN|0.040837||0.152918|TWO_SIDED|95.0|-0.1387132|0.0217844||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0217844|-0.1387132|0.152918
73798946|NCT03718832|147145619|SUPERIORITY||Mean Difference (Net)|-0.0585771|STANDARD_ERROR_OF_MEAN|0.0304262||0.0548344|TWO_SIDED|95.0|-0.1183728|0.0012186||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||0.0012186|-0.1183728|0.0548344
73892854|NCT03001817|147318799|SUPERIORITY|||||||0.3669|||||||Hodges-Lehmann method|||||||0.3669
73892855|NCT03001817|147318800|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73798947|NCT03718832|147145619|SUPERIORITY||Mean Difference (Net)|-0.1691027|STANDARD_ERROR_OF_MEAN|0.0673022||0.0123238|TWO_SIDED|95.0|-0.3013583|-0.036847||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||-0.036847|-0.3013583|0.0123238
73798948|NCT03718832|147145619|SUPERIORITY||Mean Difference (Net)|-0.1701425|STANDARD_ERROR_OF_MEAN|0.0575065||0.0032534|TWO_SIDED|95.0|-0.2831584|-0.0571266||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||-0.0571266|-0.2831584|0.0032534
73798949|NCT03503669|147145636|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73798950|NCT03503669|147145637|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
73798951|NCT03503669|147145638|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73798952|NCT03503669|147145639|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73798953|NCT03503669|147145640|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73798954|NCT00276484|147145651|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-19.4|-13.2|||ANCOVA|Model terms: treatment and baseline LDL-C value||||-13.2|-19.4|<0.001
73798955|NCT00276484|147145652|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.551||95.0|-1.1|2.1|||ANCOVA|Model terms: treatment and baseline HDL-C value||||2.1|-1.1|0.551
73798956|NCT00276484|147145653|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-17.1|-11.6|||ANCOVA|Model terms: treatment and baseline non-HDL-C value||||-11.6|-17.1|<0.001
73798957|NCT00276484|147145654|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-12.0|-7.9|||ANCOVA|Model terms: treatment and baseline Total-C value||||-7.9|-12.0|<0.001
73798958|NCT00276484|147145655|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-7.3|||<|0.001||95.0|-11.5|-3.1|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.|||-3.1|-11.5|<0.001
73798959|NCT00276484|147145656|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|-12.7|-7.6|||ANCOVA|Model terms: treatment and baseline Apo B value||||-7.6|-12.7|<0.001
73798960|NCT00276484|147145657|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.313||95.0|-0.8|2.5|||ANCOVA|Model terms: treatment and baseline Apo A-I value||||2.5|-0.8|0.313
73798961|NCT00276484|147145658|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-12.6|-8.2|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value||||-8.2|-12.6|<0.001
73798962|NCT00276484|147145659|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-19.9|-13.1|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value||||-13.1|-19.9|<0.001
73798963|NCT00276484|147145660|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-13.8|-8.2|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value||||-8.2|-13.8|<0.001
73798964|NCT00276484|147145661|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.5|STANDARD_ERROR_OF_MEAN|-1.6|<|0.001||95.0|-17.7|-11.3|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value||||-11.3|-17.7|<0.001
73798965|NCT00276484|147145662|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8||||0.174||95.0|-17.1|3.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment.|Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.|||3.4|-17.1|0.174
73798966|NCT00276484|147145663|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.37|||<|0.001||95.0|5.45|12.84|||Regression, Logistic|Model terms: treatment and baseline LDL-C value||||12.84|5.45|<0.001
73798967|NCT02414958|147145675|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.66|-0.41|||Mixed effect Model Repeated Measures||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model Mixed effect Model Repeated Measures (MMRM) included the fixed categorical effects of treatment, pre-existing insulin therapy, visit , and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline estimated glomerular filtration rate (eGFR), and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.41|-0.66|<0.0001
73798968|NCT02414958|147145675|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.66|-0.41|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|Model MMRM included the fixed categorical effects of treatment, pre-existing insulin therapy, visit, and treatment-by- visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline eGFR, and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.41|-0.66|<0.0001
73798969|NCT02414958|147145676|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.65|-0.4|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.40|-0.65|<0.0001
73798970|NCT02414958|147145676|SUPERIORITY||Mean Difference (Final Values)|-0.51|||<|0.0001|TWO_SIDED|97.5|-0.64|-0.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements||-0.39|-0.64|<0.0001
73798971|NCT02414958|147145677|SUPERIORITY||Adjusted Rate Ratio (%)|0.744||||0.0623|TWO_SIDED|97.75|0.518|1.069|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.069|0.518|0.0623
73798972|NCT02414958|147145677|SUPERIORITY||Adjusted Rate Ratio (%)|0.726||||0.048|TWO_SIDED|97.75|0.502|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset||1.501|0.502|0.0480
73798973|NCT02414958|147145677|SUPERIORITY||Adjusted Rate Ratio (%)|0.774||||0.0972|TWO_SIDED|95.0|0.572|1.048||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.048|0.572|0.0972
73798974|NCT02414958|147145677|SUPERIORITY||Adjusted Rate Ratio (%)|0.782||||0.118|TWO_SIDED|97.75|0.575|1.064||Negative binomial model|MMRM||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.064|0.575|0.1180
73798975|NCT02414958|147145678|SUPERIORITY||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|99.75|-3.57|-1.8|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.80|-3.57|<0.0001
73798976|NCT02414958|147145678|SUPERIORITY||Mean Difference (Final Values)|-3.27|||<|0.0001|TWO_SIDED|99.75|-4.15|-2.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.39|-4.15|<0.0001
73798977|NCT02414958|147145679|SUPERIORITY||Mean Difference (Final Values)|11.86|||<|0.0001|TWO_SIDED|99.75|8.78|14.93|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|The analysis of covariance (ANCOVA) model includes baseline time in the target range, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||14.93|8.78|<0.0001
73892856|NCT03001817|147318801|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73892857|NCT03001817|147318802|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73798978|NCT02414958|147145679|SUPERIORITY||Mean Difference (Final Values)|12.87|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|99.75|9.81|15.93|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|||15.93|9.81|<0.0001
73798979|NCT02414958|147145680|SUPERIORITY||Mean Difference (Final Values)|-16.92|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|99.75|-22.04|-11.81|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||-11.81|-22.04|<0.0001
73798980|NCT02414958|147145680|SUPERIORITY||Mean Difference (Final Values)|-19.04|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|99.75|-24.13|-13.95|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||-13.95|-24.13|<0.0001
73798981|NCT02414958|147145681|SUPERIORITY||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|99.75|-0.121|-0.063|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.063|-0.121|<0.0001
73798982|NCT02414958|147145681|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|99.75|-0.119|-0.062|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.062|-0.119|<0.0001
73798983|NCT02414958|147145682|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.0||0.0397|TWO_SIDED|99.75|-5.2|1.0|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model MMRM includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||1.0|-5.2|0.0397
73892858|NCT03001817|147318803|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73892859|NCT03001817|147318804|SUPERIORITY|||||||0.0509|||||||Hodges-Lehmann method|||||||0.0509
73892860|NCT03001817|147318805|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73892861|NCT03001817|147318806|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73798984|NCT02414958|147145682|SUPERIORITY||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|1.0||0.0003|TWO_SIDED|99.75|-6.8|-0.6|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.6|-6.8|0.0003
73798985|NCT02414958|147145682|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.7||0.0457|TWO_SIDED|99.75|-2.7|0.0||Nominal p-value|MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline eGFR baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.0|-2.7|0.0457
73798986|NCT02414958|147145682|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.7||0.0006|TWO_SIDED|99.75|-4.3|-0.3|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.3|-4.3|0.0006
73798987|NCT00619060|147145708|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||Binomial|||||||0.01
73798988|NCT01808573|147145712|SUPERIORITY||Hazard Ratio (HR)|0.762||||0.0059|TWO_SIDED|95.0|0.626|0.926|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib Plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|||0.926|0.626|0.0059
73798989|NCT01808573|147145713|SUPERIORITY||Hazard Ratio (HR)|0.881||||0.2086|TWO_SIDED|95.0|0.723|1.073|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|||1.073|0.723|0.2086
73798990|NCT01808573|147145714|SUPERIORITY|||||||0.043|||||||Gray's test|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral disease.||||||0.043
73892862|NCT03001817|147318807|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73798991|NCT01808573|147145715|SUPERIORITY|||||||0.1201|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.||||||0.1201
73798992|NCT01808573|147145716|SUPERIORITY|||||||0.0328|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.||||||0.0328
73798993|NCT01808573|147145717|SUPERIORITY||Hazard Ratio (HR)|0.495||||0.0004|TWO_SIDED|95.0|0.332|0.736|||Log Rank||Lapatinib Plus Capecitabine is the reference.|||0.736|0.332|0.0004
73798994|NCT03953612|147145740|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Linear mixed effects||||||<.001
73798995|NCT03953612|147145741|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Linear mixed effects||||||<.001
73798996|NCT03953612|147145742|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Linear mixed effects||||||0.7
73798997|NCT03953612|147145743|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
73798998|NCT03953612|147145744|SUPERIORITY|||||||0.042|||||||. Negative binomial regression models|||||||0.042
73798999|NCT03953612|147145745|SUPERIORITY|||||||0.125|||||||. Negative binomial regression models|||||||0.125
73799000|NCT02028676|147145747|NON_INFERIORITY_OR_EQUIVALENCE|Upper 95% confidence interval for the hazard ratio was 1.64, see other analysis for this endpoint for details|Hazard Ratio (HR)|1.13||||0.59|TWO_SIDED|95.0|0.73|1.73|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.73|0.73|0.59
73799001|NCT02028676|147145747|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions detailed above, \>90% power and one-sided alpha=0.05, 1160 children would be required to exclude an increase in progression rate of 1.6% from 2.5% to 4.1% per year in the CDM arm (upper 95% confidence limit of LCM: CDM hazard ratio 1.64).|Risk Difference (RD)|0.32||||0.43|TWO_SIDED|95.0|-0.47|1.12|||Comparison of poisson rates|Statistical analysis plan specified that p-value was to be calculated from the log-rank test, so not provided for the risk difference|Difference is CDM minus LCM|"Assumptions:~* control group (LCM) event rate 3% per year~* rates are reduced to 2% per year in the best of the induction-maintenance arms leading to an overall rate of progression to new WHO stage 4 or death of 2.5%~* recruitment is over 1.5 years and follow-up for a minimum further 3.5 years.~* cumulative loss to follow-up is 10% at 5 years. See below for rest of sample size as this box is not big enough."||1.12|-0.47|0.43
73799002|NCT02028676|147145748|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.83|TWO_SIDED|95.0|0.83|1.16|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.16|0.83|0.83
73799003|NCT02028676|147145749|SUPERIORITY_OR_OTHER|||||||0.33|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||Assuming a standard deviation for the change in CD4 percentage from baseline to 72 weeks of 10% (slightly higher than that observed in the PENTA 5 trial) 1200 children would provide at least 80% power to detect a difference in change in CD4% from baseline of more than 2.5% across the 3 groups (F-test with 2-sided alpha=0.05) assuming 20% missing data (loss to follow-up during the first year plus failure to attend the week 72 visit/missing sample).||||0.33
73799004|NCT02028676|147145750|SUPERIORITY_OR_OTHER|||||||0.69|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.69
73799005|NCT02028676|147145751|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.0001
73799006|NCT02028676|147145751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.01|TWO_SIDED|95.0|1.07|1.63|||Regression, Cox||HR is Arm B vs A|||1.63|1.07|0.01
73892863|NCT03001817|147318808|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73892864|NCT03001817|147318809|SUPERIORITY|||||||0.0647|||||||Hodges-Lehmann method|||||||0.0647
73799007|NCT02028676|147145751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58|||<|0.001|TWO_SIDED|95.0|1.29|1.94|||Regression, Cox|||||1.94|1.29|<0.001
73799008|NCT02028676|147145752|NON_INFERIORITY_OR_EQUIVALENCE|631 children would be required to exclude a 12% lower suppression rate in the once daily group with at least 90% power and two-sided alpha=0.05 (lower 95% confidence limit of difference between once and twice daily -12%, the non-inferiority margin). 630 children retains at least 80% (rather than 90%) power to exclude a 10% (rather than 12%) lower suppression rate in the once daily group with one-sided alpha=0.05 (lower 90% confidence limit of difference between once and twice daily -10%).|Risk Difference (RD)|-1.6||||0.65|TWO_SIDED|95.0|-8.4|5.2|||Chi-squared||Difference in suppression \<80 copies/ml in once-daily minus twice-daily|||5.2|-8.4|0.65
73799009|NCT02028676|147145754|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Hazard Ratio (HR)|1.64||||0.007|TWO_SIDED|95.0|1.14|2.37|||Log Rank||Hazard ratio is stop vs continue.|"Assumptions~* 5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~* recruitment starts 1 July 2009 with 10% children (those already on ART for \>96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~* cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough"||2.37|1.14|0.007
73799010|NCT02028676|147145754|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Risk Difference (RD)|4.0||||0.006|TWO_SIDED|95.0|0.8|7.2|||Poisson regression for risk difference||Risk difference is stop vs continue.|"Assumptions~* 5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~* recruitment starts 1 July 2009 with 10% children (those already on ART for \>96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~* cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough."||7.2|0.8|0.006
73799011|NCT02028676|147145755|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.33|TWO_SIDED|95.0|0.83|1.72|||Log Rank||Hazard ratio is stop vs continue.|||1.72|0.83|0.33
73799012|NCT02028676|147145756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.45|TWO_SIDED|95.0|0.49|1.44|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.44|0.49|0.45
73799013|NCT02028676|147145756|SUPERIORITY_OR_OTHER|||||||0.43|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.43
73892865|NCT03001817|147318810|SUPERIORITY|||||||0.0007|||||||Hodges-Lehmann method|||||||0.0007
73892866|NCT03001817|147318811|SUPERIORITY|||||||0.1399|||||||Hodges-Lehmann method|||||||0.1399
73799014|NCT02028676|147145756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.23|TWO_SIDED|95.0|0.33|1.31|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.31|0.33|0.23
73799015|NCT02028676|147145756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.93|TWO_SIDED|95.0|0.52|1.81|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.81|0.52|0.93
73799016|NCT02028676|147145757|SUPERIORITY_OR_OTHER|||||||0.89|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.89
73799017|NCT02028676|147145757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.64|TWO_SIDED|95.0|0.53|1.48|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.48|0.53|0.64
73799018|NCT02028676|147145757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.71|TWO_SIDED|95.0|0.54|1.52|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.52|0.54|0.71
73799019|NCT02028676|147145758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.73|1.38|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.38|0.73|0.98
73799020|NCT02028676|147145758|SUPERIORITY_OR_OTHER|||||||0.44|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.44
73799021|NCT02028676|147145758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.3|TWO_SIDED|95.0|0.55|1.2|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.20|0.55|0.30
73799022|NCT02028676|147145758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.24|TWO_SIDED|95.0|0.54|1.17|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.17|0.54|0.24
73799023|NCT02028676|147145759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.52|TWO_SIDED|95.0|0.82|1.49|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM.|||1.49|0.82|0.52
73799024|NCT02028676|147145759|SUPERIORITY_OR_OTHER|||||||0.34||||||Global test with 2df, adjusted for randomization stratification factors|Log Rank|||||||0.34
73799025|NCT02028676|147145759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.19|TWO_SIDED|95.0|0.54|1.13|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.13|0.54|0.19
73799026|NCT02028676|147145759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.25|TWO_SIDED|95.0|0.56|1.16|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.16|0.56|0.25
73799027|NCT02028676|147145760|SUPERIORITY_OR_OTHER|||||||0.71|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.71
73799028|NCT02028676|147145760|SUPERIORITY_OR_OTHER|||||||0.58|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.58
73799029|NCT02028676|147145761|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.07
73892867|NCT03001817|147318812|SUPERIORITY|||||||0.0122|||||||Hodges-Lehmann method|||||||0.0122
73892868|NCT03001817|147318813|SUPERIORITY|||||||0.0994|||||||Hodges-Lehmann method|||||||0.0994
73892869|NCT03001817|147318814|SUPERIORITY|||||||0.0904|||||||Hodges-Lehmann method|||||||0.0904
73799030|NCT02028676|147145761|SUPERIORITY_OR_OTHER|||||||0.9|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.90
73799031|NCT02028676|147145762|SUPERIORITY_OR_OTHER|||||||0.64|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.64
73799032|NCT02028676|147145762|SUPERIORITY_OR_OTHER|||||||0.3|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.30
73799033|NCT02028676|147145763|SUPERIORITY_OR_OTHER|||||||0.45|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.45
73799034|NCT02028676|147145764|SUPERIORITY_OR_OTHER|||||||0.7|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.70
73799035|NCT02028676|147145765|SUPERIORITY_OR_OTHER|||||||0.59||0.0|||||Regression, Linear|Adjusted for randomization stratification factors||||||0.59
73799036|NCT02028676|147145765|SUPERIORITY_OR_OTHER|||||||0.01|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.01
73892870|NCT03001817|147318815|SUPERIORITY|||||||0.4346|||||||non-parametric Hodges-Lehmann method|||||||0.4346
73892871|NCT03001817|147318816|SUPERIORITY|||||||0.1474|||||||non-parametric Hodges-Lehmann method|||||||0.1474
73892872|NCT03001817|147318817|SUPERIORITY|||||||0.0054|||||||non-parametric Hodges-Lehmann method|||||||0.0054
73892873|NCT03001817|147318818|SUPERIORITY|||||||0.0002|||||||Hodges-Lehmann method|||||||0.0002
73799037|NCT02028676|147145766|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.81
73799038|NCT02028676|147145766|SUPERIORITY_OR_OTHER|||||||0.03|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.03
73799039|NCT02028676|147145767|SUPERIORITY_OR_OTHER|||||||0.86|||||||Chi-squared|||||||0.86
73799040|NCT02028676|147145767|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
73799041|NCT02028676|147145768|SUPERIORITY_OR_OTHER|||||||0.2|||||||Chi-squared|||||||0.20
73799042|NCT02028676|147145768|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
73799043|NCT02028676|147145769|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.22|TWO_SIDED|95.0|0.48|1.29|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.29|0.48|0.22
73799044|NCT02028676|147145770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.672||||0.09|TWO_SIDED|95.0|0.42|1.075|||Log Rank||Hazard ratio is CDM vs LCM|||1.075|0.420|0.09
73799045|NCT02028676|147145770|SUPERIORITY_OR_OTHER|||||||0.04|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.04
73799046|NCT02028676|147145770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.16||||0.017|TWO_SIDED|95.0|1.15|4.08|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||4.08|1.15|0.017
73799047|NCT02028676|147145770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.034|TWO_SIDED|95.0|1.05|3.8|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||3.80|1.05|0.034
73799048|NCT02028676|147145771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.04|TWO_SIDED|95.0|1.02|1.66|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.66|1.02|0.04
73799049|NCT02028676|147145771|SUPERIORITY_OR_OTHER|||||||0.53|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.53
73799050|NCT02028676|147145771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6|TWO_SIDED|95.0|0.68|1.25|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.25|0.68|0.60
73799051|NCT02028676|147145771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.56|TWO_SIDED|95.0|0.81|1.46|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.46|0.81|0.56
73799052|NCT02028676|147145772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.84|TWO_SIDED|95.0|0.58|1.56|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.56|0.58|0.84
73799053|NCT02028676|147145772|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.002
73799054|NCT02028676|147145772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.8||||0.001|TWO_SIDED|95.0|1.74|8.29|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||8.29|1.74|0.001
73799055|NCT02028676|147145772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.09||||0.006|TWO_SIDED|95.0|1.39|6.85|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||6.85|1.39|0.006
73799056|NCT02028676|147145773|SUPERIORITY_OR_OTHER|||||||0.53|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.53
73799057|NCT02028676|147145773|SUPERIORITY_OR_OTHER|||||||0.46|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.46
73799058|NCT02028676|147145774|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.3||||0.52|TWO_SIDED|95.0|-9.3|4.7|||Chi-squared|||||4.7|-9.3|0.52
73799059|NCT02028676|147145775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.39|TWO_SIDED|95.0|-1.2|0.5|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.5|-1.2|0.39
73799060|NCT02028676|147145776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-0.9|0.9|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.9|-0.9|0.98
73799061|NCT02028676|147145777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.12|TWO_SIDED|95.0|-1.9|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.2|-1.9|0.12
73799062|NCT02028676|147145778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.82|TWO_SIDED|95.0|-60.0|76.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||76|-60|0.82
73892874|NCT03001817|147318819|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73892875|NCT03001817|147318820|SUPERIORITY|||||||0.0118|||||||Hodges-Lehmann method|||||||0.0118
73892876|NCT03001817|147318821|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73799063|NCT02028676|147145779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.0||||0.36|TWO_SIDED|95.0|-104.0|38.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||38|-104|0.36
73799064|NCT02028676|147145780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.0||||0.2|TWO_SIDED|95.0|-220.0|46.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||46|-220|0.20
73799065|NCT02028676|147145782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.2|TWO_SIDED|95.0|0.11|1.64|||Log Rank||Hazard ratio is once-daily vs twice-daily|||1.64|0.11|0.20
73799066|NCT02028676|147145783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.51|TWO_SIDED|95.0|0.31|1.77|||Log Rank||Hazard ratio is once-daily vs twice-daily|||1.77|0.31|0.51
73799067|NCT02028676|147145784|SUPERIORITY_OR_OTHER|||||||0.16|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.16
73892877|NCT03001817|147318822|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
73799068|NCT02028676|147145785|SUPERIORITY_OR_OTHER|||||||0.54|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.54
73799069|NCT02028676|147145786|SUPERIORITY_OR_OTHER|||||||0.08|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.08
73799070|NCT02028676|147145787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.82|TWO_SIDED|95.0|0.72|1.52|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily|||1.52|0.72|0.82
73799071|NCT02028676|147145788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.31|TWO_SIDED|95.0|0.48|1.27|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily|||1.27|0.48|0.31
73799072|NCT02028676|147145789|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared|||||||0.74
73799073|NCT02028676|147145790|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
73799074|NCT02028676|147145791|SUPERIORITY_OR_OTHER|||||||0.93|||||||Generalized estimating equations|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.93
73799075|NCT02028676|147145792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.21|||<|0.001|TWO_SIDED|95.0|1.5|3.25|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||3.25|1.50|<0.001
73799076|NCT02028676|147145793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.44|TWO_SIDED|95.0|0.56|3.85|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||3.85|0.56|0.44
73799077|NCT02028676|147145794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.4||||0.03|TWO_SIDED|95.0|1.05|5.48|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||5.48|1.05|0.03
73799078|NCT02028676|147145795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.98||||0.18|TWO_SIDED|95.0|0.44|35.7|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||35.7|0.44|0.18
73799079|NCT02028676|147145796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.34|TWO_SIDED|95.0|0.53|6.17|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||6.17|0.53|0.34
73799080|NCT02028676|147145797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.68|TWO_SIDED|95.0|0.12|4.15|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||4.15|0.12|0.68
73799081|NCT02028676|147145798|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.07
73799082|NCT02028676|147145799|SUPERIORITY_OR_OTHER|||||||0.19|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.19
73799083|NCT02028676|147145800|SUPERIORITY_OR_OTHER|||||||0.34|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.34
73799084|NCT02028676|147145801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.13|TWO_SIDED|95.0|-1.4|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue|||0.2|-1.4|0.13
73799085|NCT02028676|147145802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0||||0.68|TWO_SIDED|95.0|-65.0|42.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue|||42|-65|0.68
73799086|NCT02028676|147145803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.04|TWO_SIDED|95.0|1.02|2.5|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||2.50|1.02|0.04
73799087|NCT02028676|147145804|SUPERIORITY_OR_OTHER|||||||0.21||||||Adjusted for randomization stratification factors|Generalised estimating equation|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.21
73799088|NCT00141778|147145840|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Chi-squared|||Discrete variables were compared among treatment groups with a chi-square test.||||0.95
73799089|NCT00141778|147145841|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
73799090|NCT00141778|147145842|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Chi-squared|||||||0.15
73799091|NCT00141778|147145843|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
73799092|NCT00141778|147145844|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Kruskal-Wallis|||||||0.56
73799093|NCT00141778|147145845|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Kruskal-Wallis|||||||0.15
73799094|NCT00141778|147145846|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Chi-squared|||||||0.38
73799095|NCT00141778|147145847|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Chi-squared|||||||0.65
73892878|NCT03001817|147318823|SUPERIORITY|||||||0.2049|||||||Hodges-Lehmann method|||||||0.2049
73892879|NCT03001817|147318824|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892880|NCT03001817|147318825|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892881|NCT03001817|147318826|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892882|NCT03001817|147318827|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892883|NCT03001817|147318828|SUPERIORITY|||||||0.9117|||||||Hodges-Lehmann method|||||||0.9117
73892884|NCT03001817|147318829|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
73892885|NCT02504216|147318950|SUPERIORITY||Hazard Ratio (HR)|0.85|||=|0.0043|TWO_SIDED|95.0|0.76|0.96|||Log Rank|P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.||IxRS: Interactive web/voice response system||0.96|0.76|=0.0043
73892886|NCT02504216|147318951|OTHER||Hazard Ratio (HR)|1.43|||=|0.0695|TWO_SIDED|95.0|0.97|2.1|||Log Rank|P-value (2-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.||||2.10|0.97|=0.0695
73892887|NCT02504216|147318952|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.0004|TWO_SIDED|95.0|0.71|0.91||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.91|0.71|=0.0004
73892888|NCT02504216|147318953|SUPERIORITY||Hazard Ratio (HR)|0.88|||=|0.014|TWO_SIDED|95.0|0.79|0.99||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.99|0.79|=0.0140
73892889|NCT02504216|147318954|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.62|0.85||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.85|0.62|<0.0001
73892890|NCT02504216|147318955|SUPERIORITY||Hazard Ratio (HR)|0.89|||=|0.0145|TWO_SIDED|95.0|0.79|0.99||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.99|0.79|=0.0145
73892891|NCT02504216|147318956|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.0051|TWO_SIDED|95.0|0.76|0.96||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.96|0.76|=0.0051
73892892|NCT02504216|147318957|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.8322|TWO_SIDED|95.0|0.92|1.27||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||1.27|0.92|=0.8322
73892893|NCT02504216|147318958|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.0235|TWO_SIDED|95.0|0.37|1.0||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||1.00|0.37|=0.0235
73892894|NCT02504216|147318959|OTHER||Hazard Ratio (HR)|1.42|||=|0.0068|TWO_SIDED|95.0|1.1|1.84|||Log Rank|||||1.84|1.10|=0.0068
73892895|NCT02504216|147318960|OTHER||Hazard Ratio (HR)|1.29|||=|0.0979|TWO_SIDED|95.0|0.95|1.76|||Log Rank|||||1.76|0.95|=0.0979
73892896|NCT03237286|147318988|SUPERIORITY|||||||0.0004|||||||Regression, Linear|||||||.0004
73892897|NCT00947882|147319010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0911||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0911
73892898|NCT00947882|147319010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.0865|TWO_SIDED|||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0865
73892899|NCT00947882|147319010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.2342||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.2342
73892900|NCT00947882|147319011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.0367||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Months 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0367
73892901|NCT00947882|147319011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.0231||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0231
73799096|NCT02730663|147145859|NON_INFERIORITY|The number and percentage of patients who achieved clinical success at the time of stent removal are presented. A one-sided 97.5% confidence interval is to be calculated to confirm the degree of non-inferiority for the reference value (96%) and the difference (Investigational device - reference value) and if the lower limit of the confidence interval is -10% or higher, the noninferiority will be considered to be confirmed.|Reference value|-0.07||||0.05|ONE_SIDED|97.5||||A two-tail test was performed for statistics at a significance level of 0.05 unless otherwise specified.|t-test, 2 sided|||The clinical success rate at the time point of stent removal is reported 86.2% according to the approval data of the commercially available AXIOS stent submitted to the US FDA. The clinical success rates of EUS-guided transluminal drainage using a lumen-appending stent were 93.3% (29 cases), 100% (8 cases) and 100% (7 cases) respectively in the studies performed afterwards by Shah RJ (2015), Gornals JB (2012) and Moon JH (2014). The weighted average calculated for each study was about 96%.||||0.05
73799097|NCT01610492|147145879|OTHER||Geometric Mean|0.76|||||TWO_SIDED|95.0|0.57|1.01||||||||1.01|0.57|
73799098|NCT01610492|147145880|OTHER||Geometric Mean|0.27|||||TWO_SIDED|95.0|0.12|0.58||||||||0.58|0.12|
73799099|NCT04211831|147145977|OTHER||Least square mean difference|-1.29|||=|0.1722|TWO_SIDED|95.0|-3.16|0.58|||mixed model for repeated measures||Treatment comparison between Placebo and URO-902 24 mg using least sqaure mean difference and 95% confidence interval (CI) has been presented.|||0.58|-3.16|=0.1722
73799100|NCT04211831|147145977|OTHER||Least Square Mean Difference|-2.24|||=|0.0159|TWO_SIDED|95.0|-4.04|-0.43|||Mixed model for repeated measures||Treatment comparison between Placebo and URO-902 48 mg using least sqaure mean difference and 95% CI has been presented.|||-0.43|-4.04|=0.0159
73799101|NCT01256879|147145979|OTHER|Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC.|||||||||||||||||Bioequivalence testing of AUC, per FDA guidance, is applied. Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC. The upper and lower 90% Confidence Interval for CimTest-A is 104.4% to 120.6%. The upper and lower 90% Confidence Interval for CimTest-B is 97.9% to 113.0%. The upper and lower 90% Confidence Interval for Commercial Cimetidine Solution is 93.2% to 107.7%.|||
73892902|NCT00947882|147319011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.1638||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1638
73892903|NCT00947882|147319011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.1941||||||P-values based on Williams' extended trend test of comparisons vs. placebo at Month 5. No adjustment for multiple comparison was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1941
73892904|NCT00947882|147319011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.1083||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1083
73799102|NCT05287230|147146059|OTHER|||||||0.061||||||A priori threshold for statistical significance is p\<0.05.|ANOVA|||||||0.061
73799103|NCT05525520|147146081|EQUIVALENCE|two-sided equivalence test|Least square mean difference (LSMD)|0.46|STANDARD_ERROR_OF_MEAN|0.609||0.4577|TWO_SIDED|95.0|-0.77|1.68|||MMRM|Treatment, type of cholestatic disease, week, and treatment-by-week interaction were fixed effects, and Baseline WI-NRS score was a covariate.|LSMD=EP547 minus placebo|||1.68|-0.77|0.4577
73799104|NCT03657797|147146099|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-0.4||||0.2666|TWO_SIDED|95.0|-1.11|0.31||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 470 0.21% was compared to latanoprost.||0.31|-1.11|0.2666
73799105|NCT03657797|147146099|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-0.81||||0.0281|TWO_SIDED|95.0|-1.52|-0.09||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 0.042% was compared to latanoprost.||-0.09|-1.52|0.0281
73799106|NCT03657797|147146099|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-1.23||||0.0009|TWO_SIDED|95.0|-1.96|-0.51||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 0.065% was compared to latanoprost.||-0.51|-1.96|0.0009
73799107|NCT03657797|147146100|NON_INFERIORITY|NCX 470 0.021% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.9788||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were 0.51 (week 1), 0.68 (week 2), 0.75 (exit visit); p-values were 0.5560 (week 1), 0.9788 (week 2), 0.8796 (exit visit)||NCX 470 0.021% was compared to latanoprost.||||<0.9788
73799108|NCT03657797|147146100|NON_INFERIORITY|NCX 470 0.042% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.3863||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were 0.20 (week 1), 0.38 (week 2), 0.11 (exit visit); p-values were 0.1556 (week 1), 0.3863 (week 2), 0.0912 (exit visit)||NCX 470 0.042% was compared to latanoprost.||||<0.3863
73799109|NCT03657797|147146100|NON_INFERIORITY|NCX 470 0.065% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.0174||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were -0.35 (week 1), -0.15 (week 2), -0.27 (exit visit); p-values were 0.0040 (week 1), 0.0174 (week 2), 0.0093 (exit visit)||NCX 470 0.065% was compared to latanoprost.||||<0.0174
73799110|NCT01783990|147146131|SUPERIORITY|||||||0.33|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.33
73799111|NCT01783990|147146132|SUPERIORITY|||||||0.8|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.80
73799112|NCT01783990|147146133|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.87
73799113|NCT01783990|147146134|SUPERIORITY|||||||0.28|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.28
73799114|NCT01783990|147146135|SUPERIORITY|||||||0.31|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.31
73799115|NCT01783990|147146136|SUPERIORITY|||||||0.04|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.04
73799116|NCT02203357|147146142|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0||||The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance.|ANOVA|||||||<0.05
73799117|NCT04055740|147146154|SUPERIORITY|||||||0.2201|||||||Spearman Correlation Coefficient|This test measures correlation of avg ILA grade per patient with total time of lead extraction. Average ILA grade of all patients in outcome measures.||H0: rho = 0 Spearman correlation coefficient calculated between average ILA grade and total time of lead extraction||||0.2201
73799118|NCT04055740|147146154|SUPERIORITY|||||||0.5157|||||||Spearman Correlation Coefficient|This measures correlation of avg ILA grade per patient with total laser pulsations used for extraction. Avg ILA grade of patients in outcome measures.||H0: rho = 0 Spearman Correlation coefficient calculated between average ILA grades and laser pulsations||||0.5157
73799119|NCT01525329|147146156|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.007|||||||t-test, 2 sided|||||||< 0.007
73799120|NCT01525329|147146156|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.080
73799121|NCT01525329|147146157|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73799122|NCT01525329|147146157|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73799123|NCT01958437|147146176|SUPERIORITY|||||||0.048|||||||ANCOVA|||RM ANCOVA (covarying order) for cognitively intact groups||||.048
73799124|NCT01958437|147146176|SUPERIORITY|||||||0.063|||||||ANCOVA|||RM ANCOVA (covarying order) for MCI group||||.063
73799125|NCT01958437|147146177|SUPERIORITY|||||||0.27|||||||ANCOVA|Main effect of stimulation covarying session order||Change between active and sham tDCS sessions for allocentric blocks||||.27
73799126|NCT01958437|147146177|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
73799127|NCT01958437|147146178|SUPERIORITY||||||<|0.001|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order||||||<.001
73799128|NCT01958437|147146178|SUPERIORITY|||||||0.046|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order||||||.046
73799129|NCT01958437|147146179|SUPERIORITY|||||||0.497|||||||ANCOVA|||Repeated Measures ANCOVA (covarying stimulation order)||||.497
73799130|NCT01958437|147146179|SUPERIORITY|||||||0.599|||||||ANCOVA|||||||.599
73799131|NCT04886596|147146188|OTHER|VE is demonstrated if the lower limit (LL) of the 2-sided confidence interval (CI) for vaccine efficacy (VE) is above 20%.|VE|82.58|||||TWO_SIDED|96.95|57.89|94.08|||Poisson regression method||VE in terms of occurrence of RSV-confirmed LRTD was evaluated using the conditional exact binomial method based on the Poisson model|To demonstrate the vaccine efficacy (VE) efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD during the first season in adults ≥ 60 YOA||94.08|57.89|
73799132|NCT04886596|147146189|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|62.91|||||TWO_SIDED|97.5|46.74|74.79|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.||74.79|46.74|
73799133|NCT04886596|147146189|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.18|||||TWO_SIDED|97.5|48.19|80.04|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.||80.04|48.19|
73799134|NCT04886596|147146190|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.76|||||TWO_SIDED|97.5|51.82|79.11|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.||79.11|51.82|
73799135|NCT04886596|147146190|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.12|||||TWO_SIDED|97.5|48.09|80.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.||80.00|48.09|
73799136|NCT04886596|147146191|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|69.83|||||TWO_SIDED|97.5|42.18|85.72|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.||85.72|42.18|
73799137|NCT04886596|147146191|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|58.57|||||TWO_SIDED|97.5|35.9|74.11|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.||74.11|35.90|
73799138|NCT04886596|147146192|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|55.12|||||TWO_SIDED|97.5|16.52|77.52|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.||77.52|16.52|
73799139|NCT04886596|147146192|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|73.58|||||TWO_SIDED|97.5|55.1|85.4|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.||85.40|55.10|
73799140|NCT04886596|147146193|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|18.41|||||TWO_SIDED|95.0|-19.1|44.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season)|To evaluate vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hMPV-confirmed LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine up to the end of Season 1.||44.33|-19.10|
73799141|NCT04886596|147146194|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.78|||||TWO_SIDED|95.0|40.73|71.96|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.96|40.73|
73799142|NCT04886596|147146194|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|65.98|||||TWO_SIDED|95.0|44.32|80.16|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||80.16|44.32|
73799143|NCT04886596|147146194|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|36.24|||||TWO_SIDED|95.0|-93.99|82.47|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||82.47|-93.99|
73892905|NCT00947882|147319011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.2782||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.2782
73892906|NCT00947882|147319011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.1562||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1562
73892907|NCT00947882|147319011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.1736||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1736
73892908|NCT00947882|147319011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.3132||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.3132
73892909|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.2034|TWO_SIDED|95.0|0.814|2.628||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 3."|||2.628|0.814|0.2034
73892910|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.1748|TWO_SIDED|95.0|0.834|2.71||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 3."|||2.710|0.834|0.1748
73892911|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0658|TWO_SIDED|95.0|0.964|3.195||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 3."|||3.195|0.964|0.0658
73892912|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0587|TWO_SIDED|95.0|0.979|3.184||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 4."|||3.184|0.979|0.0587
73892913|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.049|TWO_SIDED|95.0|1.003|3.283||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 4."|||3.283|1.003|0.0490
73892914|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.2742|TWO_SIDED|95.0|0.774|2.464||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 4."|||2.464|0.774|0.2742
73892915|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.4206|TWO_SIDED|95.0|0.706|2.304||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 5."|||2.304|0.706|0.4206
73892916|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.5494|TWO_SIDED|95.0|0.664|2.16||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 5."|||2.160|0.664|0.5494
73892917|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7586|TWO_SIDED|95.0|0.609|1.975||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 5."|||1.975|0.609|0.7586
73892918|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1946|TWO_SIDED|95.0|0.816|2.717||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 6."|||2.717|0.816|0.1946
73799144|NCT04886596|147146194|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|66.56|||||TWO_SIDED|95.0|49.33|78.64|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.64|49.33|
73799145|NCT04886596|147146194|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.25|||||TWO_SIDED|95.0|40.49|79.55|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.||79.55|40.49|
73799146|NCT04886596|147146194|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|32.81|||||TWO_SIDED|95.0|-108.42|81.73|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.||81.73|-108.42|
73799147|NCT04886596|147146195|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|80.64|||||TWO_SIDED|95.0|55.9|92.73|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||92.73|55.90|
73799148|NCT04886596|147146195|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.39|||||TWO_SIDED|95.0|36.44|77.7|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||77.70|36.44|
73799149|NCT04886596|147146195|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|47.15|||||TWO_SIDED|95.0|7.06|71.59|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.59|7.06|
73799150|NCT04886596|147146195|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|54.92|||||TWO_SIDED|95.0|27.85|72.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||72.98|27.85|
73799151|NCT04886596|147146195|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.51|||||TWO_SIDED|95.0|22.35|88.79|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.79|22.35|
73799152|NCT04886596|147146196|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.86|||||TWO_SIDED|95.0|57.62|90.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||90.48|57.62|
73892919|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.538|TWO_SIDED|95.0|0.667|2.174||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 6."|||2.174|0.667|0.5380
73892920|NCT00947882|147319012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.4263|TWO_SIDED|95.0|0.702|2.308||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 6."|||2.308|0.702|0.4263
73799153|NCT04886596|147146196|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.59|||||TWO_SIDED|95.0|34.0|75.1|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||75.10|34.00|
73799154|NCT04886596|147146196|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|47.91|||||TWO_SIDED|95.0|8.51|71.97|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.97|8.51|
73799155|NCT04886596|147146196|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.33|||||TWO_SIDED|95.0|33.59|74.94|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||74.94|33.59|
73799156|NCT04886596|147146196|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|68.4|||||TWO_SIDED|95.0|24.64|89.08|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||89.08|24.64|
73799157|NCT04886596|147146197|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.75|||||TWO_SIDED|95.0|57.95|89.26|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 1.||89.26|57.95|
73799158|NCT04886596|147146197|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.63|||||TWO_SIDED|95.0|52.47|77.95|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following a single dose of the RSVPreF3 OA investigational vaccine.||77.95|52.47|
73799159|NCT04886596|147146197|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.87|||||TWO_SIDED|95.0|46.76|74.11|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following a single dose of the RSVPreF3 OA investigational vaccine.||74.11|46.76|
73799160|NCT04886596|147146197|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.49|||||TWO_SIDED|95.0|52.27|77.86|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.||77.86|52.27|
73799161|NCT04886596|147146197|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.66|||||TWO_SIDED|95.0|51.71|78.34|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.34|51.71|
73799162|NCT04886596|147146198|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|66.49|||||TWO_SIDED|95.0|47.54|79.4|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.||79.40|47.54|
73799163|NCT04886596|147146198|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.88|||||TWO_SIDED|95.0|34.81|74.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.||74.98|34.81|
73892921|NCT00947882|147319013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76||||0.4607|TWO_SIDED|95.0|-10.113|4.59||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|||4.590|-10.113|0.4607
73799164|NCT04886596|147146198|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|72.55|||||TWO_SIDED|95.0|54.34|84.37|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.||84.37|54.34|
73799165|NCT04886596|147146198|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.99|||||TWO_SIDED|95.0|37.17|78.01|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.01|37.17|
73799166|NCT04886596|147146199|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.48|||||TWO_SIDED|95.0|38.62|76.74|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.||76.74|38.62|
73799167|NCT04886596|147146199|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.73|||||TWO_SIDED|95.0|45.1|78.14|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.||78.14|45.10|
73799168|NCT04886596|147146199|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|68.14|||||TWO_SIDED|95.0|45.71|82.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.33|45.71|
73799169|NCT04886596|147146199|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|63.88|||||TWO_SIDED|95.0|31.35|82.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.48|31.35|
73799170|NCT04886596|147146199|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.16|||||TWO_SIDED|95.0|41.08|79.17|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.||79.17|41.08|
73799171|NCT04886596|147146199|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|71.19|||||TWO_SIDED|95.0|51.92|83.65|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.||83.65|51.92|
73892922|NCT00947882|147319013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.24||||0.3876|TWO_SIDED|95.0|-10.614|4.128||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|||4.128|-10.614|0.3876
73892923|NCT00947882|147319013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28||||0.2548|TWO_SIDED|95.0|-11.65|3.096||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|||3.096|-11.650|0.2548
73799172|NCT04886596|147146199|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|75.94|||||TWO_SIDED|95.0|54.11|88.54|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition,following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.54|54.11|
73799173|NCT04886596|147146199|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|69.85|||||TWO_SIDED|95.0|37.51|87.05|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following annual revaccination of the RSVPreF3 OA investigational vaccine.||87.05|37.51|
73799174|NCT04886596|147146200|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-153.57|||||TWO_SIDED|95.0|-16322.97|88.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||88.00|-16322.97|
73799175|NCT04886596|147146200|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|70.07|||||TWO_SIDED|95.0|43.89|85.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||85.33|43.89|
73799176|NCT04886596|147146200|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.04|||||TWO_SIDED|95.0|42.89|74.08|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||74.08|42.89|
73799177|NCT04886596|147146200|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|13.62|||||TWO_SIDED|95.0|-6751.38|98.91|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||98.91|-6751.38|
73799178|NCT04886596|147146200|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|74.32|||||TWO_SIDED|95.0|49.33|88.31|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.31|49.33|
73799179|NCT04886596|147146200|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.79|||||TWO_SIDED|95.0|46.1|77.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||77.75|46.10|
73799180|NCT04886596|147146201|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.38|||||TWO_SIDED|95.0|42.43|82.68|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.68|42.43|
73799181|NCT04886596|147146201|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.38|||||TWO_SIDED|95.0|42.43|82.68|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following a single dose of the RSVPreF3 OA investigational vaccine.||82.68|42.43|
73892924|NCT00947882|147319013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.5652|TWO_SIDED|95.0|-9.729|5.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|||5.322|-9.729|0.5652
73892925|NCT00947882|147319013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.7502|TWO_SIDED|95.0|-8.768|6.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|||6.322|-8.768|0.7502
73892926|NCT00947882|147319013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.6089|TWO_SIDED|95.0|-9.513|5.581||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|||5.581|-9.513|0.6089
73892927|NCT00947882|147319014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.8511|TWO_SIDED|95.0|-1.068|1.294||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|||1.294|-1.068|0.8511
73892928|NCT00947882|147319014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.6331|TWO_SIDED|95.0|-0.9|1.477||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|||1.477|-0.900|0.6331
73892929|NCT00947882|147319014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.909|TWO_SIDED|95.0|-1.113|1.25||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|||1.250|-1.113|0.9090
73892930|NCT00947882|147319014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.5469|TWO_SIDED|95.0|-0.956|1.802||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|||1.802|-0.956|0.5469
73892931|NCT00947882|147319014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.7906|TWO_SIDED|95.0|-1.576|1.2||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|||1.200|-1.576|0.7906
73892932|NCT00947882|147319014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.5757|TWO_SIDED|95.0|-1.773|0.987||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|||0.987|-1.773|0.5757
73892933|NCT00104520|147319019|SUPERIORITY_OR_OTHER|||||||0.007||0.0||||Analysis based on 2-sided test with 0.05 a priori threshold for statistical significance. No adjustments were made for multiple comparisons.|Log Rank|||H0: no difference between AZLI and placebo (pooled treatment groups) in time to need for inhaled or IV antibiotics. Assuming 2-sided significance level of 0.05, \~210 subjects (70 in each AZLI group, 35 in each placebo group) provided \>90% power to reject null hypothesis based on Lakatos normal approximation method with weights being one. Therefore, 250 subjects were to be randomized at Visit 2 (Day -28) to ensure at least 210 participants entered double-blind treatment period at Day 0.||||0.0070
73892934|NCT00104520|147319020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.01||||0.0196|TWO_SIDED|95.0|0.81|9.21||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in change from baseline in CFQ-R RSS scores.||9.21|0.81|0.0196
73799182|NCT04886596|147146201|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|59.16|||||TWO_SIDED|95.0|-119.6|95.93|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to the case definition 2, following a single dose of the RSVPreF3 OA investigational vaccine.||95.93|-119.60|
73799183|NCT04886596|147146201|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.8|||||TWO_SIDED|95.0|57.05|90.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following annual revaccination of the RSVPreF3 OA investigational vaccine.||90.75|57.05|
73892935|NCT00104520|147319021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.28||||0.0012|TWO_SIDED|95.0|2.5|10.06||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in percent change from baseline in FEV1 (L).||10.060|2.500|0.0012
73892936|NCT00104520|147319023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.659||||0.0059|TWO_SIDED|95.0|-1.125|-0.193|||ANCOVA|ANCOVA model included terms for treatment and baseline highest MIC of aztreonam for PA (\<=2, 4-8, 16-128 or \>=256 μg/mL) value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in mean change from baseline in log10 PA CFUs in sputum.||-0.193|-1.125|0.0059
73892937|NCT05188053|147319032|OTHER|"Sample size calculations were performed to estimate the number of subjects needed to detect a 30% difference in NRS pain AUC scores between the study groups.~30% reduction in pain was considered the minimal clinically important difference in pain control based off previous pain research.~A 30% reduction in pain would correspond with a difference of approximately 136 in area under the curve of mean pain over time."||||||0.17||||||a priori threshold p \<0.05|t-test, 2 sided|assuming unequal variance||Two-sample t-test with unequal variance. The null hypothesis is that there was no statistically significant difference between the two treatment groups based on a standard alpha value of 0.05.||||0.170
73892938|NCT00488683|147319163|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.06||||0.69||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||0.69
73892939|NCT00488683|147319163|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.14||||0.3||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||0.30
73892940|NCT00488683|147319163|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.81|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||<0.0001
73892941|NCT00488683|147319163|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.67||||0.001||95.0||||Values from Groups I, II and III were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||0.001
73892942|NCT00488683|147319163|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.08||||0.61||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||0.61
73892943|NCT00488683|147319163|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.31||||0.02||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||0.02
73892944|NCT00488683|147319163|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.45||||0.002||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||0.002
73892945|NCT00488683|147319163|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.4||||0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||0.08
73892946|NCT00488683|147319163|SUPERIORITY_OR_OTHER||R-square|0.004||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||
73799184|NCT04886596|147146201|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.8|||||TWO_SIDED|95.0|57.05|90.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following annual revaccination of the RSVPreF3 OA investigational vaccine.||90.75|57.05|
73892947|NCT00488683|147319163|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||
73892948|NCT00488683|147319163|SUPERIORITY_OR_OTHER||R-square|0.66||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||
73799185|NCT04886596|147146201|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|20.27|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|20.27|
73799186|NCT04886596|147146202|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|51.13|||||TWO_SIDED|95.0|40.31|60.21|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||60.21|40.31|
73892949|NCT00488683|147319163|SUPERIORITY_OR_OTHER||R-square|0.45||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||
73892950|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.07||||0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||0.70
73892951|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.13||||0.37||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||0.37
73799187|NCT04886596|147146202|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.44|||||TWO_SIDED|95.0|48.1|66.96|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||66.96|48.10|
73799188|NCT04886596|147146203|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.33|||||TWO_SIDED|95.0|-1.47|5.99|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||5.99|-1.47|
73799189|NCT04886596|147146203|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|3.32|||||TWO_SIDED|95.0|-0.5|6.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||6.98|-0.50|
73799190|NCT04886596|147146203|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|3.68|||||TWO_SIDED|95.0|-1.55|8.63|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||8.63|-1.55|
73799191|NCT04886596|147146203|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|6.99|||||TWO_SIDED|95.0|1.81|11.9|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||11.90|1.81|
73799192|NCT04886596|147146204|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|50.37|||||TWO_SIDED|95.0|-184.45|95.19|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||95.19|-184.45|
73799193|NCT04886596|147146204|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|50.37|||||TWO_SIDED|95.0|-184.45|95.19|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||95.19|-184.45|
73892952|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.66|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||<0.0001
73892953|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.9|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||<0.0001
73892954|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.01||||0.94||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||0.94
73892955|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||0.70
73892956|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.3||||0.04||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||0.04
73892957|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.46||||0.004||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||0.004
73892958|NCT00488683|147319164|SUPERIORITY_OR_OTHER||R-square|0.005||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||
73892959|NCT00488683|147319164|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||
73892960|NCT00488683|147319164|SUPERIORITY_OR_OTHER||R-square|0.43||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||
73892961|NCT00488683|147319164|SUPERIORITY_OR_OTHER||R-square|0.82||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||
73892962|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.05||||0.68||95.0||||Values from Group 1, 2 and 2 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||0.68
73892963|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.08||||0.46||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||0.46
73892964|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.2||||0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||0.08
73892965|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.45|||<|0.001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||<0.001
73892966|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.04||||0.75||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||0.75
73892967|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.27||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||0.27
73892968|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.07||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||0.07
73892969|NCT00488683|147319164|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.23||||0.06||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||0.06
73892970|NCT00488683|147319164|SUPERIORITY_OR_OTHER||R-square|0.0029||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
73892971|NCT00488683|147319164|SUPERIORITY_OR_OTHER||R-square|0.0059||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
73892972|NCT00488683|147319164|SUPERIORITY_OR_OTHER||R-square|0.04||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
73892973|NCT00488683|147319164|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
73892974|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.26||||0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.46
73892975|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.14||||0.59||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.59
73892976|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.006||||0.98||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.98
73892977|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.24||||0.2||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.20
73892978|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.43||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.08
73892979|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.08||||0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.68
73892980|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.006||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.006
73892981|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.16||||0.48||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.48
73892982|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.26||||0.46||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.46
73892983|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.21||||0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.40
73892984|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.12||||0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.60
73892985|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.4||||0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.03
73892986|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.72||||0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.001
73892987|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.0||||1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||1.00
73892988|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.24
73892989|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.22||||0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.34
73892990|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||
73892991|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||
73892992|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||
73892993|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||
73892994|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||
73892995|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.007||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||
73892996|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.59||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||
73892997|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||
73892998|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.0002||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.0002
73892999|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.03||||0.9||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.90
73893000|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.47||||0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.02
73893001|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.29||||0.12||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.12
73893002|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.31||||0.22||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.22
73893003|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.81|||<|0.0001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||<0.0001
73799194|NCT04886596|147146204|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|11.56|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|11.56|
73799195|NCT04886596|147146204|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|11.56|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|11.56|
73799196|NCT04886596|147146204|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|22.14|||||TWO_SIDED|95.0|-457.67|93.12|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV seson in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||93.12|-457.67|
73799197|NCT04886596|147146204|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|22.14|||||TWO_SIDED|95.0|-457.67|93.12|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||93.12|-457.67|
73799198|NCT04886596|147146204|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|-54.53|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|-54.53|
73799199|NCT04886596|147146204|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|-54.53|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|-54.53|
73799200|NCT04886596|147146205|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-1.81|||||TWO_SIDED|95.0|-25.43|17.49|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||17.49|-25.43|
73799201|NCT04886596|147146205|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-4.72|||||TWO_SIDED|95.0|-28.26|14.61|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||14.61|-28.26|
73799202|NCT04886596|147146205|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-3.61|||||TWO_SIDED|95.0|-28.2|16.38|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine||16.38|-28.20|
73893004|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.15||||0.82||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.82
73893005|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.15||||0.66||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.66
73799203|NCT04886596|147146205|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-3.59|||||TWO_SIDED|95.0|-27.55|15.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||15.98|-27.55|
73799204|NCT04886596|147146205|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.98|||||TWO_SIDED|95.0|-23.52|23.99|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||23.99|-23.52|
73799205|NCT04886596|147146205|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-1.71|||||TWO_SIDED|95.0|-28.56|19.7|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||19.70|-28.56|
73799206|NCT04886596|147146205|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|4.8|||||TWO_SIDED|95.0|-22.14|26.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||26.00|-22.14|
73799207|NCT04886596|147146205|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|4.64|||||TWO_SIDED|95.0|-21.73|25.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||25.48|-21.73|
73799208|NCT04886596|147146206|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.94|||||TWO_SIDED|95.0|28.91|82.15|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||82.15|28.91|
73799209|NCT04886596|147146206|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|63.8|||||TWO_SIDED|95.0|28.5|83.2|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||83.20|28.50|
73799210|NCT04886596|147146206|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|65.69|||||TWO_SIDED|95.0|28.56|85.47|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||85.47|28.56|
73799211|NCT04886596|147146206|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.87|||||TWO_SIDED|95.0|21.45|84.29|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||84.29|21.45|
73799212|NCT04886596|147146207|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.59|||||TWO_SIDED|95.0|-8.29|12.42|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||12.42|-8.29|
73893006|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.51||||0.03||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.03
73799213|NCT04886596|147146207|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|6.7|||||TWO_SIDED|95.0|-4.05|16.39|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||16.39|-4.05|
73799214|NCT04886596|147146207|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|10.95|||||TWO_SIDED|95.0|-0.68|21.31|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||21.31|-0.68|
73799215|NCT04886596|147146207|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|12.12|||||TWO_SIDED|95.0|0.32|22.58|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||22.58|0.32|
73799216|NCT02777372|147146263|OTHER|||||||0.139|||||||Regression, Linear|||Effect of group on differences in ASR t scores from follicular to luteal.||||0.139
73799217|NCT02777372|147146264|OTHER|||||||0.843||||||Effect of group on ASR t score in the first luteal phase (no medication) to the second luteal phase (sertraline).|Regression, Linear|||||||0.843
73893007|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.14||||0.53||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.53
73893008|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.35||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.35
73893009|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.47||||0.09||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.09
73799218|NCT02777372|147146265|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
73799219|NCT04661150|147146267|SUPERIORITY||Treatment difference|23.8||||0.079|TWO_SIDED|90.0|1.3|44.7|||Chi-squared|||||44.7|1.3|0.079
73799220|NCT04661150|147146272|SUPERIORITY||Treatment difference|-4.8||||0.739|TWO_SIDED|90.0|-27.9|18.9|||Chi-squared|||||18.9|-27.9|0.739
73799221|NCT04661150|147146273|SUPERIORITY||Treatment difference|4.8|||>|0.999|TWO_SIDED|90.0|-10.9|21.4|||Fisher Exact|||||21.4|-10.9|>0.999
73799222|NCT05767905|147146275|OTHER||ratio|108.49|||||TWO_SIDED|90.0|100.55|117.05|||Mixed Models Analysis|"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment and Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment.||117.05|100.55|
73799223|NCT05767905|147146275|OTHER||ratio|106.16|||||TWO_SIDED|90.0|98.39|114.54|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.||114.54|98.39|
73799224|NCT05767905|147146275|OTHER||ratio|228.99|||||TWO_SIDED|90.0|178.67|293.48|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||293.48|178.67|
73799225|NCT05767905|147146275|OTHER||ratio|207.19|||||TWO_SIDED|90.0|164.41|261.09||||||Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||261.09|164.41|
73799226|NCT05767905|147146275|OTHER||ratio|102.19|||||TWO_SIDED|90.0|95.55|109.3|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment||109.30|95.55|
73799227|NCT05767905|147146276|OTHER||ratio|145.49|||||TWO_SIDED|90.0|121.29|174.53|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment.||174.53|121.29|
73799228|NCT05767905|147146276|OTHER||ratio|122.64|||||TWO_SIDED|90.0|102.24|147.12|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.||147.12|102.24|
73799229|NCT05767905|147146276|OTHER||ratio|284.72|||||TWO_SIDED|90.0|226.39|358.06|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||358.06|226.39|
73799230|NCT05767905|147146276|OTHER||ratio|327.87|||||TWO_SIDED|90.0|256.9|418.44|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||418.44|256.90|
73893010|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.51||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.04
73799231|NCT05767905|147146276|OTHER||ratio|118.63|||||TWO_SIDED|90.0|96.36|146.06|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment.||146.06|96.36|
73799232|NCT03762239|147146280|SUPERIORITY||Relative (percent) changes in the median|1.37||||0.52|TWO_SIDED|95.0|-2.81|5.56|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in better performance, relative to the classroom without air filter (normal air), in attention measures among adolescents in high schools.||5.56|-2.81|0.52
73799233|NCT03762239|147146281|SUPERIORITY||Beta coefficient|0.013||||0.72|TWO_SIDED|95.0|-0.0607|0.0865|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher riskloving behavior, relative to the classroom without air filter (normal air), in the combined risk taking measures among adolescents in high schools.||0.0865|-0.0607|0.72
73799234|NCT03762239|147146282|SUPERIORITY||Beta coefficient|-0.029||||0.5|TWO_SIDED|95.0|-0.117|0.0584|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher level of patience, relative to the classroom without air filter (normal air), in the combined patience measures among adolescents in high schools.||0.0584|-0.1170|0.50
73799235|NCT03762239|147146283|SUPERIORITY||Beta coefficient|0.06||||0.13|TWO_SIDED|95.0|-0.0184|0.1394|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher level of positive reciprocity behavior, relative to the classroom without air filter (normal air), in the positive reciprocity measures among adolescents in high schools||0.1394|-0.0184|0.13
73799236|NCT03762239|147146284|SUPERIORITY||Beta coefficient|0.022||||0.58|TWO_SIDED|95.0|-0.0595|0.1035|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher Altruism behavior, relative to the classroom without air filter (normal air), in the Altruism measures among adolescents in high schools.||0.1035|-0.0595|0.58
73799237|NCT03762239|147146285|SUPERIORITY||Beta coefficient|0.013||||0.89|TWO_SIDED|95.0|-0.1786|0.2049|||Ordered logistic regression|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher trust, relative to the classroom without air filter (normal air), in the subjective trust measure among adolescents in high schools.||0.2049|-0.1786|0.89
73799238|NCT03762239|147146286|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5|TWO_SIDED|95.0|-0.49|0.24|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|||0.24|-0.49|0.50
73799239|NCT03762239|147146287|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.47|TWO_SIDED|95.0|-0.2|0.1|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|||0.10|-0.20|0.47
73799240|NCT03762239|147146288|SUPERIORITY||Mean Difference (Final Values)|-3.38||||0.2|TWO_SIDED|95.0|-8.51|1.74|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||1.74|-8.51|0.20
73799241|NCT03762239|147146289|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.92|TWO_SIDED|95.0|-5.1|4.6|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||4.60|-5.10|0.92
73799242|NCT03762239|147146290|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.46|TWO_SIDED|95.0|-4.94|2.22|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||2.22|-4.94|0.46
73799243|NCT03762239|147146291|SUPERIORITY||Beta coefficient|-0.1446||||0.232|TWO_SIDED|95.0|-0.382|0.0928|||Ordered logistic regression|Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher assessment of math skills, relative to the classroom without air filter (normal air), in the self assessed math skills measure among adolescents in high schools.||0.0928|-0.3820|0.232
73799244|NCT04660331|147146311|OTHER||||||||||||||||||2-sided t-test conducted for pre- and post-training results.|||
73799245|NCT04660331|147146312|OTHER||||||||||||||||||We grouped pharmacy data on vaccines delivered pre/post intervention into six categories: HPV vaccine, Tdap, Meningococcal, Influenza, COVID-19, and other vaccines. We then compared the counts of total vaccines that were conducted in each group pre- and post-training.|||
73799246|NCT04660331|147146313|OTHER||||||||||||||||||We grouped pharmacy data on vaccines delivered pre/post intervention into six categories: HPV vaccine, Tdap, Meningococcal, Influenza, COVID-19, and other vaccines. We then compared the counts of total vaccines that were conducted in each group pre- and post-training.|||
73799247|NCT02635984|147146326|SUPERIORITY|||||||0.003|||||||Chi-squared|||Based on an 80 % power and an alpha of 0.05, we estimated a need for 49 patients in each treatment arm. From a review of existing literature, the sample size was based on an estimated CR achieved in 65 % of patients on triplet therapy alone and a hypothesized clinically relevant increase of 25 % for the treatment group to 90 %.||||0.003
73799248|NCT02635984|147146327|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
73799249|NCT02635984|147146328|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
73799250|NCT02635984|147146329|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
73799251|NCT02635984|147146330|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
73799252|NCT02635984|147146331|SUPERIORITY|||||||0.006|||||||Chi-squared|||||||0.006
73893011|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.35||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.10
73893012|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.35||||0.56||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.56
73893013|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.07||||0.84||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.84
73893014|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.59||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||
73893015|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.001||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||
73893016|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.22||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||
73893017|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||
73893018|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||
73893019|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.66||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||
73893020|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||
73893021|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||
73799253|NCT02635984|147146332|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
73799254|NCT02635984|147146333|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
73799255|NCT01776632|147146339|SUPERIORITY||difference of adjusted means|0.15||||0.03|TWO_SIDED||||||generalized linear mixed effects|||||||.03
73799256|NCT01776632|147146340|SUPERIORITY||difference of adjusted means|0.39||||0.003|TWO_SIDED||||||generalized linear mixed effects|||||||.003
73893022|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.29||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.08
73893023|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.05||||0.74||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.74
73893024|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.01||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.94
73893025|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.09||||0.51||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.51
73893026|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.27||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.12
73893027|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.25||||0.09||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.09
73893028|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.05||||0.81||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.81
73799257|NCT01776632|147146341|SUPERIORITY||difference of adjusted means|-0.43||||0.04|TWO_SIDED||||||mixed effects models|||||||.04
73893029|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.28||||0.07||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.07
73799258|NCT01776632|147146342|SUPERIORITY||difference of adjusted means|-1.27||||0.09|TWO_SIDED||||||mixed effects models|||||||.09
73799259|NCT00708110|147146360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.001|TWO_SIDED|95.0|-2.0|-1.07|||ANCOVA|||||-1.07|-2.00|<0.001
73799260|NCT00708110|147146360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|||<|0.001|TWO_SIDED|95.0|-2.52|-1.55|||ANCOVA|||||-1.55|-2.52|<0.001
73893030|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.36||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.02
73893031|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.08||||0.59||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.59
73893032|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.1||||0.51||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.51
73893033|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.02||||0.9||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.9
73893034|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.02
73893035|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.19||||0.2||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.20
73893036|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.18||||0.34||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.34
73893037|NCT00488683|147319165|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.33||||0.04||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.04
73893038|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
73893039|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.0027||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
73893040|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.0002||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
73893041|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.0077||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
73893042|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
73893043|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
73893044|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.0023||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
73893045|NCT00488683|147319165|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
73893046|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.25||||0.59||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.59
73893047|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.12||||0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.68
73893048|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.36||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.12
73893049|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.22||||0.26||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.26
73893050|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.43||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.08
73893051|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.17||||0.42||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.42
73799261|NCT00708110|147146360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|||<|0.001|TWO_SIDED|95.0|-2.94|-2.02|||ANCOVA|||||-2.02|-2.94|<0.001
73799262|NCT00951496|147146385|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study was designed to provide 80% power when arm II reduces the progression free survival event rate 20%. The critical p-value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.94||||0.341|TWO_SIDED|95.0|0.81|1.09||P value not adjusted for multiplicity. Significance Threshold = 0.027|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival of arm II relative to arm I. Adjusted for stage of disease and residual size.|P value.(an P value is used to determine statistical significance in a hypothesis test). from a stratified log rank test to assess equality of progression free survival hazards of arm II and arm I||1.09|0.81|0.341
73799263|NCT00951496|147146385|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study was designed to provide 80% power when arm III reduced the true progression free survival event rate. 20% compared to arm I. Critical p value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.99||||0.587|TWO_SIDED|95.0|0.86|1.15||P value not adjusted for multiplicity. Significance threshold = 0.027 accounting for 2 correlated primary hypotheses.|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival hazard of arm III to arm I. Adjusted for stage of disease and residual disease size.|P value from a log rank test comparing the progression free survival hazards of arm III to arm I.||1.15|0.86|0.587
73799264|NCT01526057|147146406|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC 0-inf) are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|105.67|||||TWO_SIDED|90.0|96.91|115.21|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way analysis of variance (ANOVA) model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.21|96.91|
73799265|NCT01526057|147146406|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|106.62|||||TWO_SIDED|90.0|97.65|116.41|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||116.41|97.65|
73799266|NCT01526057|147146406|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.9|||||TWO_SIDED|90.0|92.38|110.2|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||110.20|92.38|
73799267|NCT01526057|147146407|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|104.19|||||TWO_SIDED|90.0|92.75|117.06||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||117.06|92.75|
73799268|NCT01526057|147146407|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.45|||||TWO_SIDED|90.0|89.2|113.11||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.11|89.20|
73799269|NCT01526057|147146407|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|96.4|||||TWO_SIDED|90.0|85.57|108.6||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||108.60|85.57|
73799270|NCT01526057|147146408|SUPERIORITY||Test-to-reference ratio: adjusted means|103.74|||||TWO_SIDED|90.0|95.1|113.12|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.12|95.10|
73799271|NCT01526057|147146408|SUPERIORITY||Test-to-reference ratio: adjusted means|105.56|||||TWO_SIDED|90.0|96.64|115.3|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.30|96.64|
73799272|NCT01526057|147146408|SUPERIORITY||Test-to-reference ratio: adjusted means|101.76|||||TWO_SIDED|90.0|93.13|111.18|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data.||111.18|93.13|
73799273|NCT01526057|147146409|SUPERIORITY||Test-to-reference ratio: adjusted means|103.36|||||TWO_SIDED|90.0|92.81|115.12||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.12|92.81|
73799274|NCT01526057|147146409|SUPERIORITY||Test-to-reference ratio: adjusted means|101.33|||||TWO_SIDED|90.0|90.82|113.04||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.04|90.82|
73893052|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.02
73893053|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.12||||0.65||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.65
73893054|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.25||||0.58||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.58
73893055|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.19||||-0.51||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||-0.51
73893056|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.24
73893057|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.36||||0.06||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.06
73893058|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.72||||0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.001
73893059|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.32||||0.12||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.12
73893060|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.49||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.18
73893061|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.25||||0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.34
73893062|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||
73893063|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||
73893064|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||
73893065|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||
73893066|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
73893067|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
73799275|NCT01526057|147146409|SUPERIORITY||Test-to-reference ratio: adjusted means|98.03|||||TWO_SIDED|90.0|87.83|109.4||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||109.40|87.83|
73799276|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.31|1.78|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.||1.78|0.31|
73799277|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.6|1.88|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.||1.88|0.60|
73799278|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.66|1.73|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.||1.73|0.66|
73799279|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.73|1.56|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.||1.56|0.73|
73893068|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.6||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||
73893069|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||
73799280|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.68|1.62|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.||1.62|0.68|
73799281|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.66|1.69|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.||1.69|0.66|
73799282|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.7|2.0|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).||2.00|0.70|
73799283|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.28|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.||1.73|0.28|
73799284|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.43|1.54|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.||1.54|0.43|
73893070|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.83||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.001
73893071|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.14||||0.57||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.57
73893072|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.65||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.001
73893073|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.31||||0.11||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.11
73893074|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.02||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.94
73799285|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.49|1.42|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.||1.42|0.49|
73799286|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.5|1.22|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.||1.22|0.50|
73799287|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.57|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.||1.44|0.57|
73799288|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.88|2.1|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.||2.10|0.88|
73893075|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.0003||||1||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||1.00
73893076|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.004||||1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||1.00
73893077|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.3||||0.37||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.37
73799289|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.78|2.18|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).||2.18|0.78|
73893078|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.52||||0.09||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.09
73799290|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.36|2.45|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.||2.45|0.36|
73799291|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.41|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.||1.44|0.41|
73799292|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.47|1.31|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.||1.31|0.47|
73799293|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.48|1.13|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.||1.13|0.48|
73799294|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.55|1.36|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.||1.36|0.55|
73799295|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.85|1.95|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.||1.95|0.85|
73799296|NCT01526057|147146428|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.7|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).||1.73|0.70|
73799297|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.12|1.79|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.||1.79|0.12|
73799298|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.2|1.26|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.||1.26|0.20|
73799299|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.43|1.41|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.||1.41|0.43|
73799300|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.61|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.||1.74|0.61|
73799301|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.56|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.||1.74|0.56|
73799302|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.34|1.36|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.||1.36|0.34|
73799303|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.46|1.63|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).||1.63|0.46|
73799304|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.27|2.6|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.||2.60|0.27|
73799305|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.31|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.||1.62|0.31|
73799306|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.41|1.4|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.||1.40|0.41|
73799307|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.51|1.57|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.||1.57|0.51|
73799308|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.51|1.68|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.||1.68|0.51|
73799309|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.68|2.19|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.||2.19|0.68|
73799310|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.44|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).||1.62|0.44|
73799311|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|1.79|||||TWO_SIDED|95.0|0.44|7.2|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.||7.20|0.44|
73799312|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.52|3.86|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.||3.86|0.52|
73799313|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.51|1.87|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.||1.87|0.51|
73799314|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.5|1.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.||1.50|0.50|
73799315|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.52|1.69|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.||1.69|0.52|
73799316|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|1.8|||||TWO_SIDED|95.0|0.93|3.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.||3.50|0.93|
73799317|NCT01526057|147146429|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.51|1.89|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).||1.89|0.51|
73799318|NCT02289729|147146438|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
73799319|NCT02289729|147146439|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
73799320|NCT02289729|147146440|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
73799321|NCT02289729|147146441|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
73799322|NCT02289729|147146442|SUPERIORITY|||||||0.0328|||||||t-test|||||||0.0328
73799323|NCT02289729|147146443|SUPERIORITY|||||||0.4183|||||||t-test|||||||0.4183
73799324|NCT02289729|147146444|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
73799325|NCT02289729|147146445|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
73799326|NCT02289729|147146446|SUPERIORITY|||||||0.0109|||||||t-test|||||||0.0109
73799327|NCT02289729|147146447|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
73799328|NCT02289729|147146448|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
73799329|NCT02289729|147146449|SUPERIORITY|||||||0.0002|||||||signed-rank test|||||||0.0002
73799330|NCT02289729|147146450|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
73799331|NCT02289729|147146451|SUPERIORITY|||||||0.0038|||||||t-test|||||||0.0038
73799332|NCT02289729|147146452|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
73799333|NCT02289729|147146453|SUPERIORITY|||||||0.0274|||||||signed-rank test|||||||0.0274
73799334|NCT02289729|147146454|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
73799335|NCT02289729|147146455|SUPERIORITY|||||||0.0006|||||||t-test|||||||0.0006
73799336|NCT02289729|147146456|SUPERIORITY|||||||0.001|||||||signed-rank test|||||||0.0010
73799337|NCT02289729|147146457|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
73799338|NCT02289729|147146458|SUPERIORITY|||||||0.0297|||||||t-test|||||||0.0297
73799339|NCT02289729|147146459|SUPERIORITY|||||||0.0279|||||||t-test|||||||0.0279
73799340|NCT02289729|147146460|SUPERIORITY|||||||0.2777|||||||t-test|||||||0.2777
73799341|NCT02289729|147146461|SUPERIORITY|||||||0.0047|||||||t-test|||||||0.0047
73799342|NCT02289729|147146462|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
73799343|NCT02289729|147146463|SUPERIORITY||||||<|0.5877|||||||t-test|||||||<0.5877
73799344|NCT02289729|147146464|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
73799345|NCT02289729|147146465|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<0.0001
73799346|NCT02289729|147146466|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
73799347|NCT02289729|147146467|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
73799348|NCT02289729|147146468|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
73799349|NCT02289729|147146469|SUPERIORITY|||||||0.0001|||||||t-test|||||||0.0001
73799350|NCT02289729|147146470|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
73893079|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.21||||0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.40
73893080|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.2||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.20
73893081|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.03
73893082|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.48||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.07
73799351|NCT02289729|147146471|SUPERIORITY|||||||0.2428|||||||signed-rank test|||||||0.2428
73799352|NCT02289729|147146472|SUPERIORITY|||||||0.0687|||||||t-test|||||||0.0687
73799353|NCT02289729|147146473|SUPERIORITY|||||||0.3126|||||||t-test|||||||0.3126
73799354|NCT02289729|147146474|SUPERIORITY|||||||0.1533|||||||t-test|||||||0.1533
73799355|NCT02289729|147146475|SUPERIORITY|||||||0.8145|||||||t-test|||||||0.8145
73799356|NCT02289729|147146476|SUPERIORITY|||||||0.4048|||||||t-test|||||||0.4048
73893083|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.22||||0.3||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.30
73893084|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.26||||0.74||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.74
73799357|NCT02289729|147146477|SUPERIORITY|||||||0.8321|||||||t-test|||||||0.8321
73799358|NCT02289729|147146478|SUPERIORITY|||||||0.1945|||||||signed-rank test|||||||0.1945
73893085|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.378||||0.25||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.25
73799359|NCT02289729|147146479|SUPERIORITY|||||||0.7937|||||||t-test|||||||0.7937
73799360|NCT02289729|147146480|SUPERIORITY|||||||0.0234|||||||signed-rank test|||||||0.0234
73799361|NCT02289729|147146481|SUPERIORITY|||||||0.5922|||||||t-test|||||||0.5922
73799362|NCT02289729|147146482|SUPERIORITY|||||||1|||||||t-test|||||||1.000
73799363|NCT02289729|147146483|SUPERIORITY|||||||0.6481|||||||t-test|||||||0.6481
73799364|NCT02289729|147146484|SUPERIORITY|||||||0.6741|||||||t-test|||||||0.6741
73799365|NCT02289729|147146485|OTHER||Fisher's z|0.27846||||0.0389|TWO_SIDED|95.0|0.014175|0.495059|||Fisher's z Transformation|||PDQ-39 with UPDRS-III||0.495059|0.014175|0.0389
73799366|NCT02289729|147146485|OTHER||Fisher's z|0.07359||||0.5852|TWO_SIDED|95.0|-0.188409|0.32558|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV||0.325580|-0.188409|0.5852
73799367|NCT02289729|147146485|OTHER||Fisher's z|0.21311||||0.114|TWO_SIDED|95.0|-0.051127|0.444152|||Fisher's z Transformation|||PDQ-39 with NMSS||0.444152|-0.051127|0.1140
73799368|NCT02289729|147146485|OTHER||Fisher's z|0.29062||||0.0311|TWO_SIDED|95.0|0.026334|0.504186|||Fisher's z Transformation|||PDQ-39 with BAI||0.504186|0.026334|0.0311
73799369|NCT02289729|147146485|OTHER||Fisher's z|0.49952||||0.0002|TWO_SIDED|95.0|0.230995|0.643312|||Fisher's z Transformation|||PDQ-39 with BDI-II||0.643312|0.230995|0.0002
73799370|NCT02289729|147146485|OTHER||Fisher's z|0.08869||||0.5146|TWO_SIDED|95.0|-0.176169|0.341163|||Fisher's z Transformation|||PDQ-39 with AS||0.341163|-0.176169|0.5146
73799371|NCT02289729|147146485|OTHER||Fisher's z|0.34688||||0.0108|TWO_SIDED|95.0|0.079996|0.546657|||Fisher's z Transformation|||PDQ-39 with PFS||0.546657|0.079996|0.0108
73799372|NCT02289729|147146485|OTHER||Fisher's z|0.22455||||0.0989|TWO_SIDED|95.0|-0.042139|0.455224|||Fisher's z Transformation|||PDQ-39 with NBL A-S||0.455224|-0.042139|0.0989
73799373|NCT02289729|147146485|OTHER||Fisher's z|0.35742||||0.006|TWO_SIDED|95.0|0.106797|0.565335|||Fisher's z Transformation|||PDQ-39 with NBL C-D||0.565335|0.106797|0.0060
73799374|NCT02289729|147146485|OTHER||Fisher's z|0.00011||||0.9993|TWO_SIDED|95.0|-0.260462|0.260673|||Fisher's z Transformation|||PDQ-39 with NBL C-R||0.260673|-0.260462|0.9993
73799375|NCT02289729|147146485|OTHER||Fisher's z|-0.36687||||0.0088|TWO_SIDED|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||PDQ-39 with ZBI||-0.092154|-0.565795|0.0088
73799376|NCT02289729|147146485|OTHER||Fisher's z|0.21643||||0.1222|TWO_SIDED|95.0|-0.057959|0.454911|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety||0.454911|-0.057959|0.1222
73799377|NCT02289729|147146485|OTHER||Fisher's z|0.57423||||0.0041|TWO_SIDED|95.0|0.180247|0.74704|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression||0.747040|0.180247|0.0041
73799378|NCT02289729|147146486|OTHER||Fisher's z|0.31946||||0.0239|TWO_SIDED|95.0|0.042257|0.534657|||Fisher's z Transformation|||PDQ-39 with UPDRS-III||0.534657|0.042257|0.0239
73799379|NCT02289729|147146486|OTHER||Fisher's z|0.36796||||0.0093|TWO_SIDED|95.0|0.090528|0.568388|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV||0.568388|0.090528|0.0093
73799380|NCT02289729|147146486|OTHER||Fisher's z|0.38627||||0.0069|TWO_SIDED|95.0|0.105875|0.582517|||Fisher's z Transformation|||PDQ-39 with NMSS||0.582517|0.105875|0.0069
73799381|NCT02289729|147146486|OTHER||Fisher's z|0.70289|||<|0.0001|TWO_SIDED|95.0|0.40173|0.753097|||Fisher's z Transformation|||PDQ-39 with BAI||0.753097|0.401730|< 0.0001
73799382|NCT02289729|147146486|OTHER||Fisher's z|0.63758|||<|0.0001|TWO_SIDED|95.0|0.345567|0.72341|||Fisher's z Transformation|||PDQ-39 with BDI-II||0.723410|0.345567|<0.0001
73799383|NCT02289729|147146486|OTHER||Fisher's z|0.24114||||0.0882|TWO_SIDED|95.0|-0.036024|0.476404|||Fisher's z Transformation|||PDQ-39 with AS||0.476404|-0.036024|0.0882
73893086|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.69||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||
73893087|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||
73893088|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.42||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||
73893089|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||
73893090|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.0004||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
73893091|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
73893092|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||
73893093|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.9||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||
73893094|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.86||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.86
73799384|NCT02289729|147146486|OTHER||Fisher's z|0.67113|||<|0.0001|TWO_SIDED|95.0|0.374757|0.739016|||Fisher's z Transformation|||PDQ-39 with PFS||0.739016|0.374757|< 0.0001
73893095|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.08||||0.7||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.7
73893096|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.11||||0.58||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.58
73893097|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.13||||0.44||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.44
73893098|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.07||||0.75||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.75
73893099|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.84||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.84
73799385|NCT02289729|147146486|OTHER||Fisher's z|0.60612|||<|0.0001|TWO_SIDED|95.0|0.317572|0.708072|||Fisher's z Transformation|||PDQ-39 with NBL A-S||0.708072|0.317572|< 0.0001
73893100|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.11||||0.67||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.67
73893101|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.002||||0.99||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.99
73893102|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.62
73799386|NCT02289729|147146486|OTHER||Fisher's z|0.60613|||<|0.0001|TWO_SIDED|95.0|0.31758|0.708076|||Fisher's z Transformation|||PDQ-39 with NBL C-D||0.708076|0.317580|< 0.0001
73799387|NCT02289729|147146486|OTHER||Fisher's z|0.41143||||0.0036|TWO_SIDED|95.0|0.133445|0.597087|||Fisher's z Transformation|||PDQ-39 with NBL C-R||0.597087|0.133445|0.0036
73799388|NCT02289729|147146486|OTHER||Fisher's z|-0.33661||||0.0239|TWO_SIDED|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||PDQ-39 with ZBI||-0.044411|-0.557217|0.0239
73799389|NCT02289729|147146486|OTHER||Fisher's z|0.64565|||<|0.0001|TWO_SIDED|95.0|0.339454|0.734221|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety||0.734221|0.339454|< 0.0001
73799390|NCT02289729|147146486|OTHER||Fisher's z|0.10898||||0.7058|TWO_SIDED|95.0|-0.427482|0.588111|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression||0.588111|-0.427482|0.7058
73893103|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.17||||0.36||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.36
73893104|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.003||||0.99||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.99
73893105|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.2||||0.24||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.24
73893106|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.62
73893107|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.08||||0.69||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.69
73893108|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.13||||0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.60
73893109|NCT00488683|147319166|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.01||||0.95||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.95
73893110|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.0015||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
73893111|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.0057||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
73893112|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
73799391|NCT02289729|147146487|OTHER||Fisher's z|-0.57271|||<|0.0001|TWO_SIDED|95.0|-0.689585|-0.289724|||Fisher's z Transformation|||SQLC with ZBI||-0.289724|-0.689585|< 0.0001
73799392|NCT02289729|147146487|OTHER||Fisher's z|-0.16332||||0.4142|TWO_SIDED|95.0|-0.504489|0.224771|||Fisher's z Transformation|||SQLC with Goldberg Anxiety||0.224771|-0.504489|0.4142
73893113|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
73893114|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.0048||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
73893115|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.0018||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
73893116|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
73799393|NCT02289729|147146487|OTHER||Fisher's z|-0.48143||||0.0239|TWO_SIDED|95.0|-0.715956|-0.063481|||Fisher's z Transformation|||SQLC with Goldberg Depression||-0.063481|-0.715956|0.0239
73893117|NCT00488683|147319166|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
73893118|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.14||||0.68||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||0.68
73893119|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.44||||0.09||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||0.09
73799394|NCT02289729|147146487|OTHER||Fisher's z|0.06326||||0.6546|TWO_SIDED|95.0|-0.210715|0.327872|||Fisher's z Transformation|||SQLC with NBL A-S||0.327872|-0.210715|0.6546
73799395|NCT02289729|147146487|OTHER||Fisher's z|0.17674||||0.2114|TWO_SIDED|95.0|-0.100105|0.425116|||Fisher's z Transformation|||SQLC with NBL C-D||0.425116|-0.100105|0.2114
73799396|NCT02289729|147146487|OTHER||Fisher's z|0.2944||||0.0374|TWO_SIDED|95.0|0.017222|0.516523|||Fisher's z Transformation|||SQLC with NBL C-R||0.516523|0.017222|0.0374
73893120|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.11||||0.69||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||0.69
73893121|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.38||||0.2||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||0.20
73893122|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.88||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||0.88
73893123|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.12||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||0.12
73893124|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.25||||0.37||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||0.37
73893125|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||0.36
73893126|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||
73893127|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.2||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||
73893128|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||
73893129|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.15||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||
73893130|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|1.0||||||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
73893131|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|1.0||||||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
73893132|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
73893133|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup W-135||||
73893134|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup Y||||
73799397|NCT02289729|147146487|OTHER||Fisher's z|-0.36687||||0.0088|TWO_SIDED|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||SQLC with Global PDQ-39||-0.092154|-0.565795|0.0088
73799398|NCT02289729|147146487|OTHER||Fisher's z|-0.13433||||0.3374|TWO_SIDED|95.0|-0.387439|0.139207|||Fisher's z Transformation|||SQLC with UPDRS-III||0.139207|-0.387439|0.3374
73893135|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.08||||0.79||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||0.79
73893136|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.35||||0.16||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||0.16
73799399|NCT02289729|147146487|OTHER||Fisher's z|0.17846||||0.2025|TWO_SIDED|95.0|-0.095693|0.424291|||Fisher's z Transformation|||SQLC with UPDRS-IV||0.424291|-0.095693|0.2025
73799400|NCT02289729|147146487|OTHER||Fisher's z|0.01625||||0.9076|TWO_SIDED|95.0|-0.252613|0.282777|||Fisher's z Transformation|||SQLC with Global NMSS||0.282777|-0.252613|0.9076
73799401|NCT02289729|147146488|OTHER||Fisher's z|-0.7468|||<|0.0001|TWO_SIDED|95.0|-0.777482|-0.425693|||Fisher's z Transformation|||SQLC with ZBI||-0.425693|-0.777482|< 0.0001
73893137|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.48||||0.1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||0.10
73893138|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.98||||0.003||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||0.003
73799402|NCT02289729|147146488|OTHER||Fisher's z|0.17924||||0.5347|TWO_SIDED|95.0|-0.368382|0.632178|||Fisher's z Transformation|||SQLC with Goldberg Anxiety||0.632178|-0.368382|0.5347
73799403|NCT02289729|147146488|OTHER||Fisher's z|-0.06987||||0.8251|TWO_SIDED|95.0|-0.597767|0.500464|||Fisher's z Transformation|||SQLC with Goldberg Depression||0.500464|-0.597767|0.8251
73799404|NCT02289729|147146488|OTHER||Fisher's z|-0.1106||||0.4581|TWO_SIDED|95.0|-0.382323|0.179601|||Fisher's z transformation|||SQLC with NBL A-S||0.179601|-0.382323|0.4581
73799405|NCT02289729|147146488|OTHER||Fisher's z|0.00326||||0.9826|TWO_SIDED|95.0|-0.281136|0.287128|||Fisher's z Transformation|||SQLC with NBL C-D||0.287128|-0.281136|0.9826
73893139|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.03||||0.91||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||0.91
73893140|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.57||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||0.01
73893141|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.19||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||0.19
73799406|NCT02289729|147146488|OTHER||Fisher's z|-0.10293||||0.4899|TWO_SIDED|95.0|-0.375749|0.187021|||Fisher's z Transformation|||SQLC with NBL C-R||0.187021|-0.375749|0.4899
73799407|NCT02289729|147146488|OTHER||Fisher's z|-0.33661||||0.0239|TWO_SIDED|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||SQLC with Global PDQ-39||-0.044411|-0.557217|0.0239
73799408|NCT02289729|147146488|OTHER||Fisher's z|-0.23658||||0.1125|TWO_SIDED|95.0|-0.484427|0.055538|||Fisher's z Transformation|||SQLC with UPDRS-III||0.055538|-0.484427|0.1125
73799409|NCT02289729|147146488|OTHER||Fisher's z|-0.13015||||0.3826|TWO_SIDED|95.0|-0.398887|0.16062|||Fisher's z Transformation|||SQLC with UPDRS-IV||0.160620|-0.398887|0.3826
73799410|NCT02289729|147146488|OTHER||Fisher's z|0.11688||||0.4382|TWO_SIDED|95.0|-0.176724|0.390468|||Fisher's z Transformation|||SQLC with Global NMSS||0.390468|-0.176724|0.4382
73799411|NCT01875978|147146489|SUPERIORITY_OR_OTHER||||||<|0.05||||||P-value \<0.05 is significance meaningful.|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis: phytosterols improve metabolic status||||<0.05
73799412|NCT01875978|147146490|SUPERIORITY_OR_OTHER||||||<|0.05||||||P value \<0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Hypothesis: phytosterols increase the anti-oxidative capacity.||||<0.05
73799413|NCT01875978|147146491|SUPERIORITY_OR_OTHER||||||<|0.05||||||P\<0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Phytosterols increase IGF-1||||<0.05
73799414|NCT01875978|147146492|SUPERIORITY_OR_OTHER||||||<|0.05||||||P value \<0.05 for statistical significance|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis:phytosterols increase endothelial progenitor cells to provide endothelial repair and vessel protection||||<0.05
73799415|NCT04870710|147146496|SUPERIORITY||Median Difference (Net)|0.1||||0.1|TWO_SIDED||||||Friedman||||Non-parametric tests were used consisting of Friedman and Durbin Conover tests|||0.10
73799416|NCT03123068|147146514|OTHER||||||>|0.05|||||||Mann Whitney U test|||||||>0.05
73799417|NCT02329015|147146518|SUPERIORITY_OR_OTHER||Slope|0.58||||0.54|TWO_SIDED|95.0|-1.25|2.41|||Regression, Logistic|||Model 1: An intent to treat analyses was performed determining effect of group assignment on academic performance while controlling for previous year GPA.||2.41|-1.25|0.54
73799418|NCT02329015|147146518|SUPERIORITY_OR_OTHER||Slope|1.67||||0.08|TWO_SIDED|95.0|-0.21|3.55|||Regression, Linear|||Model 2: As active participation between groups was significantly different a second intent to treat analysis was performed which added to Model 1 (controlling for previous year GPA) by controlling for active participation.||3.55|-0.21|0.08
73799419|NCT02329015|147146518|SUPERIORITY_OR_OTHER||Slope|2.7||||0.009|TWO_SIDED|95.0|0.69|4.71|||Regression, Linear|||Model 3: Per Protocol Analysis: it was hypothesized that any benefit of yoga education would only accrue if the student was assigned to yoga classes and actively participated in the class. A third Model was fit with an interaction term for class assignment and class participation.||4.71|0.69|0.009
73799420|NCT02329015|147146519|SUPERIORITY_OR_OTHER|||||||0.301|||||||Regression, Linear|||Analysis of the Voluntary subscale of the Response to Stress Questionnaire||||0.301
73799421|NCT01263938|147146592|OTHER|||||||0.625||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.625
73799422|NCT01263938|147146592|OTHER|||||||0.813||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.813
73799423|NCT01263938|147146592|OTHER||||||>|0.999||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||>0.999
73799424|NCT01263938|147146593|OTHER||||||>|0.999||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||>0.999
73799425|NCT01263938|147146594|OTHER|||||||0.813||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.813
73893142|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.89||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||0.04
73799426|NCT01263938|147146595|OTHER|||||||0.625||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.625
73799427|NCT05620082|147146620|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73799428|NCT05620082|147146621|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73799429|NCT05620082|147146622|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73799430|NCT05620082|147146623|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Comparing Appearance of supplements||||0.10
73799431|NCT05620082|147146623|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Comparing Smell of supplements between groups||||0.10
73799432|NCT05620082|147146623|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Comparing Taste of supplements||||0.08
73799433|NCT05620082|147146623|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Comparing Sweetness of supplements||||0.70
73799434|NCT05620082|147146623|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Comparing Texture of supplements||||0.02
73799435|NCT05620082|147146623|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparing Thickness of supplements||||0.45
73799436|NCT05620082|147146623|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Comparing Aftertaste of supplements||||0.25
73799437|NCT05620082|147146623|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparing 'Feeling in mouth' of supplements||||0.45
73799438|NCT05620082|147146623|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparing 'Future choice' of supplements||||0.06
73799439|NCT05620082|147146624|SUPERIORITY|||||||0.004||||||Pairwise comparisons with Bonferroni correction revealed a significant increase in total daily energy intake from baseline to porridge timepoints (p\<0.001).|Related samples Friedman's Two-Way ANOVA|||||||0.004
73799440|NCT02360215|147146625|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.029|TWO_SIDED|95.0|0.59|0.96|||Gray's test|||Null hypothesis: the addition of HA-WBRT as compared to WBRT will increase time to neurocognitive failure from 53.8% in the WBRT arm to 42.8% in the HA-WBRT arm at 6 months. Treating death as a competing risk and using a Gray's test with two-sided α=0.05 to test for statistically significant difference in the distribution of neurocognitive failure times, it was calculated that 230 events over both arms would provide 90% statistical power.||0.96|0.59|0.029
73799441|NCT02360215|147146626|SUPERIORITY|||||||0.0586|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.0586
73799442|NCT02360215|147146626|SUPERIORITY|||||||0.0048|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\>61 year vs. \<= 61 years) is reported here.||||0.0048
73799443|NCT02360215|147146626|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Total Recall is reported here.||||<0.0001
73799444|NCT02360215|147146627|SUPERIORITY|||||||0.2656|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.2656
73799445|NCT02360215|147146627|SUPERIORITY|||||||0.0067|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0067
73799446|NCT02360215|147146627|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recall is reported here.||||<0.0001
73799447|NCT02360215|147146628|SUPERIORITY|||||||0.0993|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.0993
73799448|NCT02360215|147146628|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0001
73799449|NCT02360215|147146628|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recognition is reported here.||||<0.0001
73799450|NCT02360215|147146629|SUPERIORITY|||||||0.5988|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.5988
73799451|NCT02360215|147146629|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0005
73799452|NCT02360215|147146629|SUPERIORITY||||||<|0.0001|||||||McNemar|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part A is reported here.||||<0.0001
73799453|NCT02360215|147146630|SUPERIORITY|||||||0.9226|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9226
73799454|NCT02360215|147146630|SUPERIORITY||||||<|0.0024|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0024
73799455|NCT02360215|147146630|SUPERIORITY||||||<|0.0001|||||||Regression, Cox|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part B is reported here.||||<0.0001
73799456|NCT02360215|147146631|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline COWA is reported here.||||<0.0001
73799457|NCT02360215|147146631|SUPERIORITY|||||||0.9749|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9749
73799458|NCT02360215|147146631|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here. is reported here.||||<0.0001
73799459|NCT02360215|147146632|SUPERIORITY|||||||0.2552|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.2552
73799460|NCT02360215|147146632|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0001
73799461|NCT02360215|147146632|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline composite score is reported here.||||<0.0001
73799462|NCT02360215|147146633|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.57
73799463|NCT02360215|147146633|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Severity score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline symptom severity is reported here.||||<0.0001
73799464|NCT02360215|147146633|SUPERIORITY|||||||0.083|||||||Mixed Models Analysis|||A two-sample t-test with a 2-sided type I error of 0.05 provides \>90% statistical power to detect a medium effect size of 0.5 for a comparison of the change from baseline to 6 months from the start of treatment. The comparison at six months was tested within a mixed effects model with covariates age, RPA class, prior radiosurgery, prior surgical resection, baseline score, treatment arm, and time was used.||||0.083
73799465|NCT02360215|147146634|SUPERIORITY|||||||0.9118|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9118
73799466|NCT02360215|147146634|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline interference score is reported here.||||<0.0001
73799467|NCT02360215|147146635|SUPERIORITY|||||||0.1964|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.1964
73799468|NCT02360215|147146635|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline cognitive factor score is reported here.||||<0.0001
73799469|NCT02360215|147146635|SUPERIORITY|||||||0.0032|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Prior radiotherapy (yes vs. no) is reported here.||||0.0032
73799470|NCT02360215|147146636|SUPERIORITY|||||||0.8877|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.8877
73799471|NCT02360215|147146636|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline neurologic factor is reported here.||||<0.0001
73893143|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||
73893144|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.12||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||
73893145|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.23||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||
73893146|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.96||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||
73893147|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.18||||0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||0.46
73893148|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.9||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||0.90
73893149|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.51||||0.008||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||0.008
73893150|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.42||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||0.08
73893151|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.15||||0.52||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||0.52
73893152|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.27||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||0.18
73893153|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.37||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||0.07
73893154|NCT00488683|147319167|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.14||||0.55||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||0.55
73893155|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||
73893156|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.0007||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||
73893157|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.27||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||
73893158|NCT00488683|147319167|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||
73893159|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.45||||0.0006||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||0.0006
73893160|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.0021||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||0.0021
73893161|NCT00488683|147319168|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||
73893162|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.15||||0.53||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells 1 month after booster vaccination||||0.53
73893163|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.21||||0.26||95.0|||||Parametric correlation||Values from Groups 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.26
73893164|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.84||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.84
73893165|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Spearman Correlation Coefficient|0.22||||0.26||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.26
73893166|NCT00488683|147319168|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||
73893167|NCT00488683|147319168|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||
73893168|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.33|||<|0.001||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
73893169|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.46|||<|0.001||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
73893170|NCT00488683|147319168|SUPERIORITY_OR_OTHER||R-square|0.11|||<|0.001||95.0|||||Regression, Linear||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
73799472|NCT02360215|147146636|SUPERIORITY|||||||0.0078|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0078
73799473|NCT02360215|147146637|SUPERIORITY|||||||0.86||||||Significance level = 0.05|t-test, 2 sided|||||||0.86
73799474|NCT02360215|147146639|SUPERIORITY|||||||0.95||||||Significance level = 0.05|t-test, 2 sided|||||||0.95
73799475|NCT02360215|147146640|SUPERIORITY|||||||0.66||||||Significance level = 0.05|t-test, 2 sided|||||||0.66
73799476|NCT02360215|147146641|SUPERIORITY|||||||0.18||||||Significance level = 0.05|t-test, 2 sided|||||||0.18
73893171|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.24||||0.06||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.06
73893172|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.5|||<|0.001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||<0.001
73893173|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.31||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.01
73893174|NCT00488683|147319168|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.10
73799477|NCT02360215|147146642|SUPERIORITY|||||||0.64||||||Significance level = 0.05|t-test, 2 sided|||||||0.64
73799478|NCT02360215|147146643|SUPERIORITY|||||||0.91||||||Significance level = 0.05|t-test, 2 sided|||||||0.91
73799479|NCT02360215|147146644|OTHER|||||||0.92||||||Significance level = 0.05|t-test, 2 sided|||||||0.92
73799480|NCT02360215|147146645|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.076|TWO_SIDED|95.0|0.98|1.47||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantine|||1.47|0.98|0.076
73799481|NCT02360215|147146646|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.242|TWO_SIDED|95.0|0.91|1.43||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantin|||1.43|0.91|0.242
73799482|NCT02360215|147146647|SUPERIORITY|||||||0.47||||||Two-sided p-value = 0.05|Chi-squared|||||||0.47
73799483|NCT01996241|147146668|OTHER|Odds ratio (95% CI), p-value for all the outcomes.|Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.7|1.38||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.38|0.7|0.98
73799484|NCT01996241|147146669|OTHER||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.7|1.4||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.4|0.7|0.98
73799485|NCT01996241|147146670|OTHER||Odds Ratio (OR)|1.32||||0.331|TWO_SIDED|95.0|0.2|2.31||Adjusted for village strata and cluster, village type, caste, household literacy status, stratum using individual-level data and poor learning environment at school, school dropout, and marriage (in the form of cluster-level summaries).|Regression, Logistic|Mixed-effects||||2.31|0.2|0.331
73799486|NCT01996241|147146671|OTHER||Odds Ratio (OR)|0.83||||0.26|TWO_SIDED|95.0|0.6|1.15||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.15|0.6|0.26
73799487|NCT01996241|147146672|OTHER||Odds Ratio (OR)|1.05||||0.79|TWO_SIDED|95.0|0.7|1.55||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.55|0.7|0.79
73799488|NCT01996241|147146673|OTHER||Odds Ratio (OR)|0.83||||0.45|TWO_SIDED|95.0|0.5|1.34||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.34|0.5|0.45
73799489|NCT03052751|147146695|SUPERIORITY||LS Mean Difference vs Placebo|-0.7|||=|0.221|ONE_SIDED|95.0||0.8||One-sided p-value was presented for difference.|MMRM||Estimate included treatment and treatment by visit interaction effects.|"Mixed Model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline QMG score, and random effect for participant.~The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'."||0.8||=0.221
73799490|NCT03052751|147146696|SUPERIORITY||LS Mean Difference vs Placebo|-1.8|||=|0.089|ONE_SIDED|95.0||0.4||One-sided p-value was presented for difference.|MMRM||Estimate included treatment and treatment by visit interaction effects.|"MMRM ANCOVA model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline MG-composite score, and random effect for participant.~The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'."||0.4||=0.089
73799491|NCT03052751|147146697|SUPERIORITY||LS Mean Difference vs Placebo|-1.4|||=|0.036|ONE_SIDED|95.0||-0.1||One-sided p-value was presented for difference.|ANCOVA||Estimate included treatment effect.|ANCOVA model included fixed terms for treatment group, covariate of Baseline MGADL score.||-0.1||=0.036
73799492|NCT02719184|147146698|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-2.89|STANDARD_ERROR_OF_MEAN|1.23||0.0202|TWO_SIDED|95.0|-5.32|-0.45|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD I group - value from Healthy subjects group.|||-0.45|-5.32|0.0202
73799493|NCT02719184|147146698|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-4.78|STANDARD_ERROR_OF_MEAN|1.31||0.0003|TWO_SIDED|95.0|-7.36|-2.19|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD II group - value from Healthy subjects group.|||-2.19|-7.36|0.0003
73799494|NCT02719184|147146698|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-4.47|STANDARD_ERROR_OF_MEAN|1.51||0.0033|TWO_SIDED|95.0|-7.44|-1.5|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD III group - value from Healthy subjects group.|||-1.50|-7.44|0.0033
73799495|NCT02719184|147146698|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-5.86|STANDARD_ERROR_OF_MEAN|2.74||0.0334|TWO_SIDED|95.0|-11.26|-0.47|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD and A1AT group - value from Healthy subjects group.|||-0.47|-11.26|0.0334
73799496|NCT02719184|147146699|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|14.4||0.9306|TWO_SIDED|95.0|-27.2|29.7|||Random slope and intercept model||The mean difference was calculated as value from COPD GOLD I group - value from Healthy subjects group.|||29.7|-27.2|0.9306
73799497|NCT02719184|147146699|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-19.2|STANDARD_ERROR_OF_MEAN|14.9||0.1983|TWO_SIDED|95.0|-48.5|10.1|||Random slope and intercept model|The mean difference was calculated as value from COPD GOLD II group - value from Healthy subjects group.||||10.1|-48.5|0.1983
73893175|NCT00488683|147319168|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear|||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||
73893176|NCT00488683|147319168|SUPERIORITY_OR_OTHER||R-square|0.25||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||
73799498|NCT02719184|147146699|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-33.6|STANDARD_ERROR_OF_MEAN|16.1||0.0381|TWO_SIDED|95.0|-65.4|-1.9|||Random slope and intercept model||The mean difference was calculated as value from COPD GOLD III group - value from Healthy subjects group.|||-1.9|-65.4|0.0381
73799499|NCT02719184|147146699|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-61.8|STANDARD_ERROR_OF_MEAN|30.3||0.0419|TWO_SIDED|95.0|-121.3|-2.3|||Random slope and intercept model||The mean difference was calculated as value from COPD and A1AT group - value from Healthy subjects group.|||-2.3|-121.3|0.0419
73799500|NCT02091856|147146710|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in primary outcome measures were evaluated using repeated measures ANOVA for three groups: C-CBT, R-CBT, WLCG and two time points: pre \& post||It was hypothesized that regardless of the CBT version received (conventional or religious), those in the active treatments would achieve a greater reduction in depressive and associated symptoms than participants in the wait-list condition.||||<0.001
73799501|NCT02091856|147146711|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in secondary outcome measures were evaluated using repeated measures ANOVA (C-CBT, R-CBT, WLCG at pre- and post-intervention).||||||>0.05
73799502|NCT02091856|147146712|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|||||||<0.01
73893177|NCT00488683|147319174|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.04||||0.7||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||0.70
73893178|NCT00488683|147319174|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.63||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||0.63
73893179|NCT00488683|147319174|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||0.74
73893180|NCT00488683|147319174|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||0.74
73893181|NCT00488683|147319174|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.18||||0.05||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||0.05
73893182|NCT00488683|147319174|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.07||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||0.36
73893183|NCT00488683|147319174|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.11||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||0.18
73893184|NCT00488683|147319174|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.02||||0.82||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||0.82
73893185|NCT00488683|147319174|SUPERIORITY_OR_OTHER||R-square|0.0013||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||
73893186|NCT00488683|147319174|SUPERIORITY_OR_OTHER||R-square|0.0014||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||
73893187|NCT00488683|147319174|SUPERIORITY_OR_OTHER||R-square|0.0008||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||
73893188|NCT00488683|147319174|SUPERIORITY_OR_OTHER||R-square|0.0009||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||
73893189|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.34||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
73893190|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.14||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
73893191|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.09||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells at 5 months of age and hSBA titers at 12 months of age after a 2, 4-month course of MenACWY-CRM vaccination for the serogroup C||||
73893192|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.16||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
73893193|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.22||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
73893194|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.33||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
73893195|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.74||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
73893196|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.53||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
73893197|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.37||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
73893198|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.14||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
73893199|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
73893200|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
73799503|NCT02091856|147146713|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|||||||<0.001
73799504|NCT02091856|147146714|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|t-test, 1 sided|||||||<0.01
73799505|NCT01050530|147146715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|||<|0.0001|TWO_SIDED|95.0|-2.08|-0.93|||t-test, 2 sided|||||-0.93|-2.08|<0.0001
73799506|NCT01050530|147146716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-300.7||||0.0093|TWO_SIDED|95.0|-526.2|-75.1|||t-test, 2 sided|||||-75.1|-526.2|0.0093
73799507|NCT01332487|147146779|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Acute Urinary Retention|Chi-squared|||||||0.002
73799508|NCT01332487|147146779|SUPERIORITY_OR_OTHER|||||||0||95.0||||Surgery|Chi-squared|||||||0.000
73799509|NCT01332487|147146779|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Emergency Surgery|Chi-squared|||||||0.597
73799510|NCT02440464|147146801|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.10.|Log Rank|||The null hypothesis is that there is no difference in progression-free survival time post-randomization among randomized subjects receiving Ixazomib vs Placebo maintenance therapy during the 21 month period post-randomization. This was compared between treatment arms using a log rank test.||||1.0
73799511|NCT02440464|147146802|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with acute grade III-IV GVHD between the Ixazomib and Placebo arms during 100 days post-randomization, with death prior to acute GVHD treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
73799512|NCT02440464|147146803|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with chronic GVHD between the Ixazomib and Placebo arms during 21 months post-randomization, with death prior to chronic GVHD treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
73799513|NCT02440464|147146804|SUPERIORITY|The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.||||||0.89|||||||Fisher Exact|Statistical significance was determined using a pre-specified one-sided threshold of 0.05.||Participants in sCR/CR at Randomization||||0.890
73799514|NCT02440464|147146804|SUPERIORITY|||||||0.754||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants not in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.||||0.754
73799515|NCT02440464|147146806|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with progression between the Ixazomib and Placebo arms during 21 months post-randomization, with death prior to progression treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
73799516|NCT02440464|147146807|SUPERIORITY|||||||0.174||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference in overall survival time post-randomization among randomized subjects receiving Ixazomib vs Placebo maintenance therapy during the 21 month period post-randomization. This was compared between treatment arms using a log rank test.||||0.174
73799517|NCT02440464|147146808|SUPERIORITY|||||||0.173||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with treatment-related mortality between the Ixazomib and Placebo arms during 21 months post-randomization, with progression treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||0.173
73799518|NCT02440464|147146810|SUPERIORITY|||||||0.258||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 6 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.258
73799519|NCT02440464|147146810|SUPERIORITY|||||||0.252||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 12 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.252
73799520|NCT02440464|147146810|SUPERIORITY|||||||0.258||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 18 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.258
73799521|NCT02440464|147146812|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 6 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
73893201|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.9||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
73893202|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.78||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
73893203|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.94||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
73893204|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.85||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
73893205|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
73893206|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
73893207|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.007||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
73893208|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.04||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
73893209|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
73893210|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
73893211|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
73893212|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.28||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
73893213|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.3||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
73893214|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
73893215|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.11||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
73893216|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
73893217|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
73893218|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
73893219|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.39||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
73893220|NCT00488683|147319175|SUPERIORITY_OR_OTHER||R-square|0.33||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
73893221|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.24||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
73893222|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
73893223|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.52||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
73893224|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
73893225|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
73799522|NCT02440464|147146812|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 12 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
73799523|NCT02440464|147146812|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 18 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
73799524|NCT04620746|147146841|SUPERIORITY|||||||0.98|||||||Chi-squared, Corrected|||||||0.98
73799525|NCT04620746|147146842|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
73799526|NCT03535740|147146846|OTHER|||||||0.0763||||||P-value was based on the comparison of the confirm ORR among the 90/180mg group against a fixed response rate of 20%.|Exact Binomial Test|The calculation was based on an exact binomial test with a total 1-sided alpha level of 0.025 at primary analysis.||||||0.0763
73799527|NCT05807828|147146864|SUPERIORITY||Median Difference (Final Values)|7.5|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median difference between the cup angle of the Control Group for Cup Training and the cup angle of VR Group for Cup Training.||||<0.05
73799528|NCT05807828|147146864|SUPERIORITY||Median Difference (Final Values)|291.5|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median difference between the stem angle of the Control Group for Stem Training and the stem angle of VR Group for Stem Training.||||<0.05
73799529|NCT05807828|147146865|SUPERIORITY||Mean Difference (Final Values)|54.5|STANDARD_DEVIATION|106.6|<|0.05|TWO_SIDED||||||paired t-test|||Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student with VR training.||||<0.05
73799530|NCT05807828|147146865|SUPERIORITY||Mean Difference (Final Values)|89.8|STANDARD_DEVIATION|133.9|<|0.05|TWO_SIDED||||||paired t-test|||Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student without VR training (control).||||<0.05
73799531|NCT05807828|147146866|SUPERIORITY||Median Difference (Final Values)|14.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Median difference between the time needed for cup implantation for Control cup group and the time needed for cup implantation for VR cup group||||<0.05
73799532|NCT05807828|147146866|SUPERIORITY||Median Difference (Final Values)|2.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Median difference between the time needed for stem implantation for Control stem group and the time needed for stem implantation for VR stem group||||<0.05
73799533|NCT02756611|147146886|SUPERIORITY||||||<|0.001|||||||Binomial test|||The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be \> 6%. If the p-value for this test was \< 0.025, the null hypothesis would be rejected.||||<0.001
73799534|NCT02756611|147146897|SUPERIORITY||||||<|0.001|||||||Binomial test|||The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be \> 6%. If the p-value for this test was \< 0.025, the null hypothesis would be rejected.||||<0.001
73799535|NCT03135015|147146910|OTHER||Percentage Change from Control|-14.09||||0.1146|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.1146
73799536|NCT03135015|147146910|OTHER||Percentage Change from Control|-17.42||||0.0519|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.0519
73799537|NCT03135015|147146910|OTHER||Percentage Change from Control|-8.95|||||TWO_SIDED|||||||||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||
73799538|NCT03135015|147146911|OTHER|||||||0.1146|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons||||0.1146
73799539|NCT03135015|147146911|OTHER|||||||0.0519|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons||||0.0519
73799540|NCT03135015|147146912|OTHER|||||||0.5827|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5827
73799541|NCT03135015|147146912|OTHER|||||||0.5485|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5485
73799542|NCT03135015|147146913|OTHER||Percentage Change from Control|-8.53||||0.5827|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5827
73799543|NCT03135015|147146913|OTHER||Percentage Change from Control|9.32||||0.5485|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5485
73799544|NCT03135015|147146914|OTHER|||||||0.1234|||||||t-test, 2 sided|||||||0.1234
73799545|NCT03135015|147146914|OTHER|||||||0.0331|||||||t-test, 2 sided|||||||0.0331
73799546|NCT03135015|147146915|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.0500
73799547|NCT03135015|147146915|OTHER|||||||0.0568|||||||t-test, 2 sided|||||||0.0568
73799548|NCT03135015|147146916|OTHER|||||||0.0509|||||||t-test, 2 sided|||||||0.0509
73799549|NCT03135015|147146916|OTHER|||||||0.5016|||||||t-test, 2 sided|||||||0.5016
73799550|NCT03135015|147146917|OTHER|||||||0.8444|||||||t-test, 2 sided|||||||0.8444
73799551|NCT03135015|147146917|OTHER|||||||0.9681|||||||t-test, 2 sided|||||||0.9681
73799552|NCT03135015|147146917|OTHER|||||||0.1022|||||||t-test, 2 sided|||||||.1022
73799553|NCT03135015|147146917|OTHER|||||||0.3738|||||||t-test, 2 sided|||||||.3738
73799554|NCT03135015|147146917|OTHER||Mean Difference (Net)|-13.123|STANDARD_ERROR_OF_MEAN|8.55|||TWO_SIDED||||||||Percentage Change from Control|||||
73799555|NCT03135015|147146917|OTHER||Mean Difference (Net)|-10.362|STANDARD_ERROR_OF_MEAN|10.387|||TWO_SIDED||||||||Percentage Change from Control|||||
73799556|NCT03135015|147146917|OTHER||Mean Difference (Net)|-13.738|STANDARD_ERROR_OF_MEAN|13.463|||TWO_SIDED||||||||Percentage Change from Control|||||
73799557|NCT03135015|147146917|OTHER||Mean Difference (Net)|-12.929|STANDARD_ERROR_OF_MEAN|14.282|||TWO_SIDED||||||||Percentage Change from Control|||||
73799558|NCT03135015|147146918|OTHER|||||||0.0111|||||||t-test, 2 sided|||||||0.0111
73799559|NCT03135015|147146918|OTHER|||||||0.1684|||||||t-test, 2 sided|||||||0.1684
73799560|NCT03135015|147146918|OTHER||Mean Difference (Net)|-11.604|STANDARD_ERROR_OF_MEAN|6.722|||TWO_SIDED||||||||Percentage Change from Control|||||
73799561|NCT03135015|147146918|OTHER||Mean Difference (Net)|12.755|STANDARD_ERROR_OF_MEAN|8.489|||TWO_SIDED||||||||Percentage Change from Control|||||
73799562|NCT03135015|147146918|OTHER||Mean Difference (Net)|-13.293|STANDARD_ERROR_OF_MEAN|9.664|||TWO_SIDED||||||||Percentage Change from Control|||||
73799563|NCT03135015|147146918|OTHER||Mean Difference (Net)|2.526|STANDARD_ERROR_OF_MEAN|5.813|||TWO_SIDED||||||||Percentage Change from Control|||||
73799564|NCT03135015|147146919|OTHER||Percentage Change from Control|-21.09||||0.0374|TWO_SIDED||||||t-test, 2 sided|||||||0.0374
73799565|NCT03135015|147146920|OTHER||Percentage Change from Control|-24.22||||0.0098|TWO_SIDED||||||t-test, 2 sided|||||||0.0098
73799566|NCT03135015|147146920|OTHER||Percentage Change from Control|-25.02||||0.0391|TWO_SIDED||||||t-test, 2 sided|||||||0.0391
73799567|NCT03135015|147146921|OTHER||Percentage Change from Control|-36.28||||0.0034|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0034
73799568|NCT03135015|147146921|OTHER||Percentage Change from Control|-33.21||||0.0058|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0058
73799569|NCT03135015|147146921|OTHER||Percentage Change from Control|-53.27||||0.0016|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0016
73799570|NCT03135015|147146921|OTHER||Percentage Change from Control|-46.19||||0.0125|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0125
73799571|NCT03135015|147146922|OTHER||Percentage Change from Control|-31.36||||0.0788|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0788
73799572|NCT03135015|147146922|OTHER||Percentage Change from Control|-30.32||||0.0887|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0887
73799573|NCT03135015|147146922|OTHER||Percentage Change from Control|-39.96||||0.0266|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0266
73799574|NCT03135015|147146922|OTHER||Percentage Change from Control|-41.8||||0.0455|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0455
73799575|NCT03135015|147146923|OTHER||Percentage Change from Control|-41.82||||0.0261|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0261
73799576|NCT03135015|147146923|OTHER||Percentage Change from Control|-36.45||||0.0391|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0391
73799577|NCT03135015|147146923|OTHER||Percentage Change from Control|-82.11||||0.0372|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0372
73893226|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.29||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
73799578|NCT03135015|147146923|OTHER||Percentage Change from Control|-55.81||||0.1631|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.1631
73799579|NCT03135015|147146924|OTHER||Percentage Change from Control|-46.43||||0.0303|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0303
73799580|NCT03135015|147146924|OTHER||Percentage Change from Control|-19.64||||0.4283|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.4283
73799581|NCT04583735|147146926|SUPERIORITY||LSMean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.396||0.0004|TWO_SIDED|95.0|-2.28|-0.69||MMRM analysis with an unstructured variance-covariance matrix including change from Baseline value as dependent variable \& covariates: Baseline value, treatment group, visit, visit-by-treatment \& visit-by-Baseline value interactions.|MMRM|||||-0.69|-2.28|0.0004
73799582|NCT01197911|147146935|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.148|||||TWO_SIDED|90.0|0.9293|1.4182||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.4182|0.9293|
73799583|NCT01197911|147146935|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.5518|||||TWO_SIDED|90.0|1.2468|1.9314||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.9314|1.2468|
73799584|NCT01197911|147146937|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|0.9477|||||TWO_SIDED|90.0|0.7908|1.1356||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.1356|0.7908|
73799585|NCT01197911|147146937|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.0782|||||TWO_SIDED|90.0|0.8941|1.3002||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.3002|0.8941|
73799586|NCT01197911|147146951|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.2323|||||TWO_SIDED|90.0|0.9618|1.5789||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.5789|0.9618|
73799587|NCT01197911|147146951|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.5587|||||TWO_SIDED|90.0|1.2165|1.9971||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.9971|1.2165|
73799588|NCT01197911|147146952|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.0027|||||TWO_SIDED|90.0|0.8049|1.2492||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.2492|0.8049|
73799589|NCT01197911|147146952|SUPERIORITY_OR_OTHER||GeometricLeast-Squares Mean Ratio|1.2254|||||TWO_SIDED|90.0|0.9836|1.5266||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.5266|0.9836|
73799590|NCT02189837|147147025|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|88.76|STANDARD_ERROR_OF_MEAN|36.67||0.018|TWO_SIDED|95.0|15.73|161.8|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.||161.80|15.73|0.018
73799591|NCT02189837|147147025|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|236.35|STANDARD_ERROR_OF_MEAN|36.32|<|0.001|TWO_SIDED|95.0|164.02|308.69|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.||308.69|164.02|<0.001
73893227|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
73799592|NCT02189837|147147025|SUPERIORITY_OR_OTHER||Treatment Effect|147.59|STANDARD_ERROR_OF_MEAN|51.61||0.005|TWO_SIDED|95.0|44.8|250.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.||250.38|44.80|0.005
73799593|NCT02189837|147147026|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.14|STANDARD_ERROR_OF_MEAN|4.4|<|0.001||95.0|-65.91|-48.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-48.38|-65.91|<0.001
73799594|NCT02189837|147147026|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-37.95|STANDARD_ERROR_OF_MEAN|4.31|<|0.001|TWO_SIDED|95.0|-46.55|-29.34|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-29.34|-46.55|<0.001
73799595|NCT02189837|147147026|SUPERIORITY_OR_OTHER||Treatment Effect|19.2|STANDARD_ERROR_OF_MEAN|6.15||0.003|TWO_SIDED|95.0|6.93|31.47|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||31.47|6.93|0.003
73799596|NCT02189837|147147027|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.65|STANDARD_ERROR_OF_MEAN|10.41||0.11|TWO_SIDED|95.0|-37.37|4.08|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||4.08|-37.37|0.11
73799597|NCT02189837|147147027|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-32.66|STANDARD_ERROR_OF_MEAN|10.31||0.002|TWO_SIDED|95.0|-53.19|-12.13|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-12.13|-53.19|0.002
73799598|NCT02189837|147147027|SUPERIORITY_OR_OTHER||Treatment Effect|-16.01|STANDARD_ERROR_OF_MEAN|14.65||0.28|TWO_SIDED|95.0|-45.18|13.16|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||13.16|-45.18|0.28
73799599|NCT02189837|147147028|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-2.12|STANDARD_ERROR_OF_MEAN|13.4||0.87|TWO_SIDED|95.0|-28.94|24.7|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.||24.70|-28.94|0.87
73799600|NCT02189837|147147028|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|39.06|STANDARD_ERROR_OF_MEAN|12.76||0.003|TWO_SIDED|95.0|13.52|64.59|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.||64.59|13.52|0.003
73799601|NCT02189837|147147028|SUPERIORITY_OR_OTHER||Treatment Effect|41.18|STANDARD_ERROR_OF_MEAN|18.5||0.03|TWO_SIDED|95.0|4.15|78.2|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.||78.20|4.15|0.030
73799602|NCT02189837|147147029|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-39.43|STANDARD_ERROR_OF_MEAN|11.6||0.001|TWO_SIDED|95.0|-62.66|-16.21|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-16.21|-62.66|0.001
73799603|NCT02189837|147147029|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|23.28|STANDARD_ERROR_OF_MEAN|11.05||0.039|TWO_SIDED|95.0|1.16|45.4|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||45.40|1.16|0.039
73799604|NCT02189837|147147029|SUPERIORITY_OR_OTHER||Treatment Effect|62.72|STANDARD_ERROR_OF_MEAN|16.02|<|0.001|TWO_SIDED|95.0|30.65|94.79|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||94.79|30.65|<0.001
73799605|NCT02443740|147147055|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio.|39.58|||||TWO_SIDED|90.0|30.14|51.99|||||Values have been back-transformed from the log scale.|||51.99|30.14|
73799606|NCT02443740|147147056|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|80.6|||||TWO_SIDED|90.0|59.74|108.75|||||Values have been back-transformed from the log scale.|||108.75|59.74|
73799607|NCT02443740|147147057|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|80.12|||||TWO_SIDED|90.0|58.92|108.94|||||Values have been back-transformed from the log scale.|||108.94|58.92|
73799608|NCT02443740|147147062|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|65.58|||||TWO_SIDED|90.0|62.18|69.16|||||Values have been back-transformed from the log scale.|||69.16|62.18|
73799609|NCT02443740|147147063|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|68.62|||||TWO_SIDED|90.0|63.27|74.41|||||Values have been back-transformed from the log scale.|||74.41|63.27|
73799610|NCT02443740|147147064|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio.|29.76|||||TWO_SIDED|90.0|24.17|36.64|||||Values have been back-transformed from the log scale.|||36.64|24.17|
73799611|NCT02443740|147147066|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|16.71|||||TWO_SIDED|90.0|15.35|18.18|||||Values were back-transformed from the log scale.|||18.18|15.35|
73799612|NCT02443740|147147068|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|15.21|||||TWO_SIDED|90.0|13.29|17.42|||||Values were back-transformed from the log scale.|||17.42|13.29|
73799613|NCT01074944|147147081|NON_INFERIORITY_OR_EQUIVALENCE|Eliglustat QD treatment was declared non-inferior to BID treatment if the lower bound of the 95% confidence interval (CI) for the difference was within the non-inferiority margin of -0.15 (or -15%).|Difference in Percentage Stable|-2.7|||||TWO_SIDED|95.0|-17.7|11.9||||||||11.9|-17.7|
73893228|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
73893229|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.7||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
73893230|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
73893231|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.5||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
73893232|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.16||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
73893233|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
73893234|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.3||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
73893235|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
73893236|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.12||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
73893237|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.0015||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
73893238|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.0057||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
73799614|NCT02348112|147147117|NON_INFERIORITY|The number and proportion of subjects experiencing a 50% or greater reduction in pad weight at 6 months were compared, and non-inferiority assessed using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the 95% confidence interval for the difference in proportions (Comparator - Altis) was less than 0.15.|Difference in Proportions|-0.054||||0.013|TWO_SIDED|95.0|-0.139|0.031|||Normal approximation test (Z-test)|||||0.031|-0.139|0.013
73799615|NCT02348112|147147118|NON_INFERIORITY|The number and proportion of subjects experiencing device- and/or procedure-related serious adverse events were tabulated for each study group. Non-inferiority through 36 months was calculated using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the lower limit of the 95% confidence interval for the difference in proportions (Comparator - Altis) is greater than -0.10 in the mITT analysis population.|Difference in Proportions|0.013|||<|0.0001|TWO_SIDED|95.0|-0.023|0.048|||Normal approximation test (Z-test)|||||0.048|-0.023|<0.0001
73893239|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
73893240|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
73799616|NCT03741400|147147124|OTHER|||||||0.88||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in total seconds||||0.88
73799617|NCT03741400|147147124|OTHER|||||||0.99||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in fine motor skill assessment||||0.99
73799618|NCT03741400|147147124|OTHER|||||||0.8||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in gross motor skills assessment||||0.80
73893241|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.0048||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
73893242|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.0018||||||95.0|||||Regression, Linear||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
73893243|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
73893244|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
73893245|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.27||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
73893246|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
73893247|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
73893248|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
73893249|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.45||||0.0436||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||0.0436
73893250|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
73893251|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.37||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
73893252|NCT00488683|147319176|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
73799619|NCT03741400|147147125|OTHER|||||||0.61||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||||||0.61
73893253|NCT05475483|147319183|OTHER||Mean Difference (Final Values)|-1.27|||=|0.045|TWO_SIDED|95.0|-2.51|-0.03|||Mixed Models Analysis|||||-0.03|-2.51|= 0.045
73893254|NCT05475483|147319184|OTHER||Odds Ratio (OR)|2.22|||=|0.078|TWO_SIDED|95.0|0.91|5.37|||Regression, Logistic|||||5.37|0.91|= 0.078
73893255|NCT05475483|147319185|OTHER||Odds Ratio (OR)|1.95||||0.143|TWO_SIDED|95.0|0.8|4.76|||Regression, Logistic|||||4.76|0.80|0.143
73893256|NCT05475483|147319186|OTHER||Mean Difference (Final Values)|-1.78|||=|0.032|TWO_SIDED|95.0|-3.4|-0.16|||Mixed Models Analysis|||||-0.16|-3.40|= 0.032
73893257|NCT00459732|147319197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED|95.0|||||ANOVA|||||||0.13
73893258|NCT00459732|147319198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|TWO_SIDED|95.0|||||ANOVA|Repeated measures||||||0.44
73893259|NCT00459732|147319199|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED|95.0|||||ANCOVA|Repeated measures analysis of variance adjusted for baseline osteocalcin level.||||||0.16
73893260|NCT03983317|147319231|OTHER|We tested if the average drinks consumed was statistically different in Week 2 of the Treatment Phase vs. the Baseline Phase. This was evaluated via a paired t-test.||||||0.026|||||||t-test, 2 sided|Paired t-test||||||0.026
73893261|NCT03983317|147319233|OTHER|We tested if the average craving intensity was statistically different in Week 2 of the Treatment Phase vs. the Baseline Phase. This was evaluated via a paired t-test.||||||0.001|||||||t-test, 2 sided|Paired t-test||||||0.001
73893262|NCT00373113|147319303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.002|TWO_SIDED|95.0|1.156|1.869||2-sided log-rank test with the same set of stratification factors. The set of stratification factors included those used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.|Null hypothesis is that PFS (median=4.2 months) for sunitinib arm equals PFS for capecitabine arm. The study was designed to have 90% power to detect statistical difference in PFS between two treatment groups assuming the hazard ratio (sunitinib/capecitabine) is 0.75 and both arms follow exponential distribution.||1.869|1.156|0.002
73799620|NCT03741400|147147126|OTHER|||||||0.47||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in total seconds||||0.47
73799621|NCT03741400|147147126|OTHER|||||||0.55||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in fine motor skill assessment||||0.55
73893263|NCT00373113|147319304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.516|||<|0.001|TWO_SIDED|95.0|1.188|1.933||2-sided log-rank test with the same set of stratification factors that was used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.|||1.933|1.188|<0.001
73893264|NCT00373113|147319305|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|11.3|||||TWO_SIDED|95.0|7.6|16.1||||||||16.1|7.6|
73893265|NCT00373113|147319305|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|16.4|||||TWO_SIDED|95.0|12.0|21.6||||||||21.6|12.0|
73893266|NCT00373113|147319305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.049||||0.109|TWO_SIDED|95.0|-11.2|1.1|||Pearson Chi-Square Test|||||1.1|-11.2|0.109
73893267|NCT00373113|147319306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.788||||0.037|TWO_SIDED|95.0|1.042|7.459|||Log Rank|||||7.459|1.042|0.037
73893268|NCT00373113|147319308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.219|TWO_SIDED|95.0|0.896|1.611||2-sided log-rank test with the same set of stratification factors that were used in the randomization except study sites.|Log Rank|||||1.611|0.896|0.219
73893269|NCT04248491|147319311|SUPERIORITY|||||||0.342|||||||t-test, 2 sided|||||||0.342
73893270|NCT04248491|147319312|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
73893271|NCT04248491|147319314|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
73893272|NCT04248491|147319316|SUPERIORITY|||||||0.192|||||||t-test, 2 sided|||||||0.192
73893273|NCT04248491|147319317|SUPERIORITY|||||||0.157|||||||t-test, 2 sided|||||||0.157
73893274|NCT04248491|147319318|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.00
73893275|NCT04248491|147319319|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
73893276|NCT04248491|147319320|SUPERIORITY|||||||0.799|||||||t-test, 2 sided|||||||0.799
73893277|NCT04248491|147319321|SUPERIORITY|||||||0.757|||||||t-test, 2 sided|||||||0.757
73893278|NCT04248491|147319322|SUPERIORITY|||||||0.472|||||||t-test, 2 sided|||||||0.472
73893279|NCT04248491|147319324|SUPERIORITY|||||||0.342|||||||t-test, 2 sided|||||||0.342
73893280|NCT00856518|147319357|SUPERIORITY_OR_OTHER|||||||0.899||||||EMST arm vs. Sham arm baseline MEP value comparison|Wilcoxon (Mann-Whitney)|||||||0.899
73799622|NCT03741400|147147126|OTHER|||||||0.38||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in gross motor skills assessment||||0.38
73799623|NCT03741400|147147127|OTHER|||||||0.24||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||||||0.24
73799624|NCT03741400|147147128|OTHER|||||||0.18||||||A priori threshold for statistical significance, 0.05|Mann-Whitney U test|||||||0.18
73799625|NCT03741400|147147129|OTHER|||||||0.926||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis at week 12||||0.926
73799626|NCT03741400|147147129|OTHER|||||||0.828||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis at week 24||||0.828
73799627|NCT03714828|147147138|OTHER||Overall Response Rate|100.0||||0.0005|ONE_SIDED|95.0|76.2||||One-sample binomial test|One-sample binomial test versus null hypothesis value of 0.50.|||||76.2|0.0005
73799628|NCT03714828|147147140|OTHER|Descriptive statistics|Mean|48.7|STANDARD_DEVIATION|29.2|||TWO_SIDED|||||||||||||
73799629|NCT03714828|147147142|OTHER|Binomial proportion of TILs|Percentage|83.3|||||TWO_SIDED|||||||||||||
73799630|NCT03714828|147147145|OTHER|Counts of TILs|Percentage|100.0|||||TWO_SIDED|||||||||||||
73799631|NCT03714828|147147146|OTHER||Percentage|100.0|||||TWO_SIDED|||||||||||||
73799632|NCT01998841|147147148|SUPERIORITY||Difference in Annualized Rate of Change|0.33|STANDARD_ERROR_OF_MEAN|0.41||0.43|TWO_SIDED|95.0|-0.48|1.13|||RCRM|||Analysis was based on random coefficient regression model (RCRM) using unstructured covariance matrix: API Composite Endpoint=Treatment \* Analysis Year + interactive voice or Web-based response system (IxRS) defined Age Group + IxRS defined Education History + IxRS defined apolipoprotein E4 (APOE4) Carrier Status + IxRS defined CDR Global Score.||1.13|-0.48|0.43
73799633|NCT01998841|147147149|SUPERIORITY||Difference in Annualized Rate of Change|0.008|STANDARD_ERROR_OF_MEAN|0.006||0.16|TWO_SIDED|95.0|-0.003|0.02|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: FCSRT Cueing Index = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.02|-0.003|0.16
73799634|NCT01998841|147147150|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.48|TWO_SIDED|95.0|0.41|1.52|||Stratified Log Rank||Hazard ratios were estimated by Cox regression|Stratification factors used: Age Group, Education History, APOE4 Carrier Status, Clinical Dementia Rating (CDR) Global Score.||1.52|0.41|0.48
73799635|NCT01998841|147147151|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.76|TWO_SIDED|95.0|0.53|1.59|||Stratified Log Rank||Hazard ratios were estimated by Cox regression.|Stratification factors used: Age Group, Education History, APOE4 Carrier Status.||1.59|0.53|0.76
73799636|NCT01998841|147147152|SUPERIORITY||Difference in Annualized Rate of Change|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.64|TWO_SIDED|95.0|-0.15|0.09|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: CDR-SB = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.09|-0.15|0.64
73799637|NCT01998841|147147153|SUPERIORITY||Difference in Annualized Rate of Change|0.18|STANDARD_ERROR_OF_MEAN|0.29||0.55|TWO_SIDED|95.0|-0.4|0.75|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: RBANS Total Score = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.75|-0.40|0.55
73799638|NCT01998841|147147154|SUPERIORITY||Difference in Annualized Rate of Change|-0.0006|STANDARD_ERROR_OF_MEAN|0.002||0.69|TWO_SIDED|95.0|-0.0037|0.0024|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: PET SUVR = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.0024|-0.0037|0.69
73799639|NCT01998841|147147155|SUPERIORITY||Difference in Annualized Rate of Change|0.003|STANDARD_ERROR_OF_MEAN|0.002||0.25|TWO_SIDED|95.0|-0.002|0.007|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: FDG-PET = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.007|-0.002|0.25
73799640|NCT01998841|147147156|SUPERIORITY||Difference in Annualized Rate of Change|107.78|STANDARD_ERROR_OF_MEAN|92.28||0.25|TWO_SIDED|95.0|-74.5|290.05|||RCRM|||Whole Brain: Analysis was based on RCRM using unstructured covariance matrix: MRI Whole Brain (Derived) = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||290.05|-74.5|0.25
73799641|NCT01998841|147147156|SUPERIORITY||Difference in Annualized Rate of Change|9.6|STANDARD_ERROR_OF_MEAN|17.39||0.58|TWO_SIDED|95.0|-24.74|43.94|||RCRM|||Bilateral Hippocampus: Analysis was based on RCRM using unstructured covariance matrix: MRI Bilateral Hippocampus = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||43.94|-24.74|0.58
73799642|NCT01998841|147147156|SUPERIORITY||Difference in Annualized Rate of Change|19.92|STANDARD_ERROR_OF_MEAN|213.08||0.93|TWO_SIDED|95.0|-400.78|440.62|||RCRM|||Ventricles: Analysis was based on RCRM using unstructured covariance matrix: MRI Ventricles = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||440.62|-400.78|0.93
73799643|NCT01998841|147147157|SUPERIORITY||Difference in Annualized Rate of Change|-1.97|STANDARD_ERROR_OF_MEAN|3.09||0.53|TWO_SIDED|95.0|-8.17|4.23|||RCRM|||tTau: Analysis was based on RCRM using unstructured covariance matrix: CSF tTau = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||4.23|-8.17|0.53
73893281|NCT00856518|147319357|SUPERIORITY_OR_OTHER|||||||0.946|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response||||||0.946
73893282|NCT00856518|147319357|SUPERIORITY_OR_OTHER|||||||0.00042|||||||t-test, 2 sided|EMST arm post vs. pre-MEP comparison||||||0.00042
73893283|NCT00856518|147319357|SUPERIORITY_OR_OTHER|||||||0.0019||||||Sham arm post vs. pre-MEP comparison|t-test, 2 sided|||||||0.0019
73893284|NCT00856518|147319359|SUPERIORITY_OR_OTHER||||||>|0.05||||||EMST arm vs. Sham arm baseline total score and subscale score comparison|Wilcoxon (Mann-Whitney)|||||||> 0.05
73799644|NCT01998841|147147157|SUPERIORITY||Difference in Annualized Rate of Change|-0.5|STANDARD_ERROR_OF_MEAN|0.46||0.28|TWO_SIDED|95.0|-1.43|0.43|||RCRM|||pTau: Analysis was based on RCRM using unstructured covariance matrix: CSF pTau = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.43|-1.43|0.28
73799645|NCT01998841|147147165|SUPERIORITY||Difference in Annualized Rate of Change|7522.55|STANDARD_ERROR_OF_MEAN|313.17|<|0.0001|TWO_SIDED|95.0|6903.44|8141.65|||RCRM|||Aβ1-40: Analysis was based on RCRM using unstructured covariance matrix: APlasma Amyloid Beta 1-40 =Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||8141.65|6903.44|<0.0001
73799646|NCT01998841|147147165|SUPERIORITY||Difference in Annualized Rate of Change|556.03|STANDARD_ERROR_OF_MEAN|23.98|<|0.0001|TWO_SIDED|95.0|508.63|603.44|||RCRM|||Aβ1-42: Analysis was based on RCRM using unstructured covariance matrix: Plasma Amyloid Peptid Beta 42 =Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||603.44|508.63|<0.0001
73799647|NCT03093259|147147230|OTHER|One-sided 10% significance level||||||0.2096|||||||Chi-squared|||||||0.2096
73799648|NCT03093259|147147231|OTHER|||||||0.1588|||||||Chi-squared|||||||0.1588
73799649|NCT03093259|147147232|OTHER|||||||0.483|||||||ANCOVA|||||||0.4830
73799650|NCT03093259|147147233|OTHER|||||||0.0742|||||||ANCOVA|||||||0.0742
73799651|NCT03093259|147147234|OTHER|||||||0.0462|||||||ANCOVA|||||||0.0462
73799652|NCT02575833|147147235|NON_INFERIORITY|The non-inferiority margin was -90 seconds.|Treatment Difference|-11.0|STANDARD_ERROR_OF_MEAN|20.4|||TWO_SIDED|90.0|-44.9|22.9||||||The primary endpoint was analyzed using an analysis of variance model with terms for treatment group and randomization strata (\< 7 or ≥ 7 minutes). If the lower bound of the 90% confidence interval (CI) of the difference in change from baseline in exercise duration was above the non-inferiority margin of -90 seconds, then the hypothesis that erenumab does not decrease exercise duration would be supported.||22.9|-44.9|
73799653|NCT02575833|147147236|SUPERIORITY|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|1.55||||0.69|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (\< 7 minutes or ≥ 7 minutes).|A normal score \< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.|||||0.69
73799654|NCT02575833|147147236|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.69|TWO_SIDED|90.0|0.73|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (\< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.69|0.73|0.69
73799655|NCT02575833|147147236|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.44|TWO_SIDED|90.0|0.52|1.26|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.26|0.52|0.44
73799656|NCT02575833|147147236|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.47|TWO_SIDED|90.0|0.52|1.28|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (\< 7 or ≥ 7 minutes), age group (\< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.28|0.52|0.47
73799657|NCT02575833|147147237|SUPERIORITY|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|2.2||||0.59|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (\< 7 minutes or ≥ 7 minutes).|A normal score \< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.|||||0.59
73799658|NCT02575833|147147237|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.59|TWO_SIDED|90.0|0.76|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (\< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.69|0.76|0.59
73799659|NCT02575833|147147237|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.75|TWO_SIDED|90.0|0.73|1.6|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.60|0.73|0.75
73799660|NCT02575833|147147237|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.39|TWO_SIDED|90.0|0.82|1.87|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (\< 7 or ≥ 7 minutes), age group (\< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.87|0.82|0.39
73799661|NCT00967330|147147257|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
73799662|NCT00967330|147147258|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.588||||0.0012|TWO_SIDED|95.0|0.423|0.817|||Chi-squared|||||0.817|0.423|0.0012
73799663|NCT00967330|147147259|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.8283|TWO_SIDED|95.0|0.684|1.354|||Chi-squared|||||1.354|0.684|0.8283
73799664|NCT00967330|147147261|SUPERIORITY_OR_OTHER||Difference in response rate|0.06||||0.34745|TWO_SIDED|95.0|-0.02|0.14|||Fisher Exact|||Response rate based on participants with CR at 4 weeks after RT.||0.14|-0.02|0.34745
73799665|NCT00967330|147147261|SUPERIORITY_OR_OTHER||Difference in response rate|0.09||||0.17923|TWO_SIDED|95.0|0.0|0.17|||Fisher Exact|||The response rate based on participants with CR at \>4 weeks after RT.||0.17|0.00|0.17923
73799666|NCT00967330|147147261|SUPERIORITY_OR_OTHER||Difference in response rate|0.0||||1|TWO_SIDED|95.0|-0.08|0.08|||Fisher Exact|||The response rate based on participants with CR at Month 6.||0.08|-0.08|1.00000
73799667|NCT00967330|147147261|SUPERIORITY_OR_OTHER||Difference in response rate|0.25||||0.0021|TWO_SIDED|95.0|0.12|0.38|||Fisher Exact|||Response rate based on participants with CR or PR at 4 weeks after RT.||0.38|0.12|0.00210
73799668|NCT00967330|147147261|SUPERIORITY_OR_OTHER||Difference in response rate|0.1||||0.18761|TWO_SIDED|95.0|-0.02|0.23|||Fisher Exact|||Response rate based on participants with CR and PR at \>4 weeks after RT.||0.23|-0.02|0.18761
73799669|NCT00967330|147147261|SUPERIORITY_OR_OTHER||Difference in response rate|-0.05||||0.38974|TWO_SIDED|95.0|-0.18|0.07|||Fisher Exact|||Response rate based on participants with CR or PR at Month 6.||0.07|-0.18|0.38974
73799670|NCT00967330|147147263|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|2.1002||||0.4975|TWO_SIDED|95.0|-3.9855|8.186|||ANOVA|||Physical Functioning. Analysis of variance (ANOVA) included all post-baseline data (Months 3 through 21).||8.1860|-3.9855|0.4975
73799671|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4704||||0.76|TWO_SIDED|95.0|-10.9358|7.9951|||ANOVA|||Role Functioning. ANOVA included all post-baseline data (Months 3 through 21).||7.9951|-10.9358|0.7600
73799672|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02278||||0.9949|TWO_SIDED|95.0|-7.035|6.9895|||ANOVA|||Emotional Functioning. ANOVA included all post-baseline data (Months 3 through 21).||6.9895|-7.0350|0.9949
73799673|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8213||||0.6253|TWO_SIDED|95.0|-9.155|5.5125|||ANOVA|||Cognitive Functioning. ANOVA included all post-baseline data (Months 3 through 21).||5.5125|-9.1550|0.6253
73799674|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6126||||0.7219|TWO_SIDED|95.0|-7.2953|10.5205|||ANOVA|||Social Functioning. ANOVA included all post-baseline data (Months 3 through 21).||10.5205|-7.2953|0.7219
73799675|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4989||||0.2443|TWO_SIDED|95.0|-2.4046|9.4023|||ANOVA|||Global Health Status /QoL. ANOVA included all post-baseline data (Months 3 through 21).||9.4023|-2.4046|0.2443
73799676|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3449||||0.3287|TWO_SIDED|95.0|-10.0739|3.3841|||ANOVA|||Fatigue. ANOVA included all post-baseline data (Months 3 through 21).||3.3841|-10.0739|0.3287
73799677|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.196||||0.0485|TWO_SIDED|95.0|-8.3635|-0.0285|||ANOVA|||Nausea/Vomiting. ANOVA included all post-baseline data (Months 3 through 21).||-0.02850|-8.3635|0.0485
73799678|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.095||||0.0354|TWO_SIDED|95.0|-17.5629|-0.6271|||ANOVA|||Pain. ANOVA included all post-baseline data (Months 3 through 21).||-0.6271|-17.5629|0.0354
73799679|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2088||||0.3724|TWO_SIDED|95.0|-10.2784|3.8608|||ANOVA|||Dyspnoea. ANOVA included all post-baseline data (Months 3 through 21).||3.8608|-10.2784|0.3724
73799680|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.876||||0.2884|TWO_SIDED|95.0|-13.9002|4.1482|||ANOVA|||Insomnia. ANOVA included all post-baseline data (Months 3 through 21).||4.1482|-13.9002|0.2884
73799681|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.782||||0.4081|TWO_SIDED|95.0|-9.3926|3.8282|||ANOVA|||Appetite loss. ANOVA included all post-baseline data (Months 3 through 21).||3.8282|-9.3926|0.4081
73799682|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9375||||0.275|TWO_SIDED|95.0|-11.0245|3.1495|||ANOVA|||Constipation. ANOVA included all post-baseline data (Months 3 through 21).||3.1495|-11.0245|0.2750
73799683|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1685||||0.0213|TWO_SIDED|95.0|-11.4129|-0.9241|||ANOVA|||Diarrhoea. ANOVA included all post-baseline data (Months 3 through 21).||-0.9241|-11.4129|0.0213
73799684|NCT00967330|147147263|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7295||||0.5201|TWO_SIDED|95.0|-11.0727|5.6137|||ANOVA|||Financial Problems. ANOVA included all post-baseline data (Months 3 through 21).||5.6137|-11.0727|0.5201
73799685|NCT00967330|147147264|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2699||||0.3613|TWO_SIDED|95.0|-10.2983|3.7585|||ANOVA|||Future uncertainty. ANOVA included all post-baseline data (Months 3 through 21).||3.7585|-10.2983|0.3613
73799686|NCT00967330|147147264|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1159||||0.6146|TWO_SIDED|95.0|-5.4654|3.2336|||ANOVA|||Visual disorder. ANOVA included all post-baseline data (Months 3 through 21).||3.2336|-5.4654|0.6146
73799687|NCT00967330|147147264|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1014||||0.686|TWO_SIDED|95.0|-4.2449|6.4477|||ANOVA|||Motor dysfunction. ANOVA included all post-baseline data (Months 3 through 21).||6.4477|-4.2449|0.6860
73799688|NCT00967330|147147264|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1009||||0.9706|TWO_SIDED|95.0|-5.468|5.2663|||ANOVA|||Communication deficit. ANOVA included all post-baseline data (Months 3 through 21).||5.2663|-5.4680|0.9706
73799689|NCT00967330|147147264|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.3294||||0.0124|TWO_SIDED|95.0|-14.855|-1.8037|||ANOVA|||Headaches. ANOVA included all post-baseline data (Months 3 through 21).||-1.8037|-14.8550|0.0124
73799690|NCT00967330|147147264|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0054||||0.5997|TWO_SIDED|95.0|-4.7654|2.7545|||ANOVA|||Seizures. ANOVA included all post-baseline data (Months 3 through 21).||2.7545|-4.7654|0.5997
73799691|NCT00967330|147147264|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4399||||0.3458|TWO_SIDED|95.0|-10.6002|3.7204|||ANOVA|||Drowsiness. ANOVA included all post-baseline data (Months 3 through 21).||3.7204|-10.6002|0.3458
73799692|NCT00967330|147147264|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5908||||0.2383|TWO_SIDED|95.0|-12.2279|3.0464|||ANOVA|||Hair loss. ANOVA included all post-baseline data (Months 3 through 21).||3.0464|-12.2279|0.2383
73799693|NCT00967330|147147264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9807||||0.7491|TWO_SIDED|95.0|-5.0373|6.9988|||ANOVA|||Itchy skin. ANOVA included all post-baseline data (Months 3 through 21).||6.9988|-5.0373|0.7491
73799694|NCT00967330|147147264|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0341||||0.7755|TWO_SIDED|95.0|-8.1508|6.0827|||ANOVA|||Weakness of legs. ANOVA included all post-baseline data (Months 3 through 21).||6.0827|-8.1508|0.7755
73799695|NCT00967330|147147264|SUPERIORITY_OR_OTHER||LS Mean Difference|0.469||||0.841|TWO_SIDED|95.0|-4.1211|5.0591|||ANOVA|||Bladder control. ANOVA included all post-baseline data (Months 3 through 21).||5.0591|-4.1211|0.8410
73799696|NCT00967330|147147265|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1933||||0.0817|TWO_SIDED|95.0|-0.411|0.02438|||ANOVA|||Orientation to time and place. ANOVA included all post-baseline data (Months 3 through 21).||0.02438|-0.4110|0.0817
73799697|NCT00967330|147147265|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02955||||0.0773|TWO_SIDED|95.0|-0.06234|0.003241|||ANOVA|||Immediate recall. ANOVA included all post-baseline data (Months 3 through 21).||0.003241|-0.06234|0.0773
73799698|NCT00967330|147147265|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1429||||0.2608|TWO_SIDED|95.0|-0.1065|0.3924|||ANOVA|||Repetitions required. ANOVA included all post-baseline data (Months 3 through 21).||0.3924|-0.1065|0.2608
73893285|NCT00856518|147319359|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response for total score and all subscale scores except for Burden and Pharyngeal domains||||||> 0.05
73893286|NCT00856518|147319359|SUPERIORITY_OR_OTHER|||||||0.014|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response in Burden domain||||||0.014
73893287|NCT00856518|147319359|SUPERIORITY_OR_OTHER|||||||0.022|||||||Plum Ordinal Regression test|EMST arm vs. Sham arm group comparison of treatment response in Pharyngeal domain||||||0.022
73893288|NCT00856518|147319359|SUPERIORITY_OR_OTHER||||||>|0.05||||||Sham arm post vs. pre-treatment comparison for the total SWAL-QOL score and subscale scores except for the Burden and Mental Health domains.|Wilcoxon Signed Ranks Test|||||||>0.05
73893289|NCT00856518|147319359|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Burden domain||||||0.038
73799699|NCT00967330|147147265|SUPERIORITY_OR_OTHER||LS Mean Difference|0.003262||||0.9836|TWO_SIDED|95.0|-0.3092|0.3158|||ANOVA|||Calculations. ANOVA included all post-baseline data (Months 3 through 21).||0.3158|-0.3092|0.9836
73893290|NCT00856518|147319359|SUPERIORITY_OR_OTHER|||||||0.031|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Mental Health domain||||||0.031
73893291|NCT00856518|147319359|SUPERIORITY_OR_OTHER|||||||0.027|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Burden domain||||||0.027
73893292|NCT00856518|147319359|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Mental Health domain||||||0.016
73893293|NCT00856518|147319359|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Pharyngeal domain||||||0.007
73893294|NCT00856518|147319359|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Saliva domain||||||0.036
73893295|NCT00856518|147319359|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Fear domain||||||0.004
73799700|NCT00967330|147147265|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03782||||0.661|TWO_SIDED|95.0|-0.2071|0.1315|||ANOVA|||Short-term verbal memory. ANOVA included all post-baseline data (Months 3 through 21).||0.1315|-0.2071|0.6610
73799701|NCT00967330|147147265|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08037||||0.4464|TWO_SIDED|95.0|-0.2875|0.1268|||ANOVA|||Language and construct ability. ANOVA included all post-baseline data (Months 3 through 21).||0.1268|-0.2875|0.4464
73799702|NCT00967330|147147265|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3128||||0.4717|TWO_SIDED|95.0|-1.1658|0.5402|||ANOVA|||Total score. ANOVA included all post-baseline data (Months 3 through 21).||0.5402|-1.1658|0.4717
73799703|NCT00967330|147147266|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.151||||0.2078|TWO_SIDED|95.0|-5.4983|1.1963|||ANOVA|||KPS score. ANOVA included all post-baseline data (Months 3 through 21).||1.1963|-5.4983|0.2078
73799704|NCT03759392|147147269|SUPERIORITY||Least squares mean difference|-0.447|STANDARD_ERROR_OF_MEAN|0.2931||0.13|TWO_SIDED|95.0|-1.024|0.131|||ANCOVA|Using multiple imputation||||0.131|-1.024|0.13
73799705|NCT03759392|147147270|SUPERIORITY||Least squares mean difference|-5.388|STANDARD_ERROR_OF_MEAN|2.3937||0.025|TWO_SIDED|95.0|-10.108|-0.0668|||ANCOVA|Using multiple imputation||||-0.0668|-10.108|0.025
73893296|NCT00856518|147319359|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Total SWAL-QOL score||||||0.016
73893297|NCT03364270|147319367|OTHER||Mean Difference (Final Values)|0.58||||0.001|TWO_SIDED|95.0|0.33|0.84||Threshold p\<0.05|t-test, 2 sided|||Null hypothesis: There is no difference in mean 18F-RGD uptake (expressed as a target to background ratio) in the culprit artery (carotid artery implicated in stroke or transient ischemic attack \[TIA\]) when compared to mean 18F-RGD uptake in the contralateral carotid artery. A paired t-test was used to compare 18F-RGD uptake in culprit plaque to plaque in the contralateral artery.||0.84|0.33|.001
73893298|NCT00926029|147319369|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73893299|NCT00926029|147319370|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73893300|NCT04154189|147319381|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0396|TWO_SIDED|95.0|0.27|1.08||One-sided P value|Log Rank||Hazard ratio was based on Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (less than \[\<\]18 years, more than or equal to \[\>=\]18 years) in interactive response technology (IRT). Efron method was used for ties.|||1.08|0.27|0.0396
73893301|NCT04154189|147319382|OTHER|Difference in PFS rates, and 2-sided 95% confidence intervals (CIs): CI and p-value constructed using the difference of the 2 Kaplan-Meier PFS rates (4 months) and the 2 corresponding Greenwood standard errors.|Difference in Percentage|10.2||||0.1683|TWO_SIDED|95.0|-10.6|31.1||One-sided P value|Kaplan-Meier Method|||||31.1|-10.6|0.1683
73893302|NCT04154189|147319384|OTHER||Hazard Ratio (HR)|0.93||||0.3924|TWO_SIDED|95.0|0.53|1.62||Nominal p-value from stratified log-rank test adjusted for the randomization stratification factor, that is, age.|Stratified Log-rank One-sided Test||Hazard ratio was based on a Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (\<18 years, \>=18 years) in IRT. Efron method was used for ties.|||1.62|0.53|0.3924
73893303|NCT04154189|147319385|OTHER|Difference and 95% CI: difference of 2 Kaplan-Meier OS-1y rates and corresponding Greenwood standard errors.|Difference in Percentage|-22.9||||0.0352|TWO_SIDED|95.0|-47.6|1.9||One-sided P value|Kaplan Meier Method|||||1.9|-47.6|0.0352
73893304|NCT04154189|147319386|OTHER|Difference calculated as Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide minus Treatment Arm B: Ifosfamide + Etoposide. 2-sided 95% CI: Miettinen-Nurminen (Score) confidence limits, stratified by randomization stratification factor age (\<18 and \>=18 years).|Difference in Percentage|7.7|||||TWO_SIDED|95.0|-6.4|22.3||||||||22.3|-6.4|
73893305|NCT04154189|147319387|OTHER|Difference calculated as Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide minus Treatment Arm B: Ifosfamide + Etoposide. 2-sided 95% CI: Miettinen-Nurminen (Score) confidence limits, stratified by randomization stratification factor age (\<18 and \>=18 years).|Difference in Percentage|5.2|||||TWO_SIDED|95.0|-10.3|20.0||||||||20.0|-10.3|
73893306|NCT00486291|147319393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||It is anticipated that the pooled standard deviation (SD) of the change from baseline in HbA1c will be between 1.0 and 1.5. With 90 subjects per treatment group the study will have 90% power (two-sided alpha=0.05) to detect a mean difference between groups of 0.486 for SD=1.0, and a mean difference between groups of 0.729 for SD=1.5.||-0.2|-0.9|0.0007
73893307|NCT00486291|147319394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-8.1|-4.9|||ANCOVA|||||-4.9|-8.1|<0.0001
73893308|NCT01056016|147319402|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.4|||=|0.003|TWO_SIDED||||||t-test, 2 sided|||The percentage of patients with whom pediatrician in each group utilized each practice behavior at baseline and 6-months was computed. The reported statistical analysis did not account potential clustering due to the small number of practices in this study.||||=.003
73893309|NCT03051178|147319403|SUPERIORITY||||||<|0.01||||||All post-hoc comparisons were Bonferroni corrected.|ANOVA|||TRS scores measured across different stimulation conditions were assessed using a mixed model ANOVA with the participant as a random effect. All post-hoc comparisons were Bonferroni corrected.||||<0.01
73893310|NCT00312195|147319431|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79|STANDARD_ERROR_OF_MEAN|0.2544||0.0217|TWO_SIDED|95.0|1.09|2.95||P value is from a logistic regression analysis with terms for treatment effect, country and pain site (hip, knee, back and other).|Regression, Logistic||Primary variable was defined as: ratio of the probability of having ineffective treatment divided by the probability of having effective treatment.|H0: the odds of ineffective treatment is the same for subjects receiving placebo as for those receiving BTDS versus the alternative H1: the odds of ineffective treatment is different for subjects receiving placebo from those receiving BTDS.||2.95|1.09|.0217
73893311|NCT02511106|147319435|SUPERIORITY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.18|0.3|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.30|0.18|<0.0001
73893312|NCT02511106|147319436|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.21|0.34|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.34|0.21|<0.0001
73893313|NCT02511106|147319439|SUPERIORITY||Hazard Ratio (HR)|0.4913||||0.0004|TWO_SIDED|95.03|0.3307|0.7299|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.7299|0.3307|0.0004
73893314|NCT02511106|147319440|SUPERIORITY||Hazard Ratio (HR)|0.4912|||<|0.0001|TWO_SIDED|95.03|0.3439|0.7017|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.7017|0.3439|<0.0001
73893315|NCT02657408|147319447|EQUIVALENCE|confirmatory statistical hypothesis tested|Geometric mean ratio (%)|1.27||||0.3043|TWO_SIDED|90.0|0.86|1.87|||ANOVA|||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.87|0.86|0.3043
73893316|NCT02657408|147319448|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.01|||||TWO_SIDED|90.0|0.88|1.16||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.16|0.88|
73893317|NCT02657408|147319449|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.54|||||TWO_SIDED|90.0|0.59|4.03||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||4.03|0.59|
73893318|NCT02657408|147319450|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.17|||||TWO_SIDED|90.0|0.49|2.85||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||2.85|0.49|
73893319|NCT02657408|147319451|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.29|||||TWO_SIDED|90.0|0.91|1.83||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.83|0.91|
73893320|NCT02657408|147319452|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.03|||||TWO_SIDED|90.0|0.9|1.18||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.18|0.90|
73893321|NCT02657408|147319453|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.18|||||TWO_SIDED|90.0|0.91|1.53||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.53|0.91|
73799706|NCT03759392|147147271|SUPERIORITY||Least squares mean difference|0.414|STANDARD_ERROR_OF_MEAN|0.6215||0.51|TWO_SIDED|95.0|-0.81|1.639|||ANCOVA|Using multiple imputation||||1.639|-0.810|0.51
73799707|NCT03759392|147147272|SUPERIORITY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.42||0.54|TWO_SIDED|95.0|-0.6|1.1|||Repeated measures mixed model|||||1.1|-0.6|0.54
73799708|NCT02623725|147147273|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95 percent (%) Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (\>) 1/2 for each serotype.|Geometric mean of titer ratio|1.66|||||TWO_SIDED|95.0|1.33|2.06||||||Dengue Virus Serotype 1||2.06|1.33|
73893322|NCT02657408|147319454|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.94|||||TWO_SIDED|90.0|0.8|1.09||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.09|0.80|
73893323|NCT02657408|147319455|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.81|||||TWO_SIDED|90.0|0.51|1.28||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.28|0.51|
73893324|NCT02657408|147319456|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.64|||||TWO_SIDED|90.0|0.43|0.97||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||0.97|0.43|
73893325|NCT01247272|147319553|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|113.36|||||TWO_SIDED|90.0|108.03|118.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||118.96|108.03|
73799709|NCT02623725|147147273|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.82|||||TWO_SIDED|95.0|1.43|2.31||||||Dengue Virus Serotype 2||2.31|1.43|
73799710|NCT02623725|147147273|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.04|||||TWO_SIDED|95.0|0.841|1.27||||||Dengue Virus Serotype 3||1.27|0.841|
73799711|NCT02623725|147147273|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.32|||||TWO_SIDED|95.0|1.01|1.74||||||Dengue Virus Serotype 4||1.74|1.01|
73799712|NCT02623725|147147274|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.66|||||TWO_SIDED|95.0|1.34|2.05||||||Dengue Virus Serotype 1||2.05|1.34|
73893326|NCT01247272|147319554|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.78|||||TWO_SIDED|90.0|102.18|113.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||113.69|102.18|
73799713|NCT02623725|147147274|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.89|||||TWO_SIDED|95.0|1.49|2.41||||||Dengue Virus Serotype 2||2.41|1.49|
73799714|NCT02623725|147147274|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.06|||||TWO_SIDED|95.0|0.86|1.3||||||Dengue Virus Serotype 3||1.30|0.860|
73799715|NCT02623725|147147274|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.33|||||TWO_SIDED|95.0|1.02|1.73||||||Dengue Virus Serotype 4||1.73|1.02|
73799716|NCT01243957|147147287|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.79|||||TWO_SIDED|90.0|1.61|2.0|||ANOVA|||||2.00|1.61|
73799717|NCT01243957|147147288|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.63|||||TWO_SIDED|90.0|1.49|1.79|||ANOVA|||||1.79|1.49|
73799718|NCT01243957|147147289|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5459|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.50|-0.50|0.5459
73799719|NCT01243957|147147290|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.99|1.04|||ANOVA|||Ratio of Geometric LS Means of AUCτ for fluoxetine alone and fluoxetine + LY2216684.||1.04|0.99|
73799720|NCT01243957|147147290|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.01|1.06|||ANOVA|||Ratio of Geometric LS Means of AUCτ for norfluoxetine alone and norfluoxetine + LY2216684.||1.06|1.01|
73799721|NCT01243957|147147291|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.0|||||TWO_SIDED|90.0|0.97|1.03|||ANOVA|||Ratio of Geometric LS Means of Cmax for fluoxetine alone and fluoxetine + LY2216684||1.03|0.97|
73799722|NCT01243957|147147291|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|1.0|1.07|||ANOVA|||Ratio of Geometric LS Means of Cmax for norfluoxetine alone and norfluoxetine + LY2216684.||1.07|1.00|
73799723|NCT01243957|147147292|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.08||||0.423|TWO_SIDED|90.0|-3.0|1.42|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for fluoxetine alone and fluoxetine + LY2216684.||1.42|-3.00|0.4230
73799724|NCT01243957|147147292|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0||||0.0293|TWO_SIDED|90.0|-6.5|-1.0|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for norfluoxetine alone and norfluoxetine + LY2216684.||-1.00|-6.50|0.0293
73799725|NCT01402570|147147349|SUPERIORITY_OR_OTHER||REML|0.17||||0.66|TWO_SIDED|95.0|-0.67|0.95||Time was predictor of interest, controlling for age, gender, baseline PROMIS physical functioning, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.95|-0.67|0.66
73799726|NCT01402570|147147350|SUPERIORITY_OR_OTHER||REML|0.0||||0.44|TWO_SIDED|95.0|-0.01|0.02||Time was predictor of interest, controlling for age, gender, baseline sleep efficiency, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.02|-0.01|0.44
73799727|NCT01402570|147147351|SUPERIORITY_OR_OTHER||REML|145.54||||0.35|TWO_SIDED|95.0|-178.93|470.02||Time was predictor of interest, controlling for age, gender, baseline steps per day, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||470.02|-178.93|0.35
73799728|NCT01402570|147147352|SUPERIORITY_OR_OTHER||REML|-1.05||||0.07|TWO_SIDED|95.0|-2.21|0.1||Time was predictor of interest, controlling for age, gender, baseline fatigue, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.10|-2.21|0.07
73893327|NCT01247272|147319555|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.99|||||TWO_SIDED|90.0|102.09|112.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.12|102.09|
73893328|NCT01247272|147319556|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.57|||||TWO_SIDED|90.0|99.54|107.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.76|99.54|
73893329|NCT01247272|147319557|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||TWO_SIDED|90.0|101.66|110.12|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||110.12|101.66|
73893330|NCT01247272|147319558|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.83|||||TWO_SIDED|90.0|101.27|110.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||110.61|101.27|
73893331|NCT03530124|147319559|SUPERIORITY|The number of infants with ≥1 apneic event for each group and compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group (\< 28 weeks versus ≥ 28 weeks) to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea.|Odds Ratio (OR)|2.7||||0.0104|TWO_SIDED|95.0|1.27|5.73|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the primary objective.|||5.73|1.27|0.0104
73893332|NCT03530124|147319560|OTHER|The number of apnea events were compared using a linear regression model (assuming a Poisson distribution) with study site and gestational age group covariates to control for the randomization blocks.||||||0.11|||||||Regression, Linear|No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.||||||0.11
73893333|NCT03530124|147319561|OTHER|Average duration of apnea episodes between groups were compared using a mixed effects model with a random intercept for each infant with one or more events and study site and gestational age group as covariates to control for the randomization blocks.||||||0.36|||||||Mixed Effects Model|No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.||||||0.36
73893334|NCT03530124|147319562|SUPERIORITY|The proportion of infants requiring an increase in respiratory support for each group were compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea.|Odds Ratio (OR)|2.07||||0.3555|TWO_SIDED|95.0|0.59|7.23|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|||7.23|0.59|0.3555
73893335|NCT03530124|147319563|SUPERIORITY|The proportion of infants with ≥1 cardiorespiratory event using a Mantel-Haenszel statistic in at the two-sided alpha 0.05 level and corresponding 95% confidence interval.|Odds Ratio (OR)|0.89||||1|TWO_SIDED|95.0|0.29|2.77|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|Only Duke University had viable monitoring data to analyze this compound outcome objective.||2.77|0.29|1.0000
73893336|NCT03530124|147319564|SUPERIORITY||Odds Ratio (OR)|1.93||||1|TWO_SIDED|95.0|0.17|21.63|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|The proportion of infants requiring positive pressure ventilation for each group were compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea during the 48-hour monitoring period.||21.63|0.17|1.0000
73893337|NCT02093819|147319577|SUPERIORITY_OR_OTHER||Slope|1.1313|STANDARD_ERROR_OF_MEAN|0.0633|||TWO_SIDED|90.0|1.0249|1.2376|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.2376|1.0249|
73799729|NCT03514459|147147353|SUPERIORITY||Prevalence ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.54|2.2|||Poisson regression|Robust standard errors||||2.20|1.54|<0.001
73799730|NCT01321749|147147388|SUPERIORITY_OR_OTHER||||||<|0.05||5.0|||||Log Rank|||||||<0.05
73799731|NCT04179838|147147397|SUPERIORITY|||||||0.001||||||Corrected for multiple comparisons in piriform cortex|t-test, 1 sided|||Null hypothesis is that there was no difference in decoding accuracy between sleep-deprived and non-sleep deprived interventions. Paired t-test on decoding accuracy from both phases (sleep-deprived minus non-sleep deprived) against the null hypothesis of no difference.||||0.001
73799732|NCT04179838|147147398|SUPERIORITY|||||||0.021|||||||t-test, 1 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.021
73799733|NCT04179838|147147399|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.63
73799734|NCT04179838|147147400|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.08
73799735|NCT04179838|147147401|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.28
73799736|NCT04179838|147147402|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.50
73799737|NCT04179838|147147403|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.58
73799738|NCT02099786|147147423|SUPERIORITY||Odds Ratio (OR)|2.2||||0.27|TWO_SIDED|95.0|0.55|8.8|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with ASHA-significant threshold shifts between treatment arms.||8.8|.55|.27
73799739|NCT02099786|147147423|SUPERIORITY||Odds Ratio (OR)|1.4||||0.67|TWO_SIDED|95.0|0.3|5.9|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with CTCAE grade 1 or greater hearing loss between treatment arms.||5.9|.3|.67
73799740|NCT02099786|147147424|SUPERIORITY||Odds Ratio (OR)|0.92||||0.88|TWO_SIDED|95.0|0.29|2.9|||Regression, Logistic|||Null hypothesis is no difference in audiology clinic use between treatment arms.||2.9|.29|.88
73799741|NCT02099786|147147425|NON_INFERIORITY|We require a non-inferiority margin of no more than 1.1 mortality odds among COMP-VA patients relative to Usual Care patients. This means that the upper 95% confidence bound for the fitted odds ratio must be less than 1.1 to reject the null hypothesis that COMP-VA induces extra mortality risk.|Odds Ratio (OR)|1.9|||||ONE_SIDED|||||||||||||
73799742|NCT02099786|147147426|SUPERIORITY|||||||0.72||||||The a priori threshold for statistical significance is .05|t-test, 2 sided|||||||.72
73799743|NCT00080912|147147427|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The original sample size was determined based on the non-inferiority. The original sample size is based on assumption of response rate on the multiple fraction arm is 70%, 260 patients were required in each treatment arm to have 80% power to exclude, with a one sided alpha of 0.05, a response rate of 60% or less in the single fraction radiation group (non-inferiority margin =10%). Given an inevaluability rate of 30%, 850 patients (425 for each treatment arm) were randomized to the study.|Risk Difference (RD)|4.0||||0.03|ONE_SIDED|95.0||9.2||p-value is for one-sided non-inferiority test|Cochran-Mantel-Haenszel||The upper limit of one-sided 95% CI for the response rate difference was 9.2%, which was below the pre-specified 10% non-inferiority boundary|||9.2||0.03
73799744|NCT00818766|147147436|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.3||||0.26||95.0|-11.3|2.7|||Fisher Exact|||||2.7|-11.3|.26
73799745|NCT00818766|147147437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.93||||0.77|TWO_SIDED|95.0|-6.1|4.3|||Fisher Exact|||||4.3|-6.1|0.77
73799746|NCT00818766|147147438|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.4||||0.21|TWO_SIDED|95.0|-8.3|1.6|||Fisher Exact|||||1.6|-8.3|.21
73799747|NCT00818766|147147439|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||.49
73799748|NCT00818766|147147441|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|||||||.25
73799749|NCT00818766|147147442|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|||||||.25
73799750|NCT01111318|147147454|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.15|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|98.89|153.36|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy||153.36|98.89|
73799751|NCT01111318|147147454|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|146.97|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|118.02|183.02|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy||183.02|118.02|
73799752|NCT01111318|147147454|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|174.7|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|140.29|217.55|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy||217.55|140.29|
73799753|NCT01111318|147147455|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|103.81|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|82.29|130.95|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy||130.95|82.29|
73799754|NCT01111318|147147455|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.31|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|97.74|155.55|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy||155.55|97.74|
73799755|NCT01111318|147147455|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|148.41|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|117.65|187.23|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy||187.23|117.65|
73799756|NCT00725491|147147469|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Whitehead|||||||<0.001
73799757|NCT01999920|147147470|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||.064
73799758|NCT01999920|147147471|SUPERIORITY||Standard error|5.5|STANDARD_ERROR_OF_MEAN|3.13||0.11|TWO_SIDED|95.0|-1.32|12.32|||Mixed Models Analysis|||||12.32|-1.32|0.11
73799759|NCT01999920|147147472|SUPERIORITY||Standard error|0.34|STANDARD_ERROR_OF_MEAN|2.44||0.89|TWO_SIDED|95.0|-4.85|5.53|||Mixed Models Analysis|||Confidence variable||5.53|-4.85|0.89
73799760|NCT01999920|147147472|SUPERIORITY||Standard error|1.18|STANDARD_ERROR_OF_MEAN|4.41||0.79|TWO_SIDED|95.0|-8.21|10.58|||Mixed Models Analysis|||Discomfort with Closeness variable||10.58|-8.21|0.79
73799761|NCT01999920|147147472|SUPERIORITY||Standard error|3.94|STANDARD_ERROR_OF_MEAN|3.79||0.31|TWO_SIDED|95.0|-4.12|12.01|||Mixed Models Analysis|||Relationships as Secondary variable||12.01|-4.12|0.31
73799762|NCT01999920|147147472|SUPERIORITY||Standard error|-2.6|STANDARD_ERROR_OF_MEAN|1.49||0.1|TWO_SIDED|95.0|-5.79|0.58|||Mixed Models Analysis|||Need for Approval variable||0.58|-5.79|0.10
73799763|NCT01999920|147147472|SUPERIORITY||Standard error|0.71|STANDARD_ERROR_OF_MEAN|2.82||0.8|TWO_SIDED|95.0|-5.3|6.72|||Mixed Models Analysis|||Preoccupation with Relationships variable||6.72|-5.30|0.80
73799764|NCT01999920|147147473|SUPERIORITY||Standard error|-19.91|STANDARD_ERROR_OF_MEAN|6.99||0.008|TWO_SIDED|95.0|-34.23|-5.58|||Mixed Models Analysis|||||-5.58|-34.23|0.008
73799765|NCT01999920|147147474|SUPERIORITY||Standard error|3.29|STANDARD_ERROR_OF_MEAN|1.43||0.026|TWO_SIDED|95.0|0.42|6.16|||Mixed Models Analysis|||||6.16|0.42|0.026
73799766|NCT01999920|147147475|SUPERIORITY||Standard error|21.38|STANDARD_ERROR_OF_MEAN|7.65||0.01|TWO_SIDED|95.0|5.64|37.11|||Mixed Models Analysis|||||37.11|5.64|0.01
73799767|NCT03290378|147147517|SUPERIORITY||||||<|0.005|TWO_SIDED|95.0|||||ANCOVA|||||||<.005
73799768|NCT02015611|147147534|SUPERIORITY|||||||0.63|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.63
73799769|NCT02015611|147147535|SUPERIORITY|||||||0.64|||||||Regression, Linear|adjusted for age, sex, race, season, and baseline value||||||0.64
73799770|NCT02015611|147147536|SUPERIORITY|||||||0.08|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.08
73799771|NCT02015611|147147537|SUPERIORITY|||||||0.53|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.53
73799772|NCT02015611|147147538|SUPERIORITY|||||||0.75|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.75
73799773|NCT02015611|147147539|SUPERIORITY|||||||0.92|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.92
73799774|NCT02015611|147147540|SUPERIORITY|||||||0.94|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.94
73799775|NCT02015611|147147541|SUPERIORITY|||||||0.61|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.61
73799776|NCT02015611|147147542|SUPERIORITY|||||||0.59|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.59
73799777|NCT02015611|147147543|SUPERIORITY|||||||0.21|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.21
73799778|NCT03787134|147147614|SUPERIORITY|||||||0.335|||||||t-test, 2 sided|||cued memory item reconstruction - test of reconstruction strength against 0||||.335
73799779|NCT03787134|147147614|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||uncued memory item reconstruction - test of reconstruction strength against 0||||.016
73799780|NCT03281876|147147630|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group. The objective is to be considered a success if the lower limit of the 87% CI is above 0%.|Other: Vaccine Efficacy rate|-2.26||||0.8157|TWO_SIDED|87.0|-18.27|11.58|||Negative Binomial regression|Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs||11.58|-18.27|0.8157
73799781|NCT03281876|147147631|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group.|Other: Vaccine Efficacy rate|-2.26||||0.8157|TWO_SIDED|95.0|-23.45|15.29|||Negative Binomial regression|Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs||15.29|-23.45|0.8157
73799782|NCT03281876|147147638|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the control group.|Vaccine efficacy rate|-2.72||||0.77|TWO_SIDED|95.0|-22.95|14.19|||Negative Binomial regression|||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of AECOPDs of any severity- upto 12 months follow up period||14.19|-22.95|0.7700
73799783|NCT03281876|147147640|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.94||||0.5751|TWO_SIDED|95.0|0.758|1.166|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate or severe AECOPDs, one year follow-up starting 1 month post dose 2||1.166|0.758|0.5751
73799784|NCT03281876|147147641|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.934||||0.5194|TWO_SIDED|95.0|0.758|1.15|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for any AECOPDs, one year follow-up starting 1 month post dose 2||1.15|0.758|0.5194
73799785|NCT03281876|147147642|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.05||||0.8581|TWO_SIDED|95.0|0.616|1.791|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for mild AECOPDs, one year follow-up starting 1 month post dose 2||1.791|0.616|0.8581
73799786|NCT03281876|147147642|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.995||||0.9634|TWO_SIDED|95.0|0.792|1.249|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate AECOPDs, one year follow-up starting 1 month post dose 2||1.249|0.792|0.9634
73799787|NCT03281876|147147642|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.722||||0.1755|TWO_SIDED|95.0|0.45|1.157|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for severe AECOPDs, one year follow-up starting 1 month post dose 2||1.157|0.45|0.1755
73799788|NCT03281876|147147649|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.038||||0.9463|TWO_SIDED|95.0|0.73|1.477|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate or severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.477|0.73|0.9463
73799789|NCT03281876|147147650|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.093||||0.6042|TWO_SIDED|95.0|0.782|1.528|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for any NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.528|0.782|0.6042
73799790|NCT03281876|147147651|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|2.243||||0.0777|TWO_SIDED|95.0|0.914|5.504|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for mild NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||5.504|0.914|0.0777
73799791|NCT03281876|147147651|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.021||||0.9121|TWO_SIDED|95.0|0.71|1.467|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.467|0.71|0.9121
73799792|NCT03281876|147147651|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.12||||0.8737|TWO_SIDED|95.0|0.278|4.502|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||4.502|0.278|0.8737
73799793|NCT02208089|147147663|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Null hypothesis = TransPRK produced no gains in vision over and above those produced by CXL only||||0.03
73799794|NCT02208089|147147664|SUPERIORITY|||||||0.005|||||||Chi-squared|||Null hypothesis = an equal proportion of patients in both study arms have clinically significant visual gains||||0.005
73799795|NCT02208089|147147665|NON_INFERIORITY|Non-inferiority = no significant difference between rates of clinically significant visual loss between groups at the p≤0.05 level||||||0.13|||||||Chi-squared|||null hypothesis = rates of clinically significant visual loss are equal for TransPRKCXL and CXL only||||0.13
73799796|NCT00683657|147147671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.16||0.0001|TWO_SIDED|95.0|-25.1|-8.5||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pre treatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin.|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-8.5|-25.1|0.0001
73799797|NCT00683657|147147672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-44.4|-16.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-16.1|-44.4|<0.0001
73799798|NCT00683657|147147673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.4|STANDARD_ERROR_OF_MEAN|10.41||0.001|TWO_SIDED|95.0|-56.2|-14.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-14.7|-56.2|0.0010
73799799|NCT00683657|147147674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|STANDARD_ERROR_OF_MEAN|4.22|<|0.0001|TWO_SIDED|95.0|-27.1|-10.3||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-10.3|-27.1|<0.0001
73893338|NCT02093819|147319577|SUPERIORITY_OR_OTHER||Slope|0.9568|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|90.0|0.783|1.1307|||||Evaluation of dose proportionality - dose groups 50mg to 600mg. Number of subjects included in the analysis=28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1307|0.7830|
73799800|NCT00683657|147147675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|4.0||0.0002|TWO_SIDED|95.0|-23.3|-7.4||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-7.4|-23.3|0.0002
73799801|NCT00972595|147147706|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.98||||||90.0|0.93|1.03||||||Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||1.03|0.93|
73799802|NCT00972595|147147707|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.99||||||90.0|0.93|1.05||||||"Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom~(U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the~United Kingdom (U.K.) taken orally"||1.05|0.93|
73799803|NCT02586155|147147770|SUPERIORITY||Cox Proportional Hazard|0.823||||0.107|TWO_SIDED|95.0|0.649|1.044|||Stratified long-rank|||||1.044|0.649|0.1070
73799804|NCT02586155|147147771|SUPERIORITY||Cox Proportional Hazard|0.849||||0.1495|TWO_SIDED|95.0|0.679|1.061|||Stratified long-rank|||||1.061|0.679|0.1495
73799805|NCT02586155|147147772|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.03|TWO_SIDED|95.0|0.38|0.94|||Stratified long-rank|||||0.94|0.38|0.03
73799806|NCT02586155|147147773|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.44|TWO_SIDED|95.0|0.62|1.24|||Stratified long-rank|||||1.24|0.62|0.44
73799807|NCT02586155|147147784|SUPERIORITY||Cox Proportional Hazard|0.78||||0.03|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.03
73799808|NCT02085447|147147785|SUPERIORITY|||||||0.012|||||||t-test, 1 sided|||||||.012
73799809|NCT02085447|147147786|SUPERIORITY|||||||0.028|||||||t-test, 1 sided|||||||.028
73799810|NCT02085447|147147787|SUPERIORITY|||||||0.162|||||||t-test, 1 sided|||||||.162
73799811|NCT02085447|147147788|SUPERIORITY|||||||0.021|||||||t-test, 1 sided|||||||.021
73799812|NCT02085447|147147789|SUPERIORITY|||||||0.005|||||||t-test, 1 sided|||||||.005
73799813|NCT02085447|147147790|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
73799814|NCT02085447|147147791|SUPERIORITY|||||||0.197|||||||t-test, 1 sided|||||||.197
73799815|NCT02085447|147147792|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
73799816|NCT02085447|147147793|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
73799817|NCT02085447|147147794|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
73799818|NCT02085447|147147795|SUPERIORITY|||||||0.053|||||||t-test, 1 sided|||||||.053
73799819|NCT02085447|147147796|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
73799820|NCT02085447|147147797|SUPERIORITY|||||||0.821|||||||t-test, 1 sided|||||||.821
73799821|NCT02085447|147147798|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.330
73799822|NCT02085447|147147799|SUPERIORITY|||||||0.425|||||||t-test, 1 sided|||||||.425
73799823|NCT02085447|147147800|SUPERIORITY|||||||0.577|||||||t-test, 1 sided|||||||.577
73799824|NCT02085447|147147801|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.330
73799825|NCT02085447|147147802|SUPERIORITY|||||||0.706|||||||t-test, 1 sided|||||||.706
73799826|NCT02085447|147147803|SUPERIORITY|||||||0.481|||||||t-test, 1 sided|||||||.481
73799827|NCT02085447|147147804|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||.020
73799828|NCT02085447|147147805|SUPERIORITY|||||||0.103|||||||t-test, 1 sided|||||||.103
73799829|NCT02085447|147147806|SUPERIORITY|||||||0.063|||||||t-test, 1 sided|||||||.063
73799830|NCT04779879|147147815|OTHER||Ratio of geometric least squares mean|1.04|||||TWO_SIDED|90.0|0.98|1.09|||||Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.09|0.98|
73799831|NCT04779879|147147816|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.94|1.11|||||Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.11|0.94|
73799832|NCT04779879|147147845|OTHER||Ratio of geometric least squares mean|1.05|||||TWO_SIDED|90.0|1.0|1.11|||||Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.11|1.00|
73799833|NCT04779879|147147846|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.07|0.97|
73799834|NCT04779879|147147847|OTHER||Ratio of geometric least squares mean|1.01|||||TWO_SIDED|90.0|0.93|1.09|||||Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.09|0.93|
73799835|NCT04779879|147147848|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.94|1.1|||||Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.10|0.94|
73799836|NCT04779879|147147909|OTHER||Ratio of geometric least squares mean|0.66|||||TWO_SIDED|90.0|0.48|0.89|||||Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.|||0.89|0.48|
73893339|NCT02093819|147319578|SUPERIORITY_OR_OTHER||Slope|1.0732|STANDARD_ERROR_OF_MEAN|0.0468|||TWO_SIDED|90.0|0.9946|1.1518|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1518|0.9946|
73893340|NCT02093819|147319578|SUPERIORITY_OR_OTHER||Slope|0.9603|STANDARD_ERROR_OF_MEAN|0.0838|||TWO_SIDED|90.0|0.8174|1.1032|||||Evaluation of dose proportionality - dose groups 50 mg to 600 mg. Number of subjects included in the analysis 28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1032|0.8174|
73893341|NCT02447302|147319581|SUPERIORITY||Difference in least square mean|-0.99|STANDARD_ERROR_OF_MEAN|0.42|=|0.0091|TWO_SIDED|90.0|-1.68|-0.3||The analysis was performed using an analysis of covariance (ANCOVA) model that incorporated treatment, current oral corticosteroid use, prior exposure to tumor necrosis factor alpha (TNFα) antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.30|-1.68|= 0.0091
73893342|NCT02447302|147319581|SUPERIORITY||Difference in least square mean|-0.43|STANDARD_ERROR_OF_MEAN|0.41|=|0.1457|TWO_SIDED|90.0|-1.11|0.24||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.24|-1.11|= 0.1457
73893343|NCT02447302|147319582|SUPERIORITY||MH estimate for difference in percentage|24.4|STANDARD_ERROR_OF_MEAN|8.87|=|0.003|TWO_SIDED|90.0|9.8|39.0||Mantel-Haenszel (MH) estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||39.0|9.8|= 0.003
73893344|NCT02447302|147319582|SUPERIORITY||MH estimate for difference in percentage|4.1|STANDARD_ERROR_OF_MEAN|7.98|=|0.3059|TWO_SIDED|90.0|-9.1|17.2||MH estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||17.2|-9.1|= 0.3059
73893345|NCT02447302|147319583|SUPERIORITY||Difference in least square mean|-0.84|STANDARD_ERROR_OF_MEAN|0.29|=|0.002|TWO_SIDED|90.0|-1.32|-0.36||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.36|-1.32|= 0.0020
73799837|NCT04779879|147147909|OTHER||Ratio of geometric least squares mean|0.58|||||TWO_SIDED|90.0|0.43|0.79|||||Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.|||0.79|0.43|
73893346|NCT02447302|147319583|SUPERIORITY||Difference in least square mean|-0.39|STANDARD_ERROR_OF_MEAN|0.28|=|0.0858|TWO_SIDED|90.0|-0.85|0.08||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.08|-0.85|= 0.0858
73893347|NCT02447302|147319584|SUPERIORITY||Difference in least square mean|-1.27|STANDARD_ERROR_OF_MEAN|0.55|=|0.01|TWO_SIDED|90.0|-2.17|-0.37||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.37|-2.17|= 0.0100
73799838|NCT04779879|147147910|OTHER||Ratio of geometric least squares mean|1.14|||||TWO_SIDED|90.0|0.67|1.95|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.95|0.67|
73799839|NCT04779879|147147911|OTHER||Ratio of geometric least squares mean|1.06|||||TWO_SIDED|90.0|0.69|1.62|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.62|0.69|
73799840|NCT04779879|147147912|OTHER||Ratio of geometric least squares mean|1.11|||||TWO_SIDED|90.0|0.68|1.82|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.82|0.68|
73799841|NCT04779879|147147913|OTHER||Ratio of geometric least squares mean|1.28|||||TWO_SIDED|90.0|0.77|2.12|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||2.12|0.77|
73893348|NCT02447302|147319584|SUPERIORITY||Difference in least square mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53|=|0.1277|TWO_SIDED|90.0|-1.48|0.27||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.27|-1.48|= 0.1277
73893349|NCT02447302|147319585|SUPERIORITY||Odds Ratio (OR)|2.78|||=|0.0071|TWO_SIDED|90.0|1.4|5.51||The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.|ANCOVA|The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.||The primary comparison in the study was between etrasimod 2 mg versus placebo.||5.51|1.40|= 0.0071
73893350|NCT02447302|147319585|SUPERIORITY||Odds Ratio (OR)|1.61|||=|0.1192|TWO_SIDED|90.0|0.83|3.14||The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.|ANCOVA|The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.||||3.14|0.83|= 0.1192
73893351|NCT02447302|147319586|SUPERIORITY||MH estimate for difference in percentage|25.8|STANDARD_ERROR_OF_MEAN|7.47|=|0.0003|TWO_SIDED|90.0|13.5|38.1||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||38.1|13.5|= 0.0003
73893352|NCT02447302|147319586|SUPERIORITY||MH estimate for difference in percentage|7.1|STANDARD_ERROR_OF_MEAN|6.46|=|0.136|TWO_SIDED|90.0|-3.5|17.7||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||17.7|-3.5|= 0.1360
73893353|NCT02447302|147319587|SUPERIORITY||MH estimate for difference in percentage|18.9|STANDARD_ERROR_OF_MEAN|9.92|=|0.0282|TWO_SIDED|90.0|2.6|35.3||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||35.3|2.6|= 0.0282
73893354|NCT02447302|147319587|SUPERIORITY||MH estimate for difference in percentage|11.4|STANDARD_ERROR_OF_MEAN|10.14|=|0.1309|TWO_SIDED|90.0|-5.3|28.1||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||28.1|-5.3|= 0.1309
73893355|NCT01901250|147319588|SUPERIORITY_OR_OTHER|||||||0.25|||||||Permutation test|Adjusted for child's gender, caries burden at study entry, surface-years at risk, and study cohort.||||||0.25
73893356|NCT01400880|147319601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|STANDARD_DEVIATION|3.28|||TWO_SIDED|95.0|1.7|4.27||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for TOCO and IUPC. Agreement between TOCO and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.||4.27|1.70|
73893357|NCT01400880|147319601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_DEVIATION|2.65|||TWO_SIDED|95.0|2.98|4.92||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for the electrode sensor and IUPC. Agreement between electrode sensor and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.||4.92|2.98|
73893358|NCT02445794|147319633|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||.008
73893359|NCT02785770|147319693|SUPERIORITY_OR_OTHER||LS mean difference|0.96||||0.454|TWO_SIDED|90.0|-1.15|3.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.07|-1.15|0.4540
73893360|NCT02785770|147319693|SUPERIORITY_OR_OTHER||LS mean difference|7.88|||<|0.0001|TWO_SIDED|90.0|5.77|9.99|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||9.99|5.77|< 0.0001
73893361|NCT02785770|147319693|SUPERIORITY_OR_OTHER||LS mean difference|11.33|||<|0.0001|TWO_SIDED|90.0|9.22|13.44|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||13.44|9.22|< 0.0001
73893362|NCT02785770|147319693|SUPERIORITY_OR_OTHER||LS mean difference|8.59|||<|0.0001|TWO_SIDED|90.0|6.48|10.7|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||10.70|6.48|< 0.0001
73893363|NCT02785770|147319693|SUPERIORITY_OR_OTHER||LS mean difference|8.96|||<|0.0001|TWO_SIDED|90.0|6.85|11.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||11.07|6.85|< 0.0001
73893364|NCT02785770|147319693|SUPERIORITY_OR_OTHER||LS mean difference|8.07|||<|0.0001|TWO_SIDED|90.0|5.96|10.18|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||10.18|5.96|< 0.0001
73893365|NCT02785770|147319693|SUPERIORITY_OR_OTHER||LS mean difference|5.53|||<|0.0001|TWO_SIDED|90.0|3.42|7.64|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.64|3.42|< 0.0001
73893366|NCT02785770|147319693|SUPERIORITY_OR_OTHER||LS mean difference|3.74||||0.0036|TWO_SIDED|90.0|1.64|5.85|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.85|1.64|0.0036
73893367|NCT02785770|147319694|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.29||||0.8195|TWO_SIDED|90.0|-2.38|1.8|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.80|-2.38|0.8195
73893368|NCT02785770|147319694|SUPERIORITY_OR_OTHER||LS Mean Difference|4.54||||0.0004|TWO_SIDED|90.0|2.44|6.64|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||6.64|2.44|0.0004
73893369|NCT02785770|147319695|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.9146|TWO_SIDED|90.0|-1.95|2.22|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.22|-1.95|0.9146
73893370|NCT02785770|147319695|SUPERIORITY_OR_OTHER||LS mean difference|5.04|||<|0.0001|TWO_SIDED|90.0|2.95|7.14|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.14|2.95|<0.0001
73893371|NCT02785770|147319696|SUPERIORITY_OR_OTHER||LS mean difference|1.24||||0.3272|TWO_SIDED|90.0|-0.84|3.33|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.33|-0.84|0.3272
73893372|NCT02785770|147319696|SUPERIORITY_OR_OTHER||LS mean difference|4.26||||0.0009|TWO_SIDED|90.0|2.16|6.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||6.36|2.16|0.0009
73893373|NCT02785770|147319697|SUPERIORITY_OR_OTHER||LS mean difference|-0.48||||0.7024|TWO_SIDED|90.0|-2.57|1.6|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.60|-2.57|0.7024
73893374|NCT02785770|147319697|SUPERIORITY_OR_OTHER||LS mean difference|2.26||||0.0768|TWO_SIDED|90.0|0.16|4.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.36|0.16|0.0768
73799842|NCT02854527|147147971|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|96.39|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|88.22|105.33|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R1.||105.33|88.22|
73799843|NCT02854527|147147972|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|93.17|STANDARD_DEVIATION|24.1|||TWO_SIDED|90.0|83.49|103.97|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R1.||103.97|83.49|
73799844|NCT02854527|147147973|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|102.62|STANDARD_DEVIATION|20.4|||TWO_SIDED|90.0|93.82|112.25|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R2.||112.25|93.82|
73893375|NCT02785770|147319698|SUPERIORITY_OR_OTHER||LS mean difference|-1.97||||0.1201|TWO_SIDED|90.0|-4.06|0.12|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.12|-4.06|0.1201
73893376|NCT02785770|147319698|SUPERIORITY_OR_OTHER||LS mean difference|1.21||||0.3424|TWO_SIDED|90.0|-0.89|3.31|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.31|-0.89|0.3424
73893377|NCT02785770|147319699|SUPERIORITY_OR_OTHER||LS mean difference|-1.35||||0.287|TWO_SIDED|90.0|-3.44|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.74|-3.44|0.2870
73893378|NCT02785770|147319699|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.9334|TWO_SIDED|90.0|-2.21|1.99|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.99|-2.21|0.9334
73893379|NCT02785770|147319700|SUPERIORITY_OR_OTHER||LS mean difference|-2.16||||0.0893|TWO_SIDED|90.0|-4.24|-0.07|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.07|-4.24|0.0893
73893380|NCT02785770|147319700|SUPERIORITY_OR_OTHER||LS mean difference|-2.61||||0.0412|TWO_SIDED|90.0|-4.71|-0.51|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.51|-4.71|0.0412
73893381|NCT02785770|147319701|SUPERIORITY_OR_OTHER||LS mean difference|-1.34||||0.2892|TWO_SIDED|90.0|-3.43|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.74|-3.43|0.2892
73893382|NCT02785770|147319701|SUPERIORITY_OR_OTHER||LS mean difference|-2.78||||0.0294|TWO_SIDED|90.0|-4.88|-0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.68|-4.88|0.0294
73893383|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|1.28||||0.16|TWO_SIDED|90.0|-0.22|2.78|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.78|-0.22|0.1600
73893384|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|2.38||||0.0092|TWO_SIDED|90.0|0.88|3.87|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.87|0.88|0.0092
73893385|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|0.91||||0.3174|TWO_SIDED|90.0|-0.59|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.41|-0.59|0.3174
73893386|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|-0.31||||0.7344|TWO_SIDED|90.0|-1.81|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.19|-1.81|0.7344
73893387|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.5881|TWO_SIDED|90.0|-1.0|1.99|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.99|-1.00|0.5881
73893388|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|-0.82||||0.368|TWO_SIDED|90.0|-2.32|0.68|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.68|-2.32|0.3680
73799845|NCT02854527|147147974|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|103.96|STANDARD_DEVIATION|24.0|||TWO_SIDED|90.0|93.6|115.46|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R2.||115.46|93.60|
73893389|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|-0.73||||0.42|TWO_SIDED|90.0|-2.23|0.76|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.76|-2.23|0.4200
73893390|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|-3.03||||0.0009|TWO_SIDED|90.0|-4.53|-1.53|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-1.53|-4.53|0.0009
73893391|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|4.46|||<|0.0001|TWO_SIDED|90.0|2.96|5.97|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.97|2.96|< 0.0001
73893392|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|5.83|||<|0.0001|TWO_SIDED|90.0|4.32|7.33|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.33|4.32|< 0.0001
73893393|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|4.09|||<|0.0001|TWO_SIDED|90.0|2.58|5.59|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.59|2.58|< 0.0001
73893394|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|2.53||||0.0059|TWO_SIDED|90.0|1.02|4.03|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.03|1.02|0.0059
73893395|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|2.5||||0.0063|TWO_SIDED|90.0|1.0|4.01|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.01|1.00|0.0063
73893396|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|1.45||||0.1138|TWO_SIDED|90.0|-0.06|2.95|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.95|-0.06|0.1138
73799846|NCT02854527|147147975|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|97.49|STANDARD_DEVIATION|9.0|||TWO_SIDED|90.0|93.54|101.61|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R3.||101.61|93.54|
73799847|NCT02854527|147147976|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|98.25|STANDARD_DEVIATION|14.7|||TWO_SIDED|90.0|91.85|105.09|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R3.||105.09|91.85|
73799848|NCT02854527|147147977|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|105.01|STANDARD_DEVIATION|18.8|||TWO_SIDED|90.0|96.39|114.4|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R4.||114.40|96.39|
73799849|NCT02854527|147147978|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|104.28|STANDARD_DEVIATION|20.6|||TWO_SIDED|90.0|94.95|114.53|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R4.||114.53|94.95|
73799850|NCT02854527|147147979|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|96.53|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|92.08|101.2|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R1.||101.20|92.08|
73799851|NCT02854527|147147980|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|97.4|STANDARD_DEVIATION|9.6|||TWO_SIDED|90.0|90.87|104.41|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R2.||104.41|90.87|
73799852|NCT02854527|147147981|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|97.5|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|93.58|101.58|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R3.||101.58|93.58|
73799853|NCT02854527|147147982|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|107.63|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|97.04|119.39|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R4.||119.39|97.04|
73799854|NCT02899962|147147983|SUPERIORITY|The primary endpoint was time to first relapse during the maintenance phase. This was calculated as the number of days from randomisation to the day where the subject had the first relapse confirmed. For subjects who either did not encounter a relapse or were withdrawn from the trial, the number of days was treated as a censored observation at the day of end of trial visit.|Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.47|0.69|||Regression, Cox||Estimates are obtained from a proportional hazards model with treatment group,pooled trial site,disease severity at maintenance baseline (Week 4; determined by PGA) as factors.|All randomized subjects were considered for statistical analysis.||0.69|0.47|<0.001
73799855|NCT02899962|147147984|SUPERIORITY||Mean Difference (Net)|0.11|||<|0.001|TWO_SIDED|95.0|0.08|0.14|||ANOVA|Factors adjusted for in the ANOVA model were treatment group, pooled trial site, and disease severity at maintenance baseline (PGA).|Multiple imputation of data for withdrawn subjects was done using 100 imputations and depended on whether the subject's reason for withdrawal potentially was related to treatment. Length of the maintenance phase was assumed to be 52 weeks (364 days)|The number of days in remission was calculated as the sum of days where the subject was in remission periods. The proportion of days in remission was calculated as the number of days in remission divided by the length of the maintenance phase in days.||0.14|0.08|<0.001
73799856|NCT02899962|147147985|SUPERIORITY||Rate ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.46|0.63|||Poisson regression||The number of relapses was analysed using a Poisson regression model with treatment group,pooled sites,disease severity at maintenance baseline as factors, subject as random effect, and time at risk as an offset.|||0.63|0.46|<0.001
73893397|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|-0.36||||0.6976|TWO_SIDED|90.0|-1.86|1.15|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.15|-1.86|0.6976
73893398|NCT02785770|147319702|SUPERIORITY_OR_OTHER||LS mean difference|-2.12||||0.0208|TWO_SIDED|90.0|-3.62|-0.61|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.61|-3.62|0.0208
73893399|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-0.64||||0.576|TWO_SIDED|90.0|-2.53|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.25|-2.53|0.5760
73893400|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-0.94||||0.4126|TWO_SIDED|90.0|-2.83|0.95|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.95|-2.83|0.4126
73893401|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-1.17||||0.3085|TWO_SIDED|90.0|-3.06|0.72|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.72|-3.06|0.3085
73893402|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-0.99||||0.3889|TWO_SIDED|90.0|-2.88|0.9|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.90|-2.88|0.3889
73893403|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-0.57||||0.6192|TWO_SIDED|90.0|-2.46|1.32|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.32|-2.46|0.6192
73893404|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-2.45||||0.0332|TWO_SIDED|90.0|-4.34|-0.56|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.56|-4.34|0.0332
73893405|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-0.41||||0.7224|TWO_SIDED|90.0|-2.3|1.48|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.48|-2.30|0.7224
73893406|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|0.52||||0.6507|TWO_SIDED|90.0|-1.37|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.41|-1.37|0.6507
73799857|NCT00550459|147147995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_DEVIATION|0.55||0.08|TWO_SIDED|95.0|-0.03|0.5||Secondary endpoints were ordered in 5 tiers to be analyzed only when \>=1 of the endpoints in the prior tier were significant. Since primary endpoint not stat significant, analyses of secondary endpoint tiers presented for exploratory purposes only|ANCOVA|ANCOVA with factors of treatment, disease severity, age(6 Degrees of Freedom), and covariate baseline to fit primary endpoint using the ITT dataset.||Analysis of covariance (ANCOVA) with factors of treatment,disease severity (\<130mEq/L \[mmol/L\] or ≥130mEq/L \[mmol/L\] at baseline),age (\<65, ≥65 to \<75,and ≥75 years) (factor with 6 Degrees of Freedom), and covariate baseline used to fit primary endpoint using the intent-to-treat (ITT) dataset. Estimated treatment effect and its 95% confidence interval (CI) provided under the model with p-value. A 2-sided alpha (0.05) applied to the primary analysis. Primary analysis based on observed cases (OC).||0.50|-0.03|0.08
73893407|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-1.72||||0.1366|TWO_SIDED|90.0|-3.62|0.18|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.18|-3.62|0.1366
73799858|NCT00550459|147147996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.63||0.21|TWO_SIDED|95.0|-0.12|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.51|-0.12|0.21
73893408|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-2.81||||0.0153|TWO_SIDED|90.0|-4.71|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.91|-4.71|0.0153
73893409|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-1.88||||0.104|TWO_SIDED|90.0|-3.78|0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.02|-3.78|0.1040
73893410|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-1.51||||0.1924|TWO_SIDED|90.0|-3.41|0.4|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.40|-3.41|0.1924
73893411|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-1.94||||0.0928|TWO_SIDED|90.0|-3.84|-0.04|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.04|-3.84|0.0928
73799859|NCT00550459|147147997|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.27|STANDARD_DEVIATION|0.41||0.02|TWO_SIDED|95.0|0.04|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.51|0.04|0.02
73799860|NCT00550459|147147998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26|STANDARD_DEVIATION|0.83||0.21|TWO_SIDED|95.0|-0.15|0.67||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.67|-0.15|0.21
73799861|NCT00550459|147147999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_DEVIATION|0.39||0.16|TWO_SIDED|95.0|-0.05|0.3||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.30|-0.05|0.16
73799862|NCT00550459|147148000|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.51|STANDARD_DEVIATION|3.53||0.23|TWO_SIDED|95.0|-4.02|1.0||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||1.00|-4.02|0.23
73799863|NCT00550459|147148001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_DEVIATION|3.51||0.18|TWO_SIDED|95.0|-2.04|0.38||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.38|-2.04|0.18
73799864|NCT00550459|147148002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.75|STANDARD_DEVIATION|3.45|<|0.0001|TWO_SIDED|95.0|2.89|6.6||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||6.60|2.89|<0.0001
73893412|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-2.06||||0.0745|TWO_SIDED|90.0|-3.96|-0.16|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.16|-3.96|0.0745
73893413|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-1.01||||0.3836|TWO_SIDED|90.0|-2.91|0.9|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.90|-2.91|0.3836
73893414|NCT02785770|147319703|SUPERIORITY_OR_OTHER||LS mean difference|-2.07||||0.0734|TWO_SIDED|90.0|-3.97|-0.17|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.17|-3.97|0.0734
73893415|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|0.8||||0.2588|TWO_SIDED|90.0|-0.36|1.96|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.96|-0.36|0.2588
73893416|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.8465|TWO_SIDED|90.0|-1.03|1.3|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.30|-1.03|0.8465
73893417|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|1.02||||0.1502|TWO_SIDED|90.0|-0.15|2.18|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.18|-0.15|0.1502
73799865|NCT02456740|147148028|SUPERIORITY|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.88|-0.92|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.92|-1.88|< 0.001
73893418|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.97|TWO_SIDED|90.0|-1.19|1.14|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.14|-1.19|0.9700
73799866|NCT02456740|147148028|SUPERIORITY|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.33|-1.37|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.37|-2.33|< 0.001
73799867|NCT02456740|147148029|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.52|2.98|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).||2.98|1.52|< 0.001
73893419|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|-1.18||||0.0947|TWO_SIDED|90.0|-2.34|-0.02|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.02|-2.34|0.0947
73893420|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.7759|TWO_SIDED|90.0|-0.96|1.36|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.36|-0.96|0.7759
73893421|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.9649|TWO_SIDED|90.0|-1.13|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.19|-1.13|0.9649
73893422|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.9034|TWO_SIDED|90.0|-1.08|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.25|-1.08|0.9034
73893423|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|-0.68||||0.3391|TWO_SIDED|90.0|-1.85|0.49|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.49|-1.85|0.3391
73893424|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|-1.19||||0.0948|TWO_SIDED|90.0|-2.35|-0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.02|-2.35|0.0948
73893425|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|-0.74||||0.2959|TWO_SIDED|90.0|-1.91|0.43|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.43|-1.91|0.2959
73799868|NCT02456740|147148029|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|Odds Ratio (OR)|2.81|||<|0.001|TWO_SIDED|95.0|2.01|3.94|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).||3.94|2.01|< 0.001
73893426|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.9161|TWO_SIDED|90.0|-1.24|1.09|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.09|-1.24|0.9161
73893427|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|-2.07||||0.0036|TWO_SIDED|90.0|-3.24|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.91|-3.24|0.0036
73893428|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|-0.73||||0.3063|TWO_SIDED|90.0|-1.89|0.44|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.44|-1.89|0.3063
73893429|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.4918|TWO_SIDED|90.0|-1.65|0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.68|-1.65|0.4918
73893430|NCT02785770|147319704|SUPERIORITY_OR_OTHER||LS mean difference|-0.61||||0.3862|TWO_SIDED|90.0|-1.78|0.55|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.55|-1.78|0.3862
73893431|NCT04518995|147319713|SUPERIORITY||Risk Difference (RD)|0.28|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.23|0.33||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.33|0.23|<0.0001
73893432|NCT04518995|147319713|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.32|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.46|0.32|<0.0001
73893433|NCT04518995|147319714|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.17|0.32||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.32|0.17|<0.0001
73893434|NCT04518995|147319714|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.26|0.43||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.43|0.26|<0.0001
73893435|NCT04518995|147319714|SUPERIORITY||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.24|0.38||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.38|0.24|<0.0001
73893436|NCT04518995|147319714|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.35|0.51||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.51|0.35|<0.0001
73893437|NCT04518995|147319714|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.26|0.39||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.39|0.26|<0.0001
73893438|NCT04518995|147319714|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.39|0.55||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.55|0.39|<0.0001
73893439|NCT04518995|147319714|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.31|0.44||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.44|0.31|<0.0001
73893440|NCT04518995|147319714|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.39|0.55||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.55|0.39|<0.0001
73893441|NCT04518995|147319715|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.0816|TWO_SIDED|95.0|0.0|0.02||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 4||0.02|-0.00|0.0816
73893442|NCT04518995|147319715|SUPERIORITY||Risk Difference (RD)|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.0005|TWO_SIDED|95.0|0.01|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|0.01|0.0005
73893443|NCT04518995|147319715|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.016||0.0002|TWO_SIDED|95.0|0.03|0.09||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.09|0.03|0.0002
73893444|NCT04518995|147319715|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.14|0.06|<0.0001
73893445|NCT04518995|147319715|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.12|0.22||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.22|0.12|<0.0001
73893446|NCT04518995|147319715|SUPERIORITY||Risk Difference (RD)|0.14|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.19||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.19|0.10|<0.0001
73799869|NCT02456740|147148030|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|LS Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.23|-0.64|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.64|-1.23|< 0.001
73799870|NCT02456740|147148030|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|LS Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.71|-1.12|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, (stratification factors region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.12|-1.71|< 0.001
73893447|NCT04518995|147319715|SUPERIORITY||Risk Difference (RD)|0.27|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.2|0.33||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.33|0.20|<0.0001
73893448|NCT04518995|147319715|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.19|0.28||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.28|0.19|<0.0001
73893449|NCT04518995|147319715|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.28|0.41||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.41|0.28|<0.0001
73893450|NCT04518995|147319716|SUPERIORITY||Least Square (LS) Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.13||0.0564|TWO_SIDED|95.0|-4.4|0.1||P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||0.1|-4.4|0.0564
73893451|NCT04518995|147319716|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.23||0.0054|TWO_SIDED|95.0|-5.9|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-1.0|-5.9|0.0054
73893452|NCT04518995|147319716|SUPERIORITY||LS Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|2.16|<|0.0001|TWO_SIDED|95.0|-12.7|-4.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-4.3|-12.7|<0.0001
73893453|NCT04518995|147319716|SUPERIORITY||LS Mean Difference|-14.9|STANDARD_ERROR_OF_MEAN|2.34|<|0.0001|TWO_SIDED|95.0|-19.5|-10.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-10.3|-19.5|<0.0001
73893454|NCT04518995|147319716|SUPERIORITY||LS Mean Difference|-21.7|STANDARD_ERROR_OF_MEAN|2.94|<|0.0001|TWO_SIDED|95.0|-27.5|-16.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-16.0|-27.5|<0.0001
73893455|NCT04518995|147319716|SUPERIORITY||LS Mean Difference|-30.0|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-36.3|-23.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-23.8|-36.3|<0.0001
73893456|NCT04518995|147319716|SUPERIORITY||LS Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|3.38|<|0.0001|TWO_SIDED|95.0|-35.1|-21.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-21.8|-35.1|<0.0001
73893457|NCT04518995|147319716|SUPERIORITY||LS Mean Difference|-38.5|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-45.7|-31.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-31.3|-45.7|<0.0001
73799871|NCT02456740|147148031|SUPERIORITY|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.43|||<|0.001|TWO_SIDED|95.0|-3.51|-1.35|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.35|-3.51|< 0.001
73893458|NCT04518995|147319716|SUPERIORITY||LS Mean Difference|-34.9|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-42.1|-27.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-27.7|-42.1|<0.0001
73893459|NCT04518995|147319716|SUPERIORITY||LS Mean Difference|-44.6|STANDARD_ERROR_OF_MEAN|3.96|<|0.0001|TWO_SIDED|95.0|-52.3|-36.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-36.8|-52.3|<0.0001
73893460|NCT04518995|147319716|SUPERIORITY||LS Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|3.79|<|0.0001|TWO_SIDED|95.0|-46.7|-31.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-31.8|-46.7|<0.0001
73893461|NCT04518995|147319716|SUPERIORITY||LS Mean Difference|-47.0|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-55.1|-39.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-39.0|-55.1|<0.0001
73893462|NCT04518995|147319717|SUPERIORITY||||||<|0.0001||||||P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
73893463|NCT04518995|147319717|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
73893464|NCT04518995|147319717|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
73893465|NCT04518995|147319717|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
73893466|NCT04518995|147319717|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
73893467|NCT04518995|147319717|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
73893468|NCT04518995|147319717|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
73893469|NCT04518995|147319717|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
73893470|NCT04518995|147319718|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
73893471|NCT04518995|147319718|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
73893472|NCT04518995|147319718|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
73893473|NCT04518995|147319718|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
73893474|NCT04518995|147319718|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
73799872|NCT02456740|147148031|SUPERIORITY|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-1.86|||<|0.001|TWO_SIDED|95.0|-2.95|-0.77|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.77|-2.95|< 0.001
73799873|NCT02456740|147148032|SUPERIORITY|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.57|||<|0.001|TWO_SIDED|95.0|-3.62|-1.51|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.51|-3.62|< 0.001
73799874|NCT02456740|147148032|SUPERIORITY|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-2.22|||<|0.001|TWO_SIDED|95.0|-3.28|-1.16|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.16|-3.28|< 0.001
73799875|NCT04871776|147148048|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.67|1.14|||||How vs Usual Care|We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.14|0.67|
73799876|NCT04871776|147148048|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.81|1.28||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.28|0.81|
73799877|NCT04871776|147148048|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.96|1.51||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.51|0.96|
73799878|NCT04871776|147148049|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.67|1.01||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.01|0.67|
73799879|NCT04871776|147148049|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.87|1.23||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.23|0.87|
73799880|NCT04871776|147148049|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|1.06|1.49||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.49|1.06|
73799881|NCT02750618|147148068|SUPERIORITY||Least Squares Mean Difference|0.96|||<|0.0001|TWO_SIDED|95.0|0.73|1.19|||GEE model|||||1.19|0.73|< 0.0001
73799882|NCT02750618|147148070|SUPERIORITY||Difference in LS Means|2.21|||<|0.0001|TWO_SIDED|95.0|2.07|2.35|||GEE model|||||2.35|2.07|< 0.0001
73799883|NCT02750618|147148071|SUPERIORITY||Difference in LS Means|2.23|||<|0.0001|TWO_SIDED|95.0|2.01|2.45|||GEE model|||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The least squares (LS) mean, standard error (SE), 95% confidence interval (CI) and 2-sided p-value are from the GEE model.||2.45|2.01|< 0.0001
73799884|NCT02750618|147148072|SUPERIORITY||Difference in LS Means|-1.75|||<|0.0001|TWO_SIDED|95.0|-1.98|-1.53|||GEE model|||||-1.53|-1.98|< 0.0001
73799885|NCT02750618|147148073|SUPERIORITY||Difference in LS Means|-2.02|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.8||The GEE model includes the change from baseline in RSS as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.|GEE model|||||-1.80|-2.25|< 0.0001
73799886|NCT02750618|147148074|SUPERIORITY||Difference in LS Means|1.21|||<|0.0001|TWO_SIDED|95.0|0.9|1.51|||GEE model|||||1.51|0.90|< 0.0001
73799887|NCT02750618|147148075|SUPERIORITY||Difference in LS Means|1.51|||<|0.0001|TWO_SIDED|95.0|1.27|1.76||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.|GEE|||||1.76|1.27|< 0.0001
73799888|NCT02750618|147148079|SUPERIORITY||Difference in LS Means|-82.91||||0.0004|TWO_SIDED|95.0|-128.68|-37.15|||GEE model|||Week 4||-37.15|-128.68|0.0004
73799889|NCT02750618|147148079|SUPERIORITY||Difference in LS Means|-83.84||||0.064|TWO_SIDED|95.0|-172.55|4.88|||GEE model|||Week 12||4.88|-172.55|0.0640
73799890|NCT02750618|147148079|SUPERIORITY||Difference in LS Means|-161.38|||<|0.0001|TWO_SIDED|95.0|-186.7|-136.05|||GEE model|||Week 20||-136.05|-186.70|< 0.0001
73799891|NCT02750618|147148079|SUPERIORITY||Difference in LS Means|-214.99|||<|0.0001|TWO_SIDED|95.0|-241.7|-188.28|||GEE model|||Week 40||-188.28|-241.70|< 0.0001
73799892|NCT02750618|147148079|SUPERIORITY||Difference in LS Means|-226.58|||<|0.0001|TWO_SIDED|95.0|-249.11|-204.06|||GEE model|||Week 48||-204.06|-249.11|< 0.0001
73799893|NCT02750618|147148079|SUPERIORITY||Difference in LS Means|-216.45|||<|0.0001|TWO_SIDED|95.0|-248.13|-184.77|||GEE model|||Week 56||-184.77|-248.13|< 0.0001
73799894|NCT02750618|147148079|SUPERIORITY||Difference in LS Means|-216.76|||<|0.0001|TWO_SIDED|95.0|-241.66|-191.86|||GEE model|||Week 64||-191.86|-241.66|< 0.0001
73799895|NCT02750618|147148079|SUPERIORITY||LS Mean|-231.22|||<|0.0001|TWO_SIDED|95.0|-262.51|-199.93|||GEE|||Week 76||-199.93|-262.51|< 0.0001
73799896|NCT02750618|147148079|SUPERIORITY||LS Mean|-237.78|||<|0.0001|TWO_SIDED|95.0|-262.94|-212.62|||GEE|||Week 88||-212.62|-262.94|< 0.0001
73799897|NCT02750618|147148079|SUPERIORITY||LS Mean|-218.14|||<|0.0001|TWO_SIDED|95.0|-248.21|-188.08|||GEE|||Week 100||-188.08|-248.21|< 0.0001
73799898|NCT02750618|147148079|SUPERIORITY||LS Mean|-233.91|||<|0.0001|TWO_SIDED|95.0|-255.66|-212.16|||GEE|||Week 112||-212.16|-255.66|< 0.0001
73799899|NCT02750618|147148079|SUPERIORITY||LS Mean|-252.22|||<|0.0001|TWO_SIDED|95.0|-268.51|-235.93|||GEE|||Week 124||-235.93|-268.51|< 0.0001
73799900|NCT02750618|147148079|SUPERIORITY||LS Mean|-267.89|||<|0.0001|TWO_SIDED|95.0|-293.61|-242.16|||GEE|||Week 136||-242.16|-293.61|< 0.0001
73799901|NCT02750618|147148079|SUPERIORITY||LS Mean|-248.05|||<|0.0001|TWO_SIDED|95.0|-272.85|-223.25|||GEE|||Week 148||-223.25|-272.85|< 0.0001
73799902|NCT02750618|147148079|SUPERIORITY||LS Mean|-248.47|||<|0.0001|TWO_SIDED|95.0|-270.01|-226.93|||GEE|||Week 160||-226.93|-270.01|< 0.0001
73799903|NCT01038336|147148081|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Chi-squared|||||||0.289
73799904|NCT01038336|147148082|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
73799905|NCT01038336|147148083|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||ANOVA|||||||0.072
73799906|NCT01038336|147148084|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANOVA|||||||0.030
73799907|NCT01038336|147148085|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||ANOVA|||||||0.092
73799908|NCT01038336|147148086|SUPERIORITY_OR_OTHER|||||||0.832|TWO_SIDED||||||ANOVA|||||||0.832
73799909|NCT01038336|147148087|SUPERIORITY_OR_OTHER|||||||0.454|TWO_SIDED||||||ANOVA|||||||0.454
73799910|NCT01038336|147148088|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||ANOVA|||||||0.128
73799911|NCT02763046|147148098|SUPERIORITY||Odds Ratio (OR)|1.32||||0.3512|TWO_SIDED|95.0|0.74|2.36|||Regression, Logistic|||||2.36|0.74|0.3512
73799912|NCT02763046|147148099|SUPERIORITY||Odds Ratio (OR)|1.33||||0.401|TWO_SIDED|95.0|0.68|2.6|||Regression, Logistic|||Week 12||2.60|0.68|0.4010
73799913|NCT02763046|147148099|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4382|TWO_SIDED|95.0|0.67|2.55|||Regression, Logistic|||Week 12||2.55|0.67|0.4382
73799914|NCT02763046|147148099|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0934|TWO_SIDED|95.0|0.91|3.5|||Regression, Logistic|||Week 16||3.50|0.91|0.0934
73799915|NCT02763046|147148099|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2619|TWO_SIDED|95.0|0.75|2.9|||Regression, Logistic|||Week 16||2.90|0.75|0.2619
73799916|NCT02763046|147148100|SUPERIORITY||LS (least square) Mean|-10.29|STANDARD_ERROR_OF_MEAN|6.25||0.0997|TWO_SIDED|95.0|-22.55|1.96|||Mixed Model for Repeated Measures (MMRM)|||||1.96|-22.55|0.0997
73799917|NCT02763046|147148100|SUPERIORITY||LS Mean|-12.3|STANDARD_ERROR_OF_MEAN|7.23||0.0888|TWO_SIDED|95.0|-26.47|1.87|||Mixed Model for Repeated Measures (MMRM)|||||1.87|-26.47|0.0888
73799918|NCT02763046|147148100|SUPERIORITY||LS Mean|-8.29|STANDARD_ERROR_OF_MEAN|7.18||0.2484|TWO_SIDED|95.0|-22.36|5.79|||Mixed Model for Repeated Measures (MMRM)|||||5.79|-22.36|0.2484
73799919|NCT02763046|147148101|SUPERIORITY||LS Mean|-2.06||||0.7735|TWO_SIDED|95.0|-16.11|11.98|||Mixed Model for Repeated Measures (MMRM)|||delayed tapering (W12) vs early tapering (W16)||11.98|-16.11|0.7735
73799920|NCT02763046|147148102|SUPERIORITY||LS Mean|-0.39|STANDARD_ERROR_OF_MEAN|0.3||0.1926|TWO_SIDED|95.0|-0.99|0.2|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.20|-0.99|0.1926
73799921|NCT02763046|147148102|SUPERIORITY||LS Mean|-0.46|STANDARD_ERROR_OF_MEAN|0.35||0.1914|TWO_SIDED|95.0|-1.14|0.23|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.23|-1.14|0.1914
73799922|NCT02763046|147148102|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.34||0.3397|TWO_SIDED|95.0|-1.01|0.35|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.35|-1.01|0.3397
73799923|NCT02763046|147148102|SUPERIORITY||LS Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.33||0.0384|TWO_SIDED|95.0|-1.33|-0.04|||Mixed Model for Repeated Measures (MMRM)|||Week 16||-0.04|-1.33|0.0384
73799924|NCT02763046|147148102|SUPERIORITY||LS Mean|-0.41|STANDARD_ERROR_OF_MEAN|0.33||0.2116|TWO_SIDED|95.0|-1.05|0.23|||Mixed Model for Repeated Measures (MMRM)|||Week 16||0.23|-1.05|0.2116
73799925|NCT02763046|147148103|SUPERIORITY||LS Mean|0.63|STANDARD_ERROR_OF_MEAN|1.02||0.5384|TWO_SIDED|95.0|-1.38|2.63|||Mixed Model for Repeated Measures (MMRM)|||||2.63|-1.38|0.5384
73799926|NCT02763046|147148103|SUPERIORITY||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|1.18||0.9251|TWO_SIDED|95.0|-2.43|2.21|||Mixed Model for Repeated Measures (MMRM)|||||2.21|-2.43|0.9251
73799927|NCT02763046|147148103|SUPERIORITY||LS Mean|1.36|STANDARD_ERROR_OF_MEAN|1.16||0.2432|TWO_SIDED|95.0|-0.93|3.66|||Mixed Model for Repeated Measures (MMRM)|||||3.66|-0.93|0.2432
73799928|NCT01634048|147148118|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73799929|NCT05017246|147148140|SUPERIORITY||Mean Difference (Final Values)|-44.9||||0.0249|TWO_SIDED|95.0|-84.0|-5.8|||Two-sample t-test|Unadjusted analysis|Intrathecal - Epidural|||-5.8|-84.0|0.0249
73799930|NCT05017246|147148141|SUPERIORITY||Risk Ratio (RR)|1.04||||0.94|TWO_SIDED|95.0|0.36|3.01|||Chi-squared||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||3.01|0.36|0.94
73799931|NCT05017246|147148142|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.59|TWO_SIDED|95.0|-1.01|0.48|||Bootstrap resampling method|Bootstrap resampling method based on raw data was applied for due to highly right-skewed data (5,000 Bootstrap samples were selected).|Intrathecal - Epidural|||0.48|-1.01|0.59
73799932|NCT05017246|147148143|SUPERIORITY||Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.61|1.48|||Chi-squared||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||1.48|0.61|0.82
73799933|NCT05017246|147148146|SUPERIORITY||Risk Ratio (RR)|1.56||||0.67|TWO_SIDED|95.0|0.27|8.95|||Fisher Exact||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||8.95|0.27|0.67
73799934|NCT05017246|147148147|SUPERIORITY||Risk Ratio (RR)|2.08||||0.61|TWO_SIDED|95.0|0.19|22.2|||Fisher Exact||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||22.2|0.19|0.61
73799935|NCT01495000|147148149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.05|||<|0.0001|TWO_SIDED|95.0|1.91|4.19|||ANCOVA|||||4.19|1.91|<0.0001
73799936|NCT01514461|147148167|SUPERIORITY_OR_OTHER||% change from reference treatment|-28.78||||0.0538|TWO_SIDED|95.0|-55.69|14.46|||Mixed Models Analysis|Mixed Model of Repeated Measurements||||14.46|-55.69|0.0538
73799937|NCT01514461|147148167|SUPERIORITY_OR_OTHER||% change from reference treatment|-40.88||||0.0182|TWO_SIDED|95.0|-63.99|-2.94|||Mixed Models Analysis|Mixed Model of Repeated Measurements||||-2.94|-63.99|0.0182
73893475|NCT04518995|147319718|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
73893476|NCT04518995|147319718|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
73893477|NCT04518995|147319718|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
73893478|NCT04518995|147319719|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.7|-1.2|<0.0001
73893479|NCT04518995|147319719|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.9|-1.5|<0.0001
73893480|NCT04518995|147319719|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-0.9|-1.4|<0.0001
73893481|NCT04518995|147319719|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.3|-1.9|<0.0001
73893482|NCT04518995|147319719|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.2|-1.8|<0.0001
73893483|NCT04518995|147319719|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.3|-1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.6|-2.3|<0.0001
73893484|NCT04518995|147319719|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.3|-2.0|<0.0001
73799938|NCT00780338|147148231|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.58
73893485|NCT04518995|147319719|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.7|-2.5|<0.0001
73893486|NCT04518995|147319720|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.9|-0.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.3|-0.9|<0.0001
73893487|NCT04518995|147319720|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.3|-0.6||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.6|-1.3|<0.0001
73893488|NCT04518995|147319720|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-0.9|-1.6|<0.0001
73893489|NCT04518995|147319720|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.1|-1.4||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.4|-2.1|<0.0001
73893490|NCT04518995|147319720|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.7|-1.0||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.0|-1.7|<0.0001
73893491|NCT04518995|147319720|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.3|-1.5||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.5|-2.3|<0.0001
73893492|NCT04518995|147319720|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.3|-2.0|<0.0001
73893493|NCT04518995|147319720|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.6|-1.8||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.6|<0.0001
73893494|NCT04518995|147319721|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.06|0.12||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.12|0.06|<0.0001
73893495|NCT04518995|147319721|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.12|0.22||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.22|0.12|<0.0001
73893496|NCT04518995|147319721|SUPERIORITY||Risk Difference (RD)|0.28|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.23|0.33||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.33|0.23|<0.0001
73893497|NCT04518995|147319721|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.32|0.45||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.45|0.32|<0.0001
73893498|NCT04518995|147319721|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.01||0.0006|TWO_SIDED|95.0|0.02|0.06||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.06|0.02|0.0006
73893499|NCT04518995|147319721|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.14|0.06|<0.0001
73893500|NCT04518995|147319721|SUPERIORITY||Risk Difference (RD)|0.19|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.15|0.23||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.23|0.15|<0.0001
73893501|NCT04518995|147319721|SUPERIORITY||Risk Difference (RD)|0.3|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.24|0.37||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.37|0.24|<0.0001
73893502|NCT04518995|147319722|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|0.3|1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.2|0.3|0.0010
73893503|NCT04518995|147319722|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|0.6|1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.6|0.6|<0.0001
73893504|NCT04518995|147319722|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.2|2.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.2|1.2|<0.0001
73893505|NCT04518995|147319722|SUPERIORITY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.4|2.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.4|1.4|<0.0001
73893506|NCT04518995|147319723|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.5|1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.3|0.5|<0.0001
73893507|NCT04518995|147319723|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|1.0|1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.8|1.0|<0.0001
73893508|NCT04518995|147319723|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.0|2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.0|1.0|<0.0001
73893509|NCT04518995|147319723|SUPERIORITY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.4|2.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.4|1.4|<0.0001
73893510|NCT04518995|147319724|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.5|-1.0|< 0.0001
73893511|NCT04518995|147319724|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.8|-1.3|< 0.0001
73893512|NCT04518995|147319724|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-0.8|-1.2|< 0.0001
73893513|NCT04518995|147319724|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.1|-1.6|< 0.0001
73893514|NCT04518995|147319724|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-0.8|-1.3|< 0.0001
73893515|NCT04518995|147319724|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.2|-1.7|< 0.0001
73893516|NCT04518995|147319724|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.0|-1.5|< 0.0001
73893517|NCT04518995|147319724|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.3|-1.8|< 0.0001
73893518|NCT04518995|147319725|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.17|0.34||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.34|0.17|< 0.0001
73893519|NCT04518995|147319725|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.23|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.42|0.23|< 0.0001
73799939|NCT00780338|147148233|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.61
73799940|NCT00780338|147148234|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.09
73799941|NCT00780338|147148235|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.01
73799942|NCT00780338|147148236|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.00
73799943|NCT00780338|147148237|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.45
73799944|NCT00780338|147148238|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.65
73799945|NCT00780338|147148239|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.00
73799946|NCT00780338|147148240|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.61
73799947|NCT00780338|147148241|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.02
73799948|NCT02002221|147148246|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.08|-0.73|||ANCOVA|||H0: δ vildagliptin 50 mg bid = δ placebo versus H1: δ Vildagliptin 50 mg bid \< δ placebo,||-0.73|-1.08|< 0.001
73799949|NCT02023983|147148261|OTHER|||||||0.765|||||||Fisher Exact|||||||0.765
73799950|NCT02023983|147148262|OTHER|||||||1|||||||Fisher Exact|||||||1
73799951|NCT02105467|147148263|SUPERIORITY_OR_OTHER||||||<|0.001|||||||One-sided, one-sample exact test|||Superiority of SVR12 in the Immediate Treatment group was tested against the historical response rate of 73%.||||<0.001
73799952|NCT02105467|147148264|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-10.8|9.6|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.|||9.6|-10.8|
73799953|NCT02105467|147148265|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-4.4|2.0|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.|||2.0|-4.4|
73799954|NCT01518322|147148277|SUPERIORITY_OR_OTHER||Kappa Statistics|0.049|||||TWO_SIDED|95.0|-0.0895|0.1875||||||Kappa statistics were used to determine the level of agreement between FeNO measurements and asthma diagnosis using the a dichotomous schemes a measurement greater than 35 ppb for children under the age of 12 years or greater than 50 ppb for subjects at least 12 years of age was considered high.||0.1875|-0.0895|
73799955|NCT02792517|147148315|OTHER||Least Squares Geometric Mean Ratio|1.04|||||TWO_SIDED|90.0|0.88|1.22|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.22|0.88|
73799956|NCT02792517|147148316|OTHER||Least Squares Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.91|1.14|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.14|0.91|
73799957|NCT02792517|147148317|OTHER||Least Squares Geometric Mean Ratio|1.06|||||TWO_SIDED|90.0|0.97|1.16|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.16|0.97|
73799958|NCT02792517|147148318|OTHER||Least Squares Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.96|1.1|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.10|0.96|
73799959|NCT02792517|147148319|OTHER||Least Squares Geometric Mean Ratio|1.05|||||TWO_SIDED|90.0|0.9|1.23|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.23|0.90|
73799960|NCT02792517|147148320|OTHER||Least Squares Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.94|1.12|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.12|0.94|
73799961|NCT01015534|147148402|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9||||0.019|TWO_SIDED|95.0|1.3|12.9||The sample size was calculated with a two-sided test,a type-I error probability of 0.05 and a power of 0.80,Twenty- eight patients in each treatment arm were required to detect a difference in ORR of 0.29|Chi-squared|||||12.9|1.3|0.019
73799962|NCT01015534|147148403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.688||||0.704|TWO_SIDED|95.0|0.138|3.422|||Fisher Exact|||||3.422|.138|.704
73799963|NCT01015534|147148404|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Log Rank|||||||0.84
73799964|NCT03737357|147148466|NON_INFERIORITY|The tolerance range or non-inferiority margin characterizes the largest absolute difference which is considered to be dismissible. A MBL of less than 0.5mm within the first year after implant loading constitutes an acceptable clinical standard(10, 18, 19). In this clinical trial, a non-inferiority margin of 20% of the acceptable clinical standard was chosen, which amounts to 0.1mm.|paired difference|0.01||||0.074|TWO_SIDED||||||t-test, 1 sided|Non-inferiority one-sided paired t-tests using a non-inferiority margin of -0.10mm.|The paired difference is (SLActive® bone level change from baseline (CFB) - SLA® CFB (i.e. resorption))||In the PP population, the paired difference between SLActive® and SLA® bone level change from baseline (CFB) was estimated at 0.01 mm with a standard deviation of 0.444 mm (95% CI: -Inf, 0.11; p = 0.074), based on a one-sided paired t-test with a non-inferiority margin of 0.10 mm.|||0.074
73799965|NCT01320293|147148476|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: Percent change in endothelial function from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||<0.05
73799966|NCT01320293|147148477|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: change in IL-6 levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||<0.05
73799967|NCT01320293|147148478|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||Null hypothesis: change in adiponectin levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||0.05
73799968|NCT04782076|147148496|OTHER||LS Mean Difference (Final Values)|1.43|||||TWO_SIDED|90.0|1.33|1.55|||Mixed Models Analysis|Least Squares Mean (LS Mean)||||1.55|1.33|
73799969|NCT04782076|147148497|OTHER||LS Mean Difference (Final Values)|1.38|||||TWO_SIDED|90.0|1.3|1.46|||Mixed Models Analysis|||||1.46|1.30|
73799970|NCT04910100|147148505|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|6.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
73799971|NCT04910100|147148505|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|9.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
73799972|NCT04910100|147148505|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
73799973|NCT04910100|147148505|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
73799974|NCT04910100|147148505|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
73799975|NCT04910100|147148505|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
73799976|NCT00856492|147148517|SUPERIORITY_OR_OTHER|||||||0.019|||||||Chi-squared|||||||0.019
73799977|NCT00856492|147148518|SUPERIORITY_OR_OTHER|||||||0.64|||||||Log Rank|||||||0.64
73799978|NCT00856492|147148519|SUPERIORITY_OR_OTHER|||||||0.71|||||||Log Rank|||||||0.71
73799979|NCT00070564|147148535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.32||||0.022|TWO_SIDED|95.0|1.04|1.68|||Log Rank|||||1.68|1.04|0.022
73799980|NCT00070564|147148535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.24||||0.072|TWO_SIDED|95.0|0.98|1.59|||Log Rank|||||1.59|0.98|0.072
73799981|NCT00070564|147148535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12||||0.38|TWO_SIDED|95.0|0.87|1.44|||Log Rank|||||1.44|0.87|0.38
73799982|NCT00070564|147148535|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Log Rank|||||||0.11
73799983|NCT00070564|147148535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.733|TWO_SIDED|95.0|0.61|1.41|||Log Rank|||||1.41|0.61|0.733
73799984|NCT00070564|147148536|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.44||||0.013|TWO_SIDED|95.0|1.08|1.93|||Log Rank|||||1.93|1.08|0.013
73799985|NCT00070564|147148536|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.46||||0.011|TWO_SIDED|95.0|1.09|1.95|||Log Rank|||||1.95|1.09|0.011
73799986|NCT00070564|147148536|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.24||||0.17|TWO_SIDED|95.0|0.91|1.68|||Log Rank|||||1.68|0.91|0.17
73799987|NCT00070564|147148536|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Log Rank|||||||0.040
73799988|NCT00070564|147148536|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.724|TWO_SIDED|95.0|0.54|1.53|||Log Rank|||||1.53|0.54|0.724
73799989|NCT00070564|147148538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|||||||Log Rank|||Overall treatment differences.||||0.67
73799990|NCT00070564|147148538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.42
73799991|NCT00070564|147148539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Log Rank|||Test of overall treatment differences.||||0.90
73799992|NCT00070564|147148539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.52
73799993|NCT00070564|147148540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076|||||||Log Rank|||Test of overall treatment differences.||||0.076
73799994|NCT00070564|147148540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.018
73799995|NCT00070564|147148541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Log Rank|||Test of overall treatment differences.||||0.062
73799996|NCT00070564|147148541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.010
73799997|NCT00070564|147148542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Log Rank|||Test of overall treatment differences.||||0.69
73799998|NCT00070564|147148542|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||Log Rank|||Test of interaction two treatments: AC and paclitaxel.||||0.66
73799999|NCT00070564|147148543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Log Rank|||Test of overall treatment differences||||0.40
73800000|NCT00070564|147148543|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.28
73800001|NCT00931528|147148544|SUPERIORITY_OR_OTHER||Difference in percentages|5.0||||0.49|TWO_SIDED|95.0|1.0|9.0|||Chi-squared|||Sample size calculations were based on the hypothesis that the use of tadalafil would statistically significant increase the proportion of patients maintaining spontaneous erectile function compared to the use of placebo. Based on a 2-sided Fisher exact test with alpha=0.05, 91 patients/arm would provide 80% statistical power to detect an increase from 20% to 40% in spontaneous erectile response at weeks 28-30. Although designed for the Fisher exact test, Chi-square was used and reported.||9|1|0.49
73800002|NCT00931528|147148544|SUPERIORITY|||||||0.2386|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped: ethnicity, Zubrod, T stage, prostate-specific antigen (PSA).) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.2386
73800003|NCT00931528|147148544|SUPERIORITY|||||||0.7908|||||||Regression, Linear|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.)The results for each explanatory variable are reported separately. RT method is reported here.||||0.7908
73800004|NCT00931528|147148544|SUPERIORITY|||||||0.0467|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.0467
73800005|NCT00931528|147148544|SUPERIORITY|||||||0.0068|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.||||0.0068
73800006|NCT00931528|147148545|SUPERIORITY|||||||0.93|||||||Chi-squared|2-sided significance level = 0.05||Year 1||||0.93
73800007|NCT00931528|147148545|SUPERIORITY|||||||0.58|||||||Chi-squared|2-sided significance level = 0.05||Year 2||||0.58
73800008|NCT00931528|147148545|SUPERIORITY|||||||0.9501|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.9501
73800009|NCT00931528|147148545|SUPERIORITY|||||||0.102|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.||||0.1020
73800010|NCT00931528|147148545|SUPERIORITY|||||||0.1855|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.1855
73800011|NCT00931528|147148545|SUPERIORITY|||||||0.5739|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.5739
73800012|NCT00931528|147148545|SUPERIORITY|||||||0.0422|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.||||0.0422
73800013|NCT00931528|147148545|SUPERIORITY|||||||0.5237|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.5237
73800014|NCT00931528|147148545|SUPERIORITY|||||||0.477|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.||||0.4770
73800015|NCT00931528|147148546|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.97
73800016|NCT00931528|147148546|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.99
73800017|NCT00931528|147148546|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.24
73800018|NCT00931528|147148547|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.70
73800019|NCT00931528|147148547|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.65
73800020|NCT00931528|147148547|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|Significance level = 0.05||||||0.72
73800021|NCT00931528|147148548|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.14
73800022|NCT00931528|147148548|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.64
73800023|NCT00931528|147148548|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.18
73800024|NCT00931528|147148549|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.67
73800025|NCT00931528|147148549|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.98
73800026|NCT00931528|147148549|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.96
73800027|NCT00931528|147148550|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.86
73800028|NCT00931528|147148550|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.93
73800029|NCT00931528|147148550|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.52
73800030|NCT02058069|147148576|NON_INFERIORITY_OR_EQUIVALENCE|The Alternative Hypothesis: The Investigational Device (RIO) true event rate is non-inferior to 0.066 (event rate for manual TKA) with a non-inferiority margin of 0.06. The 0.066 rate is based on literature and 0.06 was determined in consultation with FDA.|Rare Adverse Event Rate|0.0|||||ONE_SIDED|95.0||0.0331|||||If the upper bound is \<0.126 then the primary composite safety endpoint is met. After the surgeon completed the procedure, at the conclusion of the participant's hospital stay, and 3 months post-operative were used in this single analysis.|||0.0331||
73800031|NCT02058069|147148578|OTHER|The analysis was performed using standard OC curves generated using Sample Size Analyzer® version 2.0 by Taylor Enterprise Inc. (Dr. Wayne A. Taylor).|Alignment Difference <4.38 Degrees|1.0|||||ONE_SIDED|95.0|0.966||||||Estimation Parameter is: proportion of participants with limb alignment difference \<4.38 degrees If the lower bound is \>0.95 then the assessment passes.||||0.966|
73800032|NCT02058069|147148579|NON_INFERIORITY|The upper bound for the one-sided 95% confidence interval will be compared with -9. If the upper bound is less than -9, then non-inferiority holds.|Mean Difference (Final Values)|-33.1|||<|0.001|ONE_SIDED|95.0||-29.6|||t-test, 2 sided||If the upper bound is less than -9, then non-inferiority holds.|Change from pre-op to 3 months||-29.6||<0.001
73800033|NCT02676882|147148582|OTHER|A Chi Squared analysis was performed to determine how the rate of relapse in Group 1 (27.3%) compared to that of historical controls in the literature (67.7%). (Cohen, JAMA 2006)||||||0.005||||||A priori threshold for statistical significance: p\<0.05|Chi-squared|||||||0.005
73800034|NCT02676882|147148583|OTHER|A one-way repeated measures ANOVA was used to examine the overall course of Group 2 participants' MADRS scores. (F(6, 29)=5.16, p=0.001).||||||0.001||||||a priori threshold for statistical significance: p \<0.05|ANOVA|||||||0.001
73800035|NCT02568072|147148584|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
73800036|NCT02568072|147148585|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
73800037|NCT02568072|147148586|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
73800038|NCT01288807|147148589|OTHER|repeated measure ANOVA|||||<|0.01|||||||ANOVA|||||||< 0.01
73800039|NCT01288807|147148590|OTHER|two-tailed paired t-test|||||<|0.05|||||||t-test, 2 sided|||This analysis looks at the cold threshold measured in degrees celcius before and after treatment.||||< 0.05
73800040|NCT01288807|147148591|OTHER||||||>|0.05|||||||t-test, 2 sided|||This analysis looks at the pressure threshold measured in pounds per square inch before and after treatment||||> 0.05
73800041|NCT01288807|147148592|OTHER||||||>|0.05||||||one-way repeated measure ANOVA|ANOVA|||||||> 0.05
73800042|NCT02321111|147148600|OTHER|ANOVA||||||0.02|||||||ANOVA|||||||0.02
73800043|NCT00707239|147148632|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.4|||||TWO_SIDED|70.0|-21.6|10.9||||||Cure: Confidence interval (CI) was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70 percent (%) CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||10.9|-21.6|
73800044|NCT00707239|147148632|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.0|||||TWO_SIDED|70.0|-6.1|24.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||24.8|-6.1|
73800045|NCT00707239|147148633|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2|||||TWO_SIDED|70.0|-14.3|14.0||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||14.0|-14.3|
73800046|NCT00707239|147148633|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.5|||||TWO_SIDED|70.0|4.3|31.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||31.8|4.3|
73800047|NCT00707239|147148636|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-18.5|||||TWO_SIDED|70.0|-39.6|4.2||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||4.2|-39.6|
73800048|NCT00707239|147148636|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|70.0|-23.8|20.9||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||20.9|-23.8|
73800049|NCT00707239|147148637|SUPERIORITY_OR_OTHER|||||||0.527|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||Nausea: p-value was calculated using 2-tail Fischer's exact test.||||0.527
73800050|NCT00707239|147148637|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||Vomiting: p-value was calculated using 2-tail Fischer's exact test.||||0.390
73893520|NCT04518995|147319725|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.27|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.42|0.27|< 0.0001
73893521|NCT04518995|147319725|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.3|0.48||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.48|0.30|< 0.0001
73893522|NCT04518995|147319725|SUPERIORITY||Risk Difference (RD)|0.34|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.26|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.42|0.26|< 0.0001
73893523|NCT04518995|147319725|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.34|0.51||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.51|0.34|< 0.0001
73893524|NCT04518995|147319725|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.29|0.44||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.44|0.29|< 0.0001
73893525|NCT04518995|147319725|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.35|0.53||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.53|0.35|< 0.0001
73893526|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.5|-0.9|<0.0001
73893527|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.7|-1.2|<0.0001
73893528|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-0.6|-1.1|<0.0001
73893529|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-1.0|-1.4|<0.0001
73800051|NCT00707239|147148638|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.||||1.000
73893530|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-0.8|-1.2|<0.0001
73893531|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1.1|-1.6|<0.0001
73893532|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-0.8|-1.3|<0.0001
73893533|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.2|-1.7|<0.0001
73893534|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 12||-0.4|-0.8|<0.0001
73893535|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 12||-0.7|-1.1|<0.0001
73800052|NCT00707239|147148639|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.||||1.000
73800053|NCT00707239|147148645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0479||||0.78|TWO_SIDED|95.0|0.754|1.46|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced nausea and did not experience nausea.||1.46|0.754|0.78
73893536|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 16||-0.5|-0.9|<0.0001
73893537|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 16||-0.8|-1.3|<0.0001
73893538|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 20||-0.7|-1.1|<0.0001
73800054|NCT00707239|147148645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84644||||0.356|TWO_SIDED|95.0|0.593|1.21|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced vomiting and did not experience vomiting.||1.21|0.593|0.356
73800055|NCT00707239|147148646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0054||||0.836|TWO_SIDED|95.0|0.956|1.06|||Regression, Logistic|||Statistical analysis was carried out between categories, cure and failure/indeterminate.||1.06|0.956|0.836
73800056|NCT00707239|147148650|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||Intravenous antibiotic treatment: One-way analysis of variance (ANOVA) with treatment as factor was used to calculate p-value.||||0.245
73800057|NCT00707239|147148650|SUPERIORITY_OR_OTHER|||||||0.484|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||Hospital stay: One-way ANOVA with treatment as factor was used to calculate p-value.||||0.484
73800058|NCT00707239|147148650|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||ICU stay: One-way ANOVA with treatment as factor was used to calculate p-value.||||0.192
73800059|NCT00663793|147148697|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 8 per group was estimated to confer an 80% power to detect a 40% difference in testosterone AUC with a standard deviation of 20% at an alpha of 0.05|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon sign-rank|||||||<0.05
73800060|NCT00663793|147148698|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was performed for this pilot study.|||||<|0.05||95.0|||||Wilcoxon sign-rank|||||||<0.05
73800061|NCT00663793|147148699|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was performed for this pilot study||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Area-under-the-curve for serum estradiol||||0.05
73800062|NCT01400477|147148700|SUPERIORITY|||||||0.89||||||A priori vape was \<0.05|ANOVA|df 1, 37||||||0.89
73800063|NCT03743051|147148702|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|1.345|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|0.718|1.971|||ANOVA|||"To declare anamorelin superior to placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change in body weight from baseline over 12 weeks (H0w) and the corresponding alternative hypothesis (H1w) were:~H0w: MWa = MW; H1w: MWa ≠ MWp~Where MWa is the mean change in body weight from baseline over 12 weeks for the anamorelin arm and MWp is the mean change in body weight from baseline over 12 weeks for the placebo arm."||1.971|0.718|<0.0001
73800064|NCT03743051|147148703|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|0.622|STANDARD_ERROR_OF_MEAN|0.434||0.1514|TWO_SIDED|95.0|-0.228|1.472|||ANOVA|||"To declare anamorelin superior to the placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change from baseline over 12 weeks in patient 5-IASS (H0A) and the corresponding alternative (H1A) were:~H0A: MAa = MAp; H1A: MAa ≠ MAp~Where MAa is the mean change from baseline over 12 weeks in 5-IASS for the anamorelin arm and MAp is the mean change from baseline over 12 weeks in 5-IASS for the placebo arm."||1.472|-0.228|0.1514
73800065|NCT03743051|147148704|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.532|<|0.0001|TWO_SIDED|95.0|1.367|3.453|||ANOVA|||||3.453|1.367|<0.0001
73800066|NCT03743051|147148705|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|1.336|STANDARD_ERROR_OF_MEAN|0.484||0.0057|TWO_SIDED|95.0|0.388|2.284|||ANOVA|||||2.284|0.388|0.0057
73800067|NCT03743051|147148706|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|1.027|STANDARD_ERROR_OF_MEAN|0.403||0.0108|TWO_SIDED|95.0|0.238|1.816|||ANOVA|||||1.816|0.238|0.0108
73800068|NCT03743051|147148707|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.535|STANDARD_ERROR_OF_MEAN|0.475||0.2605|TWO_SIDED|95.0|-0.397|1.466|||ANOVA|||||1.466|-0.397|0.2605
73800069|NCT01422200|147148708|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
73800070|NCT00811733|147148711|SUPERIORITY_OR_OTHER||percentage of participants|47.0|||||TWO_SIDED|95.0|21.3|73.4|||||The estimated value represents the percentage of participants with OR.|||73.4|21.3|
73800071|NCT00811733|147148711|SUPERIORITY_OR_OTHER||percentage of participants|68.0|||||TWO_SIDED|95.0|45.1|86.1|||||The estimated value represents the percentage of participants with OR.|||86.1|45.1|
73800072|NCT00811733|147148712|SUPERIORITY_OR_OTHER||percentage of participants|33.0|||||TWO_SIDED|95.0|11.8|61.6|||||The estimated value represents the percentage of participants with OR.|||61.6|11.8|
73800073|NCT00811733|147148712|SUPERIORITY_OR_OTHER||percentage of participants|64.0|||||TWO_SIDED|95.0|40.7|82.8|||||The estimated value represents the percentage of participants with OR.|||82.8|40.7|
73800074|NCT01113892|147148753|NON_INFERIORITY|"The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate at 6 months for FUSION Bioline (PF), and the primary patency rate at 6 months for EXXCEL (PE).~H0: PF - PE \< - 0.15; HA: PF - PE \> - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products."|Mean Difference (Net)|16.4|||<|0.0001|TWO_SIDED|95.0|2.7|29.9||The threshold for significance was p = .05|Exact 1-sided test||Difference = Patency (Fusion Bioline) - Patency (EXXCEL)|It was calculated that 200 participants randomized in a 1:1 fashion would have at least 80% power to detect a difference of 15% in the number of participants with primary patency between FUSION Bioline and EXXCEL groups at 6 months. It was assumed that the ratio of Above-Knee to Below-Knee procedures was 60:40; based on this, the primary patency rate for the combined Above-Knee and Below-Knee patients was 79%. Assumptions included a 10% withdrawal rate prior to the 6-month evaluation.||29.9|2.7|<.0001
73800075|NCT01113892|147148754|EQUIVALENCE|Fisher's Exact test was used to evaluate whether subjects with any MALE event or POD were homogeneous across the treatment arms.||||||0.033|ONE_SIDED|95.0|||||Fisher Exact|||The number and percentage of subjects with a MALE or POD event were summarized by treatment group.||||.033
73800076|NCT01113892|147148755|OTHER|||||||0.017|||||||Chi-squared|Proportion of subjects who achieved primary assisted patency for both treatment groups were compared using a Chi-Square test||||||.017
73800077|NCT01113892|147148756|OTHER|||||||0.137|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi-Square test||||||.137
73800078|NCT01113892|147148757|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Difference between groups were compared with the Wilcoxon Rank Sum Test||||<.0001
73800079|NCT01113892|147148759|NON_INFERIORITY|"Repeated 6 month analyses for 12 month results.The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate for FUSION Bioline (PF), and the primary patency rate for EXXCEL (PE).~H0: PF - PE \< - 0.15; HA: PF - PE \> - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products, with a p-value ≤ .05 indicating significance."|Mean Difference (Net)|9.5||||0.0001|TWO_SIDED|95.0|-4.8|23.0|||Exact 1-sided test|||||23.0|-4.8|.0001
73800080|NCT01113892|147148761|OTHER|||||||0.181|||||||Chi-squared|Proportion of subjects who achieve primary assisted patency for both treatment groups will be compared using a Chi-Square test||||||.181
73800081|NCT01113892|147148763|OTHER|||||||0.68|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi Square test||||||.68
73800082|NCT02200055|147148782|SUPERIORITY_OR_OTHER|This measurement was collected for each participant. A pre-operative and post-operative bioimpedance measurement was taken.|Mean Difference (Final Values)|0.53|||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
73800083|NCT03442751|147148788|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0004|TWO_SIDED|95.0|-1.5|-0.4|||ANCOVA|||Repeated measures mixed analysis of covariance model||-0.4|-1.5|0.0004
73800084|NCT03442751|147148789|SUPERIORITY|last observation carried forward was used to impute missing Month 12 data|Mean Difference (Net)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|||repeated measures mixed analysis of covariance model||-0.6|-1.6|<0.0001
73800085|NCT00793455|147148805|SUPERIORITY_OR_OTHER||Rate Ratio|3.1|||<|0.05|TWO_SIDED|95.0|1.5|6.2|||Chi-squared|||We compared the outcomes in the intervention and control groups using rate ratios and chi square test at 3 and 6 months, a 2 sided test with a p value \< .05 was used to determine significance. The study was powered to detect a 10-percentage point difference in screening completion between intervention and control groups if the control rate of completion as 20% or less with 80% power.||6.2|1.5|<0.05
73800086|NCT00793455|147148806|SUPERIORITY_OR_OTHER||Rate Ratio|1.5|||<|0.05|TWO_SIDED|95.0|1.03|2.2|||Chi-squared|||Same as primary outcome.||2.2|1.03|<0.05
73800087|NCT07034820|147148807|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.001|TWO_SIDED|95.0|48.0|64.0||A priori statistical significance threshold for the primary endpoint was set at a two-sided alpha level of 0.05. No adjustment for multiple comparisons was applied to the primary outcome analysis, as it was the sole primary endpoint.|Chi-squared||The Risk Difference (RD) indicates the absolute difference in hemorrhoid regression rates between the Nimsai Herbal Group and the Placebo Group. Calculation: Nimsai Herbal (78%) - Placebo (22%) = 56%.|Powered for 56% difference (80% power, alpha=0.05) to detect the anticipated difference in hemorrhoid regression rates between groups. The sample size of N=300 (150 participants per arm) was calculated based on an expected regression rate of 22% in the placebo group and 78% in the Nimsai Herbal group. This ensured sufficient statistical power for the primary efficacy analysis.||64|48|<0.001
73800088|NCT02845700|147148808|SUPERIORITY|||||||0.08|||||||ANOVA|2 (time) x 2 (group) x 5 (dilution %) repeated measures ANOVA||||||.08
73800089|NCT02845700|147148809|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|t(4) = -1.19, p = .39||Post-hoc estimates of observed power for the difference between group means was calculated to be .15.||||.39
73800090|NCT02845700|147148812|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|t(4) = 0.66, p = .54||Post-hoc estimates of observed power for the difference between group means was calculated to be .08.||||.54
73800091|NCT02452476|147148813|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.93|TWO_SIDED|95.0|-0.4|0.44|||Mixed model for repeated measurements|||"Day 1, 30 min post dose.~SpO2/FiO2 and FiO2 (%) over the first 24 hours: analyzed using a linear mixed model for repeated measures (MMRM) including treatment, timepoint, treatment by timepoint interaction, investigational site and gestational age (GA) group as fixed effects, and predose values as covariates. The adjusted mean difference between treatments, and their 95% confidence intervals (CIs) at each timepoint and averaged over the first 24 hours were estimated by the model."||0.44|-0.40|0.930
73800092|NCT02452476|147148813|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.346|TWO_SIDED|95.0|-0.59|0.21|||Mixed model for repeated measurements|||Day 1, 1 h post dose||0.21|-0.59|0.346
73800093|NCT02452476|147148813|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.549|TWO_SIDED|95.0|-0.43|0.23|||Mixed model for repeated measurements|||Day 1, 3 h post dose||0.23|-0.43|0.549
73800094|NCT02452476|147148813|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.539|TWO_SIDED|95.0|-0.43|0.23|||Mixed model for repeated measurements|||Day 1, 6 h post dose||0.23|-0.43|0.539
73800095|NCT02452476|147148813|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.491|TWO_SIDED|95.0|-0.21|0.43|||Mixed model for repeated measurements|||Day 1, 12 h post dose||0.43|-0.21|0.491
73800096|NCT02452476|147148813|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.623|TWO_SIDED|95.0|-0.22|0.37|||Mixed model for repeated measurements|||Day 1, 18 h post dose||0.37|-0.22|0.623
73800097|NCT02452476|147148813|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.608|TWO_SIDED|95.0|-0.25|0.43|||Mixed model for repeated measurements|||Day 1, 24 h post dose||0.43|-0.25|0.608
73800098|NCT02452476|147148813|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.869|TWO_SIDED|95.0|-0.35|0.3|||Mixed Models Analysis|||"Day 2, post dose~SpO2/FiO2 was compared between treatments at the remaining post-treatment time points (i.e., Days 2, 3, 5, 7): analyzed using mixed model including treatment, investigational site and gestational age group as fixed effects and pre-dose ratio as covariate."||0.30|-0.35|0.869
73800099|NCT02452476|147148813|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.833|TWO_SIDED|95.0|-0.38|0.31|||Mixed Models Analysis|||Day 3, post dose||0.31|-0.38|0.833
73800100|NCT02452476|147148813|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.772|TWO_SIDED|95.0|-0.39|0.29|||Mixed Models Analysis|||Day 5, post dose||0.29|-0.39|0.772
73800101|NCT02452476|147148813|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.963|TWO_SIDED|95.0|-0.33|0.35|||Mixed Models Analysis|||Day 7, post dose||0.35|-0.33|0.963
73800102|NCT02452476|147148814|SUPERIORITY||Mean Difference (Final Values)|-1.94||||0.519|TWO_SIDED|95.0|-7.87|3.99|||Mixed model for repeated measurements|||Day 1, 30 min post dose||3.99|-7.87|0.519
73800103|NCT02452476|147148814|SUPERIORITY||Mean Difference (Final Values)|2.45||||0.282|TWO_SIDED|95.0|-2.04|6.93|||Mixed model for repeated measurements|||Day 1, 1 h post dose||6.93|-2.04|0.282
73800104|NCT02452476|147148814|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.854|TWO_SIDED|95.0|-4.04|4.86|||Mixed model for repeated measurements|||Day 1, 3 h post dose||4.86|-4.04|0.854
73800105|NCT02452476|147148814|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.861|TWO_SIDED|95.0|-5.0|4.19|||Mixed model for repeated measurements|||Day 1, 6 h post dose||4.19|-5.00|0.861
73800106|NCT02452476|147148814|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.117|TWO_SIDED|95.0|-6.24|0.7|||Mixed model for repeated measurements|||Day 1, 12 h post dose||0.70|-6.24|0.117
73800107|NCT02452476|147148814|SUPERIORITY||Mean Difference (Final Values)|-1.92||||0.185|TWO_SIDED|95.0|-4.79|0.94|||Mixed model for repeated measurements|||Day 1, 18 h post dose||0.94|-4.79|0.185
73800108|NCT02452476|147148814|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.678|TWO_SIDED|95.0|-5.82|3.8|||Mixed model for repeated measurements|||Day 1, 24 h post dose||3.80|-5.82|0.678
73800109|NCT02452476|147148814|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.961|TWO_SIDED|95.0|-3.49|3.67|||Mixed Models Analysis|||"Day 2, post dose~SpO2/FiO2 was compared between treatments at the remaining post-treatment time points (i.e., Days 2, 3, 5, 7): analyzed using mixed model including treatment, investigational site and gestational age group as fixed effects and pre-dose ratio as covariate."||3.67|-3.49|0.961
73800110|NCT02452476|147148814|SUPERIORITY||Mean Difference (Final Values)|-1.53||||0.544|TWO_SIDED|95.0|-6.53|3.46|||Mixed Models Analysis|||Day 3, post dose||3.46|-6.53|0.544
73800111|NCT02452476|147148814|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.492|TWO_SIDED|95.0|-3.28|6.76|||Mixed Models Analysis|||Day 5, post dose||6.76|-3.28|0.492
73893539|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 20||-1.0|-1.5|<0.0001
73893540|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 24||-0.7|-1.2|<0.0001
73800112|NCT02452476|147148814|SUPERIORITY||Mean Difference (Final Values)|1.23||||0.634|TWO_SIDED|95.0|-3.9|6.36|||Mixed Models Analysis|||Day 7, post dose||6.36|-3.90|0.634
73800113|NCT02452476|147148815|SUPERIORITY|Mortality or BPD incidence at 36-week PMA was compared by treatment, using Cochran-Mantel-Haenszel (CMH), adjusting for stratification gestational age (GA) group. Relative risk (RR) and its 95% confidence interval are also provided.|Relative risk|1.03||||0.811|TWO_SIDED|95.0|0.81|1.32|||Cochran-Mantel-Haenszel|||Week 36 PMA Incidence of BPD||1.32|0.81|0.811
73800114|NCT02452476|147148815|SUPERIORITY||Relative risk|1.0||||0.972|TWO_SIDED|95.0|0.81|1.25|||Cochran-Mantel-Haenszel|||Week 36 PMA Incidence of Mortality/BPD||1.25|0.81|0.972
73800115|NCT02452476|147148815|SUPERIORITY||Relative risk|0.74||||0.619|TWO_SIDED|95.0|0.23|2.42|||Cochran-Mantel-Haenszel|||Week 36 PMA Mortality||2.42|0.23|0.619
73800116|NCT02452476|147148815|SUPERIORITY||Relative risk|1.46||||0.602|TWO_SIDED|95.0|0.35|6.09|||Cochran-Mantel-Haenszel|||Day 28 PNA Mortality||6.09|0.35|0.602
73800117|NCT02452476|147148815|SUPERIORITY||Relative risk|0.56||||0.606|TWO_SIDED|95.0|0.06|5.29|||Cochran-Mantel-Haenszel|||Day 14 PNA RDS-associated mortality in 14 days of life||5.29|0.06|0.606
73800118|NCT02452476|147148816|SUPERIORITY||Odds Ratio (OR)|0.69||||0.409|TWO_SIDED|95.0|0.3|1.57|||Fisher Exact|||||1.57|0.30|0.409
73800119|NCT02452476|147148817|SUPERIORITY|The percentage of patients requiring at least one rescue surfactant dose were compared by treatment group using the Fisher's exact test at 5% significance interval. Odds ratio (OR) and related exact 95% CI are also provided.|Odds Ratio (OR)|1.21||||0.689|TWO_SIDED|95.0|0.55|2.67|||Fisher Exact|||The percentage of patients requiring at least one rescue surfactant dose.||2.67|0.55|0.689
73800120|NCT02452476|147148818|SUPERIORITY|||||||0.935|||||||Wilcoxon (Mann-Whitney)|||||||0.935
73800121|NCT01168427|147148862|OTHER|There was no formal statistical hypothesis tested. The goal was to estimate the procedure-related complications 90 days post implant using the Kaplan-Meier method.|Rate|0.034|||||ONE_SIDED|95.0||0.1292||||||||0.1292||
73800122|NCT02654054|147148899|SUPERIORITY||Odds Ratio (OR)|56.79|||<|0.001|TWO_SIDED|95.0|23.002|140.227||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||140.227|23.002|< 0.001
73800123|NCT02654054|147148899|SUPERIORITY||Odds Ratio (OR)|22.98|||<|0.001|TWO_SIDED|95.0|10.466|50.451||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||50.451|10.466|< 0.001
73800124|NCT02654054|147148900|SUPERIORITY||LS Mean of Difference|-222.3|STANDARD_ERROR_OF_MEAN|20.77|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
73800125|NCT02654054|147148900|SUPERIORITY||LS Mean of Difference|-177.5|STANDARD_ERROR_OF_MEAN|18.24|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
73800126|NCT02654054|147148901|SUPERIORITY||Between-Group Difference (%)|79.6|||<|0.001|TWO_SIDED|95.0|71.13|88.16||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|Chi-square or Fisher's exact test|||||88.16|71.13|< 0.001
73893541|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 24||-1.0|-1.5|<0.0001
73893542|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 12||-0.5|-0.9|< 0.0001
73893543|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 12||-0.6|-1.1|< 0.0001
73893544|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 16||-0.7|-1.1|< 0.0001
73800127|NCT02654054|147148901|SUPERIORITY||Between-Group Difference (%)|52.4|||<|0.001|TWO_SIDED|95.0|44.11|60.76||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|Chi-square or Fisher's exact test|||||60.76|44.11|< 0.001
73800128|NCT02654054|147148902|SUPERIORITY||LS Mean of Difference|-234.0|STANDARD_ERROR_OF_MEAN|19.27|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73893545|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 16||-0.9|-1.4|< 0.0001
73893546|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 20||-0.7|-1.1|< 0.0001
73893547|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 20||-0.9|-1.3|< 0.0001
73893548|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 24||-0.8|-1.2|< 0.0001
73893549|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 24||-0.9|-1.4|< 0.0001
73893550|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.7|-0.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 12||-0.3|-0.7|< 0.0001
73893551|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 12||-0.4|-0.8|< 0.0001
73893552|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 16||-0.5|-0.9|< 0.0001
73893553|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 16||-0.7|-1.1|< 0.0001
73893554|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 20||-0.5|-0.9|< 0.0001
73893555|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 20||-0.5|-1.0|< 0.0001
73893556|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 24||-0.6|-1.1|< 0.0001
73893557|NCT04518995|147319726|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 24||-0.7|-1.2|< 0.0001
73800129|NCT02654054|147148902|SUPERIORITY||LS Mean of Difference|-192.5|STANDARD_ERROR_OF_MEAN|16.7|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73800130|NCT02654054|147148903|SUPERIORITY||LS Mean of Difference|-240.8|STANDARD_ERROR_OF_MEAN|21.69|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73893558|NCT04518995|147319727|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2489|TWO_SIDED|95.0|-0.2|0.9||P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||0.9|-0.2|0.2489
73800131|NCT02654054|147148903|SUPERIORITY||LS Mean of Difference|-198.2|STANDARD_ERROR_OF_MEAN|18.76|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73800132|NCT02654054|147148904|SUPERIORITY||Between-Group Difference (%)|49.7|||<|0.001|TWO_SIDED|95.0|30.27|69.18||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||69.18|30.27|< 0.001
73800133|NCT02654054|147148904|SUPERIORITY||Between-Group Difference (%)|45.4|||<|0.001|TWO_SIDED|95.0|26.9|63.92||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||63.92|26.90|< 0.001
73800134|NCT02654054|147148905|SUPERIORITY||LS Mean of Difference|-190.0|STANDARD_ERROR_OF_MEAN|22.59|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73800135|NCT02654054|147148905|SUPERIORITY||LS Mean of Difference|-116.2|STANDARD_ERROR_OF_MEAN|19.7|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
73800136|NCT00420420|147148906|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4||||0.283
73800137|NCT00420420|147148907|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at week 4||||0.180
73800138|NCT00420420|147148908|SUPERIORITY_OR_OTHER|||||||0.716||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4||||0.716
73800139|NCT00273182|147148912|SUPERIORITY_OR_OTHER||Overall survival rate at 36 month|71.0|||||TWO_SIDED|95.0|68.6|73.2||No p values for the analysis.|Kaplan-Meier (product limit) estimates|Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates.|The estimate is the overall survival rate at 36 month. left-truncation methods were used in the survival analysis for previously implanted subjects.|For overall mortality, the endpoint is the proportion of subjects alive during three years post-implant. Survival curves of overall mortality and cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals will be calculated on a log-log scale.||73.2|68.6|
73800140|NCT00273182|147148912|SUPERIORITY_OR_OTHER||Cause specific survival rate at 36 month|85.3|||||TWO_SIDED|95.0|83.3|87.1||No p value for this analysis.|Kaplan-Meier (product limit) estimates|Cause specific survival rate at 36 month.|left-truncation methods were used in the survival analysis for previously implanted subjects.|For cause-specific mortality, the endpoint is the proportion of patients who are alive or do not die due to the progressive heart failure or sudden cardiac death causes during 3 years post-implant. Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals were calculated on a log-log scale.||87.1|83.3|
73800141|NCT00273182|147148916|SUPERIORITY_OR_OTHER||event free rate|89.8|||||TWO_SIDED|95.0|88.3|91.2||No p value for this analysis.|Kaplan-Meier (product limit) estimate|||Kaplan-Meier (product limit) estimate of the curve representing the time to first post-implant LV lead related complication were calculated to the first time point where fewer than 50 patients are still at risk. Confidence intervals will be calculated on a log-log scale.||91.2|88.3|
73800142|NCT00868530|147148926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.120
73800143|NCT04199104|147148934|SUPERIORITY||point estimate|19.3||||1.9e-06|TWO_SIDED|95.0|11.2|27.3|||Miettinen and Nurminen method|||||27.3|11.2|0.0000019
73800144|NCT04199104|147148935|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0001129|TWO_SIDED|95.0|0.55|0.83|||Regression, Cox|||||0.83|0.55|0.0001129
73800145|NCT04199104|147148936|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.8819584|TWO_SIDED|95.0|0.91|1.45|||Regression, Cox|||||1.45|0.91|0.8819584
73800146|NCT05120193|147148940|NON_INFERIORITY|The primary safety analysis is performed at a one-sided Type I error rate of α = 0.05. The Farrington-Manning method is used to calculate the upper 95% confidence bound for the difference (QI - QC) between the rate of the primary safety endpoint in the investigational arm (QI) and the rate of the primary safety endpoint in the control arm (QC). If the upper confidence bound is less than 0.08, the study is considered to have demonstrated safety of the investigational device.|Risk Difference (RD)|0.005|||<|0.0001|TWO_SIDED|90.0|-0.028|0.037|||Farrington-Manning|||"The null hypothesis (H0) for the primary safety analysis is that the true rate of primary safety events for the investigational device (QI) is equal to or greater than the true rate for the control device (QC) plus a non-inferiority margin (NIM) of 0.08. The alternative hypothesis (HA) is that the rate of primary safety events for the investigational arm (QI) is less than the rate of primary safety events for the control arm (QC) plus the NIM of 0.08.~H0: QI ≥ QC + 0.08 HA: QI \< QC + 0.08"||0.037|-0.028|<0.0001
73893559|NCT04518995|147319727|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.32||0.1235|TWO_SIDED|95.0|-0.1|1.1||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||1.1|-0.1|0.1235
73893560|NCT04518995|147319727|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9765|TWO_SIDED|95.0|-0.5|0.5||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||0.5|-0.5|0.9765
73893561|NCT04518995|147319727|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.3559|TWO_SIDED|95.0|-0.3|0.8||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||0.8|-0.3|0.3559
73893562|NCT04518995|147319728|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.16|0.25||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.25|0.16|<0.0001
73893563|NCT04518995|147319728|SUPERIORITY||Risk Difference (RD)|0.33|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.27|0.39||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.39|0.27|<0.0001
73893564|NCT02891070|147319745|NON_INFERIORITY|To demonstrate non-inferiority (NI) of Tisseel to DuraSeal for the primary endpoint, the lower limit of the 95% CI (based on normal approximation) for the difference in average predicted proportions had to be greater than -10%.|Mean Difference (Net)|-9.29|||||TWO_SIDED|95.0|-21.11|2.54|||Regression, Logistic||Difference in Average Predicted Proportion (Tisseel - Duraseal)|||2.54|-21.11|
73893565|NCT02891070|147319747|OTHER||Mean Difference (Net)|-9.29|||||TWO_SIDED|95.0|-21.11|2.54|||Regression, Logistic||Difference in Average Predicted Proportion (Tisseel - Duraseal)|||2.54|-21.11|
73800147|NCT05120193|147148941|NON_INFERIORITY|The primary effectiveness analysis (PSE) is performed at a one-sided Type I error rate of α = 0.025. The Farrington-Manning method is used to calculate the lower 97.5% confidence bound for the difference (PI - PC) between the rate of the PSE in the investigational arm (PI) and the rate of the PSE in the control arm (PC). If the lower confidence bound is greater than -0.15, the study is considered to have demonstrated effectiveness of the investigational device.|Risk Difference (RD)|0.08||||0.025|TWO_SIDED|95.0|-0.009|0.168|||Farrington-Manning|||"The null hypothesis (H0) is that the true rate of primary effectiveness endpoint success (no failures through Day 360) for the investigational device (PI) is less than or equal to the true rate for the control device (PC) minus the NIM of 0.15. The alternative hypothesis (HA) is that the success rate for the investigational arm (PI) is greater than the success rate for the control device (PC) minus the NIM of 0.15.~H0: PI ≤ PC - 0.15 HA: PI \> PC - 0.15"||0.168|-0.009|0.025
73800148|NCT05120193|147148942|SUPERIORITY||Mean Difference (Final Values)|-29.2|||<|0.0001|TWO_SIDED|95.0|-31.7|-26.8|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean total energy application time during the ablation procedure for the investigational device (ETI) is greater than or equal to the mean time for the control device (ETC). The alternative hypothesis (HA) is that the mean total energy application time for the investigational device is less.~H0: ETI ≥ ETC versus HA: ETI \< ETC"||-26.8|-31.7|<0.0001
73800149|NCT05120193|147148943|SUPERIORITY||Mean Difference (Final Values)|-26.8|||<|0.0001|TWO_SIDED|95.0|-32.2|-21.4|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean treatment time for the investigational device (TTI) is greater than or equal to the mean treatment time for the control device (TTC). The alternative hypothesis (HA) is that the mean treatment time for the investigational device is less.~H0: TTI ≥ TTC versus HA: TTI \< TTC"||-21.4|-32.2|<0.0001
73800150|NCT05120193|147148944|SUPERIORITY||Mean Difference (Final Values)|-25.1||||0.025|TWO_SIDED|95.0|-33.0|-17.3|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean procedure time for the investigational device (PTI) is greater than or equal to the mean procedure time for the control device (PTC). The alternative hypothesis (HA) is that the mean procedure time for the investigational device is less.~H0: PTI ≥ PTC versus HA: PTI \< PTC"||-17.3|-33.0|0.025
73800151|NCT05411991|147149001|SUPERIORITY||Net treatment benefit|10.5||||0.357|TWO_SIDED|95.0|-11.9|31.9|||General pairwaise comparison|||||31.9|-11.9|0.357
73800152|NCT02059512|147149017|SUPERIORITY|||||||0.24|||||||Kruskal-Wallis|||||||0.24
73800153|NCT02059512|147149018|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||Length of hospital stay.||||0.1
73800154|NCT02059512|147149018|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||Length of stay in the intensive care unit.||||0.1
73800155|NCT02059512|147149019|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||||||0.4
73800156|NCT02059512|147149019|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Analysis of leukocytes 0-6 hours of the postoperative period.||||0.8
73893566|NCT02891070|147319748|OTHER|||||||0.0241|||||||Wilcoxon (Mann-Whitney)|||||||0.0241
73800157|NCT02059512|147149019|SUPERIORITY|||||||0.9|||||||Kruskal-Wallis|||Analysis of leukocytes 12-18 hours of the postoperative period.||||0.9
73800158|NCT02059512|147149019|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||Analysis of leukocytes 18-24 hours of the postoperative period.||||0.2
73800159|NCT02059512|147149019|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||Analysis of leukocytes 48 hours of the postoperative period.||||0.5
73800160|NCT02059512|147149019|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Analysis of leukocytes 72 hours of the postoperative period.||||0.4
73800161|NCT02059512|147149019|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Analysis of leukocytes 96 hours of the postoperative period/||||0.6
73800162|NCT02059512|147149019|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Analysis of leukocytes 7 days of the postoperative period.||||0.4
73800163|NCT02059512|147149019|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||Analysis of leukocytes 14 days of the postoperative period.||||0.5
73800164|NCT02059512|147149020|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||CRP initially.||||0.1
73893567|NCT02891070|147319749|OTHER|||||||0.1015|||||||Wilcoxon (Mann-Whitney)|||||||0.1015
73893568|NCT02891070|147319750|OTHER|||||||0.9943|||||||Wilcoxon (Mann-Whitney)|||||||0.9943
73893569|NCT02891070|147319751|OTHER||Mean Difference (Net)|-5.11|||||TWO_SIDED|95.0|-13.6|3.39|||Regression, Logistic|||||3.39|-13.60|
73893570|NCT04491604|147319756|EQUIVALENCE|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data.|responder rate difference|45.8||||0.00192|TWO_SIDED|95.0|23.6|68.0|||McNemar|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. A multiple imputation approach was used for missing data.|The difference is the treatment/discordance difference in percentage of responders (primary wounds with complete healing), which is the same as the difference in the percentage of treatment responders and the percentage of placebo responders.|The null hypothesis of interest was the absence of a treatment effect on wound healing and the alternative hypothesis is the presence of a treatment effect on wound healing. The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. For subjects with missing primary wound healing data, a multiple imputation approach was used.||68.0|23.6|0.00192
73800165|NCT02059512|147149020|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||CRP postoperative 4-6 days.||||0.4
73800166|NCT02059512|147149020|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||CRP postoperative 12-14 days.||||0.99
73800167|NCT02059512|147149021|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||The volume of discharge through the drains on the first day after surgery.||||0.2
73800168|NCT02059512|147149021|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||The volume of discharge through the drains on the second day after the operation.||||0.3
73800169|NCT02059512|147149022|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Troponin I postoperative day 1.||||0.6
73800170|NCT02059512|147149022|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Troponin I postoperative day 3.||||0.4
73800171|NCT02059512|147149022|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Myoglobin postoperative day 1.||||0.8
73800172|NCT02059512|147149022|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||Myoglobin postoperative day 3.||||0.7
73800173|NCT02059512|147149023|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||CPK-MB postoperative day 1.||||0.7
73800174|NCT02059512|147149023|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||CPK-MB postoperative day 3.||||0.8
73800175|NCT02059512|147149024|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||Hb intraoperatively before turning off the cardiopulmonary bypass(CPB).||||1.0
73800176|NCT02059512|147149024|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Hb at the end of the operation.||||0.4
73800177|NCT02059512|147149025|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||HCT intraoperatively before turning off the cardiopulmonary bypass (CPB).||||0.8
73800178|NCT02059512|147149025|SUPERIORITY|||||||0.3|||||||Kruskal-Wallis|||HCT at the end of the operation.||||0.3
73800179|NCT02059512|147149026|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||K+ intraoperatively before turning off the cardiopulmonary bypass (CPB).||||0.4
73800180|NCT02059512|147149026|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||K+ at the end of the operation.||||0.1
73800181|NCT02059512|147149027|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
73800182|NCT02059512|147149028|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
73800183|NCT02059512|147149029|SUPERIORITY|||||||0.6|||||||Chi-squared|||Hydrothorax / postoperative period.||||0.6
73800184|NCT02059512|147149029|SUPERIORITY|||||||0.2|||||||Chi-squared|||Hydropericardium / postoperative period.||||0.2
73800185|NCT02059512|147149029|SUPERIORITY|||||||0.6|||||||Chi-squared|||Resternotomy / postoperative period.||||0.6
73800186|NCT02059512|147149029|SUPERIORITY|||||||0.06|||||||Chi-squared|||Atrial fibrillation / postoperative period.||||0.06
73800187|NCT02059512|147149029|SUPERIORITY|||||||0.06|||||||Chi-squared|||Atrial flutter / postoperative period.||||0.06
73800188|NCT02059512|147149030|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||||||0.4
73800189|NCT02059512|147149031|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Lvd ind. (Lvd mm./BSA kg / cm) - Evaluation of the left ventricular end-diastolic size index.||||0.5
73800190|NCT02059512|147149031|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Lvs ind. (Lvs mm./BSA kg / cm) - Evaluation of the left ventricular end-systolic size index.||||0.5
73800191|NCT02059512|147149031|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||LAind. (LA mm./BSA kg / cm) - Left Atrial Size Index Assessment.||||0.6
73800192|NCT02059512|147149032|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - Evaluation of the left ventricular end-diastolic volume index.||||0.4
73800193|NCT02059512|147149032|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||Evaluation of the left ventricular end-systolic volume index (LVESV MOD BP ind.)||||0.3
73800194|NCT02059512|147149033|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
73800195|NCT02059512|147149035|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Physical Functioning SF-36. Comparison of patients of group 1 and group 2 with the control group - group 0.||||0.7
73800196|NCT02059512|147149035|SUPERIORITY|||||||0.8|||||||RepeatedMeasures ANOVA|||Role-Physical Functioning SF-36||||0.8
73800197|NCT02059512|147149035|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Bodily pain SF-36||||0.7
73800198|NCT02059512|147149035|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||General Health SF-36.||||0.6
73800199|NCT02059512|147149035|SUPERIORITY|||||||0.8|||||||RepeatedMeasures ANOVA|||Vitality SF-36.||||0.8
73800200|NCT02059512|147149035|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Social Functioning SF-36.||||0.7
73800201|NCT02059512|147149035|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Role- Emotional SF-36.||||0.7
73800202|NCT02059512|147149035|SUPERIORITY|||||||0.96|||||||RepeatedMeasures ANOVA|||Mental Health SF-36.||||0.96
73800203|NCT02059512|147149035|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Minnesota Quality of Life (MHFLQ).||||0.7
73800204|NCT02059512|147149035|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||Seattle QuestionnairePhysical limitation.||||0.6
73800205|NCT02059512|147149035|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireAngina stability.||||0.4
73800206|NCT02059512|147149035|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireAngina frequency.||||0.6
73800207|NCT02059512|147149035|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireTreatment satisfaction.||||0.7
73800208|NCT02059512|147149035|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaire Disease perception.||||0.3
73800209|NCT02059512|147149036|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
73800210|NCT02059512|147149037|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
73800211|NCT02059512|147149038|SUPERIORITY|||||||0.35|||||||RepeatedMeasures ANOVA|||||||0.35
73800212|NCT02059512|147149039|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||Lvd ind. (Lvd mm./BSA) - left ventricular end-diastolic size index. All patients included in the study.||||0.2
73800213|NCT02059512|147149039|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||Lvs ind. (Lvs mm./BSA kg / cm) - left ventricular end-systolic size index.||||0.2
73800214|NCT02059512|147149039|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||LAind. (LA mm./BSA kg / cm) - left atrial index.||||0.5
73800215|NCT02059512|147149040|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - left ventricular end-diastolic volume index.||||0.6
73800216|NCT02059512|147149040|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||LVESV MOD BP ind. (LVESV MOD BP ml./BSA kg / cm) - left ventricular end-systolic volume index.||||0.2
73893571|NCT04491604|147319757|EQUIVALENCE|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data.|responder rate difference|51.0||||0.00047|TWO_SIDED|95.0|29.3|72.6||There is no multiplicity adjustment needed since the hypothesis testing are hierarchical.|McNemar|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. A multiple imputation approach was used for missing data.|The difference is the treatment/discordance difference in percentage of responders (complete wound healing), which is the same as the difference in the percentage of treatment responders and the percentage of placebo responders.|The null hypothesis of interest was the absence of a treatment effect on wound healing and the alternative hypothesis is the presence of a treatment effect on wound healing. The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. For subjects with missing primary wound healing data, a multiple imputation approach was used.||72.6|29.3|0.00047
73893572|NCT04335136|147319806|OTHER|||||||0.5207||||||The level of significance was 5% (2-sided).|Chi-squared|||"Hypothesis tested: H0: pAPN01 = pPlacebo; H1: pAPN01 ≠ pPlacebo (with p=proportion of patients with event).~A total of 186 patients (93 per group) was estimated to yield 80% power to detect a 20% absolute risk reduction in the primary, from 50% in the placebo group to 30% in the APN01 group, at a 2-sided alpha of 0.05. To consider patients who would be randomized but not treated, a total of 200 patients (100 per group) were planned to be enrolled."||||0.5207
73800217|NCT02059512|147149041|SUPERIORITY|||||||0.35|||||||RepeatedMeasures ANOVA|||Peak E of transmitral flow||||0.35
73800218|NCT02059512|147149041|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Peak A of transmitral flow.||||0.7
73800219|NCT02059512|147149042|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Peak E of transmitral flow/ Peak A of transmitral flow (E/A).||||0.5
73800220|NCT02059512|147149043|SUPERIORITY|||||||0.9|||||||RepeatedMeasures ANOVA|||DT (Half-time of wave E).||||0.9
73800221|NCT02059512|147149043|SUPERIORITY|||||||0.9|||||||RepeatedMeasures ANOVA|||time of isovolumic relaxation of the left ventricle||||0.9
73800222|NCT02059512|147149044|SUPERIORITY|||||||0.0367|||||||Kruskal-Wallis|||||||0.0367
73800223|NCT02059512|147149045|SUPERIORITY|||||||0.04|||||||Chi-squared|||Assessment of the functioning of grafts. Patency of grafts within a specified time of treatment (angiography).||||0.04
73800224|NCT02059512|147149046|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
73800225|NCT02059512|147149047|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|||||||0.05
73800226|NCT02059512|147149048|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|Data were analyzed by 1, 2, and 3 sections according to the study design.||Mononuclear fraction %||||0.05
73800227|NCT02059512|147149048|SUPERIORITY|||||||0.057|||||||Discriminant Analysis|Data were analyzed by 1, 2, and 3 sections according to the study design.||CD34+ %||||0.057
73800228|NCT02059512|147149048|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|||CD133+ %||||0.05
73800229|NCT02059512|147149049|SUPERIORITY|||||||0.046|||||||Factor analysis|||Factor analysis - determining the influence of a factor, in this case, smoking, on the deficit in the number of meters passed according to the test with a 6-minute walk.||||0.046
73800230|NCT03848715|147149072|SUPERIORITY|||||||0.16|||||||Regression, Linear|||||||.16
73800231|NCT02157935|147149106|SUPERIORITY_OR_OTHER||Rate ratio|0.76||||0.0059|TWO_SIDED|95.0|0.62|0.92|||Negative binomial model|||||0.92|0.62|0.0059
73800232|NCT02157935|147149107|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0164|TWO_SIDED|95.0|0.64|0.96|||Regression, Cox|||||0.96|0.64|0.0164
73800233|NCT02157935|147149108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.343||||0.007|TWO_SIDED|95.0|-2.318|-0.368|||Mixed Models Analysis|||||-0.368|-2.318|0.0070
73800234|NCT02157935|147149109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.0091|TWO_SIDED|95.0|0.008|0.053|||Mixed Models Analysis|||||0.053|0.008|0.0091
73800235|NCT02157935|147149110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.203||||0.0082|TWO_SIDED|95.0|-0.353|-0.053|||ANCOVA|||||-0.053|-0.353|0.0082
73800236|NCT02157935|147149111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028||||0.0048|TWO_SIDED|95.0|-0.048|-0.009|||ANCOVA|||||-0.009|-0.048|0.0048
73800237|NCT00572936|147149112|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for significance was \<0.05|ANOVA|||||||<.05
73800238|NCT00572936|147149113|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was \<0.05|ANOVA|||||||<0.05
73800239|NCT00572936|147149114|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.93||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.93
73800240|NCT00572936|147149115|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.84||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.84
73800241|NCT00572936|147149116|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was \<0.05|ANOVA|||||||<0.05
73800242|NCT00572936|147149117|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.89||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.89
73800243|NCT00572936|147149118|EQUIVALENCE|Kruskal-Wallis test was used to compare the differences between outflow facility for the three interventions|||||<|0.05||||||threshold for statistical significance was \<0.05|Kruskal-Wallis|||||||<0.05
73800244|NCT00572936|147149119|EQUIVALENCE|Kruskal-Wallis test was used to compare the differences in uveoscleral outflow between the three interventions|||||<|0.05||||||threshold for statistical analysis was \<0.05|Kruskal-Wallis|||||||<0.05
73800245|NCT02493660|147149126|NON_INFERIORITY|The non-inferiority margin was 10% for all composite endpoints. The primary analysis method was a multilinear regression model for month 12 success with age (\<65 years, ≥65 years), gender, and treatment as the model covariates for the PP population for noninferiority testing.||||||0.0049|||||||Regression, Logistic|Primary analysis method was for month 12 success with age (\<65 years, ≥65 years), sex, and treatment as the model covariates.||||||0.0049
73800246|NCT02493660|147149129|NON_INFERIORITY|The non-inferiority margin was 10% for all composite endpoints.|||||<|0.05|||||||Regression, Logistic|||Results from logistic regression model.||||<0.05
73800247|NCT02502149|147149172|OTHER||Adjusted Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.24|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).|||1.24|0.93|
73800248|NCT02502149|147149173|OTHER||Adjusted Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.87|1.16|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).|||1.16|0.87|
73893573|NCT04335136|147319806|OTHER||Odds Ratio (OR)|0.63||||0.3588|TWO_SIDED|95.0|0.23|1.7|||Regression, Logistic|Degree of freedom: 1||||1.70|0.23|0.3588
73893574|NCT02834793|147319823|SUPERIORITY||Median Difference (Net)|-19.3|||=|0.107|TWO_SIDED|95.0|-49.2|4.8||The p-value was based on a rank analysis of covariance (ANCOVA) with treatment, region, and age-group as factors, and prerandomization drop seizure frequency as a covariate.|ANCOVA||The median difference to placebo and the 95 percent (%) confidence interval (CI) were based on the Hodges-Lehmann method.|||4.8|-49.2|= 0.107
73893575|NCT02136069|147319848|SUPERIORITY||Adjusted Difference in Remission Rates|-0.9||||0.8114||95.0|-8.7|6.83|||Cochran-Mantel-Haenszel|||||6.83|-8.70|0.8114
73893576|NCT02136069|147319849|NON_INFERIORITY|with margin -12.5%|Adjusted Difference in Remission Rates|-12.0||||0.1293|TWO_SIDED|95.0|-20.5|-3.26||p-values are not multiplicity adjusted|Cochran-Mantel-Haenszel|A Farrington-Manning non-inferiority test was used to determine the nominal p-value.||||-3.26|-20.50|0.1293
73893577|NCT02136069|147319850|SUPERIORITY||Adjusted Difference in Remission Rates|-3.4||||0.4056|TWO_SIDED|95.0|-11.53|4.74||p-values are not multiplicity adjusted|Cochran-Mantel-Haenszel|||||4.74|-11.53|0.4056
73893578|NCT02136069|147319851|SUPERIORITY||Adjusted Difference in Remission Rates|-2.4||||0.4591|TWO_SIDED|95.0|-8.88|4.14||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||4.14|-8.88|0.4591
73893579|NCT02136069|147319852|SUPERIORITY||Adjusted Difference in Remission Rates|5.3||||0.4196|TWO_SIDED|95.0|-7.54|18.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||18.13|-7.54|0.4196
73893580|NCT02136069|147319853|SUPERIORITY||Adjusted Difference in Response Rates|-12.4||||0.0118|TWO_SIDED|95.0|-21.84|-2.66||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-2.66|-21.84|0.0118
73893581|NCT02136069|147319854|SUPERIORITY||Adjusted Difference in Response Rates|-4.9||||0.2845|TWO_SIDED|95.0|-13.76|4.12||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||4.12|-13.76|0.2845
73893582|NCT02136069|147319855|SUPERIORITY||Adjusted Difference in Response Rates|-6.3||||0.1234|TWO_SIDED|95.0|-14.3|1.84||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||1.84|-14.30|0.1234
73893583|NCT02136069|147319856|SUPERIORITY||Adjusted Difference in Remission Rates|-5.0||||0.2168|TWO_SIDED|95.0|-12.84|2.94||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||2.94|-12.84|0.2168
73893584|NCT02136069|147319857|SUPERIORITY||Adjusted Difference in Response Rates|-9.5||||0.0564|TWO_SIDED|95.0|-19.06|0.29||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||0.29|-19.06|0.0564
73893585|NCT02136069|147319858|SUPERIORITY||Adjusted Difference in Response Rates|-6.0||||0.1729|TWO_SIDED|95.0|-14.51|2.7||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||2.70|-14.51|0.1729
73893586|NCT02136069|147319859|SUPERIORITY||Adjusted Difference in Remission Rates|-0.8||||0.8941|TWO_SIDED|95.0|-12.01|10.68||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||10.68|-12.01|0.8941
73893587|NCT02136069|147319868|SUPERIORITY|Week 10|Difference in Adjusted Means|-3.1||||0.4106|TWO_SIDED|95.0|-10.6|4.3||p-value has not been adjusted for multiplicity|ANCOVA|||||4.3|-10.6|0.4106
73893588|NCT02136069|147319868|SUPERIORITY|Week 30|Difference in Adjusted Means|-5.7||||0.1434|TWO_SIDED|95.0|-13.3|1.9||p-value has not been adjusted for multiplicity|ANCOVA|||||1.9|-13.3|0.1434
73893589|NCT02136069|147319868|SUPERIORITY|Week 54|Difference in Adjusted Means|-6.1||||0.1103|TWO_SIDED|95.0|-13.6|1.4||p-value has not been adjusted for multiplicity|ANCOVA|||||1.4|-13.6|0.1103
73893590|NCT00622440|147319878|OTHER||Wilcoxon Rank Sum Effect Size|0.275||||0.042|TWO_SIDED|95.0|||||Wilcoxon rank sum||The wilcoxon rank sum effect size ranges in strength of effect from small (0.10 - \< 0.30), to medium (0.30 - \< 0.50), to large (\>=0.50) with a total range of 0 to 1|Estimated Effect Size for Phase 3 Trial||||.042
73893591|NCT03328208|147319885|SUPERIORITY||Mean Difference (Final Values)|0.724|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73893592|NCT03328208|147319886|SUPERIORITY||Mean Difference (Final Values)|0.038|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73893593|NCT01667419|147319896|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.001|TWO_SIDED|95.0|0.37|0.78|||Log Rank|||||0.78|0.37|0.0010
73893594|NCT01667419|147319896|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.2598|TWO_SIDED|95.0|0.54|1.18|||Log Rank|||||1.18|0.54|0.2598
73893595|NCT01667419|147319897|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0133|TWO_SIDED|95.0|0.37|0.9|||Log Rank|||||0.90|0.37|0.0133
73893596|NCT01667419|147319897|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.6815|TWO_SIDED|95.0|0.57|1.44|||Log Rank|||||1.44|0.57|0.6815
73893597|NCT01667419|147319898|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0274|TWO_SIDED|95.0|0.3|0.94|||Log Rank|||||.94|0.30|0.0274
73893598|NCT01667419|147319898|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8597|TWO_SIDED|95.0|0.55|1.66|||Log Rank|||||1.66|0.55|0.8597
73893599|NCT06026124|147319928|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73893600|NCT06026124|147319928|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73893601|NCT06026124|147319929|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73893602|NCT06026124|147319929|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73893603|NCT06026124|147319930|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73893604|NCT06026124|147319930|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73893605|NCT06026124|147319931|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
73893606|NCT06026124|147319931|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73893607|NCT06026124|147319932|SUPERIORITY||||||=|0.17|||||||LSD test|||||||=0.17
73893608|NCT06026124|147319932|SUPERIORITY||||||=|1|||||||LSD test|||||||=1.00
73893609|NCT06026124|147319933|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
73893610|NCT06026124|147319934|SUPERIORITY||||||=|0.51|||||||LSD test|||||||=0.51
73893611|NCT03023813|147319938|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.50
73893612|NCT03023813|147319939|OTHER|||||||0.25|||||||t-test, 2 sided|||||||.25
73893613|NCT03023813|147319940|OTHER|||||||0.39|||||||t-test, 2 sided|||||||.39
73893614|NCT03023813|147319941|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
73893615|NCT03023813|147319942|OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
73893616|NCT03023813|147319943|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
73893617|NCT03023813|147319944|OTHER|Percent change in weight (lbs.) since the baseline encounter|Mean Difference (Net)|-2.96||||0.27|TWO_SIDED|95.0|-8.18|2.26|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included weight loss||2.26|-8.18|0.27
73893618|NCT03023813|147319944|OTHER|Change in systolic blood pressure since the baseline encounter (mmHg)|Mean Difference (Net)|-6.42||||0.19|TWO_SIDED|95.0|-16.12|3.27|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included blood pressure control||3.27|-16.12|0.19
73893619|NCT03023813|147319944|OTHER|Percentage point change in HbA1c (%) since the baseline encounter|Mean Difference (Net)|-0.68||||0.24|TWO_SIDED|95.0|-1.82|0.45|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included glycemic control||0.45|-1.82|0.24
73893620|NCT03023813|147319944|OTHER|Percentage point change in 10-year atherosclerotic cardiovascular disease risk (%), as estimated by the American College of Cardiology Pooled Cohort Equations, since the baseline encounter|Mean Difference (Net)|-1.2||||0.34|TWO_SIDED|95.0|-3.65|1.26|||Generalized linear mixed regression||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included lipids control||1.26|-3.65|0.34
73893621|NCT03023813|147319944|OTHER|Change in low-density lipoprotein (LDL) cholesterol (mg/dL) since the baseline encounter|Mean Difference (Net)|-8.46||||0.36|TWO_SIDED|95.0|-26.63|9.7|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included lipids control||9.70|-26.63|0.36
73893622|NCT03023813|147319944|OTHER|Change in smoking intensity (defined as a change in smoking status from Current Every Day to either Current Some Days or Quit; or from Current Some Days to Quit) since the baseline encounter.|Odds Ratio (OR)|1.2||||0.92|TWO_SIDED|95.0|0.03|45.56|||Mixed Models Analysis|Generalized linear mixed regression with logit link|Result for intervention arm relative to control arm. OR \<1 indicates reduction in smoking intensity; OR \>1 indicates increase in smoking intensity.|Among participants whose individualized preventive care recommendations included tobacco cessation||45.56|0.03|0.92
73893623|NCT03023813|147319944|OTHER|Receipt of colorectal cancer screening since the baseline encounter|Odds Ratio (OR)|2.52||||0.99|TWO_SIDED|95.0|0.001|1000.0|||Mixed Models Analysis|Generalized linear mixed regression with logit link|Result for intervention arm relative to control arm. Lower limit estimate was \<0.001 and upper limit estimate was \>1000 (ClinicalTrials.gov does not allow \< or \> to be entered into the confidence interval lower limit or upper limit fields).|Among participants whose individualized preventive care recommendations included colorectal cancer screening||1000|0.001|0.99
73893624|NCT00329797|147319954|SUPERIORITY|||||||0.95|||||||Log Rank|||The study is designed to show a 40% relative reduction in the yearly ABF hazard rate, equivalent to an improvement in a 3-year FABF rate from 88% to 92.6%. A sample size of 1030 analyzable patients with a one-sided log-rank test at α = 0.05, was calculated to provide 80% statistical power, with one interim analysis and a final analysis for efficacy using Haybittle-Peto boundaries.||||0.95
73893625|NCT00329797|147319955|SUPERIORITY||||||<|0.0001||||||significance level = 0.05|t-test, 2 sided|||Lumbar||||<0.0001
73893626|NCT00329797|147319955|SUPERIORITY|||||||0.47||||||significance level = 0.05|t-test, 2 sided|||Hip - right||||0.47
73893627|NCT00329797|147319955|SUPERIORITY|||||||0.0002||||||significance level = 0.05|t-test, 2 sided|||Hip - left||||0.0002
73800249|NCT02222922|147149278|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|79.38||||0.3105|TWO_SIDED|90.0|54.01|116.65|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||116.65|54.01|0.3105
73893628|NCT00329797|147319955|SUPERIORITY|||||||0.076||||||significance level = 0.05|t-test, 2 sided|||Femoral - right||||0.076
73893629|NCT00329797|147319955|SUPERIORITY|||||||0.0007||||||significance level = 0.05|t-test, 2 sided|||Femoral - left||||0.0007
73893630|NCT00329797|147319956|SUPERIORITY|||||||0.33||||||significance level = 0.01|t-test, 2 sided|||Physical subscale||||0.33
73800250|NCT02222922|147149279|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|77.23||||0.2316|TWO_SIDED|90.0|53.8|110.87|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||110.87|53.80|0.2316
73800251|NCT02222922|147149280|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|84.97||||0.4264|TWO_SIDED|90.0|60.05|120.22|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||120.22|60.05|0.4264
73800252|NCT02222922|147149281|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|88.32||||0.5123|TWO_SIDED|90.0|64.03|121.82|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||121.82|64.03|0.5123
73893631|NCT00329797|147319956|SUPERIORITY|||||||0.82||||||significance level = 0.01|t-test, 2 sided|||Social subscale||||0.82
73893632|NCT00329797|147319956|SUPERIORITY|||||||0.51||||||significance level = 0.01|t-test, 2 sided|||Emotional subscale||||0.51
73893633|NCT00329797|147319956|SUPERIORITY|||||||0.25||||||significance level = 0.01|t-test, 2 sided|||Functional subscale||||0.25
73893634|NCT00329797|147319956|SUPERIORITY|||||||0.63||||||significance level = 0.01|t-test, 2 sided|||Total||||0.63
73893635|NCT02695420|147320044|SUPERIORITY||Treatment Difference|22.1|STANDARD_ERROR_OF_MEAN|6.3||0.0008|TWO_SIDED|95.0|9.6|34.7|||Repeated Measures Model|||||34.7|9.6|0.0008
73893636|NCT02695420|147320044|SUPERIORITY||Treatment Difference|29.3|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|16.3|42.3|||Repeated measures model|||||42.3|16.3|< 0.0001
73893637|NCT02695420|147320044|SUPERIORITY||Treatment Difference|25.5|STANDARD_ERROR_OF_MEAN|6.5||0.0002|TWO_SIDED|95.0|12.6|38.4|||Repeated measures model|||||38.4|12.6|0.0002
73893638|NCT00916929|147320047|SUPERIORITY_OR_OTHER||rate per patient year of follow up|1.5||||||95.0|||||exact method|95% Upper Confidence Limit of objective performance criteria||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Expected False Positive Rate ≥1.5 per patient-year of follow-up Ha: Expected False Positive Rate \<1.5 per patient-year of follow-up~The null hypothesis is rejected at the 5% significance level if the 95% upper confidence limit (UCL) for expected FPR is less than 1.5 per patient-year of follow-up."||||
73893639|NCT00916929|147320048|SUPERIORITY_OR_OTHER||sensitivity|50.0|STANDARD_ERROR_OF_MEAN|5.0|||ONE_SIDED|95.0|50.0||||exact method|||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Sensitivity ≤ 50% Ha: Sensitivity \> 50%~The desired outcome was to reject the null hypothesis at the 5% significance level. The null hypothesis is rejected at the 5% significance level if the 95% lower confidence limit (LCL) for sensitivity is greater than 50%."|||50|
73893640|NCT01742286|147320055|OTHER||MTD/RDE|510.0||||||||||||||||||
73893641|NCT01742286|147320055|OTHER||MTD/RDE|500.0||||||||||||||||||
73893642|NCT04530136|147320071|SUPERIORITY|||||||0.0346|||||||Wilcoxon rank test|||||||0.0346
73893643|NCT04530136|147320072|SUPERIORITY|||||||0.4441|||||||WHO Ordinal Scale|||||||0.4441
73893644|NCT04530136|147320073|SUPERIORITY|||||||0.1021|||||||WHO Ordinal Scale for Clin Improvement|||||||0.1021
73893645|NCT04530136|147320074|SUPERIORITY|||||||0.1615|||||||WHO Ordinal Scale|||||||0.1615
73893646|NCT01387542|147320079|SUPERIORITY_OR_OTHER|||||||0|||||||Friedman test|||||||0.000
73893647|NCT01387542|147320080|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t-test|||||||0.009
73800253|NCT02222922|147149282|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|91.15||||0.824|TWO_SIDED|90.0|44.79|185.5|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||185.50|44.79|0.8240
73893648|NCT01387542|147320081|SUPERIORITY_OR_OTHER|||||||0.001|||||||Paired t-test|||||||0.001
73893649|NCT01387542|147320082|SUPERIORITY_OR_OTHER|||||||0|||||||Paired t-test|||||||0.000
73893650|NCT03601117|147320087|OTHER|This is to test for the antidepressant effect of LDLPFC stimulation. Test is change in score from baseline to approximately 48 hours after the final session.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
73893651|NCT02762370|147320134|SUPERIORITY|||||||0.0452|||||||t-test, 2 sided|||||||0.0452
73893652|NCT01708902|147320183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.0587|TWO_SIDED|95.0|-0.45|0.01|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||0.01|-0.45|0.0587
73800254|NCT02222922|147149283|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|89.58||||0.7922|TWO_SIDED|90.0|43.94|182.62|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||182.62|43.94|0.7922
73800255|NCT02222922|147149284|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|91.17||||0.824|TWO_SIDED|90.0|44.87|185.25|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||185.25|44.87|0.8240
73800256|NCT02222922|147149285|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|102.31||||0.9553|TWO_SIDED|90.0|51.08|204.9|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||204.90|51.08|0.9553
73893653|NCT01708902|147320183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.23|-0.78|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.78|-1.23|<0.0001
73893654|NCT01708902|147320183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.73|-0.29|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.29|-0.73|<0.0001
73893655|NCT01708902|147320183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.09|-0.64|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.64|-1.09|<0.0001
73893656|NCT01708902|147320184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.673|STANDARD_ERROR_OF_MEAN|0.487||0.0771|TWO_SIDED|95.0|0.946|2.961|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.961|0.946|0.0771
73893657|NCT01708902|147320184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.489|STANDARD_ERROR_OF_MEAN|1.543|<|0.0001|TWO_SIDED|95.0|3.164|9.522|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||9.522|3.164|<0.0001
73893658|NCT01708902|147320184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.829|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|1.678|4.767|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||4.767|1.678|<0.0001
73893659|NCT01708902|147320184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.818|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|2.259|6.454|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||6.454|2.259|<0.0001
73800257|NCT02222922|147149286|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|81.14||||0.2951|TWO_SIDED|90.0|57.99|113.54|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||113.54|57.99|0.2951
73800258|NCT02222922|147149287|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|84.02||||0.3769|TWO_SIDED|90.0|60.24|117.19|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||117.19|60.24|0.3769
73800259|NCT02222922|147149288|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|86.15||||0.4385|TWO_SIDED|90.0|62.2|119.32|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||119.32|62.20|0.4385
73800260|NCT02222922|147149289|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|88.75||||0.5678|TWO_SIDED|90.0|62.24|126.56|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||126.56|62.24|0.5678
73800261|NCT03207776|147149370|SUPERIORITY||Odds Ratio (OR)|0.8||||0.041|TWO_SIDED|95.0|0.64|0.99|||Mixed Models Analysis|||||0.99|0.64|0.041
73800262|NCT03207776|147149371|SUPERIORITY||Odds Ratio (OR)|0.99||||0.952|TWO_SIDED|95.0|0.69|1.42|||Mixed Models Analysis|||||1.42|0.69|0.952
73800263|NCT03207776|147149372|SUPERIORITY||Odds Ratio (OR)|0.91||||0.472|TWO_SIDED|95.0|0.71|1.17|||Mixed Models Analysis|||||1.17|0.71|0.472
73800264|NCT03207776|147149373|SUPERIORITY||Odds Ratio (OR)|1.14||||0.544|TWO_SIDED|95.0|0.74|1.77|||Mixed Models Analysis|||||1.77|0.74|0.544
73800265|NCT00116779|147149374|SUPERIORITY_OR_OTHER||Percentage of participants|86.0||||||95.0|73.0|94.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||94|73|
73800266|NCT00116779|147149374|SUPERIORITY_OR_OTHER||Percentage of participants|77.0||||||95.0|64.0|88.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||88|64|
73800267|NCT00116779|147149375|SUPERIORITY_OR_OTHER||Percentage of participants|90.0||||||95.0|79.0|96.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||96|79|
73800268|NCT00116779|147149375|SUPERIORITY_OR_OTHER||Percentage of participants|89.0||||||95.0|78.0|95.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||95|78|
73800269|NCT00116779|147149375|SUPERIORITY_OR_OTHER|||||||0.8413||95.0|||||Chi-squared|||||||0.8413
73800270|NCT00116779|147149376|SUPERIORITY_OR_OTHER||Percentage of participants|93.0||||||95.0|82.0|99.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||99|82|
73800271|NCT00116779|147149376|SUPERIORITY_OR_OTHER||Percentage of participants|98.0||||||95.0|87.0|100.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||100|87|
73800272|NCT00116779|147149377|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Log Rank|||Time to 50% reduction||||.904
73800273|NCT00116779|147149377|SUPERIORITY_OR_OTHER|||||||0.778||95.0|||||Log Rank|||Days to 90% reduction||||.778
73800274|NCT01690117|147149387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.47|STANDARD_ERROR_OF_MEAN|1.83|<|0.001|TWO_SIDED|95.0|3.82|11.12||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||11.12|3.82|<0.001
73800275|NCT01690117|147149388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.43|STANDARD_ERROR_OF_MEAN|2.21|<|0.05|TWO_SIDED|95.0|1.0|9.86||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||9.86|1.00|<0.05
73800276|NCT01690117|147149389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.99|STANDARD_ERROR_OF_MEAN|1.0|<|0.01|TWO_SIDED|95.0|1.01|4.97||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||4.97|1.01|<0.01
73800277|NCT01690117|147149390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.87||0.06|TWO_SIDED|95.0|-0.05|3.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||3.45|-0.05|0.06
73800278|NCT01690117|147149391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|1.22||0.3|TWO_SIDED|95.0|-0.65|2.07||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.07|-0.65|0.30
73800279|NCT01690117|147149392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|1.02||0.24|TWO_SIDED|95.0|-0.66|2.59||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.59|-0.66|0.24
73800280|NCT01690117|147149393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|1.04|<|0.05|TWO_SIDED|95.0|-2.5|1.62||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||1.62|-2.50|<0.05
73800281|NCT01690117|147149394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|8.86||0.88|TWO_SIDED|95.0|-2.63|2.25||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.25|-2.63|0.88
73800282|NCT01690117|147149395|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.93|STANDARD_ERROR_OF_MEAN|1.92|<|0.05|TWO_SIDED|95.0|-8.74|-1.11||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-1.11|-8.74|<0.05
73800283|NCT01690117|147149396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-13.31|-3.66||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-3.66|-13.31|<0.001
73800284|NCT01690117|147149397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.91|STANDARD_ERROR_OF_MEAN|1.98||0.05|TWO_SIDED|95.0|-7.86|0.04||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||0.04|-7.86|0.05
73800285|NCT01690117|147149398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.1||0.91|TWO_SIDED|95.0|-3.96|4.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||4.45|-3.96|0.91
73800286|NCT01690117|147149399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|1.47||0.05|TWO_SIDED|95.0|-0.01|5.81||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||5.81|-0.01|0.05
73800287|NCT01690117|147149400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|1.91|<|0.05|TWO_SIDED|95.0|0.68|8.33||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||8.33|0.68|<0.05
73800288|NCT01690117|147149401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53|STANDARD_ERROR_OF_MEAN|1.95|<|0.01|TWO_SIDED|95.0|-8.4|-0.65||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-0.65|-8.40|<0.01
73800289|NCT01690117|147149402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|1.52|<|0.01|TWO_SIDED|95.0|4.78|10.83||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||10.83|4.78|<0.01
73800290|NCT01037218|147149414|SUPERIORITY_OR_OTHER||Difference in LS Means|3.38|||<|0.0001|TWO_SIDED|95.0|1.7|5.07|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||5.07|1.70|<0.0001
73800291|NCT01037218|147149414|SUPERIORITY_OR_OTHER||Difference in LS Means|5.74|||<|0.0001|TWO_SIDED|95.0|4.05|7.43|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||7.43|4.05|<0.0001
73800292|NCT01037218|147149414|SUPERIORITY_OR_OTHER||Difference in LS Means|7.53|||<|0.0001|TWO_SIDED|95.0|5.86|9.2|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||9.20|5.86|<0.0001
73800293|NCT01037218|147149415|SUPERIORITY_OR_OTHER||Difference in LS Means|20.19|||<|0.0001|TWO_SIDED|95.0|13.44|26.93|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||26.93|13.44|<0.0001
73800294|NCT01037218|147149415|SUPERIORITY_OR_OTHER||Difference in LS Means|25.06|||<|0.0001|TWO_SIDED|95.0|18.32|31.81|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||31.81|18.32|<0.0001
73800295|NCT01037218|147149415|SUPERIORITY_OR_OTHER||Difference in LS Means|32.84|||<|0.0001|TWO_SIDED|95.0|26.18|39.5|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||39.50|26.18|<0.0001
73893660|NCT01708902|147320185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.169|STANDARD_ERROR_OF_MEAN|1.565||0.0001|TWO_SIDED|95.0|1.997|8.701|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||8.701|1.997|0.0001
73800296|NCT01037218|147149416|SUPERIORITY_OR_OTHER||Difference in LS Means|21.72|||<|0.0001|TWO_SIDED|95.0|14.19|29.24|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||29.24|14.19|<0.0001
73893661|NCT01708902|147320186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.661|STANDARD_ERROR_OF_MEAN|0.426||0.048|TWO_SIDED|95.0|1.004|2.746|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.746|1.004|0.0480
73893662|NCT01708902|147320186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.923|STANDARD_ERROR_OF_MEAN|1.632|<|0.0001|TWO_SIDED|95.0|3.452|10.164|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||10.164|3.452|<0.0001
73893663|NCT01708902|147320186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.574|STANDARD_ERROR_OF_MEAN|0.655||0.0002|TWO_SIDED|95.0|1.563|4.239|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||4.239|1.563|0.0002
73893664|NCT01708902|147320186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.682|STANDARD_ERROR_OF_MEAN|1.27|<|0.0001|TWO_SIDED|95.0|2.751|7.968|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||7.968|2.751|<0.0001
73893665|NCT01708902|147320187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.135|STANDARD_ERROR_OF_MEAN|1.31||0.0062|TWO_SIDED|95.0|1.383|7.11|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||7.110|1.383|0.0062
73893666|NCT01708902|147320188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0109|TWO_SIDED|95.0|-0.53|-0.07|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.07|-0.53|0.0109
73893667|NCT01708902|147320188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.27|-0.81|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.81|-1.27|<0.0001
73893668|NCT01708902|147320188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.7|-0.24|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID ' minus 'Main: Metformin 500mg BID' .|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.24|-0.70|<0.0001
73893669|NCT01708902|147320188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.58|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.58|-1.04|<0.0001
73893670|NCT01708902|147320189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.32||0.0001|TWO_SIDED|95.0|-1.87|-0.63|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|"The treatment effect of the 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' was compared with 'APG: Linagliptin 5mg QD'.~The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate."||-0.63|-1.87|0.0001
73893671|NCT01708902|147320190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986|STANDARD_ERROR_OF_MEAN|0.387||0.9705|TWO_SIDED|95.0|0.456|2.13|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.130|0.456|0.9705
73893672|NCT01708902|147320190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.093|STANDARD_ERROR_OF_MEAN|1.029||0.0007|TWO_SIDED|95.0|1.612|5.938|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||5.938|1.612|0.0007
73893673|NCT01708902|147320190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|STANDARD_ERROR_OF_MEAN|1.243||0.0029|TWO_SIDED|95.0|1.486|6.849|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||6.849|1.486|0.0029
73893674|NCT01708902|147320190|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.871|STANDARD_ERROR_OF_MEAN|1.846|<|0.0001|TWO_SIDED|95.0|2.318|10.238|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||10.238|2.318|<0.0001
73893675|NCT01708902|147320191|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.865|STANDARD_ERROR_OF_MEAN|1.015||0.2523|TWO_SIDED|95.0|0.642|5.42|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||5.420|0.642|0.2523
73893676|NCT01708902|147320192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.37|STANDARD_ERROR_OF_MEAN|3.23||0.0971|TWO_SIDED|95.0|-11.72|0.98|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||0.98|-11.72|0.0971
73893677|NCT01708902|147320192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.42|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-38.67|-26.16|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-26.16|-38.67|<0.0001
73893678|NCT01708902|147320192|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.47|STANDARD_ERROR_OF_MEAN|3.16||0.0028|TWO_SIDED|95.0|-15.66|-3.27|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-3.27|-15.66|0.0028
73893679|NCT01708902|147320192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.31|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|-30.54|-18.08|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-18.08|-30.54|<0.0001
73893680|NCT01708902|147320193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.21|STANDARD_ERROR_OF_MEAN|9.23||0.0002|TWO_SIDED|95.0|-53.48|-16.95|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-16.95|-53.48|0.0002
73893681|NCT01708902|147320194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.209|STANDARD_ERROR_OF_MEAN|0.148||0.0271|TWO_SIDED|95.0|0.052|0.838|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||0.838|0.052|0.0271
73893682|NCT01708902|147320194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.965|STANDARD_ERROR_OF_MEAN|0.916||0.9699|TWO_SIDED|95.0|0.15|6.202|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||6.202|0.150|0.9699
73893683|NCT01708902|147320194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.183|STANDARD_ERROR_OF_MEAN|0.147||0.0343|TWO_SIDED|95.0|0.038|0.882|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||0.882|0.038|0.0343
73893684|NCT01708902|147320195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.114|STANDARD_ERROR_OF_MEAN|0.125||0.0474|TWO_SIDED|95.0|0.013|0.976|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||0.976|0.013|0.0474
73893685|NCT02633020|147320197|SUPERIORITY||LS Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|14.7||0.7451|TWO_SIDED|90.0|-30.26|20.56|||ANCOVA|Analysis of covariance (ANCOVA) with baseline % aberrant IELs vs total IELs as a covariate and treatment group as a fixed effect.||||20.56|-30.26|0.7451
73893686|NCT02633020|147320198|SUPERIORITY||LS Mean Difference|-38.22|STANDARD_ERROR_OF_MEAN|27.48||0.1803|TWO_SIDED|95.0|-95.73|19.29|||ANCOVA|ANCOVA model with baseline % aberrant IELs vs intestinal epithelial cells as a covariate and treatment group as a fixed effect.||||19.29|-95.73|0.1803
73893687|NCT02633020|147320199|SUPERIORITY||LS Mean Difference|10.67|STANDARD_ERROR_OF_MEAN|24.0||0.6607|TWO_SIDED|95.0|-38.97|60.31|||ANCOVA|ANCOVA model with baseline VH:CD ratio as a covariate and treatment group as a fixed effect.||||60.31|-38.97|0.6607
73893688|NCT02633020|147320200|SUPERIORITY||Odds Ratio (OR)|1.09||||0.9204|TWO_SIDED|95.0|0.2|6.01|||Regression, Logistic|||||6.01|0.20|0.9204
73893689|NCT02633020|147320201|SUPERIORITY||LS Mean Difference|-12.73|STANDARD_ERROR_OF_MEAN|31.34||0.6885|TWO_SIDED|95.0|-77.57|52.12|||ANCOVA|ANCOVA) model with baseline total IEL counts as a covariate and treatment group as a fixed effect.||||52.12|-77.57|0.6885
73893690|NCT02633020|147320202|SUPERIORITY||Ratio of LS Means|1.17|STANDARD_ERROR_OF_MEAN|0.24||0.4469|TWO_SIDED|95.0|0.77|1.8|||Generalized Linear Mixed Model|Generalized linear mixed model with subject as a random effect and treatment group, time (week) and their interaction as fixed effects.||||1.8|0.77|0.4469
73893691|NCT02633020|147320204|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.19||0.4832|TWO_SIDED|95.0|-0.53|0.26|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and time point-by-treatment group as fixed effects.||||0.26|-0.53|0.4832
73893692|NCT02633020|147320205|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.24||0.5561|TWO_SIDED|95.0|-0.64|0.35|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and a time point-by-treatment group as fixed effects.||||0.35|-0.64|0.5561
73893693|NCT01136785|147320213|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||two-sided t test for the change from baseline between the treated and untreated groups.||||0.01
73893694|NCT01136785|147320214|SUPERIORITY_OR_OTHER|||||||0.011|||||||2-sided Paired t-test|||comparing pre and post Interstitial Glucose levels in the active CPAP group||||0.011
73893695|NCT01136785|147320215|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
73893696|NCT01136785|147320216|SUPERIORITY_OR_OTHER|||||||0.754|||||||two-sided paired t-test|||Plasma cortisol pre and post 1-week of active CPAP||||0.754
73893697|NCT01136785|147320217|SUPERIORITY_OR_OTHER|||||||0.308|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group||||0.308
73893698|NCT01136785|147320218|SUPERIORITY_OR_OTHER|||||||0.036|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group||||0.036
73893699|NCT00800254|147320219|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
73893700|NCT00800254|147320221|SUPERIORITY_OR_OTHER||||||<|0.003|TWO_SIDED||||||ANCOVA|||||||<0.003
73893701|NCT01057589|147320235|SUPERIORITY_OR_OTHER|||||||0.697||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.697
73893702|NCT01057589|147320235|SUPERIORITY_OR_OTHER|||||||0.132||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.132
73893703|NCT01057589|147320236|SUPERIORITY_OR_OTHER|||||||0.223||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.223
73893704|NCT01057589|147320236|SUPERIORITY_OR_OTHER|||||||0.788||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.788
73893705|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.9||||||P-value is for NOD, Triplicate Combination Therapy Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.90
73893706|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.31||||||P-value is for NOD, Triplicate Combination Therapy Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.31
73800297|NCT01037218|147149416|SUPERIORITY_OR_OTHER||Difference in LS Means|26.82|||<|0.0001|TWO_SIDED|95.0|19.27|34.37|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||34.37|19.27|<0.0001
73800298|NCT01037218|147149416|SUPERIORITY_OR_OTHER||Difference in LS Means|35.41|||<|0.0001|TWO_SIDED|95.0|27.98|42.83|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||42.83|27.98|<0.0001
73800299|NCT01037218|147149417|SUPERIORITY_OR_OTHER||Difference in LS Means|1.52|||<|0.0001|TWO_SIDED|95.0|0.81|2.23|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.23|0.81|<0.0001
73800300|NCT01037218|147149417|SUPERIORITY_OR_OTHER||Difference in LS Means|2.29|||<|0.0001|TWO_SIDED|95.0|1.58|3.0|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||3.00|1.58|<0.0001
73800301|NCT01037218|147149417|SUPERIORITY_OR_OTHER||Difference in LS Means|2.9|||<|0.0001|TWO_SIDED|95.0|2.2|3.6|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||3.60|2.20|<0.0001
73800302|NCT01037218|147149418|SUPERIORITY_OR_OTHER||Difference in LS Means|0.59||||0.0673|TWO_SIDED|95.0|-0.04|1.22|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.22|-0.04|0.0673
73800303|NCT01037218|147149418|SUPERIORITY_OR_OTHER||Difference in LS Means|1.53|||<|0.0001|TWO_SIDED|95.0|0.9|2.16|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.16|0.90|<0.0001
73800304|NCT01037218|147149418|SUPERIORITY_OR_OTHER||Difference in LS Means|1.53|||<|0.0001|TWO_SIDED|95.0|0.91|2.15|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.15|0.91|<0.0001
73800305|NCT01037218|147149419|SUPERIORITY_OR_OTHER||Difference in LS Means|0.36||||0.0566|TWO_SIDED|95.0|-0.01|0.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.73|-0.01|0.0566
73893707|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.49||||||P-value is for NOD, Triplicate Combination Therapy Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.49
73893708|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.95||||||P-value is for NOD, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.95
73893709|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.89||||||P-value is for NOD, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.89
73893710|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.36||||||P-value is for NOD, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.36
73893711|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value is for NOD, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.18
73893712|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.47||||||P-value is for EIP, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.47
73893713|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for EIP, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.17
73893714|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.45||||||P-value is for EIP, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.45
73893715|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.29||||||P-value is for EIP, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.29
73893716|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for EIP, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.17
73893717|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value is for EIP, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.70
73893718|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.21||||||P-value is for EIP, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.21
73893719|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.85||||||P-value is for UOS, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.85
73893720|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.13||||||P-value is for UOS, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.13
73800306|NCT01037218|147149419|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.0002|TWO_SIDED|95.0|0.34|1.08|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.08|0.34|0.0002
73800307|NCT01037218|147149419|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.0001|TWO_SIDED|95.0|0.34|1.07|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.07|0.34|0.0001
73893721|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for UOS, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.03
73893722|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.71||||||P-value is for UOS, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.71
73893723|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.34||||||P-value is for UOS, Maintenance Cycle 3. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.34
73893724|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value is for UOS, Maintenance Cycle 5. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.41
73893725|NCT01057589|147320237|SUPERIORITY_OR_OTHER|||||||0.37||||||P-value is for UOS, Maintenance Cycle 7. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.37
73893726|NCT02954172|147320247|EQUIVALENCE|the equivalence margin of the ORR ratio was set at (0.75, 1.33).|Odds Ratio (OR)|0.9|||||TWO_SIDED|90.0|0.756|1.077||||||||1.077|0.756|
73893727|NCT02954172|147320248|EQUIVALENCE|||||||0.7066|||||||Log Rank|||||||0.7066
73893728|NCT02954172|147320249|EQUIVALENCE|||||||0.3497|||||||Log Rank|||||||0.3497
73893729|NCT01497366|147320254|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 rates was greater than -15%.|Difference in percentages|0.3|||||TWO_SIDED|95.0|-7.5|8.0|||||The difference in percentages between treatment groups and the 95% CI calculated were based on stratum adjusted Mantel-Haenszel proportions.|||8.0|-7.5|
73893730|NCT02745080|147320274|SUPERIORITY||Odds Ratio (OR)|1.3||||0.0719|TWO_SIDED|95.0|0.98|1.72|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.72|0.98|0.0719
73893731|NCT02745080|147320275|SUPERIORITY||Odds Ratio (OR)|2.49|||<|0.0001|TWO_SIDED|95.0|1.67|3.71|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||3.71|1.67|<0.0001
73893732|NCT02745080|147320276|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2251|TWO_SIDED|95.0|0.9|1.55|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.55|0.90|0.2251
73893733|NCT02745080|147320277|SUPERIORITY||least squares (LS) mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.038||0.5465|TWO_SIDED|95.0|-0.1|0.05|||Mixed Models Analysis||Mixed model repeated measures (MMRM) with treatment group, analysis visit as factors, weight/baseline score as covariates, treatment by analysis visit, baseline score by analysis visit as interation terms and unstructured covariance structure|||0.05|-0.10|0.5465
73893734|NCT02745080|147320278|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1498|TWO_SIDED|95.0|0.91|1.87|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.87|0.91|0.1498
73893735|NCT02758184|147320279|OTHER||Mean Difference (Final Values)|1031.2|STANDARD_ERROR_OF_MEAN|681.7||0.15|TWO_SIDED||||||ANOVA|||||||0.15
73893736|NCT00531427|147320293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0853|TWO_SIDED|95.0|-0.8|0.05|||Mixed Models Analysis|Statistics are based on a mixed effect general linear model||"\[Week 12 analysis\] The null hypothesis was no group differences. The alternative hypothesis was that BTDS arm was superior to the placebo arm.~Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)."||0.05|-0.80|0.0853
73893737|NCT00531427|147320294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.7098|TWO_SIDED|95.0|-0.233|0.159||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|ANCOVA|with treatment as a factor and screening and pre-randomization mean pain as covariates.||Categorical analysis P value is based on a Fisher's exact test. Mean daily number of tablets for subjects who took \<=1 dose of supplemental analgesia||0.159|-0.233|0.7098
73800308|NCT01037218|147149420|SUPERIORITY_OR_OTHER||Difference in LS Means|0.86||||0.0019|TWO_SIDED|95.0|0.32|1.4|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.40|0.32|0.0019
73800309|NCT01037218|147149420|SUPERIORITY_OR_OTHER||Difference in LS Means|1.55|||<|0.0001|TWO_SIDED|95.0|1.01|2.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.09|1.01|<0.0001
73800310|NCT01037218|147149420|SUPERIORITY_OR_OTHER||Difference in LS Means|2.09|||<|0.0001|TWO_SIDED|95.0|1.55|2.62|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.62|1.55|<0.0001
73800311|NCT01037218|147149421|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
73800312|NCT01037218|147149421|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
73800313|NCT01037218|147149421|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
73800314|NCT01037218|147149421|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
73800315|NCT01037218|147149422|SUPERIORITY_OR_OTHER||Difference in LS Means|12.65|||<|0.0001|TWO_SIDED|95.0|7.01|18.29|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||18.29|7.01|<0.0001
73800316|NCT01037218|147149422|SUPERIORITY_OR_OTHER||Difference in LS Means|19.61|||<|0.0001|TWO_SIDED|95.0|13.95|25.27|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||25.27|13.95|<0.0001
73800317|NCT01037218|147149422|SUPERIORITY_OR_OTHER||Difference in LS Means|27.01|||<|0.0001|TWO_SIDED|95.0|21.44|32.59|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||32.59|21.44|<0.0001
73800318|NCT01037218|147149423|SUPERIORITY_OR_OTHER||Difference in LS Means|0.44|||<|0.0001|TWO_SIDED|95.0|0.3|0.57|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.57|0.30|<0.0001
73800319|NCT01037218|147149423|SUPERIORITY_OR_OTHER||Difference in LS Means|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.68|0.40|<0.0001
73800320|NCT01037218|147149423|SUPERIORITY_OR_OTHER||Difference in LS Means|0.83|||<|0.0001|TWO_SIDED|95.0|0.69|0.97|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.97|0.69|<0.0001
73800321|NCT01037218|147149424|SUPERIORITY_OR_OTHER||Difference in LS Means|15.18|||<|0.0001|TWO_SIDED|95.0|10.21|20.14|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||20.14|10.21|<0.0001
73800322|NCT01037218|147149424|SUPERIORITY_OR_OTHER||Difference in LS Means|14.94|||<|0.0001|TWO_SIDED|95.0|9.96|19.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||19.92|9.96|<0.0001
73800323|NCT01037218|147149424|SUPERIORITY_OR_OTHER||Difference in LS Means|21.06|||<|0.0001|TWO_SIDED|95.0|16.15|25.96|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||25.96|16.15|<0.0001
73800324|NCT01037218|147149425|SUPERIORITY_OR_OTHER||Difference in LS Means|17.51|||<|0.0001|TWO_SIDED|95.0|10.22|24.81|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||24.81|10.22|<0.0001
73800325|NCT01037218|147149425|SUPERIORITY_OR_OTHER||Difference in LS Means|28.32|||<|0.0001|TWO_SIDED|95.0|21.01|35.62|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||35.62|21.01|<0.0001
73893738|NCT00531427|147320295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46||||0.0034|TWO_SIDED|95.0|-7.44|-1.48||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|Mixed Models Analysis|||Weeks 4, 8, 12 analysis The sleep disturbance subscale was analyzed using the mixed effect linear model with fixed effects for treatment (BTDS or placebo) and time (weeks 1, 2, 4, 8, 12) as categorical, screening mean and prerandomization mean value as covariates, and subject as a random effect.||-1.48|-7.44|0.0034
73893739|NCT03036215|147320298|OTHER||Mean Difference (Net)|-7.0|||||TWO_SIDED|||||||||Pilot study, no power analysis applicable; no statistical test||||
73893740|NCT03036215|147320299|OTHER|pilot study; no statistical test performed|Mean Difference (Net)|1.0|||||TWO_SIDED|||||||||Pilot study; no statistical test run||||
73893741|NCT03036215|147320300|OTHER||Mean Difference (Net)|-5.2|||||TWO_SIDED|||||||||Pilot study; no statistical test for significance run||||
73800326|NCT01037218|147149425|SUPERIORITY_OR_OTHER||Difference in LS Means|33.82|||<|0.0001|TWO_SIDED|95.0|26.61|41.02|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||41.02|26.61|<0.0001
73893742|NCT01303224|147320301|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Multiplicity was adjusted by using the Hochberg Procedure.|Mantel Haenszel|||Mantel-Haenszel-Test was used to compare separately each of the 3 active treatment groups with placebo using a two-sided overall significance level of 5%. The proportion of responders was tested with the following hypotheses: H0 (placebo) vs H1(Ibodutant:1mg/3mg/10mg). Approximately 80% power based on the assumptions: rate placebo 40%, expected mean therapeutic gain over placebo 15% for at least one dose of Ibodutant.||||<0.05
73893743|NCT01303224|147320302|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Multiplicity was adjusted using the Hochberg procedure.|Mantel Haenszel|||||||<0.05
73893744|NCT00843284|147320312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.16|STANDARD_DEVIATION|2.52|<|0.0001||95.0|-4.35|-3.97|||t-test, 2 sided|One sample t-test||Change from Baseline; observational study||-3.97|-4.35|<0.0001
73893745|NCT00843284|147320313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.02|STANDARD_DEVIATION|2.9|<|0.0001||95.0|-4.24|-3.8|||t-test, 2 sided|One sample t-test.||Change from baseline||-3.80|-4.24|<0.0001
73893746|NCT00724711|147320331|NON_INFERIORITY_OR_EQUIVALENCE|"This study was designed to show noninferiority (change of \< 12%) in regard of proportions of responders (TLOVR) at Week 48.~With 170 subjects in each group, the lower limit of observed one-sided 97.5% confidence interval was expected to be greater than -0.120 with 80% power when the proportion of responders in both treatment groups is 0.820 (82%) at Week 48.~312 subjects were enrolled, representing 8% less than planned (n = 340). As a result, power to claim non-inferiority decreased to 78%."|Difference in percentages between groups|3.0|||||TWO_SIDED|95.0|-5.1|11.2|||Inverted two one-sided tests|Inverted two one-sided tests with the standardized statistic||"Null hypothesis: The TVD group is at least 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)~Alternative hypothesis: The TVD group is less than 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)"||11.2|-5.1|
73893747|NCT05111301|147320367|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.004
73893748|NCT05111301|147320368|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.004
73893749|NCT05111301|147320369|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.54
73893750|NCT05111301|147320370|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.03
73893751|NCT05111301|147320371|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.001
73893752|NCT05111301|147320372|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.01
73800327|NCT01037218|147149426|SUPERIORITY_OR_OTHER||Difference in LS Means|18.73|||<|0.0001|TWO_SIDED|95.0|11.23|26.23|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||26.23|11.23|<0.0001
73893753|NCT05111301|147320373|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.80
73893754|NCT04838977|147320408|SUPERIORITY||Between group difference|-4.2|||||TWO_SIDED|95.0|-7.6|-0.8||||||The null hypothesis is there is no difference in mean CPSS at 10 weeks in the intervention group versus the control group.||-0.8|-7.6|
73893755|NCT00621348|147320433|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis|Risk Ratio (RR)|0.12|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED|95.0|0.016|0.93||p value was adjusted for multiple comparisons.|Fisher Exact||The risk ratio is for Group A compared with Group C.|The incidence of hospital-acquired hyponatremia with current standard intravenous fluid therapy was approximately 30%. Sample of 72 patients would be needed in each group to demonstrate the decrease in incidence of hyponatremia (defined as plasma sodium\< 130 mEq/L) to 10%, with a power of 80 percent and alpha error of 0.05. In view of short study period and feasibility it was planned a priori to enroll at least 50 patients in each treatment limb.||0.93|0.016|<0.05
73893756|NCT03120351|147320446|SUPERIORITY||Mean Difference (Net)|-2.5||||0.28|TWO_SIDED|95.0|-7.11|2.06|||Mixed Models Analysis|||||2.06|-7.11|0.28
73893757|NCT01256190|147320447|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
73893758|NCT01256190|147320448|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||||||0.31
73893759|NCT01256190|147320449|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||intent-to-treat analysis||||.022
73893760|NCT01256190|147320450|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Fisher Exact|||intent-to treat analysis||||0.113
73893761|NCT01256190|147320451|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Fisher Exact|||intent-to-treat analysis||||.025
73893762|NCT02197078|147320458|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.66|1.03||||||||1.03|0.66|
73893763|NCT02197078|147320458|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.65|1.1||||||||1.10|0.65|
73893764|NCT02197078|147320458|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.49|0.86||||||||0.86|0.49|
73893765|NCT02197078|147320458|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.83|1.1||||||||1.10|0.83|
73893766|NCT02197078|147320458|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.85|1.19||||||||1.19|0.85|
73893767|NCT02197078|147320458|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.66|0.96||||||||0.96|0.66|
73893768|NCT02197078|147320459|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.66|1.23||||||||1.23|0.66|
73893769|NCT02197078|147320459|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.57|1.16||||||||1.16|0.57|
73800328|NCT01037218|147149426|SUPERIORITY_OR_OTHER||Difference in LS Means|29.39|||<|0.0001|TWO_SIDED|95.0|21.86|36.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||36.92|21.86|<0.0001
73800329|NCT01037218|147149426|SUPERIORITY_OR_OTHER||Difference in LS Means|34.35|||<|0.0001|TWO_SIDED|95.0|26.94|41.75|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001(NCT00282607).||41.75|26.94|<0.0001
73800330|NCT01651117|147149435|EQUIVALENCE|Mixed methods ANCOVA with patient random effects, to compare change in HbA1c from baseline to 6 months between treatment and control groups.|Mean Difference (Final Values)|-0.3268|STANDARD_ERROR_OF_MEAN|0.1739||0.0611|TWO_SIDED|95.0|-0.669|0.0154||Subject random effect included because same model was used for analyses of 2 separate follow up periods (baseline to 6 month, and baseline to 12 month, reported separately).|Mixed Models Analysis|Multiple imputation used for intent-to-treat analysis.|Negative parameter estimate means decrease in HbA1c was greater for treatment group than for control group.|||0.0154|-0.6690|0.0611
73800331|NCT02714218|147149475|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0144|TWO_SIDED|95.0|0.38|0.9|||Cochran-Mantel-Haenszel|Two-sided p-value CMH Test for comparison of odds ratio of NIVO 3 + IPI 1 over NIVO 1 + IPI 3||||0.90|0.38|0.0144
73800332|NCT02714218|147149475|SUPERIORITY||Estimated Difference of rates|-12.7|||||TWO_SIDED|95.0|-22.7|-2.6|||||Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS|||-2.6|-22.7|
73800333|NCT02714218|147149476|SUPERIORITY||Odds Ratio (OR)|0.55||||0.0059|TWO_SIDED|95.0|0.36|0.84|||Cochran-Mantel-Haenszel|Two-sided p-value CMH Test for comparison of odds ratio of NIVO 3 + IPI 1 over NIVO 1 + IPI 3||||0.84|0.36|0.0059
73800334|NCT02714218|147149476|SUPERIORITY||Estimated Difference of rates|-14.4|||||TWO_SIDED|95.0|-24.5|-4.3|||||Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS|||-4.3|-24.5|
73800335|NCT02714218|147149477|SUPERIORITY||Odds Ratio (OR)|0.8||||0.2923|TWO_SIDED|95.0|0.53|1.21|||Cochran-Mantel-Haenszel||p-value from CMH Test for the comparison of the odds ratio of N3I1 over N1I3|||1.21|0.53|0.2923
73800336|NCT02714218|147149478|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.79|1.47|||||Hazard Ratio is N3I1 over N1I3. (NIVO 3 + IPI 1 (N3I1) over NIVO 1 + IPI 3 (N1I3))|||1.47|0.79|
73800337|NCT02714218|147149479|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.4512|TWO_SIDED|95.0|0.84|1.48|||Log Rank|||||1.48|0.84|0.4512
73800338|NCT02550561|147149554|SUPERIORITY|||||||0.317||||||Subjects that reported either moderately or markedly improved on the GRA scale at 6 weeks compared to 12 weeks.|McNemar|||||||0.317
73800339|NCT02550561|147149555|OTHER|||||||0.47|||||||paired t-tests|||The mean change in Visual Analog Scale (VAS) score for bladder pain||||0.47
73800340|NCT02550561|147149555|OTHER|||||||0.17|||||||paired t-test|||The mean change in Pelvis Pain and Urgency/Frequency Patient Symptom (PUF) score||||0.17
73800341|NCT02550561|147149555|OTHER|||||||0.08|||||||paired t-test|||The mean change for O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)||||.08
73800342|NCT02550561|147149555|OTHER|||||||0.51|||||||paired t-test|||The mean change O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)||||0.51
73800343|NCT02550561|147149555|OTHER|||||||0.22|||||||paired t-test|||The mean change in 24-h urinary frequency||||0.22
73800344|NCT04052620|147149562|NON_INFERIORITY|Non-inferiority criteria: if the upper 95% Confidence Interval (CI) of Least Square (LS) mean difference was less than 13 mm then DDEA 2.32% gel BID was concluded as non-inferior.|Mean Difference (Final Values)|1.11|STANDARD_ERROR_OF_MEAN|2.09||0.595|TWO_SIDED|95.0|-3.0|5.22|||ANCOVA|||||5.22|-3.00|0.5950
73800345|NCT04052620|147149564|OTHER||Mean Difference (Final Values)|-2.43|STANDARD_ERROR_OF_MEAN|2.12||0.2536|TWO_SIDED|95.0|-6.61|1.75|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||1.75|-6.61|0.2536
73800346|NCT04052620|147149564|OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|1.76||0.6643|TWO_SIDED|95.0|-4.23|2.7|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||2.70|-4.23|0.6643
73800347|NCT04052620|147149565|OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.19||0.3118|TWO_SIDED|95.0|-1.13|3.54|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||3.54|-1.13|0.3118
73800348|NCT04052620|147149565|OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|1.35||0.4937|TWO_SIDED|95.0|-3.6|1.74|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||1.74|-3.60|0.4937
73800349|NCT04052620|147149565|OTHER||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|1.67||0.3825|TWO_SIDED|95.0|-1.83|4.74|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||4.74|-1.83|0.3825
73800350|NCT04052620|147149566|OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.26||0.836|TWO_SIDED|95.0|-2.23|2.75|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||2.75|-2.23|0.8360
73800351|NCT04052620|147149566|OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|1.24||0.3119|TWO_SIDED|95.0|-3.69|1.18|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||1.18|-3.69|0.3119
73800352|NCT04052620|147149566|OTHER||Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|1.45||0.2535|TWO_SIDED|95.0|-1.2|4.52|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||4.52|-1.20|0.2535
73800353|NCT04052620|147149567|OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|1.51||0.6242|TWO_SIDED|95.0|-2.23|3.71|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||3.71|-2.23|0.6242
73800354|NCT04052620|147149567|OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|2.06||0.8905|TWO_SIDED|95.0|-4.33|3.77|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||3.77|-4.33|0.8905
73893770|NCT02197078|147320459|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.01||||||||1.01|0.48|
73800355|NCT04052620|147149567|OTHER||Mean Difference (Final Values)|2.12|STANDARD_ERROR_OF_MEAN|2.24||0.3439|TWO_SIDED|95.0|-2.29|6.54|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||6.54|-2.29|0.3439
73800356|NCT04052620|147149568|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1554|TWO_SIDED|95.0|-0.44|0.07|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||0.07|-0.44|0.1554
73800357|NCT04052620|147149568|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.0047|TWO_SIDED|95.0|-0.66|-0.12|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||-0.12|-0.66|0.0047
73800358|NCT04052620|147149568|OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0082|TWO_SIDED|95.0|-0.66|-0.1|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||-0.10|-0.66|0.0082
73800359|NCT04052620|147149569|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.2182|TWO_SIDED|95.0|-0.3|0.07|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||0.07|-0.30|0.2182
73800360|NCT04052620|147149569|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0574|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||0.01|-0.36|0.0574
73800361|NCT04052620|147149569|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0194|TWO_SIDED|95.0|-0.37|-0.03|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||-0.03|-0.37|0.0194
73800362|NCT04052620|147149570|OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.821||0.6545|TWO_SIDED|95.0|-1.25|1.986|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 1|||1.986|-1.250|0.6545
73800363|NCT04052620|147149570|OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.721||0.4924|TWO_SIDED|95.0|-1.915|0.924|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||0.924|-1.915|0.4924
73800364|NCT04052620|147149571|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.823||0.9491|TWO_SIDED|95.0|-1.675|1.57|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 1|||1.570|-1.675|0.9491
73800365|NCT04052620|147149571|OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.451||0.582|TWO_SIDED|95.0|-2.059|3.659|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||3.659|-2.059|0.5820
73800366|NCT01112059|147149610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.05|TWO_SIDED|95.0|0.128|0.633|||Wilcoxon (Mann-Whitney)|||||0.633|0.128|<0.05
73893771|NCT02197078|147320459|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.85|1.28||||||||1.28|0.85|
73800367|NCT02218463|147149640|SUPERIORITY|||||||0.206|||||||Fisher Exact|||Assessment of complete resolution between the 2 study arms.||||0.206
73800368|NCT02218463|147149641|SUPERIORITY|||||||0.0001|||||||ANOVA|||Time Effect||||0.0001
73800369|NCT02218463|147149641|SUPERIORITY|||||||0.37|||||||ANOVA|||Treatment Effect||||0.370
73800370|NCT02218463|147149641|SUPERIORITY|||||||0.425|||||||ANOVA|||Treatment by time interaction||||0.425
73800371|NCT06700512|147149642|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|paired||"H0 (Objective 1) SRT (study HA) is either not significantly different from SRT without HAs or significantly worse than SRT without HAs.~H1(Objective 1) SRT(study HA) is significantly better than SRT without HAs. A mean difference in SRT of 1 dB measured with the Oldenburg sentence test can be assumed as a typical difference in speech intelligibility to show a clinically meaningful improvement."||||<0.001
73800372|NCT06700512|147149642|NON_INFERIORITY|A mean difference in SRT of 1 dB measured with the Oldenburg sentence test (Wagener et al, 1999a-c), can be assumed as a typical difference in speech intelligibility to show a clinically meaningful improvement (Kollmeier et al, 2011). Thus if SRT with study hearing aids is 1dB or more worse than with subjects' own hearing aids and the difference is significant (p\<0.05), inferiority of study hearing aid is assumed otherwise study hearing aids are considered non-inferior|||||<|0.001||||||paired|t-test, 1 sided|||H0 (Objective 2) SRT (study HA) is significantly worse than SRT(own HAs). H1(Objective 2) There is no difference between SRT(study HA) and SRT(own HAs) or SRT (study HA) is significantly better than SRT (own HAs) SRT= Speech Reception Threshold in dB||||<0.001
73800373|NCT05085834|147149659|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.71|STANDARD_ERROR_OF_MEAN|0.14|<|0.01|TWO_SIDED|95.0|0.43|0.98|||linear combination of coefficients|||effect of Zinc supplementation on ln(Zinc, μg/dL)||0.98|0.43|<0.01
73800374|NCT05085834|147149660|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.002|STANDARD_ERROR_OF_MEAN|0.29||1|TWO_SIDED|95.0|-0.57|0.57|||linear combination of coefficients|||effect of Zinc supplementation on ln(hsCRP ng/mL)||0.57|-0.57|1.00
73800375|NCT05085834|147149660|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.08|TWO_SIDED|95.0|-0.18|0.01|||linear combination of coefficients|||effect of Zinc supplementation on ln(sCD14, ng/mL)||0.01|-0.18|0.08
73800376|NCT05085834|147149660|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.77|TWO_SIDED|95.0|-0.21|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(sCD163, ng/mL)||0.15|-0.21|0.77
73800377|NCT05085834|147149660|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.2|STANDARD_ERROR_OF_MEAN|0.15||0.19|TWO_SIDED|95.0|-0.1|0.5|||linear combination of coefficients|||effect of Zinc supplementation on ln(D-dimer, ng/mL)||0.50|-0.10|0.19
73893772|NCT02197078|147320459|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.79|1.28||||||||1.28|0.79|
73893773|NCT02197078|147320459|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.62|1.06||||||||1.06|0.62|
73893774|NCT02197078|147320460|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.51|0.94||||||||0.94|0.51|
73800378|NCT05085834|147149660|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.19|STANDARD_ERROR_OF_MEAN|0.11||0.1|TWO_SIDED|95.0|-0.41|0.04|||linear combination of coefficients|||effect of Zinc supplementation on ln(VCAM, ng/mL)||0.04|-0.41|0.10
73800379|NCT05085834|147149660|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.41|STANDARD_ERROR_OF_MEAN|20.19||0.98|TWO_SIDED|95.0|-39.16|39.98|||linear combination of coefficients|||effect of Zinc supplementation on ln(ICAM, ng/mL)||39.98|-39.16|0.98
73800380|NCT05085834|147149661|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.55|TWO_SIDED|95.0|-0.09|0.16|||linear combination of coefficients|||effect of Zinc supplementation on ln(sTNF-RI , pg/mL)||0.16|-0.09|0.55
73800381|NCT05085834|147149661|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.004|STANDARD_ERROR_OF_MEAN|0.07||0.95|TWO_SIDED|95.0|-0.13|0.13|||linear combination of coefficients|||effect of Zinc supplementation on ln(sTNF-RII, pg/m)||0.13|-0.13|0.95
73800382|NCT05085834|147149661|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.19||0.73|TWO_SIDED|95.0|-0.3|0.43|||linear combination of coefficients|||effect of Zinc supplementation on ln(IL-6, pg/mL)||0.43|-0.30|0.73
73800383|NCT05085834|147149661|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.12|STANDARD_ERROR_OF_MEAN|0.18||0.48|TWO_SIDED|95.0|-0.22|0.47|||linear combination of coefficients|||effect of Zinc supplementation on ln(IP-10, pg/mL)||0.47|-0.22|0.48
73800384|NCT05085834|147149662|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|1819.18|STANDARD_ERROR_OF_MEAN|8530.03||0.83|TWO_SIDED|95.0|-14899.37|18537.74|||linear combination of coefficients|||effect of Zinc supplementation on ln(OxLDL, U/L)||18537.74|-14899.37|0.83
73800385|NCT05085834|147149663|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.84|TWO_SIDED|95.0|-0.12|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(Non-HDL Cholesterol (mg/dL))||0.15|-0.12|0.84
73800386|NCT05085834|147149663|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.18|TWO_SIDED|95.0|-0.19|0.04|||linear combination of coefficients|||effect of Zinc supplementation on ln(HDL (mg/dL))||0.04|-0.19|0.18
73800387|NCT05085834|147149663|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.09||0.84|TWO_SIDED|95.0|-0.19|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(LDL (mg/dL))||0.15|-0.19|0.84
73800388|NCT05085834|147149663|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.11||0.55|TWO_SIDED|95.0|-0.15|0.29|||linear combination of coefficients|||effect of Zinc supplementation on ln(VLDL (mg/dL))||0.29|-0.15|0.55
73800389|NCT05085834|147149663|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.78|TWO_SIDED|95.0|-0.11|0.09|||linear combination of coefficients|||effect of Zinc supplementation on ln(Cholesterol (mg/dl))||0.09|-0.11|0.78
73800390|NCT05085834|147149663|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.58|TWO_SIDED|95.0|-0.17|0.31|||linear combination of coefficients|||effect of Zinc supplementation on ln(Triglycerides (mg/dL))||0.31|-0.17|0.58
73893775|NCT02197078|147320460|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.44|0.9||||||||0.90|0.44|
73893776|NCT02197078|147320460|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.41|0.88||||||||0.88|0.41|
73893777|NCT02197078|147320460|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|0.81|
73893778|NCT02197078|147320460|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.77|1.19||||||||1.19|0.77|
73800391|NCT05085834|147149663|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.44|STANDARD_ERROR_OF_MEAN|0.47||0.35|TWO_SIDED|95.0|-1.36|0.48|||linear combination of coefficients|||effect of Zinc supplementation on Metabolic Syndrome||0.48|-1.36|0.35
73800392|NCT05085834|147149664|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.07||0.36|TWO_SIDED|95.0|-0.07|0.2|||linear combination of coefficients|||effect of Zinc supplementation on ln(Chol:HDL Ratio)||0.20|-0.07|0.36
73800393|NCT05085834|147149665|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.35|STANDARD_ERROR_OF_MEAN|2.01||0.86|TWO_SIDED|95.0|-4.29|3.6|||linear combination of coefficients|||effect of Zinc supplementation on BMI (kg/m2)||3.60|-4.29|0.86
73800394|NCT05085834|147149666|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.74|TWO_SIDED|95.0|-0.08|0.05|||linear combination of coefficients|||effect of Zinc supplementation on ln(Waist-umbilicus (cm))||0.05|-0.08|0.74
73800395|NCT05085834|147149667|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-2.99|STANDARD_ERROR_OF_MEAN|12.23||0.81|TWO_SIDED|95.0|-26.97|20.99|||linear combination of coefficients|||effect of Zinc supplementation on Weight (lbs)||20.99|-26.97|0.81
73800396|NCT05085834|147149668|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|95.0|-0.07|0.03|||linear combination of coefficients|||effect of Zinc supplementation on ln(Systolic blood pressure (mmHg))||0.03|-0.07|0.41
73800397|NCT05085834|147149668|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-1.68|STANDARD_ERROR_OF_MEAN|2.06||0.42|TWO_SIDED|95.0|-5.71|2.36|||linear combination of coeff|||effect of Zinc supplementation on Diastolic blood pressure (mmHg)||2.36|-5.71|0.42
73800398|NCT05085834|147149669|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7|TWO_SIDED|95.0|-0.26|0.17|||linear combination of coefficients|||effect of Zinc supplementation on ln(10 year ASCVD (%))||0.17|-0.26|0.70
73800399|NCT05085834|147149670|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.62|TWO_SIDED|95.0|-0.17|0.1|||linear combination of coefficients|||effect of Zinc supplementation on Reactive Hyperemic Index||0.10|-0.17|0.62
73800400|NCT05085834|147149670|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.59|STANDARD_ERROR_OF_MEAN|2.43||0.81|TWO_SIDED|95.0|-4.19|5.36|||linear combination of coefficients|||effect of Zinc supplementation on Augmentation Index||5.36|-4.19|0.81
73800401|NCT05085834|147149671|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.9|TWO_SIDED|95.0|-0.26|0.3|||linear combination of coefficients|||effect of Zinc supplementation on ln(IFAB (pg/mL))||0.30|-0.26|0.90
73800402|NCT05085834|147149671|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.18|STANDARD_ERROR_OF_MEAN|0.15||0.24|TWO_SIDED|95.0|-0.12|0.47|||linear combination of coefficients|||effect of Zinc supplementation on ln(BDG (pg/mL))||0.47|-0.12|0.24
73893779|NCT02197078|147320460|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||||0.97|0.60|
73893780|NCT02197078|147320461|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.58|1.38||||||||1.38|0.58|
73893781|NCT02197078|147320461|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.6|1.64||||||||1.64|0.60|
73893782|NCT02197078|147320461|OTHER||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.24|0.78||||||||0.78|0.24|
73893783|NCT02197078|147320461|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.73|1.25||||||||1.25|0.73|
73893784|NCT02197078|147320461|OTHER||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.78|1.52||||||||1.52|0.78|
73893785|NCT02197078|147320461|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.05||||||||1.05|0.52|
73800403|NCT05085834|147149672|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.69|TWO_SIDED|95.0|-0.21|0.32|||v|||effect of Zinc supplementation on ln(LBP (ng/mL))||0.32|-0.21|0.69
73800404|NCT05085834|147149672|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.49|TWO_SIDED|95.0|-0.16|0.34|||linear combination of coefficients|||effect of Zinc supplementation on ln(Zonulin (ng/mL)||0.34|-0.16|0.49
73800405|NCT05842967|147149678|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|GMR|1.57|||||TWO_SIDED|95.0|1.396|1.759|||||GMRs (ratio of GMTs from C3671023 SSA to C3671013 immunogenicity subset), 2-sided CI were calculated by exponentiating difference in LS means, corresponding CIs based on regression model. Data reported here is for RSV A.|||1.759|1.396|
73800406|NCT05842967|147149678|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|GMR|1.52|||||TWO_SIDED|95.0|1.333|1.725|||||GMRs (ratio of GMTs from C3671023 SSA to C3671013 immunogenicity subset), 2-sided CI were calculated by exponentiating difference in LS means, corresponding CIs based on regression model. Data reported here is for RSV B.|||1.725|1.333|
73800407|NCT05842967|147149679|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|Difference in percentage|5.1|||||TWO_SIDED|95.0|1.2|9.2|||||Difference (C3671023 SSA, compared to C3671013 immunogenicity subset) in proportions, expressed as a percentage; 95% CIs for percentage difference were calculated using exact method based on Miettinen and Nurminen. Data reported here is for RSV A.|||9.2|1.2|
73800408|NCT05842967|147149679|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|Difference in percentage|8.3|||||TWO_SIDED|95.0|4.2|12.6|||||Difference (C3671023 SSA, compared to C3671013 immunogenicity subset) in proportions, expressed as a percentage; 95% CIs for percentage difference were calculated using exact method based on Miettinen and Nurminen. Data reported here is for RSV B.|||12.6|4.2|
73893786|NCT02197078|147320462|OTHER||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|1.1|2.18||||||||2.18|1.10|
73893787|NCT02197078|147320462|OTHER||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|1.19|3.03||||||||3.03|1.19|
73893788|NCT02197078|147320462|OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.73|1.68||||||||1.68|0.73|
73800409|NCT02547428|147149704|SUPERIORITY||Treatment difference|-8.1|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-11.0|-5.1|||ANCOVA||Sample size of 60 participants (30 per treatment sequence) was needed to provide minimum 85% power to detect 5 point difference between treatments at a 2-sided significance level of 5% using a paired t-test.|Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR and placebo. The analysis of covariance (ANCOVA) model included terms for period, sequence, and treatment as fixed effects, and Baseline score as a covariate, and a participate-within-sequence term as a random effect.||-5.1|-11.0|<0.001
73800410|NCT02547428|147149705|SUPERIORITY||Treatment difference|-7.1|STANDARD_ERROR_OF_MEAN|1.74|<|0.001|TWO_SIDED|95.0|-10.7|-3.6|||ANCOVA|||Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR 400 mg/day and placebo.||-3.6|-10.7|<0.001
73800411|NCT01479465|147149726|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.0395|TWO_SIDED|95.0|1.01|2.06|||Log Rank|||"The null hypothesis was that the hazard ratio (HR) equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% confidence interval \[CI\]) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level Eastern Cooperative Oncology Group (ECOG) performance status (0 or \> 0) at randomization."||2.06|1.01|0.0395
73800412|NCT01479465|147149726|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.1042|TWO_SIDED|95.0|0.92|1.89|||Log Rank|||"The null hypothesis was that the HR equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% CI) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level ECOG performance status (0 or \> 0) at randomization."||1.89|0.92|0.1042
73893789|NCT02197078|147320462|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.76|1.29||||||||1.29|0.76|
73893790|NCT02197078|147320462|OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.77|1.56||||||||1.56|0.77|
73893791|NCT02197078|147320462|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.54|1.14||||||||1.14|0.54|
73893792|NCT02197078|147320463|OTHER||Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.97|2.0||||||||2.00|0.97|
73893793|NCT02197078|147320463|OTHER||Hazard Ratio (HR)|1.71|||||TWO_SIDED|95.0|1.07|2.72||||||||2.72|1.07|
73893794|NCT02197078|147320463|OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.75|1.79||||||||1.79|0.75|
73893795|NCT02197078|147320463|OTHER||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|1.01|1.76||||||||1.76|1.01|
73893796|NCT02197078|147320463|OTHER||Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|1.02|2.27||||||||2.27|1.02|
73893797|NCT02197078|147320463|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.81|1.71||||||||1.71|0.81|
73893798|NCT02197078|147320464|OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|1.04|1.47||||||||1.47|1.04|
73893799|NCT02197078|147320464|OTHER||Hazard Ratio (HR)|1.31|||||TWO_SIDED|95.0|1.06|1.61||||||||1.61|1.06|
73893800|NCT02197078|147320464|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
73893801|NCT02197078|147320464|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
73893802|NCT02197078|147320464|OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.9|1.27||||||||1.27|0.90|
73893803|NCT02197078|147320464|OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.75|1.09||||||||1.09|0.75|
73893804|NCT02197078|147320465|OTHER||Hazard Ratio (HR)|1.62|||||TWO_SIDED|95.0|0.64|4.06||||||||4.06|0.64|
73800413|NCT06192589|147149734|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.43|||<|0.01|TWO_SIDED|90.0|1.34|1.52||Analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of cannabidiol on citalopram compared to citalopram alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.52|1.34|<0.01
73800414|NCT06192589|147149735|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12|||<|0.01|TWO_SIDED|90.0|1.06|1.17||Analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of cannabidiol on citalopram compared to citalopram alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.17|1.06|<0.01
73800415|NCT06192589|147149736|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.34|TWO_SIDED|90.0|0.96|1.16|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.16|0.96|0.34
73800416|NCT06192589|147149736|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12||||0.1|TWO_SIDED|90.0|1.0|1.26|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect.||1.26|1.00|0.10
73800417|NCT06192589|147149737|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.19||||0.02|TWO_SIDED|90.0|1.05|1.35|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.35|1.05|0.02
73800418|NCT06192589|147149737|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.11||||0.29|TWO_SIDED|90.0|0.94|1.3|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.30|0.94|0.29
73800419|NCT06192589|147149744|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.01||||0.47|TWO_SIDED|90.0|0.98|1.05|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.05|0.98|0.47
73800420|NCT06192589|147149744|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|0.99||||0.73|TWO_SIDED|90.0|0.96|1.03|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.03|0.96|0.73
73800421|NCT06192589|147149745|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12||||0.03|TWO_SIDED|90.0|1.03|1.21|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.21|1.03|0.03
73800422|NCT06192589|147149745|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|0.98||||0.66|TWO_SIDED|90.0|0.91|1.06|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.06|0.91|0.66
73800423|NCT06192589|147149746|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies.|Geometric mean ratio|1.08||||0.13|TWO_SIDED|90.0|0.99|1.18|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect.||1.18|0.99|0.13
73800424|NCT06192589|147149746|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.26|||<|0.01|TWO_SIDED|90.0|1.17|1.36|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.36|1.17|<0.01
73893805|NCT02197078|147320465|OTHER||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.61|4.58||||||||4.58|0.61|
73893806|NCT02197078|147320465|OTHER||Hazard Ratio (HR)|1.84|||||TWO_SIDED|95.0|0.62|5.48||||||||5.48|0.62|
73893807|NCT02197078|147320465|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.57|2.4||||||||2.40|0.57|
73893808|NCT02197078|147320465|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.38|2.43||||||||2.43|0.38|
73800425|NCT06192589|147149747|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.08||||0.12|TWO_SIDED|90.0|1.0|1.17|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.17|1.00|0.12
73800426|NCT06192589|147149747|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.11||||0.07|TWO_SIDED|90.0|1.01|1.21|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.21|1.01|0.07
73800427|NCT02717507|147149748|OTHER||Slope|0.163|STANDARD_ERROR_OF_MEAN|0.112||0.15|TWO_SIDED|95.0|-0.057|0.383|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVWT/Dz was statistically significant at a two-sided p\<0.05 and the expected LVWT/Dz was higher for carvedilol than placebo over time.|The null hypothesis is that change in LVWT/Dz across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 0.6-0.8 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVWT/Dz at 24m.||0.383|-0.057|0.15
73800428|NCT02717507|147149749|OTHER||Slope|-3.764|STANDARD_ERROR_OF_MEAN|1.705||0.03|TWO_SIDED|95.0|-7.105|-0.424|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||-0.424|-7.105|0.03
73800429|NCT02717507|147149750|OTHER||Slope|-0.045|STANDARD_ERROR_OF_MEAN|0.023||0.05|TWO_SIDED|95.0|-0.09|0.001|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.001|-0.09|0.05
73800430|NCT02717507|147149751|OTHER||Slope|-2.194|STANDARD_ERROR_OF_MEAN|1.605||0.17|TWO_SIDED|95.0|-5.34|0.951|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVESV was statistically significant at a two-sided p\<0.05 and the expected LVESV was lower for carvedilol than placebo over time.|||0.951|-5.34|0.17
73800431|NCT02717507|147149752|OTHER||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.01|TWO_SIDED|95.0|-141.0|-0.024|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||-0.024|-0141|0.01
73800432|NCT02717507|147149753|OTHER||Slope|-2.397|STANDARD_ERROR_OF_MEAN|2.603||0.36|TWO_SIDED|95.0|-7.499|2.704|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVEDV was statistically significant at a two-sided p\<0.05 and the expected LVEDV was lower for carvedilol than placebo over time.|||2.704|-7.499|0.36
73800433|NCT02717507|147149754|OTHER||Slope|0.433|STANDARD_ERROR_OF_MEAN|0.799||0.59|TWO_SIDED|95.0|-1.134|1.999|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||1.999|-1.134|0.59
73800434|NCT02717507|147149755|OTHER||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.302||0.84|TWO_SIDED|95.0|-0.652|0.532|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is positive|||0.532|-0.652|0.84
73800435|NCT02717507|147149756|OTHER||Slope|0.259|STANDARD_ERROR_OF_MEAN|0.373||0.49|TWO_SIDED|95.0|-0.472|0.991|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVEF was statistically significant at a two-sided p\<0.05 and the expected LVEF was higher for carvedilol than placebo over time.|The null hypothesis is that change in LVEF across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 1.2-1.6 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVEF at 24m.||0.991|-0.472|0.49
73800436|NCT02717507|147149757|OTHER||Slope|0.009|STANDARD_ERROR_OF_MEAN|0.038||0.82|TWO_SIDED|95.0|-0.065|0.082|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.082|-0.065|0.82
73800437|NCT02717507|147149758|OTHER||Slope|2.121|STANDARD_ERROR_OF_MEAN|1.79||0.24|TWO_SIDED|95.0|-1.387|5.63|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative|||5.63|-1.387|0.24
73893809|NCT02197078|147320465|OTHER||Hazard Ratio (HR)|1.65|||||TWO_SIDED|95.0|0.64|4.27||||||||4.27|0.64|
73893810|NCT03679754|147320543|OTHER||||||||||||||||||Subjects in the Expansion trial did not have biopsies analyzed for cellular responses.|||
73893811|NCT01640834|147320592|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.84||||0.0542|TWO_SIDED|95.0|-11.82|0.14|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.||0.14|-11.82|0.0542
73893812|NCT01640834|147320592|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.89||||0.0826|TWO_SIDED|95.0|-14.95|1.16|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group.||1.16|-14.95|0.0826
73893813|NCT01640834|147320593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.0||||0.046|TWO_SIDED|95.0|-33.7|-0.4|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.||-0.4|-33.7|0.0460
73893814|NCT01640834|147320593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.6||||0.0192|TWO_SIDED|95.0|-35.0|-4.3|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group using a 1 sample t-test.||-4.3|-35.0|0.0192
73893815|NCT01640834|147320598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.0||||0.0187|TWO_SIDED|95.0|-82.0|-9.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).||-9|-82|0.0187
73893816|NCT01640834|147320598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-59.0||||0.0048|TWO_SIDED|95.0|-96.0|-23.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).||-23|-96|0.0048
73893817|NCT01640834|147320599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4423.0||||0.0278|TWO_SIDED|95.0|-8256.0|-590.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).||-590|-8256|0.0278
73893818|NCT01640834|147320599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5187.0||||0.0046|TWO_SIDED|95.0|-8371.0|-2004.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).||-2004|-8371|0.0046
73893819|NCT01309282|147320600|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0078
73800438|NCT02717507|147149759|OTHER||Slope|5.113|STANDARD_ERROR_OF_MEAN|8.532||0.55|TWO_SIDED|95.0|-11.608|21.835|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative|||21.835|-11.608|0.55
73800439|NCT02717507|147149760|OTHER||Slope|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.51|TWO_SIDED|95.0|-0.004|0.002|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.002|-0.004|0.51
73800440|NCT02717507|147149761|OTHER||Slope|-0.022|STANDARD_ERROR_OF_MEAN|0.228||0.92|TWO_SIDED|95.0|-0.468|0.424|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.424|-0.468|0.92
73800441|NCT02717507|147149763|OTHER||Slope|0.024|STANDARD_ERROR_OF_MEAN|0.104||0.82|TWO_SIDED|95.0|-0.18|0.229|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.|||0.229|-0.18|0.82
73893820|NCT01309282|147320601|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0078
73893821|NCT01309282|147320602|SUPERIORITY_OR_OTHER|||||||0.01403|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.01403
73800442|NCT02717507|147149764|OTHER||Slope|-0.096|STANDARD_ERROR_OF_MEAN|2.439||0.97|TWO_SIDED|95.0|-4.877|4.685|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||4.685|-4.877|0.97
73800443|NCT02717507|147149765|OTHER||Slope|1.248|STANDARD_ERROR_OF_MEAN|3.491||0.72|TWO_SIDED|95.0|-5.595|8.091|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.|The null hypothesis is that change in Average Alanine aminotransferase across time-points described above does not differ by treatment arm, tested using a longitudinal GEE analysis of Average Alanine aminotransferase with a treatment by time interaction.||8.091|-5.595|0.72
73800444|NCT01866826|147149771|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
73800445|NCT01866826|147149772|SUPERIORITY|||||||||||||||||We calculated the proportion of pts with elevated viral levels \>50 copies/ml at each phase of the study.|We estimated that four of the seven patients would have an elevation in viral Ribonucleic Acid (RNA) level \>50 copies/ml.|||
73800446|NCT01866826|147149774|SUPERIORITY||Mean Difference (Net)|0.7872|||||TWO_SIDED|||||||||We calculated the percentage of total lymphocytes that were expressing activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the Wilcoxon test to detect differences between the differences in percentages in the control and Rifaximin groups.||||
73893822|NCT01309282|147320603|SUPERIORITY_OR_OTHER|||||||0.0355|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0355
73893823|NCT01309282|147320604|SUPERIORITY_OR_OTHER|||||||0.5469|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.5469
73893824|NCT01309282|147320605|SUPERIORITY_OR_OTHER|||||||0.0225|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0225
73893825|NCT01309282|147320606|SUPERIORITY_OR_OTHER|||||||0.0225|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0225
73893826|NCT01309282|147320607|SUPERIORITY_OR_OTHER|||||||0.0904|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0904
73893827|NCT01309282|147320608|SUPERIORITY_OR_OTHER|||||||0.2969|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.2969
73893828|NCT05661851|147320631|NON_INFERIORITY|Non-inferiority margin of -20 was used.|Least-square Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|3.79|||TWO_SIDED|95.0|-1.67|13.38|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control.|A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.||13.38|-1.67|
73893829|NCT05661851|147320632|NON_INFERIORITY|Non-inferiority margin of -20 was used.|Mean Population Difference Estimate|5.843|STANDARD_ERROR_OF_MEAN|4.456|||TWO_SIDED|95.0|-2.8904|14.5768|||Bootstrapping methods||Bootstrap Mean Difference was calculated as Test minus Control|A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.||14.5768|-2.8904|
73893830|NCT00612807|147320633|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|-0.56|STANDARD_ERROR_OF_MEAN|0.29||0.056||95.0||||Interaction indicates that slope of change varied by identified patient status and tx condition. Slope of change in depression was significantly negative for everyone but identified patients in the control condition.|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.056
73893831|NCT00612807|147320634|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|0.64|STANDARD_ERROR_OF_MEAN|0.65||0.32||95.0|||||Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.32
73893832|NCT00612807|147320634|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether means at each timepoint varied by identified patient status and treatment condition.|Interaction term|-12.97|STANDARD_ERROR_OF_MEAN|4.52||0.005||95.0||||We probed this interaction and discovered that at each assessment, spouses in the couple therapy + medication treatment group reported greater dyadic adjustment than did spouses in the medication alone condition (b = 10.53, z = 2.72, p = 0.006).|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.005
73893833|NCT02055118|147320644|SUPERIORITY||Least squares mean|3.0|STANDARD_ERROR_OF_MEAN|5.12||0.5669|TWO_SIDED|95.0|-7.3|13.3|||Mixed model repeated measures|||The Mixed model repeated measures included fixed categorical effects for treatment, visit week, treatment by visit week interaction, baseline GCA classification factor (less than or equal to \[\<=\] 70 or \>70), baseline age group (\<6 years or \>=6 years), treatment by baseline GCA classification factor interaction, treatment by baseline age group interaction, interaction between baseline GCA classification factor and baseline age group, genotype, and the baseline GCA score as a continuous covariate.||13.3|-7.3|0.5669
73893834|NCT02259088|147320678|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.8|||<|0.001|TWO_SIDED|95.0|4.1|7.5|||Cochran-Mantel-Haenszel|One-sided p-value for treatment difference is derived from the two-sided stratified Cochran-Mantel-Haenszel test using the row means score statistics.|Estimated from ANOVA (stratified) model. Stratified analysis includes DME type (focal, diffuse, honeycomb and petaloid) and Baseline BCVA(≤ 60 letters and \> 60 letters) as factors.|||7.5|4.1|<0.001
73800447|NCT01866826|147149774|SUPERIORITY|||||||0.54|||||||Wilcoxon|||We calculated the percentage of total lymphocytes that were expressing the activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the T-test to detect differences between the differences in percentages in the control group and Rifaximin groups.||||0.54
73893835|NCT00329524|147320700|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis based on paired t-test.|||||<|0.05||95.0|||||t-test, 2 sided|||||||<.05
73893836|NCT00329524|147320701|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||test for order effect|||||||.05
73893837|NCT01001325|147320703|SUPERIORITY_OR_OTHER|||||||0.685||95.0|||||Fisher Exact|||"Null hypothesis: There is no difference in incidence of pandemic strain influenza infection for people given seasonal influenza vaccine compared to those given a placebo.~Power to detect a 2-fold difference if attack rate in non-vaccinated participants is 10%: 86%"||||0.685
73800448|NCT00742209|147149786|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|0.3||||0.579|TWO_SIDED|95.0|-0.6|1.1||A combination of a sequential method and the Hochberg procedure has been used to maintain the overall experiment-size alphas level of 0.05 for the comparison of GEn vs. placebo.|ANCOVA|An ANCOVA model with baseline number of MHD and IHS Headache Classification for presence or absence of aura as covariates was used.|Adjusted mean difference versus placebo|||1.1|-0.6|0.579
73893838|NCT01584440|147320704|SUPERIORITY||Ordinary Least Squares (OLS) Z-statistic|-1.5|||<=|0.001|TWO_SIDED||||||ANCOVA|Sequential Parallel Comparison Design (SPCD): data from the Stages 1 and 2 are analyzed together using the mITT Population||||||<=0.001
73893839|NCT01584440|147320704|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.5|||||TWO_SIDED||||||||Day 36|||||
73893840|NCT01584440|147320704|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.59|||||TWO_SIDED||||||||Day 70|||||
73893841|NCT01584440|147320706|SUPERIORITY||OLS Z-statistic|-2.46||||0.014|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.014
73800449|NCT02562066|147149805|OTHER||Mean Difference (Net)|1.63||||0.085|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.085
73893842|NCT01584440|147320706|SUPERIORITY||ANCOVA Least Squares Mean Difference|-4.2|||||TWO_SIDED||||||||||Day 36|||
73800450|NCT02562066|147149805|OTHER||Mean Difference (Net)|0.56|||||TWO_SIDED|95.0|-0.97|2.09|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with SGI raw scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||2.09|-0.97|
73800451|NCT02562066|147149806|OTHER||Mean Difference (Net)|3.17||||0.376|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.376
73800452|NCT02562066|147149806|OTHER||Mean Difference (Net)|1.14|||||TWO_SIDED|95.0|-2.31|4.58|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with Overall MFM-32 scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||4.58|-2.31|
73800453|NCT02562066|147149807|OTHER||Mean Difference (Net)|-1.0||||0.8|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.800
73800454|NCT02562066|147149807|OTHER||Mean Difference (Net)|0.63|||||TWO_SIDED|95.0|-5.25|6.5|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with Overall MFM-20 scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||6.50|-5.25|
73800455|NCT01998919|147149833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.34|||||TWO_SIDED|95.0|-10.3|17.0|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||17.0|-10.3|
73800456|NCT01998919|147149834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.63|||||TWO_SIDED|95.0|-5.6|26.8|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||26.8|-5.6|
73800457|NCT01998919|147149835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.48|||||TWO_SIDED|95.0|-2.7|27.7|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||27.7|-2.7|
73800458|NCT01998919|147149836|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Log Rank|||||||0.0075
73800459|NCT01998919|147149836|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.0099|TWO_SIDED|95.0|0.22|0.81|||Wald test|||||0.81|0.22|0.0099
73800460|NCT01998919|147149837|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Log Rank|||||||0.0004
73800461|NCT01998919|147149837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48||||0.0001|TWO_SIDED|95.0|0.33|0.7|||Wald Test|||||0.70|0.33|0.0001
73800462|NCT01998919|147149838|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|||||||0.0001
73800463|NCT01998919|147149838|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.68|||Wald test|||||0.68|0.33|<0.0001
73800464|NCT01998919|147149839|SUPERIORITY_OR_OTHER|||||||0.5991|||||||Log Rank|||||||0.5991
73800465|NCT01998919|147149839|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3774|TWO_SIDED|95.0|0.58|1.23|||Wald test|||||1.23|0.58|0.3774
73800466|NCT00897715|147149842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED|||||0.05 is the a priori threshold for statistical significance|ANCOVA|||For the primary specific aim, we will compare the mean percent change on hsCRP between the intervention arm and the placebo arm using linear regression. We anticipate that the intervention will conservatively decrease hsCRP by 54%; whereas, placebo will have no effect. Accordingly, we have estimated that we will need 24 subjects in the experimental arm and 24 controls to have an 80% power, with an alpha of 0.05 to detect the above mentioned effect size.||||0.03
73800467|NCT00897715|147149843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||0.05 is the a priori threshold for statistical significance|ANCOVA|||||||0.01
73800468|NCT00776035|147149859|SUPERIORITY||||||<|0.005|||||||Student's t-test|||Average myocardial blood flow, men versus women||||<0.005
73800469|NCT00776035|147149860|SUPERIORITY||||||<|0.05|||||||Student's t-test|||Average myocardial fatty acid utilization, men versus women||||<0.05
73800470|NCT00791778|147149861|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.655|TWO_SIDED|95.0|0.72|1.63|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo|Sample size based on the primary efficacy endpoint of PFS. Clinically meaningful improvement defined as 65% increase in median PFS. With one-sided alpha of 0.10, power of 90% and a randomization ratio of 1:1 between Sorafenib and Placebo, a total of 105 PFS events were required.||1.63|0.72|0.655
73800471|NCT00791778|147149862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.951|TWO_SIDED|95.0|0.93|2.2|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo|||2.20|0.93|0.951
73800472|NCT00791778|147149863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.84|TWO_SIDED|95.0|0.69|3.23|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization.|Sorafenib compared to Placebo|||3.23|0.69|0.84
73800473|NCT03335475|147149885|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
73800474|NCT03335475|147149886|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
73800475|NCT03335475|147149887|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
73800476|NCT05921903|147149895|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|3.52|||||TWO_SIDED|95.0|2.26|5.48|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 2.||5.48|2.26|
73800477|NCT05921903|147149895|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.28|2.04|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 3.||2.04|1.28|
73800478|NCT05921903|147149896|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.26|||||TWO_SIDED|95.0|0.94|1.69|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_IC\_2/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). ANCOVA model included the group as fixed effect, and SOT type and baseline log10-transformed titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-A strain at Visit 4.||1.69|0.94|
73800479|NCT05921903|147149897|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.31|||||TWO_SIDED|95.0|1.01|1.68|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.||1.68|1.01|
73800480|NCT05921903|147149898|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.8|1.3|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_2) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.||1.30|0.80|
73800481|NCT05921903|147149900|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|3.37|||||TWO_SIDED|95.0|2.28|4.98|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 2.||4.98|2.28|
73800482|NCT05921903|147149900|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.67|||||TWO_SIDED|95.0|1.32|2.13|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 3.||2.13|1.32|
73800483|NCT05921903|147149901|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.28|||||TWO_SIDED|95.0|0.97|1.7|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_IC\_2/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). ANCOVA model included the group as fixed effect, and SOT type and baseline log10-transformed titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-B strain at Visit 4.||1.70|0.97|
73800484|NCT05921903|147149902|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.29|||||TWO_SIDED|95.0|1.0|1.65|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.||1.65|1.00|
73800485|NCT05921903|147149903|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.01|||||TWO_SIDED|95.0|0.8|1.26|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_2) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.||1.26|0.80|
73893843|NCT01584440|147320706|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.78|||||TWO_SIDED||||||||Day 70|||||
73893844|NCT01584440|147320707|SUPERIORITY||OLS Z-statistic|0.77||||0.444|TWO_SIDED||||||ANCOVA|Delusions Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.444
73893845|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.27|||||TWO_SIDED||||||||Delusions Domain; Day 36|||||
73893846|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.78|||||TWO_SIDED||||||||Delusions Domain; Day 70|||||
73800486|NCT05317312|147149921|SUPERIORITY||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|12.08||0.123|TWO_SIDED|95.0|-5.2|42.7|||Emax||The estimated difference between 1.25mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|||42.7|-5.2|0.123
73800487|NCT05317312|147149921|SUPERIORITY||Mean Difference (Final Values)|34.7|STANDARD_ERROR_OF_MEAN|10.25|<|0.001|TWO_SIDED|95.0|14.4|55.0|||Emax||||The estimated difference between 5mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|55.0|14.4|<0.001
73800488|NCT05317312|147149921|SUPERIORITY||Mean Difference (Final Values)|42.8|STANDARD_ERROR_OF_MEAN|9.53|<|0.001|TWO_SIDED|95.0|23.9|61.7|||Emax||The estimated difference between 15mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|||61.7|23.9|<0.001
73800489|NCT05317312|147149922|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.0|0.2|||||The estimated difference between 1.5mg bid and placebo is based on Mixed Model Repeated Measures.The values in the Outcome Measure Data are observed mean values.|||0.2|-2.0|
73800490|NCT05317312|147149922|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-1.8|0.4|||||The estimated difference between 5mg bid and placebo is based on Mixed Model Repeated Measures. The values in the Outcome Measure Data are observed mean values|||0.4|-1.8|
73800491|NCT05317312|147149922|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-1.9|0.3|||||The estimated difference between 15mg bid and placebo is based on Mixed Model Repeated Measures.. The values in the Outcome Measure Data are observed mean values|||0.3|-1.9|
73800492|NCT05317312|147149923|SUPERIORITY|||||||0.036|||||||Log Rank|||||||0.036
73800493|NCT05317312|147149923|SUPERIORITY|||||||0.006|||||||Log Rank|||||||0.006
73800494|NCT05317312|147149923|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
73800495|NCT05317312|147149924|SUPERIORITY|||||||0.411|||||||Log Rank|||||||0.411
73800496|NCT05317312|147149924|SUPERIORITY|||||||0.383|||||||Log Rank|||||||0.383
73800497|NCT05317312|147149924|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
73800498|NCT05317312|147149925|SUPERIORITY||Risk Difference (RD)|27.4||||0.042|TWO_SIDED|95.0|2.0|52.7|||Chi-squared|||||52.7|2.0|0.042
73800499|NCT05317312|147149925|SUPERIORITY||Risk Difference (RD)|34.5||||0.01|TWO_SIDED|95.0|9.7|59.3|||Chi-squared|||||59.3|9.7|0.01
73800500|NCT05317312|147149925|SUPERIORITY||Risk Difference (RD)|51.9|||<|0.001|TWO_SIDED|95.0|29.6|74.1|||Chi-squared|||||74.1|29.6|<0.001
73800501|NCT05317312|147149926|SUPERIORITY||Risk Difference (RD)|-31.2||||0.019|TWO_SIDED|95.0|-55.9|-6.5|||Chi-squared|||||-6.5|-55.9|0.019
73800502|NCT05317312|147149926|SUPERIORITY||Risk Difference (RD)|-16.9||||0.187|TWO_SIDED|95.0|-41.6|7.8|||Chi-squared|||||7.8|-41.6|0.187
73800503|NCT05317312|147149926|SUPERIORITY||Risk Difference (RD)|-44.4||||0.001|TWO_SIDED|95.0|-68.3|20.6|||Chi-squared|||||20.6|-68.3|0.001
73800504|NCT00235755|147149927|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||<0.001
73800505|NCT00235755|147149927|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||0.007
73800506|NCT00235755|147149928|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73800507|NCT00235755|147149928|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73800508|NCT01532934|147149950|SUPERIORITY_OR_OTHER|||||||0.02||||||As stated, the p-value reflects the Factor 1 by treatment interaction term and its effect on percent days abstinent/month.|Regression, Linear|||A priori hypothesis. Psychopathy Factor 1 (F1) X treatment interaction to predict higher substance use among people high in F1 + who get treatment relative to individuals with high F1 who get standard care.||||.02
73800509|NCT01532934|147149951|SUPERIORITY_OR_OTHER|||||||0.34||||||As stated, the p-value reflects the F1 X treatment interaction term and its effect on substance use consequences. A priori threshold for significance was p\<.05.|Regression, Linear|||Experimental hypothesis: The F1 X treatment interaction will show that individuals low on F1 who get treatment will reduce substance use consequences at six months relative to those low on F1 who get standard care.||||.34
73800510|NCT01532934|147149952|SUPERIORITY_OR_OTHER|||||||0.69||||||a priori threshold p\<.05|Regression, Logistic|||Experimental hypothesis: Treatment X F1 interaction will predict fewer charges at one-year follow-up for individuals low on F1 who got treatment relative to individuals low on F1 who did not.||||.69
73800511|NCT02291237|147149953|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.55||||0.416|TWO_SIDED|95.0|-1.87|0.78|||ANCOVA|P-value and Least Squares (LS) Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.||The analysis evaluated the change in Peak VO2 from baseline to Week 24 for the eleclazine group compared with that of the placebo group using analysis of covariance (ANCOVA) including terms for baseline Peak VO2, sex, and age (continuous).||0.78|-1.87|0.416
73800512|NCT02291237|147149954|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.42||||0.517|TWO_SIDED|95.0|-1.68|0.85||P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.|ANCOVA|||The analysis evaluated the change in Peak VO2 from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline Peak VO2, sex, and age (continuous).||0.85|-1.68|0.517
73800513|NCT02291237|147149955|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|1.54||||0.513|TWO_SIDED|95.0|-3.11|6.19|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||6.19|-3.11|0.513
73800514|NCT02291237|147149956|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|0.1||||0.964|TWO_SIDED|95.0|-4.36|4.56|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||4.56|-4.36|0.964
73893847|NCT01584440|147320707|SUPERIORITY||OLS Z-statistic|-0.18||||0.861|TWO_SIDED||||||ANCOVA|Hallucinations Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.861
73893848|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.29|||||TWO_SIDED||||||||Hallucinations Domain; Day 36|||||
73893849|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.22|||||TWO_SIDED||||||||Hallucinations Domain; Day 70|||||
73893850|NCT01584440|147320707|SUPERIORITY||OLS Z-statistic|-0.32||||0.749|TWO_SIDED||||||ANCOVA|Depression/Dysphoria Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.749
73893851|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.07|||||TWO_SIDED||||||||Depression/Dysphoria Domain; Day 36|||||
73893852|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.1|||||TWO_SIDED||||||||Depression/Dysphoria Domain; Day 70|||||
73893853|NCT01584440|147320707|SUPERIORITY||OLS Z-statistic|-0.81||||0.416|TWO_SIDED||||||ANCOVA|Anxiety Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.416
73893854|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.28|||||TWO_SIDED||||||||Anxiety Domain; Day 36|||||
73893855|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.81|||||TWO_SIDED||||||||Anxiety Domain|||||
73893856|NCT01584440|147320707|SUPERIORITY||OLS Z-statistic|-1.07||||0.287|TWO_SIDED||||||ANCOVA|Euphoria/Elation Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.287
73800515|NCT02291237|147149957|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.04||||0.944|TWO_SIDED|95.0|-1.18|1.1|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||1.10|-1.18|0.944
73800516|NCT02291237|147149958|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|0.0||||0.993|TWO_SIDED|95.0|-0.96|0.97|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||0.97|-0.96|0.993
73800517|NCT00699998|147149989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.915||||0.21|TWO_SIDED|95.0|0.793|1.055||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.055|0.793|0.210
73893857|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.04|||||TWO_SIDED||||||||Euphoria/Elation Domain; Day 36|||||
73893858|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.34|||||TWO_SIDED||||||||Euphoria/Elation Domain; Day 70|||||
73800518|NCT00699998|147149989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.029||||0.731|TWO_SIDED|95.0|0.865|1.225||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.225|0.865|0.731
73893859|NCT01584440|147320707|SUPERIORITY||OLS Z-statistic|-1.31||||0.191|TWO_SIDED||||||ANCOVA|Apathy/Indifference Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.191
73893860|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.16|||||TWO_SIDED||||||||Apathy/Indifference Domain; Day 36|||||
73893861|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.77|||||TWO_SIDED||||||||Apathy/Indifference Domain; Day 36|||||
73893862|NCT01584440|147320707|SUPERIORITY||OLS Z-statistic|-1.1||||0.271|TWO_SIDED||||||ANCOVA|Disinhibition Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.271
73893863|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.22|||||TWO_SIDED||||||||Disinhibition Domain; Day 36|||||
73893864|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.37|||||TWO_SIDED||||||||Disinhibition Domain; Day 70|||||
73893865|NCT01584440|147320707|SUPERIORITY||OLS Z-statistic|-2.18||||0.029|TWO_SIDED||||||ANCOVA|Irritability/Lability Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.029
73893866|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.7|||||TWO_SIDED||||||||Irritability/Lability Domain; Day 36|||||
73893867|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.93|||||TWO_SIDED||||||||Irritability/Lability Domain; Day 70|||||
73893868|NCT01584440|147320707|SUPERIORITY||OLS Z-statistic|-2.21||||0.027|TWO_SIDED||||||ANCOVA|Aberrant Motor Behavior Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.027
73893869|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.38|||||TWO_SIDED||||||||Aberrant Motor Behavior Domain; Day 36|||||
73893870|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.22|||||TWO_SIDED||||||||Aberrant Motor Behavior Domain; Day 70|||||
73893871|NCT01584440|147320707|SUPERIORITY||OLS Z-statistic|-1.09||||0.274|TWO_SIDED||||||ANCOVA|Sleep/Nighttime Behavior Disorders Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.274
73893872|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.57|||||TWO_SIDED||||||||Sleep/Nighttime Behavior disorders Domain; Day 36|||||
73893873|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.08|||||TWO_SIDED||||||||Sleep/Nighttime Behavior disorders Domain; Day 70|||||
73893874|NCT01584440|147320707|SUPERIORITY||OLS Z-statistic|-0.65||||0.513|TWO_SIDED||||||ANCOVA|Appetite/Eating Changes Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.513
73893875|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.16|||||TWO_SIDED||||||||Appetite/Eating Changes Domain; Day 36|||||
73893876|NCT01584440|147320707|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.24|||||TWO_SIDED||||||||Appetite/Eating Changes Domain; Day 70|||||
73893877|NCT01584440|147320708|SUPERIORITY||OLS Z-statistic|-3.53|||<=|0.001|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||<=0.001
73893878|NCT01584440|147320708|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.01|||||TWO_SIDED||||||||Day 36|||||
73893879|NCT01584440|147320708|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.49|||||TWO_SIDED||||||||Day 70|||||
73800519|NCT00699998|147149990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.388|TWO_SIDED|95.0|0.812|1.088|||Log Rank|Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.088|0.812|0.388
73800520|NCT00699998|147149990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.998||||0.99|TWO_SIDED|95.0|0.833|1.195||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.195|0.833|0.990
73800521|NCT00699998|147149991|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.353|TWO_SIDED|95.0|0.826|1.073||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.073|0.826|0.353
73800522|NCT00699998|147149991|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.029||||0.719|TWO_SIDED|95.0|0.869|1.218||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.218|0.869|0.719
73800523|NCT00699998|147149992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.27|TWO_SIDED|95.0|0.81|1.063||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.063|0.810|0.270
73800524|NCT00699998|147149992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017||||0.831|TWO_SIDED|95.0|0.862|1.2||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.200|0.862|0.831
73800525|NCT00699998|147149993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-100.208|||<|0.001|TWO_SIDED|95.0|-107.872|-92.545||p-value is for Day 30 comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for Day 30 comparison|||-92.545|-107.872|<0.001
73800526|NCT00699998|147149993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-104.475|||<|0.001|TWO_SIDED|95.0|-115.383|-93.566||p-value is for 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for 12 month comparison.|||-93.566|-115.383|<0.001
73800527|NCT00699998|147149993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.413|||<|0.001|TWO_SIDED|95.0|-63.718|-33.108||p-value is for 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 30 day comparison.|||-33.108|-63.718|<0.001
73800528|NCT00699998|147149993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.264|||<|0.001|TWO_SIDED|95.0|-69.061|-23.468||p-value is for the 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 12 month comparison.|||-23.468|-69.061|<0.001
73800529|NCT00699998|147149994|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|0.982||||0.631|TWO_SIDED|95.0|0.91|1.059||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.059|0.910|0.631
73800530|NCT00699998|147149994|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.01||||0.844|TWO_SIDED|95.0|0.916|1.113||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.113|0.916|0.844
73800531|NCT00699998|147149994|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.138||||0.098|TWO_SIDED|95.0|0.977|1.325||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.325|0.977|0.098
73800532|NCT00699998|147149994|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.066||||0.545|TWO_SIDED|95.0|0.867|1.31||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.310|0.867|0.545
73800533|NCT00699998|147149995|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.018||||0.727|TWO_SIDED|95.0|0.919|1.129||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.129|0.919|0.727
73800534|NCT00699998|147149995|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.057||||0.346|TWO_SIDED|95.0|0.942|1.187||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.187|0.942|0.346
73800535|NCT00699998|147149995|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.096||||0.458|TWO_SIDED|95.0|0.859|1.399||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.399|0.859|0.458
73800536|NCT00699998|147149995|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.033||||0.802|TWO_SIDED|95.0|0.803|1.329||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.329|0.803|0.802
73800537|NCT00699998|147149997|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||p-value is for the comparison of physical limitations at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.5
73800538|NCT00699998|147149997|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||p-value is for the comparison of angina frequency at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.72
73800539|NCT00699998|147149997|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||p-value is for the comparison of physical limitations at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.63
73800540|NCT00699998|147149997|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||p-value is for the comparison of angina frequency at at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.53
73800541|NCT00473590|147150005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.956||||0.9179|TWO_SIDED|95.0|0.404|2.261|||Log Rank|The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|The hazard ratios were estimated using Cox regression.|Stratified analysis||2.261|0.404|0.9179
73800542|NCT00473590|147150005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.836||||0.6665|TWO_SIDED|95.0|0.369|1.893||The tests were exploratory because patients were not randomized to the two arms with respect to response status.|Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis.||1.893|0.369|0.6665
73800543|NCT00473590|147150006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.633||||0.3134|TWO_SIDED|95.0|0.258|1.552|||Log Rank||The hazard ratios were estimated using Cox regression. The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|Stratified analysis||1.552|0.258|0.3134
73800544|NCT00473590|147150006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.608||||0.2634|TWO_SIDED|95.0|0.251|1.468|||Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis||1.468|0.251|0.2634
73800545|NCT00473590|147150007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.743||||0.2804|TWO_SIDED|95.0|0.432|1.276|||Log Rank|The analysis was stratified for number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to BORT + P.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the BORT + BV group. Stratified Analysis.||1.276|0.432|0.2804
73800546|NCT00473590|147150007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.713||||0.2009|TWO_SIDED|95.0|0.424|1.2|||Log Rank||Hazard ratio relative to BORT + P was estimated using Cox regression.|Unstratified Analysis.||1.200|0.424|0.2009
73800547|NCT00395161|147150009|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Log Rank|Two-sided logrank test was used, stratified by immune compromised status at study entry (a factor also used to stratify the study randomization)||Null hypothesis was equal median time in both arms. Sample size calculated to yield 90% power to detect a significant effect, assuming inverse hazard rate of 1.5 using two-sided logrank test with alpha=0.05. This required recruitment until 263 patients with an event were enrolled (though the study was terminated early for futility by the DSMB).||||0.29
73800548|NCT00395161|147150010|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Rate analysis (see comments)|95% CIs were calculated for rates in each arm, and rates compared between arms, via approach of DR Cox, Biometrika (1953), vol 40, pp. 354-60.||Null hypothesis of equal event rates in the two study arms.||||0.81
73800549|NCT00395161|147150011|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.09
73800550|NCT00395161|147150012|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Chi-squared|||||||0.07
73800551|NCT00395161|147150013|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Chi-squared|||||||0.16
73800552|NCT00725920|147150041|SUPERIORITY_OR_OTHER|||||||0.0076||95.0|||||t-test, 2 sided|||||||0.0076
73800553|NCT02546986|147150070|SUPERIORITY||Hazard Ratio (HR)|1.374||||0.1789|TWO_SIDED|90.0|0.926|2.038|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model|||2.038|0.926|0.1789
73800554|NCT02546986|147150071|SUPERIORITY||Disease Control Rate Difference|-13.3||||0.1572|TWO_SIDED|90.0|-29.0|3.5|||Cochran-Mantel-Haenszel|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma||||3.5|-29.0|0.1572
73800555|NCT02546986|147150072|SUPERIORITY||Hazard Ratio (HR)|1.375||||0.2968|TWO_SIDED|90.0|0.83|2.276|||Stratified Log Rank|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma).|Hazard ratio and associated 2-sided 90% CIs were estimated using Cox proportional hazard model.|||2.276|0.830|0.2968
73800556|NCT02546986|147150073|SUPERIORITY||Overall Response Rate (ORR) Difference|5.3|||||TWO_SIDED|90.0|-11.5|21.3|||||The 90% exact unconditional confidence interval was used for ORR difference.|||21.3|-11.5|
73800557|NCT02546986|147150075|SUPERIORITY||Hazard Ratio (HR)|1.352||||0.199|TWO_SIDED|90.0|0.914|2.0|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model|||2.000|0.914|0.1990
73800558|NCT05016960|147150087|OTHER|one group paired samples t test to compare scores at pre vs. post treatment||||||0.503|||||||t-test, 2 sided|||||||.503
73800559|NCT05016960|147150088|NON_INFERIORITY|one group paired samples t test||||||0.23|||||||t-test, 2 sided|||||||.230
73800560|NCT05016960|147150089|OTHER|one group paired samples t test||||||0.061|||||||t-test, 2 sided|||||||.061
73800561|NCT05016960|147150090|OTHER|one group paired samples t test|||||<|0.001|||||||t-test, 2 sided|||||||<.001
73800562|NCT05016960|147150091|OTHER|one group paired samples t test||||||0.01|||||||t-test, 2 sided|||||||.01
73800563|NCT05016960|147150092|OTHER|one group paired samples t test||||||0.625|||||||t-test, 2 sided|||||||.625
73800564|NCT05016960|147150093|OTHER|one group paired samples t test||||||0.134|||||||t-test, 2 sided|||||||.134
73800565|NCT05016960|147150094|OTHER|one group paired samples t test||||||0.515|||||||t-test, 2 sided|||||||.515
73800566|NCT05016960|147150095|OTHER|one group paired samples t test||||||0.41|||||||t-test, 2 sided|||||||.410
73800567|NCT05016960|147150096|OTHER|one group paired samples t test||||||0.706|||||||t-test, 2 sided|||||||.706
73800568|NCT05016960|147150097|OTHER|one group paired samples t test||||||0.062|||||||t-test, 2 sided|||||||.062
73800569|NCT05016960|147150098|OTHER|one group paired samples t test||||||0.39|||||||t-test, 2 sided|||||||.390
73800570|NCT05016960|147150099|OTHER|one group paired samples t test||||||0.38|||||||t-test, 2 sided|||||||.38
73800571|NCT05016960|147150100|OTHER|One group paired samples t test||||||0.064|||||||t-test, 2 sided|||||||.064
73800572|NCT04796961|147150101|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|0.1|0.7||||||||0.7|0.1|
73800573|NCT04796961|147150102|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-0.1|1.1||||||smoking screening||1.1|-0.1|
73800574|NCT04796961|147150102|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.1|1.2||||||readiness to quit assessments||1.2|-0.1|
73800575|NCT04796961|147150102|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|0.8|2.0||||||smoking cessation counseling||2.0|0.8|
73800576|NCT04796961|147150102|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.5|1.7||||||smoking cessation pharmacotherapy||1.7|-0.5|
73800577|NCT02513160|147150125|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|150.0|||<|0.0001|TWO_SIDED|95.0|86.8|213.2||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.||213.2|86.8|<0.0001
73800578|NCT02513160|147150125|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|144.0|||<|0.0001|TWO_SIDED|95.0|80.7|206.6||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.||206.6|80.7|<0.0001
73800579|NCT02513160|147150125|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|148.0|||<|0.0001|TWO_SIDED|95.0|84.7|211.4||a priori threshold for significance of 0.05. The p-value was not adjusted.|ANCOVA|Difference of LS means and 95% CI represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|||211.4|84.7|<0.0001
73800580|NCT02513160|147150126|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.9||||0.0003|TWO_SIDED|95.0|10.11|33.71||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Treatment comparisons began with am PEF for BAI 640 mcg/day vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BAI 640 mcg/day vs placebo 2) the am PEF for BAI 320 mcg/day vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||33.71|10.11|0.0003
73800581|NCT02513160|147150126|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|30.1|||<|0.0001|TWO_SIDED|95.0|18.33|41.9||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in previous analysis.||41.90|18.33|<0.0001
73800582|NCT02513160|147150126|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.0||||0.0006|TWO_SIDED|95.0|9.14|32.83||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||32.83|9.14|0.0006
73800583|NCT02513160|147150127|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|143.0|||<|0.0001|TWO_SIDED|95.0|71.7|214.1||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||214.1|71.7|<0.0001
73800584|NCT02513160|147150127|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|170.0|||<|0.0001|TWO_SIDED|95.0|98.5|240.5||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||240.5|98.5|<0.0001
73800585|NCT02513160|147150127|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|133.0||||0.0003|TWO_SIDED|95.0|61.3|204.3||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||204.3|61.3|0.0003
73800586|NCT02513160|147150128|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.408|-0.64||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.640|-1.408|<0.0001
73800587|NCT02513160|147150128|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.482|-0.717||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.717|-1.482|<0.0001
73800588|NCT02513160|147150128|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.03|||<|0.0001|TWO_SIDED|95.0|-1.415|-0.643||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||-0.643|-1.415|<0.0001
73800589|NCT02513160|147150129|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.44|-0.203||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.203|-0.440|<0.0001
73800590|NCT02513160|147150129|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.25|||<|0.0001|TWO_SIDED|95.0|-0.365|-0.128||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.128|-0.365|<0.0001
73800591|NCT02513160|147150129|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.423|-0.185||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||-0.185|-0.423|<0.0001
73893880|NCT01584440|147320709|SUPERIORITY||OLS Z-statistic|-3.34||||0.001|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.001
73893881|NCT01584440|147320709|SUPERIORITY||ANCOVA Least Squares Mean Difference|-2.41|||||TWO_SIDED||||||||Day 36|||||
73893882|NCT01584440|147320709|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.94|||||TWO_SIDED||||||||Day 70|||||
73893883|NCT01584440|147320710|SUPERIORITY||OLS Z-statistic|-2.46||||0.014|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.014
73893884|NCT01584440|147320710|SUPERIORITY||ANCOVA Least Squares Mean Difference|-2.65|||||TWO_SIDED||||||||Day 36|||||
73893885|NCT01584440|147320710|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.01|||||TWO_SIDED||||||||||Day 70|||
73893886|NCT01584440|147320711|SUPERIORITY||OLS Z-statistic|-2.57||||0.01|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.010
73800592|NCT02513160|147150130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0058|||||||Log Rank|||||||0.0058
73800593|NCT02513160|147150130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||Log Rank|||||||0.0014
73800594|NCT02513160|147150130|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062|||||||Log Rank|||||||0.0062
73893887|NCT01584440|147320711|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.68|||||TWO_SIDED||||||||Day 36|||||
73893888|NCT01584440|147320711|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.2|||||TWO_SIDED||||||||Day 70|||||
73893889|NCT01584440|147320712|SUPERIORITY||OLS Z-statistic|-3.08||||0.002|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.002
73893890|NCT01584440|147320712|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.56|||||TWO_SIDED||||||||Day 36|||||
73893891|NCT01584440|147320712|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.9|||||TWO_SIDED||||||||Day 70|||||
73893892|NCT01584440|147320713|SUPERIORITY||OLS Z-statistic|-2.66||||0.008|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.008
73800595|NCT05258773|147150147|SUPERIORITY||LS Mean difference Arm A - Arm B|-11.0||||0.1406|TWO_SIDED|95.0|-25.9|3.9||An analysis of covariance (ANCOVA) model was used to assess changes from baseline at 500Hz at the Day 49 visit comparing the treatment groups.The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||3.9|-25.9|0.1406
73800596|NCT05258773|147150147|SUPERIORITY||LS Mean difference Arm A - Arm B|-14.4||||0.0567|TWO_SIDED|95.0|-29.24|0.45||An ANCOVA model was used to assess changes from baseline at the average across three frequencies (250-750 Hz) at the Day 49 visit comparing the treatment groups. The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||0.45|-29.24|0.0567
73800597|NCT05258773|147150147|SUPERIORITY||LS Mean difference Arm A - Arm B|-9.0||||0.2588|TWO_SIDED|95.0|-25.0|7.1||An ANCOVA model was used to assess changes from baseline at 500Hz at EOS on Day 105 comparing the treatment groups.The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||7.1|-25.0|0.2588
73893893|NCT01584440|147320713|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.43|||||TWO_SIDED||||||||Day 36|||||
73893894|NCT01584440|147320713|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.75|||||TWO_SIDED||||||||Day 70|||||
73893895|NCT01584440|147320714|SUPERIORITY||OLS Z-statistic|-1.96||||0.05|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.050
73893896|NCT01584440|147320714|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.62|||||TWO_SIDED||||||||Day 36|||||
73893897|NCT01584440|147320714|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.3|||||TWO_SIDED||||||||Day 70|||||
73893898|NCT01584440|147320715|SUPERIORITY||OLS Z-statistic|-2.33||||0.02|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.020
73893899|NCT01584440|147320715|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.57|||||TWO_SIDED||||||||Day 36|||||
73893900|NCT01584440|147320715|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.18|||||TWO_SIDED||||||||Day 70|||||
73893901|NCT01584440|147320716|SUPERIORITY||OLS Z-statistic|1.94||||0.053|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.053
73893902|NCT01584440|147320716|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.52|||||TWO_SIDED||||||||Day 36|||||
73893903|NCT01584440|147320716|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.84|||||TWO_SIDED||||||||Day 70|||||
73893904|NCT01584440|147320717|SUPERIORITY||OLS Z-statistic|-0.72||||0.469|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population|Caregiver|||||0.469
73893905|NCT01584440|147320717|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.28|||||TWO_SIDED||||||||Caregiver: Day 36|||||
73893906|NCT01584440|147320717|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.06|||||TWO_SIDED||||||||Caregiver: Day 70|||||
73893907|NCT01584440|147320717|SUPERIORITY||OLS Z-statistic|1.41||||0.159|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population|Participant|||||0.159
73893908|NCT01584440|147320717|SUPERIORITY||ANCOVA Least Squares Mean Difference|1.09|||||TWO_SIDED||||||||Participant: Day 36|||||
73893909|NCT01584440|147320717|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.7|||||TWO_SIDED||||||||Participant: Day 70|||||
73893910|NCT01584440|147320718|SUPERIORITY||OLS Z-statistic|-1.4||||0.163|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.163
73893911|NCT01584440|147320718|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.07|||||TWO_SIDED||||||||Day 36|||||
73893912|NCT01584440|147320718|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.39|||||TWO_SIDED||||||||Day 70|||||
73893913|NCT01584440|147320719|SUPERIORITY||OLS Z-statistic|-1.08||||0.279|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.279
73893914|NCT01584440|147320719|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.76|||||TWO_SIDED||||||||Day 8|||||
73893915|NCT01584440|147320719|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.02|||||TWO_SIDED||||||||Day 22|||||
73893916|NCT01584440|147320719|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.74|||||TWO_SIDED||||||||Day 43|||||
73893917|NCT01584440|147320719|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.05|||||TWO_SIDED||||||||Day 57|||||
73893918|NCT01584440|147320720|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0001|TWO_SIDED|95.0|1.62|4.5|||ANCOVA||Day 36|||4.50|1.62|0.0001
73893919|NCT01584440|147320720|SUPERIORITY||Odds Ratio (OR)|1.61||||0.2184|TWO_SIDED|95.0|0.75|3.43|||ANCOVA||Day 70|||3.43|0.75|0.2184
73893920|NCT01584440|147320721|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0266|TWO_SIDED|95.0|1.11|5.42|||ANCOVA|||||5.42|1.11|0.0266
73893921|NCT01584440|147320722|SUPERIORITY||Odds Ratio (OR)|2.16||||0.002|TWO_SIDED|95.0|1.31|3.55|||ANCOVA||Day 36|||3.55|1.31|0.002
73893922|NCT01584440|147320722|SUPERIORITY||Odds Ratio (OR)|2.32||||0.031|TWO_SIDED|95.0|1.08|5.0|||ANCOVA||Day 70|||5.00|1.08|0.031
73893923|NCT01584440|147320723|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0048|TWO_SIDED|95.0|1.31|4.46|||ANCOVA|||||4.46|1.31|0.0048
73893924|NCT02872285|147320733|SUPERIORITY||Mean Difference (Final Values)|-12.8||||0.2205|TWO_SIDED|95.0|-33.793|8.199||ANCOVA was used to compare mean percent change in PASI score between baseline and Week 12 between LYC-30937 and placebo treatment groups with treatment as a factor and baseline as a covariate.|ANCOVA|||Subjects included in this analysis had to have both a baseline and Week 12 PASI scores.||8.199|-33.793|0.2205
73893925|NCT02872285|147320734|SUPERIORITY|||||||0.4712|||||||Chi-squared|2-sided p-value.||||||0.4712
73893926|NCT02872285|147320735|SUPERIORITY||Mean Difference (Final Values)|-5.34||||0.6695|TWO_SIDED|95.0|-30.87|20.18|||ANCOVA|||||20.18|-30.87|0.6695
73893927|NCT02872285|147320736|SUPERIORITY|||||||0.4712||||||2-sided p-value|Chi-squared|||||||0.4712
73893928|NCT02872285|147320737|SUPERIORITY|||||||0.4712||||||2-sided p-value|Chi-squared|||||||0.4712
73800598|NCT05258773|147150147|SUPERIORITY||LS Mean difference Arm A - Arm B|-13.84||||0.0979|TWO_SIDED|95.0|-30.49|2.8||An ANCOVA model was used to assess changes from baseline at the average across three frequencies (250-750 Hz) at EOS on Day 105, comparing the treatment groups. The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||2.80|-30.49|0.0979
73800599|NCT05277922|147150149|SUPERIORITY||Geometric mean ratio|0.9999|||||TWO_SIDED|95.0|0.8313|1.2025||||||||1.2025|0.8313|
73893929|NCT01253577|147320743|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||McNemar|||||||0.0280
73893930|NCT01253577|147320744|SUPERIORITY_OR_OTHER||||||<|0.0001|ONE_SIDED|95.0|||||Fisher Exact|||||||<0.0001
73893931|NCT01253577|147320745|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|95.0|||||McNemar|||||||0.0023
73800600|NCT05277922|147150149|SUPERIORITY||Geometric mean ratio|1.2454|||||TWO_SIDED|95.0|1.0355|1.4979||||||||1.4979|1.0355|
73800601|NCT05277922|147150149|SUPERIORITY||Geometric mean ratio|1.2392|||||TWO_SIDED|95.0|1.0304|1.4904||||||||1.4904|1.0304|
73800602|NCT05277922|147150149|SUPERIORITY||Geometric mean ratio|1.2394|||||TWO_SIDED|95.0|1.0305|1.4906||||||||1.4906|1.0305|
73800603|NCT05277922|147150149|SUPERIORITY||Geometric mean ratio|0.995|||||TWO_SIDED|95.0|0.8273|1.1967||||||||1.1967|0.8273|
73800604|NCT05277922|147150149|SUPERIORITY||Geometric mean ratio|1.5058|||||TWO_SIDED|95.0|1.252|1.811||||||||1.8110|1.2520|
73800605|NCT05277922|147150149|SUPERIORITY||Geometric mean ratio|1.506|||||TWO_SIDED|95.0|1.2522|1.8113||||||||1.8113|1.2522|
73800606|NCT05277922|147150149|SUPERIORITY||Geometric mean ratio|1.2091|||||TWO_SIDED|95.0|1.0053|1.4541||||||||1.4541|1.0053|
73893932|NCT05601544|147320940|SUPERIORITY||Least-squares Mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.19|0.25||1-sided p-value was calculated using one-sided type 1 error of 0.025|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-squares mean difference was calculated as Test minus Control|It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.||0.25|0.19|<.0001
73893933|NCT05601544|147320940|SUPERIORITY||Least-squares Mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.14|0.18||1-sided p-value was calculated using one-sided type 1 error of 0.025|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-squares mean difference was calculated as Test minus Control|It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.||0.18|0.14|<.0001
73893934|NCT05601544|147320943|SUPERIORITY||Median Ratio|0.83||||0.0465|TWO_SIDED|98.33|0.64|1.09||1-sided p-value was calculated using one-sided type 1 error of 0.0083.|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Median Ratio was calculated as test over control|It was calculated that 16 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 92% power to detect a statistical superiority with respect to motion detection.||1.09|0.64|0.0465
73893935|NCT05601544|147320944|SUPERIORITY||Least-square Mean Difference|0.14|||<|0.0001|TWO_SIDED|98.33|0.112|0.17||1-sided p-value was calculated using one-sided type 1 error of 0.0083|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|It was calculated that 29 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 91% power to detect a statistical superiority with respect to motion detection.||0.170|0.112|<.0001
73893936|NCT02491632|147320945|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
73893937|NCT02491632|147320945|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
73893938|NCT02491632|147320945|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
73893939|NCT02491632|147320945|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
73893940|NCT02491632|147320946|OTHER||||||=|0.003|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||=.003
73893941|NCT02491632|147320946|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
73893942|NCT02491632|147320946|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
73893943|NCT02491632|147320946|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
73893944|NCT02491632|147320947|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
73800607|NCT05277922|147150149|SUPERIORITY||Geometric mean ratio|1.2151|||||TWO_SIDED|95.0|1.0103|1.4614||||||||1.4614|1.0103|
73800608|NCT05277922|147150149|SUPERIORITY||Geometric mean ratio|1.2456|||||TWO_SIDED|95.0|1.0357|1.4981||||||||1.4981|1.0357|
73800609|NCT03593473|147150169|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at -40 minutes.||||0.37
73800610|NCT03593473|147150169|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at -20 minutes.||||0.40
73800611|NCT03593473|147150169|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 0 minutes.||||0.63
73800612|NCT03593473|147150169|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 10 minutes.||||0.72
73800613|NCT03593473|147150169|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 15 minutes.||||0.88
73800614|NCT03593473|147150169|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 28 minutes.||||0.85
73800615|NCT03593473|147150169|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 38 minutes.||||0.72
73800616|NCT03593473|147150169|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 48 minutes.||||0.57
73800617|NCT03593473|147150169|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol as the outcome variable with time, study arm, and an interaction between time and study arm as the exposure variables. Times are restricted to times 0, +10, +15, and +28, which reflect the measures taken during the Trier Social Stress Test. The p-value presented below is for the interaction term between time and study arm.||||0.96
73800618|NCT03593473|147150170|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at -40 minutes.||||0.71
73800619|NCT03593473|147150170|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at -20 minutes.||||0.92
73800620|NCT03593473|147150170|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 0 minutes.||||0.92
73800621|NCT03593473|147150170|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 10 minutes.||||0.40
73800622|NCT03593473|147150170|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 15 minutes.||||0.97
73800623|NCT03593473|147150170|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 28 minutes.||||0.71
73800624|NCT03593473|147150170|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 38 minutes.||||0.78
73800625|NCT03593473|147150170|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 48 minutes.||||0.63
73800626|NCT03593473|147150170|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol as the outcome variable with time, study arm, and an interaction between time and study arm as the exposure variables. This is the p-value for the interaction term between time and study arm.||||0.11
73800627|NCT03593473|147150171|SUPERIORITY|||||||0.07|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at -40 minutes and Cortisol at -20 minutes.||||0.07
73800628|NCT03593473|147150171|SUPERIORITY|||||||0.22|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at -20 minutes and Cortisol at 0 minutes.||||0.22
73800629|NCT03593473|147150171|SUPERIORITY|||||||0.14|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at 0 minutes and Cortisol at +10 minutes.||||0.14
73800630|NCT03593473|147150171|SUPERIORITY|||||||0.14|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +10 minutes and Cortisol at +15 minutes.||||0.14
73800631|NCT03593473|147150171|SUPERIORITY|||||||0.05|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +15 minutes and Cortisol at +28 minutes.||||0.05
73800632|NCT03593473|147150171|SUPERIORITY|||||||0.1|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +28 minutes and Cortisol at +38 minutes.||||0.10
73800633|NCT03593473|147150171|SUPERIORITY|||||||0.9|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +38 minutes and Cortisol at +48 minutes.||||0.90
73800634|NCT03593473|147150171|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol at time j+1 as the outcome with ACTH at time j, study arm, and an interaction term between ACTH at time j and study arm as the exposure variables. The p-value presented below is for the interaction term between ACTH at time j and study arm.||||0.21
73800635|NCT03593473|147150172|SUPERIORITY|||||||0.8441|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -40 to -35||||0.8441
73800636|NCT03593473|147150172|SUPERIORITY|||||||0.7919|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -35 to -30||||0.7919
73800637|NCT03593473|147150172|SUPERIORITY|||||||0.5639|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -30 to -25||||0.5639
73800638|NCT03593473|147150172|SUPERIORITY|||||||0.3139|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -25 to -20||||0.3139
73800639|NCT03593473|147150172|SUPERIORITY|||||||0.4222|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -20 to -15||||0.4222
73800640|NCT03593473|147150172|SUPERIORITY|||||||0.834|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -15 to -10||||0.834
73800641|NCT03593473|147150172|SUPERIORITY|||||||0.7562|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -10 to -5||||0.7562
73800642|NCT03593473|147150172|SUPERIORITY|||||||0.4245|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -5 to 0||||0.4245
73800643|NCT03593473|147150172|SUPERIORITY|||||||0.1425|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 5 to 8||||0.1425
73800644|NCT03593473|147150172|SUPERIORITY|||||||0.7175|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 8 to 13||||0.7175
73800645|NCT03593473|147150172|SUPERIORITY|||||||0.1417|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 13 to 18||||0.1417
73800646|NCT03593473|147150172|SUPERIORITY|||||||0.0514|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 18 to 23||||0.0514
73800647|NCT03593473|147150172|SUPERIORITY|||||||0.1507|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 23 to 28||||0.1507
73800648|NCT03593473|147150172|SUPERIORITY|||||||0.4204|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 8 to 33||||0.4204
73893945|NCT02491632|147320947|OTHER||||||<|0.065|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.065
73893946|NCT02491632|147320947|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
73893947|NCT02491632|147320947|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
73893948|NCT02491632|147320948|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
73893949|NCT02491632|147320948|OTHER||||||=|0.3|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||=.30
73893950|NCT02491632|147320948|OTHER||||||=|0.19|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||=.19
73893951|NCT02491632|147320948|OTHER||||||=|0.27|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||=.27
73893952|NCT01909011|147320981|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
73893953|NCT01909011|147320982|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||t-test, 2 sided|||||||0.066
73800649|NCT03593473|147150172|SUPERIORITY|||||||0.4209|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 33 to 38||||0.4209
73800650|NCT03593473|147150172|SUPERIORITY|||||||0.2569|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 38 to 43||||0.2569
73893954|NCT01909011|147320983|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||||||0.016
73893955|NCT03818035|147320984|NON_INFERIORITY|One-sided two-group normal approximation Wald Z-test with Mantel-Haenszel stratum weights for 'disease duration' to test for non-inferiority of 100 mg q16w to 100 mg q8w with non-inferiority margin of 10%. Stratified analysis results are reported.|Risk Difference (RD)|-0.6||||0.0013|TWO_SIDED|90.0|-5.7|4.5|||Wald Z-test|||||4.5|-5.7|0.0013
73893956|NCT00982423|147321004|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison between baseline dose of furosemide (3 weeks) versus reduced dose of furosemide (approximately 6 weeks).||||<0.05
73800651|NCT03593473|147150172|SUPERIORITY|||||||0.0828|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 43 to 48||||0.0828
73800652|NCT03593473|147150173|SUPERIORITY|||||||0.6452|||||||t-test, 2 sided|||Pre-ejection period at minutes -40 to -35||||0.6452
73800653|NCT03593473|147150173|SUPERIORITY|||||||0.3228|||||||t-test, 2 sided|||Pre-ejection period at minutes -35 to -30||||0.3228
73893957|NCT00982423|147321004|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Comparison between GFR taken at baseline dose Furosemide (3 weeks) versus normal GFR||||<0.05
73893958|NCT00982423|147321009|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||t-test, 2 sided|||Comparison between reduced dose Furosemide and baseline dose Furosemide||||0.075
73800654|NCT03593473|147150173|SUPERIORITY|||||||0.3541|||||||t-test, 2 sided|||Pre-ejection period at minutes -30 to -25||||0.3541
73800655|NCT03593473|147150173|SUPERIORITY|||||||0.4311|||||||t-test, 2 sided|||Pre-ejection period at minutes -25 to -20||||0.4311
73800656|NCT03593473|147150173|SUPERIORITY|||||||0.3349|||||||t-test, 2 sided|||Pre-ejection period at minutes -20 to -15||||0.3349
73800657|NCT03593473|147150173|SUPERIORITY|||||||0.2646|||||||t-test, 2 sided|||Pre-ejection period at minutes -15 to -10||||0.2646
73800658|NCT03593473|147150173|SUPERIORITY|||||||0.1095|||||||t-test, 2 sided|||Pre-ejection period at minutes -10 to -5||||0.1095
73893959|NCT02712047|147321023|OTHER||Ratio|0.36|||||TWO_SIDED|95.0|0.31|0.43|||||Ratio of FF/VI 100/25mcg versus (Vs) Placebo for Day 1, AM|||0.43|0.31|
73893960|NCT02712047|147321023|OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.28|0.39|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||0.39|0.28|
73893961|NCT02712047|147321023|OTHER||Ratio|0.38|||||TWO_SIDED|95.0|0.32|0.45|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||0.45|0.32|
73893962|NCT02712047|147321023|OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.31|0.44|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||0.44|0.31|
73893963|NCT02712047|147321023|OTHER||Ratio|0.46|||||TWO_SIDED|95.0|0.39|0.54|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||0.54|0.39|
73893964|NCT02712047|147321023|OTHER||Ratio|0.47|||||TWO_SIDED|95.0|0.4|0.56|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||0.56|0.40|
73893965|NCT02712047|147321023|OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.47|0.66|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||0.66|0.47|
73893966|NCT02712047|147321023|OTHER||Ratio|0.58|||||TWO_SIDED|95.0|0.49|0.69|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||0.69|0.49|
73893967|NCT02712047|147321023|OTHER||Ratio|0.63|||||TWO_SIDED|95.0|0.53|0.75|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||0.75|0.53|
73893968|NCT02712047|147321023|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, PM|||0.80|0.57|
73893969|NCT02712047|147321023|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.56|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, AM|||0.80|0.56|
73893970|NCT02712047|147321023|OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, PM|||0.74|0.52|
73893971|NCT02712047|147321023|OTHER||Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.71|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||0.71|0.51|
73893972|NCT02712047|147321023|OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, PM|Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM||0.74|0.52|
73893973|NCT02712047|147321023|OTHER||Ratio|0.69|||||TWO_SIDED|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM|||0.81|0.58|
73893974|NCT02712047|147321023|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, PM|||0.80|0.57|
73893975|NCT02712047|147321023|OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.56|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, AM|||0.78|0.56|
73893976|NCT02712047|147321023|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, PM|||0.80|0.57|
73893977|NCT02712047|147321023|OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.55|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, AM|||0.78|0.55|
73893978|NCT02712047|147321023|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, PM|||0.81|0.58|
73893979|NCT02712047|147321023|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, AM|||0.86|0.61|
73893980|NCT02712047|147321023|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, PM|||0.86|0.61|
73893981|NCT02712047|147321023|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.85|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, AM|||0.85|0.61|
73893982|NCT02712047|147321023|OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.84|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, PM|||0.84|0.60|
73800659|NCT03593473|147150173|SUPERIORITY|||||||0.0194|||||||t-test, 2 sided|||Pre-ejection period at minutes -5 to 0||||0.0194
73800660|NCT03593473|147150173|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||Pre-ejection period at minutes 5 to 8||||0.473
73800661|NCT03593473|147150173|SUPERIORITY|||||||0.5768|||||||t-test, 2 sided|||Pre-ejection period at minutes 8 to 13||||0.5768
73800662|NCT03593473|147150173|SUPERIORITY|||||||0.3477|||||||t-test, 2 sided|||Pre-ejection period at minutes 13 to 18||||0.3477
73800663|NCT03593473|147150173|SUPERIORITY|||||||0.1413|||||||t-test, 2 sided|||Pre-ejection period at minutes 18 to 23||||0.1413
73800664|NCT03593473|147150173|SUPERIORITY|||||||0.2128|||||||t-test, 2 sided|||Pre-ejection period at minutes 23 to 28||||0.2128
73800665|NCT03593473|147150173|SUPERIORITY|||||||0.1415|||||||t-test, 2 sided|||Pre-ejection period at minutes 28 to 33||||0.1415
73800666|NCT03593473|147150173|SUPERIORITY|||||||0.1126|||||||t-test, 2 sided|||Pre-ejection period at minutes 33 to 38||||0.1126
73800667|NCT03593473|147150173|SUPERIORITY|||||||0.1647|||||||t-test, 2 sided|||Pre-ejection period at minutes 38 to 43||||0.1647
73800668|NCT03593473|147150173|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||Pre-ejection period at minutes 43 to 48||||0.088
73893983|NCT02712047|147321023|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, AM|||0.86|0.61|
73800669|NCT01415518|147150185|SUPERIORITY_OR_OTHER||Ratio|1.069|||<|0.0001|TWO_SIDED|95.0|1.043|1.096|||ANCOVA|multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.096|1.043|<.0001
73800670|NCT01415518|147150186|SUPERIORITY_OR_OTHER||Ratio|1.067|||<|0.0001|TWO_SIDED|95.0|1.044|1.09|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.090|1.044|<.0001
73800671|NCT01415518|147150187|SUPERIORITY_OR_OTHER||Ratio|1.068|||<|0.0001||95.0|1.043|1.092|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.092|1.043|<.0001
73800672|NCT01415518|147150188|SUPERIORITY_OR_OTHER||Ratio|1.04||||0.0007|TWO_SIDED|95.0|1.017|1.064|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.064|1.017|0.0007
73800673|NCT01415518|147150189|SUPERIORITY_OR_OTHER||Ratio|1.045|||<|0.0001|TWO_SIDED|95.0|1.024|1.065|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.065|1.024|<.0001
73800674|NCT01415518|147150190|SUPERIORITY_OR_OTHER||Ratio|1.038||||0.0003|TWO_SIDED|95.0|1.017|1.06|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.060|1.017|0.0003
73800675|NCT01415518|147150191|SUPERIORITY_OR_OTHER||Ratio|1.035||||0.0248|TWO_SIDED|95.0|1.004|1.066|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.066|1.004|0.0248
73800676|NCT01415518|147150192|SUPERIORITY_OR_OTHER||Ratio|1.038||||0.0074|TWO_SIDED|95.0|1.01|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.067|1.010|0.0074
73800677|NCT01415518|147150193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.172||||0.0001|TWO_SIDED|95.0|12.733|37.611|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||37.611|12.733|0.0001
73800678|NCT01415518|147150194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.136|||<|0.0001|TWO_SIDED|95.0|12.163|30.11|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||30.110|12.163|<.0001
73800679|NCT01415518|147150195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.044|||<|0.0001|TWO_SIDED|95.0|14.927|31.161|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||31.161|14.927|<.0001
73800680|NCT01415518|147150196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.513|||<|0.0001|TWO_SIDED|95.0|18.74|44.286|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||44.286|18.740|<.0001
73800681|NCT01415518|147150197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.322|||<|0.0001|TWO_SIDED|95.0|14.425|34.22|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||34.220|14.425|<.0001
73800682|NCT01415518|147150198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.168|||<|0.0001|TWO_SIDED|95.0|18.906|35.431|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||35.431|18.906|<.0001
73800683|NCT01415518|147150199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.297||||0.0102|TWO_SIDED|95.0|-0.522|-0.071|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.071|-0.522|0.0102
73800684|NCT01415518|147150200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.343||||0.0004|TWO_SIDED|95.0|-0.533|-0.153|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.153|-0.533|0.0004
73800685|NCT01415518|147150201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.342||||0.0002|TWO_SIDED|95.0|-0.523|-0.162|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.162|-0.523|0.0002
73800686|NCT01415518|147150202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.279|||<|0.0001|TWO_SIDED|95.0|-0.381|-0.177|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.177|-0.381|<.0001
73800687|NCT01415518|147150203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.193||||0.0002|TWO_SIDED|95.0|-0.294|-0.092|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.092|-0.294|0.0002
73800688|NCT01415518|147150204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.208||||0.0001|TWO_SIDED|95.0|-0.308|-0.108|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.108|-0.308|0.0001
73800689|NCT01415518|147150205|SUPERIORITY_OR_OTHER||Rate ratio|0.565||||0.0425|TWO_SIDED|95.0|0.325|0.981|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable||||0.981|0.325|0.0425
73893984|NCT02712047|147321023|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, PM|||0.93|0.66|
73893985|NCT02712047|147321023|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, AM|||0.93|0.66|
73800690|NCT01415518|147150205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.604||||0.088|TWO_SIDED|95.0|0.339|1.078|||Regression, Cox|Time to the first COPD exacerbation||||1.078|0.339|0.0880
73800691|NCT01415518|147150205|SUPERIORITY_OR_OTHER|||||||0.0845|||||||Log Rank|Time to the first COPD exacerbation||||||0.0845
73800692|NCT01415518|147150206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.055||||0.2281|TWO_SIDED|95.0|-0.144|0.035|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||0.035|-0.144|0.2281
73800693|NCT01415518|147150207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.122||||0.001|TWO_SIDED|95.0|-0.194|-0.049|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.049|-0.194|0.0010
73800694|NCT01415518|147150208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.106||||0.0073|TWO_SIDED|95.0|-0.183|-0.029|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.029|-0.183|0.0073
73800695|NCT01730053|147150252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.2|||<|0.0001|TWO_SIDED|98.75|-49.2|-19.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-19.3|-49.2|<0.0001
73800696|NCT01730053|147150252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-36.1|||<|0.0001|TWO_SIDED|98.75|-51.5|-20.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||-20.7|-51.5|<0.0001
73800697|NCT01730053|147150252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.3|||=|0.0453|TWO_SIDED|98.75|-45.8|5.1||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||5.1|-45.8|=0.0453
73800698|NCT01730053|147150252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.3|||=|0.0136|TWO_SIDED|98.75|-50.9|0.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||0.3|-50.9|=0.0136
73800699|NCT01730053|147150253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|98.75|-47.4|-23.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1.25 % level.||-23.0|-47.4|<0.0001
73800700|NCT01730053|147150253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-33.2|||<|0.0001|TWO_SIDED|98.75|-45.9|-20.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-20.5|-45.9|<0.0001
73800701|NCT01730053|147150253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.5|||=|0.0131|TWO_SIDED|98.75|-49.2|0.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||0.2|-49.2|=0.0131
73800702|NCT01730053|147150254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|98.75|-47.4|-17.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-17.9|-47.4|<0.0001
73800703|NCT01730053|147150254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.2|||<|0.0001|TWO_SIDED|98.75|-47.0|-17.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.5|-47|<0.0001
73800704|NCT01730053|147150255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.3|||<|0.0001|TWO_SIDED|98.75|-48.2|-22.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-22.5|-48.2|<0.0001
73800705|NCT01730053|147150255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|98.75|-45.6|-19.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-19.0|-45.6|<0.0001
73800706|NCT01730053|147150256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.2|||<|0.0001|TWO_SIDED|98.75|-40.1|-18.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-18.3|-40.1|<0.0001
73800707|NCT01730053|147150256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-26.8|||<|0.0001|TWO_SIDED|98.75|-37.9|-15.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.7|-37.9|<0.0001
73800708|NCT01730053|147150257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.7|||<|0.0001|TWO_SIDED|98.75|-40.1|-21.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-21.3|-40.1|<0.0001
73800709|NCT01730053|147150257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.3|||<|0.0001|TWO_SIDED|98.75|-38.0|-18.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.7|-38.0|<0.0001
73800710|NCT01730053|147150258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|98.75|-43.9|-18.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-18.9|-43.9|<0.0001
73800711|NCT01730053|147150258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|98.75|-42.1|-16.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.4|-42.1|<0.0001
73800712|NCT01730053|147150259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.8|||<|0.0001|TWO_SIDED|98.75|-43.2|-22.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-22.4|-43.2|<0.0001
73800713|NCT01730053|147150259|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|98.75|-39.1|-17.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.3|-39.1|<0.0001
73893986|NCT02712047|147321023|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.56|0.79|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, PM|||0.79|0.56|
73893987|NCT02712047|147321023|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, AM|||0.93|0.66|
73893988|NCT02712047|147321023|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, PM|||0.94|0.66|
73893989|NCT02712047|147321023|OTHER||Ratio|0.74|||||TWO_SIDED|95.0|0.62|0.87|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, AM|||0.87|0.62|
73893990|NCT02712047|147321023|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, PM|||0.86|0.61|
73893991|NCT02712047|147321023|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.65|0.91|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, AM|||0.91|0.65|
73893992|NCT02712047|147321023|OTHER||Ratio|0.81|||||TWO_SIDED|95.0|0.65|1.01|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, PM|||1.01|0.65|
73893993|NCT02712047|147321023|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, AM|||0.96|0.61|
73893994|NCT02712047|147321023|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.59|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, PM|||1.00|0.59|
73893995|NCT02712047|147321023|OTHER||Ratio|0.81|||||TWO_SIDED|95.0|0.63|1.05|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, AM|||1.05|0.63|
73893996|NCT02712047|147321023|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.52|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, PM|||1.00|0.52|
73893997|NCT02712047|147321023|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.56|1.09|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, AM|||1.09|0.56|
73893998|NCT02712047|147321023|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.53|1.14|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, PM|||1.14|0.53|
73893999|NCT02712047|147321023|OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.59|1.22|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||1.22|0.59|
73894000|NCT02712047|147321023|OTHER||Ratio|0.75|||||TWO_SIDED|95.0|0.5|1.13|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, PM|||1.13|0.50|
73894001|NCT02712047|147321023|OTHER||Ratio|0.83|||||TWO_SIDED|95.0|0.55|1.25|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, AM|||1.25|0.55|
73894002|NCT02712047|147321023|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.51|1.16|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, PM|||1.16|0.51|
73894003|NCT02712047|147321023|OTHER||Ratio|0.99|||||TWO_SIDED|95.0|0.66|1.49|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, AM|||1.49|0.66|
73894004|NCT02712047|147321023|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.29|1.51|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, PM|||1.51|0.29|
73894005|NCT02712047|147321023|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.32|1.64|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 24, AM|||1.64|0.32|
73894006|NCT02712047|147321025|OTHER||Mean Difference (Net)|45.86|||||TWO_SIDED|95.0|23.69|68.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM|||68.03|23.69|
73894007|NCT02712047|147321025|OTHER||Mean Difference (Net)|45.37|||||TWO_SIDED|95.0|23.2|67.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||67.55|23.20|
73894008|NCT02712047|147321025|OTHER||Mean Difference (Net)|34.03|||||TWO_SIDED|95.0|11.86|56.21|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||56.21|11.86|
73894009|NCT02712047|147321025|OTHER||Mean Difference (Net)|31.56|||||TWO_SIDED|95.0|9.38|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||53.73|9.38|
73894010|NCT02712047|147321025|OTHER||Mean Difference (Net)|22.86|||||TWO_SIDED|95.0|0.68|45.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||45.03|0.68|
73894011|NCT02712047|147321025|OTHER||Mean Difference (Net)|36.94|||||TWO_SIDED|95.0|14.77|59.12|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||59.12|14.77|
73894012|NCT02712047|147321025|OTHER||Mean Difference (Net)|19.33|||||TWO_SIDED|95.0|-3.0|41.66|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||41.66|-3.00|
73894013|NCT02712047|147321025|OTHER||Mean Difference (Net)|20.85|||||TWO_SIDED|95.0|-1.32|43.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||43.03|-1.32|
73894014|NCT02712047|147321025|OTHER||Mean Difference (Net)|16.82|||||TWO_SIDED|95.0|-5.47|39.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||39.11|-5.47|
73894015|NCT02712047|147321025|OTHER||Mean Difference (Net)|21.86|||||TWO_SIDED|95.0|-0.41|44.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, PM|||44.14|-0.41|
73894016|NCT02712047|147321025|OTHER||Mean Difference (Net)|13.05|||||TWO_SIDED|95.0|-9.57|35.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, AM|||35.67|-9.57|
73894017|NCT02712047|147321025|OTHER||Mean Difference (Net)|28.68|||||TWO_SIDED|95.0|5.38|51.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, PM|||51.98|5.38|
73894018|NCT02712047|147321025|OTHER||Mean Difference (Net)|17.09|||||TWO_SIDED|95.0|-5.08|39.26|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||39.26|-5.08|
73894019|NCT02712047|147321025|OTHER||Mean Difference (Net)|23.61|||||TWO_SIDED|95.0|0.28|46.94|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, PM|||46.94|0.28|
73894020|NCT02712047|147321025|OTHER||Mean Difference (Net)|12.87|||||TWO_SIDED|95.0|-9.3|35.05|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, AM|||35.05|-9.30|
73894021|NCT02712047|147321025|OTHER||Mean Difference (Net)|7.5|||||TWO_SIDED|95.0|-14.67|29.68|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, PM|||29.68|-14.67|
73894022|NCT02712047|147321025|OTHER||Mean Difference (Net)|3.32|||||TWO_SIDED|95.0|-19.11|25.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, AM|||25.74|-19.11|
73894023|NCT02712047|147321025|OTHER||Mean Difference (Net)|3.83|||||TWO_SIDED|95.0|-18.34|26.0|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, PM|||26.00|-18.34|
73894024|NCT02712047|147321025|OTHER||Mean Difference (Net)|11.36|||||TWO_SIDED|95.0|-11.11|33.82|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, AM|||33.82|-11.11|
73894025|NCT02712047|147321025|OTHER||Mean Difference (Net)|27.73|||||TWO_SIDED|95.0|5.43|50.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, PM|||50.03|5.43|
73894026|NCT02712047|147321025|OTHER||Mean Difference (Net)|14.71|||||TWO_SIDED|95.0|-7.57|36.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, AM|||36.98|-7.57|
73894027|NCT02712047|147321025|OTHER||Mean Difference (Net)|-6.62|||||TWO_SIDED|95.0|-28.8|15.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, PM|||15.55|-28.80|
73894028|NCT02712047|147321025|OTHER||Mean Difference (Net)|4.36|||||TWO_SIDED|95.0|-18.39|27.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, AM|||27.11|-18.39|
73894029|NCT02712047|147321025|OTHER||Mean Difference (Net)|8.29|||||TWO_SIDED|95.0|-13.99|30.57|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, PM|||30.57|-13.99|
73894030|NCT02712047|147321025|OTHER||Mean Difference (Net)|0.64|||||TWO_SIDED|95.0|-21.64|22.92|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, AM|||22.92|-21.64|
73894031|NCT02712047|147321025|OTHER||Mean Difference (Net)|-6.88|||||TWO_SIDED|95.0|-29.96|16.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, PM|||16.19|-29.96|
73800714|NCT01730053|147150260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.6|||<|0.0001|TWO_SIDED|98.75|-29.4|-11.8||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-11.8|-29.4|<0.0001
73800715|NCT01730053|147150260|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.3|||<|0.0001|TWO_SIDED|98.75|-29.3|-11.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.2|-29.3|<0.0001
73800716|NCT01730053|147150261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.1|||<|0.0001|TWO_SIDED|98.75|-39.7|-16.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-16.5|-39.7|<0.0001
73800717|NCT01730053|147150261|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.0|||<|0.0001|TWO_SIDED|98.75|-35.7|-12.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.3|-35.7|<0.0001
73800718|NCT01730053|147150262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.5|||<|0.0001|TWO_SIDED|98.75|-42.1|-16.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-16.9|-42.1|<0.0001
73800719|NCT01730053|147150262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.9|||<|0.0001|TWO_SIDED|98.75|-37.7|-12.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.2|-37.7|<0.0001
73800720|NCT01730053|147150263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.1|||<|0.0001|TWO_SIDED|98.75|-29.4|-10.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-10.7|-29.4|<0.0001
73800721|NCT01730053|147150263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.2|||<|0.0001|TWO_SIDED|98.75|-26.7|-7.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.7|-26.7|<0.0001
73800722|NCT01730053|147150264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.4|||<|0.0001|TWO_SIDED|98.75|2.6|59.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||59.5|2.6|<0.0001
73800723|NCT01730053|147150264|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.4|||=|0.0007|TWO_SIDED|98.75|1.8|40.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||40.5|1.8|=0.0007
73800724|NCT01730053|147150265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.6|||<|0.0001|TWO_SIDED|98.75|2.58|88.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||88.2|2.58|<0.0001
73800725|NCT01730053|147150265|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.9|||=|0.001|TWO_SIDED|98.75|1.7|56.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||56.7|1.7|=0.001
73800726|NCT01730053|147150266|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.6|||<|0.0001|TWO_SIDED|98.75|3.6|96.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||96.2|3.6|<0.0001
73800727|NCT01730053|147150266|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.6|||<|0.0001|TWO_SIDED|98.75|2.5|53.1||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||53.1|2.5|<0.0001
73800728|NCT01730053|147150267|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|20.3|||<|0.0001|TWO_SIDED|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||67.7|2.4|<0.0001
73800729|NCT01730053|147150267|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.7|||=|0.0002|TWO_SIDED|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||67.7|2.4|=0.0002
73800730|NCT01730053|147150268|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-23.9|||<|0.0001|TWO_SIDED|98.75|-38.6|-9.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-9.1|-38.6|<0.0001
73800731|NCT01730053|147150268|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-23.6|||=|0.0001|TWO_SIDED|98.75|-39.0|-8.2||Threshold for significance ≤ 0.0125.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.2|-39.0|=0.0001
73800732|NCT01730053|147150269|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|7.4|||=|0.0311|TWO_SIDED|98.75|-1.2|16.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||16.1|-1.2|=0.0311
73800733|NCT02019472|147150290|SUPERIORITY_OR_OTHER||LS mean difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.07|-0.46|||ANCOVA|||||-0.46|-1.07|< 0.001
73800734|NCT02019472|147150290|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.39|||=|0.013|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||||-0.08|-0.69|=0.013
73800735|NCT02019472|147150291|SUPERIORITY_OR_OTHER||Percentage Difference|-4.8||||0.306|TWO_SIDED|95.0|-14.1|4.4|||Cochran-Mantel-Haenszel|||||4.4|-14.1|0.306
73800736|NCT02019472|147150291|SUPERIORITY_OR_OTHER||Percentage Difference|3.6||||0.464|TWO_SIDED|95.0|-6.0|13.1|||Cochran-Mantel-Haenszel|||||13.1|-6|0.464
73894032|NCT02712047|147321025|OTHER||Mean Difference (Net)|28.45|||||TWO_SIDED|95.0|5.76|51.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, AM|||51.13|5.76|
73894033|NCT02712047|147321025|OTHER||Mean Difference (Net)|12.31|||||TWO_SIDED|95.0|-10.13|34.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, PM|||34.74|-10.13|
73894034|NCT02712047|147321025|OTHER||Mean Difference (Net)|4.1|||||TWO_SIDED|95.0|-18.16|26.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, AM|||26.36|-18.16|
73894035|NCT02712047|147321025|OTHER||Mean Difference (Net)|18.87|||||TWO_SIDED|95.0|-3.89|41.63|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, PM|||41.63|-3.89|
73894036|NCT02712047|147321025|OTHER||Mean Difference (Net)|6.35|||||TWO_SIDED|95.0|-16.17|28.88|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, AM|||28.88|-16.17|
73894037|NCT02712047|147321025|OTHER||Mean Difference (Net)|19.07|||||TWO_SIDED|95.0|-3.27|41.41|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, PM|||41.41|-3.27|
73894038|NCT02712047|147321025|OTHER||Mean Difference (Net)|29.51|||||TWO_SIDED|95.0|6.87|52.15|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, AM|||52.15|6.87|
73894039|NCT02712047|147321025|OTHER||Mean Difference (Net)|9.64|||||TWO_SIDED|95.0|-17.91|37.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, PM|||37.19|-17.91|
73894040|NCT02712047|147321025|OTHER||Mean Difference (Net)|24.77|||||TWO_SIDED|95.0|-4.2|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, AM|||53.73|-4.20|
73894041|NCT02712047|147321025|OTHER||Mean Difference (Net)|47.04|||||TWO_SIDED|95.0|14.63|79.45|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, PM|||79.45|14.63|
73894042|NCT02712047|147321025|OTHER||Mean Difference (Net)|20.11|||||TWO_SIDED|95.0|-12.3|52.52|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, AM|||52.52|-12.30|
73894043|NCT02712047|147321025|OTHER||Mean Difference (Net)|25.13|||||TWO_SIDED|95.0|-15.02|65.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, PM|||65.27|-15.02|
73894044|NCT02712047|147321025|OTHER||Mean Difference (Net)|-7.89|||||TWO_SIDED|95.0|-48.04|32.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, AM|||32.25|-48.04|
73894045|NCT02712047|147321025|OTHER||Mean Difference (Net)|8.51|||||TWO_SIDED|95.0|-37.22|54.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, PM|||54.25|-37.22|
73894046|NCT02712047|147321025|OTHER||Mean Difference (Net)|15.08|||||TWO_SIDED|95.0|-28.5|58.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||58.67|-28.50|
73894047|NCT02712047|147321025|OTHER||Mean Difference (Net)|5.19|||||TWO_SIDED|95.0|-45.35|55.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, PM|||55.73|-45.35|
73894048|NCT02712047|147321026|OTHER||Mean Difference (Net)|0.36|||||TWO_SIDED|95.0|0.26|0.46|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM|||0.46|0.26|
73800737|NCT02019472|147150292|SUPERIORITY_OR_OTHER||Percentage Difference|5.4||||0.086|TWO_SIDED|95.0|-0.7|11.4|||Cochran-Mantel-Haenszel|||||11.4|-0.7|0.086
73894049|NCT02712047|147321026|OTHER||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||0.36|0.16|
73894050|NCT02712047|147321026|OTHER||Mean Difference (Net)|0.34|||||TWO_SIDED|95.0|0.24|0.44|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||0.44|0.24|
73894051|NCT02712047|147321026|OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||0.34|0.14|
73894052|NCT02712047|147321026|OTHER||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||0.36|0.16|
73894053|NCT02712047|147321026|OTHER||Mean Difference (Net)|0.18|||||TWO_SIDED|95.0|0.08|0.28|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||0.28|0.08|
73894054|NCT02712047|147321026|OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||0.34|0.14|
73894055|NCT02712047|147321026|OTHER||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|0.07|0.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||0.27|0.07|
73894056|NCT02712047|147321026|OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.03|0.17|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||0.17|-0.03|
73894057|NCT02712047|147321026|OTHER||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.06|0.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||0.14|-0.06|
73894058|NCT02712047|147321026|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.07|0.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||0.13|-0.07|
73894059|NCT00147069|147321041|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
73894060|NCT00147069|147321042|SUPERIORITY|||||||0.05||||||The reported p value was calculated|Kruskal-Wallis|||||||0.05
73894061|NCT00147069|147321043|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
73894062|NCT00147069|147321044|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
73894063|NCT00122980|147321045|NON_INFERIORITY_OR_EQUIVALENCE|"Based on pilot data, the efficacy of hydroxyurea to reduce secondary stroke rate was not predicted to be equivalent to transfusions. Therefore, an increased stroke rate (non-inferiority margin = 0.20) was allowed by study design. This acceptable stroke margin was predicted to be offset by the likelihood of significantly greater improvement in the management of iron overload through elimination of transfusions along with serial phlebotomy in the Hydroxyurea/Phlebotomy arm."||||||0.214||95.0|||||Log Rank|||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20, the non-inferiority margin, AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean LIC is less than for Transfusion/Chelation (see next primary endpoint analysis).||||0.214
73894064|NCT00122980|147321046|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||The a priori defined LOCF approach was deemed to be biased due to the study's early termination, and was replaced by this mixed models analysis.|Mixed Models Analysis|Including main effects of age at consent, baseline iron, and treatment group, on observed change from baseline Log10 transformed values only.||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis (see previous primary endpoint analysis) in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20 AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean log10 transformed LIC is less than for Transfusion/Chelation.||||0.144
73800738|NCT02019472|147150292|SUPERIORITY_OR_OTHER||Percentage Difference|12.8|||<|0.001|TWO_SIDED|95.0|5.9|19.7|||Cochran-Mantel-Haenszel|||||19.7|5.9|< 0.001
73800739|NCT02019472|147150293|SUPERIORITY_OR_OTHER||Percentage Difference|-2.7||||0.603|TWO_SIDED|95.0|-12.8|7.4|||Cochran-Mantel-Haenszel|||||7.4|-12.8|0.603
73800740|NCT02019472|147150293|SUPERIORITY_OR_OTHER||Percentage Difference|2.4||||0.644|TWO_SIDED|95.0|-7.6|12.3|||Cochran-Mantel-Haenszel|||||12.3|-7.6|0.644
73800741|NCT02806908|147150294|SUPERIORITY|||||||0.0022|||||||ANOVA|||||||0.0022
73800742|NCT02806908|147150295|SUPERIORITY|||||||0.0416|||||||ANOVA|||||||0.0416
73800743|NCT02806908|147150296|SUPERIORITY|||||||0.0963|||||||McNemar|||||||0.0963
73800744|NCT02806908|147150297|SUPERIORITY|||||||0.3018|||||||McNemar|||||||0.3018
73800745|NCT02806908|147150298|SUPERIORITY|||||||0.424|||||||McNemar|||||||0.4240
73800746|NCT02806908|147150299|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
73800747|NCT02806908|147150300|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
73800748|NCT02806908|147150301|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
73894065|NCT00122980|147321047|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||>0.05
73800749|NCT02806908|147150302|SUPERIORITY|||||||0.6291|||||||McNemar|||||||0.6291
73800750|NCT02806908|147150303|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
73800751|NCT02806908|147150304|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
73894066|NCT00122980|147321048|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||||>0.05
73800752|NCT02806908|147150305|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
73800753|NCT02806908|147150306|SUPERIORITY|||||||0.7744|||||||McNemar|||||||0.7744
73800754|NCT02806908|147150307|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
73800755|NCT02806908|147150308|SUPERIORITY|||||||0.1141|||||||ANOVA|||||||0.1141
73800756|NCT02806908|147150309|SUPERIORITY|||||||0.4441|||||||ANOVA|||||||0.4441
73800757|NCT02806908|147150310|SUPERIORITY|||||||0.3423|||||||ANOVA|||||||0.3423
73800758|NCT02806908|147150311|SUPERIORITY|||||||0.9384|||||||ANOVA|||||||0.9384
73800759|NCT02806908|147150312|SUPERIORITY|||||||0.0939|||||||ANOVA|||||||0.0939
73800760|NCT02806908|147150313|SUPERIORITY|||||||0.0246|||||||ANOVA|||||||0.0246
73800761|NCT02806908|147150314|SUPERIORITY|||||||0.1475|||||||ANOVA|||||||0.1475
73800762|NCT02806908|147150315|SUPERIORITY|||||||0.1513|||||||ANOVA|||||||0.1513
73800763|NCT02806908|147150316|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
73800764|NCT02806908|147150317|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
73800765|NCT02806908|147150318|SUPERIORITY|||||||0.4774|||||||ANOVA|||||||0.4774
73800766|NCT02806908|147150319|SUPERIORITY|||||||0.3801|||||||ANOVA|||||||0.3801
73800767|NCT02806908|147150320|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73800768|NCT01760304|147150321|SUPERIORITY|||||||0.769|||||||2-sided paired t-test|||a paired t-test was calculated comparing baseline measures and post intervention||||0.769
73800769|NCT01760304|147150321|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired T-test|||a paired t-test was calculated comparing baseline measures and post intervention||||<0.0001
73800770|NCT01760304|147150323|SUPERIORITY_OR_OTHER||||||<|0.05|||||||paired t-test|||||||<0.05
73800771|NCT04429503|147150324|NON_INFERIORITY|p-value for one-sided non-inferiority (NI) test at a margin of 4 letters|Least Square (LS) Mean Difference|-0.57|||<|0.0001|TWO_SIDED|95.0|-2.26|1.13|||Mixed Model for Repeated Measurements||HDq12 minus 2q8|||1.13|-2.26|<0.0001
73800772|NCT04429503|147150324|NON_INFERIORITY|p-value for one-sided non-inferiority (NI) test at a margin of 4 letters|LS Mean Difference|-1.44||||0.0031|TWO_SIDED|95.0|-3.27|0.39|||Mixed Model for Repeated Measurements||HDq16 minus 2q8|||0.39|-3.27|0.0031
73800773|NCT04429503|147150325|NON_INFERIORITY|The non-inferiority margin was set at 15%|Adjusted Difference (%)|1.98|||||TWO_SIDED|95.0|-6.61|10.57|||||Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors|||10.57|-6.61|
73800774|NCT04429503|147150325|NON_INFERIORITY|The non-inferiority margin was set at 15%.|Adjusted Difference (%)|-7.52|||||TWO_SIDED|95.0|-16.88|1.84|||||Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors|||1.84|-16.88|
73800775|NCT05516108|147150346|OTHER|||||||0.004|||||||Mixed Models Analysis|Stata mixed||time (pre, post, follow-up) x condition (mindfulness, coping)||||.004
73800776|NCT05516108|147150347|OTHER|||||||0.02|||||||Mixed Models Analysis|||time (pre, post, follow-up) x condition (mindfulness, coping)||||.020
73800777|NCT05516108|147150348|OTHER|||||||0.74|||||||Mixed Models Analysis|Stata melogit||time (pre, post, follow-up) x condition (mindfulness, coping)||||.74
73800778|NCT05516108|147150349|OTHER|||||||0.1|||||||Mixed Models Analysis|||time (pre, post, follow-up) x condition (mindfulness, coping)||||.10
73800779|NCT05516108|147150350|OTHER|||||||0.009|||||||Mixed Models Analysis|Stata mixed||time (pre, post, follow-up) x condition (mindfulness, coping)||||.009
73800780|NCT03500198|147150432|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
73800781|NCT03500198|147150434|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
73800782|NCT03500198|147150435|SUPERIORITY||||||<|0.0001|||||||1-sided logistic regression|||||||<0.0001
73800783|NCT01836471|147150458|SUPERIORITY_OR_OTHER||least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.038||0.7269|TWO_SIDED|90.0|-0.5|0.08|||Mixed Models Analysis|||||0.08|-0.5|0.7269
73800784|NCT01836471|147150459|SUPERIORITY_OR_OTHER||least sqares mean|0.01|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|90.0|-0.08|0.09||||||||0.09|-0.08|
73800785|NCT01836471|147150459|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|90.0|-0.04|0.13||||||||0.13|-0.04|
73800786|NCT01836471|147150459|SUPERIORITY_OR_OTHER||least squares mean|-0.04|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|90.0|-0.13|0.05||||||||0.05|-0.13|
73800787|NCT01836471|147150460|SUPERIORITY_OR_OTHER|||||||0.9179|||||||Mixed Models Analysis|||||||0.9179
73894067|NCT00122980|147321049|SUPERIORITY_OR_OTHER|||||||0.841||95.0|||||ANOVA|||The change-from-baseline to endpoint scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||||0.841
73894068|NCT00122980|147321050|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||>0.05
73894069|NCT00122980|147321051|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||0.039
73894070|NCT00122980|147321052|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANCOVA|Analysis controlling for baseline value and time on study.||||||0.033
73894071|NCT00122980|147321053|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Controlling for baseline value and time on study||||||<0.01
73894072|NCT01243242|147321060|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using the median test for independent samples|Median|||For the primary endpoint (CAARS change), median test was applied as the primary analysis due to outlier numbers observed ; secondary analysis of the primary endpoint utilized ANCOVA with adjustment to age, gender and site (which is usually expected to influence the endpoint) as well as baseline values. Additional parametric T-test was applied, but was found less effective due to outlier values.||||0.0093
73894073|NCT01243242|147321061|SUPERIORITY_OR_OTHER|||||||0.0195||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age|ANCOVA|||Analysis of Covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) and to Visits 3 through 5 in the primary endpoint, CAARS, and secondary endpoint scales, CGI-S, TOVA and AAQoL between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).||||0.0195
73894074|NCT01243242|147321062|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age.|ANCOVA|||Analysis of covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).||||0.0093
73894075|NCT01256294|147321094|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.02|||||TWO_SIDED|95.0|0.96|1.09||||||||1.09|0.96|
73894076|NCT01256294|147321094|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.02||||0.486|TWO_SIDED|90.0|0.97|1.08||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of AUC0-12h were assessed relative to the interval \[80%, 125%\].||1.08|0.97|0.486
73800788|NCT01836471|147150461|SUPERIORITY_OR_OTHER||least squares mean|-0.02|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|95.0|-0.22|0.17||||||||0.17|-0.22|
73800789|NCT01836471|147150461|SUPERIORITY_OR_OTHER||least sqares mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|-0.32|0.19||||||||0.19|-0.32|
73800790|NCT01836471|147150461|SUPERIORITY_OR_OTHER||least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.16|0.37||||||||0.37|-0.16|
73894077|NCT01256294|147321099|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.09|||||TWO_SIDED|95.0|1.0|1.2|||||Ratio of geometric means: Generic tacrolimus/Branded tacrolimus|||1.20|1.00|
73894078|NCT01256294|147321099|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.09||||0.057|TWO_SIDED|90.0|1.01|1.18||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of Cmax were assessed relative to the interval \[80%, 125%\].||1.18|1.01|0.057
73894079|NCT02160899|147321100|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
73800791|NCT01836471|147150461|SUPERIORITY_OR_OTHER||least squares mean|-0.17|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.43|0.09||||||||0.09|-0.43|
73800792|NCT01836471|147150462|SUPERIORITY_OR_OTHER|||||||0.793|||||||Mixed Models Analysis|||||||0.7930
73800793|NCT01422213|147150581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|0.22|0.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the mixed model for repeated measurements (MMRM) with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.||0.50|0.22|<0.0001
73800794|NCT01422213|147150581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|0.19|0.47||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.||0.47|0.19|<0.0001
73894080|NCT02160899|147321100|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
73894081|NCT02160899|147321100|SUPERIORITY|||||||0.044|||||||Exact Wilcoxon Rank Sum Test|||||||0.044
73894082|NCT00669409|147321129|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-17.8|13.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.8|-17.8|
73894083|NCT00669409|147321129|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-34.3|-2.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.8|-34.3|
73894084|NCT00669409|147321129|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-18.5|13.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.1|-18.5|
73800795|NCT01422213|147150582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|2.5|5.9||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||5.90|2.50|<0.0001
73800796|NCT01422213|147150582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|2.57|5.94||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||5.94|2.57|<0.0001
73800797|NCT01422213|147150583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|0.46||0.0287|TWO_SIDED|95.0|0.11|1.93||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.93|0.11|0.0287
73800798|NCT01422213|147150583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.46||0.1988|TWO_SIDED|95.0|-0.31|1.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.50|-0.31|0.1988
73800799|NCT01422213|147150584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.24||0.0033|TWO_SIDED|95.0|0.24|1.19||Since the p-value for RAVLT acquisition for 10 mg was \>0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.19|0.24|0.0033
73800800|NCT01422213|147150584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.24||0.0073|TWO_SIDED|95.0|0.17|1.12||Since the p-value for RAVLT acquisition for 20 mg was \>0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.12|0.17|0.0073
73800801|NCT01422213|147150585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|1.37||0.0061|TWO_SIDED|95.0|-6.45|-1.08||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.08|-6.45|0.0061
73800802|NCT01422213|147150585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|1.35||0.0052|TWO_SIDED|95.0|-6.46|-1.14||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.14|-6.46|0.0052
73800803|NCT01422213|147150586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.57|STANDARD_ERROR_OF_MEAN|2.73||0.0058|TWO_SIDED|95.0|-12.93|-2.2||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.20|-12.93|0.0058
73800804|NCT01422213|147150586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.01|STANDARD_ERROR_OF_MEAN|2.7||0.0009|TWO_SIDED|95.0|-14.32|-3.7||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-3.70|-14.32|0.0009
73800805|NCT01422213|147150587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|1.28||0.0018|TWO_SIDED|95.0|-6.5|-1.49||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.49|-6.50|0.0018
73800806|NCT01422213|147150587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.45|STANDARD_ERROR_OF_MEAN|1.26||0.0005|TWO_SIDED|95.0|-6.93|-1.97||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.97|-6.93|0.0005
73800807|NCT01422213|147150588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|2.04||0.001|TWO_SIDED|95.0|-10.76|-2.74||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.74|-10.76|0.0010
73894085|NCT00669409|147321129|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-29.4|1.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.8|-29.4|
73800808|NCT01422213|147150588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.52|STANDARD_ERROR_OF_MEAN|2.02||0.0013|TWO_SIDED|95.0|-10.49|-2.54||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.54|-10.49|0.0013
73800809|NCT01422213|147150589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|-0.07|-0.02||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.02|-0.07|0.0002
73800810|NCT01422213|147150589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0157|TWO_SIDED|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.01|-0.05|0.0157
73800811|NCT01422213|147150590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.009||0.0005|TWO_SIDED|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.01|-0.05|0.0005
73800812|NCT01422213|147150590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.009||0.3549|TWO_SIDED|95.0|-0.03|0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||0.01|-0.03|0.3549
73800813|NCT01422213|147150591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-6.45|-2.96||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.96|-6.45|<0.0001
73800814|NCT01422213|147150591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-8.43|-4.98||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-4.98|-8.43|<0.0001
73800815|NCT01422213|147150592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.88|-0.42||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.42|-0.88|<0.0001
73800816|NCT01422213|147150592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.08|-0.62||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.62|-1.08|<0.0001
73800817|NCT01422213|147150593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.81|-0.4||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.||-0.40|-0.81|<0.0001
73800818|NCT01422213|147150593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.06|-0.65||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.||-0.65|-1.06|<0.0001
73800819|NCT01422213|147150594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0002|TWO_SIDED|95.0|1.44|3.33||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||3.33|1.44|0.0002
73800820|NCT01422213|147150594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.43|||<|0.0001|TWO_SIDED|95.0|2.26|5.21||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||5.21|2.26|<0.0001
73800821|NCT01422213|147150595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.003|TWO_SIDED|95.0|1.29|3.41||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||3.41|1.29|0.0030
73800822|NCT01422213|147150595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.0001|TWO_SIDED|95.0|1.95|5.03||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||5.03|1.95|<0.0001
73800823|NCT01422213|147150596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.059||0.0393|TWO_SIDED|95.0|0.01|0.24||No adjustment for multiplicity was made.|ANCOVA|||||0.24|0.01|0.0393
73800824|NCT01422213|147150597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.068||0.0007|TWO_SIDED|95.0|0.1|0.36||No adjustment for multiplicity was made.|ANCOVA|||||0.36|0.10|0.0007
73800825|NCT01422213|147150597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.068||0.0246|TWO_SIDED|95.0|0.02|0.29||No adjustment for multiplicity was made.|ANCOVA|||||0.29|0.02|0.0246
73894086|NCT00669409|147321129|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-34.5|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-55.2|-13.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-13.7|-55.2|
73894087|NCT00669409|147321130|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-19.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-19.4|
73800826|NCT01891864|147150654|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin for the comparison of GP2015 with Enbrel with respect to PASI 75 response at Week 12 was based on response rates reported in two pivotal placebo controlled trials (Leonardi et al 2003; Papp et al 2005). Based on the observed effect size of 45-46%, an equivalence margin of 18% was chosen so that at least 60% of the treatment effect seen for Enbrel was maintained. A response rate of 49% was assumed for the comparator treatment Enbrel.|Risk Difference (RD)|-2.3|||||TWO_SIDED|95.0|-9.85|5.3||||||PASI 75 response rate (proportion of patients showing at least a 75% improvement in PASI) after the first 12 weeks of treatment (Treatment Period 1) was the primary endpoint to assess equivalence between GP2015 and Enbrel®. Therapeutic equivalence in terms of PASI75 could be concluded if the exact 95% confidence interval for the difference in the PASI75 rates is completely contained within the interval \[-18%; 18%\]. A logistic regression model was to be employed.||5.3|-9.85|
73800827|NCT01891864|147150655|NON_INFERIORITY_OR_EQUIVALENCE|A MMRM (Mixed Model Repeated Method) was performed on the percentage change from baseline in PASI score from baseline to Week 12. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval \[-15%; 15%\].|Mean Difference (Final Values)|-0.64|||||TWO_SIDED|95.0|-3.474|2.204||||||||2.204|-3.474|
73800828|NCT01891864|147150655|NON_INFERIORITY_OR_EQUIVALENCE|The mean averaged treatment effect (ATE) of percent change from baseline in PASI score up to week 12 was derived for each patient and analyzed using an ANCOVA approach. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval \[-15%; 15%\].|Mean Difference (Final Values)|-0.88|||||TWO_SIDED|95.0|-3.61|1.845||||||||1.845|-3.61|
73800829|NCT02892331|147150664|SUPERIORITY|||||||0.006||||||VO2 testing was not performed for one participant in the HIGH-INT group.|ANCOVA|||Comparison between the CON and the HIGH-INT group||||0.006
73800830|NCT02892331|147150664|SUPERIORITY|||||||0.045||||||VO2 testing was not performed for one participant in the HIGH-INT group.|ANCOVA|||Comparison between the CON and MOD-INT group||||0.045
73800831|NCT02892331|147150664|SUPERIORITY|VO2 testing was not performed for one participant in the HIGH-INT group.||||||0.449|||||||ANCOVA|||Comparison between MOD-INT and High-INT groups||||0.449
73800832|NCT02892331|147150665|SUPERIORITY|||||||0.276|||||||ANCOVA|||Comparison between the CON and High-INT groups||||0.276
73800833|NCT02892331|147150665|SUPERIORITY|||||||0.633|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.633
73800834|NCT02892331|147150665|SUPERIORITY|||||||0.555|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.555
73800835|NCT02892331|147150666|SUPERIORITY|||||||0.37|||||||ANCOVA|||Comparison between the CON group and the HIGH-INT group||||0.370
73800836|NCT02892331|147150666|SUPERIORITY|||||||0.383|||||||ANCOVA|||Comparison between the CON and the MOD-INT group||||0.383
73894088|NCT00669409|147321130|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.8|0.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.8|-30.8|
73800837|NCT02892331|147150666|SUPERIORITY|||||||0.0972|||||||ANCOVA|||Comparison for the MOD-INT and HIGH-INT groups||||0.0972
73800838|NCT02892331|147150667|SUPERIORITY|||||||0.932|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.932
73800839|NCT02892331|147150667|SUPERIORITY|||||||0.307|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.307
73800840|NCT02892331|147150667|SUPERIORITY|||||||0.376|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.376
73800841|NCT02892331|147150668|SUPERIORITY|||||||0.136|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.136
73800842|NCT02892331|147150668|SUPERIORITY|||||||0.262|||||||ANCOVA|||Comparison between the CON and the MOD-INT group||||0.262
73800843|NCT02892331|147150668|SUPERIORITY|||||||0.715|||||||ANCOVA|||Comparison between the MOD-INT group and the HIGH-INT groups||||0.715
73800844|NCT02892331|147150669|SUPERIORITY|||||||0.056|||||||ANCOVA|||Comparison between the CON and High-INT groups||||0.056
73800845|NCT02892331|147150669|SUPERIORITY|||||||0.349|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.349
73800846|NCT02892331|147150669|SUPERIORITY|||||||0.359|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.359
73800847|NCT02892331|147150670|SUPERIORITY|||||||0.224|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.224
73800848|NCT02892331|147150670|SUPERIORITY|||||||0.199|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.199
73800849|NCT02892331|147150670|SUPERIORITY|||||||0.952|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.952
73800850|NCT02892331|147150671|SUPERIORITY|||||||0.783|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.783
73800851|NCT02892331|147150671|SUPERIORITY|||||||0.098|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.098
73800852|NCT02892331|147150671|SUPERIORITY|||||||0.071|||||||ANCOVA|||Comparison between the MOD and HIGH-INT groups||||0.071
73800853|NCT02892331|147150672|SUPERIORITY|||||||0.94|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.940
73800854|NCT02892331|147150672|SUPERIORITY|||||||0.994|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.994
73800855|NCT02892331|147150672|SUPERIORITY|||||||0.94|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.940
73800856|NCT02892331|147150673|SUPERIORITY|||||||0.769|||||||ANCOVA|||Comparison of the CON and HIGH-INT groups||||0.769
73800857|NCT02892331|147150673|SUPERIORITY|||||||0.8|||||||ANCOVA|||Comparison of the CON and MOD-INT groups||||0.800
73800858|NCT02892331|147150673|SUPERIORITY|||||||0.769|||||||ANCOVA|||||||0.769
73800859|NCT02892331|147150674|SUPERIORITY|||||||1|||||||ANCOVA|||Comparison between the CON and the MOD groups||||1.000
73800860|NCT02892331|147150674|SUPERIORITY|||||||0.993|||||||ANCOVA|||Comparison of HIGH-INT and CON groups||||0.993
73800861|NCT02892331|147150674|SUPERIORITY|||||||0.994|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.994
73800862|NCT02892331|147150675|SUPERIORITY|||||||0.821|||||||ANCOVA|||Change in insulin sensitivity (CON vs. HIGH-INT)||||0.821
73800863|NCT02892331|147150675|SUPERIORITY|||||||0.985|||||||ANCOVA|||Change in insulin sensitivity (CON vs. MOD-INT)||||0.985
73800864|NCT02892331|147150675|SUPERIORITY|||||||0.856|||||||ANCOVA|||Change in insulin sensitivity (MOD-INT vs. HIGH-INT)||||0.856
73800865|NCT02892331|147150676|SUPERIORITY|||||||0.093|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.093
73800866|NCT02892331|147150676|SUPERIORITY|||||||0.033|||||||ANCOVA|||Comparison between the CON and the MOD-INT groups||||0.033
73800867|NCT02892331|147150676|SUPERIORITY|||||||0.602|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.602
73800868|NCT02892331|147150677|SUPERIORITY|||||||0.424|||||||ANCOVA|||Change in PGC1A (CON vs. HIGH-INT)||||0.424
73800869|NCT02892331|147150677|SUPERIORITY|||||||0.308|||||||ANCOVA|||Change in PGC1A (CON vs. MOD-INT)||||0.308
73800870|NCT02892331|147150677|SUPERIORITY|||||||0.844|||||||ANCOVA|||Change in PGC1a (MOD-INT vs. HIGH-INT)||||0.844
73800871|NCT02892331|147150677|SUPERIORITY|||||||0.135|||||||ANCOVA|||Change in citrate synthase (CON vs. HIGH-INT)||||0.135
73800872|NCT02892331|147150677|SUPERIORITY|||||||0.8|||||||ANCOVA|||Change in Citrate synthase (CON vs. MOD-INT)||||0.800
73800873|NCT02892331|147150677|SUPERIORITY|||||||0.195|||||||ANCOVA|||Change in citrate synthase||||0.195
73800874|NCT02892331|147150677|SUPERIORITY|||||||0.459|||||||ANCOVA|||Change in complex I||||0.459
73800875|NCT02892331|147150677|SUPERIORITY|||||||0.213|||||||ANCOVA|||Change in complex 1 (CON vs. MOD-INT groups)||||0.213
73800876|NCT02892331|147150677|SUPERIORITY|||||||0.971|||||||ANCOVA|||Change in complex II (MOD-INT vs. HIGH-INT)||||0.971
73800877|NCT02892331|147150677|SUPERIORITY|||||||0.634|||||||ANCOVA|||Change in complex III (CON vs. HIGH-INT)||||0.634
73800878|NCT02892331|147150677|SUPERIORITY|||||||0.919|||||||ANCOVA|||Change in Complex III (CON vs. MOD-INT groups)||||0.919
73800879|NCT02892331|147150677|SUPERIORITY|||||||0.574|||||||ANCOVA|||Change in complex III||||0.574
73800880|NCT02892331|147150677|SUPERIORITY|||||||0.295|||||||ANCOVA|||Change in Complex IV (CON vs. HIGH-INT)||||0.295
73800881|NCT02892331|147150677|SUPERIORITY|||||||0.097|||||||ANCOVA|||Change in complex IV (CON vs. MOD-INT)||||0.097
73800882|NCT02892331|147150677|SUPERIORITY|||||||0.468|||||||ANCOVA|||Change in complex IV||||0.468
73800883|NCT02892331|147150677|SUPERIORITY|||||||0.589|||||||ANCOVA|||Change in complex V||||0.589
73800884|NCT02892331|147150677|SUPERIORITY|||||||0.196|||||||ANCOVA|||Change in complex V (CON vs. MOD-INT)||||0.196
73800885|NCT02892331|147150677|SUPERIORITY|||||||0.436|||||||ANCOVA|||Change in Complex V (MOD-INT vs. HIGH-INT)||||0.436
73800886|NCT02892331|147150678|SUPERIORITY|||||||0.756|||||||ANCOVA|||Comparison of general health subscale (CON vs. HIGH INT)||||0.756
73800887|NCT02892331|147150678|SUPERIORITY|||||||0.115|||||||ANCOVA|||General Health Subscale (CON vs. MOD-INT)||||0.115
73800888|NCT02892331|147150678|SUPERIORITY|||||||0.225|||||||ANCOVA|||General Health Subscale (MOD-INT vs. HIGH-INT)||||0.225
73800889|NCT02892331|147150678|SUPERIORITY|||||||0.758|||||||ANCOVA|||Physical health Sub-scale (CON vs. HIGH-INT)||||0.758
73800890|NCT02892331|147150678|SUPERIORITY|||||||0.759|||||||ANCOVA|||Physical health subscale (CON vs. MOD-INT)||||0.759
73800891|NCT02892331|147150678|SUPERIORITY|||||||0.465|||||||ANCOVA|||Physical Health subscale (MOD-INT vs. HIGH-INT)||||0.465
73800892|NCT02892331|147150678|SUPERIORITY|||||||0.549|||||||ANCOVA|||Role Physical subscale (CON vs. HIGH-INT)||||0.549
73800893|NCT02892331|147150678|SUPERIORITY|||||||0.679|||||||ANCOVA|||Role Physical Subscale (CON vs. MOD-INT)||||0.679
73800894|NCT02892331|147150678|SUPERIORITY|||||||0.334|||||||ANCOVA|||Role Physical Subscale (MOD-INT vs. HIGH-INT)||||0.334
73800895|NCT02892331|147150678|SUPERIORITY|||||||0.273|||||||ANCOVA|||Bodily pain subscale (CON vs. HIGH-INT)||||0.273
73800896|NCT02892331|147150678|SUPERIORITY|||||||0.642|||||||ANCOVA|||Bodily pain subscale (CON vs. MOD-INT)||||0.642
73800897|NCT02892331|147150678|SUPERIORITY|||||||0.52|||||||ANCOVA|||Bodily Pain Subscale (MOD-INT vs. HIGH-INT)||||0.520
73800898|NCT02892331|147150678|SUPERIORITY|||||||0.46|||||||ANCOVA|||Vitality subscale (CON vs. HIGH-INT)||||0.460
73800899|NCT02892331|147150678|SUPERIORITY|||||||0.203|||||||ANCOVA|||Vitality sub-scale (CON vs. MOD-INT group)||||0.203
73800900|NCT02892331|147150678|SUPERIORITY|||||||0.058|||||||ANCOVA|||Vitality subscale (MOD-INT vs. HIGH-INT)||||0.058
73800901|NCT02892331|147150678|SUPERIORITY|||||||0.739|||||||ANCOVA|||Social Function subscale (CON vs. HIGH-INT)||||0.739
73800902|NCT02892331|147150678|SUPERIORITY|||||||0.059|||||||ANCOVA|||Social Function subscale (CON vs. MOD-INT)||||0.059
73800903|NCT02892331|147150678|SUPERIORITY|||||||0.038|||||||ANCOVA|||Social Function sub-scale (HIGH-INT vs. MOD-INT)||||0.0380
73800904|NCT02892331|147150678|SUPERIORITY|||||||0.95|||||||ANCOVA|||Comparison of mental health subscale (CON vs. HIGH-INT)||||0.950
73800905|NCT02892331|147150678|SUPERIORITY|||||||0.096|||||||ANCOVA|||Change in mental health subscale (CON Vs. MOD INT)||||0.096
73800906|NCT02892331|147150678|SUPERIORITY|||||||0.127|||||||ANCOVA|||Change in mental health subscale (MOD-INT vs. HIGH-INT)||||0.127
73800907|NCT02892331|147150678|SUPERIORITY|||||||0.373|||||||ANCOVA|||Change in role emotional subscale (CON vs HIGH-INT)||||0.373
73800908|NCT02892331|147150678|SUPERIORITY|||||||0.63|||||||ANCOVA|||Change in role emotional sub-scale||||0.630
73800909|NCT02892331|147150678|SUPERIORITY|||||||0.034|||||||ANCOVA|||Change in role emotional subscale (MOD vs. HIGH-INT)||||0.034
73800910|NCT02892331|147150678|SUPERIORITY|||||||0.07|||||||ANCOVA|||Change in role emotional subscale (CON vs. MOD-INT)||||0.070
73800911|NCT02892331|147150678|SUPERIORITY|||||||0.945|||||||ANCOVA|||Change in physical health sub-scale (MOD-INT vs. HIGH-INT)||||0.945
73800912|NCT02892331|147150679|SUPERIORITY|||||||0.65|||||||ANCOVA|||Change in the mental health sum scale (CON vs. HIGH-INT)||||0.650
73800913|NCT02892331|147150679|SUPERIORITY|||||||0.034|||||||ANCOVA|||Change in mental health (sum) subscale (MOD-INT vs. HIGH-INT)||||0.034
73800914|NCT02892331|147150679|SUPERIORITY|||||||0.33|||||||ANCOVA|||Change in physical health (sum)||||0.330
73800915|NCT02892331|147150679|SUPERIORITY|||||||0.297|||||||ANCOVA|||Change in physical health (sum) subscale||||0.297
73800916|NCT02892331|147150680|SUPERIORITY|||||||0.109|||||||ANCOVA|||Change in steps (CON vs. HIGH-INT)||||0.109
73800917|NCT02892331|147150680|SUPERIORITY|||||||0.099|||||||ANCOVA|||Change in steps (CON vs. MOD-INT)||||0.099
73800918|NCT02892331|147150680|SUPERIORITY|||||||0.947|||||||ANCOVA|||Change in steps (MOD-INT vs. HIGH-INT)||||0.947
73800919|NCT00610428|147150683|SUPERIORITY|||||||0.084||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival|||Survival time is defined as time to the first successful headache relief.||||0.0840
73800920|NCT00610428|147150683|SUPERIORITY|Survival time is defined as time to the first successful headache relief.||||||0.0383||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival|||||||0.0383
73800921|NCT02490631|147150709|SUPERIORITY|||||||0.456|||||||Chi-squared|||||||0.456
73800922|NCT02490631|147150710|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||.019
73800923|NCT03832686|147150712|OTHER|||||||0.86||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.86
73800924|NCT03832686|147150713|OTHER|||||||0.69||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.69
73894089|NCT00669409|147321130|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-11.7|19.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.9|-11.7|
73894090|NCT00669409|147321130|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-26.6|4.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.6|-26.6|
73894091|NCT00669409|147321130|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-30.5|10.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-30.5|
73894092|NCT00669409|147321131|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-19.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-19.4|
73894093|NCT00669409|147321131|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-34.3|-2.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.8|-34.3|
73894094|NCT00669409|147321131|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-12.6|19.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.0|-12.6|
73894095|NCT00669409|147321131|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-25.0|6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.2|-25.0|
73894096|NCT00669409|147321131|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-25.4|16.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.1|-25.4|
73800925|NCT03832686|147150714|OTHER|||||||0.47||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of Eating in Public Score||||0.47
73894097|NCT00669409|147321132|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-18.1|13.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.5|-18.1|
73894098|NCT00669409|147321132|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-33.6|-2.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.1|-33.6|
73894099|NCT00669409|147321132|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-17.2|14.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.4|-17.2|
73800926|NCT03832686|147150714|OTHER|||||||0.73||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of Normalcy of Diet score||||0.73
73800927|NCT03832686|147150715|OTHER|||||||0.65||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of MBSImP Oral score||||0.65
73800928|NCT03832686|147150715|OTHER|||||||0.24||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of MBSImP Pharyngeal score||||0.24
73800929|NCT03832686|147150716|OTHER|||||||0.53||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.53
73800930|NCT03832686|147150717|OTHER|||||||0.5||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.50
73800931|NCT05479435|147150718|OTHER|||||||0.83|||||||Kruskal-Wallis|||||||0.830
73800932|NCT05479435|147150719|OTHER|||||||0.654|||||||ANCOVA|||||||0.654
73800933|NCT05479435|147150720|OTHER|||||||0.803|||||||ANCOVA|||||||0.803
73800934|NCT05479435|147150721|OTHER|||||||0.398|||||||ANCOVA|||||||0.398
73800935|NCT05479435|147150722|OTHER|||||||0.132|||||||Kruskal-Wallis|||||||0.132
73800936|NCT05479435|147150723|OTHER|||||||0.991|||||||Kruskal-Wallis|||||||0.991
73800937|NCT05479435|147150724|OTHER|||||||0.278|||||||Kruskal-Wallis|||||||0.278
73800938|NCT05479435|147150725|OTHER|||||||0.479|||||||ANCOVA|||||||0.479
73800939|NCT05479435|147150726|OTHER|||||||0.849|||||||Kruskal-Wallis|||||||0.849
73800940|NCT05479435|147150727|OTHER|||||||0.504|||||||Kruskal-Wallis|||||||0.504
73800941|NCT05479435|147150728|OTHER|||||||0.017|||||||ANCOVA|||||||0.017
73894100|NCT00669409|147321132|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.2|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-26.7|4.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.4|-26.7|
73894101|NCT00669409|147321132|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-25.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-46.5|-5.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.0|-46.5|
73894102|NCT00669409|147321133|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-16.6|15.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.0|-16.6|
73894103|NCT00669409|147321133|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.1|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-32.8|-1.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-32.8|
73800942|NCT05479435|147150729|OTHER|||||||0.025|||||||Kruskal-Wallis|||||||0.025
73800943|NCT05479435|147150730|OTHER|||||||0.016|||||||ANCOVA|||||||0.016
73800944|NCT05479435|147150731|OTHER|||||||0.041|||||||ANCOVA|||||||0.041
73800945|NCT05479435|147150732|OTHER|||||||0.352|||||||Kruskal-Wallis|||||||0.352
73800946|NCT05479435|147150733|OTHER|||||||0.39|||||||Kruskal-Wallis|||||||0.390
73800947|NCT05479435|147150734|OTHER|||||||0.928|||||||ANCOVA|||||||0.928
73800948|NCT05479435|147150735|OTHER|||||||0.558|||||||Kruskal-Wallis|||||||0.558
73800949|NCT05479435|147150736|OTHER|||||||0.133|||||||Kruskal-Wallis|||||||0.133
73800950|NCT05479435|147150737|OTHER|||||||0.367|||||||Kruskal-Wallis|||||||0.367
73800951|NCT05479435|147150738|OTHER|||||||0.631|||||||ANCOVA|||||||0.631
73800952|NCT05479435|147150739|OTHER|||||||0.056|||||||ANCOVA|||||||0.056
73800953|NCT05479435|147150740|OTHER|||||||0.979|||||||ANCOVA|||||||0.979
73800954|NCT05479435|147150741|OTHER|||||||0.377|||||||ANCOVA|||||||0.377
73800955|NCT05479435|147150742|OTHER|||||||0.979|||||||ANCOVA|||||||0.979
73800956|NCT05479435|147150743|OTHER|||||||0.055|||||||ANCOVA|||||||0.055
73800957|NCT03851406|147150768|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||> 0.99
73800958|NCT03851406|147150769|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||> 0.99
73800959|NCT03851406|147150770|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||> 0.99
73800960|NCT03851406|147150770|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||> 0.99
73800961|NCT03851406|147150771|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.38
73800962|NCT03851406|147150771|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.38
73800963|NCT03851406|147150772|OTHER|||||||0.25||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.25
73800964|NCT03851406|147150772|OTHER|||||||0.63||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.63
73800965|NCT03851406|147150773|OTHER|||||||0.88||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.88
73800966|NCT03851406|147150773|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||>0.99
73800967|NCT03851406|147150774|OTHER|||||||0.88||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.88
73894104|NCT00669409|147321133|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.0|10.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.6|-21.0|
73800968|NCT03851406|147150774|OTHER|||||||0.25||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.25
73800969|NCT03851406|147150775|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||>0.99
73800970|NCT03851406|147150775|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||>0.99
73800971|NCT03851406|147150776|OTHER|||||||0.75||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.75
73800972|NCT03851406|147150776|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.38
73800973|NCT03511105|147150778|OTHER||Absolute Difference|-30.46|STANDARD_ERROR_OF_MEAN|48.662|||TWO_SIDED|95.0|-127.07|65.51|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI has been presented.|||65.51|-127.07|
73800974|NCT03511105|147150778|OTHER||Percentage change|8.73|STANDARD_ERROR_OF_MEAN|13.453|||TWO_SIDED|95.0|-21.41|31.3|||||Percentage change on GSK2798745 relative to placebo has been presented.|||31.30|-21.41|
73800975|NCT03511105|147150779|OTHER||Absolute Difference|-4.26|STANDARD_ERROR_OF_MEAN|13.679|||TWO_SIDED|95.0|-31.49|22.87|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.|||22.87|-31.49|
73800976|NCT03511105|147150779|OTHER||Percentage change|7.31|STANDARD_ERROR_OF_MEAN|22.837|||TWO_SIDED|95.0|-48.2|41.64|||||Percentage change on GSK2798745 relative to placebo has been presented.|||41.64|-48.20|
73800977|NCT03511105|147150780|OTHER||Absolute Difference|-0.06|STANDARD_ERROR_OF_MEAN|3.178|||TWO_SIDED|95.0|-6.28|6.2|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.|||6.20|-6.28|
73800978|NCT03511105|147150780|OTHER||Percentage change|0.1|STANDARD_ERROR_OF_MEAN|5.429|||TWO_SIDED|95.0|-11.15|10.16|||||Percentage change on GSK2798745 relative to placebo has been presented.|||10.16|-11.15|
73800979|NCT02810457|147150804|EQUIVALENCE|A 90% CI for the ORR ratio between FKB238 and Avastin was estimated and compared to the margin (0.73 to 1.38), which was deemed to represent a clinically acceptable difference with respect to ORR. If the 90% CI was within the equivalence margin (0.73 to 1.38), an equivalence between FKB238 and Avastin, with respect to the ORR, was confirmed.|Ratio in ORR|0.96|||||TWO_SIDED|90.0|0.86|1.08||||||||1.08|0.86|
73800980|NCT02810457|147150805|OTHER|Ratio in ORR analysis of FKB238 versus Avastin.|Ratio in ORR|0.94|||||TWO_SIDED|90.0|0.83|1.06||||||Comparison between groups: Risk ratio in ORR at Week 19 by BICR.||1.06|0.83|
73800981|NCT02810457|147150806|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.82|1.16|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, Eastern Cooperative Oncology Group (ECOG) performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.16|0.82|
73800982|NCT02810457|147150807|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.96|1.45|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.45|0.96|
73800983|NCT02810457|147150808|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.74|1.23|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.23|0.74|
73800984|NCT02810457|147150809|OTHER|Comparison between arms: Odds ratio.|Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.64|1.58|||||Odds ratio \>1 favors FKB238.|The DCR was compared between treatment arms using logistic regression adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age).||1.58|0.64|
73800985|NCT03861390|147150826|OTHER|||||||0.24||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.24
73800986|NCT03861390|147150827|OTHER|||||||0.17||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.17
73800987|NCT03861390|147150828|OTHER|||||||0.7||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.70
73800988|NCT03861390|147150828|OTHER|||||||0.37||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.37
73800989|NCT03861390|147150829|OTHER|||||||0.77||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.77
73800990|NCT03861390|147150829|OTHER|||||||0.48||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.48
73800991|NCT03861390|147150830|OTHER|||||||0.96||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.96
73800992|NCT03861390|147150830|OTHER|||||||0.91||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.91
73800993|NCT03861390|147150831|OTHER|||||||0.46||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.46
73800994|NCT03861390|147150831|OTHER|||||||0.46||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.46
73894105|NCT00669409|147321133|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-28.3|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-28.3|
73800995|NCT03861390|147150832|OTHER|||||||0.82||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.82
73800996|NCT03861390|147150832|OTHER|The a priori threshold for statistical significance is \< 0.05.||||||0.99|||||||Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.99
73800997|NCT03861390|147150833|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.38
73800998|NCT03861390|147150833|OTHER|||||||0.84||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.84
73800999|NCT03861390|147150834|OTHER|||||||0.49||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.49
73801000|NCT03861390|147150834|OTHER|||||||0.52||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.52
73801001|NCT01217112|147150836|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.044||0.766|TWO_SIDED|90.0|-0.09|0.06|||ANCOVA|||Data was analysed by analysis of covariance (ANCOVA). The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.06|-0.09|0.766
73801002|NCT01217112|147150836|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.043||0.424|TWO_SIDED|90.0|-0.04|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.04|0.424
73801003|NCT01217112|147150836|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.041||0.412|TWO_SIDED|90.0|-0.1|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.10|0.412
73801004|NCT01217112|147150836|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.043||0.668|TWO_SIDED|90.0|-0.05|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.05|0.668
73801005|NCT01217112|147150837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.046||0.978|TWO_SIDED|90.0|-0.08|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.08|0.978
73801006|NCT01217112|147150837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.045||0.864|TWO_SIDED|90.0|-0.08|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.07|-0.08|0.864
73801007|NCT01217112|147150837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.537|TWO_SIDED|90.0|-0.12|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.05|-0.12|0.537
73801008|NCT01217112|147150837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.045||0.26|TWO_SIDED|90.0|-0.02|0.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.13|-0.02|0.260
73894106|NCT00669409|147321133|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.9|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-49.6|-8.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-8.2|-49.6|
73801009|NCT01217112|147150838|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.088|TWO_SIDED|90.0|-0.61|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.01|-0.61|0.088
73894107|NCT00669409|147321134|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-16.8|14.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.8|-16.8|
73894108|NCT00669409|147321134|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-35.0|-3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.5|-35.0|
73894109|NCT00669409|147321134|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.8|9.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.8|-21.8|
73894110|NCT00669409|147321134|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-28.0|3.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.2|-28.0|
73894111|NCT00669409|147321134|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-50.6|-9.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-9.1|-50.6|
73894112|NCT00669409|147321135|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-11.9|19.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.7|-11.9|
73894113|NCT00669409|147321135|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-35.1|-3.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.6|-35.1|
73894114|NCT00669409|147321135|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.3|10.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.3|-21.3|
73894115|NCT00669409|147321135|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-27.8|3.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.4|-27.8|
73801010|NCT01217112|147150838|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.177||0.583|TWO_SIDED|90.0|-0.2|0.39|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.39|-0.20|0.583
73801011|NCT01217112|147150838|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.169||0.388|TWO_SIDED|90.0|-0.14|0.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.43|-0.14|0.388
73801012|NCT01217112|147150838|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.58|TWO_SIDED|90.0|-0.19|0.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.38|-0.19|0.580
73894116|NCT00669409|147321135|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-25.0|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-45.8|-4.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.3|-45.8|
73894117|NCT00669409|147321136|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-9.1|22.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||22.5|-9.1|
73894118|NCT00669409|147321136|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-31.7|-0.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.2|-31.7|
73894119|NCT00669409|147321136|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-18.5|13.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.2|-18.5|
73801013|NCT01217112|147150839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.198||0.829|TWO_SIDED|90.0|-0.29|0.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.37|-0.29|0.829
73894120|NCT00669409|147321136|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-25.9|5.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.3|-25.9|
73894121|NCT00669409|147321136|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.5|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-44.2|-2.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.7|-44.2|
73894122|NCT00669409|147321137|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.6|27.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.0|-4.6|
73894123|NCT00669409|147321137|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.0|1.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.5|-30.0|
73894124|NCT00669409|147321137|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.3|17.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.3|-14.3|
73801014|NCT01217112|147150839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.196||0.575|TWO_SIDED|90.0|-0.22|0.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.44|-0.22|0.575
73801015|NCT01217112|147150839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.203||0.356|TWO_SIDED|90.0|-0.15|0.53|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.53|-0.15|0.356
73801016|NCT01217112|147150839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.188||0.472|TWO_SIDED|90.0|-0.18|0.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.45|-0.18|0.472
73801017|NCT01217112|147150840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.181||0.115|TWO_SIDED|90.0|-0.59|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.59|0.115
73801018|NCT01217112|147150840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.177||0.782|TWO_SIDED|90.0|-0.25|0.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.35|-0.25|0.782
73801019|NCT01217112|147150840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.173||0.902|TWO_SIDED|90.0|-0.27|0.31|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.31|-0.27|0.902
73801020|NCT01217112|147150840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.166||0.993|TWO_SIDED|90.0|-0.28|0.28|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.28|-0.28|0.993
73801021|NCT01217112|147150841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.143||0.956|TWO_SIDED|90.0|-0.23|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.25|-0.23|0.956
73801022|NCT01217112|147150841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.144||0.705|TWO_SIDED|90.0|-0.19|0.3|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.30|-0.19|0.705
73801023|NCT01217112|147150841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.148||0.466|TWO_SIDED|90.0|-0.14|0.36|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.36|-0.14|0.466
73801024|NCT01217112|147150841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.136||0.876|TWO_SIDED|90.0|-0.21|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.25|-0.21|0.876
73801025|NCT01217112|147150842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.034||0.408|TWO_SIDED|90.0|-0.03|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.03|0.408
73801026|NCT01217112|147150842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.032||0.714|TWO_SIDED|90.0|-0.04|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.07|-0.04|0.714
73894125|NCT00669409|147321137|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-21.9|9.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.3|-21.9|
73894126|NCT00669409|147321137|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-40.5|1.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.0|-40.5|
73801027|NCT01217112|147150842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.032||0.267|TWO_SIDED|90.0|-0.09|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.02|-0.09|0.267
73801028|NCT01217112|147150842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.032||0.484|TWO_SIDED|90.0|-0.03|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.03|0.484
73801029|NCT01217112|147150843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.039||0.56|TWO_SIDED|90.0|-0.09|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.09|0.560
73894127|NCT00669409|147321138|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-5.0|26.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.6|-5.0|
73801030|NCT01217112|147150843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.037||0.956|TWO_SIDED|90.0|-0.06|0.06|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.06|-0.06|0.956
73801031|NCT01217112|147150843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.039||0.403|TWO_SIDED|90.0|-0.1|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.10|0.403
73801032|NCT01217112|147150843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.037||0.617|TWO_SIDED|90.0|-0.04|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.04|0.617
73801033|NCT01217112|147150844|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.108||0.815|TWO_SIDED|90.0|-0.16|0.21|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.21|-0.16|0.815
73801034|NCT01217112|147150844|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.105||0.418|TWO_SIDED|90.0|-0.09|0.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.26|-0.09|0.418
73801035|NCT01217112|147150844|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.111||0.236|TWO_SIDED|90.0|-0.05|0.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.32|-0.05|0.236
73801036|NCT01217112|147150844|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.103||0.556|TWO_SIDED|90.0|-0.11|0.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.23|-0.11|0.556
73801037|NCT01217112|147150845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.241||0.329|TWO_SIDED|90.0|-0.64|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.64|0.329
73801038|NCT01217112|147150845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.236||0.232|TWO_SIDED|90.0|-0.11|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.68|-0.11|0.232
73801039|NCT01217112|147150845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.222||0.164|TWO_SIDED|90.0|-0.06|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.68|-0.06|0.164
73801040|NCT01217112|147150845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.232||0.302|TWO_SIDED|90.0|-0.15|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.63|-0.15|0.302
73801041|NCT01217112|147150846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.231||0.614|TWO_SIDED|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.27|-0.50|0.614
73801042|NCT01217112|147150846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.227||0.669|TWO_SIDED|90.0|-0.28|0.48|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.48|-0.28|0.669
73894128|NCT00669409|147321138|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.0|1.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-30.0|
73894129|NCT00669409|147321138|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.6|17.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.0|-14.6|
73801043|NCT01217112|147150846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.24||0.621|TWO_SIDED|90.0|-0.28|0.52|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.52|-0.28|0.621
73801044|NCT01217112|147150846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.222||0.867|TWO_SIDED|90.0|-0.33|0.41|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.41|-0.33|0.867
73801045|NCT01217112|147150847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.55|STANDARD_ERROR_OF_MEAN|2.624||0.335|TWO_SIDED|90.0|-1.84|6.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.95|-1.84|0.335
73894130|NCT00669409|147321138|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-21.0|10.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.2|-21.0|
73801046|NCT01217112|147150847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.36|STANDARD_ERROR_OF_MEAN|2.545||0.358|TWO_SIDED|90.0|-1.9|6.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.62|-1.90|0.358
73801047|NCT01217112|147150847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|2.406||0.9|TWO_SIDED|90.0|-3.72|4.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.33|-3.72|0.900
73801048|NCT01217112|147150847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.02|STANDARD_ERROR_OF_MEAN|2.486||0.019|TWO_SIDED|90.0|1.86|10.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.19|1.86|0.019
73801049|NCT01217112|147150848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.245||0.325|TWO_SIDED|90.0|-0.65|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.65|0.325
73801050|NCT01217112|147150848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.238||0.438|TWO_SIDED|90.0|-0.21|0.59|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.59|-0.21|0.438
73801051|NCT01217112|147150848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.226||0.701|TWO_SIDED|90.0|-0.29|0.47|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.47|-0.29|0.701
73801052|NCT01217112|147150848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.232||0.624|TWO_SIDED|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.27|-0.50|0.624
73801053|NCT01217112|147150849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.058||0.233|TWO_SIDED|90.0|-0.17|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.17|0.233
73801054|NCT01217112|147150849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.056||0.727|TWO_SIDED|90.0|-0.07|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.07|0.727
73801055|NCT01217112|147150849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.053||0.593|TWO_SIDED|90.0|-0.06|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.12|-0.06|0.593
73801056|NCT01217112|147150849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.056||0.075|TWO_SIDED|90.0|-0.2|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.01|-0.20|0.075
73801057|NCT01217112|147150850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.084||0.236|TWO_SIDED|90.0|-0.04|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.24|-0.04|0.236
73801058|NCT01217112|147150850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.082||0.579|TWO_SIDED|90.0|-0.09|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.18|-0.09|0.579
73801059|NCT01217112|147150850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.077||0.837|TWO_SIDED|90.0|-0.15|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.15|0.837
73801060|NCT01217112|147150850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.081||0.467|TWO_SIDED|90.0|-0.08|0.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.19|-0.08|0.467
73801061|NCT01217112|147150851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.613||0.533|TWO_SIDED|90.0|-1.41|0.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.64|-1.41|0.533
73801062|NCT01217112|147150851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.585||0.804|TWO_SIDED|90.0|-0.84|1.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.13|-0.84|0.804
73801063|NCT01217112|147150851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.556||0.916|TWO_SIDED|90.0|-0.87|0.99|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.99|-0.87|0.916
73801064|NCT01217112|147150851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.583||0.04|TWO_SIDED|90.0|-2.2|-0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.25|-2.20|0.040
73894131|NCT00669409|147321138|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-35.3|6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.2|-35.3|
73894132|NCT00669409|147321139|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|10.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-5.5|26.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.1|-5.5|
73801065|NCT01217112|147150852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|10.838||0.366|TWO_SIDED|90.0|-28.06|8.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||8.27|-28.06|0.366
73801066|NCT01217112|147150852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|10.692||0.844|TWO_SIDED|90.0|-15.81|20.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||20.03|-15.81|0.844
73801067|NCT01217112|147150852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.96|STANDARD_ERROR_OF_MEAN|10.026||0.118|TWO_SIDED|90.0|-32.76|0.84|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.84|-32.76|0.118
73801068|NCT01217112|147150852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.67|STANDARD_ERROR_OF_MEAN|10.256||0.518|TWO_SIDED|90.0|-23.86|10.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.51|-23.86|0.518
73801069|NCT01217112|147150853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.294||0.576|TWO_SIDED|90.0|-0.66|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.33|-0.66|0.576
73801070|NCT01217112|147150853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.283||0.648|TWO_SIDED|90.0|-0.6|0.34|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.34|-0.60|0.648
73801071|NCT01217112|147150853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.269||0.447|TWO_SIDED|90.0|-0.66|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.24|-0.66|0.447
73801072|NCT01217112|147150853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.283||0.273|TWO_SIDED|90.0|-0.79|0.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.16|-0.79|0.273
73801073|NCT01217112|147150854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.097||0.615|TWO_SIDED|90.0|-2.4|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.29|-2.40|0.615
73894133|NCT00669409|147321139|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-27.0|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-27.0|
73801074|NCT01217112|147150854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.973||0.342|TWO_SIDED|90.0|-0.7|2.57|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.57|-0.70|0.342
73801075|NCT01217112|147150854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.934||0.314|TWO_SIDED|90.0|-2.52|0.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.62|-2.52|0.314
73801076|NCT01217112|147150854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.964||0.889|TWO_SIDED|90.0|-1.48|1.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.75|-1.48|0.889
73801077|NCT01217112|147150855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|50.89|STANDARD_ERROR_OF_MEAN|168.459||0.764|TWO_SIDED|90.0|-232.02|333.8|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||333.80|-232.02|0.764
73801078|NCT01217112|147150855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-70.76|STANDARD_ERROR_OF_MEAN|156.72||0.654|TWO_SIDED|90.0|-333.96|192.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||192.44|-333.96|0.654
73894134|NCT00669409|147321139|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-13.3|18.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.3|-13.3|
73894135|NCT00669409|147321139|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-19.2|11.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.9|-19.2|
73894136|NCT00669409|147321139|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-34.4|7.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.0|-34.4|
73894137|NCT00669409|147321140|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|11.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.8|26.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.8|-4.8|
73894138|NCT00669409|147321140|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-8.1|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-23.9|7.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.6|-23.9|
73894139|NCT00669409|147321140|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|1.8|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.0|17.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.6|-14.0|
73894140|NCT00669409|147321140|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-19.2|12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-19.2|
73894141|NCT00669409|147321140|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-12.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-33.5|8.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.0|-33.5|
73801079|NCT01217112|147150855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-111.5|STANDARD_ERROR_OF_MEAN|146.276||0.45|TWO_SIDED|90.0|-357.17|134.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||134.16|-357.17|0.450
73801080|NCT01217112|147150855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|97.42|STANDARD_ERROR_OF_MEAN|149.124||0.517|TWO_SIDED|90.0|-153.02|347.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||347.86|-153.02|0.517
73801081|NCT01217112|147150856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|40.94||0.84|TWO_SIDED|90.0|-60.28|76.94|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||76.94|-60.28|0.840
73894142|NCT00669409|147321141|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|11.4|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.4|27.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.2|-4.4|
73894143|NCT00669409|147321141|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-21.2|10.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.3|-21.2|
73894144|NCT00669409|147321141|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|4.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-11.2|20.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.4|-11.2|
73894145|NCT00669409|147321141|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-20.3|10.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-20.3|
73894146|NCT00669409|147321141|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.1|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-24.9|16.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.6|-24.9|
73894147|NCT00669409|147321142|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-20.7|12.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.3|-20.7|
73894148|NCT00669409|147321142|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-19.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.6|-3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.0|-35.6|
73894149|NCT00669409|147321142|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-20.5|12.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.1|-20.5|
73894150|NCT00669409|147321142|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-15.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-31.9|0.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.3|-31.9|
73894151|NCT00669409|147321142|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-35.1|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-56.4|-13.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-13.8|-56.4|
73894152|NCT00669409|147321143|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-21.2|11.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.8|-21.2|
73894153|NCT00669409|147321143|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-33.0|-0.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.4|-33.0|
73894154|NCT00669409|147321143|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-13.5|19.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.1|-13.5|
73894155|NCT00669409|147321143|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-29.2|3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.0|-29.2|
73894156|NCT00669409|147321143|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-32.8|9.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.7|-32.8|
73894157|NCT00669409|147321144|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-22.9|10.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.1|-22.9|
73894158|NCT00669409|147321144|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.7|-3.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.1|-35.7|
73894159|NCT00669409|147321144|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-15.0|17.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.6|-15.0|
73894160|NCT00669409|147321144|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-27.1|5.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.1|-27.1|
73894161|NCT00669409|147321144|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-26.0|16.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-26.0|
73894162|NCT00669409|147321145|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-21.1|11.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.9|-21.1|
73894163|NCT00669409|147321145|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.6|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.9|-3.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-35.9|
73894164|NCT00669409|147321145|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-20.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-20.4|
73894165|NCT00669409|147321145|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-30.0|2.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.3|-30.0|
73894166|NCT00669409|147321145|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-48.8|-6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.2|-48.8|
73801082|NCT01217112|147150856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.31|STANDARD_ERROR_OF_MEAN|39.521||0.834|TWO_SIDED|90.0|-57.92|74.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||74.55|-57.92|0.834
73894167|NCT00669409|147321146|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-19.6|13.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.4|-19.6|
73894168|NCT00669409|147321146|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.8|-3.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.1|-35.8|
73894169|NCT00669409|147321146|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-25.4|7.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.2|-25.4|
73894170|NCT00669409|147321146|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-32.8|-0.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.5|-32.8|
73894171|NCT00669409|147321146|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-32.6|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-53.9|-11.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-11.4|-53.9|
73894172|NCT00669409|147321147|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-20.1|12.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.9|-20.1|
73894173|NCT00669409|147321147|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-37.9|-5.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.2|-37.9|
73894174|NCT00669409|147321147|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-25.7|6.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.9|-25.7|
73894175|NCT00669409|147321147|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-31.5|0.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.7|-31.5|
73894176|NCT00669409|147321147|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-32.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-53.7|-11.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-11.2|-53.7|
73894177|NCT00669409|147321148|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-17.0|16.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.0|-17.0|
73894178|NCT00669409|147321148|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-37.6|-4.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.9|-37.6|
73894179|NCT00669409|147321148|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-24.1|8.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.5|-24.1|
73894180|NCT00669409|147321148|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-32.2|0.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.0|-32.2|
73894181|NCT00669409|147321148|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-26.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-48.1|-5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.5|-48.1|
73894182|NCT00669409|147321149|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-12.8|20.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.2|-12.8|
73894183|NCT00669409|147321149|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-34.8|-2.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.2|-34.8|
73894184|NCT00669409|147321149|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-21.7|11.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.0|-21.7|
73894185|NCT00669409|147321149|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-30.1|2.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.1|-30.1|
73801083|NCT01217112|147150856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.62|STANDARD_ERROR_OF_MEAN|39.044||0.767|TWO_SIDED|90.0|-77.06|53.81|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||53.81|-77.06|0.767
73801084|NCT01217112|147150856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.51|STANDARD_ERROR_OF_MEAN|39.68||0.289|TWO_SIDED|90.0|-23.99|109.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||109.01|-23.99|0.289
73894186|NCT00669409|147321149|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-46.0|-3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.5|-46.0|
73894187|NCT00669409|147321150|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.5|25.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.5|-7.5|
73894188|NCT00669409|147321150|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-32.0|0.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.6|-32.0|
73894189|NCT00669409|147321150|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-16.7|15.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.9|-16.7|
73894190|NCT00669409|147321150|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-25.5|6.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.7|-25.5|
73894191|NCT00669409|147321150|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-42.0|0.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.5|-42.0|
73894192|NCT00669409|147321151|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-8.4|24.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||24.6|-8.4|
73894193|NCT00669409|147321151|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-32.6|0.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.0|-32.6|
73894194|NCT00669409|147321151|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-17.1|15.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.5|-17.1|
73894195|NCT00669409|147321151|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-24.4|7.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.8|-24.4|
73894196|NCT00669409|147321151|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-38.0|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-38.0|
73894197|NCT00669409|147321152|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|8.8|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.7|25.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.3|-7.7|
73894198|NCT00669409|147321152|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.9|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-29.2|3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.5|-29.2|
73894199|NCT00669409|147321152|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-15.8|16.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.8|-15.8|
73801085|NCT01217112|147150857|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.106||0.569|TWO_SIDED|90.0|-0.24|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.12|-0.24|0.569
73801086|NCT01217112|147150857|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.101||0.984|TWO_SIDED|90.0|-0.17|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.17|0.984
73801087|NCT01217112|147150857|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.098||0.176|TWO_SIDED|90.0|-0.3|0.03|||ANCOVA|||v Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.30|0.176
73801088|NCT01217112|147150857|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.099||0.895|TWO_SIDED|90.0|-0.15|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.18|-0.15|0.895
73801089|NCT01217112|147150858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.745||0.871|TWO_SIDED|90.0|-1.13|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-1.13|0.871
73801090|NCT01217112|147150858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.721||0.826|TWO_SIDED|90.0|-1.05|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-1.05|0.826
73801091|NCT01217112|147150858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.703||0.693|TWO_SIDED|90.0|-1.46|0.9|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.90|-1.46|0.693
73801092|NCT01217112|147150858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.722||0.536|TWO_SIDED|90.0|-0.76|1.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.66|-0.76|0.536
73801093|NCT01217112|147150859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|8.633||0.878|TWO_SIDED|90.0|-15.8|13.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||13.13|-15.80|0.878
73801094|NCT01217112|147150859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|8.377||0.919|TWO_SIDED|90.0|-13.18|14.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||14.89|-13.18|0.919
73801095|NCT01217112|147150859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.72|STANDARD_ERROR_OF_MEAN|7.989||0.557|TWO_SIDED|90.0|-8.67|18.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||18.11|-8.67|0.557
73801096|NCT01217112|147150859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|8.328||0.275|TWO_SIDED|90.0|-4.76|23.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||23.16|-4.76|0.275
73801097|NCT01217112|147150860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.45|STANDARD_ERROR_OF_MEAN|16.445||0.528|TWO_SIDED|90.0|-17.12|38.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||38.01|-17.12|0.528
73801098|NCT01217112|147150860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|15.825||0.99|TWO_SIDED|90.0|-26.32|26.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||26.72|-26.32|0.990
73801099|NCT01217112|147150860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|15.369||0.776|TWO_SIDED|90.0|-21.37|30.15|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||30.15|-21.37|0.776
73801100|NCT01217112|147150860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|44.51|STANDARD_ERROR_OF_MEAN|15.834||0.007|TWO_SIDED|90.0|17.98|71.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||71.05|17.98|0.007
73801101|NCT01217112|147150861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.536||0.717|TWO_SIDED|90.0|-0.7|1.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.09|-0.70|0.717
73801102|NCT01217112|147150861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.531||0.218|TWO_SIDED|90.0|-0.23|1.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.55|-0.23|0.218
73894200|NCT00669409|147321152|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-23.6|8.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.6|-23.6|
73894201|NCT00669409|147321152|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-37.0|5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.5|-37.0|
73894202|NCT00669409|147321153|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.4|25.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.5|-7.4|
73894203|NCT00669409|147321153|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-27.1|5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.5|-27.1|
73894204|NCT00669409|147321153|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-16.9|15.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.7|-16.9|
73894205|NCT00669409|147321153|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-23.9|8.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.4|-23.9|
73894206|NCT00669409|147321153|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-37.1|5.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-37.1|
73894207|NCT00669409|147321154|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.4|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-5.1|27.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.9|-5.1|
73894208|NCT00669409|147321154|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-24.4|8.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.2|-24.4|
73894209|NCT00669409|147321154|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-14.2|18.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.4|-14.2|
73894210|NCT00669409|147321154|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|8.16|||TWO_SIDED|95.0|-24.3|8.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.0|-24.3|
73894211|NCT00669409|147321154|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-27.6|14.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.9|-27.6|
73894212|NCT00669409|147321155|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-21.6|11.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.8|-21.6|
73894213|NCT00669409|147321155|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.1|-2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-36.1|
73894214|NCT00669409|147321155|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-21.8|11.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.4|-21.8|
73894215|NCT00669409|147321155|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.6|1.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.2|-31.6|
73894216|NCT00669409|147321155|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-40.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-62.6|-19.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-19.0|-62.6|
73894217|NCT00669409|147321156|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-20.9|12.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.5|-20.9|
73894218|NCT00669409|147321156|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-32.6|0.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.7|-32.6|
73894219|NCT00669409|147321156|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.2|20.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.1|-13.2|
73894220|NCT00669409|147321156|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-28.4|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-28.4|
73894221|NCT00669409|147321156|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-38.8|4.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.8|-38.8|
73894222|NCT00669409|147321157|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-22.2|11.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.2|-22.2|
73894223|NCT00669409|147321157|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.1|-2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-36.1|
73894224|NCT00669409|147321157|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-15.6|17.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.7|-15.6|
73894225|NCT00669409|147321157|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-28.0|4.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.8|-28.0|
73894226|NCT00669409|147321157|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-30.1|13.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.5|-30.1|
73894227|NCT00669409|147321158|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-20.6|12.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.8|-20.6|
73894228|NCT00669409|147321158|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-35.6|-2.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.3|-35.6|
73894229|NCT00669409|147321158|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-19.6|13.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.7|-19.6|
73894230|NCT00669409|147321158|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-30.9|1.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.9|-30.9|
73894231|NCT00669409|147321158|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.4|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-51.2|-7.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.6|-51.2|
73894232|NCT00669409|147321159|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-16.3|17.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.1|-16.3|
73894233|NCT00669409|147321159|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-35.4|-2.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.2|-35.4|
73894234|NCT00669409|147321159|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-24.1|9.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.1|-24.1|
73894235|NCT00669409|147321159|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.9|0.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.9|-31.9|
73894236|NCT00669409|147321159|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.3|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-53.1|-9.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-9.5|-53.1|
73894237|NCT00669409|147321160|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-16.9|16.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-16.9|
73894238|NCT00669409|147321160|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.7|-3.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.4|-36.7|
73894239|NCT00669409|147321160|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-24.2|9.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-24.2|
73894240|NCT00669409|147321160|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.4|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-29.8|3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.0|-29.8|
73894241|NCT00669409|147321160|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-33.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-55.6|-12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-12.0|-55.6|
73894242|NCT00669409|147321161|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-12.9|20.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.4|-12.9|
73894243|NCT00669409|147321161|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.5|-3.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-36.5|
73894244|NCT00669409|147321161|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-23.3|10.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.0|-23.3|
73894245|NCT00669409|147321161|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.2|1.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-31.2|
73894246|NCT00669409|147321161|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.2|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-50.0|-6.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.4|-50.0|
73894247|NCT00669409|147321162|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-9.4|24.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||24.0|-9.4|
73801103|NCT01217112|147150861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.514||0.378|TWO_SIDED|90.0|-0.4|1.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.32|-0.40|0.378
73801104|NCT01217112|147150861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.532||0.361|TWO_SIDED|90.0|-0.4|1.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.38|-0.40|0.361
73801105|NCT01217112|147150862|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.417|TWO_SIDED|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.01|0.417
73801106|NCT01217112|147150862|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.34|TWO_SIDED|90.0|-0.01|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.01|0.340
73801107|NCT01217112|147150862|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.013||0.915|TWO_SIDED|90.0|-0.02|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.02|-0.02|0.915
73801108|NCT01217112|147150862|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.465|TWO_SIDED|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.01|0.465
73801109|NCT01217112|147150863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|1.616||0.646|TWO_SIDED|90.0|-1.96|3.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.45|-1.96|0.646
73894248|NCT00669409|147321162|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-34.4|-1.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.2|-34.4|
73894249|NCT00669409|147321162|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-20.0|13.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.2|-20.0|
73894250|NCT00669409|147321162|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-29.9|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-29.9|
73801110|NCT01217112|147150863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.598||0.219|TWO_SIDED|90.0|-0.69|4.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.66|-0.69|0.219
73801111|NCT01217112|147150863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|1.563||0.307|TWO_SIDED|90.0|-1.0|4.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.23|-1.00|0.307
73801112|NCT01217112|147150863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.52|STANDARD_ERROR_OF_MEAN|1.612||0.348|TWO_SIDED|90.0|-1.17|4.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.22|-1.17|0.348
73801113|NCT01217112|147150864|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|1.299||0.187|TWO_SIDED|90.0|-0.44|3.91|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.91|-0.44|0.187
73801114|NCT01217112|147150864|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|1.28||0.578|TWO_SIDED|90.0|-1.43|2.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.86|-1.43|0.578
73801115|NCT01217112|147150864|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|1.249||0.368|TWO_SIDED|90.0|-0.96|3.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.22|-0.96|0.368
73801116|NCT01217112|147150864|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|1.304||0.696|TWO_SIDED|90.0|-1.67|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.69|-1.67|0.696
73801117|NCT01217112|147150865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.32||0.327|TWO_SIDED|90.0|-0.9|3.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.51|-0.90|0.327
73894251|NCT00669409|147321162|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.5|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-50.3|-6.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.7|-50.3|
73894252|NCT00669409|147321163|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-4.3|29.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.1|-4.3|
73894253|NCT00669409|147321163|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-31.4|1.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.9|-31.4|
73801118|NCT01217112|147150865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|1.303||0.851|TWO_SIDED|90.0|-1.93|2.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.43|-1.93|0.851
73801119|NCT01217112|147150865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.281||0.672|TWO_SIDED|90.0|-1.6|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.69|-1.60|0.672
73801120|NCT01217112|147150865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|1.327||0.978|TWO_SIDED|90.0|-2.26|2.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.18|-2.26|0.978
73801121|NCT01217112|147150866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.512||0.857|TWO_SIDED|90.0|-0.95|0.76|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.76|-0.95|0.857
73801122|NCT01217112|147150866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.549||0.543|TWO_SIDED|90.0|-0.58|1.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.26|-0.58|0.543
73801123|NCT01217112|147150866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.495||0.859|TWO_SIDED|90.0|-0.74|0.92|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.92|-0.74|0.859
73801124|NCT01217112|147150866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.526||0.467|TWO_SIDED|90.0|-1.27|0.5|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.50|-1.27|0.467
73801125|NCT01217112|147150867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.406||0.124|TWO_SIDED|90.0|-1.32|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.05|-1.32|0.124
73801126|NCT01217112|147150867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.439||0.909|TWO_SIDED|90.0|-0.68|0.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.79|-0.68|0.909
73801127|NCT01217112|147150867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.392||0.245|TWO_SIDED|90.0|-1.12|0.2|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.20|-1.12|0.245
73801128|NCT01217112|147150867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.412||0.382|TWO_SIDED|90.0|-1.05|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.33|-1.05|0.382
73801129|NCT01217112|147150868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.837||0.376|TWO_SIDED|90.0|-2.15|0.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.66|-2.15|0.376
73801130|NCT01217112|147150868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.908||0.688|TWO_SIDED|90.0|-1.15|1.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.89|-1.15|0.688
73894254|NCT00669409|147321163|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-14.6|18.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.6|-14.6|
73801131|NCT01217112|147150868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.803||0.637|TWO_SIDED|90.0|-1.73|0.96|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.96|-1.73|0.637
73801132|NCT01217112|147150868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.849||0.355|TWO_SIDED|90.0|-2.22|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.63|-2.22|0.355
73894255|NCT00669409|147321163|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-25.0|7.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.8|-25.0|
73801133|NCT01217112|147150869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.391||0.482|TWO_SIDED|90.0|-0.39|0.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.95|-0.39|0.482
73801134|NCT01217112|147150869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.489||0.708|TWO_SIDED|90.0|-0.65|1.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.02|-0.65|0.708
73801135|NCT01217112|147150869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.434||0.166|TWO_SIDED|90.0|-0.12|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-0.12|0.166
73801136|NCT01217112|147150869|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.408||0.424|TWO_SIDED|90.0|-0.37|1.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.03|-0.37|0.424
73801137|NCT01217112|147150870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.26||0.022|TWO_SIDED|90.0|0.94|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.25|0.94|0.022
73801138|NCT01217112|147150870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|1.532||0.014|TWO_SIDED|90.0|1.44|6.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.69|1.44|0.014
73801139|NCT01217112|147150870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|1.4||0.053|TWO_SIDED|90.0|0.45|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.25|0.45|0.053
73801140|NCT01217112|147150870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|1.299||0.012|TWO_SIDED|90.0|1.33|5.78|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.78|1.33|0.012
73801141|NCT01217112|147150871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.35|STANDARD_ERROR_OF_MEAN|1.463||0.032|TWO_SIDED|90.0|0.84|5.85|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.85|0.84|0.032
73801142|NCT01217112|147150871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.27|STANDARD_ERROR_OF_MEAN|1.798||0.026|TWO_SIDED|90.0|1.18|7.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.35|1.18|0.026
73801143|NCT01217112|147150871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.44|STANDARD_ERROR_OF_MEAN|1.626||0.046|TWO_SIDED|90.0|0.65|6.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.22|0.65|0.046
73801144|NCT01217112|147150871|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|1.512||0.018|TWO_SIDED|90.0|1.26|6.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.45|1.26|0.018
73801145|NCT01217112|147150872|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.806||0.294|TWO_SIDED|90.0|-0.52|2.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.25|-0.52|0.294
73801146|NCT01217112|147150872|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|0.988||0.092|TWO_SIDED|90.0|0.05|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.43|0.05|0.092
73801147|NCT01217112|147150872|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|0.893||0.173|TWO_SIDED|90.0|-0.28|2.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.79|-0.28|0.173
73801148|NCT01217112|147150872|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.837||0.545|TWO_SIDED|90.0|-0.92|1.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.95|-0.92|0.545
73801149|NCT01217112|147150873|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.67|STANDARD_ERROR_OF_MEAN|1.214||0.038|TWO_SIDED|90.0|0.59|4.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.75|0.59|0.038
73801150|NCT01217112|147150873|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|1.486||0.004|TWO_SIDED|90.0|2.16|7.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.26|2.16|0.004
73894256|NCT00669409|147321163|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.1|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-44.9|-1.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-44.9|
73894257|NCT00669409|147321164|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.6|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-5.1|28.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.3|-5.1|
73894258|NCT00669409|147321164|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-32.1|1.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.1|-32.1|
73894259|NCT00669409|147321164|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.5|19.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.7|-13.5|
73894260|NCT00669409|147321164|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.1|9.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.7|-23.1|
73894261|NCT00669409|147321164|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-40.7|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-40.7|
73894262|NCT00669409|147321165|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-4.4|29.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.0|-4.4|
73894263|NCT00669409|147321165|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.2|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-27.8|5.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-27.8|
73894264|NCT00669409|147321165|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.2|20.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.1|-13.2|
73894265|NCT00669409|147321165|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.9|9.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-23.9|
73894266|NCT00669409|147321165|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-40.4|3.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.2|-40.4|
73894267|NCT00669409|147321166|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-5.5|27.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.9|-5.5|
73894268|NCT00669409|147321166|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-26.3|7.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.0|-26.3|
73894269|NCT00669409|147321166|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-14.7|18.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.5|-14.7|
73894270|NCT00669409|147321166|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.6|9.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.2|-23.6|
73894271|NCT00669409|147321166|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-42.2|1.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.4|-42.2|
73894272|NCT00669409|147321167|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|13.5|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-3.2|30.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||30.2|-3.2|
73894273|NCT00669409|147321167|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-23.3|9.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-23.3|
73894274|NCT00669409|147321167|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-11.5|21.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||21.7|-11.5|
73894275|NCT00669409|147321167|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|95.0|-24.1|8.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.8|-24.1|
73894276|NCT00669409|147321167|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-31.6|12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-31.6|
73894277|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-24.7|6.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.4|-24.7|
73894278|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-36.0|-4.9||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.9|-36.0|
73894279|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-19.9|11.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.4|-19.9|
73894280|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-30.9|-0.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.4|-30.9|
73801151|NCT01217112|147150873|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.35||0.088|TWO_SIDED|90.0|0.09|4.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.72|0.09|0.088
73801152|NCT01217112|147150873|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|1.252||0.01|TWO_SIDED|90.0|1.39|5.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.68|1.39|0.010
73801153|NCT01217112|147150874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|1.814||0.064|TWO_SIDED|90.0|0.42|6.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.64|0.42|0.064
73801154|NCT01217112|147150874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.55|STANDARD_ERROR_OF_MEAN|2.237||0.008|TWO_SIDED|90.0|2.72|10.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.38|2.72|0.008
73801155|NCT01217112|147150874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|2.016||0.084|TWO_SIDED|90.0|0.19|7.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.10|0.19|0.084
73801156|NCT01217112|147150874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|1.871||0.041|TWO_SIDED|90.0|0.84|7.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.25|0.84|0.041
73801157|NCT01217112|147150875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.129|TWO_SIDED|90.0|-0.14|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.14|0.129
73801158|NCT01217112|147150875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.051||0.961|TWO_SIDED|90.0|-0.08|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.08|0.961
73801159|NCT01217112|147150875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.048||0.128|TWO_SIDED|90.0|-0.16|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.16|0.128
73801160|NCT01217112|147150875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.045||0.3|TWO_SIDED|90.0|-0.12|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.12|0.300
73801161|NCT01217112|147150876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|5.38||0.625|TWO_SIDED|90.0|-6.37|11.67|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||11.67|-6.37|0.625
73801162|NCT01217112|147150876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.77|STANDARD_ERROR_OF_MEAN|5.519||0.226|TWO_SIDED|90.0|-2.48|16.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||16.02|-2.48|0.226
73801163|NCT01217112|147150876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|5.103||0.904|TWO_SIDED|90.0|-7.94|9.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||9.18|-7.94|0.904
73801164|NCT01217112|147150876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.17|STANDARD_ERROR_OF_MEAN|5.71||0.285|TWO_SIDED|90.0|-3.41|15.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||15.75|-3.41|0.285
73801165|NCT01217112|147150877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.568||0.138|TWO_SIDED|90.0|-1.81|0.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.10|-1.81|0.138
73801166|NCT01217112|147150877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.547||0.505|TWO_SIDED|90.0|-1.28|0.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.55|-1.28|0.505
73801167|NCT01217112|147150877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.54||0.743|TWO_SIDED|90.0|-0.73|1.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.08|-0.73|0.743
73801168|NCT01217112|147150877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.565||0.54|TWO_SIDED|90.0|-0.6|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.29|-0.60|0.540
73801169|NCT01217112|147150879|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|1.664||0.701|TWO_SIDED|90.0|-2.14|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.43|-2.14|0.701
73801170|NCT01217112|147150879|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.77|STANDARD_ERROR_OF_MEAN|1.662||0.006|TWO_SIDED|90.0|1.99|7.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.55|1.99|0.006
73801171|NCT01217112|147150879|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|1.589||0.542|TWO_SIDED|90.0|-1.68|3.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.64|-1.68|0.542
73801172|NCT01217112|147150879|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|1.627||0.827|TWO_SIDED|90.0|-2.36|3.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.08|-2.36|0.827
73801173|NCT03192488|147150880|SUPERIORITY||Mean Difference (Final Values)|1.06||||0.047|TWO_SIDED|95.0|0.01|2.11|||ANOVA|"The overall model was adjusted for the co-variate VO2max."||||2.11|0.01|0.047
73801174|NCT03192488|147150881|SUPERIORITY|||||||0.327|||||||ANOVA|||||||0.327
73801175|NCT03192488|147150881|SUPERIORITY|||||||0.557|||||||ANOVA|||||||0.557
73801176|NCT01366417|147150939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|0.133|<|0.05|TWO_SIDED|95.0|1.95|2.48|||ANOVA|||Hypothesis: ChloraPrep will meet or exceed the 1.0 log reduction in colony forming units/cm\^2 at 30 seconds after application.||2.48|1.95|< 0.05
73801177|NCT01366417|147150939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.25|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|1.99|2.51|||ANOVA|||hypothesis: 70% Isopropyl Alcohol will meet or exceed 1.0 log 10 colony forming units / cm\^2 at 30 seconds after treatment||2.51|1.99|<0.05
73801178|NCT01366417|147150940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.65|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|2.39|2.91|||ANOVA|||Hypothesis: ChloraPrep One Step will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment.||2.91|2.39|<0.05
73801179|NCT01366417|147150940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.6|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|2.33|2.86|||ANOVA|||Hypothesis: 70% Isopropyl Alcohol will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment||2.86|2.33|<0.05
73894281|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.1|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-49.4|-8.9||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-8.9|-49.4|
73894282|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-16.9|14.3||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.3|-16.9|
73801180|NCT01641640|147150970|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial exact test|||Superiority would be demonstrated if the SVR12 rate was higher than the 60% null SVR rate based on historical control data.||||< 0.001
73801181|NCT01234350|147150979|OTHER||IRR|0.829||||0.4007|TWO_SIDED|95.0|0.536|1.283||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% confidence interval (CI), and incidence rate ratio (IRRs) with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|The IRs were estimated using a Poisson-mixture regression model.||1.283|0.536|0.4007
73801182|NCT01234350|147150980|OTHER||IRR|0.874||||0.671|TWO_SIDED|95.0|0.47|1.626||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For osteoporosis and osteopenia events. The IRs were estimated using Poisson-mixture regression model.||1.626|0.470|0.6710
73801183|NCT01234350|147150980|OTHER||IRR|1.857||||0.4544|TWO_SIDED|95.0|0.367|9.403||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For bone fracture events. The IRs were estimated using Poisson-mixture regression model.||9.403|0.367|0.4544
73894283|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-29.5|1.7||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.7|-29.5|
73894284|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-15.4|16.5||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-15.4|
73894285|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-27.3|3.7||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.7|-27.3|
73894286|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-43.1|-2.4||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.4|-43.1|
73894287|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-33.2|-0.3||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.3|-33.2|
73894288|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-43.7|-10.8||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-10.8|-43.7|
73894289|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-23.4|9.9||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-23.4|
73894290|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.4|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-35.6|-3.2||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.2|-35.6|
73894291|NCT00669409|147321168|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.4|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-45.8|-2.9||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-45.8|
73894292|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-18.5|12.6||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.6|-18.5|
73894293|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.7|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-30.3|0.8||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.8|-30.3|
73894294|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-3.2|28.1||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.1|-3.2|
73894295|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-23.1|7.4||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.4|-23.1|
73801184|NCT01234350|147150981|OTHER||IRR|1.193||||0.2529|TWO_SIDED|95.0|0.882|1.613||Poisson mixture regression was used to model the influence of age, stage of disease, and history of diabetes mellitus along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For glucose intolerance. The IRs were estimated using Poisson-mixture regression model.||1.613|0.882|0.2529
73894296|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-23.3|17.2||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.2|-23.3|
73894297|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-14.9|16.3||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.3|-14.9|
73894298|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-25.5|5.7||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.7|-25.5|
73894299|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-3.4|28.5||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.5|-3.4|
73894300|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-21.9|9.0||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-21.9|
73894301|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-25.2|15.5||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.5|-25.2|
73894302|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-21.4|11.5||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.5|-21.4|
73894303|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-30.3|2.7||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.7|-30.3|
73894304|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|16.1|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-0.6|32.7||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||32.7|-0.6|
73894305|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-22.9|9.5||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.5|-22.9|
73894306|NCT00669409|147321169|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-25.5|17.4||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.4|-25.5|
73894307|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-22.9|8.2||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.2|-22.9|
73894308|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-34.4|-3.3||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-34.4|
73894309|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-25.2|6.1||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.1|-25.2|
73894310|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-30.8|-0.2||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.2|-30.8|
73894311|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.9|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-48.1|-7.6||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.6|-48.1|
73894312|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-21.3|9.9||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-21.3|
73894313|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-32.6|-1.4||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.4|-32.6|
73894314|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-24.3|7.5||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.5|-24.3|
73894315|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.8|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-32.2|-1.3||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-32.2|
73801185|NCT01234350|147150981|OTHER||IRR|2.623||||0.0208|TWO_SIDED|95.0|1.158|5.944||Poisson-mixture regression is used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual trial exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For T2DM. The IRs were estimated using Poisson-mixture regression model.||5.944|1.158|0.0208
73801186|NCT01234350|147150988|OTHER||Odds Ratio (OR)|0.747||||0.0821|TWO_SIDED|95.0|0.537|1.038||A logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group on the time to event for all-cause mortality.|Regression, Logistic|Logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group.||The analyses of all-cause mortality was based on logistic regressions.||1.038|0.537|0.0821
73801187|NCT01839708|147150989|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73801188|NCT01839708|147150990|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73801189|NCT01839708|147150991|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73801190|NCT01839708|147150992|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73801191|NCT01839708|147150993|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73801192|NCT01839708|147150994|OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
73801193|NCT01839708|147150995|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73801194|NCT01839708|147150996|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73801195|NCT01839708|147150997|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73801196|NCT01839708|147150998|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73894316|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.5|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-47.8|-7.1||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.1|-47.8|
73894317|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-25.5|7.4||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.4|-25.5|
73894318|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-36.1|-3.2||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.2|-36.1|
73894319|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-22.1|11.3||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.3|-22.1|
73801197|NCT01839708|147150999|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73801198|NCT01839708|147151000|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73801199|NCT01839708|147151001|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73801200|NCT01839708|147151002|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73801201|NCT01051960|147151008|OTHER|comparison of means|Mean Difference (Final Values)|-93.0||||0.0008|TWO_SIDED|||||significant at p\<0.05|t-test, 2 sided|||Whether change from baseline to 24-weeks is significantly different from zero||||.0008
73801202|NCT01051960|147151009|OTHER||Mean Difference (Final Values)|44.5||||7e-05|TWO_SIDED||||||t-test, 2 sided|||change from baseline to 24 weeks||||0.00007
73801203|NCT02069015|147151032|SUPERIORITY||Mean Difference|0.05|||<|0.001|TWO_SIDED|95.0|-4.781|6.906|||paired t-test|||||6.906|-4.781|<0.001
73801204|NCT03051100|147151054|SUPERIORITY||Least squares mean difference|-60.5|STANDARD_ERROR_OF_MEAN|3.67|<|0.001|TWO_SIDED|95.0|-68.0|-53.0|||ANCOVA||Triplet therapy minus placebo|||-53.0|-68.0|<0.001
73801205|NCT03051100|147151055|SUPERIORITY||Least squares mean difference|-58.7|STANDARD_ERROR_OF_MEAN|3.02|<|0.001|TWO_SIDED|95.0|-64.9|-52.6|||ANCOVA||Triplet therapy minus placebo|non-HDL-C||-52.6|-64.9|<0.001
73801206|NCT03051100|147151055|SUPERIORITY||Least squares mean difference|-46.0|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-51.6|-40.4|||ANCOVA||Triplet therapy minus placebo|TC||-40.4|-51.6|<0.001
73801207|NCT03051100|147151055|SUPERIORITY||Least squares mean difference|-54.1|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-59.7|-48.6|||ANCOVA|||apoB||-48.6|-59.7|<0.001
73801208|NCT03051100|147151055|SUPERIORITY||Least squares mean difference|-36.3|STANDARD_ERROR_OF_MEAN|6.58|<|0.001|TWO_SIDED|95.0|-49.7|-22.8|||ANCOVA|||TG||-22.8|-49.7|<0.001
73801209|NCT03051100|147151055|SUPERIORITY||Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|2.7|=|0.588|TWO_SIDED|95.0|-7.0|4.0|||ANCOVA|||HDL-C||4.0|-7.0|=0.588
73801210|NCT03051100|147151056|SUPERIORITY||Median treatment difference|-41.9|STANDARD_ERROR_OF_MEAN|9.86|<|0.001|TWO_SIDED|95.0|-60.0|-21.4|||Wilcoxon rank sum test|||||-21.4|-60.0|<0.001
73801211|NCT03051100|147151057|SUPERIORITY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73801212|NCT03051100|147151058|SUPERIORITY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73801213|NCT01169064|147151062|SUPERIORITY_OR_OTHER|||||||0.365|||||||Chi-squared|||||||.365
73801214|NCT01169064|147151063|SUPERIORITY|||||||0.282|||||||Mixed Models Analysis|||||||.282
73801215|NCT00789854|147151065|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha\* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-2.322||||||97.5|-4.6|-0.05||The CI is for comparing add-on quetiapine versus add-on Lithium. The CI = confidence interval was adjusted for multiple comparisons. The -0.05 value should have been +3 or above to fail to reject the null hypothesis.|ANCOVA|Non-inferiority between add-on quetiapine XR and add-on lithium was shown in the Per Protocol analysis set.||Add-on quetiapine XR was tested versus add-on lithium for non-inferiority. The null hypothesis was that the add-on quetiapine treatment was non-inferior to add-on lithium.||-0.05|-4.6|
73801216|NCT00789854|147151065|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha\* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-1.639||||||97.5|-3.24|1.312||The CI is for comparing quetiapine XR mono versus add-on Lithium. The CI = confidence interval was adjusted for multiple comparisons. The 1.312 value should have been +3 or above to fail to reject the null hypothesis.|ANCOVA|Non-inferiority between quetiapine XR mono and add-on lithium was shown in the Per Protocol analysis set.||Quetiapine XR mono was tested versus add-on lithium for non-inferiority. The null hypothesis was that the quetiapine XR mono treatment was non-inferior to add-on lithium.||1.312|-3.24|
73801217|NCT00789854|147151066|SUPERIORITY_OR_OTHER|||||||0.0489||95.0||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the add-on quetiapine XR treatment was not different to the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.||||0.0489
73801218|NCT00789854|147151066|SUPERIORITY_OR_OTHER|||||||0.4368||95.0||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the quetiapine XR mono treatment was not different from the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.||||0.4368
73801219|NCT02224157|147151107|NON_INFERIORITY|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Upper limit of the 1-sided 95% confidence limit \<1.2 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid|Rate ratio|0.97|||||ONE_SIDED|95.0||1.16|||Negative binomial model|Adjusted for randomised treatment, pre-study treatment and region. Logarithm of follow-up time is used as an offset variable.|A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.|||1.16||
73801220|NCT02224157|147151108|SUPERIORITY||Hazard Ratio (HR)|0.955||||0.664|TWO_SIDED|95.0|0.777|1.174|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||1.174|0.777|0.664
73801221|NCT02224157|147151109|SUPERIORITY||Least Square Mean Difference|-32.6||||0.003|TWO_SIDED|95.0|-53.7|-11.4|||Mixed Models Analysis|Rand treatment,pre-study treatment,region,visit,rand treatment by visit; fixed effects. Patient; random effect, baseline FEV1; covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. Estimate corresponds to average treatment effect across all treatment visits.|||-11.4|-53.7|0.003
73894320|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.7|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-30.9|1.6||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-30.9|
73801222|NCT02224157|147151111|SUPERIORITY||Least Square Mean Difference|0.03|||||TWO_SIDED|95.0|0.0|0.07||No p-value was calculated for this efficacy variable|ANCOVA|Model with randomised treatment, pre-study treatment and region as factors, and no. of 'as needed' inhalations at baseline as continuous covariate|A mean difference less than zero indicates a larger mean reduction in number of 'as needed' inhalations in the Symbicort 'as needed' group.|||0.07|0.00|
73801223|NCT02224157|147151112|SUPERIORITY||Least Square Mean Difference|-6.85|||<|0.001|TWO_SIDED|95.0|-8.37|-5.34|||ANCOVA|adjusted for randomised treatment, pre-study treatment and region as factors and the percent 'as needed' free days during run-in as a cont covariate.|An estimate of difference \>0 means that there was a larger increase in the % of 'as needed' free days in the Symbicort 'as-needed' arm.|||-5.34|-8.37|< 0.001
73801224|NCT02224157|147151113|SUPERIORITY||Least Square Mean Difference|-37.48|||<|0.001|TWO_SIDED|95.0|-39.18|-35.77|||ANOVA|model adjusted for: randomised treatment, pre-study treatment and region.|An estimate of difference \>0 means that there was a higher % of controller use days in the Symbicort 'as-needed' group.|||-35.77|-39.18|<0.001
73801225|NCT02224157|147151114|SUPERIORITY||Least Square Mean Difference|0.109|||<|0.001|TWO_SIDED|95.0|0.068|0.15|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random, and baseline ACQ-5 as covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||0.150|0.068|<0.001
73801226|NCT02224157|147151115|SUPERIORITY||Least Square Mean Difference|-0.096|||<|0.001|TWO_SIDED|95.0|-0.137|-0.054|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random and baseline AQLQ as covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-0.054|-0.137|<0.001
73801227|NCT02224157|147151116|SUPERIORITY||Rate ratio|0.97||||0.754|TWO_SIDED|95.0|0.78|1.2|||Negative binomial model|Adjusted for randomised treatment, pre-study treatment and region. Logarithm of follow-up time is used as an offset variable.|A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.|||1.20|0.78|0.754
73801228|NCT05906628|147151144|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|4.48|21.49|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||||21.49|4.48|<0.0001
73801229|NCT05906628|147151144|SUPERIORITY||Response rate difference|42.5|STANDARD_ERROR_OF_MEAN|6.03|||TWO_SIDED|95.0|30.7|54.36||||||||54.36|30.70|
73801230|NCT05906628|147151145|SUPERIORITY||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.14|8.38|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 4||8.38|2.14|<0.0001
73801231|NCT05906628|147151145|SUPERIORITY||Response rate difference|29.5|STANDARD_ERROR_OF_MEAN|6.52|||TWO_SIDED|95.0|16.69|42.24||||||Week 4||42.24|16.69|
73801232|NCT05906628|147151145|SUPERIORITY||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.02|7.51|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 16||7.51|2.02|<0.0001
73801233|NCT05906628|147151145|SUPERIORITY||Response rate difference|29.5|STANDARD_ERROR_OF_MEAN|6.69|||TWO_SIDED|95.0|16.34|42.57||||||Week 16||42.57|16.34|
73801234|NCT05906628|147151146|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1789|TWO_SIDED|95.0|0.718|5.923|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Day 3||5.923|0.718|0.1789
73801235|NCT05906628|147151146|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0024|TWO_SIDED|95.0|1.603|8.951|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 1 (Day 7)||8.951|1.603|0.0024
73801236|NCT05906628|147151147|SUPERIORITY||Odds Ratio (OR)|9.91|||<|0.0001|TWO_SIDED|95.0|4.44|22.13|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 16||22.13|4.44|<0.0001
73801237|NCT05906628|147151147|SUPERIORITY||Response rate difference|45.6|STANDARD_ERROR_OF_MEAN|6.49|||TWO_SIDED|95.0|32.83|58.27||||||Week 16||58.27|32.83|
73801238|NCT05906628|147151149|SUPERIORITY||Cox regression model|1.719||||0.0025|TWO_SIDED|95.0|1.211|2.44|||Log Rank|stratified by randomization stratification factors|Cox regression model stratified by stratification factors (Baseline IGA-CHE 3/4, Region : North America or outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||2.440|1.211|0.0025
73801239|NCT05906628|147151152|SUPERIORITY||Cox regression model|1.279||||0.1319|TWO_SIDED|95.0|0.931|1.759|||Log Rank|stratified by randomization stratification factors|Cox regression model stratified by stratification factors (Baseline IGA-CHE 3/4, Region : North America or outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||1.759|0.931|0.1319
73801240|NCT01416636|147151181|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
73801241|NCT01416636|147151181|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
73801242|NCT01416636|147151182|SUPERIORITY|||||||0.605|||||||Wilcoxon (Mann-Whitney)|||||||0.605
73801243|NCT01416636|147151183|SUPERIORITY|||||||0.307|||||||Wilcoxon (Mann-Whitney)|||||||0.307
73801244|NCT01416636|147151184|SUPERIORITY|||||||0.0019|||||||Chi-squared|||||||0.0019
73801245|NCT01416636|147151185|SUPERIORITY|||||||0.557|||||||Wilcoxon (Mann-Whitney)|||||||0.557
73801246|NCT01416636|147151186|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
73801247|NCT01416636|147151187|SUPERIORITY|||||||1e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00001
73801248|NCT01416636|147151188|SUPERIORITY|||||||3e-06|||||||Wilcoxon (Mann-Whitney)|||||||0.000003
73801249|NCT01416636|147151189|SUPERIORITY|||||||8e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00008
73801250|NCT01416636|147151190|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
73801251|NCT01416636|147151191|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
73801252|NCT02301169|147151193|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Average Pain Score (APS), T4P1001 compared with placebo|Mean Difference (Final Values)|0.3748299||||0.4162|TWO_SIDED|95.0|-0.5479411|1.297601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons|t-test, 2 sided|Welch two sample t-test||||1.2976010|-0.5479411|0.4162
73894321|NCT00669409|147321170|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-44.4|-1.5||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.5|-44.4|
73894322|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-12.2|18.8||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.8|-12.2|
73894323|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-27.0|4.1||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.1|-27.0|
73894324|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-17.4|13.9||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.9|-17.4|
73894325|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-24.8|5.8||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.8|-24.8|
73894326|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-39.2|1.3||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.3|-39.2|
73894327|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-10.6|20.6||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.6|-10.6|
73894328|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-24.0|7.1||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.1|-24.0|
73894329|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-17.1|14.8||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.8|-17.1|
73894330|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-24.6|6.3||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.3|-24.6|
73894331|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-38.2|2.5||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.5|-38.2|
73894332|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-18.3|14.6||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.6|-18.3|
73894333|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.1|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-36.5|-3.6||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.6|-36.5|
73894334|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-19.5|13.9||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.9|-19.5|
73894335|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-27.1|5.4||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-27.1|
73894336|NCT00669409|147321171|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-32.0|10.9||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-32.0|
73894337|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|13.0|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-2.5|28.6||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.6|-2.5|
73894338|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-21.0|10.0||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.0|-21.0|
73894339|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-10.4|20.9||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.9|-10.4|
73894340|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-23.1|7.5||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.5|-23.1|
73894341|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-29.7|10.8||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.8|-29.7|
73894342|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|14.3|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-1.3|29.8||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.8|-1.3|
73801253|NCT02301169|147151194|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Worst Pain Score (WPS), T4P1001 compared with placebo.|Mean Difference (Final Values)|0.1255102||||0.7887|TWO_SIDED|95.0|-0.8152493|1.0662697||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||1.0662697|-0.8152493|0.7887
73801254|NCT02301169|147151195|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by Investigator Global Assessment of Change, T4P1001 compared with Placebo|Mean Difference (Final Values)|0.802381||||0.2353|TWO_SIDED|95.0|-0.5457743|2.1505362||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||2.1505362|-0.5457743|0.2353
73801255|NCT02301169|147151196|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain intensity measured after heat pain stimuli, T4P1001 compared with placebo.|Mean Difference (Final Values)|0.7656429||||0.06204|TWO_SIDED|95.0|-0.0406744|1.5719601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||1.5719601|-0.0406744|0.06204
73801256|NCT02301169|147151197|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by the Brief Pain Inventory (BPI), T4P1001 compared with placebo.|Mean Difference (Final Values)|1.683333||||0.3386|TWO_SIDED|95.0|-1.83119|5.197857||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||5.197857|-1.831190|0.3386
73801257|NCT00380874|147151200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.2536||||||Cycle 1. No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.2536
73801258|NCT00380874|147151200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.23||0.5757||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.5757
73801259|NCT00380874|147151200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6065||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.6065
73801260|NCT00380874|147151200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.31||0.4301||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.4301
73801261|NCT00380874|147151200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.49||0.3125||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.3125
73801262|NCT00380874|147151200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.41||0.8169||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.8169
73894343|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-19.2|12.0||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-19.2|
73894344|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-9.1|22.8||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||22.8|-9.1|
73894345|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-25.8|5.1||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.1|-25.8|
73894346|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-28.8|12.0||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-28.8|
73801263|NCT00380874|147151200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.4||0.9359|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 7. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.9359
73801264|NCT00380874|147151200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6233|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.6233
73801265|NCT00380874|147151200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.5||0.1569||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.1569
73801266|NCT00380874|147151201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7207||95.0|-0.25|0.17||Model terms include treatment, study center, and baseline score.|ANCOVA|Cycle 1. No multiple comparisons adjustment was made.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1.||0.17|-0.25|0.7207
73801267|NCT00380874|147151201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.36||0.3111||95.0|-0.36|1.1||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2.||1.10|-0.36|0.3111
73801268|NCT00380874|147151201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.48||0.5925||95.0|-0.7|1.22||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3.||1.22|-0.70|0.5925
73801269|NCT00380874|147151201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.55||0.5812||95.0|-0.8|1.41||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4.||1.41|-0.80|0.5812
73801270|NCT00380874|147151201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.7||0.2925||95.0|-0.67|2.16||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5.||2.16|-0.67|0.2925
73801271|NCT00380874|147151201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.54||0.9276||95.0|-1.15|1.05||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.||1.05|-1.15|0.9276
73801272|NCT00380874|147151201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.53||0.9952||95.0|-1.06|1.07|||ANCOVA|Model terms include treatment, study center, and baseline score.||Cycle 7.||1.07|-1.06|0.9952
73801273|NCT00380874|147151201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.55||0.6265||95.0|-0.85|1.38|||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8.||1.38|-0.85|0.6265
73801274|NCT00380874|147151201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.62||0.4209||95.0|-1.77|0.76||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.||0.76|-1.77|0.4209
73894347|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-9.5|23.4||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||23.4|-9.5|
73894348|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-22.4|10.6||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.6|-22.4|
73801275|NCT00380874|147151201|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.54||0.9657||95.0|-1.06|1.11||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Last Observation Carried Forward (LOCF)endpoint.||1.11|-1.06|0.9657
73801276|NCT00380874|147151202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.5392||95.0|-0.24|0.12|||ANCOVA|||Cycle 1.||0.12|-0.24|0.5392
73801277|NCT00380874|147151202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.22||0.5412||95.0|-0.3|0.57|||ANCOVA|||Cycle 2.||0.57|-0.30|0.5412
73801278|NCT00380874|147151202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.34||0.5358||95.0|-0.48|0.9|||ANCOVA|||Cycle 3.||0.90|-0.48|0.5358
73801279|NCT00380874|147151202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.41||0.4059||95.0|-0.48|1.17|||ANCOVA|||Cycle 4.||1.17|-0.48|0.4059
73801280|NCT00380874|147151202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.49||0.2712||95.0|-0.44|1.52|||ANCOVA|||Cycle 5.||1.52|-0.44|0.2712
73801281|NCT00380874|147151202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.38||0.9181||95.0|-0.81|0.73|||ANCOVA|||Cycle 6.||0.73|-0.81|0.9181
73801282|NCT00380874|147151202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.42||0.4357||95.0|-0.52|1.17|||ANCOVA|||Cycle 7.||1.17|-0.52|0.4357
73801283|NCT00380874|147151202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.49||0.5103||95.0|-0.67|1.33|||ANCOVA|||||1.33|-0.67|0.5103
73801284|NCT00380874|147151202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.58||0.8499||95.0|-1.29|1.07|||ANCOVA|||Cycle 9.||1.07|-1.29|0.8499
73801285|NCT00380874|147151202|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.39||0.7359||95.0|-0.9|0.64|||ANCOVA|||LOCF endpoint.||0.64|-0.90|0.7359
73801286|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.09||0.2034||95.0|-0.06|0.29|||ANCOVA|||Burning Spontaneous Pain Cycle 3||0.29|-0.06|0.2034
73801287|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.3062||95.0|-0.4|0.13|||ANCOVA|||Burning Spontaneous Pain Cycle 4||0.13|-0.40|0.3062
73801288|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.2787||95.0|-0.37|0.11|||ANCOVA|||Burning Spontaneous Pain Cycle 5||0.11|-0.37|0.2787
73801289|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.4124||95.0|-0.2|0.47|||ANCOVA|||Burning Spontaneous Pain Cycle 6||0.47|-0.20|0.4124
73801290|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.35||0.9541||95.0|-0.68|0.73|||ANCOVA|||Burning Spontaneous Pain Cycle 7||0.73|-0.68|0.9541
73801291|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3383||95.0|-0.33|0.92|||ANOVA|||Burning Spontaneous Pain Cycle 8||0.92|-0.33|0.3383
73801292|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.8918||95.0|-0.84|0.74|||ANCOVA|||Burning Spontaneous Pain||0.74|-0.84|0.8918
73801293|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.26||0.9614||95.0|-0.54|0.51|||ANCOVA|||Burning Spontaneous Pain LOCF endpoint||0.51|-0.54|0.9614
73801294|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3022||95.0|-0.17|0.05|||ANCOVA|||Pressing Spontaneous Pain Cycle 2||0.05|-0.17|0.3022
73801295|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3747||95.0|-0.04|0.12|||ANCOVA|||Pressing Spontaneous Pain Cycle 3||0.12|-0.04|0.3747
73801296|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.163||95.0|-0.4|0.07|||ANCOVA|||Pressing Spontaneous Pain Cycle 4||0.07|-0.40|0.1630
73801297|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9568||95.0|-0.12|0.11|||ANOVA|||Pressing Spontaneous Pain Cycle 5||0.11|-0.12|0.9568
73801298|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9793||95.0|-0.13|0.13|||ANCOVA|||Pressing Spontaneous Pain Cycle 6||0.13|-0.13|0.9793
73801299|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.25||0.885||95.0|-0.54|0.47|||ANCOVA|||Pressing Spontaneous Pain Cycle 7||0.47|-0.54|0.8850
73801300|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2199||95.0|-0.17|0.7|||ANCOVA|||Pressing Spontaneous Pain Cycle 8||0.70|-0.17|0.2199
73801301|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.4017||95.0|-0.14|0.35|||ANCOVA|||Pressing Spontaneous Pain Cycle 9||0.35|-0.14|0.4017
73801302|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4113||95.0|-0.1|0.24|||ANCOVA|||Pressing Spontaneous Pain LOCF Endpoint||0.24|-0.10|0.4113
73801303|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3011||95.0|-0.06|0.02|||ANCOVA|||Paroxysmal Pain Cycle 3||0.02|-0.06|0.3011
73801304|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.4482||95.0|-0.26|0.12|||ANCOVA|||Paroxysmal Pain Cycle 4||0.12|-0.26|0.4482
73801305|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.3058||95.0|-0.31|0.1|||ANCOVA|||Paroxysmal Pain Cycle 5||0.10|-0.31|0.3058
73801306|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.3035||95.0|-0.38|0.12|||ANCOVA|||Paroxysmal Pain Cycle 6||0.12|-0.38|0.3035
73801307|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.23||0.9636||95.0|-0.46|0.48|||ANCOVA|||Paroxysmal Pain Cycle 7||0.48|-0.46|0.9636
73801308|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.35||0.366||95.0|-0.38|1.02|||ANCOVA|||Paroxysmal Pain Cycle 8||1.02|-0.38|0.3660
73801309|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.4093||95.0|-0.69|0.29|||ANCOVA|||Paroxysmal Pain Cycle 9||0.29|-0.69|0.4093
73801310|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5208||95.0|-0.39|0.2|||ANCOVA|||Paroxysmal Pain LOCF Endpoint||0.20|-0.39|0.5208
73801311|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9931||95.0|-0.17|0.17|||ANCOVA|||Evoke Pain Cycle 2||0.17|-0.17|0.9931
73801312|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.5867||95.0|-0.25|0.44|||ANCOVA|||Evoke Pain Cycle 3||0.44|-0.25|0.5867
73801313|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.2748||95.0|-0.37|0.11|||ANCOVA|||Evoke Pain Cycle 4||0.11|-0.37|0.2748
73801314|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.5521||95.0|-0.51|0.28|||ANCOVA|||Evoke Pain Cycle 5||0.28|-0.51|0.5521
73801315|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.39||0.6734||95.0|-0.96|0.62|||ANCOVA|||Evoke Pain Cycle 6||0.62|-0.96|0.6734
73801316|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.37||0.1214||95.0|-0.16|1.33|||ANCOVA|||Evoke Pain Cycle 7||1.33|-0.16|0.1214
73894349|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.2|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-4.5|28.9||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.9|-4.5|
73894350|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-25.2|7.2||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.2|-25.2|
73801317|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.51||0.1845||95.0|-0.34|1.72|||ANCOVA|||Evoke Pain Cycle 8||1.72|-0.34|0.1845
73801318|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.37||0.6863||95.0|-0.6|0.9|||ANCOVA|||Evoke Pain Cycle 9||0.90|-0.60|0.6863
73801319|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.27||0.9273||95.0|-0.51|0.56|||ANCOVA|||Evoke Pain LOCF Endpoint||0.56|-0.51|0.9273
73801320|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.12||0.0416||95.0|0.01|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 2||0.50|0.01|0.0416
73801321|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1819||95.0|-0.1|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 3||0.50|-0.10|0.1819
73894351|NCT00669409|147321172|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-22.4|20.5||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.5|-22.4|
73801322|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.17||0.0331||95.0|0.03|0.7|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 4||0.70|0.03|0.0331
73801323|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0608||95.0|-0.02|0.83|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 5||0.83|-0.02|0.0608
73801324|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.33||0.2809||95.0|-0.31|1.03|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 6||1.03|-0.31|0.2809
73801325|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.32||0.3445||95.0|-0.34|0.95|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 7||0.95|-0.34|0.3445
73801326|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.47||0.2806||95.0|-0.44|1.46|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 8||1.46|-0.44|0.2806
73801327|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.49||0.5217||95.0|-0.68|1.33|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 9||1.33|-0.68|0.5217
73801328|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.34||0.3628||95.0|-0.37|1.0|||ANCOVA|||Parethesia/Dysesthesia Pain LOCF Endpoint||1.00|-0.37|0.3628
73801329|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.3557||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 2||0.01|-0.00|0.3557
73801330|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.2824||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 3||0.01|-0.00|0.2824
73801331|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5931||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 4||0.01|-0.01|0.5931
73801332|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.9865||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 5||0.01|-0.01|0.9865
73801333|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9854||95.0|-0.02|0.02|||ANCOVA|||Total Score Cycle 6||0.02|-0.02|0.9854
73801334|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3403||95.0|-0.01|0.04|||ANCOVA|||Total Score Cycle 7||0.04|-0.01|0.3403
73801335|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.2226||95.0|-0.01|0.05|||ANCOVA|||Total Score Cycle 8||0.05|-0.01|0.2226
73801336|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9694||95.0|-0.03|0.03|||ANCOVA|||Total Score Cycle 9||0.03|-0.03|0.9694
73801337|NCT00380874|147151203|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.8957||95.0|-0.02|0.02|||ANCOVA|||Total Score LOCF Endpoint||0.02|-0.02|0.8957
73801338|NCT00380874|147151205|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.49||0.7489||95.0||||No multiple comparisons adjustment was necessary.|ANCOVA|Model terms include treatment, study center, and baseline score.|Least squares (LS) means and corresponding standard errors derived from ANCOVA model were used.|LOCF cycle endpoint. Sample size based on original primary efficacy parameter (PEP) of time to persistent symptoms (developing in 35% of pregabalin subjects \& 60% of placebo subjects). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, study would have had at least 90% power using 100 subjects per treatment group. Original PEP was modified to secondary due to lack of persistent paresthetic symptom emergence.||||0.7489
73801339|NCT02949973|147151219|OTHER||Percentage|70.0|||||TWO_SIDED|||||||||||||
73801340|NCT02949973|147151220|OTHER||Percentage|40.0|||||TWO_SIDED|||||||||||||
73801341|NCT02949973|147151221|OTHER||Percentage|20.0|||||TWO_SIDED|||||||||||||
73801342|NCT02949973|147151222|OTHER||Percentage|20.0|||||TWO_SIDED|||||||||||||
73801343|NCT02949973|147151223|OTHER||Percentage|70.0|||||TWO_SIDED|95.0|34.8|93.3||||||||93.3|34.8|
73801344|NCT02949973|147151224|OTHER||Percentage|50.0|||||TWO_SIDED|95.0|15.7|84.3||||||||84.3|15.7|
73801345|NCT02857816|147151225|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||This is a single arm study. The primary objective was to demonstrate a statistically significant reduction between baseline and following the 12th PTNM therapy sessions in the number of UUI episodes per day.||||<0.0001
73801346|NCT01597778|147151252|SUPERIORITY||Difference in Kaplan-Meier estimates|6.1||||0.4092|TWO_SIDED|95.0|-5.2|17.4||Statistical significance was determined using a pre-specified threshold of 0.05. Final p-value is adjusted for the interim looks per study design.|Z-test to compare the Kaplan-Meier Est.|||The primary null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM.||17.4|-5.2|0.4092
73801347|NCT01597778|147151252|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.06|TWO_SIDED|95.0|0.99|1.7||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||The null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM after adjustment for age, performance score, and disease type.||1.70|0.99|0.060
73801348|NCT01597778|147151254|SUPERIORITY|||||||0.046||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before neutrophil recovery is competing risk.||The null hypothesis is that there is no difference between the neutrophil engraftment post-transplantation for dUCB vs. haplo-BM.||||0.046
73801349|NCT01597778|147151255|SUPERIORITY|||||||0.16||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before Platelet recovery is competing risk.||The null hypothesis is that there is no difference between the platelet engraftment to 20k post-transplantation for dUCB vs. haplo-BM.||||0.160
73801350|NCT01597778|147151255|SUPERIORITY|||||||0.146||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before Platelet recovery is competing risk.||The null hypothesis is that there is no difference between the platelet engraftment to 50k post-transplantation for dUCB vs. haplo-BM.||||0.146
73801351|NCT01597778|147151257|SUPERIORITY|||||||0.693||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before 2nd graft failure is competing risk.||The null hypothesis is that there is no difference between the secondary graft failure probabilities post-transplantation for dUCB vs. haplo-BM.||||0.693
73801352|NCT01597778|147151258|SUPERIORITY|||||||0.142||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to aGVHD is competing risk.||The null hypothesis is that there is no difference between the aGVHD grade II - IV probabilities post-transplantation for dUCB vs. haplo-BM.||||0.142
73801353|NCT01597778|147151258|SUPERIORITY|||||||0.604||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to aGVHD is competing risk.||The null hypothesis is that there is no difference between the aGVHD grade III - IV probabilities post-transplantation for dUCB vs. haplo-BM.||||0.604
73801354|NCT01597778|147151259|SUPERIORITY|||||||0.361||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before cGVHD is competing risk.||The null hypothesis is that there is no difference between the cGVHD probabilities post-transplantation for dUCB vs. haplo-BM.||||0.361
73801355|NCT01597778|147151260|SUPERIORITY|||||||0.0373||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference between the OS probabilities at year 2 post-randomization for dUCB vs. haplo-BM.||||0.0373
73801356|NCT01597778|147151260|SUPERIORITY|||||||0.0235||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference between the OS probabilities at year 2 post-transplant for dUCB vs. haplo-BM.||||0.0235
73801357|NCT01597778|147151261|SUPERIORITY|||||||0.039||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality across the two treatment groups.||The null hypothesis is that there is no difference between the TRM probabilities post-randomization for dUCB vs. haplo-BM.||||0.039
73801358|NCT01597778|147151261|SUPERIORITY|||||||0.03||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality across the two treatment groups.||The null hypothesis is that there is no difference between the TRM probabilities post-transplantation for dUCB vs. haplo-BM||||0.030
73801359|NCT01597778|147151262|SUPERIORITY|||||||0.968||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to relapse is competing risk.||The null hypothesis is that there is no difference between the relapse/progression probabilities post-randomization for dUCB vs. haplo-BM.||||0.968
73801360|NCT01597778|147151262|SUPERIORITY|||||||0.907||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to relapse is competing risk.||The null hypothesis is that there is no difference between the relapse/progression probabilities post- transplantation for dUCB vs. haplo-BM.||||0.907
73801361|NCT01597778|147151265|SUPERIORITY|||||||0.0003||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference between the total duration of hospitalization within 6 months post-randomization for dUCB vs. haplo-BM.||||0.0003
73801362|NCT01451463|147151351|SUPERIORITY_OR_OTHER|||||||0.009|||||||t-test, 2 sided|||||||.009
73801363|NCT01451463|147151352|SUPERIORITY_OR_OTHER|||||||0.114|||||||t-test, 2 sided|||||||.114
73801364|NCT02723344|147151361|OTHER|||||||0.056|||||||Wilcoxon-rank sum|||||||.056
73801365|NCT02723344|147151362|OTHER|||||||0.26||||||Wilcoxon Rank-Sum|Wilcoxon (Mann-Whitney)|||||||.26
73801366|NCT02723344|147151364|OTHER|||||||0.64|||||||Wilcoxon Rank-Sum|||||||.64
73801367|NCT03473184|147151371|OTHER|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||1|||||||ANOVA|||Irradiated vehicle and untreated irradiated sites versus irradiated diacerein site, and non-irradiated vehicle site versus non-irradiated diacerein site and untreated irradiated site versus irradiated vehicle site.||||1.0000
73801368|NCT03473184|147151371|OTHER|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||0.0008|||||||ANOVA|||Non-irradiated diacerein and vehicle sites versus irradiated diacerein site, and irradiated vehicle and untreated irradiated sites versus non-irradiated diacerein site, and non-irradiated vehicle site versus irradiated vehicle site, and untreated irradiated site versus non-irradiated vehicle site.||||0.0008
73801369|NCT02964247|147151381|SUPERIORITY||Treatment difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.89|-0.48|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in HbA1c from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate.||-0.48|-0.89|<.001
73801370|NCT02964247|147151381|SUPERIORITY|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.74|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.94|-0.53|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand.The change in HbA1c from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate, all nested within visit.||-0.53|-0.94|<.001
73801371|NCT02964247|147151382|SUPERIORITY||Treatment difference|-0.82|STANDARD_ERROR_OF_MEAN|0.46||0.077|TWO_SIDED|95.0|-1.73|0.09|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in body weight from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate.||0.09|-1.73|0.077
73801372|NCT02964247|147151382|SUPERIORITY|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46||0.062|TWO_SIDED|95.0|-1.77|0.04|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand. The change in body weight from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate, all nested within visit.||0.04|-1.77|0.062
73801373|NCT03918629|147151407|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for geometric mean ratio (GMR) was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.9|||||Adjusted geometric mean ratio (GMR) was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin A||0.90|0.74|
73801374|NCT03918629|147151407|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.57|||||TWO_SIDED|95.0|0.49|0.66|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean difference in logarithmic scale.|Toxin B||0.66|0.49|
73801375|NCT03918629|147151408|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-1.8|||||TWO_SIDED|95.0|-6.4|2.9|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin A||2.9|-6.4|
73801376|NCT03918629|147151408|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-16.8|||||TWO_SIDED|95.0|-21.3|-12.2|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin B||-12.2|-21.3|
73801377|NCT03918629|147151417|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.87|||||TWO_SIDED|95.0|0.8|0.95|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin A||0.95|0.80|
73801378|NCT03918629|147151417|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin B||0.81|0.62|
73801379|NCT03918629|147151418|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.7|1.7|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin A||1.7|-3.7|
73801380|NCT03918629|147151418|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-10.3|||||TWO_SIDED|95.0|-15.1|-5.5|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin B||-5.5|-15.1|
73801381|NCT01709500|147151431|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.4|||<|0.0001|TWO_SIDED|95.0|-58.1|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the placebo group using an appropriate contrast statement.||-44.8|-58.1|<0.0001
73801382|NCT01709500|147151432|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.2|||<|0.0001|TWO_SIDED|95.0|-58.7|-45.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.||-45.6|-58.7|<0.0001
73801383|NCT01709500|147151433|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-54.7|-42.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-42.2|-54.7|<0.0001
73801384|NCT01709500|147151434|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.8|||<|0.0001|TWO_SIDED|95.0|-55.0|-42.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-42.5|-55|<0.0001
73801385|NCT01709500|147151435|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.3|||<|0.0001|TWO_SIDED|95.0|-44.1|-34.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-34.5|-44.1|<0.0001
73801386|NCT01709500|147151436|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.8|||<|0.0001|TWO_SIDED|95.0|-44.5|-35.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-35.1|-44.5|<0.0001
73801387|NCT01709500|147151437|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.7|||<|0.0001|TWO_SIDED|95.0|-51.8|-39.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-39.7|-51.8|<0.0001
73801388|NCT01709500|147151438|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.4|||<|0.0001|TWO_SIDED|95.0|-52.3|-40.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-40.4|-52.3|<0.0001
73801389|NCT01709500|147151439|SUPERIORITY_OR_OTHER||LS Mean difference|-32.8|||<|0.0001|TWO_SIDED|95.0|-37.4|-28.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-28.1|-37.4|<0.0001
73801390|NCT01709500|147151440|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.5|||<|0.0001|TWO_SIDED|95.0|-39.2|-29.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-29.8|-39.2|<0.0001
73801391|NCT01709500|147151441|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.0|||<|0.0001|TWO_SIDED|95.0|-47.8|-36.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-36.2|-47.8|<0.0001
73801392|NCT01709500|147151442|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.9|||<|0.0001|TWO_SIDED|95.0|-34.5|-25.4|||Mixed Models Analysis|Threshold for significance ≤ 0.05.||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.4|-34.5|<0.0001
73801393|NCT01709500|147151443|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.8|||<|0.0001|TWO_SIDED|95.0|-66.8|-50.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-50.8|-66.8|<0.0001
73801394|NCT01709500|147151444|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|52.2|||<|0.0001|TWO_SIDED|95.0|20.9|130.0||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||130|20.9|<0.0001
73801395|NCT01709500|147151445|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.3|||<|0.0001|TWO_SIDED|95.0|21.4|132.6||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||132.6|21.4|<0.0001
73801396|NCT01709500|147151446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|239.7|||<|0.0001|TWO_SIDED|95.0|31.6|1820.3||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1820.3|31.6|<0.0001
73801397|NCT01709500|147151447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|240.6|||<|0.0001|TWO_SIDED|95.0|31.4|1841.7||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1841.7|31.4|<0.0001
73801398|NCT01709500|147151448|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-20.3|||<|0.0001|TWO_SIDED|95.0|-26.4|-14.2||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-14.2|-26.4|<0.0001
73801399|NCT01709500|147151449|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8|||=|0.0009|TWO_SIDED|95.0|2.8|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||10.7|2.8|= 0.0009
73801400|NCT01709500|147151450|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.9|||=|0.0012|TWO_SIDED|95.0|-17.5|-4.3||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure. Statistical analysis used a multiple imputation approach followed by a robust regression model.||-4.3|-17.5|= 0.0012
73801401|NCT01709500|147151451|SUPERIORITY_OR_OTHER||LS Mean Difference|4.4|||=|0.0062|TWO_SIDED|95.0|1.3|7.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||7.5|1.3|= 0.0062
73801402|NCT01709500|147151452|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.1|||<|0.0001|TWO_SIDED|95.0|-25.0|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-13.1|-25|<0.0001
73801403|NCT01709500|147151453|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|||=|0.0147|TWO_SIDED|95.0|0.9|7.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||7.8|0.9|= 0.0147
73801404|NCT01709500|147151454|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.6|||=|0.024|TWO_SIDED|95.0|-16.1|-1.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-1.1|-16.1|= 0.024
73801405|NCT01709500|147151455|SUPERIORITY_OR_OTHER||LS Mean Difference|2.3|||=|0.1475|TWO_SIDED|95.0|-0.8|5.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||5.5|-0.8|= 0.1475
73801406|NCT04581824|147151518|OTHER||Difference in Response Rate|9.32|||||TWO_SIDED|80.0|1.46|17.18|||||Mantel and Haenszel method with Sato's variance estimator was used for between arms comparison and was stratified by PD-L1 status and smoking status based on the strata data collected in interactive response technology (IRT) at randomization|||17.18|1.46|
73801407|NCT04796909|147151519|SUPERIORITY|||||||0.05|||||||Repeated-measures ANCOVA|||||||0.05
73801408|NCT04796909|147151520|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
73801409|NCT04796909|147151521|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
73801410|NCT04796909|147151522|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
73801411|NCT04796909|147151523|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
73801412|NCT04796909|147151524|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
73801413|NCT04796909|147151525|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
73801414|NCT04796909|147151526|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73801415|NCT04796909|147151527|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73801416|NCT04796909|147151528|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
73801417|NCT04162847|147151564|SUPERIORITY||Odds Ratio (OR)|0.98||||0.76|TWO_SIDED|95.0|0.88|1.1|||Regression, Logistic|||Baseline||1.10|.88|.76
73801418|NCT04162847|147151564|SUPERIORITY||Odds Ratio (OR)|0.84||||0.001|TWO_SIDED|95.0|0.76|0.93|||Regression, Logistic|||6 week follow-up||.93|.76|.001
73801419|NCT04162847|147151564|SUPERIORITY||Odds Ratio (OR)|0.82||||0|TWO_SIDED|95.0|0.74|0.9|||Regression, Logistic|||6 month follow-up||.90|.74|.000
73801420|NCT04162847|147151564|SUPERIORITY||Odds Ratio (OR)|0.86||||0.002|TWO_SIDED|95.0|0.77|0.95|||Regression, Logistic|||2 year||.95|.77|.002
73801421|NCT04162847|147151565|SUPERIORITY||Odds Ratio (OR)|6.7||||0|TWO_SIDED|95.0|5.98|7.5|||Chi-squared|||A comparison of service uptake between the intervention and control groups over the 6-month follow-up period.||7.50|5.98|.000
73801422|NCT04162847|147151565|SUPERIORITY||Odds Ratio (OR)|1.83||||0|TWO_SIDED|95.0|1.64|2.04|||Chi-squared|||A secondary analysis using the same criterion for the intervention group (access to the digital intervention during the 6-month follow-up) but expanding the control group definition to include individuals who reported having psychotherapy or starting a new medication at any point during the full 2-year follow-up period.||2.04|1.64|.000
73801423|NCT04162847|147151566|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 6 week||||.000
73801424|NCT04162847|147151566|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 6 months||||.000
73801425|NCT04162847|147151566|SUPERIORITY|||||||0.02|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 2 year||||.02
73801426|NCT04162847|147151566|SUPERIORITY|||||||0.002|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 6 week||||.002
73801427|NCT04162847|147151566|SUPERIORITY|||||||0.8|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 6 month||||.80
73801428|NCT04162847|147151566|SUPERIORITY|||||||0.51|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 2 year||||.51
73801429|NCT04162847|147151566|SUPERIORITY|||||||0.004|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 6 week||||.004
73801430|NCT04162847|147151566|SUPERIORITY|||||||0.02|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 6 month||||.02
73801431|NCT04162847|147151566|SUPERIORITY|||||||0.09|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 2 year||||.09
73801432|NCT04162847|147151566|SUPERIORITY|||||||0.66|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 6 week||||.66
73801433|NCT04162847|147151566|SUPERIORITY|||||||0.85|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 6 month||||.85
73801434|NCT04162847|147151566|SUPERIORITY|||||||0.97|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 2 year||||.97
73801435|NCT04162847|147151566|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 6 week||||.000
73801436|NCT04162847|147151566|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 6 month||||.000
73801437|NCT04162847|147151566|SUPERIORITY|||||||0.54|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 2 year||||.54
73801438|NCT04162847|147151567|SUPERIORITY|||||||0.48|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Mental component summary 6 months||||.48
73801439|NCT04162847|147151567|SUPERIORITY|||||||0.04|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Mental component summary 2 years||||.04
73801440|NCT04162847|147151567|SUPERIORITY|||||||0.97|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Physical component summary 6 months||||.97
73801441|NCT04162847|147151567|SUPERIORITY|||||||0.8|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Physical component summary 2 years||||.80
73801442|NCT00813150|147151574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.196|TWO_SIDED|95.0|0.43|1.19|||Regression, Cox|||Null Hypothesis: The (median) time to progression is equal in both treatment groups||1.19|0.43|0.196
73801443|NCT00813150|147151575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.196|TWO_SIDED|95.0|0.43|1.19|||Regression, Cox|||||1.19|0.43|0.196
73801444|NCT00813150|147151576|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.645|TWO_SIDED|95.0|0.41|1.73|||Regression, Cox|||||1.73|0.41|0.645
73801445|NCT00813150|147151577|SUPERIORITY_OR_OTHER|||||||0.814|||||||Fisher Exact|||||||0.814
73801446|NCT03664232|147151601|SUPERIORITY||Least-Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09|=|0.284|TWO_SIDED|80.0|-0.17|0.07|||Mixed effects model for repeatedmeasures|||||0.07|-0.17|=0.284
73801447|NCT03664232|147151602|SUPERIORITY||Least-Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.1|=|0.29|TWO_SIDED|80.0|-0.18|0.07|||MMRM|||||0.07|-0.18|=0.290
73801448|NCT03664232|147151603|SUPERIORITY||Least-Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.1|=|0.231|TWO_SIDED|80.0|-0.21|0.06|||MMRM|||||0.06|-0.21|=0.231
73801449|NCT01062425|147151721|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||One-sided test with significance level of 0.15.|Z-test|||The null hypothesis was that the 6m PFS rates for both arms are 50%, and the alternative hypothesis was that patients receiving the experimental regimen would have a 6-month PFS rate of 66%. With 150 eligible patients, there would be an 80% statistical power to detect the 16% absolute increase in 6m PFS at a significance level of 0.15, using a one-sided Z test for two proportions.||||0.005
73801450|NCT01062425|147151722|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.44|TWO_SIDED|95.0|0.6|1.24||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.|||1.24|0.6|0.44
73801451|NCT01062425|147151722|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.648|TWO_SIDED|95.0|0.62|1.34|||Regression, Cox||Placebo is reference level for the hazard ratio.|Multivariate analysis with the Cox proportional hazard model for overall survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and RPA risk class.||1.34|0.62|0.648
73801452|NCT01062425|147151723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.03|TWO_SIDED|95.0|0.47|0.95||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.|||0.95|0.47|0.03
73801453|NCT01062425|147151723|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.036|TWO_SIDED|95.0|0.46|0.97|||Regression, Cox||Placebo is the reference arm.|Multivariate analysis with the Cox proportional hazard model for progression-free survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and recursive partitioning analysis (RPA) risk class.||0.97|0.46|0.036
73801454|NCT01062425|147151724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||Significance level 0.05, two-sided test.|Chi-squared|||||||0.02
73801455|NCT02342678|147151725|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.13|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|||||2.2|-0.3|0.13
73801456|NCT02342678|147151726|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.18|TWO_SIDED|95.0|-0.2|1.1|||ANCOVA|||||1.1|-0.2|0.18
73801457|NCT02342678|147151727|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.89|TWO_SIDED|95.0|-1.2|1.3|||ANCOVA|||||1.3|-1.2|0.89
73801458|NCT02342678|147151728|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.13|TWO_SIDED|95.0|-0.3|2.0|||ANCOVA|||||2.0|-0.3|0.13
73801459|NCT02342678|147151729|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.73|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||||0.4|-0.3|0.73
73801460|NCT02342678|147151730|SUPERIORITY||Mean Difference (Final Values)|-19.3||||0.38|TWO_SIDED|95.0|-62.9|24.3|||ANCOVA|||||24.3|-62.9|0.38
73801461|NCT02342678|147151731|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.24|TWO_SIDED|95.0|-3.7|14.8|||ANCOVA|||||14.8|-3.7|0.24
73801462|NCT02342678|147151732|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|||||0.9|-0.4|0.46
73894352|NCT02191865|147321205|SUPERIORITY_OR_OTHER||ratio of the geometric means|215.39|STANDARD_DEVIATION|73.5|||TWO_SIDED|90.0|120.71|384.32|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||384.32|120.71|
73894353|NCT02191865|147321205|SUPERIORITY_OR_OTHER||Ratio of geometric means|867.13|STANDARD_DEVIATION|45.9|||TWO_SIDED|90.0|572.93|1312.41|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1312.41|572.93|
73894354|NCT02191865|147321206|SUPERIORITY_OR_OTHER||ratio of the geometric means|221.76|STANDARD_DEVIATION|61.4|||TWO_SIDED|90.0|134.73|365.01|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||365.01|134.73|
73894355|NCT02191865|147321206|SUPERIORITY_OR_OTHER||Ratio of geometric means|761.01|STANDARD_DEVIATION|69.1|||TWO_SIDED|90.0|439.01|1319.18|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1319.18|439.01|
73894356|NCT02191865|147321207|SUPERIORITY_OR_OTHER||ratio of the geometric means|216.79|STANDARD_DEVIATION|75.0|||TWO_SIDED|90.0|120.37|390.45|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||390.45|120.37|
73894357|NCT02191865|147321207|SUPERIORITY_OR_OTHER||Ratio of geometric means|870.74|STANDARD_DEVIATION|45.7|||TWO_SIDED|90.0|576.36|1315.49|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1315.49|576.36|
73801463|NCT00460603|147151742|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.585||||0.9726|TWO_SIDED|95.0|0.332|1.031|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes versus \[vs.\] no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.031|0.332|0.9726
73801464|NCT00460603|147151742|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.735||||0.8391|TWO_SIDED|95.0|0.399|1.352|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.352|0.399|0.8391
73801465|NCT00460603|147151742|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.797||||0.8192|TWO_SIDED|95.0|0.489|1.299|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.299|0.489|0.8192
73801466|NCT00460603|147151774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.5699|TWO_SIDED|95.0|0.47|2.45|||Log Rank|||Hazard ratio and corresponding 95% confidence interval (CI) was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.45|0.47|0.5699
73801467|NCT00460603|147151774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.2167|TWO_SIDED|95.0|0.33|1.61|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.61|0.33|0.2167
73801468|NCT00460603|147151774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.8746|TWO_SIDED|95.0|0.75|2.98|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.98|0.75|0.8746
73894358|NCT04693234|147321209|SUPERIORITY|||||||0.0054|||||||Binomial Exact Test|The p-value was calculated from the binomial exact test of tislelizumab combined with ociperlimab versus historical rate of 0.15.||||||0.0054
73894359|NCT04693234|147321210|SUPERIORITY|||||||0.0127|||||||Binomial Exact Test|The p-value was calculated from the binomial exact test of tislelizumab combined with ociperlimab versus historical rate of 0.15.||||||0.0127
73894360|NCT04643158|147321230|SUPERIORITY||Least Square Mean Difference|0.0236||||0.828|TWO_SIDED|95.0|-0.1934|0.2406|||Mixed Models Analysis|||||0.2406|-0.1934|0.828
73894361|NCT04643158|147321230|SUPERIORITY||Least Square Mean Difference|0.196||||0.035|TWO_SIDED|95.0|0.0143|0.3778|||Mixed Models Analysis|||||0.3778|0.0143|0.035
73894362|NCT04643158|147321250|SUPERIORITY||Geometric Least Square Mean Ratio|-38.31||||0.202|TWO_SIDED|95.0|-71.11|31.72|||Mixed Models Analysis||Analyses were done on the natural log scale and the results were back-transformed to linear scale.|||31.72|-71.11|0.202
73801469|NCT00460603|147151775|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8884|TWO_SIDED|95.0|0.81|2.41|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.41|0.81|0.8884
73801470|NCT00460603|147151775|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.6648|TWO_SIDED|95.0|0.66|1.89|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.89|0.66|0.6648
73801471|NCT00460603|147151775|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.8065|TWO_SIDED|95.0|0.75|2.07|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.07|0.75|0.8065
73801472|NCT00460603|147151776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.155||||0.6904|TWO_SIDED|95.0|0.656|2.033|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.033|0.656|0.6904
73801473|NCT00460603|147151776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.203||||0.7364|TWO_SIDED|95.0|0.676|2.141|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.141|0.676|0.7364
73801474|NCT00460603|147151776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.414|TWO_SIDED|95.0|0.535|1.653|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.653|0.535|0.4140
73801475|NCT00289848|147151778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|STANDARD_DEVIATION|1.08|<|0.001||95.0|-1.23|-0.83|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline A1C as a covariate||||-0.83|-1.23|<0.001
73801476|NCT00289848|147151779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|STANDARD_DEVIATION|39.8|<|0.001||95.0|-38.4|-23.7|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline FPG as a covariate||||-23.7|-38.4|<0.001
73801477|NCT00289848|147151780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-56.6|STANDARD_DEVIATION|59.2|<|0.001||95.0|-68.8|-44.3|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline 2-hr PMG as a covariate||||-44.3|-68.8|<0.001
73801478|NCT00860795|147151781|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|||||||.17
73801479|NCT00860795|147151782|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|95.0|||||Regression, Linear|||||||.72
73801480|NCT00860795|147151783|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0|||||Regression, Linear|||||||.2
73894363|NCT04643158|147321250|SUPERIORITY||Geometric Least Square Mean Ratio|-15.43||||0.596|TWO_SIDED|95.0|-55.57|60.96|||Mixed Models Analysis||Analyses were done on the natural log scale and the results were back-transformed to linear scale.|||60.96|-55.57|0.596
73801481|NCT00860795|147151785|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|95.0|||||Regression, Linear|||||||.51
73801482|NCT00860795|147151786|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Regression, Linear|||||||.43
73801483|NCT00860795|147151787|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|95.0|||||Regression, Linear|||||||.61
73801484|NCT03871543|147151788|OTHER|Statistical Difference|Mean difference|0.159|STANDARD_ERROR_OF_MEAN|0.287|||ONE_SIDED|95.0|-0.402||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|Upper Lid|||-0.402|
73801485|NCT03871543|147151788|OTHER|Statistical Difference|Mean Difference|0.236|STANDARD_ERROR_OF_MEAN|0.289|||ONE_SIDED|95.0|-0.328||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|Lower Lid|||-0.328|
73801486|NCT03871543|147151789|OTHER|Statistical difference|Mean Ratio|0.918|||||ONE_SIDED|95.0||1.227|||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean ratio was calculated as Symptomatic divided by Asymptomatic|||1.227||
73801487|NCT03871543|147151790|OTHER|Statistical difference|Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.019|||ONE_SIDED|95.0||0.022|||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|||0.022||
73801488|NCT03871543|147151791|OTHER|Statistical difference|Mean Difference|1.185|STANDARD_ERROR_OF_MEAN|3.483|||ONE_SIDED|95.0|-4.613||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic||||-4.613|
73801489|NCT03871543|147151792|OTHER|Statistical difference|Mean Ratio|1.984|||||ONE_SIDED|95.0|1.198||||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean Ratio was calculated as Symptomatic divided by Asymptomatic|Upper Lid|||1.198|
73801490|NCT03871543|147151792|OTHER|Statistical Difference|Mean Ratio|1.8|||||ONE_SIDED|95.0|1.093||||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean Ratio was calculated as Symptomatic divided by Asymptomatic|Lower Lid|||1.093|
73801491|NCT03871543|147151793|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1416||||0.3446|TWO_SIDED|95.0|-0.4148|0.1551|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1551|-0.4148|0.3446
73894364|NCT01474018|147321270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
73894365|NCT01474018|147321271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
73801492|NCT03871543|147151794|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0887||||0.5556|TWO_SIDED|95.0|-0.207|0.3694|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3694|-0.2070|0.5556
73801493|NCT03871543|147151795|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2052||||0.1676|TWO_SIDED|95.0|-0.4676|0.0905|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0905|-0.4676|0.1676
73801494|NCT03871543|147151796|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0903||||0.5483|TWO_SIDED|95.0|-0.2054|0.3709|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3709|-0.2054|0.5483
73801495|NCT03871543|147151797|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2679||||0.0719|TWO_SIDED|95.0|-0.5205|0.0278|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0278|-0.5205|0.0719
73801496|NCT03871543|147151798|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.3434||||0.019|TWO_SIDED|95.0|-0.5786|0.0554|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0554|-0.5786|0.0190
73801497|NCT03871543|147151799|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2975||||0.042|TWO_SIDED|95.0|-0.541|-0.0078|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||-0.0078|-0.5410|0.0420
73801498|NCT03871543|147151800|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.127||||0.3973|TWO_SIDED|95.0|-0.1696|0.4024|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.4024|-0.1696|0.3973
73801499|NCT03871543|147151801|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.021||||0.8894|TWO_SIDED|95.0|-0.3094|0.271|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.2710|-0.3094|0.8894
73801500|NCT03871543|147151802|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0762||||0.6129|TWO_SIDED|95.0|-0.219|0.3585|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3585|-0.2190|0.6129
73801501|NCT03871543|147151803|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1402||||0.3493|TWO_SIDED|95.0|-0.4137|0.1565|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1565|-0.4137|0.3493
73801502|NCT03871543|147151804|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1192||||0.427|TWO_SIDED|95.0|-0.3958|0.1772|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1772|-0.3958|0.4270
73801503|NCT04242498|147151834|SUPERIORITY||Odds Ratio (OR)|2.422||||0.004|TWO_SIDED|97.5|1.221|4.804|||Regression, Logistic|||||4.804|1.221|0.004
73801504|NCT04242498|147151834|SUPERIORITY||Odds Ratio (OR)|2.287||||0.003|TWO_SIDED|97.5|1.22|4.291|||Regression, Logistic|||||4.291|1.220|0.003
73801505|NCT04242498|147151835|SUPERIORITY||Odds Ratio (OR)|2.722||||0.007|TWO_SIDED|97.5|1.182|6.267|||Regression, Logistic|||||6.267|1.182|0.007
73801506|NCT04242498|147151835|SUPERIORITY||Odds Ratio (OR)|3.007||||0.002|TWO_SIDED|97.5|1.374|6.581|||Regression, Logistic|||||6.581|1.374|0.002
73801507|NCT04242498|147151836|SUPERIORITY||Odds Ratio (OR)|0.798||||0.497|TWO_SIDED|97.5|0.378|1.683|||Regression, Logistic|||||1.683|0.378|0.497
73801508|NCT04242498|147151836|SUPERIORITY||Odds Ratio (OR)|1.05||||0.868|TWO_SIDED|97.5|0.541|2.041|||Regression, Logistic|||||2.041|0.541|0.868
73801509|NCT04242498|147151837|SUPERIORITY||LS mean difference|-2.393|||<|0.001|TWO_SIDED|97.5|-3.92|-0.867||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.867|-3.920|<0.001
73801510|NCT04242498|147151837|SUPERIORITY||LS mean difference|-2.309|||<|0.001||97.5|-3.705|-0.914||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.914|-3.705|<0.001
73801511|NCT04242498|147151838|SUPERIORITY||LS mean difference|-0.898||||0.01|TWO_SIDED|97.5|-1.684|-0.113||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.113|-1.684|0.010
73801512|NCT04242498|147151838|SUPERIORITY||LS mean difference|-1.265|||<|0.001|TWO_SIDED|97.5|-1.978|-0.552||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.552|-1.978|<0.001
73801513|NCT04242498|147151839|SUPERIORITY||Odds Ratio (OR)|3.273||||0.028|TWO_SIDED|97.5|0.974|10.997||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|Regression, Logistic|||||10.997|0.974|0.028
73801514|NCT04242498|147151839|SUPERIORITY||Odds Ratio (OR)|3.756||||0.01|TWO_SIDED|97.5|1.189|11.867||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|Regression, Logistic|||||11.867|1.189|0.010
73801515|NCT03197389|147151856|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|||||||||||||
73801516|NCT04129125|147151857|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|83.4|||<|0.0001|TWO_SIDED|95.0|78.0|88.0||The p-value a priori threshold for statistical significance was \<0.025|Fisher Exact|||The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%||88|78|<0.0001
73801517|NCT04129125|147151858|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|1.9|||||TWO_SIDED|95.0|0.6|4.4||||||The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%||4.4|0.6|
73894366|NCT01474018|147321271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
73894367|NCT02433080|147321273|OTHER||Mean Difference (Net)|6.4||||0.05|TWO_SIDED|95.0|-3.6|16.5|||ANCOVA|||This statistical analysis applies for the outcomes 2-8.||16.5|-3.6|0.05
73801518|NCT04129125|147151859|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|84.0||||0.0001|TWO_SIDED|95.0|78.0|89.0||The p-value a priori threshold for statistical significance was \<0.025|Fisher Exact|||The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%||89|78|0.0001
73801519|NCT04129125|147151860|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|0.9|||||TWO_SIDED|95.0|0.1|3.4||||||The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%||3.4|0.1|
73801520|NCT04129125|147151869|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|12.7|||||TWO_SIDED|95.0|8.5|16.7|||||Event and CI estimated using Kaplan-Meier method|The FDA agreed performance goal for the all-cause mortality endpoint was for the observed rate to be ≤20.3%||16.7|8.5|
73801521|NCT04129125|147151880|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|12.3|||||TWO_SIDED|95.0|8.1|17.2|||||Event and CI estimated using Kaplan-Meier method|The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤20.3%||17.2|8.1|
73801522|NCT01268527|147151953|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|711.4||||0.0038|TWO_SIDED|95.0|292.5|1130.3|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, Least Squares Means (LSM), and Confidence Intervals (CI) were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1130.3|292.5|0.0038
73801523|NCT01268527|147151953|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|1119.8|||<|0.0001|TWO_SIDED|95.0|858.9|1380.6|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1380.6|858.9|<0.0001
73801524|NCT01268527|147151953|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|780.0||||0.0523|TWO_SIDED|95.0|-8.5|1568.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1568.5|-8.5|0.0523
73801525|NCT01268527|147151953|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|1775.1|||<|0.0001|TWO_SIDED|95.0|1392.3|2158.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||2158.0|1392.3|<0.0001
73801526|NCT01268527|147151953|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|921.4||||0.0002|TWO_SIDED|95.0|515.7|1327.1|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1327.1|515.7|0.0002
73801527|NCT01268527|147151953|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|937.8||||0.0115|TWO_SIDED|95.0|267.6|1607.9|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1607.9|267.6|0.0115
73801528|NCT01268527|147151954|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|101.5||||0.0042|TWO_SIDED|95.0|36.0|167.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||167.0|36.0|0.0042
73801529|NCT01268527|147151954|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|182.4|||<|0.0001|TWO_SIDED|95.0|140.3|224.4|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||224.4|140.3|<0.0001
73801530|NCT01268527|147151954|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|169.5|||<|0.0001|TWO_SIDED|95.0|127.4|211.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||211.5|127.4|<0.0001
73801531|NCT01268527|147151954|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|246.6|||<|0.0001|TWO_SIDED|95.0|185.0|308.1|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||308.1|185.0|<0.0001
73801532|NCT01268527|147151954|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|132.3||||0.0043|TWO_SIDED|95.0|53.9|210.7|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||210.7|53.9|0.0043
73801533|NCT01268527|147151954|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|145.0||||0.0036|TWO_SIDED|95.0|64.2|225.8|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM) and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||225.8|64.2|0.0036
73801534|NCT01268527|147151955|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|80.7||||0.0013|TWO_SIDED|95.0|34.6|126.7|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||126.7|34.6|0.0013
73801535|NCT01268527|147151955|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|127.9|||<|0.0001|TWO_SIDED|95.0|92.4|163.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||163.5|92.4|<0.0001
73801536|NCT01268527|147151955|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|110.2||||0.0458|TWO_SIDED|95.0|2.4|218.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||218.0|2.4|0.0458
73801537|NCT01268527|147151955|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|207.5|||<|0.0001|TWO_SIDED|95.0|155.2|259.9|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||259.9|155.2|<0.0001
73801538|NCT01268527|147151955|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|125.3||||0.0003|TWO_SIDED|95.0|71.5|179.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||179.0|71.5|0.0003
73801539|NCT01268527|147151955|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|128.6||||0.0029|TWO_SIDED|95.0|93.9|163.3|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||163.3|93.9|0.0029
73801540|NCT00908544|147151966|OTHER|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|0.2||||0.98|TWO_SIDED|95.0|0.0|0.4|||t-test, 1 sided|||||0.4|0.0|0.98
73801541|NCT00908544|147151966|OTHER|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|-1.4|||<|0.01|TWO_SIDED|95.0|-1.7|-1.1|||t-test, 1 sided|||||-1.1|-1.7|<0.01
73801542|NCT00908544|147151966|OTHER|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|0.12||||0.93|TWO_SIDED|95.0|-0.1|0.3|||t-test, 1 sided|||||0.3|-0.1|0.93
73801543|NCT00908544|147151966|OTHER|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|-1.3|||<|0.01|TWO_SIDED|95.0|-1.6|-1.0|||t-test, 1 sided|||||-1.0|-1.6|<0.01
73801544|NCT00908544|147151967|OTHER|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|0.2||||0.99|TWO_SIDED|95.0|0.0|0.4|||t-test, 1 sided|||||0.4|0.0|0.99
73801545|NCT00908544|147151967|OTHER|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|-1.7|||<|0.01|TWO_SIDED|95.0|-2.0|-1.5|||t-test, 1 sided|||||-1.5|-2.0|<0.01
73801546|NCT00908544|147151967|OTHER|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|0.2||||0.97|TWO_SIDED|95.0|0.0|0.3|||t-test, 1 sided|||||0.3|-0.0|0.97
73801547|NCT00908544|147151967|OTHER|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|-1.7|||<|0.01|TWO_SIDED|95.0|-2.0|-1.4|||t-test, 1 sided|||||-1.4|-2.0|<0.01
73801548|NCT03888469|147151990|NON_INFERIORITY|Non-inferiority margin = 0.05|Least Squares Mean Difference|0.0|||||ONE_SIDED|95.0||0.0|||Mixed effects repeated measures model|Mixed effects repeated measures model with terms for lens, period and sequence as fixed effects and subject as a random effect.|Difference = DDT2 - Moist|||0.00||
73801549|NCT01609790|147152047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||Z-test|One-sided test, significance level 0.15||Assuming a 36% 6-month (6m) rate in the placebo arm \[from the March 2009 Food and Drug Administration (FDA) briefing\], a 55% rate in the AMG 386 arm, and an exponential distribution corresponds to median PFS of 4.1 and 7 months, respectively, with a hazard ratio of 0.59 (AMG 386 arm vs. placebo arm). A total of 114 patients (57 per arm) will yield 85% power to detect an absolute 19% difference of 6m PFS rate at a 1-sided alpha level of 0.15 based on a 2-sample proportion test.||||0.98
73801550|NCT01609790|147152048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|||||||Chi-squared|||||||0.85
73801551|NCT01609790|147152049|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.46||||0.09|TWO_SIDED|95.0|0.95|2.27|||Log Rank|||||2.27|0.95|0.09
73801552|NCT01609790|147152050|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.51||||0.04|TWO_SIDED|95.0|1.02|2.24|||Log Rank|||||2.24|1.02|0.04
73801553|NCT01609790|147152051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Chi-squared|||||||0.7
73801554|NCT05022667|147152068|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
73801555|NCT05022667|147152069|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||.5
73801556|NCT05022667|147152070|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||.2
73801557|NCT05022667|147152071|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
73801558|NCT05022667|147152072|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||.4
73801559|NCT05022667|147152074|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||.3
73801560|NCT03103087|147152157|SUPERIORITY||Treatment Difference|56.47|||<|0.0001|TWO_SIDED|95.0|46.45|66.49||P-value was stratified by baseline MBL volume (\< 225 mL or ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo.|||66.49|46.45|<0.0001
73894368|NCT01015638|147321293|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
73894369|NCT01015638|147321294|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|||||||>0.05
73894370|NCT01015638|147321295|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
73801561|NCT03103087|147152158|SUPERIORITY||Treatment Difference|47.3|||<|0.0001|TWO_SIDED|95.0|38.04|56.56||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel|Treatment difference was relugolix plus E2/NETA minus placebo. 95% confidence interval (CI) for the difference is based on the normal approximation.||||56.56|38.04|<0.0001
73801562|NCT03103087|147152159|SUPERIORITY||Treatment Difference|-69.2|STANDARD_ERROR_OF_MEAN|7.58|<|0.0001|TWO_SIDED|95.0|-84.1|-54.3||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. Assessed at a 2-sided α = 0.05 significance.|Mixed Models Analysis||Treatment difference was relugolix plus E2/NETA minus placebo.|||-54.3|-84.1|<0.0001
73801563|NCT03103087|147152160|SUPERIORITY||Treatment Difference|55.88|||<|0.0001|TWO_SIDED|95.0|37.25|74.52||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||74.52|37.25|<0.0001
73801564|NCT03103087|147152161|SUPERIORITY||Treatment Difference|29.99|||<|0.0001|TWO_SIDED|95.0|15.6|44.38||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||44.38|15.6|<0.0001
73801565|NCT03103087|147152162|SUPERIORITY||Treatment Difference|-10.0|STANDARD_ERROR_OF_MEAN|8.03|=|0.2153|TWO_SIDED|95.0|-25.8|5.8||LS Means based on analysis of covariance model including treatment, randomization stratification factors, Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World), and Baseline values as covariate.|ANCOVA|||||5.8|-25.8|=0.2153
73801566|NCT03103087|147152163|SUPERIORITY||Treatment Difference|-12.2|STANDARD_ERROR_OF_MEAN|4.57|=|0.0078|TWO_SIDED|95.0|-21.3|-3.2||LS Means based on analysis of covariance model including treatment, randomization stratification factors, Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World), and Baseline values as covariate.|ANCOVA|||||-3.2|-21.3|=0.0078
73801567|NCT03103087|147152164|SUPERIORITY||Treatment Difference|-33.4|STANDARD_ERROR_OF_MEAN|3.98|<|0.0001|TWO_SIDED|95.0|-41.2|-25.5||Assessed at a 2-sided α = 0.05 significance level.|Mixed Models Analysis||Relugolix plus E2/NETA minus placebo. Treatment, visit, region, Baseline MBL and treatment by visit interaction as fixed effects.|||-25.5|-41.2|<0.0001
73801568|NCT03103087|147152167|OTHER||Risk Ratio (RR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.07|0.33|||Fisher Exact|||||0.33|0.07|<0.0001
73801569|NCT03103087|147152172|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||< 0.0001
73801570|NCT03103087|147152173|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
73801571|NCT03103087|147152174|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||<0.0001
73801572|NCT03103087|147152175|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||< 0.0001
73801573|NCT03103087|147152176|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||<0.0001
73801574|NCT03103087|147152177|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
73801575|NCT03103087|147152178|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World). Lower limit of normal is Hgb \< 11.6 g/dL.|Cochran-Mantel-Haenszel|||||||<0.0001
73801576|NCT03103087|147152179|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included.|Mixed Models Analysis|||||||<0.0001
73801577|NCT03103087|147152180|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
73801578|NCT03103087|147152181|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
73801579|NCT03103087|147152182|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
73801580|NCT03103087|147152183|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
73801581|NCT03103087|147152184|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included.|Mixed Models Analysis|||||||<0.0001
73801582|NCT03103087|147152185|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
73894371|NCT01015638|147321296|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Tukey-Kramer Multiple Comparisons Test|||||||> 0.05
73894372|NCT05487196|147321309|NON_INFERIORITY|The noninferiority margin δ was set as the median of fentanyl group + 30 representing a 1-point pain numeric rating scale difference per unit time across the 30-minute initiation period. A conventional 1-sided 95% confidence interval (CI) was constructed using normal distribution assumptions. Analysis was by intent to treat. Comparisons of PI-AUC30 between the three agents were made by one-way ANOVA.||||||0.226|||||||ANOVA|||||||0.226
73894373|NCT05487196|147321310|SUPERIORITY|||||||0.16|||||||ANOVA|||||||0.16
73894374|NCT05487196|147321311|SUPERIORITY|||||||0.03|||||||ANOVA|||||||0.03
73894375|NCT05487196|147321312|SUPERIORITY|||||||0.07|||||||ANOVA|||||||0.07
73894376|NCT05487196|147321313|SUPERIORITY|||||||0.22|||||||ANOVA|||||||0.22
73894377|NCT05487196|147321314|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.28
73894378|NCT05487196|147321315|SUPERIORITY|||||||0.83|||||||Fisher Exact|||||||0.83
73894379|NCT05487196|147321316|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
73894380|NCT05487196|147321317|SUPERIORITY|||||||0.36|||||||Fisher Exact|||||||0.36
73894381|NCT05487196|147321318|SUPERIORITY|||||||0.36|||||||Fisher Exact|||||||0.36
73894382|NCT05487196|147321319|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
73894383|NCT05487196|147321320|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||0.58
73894384|NCT05487196|147321321|SUPERIORITY|||||||0.98|||||||Kruskal-Wallis|||||||0.98
73894385|NCT00711477|147321325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|90.0|0.5|0.9||||||||0.90|0.50|
73894386|NCT00711477|147321326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.38|TWO_SIDED|95.0|-1.83|0.72|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.72|-1.83|0.380
73894387|NCT00711477|147321327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.744|TWO_SIDED|95.0|-2.87|2.07|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||2.07|-2.87|0.744
73894388|NCT00711477|147321328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.64||||0.139|TWO_SIDED|95.0|-3.84|0.56|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.56|-3.84|0.139
73894389|NCT00711477|147321329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.094|TWO_SIDED|95.0|-2.96|0.24|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.24|-2.96|0.094
73894390|NCT00711477|147321330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.48||||0.102|TWO_SIDED|95.0|-5.48|0.51|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.51|-5.48|0.102
73894391|NCT00711477|147321331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.4||||0.16||95.0|-22.7|3.89|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||3.89|-22.7|0.160
73894392|NCT00711477|147321332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|90.0|0.4|0.8||||||||0.80|0.40|
73894393|NCT00711477|147321333|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.75|||||TWO_SIDED|90.0|0.5|1.0||||||||1.00|0.50|
73894394|NCT00711477|147321334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||||TWO_SIDED|90.0|0.74|1.24||||||||1.24|0.74|
73894395|NCT00711477|147321335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|90.0|0.95|1.65||||||||1.65|0.95|
73894396|NCT00711477|147321336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||||TWO_SIDED|90.0|0.31|0.57||||||||0.57|0.31|
73894397|NCT02448641|147321338|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6743|TWO_SIDED|95.0|0.35|5.09||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||5.09|0.35|0.6743
73894398|NCT02448641|147321339|SUPERIORITY||Odds Ratio (OR)|0.43||||0.1|TWO_SIDED|95.0|0.15|1.18||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with mRS responder as outcome, treatment, visit, treatment-visit interaction, pooled site and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||1.18|0.15|0.1000
73894399|NCT02448641|147321342|SUPERIORITY||Mean Difference (Net)|-0.36||||0.7788|TWO_SIDED|95.0|-2.9|2.17||Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): -0.36 (1.283)|Statistical analysis: NeuroQOL score for the Upper Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)||2.17|-2.90|0.7788
73894400|NCT02448641|147321342|SUPERIORITY||Mean Difference (Net)|0.58||||0.5347|TWO_SIDED|95.0|-1.26|2.43||Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): 0.58 (0.934)|Statistical Analysis: NeuroQOL score for Lower Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)||2.43|-1.26|0.5347
73894401|NCT02448641|147321344|SUPERIORITY||Mean Difference (Net)|1.2||||0.2959|TWO_SIDED|95.0|-1.1|3.6||MMRM: Mixed effect Model Repeat Measurement|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): 1.2 (1.18)|"Change from Baseline at Month 6~Between-group Effect size is calculated as the LS mean difference divided by the model estimate of the pooled SD, obtained from the square root of the diagonal element, associated with the analysis visit summarized, from the covariance matrix."||3.6|-1.1|0.2959
73894402|NCT02448641|147321345|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6854|TWO_SIDED|95.0|0.31|5.92||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||5.92|0.31|0.6854
73894403|NCT00884741|147321358|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13||||0.11|TWO_SIDED|95.0|0.93|1.37||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).||1.37|0.93|0.11
73894404|NCT00884741|147321359|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.79||||0.004|TWO_SIDED|95.0|0.66|0.94||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).||0.94|0.66|0.004
73894405|NCT00884741|147321360|SUPERIORITY_OR_OTHER|||||||0.42||||||Two-sided|Chi-squared|||||||0.42
73894406|NCT01014910|147321363|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||Based on a previously-identified mean LOS of 65.3 hours, we estimated we would need to enroll 80 patients in each study arm to provide adequate sample size to detect a difference in mean LOS of 18 hours with 80% power and alpha=0.05.|Wilcoxon (Mann-Whitney)|Sample size calculations were performed using Power and Sample Size Calculator, version 3.0 (by developers William D. Dupont and Walton D. Plummer Jr)||Differences in LOS were compared between study arms using the Mann-Whitney U-test and the Kaplan-Meier method. Statistical analyses were performed using Stata version 13.1 for Windows (StataCorp). All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).||||<0.05
73894407|NCT01014910|147321364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Chi-squared, Corrected|||The proportion of patients transferred to the intensive care unit in each study arm was compared between study arms using the Pearson χ2 test. All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).||||0.05
73894408|NCT01215097|147321379|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.7|-0.34|||ANCOVA|||||-0.34|-0.70|<0.0001
73894409|NCT01215097|147321380|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.433|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.555|-0.311|||ANCOVA|||||-0.311|-0.555|<0.0001
73894410|NCT01215097|147321381|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.591|STANDARD_ERROR_OF_MEAN|0.082|<|0.0001||95.0|-0.752|-0.43|||ANCOVA|||||-0.43|-0.752|<0.0001
73894411|NCT01215097|147321382|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.7|-0.35|||ANCOVA|||||-0.35|-0.70|<0.0001
73894412|NCT01215097|147321383|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.71|-0.32|||ANCOVA|||||-0.32|-0.71|<0.0001
73894413|NCT01215097|147321384|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.6|STANDARD_ERROR_OF_MEAN|4.2||0.0233||95.0|-17.8|-1.3|||ANCOVA|||||-1.3|-17.8|0.0233
73894414|NCT01215097|147321385|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.1|STANDARD_ERROR_OF_MEAN|3.3|<|0.0001||95.0|-28.7|-15.6|||ANCOVA|||||-15.6|-28.7|<0.0001
73894415|NCT01215097|147321386|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.2|STANDARD_ERROR_OF_MEAN|3.6||0.005||95.0|-17.3|-3.1|||ANCOVA|||||-3.1|-17.3|0.0050
73894416|NCT01215097|147321387|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.5|STANDARD_ERROR_OF_MEAN|4.0||0.0044||95.0|-19.5|-3.6|||ANCOVA|||||-3.6|-19.5|0.0044
73894417|NCT01215097|147321389|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.243|||<|0.0001||95.0|2.831|13.769|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>=7.0%||13.769|2.831|<0.0001
73894418|NCT01215097|147321391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97||||0.0129||95.0|1.404|17.592|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>= 6.5%||17.592|1.404|0.0129
73894419|NCT01215097|147321392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.054|||<|0.0001||95.0|1.799|5.185|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with HbA1c at least lowering 0.5% from baseline||5.185|1.799|<0.0001
73894420|NCT01818752|147321404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.906||||0.159|TWO_SIDED|95.0|0.746|1.101||The p-value boundary for PFS analysis was 0.02141.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.|The inferential test associated with the primary analysis of PFS was assessed against an overall 1-sided significance level of α=0.025.||1.101|0.746|0.1590
73801583|NCT03103087|147152186|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
73894421|NCT01818752|147321405|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.211||||0.8934|TWO_SIDED|95.0|0.896|1.637||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.637|0.896|0.8934
73894422|NCT01818752|147321406|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.412||||0.0218|TWO_SIDED|95.0|1.01|1.973||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.973|1.010|0.0218
73801584|NCT03103087|147152187|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
73801585|NCT03103087|147152189|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
73801586|NCT03103087|147152196|SUPERIORITY|||||||0.0004||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||0.0004
73801587|NCT03504397|147152201|SUPERIORITY||Hazard Ratio (HR)|0.734||||0.0024|TWO_SIDED|95.0|0.591|0.91||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||0.910|0.591|0.0024
73801588|NCT03504397|147152202|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.0075|TWO_SIDED|95.0|0.644|0.954||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||0.954|0.644|0.0075
73801589|NCT03504397|147152203|SUPERIORITY||Hazard Ratio (HR)|1.295||||0.028|TWO_SIDED|95.0|0.994|1.687||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||1.687|0.994|0.0280
73801590|NCT03504397|147152204|SUPERIORITY||Hazard Ratio (HR)|0.713||||0.0508|TWO_SIDED|95.0|0.475|1.071||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||1.071|0.475|0.0508
73801591|NCT03504397|147152205|SUPERIORITY||Hazard Ratio (HR)|1.142||||0.1685|TWO_SIDED|95.0|0.874|1.492|||Log Rank||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|||1.492|0.874|0.1685
73801592|NCT03504397|147152206|SUPERIORITY|||||||0.4536|||||||Cochran-Mantel-Haenszel|Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.||||||0.4536
73801593|NCT03504397|147152207|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.0721|TWO_SIDED|95.0|0.573|1.087|||Log Rank||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|||1.087|0.573|0.0721
73801594|NCT04231825|147152259|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
73801595|NCT04231825|147152260|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
73801596|NCT04231825|147152261|SUPERIORITY|||||||0.8|||||||ANCOVA|||||||0.80
73801597|NCT04231825|147152262|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
73801598|NCT04231825|147152263|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
73801599|NCT01662635|147152264|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were summarized as arithmetic means, medians and standard deviations; and categorical variables were reported as proportions with 95% confidence intervals. Inferential comparisons were performed using Student's t test. The x2 or Fisher's exact tests were used to assess significance among categorical variables.||||< 0.05
73801600|NCT03190993|147152296|OTHER|Linear mixed effect models were used to test if changes (Day 28 - Baseline) were equal between treatment groups (primary outcome).|Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.43|=|0.22|TWO_SIDED||||||Regression, Linear|||||||=0.22
73801601|NCT03588910|147152311|SUPERIORITY|Wilcoxon rank-sum tests||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||.87
73801602|NCT03588910|147152312|SUPERIORITY|Wilcoxon rank-sum tests||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||.36
73801603|NCT03588910|147152313|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||.91
73801604|NCT03588910|147152314|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.29
73801605|NCT03588910|147152315|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||.36
73801606|NCT00611923|147152316|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.57|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 1 between flutamide and placebo groups||||= 0.57
73801607|NCT00611923|147152316|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.27|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 2 between flutamide and placebo groups.||||= .27
73801608|NCT00611923|147152317|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.52|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 1 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.||||= 0.52
73801609|NCT00611923|147152317|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 2 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.||||= 0.2
73801610|NCT00611923|147152318|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.8|||||||t-test, 2 sided|||||||= 0.8
73801611|NCT00611923|147152318|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.1|||||||t-test, 2 sided|||||||= 0.1
73801612|NCT00611923|147152319|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.15|||||||t-test, 2 sided|||paired t-test was performed comparing the Clinical Global Improvement score at month 1 between placebo and flutamide groups||||=.15
73801613|NCT00611923|147152319|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.05|||||||t-test, 2 sided|||t-test was performed comparing the Clinical Global Improvement score at month 2 between placebo and flutamide groups||||= .05
73801614|NCT00611923|147152320|SUPERIORITY_OR_OTHER_LEGACY|Comparison of change from baseline score to treatment month 1 between placebo and flutamide treated subjects.|||||=|0.5|||||||t-test, 2 sided|||||||=0.5
73801615|NCT00611923|147152320|SUPERIORITY_OR_OTHER_LEGACY|paired t-test analysis comparing change from baseline CGI severity score at month 2 between flutamide and placebo groups|||||<|0.04|||||||t-test, 2 sided|||||||<.04
73801616|NCT00611923|147152321|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|||||||t-test, 2 sided|||paired t-test was performed comparing the Patient Global Improvement score at month 1 between placebo and flutamide groups||||=0.2
73801617|NCT00611923|147152321|SUPERIORITY_OR_OTHER_LEGACY|paired t-test was performed comparing the Patient Globall Improvement score at treatment month 2 between placebo and flutamide groups|||||=|0.06|||||||t-test, 2 sided|||||||=0.06
73801618|NCT00838903|147152322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|||||TWO_SIDED|95.0|-1.16|-0.65|||ANCOVA|||||-0.65|-1.16|
73801619|NCT00838903|147152322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.53|-0.17|||ANCOVA|||||-0.17|-0.53|
73801620|NCT00838903|147152322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.45|-0.09|||ANCOVA|||||-0.09|-0.45|
73801621|NCT00838903|147152322|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value is for superiority testing of albiglutide over placebo at 0.05 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - placebo) is equal to zero||||||<0.0001
73801622|NCT00838903|147152322|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - sitagliptin) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus sitagliptin at 0.0125 level.|t-test, 1 sided|||||||<0.0001
73801623|NCT00838903|147152322|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - glimepiride) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus glimepiride at 0.0125 level.|t-test, 1 sided|||||||<0.0001
73801624|NCT00838903|147152322|SUPERIORITY_OR_OTHER|||||||0.0001||||||The p-value is for superiority testing of albiglutide versus sitagliptin at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - sitagliptin) is equal to zero.||||||0.0001
73801625|NCT00838903|147152322|SUPERIORITY_OR_OTHER|||||||0.0033||||||The p-value is for superiority testing of albiglutide versus glimepiride at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - glimepiride) is equal to zero.||||||0.0033
73801626|NCT02549859|147152349|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
73801627|NCT02549859|147152350|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
73801628|NCT02549859|147152351|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
73801629|NCT02549859|147152352|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
73801630|NCT02549859|147152353|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
73801631|NCT02549859|147152354|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
73801632|NCT02549859|147152355|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
73801633|NCT02549859|147152356|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
73801634|NCT02549859|147152357|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
73801635|NCT02549859|147152358|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
73801636|NCT02549859|147152359|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
73801637|NCT02549859|147152360|SUPERIORITY||||||<|0.001|||||||Paired t-test, 2 sided|||||||<0.001
73801638|NCT02549859|147152361|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
73801639|NCT02549859|147152362|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
73801640|NCT02549859|147152363|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
73801641|NCT02549859|147152364|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
73801642|NCT02549859|147152365|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
73801643|NCT02549859|147152366|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
73801644|NCT02549859|147152367|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
73801645|NCT02549859|147152368|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
73801646|NCT03003962|147152375|OTHER|"The analysis was performed using the stratified log-rank test, adjusting for PD-L1 expression (TC 25% to 49% versus \>= 50%) and histology and smoking status (squamous vs. non-squamous + never smoker vs.~non-squamous + former/current smoker) and using the rank tests of association approach."|Hazard Ratio (HR)|0.84||||0.037|TWO_SIDED|95.0|0.706|0.989|||Stratified Log-rank test||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model|||0.989|0.706|0.037
73801647|NCT03003962|147152376|OTHER|"The analysis was performed using the stratified log-rank test, adjusting for PD-L1 expression (TC 25% to 49% versus \>= 50%) and histology and smoking status (squamous vs. non-squamous + never smoker vs.~non-squamous + former/current smoker) and using the rank tests of association approach."|Hazard Ratio (HR)|0.96||||0.628|TWO_SIDED|95.0|0.793|1.151|||Stratified log-rank test||The HR and CI were calculated using a stratified Cox proportional hazards model.|||1.151|0.793|0.628
73801648|NCT04616612|147152476|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
73801649|NCT04616612|147152477|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||.04
73801650|NCT04616612|147152478|OTHER||||||||||||||||||"Qualitative data evaluated from interviews tailored after the acceptability scale questionnaire. These interview questions specifically asked participant to rate from strongly disagree to strongly agree on each question and then rationalize answers.~Mobile support: 77% of participants agreed that mobile messages supported their health behaviors.~Time required: 85% disagreed that the intervention took too much time to learn.~Program effectiveness: 92% enjoyed this learning approach, with 100% agreeing they could use the information to improve health behaviors.~Rationalization feedback found participants in rural areas reported difficulties accessing texts."|||
73801651|NCT04616612|147152479|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
73801652|NCT04616612|147152480|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
73801653|NCT04616612|147152481|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
73801654|NCT04616612|147152482|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
73801655|NCT04616612|147152483|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||.84
73801656|NCT04616612|147152484|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||0.84
73801657|NCT04740918|147152485|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (estrogen receptors (ER) and/or progesterone receptor (PgR) positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the Hazard Ratio (HR).|Hazard Ratio (HR)|0.75||||0.2876|TWO_SIDED|95.0|0.44|1.28|||Log Rank|||||1.28|0.44|0.2876
73801658|NCT04740918|147152486|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.59||||0.5151|TWO_SIDED|95.0|0.39|6.43|||Log Rank|||||6.43|0.39|0.5151
73801659|NCT04740918|147152487|SUPERIORITY|A Cochran-Mantel-Haenszel chi-square test, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis), was used to test for difference in response rates.|Odds Ratio (OR)|1.16||||0.724|TWO_SIDED|95.0|0.5|2.7|||Cochran-Mantel-Haenszel|||||2.70|0.50|0.7240
73801660|NCT04740918|147152488|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|0.65||||0.3531|TWO_SIDED|95.0|0.26|1.61|||Log Rank|||||1.61|0.26|0.3531
73801661|NCT04740918|147152489|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.35||||0.7175|TWO_SIDED|95.0|0.27|6.81|||Log Rank|||||6.81|0.27|0.7175
73801662|NCT04740918|147152490|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.||||||0.3173|||||||Log Rank|||||||0.3173
73801663|NCT04740918|147152491|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.19||||0.8658|TWO_SIDED|95.0|0.16|8.6|||Log Rank|||||8.60|0.16|0.8658
73801664|NCT04740918|147152492|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.16||||0.8407|TWO_SIDED|95.0|0.27|4.99|||Log Rank|||||4.99|0.27|0.8407
73801665|NCT02524847|147152502|OTHER||Overall response rate (%)|55.2|||<|0.001|TWO_SIDED|95.0|35.7|73.6|||t-test, 2 sided|2-sided p-value for testing the null hypothesis H0: Standard therapy has a CR+PR rate = 10% after 4 weeks, using the exact Binomial test.||||73.6|35.7|<.001
73801666|NCT01288079|147152524|SUPERIORITY_OR_OTHER||LS mean|-1.5|STANDARD_ERROR_OF_MEAN|2.95||0.617|TWO_SIDED|95.0|-7.35|4.39|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||4.39|-7.35|0.617
73801667|NCT01288079|147152524|SUPERIORITY_OR_OTHER||LS mean|-3.6|STANDARD_ERROR_OF_MEAN|3.26||0.277|TWO_SIDED|95.0|-10.06|2.91|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||2.91|-10.06|0.277
73801668|NCT01288079|147152524|SUPERIORITY_OR_OTHER||LS mean|-3.9|STANDARD_ERROR_OF_MEAN|2.95||0.194|TWO_SIDED|95.0|-9.72|2.0|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||2.00|-9.72|0.194
73801669|NCT03170544|147152528|OTHER||Mean|1.33|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|0.63|2.04|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).|2.04|0.63|
73801670|NCT03170544|147152528|OTHER||Mean|2.74|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|2.03|3.44|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).|3.44|2.03|
73801671|NCT02387840|147152553|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.0002
73801672|NCT02387840|147152553|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.0003
73801673|NCT02387840|147152554|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.081|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.081
73801674|NCT02387840|147152554|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.081|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.081
73801675|NCT02387840|147152555|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.12
73801676|NCT02387840|147152555|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.14
73801677|NCT03477006|147152557|SUPERIORITY|||||||0.91|||||||Chi-squared|||||||0.91
73801678|NCT03477006|147152558|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
73801679|NCT03477006|147152559|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
73801680|NCT02174627|147152560|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% confidence interval (CI) of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|0.041|<|0.001|TWO_SIDED|95.0|1.27|1.43|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.||1.43|1.27|<0.001
73801681|NCT02174627|147152561|SUPERIORITY||Relative Risk|9.12|||<|0.001|TWO_SIDED|95.0|7.63|10.89|||Cochran-Mantel-Haenszel|||Comparison of the percentage of responders for roxadustat versus placebo was analysed using a Cochran-Mantel-Haenszel test adjusting for baseline Hb, baseline eGFR, geographic region and CV history.||10.89|7.63|<0.001
73801682|NCT02174627|147152562|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|0.91|1.35|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.||1.35|0.91|<0.001
73801683|NCT02174627|147152563|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.47|0.52|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||0.52|0.47|<0.001
73801684|NCT02174627|147152564|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.4|0.45|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||0.45|0.40|<0.001
73801685|NCT02174627|147152565|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.033|<|0.001|TWO_SIDED|95.0|-0.42|-0.29|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||-0.29|-0.42|<0.001
73801686|NCT02174627|147152566|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.26|||<|0.001|TWO_SIDED|95.0|0.23|0.31|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.||0.31|0.23|<0.001
73801687|NCT02174627|147152567|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.3|0.44|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.||0.44|0.30|<0.001
73801688|NCT02174627|147152568|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.283||0.12|TWO_SIDED|95.0|-0.11|0.99|||Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.||0.99|-0.11|0.120
73801689|NCT02174627|147152569|OTHER||Rate of Change Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.254||0.046|TWO_SIDED|95.0|-1.0|-0.01||Nominal p-value (as prior sequential outcome measure p-value did not meet \< 0.05.|Random Effects Analysis|||Difference between groups (roxadustat minus placebo) in rate of change in eGFR; random effects analysis.||-0.01|-1.00|0.046
73801690|NCT02174627|147152570|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.269||0.051|TWO_SIDED|95.0|0.0|1.05||Nominal p-value (as prior sequential outcome measure p-value did not meet \< 0.05.|Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.||1.05|0.00|0.051
73801691|NCT00071110|147152604|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Statistic (t): -1.00|t-test, 2 sided|||||||0.32
73801692|NCT00071110|147152605|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||Statistic (t): 1.56|t-test, 2 sided|||||||0.09
73801693|NCT00071110|147152606|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||Statistic (t): 1.40|t-test, 2 sided|||||||0.17
73801694|NCT02259010|147152628|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|0.98|||||TWO_SIDED|90.0|0.82|1.19|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.19|0.82|
73801695|NCT02259010|147152629|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|1.35|||||TWO_SIDED|90.0|1.02|1.79|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.79|1.02|
73801696|NCT02259010|147152630|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|1.39|||||TWO_SIDED|90.0|0.99|1.95|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.95|0.99|
73801697|NCT03578367|147152641|OTHER|No test performed|Risk Difference (RD)|19.5|||||TWO_SIDED|90.0|5.0|33.1||||||||33.1|5.0|
73801698|NCT03578367|147152641|OTHER|No test performed|Risk Difference (RD)|28.57|||||TWO_SIDED|90.0|12.4|44.8||||||||44.8|12.4|
73801699|NCT03578367|147152642|OTHER|No test performed|Risk Difference (RD)|14.29|||||TWO_SIDED|90.0|-1.7|30.3||||||||30.3|-1.7|
73801700|NCT03578367|147152642|OTHER|No test performed|Risk Difference (RD)|23.81|||||TWO_SIDED|90.0|5.9|41.7||||||||41.7|5.9|
73801701|NCT01267019|147152660|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||This is a statistical analysis to determine the training effect of social cognitive skills training (in vivo and social cog versus control).||||< .05
73801702|NCT01267019|147152661|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
73801703|NCT01267019|147152662|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
73801704|NCT02729025|147152663|SUPERIORITY||LS Mean Treatment Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24||0.18|TWO_SIDED|95.0|-7.4|1.39|||Multivariate regression model||Treatment difference used placebo as the reference|A multivariate regression was modelled on the primary endpoint as well as three other response variables (percent change in Lp\[a\] at Weeks 8 and 16, baseline MDS TBR, and baseline Lp\[a\]). The primary endpoint was regressed on the treatment group and statin stratification factor; baseline MDS TBR and Lp(a) were regressed on the statin stratification factor, and percent changes in Lp(a) were regressed on the treatment group, statin stratification factor, visit, and treatment group by visit.||1.39|-7.40|0.18
73801705|NCT02729025|147152664|SUPERIORITY||LS Mean Treatment Difference|-13.89|STANDARD_ERROR_OF_MEAN|2.73|<|0.0001|TWO_SIDED|95.0|-19.29|-8.49|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-8.49|-19.29|<0.0001
73801706|NCT02729025|147152665|SUPERIORITY||LS Mean Treatment Difference|-60.66|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|-65.81|-55.51|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-55.51|-65.81|<0.0001
73801707|NCT02729025|147152666|SUPERIORITY||LS Mean Treatment Difference|-51.29|STANDARD_ERROR_OF_MEAN|2.15|<|0.0001|TWO_SIDED|95.0|-55.85|-47.33|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-47.33|-55.85|<0.0001
73801708|NCT04242446|147152667|SUPERIORITY||Odds Ratio (OR)|2.0||||0.03|TWO_SIDED|97.5|0.979|4.089|||Regression, Logistic|||||4.089|0.979|0.030
73801709|NCT04242446|147152667|SUPERIORITY||Odds Ratio (OR)|2.234||||0.006|TWO_SIDED|97.5|1.159|4.307|||Regression, Logistic|||||4.307|1.159|0.006
73801710|NCT04242446|147152668|SUPERIORITY||Odds Ratio (OR)|1.416||||0.35|TWO_SIDED|97.5|0.615|3.26||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|Regression, Logistic|||||3.260|0.615|0.350
73801711|NCT04242446|147152668|SUPERIORITY||Odds Ratio (OR)|2.175||||0.021|TWO_SIDED|97.5|1.021|4.635|||Regression, Logistic|||||4.635|1.021|0.021
73801712|NCT04242446|147152669|SUPERIORITY||LS mean difference|-2.574||||0.002|TWO_SIDED|97.5|-4.472|-0.675||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|ANCOVA|||||-0.675|-4.472|0.002
73801713|NCT04242446|147152669|SUPERIORITY||LS mean difference|-2.682|||<|0.001|TWO_SIDED|97.5|-4.394|-0.97|||ANCOVA|||||-0.970|-4.394|<0.001
73801714|NCT04242446|147152670|SUPERIORITY||LS mean difference|-0.551||||0.201|TWO_SIDED|97.5|-1.521|0.418||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|ANCOVA|||||0.418|-1.521|0.201
73801715|NCT04242446|147152670|SUPERIORITY||LS mean difference|-1.186||||0.002|TWO_SIDED|97.5|-2.05|-0.322|||ANCOVA|||||-0.322|-2.050|0.002
73801716|NCT04242446|147152671|SUPERIORITY||Odds Ratio (OR)|1.618||||0.367|TWO_SIDED|97.5|0.489|5.352||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|Regression, Logistic|||||5.352|0.489|0.367
73801717|NCT04242446|147152671|SUPERIORITY||Odds Ratio (OR)|2.757||||0.041|TWO_SIDED|97.5|0.909|8.364|||Regression, Logistic|||||8.364|0.909|0.041
73801718|NCT03349060|147152699|SUPERIORITY||Difference in Percentage|15.8||||0.0037|TWO_SIDED|95.0|6.8|24.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.8|6.8|0.0037
73801719|NCT03349060|147152699|SUPERIORITY||Difference in Percentage|36.0|||<|0.0001|TWO_SIDED|95.0|26.2|45.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.7|26.2|<0.0001
73801720|NCT03349060|147152700|SUPERIORITY||Difference in Percentage|27.9|||<|0.0001|TWO_SIDED|95.0|17.4|38.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.3|17.4|<0.0001
73801721|NCT03349060|147152700|SUPERIORITY||Difference in Percentage|51.0|||<|0.0001|TWO_SIDED|95.0|40.5|61.5|||Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||61.5|40.5|<0.0001
73801722|NCT03349060|147152701|SUPERIORITY||Difference in Percentage|18.0||||0.0004|TWO_SIDED|95.0|10.2|25.8|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the Cochran-Mantel-Haenszel (CMH) risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||25.8|10.2|0.0004
73801723|NCT03349060|147152701|SUPERIORITY||Difference in Percentage|42.5|||<|0.0001|TWO_SIDED|95.0|33.6|51.4|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||51.4|33.6|<0.0001
73801724|NCT03349060|147152701|SUPERIORITY||Difference in Percentage|15.0||||0.0251|TWO_SIDED|95.0|1.9|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||28.0|1.9|0.0251
73894423|NCT01818752|147321407|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.1388|TWO_SIDED|95.0|0.875|1.589||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.589|0.875|0.1388
73801725|NCT03349060|147152701|SUPERIORITY||Difference in Percentage|41.1|||<|0.0001|TWO_SIDED|95.0|27.8|54.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||54.4|27.8|<0.0001
73801726|NCT03349060|147152701|SUPERIORITY||Difference in Percentage|20.0||||0.0019|TWO_SIDED|95.0|7.4|32.7|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||32.7|7.4|0.0019
73801727|NCT03349060|147152701|SUPERIORITY||Difference in Percentage|45.3|||<|0.0001|TWO_SIDED|95.0|32.7|57.8|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||57.8|32.7|<0.0001
73801728|NCT03349060|147152701|SUPERIORITY||Difference in Percentage|22.5||||0.0003|TWO_SIDED|95.0|10.3|34.8|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||34.8|10.3|0.0003
73801729|NCT03349060|147152701|SUPERIORITY||Difference in Percentage|41.7|||<|0.0001|TWO_SIDED|95.0|29.6|53.9|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||53.9|29.6|<0.0001
73801730|NCT03349060|147152702|SUPERIORITY||Difference in Percentage|16.3||||0.0055|TWO_SIDED|95.0|7.4|25.2|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||25.2|7.4|0.0055
73801731|NCT03349060|147152702|SUPERIORITY||Difference in Percentage|43.3|||<|0.0001|TWO_SIDED|95.0|33.1|53.6|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||53.6|33.1|<0.0001
73801732|NCT03349060|147152702|SUPERIORITY||Difference in Percentage|12.5||||0.1138|TWO_SIDED|95.0|-3.0|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||28.0|-3.0|0.1138
73801733|NCT03349060|147152702|SUPERIORITY||Difference in Percentage|41.8|||<|0.0001|TWO_SIDED|95.0|26.2|57.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||57.4|26.2|<0.0001
73801734|NCT03349060|147152702|SUPERIORITY||Difference in Percentage|28.7|||<|0.0001|TWO_SIDED|95.0|15.3|42.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||42.1|15.3|<0.0001
73801735|NCT03349060|147152702|SUPERIORITY||Difference in Percentage|47.8|||<|0.0001|TWO_SIDED|95.0|34.6|61.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||61.1|34.6|<0.0001
73801736|NCT03349060|147152703|SUPERIORITY||Difference in least squares (LS) mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.4|<0.0001
73801737|NCT03349060|147152703|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.2|-2.0|<0.0001
73801738|NCT03349060|147152703|SUPERIORITY||Difference in LS mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.6|<0.0001
73801739|NCT03349060|147152703|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-2.8|<0.0001
73894424|NCT01818752|147321408|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.048|||<|0.0001|TWO_SIDED|95.0|0.026|0.088||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Pearson Chi-Square test||Unstratified odds ratio (Carfilzomib/Bortezomib) was estimated.|||0.088|0.026|< 0.0001
73894425|NCT01818752|147321409|SUPERIORITY_OR_OTHER||Least squares mean difference|4.99|STANDARD_ERROR_OF_MEAN|0.773|<|0.0001|TWO_SIDED|95.0|3.48|6.51||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Mixed Effects Model for Repeated Measure|||Treatment groups were compared using a linear mixed model for repeated measures (MMRM). The model included the fixed, categorical effects of treatment (all baseline responses were modeled with a dummy treatment), the randomization stratification factors - ISS stage, choice of route of bortezomib administration, region, age, and random effects of subject intercept and coefficient on time.||6.51|3.48|< 0.0001
73801740|NCT03349060|147152703|SUPERIORITY||Difference in LS mean|-0.9||||0.0035|TWO_SIDED|95.0|-1.5|-0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-1.5|0.0035
73894426|NCT04303195|147321458|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.479||0.135|TWO_SIDED|95.0|-1.67|0.23||The threshold for statistical significance was p = 0.05.|ANOVA|||||0.23|-1.67|0.1350
73894427|NCT04303195|147321458|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.493||0.0997|TWO_SIDED|95.0|-1.79|0.16||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.16|-1.79|0.0997
73801741|NCT03349060|147152703|SUPERIORITY||Difference in LS mean|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.3|-2.5|<0.0001
73801742|NCT03349060|147152703|SUPERIORITY||Difference in LS mean|-1.1||||0.001|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.7|0.0010
73801743|NCT03349060|147152703|SUPERIORITY||Difference in LS mean|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-2.7|<0.0001
73801744|NCT03349060|147152704|SUPERIORITY||Difference in LS mean|-1.3||||0.0002|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.0|0.0002
73801745|NCT03349060|147152704|SUPERIORITY||Difference in LS mean|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.6|-3.0|<0.0001
73801746|NCT03349060|147152705|SUPERIORITY|||||||0.0071||||||P-value was controlled by randomization strata.|Log Rank|||||||0.0071
73801747|NCT03349060|147152705|SUPERIORITY||||||<|0.0001||||||P-value was controlled by randomization strata.|Log Rank|||||||<0.0001
73801748|NCT03349060|147152706|SUPERIORITY||Difference in Percentage|6.5||||0.0869|TWO_SIDED|95.0|-0.3|13.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||13.3|-0.3|0.0869
73801749|NCT03349060|147152706|SUPERIORITY||Difference in Percentage|20.3||||0.0001|TWO_SIDED|95.0|12.0|28.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.6|12.0|0.0001
73801750|NCT03349060|147152706|SUPERIORITY||Difference in Percentage|13.1||||0.0259|TWO_SIDED|95.0|2.6|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.6|2.6|0.0259
73801751|NCT03349060|147152706|SUPERIORITY||Difference in Percentage|33.0|||<|0.0001|TWO_SIDED|95.0|21.7|44.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.2|21.7|<0.0001
73801752|NCT03349060|147152706|SUPERIORITY||Difference in Percentage|25.0||||0.0001|TWO_SIDED|95.0|14.2|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.8|14.2|0.0001
73801753|NCT03349060|147152706|SUPERIORITY||Difference in Percentage|44.6|||<|0.0001|TWO_SIDED|95.0|33.6|55.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.6|33.6|<0.0001
73894428|NCT04303195|147321458|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.492||0.2195|TWO_SIDED|95.0|-1.58|0.37||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.37|-1.58|0.2195
73894429|NCT04303195|147321459|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.498||0.7944|TWO_SIDED|95.0|-1.11|0.85||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.85|-1.11|0.7944
73894430|NCT04303195|147321459|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.51||0.4956|TWO_SIDED|95.0|-1.36|0.66||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.66|-1.36|0.4956
73894431|NCT04303195|147321459|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.511||0.626|TWO_SIDED|95.0|-0.76|1.26||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.26|-0.76|0.6260
73801754|NCT03349060|147152707|SUPERIORITY||Difference in Percentage|3.9||||0.0802|TWO_SIDED|95.0|-0.7|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.5|-0.7|0.0802
73801755|NCT03349060|147152707|SUPERIORITY||Difference in Percentage|9.8||||0.0045|TWO_SIDED|95.0|4.0|15.7||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.7|4.0|0.0045
73894432|NCT04303195|147321460|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.543||0.8866|TWO_SIDED|95.0|-1.15|1.0||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.00|-1.15|0.8866
73894433|NCT04303195|147321460|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.558||0.8699|TWO_SIDED|95.0|-1.19|1.01||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.01|-1.19|0.8699
73894434|NCT04303195|147321460|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.556||0.7297|TWO_SIDED|95.0|-0.91|1.29||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.29|-0.91|0.7297
73894435|NCT04303195|147321461|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.409||0.9034|TWO_SIDED|95.0|-0.76|0.86||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.86|-0.76|0.9034
73894436|NCT04303195|147321461|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.9742|TWO_SIDED|95.0|-0.68|0.63||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.63|-0.68|0.9742
73894437|NCT04303195|147321461|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.417||0.2235|TWO_SIDED|95.0|-0.31|1.33||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.33|-0.31|0.2235
73894438|NCT04303195|147321462|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.118||0.3567|TWO_SIDED|95.0|-0.34|0.12||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.12|-0.34|0.3567
73894439|NCT04303195|147321462|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1129|TWO_SIDED|95.0|-0.43|0.05||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.05|-0.43|0.1129
73894440|NCT04303195|147321462|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.459|TWO_SIDED|95.0|-0.33|0.15||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.15|-0.33|0.4590
73894441|NCT04303195|147321463|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.485||0.525|TWO_SIDED|95.0|-1.27|0.65||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.65|-1.27|0.5250
73801756|NCT03349060|147152707|SUPERIORITY||Difference in Percentage|5.2||||0.1888|TWO_SIDED|95.0|-1.9|12.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.4|-1.9|0.1888
73894442|NCT04303195|147321463|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.498||0.3991|TWO_SIDED|95.0|-1.41|0.56||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.56|-1.41|0.3991
73894443|NCT04303195|147321463|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.497||0.9006|TWO_SIDED|95.0|-1.05|0.92||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.92|-1.05|0.9006
73894444|NCT04303195|147321464|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.444||0.6009|TWO_SIDED|95.0|-1.11|0.64||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.64|-1.11|0.6009
73894445|NCT04303195|147321464|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.454||0.4654|TWO_SIDED|95.0|-1.23|0.56||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.56|-1.23|0.4654
73894446|NCT04303195|147321464|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.455||0.8842|TWO_SIDED|95.0|-0.83|0.97||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.97|-0.83|0.8842
73894447|NCT06457204|147321465|OTHER||Ratio of adjusted geometric means [%]|101.6|||||TWO_SIDED|90.0|98.4|105.0|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 6.9."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.0|98.4|
73894448|NCT06457204|147321466|OTHER||Ratio of adjusted geometric means [%]|98.3|||||TWO_SIDED|90.0|91.6|105.5|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 15.0."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.5|91.6|
73894449|NCT06457204|147321467|OTHER||Ratio of adjusted geometric means [%]|101.6|||||TWO_SIDED|90.0|98.2|105.0|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.1."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.0|98.2|
73894450|NCT01065454|147321468|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-2.71||||0.1044|TWO_SIDED|95.0|-5.99|0.057||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||0.057|-5.99|0.1044
73894451|NCT01065454|147321468|SUPERIORITY_OR_OTHER_LEGACY||LSMEANS Difference|-1.38||||0.5292|TWO_SIDED|95.0|-5.71|2.94||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||2.94|-5.71|0.5292
73894452|NCT01065454|147321468|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-4.51||||0.0278|TWO_SIDED|95.0|-8.52|-0.5||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||-0.50|-8.52|0.0278
73894453|NCT01065454|147321468|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|1.8||||0.3821|TWO_SIDED|95.0|-2.25|5.84||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||5.84|-2.25|0.3821
73894454|NCT01065454|147321468|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|3.13||||0.2084|TWO_SIDED|95.0|-1.76|8.02||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||8.02|-1.76|0.2084
73894455|NCT01065454|147321468|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-1.33||||0.5442|TWO_SIDED|95.0|-5.66|3.0||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||3.00|-5.66|0.5442
73894456|NCT01065454|147321469|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|1.87|||||TWO_SIDED|95.0|-0.83|4.56||||||||4.56|-0.83|
73894457|NCT01065454|147321469|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.2|||||TWO_SIDED|95.0|-3.12|3.51||||||||3.51|-3.12|
73894458|NCT01065454|147321469|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.23|||||TWO_SIDED|95.0|-3.31|3.77||||||||3.77|-3.31|
73894459|NCT01065454|147321470|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-46.59|||||TWO_SIDED|95.0|-89.4|-3.8||||||||-3.8|-89.4|
73894460|NCT01065454|147321470|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-32.26|||||TWO_SIDED|95.0|-84.9|20.4||||||||20.4|-84.9|
73894461|NCT01065454|147321470|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-26.52|||||TWO_SIDED|95.0|-83.0|30.0||||||||30.0|-83.0|
73894462|NCT01065454|147321471|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-89.17|||||TWO_SIDED|95.0|-172.9|5.5||||||||5.5|-172.9|
73894463|NCT01065454|147321471|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-58.22|||||TWO_SIDED|95.0|-162.1|45.6||||||||45.6|-162.1|
73894464|NCT01065454|147321471|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-43.22|||||TWO_SIDED|95.0|-153.7|67.1||||||||67.1|-153.7|
73894465|NCT01065454|147321472|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-239.31|||||TWO_SIDED|95.0|-363.4|-115.3||||||||-115.3|-363.4|
73894466|NCT01065454|147321472|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-120.89|||||TWO_SIDED|95.0|-274.4|32.6||||||||32.6|-274.4|
73894467|NCT01065454|147321472|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-25.54|||||TWO_SIDED|95.0|-189.3|138.2||||||||138.2|-189.3|
73894468|NCT01065454|147321473|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-446.49|||||TWO_SIDED|95.0|-687.4|-205.6||||||||-205.6|-687.4|
73894469|NCT01065454|147321473|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-231.57|||||TWO_SIDED|95.0|-530.4|67.2||||||||67.2|-530.4|
73894470|NCT01065454|147321473|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-34.97|||||TWO_SIDED|95.0|-353.7|283.7||||||||283.7|-353.7|
73894471|NCT01065454|147321474|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-1.27|||||TWO_SIDED|95.0|-3.1|0.5||||||||0.5|-3.1|
73894472|NCT01065454|147321474|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.88|||||TWO_SIDED|95.0|-3.1|1.3||||||||1.3|-3.1|
73894473|NCT01065454|147321474|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.84|||||TWO_SIDED|95.0|-3.2|1.5||||||||1.5|-3.2|
73894474|NCT01065454|147321475|SUPERIORITY_OR_OTHER_LEGACY||LSS-MEANS Difference|-2.07|||||TWO_SIDED|95.0|-5.0|0.8||||||||0.8|-5.0|
73894475|NCT01065454|147321475|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS|1.39|||||TWO_SIDED|95.0|-2.1|4.9||||||||4.9|-2.1|
73894476|NCT01065454|147321475|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|-1.13|||||TWO_SIDED|95.0|-4.9|2.7||||||||2.7|-4.9|
73894477|NCT01065454|147321476|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.28|||||TWO_SIDED|95.0|-0.58|1.14||||||||1.14|-0.58|
73894478|NCT01065454|147321476|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.82|||||TWO_SIDED|95.0|-0.23|1.87||||||||1.87|-0.23|
73894479|NCT01065454|147321476|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.03|||||TWO_SIDED|95.0|-1.11|1.06||||||||1.06|-1.11|
73894480|NCT01065454|147321477|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-3.84|||||TWO_SIDED|95.0|-8.76|1.09||||||||1.09|-8.76|
73894481|NCT01065454|147321477|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANs Difference|-0.02|||||TWO_SIDED|95.0|-6.05|6.01||||||||6.01|-6.05|
73894482|NCT01065454|147321477|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-2.43|||||TWO_SIDED|95.0|-8.93|4.06||||||||4.06|-8.93|
73894483|NCT01065454|147321478|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.51|||||TWO_SIDED|95.0|-0.21|1.24||||||||1.24|-0.21|
73894484|NCT01065454|147321478|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|0.81|||||TWO_SIDED|95.0|-0.07|1.69||||||||1.69|-0.07|
73894485|NCT01065454|147321478|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.2|||||TWO_SIDED|95.0|-0.74|1.15||||||||1.15|-0.74|
73894486|NCT01065454|147321479|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-5.06|||||TWO_SIDED|95.0|-17.33|7.22||||||||7.22|-17.33|
73894487|NCT01065454|147321479|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.28|||||TWO_SIDED|95.0|-14.55|15.11||||||||15.11|-14.55|
73894488|NCT01065454|147321479|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-5.18|||||TWO_SIDED|95.0|-21.05|10.69||||||||10.69|-21.05|
73894489|NCT01065454|147321480|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|-4.27|||||TWO_SIDED|95.0|-21.13|12.6||||||||12.60|-21.13|
73894490|NCT01065454|147321480|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|2.78|||||TWO_SIDED|95.0|-17.59|23.16||||||||23.16|-17.59|
73894491|NCT01065454|147321480|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-4.61|||||TWO_SIDED|95.0|-26.43|17.2||||||||17.20|-26.43|
73894492|NCT01065454|147321481|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|5.29|||||TWO_SIDED|95.0|-7.38|17.95||||||||17.95|-7.38|
73894493|NCT01065454|147321481|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|6.47|||||TWO_SIDED|95.0|-9.79|22.73||||||||22.73|-9.79|
73894494|NCT01065454|147321481|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|10.35|||||TWO_SIDED|95.0|-6.14|26.84||||||||26.84|-6.14|
73894495|NCT01065454|147321482|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.15|||||TWO_SIDED|95.0|-0.55|0.24||||||||0.24|-0.55|
73894496|NCT01065454|147321482|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.17|||||TWO_SIDED|95.0|-0.34|0.67||||||||0.67|-0.34|
73894497|NCT01065454|147321482|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.06|||||TWO_SIDED|95.0|-0.45|0.56||||||||0.56|-0.45|
73894498|NCT01065454|147321483|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|10.17|||||TWO_SIDED|95.0|-18.48|38.81||||||||38.81|-18.48|
73894499|NCT01065454|147321483|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|7.92|||||TWO_SIDED|95.0|-26.76|42.59||||||||42.59|-26.76|
73894500|NCT01065454|147321483|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.15|||||TWO_SIDED|95.0|-44.08|31.78||||||||31.78|-44.08|
73894501|NCT01065454|147321485|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.62|||||TWO_SIDED|95.0|-13.36|14.61||||||||14.61|-13.36|
73894502|NCT01065454|147321485|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-9.46|||||TWO_SIDED|95.0|-24.32|5.39||||||||5.39|-24.32|
73894503|NCT01065454|147321485|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-6.07|||||TWO_SIDED|95.0|-22.26|10.13||||||||10.13|-22.26|
73894504|NCT01065454|147321487|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.03|||||TWO_SIDED|95.0|-0.04|0.1||||||||0.10|-0.04|
73894505|NCT01065454|147321487|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.01|||||TWO_SIDED|95.0|-0.07|0.09||||||||0.09|-0.07|
73894506|NCT01065454|147321487|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.02|||||TWO_SIDED|95.0|-0.07|0.11||||||||0.11|-0.07|
73894507|NCT01065454|147321488|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.8|||||TWO_SIDED|95.0|-12.81|-0.78||||||||-0.78|-12.81|
73894508|NCT01065454|147321488|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.81|||||TWO_SIDED|95.0|-13.96|0.35||||||||0.35|-13.96|
73894509|NCT01065454|147321488|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-7.5|||||TWO_SIDED|95.0|-15.29|0.28||||||||0.28|-15.29|
73894510|NCT01065454|147321489|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-24.62|||||TWO_SIDED|95.0|-117.58|68.33||||||||68.33|-117.58|
73894511|NCT01065454|147321489|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-53.29|||||TWO_SIDED|95.0|-162.46|55.88||||||||55.88|-162.46|
73801757|NCT03349060|147152707|SUPERIORITY||Difference in Percentage|21.7|||<|0.0001|TWO_SIDED|95.0|13.0|30.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.5|13.0|<0.0001
73894512|NCT01065454|147321489|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-8.36|||||TWO_SIDED|95.0|-135.78|119.06||||||||119.06|-135.78|
73894513|NCT01065454|147321490|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-407.34|||||TWO_SIDED|95.0|-1055.23|240.54||||||||240.54|-1055.23|
73894514|NCT01065454|147321490|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-447.26|||||TWO_SIDED|95.0|-1212.74|318.22||||||||318.22|-1212.74|
73894515|NCT01065454|147321490|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-517.48|||||TWO_SIDED|95.0|-1369.48|334.53||||||||334.53|-1369.48|
73894516|NCT01065454|147321491|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.01||||||||0.01|-0.01|
73894517|NCT01065454|147321491|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.01|||||TWO_SIDED|95.0|-0.02|0.0||||||||0.00|-0.02|
73894518|NCT01065454|147321491|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.01|||||TWO_SIDED|95.0|-0.02|0.01||||||||0.01|-0.02|
73894519|NCT01065454|147321492|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.04|0.03||||||||0.03|-0.04|
73894520|NCT01065454|147321492|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.04|0.05||||||||0.05|-0.04|
73894521|NCT01065454|147321492|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.02|||||TWO_SIDED|95.0|-0.07|0.03||||||||0.03|-0.07|
73894522|NCT01065454|147321493|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANSA Difference|-14.13|||||TWO_SIDED|95.0|-30.79|2.53||||||||2.53|-30.79|
73894523|NCT01065454|147321493|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-12.73|||||TWO_SIDED|95.0|-32.89|7.43||||||||7.43|-32.89|
73894524|NCT01065454|147321493|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-18.27|||||TWO_SIDED|95.0|-41.53|5.0||||||||5.00|-41.53|
73894525|NCT03583385|147321546|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|103.42|||||TWO_SIDED|90.0|95.18|112.37||||||||112.37|95.18|
73894526|NCT03583385|147321547|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|106.78|||||TWO_SIDED|90.0|98.99|115.19||||||||115.19|98.99|
73894527|NCT04780919|147321552|SUPERIORITY|||||||0.722||||||p-value is adjusted to comparison between the Group A and Group B at 3 weeks follow-up after the last application.|Two-way ANOVA|||The Group A will have significantly decreased Cross Section Area compared to Group B at 3 weeks follow up after last application.||||0.722
73894528|NCT04780919|147321553|SUPERIORITY|||||||0.096||||||p-value is adjusted to comparison between the Group A and Group B in the timeframe of the last application.|Two-way ANOVA|||The maximum pain will decrease significantly more in Group A compared to Group B in the timeframe of the last application compared to baseline.||||0.096
73894529|NCT04780919|147321554|SUPERIORITY|||||||0.035||||||p-value is adjusted to comparison between the Group A and Group B at the 3 weeks follow up compared to baseline.|Two-way ANOVA|||The maximum pain will decrease significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.035
73894530|NCT04780919|147321555|SUPERIORITY|||||||0.171||||||p-value is adjusted to comparison between the Group A and Group B at the 3 weeks follow up compared to baseline.|Two-way ANOVA|||The maximum of ankle dorsiflexion range of motion will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.171
73894531|NCT04780919|147321558|SUPERIORITY|||||||0.104||||||p-value is adjusted to comparison between the Group A and Group B in 3 weeks follow up after the last application.|Two-way ANOVA|||The VISA-A score will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.104
73894532|NCT01523275|147321586|EQUIVALENCE|Analysis of 44 subjects (22 in each arm) would provide 90% power to detect a difference in the time interval to reoperation of 6 months between the two treatment arms, at an alpha level of 0.05. This difference of 6 months is clinically meaningful and is smaller than previous case series studies would suggest. However, due to poor patient accrual, the study was closed prior to reaching the desired study size.||||||0.95|||||||t-test, 2 sided|||||||0.95
73894533|NCT01523275|147321587|EQUIVALENCE|A difference of 6 months to symptom progression is clinically meaningful.||||||0.52|||||||t-test, 2 sided|||||||0.52
73894534|NCT01523275|147321588|EQUIVALENCE|0.5 liters per second is clinically significant.||||||0.64|||||||t-test, 2 sided|||||||0.64
73894535|NCT00332722|147321597|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired t test|||||||<0.05
73894536|NCT00332722|147321598|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired t test|||||||<0.05
73801758|NCT03349060|147152707|SUPERIORITY||Difference in Percentage|13.8||||0.0071|TWO_SIDED|95.0|5.2|22.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||22.4|5.2|0.0071
73801759|NCT03349060|147152707|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|19.8|38.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.7|19.8|<0.0001
73801760|NCT03349060|147152708|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with event was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
73801761|NCT03349060|147152708|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with event was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
73801762|NCT03349060|147152708|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.9|3.9||P-value could not be calculated since percentage of participants with event was 0.||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.9|-3.9|
73894537|NCT00918736|147321599|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Previous report using 5 weekly injections, mean AOS score reduction is 2.6 with the SD of 1.8 in 75 patients. To test whether AOS reduction would be \> 1 using pair t-test after 3 weekly injections, investigators need \> 42 patients to give \> 90% power to reject the null hypothesis-mean AOS score reduction \<1 at 6 months, given that both the mean and standard deviation of AOS score reduction equal to 2. Considering possible dropout of participants, investigators decide to include 50 patients||||<0.05
73801763|NCT03349060|147152708|SUPERIORITY||Difference in Percentage|6.5||||0.0234|TWO_SIDED|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|1.3|0.0234
73801764|NCT03349060|147152708|SUPERIORITY||Difference in Percentage|4.6||||0.0592|TWO_SIDED|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.5|-0.3|0.0592
73801765|NCT03349060|147152708|SUPERIORITY||Difference in Percentage|11.7||||0.0022|TWO_SIDED|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|5.5|0.0022
73801766|NCT03349060|147152708|SUPERIORITY||Difference in Percentage|7.0||||0.019|TWO_SIDED|95.0|1.7|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.3|1.7|0.0190
73801767|NCT03349060|147152708|SUPERIORITY||Difference in Percentage|13.1||||0.001|TWO_SIDED|95.0|6.7|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.7|0.0010
73801768|NCT03349060|147152709|SUPERIORITY||Difference in Percentage|24.0|||<|0.0001|TWO_SIDED|95.0|13.9|34.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.1|13.9|<0.0001
73801769|NCT03349060|147152709|SUPERIORITY||Difference in Percentage|45.1|||<|0.0001|TWO_SIDED|95.0|34.7|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.5|34.7|<0.0001
73801770|NCT03349060|147152709|SUPERIORITY||Difference in Percentage|33.5|||<|0.0001|TWO_SIDED|95.0|21.6|45.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.4|21.6|<0.0001
73894538|NCT03462511|147321619|SUPERIORITY||Mean Difference (Net)|2.4||||0.067|TWO_SIDED|||||Independent variables: study month, study group, their interactions and a person-level random intercept to incorporate clustering.|Regression, Linear|||Based on estimated effect size from our prior feasibility trial, the target enrollment was 87 dyads plus additional 20% to account for attrition before Month 6 or blood transfusions or acute illness rendering HbF levels inaccurate.||||0.067
73894539|NCT03462511|147321620|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||We compared the difference in proportion of days covered by hydroxyurea at two timepoints: (1) from the year prior to study entry to 6 months (the end of the active intervention phase of the trial) and (2) from 6 months to 12 months (the sustainability phase of the trial).||||0.60
73894540|NCT03462511|147321621|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||We hypothesized that, compared to the control group, generic quality of life (QOL) for youth in the intervention group would improve from baseline to 9 months.||||<0.001
73801771|NCT03349060|147152709|SUPERIORITY||Difference in Percentage|52.7|||<|0.0001|TWO_SIDED|95.0|41.2|64.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||64.2|41.2|<0.0001
73801772|NCT03349060|147152709|SUPERIORITY||Difference in Percentage|34.1|||<|0.0001|TWO_SIDED|95.0|21.9|46.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.3|21.9|<0.0001
73801773|NCT03349060|147152709|SUPERIORITY||Difference in Percentage|52.9|||<|0.0001|TWO_SIDED|95.0|41.3|64.6|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||64.6|41.3|<0.0001
73801774|NCT03349060|147152709|SUPERIORITY||Difference in Percentage|35.3|||<|0.0001|TWO_SIDED|95.0|23.3|47.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.4|23.3|<0.0001
73801775|NCT03349060|147152709|SUPERIORITY||Difference in Percentage|53.5|||<|0.0001|TWO_SIDED|95.0|42.0|65.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||65.0|42.0|<0.0001
73801776|NCT03349060|147152710|SUPERIORITY||Difference in Percentage|0.6||||0.7285|TWO_SIDED|95.0|-3.9|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-3.9|0.7285
73801777|NCT03349060|147152710|SUPERIORITY||Difference in Percentage|4.0||||0.1448|TWO_SIDED|95.0|-1.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-1.2|0.1448
73801778|NCT03349060|147152710|SUPERIORITY||Difference in Percentage|3.9||||0.2576|TWO_SIDED|95.0|-2.6|10.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.5|-2.6|0.2576
73801779|NCT03349060|147152710|SUPERIORITY||Difference in Percentage|20.4||||0.0001|TWO_SIDED|95.0|12.0|28.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.9|12.0|0.0001
73801780|NCT03349060|147152710|SUPERIORITY||Difference in Percentage|9.0||||0.0423|TWO_SIDED|95.0|1.3|16.8|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.8|1.3|0.0423
73801781|NCT03349060|147152710|SUPERIORITY||Difference in Percentage|28.0|||<|0.0001|TWO_SIDED|95.0|18.7|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.2|18.7|<0.0001
73801782|NCT03349060|147152710|SUPERIORITY||Difference in Percentage|13.3||||0.0066|TWO_SIDED|95.0|5.4|21.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.2|5.4|0.0066
73801783|NCT03349060|147152710|SUPERIORITY||Difference in Percentage|33.4|||<|0.0001|TWO_SIDED|95.0|24.3|42.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.5|24.3|<0.0001
73801784|NCT03349060|147152711|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
73801785|NCT03349060|147152711|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
73801786|NCT03349060|147152711|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.9|3.9||P-value could not be calculated since percentage of participants with events was 0.||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.9|-3.9|
73801787|NCT03349060|147152711|SUPERIORITY||Difference in Percentage|6.5||||0.0234|TWO_SIDED|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|1.3|0.0234
73894541|NCT03462511|147321621|NON_INFERIORITY|30% of the standard deviation was used as the non-inferiority margin. For this test generic quality of life (QOL) scores for months 4-9 (efficacy period) were compared to months \>9 (sustainability period).||||||0.04|||||||Regression, Linear|||We hypothesized that the improvement in quality of life experienced by the intervention group would be sustained from month 9 to month 12.||||0.04
73894542|NCT03462511|147321622|SUPERIORITY|||||||0.47|||||||Regression, Linear|||We hypothesized that, compared to the control group, sickle cell disease specific quality of life (SC-QOL) for youth in the intervention group would improve from baseline to 9 months.||||0.47
73894543|NCT03462511|147321622|NON_INFERIORITY|30% of the standard deviation was used as the non-inferiority margin. For this test sickle cell disease specific quality of life (SC-QOL) scores for months 4-9 (efficacy period) were compared to months \>9 (sustainability period).||||||0.045|||||||Regression, Linear|||We hypothesized that the improvement in sickle cell disease specific quality of life (SC-QOL) experienced by the intervention group would be sustained from month 9 to month 12.||||0.045
73894544|NCT03462511|147321623|SUPERIORITY|||||||0.002|||||||Regression, Linear|||We hypothesized that, compared to the control group, responsibility for self-management concordance for youth-caregiver dyads in the intervention group would improve from baseline to 6 months.||||0.002
73894545|NCT03462511|147321623|NON_INFERIORITY|50% of the standard deviation was used as the non-inferiority margin. For this test youth caregiver concordance for self-management responsibility scores for months 0-6 (efficacy period) were compared to months 6-12 (sustainability period).||||||0.23|||||||Regression, Linear|||We hypothesized that the improvement in concordance between youth and caregivers for self-management responsibility experienced by the intervention group would be sustained from month 6 to month 12.||||0.23
73894546|NCT05408637|147321660|OTHER|The small sample size did not allow for statistical tests. Therefore, we looked at overall patterns and calculated differences between stimulation (Active vs Sham).|Mean Difference (Final Values)|54.75|||||TWO_SIDED||||||||Difference = Active - Sham|||||
73894547|NCT05408637|147321660|OTHER||Percent Difference|0.85|||||TWO_SIDED||||||||Difference = Active - Sham|The small sample size did not allow for statistical tests. Therefore, we looked at percent difference between stimulation (Active vs Sham).||||
73894548|NCT05408637|147321660|OTHER||Cohen's d|0.07|||||TWO_SIDED|||||||||We evaluated the effect size of the difference between Active and Sham using Cohen's d.||||
73894549|NCT05408637|147321661|OTHER|The small sample size did not allow for statistical tests. Therefore, we looked at overall patterns and calculated differences between active stimulation timepoints (Day 1 vs Day 5).|Mean Difference (Final Values)|224.8392|||||TWO_SIDED||||||||Difference = Day 5 Active - Day 1 Active|||||
73894550|NCT05408637|147321661|OTHER||Percent Difference|4.35|||||TWO_SIDED||||||||Difference = Day 5 Active - Day 1 Active|The small sample size did not allow for statistical tests. Therefore, we calculated percent difference between active stimulation timepoints (Day 1 vs Day 5).||||
73894551|NCT05408637|147321661|OTHER||Cohen's d|0.36|||||TWO_SIDED|||||||||We evaluated the effect size of the difference between active stimulation timepoints (Day 1 vs Day 5) using Cohen's d.||||
73894552|NCT05408637|147321662|OTHER||rank biserial correlation coefficient|0.767||||0.15|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed-rank test was used to evaluate changes in the IGT at Baseline vs Day 5 due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.||||0.15
73894553|NCT05408637|147321662|OTHER|The Friedman test was used to assess overall differences in IGT across Baseline, Day 1, and Day 5.||||||0.038|||||||Friedman test|||||||0.038
73894554|NCT05408637|147321662|OTHER|The Friedman test was used to assess overall differences in IGT across all timepoints (Baseline, Day 1, Day 5, Follow-Up).||||||0.043|||||||Friedman test|||||||0.043
73894555|NCT05408637|147321662|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the BIS across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.134||||0.42|TWO_SIDED||||||Wilcoxon signed rank test|BIS across timepoints||||||0.42
73894556|NCT05408637|147321662|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the BRIEF-A across timepoints due to the small sample size and distributional assumptions.||||||0.232|||||||Wilcoxon signed rank test|BRIEF-A across timepoints||||||0.232
73894557|NCT05408637|147321662|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the i7 Impulsivity across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.575||||0.06|TWO_SIDED||||||Wilcoxon signed rank test|i7 Impulsivity||||||0.06
73894558|NCT05408637|147321662|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the i7 Venturesomeness across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.275||||0.36|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.36
73894559|NCT05408637|147321663|OTHER|Non-parametric tests were employed to evaluate changes across MOODS-SR Baseline to Day 5 due to the small sample size and distributional assumptions. The Wilcoxon signed-rank tests were applied for pairwise comparisons. Effect sizes were calculated using Cohen's d to estimate the magnitude of change.|Cohen's d|0.12||||0.6|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.6
73894560|NCT05408637|147321663|OTHER|Non-parametric tests were employed to evaluate changes across MOODS-SR Baseline to Follow Up due to the small sample size and distributional assumptions. The Wilcoxon signed-rank tests were applied for pairwise comparisons. Effect sizes were calculated using Cohen's d to estimate the magnitude of change.|Cohen's d|0.24||||0.2|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.2
73894561|NCT00776919|147321755|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73894562|NCT00776919|147321755|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Cochran-Mantel-Haenszel|||||||0.016
73894563|NCT00776919|147321755|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73894564|NCT00776919|147321756|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
73801788|NCT03349060|147152711|SUPERIORITY||Difference in Percentage|4.6||||0.0604|TWO_SIDED|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.5|-0.3|0.0604
73801789|NCT03349060|147152711|SUPERIORITY||Difference in Percentage|11.7||||0.0022|TWO_SIDED|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|5.5|0.0022
73801790|NCT03349060|147152711|SUPERIORITY||Difference in Percentage|6.4||||0.0255|TWO_SIDED|95.0|1.2|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.6|1.2|0.0255
73801791|NCT03349060|147152711|SUPERIORITY||Difference in Percentage|13.1||||0.001|TWO_SIDED|95.0|6.7|19.4|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.7|0.0010
73801792|NCT03349060|147152712|SUPERIORITY||Difference in LS mean|-5.8|||<|0.0001|TWO_SIDED|95.0|-8.2|-3.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.3|-8.2|<0.0001
73801793|NCT03349060|147152712|SUPERIORITY||Difference in LS mean|-10.6|||<|0.0001|TWO_SIDED|95.0|-13.0|-8.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-8.1|-13.0|<0.0001
73801794|NCT03349060|147152712|SUPERIORITY||Difference in LS mean|-7.9|||<|0.0001|TWO_SIDED|95.0|-10.7|-5.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.0|-10.7|<0.0001
73801795|NCT03349060|147152712|SUPERIORITY||Difference in LS mean|-12.7|||<|0.0001|TWO_SIDED|95.0|-15.6|-9.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.9|-15.6|<0.0001
73801796|NCT03349060|147152712|SUPERIORITY||Difference in LS mean|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.6|-5.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.5|-11.6|<0.0001
73801797|NCT03349060|147152712|SUPERIORITY||Difference in LS mean|-13.5|||<|0.0001|TWO_SIDED|95.0|-16.5|-10.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.4|-16.5|<0.0001
73801798|NCT03349060|147152712|SUPERIORITY||Difference in LS mean|-8.3|||<|0.0001|TWO_SIDED|95.0|-11.6|-5.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.1|-11.6|<0.0001
73801799|NCT03349060|147152712|SUPERIORITY||Difference in LS mean|-14.0|||<|0.0001|TWO_SIDED|95.0|-17.3|-10.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.8|-17.3|<0.0001
73801800|NCT03349060|147152713|SUPERIORITY||Difference in LS mean|-7.8||||0.0004|TWO_SIDED|95.0|-12.1|-3.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.5|-12.1|0.0004
73801801|NCT03349060|147152713|SUPERIORITY||Difference in LS mean|-14.8|||<|0.0001|TWO_SIDED|95.0|-19.0|-10.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.5|-19.0|<0.0001
73801802|NCT03349060|147152713|SUPERIORITY||Difference in LS mean|-11.7|||<|0.0001|TWO_SIDED|95.0|-16.6|-6.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-6.9|-16.6|<0.0001
73801803|NCT03349060|147152713|SUPERIORITY||Difference in LS mean|-18.5|||<|0.0001|TWO_SIDED|95.0|-23.4|-13.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-13.6|-23.4|<0.0001
73801804|NCT03349060|147152713|SUPERIORITY||Difference in LS mean|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.7|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.0|-19.7|<0.0001
73801805|NCT03349060|147152713|SUPERIORITY||Difference in LS mean|-22.6|||<|0.0001|TWO_SIDED|95.0|-28.0|-17.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.3|-28.0|<0.0001
73801806|NCT03349060|147152713|SUPERIORITY||Difference in LS mean|-13.8|||<|0.0001|TWO_SIDED|95.0|-19.3|-8.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-8.2|-19.3|<0.0001
73801807|NCT03349060|147152713|SUPERIORITY||Difference in LS mean|-22.0|||<|0.0001|TWO_SIDED|95.0|-27.6|-16.5|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.5|-27.6|<0.0001
73801808|NCT03349060|147152714|SUPERIORITY||Difference in Percentage|1.3||||0.521|TWO_SIDED|95.0|-3.4|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-3.4|0.5210
73801809|NCT03349060|147152714|SUPERIORITY||Difference in Percentage|4.0||||0.1416|TWO_SIDED|95.0|-1.3|9.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.3|-1.3|0.1416
73801810|NCT03349060|147152714|SUPERIORITY||Difference in Percentage|4.6||||0.2002|TWO_SIDED|95.0|-2.1|11.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.2|-2.1|0.2002
73801811|NCT03349060|147152714|SUPERIORITY||Difference in Percentage|23.6|||<|0.0001|TWO_SIDED|95.0|15.1|32.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.2|15.1|<0.0001
73801812|NCT03349060|147152714|SUPERIORITY||Difference in Percentage|9.6||||0.0434|TWO_SIDED|95.0|1.3|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|1.3|0.0434
73801813|NCT03349060|147152714|SUPERIORITY||Difference in Percentage|26.6|||<|0.0001|TWO_SIDED|95.0|17.1|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.2|17.1|<0.0001
73801814|NCT03349060|147152714|SUPERIORITY||Difference in Percentage|15.8||||0.0019|TWO_SIDED|95.0|7.5|24.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.0|7.5|0.0019
73801815|NCT03349060|147152714|SUPERIORITY||Difference in Percentage|33.3|||<|0.0001|TWO_SIDED|95.0|24.0|42.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.7|24.0|<0.0001
73801816|NCT03349060|147152715|SUPERIORITY||Difference in Percentage|10.8||||0.0151|TWO_SIDED|95.0|3.3|18.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.3|3.3|0.0151
73801817|NCT03349060|147152715|SUPERIORITY||Difference in Percentage|30.0|||<|0.0001|TWO_SIDED|95.0|21.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|21.0|<0.0001
73801818|NCT03349060|147152715|SUPERIORITY||Difference in Percentage|21.2||||0.001|TWO_SIDED|95.0|10.2|32.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.3|10.2|0.0010
73801819|NCT03349060|147152715|SUPERIORITY||Difference in Percentage|37.9|||<|0.0001|TWO_SIDED|95.0|26.6|49.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.3|26.6|<0.0001
73801820|NCT03349060|147152715|SUPERIORITY||Difference in Percentage|23.5||||0.0003|TWO_SIDED|95.0|12.6|34.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.3|12.6|0.0003
73801821|NCT03349060|147152715|SUPERIORITY||Difference in Percentage|41.7|||<|0.0001|TWO_SIDED|95.0|30.7|52.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||52.7|30.7|<0.0001
73801822|NCT03349060|147152715|SUPERIORITY||Difference in Percentage|19.6||||0.0026|TWO_SIDED|95.0|8.1|31.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.1|8.1|0.0026
73894565|NCT00776919|147321756|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.015
73801823|NCT03349060|147152715|SUPERIORITY||Difference in Percentage|40.0|||<|0.0001|TWO_SIDED|95.0|28.3|51.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||51.7|28.3|<0.0001
73801824|NCT03349060|147152716|SUPERIORITY||Difference in Percentage|1.3||||0.3151|TWO_SIDED|95.0|-2.9|5.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.6|-2.9|0.3151
73801825|NCT03349060|147152716|SUPERIORITY||Difference in Percentage|6.0||||0.0292|TWO_SIDED|95.0|0.7|11.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.3|0.7|0.0292
73801826|NCT03349060|147152716|SUPERIORITY||Difference in Percentage|-0.2||||0.9402|TWO_SIDED|95.0|-5.9|5.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.5|-5.9|0.9402
73801827|NCT03349060|147152716|SUPERIORITY||Difference in Percentage|15.3||||0.0019|TWO_SIDED|95.0|7.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.2|7.3|0.0019
73801828|NCT03349060|147152716|SUPERIORITY||Difference in Percentage|10.8||||0.0078|TWO_SIDED|95.0|4.2|17.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.4|4.2|0.0078
73801829|NCT03349060|147152716|SUPERIORITY||Difference in Percentage|22.2|||<|0.0001|TWO_SIDED|95.0|14.2|30.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.1|14.2|<0.0001
73801830|NCT03349060|147152716|SUPERIORITY||Difference in Percentage|8.2||||0.0528|TWO_SIDED|95.0|1.0|15.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.3|1.0|0.0528
73801831|NCT03349060|147152716|SUPERIORITY||Difference in Percentage|26.4|||<|0.0001|TWO_SIDED|95.0|17.6|35.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.3|17.6|<0.0001
73801832|NCT03349060|147152717|SUPERIORITY||Difference in LS mean|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.9|<0.0001
73801833|NCT03349060|147152717|SUPERIORITY||Difference in LS mean|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-3.0|<0.0001
73801834|NCT03349060|147152717|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-2.2|<0.0001
73801835|NCT03349060|147152717|SUPERIORITY||Difference in LS mean|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.4|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.0|-3.4|<0.0001
73801836|NCT03349060|147152717|SUPERIORITY||Difference in LS mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.8|-2.3|<0.0001
73801837|NCT03349060|147152717|SUPERIORITY||Difference in LS mean|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.8|-3.2|<0.0001
73801838|NCT03349060|147152717|SUPERIORITY||Difference in LS mean|-1.3||||0.0005|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.1|0.0005
73801839|NCT03349060|147152717|SUPERIORITY||Difference in LS mean|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-2.9|<0.0001
73894566|NCT00776919|147321756|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
73801840|NCT03349060|147152718|SUPERIORITY||Difference in LS mean|-10.9|||<|0.0001|TWO_SIDED|95.0|-14.8|-7.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.0|-14.8|<0.0001
73801841|NCT03349060|147152718|SUPERIORITY||Difference in LS mean|-18.9|||<|0.0001|TWO_SIDED|95.0|-22.7|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.1|-22.7|<0.0001
73894567|NCT00776919|147321757|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
73894568|NCT00776919|147321757|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.102
73894569|NCT00776919|147321757|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
73894570|NCT00776919|147321758|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
73894571|NCT00776919|147321758|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.032
73894572|NCT00776919|147321758|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
73894573|NCT03116152|147321771|SUPERIORITY||Hazard Ratio (HR)|0.701||||0.032|TWO_SIDED|95.0|0.504|0.972|||Log Rank|||||0.972|0.504|0.032
73894574|NCT03116152|147321772|SUPERIORITY||Hazard Ratio (HR)|1.002||||0.979|TWO_SIDED|95.0|0.722|1.391|||Log Rank|||||1.391|0.722|0.979
73801842|NCT03349060|147152718|SUPERIORITY||Difference in LS mean|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.3|-7.8|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.8|-17.3|<.0001
73894575|NCT03116152|147321773|SUPERIORITY||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-2.2|15.4||||||||15.4|-2.2|
73801843|NCT03349060|147152718|SUPERIORITY||Difference in LS mean|-22.1|||<|0.0001|TWO_SIDED|95.0|-26.8|-17.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.3|-26.8|<.0001
73801844|NCT03349060|147152718|SUPERIORITY||Difference in LS mean|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.5|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.0|-19.5|<.0001
73801845|NCT03349060|147152718|SUPERIORITY||Difference in LS mean|-22.0|||<|0.0001|TWO_SIDED|95.0|-27.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.7|-27.2|<.0001
73894576|NCT03116152|147321774|SUPERIORITY|||||||0.345|||||||Log Rank|||||||0.345
73894577|NCT02791763|147321783|NON_INFERIORITY|Non-inferiority was to be established as the lower limit of the 95% confidence interval (CI) for the treatment difference was greater than the pre-specified non-inferiority margin (-1.0 g/dL).|Median Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.07|0.28||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction and Baseline-by-visit interaction.|||0.28|-0.07|<.0001
73894578|NCT02791763|147321784|SUPERIORITY||Odds Ratio (OR)|1.01||||0.4941|TWO_SIDED|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.|||3.04|0.33|0.4941
73894579|NCT02791763|147321785|SUPERIORITY||Odds Ratio (OR)|1.01||||0.4941|TWO_SIDED|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.|||3.04|0.33|0.4941
73894580|NCT02878798|147321870|OTHER|Non-inferiority and superiority tests were completed|Slope|0.2105|||||ONE_SIDED|95.0|-0.4328||||||||||-0.4328|
73894581|NCT02878798|147321871|OTHER|Non-inferiority and superiority tests were done|Slope|-1.5219|||||ONE_SIDED|95.0||1.1933||||||||1.1933||
73894582|NCT02878798|147321872|SUPERIORITY||Slope|-0.02322|||||TWO_SIDED|95.0|-0.6337|0.5872|||Mixed Models Analysis|||||0.5872|-0.6337|
73894583|NCT02878798|147321873|SUPERIORITY||Slope|-0.168||||0.261|TWO_SIDED|95.0|-0.4612|0.1253|||Mixed Models Analysis|||||0.1253|-0.4612|0.261
73894584|NCT02878798|147321874|SUPERIORITY||Slope|-0.061||||0.9007|TWO_SIDED|95.0|-1.0213|0.8992|||Mixed Models Analysis|||||0.8992|-1.0213|0.9007
73894585|NCT02878798|147321875|SUPERIORITY||Slope|0.0106||||0.8174|TWO_SIDED|95.0|-0.0793|0.1005|||Hurdle model|||||0.1005|-0.0793|0.8174
73894586|NCT02878798|147321876|SUPERIORITY||Slope|-0.7394||||0.0233|TWO_SIDED|95.0|-1.3775|-0.1013|||Mixed Models Analysis|||||-0.1013|-1.3775|0.0233
73894587|NCT02878798|147321877|SUPERIORITY||Slope|-0.1328||||0.7586|TWO_SIDED|95.0|-0.982|0.7164|||Mixed Models Analysis|||||0.7164|-0.982|0.7586
73894588|NCT02878798|147321878|SUPERIORITY||Slope|-0.0021||||0.9604|TWO_SIDED|95.0|-0.084|0.0799|||Mixed Models Analysis|||||0.0799|-0.084|0.9604
73894589|NCT02878798|147321879|SUPERIORITY||Slope|-0.0396||||0.2365|TWO_SIDED|95.0|-0.1053|0.0261|||Mixed Models Analysis|||||0.0261|-0.1053|0.2365
73894590|NCT02878798|147321880|SUPERIORITY||Slope|2.3848||||0.5813|TWO_SIDED|95.0|-6.1336|10.9032|||Mixed Models Analysis|||||10.9032|-6.1336|0.5813
73894591|NCT02878798|147321881|SUPERIORITY||Slope|-1.0547||||0.4092|TWO_SIDED|95.0|-3.5705|1.4611|||Mixed Models Analysis|||||1.4611|-3.5705|0.4092
73801846|NCT03349060|147152718|SUPERIORITY||Difference in LS mean|-13.3|||<|0.0001|TWO_SIDED|95.0|-19.0|-7.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.7|-19.0|<0.0001
73801847|NCT03349060|147152718|SUPERIORITY||Difference in LS mean|-21.9|||<|0.0001|TWO_SIDED|95.0|-27.5|-16.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.3|-27.5|<.0001
73801848|NCT03349060|147152719|SUPERIORITY||Difference in Percentage|22.3||||0.0028|TWO_SIDED|95.0|8.7|35.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.9|8.7|0.0028
73801849|NCT03349060|147152719|SUPERIORITY||Difference in Percentage|40.1|||<|0.0001|TWO_SIDED|95.0|27.1|53.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.2|27.1|<0.0001
73801850|NCT03349060|147152719|SUPERIORITY||Difference in Percentage|17.1||||0.0217|TWO_SIDED|95.0|2.8|31.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.4|2.8|0.0217
73801851|NCT03349060|147152719|SUPERIORITY||Difference in Percentage|32.2|||<|0.0001|TWO_SIDED|95.0|18.5|45.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.9|18.5|<0.0001
73801852|NCT03349060|147152719|SUPERIORITY||Difference in Percentage|15.7||||0.0363|TWO_SIDED|95.0|1.4|30.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.0|1.4|0.0363
73801853|NCT03349060|147152719|SUPERIORITY||Difference in Percentage|23.7||||0.0011|TWO_SIDED|95.0|9.8|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.7|9.8|0.0011
73801854|NCT03349060|147152719|SUPERIORITY||Difference in Percentage|20.1||||0.008|TWO_SIDED|95.0|5.8|34.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.5|5.8|0.0080
73801855|NCT03349060|147152719|SUPERIORITY||Difference in Percentage|29.1|||<|0.0001|TWO_SIDED|95.0|15.0|43.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.3|15.0|<0.0001
73801856|NCT03349060|147152720|SUPERIORITY||Difference in LS mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.4|-2.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.2|-5.4|<0.0001
73801857|NCT03349060|147152720|SUPERIORITY||Difference in LS mean|-5.5|||<|0.0001|TWO_SIDED|95.0|-7.1|-3.9|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.9|-7.1|<0.0001
73894592|NCT00101452|147321896|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73894593|NCT05477108|147321913|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 42.91. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.1028 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|104.24|||||TWO_SIDED|90.0|95.78|113.44|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||113.44|95.78|
73894594|NCT05477108|147321913|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 40.85. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0831 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|93.45|||||TWO_SIDED|90.0|84.31|103.58|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||103.58|84.31|
73894595|NCT05477108|147321913|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 40.66. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0971 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|100.14|||||TWO_SIDED|90.0|91.9|109.11|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||109.11|91.90|
73894596|NCT05477108|147321913|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 42.66. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 73.29% to 136.44% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|103.12|||||TWO_SIDED|90.0|94.44|112.6|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (EU approach)||112.60|94.44|
73894597|NCT05477108|147321913|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 40.75. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 74.24% to 134.70% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|93.39|||||TWO_SIDED|90.0|85.29|102.26|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (EU approach)||102.26|85.29|
73894598|NCT05477108|147321913|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 40.81. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 74.21% to 134.75% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|99.7|||||TWO_SIDED|90.0|91.44|108.71|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (EU approach)||108.71|91.44|
73894599|NCT05477108|147321914|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 34.29. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0593 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|107.76|||||TWO_SIDED|90.0|100.35|115.72|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||115.72|100.35|
73894600|NCT05477108|147321914|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 86.08. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2925 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Ratio Mean (%)|112.22|||||TWO_SIDED|90.0|92.27|136.49|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||136.49|92.27|
73894601|NCT05477108|147321914|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 47.07. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.1250 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|101.45|||||TWO_SIDED|90.0|91.76|112.15|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||112.15|91.76|
73894602|NCT05477108|147321915|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 35.68. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0668 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|106.87|||||TWO_SIDED|90.0|99.3|115.01|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||115.01|99.30|
73894603|NCT05477108|147321915|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 74.17. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2735 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|102.02|||||TWO_SIDED|90.0|89.12|116.79|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||116.79|89.12|
73894604|NCT05477108|147321915|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 66.88. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2210 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|107.76|||||TWO_SIDED|90.0|94.91|122.36|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||122.36|94.91|
73894605|NCT05477108|147321915|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean ratio (%)|106.1|||||TWO_SIDED|90.0|98.39|114.41|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (EU approach)||114.41|98.39|
73894606|NCT05477108|147321915|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean Ratio (%)|97.02|||||TWO_SIDED|90.0|84.18|111.82|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (EU approach)||111.82|84.18|
73801858|NCT03349060|147152720|SUPERIORITY||Difference in LS mean|-3.3||||0.0001|TWO_SIDED|95.0|-5.0|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-5.0|0.0001
73894607|NCT05477108|147321915|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean Ratio (%)|105.74|||||TWO_SIDED|90.0|92.59|120.75|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (EU approach)||120.75|92.59|
73894608|NCT02660983|147321923|SUPERIORITY||Difference in least square (LS) means|-0.58||||0.3455|TWO_SIDED|95.0|-1.79|0.63|||ANCOVA|||||0.63|-1.79|0.3455
73894609|NCT02660983|147321924|SUPERIORITY||Difference in LS means|-0.12||||0.257|TWO_SIDED|95.0|-0.32|0.09|||ANCOVA||LS mean of Donepezil group - LS mean of Placebo (when the difference of LS mean scores were less than 0, considered as demonstrated hypothesis), analyzed with ANCOVA model with baseline (CIBIS) as covariate and treatment as main effect.|||0.09|-0.32|0.2570
73894610|NCT02660983|147321925|SUPERIORITY||Difference in LS means|0.65||||0.0396|TWO_SIDED|95.0|0.03|1.26|||ANCOVA|||||1.26|0.03|0.0396
73894611|NCT02660983|147321926|SUPERIORITY||Difference in LS means|-7.73||||0.2213|TWO_SIDED|95.0|-20.13|4.68|||ANCOVA|||Part A||4.68|-20.13|0.2213
73894612|NCT02660983|147321926|SUPERIORITY||Difference in LS means|-14.88||||0.0551|TWO_SIDED|95.0|-30.1|0.33|||ANCOVA|||Part B||0.33|-30.10|0.0551
73894613|NCT03376295|147321931|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.9|1.2|||Cox proportional hazards model||The hazard ratio (HR) is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for moderate/severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.20|0.90|
73894614|NCT03376295|147321931|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.65|1.36|||Cox proportional hazards model||HR presented is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.36|0.65|
73894615|NCT03376295|147321932|OTHER||Rate ratio (RR)|1.07|||||TWO_SIDED|95.0|0.92|1.25|||Negative binomial model||The rate ratio (RR) (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Moderate/severe exacerbation||1.25|0.92|
73894616|NCT03376295|147321932|OTHER||Rate ratio (RR)|0.85|||||TWO_SIDED|95.0|0.55|1.33|||Negative binomial model||The RR (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Severe exacerbation||1.33|0.55|
73894617|NCT03376295|147321933|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.42|1.05|||Cox proportional hazards model||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The cox proportional hazard regression model was used to perform an as-treated analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.05|0.42|
73894618|NCT03376295|147321933|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.48|0.92|||Cox proportional hazards model||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The Cox proportional hazard regression model was used to perform an on-treatment analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||0.92|0.48|
73894619|NCT00893815|147321934|OTHER||Odds Ratio (OR)|0.55||||0.09|TWO_SIDED|95.0|0.27|1.1||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|||1.10|0.27|0.09
73894620|NCT00893815|147321935|OTHER||Odds Ratio (OR)|0.75||||0.45|TWO_SIDED|95.0|0.35|1.61||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of verbal fluency impairment between HIV-positive and HIV-negative military beneficiaries||1.61|0.35|0.45
73894621|NCT00893815|147321935|OTHER||Odds Ratio (OR)|0.74||||0.43|TWO_SIDED|95.0|0.35|1.56||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of abstraction executive functioning impairment between HIV-positive and HIV-negative military beneficiaries||1.56|0.35|0.43
73894622|NCT00893815|147321935|OTHER||Odds Ratio (OR)|1.45||||0.56|TWO_SIDED|95.0|0.41|5.17||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of speed of information processing impairment between HIV-positive and HIV-negative military beneficiaries||5.17|0.41|0.56
73894623|NCT00893815|147321935|OTHER||Odds Ratio (OR)|1.32||||0.49|TWO_SIDED|95.0|0.6|2.93||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of attention/working memory impairment between HIV-positive and HIV-negative military beneficiaries||2.93|0.60|0.49
73894624|NCT00893815|147321935|OTHER||Odds Ratio (OR)|0.43||||0.01|TWO_SIDED|95.0|0.22|0.84||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of learning impairment between HIV-positive and HIV-negative military beneficiaries||0.84|0.22|0.01
73894625|NCT00893815|147321935|OTHER||Odds Ratio (OR)|1.39||||0.46|TWO_SIDED|95.0|0.58|3.34||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of recall impairment between HIV-positive and HIV-negative military beneficiaries||3.34|0.58|0.46
73894626|NCT00893815|147321935|OTHER||Odds Ratio (OR)|0.89||||0.76|TWO_SIDED|95.0|0.43|1.85||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of motor speed \& dexterity impairment between HIV-positive and HIV-negative military beneficiaries||1.85|0.43|0.76
73894627|NCT05688670|147321946|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.001|TWO_SIDED|95.0|-0.59|-0.18|||t-test, 2 sided|||||-0.18|-0.59|0.001
73801859|NCT03349060|147152720|SUPERIORITY||Difference in LS mean|-6.1|||<|0.0001|TWO_SIDED|95.0|-7.8|-4.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.5|-7.8|<.0001
73801860|NCT03349060|147152720|SUPERIORITY||Difference in LS mean|-2.8||||0.0075|TWO_SIDED|95.0|-4.8|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-4.8|0.0075
73801861|NCT03349060|147152720|SUPERIORITY||Difference in LS mean|-5.3|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.3|-7.4|<0.0001
73801862|NCT03349060|147152720|SUPERIORITY||Difference in LS mean|-2.8||||0.0072|TWO_SIDED|95.0|-4.8|-0.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.8|-4.8|0.0072
73801863|NCT03349060|147152720|SUPERIORITY||Difference in LS mean|-4.9|||<|0.0001|TWO_SIDED|95.0|-6.9|-2.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.9|-6.9|<0.0001
73801864|NCT03349060|147152721|SUPERIORITY||Difference in LS mean|-1.3||||0.275|TWO_SIDED|95.0|-3.5|1.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||1.0|-3.5|0.2750
73801865|NCT03349060|147152721|SUPERIORITY||Difference in LS mean|-2.5||||0.028|TWO_SIDED|95.0|-4.8|-0.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-4.8|0.0280
73801866|NCT03349060|147152721|SUPERIORITY||Difference in LS mean|-3.5||||0.0051|TWO_SIDED|95.0|-5.9|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.1|-5.9|0.0051
73801867|NCT03349060|147152721|SUPERIORITY||Difference in LS mean|-6.4|||<|0.0001|TWO_SIDED|95.0|-8.8|-4.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.0|-8.8|<0.0001
73801868|NCT03349060|147152721|SUPERIORITY||Difference in LS mean|-2.1||||0.1706|TWO_SIDED|95.0|-5.1|0.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.9|-5.1|0.1706
73801869|NCT03349060|147152721|SUPERIORITY||Difference in LS mean|-4.4||||0.0048|TWO_SIDED|95.0|-7.4|-1.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-7.4|0.0048
73801870|NCT03349060|147152721|SUPERIORITY||Difference in LS mean|-2.5||||0.0629|TWO_SIDED|95.0|-5.2|0.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.1|-5.2|0.0629
73801871|NCT03349060|147152721|SUPERIORITY||Difference in LS mean|-3.6||||0.01|TWO_SIDED|95.0|-6.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-6.2|0.0100
73801872|NCT03349060|147152722|SUPERIORITY||Difference in Percentage|6.6||||0.1238|TWO_SIDED|95.0|-0.7|13.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||13.9|-0.7|0.1238
73801873|NCT03349060|147152722|SUPERIORITY||Difference in Percentage|20.1||||0.0008|TWO_SIDED|95.0|11.0|29.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.2|11.0|0.0008
73801874|NCT03349060|147152722|SUPERIORITY||Difference in Percentage|6.8||||0.2091|TWO_SIDED|95.0|-2.8|16.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.4|-2.8|0.2091
73801875|NCT03349060|147152722|SUPERIORITY||Difference in Percentage|24.0||||0.0005|TWO_SIDED|95.0|12.9|35.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.0|12.9|0.0005
73801876|NCT03349060|147152722|SUPERIORITY||Difference in Percentage|9.1||||0.1161|TWO_SIDED|95.0|-0.9|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.1|-0.9|0.1161
73801877|NCT03349060|147152722|SUPERIORITY||Difference in Percentage|26.5||||0.0002|TWO_SIDED|95.0|15.3|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.7|15.3|0.0002
73894628|NCT05688670|147321947|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.41|TWO_SIDED|95.0|-0.2|0.08|||t-test, 2 sided|||12-24 hour postoperative opioid use||0.08|-0.20|0.41
73894629|NCT05688670|147321947|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.14|TWO_SIDED|95.0|-0.37|0.06|||t-test, 2 sided|||24-48 hour postoperative opioid use||0.06|-0.37|0.14
73894630|NCT05688670|147321947|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.16|TWO_SIDED|95.0|-0.52|0.09|||t-test, 2 sided|||12-48 hours hours after surgery||0.09|-0.52|0.16
73894631|NCT05688670|147321948|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.004|TWO_SIDED|95.0|-1.02|-0.22|||t-test, 2 sided|||||-0.22|-1.02|0.004
73894632|NCT05688670|147321949|SUPERIORITY||Mean Difference (Final Values)|-49.5||||0.002|TWO_SIDED|95.0|-78.9|-20.1|||t-test, 2 sided|||||-20.1|-78.9|0.002
73894633|NCT03425253|147321951|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Both Sides of Face, Last Treatment||||<0.001
73894634|NCT03425253|147321951|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Right Side of Face, Last Treatment||||<0.001
73894635|NCT03425253|147321951|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Left Side of Face, Last Treatment||||<0.001
73894636|NCT03425253|147321951|OTHER|||||||0.018||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Both Sides of Face, Last Treatment||||0.018
73894637|NCT03425253|147321951|OTHER|||||||0.301||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Right Side of Face, Last Treatment||||0.301
73894638|NCT03425253|147321951|OTHER|||||||0.011||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Left Side of Face, Last Treatment||||0.011
73801878|NCT03349060|147152722|SUPERIORITY||Difference in Percentage|8.1||||0.1837|TWO_SIDED|95.0|-2.8|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.1|-2.8|0.1837
73894639|NCT03425253|147321952|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
73894640|NCT03425253|147321953|OTHER|||||||0.597||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||0.597
73894641|NCT03425253|147321954|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
73894642|NCT03425253|147321955|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
73894643|NCT03425253|147321956|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
73894644|NCT03425253|147321957|OTHER|||||||0.003||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||0.003
73894645|NCT03425253|147321958|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Both Side of the Face, End of Study||||<0.001
73894646|NCT03425253|147321958|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Right Side of the Face, End of study||||<0.001
73894647|NCT03425253|147321958|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Left Side of the Face, End of Study||||<0.001
73894648|NCT00689117|147321976|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.063
73894649|NCT00689117|147321976|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.003
73894650|NCT00689117|147321976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||<0.001
73894651|NCT00689117|147321976|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.004
73894652|NCT00689117|147321976|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.550
73894653|NCT00689117|147321976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
73894654|NCT00689117|147321976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
73894655|NCT00689117|147321976|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Total lesion count|Ranked ANCOVA|||||||0.016
73894656|NCT00689117|147321976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
73894657|NCT00689117|147321977|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||0.001
73894658|NCT00689117|147321977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||<0.001
73894659|NCT00689117|147321977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||<0.001
73894660|NCT00689117|147321978|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.065
73894661|NCT00689117|147321978|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.002
73894662|NCT00689117|147321978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||<0.001
73894663|NCT00689117|147321978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
73894664|NCT00689117|147321978|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.284
73894665|NCT00689117|147321978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
73894666|NCT00689117|147321978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
73894667|NCT00689117|147321978|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||Total lesion count|Ranked ANCOVA|||||||0.028
73894668|NCT00689117|147321978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
73894669|NCT00689117|147321979|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||Cochran-Mantel-Haenszel|||||||0.671
73894670|NCT00689117|147321979|SUPERIORITY_OR_OTHER|||||||0.919||95.0|||||Cochran-Mantel-Haenszel|||||||0.919
73894671|NCT00689117|147321979|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
73894672|NCT00689117|147321980|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
73894673|NCT00689117|147321980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73894674|NCT00689117|147321980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73894675|NCT02223377|147322010|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.56|1.78|||Regression, Logistic|||||1.78|0.56|0.997
73894676|NCT02223377|147322015|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.04|TWO_SIDED|95.0|-1.43|-0.03|||ANOVA|||||-0.03|-1.43|0.040
73894677|NCT01086358|147322048|SUPERIORITY||Mean Difference (Final Values)|-1.71||||0.007|TWO_SIDED|95.0|-2.92|-0.49|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||-0.49|-2.92|0.007
73894678|NCT01086358|147322049|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.01|TWO_SIDED|95.0|-1.79|-0.27|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||-0.27|-1.79|0.010
73894679|NCT01086358|147322050|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.059|TWO_SIDED|95.0|-1.39|0.03|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order.||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||0.03|-1.39|0.059
73894680|NCT01086358|147322051|SUPERIORITY||Odds Ratio (OR)|2.89||||0.016|TWO_SIDED|95.0|1.22|6.84|||Regression, Logistic|As noted above, results are adjusted for study period and treatment order.||Logistic regression models with generalized estimating equations were used. In these models, a logit link function was used for a favorable response (yes/no) with treatment as the primary fixed effect and including study period and treatment order as other fixed effects..||6.84|1.22|0.016
73894681|NCT01767142|147322054|OTHER||sucess proportion|83.9|||||TWO_SIDED|95.0|74.8|90.7||||||||90.7|74.8|
73894682|NCT04975230|147322056|OTHER||Cohen's D|0.17|STANDARD_ERROR_OF_MEAN|0.17||0.0227|TWO_SIDED|95.0|-0.37|0.78|||Mixed Models Analysis|||||0.78|-0.37|0.0227
73801879|NCT03349060|147152722|SUPERIORITY||Difference in Percentage|19.8||||0.0046|TWO_SIDED|95.0|8.1|31.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.6|8.1|0.0046
73894683|NCT02471612|147322080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||||||Comparing the sensitivity of APACHE-II and P-POSSUM|McNemar|||"Area under the curve (AUC) is used to measure the size of the prediction composed by the graphic display between the 'sensitivity' and the '1-specificity' relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value \> 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value \< 0.60 is regarded as poor."||||0.665
73801880|NCT03349060|147152723|SUPERIORITY||Difference in Percentage|3.2||||0.4795|TWO_SIDED|95.0|-10.3|16.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.6|-10.3|0.4795
73801881|NCT03349060|147152723|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.7|-12.7|
73894684|NCT05194579|147322113|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% confidence intervals (CIs) for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays Cmax statistical analysis.|Ratio of Geometric Mean|117.06|||||TWO_SIDED|90.0|103.07|132.93|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||132.93|103.07|
73894685|NCT05194579|147322114|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% CIs for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays AUClast statistical analysis.|Ratio of Geometric Mean|122.12|||||TWO_SIDED|90.0|107.9|138.22|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||138.22|107.90|
73894686|NCT05194579|147322115|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% CIs for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays AUCinf statistical analysis.|Ratio of Geometric Mean|123.75|||||TWO_SIDED|90.0|108.75|140.82|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||140.82|108.75|
73894687|NCT03495856|147322130|OTHER|within-group paired t-test|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.37||0.05|TWO_SIDED|95.0|-1.55|0.0||The a priori threshold for statistical significance was p less than or equal to 0.05. That calculated p-value in the statistical hypothesis test was equal to 0.05.|t-test, 2 sided|||||0.00|-1.55|0.05
73894688|NCT03495856|147322131|OTHER|within-group paired t-test|Mean Difference (Final Values)|-3.67|STANDARD_ERROR_OF_MEAN|1.42||0.017|TWO_SIDED|95.0|-6.63|-0.71|||t-test, 2 sided|||||-0.71|-6.63|0.017
73894689|NCT03495856|147322132|OTHER|Within-group paired t-test|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.7||0.938|TWO_SIDED|95.0|-1.39|1.5|||t-test, 2 sided|||||1.50|-1.39|0.938
73894690|NCT03495856|147322133|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-3.34|STANDARD_ERROR_OF_MEAN|1.05||0.005|TWO_SIDED|95.0|-5.53|-1.15||The a priori threshold for statistical significance was p less than or equal to 0.05.|t-test, 2 sided|||||-1.15|-5.53|0.005
73894691|NCT03495856|147322134|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|1.38||0.124|TWO_SIDED|95.0|-5.09|0.66|||t-test, 2 sided|||||0.66|-5.09|0.124
73894692|NCT03495856|147322135|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-4.69|STANDARD_ERROR_OF_MEAN|1.26||0.001|TWO_SIDED|95.0|-7.3|-2.07|||t-test, 2 sided|||||-2.07|-7.30|0.001
73894693|NCT03495856|147322136|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.5||0.018|TWO_SIDED|95.0|-2.31|-0.24|||t-test, 2 sided|||||-0.24|-2.31|0.018
73894694|NCT03495856|147322137|OTHER|Within-group paired t-test|Mean Difference (Final Values)|2.79|STANDARD_ERROR_OF_MEAN|1.07||0.016|TWO_SIDED|95.0|0.58|5.01|||t-test, 2 sided|||||5.01|0.58|0.016
73801882|NCT03349060|147152723|SUPERIORITY||Difference in Percentage|13.3||||0.1452|TWO_SIDED|95.0|-3.6|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.3|-3.6|0.1452
73801883|NCT03349060|147152723|SUPERIORITY||Difference in Percentage|9.7||||0.2232|TWO_SIDED|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-6.1|0.2232
73801884|NCT03349060|147152723|SUPERIORITY||Difference in Percentage|5.8||||0.5707|TWO_SIDED|95.0|-13.7|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-13.7|0.5707
73801885|NCT03349060|147152723|SUPERIORITY||Difference in Percentage|5.8||||0.5777|TWO_SIDED|95.0|-13.6|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.1|-13.6|0.5777
73801886|NCT03349060|147152723|SUPERIORITY||Difference in Percentage|19.3||||0.0744|TWO_SIDED|95.0|1.0|37.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.5|1.0|0.0744
73801887|NCT03349060|147152723|SUPERIORITY||Difference in Percentage|9.7||||0.2232|TWO_SIDED|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-6.1|0.2232
73801888|NCT03349060|147152724|SUPERIORITY||Difference in Percentage|31.6|||<|0.0001|TWO_SIDED|95.0|17.2|46.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.0|17.2|<0.0001
73801889|NCT03349060|147152724|SUPERIORITY||Difference in Percentage|35.7|||<|0.0001|TWO_SIDED|95.0|21.5|49.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.9|21.5|<0.0001
73801890|NCT03349060|147152724|SUPERIORITY||Difference in Percentage|20.4||||0.009|TWO_SIDED|95.0|5.2|35.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.6|5.2|0.0090
73801891|NCT03349060|147152724|SUPERIORITY||Difference in Percentage|33.3|||<|0.0001|TWO_SIDED|95.0|19.0|47.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.7|19.0|<0.0001
73801892|NCT03349060|147152724|SUPERIORITY||Difference in Percentage|16.5||||0.0421|TWO_SIDED|95.0|0.6|32.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.4|0.6|0.0421
73801893|NCT03349060|147152724|SUPERIORITY||Difference in Percentage|33.8|||<|0.0001|TWO_SIDED|95.0|18.9|48.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.8|18.9|<0.0001
73801894|NCT03349060|147152724|SUPERIORITY||Difference in Percentage|23.5||||0.0035|TWO_SIDED|95.0|8.2|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.8|8.2|0.0035
73801895|NCT03349060|147152724|SUPERIORITY||Difference in Percentage|28.8||||0.0002|TWO_SIDED|95.0|13.8|43.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.9|13.8|0.0002
73801896|NCT03349060|147152725|SUPERIORITY||Difference in Percentage|17.1||||0.2497|TWO_SIDED|95.0|-9.1|43.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.2|-9.1|0.2497
73801897|NCT03349060|147152725|SUPERIORITY||Difference in Percentage|17.1||||0.2371|TWO_SIDED|95.0|-9.0|43.3|||Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.3|-9.0|0.2371
73801898|NCT03349060|147152725|SUPERIORITY||Difference in Percentage|28.8||||0.0697|TWO_SIDED|95.0|-0.8|58.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.3|-0.8|0.0697
73801899|NCT03349060|147152725|SUPERIORITY||Difference in Percentage|43.9||||0.003|TWO_SIDED|95.0|16.2|71.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||71.7|16.2|0.0030
73894695|NCT03495856|147322138|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-4.96|STANDARD_ERROR_OF_MEAN|1.41||0.002|TWO_SIDED|95.0|-7.88|-2.03|||t-test, 2 sided|||||-2.03|-7.88|0.002
73894696|NCT03495856|147322139|OTHER|Within-group paired t-test|Mean Difference (Final Values)|13.27|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|8.47|18.07|||t-test, 2 sided|||||18.07|8.47|<0.001
73894697|NCT03495856|147322140|OTHER|Within-group paired t-test|Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|1.96||0.001|TWO_SIDED|95.0|3.92|12.08|||t-test, 2 sided|||||12.08|3.92|0.001
73894698|NCT00435045|147322145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the non-HDL-C response was assessed by calculating the 2-sided 90% and 95% confidence intervals (CIs)for each difference in response based on comparing the effects of increases in atorvastatin dose on the percent changes from baseline to the end of each atorvastatin period, a repeated-ANOVA model was used.||||||0.0002||95.0|||||ANOVA|||||||0.0002
73801900|NCT03349060|147152725|SUPERIORITY||Difference in Percentage|31.0||||0.0583|TWO_SIDED|95.0|2.0|59.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||59.9|2.0|0.0583
73801901|NCT03349060|147152725|SUPERIORITY||Difference in Percentage|41.2||||0.0085|TWO_SIDED|95.0|13.2|69.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||69.1|13.2|0.0085
73801902|NCT03349060|147152725|SUPERIORITY||Difference in Percentage|19.3||||0.1948|TWO_SIDED|95.0|-9.8|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.5|-9.8|0.1948
73801903|NCT03349060|147152725|SUPERIORITY||Difference in Percentage|30.6||||0.0296|TWO_SIDED|95.0|2.8|58.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.5|2.8|0.0296
73801904|NCT03349060|147152726|SUPERIORITY||Difference in LS mean|-0.5||||0.1718|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.2|-1.1|0.1718
73801905|NCT03349060|147152726|SUPERIORITY||Difference in LS mean|-1.1||||0.0018|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.7|0.0018
73801906|NCT03349060|147152726|SUPERIORITY||Difference in LS mean|-1.3||||0.0005|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.0|0.0005
73801907|NCT03349060|147152726|SUPERIORITY||Difference in LS mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.1|-2.5|<0.0001
73801908|NCT03349060|147152726|SUPERIORITY||Difference in LS mean|-0.7||||0.0476|TWO_SIDED|95.0|-1.5|0.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.0|-1.5|0.0476
73801909|NCT03349060|147152726|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.0|-2.4|<0.0001
73801910|NCT03349060|147152726|SUPERIORITY||Difference in LS mean|-1.1||||0.0028|TWO_SIDED|95.0|-1.9|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.9|0.0028
73894699|NCT00567255|147322170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.56|||<|0.001||95.0|-5.19|-3.93|||ANCOVA|||||-3.93|-5.19|<0.001
73894700|NCT00567255|147322171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.16|||<|0.001|TWO_SIDED|95.0|-5.95|-4.38|||ANCOVA|||||-4.38|-5.95|<0.001
73894701|NCT00567255|147322172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.61|||<|0.001||95.0|4.95|8.84|||Regression, Logistic|||||8.84|4.95|<0.001
73894702|NCT00567255|147322173|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.5|||<|0.001|TWO_SIDED|95.0|4.05|7.47|||Regression, Logistic|||||7.47|4.05|<0.001
73894703|NCT00567255|147322174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.001|TWO_SIDED|95.0|3.6|7.98|||Regression, Logistic|||||7.98|3.60|<0.001
73894704|NCT00567255|147322175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.43|||<|0.001|TWO_SIDED|95.0|-4.33|-2.53|||ANCOVA|||||-2.53|-4.33|<0.001
73894705|NCT00567255|147322176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.59|||<|0.001|TWO_SIDED|95.0|1.61|3.57|||ANCOVA|||||3.57|1.61|<0.001
73894706|NCT00567255|147322177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.96||||0.007|TWO_SIDED||||||ANCOVA|||||||0.007
73894707|NCT00567255|147322178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.77|||<|0.001|TWO_SIDED|95.0|2.46|5.09|||ANCOVA|||||5.09|2.46|<0.001
73894708|NCT00567255|147322179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.24||||0.091|TWO_SIDED||||||ANCOVA|||||||0.091
73801911|NCT03349060|147152726|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-2.3|<0.0001
73801912|NCT03349060|147152727|SUPERIORITY||Difference in LS mean|-0.2||||0.6134|TWO_SIDED|95.0|-0.9|0.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.5|-0.9|0.6134
73801913|NCT03349060|147152727|SUPERIORITY||Difference in LS mean|-0.7||||0.0422|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.0|-1.4|0.0422
73801914|NCT03349060|147152727|SUPERIORITY||Difference in LS mean|-0.5||||0.205|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.3|-1.2|0.2050
73801915|NCT03349060|147152727|SUPERIORITY||Difference in LS mean|-1.2||||0.0012|TWO_SIDED|95.0|-1.9|-0.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.5|-1.9|0.0012
73894709|NCT00567255|147322180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.64|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
73894710|NCT00567255|147322181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-1.6|0.85||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.85|-1.60|
73894711|NCT00567255|147322182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.29|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
73894712|NCT00567255|147322183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.23|||||TWO_SIDED|95.0|-9.92|-4.54||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-4.54|-9.92|
73801916|NCT03349060|147152727|SUPERIORITY||Difference in LS mean|-0.4||||0.2657|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.3|-1.2|0.2657
73801917|NCT03349060|147152727|SUPERIORITY||Difference in LS mean|-1.2||||0.0019|TWO_SIDED|95.0|-2.0|-0.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.5|-2.0|0.0019
73801918|NCT03349060|147152727|SUPERIORITY||Difference in LS mean|-0.5||||0.1675|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.2|-1.3|0.1675
73801919|NCT03349060|147152727|SUPERIORITY||Difference in LS mean|-1.0||||0.0085|TWO_SIDED|95.0|-1.8|-0.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-1.8|0.0085
73801920|NCT03349060|147152728|SUPERIORITY||Difference in Percentage|8.8||||0.5539|TWO_SIDED|95.0|-19.6|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.2|-19.6|0.5539
73894713|NCT00567255|147322184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.36|||||TWO_SIDED|95.0|-7.29|-1.44||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-1.44|-7.29|
73894714|NCT00567255|147322185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.7|1.3||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.30|-0.70|
73894715|NCT00567255|147322186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.87|||||TWO_SIDED|95.0|0.16|1.58||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.58|0.16|
73894716|NCT00567255|147322187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.49|0.6||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.60|-0.49|
73894717|NCT00567255|147322188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.56|0.52||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.52|-0.56|
73894718|NCT00567255|147322189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-0.98|0.02||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.02|-0.98|
73894719|NCT03083990|147322193|EQUIVALENCE|Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.|Odds Ratio (OR)|0.9502|||>|0.05|TWO_SIDED|90.0|0.8921|1.012|||ANOVA|||||1.0120|0.8921|>0.05
73801921|NCT03349060|147152728|SUPERIORITY||Difference in Percentage|27.9||||0.0561|TWO_SIDED|95.0|0.8|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.1|0.8|0.0561
73801922|NCT03349060|147152728|SUPERIORITY||Difference in Percentage|-4.9||||0.746|TWO_SIDED|95.0|-33.4|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.7|-33.4|0.7460
73801923|NCT03349060|147152728|SUPERIORITY||Difference in Percentage|0.0||||1|TWO_SIDED|95.0|-28.3|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.3|-28.3|1.0000
73801924|NCT03349060|147152728|SUPERIORITY||Difference in Percentage|20.8||||0.1474|TWO_SIDED|95.0|-4.5|46.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.2|-4.5|0.1474
73801925|NCT03349060|147152728|SUPERIORITY||Difference in Percentage|37.3||||0.0123|TWO_SIDED|95.0|12.1|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||62.5|12.1|0.0123
73801926|NCT03349060|147152728|SUPERIORITY||Difference in Percentage|-0.4||||0.976|TWO_SIDED|95.0|-28.5|27.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.6|-28.5|0.9760
73801927|NCT03349060|147152728|SUPERIORITY||Difference in Percentage|7.8||||0.5965|TWO_SIDED|95.0|-20.4|36.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.1|-20.4|0.5965
73801928|NCT03349060|147152729|SUPERIORITY||Difference in Percentage|24.0||||0.2278|TWO_SIDED|95.0|-9.9|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.0|-9.9|0.2278
73801929|NCT03349060|147152729|SUPERIORITY||Difference in Percentage|35.2||||0.0996|TWO_SIDED|95.0|-2.0|72.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||72.4|-2.0|0.0996
73801930|NCT03349060|147152729|SUPERIORITY||Difference in Percentage|14.5||||0.4449|TWO_SIDED|95.0|-21.6|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||50.6|-21.6|0.4449
73801931|NCT03349060|147152729|SUPERIORITY||Difference in Percentage|16.9||||0.4139|TWO_SIDED|95.0|-21.6|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.5|-21.6|0.4139
73801932|NCT03349060|147152729|SUPERIORITY||Difference in Percentage|-6.7||||0.729|TWO_SIDED|95.0|-40.7|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.4|-40.7|0.7290
73801933|NCT03349060|147152729|SUPERIORITY||Difference in Percentage|8.7||||0.6585|TWO_SIDED|95.0|-27.3|44.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.6|-27.3|0.6585
73801934|NCT03349060|147152729|SUPERIORITY||Difference in Percentage|18.2||||0.3638|TWO_SIDED|95.0|-18.7|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.1|-18.7|0.3638
73801935|NCT03349060|147152729|SUPERIORITY||Difference in Percentage|40.5||||0.055|TWO_SIDED|95.0|2.4|78.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||78.5|2.4|0.0550
73801936|NCT03349060|147152730|SUPERIORITY||Difference in Percentage|-18.8||||0.4036|TWO_SIDED|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.9|-58.4|0.4036
73801937|NCT03349060|147152730|SUPERIORITY||Difference in Percentage|-35.3||||0.158|TWO_SIDED|95.0|-75.9|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-75.9|0.1580
73894720|NCT03083990|147322194|EQUIVALENCE|Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.|Odds Ratio (OR)|0.9483|||>|0.05|TWO_SIDED|90.0|0.8896|1.0108|||ANOVA|||||1.0108|0.8896|>0.05
73894721|NCT03083990|147322195|EQUIVALENCE||Odds Ratio (OR)|0.9749|||>|0.05|TWO_SIDED|90.0|0.9123|1.0418|||ANOVA|||||1.0418|0.9123|>0.05
73894722|NCT00984620|147322205|SUPERIORITY_OR_OTHER||Adjusted percent difference|-1.25||||0.855|TWO_SIDED|95.0|-14.3|11.8|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||11.8|-14.3|0.855
73894723|NCT00984620|147322206|SUPERIORITY_OR_OTHER||Adjusted percent difference|9.02||||0.229|TWO_SIDED|95.0|-5.3|23.3|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||23.3|-5.3|0.229
73894724|NCT00984620|147322207|SUPERIORITY_OR_OTHER||Adjusted percent difference|5.48||||0.417|TWO_SIDED|95.0|-7.3|18.3|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||18.3|-7.3|0.417
73894725|NCT00984620|147322208|SUPERIORITY_OR_OTHER||Adjusted percent difference|2.99||||0.676|TWO_SIDED|95.0|-10.6|16.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||16.6|-10.6|0.676
73894726|NCT00984620|147322209|SUPERIORITY_OR_OTHER||Adjusted percent difference|3.24||||0.588|TWO_SIDED|95.0|-8.1|14.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||14.6|-8.1|0.588
73894727|NCT00984620|147322210|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.78||||0.512|TWO_SIDED|95.0|-9.0|18.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||18.6|-9.0|0.512
73894728|NCT00984620|147322212|SUPERIORITY_OR_OTHER|||||||0.1397||||||Compare 120 MG Faldaprevir 120mg (24 Weeks) over 120 MG Faldaprevir 120mg (12 Weeks) using log-rank test.|Log Rank|||||||0.1397
73894729|NCT00470834|147322231|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Log Rank|||||||0.79
73894730|NCT00470834|147322231|SUPERIORITY_OR_OTHER||Relative Risk|0.94|||||TWO_SIDED|95.0|0.61|1.46|||||The hazard ratio is based on the Cox proportional hazards model.|||1.46|0.61|
73894731|NCT00470834|147322231|SUPERIORITY_OR_OTHER||Relative Risk Reduction|5.62|||||TWO_SIDED|95.0|-46.14|39.05|||||Relative Risk Reduction = 100 \* (1 - Relative Risk).|||39.05|-46.14|
73894732|NCT05871450|147322236|SUPERIORITY|||||||0.05|||||||Regression, Linear|||||||0.05
73894733|NCT00862641|147322237|SUPERIORITY_OR_OTHER|||||||0.1451||95.0|||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the Cochran-Mantel Haenszel(CMH) test stratified by investigative site. Sites with \<15 subjects were pooled.||||||0.1451
73894734|NCT00862641|147322237|SUPERIORITY_OR_OTHER|||||||0.579||95.0|||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the CMH test stratified by investigative site. Sites with less than 15 subjects were pooled.||||||0.5790
73894735|NCT00862641|147322240|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0029
73894736|NCT00862641|147322240|SUPERIORITY_OR_OTHER|||||||0.6189||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.6189
73894737|NCT00862641|147322241|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0015
73894738|NCT00862641|147322241|SUPERIORITY_OR_OTHER|||||||0.4385||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.4385
73894739|NCT00862641|147322242|SUPERIORITY_OR_OTHER|||||||0.0789||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0789
73894740|NCT00862641|147322242|SUPERIORITY_OR_OTHER|||||||0.0258||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0258
73894741|NCT00862641|147322243|SUPERIORITY_OR_OTHER|||||||0.2087||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.2087
73894742|NCT00862641|147322243|SUPERIORITY_OR_OTHER|||||||0.0289||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0289
73894743|NCT00862641|147322244|SUPERIORITY_OR_OTHER|||||||0.9904||95.0|||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."||||0.9904
73894744|NCT00862641|147322244|SUPERIORITY_OR_OTHER|||||||0.8085||95.0|||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."||||0.8085
73894745|NCT02365480|147322248|OTHER||Odds Ratio (OR)|1.91||||0.6|TWO_SIDED|95.0|0.1|36.37|||Fisher Exact|||||36.37|0.10|0.60
73894746|NCT01099449|147322285|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used\>\> to compare the AUC of CIPN sensory subscale between each of the two schedules of\>\> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory\>\> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory\>\> subscale scores from the AUC or incorporate them as a covariate in generalized linear\>\> regression model.||||.73
73894747|NCT01099449|147322285|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used\>\> to compare the AUC of CIPN sensory subscale between each of the two schedules of\>\> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory\>\> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory\>\> subscale scores from the AUC or incorporate them as a covariate in generalized linear\>\> regression model.||||.29
73894748|NCT01099449|147322286|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.054|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.054
73894749|NCT01099449|147322286|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.27|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.27
73894750|NCT01099449|147322287|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.29
73894751|NCT01099449|147322287|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.25|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.25
73894752|NCT01099449|147322290|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Kruskal Wallis Analysis||||||0.89|||||||Kruskal-Wallis|||||||.89
73894753|NCT01099449|147322290|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Kruskal Wallis Analysis||||||0.496|||||||Kruskal-Wallis|||||||.496
73894754|NCT01099449|147322291|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Chi-Squared Analysis||||||0.52|||||||Chi-squared|||||||.52
73894755|NCT01099449|147322291|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Chi-Squared Analysis||||||0.66|||||||Chi-squared|||||||.66
73894756|NCT01798849|147322297|OTHER||Difference in Least-square (LS) Means|-0.5||||0.732|TWO_SIDED|95.0|-3.42|2.43|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.43|-3.42|0.732
73894757|NCT01798849|147322297|OTHER||Difference in LS means|-0.94||||0.531|TWO_SIDED|95.0|-3.94|2.06|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.06|-3.94|0.531
73894758|NCT01798849|147322297|OTHER||Difference in LS Means|-2.88||||0.056|TWO_SIDED|95.0|-5.83|0.08|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.08|-5.83|0.056
73894759|NCT01798849|147322297|OTHER||Difference in LS means|-2.92||||0.063|TWO_SIDED|95.0|-6.0|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.17|-6.00|0.063
73894760|NCT01798849|147322297|OTHER||Difference in LS means|-4.89||||0.002|TWO_SIDED|95.0|-7.79|-1.99|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.99|-7.79|0.002
73894761|NCT01798849|147322297|OTHER||Difference in LS means|-5.31||||0.001|TWO_SIDED|95.0|-8.32|-2.31|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.31|-8.32|0.001
73894762|NCT01798849|147322297|OTHER||Difference in LS means|-5.61||||0.001|TWO_SIDED|95.0|-8.62|-2.6|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.60|-8.62|0.001
73894763|NCT01798849|147322297|OTHER||Difference in LS means|-7.56|||<|0.0001|TWO_SIDED|95.0|-10.5|-4.63|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.63|-10.50|<0.0001
73894764|NCT01798849|147322300|OTHER||Difference in LS means|-2.34||||0.165|TWO_SIDED|95.0|-5.7|1.02|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||1.02|-5.70|0.165
73894765|NCT01798849|147322300|OTHER||Difference in LS means|-3.53||||0.038|TWO_SIDED|95.0|-6.86|-0.21|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.21|-6.86|0.038
73894766|NCT01798849|147322300|OTHER||Difference in LS means|-6.32||||0|TWO_SIDED|95.0|-9.55|-3.1|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.10|-9.55|0.000
73894767|NCT01798849|147322300|OTHER||Difference in LS means|-6.63|||<|0.0001|TWO_SIDED|95.0|-9.35|-3.92|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.92|-9.35|<0.0001
73894768|NCT01798849|147322301|OTHER||Difference in LS means|-2.67||||0.128|TWO_SIDED|95.0|-6.14|0.8|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.80|-6.14|0.128
73894769|NCT01798849|147322301|OTHER||Difference in LS means|-0.76||||0.305|TWO_SIDED|95.0|-2.24|0.72|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.72|-2.24|0.305
73801938|NCT03349060|147152730|SUPERIORITY||Difference in Percentage|-14.2||||0.514|TWO_SIDED|95.0|-53.5|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.1|-53.5|0.5140
73801939|NCT03349060|147152730|SUPERIORITY||Difference in Percentage|-19.8||||0.4149|TWO_SIDED|95.0|-63.3|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.7|-63.3|0.4149
73894770|NCT01798849|147322301|OTHER||Difference in LS means|-2.03||||0.07|TWO_SIDED|95.0|-4.23|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.17|-4.23|0.070
73894771|NCT01798849|147322301|OTHER||Difference in LS means|-2.84||||0.036|TWO_SIDED|95.0|-5.48|-0.19|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.19|-5.48|0.036
73894772|NCT01798849|147322301|OTHER||Difference in LS means|-4.89|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.37|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.37|-6.40|<0.0001
73894773|NCT01798849|147322301|OTHER||Difference in LS means|-5.37|||<|0.0001|TWO_SIDED|95.0|-7.29|-3.46|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.46|-7.29|<0.0001
73894774|NCT01798849|147322301|OTHER||Difference in LS means|-5.68|||<|0.0001|TWO_SIDED|95.0|-6.7|-4.65|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.65|-6.70|<0.0001
73894775|NCT01798849|147322301|OTHER||Difference in LS means|-8.22|||<|0.0001|TWO_SIDED|95.0|-11.95|-4.5|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.50|-11.95|<0.0001
73801940|NCT03349060|147152730|SUPERIORITY||Difference in Percentage|-18.8||||0.4036|TWO_SIDED|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.9|-58.4|0.4036
73894776|NCT01798849|147322302|OTHER||Difference in LS means|-1.77||||0.212|TWO_SIDED|95.0|-4.59|1.05|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||1.05|-4.59|0.212
73894777|NCT01798849|147322302|OTHER||Difference in LS means|3.32||||0.05|TWO_SIDED|95.0|0.0|6.64|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||6.64|0.00|0.050
73894778|NCT01798849|147322302|OTHER||Difference in LS means|2.48||||0.016|TWO_SIDED|95.0|0.49|4.47|||Mixed effect model||Difference in LS means = LS mean MK-8892 minus LS mean placebo|||4.47|0.49|0.016
73894779|NCT01798849|147322302|OTHER||Difference in LS means|5.21||||0.007|TWO_SIDED|95.0|1.51|8.92|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||8.92|1.51|0.007
73894780|NCT01798849|147322302|OTHER||Difference in LS means|7.06||||0.001|TWO_SIDED|95.0|3.03|11.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||11.10|3.03|0.001
73894781|NCT01798849|147322302|OTHER||Difference in LS means|6.62||||0.002|TWO_SIDED|95.0|2.54|10.71|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||10.71|2.54|0.002
73894782|NCT01798849|147322302|OTHER||Difference in LS means|8.11|||<|0.0001|TWO_SIDED|95.0|5.45|10.76|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||10.76|5.45|<0.0001
73894783|NCT01798849|147322302|OTHER||Difference in LS means|14.05|||<|0.0001|TWO_SIDED|95.0|10.54|17.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||17.57|10.54|<0.0001
73894784|NCT01798849|147322303|OTHER||Difference in LS means|-1.66||||0.202|TWO_SIDED|95.0|-4.24|0.93|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.93|-4.24|0.202
73801941|NCT03349060|147152730|SUPERIORITY||Difference in Percentage|-30.7||||0.2092|TWO_SIDED|95.0|-70.9|9.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.6|-70.9|0.2092
73894785|NCT01798849|147322303|OTHER||Difference in LS means|-2.23||||0.115|TWO_SIDED|95.0|-5.03|0.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.57|-5.03|0.115
73894786|NCT01798849|147322303|OTHER||Difference in LS means|-2.75||||0.043|TWO_SIDED|95.0|-5.4|-0.09|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.09|-5.40|0.043
73801942|NCT03349060|147152730|SUPERIORITY||Difference in Percentage|11.9||||0.5982|TWO_SIDED|95.0|-29.1|53.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.0|-29.1|0.5982
73801943|NCT03349060|147152730|SUPERIORITY||Difference in Percentage|4.2||||0.8647|TWO_SIDED|95.0|-36.3|44.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.7|-36.3|0.8647
73801944|NCT03349060|147152731|SUPERIORITY||Difference in Percentage|-78.6||||0.0546|TWO_SIDED|95.0|-117.5|-39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||-39.6|-117.5|0.0546
73801945|NCT03349060|147152731|SUPERIORITY||Difference in Percentage|-27.9||||0.3573|TWO_SIDED|95.0|-62.5|6.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.7|-62.5|0.3573
73801946|NCT03349060|147152731|SUPERIORITY||Difference in Percentage|-3.6||||0.9219|TWO_SIDED|95.0|-55.6|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.5|-55.6|0.9219
73801947|NCT03349060|147152731|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
73801948|NCT03349060|147152731|SUPERIORITY||Difference in Percentage|-25.0||||0.5408|TWO_SIDED|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.0|-77.0|0.5408
73801949|NCT03349060|147152731|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
73894787|NCT01798849|147322303|OTHER||Difference in LS means|-0.19||||0.901|TWO_SIDED|95.0|-3.22|2.84|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.84|-3.22|0.901
73894788|NCT01798849|147322303|OTHER||Mixed effect model|-4.15||||0.002|TWO_SIDED|95.0|-6.74|-1.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|||-1.57|-6.74|0.002
73894789|NCT01798849|147322303|OTHER||Difference in LS means|-3.77||||0.008|TWO_SIDED|95.0|-6.48|-1.06|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.06|-6.48|0.008
73801950|NCT03349060|147152731|SUPERIORITY||Difference in Percentage|-25.0||||0.5408|TWO_SIDED|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.0|-77.0|0.5408
73801951|NCT03349060|147152731|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
73801952|NCT03349060|147152732|SUPERIORITY||Difference in LS mean|-2.8||||0.0006|TWO_SIDED|95.0|-4.4|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.2|-4.4|0.0006
73801953|NCT03349060|147152732|SUPERIORITY||Difference in LS mean|-6.3|||<|0.0001|TWO_SIDED|95.0|-7.9|-4.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.7|-7.9|<0.0001
73801954|NCT03349060|147152732|SUPERIORITY||Difference in LS mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.6|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.0|-5.6|<0.0001
73894790|NCT01798849|147322303|OTHER||Difference in LS means|-1.77||||0.201|TWO_SIDED|95.0|-4.51|0.98|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.98|-4.51|0.201
73894791|NCT01798849|147322303|OTHER||Difference in LS means|-4.74||||0.001|TWO_SIDED|95.0|-7.37|-2.11|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.11|-7.37|0.001
73894792|NCT01798849|147322304|OTHER||Difference in LS means|-2.53||||0.042|TWO_SIDED|95.0|-4.97|-0.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.10|-4.97|0.042
73801955|NCT03349060|147152732|SUPERIORITY||Difference in LS mean|-8.4|||<|0.0001|TWO_SIDED|95.0|-10.2|-6.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-6.6|-10.2|<0.0001
73894793|NCT01798849|147322304|OTHER||Difference in LS means|-3.29||||0.01|TWO_SIDED|95.0|-5.71|-0.88|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.88|-5.71|0.010
73894794|NCT01798849|147322304|OTHER||Difference in LS means|-6.42|||<|0.0001|TWO_SIDED|95.0|-8.94|-3.89|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.89|-8.94|<0.0001
73801956|NCT03349060|147152732|SUPERIORITY||Difference in LS mean|-2.7||||0.0096|TWO_SIDED|95.0|-4.7|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-4.7|0.0096
73801957|NCT03349060|147152732|SUPERIORITY||Difference in LS mean|-7.2|||<|0.0001|TWO_SIDED|95.0|-9.3|-5.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.2|-9.3|<0.0001
73801958|NCT03349060|147152732|SUPERIORITY||Difference in LS mean|-3.1||||0.0049|TWO_SIDED|95.0|-5.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-5.2|0.0049
73801959|NCT03349060|147152732|SUPERIORITY||Difference in LS mean|-6.9|||<|0.0001|TWO_SIDED|95.0|-9.0|-4.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.7|-9.0|<0.0001
73801960|NCT03349060|147152733|SUPERIORITY||Difference in LS mean|-0.4||||0.002|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.1|-0.6|0.0020
73801961|NCT03349060|147152733|SUPERIORITY||Difference in LS mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.0|<0.0001
73801962|NCT03349060|147152733|SUPERIORITY||Difference in LS mean|-0.5||||0.0011|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.7|0.0011
73801963|NCT03349060|147152733|SUPERIORITY||Difference in LS mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-1.2|<0.0001
73801964|NCT03349060|147152733|SUPERIORITY||Difference in LS mean|-0.5||||0.002|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.8|0.0020
73801965|NCT03349060|147152733|SUPERIORITY||Difference in LS mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.2|<0.0001
73801966|NCT03349060|147152733|SUPERIORITY||Difference in LS mean|-0.5||||0.0014|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.8|0.0014
73894795|NCT01798849|147322304|OTHER||Difference in LS means|-8.28|||<|0.0001|TWO_SIDED|95.0|-11.32|-5.25|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-5.25|-11.32|<0.0001
73801967|NCT03349060|147152733|SUPERIORITY||Difference in LS mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.3|<0.0001
73801968|NCT03349060|147152734|SUPERIORITY||Difference in Percentage|6.0||||0.0575|TWO_SIDED|95.0|0.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|0.3|0.0575
73801969|NCT03349060|147152734|SUPERIORITY||Difference in Percentage|18.1||||0.0002|TWO_SIDED|95.0|10.7|25.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.5|10.7|0.0002
73894796|NCT01798849|147322305|OTHER||Difference in LS means|0.54||||0.638|TWO_SIDED|95.0|-1.8|2.87|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.87|-1.80|0.638
73801970|NCT03349060|147152734|SUPERIORITY||Difference in Percentage|9.2||||0.0411|TWO_SIDED|95.0|1.3|17.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.1|1.3|0.0411
73801971|NCT03349060|147152734|SUPERIORITY||Difference in Percentage|26.2|||<|0.0001|TWO_SIDED|95.0|16.9|35.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.5|16.9|<0.0001
73801972|NCT03349060|147152734|SUPERIORITY||Difference in Percentage|8.9||||0.0781|TWO_SIDED|95.0|-0.1|18.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.0|-0.1|0.0781
73801973|NCT03349060|147152734|SUPERIORITY||Difference in Percentage|26.2|||<|0.0001|TWO_SIDED|95.0|16.2|36.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.3|16.2|<0.0001
73801974|NCT03349060|147152734|SUPERIORITY||Difference in Percentage|14.2||||0.0075|TWO_SIDED|95.0|5.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.2|5.3|0.0075
73801975|NCT03349060|147152734|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|19.6|38.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.9|19.6|<0.0001
73801976|NCT03349060|147152735|SUPERIORITY||Difference in LS mean|0.034||||0.0453|TWO_SIDED|95.0|0.001|0.066|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.066|0.001|0.0453
73801977|NCT03349060|147152735|SUPERIORITY||Difference in LS mean|0.068|||<|0.0001|TWO_SIDED|95.0|0.036|0.101|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.101|0.036|<0.0001
73801978|NCT03349060|147152735|SUPERIORITY||Difference in LS mean|0.025||||0.1821|TWO_SIDED|95.0|-0.012|0.062|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.062|-0.012|0.1821
73801979|NCT03349060|147152735|SUPERIORITY||Difference in LS mean|0.055||||0.0038|TWO_SIDED|95.0|0.018|0.092|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.092|0.018|0.0038
73801980|NCT03349060|147152735|SUPERIORITY||Difference in LS mean|0.048||||0.0241|TWO_SIDED|95.0|0.006|0.09|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.090|0.006|0.0241
73801981|NCT03349060|147152735|SUPERIORITY||Difference in LS mean|0.093|||<|0.0001|TWO_SIDED|95.0|0.051|0.134|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.134|0.051|<0.0001
73801982|NCT03349060|147152735|SUPERIORITY||Difference in LS mean|0.044||||0.0461|TWO_SIDED|95.0|0.001|0.087|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.087|0.001|0.0461
73801983|NCT03349060|147152735|SUPERIORITY||Difference in LS mean|0.064||||0.0037|TWO_SIDED|95.0|0.021|0.107|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.107|0.021|0.0037
73801984|NCT03349060|147152736|SUPERIORITY||Difference in LS mean|4.548||||0.0319|TWO_SIDED|95.0|0.397|8.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||8.700|0.397|0.0319
73801985|NCT03349060|147152736|SUPERIORITY||Difference in LS mean|8.659|||<|0.0001|TWO_SIDED|95.0|4.496|12.822|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||12.822|4.496|<0.0001
73801986|NCT03349060|147152736|SUPERIORITY||Difference in LS mean|4.361||||0.0702|TWO_SIDED|95.0|-0.362|9.084|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||9.084|-0.362|0.0702
73801987|NCT03349060|147152736|SUPERIORITY||Difference in LS mean|10.085|||<|0.0001|TWO_SIDED|95.0|5.349|14.821|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||14.821|5.349|<0.0001
73801988|NCT03349060|147152736|SUPERIORITY||Difference in LS mean|6.045||||0.03|TWO_SIDED|95.0|0.589|11.501|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||11.501|0.589|0.0300
73801989|NCT03349060|147152736|SUPERIORITY||Difference in LS mean|9.803||||0.0005|TWO_SIDED|95.0|4.368|15.237|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||15.237|4.368|0.0005
73801990|NCT03349060|147152736|SUPERIORITY||Difference in LS mean|7.569||||0.0067|TWO_SIDED|95.0|2.119|13.019|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||13.019|2.119|0.0067
73801991|NCT03349060|147152736|SUPERIORITY||Difference in LS mean|9.374||||0.0008|TWO_SIDED|95.0|3.933|14.815|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||14.815|3.933|0.0008
73801992|NCT03349060|147152737|SUPERIORITY||Difference in LS mean|-0.004||||0.9568|TWO_SIDED|95.0|-0.137|0.13|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.130|-0.137|0.9568
73801993|NCT03349060|147152737|SUPERIORITY||Difference in LS mean|0.09||||0.1782|TWO_SIDED|95.0|-0.042|0.223|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.223|-0.042|0.1782
73801994|NCT03349060|147152737|SUPERIORITY||Difference in LS mean|0.174||||0.0491|TWO_SIDED|95.0|0.001|0.347|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.347|0.001|0.0491
73801995|NCT03349060|147152737|SUPERIORITY||Difference in LS mean|0.284||||0.0015|TWO_SIDED|95.0|0.112|0.456|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.456|0.112|0.0015
73801996|NCT03349060|147152737|SUPERIORITY||Difference in LS mean|0.004||||0.9638|TWO_SIDED|95.0|-0.185|0.194|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.194|-0.185|0.9638
73801997|NCT03349060|147152737|SUPERIORITY||Difference in LS mean|0.08||||0.4016|TWO_SIDED|95.0|-0.109|0.27|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.270|-0.109|0.4016
73801998|NCT03349060|147152737|SUPERIORITY||Difference in LS mean|0.007||||0.9429|TWO_SIDED|95.0|-0.184|0.198|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.198|-0.184|0.9429
73801999|NCT03349060|147152737|SUPERIORITY||Difference in LS mean|0.062||||0.5212|TWO_SIDED|95.0|-0.13|0.254|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.254|-0.130|0.5212
73802000|NCT03349060|147152738|SUPERIORITY||Difference in LS mean|2.131||||0.6467|TWO_SIDED|95.0|-7.095|11.358|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||11.358|-7.095|0.6467
73802001|NCT03349060|147152738|SUPERIORITY||Difference in LS mean|11.549||||0.0147|TWO_SIDED|95.0|2.338|20.761|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||20.761|2.338|0.0147
73802002|NCT03349060|147152738|SUPERIORITY||Difference in LS mean|6.853||||0.1894|TWO_SIDED|95.0|-3.453|17.159|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||17.159|-3.453|0.1894
73802003|NCT03349060|147152738|SUPERIORITY||Difference in LS mean|16.99||||0.0015|TWO_SIDED|95.0|6.699|27.281|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||27.281|6.699|0.0015
73802004|NCT03349060|147152738|SUPERIORITY||Difference in LS mean|8.672||||0.1267|TWO_SIDED|95.0|-2.518|19.862|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||19.862|-2.518|0.1267
73802005|NCT03349060|147152738|SUPERIORITY||Difference in LS mean|9.354||||0.1009|TWO_SIDED|95.0|-1.866|20.573|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||20.573|-1.866|0.1009
73894797|NCT01798849|147322305|OTHER||Difference in LS means|0.72||||0.616|TWO_SIDED|95.0|-2.2|3.63|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||3.63|-2.20|0.616
73894798|NCT01798849|147322305|OTHER||Difference in LS means|2.33||||0.041|TWO_SIDED|95.0|0.11|4.56|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||4.56|0.11|0.041
73802006|NCT03349060|147152738|SUPERIORITY||Difference in LS mean|6.071||||0.1915|TWO_SIDED|95.0|-3.107|15.249|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||15.249|-3.107|0.1915
73802007|NCT03349060|147152738|SUPERIORITY||Difference in LS mean|12.948||||0.0064|TWO_SIDED|95.0|3.754|22.143|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||22.143|3.754|0.0064
73802008|NCT03349060|147152739|SUPERIORITY||Difference in LS mean|3.6||||0.0102|TWO_SIDED|95.0|0.9|6.4||Analysis of covariance (ANCOVA) model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||6.4|0.9|0.0102
73802009|NCT03349060|147152739|SUPERIORITY||Difference in LS mean|4.5||||0.0013|TWO_SIDED|95.0|1.8|7.3||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||7.3|1.8|0.0013
73802010|NCT03349060|147152740|SUPERIORITY||Difference in LS mean|1.0||||0.5241|TWO_SIDED|95.0|-2.1|4.2||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.2|-2.1|0.5241
73802011|NCT03349060|147152740|SUPERIORITY||Difference in LS mean|0.9||||0.5821|TWO_SIDED|95.0|-2.3|4.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.1|-2.3|0.5821
73802012|NCT03349060|147152741|SUPERIORITY||Difference in LS mean|3.8||||0.0013|TWO_SIDED|95.0|1.5|6.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||6.1|1.5|0.0013
73802013|NCT03349060|147152741|SUPERIORITY||Difference in LS mean|4.7|||<|0.0001|TWO_SIDED|95.0|2.4|7.0||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||7.0|2.4|<0.0001
73894799|NCT01798849|147322305|OTHER||Difference in LS means|9.14|||<|0.0001|TWO_SIDED|95.0|6.98|11.3|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||11.30|6.98|<0.0001
73894800|NCT01798849|147322306|OTHER||Difference in LS means|-0.65||||0.677|TWO_SIDED|95.0|-3.81|2.52|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.52|-3.81|0.677
73894801|NCT01798849|147322306|OTHER||Difference in LS means|-0.92||||0.554|TWO_SIDED|95.0|-4.08|2.24|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.24|-4.08|0.554
73802014|NCT03349060|147152742|SUPERIORITY||Difference in LS mean|1.7||||0.2256|TWO_SIDED|95.0|-1.0|4.4||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.4|-1.0|0.2256
73802015|NCT03349060|147152742|SUPERIORITY||Difference in LS mean|3.0||||0.0275|TWO_SIDED|95.0|0.3|5.8||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||5.8|0.3|0.0275
73802016|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|3.9|||<|0.0001|TWO_SIDED|95.0|2.0|7.7||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||7.7|2.0|<0.0001
73802017|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.3|||<|0.0001|TWO_SIDED|95.0|0.1|0.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.6|0.1|<0.0001
73802018|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|1.5||||0.6334|TWO_SIDED|95.0|0.8|3.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.0|0.8|0.6334
73802019|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.6||||0.8065|TWO_SIDED|95.0|0.2|1.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.6|0.2|0.8065
73802020|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|10.0|||<|0.0001|TWO_SIDED|95.0|3.8|26.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||26.6|3.8|<0.0001
73802021|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.3|0.0|<0.0001
73802022|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.3|0.0|<0.0001
73802023|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
73802024|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.4||||0.0011|TWO_SIDED|95.0|0.2|0.8||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.8|0.2|0.0011
73802025|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
73802026|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|2.6||||0.0718|TWO_SIDED|95.0|1.0|6.9||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||6.9|1.0|0.0718
73802027|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.4||||0.0593|TWO_SIDED|95.0|0.1|1.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.0|0.1|0.0593
73802028|NCT02861586|147152744|SUPERIORITY||Gemetric mean ratio|0.4||||0.0593|TWO_SIDED|95.0|0.1|1.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.0|0.1|0.0593
73802029|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|5.2|||<|0.0001|TWO_SIDED|95.0|2.6|10.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||10.4|2.6|<0.0001
73802030|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|2.2||||0.2005|TWO_SIDED|95.0|0.8|5.7||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||5.7|0.8|0.2005
73802031|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|35.0|||<|0.0001|TWO_SIDED|95.0|13.1|93.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||93.1|13.1|<0.0001
73802032|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
73802033|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.0|||<|0.0001|TWO_SIDED|0.0|0.0|0.1|||ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
73802034|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.4||||0.1138|TWO_SIDED|95.0|0.2|1.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.1|0.2|0.1138
73802035|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|6.7|||<|0.0001|TWO_SIDED|95.0|2.5|18.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||18.1|2.5|<0.0001
73802036|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
73802037|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
73802038|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|16.0|||<|0.0001|TWO_SIDED|95.0|4.9|52.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||52.4|4.9|<0.0001
73802039|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.2|0.0|<0.0001
73894802|NCT01798849|147322306|OTHER||Difference in LS means|-2.29||||0.137|TWO_SIDED|95.0|-5.35|0.78|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.78|-5.35|0.137
73802040|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.2|0.0|<0.0001
73802041|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.3|0.3|1.0000
73802042|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.3|0.3|1.0000
73802043|NCT02861586|147152744|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.2|0.3|1.0000
73802044|NCT02861586|147152753|SUPERIORITY||Geometric mean ratio|0.9||||0.9775|TWO_SIDED|95.0|0.4|2.0|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||2.0|0.4|0.9775
73802045|NCT02861586|147152753|SUPERIORITY||Geometric mean ratio|1.3||||0.8366|TWO_SIDED|95.0|0.6|3.1|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.1|0.6|0.8366
73802046|NCT02861586|147152753|SUPERIORITY||Geometric mean ratio|1.5||||0.5625|TWO_SIDED|95.0|0.7|3.6|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.6|0.7|0.5625
73802047|NCT02861586|147152753|SUPERIORITY||Geometric mean ratio|1.5||||0.5924|TWO_SIDED|95.0|0.6|3.5|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.5|0.6|0.5924
73802048|NCT02861586|147152753|SUPERIORITY||Geometric mean ratio|1.8||||0.3122|TWO_SIDED|95.0|0.8|4.1|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||4.1|0.8|0.3122
73802049|NCT02861586|147152753|SUPERIORITY||Geometric mean ratio|1.2||||0.9665|TWO_SIDED|95.0|0.5|2.8|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||2.8|0.5|0.9665
73802050|NCT03985800|147152767|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|1.26||||0.53||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 1.26 with two degrees of freedom.||Null hypothesis: The trajectory of IBD complexity score does not differ by treatment group.||||0.53
73802051|NCT03985800|147152767|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.14||||0.57||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*age interaction term is 1.14 with two degrees of freedom.||Aim 2b., moderation by age. Null hypothesis: Age does not moderate the trajectory of complexity score by treatment group.||||0.57
73802052|NCT03985800|147152767|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|0.08||||0.96||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*diagnosis interaction term is 0.08 with two degrees of freedom.||Aim 2b., moderation by diagnosis. Null hypothesis: Diagnosis does not moderate the trajectory of complexity score by treatment group.||||0.96
73802053|NCT03985800|147152767|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|6.41||||0.17||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 6.41 with two degrees of freedom.||Aim 2b., moderation by site. Null hypothesis: Site does not moderate the trajectory of complexity score by treatment group.||||0.17
73802054|NCT03985800|147152767|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|2.6||||0.27||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 2.6 with two degrees of freedom.||Aim 2b., moderation by eHealth literacy. Null hypothesis: eHealth literacy does not moderate the trajectory of complexity score by treatment group.||||0.27
73802055|NCT03985800|147152768|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|0.21||||0.9||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 0.21 with two degrees of freedom.||Aim 1. The trajectory of PHQ-ADS does not differ by treatment group.||||0.90
73802056|NCT03985800|147152768|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.21||||0.55||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|||Aim 2a, moderation by disease activity. Null hypothesis: Disease activity does not moderate the trajectory of behavioral health score by treatment group.||||0.55
73802057|NCT03985800|147152768|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.37||||0.5||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*age interaction term is 1.37 with two degrees of freedom.||Aim 2b, moderation by age. Null hypothesis: Age does not moderate the trajectory of behavioral health score by treatment group.||||0.50
73802058|NCT03985800|147152768|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|5.16||||0.08||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*diagnosis interaction term is 5.16 with two degrees of freedom.||Aim 2b, moderation by diagnosis. Null hypothesis: Diagnosis does not moderate the trajectory of behavioral health score by treatment group.||||0.08
73894803|NCT01798849|147322306|OTHER||Difference in LS means|-3.78||||0.006|TWO_SIDED|95.0|-6.37|-1.19|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.19|-6.37|0.006
73894804|NCT02428478|147322327|OTHER|||||||0.01||||||P\<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Tonic analysis||||0.01
73802059|NCT03985800|147152768|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|0.11||||1||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 0.11 with two degrees of freedom.||Aim 2b, moderation by site. Null hypothesis: Site does not moderate the trajectory of behavioral health score by treatment group.||||1.0
73802060|NCT03985800|147152768|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|3.23||||0.2||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*eHealth literacy interaction term is 3.23 with two degrees of freedom.||Aim 2b, moderation by eHealth literacy. Null hypothesis: eHealth literacy does not moderate the trajectory of behavioral health score by treatment group.||||0.20
73802061|NCT03985800|147152769|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|3.09||||0.53||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 3.09 with two degrees of freedom.||Null hypothesis: The trajectory of functional impairment does not differ by treatment group.||||0.53
73802062|NCT03985800|147152770|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|6.01||||0.05||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 6.01 with two degrees of freedom.||Null hypothesis: The trajectory of IBD-IBS symptom severity does not differ by treatment group.||||0.05
73802063|NCT03985800|147152771|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|4.14||||0.13||||||The threshold for statistical significance was .05.|Mixed Models Analysis|For hospitalizations, the Chi-squared statistic for the group\*time interaction term is 4.14 with two degrees of freedom||Null hypothesis: The trajectory of hospitalizations does not differ by treatment group.||||0.13
73802064|NCT03985800|147152771|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|0.82||||0.67||||||The threshold for statistical significance was .05.|Mixed Models Analysis|For ED visits, the Chi-squared statistic for the group\*time interaction term is 0.82 with two degrees of freedom.||Null hypothesis: The trajectory of ED visits does not differ by treatment group.||||0.67
73802065|NCT03985800|147152772|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|1.98||||0.37||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 1.98 with two degrees of freedom.||Null hypothesis: The trajectory of self-efficacy does not differ by treatment group.||||0.37
73802066|NCT03985800|147152773|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|5.57||||0.06||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 5.57 with two degrees of freedom.||Null hypothesis: The trajectory of quality of life does not differ by treatment group.||||0.06
73802067|NCT04281485|147152774|SUPERIORITY||Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.78|=|0.9116|TWO_SIDED|95.0|-1.46|1.64|||Mixed Models Analysis||||The Mixed Model Repeated Measures (MMRM) model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|1.64|-1.46|=0.9116
73802068|NCT04281485|147152775|SUPERIORITY||Least Square Mean Difference|85.75|STANDARD_ERROR_OF_MEAN|17.17|=|0.0002|TWO_SIDED|95.0|49.15|122.35|||ANCOVA|The ANCOVA model contained treatment group (categorical variable) and screening age (continuous variable).||||122.35|49.15|=0.0002
73802069|NCT04281485|147152776|SUPERIORITY||Least Square Mean Difference|51.46|STANDARD_ERROR_OF_MEAN|9.49|<|0.0001|TWO_SIDED|95.0|31.43|71.49|||ANCOVA|The ANCOVA model contained treatment group (categorical variable) and screening age (continuous variable).||||71.49|31.43|<0.0001
73802070|NCT04281485|147152777|SUPERIORITY||Geometric Ratio of LS Means|0.64|||=|0.0002|TWO_SIDED|95.0|0.5|0.81|||Mixed Models Analysis||||MMRM approach for log transformed data including visits through Week 52 where serum CK concentration was assessed with fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction, and with additional fixed effects for natural log of baseline (continuous variable), screening age covariate (continuous variable), natural log of baseline by visit interaction, and screening age covariate by visit interaction with an unstructured variance-covariance matrix.|0.81|0.50|=0.0002
73802071|NCT04281485|147152778|SUPERIORITY||Odds Ratio (OR)|1.73|||=|0.2784|TWO_SIDED|95.0|0.64|4.62|||Binomial regression||||The generalized mixed linear model assumed a binomial distribution with logit link \& contains fixed effects for treatment group (categorical variable) \& screening age (continuous variable).|4.62|0.64|=0.2784
73802072|NCT04281485|147152779|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.5437|TWO_SIDED|95.0|0.63|1.28|||Binomial Regression||||The generalized mixed linear model assumed a binomial distribution with a logit link and contained fixed effects for treatment group (categorical variable) and screening age (continuous variable).|1.28|0.63|=0.5437
73802073|NCT04281485|147152780|SUPERIORITY||Least Square Mean Difference|-0.079|STANDARD_ERROR_OF_MEAN|0.082|=|0.3343|TWO_SIDED|95.0|-0.242|0.083|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|0.083|-0.242|=0.3343
73802074|NCT04281485|147152781|SUPERIORITY||Least Square Mean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.024|=|0.8826|TWO_SIDED|95.0|-0.052|0.045|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|0.045|-0.052|=0.8826
73802075|NCT04281485|147152782|SUPERIORITY||Least Square Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.63|=|0.219|TWO_SIDED|95.0|-1.22|5.24|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|5.24|-1.22|=0.2190
73802076|NCT04281485|147152783|SUPERIORITY||Least Square Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|2.96|=|0.7096||95.0|-4.79|7.0|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|7.00|-4.79|=0.7096
73802077|NCT00127231|147152784|EQUIVALENCE||Odds Ratio (OR)|0.42|||<|0.005|TWO_SIDED|95.0|0.23|0.75|||Mixed Models Analysis|||Drinking frequency was analyzed using a generalized binomial mixed-effects model with the logit link function and a random intercept. The use of a binomial distribution was indicated for this analysis because the outcome was assessed using a 90-day TLFB interview, which has a cap at 90 days.||0.75|0.23|<0.005
73802078|NCT03096314|147152789|SUPERIORITY|||||||0.26|||||||Generalized linear model|||||||0.26
73802079|NCT03096314|147152790|SUPERIORITY||Risk Difference (RD)|4.3|||||TWO_SIDED|95.0|-0.1|8.6||||||||8.6|-0.1|
73802080|NCT03096314|147152791|SUPERIORITY||Risk Difference (RD)|3.7|||||TWO_SIDED|95.0|-0.5|8.0||||||||8.0|-0.5|
73802081|NCT03096314|147152792|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-5.4|6.0||||||||6.0|-5.4|
73802082|NCT03096314|147152793|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-2.7|0.0||||||||0.0|-2.7|
73802083|NCT03096314|147152794|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-4.8|0.4||||||||0.4|-4.8|
73802084|NCT03096314|147152795|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.1|0.5||||||||0.5|-2.1|
73802085|NCT03096314|147152796|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||||0.1|0|
73802086|NCT03096314|147152797|SUPERIORITY||Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-2.1|3.6||||||||3.6|-2.1|
73802087|NCT03096314|147152798|SUPERIORITY||Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|-22.0|34.9||||||Mild ARDS||34.9|-22.0|
73802088|NCT03096314|147152798|SUPERIORITY||Risk Difference (RD)|-25.6|||||TWO_SIDED|95.0|-56.3|5.1||||||Moderate ARDS||5.1|-56.3|
73802089|NCT03096314|147152798|SUPERIORITY||Risk Difference (RD)|19.1|||||TWO_SIDED|95.0|-2.9|41.1||||||Severe ARDS||41.1|-2.9|
73802090|NCT03096314|147152799|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-7.3|5.0||||||No AKI||5.0|-7.3|
73802091|NCT03096314|147152799|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-5.6|3.4||||||Mild AKI||3.4|-5.6|
73802092|NCT03096314|147152799|SUPERIORITY||Risk Difference (RD)|-0.6|||||TWO_SIDED|95.0|-4.4|3.2||||||Moderate AKI||3.2|-4.4|
73802093|NCT03096314|147152799|SUPERIORITY||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-1.7|7.3||||||Severe AKI||7.3|-1.7|
73802094|NCT03096314|147152800|SUPERIORITY||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-1.9|2.9||||||||2.9|-1.9|
73802095|NCT03096314|147152801|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
73802096|NCT03096314|147152802|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-4.4|5.1||||||||5.1|-4.4|
73802097|NCT03096314|147152803|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
73802098|NCT03096314|147152804|SUPERIORITY||Mean Difference (Final Values)|35.5|||||TWO_SIDED|95.0|31.5|39.6||||||||39.6|31.5|
73802099|NCT03096314|147152805|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
73802100|NCT03096314|147152806|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
73802101|NCT03096314|147152807|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
73802102|NCT03096314|147152808|SUPERIORITY|||||||0.25|||||||Fisher Exact|||||||0.25
73802103|NCT03096314|147152809|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
73802104|NCT03096314|147152810|SUPERIORITY|||||||0.24|||||||Chi-squared|||||||0.24
73802105|NCT00191477|147152868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.946||||0.777||95.0|0.643|1.392||Only 87 recurrences and 7 deaths were documented at planned end of follow-up. The study was stopped early for futility reasons based on an interim analysis using pre-defined stopping boundaries for the hazard ratio (HR) of RFS.|Log Rank|||Sample-size calculation based on estimated 1-year recurrence-free survival (RFS) rates of 63% (gemcitabine) and 50% (placebo). 191 critical events were required to detect a difference in RFS (80% power, log-rank test, alpha=0.050). Sample size of 328 patients with clinical evidence of superficial bladder cancer needed to observe these 191 events within a 24-month follow-up period, assuming 246 of these patients would receive instillation and have histopathological diagnosis of pTa/pT1(G1-3/Gx).||1.392|0.643|0.777
73802106|NCT01108718|147152926|SUPERIORITY_OR_OTHER||Rate of Preference|0.45|STANDARD_DEVIATION|0.5|>|0.1|TWO_SIDED|95.0|0.43|0.47|||McNemar||Rate of preference refers specifically to Tempur-Pedic Mattress.|h0: Rate Preference Tempur-pedic mattress = Rate Preference control mattress h1: Rate Preference Tempur-pedic mattress = Rate Preference control mattress||.47|.43|>0.1
73802107|NCT03380429|147152927|SUPERIORITY||Mean Difference (Final Values)|12.0|||<|0.001|TWO_SIDED|95.0|5.2|18.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||18.8|5.2|<0.001
73802108|NCT03380429|147152928|OTHER||Mean Difference (Final Values)|8.2||||0.016|TWO_SIDED|95.0|1.6|14.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||14.9|1.6|0.016
73802109|NCT03380429|147152928|OTHER||Mean Difference (Final Values)|9.3||||0.006|TWO_SIDED|95.0|2.7|16.0||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||16.0|2.7|0.006
73802110|NCT03380429|147152928|OTHER||Mean Difference (Final Values)|8.1||||0.018|TWO_SIDED|95.0|1.4|14.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||14.8|1.4|0.018
73802111|NCT03380429|147152929|OTHER||Mean Difference (Final Values)|9.3||||0.003|TWO_SIDED|95.0|3.2|15.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||15.3|3.2|0.003
73802112|NCT03380429|147152929|OTHER||Mean Difference (Final Values)|7.7||||0.011|TWO_SIDED|95.0|1.8|13.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||13.7|1.8|0.011
73802113|NCT03380429|147152929|OTHER||Mean Difference (Final Values)|5.5||||0.066|TWO_SIDED|95.0|-0.4|11.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||11.4|-0.4|0.066
73802114|NCT03380429|147152929|OTHER||Mean Difference (Final Values)|2.8||||0.359|TWO_SIDED|95.0|-3.1|8.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||8.7|-3.1|0.359
73802115|NCT03380429|147152930|OTHER||Mean Difference (Final Values)|9.7||||0.004|TWO_SIDED|95.0|3.1|16.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||16.3|3.1|0.004
73802116|NCT03380429|147152930|OTHER||Mean Difference (Final Values)|7.1||||0.032|TWO_SIDED|95.0|0.6|13.5||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||13.5|0.6|0.032
73802117|NCT03380429|147152930|OTHER||Mean Difference (Final Values)|5.9||||0.07|TWO_SIDED|95.0|-0.5|12.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||12.4|-0.5|0.070
73802118|NCT03380429|147152930|OTHER||Mean Difference (Final Values)|3.4||||0.294|TWO_SIDED|95.0|-3.0|9.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||9.9|-3.0|0.294
73802119|NCT03380429|147152931|OTHER||Mean Difference (Final Values)|4.8||||0.118|TWO_SIDED|95.0|-1.2|10.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||10.8|-1.2|0.118
73802120|NCT03380429|147152931|OTHER||Mean Difference (Final Values)|4.8||||0.105|TWO_SIDED|95.0|-1.0|10.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||10.7|-1.0|0.105
73802121|NCT03380429|147152931|OTHER||Mean Difference (Final Values)|9.2||||0.002|TWO_SIDED|95.0|3.3|15.1||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||15.1|3.3|0.002
73802122|NCT03380429|147152931|OTHER||Mean Difference (Final Values)|7.3||||0.015|TWO_SIDED|95.0|1.5|13.2||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||13.2|1.5|0.015
73802123|NCT03380429|147152933|OTHER||Mean Difference (Net)|-0.5||||0.4|TWO_SIDED|95.0|-1.6|0.6||p-value was calculated using Mixed Model Repeated Measures (MMRM).|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||0.6|-1.6|0.400
73802124|NCT03380429|147152933|OTHER||Mean Difference (Net)|0.4||||0.441|TWO_SIDED|95.0|-0.7|1.5||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.5|-0.7|0.441
73802125|NCT03380429|147152933|OTHER||Mean Difference (Net)|0.8||||0.164|TWO_SIDED|95.0|-0.3|1.9||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.9|-0.3|0.164
73802126|NCT03380429|147152933|OTHER||Mean Difference (Net)|0.3||||0.661|TWO_SIDED|95.0|-0.9|1.4||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.4|-0.9|0.661
73894805|NCT02428478|147322327|OTHER|||||||0.38||||||P\<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Phasic analysis||||0.38
73802127|NCT03380429|147152934|OTHER||Odds Ratio (OR)|0.75||||0.385|TWO_SIDED|95.0|0.39|1.44||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.44|0.39|0.385
73802128|NCT03380429|147152934|OTHER||Odds Ratio (OR)|1.24||||0.517|TWO_SIDED|95.0|0.64|2.42||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.42|0.64|0.517
73802129|NCT03380429|147152934|OTHER||Odds Ratio (OR)|0.97||||0.921|TWO_SIDED|95.0|0.51|1.85||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.85|0.51|0.921
73802130|NCT03380429|147152934|OTHER||Odds Ratio (OR)|0.72||||0.321|TWO_SIDED|95.0|0.38|1.38||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.38|0.38|0.321
73802131|NCT03380429|147152935|OTHER||Odds Ratio (OR)|1.04||||0.911|TWO_SIDED|95.0|0.54|1.98||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.98|0.54|0.911
73802132|NCT03380429|147152935|OTHER||Odds Ratio (OR)|1.33||||0.383|TWO_SIDED|95.0|0.7|2.54||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.54|0.70|0.383
73802133|NCT03380429|147152935|OTHER||Odds Ratio (OR)|1.08||||0.814|TWO_SIDED|95.0|0.57|2.04||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.04|0.57|0.814
73802134|NCT03380429|147152935|OTHER||Odds Ratio (OR)|1.01||||0.986|TWO_SIDED|95.0|0.53|1.89||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.89|0.53|0.986
73802135|NCT03380429|147152936|OTHER||Odds Ratio (OR)|0.93||||0.833|TWO_SIDED|95.0|0.48|1.81||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.81|0.48|0.833
73802136|NCT03380429|147152936|OTHER||Odds Ratio (OR)|1.35||||0.383|TWO_SIDED|95.0|0.69|2.67||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.67|0.69|0.383
73802137|NCT03380429|147152936|OTHER||Odds Ratio (OR)|0.85||||0.628|TWO_SIDED|95.0|0.44|1.63||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.63|0.44|0.628
73802138|NCT03380429|147152936|OTHER||Odds Ratio (OR)|0.94||||0.844|TWO_SIDED|95.0|0.49|1.8||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.80|0.49|0.844
73802139|NCT04760626|147152948|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec with doseguide minus once daily basal insulin analogue) was strictly below 0.3 percent point.|Treatment difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.09|||ANCOVA|||The response and change from baseline in response after 52 weeks were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors, and baseline HbA1c as a covariate.||-0.09|-0.66|<0.0001
73802140|NCT03762265|147152957|SUPERIORITY||Difference in percentage|5.73|STANDARD_ERROR_OF_MEAN|7.535||0.4469|TWO_SIDED|95.0|-9.037|20.5|||Cochran-Mantel-Haenszel|||P-value and 95% confidence interval (CI) were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed \[\<=6 months prior to screening\] or relapsing \[diagnosed greater than \[\>\] 6 months prior to screening\]).||20.500|-9.037|0.4469
73802141|NCT03762265|147152958|SUPERIORITY||Difference in percentage|8.13|STANDARD_ERROR_OF_MEAN|7.085||0.251|TWO_SIDED|95.0|-5.752|22.019|||Cochran-Mantel-Haenszel|||P-value and 95% CI were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed \[\<=6 months prior to screening\] or relapsing \[diagnosed \>6 months prior to screening\]).||22.019|-5.752|0.2510
73802142|NCT01805089|147153000|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73802143|NCT00806403|147153003|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Fisher Exact|||Null hypothesis:there is no difference in ST resolution at 120 minutes after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 50% reduction of failure to achive at least a 50% ST resolution (40% failure in thrombolysis group and 20% failure in Primary PCI group). With a power of 80% and a significance level of 0.05 (2-sided test), a total of 166 patients would be required.||||0.56
73802144|NCT00806403|147153004|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
73802145|NCT00806403|147153005|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||Null hypothesis:there is no difference in number of patients with TIMI 3 flow at 5-7 days after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 65% reduction of failure to achive TIMI 3 flow (30% failure in thrombolysis group and 10% failure in Primary PCI group). With a power of 90% and a significance level of 0.05 (2-sided test), a total of 180 patients would be required.||||0.04
73802146|NCT00806403|147153006|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||||||0.50
73802147|NCT00806403|147153007|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Fisher Exact|||||||0.21
73802148|NCT01383174|147153012|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||0.015
73894806|NCT02428478|147322328|OTHER||Median Change|-0.6||||0.037|TWO_SIDED||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit||||0.037
73894807|NCT02428478|147322328|OTHER||||||>|0.5|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit||||>0.5
73802149|NCT01383174|147153013|SUPERIORITY_OR_OTHER|||||||0.465|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.465
73802150|NCT01383174|147153014|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.025
73802151|NCT01383174|147153015|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.004
73802152|NCT01383174|147153016|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.013
73802153|NCT01383174|147153017|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.267
73802154|NCT01383174|147153018|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.030
73802155|NCT01383174|147153019|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.045
73802156|NCT01383174|147153020|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.005
73802157|NCT01383174|147153021|SUPERIORITY_OR_OTHER|||||||0.226|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.226
73802158|NCT01787292|147153022|SUPERIORITY|||||||0.001||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|Least square means were adjusted for carryover from the crossover design and between subjects effects were analyzed using Kenward-Roger df estimation||||||.001
73802159|NCT01787292|147153023|SUPERIORITY|||||||0.8|||||||ANCOVA|||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.||||.8
73802160|NCT01787292|147153024|SUPERIORITY|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|||||||.05
73802161|NCT01787292|147153025|SUPERIORITY|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|A Kenward-Rogers adjustment for degrees of freedom was made to account for carryover effects.||||||.05
73802162|NCT01787292|147153026|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
73802163|NCT01787292|147153027|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
73802164|NCT01787292|147153028|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
73802165|NCT01787292|147153029|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||.5
73802166|NCT01787292|147153030|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|A Kenward-Rogers adjustment for df was made to account for carryover effects.||||||.6
73802167|NCT01787292|147153031|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||.4
73802168|NCT01787292|147153032|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
73802169|NCT01787292|147153033|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||.25
73802170|NCT01787292|147153034|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
73802171|NCT00226499|147153085|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.943|||<|0.0001|TWO_SIDED|97.5|92.446|96.615|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||96.615|92.446|<0.0001
73802172|NCT00226499|147153085|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|65.428||||0.1265|TWO_SIDED|97.5|57.182|72.086|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||72.086|57.182|0.1265
73802173|NCT00226499|147153086|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.498||||0.0001|TWO_SIDED|95.0|97.522|99.898|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||99.898|97.522|0.0001
73802174|NCT00226499|147153086|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|90.741||||0.1265|TWO_SIDED|95.0|85.866|93.934|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||93.934|85.866|0.1265
73894808|NCT02663934|147322329|SUPERIORITY||Mean Difference (Net)|0.15||||0.31|TWO_SIDED|95.0|0.05|0.25|||ANOVA|||||.25|.05|0.31
73894809|NCT02663934|147322330|SUPERIORITY||Mean Difference (Net)|1.42||||0.24|TWO_SIDED||||||ANOVA|||Change in Global CBF in EXS vs. SIS||||.24
73802175|NCT00226499|147153087|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|92.487|||<|0.0001|TWO_SIDED|95.0|89.927|94.396|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||94.396|89.927|<0.0001
73802176|NCT00226499|147153087|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|64.585||||0.1265|TWO_SIDED|95.0|57.503|70.486|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||70.486|57.503|0.1265
73802177|NCT00226499|147153107|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|95.855|||<|0.0001|TWO_SIDED|95.0|94.075|97.101|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||97.101|94.075|<0.0001
73802178|NCT00226499|147153107|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|69.812||||0.1265|TWO_SIDED|95.0|62.848|75.47|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||75.470|62.848|0.1265
73802179|NCT00226499|147153108|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.072|||<|0.0001|TWO_SIDED|95.0|97.907|99.589|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||99.589|97.907|<0.0001
73802180|NCT00226499|147153108|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|89.532||||0.1265|TWO_SIDED|95.0|86.126|92.102|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||92.102|86.126|0.1265
73802181|NCT00226499|147153109|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.816|||<|0.0001|TWO_SIDED|95.0|92.838|96.248|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||96.248|92.838|<0.0001
73802182|NCT00226499|147153109|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|68.932||||0.1265|TWO_SIDED|95.0|61.893|74.671|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||74.671|61.893|0.1265
73802183|NCT00946920|147153123|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between treatments (degarelix versus goserelin acetate) was chosen to be -5 percentage points.|Kaplan-Meier estimate|79.6|||||TWO_SIDED|95.0|75.6|83.7||||||The cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364 was estimated by the Kaplan-Meier method. Only testosterone measurements taken at scheduled trial visits from Day 3 to Day 364 were included in the analysis. The hypothesis to test was the following: a non-inferiority assessment determined whether degarelix was non-inferior to goserelin with respect to the cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364.||83.7|75.6|
73802184|NCT01597973|147153128|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
73802185|NCT01597973|147153129|SUPERIORITY|||||||0.583|||||||Chi-squared|||||||0.5830
73802186|NCT01597973|147153130|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
73802187|NCT01597973|147153131|SUPERIORITY|||||||0.255|||||||Chi-squared|||||||0.255
73802188|NCT01597973|147153132|SUPERIORITY|||||||0.59|||||||Chi-squared|||nephrotoxicity analysis||||0.59
73802189|NCT01597973|147153132|SUPERIORITY|||||||0.22|||||||Fisher Exact|||Hypersensitivity analysis||||0.22
73802190|NCT01597973|147153132|SUPERIORITY|||||||0.94|||||||Chi-squared|||Hepatoxicity analysis||||0.94
73802191|NCT01597973|147153132|SUPERIORITY|||||||1|||||||Fisher Exact|||Seizures analysis||||1.00
73802192|NCT01597973|147153132|SUPERIORITY|||||||0.2|||||||Fisher Exact|||Neurotoxicity analysis||||0.20
73802193|NCT00803790|147153160|SUPERIORITY_OR_OTHER_LEGACY||least square mean ratio|1.01|||||TWO_SIDED|90.0|0.92|1.11||||||||1.11|0.92|
73802194|NCT00803790|147153161|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0||||||Least squares mean ratio for AUC 0-80 hr for vitamin D following administration of combination tablet and vitamin D alone. No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis.||1.00|0.89|
73802195|NCT00803790|147153162|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Ratio|0.94|||||TWO_SIDED|90.0|0.88|1.0||||||"Least squares mean ratio for Cmax for vitamin D following administration of combination tablet and vitamin D alone.~No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis."||1.00|0.88|
73802196|NCT05161481|147153163|OTHER|"The adjusted mean values for percentage change at Week 24 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|-8.4|STANDARD_ERROR_OF_MEAN|8.9|||TWO_SIDED|95.0|-26.25|9.45||||||Model includes baseline HVPG as linear covariate and treatment and use of NSBBs or carvedilol as fixed effects, treatment by visit interaction and baseline HVPG by visit interaction. The following covariance structure has been used to fit the mixed model: Unstructured.||9.45|-26.25|
73894810|NCT02663934|147322330|OTHER||Slope|0.41||||0.02|ONE_SIDED|95.0|||||Regression, Linear|||Change in Strength \& Change in Frontal Brain Volume in EXS||||.02
73894811|NCT02663934|147322330|OTHER||Slope|0.4||||0.02|ONE_SIDED|95.0|||||Regression, Linear|||Changes in Brain Volumes associated with changes Memory Performance in EXS||||0.02
73894812|NCT02663934|147322331|OTHER||Slope|0.47||||0.005|ONE_SIDED|95.0|||||Regression, Linear|||Increases in Time Spent in MVPA and Increased Learning Performance in EXS||||.005
73894813|NCT02692391|147322332|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
73802197|NCT05161481|147153163|OTHER|"The adjusted mean values for percentage change at Week 24 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|-14.18|STANDARD_ERROR_OF_MEAN|9.93|||TWO_SIDED|95.0|-34.09|5.72||||||Model includes baseline HVPG as linear covariate and treatment and use of NSBBs or carvedilol as fixed effects, treatment by visit interaction and baseline HVPG by visit interaction. The following covariance structure has been used to fit the mixed model: Unstructured.||5.72|-34.09|
73802198|NCT05161481|147153164|OTHER|"The adjusted mean values for percentage change at Week 8 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|3.51|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|95.0|-8.94|15.96||||||The analysis of covariance (ANCOVA) model includes baseline hepatic venous pressure gradient (HVPG) as a linear covariate, with treatment and use of non-selective beta-blockers (NSBBs) or carvedilol as fixed effects. All intercurrent events (ICEs) will be handled using the treatment policy for the primary objective as a sensitivity analysis. That is, all data collected after the intercurrent events will be included in the analysis.||15.96|-8.94|
73802199|NCT05161481|147153164|OTHER|"The adjusted mean values for percentage change at Week 8 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|2.69|STANDARD_ERROR_OF_MEAN|6.82|||TWO_SIDED|95.0|-10.94|16.33||||||ANCOVA) model includes baseline hepatic venous pressure gradient (HVPG) as a linear covariate, with treatment and use of non-selective beta-blockers (NSBBs) or carvedilol as fixed effects. All intercurrent events (ICEs) will be handled using the treatment policy for the primary objective as a sensitivity analysis. That is, all data collected after the intercurrent events will be included in the analysis.||16.33|-10.94|
73802200|NCT00471081|147153191|SUPERIORITY||Percentage of subjects with hSBA titers|88.4|||||TWO_SIDED|95.0|81.9|93.2|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup A.||93.2|81.9|
73802201|NCT00471081|147153191|SUPERIORITY||Percentage of subjects with hSBA titers|100.0|||||TWO_SIDED|95.0|97.3|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 90%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup C.||100|97.3|
73802202|NCT00471081|147153191|SUPERIORITY||Percentage of subjects with hSBA titers|99.3|||||TWO_SIDED|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup W-135.||100|96.2|
73802203|NCT00471081|147153191|SUPERIORITY||Percentage of subjects with hSBA titers|99.3|||||TWO_SIDED|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup Y.||100|96.2|
73894814|NCT02692391|147322333|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
73894815|NCT02692391|147322334|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
73894816|NCT02692391|147322335|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73894817|NCT02969655|147322367|NON_INFERIORITY|Non-inferiority was established if the lower limit of the 95% CI was greater than -1.0 g/dL. Even if the 95% CI for the difference was completely negative (i.e. lied fully within the range -1.0 to \<0 g/dL) non-inferiority was concluded on condition that the mean Hgb estimated in the daprodustat group was within the target range.|Mean Difference (Final Values)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.11|0.23||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction, Baseline-by-visit interaction.|||0.23|-0.11|<.0001
73894818|NCT02969655|147322368|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7442|TWO_SIDED|95.0|0.34|1.71||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment and Baseline Hgb.|||1.71|0.34|0.7442
73894819|NCT01510769|147322385|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1||||0.1298|TWO_SIDED|95.0|-0.03|0.23|||Cochran-Mantel-Haenszel|||||0.23|-0.03|0.1298
73894820|NCT01510769|147322385|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.29|||<|0.0001|TWO_SIDED|95.0|0.17|0.42|||Cochran-Mantel-Haenszel|||||0.42|0.17|<0.0001
73894821|NCT01510769|147322386|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.04||||0.4453|TWO_SIDED|95.0|-0.07|0.16|||Cochran-Mantel-Haenszel|||||0.16|-0.07|0.4453
73894822|NCT01510769|147322386|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09||||0.1149|TWO_SIDED|95.0|-0.02|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.02|0.1149
73894823|NCT01510769|147322387|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.03||||0.645|TWO_SIDED|95.0|-0.1|0.17|||Cochran-Mantel-Haenszel|||||0.17|-0.10|0.6450
73894824|NCT01510769|147322387|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.06||||0.4118|TWO_SIDED|95.0|-0.08|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.08|0.4118
73894825|NCT01510769|147322388|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.3034|TWO_SIDED|95.0|-0.24|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.24|0.3034
73802204|NCT02946463|147153334|NON_INFERIORITY|LDH-N was analyzed using a generalized estimating equation (GEE) approach. The model included the following terms: treatment group, history of transfusion (as a categorical variable based on the stratification factor levels), and baseline LDH level (as a continuous variable). Noninferiority margin was based on the lower bound of the 95% confidence interval (CI) for the odds ratio (OR) of ravulizumab versus eculizumab for LDH normalization being greater than an OR of 0.39.|Odds Ratio (OR)|1.187|||||TWO_SIDED|95.0|0.796|1.769||||||A minimum of 142 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab.||1.769|0.796|
73802205|NCT02946463|147153335|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|6.8|||||TWO_SIDED|95.0|-4.66|18.14|||||Treatment difference was estimated for ravulizumab - eculizumab.|A minimum of 193 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab. The difference of percentages were calculated using stratified Newcombe CI method. Stratification factors were: observed stratification groups of packed red blood cells (pRBC)/whole blood units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||18.14|-4.66|
73802206|NCT02946463|147153336|NON_INFERIORITY|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-6.7|||||TWO_SIDED|95.0|-14.21|0.18|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||0.18|-14.21|
73802207|NCT02946463|147153337|NON_INFERIORITY|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-0.83|||||TWO_SIDED|95.0|-5.21|3.56|||||Treatment difference was estimated for ravulizumab - eculizumab.|||3.56|-5.21|
73802208|NCT02946463|147153338|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -5%.|Treatment difference|0.67|||||TWO_SIDED|95.0|-1.21|2.55|||||Treatment difference was estimated for ravulizumab - eculizumab.|||2.55|-1.21|
73802209|NCT02946463|147153339|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|2.9|||||TWO_SIDED|95.0|-8.8|14.64|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||14.64|-8.80|
73802210|NCT05691712|147153346|SUPERIORITY||LS Mean Difference|-16.1|||<|0.001|TWO_SIDED|95.0|-19.9|-12.36|||Mixed Models Analysis|||||-12.36|-19.9|<0.001
73802211|NCT05691712|147153346|SUPERIORITY||LS Mean Difference|-15.9|||<|0.001|TWO_SIDED|95.0|-19.7|-12.1|||Mixed Models Analysis|||||-12.10|-19.7|<0.001
73802212|NCT05691712|147153347|SUPERIORITY||LS Mean Difference|-13.06|||<|0.001|TWO_SIDED|95.0|-16.8|-9.34|||Mixed Models Analysis|||||-9.34|-16.8|<0.001
73802213|NCT05691712|147153348|SUPERIORITY||LS Mean Difference|-4.4|||<|0.001|TWO_SIDED|95.0|-5.8|-2.9|||Mixed Models Analysis|||||-2.9|-5.8|<0.001
73802214|NCT05691712|147153348|SUPERIORITY||LS Mean Difference|-6.5|||<|0.001|TWO_SIDED|95.0|-8.0|-5.0|||Mixed Models Analysis|||||-5.0|-8.0|<0.001
73802215|NCT05691712|147153348|SUPERIORITY||LS Mean Difference|-6.0|||<|0.001|TWO_SIDED|95.0|-7.5|-4.5|||Mixed Models Analysis|||||-4.5|-7.5|<0.001
73802216|NCT05691712|147153350|SUPERIORITY||LS Mean Difference|-21.9|||<|0.001|TWO_SIDED|95.0|-32.4|-11.3|||Mixed Models Analysis|||||-11.3|-32.4|<0.001
73802217|NCT05691712|147153350|SUPERIORITY||LS Mean Difference|-28.9|||<|0.001|TWO_SIDED|95.0|-39.6|-18.1|||Mixed Models Analysis|||||-18.1|-39.6|<0.001
73802218|NCT05691712|147153350|SUPERIORITY||LS Mean Difference|-27.3|||<|0.001|TWO_SIDED|95.0|-38.2|-16.5|||Mixed Models Analysis|||||-16.5|-38.2|<0.001
73802219|NCT00204490|147153362|OTHER|||||||0.071|||||||t-test, 2 sided|||(FGBT% at 1 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.||||0.071
73802220|NCT00204490|147153362|OTHER|||||||0.08|||||||t-test, 2 sided|||(FGBT% at 2 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.||||0.080
73802221|NCT00204490|147153362|OTHER||Slope|-0.107|STANDARD_ERROR_OF_MEAN|0.045||0.019|TWO_SIDED||||||Regression, Linear|Mixed model|slope for interaction of treatment and time, placebo was the reference group; square root transformed outcome.|Intention to treat||||0.019
73802222|NCT02166333|147153365|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.54|TWO_SIDED|95.0|0.76|1.15||The P value is nominal and two-sided.|Log Rank||The Experience on Best Dose versus 200 IU/day hazard ratio and its 95% confidence interval were derived from a Cox regression model with dose group as the single model variable.|The Experience on Best Dose group includes all participants assigned or switched to best dose (1000 IU/day) and excludes 41 participants randomized to 2000 or 4000 IU/day who were never issued a bottle of best dose. For those randomized to 2000 or 4000 IU/day, at-risk time and events are measured from the date of their switch to best dose. 150 Experience on Best Dose participants (median follow-up, 10.2 mos) and 125 200 IU/day participants (median follow-up, 20.3 mos) were censored.||1.15|0.76|0.54
73802223|NCT02166333|147153365|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.86|1.25|||||The comparison of the Pooled Higher Doses group versus the 200 IU/d group is a sensitivity analysis.|||1.25|0.86|
73802224|NCT02166333|147153366|SUPERIORITY|The overall P tests for difference between groups in differential change from baseline over time and is from a 3 degree of freedom test of the combined 3 treatment-by-time interaction terms from the longitudinal mixed effects model.||||||0.15||||||The P value is nominal and not adjusted for multiple comparisons.|Regression, Linear|3 degree of freedom interaction test||The two groups were assessed for differential change over time in change from baseline using a longitudinal mixed effects regression model with gait speed as the outcome and fixed effects including a single treatment term, 3 time point terms and 3 treatment-by-time interaction terms and a random intercept for participant.||||0.15
73894826|NCT01510769|147322388|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.19||||0.021|TWO_SIDED|95.0|-0.34|-0.04|||Cochran-Mantel-Haenszel|||||-0.04|-0.34|0.0210
73894827|NCT01980485|147322409|NON_INFERIORITY_OR_EQUIVALENCE|This study had 87% power to detect a 40% increase in 28-dayabstinence rates (i.e., from 50% to 70%) based on a two-tailed chi-squared test and alpha = 0.05. We selected this effect size as being at the lower end of the effect size continuum that would be clinically meaningful at 28 days and have the potential to still be meaningful in the longer term even with similar relapse rates in both groups over subsequent months.||||||0.65|||||||Chi-squared|||||||.65
73802225|NCT00359424|147153390|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.5||||0.7031|TWO_SIDED|95.0|-6.1|9.1||The CMH statistic is tested at the two-sided alpha level of 0.05. For the interim analyses of the primary efficacy analysis, the alpha spending function method (Lan and DeMets, 1987) with O'Brien and Fleming (1979) stopping boundaries were adopted.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms).||9.1|-6.1|.7031
73802226|NCT00359424|147153391|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.0||||0.5241|TWO_SIDED|99.0|-10.3|6.2||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms).||6.2|-10.3|.5241
73802227|NCT00359424|147153392|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.4||||0.8275|TWO_SIDED|99.0|-4.6|5.5||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms).||5.5|-4.6|.8275
73802228|NCT03830333|147153415|NON_INFERIORITY|Ceftolozane/tazobactam + metronidazole is concluded to be non-inferior to meropenem + placebo if the lower bound of the 95% CI for the treatment difference in percent response is above -12.5 percentage points.|Difference in percentages|2.1|||||TWO_SIDED|95.0|-4.7|8.8||||||Difference in percentage was based on Miettinen and Nurminen method with the Cochran-Mantel-Haenszel (CMH) weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||8.8|-4.7|
73802229|NCT03830333|147153416|OTHER||Difference in percentages|-4.4|||||TWO_SIDED|95.0|-12.6|3.7||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||3.7|-12.6|
73802230|NCT03830333|147153417|OTHER||Difference in percentages|1.4|||||TWO_SIDED|95.0|-3.8|6.7||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||6.7|-3.8|
73802231|NCT03830333|147153418|OTHER||Difference in percentages|-1.5|||||TWO_SIDED|95.0|-8.0|4.8||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||4.8|-8.0|
73802232|NCT03830333|147153419|OTHER||Difference in percentages|1.2|||||TWO_SIDED|95.0|-9.2|10.4||||||Difference in percentage based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||10.4|-9.2|
73802233|NCT03830333|147153420|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-1.0|||||TWO_SIDED|95.0|-11.9|8.7||||||Gram-negative aerobes comparison: Based on unstratified Miettinen and Nurminen method.||8.7|-11.9|
73894828|NCT03060551|147322415|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.256||||||p value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.256
73802234|NCT03830333|147153420|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-1.2|||||TWO_SIDED|95.0|-12.5|8.5||||||All enterobacteriaceae comparison: Based on unstratified Miettinen and Nurminen method.||8.5|-12.5|
73802235|NCT03830333|147153420|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-8.2|||||TWO_SIDED|95.0|-42.2|20.0||||||Gram-positive aerobes comparison: Based on unstratified Miettinen and Nurminen method.||20.0|-42.2|
73802236|NCT03830333|147153421|OTHER||Difference in Percentages|-0.7|||||TWO_SIDED|95.0|-12.6|11.2||||||Difference in percentage was based on Miettinen \& Nurminen method.||11.2|-12.6|
73802237|NCT03830333|147153422|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-4.4|4.4||||||Difference in percentage was based on Miettinen \& Nurminen method.||4.4|-4.4|
73802238|NCT03805412|147153429|SUPERIORITY|||||||0.694|||||||t-test, 2 sided|||||||0.694
73802239|NCT02996227|147153458|NON_INFERIORITY|The noninferiority was defined as no more than 25% greater opioid consumption and no worse than 1-point higher pain score at rest. Non-inferiority of TAP with liposomal bupivacaine to epidural could be claimed if the upper limit of the 95.2% CI for the mean difference of pain scores at rest was less than 1 point and the CI for the ratio of geometric means in opioid consumption was less than 1.25.|Mean Difference (Final Values)|0.09|||<|0.001|TWO_SIDED|95.2|-0.12|0.3|||Mixed Models Analysis|||||0.30|-0.12|<0.001
73802240|NCT02996227|147153459|NON_INFERIORITY|The noninferiority was defined as no more than 25% greater opioid consumption and no worse than 1-point higher pain score at rest. Non-inferiority of TAP with liposomal bupivacaine to epidural could be claimed if the upper limit of the 95.2% CI for the mean difference of pain scores at rest was less than 1 point and the CI for the ratio of geometric means in opioid consumption was less than 1.25.|Ratio of Geometric means|1.37||||0.754|TWO_SIDED|95.2|1.05|1.79|||Mixed Models Analysis|||||1.79|1.05|0.754
73802241|NCT02996227|147153460|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.56|TWO_SIDED|99.0|0.53|2.76|||Regression, Linear|linear regression after logarithm transformation||||2.76|0.53|0.560
73802242|NCT02996227|147153461|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.357|TWO_SIDED|99.0|-0.65|1.37|||Regression, Linear||Difference in means between two groups was assessed using mixed effects model with repeated measurements with unstructured correlation structure|||1.37|-0.65|0.357
73802243|NCT02996227|147153462|SUPERIORITY||Risk Ratio (RR)|0.64||||0.006|TWO_SIDED|99.0|0.42|0.98|||generalized linear regression|||||0.98|0.42|0.006
73802244|NCT02996227|147153463|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.695|TWO_SIDED|99.0|-4.31|5.85|||Regression, Linear||Difference in means between two groups was assessed using mixed effects model with repeated measurements with unstructured correlation structure.|||5.85|-4.31|0.695
73802245|NCT02996227|147153464|SUPERIORITY||Ratio of geometric means|0.98||||0.738|TWO_SIDED|99.0|0.86|1.12|||Regression, Linear|linear regression after logarithmic transformation||||1.12|0.86|0.738
73802246|NCT07091916|147153468|OTHER|This objective was for the purpose of gathering data pertaining to device safety over the first 2 weeks post-implant. There were no pre-specified performance criteria or hypotheses for this objective.|Proportion|92.9|||||TWO_SIDED||||||descriptive statistics|||The first primary objective is to characterize the freedom from major complications related to the EV ICD System and/or procedure at 2 weeks post-implant. The endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 2 weeks (14 days) post-implant.||||
73802247|NCT07091916|147153469|OTHER|There were no hypotheses for this objective.|Proportion|100.0|||||||||||descriptive statistics|||The primary efficacy objective was to characterize the defibrillation efficacy at implant of the EV ICD System.||||
73802248|NCT04225715|147153565|SUPERIORITY||Difference in Response Rate|7.2|||||TWO_SIDED|95.0|-2.1|16.4|||||95% CI for difference of two proportions was calculated using Cochran-Mantel-Haenszel (CMH) method.|||16.4|-2.1|
73802249|NCT04225715|147153565|SUPERIORITY||Difference in Response Rate|3.5|||||TWO_SIDED|95.0|-3.1|10.0|||||95% CI for difference of two proportions was calculated using CMH method.|||10|-3.1|
73802250|NCT04225715|147153565|SUPERIORITY||Difference in Response Rate|24.3|||||TWO_SIDED|95.0|9.0|39.5|||||95% CI for difference of two proportions was calculated using CMH method.|||39.5|9|
73894829|NCT03060551|147322416|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.682||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.682
73894830|NCT03060551|147322417|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.151||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.151
73802251|NCT04225715|147153565|SUPERIORITY||Difference in Response Rate|12.3|||||TWO_SIDED|95.0|1.3|23.3|||||95% CI for difference of two proportions was calculated using CMH method.|||23.3|1.3|
73802252|NCT04225715|147153565|SUPERIORITY||Difference in Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||95% CI for difference of two proportions was calculated using CMH method.|||0|0|
73802253|NCT04225715|147153565|SUPERIORITY||Difference in Response Rate|6.7|||||TWO_SIDED|95.0|-2.2|15.7|||||95% CI for difference of two proportions was calculated using CMH method.|||15.7|-2.2|
73802254|NCT04225715|147153566|SUPERIORITY||6.2|6.2|||||TWO_SIDED|95.0|-2.0|14.5|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 7: Week 24||14.5|-2|
73802255|NCT04225715|147153566|SUPERIORITY||Difference in Response Rate|13.4|||||TWO_SIDED|95.0|1.2|25.6|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 8: Week 36||25.6|1.2|
73802256|NCT04225715|147153566|SUPERIORITY||Difference in Response Rate|7.2|||||TWO_SIDED|95.0|-2.1|16.4|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 2: Week 48||16.4|-2.1|
73802257|NCT04225715|147153566|SUPERIORITY||Difference in Response Rate|3.5|||||TWO_SIDED|95.0|-3.1|10.0|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 3: Week 48||10|-3.1|
73802258|NCT04225715|147153566|SUPERIORITY||Difference in Response Rate|31.2|||||TWO_SIDED|95.0|14.7|47.6|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 4: Week 48||47.6|14.7|
73802259|NCT04225715|147153566|SUPERIORITY||Difference in Response Rate|18.4|||||TWO_SIDED|95.0|5.4|31.4|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 6: Week 48||31.4|5.4|
73802260|NCT04225715|147153566|SUPERIORITY||Difference in Response Rate|8.1|||||TWO_SIDED|95.0|-3.9|20.1|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 2: FUW 48||20.1|-3.9|
73802261|NCT04225715|147153566|SUPERIORITY||Difference in Response Rate|-2.7|||||TWO_SIDED|95.0|-8.1|2.7|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 3: FUW 48||2.7|-8.1|
73802262|NCT04225715|147153566|SUPERIORITY||Difference in Response Rate|14.6|||||TWO_SIDED|95.0|0.4|28.8|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 4: FUW 48||28.8|0.4|
73802263|NCT04225715|147153566|SUPERIORITY||Difference in Response Rate|9.5|||||TWO_SIDED|95.0|-2.5|21.5|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 6: FUW 48||21.5|-2.5|
73802264|NCT05251337|147153585|SUPERIORITY|||||||0.462|||||||Mixed Models Analysis|||||||0.462
73802265|NCT05251337|147153586|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||||||0.285
73802266|NCT05251337|147153588|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||0.091
73802267|NCT04537078|147153612|OTHER||Median Difference (Final Values)|1.5||||0.254|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.254
73802268|NCT04537078|147153613|OTHER||Median Difference (Final Values)|9.48||||0.219|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.219
73802269|NCT04537078|147153614|OTHER||Median Difference (Final Values)|1.0||||0.269|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.269
73802270|NCT04537078|147153615|OTHER||Median Difference (Final Values)|0.0||||0.072|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.072
73802271|NCT04537078|147153616|OTHER|||||||1|||||||Fisher Exact|||||||1
73802272|NCT04537078|147153617|OTHER|||||||0.72|||||||Chi-squared|||||||0.720
73802273|NCT04537078|147153618|OTHER||Median Difference (Final Values)|2.0||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.002
73802274|NCT04537078|147153619|OTHER||Median Difference (Final Values)|600.0||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
73802275|NCT04537078|147153620|OTHER||Median Difference (Final Values)|2.0||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
73802276|NCT04537078|147153621|OTHER||Median Difference (Final Values)|33.33||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
73802277|NCT04537078|147153622|OTHER||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73802278|NCT04537078|147153623|OTHER||Median Difference (Final Values)|0.0||||0.851|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.851
73802279|NCT04537078|147153624|OTHER||Median Difference (Final Values)|25.0||||0.304|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.304
73802280|NCT04537078|147153625|OTHER||Median Difference (Final Values)|1.0||||0.486|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.486
73802281|NCT01568892|147153629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.16|||<|0.001|TWO_SIDED|95.0|-1.52|-0.8|||ANCOVA||The estimated value represents the adjusted mean difference between the two treatment arms.|||-0.80|-1.52|<0.001
73802282|NCT01256450|147153665|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.587|TWO_SIDED|95.0|-0.646|0.366|||ANCOVA|||||0.366|-0.646|.5870
73802283|NCT03889418|147153685|SUPERIORITY||Odds Ratio, log|-0.009|STANDARD_ERROR_OF_MEAN|0.153||0.956|TWO_SIDED|95.0|-0.309|0.292|||Mixed Models Analysis|||||0.292|-0.309|0.956
73802284|NCT03889418|147153686|SUPERIORITY||Risk Ratio, log|-0.103|STANDARD_ERROR_OF_MEAN|0.05||0.039|TWO_SIDED|95.0|-0.2|-0.005|||Mixed Models Analysis|||||-.005|-0.200|0.039
73802285|NCT03889418|147153687|SUPERIORITY||Rate Ratio, log|0.049|STANDARD_ERROR_OF_MEAN|0.282||0.864|TWO_SIDED|95.0|-0.506|0.603|||Mixed Models Analysis|||||0.603|-0.506|0.864
73802286|NCT03889418|147153688|SUPERIORITY||rate ratio, log|0.018|STANDARD_ERROR_OF_MEAN|0.148||0.901|TWO_SIDED|95.0|-0.272|0.308|||Mixed Models Analysis|||||0.308|-0.272|0.901
73894831|NCT03060551|147322418|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.516||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.516
73802287|NCT03810092|147153723|OTHER||Odds Ratio, log|-0.04||||0.05|TWO_SIDED|95.0|-0.55|0.42|||Regression, Linear|||Relationship between ADL score evolution and hemoglobine rate, in the no transfusion group||0.42|-0.55|0.05
73802288|NCT03810092|147153723|OTHER||Odds Ratio, log|0.39||||0.05|TWO_SIDED|95.0|-1.0|2.2|||Regression, Logistic|||Relationship between ADL score evolution and hemoglobine rate, in the transfusion group||2.2|-1|0.05
73802289|NCT02816736|147153733|SUPERIORITY||ratio of the AUCs|0.95||||0.45|TWO_SIDED|95.0|0.84|1.08|||Regression, Linear|||AUC was normalized for time; With the log-scale, the value of 0 indicates, on average, no change in NTproBNP from baseline.||1.08|0.84|0.45
73802290|NCT02816736|147153734|SUPERIORITY||Mean Difference (Net)|-11.22||||0.15|TWO_SIDED|95.0|-26.4|3.97|||general linear model|||||3.97|-26.4|0.15
73802291|NCT02816736|147153735|SUPERIORITY||Odds Ratio (OR)|1.14||||0.51|TWO_SIDED|95.0|0.78|1.68|||ordinal logistic regression|||||1.68|0.78|0.51
73802292|NCT02816736|147153736|SUPERIORITY||Odds Ratio (OR)|1.55||||0.16|TWO_SIDED|95.0|0.84|2.87|||Regression, Logistic|||||2.87|0.84|0.16
73802293|NCT02816736|147153737|SUPERIORITY||Odds Ratio (OR)|0.99||||0.99|TWO_SIDED|95.0|0.34|2.91|||Regression, Logistic|||||2.91|0.34|0.99
73802294|NCT02816736|147153738|SUPERIORITY||Odds Ratio (OR)|2.05||||0.035|TWO_SIDED|95.0|1.05|4.0|||Regression, Logistic|||||4.00|1.05|0.035
73802295|NCT01139775|147153749|SUPERIORITY_OR_OTHER||Bayesian Posterior Probability|0.96|||||TWO_SIDED||||||||Pemetrexed + cisplatin + LY2603618 was considered superior to pemetrexed + cisplatin if the posterior probability of superiority exceeded 0.85.|The analysis for comparing progression-free survival time between the treatment arms used a Bayesian Augmented Control model with a hierarchical random-effects distribution on treatment effects. The final model incorporated historical data from a completed Phase 3 study (NCT00789373) to augment the prospective control arm data.||||
73802296|NCT01139775|147153751|SUPERIORITY_OR_OTHER|||||||0.2294|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Log Rank|||||||0.2294
73802297|NCT01139775|147153752|SUPERIORITY_OR_OTHER|||||||0.0824|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared|||||||0.0824
73802298|NCT01139775|147153753|SUPERIORITY_OR_OTHER|||||||0.4924|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Wilcoxon (Mann-Whitney)|||||||0.4924
73802299|NCT01139775|147153764|SUPERIORITY_OR_OTHER|||||||0.0946|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared|||||||0.0946
73802300|NCT01753310|147153767|SUPERIORITY_OR_OTHER||Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-12.17|-4.47|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified analysis of covariance (ANCOVA) with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).||-4.47|-12.17|<0.001
73802301|NCT01753310|147153768|SUPERIORITY_OR_OTHER||Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|1.65|=|0.001|TWO_SIDED|95.0|-8.67|-2.14|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified ANCOVA with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).||-2.14|-8.67|=0.001
73802302|NCT01753310|147153769|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an analysis of variance (ANOVA) with treatment and randomisation stratification factor as main effects.||||<0.001
73802303|NCT01753310|147153770|SUPERIORITY_OR_OTHER||||||=|0.033|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.||||=0.033
73894832|NCT03060551|147322419|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.|||||>|0.999||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||>0.999
73802304|NCT01753310|147153771|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||<0.001
73802305|NCT01753310|147153772|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.||||<0.001
73802306|NCT01753310|147153773|SUPERIORITY_OR_OTHER||||||=|0.174|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||=0.174
73802307|NCT01753310|147153774|SUPERIORITY_OR_OTHER||||||=|0.583|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||=0.583
73802308|NCT00503698|147153805|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||0.91|TWO_SIDED|95.0|0.6|1.57|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates||||1.57|0.60|0.91
73802309|NCT00503698|147153806|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.4977|TWO_SIDED|95.0|0.6|1.28|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates||||1.28|0.60|0.4977
73802310|NCT00503698|147153807|SUPERIORITY_OR_OTHER||Rate ratio|1.13||||0.4409|TWO_SIDED|95.0|0.83|1.53|||Negative binomial regression|||||1.53|0.83|0.4409
73802311|NCT01445730|147153837|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73802312|NCT01445730|147153838|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
73802313|NCT01445730|147153839|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
73802314|NCT01445730|147153840|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73802315|NCT01445730|147153841|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
73802316|NCT01445730|147153842|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73802317|NCT01445730|147153843|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
73802318|NCT05514873|147153855|NON_INFERIORITY|Non-inferiority of Week 12 MG-ADL over Baseline was shown if the upper limit of the 2-sided 95% confidence interval (CI) is less than 2.|||||<|0.001|||||||Mixed Model for Repeated Measures (MMRM)|||||||<0.001
73802319|NCT03971071|147153918|SUPERIORITY||Common odds ratio|1.37||||0.13|TWO_SIDED|95.0|0.92|2.05|||Cochran-Mantel-Haenszel||Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||2.05|0.92|0.13
73802320|NCT03971071|147153918|SUPERIORITY||Common odds ratio|2.01|||<|0.001|TWO_SIDED|95.0|1.33|3.05|||Cochran-Mantel-Haenszel||Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||3.05|1.33|<0.001
73802321|NCT03971071|147153919|SUPERIORITY||Least squares mean difference|-1.23||||0.033|TWO_SIDED|95.0|-2.35|-0.1||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.10|-2.35|0.033
73802322|NCT03971071|147153919|SUPERIORITY||Least squares mean difference|-2.74|||<|0.001|TWO_SIDED|95.0|-3.87|-1.62||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-1.62|-3.87|<0.001
73802323|NCT03971071|147153920|SUPERIORITY||Common odds ratio|1.62||||0.019|TWO_SIDED|95.0|1.08|2.43|||Cochran-Mantel-Haenszel||Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||2.43|1.08|0.019
73802324|NCT03971071|147153920|SUPERIORITY||Common odds ratio|2.63|||<|0.001|TWO_SIDED|95.0|1.75|3.96|||Cochran-Mantel-Haenszel||Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||3.96|1.75|<0.001
73802325|NCT03971071|147153921|SUPERIORITY||Least squares mean difference|-3.25||||0.007|TWO_SIDED|95.0|-5.62|-0.88||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.88|-5.62|0.007
73802326|NCT03971071|147153921|SUPERIORITY||Least squares mean difference|-2.13||||0.075|TWO_SIDED|95.0|-4.48|0.22||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||0.22|-4.48|0.075
73802327|NCT03971071|147153922|SUPERIORITY||Least squares mean difference|-2.61||||0.028|TWO_SIDED|95.0|-4.92|-0.29||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.29|-4.92|0.028
73802328|NCT03971071|147153922|SUPERIORITY||Least squares mean difference|-2.37||||0.043|TWO_SIDED|95.0|-4.67|-0.07||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.07|-4.67|0.043
73802329|NCT01697748|147153924|SUPERIORITY|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.44|1.96||Variables with at least a borderline association with a treatment arm (P≤ .10) were included in a multiple logistic regression model to verify which is independently associated with the outcome of interest||No P values were reported for the association between dressing type and infection, only relative risk and 95% confidence intervals were reported.||With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Besides the Chi Square, Fisher's Exact test, Student T-test, Mann Whitney U test, and logistic regression were utilized where appropriate|1.96|0.44|
73802330|NCT01697748|147153924|SUPERIORITY|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15% vs. 7.5%) surgical site infection at a two side alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|||||<|0.05|TWO_SIDED|95.0||||Variables with at least a borderline association (P≤.10) were then included in a multiple logistic regression model to verify which is independently associated with the outcome of interest|Mixed Models Analysis|In addition to the Chi-Square, Fisher's exact test, Student T-Test, Mann Whitney U test and logistic regression were utilized when appropriate.||||||<0.05
73802331|NCT01697748|147153925|SUPERIORITY||||||<|0.05|||||||see below|Chi square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test where appropriate|||In addition to Chi-Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann Whitney test were utilized where appropriate|||<.05
73802332|NCT01697748|147153926|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Chi Square, Fisher's Exact, Student's T test, Wilcoxon-Mann-Whitney test and logistic regression when appropriate,|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney Test, and logistic regression were utilized where appropriate|||<.05
73802333|NCT01697748|147153926|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Chi Square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where appropriate|||<.05
73802334|NCT01697748|147153928|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test, and logistic regression were utilized where appropriate|||<0.05
73802335|NCT01697748|147153929|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||||In addition to the Chi-square, Fisher's exact test, Student T-Test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where approprate|||<0.05
73802336|NCT01704495|147153938|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.56||||0.119|TWO_SIDED|90.0|0.98|2.49||2-sided p-value|Poisson regression|Correction for overdispersion made by Pearson chi-square|AZD5069 45 mg BID vs Placebo|||2.49|0.98|0.119
73802337|NCT01704495|147153938|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.53||||0.141|TWO_SIDED|90.0|0.95|2.46||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 15 mg BID vs Placebo|||2.46|0.95|0.141
73802338|NCT01704495|147153938|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29||||0.397|TWO_SIDED|90.0|0.79|2.11||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 5 mg BID vs Placebo|||2.11|0.79|0.397
73802339|NCT00997373|147153983|SUPERIORITY_OR_OTHER|||||||0.0373|TWO_SIDED||||||Fisher Exact|||||||0.0373
73802340|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.89|||||TWO_SIDED|95.0|0.68|1.16|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.16|0.68|
73802341|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.95|||||TWO_SIDED|95.0|0.73|1.23|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.23|0.73|
73802342|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||TWO_SIDED|95.0|0.81|1.38|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.38|0.81|
73802343|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.2|||||TWO_SIDED|95.0|0.9|1.6|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.6|0.9|
73802344|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.33|||||TWO_SIDED|95.0|1.0|1.77|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.77|1|
73802345|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||TWO_SIDED|95.0|0.68|1.2|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.2|0.68|
73802346|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||TWO_SIDED|95.0|0.63|0.97|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||0.97|0.63|
73802347|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||TWO_SIDED|95.0|0.86|1.13|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.86|
73802348|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.35|||||TWO_SIDED|95.0|1.09|1.67|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.67|1.09|
73802349|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||TWO_SIDED|95.0|0.61|1.02|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.02|0.61|
73802350|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.91|||||TWO_SIDED|95.0|0.7|1.18|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.18|0.7|
73802351|NCT00450437|147154002|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.16|||||TWO_SIDED|95.0|0.89|1.5|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.5|0.89|
73894833|NCT03060551|147322420|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.034||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.034
73894834|NCT03060551|147322421|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.656||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.656
73894835|NCT03060551|147322422|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.096||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.096
73894836|NCT03060551|147322423|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.019||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.019
73894837|NCT03060551|147322424|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.05||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.050
73894838|NCT03060551|147322425|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.372||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.372
73802352|NCT00450437|147154003|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|8.0|||||TWO_SIDED|95.0|3.0|14.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||14|3|
73802353|NCT00450437|147154003|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||7|-2|
73894839|NCT03060551|147322426|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.024||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.024
73894840|NCT03060551|147322427|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.188||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.188
73802354|NCT00450437|147154003|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|12.0|||||TWO_SIDED|95.0|6.0|18.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||18|6|
73894841|NCT03060551|147322428|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.372||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.372
73894842|NCT03060551|147322429|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.633||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.633
73894843|NCT03060551|147322430|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.38||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.380
73894844|NCT04219085|147322431|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.0
73894845|NCT04219085|147322432|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
73802355|NCT00450437|147154003|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|27.0|||||TWO_SIDED|95.0|20.0|33.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||33|20|
73802356|NCT00450437|147154004|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY was considered noninferior to Menactra if the upper limit of the two-sided 95% CI of the difference in the percentage of subjects experiencing at least one severe systemic reaction \[MenACWY minus Menactra\] was less than 6%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.0|2.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, safety.||2|-1|
73802357|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||3|-10|
73802358|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-12.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||0|-12|
73802359|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
73802360|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|5.0|||||TWO_SIDED|95.0|0.0|10.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||10|0|
73802361|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-1.0|10.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||10|-1|
73802362|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-6.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||5|-6|
73802363|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-13.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||0|-13|
73802364|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-3.0|11.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||11|-3|
73894846|NCT04219085|147322433|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||||||0.85
73802365|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|10.0|||||TWO_SIDED|95.0|4.0|17.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||17|4|
73802366|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-13.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||1|-13|
73802367|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-6.0|8.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||8|-6|
73802368|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|7.0|||||TWO_SIDED|95.0|0.0|14.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||14|0|
73802369|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||3|-10|
73802370|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-12.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||0|-12|
73802371|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
73802372|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.0|6.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||6|-3|
73802373|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-2.0|7.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||7|-2|
73894847|NCT00695097|147322434|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline)compared to post-treatment (follow-up) CD3 cell density||||0.25
73802374|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.0|6.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||6|-3|
73802375|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-5.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||1|-5|
73802376|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||2|-4|
73802377|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||4|-2|
73802378|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||2|-8|
73802379|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||2|-8|
73802380|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-5.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||5|-5|
73802381|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
73894848|NCT00695097|147322434|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline) compared to post-treatment (follow-up) CD3 cell density||||0.46
73894849|NCT00695097|147322434|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||pretreatment (baseline) compared to post-treatment (follow-up) biopsy CD20 cell density||||0.054
73894850|NCT00695097|147322434|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (baseline) compared to post-treatment (follow-up) CD20 cell density||||0.62
73802382|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||1|-11|
73802383|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-8.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-8|
73802384|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%)||5|-3|
73802385|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||4|-4|
73802386|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||4|-4|
73802387|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-5.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||1|-5|
73802388|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||2|-4|
73802389|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||3|-2|
73894851|NCT05141448|147322494|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of was below 0.05 logMAR|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.011|||TWO_SIDED|95.0|0.02|0.06|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as senofilcon A C3 (EMO-118) minus omafilcon A|||0.06|0.02|
73894852|NCT01043939|147322500|SUPERIORITY_OR_OTHER||Difference of least square means|-0.16||||0.25|TWO_SIDED|95.0|-0.42|0.11||24 participants required to achieve 80% power to detect mean difference of 0.3 in RH-PAT index score between juice groups, assuming standard deviation of the difference was 0.25, using a two-sided significance level of 0.05|Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|The a priori threshold for statistical significance was 0.05.|||0.11|-0.42|0.25
73894853|NCT01043939|147322501|SUPERIORITY_OR_OTHER||Difference of least square means|3.09||||0.29|TWO_SIDED|95.0|-2.73|8.91|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.||||8.91|-2.73|0.29
73894854|NCT01043939|147322502|SUPERIORITY_OR_OTHER||Ratio of means|0.92||||0.15|TWO_SIDED|95.0|0.82|1.03|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|MPO was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).|||1.03|0.82|0.15
73894855|NCT01043939|147322503|SUPERIORITY_OR_OTHER||Ratio of means|1.34||||0.37|TWO_SIDED|95.0|0.69|2.62|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|hs-CRP was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).|||2.62|0.69|0.37
73894856|NCT01221285|147322513|SUPERIORITY_OR_OTHER||Fold change|1.8||||0.02|TWO_SIDED|95.0|1.1|2.8|||Fold change||Numerator is geometric mean post-baseline IgE. Denominator is baseline IgE.|||2.8|1.1|0.02
73894857|NCT01221285|147322514|SUPERIORITY_OR_OTHER||Fold change|2.5|||<|0.0001|TWO_SIDED|95.0|1.8|3.4|||Fold change||Numerator is geometric mean post-baseline IgG. Denominator is baseline IgG.|||3.4|1.8|<0.0001
73894858|NCT01221285|147322515|SUPERIORITY_OR_OTHER||Fold change|12.9|||<|0.0001|TWO_SIDED|95.0|7.5|22.5|||Fold Change||Numerator is geometric mean post-baseline IgG4. Denominator is baseline IgG4.|||22.5|7.5|<0.0001
73894859|NCT01221285|147322516|SUPERIORITY_OR_OTHER||Change|-42.8|||<|0.0001|TWO_SIDED|95.0|-59.4|-26.2|||Change||Numerator is geometric mean post-baseline FAB. Denominator is baseline FAB.|||-26.2|-59.4|<0.0001
73894860|NCT02123251|147322517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.2139||0.0553|TWO_SIDED|95.0|-0.0092|0.8293|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, race, gender, and baseline hypertension.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||0.8293|-0.0092|0.0553
73894861|NCT02123251|147322518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2916|STANDARD_ERROR_OF_MEAN|1.9571||0.2416|TWO_SIDED|95.0|-6.1274|1.5442|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||1.5442|-6.1274|0.2416
73894862|NCT02123251|147322519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0893|STANDARD_ERROR_OF_MEAN|1.2622||0.3881|TWO_SIDED|95.0|-3.5632|1.3846|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||1.3846|-3.5632|0.3881
73894863|NCT02123251|147322520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3432|STANDARD_ERROR_OF_MEAN|7.7086||0.8617|TWO_SIDED|95.0|-16.4517|13.7653|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||13.7653|-16.4517|0.8617
73894864|NCT02123251|147322521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.787|STANDARD_ERROR_OF_MEAN|28.5519||0.5333|TWO_SIDED|95.0|-73.7478|38.1737|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||38.1737|-73.7478|0.5333
73802390|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||1|-8|
73802391|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-9.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||0|-9|
73894865|NCT02123251|147322522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9097|STANDARD_ERROR_OF_MEAN|5.2351||0.862|TWO_SIDED|95.0|-9.3509|11.1702|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||11.1702|-9.3509|0.8620
73894866|NCT02123251|147322523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7177|STANDARD_ERROR_OF_MEAN|1.0433||0.4915|TWO_SIDED|95.0|-1.3272|2.7626|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||2.7626|-1.3272|0.4915
73894867|NCT02123251|147322524|SUPERIORITY_OR_OTHER||||||>|0.05|||||||standard diffs-in-diffs model|||A standard diffs-in-diffs model was utilized to estimate the causal effect of the intervention on medical costs per patient/day. The average change in cost over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the cost per patient per day from baseline to endpoint between groups.||||>0.05
73894868|NCT02123251|147322525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6403|STANDARD_ERROR_OF_MEAN|0.3148||0.042|TWO_SIDED|95.0|0.0233|1.2572|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that for the control group. The difference in these average changes is referred to as the difference-in-differences values which was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the General Diet subscale from baseline to endpoint between groups. Generalized estimating equation modeling was used to examine changes in SDSCA between groups at different time points.||1.2572|0.0233|0.0420
73894869|NCT02123251|147322526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1188|STANDARD_ERROR_OF_MEAN|1.031||0.0399|TWO_SIDED|95.0|0.0981|4.1395|||Generalized Estimating Equation Model|The effect of age and gender is adjusted in the GEE model.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that of the control group. The difference in the average changes is referred to as the difference-in-differences values which was assessed for significance at p=0.05. Null assumed no group difference in the Physical Component Summary measure of SF-36v2 from baseline to midpoint. Generalized estimating equation (GEE) modeling was used to examine changes in health measures between groups at different time points.||4.1395|0.0981|.0399
73894870|NCT01904773|147322527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.42|STANDARD_ERROR_OF_MEAN|0.9||0.0087||||||Bonferroni-Holm adjustment, compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design||Comparison with placebo||||0.0087
73894871|NCT01904773|147322527|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.34|STANDARD_ERROR_OF_MEAN|0.85||0.1198||||||Bonferroni-Holm compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design||||||0.1198
73802392|NCT00450437|147154005|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||3|-5|
73894872|NCT03861988|147322531|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
73894873|NCT00220779|147322540|SUPERIORITY_OR_OTHER|||||||0.221||||||0.2g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.||||0.221
73802393|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||8|0|
73802394|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|5.0|||||TWO_SIDED|95.0|1.0|9.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||9|1|
73802395|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|15.0|||||TWO_SIDED|95.0|11.0|20.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs.Licensed MenaCWY vaccine, MenW.||20|11|
73802396|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|23.0|||||TWO_SIDED|95.0|19.0|28.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||28|19|
73802397|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||8|0|
73802398|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|0.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||7|0|
73802399|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|6.0|||||TWO_SIDED|95.0|4.0|9.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||9|4|
73802400|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|15.0|||||TWO_SIDED|95.0|12.0|20.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||20|12|
73802401|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||7|-1|
73802402|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.0|4.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||4|-1|
73802403|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|6.0|||||TWO_SIDED|95.0|3.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||8|3|
73802404|NCT00450437|147154006|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|12.0|||||TWO_SIDED|95.0|9.0|16.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||16|9|
73802405|NCT00450437|147154007|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain A with respect to the immune response.|hSBA GMT ratios|1.32|||||TWO_SIDED|95.0|1.12|1.56|||ANOVA|||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenA.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain A at 1 month after vaccination was to be above 0.5."||1.56|1.12|
73802406|NCT00450437|147154007|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain C with respect to the immune response.|hSBA GMT ratios|1.4|||||TWO_SIDED|95.0|1.17|1.67|||ANOVA|||"Non-inferiority of Investigation MenACWY vaccine vs. Licensed MenACWY vaccine, MenC.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain C at 1 month after vaccination was to be above 0.5."||1.67|1.17|
73802407|NCT00450437|147154007|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain W with respect to the immune response.|hSBA GMT ratios|1.76|||||TWO_SIDED|95.0|1.51|2.05|||ANOVA|||"Non-inferiority of Investigational MenACWY vaccine vs. Licensed MenACWY vaccine, MenW.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain W at 1 month after vaccination was to be above 0.5."||2.05|1.51|
73802408|NCT00450437|147154007|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y with respect to the immune response.|hSBA GMT ratios|2.49|||||TWO_SIDED|95.0|2.11|2.95|||ANOVA|||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenY.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y at 1 month after vaccination was to be above 0.5."||2.95|2.11|
73802409|NCT00450437|147154009|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-7.0|5.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||5|-7|
73802410|NCT00450437|147154009|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|9.0|||||TWO_SIDED|95.0|3.0|15.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine. MenC.||15|3|
73802411|NCT00450437|147154009|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|9.0|||||TWO_SIDED|95.0|2.0|17.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||17|2|
73802412|NCT00450437|147154009|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|16.0|||||TWO_SIDED|95.0|9.0|23.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||23|9|
73802413|NCT03296527|147154016|NON_INFERIORITY|If the lower-limit of the two-sided 95% confidence interval (CI) was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected. In that case, it would be claimed that FE 999049 was non-inferior to GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.|Risk Difference (RD)|5.4|||||TWO_SIDED|95.0|-0.2|11.0|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with ongoing pregnancy rate||11.0|-0.2|
73802414|NCT03296527|147154017|OTHER||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|0.3|12.3|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with positive beta-hCG||12.3|0.3|
73802415|NCT03296527|147154018|OTHER||Risk Difference (RD)|4.9|||||TWO_SIDED|95.0|-0.9|10.7|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with at least one gestational sac 5-6 weeks after transfer||10.7|-0.9|
73894874|NCT00220779|147322540|SUPERIORITY_OR_OTHER|||||||0.471||||||0.4 g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.||||0.471
73802416|NCT03296527|147154019|OTHER||Risk Difference (RD)|4.2|||||TWO_SIDED|95.0|-1.5|9.8|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer||9.8|-1.5|
73802417|NCT03296527|147154020|OTHER||Risk Difference (RD)|3.9|||||TWO_SIDED|95.0|-1.6|9.5|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of implanted embryos 5-6 weeks after transfer||9.5|-1.6|
73802418|NCT03296527|147154021|OTHER||Risk Difference (RD)|4.4|||||TWO_SIDED|95.0|-0.9|9.7|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with ongoing implantation rate||9.7|-0.9|
73802419|NCT03296527|147154022|SUPERIORITY|Logistic regression including AMH group as a factor.|Odds Ratio (OR)|0.79||||0.083|TWO_SIDED|95.0|0.6|1.03||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with \<4 or \>=15 oocytes retrieved||1.03|0.60|0.083
73894875|NCT02248675|147322541|SUPERIORITY_OR_OTHER|||||||0.153|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||.153
73894876|NCT02248675|147322542|SUPERIORITY_OR_OTHER|||||||0.627|||||||Regression, Linear|||||||.627
73894877|NCT02248675|147322543|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||<.001
73802420|NCT03296527|147154022|OTHER|Logistic regression including AMH group as a factor.|Odds Ratio (OR)|0.89||||0.489|TWO_SIDED|95.0|0.65|1.23||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with \<4 or \>=20 oocytes retrieved||1.23|0.65|0.489
73894878|NCT02248675|147322544|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||<.001
73894879|NCT00281658|147322555|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0062|TWO_SIDED|95.0|0.58|0.94||Stratified Log-Rank (one-sided)|Log Rank||The treatment hazard ratio based on the proportional hazard model stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|Primary OS analysis cut-off date = 18-Jun-2010||0.94|0.58|0.0062
73894880|NCT00281658|147322556|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.64|0.98|||||The treatment hazard ratio based on the proportional hazard model stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|Final OS analysis cut-0ff date = 23-Nov-2021||0.98|0.64|
73894881|NCT00281658|147322557|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.66|||||The Pike estimator of the treatment hazard ratio based on the log rank test stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|||0.66|0.44|
73802421|NCT03296527|147154023|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.6||||0.075|TWO_SIDED|95.0|0.34|1.06||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (any grade)||1.06|0.34|0.075
73802422|NCT03296527|147154023|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.75||||0.365|TWO_SIDED|95.0|0.4|1.4||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (moderate/severe)||1.40|0.40|0.365
73894882|NCT00281658|147322558|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.3|||||TWO_SIDED|95.0|1.54|3.47||||||||3.47|1.54|
73894883|NCT00281658|147322559|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.34|||||TWO_SIDED|95.0|1.54|3.58||||||||3.58|1.54|
73894884|NCT00281658|147322564|OTHER||Odds Ratio (OR)|2.78|||||TWO_SIDED|95.0|1.07|7.57||||||Participants with PIK3CA wild-type||7.57|1.07|
73802423|NCT03296527|147154023|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.33||||0.012|TWO_SIDED|95.0|0.13|0.83||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with any preventive intervention||0.83|0.13|0.012
73802424|NCT03296527|147154023|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.49||||0.004|TWO_SIDED|95.0|0.3|0.81||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (any grade) and/or preventive interventions||0.81|0.30|0.004
73802425|NCT03296527|147154023|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.56||||0.029|TWO_SIDED|95.0|0.33|0.95|||Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (moderate/severe) and/or preventive interventions||0.95|0.33|0.029
73802426|NCT03296527|147154024|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.52|13.74||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with cycle cancellation due to poor response||13.74|1.52|0.002
73802427|NCT03296527|147154024|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.24|0.62||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with transfer cancellation due to excessive ovarian response/OHSS risk||0.62|0.24|<0.001
73894885|NCT00281658|147322565|OTHER||Odds Ratio (OR)|2.42|||||TWO_SIDED|95.0|1.28|4.63||||||Participants with PTEN low||4.63|1.28|
73894886|NCT00281658|147322565|OTHER||Odds Ratio (OR)|2.21|||||TWO_SIDED|95.0|1.04|4.82||||||Participants without PTEN low||4.82|1.04|
73894887|NCT00281658|147322567|OTHER||Odds Ratio (OR)|3.15|||||TWO_SIDED|95.0|1.58|6.49||||||Participants with PTEN low||6.49|1.58|
73894888|NCT00281658|147322567|OTHER||Odds Ratio (OR)|2.49|||||TWO_SIDED|95.0|1.13|5.66||||||Participants without PTEN low||5.66|1.13|
73894889|NCT00813943|147322577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.0328|TWO_SIDED|95.0|0.484|0.972||P-value is not adjusted for multiple testing.|Log Rank|||||0.972|0.484|0.0328
73894890|NCT00813943|147322577|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.858||||0.3771|TWO_SIDED|95.0|0.612|1.204||P-value is not adjusted for multiple testing.|Log Rank|||||1.204|0.612|0.3771
73894891|NCT01235598|147322592|SUPERIORITY_OR_OTHER||Median difference within group changes|-1.5||||0.049|TWO_SIDED|95.0|-3.0|0.0||Two-sided p-value is presented, with p \< 0.05 as the threshold for statistical significance.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.0|-3.0|0.049
73802428|NCT03296527|147154024|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.62||||0.02|TWO_SIDED|95.0|0.42|0.93||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with cycle cancellation due to poor or excessive response, or transfer cancellation due to excessive response/OHSS risk||0.93|0.42|0.020
73802429|NCT03296527|147154025|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 10 mm||||<.001
73802430|NCT03296527|147154025|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 12 mm||||<.001
73802431|NCT03296527|147154025|SUPERIORITY|||||||0.568||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 15 mm||||0.568
73802432|NCT03296527|147154025|SUPERIORITY|||||||0.839||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 17 mm||||0.839
73802433|NCT03296527|147154026|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 10 mm||||<.001
73802434|NCT03296527|147154026|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 12 mm||||<.001
73802435|NCT03296527|147154026|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 15 mm||||<.001
73802436|NCT03296527|147154026|SUPERIORITY|||||||0.011|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 17 mm||||0.011
73802437|NCT03296527|147154027|SUPERIORITY|||||||0.14|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Largest follicle (mm)||||0.140
73802438|NCT03296527|147154027|SUPERIORITY|||||||0.155|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average follicle size (mm)||||0.155
73802439|NCT03296527|147154027|SUPERIORITY|||||||0.159|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Treatment comparison: Average size of 3 largest follicles (mm)||||0.159
73802440|NCT03296527|147154028|SUPERIORITY|||||||0.848|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Largest follicle (mm)||||0.848
73802441|NCT03296527|147154028|SUPERIORITY|||||||0.629|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average follicle size (mm)||||0.629
73802442|NCT03296527|147154028|SUPERIORITY|||||||0.768|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average size of 3 largest follicles (mm)||||0.768
73802443|NCT03296527|147154029|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Mean number of oocytes retrieved||||<.001
73802444|NCT03296527|147154031|SUPERIORITY|||||||0.197|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Percentage of MII oocytes / oocytes retrieved||||0.197
73802445|NCT03296527|147154032|SUPERIORITY|||||||0.79|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Fertilization rate relative to oocytes retrieved||||0.790
73802446|NCT03296527|147154033|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of embryos on day 3||||<.001
73802447|NCT03296527|147154033|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of good-quality embryos on Day 3||||<.001
73802448|NCT03296527|147154034|SUPERIORITY||Mean ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.74|0.88||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of LH on stimulation Day 6||0.88|0.74|<0.001
73802449|NCT03296527|147154035|SUPERIORITY||Mean ratio|0.9||||0.018|TWO_SIDED|95.0|0.82|0.98||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.||Circulating concentrations of LH at end-of-stimulation||0.98|0.82|0.018
73802450|NCT03296527|147154036|SUPERIORITY||Mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.7|0.84||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Estradiol on stimulation Day 6||0.84|0.70|<0.001
73802451|NCT03296527|147154037|SUPERIORITY||Mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.81||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Estradiol at end-of-stimulation||0.81|0.68|<0.001
73802452|NCT03296527|147154038|SUPERIORITY||Mean Ratio|0.89||||0.003|TWO_SIDED|95.0|0.82|0.96||The p-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Progesterone on stimulation Day 6||0.96|0.82|0.003
73802453|NCT03296527|147154039|SUPERIORITY||Mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.79||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Progesterone at end-of-stimulation||0.79|0.68|<0.001
73802454|NCT03296527|147154040|SUPERIORITY||Mean ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.7|0.83||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.||Circulating concentrations of Inhibin A on stimulation Day 6||0.83|0.70|<0.001
73802455|NCT03296527|147154041|SUPERIORITY||Mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.83||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin A at end-of-stimulation||0.83|0.71|<0.001
73802456|NCT03296527|147154042|SUPERIORITY||Mean ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.77|0.89||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin B on stimulation Day 6||0.89|0.77|<0.001
73894892|NCT01235598|147322593|SUPERIORITY_OR_OTHER||Median Difference within group changes|-1.0||||0.206|TWO_SIDED|95.0|-3.0|1.0||Two-sided p-value is presented, with p \< 0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \< 0.05). Hypothesis testing was stopped if and when a non-significant result was obtained. Testing was stopped in the next step.||1.0|-3.0|0.206
73894893|NCT01235598|147322597|SUPERIORITY_OR_OTHER||Median difference within group changes|-0.0035||||0.164|TWO_SIDED|95.0|-0.012|0.0025||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.0025|-0.0120|0.164
73894894|NCT01235598|147322598|SUPERIORITY_OR_OTHER||Median difference within group changes|-0.069||||0.865|TWO_SIDED|95.0|-0.201|0.138||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.1380|-0.2010|0.865
73894895|NCT01235598|147322599|SUPERIORITY_OR_OTHER||Median difference within group changes|-421.5||||0.015|TWO_SIDED|95.0|-1542.5|-47.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||-47.0|-1542.5|0.015
73894896|NCT01235598|147322611|SUPERIORITY_OR_OTHER|||||||0.394|||||||Spearman rank correlation|||||||0.394
73894897|NCT01235598|147322612|SUPERIORITY_OR_OTHER|||||||0.625|TWO_SIDED||||||Spearman rank correlation|||||||0.625
73894898|NCT01235598|147322613|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||Spearman rank correlation|||||||0.128
73894899|NCT01235598|147322614|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED||||||Spearman rank correlation|||||||0.732
73894900|NCT01235598|147322615|SUPERIORITY_OR_OTHER|||||||0.411|TWO_SIDED||||||Spearman rank correlation|||||||0.411
73894901|NCT01235598|147322616|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED||||||Spearman rank correlation|||||||0.208
73894902|NCT01235598|147322617|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.254|TWO_SIDED|95.0|-1.0|0.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|||0.0|-1.0|0.254
73894903|NCT01235598|147322618|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.472|TWO_SIDED|95.0|-2.0|1.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|||1.0|-2.0|0.472
73802457|NCT03296527|147154043|SUPERIORITY||Mean ratio|0.87||||0.001|TWO_SIDED|95.0|0.8|0.95||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin B at end-of-stimulation||0.95|0.80|0.001
73894904|NCT00265148|147322626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1334||||0.1695|TWO_SIDED|95.0|-0.0583|0.3251|||Mixed model for repeated measures|||For Grey matter||0.3251|-0.0583|0.1695
73894905|NCT00265148|147322626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.175||||0.1057|TWO_SIDED|95.0|-0.038|0.388|||Mixed model for repeated measures|||For posterior cingulate Gyrus||0.3880|-0.0380|0.1057
73894906|NCT00265148|147322626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1426||||0.1833|TWO_SIDED|95.0|-0.0691|0.3543|||Mixed model for repeated measures|||For Frontal lobe||0.3543|-0.0691|0.1833
73894907|NCT00265148|147322626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1366||||0.1644|TWO_SIDED|95.0|-0.0574|0.3307|||Mixed model for repeated measures|||For parietal lobe||0.3307|-0.0574|0.1644
73894908|NCT00265148|147322626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1259||||0.1509|TWO_SIDED|95.0|-0.0471|0.2989|||Mixed model for repeated measures|||For Posterior temporal lobe||0.2989|-0.0471|0.1509
73894909|NCT00265148|147322626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1339||||0.2041|TWO_SIDED|95.0|-0.0747|0.3424|||Mixed model for repeated measures|||For cerebellum||0.3424|-0.0747|0.2041
73894910|NCT00265148|147322626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1094||||0.1445|TWO_SIDED|95.0|-0.0385|0.2572|||Mixed model for repeated measures|||For medial temporal lobe||0.2572|-0.0385|0.1445
73894911|NCT00265148|147322627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1211||||0.2251|TWO_SIDED|95.0|-0.0763|0.3185|||Mixed model for repeated measures|||At Month 1||0.3185|-0.0763|0.2251
73894912|NCT00265148|147322627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0893||||0.2497|TWO_SIDED|95.0|-0.0643|0.243|||Mixed model for repeated measures|||For Month 6||0.2430|-0.0643|0.2497
73894913|NCT00265148|147322628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.11||||0.7618|TWO_SIDED|95.0|-0.59|0.8|||Repeated measure mixed model|||For BSR test , Month 1||0.80|-0.59|0.7618
73894914|NCT00265148|147322628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.06||||0.835|TWO_SIDED|95.0|-0.53|0.66|||Repeated measure mixed model|||For BSR test, Month 6||0.66|-0.53|0.8350
73894915|NCT00265148|147322628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.14||||0.6735|TWO_SIDED|95.0|-0.78|0.51|||Repeated measure mixed model|||For BSR test, Month 12||0.51|-0.78|0.6735
73894916|NCT00265148|147322629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07||||0.7045|TWO_SIDED|95.0|-0.44|0.3|||Repetaed measure mixed model|||For Month 1||0.30|-0.44|0.7045
73894917|NCT00265148|147322629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.04||||0.8181|TWO_SIDED|95.0|-0.4|0.32|||Repeated measure mixed model|||For Month 6||0.32|-0.40|0.8181
73894918|NCT00265148|147322629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.09||||0.7688|TWO_SIDED|95.0|-0.71|0.53|||Repeated measure mixed model|||AT Month 12||0.53|-0.71|0.7688
73894919|NCT00265148|147322629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07||||0.681|TWO_SIDED|95.0|-0.4|0.26|||Repeated measure mixed model|||Overall||0.26|-0.40|0.6810
73894920|NCT00265148|147322633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.8593|TWO_SIDED|95.0|-2.38|1.99|||Repeated measure mixed model|||At Month 1||1.99|-2.38|0.8593
73894921|NCT00265148|147322633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.44||||0.3201|TWO_SIDED|95.0|-1.43|4.32|||Repeated measure mixed model|||At Month 6||4.32|-1.43|0.3201
73894922|NCT00265148|147322633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.18||||0.2627|TWO_SIDED|95.0|-1.68|6.04|||Repeated measure mixed model|||At Month 12||6.04|-1.68|0.2627
73894923|NCT00265148|147322633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.14||||0.3633|TWO_SIDED|95.0|-1.35|3.64|||Repeated measure mixed model|||For overall period||3.64|-1.35|0.3633
73894924|NCT00265148|147322634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.11||||0.5647|TWO_SIDED|95.0|-0.48|0.26|||Repetaed measure mixed model|||For overall period||0.26|-0.48|0.5647
73894925|NCT00265148|147322634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9935|TWO_SIDED|95.0|-0.46|0.46|||Repeated measure mixed model|||For Month 1||0.46|-0.46|0.9935
73894926|NCT00265148|147322634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.22||||0.3794|TWO_SIDED|95.0|-0.72|0.28|||Repeated measure mixed model|||At Month 6||0.28|-0.72|0.3794
73894927|NCT00265148|147322634|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.7357|TWO_SIDED|95.0|-0.7|0.49|||Repeated measure mixed model|||At Month 12||0.49|-0.70|0.7357
73894928|NCT00265148|147322637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4971.6||||0.6299|TWO_SIDED|95.0|-255515.6|15572.4|||Repeated measure mixed model|Arithmetic means have been presented; however, statistical analysis is based upon the least square (LS) means||At Month 6||15572.4|-255515.6|0.6299
73894929|NCT00265148|147322637|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12223.0||||0.2184|TWO_SIDED|95.0|-7450.6|31896.5|||Repeated measure mixed model|||At Month 12||31896.5|-7450.6|0.2184
73802458|NCT03296527|147154044|SUPERIORITY||Mean ratio|1.08|||<|0.001|TWO_SIDED|95.0|1.04|1.12||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH on stimulation Day 6||1.12|1.04|<0.001
73894930|NCT00265148|147322638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.0129|TWO_SIDED|95.0|-1.0|-0.1|||Repeated measure mixed model|||For Month 6||-0.1|-1.0|0.0129
73894931|NCT00265148|147322638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.5607|TWO_SIDED|95.0|-1.0|0.6|||Repeated measure mixed model|||For Month 12||0.6|-1.0|0.5607
73894932|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1154||||0.28|TWO_SIDED|95.0|-0.0967|0.3275|||Repeated measure mixed model|||For Grey matter, APOE Epsilon-4 status positive||0.3275|-0.0967|0.2800
73894933|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1337||||0.4159||95.0|-0.1931|0.4605|||Repeated measure mixed model|||For Grey matter, APOE Epsilon-4 status negative||0.4605|-0.1931|0.4159
73894934|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1491||||0.2158|TWO_SIDED|95.0|-0.0897|0.3878|||Repeated measure mixed model|||For posterior cingulate gyrus, APOE Epsilon-4 status positive||0.3878|-0.0897|0.2158
73894935|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2346||||0.2087|TWO_SIDED|95.0|-0.135|0.6042|||Repeated measure mixed model|||For posterior cingulate gyrus, APOE Epsilon-4 status negative||0.6042|-0.1350|0.2087
73894936|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1233||||0.3064|TWO_SIDED|95.0|-0.1162|0.3628|||Repeated measure mixed model|||For Frontal lobe, APOE Epsilon-4 status positive||0.3628|-0.1162|0.3064
73894937|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1734||||0.35|TWO_SIDED|95.0|-0.1952|0.542|||Repeated measure mixed model|||For Frontal lobe APOE Epsilon-4 status negative||0.5420|-0.1952|0.3500
73894938|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.13||||0.2487|TWO_SIDED|95.0|-0.0937|0.3538|||Repeated measure mixed model|||For parietal lobe, APOE Epsilon-4 status positive||0.3538|-0.0937|0.2487
73894939|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1038||||0.5521|TWO_SIDED|95.0|-0.244|0.4516|||Repeated measure mixed model|||For parietal lobe, APOE Epsilon-4 status negative||0.4516|-0.2440|0.5521
73894940|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1384||||0.176|TWO_SIDED|95.0|-0.064|0.3409|||Repeated measure mixed model|||For posterior temporal lobe, APOE Epsilon-4 status positive||0.3409|-0.0640|0.1760
73894941|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0837||||0.5952|TWO_SIDED|95.0|-0.2303|0.3978|||Repeated measure mixed model|||For posterior temporal lobe, APOE Epsilon-4 status negative||0.3978|-0.2303|0.5952
73894942|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0847||||0.4025|TWO_SIDED|95.0|-0.1169|0.2863|||Repeated measure mixed model|||For Cerebellum, APOE Epsilon-4 status positive||0.2863|-0.1169|0.4025
73894943|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1536||||0.3081|TWO_SIDED|95.0|-0.1458|0.453|||Repeated measure mixed model95|||For Cerebellum, APOE Epsilon-4 status negative||0.4530|-0.1458|0.3081
73894944|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0839||||0.2964|TWO_SIDED|95.0|-0.0758|0.2436|||Repeated measure mixed model|||For medial temporal lobe, APOE Epsilon-4 status positive||0.2436|-0.0758|0.2964
73894945|NCT00265148|147322650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1536||||0.2101|TWO_SIDED|95.0|-0.0892|0.3963|||Repeated measure mixed model|||For medial temporal lobe, APOE Epsilon-4 status negative||0.3963|-0.0892|0.2101
73894946|NCT01068964|147322670|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 1.5 mmHg was used. That is, if the upper limit of the 95% confidence interval for the difference in the mean diurnal IOP change between the two groups (Group 1 minus Group 2) is less than 1.5 mm Hg, then the null hypothesis will be rejected. The study had an 85% power.|Mean Difference (Final Values)|-0.556|||||TWO_SIDED|95.0|-1.68|0.57||||||A non-inferiority test was performed for comparing the change from baseline in mean diurnal IOP at Week 4 between treatment groups. The null hypothesis was that the mean diurnal IOP change at Week 4 for Group 1 was at least 1.5 mmHg greater than that for Group 2. The hypothesis was tested using a confidence interval approach based on a 2-way analysis of variance (ANOVA) model including factors for treatment and investigator.||0.57|-1.68|
73894947|NCT03630770|147322671|OTHER||Rate Ratio|0.98||||0.9|TWO_SIDED|95.0|0.55|1.7||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the control group.||1.7|0.55|0.9
73894948|NCT03630770|147322671|OTHER||Rate Ratio|8.1|||<|0.001|TWO_SIDED|95.0|2.6|25.0||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the control group.||25|2.6|<0.001
73894949|NCT03630770|147322671|OTHER||Rate Ratio|0.15||||0.02|TWO_SIDED|95.0|0.03|0.75||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the MCT group.||0.75|0.03|0.02
73894950|NCT03630770|147322671|OTHER||Rate Ratio|61.0|||<|0.001|TWO_SIDED|95.0|6.9|533.0||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the MCT group.||533|6.9|<0.001
73802459|NCT03296527|147154045|SUPERIORITY||Mean ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.89|0.95||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH at end-of-stimulation||0.95|0.89|<0.001
73802460|NCT03296527|147154046|SUPERIORITY||Mean ratio|1.03||||0.184|TWO_SIDED|95.0|0.99|1.07||The p-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH at oocyte retrieval visit||1.07|0.99|0.184
73894951|NCT00606905|147322686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.05|TWO_SIDED|95.0|0.41|4.61|||Chi-squared|||||4.61|0.41|<0.05
73894952|NCT03255629|147322695|OTHER|||||||0.103|||||||McNemar|||||||0.103
73802461|NCT03296527|147154047|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value is based on van Elteren test adjusted for AMH group.||Total gonadotropin dose||||<.001
73894953|NCT03255629|147322696|OTHER|||||||0.18|||||||McNemar|||||||0.180
73894954|NCT03255629|147322698|OTHER|||||||0.317|||||||McNemar|||||||0.317
73894955|NCT03255629|147322699|OTHER|||||||0.008|||||||McNemar|||||||0.008
73894956|NCT03255629|147322700|OTHER|||||||0.083|||||||McNemar|||||||0.083
73894957|NCT03255629|147322701|OTHER|||||||0.025|||||||McNemar|||||||0.025
73802462|NCT03296527|147154049|SUPERIORITY|Treatment groups were compared using the van Elteren test.||||||0.001|||||||van Elteren|p-value is based on van Elteren test adjusted for AMH group.||Number of stimulation days||||0.001
73894958|NCT03255629|147322703|OTHER|||||||0.049|||||||Mixed Models Analysis|Linear mixed effects models to account for correlation within subjects over time||||||0.049
73894959|NCT03255629|147322704|OTHER|||||||0.056|||||||Mixed Models Analysis|Linear mixed effects models to account for correlation within subjects over time||||||0.056
73894960|NCT03255629|147322705|OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
73802463|NCT00122382|147154077|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|15.1|||<|0.001|TWO_SIDED|95.0|6.0|24.2||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving an ACR 50 response.||24.2|6.0|<0.001
73802464|NCT00122382|147154078|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|15.5|||<|0.001|TWO_SIDED|95.0|8.2|22.8||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving MCR.||22.8|8.2|<0.001
73894961|NCT03255629|147322706|OTHER|||||||0.059|||||||Mixed Models Analysis|||||||0.059
73894962|NCT03255629|147322707|OTHER|||||||0.195|||||||Mixed Models Analysis|||||||0.195
73894963|NCT03255629|147322708|OTHER|||||||0.043|||||||Mixed Models Analysis|||||||0.043
73894964|NCT03255629|147322709|OTHER|||||||0.659|||||||Mixed Models Analysis|||||||0.659
73894965|NCT03255629|147322710|OTHER|||||||0.406|||||||Mixed Models Analysis|||||||0.406
73894966|NCT03255629|147322711|OTHER|||||||0.611|||||||Mixed Models Analysis|||||||0.611
73894967|NCT03255629|147322712|OTHER|||||||0.183|||||||Mixed Models Analysis|||||||0.183
73894968|NCT03255629|147322713|OTHER|||||||0.009|||||||Mixed Models Analysis|||||||0.009
73894969|NCT03255629|147322714|OTHER|||||||0.789|||||||Mixed Models Analysis|||||||0.789
73894970|NCT03255629|147322715|OTHER|||||||0.865|||||||McNemar|||||||0.865
73894971|NCT03255629|147322716|OTHER|||||||0.875|||||||McNemar|||||||0.875
73894972|NCT01147627|147322718|NON_INFERIORITY_OR_EQUIVALENCE|108 patients in each group was needed to provide 90% power to detect non-inferiority of exenatide, shown by a mean difference of 0.4% in HbA1c change from baseline.|||||<|0.05||95.0|||||ANCOVA|||||||<0.05
73894973|NCT01024309|147322743|SUPERIORITY_OR_OTHER|||||||0.04||||||Apriori level of significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum was used||||||.04
73894974|NCT01024309|147322744|SUPERIORITY_OR_OTHER|||||||0.08||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test||||||0.08
73894975|NCT01024309|147322745|SUPERIORITY_OR_OTHER|||||||0.04||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.04
73894976|NCT01024309|147322746|SUPERIORITY_OR_OTHER|||||||0.22||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.22
73894977|NCT01024309|147322747|SUPERIORITY_OR_OTHER|||||||0.0029||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||.0029
73894978|NCT01024309|147322748|SUPERIORITY_OR_OTHER|||||||0.13||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.13
73894979|NCT01024309|147322749|SUPERIORITY_OR_OTHER|||||||0.29||||||a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum||||||0.29
73894980|NCT01024309|147322750|SUPERIORITY_OR_OTHER|||||||0.23||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.23
73894981|NCT01024309|147322751|SUPERIORITY_OR_OTHER|||||||0.49||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcox Rank Sum Test||||||0.49
73802465|NCT00122382|147154079|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-0.98|-0.48||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||||-0.48|-0.98|<0.001
73802466|NCT00122382|147154080|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|9.8||||0.024|TWO_SIDED|95.0|1.3|18.4||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving HAQ response.||18.4|1.3|0.024
73894982|NCT02737891|147322752|SUPERIORITY||Mean Difference (Net)|-3.8||||0.004|TWO_SIDED|95.0|-6.36|-1.29||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||-1.29|-6.36|0.004
73894983|NCT02737891|147322753|SUPERIORITY||Mean Difference (Net)|0.1||||0.724|TWO_SIDED|95.0|-0.23|0.33||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||0.33|-0.23|0.724
73894984|NCT02737891|147322754|SUPERIORITY||Mean Difference (Net)|-3.5|||<|0.0001|TWO_SIDED|95.0|-4.65|-2.3||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||-2.30|-4.65|<0.0001
73894985|NCT00244140|147322796|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR1|95.8||||||95.0|93.3|97.6||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).||97.6|93.3|
73802467|NCT00122382|147154081|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|2.5||||0.005|TWO_SIDED|95.0|0.77|4.23||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||PCS Adjusted Mean Change from Baseline to Month 12||4.23|0.77|0.005
73894986|NCT00244140|147322796|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR2|96.3||||||95.0|93.9|98.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).||98.0|93.9|
73894987|NCT00244140|147322796|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR3|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).||99.4|96.6|
73894988|NCT00244140|147322797|SUPERIORITY_OR_OTHER||Percent Images Rated Yes|99.7||||||95.0|98.6|100.0||||||||100.0|98.6|
73894989|NCT00244140|147322798|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent|99.5||||||95.0|98.1|99.9||||||||99.9|98.1|
73894990|NCT00244140|147322799|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR1|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).||99.4|96.6|
73894991|NCT00244140|147322799|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR2|100.0||||||95.0|99.0|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).||100.0|99.0|
73894992|NCT00244140|147322799|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR3|99.7||||||95.0|98.6|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).||100.0|98.6|
73894993|NCT02693132|147322800|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73894994|NCT02693132|147322801|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73894995|NCT02693132|147322802|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73894996|NCT02693132|147322803|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73894997|NCT02693132|147322804|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73894998|NCT04556383|147322805|SUPERIORITY||Risk Difference (RD)|-2.6||||0.6694|TWO_SIDED|95.0|-15.2|10.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||10.2|-15.2|0.6694
73894999|NCT04556383|147322805|SUPERIORITY||Risk Difference (RD)|4.6||||0.4719|TWO_SIDED|95.0|-9.0|17.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||17.8|-9.0|0.4719
73895000|NCT04556383|147322807|SUPERIORITY||Risk Difference (RD)|-7.7||||0.3263|TWO_SIDED|95.0|-23.2|8.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||8.3|-23.2|0.3263
73895001|NCT04556383|147322807|SUPERIORITY||Risk Difference (RD)|10.2||||0.2002|TWO_SIDED|95.0|-6.1|25.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||25.8|-6.1|0.2002
73895002|NCT04556383|147322808|SUPERIORITY||Risk Difference (RD)|0.4||||0.9472|TWO_SIDED|95.0|-15.2|15.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||15.9|-15.2|0.9472
73895003|NCT04556383|147322808|SUPERIORITY||Risk Difference (RD)|6.8||||0.3685|TWO_SIDED|95.0|-9.3|22.4|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||22.4|-9.3|0.3685
73895004|NCT04556383|147322809|SUPERIORITY||Risk Difference (RD)|1.3||||0.8484|TWO_SIDED|95.0|-12.7|15.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||15.2|-12.7|0.8484
73895005|NCT04556383|147322809|SUPERIORITY||Risk Difference (RD)|8.2||||0.2392|TWO_SIDED|95.0|-6.4|22.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||22.3|-6.4|0.2392
73895006|NCT04556383|147322810|SUPERIORITY||Risk Difference (RD)|-1.2||||0.8493|TWO_SIDED|95.0|-14.8|12.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||12.5|-14.8|0.8493
73895007|NCT04556383|147322810|SUPERIORITY||Risk Difference (RD)|2.6||||0.6647|TWO_SIDED|95.0|-11.5|16.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||16.5|-11.5|0.6647
73895008|NCT04556383|147322811|SUPERIORITY||Risk Difference (RD)|-6.5||||0.2263|TWO_SIDED|95.0|-19.1|6.0|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||6.0|-19.1|0.2263
73802468|NCT00122382|147154081|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|1.81||||0.046|TWO_SIDED|95.0|0.03|3.6||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||MCS Adjusted Mean Change from Baseline to Month 12||3.60|0.03|0.046
73895009|NCT04556383|147322811|SUPERIORITY||Risk Difference (RD)|-1.4||||0.8259|TWO_SIDED|95.0|-14.8|12.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||12.2|-14.8|0.8259
73895010|NCT04556383|147322812|SUPERIORITY||Risk Difference (RD)|2.8||||0.7418|TWO_SIDED|95.0|-12.7|18.1|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||18.1|-12.7|0.7418
73895011|NCT04556383|147322812|SUPERIORITY||Risk Difference (RD)|8.4||||0.2758|TWO_SIDED|95.0|-7.8|24.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||24.2|-7.8|0.2758
73895012|NCT04556383|147322813|SUPERIORITY||Risk Difference (RD)|-6.0||||0.3504|TWO_SIDED|95.0|-20.6|8.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||8.9|-20.6|0.3504
73895013|NCT04556383|147322813|SUPERIORITY||Risk Difference (RD)|1.7||||0.8009|TWO_SIDED|95.0|-14.2|17.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||17.5|-14.2|0.8009
73895014|NCT04556383|147322814|SUPERIORITY||Risk Difference (RD)|-0.2||||0.9474|TWO_SIDED|95.0|-14.3|13.7|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||13.7|-14.3|0.9474
73895015|NCT04556383|147322814|SUPERIORITY||Risk Difference (RD)|-3.0||||0.6409|TWO_SIDED|95.0|-16.6|10.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||10.8|-16.6|0.6409
73895016|NCT04556383|147322815|SUPERIORITY||Risk Difference (RD)|-8.0||||0.1932|TWO_SIDED|95.0|-22.4|6.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||6.3|-22.4|0.1932
73895017|NCT04556383|147322815|SUPERIORITY||Risk Difference (RD)|-2.3||||0.7459|TWO_SIDED|95.0|-17.6|12.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||12.9|-17.6|0.7459
73895018|NCT01994889|147322817|SUPERIORITY|||||||0.0006|||||||Finkelstein-Schoenfeld Method|||||||0.0006
73895019|NCT01994889|147322818|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.0259|TWO_SIDED|95.0|0.508|0.958|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.958|0.508|0.0259
73895020|NCT01994889|147322819|SUPERIORITY||Risk Ratio (RR)|0.6761|||<|0.0001|TWO_SIDED|95.0|0.5639|0.8107||Poisson regression analysis with treatment, TTR genotype, NYHA baseline classification, treatment-by-TTR genotype interaction, and treatment-by-NYHA baseline classification interaction terms as factors adjusted for treatment duration.|Poisson regression analysis|||||0.8107|0.5639|<0.0001
73895021|NCT01994889|147322820|SUPERIORITY||Least Square Mean Difference|75.68|STANDARD_ERROR_OF_MEAN|9.236|<|0.0001|TWO_SIDED|95.0|57.56|93.8|||Mixed Model Repeated Measures ANCOVA|||L.S. means are from an ANCOVA (MMRM) model with an unstructured covariance matrix; center and participant within center as random effects; treatment, visit, TTR genotype (variant and wild-type), and visit by treatment interaction, as fixed effects and baseline score as covariate.||93.80|57.56|<.0001
73895022|NCT01994889|147322821|SUPERIORITY||LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|2.13|<|0.0001|TWO_SIDED|95.0|9.48|17.83|||Mixed Model Repeated Measures ANCOVA|||Change at Month 30||17.83|9.48|<.0001
73895023|NCT01994889|147322822|SUPERIORITY||Hazard Ratio (HR)|0.691||||0.0383|TWO_SIDED|95.0|0.488|0.98|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.980|0.488|0.0383
73895024|NCT01994889|147322823|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73895025|NCT00744042|147322842|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Testing whether median change in rickets severity from Baseline to Week 24, measured by RGI-C at Week 24, is from zero.|Wilcoxon signed-rank test|The last post-baseline observation carry forward method is used; patients with no post-baseline assessments were imputed as having no change.||One treatment group||||0.0039
73895026|NCT03158285|147322858|SUPERIORITY||Difference in percentage|31.2|||<|0.001|TWO_SIDED|95.0|22.9|39.5|||Cochran-Mantel-Haenszel|||||39.5|22.9|< 0.001
73895027|NCT03158285|147322858|SUPERIORITY||Difference in percentage|30.8|||<|0.001|TWO_SIDED|95.0|22.4|39.1|||Cochran-Mantel-Haenszel|||||39.1|22.4|< 0.001
73895028|NCT03158285|147322859|SUPERIORITY||Least Square (LS) Mean difference|-0.2372|||<|0.001|TWO_SIDED|95.0|-0.321|-0.1534|||ANCOVA|||||-0.1534|-0.3210|< 0.001
73895029|NCT03158285|147322859|SUPERIORITY||LS Mean difference|-0.2704|||<|0.001|TWO_SIDED|95.0|-0.3544|-0.1864|||ANCOVA|||||-0.1864|-0.3544|< 0.001
73895030|NCT03158285|147322860|SUPERIORITY||Difference in percentage|17.2|||<|0.001||95.0|10.0|24.4||Nominal|Cochran-Mantel-Haenszel|||||24.4|10.0|< 0.001
73895031|NCT03158285|147322860|SUPERIORITY||Difference in percentage|18.8|||<|0.001|TWO_SIDED|95.0|11.5|26.1||Nominal|Cochran-Mantel-Haenszel|||||26.1|11.5|< 0.001
73895032|NCT03158285|147322861|SUPERIORITY||Difference in percentage|50.9|||<|0.001|TWO_SIDED|95.0|42.2|59.7|||Cochran-Mantel-Haenszel|||||59.7|42.2|<0.001
73895033|NCT03158285|147322861|SUPERIORITY||Difference in percentage|49.8|||<|0.001|TWO_SIDED|95.0|41.2|58.4|||Cochran-Mantel-Haenszel|||||58.4|41.2|< 0.001
73895034|NCT03158285|147322862|SUPERIORITY||Difference in percentage|21.5|||<|0.001|TWO_SIDED|95.0|13.1|30.0||Nominal|Cochran-Mantel-Haenszel|||||30.0|13.1|< 0.001
73895035|NCT03158285|147322862|SUPERIORITY||Difference in percentage|22.2|||<|0.001|TWO_SIDED|95.0|13.7|30.7||Nominal|Cochran-Mantel-Haenszel|||||30.7|13.7|< 0.001
73895036|NCT03158285|147322863|SUPERIORITY||LS Mean difference|-0.43||||0.072|TWO_SIDED|95.0|-0.9|0.03|||ANCOVA|||||0.03|-0.90|0.072
73895037|NCT03158285|147322863|SUPERIORITY||LS Mean difference|-0.66||||0.011|TWO_SIDED|95.0|-1.13|-0.19|||ANCOVA|||||-0.19|-1.13|0.011
73895038|NCT03158285|147322864|SUPERIORITY||Difference in response rates|20.1||||0.03|TWO_SIDED|95.0|11.8|28.5|||Cochran-Mantel-Haenszel|||||28.5|11.8|0.030
73895039|NCT03158285|147322864|SUPERIORITY||Difference in response rates|14.6||||0.03|TWO_SIDED|95.0|6.4|22.7|||Cochran-Mantel-Haenszel|||||22.7|6.4|0.030
73802469|NCT00122382|147154082|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value of \<0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in erosion scores between abatacept and placebo||||0.033
73802470|NCT00122382|147154082|SUPERIORITY_OR_OTHER|||||||0.353||95.0||||P-value of \<0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in JSN scores between abatacept and placebo||||0.353
73895040|NCT03158285|147322865|SUPERIORITY||Difference in response rates|18.0||||0.03|TWO_SIDED|95.0|7.4|28.6|||Cochran-Mantel-Haenszel|||||28.6|7.4|0.030
73895041|NCT03158285|147322865|SUPERIORITY||Difference in response rates|21.3||||0.011|TWO_SIDED|95.0|10.5|32.0|||Cochran-Mantel-Haenszel|||||32.0|10.5|0.011
73895042|NCT03158285|147322866|SUPERIORITY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.77|-0.23||Nominal|ANCOVA|||||-0.23|-0.77|< 0.001
73895043|NCT03158285|147322866|SUPERIORITY||LS Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.83|-0.31||Nominal|ANCOVA|||||-0.31|-0.83|< 0.001
73895044|NCT03158285|147322867|SUPERIORITY||LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.99|-0.79||Nominal|ANCOVA|||||-0.79|-2.99|< 0.001
73895045|NCT03158285|147322867|SUPERIORITY||LS Mean Difference|-1.77||||0.002|TWO_SIDED|95.0|-2.87|-0.66||Nominal|ANCOVA|||||-0.66|-2.87|0.002
73895046|NCT03158285|147322868|SUPERIORITY||LS Mean difference|3.97||||0.011|TWO_SIDED|95.0|2.75|5.2|||ANCOVA|||||5.20|2.75|0.011
73895047|NCT03158285|147322868|SUPERIORITY||LS Mean difference|3.62||||0.011|TWO_SIDED|95.0|2.39|4.85|||ANCOVA|||||4.85|2.39|0.011
73895048|NCT03158285|147322869|SUPERIORITY||LS Mean difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.8|-0.43||Nominal|ANCOVA|||||-0.43|-0.80|< 0.001
73895049|NCT03158285|147322869|SUPERIORITY||LS Mean difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.83|-0.47||Nominal|ANCOVA|||||-0.47|-0.83|< 0.001
73895050|NCT03158285|147322870|SUPERIORITY||LS Mean difference|2.02||||0.072|TWO_SIDED|95.0|0.56|3.49|||ANCOVA|||||3.49|0.56|0.072
73895051|NCT03158285|147322870|SUPERIORITY||LS Mean difference|2.07||||0.072|TWO_SIDED|95.0|0.6|3.54|||ANCOVA|||||3.54|0.60|0.072
73895052|NCT03158285|147322871|SUPERIORITY||Difference in percentage|19.3|||<|0.001|TWO_SIDED|95.0|12.6|25.9||Nominal|Cochran-Mantel-Haenszel|||||25.9|12.6|< 0.001
73895053|NCT03158285|147322871|SUPERIORITY||Difference in percentage|11.5|||<|0.001|TWO_SIDED|95.0|5.2|17.7||Nominal|Cochran-Mantel-Haenszel|||||17.7|5.2|< 0.001
73895054|NCT03158285|147322872|SUPERIORITY||Difference in percentage|14.5|||<|0.001|TWO_SIDED|95.0|9.1|19.9||Nominal|Cochran-Mantel-Haenszel|||||19.9|9.1|< 0.001
73895055|NCT03158285|147322872|SUPERIORITY||Difference in percentage|9.0|||<|0.001|TWO_SIDED|95.0|4.1|13.8||Nominal|Cochran-Mantel-Haenszel|||||13.8|4.1|< 0.001
73895056|NCT03009396|147323077|SUPERIORITY|||||||0.2112|||||||Log Rank|||||||0.2112
73895057|NCT03009396|147323078|SUPERIORITY|||||||0.0356|||||||Log Rank|||||||0.0356
73895058|NCT03009396|147323079|SUPERIORITY|||||||0.0514|||||||Log Rank|||||||0.0514
73895059|NCT03009396|147323080|SUPERIORITY|||||||0.1259|||||||Log Rank|||||||0.1259
73895060|NCT03009396|147323081|SUPERIORITY|||||||0.4114|||||||Fisher Exact|||||||0.4114
73895061|NCT01808092|147323144|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-4.2||||0.007|TWO_SIDED|95.0|-10.76|2.46||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \<= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in cMITT analysis set||2.46|-10.76|0.007
73895062|NCT01808092|147323145|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-0.7|||<|0.001|TWO_SIDED|95.0|-7.86|6.39||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \<= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in CE at TOC analysis set||6.39|-7.86|<0.001
73895063|NCT03952039|147323193|SUPERIORITY||Difference in Proportion|29.6|||<|0.0001|TWO_SIDED|95.0|19.9|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||Stratified analysis (based on CRF)||39.4|19.9|<0.0001
73895064|NCT03952039|147323194|SUPERIORITY|Stratified analysis (based on CRF)|Difference in Proportion|17.1||||0.0033|TWO_SIDED|95.0|4.8|29.4|||Cochran-Mantel-Haenszel|CMH test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||||29.4|4.8|0.0033
73895065|NCT03952039|147323195|SUPERIORITY||Difference in Proportion|33.5|||<|0.0001|TWO_SIDED|95.0|21.9|45.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||Stratified analysis (based on CRF)||45.1|21.9|<0.0001
73895066|NCT03952039|147323198|SUPERIORITY||Greenland and Robins method|19.9|||||TWO_SIDED|95.0|10.0|29.7|||Greenland and Robins method|||||29.7|10.0|
73895067|NCT01888432|147323215|NON_INFERIORITY|HO: πT - πC ≥ 0.12 vs. HA: πT - πC \< 0.12, where πT and πC are the true proportions of composite efficacy failure of tBPAR, GL, or D, (tBPAR/GL/D) at 12 months post-transplant for the respective treatment groups. The proportion of 0.12, or 12%, was pre-determined as the non-inferiority (NI) margin for composite efficacy failure.|Kaplan-Meier|-0.7|||<|0.001|TWO_SIDED|90.0|-5.2|3.7||Z-test p-value for non-inferiority test (non-inferiority margin = 12%) is for one-sided test and should be compared to 0.05 significance level.|Z-test|||non-inferior efficacy failure of the reduced tacrolimus regimen to control by rejecting the null hypothesis.||3.7|-5.2|< 0.001
73895068|NCT01888432|147323216|NON_INFERIORITY|the null hypothesis below was tested at the one-sided α = 0.05 level: H0: μT - μC ≤ -6 mL/min/1.73 m2 vs. HA: μT - μC \> -6 mL/min/1.73 m\^2, where μT and μC are the true means of change in eGFR (MDRD-4) from randomization to Month 12 post-transplant for the reduced tacrolimus group and control group, respectively.|Mean Difference (Net)|4.15|STANDARD_ERROR_OF_MEAN|2.574|<|0.001|TWO_SIDED|90.0|-0.09|8.4|||ANCOVA|||||8.40|-0.09|< 0.001
73895069|NCT01888432|147323217|OTHER||Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|2.699|<|0.001|TWO_SIDED|90.0|-1.21|7.7|||ANCOVA|||||7.70|-1.21|<0.001
73895070|NCT01888432|147323219|OTHER|Month 12|Kaplan-Meier|-1.4|||||TWO_SIDED|90.0|-4.7|2.0|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||2.0|-4.7|
73802471|NCT00122382|147154084|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|18.1|||<|0.001|TWO_SIDED|95.0|9.6|26.6||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving DAS28-CRP remission.||26.6|9.6|<0.001
73802472|NCT00122382|147154085|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|non-parametric ANCOVA|||||||<0.040
73802473|NCT00122382|147154100|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||signed rank test|||||||<0.001
73895071|NCT01888432|147323219|OTHER|tBPAR - month 24|Kaplan-Meier|-1.2|||||TWO_SIDED|90.0|-5.1|2.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||2.6|-5.1|
73802474|NCT02040805|147154103|NON_INFERIORITY|Margin based on clinically meaningful change of \>= 5 points.||||||0.04|||||||t-test, 1 sided|||Test of non-inferiority.||||0.04
73802475|NCT02040805|147154104|NON_INFERIORITY|Margin based on clinically meaningful change of \>= 2.5 points.||||||0.05|||||||t-test, 1 sided|||Test of non-inferiority.||||0.05
73895072|NCT01888432|147323219|OTHER|On-treatment tBPAR - month 24|Kaplan-Meier|-2.1|||||TWO_SIDED|90.0|-5.7|1.4|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||1.4|-5.7|
73895073|NCT01888432|147323220|OTHER|Month 12|Kaplan-Meier|0.9|||||TWO_SIDED|90.0|-3.4|5.1|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||5.1|-3.4|
73895074|NCT01888432|147323220|OTHER|Month 24|Kaplan-Meier|1.0|||||TWO_SIDED|90.0|-3.6|5.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||5.6|-3.6|
73895075|NCT01888432|147323221|OTHER|graft loss at month 24|Kaplan-Meier|-0.8|||||TWO_SIDED|90.0|-2.1|0.5|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||0.5|-2.1|
73895076|NCT01888432|147323222|OTHER|Month 12|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.8|-2.5|
73895077|NCT01888432|147323222|OTHER|Month 24|Kaplan-Meier|2.3|||||TWO_SIDED|90.0|-2.1|6.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||6.6|-2.1|
73895078|NCT01888432|147323223|OTHER|Month 12|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.8|-2.5|
73895079|NCT01888432|147323223|OTHER|Month 24|Kaplan-Meier|3.0|||||TWO_SIDED|90.0|-1.1|7.2|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||7.2|-1.1|
73802476|NCT02040805|147154105|OTHER|linear mixed models analysis|||||<|0.0001|||||||Mixed Models Analysis|df=1||||||<0.0001
73802477|NCT02040805|147154106|OTHER|linear mixed model|||||<|0.0001|||||||Mixed Models Analysis|df=1||||||<0.0001
73802478|NCT01008605|147154107|SUPERIORITY_OR_OTHER||Lower limit, 95% one-sided CI|95.83|||||ONE_SIDED|95.0|87.46||||||||||87.46|
73802479|NCT01213966|147154114|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||PPR24 was summarized descriptively. No statistical test was performed. The PRR24 values were summarised when the corresponding regression fit had a p-value of p ≤0.01 and an adjusted coefficient of determination (R2) ≥0.85.|Regression, Linear|||PPR24 was summarised descriptively. No statistical test was performed.||||0.01
73802480|NCT03655405|147154127|SUPERIORITY||Incidence Rate Ratio|0.972||||0.723|TWO_SIDED|95.0|0.83|1.138|||Regression, Poisson|Number of PIMs at follow-up, adjusted for baseline value||||1.138|0.830|0.723
73802481|NCT03655405|147154128|SUPERIORITY||Incidence Rate Ratio|0.763||||0.033|TWO_SIDED|95.0|0.594|0.979|||Regression, Poisson|Number of potentially inappropriate DDD at follow-up, adjusted for baseline value||||0.979|0.594|0.033
73802482|NCT03655405|147154129|SUPERIORITY||Incidence Rate Ratio|0.915||||0.064|TWO_SIDED|95.0|0.834|1.005|||Regression, Poisson|Number of chronic drugs at follow-up, adjusted for baseline value||||1.005|0.834|0.064
73802483|NCT03655405|147154130|SUPERIORITY||Incidence Rate Ratio|1.019||||0.857|TWO_SIDED|95.0|0.833|1.246|||Regression, Poisson|Number of chronic drugs at follow-up, adjusted for baseline value||||1.246|0.833|0.857
73802484|NCT03655405|147154132|SUPERIORITY||Slope|-1.36||||0.769|TWO_SIDED|95.0|-10.6|7.89|||Regression, Linear|Scale value at follow-up, adjusted for baseline value||Analysis for the scale component||7.89|-10.60|0.769
73802485|NCT03655405|147154132|SUPERIORITY||Slope|-0.096||||0.075|TWO_SIDED|95.0|-0.202|0.01|||Regression, Linear|Scale value at follow-up, adjusted for baseline value||Analysis for the index component||0.01|-0.202|0.075
73802486|NCT03655405|147154133|SUPERIORITY||Incidence Rate Ratio|1.237||||0.212|TWO_SIDED|95.0|0.886|1.727|||Mixed-effect regression, Poisson|Number at follow-up, adjusted for baseline value||||1.727|0.886|0.212
73802487|NCT03655405|147154134|SUPERIORITY||p-value|0.675||||0.675|TWO_SIDED||||||Fisher Exact|||||||0.675
73802488|NCT03655405|147154135|SUPERIORITY||p-value|0.615||||0.615|TWO_SIDED||||||Fisher Exact|||||||0.615
73802489|NCT03655405|147154136|SUPERIORITY||p-value|0.366||||0.366|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.366
73802490|NCT03655405|147154137|SUPERIORITY||p-value|0.738||||0.738|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.738
73802491|NCT03655405|147154138|SUPERIORITY||p-value|0.781||||0.781|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.781
73802492|NCT03655405|147154139|SUPERIORITY||p-value|0.958||||0.958|TWO_SIDED||||||Fisher Exact|||||||0.958
73802493|NCT03655405|147154140|SUPERIORITY||p-value|0.911||||0.911|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.911
73802494|NCT04390113|147154177|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6253|TWO_SIDED|95.0|0.55|1.55|||Log Rank|||||1.55|0.55|0.6253
73802495|NCT01611883|147154184|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Ezetimibe treatment group will be considered non-inferior to the placebo control group if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference (ezetimibe minus placebo) in means for change in HbA1c from baseline to the end of treatment does not exceed 0.5%.|Difference in Least-squares Means|0.08|||||TWO_SIDED|95.0|-0.07|0.23|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||0.23|-0.07|
73802496|NCT01611883|147154185|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|0.0|||||TWO_SIDED|95.0|-0.47|0.47|||Longitudinal analysis of covariance||ezetimibe minus placebo|||0.47|-0.47|
73802497|NCT01611883|147154186|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-4.8|||||TWO_SIDED|95.0|-12.1|2.5|||Longitudinal Analysis of Covariance||ezetimibe minus placebo|||2.5|-12.1|
73802498|NCT01611883|147154187|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo||||0.779
73802499|NCT01611883|147154188|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo||||0.365
73802500|NCT01611883|147154189|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-21.05|||<|0.001|TWO_SIDED|95.0|-25.06|-17.03|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-17.03|-25.06|<0.001
73802501|NCT01611883|147154190|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-13.54|||<|0.001|TWO_SIDED|95.0|-16.66|-10.42|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-10.42|-16.66|<0.001
73802502|NCT01611883|147154191|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-11.36||||0.025|TWO_SIDED|95.0|-21.27|-1.44|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-1.44|-21.27|0.025
73802503|NCT01611883|147154192|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|2.45||||0.246|TWO_SIDED|95.0|-1.71|6.61|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||6.61|-1.71|0.246
73802504|NCT01611883|147154193|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-19.07|||<|0.001|TWO_SIDED|95.0|-22.71|-15.43|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-15.43|-22.71|<0.001
73802505|NCT00030901|147154195|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is adjusted for stratification factors age older than 60, African American, baseline PSA, and vitamin E supplementation.|Regression, Logistic|||With target sample size of 466 randomized patients (233 per arm), there is a 90% of power to detect a one-third reduction in the three-year incidence rate of prostate cancer. The alpha level is set at 0.025, one-sided.||||0.73
73802506|NCT01205776|147154201|NON_INFERIORITY|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Hazard Ratio (HR)|-3.1|||<|0.0001|TWO_SIDED|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Com-Nougue|||||||<0.0001
73802507|NCT01205776|147154213|NON_INFERIORITY|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Hazard Ratio (HR)|4.0||||0.011|TWO_SIDED|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Com-Nougue Approach|||||||0.011
73802508|NCT05142722|147154307|SUPERIORITY||Least Squares (LS) Means|-32.65|STANDARD_ERROR_OF_MEAN|1.602|<|0.0001|TWO_SIDED|95.0|-35.79|-29.5|||ANCOVA|||||-29.50|-35.79|<.0001
73802509|NCT05142722|147154308|SUPERIORITY||Least Squares (LS) Means|-33.78|STANDARD_ERROR_OF_MEAN|1.678|<|0.0001|TWO_SIDED|95.0|-37.07|-30.49|||ANCOVA|||||-30.49|-37.07|<.0001
73802510|NCT05142722|147154309|SUPERIORITY||Least Squares (LS) Means|-23.98|STANDARD_ERROR_OF_MEAN|1.979|<|0.0001|TWO_SIDED|95.0|-27.87|-20.09||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-20.09|-27.87|<.0001
73802511|NCT05142722|147154310|SUPERIORITY||Least Squares (LS) Means|-18.92|STANDARD_ERROR_OF_MEAN|0.936|<|0.0001|TWO_SIDED|95.0|-20.76|-17.09||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-17.09|-20.76|<.0001
73802512|NCT05142722|147154311|SUPERIORITY||Least Squares (LS) Means|-18.31|STANDARD_ERROR_OF_MEAN|1.057|<|0.0001|TWO_SIDED|95.0|-20.38|-16.23||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-16.23|-20.38|<.0001
73802513|NCT05142722|147154312|SUPERIORITY||Least Squares (LS) Means|-13.8|STANDARD_ERROR_OF_MEAN|1.219|<|0.0001|TWO_SIDED|95.0|-16.2|-11.41||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-11.41|-16.20|<.0001
73802514|NCT05142722|147154313|SUPERIORITY||Least Squares (LS) Means|-29.44|STANDARD_ERROR_OF_MEAN|1.251|<|0.0001|TWO_SIDED|95.0|-31.89|-26.99||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.99|-31.89|<.0001
73802515|NCT05142722|147154314|SUPERIORITY||Least Squares (LS) Means|-28.32|STANDARD_ERROR_OF_MEAN|1.339|<|0.0001|TWO_SIDED|95.0|-30.94|-25.69||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-25.69|-30.94|<.0001
73802516|NCT05142722|147154315|SUPERIORITY||Least Squares (LS) Means|-23.02|STANDARD_ERROR_OF_MEAN|1.564|<|0.0001|TWO_SIDED|95.0|-26.09|-19.95||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.95|-26.09|<.0001
73802517|NCT05142722|147154316|SUPERIORITY||Least Squares (LS) Means|136.26|STANDARD_ERROR_OF_MEAN|1.939|<|0.0001|TWO_SIDED|95.0|132.46|140.07||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||140.07|132.46|<.0001
73802518|NCT05142722|147154317|SUPERIORITY||Least Squares (LS) Means|134.43|STANDARD_ERROR_OF_MEAN|2.343|<|0.0001|TWO_SIDED|95.0|129.84|139.03||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||139.03|129.84|<.0001
73802519|NCT05142722|147154318|SUPERIORITY||Least Squares (LS) Means|122.04|STANDARD_ERROR_OF_MEAN|2.299|<|0.0001|TWO_SIDED|95.0|117.53|126.55||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||126.55|117.53|<.0001
73895080|NCT01888432|147323223|OTHER|Month 24 (On-treatment death)|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.9|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.9|-2.5|
73802520|NCT05142722|147154319|SUPERIORITY||Least Squares (LS) Means|-14.12|STANDARD_ERROR_OF_MEAN|20.183||0.4841|TWO_SIDED|95.0|-53.68|25.44||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints|ANCOVA|||||25.44|-53.68|0.4841
73802521|NCT01467713|147154371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.286|TWO_SIDED|98.3|0.42|1.39|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.39|0.42|0.286
73802522|NCT01467713|147154371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.332|TWO_SIDED|98.3|0.43|1.43|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.43|0.43|0.332
73802523|NCT01467713|147154371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.808|TWO_SIDED|98.3|0.6|1.86|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.86|0.60|0.808
73802524|NCT01467713|147154371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.286|TWO_SIDED|98.3|0.48|1.61|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.61|0.48|0.286
73802525|NCT01467713|147154371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.332|TWO_SIDED|98.3|0.42|1.49|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.49|0.42|0.332
73802526|NCT01467713|147154371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.808|TWO_SIDED|98.3|0.6|1.95|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.95|0.60|0.808
73802527|NCT01100086|147154394|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|102.0|||||TWO_SIDED|90.0|99.35|105.42|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||105.42|99.35|
73802528|NCT01100086|147154395|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.0|||||TWO_SIDED|90.0|94.94|101.19|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.19|94.94|
73895081|NCT01888432|147323224|OTHER||Risk Difference (RD)|0.7|||||TWO_SIDED|90.0|-3.9|5.3|||||Month 12|||5.3|-3.9|
73895082|NCT01888432|147323224|OTHER||Risk Difference (RD)|2.1|||||TWO_SIDED|90.0|-3.0|7.2|||||Month 24|||7.2|-3.0|
73895083|NCT01888432|147323225|OTHER||Risk Ratio (RR)|-0.7|||||TWO_SIDED|90.0|-4.5|3.1|||||Month 12|||3.1|-4.5|
73895084|NCT01888432|147323225|OTHER||Risk Ratio (RR)|0.0|||||TWO_SIDED|90.0|-4.2|4.2|||||Month 24|||4.2|-4.2|
73895085|NCT01888432|147323229|OTHER||Difference in Kaplan-Meier estimate|5.4|||||TWO_SIDED|95.0|-19.9|30.6|||||Composite endpoint|||30.6|-19.9|
73895086|NCT01888432|147323229|OTHER||Difference in Kaplan-Meier estimate|6.7|||||TWO_SIDED|95.0|-6.0|19.3|||||On-treatment composite endpoint|||19.3|-6.0|
73895087|NCT01888432|147323229|OTHER||Difference in Kaplan-Meier estimate|2.0|||||TWO_SIDED|95.0|-24.6|28.7|||||Graft loss/death|||28.7|-24.6|
73895088|NCT01888432|147323229|OTHER||Difference in Kaplan-Meier estimate|14.4|||||TWO_SIDED|95.0|-4.2|33.1|||||tBPAR|||33.1|-4.2|
73802529|NCT01100086|147154396|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.3|||||TWO_SIDED|90.0|95.2|101.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.48|95.20|
73802530|NCT01100086|147154396|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|98.3|||||TWO_SIDED|90.0|95.2|101.48|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.48|95.20|
73802531|NCT03158038|147154433|SUPERIORITY||Rate difference|0.0|||||TWO_SIDED|95.0|-6.7|1.9||||||||1.9|-6.7|
73802532|NCT03158038|147154434|SUPERIORITY||Rate difference|1.3|||||TWO_SIDED|95.0|-12.8|13.2||||||Statistical analysis up to Day 8||13.2|-12.8|
73802533|NCT03158038|147154434|SUPERIORITY||Rate difference|0.4|||||TWO_SIDED|95.0|-14.1|13.2||||||Statistical analysis up to Day 15||13.2|-14.1|
73802534|NCT02612623|147154487|OTHER||LSM Difference|-0.56|||||TWO_SIDED|95.0|-2.08|0.96|||||Gefapixant minus Placebo|Least squares mean (LSM) difference: Mixed effect repeated measures model (MMRM) uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.96|-2.08|
73802535|NCT02612623|147154487|OTHER||LSM Difference|-0.71|||||TWO_SIDED|95.0|-2.34|0.92|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.92|-2.34|
73802536|NCT02612623|147154487|OTHER||LSM Difference|-1.35|||||TWO_SIDED|95.0|-2.99|0.3|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.30|-2.99|
73802537|NCT02612623|147154487|OTHER||Percentage Change|-42.6|||||TWO_SIDED|95.0|-87.5|162.3|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||162.3|-87.5|
73895089|NCT01888432|147323229|OTHER||Difference in Kaplan-Meier estimate|11.1|||||TWO_SIDED|95.0|-9.4|31.6|||||Death|||31.6|-9.4|
73895090|NCT01888432|147323229|OTHER||Difference in Kaplan-Meier estimate|3.2|||||TWO_SIDED|95.0|-28.9|35.2|||||AR|||35.2|-28.9|
73802538|NCT02612623|147154487|OTHER||Percentage Change|-50.8|||||TWO_SIDED|95.0|-90.3|151.1|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||151.1|-90.3|
73802539|NCT02612623|147154487|OTHER||Percentage Change|-74.0|||||TWO_SIDED|95.0|-95.0|34.7|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||34.7|-95.0|
73802540|NCT05344560|147154547|NON_INFERIORITY|A non-inferiority margin of -5 points was used.|Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|2.018|||TWO_SIDED|95.0|-6.92|1.07|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test \[senofilcon A (C3) HEV chromophore\] minus Control \[senofilcon A (C3)\]|||1.07|-6.92|
73802541|NCT00360282|147154548|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Sign test|||||||0.007
73802542|NCT00360282|147154549|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Sign test|||||||.549
73802543|NCT00607620|147154562|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||||0.98|0.79|
73802544|NCT00607620|147154563|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-2.1|-0.3|||||The data represented refers to the group mean difference (intervention versus control) of the change score between baseline to 12-months.|||-0.3|-2.1|
73802545|NCT00607620|147154564|SUPERIORITY||Mean Difference (Net)|3.4|||||TWO_SIDED|95.0|0.4|6.4|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||6.4|0.4|
73802546|NCT00607620|147154565|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-3.3|1.9|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||1.9|-3.3|
73802547|NCT00607620|147154566|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-1.02|0.99|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||0.99|-1.02|
73802548|NCT01620138|147154567|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73802549|NCT00449865|147154581|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Global Statistical Test|The global statistical test yielded t = -0.75 (2-sided p-value = .45, df=1865.8).||||||0.45
73802551|NCT01766076|147154615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann Whitney test was used for nonparametric variables||||||<0.05
73895091|NCT01888432|147323229|OTHER||Difference in Kaplan-Meier estimate|14.4|||||TWO_SIDED|95.0|-4.2|33.1|||||tAR|||33.1|-4.2|
73895092|NCT01888432|147323229|OTHER||Difference in Kaplan-Meier estimate|14.9|||||TWO_SIDED|95.0|-22.3|52.1|||||BPR|||52.1|-22.3|
73895093|NCT01888432|147323229|OTHER||Difference in Kaplan-Meier estimate|3.2|||||TWO_SIDED|95.0|-28.9|35.2|||||BPAR|||35.2|-28.9|
73895094|NCT01888432|147323230|OTHER||Mean Difference (Final Values)|-10.01|STANDARD_ERROR_OF_MEAN|22.059|||TWO_SIDED|95.0|-59.91|39.89||||||||39.89|-59.91|
73895095|NCT03054129|147323231|SUPERIORITY|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
73895096|NCT03054129|147323232|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
73895097|NCT03054129|147323233|SUPERIORITY|||||||0.565|||||||Wilcoxon (Mann-Whitney)|||||||0.565
73895098|NCT03054129|147323234|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
73895099|NCT03054129|147323235|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
73802552|NCT01465412|147154647|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the least squares mean (LSM) Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.075|||||TWO_SIDED|90.0|0.695|1.662||||||The analysis was performed using an analysis of covariance (ANCOVA) model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, Body Mass Index (BMI) and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||1.662|0.695|
73802553|NCT01465412|147154647|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.598|||||TWO_SIDED|90.0|1.334|5.06||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||5.060|1.334|
73802554|NCT01465412|147154648|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.305|||||TWO_SIDED|90.0|0.84|2.027||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.027|0.840|
73802555|NCT01465412|147154648|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.434|||||TWO_SIDED|90.0|0.643|3.198||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||3.198|0.643|
73802556|NCT01465412|147154649|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.852|||||TWO_SIDED|90.0|0.81|4.234||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||4.234|0.810|
73802557|NCT01465412|147154649|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.392|||||TWO_SIDED|90.0|1.306|4.382||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||4.382|1.306|
73802558|NCT01465412|147154650|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.548|||||TWO_SIDED|90.0|0.918|2.61||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.610|0.918|
73802559|NCT01465412|147154650|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.407|||||TWO_SIDED|90.0|0.72|2.75||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||2.750|0.720|
73895100|NCT03054129|147323236|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
73895101|NCT03054129|147323237|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
73802560|NCT01465412|147154651|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.555|||||TWO_SIDED|90.0|0.617|3.917||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||3.917|0.617|
73802561|NCT01465412|147154651|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|4.806|||||TWO_SIDED|90.0|2.77|8.335||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||8.335|2.770|
73802562|NCT01465412|147154652|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.269|||||TWO_SIDED|90.0|0.703|2.288||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.288|0.703|
73802563|NCT01465412|147154652|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.98|||||TWO_SIDED|90.0|1.316|2.977||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||2.977|1.316|
73895102|NCT03054129|147323238|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||0.978
73895103|NCT03054129|147323239|SUPERIORITY|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
73895104|NCT03054129|147323240|SUPERIORITY|||||||0.097|||||||Wilcoxon (Mann-Whitney)|||||||0.097
73895105|NCT03054129|147323241|SUPERIORITY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|||||||0.339
73895106|NCT03054129|147323242|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
73895107|NCT03054129|147323243|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
73895108|NCT03054129|147323244|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
73895109|NCT03054129|147323245|SUPERIORITY|||||||0.673|||||||Wilcoxon (Mann-Whitney)|||||||0.673
73802564|NCT01465412|147154653|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.326|||||TWO_SIDED|90.0|0.749|2.348||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.348|0.749|
73802565|NCT01465412|147154653|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|4.041|||||TWO_SIDED|90.0|1.46|11.187||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||11.187|1.460|
73802566|NCT01465412|147154654|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.609|||||TWO_SIDED|90.0|1.007|2.572||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.572|1.007|
73802567|NCT01465412|147154654|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.231|||||TWO_SIDED|90.0|0.844|5.896||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||5.896|0.844|
73802568|NCT03817190|147154660|SUPERIORITY||Proportion of participants|-0.2277||||0.688|TWO_SIDED|95.0|-1.0415|0.586|||GLMM|||||0.5860|-1.0415|0.6880
73802569|NCT03817190|147154661|SUPERIORITY||Proportion of participants|-0.276||||0.4321|TWO_SIDED|95.0|-0.9185|0.3665|||GLMM|||||0.3665|-0.9185|0.4321
73802570|NCT01622673|147154673|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.678|||||TWO_SIDED|90.0|0.531|0.866|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for TUMS® + raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.866|0.531|
73802571|NCT01622673|147154673|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.373|||||TWO_SIDED|90.0|0.293|0.475|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean C12hrs for MINTOX® + raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.475|0.293|
73802572|NCT01622673|147154674|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.437|||||TWO_SIDED|90.0|0.344|0.554|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® before raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.554|0.344|
73802573|NCT01622673|147154674|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.433|||||TWO_SIDED|90.0|0.341|0.55|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® after raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.550|0.341|
73802574|NCT01622673|147154675|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.445|||||TWO_SIDED|90.0|0.35|0.565|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for TUMS® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.565|0.350|
73802575|NCT01622673|147154675|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.51|||||TWO_SIDED|90.0|0.402|0.646|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.646|0.402|
73802576|NCT01622673|147154676|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||TWO_SIDED|90.0|0.351|0.669|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® before raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.669|0.351|
73802577|NCT01622673|147154676|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.696|||||TWO_SIDED|90.0|0.504|0.96|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® after raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.960|0.504|
73802578|NCT01622673|147154677|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.476|||||TWO_SIDED|90.0|0.362|0.627|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for TUMS® + raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.627|0.362|
73802579|NCT01622673|147154677|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.555|||||TWO_SIDED|95.0|0.423|0.729|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean Cmax for MINTOX® + raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.729|0.423|
73802580|NCT01622673|147154678|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||TWO_SIDED|90.0|0.332|0.709|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® before raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.709|0.332|
73802581|NCT01622673|147154678|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.775|||||TWO_SIDED|90.0|0.53|1.132|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® after raltegravir / geometric least squares mean Cmax for raltegravir alone|||1.132|0.530|
73802582|NCT02565628|147154733|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.02|STANDARD_ERROR_OF_MEAN|10.49||0.6382|ONE_SIDED|90.0||8.97|||Mixed Models Analysis|||||8.97||0.6382
73802583|NCT00437021|147154749|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|0.97|1.99|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||1.99|0.97|
73802584|NCT00437021|147154750|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|2.895|||||TWO_SIDED|95.0|2.22|3.69|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||3.69|2.22|
73802585|NCT00437021|147154758|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|1.65|2.76|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||2.76|1.65|
73895110|NCT03054129|147323246|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
73895111|NCT03054129|147323247|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.040
73802586|NCT00437021|147154759|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|3.08|||||TWO_SIDED|95.0|2.57|3.59|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||3.59|2.57|
73802587|NCT04846569|147154775|SUPERIORITY||Mean Difference (Final Values)|0.004|||||TWO_SIDED|95.0|-0.38|0.39||||||||0.39|-0.38|
73802588|NCT04846569|147154776|SUPERIORITY||Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-0.78|0.47||||||||0.47|-0.78|
73802589|NCT04846569|147154777|SUPERIORITY|||||||||||||||||All participants who we were able to obtain records for were virally suppressed thus an effect size was unable to be calculated.|All participants who we were able to obtain records for were virally suppressed thus an effect size was unable to be calculated as originally planned.|||
73802590|NCT04846569|147154778|SUPERIORITY||Median Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.2|0.53||||||||0.53|-0.20|
73802591|NCT04846569|147154779|OTHER|Qualitative data analysis|||||||||||||||||Thematic qualitative data analysis was conducted to determine the count of participants reporting positively about the intervention|||
73802592|NCT02954601|147154792|OTHER|Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment, Period and Baseline value (for change and percent change) are factors in the model with repeated values for a subject.||||||0.1311|||||||Mixed Models Analysis|||||||0.1311
73802593|NCT02954601|147154795|OTHER|||||||0.3061|TWO_SIDED|95.0|||||Mixed Models Analysis|||Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment period and Baseline value (for change and percent change) are factors in the model with repeated values for subject.||||0.3061
73895112|NCT03054129|147323248|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||||||0.779
73895113|NCT03054129|147323249|SUPERIORITY|||||||0.152|||||||Wilcoxon (Mann-Whitney)|||||||0.152
73895114|NCT03054129|147323250|SUPERIORITY|||||||0.129|||||||Wilcoxon (Mann-Whitney)|||||||0.129
73895115|NCT03054129|147323251|SUPERIORITY|||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
73895116|NCT03054129|147323252|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||0.978
73895117|NCT03054129|147323253|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
73895118|NCT03054129|147323254|SUPERIORITY|||||||0.546|||||||Wilcoxon (Mann-Whitney)|||||||0.546
73895119|NCT03054129|147323255|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
73895120|NCT03054129|147323256|SUPERIORITY|||||||0.684|||||||Wilcoxon (Mann-Whitney)|||||||0.684
73802594|NCT04227197|147154801|SUPERIORITY|The p value compares the trend in the number of indicated or completed evaluations in the Intervention arm versus Control arm.||||||0.018|||||||Cochran-Armitage trend test|Two tailed; no continuity correction||||||0.018
73802595|NCT04227197|147154803|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group.||||||0.468|||||||ANOVA|||This is the p value for the PedsQL Psychosocial Health Score||||0.468
73802596|NCT04227197|147154803|SUPERIORITY|||||||0.802|||||||ANOVA|||This p value is for the PedsQL Physical Functioning Score||||0.802
73802597|NCT04227197|147154803|SUPERIORITY|||||||0.761|||||||ANOVA|||This is the p value for the PedsQL Total Scale Score||||0.761
73802598|NCT04227197|147154803|SUPERIORITY|||||||0.965|||||||ANOVA|||This is the p value for the PedsQL FIM Parental HRQL Summary Score||||0.965
73802599|NCT04227197|147154803|SUPERIORITY|||||||0.619|||||||ANOVA|||This is the p value for the PedsQL FIM Family Functioning Summary Score||||0.619
73802600|NCT04227197|147154803|SUPERIORITY|||||||0.469|||||||ANOVA|||This is the p value for the PedsQL FIM Total Scale Score||||0.469
73802601|NCT04227197|147154804|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.068|||||||ANOVA|||This is for the change from baseline on PedsQL Psychosocial Health Score||||0.068
73802602|NCT04227197|147154804|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.907|||||||ANOVA|||This is for the change from baseline for PedsQL Physical Functioning Score||||0.907
73895121|NCT03054129|147323257|SUPERIORITY|||||||0.112|||||||Wilcoxon (Mann-Whitney)|||||||0.112
73895122|NCT03054129|147323258|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
73802603|NCT04227197|147154804|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.196|||||||ANOVA|||This is for the change from baseline for PedsQL Total Scale Score||||0.196
73802604|NCT04227197|147154804|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.112|||||||ANOVA|||This is for the change from baseline for PedsQL FIM Parental HRQL Summary Score||||0.112
73802605|NCT04227197|147154804|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.245|||||||ANOVA|||This is for change from baseline for PedsQL FIM Family Functioning Summary Score||||0.245
73802606|NCT04227197|147154804|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.219|||||||ANOVA|||This is for change from baseline for PedsQL FIM Total Scale Score||||0.219
73802607|NCT00333983|147154806|SUPERIORITY_OR_OTHER|||||||0.025||||||P value was set at .025 to adjust for 2 treatment comparisons and for interim monitoring for the treatment effect.|Mixed Models Analysis|||An analysis of all robot interventions compared with intensive conventional exercise for Fugl-Meyer change were completed using linear mixed models.||||.025
73802608|NCT02992236|147154809|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
73802609|NCT03446027|147154812|OTHER|"Prespecified Tobit Regression mode: the model included the AWD baseline measurement, a treatment indicator and the type of centre (SET versus non-SET) as covariates. As the data collected for AWD showed a right-skewed distribution, a square root transformation was used to normalise the data and used for the regression Tobit model. This resulted in the unit of measure being units rather than meters."|square root transformation|0.835||||0.28|TWO_SIDED|95.0|-0.674|2.343|||Tobit Regression|||"Right censored Tobit regression model for AWD at 3 months for the ITT population.~Difference between arms (between baseline and 3 months) - the primary analysis estimates the difference in the AWD at 3 months between the two treatment groups control vs. device. Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET Included participants with both baseline and 3 month treadmill data."||2.343|-0.674|0.28
73802610|NCT03446027|147154813|OTHER|"Right censored, Tobit Regression model to assess the effects of baseline characteristics for ICD at 3 months for the ITT Population. This resulted in the unit of measure being units and not meters.~Included participants with both baseline and 3 month treadmill data. Calculation between arms - estimates the difference in the ICD at 3 months between the two treatment groups.~Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET"|square root transformation|0.972||||0.23|TWO_SIDED|95.0|-0.6|2.546|||Right censored, Tobit Regression|||||2.546|-0.600|0.23
73802611|NCT03446027|147154817|OTHER|"Linear Regression Model for Duplex ultrasonography (Volume flow - measured in one leg) at 3 months for the ITT population.~Difference (calculation) between the two groups and not per arm (control vs treatment). Unit of measure is Units due to the use of a linear regression model rather than cc/min."|Linear regression|0.483||||0.516|TWO_SIDED|95.0|-0.984|1.95|||Regression, Linear|||||1.950|-0.984|0.516
73802612|NCT02996968|147154883|NON_INFERIORITY|"Non-inferiority was declared if the POUR rate at 1-week with self-discontinuation was no worse than the POUR rate at 1-week with office-discontinuation, by a pre-specified margin of 15%.~A sample size was calculated to be 74 patients in each arm based on the following:~* The estimated POUR requiring indwelling urinary catheter at 1-week postoperative is 16%~* The non-inferiority margin was set at 15%.~* The power was set at 80%"|Proportion Difference|0.002||||0.5|ONE_SIDED|95.0||0.095||2-sample test for equality of proportions with continuity correction|Two proportions Z-test|||||0.095||0.5
73802613|NCT00444535|147154887|OTHER|Clopper-Pearson exact test (binomial)|Exact binomial procedure|69.2||||||95.0|54.9|81.3||||||||81.3|54.9|
73802614|NCT00558467|147154940|SUPERIORITY_OR_OTHER||Least Squares mean difference|0.01||||0.996|TWO_SIDED|95.0|-4.95|4.97|||ANCOVA|||||4.97|-4.95|0.996
73802615|NCT00558467|147154941|SUPERIORITY_OR_OTHER||Least square means difference|-3.94|||||TWO_SIDED|95.0|-5.81|-2.08|||Repeated Measures|||||-2.08|-5.81|
73802616|NCT00558467|147154942|SUPERIORITY_OR_OTHER||Least square means difference|-5.3|||||TWO_SIDED|95.0|-7.21|-3.39|||Repeated measures|||||-3.39|-7.21|
73895123|NCT03054129|147323259|SUPERIORITY|||||||0.633|||||||Wilcoxon (Mann-Whitney)|||||||0.633
73895124|NCT03054129|147323260|SUPERIORITY|||||||0.736|||||||Wilcoxon (Mann-Whitney)|||||||0.736
73895125|NCT03054129|147323261|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
73895126|NCT03054129|147323262|SUPERIORITY|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||||||0.109
73895127|NCT03054129|147323263|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||||||0.844
73895128|NCT03054129|147323264|SUPERIORITY|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||0.122
73802617|NCT00558467|147154944|SUPERIORITY_OR_OTHER||Least square means difference|-5.97|||||TWO_SIDED|95.0|-7.88|-4.06|||Repeated measures|||||-4.06|-7.88|
73802618|NCT00558467|147154945|SUPERIORITY_OR_OTHER||Least Squares Mean differnce|-0.15||||0.978|TWO_SIDED|95.0|-11.05|10.75|||ANCOVA|||||10.75|-11.05|0.9780
73802619|NCT00558467|147154950|SUPERIORITY_OR_OTHER|||||||0.1052|||||||Cochran-Mantel-Haenszel|||||||0.1052
73802620|NCT00558467|147154951|SUPERIORITY_OR_OTHER|||||||0.2274|||||||Cochran-Mantel-Haenszel|||||||0.2274
73802621|NCT00558467|147154952|SUPERIORITY_OR_OTHER|||||||0.7691|||||||Cochran-Mantel-Haenszel|||||||0.7691
73802622|NCT00558467|147154953|SUPERIORITY_OR_OTHER|||||||0.0674|||||||Cochran-Mantel-Haenszel|||||||0.0674
73802623|NCT00558467|147154954|SUPERIORITY_OR_OTHER|||||||0.4944|||||||Cochran-Mantel-Haenszel|||||||0.4944
73802624|NCT00558467|147154955|SUPERIORITY_OR_OTHER|||||||0.162|||||||Cochran-Mantel-Haenszel|||||||0.162
73802625|NCT00558467|147154956|SUPERIORITY_OR_OTHER|||||||0.6375|||||||Cochran-Mantel-Haenszel|||||||0.6375
73802626|NCT00558467|147154957|SUPERIORITY_OR_OTHER|||||||0.6625|||||||Cochran-Mantel-Haenszel|||||||0.6625
73895129|NCT03054129|147323265|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
73802627|NCT00558467|147154958|SUPERIORITY_OR_OTHER|||||||0.2664|||||||Cochran-Mantel-Haenszel|||||||0.2664
73802628|NCT00558467|147154959|SUPERIORITY_OR_OTHER|||||||0.7302|||||||Cochran-Mantel-Haenszel|||||||0.7302
73802629|NCT00558467|147154960|SUPERIORITY_OR_OTHER|||||||0.7723|||||||Cochran-Mantel-Haenszel|||||||0.7723
73802630|NCT00558467|147154961|SUPERIORITY_OR_OTHER|||||||0.4852|||||||Cochran-Mantel-Haenszel|||||||0.4852
73802631|NCT00558467|147154962|SUPERIORITY_OR_OTHER|||||||0.4607|||||||Cochran-Mantel-Haenszel|||||||0.4607
73802632|NCT00558467|147154963|SUPERIORITY_OR_OTHER|||||||0.7723|||||||Cochran-Mantel-Haenszel|||||||0.7723
73802633|NCT00558467|147154964|SUPERIORITY_OR_OTHER|||||||0.9389|||||||Cochran-Mantel-Haenszel|||||||0.9389
73802634|NCT02025725|147154976|SUPERIORITY|||||||0.881|||||||ANCOVA|||||||0.881
73802635|NCT02025725|147154977|SUPERIORITY||Mean Difference (Net)|-0.201||||0.036|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 1: metoclopramide nasal spray minus placebo.||||0.036
73802636|NCT02025725|147154977|SUPERIORITY||Mean Difference (Net)|-0.336||||0.025|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 2: metoclopramide nasal spray minus placebo||||0.025
73802637|NCT02025725|147154977|SUPERIORITY||Mean Difference (Net)|-0.347||||0.039|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 3: metoclopramide nasal spray minus placebo.||||0.039
73802638|NCT02025725|147154977|SUPERIORITY||Mean Difference (Net)|-0.364||||0.085|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 4: metoclopramide nasal spray minus placebo.||||0.085
73802639|NCT00343044|147154978|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED|||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Planned enrollment of 40 patients was determined assuming a median progression free survival (PFS) of 9 months (based on a median PFS of 7.2 months for low-dose, metronomic cyclophosphamide plus bevacizumab in a phase 2 study) and an analysis calculating the sample size at which the narrowing of its 95% confidence interval (CI) became greater than .2 for every 2 patients added. Progression free survival was estimated using the Kaplan-Meier method.||||.08
73802640|NCT00343044|147154979|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Overall survival(OS)was estimated using the Kaplan-Meier method.||||.02
73802641|NCT04556305|147155040|SUPERIORITY|||||||0.409|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.409
73802642|NCT04556305|147155040|SUPERIORITY|||||||0.456|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.456
73802643|NCT04556305|147155040|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.692
73802644|NCT04556305|147155041|SUPERIORITY|||||||0.179|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.179
73802645|NCT04556305|147155041|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.910
73802646|NCT04556305|147155041|SUPERIORITY|||||||0.159|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.159
73802647|NCT04556305|147155042|SUPERIORITY|||||||0.078|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.078
73802648|NCT04556305|147155042|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.130
73802649|NCT04556305|147155042|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.430
73802650|NCT04556305|147155043|SUPERIORITY|||||||0.772|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.772
73802651|NCT04556305|147155043|SUPERIORITY|||||||0.107|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.107
73802652|NCT04556305|147155043|SUPERIORITY|||||||0.915|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.915
73802653|NCT04556305|147155044|SUPERIORITY|||||||0.078|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.078
73802654|NCT04556305|147155044|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.130
73802655|NCT04556305|147155044|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.430
73895130|NCT03054129|147323266|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||0.593
73895131|NCT03054129|147323267|SUPERIORITY|||||||0.508|||||||Wilcoxon (Mann-Whitney)|||||||0.508
73802656|NCT04556305|147155045|SUPERIORITY|||||||0.487|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.487
73802657|NCT04556305|147155045|SUPERIORITY|||||||0.827|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.827
73802658|NCT04556305|147155045|SUPERIORITY|||||||0.908|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.908
73802659|NCT04556305|147155046|SUPERIORITY|||||||0.371|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.371
73802660|NCT04556305|147155046|SUPERIORITY|||||||0.633|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.633
73802661|NCT04556305|147155046|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.230
73802662|NCT04556305|147155047|SUPERIORITY|||||||0.798|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.798
73802663|NCT04556305|147155047|SUPERIORITY|||||||0.461|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.461
73802664|NCT04556305|147155047|SUPERIORITY|||||||0.419|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.419
73802665|NCT04556305|147155048|SUPERIORITY|||||||0.619|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.619
73802666|NCT04556305|147155048|SUPERIORITY|||||||0.468|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.468
73802667|NCT04556305|147155048|SUPERIORITY|||||||0.387|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.387
73802668|NCT04556305|147155049|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.380
73802669|NCT04556305|147155049|SUPERIORITY|||||||0.759|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.759
73802670|NCT04556305|147155049|SUPERIORITY|||||||0.219|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.219
73802671|NCT04556305|147155050|SUPERIORITY|||||||0.995|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.995
73802672|NCT04556305|147155050|SUPERIORITY|||||||0.946|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.946
73802673|NCT04556305|147155050|SUPERIORITY|||||||0.593|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.593
73802674|NCT04556305|147155051|SUPERIORITY|||||||0.092|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.092
73802675|NCT04556305|147155051|SUPERIORITY|||||||0.245|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.245
73802676|NCT04556305|147155051|SUPERIORITY|||||||0.107|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.107
73802677|NCT04556305|147155052|SUPERIORITY|||||||0.244|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.244
73802678|NCT04556305|147155052|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.085
73802679|NCT04556305|147155052|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.710
73802680|NCT04556305|147155053|SUPERIORITY|||||||0.491|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.491
73802681|NCT04556305|147155053|SUPERIORITY|||||||0.444|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.444
73802682|NCT04556305|147155053|SUPERIORITY|||||||0.279|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.279
73802683|NCT03808948|147155061|OTHER||Odds Ratio (OR)|0.62||||0.4842|TWO_SIDED|95.0|0.08|1.97|||Regression, Logistic|||Binary logistic regression with mGFR/eGFR ratio as independent variate, AKI as binary outcome||1.97|0.08|0.4842
73802684|NCT03982511|147155075|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.73|TWO_SIDED|||||Given that this is a pilot RCT, primary aim is to estimate effect sizes for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures|Effect size: 0.17|Difference on difference from T2 to T1 for BMI z-score||||.73
73802685|NCT03982511|147155075|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.98|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI z-score from T3 to T1|Effect size: -0.01|||.98
73802686|NCT03982511|147155075|SUPERIORITY||Mean Difference (Net)|1.93|STANDARD_ERROR_OF_MEAN|3.97||0.63|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI percentile from T2 to T1|Effect size: 0.24|||0.63
73802687|NCT03982511|147155075|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|4.51||0.96|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI percentile from T3 to T1|Effect size: 0.03|||0.96
73802688|NCT03982511|147155076|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for Emotion regulation subscale from T2 to T1|Effect size: 0.79|||0.12
73802689|NCT03982511|147155076|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.96|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for emotion regulation subscale from T3 to T1|Effect size: -0.02|||0.96
73802690|NCT03982511|147155077|SUPERIORITY||Mean Difference (Net)|-6.08|STANDARD_ERROR_OF_MEAN|5.42||0.28|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for child weekly screen time from T2 to T1|Effect size: -0.41|||0.28
73802691|NCT03982511|147155077|SUPERIORITY||Mean Difference (Net)|5.83|STANDARD_ERROR_OF_MEAN|7.17||0.43|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for child weekly screen time from T3 to T1|Effect size: 0.42|||0.43
73802692|NCT03982511|147155078|SUPERIORITY||Mean Difference (Net)|35.32|STANDARD_ERROR_OF_MEAN|23.86||0.16|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference score for MVPA minutes from T2 to T1|Effect size: 0.85|||0.16
73802693|NCT03982511|147155078|SUPERIORITY|Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|Mean Difference (Net)|16.09|STANDARD_ERROR_OF_MEAN|30.32||0.61|TWO_SIDED||||||ANOVA|Repeated measures||Difference on difference score for MVPA minutes from T3 to T1|Effect size: 0.35|||0.61
73802694|NCT03982511|147155078|SUPERIORITY||Mean Difference (Net)|-64.4|STANDARD_ERROR_OF_MEAN|54.5||0.26|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference score for sedentary minutes from T2 to T1|Effect size: -0.68|||0.26
73802695|NCT03982511|147155078|SUPERIORITY||Mean Difference (Net)|66.25|STANDARD_ERROR_OF_MEAN|66.43||0.34|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference score for sedentary minutes from T3 to T1|effect size: 0.66|||0.34
73802696|NCT03982511|147155079|SUPERIORITY||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|0.75||0.41|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for parent-reported sleep time from T2 to T1|effect size: -0.41|||0.41
73802697|NCT03982511|147155079|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|0.95||0.16|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for parent-reported sleep time from T3 to T1|effect size: 0.76|||0.16
73802698|NCT03982511|147155080|SUPERIORITY||Mean Difference (Net)|-12.62|STANDARD_ERROR_OF_MEAN|14.84||0.42|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for actigraphy-recorded sleep time from T2 to T1|effect size: -0.54|||0.42
73802699|NCT03982511|147155080|SUPERIORITY||Mean Difference (Net)|-38.83|STANDARD_ERROR_OF_MEAN|16.61||0.04|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for actigraphy-recorded sleep time from T3 to T1|effect size: -1.56|||0.04
73802700|NCT03982511|147155081|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.26||0.77|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for problematic media use from T2 to T1|effect size: 0.15|||0.77
73895132|NCT00130247|147323268|NON_INFERIORITY_OR_EQUIVALENCE|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.051||||||95.0|0.01|0.09|||Regression, Cox||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.|Comparison of binomial proportion of relapse: Intention-to-treat||0.09|0.01|
73802701|NCT03982511|147155081|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.28||0.47|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for problematic media use from T3 to T1|effect size: -0.38|||0.47
73802702|NCT03982511|147155082|SUPERIORITY||Mean Difference (Net)|9.11|STANDARD_ERROR_OF_MEAN|2.76||0.005|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for child-centered skills from T2 to T1|effect size: 1.65|||0.005
73802703|NCT03982511|147155082|SUPERIORITY||Mean Difference (Net)|8.22|STANDARD_ERROR_OF_MEAN|3.81||0.05|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for child-centered skills from T3 to T1|effect size: 1.20|||0.05
73802704|NCT03982511|147155083|SUPERIORITY||Mean Difference (Net)|-17.23|STANDARD_ERROR_OF_MEAN|6.93||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PCDI scores from T2 to T1.|effect size: -1.21|||0.02
73895133|NCT00130247|147323271|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.43||||||95.0|0.94|12.5|||Regression, Linear|||Rate of relapse at 1 year. All patients adherent with treatment and remaining in follow-up at 1 year were included in the calculation of the relapse incidence rate.||12.5|0.94|
73895134|NCT00130247|147323271|SUPERIORITY_OR_OTHER||Incident rate ratio|4.52||||||95.0|1.29|15.9|||Regression, Linear|||Rate of relapse at 2 years. All patients adherent with treatment and remaining in follow-up at 2 years were included in the calculation of the relapse incidence rate.||15.9|1.29|
73895135|NCT00130247|147323277|NON_INFERIORITY_OR_EQUIVALENCE|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.054||||||95.0|0.01|0.1|||Regression, Cox||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.|||0.10|0.01|
73895136|NCT03844945|147323279|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73895137|NCT04473235|147323280|SUPERIORITY||Mean Difference (Final Values)|-0.799|STANDARD_ERROR_OF_MEAN|1.3||0.531|TWO_SIDED||||||t-test, 2 sided|||||||0.531
73895138|NCT04473235|147323281|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.627|TWO_SIDED||||||t-test, 2 sided|||Difference in the connectivity between the left hippocampus and left prefrontal cortex.||||0.627
73895139|NCT04473235|147323281|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.12|TWO_SIDED||||||t-test, 2 sided|||Difference in the connectivity between the right hippocampus and right prefrontal cortex.||||0.120
73802705|NCT03982511|147155083|SUPERIORITY||Mean Difference (Net)|-19.43|STANDARD_ERROR_OF_MEAN|6.4||0.008|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PCDI scores from T3 to T1|effect size: -1.57|||0.008
73895140|NCT00395343|147323347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.7|-0.42|||ANCOVA|Model terms: treatment; baseline; metformin stratum (on vs. not on metformin); insulin stratum (pre-mixed vs. intermediate or long-acting)||||-0.42|-0.70|<0.001
73895141|NCT00395343|147323348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|||<|0.001||95.0|-23.4|-6.5|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum||||-6.5|-23.4|<0.001
73895142|NCT00395343|147323349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.1|||<|0.001||95.0|-47.1|-25.1|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum||||-25.1|-47.1|<0.001
73895143|NCT00395343|147323350|SUPERIORITY_OR_OTHER||Geometric Mean Difference|36.5||||0.01||95.0|8.9|64.7|||ANCOVA|Model terms: treatment; log-scaled baseline value; metformin stratum; insulin stratum||||64.7|8.9|0.01
73895144|NCT00395343|147323351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.6|||<|0.001||95.0|1.89|6.85||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum||||6.85|1.89|<0.001
73895145|NCT00395343|147323352|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.584||95.0|0.45|4.18||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<6.5% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|||4.18|0.45|0.584
73895146|NCT00395343|147323353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.72|-0.4|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum, treatment by insulin stratum interaction||||-0.40|-0.72|<0.001
73895147|NCT00966875|147323388|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||A log transformed dose was used in the model.|Regression, Logistic|||||||0.031
73895148|NCT00966875|147323389|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Fisher Exact|||||||0.033
73895149|NCT00966875|147323389|SUPERIORITY_OR_OTHER|||||||0.047|||||||Fisher Exact|||||||0.047
73895150|NCT00966875|147323393|SUPERIORITY_OR_OTHER|||||||0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.013
73895151|NCT00966875|147323393|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.004
73895152|NCT00966875|147323393|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895153|NCT00966875|147323393|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895154|NCT00966875|147323393|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895155|NCT00966875|147323393|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895156|NCT00966875|147323393|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895157|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.227
73802706|NCT03982511|147155084|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.36||0.5|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for pressure to eat scores from T2 to T1|effect size: -0.34|||0.50
73895158|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.306
73895159|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.001
73895160|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.070
73895161|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.058
73895162|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.033
73895163|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.047
73802707|NCT03982511|147155084|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.37||0.98|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for pressure to eat scores from T3 to T1|effect size: -0.01|||0.98
73802708|NCT03982511|147155085|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.32||0.17|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive feeding scores from T2 to T1|effect size: -0.70|||0.17
73802709|NCT03982511|147155085|SUPERIORITY||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.35||0.34|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive feeding scores from T3 to T1|effect size: -0.51|||0.34
73802710|NCT03982511|147155086|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.23||0.91|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for emotional feeding scores from T2 to T1|effect size: -0.06|||0.91
73802711|NCT03982511|147155086|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.22||0.45|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for emotional feeding scores from T3 to T1|effect size: -0.40|||0.45
73802712|NCT03982511|147155087|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for instrumental feeding scores from T2 to T1.|effect size: -1.12|||0.03
73802713|NCT03982511|147155087|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for instrumental feeding scores from T3 to T1|effect size: -1.25|||0.03
73802714|NCT03982511|147155088|SUPERIORITY||Mean Difference (Net)|2.23|STANDARD_ERROR_OF_MEAN|1.06||0.05|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for active mediation from T2 to T1|effect size: 1.02|||0.05
73802715|NCT03982511|147155088|SUPERIORITY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.47||0.11|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for active mediation scores from T3 to T1|effect size: 0.88|||0.11
73802716|NCT03982511|147155089|SUPERIORITY||Mean Difference (Net)|3.64|STANDARD_ERROR_OF_MEAN|1.0||0.002|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive mediation scores from T2 to T1|effect size: 1.77|||0.002
73802717|NCT03982511|147155089|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.08||0.24|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive mediation scores from T3 to T1|effect size: 0.63|||0.24
73802718|NCT03982511|147155090|SUPERIORITY||Mean Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|1.05||0.53|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for social coviewing from T2 to T1|effect size: 0.31|||0.53
73802719|NCT03982511|147155090|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|1.1||0.77|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for social coviewing from T3 to T1|effect size: 0.15|||0.77
73802720|NCT03982511|147155091|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.23||0.91|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in the home from T2 to T1|effect size: 0.04|||0.91
73802721|NCT03982511|147155091|SUPERIORITY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|1.36||0.64|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in the home from T3 to T1|effect size: 0.17|||0.64
73802722|NCT03982511|147155091|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.34||0.31|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in child bedroom from T2 to T1|effect size: -0.36|||0.31
73802723|NCT03982511|147155091|SUPERIORITY||Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|0.39||0.04|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in child bedroom from T3 to T1|effect size: -0.85|||0.04
73802724|NCT03982511|147155092|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided|ANOVA|repeated measures||Difference on difference for TV on during mealtime from T2 to T1|effect size: -1.25|||0.03
73895164|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.191|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.191
73802725|NCT03982511|147155092|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.1|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided|ANOVA|repeated measures||Difference on difference for TV on during mealtime from T3 to T1|effect size: -1.08|||0.10
73802726|NCT03982511|147155092|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.41|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mobile device present during mealtime from T2 to T1|effect size: -0.44|||0.41
73802727|NCT03982511|147155092|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.22||0.21|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mobile device present during mealtime from T3 to T1|effect size: -0.80|||0.21
73802728|NCT03982511|147155092|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for other media present during mealtime from T2 to T1|effect size: -1.29|||0.02
73802729|NCT03982511|147155092|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.2|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for other media present during mealtime from T3 to T1|effect size: -0.82|||0.20
73802730|NCT03982511|147155093|SUPERIORITY||Mean Difference (Net)|0.42|STANDARD_ERROR_OF_MEAN|0.14||0.009|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime task accomplishment scores from T2 to T1|effect size: 1.55|||0.009
73802731|NCT03982511|147155093|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.15||0.84|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime task accomplishment scores from T3 to T1|effect size: -0.13|||0.84
73802732|NCT03982511|147155093|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.2||0.24|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime behavior control scores from T2 to T1|effect size: 0.63|||0.24
73802733|NCT03982511|147155093|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.15||0.84|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime behavior control scores from T3 to T1.|effect size: -0.13|||0.84
73802734|NCT03982511|147155094|SUPERIORITY||Mean Difference (Net)|-9.5|STANDARD_ERROR_OF_MEAN|2.17||0|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for ECBI intensity t-scores from T2 to T1|effect size: -1.50|||0.00
73802735|NCT03982511|147155094|SUPERIORITY||Mean Difference (Net)|-7.63|STANDARD_ERROR_OF_MEAN|2.48||0.01|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for ECBI intensity t-scores from T3 to T1|effect size: -1.12|||0.01
73802736|NCT03982511|147155095|SUPERIORITY||Mean Difference (Net)|-6.93|STANDARD_ERROR_OF_MEAN|2.63||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for internalizing symptoms from T2 to T1|effect size: -0.93|||0.02
73802737|NCT03982511|147155095|SUPERIORITY||Mean Difference (Net)|-6.58|STANDARD_ERROR_OF_MEAN|3.56||0.08|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for internalizing symptoms from T3 to T1|effect size: -0.68|||0.08
73802738|NCT03982511|147155095|SUPERIORITY||Mean Difference (Net)|-6.47|STANDARD_ERROR_OF_MEAN|6.92||0.36|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for adaptive skills from T2 to T1|effect size: -0.33|||0.36
73802739|NCT03982511|147155095|SUPERIORITY||Mean Difference (Net)|-3.57|STANDARD_ERROR_OF_MEAN|8.83||0.69|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for adaptive skills from T3 to T1|effect size: -0.15|||0.69
73802740|NCT03982511|147155096|SUPERIORITY||Mean Difference (Net)|35.78|STANDARD_ERROR_OF_MEAN|7.21||0|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PSICA intensity scores from T2 to T1 (higher scores indicate better outcomes).|effect size: 1.70|||0.000
73802741|NCT03982511|147155096|SUPERIORITY||Mean Difference (Net)|21.78|STANDARD_ERROR_OF_MEAN|7.64||0.01|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PSICA intensity scores from T3 to T1|effect size: 1.04|||0.01
73802742|NCT03982511|147155097|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.73|TWO_SIDED|||||Given this is a pilot RCT, primary aim is to estimate effect size for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures|Effect size: 0.17|Difference on difference from T2 to T1 for BMI z-score||||.73
73895165|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.019
73895166|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.013
73895167|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.017
73895168|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.026
73895169|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.039
73895170|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.102
73895171|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.388|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.388
73895172|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.033
73802743|NCT03982511|147155097|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.98|TWO_SIDED|||||Given this is a pilot RCT, primary aim is to estimate effect size for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures||Difference on difference for BMI z-scores from T3 to T1.|Effect size: -0.01|||.98
73802744|NCT00568451|147155100|SUPERIORITY_OR_OTHER||Median|12.5|||||ONE_SIDED|95.0|4.5||||Kaplan-Meier||||||4.5|
73802745|NCT02535026|147155113|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||ER status association with age groups||||0.280
73802746|NCT02535026|147155114|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||ER status association with nuclear grade.||||<0.001
73802747|NCT02535026|147155115|SUPERIORITY_OR_OTHER||||||=|0.03|||||||Chi-squared|||ER status association with lymphovascular invasion.||||=0.03
73802748|NCT02535026|147155116|SUPERIORITY_OR_OTHER||||||=|0.004|||||||Chi-squared|||PR status association with age groups||||=0.004
73802749|NCT02535026|147155117|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||PR status association with nuclear grade.||||<0.001
73895173|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.039
73895174|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.199
73895175|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.039
73895176|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.696|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.696
73895177|NCT00966875|147323395|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.112
73802750|NCT02535026|147155118|SUPERIORITY_OR_OTHER||||||=|0.025|||||||ANOVA|||PR status association with lymphovascular invasion.||||=0.025
73802751|NCT02535026|147155119|SUPERIORITY_OR_OTHER||||||=|0.056|||||||ANOVA|||HER2 status association with age groups.||||=0.056
73802752|NCT02535026|147155120|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||HER2 status association with nuclear grade.||||<0.001
73802753|NCT02535026|147155121|SUPERIORITY_OR_OTHER||||||=|0.129|||||||Chi-squared|||||||=0.129
73802754|NCT02535026|147155122|SUPERIORITY_OR_OTHER||||||=|0.003|||||||ANOVA|||Breast cancer phenotypes association with age groups.||||=0.003
73895178|NCT00966875|147323397|SUPERIORITY_OR_OTHER|||||||0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.017
73895179|NCT00966875|147323397|SUPERIORITY_OR_OTHER|||||||0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.042
73895180|NCT00966875|147323397|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.004
73895181|NCT00966875|147323397|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895182|NCT00966875|147323397|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895183|NCT00966875|147323397|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.008
73895184|NCT00966875|147323397|SUPERIORITY_OR_OTHER|||||||0.007||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.007
73895185|NCT00966875|147323399|SUPERIORITY_OR_OTHER|||||||0.093||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.093
73895186|NCT00966875|147323399|SUPERIORITY_OR_OTHER|||||||0.023||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.023
73895187|NCT00966875|147323399|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.006
73895188|NCT00966875|147323399|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.001
73895189|NCT00966875|147323399|SUPERIORITY_OR_OTHER|||||||0.028||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.028
73895190|NCT00966875|147323399|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895191|NCT00966875|147323399|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895192|NCT00966875|147323401|SUPERIORITY_OR_OTHER|||||||0.247||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.247
73895193|NCT00966875|147323401|SUPERIORITY_OR_OTHER|||||||0.315||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.315
73895194|NCT00966875|147323401|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.006
73895195|NCT00966875|147323401|SUPERIORITY_OR_OTHER|||||||0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.042
73895196|NCT00966875|147323401|SUPERIORITY_OR_OTHER|||||||0.055||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.055
73895197|NCT00966875|147323401|SUPERIORITY_OR_OTHER|||||||0.365||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.365
73895198|NCT00966875|147323401|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.005
73895199|NCT00966875|147323403|SUPERIORITY_OR_OTHER|||||||0.778||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.778
73802755|NCT02535026|147155123|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Breast cancer phenotypes association with nuclear grades.||||<0.001
73802756|NCT02535026|147155124|SUPERIORITY_OR_OTHER||||||=|0.001|||||||ANOVA|||phenotypes of breast cancer association with lymphovascular invasion.||||=0.001
73802757|NCT02535026|147155125|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with ER status.||||<0.001
73802758|NCT02535026|147155126|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Phenotypes of breast cancer association with PR status.||||<0.001
73802759|NCT02535026|147155127|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with HER2 status.||||<0.001
73802760|NCT00925704|147155146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.171
73802761|NCT00925704|147155146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.024
73802762|NCT00925704|147155147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.313||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.313
73802763|NCT00925704|147155147|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||< 0.001
73802764|NCT00925704|147155148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.||||0.039
73802765|NCT00925704|147155148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||95.0|||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.||||0.305
73802766|NCT00216125|147155149|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.883|TWO_SIDED|95.0|||||Log Rank|||||||0.883
73802767|NCT03207815|147155154|SUPERIORITY||Difference in Treatment Failure Rate|-30.1||||0.0064|TWO_SIDED|95.0|-56.2|-4.1||P-value was estimated from the Cochran-Mantel-Haenszel (CMH) test, adjusted for the stratification factors.|Cochran-Mantel-Haenszel|Participants with missing values on treatment failure status were analyzed as treatment failures using a nonresponder imputation (NRI) method.||||-4.1|-56.2|0.0064
73802768|NCT03207815|147155155|SUPERIORITY||Stratified Hazard Ratio|0.309||||0.0014|TWO_SIDED|95.0|0.144|0.663||P-value was derived from the log rank test stratified by the stratification factors.|Stratified Log-Rank Test||Stratified hazard ratio (95% confidence interval \[CI\]) were derived from the Cox model stratified by the stratification factors.|||0.663|0.144|0.0014
73802769|NCT03207815|147155156|SUPERIORITY||Least Squares Mean Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.355|TWO_SIDED|95.0|-0.4|0.2||P-value was estimated using a repeated measure Analysis of Covariance (ANCOVA) model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in Least Squares (LS)-means (95% CI) were obtained from the repeated measure ANCOVA model.|||0.2|-0.4|0.3550
73802770|NCT03207815|147155157|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0145|TWO_SIDED|95.0|-0.8|-0.1||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.1|-0.8|0.0145
73802771|NCT03207815|147155158|SUPERIORITY||LS Mean Treatment Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.025||0.0389|TWO_SIDED|95.0|-0.1|0.0||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.00|-0.10|0.0389
73802772|NCT03207815|147155159|SUPERIORITY||LS Mean Treatment Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.034|TWO_SIDED|95.0|-0.05|0.0||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, OCT machine, and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.00|-0.05|0.0340
73802773|NCT03207815|147155160|SUPERIORITY||Stratified Hazard Ratio|1.193||||0.5893|TWO_SIDED|95.0|0.625|2.277||P-value was derived from the log rank test stratified by the stratification factors.|Stratified Log-Rank Test||Stratified hazard ratio (95% CI) were derived from the Cox model stratified by the stratification factors.|||2.277|0.625|0.5893
73802774|NCT01671007|147155163|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.64|1.08|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.08|0.64|
73802775|NCT01671007|147155164|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.7|1.27|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.27|0.70|
73802776|NCT01671007|147155165|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.43|1.06|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.06|0.43|
73802777|NCT01671007|147155166|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.43|1.09|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.09|0.43|
73802778|NCT01671007|147155170|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.38|0.88|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.||0.88|0.38|
73802779|NCT01671007|147155173|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.49|1.84|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.||1.84|0.49|
73802780|NCT01671007|147155174|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.01|0.60|
73802781|NCT00391768|147155181|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Spearman Correlation|||||||0.07
73802782|NCT00391768|147155181|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Spearman Correlation|||||||0.60
73802783|NCT00391768|147155181|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Spearman Correlation|||||||0.27
73802784|NCT00391768|147155181|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Spearman Correlation|||||||0.77
73802785|NCT00391768|147155181|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Spearman Correlation|||||||0.47
73802786|NCT00391768|147155181|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Spearman Correlation|||||||0.96
73802787|NCT00406367|147155183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5||No type I-error adjustment was necessary in this study.|ANCOVA|Indepent variables in the model were treatment, baseline JRS-Severity score, gender, age, dose, and pooled center.||The null hypothesis in the analysis of covariance (ANCOVA) model was the absence of difference in the change from baseline in the JRS severity subscore between incobotulinumtoxinA (Xeomin) and placebo. The ANCOVA model was performed 2-sided (type-I error=5 percent) and change from baseline in the JRS Severity subscore assessed by a blinded Independent Rater as dependent variable. The independent variables were treatment, baseline JRS Severity subscore, gender, age, dose group, and pooled center.||-0.5|-1.4|<0.001
73802788|NCT03187301|147155203|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% confidence intervals (CIs) for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|0.5|7.4||||||15 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The mixed model for repeated measurements (MMRM) included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||7.4|0.5|
73802789|NCT03187301|147155203|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|-0.5|6.5||||||30 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||6.5|-0.5|
73802790|NCT03187301|147155203|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|0.2|7.2||||||45 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||7.2|0.2|
73802791|NCT03187301|147155203|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|2.7|9.7||||||60 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||9.7|2.7|
73895200|NCT00966875|147323403|SUPERIORITY_OR_OTHER|||||||0.865||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.865
73802792|NCT03187301|147155203|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|1.3|8.3||||||2 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||8.3|1.3|
73802793|NCT03187301|147155203|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|-1.7|5.3||||||3 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||5.3|-1.7|
73802794|NCT03187301|147155203|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Sqaure (LS) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.12||||90.0|-4.2|2.8||||||4 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||2.8|-4.2|
73802795|NCT03187301|147155208|NON_INFERIORITY|15 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|0.3|8.6||||||||8.6|0.3|
73802796|NCT03187301|147155208|NON_INFERIORITY|30 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-1.6|6.7||||||||6.7|-1.6|
73802797|NCT03187301|147155208|NON_INFERIORITY|45 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-0.9|7.4||||||||7.4|-0.9|
73802798|NCT03187301|147155208|NON_INFERIORITY|60 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-0.9|7.5||||||||7.5|-0.9|
73802799|NCT03187301|147155208|NON_INFERIORITY|2 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|0.8|9.2||||||||9.2|0.8|
73802800|NCT03187301|147155208|NON_INFERIORITY|3 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|90.0|0.4|8.8||||||||8.8|0.4|
73802801|NCT03187301|147155208|NON_INFERIORITY|4 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Differeence|2.6|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|90.0|-1.6|6.9||||||||6.9|-1.6|
73802802|NCT03187301|147155212|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|10.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|5.3|14.8||||||60 mins post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||14.8|5.3|
73802803|NCT03187301|147155212|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|7.5|17.1||||||2 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||17.1|7.5|
73895201|NCT00966875|147323403|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.030
73802804|NCT03187301|147155212|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|10.9|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|6.1|15.7||||||3 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||15.7|6.1|
73802805|NCT03187301|147155212|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|4.2|13.8||||||4 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||13.8|4.2|
73802806|NCT02158585|147155219|SUPERIORITY||Mean Difference (Final Values)|8.93||||0.5618|TWO_SIDED|95.0|-3.49|21.35|||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference between groups in average total number of vertigo attacks||21.35|-3.49|0.5618
73802807|NCT02158585|147155220|SUPERIORITY|||||||0.03429|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference between average total number of vertigo attacks in pre-treatment and treatment||||0.03429
73802808|NCT02158585|147155221|SUPERIORITY||Mean Difference (Net)|4.57||||0.0092|TWO_SIDED|95.0|0.85|8.29|||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference in total average number of vertigo attacks during 3 week time periods||8.29|0.85|0.0092
73802809|NCT02158585|147155224|SUPERIORITY||Median Difference (Final Values)|11.14||||0.0385|TWO_SIDED|95.0|-15.64|37.92|||Wilcoxon (Mann-Whitney)|||||37.92|-15.64|0.0385
73802810|NCT02375971|147155243|SUPERIORITY|The primary efficacy variable was treatment success, defined as the absence of active ROP and absence of unfavorable structural outcomes in both eyes 24 weeks after starting study treatment.|Odds Ratio (OR)|2.19||||0.0254|TWO_SIDED|95.0|0.9932|4.8235|||Cochran-Mantel-Haenszel|||||4.8235|0.9932|0.0254
73802811|NCT02667704|147155255|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|98.85|STANDARD_DEVIATION|11.4|||TWO_SIDED|90.0|91.32|107.01|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||107.010|91.320|
73802812|NCT02667704|147155256|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|103.36|STANDARD_DEVIATION|26.5|||TWO_SIDED|90.0|86.134|124.025|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||124.025|86.134|
73802813|NCT02667704|147155257|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|101.98|STANDARD_DEVIATION|10.3|||TWO_SIDED|90.0|94.909|109.57|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||109.570|94.909|
73802814|NCT00832455|147155258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||||||<0.001
73802815|NCT00832455|147155258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||||||<0.001
73895202|NCT00966875|147323403|SUPERIORITY_OR_OTHER|||||||0.331||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.331
73895203|NCT00966875|147323403|SUPERIORITY_OR_OTHER|||||||0.039||||||P-value is for Week 12..|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.039
73802816|NCT00832455|147155260|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 12.||||||<0.001
73802817|NCT00832455|147155260|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 8.||||||<0.001
73802818|NCT00832455|147155261|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of patient satisfaction at week 0 compared to week 12.||||||<0.001
73802819|NCT00832455|147155262|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|Change in PACQLQ score between Week 12 and baseline is statistically different than zero||||||<0.001
73802820|NCT01514292|147155302|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Fisher Exact|||"Hence, the hypothesis is established as:~Ho: pi \< 71.5% Ha: pi \>71.5% Thus, the objective is to conclude that the proportion of G4 Sensor-YSI points in the present study meeting the 20 mg/dL/20% criterion is no worse than the existing FDA-approved SEVEN PLUS System. The null hypothesis will be rejected if pi observed in this study is greater than 71.5%, the G4 System performance is no worse than the historical performance of the existing FDA approved CGM system will be concluded."||||0.0001
73895204|NCT00966875|147323403|SUPERIORITY_OR_OTHER|||||||0.292||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.292
73895205|NCT00966875|147323403|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.003
73895206|NCT00966875|147323405|SUPERIORITY_OR_OTHER|||||||0.09||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.090
73895207|NCT00966875|147323405|SUPERIORITY_OR_OTHER|||||||0.131||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.131
73895208|NCT00966875|147323405|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.008
73895209|NCT00966875|147323405|SUPERIORITY_OR_OTHER|||||||0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.013
73895210|NCT00966875|147323405|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.010
73802821|NCT01262872|147155317|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|-7.9|||||TWO_SIDED|95.0|-36.3|14.6||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||14.6|-36.3|
73802822|NCT01262872|147155317|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|6.4|||||TWO_SIDED|95.0|-17.8|25.7||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.7|-17.8|
73802823|NCT01262872|147155317|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|2.5|||||TWO_SIDED|95.0|-22.6|22.5||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||22.5|-22.6|
73802824|NCT01262872|147155317|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|4.5|||||TWO_SIDED|95.0|-21.4|25.0||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.0|-21.4|
73802825|NCT01262872|147155317|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|5.3|||||TWO_SIDED|95.0|-19.2|24.8||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||24.8|-19.2|
73802826|NCT01262872|147155317|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|0.6|||||TWO_SIDED|95.0|-24.9|20.9||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||20.9|-24.9|
73802827|NCT01262872|147155318|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.6|||||TWO_SIDED|95.0|-18.2|26.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 1M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||26.2|-18.2|
73895211|NCT00966875|147323405|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895212|NCT00966875|147323405|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895213|NCT00966875|147323407|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895214|NCT00966875|147323407|SUPERIORITY_OR_OTHER|||||||0.012||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.012
73895215|NCT00966875|147323407|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895216|NCT00966875|147323407|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895217|NCT00966875|147323407|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895218|NCT00966875|147323407|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
73895219|NCT00966875|147323407|SUPERIORITY_OR_OTHER|||||||0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.001
73895220|NCT00966875|147323409|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.013
73895221|NCT00966875|147323409|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.076
73802828|NCT01262872|147155318|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.3|||||TWO_SIDED|95.0|-18.0|25.7||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 5M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.7|-18.0|
73802829|NCT01262872|147155318|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|-3.5|||||TWO_SIDED|95.0|-29.3|17.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 3M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, three months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||17.2|-29.3|
73802830|NCT00365794|147155404|OTHER|||||||0.77|||||||t-test, 2 sided|||Total body mass||||0.77
73802831|NCT00365794|147155404|OTHER|||||||0.003|||||||t-test, 2 sided|||Total fat mass||||0.003
73802832|NCT00365794|147155404|OTHER|||||||0.0007|||||||t-test, 2 sided|||Statistical analysis is for change in trunk fat mass after 20 weeks of testosterone gel.||||0.0007
73802833|NCT00365794|147155404|OTHER|||||||0.01|||||||t-test, 2 sided|||Statistical analysis is for change in extremity fat mass after 20 weeks of testosterone gel.||||0.01
73802834|NCT00365794|147155405|OTHER|||||||0.12||||||No adjustment in p for multiple comparisons.|t-test, 2 sided|||||||0.12
73802835|NCT00365794|147155406|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
73895222|NCT00966875|147323409|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.002
73802836|NCT00365794|147155407|OTHER|||||||0.0002||||||No adjustment for multiple comparisons.|t-test, 2 sided|||||||0.0002
73802837|NCT00365794|147155408|OTHER|||||||0.04|||||||t-test, 2 sided|||Statistical analysis for change in whole body insulin sensitivity after treatment with testosterone gel for 20 weeks.||||0.04
73802838|NCT00365794|147155408|OTHER|||||||0.59|||||||t-test, 2 sided|||Statistical analysis for change in hepatic glucose output (measure of central insulin sensitivity) after treatment with testosterone gel for 20 weeks||||0.59
73802839|NCT00365794|147155408|OTHER|||||||0.03|||||||t-test, 2 sided|||Statistical analysis for change in rate of peripheral glucose disposal (test of peripheral insulin sensitivity) after treatment with testosterone gel for 20 weeks||||0.03
73802840|NCT00365794|147155409|OTHER|||||||0.0006|||||||t-test, 2 sided|||Change in DEXA extremity (appendicular) lean tissue, a measure of extremity muscle mass after 20 weeks ot treatent with testosterone gel.||||0.0006
73802841|NCT00365794|147155410|OTHER|Test for fasting triglycerides||||||0.02|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel.||||0.02
73802842|NCT00365794|147155410|OTHER|Test for total cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||0.004
73802843|NCT00365794|147155410|OTHER|Test for LDL cholesterol||||||0.02|||||||t-test, 2 sided|||nts A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||.02
73802844|NCT00365794|147155410|OTHER|Test for HDL cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||0.004
73802845|NCT00365794|147155411|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
73802846|NCT00365794|147155412|OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
73802847|NCT00365794|147155413|OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
73802848|NCT00745901|147155414|SUPERIORITY_OR_OTHER|||||||0.9698||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9698
73802849|NCT00745901|147155415|SUPERIORITY_OR_OTHER|||||||0.0715||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0715
73802850|NCT00745901|147155416|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0050
73802851|NCT00745901|147155417|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0006
73802852|NCT00745901|147155418|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0031
73802853|NCT00745901|147155419|SUPERIORITY_OR_OTHER|||||||0.0013||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0013
73802854|NCT00745901|147155420|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73802855|NCT00745901|147155421|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73802856|NCT00745901|147155422|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73802857|NCT00745901|147155423|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73802858|NCT00745901|147155424|SUPERIORITY_OR_OTHER|||||||0.0033||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0033
73802859|NCT00745901|147155425|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0060
73802860|NCT00745901|147155426|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73802861|NCT00745901|147155427|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73802862|NCT00745901|147155428|SUPERIORITY_OR_OTHER|||||||0.912||95.0|||||Fisher Exact|||||||0.912
73802863|NCT00745901|147155429|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
73802864|NCT00745901|147155430|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||||||0.002
73802865|NCT00745901|147155431|SUPERIORITY_OR_OTHER|||||||0.816||95.0|||||Fisher Exact|||||||0.816
73895223|NCT00966875|147323409|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||<0.001
73895224|NCT00966875|147323409|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for Week 12.|Fisher Exact|||||||0.002
73895225|NCT00966875|147323409|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.006
73895226|NCT00966875|147323409|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12.|Fisher Exact|||||||0.001
73802866|NCT00745901|147155432|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Fisher Exact|||||||0.012
73802867|NCT00745901|147155433|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
73802868|NCT01804946|147155436|NON_INFERIORITY_OR_EQUIVALENCE|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0||||0.05|ONE_SIDED|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed||||0.05
73802869|NCT01804946|147155437|NON_INFERIORITY_OR_EQUIVALENCE|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0|||<|0.05|ONE_SIDED|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed||||<0.05
73802870|NCT01804946|147155438|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant margin was assumed to be 0.2 of Oseltamivir effect|Mean Difference (Final Values)|0.0|||<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
73802871|NCT01804946|147155439|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant margin was assumed to be 0.2°C|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means.||PP set was analyzed||||<0.05
73802872|NCT01804946|147155440|NON_INFERIORITY_OR_EQUIVALENCE|The margin of no clinical importance was assumed to be 0.5 point or less to assess any symptom based on 4 point scale.|Mean Difference (Final Values)|0.0|||<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
73802873|NCT01804946|147155441|NON_INFERIORITY_OR_EQUIVALENCE|To compare the number of antipyretic intake the margin of no clinical importance was assumed to be 0.2|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
73802874|NCT01804946|147155442|NON_INFERIORITY_OR_EQUIVALENCE|To compare the quality of life total score the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|2.2|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|The changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed||||<0.05
73802875|NCT01804946|147155443|NON_INFERIORITY_OR_EQUIVALENCE|To compare the patient subjective health status assessment the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|18.2|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed||||<0.05
73802876|NCT01804946|147155444|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant difference (margin) between two percentages was assumed to be 20% or more of the effect of Oseltamivir|Risk Difference (RD)|0.0|||<|0.05|ONE_SIDED|95.0|||||The Wald method of Z statistics calcul|The Wald method of Z statistics calculation was performed including computation a confidence interval for a difference between proportions||PP set was analyzed||||<0.05
73802877|NCT00722137|147155449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.5|0.79|||Log Rank|Based on Log rank test stratified with International Prognostic Index (IPI) risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.79|0.50|<0.001
73802878|NCT00722137|147155450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.74|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.74|0.45|<0.001
73802879|NCT00722137|147155452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.65|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.65|0.38|<0.001
73802880|NCT00722137|147155453|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||=|0.001|TWO_SIDED|95.0|0.38|0.65|||Log Rank|||||0.65|0.38|=0.001
73802881|NCT00722137|147155454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.428||||0.275|TWO_SIDED|95.0|0.749|2.722|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.|||2.722|0.749|0.275
73802882|NCT00722137|147155455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.688|||<|0.007|TWO_SIDED|95.0|1.148|2.481|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.|||2.481|1.148|<0.007
73802883|NCT00722137|147155456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.173|TWO_SIDED|95.0|0.59|1.1|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||1.10|0.59|0.173
73895227|NCT00966875|147323411|SUPERIORITY_OR_OTHER|||||||0.307||||||P-value is for Week 12.|ANCOVA|||||||0.307
73895228|NCT00966875|147323411|SUPERIORITY_OR_OTHER|||||||0.104||||||P-value is for Week 12.|ANCOVA|||||||0.104
73895229|NCT00966875|147323411|SUPERIORITY_OR_OTHER|||||||0.139||||||P-value is for Week 12.|ANCOVA|||||||0.139
73895230|NCT00966875|147323411|SUPERIORITY_OR_OTHER|||||||0.056||||||P-value is for Week 12.|ANCOVA|||||||0.056
73802884|NCT01120184|147155504|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target hazard ratio (HR) equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was less than (\<) 1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \<1.00.|Hazard Ratio (HR)|0.91||||0.3125|TWO_SIDED|97.5|0.73|1.13||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.13|0.73|0.3125
73802885|NCT01120184|147155504|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was \<1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \<1.00.|Hazard Ratio (HR)|0.87||||0.1407|TWO_SIDED|97.5|0.69|1.08||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.08|0.69|0.1407
73802886|NCT01120184|147155504|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Hazard Ratio (HR)|0.91||||0.3075|TWO_SIDED|97.5|0.73|1.13||Test and p-value apply for superiority test. Primary endpoint did not meet superiority of PFS for trastuzumab emtansine + pertuzumab versus trastuzumab + taxane (two-sided significance level 2.5%); thus, tests and p-value are considered descriptive.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.13|0.73|0.3075
73802887|NCT01120184|147155506|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.6568|TWO_SIDED|97.5|0.73|1.2|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.20|0.73|0.6568
73802888|NCT01120184|147155506|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.5691|TWO_SIDED|97.5|0.67|1.11|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.11|0.67|0.5691
73802889|NCT01120184|147155508|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|97.5|0.69|1.04|||||Direction of comparison: Trastuzumab Emtasine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.04|0.69|
73802890|NCT01120184|147155508|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|97.5|0.63|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.95|0.63|
73802891|NCT01120184|147155510|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|97.5|0.66|0.97|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.97|0.66|
73802892|NCT01120184|147155510|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|97.5|0.65|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.95|0.65|
73802893|NCT01120184|147155520|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-8.2|||||TWO_SIDED|95.0|-15.9|-0.5|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||-0.5|-15.9|
73802894|NCT01120184|147155520|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-3.7|||||TWO_SIDED|95.0|-11.4|3.9|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|||3.9|-11.4|
73802895|NCT01120184|147155520|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|4.5|||||TWO_SIDED|95.0|-3.3|12.2|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|||12.2|-3.3|
73802896|NCT01120184|147155521|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-4.6|||||TWO_SIDED|95.0|-12.1|2.8|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||2.8|-12.1|
73802897|NCT01120184|147155521|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-1.8|||||TWO_SIDED|95.0|-9.2|5.7|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|||5.7|-9.2|
73802898|NCT01120184|147155521|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|2.9|||||TWO_SIDED|95.0|-4.5|10.3|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|||10.3|-4.5|
73802899|NCT01120184|147155522|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|97.5|0.43|0.84|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.84|0.43|
73802900|NCT01120184|147155522|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|97.5|0.45|0.85|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.85|0.45|
73802901|NCT01120184|147155524|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|-32.2|||||TWO_SIDED|95.0|-40.0|-24.0|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||-24|-40|
73802902|NCT01120184|147155524|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|-24.2|||||TWO_SIDED|95.0|-32.0|-16.0|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||-16|-32|
73802903|NCT01120184|147155524|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|8.0|||||TWO_SIDED|95.0|-2.3|18.4|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||18.4|-2.3|
73802904|NCT01120184|147155528|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.57|0.86|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.86|0.57|
73895231|NCT00966875|147323411|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|||||||0.048
73802905|NCT01120184|147155528|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.55|0.84|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.84|0.55|
73802906|NCT01120184|147155532|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.4|1.15|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.15|0.40|
73802907|NCT01120184|147155533|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.66|||||TWO_SIDED|95.0|0.41|1.07|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.07|0.41|
73802908|NCT01120184|147155535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|97.5|0.65|1.25|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.25|0.65|
73802909|NCT01120184|147155537|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|97.5|0.74|1.34|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.34|0.74|
73802910|NCT01894841|147155560|SUPERIORITY||Partial eta squared|0.03||||0.13|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.13
73802911|NCT01894841|147155561|SUPERIORITY||Partial eta squared|0.01||||0.79|TWO_SIDED||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).||||||.79
73802912|NCT01894841|147155562|SUPERIORITY||Partial eta squared|0.02||||0.49|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.49
73802913|NCT01894841|147155563|SUPERIORITY||Partial eta-squared|0.003||||0.96|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.96
73802914|NCT01894841|147155564|SUPERIORITY||Partial eta squared|0.01||||0.62|TWO_SIDED||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).||||||.62
73802915|NCT00529087|147155598|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|24.4|||<|0.001||95.0|17.3|31.4|||Chi-squared|||||31.4|17.3|<0.001
73802916|NCT00529087|147155599|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.5|||<|0.001||95.0|15.1|24.0|||t-test, 2 sided|||||24.0|15.1|<0.001
73802917|NCT00529087|147155599|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|20.9|||<|0.001||95.0|16.1|25.7|||t-test, 2 sided|||||25.7|16.1|<0.001
73802918|NCT00529087|147155600|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Log Rank|Log-rank test for comparisons of survival distributions||||||<0.001
73802919|NCT00529087|147155601|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.6|||<|0.001||95.0|1.1|2.1|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate||||2.1|1.1|<0.001
73895232|NCT00966875|147323411|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value is for Week 12.|ANCOVA|||||||0.160
73895233|NCT00966875|147323411|SUPERIORITY_OR_OTHER|||||||0.029||||||P-value is for Week 12.|ANCOVA|||||||0.029
73895234|NCT00966875|147323413|SUPERIORITY_OR_OTHER|||||||0.272||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.272
73895235|NCT00966875|147323413|SUPERIORITY_OR_OTHER|||||||0.962||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.962
73895236|NCT00966875|147323413|SUPERIORITY_OR_OTHER|||||||0.236||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.236
73895237|NCT00966875|147323413|SUPERIORITY_OR_OTHER|||||||0.316||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.316
73895238|NCT00966875|147323413|SUPERIORITY_OR_OTHER|||||||0.138||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.138
73895239|NCT00966875|147323413|SUPERIORITY_OR_OTHER|||||||0.975||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.975
73895240|NCT00966875|147323413|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.079
73895241|NCT00966875|147323415|SUPERIORITY_OR_OTHER|||||||0.982||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.982
73895242|NCT00966875|147323415|SUPERIORITY_OR_OTHER|||||||0.276||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.276
73895243|NCT00966875|147323415|SUPERIORITY_OR_OTHER|||||||0.05||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.050
73895244|NCT00966875|147323415|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.010
73895245|NCT00966875|147323415|SUPERIORITY_OR_OTHER|||||||0.046||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.046
73802920|NCT00529087|147155601|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.7||||0.011||95.0|0.2|1.2|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate||||1.2|0.2|0.011
73802921|NCT00529087|147155603|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|20.4|||<|0.001||95.0|9.5|31.3|||Chi-squared|||||31.3|9.5|<0.001
73895246|NCT00966875|147323415|SUPERIORITY_OR_OTHER|||||||0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.017
73895247|NCT00966875|147323415|SUPERIORITY_OR_OTHER|||||||0.066||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.066
73895248|NCT00966875|147323417|SUPERIORITY_OR_OTHER|||||||0.538||||||P-value is for Week 12.|Fisher Exact|||||||0.538
73895249|NCT00966875|147323417|SUPERIORITY_OR_OTHER|||||||0.515||||||P-value is for Week 12.|Fisher Exact|||||||0.515
73802922|NCT00529087|147155603|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|7.0||||0.212||95.0|-4.0|18.0|||Chi-squared|||||18.0|-4.0|0.212
73802923|NCT00529087|147155604|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.||||<0.001
73802924|NCT00529087|147155604|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.||||<0.001
73802925|NCT00529087|147155605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.5|||<|0.001||95.0|11.2|17.9|||ANOVA|Treatment as a factor||1 hour||17.9|11.2|<0.001
73802926|NCT00529087|147155605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||<|0.001||95.0|4.6|11.4|||ANOVA|Treatment as a factor||1 hour||11.4|4.6|<0.001
73802927|NCT00529087|147155605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.5|||<|0.001||95.0|14.4|22.5|||ANOVA|Treatment as a factor||2 hours||22.5|14.4|<0.001
73802928|NCT00529087|147155605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.4|||<|0.001||95.0|6.3|14.5|||ANOVA|Treatment as a factor||2 hours||14.5|6.3|<0.001
73895250|NCT00966875|147323417|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for Week 12.|Fisher Exact|||||||0.030
73895251|NCT00966875|147323417|SUPERIORITY_OR_OTHER|||||||0.053||||||P-value is for Week 12.|Fisher Exact|||||||0.053
73895252|NCT00966875|147323417|SUPERIORITY_OR_OTHER|||||||0.393||||||P-value is for Week 12.|Fisher Exact|||||||0.393
73895253|NCT00966875|147323417|SUPERIORITY_OR_OTHER|||||||0.077||||||P-value is for Week 12.|Fisher Exact|||||||0.077
73895254|NCT00966875|147323417|SUPERIORITY_OR_OTHER|||||||0.105||||||P-value is for Week 12.|Fisher Exact|||||||0.105
73895255|NCT01589653|147323425|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently when the p-value for the one-sided test of H0: D \> 0.4% against HA: D ≤ 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).|Treatment difference|-0.23|||<|0.001|TWO_SIDED|95.0|-0.54|0.08|||Regression, Linear|Analyses were adjusted for treatment, strata, country and baseline HbA1c||The null-hypothesis was tested against the alternative hypothesis of non-inferiority as given by: H0: D \> 0.4% against HA: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (subject-driven titration minus investigator-driven titration).||0.08|-0.54|<0.001
73895256|NCT04657666|147323430|SUPERIORITY||Combined least mean square difference|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7152|TWO_SIDED|95.0|-0.16|0.23||Based on a combination of 300 linear mixed models for crossover data on the response variable change from baseline in LLMT-6 with period level LLMT-6 baseline covariate, treatment group, period, and sequence as fixed effects.|Mixed Models Analysis|Pattern mixture model (PMM) control-based imputation, mixed model repeated measures (MMRM)||||0.23|-0.16|0.7152
73895257|NCT02386189|147323450|SUPERIORITY||Mean Difference (Net)|-4.65|STANDARD_DEVIATION|7.3||0.02|TWO_SIDED||||||t-test, 2 sided|||The t-test was conducted on change between baseline and 12-month follow-up.||||0.02
73895258|NCT02386189|147323451|SUPERIORITY||Mean Difference (Net)|2.91|STANDARD_DEVIATION|5.5||0.06|TWO_SIDED||||||t-test, 2 sided|||||||0.06
73895259|NCT02386189|147323452|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_DEVIATION|2.7||0.71|TWO_SIDED||||||t-test, 2 sided|||||||0.71
73895260|NCT02386189|147323453|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
73895261|NCT02386189|147323454|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_DEVIATION|0.15||0.75|TWO_SIDED||||||t-test, 2 sided|||||||0.75
73895262|NCT02386189|147323455|SUPERIORITY||Mean Difference (Final Values)|-3.6|STANDARD_DEVIATION|7.1||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
73895263|NCT02386189|147323456|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|8.9||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
73895264|NCT04975438|147323491|OTHER||Posterior Median Difference|-33.21|||||TWO_SIDED|95.0|-50.96|-14.84|||||The posterior median of the difference (GSK1070806 - placebo) and 95% credible interval in PCFB in the EASI is presented. Analysis was performed using Bayesian analysis under the hypothetical strategy using an informative prior (robust MAP prior).|||-14.84|-50.96|
73895265|NCT04975438|147323492|OTHER||Posterior Median Difference|-9.68|||||TWO_SIDED|95.0|-15.7|-3.6|||||The posterior median of the difference (GSK1070806 - placebo) and 95% credible interval in PCFB in the EASI is presented. Analysis was performed using Bayesian analysis with vague priors and adjusting for baseline EASI.|||-3.60|-15.70|
73895266|NCT00865280|147323516|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-2.0|||||TWO_SIDED|95.0|-12.4|8.5|||||The 95% confidence interval (CI) was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.5|-12.4|
73895267|NCT00865280|147323517|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-3.6|||||TWO_SIDED|95.0|-15.5|8.3|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.3|-15.5|
73895268|NCT00865280|147323518|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|7.7|||||TWO_SIDED|95.0|-11.2|26.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||26.6|-11.2|
73895269|NCT00865280|147323519|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.3|||||TWO_SIDED|95.0|-8.3|7.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||7.6|-8.3|
73895270|NCT00865280|147323520|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|7.7|||||TWO_SIDED|95.0|-11.2|26.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||26.6|-11.2|
73802929|NCT00529087|147155605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.3|||<|0.001||95.0|15.0|23.5|||ANOVA|Treatment as a factor||3 hours||23.5|15.0|<0.001
73802930|NCT00529087|147155605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.7|15.3|||ANOVA|Treatment as a factor||3 hours||15.3|6.7|<0.001
73802931|NCT00529087|147155605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.5|||<|0.001||95.0|15.2|23.9|||ANOVA|Treatment as a factor||4 hours||23.9|15.2|<0.001
73802932|NCT00529087|147155605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.6|15.4|||ANOVA|Treatment as a factor||4 hours||15.4|6.6|<0.001
73802933|NCT00529087|147155605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.7|||<|0.001||95.0|15.2|24.1|||ANOVA|Treatment as a factor||6 hours||24.1|15.2|<0.001
73895271|NCT00865280|147323521|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.3|||||TWO_SIDED|95.0|-8.3|7.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||7.6|-8.3|
73895272|NCT01168986|147323526|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mixed Models Analysis|||||||0.10
73895273|NCT01168986|147323527|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Mixed Models Analysis|||||||0.18
73895274|NCT01168986|147323528|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Mixed Models Analysis|||||||0.87
73895275|NCT01168986|147323529|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
73895276|NCT01419197|147323595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528|||<|0.0001|TWO_SIDED|95.0|0.422|0.661||The two-sided stratified log-rank test was used to compare progression-free survival between the two treatment arms at the overall two-sided significance level of 0.5%.|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||0.661|0.422|<0.0001
73802934|NCT00529087|147155605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|||<|0.001||95.0|6.2|15.2|||ANOVA|Treatment as a factor||6 hours||15.2|6.2|<0.001
73802935|NCT00529087|147155606|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|21.0|||<|0.001||95.0|10.2|31.9|||Chi-squared|||||31.9|10.2|<0.001
73802936|NCT00529087|147155606|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|5.6||||0.316||95.0|-5.3|16.5|||Chi-squared|||||16.5|-5.3|0.316
73802937|NCT00529087|147155607|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.7|||<|0.001||95.0|9.4|30.1|||Chi-squared|||||30.1|9.4|<0.001
73802938|NCT00529087|147155607|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|13.3||||0.016||95.0|2.6|24.0|||Chi-squared|||||24.0|2.6|0.016
73802939|NCT00529087|147155608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|||<|0.001||95.0|1.0|1.9|||ANCOVA|Treatment as factor, Baseline as covariate||||1.9|1.0|<0.001
73802940|NCT00529087|147155608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.102||95.0|-0.1|0.8|||ANCOVA|Treatment as factor, Baseline as covariate||||0.8|-0.1|0.102
73802941|NCT00529087|147155609|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.1|||<|0.001||95.0|0.6|1.5|||ANCOVA|||||1.5|0.6|<0.001
73802942|NCT00529087|147155609|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|||<|0.001||95.0|0.0|0.9|||ANCOVA|||||0.9|0.0|<0.001
73802943|NCT00529087|147155610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|||<|0.001||95.0|0.8|1.6|||ANCOVA|Treatment as factor, Baseline as covariate||||1.6|0.8|<0.001
73802944|NCT00529087|147155610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.012||95.0|0.1|0.9|||ANCOVA|Treatment as factor, Baseline as covariate||||0.9|0.1|0.012
73802945|NCT00529087|147155611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.002||95.0|0.2|0.7|||ANCOVA|Treatment as factor, Baseline as covariate||||0.7|0.2|0.002
73802946|NCT00529087|147155611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.119||95.0|-0.1|0.5|||ANCOVA|Treatment as factor, Baseline as covariate||||0.5|-0.1|0.119
73802947|NCT00529087|147155612|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.3||||0.008||95.0|-0.5|-0.1|||ANCOVA|Treatment as factor, Baseline as covariate||||-0.1|-0.5|0.008
73802948|NCT00529087|147155612|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.2||||0.015||95.0|-0.5|0.0|||ANCOVA|Treatment as factor, Baseline as covariate||||0.0|-0.5|0.015
73802949|NCT00529087|147155615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.731||95.0|-5.4|7.7|||ANCOVA|Treatment as factor, Baseline as covariate||||7.7|-5.4|0.731
73802950|NCT00529087|147155615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.779||95.0|-5.6|7.5|||ANCOVA|Treatment as factor, Baseline as covariate||||7.5|-5.6|0.779
73802951|NCT00529087|147155616|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|5.6||||0.023||95.0|0.8|10.4|||ANCOVA|Treatment as factor, baseline as covariate||||10.4|0.8|0.023
73802952|NCT00529087|147155616|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.8||||0.258||95.0|-2.0|7.6|||ANCOVA|Treatment as factor, baseline as covariate||||7.6|-2.0|0.258
73802953|NCT00529087|147155618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.0||||0.071||95.0|-0.6|14.5|||ANCOVA|Treatment as factor, baseline as covariate||||14.5|-0.6|0.071
73802954|NCT00529087|147155618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.6||||0.087||95.0|-1.0|14.2|||ANCOVA|Treatment as factor, baseline as covariate||||14.2|-1.0|0.087
73802955|NCT00529087|147155619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6||||0.038||95.0|0.4|14.7|||ANCOVA|Treatment as factor, baseline as covariate||||14.7|0.4|0.038
73802956|NCT00529087|147155619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.3||||0.237||95.0|-2.8|11.5|||ANCOVA|Treatment as factor, baseline as covariate||||11.5|-2.8|0.237
73802957|NCT00833105|147155647|SUPERIORITY_OR_OTHER||||||<|0.025|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||<0.025
73802958|NCT00833105|147155648|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.299
73802959|NCT00833105|147155649|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.459
73895277|NCT01419197|147323596|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.552||||0.0034|TWO_SIDED|95.0|0.369|0.826||The 2-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this first OS interim analysis was HR\<0.363 (p-value \< 0.0000013).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||0.826|0.369|0.0034
73802960|NCT00833105|147155650|SUPERIORITY_OR_OTHER|||||||0.343|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.343
73895278|NCT01419197|147323597|SUPERIORITY_OR_OTHER||Difference in Response Percentage|22.7|||<|0.0001|TWO_SIDED|95.0|16.2|29.2|||Mantel Haenszel|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||29.2|16.2|<0.0001
73802961|NCT00833105|147155651|SUPERIORITY_OR_OTHER|||||||0.951|TWO_SIDED||||||Mixed Models Analysis|Random subject effects||||||0.951
73802962|NCT00833105|147155652|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.371
73802963|NCT00833105|147155653|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.164
73802964|NCT00833105|147155654|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon Signed-Rank|No multiple comparison procedure||Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.||||<0.01
73802965|NCT00833105|147155655|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||No multiple comparison procedure performed|Wilcoxon Signed Rank Test|||||||<0.05
73802966|NCT00833105|147155656|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||No multiple comparison procedure|Wilcoxon Signed Rank Test|||||||<0.0001
73802967|NCT00833105|147155657|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED|||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test|||||||<0.005
73802968|NCT00833105|147155658|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test|||||||<0.001
73802969|NCT00833105|147155659|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple comparisons adjustment.|Wilcoxon Signed Rank Test|||||||<0.001
73802970|NCT03656068|147155724|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|0.003||||0.0039|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.0039
73802971|NCT03656068|147155725|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|10.0||||0.0026|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.0026
73802972|NCT03656068|147155726|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|0.002||||0.5555|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.5555
73802973|NCT03656068|147155727|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|1.72||||0.3778|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.3778
73802974|NCT03656068|147155728|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-8.1||||0.4638|TWO_SIDED|95.0|-31.0|14.8||p-value for testing mean = 0|t-test, 2 sided|||||14.8|-31.0|0.4638
73802975|NCT03656068|147155729|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.65||||0.6532|TWO_SIDED|95.0|-9.26|5.97||p-value for testing mean = 0|t-test, 2 sided|||||5.97|-9.26|0.6532
73802976|NCT03656068|147155730|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.38||||0.7254|TWO_SIDED|95.0|-1.86|2.61||p-value for testing mean = 0|t-test, 2 sided|||||2.61|-1.86|0.7254
73802977|NCT03656068|147155731|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|8.77||||0.3772|TWO_SIDED|95.0|-11.7|29.25||p-value for testing mean = 0|t-test, 2 sided|||||29.25|-11.70|0.3772
73802978|NCT03656068|147155732|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.12||||0.5799|TWO_SIDED|95.0|-0.56|0.33||p-value for testing mean = 0|t-test, 2 sided|||||0.33|-0.56|0.5799
73802979|NCT03656068|147155733|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.89||||0.7088|TWO_SIDED|95.0|-12.65|8.87||p-value for testing mean = 0|t-test, 2 sided|||||8.87|-12.65|0.7088
73802980|NCT03656068|147155734|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.35||||0.0609|TWO_SIDED|95.0|-0.72|0.02||p-value for testing mean = 0|t-test, 2 sided|||||0.02|-0.72|0.0609
73802981|NCT03656068|147155735|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-6.61||||0.1556|TWO_SIDED|95.0|-16.16|2.94||p-value for testing mean = 0|t-test, 2 sided|||||2.94|-16.16|0.1556
73802982|NCT03656068|147155736|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-14.6||||0.0709|TWO_SIDED|95.0|-30.6|1.4||p-value for testing mean = 0|t-test, 2 sided|||||1.4|-30.6|0.0709
73802983|NCT03656068|147155737|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-3.61||||0.1799|TWO_SIDED|95.0|-9.02|1.81||p-value for testing mean = 0|t-test, 2 sided|||||1.81|-9.02|0.1799
73802984|NCT03656068|147155738|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-6.8||||0.3306|TWO_SIDED|95.0|-21.2|7.6||p-value for testing mean = 0|t-test, 2 sided|||||7.6|-21.2|0.3306
73802985|NCT03656068|147155739|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.94||||0.4504|TWO_SIDED|95.0|-7.25|3.37||p-value for testing mean = 0|t-test, 2 sided|||||3.37|-7.25|0.4504
73802986|NCT03656068|147155740|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|33.8||||0.1349|TWO_SIDED|95.0|-11.5|79.0||p-value for testing mean = 0|t-test, 2 sided|||||79.0|-11.5|0.1349
73802987|NCT03656068|147155741|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|76.24||||0.0117|TWO_SIDED|95.0|19.04|133.43||p-value for testing mean = 0|t-test, 2 sided|||||133.43|19.04|0.0117
73802988|NCT03656068|147155742|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|31.3||||0.4281|TWO_SIDED|95.0|-50.3|112.9||p-value for testing mean = 0|t-test, 2 sided|||||112.9|-50.3|0.4281
73802989|NCT03656068|147155743|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|117.37||||0.0407|TWO_SIDED|95.0|5.6|229.14||p-value for testing mean = 0|t-test, 2 sided|||||229.14|5.60|0.0407
73802990|NCT03656068|147155744|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|47.28||||0.7065|TWO_SIDED|95.0|-210.9|305.46||p-value for testing mean = 0|t-test, 2 sided|||||305.46|-210.90|0.7065
73895279|NCT01419197|147323599|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|12.6||||0.0011|TWO_SIDED|95.0|5.03|20.09||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||6-month survival||20.09|5.03|0.0011
73802991|NCT03656068|147155745|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|43.11||||0.1693|TWO_SIDED|95.0|-19.95|106.17||p-value for testing mean = 0|t-test, 2 sided|||||106.17|-19.95|0.1693
73802992|NCT03656068|147155746|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-48.14||||0.7099|TWO_SIDED|95.0|-317.64|221.36||p-value for testing mean = 0|t-test, 2 sided|||||221.36|-317.64|0.7099
73802993|NCT03656068|147155747|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|30.03||||0.3597|TWO_SIDED|95.0|-37.48|97.55||p-value for testing mean = 0|t-test, 2 sided|||||97.55|-37.48|0.3597
73802994|NCT03656068|147155748|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|169.0||||0.9893|TWO_SIDED|95.0|-25908.2|26246.2||p-value for testing mean = 0|t-test, 2 sided|||||26246.2|-25908.2|0.9893
73802995|NCT03656068|147155749|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|13.82||||0.1454|TWO_SIDED|95.0|-5.21|32.85||p-value for testing mean = 0|t-test, 2 sided|||||32.85|-5.21|0.1454
73802996|NCT03656068|147155750|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3016.8||||0.8089|TWO_SIDED|95.0|-22996.2|29029.7||p-value for testing mean = 0|t-test, 2 sided|||||29029.7|-22996.2|0.8089
73802997|NCT03656068|147155751|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|12.78||||0.1365|TWO_SIDED|95.0|-4.5|30.06||p-value for testing mean = 0|t-test, 2 sided|||||30.06|-4.50|0.1365
73802998|NCT03656068|147155752|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|28.954||||0.1322|TWO_SIDED|95.0|-9.525|67.433||p-value for testing mean = 0|t-test, 2 sided|||||67.433|-9.525|0.1322
73802999|NCT03656068|147155753|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|23.99||||0.1062|TWO_SIDED|95.0|-5.59|53.57|||t-test, 2 sided|p-value for testing mean = 0||||53.57|-5.59|0.1062
73803000|NCT03656068|147155754|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|28.311||||0.0831|TWO_SIDED|95.0|-4.151|60.774||p-value for testing mean = 0|t-test, 2 sided|||||60.774|-4.151|0.0831
73895280|NCT01419197|147323599|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|11.7||||0.1805|TWO_SIDED|95.0|-5.41|28.75||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||1-year survival||28.75|-5.41|0.1805
73803001|NCT03656068|147155755|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|32.72||||0.0543|TWO_SIDED|95.0|-0.69|66.13||p-value for testing mean = 0|t-test, 2 sided|||||66.13|-0.69|0.0543
73803002|NCT03656068|147155756|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.056||||0.6325|TWO_SIDED|95.0|-0.185|0.298||p-value for testing mean = 0|t-test, 2 sided|||||0.298|-0.185|0.6325
73803003|NCT03656068|147155757|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.46||||0.6925|TWO_SIDED|95.0|-1.94|2.87||p-value for testing mean = 0|t-test, 2 sided|||||2.87|-1.94|0.6925
73803004|NCT03656068|147155758|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.161||||0.2733|TWO_SIDED|95.0|-0.14|0.462|||t-test, 2 sided|||||0.462|-0.140|0.2733
73803005|NCT03656068|147155759|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|1.47||||0.3288|TWO_SIDED|95.0|-1.63|4.56||p-value for testing mean = 0|t-test, 2 sided|||||4.56|-1.63|0.3288
73803006|NCT03656068|147155760|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|5.649||||0.9271|TWO_SIDED|95.0|-121.923|133.22||p-value for testing mean = 0|t-test, 2 sided|||||133.220|-121.923|0.9271
73803007|NCT03656068|147155761|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.89||||0.9244|TWO_SIDED|95.0|-18.58|20.37||p-value for testing mean = 0|t-test, 2 sided|||||20.37|-18.58|0.9244
73803008|NCT03656068|147155762|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-30.244||||0.7288|TWO_SIDED|95.0|-211.93|151.441||p-value for testing mean = 0|t-test, 2 sided|||||151.441|-211.930|0.7288
73803009|NCT03656068|147155763|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.34||||0.7824|TWO_SIDED|95.0|-21.85|28.52||p-value for testing mean = 0|t-test, 2 sided|||||28.52|-21.85|0.7824
73803010|NCT03656068|147155764|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-47.629||||0.6448|TWO_SIDED|95.0|-260.433|165.176||p-value for testing mean = 0|t-test, 2 sided|||||165.176|-260.433|0.6448
73803011|NCT03656068|147155765|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.38||||0.9806|TWO_SIDED|95.0|-32.04|32.8||p-value for testing mean = 0|t-test, 2 sided|||||32.80|-32.04|0.9806
73803012|NCT03656068|147155766|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-113.616||||0.3256|TWO_SIDED|95.0|-351.124|123.891||p-value for testing mean = 0|t-test, 2 sided|||||123.891|-351.124|0.3256
73803013|NCT03656068|147155767|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|8.78||||0.6582|TWO_SIDED|95.0|-32.52|50.09||p-value for testing mean = 0|t-test, 2 sided|||||50.09|-32.52|0.6582
73803014|NCT03656068|147155768|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2438||||0.5459|TWO_SIDED|95.0|-1.0847|0.5972||p-value for testing mean = 0|t-test, 2 sided|||||0.5972|-1.0847|0.5459
73803015|NCT03656068|147155769|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|23.91||||0.286|TWO_SIDED|95.0|-22.15|69.97|||t-test, 2 sided|||||69.97|-22.15|0.2860
73803016|NCT03656068|147155770|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2893||||0.4887|TWO_SIDED|95.0|-1.158|0.5794||p-value for testing mean = 0|t-test, 2 sided|||||0.5794|-1.1580|0.4887
73803017|NCT03656068|147155771|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|30.27||||0.361|TWO_SIDED|95.0|-38.21|98.75||p-value for testing mean = 0|t-test, 2 sided|||||98.75|-38.21|0.3610
73803018|NCT03656068|147155772|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.63||||0.4945|TWO_SIDED|95.0|-2.51|1.26||p-value for testing mean = 0|t-test, 2 sided|||||1.26|-2.51|0.4945
73803019|NCT03656068|147155773|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.99||||0.8191|TWO_SIDED|95.0|-9.94|7.95||p-value for testing mean = 0|t-test, 2 sided|||||7.95|-9.94|0.8191
73803020|NCT03656068|147155774|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-3.22||||0.0243|TWO_SIDED|95.0|-5.96|-0.47||p-value for testing mean = 0|t-test, 2 sided|||||-0.47|-5.96|0.0243
73803021|NCT03656068|147155775|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-9.94||||0.0493|TWO_SIDED|95.0|-19.84|-0.04||p-value for testing mean = 0|t-test, 2 sided|||||-0.04|-19.84|0.0493
73895281|NCT01419197|147323600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.115||||0.4952|TWO_SIDED|95.0|0.819|1.517|||Log Rank|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||1.517|0.819|0.4952
73803022|NCT03656068|147155776|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.6||||0.3066|TWO_SIDED|95.0|-0.59|1.79||p-value for testing mean = 0|t-test, 2 sided|||||1.79|-0.59|0.3066
73803023|NCT03656068|147155777|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.4||||0.2671|TWO_SIDED|95.0|-2.82|9.63||p-value for testing mean = 0|t-test, 2 sided|||||9.63|-2.82|0.2671
73803024|NCT03656068|147155778|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.11||||0.8241|TWO_SIDED|95.0|-0.94|1.16||p-value for testing mean = 0|t-test, 2 sided|||||1.16|-0.94|0.8241
73803025|NCT03656068|147155779|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|1.1||||0.7587|TWO_SIDED|95.0|-6.37|8.57||p-value for testing mean = 0|t-test, 2 sided|||||8.57|-6.37|0.7587
73803026|NCT03656068|147155780|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.567||||0.3784|TWO_SIDED|95.0|-1.88|0.746||p-value for testing mean = 0|t-test, 2 sided|||||0.746|-1.880|0.3784
73803027|NCT03656068|147155781|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-4.64||||0.3526|TWO_SIDED|95.0|-14.8|5.53||p-value for testing mean = 0|t-test, 2 sided|||||5.53|-14.80|0.3526
73803028|NCT03656068|147155782|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.098||||0.9218|TWO_SIDED|95.0|-1.978|2.173||p-value for testing mean = 0|t-test, 2 sided|||||2.173|-1.978|0.9218
73803029|NCT03656068|147155783|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.15||||0.9833|TWO_SIDED|95.0|-14.71|15.01||p-value for testing mean = 0|t-test, 2 sided|||||15.01|-14.71|0.9833
73803030|NCT03656068|147155784|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|12.68||||0.3957|TWO_SIDED|95.0|-17.79|43.16||p-value for testing mean = 0|t-test, 2 sided|||||43.16|-17.79|0.3957
73803031|NCT03656068|147155785|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.81||||0.344|TWO_SIDED|95.0|-4.39|12.01||p-value for testing mean = 0|t-test, 2 sided|||||12.01|-4.39|0.3440
73803032|NCT03656068|147155786|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|15.22||||0.0607|TWO_SIDED|95.0|-0.77|31.21||p-value for testing mean = 0|t-test, 2 sided|||||31.21|-0.77|0.0607
73803033|NCT03656068|147155787|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|5.83||||0.0644|TWO_SIDED|95.0|-0.39|12.05||p-value for testing mean = 0|t-test, 2 sided|||||12.05|-0.39|0.0644
73803034|NCT03656068|147155788|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.3665||||0.0487|TWO_SIDED|95.0|-0.7306|-0.0023||p-value for testing mean = 0|t-test, 2 sided|||||-0.0023|-0.7306|0.0487
73803035|NCT03656068|147155789|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|16.64||||0.5919|TWO_SIDED|95.0|-47.25|80.54||p-value for testing mean = 0|t-test, 2 sided|||||80.54|-47.25|0.5919
73803036|NCT03656068|147155790|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2679||||0.1272|TWO_SIDED|95.0|-0.634|0.0983||p-value for testing mean = 0|t-test, 2 sided|||||0.0983|-0.6340|0.1272
73803037|NCT03656068|147155791|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|15.02||||0.5881|TWO_SIDED|95.0|-47.55|77.59||p-value for testing mean = 0|t-test, 2 sided|||||77.59|-47.55|0.5881
73803038|NCT03656068|147155792|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.18||||0.1458|TWO_SIDED|95.0|-0.42|0.07|||t-test, 2 sided|||||0.07|-0.42|0.1458
73803039|NCT03656068|147155793|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-11.53||||0.1495|TWO_SIDED|95.0|-27.61|4.54||p-value for testing mean = 0|t-test, 2 sided|||||4.54|-27.61|0.1495
73803040|NCT03656068|147155794|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.12||||0.3174|TWO_SIDED|95.0|-0.4|0.15||p-value for testing mean = 0|t-test, 2 sided|||||0.15|-0.40|0.3174
73803041|NCT03656068|147155795|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-8.02||||0.242|TWO_SIDED|95.0|-22.86|6.82||p-value for testing mean = 0|t-test, 2 sided|||||6.82|-22.86|0.2420
73803042|NCT00708552|147155806|SUPERIORITY||Mean Difference (Net)|1.1||||0.159|TWO_SIDED|95.0|-0.4|2.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 24||2.7|-0.4|0.159
73803043|NCT00708552|147155806|SUPERIORITY||Mean Difference (Net)|0.7||||0.41|TWO_SIDED|95.0|-0.9|2.3|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 24||2.3|-0.9|0.410
73803044|NCT00708552|147155806|SUPERIORITY||Mean Difference (Net)|-0.2||||0.821|TWO_SIDED|95.0|-1.6|1.2|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepezil at Week 24||1.2|-1.6|0.821
73803045|NCT00708552|147155807|SUPERIORITY||Mean Difference (Net)|0.2||||0.254|TWO_SIDED|95.0|-0.1|0.5|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.1|0.254
73803046|NCT00708552|147155807|SUPERIORITY||Mean Difference (Net)|-0.1||||0.394|TWO_SIDED|95.0|-0.4|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 24||0.2|-0.4|0.394
73803047|NCT00708552|147155807|SUPERIORITY||Mean Difference (Net)|-0.3||||0.049|TWO_SIDED|95.0|-0.6|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepezil at Week 24||-0.0|-0.6|0.049
73803048|NCT00708552|147155808|SUPERIORITY||Mean Difference (Net)|-1.6||||0.423|TWO_SIDED|95.0|-5.6|2.3|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-15mg at Week 24||2.3|-5.6|0.423
73895282|NCT01419197|147323602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.0007|TWO_SIDED|95.0|0.539|0.85||The two-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this second and final interim analysis was HR\<0.748 (p value \< 0.012).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease versus no visceral disease).||0.850|0.539|0.0007
73895283|NCT01419197|147323603|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|12.4||||0.0003|TWO_SIDED|95.0|5.67|19.14||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||6-month survival||19.14|5.67|0.0003
73803049|NCT00708552|147155808|SUPERIORITY||Mean Difference (Net)|-2.1||||0.305|TWO_SIDED|95.0|-6.1|1.9|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-35mg at Week 24||1.9|-6.1|0.305
73803050|NCT00708552|147155808|SUPERIORITY||Mean Difference (Net)|2.0||||0.282|TWO_SIDED|95.0|-1.7|5.7|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs Donepezil at Week 24||5.7|-1.7|0.282
73803051|NCT00708552|147155809|SUPERIORITY||Mean Difference (Net)|1.4||||0.096|TWO_SIDED|95.0|-0.3|3.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24||3.1|-0.3|0.096
73803052|NCT00708552|147155809|SUPERIORITY||Mean Difference (Net)|1.0||||0.281|TWO_SIDED|95.0|-0.8|2.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24||2.8|-0.8|0.281
73895284|NCT01419197|147323603|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|11.0||||0.0104|TWO_SIDED|95.0|2.58|19.33||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||1-year survival||19.33|2.58|0.0104
73895285|NCT00146848|147323604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.75||0.86|TWO_SIDED|95.0|-3.14|3.74|||t-test, 2 sided|||The changes in quality of life were compared between groups using two-sided t-tests.||3.74|-3.14|0.86
73803053|NCT00708552|147155809|SUPERIORITY||Mean Difference (Net)|0.4||||0.63|TWO_SIDED|95.0|-1.1|1.9|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24||1.9|-1.1|0.630
73803054|NCT00708552|147155809|SUPERIORITY||Mean Difference (Net)|-1.1||||0.655|TWO_SIDED|95.0|-5.7|3.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24||3.6|-5.7|0.655
73803055|NCT00708552|147155809|SUPERIORITY||Mean Difference (Net)|-1.5||||0.545|TWO_SIDED|95.0|-6.2|3.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24||3.3|-6.2|0.545
73803056|NCT00708552|147155809|SUPERIORITY||Mean Difference (Net)|2.4||||0.27|TWO_SIDED|95.0|-1.9|6.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 24||6.8|-1.9|0.270
73803057|NCT00708552|147155810|SUPERIORITY||Mean Difference (Net)|1.5||||0.138|TWO_SIDED|95.0|-0.5|3.6|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24||3.6|-0.5|0.138
73803058|NCT00708552|147155810|SUPERIORITY||Mean Difference (Net)|1.3||||0.216|TWO_SIDED|95.0|-0.7|3.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24||3.2|-0.7|0.216
73803059|NCT00708552|147155810|SUPERIORITY||Mean Difference (Net)|-0.1||||0.921|TWO_SIDED|95.0|-1.9|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24||1.7|-1.9|0.921
73803060|NCT00708552|147155810|SUPERIORITY||Mean Difference (Net)|-2.1||||0.41|TWO_SIDED|95.0|-7.0|2.9|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24||2.9|-7.0|0.410
73803061|NCT00708552|147155810|SUPERIORITY||Mean Difference (Net)|-1.1||||0.667|TWO_SIDED|95.0|-5.9|3.8|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24||3.8|-5.9|0.667
73803062|NCT00708552|147155810|SUPERIORITY||Mean Difference (Net)|2.7||||0.246|TWO_SIDED|95.0|-1.9|7.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 24||7.2|-1.9|0.246
73803063|NCT00708552|147155811|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-15mg at Week 24||0.6|-0.1|0.146
73803064|NCT00708552|147155811|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.733|TWO_SIDED|95.0|-0.4|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-35mg at Week 24||0.3|-0.4|0.733
73803065|NCT00708552|147155811|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.145|TWO_SIDED|95.0|-0.5|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs Donepezil at Week 24||0.1|-0.5|0.145
73803066|NCT00708552|147155812|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.295|TWO_SIDED|95.0|-0.2|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-15mg at Week 24||0.6|-0.2|0.295
73803067|NCT00708552|147155812|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.495|TWO_SIDED|95.0|-0.5|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-35mg at Week 24||0.2|-0.5|0.495
73803068|NCT00708552|147155812|SUPERIORITY||Mean Difference (Net)|-0.3||||0.166|TWO_SIDED|95.0|-0.6|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs Donepezil at Week 24||0.1|-0.6|0.166
73803069|NCT00708552|147155813|SUPERIORITY||Mean Difference (Net)|0.1||||0.847|TWO_SIDED|95.0|-1.1|1.4|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 12||1.4|-1.1|0.847
73803070|NCT00708552|147155813|SUPERIORITY||Mean Difference (Net)|-0.1||||0.833|TWO_SIDED|95.0|-1.4|1.1|||Mixed Models Analysis|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 12||1.1|-1.4|0.833
73803071|NCT00708552|147155813|SUPERIORITY||Mean Difference (Net)|-0.5||||0.443|TWO_SIDED|95.0|-1.6|0.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepzil at Week 12||0.7|-1.6|0.443
73803072|NCT00708552|147155814|SUPERIORITY||Mean Difference (Net)|0.1||||0.32|TWO_SIDED|95.0|-0.1|0.3|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 12||0.3|-0.1|0.320
73803073|NCT00708552|147155814|SUPERIORITY||Mean Difference (Net)|0.0||||0.927|TWO_SIDED|95.0|-0.2|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 12||0.2|-0.2|0.927
73803074|NCT00708552|147155814|SUPERIORITY||Mean Difference (Net)|-0.2||||0.059|TWO_SIDED|95.0|-0.4|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepzil at Week 12||0.0|-0.4|0.059
73803075|NCT00708552|147155815|SUPERIORITY||Mean Difference (Net)|-1.9||||0.257|TWO_SIDED|95.0|-5.2|1.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-15mg at Week 12||1.4|-5.2|0.257
73803076|NCT00708552|147155815|SUPERIORITY||Mean Difference (Net)|0.9||||0.57|TWO_SIDED|95.0|-2.2|4.0|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-35mg at Week 12||4.0|-2.2|0.570
73803077|NCT00708552|147155815|SUPERIORITY||Mean Difference (Net)|3.4||||0.031|TWO_SIDED|95.0|0.3|6.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs Donepzil at Week 12||6.4|0.3|0.031
73803078|NCT00708552|147155816|SUPERIORITY||Mean Difference (Net)|0.2||||0.798|TWO_SIDED|95.0|-1.1|1.5|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12||1.5|-1.1|0.798
73803079|NCT00708552|147155816|SUPERIORITY||Mean Difference (Net)|0.1||||0.918|TWO_SIDED|95.0|-1.3|1.4|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.3|0.918
73803080|NCT00708552|147155816|SUPERIORITY||Mean Difference (Net)|0.1||||0.924|TWO_SIDED|95.0|-1.2|1.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12||1.3|-1.2|0.924
73803081|NCT00708552|147155816|SUPERIORITY||Mean Difference (Net)|-0.8||||0.676|TWO_SIDED|95.0|-4.7|3.0|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12||3.0|-4.7|0.676
73803082|NCT00708552|147155816|SUPERIORITY||Mean Difference (Net)|3.1||||0.086|TWO_SIDED|95.0|-0.4|6.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12||6.7|-0.4|0.086
73803083|NCT00708552|147155816|SUPERIORITY||Mean Difference (Net)|4.2||||0.021|TWO_SIDED|95.0|0.6|7.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 12||7.7|0.6|0.021
73803084|NCT00708552|147155817|SUPERIORITY||Mean Difference (Net)|0.1||||0.908|TWO_SIDED|95.0|-1.5|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12||1.7|-1.5|0.908
73803085|NCT00708552|147155817|SUPERIORITY||Mean Difference (Net)|-0.2||||0.826|TWO_SIDED|95.0|-1.7|1.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.7|0.826
73803086|NCT00708552|147155817|SUPERIORITY||Mean Difference (Net)|-1.2||||0.088|TWO_SIDED|95.0|-2.7|0.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12||0.2|-2.7|0.088
73803087|NCT00708552|147155817|SUPERIORITY||Mean Difference (Net)|-3.6||||0.053|TWO_SIDED|95.0|-7.3|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12||0.0|-7.3|0.053
73803088|NCT00708552|147155817|SUPERIORITY||Mean Difference (Net)|-0.4||||0.848|TWO_SIDED|95.0|-4.0|3.3|||Mixed Models Analysis|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12||3.3|-4.0|0.848
73803089|NCT00708552|147155817|SUPERIORITY||Mean Difference (Net)|4.7||||0.011|TWO_SIDED|95.0|1.1|8.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 12||8.2|1.1|0.011
73803090|NCT00708552|147155818|SUPERIORITY||Mean Difference (Net)|0.1||||0.671|TWO_SIDED|95.0|-0.2|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12||0.3|-0.2|0.671
73803091|NCT00708552|147155818|SUPERIORITY||Mean Difference (Net)|-0.1||||0.413|TWO_SIDED|95.0|-0.4|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12||0.2|-0.4|0.413
73803092|NCT00708552|147155818|SUPERIORITY||Mean Difference (Net)|-0.1||||0.245|TWO_SIDED|95.0|-0.4|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12||0.1|-0.4|0.245
73803093|NCT00708552|147155819|SUPERIORITY||Mean Difference (Net)|0.1||||0.369|TWO_SIDED|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12||0.4|-0.2|0.369
73803094|NCT00708552|147155819|SUPERIORITY||Mean Difference (Net)|0.1||||0.55|TWO_SIDED|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12||0.4|-0.2|0.550
73803095|NCT00708552|147155819|SUPERIORITY||Mean Difference (Net)|-0.3||||0.082|TWO_SIDED|95.0|-0.5|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12||0.0|-0.5|0.082
73803096|NCT00708552|147155820|SUPERIORITY||Mean Difference (Net)|-0.7||||0.417|TWO_SIDED|95.0|-2.4|1.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 12||1.0|-2.4|0.417
73803097|NCT00708552|147155820|SUPERIORITY||Mean Difference (Net)|0.3||||0.725|TWO_SIDED|95.0|-1.4|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 12||2.0|-1.4|0.725
73803098|NCT00708552|147155820|SUPERIORITY||Mean Difference (Net)|0.6||||0.506|TWO_SIDED|95.0|-1.1|2.2|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 12||2.2|-1.1|0.506
73803099|NCT00708552|147155820|SUPERIORITY||Mean Difference (Net)|-0.3||||0.723|TWO_SIDED|95.0|-2.3|1.6|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 24||1.6|-2.3|0.723
73803100|NCT00708552|147155820|SUPERIORITY||Median Difference (Net)|-0.1||||0.919|TWO_SIDED|95.0|-2.2|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 24||2.0|-2.2|0.919
73803101|NCT00708552|147155820|SUPERIORITY||Mean Difference (Net)|-0.1||||0.896|TWO_SIDED|95.0|-2.3|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 24||2.0|-2.3|0.896
73803102|NCT00708552|147155821|SUPERIORITY||Mean Difference (Net)|-0.2||||0.594|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.9|0.594
73803103|NCT00708552|147155821|SUPERIORITY||Mean Difference (Net)|0.2||||0.523|TWO_SIDED|95.0|-0.5|0.9|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-35mg at Week 24||0.9|-0.5|0.523
73803104|NCT00708552|147155821|SUPERIORITY||Mean Difference (Net)|0.3||||0.429|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||CSDD Total score, Placebo Vs Donepezil at Week 24||1.0|-0.4|0.429
73803105|NCT00708552|147155822|SUPERIORITY||Mean Difference (Net)|0.0||||0.966|TWO_SIDED|95.0|-0.8|0.8|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-15mg at Week 24||0.8|-0.8|0.966
73803106|NCT00708552|147155822|SUPERIORITY||Mean Difference (Net)|0.3||||0.505|TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-35mg at Week 24||1.1|-0.5|0.505
73803107|NCT00708552|147155822|SUPERIORITY||Mean Difference (Net)|0.8||||0.044|TWO_SIDED|95.0|0.0|1.6|||ANCOVA|||MMSE Total score, Placebo Vs Donepezil at Week 24||1.6|0.0|0.044
73803108|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.0||||0.869|TWO_SIDED|95.0|-0.5|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 12||0.5|-0.5|0.869
73803109|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.2||||0.5|TWO_SIDED|95.0|-0.4|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 12||0.8|-0.4|0.500
73803110|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.3||||0.14|TWO_SIDED|95.0|-0.1|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 12||0.8|-0.1|0.140
73803111|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.0||||0.91|TWO_SIDED|95.0|-0.6|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.6|0.910
73803112|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.1||||0.774|TWO_SIDED|95.0|-0.5|0.7|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 24||0.7|-0.5|0.774
73803113|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|-0.1||||0.726|TWO_SIDED|95.0|-0.7|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 24||0.5|-0.7|0.726
73803114|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|-0.8||||0.292|TWO_SIDED|95.0|-2.2|0.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 12||0.7|-2.2|0.292
73803115|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.0||||0.946|TWO_SIDED|95.0|-1.3|1.4|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.3|0.946
73803116|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.2||||0.802|TWO_SIDED|95.0|-1.3|1.6|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 12||1.6|-1.3|0.802
73803117|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|-0.4||||0.636|TWO_SIDED|95.0|-2.1|1.3|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 24||1.3|-2.1|0.636
73803118|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|-0.3||||0.752|TWO_SIDED|95.0|-2.0|1.5|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 24||1.5|-2.0|0.752
73803119|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|-0.1||||0.92|TWO_SIDED|95.0|-1.9|1.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 24||1.7|-1.9|0.920
73803120|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.0||||0.972|TWO_SIDED|95.0|-0.7|0.6|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 12||0.6|-0.7|0.972
73803121|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.3||||0.378|TWO_SIDED|95.0|-0.4|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 12||0.9|-0.4|0.378
73803122|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.3||||0.346|TWO_SIDED|95.0|-0.3|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 12||0.9|-0.3|0.346
73803123|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.1||||0.72|TWO_SIDED|95.0|-0.6|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 24||0.9|-0.6|0.720
73803124|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.2||||0.598|TWO_SIDED|95.0|-0.6|1.0|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 24||1.0|-0.6|0.598
73803125|NCT00708552|147155823|SUPERIORITY||Mean Difference (Net)|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.1|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 24||1.1|-0.5|0.480
73803126|NCT00455403|147155847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.01||||0.7279|TWO_SIDED|||||"Applies to row Title year 1"|Mixed Models Analysis||"applies to row title year 1"|||||0.7279
73803127|NCT00502242|147155936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.228||||0.0002|TWO_SIDED|95.0|0.099|0.528||2-sided p-value; alpha equals (=) 0.05|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata|||0.528|0.099|0.0002
73895286|NCT00146848|147323604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|STANDARD_ERROR_OF_MEAN|1.87||0.43|TWO_SIDED|95.0|-2.18|5.16|||t-test, 2 sided|||The difference in changes in quality of life between groups were compared using a t-test.||5.16|-2.18|0.43
73895287|NCT00146848|147323605|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Cochran-Armitage test for trend|||One sided test testing for shift towards improvement in either atrial support pacing treatment arm compared to the DDD-40 arm.||||0.55
73895288|NCT00146848|147323605|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Cochran-Armitage test for trend|||||||0.80
73895289|NCT00146848|147323606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.17|STANDARD_ERROR_OF_MEAN|6.35||0.11|TWO_SIDED|95.0|-22.65|2.3|||t-test, 2 sided|||Compare the difference in the changes in physical activity scores between groups using a t-test.||2.30|-22.65|0.11
73895290|NCT00146848|147323606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|STANDARD_ERROR_OF_MEAN|6.55||0.04|TWO_SIDED|95.0|-26.11|-0.37|||t-test, 2 sided|||"Compare the difference in the changes in physical activity scores between groups using a t-test.~To adjust for multiple comparisons, an alpha level of 0.025 should be used to deem significance."||-0.37|-26.11|0.04
73895291|NCT00119678|147323610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.7|1.5|||||Cox proportional-hazards model was used to estimate the hazard ratio of abatacept versus placebo for SLE disease flare. The 95% two-sided confidence interval was provided for the hazard ratio for treatment.|||1.5|0.7|
73895292|NCT00509145|147323647|SUPERIORITY||Risk Ratio (RR)|0.77|STANDARD_ERROR_OF_MEAN|0.066||0.0024|TWO_SIDED|95.0|0.65|0.911|||Over-dispersed Poisson Regression||Laquinimod 0.6 mg vs. placebo|Response variable: number of relapses during 24 months. Offset based on the log of subject's exposure in years was employed to adjust for variability of treatment exposure. In addition to the treatment group, the Poisson regression model included the following covariates: baseline EDSS score, log of prior 2-year number of relapses+1 and Country or Geographical Region (CGR).||0.911|0.650|0.0024
73895293|NCT00750152|147323652|SUPERIORITY_OR_OTHER||one-sided p-value from CMH test|0.001||||0.025|ONE_SIDED|95.0|||||Cochran-Mantel-Haenszel|The CMH test after stratification by site compared the proportion of complete cure in NAFT-500 to that of placebo to evaluate its superiority.||"In order to compare complete cure rate in the NAFT-500 group with that in the placebo group, the following one-sided null and alternate hypotheses will be tested:~* H0: p1 \<= p0~* Ha: p1 \> p0 where p0 and p1 denote the proportion of subjects with complete cure in the placebo and NAFT-500 groups, respectively."||||0.025
73803128|NCT00502242|147155937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425||||0.0031|TWO_SIDED|95.0|0.237|0.763||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata|||0.763|0.237|0.0031
73803129|NCT00502242|147155938|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.002
73803130|NCT00502242|147155938|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.074
73803131|NCT00502242|147155939|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.093
73895294|NCT02140593|147323666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73895295|NCT02140593|147323667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73895296|NCT02034409|147323694|NON_INFERIORITY|For the 48-week OMERACT-OARSI response the minimally clinically significant difference is an absolute rate difference of 10% between sham and PLIUS groups. With a total sample size of 144 the probability of correctly selecting the group with the greatest OORR is at least 0.885 assuming (δ=10%) that the sham group is drawn from a population with a 50% response rate and the PLIUS group is drawn from a population with response rate of at least 60% or at most 40%.||||||||||||||||Sample size has been calculated with ranking and selection methodology, a procedure used for Phase II trials. The purpose of the procedure as applied to this study is to identify whether PLIUS has a high probability of being more effective than sham. This is accomplished by obtaining sample estimates of the outcome for the PLIUS and sham groups and determining whether the PLIUS group outcome is better by the pre-specified margin of difference.|Since the ranking and selection procedures are fundamentally different from traditional hypothesis testing, concepts of statistical significance and power have no direct analogue.|||
73895297|NCT02034409|147323695|NON_INFERIORITY|For the 48-week cartilage change outcome measure the minimally clinically significant difference is 33 μm. With a difference of 33 μm, σ=152 μm standard deviation, k=2 groups, and P=0.90 probability to obtain τ=1.8124, which we use to estimate the per-group sample size: n=σ2(τ/δ\*)2=72 or a total of 144.||||||||||||||||Sample size has been calculated with ranking and selection methodology, a procedure used for Phase II trials. The purpose of the procedure as applied to this study is to identify whether PLIUS has a high probability of being more effective than sham. This is accomplished by obtaining sample estimates of the outcome for the PLIUS and sham groups and determining whether the PLIUS group outcome is better by the pre-specified margin of difference.|Since the ranking and selection procedures are fundamentally different from traditional hypothesis testing, concepts of statistical significance and power have no direct analogue.|||
73803132|NCT00502242|147155939|SUPERIORITY_OR_OTHER|||||||0.219|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.219
73803133|NCT00502242|147155940|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.002
73803134|NCT00502242|147155940|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.121
73803135|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.16|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril||||
73803136|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.36|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo||||
73803137|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Treatment Ratio|0.85||||0.0098|TWO_SIDED|95.0|0.76|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 3, Ramipril versus (vs.) Placebo||0.96|0.76|0.0098
73803138|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.18|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 4, Ramipril||||
73803139|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.52|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 4, Placebo||||
73803140|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Treatment Ratio|0.78||||0.0003|TWO_SIDED|95.0|0.68|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 4, Ramipril vs. Placebo||0.89|0.68|0.0003
73803141|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.27|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 8, Ramipirl||||
73803142|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.61|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 8, Placebo||||
73803143|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Treatment Ratio|0.79||||0.0016|TWO_SIDED|95.0|0.68|0.91||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo||0.91|0.68|0.0016
73803144|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.34|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril||||
73803145|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.63|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo||||
73803146|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Treatment Ratio|0.82||||0.0165|TWO_SIDED|95.0|0.7|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo||0.96|0.70|0.0165
73803147|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.48|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril||||
73803148|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.78|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo||||
73803149|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Treatment Ratio|0.83||||0.0264|TWO_SIDED|95.0|0.7|0.98||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo||0.98|0.70|0.0264
73803150|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.43|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril||||
73803151|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.82|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo||||
73803152|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Treatment Ratio|0.79||||0.0062|TWO_SIDED|95.0|0.66|0.93||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo||0.93|0.66|0.0062
73803153|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.4|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril||||
73803154|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.67|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo||||
73803155|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.0341|TWO_SIDED|95.0|0.72|0.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo||0.99|0.72|0.0341
73803156|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.56|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril||||
73803157|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.86|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo||||
73803158|NCT00502242|147155941|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.06|TWO_SIDED|95.0|0.7|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo||1.01|0.70|0.0600
73803159|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.46|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril||||
73803160|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.05|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo||||
73803161|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Treatment Ratio|0.71||||0.0034|TWO_SIDED|95.0|0.57|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 3, Ramipril vs. Placebo||0.89|0.57|0.0034
73803162|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.43|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 4, Ramipril||||
73803163|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.37|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 4, Placebo||||
73803164|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Treatment Ratio|0.6|||<|0.0001|TWO_SIDED|95.0|0.47|0.76||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 4, Ramipril vs. Placebo||0.76|0.47|<0.0001
73803165|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.67|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 8, Ramipril||||
73803166|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.74|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 8, Placebo||||
73803167|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Treatment Ratio|0.61||||0.0002|TWO_SIDED|95.0|0.47|0.79||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo||0.79|0.47|0.0002
73803168|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.91|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril||||
73803169|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.92|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo||||
73803170|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Treatment Ratio|0.65||||0.0032|TWO_SIDED|95.0|0.49|0.87||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo||0.87|0.49|0.0032
73803171|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.33|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril||||
73803172|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.39|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo||||
73803173|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Treatment Ratio|0.69||||0.013|TWO_SIDED|95.0|0.51|0.92||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo||0.92|0.51|0.0130
73803174|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.5|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril||||
73803175|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.39|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo||||
73803176|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Treatment Ratio|0.74||||0.0577|TWO_SIDED|95.0|0.54|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo||1.01|0.54|0.0577
73803177|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.52|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril||||
73803178|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.27|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo||||
73803179|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Treatment Ratio|0.77||||0.1146|TWO_SIDED|95.0|0.56|1.07||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo||1.07|0.56|0.1146
73803180|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.92|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril||||
73803181|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.45|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo||||
73803182|NCT00502242|147155942|SUPERIORITY_OR_OTHER||Treatment Ratio|0.85||||0.3496|TWO_SIDED|95.0|0.6|1.2||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo||1.20|0.60|0.3496
73803183|NCT00502242|147155943|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||1.0000
73803184|NCT00502242|147155943|SUPERIORITY_OR_OTHER|||||||0.1115|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.1115
73803185|NCT00502242|147155944|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|1.26||0.4933|TWO_SIDED|95.0|-3.33|1.61||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 12||1.61|-3.33|0.4933
73803186|NCT00502242|147155944|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|2.48|STANDARD_ERROR_OF_MEAN|1.45||0.0888|TWO_SIDED|95.0|-0.38|5.33||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 24||5.33|-0.38|0.0888
73803187|NCT00502242|147155944|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|2.12|STANDARD_ERROR_OF_MEAN|1.46||0.1475|TWO_SIDED|95.0|-0.75|4.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate|Adjusted for baseline|Change from Baseline at Week 52||4.99|-0.75|0.1475
73803188|NCT00502242|147155945|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.1167|TWO_SIDED|95.0|0.68|1.04||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 24||1.04|0.68|0.1167
73803189|NCT00502242|147155945|SUPERIORITY_OR_OTHER||Treatment Ratio|1.04||||0.7519|TWO_SIDED|95.0|0.82|1.31||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 52||1.31|0.82|0.7519
73803190|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low DBP ≤50 mmHg||||0.470
73803191|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High DBP ≥110 mmHg||||0.220
73803192|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low SBP: ≤90 mmHg||||0.470
73803193|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High SBP: ≥180 mmHg||||1.000
73803194|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||0.725|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low DBP ≤50 mmHg||||0.725
73803195|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High DBP ≥110 mmHg||||0.227
73803196|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low SBP: ≤90 mmHg||||1.000
73803197|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High SBP: ≥180 mmHg||||0.106
73895298|NCT00006289|147323710|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B, without knowing which drug is Neurotropin or Placebo) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
73803198|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, High DBP ≥110 mmHg||||1.000
73803199|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, Low SBP: ≤90 mmHg||||1.000
73803200|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low DBP ≤50 mmHg||||0.475
73803201|NCT00502242|147155946|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low SBP: ≤90 mmHg||||0.475
73803202|NCT00502242|147155948|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||1.000
73803203|NCT00502242|147155948|SUPERIORITY_OR_OTHER|||||||0.626|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.626
73803204|NCT00502242|147155948|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.297
73803205|NCT00502242|147155948|SUPERIORITY_OR_OTHER|||||||0.356|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.356
73803206|NCT00502242|147155949|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.064
73803207|NCT00502242|147155949|SUPERIORITY_OR_OTHER|||||||0.069|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.069
73895299|NCT00006289|147323711|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
73803208|NCT00502242|147155949|SUPERIORITY_OR_OTHER|||||||0.752|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.752
73803209|NCT00502242|147155949|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.261
73803210|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.09|STANDARD_ERROR_OF_MEAN|0.1||0.381|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 4||||0.381
73803211|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.956|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 12||||0.956
73803212|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.903|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 24||||0.903
73803213|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.503|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 52||||0.503
73803214|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.451|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 4||||0.451
73803215|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.919|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 12||||0.919
73803216|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.637|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 24||||0.637
73803217|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.229|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 52||||0.229
73803218|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.766|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 4||||0.766
73803219|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.14|STANDARD_ERROR_OF_MEAN|0.11||0.217|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 12||||0.217
73803220|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.457|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 24||||0.457
73803221|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.26|STANDARD_ERROR_OF_MEAN|0.13||0.041|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 52||||0.041
73803222|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.25|STANDARD_ERROR_OF_MEAN|0.12||0.044|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 4||||0.044
73803223|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.18|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 12||||0.180
73803224|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.264|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 24||||0.264
73803225|NCT00502242|147155950|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.408|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 52||||0.408
73803226|NCT00502242|147155951|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.487||||0.0732|TWO_SIDED|95.0|0.887|6.978||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank||Hazard ratio was based on the Cox proportional hazards model.|||6.978|0.887|0.0732
73803227|NCT00502242|147155953|SUPERIORITY_OR_OTHER|||||||0.7165|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL, AM BCAR||||0.7165
73803228|NCT00502242|147155953|SUPERIORITY_OR_OTHER|||||||0.4795|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL (On-Therapy), AM BCAR||||0.4795
73803229|NCT00502242|147155954|SUPERIORITY_OR_OTHER|||||||0.4773|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Week 52||||0.4773
73803230|NCT00502242|147155955|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.124
73803231|NCT00502242|147155955|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.410
73803232|NCT00502242|147155955|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.423
73803233|NCT00502242|147155955|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.297
73803234|NCT00502242|147155956|SUPERIORITY_OR_OTHER|||||||0.726|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||0.726
73803235|NCT00502242|147155957|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||1.000
73803236|NCT00502242|147155958|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||0.753
73803237|NCT00502242|147155959|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.224
73803238|NCT00502242|147155959|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.179
73803239|NCT00502242|147155959|SUPERIORITY_OR_OTHER|||||||0.604|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.604
73803240|NCT00502242|147155959|SUPERIORITY_OR_OTHER|||||||0.486|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.486
73803241|NCT04630002|147155982|OTHER||Ratio of geometric least square means|1.137|||||TWO_SIDED|90.0|0.999|1.293|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.293|0.9990|
73803242|NCT04630002|147155983|OTHER||Ratio of geometric least square means|1.068|||||TWO_SIDED|90.0|0.9185|1.242|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.242|0.9185|
73803243|NCT04630002|147155984|OTHER||Ratio of geometric least square means|0.9891|||||TWO_SIDED|90.0|0.9313|1.051|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.051|0.9313|
73803244|NCT04630002|147155985|OTHER||Ratio of geometric least square means|1.05|||||TWO_SIDED|90.0|0.9816|1.122|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.122|0.9816|
73803245|NCT04630002|147155986|OTHER||Ratio of geometric least square means|1.102|||||TWO_SIDED|90.0|1.025|1.185|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.185|1.025|
73803246|NCT04630002|147155987|OTHER||Ratio of geometric least square means|1.12|||||TWO_SIDED|90.0|0.9947|1.26|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.260|0.9947|
73803247|NCT04630002|147155988|OTHER||Ratio of geometric least square means|0.5299|||||TWO_SIDED|90.0|0.4801|0.5848|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||0.5848|0.4801|
73803248|NCT04630002|147155989|OTHER||Ratio of geometric least square means|0.6001|||||TWO_SIDED|90.0|0.5271|0.6833|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||0.6833|0.5271|
73803249|NCT04630002|147155990|OTHER||Ratio of geometric least square means|1.144|||||TWO_SIDED|90.0|1.082|1.21|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.210|1.082|
73803250|NCT04630002|147155991|OTHER||Ratio of geometric least square means|1.104|||||TWO_SIDED|90.0|1.026|1.187|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.187|1.026|
73803251|NCT04630002|147155992|OTHER||Ratio of geometric least square means|0.9435|||||TWO_SIDED|90.0|0.8147|1.093|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.093|0.8147|
73803252|NCT04630002|147155993|OTHER||Ratio of geometric least square means|0.8928|||||TWO_SIDED|90.0|0.7467|1.068|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.068|0.7467|
73803253|NCT00442897|147156050|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.714||||||95.0|1.77|7.78|||||Odds ratio was adjusted by baseline LDL strata.|||7.78|1.77|
73803254|NCT00442897|147156051|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.579||||||95.0|1.32|5.06|||||Odds ratio was adjusted by baseline LDL strata.|||5.06|1.32|
73803255|NCT04498182|147156052|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.81||0.2305|TWO_SIDED|95.0|-8.9|2.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.2|-8.9|0.2305
73803256|NCT04498182|147156052|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.81||0.7436|TWO_SIDED|95.0|-4.6|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-4.6|0.7436
73803257|NCT04498182|147156053|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4936|TWO_SIDED|95.0|-1.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-1.9|0.4936
73803258|NCT04498182|147156053|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.7131|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.6|-1.1|0.7131
73803259|NCT04498182|147156054|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.81||0.2305|TWO_SIDED|95.0|-8.9|2.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.2|-8.9|0.2305
73803260|NCT04498182|147156054|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.81||0.7436|TWO_SIDED|95.0|-4.6|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-4.6|0.7436
73803261|NCT04498182|147156055|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.17||0.0281|TWO_SIDED|95.0|-13.2|-0.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.8|-13.2|0.0281
73803262|NCT04498182|147156055|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|3.18||0.9186|TWO_SIDED|95.0|-5.9|6.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.6|-5.9|0.9186
73803263|NCT04498182|147156056|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.17||0.0281|TWO_SIDED|95.0|-13.2|-0.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.8|-13.2|0.0281
73803264|NCT04498182|147156056|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|3.18||0.9186|TWO_SIDED|95.0|-5.9|6.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.6|-5.9|0.9186
73803265|NCT04498182|147156057|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.75||0.9846|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.5|-1.5|0.9846
73803266|NCT04498182|147156057|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6508|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.8|-1.1|0.6508
73803267|NCT04498182|147156058|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.75||0.9846|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.5|-1.5|0.9846
73803268|NCT04498182|147156058|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6508|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.8|-1.1|0.6508
73803269|NCT04498182|147156059|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4936|TWO_SIDED|95.0|-1.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-1.9|0.4936
73803270|NCT04498182|147156059|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.7131|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.6|-1.1|0.7131
73803271|NCT04498182|147156060|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.38||0.0786|TWO_SIDED|95.0|-12.6|0.7|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.7|-12.6|0.0786
73803272|NCT04498182|147156060|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.39||0.9477|TWO_SIDED|95.0|-6.9|6.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.5|-6.9|0.9477
73803273|NCT04498182|147156061|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.38||0.0786|TWO_SIDED|95.0|-12.6|0.7|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.7|-12.6|0.0786
73803274|NCT04498182|147156061|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.39||0.9477|TWO_SIDED|95.0|-6.9|6.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.5|-6.9|0.9477
73803275|NCT04498182|147156062|SUPERIORITY||LS Means Difference|-5.0|STANDARD_ERROR_OF_MEAN|3.16||0.1153|TWO_SIDED|95.0|-11.2|1.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.2|-11.2|0.1153
73803276|NCT04498182|147156062|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|3.15||0.9975|TWO_SIDED|95.0|-6.2|6.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.2|-6.2|0.9975
73803277|NCT04498182|147156063|SUPERIORITY||LS Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|3.16||0.1153|TWO_SIDED|95.0|-11.2|1.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.2|-11.2|0.1153
73803278|NCT04498182|147156063|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|3.15||0.9975|TWO_SIDED|95.0|-6.2|6.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.2|-6.2|0.9975
73803279|NCT04498182|147156064|SUPERIORITY||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|3.82||0.1518|TWO_SIDED|95.0|-13.0|2.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.0|-13.0|0.1518
73803280|NCT04498182|147156064|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.87||0.407|TWO_SIDED|95.0|-4.4|10.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||10.8|-4.4|0.4070
73803281|NCT04498182|147156065|SUPERIORITY||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|3.82||0.1518|TWO_SIDED|95.0|-13.0|2.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.0|-13.0|0.1518
73803282|NCT04498182|147156065|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.87||0.407|TWO_SIDED|95.0|-4.4|10.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||10.8|-4.4|0.4070
73803283|NCT04498182|147156066|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.56||0.756|TWO_SIDED|95.0|-8.1|5.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.9|-8.1|0.7560
73803284|NCT04498182|147156066|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.62||0.8308|TWO_SIDED|95.0|-7.9|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-7.9|0.8308
73803285|NCT04498182|147156067|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.56||0.756|TWO_SIDED|95.0|-8.1|5.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.9|-8.1|0.7560
73803286|NCT04498182|147156067|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.62||0.8308|TWO_SIDED|95.0|-7.9|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-7.9|0.8308
73803287|NCT04498182|147156068|SUPERIORITY||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.26||0.0005|TWO_SIDED|95.0|-12.4|-3.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.5|-12.4|0.0005
73803288|NCT04498182|147156068|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|2.26||0.0585|TWO_SIDED|95.0|-8.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.2|-8.7|0.0585
73803289|NCT04498182|147156069|SUPERIORITY||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.26||0.0005|TWO_SIDED|95.0|-12.4|-3.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.5|-12.4|0.0005
73803290|NCT04498182|147156069|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|2.26||0.0585|TWO_SIDED|95.0|-8.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.2|-8.7|0.0585
73803291|NCT04498182|147156070|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|2.77||0.0015|TWO_SIDED|95.0|-14.3|-3.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.4|-14.3|0.0015
73803292|NCT04498182|147156070|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.6812|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.3|-6.6|0.6812
73803293|NCT04498182|147156071|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|2.77||0.0015|TWO_SIDED|95.0|-14.3|-3.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.4|-14.3|0.0015
73803294|NCT04498182|147156071|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.6812|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.3|-6.6|0.6812
73803295|NCT04498182|147156072|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.5||0.152|TWO_SIDED|95.0|-8.5|1.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.3|-8.5|0.1520
73803296|NCT04498182|147156072|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.49||0.8515|TWO_SIDED|95.0|-5.4|4.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.4|-5.4|0.8515
73803297|NCT04498182|147156073|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.5||0.152|TWO_SIDED|95.0|-8.5|1.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.3|-8.5|0.1520
73803298|NCT04498182|147156073|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.49||0.8515|TWO_SIDED|95.0|-5.4|4.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.4|-5.4|0.8515
73803299|NCT04498182|147156074|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0302|TWO_SIDED|95.0|-12.1|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-12.1|0.0302
73803300|NCT04498182|147156074|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.92||0.8013|TWO_SIDED|95.0|-6.5|5.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.0|-6.5|0.8013
73803301|NCT04498182|147156075|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0302|TWO_SIDED|95.0|-12.1|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-12.1|0.0302
73803302|NCT04498182|147156075|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.92||0.8013|TWO_SIDED|95.0|-6.5|5.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.0|-6.5|0.8013
73803303|NCT04498182|147156076|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.52||0.8166|TWO_SIDED|95.0|-4.4|5.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.5|-4.4|0.8166
73803304|NCT04498182|147156076|SUPERIORITY||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.52||0.3371|TWO_SIDED|95.0|-2.5|7.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.4|-2.5|0.3371
73803305|NCT04498182|147156077|SUPERIORITY|||||||0.3365|||||||Wilcoxon (Mann-Whitney)|||||||0.3365
73803306|NCT04498182|147156077|SUPERIORITY|||||||0.7323|||||||Wilcoxon (Mann-Whitney)|||||||0.7323
73803307|NCT04498182|147156078|SUPERIORITY|||||||0.1557|||||||Wilcoxon (Mann-Whitney)|||||||0.1557
73803308|NCT04498182|147156078|SUPERIORITY|||||||0.6845|||||||Wilcoxon (Mann-Whitney)|||||||0.6845
73803309|NCT04498182|147156079|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.52||0.8166|TWO_SIDED|95.0|-4.4|5.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.5|-4.4|0.8166
73803310|NCT04498182|147156079|SUPERIORITY|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.52||0.3371|TWO_SIDED|95.0|-2.5|7.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.4|-2.5|0.3371
73803311|NCT04498182|147156080|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.81||0.5215|TWO_SIDED|95.0|-3.7|7.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.3|-3.7|0.5215
73803312|NCT04498182|147156080|SUPERIORITY||LS Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|2.81||0.1312|TWO_SIDED|95.0|-1.3|9.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||9.8|-1.3|0.1312
73895300|NCT00006289|147323712|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
73895301|NCT02043808|147323715|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.92|0.52|
73803313|NCT04498182|147156081|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.81||0.5215|TWO_SIDED|95.0|-3.7|7.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.3|-3.7|0.5215
73803314|NCT04498182|147156081|SUPERIORITY||LS Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|2.81||0.1312|TWO_SIDED|95.0|-1.3|9.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||9.8|-1.3|0.1312
73803315|NCT04498182|147156082|SUPERIORITY||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.99||0.0254|TWO_SIDED|95.0|-8.4|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-8.4|0.0254
73803316|NCT04498182|147156082|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.99||0.1362|TWO_SIDED|95.0|-6.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-6.9|0.1362
73803317|NCT04498182|147156083|SUPERIORITY||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.99||0.0254|TWO_SIDED|95.0|-8.4|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-8.4|0.0254
73803318|NCT04498182|147156083|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.99||0.1362|TWO_SIDED|95.0|-6.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-6.9|0.1362
73803319|NCT04498182|147156084|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.06||0.0573|TWO_SIDED|95.0|-8.0|0.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.1|-8.0|0.0573
73803320|NCT04498182|147156084|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.06||0.993|TWO_SIDED|95.0|-4.0|4.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.1|-4.0|0.9930
73803321|NCT04498182|147156085|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.06||0.0573|TWO_SIDED|95.0|-8.0|0.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.1|-8.0|0.0573
73803322|NCT04498182|147156085|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.06||0.993|TWO_SIDED|95.0|-4.0|4.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.1|-4.0|0.9930
73803323|NCT04498182|147156086|SUPERIORITY||Odds Ratio (OR)|1.48||||0.3068|TWO_SIDED|95.0|0.7|3.15|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.15|0.70|0.3068
73803324|NCT04498182|147156086|SUPERIORITY||Odds Ratio (OR)|1.22||||0.6167|TWO_SIDED|95.0|0.56|2.68|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||2.68|0.56|0.6167
73803325|NCT04498182|147156087|SUPERIORITY||Odds Ratio (OR)|0.64||||0.2867|TWO_SIDED|95.0|0.28|1.46|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.46|0.28|0.2867
73803326|NCT04498182|147156087|SUPERIORITY||Odds Ratio (OR)|0.7||||0.3803|TWO_SIDED|95.0|0.32|1.57|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.57|0.32|0.3803
73803327|NCT04498182|147156088|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4375|TWO_SIDED|95.0|0.58|3.58|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.58|0.58|0.4375
73803328|NCT04498182|147156088|SUPERIORITY||Odds Ratio (OR)|1.3||||0.584|TWO_SIDED|95.0|0.51|3.27|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.27|0.51|0.5840
73803329|NCT04498182|147156089|SUPERIORITY||Odds Ratio (OR)|0.73||||0.5046|TWO_SIDED|95.0|0.29|1.84|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.84|0.29|0.5046
73803330|NCT04498182|147156089|SUPERIORITY||Odds Ratio (OR)|1.27||||0.5751|TWO_SIDED|95.0|0.56|2.88|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||2.88|0.56|0.5751
73895302|NCT02043808|147323716|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.83|||||TWO_SIDED|95.0|0.71|0.98|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.98|0.71|
73803331|NCT02104219|147156090|SUPERIORITY_OR_OTHER|||||||0.0755|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median RGI-C score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Pairs of radiographs were centrally evaluated by 3 independent, blinded pediatric radiologists trained in the assessment of the skeletal manifestations of HPP. The mean RGI-C score across the 3 radiologists was calculated and served as the patient's RGI-C score for a specific time point||||0.0755
73895303|NCT02043808|147323717|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.79|||||TWO_SIDED|95.0|0.59|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.07|0.59|
73895304|NCT02043808|147323718|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.31|||||TWO_SIDED|95.0|0.13|0.7|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.70|0.13|
73895305|NCT02043808|147323719|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.48|||||TWO_SIDED|95.0|0.3|0.77|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.77|0.30|
73895306|NCT02043808|147323720|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.9|||||TWO_SIDED|95.0|0.76|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.07|0.76|
73895307|NCT02043808|147323721|SUPERIORITY_OR_OTHER||Crude event rate ratio|1.07|||||TWO_SIDED|95.0|0.89|1.3|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.30|0.89|
73895308|NCT02043808|147323722|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.72|||||TWO_SIDED|95.0|0.5|1.03|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.03|0.50|
73895309|NCT02043808|147323723|SUPERIORITY_OR_OTHER||Crude event rate ratio|1.24|||||TWO_SIDED|95.0|0.99|1.54|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.54|0.99|
73895310|NCT02043808|147323724|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.35|||||TWO_SIDED|95.0|0.17|0.72|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.72|0.17|
73895311|NCT02043808|147323725|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.37|||||TWO_SIDED|95.0|0.22|0.64|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.64|0.22|
73895312|NCT02043808|147323726|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.83|||||TWO_SIDED|95.0|0.55|1.26|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.26|0.55|
73895313|NCT02043808|147323727|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.66|||||TWO_SIDED|95.0|0.45|0.95|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.95|0.45|
73895314|NCT02043808|147323728|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.64|||||TWO_SIDED|95.0|0.31|1.31|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.31|0.31|
73895315|NCT02043808|147323729|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.44|||||TWO_SIDED|95.0|0.16|1.21|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.21|0.16|
73803332|NCT02104219|147156091|SUPERIORITY_OR_OTHER|||||||0.6344|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median change in height Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented height measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline height. Height measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in height Z-score from Baseline were computed by subtracting baseline height Z-score from post baseline height Z-scores. The post baseline time points were grouped by time intervals.||||0.6344
73895316|NCT02043808|147323730|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.97|||||TWO_SIDED|95.0|0.34|2.81|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||2.81|0.34|
73895317|NCT02043808|147323731|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.69|0.52|
73895318|NCT03703297|147323732|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.01608|TWO_SIDED|95.0|0.606|0.95|||Log Rank|The analysis was performed using the stratified log-rank test.|Hazard ratio and CI calculated using stratified Cox proportional hazards model,adjusting for tumor,node and metastasis(TNM) stage, receipt of prophylactic cranial irradiation(PCI),with treatment as only covariate and ties handled by Efron approach.|||0.950|0.606|0.01608
73895319|NCT03703297|147323733|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.01042|TWO_SIDED|95.0|0.569|0.928|||Log Rank|The analysis was performed using the stratified log-rank test.|Hazard ratio and CI were calculated using stratified Cox proportional hazards model, adjusting for receipt of PCI, with treatment as only covariate and ties handled by Efron approach.|||0.928|0.569|0.01042
73895320|NCT02617485|147323932|EQUIVALENCE|Equivalence met if the 90% CI of the Geo LS Means ratio is contained with the pre-specified equivalence margin of 70% - 143%.|Ratio of Geo LS-means|1.0406|||||TWO_SIDED|90.0|0.9565|1.1321||||||Estimated Geo LS-means ratio.||1.1321|0.9565|
73895321|NCT02617485|147323933|EQUIVALENCE|Equivalence met if the 90% CI of the Geo LS Means ratio is contained with the pre-specified equivalence margin of 70% - 143%.|Ratio of Geo LS-means|1.0611|||||TWO_SIDED|90.0|0.9822|1.1464||||||Estimated Geo LS-means ratio.||1.1464|0.9822|
73895322|NCT04250077|147324077|SUPERIORITY||proportion|0.36923076|STANDARD_ERROR_OF_MEAN|0.16518156||0.02578184|TWO_SIDED|95.0|-0.0021812|0.64531855|||Agresti Caffo proportion comparison|||||0.64531855|-0.0021812|0.02578184
73895323|NCT04250077|147324078|SUPERIORITY||Mean Difference (Net)|20.0454545|STANDARD_ERROR_OF_MEAN|7.62386242||0.00787297|TWO_SIDED|95.0|4.18213496|35.9087741|||t-test, 1 sided|||||35.9087741|4.18213496|0.00787297
73895324|NCT04250077|147324079|SUPERIORITY||Mean Difference (Net)|-39.183333|STANDARD_ERROR_OF_MEAN|15.8274398||0.01387108|TWO_SIDED|95.0|-73.356073|-5.0105927|||t-test, 1 sided|||||-5.0105927|-73.356073|0.01387108
73895325|NCT04250077|147324080|SUPERIORITY||Mean Difference (Net)|8.43728901|STANDARD_ERROR_OF_MEAN|3.28323704||0.00908118|TWO_SIDED|95.0|1.59437702|15.280201|||t-test, 1 sided|||||15.2802010|1.59437702|0.00908118
73895326|NCT04250077|147324081|SUPERIORITY||Mean Difference (Net)|1.47698833|STANDARD_ERROR_OF_MEAN|3.68529034||0.34633293|TWO_SIDED|95.0|-6.1910435|9.14502026|||t-test, 1 sided|||||9.14502026|-6.1910435|0.34633293
73895327|NCT04250077|147324082|SUPERIORITY||Mean Difference (Final Values)|-0.4285714|STANDARD_ERROR_OF_MEAN|2.07315199||0.57872623|TWO_SIDED|95.0|-5.4078121|4.55066924|||t-test, 1 sided|||||4.55066924|-5.4078121|0.57872623
73895328|NCT04250077|147324083|SUPERIORITY||Median Difference (Net)|1.29230769|STANDARD_ERROR_OF_MEAN|0.81588207||0.06283641|TWO_SIDED|95.0|-0.3873203|2.97193574|||t-test, 1 sided|||||2.97193574|-0.3873203|0.06283641
73895329|NCT04250077|147324084|SUPERIORITY||proportion|0.11794871|STANDARD_ERROR_OF_MEAN|0.16796576||0.26422281|TWO_SIDED|95.0|-0.2233244|0.43508919|||Agresti Caffo proportion comparison|||||0.43508919|-0.2233244|0.26422281
73895330|NCT02937584|147324120|OTHER||Geometric mean ratio to baseline|1.11||||0.0187|TWO_SIDED|95.0|1.02|1.22||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||1.22|1.02|0.0187
73895331|NCT02937584|147324120|OTHER||Geometric mean ratio to baseline|1.23|||<|0.0001|TWO_SIDED|95.0|1.14|1.33||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||1.33|1.14|<0.0001
73895332|NCT02937584|147324121|OTHER||Geometric mean ratio to baseline|0.75||||0.0219|TWO_SIDED|95.0|0.59|0.95||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.95|0.59|0.0219
73895333|NCT02937584|147324121|OTHER||Geometric mean ratio to baseline|0.56|||<|0.0001|TWO_SIDED|95.0|0.44|0.71||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.71|0.44|<0.0001
73895334|NCT02937584|147324122|OTHER||Geometric mean ratio to baseline|1.12||||0.0283|TWO_SIDED|95.0|1.01|1.24|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.24|1.01|0.0283
73895335|NCT02937584|147324122|OTHER||Geometric mean ratio to baseline|1.21|||<|0.0001|TWO_SIDED|95.0|1.12|1.31|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.31|1.12|<0.0001
73895336|NCT02937584|147324123|OTHER||Geometric mean ratio to baseline|0.76||||0.0304|TWO_SIDED|95.0|0.59|0.97|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.97|0.59|0.0304
73895337|NCT02937584|147324123|OTHER||Geometric mean ratio to baseline|0.55||||0.0003|TWO_SIDED|95.0|0.41|0.72|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.72|0.41|0.0003
73895338|NCT02937584|147324124|OTHER||Mean Change from Baseline|0.065||||0.1582|TWO_SIDED|95.0|-0.028|0.158|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.158|-0.028|0.1582
73895339|NCT02937584|147324124|OTHER||Mean Change from Baseline|0.151||||0.0375|TWO_SIDED|95.0|0.01|0.292|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.292|0.010|0.0375
73895340|NCT02937584|147324125|OTHER||Geometric mean ratio to baseline|0.978||||0.6176|TWO_SIDED|95.0|0.891|1.073|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.073|0.891|0.6176
73895341|NCT02937584|147324125|OTHER||Geometric mean ratio to baseline|0.938||||0.2699|TWO_SIDED|95.0|0.833|1.056|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.056|0.833|0.2699
73895342|NCT04075734|147324138|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.59
73895343|NCT04075734|147324138|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.003
73895344|NCT04075734|147324139|SUPERIORITY|||||||0.03|TWO_SIDED|95.0|||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.03
73895345|NCT04075734|147324140|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.07
73895346|NCT04075734|147324141|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.2
73895347|NCT04075734|147324142|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.006
73895348|NCT04075734|147324143|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.86
73895349|NCT04075734|147324144|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.14
73895350|NCT04075734|147324145|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of intervention over time.||||||0.02
73895351|NCT04075734|147324146|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.29
73895352|NCT04075734|147324147|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.13
73895353|NCT04075734|147324148|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.14
73895354|NCT04075734|147324149|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.03
73895355|NCT04075734|147324150|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.66
73895356|NCT04075734|147324151|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.15
73895357|NCT03615040|147324153|SUPERIORITY||Incidence Rate Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.15||0.195|TWO_SIDED|95.0|0.53|1.14|||t-test, 2 sided|||A generalised linear model (assuming neg. binomial distribution) was used. The model includes the number of exacerbations during the 48 week treatment as an outcome with explanatory variables of treatment arm \& number of exacerbations in the 12 months prior to the trial (stratification factor), and log-time on trial (in weeks) as an offset. The offset, allows for different lengths of time in the trial. Only observed exacerbations were used alongside the corresponding time period in the offset.||1.14|0.53|0.195
73803333|NCT02104219|147156092|SUPERIORITY_OR_OTHER|||||||0.452|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median change in weight Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented weight measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline weight. Weight measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in weight Z-score from Baseline were computed by subtracting baseline weight Z-score from post baseline weight Z-scores. The post baseline time points were grouped by time intervals.||||0.4520
73803334|NCT02104219|147156093|SUPERIORITY_OR_OTHER|||||||0.4545|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether change from baseline in the median RSS score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The Baseline x-ray set defined for RGI-C, which was compared with its subsequent x-ray sets, was also used as the Baseline x-ray set for the RSS reading. Changes from Baseline were computed based on this baseline RSS score, and postbaseline time points were grouped by intervals of time from Baseline.||||0.4545
73803335|NCT01339260|147156132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.001|TWO_SIDED|95.0|1.16|1.87||If superiority of netupitant/palonosetron was established for the CR delayed, CR acute and then CR overall at cycle 1 were to be tested according to a hierarchical procedure;no adjustment for multiplicity was needed.The a priori threshold was 0.050|Cochran-Mantel-Haenszel||Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.|The null hypothesis was rejected if the 2 sided p value from the Cochran Mantel Haenszel test was less than or equal to 0.050 and in the right direction i.e., the Odds Ratio (OR) was in favor of netupitant/palonosetron. Power was 90%.||1.87|1.16|0.001
73803336|NCT01339260|147156133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.047|TWO_SIDED|95.0|1.0|1.87||If the null hypothesis for CR delayed was rejected, analysis of the first key secondary endpoint CR acute was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the acute phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the acute phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.||1.87|1.0|0.047
73803337|NCT01339260|147156134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.001|TWO_SIDED|95.0|1.17|1.85||If the null hypothesis for CR acute was rejected, analysis of the 2nd key secondary endpoint CR overall was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the overall phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the overall phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.||1.85|1.17|0.001
73803338|NCT03137160|147156135|SUPERIORITY|||||||1|||||||Fisher Exact|||This is the Investigator Global Assessment comparing the proportion of subjects who achieved a 2 pt reduction at study close (0).||||1
73803339|NCT03448419|147156150|SUPERIORITY||Median difference (HL-estimate)|-4.0||||0.4236|TWO_SIDED|95.0|-16.0|6.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||6.0|-16.0|0.4236
73803340|NCT03448419|147156151|SUPERIORITY||Median difference (HL-estimate)|3.13||||0.0893|TWO_SIDED|95.0|0.0|7.29|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||7.29|0.00|0.0893
73803341|NCT03448419|147156152|SUPERIORITY||Median Difference (HL-estimate)|0.1||||0.4702|TWO_SIDED|95.0|-0.2|0.4|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||0.40|-0.20|0.4702
73803342|NCT03448419|147156153|SUPERIORITY||Median difference (HL-estimate)|0.0||||0.983|TWO_SIDED|95.0|-9.0|9.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||9.0|-9.0|0.9830
73803343|NCT03448419|147156154|OTHER||Difference of adjusted means|-0.31||||0.0053|TWO_SIDED|95.0|-0.53|-0.09|||Mixed Model repeated Measures (MMRM)|Covariates: visit-by-treatment interaction, baseline-by-visit interaction. Unstructured covariance structure was used to model within-patient errors.||||-0.09|-0.53|0.0053
73803344|NCT03448419|147156155|OTHER|||||||0.6189|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.6189
73803345|NCT03448419|147156156|OTHER|||||||0.6672|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.6672
73803346|NCT03448419|147156157|OTHER|||||||0.5147|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5147
73803347|NCT03448419|147156158|OTHER|||||||0.863|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.8630
73803348|NCT03448419|147156159|OTHER||Adjusted geometric mean ratio|0.91||||0.141|TWO_SIDED|95.0|0.81|1.03|||Mixed Model repeated Measures (MMRM)|Covariates: NT-proBNP-by-visit interaction and visit-by-treatment interaction. Unstructured covariance structure to model within-patient errors.|Adjusted geometric mean ratio \[Empagliflozin/Placebo\] of relative change to baseline.|The endpoint 'relative change from baseline in NT-proBNP at Week 12' (after log-transformation) was evaluated using an MMRM analysis over time with baseline log-transformed NT-proBNP-by-visit interaction and visit-by-treatment interaction as covariates.Unstructured covariance structure was used to model within-patient errors.||1.03|0.81|0.1410
73803349|NCT04548193|147156217|SUPERIORITY||Mean Difference (Final Values)|6.14||||0.28|TWO_SIDED|95.0|-5.72|17.99|||Wilcoxon (Mann-Whitney)|||||17.99|-5.72|0.28
73803350|NCT04548193|147156218|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.0054|TWO_SIDED|95.0|0.06|1.38|||Wilcoxon (Mann-Whitney)|||||1.38|0.06|.0054
73803351|NCT04548193|147156220|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.0098|TWO_SIDED|95.0|0.24|1.65|||Wilcoxon (Mann-Whitney)|||||1.65|0.24|.0098
73895358|NCT03615040|147324156|SUPERIORITY||Mean Difference (Net)|-3.3||||0.039|TWO_SIDED|95.0|-6.4|-0.2|||Mixed Models Analysis|||Calculated using mixed effect linear model with dependent variable of the outcome at baseline and follow-up time points (Week 4, 12, 24, 36, 48); explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score; an interaction term between treatment and visit as fixed effects; and patient identification as a random effect.||-0.2|-6.4|0.039
73895359|NCT03615040|147324157|SUPERIORITY||Mean Difference (Net)|0.53||||0.469|TWO_SIDED|95.0|-0.91|2.0|||Mixed Models Analysis|||Calculated using mixed effect linear model with dependent variable of the outcome at baseline and follow-up time points (Week 4, 12, 24, 36, 48); explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score; an interaction term between treatment and visit as fixed effects; and patient identification as a random effect.||2.00|-0.91|0.469
73895360|NCT03615040|147324158|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 4||||0.90
73895361|NCT03615040|147324158|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 12||||0.95
73895362|NCT03615040|147324158|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 24||||0.78
73895363|NCT03615040|147324158|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 36||||0.88
73895364|NCT03615040|147324158|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 48||||0.78
73895365|NCT03615040|147324159|SUPERIORITY||Mean Difference (Net)|-9.4||||0.236|TWO_SIDED|95.0|-24.9|6.2||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS total||6.2|-24.9|0.236
73895366|NCT03615040|147324159|SUPERIORITY||Mean Difference (Net)|-4.9||||0.083|TWO_SIDED|95.0|-10.6|0.7||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Dyspnoea||0.7|-10.6|0.083
73803352|NCT00630825|147156221|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803353|NCT00630825|147156221|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803354|NCT00630825|147156221|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73895367|NCT03615040|147324159|SUPERIORITY||Mean Difference (Net)|-2.1||||0.546|TWO_SIDED|95.0|-8.9|4.7||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Cough||4.7|-8.9|0.546
73895368|NCT03615040|147324159|SUPERIORITY||Mean Difference (Net)|-1.9||||0.527|TWO_SIDED|95.0|-7.8|4.0||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Sputum production||4.0|-7.8|0.527
73895369|NCT03615040|147324160|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 12||||0.84
73895370|NCT03615040|147324160|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 24||||0.52
73895371|NCT03615040|147324160|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 36||||0.82
73895372|NCT03615040|147324160|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 48||||0.95
73895373|NCT03615040|147324161|SUPERIORITY||Mean Difference (Final Values)|9.06||||0.069|TWO_SIDED|95.0|-0.83|18.97|||ANCOVA|||Pre BD FEV1/FVC ratio: Analysis of covariance (ANCOVA) adjusting for the baseline value||18.97|-0.83|0.069
73895374|NCT03615040|147324162|SUPERIORITY||Mean Difference (Net)|0.04||||0.094|TWO_SIDED|95.0|-0.01|0.09|||Mixed Models Analysis|||mixed effect linear model with explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score and patient identification as a random effect to account for repeated measures over time was fitted for each outcome. Adjusted mean difference between treatment arms with 95% confidence interval and p-value were reported. In the modified ITT population.||0.09|-0.01|0.094
73803355|NCT00630825|147156222|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803356|NCT00630825|147156222|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803357|NCT00630825|147156222|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803358|NCT00630825|147156223|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803359|NCT00630825|147156223|SUPERIORITY_OR_OTHER|||||||0.047||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.047
73803360|NCT00630825|147156223|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.025
73895375|NCT03615040|147324163|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.905|TWO_SIDED|95.0|-0.46|0.52||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Total Lung Capacity||0.52|-0.46|0.905
73895376|NCT03615040|147324163|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.775|TWO_SIDED|95.0|-0.62|0.47||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Residual Volume||0.47|-0.62|0.775
73895377|NCT03615040|147324164|SUPERIORITY||Geometric mean ratio|1.01||||0.736|TWO_SIDED|95.0|0.95|1.07||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||White blood cell count||1.07|0.95|0.736
73895378|NCT03615040|147324164|SUPERIORITY||Geometric mean ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.51|0.69||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||Eosinophil Count||0.69|0.51|<0.001
73895379|NCT03615040|147324164|SUPERIORITY||Geometric mean ratio|1.02||||0.678|TWO_SIDED|95.0|0.93|1.13||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||Neutrophil Count||1.13|0.93|0.678
73895380|NCT03615040|147324165|SUPERIORITY||Geometric mean ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.19|0.33||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects.|Mixed Models Analysis|||Eosinophil count||0.33|0.19|<0.001
73895381|NCT03615040|147324181|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.362|TWO_SIDED|95.0|-0.14|0.35|||ANCOVA|||Pre BD FVC (litres): Analysis of covariance (ANCOVA) adjusting for the baseline value||0.35|-0.14|0.362
73895382|NCT03615040|147324181|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.713|TWO_SIDED|95.0|-0.61|0.44|||ANCOVA|||Pre BD FVC (litre):Analysis of covariance (ANCOVA) adjusting for the baseline value||0.44|-0.61|0.713
73895383|NCT03615040|147324182|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.711|TWO_SIDED|95.0|-8.63|12.2|||ANCOVA|||Pre FEV1 predicted: Analysis of covariance (ANCOVA) adjusting for the baseline value||12.20|-8.63|0.711
73895384|NCT03615040|147324182|SUPERIORITY||Mean Difference (Final Values)|-10.4||||0.214|TWO_SIDED|95.0|-27.9|7.1|||ANCOVA|||Pre BD FVC predicted (%): Analysis of covariance (ANCOVA) adjusting for the baseline value||7.1|-27.9|0.214
73803361|NCT00630825|147156224|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73895385|NCT03615040|147324183|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.201|TWO_SIDED|95.0|-7.53|1.65||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Residual Volume/Total Lung Capacity ratio.||1.65|-7.53|0.201
73895386|NCT03615040|147324184|SUPERIORITY||Geometric mean ratio|0.75||||0.114|TWO_SIDED|95.0|0.52|1.07||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects|Mixed Models Analysis|||Macrophage count||1.07|0.52|0.114
73895387|NCT03615040|147324185|SUPERIORITY||Geometric mean ratio|0.79||||0.215|TWO_SIDED|95.0|0.54|1.15||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects.|Mixed Models Analysis|||Epithelium count||1.15|0.54|0.215
73895388|NCT01776307|147324186|OTHER|Descriptive analysis for investigational arms; no comparator analysis|||||||||||||||||The exact 95% confidence interval is based on the Clopper-Pearson method.|||
73803362|NCT00630825|147156224|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73895389|NCT01776307|147324187|OTHER|Estimates provided for investigational arms; no comparator analysis|||||||||||||||||Estimated from Kaplan Meier Curve|||
73895390|NCT01776307|147324188|OTHER|Estimates provided for investigational arms; no comparator analysis|||||||||||||||||Estimated from Kaplan Meier Curve|||
73895391|NCT04074161|147324208|SUPERIORITY|Responses were analysed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.|Treatment difference|-9.38|||<|0.0001|TWO_SIDED|95.0|-11.97|-6.8|||ANCOVA|||||-6.80|-11.97|<0.0001
73895392|NCT03890666|147324292|OTHER||Odds Ratio (OR)|1.33||||||||||||||The statistical model is a logistic regression model with treatment group as a fixed factor, pooled study sites as a random factor, and baseline ACT score as a covariate.||||
73895393|NCT03232333|147324313|SUPERIORITY||||||=|0.71|||||||t-test, 1 sided|||||||=0.71
73895394|NCT03232333|147324314|SUPERIORITY||||||=|0.63|||||||t-test, 1 sided|||||||=0.63
73895395|NCT03232333|147324315|SUPERIORITY||||||=|0.01|||||||t-test, 1 sided|||||||=.01
73803363|NCT00630825|147156224|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803364|NCT00630825|147156224|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803365|NCT00630825|147156224|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803366|NCT00630825|147156224|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803367|NCT00630825|147156224|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803368|NCT00630825|147156224|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803369|NCT00630825|147156224|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803370|NCT00630825|147156225|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803371|NCT00630825|147156225|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803372|NCT00630825|147156225|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.004
73803373|NCT00630825|147156225|SUPERIORITY_OR_OTHER|||||||0.904||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.904
73803374|NCT00630825|147156225|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANCOVA|Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.||||||0.138
73803375|NCT00630825|147156225|SUPERIORITY_OR_OTHER|||||||0.729||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.729
73803376|NCT00630825|147156227|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803377|NCT00630825|147156227|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803378|NCT00630825|147156227|SUPERIORITY_OR_OTHER|||||||0.113||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.113
73803379|NCT00630825|147156227|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803380|NCT00630825|147156227|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803381|NCT00630825|147156227|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803382|NCT00630825|147156227|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
73803383|NCT00630825|147156227|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.004
73803384|NCT00630825|147156227|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.001
73803385|NCT00630825|147156228|SUPERIORITY_OR_OTHER|||||||0.009||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.009
73803386|NCT00630825|147156228|SUPERIORITY_OR_OTHER|||||||0.028||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.028
73803387|NCT00630825|147156228|SUPERIORITY_OR_OTHER|||||||0.047||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.047
73803388|NCT02275819|147156237|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||.14
73803389|NCT02275819|147156238|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||||||.22
73803390|NCT02275819|147156239|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
73803391|NCT02275819|147156240|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||.08
73803392|NCT02275819|147156241|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
73803393|NCT01011816|147156250|SUPERIORITY_OR_OTHER|||||||0.52|||||||Fisher Exact|||Null: No differenc between the percent success of Saline and BIOSTAT BIOLOGX||||0.52
73803394|NCT02211209|147156253|SUPERIORITY||Least Squares Mean Difference|-94.1|||<|0.0001|TWO_SIDED|95.0|-121.7|-66.6|||ANCOVA|||||-66.6|-121.7|< 0.0001
73803395|NCT02211209|147156255|SUPERIORITY||Least Squares Mean Difference|-1804.0|STANDARD_ERROR_OF_MEAN|251.0|<|0.0001|TWO_SIDED|95.0|-2306.0|-1302.0|||ANCOVA|||||-1302|-2306|< 0.0001
73803396|NCT02211209|147156256|SUPERIORITY||Odds Ratio (OR)|186.16||||0.0001|TWO_SIDED|95.0|12.86||NA indicates that the upper limit of 95% CI was not estimable. The upper limit of the odds ratio estimate from the logistic regression model was \>999.999, and it was reported as NA per statistical reporting convention.||Regression, Logistic||||||12.86|0.0001
73803397|NCT02211209|147156257|SUPERIORITY||Odds Ratio (OR)|99.69|||<|0.0001|TWO_SIDED|95.0|15.75|631.06|||Regression, Logistic|||||631.06|15.75|<0.0001
73803398|NCT02211209|147156259|SUPERIORITY|||||||0.6131|||||||t-test, 2 sided|||||||0.6131
73803399|NCT02211209|147156260|SUPERIORITY||Least Squares Mean Difference|138.0||||0.1206|TWO_SIDED|95.0|-36.0|312.0|||ANCOVA|||||312|-36|0.1206
73803400|NCT02792062|147156263|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|113.06||||0.659|TWO_SIDED|90.0|70.37|181.67|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||181.67|70.37|0.659
73803401|NCT02792062|147156263|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|45.43||||0.012|TWO_SIDED|90.0|27.86|74.07|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||74.07|27.86|0.012
73803402|NCT02792062|147156264|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.28||||0.238|TWO_SIDED|90.0|66.09|107.47|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||107.47|66.09|0.238
73803403|NCT02792062|147156264|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|53.2|||<|0.001|TWO_SIDED|90.0|41.39|68.37|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||68.37|41.39|<0.001
73803404|NCT02792062|147156265|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.68||||0.256|TWO_SIDED|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||108.27|66.23|0.256
73803405|NCT02792062|147156265|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|52.56|||<|0.001|TWO_SIDED|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||67.74|40.78|<0.001
73803406|NCT02792062|147156266|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.68||||0.256|TWO_SIDED|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||108.27|66.23|0.256
73803407|NCT02792062|147156266|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|52.56|||<|0.001|TWO_SIDED|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||67.74|40.78|<0.001
73803408|NCT02220764|147156302|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||Null hypothesis: The chipping rates between tooth- and implant- supoorted FDPs are equally distributed.||||0.03
73803409|NCT03859427|147156336|NON_INFERIORITY|The non-inferiority margin was 0.87 for the estimated ORR risk ratio.|Risk Ratio (RR)|0.954||||0.0666|TWO_SIDED|95.0|0.882|1.032||P-value (2.5% significance level) of the non-inferiority test via the synthesis approach (FDA, 2016) for non-inferiority comparison of ORR between treatment arms.|Synthesis approach||Risk ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.032|0.882|0.0666
73803410|NCT03859427|147156338|OTHER||Odds Ratio (OR)|1.049|||||TWO_SIDED|95.0|0.653|1.683|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.683|0.653|
73895396|NCT03052426|147324316|SUPERIORITY|||||||0.9327||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.1394, DF 2 for aches||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for aches/pains at the three month time frame||||0.9327
73803411|NCT03859427|147156344|OTHER||Odds Ratio (OR)|1.235|||||TWO_SIDED|95.0|0.775|1.97|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.970|0.775|
73803412|NCT03859427|147156345|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.657|1.711|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.711|0.657|
73803413|NCT03859427|147156346|OTHER||Least Squares (LS) Mean Difference|2.53|||||TWO_SIDED|95.0|0.38|4.69|||||Analysis was based on repeated measures analysis of covariance (ANCOVA) model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.|||4.69|0.38|
73803414|NCT03859427|147156347|OTHER||LS Mean Difference|1.73|||||TWO_SIDED|95.0|-1.26|4.72|||||Analysis was based on ANCOVA model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.|||4.72|-1.26|
73803415|NCT03859427|147156348|OTHER||LS Mean difference|-0.26|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-2.54|2.03|||||Treatment difference at Cycle 5|||2.03|-2.54|
73803416|NCT03859427|147156348|OTHER||LS Mean difference|-0.48|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-3.24|2.28|||||Treatment difference at Cycle 12|||2.28|-3.24|
73803417|NCT03859427|147156348|OTHER||LS Mean difference|1.44|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|-1.69|4.58|||||Treatment difference at safety follow-up|||4.58|-1.69|
73803418|NCT03175536|147156371|SUPERIORITY||Mean Difference (Net)|3.4||||0.05|TWO_SIDED|95.0|-5.2|12.1|||GEE models|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||12.1|-5.2|0.05
73803419|NCT03175536|147156372|SUPERIORITY||Mean Difference (Net)|1.3||||0.05|TWO_SIDED|95.0|-4.4|7.0|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||7.0|-4.4|0.05
73803420|NCT03175536|147156373|SUPERIORITY||Mean Difference (Net)|6.0||||0.05|TWO_SIDED|95.0|0.7|11.3|||GEE model|Binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes.|||11.3|0.7|0.05
73895397|NCT03052426|147324316|SUPERIORITY|||||||0.7523||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.5693, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the three month time frame||||0.7523
73803421|NCT03175536|147156374|SUPERIORITY||Mean Difference (Net)|0.16||||0.05|TWO_SIDED|95.0|-0.74|1.06|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||1.06|-0.74|0.05
73803422|NCT03175536|147156375|SUPERIORITY||Median Difference (Net)|-34.0||||0.05|TWO_SIDED|95.0|-47.0|-21.0|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes.|||-21|-47|0.05
73803423|NCT01624740|147156397|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||ANOVA|Period effect p=0.11||||||0.74
73803424|NCT02999269|147156409|SUPERIORITY|||||||0.04||||||p-value for time by amplitude interaction|Regression, Linear|||For the primary outcomes (change in HDRS24), we performed a full longitudinal model with an unstructured repeated measures covariance matrix on subjects who completed the study in the assigned treatment arm. The dependent variable was HDRS at each visit and the independent variables included progress (time within the ECT series: pre-, mid-, and post-ECT), amplitude, age, sex, pulse width and the following interactions: progress/amplitude, progress/sex, and progress/pulse width.|Time-by-amplitude interaction (F4, 72 = 2.65, p = 0.04).|||0.04
73803425|NCT02999269|147156409|SUPERIORITY|||||||0.0001|||||||Regression, Linear|||||||0.0001
73803426|NCT02999269|147156410|SUPERIORITY|||||||0.37|||||||Regression, Linear|||||||0.37
73803427|NCT02999269|147156410|SUPERIORITY|||||||0.5||||||p-value is time-by-amplitude interaction|Regression, Linear|||||||0.50
73803428|NCT02999269|147156410|SUPERIORITY||||||<|0.01||||||Progress (F2,71 = 11.15, p \< 0.01)|Regression, Linear|||||||< 0.01
73803429|NCT01102257|147156418|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
73803430|NCT04003636|147156419|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0034|TWO_SIDED|95.0|0.72|0.95|||Regression, Cox|One-sided p-value based on log-rank test stratified by geographic region, disease status, site of origin with small strata collapsed|HR=Arm A/Arm B|||0.95|0.72|0.0034
73803431|NCT04003636|147156420|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0225|TWO_SIDED|95.0|0.75|1.0|||Regression, Cox|One-sided p-value based on log-rank test stratified by geographic region, disease status, site of origin with small strata collapsed|HR=Arm A/Arm B|||1.00|0.75|0.0225
73803432|NCT04003636|147156421|SUPERIORITY||Difference in Percentages|0.2||||0.4735|TWO_SIDED|95.0|-5.2|5.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0|Miettinen & Nurminen||Difference=Arm A minus Arm B|||5.6|-5.2|0.4735
73803433|NCT00162981|147156438|SUPERIORITY_OR_OTHER||||||<|0.0182||95.0|||||1-sided Wilcoxon signed rank test|1-sided Wilcoxon signed rank test was used to assess the difference from baseline.||||||<0.0182
73803434|NCT00162981|147156438|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||1-sided Wilcoxon signed rank test was used to assess the difference from baseline.|1-sided Wilcoxon signed rank test|||||||0.0001
73803435|NCT00162981|147156441|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 50%, one-tailed significance at 0.05 and a power of 80% to detect a reduction of at least 25% (baseline to final in a within-subjects design), then approximately 27 subjects would have been required in each treatment arm. Assuming a 10% drop-out rate, then approximately 30 subjects per treatment were to be enrolled in the study.|||||<|0.0001||95.0|||||1-sided Wilcoxon Rank-Sum Test|1-sided Wilcoxon Rank-Sum Test was used to compare the high dose group to the low dose group.||||||<0.0001
73803436|NCT00300235|147156443|SUPERIORITY_OR_OTHER||proportion of subjects|35.2||||||95.0|32.5|37.9||||||This was a survey designed to estimate prevalence, no formal comparisons between age or genotype groups were performed.||37.9|32.5|
73895398|NCT03052426|147324316|SUPERIORITY|||||||0.9196||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.1676, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the three month time frame.||||0.9196
73803437|NCT00375973|147156447|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Regression, Linear|||||||0.23
73803438|NCT00375973|147156448|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
73803439|NCT00375973|147156449|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Regression, Linear|||||||0.67
73803440|NCT00375973|147156450|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
73803441|NCT00375973|147156451|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Regression, Linear|||||||0.06
73803442|NCT00375973|147156452|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||||||0.02
73803443|NCT00375973|147156453|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Fisher Exact|||||||0.24
73803444|NCT03809663|147156464|SUPERIORITY||Odds Ratio (OR)|1.686||||0.56|TWO_SIDED|95.0|0.29|9.809||Nominal p-value|Regression, Logistic|||||9.809|0.290|0.56
73803445|NCT03809663|147156464|SUPERIORITY||Odds Ratio (OR)|1.011||||0.99|TWO_SIDED|95.0|0.135|7.551||Nominal p-value|Regression, Logistic|||||7.551|0.135|0.99
73803446|NCT03809663|147156464|SUPERIORITY||Odds Ratio (OR)|2.146||||0.38|TWO_SIDED|95.0|0.39|11.8||Nominal p-value|Regression, Logistic|||||11.800|0.390|0.38
73803447|NCT03809663|147156465|SUPERIORITY||Odds Ratio (OR)|0.982||||0.97|TWO_SIDED|95.0|0.344|2.803||Nominal p-value|Regression, Logistic|||||2.803|0.344|0.97
73803448|NCT03809663|147156465|SUPERIORITY||Odds Ratio (OR)|1.217||||0.7|TWO_SIDED|95.0|0.441|3.356||Nominal p-value|Regression, Logistic|||||3.356|0.441|0.70
73803449|NCT03809663|147156465|SUPERIORITY||Odds Ratio (OR)|0.73||||0.58|TWO_SIDED|95.0|0.243|2.197||Nominal p-value|Regression, Logistic|||||2.197|0.243|0.58
73803450|NCT03309943|147156473|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.019|||||||Mixed Models Analysis|Adjusted for FTCD. Carried out using SPSS Mixed Models with a repeated statement and compound symmetry covariance structure.||||||.019
73803451|NCT03309943|147156474|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.83|||||||Mixed Models Analysis|Adjusted for FTCD||||||.830
73803452|NCT03309943|147156475|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.006|||||||Mixed Models Analysis|||||||.006
73895399|NCT03052426|147324317|SUPERIORITY|||||||0.6316||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.9190, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSquare Analysis were completed||||0.6316
73895400|NCT03052426|147324317|SUPERIORITY|||||||0.2595||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 2.6983, DF||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the six month time frame.||||0.2595
73895401|NCT03052426|147324317|SUPERIORITY|||||||0.4495||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 1.5991, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the six month time frame||||0.4495
73895402|NCT03052426|147324318|SUPERIORITY||||||<|0.0001||||||Aches (F-test G-G Epsilon (1.26, 15.18) = 34.70, p \< 0.0001)|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.||||<0.0001
73895403|NCT03052426|147324318|SUPERIORITY||||||=|0.0006||||||Uncomfortable (F-test G-G Epsilon (1.43, 17.15) = 14.39, p = 0.0006), from time 1 to times 2 and 3|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.||||=0.0006
73895404|NCT03052426|147324318|SUPERIORITY||||||<|0.0001||||||Interference (F-test G-G Epsilon (1.55, 18.66) = 34.09, p \< 0.0001), from time 1 to times 2 and 3.|MANOVA|||We used repeated measures MANOVAs with pairwise comparisons to examine the decrease of the variables over time. Significant differences for within subjects by time were found||||<0.0001
73895405|NCT04145219|147324335|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.0001|TWO_SIDED|95.0|0.5|1.4||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average daily TCRS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.4|0.5|<0.0001
73895406|NCT04145219|147324336|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.0001|TWO_SIDED|95.0|0.2|0.6||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinitis DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.6|0.2|<0.0001
73895407|NCT04145219|147324337|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.0016|TWO_SIDED|95.0|0.2|0.8||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis|||The average rhinitis DMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.8|0.2|0.0016
73803453|NCT03309943|147156476|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.653|||||||Mixed Models Analysis|||||||.653
73895408|NCT04145219|147324338|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.0001|TWO_SIDED|95.0|0.6|1.7||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs.12 SQ-HDM|||1.7|0.6|<0.0001
73803454|NCT03309943|147156477|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.012|||||||Mixed Models Analysis|Adjusted for FTCD||||||.012
73803455|NCT03309943|147156478|SUPERIORITY|Mixed model analysis examining the effects of drug condition on PPI indexes while viewing proximal smoking cues (which drove activation effects).||||||0.013|||||||Mixed Models Analysis|||||||.013
73803456|NCT03309943|147156479|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.024|||||||Repeated Measures ANCOVA|Adjusted for FTCD.||||||.024
73803457|NCT03309943|147156480|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.086|||||||Repeated Measures ANCOVA|Adjusted for FTCD score||||||.086
73803458|NCT03309943|147156481|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.14|||||||Repeated Measures ANCOVA|Adjusted for FTCD score||||||.140
73803459|NCT03309943|147156482|SUPERIORITY|Standard ANCOVA analysis examining condition differences (adjusting for baseline craving and FTCD score).||||||0.556|||||||ANCOVA|Adjusted for baseline craving and FTCD score||||||.556
73803460|NCT03309943|147156483|SUPERIORITY|Standard ANCOVA analysis examining condition differences (adjusting for FTCD score).||||||0.463||||||Adjusted for FTCD score only.|ANCOVA|||||||.463
73803461|NCT00427648|147156514|SUPERIORITY|||||||0.588|||||||Kruskal-Wallis|||null hypothesis - no difference in average number of voids between the 2 groups, power calculation estimated 40 participants needed per arm to show a 2 void difference between lidocaine and saline placebo.||||0.588
73803462|NCT00427648|147156515|SUPERIORITY|||||||0.617|||||||Kruskal-Wallis|||||||0.617
73803463|NCT00427648|147156516|SUPERIORITY|||||||0.441|||||||Kruskal-Wallis|||||||0.441
73803464|NCT00427648|147156517|SUPERIORITY|||||||0.189|||||||Kruskal-Wallis|||||||0.189
73803465|NCT00427648|147156518|SUPERIORITY|||||||0.342|||||||Kruskal-Wallis|||||||0.342
73803466|NCT00427648|147156519|SUPERIORITY|||||||0.802|||||||Kruskal-Wallis|||||||0.802
73803467|NCT00427648|147156520|SUPERIORITY|||||||0.366|||||||Kruskal-Wallis|||||||0.366
73803468|NCT00386360|147156678|SUPERIORITY_OR_OTHER||LS Mean Difference|0.231||||0.7096|TWO_SIDED|95.0|-0.995|1.458|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.458|-0.995|0.7096
73803469|NCT00386360|147156679|SUPERIORITY_OR_OTHER||LS Mean Difference|0.543||||0.2973|TWO_SIDED|95.0|-0.485|1.571|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.571|-0.485|0.2973
73895409|NCT04145219|147324339|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.0001|TWO_SIDED|95.0|0.3|0.7|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.7|0.3|<0.0001
73895410|NCT04145219|147324340|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.0018|TWO_SIDED|95.0|0.2|1.0|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis DMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.0|0.2|0.0018
73803470|NCT00386360|147156680|SUPERIORITY_OR_OTHER||LS Mean Difference|0.485||||0.1275|TWO_SIDED|95.0|-0.141|1.11|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.110|-0.141|0.1275
73803471|NCT00386360|147156681|SUPERIORITY_OR_OTHER||LS Mean Difference|0.664||||0.336|TWO_SIDED|95.0|-0.697|2.025|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.025|-0.697|0.3360
73803472|NCT00386360|147156682|SUPERIORITY_OR_OTHER||LS Mean Difference|0.334||||0.4565|TWO_SIDED|95.0|-0.551|1.219|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.219|-0.551|0.4565
73803473|NCT00386360|147156683|SUPERIORITY_OR_OTHER||LS Mean Difference|0.611||||0.0614|TWO_SIDED|95.0|-0.03|1.252|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.252|-0.030|0.0614
73803474|NCT00386360|147156684|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.9212|TWO_SIDED|95.0|-1.258|1.138|||ANOVA|LS means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.138|-1.258|0.9212
73803475|NCT00386360|147156685|SUPERIORITY_OR_OTHER||LS Mean Difference|3.27|||<|0.0001|TWO_SIDED|95.0|2.231|4.31|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||4.310|2.231|<0.0001
73803476|NCT00386360|147156686|SUPERIORITY_OR_OTHER||LS Mean Difference|1.444|||<|0.0001|TWO_SIDED|95.0|0.748|2.14|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.140|0.748|<0.0001
73803477|NCT00386360|147156687|SUPERIORITY_OR_OTHER||LS Mean Difference|1.408||||0.0036|TWO_SIDED|95.0|0.469|2.348|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.348|0.469|0.0036
73803478|NCT00386360|147156688|SUPERIORITY_OR_OTHER||LS Mean Difference|1.458||||0.0087|TWO_SIDED|95.0|0.375|2.541|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.541|0.375|0.0087
73803479|NCT00386360|147156689|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.54||||0.0002|TWO_SIDED|95.0|-59.957|-19.123|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||-19.123|-59.957|0.0002
73803480|NCT00386360|147156690|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.269|||<|0.0001|TWO_SIDED|95.0|-51.3|-29.238|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||-29.238|-51.300|<0.0001
73803481|NCT00386360|147156691|SUPERIORITY_OR_OTHER||LS Mean Difference|0.092||||0.1385|TWO_SIDED|95.0|-0.03|0.213|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||0.213|-0.030|0.1385
73803482|NCT02230904|147156693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.115|STANDARD_DEVIATION|1.635|||TWO_SIDED|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.||||
73803483|NCT02230904|147156700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.442|STANDARD_DEVIATION|0.895|||TWO_SIDED|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.||||
73803484|NCT01511978|147156716|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73803485|NCT01511978|147156717|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
73803486|NCT01575834|147156730|SUPERIORITY||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.15|0.47||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.47|0.15|< 0.001
73803487|NCT01575834|147156731|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.39||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.39|0.15|< 0.001
73803488|NCT01575834|147156732|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.008|TWO_SIDED|95.0|0.46|0.89||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.89|0.46|0.008
73803489|NCT01575834|147156733|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.096|TWO_SIDED|95.0|0.53|1.05||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.05|0.53|0.096
73803490|NCT01575834|147156734|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.057|TWO_SIDED|95.0|0.57|0.97||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.97|0.57|0.057
73803491|NCT01575834|147156735|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.52|0.87||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.87|0.52|0.096
73803492|NCT01575834|147156736|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.44|1.02||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.02|0.44|0.096
73803493|NCT01575834|147156737|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.49|0.91||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab|||0.91|0.49|0.096
73803494|NCT01575834|147156738|SUPERIORITY||Odds Ratio (OR)|0.28||||0.096|TWO_SIDED|95.0|0.17|0.49||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.49|0.17|0.096
73803495|NCT01575834|147156739|SUPERIORITY||Odds Ratio (OR)|0.26||||0.096|TWO_SIDED|95.0|0.16|0.41||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test|Values \< 1 for odds ratio favor romosozumab.|||0.41|0.16|0.096
73803496|NCT01575834|147156740|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.18|TWO_SIDED|95.0|0.22|1.35||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.35|0.22|0.18
73803497|NCT01575834|147156741|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.12|TWO_SIDED|95.0|0.24|1.04||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.04|0.24|0.12
73803498|NCT01575834|147156742|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.012|TWO_SIDED|95.0|0.4|0.9|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.90|0.40|0.012
73895411|NCT04145219|147324341|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.2||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The overall PRQLQ score was analysed using a linear mixed effect (LME) model. The model includes the overall PRQLQ score as response variable, treatment and cohort as fixed factors, the baseline overall PRQLQ score as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.2|0.1|<0.0001
73803499|NCT01575834|147156743|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.002|TWO_SIDED|95.0|0.46|0.84|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.84|0.46|0.002
73803500|NCT01575834|147156744|SUPERIORITY||Odds Ratio (OR)|0.11||||0.011|TWO_SIDED|95.0|0.01|0.87|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.87|0.01|0.011
73803501|NCT01575834|147156745|SUPERIORITY||Odds Ratio (OR)|0.06|||<|0.001|TWO_SIDED|95.0|0.01|0.44|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.44|0.01|< 0.001
73803502|NCT01575834|147156746|SUPERIORITY||LS Mean Difference|12.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|12.4|12.9|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||12.9|12.4|< 0.001
73803503|NCT01575834|147156747|SUPERIORITY||LS Mean Difference|11.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|10.8|11.4|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||11.4|10.8|< 0.001
73895412|NCT04145219|147324342|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.0259|TWO_SIDED|95.0|0.0|0.2|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average asthma DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.2|0.0|0.0259
73803504|NCT01575834|147156748|SUPERIORITY||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|5.6|6.0|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||6.0|5.6|< 0.001
73803505|NCT01575834|147156749|SUPERIORITY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|5.1|5.5|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.5|5.1|< 0.001
73803506|NCT01575834|147156750|SUPERIORITY||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|4.9|5.4|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.4|4.9|< 0.001
73803507|NCT01575834|147156751|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|4.7|5.2|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.2|4.7|< 0.001
73803508|NCT02282813|147156766|SUPERIORITY_OR_OTHER|||||||0.1041|||||||Cochran-Mantel-Haenszel|||||||0.1041
73803509|NCT02282813|147156767|SUPERIORITY_OR_OTHER|||||||0.0503|||||||Cochran-Mantel-Haenszel|||||||.0503
73803510|NCT02282813|147156768|SUPERIORITY_OR_OTHER|||||||0.4817|||||||Cochran-Mantel-Haenszel|||||||0.4817
73803511|NCT02282813|147156769|SUPERIORITY_OR_OTHER|||||||0.8086|||||||Cochran-Mantel-Haenszel|||||||0.8086
73803512|NCT03858998|147156770|SUPERIORITY||Risk Difference (RD)|0.004||||0.91|TWO_SIDED|95.0|-0.06|0.07|||Chi-squared||Direction = Linkage minus SOC|||0.07|-0.06|0.91
73803513|NCT05000164|147156801|SUPERIORITY||Least-square Mean|-0.12|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.17|-0.07|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.0 logMAR for distance.|Distance (4m)||-0.07|-0.17|
73803514|NCT05000164|147156801|SUPERIORITY||Least-square Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|-0.06|0.04|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.17 logMAR for intermediate.|Intermediate (64cm)||0.04|-0.06|
73803515|NCT05000164|147156801|SUPERIORITY||Least-square Mean|0.09|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|0.04|0.15|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.17 logMAR for near.|Near (40cm)||0.15|0.04|
73803516|NCT06509438|147156820|OTHER|Compare 4 weeks after the last injection to baseline|Difference of medians|-0.45|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73803517|NCT06509438|147156820|OTHER|Compare 12 weeks after the last injection to baseline|Difference of medians|-0.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73803518|NCT03331796|147156824|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|3.1||0.63|TWO_SIDED|95.0|-4.8|7.9|||Regression, Linear|Adjusted for baseline||||7.9|-4.8|0.63
73803519|NCT03331796|147156824|SUPERIORITY||Mean Difference (Final Values)|6.9|STANDARD_ERROR_OF_MEAN|3.3||0.0476|TWO_SIDED|95.0|0.1|13.7|||Regression, Linear|||||13.7|0.1|0.0476
73803520|NCT03331796|147156825|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|4.1||0.45|TWO_SIDED|95.0|-11.4|5.2|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.2|-11.4|0.45
73803521|NCT03331796|147156825|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|4.4||0.21|TWO_SIDED|95.0|-3.3|14.8|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||14.8|-3.3|0.21
73803522|NCT03331796|147156826|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.38||0.29|TWO_SIDED|95.0|-0.36|1.19|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.19|-0.36|0.29
73803523|NCT03331796|147156826|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.4||0.51|TWO_SIDED|95.0|-0.55|1.08|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.08|-0.55|0.51
73803524|NCT03331796|147156827|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.33|TWO_SIDED|95.0|-1.0|3.0|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.0|-1.0|.33
73803525|NCT03331796|147156827|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.0||0.0038|TWO_SIDED|95.0|1.1|5.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.3|1.1|0.0038
73803526|NCT03331796|147156828|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.78||0.58|TWO_SIDED|95.0|-1.1|2.0|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.0|-1.1|0.58
73803527|NCT03331796|147156828|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.86||0.59|TWO_SIDED|95.0|-2.2|1.3|||Regression, Linear|Adjusted for baseline||||1.3|-2.2|0.59
73803528|NCT03331796|147156829|SUPERIORITY||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|5.2||0.3|TWO_SIDED|95.0|-5.2|16.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||16.1|-5.2|0.30
73803529|NCT03331796|147156829|SUPERIORITY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|4.9||0.34|TWO_SIDED|95.0|-14.9|5.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.3|-14.9|0.34
73803530|NCT03331796|147156830|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|10.6||0.996|TWO_SIDED|95.0|-22.0|22.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||22.1|-22.0|0.996
73803531|NCT03331796|147156830|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|10.8||0.87|TWO_SIDED|95.0|-20.6|24.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||24.3|-20.6|0.87
73803532|NCT03331796|147156831|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|1.06||0.97|TWO_SIDED|95.0|-2.14|2.22|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.22|-2.14|0.97
73803533|NCT03331796|147156831|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|1.11||0.91|TWO_SIDED|95.0|-2.15|2.41|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.41|-2.15|0.91
73803534|NCT03331796|147156832|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_DEVIATION|1.0||0.84|TWO_SIDED|95.0|-2.3|1.9|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.9|-2.3|0.84
73803535|NCT03331796|147156832|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|1.0||0.8|TWO_SIDED|95.0|-1.9|2.4|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.4|-1.9|0.80
73803536|NCT03331796|147156833|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|2.0||0.48|TWO_SIDED|95.0|-5.5|2.6|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.6|-5.5|0.48
73803537|NCT03331796|147156833|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|2.0||0.18|TWO_SIDED|95.0|-6.8|1.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.3|-6.8|0.18
73803538|NCT03331796|147156834|SUPERIORITY||Median Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.5||0.075|TWO_SIDED|95.0|-5.7|0.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.3|-5.7|0.075
73803539|NCT03331796|147156834|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.6||0.195|TWO_SIDED|95.0|-5.4|1.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.1|-5.4|0.195
73803540|NCT03331796|147156835|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.28|TWO_SIDED|95.0|-1.0|3.4|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.4|-1.0|0.28
73803541|NCT03331796|147156835|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.1||0.21|TWO_SIDED|95.0|-0.8|3.6|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.6|-0.8|0.21
73803542|NCT03331796|147156836|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.66|TWO_SIDED|95.0|-3.2|2.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.1|-3.2|0.66
73803543|NCT03331796|147156836|SUPERIORITY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.3||0.11|TWO_SIDED|95.0|-4.9|0.5|||Regression, Linear|||a priori threshold for statistical significance = .05||0.5|-4.9|0.11
73803544|NCT03331796|147156837|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.11||0.59|TWO_SIDED|95.0|-0.29|0.17|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.17|-0.29|0.59
73803545|NCT03331796|147156837|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.64|TWO_SIDED|95.0|-0.17|0.28|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.28|-0.17|0.64
73803546|NCT03331796|147156840|SUPERIORITY|||||||0.768||||||a priori threshold for statistical significance = .05|ANOVA|||||||0.768
73803547|NCT00720213|147156853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|STANDARD_DEVIATION|8.03||0.0054|TWO_SIDED|95.0|1.44|6.51|||Wilcoxon Signed Rank test|||Each participant was treated with the BiPAP autoSV2 (ASV2) and autoSV Advanced (ASV3) on two separate nights; therefore, the data were analyzed as paired samples. Depending on normality, each endpoint was analyzed with either a paired t-test or the nonparametric Wilcoxon Signed Ranks test. All comparisons were 2-sided conducted at a 5% level of significance.||6.51|1.44|0.0054
73803548|NCT01420068|147156884|SUPERIORITY||Mean Difference (Net)|0.31||||0.84|TWO_SIDED|95.0|-2.74|3.37||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline weight as covariates.||||3.37|-2.74|0.840
73803549|NCT01420068|147156885|SUPERIORITY||Mean Difference (Net)|0.69||||0.303|TWO_SIDED|95.0|-0.63|2.02||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline height as covariates.||||2.02|-0.63|0.303
73803550|NCT01420068|147156886|SUPERIORITY||Mean Difference (Net)|0.03||||0.957|TWO_SIDED|95.0|-1.06|1.12||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline BMI as covariates.||||1.12|-1.06|0.957
73803551|NCT01420068|147156888|SUPERIORITY||Mean Difference (Net)|0.02||||0.992|TWO_SIDED|95.0|-3.29|3.33||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||3.33|-3.29|0.992
73803552|NCT01420068|147156888|SUPERIORITY||Mean Difference (Net)|-3.06||||0.215|TWO_SIDED|95.0|-8.22|2.1||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||2.10|-8.22|0.215
73803553|NCT01420068|147156889|SUPERIORITY||Mean Difference (Net)|0.62||||0.403|TWO_SIDED|95.0|-0.85|2.09||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||2.09|-0.85|0.403
73803554|NCT01420068|147156889|SUPERIORITY||Mean Difference (Net)|0.92||||0.67|TWO_SIDED|95.0|-3.74|5.57||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||5.57|-3.74|0.670
73803555|NCT01420068|147156890|SUPERIORITY||Mean Difference (Net)|-0.11||||0.86|TWO_SIDED|95.0|-1.29|1.08||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||1.08|-1.29|0.860
73803556|NCT01420068|147156890|SUPERIORITY||Mean Difference (Net)|-1.17||||0.32|TWO_SIDED|95.0|-3.66|1.32||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||1.32|-3.66|0.320
73803557|NCT02554682|147156892|SUPERIORITY|||||||0.906|||||||Generalized Linear Model|||||||.906
73803558|NCT02554682|147156892|SUPERIORITY|||||||0.796|||||||Generalized Linear Model|||||||.796
73803559|NCT02554682|147156892|SUPERIORITY|||||||0.886|||||||Generalized Linear Model|||||||.886
73803560|NCT02554682|147156892|OTHER|||||||0.082|||||||Generalized Linear Model|||||||.082
73803561|NCT02554682|147156893|SUPERIORITY|||||||0.677|||||||Generalized Linear Model|||||||0.677
73803562|NCT02554682|147156893|SUPERIORITY|||||||0.02|||||||Generalized Linear Model|||||||0.020
73803563|NCT02554682|147156893|SUPERIORITY|||||||0.952|||||||Generalized Linear Model|||||||.952
73803564|NCT02554682|147156893|SUPERIORITY|||||||0.21|||||||Generalized Linear Model|||||||0.210
73803565|NCT02554682|147156894|SUPERIORITY|||||||0.505|||||||Generalized Linear Model|||||||0.505
73803566|NCT02554682|147156894|SUPERIORITY|||||||0.176|||||||Generalized Linear Model|||||||.176
73803567|NCT02554682|147156894|SUPERIORITY|||||||0.134|||||||Generalized Linear Model|||||||0.134
73803568|NCT02554682|147156894|SUPERIORITY|||||||0.029|||||||Generalized Linear Model|||||||0.029
73803569|NCT02554682|147156895|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||||||.037
73803570|NCT02554682|147156896|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
73803571|NCT02554682|147156897|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
73803572|NCT02554682|147156898|SUPERIORITY|||||||0.571|||||||t-test, 2 sided|||||||.571
73803573|NCT02554682|147156899|SUPERIORITY|||||||0.394|||||||t-test, 2 sided|||||||.394
73803574|NCT02554682|147156900|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||.008
73803575|NCT02554682|147156901|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
73803576|NCT02554682|147156902|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
73803577|NCT02554682|147156903|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||.159
73803578|NCT02554682|147156904|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||||||.112
73803579|NCT02554682|147156905|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||||||.165
73803580|NCT02554682|147156906|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
73803581|NCT00758290|147156907|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
73803582|NCT00884117|147156918|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<0.0001
73803583|NCT00884117|147156918|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Pairwise Wilcoxon|||||||<0.01
73803584|NCT00884117|147156918|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Pairwise Wilcoxon|||||||<0.01
73803585|NCT00884117|147156919|SUPERIORITY_OR_OTHER|||||||0.015|||||||Kruskal-Wallis|||||||0.015
73803586|NCT00884117|147156919|SUPERIORITY_OR_OTHER|||||||0.009|||||||Pairwise Wilcoxon|||||||0.009
73803587|NCT00884117|147156919|SUPERIORITY_OR_OTHER|||||||0.03|||||||Pairwise Wilcoxon|||||||0.03
73803588|NCT00884117|147156920|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Kruskal-Wallis|||||||0.0005
73803589|NCT00884117|147156920|SUPERIORITY_OR_OTHER|||||||0.008|||||||Pairwise Wilcoxon|||||||0.008
73803590|NCT00884117|147156920|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Pairwise Wilcoxon|||||||<0.0001
73803591|NCT00884117|147156921|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Kruskal-Wallis|||||||0.0002
73803592|NCT00884117|147156921|SUPERIORITY_OR_OTHER|||||||0.008|||||||Pairwise Wilcoxon|||||||0.008
73803593|NCT00884117|147156921|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Pairwise Wilcoxon|||||||<0.0001
73803594|NCT00884117|147156924|SUPERIORITY_OR_OTHER|||||||0.4464|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||0.4464
73803595|NCT00884117|147156925|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||<0.0001
73803596|NCT00884117|147156926|SUPERIORITY_OR_OTHER|||||||0.2499|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||0.2499
73803597|NCT04830969|147156935|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.16
73803598|NCT04830969|147156936|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.08
73803599|NCT04830969|147156937|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.14
73803600|NCT04830969|147156937|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.8
73803601|NCT04830969|147156938|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||<0.01
73803602|NCT04830969|147156938|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.09
73803603|NCT04830969|147156939|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||< 0.01
73803604|NCT04830969|147156939|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.03
73803605|NCT04830969|147156940|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||< 0.01
73803606|NCT04830969|147156940|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.09
73803607|NCT04830969|147156941|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Baseline to 3 months||||0.01
73803608|NCT04830969|147156941|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.86
73803609|NCT04830969|147156941|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||Baseline to 6 months||||0.047
73803610|NCT04830969|147156941|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.75
73803611|NCT04830969|147156942|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Baseline to 3 months||||0.44
73803612|NCT04830969|147156942|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.22
73803613|NCT04830969|147156942|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Baseline to 6 months||||0.29
73803614|NCT04830969|147156942|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.15
73803615|NCT04830969|147156943|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Baseline to 3 months||||<0.01
73803616|NCT04830969|147156943|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.31
73803617|NCT04830969|147156943|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline to 6 months||||0.08
73803618|NCT04830969|147156943|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.54
73803619|NCT04830969|147156944|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Baseline to 3 months||||0.01
73803620|NCT04830969|147156944|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.04
73803621|NCT04830969|147156944|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Baseline to 6 months||||0.03
73803622|NCT04830969|147156944|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.38
73803623|NCT04830969|147156945|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline to 3 months||||0.02
73803624|NCT04830969|147156945|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.18
73803625|NCT04830969|147156945|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline to 6 months||||0.08
73803626|NCT04830969|147156945|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.41
73803627|NCT04830969|147156946|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.27
73803628|NCT04830969|147156947|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.54
73803629|NCT04830969|147156948|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.12
73803630|NCT04830969|147156949|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
73803631|NCT04830969|147156949|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.07
73803632|NCT04830969|147156950|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
73803633|NCT04830969|147156950|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.64
73803634|NCT04830969|147156951|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
73803635|NCT04830969|147156951|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.11
73803636|NCT04830969|147156952|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||at baseline||||0.7
73803637|NCT04830969|147156952|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||6 months||||0.29
73803638|NCT04830969|147156953|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
73803639|NCT01153815|147156970|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Exact Smirnov test|||||||<0.001
73803640|NCT01786993|147156979|SUPERIORITY_OR_OTHER||Event-Free Probability|0.932|||||TWO_SIDED|95.0|0.904|0.951||||||"The hypothesis is formally expressed as:~H0: Freedom from system-related complications through 9 months ≤ 75% Ha: Freedom from system-related complications through 9 months \> 75%"||0.951|0.904|
73803641|NCT01786993|147156980|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a binomial distribution with a 44% probability for non-responders between 3 months and 9 months in both study arms, the sample size required for 85% power to reject the null hypothesis at the 5% significance level is 394. To adjust for a potential net crossover of 15% and an overall attrition rate of 20%, the total number of patients required to be enrolled in this study is 506.|Difference of proportions|-0.049||||0.0131|ONE_SIDED|97.5|-0.138||||normal approximation for binomial dist|||"H0: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) ≤ -0.15~Ha: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) \> -0.15~The null hypothesis will be rejected at the 2.5% significance level if the lower one-sided 97.5% confidence bound for the difference in the proportions is above -0.15."|||-0.138|0.0131
73803642|NCT01890122|147156981|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-0.7|-0.278||An analysis of covariance (ANCOVA) model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA|||||-0.278|-0.700|< 0.0001
73803643|NCT01890122|147156981|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.108|<|0.0001|TWO_SIDED|95.0|-0.889|-0.467||An ANCOVA model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA|||||-0.467|-0.889|< 0.0001
73803644|NCT02505217|147157004|SUPERIORITY|||||||0.007|||||||Regression, Cox|||||||0.007
73803645|NCT00953654|147157015|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|The degrees of freedom were adjusted when the sphericity assumption was violated based on Mauchly's test.||Effects of RET and AET were compared to WL using a 3 condition by 3 time ANCOVA. An a priori statistical power analysis showed that a sample of 30 patients would provide a statistical power of .80 to detect a condition-by-time interaction for PSWQ scores assuming a two-tailed alpha value of 0.05, a correlation across repeated measures of 0.75 and a desire to detect a standardized effect size of 0.65.||||<0.05
73803646|NCT02712554|147157032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73803647|NCT02712554|147157032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73803648|NCT02712554|147157032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2344|||||||ANOVA|||||||0.2344
73803649|NCT02712554|147157032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4737|||||||ANOVA|||||||0.4737
73803650|NCT02712554|147157032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73803651|NCT02712554|147157032|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73803652|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
73803653|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
73803654|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1267|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1267
73803655|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1767|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1767
73803656|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
73803657|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
73803658|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0119|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0119
73803659|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||0.0025
73803660|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1679
73803661|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0318|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0318
73803662|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||0.0002
73803663|NCT02712554|147157036|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<.0001
73803664|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
73803665|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
73803666|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0858|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0858
73803667|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2877|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.2877
73803668|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
73803669|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
73803670|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0009
73803671|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||0.0001
73803672|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1130
73803673|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0575|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0575
73803674|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||<.0001
73803675|NCT02712554|147157037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo||||<.0001
73803676|NCT02712554|147157038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
73803677|NCT02712554|147157038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
73803678|NCT02712554|147157038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4025|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.4025
73803679|NCT02712554|147157038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3184|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.3184
73803680|NCT02712554|147157038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
73803681|NCT02712554|147157038|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
73803682|NCT02712554|147157039|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<.0001
73803683|NCT02712554|147157039|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<.0001
73803684|NCT02712554|147157039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2628|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2628
73803685|NCT02712554|147157039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2262|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.2262
73803686|NCT02712554|147157039|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<.0001
73803687|NCT02712554|147157039|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<.0001
73803688|NCT02712554|147157040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
73803689|NCT02712554|147157040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
73803690|NCT02712554|147157040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1839|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1839
73803691|NCT02712554|147157040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1751|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1751
73803692|NCT02712554|147157040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
73803693|NCT02712554|147157040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
73803694|NCT02712554|147157041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<.0001
73803695|NCT02712554|147157041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<.0001
73803696|NCT02712554|147157041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4013|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.4013
73803697|NCT02712554|147157041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0736|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0736
73803698|NCT02712554|147157041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<.0001
73803699|NCT02712554|147157041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<.0001
73803700|NCT02712554|147157042|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<0.001
73803701|NCT02712554|147157042|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<0.001
73803702|NCT02712554|147157042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2223|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2223
73803703|NCT02712554|147157042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1638|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1638
73803704|NCT02712554|147157042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||0.0041
73803705|NCT02712554|147157042|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<0.001
73803706|NCT02712554|147157043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||0.0001
73803707|NCT02712554|147157043|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
73803708|NCT02712554|147157043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2706|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2706
73803709|NCT02712554|147157043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5507|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.5507
73803710|NCT02712554|147157043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||0.0047
73803711|NCT02712554|147157043|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
73803712|NCT02712554|147157044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0001
73803713|NCT02712554|147157044|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||<0.0001
73803714|NCT02712554|147157044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0014
73803715|NCT02712554|147157044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0080
73803716|NCT02712554|147157044|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||<0.0001
73803717|NCT02712554|147157044|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo||||<0.0001
73803718|NCT02712554|147157045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||0.0024
73803719|NCT02712554|147157045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||0.0012
73803720|NCT02712554|147157045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0037
73803721|NCT02712554|147157045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0011
73803722|NCT02712554|147157045|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
73803723|NCT02712554|147157045|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
73803724|NCT02712554|147157046|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<0.0001
73803725|NCT02712554|147157046|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<0.0001
73803726|NCT02712554|147157046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0630
73803727|NCT02712554|147157046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4436|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.4436
73803728|NCT02712554|147157046|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<0.0001
73803729|NCT02712554|147157046|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<0.0001
73803730|NCT02712554|147157047|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<0.0001
73803731|NCT02712554|147157047|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
73803732|NCT02712554|147157047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2335|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2335
73803733|NCT02712554|147157047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1808
73803734|NCT02712554|147157047|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
73803735|NCT02712554|147157047|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
73803736|NCT02712554|147157050|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment C (low-dose M366) - Placebo||||<0.0001
73803737|NCT02712554|147157050|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Treatment D: M366 37.5 mg/1625 mg, Treatment E: Placebo||||<0.0001
73803738|NCT02712554|147157050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1268|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1268
73803739|NCT02712554|147157050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0014
73803740|NCT02712554|147157050|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Placebo||||<0.0001
73803741|NCT02712554|147157050|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Placebo||||<0.0001
73803742|NCT02712554|147157051|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<0.0001
73803743|NCT02712554|147157051|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
73803744|NCT02712554|147157051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0120
73803745|NCT02712554|147157051|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||<0.0001
73803746|NCT02712554|147157051|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
73803747|NCT02712554|147157051|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
73803748|NCT03055338|147157089|SUPERIORITY||Difference in LSM|2.6||||0.44|TWO_SIDED|95.0|-4.0|9.2|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Risperidone|||9.2|-4.0|0.440
73803749|NCT03055338|147157089|SUPERIORITY||Difference in LSM|-4.7||||0.074|TWO_SIDED|95.0|-9.8|0.5|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Placebo|||0.5|-9.8|0.074
73803750|NCT03055338|147157089|SUPERIORITY||Difference in LSM|-7.3||||0.033|TWO_SIDED|95.0|-14.0|-0.6|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = Risperidone - Placebo|||-0.6|-14.0|0.033
73803751|NCT03055338|147157090|OTHER||Difference in % versus Placebo|17.2|||||TWO_SIDED|95.0|3.0|30.8|||||Difference in % = MK-8918 - Placebo||Based on Miettinen \& Nurminen method.|30.8|3.0|
73803752|NCT03055338|147157091|OTHER||Difference in % versus Placebo|-1.2|||||TWO_SIDED|95.0|-9.6|7.0|||||Difference in % = MK-8918 - Placebo||Based on Miettinen \& Nurminen method.|7.0|-9.6|
73803753|NCT03055338|147157092|OTHER||Difference in LSM|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Difference in LSM = MK-8189 - Risperidone|||0.6|-0.2|
73803754|NCT03055338|147157092|OTHER||Difference in LSM|-0.2|||||TWO_SIDED|95.0|-0.5|0.2|||||Difference in LSM = MK-8189 - Placebo|||0.2|-0.5|
73803755|NCT03055338|147157092|OTHER||Difference in LSM|-0.4|||||TWO_SIDED|95.0|-0.8|0.1|||||Difference in LSM = Risperidone - Placebo|||0.1|-0.8|
73803756|NCT00457002|147157110|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.4364|TWO_SIDED|95.0|0.62|1.23|||Mantel Haenszel|||To conclude superiority of apixaban versus enoxaparin on the primary efficacy endpoint, the upper bound of the two-sided 95.004% confidence interval (CI) for the relative risk (pa/ pe) must be less than 1.||1.23|0.62|0.4364
73803757|NCT00457002|147157110|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.39|||||TWO_SIDED|95.0|-1.37|0.59||||||||0.59|-1.37|
73803758|NCT00457002|147157111|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.69|1.63||||||Formal testing of noninferiority for the key secondary efficacy endpoint was not performed since the superiority of the primary efficacy endpoint was not demonstrated.||1.63|0.69|
73803759|NCT00457002|147157111|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.61|0.81||||||||0.81|-0.61|
73803760|NCT00457002|147157112|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.7|1.71||||||||1.71|0.70|
73803761|NCT00457002|147157112|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.14|||||TWO_SIDED|95.0|-0.57|0.85||||||||0.85|-0.57|
73803762|NCT00457002|147157113|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.78|1.2||||||||1.20|0.78|
73803763|NCT00457002|147157113|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-1.65|1.17||||||||1.17|-1.65|
73803764|NCT00457002|147157114|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.79|1.22||||||||1.22|0.79|
73803765|NCT00457002|147157114|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.12|||||TWO_SIDED|95.0|-1.52|1.29||||||||1.29|-1.52|
73803766|NCT00457002|147157115|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.29||||||||1.29|0.65|
73803767|NCT00457002|147157115|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.26|||||TWO_SIDED|95.0|-1.23|0.71||||||||0.71|-1.23|
73803768|NCT00457002|147157116|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.11|4.05||||||||4.05|0.11|
73803769|NCT00457002|147157116|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.16|0.1||||||||0.10|-0.16|
73803770|NCT00457002|147157117|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.68|1.16||||||||1.16|0.68|
73803771|NCT00457002|147157117|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-1.25|0.48||||||||0.48|-1.25|
73803772|NCT00457002|147157118|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.26|0.96||||||||0.96|0.26|
73803773|NCT00457002|147157118|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-0.78|-0.03||||||||-0.03|-0.78|
73803774|NCT00457002|147157119|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.84|1.28||||||||1.28|0.84|
73803775|NCT00457002|147157119|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-1.18|1.73||||||||1.73|-1.18|
73803776|NCT00457002|147157120|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.32|2.43||||||||2.43|0.32|
73803777|NCT00457002|147157120|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.26|0.2||||||||0.20|-0.26|
73803778|NCT00457002|147157121|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.32|2.43||||||||2.43|0.32|
73803779|NCT00457002|147157121|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.26|0.2||||||||0.20|-0.26|
73803780|NCT00457002|147157122|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31|||||TWO_SIDED|95.0|0.11|0.83||||||||0.83|0.11|
73803781|NCT00457002|147157122|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.34|||||TWO_SIDED|95.0|-0.62|-0.07||||||||-0.07|-0.62|
73803782|NCT00457002|147157123|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.65|1.37||||||||1.37|0.65|
73803783|NCT00457002|147157123|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-1.04|0.76||||||||0.76|-1.04|
73803784|NCT00457002|147157124|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.29|-0.02||||||Note: Relative risk was not estimable (0.0); only risk difference could be estimated.||-0.02|-0.29|
73803785|NCT00457002|147157125|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||||TWO_SIDED|95.0|0.14|1.16||||||||1.16|0.14|
73803786|NCT00457002|147157125|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.22|||||TWO_SIDED|95.0|-0.47|0.03||||||||0.03|-0.47|
73803787|NCT00457002|147157126|SUPERIORITY_OR_OTHER||Adjusted Difference of event rates|0.29||||0.0437|TWO_SIDED|95.0|0.01|0.57||The Mantel-Haenszel test stratified by the stratification factors will be used at the one-sided alpha=0.025 level.|Mantel Haenszel|||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||0.57|0.01|0.0437
73803788|NCT00457002|147157127|SUPERIORITY_OR_OTHER||Adjusted Difference of event rates|0.36|||||TWO_SIDED|95.0|-0.33|1.06||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||1.06|-0.33|
73803789|NCT00457002|147157128|SUPERIORITY_OR_OTHER||Adjustted difference of event rates|0.59|||||TWO_SIDED|95.0|-16.0|1.33||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||1.33|-016|
73803790|NCT00457002|147157129|SUPERIORITY_OR_OTHER||Adjusted Difference of Event Rates|0.87|||||TWO_SIDED|95.0|-0.4|2.14||||||||2.14|-0.40|
73803791|NCT00457002|147157130|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.74|1.61||||||||1.61|0.74|
73803792|NCT00457002|147157130|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-0.66|1.07||||||||1.07|-0.66|
73803793|NCT00457002|147157139|SUPERIORITY_OR_OTHER||Adjusted Event rate difference|0.0|||||TWO_SIDED|95.0|-0.3|0.29|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference in event rates in MI or stroke.||0.29|-0.30|
73803794|NCT00457002|147157139|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|0.09|||||TWO_SIDED|95.0|-0.11|0.3|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates for myocardial infarction.||0.30|-0.11|
73803795|NCT00457002|147157139|SUPERIORITY_OR_OTHER||Adjusted difference in event rates|-0.1|||||TWO_SIDED|95.0|-0.32|0.12||||||Adjusted difference in event rates for stroke.||0.12|-0.32|
73803796|NCT00457002|147157139|SUPERIORITY_OR_OTHER||Adjusted difference in event rates|0.09|||||TWO_SIDED|95.0|-0.09|0.28|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates in thrombocytopenia.||0.28|-0.09|
73803797|NCT04506463|147157167|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.850
73803798|NCT04506463|147157167|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||||||0.085
73803799|NCT04506463|147157167|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.850
73803800|NCT04506463|147157168|SUPERIORITY|||||||0.062|||||||Mixed Models Analysis|||||||0.062
73803801|NCT04506463|147157168|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
73803802|NCT04506463|147157168|SUPERIORITY|||||||0.936|||||||Mixed Models Analysis|||||||0.936
73803803|NCT04506463|147157169|SUPERIORITY|||||||0.042|||||||Mixed Models Analysis|||||||0.042
73803804|NCT04506463|147157169|SUPERIORITY|||||||0.037|||||||Mixed Models Analysis|||||||0.037
73803805|NCT04506463|147157169|SUPERIORITY|||||||0.648|||||||Mixed Models Analysis|||||||0.648
73803806|NCT01085630|147157174|SUPERIORITY|||||||0.2423|||||||Fisher Exact|||||||0.2423
73803807|NCT01017874|147157176|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.217|TWO_SIDED|95.0|0.63|1.13|||Wilcoxon (Mann-Whitney)|||||1.13|0.63|0.217
73803808|NCT01017874|147157177|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.788|TWO_SIDED|95.0|0.68|1.31|||Wilcoxon (Mann-Whitney)|||||1.31|0.68|0.788
73803809|NCT01017874|147157180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.252|TWO_SIDED|95.0|0.63|1.14|||Wilcoxon (Mann-Whitney)|||||1.14|0.63|0.252
73803810|NCT01017874|147157181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.952|TWO_SIDED|95.0|0.53|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.53|0.952
73803811|NCT00789373|147157267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||6e-05|TWO_SIDED|95.0|0.49|0.79|||Log Rank|||900 patients were planned to be enrolled in order to randomize 558 pts to maintenance therapy. This trial was powered for the primary endpoint, PFS (90% power, assuming 238 events with 52% censoring and a PFS Hazard Ratio (HR)=0.65, alpha=0.05). This trial was also powered for a secondary endpoint, OS (93% power, assuming 390 events with 30% censoring and an OS HR=0.70). Alpha was controlled for both a preliminary analysis (alpha=0.0001) and final analysis of OS (alpha=0.0499).||0.79|0.49|0.00006
73803812|NCT00789373|147157268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0002|TWO_SIDED|95.0|0.51|0.81|||Log Rank|||||0.81|0.51|0.0002
73803813|NCT00789373|147157269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0195|TWO_SIDED|95.0|0.64|0.96||The predefined alpha for the final analysis of OS is 0.0498 for the unadjusted log-rank test.|Log Rank||Unadjusted HR from Cox model with treatment as the only cofactor.|Type 1 (alpha) error was controlled for the analyses of both PFS and OS in order to maintain an overall two-sided alpha level of 0.05 using a statistical gatekeeping and alpha spending scheme. The unconditional statistical power of the final OS analysis was 93%.||0.96|0.64|0.0195
73803814|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||Adjusted GMT/GMT Ratio based on analysis of covariance (ANCOVA) model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.18|0.87|
73803815|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|0.96|||||TWO_SIDED|95.0|0.82|1.12|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.12|0.82|
73803816|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|0.94|||||TWO_SIDED|95.0|0.81|1.1|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.10|0.81|
73803817|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|0.94|||||TWO_SIDED|95.0|0.77|1.13|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.13|0.77|
73803818|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.32|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.32|0.91|
73803819|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|1.17|||||TWO_SIDED|95.0|0.97|1.41|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.41|0.97|
73803820|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.15|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.15|0.87|
73803821|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|1.09|||||TWO_SIDED|95.0|0.95|1.26|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.26|0.95|
73803822|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.26|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.26|0.95|
73803823|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.09|0.80|
73803824|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|0.91|||||TWO_SIDED|95.0|0.78|1.07|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.07|0.78|
73803825|NCT03321968|147157279|SUPERIORITY||Adjusted GMT Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.15|0.84|
73803826|NCT00232739|147157296|SUPERIORITY_OR_OTHER||Primary analysis posterior probability|0.9926||||||||||The primary analysis of comparing Sirolimus stent with POBA using Bayesian regression model yields that Sirolimus is superior to POBA in reducing the BAR risk.|Bayesian regression model|Multi-level Bayesian regression model was used in the secondary analysis|Secondary analysis for comparing Sirolimus stent with BMS1 and BMS2 signified that Sirolimus stent is superior to POBA, BMS1 and BMS2 in reducing the BAR risk.|Historical control groups consist of propensity-scored matched cohorts (100 patients each, based on Reference Vessel Diameter, lesion length, diabetes, left anterior artery diseased vessel, and gender) of plain old balloon angioplasty (POBA), first generation (Palmaz-Schatz) bare metal stent (BMS1), and BX VELOCITY bare metal stent (BMS2). Study showed the risk of 6-month in-lesion binary angiographic restenosis (BAR) was much lower for the 2.25 Sirolimus stent compared with POBA, BMS1 or BMS2.||||
73803827|NCT00463047|147157312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.18|0.29|||Mixed effects ANOVA|Crossover analysis||The statistical hypothesis to be tested was:HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and oxycodone (OXY), respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.29|0.18|<0.0001
73803828|NCT00463047|147157313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.0081|TWO_SIDED|95.0|0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.05|0.01|0.0081
73803829|NCT00463047|147157314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.05|0.13||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.13|0.05|<0.0001
73803830|NCT00463047|147157315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|0.3|0.45||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.45|0.30|<0.0001
73803831|NCT00463047|147157316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.2|0.35||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.35|0.20|<0.0001
73803832|NCT00463047|147157317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|0.08|0.25||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.25|0.08|<0.0001
73803833|NCT00463047|147157324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|0.39|0.58|||ANOVA|||||0.58|0.39|<0.0001
73803834|NCT00463047|147157325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|0.7|1.16|||ANOVA|||||1.16|0.70|<0.0001
73803835|NCT00463047|147157326|SUPERIORITY_OR_OTHER|||||||0.1966||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.1966
73803836|NCT00463047|147157327|SUPERIORITY_OR_OTHER|||||||0.0275||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0275
73803837|NCT00463047|147157328|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0001
73803838|NCT00463047|147157329|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||<0.0001
73803839|NCT00463047|147157330|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0004
73803840|NCT00463047|147157331|SUPERIORITY_OR_OTHER|||||||0.0074||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0074
73803841|NCT00463047|147157332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|0.55|0.83||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||||0.83|0.55|<0.0001
73803842|NCT00463047|147157334|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5054||||0.3022|TWO_SIDED|95.0|0.7|3.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||3.3|0.7|0.3022
73803843|NCT00463047|147157335|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4042||||0.0268|TWO_SIDED|95.0|1.0|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|1.0|0.0268
73803844|NCT00463047|147157336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4631||||0.0008|TWO_SIDED|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.2|0.0008
73803845|NCT00463047|147157337|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3184||||0.0084|TWO_SIDED|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.1|0.0084
73803846|NCT00463047|147157338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0788||||0.5283|TWO_SIDED|95.0|0.9|1.4|||Generalize estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.9|0.5283
73803847|NCT00463047|147157339|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9491||||0.711|TWO_SIDED|95.0|0.7|1.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.3|0.7|0.7110
73803848|NCT00463047|147157340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5355||||0.3288|TWO_SIDED|95.0|0.2|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|0.2|0.3288
73803849|NCT00463047|147157341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1485||||0.5145|TWO_SIDED|95.0|0.8|1.7|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.7|0.8|0.5145
73803850|NCT00463047|147157342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4481||||0.0191|TWO_SIDED|95.0|1.1|2.0|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.0|1.1|0.0191
73803851|NCT00463047|147157343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4396||||0.0006|TWO_SIDED|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.2|0.0006
73803852|NCT00463047|147157344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3426||||0.0044|TWO_SIDED|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.1|0.0044
73803853|NCT00463047|147157345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1448||||0.2184|TWO_SIDED|95.0|0.9|1.4|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.9|0.2184
73803854|NCT00463047|147157346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9249||||0.5808|TWO_SIDED|95.0|0.7|1.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.2|0.7|0.5808
73803855|NCT00463047|147157347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8908|||<|0.0001|TWO_SIDED|95.0|1.7|2.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||2.2|1.7|<0.0001
73803856|NCT00463047|147157348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5841|||<|0.0001|TWO_SIDED|95.0|1.4|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.8|1.4|<0.0001
73803857|NCT03020992|147157361|OTHER||Rate ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.116|0.281|||Poisson regression|||"The Poisson regression allowed for a comparison of event rates adjusting for differences in time between prestudy/on-study periods.~Event rates were based on a Poisson model with generalized estimating equations and a log-link, including an offset term for time interval length, and with period and disease duration of axSpA (\<2 years/≥2 years) as covariates. A repeated statement was included for participants and assumed an exchangeable correlation structure between prestudy and on-study flares."||0.281|0.116|<0.001
73803858|NCT01006122|147157393|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.747||0.418|TWO_SIDED|80.0|-0.81|1.12|||Mixed Models Analysis|||One sided p-value was based on linear mixed effects model with treatment and period as fixed effects, baseline MWT as a covariate and participant as random effect.||1.12|-0.81|0.418
73803859|NCT01006122|147157394|SUPERIORITY_OR_OTHER||LS Means Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.457||0.054|TWO_SIDED|80.0|-1.32|-0.15|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.15|-1.32|0.054
73803860|NCT01006122|147157394|SUPERIORITY_OR_OTHER||LS Means Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.453||0.247|TWO_SIDED|80.0|-0.89|0.27|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.27|-0.89|0.247
73803861|NCT01006122|147157394|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.457||0.095|TWO_SIDED|80.0|-1.19|-0.01|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.01|-1.19|0.095
73803862|NCT01006122|147157394|SUPERIORITY_OR_OTHER||LS Means Difference|0.13|STANDARD_ERROR_OF_MEAN|0.487||0.604|TWO_SIDED|80.0|-0.5|0.75|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.75|-0.50|0.604
73803863|NCT01006122|147157394|SUPERIORITY_OR_OTHER||LS Means Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.473||0.232|TWO_SIDED|80.0|-0.95|0.26|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.26|-0.95|0.232
73803864|NCT01006122|147157394|SUPERIORITY_OR_OTHER||LS Means Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.473||0.093|TWO_SIDED|80.0|-1.23|-0.02|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.02|-1.23|0.093
73803865|NCT01006122|147157394|SUPERIORITY_OR_OTHER||LS Means Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.498||0.274|TWO_SIDED|80.0|-0.94|0.34|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.34|-0.94|0.274
73803866|NCT01006122|147157395|SUPERIORITY_OR_OTHER||LS Means Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.244||0.121|TWO_SIDED|80.0|-0.6|0.03|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.03|-0.60|0.121
73803867|NCT01006122|147157395|SUPERIORITY_OR_OTHER||LS Means Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.243||0.394|TWO_SIDED|80.0|-0.38|0.25|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.25|-0.38|0.394
73803868|NCT01006122|147157395|SUPERIORITY_OR_OTHER||LS Means Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.244||0.073|TWO_SIDED|80.0|-0.67|-0.04|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||-0.04|-0.67|0.073
73803869|NCT01006122|147157395|SUPERIORITY_OR_OTHER||LS Means Difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.495|TWO_SIDED|80.0|-0.34|0.33|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.33|-0.34|0.495
73803870|NCT01006122|147157395|SUPERIORITY_OR_OTHER||LS Means Difference|0.14|STANDARD_ERROR_OF_MEAN|0.253||0.711|TWO_SIDED|80.0|-0.18|0.46|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.46|-0.18|0.711
73803871|NCT01006122|147157395|SUPERIORITY_OR_OTHER||LS Means Difference|0.18|STANDARD_ERROR_OF_MEAN|0.253||0.767|TWO_SIDED|80.0|-0.14|0.51|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.51|-0.14|0.767
73803872|NCT01006122|147157395|SUPERIORITY_OR_OTHER||LS Means Difference|0.14|STANDARD_ERROR_OF_MEAN|0.266||0.698|TWO_SIDED|80.0|-0.2|0.48|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.48|-0.20|0.698
73803873|NCT01006122|147157398|SUPERIORITY_OR_OTHER||LS Means Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.142||0.127|TWO_SIDED|80.0|-0.34|0.02|||Mixed Models Analysis|||Day 5 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.02|-0.34|0.127
73803874|NCT01006122|147157398|SUPERIORITY_OR_OTHER||LS Means Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.141||0.303|TWO_SIDED|80.0|-0.25|0.11|||Mixed Models Analysis|||Day 10 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.11|-0.25|0.303
73803875|NCT01006122|147157398|SUPERIORITY_OR_OTHER||LS Means Difference|0.09|STANDARD_ERROR_OF_MEAN|0.143||0.738|TWO_SIDED|80.0|-0.09|0.27|||Mixed Models Analysis|||Day 15 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.27|-0.09|0.738
73803876|NCT01006122|147157398|SUPERIORITY_OR_OTHER||LS Means Difference|0.16|STANDARD_ERROR_OF_MEAN|0.152||0.85|TWO_SIDED|80.0|-0.04|0.35|||Mixed Models Analysis|||Day 20 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.35|-0.04|0.850
73803877|NCT01006122|147157398|SUPERIORITY_OR_OTHER||LS Means Difference|0.05|STANDARD_ERROR_OF_MEAN|0.148||0.631|TWO_SIDED|80.0|-0.14|0.24|||Mixed Models Analysis|||Day 7 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.24|-0.14|0.631
73895413|NCT04145219|147324343|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0527|TWO_SIDED|95.0|1.0|3.3|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a SABA free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included SABA free day (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average asthma DSS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a day where a subject with asthma did not use SABA, odds ratio is (odds active/odds Placebo).||3.3|1.0|0.0527
73895414|NCT04145219|147324344|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.1256|TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The endpoint was analysed using a linear mixed effect (LME) model. The model includes the endpoint as response variable, treatment and cohort as fixed factors, the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.0|-0.1|0.1256
73895415|NCT04145219|147324345|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0008|TWO_SIDED|95.0|1.3|2.5|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a rhinitis mild day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included the endpoint (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average rhinitis TCRS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a day with no or mild rhinitis symptoms, odds ratio is (odds 12 SQ-HDM / odds Placebo).||2.5|1.3|0.0008
73895416|NCT04145219|147324346|SUPERIORITY||Odds Ratio (OR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.4|0.7|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a rhinitis exacerbation day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included the endpoint (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average rhinitis DSS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a rhinitis exacerbation day, odds ratio is (odds 12 SQ-HDM / odds Placebo).||0.7|0.4|<0.0001
73895417|NCT04145219|147324347|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.3|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinitis CSMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.3|0.1|<0.0001
73895418|NCT04145219|147324348|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.3|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis CSMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.3|0.1|<0.0001
73895419|NCT02059291|147324354|SUPERIORITY||||||<|0.0001|||||||Fisher's exact test|||||||<0.0001
73895420|NCT02059291|147324354|SUPERIORITY|||||||0.002|||||||Fisher's exact test|||||||0.0020
73895421|NCT02059291|147324354|SUPERIORITY|||||||0.005|||||||Fisher's exact test|||||||0.0050
73895422|NCT02059291|147324355|SUPERIORITY||Odds Ratio (OR)|16.96|||<|0.0001|TWO_SIDED|95.0|4.15|69.21|||Regression, Logistic|||||69.21|4.15|<0.0001
73895423|NCT02059291|147324355|SUPERIORITY||Odds Ratio (OR)|13.63||||0.0006|TWO_SIDED|95.0|2.83|65.59|||Regression, Logistic|||||65.59|2.83|0.0006
73895424|NCT02059291|147324355|SUPERIORITY||Odds Ratio (OR)|23.79||||0.0028|TWO_SIDED|95.0|2.52|224.86|||Regression, Logistic|||||224.86|2.52|0.0028
73803878|NCT01006122|147157398|SUPERIORITY_OR_OTHER||LS Means Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.147||0.16|TWO_SIDED|80.0|-0.34|0.04|||Mixed Models Analysis|||Day 14 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.04|-0.34|0.160
73895425|NCT02059291|147324356|SUPERIORITY||Odds Ratio (OR)|29.78|||<|0.0001|TWO_SIDED|95.0|5.86|151.31|||Regression, Logistic|||||151.31|5.86|<0.0001
73895426|NCT02059291|147324356|SUPERIORITY||Odds Ratio (OR)|12.71||||0.001|TWO_SIDED|95.0|2.53|63.89|||Regression, Logistic|||||63.89|2.53|0.0010
73895427|NCT02059291|147324356|SUPERIORITY||Odds Ratio (OR)|6.64||||0.0149|TWO_SIDED|95.0|1.2|36.57|||Regression, Logistic|||||36.57|1.20|0.0149
73895428|NCT02059291|147324357|SUPERIORITY||Odds Ratio (OR)|17.46||||0.0286|TWO_SIDED|95.0|0.92|332.92|||Regression, Logistic|||||332.92|0.92|0.0286
73895429|NCT02059291|147324357|SUPERIORITY||Odds Ratio (OR)|5.26||||0.0778|TWO_SIDED|95.0|0.53|51.97|||Regression, Logistic|||||51.97|0.53|0.0778
73895430|NCT02059291|147324357|SUPERIORITY||Odds Ratio (OR)|16.69||||0.0235|TWO_SIDED|95.0|1.04|268.5|||Regression, Logistic|||||268.50|1.04|0.0235
73895431|NCT02059291|147324358|SUPERIORITY||Odds Ratio (OR)|8.17||||0.0513|TWO_SIDED|95.0|0.75|113.44|||Regression, Logistic|||||113.44|0.75|0.0513
73895432|NCT02059291|147324358|SUPERIORITY||Odds Ratio (OR)|6.0||||0.2168|TWO_SIDED|95.0|0.27|366.24|||Regression, Logistic|||||366.24|0.27|0.2168
73895433|NCT02059291|147324358|SUPERIORITY||Odds Ratio (OR)|4.5||||0.3571|TWO_SIDED|95.0|0.15|313.49|||Regression, Logistic|||||313.49|0.15|0.3571
73895434|NCT01433289|147324360|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||The study hypothesis tested whether Polyphenon E given twice daily for 14 days at the specified doses has an effect on antiviral activity compared with placebo, measured by differences from baseline to day 14 in plasma HIV-1 RNA level (log10 copies/mL). The Wilcoxon signed-rank test was used to test the null hypothesis that there was no change at Day 14 versus baseline.||||>0.05
73895435|NCT01433289|147324360|SUPERIORITY|||||||0.74||||||Analysis was stratified by treatment group. The Kruskal-Wallis test was used to compare the change of log10 HIV-1 RNA copies/ml between treatment groups.|Kruskal-Wallis|||||||0.74
73895436|NCT04343235|147324364|SUPERIORITY|||||||0.21|||||||Fisher Exact|||||||0.21
73895437|NCT04343235|147324365|SUPERIORITY|||||||0.7||||||Main effect for Randomization group|ANOVA|||||||0.70
73895438|NCT04343235|147324366|SUPERIORITY|||||||0.77|||||||ANOVA|Main effect for randomization group||||||0.77
73895439|NCT04343235|147324367|SUPERIORITY|||||||0.54|||||||ANOVA|Main effect for randomization group||||||0.54
73803879|NCT01006122|147157398|SUPERIORITY_OR_OTHER||LS Means Difference|0.02|STANDARD_ERROR_OF_MEAN|0.156||0.541|TWO_SIDED|80.0|-0.18|0.22|||Mixed Models Analysis|||Day 21 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.22|-0.18|0.541
73803880|NCT02560922|147157410|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.128|TWO_SIDED|95.0|-1.45|0.18|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.18|-1.45|0.128
73803881|NCT02560922|147157410|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.068|TWO_SIDED|95.0|-1.73|0.06|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.06|-1.73|0.068
73803882|NCT02560922|147157411|SUPERIORITY||Mean Difference (Final Values)|-2.62||||0.129|TWO_SIDED|95.0|-6.01|0.77|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.77|-6.01|0.129
73803883|NCT02560922|147157411|SUPERIORITY||Mean Difference (Final Values)|-3.31||||0.084|TWO_SIDED|95.0|-7.07|0.44|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.44|-7.07|0.084
73803884|NCT02560922|147157412|SUPERIORITY||Mean Difference (Final Values)|-1.61||||0.209|TWO_SIDED|95.0|-4.14|0.91|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.91|-4.14|0.209
73803885|NCT02560922|147157412|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.128|TWO_SIDED|95.0|-5.03|0.63|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.63|-5.03|0.128
73803886|NCT02560922|147157413|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.222|TWO_SIDED|95.0|-2.18|0.51|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.51|-2.18|0.222
73803887|NCT02560922|147157413|SUPERIORITY||Mean Difference (Final Values)|-1.14||||0.128|TWO_SIDED|95.0|-2.6|0.33|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.33|-2.60|0.128
73803888|NCT02560922|147157414|SUPERIORITY||Mean Difference (Final Values)|1.71||||0.111|TWO_SIDED|95.0|-0.4|3.82|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||3.82|-0.40|0.111
73803889|NCT02560922|147157414|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.502|TWO_SIDED|95.0|-1.42|2.88|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||2.88|-1.42|0.502
73803890|NCT02560922|147157415|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.433|TWO_SIDED|95.0|-1.15|2.66|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||2.66|-1.15|0.433
73803891|NCT02560922|147157415|SUPERIORITY||Mean Difference (Final Values)|1.71||||0.12|TWO_SIDED|95.0|-0.45|3.86|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||3.86|-0.45|0.120
73803892|NCT02560922|147157416|SUPERIORITY||Mean Difference (Final Values)|15.31||||0.001|TWO_SIDED|95.0|9.09|21.53|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||21.53|9.09|0.001
73803893|NCT02560922|147157416|SUPERIORITY||Mean Difference (Final Values)|11.67|||<|0.001|TWO_SIDED|95.0|5.08|18.27|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||18.27|5.08|<0.001
73803894|NCT02560922|147157417|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.356|TWO_SIDED|95.0|-1.57|0.57|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.57|-1.57|0.356
73803895|NCT02560922|147157417|SUPERIORITY||Mean Difference (Final Values)|-1.02||||0.087|TWO_SIDED|95.0|-2.19|0.15|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.15|-2.19|0.087
73803896|NCT02560922|147157418|SUPERIORITY||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.61|1.41|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||1.41|0.61|<0.001
73803897|NCT02560922|147157418|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.002|TWO_SIDED|95.0|0.24|1.09|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||1.09|0.24|0.002
73803898|NCT02560922|147157419|SUPERIORITY||Mean Difference (Final Values)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.6|-0.95|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 3 months||-0.95|-1.60|<0.001
73803899|NCT02560922|147157419|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.001|TWO_SIDED|95.0|-1.24|-0.51|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 9 months||-0.51|-1.24|<0.001
73803900|NCT03493854|147157420|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8.|Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|1.14|1.31|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of pertuzumab (Arm B) relative to the pertuzumab IV dose (Arm A).|The null hypothesis was that the pertuzumab Arm A SC dose is inferior to the pertuzumab Arm B IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of pertuzumab relative to the IV dose is not greater than 0.8).||1.31|1.14|
73803901|NCT03493854|147157421|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8. Non-inferiority was tested in hierarchical order after the primary outcome measure, to adjust for multiple statistical testing and control the type I error at one sided 5% significance level.|Geometric Mean Ratio|1.33|||||TWO_SIDED|90.0|1.24|1.43|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of trastuzumab (Arm B) relative to the trastuzumab IV dose (Arm A).|The null hypothesis was that the trastuzumab Arm B SC dose is inferior to the Arm A trastuzumab IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of trastuzumab relative to the IV dose is not greater than 0.8).||1.43|1.24|
73803902|NCT03493854|147157422|OTHER|Descriptive analysis only. tpCR was analyzed outside of a hypothesis-testing framework and according to the methodology outlined in the outcome measure description.|Difference in tpCR Rate|0.15|||||TWO_SIDED|95.0|-8.67|8.97|||||Difference in tpCR rate was calculated as Arm B: PH FDC SC minus Arm A: P+H IV.|||8.97|-8.67|
73803903|NCT03493854|147157423|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.2||||0.5216|TWO_SIDED|95.0|0.68|2.11|||Log Rank|||||2.11|0.68|0.5216
73803904|NCT03493854|147157424|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.15||||0.5992|TWO_SIDED|95.0|0.68|1.97|||Log Rank|||||1.97|0.68|0.5992
73803905|NCT03493854|147157425|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.2||||0.4844|TWO_SIDED|95.0|0.72|1.98|||Log Rank|||||1.98|0.72|0.4844
73803906|NCT03493854|147157426|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.16||||0.5474|TWO_SIDED|95.0|0.71|1.88|||Log Rank|||||1.88|0.71|0.5474
73803907|NCT03493854|147157427|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.17||||0.6291|TWO_SIDED|95.0|0.61|2.24|||Log Rank|||||2.24|0.61|0.6291
73803908|NCT03493854|147157428|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.26||||0.5609|TWO_SIDED|95.0|0.58|2.72|||Log Rank|||||2.72|0.58|0.5609
73803909|NCT02105987|147157451|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is -10%.|Mean Difference (Net)|-3.4|||||TWO_SIDED|95.0|-9.1|2.4|||Cochran-Mantel-Haenszel||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).|||2.4|-9.1|
73803910|NCT02105987|147157453|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-2.0|1.4|||Cochran-Mantel-Haenszel||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).|||1.4|-2.0|
73803911|NCT02105987|147157458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.096|TWO_SIDED|95.0|-0.02|0.23|||ANCOVA||Statistical analysis of cholesterol is presented|||0.23|-0.02|0.096
73803912|NCT02105987|147157458|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.07||||0.167|TWO_SIDED|95.0|-0.03|0.18|||ANCOVA||Statistical analysis of LDL cholesterol is presented|||0.18|-0.03|0.167
73803913|NCT02105987|147157458|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.317|TWO_SIDED|95.0|-0.02|0.06|||ANCOVA||Statistical analysis of HDL cholesterol is presented|||0.06|-0.02|0.317
73803914|NCT02105987|147157458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.187|TWO_SIDED|95.0|-0.05|0.27|||ANCOVA||Statistical analysis of triglycerides is presented|||0.27|-0.05|0.187
73803915|NCT02105987|147157459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.175|TWO_SIDED|95.0|-0.04|0.25|||ANCOVA||Statistical analysis of total cholesterol/HDL cholesterol ratio is presented|||0.25|-0.04|0.175
73803916|NCT02105987|147157460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4|||<|0.001|TWO_SIDED|95.0|1.3|3.5|||ANCOVA||Statistical analysis for total score is presented|||3.5|1.3|<0.001
73803917|NCT02105987|147157460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.002|TWO_SIDED|95.0|0.4|1.7|||ANCOVA||Statistical analysis for general satisfaction/clinical subscale score is presented|||1.7|0.4|0.002
73803918|NCT02105987|147157460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|||<|0.001|TWO_SIDED|95.0|0.8|1.8|||ANCOVA||Statistical analysis for lifestyle/ease subscale is presented|||1.8|0.8|<0.001
73803919|NCT02105987|147157461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.51|||<|0.001|TWO_SIDED|95.0|4.86|8.16|||ANCOVA|||||8.16|4.86|<0.001
73803920|NCT02105987|147157462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.87|||<|0.001|TWO_SIDED|95.0|-8.64|-5.11|||ANCOVA|||||-5.11|-8.64|<0.001
73803921|NCT02105987|147157463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||<|0.001|TWO_SIDED|95.0|-0.17|-0.1|||ANCOVA|||||-0.10|-0.17|<0.001
73803922|NCT02105987|147157464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.375|TWO_SIDED|95.0|-0.31|0.12|||ANCOVA|||||0.12|-0.31|0.375
73803923|NCT02105987|147157465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.749|TWO_SIDED|95.0|-0.93|1.3|||ANCOVA|||||1.30|-0.93|0.749
73803924|NCT02105987|147157466|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.82|0.9||Bone specific alkaline phosphatase|ANCOVA|||||0.90|0.82|<0.001
73803925|NCT02105987|147157466|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91||||0.002|TWO_SIDED|95.0|0.85|0.96||Osteocalcin|ANCOVA|||||0.96|0.85|0.002
73803926|NCT02105987|147157466|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|-0.09||||0.001|TWO_SIDED|95.0|-0.15|-0.04||Procollagen 1 n-terminal propeptide|ANCOVA|||||-0.04|-0.15|0.001
73803927|NCT02105987|147157466|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91||||0.001|TWO_SIDED|95.0|0.86|0.96||Type I collagen c-telopeptides|ANCOVA|||||0.96|0.86|0.001
73803928|NCT02105987|147157467|SUPERIORITY_OR_OTHER||Geometric Mean ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.57|0.72||Fatty acid binding protein 2|ANCOVA|||||0.72|0.57|<0.001
73803929|NCT02105987|147157467|SUPERIORITY_OR_OTHER||Geometric Mean ratio|1.08||||0.311|TWO_SIDED|95.0|0.93|1.24||Interleukin 6|ANCOVA|||||1.24|0.93|0.311
73803930|NCT02105987|147157467|SUPERIORITY_OR_OTHER||Geometric Mean ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.89|0.96||Soluble CD14|ANCOVA|||||0.96|0.89|<0.001
73803931|NCT02105987|147157467|SUPERIORITY_OR_OTHER||Geometric Mean ratio|1.01||||0.742|TWO_SIDED|95.0|0.95|1.08||Soluble vasc cell adhesion molecule 1|ANCOVA|||||1.08|0.95|0.742
73803932|NCT02105987|147157468|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0||||0.999|TWO_SIDED|95.0|0.84|1.19|||ANCOVA|||||1.19|0.84|0.999
73803933|NCT02105987|147157469|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0||||0.981|TWO_SIDED|95.0|0.91|1.1|||ANCOVA|||||1.10|0.91|0.981
73803934|NCT02105987|147157470|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97||||0.64|TWO_SIDED|95.0|0.85|1.11|||ANCOVA|||||1.11|0.85|0.640
73803935|NCT02105987|147157471|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97||||0.645|TWO_SIDED|95.0|0.87|1.09|||ANCOVA|||||1.09|0.87|0.645
73803936|NCT02105987|147157472|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01||||0.577|TWO_SIDED|95.0|0.97|1.06|||ANCOVA|||||1.06|0.97|0.577
73803937|NCT02105987|147157473|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01||||0.687|TWO_SIDED|95.0|0.98|1.03|||ANCOVA|||||1.03|0.98|0.687
73803938|NCT02268916|147157478|SUPERIORITY|The study was powered based on a two-sample t-test of the primary outcomes, changes in physical activity or social participant over 6 months. Based on previous literature, in order to detect an effect size of 0.28 with at least 70% power, we aimed to recruit at least 35 participants in each treatment group.|Mean Difference (Final Values)|0.39|||=|0.18|TWO_SIDED|95.0|-0.18|0.97|||Mixed Models Analysis|The outcome was adjusted for time of visit, visit x intervention group, age, gender, body mass index, insulin, depression, and time-up-and-go score.||We hypothesized that at the end of 6 months, the intervention group will have increased physical activity as measured by CHAMPS compared to the control group.||0.97|-0.18|=0.18
73803939|NCT02268916|147157479|SUPERIORITY||Slope|-2.2||||0.19|TWO_SIDED|95.0|-5.45|1.06|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in social roles.||1.06|-5.45|0.19
73803940|NCT02268916|147157479|SUPERIORITY||Slope|-1.02||||0.57|TWO_SIDED|95.0|-4.53|2.48|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in discretionary social activities.||2.48|-4.53|0.57
73803941|NCT02268916|147157479|SUPERIORITY||Slope|-2.44||||0.12|TWO_SIDED|95.0|-5.52|0.63|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by the survey on the ability to participate in social roles and activities.||0.63|-5.52|0.12
73803942|NCT02268916|147157480|SUPERIORITY||Slope|-1.99|||<|0.05|TWO_SIDED|95.0|-3.97|-0.02|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in timed up and go test.||-0.02|-3.97|<0.05
73803943|NCT02268916|147157481|SUPERIORITY||Slope|0.11||||0.02|TWO_SIDED|95.0|0.02|0.2|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in gait speed.||0.20|0.02|0.02
73803944|NCT02268916|147157482|SUPERIORITY||Slope|40.04||||0.02|TWO_SIDED|95.0|7.9|72.17|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in six-minute walk test.||72.17|7.90|0.02
73803945|NCT03926117|147157485|SUPERIORITY||Median Difference (Final Values)|-66.2|||<|0.0001|TWO_SIDED|95.0|-86.15|-49.12|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (greater than or equal to (\>=) 11 or less than (\<) 11 grams per deciliter (g/dL)) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-49.12|-86.15|<0.0001
73803946|NCT03926117|147157485|SUPERIORITY||Median Difference (Final Values)|-77.71|||<|0.0001|TWO_SIDED|95.0|-94.98|-62.97|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (\>= 11 or \< 11 g/dL) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-62.97|-94.98|<0.0001
73803947|NCT03926117|147157485|SUPERIORITY||Median Difference (Final Values)|-87.76|||<|0.0001|TWO_SIDED|95.0|-101.0|-70.54|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (\>= 11 or \< 11 g/dL) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-70.54|-101.00|<0.0001
73803948|NCT00086138|147157509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.52|1.97|||Chi-squared|||The statistical analyses compared data collected from the CGIC of participants who received sertraline who had a score equal to or better than the CGIC of participants who received the placebo intervention.||1.97|0.52|0.98
73803949|NCT00086138|147157510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.11|TWO_SIDED|95.0|0.84|5.04|||Chi-squared|||||5.04|0.84|0.11
73803950|NCT00460811|147157517|SUPERIORITY_OR_OTHER|||||||0.0002|||||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0002
73803951|NCT00460811|147157517|SUPERIORITY_OR_OTHER|||||||0.0036||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0036
73803952|NCT00460811|147157517|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||<0.0001
73803953|NCT00460811|147157517|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0008
73803954|NCT02748356|147157524|OTHER|1 sample t-test|||||=|0.351|||||||t-test, 2 sided|This is a single group comparison||||||=0.351
73803955|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.37|||=|0.002|TWO_SIDED|||||The above p value corresponds to the Mastoid Process left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mastoid Process left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.002
73803956|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.28|||=|0.018|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mastoid Process right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.018
73803957|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.32|||=|0.02|TWO_SIDED|||||The above p value corresponds to the Bladder 10 left (BL 10) algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Bladder 10 left (BL 10) algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.020
73803958|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.39|||=|0.025|TWO_SIDED|||||The above p value corresponds to the Bladder 10 right (BL 10) algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Bladder 10 right (BL 10) algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.025
73895440|NCT04343235|147324368|SUPERIORITY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.0||0.47|TWO_SIDED|95.0|-1.5|3.1|||t-test, 2 sided|||||3.1|-1.5|0.47
73803959|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.55|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Zygapophyseal Joint left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||<0.001
73803960|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.57|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Zygapophyseal Joint right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||<0.001
73803961|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.36|||=|0.139|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Upper Trapezius Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.139
73803962|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.3|||=|0.011|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Upper Trapezius Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.011
73803963|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.67|||=|0.01|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Levator Scapulae Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.010
73803964|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.62|||=|0.06|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Levator Scapulae Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.06
73803965|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.51|||=|0.05|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Deltoid Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.050
73803966|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.41|||=|0.068|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Deltoid Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.068
73803967|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.59|||=|0.049|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Tibialis Anterior Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.049
73803968|NCT05870371|147157544|OTHER||Mean Difference (Net)|0.73|||=|0.004|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Tibialis Anterior Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.004
73803969|NCT05870371|147157544|OTHER||Dependence coefficient (β)|-0.03|STANDARD_ERROR_OF_MEAN|0.03|=|0.297|TWO_SIDED|||||The above p value corresponds to the Mastoid Process left algometric site. The threshold for statistical significance was p \< 0.05. The above value correspond to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mastoid Process left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.297
73895441|NCT04343235|147324369|SUPERIORITY|||||||0.57|||||||Fisher Exact|||||||0.57
73895442|NCT04343235|147324370|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
73895443|NCT01763996|147324371|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.756|TWO_SIDED|95.0|-10.1|13.76||0.05 level of significance|ANOVA|Analysis of variance (ANOVA) model that includes sequence, period, and treatment as fixed factors and subjects within sequence as a random factor.||||13.76|-10.10|0.756
73803970|NCT05870371|147157544|OTHER||Dependence coefficient (β)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|=|0.855|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05. The above value correspond to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mastoid Process right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.855
73803971|NCT05870371|147157544|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.594|TWO_SIDED|||||The above p value corresponds to the Bladder 10 (BL 10) left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Bladder 10 (BL 10) left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.594
73803972|NCT05870371|147157544|OTHER||Dependence coefficient (β)|0.002|STANDARD_ERROR_OF_MEAN|0.02|=|0.929|TWO_SIDED|||||The above p value corresponds to the Bladder 10 (BL 10) right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Bladder 10 (BL 10) right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.929
73803973|NCT05870371|147157544|OTHER||Dependence coefficient (β)|0.002|STANDARD_ERROR_OF_MEAN|0.05|=|0.725|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Zygapophyseal Joint left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.725
73803974|NCT05870371|147157544|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.725|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Zygapophyseal Joint right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.725
73803975|NCT05870371|147157544|OTHER||Dependence coefficient (β)|0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.398|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Upper Trapezius Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.398
73803976|NCT05870371|147157544|OTHER||Dependence coefficient (β)|0.04|STANDARD_ERROR_OF_MEAN|0.03|=|0.186|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Upper Trapezius Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.186
73803977|NCT05870371|147157544|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.833|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Levator Scapulae Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.833
73895444|NCT00275340|147324392|NON_INFERIORITY_OR_EQUIVALENCE|Study was not powered to determine significant group differences; thus trends are reported for p\<0.20.|||||p<|0||95.0|||||t-test, 2 sided|||Mean change scores were computed on domain and summary scores. Mean differences in change scores between groups were computed and t-tests used to detect significant differences.||||p<0.20
73895445|NCT00612105|147324411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.2537|TWO_SIDED|95.0|-1.171|0.312|||ANCOVA|||||0.312|-1.171|0.2537
73803978|NCT05870371|147157544|OTHER||Dependence coefficient (β)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.469|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Levator Scapulae Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.469
73803979|NCT05870371|147157544|OTHER||Dependence coefficient (β)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.399|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Deltoid Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.399
73803980|NCT05870371|147157544|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.752|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Deltoid Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.752
73803981|NCT05870371|147157544|OTHER||Dependence coefficient (β)|-0.07|STANDARD_ERROR_OF_MEAN|0.02|=|0.002|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Tibialis Anterior Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.002
73803982|NCT05870371|147157544|OTHER||Dependence coefficient (β)|-0.07|STANDARD_ERROR_OF_MEAN|0.02|=|0.003|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Tibialis Anterior Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.003
73803983|NCT05870371|147157545|OTHER||Mean Difference (Net)|5.41|||=|0.002|TWO_SIDED|||||The above p value corresponds to the Rotation maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rotation maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.002
73803984|NCT05870371|147157545|OTHER||Mean Difference (Net)|4.92|||=|0.046|TWO_SIDED|||||The above p value corresponds to the Rotation average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rotation average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.046
73803985|NCT05870371|147157545|OTHER||Mean Difference (Net)|3.81|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Lateral Flexion maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||<0.001
73895446|NCT00743106|147324436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.15|TWO_SIDED|95.0|-31.0|9.0|||Wilcoxon (Mann-Whitney)||The mean decrease in GFR was an estimated 11% less for fenoldopam than for placebo (interim-adjusted 95% confidence interval 9% more, 31% less).|||9|-31|0.15
73895447|NCT00743106|147324437|SUPERIORITY||ratio of geometric mean|0.98||||0.78|TWO_SIDED|95.0|0.79|1.19|||Mixed Models Analysis|||We assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on PODs 1-4). A linear mixed effects model was used to assess the main effect of fenoldopam on the postoperative log-transformed (base 2) serum creatinine, adjusting for baseline serum creatinine.||1.19|0.79|0.78
73895448|NCT02874144|147324457|SUPERIORITY|intention-to-treat with participants analyzed according to a randomly assigned treatment group irrespective of compliance.|Slope|0.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED|||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Regression, Linear|||We used baseline scores to track change to follow-up scores and used a difference-in-differences (D-I-D) statistical approach to compare the change over time compare relative rate of change over time between scores within the treatment group (AZD1981 plus INCS) and within the to scores within the placebo group (INCS treatment only)..|For inflammatory mediator analyses, data were reported as mean (SEM) with statistical significance determined by Kruskal-Wallis test.|||<0.05
73803986|NCT05870371|147157545|OTHER||Mean Difference (Net)|3.57|||=|0.043|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Lateral Flexion average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.043
73803987|NCT05870371|147157545|OTHER||Mean Difference (Net)|4.52|||=|0.018|TWO_SIDED|||||The above p value corresponds to the Flexion maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Flexion maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.018
73803988|NCT05870371|147157545|OTHER||Mean Difference (Net)|4.45|||=|0.102|TWO_SIDED|||||The above p value corresponds to the Flexion average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Flexion average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.102
73803989|NCT05870371|147157545|OTHER||Mean Difference (Net)|5.85|||=|0.16|TWO_SIDED|||||The above p value corresponds to the Extension maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Extension maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.160
73803990|NCT05870371|147157545|OTHER||Mean Difference (Net)|5.48|||<|0.039|TWO_SIDED|||||The above p value corresponds to the Extension average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Extension average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||<0.039
73803991|NCT05870371|147157545|OTHER||Dependence coefficient (β)|-5.0|STANDARD_ERROR_OF_MEAN|1.51|=|0.001|TWO_SIDED|||||The above p-value corresponds to the Rotation maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rotation maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.001
73803992|NCT05870371|147157545|OTHER||Dependence coefficient (β)|-5.0|STANDARD_ERROR_OF_MEAN|1.51|=|0.002|TWO_SIDED||||||Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rotation average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.002
73803993|NCT05870371|147157545|OTHER||Dependence coefficient (β)|-4.84|STANDARD_ERROR_OF_MEAN|1.6|=|0.048|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Lateral Flexion maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.048
73803994|NCT05870371|147157545|OTHER||Dependence coefficient (β)|-2.0|STANDARD_ERROR_OF_MEAN|1.06|=|0.059|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Lateral Flexion average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.059
73803995|NCT05870371|147157545|OTHER||Dependence coefficient (β)|-0.92|STANDARD_ERROR_OF_MEAN|1.62|=|0.57|TWO_SIDED|||||The above p value corresponds to the Flexion maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Flexion maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.57
73803996|NCT05870371|147157545|OTHER||Dependence coefficient (β)|-0.14|STANDARD_ERROR_OF_MEAN|1.65|=|0.931|TWO_SIDED|||||The above p value corresponds to the Flexion average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Flexion average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.931
73803997|NCT05870371|147157545|OTHER||Dependence coefficient (β)|-1.17|STANDARD_ERROR_OF_MEAN|1.99|=|0.558|TWO_SIDED|||||The above p value corresponds to the Extension maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Extension maximum . The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.558
73803998|NCT05870371|147157545|OTHER||Dependence coefficient (β)|-0.03|STANDARD_ERROR_OF_MEAN|1.96|=|0.989|TWO_SIDED|||||The above p value corresponds to the Extension average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Extension average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.989
73803999|NCT05870371|147157546|OTHER||Mean Difference (Net)|1.37|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null hypothesis: The application of ATM does not affect the strength of deep neck flexor muscles as measured by the Chattanooga Stabilizer Pressure Biofeedback in patients with chronic pain in the cervical spine (secondary hypothesis).||||<0.001
73804000|NCT05870371|147157546|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.01|=|0.437|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of applying ATM does not differ in improving the strength of deep neck flexor muscles measured by the Chattanooga Stabilizer Pressure Biofeedback in patients with chronic neck pain than applying A-S (secondary hypothesis).||||=0.437
73804001|NCT05870371|147157547|OTHER||Mean Difference (Net)|0.02|||=|0.919|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.919
73804002|NCT05870371|147157547|OTHER||Dependence coefficients (β)|-0.05|STANDARD_ERROR_OF_MEAN|0.02|=|0.01|TWO_SIDED|||||The above value corresponds to the comparison between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||The above value corresponds to the comparison between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.010
73804003|NCT05870371|147157548|OTHER||Mean Difference (Net)|0.09|||=|0.659|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.659
73804004|NCT05870371|147157548|OTHER||Dependence coefficient (β)|-0.04|STANDARD_ERROR_OF_MEAN|0.02|=|0.05|TWO_SIDED|||||The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.05
73804005|NCT05870371|147157549|OTHER||Mean Difference (Net)|10.28|||=|0.09|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.09
73804006|NCT05870371|147157549|OTHER||Dependence coefficient (β)|-0.06|STANDARD_ERROR_OF_MEAN|0.02|=|0.005|TWO_SIDED|||||The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.005
73804007|NCT05870371|147157550|OTHER||Mean Difference (Net)|-7.87|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Total McGill Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Total McGill Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73804008|NCT05870371|147157550|OTHER||Mean Difference (Net)|-5.55|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Sensory Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Sensory Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73804009|NCT05870371|147157550|OTHER||Mean Difference (Net)|-2.33|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Affective Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Affective Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73804010|NCT05870371|147157550|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.996|TWO_SIDED|||||The above p-value corresponds to the Total McGill score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.996
73804011|NCT05870371|147157550|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.968|TWO_SIDED|||||The above p-value corresponds to the Sensory Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.968
73804012|NCT05870371|147157550|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.854|TWO_SIDED|||||The above p-value corresponds to the Affective Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.854
73804013|NCT05870371|147157551|OTHER||Mean Difference (Net)|-2.59|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||||||<0.001
73804014|NCT05870371|147157551|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.952|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|||||=0.952
73804015|NCT05870371|147157552|OTHER||Mean Difference (Net)|-1.06|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.||||||<0.001
73804016|NCT05870371|147157552|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.989|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|||||=0.989
73804017|NCT05870371|147157553|OTHER||Mean Difference (Net)|-5.6|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the functionality recorded with the Neck Disability Index (NDI) in patients with chronic pain in the cervical spine (secondary hypothesis).||||<0.001
73804018|NCT05870371|147157553|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.973|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of functionality recorded with the Neck Disability Index (NDI) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.973
73804019|NCT05870371|147157554|OTHER||Mean Difference (Net)|-2.11|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Depression subscale of HADS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above value corresponds to the Depression subscale of HADS.|Null Hypothesis: The application of ATM does not affect the anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73804020|NCT05870371|147157554|OTHER||Mean Difference (Net)|-2.05|||<|0.001|TWO_SIDED|||||The above value corresponds to the Anxiety subscale of HADS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above value corresponds to the Anxiety subscale of HADS.|Null Hypothesis: The application of ATM does not affect the anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73804021|NCT05870371|147157554|OTHER||Dependence coefficient (β)|0.04|STANDARD_ERROR_OF_MEAN|0.04|=|0.305|TWO_SIDED|||||The above p-value corresponds to the Depression subscale of HADS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Depression subscale of HADS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.305
73895449|NCT02874144|147324457|SUPERIORITY|This was a superiority trial. We used repeated-measures linear regression using the mixed procedure to calculate means for each outcome by visits and treatment status. We used baseline scores to track change to follow-up scores and used a difference-in-differences (D-I-D) statistical approach to compare the change over time between scores within the treatment group (AZD1981 plus INCS) to scores within the placebo group (INCS treatment only).|Mean Difference (Final Values)|-20.0|||<|0.05|TWO_SIDED|||||No, the p-value was not adjusted for multiple comparisons.|repeated-measures linear regression|We used repeated-measures linear regression using the MIXED procedure to calculate means (SEMS) for each outcome by visits and treatment status.|Our study did not include at relative risk.|The trial design is a continuous outcome superiority trial with primary efficacy outcome measures of change in Total Polyp Score (TPS) comparing AZD to placebo arm from V1 to V5. Total polyp score is a standardized method for assessing nasal polyp size by endoscopy, based on a scale of 1-4 per side. Inclusion criterion for this study is a TPS of ≥4 with a maximum of 8 and a standard deviation ± 2. A clinically meaningful effect is considered to be a decrease in total polyp score of 1.5.||||<0.05
73895450|NCT02975557|147324479|OTHER|||||||1|||||||Fisher Exact|The type I error was adjusted by using the alpha spending function approach with O'Brien-Fleming type boundaries.||We evaluated if the categorical type of tolerability measure is different between control (Artificial Tears) and intervention (Brimonidine, including both 0.15% high and 0.075% low doses groups).||||1
73895451|NCT01578850|147324486|SUPERIORITY_OR_OTHER||Difference in Proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).|Participants who took rescue therapy had the final value taken before rescue used for analysis at all ensuing time points.|||35.81|16.78|<0.001
73895452|NCT01578850|147324487|SUPERIORITY_OR_OTHER||Difference in proportions|23.7||||0.019|TWO_SIDED|95.0|6.83|40.61|||Cochran-Mantel-Haenszel|The p-value from CMH test of general association was stratified by geographic region.||||40.61|6.83|0.019
73895453|NCT01578850|147324489|SUPERIORITY_OR_OTHER||Difference in proportions|-0.6||||0.371|TWO_SIDED|95.0|-1.76|0.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Baseline||0.57|-1.76|0.371
73895454|NCT01578850|147324489|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Baseline||1.81|-0.59|0.358
73895455|NCT01578850|147324489|SUPERIORITY_OR_OTHER||Difference in proportions|2.6||||0.667|TWO_SIDED|95.0|-4.76|9.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 24||9.98|-4.76|0.667
73895456|NCT01578850|147324489|SUPERIORITY_OR_OTHER||Difference in proportions|21.5||||0.001|TWO_SIDED|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||32.02|10.99|0.001
73895457|NCT01578850|147324489|SUPERIORITY_OR_OTHER||Difference in proportions|19.0||||0.004|TWO_SIDED|95.0|8.81|29.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||29.10|8.81|0.004
73895458|NCT01578850|147324489|SUPERIORITY_OR_OTHER||Difference in proportions|30.8|||<|0.001|TWO_SIDED|95.0|20.79|40.83|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||40.83|20.79|<0.001
73895459|NCT01578850|147324489|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.89|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||37.54|16.89|<0.001
73895460|NCT01578850|147324489|SUPERIORITY_OR_OTHER||Difference in proportions|31.3|||<|0.001|TWO_SIDED|95.0|21.51|41.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||41.08|21.51|<0.001
73804022|NCT05870371|147157554|OTHER||Dependence coefficient (β)|0.05|STANDARD_ERROR_OF_MEAN|0.03|=|0.137|TWO_SIDED|||||The above p-value corresponds to the Anxiety subscale of HADS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above values correspond to the Anxiety subscale of HADS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.137
73804023|NCT05870371|147157555|OTHER||Mean Difference (Net)|-3.82|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the kinesiophobia as measured by the Tampa Scale Kinesiophobia (TSK\_GR) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73895461|NCT01578850|147324489|SUPERIORITY_OR_OTHER||Difference in proportions|30.2|||<|0.001|TWO_SIDED|95.0|19.95|40.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||40.47|19.95|<0.001
73804024|NCT05870371|147157555|OTHER||Dependence coefficient (β)|0.02|STANDARD_ERROR_OF_MEAN|0.01|=|0.151|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing kinesiophobia measured by the Tampa Scale Kinesiophobia (TSK\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.151
73804025|NCT05870371|147157555|OTHER||||||=|0.021||||||The threshold for statistical significance was p \< 0.05.|McNemar|||||||=0.021
73804026|NCT05870371|147157556|OTHER||Mean Difference (Net)|-4.24|||=|0.006|TWO_SIDED|||||The above p-value corresponds to the FABQ\_physical subscale. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the FABQ\_physical subscale.|Null Hypothesis: The application of ATM does not affect the perception of the fear and the effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.006
73804027|NCT05870371|147157556|OTHER||Mean Difference (Net)|-2.24|||=|0.001|TWO_SIDED|||||The above p-value corresponds to the FABQ\_work subscale. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the FABQ\_work subscale.|Null Hypothesis: The application of ATM does not affect the perception of the fear and the effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.001
73804028|NCT05870371|147157556|OTHER||Dependence coefficient (β)|0.1|STANDARD_ERROR_OF_MEAN|0.07|=|0.197|TWO_SIDED|||||The above p-value corresponds to the FABQ\_work subscale. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the FABQ\_work subscale. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of perception of fear and effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.197
73804029|NCT05870371|147157556|OTHER||Dependence coefficient (β)|0.07|STANDARD_ERROR_OF_MEAN|0.04|=|0.066|TWO_SIDED|||||The above p-value corresponds to the FABQ\_physical subscale. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the FABQ\_physical subscale. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of perception of fear and effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.066
73804030|NCT05870371|147157557|OTHER||Mean Difference (Net)|-7.07|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Total PCS score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Total PCS score.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73804031|NCT05870371|147157557|OTHER||Mean Difference (Net)|-2.02|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Rumination subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rumination subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73804032|NCT05870371|147157557|OTHER||Mean Difference (Net)|-1.66|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Magnification subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Magnification subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73804033|NCT05870371|147157557|OTHER||Mean Difference (Net)|-3.39|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Helplessness subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Helplessness subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73804034|NCT05870371|147157557|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.871|TWO_SIDED|||||The above p-value corresponds to the Total PCS score. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Total PCS score. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).|The above values correspond to the comparison which is between groups at baseline.|||=0.871
73804035|NCT05870371|147157557|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|=|0.887|TWO_SIDED|||||The above p-value corresponds to the Rumination subscale of PCS. The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rumination subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.887
73895462|NCT01578850|147324489|SUPERIORITY_OR_OTHER||Difference in proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||35.81|16.78|<0.001
73895463|NCT01578850|147324489|SUPERIORITY_OR_OTHER||Difference in proportions|27.1|||<|0.001|TWO_SIDED|95.0|16.67|37.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||37.47|16.67|<0.001
73804036|NCT05870371|147157557|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.879|TWO_SIDED|||||The above p-value corresponds to the Magnification subscale of PCS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Magnification subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.879
73804037|NCT05870371|147157557|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.961|TWO_SIDED|||||The above p-value corresponds to the Helplessness subscale of PCS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Helplessness subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.961
73804038|NCT05870371|147157558|OTHER||Mean Difference (Net)|4.99|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Physical Component Summary/PCS subscale of SF-12. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Physical Component Summary/PCS subscale of SF-12.|Null Hypothesis: The application of ATM does not affect the quality of life as measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73804039|NCT05870371|147157558|OTHER||Mean Difference (Net)|8.33|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Mental Component Summary/MCS subscale of SF-12. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mental Component Summary/MCS subscale of SF-12.|Null Hypothesis: The application of ATM does not affect the quality of life as measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic neck pain (secondary hypothesis).||||<0.001
73804040|NCT05870371|147157558|OTHER||Dependence coefficient (β)|-0.76|STANDARD_ERROR_OF_MEAN|1.32|=|0.564|TWO_SIDED|||||The above p-value corresponds to the Physical Component Summary/PCS of SF-12. The above p-value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Physical Component Summary/PCS subscale of SF-12. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of quality of life measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.564
73804041|NCT05870371|147157558|OTHER||Dependence coefficient (β)|-3.05|STANDARD_ERROR_OF_MEAN|1.34|=|0.023|TWO_SIDED|||||The above p-value corresponds to Mental Component Summary/MCS of SF-12. The above p-value corresponds to the comparison which is between groups at baseline.The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mental Component Summary/MCS of SF-12. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of quality of life measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.023
73804042|NCT05870371|147157559|OTHER||||||=|0.014||||||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||=0.014
73804043|NCT05870371|147157559|OTHER||Median Difference (Net)|1.0|||||TWO_SIDED|||||||||||||
73804044|NCT05870371|147157559|OTHER||Median Difference (Net)|2.0|||||TWO_SIDED|||||||||||||
73804045|NCT02907177|147157584|SUPERIORITY||Treatment effect (rate ratio)|1.27||||0.5252|TWO_SIDED|95.0|0.608|2.654|||Negative binomial regression||Rate ratio is ponesimod 20 mg / DMF versus placebo /DMF|||2.654|0.608|0.5252
73804046|NCT01537042|147157603|SUPERIORITY_OR_OTHER||Treatment Ratio|0.44||||0.0232|TWO_SIDED|95.0|0.22|0.88|||ANCOVA|An analysis of covariance (ANCOVA) was performed for the log-transformed PLMI ratio with treatment and region as factors and Baseline as a covariate.||||0.88|0.22|0.0232
73804047|NCT02151851|147157618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.899|||<|0.001|TWO_SIDED|95.0|2.382|6.382||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||6.382|2.382|<0.001
73804048|NCT02151851|147157619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.641|||<|0.001|TWO_SIDED|95.0|3.57|16.352||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||16.352|3.570|<0.001
73804049|NCT02151851|147157620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.248|||<|0.001|TWO_SIDED|95.0|2.209|23.786||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||23.786|2.209|<0.001
73804050|NCT01540487|147157622|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.5|||||TWO_SIDED|90.0|94.7|104.5|||ANOVA|||||104.5|94.7|
73804051|NCT01540487|147157622|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.8|||||TWO_SIDED|90.0|95.1|106.8|||ANOVA|||||106.8|95.1|
73804052|NCT01540487|147157623|SUPERIORITY_OR_OTHER||adjusted gMean ratio|101.9|||||TWO_SIDED|90.0|95.4|109.0|||ANOVA|||||109.0|95.4|
73895464|NCT01578850|147324491|SUPERIORITY_OR_OTHER||Difference in proportions|1.3||||0.774|TWO_SIDED|95.0|-9.03|11.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 24||11.68|-9.03|0.774
73804053|NCT01540487|147157623|SUPERIORITY_OR_OTHER||adjusted gMean ratio|111.4|||||TWO_SIDED|90.0|100.4|123.5|||ANOVA|||||123.5|100.4|
73804054|NCT01540487|147157624|SUPERIORITY_OR_OTHER||adjusted gMean ratio|97.0|||||TWO_SIDED|90.0|90.6|103.8|||ANOVA|||||103.8|90.6|
73804055|NCT01540487|147157624|SUPERIORITY_OR_OTHER||adjusteg gMean ratio|103.0|||||TWO_SIDED|90.0|96.2|110.1|||ANOVA|||||110.1|96.2|
73804056|NCT01540487|147157625|SUPERIORITY_OR_OTHER||adjusted gMean ratio|94.6|||||TWO_SIDED|90.0|85.4|104.8|||ANOVA|||||104.8|85.4|
73804057|NCT01540487|147157625|SUPERIORITY_OR_OTHER||adjusted gMean ratio|102.5|||||TWO_SIDED|90.0|92.2|113.9|||ANOVA|||||113.9|92.2|
73804058|NCT01540487|147157626|SUPERIORITY_OR_OTHER||adjusted gMean ratio|110.1|||||TWO_SIDED|90.0|100.5|120.6|||ANOVA|||||120.6|100.5|
73804059|NCT01540487|147157626|SUPERIORITY_OR_OTHER||adjusted gMean ratio|89.3|||||TWO_SIDED|90.0|80.2|99.3|||ANOVA|||||99.3|80.2|
73804060|NCT01540487|147157627|SUPERIORITY_OR_OTHER||adjusted gMean ratio|98.0|||||TWO_SIDED|90.0|92.0|104.5|||ANOVA|||||104.5|92.0|
73804061|NCT01540487|147157627|SUPERIORITY_OR_OTHER||adjusted gMean ratio|102.8|||||TWO_SIDED|90.0|97.0|109.0|||ANOVA|||||109.0|97.0|
73804062|NCT01540487|147157628|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.5|||||TWO_SIDED|90.0|94.7|104.6|||ANOVA|||||104.6|94.7|
73804063|NCT01540487|147157628|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.8|||||TWO_SIDED|90.0|95.1|106.8|||ANOVA|||||106.8|95.1|
73804064|NCT01256164|147157629|NON_INFERIORITY_OR_EQUIVALENCE|With 90 subjects, randomized on a 2:1 ratio into the Fibrocaps plus gelatin sponge active arm or the gelatin sponge arm, and assuming a mean TTH of 3.5 minutes with a standard deviation of 2.5 minutes in the active arm and a mean TTH of 6 minutes in the control arm, this translates in a power of 99.4% at a two-sided significance level alpha of 5%, using a two-sample t-test.|||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73804065|NCT01256164|147157630|SUPERIORITY_OR_OTHER|||||||1||95.0|||||t-test, 2 sided|||||||1.00
73804066|NCT01256164|147157631|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||Intent-to-treat analysis||||<0.001
73804067|NCT01256164|147157632|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||intent-to- treat analysis||||0.001
73804068|NCT01256164|147157633|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||intent-to-treat analysis||||0.003
73804069|NCT03503370|147157634|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.39|1.8|||||Hazard ratio from Cox Proportional Hazard comparing the chlorhexidine group to the placebo group.|||1.80|0.39|
73804070|NCT03503370|147157635|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
73804071|NCT03503370|147157636|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.34|1.77|||||Hazard ratio from Cox Proportional Hazard comparing the chlorhexidine group to the placebo group.|||1.77|0.34|
73804072|NCT01598064|147157656|SUPERIORITY_OR_OTHER|||||||0.25|||||||Chi-squared|||||||0.25
73804073|NCT05253573|147157658|SUPERIORITY||Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|1.21|2.83||||||The overall number of participants analyzed reflects the cancer survivors and/or independent caregivers. Participants are not represented separately (as cancer survivors or caregivers) for each Arm. This is because the originally proposed statistical data analysis plan did not aim to analyze the data by each group of caregivers versus cancer patients/survivors (because the statistical power would be very low for doing so||2.83|1.21|
73804074|NCT01436370|147157664|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain.||||0.145
73804075|NCT01436370|147157664|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain||||0.145
73804076|NCT01436370|147157664|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.||||0.999
73804077|NCT01436370|147157672|SUPERIORITY_OR_OTHER|||||||0.182|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain||||0.182
73804078|NCT01436370|147157672|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain.||||0.500
73804079|NCT01436370|147157672|SUPERIORITY_OR_OTHER|||||||0.087|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.||||0.087
73804080|NCT01436370|147157673|SUPERIORITY_OR_OTHER|||||||0.234|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 7.||||0.234
73804081|NCT01436370|147157673|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 180.||||0.250
73804082|NCT01436370|147157673|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 7.||||0.145
73804083|NCT01436370|147157673|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 180.||||0.500
73804084|NCT01436370|147157673|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.||||0.999
73804085|NCT01436370|147157673|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.||||0.500
73804086|NCT01436370|147157674|SUPERIORITY_OR_OTHER|||||||0.716|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 7.||||0.716
73804087|NCT01436370|147157674|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 180.||||0.999
73804088|NCT01436370|147157674|SUPERIORITY_OR_OTHER|||||||0.503|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 7.||||0.503
73804089|NCT01436370|147157674|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 180.||||0.475
73804090|NCT01436370|147157674|SUPERIORITY_OR_OTHER|||||||0.182|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.||||0.182
73804091|NCT01436370|147157674|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.||||0.014
73804092|NCT01436370|147157676|SUPERIORITY_OR_OTHER|||||||0.317|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.||||0.317
73804093|NCT01436370|147157676|SUPERIORITY_OR_OTHER|||||||0.564|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.||||0.564
73804094|NCT01436370|147157676|SUPERIORITY_OR_OTHER|||||||0.999|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.999
73804095|NCT01436370|147157676|SUPERIORITY_OR_OTHER|||||||0.564|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.||||0.564
73804096|NCT01436370|147157676|SUPERIORITY_OR_OTHER|||||||0.999|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.||||0.999
73804097|NCT01436370|147157676|SUPERIORITY_OR_OTHER|||||||0.655|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.655
73804098|NCT01436370|147157677|SUPERIORITY_OR_OTHER|||||||0.18|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21.||||0.180
73804099|NCT01436370|147157677|SUPERIORITY_OR_OTHER|||||||0.763|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.||||0.763
73804100|NCT01436370|147157677|SUPERIORITY_OR_OTHER|||||||0.096|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.096
73804101|NCT01436370|147157677|SUPERIORITY_OR_OTHER|||||||0.157|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21||||0.157
73804102|NCT01436370|147157677|SUPERIORITY_OR_OTHER|||||||0.705|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.||||0.705
73804103|NCT01436370|147157677|SUPERIORITY_OR_OTHER|||||||0.132|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.132
73804104|NCT01754129|147157681|OTHER||||||<|0.001||||||Missing values were replaced using the Last Observation Carried Forward (LOCF) technique for data of questionnaires. Missing data at Visit 3 was replaced with the (non-missing) data recorded at Visit 2.|Paired t-test|||Mean change from baseline to Visit 3||||<0.001
73804105|NCT01754129|147157681|OTHER||||||<|0.001|||||||Paired t-test|||Change from baseline to Visit 2||||<0.001
73804106|NCT04229095|147157711|SUPERIORITY||Slope|-4.58|STANDARD_ERROR_OF_MEAN|1.82||0.007|ONE_SIDED|95.0||-1.01|||Mixed Models Analysis||The effect of the drug on lowering VAS was limited to individuals with impaired sleep at baseline (PSQI \> or = to 5).|Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictors were drug condition, and baseline sleep disturbance (Pittsburgh Sleep Quality Index {PSQI} total score less than 5 or 5 and greater). Arms were combined for this analysis.||-1.01||.007
73804107|NCT04229095|147157713|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.54||0.0025|ONE_SIDED|95.0||-0.46|||Mixed Models Analysis|||Mixed effect model with directional hypothesis that drug reduces number of drinks per day. Principle predictors were drug condition and sex. Arms were combined for this analysis.||-0.46||.0025
73804108|NCT01780038|147157715|OTHER||||||||||||||||||Frequencies and percentages were used to determine this secondary outcome.|||
73804109|NCT01237041|147157716|SUPERIORITY|Univariate ANOVA||||||0.016||||||A priori threshold p\<0.05|ANOVA|Comparison of 3 dose-finding groups. Post-hoc comparisons between groups also done.||ANOVA to compare AUC of GH among groups||||.016
73804110|NCT01237041|147157717|SUPERIORITY|ANOVA of the 3 dose-finding groups. Data transformed using log(10) for analysis||||||0.043||||||A priori threshold for significance p\<0.05|ANOVA|||Analysis of FFA Area Under Curve in dose-finding studies. Data were log-transformed before analysis.||||.043
73804111|NCT01237041|147157718|SUPERIORITY|||||||0.543|||||||ANOVA|||ANOVA, 3 dose-finding groups||||0.543
73804112|NCT01237041|147157719|SUPERIORITY|||||||0.113|||||||ANOVA|||ANOVA, 2 groups, essentially an unpaired t-test.||||.113
73804113|NCT02877004|147157747|SUPERIORITY|||||||0.723|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate.||||||0.723
73804114|NCT02877004|147157748|SUPERIORITY|||||||0.368|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate||||||.368
73804115|NCT01790984|147157812|OTHER||General linear mixed model|2.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing differences between 2 Groups on 2 Diets (NAFLD, Control,high \& low sugar diets).|Details of our statistical approach are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TAG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
73804116|NCT01790984|147157813|OTHER||General linear mixed model|11.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size for NAFLD \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B and triacylglycerol production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level) produced sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
73895465|NCT01578850|147324491|SUPERIORITY_OR_OTHER||Difference in proportions|12.3||||0.034|TWO_SIDED|95.0|2.86|21.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||21.69|2.86|0.034
73895466|NCT01578850|147324491|SUPERIORITY_OR_OTHER||Difference in proportions|16.9||||0.02|TWO_SIDED|95.0|6.33|27.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||27.54|6.33|0.020
73804117|NCT01790984|147157814|OTHER||General linear mixed model|110.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
73804118|NCT01790984|147157815|OTHER||General linear mixed model|0.26|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical approach are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
73804119|NCT01790984|147157816|OTHER||General linear mixed model|10.0|||>|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables|Details of our statistical analyses are described below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||>0.05
73804120|NCT01790984|147157817|OTHER||General linear mixed model|0.28|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
73804121|NCT01691560|147157855|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09||||0.4553|TWO_SIDED|95.0|-0.14|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.32|-0.14|0.4553
73895467|NCT01578850|147324491|SUPERIORITY_OR_OTHER||Difference in proportions|14.6||||0.007|TWO_SIDED|95.0|5.48|23.8|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||23.80|5.48|0.007
73895468|NCT01578850|147324491|SUPERIORITY_OR_OTHER||Difference in proportions|24.9|||<|0.001|TWO_SIDED|95.0|14.72|34.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||34.98|14.72|<0.001
73804122|NCT01691560|147157855|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07||||0.5689|TWO_SIDED|95.0|-0.16|0.3|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.30|-0.16|0.5689
73804123|NCT01691560|147157855|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04||||0.7517|TWO_SIDED|95.0|-0.2|0.27|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.27|-0.20|0.7517
73804124|NCT01691560|147157855|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02||||0.8549|TWO_SIDED|95.0|-0.21|0.25|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.25|-0.21|0.8549
73804125|NCT01691560|147157855|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05||||0.6685|TWO_SIDED|95.0|-0.18|0.29|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.29|-0.18|0.6685
73804126|NCT01691560|147157855|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03||||0.8031|TWO_SIDED|95.0|-0.26|0.2|||ANCOVA||Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.26|0.8031
73804127|NCT01691560|147157856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0467|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.0467
73804128|NCT01691560|147157856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1133|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.1133
73804129|NCT01691560|147157856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2579||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.2579
73804130|NCT01691560|147157856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.6149|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|0|0.6149
73804131|NCT01691560|147157856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3259|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.3259
73804132|NCT01691560|147157856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5721|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|0|0.5721
73804133|NCT01691560|147157857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.36||||0.0292|TWO_SIDED|95.0|0.04|0.69|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.69|0.04|0.0292
73804134|NCT01691560|147157857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12||||0.4484|TWO_SIDED|95.0|-0.44|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.44|0.4484
73804135|NCT01691560|147157857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12||||0.4537|TWO_SIDED|95.0|-0.45|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.45|0.4537
73804136|NCT01691560|147157857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49||||0.0037|TWO_SIDED|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.81|0.16|0.0037
73804137|NCT01691560|147157857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.48||||0.004|TWO_SIDED|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Treatment as fixed factor, baseline Schiff score as covariate. Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.81|0.16|0.0040
73804138|NCT01691560|147157857|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9974|TWO_SIDED|95.0|-0.32|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.32|-0.32|0.9974
73804139|NCT01691560|147157858|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8861|TWO_SIDED|95.0|-5.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|-5|0.8861
73804140|NCT01691560|147157858|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0641|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.0641
73804141|NCT01691560|147157858|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1831||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.1831
73804142|NCT01691560|147157858|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0871|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-10|0.0871
73804143|NCT01691560|147157858|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.169|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-10|0.1690
73804144|NCT01691560|147157858|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3829|TWO_SIDED|95.0|-5.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-5|0.3829
73804145|NCT01691560|147157859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03||||0.9421|TWO_SIDED|95.0|-0.74|0.8|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.80|-0.74|0.9421
73804146|NCT01691560|147157859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15||||0.6918|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.60|-0.90|0.6918
73804147|NCT01691560|147157859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.13||||0.7421|TWO_SIDED|95.0|-0.63|0.88|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.88|-0.63|0.7421
73804148|NCT01691560|147157859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18||||0.6433|TWO_SIDED|95.0|-0.58|0.94|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.94|-0.58|0.6433
73804149|NCT01691560|147157859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1||||0.801|TWO_SIDED|95.0|-0.86|0.67|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.67|-0.86|0.8010
73804150|NCT01691560|147157859|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.28||||0.4692|TWO_SIDED|95.0|-0.48|1.03|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.03|-0.48|0.4692
73804151|NCT01691560|147157860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.31||||0.4797|TWO_SIDED|95.0|-0.55|1.16|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.16|-0.55|0.4797
73804152|NCT01691560|147157860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.54||||0.2023|TWO_SIDED|95.0|-1.37|0.29|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.29|-1.37|0.2023
73804153|NCT01691560|147157860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45||||0.2917|TWO_SIDED|95.0|-1.29|0.39|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.39|-1.29|0.2917
73804154|NCT01691560|147157860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.85||||0.0503|TWO_SIDED|95.0|0.0|1.69|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.69|0.00|0.0503
73804155|NCT01691560|147157860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.76||||0.0811|TWO_SIDED|95.0|-0.09|1.61|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.61|-0.09|0.0811
73804156|NCT01691560|147157860|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09||||0.8322|TWO_SIDED|95.0|-0.75|0.93|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.93|-0.75|0.8322
73804157|NCT01081769|147157861|SUPERIORITY_OR_OTHER|||||||0.0191|||||||Log Rank|||||||0.0191
73804158|NCT01081769|147157875|SUPERIORITY_OR_OTHER|||||||0.0323|||||||Fisher Exact|||||||0.0323
73804159|NCT00507455|147157876|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-6.15|||||TWO_SIDED|95.0|-14.67|2.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||2.37|-14.67|
73804160|NCT00507455|147157876|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-5.0|||||TWO_SIDED|95.0|-13.85|3.84|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||3.84|-13.85|
73895469|NCT01578850|147324491|SUPERIORITY_OR_OTHER||Difference in proportions|18.8|||<|0.001|TWO_SIDED|95.0|10.16|27.38|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||27.38|10.16|<0.001
73804161|NCT00507455|147157878|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|1.67|||||TWO_SIDED|95.0|0.5|2.85|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||2.85|0.50|
73804162|NCT00507455|147157878|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|2.18|||||TWO_SIDED|95.0|0.98|3.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||3.37|0.98|
73804163|NCT01737710|147157894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.082|TWO_SIDED|95.0|0.92|3.55||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact|||||3.55|0.92|0.082
73804164|NCT01737710|147157895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.801|TWO_SIDED|95.0|0.26|2.56||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups|Fisher Exact|||||2.56|0.26|0.801
73804165|NCT01737710|147157896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.177|TWO_SIDED|95.0|0.75|5.71||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||5.71|0.75|0.177
73804166|NCT01737710|147157897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.092|TWO_SIDED|95.0|0.96|1.61||Null hypothesis: the fold differences in geometric mean titers against influenza B are not different between the two groups.|ANCOVA|||||1.61|0.96|0.092
73804167|NCT01737710|147157898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.103|TWO_SIDED|95.0|0.32|1.11||Null hypothesis: the fold differences in geometric mean titers against influenza H1N1 are not different between the two groups.|ANCOVA|||||1.11|0.32|0.103
73804168|NCT01737710|147157899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.895|TWO_SIDED|95.0|0.6|1.8||Null hypothesis: the fold differences in geometric mean titers against influenza H3N2 are not different between the two groups.|ANCOVA|||||1.80|0.60|0.895
73804169|NCT01737710|147157900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03|||>|0.999|TWO_SIDED|95.0|0.54|1.97||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact|||||1.97|0.54|>0.999
73804170|NCT01737710|147157901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.253|TWO_SIDED|95.0|0.09|1.63||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||1.63|0.09|0.253
73804171|NCT01737710|147157902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.218|TWO_SIDED|95.0|0.06|1.58||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||1.58|0.06|0.218
73804172|NCT01737710|147157903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.14|TWO_SIDED|95.0|0.84|2.94||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact|||||2.94|0.84|0.140
73804173|NCT01737710|147157904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.791|TWO_SIDED|95.0|0.24|2.65||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||2.65|0.24|0.791
73804174|NCT01737710|147157905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.833|TWO_SIDED|95.0|0.47|2.92||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||2.92|0.47|0.833
73804175|NCT01737710|147157906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.378|TWO_SIDED|95.0|0.4|1.38||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact|||||1.38|0.40|0.378
73804176|NCT01737710|147157907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.783|TWO_SIDED|95.0|0.21|2.62||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||2.62|0.21|0.783
73804177|NCT01737710|147157908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.143|TWO_SIDED|95.0|0.13|1.39|||Fisher Exact|Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.||||1.39|0.13|0.143
73895470|NCT01578850|147324491|SUPERIORITY_OR_OTHER||Difference in proportions|30.9|||<|0.001|TWO_SIDED|95.0|21.03|40.76|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||40.76|21.03|<0.001
73804178|NCT00812981|147157950|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio of HI antibodies against the A/Indonesia/05/2005 strain between the two groups (1562902A CP Group over 1562902A NP Group), being below (\<) 2.0.|Adjusted GMT ratio|0.84|||||TWO_SIDED|95.0|0.71|0.99|||ANCOVA|||Difference in adjusted GMT ratio for HI antibodies: To demonstrate that the NP 1562902A vaccine was non-inferior to the CP 1562902A vaccine, with respect to HI antibody GMT against the A/Indonesia/05/2005 strain, 42 days following vaccination.||0.99|0.71|
73804179|NCT00708461|147158026|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.1202||0.36|TWO_SIDED|95.0|-0.21|0.46||Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates. 95% confidence intervals and p-values derived from t-statistics with 4 degrees of freedom, reflecting the group-randomized design.|ANCOVA|Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates.||"The null hypothesis was no effect of the environmental intervention. The following power assumptions were made:~* Intraclass correlation (ICC) of 0.016, estimated from an earlier study~* Variance of 118 kg, estimated from an earlier study~* Cohort N=400~* 15% attrition (by turnover) Using the external control and a worksite correlation of 0.2 gives a detectable difference of about 1.5 kg or 3 lb, or an effect size of 0.14. The effect size using internal control is 0.20."||0.46|-0.21|0.36
73804180|NCT03517540|147158041|SUPERIORITY||Odds Ratio (OR)|0.8||||0.688|TWO_SIDED|95.0|0.25|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.25|0.688
73804181|NCT03517540|147158041|SUPERIORITY||Odds Ratio (OR)|1.01||||0.985|TWO_SIDED|95.0|0.51|1.99|||Cochran-Mantel-Haenszel|||||1.99|0.51|0.985
73804182|NCT03517540|147158041|SUPERIORITY||Odds Ratio (OR)|0.92||||0.87|TWO_SIDED|95.0|0.3|2.84|||Cochran-Mantel-Haenszel|||||2.84|0.3|0.870
73804183|NCT03517540|147158041|SUPERIORITY||Odds Ratio (OR)|1.21||||0.71|TWO_SIDED|95.0|0.41|3.61|||Cochran-Mantel-Haenszel|||||3.61|0.41|0.710
73804184|NCT03517540|147158042|SUPERIORITY||Odds Ratio (OR)|0.37||||0.136|TWO_SIDED|95.0|0.08|1.61|||Cochran-Mantel-Haenszel|||||1.61|0.08|0.136
73895471|NCT01578850|147324491|SUPERIORITY_OR_OTHER||Difference in proportions|20.6|||<|0.001|TWO_SIDED|95.0|11.78|29.52|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||29.52|11.78|<0.001
73804185|NCT03517540|147158042|SUPERIORITY||Odds Ratio (OR)|0.83||||0.747|TWO_SIDED|95.0|0.24|2.9|||Cochran-Mantel-Haenszel|||||2.9|0.24|0.747
73804186|NCT03517540|147158042|SUPERIORITY||Odds Ratio (OR)|0.84||||0.784|TWO_SIDED|95.0|0.18|3.63|||Cochran-Mantel-Haenszel|||||3.63|0.18|0.784
73804187|NCT03517540|147158042|SUPERIORITY||Odds Ratio (OR)|1.45||||0.521|TWO_SIDED|95.0|0.4|5.69|||Cochran-Mantel-Haenszel|||||5.69|0.4|0.521
73895472|NCT01578850|147324491|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|17.38|36.93|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||36.93|17.38|<0.001
73804188|NCT01779440|147158045|SUPERIORITY|||||||0.65||||||The P-Value of 0.65 was calculated from the difference between groups for the above outcome variable.|Chi-squared|||||||0.65
73804189|NCT01408303|147158058|SUPERIORITY_OR_OTHER||LS mean difference relative to olive oil|-2.95|||<|0.05|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.||||||<0.05
73804190|NCT01408303|147158058|SUPERIORITY_OR_OTHER||LS mean difference relative to olive oil|-6.0|||<|0.0001|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.||||||<0.0001
73804191|NCT01367886|147158094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53|STANDARD_DEVIATION|4.88||0.19|||||||t-test, 2 sided|||||||0.19
73804192|NCT01367886|147158095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|STANDARD_DEVIATION|0.87||0.0021|||||||t-test, 2 sided|||||||0.0021
73804193|NCT01367886|147158096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|1.02||0.18|||||||t-test, 2 sided|||||||0.18
73804194|NCT01367886|147158097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|STANDARD_DEVIATION|1.34||0.0025|||||||t-test, 2 sided|||||||0.0025
73804195|NCT01938092|147158098|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
73804196|NCT01938092|147158099|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
73804197|NCT01938092|147158100|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
73804198|NCT00985504|147158103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.612|TWO_SIDED|95.0|-1.87|1.1|||Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||1.10|-1.87|0.612
73804199|NCT00985504|147158104|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||This is the p-value for Cognition Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.504
73895473|NCT01578850|147324493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.73|-0.2|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||-0.20|-0.73|<0.001
73804200|NCT00985504|147158104|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||This is the p-value for the Behavior Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.665
73804201|NCT00985504|147158104|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||This is the p-value for Emotional Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.489
73804202|NCT00985504|147158104|SUPERIORITY_OR_OTHER|||||||0.945||95.0||||This is the p-value for Other Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.945
73804203|NCT00985504|147158105|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||This is the p-value for the Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.157
73804204|NCT00985504|147158105|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||This is the p-value for the Energy Level score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.119
73804205|NCT00985504|147158105|SUPERIORITY_OR_OTHER|||||||0.184||95.0||||This is the p-value for the Motivation and Interest score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.184
73804206|NCT00985504|147158105|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||This is the p-value for the Cognitive Functioning score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.226
73804207|NCT00985504|147158105|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||This is the p-value for the Weight Gain score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.059
73804208|NCT00985504|147158105|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||This is the p-value for the Sleep score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.466
73804209|NCT00985504|147158105|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||This is the p-value for the Sexual Functioning score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.822
73804210|NCT00985504|147158105|SUPERIORITY_OR_OTHER|||||||0.599||95.0||||This is the p-value for the Affect score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.599
73804211|NCT00985504|147158106|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||This is the p-value for the PGI-I.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.723
73804212|NCT00985504|147158107|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.410
73804213|NCT00985504|147158108|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||This is the p-value for the Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.880
73804214|NCT00985504|147158108|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||This is the p-value for the Item 8 (Inability to Feel) score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.224
73804215|NCT00985504|147158109|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|95.0||||This is the p-value for the Total Score.|ANCOVA|ANCOVA main effect F test||||||0.910
73804216|NCT00985504|147158109|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||This is the p-value for the Motivation/Interest/Enthusiasm Score.|ANCOVA|ANCOVA main effect F test||||||0.882
73804217|NCT00985504|147158109|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||This is the p-value for the Wakefulness/Alertness Score.|ANCOVA|ANCOVA main effect F test||||||0.657
73804218|NCT00985504|147158109|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||This is the p-value for the Energy Score.|ANCOVA|ANCOVA main effect F test||||||0.457
73804219|NCT00985504|147158109|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||This is the p-value for the Ability to Focus/Sustain Attention Score.|ANCOVA|ANCOVA main effect F test||||||0.737
73804220|NCT00985504|147158109|SUPERIORITY_OR_OTHER|||||||0.404||95.0||||This is the p-value for the Ability to Remember/Recall Information Score.|ANCOVA|ANCOVA main effect F test||||||0.404
73804221|NCT00985504|147158109|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||This is the p-value for the Ability to Find Words Score.|ANCOVA|ANCOVA main effect F test||||||0.808
73804222|NCT00985504|147158109|SUPERIORITY_OR_OTHER|||||||0.431||95.0||||This is the p-value for the Sharpness/Mental Acuity Score.|ANCOVA|ANCOVA main effect F test||||||0.431
73804223|NCT00985504|147158110|SUPERIORITY_OR_OTHER|||||||0.821||95.0||||This is the p-value for the SDS Total Score.|ANCOVA|ANCOVA main effect F test||||||0.821
73804224|NCT00985504|147158110|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||This is the p-value for the Item 1 (Work) Score.|ANCOVA|ANCOVA main effect F test||||||0.491
73804225|NCT00985504|147158110|SUPERIORITY_OR_OTHER|||||||0.451||95.0||||This is the p-value for the Item 2 (Family) Score.|ANCOVA|ANCOVA main effect F test||||||0.451
73804226|NCT00985504|147158110|SUPERIORITY_OR_OTHER|||||||0.443||95.0||||This is the p-value for the Item 3 (Social) Score.|ANCOVA|ANCOVA main effect F test||||||0.443
73804227|NCT00985504|147158110|SUPERIORITY_OR_OTHER|||||||0.719||95.0||||This is the p-value for the Item 4 (Days Lost) Score.|ANCOVA|ANCOVA main effect F test||||||0.719
73804228|NCT00985504|147158110|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||This is the p-value for the Item 5 (Days Underproductive) Score.|ANCOVA|ANCOVA main effect F test||||||0.517
73804229|NCT00985504|147158111|SUPERIORITY_OR_OTHER|||||||0.776||95.0|||||Fisher Exact|||||||0.776
73804230|NCT00985504|147158112|SUPERIORITY_OR_OTHER|||||||0.691||95.0|||||Log Rank|||The log-rank test was conducted using Kaplan-Meier Product-Limit method.||||0.691
73804231|NCT00985504|147158113|SUPERIORITY_OR_OTHER|||||||0.724||95.0|||||Fisher Exact|||||||0.724
73804232|NCT03711786|147158114|SUPERIORITY||Odds Ratio (OR)|1.2||||0.836|TWO_SIDED|95.0|0.22|6.65|||Regression - GEE, logistic|From Wald z-statistic from generalized estimating equations (GEE) model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||6.65|0.22|0.836
73804233|NCT03711786|147158115|SUPERIORITY||Odds Ratio (OR)|0.86||||0.877|TWO_SIDED|95.0|0.12|6.14|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||6.14|0.12|0.877
73804234|NCT03711786|147158116|SUPERIORITY||Odds Ratio (OR)|18.36||||0.001|TWO_SIDED|95.0|3.23|104.23|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||104.23|3.23|0.001
73804235|NCT03711786|147158117|SUPERIORITY||Odds Ratio (OR)|2.15||||0.017|TWO_SIDED|95.0|1.15|4.01|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||4.01|1.15|0.017
73804236|NCT03711786|147158118|SUPERIORITY||Odds Ratio (OR)|0.9||||0.759|TWO_SIDED|95.0|0.45|1.8|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||1.80|0.45|0.759
73804237|NCT04031846|147158124|OTHER|Difference in % and 95 % confidence interval (CI) are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|0.6|||=|0.824|TWO_SIDED|95.0|-5.0|6.3|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in % : Injection site erythema||6.3|-5.0|= 0.824
73804238|NCT04031846|147158124|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|2.8|||=|0.324|TWO_SIDED|95.0|-2.8|8.4|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site induration||8.4|-2.8|= 0.324
73804239|NCT04031846|147158124|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|11.3|||<|0.001|TWO_SIDED|95.0|5.8|16.6|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site pain||16.6|5.8|< 0.001
73804240|NCT04031846|147158124|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|4.1|||=|0.128|TWO_SIDED|95.0|-1.2|9.4|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site swelling||9.4|-1.2|= 0.128
73804241|NCT04031846|147158125|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|0.4|||=|0.885|TWO_SIDED|95.0|-5.0|5.8|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Decreased appetite||5.8|-5.0|= 0.885
73804242|NCT04031846|147158125|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|5.4|||=|0.045|TWO_SIDED|95.0|0.1|10.7|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Irritability||10.7|0.1|= 0.045
73804243|NCT04031846|147158125|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|4.4|||=|0.131|TWO_SIDED|95.0|-1.3|10.0|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Somnolence||10.0|-1.3|= 0.131
73804244|NCT04031846|147158125|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|-0.1|||=|0.898|TWO_SIDED|95.0|-2.4|2.1|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Urticaria||2.1|-2.4|= 0.898
73804245|NCT04031846|147158126|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-1.0|0.5|||||V114 minus Prevenar 13™|Difference in %||0.5|-1.0|
73804246|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.62|||<|0.001|TWO_SIDED|95.0|0.57|0.68||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 1 GMC Ratio: CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.68|0.57|< 0.001
73804247|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.28|||<|0.001|TWO_SIDED|95.0|1.17|1.39||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 3 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.39|1.17|< 0.001
73804248|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.68|0.82||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 4 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.82|0.68|< 0.001
73804249|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.59|0.7||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 5 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.70|0.59|< 0.001
73804250|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.61|0.76||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 6A GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.76|0.61|< 0.001
73804251|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.07||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 6B GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.07|0.85|< 0.001
73804252|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.72|0.85||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 7F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.85|0.72|< 0.001
73804253|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.72|||<|0.001|TWO_SIDED|95.0|0.66|0.78||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 9V GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.78|0.66|< 0.001
73804254|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.67|0.83||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 14 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.67|< 0.001
73804255|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.8|0.95||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 18C GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.95|0.80|< 0.001
73804256|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.91||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 19A GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.91|0.75|< 0.001
73804257|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.8|0.97||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 19F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.97|0.80|< 0.001
73804258|NCT04031846|147158127|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.79|0.97||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 23F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.97|0.79|< 0.001
73804259|NCT04031846|147158127|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC Ratio|71.79|||<|0.001|TWO_SIDED|95.0|65.16|79.1||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 22F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||79.10|65.16|< 0.001
73895474|NCT01578850|147324493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.006|TWO_SIDED|95.0|-0.61|-0.11|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||-0.11|-0.61|0.006
73895475|NCT01578850|147324493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-0.96|-0.39|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||-0.39|-0.96|<0.001
73895476|NCT01578850|147324493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.82|-0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||-0.28|-0.82|<0.001
73804260|NCT04031846|147158127|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC Ratio|46.58|||<|0.001|TWO_SIDED|95.0|42.19|51.42||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 33F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||51.42|42.19|< 0.001
73804261|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-4.7|-1.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 1|95% CI is based on the Miettinen \& Nurminen method.|-1.3|-4.7|< 0.001
73804262|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|8.2|||<|0.001|TWO_SIDED|95.0|4.4|12.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 3|95% CI is based on the Miettinen \& Nurminen method.|12.2|4.4|< 0.001
73804263|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.5|-0.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 4|95% CI is based on the Miettinen \& Nurminen method.|-0.1|-4.5|< 0.001
73804264|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.2|-0.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 5|95% CI is based on the Miettinen \& Nurminen method.|-0.2|-2.2|< 0.001
73804265|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.9|1.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 6A|95% CI is based on the Miettinen \& Nurminen method.|1.1|-1.9|< 0.001
73804266|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-3.5|-0.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 6B|95% CI is based on the Miettinen \& Nurminen method.|-0.1|-3.5|< 0.001
73804267|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.9|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 7F|95% CI is based on the Miettinen \& Nurminen method.|0.9|-0.9|< 0.001
73804268|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-2.4|-0.4||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 9V|95% CI is based on the Miettinen \& Nurminen method.|-0.4|-2.4|< 0.001
73804269|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.0|0.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 14|95% CI is based on the Miettinen \& Nurminen method.|0.5|-1.0|< 0.001
73804270|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.8|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 18C|95% CI is based on the Miettinen \& Nurminen method.|0.9|-1.8|< 0.001
73804271|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.2|-0.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 19A|95% CI is based on the Miettinen \& Nurminen method.|-0.2|-2.2|< 0.001
73895477|NCT01578850|147324493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|||<|0.001|TWO_SIDED|95.0|-1.03|-0.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||-0.46|-1.03|<0.001
73804272|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 19F|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
73804273|NCT04031846|147158128|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-2.7|1.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 23F|95% CI is based on the Miettinen \& Nurminen method.|1.5|-2.7|< 0.001
73895478|NCT01578850|147324493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|||<|0.001|TWO_SIDED|95.0|-0.92|-0.37|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||-0.37|-0.92|<0.001
73804274|NCT04031846|147158128|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage Difference|93.8|||<|0.001|TWO_SIDED|95.0|91.5|95.6||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 22F|95% CI is based on the Miettinen \& Nurminen method.|95.6|91.5|< 0.001
73804275|NCT04031846|147158128|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage Difference|94.9|||<|0.001|TWO_SIDED|95.0|92.7|96.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 33F|95% CI is based on the Miettinen \& Nurminen method.|96.5|92.7|< 0.001
73804276|NCT04031846|147158129|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-1.7|0.4||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Diphtheria toxoid|95% CI is based on the Miettinen \& Nurminen method.|0.4|-1.7|< 0.001
73804277|NCT04031846|147158129|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Tetanus toxoid|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
73804278|NCT04031846|147158129|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.3|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis PT|95% CI is based on the Miettinen \& Nurminen method.|0.9|-1.3|< 0.001
73804279|NCT04031846|147158129|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.0|0.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis FHA|95% CI is based on the Miettinen \& Nurminen method.|0.5|-1.0|< 0.001
73804280|NCT04031846|147158129|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis PRN|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
73804281|NCT04031846|147158129|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.3|2.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Hib PRP|95% CI is based on the Miettinen \& Nurminen method.|2.1|-1.3|< 0.001
73804282|NCT04031846|147158129|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-2.0|0.0||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: HBsAg|95% CI is based on the Miettinen \& Nurminen method.|-0.0|-2.0|< 0.001
73804283|NCT04031846|147158129|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.7||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 1|95% CI is based on the Miettinen \& Nurminen method.|0.7|-0.7|< 0.001
73804284|NCT04031846|147158129|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.7||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 2|95% CI is based on the Miettinen \& Nurminen method.|0.7|-0.7|< 0.001
73895479|NCT01578850|147324493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.98|-0.4|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||-0.40|-0.98|<0.001
73804285|NCT04031846|147158129|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.5|1.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 3|95% CI is based on the Miettinen \& Nurminen method.|1.1|-0.5|< 0.001
73804286|NCT04031846|147158130|NON_INFERIORITY|Non-inferiority of Rotarix™ administered concomitantly with V114 to Rotarix™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMT ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.8|1.16||1-sided p-value|t-distribution||V114/Prevenar 13™|GMT Ratio: CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group||1.16|0.80|< 0.001
73804287|NCT04031846|147158131|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.73|0.88|||||V114 / Prevenar 13™|GMC Ratio Serotype 1: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.88|0.73|
73804288|NCT04031846|147158131|OTHER||GMC Ratio|1.85|||||TWO_SIDED|95.0|1.7|2.02|||||V114 / Prevenar 13™|GMC Ratio Serotype 3: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||2.02|1.70|
73804289|NCT04031846|147158131|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.19|||||V114 / Prevenar 13™|GMC Ratio Serotype 4: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.19|0.98|
73804290|NCT04031846|147158131|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.94|||||V114 / Prevenar 13™|GMC Ratio Serotype 5: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.94|0.74|
73804291|NCT04031846|147158131|OTHER||GMC Ratio|0.45|||||TWO_SIDED|95.0|0.4|0.52|||||V114 / Prevenar 13™|GMC Ratio Serotype 6A: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.52|0.40|
73804292|NCT04031846|147158131|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.0|1.41|||||V114 / Prevenar 13™|GMC Ratio Serotype 6B: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.41|1.00|
73804293|NCT04031846|147158131|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.76|0.91|||||V114 / Prevenar 13™|GMC Ratio Serotype 7F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.91|0.76|
73804294|NCT04031846|147158131|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.77|0.96|||||V114 / Prevenar 13™|GMC Ratio Serotype 9V: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.96|0.77|
73804295|NCT04031846|147158131|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.66|0.86|||||V114 / Prevenar 13™|GMC Ratio Serotype 14: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.86|0.66|
73804296|NCT04031846|147158131|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||V114 / Prevenar 13™|GMC Ratio Serotype 18C: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.95|0.77|
73804297|NCT04031846|147158131|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.7|0.87|||||V114 / Prevenar 13™|GMC Ratio Serotype 19A: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.87|0.70|
73804298|NCT04031846|147158131|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.7|0.85|||||V114 / Prevenar 13™|GMC Ratio Serotype 19F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.85|0.70|
73804299|NCT04031846|147158131|OTHER||GMC Ratio|1.22|||||TWO_SIDED|95.0|1.07|1.4|||||V114 / Prevenar 13™|GMC Ratio Serotype 23F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.40|1.07|
73804300|NCT04031846|147158131|OTHER||GMC Ratio|57.69|||||TWO_SIDED|95.0|51.2|65.0|||||V114 / Prevenar 13™|GMC Ratio Serotype 22F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||65.00|51.20|
73804301|NCT04031846|147158131|OTHER||GMC Ratio|6.24|||||TWO_SIDED|95.0|5.46|7.14|||||V114 / Prevenar 13™|GMC Ratio Serotype 33F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||7.14|5.46|
73804302|NCT04031846|147158132|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-4.4|0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 1|95% CI are based on the Miettinen \& Nurminen method.|0.3|-4.4|
73804303|NCT04031846|147158132|OTHER||Percentage Difference|25.7|||||TWO_SIDED|95.0|21.1|30.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 3|95% CI are based on the Miettinen \& Nurminen method.|30.3|21.1|
73804304|NCT04031846|147158132|OTHER||Percentage Difference|-2.9|||||TWO_SIDED|95.0|-5.7|-0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 4|95% CI are based on the Miettinen \& Nurminen method.|-0.3|-5.7|
73804305|NCT04031846|147158132|OTHER||Percentage Difference|-3.9|||||TWO_SIDED|95.0|-8.1|0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 5|95% CI are based on the Miettinen \& Nurminen method.|0.3|-8.1|
73804306|NCT04031846|147158132|OTHER||Percentage Difference|-19.4|||||TWO_SIDED|95.0|-23.9|-15.0|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 6A|95% CI are based on the Miettinen \& Nurminen method.|-15.0|-23.9|
73804307|NCT04031846|147158132|OTHER||Percentage Difference|4.6|||||TWO_SIDED|95.0|-1.5|10.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 6B|95% CI are based on the Miettinen \& Nurminen method.|10.7|-1.5|
73804308|NCT04031846|147158132|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-2.9|0.5|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 7F|95% CI are based on the Miettinen \& Nurminen method.|0.5|-2.9|
73804309|NCT04031846|147158132|OTHER||Percentage Difference|-6.7|||||TWO_SIDED|95.0|-10.1|-3.5|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 9V|95% CI are based on the Miettinen \& Nurminen method.|-3.5|-10.1|
73804310|NCT04031846|147158132|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.6|1.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 14|95% CI are based on the Miettinen \& Nurminen method.|1.7|-2.6|
73804311|NCT04031846|147158132|OTHER||Percentage Difference|-0.7|||||TWO_SIDED|95.0|-3.9|2.6|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 18C|95% CI are based on the Miettinen \& Nurminen method.|2.6|-3.9|
73804312|NCT04031846|147158132|OTHER||Percentage Difference|-1.2|||||TWO_SIDED|95.0|-3.5|1.0|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 19A|95% CI are based on the Miettinen \& Nurminen method.|1.0|-3.5|
73804313|NCT04031846|147158132|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.0|0.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 19F|95% CI are based on the Miettinen \& Nurminen method.|0.7|-2.0|
73804314|NCT04031846|147158132|OTHER||Percentage Difference|6.6|||||TWO_SIDED|95.0|1.3|11.9|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 23F|95% CI are based on the Miettinen \& Nurminen method.|11.9|1.3|
73804315|NCT04031846|147158132|OTHER||Percentage Difference|90.4|||||TWO_SIDED|95.0|87.4|92.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 22F|95% CI are based on the Miettinen \& Nurminen method.|92.7|87.4|
73804316|NCT04031846|147158132|OTHER||Percentage Difference|45.9|||||TWO_SIDED|95.0|41.3|50.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 33F|95% CI are based on the Miettinen \& Nurminen method.|50.3|41.3|
73804317|NCT04031846|147158135|OTHER|Percentage difference and CI are based on the Miettinen \& Nurminen method.|Percentage Difference|15.8|||||TWO_SIDED|95.0|12.9|19.2|||||V114 minus Prevenar 13™|Percentage Difference: V114 Serotype 22F minus Prevenar 13™ Serotype 3||19.2|12.9|
73804318|NCT04031846|147158135|OTHER|Percentage difference and CI are based on the Miettinen \& Nurminen method.|Percentage Difference|15.3|||||TWO_SIDED|95.0|12.2|18.7|||||V114 minus Prevenar 13™|Percentage Difference: V114 Serotype 33F minus Prevenar 13™ Serotype 3||18.7|12.2|
73804319|NCT06868654|147158136|OTHER||Hazard Ratio (HR)|0.24|||||TWO_SIDED|95.0|0.11|0.56|||||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||0.56|0.11|
73804320|NCT01022307|147158159|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis showed that the effect size was small, with a 50% chance of detecting a p \< 0.05 effect requiring 247 subjects.|||||<|0.04|TWO_SIDED||||||F-test|Greenhouse Geisser correction.||F-test evaluating effects of Group||||< 0.04
73804321|NCT00764660|147158177|SUPERIORITY_OR_OTHER||Difference in LS Means|2.4||||0.41|TWO_SIDED|95.0|-3.4|8.2|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.|||8.2|-3.4|0.41
73804322|NCT00764660|147158178|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-1.9||||0.3|TWO_SIDED|95.0|-5.5|1.7|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.|||1.7|-5.5|0.30
73804323|NCT00764660|147158179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.52|TWO_SIDED|95.0|0.57|1.33|||Chi-squared|Zero Inflated Negative Binomial (ZINB) Distribution with terms for treatment and region||||1.33|0.57|0.52
73804324|NCT00764660|147158180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.81|TWO_SIDED|95.0|0.71|1.31|||Chi-squared|ZINB Distribution with terms for treatment and region||||1.31|0.71|0.81
73804325|NCT00764660|147158181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.26|TWO_SIDED|95.0|0.81|2.12||Model with factors treatment and pooled centers as stratum.|Kaplan-Meier|||||2.12|0.81|0.26
73804326|NCT00764660|147158182|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1||||0.59|TWO_SIDED|95.0|-9.9|5.7|||Repeated Measures Model|Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.||||5.7|-9.9|0.59
73804327|NCT00764660|147158183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.34|TWO_SIDED|95.0|0.65|3.43|||Regression, Logistic|An Odds Ratio (SCH 900435/Placebo) \>1 means SCH 900435 has a higher probability of achieving complete abstinence.||||3.43|0.65|0.34
73804328|NCT00764660|147158186|SUPERIORITY_OR_OTHER||Difference in LS Means|2.88||||0.54|TWO_SIDED|95.0|-6.3|12.06|||Contrained Longitudinal Data Analysis||Constrained Longitudinal Data Analysis (cLDA) Model with terms for treatment, pooled centers, assessment by treatment interaction.|||12.06|-6.30|0.54
73804329|NCT00764660|147158187|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.51|TWO_SIDED|95.0|-12.35|6.15|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.|||6.15|-12.35|0.51
73804330|NCT00764660|147158188|SUPERIORITY_OR_OTHER||Difference in LS Means|-9.17||||0.05|TWO_SIDED|95.0|-18.27|-0.07|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.|||-0.07|-18.27|0.05
73804331|NCT04850989|147158247|SUPERIORITY||Mean Difference (Net)|-5.14|STANDARD_DEVIATION|0.49|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
73804332|NCT04850989|147158248|SUPERIORITY||Mean Difference (Net)|-11.54|STANDARD_DEVIATION|-1.23|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
73804333|NCT04850989|147158249|SUPERIORITY||Mean Difference (Net)|-8.08|STANDARD_DEVIATION|1.91|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
73804334|NCT04850989|147158250|SUPERIORITY||Mean Difference (Net)|-8.08|STANDARD_DEVIATION|1.91|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
73804335|NCT04850989|147158251|SUPERIORITY||Mean Difference (Net)|-3.48|STANDARD_DEVIATION|0.28|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||> 0.05
73804336|NCT00651261|147158288|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.009|TWO_SIDED|95.0|0.63|0.96|||1-sided stratified log-rank|||||0.96|0.63|0.009
73804337|NCT00651261|147158289|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.0024|TWO_SIDED|95.0|0.66|0.93|||1-sided stratified log rank|||||0.93|0.66|0.0024
73804338|NCT00651261|147158291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Fisher Exact|||||||0.15
73804339|NCT00651261|147158292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||1-sided stratified log rank|||||||0.0049
73804340|NCT01609010|147158295|SUPERIORITY_OR_OTHER|||||||0.3023|||||||Log Rank|||||||0.3023
73804341|NCT01609010|147158296|SUPERIORITY_OR_OTHER|||||||0.3362|||||||Chi-squared|||Week 10, Cycle 1||||0.3362
73804342|NCT01609010|147158296|SUPERIORITY_OR_OTHER|||||||0.1157|||||||Chi-squared|||Week 16, Cycle 2||||0.1157
73804343|NCT01609010|147158297|SUPERIORITY_OR_OTHER|||||||0.854|||||||Chi-squared|||Week 10, Cycle 1||||0.8540
73804344|NCT01609010|147158297|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Chi-squared|||Week 16, Cycle 2||||0.0051
73804345|NCT01609010|147158299|SUPERIORITY_OR_OTHER|||||||0.784|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu+PR||||0.7840
73804346|NCT01609010|147158299|SUPERIORITY_OR_OTHER|||||||0.4419|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu||||0.4419
73804347|NCT01609010|147158299|SUPERIORITY_OR_OTHER|||||||0.5942|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR only||||0.5942
73804348|NCT01609010|147158301|SUPERIORITY_OR_OTHER|||||||0.8946|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).||||||0.8946
73804349|NCT01609010|147158303|SUPERIORITY_OR_OTHER|||||||0.4963|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).||||||0.4963
73804350|NCT00687271|147158304|OTHER||Difference in Percentage Change|-10.0|||||TWO_SIDED|95.0|-14.6|-5.5|||Longitudinal Data Analysis (LDA) model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-5.5|-14.6|
73804351|NCT00687271|147158304|OTHER||Difference in Percentage Change|-17.9|||||TWO_SIDED|95.0|-23.4|-12.5|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-12.5|-23.4|
73804352|NCT00687271|147158307|OTHER||Difference in Percentage Change|-8.6|||||TWO_SIDED|95.0|-12.7|-4.4|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-4.4|-12.7|
73804353|NCT00687271|147158307|OTHER||Diffence in Percentage Change|-13.9|||||TWO_SIDED|95.0|-18.9|-8.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-8.9|-18.9|
73804354|NCT00687271|147158308|OTHER||Difference in Percentage Change|-7.7|||||TWO_SIDED|95.0|-11.5|-3.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-3.9|-11.5|
73804355|NCT00687271|147158308|OTHER||Difference in Percentage Change|-12.2|||||TWO_SIDED|95.0|-16.8|-7.6|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-7.6|-16.8|
73804356|NCT00687271|147158309|OTHER||Difference in Percentage Change|-7.4|||||TWO_SIDED|95.0|-10.8|-4.1|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-4.1|-10.8|
73804357|NCT00687271|147158309|OTHER||Difference in Percentage Change|-11.0|||||TWO_SIDED|95.0|-15.1|-7.0|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-7.0|-15.1|
73804358|NCT00687271|147158310|OTHER||Dfferecne in Percentage Change|-2.4|||||TWO_SIDED|95.0|-6.6|1.8|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||1.8|-6.6|
73804359|NCT00687271|147158310|OTHER||Difference in Percentage Change|-0.7|||||TWO_SIDED|95.0|-5.8|4.4|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||4.4|-5.8|
73804360|NCT00687271|147158311|OTHER||Difference in Percentage Change|-1.0|||||TWO_SIDED|95.0|-7.7|5.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||5.9|-7.7|
73804361|NCT00687271|147158311|OTHER||Difference in Percentage Change|5.5|||||TWO_SIDED|95.0|-4.6|16.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||16.9|-4.6|
73804362|NCT01134107|147158312|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.36|||||TWO_SIDED|95.0|0.06|0.66|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline HbA1c|This was the primary gated analysis.||0.66|0.06|
73804363|NCT01134107|147158313|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.18|||||TWO_SIDED|95.0|-0.1|0.47|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 1-6) minus Insulin Aspart 6 Day (Day 1-6); adjusted for Treatment + Sequence + Period + Baseline HbA1c|||0.47|-0.10|
73804364|NCT01134107|147158313|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.42|||||TWO_SIDED|95.0|0.25|0.58|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 6) minus Insulin Lispro 6 Day (Day 2); adjusted for DayGroup + Period + Baseline HbA1c|||0.58|0.25|
73804365|NCT01134107|147158314|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.38|||||TWO_SIDED|95.0|-0.13|0.88|||||Daily Total Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.88|-0.13|
73804366|NCT01134107|147158314|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|||||TWO_SIDED|95.0|-0.26|0.31|||||Daily Basal Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.31|-0.26|
73804367|NCT01134107|147158314|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|||||TWO_SIDED|95.0|-0.15|0.6|||||Daily Bolus Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.60|-0.15|
73804368|NCT01134107|147158315|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|||||TWO_SIDED|95.0|0.08|0.24|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c|||0.24|0.08|
73804369|NCT01134107|147158316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.39|1.63|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.63|0.39|
73804370|NCT01134107|147158316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36|||||TWO_SIDED|95.0|0.2|0.63|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||0.63|0.20|
73804371|NCT01134107|147158317|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for Total Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Total Dose.|Crossover Model|||||||0.595
73804372|NCT01134107|147158317|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||P-value for Basal Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Basal Dose.|Crossover Model|||||||0.506
73804373|NCT01134107|147158317|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value for Bolus Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Bolus Dose.|Crossover Model|||||||0.790
73804374|NCT01134107|147158319|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||negative binomial test|P-value computed using a negative binomial test including factors for treatment, period and sequence.||||||0.059
73804375|NCT01134107|147158320|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for overall pump complications associated with a premature reservoir change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test|||||||1.00
73804376|NCT01134107|147158320|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value for overall pump complications associated with a premature infusion set change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test|||||||0.472
73804377|NCT01134107|147158321|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||P-value for Premature Reservoir Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test|||||||0.383
73804378|NCT01134107|147158321|SUPERIORITY_OR_OTHER|||||||0.499||95.0||||P-value for Premature Infusion Set Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test|||||||0.499
73804379|NCT01134107|147158322|SUPERIORITY_OR_OTHER|||||||1||95.0||||The p-value is for the Documented Hypoglycemic Episodes category treatment arm comparison. The p-value for the All Reported Hypoglycemic Episodes category could not be generated using Gart's Test.|Gart's Test|Participants represented in both treatment groups, and with non-missing incidence value in each treatment period, were used for p-value calculation.||||||1.00
73804380|NCT01134107|147158323|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Negative Binomial Test|P-value computed using a negative binomial test including factors for treatment, period and sequence.||||||<0.001
73804381|NCT01134107|147158324|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Crossover Model|P-value computed using crossover model. Response = treatment + sequence + period + baseline body weight||||||<0.001
73804382|NCT01134107|147158325|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||P-value for the Systolic Blood Pressure (SBP) computed using crossover model. Response = treatment + sequence + period + baseline systolic blood pressure.|Crossover Model|||||||0.147
73804383|NCT01134107|147158325|SUPERIORITY_OR_OTHER|||||||0.894||95.0||||P-value for Diastolic Blood Pressure (DBP) computed using crossover model. Response = treatment + sequence + period + baseline diastolic blood pressure.|Crossover Model|||||||0.894
73804384|NCT02314260|147158326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.917|STANDARD_ERROR_OF_MEAN|0.0318||0|TWO_SIDED|95.0|0.854|0.979||Under the nonparametric assumption. P-value \<0.05, means statistical significance|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-Specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)||0.979|0.854|0.000
73804385|NCT02314260|147158327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.806|STANDARD_ERROR_OF_MEAN|0.0578||0|TWO_SIDED|95.0|0.693|0.919||Under the nonparametric assumption P value \<0.05 is statistically significant|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)||0.919|0.693|0.000
73804386|NCT02314260|147158328|SUPERIORITY_OR_OTHER||Slope|4.5|STANDARD_ERROR_OF_MEAN|0.0318||0|TWO_SIDED|95.0|0.0|10.0||P\<0.05 is significant|t-test, 2 sided||at a cutoff value of 4.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.87(87%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.||10|0.00|0.000
73804387|NCT02314260|147158329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|0.0578||0|TWO_SIDED|95.0|0.0|10.0||P\<0.05 is significant|t-test, 2 sided||at a cutoff value of 5.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.73 (73%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.||10|0.00|0.000
73804388|NCT02362672|147158336|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0019|TWO_SIDED||||||z-test|||NKTR-181 (Double-blind Treatment Phase), Placebo (Double-blind Treatment Phase)||||0.0019
73804389|NCT05483686|147158342|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||This analysis aims to detect a significant change (p = .05) in percentage of participants with HIV transmission risk between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.19
73804390|NCT05483686|147158343|SUPERIORITY||||||=|0.24|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in ART adherence between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||=.24
73804391|NCT05483686|147158344|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in condom use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.79
73804392|NCT05483686|147158345|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to ART use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.81
73804393|NCT05483686|147158346|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to PrEP use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.14
73895480|NCT01578850|147324493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.91|-0.36|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||-0.36|-0.91|<0.001
73895481|NCT01578850|147324494|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
73804394|NCT05483686|147158347|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to condom use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.81
73804395|NCT05483686|147158348|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in social support between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.30
73804396|NCT05483686|147158349|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in gender identity comfort between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.94
73804397|NCT01543178|147158350|SUPERIORITY_OR_OTHER|||||||0.0232|TWO_SIDED|||||The a priori threshold for statistical significance was p \< 0.05.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel method was adjusted for analysis center and time to recurrence during Maintenance Phase 1.||A worst case analysis was performed, in which patients with \< 4 days of IBS symptom data in a given week were considered as non-responders for that week.||||0.0232
73804398|NCT03351608|147158357|SUPERIORITY||GM Ratio (SUG 2 mg / NEO + [GLY or ATR])|0.22|||<|0.0001|TWO_SIDED|95.0|0.16|0.32|||ANOVA|||||0.32|0.16|< 0.0001
73804399|NCT02727478|147158360|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||< 0.001
73804400|NCT02727478|147158361|SUPERIORITY||||||=|0.001|||||||ANOVA|||||||=0.001
73804401|NCT02727478|147158362|OTHER|||||||0.254|||||||Wilcoxon (Mann-Whitney)|||||||0.254
73804402|NCT02727478|147158363|SUPERIORITY||||||=|0.065|||||||Wilcoxon (Mann-Whitney)|||||||=0.065
73804403|NCT02727478|147158364|SUPERIORITY||||||=|0.301|||||||ANOVA|||||||=0.301
73804404|NCT02727478|147158365|SUPERIORITY||||||=|0.792|||||||ANOVA|||||||=0.792
73804405|NCT02727478|147158366|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
73804406|NCT03150719|147158407|SUPERIORITY||Mean Difference|2.7|||||TWO_SIDED|95.0|1.0|4.4||||||||4.4|1.0|
73804407|NCT03150719|147158408|SUPERIORITY||Mean Difference|6.7|||||TWO_SIDED|95.0|2.5|10.9||||||||10.9|2.5|
73804408|NCT03150719|147158409|SUPERIORITY||Mean Difference|1.1|||||TWO_SIDED|95.0|-4.9|7.0||||||||7.0|-4.9|
73804409|NCT02019264|147158440|NON_INFERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. MACE met non-inferiority when the one-sided upper bound of 97.5% confidence interval of the HR was less than 1.4 (the non-inferiority margin).|Hazard Ratio (HR)|1.005||||0.0001|TWO_SIDED|97.5|0.842|1.198|||Primary Analytic Method|||||1.198|0.842|0.0001
73804410|NCT02019264|147158441|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.969||||0.5464|TWO_SIDED|95.0|0.873|1.074|||Primary Analytic Method|||||1.074|0.873|0.5464
73804411|NCT02019264|147158442|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment as covariate.|Hazard Ratio (HR)|0.807||||0.038|TWO_SIDED|95.0|0.659|0.988|||Primary Analytic Method|||||0.988|0.659|0.0380
73804412|NCT02019264|147158443|NON_INFERIORITY|Myocardial Infarction: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|0.991||||0.0001|TWO_SIDED|97.5|0.824|1.191|||Primary Analytic Method|||||1.191|0.824|0.0001
73804413|NCT02019264|147158443|NON_INFERIORITY|Time to Stroke: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% CI refers to the upper limit of the displayed 2-sided 95% CI.|Hazard Ratio (HR)|0.856||||0.0005|TWO_SIDED|97.5|0.639|1.145|||Primary Analytic Method|||||1.145|0.639|0.0005
73804414|NCT02019264|147158443|NON_INFERIORITY|Cardiovascular Death: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|1.045||||0.0262|TWO_SIDED|97.5|0.778|1.404|||Primary Analytic Method|||||1.404|0.778|0.0262
73804415|NCT02019264|147158443|SUPERIORITY|Hospitalization for Unstable Angina: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.163||||0.3243|TWO_SIDED|95.0|0.861|1.571|||Primary Analytic Method|||||1.571|0.861|0.3243
73804416|NCT02019264|147158443|SUPERIORITY|Heart Failure: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.952||||0.6758|TWO_SIDED|95.0|0.757|1.197|||Primary Analytic Method|||||1.197|0.757|0.6758
73804417|NCT02019264|147158443|SUPERIORITY|Coronary Revascularization: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.981||||0.7817|TWO_SIDED|95.0|0.856|1.125|||Primary Analytic Method|||||1.125|0.856|0.7817
73804418|NCT02019264|147158444|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.082||||0.4212|TWO_SIDED|95.0|0.893|1.31|||Primary Analytic Method|||||1.310|0.893|0.4212
73804419|NCT02019264|147158445|SUPERIORITY|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|1.124||||0.181|TWO_SIDED|95.0|0.947|1.333|||Primary Analytic Method|||||1.333|0.947|0.1810
73804420|NCT02019264|147158446|SUPERIORITY|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.773||||0.0116|TWO_SIDED|95.0|0.633|0.944|||Primary Analytic Method|||||0.944|0.633|0.0116
73804421|NCT02019264|147158447|SUPERIORITY||Least square (LS) Mean Difference (Net)|-0.39|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.35||P-value was based on analysis of covariance (ANCOVA) model with treatment and stratification variable (presence of established CV disease or CV risk factors without established CV disease) as factors, and baseline HbA1c, as a covariate.|ANCOVA|||||-0.35|-0.43|<0.0001
73804422|NCT02019264|147158448|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.869||||0.0054|TWO_SIDED|95.0|0.787|0.959|||Primary Analytic Method|||||0.959|0.787|0.0054
73804423|NCT02019264|147158449|SUPERIORITY|Hazard ratio on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.904||||0.3661|TWO_SIDED|95.0|0.727|1.125|||Primary Analytic Method|||||1.125|0.727|0.3661
73804424|NCT02019264|147158450|SUPERIORITY||Hazard Ratio (HR)|0.855||||0.0082|TWO_SIDED|95.0|0.762|0.96|||Primary Analytic Method|||||0.960|0.762|0.0082
73804425|NCT02019264|147158451|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.182||||0.0297|TWO_SIDED|95.0|1.017|1.375|||Primary Analytic Method|||||1.375|1.017|0.0297
73804426|NCT02019264|147158452|SUPERIORITY||Odds Ratio (OR)|1.21||||0.5015|TWO_SIDED|95.0|0.69|2.11||P-value was based on logistic regression including treatment as a factor and baseline body mass index (BMI) as a covariate.|Regression, Logistic|||||2.11|0.69|0.5015
73804427|NCT02019264|147158453|SUPERIORITY||Odds Ratio (OR)|1.31||||0.7249|TWO_SIDED|95.0|0.29|5.98||P-value was based on logistic regression including treatment as a factor and baseline BMI as a covariate.|Regression, Logistic|||||5.98|0.29|0.7249
73804428|NCT02019264|147158454|SUPERIORITY||Least square (LS) Mean Difference (Net)|-0.9036||||0.2976|TWO_SIDED|95.0|-1.2908|-0.5163||P value was based on a mixed-effects model (unstructured covariance matrix) with repeated measures with treatment, month and treatment by month interaction as factors and baseline pulmonary arterial systolic pressure and baseline BMI as covariates.|Mixed-effects model|||||-0.5163|-1.2908|0.2976
73804429|NCT00942890|147158478|SUPERIORITY_OR_OTHER||Slope|0.9|STANDARD_ERROR_OF_MEAN|0.24|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
73804430|NCT00942890|147158484|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Linear|||||||<0.05
73804431|NCT04922255|147158491|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
73804432|NCT04922255|147158492|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||||||0.50
73804433|NCT04922255|147158493|SUPERIORITY|||||||0.3|||||||ANOVA|||||||0.30
73804434|NCT04922255|147158494|SUPERIORITY|||||||0.7|||||||Chi-squared|||||||0.70
73804435|NCT04922255|147158495|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
73804436|NCT02677922|147158498|SUPERIORITY||Odds Ratio (OR)|4.86||||0.0003|TWO_SIDED|95.0|1.99|11.85|||Chi-squared|||||11.85|1.99|0.0003
73804437|NCT02677922|147158501|SUPERIORITY||Cox Proportional Hazard|0.59||||0.1083|TWO_SIDED|95.0|0.3|1.13|||Log Rank|||||1.13|0.30|0.1083
73895482|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|1.4||||0.961|TWO_SIDED|95.0|-6.13|8.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 24||8.90|-6.13|0.961
73895483|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|21.5||||0.001|TWO_SIDED|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 28||32.02|10.99|0.001
73804438|NCT02677922|147158503|SUPERIORITY||Odds Ratio (OR)|8.65|||<|0.001|TWO_SIDED|95.0|2.74|27.31|||Chi-squared|||||27.31|2.74|<0.001
73804439|NCT02677922|147158504|SUPERIORITY||Odds Ratio (OR)|1.77||||0.1943|TWO_SIDED|95.0|0.74|4.2|||Chi-squared|||||4.20|0.74|0.1943
73804440|NCT02677922|147158507|SUPERIORITY||Cox Proportional Hazard|0.99||||0.972|TWO_SIDED|95.0|0.52|1.87|||Log Rank|Unstratified log-rank test|Cox proportional hazards regression model|||1.87|0.52|0.9720
73804441|NCT02677922|147158508|OTHER|Confidence interval of difference|Difference|2.6|||||TWO_SIDED|95.0|-17.3|22.5|||||The CI for the difference was derived using Greenwood's variance estimate.|||22.5|-17.3|
73804442|NCT04205643|147158533|SUPERIORITY||Difference estimated using CMH weights|21.1|||<|0.0001|TWO_SIDED|95.0|11.8|29.3||If the primary endpoint is significant, a fixed sequence procedure was employed to control the overall type I error rate of the key secondary endpoints.|Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.|The 95% stratified Newcombe CI with CMH weights|||29.3|11.8|<0.0001
73804443|NCT03515811|147158538|OTHER||Percentage and confidence interval|10.6|||||TWO_SIDED|95.0|5.0|19.2|||||95% CI: 5.0%-19.2%|||19.2|5.0|
73804444|NCT03515811|147158538|OTHER||Percentage and confidence interval|0.0|||||TWO_SIDED|95.0|0.0|7.0|||||95% CI: 0.0%-7.0%|||7.0|0.0|
73804445|NCT03515811|147158539|OTHER||Percentage and confidence interval|6.6|||||TWO_SIDED|95.0|3.1|12.2|||||95% CI: 3.1%-12.2%|||12.2|3.1|
73804446|NCT02589639|147158575|SUPERIORITY|The superiority of empagliflozin 10 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.11|-0.73|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment||"The statistical model was:~Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error"|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)|-0.73|-1.11|<0.0001
73804447|NCT02589639|147158575|SUPERIORITY|The superiority of empagliflozin 25 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.18|-0.82|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)|The statistical model was: Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error||-0.82|-1.18|<0.0001
73804448|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||A priori threshold p \< 0.05|Repeated Measures ANOVA|||||||<0.00005
73804449|NCT02811965|147158610|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
73804450|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804451|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804452|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804453|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804454|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804455|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804456|NCT02811965|147158610|SUPERIORITY|||||||0.01||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.01
73804457|NCT02811965|147158610|SUPERIORITY|||||||0.0002||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0002
73804458|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804459|NCT02811965|147158610|SUPERIORITY||||||<|5e-05|||||||t-test, 2 sided|||||||<0.00005
73804460|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804461|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804462|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804463|NCT02811965|147158610|SUPERIORITY|||||||0.24||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.24
73804464|NCT02811965|147158610|SUPERIORITY|||||||0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.14
73804465|NCT02811965|147158610|SUPERIORITY|||||||0.0093||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0093
73804466|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804467|NCT02811965|147158610|SUPERIORITY|||||||0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.14
73804468|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804469|NCT02811965|147158610|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804470|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||A priori threshold p\<0.05.|Repeated Measures ANOVA|||||||<0.00005
73804471|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804472|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804473|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804474|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804475|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804476|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804477|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804478|NCT02811965|147158611|SUPERIORITY|||||||0.0011||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0011
73804479|NCT02811965|147158611|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
73804480|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804481|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804482|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804483|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804484|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804485|NCT02811965|147158611|SUPERIORITY|||||||0.53||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.53
73804486|NCT02811965|147158611|SUPERIORITY|||||||0.092||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.092
73804487|NCT02811965|147158611|SUPERIORITY|||||||0.0044|||||||t-test, 2 sided|||||||0.0044
73804488|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804489|NCT02811965|147158611|SUPERIORITY|||||||0.084||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.084
73804490|NCT02811965|147158611|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
73804491|NCT02811965|147158611|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
73804492|NCT00915018|147158678|SUPERIORITY||Hazard Ratio (HR)|1.015||||0.8934|TWO_SIDED|95.0|0.813|1.269|||Log Rank|||||1.269|0.813|0.8934
73804493|NCT00915018|147158679|OTHER||Risk Difference (RD)|0.028||||0.5219|TWO_SIDED|95.0|-0.048|0.105|||Mantel Haenszel|||||0.105|-0.048|0.5219
73804494|NCT00915018|147158680|OTHER||Hazard Ratio (HR)|0.974||||0.8431|TWO_SIDED|95.0|0.752|1.262|||Log Rank|||||1.262|0.752|0.8431
73804495|NCT00915018|147158681|OTHER||Risk Difference (RD)|-0.032||||0.236|TWO_SIDED|95.0|-0.093|0.029|||Mantel Haenszel|||||0.029|-0.093|0.2360
73804496|NCT00915018|147158682|OTHER||Hazard Ratio (HR)|0.449||||0.0036|TWO_SIDED|95.0|0.259|0.78|||Log Rank|||||0.780|0.259|0.0036
73804497|NCT00300885|147158724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.915||95.0|0.94|1.41||According to protocol specified O'Brien-Fleming type alpha spending function and 384 deaths at interim analysis (IA), one-sided alpha value for IA was 0.0046.|Log Rank||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with overall alpha of 0.025 stratified by same stratification factors as randomization|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 30% improvement in median OS (i.e. HR of 0.76923, Sorafenib+C/P over Placebo+C/P -Null: theta\>=1, Alternative: theta\<=0.76923). With overall one-sided alpha of 0.025, 90% power and randomization of 1:1, one formal interim analysis and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of 614 events (deaths) were required.||1.41|0.94|0.915
73804498|NCT00300885|147158725|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.433||95.0|0.84|1.16|||Log Rank|||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with alpha of 0.025 stratified by same stratification factors at randomization||1.16|0.84|0.433
73804499|NCT00300885|147158726|SUPERIORITY_OR_OTHER||difference in response rate (CR+PR rate)|-3.65||||0.1015||95.0|-9.18|1.89||no adjustments|Cochran-Mantel-Haenszel||difference in response rates (Complete Response (CR) + Partial Response (PR)) = Placebo+C/P - Sorafenib+C/P|Objective response rate (ie. CR+PR rate) was compared between treatment arms using Cochran-Mantel-Haenszel test with one-side alpha 0.025 adjusting for same stratification factors as randomization||1.89|-9.18|0.1015
73804500|NCT00603902|147158730|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio, log|2.69|||<|0.0001|TWO_SIDED|95.0|2.31|3.13|||Regression, Logistic|Adjustments for baseline body weight.||||3.13|2.31|<0.0001
73804501|NCT00603902|147158731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.44|-2.56|||ANCOVA|||||-2.56|-3.44|<0.0001
73804502|NCT02801617|147158769|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 2 mmHg analysis by protocol||||||0.861|||||||t-test, 2 sided|||||||0.861
73804503|NCT02801617|147158769|NON_INFERIORITY|it will be considered not inferior if they keep the TIOP with differences of no more than 2 mmHg||||||0.89|||||||t-test, 2 sided|||||||0.890
73804504|NCT02801617|147158770|NON_INFERIORITY|intention-to-treat analysis (ITT)||||||0.329|||||||Chi-squared|||||||0.329
73804505|NCT02801617|147158771|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.388|||||||Chi-squared, Corrected|||||||0.388
73804506|NCT02801617|147158772|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.125|||||||Chi-squared, Corrected|||||||0.125
73804507|NCT02801617|147158773|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.434|||||||Chi-squared, Corrected|||||||0.434
73804508|NCT02801617|147158774|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0|||||||Chi-squared, Corrected|||||||0
73804509|NCT02801617|147158775|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.039|||||||Chi-squared|||||||0.039
73804510|NCT06110494|147158795|OTHER|Pairwise comparisons were done using Mann-Whitney U test of log10 transformed CFU reduction data to compare the antimicrobial effectiveness.||||||0.05||||||Pairwise comparisons were done using Mann-Whitney U test of log 10 transformed data to compare the antimicrobial effectiveness of Fer/H2O2 in comparison with the negative (saline) and positive (NaOCl) controls with P values set at \< 0.05|Wilcoxon (Mann-Whitney)|||The sample size estimate was calculated in Pass Software 2021, using a test that compares the ratio of two means from independent samples using data that has been log-normalized. An alpha of 0.05 and power of 80% was assumed, with means and standard deviations pulled from previous studies that employed similar methodology. This produced a required sample size of 16 for each group. Pairwise comparisons were done using Mann-Whitney U test to compare the antimicrobial effectiveness.||||0.05
73804511|NCT03612596|147158872|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
73804512|NCT03612596|147158873|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
73804513|NCT03612596|147158874|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
73804514|NCT03612596|147158875|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
73804515|NCT03612596|147158876|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
73804516|NCT03612596|147158877|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 1.26) rather than test efficacy.||||||0.53
73804517|NCT03612596|147158878|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 1.16) rather than test efficacy.||||||0.44
73804518|NCT03612596|147158879|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 0.67) rather than test efficacy.||||||0.93
73804519|NCT03612596|147158880|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
73804520|NCT03612596|147158881|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||0.16
73804521|NCT03612596|147158882|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
73804522|NCT03612596|147158883|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
73804523|NCT03612596|147158884|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
73804524|NCT04994691|147158898|SUPERIORITY||Risk Ratio (RR)|1.92||||0|TWO_SIDED|95.0|1.38|2.6|||Regression, Logistic||Standard Message vs. No Message|||2.60|1.38|0.000
73804525|NCT04994691|147158898|SUPERIORITY||Risk Ratio (RR)|1.52||||0.023|TWO_SIDED|95.0|1.06|2.13|||Regression, Logistic||Tailored Message vs. No Message|||2.13|1.06|0.023
73804526|NCT04994691|147158898|SUPERIORITY||Risk Ratio (RR)|1.26||||0.124|TWO_SIDED|95.0|0.94|1.66|||Regression, Logistic||Standard Message vs. Tailored Message|||1.66|0.94|0.124
73804527|NCT04994691|147158899|SUPERIORITY||Risk Ratio (RR)|1.97||||0.001|TWO_SIDED|95.0|1.32|2.84|||Regression, Logistic||Standard Message vs. No Message|||2.84|1.32|0.001
73804528|NCT04994691|147158899|SUPERIORITY||Risk Ratio (RR)|1.57||||0.04|TWO_SIDED|95.0|1.02|2.34|||Regression, Logistic||Tailored Message vs. No Message|||2.34|1.02|0.040
73804529|NCT04994691|147158899|SUPERIORITY||Risk Ratio (RR)|1.26||||0.202|TWO_SIDED|95.0|0.88|1.74|||Regression, Logistic||Standard Message vs. Tailored Message|||1.74|0.88|0.202
73804530|NCT02573181|147158904|OTHER|Difference in percentage with AEs|Difference|4.2|||||TWO_SIDED|95.0|-7.4|15.8|||||Difference and 95% CI calculated based on Miettinen \& Nurminen method.|||15.8|-7.4|
73804531|NCT02573181|147158906|OTHER|Difference in % with fatigue|Fatigue difference|-0.9|||||TWO_SIDED|95.0|-10.7|8.8|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||8.8|-10.7|
73804532|NCT02573181|147158906|OTHER|Difference in % with arthralgia|Arthralgia difference|-3.2|||||TWO_SIDED|95.0|-10.2|3.4|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||3.4|-10.2|
73804533|NCT02573181|147158906|OTHER|Difference in % with myalgia|Myalgia difference|4.6|||||TWO_SIDED|95.0|-3.9|13.3|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||13.3|-3.9|
73804534|NCT02573181|147158906|OTHER|Difference in % with headache|Headache difference|-2.5|||||TWO_SIDED|95.0|-11.4|6.4|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||6.4|-11.4|
73804535|NCT01814696|147158984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.605||||||a prior threshold p\<0.05|Fisher Exact|||||||0.605
73804536|NCT01814696|147158985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.604|TWO_SIDED||||||Fisher Exact|||Heart failure related ED visits||||0.604
73804537|NCT01814696|147158985|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||Non-heart failure related ED visits||||1.000
73804538|NCT01814696|147158985|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677|TWO_SIDED||||||Fisher Exact|||All cause ED visits||||0.677
73804539|NCT01814696|147158986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.341|TWO_SIDED||||||Fisher Exact|||||||0.341
73804540|NCT01814696|147158986|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042|TWO_SIDED||||||Fisher Exact|||||||0.042
73804541|NCT01814696|147158987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.497|TWO_SIDED||||||Wilcoxon rank-sum test|||All cause||||0.497
73804542|NCT01814696|147158987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|TWO_SIDED||||||Wilcoxon rank-sum test|||Heart failure related||||0.413
73804543|NCT01814696|147158987|SUPERIORITY_OR_OTHER_LEGACY|||||||0.944|TWO_SIDED||||||Wilcoxon rank-sum test|||Non-heart failure ED visits||||0.944
73804544|NCT01814696|147158988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|TWO_SIDED||||||Wilcoxon rank-sum test|||All cause||||0.057
73804545|NCT01814696|147158988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|TWO_SIDED||||||Wilcoxon rank-sum test|||Heart failure related||||0.236
73804546|NCT01814696|147158988|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|TWO_SIDED||||||Wilcoxon rank-sum test|||Non heart failure related||||0.236
73804547|NCT01814696|147158989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Wilcoxon rank-sum test|||All cause||||0.034
73804548|NCT01814696|147158989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196|||||||Wilcoxon rank-sum test|||Heart failure related||||0.196
73804549|NCT01814696|147158989|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|TWO_SIDED||||||Wilcoxon rank-sum test|||Non heart failure related||||0.210
73804550|NCT01814696|147158990|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
73804551|NCT01422889|147159055|SUPERIORITY_OR_OTHER||percentage|2.2|||||TWO_SIDED|||||A p-value was not calculated for the ION Registry 12 month cardiac events. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.||||2.2% (23/1028) of ION Registry subjects experienced CD/MI related to the ION stent at 12 months||||
73804552|NCT01422889|147159056|SUPERIORITY_OR_OTHER||percentage|2.6|||||ONE_SIDED|||||A p-value was not calculated for the ION Registry 2 year cardiac events. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.||||2.6% (27/1054) of ION Registry subjects experienced ARC ST Definite/Probable related to the ION stent at 2 years.||||
73804553|NCT02977572|147159059|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Based upon previous results, the investigators considered that the need for an intubation could be reduced by 15% \[19% in the CPAP group (control) vs. 4% in the NIV group (study)\]. The estimated sample size was 55 participants in each group (confidence interval \[1-α\] = 90% and power \[1-β\] = 85%).||||1.000
73804554|NCT01197534|147159082|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.08|<0.001
73804555|NCT01197534|147159083|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.08|||<|0.001|TWO_SIDED|95.0|0.04|0.12|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|0.04|<0.001
73804556|NCT01197534|147159084|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.13|||<|0.001|TWO_SIDED|95.0|0.07|0.18|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.07|<0.001
73804557|NCT01197534|147159084|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.1|||<|0.001|TWO_SIDED|95.0|0.05|0.15|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.15|0.05|<0.001
73804558|NCT01197534|147159085|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.07|||<|0.001|TWO_SIDED|95.0|0.03|0.1|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.10|0.03|<0.001
73804559|NCT01197534|147159085|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.03||||0.033|TWO_SIDED|95.0|0.0|0.07|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|0.00|0.033
73804560|NCT01197534|147159086|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
73804561|NCT01197534|147159086|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
73804562|NCT01197534|147159087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|3.42|14.8|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.80|3.42|<0.001
73804563|NCT01197534|147159087|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|1.88|8.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.65|1.88|<0.001
73804564|NCT01197534|147159088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.3|||<|0.001|TWO_SIDED|95.0|3.23|16.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||16.65|3.23|<0.001
73804565|NCT01197534|147159088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.81|14.71|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.71|2.81|<0.001
73804566|NCT01197534|147159089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84|||<|0.001|TWO_SIDED|95.0|2.06|3.91||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio \> 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.91|2.06|<0.001
73804567|NCT01197534|147159089|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.77|3.37||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio \> 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.37|1.77|<0.001
73804568|NCT01197534|147159090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.73|3.46|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.46|1.73|<0.001
73804569|NCT01197534|147159090|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.46|2.94|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.94|1.46|<0.001
73804570|NCT01197534|147159091|SUPERIORITY_OR_OTHER|||||||0.904||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.||||0.904
73804571|NCT01197534|147159091|SUPERIORITY_OR_OTHER|||||||0.342||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.||||0.342
73804572|NCT01197534|147159092|SUPERIORITY_OR_OTHER||Treatment difference|2.47|||<|0.001|TWO_SIDED|95.0|1.47|3.48||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.48|1.47|<0.001
73804573|NCT01197534|147159092|SUPERIORITY_OR_OTHER||Treatment difference|1.64||||0.001|TWO_SIDED|95.0|0.63|2.65||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.65|0.63|0.001
73804574|NCT01197534|147159093|SUPERIORITY_OR_OTHER||Treatment difference|2.09|||<|0.001|TWO_SIDED|95.0|0.97|3.2||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.20|0.97|<0.001
73804575|NCT01197534|147159093|SUPERIORITY_OR_OTHER||Treatment difference|1.96|||<|0.001|TWO_SIDED|95.0|0.83|3.08||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.08|0.83|<0.001
73804576|NCT01014169|147159144|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.95|1.34||||||||1.34|0.95|
73804577|NCT01014169|147159145|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.99|1.25||||||||1.25|0.99|
73804578|NCT01014169|147159146|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||||95.0|1.0|1.25||||||||1.25|1.00|
73895484|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|18.3||||0.007|TWO_SIDED|95.0|8.08|28.53|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 28||28.53|8.08|0.007
73804579|NCT02593097|147159147|SUPERIORITY|||||||0.83|||||||Hills-Armitage|||||||0.83
73804580|NCT02593097|147159148|SUPERIORITY|||||||0.16|||||||McNemar|||||||0.16
73804581|NCT03627546|147159187|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
73804582|NCT03627546|147159188|SUPERIORITY|||||||0.0007|||||||Chi-squared|||||||0.0007
73895485|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|31.4|||<|0.001|TWO_SIDED|95.0|21.42|41.39|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 36||41.39|21.42|<0.001
73895486|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.83|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 36||37.54|16.83|<0.001
73804583|NCT00615550|147159193|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55||||0.02|TWO_SIDED|95.0|0.33|0.92|||Cochran-Mantel-Haenszel|||||0.92|0.33|0.020
73804584|NCT00615550|147159194|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Cochran-Mantel-Haenszel|||Statistical analysis presented for composite score data.||||0.048
73804585|NCT00615550|147159194|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.39||||0.026|TWO_SIDED|95.0|0.17|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for RDS data.||0.92|0.17|0.026
73804586|NCT00615550|147159195|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5||||0.036|TWO_SIDED|95.0|0.25|0.97|||Cochran-Mantel-Haenszel|||Statistical analysis presented for births \<=27 6/7 weeks data.||0.97|0.25|0.036
73804587|NCT00615550|147159195|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.016|TWO_SIDED|95.0|0.42|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for \<= 34 6/7 weeks data.||0.92|0.42|0.016
73804588|NCT00615550|147159195|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.16|||Cochran-Mantel-Haenszel|||Statistical analysis presented for \<36 weeks data.||1.16|0.68|0.376
73804589|NCT00615550|147159196|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57||||0.431|TWO_SIDED|95.0|0.14|2.35|||Cochran-Mantel-Haenszel|||||2.35|0.14|0.431
73804590|NCT00615550|147159197|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.01|TWO_SIDED|95.0|0.26|0.85|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight \< 1500 grams data.||0.85|0.26|0.01
73804591|NCT00615550|147159197|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.213|TWO_SIDED|95.0|0.62|1.11|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight \< 2500 grams data.||1.11|0.62|0.213
73804592|NCT02640664|147159198|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|2.93|||TWO_SIDED|95.0|-1.1|10.5||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||10.5|-1.1|
73804593|NCT02640664|147159198|SUPERIORITY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-3.4|8.3||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||8.3|-3.4|
73895487|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|31.3|||<|0.001|TWO_SIDED|95.0|21.53|41.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 44||41.02|21.53|<0.001
73804594|NCT02640664|147159198|SUPERIORITY||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|-3.3|7.8||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||7.8|-3.3|
73804595|NCT02640664|147159201|SUPERIORITY||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|4.42|||TWO_SIDED|95.0|-0.8|16.7||P value not applicable because it's a descriptive analysis.|ANOVA|||||16.7|-0.8|
73804596|NCT02640664|147159201|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|4.49|||TWO_SIDED|95.0|-7.3|10.5||P value not applicable because it's a descriptive analysis.|ANOVA|||||10.5|-7.3|
73804597|NCT02640664|147159201|SUPERIORITY||Mean Difference (Net)|6.4|STANDARD_ERROR_OF_MEAN|4.24|||TWO_SIDED|95.0|-2.0|14.8|||ANOVA|||||14.8|-2.0|
73804598|NCT01329380|147159224|OTHER|||||||0.0328|||||||Mann-Whitney U-test|||Age||||0.0328
73804599|NCT01329380|147159224|OTHER|||||||0.7128|||||||Fisher Exact|||Sex||||0.7128
73804600|NCT01329380|147159224|OTHER|||||||0.0465|||||||Mann-Whitney U-test|||Body mass index||||0.0465
73804601|NCT01329380|147159224|OTHER|||||||0.8872|||||||Mann-Whitney U-test|||Duration of illness||||0.8872
73804602|NCT01329380|147159224|OTHER|||||||0.0388|||||||Fisher Exact|||Smoking history||||0.0388
73804603|NCT01329380|147159224|OTHER|||||||0.4855|||||||Fisher Exact|||Complications||||0.4855
73804604|NCT01329380|147159224|OTHER|||||||0.663|||||||Fisher Exact|||Complications - Liver disorder||||0.6630
73804605|NCT01329380|147159224|OTHER|||||||0.2067|||||||Fisher Exact|||Complications - Renal disorder||||0.2067
73804606|NCT01329380|147159224|OTHER|||||||0.8749|||||||Fisher Exact|||Complications - Cardiovascular disorder||||0.8749
73804607|NCT01329380|147159224|OTHER|||||||0.482|||||||Fisher Exact|||Complications - Blood disorder||||0.4820
73804608|NCT01329380|147159224|OTHER|||||||0.6355|||||||Fisher Exact|||Complications - Respiratory disorder||||0.6355
73804609|NCT01329380|147159224|OTHER|||||||0.8193|||||||Fisher Exact|||Complications - Diabetes mellitus||||0.8193
73804610|NCT01329380|147159224|OTHER|||||||0.5723|||||||Fisher Exact|||Complications - Uveitis||||0.5723
73804611|NCT01329380|147159224|OTHER|||||||1|||||||Fisher Exact|||Complications - Inflammatory bowel disease||||1.0000
73804612|NCT01329380|147159224|OTHER|||||||1|||||||Fisher Exact|||Complications - Psoriasis||||1.0000
73804613|NCT01329380|147159224|OTHER|||||||0.0144|||||||Fisher Exact|||Past Illnesses||||0.0144
73804614|NCT01329380|147159224|OTHER|||||||1|||||||Fisher Exact|||Allergy history||||1.0000
73804615|NCT01329380|147159224|OTHER|||||||0.3928|||||||Fisher Exact|||Adalimumab self-injection status||||0.3928
73804616|NCT01329380|147159224|OTHER|||||||0.2735|||||||Fisher Exact|||Prior medications - NSAIDs||||0.2735
73804617|NCT01329380|147159224|OTHER|||||||0.8875|||||||Fisher Exact|||Prior medications - Biological products||||0.8875
73804618|NCT01329380|147159224|OTHER|||||||0.254|||||||Fisher Exact|||Prior medications - Adrenal corticosteroids||||0.2540
73804619|NCT01329380|147159224|OTHER|||||||0.0226|||||||Fisher Exact|||Concomitant drugs||||0.0226
73804620|NCT01329380|147159224|OTHER|||||||1|||||||Fisher Exact|||Concomitant drug: NSAIDs||||1.0000
73804621|NCT01329380|147159224|OTHER|||||||0.2481|||||||Fisher Exact|||Concomitant drugs - DMARDs||||0.2481
73804622|NCT01329380|147159224|OTHER|||||||0.1558|||||||Fisher Exact|||Concomitant drugs - Methotrexate||||0.1558
73804623|NCT01329380|147159224|OTHER|||||||1|||||||Fisher Exact|||Concomitant drugs - salazosulfapyridine||||1.0000
73804624|NCT01329380|147159224|OTHER|||||||0.0094|||||||Fisher Exact|||Concomitant drugs - Adrenal corticosteroids||||0.0094
73804625|NCT01329380|147159224|OTHER|||||||1|||||||Fisher Exact|||Concomitant therapy||||1.0000
73804626|NCT01329380|147159224|OTHER|||||||0.8836|||||||Fisher Exact|||Human leukocyte antigen B27 (HLA-B27) test result||||0.8836
73804627|NCT01329380|147159224|OTHER|||||||1|||||||Fisher Exact|||BASDAI at start of treatment||||1.0000
73804628|NCT01294241|147159266|SUPERIORITY_OR_OTHER||||||=|0.008||||||Post-hoc superiority analysis: Wounds that were either evaluated controversially (n=2) or as being equal (n=2) were excluded from the analysis of the primary efficacy variable.|Two-sided exact binomial test|||The intra-individual difference in reepithelialization of wound (halves) was tested using a two-sided exact binomial test. The test was performed at a significance level of 5% for the null-hypothesis of no difference δ = 0 against the hypotheses δ ≠ 0: H0: δ = 0 H1: δ ≠ 0||||=0.008
73804629|NCT01294241|147159267|SUPERIORITY_OR_OTHER||||||=|0.21||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.||||=0.21
73804630|NCT01294241|147159268|SUPERIORITY_OR_OTHER|||||||0.33||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.||||0.33
73804631|NCT02748213|147159277|SUPERIORITY_OR_OTHER||Difference in Response Rates|2.2||||0.717|TWO_SIDED|95.0|-10.17|14.56|||Chi-squared||The approximate 95% CI for the difference in response (CR or PR) rates was determined using the Hauck-Anderson correction.|||14.56|-10.17|0.717
73804632|NCT02748213|147159279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0449|TWO_SIDED|95.0|0.53|0.99|||Log Rank||Hazard Ratio (HR) calculated using Herceptin + Taxotere arm as reference.|||0.99|0.53|0.0449
73804633|NCT02748213|147159281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.4758|TWO_SIDED|95.0|0.56|1.32|||Log Rank||HR calculated using Herceptin + Taxotere arm as reference.|||1.32|0.56|0.4758
73804634|NCT00961350|147159291|SUPERIORITY_OR_OTHER||Proportions|3.8||||0.02||95.0|1.8|6.8|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.||6.8|1.8|0.020
73804635|NCT00961350|147159292|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||0.002
73804636|NCT00961350|147159293|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
73804637|NCT00961350|147159294|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||0.002
73804638|NCT00961350|147159295|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
73804639|NCT00550745|147159296|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.26||||||95.0|0.91|1.73|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 42 Days postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen \[Comparative analysis of two rates. Stat Med 1985;4:213-26\] method.|||1.73|0.91|
73804640|NCT00550745|147159297|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||||95.0|0.98|1.32|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 6 months postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen \[Comparative analysis of two rates. Stat Med 1985;4:213-26\] method.|||1.32|0.98|
73804641|NCT02640950|147159312|SUPERIORITY||||||<|0.001||||||Paired t test for pre and post treatment scores for all subjects|t-test, 2 sided|||Paired t-test of pre and post treatment scores on MADRS||||<0.001
73804642|NCT02640950|147159313|OTHER|Descriptive Frequencies Analysis|||||||||||||||||A frequencies analysis was conducted to determine the number of participants that were diagnosed with BP I and BP II as well as the number of participants that developed an onset of maniac symptoms during the 7 week treatment period.|||
73804643|NCT02582242|147159344|OTHER||Treatment difference at week 24|-0.09||||0.2601|TWO_SIDED|95.0|-0.23|0.06|||Mixed model for repeated measurements||Treatment difference at week 24: BIAsp 30 (TID) - BIAsp 30 (BID). Number of subjects contributed to the statistical analysis: N=217 for BIAsp 30 (TID) and N=213 for BIAsp 30 (BID).|The analysis was based on a mixed-effect model for repeated measures including changes from baseline in HbA1c at visit 6, 10, 14, 18, 22 and 26 (in week 4, 8, 12, 16, 20 and 24, respectively). The model included treatment, strata and region as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.06|-0.23|0.2601
73804644|NCT00459290|147159369|SUPERIORITY_OR_OTHER|||||||0.7912|||||||Log Rank|||||||0.7912
73804645|NCT00459290|147159370|SUPERIORITY_OR_OTHER|||||||0.1545|||||||Log Rank|||||||0.1545
73804646|NCT00459290|147159371|SUPERIORITY_OR_OTHER|||||||0.0648|||||||Log Rank|||||||0.0648
73804647|NCT01019694|147159426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.02|13.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||13.19|6.02|< 0.0001
73804648|NCT01019694|147159426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.0009||95.0|2.57|9.91|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||9.91|2.57|0.0009
73804649|NCT01019694|147159427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.0006||95.0|2.29|8.28|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||8.28|2.29|0.0006
73804650|NCT01019694|147159427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|||<|0.0001||95.0|4.41|10.39|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||10.39|4.41|< 0.0001
73804651|NCT01019694|147159428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|4.71|11.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||11.09|4.71|< 0.0001
73804652|NCT01019694|147159428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.44|12.83|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||12.83|6.44|< 0.0001
73804653|NCT01019694|147159429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|||<|0.0001||95.0|5.94|12.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||12.37|5.94|< 0.0001
73804654|NCT01019694|147159429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.44|10.96|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||10.96|4.44|< 0.0001
73804655|NCT01019694|147159430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3|||<|0.0001||95.0|7.9|14.76|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||14.76|7.90|< 0.0001
73804656|NCT01019694|147159430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.23|11.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||11.23|4.23|< 0.0001
73804657|NCT01019694|147159432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.1167||95.0|-0.05|0.42|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.42|-0.05|0.1167
73804658|NCT01019694|147159432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0026||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.59|0.13|0.0026
73804659|NCT01019694|147159433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.2826||95.0|-0.11|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.38|-0.11|0.2826
73804660|NCT01019694|147159433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0013||95.0|0.16|0.66|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.66|0.16|0.0013
73804661|NCT01019694|147159434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0023||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.59|0.13|0.0023
73804662|NCT01019694|147159434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.0001||95.0|0.25|0.71|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.71|0.25|< 0.0001
73804663|NCT01019694|147159435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0006||95.0|0.18|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.65|0.18|0.0006
73804664|NCT01019694|147159435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0004||95.0|0.2|0.68|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.68|0.20|0.0004
73804665|NCT01019694|147159436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.0673||95.0|-0.02|0.47|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.47|-0.02|0.0673
73804666|NCT01019694|147159436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.0245||95.0|0.04|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.54|0.04|0.0245
73804667|NCT01019694|147159438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.5695||95.0|-0.24|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.13|-0.24|0.5695
73804668|NCT01019694|147159438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3093||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.09|-0.28|0.3093
73804669|NCT01019694|147159439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3578||95.0|-0.31|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.11|-0.31|0.3578
73804670|NCT01019694|147159439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.7433||95.0|-0.18|0.25|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.25|-0.18|0.7433
73804671|NCT01019694|147159440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.524||95.0|-0.29|0.15|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.15|-0.29|0.524
73804672|NCT01019694|147159440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3171||95.0|-0.34|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.11|-0.34|0.3171
73804673|NCT01019694|147159441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.2499||95.0|-0.38|0.1|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.10|-0.38|0.2499
73804674|NCT01019694|147159441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.6144||95.0|-0.31|0.18|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.18|-0.31|0.6144
73804675|NCT01019694|147159442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.5142||95.0|-0.16|0.33|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.33|-0.16|0.5142
73804676|NCT01019694|147159442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.2691||95.0|-0.39|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.11|-0.39|0.2691
73804677|NCT01019694|147159444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.6236||95.0|-0.23|0.14|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.14|-0.23|0.6236
73804678|NCT01019694|147159444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3342||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.09|-0.28|0.3342
73804679|NCT01019694|147159445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1884||95.0|-0.36|0.07|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.07|-0.36|0.1884
73804680|NCT01019694|147159445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.6978||95.0|-0.17|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.26|-0.17|0.6978
73804681|NCT01019694|147159446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4197||95.0|-0.32|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.13|-0.32|0.4197
73804682|NCT01019694|147159446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3949||95.0|-0.33|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.13|-0.33|0.3949
73804683|NCT01019694|147159447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.299||95.0|-0.38|0.12|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.12|-0.38|0.299
73804684|NCT01019694|147159447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.1404||95.0|-0.44|0.06|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.06|-0.44|0.1404
73804685|NCT01019694|147159448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.463||95.0|-0.36|0.16|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.16|-0.36|0.463
73804686|NCT01019694|147159448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.3824||95.0|-0.15|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.38|-0.15|0.3824
73804687|NCT01019694|147159449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8282||95.0|-0.036|0.045|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.045|-0.036|0.8282
73804688|NCT01019694|147159449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.6587||95.0|-0.032|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.050|-0.032|0.6587
73804689|NCT01019694|147159450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1185||95.0|-0.009|0.081|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.081|-0.009|0.1185
73804690|NCT01019694|147159450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.2651||95.0|-0.02|0.072|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.072|-0.020|0.2651
73804691|NCT01019694|147159451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5852||95.0|-0.058|0.033|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.033|-0.058|0.5852
73804692|NCT01019694|147159451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7242||95.0|-0.054|0.038|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.038|-0.054|0.7242
73804693|NCT01019694|147159452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0328||95.0|0.005|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||||0.110|0.005|0.0328
73804694|NCT01019694|147159452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8896||95.0|-0.058|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.050|-0.058|0.8896
73804695|NCT01019694|147159453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.402||95.0|-0.042|0.105|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.105|-0.042|0.402
73804696|NCT01019694|147159453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.659||95.0|-0.057|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.090|-0.057|0.659
73804697|NCT01019694|147159454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0893||95.0|-0.01|0.139|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.139|-0.010|0.0893
73804698|NCT01019694|147159454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.5424||95.0|-0.052|0.099|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.099|-0.052|0.5424
73895488|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|30.8|||<|0.001|TWO_SIDED|95.0|20.54|41.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 44||41.05|20.54|<0.001
73895489|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.82|35.74|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 52||35.74|16.82|<0.001
73804699|NCT01019694|147159455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6396||95.0|-0.104|0.064|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.064|-0.104|0.6396
73804700|NCT01019694|147159455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6455||95.0|-0.106|0.066|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.066|-0.106|0.6455
73804701|NCT01019694|147159456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.2596||95.0|-0.038|0.141|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.141|-0.038|0.2596
73804702|NCT01019694|147159456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6659||95.0|-0.112|0.071|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.071|-0.112|0.6659
73804703|NCT01019694|147159458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.476||95.0|-0.4|0.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.19|-0.40|0.476
73804704|NCT01019694|147159458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.6976||95.0|-0.35|0.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.23|-0.35|0.6976
73804705|NCT01019694|147159459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9506||95.0|-0.4|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.37|-0.40|0.9506
73804706|NCT01019694|147159459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.2362||95.0|-0.15|0.62|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.62|-0.15|0.2362
73804707|NCT01019694|147159460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.5645||95.0|-0.3|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.54|-0.30|0.5645
73804708|NCT01019694|147159460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.0163||95.0|0.1|0.95|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.95|0.10|0.0163
73804709|NCT01019694|147159461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.4339||95.0|-0.6|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.26|-0.60|0.4339
73804710|NCT01019694|147159461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.4886||95.0|-0.28|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.59|-0.28|0.4886
73804711|NCT01019694|147159462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7637||95.0|-0.5|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.37|-0.50|0.7637
73804712|NCT01019694|147159462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.3755||95.0|-0.24|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.65|-0.24|0.3755
73804713|NCT04244084|147159469|SUPERIORITY||Median Difference (Final Values)|-0.89||||0.0155|TWO_SIDED|95.0|-1.61|-0.17|||ANCOVA|Site used as covariate||Mean differences (MMH-407 vs. Placebo) were compared||-0.17|-1.61|0.0155
73804714|NCT04244084|147159470|SUPERIORITY|||||||0.1839|||||||Wilcoxon (Mann-Whitney)|||||||0.1839
73804715|NCT04244084|147159471|SUPERIORITY|||||||0.064||||||Day used as independent strata.|Cochran-Mantel-Haenszel|||||||0.0640
73804716|NCT04244084|147159472|SUPERIORITY|||||||0.1927|||||||Wilcoxon (Mann-Whitney)|||||||0.1927
73804717|NCT04244084|147159473|SUPERIORITY|||||||0.0014||||||Day used as independent strata.|Cochran-Mantel-Haenszel|||||||0.0014
73804718|NCT04244084|147159474|SUPERIORITY|||||||0.2009|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 1 row."||||0.2009
73804719|NCT04244084|147159474|SUPERIORITY|||||||0.4717|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 2 row."||||0.4717
73804720|NCT04244084|147159474|SUPERIORITY|||||||0.5144|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 3 row."||||0.5144
73804721|NCT04244084|147159475|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
73804722|NCT04244084|147159477|SUPERIORITY|||||||0.5981|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 1 row."||||0.5981
73895490|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|27.0|||<|0.001|TWO_SIDED|95.0|16.63|37.44|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 52||37.44|16.63|<0.001
73804723|NCT04244084|147159477|SUPERIORITY|||||||0.4913|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 2 row."||||0.4913
73804724|NCT04244084|147159477|SUPERIORITY|||||||0.6441|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 3 row."||||0.6441
73804725|NCT04244084|147159477|SUPERIORITY|||||||0.8186|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 1 row."||||0.8186
73804726|NCT04244084|147159477|SUPERIORITY|||||||0.8931|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 2 row."||||0.8931
73804727|NCT04244084|147159477|SUPERIORITY|||||||0.5887|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 3 row."||||0.5887
73804728|NCT04244084|147159478|SUPERIORITY|||||||0.4426|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 1 row."||||0.4426
73804729|NCT04244084|147159478|SUPERIORITY|||||||0.5998|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 2 row."||||0.5998
73804730|NCT04244084|147159478|SUPERIORITY|||||||0.971|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 3 row."||||0.9710
73804731|NCT04244084|147159479|SUPERIORITY|||||||0.6197|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 1 row."||||0.6197
73804732|NCT04244084|147159479|SUPERIORITY|||||||0.7042|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 2 row."||||0.7042
73804733|NCT04244084|147159479|SUPERIORITY|||||||0.7693|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 3 row."||||0.7693
73804734|NCT04244084|147159480|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73804735|NCT04632069|147159499|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|0.4||0.009|TWO_SIDED||||||Regression, Linear|repeated measures linear regression: time periods: -14 to Day 0, Day 1-18(independent variable); daily po volumes (Dependent Variable)||Daily change in po feeding volumes expressed as po ml/kg/d \[reported as the mean daily change from Day 1 to 18 during NAC/NAC+taVNS minus baseline mean daily change Day -14 to day 0 (before treatment)\] Null hypothesis: there will be no significant difference in daily change in po feeding volume (ml/kg/d) from baseline to during treatment Power analysis: Estimated +0.2 ml/kg/d before taVNS, and +3ml/kg/d during the 18days of NAC+taVNS treatment, requiring 10 infants with power of 80%, a=0.05.||||0.009
73804736|NCT04632069|147159500|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|0.08||0.01|TWO_SIDED||||||t-test, 2 sided|paired t-test|mean difference between \[GSH\] Day 4 of NAC and \[GSH\] at baseline|\[GSH\] at baseline compared with \[GSH\] at day 4 of NAC- by paired t-test in which each participant's \[GSH\] is compared at 2 time points Null hypothesis: the \[GSH\] in the basal ganglia will be no different after Day 4 of NAC than \[GSH\] at baseline Power calculation:With 80% power, alpha of 0.05, we would need 7 patients to show a significant change in basal ganglia \[GSH\] of 0.14 +/- 0.13mM from baseline to Day 4 of NAC (paired t-test).||||0.01
73804737|NCT03421210|147159501|OTHER|||||||0.001|||||||t-test, 1 sided|||Differences in brain activation in response to personal smoking versus standard smoking cues were examined.||||0.001
73804738|NCT03412734|147159504|OTHER||Odds Ratio (OR)|10.6|||<|0.001|TWO_SIDED|95.0|3.02|37.34||p-value is adjusted for baseline BV (Bacterial Vaginosis)|Regression, Logistic|||We hypothesized that chlorhexidine would have a lower bacterial count compared to iodine. Our sample size was calculated to be 71 patients per arm to detect a 22% difference in cultures defined as contaminated at 90 minutes from surgical preparation.||37.34|3.02|<0.001
73804739|NCT03777436|147159523|SUPERIORITY||Adjusted difference|20.1||||0.0003|TWO_SIDED|95.0|9.2|30.9|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||30.9|9.2|0.0003
73895491|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0||||0.766|TWO_SIDED|95.0|-1.69|1.65|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 24||1.65|-1.69|0.766
73804740|NCT03777436|147159524|SUPERIORITY||Adjusted difference|15.2||||0.0004|TWO_SIDED|95.0|6.9|23.6|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||23.6|6.9|0.0004
73804741|NCT03777436|147159525|SUPERIORITY||Adjusted difference|27.4|||<|0.0001|TWO_SIDED|95.0|15.4|39.3|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||39.3|15.4|<0.0001
73804742|NCT03777436|147159526|SUPERIORITY||Least squares mean difference|-3.33|STANDARD_ERROR_OF_MEAN|0.942||0.0005|TWO_SIDED|95.0|-5.18|-1.47|||MMRM||Based on MMRM model.|||-1.47|-5.18|0.0005
73804743|NCT03777436|147159527|SUPERIORITY||Least squares mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0008|TWO_SIDED|95.0|-4.2|-1.1|||MMRM||Based on MMRM model.|||-1.1|-4.2|0.0008
73804744|NCT03777436|147159528|SUPERIORITY||Difference|-15.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|-20.3|-10.0|||MMRM||Based on MMRM model.|||-10.0|-20.3|<0.0001
73804745|NCT00676364|147159530|NON_INFERIORITY_OR_EQUIVALENCE|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.|Mean Difference (Final Values)|2.1||||0.71|||||||Chi-squared||To assess the association between pain and anxiety with intervention group while controlling for other factors, linear regression was used.|P-value determined from linear regression models that include age, gender, number of needle sticks in previous 2 years and nurse reported difficulty in performing venipuncture.||||0.71
73804746|NCT01342770|147159553|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Signed Rank|||||||0.06
73804747|NCT00402688|147159598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.063||||||95.0|-0.089|0.215|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 2 weeks ).|||0.215|-0.089|
73804748|NCT00402688|147159598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.045||||||95.0|-0.106|0.195|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 3 weeks).|||0.195|-0.106|
73804749|NCT02347774|147159604|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.0736|STANDARD_ERROR_OF_MEAN|0.01989||0.0002|TWO_SIDED|95.0|0.0346|0.1127|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1127|0.0346|0.0002
73804750|NCT02347774|147159604|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.081|STANDARD_ERROR_OF_MEAN|0.02006||0.0001|TWO_SIDED|95.0|0.0416|0.1204|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1204|0.0416|0.0001
73804751|NCT02347774|147159605|SUPERIORITY||Least Mean Squared (SE)|0.082|STANDARD_ERROR_OF_MEAN|0.02055|<|0.0001|TWO_SIDED|95.0|0.0417|0.1224||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|I||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1224|0.0417|<0.0001
73804752|NCT02347774|147159605|SUPERIORITY||Least Mean Squared (SE)|0.084|STANDARD_ERROR_OF_MEAN|0.02069||0.0001|TWO_SIDED|95.0|0.0433|0.1246||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1246|0.0433|0.0001
73804753|NCT00921557|147159620|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 24||||<0.001
73804754|NCT00921557|147159620|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 48||||<0.001
73804755|NCT00921557|147159621|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||||||Not adjusted for multiple comparisons|Fisher Exact|||Comparison of percentage of participants experiencing primary safety outcome||||>0.99
73804756|NCT04157296|147159655|SUPERIORITY||Mean Difference (Final Values)|-0.226|||||TWO_SIDED|||||||||leftIFG (Change in Brain activity \[post minus pre\])||||
73895492|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in Proportions|8.2||||0.091|TWO_SIDED|95.0|2.32|14.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 28||14.10|2.32|0.091
73804757|NCT04157296|147159655|SUPERIORITY||Median Difference (Final Values)|-0.309|||||TWO_SIDED|||||||||rightIFG (Change in Brain activity \[post minus pre\])||||
73804758|NCT04157296|147159655|SUPERIORITY||Mean Difference (Final Values)|-0.179|||||TWO_SIDED|||||||||leftParietal (Change in Brain activity \[post minus pre\])||||
73804759|NCT04157296|147159655|SUPERIORITY||Mean Difference (Final Values)|0.324|||||TWO_SIDED|||||||||rightParietal (Change in Brain activity \[post minus pre\])||||
73804760|NCT04157296|147159655|SUPERIORITY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|||||||||leftdACC (Change in Brain activity \[post minus pre\])||||
73804761|NCT04157296|147159655|SUPERIORITY||Mean Difference (Final Values)|-0.067|||||TWO_SIDED|||||||||rightdACC (Change in Brain activity \[post minus pre\])||||
73804762|NCT04157296|147159655|SUPERIORITY||Mean Difference (Final Values)|0.302|||||TWO_SIDED|||||||||leftInsula (Change in Brain activity \[post minus pre\])||||
73804763|NCT04157296|147159655|SUPERIORITY|rightInsula (Change in Brain activity \[post minus pre\])|Mean Difference (Final Values)|0.234|||||TWO_SIDED|||||||||rightInsula (Change in Brain activity \[post minus pre\])||||
73804764|NCT04157296|147159655|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|||||||||TCN (Change in Connectivity \[post minus pre\])||||
73804765|NCT04157296|147159656|SUPERIORITY|||||||0.241|||||||t-test, 1 sided|||||||0.241
73804766|NCT04157296|147159657|SUPERIORITY|||||||0.233|||||||t-test, 1 sided|||||||0.233
73804767|NCT04157296|147159658|SUPERIORITY|||||||0.042|||||||t-test, 1 sided|||||||0.042
73804768|NCT04157296|147159659|SUPERIORITY|||||||0.349|||||||t-test, 1 sided|||||||0.349
73804769|NCT02484456|147159665|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.79||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
73804770|NCT02484456|147159666|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.72||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
73895493|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|6.5||||0.227|TWO_SIDED|95.0|1.28|11.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 28||11.75|1.28|0.227
73804771|NCT02484456|147159667|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.89||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
73804772|NCT02484456|147159668|SUPERIORITY||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.06||0.25|TWO_SIDED||||||Mixed Models Analysis|||||||0.25
73804773|NCT02484456|147159669|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.27||0.51|TWO_SIDED||||||Mixed Models Analysis|||||||0.51
73804774|NCT02484456|147159670|SUPERIORITY||Mean Difference (Final Values)|-1.83|STANDARD_ERROR_OF_MEAN|1.58||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
73804775|NCT02484456|147159671|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.02||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
73804776|NCT02484456|147159672|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|1.34||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
73804777|NCT02484456|147159673|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.2||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
73804778|NCT02484456|147159674|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.51||0.51|TWO_SIDED||||||Mixed Models Analysis|||||||0.51
73804779|NCT02484456|147159675|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.76||0.37|TWO_SIDED||||||Mixed Models Analysis|||||||0.37
73804780|NCT02484456|147159676|SUPERIORITY||Mean Difference (Final Values)|-2.02|STANDARD_ERROR_OF_MEAN|1.89||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.29
73804781|NCT02484456|147159677|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.92||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
73804782|NCT02484456|147159678|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.98||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
73804783|NCT02484456|147159679|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.1||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.88
73804784|NCT02484456|147159680|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.91||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
73804785|NCT02484456|147159681|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|1.3||0.38|TWO_SIDED||||||Mixed Models Analysis|||||||0.38
73804786|NCT02484456|147159682|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|1.26||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
73804787|NCT02484456|147159683|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.98||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
73804788|NCT02484456|147159684|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.23||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
73804789|NCT02484456|147159685|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|1.39||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.81
73804790|NCT02484456|147159686|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.31||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
73804791|NCT02484456|147159687|SUPERIORITY||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|1.89||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.35
73804792|NCT02484456|147159688|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|1.63||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
73804793|NCT01757184|147159734|SUPERIORITY|||||||0.0271|||||||Fisher Exact|Fisher's exact test at α=0.05.||A sample size of 50 randomized participants (approximately 25 participants per treatment group) provided 97% power to detect a statistically significant difference between sebelipase alfa and placebo, using Fisher's exact test at α=0.05.||||0.0271
73804794|NCT01757184|147159735|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73804795|NCT01757184|147159736|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73804796|NCT01757184|147159737|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||||||0.0003
73804797|NCT01757184|147159738|SUPERIORITY|||||||0.0375|||||||Wilcoxon (Mann-Whitney)|||||||0.0375
73804798|NCT01757184|147159739|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73804799|NCT01757184|147159740|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73804800|NCT01757184|147159741|SUPERIORITY|||||||0.4216|||||||Fisher Exact|||||||0.4216
73804801|NCT01757184|147159742|SUPERIORITY|||||||0.0068|||||||Wilcoxon (Mann-Whitney)|||||||0.0068
73804802|NCT00554515|147159743|SUPERIORITY|Comparison against historical control ORR of 14%.||||||0.042|||||||exact binomial test|||||||0.042
73804803|NCT00554515|147159744|SUPERIORITY|||||||0.39|||||||Fisher Exact|||Objective response rates were compared between ISM good and poor risk subgroups. ISM good risk ORR reported under primary endpoint.||||0.39
73804804|NCT00554515|147159745|SUPERIORITY|||||||0.0014|||||||exact binomial test|||Test against the historical ORR was conducted in the overall study population as secondary analyses.||||0.0014
73804805|NCT00554515|147159748|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between MSKCC subgroups.||||.89
73804806|NCT00554515|147159750|SUPERIORITY|||||||0.33|||||||Fisher Exact|||Objective response rates were compared between tumor type subgroups||||.33
73804807|NCT00554515|147159751|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between clear cell histology subgroups||||.89
73804808|NCT00554515|147159752|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Objective response rates were compared between CA-9 score subgroups||||.19
73804809|NCT00554515|147159753|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Objective response rates were compared between PD-L1 tumor subgroups||||0.01
73804810|NCT00554515|147159754|SUPERIORITY|||||||0.08|||||||Fisher Exact|||Objective response rates were compared between B7-H3 tumor subgroups||||.08
73804811|NCT00554515|147159755|SUPERIORITY|||||||0.28|||||||Fisher Exact|||Objective response rates were compared between CA-9 SNP subgroups||||.28
73804812|NCT01554527|147159771|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.07
73804813|NCT01554527|147159772|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.34
73804814|NCT01554527|147159773|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.93
73895494|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|9.9||||0.072|TWO_SIDED|95.0|3.27|16.6|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 36||16.60|3.27|0.072
73804815|NCT01554527|147159774|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.5
73804816|NCT01554527|147159775|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.25
73804817|NCT01052480|147159779|SUPERIORITY_OR_OTHER|||||||0.069|||||||Log Rank|||||||0.069
73804818|NCT00529373|147159801|OTHER||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.4|0.53|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.||0.53|0.40|<0.001
73804819|NCT00529373|147159802|OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.71|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.71|0.39|<0.001
73804820|NCT00529373|147159803|OTHER||Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.68|0.87|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.87|0.68|<0.001
73804821|NCT00529373|147159804|OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.42|0.55|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.||0.55|0.42|<0.001
73804822|NCT00529373|147159805|OTHER||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.4|0.67|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.67|0.40|<0.001
73804823|NCT00529373|147159806|OTHER||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.66|0.83|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.83|0.66|<0.001
73804824|NCT00529373|147159807|OTHER|Miettinen \& Nurminen|Difference in rates|0.88|||||TWO_SIDED|95.0|-2.3|4.07||||||||4.07|-2.3|
73804825|NCT00529373|147159808|OTHER|Miettinen \& Nurminen|Difference in rates|0.11|||||TWO_SIDED|95.0|-0.16|0.37||||||||0.37|-0.16|
73804826|NCT00529373|147159812|OTHER||Difference in Least Squares Means|8.92|||<|0.001|TWO_SIDED|95.0|3.9|13.93|||Longitudinal model|||Odanacatib 50 mg vs Placebo||13.93|3.9|<0.001
73804827|NCT00529373|147159813|OTHER||Difference in Least Squares Means|26.45|||<|0.001|TWO_SIDED|95.0|16.49|36.4|||Longitudinal model|||Odanacatib 50 mg vs Placebo||36.40|16.49|<0.001
73804828|NCT00529373|147159814|OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.14|0.09||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.09|-0.14|
73804829|NCT00529373|147159814|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.12|0.12||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.12|-0.12|
73804830|NCT00529373|147159814|OTHER||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.17|0.09||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.09|-0.17|
73804831|NCT00529373|147159814|OTHER||Mean Difference (Final Values)|-0.21|||||TWO_SIDED|95.0|-0.5|0.08||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.08|-0.50|
73804832|NCT00529373|147159815|OTHER||Difference in Least Squares Means|0.11|||||TWO_SIDED|95.0|-0.16|0.38||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.38|-0.16|
73804833|NCT00529373|147159815|OTHER||Difference in Least Squares Means|0.14|||||TWO_SIDED|95.0|-0.15|0.44||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.44|-0.15|
73804834|NCT00529373|147159815|OTHER||Difference in Least Squares Means|0.19|||||TWO_SIDED|95.0|-0.15|0.54||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.54|-0.15|
73804835|NCT00529373|147159815|OTHER||Difference in Least Squares Means|0.19|||||TWO_SIDED|95.0|-0.24|0.62||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.62|-0.24|
73804836|NCT00529373|147159816|OTHER||Difference in Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.08|0.15||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.15|-0.08|
73804837|NCT00529373|147159816|OTHER||Difference in Least Squares Means|0.08|||||TWO_SIDED|95.0|-0.06|0.21||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.21|-0.06|
73804838|NCT00529373|147159816|OTHER||Difference in Least Squares Means|0.03|||||TWO_SIDED|95.0|-0.12|0.17||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.17|-0.12|
73804839|NCT00529373|147159816|OTHER||Difference in Least Squares Means|0.09|||||TWO_SIDED|95.0|-0.09|0.28||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.28|-0.09|
73804840|NCT00529373|147159817|OTHER|Miettinen \& Nurminen|Difference in rates|1.52|||||TWO_SIDED|95.0|-1.8|4.84||||||||4.84|-1.8|
73804841|NCT00529373|147159818|OTHER|Miettinen \& Nurminen|Difference in rates|0.27|||||TWO_SIDED|95.0|-0.04|0.58||||||||0.58|-0.04|
73804842|NCT00529373|147159819|OTHER||Hazard Ratio (HR)|0.28|||<|0.001|TWO_SIDED|95.0|0.19|0.4|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.40|0.19|<0.001
73804843|NCT00529373|147159820|OTHER||Difference in Least Squares Means|0.01||||0.041|TWO_SIDED|95.0|0.0|0.03|||Mixed Models Analysis|||Odanacatib 50 mg OW versus Placebo. The mixed model contained fixed effects for treatment, region, stratum, treatment-year interaction and random effect intercept and slope (year) and unstructured covariance matrix.||0.03|0.00|0.041
73804844|NCT00529373|147159821|OTHER||Odds Ratio (OR)|0.89||||0.014|TWO_SIDED|95.0|0.81|0.98|||Logistic model|||Odanacatib 50 mg OW versus Placebo. Treatment comparison for height loss at any time during the treatment period. The logistic model contained terms for treatment, geographic region and stratum.||0.98|0.81|0.014
73804845|NCT00529373|147159822|OTHER||Difference in Least Squares Means|1.32|||<|0.001|TWO_SIDED|95.0|0.9|1.75|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.75|0.90|<0.001
73804846|NCT00529373|147159822|OTHER||Difference in Least Squares Means|2.49|||<|0.001|TWO_SIDED|95.0|2.37|2.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.61|2.37|<0.001
73804847|NCT00529373|147159822|OTHER||Difference in Least Squares Means|4.47|||<|0.001|TWO_SIDED|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.62|4.31|<0.001
73804848|NCT00529373|147159822|OTHER||Difference in Least Squares Means|6.44|||<|0.001|TWO_SIDED|95.0|6.25|6.64|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.64|6.25|<0.001
73804849|NCT00529373|147159822|OTHER||Difference in Least Squares Means|8.62|||<|0.001|TWO_SIDED|95.0|8.11|9.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.12|8.11|<0.001
73804850|NCT00529373|147159822|OTHER||Difference in Least Squares Means|9.49|||<|0.001|TWO_SIDED|95.0|8.7|10.29|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.29|8.70|<0.001
73804851|NCT00529373|147159823|OTHER||Difference in Least Squares Means|2.96|||<|0.001|TWO_SIDED|95.0|2.47|3.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.46|2.47|<0.001
73804852|NCT00529373|147159823|OTHER||Difference in Least Squares Means|4.07|||<|0.001|TWO_SIDED|95.0|3.93|4.22|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.22|3.93|<0.001
73804853|NCT00529373|147159823|OTHER||Difference in Least Squares Means|6.05|||<|0.001|TWO_SIDED|95.0|5.87|6.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.23|5.87|<0.001
73804854|NCT00529373|147159823|OTHER||Difference in Least Squares Means|7.84|||<|0.001|TWO_SIDED|95.0|7.62|8.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.06|7.62|<0.001
73804855|NCT00529373|147159823|OTHER||Difference in Least Squares Means|9.72|||<|0.001|TWO_SIDED|95.0|9.16|10.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.27|9.16|<0.001
73804856|NCT00529373|147159823|OTHER||Difference in Least Squares Means|11.23|||<|0.001|TWO_SIDED|95.0|10.23|12.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||12.23|10.23|<0.001
73804857|NCT00529373|147159824|OTHER||Difference in Least Squares Means|1.49|||<|0.001|TWO_SIDED|95.0|0.95|2.03|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.03|0.95|<0.001
73804858|NCT00529373|147159824|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.37|2.05|<0.001
73804859|NCT00529373|147159824|OTHER||Difference in Least Squares Means|4.38|||<|0.001|TWO_SIDED|95.0|4.19|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|4.19|<0.001
73804860|NCT00529373|147159824|OTHER||Difference in Least Squares Means|6.46|||<|0.001|TWO_SIDED|95.0|6.24|6.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.68|6.24|<0.001
73804861|NCT00529373|147159824|OTHER||Difference in Least Squares Means|8.42|||<|0.001|TWO_SIDED|95.0|7.82|9.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.02|7.82|<0.001
73804862|NCT00529373|147159824|OTHER||Difference in Least Squares Means|8.53|||<|0.001|TWO_SIDED|95.0|7.54|9.53|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.53|7.54|<0.001
73804863|NCT00529373|147159825|OTHER||Difference in Least Squares Means|1.74|||<|0.001|TWO_SIDED|95.0|1.03|2.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.46|1.03|<0.001
73804864|NCT00529373|147159825|OTHER||Difference in Least Squares Means|3.5|||<|0.001|TWO_SIDED|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.70|3.31|<0.001
73804865|NCT00529373|147159825|OTHER||Difference in Least Squares Means|6.41|||<|0.001|TWO_SIDED|95.0|6.17|6.65|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 24||6.65|6.17|<0.001
73804866|NCT00529373|147159825|OTHER||Difference in Least Squares Means|9.27|||<|0.001|TWO_SIDED|95.0|8.98|9.57|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 36||9.57|8.98|<0.001
73804867|NCT00529373|147159825|OTHER||Difference in Least Squares Means|12.44|||<|0.001|TWO_SIDED|95.0|11.66|13.22|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 48||13.22|11.66|<0.001
73804868|NCT00529373|147159825|OTHER||Difference in Least Squares Means|13.81|||<|0.001|TWO_SIDED|95.0|12.58|15.04|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 60||15.04|12.58|<0.001
73804869|NCT00529373|147159826|OTHER||Difference in Least Squares Means|1.11|||<|0.001|TWO_SIDED|95.0|0.67|1.55|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.55|0.67|<0.001
73804870|NCT00529373|147159826|OTHER||Difference in Least Squares Means|1.35|||<|0.001|TWO_SIDED|95.0|0.85|1.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.84|0.85|<0.001
73804871|NCT00529373|147159826|OTHER||Difference in Least Squares Means|1.93|||<|0.001|TWO_SIDED|95.0|1.38|2.47|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.47|1.38|<0.001
73804872|NCT00529373|147159826|OTHER||Difference in Least Squares Means|2.2||||0.001|TWO_SIDED|95.0|0.89|3.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.51|0.89|0.001
73804873|NCT00529373|147159826|OTHER||Difference in Least Squares Means|3.5||||0.001|TWO_SIDED|95.0|1.46|5.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||5.54|1.46|0.001
73804874|NCT00529373|147159827|OTHER||Difference in Least Squares Means|5.79|||<|0.001|TWO_SIDED|95.0|5.37|6.2|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.2|5.37|<0.001
73804875|NCT00529373|147159827|OTHER||Difference in Least Squares Means|4.02|||<|0.001|TWO_SIDED|95.0|3.67|4.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.37|3.67|<0.001
73804876|NCT00529373|147159827|OTHER||Difference in Least Squares Means|7.62|||<|0.001|TWO_SIDED|95.0|7.11|8.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.13|7.11|<0.001
73804877|NCT00529373|147159827|OTHER||Difference in Least Squares Means|9.51|||<|0.001|TWO_SIDED|95.0|7.96|11.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.06|7.96|<0.001
73804878|NCT00529373|147159828|OTHER||Difference in Least Squares Means|2.4|||<|0.001|TWO_SIDED|95.0|2.11|2.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.68|2.11|<0.001
73804879|NCT00529373|147159828|OTHER||Difference in Least Squares Means|4.21|||<|0.001|TWO_SIDED|95.0|3.84|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|3.84|<0.001
73804880|NCT00529373|147159828|OTHER||Difference in Least Squares Means|5.86|||<|0.001|TWO_SIDED|95.0|5.41|6.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.30|5.41|<0.001
73804881|NCT00529373|147159828|OTHER||Difference in Least Squares Means|8.54|||<|0.001|TWO_SIDED|95.0|7.0|10.09|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.09|7.00|<0.001
73804882|NCT00529373|147159829|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|1.83|2.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.59|1.83|<0.001
73804883|NCT00529373|147159829|OTHER||Difference in Least Squares Means|4.33|||<|0.001|TWO_SIDED|95.0|3.87|4.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.78|3.87|<0.001
73804884|NCT00529373|147159829|OTHER||Difference in Least Squares Means|6.09|||<|0.001|TWO_SIDED|95.0|5.56|6.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.62|5.56|<0.001
73804885|NCT00529373|147159829|OTHER||Difference in Least Squares Means|9.08|||<|0.001|TWO_SIDED|95.0|6.97|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.19|6.97|<0.001
73804886|NCT00529373|147159830|OTHER||Difference in Least Squares Means|3.44|||<|0.001|TWO_SIDED|95.0|2.98|3.9|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 12||3.90|2.98|<0.001
73804887|NCT00529373|147159830|OTHER||Difference in Least Squares Means|6.03|||<|0.001|TWO_SIDED|95.0|5.47|6.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.59|5.47|<0.001
73804888|NCT00529373|147159830|OTHER||Difference in Least Squares Means|8.49|||<|0.001|TWO_SIDED|95.0|7.81|9.16|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.16|7.81|<0.001
73804889|NCT00529373|147159830|OTHER||Difference in Least Squares Means|11.76|||<|0.001|TWO_SIDED|95.0|9.15|14.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||14.36|9.15|<0.001
73804890|NCT00529373|147159831|OTHER||Difference in Least Squares Means|1.08||||0.083|TWO_SIDED|95.0|-0.14|2.31|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.31|-0.14|0.083
73804891|NCT00529373|147159831|OTHER||Difference in Least Squares Means|1.05||||0.129|TWO_SIDED|95.0|-0.31|2.4|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.40|-0.31|0.129
73804892|NCT00529373|147159831|OTHER||Difference in Least Squares Means|1.21||||0.104|TWO_SIDED|95.0|-0.25|2.67|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.67|-0.25|0.104
73804893|NCT00529373|147159831|OTHER||Difference in Least Squares Means|1.55||||0.617|TWO_SIDED|95.0|-4.92|8.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.02|-4.92|0.617
73804894|NCT00529373|147159832|OTHER||Difference in Least Squares Means|-58.99|||<|0.001|TWO_SIDED|95.0|-64.68|-53.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.||-53.30|-64.68|<0.001
73804895|NCT00529373|147159832|OTHER||Difference in Least Squares Means|-60.01|||<|0.001|TWO_SIDED|95.0|-66.4|-53.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.||-53.61|-66.40|<0.001
73804896|NCT00529373|147159832|OTHER||Difference in Least Squares Means|-46.7|||<|0.001|TWO_SIDED|95.0|-53.23|-40.17|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.||-40.17|-53.23|<0.001
73804897|NCT00529373|147159832|OTHER||Difference in Least Squares Means|-44.67||||0.05|TWO_SIDED|95.0|-52.62|-36.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.||-36.72|-52.62|0.050
73804898|NCT00529373|147159832|OTHER||Difference in Least Squares Means|-18.73||||0.05|TWO_SIDED|95.0|-37.44|-0.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.||-0.01|-37.44|0.050
73804899|NCT00529373|147159833|OTHER||Difference in Least Squares Means|-51.7|||<|0.001|TWO_SIDED|95.0|-56.11|-47.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.||-47.28|-56.11|<0.001
73804900|NCT00529373|147159833|OTHER||Difference in Least Squares Means|-53.59|||<|0.001|TWO_SIDED|95.0|-58.39|-48.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.||-48.79|-58.39|<0.001
73804901|NCT00529373|147159833|OTHER||Difference in Least Squares Means|-56.68|||<|0.001|TWO_SIDED|95.0|-62.52|-50.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.||-50.84|-62.52|<0.001
73804902|NCT00529373|147159833|OTHER||Difference in Least Squares Means|-59.14|||<|0.001|TWO_SIDED|95.0|-66.04|-52.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.||-52.23|-66.04|<0.001
73804903|NCT00529373|147159833|OTHER||Difference in Least Squares Means|-44.54|||<|0.001|TWO_SIDED|95.0|-61.72|-27.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.||-27.36|-61.72|<0.001
73804904|NCT00529373|147159834|OTHER||Mean Difference (Final Values)|-14.13|||<|0.001|TWO_SIDED|95.0|-17.0|-11.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-11.27|-17.00|<0.001
73804905|NCT00529373|147159834|OTHER||Mean Difference (Final Values)|-12.01|||<|0.001|TWO_SIDED|95.0|-15.22|-8.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-8.79|-15.22|<0.001
73804906|NCT00529373|147159834|OTHER||Mean Difference (Final Values)|-9.29|||<|0.001|TWO_SIDED|95.0|-13.45|-5.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-5.13|-13.45|<0.001
73804907|NCT00529373|147159834|OTHER||Mean Difference (Final Values)|-7.64|||<|0.001|TWO_SIDED|95.0|-11.87|-3.41|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-3.41|-11.87|<0.001
73804908|NCT00529373|147159834|OTHER||Mean Difference (Final Values)|-0.77||||0.896|TWO_SIDED|95.0|-12.34|10.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||10.79|-12.34|0.896
73804909|NCT00529373|147159835|OTHER||Mean Difference (Final Values)|-29.43|||<|0.001|TWO_SIDED|95.0|-33.47|-25.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-25.39|-33.47|<0.001
73804910|NCT00529373|147159835|OTHER||Mean Difference (Final Values)|-25.94|||<|0.001|TWO_SIDED|95.0|-30.54|-21.34|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-21.34|-30.54|<0.001
73804911|NCT00529373|147159835|OTHER||Mean Difference (Final Values)|-16.26|||<|0.001|TWO_SIDED|95.0|-21.41|-11.12|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-11.12|-21.41|<0.001
73804912|NCT00529373|147159835|OTHER||Mean Difference (Final Values)|-12.11|||<|0.001|TWO_SIDED|95.0|-18.03|-6.19|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-6.19|-18.03|<0.001
73804913|NCT00529373|147159835|OTHER||Mean Difference (Final Values)|-3.34||||0.61|TWO_SIDED|95.0|-16.12|9.45|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||9.45|-16.12|0.610
73895495|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|8.8||||0.108|TWO_SIDED|95.0|2.43|15.2|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 36||15.20|2.43|0.108
73804914|NCT00529373|147159836|OTHER||Hazard Ratio (HR)|1.12||||0.182|TWO_SIDED|95.0|0.95|1.34|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.34|0.95|0.182
73804915|NCT00529373|147159837|OTHER||Hazard Ratio (HR)|1.18||||0.235|TWO_SIDED|95.0|0.9|1.55|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.55|0.9|0.235
73804916|NCT00529373|147159838|OTHER||Hazard Ratio (HR)|1.12||||0.127|TWO_SIDED|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.29|0.97|0.127
73804917|NCT00529373|147159839|OTHER||Hazard Ratio (HR)|1.06||||0.857|TWO_SIDED|95.0|0.59|1.89|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.89|0.59|0.857
73804918|NCT00529373|147159840|OTHER||Hazard Ratio (HR)|1.1||||0.606|TWO_SIDED|95.0|0.76|1.59|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.59|0.76|0.606
73804919|NCT00529373|147159841|OTHER||Hazard Ratio (HR)|1.25||||0.074|TWO_SIDED|95.0|0.98|1.6|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.6|0.98|0.074
73804920|NCT00529373|147159842|OTHER||Hazard Ratio (HR)|1.12||||0.127|TWO_SIDED|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.29|0.97|0.127
73804921|NCT00529373|147159843|OTHER||Hazard Ratio (HR)|1.16||||0.277|TWO_SIDED|95.0|0.89|1.52|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.52|0.89|0.277
73804922|NCT00529373|147159844|OTHER||Hazard Ratio (HR)|0.82||||0.256|TWO_SIDED|95.0|0.58|1.15|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.15|0.58|0.256
73804923|NCT00529373|147159845|OTHER||Hazard Ratio (HR)|0.86||||0.794|TWO_SIDED|95.0|0.29|2.57|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.57|0.29|0.794
73804924|NCT00529373|147159846|OTHER||Hazard Ratio (HR)|1.32||||0.034|TWO_SIDED|95.0|1.02|1.7|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.7|1.02|0.034
73804925|NCT00529373|147159847|OTHER||Hazard Ratio (HR)|1.91||||0.081|TWO_SIDED|95.0|0.93|3.97|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||3.97|0.93|0.081
73804926|NCT00529373|147159848|OTHER||Difference in Least Squares Means|1.47|||<|0.001|TWO_SIDED|95.0|0.92|2.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.01|0.92|<0.001
73804927|NCT00529373|147159848|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.37|2.05|<0.001
73804928|NCT00529373|147159848|OTHER||Difference in Least Squares Means|4.39|||<|0.001|TWO_SIDED|95.0|4.2|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|4.20|<0.001
73804929|NCT00529373|147159848|OTHER||Difference in Least Squares Means|6.5|||<|0.001|TWO_SIDED|95.0|6.28|6.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.72|6.28|<0.001
73804930|NCT00529373|147159848|OTHER||Difference in Least Squares Means|8.29|||<|0.001|TWO_SIDED|95.0|8.02|8.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.57|8.02|<0.001
73804931|NCT00529373|147159848|OTHER||Difference in Least Squares Means|10.05|||<|0.001|TWO_SIDED|95.0|9.72|10.38|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.38|9.72|<0.001
73804932|NCT00529373|147159849|OTHER||Difference in Least Squares Means|1.1|||<|0.001|TWO_SIDED|95.0|0.66|1.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.54|0.66|<0.001
73804933|NCT00529373|147159849|OTHER||Difference in Least Squares Means|1.36|||<|0.001|TWO_SIDED|95.0|0.87|1.85|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.85|0.87|<0.001
73804934|NCT00529373|147159849|OTHER||Difference in Least Squares Means|1.96|||<|0.001|TWO_SIDED|95.0|1.42|2.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.50|1.42|<0.001
73804935|NCT00529373|147159849|OTHER||Difference in Least Squares Means|2.18|||<|0.001|TWO_SIDED|95.0|1.4|2.96|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.96|1.40|<0.001
73804936|NCT00529373|147159849|OTHER||Difference in Least Squares Means|2.33||||0.001|TWO_SIDED|95.0|1.54|3.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.11|1.54|0.001
73895496|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|11.7||||0.035|TWO_SIDED|95.0|4.69|18.72|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 44||18.72|4.69|0.035
73804937|NCT00529373|147159850|OTHER||Hazard Ratio (HR)|0.33|||<|0.001|TWO_SIDED|95.0|0.24|0.45|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. the Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.45|0.24|<0.001
73804938|NCT00529373|147159851|OTHER||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.6|0.75|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.75|0.60|<0.001
73804939|NCT00529373|147159852|OTHER||Difference in Least Squares Means|1.34|||<|0.001|TWO_SIDED|95.0|0.94|1.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.74|0.94|<0.001
73804940|NCT00529373|147159852|OTHER||Difference in Least Squares Means|2.5|||<|0.001|TWO_SIDED|95.0|2.38|2.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.62|2.38|<0.001
73895497|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|10.6||||0.03|TWO_SIDED|95.0|4.2|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 44||17.06|4.20|0.030
73804941|NCT00529373|147159852|OTHER||Difference in Least Squares Means|4.47|||<|0.001|TWO_SIDED|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.62|4.31|<0.001
73804942|NCT00529373|147159852|OTHER||Difference in Least Squares Means|6.46|||<|0.001|TWO_SIDED|95.0|6.26|6.65|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.65|6.26|<0.001
73804943|NCT00529373|147159852|OTHER||Difference in Least Squares Means|8.48|||<|0.001|TWO_SIDED|95.0|8.24|8.73|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.73|8.24|<0.001
73804944|NCT00529373|147159852|OTHER||Difference in Least Squares Means|10.29|||<|0.001|TWO_SIDED|95.0|9.99|10.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.59|9.99|<0.001
73804945|NCT00529373|147159853|OTHER||Difference in Least Squares Means|1.74|||<|0.001|TWO_SIDED|95.0|1.06|2.42|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.42|1.06|<0.001
73804946|NCT00529373|147159853|OTHER||Difference in Least Squares Means|3.5|||<|0.001|TWO_SIDED|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.70|3.31|<0.001
73804947|NCT00529373|147159853|OTHER||Difference in Least Squares Means|6.41|||<|0.001|TWO_SIDED|95.0|6.16|6.65|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 24||6.65|6.16|<0.001
73804948|NCT00529373|147159853|OTHER||Difference in Least Squares Means|9.25|||<|0.001|TWO_SIDED|95.0|8.95|9.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.54|8.95|<0.001
73804949|NCT00529373|147159853|OTHER||Difference in Least Squares Means|12.14|||<|0.001|TWO_SIDED|95.0|11.76|12.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||12.51|11.76|<0.001
73804950|NCT00529373|147159853|OTHER||Difference in Least Squares Means|14.56|||<|0.001|TWO_SIDED|95.0|14.11|15.01|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||15.01|14.11|<0.001
73804951|NCT00529373|147159854|OTHER||Difference in Least Squares Means|2.9|||<|0.001|TWO_SIDED|95.0|2.4|3.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.39|2.40|<0.001
73804952|NCT00529373|147159854|OTHER||Difference in Least Squares Means|4.01|||<|0.001|TWO_SIDED|95.0|3.87|4.15|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.15|3.87|<0.001
73804953|NCT00529373|147159854|OTHER||Difference in Least Squares Means|5.93|||<|0.001|TWO_SIDED|95.0|5.75|6.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.11|5.75|<0.001
73804954|NCT00529373|147159854|OTHER||Difference in Least Squares Means|7.7|||<|0.001|TWO_SIDED|95.0|7.48|7.91|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||7.91|7.48|<0.001
73804955|NCT00529373|147159854|OTHER||Difference in Least Squares Means|9.34|||<|0.001|TWO_SIDED|95.0|9.08|9.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.61|9.08|<0.001
73804956|NCT00529373|147159854|OTHER||Difference in Least Squares Means|10.87|||<|0.001|TWO_SIDED|95.0|10.55|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.19|10.55|<0.001
73804957|NCT00529373|147159863|OTHER||Difference in Least Squares Means|2.76|||<|0.001|TWO_SIDED|95.0|1.43|4.1|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.10|1.43|<0.001
73804958|NCT00529373|147159864|OTHER||Difference in Least Squares Means|5.55|||<|0.001|TWO_SIDED|95.0|4.06|7.05|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||7.05|4.06|<0.001
73804959|NCT00529373|147159865|OTHER||Difference in Least Squares Means|2.79||||0.005|TWO_SIDED|95.0|0.86|4.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.72|0.86|0.005
73804960|NCT00529373|147159866|OTHER||Difference in Least Squares Means|3.63|||<|0.001|TWO_SIDED|95.0|2.35|4.9|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.90|2.35|<0.001
73804961|NCT00529373|147159867|OTHER||Difference in Least Squares Means|5.65|||<|0.001|TWO_SIDED|95.0|3.79|7.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||7.50|3.79|<0.001
73804962|NCT00529373|147159868|OTHER||Difference in Least Squares Means|-62.25|||<|0.001|TWO_SIDED|95.0|-79.99|-44.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-44.50|-79.99|<0.001
73804963|NCT00529373|147159869|OTHER||Difference in Least Squares Means|-26.7||||0.001|TWO_SIDED|95.0|-42.56|-10.83|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-10.83|-42.56|0.001
73804964|NCT00529373|147159870|OTHER||Difference in Least Squares Means|1.67||||0.016|TWO_SIDED|95.0|0.32|3.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||3.01|0.32|0.016
73804965|NCT00529373|147159871|OTHER||Difference in Least Squares Means|-25.02|||<|0.001|TWO_SIDED|95.0|-35.92|-14.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-14.12|-35.92|<0.001
73804966|NCT00529373|147159872|OTHER||Difference in Least Squares Means|-64.43|||<|0.001|TWO_SIDED|95.0|-87.8|-41.07|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-41.07|-87.80|<0.001
73804967|NCT00529373|147159873|OTHER||Difference in Least Squares Means|8.53|||<|0.001|TWO_SIDED|95.0|5.79|11.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||11.28|5.79|<0.001
73804968|NCT00529373|147159874|OTHER||Difference in Least Squares Means|11.08|||<|0.001|TWO_SIDED|95.0|8.41|13.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||13.74|8.41|<0.001
73804969|NCT00529373|147159875|OTHER||Difference in Least Squares Means|10.41|||<|0.001|TWO_SIDED|95.0|8.05|12.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||12.78|8.05|<0.001
73804970|NCT00529373|147159876|OTHER||Difference in Least Squares Means|9.98|||<|0.001|TWO_SIDED|95.0|6.91|13.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||13.06|6.91|<0.001
73804971|NCT00529373|147159877|OTHER||Difference in Least Squares Means|14.94|||<|0.001|TWO_SIDED|95.0|11.29|18.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||18.59|11.29|<0.001
73804972|NCT00529373|147159878|OTHER||Hazard Ratio (HR)|0.79||||0.366|TWO_SIDED|95.0|0.47|1.33|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.33|0.47|0.366
73804973|NCT00529373|147159879|OTHER||Hazard Ratio (HR)|1.13||||0.246|TWO_SIDED|95.0|0.92|1.4|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.4|0.92|0.246
73804974|NCT00529373|147159880|OTHER||Hazard Ratio (HR)|0.8||||0.638|TWO_SIDED|95.0|0.32|2.03|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.03|0.32|0.638
73804975|NCT00529373|147159881|OTHER||Hazard Ratio (HR)|1.17||||0.029|TWO_SIDED|95.0|1.02|1.36|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.36|1.02|0.029
73804976|NCT00529373|147159882|OTHER||Hazard Ratio (HR)|1.05||||0.341|TWO_SIDED|95.0|0.95|1.17|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.17|0.95|0.341
73804977|NCT00529373|147159883|OTHER||Hazard Ratio (HR)|1.23||||0.198|TWO_SIDED|95.0|0.9|1.68|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.68|0.9|0.198
73804978|NCT00529373|147159884|OTHER||Hazard Ratio (HR)|0.94||||0.798|TWO_SIDED|95.0|0.7|1.26|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.26|0.7|0.798
73895498|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|11.1||||0.048|TWO_SIDED|95.0|4.15|18.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 52||18.06|4.15|0.048
73804979|NCT00529373|147159885|OTHER||Hazard Ratio (HR)|1.37||||0.005|TWO_SIDED|95.0|1.1|1.71|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.71|1.1|0.005
73804980|NCT00529373|147159886|OTHER||Hazard Ratio (HR)|1.22||||0.059|TWO_SIDED|95.0|0.99|1.5|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.5|0.99|0.059
73804981|NCT00529373|147159887|OTHER||Hazard Ratio (HR)|1.61||||0.114|TWO_SIDED|95.0|0.89|2.9|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.9|0.89|0.114
73804982|NCT00529373|147159888|OTHER||Hazard Ratio (HR)|1.14||||0.159|TWO_SIDED|95.0|0.99|1.31|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.31|0.99|0.159
73804983|NCT00529373|147159889|OTHER||Hazard Ratio (HR)|1.17||||0.178|TWO_SIDED|95.0|0.93|1.46|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.46|0.93|0.178
73804984|NCT00529373|147159890|OTHER|Miettinen \& Nurminen|Difference in rates|0.04|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
73804985|NCT00529373|147159891|OTHER|Miettinen \& Nurminen|Difference in rates|0.02|||||TWO_SIDED|95.0|0.01|0.05||||||||0.05|0.01|
73804986|NCT00529373|147159892|OTHER|Miettinen \& Nurminen|Difference in rates|0.06|||||TWO_SIDED|95.0|0.03|0.11||||||||0.11|0.03|
73804987|NCT00529373|147159893|OTHER|Miettinen \& Nurminen|Difference in rates|0.03|||||TWO_SIDED|95.0|0.02|0.06||||||||0.06|0.02|
73804988|NCT02915705|147159926|SUPERIORITY||LS Mean Difference|1.14|||<|0.0001|TWO_SIDED|95.0|0.83|1.45|||ANCOVA|||Least squares (LS) mean, standard error (SE), confidence interval (CI), and 2-sided p value per ANCOVA model, which included RGI-C as the dependent variable, treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.||1.45|0.83|< 0.0001
73804989|NCT02915705|147159927|SUPERIORITY||Odds Ratio (OR)|39.1|||<|0.0001|TWO_SIDED|95.0|7.2|211.7||Odds ratio, CI, and 2-sided p-value were per logistic regression model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|Regression, Logistic|||||211.7|7.2|< 0.0001
73804990|NCT02915705|147159928|SUPERIORITY||Odds Ratio (OR)|34.1||||0.0002|TWO_SIDED|95.0|5.6|206.3||Odds ratio, CI, and 2-sided p-value were per generalized linear mixed model, which includes treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS total score as a continuous covariate.|generalized linear mixed model|||||206.3|5.6|0.0002
73895499|NCT01578850|147324496|SUPERIORITY_OR_OTHER||Difference in proportions|11.2||||0.016|TWO_SIDED|95.0|4.92|17.58|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 52||17.58|4.92|0.016
73804991|NCT02915705|147159929|SUPERIORITY||difference in LS means|1.02|||<|0.0001|TWO_SIDED|95.0|0.72|1.33|||GEE model|||Per generalized estimating equation (GEE) model, which included RGI-C as the dependent variable, treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate, with exchangeable covariate structure.||1.33|0.72|< 0.0001
73804992|NCT02915705|147159930|SUPERIORITY||LS Mean Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.74|-0.94||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|ANCOVA|||||-0.94|-1.74|< 0.0001
73804993|NCT02915705|147159931|SUPERIORITY||difference in LS means|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.83||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate.|GEE model|||||-0.83|-1.59|< 0.0001
73804994|NCT02915705|147159932|SUPERIORITY||LS Mean Difference|0.4||||0.0162|TWO_SIDED|95.0|0.07|0.72||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model|||||0.72|0.07|0.0162
73804995|NCT02915705|147159933|SUPERIORITY||difference in LS means|0.97|||<|0.0001|TWO_SIDED|95.0|0.57|1.37||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model|||||1.37|0.57|< 0.0001
73804996|NCT02915705|147159934|SUPERIORITY||LS Mean Difference|0.12||||0.0408|TWO_SIDED|95.0|0.01|0.24|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.||0.24|0.01|0.0408
73804997|NCT02915705|147159935|SUPERIORITY||difference in LS means|0.14||||0.049|TWO_SIDED|95.0|0.0|0.29|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.||0.29|0.00|0.0490
73804998|NCT02915705|147159936|SUPERIORITY||difference in LS means|1.02||||0.0386|TWO_SIDED|95.0|0.06|1.99|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.||1.99|0.06|0.0386
73804999|NCT02915705|147159937|SUPERIORITY||difference in LS means|1.12||||0.0047|TWO_SIDED|95.0|0.37|1.88|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.||1.88|0.37|0.0047
73805000|NCT02915705|147159938|SUPERIORITY||difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.81|1.27|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 1||1.27|0.81|< 0.0001
73805001|NCT02915705|147159938|SUPERIORITY||difference|1.03|||<|0.0001|TWO_SIDED|95.0|0.79|1.27|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||1.27|0.79|< 0.0001
73895500|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA Baseline||1.81|-0.59|0.358
73805002|NCT02915705|147159938|SUPERIORITY||difference|0.78|||<|0.0001|TWO_SIDED|95.0|0.58|0.97|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||0.97|0.58|< 0.0001
73805003|NCT02915705|147159938|SUPERIORITY||difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.44|0.81|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||0.81|0.44|< 0.0001
73805004|NCT02915705|147159938|SUPERIORITY||difference|0.51|||<|0.0001|TWO_SIDED|95.0|0.3|0.72|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||0.72|0.30|< 0.0001
73805005|NCT02915705|147159938|SUPERIORITY||difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.51|0.89|||GEE model|||Week 32||0.89|0.51|< 0.0001
73805006|NCT02915705|147159938|SUPERIORITY||difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.51|0.91|||GEE model||Difference (burosumab - Oral Phosphate/Active Vitamin D)|Week 40||0.91|0.51|< 0.0001
73805007|NCT02915705|147159938|SUPERIORITY||difference|0.61|||<|0.0001|TWO_SIDED|95.0|0.39|0.82|||GEE model|||Week 52||0.82|0.39|< 0.0001
73805008|NCT02915705|147159938|SUPERIORITY||difference|0.69|||<|0.0001|TWO_SIDED|95.0|0.49|0.9|||GEE model|||Week 64||0.90|0.49|< 0.0001
73805009|NCT02915705|147159940|SUPERIORITY||difference in LS means|0.74|||<|0.0001|TWO_SIDED|95.0|0.58|0.91|||ANCOVA||Difference (KRN23 - Oral Phosphate/Active Vitamin D)|||0.91|0.58|< 0.0001
73805010|NCT02915705|147159943|SUPERIORITY||difference|48.27|||<|0.0001|TWO_SIDED|95.0|36.53|60.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 1||60.02|36.53|< 0.0001
73805011|NCT02915705|147159943|SUPERIORITY||difference|21.09|||<|0.0001|TWO_SIDED|95.0|12.01|30.16|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||30.16|12.01|< 0.0001
73805012|NCT02915705|147159943|SUPERIORITY||difference|15.75||||0.001|TWO_SIDED|95.0|6.35|25.15|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||25.15|6.35|0.0010
73805013|NCT02915705|147159943|SUPERIORITY||difference|12.97||||0.0078|TWO_SIDED|95.0|3.41|22.53|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||22.53|3.41|0.0078
73805014|NCT02915705|147159943|SUPERIORITY||difference|10.89||||0.0101|TWO_SIDED|95.0|2.59|19.19|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||19.19|2.59|0.0101
73805015|NCT02915705|147159943|SUPERIORITY||difference|6.23||||0.1165|TWO_SIDED|95.0|-1.55|14.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 32||14.02|-1.55|0.1165
73805016|NCT02915705|147159943|SUPERIORITY||difference|11.21||||0.0317|TWO_SIDED|95.0|0.98|21.44|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||21.44|0.98|0.0317
73805017|NCT02915705|147159943|SUPERIORITY||difference|5.01||||0.3044|TWO_SIDED|95.0|-4.55|14.56|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||14.56|-4.55|0.3044
73805018|NCT02915705|147159943|SUPERIORITY||difference|8.7||||0.0145|TWO_SIDED|95.0|1.72|15.68|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D|Week 64||15.68|1.72|0.0145
73805019|NCT02915705|147159945|SUPERIORITY||difference|1.65|||<|0.0001|TWO_SIDED|95.0|1.28|2.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||2.02|1.28|< 0.0001
73805020|NCT02915705|147159945|SUPERIORITY||difference|1.42|||<|0.0001|TWO_SIDED|95.0|1.19|1.64|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||1.64|1.19|< 0.0001
73805021|NCT02915705|147159945|SUPERIORITY||difference|1.16|||<|0.0001|TWO_SIDED|95.0|0.84|1.48|||GEE model|||Week 16||1.48|0.84|< 0.0001
73805022|NCT02915705|147159945|SUPERIORITY||difference|1.11|||<|0.0001|TWO_SIDED|95.0|0.8|1.41|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||1.41|0.80|< 0.0001
73805023|NCT02915705|147159945|SUPERIORITY||difference|1.24|||<|0.0001|TWO_SIDED|95.0|0.98|1.51|||GEE model|||Week 32||1.51|0.98|< 0.0001
73805024|NCT02915705|147159945|SUPERIORITY||difference|1.35|||<|0.0001|TWO_SIDED|95.0|1.1|1.6|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||1.60|1.10|< 0.0001
73805025|NCT02915705|147159945|SUPERIORITY||difference|1.26|||<|0.0001|TWO_SIDED|95.0|0.97|1.54|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||1.54|0.97|< 0.0001
73805026|NCT02915705|147159945|SUPERIORITY||difference|1.25|||<|0.0001|TWO_SIDED|95.0|0.96|1.54|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 64||1.54|0.96|< 0.0001
73805027|NCT02915705|147159947|SUPERIORITY||difference|-92.53|||<|0.0001|TWO_SIDED|95.0|-131.4|-53.66|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||-53.66|-131.40|< 0.0001
73805028|NCT02915705|147159947|SUPERIORITY||difference|-85.57|||<|0.0001|TWO_SIDED|95.0|-126.37|-44.76|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||-44.76|-126.37|< 0.0001
73805029|NCT02915705|147159947|SUPERIORITY||difference|-95.95|||<|0.0001|TWO_SIDED|95.0|-136.05|-55.84|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||-55.84|-136.05|< 0.0001
73805030|NCT02915705|147159947|SUPERIORITY||difference|-111.28|||<|0.0001|TWO_SIDED|95.0|-152.08|-70.49|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||-70.49|-152.08|< 0.0001
73805031|NCT02915705|147159947|SUPERIORITY||difference|-146.56|||<|0.0001|TWO_SIDED|95.0|-191.61|-101.52|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 64||-101.52|-191.61|< 0.0001
73805032|NCT02915705|147159950|SUPERIORITY||difference in LS means|-5.02||||0.0212|TWO_SIDED|95.0|-9.29|-0.75|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||-0.75|-9.29|0.0212
73805033|NCT02915705|147159950|SUPERIORITY||difference in LS means|2.68||||0.1009|TWO_SIDED|95.0|-0.52|5.89|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||5.89|-0.52|0.1009
73805034|NCT02915705|147159950|SUPERIORITY||difference in LS means|-3.25||||0.1676|TWO_SIDED|95.0|-7.86|1.37|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||1.37|-7.86|0.1676
73805035|NCT02915705|147159951|SUPERIORITY||difference in LS means|-2.26||||0.3091|TWO_SIDED|95.0|-6.61|2.09|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||2.09|-6.61|0.3091
73805036|NCT02915705|147159951|SUPERIORITY||difference in LS means|1.9||||0.3145|TWO_SIDED|95.0|-1.8|5.59|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||5.59|-1.80|0.3145
73805037|NCT02915705|147159951|SUPERIORITY||difference in LS means|-1.08||||0.681|TWO_SIDED|95.0|-6.21|4.06|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||4.06|-6.21|0.6810
73805038|NCT02915705|147159952|SUPERIORITY||Difference in LS Means|0.01||||0.9862|TWO_SIDED|95.0|-0.79|0.8|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.||0.80|-0.79|0.9862
73805039|NCT02915705|147159953|SUPERIORITY||difference in LS means|0.05||||0.8786|TWO_SIDED|95.0|-0.58|0.68|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.||0.68|-0.58|0.8786
73805040|NCT02915705|147159954|SUPERIORITY||difference in LS means|43.46||||0.0514|TWO_SIDED|95.0|-0.26|87.17|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||87.17|-0.26|0.0514
73805041|NCT02915705|147159955|SUPERIORITY||difference in LS means|45.55||||0.0399|TWO_SIDED|95.0|2.09|89.02|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||89.02|2.09|0.0399
73805042|NCT02915705|147159956|SUPERIORITY||difference in LS means|6.72||||0.0633|TWO_SIDED|95.0|-0.37|13.82|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||13.82|-0.37|0.0633
73805043|NCT02915705|147159957|SUPERIORITY||difference in LS means|7.27||||0.0496|TWO_SIDED|95.0|0.01|14.52|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||14.52|0.01|0.0496
73805044|NCT00150488|147159960|OTHER|Compared to baseline|||||<|0.001|||||||Chi-squared|||||||<0.001
73805045|NCT03291431|147159963|OTHER|Chi-Square comparison of frequencies|Pearson Chi-Square|0.17||||0.99|TWO_SIDED|||||A p-value of \<0.05 is considered statistically significant.|Chi-squared|||||||0.99
73805046|NCT03291431|147159964|OTHER||Slope|-0.2||||0.68|TWO_SIDED|95.0||||p \< .05 considered statistically significant.|Mixed Models Analysis||Rate of change compared between groups using linear mixed modeling.|Linear mixed modeling||||0.68
73805047|NCT03291431|147159965|OTHER|||||||0.34||||||p-value \< .05 considered statistically significant.|Mixed Models Analysis|||||||0.34
73805048|NCT03291431|147159966|OTHER|Linear mixed modeling|Slope|-1.99||||0.7|TWO_SIDED|||||p \< .05 considered statistically significant.|Mixed Models Analysis||Rate of change compared between groups using linear mixed modeling.|||||0.70
73805049|NCT03291431|147159967|OTHER||Slope|0.3||||0.11|TWO_SIDED|||||p \< .05 considered statistically significant.|Mixed Models Analysis|||Linear mixed modeling||||0.11
73805050|NCT03850483|147159984|SUPERIORITY||Least square (LS) mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.1641|TWO_SIDED|90.0|-1.71|0.43||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.43|-1.71|0.1641
73805051|NCT03850483|147159984|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.65||0.61|TWO_SIDED|90.0|-0.89|1.26||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||1.26|-0.89|0.6100
73805052|NCT03850483|147159984|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.1686|TWO_SIDED|90.0|-1.7|0.45||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.45|-1.70|0.1686
73805053|NCT03850483|147159984|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.64||0.1051|TWO_SIDED|90.0|-1.87|0.25||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.25|-1.87|0.1051
73805054|NCT03850483|147159984|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.68||0.3583|TWO_SIDED|90.0|-1.37|0.88||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.88|-1.37|0.3583
73805055|NCT03850483|147159984|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.1131|TWO_SIDED|90.0|-1.88|0.29||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.29|-1.88|0.1131
73805056|NCT03850483|147159984|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.64||0.1812|TWO_SIDED|90.0|-1.64|0.47||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.47|-1.64|0.1812
73805057|NCT03850483|147159985|SUPERIORITY||Risk Difference (RD)|3.4||||0.3747|TWO_SIDED|90.0|-10.6|17.9|||Chan and Zhang method|||||17.9|-10.6|0.3747
73805058|NCT03850483|147159985|SUPERIORITY||Risk Difference (RD)|8.5||||0.243|TWO_SIDED|90.0|-6.6|25.9|||Chan and Zhang method|||||25.9|-6.6|0.2430
73805059|NCT03850483|147159985|SUPERIORITY||Risk Difference (RD)|3.4||||0.3747|TWO_SIDED|90.0|-10.6|17.9|||Chan and Zhang method|||||17.9|-10.6|0.3747
73805060|NCT03850483|147159985|SUPERIORITY||Risk Difference (RD)|14.5||||0.0665|TWO_SIDED|0.0665|-1.3|31.5|||Chan and Zhang method|||||31.5|-1.3|0.0665
73805061|NCT03850483|147159985|SUPERIORITY||Risk Difference (RD)|6.1||||0.3423|TWO_SIDED|90.0|-12.1|25.5|||Chan and Zhang method|||||25.5|-12.1|0.3423
73805062|NCT03850483|147159985|SUPERIORITY||Risk Difference (RD)|12.9||||0.1271|TWO_SIDED|90.0|-4.7|30.9|||Chan and Zhang method|||||30.9|-4.7|0.1271
73805063|NCT03850483|147159985|SUPERIORITY||Risk Difference (RD)|3.2||||0.401|TWO_SIDED|90.0|-13.2|21.1|||Chan and Zhang method|||||21.1|-13.2|0.4010
73805064|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4225|TWO_SIDED|90.0|-11.2|10.4|||Chan and Zhang method|||Week 1||10.4|-11.2|0.4225
73805065|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 1||5.0|-14.0|0.7483
73805066|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 1||4.8|-14.0|0.7539
73805067|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 1||4.8|-14.0|0.7539
73805068|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-6.4|8.9|||Chan and Zhang method|||Week 1||8.9|-6.4|0.5000
73805069|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|2.9||||0.2125|TWO_SIDED|90.0|-3.4|13.2|||Chan and Zhang method|||Week 1||13.2|-3.4|0.2125
73805070|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|2.7||||0.2267|TWO_SIDED|90.0|-3.5|12.2|||Chan and Zhang method|||Week 1||12.2|-3.5|0.2267
73805071|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7592|TWO_SIDED|90.0|-14.0|4.6|||Chan and Zhang method|||Week 2||4.6|-14.0|0.7592
73805072|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7299|TWO_SIDED|90.0|-14.0|5.5|||Chan and Zhang method|||Week 2||5.5|-14.0|0.7299
73805073|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-0.3||||0.4463|TWO_SIDED|90.0|-11.3|9.4|||Chan and Zhang method|||Week 2||9.4|-11.3|0.4463
73805074|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 2||4.8|-14.0|0.7539
73805075|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-2.2||||0.7009|TWO_SIDED|90.0|-10.1|5.9|||Chan and Zhang method|||Week 2||5.9|-10.1|0.7009
73805076|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|4.0||||0.2507|TWO_SIDED|90.0|-4.5|15.6|||Chan and Zhang method|||Week 2||15.6|-4.5|0.2507
73805077|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|3.5||||0.2993|TWO_SIDED|90.0|-4.8|14.3|||Chan and Zhang method|||Week 2||14.3|-4.8|0.2993
73805078|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7363|TWO_SIDED|90.0|-14.0|5.5|||Chan and Zhang method|||Week 4||5.5|-14.0|0.7363
73805079|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|0.4||||0.5369|TWO_SIDED|90.0|-10.5|12.3|||Chan and Zhang method|||Week 4||12.3|-10.5|0.5369
73805080|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 4||5.0|-14.0|0.7483
73805081|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 4||5.0|-14.0|0.7483
73805082|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-2.2||||0.599|TWO_SIDED|90.0|-13.7|11.6|||Chan and Zhang method|||Week 4||11.6|-13.7|0.5990
73805083|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-5.9||||0.7926|TWO_SIDED|90.0|-16.4|4.9|||Chan and Zhang method|||Week 4||4.9|-16.4|0.7926
73805084|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|3.2||||0.3402|TWO_SIDED|90.0|-9.0|17.6|||Chan and Zhang method|||Week 4||17.6|-9.0|0.3402
73805085|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.2||||0.7364|TWO_SIDED|90.0|-14.4|5.7|||Chan and Zhang method|||Week 6||5.7|-14.4|0.7364
73805086|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|4.2||||0.3009|TWO_SIDED|90.0|-7.4|17.7|||Chan and Zhang method|||Week 6||17.7|-7.4|0.3009
73805087|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|3.2||||0.34|TWO_SIDED|90.0|-8.1|15.9|||Chan and Zhang method|||Week 6||15.9|-8.1|0.3400
73805088|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|7.1||||0.1631|TWO_SIDED|90.0|-4.8|21.1|||Chan and Zhang method|||Week 6||21.1|-4.8|0.1631
73805089|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6214|TWO_SIDED|90.0|-17.8|13.0|||Chan and Zhang method|||Week 6||13.0|-17.8|0.6214
73805090|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6214|TWO_SIDED|90.0|-17.8|13.0|||Chan and Zhang method|||Week 6||13.0|-17.8|0.6214
73805091|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.5||||0.6413|TWO_SIDED|90.0|-17.9|11.7|||Chan and Zhang method|||Week 6||11.7|-17.9|0.6413
73805092|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-13.1|13.1|||Chan and Zhang method|||Week 8||13.1|-13.1|0.5000
73805093|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|0.7||||0.5134|TWO_SIDED|90.0|-12.6|15.2|||Chan and Zhang method|||Week 8||15.2|-12.6|0.5134
73805094|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4468|TWO_SIDED|90.0|-13.4|12.5|||Chan and Zhang method|||Week 8||12.5|-13.4|0.4468
73805095|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|7.6||||0.2778|TWO_SIDED|90.0|-6.8|23.9|||Chan and Zhang method|||Week 8||23.9|-6.8|0.2778
73805096|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|2.1||||0.4571|TWO_SIDED|90.0|-14.5|21.0|||Chan and Zhang method|||Week 8||21.0|-14.5|0.4571
73805097|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4741|TWO_SIDED|90.0|-15.3|16.7|||Chan and Zhang method|||Week 8||16.7|-15.3|0.4741
73805098|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|0.4||||0.5153|TWO_SIDED|90.0|-14.8|16.7|||Chan and Zhang method|||Week 8||16.7|-14.8|0.5153
73805099|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-7.0||||0.8287|TWO_SIDED|90.0|-21.1|5.3|||Chan and Zhang method|||Week 10||5.3|-21.1|0.8287
73805100|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-2.3||||0.5675|TWO_SIDED|90.0|-17.8|14.2|||Chan and Zhang method|||Week 10||14.2|-17.8|0.5675
73805101|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|6.9||||0.2648|TWO_SIDED|90.0|-9.8|23.2|||Chan and Zhang method|||Week 10||23.2|-9.8|0.2648
73805102|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|3.9||||0.3792|TWO_SIDED|90.0|-11.8|20.8|||Chan and Zhang method|||Week 10||20.8|-11.8|0.3792
73805103|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|2.7||||0.4438|TWO_SIDED|90.0|-16.3|23.1|||Chan and Zhang method|||Week 10||23.1|-16.3|0.4438
73805104|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-7.5||||0.7014|TWO_SIDED|90.0|-23.3|9.4|||Chan and Zhang method|||Week 10||9.4|-23.3|0.7014
73805105|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-2.8||||0.5841|TWO_SIDED|90.0|-19.7|15.0|||Chan and Zhang method|||Week 10||15.0|-19.7|0.5841
73805106|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-15.3|15.3|||Chan and Zhang method|||Week 12||15.3|-15.3|0.5000
73805107|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5834|TWO_SIDED|90.0|-17.5|12.3|||Chan and Zhang method|||Week 12||12.3|-17.5|0.5834
73805108|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|10.3||||0.1534|TWO_SIDED|90.0|-6.4|27.2|||Chan and Zhang method|||Week 12||27.2|-6.4|0.1534
73805109|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|7.5||||0.272|TWO_SIDED|90.0|-8.8|24.9|||Chan and Zhang method|||Week 12||24.9|-8.8|0.2720
73805110|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-8.1||||0.6815|TWO_SIDED|90.0|-25.1|10.4|||Chan and Zhang method|||Week 12||10.4|-25.1|0.6815
73805111|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|3.5||||0.39|TWO_SIDED|90.0|-14.4|22.0|||Chan and Zhang method|||Week 12||22.0|-14.4|0.3900
73805112|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5865|TWO_SIDED|90.0|-20.0|15.9|||Chan and Zhang method|||Week 12||15.9|-20.0|0.5865
73805113|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|4.2||||0.3087|TWO_SIDED|90.0|-8.2|18.9|||Chan and Zhang method|||Week 14||18.9|-8.2|0.3087
73805114|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|5.2||||0.3137|TWO_SIDED|90.0|-8.2|20.9|||Chan and Zhang method|||Week 14||20.9|-8.2|0.3137
73805115|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|18.0||||0.0245|TWO_SIDED|90.0|2.7|34.8|||Chan and Zhang method|||Week 14||34.8|2.7|0.0245
73805116|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|10.8||||0.1119|TWO_SIDED|90.0|-3.0|26.0|||Chan and Zhang method|||Week 14||26.0|-3.0|0.1119
73805117|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|2.7||||0.414|TWO_SIDED|90.0|-13.2|20.4|||Chan and Zhang method|||Week 14||20.4|-13.2|0.4140
73805118|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|9.7||||0.2356|TWO_SIDED|90.0|-7.2|28.5|||Chan and Zhang method|||Week 14||28.5|-7.2|0.2356
73805119|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|4.5||||0.3638|TWO_SIDED|90.0|-11.5|21.5|||Chan and Zhang method|||Week 14||21.5|-11.5|0.3638
73805120|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|7.7||||0.1613|TWO_SIDED|90.0|-5.2|22.9|||Chan and Zhang method|||Week 16||22.9|-5.2|0.1613
73805121|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|13.9||||0.0557|TWO_SIDED|90.0|-0.5|31.4|||Chan and Zhang method|||Week 16||31.4|-0.5|0.0557
73805122|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|21.6||||0.0114|TWO_SIDED|90.0|5.6|38.3|||Chan and Zhang method|||Week 16||38.3|5.6|0.0114
73805123|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|11.9||||0.0753|TWO_SIDED|90.0|-1.8|28.1|||Chan and Zhang method|||Week 16||28.1|-1.8|0.0753
73805124|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.1||||0.5635|TWO_SIDED|90.0|-20.1|15.2|||Chan and Zhang method|||Week 16||15.2|-20.1|0.5635
73805125|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-3.6||||0.6201|TWO_SIDED|90.0|-20.3|14.5|||Chan and Zhang method|||Week 16||14.5|-20.3|0.6201
73805126|NCT03850483|147159986|SUPERIORITY||Risk Difference (RD)|-0.7||||0.4792|TWO_SIDED|90.0|-17.6|17.0|||Chan and Zhang method|||Week 16||17.0|-17.6|0.4792
73805127|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.8038|TWO_SIDED|90.0|-0.25|0.79|||MMRM|||Week 1: Mixed-effect model with repeated measures (MMRM) analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.79|-0.25|0.8038
73805128|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.8267|TWO_SIDED|90.0|-0.22|0.81|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.81|-0.22|0.8267
73805129|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.6039|TWO_SIDED|90.0|-0.43|0.6|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.60|-0.43|0.6039
73805130|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.6339|TWO_SIDED|90.0|-0.41|0.62|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.62|-0.41|0.6339
73805131|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.2666|TWO_SIDED|90.0|-0.68|0.31|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.31|-0.68|0.2666
73805132|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.2257|TWO_SIDED|90.0|-0.7|0.26|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.26|-0.70|0.2257
73805133|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.1306|TWO_SIDED|90.0|-0.81|0.15|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-0.81|0.1306
73805134|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.37||0.9704|TWO_SIDED|90.0|0.09|1.31|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.31|0.09|0.9704
73805135|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.38||0.889|TWO_SIDED|90.0|-0.16|1.09|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.09|-0.16|0.8890
73805136|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.4506|TWO_SIDED|90.0|-0.66|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.66|0.4506
73805137|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.584|TWO_SIDED|90.0|-0.53|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.69|-0.53|0.5840
73805138|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.0769|TWO_SIDED|90.0|-1.17|0.08|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.08|-1.17|0.0769
73805139|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.38||0.0242|TWO_SIDED|90.0|-1.39|-0.13|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.13|-1.39|0.0242
73805140|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.38||0.0127|TWO_SIDED|90.0|-1.49|-0.23|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.23|-1.49|0.0127
73805141|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.44||0.6693|TWO_SIDED|90.0|-0.54|0.93|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.93|-0.54|0.6693
73805142|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6742|TWO_SIDED|90.0|-0.55|0.96|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.96|-0.55|0.6742
73805143|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.44||0.4486|TWO_SIDED|90.0|-0.79|0.67|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-0.79|0.4486
73805144|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3219|TWO_SIDED|90.0|-0.93|0.53|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-0.93|0.3219
73805145|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.55||0.0096|TWO_SIDED|90.0|-2.21|-0.39|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.39|-2.21|0.0096
73805146|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.54||0.0862|TWO_SIDED|90.0|-1.64|0.15|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-1.64|0.0862
73805147|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54||0.0111|TWO_SIDED|90.0|-2.15|-0.36|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.36|-2.15|0.0111
73805148|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.6107|TWO_SIDED|90.0|-0.68|0.97|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.97|-0.68|0.6107
73805149|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.51||0.724|TWO_SIDED|90.0|-0.54|1.15|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.15|-0.54|0.7240
73805150|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.43|TWO_SIDED|90.0|-0.91|0.74|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.74|-0.91|0.4300
73805151|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.0501|TWO_SIDED|90.0|-1.66|0.0|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.00|-1.66|0.0501
73805152|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.58||0.0157|TWO_SIDED|90.0|-2.23|-0.3|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.30|-2.23|0.0157
73805153|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.57||0.0645|TWO_SIDED|90.0|-1.83|0.07|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.83|0.0645
73805154|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.57||0.0621|TWO_SIDED|90.0|-1.84|0.06|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.06|-1.84|0.0621
73805155|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.55||0.2959|TWO_SIDED|90.0|-1.21|0.62|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.62|-1.21|0.2959
73805156|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.57||0.9043|TWO_SIDED|90.0|-0.19|1.69|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.69|-0.19|0.9043
73805157|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.55||0.2014|TWO_SIDED|90.0|-1.38|0.45|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.45|-1.38|0.2014
73805158|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.56||0.0948|TWO_SIDED|90.0|-1.66|0.19|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.19|-1.66|0.0948
73805159|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.65||0.0416|TWO_SIDED|90.0|-2.21|-0.06|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.06|-2.21|0.0416
73805160|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.64||0.0454|TWO_SIDED|90.0|-2.14|-0.03|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.03|-2.14|0.0454
73805161|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.64||0.0256|TWO_SIDED|90.0|-2.31|-0.2|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.20|-2.31|0.0256
73805162|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.2326|TWO_SIDED|90.0|-1.36|0.53|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-1.36|0.2326
73805163|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.59||0.5141|TWO_SIDED|90.0|-0.95|0.99|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.99|-0.95|0.5141
73805164|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.1124|TWO_SIDED|90.0|-1.64|0.25|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.25|-1.64|0.1124
73805165|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.0983|TWO_SIDED|90.0|-1.7|0.21|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.21|-1.70|0.0983
73805166|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.72||0.0412|TWO_SIDED|90.0|-2.46|-0.07|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.07|-2.46|0.0412
73805167|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.71||0.034|TWO_SIDED|90.0|-2.47|-0.13|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.13|-2.47|0.0340
73805168|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.71||0.0379|TWO_SIDED|90.0|-2.44|-0.09|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.09|-2.44|0.0379
73805169|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.68||0.1291|TWO_SIDED|90.0|-1.91|0.36|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.36|-1.91|0.1291
73805170|NCT03850483|147159987|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.5776|TWO_SIDED|90.0|-1.03|1.3|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.30|-1.03|0.5776
73805171|NCT03850483|147159987|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.69||0.1044|TWO_SIDED|90.0|-2.0|0.27|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.27|-2.00|0.1044
73805172|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69||0.0608|TWO_SIDED|90.0|-2.23|0.07|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-2.23|0.0608
73805173|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.8||0.0309|TWO_SIDED|90.0|-2.84|-0.18|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.18|-2.84|0.0309
73805174|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.78||0.0242|TWO_SIDED|90.0|-2.85|-0.26|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.26|-2.85|0.0242
73805175|NCT03850483|147159987|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.78||0.0394|TWO_SIDED|90.0|-2.69|-0.09|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.09|-2.69|0.0394
73805176|NCT03850483|147159989|SUPERIORITY||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|5.09||0.6917|TWO_SIDED|90.0|-5.86|10.97|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||10.97|-5.86|0.6917
73805177|NCT03850483|147159989|SUPERIORITY||LS mean difference|7.3|STANDARD_ERROR_OF_MEAN|5.07||0.9241|TWO_SIDED|90.0|-1.09|15.69|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||15.69|-1.09|0.9241
73805178|NCT03850483|147159989|SUPERIORITY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|5.03||0.8443|TWO_SIDED|90.0|-3.21|13.42|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||13.42|-3.21|0.8443
73805179|NCT03850483|147159989|SUPERIORITY||LS mean difference|2.5|STANDARD_ERROR_OF_MEAN|5.04||0.6911|TWO_SIDED|90.0|-5.82|10.86|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||10.86|-5.82|0.6911
73805180|NCT03850483|147159989|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|4.79||0.3676|TWO_SIDED|90.0|-9.56|6.31|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||6.31|-9.56|0.3676
73805181|NCT03850483|147159989|SUPERIORITY||LS mean difference|-6.3|STANDARD_ERROR_OF_MEAN|4.72||0.0915|TWO_SIDED|90.0|-14.13|1.5|||MMRM|||Week 1: Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.50|-14.13|0.0915
73805182|NCT03850483|147159989|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|4.72||0.097|TWO_SIDED|90.0|-13.96|1.65|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.65|-13.96|0.0970
73805183|NCT03850483|147159989|SUPERIORITY||LS mean difference|9.2|STANDARD_ERROR_OF_MEAN|5.91||0.9389|TWO_SIDED|90.0|-0.59|18.97|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||18.97|-0.59|0.9389
73805184|NCT03850483|147159989|SUPERIORITY||LS mean difference|9.0|STANDARD_ERROR_OF_MEAN|6.07||0.9295|TWO_SIDED|90.0|-1.06|19.02|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors||19.02|-1.06|0.9295
73805185|NCT03850483|147159989|SUPERIORITY||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|5.92||0.7308|TWO_SIDED|90.0|-6.15|13.45|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||13.45|-6.15|0.7308
73805186|NCT03850483|147159989|SUPERIORITY||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|5.94||0.6199|TWO_SIDED|90.0|-8.01|11.64|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||11.64|-8.01|0.6199
73805187|NCT03850483|147159989|SUPERIORITY||LS mean difference|-9.0|STANDARD_ERROR_OF_MEAN|6.09||0.0699|TWO_SIDED|90.0|-19.13|1.04|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.04|-19.13|0.0699
73805188|NCT03850483|147159989|SUPERIORITY||LS mean difference|-11.6|STANDARD_ERROR_OF_MEAN|6.14||0.03|TWO_SIDED|90.0|-21.79|-1.48|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.48|-21.79|0.0300
73805189|NCT03850483|147159989|SUPERIORITY||LS mean difference|-13.1|STANDARD_ERROR_OF_MEAN|6.09||0.0168|TWO_SIDED|90.0|-23.15|-2.98|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.98|-23.15|0.0168
73805190|NCT03850483|147159989|SUPERIORITY||LS mean difference|3.6|STANDARD_ERROR_OF_MEAN|6.61||0.7083|TWO_SIDED|90.0|-7.3|14.57|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.57|-7.30|0.7083
73805191|NCT03850483|147159989|SUPERIORITY||LS mean difference|8.5|STANDARD_ERROR_OF_MEAN|6.77||0.8955|TWO_SIDED|90.0|-2.66|19.75|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.75|-2.66|0.8955
73805192|NCT03850483|147159989|SUPERIORITY||LS mean difference|6.5|STANDARD_ERROR_OF_MEAN|6.56||0.8386|TWO_SIDED|90.0|-4.35|17.37|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||17.37|-4.35|0.8386
73805193|NCT03850483|147159989|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|6.58||0.4371|TWO_SIDED|90.0|-11.93|9.84|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||9.84|-11.93|0.4371
73805194|NCT03850483|147159989|SUPERIORITY||LS mean difference|-20.7|STANDARD_ERROR_OF_MEAN|8.91||0.0108|TWO_SIDED|90.0|-35.42|-5.92|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-5.92|-35.42|0.0108
73805195|NCT03850483|147159989|SUPERIORITY||LS mean difference|-10.9|STANDARD_ERROR_OF_MEAN|8.75||0.1066|TWO_SIDED|90.0|-25.43|3.55|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||3.55|-25.43|0.1066
73805196|NCT03850483|147159989|SUPERIORITY||LS mean difference|-16.0|STANDARD_ERROR_OF_MEAN|8.76||0.0344|TWO_SIDED|90.0|-30.54|-1.55|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.55|-30.54|0.0344
73805197|NCT03850483|147159989|SUPERIORITY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|8.29||0.6594|TWO_SIDED|90.0|-10.3|17.13|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||17.13|-10.30|0.6594
73805198|NCT03850483|147159989|SUPERIORITY||LS mean difference|5.3|STANDARD_ERROR_OF_MEAN|8.52||0.7307|TWO_SIDED|90.0|-8.85|19.36|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.36|-8.85|0.7307
73805199|NCT03850483|147159989|SUPERIORITY||LS mean difference|1.9|STANDARD_ERROR_OF_MEAN|8.28||0.5914|TWO_SIDED|90.0|-11.78|15.61|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||15.61|-11.78|0.5914
73805200|NCT03850483|147159989|SUPERIORITY||LS mean difference|-12.3|STANDARD_ERROR_OF_MEAN|8.34||0.0709|TWO_SIDED|90.0|-26.13|1.49|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.49|-26.13|0.0709
73805201|NCT03850483|147159989|SUPERIORITY||LS mean difference|-18.8|STANDARD_ERROR_OF_MEAN|9.53||0.0253|TWO_SIDED|90.0|-34.55|-3.01|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-3.01|-34.55|0.0253
73805202|NCT03850483|147159989|SUPERIORITY||LS mean difference|-13.4|STANDARD_ERROR_OF_MEAN|9.38||0.078|TWO_SIDED|90.0|-28.89|2.15|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||2.15|-28.89|0.0780
73805203|NCT03850483|147159989|SUPERIORITY||LS mean difference|-9.7|STANDARD_ERROR_OF_MEAN|9.36||0.1516|TWO_SIDED|90.0|-25.17|5.83|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||5.83|-25.17|0.1516
73805204|NCT03850483|147159989|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|9.14||0.4861|TWO_SIDED|90.0|-15.45|14.81|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.81|-15.45|0.4861
73805205|NCT03850483|147159989|SUPERIORITY||LS mean difference|11.0|STANDARD_ERROR_OF_MEAN|9.38||0.8795|TWO_SIDED|90.0|-4.48|26.55|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||26.55|-4.48|0.8795
73805206|NCT03850483|147159989|SUPERIORITY||LS mean difference|-5.1|STANDARD_ERROR_OF_MEAN|9.11||0.2867|TWO_SIDED|90.0|-20.22|9.94|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||9.94|-20.22|0.2867
73805207|NCT03850483|147159989|SUPERIORITY||LS mean difference|-10.6|STANDARD_ERROR_OF_MEAN|9.23||0.1267|TWO_SIDED|90.0|-25.86|4.69|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||4.69|-25.86|0.1267
73805208|NCT03850483|147159989|SUPERIORITY||LS mean difference|-17.1|STANDARD_ERROR_OF_MEAN|10.49||0.0526|TWO_SIDED|90.0|-34.48|0.26|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.26|-34.48|0.0526
73805209|NCT03850483|147159989|SUPERIORITY||LS mean difference|-14.3|STANDARD_ERROR_OF_MEAN|10.25||0.0827|TWO_SIDED|90.0|-31.26|2.68|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||2.68|-31.26|0.0827
73805210|NCT03850483|147159989|SUPERIORITY||LS mean difference|-16.1|STANDARD_ERROR_OF_MEAN|10.26||0.0592|TWO_SIDED|90.0|-33.12|0.86|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.86|-33.12|0.0592
73805211|NCT03850483|147159989|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|9.03||0.4657|TWO_SIDED|90.0|-15.72|14.16|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.16|-15.72|0.4657
73805212|NCT03850483|147159989|SUPERIORITY||LS mean difference|3.9|STANDARD_ERROR_OF_MEAN|9.3||0.6612|TWO_SIDED|90.0|-11.52|19.26|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.26|-11.52|0.6612
73805213|NCT03850483|147159989|SUPERIORITY||LS mean difference|-8.5|STANDARD_ERROR_OF_MEAN|9.03||0.1749|TWO_SIDED|90.0|-23.42|6.48|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||6.48|-23.42|0.1749
73805214|NCT03850483|147159989|SUPERIORITY||LS mean difference|-9.3|STANDARD_ERROR_OF_MEAN|9.12||0.1548|TWO_SIDED|90.0|-24.39|5.8|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||5.80|-24.39|0.1548
73805215|NCT03850483|147159989|SUPERIORITY||LS mean difference|-21.0|STANDARD_ERROR_OF_MEAN|11.89||0.04|TWO_SIDED|90.0|-40.67|-1.28|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.28|-40.67|0.0400
73805216|NCT03850483|147159989|SUPERIORITY||LS mean difference|-22.6|STANDARD_ERROR_OF_MEAN|11.6||0.0267|TWO_SIDED|90.0|-41.82|-3.39|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-3.39|-41.82|0.0267
73805217|NCT03850483|147159989|SUPERIORITY||LS mean difference|-22.2|STANDARD_ERROR_OF_MEAN|11.63||0.0295|TWO_SIDED|90.0|-41.42|-2.89|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.89|-41.42|0.0295
73805218|NCT03850483|147159989|SUPERIORITY||LS mean difference|-9.1|STANDARD_ERROR_OF_MEAN|10.38||0.1903|TWO_SIDED|90.0|-26.3|8.05|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||8.05|-26.30|0.1903
73805219|NCT03850483|147159989|SUPERIORITY||LS mean difference|1.4|STANDARD_ERROR_OF_MEAN|10.65||0.553|TWO_SIDED|90.0|-16.21|19.06|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.06|-16.21|0.5530
73805220|NCT03850483|147159989|SUPERIORITY||LS mean difference|-13.8|STANDARD_ERROR_OF_MEAN|10.37||0.0933|TWO_SIDED|90.0|-30.92|3.4|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||3.40|-30.92|0.0933
73805221|NCT03850483|147159989|SUPERIORITY||LS mean difference|-19.0|STANDARD_ERROR_OF_MEAN|10.49||0.036|TWO_SIDED|90.0|-36.37|-1.65|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.65|-36.37|0.0360
73805222|NCT03850483|147159989|SUPERIORITY||LS mean difference|-24.5|STANDARD_ERROR_OF_MEAN|13.46||0.0354|TWO_SIDED|90.0|-46.85|-2.23|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.23|-46.85|0.0354
73805223|NCT03850483|147159989|SUPERIORITY||LS mean difference|-26.1|STANDARD_ERROR_OF_MEAN|13.07||0.0239|TWO_SIDED|90.0|-47.77|-4.46|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-4.46|-47.77|0.0239
73805224|NCT03850483|147159989|SUPERIORITY||LS mean difference|-24.1|STANDARD_ERROR_OF_MEAN|13.11||0.0342|TWO_SIDED|90.0|-45.84|-2.38|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.38|-45.84|0.0342
73805225|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.3279|TWO_SIDED|90.0|-0.91|0.52|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-0.91|0.3279
73805226|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3566|TWO_SIDED|90.0|-0.88|0.56|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.88|0.3566
73805227|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.45||0.1165|TWO_SIDED|90.0|-1.29|0.21|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.29|0.1165
73805228|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3633|TWO_SIDED|90.0|-0.85|0.55|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.55|-0.85|0.3633
73805229|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.42||0.3766|TWO_SIDED|90.0|-0.83|0.56|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.83|0.3766
73805230|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.1179|TWO_SIDED|90.0|-1.22|0.2|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.20|-1.22|0.1179
73805231|NCT03850483|147159991|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.44||0.8647|TWO_SIDED|90.0|-0.24|1.2|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.20|-0.24|0.8647
73805232|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.3294|TWO_SIDED|90.0|-0.9|0.52|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-0.90|0.3294
73805233|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.44||0.1231|TWO_SIDED|90.0|-1.23|0.21|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.23|0.1231
73805234|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.0878|TWO_SIDED|90.0|-1.37|0.13|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.13|-1.37|0.0878
73805235|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.1225|TWO_SIDED|90.0|-1.2|0.21|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.20|0.1225
73805236|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3663|TWO_SIDED|90.0|-0.85|0.56|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.85|0.3663
73805237|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.43||0.0929|TWO_SIDED|90.0|-1.27|0.14|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.14|-1.27|0.0929
73805238|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3111|TWO_SIDED|90.0|-0.95|0.51|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.51|-0.95|0.3111
73805239|NCT03850483|147159991|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.4745|TWO_SIDED|90.0|-0.74|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.69|-0.74|0.4745
73805240|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.2409|TWO_SIDED|90.0|-1.03|0.42|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.42|-1.03|0.2409
73805241|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.2018|TWO_SIDED|90.0|-1.13|0.37|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.37|-1.13|0.2018
73805242|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3925|TWO_SIDED|90.0|-0.83|0.59|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.59|-0.83|0.3925
73805243|NCT03850483|147159991|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.42||0.5348|TWO_SIDED|90.0|-0.66|0.73|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.73|-0.66|0.5348
73805244|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.43||0.0739|TWO_SIDED|90.0|-1.33|0.09|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.09|-1.33|0.0739
73805245|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.44||0.4014|TWO_SIDED|90.0|-0.84|0.62|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.62|-0.84|0.4014
73805246|NCT03850483|147159991|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6588|TWO_SIDED|90.0|-0.56|0.93|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.93|-0.56|0.6588
73805247|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.2997|TWO_SIDED|90.0|-1.0|0.52|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-1.00|0.2997
73805248|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2518|TWO_SIDED|90.0|-1.08|0.46|||MMRM|||Week 4:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.46|-1.08|0.2518
73805249|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.2634|TWO_SIDED|90.0|-1.0|0.45|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.45|-1.00|0.2634
73805250|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.1999|TWO_SIDED|90.0|-1.11|0.36|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.36|-1.11|0.1999
73805251|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.44||0.1847|TWO_SIDED|90.0|-1.13|0.33|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.33|-1.13|0.1847
73805252|NCT03850483|147159991|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.4569|TWO_SIDED|90.0|-0.81|0.71|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.71|-0.81|0.4569
73805253|NCT03850483|147159991|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.45||0.8536|TWO_SIDED|90.0|-0.27|1.22|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.22|-0.27|0.8536
73805254|NCT03850483|147159991|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.4812|TWO_SIDED|90.0|-0.79|0.74|||MMRM|||Week 6:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.74|-0.79|0.4812
73805255|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.2276|TWO_SIDED|90.0|-1.13|0.42|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.42|-1.13|0.2276
73805256|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.0895|TWO_SIDED|90.0|-1.34|0.14|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.14|-1.34|0.0895
73805257|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.47||0.0411|TWO_SIDED|90.0|-1.58|-0.04|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.04|-1.58|0.0411
73805258|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.47||0.0928|TWO_SIDED|90.0|-1.4|0.15|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.15|-1.40|0.0928
73805259|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.49||0.0799|TWO_SIDED|90.0|-1.48|0.12|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.12|-1.48|0.0799
73805260|NCT03850483|147159991|SUPERIORITY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.46||0.7872|TWO_SIDED|90.0|-0.39|1.11|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.11|-0.39|0.7872
73805261|NCT03850483|147159991|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.6294|TWO_SIDED|90.0|-0.61|0.92|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.92|-0.61|0.6294
73805262|NCT03850483|147159991|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.48||0.5174|TWO_SIDED|90.0|-0.76|0.8|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.80|-0.76|0.5174
73805263|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.3136|TWO_SIDED|90.0|-0.98|0.53|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.53|-0.98|0.3136
73805264|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.102|TWO_SIDED|90.0|-1.42|0.18|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.18|-1.42|0.1020
73805265|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.1923|TWO_SIDED|90.0|-1.2|0.37|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.37|-1.20|0.1923
73805266|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.0997|TWO_SIDED|90.0|-1.44|0.18|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.18|-1.44|0.0997
73805267|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2497|TWO_SIDED|90.0|-1.08|0.45|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.45|-1.08|0.2497
73805268|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2568|TWO_SIDED|90.0|-1.08|0.47|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.47|-1.08|0.2568
73805269|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.48||0.373|TWO_SIDED|90.0|-0.95|0.64|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.64|-0.95|0.3730
73805270|NCT03850483|147159991|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.46||0.0137|TWO_SIDED|90.0|-1.76|-0.26|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.26|-1.76|0.0137
73805271|NCT03850483|147159991|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.49||0.0055|TWO_SIDED|90.0|-2.06|-0.44|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.44|-2.06|0.0055
73805272|NCT03850483|147159991|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.48||0.0069|TWO_SIDED|90.0|-1.99|-0.4|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.40|-1.99|0.0069
73805273|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.1648|TWO_SIDED|90.0|-1.34|0.34|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.34|-1.34|0.1648
73805274|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.2931|TWO_SIDED|90.0|-1.02|0.51|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.51|-1.02|0.2931
73805275|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.47||0.3047|TWO_SIDED|90.0|-1.01|0.53|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.53|-1.01|0.3047
73805276|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.48||0.1924|TWO_SIDED|90.0|-1.22|0.38|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.38|-1.22|0.1924
73805277|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.46||0.0465|TWO_SIDED|90.0|-1.52|-0.02|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.02|-1.52|0.0465
73805278|NCT03850483|147159991|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.49||0.0048|TWO_SIDED|90.0|-2.08|-0.47|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.47|-2.08|0.0048
73805279|NCT03850483|147159991|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.48||0.0186|TWO_SIDED|90.0|-1.78|-0.21|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.21|-1.78|0.0186
73805280|NCT03850483|147159991|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.51||0.0675|TWO_SIDED|90.0|-1.61|0.08|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.08|-1.61|0.0675
73805281|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.33||0.3232|TWO_SIDED|90.0|-0.69|0.39|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.39|-0.69|0.3232
73805282|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.33||0.0736|TWO_SIDED|90.0|-1.03|0.07|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.03|0.0736
73805283|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.0743|TWO_SIDED|90.0|-1.07|0.07|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.07|0.0743
73805284|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.32||0.0641|TWO_SIDED|90.0|-1.03|0.04|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.04|-1.03|0.0641
73805285|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.3887|TWO_SIDED|90.0|-0.71|0.5|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.50|-0.71|0.3887
73805286|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.37||0.0767|TWO_SIDED|90.0|-1.15|0.08|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.08|-1.15|0.0767
73805287|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.38||0.2529|TWO_SIDED|90.0|-0.89|0.38|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.38|-0.89|0.2529
73805288|NCT03850483|147159993|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.5304|TWO_SIDED|90.0|-0.61|0.67|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-0.61|0.5304
73805289|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.292|TWO_SIDED|90.0|-0.87|0.43|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.43|-0.87|0.2920
73805290|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41||0.2593|TWO_SIDED|90.0|-0.7|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.70|0.2593
73805291|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.38||0.431|TWO_SIDED|90.0|-0.7|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.70|0.4310
73805292|NCT03850483|147159993|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.5477|TWO_SIDED|90.0|-0.59|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.69|-0.59|0.5477
73805293|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.0696|TWO_SIDED|90.0|-1.24|0.07|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.24|0.0696
73805294|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41||0.3583|TWO_SIDED|90.0|-0.82|0.53|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-0.82|0.3583
73805295|NCT03850483|147159993|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.6826|TWO_SIDED|90.0|-0.56|1.01|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.01|-0.56|0.6826
73805296|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.48||0.457|TWO_SIDED|90.0|-0.84|0.74|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.74|-0.84|0.4570
73805297|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.3265|TWO_SIDED|90.0|-1.03|0.59|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.59|-1.03|0.3265
73805298|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.3039|TWO_SIDED|90.0|-1.0|0.53|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-1.00|0.3039
73805299|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.2086|TWO_SIDED|90.0|-1.23|0.42|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.42|-1.23|0.2086
73805300|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.2172|TWO_SIDED|90.0|-1.22|0.44|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.44|-1.22|0.2172
73805301|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.52||0.2855|TWO_SIDED|90.0|-1.16|0.57|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-1.16|0.2855
73805302|NCT03850483|147159993|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.8372|TWO_SIDED|90.0|-0.34|1.36|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.36|-0.34|0.8372
73805303|NCT03850483|147159993|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.52||0.4792|TWO_SIDED|90.0|-0.89|0.84|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.84|-0.89|0.4792
73805304|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.3331|TWO_SIDED|90.0|-1.12|0.65|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.65|-1.12|0.3331
73805305|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.108|TWO_SIDED|90.0|-1.47|0.21|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.21|-1.47|0.1080
73805306|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.48||0.0455|TWO_SIDED|90.0|-1.61|-0.02|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.02|-1.61|0.0455
73805307|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.48||0.0761|TWO_SIDED|90.0|-1.49|0.1|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.10|-1.49|0.0761
73805308|NCT03850483|147159993|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0273|TWO_SIDED|90.0|-1.8|-0.14|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.14|-1.80|0.0273
73805309|NCT03850483|147159993|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.54||0.7214|TWO_SIDED|90.0|-0.57|1.2|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.20|-0.57|0.7214
73805310|NCT03850483|147159993|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.55||0.6132|TWO_SIDED|90.0|-0.75|1.06|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.06|-0.75|0.6132
73805311|NCT03850483|147159993|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.5704|TWO_SIDED|90.0|-0.83|1.02|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.02|-0.83|0.5704
73805312|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.3449|TWO_SIDED|90.0|-1.1|0.67|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-1.10|0.3449
73805313|NCT03850483|147159993|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.58||0.0493|TWO_SIDED|90.0|-1.94|0.0|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.00|-1.94|0.0493
73805314|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.57||0.149|TWO_SIDED|90.0|-1.55|0.35|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.35|-1.55|0.1490
73805315|NCT03850483|147159993|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.054|TWO_SIDED|90.0|-1.96|0.02|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.02|-1.96|0.0540
73805316|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.61||0.3119|TWO_SIDED|90.0|-1.32|0.71|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.71|-1.32|0.3119
73805317|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.3947|TWO_SIDED|90.0|-1.2|0.86|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.86|-1.20|0.3947
73805318|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.64||0.4205|TWO_SIDED|90.0|-1.18|0.93|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.93|-1.18|0.4205
73805319|NCT03850483|147159993|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.0472|TWO_SIDED|90.0|-2.02|-0.02|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.02|-2.02|0.0472
73805320|NCT03850483|147159993|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.59||0.0044|TWO_SIDED|90.0|-2.55|-0.6|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.60|-2.55|0.0044
73805321|NCT03850483|147159993|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.0098|TWO_SIDED|90.0|-2.32|-0.41|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.41|-2.32|0.0098
73805322|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61||0.1285|TWO_SIDED|90.0|-1.71|0.32|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.32|-1.71|0.1285
73805323|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.6||0.3243|TWO_SIDED|90.0|-1.27|0.72|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.72|-1.27|0.3243
73805324|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.61||0.3795|TWO_SIDED|90.0|-1.2|0.82|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.82|-1.20|0.3795
73805325|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.62||0.307|TWO_SIDED|90.0|-1.35|0.72|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.72|-1.35|0.3070
73805326|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.59||0.1014|TWO_SIDED|90.0|-1.74|0.22|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.22|-1.74|0.1014
73805327|NCT03850483|147159993|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.62||0.0033|TWO_SIDED|90.0|-2.75|-0.69|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.69|-2.75|0.0033
73805328|NCT03850483|147159993|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.028|TWO_SIDED|90.0|-2.18|-0.17|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.17|-2.18|0.0280
73805329|NCT03850483|147159993|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.64||0.0781|TWO_SIDED|90.0|-1.98|0.15|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-1.98|0.0781
73805330|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 1||9.1|-9.4|0.4216
73805331|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 1||9.1|-9.4|0.4216
73805332|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7362|TWO_SIDED|90.0|-12.5|5.0|||Chan and Zhang method|||Week 1||5.0|-12.5|0.7362
73805333|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 1||4.7|-12.5|0.7417
73805334|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-5.9|8.0|||Chan and Zhang method|||Week 1||8.0|-5.9|0.5000
73805335|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|5.7||||0.0714|TWO_SIDED|90.0|-0.8|16.9|||Chan and Zhang method|||Week 1||16.9|-0.8|0.0714
73805336|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|5.3||||0.0813|TWO_SIDED|90.0|-1.1|15.7|||Chan and Zhang method|||Week 1||15.7|-1.1|0.0813
73805337|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 2||4.7|-12.5|0.7417
73805338|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 2||4.7|-12.5|0.7417
73805339|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-9.6|9.6|||Chan and Zhang method|||Week 2||9.6|-9.6|0.5000
73805340|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 2||9.1|-9.4|0.4216
73805341|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-2.0||||0.6894|TWO_SIDED|90.0|-9.4|5.9|||Chan and Zhang method|||Week 2||5.9|-9.4|0.6894
73805342|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|3.7||||0.2518|TWO_SIDED|90.0|-4.2|14.3|||Chan and Zhang method|||Week 2||14.3|-4.2|0.2518
73805343|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|8.5||||0.0565|TWO_SIDED|90.0|-0.3|20.3|||Chan and Zhang method|||Week 2||20.3|-0.3|0.0565
73805344|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4446|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.4446
73805345|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-5.6||||0.9001|TWO_SIDED|90.0|-16.5|1.9|||Chan and Zhang method|||Week 4||1.9|-16.5|0.9001
73805346|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.5000
73805347|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4446|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.4446
73805348|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|0.2||||0.5054|TWO_SIDED|90.0|-10.5|12.5|||Chan and Zhang method|||Week 4||12.5|-10.5|0.5054
73805349|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|3.3||||0.3401|TWO_SIDED|90.0|-8.2|16.9|||Chan and Zhang method|||Week 4||16.9|-8.2|0.3401
73805350|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|12.9||||0.0489|TWO_SIDED|90.0|0.1|27.5|||Chan and Zhang method|||Week 4||27.5|0.1|0.0489
73805351|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-2.9||||0.6349|TWO_SIDED|90.0|-14.8|8.4|||Chan and Zhang method|||Week 6||8.4|-14.8|0.6349
73805352|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-5.6||||0.8253|TWO_SIDED|90.0|-17.2|4.4|||Chan and Zhang method|||Week 6||4.4|-17.2|0.8253
73805353|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-12.5|12.5|||Chan and Zhang method|||Week 6||12.5|-12.5|0.5000
73805354|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|5.2||||0.2709|TWO_SIDED|90.0|-8.3|19.1|||Chan and Zhang method|||Week 6||19.1|-8.3|0.2709
73805355|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|0.2||||0.5054|TWO_SIDED|90.0|-10.5|12.5|||Chan and Zhang method|||Week 6||12.5|-10.5|0.5054
73805356|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-2.4||||0.6319|TWO_SIDED|90.0|-12.9|9.3|||Chan and Zhang method|||Week 6||9.3|-12.9|0.6319
73805357|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|5.0||||0.3199|TWO_SIDED|90.0|-6.4|18.1|||Chan and Zhang method|||Week 6||18.1|-6.4|0.3199
73805358|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-5.7||||0.7306|TWO_SIDED|90.0|-19.1|6.1|||Chan and Zhang method|||Week 8||6.1|-19.1|0.7306
73805359|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-5.7||||0.7306|TWO_SIDED|90.0|-19.1|6.1|||Chan and Zhang method|||Week 8||6.1|-19.1|0.7306
73805360|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-8.3||||0.8808|TWO_SIDED|90.0|-20.6|2.7|||Chan and Zhang method|||Week 8||2.7|-20.6|0.8808
73805361|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-0.3||||0.4644|TWO_SIDED|90.0|-13.7|13.7|||Chan and Zhang method|||Week 8||13.7|-13.7|0.4644
73805362|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|7.8||||0.1534|TWO_SIDED|90.0|-3.4|20.9|||Chan and Zhang method|||Week 8||20.9|-3.4|0.1534
73805363|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-0.4||||0.4867|TWO_SIDED|90.0|-10.0|11.4|||Chan and Zhang method|||Week 8||11.4|-10.0|0.4867
73805364|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|12.3||||0.0435|TWO_SIDED|90.0|0.4|25.9|||Chan and Zhang method|||Week 8||25.9|0.4|0.0435
73805365|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-2.9||||0.6349|TWO_SIDED|90.0|-14.8|8.4|||Chan and Zhang method|||Week 10||8.4|-14.8|0.6349
73805366|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4565|TWO_SIDED|90.0|-12.6|12.5|||Chan and Zhang method|||Week 10||12.5|-12.6|0.4565
73805367|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-12.5|12.5|||Chan and Zhang method|||Week 10||12.5|-12.5|0.5000
73805368|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|7.9||||0.1765|TWO_SIDED|90.0|-5.7|21.8|||Chan and Zhang method|||Week 10||21.8|-5.7|0.1765
73805369|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|0.3||||0.5013|TWO_SIDED|90.0|-14.0|15.2|||Chan and Zhang method|||Week 10||15.2|-14.0|0.5013
73805370|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-7.8||||0.7969|TWO_SIDED|90.0|-20.7|5.9|||Chan and Zhang method|||Week 10||5.9|-20.7|0.7969
73805371|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6424|TWO_SIDED|90.0|-16.4|10.6|||Chan and Zhang method|||Week 10||10.6|-16.4|0.6424
73805372|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|10.7||||0.062|TWO_SIDED|90.0|-0.7|23.6|||Chan and Zhang method|||Week 14||23.6|-0.7|0.0620
73805373|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|2.8||||0.3402|TWO_SIDED|90.0|-7.0|13.4|||Chan and Zhang method|||Week 14||13.4|-7.0|0.3402
73805374|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|5.8||||0.1743|TWO_SIDED|90.0|-4.5|17.6|||Chan and Zhang method|||Week 14||17.6|-4.5|0.1743
73805375|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|10.7||||0.062|TWO_SIDED|90.0|-0.7|23.6|||Chan and Zhang method|||Week 14||23.6|-0.7|0.0620
73805376|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|2.6||||0.3534|TWO_SIDED|90.0|-7.8|15.4|||Chan and Zhang method|||Week 14||15.4|-7.8|0.3534
73805377|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|5.5||||0.2508|TWO_SIDED|90.0|-5.5|18.8|||Chan and Zhang method|||Week 14||18.8|-5.5|0.2508
73805378|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|1.9||||0.4238|TWO_SIDED|90.0|-8.2|13.6|||Chan and Zhang method|||Week 14||13.6|-8.2|0.4238
73805379|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|5.9||||0.2696|TWO_SIDED|90.0|-6.2|19.3|||Chan and Zhang method|||Week 16||19.3|-6.2|0.2696
73805380|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|3.0||||0.3648|TWO_SIDED|90.0|-8.6|15.3|||Chan and Zhang method|||Week 16||15.3|-8.6|0.3648
73805381|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|8.7||||0.1267|TWO_SIDED|90.0|-3.8|22.2|||Chan and Zhang method|||Week 16||22.2|-3.8|0.1267
73805382|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|10.7||||0.0832|TWO_SIDED|90.0|-2.5|24.4|||Chan and Zhang method|||Week 16||24.4|-2.5|0.0832
73805383|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|6.5||||0.2099|TWO_SIDED|90.0|-5.7|21.3|||Chan and Zhang method|||Week 16||21.3|-5.7|0.2099
73805384|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|3.6||||0.3474|TWO_SIDED|90.0|-8.0|17.4|||Chan and Zhang method|||Week 16||17.4|-8.0|0.3474
73805385|NCT03850483|147159997|SUPERIORITY||Risk Difference (RD)|8.1||||0.2124|TWO_SIDED|90.0|-4.0|21.6|||Chan and Zhang method|||Week 16||21.6|-4.0|0.2124
73805386|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|13.7||||0.0544|TWO_SIDED|90.0|-0.3|27.9|||Chan and Zhang method|||Week 1||27.9|-0.3|0.0544
73805387|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|6.1||||0.2697|TWO_SIDED|90.0|-6.3|19.6|||Chan and Zhang method|||Week 1||19.6|-6.3|0.2697
73805388|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|16.5||||0.0286|TWO_SIDED|90.0|2.0|31.0|||Chan and Zhang method|||Week 1||31.0|2.0|0.0286
73805389|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|7.8||||0.1512|TWO_SIDED|90.0|-4.7|20.8|||Chan and Zhang method|||Week 1||20.8|-4.7|0.1512
73805390|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|-7.7||||0.79|TWO_SIDED|90.0|-21.9|7.4|||Chan and Zhang method|||Week 1||7.4|-21.9|0.7900
73805391|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|7.3||||0.3137|TWO_SIDED|90.0|-8.5|24.0|||Chan and Zhang method|||Week 1||24.0|-8.5|0.3137
73805392|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|5.0||||0.3789|TWO_SIDED|90.0|-10.9|22.6|||Chan and Zhang method|||Week 1||22.6|-10.9|0.3789
73805393|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|13.7||||0.0636|TWO_SIDED|90.0|-1.0|28.5|||Chan and Zhang method|||Week 2||28.5|-1.0|0.0636
73805394|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|9.6||||0.1435|TWO_SIDED|90.0|-4.9|24.5|||Chan and Zhang method|||Week 2||24.5|-4.9|0.1435
73805395|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|25.7||||0.0058|TWO_SIDED|90.0|8.9|42.4|||Chan and Zhang method|||Week 2||42.4|8.9|0.0058
73805396|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|22.9||||0.0112|TWO_SIDED|90.0|6.5|38.9|||Chan and Zhang method|||Week 2||38.9|6.5|0.0112
73805397|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|4.9||||0.3349|TWO_SIDED|90.0|-10.8|21.3|||Chan and Zhang method|||Week 2||21.3|-10.8|0.3349
73805398|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|10.6||||0.2065|TWO_SIDED|90.0|-6.1|27.7|||Chan and Zhang method|||Week 2||27.7|-6.1|0.2065
73805399|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|11.4||||0.1871|TWO_SIDED|90.0|-5.6|29.1|||Chan and Zhang method|||Week 2||29.1|-5.6|0.1871
73805400|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|13.4||||0.1245|TWO_SIDED|90.0|-4.9|31.4|||Chan and Zhang method|||Week 4||31.4|-4.9|0.1245
73805401|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|14.0||||0.128|TWO_SIDED|90.0|-4.7|33.7|||Chan and Zhang method|||Week 4||33.7|-4.7|0.1280
73805402|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|32.9||||0.003|TWO_SIDED|90.0|12.4|50.5|||Chan and Zhang method|||Week 4||50.5|12.4|0.0030
73805403|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|22.6||||0.0235|TWO_SIDED|90.0|3.1|40.6|||Chan and Zhang method|||Week 4||40.6|3.1|0.0235
73805404|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|4.9||||0.3728|TWO_SIDED|90.0|-13.6|24.1|||Chan and Zhang method|||Week 4||24.1|-13.6|0.3728
73805405|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|25.5||||0.0153|TWO_SIDED|90.0|4.0|43.6|||Chan and Zhang method|||Week 4||43.6|4.0|0.0153
73805406|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|9.4||||0.2543|TWO_SIDED|90.0|-8.8|27.8|||Chan and Zhang method|||Week 4||27.8|-8.8|0.2543
73805407|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|7.9||||0.2785|TWO_SIDED|90.0|-10.2|26.4|||Chan and Zhang method|||Week 6||26.4|-10.2|0.2785
73805408|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|13.3||||0.1434|TWO_SIDED|90.0|-7.4|33.7|||Chan and Zhang method|||Week 6||33.7|-7.4|0.1434
73805409|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|36.1||||0.0015|TWO_SIDED|90.0|12.8|54.1|||Chan and Zhang method|||Week 6||54.1|12.8|0.0015
73805410|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|24.1||||0.0242|TWO_SIDED|90.0|3.4|43.9|||Chan and Zhang method|||Week 6||43.9|3.4|0.0242
73805411|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|35.1||||0.0037|TWO_SIDED|90.0|10.0|54.1|||Chan and Zhang method|||Week 6||54.1|10.0|0.0037
73805412|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|16.6||||0.1037|TWO_SIDED|90.0|-4.9|36.7|||Chan and Zhang method|||Week 6||36.7|-4.9|0.1037
73805413|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|1.8||||0.4607|TWO_SIDED|90.0|-17.7|22.5|||Chan and Zhang method|||Week 6||22.5|-17.7|0.4607
73805414|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|12.2||||0.1725|TWO_SIDED|90.0|-8.0|31.9|||Chan and Zhang method|||Week 8||31.9|-8.0|0.1725
73805415|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|22.8||||0.0451|TWO_SIDED|90.0|0.2|43.6|||Chan and Zhang method|||Week 8||43.6|0.2|0.0451
73805416|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|44.4||||0.0003|TWO_SIDED|90.0|21.3|62.9|||Chan and Zhang method|||Week 8||62.9|21.3|0.0003
73805417|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|26.7||||0.0239|TWO_SIDED|90.0|3.8|47.6|||Chan and Zhang method|||Week 8||47.6|3.8|0.0239
73805418|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|20.8||||0.0643|TWO_SIDED|90.0|-2.1|41.2|||Chan and Zhang method|||Week 8||41.2|-2.1|0.0643
73805419|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|-6.0||||0.6676|TWO_SIDED|90.0|-25.9|15.9|||Chan and Zhang method|||Week 8||15.9|-25.9|0.6676
73805420|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|17.6||||0.0898|TWO_SIDED|90.0|-4.2|37.8|||Chan and Zhang method|||Week 8||37.8|-4.2|0.0898
73805421|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|11.8||||0.2707|TWO_SIDED|90.0|-10.1|32.9|||Chan and Zhang method|||Week 10||32.9|-10.1|0.2707
73805422|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|9.0||||0.2981|TWO_SIDED|90.0|-14.2|31.0|||Chan and Zhang method|||Week 10||31.0|-14.2|0.2981
73805423|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|31.0||||0.011|TWO_SIDED|90.0|8.0|51.4|||Chan and Zhang method|||Week 10||51.4|8.0|0.0110
73805424|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|33.3||||0.0083|TWO_SIDED|90.0|9.1|53.2|||Chan and Zhang method|||Week 10||53.2|9.1|0.0083
73805425|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|4.8||||0.4217|TWO_SIDED|90.0|-18.3|27.5|||Chan and Zhang method|||Week 10||27.5|-18.3|0.4217
73805426|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|1.3||||0.5152|TWO_SIDED|90.0|-20.8|23.2|||Chan and Zhang method|||Week 10||23.2|-20.8|0.5152
73805427|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|-11.8||||0.7002|TWO_SIDED|90.0|-33.1|11.7|||Chan and Zhang method|||Week 10||11.7|-33.1|0.7002
73805428|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|27.6||||0.0169|TWO_SIDED|90.0|5.2|47.9|||Chan and Zhang method|||Week 12||47.9|5.2|0.0169
73805429|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|25.9||||0.0283|TWO_SIDED|90.0|3.2|46.2|||Chan and Zhang method|||Week 12||46.2|3.2|0.0283
73805430|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|37.9||||0.002|TWO_SIDED|90.0|14.3|57.1|||Chan and Zhang method|||Week 12||57.1|14.3|0.0020
73805431|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|31.4||||0.0095|TWO_SIDED|90.0|8.4|51.5|||Chan and Zhang method|||Week 12||51.5|8.4|0.0095
73805432|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|21.0||||0.0798|TWO_SIDED|90.0|-2.7|42.6|||Chan and Zhang method|||Week 12||42.6|-2.7|0.0798
73805433|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|10.9||||0.2848|TWO_SIDED|90.0|-11.3|31.8|||Chan and Zhang method|||Week 12||31.8|-11.3|0.2848
73805434|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|0.5||||0.5062|TWO_SIDED|90.0|-21.1|23.1|||Chan and Zhang method|||Week 12||23.1|-21.1|0.5062
73805435|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|36.9||||0.0012|TWO_SIDED|90.0|16.7|55.3|||Chan and Zhang method|||Week 14||55.3|16.7|0.0012
73805436|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|38.7||||0.0007|TWO_SIDED|90.0|17.3|57.4|||Chan and Zhang method|||Week 14||57.4|17.3|0.0007
73805437|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|47.0||||0.0001|TWO_SIDED|90.0|24.6|65.1|||Chan and Zhang method|||Week 14||65.1|24.6|0.0001
73805438|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|29.9||||0.0039|TWO_SIDED|90.0|9.5|48.7|||Chan and Zhang method|||Week 14||48.7|9.5|0.0039
73805439|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|4.5||||0.3895|TWO_SIDED|90.0|-17.5|26.5|||Chan and Zhang method|||Week 14||26.5|-17.5|0.3895
73805440|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|10.1||||0.2793|TWO_SIDED|90.0|-11.8|31.8|||Chan and Zhang method|||Week 14||31.8|-11.8|0.2793
73805441|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|-8.5||||0.7027|TWO_SIDED|90.0|-28.4|12.2|||Chan and Zhang method|||Week 14||12.2|-28.4|0.7027
73805442|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|37.0||||0.0009|TWO_SIDED|90.0|15.4|55.2|||Chan and Zhang method|||Week 16||55.2|15.4|0.0009
73805443|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|23.0||||0.0205|TWO_SIDED|90.0|4.1|43.2|||Chan and Zhang method|||Week 16||43.2|4.1|0.0205
73805444|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|46.8||||0.0001|TWO_SIDED|90.0|24.6|65.7|||Chan and Zhang method|||Week 16||65.7|24.6|0.0001
73805445|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|44.6||||0.0002|TWO_SIDED|90.0|21.5|62.9|||Chan and Zhang method|||Week 16||62.9|21.5|0.0002
73805446|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|-18.5||||0.9209|TWO_SIDED|90.0|-38.3|3.2|||Chan and Zhang method|||Week 16||3.2|-38.3|0.9209
73805447|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|-13.9||||0.793|TWO_SIDED|90.0|-34.4|8.7|||Chan and Zhang method|||Week 16||8.7|-34.4|0.7930
73805448|NCT03850483|147159998|SUPERIORITY||Risk Difference (RD)|-5.1||||0.6156|TWO_SIDED|90.0|-28.0|20.1|||Chan and Zhang method|||Week 16||20.1|-28.0|0.6156
73895501|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|3.4||||0.341|TWO_SIDED|95.0|-2.38|9.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 24||9.16|-2.38|0.341
73805449|NCT00652626|147160059|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|98.4|||||TWO_SIDED|90.0|64.0|151.3|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% confidence interval (CI) of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||151.3|64.0|
73805450|NCT00652626|147160059|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|67.5|||||TWO_SIDED|90.0|44.7|101.8|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||101.8|44.7|
73805451|NCT00652626|147160059|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|82.7|||||TWO_SIDED|90.0|53.8|127.2|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||127.2|53.8|
73805452|NCT00652626|147160060|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|97.4|||||TWO_SIDED|90.0|63.8|148.8|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||148.8|63.8|
73805453|NCT00652626|147160060|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|68.5|||||TWO_SIDED|90.0|45.7|102.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||102.7|45.7|
73805454|NCT00652626|147160060|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|83.2|||||TWO_SIDED|90.0|54.5|127.1|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||127.1|54.5|
73805455|NCT00652626|147160061|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|127.7|||||TWO_SIDED|90.0|66.3|245.7|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||245.7|66.3|
73805456|NCT00652626|147160061|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|84.7|||||TWO_SIDED|90.0|45.3|158.5|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||158.5|45.3|
73805457|NCT00652626|147160061|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|107.5|||||TWO_SIDED|90.0|55.9|207.0|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||207.0|55.9|
73805458|NCT00652626|147160064|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|101.1|||||TWO_SIDED|90.0|71.2|143.6|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||143.6|71.2|
73805459|NCT00652626|147160064|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|144.9|||||TWO_SIDED|90.0|103.6|202.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||202.7|103.6|
73805460|NCT00652626|147160064|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|101.4|||||TWO_SIDED|90.0|71.4|143.9|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||143.9|71.4|
73895502|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|18.3||||0.004|TWO_SIDED|95.0|8.4|28.27|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 28||28.27|8.40|0.004
73805461|NCT00652626|147160067|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|169.3|||||TWO_SIDED|90.0|109.2|262.5|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters"||262.5|109.2|
73895503|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|24.1|||<|0.001|TWO_SIDED|95.0|13.88|34.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 36||34.40|13.88|<0.001
73805462|NCT00652626|147160067|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|140.4|||||TWO_SIDED|90.0|90.6|217.7|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||217.7|90.6|
73805463|NCT00652626|147160068|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|166.3|||||TWO_SIDED|90.0|108.6|254.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||254.6|108.6|
73805464|NCT00652626|147160068|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|141.2|||||TWO_SIDED|90.0|92.2|216.2|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||216.2|92.2|
73805465|NCT00652626|147160069|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|141.7|||||TWO_SIDED|90.0|73.2|274.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||274.6|73.2|
73805466|NCT00652626|147160069|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|105.6|||||TWO_SIDED|90.0|54.5|204.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||204.6|54.5|
73805467|NCT00652626|147160070|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.25||||0.1342|TWO_SIDED|90.0|0.0|0.52|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.||0.52|0|0.1342
73805468|NCT00652626|147160070|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.25||||0.1017|TWO_SIDED|90.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.||0.50|0|0.1017
73805469|NCT02898597|147160081|SUPERIORITY||Odds Ratio (OR)|12.31|||<|0.05|TWO_SIDED|95.0|1.37|110.3|||Regression, Logistic|||||110.30|1.37|< 0.05
73805470|NCT02898597|147160081|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Fisher Exact test was performed, comparing the proportion of participants whose abstinence was verified with salivary cotinine test between the two arms, which was significant (p = 0.02).||||<0.05
73805471|NCT02498444|147160106|OTHER||Risk Ratio (RR)|1.29||||0.03|TWO_SIDED|95.0|1.02|1.64|||Poisson regression|Poisson regression model demonstrating associations between treatment groups and outcomes (chest tube duration in days and length of stay in days)||||1.64|1.02|0.03
73805472|NCT02498444|147160107|OTHER||Risk Ratio (RR)|1.23||||0.0498|TWO_SIDED|95.0|1.0|1.51||Poisson regression model demonstrating associations between treatment groups and outcomes (chest tube duration in days and length of stay in days)|Poisson regression|||||1.51|1.00|0.0498
73805473|NCT02498444|147160108|OTHER|||||||0.05|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.05
73805474|NCT02498444|147160108|OTHER||||||<|0.01|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||<0.01
73805475|NCT02498444|147160108|OTHER|||||||0.14|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.14
73805476|NCT02498444|147160109|OTHER|||||||0.23|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.23
73805477|NCT02498444|147160109|OTHER|||||||0.27|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||0.27
73805478|NCT02498444|147160109|OTHER|||||||0.65|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.65
73805479|NCT02498444|147160110|OTHER|||||||0.37|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.37
73805480|NCT02498444|147160110|OTHER||||||<|0.01|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||<0.01
73805481|NCT02498444|147160110|OTHER|||||||0.3|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.30
73805482|NCT02027545|147160111|SUPERIORITY|||||||0.491|||||||Regression, Logistic|||||||0.491
73805483|NCT02027545|147160112|SUPERIORITY|||||||0.049|||||||Regression, Logistic|||||||0.049
73805484|NCT02453334|147160114|OTHER||Odds Ratio (OR)|0.51||||0.0143|TWO_SIDED|95.0|0.3|0.87|||Cochran-Mantel-Haenszel|||||0.87|0.30|0.0143
73805485|NCT02453334|147160114|OTHER||Percentage difference|-15.6|||||TWO_SIDED|95.0|-28.01|-3.1||||||||-3.10|-28.01|
73805486|NCT02453334|147160116|OTHER||Odds Ratio (OR)|2.04||||0.0097|TWO_SIDED|95.0|1.19|3.5|||Cochran-Mantel-Haenszel|||||3.50|1.19|0.0097
73805487|NCT02453334|147160116|OTHER||Percentage difference|16.4|||||TWO_SIDED|95.0|4.19|28.51||||||Percentage difference||28.51|4.19|
73805488|NCT02453334|147160117|OTHER||Percentage difference|-2.7|||||TWO_SIDED|95.0|-12.85|7.45||||||||7.45|-12.85|
73805489|NCT02453334|147160117|OTHER||Odds Ratio (OR)|0.83||||0.5758|TWO_SIDED|95.0|0.43|1.6|||Cochran-Mantel-Haenszel|||Placebo group was used as the denominator for odds ratio calculation.||1.60|0.43|0.5758
73805490|NCT02453334|147160118|OTHER||Odds Ratio (OR)|1.4||||0.2772|TWO_SIDED|95.0|0.76|2.56||Placebo group was used as the denominator for odds ratio calculation|Cochran-Mantel-Haenszel|||||2.56|0.76|0.2772
73805491|NCT02453334|147160118|OTHER||Percentage difference|5.7|||||TWO_SIDED|95.0|-5.01|16.43||||||||16.43|-5.01|
73805492|NCT02453334|147160119|OTHER|||||||0.0011|||||||Log Rank|P-value was estimated using logrank test stratified by country||||||0.0011
73805493|NCT02453334|147160120|OTHER||Percentage difference|0.7|||||TWO_SIDED|95.0|-7.6|9.08||||||||9.08|-7.60|
73805494|NCT02453334|147160120|OTHER||Odds Ratio (OR)|1.05||||0.8924|TWO_SIDED|95.0|0.49|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.49|0.8924
73805495|NCT02453334|147160121|OTHER||Percentage difference|-9.8|||||TWO_SIDED|95.0|-20.41|0.77||||||||0.77|-20.41|
73895504|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|27.1|||<|0.001|TWO_SIDED|95.0|16.85|37.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 44||37.35|16.85|<0.001
73895505|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|24.0|||<|0.001|TWO_SIDED|95.0|13.61|34.42|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 52||34.42|13.61|<0.001
73895506|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|2.3||||0.774|TWO_SIDED|95.0|-5.5|10.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 24||10.06|-5.50|0.774
73805496|NCT02453334|147160121|OTHER||Odds Ratio (OR)|0.55||||0.074|TWO_SIDED|95.0|0.28|1.06|||Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation.||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country. Placebo group was used as the denominator for odds ratio calculation.||1.06|0.28|0.0740
73805497|NCT02453334|147160122|OTHER||Percentage difference|-12.1|||||TWO_SIDED|95.0|-23.31|-0.91||||||||-0.91|-23.31|
73805498|NCT02453334|147160122|OTHER||Odds Ratio (OR)|0.51||||0.0446|TWO_SIDED|95.0|0.26|0.99||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation||||0.99|0.26|0.0446
73805499|NCT02453334|147160123|OTHER||Percentage difference|-19.8|||||TWO_SIDED|95.0|-30.9|-8.69||||||||-8.69|-30.90|
73805500|NCT02453334|147160123|OTHER||Odds Ratio (OR)|0.3||||0.001|TWO_SIDED|95.0|0.14|0.63||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation.||||0.63|0.14|0.0010
73805501|NCT02453334|147160124|OTHER||Percentage difference|-21.4|||||TWO_SIDED|95.0|-33.22|-9.51||||||||-9.51|-33.22|
73805502|NCT02453334|147160124|OTHER||Odds Ratio (OR)|0.29||||0.0009|TWO_SIDED|95.0|0.13|0.61||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||0.61|0.13|0.0009
73805503|NCT02453334|147160125|OTHER||Percentage difference|-16.0|||||TWO_SIDED|95.0|-27.73|-4.26||||||||-4.26|-27.73|
73805504|NCT02453334|147160125|OTHER||Odds Ratio (OR)|0.34||||0.0093|TWO_SIDED|95.0|0.14|0.79||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||0.79|0.14|0.0093
73805505|NCT02453334|147160126|OTHER||Percentage difference|-4.4|||||TWO_SIDED|95.0|-15.37|6.57||||||||6.57|-15.37|
73805506|NCT02453334|147160126|OTHER||Odds Ratio (OR)|0.7||||0.4786|TWO_SIDED|95.0|0.26|1.89||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||1.89|0.26|0.4786
73805507|NCT02453334|147160127|OTHER||Percentage difference|-7.4|||||TWO_SIDED|95.0|-19.25|4.55||||||||4.55|-19.25|
73805508|NCT02453334|147160127|OTHER||Odds Ratio (OR)|0.54||||0.2084|TWO_SIDED|95.0|0.2|1.43||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||1.43|0.20|0.2084
73805509|NCT02453334|147160128|OTHER||Percentage difference|3.1|||||TWO_SIDED|95.0|-9.33|15.54||||||||15.54|-9.33|
73805510|NCT02453334|147160128|OTHER||Odds Ratio (OR)|1.25||||0.6508|TWO_SIDED|95.0|0.48|3.24|||Cochran-Mantel-Haenszel|The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Placebo group was used as the denominator for odds ratio calculation.|||3.24|0.48|0.6508
73805511|NCT02453334|147160130|OTHER|||||||0.0063||||||P-value was estimated using logrank test stratified by pooled sites.|Log Rank|||||||0.0063
73805512|NCT00693498|147160134|OTHER||||||<|0.03||||||the reported value is for POD#1 assessment|Wald Wolfowitz|||||||<0.03
73805513|NCT00693498|147160134|OTHER|||||||0.29||||||for POD#2 assessment|Wald-Wolf|||||||0.29
73895507|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|0.4||||0.645|TWO_SIDED|95.0|-7.15|8.03|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 28||8.03|-7.15|0.645
73895508|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|8.4||||0.08|TWO_SIDED|95.0|0.36|16.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 36||16.35|0.36|0.080
73895509|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|9.6||||0.025|TWO_SIDED|95.0|1.49|17.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 44||17.68|1.49|0.025
73805514|NCT02074358|147160145|SUPERIORITY_OR_OTHER||mixed effect model|425.3|||<|0.001|TWO_SIDED|95.0|219.8|630.7|||Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||630.7|219.8|<0.001
73805515|NCT02074358|147160145|SUPERIORITY_OR_OTHER||mixed effect model|90.6||||0.131|TWO_SIDED|95.0|-31.3|212.4||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for any secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||212.4|-31.3|0.131
73805516|NCT02074358|147160146|SUPERIORITY_OR_OTHER||mixed effect model|-0.21||||0.389|TWO_SIDED|95.0|-0.73|0.3||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for other secondary endpoints since a non-significant treatment difference was observed for this first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|TGA Lag Time. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.30|-0.73|0.389
73805517|NCT02074358|147160146|SUPERIORITY_OR_OTHER||mixed effect model|-0.16||||0.142|TWO_SIDED|95.0|-0.38|0.06||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Lag Time. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.06|-0.38|0.142
73805518|NCT02074358|147160146|SUPERIORITY_OR_OTHER||mixed effect model|1.35||||0.2|TWO_SIDED|95.0|-0.81|3.52||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||3.52|-0.81|0.200
73805519|NCT02074358|147160146|SUPERIORITY_OR_OTHER||mixed effect model|4.62|||<|0.001|TWO_SIDED|95.0|2.8|6.44||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||6.44|2.80|<0.001
73805520|NCT02074358|147160147|SUPERIORITY_OR_OTHER||mixed effect model|21.1||||0.014|TWO_SIDED|95.0|4.9|37.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||37.2|4.9|0.014
73805521|NCT02074358|147160147|SUPERIORITY_OR_OTHER||mixed effect model|-6.4||||0.076|TWO_SIDED|95.0|-13.5|0.8||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.8|-13.5|0.076
73895510|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|9.0||||0.088|TWO_SIDED|95.0|1.02|16.88|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 52||16.88|1.02|0.088
73895511|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Baseline||1.81|-0.59|0.358
73805522|NCT02074358|147160148|SUPERIORITY_OR_OTHER||mixed effect model|0.0||||0.996|TWO_SIDED|95.0|-5.6|5.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||5.6|-5.6|0.996
73805523|NCT02074358|147160148|SUPERIORITY_OR_OTHER||mixed effect model|-6.5|||<|0.001|TWO_SIDED|95.0|-9.5|-3.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-3.6|-9.5|<0.001
73805524|NCT02074358|147160149|SUPERIORITY_OR_OTHER||mixed effect model|-1.64|||<|0.001|TWO_SIDED|95.0|-2.16|-1.12||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model that included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.12|-2.16|<0.001
73805525|NCT02074358|147160149|SUPERIORITY_OR_OTHER||mixed effect model|-1.47|||<|0.001|TWO_SIDED|95.0|-1.95|-0.99||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.99|-1.95|<0.001
73805526|NCT02074358|147160149|SUPERIORITY_OR_OTHER||mixed effect model|-2.59|||<|0.001|TWO_SIDED|95.0|-3.3|-1.89||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.89|-3.30|<0.001
73805527|NCT02074358|147160149|SUPERIORITY_OR_OTHER||mixed effect model|-1.89|||<|0.001|TWO_SIDED|95.0|-2.59|-1.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.20|-2.59|<0.001
73805528|NCT02074358|147160149|SUPERIORITY_OR_OTHER||mixed effect model|8.47|||<|0.001|TWO_SIDED|95.0|6.29|10.66||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|aPTT. The ETP change from pre-PCC baseline was analyzed using a mixed effect model and included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||10.66|6.29|<0.001
73805529|NCT02074358|147160149|SUPERIORITY_OR_OTHER||mixed effect model|2.3|||<|0.001|TWO_SIDED|95.0|1.28|3.32||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|aPTT. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||3.32|1.28|<0.001
73895512|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|3.3||||0.258|TWO_SIDED|95.0|-3.57|10.13|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 24||10.13|-3.57|0.258
73805530|NCT02074358|147160150|SUPERIORITY_OR_OTHER||mixed effect model|-0.198|||<|0.001|TWO_SIDED|95.0|-0.266|-0.13||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.130|-0.266|<0.001
73805531|NCT02074358|147160150|SUPERIORITY_OR_OTHER||mixed effect model|-0.17|||<|0.001|TWO_SIDED|95.0|-0.229|-0.111||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.111|-0.229|<0.001
73805532|NCT02074358|147160150|SUPERIORITY_OR_OTHER||mixed effect model|-0.239|||<|0.001|TWO_SIDED|95.0|-0.305|-0.173||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.173|-0.305|<0.001
73805533|NCT02074358|147160150|SUPERIORITY_OR_OTHER||mixed effect model|-0.176|||<|0.001|TWO_SIDED|95.0|-0.242|-0.11||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.110|-0.242|<0.001
73805534|NCT02074358|147160151|SUPERIORITY_OR_OTHER||mixed effect models|-0.239||||0.204|TWO_SIDED|95.0|-0.625|0.146||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.146|-0.625|0.204
73805535|NCT02074358|147160151|SUPERIORITY_OR_OTHER||mixed effect models|-0.17||||0.114|TWO_SIDED|95.0|-0.389|0.048||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.048|-0.389|0.114
73805536|NCT02074358|147160161|SUPERIORITY_OR_OTHER||mixed effect model|1.039|||||TWO_SIDED|90.0|0.972|1.111|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A, and Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.111|0.972|
73805537|NCT02074358|147160161|SUPERIORITY_OR_OTHER||mixed effect model|1.021|||||TWO_SIDED|90.0|0.938|1.112|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.112|0.938|
73805538|NCT02074358|147160163|SUPERIORITY_OR_OTHER||mixed effect model|1.019|||||TWO_SIDED|90.0|0.955|1.087|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A). No adjustment was made for multiplicity.||1.087|0.955|
73895513|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|17.7||||0.005|TWO_SIDED|95.0|7.49|27.92|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 28||27.92|7.49|0.005
73805539|NCT02074358|147160163|SUPERIORITY_OR_OTHER||mixed effect model|1.018|||||TWO_SIDED|90.0|0.94|1.102|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.102|0.940|
73805540|NCT01164579|147160180|SUPERIORITY_OR_OTHER||Difference in least squares (LS) Mean|-0.63|STANDARD_ERROR_OF_MEAN|0.57||0.2696|TWO_SIDED|90.0|-1.58|0.31||2-sided p-value; alpha equals (=) 0.10|mixed model repeated measures analysis|||||0.31|-1.58|0.2696
73805541|NCT01164579|147160180|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.52|STANDARD_ERROR_OF_MEAN|0.57||0.3561|TWO_SIDED|90.0|-1.46|0.41||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||||0.41|-1.46|0.3561
73805542|NCT01164579|147160181|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.55|STANDARD_ERROR_OF_MEAN|0.59||0.0089|TWO_SIDED|90.0|-2.52|-0.58||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis|||||-0.58|-2.52|0.0089
73805543|NCT01164579|147160181|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.74|STANDARD_ERROR_OF_MEAN|0.59||0.0038|TWO_SIDED|90.0|-2.72|-0.76||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis|||||-0.76|-2.72|0.0038
73805544|NCT01164579|147160182|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.57||0.6576|TWO_SIDED|90.0|-1.19|0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.69|-1.19|0.6576
73805545|NCT01164579|147160182|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.17|STANDARD_ERROR_OF_MEAN|0.55||0.7565|TWO_SIDED|90.0|-1.09|0.74||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.74|-1.09|0.7565
73805546|NCT01164579|147160182|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.94|STANDARD_ERROR_OF_MEAN|0.58||0.1038|TWO_SIDED|90.0|-1.89|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.01|-1.89|0.1038
73805547|NCT01164579|147160182|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.59||0.0868|TWO_SIDED|90.0|-1.98|-0.04||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.04|-1.98|0.0868
73805548|NCT01164579|147160182|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.6|STANDARD_ERROR_OF_MEAN|0.62||0.0103|TWO_SIDED|90.0|-2.62|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.58|-2.62|0.0103
73805549|NCT01164579|147160182|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.63||0.435|TWO_SIDED|90.0|-1.53|0.55||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.55|-1.53|0.4350
73895514|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.93|37.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 36||37.55|16.93|<0.001
73895515|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|32.0|||<|0.001|TWO_SIDED|95.0|21.83|42.23|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 44||42.23|21.83|<0.001
73895516|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|28.3|||<|0.001|TWO_SIDED|95.0|18.0|38.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 52||38.69|18.00|<0.001
73805550|NCT01164579|147160183|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.58||0.489|TWO_SIDED|90.0|-1.36|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.56|-1.36|0.4890
73805551|NCT01164579|147160183|SUPERIORITY_OR_OTHER||Difference in LS Means|0.08|STANDARD_ERROR_OF_MEAN|0.57||0.8817|TWO_SIDED|90.0|-0.85|1.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||1.02|-0.85|0.8817
73805552|NCT01164579|147160183|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.24|STANDARD_ERROR_OF_MEAN|0.59||0.0351|TWO_SIDED|90.0|-2.21|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.27|-2.21|0.0351
73805553|NCT01164579|147160183|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.32|STANDARD_ERROR_OF_MEAN|0.58||0.0231|TWO_SIDED|90.0|-2.28|-0.37||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.37|-2.28|0.0231
73805554|NCT01164579|147160183|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1|STANDARD_ERROR_OF_MEAN|0.62||0.0008|TWO_SIDED|90.0|-3.13|-1.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-1.08|-3.13|0.0008
73805555|NCT01164579|147160183|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.29|STANDARD_ERROR_OF_MEAN|0.63||0.0003|TWO_SIDED|90.0|-3.32|-1.25||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-1.25|-3.32|0.0003
73805556|NCT01164579|147160184|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.35||0.2689|TWO_SIDED|90.0|-0.96|0.19||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.19|-0.96|0.2689
73805557|NCT01164579|147160184|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9935|TWO_SIDED|90.0|-0.58|0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.57|-0.58|0.9935
73805558|NCT01164579|147160184|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.35||0.1086|TWO_SIDED|90.0|-1.15|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.01|-1.15|0.1086
73805559|NCT01164579|147160184|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.08|STANDARD_ERROR_OF_MEAN|0.35||0.8092|TWO_SIDED|90.0|-0.66|0.49||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.49|-0.66|0.8092
73805560|NCT01164579|147160184|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.35||0.0463|TWO_SIDED|90.0|-1.29|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.12|-1.29|0.0463
73805561|NCT01164579|147160184|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.35||0.0624|TWO_SIDED|90.0|-1.25|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.25|0.0624
73895517|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|3.0||||0.672|TWO_SIDED|95.0|-5.51|11.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 24||11.51|-5.51|0.672
73805562|NCT01164579|147160184|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.29|STANDARD_ERROR_OF_MEAN|0.37||0.0005|TWO_SIDED|90.0|-1.9|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.69|-1.90|0.0005
73805563|NCT01164579|147160184|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.26|STANDARD_ERROR_OF_MEAN|0.37||0.0008|TWO_SIDED|90.0|-1.87|-0.65||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.65|-1.87|0.0008
73805564|NCT01164579|147160185|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5019|TWO_SIDED|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.71|-1.68|0.5019
73805565|NCT01164579|147160185|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.73||0.1462|TWO_SIDED|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.14|-2.28|0.1462
73805566|NCT01164579|147160185|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.74||0.49|TWO_SIDED|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.72|-1.74|0.4900
73805567|NCT01164579|147160185|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.51|STANDARD_ERROR_OF_MEAN|0.75||0.0459|TWO_SIDED|90.0|-2.76|-0.27|||mixed model repeated measures analysis|||Month 12||-0.27|-2.76|0.0459
73805568|NCT01164579|147160186|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5019|TWO_SIDED|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.71|-1.68|0.5019
73805569|NCT01164579|147160186|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.73||0.1462|TWO_SIDED|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.14|-2.28|0.1462
73805570|NCT01164579|147160186|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.74||0.49|TWO_SIDED|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.72|-1.74|0.4900
73805571|NCT01164579|147160186|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.51|STANDARD_ERROR_OF_MEAN|0.75||0.0459|TWO_SIDED|90.0|-2.76|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.27|-2.76|0.0459
73805572|NCT01164579|147160187|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.5||0.8959|TWO_SIDED|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.76|-0.89|0.8959
73895518|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||0.556|TWO_SIDED|95.0|-8.03|8.0|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 28||8.00|-8.03|0.556
73895519|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|10.3||||0.022|TWO_SIDED|95.0|2.07|18.45|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 36||18.45|2.07|0.022
73805573|NCT01164579|147160187|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.5||0.4193|TWO_SIDED|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.43|-1.25|0.4193
73805574|NCT01164579|147160187|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.51||0.5764|TWO_SIDED|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.56|-1.13|0.5764
73805575|NCT01164579|147160187|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1101|TWO_SIDED|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.02|-1.69|0.1101
73805576|NCT01164579|147160188|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.5||0.8959|TWO_SIDED|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.76|-0.89|0.8959
73805577|NCT01164579|147160188|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.5||0.4193|TWO_SIDED|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.43|-1.25|0.4193
73805578|NCT01164579|147160188|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.51||0.5764|TWO_SIDED|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.56|-1.13|0.5764
73805579|NCT01164579|147160188|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1101|TWO_SIDED|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.02|-1.69|0.1101
73805580|NCT01164579|147160189|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.35||0.2351|TWO_SIDED|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.16|-1.00|0.2351
73805581|NCT01164579|147160189|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0631|TWO_SIDED|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.27|0.0631
73805582|NCT01164579|147160189|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.23|STANDARD_ERROR_OF_MEAN|0.36||0.5369|TWO_SIDED|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.38|-0.83|0.5369
73805583|NCT01164579|147160189|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.062|TWO_SIDED|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.08|-1.31|0.0620
73805584|NCT01164579|147160190|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.35||0.2351|TWO_SIDED|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.16|-1.00|0.2351
73805585|NCT01164579|147160190|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0631|TWO_SIDED|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.27|0.0631
73805586|NCT01164579|147160190|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.23|STANDARD_ERROR_OF_MEAN|0.36||0.5369|TWO_SIDED|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.38|-0.83|0.5369
73805587|NCT01164579|147160190|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.062|TWO_SIDED|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.08|-1.31|0.0620
73895520|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|9.0||||0.047|TWO_SIDED|95.0|0.85|17.25|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 44||17.25|0.85|0.047
73805588|NCT01164579|147160191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.12|STANDARD_ERROR_OF_MEAN|11.24||0.243|TWO_SIDED|90.0|-5.36|31.62|||Normal approximation to the binomial|||Month 1||31.62|-5.36|0.2430
73805589|NCT01164579|147160191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 1||45.90|8.91|0.0147
73805590|NCT01164579|147160191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.03|STANDARD_ERROR_OF_MEAN|11.25||0.0127|TWO_SIDED|90.0|9.51|46.54|||Normal approximation to the binomial|||Month 2||46.54|9.51|0.0127
73805591|NCT01164579|147160191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.57|STANDARD_ERROR_OF_MEAN|11.45||0.0724|TWO_SIDED|90.0|1.73|39.41|||Normal approximation to the binomial|||Month 2||39.41|1.73|0.0724
73805592|NCT01164579|147160191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.49|STANDARD_ERROR_OF_MEAN|10.85||0.0086|TWO_SIDED|90.0|10.63|46.35|||Normal approximation to the binomial|||Month 3||46.35|10.63|0.0086
73805593|NCT01164579|147160191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.46|STANDARD_ERROR_OF_MEAN|11.55||0.2808|TWO_SIDED|90.0|-6.54|31.47|||Normal approximation to the binomial|||Month 3||31.47|-6.54|0.2808
73805594|NCT01164579|147160191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 9||46.55|9.81|0.0115
73805595|NCT01164579|147160191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.09|STANDARD_ERROR_OF_MEAN|11.56||0.1921|TWO_SIDED|90.0|-3.94|34.12|||Normal approximation to the binomial|||Month 9||34.12|-3.94|0.1921
73805596|NCT01164579|147160191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 12||46.55|9.81|0.0115
73805597|NCT01164579|147160191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.86|STANDARD_ERROR_OF_MEAN|11.5||0.1203|TWO_SIDED|90.0|-1.05|36.79|||Normal approximation to the binomial|||Month 12||36.79|-1.05|0.1203
73805598|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.15|STANDARD_ERROR_OF_MEAN|7.58||0.0078|TWO_SIDED|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1||32.62|7.68|0.0078
73805599|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.15|STANDARD_ERROR_OF_MEAN|7.58||0.0078|TWO_SIDED|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1||32.62|7.68|0.0078
73805600|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.49|STANDARD_ERROR_OF_MEAN|10.37||0.0044|TWO_SIDED|90.0|12.43|46.56|||Normal approximation to the binomial|||Month 2||46.56|12.43|0.0044
73895521|NCT01578850|147324498|SUPERIORITY_OR_OTHER||Difference in proportions|12.1||||0.031|TWO_SIDED|95.0|3.7|20.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 52||20.57|3.70|0.031
73805601|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.11|STANDARD_ERROR_OF_MEAN|9.92||0.0845|TWO_SIDED|90.0|0.79|33.43|||Normal approximation to the binomial|||Month 2||33.43|0.79|0.0845
73805602|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.24|STANDARD_ERROR_OF_MEAN|11.0||0.0275|TWO_SIDED|90.0|6.14|42.35|||Normal approximation to the binomial|||Month 3||42.35|6.14|0.0275
73805603|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.67|STANDARD_ERROR_OF_MEAN|10.91||0.0186|TWO_SIDED|90.0|7.71|43.63|||Normal approximation to the binomial|||Month 3||43.63|7.71|0.0186
73805604|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.52|STANDARD_ERROR_OF_MEAN|10.75||0.0009|TWO_SIDED|90.0|17.82|53.22|||Normal approximation to the binomial|||Month 6||53.22|17.82|0.0009
73805605|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.6|STANDARD_ERROR_OF_MEAN|10.72||0.0169|TWO_SIDED|90.0|7.95|43.24|||Normal approximation to the binomial|||Month 6||43.24|7.95|0.0169
73805606|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 9||45.90|8.91|0.0147
73805607|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.71|STANDARD_ERROR_OF_MEAN|11.18||0.1882|TWO_SIDED|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 9||33.11|-3.68|0.1882
73805608|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 12||45.90|8.91|0.0147
73805609|NCT01164579|147160192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.71|STANDARD_ERROR_OF_MEAN|11.18||0.1882|TWO_SIDED|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 12||33.11|-3.68|0.1882
73805610|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.57|STANDARD_ERROR_OF_MEAN|4.73||0.07|TWO_SIDED|90.0|0.78|16.35|||Normal approximation to the binomial|||Month 1||16.35|0.78|0.0700
73805611|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|2.81||0.3102|TWO_SIDED|90.0|-1.77|7.48|||Normal approximation to the binomial|||Month 1||7.48|-1.77|0.3102
73805612|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.02|STANDARD_ERROR_OF_MEAN|8.68||0.0027|TWO_SIDED|90.0|11.73|40.3|||Normal approximation to the binomial|||Month 2||40.30|11.73|0.0027
73805613|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.81|STANDARD_ERROR_OF_MEAN|7.86||0.0324|TWO_SIDED|90.0|3.88|29.75|||Normal approximation to the binomial|||Month 2||29.75|3.88|0.0324
73805614|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|8.97||0.0969|TWO_SIDED|90.0|0.13|29.67|||Normal approximation to the binomial|||Month 3||29.67|0.13|0.0969
73805615|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.96|STANDARD_ERROR_OF_MEAN|9.04||0.0606|TWO_SIDED|90.0|2.09|31.84|||Normal approximation to the binomial|||Month 3||31.84|2.09|0.0606
73805616|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.66|STANDARD_ERROR_OF_MEAN|10.49||0.2276|TWO_SIDED|90.0|-4.6|29.93|||Normal approximation to the binomial|||Month 6||29.93|-4.60|0.2276
73805617|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.93|STANDARD_ERROR_OF_MEAN|10.23||0.3827|TWO_SIDED|90.0|-7.9|25.76|||Normal approximation to the binomial|||Month 6||25.76|-7.90|0.3827
73805618|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|10.15||0.2177|TWO_SIDED|90.0|-4.18|29.2|||Normal approximation to the binomial|||Month 9||29.20|-4.18|0.2177
73805619|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|STANDARD_ERROR_OF_MEAN|10.15||0.1558|TWO_SIDED|90.0|-2.29|31.12|||Normal approximation to the binomial|||Month 9||31.12|-2.29|0.1558
73805620|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|9.8||0.8997|TWO_SIDED|90.0|-14.89|17.36|||Normal approximation to the binomial|||Month 12||17.36|-14.89|0.8997
73805621|NCT01164579|147160193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.71|STANDARD_ERROR_OF_MEAN|10.36||0.2587|TWO_SIDED|90.0|-5.34|28.76|||Normal approximation to the binomial|||Month 12||28.76|-5.34|0.2587
73805622|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|90.0|-0.56|0.13||||||Baseline||0.13|-0.56|
73805623|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|90.0|-0.19|0.43||||||Baseline||0.43|-0.19|
73805624|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|90.0|-1.38|-0.5||||||Month 1||-0.50|-1.38|
73805625|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|90.0|-1.01|-0.22||||||Month 1||-0.22|-1.01|
73805626|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|90.0|-1.73|-0.7||||||Month 2||-0.70|-1.73|
73805627|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|90.0|-1.2|-0.18||||||Month 2||-0.18|-1.20|
73805628|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||||TWO_SIDED|90.0|-1.33|-0.29||||||Month 3||-0.29|-1.33|
73805629|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|90.0|-0.94|0.12||||||Month 3||0.12|-0.94|
73805630|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|90.0|-1.75|-0.61||||||Month 6||-0.61|-1.75|
73805631|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|90.0|-1.73|-0.63||||||Month 6||-0.63|-1.73|
73805632|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|90.0|-1.81|-0.61||||||Month 9||-0.61|-1.81|
73805633|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||||TWO_SIDED|90.0|-1.33|-0.13||||||Month 9||-0.13|-1.33|
73805634|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|90.0|-1.69|-0.51||||||Month 12||-0.51|-1.69|
73805635|NCT01164579|147160194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|90.0|-1.51|-0.29||||||Month 12||-0.29|-1.51|
73805636|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.26||0.001|TWO_SIDED|90.0|-1.31|-0.45||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.45|-1.31|0.0010
73805637|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.26||0.0102|TWO_SIDED|90.0|-1.1|-0.24||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.24|-1.10|0.0102
73805638|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.08|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|90.0|-1.52|-0.64||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.64|-1.52|<0.0001
73805639|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.27||0.0175|TWO_SIDED|90.0|-1.08|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.20|-1.08|0.0175
73805640|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.68|STANDARD_ERROR_OF_MEAN|0.27||0.0125|TWO_SIDED|90.0|-1.13|-0.23||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.23|-1.13|0.0125
73805641|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.1457|TWO_SIDED|90.0|-0.84|0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.05|-0.84|0.1457
73805642|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.28||0.0003|TWO_SIDED|90.0|-1.48|-0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.57|-1.48|0.0003
73805643|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.03|STANDARD_ERROR_OF_MEAN|0.28||0.0002|TWO_SIDED|90.0|-1.49|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.58|-1.49|0.0002
73805644|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|90.0|-1.63|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.69|-1.63|<0.0001
73805645|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.28||0.0196|TWO_SIDED|90.0|-1.14|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.20|-1.14|0.0196
73805646|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.3||0.0007|TWO_SIDED|90.0|-1.5|-0.52||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.52|-1.50|0.0007
73805647|NCT01164579|147160195|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.3||0.0049|TWO_SIDED|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.35|-1.32|0.0049
73805648|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|90.0|-0.53|0.15||||||Baseline||0.15|-0.53|
73805649|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|90.0|-0.24|0.36||||||Baseline||0.36|-0.24|
73805650|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|90.0|-1.4|-0.42||||||Month 1||-0.42|-1.40|
73805651|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|90.0|-1.01|-0.14||||||Month 1||-0.14|-1.01|
73805652|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|90.0|-1.82|-0.73||||||Month 2||-0.73|-1.82|
73805653|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|90.0|-1.25|-0.13||||||Month 2||-0.13|-1.25|
73805654|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|90.0|-1.55|-0.38||||||Month 3||-0.38|-1.55|
73805655|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|90.0|-1.12|0.11||||||Month 3||0.11|-1.12|
73805656|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|||||TWO_SIDED|90.0|-2.13|-0.72||||||Month 6||-0.72|-2.13|
73805657|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||||TWO_SIDED|90.0|-1.91|-0.57||||||Month 6||-0.57|-1.91|
73805658|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-1.84|-0.39||||||Month 9||-0.39|-1.84|
73805659|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|90.0|-1.3|0.13||||||Month 9||0.13|-1.30|
73805660|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-1.84|-0.39||||||Month 12||-0.39|-1.84|
73805661|NCT01164579|147160196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|90.0|-1.43|0.11||||||Month 12||0.11|-1.43|
73805662|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.29||0.0046|TWO_SIDED|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.35|-1.32|0.0046
73805663|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.29||0.0303|TWO_SIDED|90.0|-1.11|-0.15||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.15|-1.11|0.0303
73805664|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.18|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|90.0|-1.69|-0.68||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.68|-1.69|0.0001
73805665|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.3||0.0255|TWO_SIDED|90.0|-1.17|-0.18||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.18|-1.17|0.0255
73805666|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.3||0.0035|TWO_SIDED|90.0|-1.39|-0.39||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.39|-1.39|0.0035
73805667|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.3||0.0683|TWO_SIDED|90.0|-1.05|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.05|-1.05|0.0683
73805668|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.29|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|90.0|-1.81|-0.78||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.78|-1.81|<0.0001
73805669|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.08|STANDARD_ERROR_OF_MEAN|0.31||0.0006|TWO_SIDED|90.0|-1.59|-0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.56|-1.59|0.0006
73805670|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.15|STANDARD_ERROR_OF_MEAN|0.32||0.0004|TWO_SIDED|90.0|-1.67|-0.62||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.62|-1.67|0.0004
73805671|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.32||0.0706|TWO_SIDED|90.0|-1.1|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.05|-1.10|0.0706
73805672|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.13|STANDARD_ERROR_OF_MEAN|0.33||0.0008|TWO_SIDED|90.0|-1.67|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.58|-1.67|0.0008
73805673|NCT01164579|147160197|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.33||0.0466|TWO_SIDED|90.0|-1.21|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.12|-1.21|0.0466
73805674|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.51|STANDARD_ERROR_OF_MEAN|11.04||0.0032|TWO_SIDED|90.0|14.34|50.68||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||50.68|14.34|0.0032
73805675|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||46.55|9.81|0.0115
73805676|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.41|STANDARD_ERROR_OF_MEAN|9.48||0.0002|TWO_SIDED|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||50.02|18.81|0.0002
73805677|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.79|STANDARD_ERROR_OF_MEAN|10.48||0.0231|TWO_SIDED|90.0|6.55|41.03||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||41.03|6.55|0.0231
73805678|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.41|STANDARD_ERROR_OF_MEAN|9.48||0.0002|TWO_SIDED|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||50.02|18.81|0.0002
73805679|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.02|STANDARD_ERROR_OF_MEAN|10.69||0.0493|TWO_SIDED|90.0|3.43|38.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||38.61|3.43|0.0493
73805680|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.18|STANDARD_ERROR_OF_MEAN|9.88||0.0005|TWO_SIDED|90.0|17.92|50.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||50.43|17.92|0.0005
73805681|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.72|STANDARD_ERROR_OF_MEAN|10.73||0.027|TWO_SIDED|90.0|6.07|41.37||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||41.37|6.07|0.0270
73805682|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.46|STANDARD_ERROR_OF_MEAN|10.73||0.0018|TWO_SIDED|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||51.12|15.80|0.0018
73805683|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.49|STANDARD_ERROR_OF_MEAN|11.22||0.0363|TWO_SIDED|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||41.96|5.02|0.0363
73805684|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.4|STANDARD_ERROR_OF_MEAN|10.48||0.0005|TWO_SIDED|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||53.64|19.16|0.0005
73805685|NCT01164579|147160198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.27|STANDARD_ERROR_OF_MEAN|11.08||0.0177|TWO_SIDED|90.0|8.04|44.5||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||44.50|8.04|0.0177
73805686|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.52|STANDARD_ERROR_OF_MEAN|9.66||0.0197|TWO_SIDED|90.0|6.62|38.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||38.42|6.62|0.0197
73805687|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|STANDARD_ERROR_OF_MEAN|8.16||0.4379|TWO_SIDED|90.0|-7.09|19.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||19.76|-7.09|0.4379
73805688|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.37|STANDARD_ERROR_OF_MEAN|10.92||0.0093|TWO_SIDED|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||46.34|10.40|0.0093
73805689|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.48|STANDARD_ERROR_OF_MEAN|10.48||0.1669|TWO_SIDED|90.0|-2.75|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||31.73|-2.75|0.1669
73805690|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.37|STANDARD_ERROR_OF_MEAN|10.92||0.0093|TWO_SIDED|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||46.34|10.40|0.0093
73805691|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.04|STANDARD_ERROR_OF_MEAN|10.64||0.0596|TWO_SIDED|90.0|2.53|37.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||37.55|2.53|0.0596
73805692|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.73|STANDARD_ERROR_OF_MEAN|11.07||0.0017|TWO_SIDED|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||52.96|16.51|0.0017
73805693|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.52|STANDARD_ERROR_OF_MEAN|11.04||0.0097|TWO_SIDED|90.0|10.36|46.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||46.69|10.36|0.0097
73805694|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.97|STANDARD_ERROR_OF_MEAN|11.11||0.0016|TWO_SIDED|90.0|16.68|53.26||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||53.26|16.68|0.0016
73805695|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.6|STANDARD_ERROR_OF_MEAN|11.13||0.0102|TWO_SIDED|90.0|10.28|46.91||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||46.91|10.28|0.0102
73805696|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.73|STANDARD_ERROR_OF_MEAN|11.07||0.0017|TWO_SIDED|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||52.96|16.51|0.0017
73805697|NCT01164579|147160199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.97|STANDARD_ERROR_OF_MEAN|11.07||0.0381|TWO_SIDED|90.0|4.74|41.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||41.19|4.74|0.0381
73805698|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.77|STANDARD_ERROR_OF_MEAN|7.67||0.0959|TWO_SIDED|90.0|0.15|25.4||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||25.40|0.15|0.0959
73805699|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|5.4||0.9544|TWO_SIDED|90.0|-8.58|9.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||9.19|-8.58|0.9544
73805700|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.18|STANDARD_ERROR_OF_MEAN|9.34||0.0036|TWO_SIDED|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.55|11.81|0.0036
73805701|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.55|STANDARD_ERROR_OF_MEAN|7.66||0.264|TWO_SIDED|90.0|-4.04|21.16||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||21.16|-4.04|0.2640
73895522|NCT01578850|147324500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.049|TWO_SIDED|95.0|-4.19|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 28||-0.01|-4.19|0.049
73805702|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||34.95|2.72|0.0544
73805703|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|8.92||0.329|TWO_SIDED|90.0|-5.96|23.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||23.38|-5.96|0.3290
73805704|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.84|STANDARD_ERROR_OF_MEAN|10.48||0.0032|TWO_SIDED|90.0|13.59|48.09||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||48.09|13.59|0.0032
73805705|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.11|STANDARD_ERROR_OF_MEAN|9.92||0.0845|TWO_SIDED|90.0|0.79|33.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||33.43|0.79|0.0845
73805706|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.08|STANDARD_ERROR_OF_MEAN|10.72||0.0037|TWO_SIDED|90.0|13.44|48.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||48.72|13.44|0.0037
73805707|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.96|STANDARD_ERROR_OF_MEAN|10.36||0.054|TWO_SIDED|90.0|2.91|37.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||37.02|2.91|0.0540
73805708|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.54|STANDARD_ERROR_OF_MEAN|10.24||0.001|TWO_SIDED|90.0|16.7|50.39||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||50.39|16.70|0.0010
73805709|NCT01164579|147160200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.81|STANDARD_ERROR_OF_MEAN|9.66||0.0401|TWO_SIDED|90.0|3.92|35.71||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||35.71|3.92|0.0401
73805710|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.91|STANDARD_ERROR_OF_MEAN|10.99||0.0005|TWO_SIDED|90.0|19.83|55.99||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||55.99|19.83|0.0005
73805711|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.12|STANDARD_ERROR_OF_MEAN|11.09||0.0028|TWO_SIDED|90.0|14.87|51.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||51.38|14.87|0.0028
73805712|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.83|STANDARD_ERROR_OF_MEAN|10.1||0.0105|TWO_SIDED|90.0|9.21|42.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.45|9.21|0.0105
73805713|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|STANDARD_ERROR_OF_MEAN|11.13||0.37|TWO_SIDED|90.0|-8.33|28.3||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||28.30|-8.33|0.3700
73805714|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.82|STANDARD_ERROR_OF_MEAN|9.54|<|0.0001|TWO_SIDED|90.0|24.11|55.53||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||55.53|24.11|<0.0001
73805715|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.09|STANDARD_ERROR_OF_MEAN|11.24||0.1076|TWO_SIDED|90.0|-0.4|36.59||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||36.59|-0.40|0.1076
73805716|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.94|STANDARD_ERROR_OF_MEAN|10.21||0.0008|TWO_SIDED|90.0|17.13|50.75||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||50.75|17.13|0.0008
73805717|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.42|STANDARD_ERROR_OF_MEAN|10.74||0.0139|TWO_SIDED|90.0|8.74|44.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||44.10|8.74|0.0139
73805718|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.4|STANDARD_ERROR_OF_MEAN|10.48||0.0005|TWO_SIDED|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||53.64|19.16|0.0005
73805719|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.27|STANDARD_ERROR_OF_MEAN|11.08||0.0177|TWO_SIDED|90.0|8.04|44.5|||Normal approximation to the binomial|||Month 9||44.50|8.04|0.0177
73805720|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.46|STANDARD_ERROR_OF_MEAN|10.73||0.0018|TWO_SIDED|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||51.12|15.80|0.0018
73805721|NCT01164579|147160201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.49|STANDARD_ERROR_OF_MEAN|11.22||0.0363|TWO_SIDED|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||41.96|5.02|0.0363
73805722|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.88|STANDARD_ERROR_OF_MEAN|7.42||0.016|TWO_SIDED|90.0|5.66|30.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||30.10|5.66|0.0160
73805723|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|STANDARD_ERROR_OF_MEAN|5.43||0.2798|TWO_SIDED|90.0|-3.06|14.8||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||14.80|-3.06|0.2798
73805724|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.18|STANDARD_ERROR_OF_MEAN|9.34||0.0036|TWO_SIDED|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.55|11.81|0.0036
73805725|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.78|STANDARD_ERROR_OF_MEAN|7.3||0.4287|TWO_SIDED|90.0|-6.23|17.79||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||17.79|-6.23|0.4287
73805726|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||34.95|2.72|0.0544
73805727|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.04|STANDARD_ERROR_OF_MEAN|9.51||0.0732|TWO_SIDED|90.0|1.39|32.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||32.69|1.39|0.0732
73805728|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.25|STANDARD_ERROR_OF_MEAN|10.61||0.036|TWO_SIDED|90.0|4.79|39.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||39.72|4.79|0.0360
73805729|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.85|STANDARD_ERROR_OF_MEAN|9.85||0.3688|TWO_SIDED|90.0|-7.35|25.07||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||25.07|-7.35|0.3688
73805730|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.19|STANDARD_ERROR_OF_MEAN|10.67||0.0182|TWO_SIDED|90.0|7.63|42.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||42.76|7.63|0.0182
73805731|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|STANDARD_ERROR_OF_MEAN|10.15||0.1558|TWO_SIDED|90.0|-2.29|31.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||31.12|-2.29|0.1558
73805732|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.78|STANDARD_ERROR_OF_MEAN|10.49||0.0012|TWO_SIDED|90.0|16.51|51.05||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||51.05|16.51|0.0012
73895523|NCT01578850|147324500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.38||||0.005|TWO_SIDED|95.0|-5.72|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 36||-1.05|-5.72|0.005
73805733|NCT01164579|147160202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.33|STANDARD_ERROR_OF_MEAN|9.78||0.1426|TWO_SIDED|90.0|-1.74|30.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||30.42|-1.74|0.1426
73805734|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.88|STANDARD_ERROR_OF_MEAN|4.03||0.1449|TWO_SIDED|90.0|-0.75|12.52||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||12.52|-0.75|0.1449
73805735|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|2.81||0.3102|TWO_SIDED|90.0|-1.77|7.48||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||7.48|-1.77|0.3102
73805736|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.94|STANDARD_ERROR_OF_MEAN|7.06||0.0342|TWO_SIDED|90.0|3.32|26.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||26.55|3.32|0.0342
73805737|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|4.65||0.54|TWO_SIDED|90.0|-4.8|10.51||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||10.51|-4.80|0.5400
73805738|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.01|STANDARD_ERROR_OF_MEAN|9.19||0.2759|TWO_SIDED|90.0|-5.1|25.13||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||25.13|-5.10|0.2759
73805739|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|STANDARD_ERROR_OF_MEAN|6.25||0.0859|TWO_SIDED|90.0|-21.02|-0.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||-0.45|-21.02|0.0859
73805740|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.89|STANDARD_ERROR_OF_MEAN|9.62||0.0985|TWO_SIDED|90.0|0.06|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||31.73|0.06|0.0985
73805741|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|8.05||0.9628|TWO_SIDED|90.0|-12.86|13.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||13.61|-12.86|0.9628
73805742|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.07|STANDARD_ERROR_OF_MEAN|10.19||0.0612|TWO_SIDED|90.0|2.31|35.84||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||35.84|2.31|0.0612
73805743|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|8.36||0.7807|TWO_SIDED|90.0|-16.08|11.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||11.43|-16.08|0.7807
73805744|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||34.95|2.72|0.0544
73805745|NCT01164579|147160203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.93|STANDARD_ERROR_OF_MEAN|8.66||0.4937|TWO_SIDED|90.0|-8.32|20.18||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||20.18|-8.32|0.4937
73805746|NCT03491462|147160211|SUPERIORITY|||||||0.6208|||||||Gehan's extended Wilcoxon's test|||||||0.6208
73805747|NCT01050582|147160215|SUPERIORITY_OR_OTHER||Slope|0.447|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|0.22|0.674|||Regression, Linear|Covariates: weight (wt) divided expected wt for age and height (ht), age, use of concomitant medication with growth effects, preexposure ht z-score.|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipychotics.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in current height z-score.||0.674|0.220|<0.001
73805748|NCT01050582|147160216|SUPERIORITY_OR_OTHER||Slope|-0.221|STANDARD_ERROR_OF_MEAN|0.25||0.378|TWO_SIDED|95.0|-0.711|0.269|||Regression, Linear|Covariates: Tanner stage and gender|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipsychotics.|The null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in age (years) at current Tanner stage.||0.269|-0.711|0.378
73805749|NCT01050582|147160217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.865|||>|0.999||95.0|0.189|3.963|||Fisher Exact||Estimated OR is from a logistic regression model including factors for treatment arm, age, indication, and use of concomitant medication with growth effects.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in frequency of retrospectively reported potentially prolactin-related adverse events||3.963|0.189|>0.999
73895524|NCT01578850|147324500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|||<|0.001|TWO_SIDED|95.0|-6.37|-1.67|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 44||-1.67|-6.37|<0.001
73805750|NCT00885664|147160239|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
73805751|NCT00885664|147160240|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73805752|NCT00885664|147160241|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
73805753|NCT00885664|147160242|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
73805754|NCT00885664|147160243|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
73805755|NCT00885664|147160244|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
73805756|NCT00885664|147160245|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73805757|NCT00885664|147160246|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73805758|NCT00885664|147160247|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73805759|NCT00885664|147160248|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
73805760|NCT00885664|147160249|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
73805761|NCT00927862|147160259|NON_INFERIORITY_OR_EQUIVALENCE|Based on power calculations and feasibility, the minimum recruitment target for the randomized, PG-guided comparison was set at 500 patients. All qualifying parallel control patients were included, anticipated to number ≥1000. For hypothesis 1, the power to exclude inferiority of the modified PG arm vs standard PG arm at a margin (delta) of 5% with 250 patients per group at a 2-sided alpha \<0.05 is 87%, assuming a common standard deviation of 0.20.|Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|0.2|<|0.05|TWO_SIDED|95.0||||Comparisons between groups for primary endpoints were made using the unpaired T-test.|t-test, 2 sided|||Comparisons between groups for primary endpoints were made using the unpaired T-test. All consented, randomized patients who were successfully genotyped and received at least one dose of warfarin with at least one post-dose INR were included in efficacy analyses (modified intention to treat \[mITT\]).||||<0.05
73805762|NCT00820248|147160268|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.83|TWO_SIDED|95.0|0.6|1.5|||Regression, Cox||Hazard ratio of panitumumab vs cisplatin|The log rank test stratified by the stratification factors at randomization was used to compare the difference in PFS between two treatment arms.||1.50|0.60|0.83
73805763|NCT00820248|147160269|SUPERIORITY||Cox Proportional Hazard|0.89||||0.66|TWO_SIDED|95.0|0.54|1.48|||Log Rank||hazard ratio for panitumumab vs cisplatin|||1.48|0.54|0.66
73805764|NCT02237196|147160281|SUPERIORITY||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.5038||0.314|TWO_SIDED|95.0|-1.51|0.49|||Longitudinal repeated measures analysis|Model adjusts for Site, Baseline TNSS AUC, and Baseline Cat exposure (low vs high)||||0.49|-1.51|0.314
73805765|NCT03980145|147160296|SUPERIORITY|||||||0.405||||||Statistical significance set at .05|ANOVA|||Null hypothesis is no difference between the two groups||||.405
73805766|NCT03980145|147160296|SUPERIORITY|||||||0.133|||||||ANOVA|||Null hypothesis is no difference between pretest and posttest||||.133
73805767|NCT03980145|147160296|SUPERIORITY|||||||0.05|||||||ANOVA|||Evaluated the difference between the pretest and posttest within the conventional physical therapy group||||.050
73805768|NCT03980145|147160296|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.017|TWO_SIDED|95.0|0.015|0.124||p value was adjusted for multiple comparisons using a Bonferroni correction|ANOVA|||Evaluating the impact of whether comfortable walking speed for both groups combined resulted in a significant improvement in walking speed||.124|.015|.017
73805769|NCT03980145|147160297|SUPERIORITY|||||||0.369|||||||ANOVA|||Comparison of the impact between the two arms looking an improved walking endurance||||.369
73805770|NCT03980145|147160297|SUPERIORITY|||||||0.71|||||||ANOVA|||Evaluation of impact of end-effector robotic training alone||||.710
73805771|NCT03980145|147160297|SUPERIORITY|||||||0.682|||||||ANOVA|||Evaluating the impact of conventional therapy on walking endurance Null hypothesis is no difference between pretest and posttest||||.682
73805772|NCT03980145|147160297|SUPERIORITY|||||||0.568||||||p value adjusted for multiple comparisons - Bonferroni|ANOVA|||Evaluating the impact of whether both groups combined resulted in a significant change in walking distance||||.568
73805773|NCT03980145|147160298|SUPERIORITY|||||||0.594||||||Outcome specific to the physical domain|ANOVA|||Evaluation of the physical domain||||.594
73805774|NCT03980145|147160298|SUPERIORITY|||||||0.061|||||||ANOVA|||Pretest- Posttest End Effector Robotic Training Comparison for the Physical Domain||||.061
73805775|NCT03980145|147160298|SUPERIORITY|||||||0.812|||||||ANOVA|||Pretest posttest comparison of conventional training group for physical domain||||.812
73805776|NCT03980145|147160298|SUPERIORITY|||||||0.235|||||||ANOVA|||Combined conventional and end-effector training for outcomes in the physical domain||||.235
73895525|NCT01578850|147324500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|||<|0.001|TWO_SIDED|95.0|-6.36|-1.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 52||-1.68|-6.36|<0.001
73895526|NCT01578850|147324500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.047|TWO_SIDED|95.0|-4.4|-0.03|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 28||-0.03|-4.40|0.047
73805777|NCT03980145|147160298|SUPERIORITY|||||||0.465|||||||ANOVA|||Between group assessment of changes in the MFIS Cognitive domain||||.465
73805778|NCT03980145|147160298|SUPERIORITY|||||||0.165|||||||ANOVA|||Within group differences for the End Effector Robotic Training Group for the Cognitive Domain||||.165
73805779|NCT03980145|147160298|SUPERIORITY|||||||0.682|||||||ANOVA|||Within group assessment for the conventional group within the cognitive domain of the MFIS||||.682
73805780|NCT03980145|147160298|SUPERIORITY||Mean Difference (Final Values)|5.39||||0.017|TWO_SIDED|95.0|1.12|9.67||p value adjusted using a Bonferroni correction|ANOVA|||Combined group outcomes comparing pretest to posttest for the cognitive domain||9.67|1.12|.017
73805781|NCT03980145|147160298|SUPERIORITY|||||||0.052|||||||ANOVA|||Between group comparison for the MFIS Psychological Subscale||||.052
73805782|NCT03980145|147160298|SUPERIORITY|||||||0.483|||||||ANOVA|||Within group comparison for the end-effector robotic training group for the MFIS Psychological subscale||||.483
73805783|NCT03980145|147160298|SUPERIORITY|||||||0.056|||||||ANOVA|||Within group assessment for the conventional physical therapy group for the MFIS Psychological subscale||||.056
73805784|NCT03980145|147160298|SUPERIORITY||Mean Difference (Final Values)|1.313||||0.048|TWO_SIDED|95.0|0.016|2.619||p value is adjusted for multiple comparisons using a Bonferroni correction|ANOVA|||Change in MFIS for all subjects from pre to posttest for the psychological subscale||2.619|.016|.048
73805785|NCT03980145|147160298|SUPERIORITY|||||||0.01|||||||ANOVA|||Between group assessment of differences in total score||||.010
73805786|NCT03980145|147160298|SUPERIORITY|||||||0.089|||||||ANOVA|||Within assessment of change in total fatigue score||||.089
73805787|NCT03980145|147160298|SUPERIORITY|||||||0.5|||||||ANOVA|||Within group assessment of change in total score||||.50
73805788|NCT03980145|147160298|SUPERIORITY||Mean Difference (Final Values)|9.464||||0.1|TWO_SIDED|95.0|2.678|16.251|||ANOVA|||Combined assessment of all subject improvement in total MFIS score||16.251|2.678|0.10
73805789|NCT03980145|147160299|SUPERIORITY|||||||0.071|||||||ANOVA|||Null hypothesis set for no difference between groups Assessment of between group differences for the physical subscale||||.071
73805790|NCT03980145|147160299|SUPERIORITY||Mean Difference (Final Values)|14.84||||0.005|TWO_SIDED|95.0|6.02|23.66|||ANOVA|||With group assessment of change on the physical subscale of the MSIS||23.66|6.02|.005
73805791|NCT03980145|147160299|SUPERIORITY||Mean Difference (Final Values)|13.57||||0.001|TWO_SIDED|95.0|8.3|18.85|||ANOVA|||With group assessment of change on the physical subscale of the MSIS||18.85|8.30|.001
73805792|NCT03980145|147160299|SUPERIORITY||Mean Difference (Final Values)|14.21||||2.6e-05|TWO_SIDED|95.0|9.367|19.04||p value adjusted for multiple comparisons using Bonferroni|ANOVA|||Combined group assessment of change on the physical subscale of the MSIS||19.04|9.367|.000026
73805793|NCT03980145|147160299|SUPERIORITY|||||||0.084||||||Pretest measures were statistically different between the two groups|ANOVA|||Between group comparison for the psychological subscale for the MSIS||||.084
73805794|NCT03980145|147160299|SUPERIORITY|||||||0.412|||||||ANOVA|||Within group comparison for the psychological subscale for the MSIS||||.412
73805795|NCT03980145|147160299|SUPERIORITY||Mean Difference (Final Values)|22.22||||0.00018|TWO_SIDED|95.0|15.59|28.85|||ANOVA|||Within group comparison for the psychological subscale for the MSIS||28.85|15.59|.00018
73805796|NCT03980145|147160299|SUPERIORITY||Mean Difference (Final Values)|13.19||||0.00049|TWO_SIDED|95.0|7.013|19.38|||ANOVA|||Combined group comparison for the psychological subscale for the MSIS||19.38|7.013|.00049
73805797|NCT03980145|147160300|SUPERIORITY|||||||0.352|||||||ANOVA|||Null hypothesis is no difference between the two groups||||.352
73805798|NCT03980145|147160300|SUPERIORITY|||||||0.079|||||||ANOVA|||Within group assessment||||.079
73805799|NCT03980145|147160300|SUPERIORITY|||||||0.393|||||||ANOVA|||Within group assessment||||.393
73805800|NCT03980145|147160300|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.048|TWO_SIDED|95.0|0.001|0.116|||ANOVA|Adjusted for multiple mean comparisons||Evaluating the impact of whether fast walking speed for both groups combined resulted in a significant improvement in walking speed||.116|.001|.048
73805801|NCT03980145|147160301|SUPERIORITY|||||||0.117|||||||ANOVA|||Between group assessment for the HADS Anxiety Subscale||||.117
73805802|NCT03980145|147160301|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.041|TWO_SIDED|95.0|0.093|3.407|||ANOVA|||Within group assessment for HADS Anxiety Subscale||3.407|.093|.041
73805803|NCT03980145|147160301|SUPERIORITY|||||||0.15|||||||ANOVA|||Within group assessment for HADS Anxiety Subscale||||.150
73805804|NCT03980145|147160301|SUPERIORITY||Mean Difference (Final Values)|1.518||||0.012|TWO_SIDED|95.0|0.39|2.646||p value adjusted for multiple comparisons|ANOVA|||Combined group assessment of HADS Anxiety Subscale||2.646|.390|.012
73805805|NCT03980145|147160302|SUPERIORITY|||||||0.239|||||||ANOVA|||||||.239
73805806|NCT03980145|147160302|SUPERIORITY|||||||0.667|||||||ANOVA|||Comparison between groups for differences in sensory pain score||||.667
73895527|NCT01578850|147324500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54||||0.004|TWO_SIDED|95.0|-5.97|-1.12|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 36||-1.12|-5.97|0.004
73805807|NCT03980145|147160302|SUPERIORITY|||||||0.77|||||||ANOVA|||Between group differences in affective pain||||.770
73805808|NCT03980145|147160303|SUPERIORITY|||||||0.136|||||||ANOVA|||Between group assessment of LLFDI Disability Frequency||||.136
73805809|NCT03980145|147160303|SUPERIORITY|||||||0.833|||||||ANOVA|||Combined group assessment of improvement in LLFDI Disability Frequency||||.833
73805810|NCT03980145|147160303|SUPERIORITY||Mean Difference (Final Values)|6.996||||0.044|TWO_SIDED|95.0|0.212|13.781|||ANOVA|||Between Group Assessment of improvement in LLFDI Disability Limitations||13.781|.212|.044
73805811|NCT03980145|147160303|SUPERIORITY|||||||0.212|||||||ANOVA|||Combined group assessment of improvement in LLFDI Disability Limitations||||.212
73805812|NCT03980145|147160304|SUPERIORITY|||||||0.338|||||||ANOVA|||Between group comparison for the LLDFI Function||||.338
73895528|NCT01578850|147324500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33|||<|0.001|TWO_SIDED|95.0|-6.78|-1.88|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 44||-1.88|-6.78|<0.001
73805813|NCT03980145|147160304|SUPERIORITY||Mean Difference (Final Values)|7.508||||0.007|TWO_SIDED|95.0|2.73|12.28|||ANOVA|||Within group assessment of LLFDI Function||12.28|2.73|.007
73805814|NCT03980145|147160304|SUPERIORITY|||||||0.067|||||||ANOVA|||Within group assessment for changes in LLFDI Function||||.067
73805815|NCT03980145|147160304|SUPERIORITY||Mean Difference (Final Values)|5.99||||0.001|TWO_SIDED|95.0|2.9|9.08||p value adjusted for multiple comparisons|ANOVA|||Combined group improvement in LLFDI Function||9.08|2.90|.001
73805816|NCT01562782|147160330|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups in the primary outcome- the mean fold change in plasma VLDL triglyceride palmitate, 0-4 hours. A power calculation was based on data obtained in 15 overweight subjects. Assuming a mean absolute difference of 2.7 in South Asians and 1.0 in Caucasians and a standard deviation of 2.0 for both, group sample sizes of 16 and 16 were expected to achieve 80% power to detect a difference of 1.7 using a 2-sided Mann-Whitney test.|Mean Difference (Final Values)|0.61||||0.05|TWO_SIDED||||||Mixed Models Analysis|||The equivalence test was used to compare the fold change in plasma VLDL triglyceride palmitate in Caucasians and South Asians.||||0.05
73805817|NCT01562782|147160331|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test was used to compare 1) the fold change in triglycerides in South Asians and Caucasians and 2) the fold change in VLDL triglycerides in South Asians and Caucasians.||||<0.05
73805818|NCT01562782|147160332|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test is used to compare levels after the sugar beverage of 1) glucose at 1 hour 2) lactate at 1 hour 3) NEFA at 2 hours in South Asians vs Caucasians.||||<0.05
73805819|NCT01562782|147160333|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73805820|NCT01562782|147160334|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73805821|NCT01562782|147160335|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||Pearson or Spearman's rank test|||The equivalence test was used to analyze the relationship between the primary outcome, fold change in VLDL TG palmitate, and the listed levels of biomarkers of carbohydrate and fat metabolism. The correlation analysis was performed on data from each study group separately.||||<0.05
73805822|NCT01562782|147160336|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73805823|NCT01562782|147160337|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73805824|NCT01562782|147160338|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73805825|NCT01562782|147160339|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73805826|NCT00863343|147160340|SUPERIORITY_OR_OTHER||Sensitivity|0.82|||||TWO_SIDED|95.0|0.59|0.94|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.94|0.59|
73805827|NCT00863343|147160340|SUPERIORITY_OR_OTHER||Specificity|0.987|||||TWO_SIDED|95.0|0.97|0.99|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.99|0.97|
73805828|NCT00863343|147160341|SUPERIORITY_OR_OTHER||Sensitivity|0.81|||||TWO_SIDED|95.0|0.63|0.92|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.92|0.63|
73805829|NCT00863343|147160341|SUPERIORITY_OR_OTHER||Specificity|0.997|||||TWO_SIDED|95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
73805830|NCT00863343|147160342|SUPERIORITY_OR_OTHER||Sensitivity|0.88|||||TWO_SIDED|95.0|0.7|0.96|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.96|0.70|
73805831|NCT00863343|147160342|SUPERIORITY_OR_OTHER||Specificity|0.997||||||95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
73805832|NCT00863343|147160343|SUPERIORITY_OR_OTHER||Sensitivity|0.79|||||TWO_SIDED|95.0|0.6|0.9|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.90|0.60|
73805833|NCT00863343|147160343|SUPERIORITY_OR_OTHER||Specificity|0.997|||||TWO_SIDED|95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
73895529|NCT01578850|147324500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.27|||<|0.001|TWO_SIDED|95.0|-6.7|-1.84|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 52||-1.84|-6.70|<0.001
73805834|NCT01421225|147160344|EQUIVALENCE|The null hypothesis was that the number of hours would be the same (no effect of control).|Mean Difference (Final Values)|2.2||||0.12|TWO_SIDED|||||Statistical analysis was performed using a paired t-test.|t-test, 2 sided|||We tested the number of nighttime (10 PM - 8 AM) hours glucose was in the target range (110-200 mg/dL) on each of the two nights for which the patient was followed (one night under Standard Insulin Pump Therapy; one night under Closed-loop Insulin Therapy)||||0.12
73805835|NCT00911612|147160348|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Not adjusted since only one comparison was made.|ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for baseline geometric center at 24 hours , BMI, and 7 alpha CHO.||||0.22
73805836|NCT00911612|147160349|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for BMI and 7 alpha HCO.||||0.02
73805837|NCT02049814|147160353|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of 95% CI of Least Square Mean (LS mean) of HbA1C Changes was less than 0.4%, it was considered that the non-inferiority was established.||||||0.0001|||||||Paired t-test|||||||0.0001
73805838|NCT01322490|147160413|SUPERIORITY|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.4742||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.||||||0.4742
73805839|NCT01322490|147160413|SUPERIORITY|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.5885||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.||||||0.5885
73805840|NCT01322490|147160414|SUPERIORITY|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.9588|||||TWO_SIDED|95.0|0.7144|1.2867|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.|||1.2867|0.7144|
73805841|NCT01322490|147160414|SUPERIORITY|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.8941|||||TWO_SIDED|95.0|0.6647|1.2026|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.|||1.2026|0.6647|
73805842|NCT02307279|147160450|SUPERIORITY||Mean Difference (Net)|-2.07|STANDARD_ERROR_OF_MEAN|0.59||0.0007|TWO_SIDED|95.0|-3.24|-0.9|||ANCOVA|Adjusted for stratification factors, and baseline weight|Difference in adjusted mean taken for comparability between the two groups (treatment - placebo)|Simple Superiority, H0: μ (Placebo) -μ (Gelesis100) = 0||-0.90|-3.24|0.0007
73805843|NCT02307279|147160450|SUPERIORITY|||||||0.1193|||||||ANCOVA|Adjusted for stratification factors, and baseline weight||Super-Superiority (\>3% difference), H0: μ(Placebo)-μ(Gelesis100) \< 3%||||0.1193
73805844|NCT02307279|147160451|SUPERIORITY|The performance goal for body weight responders was set at 35%.|||||<|0.0001|||||||Binomial Proportion Test|||H0: π (Gelesis100)\< 0.35||||<0.0001
73805845|NCT02307279|147160451|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0008|TWO_SIDED|95.0|1.34|3.01|||Regression, Logistic|Adjusted for stratification factors and baseline weight||"OR-trt refers to the odds ratio of being a body weight responder for Gelesis100 vs. Placebo.~H0: OR-trt= 1."||3.01|1.34|0.0008
73805846|NCT01342523|147160496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.825|TWO_SIDED|95.0|0.88|1.17||P-value is not adjusted for multiple comparisons.|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving CIS vs No CIS. We hypothesized that CIS would result in significantly higher abstinence rates compared to No CIS.||1.17|0.88|.825
73805847|NCT01342523|147160496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.028|TWO_SIDED|95.0|1.02|1.36||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving NRT vs No NRT. We hypothesized that NRT would result in significantly higher abstinence rates compared to No NRT.||1.36|1.02|.028
73805848|NCT01342523|147160496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.755|TWO_SIDED|95.0|0.85|1.13||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving Email Messaging vs No Email Messaging. We hypothesized that Email Messaging would result in significantly higher abstinence rates compared to No Email Messaging.||1.13|0.85|.755
73805849|NCT01342523|147160496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.057|TWO_SIDED|95.0|0.996|1.33||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full SmokeFree.gov Website vs the Lite SmokeFree.gov Website . We hypothesized that the Full SmokeFree.gov Website would result in significantly higher abstinence rates compared to the LiteSmokeFree.gov Website .||1.33|0.996|.057
73895530|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|-0.2||||0.742|TWO_SIDED|95.0|-4.21|3.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 24||3.90|-4.21|0.742
73805850|NCT01342523|147160496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.555||95.0|0.83|1.11||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full Cessation Booklet vs the Brief Cessation Booklet We hypothesized that the Full Cessation Booklet would result in significantly higher abstinence rates compared to the Brief Cessation Booklet.||1.11|0.83|.555
73805851|NCT01303172|147160527|OTHER||Cox Proportional Hazard|0.54||||0.011|TWO_SIDED|95.0|0.33|0.87|||Log Rank|||The difference between the two treatment groups was tested with a two-sided log-rank test and a Cox regression model was used to estimate the hazard ratio (HR) and its 95% CI and associated p-value.||0.87|0.33|0.011
73805852|NCT04468347|147160535|OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||<0.0001
73805853|NCT04468347|147160535|OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.038||0.0005|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||0.0005
73805854|NCT04468347|147160535|OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.033||0.2161|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||0.2161
73805855|NCT04468347|147160536|OTHER|||||||0.1998|||||||Cochran-Mantel-Haenszel|||||||0.1998
73805856|NCT04468347|147160537|OTHER|||||||0.0646|||||||Cochran-Mantel-Haenszel|||||||0.0646
73805857|NCT00665431|147160538|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority margin (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.94|3.34|||ANCOVA|||||3.34|-5.94|
73805858|NCT00665431|147160539|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-2.11|||||TWO_SIDED|95.0|-6.82|2.6|||ANCOVA|||||2.60|-6.82|
73805859|NCT00665431|147160540|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|3.45|||||TWO_SIDED|95.0|-1.41|8.31|||ANCOVA|||||8.31|-1.41|
73805860|NCT06047366|147160555|OTHER|||||||0.18||||||p \< 0.05 was used as the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.18
73805861|NCT06047366|147160556|OTHER|||||||0.09||||||p \< 0.05 was used as the threshold for statistical significance|Log Rank|||||||0.09
73805862|NCT03483961|147160557|SUPERIORITY|||||||0.0015||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 2 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.0015
73805863|NCT03483961|147160557|SUPERIORITY|||||||0.0761||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 3 vs. Group 1.||Groups 2-8 are compared to Group 1||||0.0761
73805864|NCT03483961|147160557|SUPERIORITY|||||||0.9317||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 4 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.9317
73805865|NCT03483961|147160557|SUPERIORITY||||||<|0.0001||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 5 vs. Group 1.||Groups 2-8 are compared to Group 1.||||<.0001
73805866|NCT03483961|147160557|SUPERIORITY|||||||0.0045||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 6 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.0045
73805867|NCT03483961|147160557|SUPERIORITY|||||||0.1437||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 7 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.1437
73805868|NCT03483961|147160557|SUPERIORITY|||||||0.3216||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 8 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.3216
73805869|NCT01234870|147160565|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality||||<0.001
73805870|NCT01262287|147160586|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
73805871|NCT01262287|147160587|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
73805872|NCT01262287|147160587|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
73805873|NCT01637922|147160598|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|118.12|STANDARD_DEVIATION|15.4||0.1638|TWO_SIDED|90.0|107.06|130.32||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||130.32|107.06|0.1638
73805874|NCT01637922|147160599|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|114.08|STANDARD_DEVIATION|13.2||0.0391|TWO_SIDED|90.0|104.812|124.164||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||124.164|104.812|0.0391
73805875|NCT01637922|147160600|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.79|STANDARD_DEVIATION|18.7||0.0603|TWO_SIDED|90.0|99.243|125.922||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||125.922|99.243|0.0603
73805876|NCT01637922|147160601|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|117.65|STANDARD_DEVIATION|15.0||0.1424|TWO_SIDED|90.0|106.89|129.5||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||129.50|106.89|0.1424
73805877|NCT01637922|147160602|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.46|STANDARD_DEVIATION|16.3||0.0367|TWO_SIDED|90.0|100.42|123.715||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||123.715|100.420|0.0367
73805878|NCT01637922|147160603|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.52|STANDARD_DEVIATION|17.7||0.0488|TWO_SIDED|90.0|99.577|124.888||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||124.888|99.577|0.0488
73895531|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|9.8||||0.143|TWO_SIDED|95.0|2.45|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 28||17.06|2.45|0.143
73895532|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|11.4||||0.111|TWO_SIDED|95.0|3.31|19.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 36||19.51|3.31|0.111
73805879|NCT01637922|147160604|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.01098|||||TWO_SIDED|95.0|-0.189801|0.16864||||||Pearson correlation of trough concentrations of R-methadone and OOWS||0.168640|-0.189801|
73805880|NCT01637922|147160604|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.10188|||||TWO_SIDED|95.0|-0.287471|0.092062||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and OOWS||0.092062|-0.287471|
73805881|NCT01637922|147160604|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.03198|||||TWO_SIDED|95.0|-0.209893|0.148238||||||Pearson correlation of trough concentrations of S-methadone and OOWS||0.148238|-0.209893|
73805882|NCT01637922|147160604|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.0026|||||TWO_SIDED|95.0|-0.189172|0.194156||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and OOWS||0.194156|-0.189172|
73805883|NCT01637922|147160604|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.03364|||||TWO_SIDED|95.0|-0.214505|0.149733||||||Pearson correlation of trough concentrations of Buprenorphine and OOWS||0.149733|-0.214505|
73805884|NCT01637922|147160604|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.14703|||||TWO_SIDED|95.0|-0.404929|0.135425||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and OOWS||0.135425|-0.404929|
73805885|NCT01637922|147160604|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.05431|||||TWO_SIDED|95.0|-0.240578|0.136305||||||Pearson correlation of trough concentrations of norbuprenorphine and OOWS||0.136305|-0.240578|
73805886|NCT01637922|147160604|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.09727|||||TWO_SIDED|95.0|-0.344024|0.163687||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and OOWS||0.163687|-0.344024|
73805887|NCT01637922|147160604|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.36105|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and OOWS||||
73805888|NCT01637922|147160605|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.71|STANDARD_DEVIATION|36.1||0.1642|TWO_SIDED|90.0|85.14|138.8||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||138.80|85.14|0.1642
73805889|NCT01637922|147160606|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|92.43|STANDARD_DEVIATION|33.7||0.142|TWO_SIDED|90.0|73.48|116.27||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||116.27|73.48|0.1420
73895533|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|10.1||||0.175|TWO_SIDED|95.0|1.8|18.49|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 44||18.49|1.80|0.175
73805890|NCT01637922|147160607|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.36|STANDARD_DEVIATION|38.1||0.1915|TWO_SIDED|90.0|81.611|143.883||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||143.883|81.611|0.1915
73805891|NCT01637922|147160608|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.04783|||||TWO_SIDED|95.0|-0.13275|0.224946||||||Pearson correlation of trough concentrations of R-methadone and SOWS||0.224946|-0.132750|
73805892|NCT01637922|147160608|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.39865|||||TWO_SIDED|95.0|-0.547072|-0.222288||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and SOWS||-0.222288|-0.547072|
73805893|NCT01637922|147160608|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.11175|||||TWO_SIDED|95.0|-0.069336|0.284848||||||Pearson correlation of trough concentrations of S-methadone and SOWS||0.284848|-0.069336|
73805894|NCT01637922|147160608|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.16815|||||TWO_SIDED|95.0|-0.34787|0.025107||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and SOWS||0.025107|-0.347870|
73805895|NCT01637922|147160608|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.0126|||||TWO_SIDED|95.0|-0.17016|0.194417||||||Pearson correlation of trough concentrations of Buprenorphine and SOWS||0.194417|-0.170160|
73805896|NCT01637922|147160608|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.02352|||||TWO_SIDED|95.0|-0.253932|0.29696||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and SOWS||0.296960|-0.253932|
73805897|NCT01637922|147160608|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.05787|||||TWO_SIDED|95.0|-0.24392|0.132819||||||Pearson correlation of trough concentrations of norbuprenorphine and SOWS||0.132819|-0.243920|
73805898|NCT01637922|147160608|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.04052|||||TWO_SIDED|95.0|-0.218159|0.293233||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and SOWS||0.293233|-0.218159|
73805899|NCT01637922|147160608|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.92231|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and SOWS||||
73805900|NCT01637922|147160609|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|138.0|STANDARD_DEVIATION|50.7||0.6889|TWO_SIDED|90.0|97.2|195.92||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||195.92|97.20|0.6889
73805901|NCT01637922|147160610|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|132.86|STANDARD_DEVIATION|51.1||0.6188|TWO_SIDED|90.0|93.32|189.16||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||189.16|93.32|0.6188
73805902|NCT01637922|147160611|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|112.03|STANDARD_DEVIATION|52.5||0.3152|TWO_SIDED|90.0|74.85|167.67||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||167.67|74.85|0.3152
73895534|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|10.8||||0.088|TWO_SIDED|95.0|2.49|19.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 52||19.05|2.49|0.088
73805903|NCT01637922|147160612|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|98.94|STANDARD_DEVIATION|19.6||0.0107|TWO_SIDED|90.0|85.81|114.076||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1||114.076|85.810|0.0107
73805904|NCT01637922|147160613|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|94.33|STANDARD_DEVIATION|27.6||0.0738|TWO_SIDED|90.0|78.017|114.054||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1||114.054|78.017|0.0738
73805905|NCT00638404|147160615|OTHER|correlation of anxiety, anticipated pain medication use and anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|anxiety to evoked pain is 0.24 (P\<.001); anticipated pain to evoked pain is 0.33 (P\<.001); anticipated pain medication to evoked pain is 0.33(P\<.001).||||||<.001
73805906|NCT00638404|147160615|OTHER|correlation of anxiety to evoked pain at 24 hour|||||<|0.001|||||||Spearman Correlation|||||||<.001
73805907|NCT00638404|147160615|OTHER|correlation of anticipated pain medication 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|||||||<.001
73805908|NCT00638404|147160615|OTHER|correlation of anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|||||||<.001
73805909|NCT00638404|147160616|OTHER||||||<|0.001|||||||Spearman Correlation|||preoperative questionnaire evaluating anticipated amount of pain medication potentially needed postoperatively; 0= none at all up to 100=as much as possible||||<.001
73805910|NCT00638404|147160617|OTHER||||||<|0.001|||||||Spearman Correlation|||||||<.001
73805911|NCT00638404|147160618|OTHER|Correlation of|||||<|0.001|||||||Spearman Correlation|||||||<.001
73805912|NCT00302848|147160641|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations for VTE risk showed that 50,000 patients should be sufficient to exclude a twofold risk.|Hazard Ratio (HR)|1.0|||<|0.05||95.0|0.6|1.8|||Regression, Cox|||Null hypothesis: HR ≥ 2 (VTE of DRSP vs. LNG)||1.8|0.6|<0.05
73805913|NCT02110758|147160666|OTHER|||||||0.025|||||||Regression, Logistic|||To estimate exposure to the intervention on the Access composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.025
73805914|NCT02110758|147160666|OTHER|||||||0.69|||||||Regression, Logistic|||To estimate exposure to the intervention on the Affective Communication composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||0.69
73805915|NCT02110758|147160666|OTHER|||||||0.013|||||||Regression, Logistic|||To estimate exposure to the intervention on the Shared Decision-Making composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.013
73805916|NCT02110758|147160666|OTHER|||||||0.85|||||||Regression, Logistic|||To estimate exposure to the intervention on the Patient Self-Management composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||0.85
73805917|NCT02110758|147160666|OTHER|||||||0.013|||||||Regression, Logistic|||To estimate exposure to the intervention on the Exchanging Information composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.013
73805918|NCT02110758|147160666|OTHER|||||||0.053|||||||Regression, Logistic|||To estimate exposure to the intervention on the Overall Rating of Treatment Team composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.053
73805919|NCT02110758|147160668|OTHER|||||||0.2|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Hospitalizations, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Hospitalizations. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.2
73805920|NCT02110758|147160668|OTHER|||||||0.62|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Emergency Department (ED) Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month ED Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.62
73805921|NCT02110758|147160668|OTHER|||||||0.68|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Primary Care Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Primary Care Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.68
73805922|NCT02110758|147160668|OTHER|||||||0.03|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Specialist Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Specialist Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.03
73805923|NCT00862823|147160684|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined so there was an 80% chance that a 90% pairwise interval for 2 equivalent formulations would satifsy the FDA criteria for AUC and Cmax of log (0.8), log (1.2).|Geometric Mean Ratio|0.97|||<|0.05||90.0||||Bioequivalent measurew were log-transformed|log transformation|||||||<0.05
73805924|NCT02411396|147160732|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Mean Difference (Final Values)|124.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|118.3|130.9||||||This analysis is to compare outcome measure between ED or IC visits by using time varying propensity score method developed by our group to adjust imbalance of covariates between the two arms. Each patient can have multiple visits to the facility of choice.||130.9|118.3|
73805925|NCT02411396|147160733|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|5.14|||||TWO_SIDED|95.0|4.13|6.41|||||VOC in patients with SCD whom went to EDs represents the numerator, VOC in patients with SCD whom went to ICs represents the denominator for Odds Ratio.|||6.41|4.13|
73805926|NCT02411396|147160734|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|2.24|||||TWO_SIDED|95.0|1.84|2.72|||||VOC in patients with SCD whom went to ICs represents the numerator, VOC in patients with SCD whom went to EDs represents the denominator for Odds Ratio.|||2.72|1.84|
73805927|NCT03660189|147160750|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
73805928|NCT03660189|147160750|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
73805929|NCT03660189|147160752|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73805930|NCT03660189|147160755|SUPERIORITY|||||||0.91|||||||Fisher Exact|||||||0.91
73805931|NCT03660189|147160756|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
73805932|NCT03660189|147160760|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73805933|NCT03660189|147160761|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
73805934|NCT00403481|147160775|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
73805935|NCT00403481|147160776|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 for both daytime and nighttime. No multiplicity adjustments.|one-sample t-test|||||||<0.0001
73805936|NCT00403481|147160777|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||||||<0.0001
73805937|NCT00403481|147160778|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||0.0001
73805938|NCT00403481|147160780|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|||||||<0.0001
73805939|NCT00403481|147160781|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 applies to both the daytime and nighttime analyses|one-sample t-test|||||||<0.0001
73805940|NCT00403481|147160782|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|||||||<0.0001
73805941|NCT00403481|147160783|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 applies to both 4 hour and 6 hour analyses|one-sample t-test|||||||<0.0001
73805942|NCT02099110|147160803|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.46|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.30|-0.63|<0.001
73805943|NCT02099110|147160803|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.43|||<|0.001|TWO_SIDED|95.0|-0.6|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.27|-0.60|<0.001
73805944|NCT02099110|147160803|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.44|||<|0.001|TWO_SIDED|95.0|-0.61|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.27|-0.61|<0.001
73805945|NCT02099110|147160803|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.30|-0.63|<0.001
73805946|NCT02099110|147160804|SUPERIORITY_OR_OTHER||Difference in % vs Ertugliflozin 5 mg|-3.2|||||TWO_SIDED|95.0|-11.7|5.5|||||Based on Miettinen \& Nurminen method.|||5.5|-11.7|
73805947|NCT02099110|147160804|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 15 mg|-1.9|||||TWO_SIDED|95.0|-10.6|6.8|||||Based on Miettinen \& Nurminen method.|||6.8|-10.6|
73805948|NCT02099110|147160804|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|1.4|||||TWO_SIDED|95.0|-7.4|10.1|||||Based on Miettinen \& Nurminen method.|||10.1|-7.4|
73805949|NCT02099110|147160804|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|-1.8|||||TWO_SIDED|95.0|-10.5|7.0|||||Based on Miettinen \& Nurminen method.|||7.0|-10.5|
73805950|NCT02099110|147160805|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 5 mg|0.1|||||TWO_SIDED|95.0|-3.3|3.6|||||Based on Miettinen \& Nurminen method.|||3.6|-3.3|
73805951|NCT02099110|147160805|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 15 mg|0.5|||||TWO_SIDED|95.0|-3.0|4.0|||||Based on Miettinen \& Nurminen method.|||4.0|-3.0|
73805952|NCT02099110|147160805|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|0.5|||||TWO_SIDED|95.0|-2.9|3.9|||||Based on Miettinen \& Nurminen method.|||3.9|-2.9|
73805953|NCT02099110|147160805|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|0.9|||||TWO_SIDED|95.0|-2.5|4.4|||||Based on Miettinen \& Nurminen method.|||4.4|-2.5|
73805954|NCT02099110|147160806|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.85|||<|0.001|TWO_SIDED|95.0|-2.48|-1.22||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-1.22|-2.48|<0.001
73805955|NCT02099110|147160806|SUPERIORITY_OR_OTHER||Difference in the least squares means|-2.27|||<|0.001|TWO_SIDED|95.0|-2.9|-1.64||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained logitudinal data analysis|||||-1.64|-2.90|<0.001
73805956|NCT02099110|147160807|SUPERIORITY_OR_OTHER||Difference in the least squares means|-8.23||||0.004|TWO_SIDED|95.0|-13.82|-2.65||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-2.65|-13.82|0.004
73805957|NCT02099110|147160807|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.79|||<|0.001|TWO_SIDED|95.0|-17.35|-6.23||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-6.23|-17.35|<0.001
73805958|NCT02099110|147160807|SUPERIORITY_OR_OTHER||Difference in the least squares means|-18.4|||<|0.001|TWO_SIDED|95.0|-24.03|-12.77||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-12.77|-24.03|<0.001
73805959|NCT02099110|147160807|SUPERIORITY_OR_OTHER||Difference in the least squares means|-23.14|||<|0.001|TWO_SIDED|95.0|-28.76|-17.53||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-17.53|-28.76|<0.001
73805960|NCT02099110|147160808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14|||<|0.001|TWO_SIDED|95.0|2.68|6.4||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||6.40|2.68|<0.001
73805961|NCT02099110|147160808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53|||<|0.001|TWO_SIDED|95.0|1.68|3.83||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||3.83|1.68|<0.001
73805962|NCT02099110|147160808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.92|4.54||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||4.54|1.92|<0.001
73805963|NCT02099110|147160808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56|||<|0.001|TWO_SIDED|95.0|1.69|3.89|||Regression, Logistic|Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.||||3.89|1.69|<0.001
73805964|NCT02099110|147160809|SUPERIORITY_OR_OTHER||Difference in the least squares means|7.61||||0.155|TWO_SIDED|95.0|-2.9|18.13||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||18.13|-2.90|0.155
73805965|NCT02099110|147160809|SUPERIORITY_OR_OTHER||Difference in the least squares means|-4.87||||0.369|TWO_SIDED|95.0|-15.54|5.8||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||5.80|-15.54|0.369
73805966|NCT02099110|147160809|SUPERIORITY_OR_OTHER||Difference in the least squares means|1.81||||0.734|TWO_SIDED|95.0|-8.66|12.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||12.27|-8.66|0.734
73805967|NCT02099110|147160809|SUPERIORITY_OR_OTHER||Difference in the least squares means|-9.59||||0.075|TWO_SIDED|95.0|-20.17|0.98||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the least squares means|||||0.98|-20.17|0.075
73805968|NCT02099110|147160810|SUPERIORITY_OR_OTHER||Difference in the least squares means|-2.76||||0.005|TWO_SIDED|95.0|-4.69|-0.83||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.83|-4.69|0.005
73805969|NCT02099110|147160810|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.01||||0.002|TWO_SIDED|95.0|-4.94|-1.09||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-1.09|-4.94|0.002
73805970|NCT02064816|147160811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|3.5||0.277763|TWO_SIDED|95.0|-0.46|1.56|||Mann-Whitney Non Parametric test|||||1.56|-0.46|0.277763
73805971|NCT02064816|147160812|SUPERIORITY_OR_OTHER||Least Square (LS) Mean difference|1.3492||||0.0083|TWO_SIDED|95.0|0.3495|2.3489|||linear mixed model for repeated measures|||Week 4||2.3489|0.3495|0.0083
73805972|NCT02064816|147160812|SUPERIORITY_OR_OTHER||LS Mean difference|1.3367||||0.0079|TWO_SIDED|95.0|0.3534|2.32|||linear mixed model for repeated measures|||Week 8||2.3200|0.3534|0.0079
73805973|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|0.4003||||0.4311|TWO_SIDED|95.0|-0.5992|1.3998|||linear mixed model for repeated measures|||ISRs subscale Week 4||1.3998|-0.5992|0.4311
73895535|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|2.5||||0.584|TWO_SIDED|95.0|-4.78|9.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 24||9.75|-4.78|0.584
73895536|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|11.5||||0.226|TWO_SIDED|95.0|1.59|21.34|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 28||21.34|1.59|0.226
73805974|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|0.08479||||0.8635|TWO_SIDED|95.0|-0.885|1.0546|||linear mixed model for repeated measures|||ISRs subscale Week 8||1.0546|-0.8850|0.8635
73805975|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3245||||0.5099|TWO_SIDED|95.0|-1.2927|0.6437|||linear mixed model for repeated measures|||ISRs subscale Week 12||0.6437|-1.2927|0.5099
73805976|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|-0.07079||||0.8574|TWO_SIDED|95.0|-0.8452|0.7036|||linear mixed model for repeated measures|||Global side-effect subscale: Week 4||0.7036|-0.8452|0.8574
73805977|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|0.1897||||0.6338|TWO_SIDED|95.0|-0.5926|0.972|||linear mixed model for repeated measures|||Global side-effect subscale: Week 8||0.9720|-0.5926|0.6338
73805978|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|0.4097||||0.3042|TWO_SIDED|95.0|-0.3734|1.1929|||linear mixed model for repeated measures|||Global side-effect subscale: Week 12||1.1929|-0.3734|0.3042
73805979|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4083||||0.1038|TWO_SIDED|95.0|-0.9008|0.08419|||linear mixed model for repeated measures|||Benefits: Week 4||0.08419|-0.9008|0.1038
73805980|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|-0.1358||||0.594|TWO_SIDED|95.0|-0.637|0.3653|||linear mixed model for repeated measures|||Benefits: Week 8||0.3653|-0.6370|0.5940
73805981|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|-0.05809||||0.8217|TWO_SIDED|95.0|-0.5651|0.4489|||linear mixed model for repeated measures|||Benefits: Week 12||0.4489|-0.5651|0.8217
73805982|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|0.5909||||0.489|TWO_SIDED|95.0|-1.0873|2.269|||linear mixed model for repeated measures|||Description of pain: Week 4||2.2690|-1.0873|0.4890
73805983|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|-0.7689||||0.3719|TWO_SIDED|95.0|-2.4607|0.9229|||linear mixed model for repeated measures|||Description of pain: Week 8||0.9229|-2.4607|0.3719
73805984|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|0.1422||||0.869|TWO_SIDED|95.0|-1.5521|1.8364|||linear mixed model for repeated measures|||Description of pain: Week 12||1.8364|-1.5521|0.8690
73805985|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|0.6544||||0.8328|TWO_SIDED|95.0|-5.4393|6.7482|||linear mixed model for repeated measures|||VAS: Week 4||6.7482|-5.4393|0.8328
73805986|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|-2.2294||||0.4764|TWO_SIDED|95.0|-8.38|3.9212|||linear mixed model for repeated measures|||VAS: Week 8||3.9212|-8.3800|0.4764
73805987|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|-5.4196||||0.0852|TWO_SIDED|95.0|-11.5939|0.7547|||linear mixed model for repeated measures|||VAS: Week 12||0.7547|-11.5939|0.0852
73805988|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|0.006873||||0.9639|TWO_SIDED|95.0|-0.2918|0.3055|||linear mixed model for repeated measures|||Rating of pain: Week 4||0.3055|-0.2918|0.9639
73805989|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|-0.08689||||0.5715|TWO_SIDED|95.0|-0.3886|0.2148|||linear mixed model for repeated measures|||Rating of pain: Week 8||0.2148|-0.3886|0.5715
73805990|NCT02064816|147160813|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2224||||0.1502|TWO_SIDED|95.0|-0.5256|0.0809|||linear mixed model for repeated measures|||Rating of pain: Week 12||0.08090|-0.5256|0.1502
73805991|NCT01732458|147160875|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-16.5|||||TWO_SIDED|95.0|-34.0|2.0||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||2.0|-34.0|
73805992|NCT01732458|147160875|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-4.4|||||TWO_SIDED|95.0|-22.9|14.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||14.3|-22.9|
73805993|NCT01732458|147160875|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-12.4|||||TWO_SIDED|95.0|-30.3|6.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||6.3|-30.3|
73805994|NCT00994461|147160877|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Cochran-Mantel-Haenszel (CMH) test stratified by H. pylori status was employed for the comparison of celecoxib and loxoprofen with placebo. The multiplicity of test was not adjusted because these comparisons were for the secondary objective.|Cochran-Mantel-Haenszel|CMH test stratified by H. pylori status was employed. Continuous correction was used.||Hypothesis testing was conducted with significant p-value level of under 0.05.||||<0.0001
73805995|NCT00570063|147160918|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-1.61|STANDARD_ERROR_OF_MEAN|8.94||0.86|TWO_SIDED|90.0|-16.49|13.27|||Mixed Models Analysis|||P-value and 90 percent confidence interval (CI) were obtained from mixed effects repeated measures analysis using covariance structures spatial power covariance structure (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||13.27|-16.49|0.86
73805996|NCT00570063|147160919|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|2.69||0.65|TWO_SIDED|90.0|-5.71|3.24|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.24|-5.71|0.65
73805997|NCT00570063|147160920|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|2.61||0.93|TWO_SIDED|90.0|-4.59|4.1|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.10|-4.59|0.93
73895537|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|17.2||||0.012|TWO_SIDED|95.0|6.76|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 36||27.56|6.76|0.012
73805998|NCT00570063|147160921|SUPERIORITY_OR_OTHER||LS mean difference|0.74|STANDARD_ERROR_OF_MEAN|4.18||0.86|TWO_SIDED|90.0|-6.21|7.69|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||7.69|-6.21|0.86
73895538|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|19.0||||0.006|TWO_SIDED|95.0|8.59|29.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 44||29.35|8.59|0.006
73895539|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in Proportions|17.7||||0.014|TWO_SIDED|95.0|7.3|28.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 52||28.16|7.30|0.014
73805999|NCT00570063|147160922|SUPERIORITY_OR_OTHER||LS mean difference|-2.57|STANDARD_ERROR_OF_MEAN|3.22||0.43|TWO_SIDED|90.0|-7.92|2.79|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||2.79|-7.92|0.43
73806000|NCT00570063|147160923|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.68||0.91|TWO_SIDED|90.0|-4.76|4.16|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.16|-4.76|0.91
73806001|NCT00570063|147160924|SUPERIORITY_OR_OTHER||LS mean difference|0.63|STANDARD_ERROR_OF_MEAN|2.29||0.78|TWO_SIDED|90.0|-3.17|4.43|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.43|-3.17|0.78
73806002|NCT00570063|147160925|SUPERIORITY_OR_OTHER||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|1.35||0.92|TWO_SIDED|90.0|-2.11|2.39|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||2.39|-2.11|0.92
73895540|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in Proportions|-2.7||||0.702|TWO_SIDED|95.0|-13.49|8.11|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 24||8.11|-13.49|0.702
73895541|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|7.1||||0.378|TWO_SIDED|95.0|-3.37|17.5|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 28||17.50|-3.37|0.378
73806003|NCT00570063|147160926|SUPERIORITY_OR_OTHER||LS mean difference|0.84|STANDARD_ERROR_OF_MEAN|1.62||0.6|TWO_SIDED|90.0|-1.85|3.54|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.54|-1.85|0.60
73806004|NCT00570063|147160927|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|1.86||0.81|TWO_SIDED|90.0|-2.65|3.53|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.53|-2.65|0.81
73806005|NCT00570063|147160928|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.48||0.93|TWO_SIDED|90.0|-0.84|0.76|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||0.76|-0.84|0.93
73806006|NCT00570063|147160929|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.68||0.99|TWO_SIDED|90.0|-1.13|1.14|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects.||1.14|-1.13|0.99
73806007|NCT00570063|147160930|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.158|STANDARD_DEVIATION|0.844|||TWO_SIDED|90.0|-1.546|1.231||||||Change at Day 21: Cried||1.231|-1.546|
73806008|NCT00570063|147160930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.444|STANDARD_DEVIATION|1.078|||TWO_SIDED|90.0|-1.329|2.218||||||Change at Day 21: Felt blue or depressed||2.218|-1.329|
73806009|NCT00570063|147160930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.544|STANDARD_DEVIATION|4.32|||TWO_SIDED|90.0|-5.561|8.649||||||Change at Day 21: Irritability||8.649|-5.561|
73806010|NCT00570063|147160930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.573|STANDARD_DEVIATION|2.955|||TWO_SIDED|90.0|-4.287|5.433||||||Change at Day 21: Manifest psychosis||5.433|-4.287|
73806011|NCT00570063|147160930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.556|STANDARD_DEVIATION|2.096|||TWO_SIDED|90.0|-2.892|4.003||||||Change at Day 21: Personal neatness||4.003|-2.892|
73806012|NCT00570063|147160930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.327|STANDARD_DEVIATION|0.532|||TWO_SIDED|90.0|-1.202|0.547||||||Change at Day 21: Refused to speak||0.547|-1.202|
73806013|NCT00570063|147160930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.632|STANDARD_DEVIATION|2.749|||TWO_SIDED|90.0|-5.152|3.889||||||Change at Day 21: Retardation||3.889|-5.152|
73806014|NCT00570063|147160930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_DEVIATION|0.572|||TWO_SIDED|90.0|-1.11|0.771||||||Change at Day 21: Said he/she was no good||0.771|-1.110|
73806015|NCT00570063|147160930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.561|STANDARD_DEVIATION|2.63|||TWO_SIDED|90.0|-4.887|3.764||||||Change at Day 21: Social competence||3.764|-4.887|
73806016|NCT00570063|147160930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62|STANDARD_DEVIATION|4.447|||TWO_SIDED|90.0|-7.934|6.694||||||Change at Day 21: Social interest||6.694|-7.934|
73806017|NCT00570063|147160931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.712|STANDARD_DEVIATION|12.24|||TWO_SIDED|90.0|-14.42|25.845||||||||25.845|-14.42|
73806018|NCT00570063|147160941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.849|STANDARD_DEVIATION|4.23|||TWO_SIDED|90.0|-7.807|6.109||||||||6.109|-7.807|
73806019|NCT00570063|147160942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.195|STANDARD_DEVIATION|9.307|||TWO_SIDED|90.0|-19.5|11.114||||||||11.114|-19.50|
73806020|NCT00570063|147160943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.273|STANDARD_DEVIATION|3.488|||TWO_SIDED|90.0|-6.01|5.465||||||Change at Day 21: Parkinsonism||5.465|-6.010|
73806021|NCT00570063|147160943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.182|STANDARD_DEVIATION|3.008|||TWO_SIDED|90.0|-5.13|4.766||||||Change at Day 21: Dyskinesia||4.766|-5.130|
73806022|NCT00570063|147160943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.932|STANDARD_DEVIATION|1.425|||TWO_SIDED|90.0|-3.275|1.411||||||Change at Day 21: Dystonia||1.411|-3.275|
73806023|NCT00570063|147160943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.705|STANDARD_DEVIATION|1.652|||TWO_SIDED|90.0|-2.013|3.422||||||Change at Day 21: Akathisia||3.422|-2.013|
73806024|NCT00570063|147160944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.291|STANDARD_DEVIATION|1.203|||TWO_SIDED|90.0|-2.27|1.688||||||Change at Day 4||1.688|-2.270|
73806025|NCT00570063|147160944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.327|STANDARD_DEVIATION|1.349|||TWO_SIDED|90.0|-1.892|2.547||||||Change at Day 7||2.547|-1.892|
73806026|NCT00570063|147160944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.436|STANDARD_DEVIATION|1.448|||TWO_SIDED|90.0|-1.946|2.817||||||Change at Day 14||2.817|-1.946|
73806027|NCT00570063|147160944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|1.133|||TWO_SIDED|90.0|-1.763|1.963||||||Change at Day 21||1.963|-1.763|
73806028|NCT03307252|147160949|OTHER||Adjusted geometric mean (gMean) ratio|100.7|STANDARD_ERROR_OF_MEAN|17.9|||TWO_SIDED|90.0|88.84|114.15|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|114.15|88.84|
73806029|NCT03307252|147160949|OTHER||Adjusted gMean ratio|93.76|STANDARD_ERROR_OF_MEAN|12.1|||TWO_SIDED|90.0|86.12|102.06|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|102.06|86.12|
73806030|NCT03307252|147160949|OTHER||Adjusted gMean Ratio|82.97|STANDARD_ERROR_OF_MEAN|10.7|||TWO_SIDED|90.0|76.96|89.46|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|89.46|76.96|
73806031|NCT03307252|147160949|OTHER||Adjusted gMean Ratio|113.4|STANDARD_ERROR_OF_MEAN|21.5|||TWO_SIDED|90.0|97.62|131.72|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|131.72|97.62|
73806032|NCT03307252|147160950|OTHER||Adjusted geometric mean (gMean) ratio|131.41|STANDARD_ERROR_OF_MEAN|17.9|||TWO_SIDED|90.0|115.93|148.97|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|148.97|115.93|
73806033|NCT03307252|147160950|OTHER||Adjusted gMean ratio|119.78|STANDARD_ERROR_OF_MEAN|12.1|||TWO_SIDED|90.0|110.03|130.39|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|130.39|110.03|
73806034|NCT03307252|147160950|OTHER||Adjusted gMean Ratio|108.55|STANDARD_ERROR_OF_MEAN|10.7|||TWO_SIDED|90.0|100.68|117.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|117.03|100.68|
73806035|NCT03307252|147160950|OTHER||Adjusted gMean Ratio|348.06|STANDARD_ERROR_OF_MEAN|21.5|||TWO_SIDED|90.0|299.64|404.31|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|404.31|299.64|
73806036|NCT03307252|147160951|OTHER||Adjusted geometric mean (gMean) ratio|125.61|STANDARD_ERROR_OF_MEAN|13.2|||TWO_SIDED|90.0|113.99|138.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|138.43|113.99|
73806037|NCT03307252|147160951|OTHER||Adjusted gMean ratio|101.21|STANDARD_ERROR_OF_MEAN|9.2|||TWO_SIDED|90.0|94.59|108.3|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|108.30|94.59|
73806038|NCT03307252|147160951|OTHER||Adjusted gMean Ratio|130.94|STANDARD_ERROR_OF_MEAN|13.6|||TWO_SIDED|90.0|119.82|143.1|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|143.10|119.82|
73806039|NCT03307252|147160951|OTHER||Adjusted gMean Ratio|107.42|STANDARD_ERROR_OF_MEAN|12.9|||TWO_SIDED|90.0|97.57|118.27|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|118.27|97.57|
73806040|NCT03307252|147160952|OTHER||Adjusted geometric mean (gMean) ratio|106.78|STANDARD_ERROR_OF_MEAN|15.5|||TWO_SIDED|90.0|96.51|118.15|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|118.15|96.51|
73806041|NCT03307252|147160952|OTHER||Adjusted gMean ratio|271.63|STANDARD_ERROR_OF_MEAN|15.9|||TWO_SIDED|90.0|246.74|299.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|299.03|246.74|
73895542|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|17.3||||0.004|TWO_SIDED|95.0|7.12|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 36||27.56|7.12|0.004
73806042|NCT03307252|147160952|OTHER||Adjusted gMean Ratio|100.8|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|90.0|94.62|107.39|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|107.39|94.62|
73806043|NCT03307252|147160952|OTHER||Adjusted gMean Ratio|223.24|STANDARD_ERROR_OF_MEAN|13.9|||TWO_SIDED|90.0|203.79|244.55|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|244.55|203.79|
73806044|NCT03307252|147160953|OTHER||Adjusted geometric mean (gMean) ratio|121.64|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|100.43|147.33|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|147.33|100.43|
73806045|NCT03307252|147160953|OTHER||Adjusted gMean ratio|95.18|STANDARD_ERROR_OF_MEAN|19.6|||TWO_SIDED|90.0|83.03|109.11|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|109.11|83.03|
73806046|NCT03307252|147160953|OTHER||Adjusted gMean Ratio|80.19|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|73.01|88.08|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|88.08|73.01|
73806047|NCT03307252|147160953|OTHER||Adjusted gMean Ratio|115.39|STANDARD_ERROR_OF_MEAN|30.1|||TWO_SIDED|90.0|93.8|141.94|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|141.94|93.80|
73806048|NCT03307252|147160954|OTHER||Adjusted geometric mean (gMean) ratio|218.26|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|180.19|264.36|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|264.36|180.19|
73806049|NCT03307252|147160954|OTHER||Adjusted gMean ratio|135.07|STANDARD_ERROR_OF_MEAN|19.6|||TWO_SIDED|90.0|117.83|154.84|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|154.84|117.83|
73806050|NCT03307252|147160954|OTHER||Adjusted gMean Ratio|112.31|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|102.26|123.35|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|123.35|102.26|
73806051|NCT03307252|147160954|OTHER||Adjusted gMean Ratio|1125.1|STANDARD_ERROR_OF_MEAN|30.1|||TWO_SIDED|90.0|914.63|1384.0|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|1384.00|914.63|
73806052|NCT03307252|147160955|OTHER||Adjusted geometric mean (gMean) ratio|218.26|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|180.19|264.36|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|264.36|180.19|
73806053|NCT03307252|147160955|OTHER||Adjusted gMean ratio|104.78|STANDARD_ERROR_OF_MEAN|21.0|||TWO_SIDED|90.0|89.97|122.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|122.03|89.97|
73806054|NCT03307252|147160955|OTHER||Adjusted gMean Ratio|122.65|STANDARD_ERROR_OF_MEAN|20.1|||TWO_SIDED|90.0|107.68|139.69|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|139.69|107.68|
73895543|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|18.5||||0.001|TWO_SIDED|95.0|8.4|28.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 44||28.55|8.40|0.001
73806055|NCT03307252|147160955|OTHER||Adjusted gMean Ratio|116.88|STANDARD_ERROR_OF_MEAN|14.4|||TWO_SIDED|90.0|105.07|130.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|130.03|105.07|
73806056|NCT03307252|147160956|OTHER||Adjusted geometric mean (gMean) ratio|87.07|STANDARD_ERROR_OF_MEAN|20.9|||TWO_SIDED|90.0|76.08|99.64|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|99.64|76.08|
73806057|NCT03307252|147160956|OTHER||Adjusted gMean ratio|122.94|STANDARD_ERROR_OF_MEAN|18.0|||TWO_SIDED|90.0|110.25|137.09|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|137.09|110.25|
73806058|NCT03307252|147160956|OTHER||Adjusted gMean Ratio|101.35|STANDARD_ERROR_OF_MEAN|12.0|||TWO_SIDED|90.0|93.65|109.7|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|109.70|93.65|
73806059|NCT03307252|147160956|OTHER||Adjusted gMean Ratio|428.23|STANDARD_ERROR_OF_MEAN|26.8|||TWO_SIDED|90.0|359.78|509.7|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|509.70|359.78|
73806060|NCT03307252|147160957|OTHER||Adjusted gMean ratio|92.24|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|90.0|85.28|99.76|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|99.76|85.28|
73806061|NCT03307252|147160957|OTHER||Adjusted gMean Ratio|83.99|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|78.32|90.08|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|90.08|78.32|
73806062|NCT03307252|147160957|OTHER||Adjusted gMean Ratio|124.06|STANDARD_ERROR_OF_MEAN|23.9|||TWO_SIDED|90.0|105.11|146.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|146.43|105.11|
73806063|NCT03307252|147160958|OTHER||Adjusted gMean Ratio|112.73|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|90.0|104.23|121.92|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|121.92|104.23|
73806064|NCT03307252|147160958|OTHER||Adjusted gMean Ratio|108.56|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|101.22|116.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|116.43|101.22|
73806065|NCT03307252|147160958|OTHER||Adjusted gMean Ratio|340.67|STANDARD_ERROR_OF_MEAN|23.9|||TWO_SIDED|90.0|288.63|402.1|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|402.10|288.63|
73806066|NCT03307252|147160959|OTHER||Adjusted gMean ratio|100.78|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|93.59|108.51|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|108.51|93.59|
73895544|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|16.0||||0.005|TWO_SIDED|95.0|5.96|26.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 52||26.02|5.96|0.005
73806067|NCT03307252|147160959|OTHER||Adjusted gMean Ratio|131.37|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|120.37|143.37|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|143.37|120.37|
73806068|NCT03307252|147160959|OTHER||Adjusted gMean Ratio|106.55|STANDARD_ERROR_OF_MEAN|12.8|||TWO_SIDED|90.0|96.87|117.19|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|117.19|96.87|
73806069|NCT03307252|147160960|OTHER||Adjusted gMean ratio|260.11|STANDARD_ERROR_OF_MEAN|14.7|||TWO_SIDED|90.0|237.96|284.32|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|284.32|237.96|
73806070|NCT03307252|147160960|OTHER||Adjusted gMean Ratio|101.21|STANDARD_ERROR_OF_MEAN|9.4|||TWO_SIDED|90.0|95.15|107.66|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|107.66|95.15|
73806071|NCT03307252|147160960|OTHER||Adjusted gMean Ratio|215.28|STANDARD_ERROR_OF_MEAN|13.1|||TWO_SIDED|90.0|197.53|234.63|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|234.63|197.53|
73806072|NCT03482453|147160965|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least square means (LS means) for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) Confidence Intervals (CIs) of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.881|||||TWO_SIDED|90.0|0.7108|1.0921||||||||1.0921|0.7108|
73806073|NCT03482453|147160965|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9637|||||TWO_SIDED|90.0|0.8361|1.1107||||||||1.1107|0.8361|
73806074|NCT03482453|147160966|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9317|||||TWO_SIDED|90.0|0.8458|1.0263||||||||1.0263|0.8458|
73806075|NCT03482453|147160971|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|1.0153|||||TWO_SIDED|90.0|0.8977|1.1483||||||||1.1483|0.8977|
73806076|NCT03482453|147160971|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9506|||||TWO_SIDED|90.0|0.874|1.0339||||||||1.0339|0.8740|
73806077|NCT03482453|147160972|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9603|||||TWO_SIDED|90.0|0.8861|1.0408||||||||1.0408|0.8861|
73806078|NCT02157376|147160995|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the two-sided 95% confidence interval for the difference is larger than -0.05, the non-inferiority claim will be met.|Risk Difference (RD)|1.9||||0.393|TWO_SIDED|95.0|-2.8|6.5|||Pearson's Chi-square||The difference in treatment group percentages is given by Cimetidine minus Esomeprazole.|Assuming a bleeding percent of 6.3% for the active comparator, a risk reduction of 3.7% for esomeprazole, and a 5% non-inferiority margin, 150 patients per treatment arm will provide 94% power to demonstrate non-inferiority. The null hypothesis is that the bleeding rate for iv esomeprazole 40 mg bid exceeds the rate for iv cimetidine by an amount at least as large as 5%.||6.5|-2.8|0.393
73806079|NCT01578239|147161014|SUPERIORITY||Hazard Ratio (HR)|0.177|||<|0.0001|TWO_SIDED|95.0|0.108|0.289||Derived from a two-sided test between the two groups|Log Rank||Hazard ratio is expressed as Lu-DOTA-Tyr-Octreotate / Octreotide LAR and estimated from the corresponding Cox model.|||0.289|0.108|<0.0001
73806080|NCT01578239|147161015|SUPERIORITY|||||||0.0141|||||||Fisher Exact|||||||0.0141
73806081|NCT01578239|147161016|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3039|TWO_SIDED|95.0|0.6|1.17|||Log Rank|||||1.17|0.60|0.3039
73806082|NCT01578239|147161017|SUPERIORITY||Cox Proportional Hazard|0.84||||0.3039|TWO_SIDED|95.0|0.6|1.17|||Log Rank||Hazard Ratio of Lu-DOTA-Tyr-Octreotate vs. Octreotide LAR|||1.17|0.60|0.3039
73806083|NCT01578239|147161018|SUPERIORITY||Hazard Ratio (HR)|0.137|||<|0.0001|TWO_SIDED|95.0|0.077|0.242|||Log Rank|||||0.242|0.077|<0.0001
73806084|NCT02347813|147161029|OTHER||Mean Difference (Final Values)|0.5||||0.75|TWO_SIDED|95.0|||||ANOVA|||||||0.750
73806085|NCT01385137|147161034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.58|TWO_SIDED|95.0|-0.79|0.44|||Regression, Linear|||||0.44|-0.79|0.58
73806086|NCT01385137|147161036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.42|TWO_SIDED|95.0|-7.3|3.04|||Regression, Linear|||||3.04|-7.30|0.42
73806087|NCT01385137|147161037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.77|TWO_SIDED|95.0|-4.17|5.6|||Regression, Linear|||||5.60|-4.17|0.77
73806088|NCT01385137|147161038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||0.21|TWO_SIDED|95.0|-1.16|5.44|||Regression, Linear|||||5.44|-1.16|0.21
73806089|NCT02837731|147161039|SUPERIORITY||Mean Difference (Final Values)|-1.37||||0.021|TWO_SIDED|95.0|-2.53|0.21|||t-test, 2 sided|||||0.21|-2.53|0.021
73806090|NCT02837731|147161040|OTHER||Mean Difference (Final Values)|-0.124||||0.042|TWO_SIDED|95.0|-0.27|-0.01|||Fisher Exact||Converted Estimated Value of -12.4% to decimal value of -0.124.|||-0.01|-0.27|0.042
73806091|NCT02837731|147161041|OTHER||Mean Difference (Final Values)|-0.1642||||0.044|TWO_SIDED|95.0|-0.33|0.0|||Chi-squared||Converted Estimated Value of -16.42% to decimal value of -0.1642.|||0|-0.33|0.044
73806092|NCT02837731|147161042|OTHER||Mean Difference (Final Values)|-2.91||||0.113|TWO_SIDED|95.0|-6.67|0.85|||Fisher Exact|||||0.85|-6.67|0.113
73806093|NCT02837731|147161043|OTHER||Mean Difference (Final Values)|-72.43|||||TWO_SIDED|95.0|-154.08|9.22|||Wilcoxon (Mann-Whitney)|||||9.22|-154.08|
73806094|NCT02837731|147161044|OTHER||Mean Difference (Final Values)|-14.91||||0.426|TWO_SIDED|95.0|-52.5|22.68|||Wilcoxon (Mann-Whitney)|||||22.68|-52.50|0.426
73806095|NCT02837731|147161045|OTHER||Mean Difference (Final Values)|0.09||||0.453|TWO_SIDED|95.0|-0.34|0.52|||ANCOVA|||||0.52|-0.34|0.453
73806096|NCT03771560|147161094|OTHER||Mean Difference (Final Values)|-2.4||||0.56|TWO_SIDED|95.0|-11.3|6.4|||Paired Sample t-test|||The parent-reported change in mean ABC total score from baseline to week 12.||6.4|-11.3|0.56
73806097|NCT03771560|147161095|OTHER||Mean Difference (Final Values)|1.2||||0.68|TWO_SIDED|95.0|-5.2|7.6|||Paired Sample t-test|||The teacher-reported change in mean ABC total score from baseline to week 12.||7.6|-5.2|0.68
73806098|NCT03771560|147161096|OTHER||Mean Difference (Final Values)|-7.8||||0.095|TWO_SIDED|95.0|-17.3|1.6|||Paired Sample t-test|||The parent-reported change in mean SRS total score from baseline to week 12.||1.6|-17.3|0.095
73806099|NCT03771560|147161097|OTHER||Median Difference (Final Values)|-0.5||||0.95|TWO_SIDED|95.0|-7.0|13.5|||Wilcoxon (Mann-Whitney)|||The teacher-reported change in mean SRS total score from baseline to week 12.||13.5|-7.0|0.95
73806100|NCT03771560|147161098|OTHER||Mean Difference (Final Values)|-0.8||||0.69|TWO_SIDED|95.0|-5.2|3.5|||Paired Sample t-test|||The parent-reported change in mean PedsQL total score from baseline to week 12.||3.5|-5.2|0.69
73806101|NCT02887183|147161099|OTHER||Least Squared Geometric Mean Ratio|0.632|||<|0.0001|TWO_SIDED|95.0|0.5865|0.681|||ANCOVA|||||0.6810|0.5865|<.0001
73806102|NCT02887183|147161100|OTHER||Least Squared Mean|-7.57|||<|0.0001|TWO_SIDED|95.0|-7.98|-7.15|||ANCOVA|||LAVi||-7.15|-7.98|<.0001
73806103|NCT02887183|147161100|OTHER||Least Squared Mean|-12.25|||<|0.0001|TWO_SIDED|95.0|-12.92|-11.58|||ANCOVA|||LVEDVi||-11.58|-12.92|<.0001
73806104|NCT02887183|147161100|OTHER||Least Squared Mean|-15.29|||<|0.0001|TWO_SIDED|95.0|-16.03|-14.55|||ANCOVA|||LVESVi||-14.55|-16.03|<.0001
73806105|NCT02887183|147161101|OTHER||Least Squared Mean|9.37|||<|0.001|TWO_SIDED|95.0|8.84|9.9|||ANCOVA|||||9.90|8.84|<.001
73806106|NCT02887183|147161102|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF||||<.0001
73806107|NCT02887183|147161103|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF||||<.0001
73806108|NCT02887183|147161104|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||<.0001
73806109|NCT02887183|147161104|OTHER|Pearson's Correlation||||||0.0003|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0003
73806110|NCT02887183|147161104|OTHER|Pearson's Correlation||||||0.0956|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0956
73806111|NCT02887183|147161105|OTHER|Pearson's Correlation||||||0.006|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.0060
73806112|NCT02887183|147161105|OTHER|Pearson's Correlation||||||0.0012|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0012
73806113|NCT02887183|147161105|OTHER|Pearson's Correlation||||||0.0181|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0181
73806114|NCT02887183|147161106|OTHER|Pearson's Correlation||||||0.2498|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.2498
73806115|NCT02887183|147161106|OTHER|Pearson's Correlation||||||0.0495|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0495
73806116|NCT02887183|147161106|OTHER|Pearson's Correlation||||||0.2685|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.2685
73806117|NCT02887183|147161107|OTHER|Pearson's Correlation||||||0.0029|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.0029
73806118|NCT02887183|147161107|OTHER|Pearson's Correlation||||||0.0011|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0011
73806119|NCT02887183|147161107|OTHER|Pearson's Correlation||||||0.0012|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0012
73806120|NCT02887183|147161108|OTHER||Least Squared Mean|9.32|||<|0.0001|TWO_SIDED|95.0|7.94|10.69|||ANCOVA|||||10.69|7.94|<.0001
73806121|NCT01031680|147161109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.0473|<|0.0001|TWO_SIDED|95.0|-0.56|-0.37||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.37|-0.56|<0.0001
73806122|NCT01031680|147161110|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.9|||<|0.0001|TWO_SIDED|95.0|7.0|12.9||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||12.9|7.0|<0.0001
73806123|NCT01031680|147161111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.7898||0.0126|TWO_SIDED|95.0|-3.52|-0.42||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.42|-3.52|0.0126
73806124|NCT01031680|147161112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.27|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001||95.0|-2.64|-1.89||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.89|-2.64|<0.0001
73806125|NCT01031680|147161113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.8203||0.0174|TWO_SIDED|95.0|-3.56|-0.34||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.34|-3.56|0.0174
73806126|NCT01031680|147161114|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|2.126|<|0.0001|TWO_SIDED|95.0|8.3|16.6||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum (gender)||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||16.6|8.3|<0.0001
73806127|NCT01921101|147161129|SUPERIORITY_OR_OTHER|||||||0.29|||||||Chi-squared|||||||0.29
73806128|NCT01483027|147161134|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0013|TWO_SIDED|95.0|0.54|0.88|||Log Rank|||Analysis performed using a log-rank test||0.88|0.54|0.0013
73806129|NCT01483027|147161135|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.77|||Log Rank|||Analysis performed using a log-rank test.||0.77|0.46|<0.0001
73806130|NCT01605552|147161167|SUPERIORITY|||||||0.21|||||||ANCOVA||||Cohen's d = 0.61|||.21
73806131|NCT01605552|147161168|SUPERIORITY|||||||0.019|||||||ANCOVA||||Cohen's d = 1.33|||.019
73806132|NCT01605552|147161169|SUPERIORITY|||||||0.09|||||||ANCOVA||||Cohen's d = 0.78|||.09
73806133|NCT01605552|147161170|SUPERIORITY|||||||0.43|||||||ANCOVA||||Cohen's d = 0.43|||.43
73806134|NCT00648115|147161171|SUPERIORITY_OR_OTHER||Pearson chi square|7.3|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
73806135|NCT03018080|147161173|OTHER|Estimation only.|Rate|0.238|||||TWO_SIDED|95.0|0.082|0.472|||||Confidence interval estimated using the Clopper Pearson method.|The reported grade 3/4 toxicity rate with weekly paclitaxel was 0.35. If it became evident that the grade 3/4 treatment-related toxicity rate on either arm convincingly exceeded 0.35, the study arm would have been halted. Convincing evidence of exceeding 0.35 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.50 or higher.||0.472|0.082|
73806136|NCT03018080|147161173|OTHER|Estimation only.|Rate|0.316|||||TWO_SIDED|95.0|0.126|0.566|||||Confidence interval estimated using the Clopper Pearson method.|The reported grade 3/4 toxicity rate with weekly paclitaxel was 0.35. If it became evident that the grade 3/4 treatment-related toxicity rate on either arm convincingly exceeded 0.35, the study arm would have been halted. Convincing evidence of exceeding 0.35 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.50 or higher.||0.566|0.126|
73806137|NCT03018080|147161174|OTHER|Estimation only|Rate|0.191|||||TWO_SIDED|95.0|0.055|0.419|||||Confidence interval estimated using the Clopper Pearson method.|||0.419|0.055|
73806138|NCT03018080|147161174|OTHER|Estimation only.|Rate|0.421|||||TWO_SIDED|95.0|0.203|0.665|||||Confidence interval estimated using the Clopper Pearson method|||0.665|0.203|
73806139|NCT03018080|147161175|OTHER|Estimation only|Median|4.1|||||TWO_SIDED|95.0|1.4|6.9|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||6.9|1.4|
73806140|NCT03018080|147161175|OTHER|Estimation only|Median|3.9|||||TWO_SIDED|95.0|1.4|6.8|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||6.8|1.4|
73806141|NCT03018080|147161176|OTHER|Estimation only|Median|27.6|||||TWO_SIDED|95.0|9.7||Upper limit of the confidence interval is not reached due to censoring rate||||The Kaplan Meier method was used to estimate median OS (in months). The Greenwood method was used to estimate confidence limits of median overall survival.||||9.7|
73806142|NCT03018080|147161176|OTHER|Estimation only|Median|9.0|||||TWO_SIDED|95.0|6.8|14.0|||||The Kaplan Meier method was used to estimate median OS (in months). The Greenwood method was used to estimate confidence limits of median overall survival.|||14.0|6.8|
73806143|NCT03018080|147161177|OTHER|Estimation only.|Rate|0.667|||||TWO_SIDED|95.0|0.43|0.854|||||Confidence interval estimated using the Clopper Pearson method|||0.854|0.430|
73806144|NCT03018080|147161177|OTHER|Estimation only|Rate|0.632|||||TWO_SIDED|95.0|0.384|0.837|||||Confidence interval estimated using the Clopper Pearson method|||0.837|0.384|
73806145|NCT03018080|147161178|OTHER|Estimation only|Median|7.3|||||TWO_SIDED|95.0|5.6|8.3|||||"The Kaplan Meier method was used to estimate median duration of response (in months).~The Greenwood method was used to estimate confidence limits of median duration of response."|||8.3|5.6|
73806146|NCT03018080|147161178|OTHER|Estimation only|Median|4.0|||||TWO_SIDED|95.0|2.6|8.3|||||"The Kaplan Meier method was used to estimate median duration of response (in months).~The Greenwood method was used to estimate confidence limits of median duration of response."|||8.3|2.6|
73806147|NCT03935425|147161188|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
73806148|NCT00267969|147161217|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
73806149|NCT00267969|147161217|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for the multiplicity for the primary endpoint analysis, the Holm's procedure was used at an overall significance level of 0.05|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 750 patients (250 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight \[\<=90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.001
73806150|NCT00267969|147161218|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel(CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
73806151|NCT00267969|147161218|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
73806152|NCT00267969|147161219|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||||||<0.001
73806153|NCT00267969|147161219|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
73806154|NCT00267969|147161220|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
73806155|NCT00267969|147161220|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
73806156|NCT00267969|147161220|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between combined maintenance group and the combined withdrawal group, ustekinumab 90 mg maintenance group and the withdrawal group, ustekinumab 45 mg maintenance group and the withdrawal group at an overall significance level of 0.05.||||0.001
73806157|NCT01309360|147161221|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
73806158|NCT01309360|147161221|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
73806159|NCT01309360|147161221|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
73806160|NCT01309360|147161222|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Kruskal-Wallis|||||||0
73806161|NCT01309360|147161223|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||Fisher Exact|||||||0.059
73806162|NCT01309360|147161223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73806163|NCT01309360|147161223|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
73806164|NCT01309360|147161224|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Fisher Exact|||||||0.675
73806165|NCT01309360|147161224|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||Fisher Exact|||||||0.087
73806166|NCT01309360|147161224|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||Fisher Exact|||||||0.348
73806167|NCT01309360|147161225|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.247
73806168|NCT01309360|147161225|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73806169|NCT01309360|147161225|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73806170|NCT01309360|147161226|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
73806171|NCT01309360|147161226|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
73806172|NCT01309360|147161226|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
73806173|NCT02016105|147161247|EQUIVALENCE|Adjusted response rates were estimated using a logistic regression model including treatment, body weight strata, region and prior systemic therapy. The 95% CI for the rate difference was derived based on the normal approximation and standard error computed using the delta method.To conclude equivalent efficacy, the 95% CI had to be entirely within the interval \[-18%, 18%\].|Risk Difference (RD)|1.8|STANDARD_ERROR_OF_MEAN|4.75|||TWO_SIDED|95.0|-7.46|11.15||||||||11.15|-7.46|
73806174|NCT02016105|147161248|EQUIVALENCE|"LS means, SE and 95% CI were estimated by a Mixed Model Repeated Measures (MMRM) model with treatment, visit, treatment-by-visit interaction, body weight strata, region and prior systemic therapy, as fixed factors and baseline PASI score as covariate.~Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira treatment was contained within the interval \[-15%; 15%\]."|LS means difference|0.8|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-3.15|4.84||||||||4.84|-3.15|
73806175|NCT02016105|147161249|EQUIVALENCE|LSM, SE and 95% CI were estimated using an ANCOVA model with treatment, body weight strata, region and prior systemic therapy as fixed effects and baseline PASI score as covariate. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira was contained within the interval \[-15%; 15%\].|LS means difference|1.2|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-2.78|5.08||||||||5.08|-2.78|
73806176|NCT02115581|147161290|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.267
73806177|NCT02115581|147161291|SUPERIORITY_OR_OTHER|||||||0.011|||||||Fisher Exact|||||||0.011
73806178|NCT01377922|147161292|OTHER|Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline QMG score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.||||||0.0452|||||||Mixed Models Analysis|Pairwise contrast at Day 14 from MMRM model.||||||0.0452
73806179|NCT01377922|147161293|OTHER|||||||0.0028||||||Pairwise contrast at Day 14 from MMRM model.|Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline SGI score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients||||0.0028
73806180|NCT01377922|147161294|OTHER|||||||0.6274|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline T25FW walking speed as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.||||0.6274
73806181|NCT01377922|147161295|OTHER|||||||0.0267|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction as fixed effects and patient as a random effect. The model assumed time effect to be random between patients||||0.0267
73806182|NCT02644668|147161359|SUPERIORITY||Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.9086|TWO_SIDED|95.0|-0.13|0.11|||Mixed Models Analysis|||||0.11|-0.13|0.9086
73806183|NCT02644668|147161359|SUPERIORITY||Least squares mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.065||0.4361|TWO_SIDED|95.0|-0.18|0.08|||Mixed Models Analysis|||||0.08|-0.18|0.4361
73806184|NCT02644668|147161360|SUPERIORITY||Least squares mean difference|-2.94|STANDARD_ERROR_OF_MEAN|4.749||0.5382|TWO_SIDED|95.0|-12.43|6.55|||Mixed Models Analysis|||||6.55|-12.43|0.5382
73806185|NCT02644668|147161360|SUPERIORITY||Least squares mean difference|0.99|STANDARD_ERROR_OF_MEAN|5.099||0.8464|TWO_SIDED|95.0|-9.19|11.18|||Mixed Models Analysis|||||11.18|-9.19|0.8464
73806186|NCT02644668|147161361|SUPERIORITY||Least squares mean difference|11.69|STANDARD_ERROR_OF_MEAN|5.506||0.0378|TWO_SIDED|95.0|0.68|22.7|||Mixed Models Analysis|||||22.70|0.68|0.0378
73806187|NCT02644668|147161361|SUPERIORITY||Least squares mean difference|13.15|STANDARD_ERROR_OF_MEAN|5.913||0.0298|TWO_SIDED|95.0|1.33|24.97|||Mixed Models Analysis|||||24.97|1.33|0.0298
73806188|NCT02644668|147161362|SUPERIORITY||Least squares mean difference|-4.59|STANDARD_ERROR_OF_MEAN|7.56||0.5461|TWO_SIDED|95.0|-19.69|10.52|||Mixed Models Analysis|||||10.52|-19.69|0.5461
73806189|NCT02644668|147161362|SUPERIORITY||Least squares mean difference|-15.23|STANDARD_ERROR_OF_MEAN|8.175||0.0672|TWO_SIDED|95.0|-31.56|1.11|||Mixed Models Analysis|||||1.11|-31.56|0.0672
73806190|NCT02644668|147161363|SUPERIORITY||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.928||0.6849|TWO_SIDED|95.0|-2.23|1.48|||Mixed Models Analysis|||||1.48|-2.23|0.6849
73806191|NCT02644668|147161363|SUPERIORITY||Least squares mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.98||0.3091|TWO_SIDED|95.0|-2.96|0.95|||Mixed Models Analysis|||||0.95|-2.96|0.3091
73806192|NCT02644668|147161364|SUPERIORITY||Least squares mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.571||0.2878|TWO_SIDED|95.0|-0.53|1.75|||Mixed Models Analysis|||||1.75|-0.53|0.2878
73806193|NCT02644668|147161364|SUPERIORITY||Least squares mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.616||0.8512|TWO_SIDED|95.0|-1.34|1.11|||Mixed Models Analysis|||||1.11|-1.34|0.8512
73806194|NCT02644668|147161365|SUPERIORITY||Least squares mean difference|-0.78|STANDARD_ERROR_OF_MEAN|2.528||0.7612|TWO_SIDED|95.0|-6.08|4.52|||Mixed Models Analysis|||||4.52|-6.08|0.7612
73806195|NCT02644668|147161365|SUPERIORITY||Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|3.231||0.3502|TWO_SIDED|95.0|-9.91|3.7|||Mixed Models Analysis|||||3.70|-9.91|0.3502
73806196|NCT02644668|147161366|SUPERIORITY||Least squares mean difference|7.72|STANDARD_ERROR_OF_MEAN|10.484||0.4684|TWO_SIDED|95.0|-13.86|29.3|||Mixed Models Analysis|||||29.30|-13.86|0.4684
73806197|NCT02644668|147161366|SUPERIORITY||Least squares mean difference|24.89|STANDARD_ERROR_OF_MEAN|12.55||0.0584|TWO_SIDED|95.0|-0.95|50.74|||Mixed Models Analysis|||||50.74|-0.95|0.0584
73806198|NCT02644668|147161367|SUPERIORITY||Odds Ratio (OR)|0.43||||0.1686|TWO_SIDED|95.0|0.13|1.43|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||1.43|0.13|0.1686
73806199|NCT02644668|147161367|SUPERIORITY||Odds Ratio (OR)|0.67||||0.5259|TWO_SIDED|95.0|0.2|2.3|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||2.30|0.20|0.5259
73806200|NCT02644668|147161368|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7655|TWO_SIDED|95.0|0.34|4.4|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||4.40|0.34|0.7655
73806201|NCT02644668|147161368|SUPERIORITY||Odds Ratio (OR)|1.61||||0.492|TWO_SIDED|95.0|0.41|6.25|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||6.25|0.41|0.4920
73806202|NCT02547220|147161409|SUPERIORITY||Difference in percentage|2.6||||0.6857|TWO_SIDED|95.0|-29.4|34.5|||Fisher Exact||Difference in percentage was calculated by the difference in percentage of new or worsening TG at 6 months between CINRYZE and placebo|||34.5|-29.4|0.6857
73806203|NCT00789698|147161481|NON_INFERIORITY_OR_EQUIVALENCE|This is a non-inferiority analysis. Lurasidone will be declared as effective as quetiapine XR in preventing relapse if the upper bound of a 2-sided 95% confidence limit for the hazard ration of lurasidone vs. quetiapine is no greater than an equivalence hazard ratio margin of 1.93.|Hazard Ratio (HR)|0.728|||||TWO_SIDED|95.0|0.41|1.295||There is no hypothesis tested. Since this was a non-inferiority study, the upper bound of the 95% CI for the hazard ratio was compared to the pre-specified margin of 1.93 to demonstrate the non-inferiority of lurasidone compared to Quetiapine XR.|COX Proportional Hazards Model|||Comparison of time to relapse of psychotic symptoms between LUR-LUR and QXR-QXR as analyzed using the Cox proportional-hazards model.||1.295|0.410|
73806204|NCT00468481|147161570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|384.7|||<|0.0001||95.0|282.42|486.98|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (RBC folate) as covariate|Difference = DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the RBC folate levels at week 24 was 0.||486.98|282.42|<0.0001
73806205|NCT00468481|147161571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.87|||<|0.0001||95.0|14.04|23.7|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (plasma folate) as covariate|Difference =DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the plasma folate levels at week 24 was 0.||23.70|14.04|<0.0001
73806206|NCT00734162|147161617|SUPERIORITY_OR_OTHER||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant.|Cochran-Mantel-Haenszel|||Analysis is the difference between treatment groups in the proportion of participants who met the outcome measure criterion, controlling for randomization age group.||||< 0.001
73806207|NCT01515865|147161681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8||||0.3145|TWO_SIDED|95.0|-37.6|9.8|||Fisher Exact|||||9.8|-37.6|0.3145
73806208|NCT01073605|147161682|SUPERIORITY_OR_OTHER|||||||0.02922|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.02922
73806209|NCT01073605|147161682|SUPERIORITY_OR_OTHER|||||||0.74299|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.74299
73806210|NCT01073605|147161682|SUPERIORITY_OR_OTHER|||||||0.00467|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.00467
73806211|NCT01073605|147161684|SUPERIORITY_OR_OTHER|||||||0.00125|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.00125
73806212|NCT01073605|147161684|SUPERIORITY_OR_OTHER|||||||0.25995|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.25995
73806213|NCT01073605|147161684|SUPERIORITY_OR_OTHER|||||||8e-05|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.00008
73806214|NCT01073605|147161684|SUPERIORITY_OR_OTHER|||||||0.03273|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.03273
73806215|NCT01073605|147161684|SUPERIORITY_OR_OTHER|||||||0.68581|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.68581
73806216|NCT01073605|147161684|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.00530
73806217|NCT01073605|147161684|SUPERIORITY_OR_OTHER|||||||0.57556|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.57556
73806218|NCT01073605|147161684|SUPERIORITY_OR_OTHER|||||||0.63956|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.63956
73806219|NCT01073605|147161684|SUPERIORITY_OR_OTHER|||||||0.16421|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.16421
73806220|NCT01073605|147161688|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.0001
73806221|NCT01073605|147161688|SUPERIORITY_OR_OTHER|||||||0.58324|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.58324
73806222|NCT01073605|147161688|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||<0.0001
73806223|NCT01073605|147161693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.0681|TWO_SIDED|95.0|-0.05|1.39||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||1.39|-0.05|0.0681
73806224|NCT01073605|147161693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.8971|TWO_SIDED|95.0|-0.65|0.74||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||0.74|-0.65|0.8971
73806225|NCT01073605|147161693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.0583|TWO_SIDED|95.0|-1.27|0.02||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||0.02|-1.27|0.0583
73806226|NCT02308540|147161714|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.31||||0.0025|TWO_SIDED|90.0|0.17|0.57|||t-test, 2 sided|||||0.57|0.17|0.0025
73806227|NCT02308540|147161714|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|0.74||||0.454|TWO_SIDED|90.0|0.38|1.45|||t-test, 2 sided|||||1.45|0.38|0.4540
73806228|NCT02308540|147161714|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|4.69||||0.0003|TWO_SIDED|90.0|2.46|8.94|||t-test, 2 sided|||||8.94|2.46|0.0003
73806229|NCT02308540|147161714|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|2.22||||0.046|TWO_SIDED|90.0|1.16|4.24|||t-test, 2 sided|||||4.24|1.16|0.0460
73806230|NCT02308540|147161714|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.76||||0.3365|TWO_SIDED|90.0|0.47|1.22|||t-test, 2 sided|||||1.22|0.47|0.3365
73806231|NCT02308540|147161714|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.56||||0.0313|TWO_SIDED|90.0|0.37|0.87|||t-test, 2 sided|||||0.87|0.37|0.0313
73806232|NCT02308540|147161714|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.08||||0.806|TWO_SIDED|90.0|0.65|1.79|||t-test, 2 sided|||||1.79|0.65|0.8060
73806233|NCT02308540|147161714|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|1.74||||0.2044|TWO_SIDED|90.0|0.84|3.58|||t-test, 2 sided|||||3.58|0.84|0.2044
73806234|NCT02308540|147161714|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|1.67||||0.149|TWO_SIDED|90.0|0.93|3.02|||t-test, 2 sided|||||3.02|0.93|0.1490
73806235|NCT02308540|147161714|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|1.13||||0.7565|TWO_SIDED|90.0|0.59|2.15|||t-test, 2 sided|||||2.15|0.59|0.7565
73806236|NCT02308540|147161715|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 1 GMC Ratio|0.75||||0.2653|TWO_SIDED|90.0|0.54|1.31|||Two-tailed from z-test|||||1.31|0.54|0.2653
73806237|NCT02308540|147161715|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 5 GMC Ratio|0.69||||0.2059|TWO_SIDED|90.0|0.45|1.2|||Two-tailed from z-test|||||1.20|0.45|0.2059
73806238|NCT02308540|147161715|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6A GMC Ratio|0.84||||0.5664|TWO_SIDED|90.0|0.55|1.54|||Two-tailed from z-test|||||1.54|0.55|0.5664
73806239|NCT02308540|147161715|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6B GMC Ratio|0.82||||0.4456|TWO_SIDED|90.0|0.57|1.31|||Two-tailed from z-test|||||1.31|0.57|0.4456
73806240|NCT02308540|147161715|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 7F GMC Ratio|0.74||||0.2189|TWO_SIDED|90.0|0.52|1.14|||Two-tailed from z-test|||||1.14|0.52|0.2189
73806241|NCT02308540|147161715|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 9V GMC Ratio|0.6||||0.097|TWO_SIDED|90.0|0.38|1.03|||Two-tailed from z-test|||||1.03|0.38|0.0970
73806242|NCT02308540|147161715|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 14 GMC Ratio|1.76||||0.0713|TWO_SIDED|90.0|1.02|2.79|||Two-tailed from z-test|||||2.79|1.02|0.0713
73806243|NCT02308540|147161715|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19A GMC Ratio|0.71||||0.3443|TWO_SIDED|90.0|0.42|1.35|||Two-tailed from z-test|||||1.35|0.42|0.3443
73806244|NCT02308540|147161715|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19F GMC Ratio|0.76||||0.3278|TWO_SIDED|90.0|0.48|1.23|||Two-tailed from z-test|||||1.23|0.48|0.3278
73806245|NCT02308540|147161715|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 23F GMC Ratio|0.65||||0.2039|TWO_SIDED|90.0|0.4|1.16|||Two-tailed from z-test|||||1.16|0.40|0.2039
73806246|NCT02308540|147161716|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.89||||0.255|TWO_SIDED|90.0|0.74|1.06|||t-test, 2 sided|||||1.06|0.74|0.2550
73806247|NCT02308540|147161716|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|1.2||||0.0865|TWO_SIDED|90.0|1.01|1.43|||t-test, 2 sided|||||1.43|1.01|0.0865
73806248|NCT02308540|147161716|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|0.56||||0.0006|TWO_SIDED|90.0|0.43|0.74|||t-test, 2 sided|||||0.74|0.43|0.0006
73806249|NCT02308540|147161716|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|0.43|||<|0.0001|TWO_SIDED|90.0|0.33|0.57|||t-test, 2 sided|||||0.57|0.33|<0.0001
73895545|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|-0.3||||0.921|TWO_SIDED|95.0|-6.19|5.67|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 24||5.67|-6.19|0.921
73895546|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|3.3||||0.41|TWO_SIDED|95.0|-2.19|8.86|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 28||8.86|-2.19|0.410
73806250|NCT02308540|147161716|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.56|||<|0.0001|TWO_SIDED|90.0|0.47|0.68|||t-test, 2 sided|||||0.68|0.47|<0.0001
73806251|NCT02308540|147161716|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.49|||<|0.0001|TWO_SIDED|90.0|0.41|0.59|||t-test, 2 sided|||||0.59|0.41|<0.0001
73806252|NCT02308540|147161716|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.11||||0.5234|TWO_SIDED|90.0|0.85|1.45|||t-test, 2 sided|||||1.45|0.85|0.5234
73806253|NCT02308540|147161716|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|0.29|||<|0.0001|TWO_SIDED|90.0|0.22|0.36|||t-test, 2 sided|||||0.36|0.22|<0.0001
73806254|NCT02308540|147161716|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|0.72||||0.004|TWO_SIDED|90.0|0.6|0.87|||t-test, 2 sided|||||0.87|0.60|0.0040
73806255|NCT02308540|147161716|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|0.58||||0.0001|TWO_SIDED|90.0|0.46|0.73|||t-test, 2 sided|||||0.73|0.46|0.0001
73806256|NCT02308540|147161718|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 1|-1.0|||||TWO_SIDED|90.0|-5.13|2.66||||||||2.66|-5.13|
73806257|NCT02308540|147161718|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 5|3.0|||||TWO_SIDED|90.0|-1.1|7.95||||||||7.95|-1.10|
73806258|NCT02308540|147161718|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6A|-12.0|||||TWO_SIDED|90.0|-20.94|-2.97||||||||-2.97|-20.94|
73806259|NCT02308540|147161718|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6B|-7.9|||||TWO_SIDED|90.0|-15.0|-1.01||||||||-1.01|-15.0|
73806260|NCT02308540|147161718|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 7F|-3.0|||||TWO_SIDED|90.0|-7.95|1.1||||||||1.10|-7.95|
73806261|NCT02308540|147161718|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 9V|-3.0|||||TWO_SIDED|90.0|-9.17|2.9||||||||2.90|-9.17|
73806262|NCT02308540|147161718|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 14|1.0|||||TWO_SIDED|90.0|-4.0|6.27||||||||6.27|-4.00|
73806263|NCT02308540|147161718|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19A|-5.9|||||TWO_SIDED|90.0|-12.38|0.17||||||||0.17|-12.38|
73806264|NCT02308540|147161718|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19F|0.0|||||TWO_SIDED|90.0|-4.22|4.33||||||||4.33|-4.22|
73806265|NCT02308540|147161718|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 23F|-6.0|||||TWO_SIDED|90.0|-12.77|0.4||||||||0.40|-12.77|
73806266|NCT02308540|147161720|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 1|9.1|||||TWO_SIDED|90.0|-15.55|36.11||||||||36.11|-15.55|
73806267|NCT02308540|147161720|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 5|0.0|||||TWO_SIDED|90.0|-18.56|18.56||||||||18.56|-18.56|
73806268|NCT02308540|147161720|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 6B|5.0|||||TWO_SIDED|90.0|-12.35|22.97||||||||22.97|-12.35|
73806269|NCT02308540|147161720|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 14|5.3|||||TWO_SIDED|90.0|-12.15|24.01||||||||24.01|-12.15|
73806270|NCT02308540|147161720|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19A|-5.9|||||TWO_SIDED|90.0|-26.41|11.01||||||||11.01|-26.41|
73806271|NCT02308540|147161720|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19F|5.0|||||TWO_SIDED|90.0|-11.64|22.97||||||||22.97|-11.64|
73806272|NCT02649439|147161756|SUPERIORITY|||||||0.4852|||||||Wilcoxon signed rank test|||||||0.4852
73806273|NCT02649439|147161757|SUPERIORITY|||||||0.3269|||||||Wilcoxon signed rank test|||||||0.3269
73806274|NCT02649439|147161760|SUPERIORITY|||||||0.0255||||||The reported p-value is representative of the PBMCs in monocyte nonclassical between responders and non-responders.|Mann Whitney Test|||||||0.0255
73806275|NCT02649439|147161760|OTHER|||||||0.0021||||||The reported p-value is representative of the PBMCs in monocyte nonclassical PD-L1+ between responders and non-responders.|Mann Whitney Test|||||||0.0021
73806276|NCT02649439|147161760|SUPERIORITY|||||||0.0486||||||The reported p-value is representative of the PBMCs in monocyte PD-1+ between responders and non-responders.|Mann Whitney Test|||||||0.0486
73806277|NCT02649439|147161761|SUPERIORITY|||||||0.7317||||||The reported p-value is representative of the PBMCs in CD4 between responders and non-responders.|Mann Whitney Test|||||||0.7317
73806278|NCT02649439|147161761|SUPERIORITY|||||||0.7545||||||The reported p-value is representative of the PBMCs in CD8 between responders and non-responders.|Mann Whitney Test|||||||0.7545
73806279|NCT02649439|147161761|SUPERIORITY|||||||0.531||||||The reported p-value is representative of the PBMCs in Treg between responders and non-responders.|Mann Whitney Test|||||||0.5310
73806280|NCT02649439|147161761|SUPERIORITY|||||||0.8451||||||The reported p-value is representative of the PBMCs in NK between responders and non-responders.|Mann Whitney Test|||||||0.8451
73806281|NCT02649439|147161761|SUPERIORITY|||||||0.9377||||||The reported p-value is representative of the PBMCs in MDSC between responders and non-responders.|Mann Whitney Test|||||||0.9377
73806282|NCT02649439|147161762|SUPERIORITY|||||||0.2012||||||The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.2012
73806283|NCT02649439|147161762|SUPERIORITY|||||||0.4891||||||The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.4891
73806284|NCT02649439|147161762|SUPERIORITY|||||||0.4609||||||The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.4609
73806285|NCT02649439|147161762|SUPERIORITY|||||||0.0012||||||The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.0012
73806286|NCT02649439|147161762|SUPERIORITY|||||||0.0825||||||The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.0825
73806287|NCT02649439|147161762|SUPERIORITY|||||||0.5988||||||The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.5988
73806288|NCT02649439|147161762|SUPERIORITY|||||||0.592|||||||Wilcoxon signed rank test|The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.||||||0.5920
73806289|NCT02649439|147161762|SUPERIORITY|||||||0.6221||||||The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.6221
73806290|NCT02649439|147161762|SUPERIORITY|||||||0.7334||||||The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7334
73806291|NCT02649439|147161762|OTHER|||||||0.791||||||The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7910
73806292|NCT02649439|147161762|SUPERIORITY|||||||0.5186||||||The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.5186
73806293|NCT02649439|147161762|SUPERIORITY|The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.||||||0.5186|||||||Wilcoxon signed rank test|||||||0.5186
73806294|NCT02649439|147161762|SUPERIORITY|||||||0.9097||||||The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.9097
73806295|NCT02649439|147161762|SUPERIORITY|||||||0.7334||||||The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7334
73806296|NCT00945035|147161763|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \[GMR\] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.02||||||90.0|0.97|1.07||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction||1.07|0.97|
73895547|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|6.4||||0.073|TWO_SIDED|95.0|0.41|12.48|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 36||12.48|0.41|0.073
73806297|NCT00945035|147161764|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \[GMR\] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.03||||||90.0|0.95|1.11||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction||1.11|0.95|
73806298|NCT01908829|147161779|SUPERIORITY||Least Squares (LS) Means|-0.26|STANDARD_ERROR_OF_MEAN|0.11|=|0.001|TWO_SIDED|95.0|-0.47|-0.05||P values for pairwise comparisons were from the stratified rank ANCOVA model. P \< 0.05 indicated superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% Confidence Intervals (CIs) are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.05|-0.47|=0.001
73806299|NCT01908829|147161780|SUPERIORITY||LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.14||P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.14|-0.52|<0.001
73806300|NCT01908829|147161780|SUPERIORITY||LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.18||P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.18|-0.60|<0.001
73806301|NCT01908829|147161780|SUPERIORITY||LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.11|=|0.001|TWO_SIDED|95.0|-0.46|-0.03||P-values for pairwise comparisons are from the stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.03|-0.46|=0.001
73806302|NCT01908829|147161781|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.1|=|0.01|TWO_SIDED|95.0|-0.47|-0.06||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.06|-0.47|=0.010
73806303|NCT01908829|147161781|SUPERIORITY||LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.65|-0.19||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.19|-0.65|<0.001
73806304|NCT01908829|147161781|SUPERIORITY||LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.23||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.23|-0.70|<0.001
73806305|NCT01908829|147161781|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.67|-0.22||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.22|-0.67|<0.001
73806306|NCT01908829|147161782|SUPERIORITY||Rate Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.05|=|0.005|TWO_SIDED|95.0|0.79|0.96||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 4 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.96|0.79|=0.005
73806307|NCT01908829|147161782|SUPERIORITY||Rate Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.66|0.86||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 8 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.86|0.66|<0.001
73806308|NCT01908829|147161782|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.021|TWO_SIDED|95.0|0.7|0.97||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 12 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.97|0.70|=0.021
73806309|NCT01908829|147161782|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.014|TWO_SIDED|95.0|0.71|0.96||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during EoT 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.96|0.71|=0.014
73806310|NCT01908829|147161783|SUPERIORITY||LS Means|3.86|STANDARD_ERROR_OF_MEAN|2.19|<|0.078|TWO_SIDED|95.0|-0.43|8.16||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||8.16|-0.43|<0.078
73806311|NCT01908829|147161783|SUPERIORITY||LS Means|11.19|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|5.98|16.4||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||16.40|5.98|<0.001
73806312|NCT01908829|147161783|SUPERIORITY||LS Means|12.38|STANDARD_ERROR_OF_MEAN|2.92|<|0.001|TWO_SIDED|95.0|6.65|18.12||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||18.12|6.65|<0.001
73806313|NCT01908829|147161783|SUPERIORITY||LS Means|11.52|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|6.06|16.99||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||16.99|6.06|<0.001
73806314|NCT01908829|147161784|SUPERIORITY||LS Means|-0.44|STANDARD_ERROR_OF_MEAN|0.15|=|0.003|TWO_SIDED|95.0|-0.73|-0.16||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.16|-0.73|=0.003
73806315|NCT01908829|147161785|SUPERIORITY||LS Means|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.54|-0.17||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.17|-0.54|<0.001
73895548|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|4.6||||0.219|TWO_SIDED|95.0|-0.97|10.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 44||10.08|-0.97|0.219
73895549|NCT01578850|147324502|SUPERIORITY_OR_OTHER||Difference in proportions|5.9||||0.196|TWO_SIDED|95.0|-0.6|12.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 52||12.40|-0.60|0.196
73895550|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.062|TWO_SIDED|95.0|-1.84|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 28||0.05|-1.84|0.062
73806316|NCT01908829|147161785|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.25||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 djusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.25|-0.65|<0.001
73806317|NCT01908829|147161785|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.11|=|0.004|TWO_SIDED|95.0|-0.47|-0.05||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.05|-0.47|=0.004
73806318|NCT01908829|147161785|SUPERIORITY||LS Means|-0.27|STANDARD_ERROR_OF_MEAN|0.1|=|0.003|TWO_SIDED|95.0|-0.47|-0.07||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.07|-0.47|=0.003
73806319|NCT01908829|147161786|SUPERIORITY||Rate Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.05|=|0.003|TWO_SIDED|95.0|0.76|0.94||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 4 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.94|0.76|=0.003
73806320|NCT01908829|147161786|SUPERIORITY||Rate Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.63|0.86||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 8 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.86|0.63|<0.001
73806321|NCT01908829|147161786|SUPERIORITY||Rate Ratio|0.83|STANDARD_ERROR_OF_MEAN|0.09|=|0.038|TWO_SIDED|95.0|0.69|0.99||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 12 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.99|0.69|=0.038
73806322|NCT01908829|147161786|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.09|=|0.022|TWO_SIDED|95.0|0.69|0.97||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of UI episodes during EoT 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.97|0.69|=0.022
73806323|NCT01908829|147161787|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.13|=|0.001|TWO_SIDED|95.0|-0.72|-0.19||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.19|-0.72|=0.001
73806324|NCT01908829|147161787|SUPERIORITY||LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.93|-0.35||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.35|-0.93|<0.001
73895551|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.015|TWO_SIDED|95.0|-2.41|-0.27|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 36||-0.27|-2.41|0.015
73895552|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65||||0.003|TWO_SIDED|95.0|-2.72|-0.57|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 44||-0.57|-2.72|0.003
73895553|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.002|TWO_SIDED|95.0|-2.85|-0.66|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 52||-0.66|-2.85|0.002
73806325|NCT01908829|147161787|SUPERIORITY||LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.15|=|0.001|TWO_SIDED|95.0|-0.82|-0.22||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.22|-0.82|=0.001
73806326|NCT01908829|147161787|SUPERIORITY||LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.83|-0.25||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.25|-0.83|<0.001
73806327|NCT01908829|147161788|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.1|=|0.008|TWO_SIDED|95.0|-0.46|-0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.07|-0.46|=0.008
73806328|NCT01908829|147161788|SUPERIORITY||LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|-0.55|-0.13||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.13|-0.55|=0.002
73806329|NCT01908829|147161788|SUPERIORITY||LS Means|-0.28|STANDARD_ERROR_OF_MEAN|0.1|=|0.006|TWO_SIDED|95.0|-0.47|-0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.08|-0.47|=0.006
73806330|NCT01908829|147161788|SUPERIORITY||LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.1|=|0.002|TWO_SIDED|95.0|-0.51|-0.12||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.12|-0.51|=0.002
73806331|NCT01908829|147161789|SUPERIORITY||Rate Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.06|=|0.545|TWO_SIDED|95.0|0.87|1.08||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.08|0.87|=0.545
73806332|NCT01908829|147161789|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.01|TWO_SIDED|95.0|0.7|0.95||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.95|0.70|=0.010
73806333|NCT01908829|147161789|SUPERIORITY||Rate Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.09|=|0.007|TWO_SIDED|95.0|0.67|0.94||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.94|0.67|=0.007
73806334|NCT01908829|147161789|SUPERIORITY||Rate Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.08|=|0.003|TWO_SIDED|95.0|0.66|0.92||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.92|0.66|=0.003
73895554|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.68|TWO_SIDED|95.0|-0.77|0.5|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 28||0.50|-0.77|0.680
73806335|NCT01908829|147161790|SUPERIORITY||LS Means|-0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.836|TWO_SIDED|95.0|-0.1|0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.08|-0.10|=0.836
73806336|NCT01908829|147161790|SUPERIORITY||LS Means|-0.02|STANDARD_ERROR_OF_MEAN|0.05|=|0.617|TWO_SIDED|95.0|-0.12|0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.07|-0.12|=0.617
73806337|NCT01908829|147161790|SUPERIORITY||LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.05|=|0.134|TWO_SIDED|95.0|-0.17|0.02||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.02|-0.17|=0.134
73806338|NCT01908829|147161790|SUPERIORITY||LS Means|-0.06|STANDARD_ERROR_OF_MEAN|0.05|=|0.174|TWO_SIDED|95.0|-0.16|0.03||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EOT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.03|-0.16|=0.174
73806339|NCT01908829|147161791|SUPERIORITY||Rate Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.04|=|0.993|TWO_SIDED|95.0|0.93|1.08||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.08|0.93|=0.993
73806340|NCT01908829|147161791|SUPERIORITY||Rate Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.04|=|0.736|TWO_SIDED|95.0|0.9|1.07||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.07|0.90|=0.736
73806341|NCT01908829|147161791|SUPERIORITY||Rate Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.05|=|0.121|TWO_SIDED|95.0|0.85|1.02||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.02|0.85|=0.121
73806342|NCT01908829|147161791|SUPERIORITY||Rate Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.04|=|0.172|TWO_SIDED|95.0|0.86|1.03||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.03|0.86|=0.172
73806343|NCT01908829|147161797|SUPERIORITY||LS Means|-2.89|STANDARD_ERROR_OF_MEAN|0.91|=|0.002|TWO_SIDED|95.0|-4.68|-1.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-1.10|-4.68|=0.002
73806344|NCT01908829|147161797|SUPERIORITY||LS Means|-4.5|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|-6.4|-2.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-2.60|-6.40|<0.001
73806345|NCT01908829|147161797|SUPERIORITY||LS Means|-5.59|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-7.56|-3.62||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-3.62|-7.56|<0.001
73806346|NCT01908829|147161797|SUPERIORITY||LS Means|-4.96|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|-6.88|-3.04||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-3.04|-6.88|<0.001
73806347|NCT01908829|147161798|SUPERIORITY||LS Means|1.92|STANDARD_ERROR_OF_MEAN|0.83|=|0.021|TWO_SIDED|95.0|0.29|3.55||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.55|0.29|=0.021
73806348|NCT01908829|147161798|SUPERIORITY||LS Means|2.31|STANDARD_ERROR_OF_MEAN|0.89|=|0.01|TWO_SIDED|95.0|0.56|4.06||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.06|0.56|=0.010
73806349|NCT01908829|147161798|SUPERIORITY||LS Means|3.49|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|1.65|5.33||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.33|1.65|<0.001
73806350|NCT01908829|147161798|SUPERIORITY||LS Means|3.15|STANDARD_ERROR_OF_MEAN|0.92|=|0.001|TWO_SIDED|95.0|1.35|4.95||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.95|1.35|=0.001
73806351|NCT01908829|147161799|SUPERIORITY||LS Means|2.9|STANDARD_ERROR_OF_MEAN|0.96|=|0.003|TWO_SIDED|95.0|1.02|4.78||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.78|1.02|=0.003
73806352|NCT01908829|147161799|SUPERIORITY||LS Means|3.35|STANDARD_ERROR_OF_MEAN|1.05|=|0.001|TWO_SIDED|95.0|1.29|5.4||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.40|1.29|=0.001
73806353|NCT01908829|147161799|SUPERIORITY||LS Means|4.71|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|2.55|6.87||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||6.87|2.55|<0.001
73806354|NCT01908829|147161799|SUPERIORITY||LS Means|4.29|STANDARD_ERROR_OF_MEAN|1.07|<|0.001|TWO_SIDED|95.0|2.2|6.39||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||6.39|2.20|<0.001
73806355|NCT01908829|147161800|SUPERIORITY||LS Means|1.94|STANDARD_ERROR_OF_MEAN|0.96|=|0.044|TWO_SIDED|95.0|0.05|3.83||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.83|0.05|=0.044
73806356|NCT01908829|147161800|SUPERIORITY||LS Means|2.5|STANDARD_ERROR_OF_MEAN|1.0|=|0.012|TWO_SIDED|95.0|0.55|4.46||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.46|0.55|=0.012
73806357|NCT01908829|147161800|SUPERIORITY||LS Means|3.61|STANDARD_ERROR_OF_MEAN|1.05|=|0.001|TWO_SIDED|95.0|1.54|5.67||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.67|1.54|=0.001
73806358|NCT01908829|147161800|SUPERIORITY||LS Means|3.28|STANDARD_ERROR_OF_MEAN|1.03|=|0.001|TWO_SIDED|95.0|1.27|5.29||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.29|1.27|=0.001
73806359|NCT01908829|147161801|SUPERIORITY||LS Means|0.54|STANDARD_ERROR_OF_MEAN|0.96|=|0.575|TWO_SIDED|95.0|-1.35|2.43||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||2.43|-1.35|=0.575
73806360|NCT01908829|147161801|SUPERIORITY||LS Means|1.61|STANDARD_ERROR_OF_MEAN|1.0|=|0.109|TWO_SIDED|95.0|-0.36|3.58||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.58|-0.36|=0.109
73806361|NCT01908829|147161801|SUPERIORITY||LS Means|2.26|STANDARD_ERROR_OF_MEAN|1.05|=|0.032|TWO_SIDED|95.0|0.2|4.32||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.32|0.20|=0.032
73806362|NCT01908829|147161801|SUPERIORITY||LS Means|1.86|STANDARD_ERROR_OF_MEAN|1.02|=|0.069|TWO_SIDED|95.0|-0.15|3.87||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.87|-0.15|=0.069
73806363|NCT01908829|147161802|SUPERIORITY||LS Means|1.73|STANDARD_ERROR_OF_MEAN|0.83|=|0.037|TWO_SIDED|95.0|0.1|3.36||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.36|0.10|=0.037
73806364|NCT01908829|147161802|SUPERIORITY||LS Means|1.09|STANDARD_ERROR_OF_MEAN|0.85|=|0.199|TWO_SIDED|95.0|-0.57|2.76||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||2.76|-0.57|=0.199
73895555|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.437|TWO_SIDED|95.0|-1.04|0.45|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 36||0.45|-1.04|0.437
73806365|NCT01908829|147161802|SUPERIORITY||LS Means|2.62|STANDARD_ERROR_OF_MEAN|0.87|=|0.003|TWO_SIDED|95.0|0.92|4.31||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.31|0.92|=0.003
73806366|NCT01908829|147161802|SUPERIORITY||LS Means|2.48|STANDARD_ERROR_OF_MEAN|0.85|=|0.004|TWO_SIDED|95.0|0.81|4.15||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.15|0.81|=0.004
73806367|NCT01908829|147161803|SUPERIORITY||LS Means|0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.6|0.2|<0.001
73806368|NCT01908829|147161803|SUPERIORITY||LS Means|0.3|STANDARD_ERROR_OF_MEAN|0.1|=|0.019|TWO_SIDED|95.0|0.0|0.5||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.5|0.0|=0.019
73806369|NCT01908829|147161803|SUPERIORITY||LS Means|0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.3|0.7||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.7|0.3|<0.001
73806370|NCT01908829|147161803|SUPERIORITY||LS Means|0.4|STANDARD_ERROR_OF_MEAN|0.1|=|0.001|TWO_SIDED|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.6|0.2|=0.001
73806371|NCT01908829|147161804|SUPERIORITY||LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
73806372|NCT01908829|147161804|SUPERIORITY||LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
73806373|NCT01908829|147161804|SUPERIORITY||LS Means|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.2||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.2|-0.4|<0.001
73895556|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.131|TWO_SIDED|95.0|-1.31|0.17|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 44||0.17|-1.31|0.131
73895557|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.199|TWO_SIDED|95.0|-1.22|0.25|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 52||0.25|-1.22|0.199
73895558|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.115|TWO_SIDED|95.0|-2.6|0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 28||0.28|-2.60|0.115
73806374|NCT01908829|147161804|SUPERIORITY||LS Means|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
73806375|NCT01908829|147161806|SUPERIORITY||Odds Ratio (OR)|1.48|||<|0.001|TWO_SIDED|95.0|1.19|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.19|<0.001
73806376|NCT01908829|147161806|SUPERIORITY||Odds Ratio (OR)|1.57|||<|0.001|TWO_SIDED|95.0|1.25|1.98||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.98|1.25|<0.001
73806377|NCT01908829|147161806|SUPERIORITY||Odds Ratio (OR)|1.54|||=|0.001|TWO_SIDED|95.0|1.21|1.95||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.95|1.21|=0.001
73806378|NCT01908829|147161806|SUPERIORITY||Odds Ratio (OR)|1.51|||<|0.001|TWO_SIDED|95.0|1.2|1.9||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.90|1.20|<0.001
73806379|NCT01908829|147161807|SUPERIORITY||Odds Ratio (OR)|1.24|||=|0.119|TWO_SIDED|95.0|0.95|1.63||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.63|0.95|=0.119
73806380|NCT01908829|147161807|SUPERIORITY||Odds Ratio (OR)|1.56|||<|0.001|TWO_SIDED|95.0|1.23|1.98||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.98|1.23|<0.001
73806381|NCT01908829|147161807|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.002|TWO_SIDED|95.0|1.14|1.82||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.82|1.14|=0.002
73806382|NCT01908829|147161807|SUPERIORITY||Odds Ratio (OR)|1.47|||=|0.001|TWO_SIDED|95.0|1.17|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.17|=0.001
73806383|NCT01908829|147161808|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.305|TWO_SIDED|95.0|0.88|1.5||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.50|0.88|=0.305
73806384|NCT01908829|147161808|SUPERIORITY||Odds Ratio (OR)|1.37|||=|0.014|TWO_SIDED|95.0|1.06|1.76||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.76|1.06|=0.014
73806385|NCT01908829|147161808|SUPERIORITY||Odds Ratio (OR)|1.37|||=|0.012|TWO_SIDED|95.0|1.07|1.76||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.76|1.07|=0.012
73806386|NCT01908829|147161808|SUPERIORITY||Odds Ratio (OR)|1.29|||=|0.036|TWO_SIDED|95.0|1.02|1.64||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.64|1.02|=0.036
73806387|NCT01908829|147161809|SUPERIORITY||Odds Ratio (OR)|1.49|||=|0.001|TWO_SIDED|95.0|1.18|1.88||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.88|1.18|=0.001
73895559|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.017|TWO_SIDED|95.0|-3.42|-0.35|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 36||-0.35|-3.42|0.017
73806388|NCT01908829|147161809|SUPERIORITY||Odds Ratio (OR)|1.69|||<|0.001|TWO_SIDED|95.0|1.31|2.18||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.18|1.31|<0.001
73806389|NCT01908829|147161809|SUPERIORITY||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.47|2.61||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.61|1.47|<0.001
73806390|NCT01908829|147161809|SUPERIORITY||Odds Ratio (OR)|1.75|||<|0.001|TWO_SIDED|95.0|1.34|2.3||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.30|1.34|<0.001
73806391|NCT01908829|147161810|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.003|TWO_SIDED|95.0|1.14|1.82||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.82|1.14|=0.003
73806392|NCT01908829|147161810|SUPERIORITY||Odds Ratio (OR)|1.51|||=|0.001|TWO_SIDED|95.0|1.18|1.93||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.93|1.18|=0.001
73806393|NCT01908829|147161810|SUPERIORITY||Odds Ratio (OR)|1.64|||<|0.001|TWO_SIDED|95.0|1.27|2.13||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.13|1.27|<0.001
73806394|NCT01908829|147161810|SUPERIORITY||Odds Ratio (OR)|1.5|||=|0.001|TWO_SIDED|95.0|1.17|1.91||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.91|1.17|=0.001
73806395|NCT01908829|147161811|SUPERIORITY||Odds Ratio (OR)|1.42|||=|0.003|TWO_SIDED|95.0|1.13|1.79||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.79|1.13|=0.003
73806396|NCT01908829|147161811|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.004|TWO_SIDED|95.0|1.12|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.12|=0.004
73806397|NCT01908829|147161811|SUPERIORITY||Odds Ratio (OR)|1.5|||=|0.003|TWO_SIDED|95.0|1.15|1.96||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.96|1.15|=0.003
73806398|NCT01908829|147161811|SUPERIORITY||Odds Ratio (OR)|1.43|||=|0.006|TWO_SIDED|95.0|1.11|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.11|=0.006
73806399|NCT01908829|147161812|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.065|TWO_SIDED|95.0|0.99|1.66|||Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.66|0.99|=0.065
73806400|NCT01908829|147161812|SUPERIORITY||Odds Ratio (OR)|1.41|||=|0.004|TWO_SIDED|95.0|1.11|1.79|||Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.79|1.11|=0.004
73806401|NCT01908829|147161812|SUPERIORITY||Odds Ratio (OR)|1.64|||<|0.001|TWO_SIDED|95.0|1.3|2.07|||Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.07|1.30|<0.001
73806402|NCT01908829|147161812|SUPERIORITY||Odds Ratio (OR)|1.55|||<|0.001|TWO_SIDED|95.0|1.24|1.94|||Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.94|1.24|<0.001
73806403|NCT01339923|147161862|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-6.4|3.9|||Miettinen and Nurminen method|||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after 2nd vaccination for serogroup C.||3.9|-6.4|
73806404|NCT01339923|147161862|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-5.2|7.6|||Miettinen and Nurminen method|||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after booster vaccination for serogroup C.||7.6|-5.2|
73806405|NCT01430403|147161896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|0.331||0.03|TWO_SIDED|95.0|0.25|0.92|||Odds Ratio|Adjusted for Site, dosing group and treatment step|Placebo serves as the reference group. Values \< 1 represent more exacerbations in the placebo arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.||0.92|0.25|0.03
73806406|NCT01430403|147161897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|STANDARD_ERROR_OF_MEAN|0.41||0.45|TWO_SIDED|95.0|0.33|1.64|||Odds Ratio|Adjusted for Site, dosing group and treatment step|ICS Boost serves as the reference group. Values \< 1 represent more exacerbations in the ICS arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.||1.64|0.33|0.45
73806407|NCT01430403|147161898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.01|TWO_SIDED|95.0|2.38|5.22|||Chi-squared||Adjusted for site|||5.22|2.38|<0.01
73806408|NCT01430403|147161899|SUPERIORITY_OR_OTHER||Linear Regression|0.004||||0.94|TWO_SIDED|95.0|-0.1|0.11|||F-Test|||||0.11|-0.10|0.94
73806409|NCT01430403|147161899|SUPERIORITY_OR_OTHER||Linear Regression|-0.13||||0.33|TWO_SIDED|95.0|-0.4|0.13|||F-Test|||||0.13|-0.40|0.33
73806410|NCT01430403|147161900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.552|TWO_SIDED|95.0|0.87|1.31|||Chi-squared|||||1.31|0.87|0.552
73806411|NCT01430403|147161900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.37|TWO_SIDED|95.0|0.87|1.44|||Chi-squared|||||1.44|0.87|0.37
73806412|NCT01430403|147161901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.3||0.09|TWO_SIDED|95.0|-1.11|0.07|||Regression, Linear|Adjustments for randomization CASI, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||0.07|-1.11|0.09
73806413|NCT01430403|147161902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.3||0.39|TWO_SIDED|95.0|-0.86|0.34|||Regression, Linear|Adjustments for randomization CASI, site and dosing group||||0.34|-0.86|0.39
73806414|NCT01430403|147161903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|1.58||0.84|TWO_SIDED|95.0|-3.42|2.78|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||2.78|-3.42|0.84
73806415|NCT01430403|147161904|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|1.59||0.14|TWO_SIDED|95.0|-0.76|5.51|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site and dosing group.||||5.51|-0.76|0.14
73806416|NCT01430403|147161905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.89||0.78|TWO_SIDED|95.0|-1.49|1.99|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.99|-1.49|0.78
73806417|NCT01430403|147161906|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|0.89||0.2|TWO_SIDED|95.0|-0.61|2.91|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site and dosing group.||||2.91|-0.61|0.20
73806418|NCT01430403|147161907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.4||0.006|TWO_SIDED|95.0|0.32|1.9|||Regression, Linear|Adjustments for randomization ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.90|0.32|0.006
73806419|NCT01430403|147161908|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.41||0.89|TWO_SIDED|95.0|-0.76|0.86|||Regression, Linear|Adjustments for randomization ACT, site and dosing group.||||0.86|-0.76|0.89
73806420|NCT01430403|147161909|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|0.36||0.05|TWO_SIDED|95.0|0.0|1.41|||Regression, Linear|Adjustments for randomization C-ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.41|0.00|0.05
73806421|NCT01430403|147161910|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.37||0.12|TWO_SIDED|95.0|-0.15|1.3|||Regression, Linear|Adjustments for randomization C-ACT, site and dosing group||||1.30|-0.15|0.12
73806422|NCT01430403|147161911|SUPERIORITY_OR_OTHER||Rate Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.68||0.63|TWO_SIDED|95.0|0.19|0.72|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||0.72|0.19|0.63
73806423|NCT01430403|147161912|SUPERIORITY_OR_OTHER||Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.63||0.99|TWO_SIDED|95.0|0.29|3.46|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group||||3.46|0.29|0.99
73806424|NCT01430403|147161913|SUPERIORITY_OR_OTHER||Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.32||0.31|TWO_SIDED|95.0|0.39|1.35|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.35|0.39|0.31
73806425|NCT01430403|147161914|SUPERIORITY_OR_OTHER||Ratio|0.48|STANDARD_ERROR_OF_MEAN|0.39||0.06|TWO_SIDED|95.0|0.23|1.02|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group||||1.02|0.23|0.06
73806426|NCT01430403|147161915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|1.48||0.9|TWO_SIDED|95.0|-3.08|2.72|||Regression, Linear|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||2.72|-3.08|0.90
73806427|NCT01430403|147161916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.52||0.86|TWO_SIDED|95.0|-3.26|2.71|||Regression, Linear|Adjustments for site and dosing group.||||2.71|-3.26|0.86
73806428|NCT04481789|147161918|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Rosuvastatin + Edaravone / Rosuvastatin Alone).|LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.97|1.08||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.08|0.97|
73806429|NCT04481789|147161918|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Sildenafil + Edaravone / Sildenafil Alone).|LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.88|0.99||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||0.99|0.88|
73806430|NCT04481789|147161918|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Furosemide + Edaravone / Furosemide Alone).|LS Mean Ratio|1.03|||||TWO_SIDED|90.0|0.98|1.09||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.09|0.98|
73806431|NCT04481789|147161919|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Rosuvastatin + Edaravone / Rosuvastatin).|LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.91|1.06||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.06|0.91|
73806432|NCT04481789|147161919|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Sildenafil + Edaravone / Sildenafil Alone).|LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.8|1.1||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.10|0.80|
73806433|NCT04481789|147161919|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Furosemide + Edaravone / Furosemide Alone).|LS Mean Ratio|1.08|||||TWO_SIDED|90.0|0.96|1.23||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.23|0.96|
73806434|NCT04481789|147161934|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 1 Hour After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.842|||||TWO_SIDED|90.0|0.697|1.017||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.017|0.697|
73806435|NCT04481789|147161934|OTHER|Estimated difference in least squares means and corresponding 90% CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 4 Hours After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.737|||||TWO_SIDED|90.0|0.61|0.891||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.891|0.610|
73806436|NCT04481789|147161935|OTHER|Estimated difference in least squares means and corresponding 90% CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 1 Hour After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.657|||||TWO_SIDED|90.0|0.379|1.137||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.137|0.379|
73806437|NCT04481789|147161935|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 4 Hours After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.522|||||TWO_SIDED|90.0|0.301|0.903||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.903|0.301|
73806438|NCT00943150|147161948|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
73806439|NCT00943150|147161949|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANOVA|||CD3+ at 0 weeks||||0.33
73806440|NCT00943150|147161949|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||CD3+ at 3 weeks||||0.02
73806441|NCT00943150|147161949|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||ANOVA|||CD3+ at 6 weeks||||0.71
73806442|NCT00943150|147161949|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||CD68+ at 0 weeks||||0.67
73806443|NCT00943150|147161949|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||CD68+ at 3 weeks||||0.01
73806444|NCT00943150|147161949|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||ANOVA|||CD68+ at 6 weeks||||0.48
73806445|NCT00943150|147161950|SUPERIORITY_OR_OTHER|||||||0.1128||95.0|||||Exact Wilcoxon rank-sum test|||||||0.1128
73806446|NCT00943150|147161951|SUPERIORITY_OR_OTHER|||||||0.0898||95.0|||||Exact Wilcoxon test|||||||0.0898
73806447|NCT00943150|147161952|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||Exact Wilcoxon test|||Intraoperative narcotic use comparison||||0.0760
73806448|NCT00943150|147161952|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Exact Wilcoxon test|||Postoperative narcotic use comparison||||0.5900
73806449|NCT00943150|147161953|SUPERIORITY_OR_OTHER|||||||0.4589||95.0|||||Exact Wilcoxon test|||||||0.4589
73806450|NCT00943150|147161954|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Exact Wilcoxon test|||||||0.999
73806451|NCT00943150|147161955|SUPERIORITY_OR_OTHER|||||||0.0412||95.0|||||Exact Wilcoxon test|||||||0.0412
73806452|NCT03139578|147161987|NON_INFERIORITY|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|1.18|||||TWO_SIDED|95.0|0.46|3.06|||Generalized linear mixed model|Simulation-based adjustment was utilized to address the multiple comparisons of different base curves.|Cumulative odds ratio was calculated as Test over Control.|||3.06|0.46|
73806453|NCT03139578|147161987|NON_INFERIORITY|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|0.93|||||TWO_SIDED|95.0|0.34|2.52|||Generalized linear mixed model|Simulation-based adjustment was utilized to address the multiple comparisons of different base curves.|Cumulative odds ratio was calculated as Test over Control.|||2.52|0.34|
73806454|NCT03139578|147161988|EQUIVALENCE|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|93.8|||||TWO_SIDED|97.5|81.1|98.1|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||98.1|81.1|
73806455|NCT03139578|147161988|EQUIVALENCE|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|83.3|||||TWO_SIDED|97.5|68.3|92.1|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||92.1|68.3|
73806456|NCT03139578|147161988|EQUIVALENCE|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||TWO_SIDED|97.5|90.5|100.0|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||100|90.5|
73806457|NCT03139578|147161988|EQUIVALENCE|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||TWO_SIDED|97.5|90.5|100.0|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||100.0|90.5|
73806458|NCT03139578|147161989|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.7|-0.3|
73806459|NCT03139578|147161989|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.5|
73806460|NCT03139578|147161990|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.3|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.3|-0.4|
73806461|NCT03139578|147161990|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.2|
73806462|NCT03139578|147161991|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.4|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.4|-0.1|
73806463|NCT03139578|147161991|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.3|-0.2|
73806464|NCT03139578|147161992|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.5|
73806465|NCT03139578|147161992|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.6|0.4|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.4|-0.6|
73806466|NCT03139578|147161993|NON_INFERIORITY|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.002|||||TWO_SIDED|95.0|-0.009|0.012|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.012|-0.009|
73806467|NCT03139578|147161993|NON_INFERIORITY|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.001|||||TWO_SIDED|95.0|-0.012|0.009|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.009|-0.012|
73806468|NCT02477332|147161994|SUPERIORITY||Estimated target dose|32.5|||<|0.05|TWO_SIDED|60.0|27.5|42.5|||Regression, Logistic|Target dose was based on this estimated dose response. The 60% CI included the 20 - 80th percentile of target dose estimated in the bootstrap samples.|Min dose with effect size \>15%|||42.5|27.5|<.05
73806469|NCT02549287|147162007|SUPERIORITY||Odds Ratio, log|0.55||||0.12|TWO_SIDED|95.0|-0.11|1.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.20|-0.11|0.12
73806470|NCT02549287|147162008|SUPERIORITY||Odds Ratio, log|0.41||||0.14|TWO_SIDED|95.0|-0.2|1.03||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.03|-0.20|0.14
73806471|NCT02549287|147162009|SUPERIORITY||Odds Ratio, log|0.44||||0.2|TWO_SIDED|95.0|-0.2|1.07||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.07|-0.20|0.20
73806472|NCT02549287|147162010|SUPERIORITY||Odds Ratio, log|-0.07||||0.77|TWO_SIDED|95.0|-0.58|0.43||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.43|-0.58|0.77
73806473|NCT02549287|147162011|SUPERIORITY||Odds Ratio, log|0.35||||0.29|TWO_SIDED|95.0|-0.27|0.97|||Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.97|-0.27|0.29
73806474|NCT02549287|147162012|SUPERIORITY||Odds Ratio, log|0.49||||0.15|TWO_SIDED|95.0|-0.08|1.06||Other \[Marginal Model (e.g., GEE)\]|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.06|-0.08|0.15
73806475|NCT02549287|147162013|SUPERIORITY||Odds Ratio, log|-0.11||||0.61|TWO_SIDED|95.0|-0.73|0.52||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.52|-0.73|0.61
73806476|NCT02549287|147162014|SUPERIORITY||Odds Ratio, log|-0.22||||0.47|TWO_SIDED|95.0|-0.76|0.32||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.32|-0.76|0.47
73806477|NCT02549287|147162015|SUPERIORITY||Slope|-0.75||||0.65|TWO_SIDED|95.0|-3.7|2.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||2.20|-3.70|0.65
73806478|NCT02549287|147162016|SUPERIORITY||Odds Ratio, log|0.05||||0.64|TWO_SIDED|95.0|-0.59|0.69||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.69|-0.59|0.64
73806479|NCT02549287|147162017|SUPERIORITY||Odds Ratio, log|-0.25||||0.44|TWO_SIDED|95.0|-0.79|0.29||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.29|-0.79|0.44
73806480|NCT02549287|147162018|SUPERIORITY||Odds Ratio, log|0.25||||0.47|TWO_SIDED|95.0|-0.39|0.89||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.89|-0.39|0.47
73806481|NCT02549287|147162019|SUPERIORITY||Slope|-0.18||||0.63|TWO_SIDED|95.0|-3.57|3.22||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||3.22|-3.57|0.63
73806482|NCT03793842|147162020|EQUIVALENCE|Equivalence margin 1 J/min||||||0.002|||||||t-test, 2 sided|||||||.002
73806483|NCT03793842|147162021|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
73806484|NCT03793842|147162022|EQUIVALENCE|Equivalence margin 1 cm H20|Mean Difference (Net)|0.05||||0.006|TWO_SIDED||||||t-test, 2 sided|||||||0.006
73806485|NCT03793842|147162023|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
73806486|NCT03793842|147162024|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
73806487|NCT00596817|147162101|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01||||0.0035|TWO_SIDED|95.0|1.26|3.21|||Cox-model|Cox-model using an exact method to handle ties||||3.21|1.26|0.0035
73806488|NCT00596817|147162102|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.001|TWO_SIDED|95.0|1.35|3.23||A nominal p-value is provided.|Cox-Model|||||3.23|1.35|0.0010
73806489|NCT00596817|147162103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|0.66||0.002|TWO_SIDED|95.0|-3.36|-0.77||A nominal p-value is provided.|ANCOVA|||||-0.77|-3.36|0.0020
73806490|NCT00596817|147162104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|0.55||0.0171|TWO_SIDED|95.0|-2.39|-0.24||A nominal p-value is provided.|ANCOVA|||||-0.24|-2.39|0.0171
73806491|NCT00596817|147162105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.6||0.0612|TWO_SIDED|95.0|-2.3|0.05||A nominal p-value is provided.|ANCOVA|||||0.05|-2.30|0.0612
73806492|NCT00596817|147162106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.57|-0.18||A nominal p-value is provided.|ANCOVA|||||-0.18|-0.57|0.0002
73806493|NCT00596817|147162107|SUPERIORITY_OR_OTHER||Difference|6.35||||0.025|TWO_SIDED|95.0|1.13|11.56||A nominal p-value is provided.|Fisher Exact|||||11.56|1.13|0.025
73806494|NCT00596817|147162108|SUPERIORITY_OR_OTHER||Difference|12.13||||0.002|TWO_SIDED|95.0|4.73|19.52||A nominal p-value is provided.|Fisher Exact|||||19.52|4.73|0.002
73806495|NCT00596817|147162109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.73||0.3642|TWO_SIDED|95.0|-2.12|0.78||A nominal p-value is provided.|ANCOVA|||||0.78|-2.12|0.3642
73806496|NCT00869622|147162111|SUPERIORITY_OR_OTHER|||||||0.0229|TWO_SIDED||||||Fisher Exact|||||||0.0229
73806497|NCT05406479|147162152|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|-0.193|||||TWO_SIDED|95.0|-5.146|4.76||||||Adults||4.76|-5.146|
73806498|NCT05406479|147162152|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|10.556|||||TWO_SIDED|95.0|0.926|20.185||||||Adolescents (13-17)||20.185|0.926|
73895560|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34||||0.004|TWO_SIDED|95.0|-3.91|-0.76|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 44||-0.76|-3.91|0.004
73806499|NCT05406479|147162152|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|2.076|||||TWO_SIDED|95.0|-3.374|7.525||||||Children (5-12)||7.525|-3.374|
73806500|NCT01057810|147162184|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.3667|TWO_SIDED|95.87|0.88|1.39|||Log Rank||Hazard ratio = ipilimumab over placebo|||1.39|0.88|0.3667
73806501|NCT01057810|147162185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.55|0.8|||||HR = ipilimumab over placebo|||0.80|0.55|
73806502|NCT01057810|147162186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.87|0.52|0.83|||||HR = Ipilimumab over placebo|||0.83|0.52|
73806503|NCT01057810|147162187|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.87|0.71|1.35|||||HR = Ipilimumab over placebo|||1.35|0.71|
73806504|NCT02088905|147162191|SUPERIORITY|||||||0.08||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of ECBI Problem Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.080
73806505|NCT02088905|147162191|SUPERIORITY|||||||0.026||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of ECBI Intensity Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.026
73806506|NCT02088905|147162191|OTHER|Type III Tests of Fixed Effects|||||<|0.001||||||Mixed Model Analysis - Significance of Timepoint within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||<.001
73806507|NCT02088905|147162191|OTHER|Type III Tests of Fixed Effects||||||0.182||||||Mixed Model Analysis - Significance of Treatment Assignment within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||.182
73806508|NCT02088905|147162191|OTHER|Type III Tests of Fixed Effects||||||0.015||||||Mixed Model Analysis - Significance of Treatment Assignment and Timepoint Interaction Term within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||.015
73806509|NCT02088905|147162192|SUPERIORITY|||||||0.203||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Parental Distress between Week 18 scores, 1 sided test for Treatment Group Superiority||||.203
73806510|NCT02088905|147162192|SUPERIORITY|||||||0.17||||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of PSI Parent-Child Dysfunctional Interaction between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.17
73806511|NCT02088905|147162192|SUPERIORITY|||||||0.308||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Difficult Child between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.308
73806512|NCT02088905|147162192|SUPERIORITY|||||||0.413||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of PSI Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.413
73806513|NCT02088905|147162194|SUPERIORITY|||||||0.271||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.271
73806514|NCT02088905|147162194|SUPERIORITY|||||||0.434||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Awareness Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.434
73806515|NCT02088905|147162194|SUPERIORITY|||||||0.298||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Cognition Scores between Week 18 scores, 1 sided test for Treatment Group Superiority||||.298
73806516|NCT02088905|147162194|SUPERIORITY|||||||0.294||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Communication Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.294
73806517|NCT02088905|147162194|SUPERIORITY|||||||0.441||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Motivation between Week 18 scores, 1 sided test for Treatment Group Superiority||||.441
73806518|NCT02088905|147162194|SUPERIORITY|||||||0.204||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Restricted and Repetitive Behavior Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.204
73806519|NCT02088905|147162196|SUPERIORITY||||||<|0.001||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of DPICS Negative Skills between Week 18 scores, 1 sided test for Treatment Group Superiority||||<.001
73806520|NCT02088905|147162196|SUPERIORITY||||||<|0.001||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of DPICS Positive Skills between Week 18 scores, 1 sided test for Treatment Group Superiority. Data transformed using a square root transformation.||||<.001
73806521|NCT01222520|147162214|SUPERIORITY_OR_OTHER||Least square mean difference|9.14|||<|0.0001||95.0|7.09|11.18|||ANCOVA|||||11.18|7.09|<0.0001
73806522|NCT01222520|147162215|SUPERIORITY_OR_OTHER||Least square mean difference|14.88|||<|0.0001||95.0|11.82|17.94|||ANCOVA|||||17.94|11.82|<0.0001
73806523|NCT01222520|147162216|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73806524|NCT01222520|147162217|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73806525|NCT01222520|147162218|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73806526|NCT01222520|147162219|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73806527|NCT01222520|147162220|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73806528|NCT01089608|147162226|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.01||||0.072|TWO_SIDED|95.0|-16.3|0.28|||Mixed Models Analysis|||||0.28|-16.30|0.072
73806529|NCT04606394|147162252|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.33|TWO_SIDED||||||Chi-squared|||Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.||||0.33
73806530|NCT04606394|147162253|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.04|TWO_SIDED||||||Chi-squared|||Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.||||0.04
73806531|NCT00955955|147162255|SUPERIORITY_OR_OTHER||Mean Score Reduction|-5.6|STANDARD_DEVIATION|5.7||0.05||95.0|||||SPCD|Sequential Parallel Comparison Design (SPCD)|These results reflect the mean score reduction for the pooled Deplin sample.|Hypothesis 1: There will be a statistically significant difference between the two groups in the degree of improvement, as measured by the change in the 17-item Hamilton Depression Rating Scale (HAM-D-17) score from baseline to endpoint, using the sequential parallel comparison design \[51\]; with a greater degree of reduction in HAM-D-17 scores in the 6(S)-5-MTHF 15 mg qd group than in the placebo group, with the change on placebo being estimated from Trials 1 and 2.||||.05
73806532|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|Geometric Mean Titer (GMT) Ratio|0.69|||||TWO_SIDED|95.0|0.46|1.04|||||Analysis of variance (ANOVA) model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.04|0.46|
73806533|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.6|1.38|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.38|0.60|
73806534|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.63|||||TWO_SIDED|95.0|0.41|0.96|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||0.96|0.41|
73806535|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.98|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.71|0.98|
73806536|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.67|||||TWO_SIDED|95.0|0.51|0.88|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||0.88|0.51|
73806537|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.15|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.15|0.65|
73806538|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.27|||||TWO_SIDED|95.0|0.91|1.78|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.78|0.91|
73806539|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.68|1.33|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.33|0.68|
73806540|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.87|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.71|0.87|
73806541|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.82|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||0.82|0.46|
73806542|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.22|2.17|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||2.17|1.22|
73806543|NCT03423173|147162257|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.75|1.35|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.35|0.75|
73806544|NCT03423173|147162258|OTHER||Seropositivity Rates Difference|0.6|||||TWO_SIDED|95.0|-4.99|6.06|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||6.06|-4.99|
73806545|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|-1.65|||||TWO_SIDED|95.0|-6.9|3.19|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||3.19|-6.90|
73806546|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|-2.25|||||TWO_SIDED|95.0|-7.45|2.69|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||2.69|-7.45|
73806547|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|7.87|||||TWO_SIDED|95.0|0.64|15.3|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||15.30|0.64|
73806548|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|1.5|||||TWO_SIDED|95.0|-4.67|7.65|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||7.65|-4.67|
73895561|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.58||||0.002|TWO_SIDED|95.0|-4.19|-0.97|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 52||-0.97|-4.19|0.002
73806549|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|-6.37|||||TWO_SIDED|95.0|-14.0|1.04|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||1.04|-14.00|
73806550|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|0.72|||||TWO_SIDED|95.0|-3.87|5.29|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||5.29|-3.87|
73806551|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|-0.83|||||TWO_SIDED|95.0|-5.24|3.17|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||3.17|-5.24|
73806552|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|-1.55|||||TWO_SIDED|95.0|-6.05|2.58|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||2.58|-6.05|
73806553|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|2.42|||||TWO_SIDED|95.0|-2.12|7.44|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||7.44|-2.12|
73806554|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|0.83|||||TWO_SIDED|95.0|-3.41|5.24|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||5.24|-3.41|
73806555|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|-1.59|||||TWO_SIDED|95.0|-6.67|3.17|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||3.17|-6.67|
73806556|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|2.93|||||TWO_SIDED|95.0|-3.07|9.06|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||9.06|-3.07|
73806557|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|-0.81|||||TWO_SIDED|95.0|-6.17|4.44|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||4.44|-6.17|
73806558|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|-3.73|||||TWO_SIDED|95.0|-9.74|2.03|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||2.03|-9.74|
73895562|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.368|TWO_SIDED|95.0|-1.13|0.42|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 28||0.42|-1.13|0.368
73806559|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|6.79|||||TWO_SIDED|95.0|-1.03|14.56|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||14.56|-1.03|
73806560|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|3.0|||||TWO_SIDED|95.0|-4.28|10.23|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||10.23|-4.28|
73806561|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|-3.79|||||TWO_SIDED|95.0|-11.97|4.39|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||4.39|-11.97|
73806562|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|-2.5|||||TWO_SIDED|95.0|-7.68|1.55|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||1.55|-7.68|
73806563|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|0.04|||||TWO_SIDED|95.0|-5.47|5.62|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||5.62|-5.47|
73806564|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|2.54|||||TWO_SIDED|95.0|-1.52|7.81|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||7.81|-1.52|
73806565|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|-1.52|||||TWO_SIDED|95.0|-9.14|5.69|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||5.69|-9.14|
73806566|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|1.13|||||TWO_SIDED|95.0|-6.9|8.95|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||8.95|-6.90|
73806567|NCT03423173|147162258|OTHER||Seropositivity Rate Difference|2.64|||||TWO_SIDED|95.0|-4.68|10.18|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||10.18|-4.68|
73806568|NCT03423173|147162259|OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.56|1.42|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.42|0.56|
73806569|NCT03423173|147162259|OTHER||GMT Ratio|0.81|||||TWO_SIDED|95.0|0.51|1.28|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.28|0.51|
73806570|NCT03423173|147162259|OTHER||GMT Ratio|0.73|||||TWO_SIDED|95.0|0.46|1.16|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.16|0.46|
73806571|NCT03423173|147162259|OTHER||GMT Ratio|1.37|||||TWO_SIDED|95.0|1.02|1.86|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.86|1.02|
73806572|NCT03423173|147162259|OTHER||GMT Ratio|0.65|||||TWO_SIDED|95.0|0.48|0.87|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||0.87|0.48|
73895563|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.208|TWO_SIDED|95.0|-1.46|0.32|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 36||0.32|-1.46|0.208
73895564|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.064|TWO_SIDED|95.0|-1.73|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 44||0.05|-1.73|0.064
73806573|NCT03423173|147162259|OTHER||GMT ratio|0.89|||||TWO_SIDED|95.0|0.66|1.21|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.21|0.66|
73806574|NCT03423173|147162259|OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.0|1.94|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.94|1.00|
73806575|NCT03423173|147162259|OTHER||GMT Ratio|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.21|0.64|
73806576|NCT03423173|147162259|OTHER||GMT Ratio|1.23|||||TWO_SIDED|95.0|0.88|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.71|0.88|
73806577|NCT03423173|147162259|OTHER||GMT Ratio|0.83|||||TWO_SIDED|95.0|0.58|1.18|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.18|0.58|
73806578|NCT03423173|147162259|OTHER||GMT Ratio|1.51|||||TWO_SIDED|95.0|1.07|2.14|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||2.14|1.07|
73806579|NCT03423173|147162259|OTHER||GMT Ratio|1.25|||||TWO_SIDED|95.0|0.88|1.78|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.78|0.88|
73806580|NCT03852264|147162265|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|2.61|||||TWO_SIDED|90.0|-1.29|6.38|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||6.38|-1.29|
73895565|NCT01578850|147324504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.081|TWO_SIDED|95.0|-1.66|0.1|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 52||0.10|-1.66|0.081
73895566|NCT01578850|147324506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.005|TWO_SIDED|95.0|-0.9|-0.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-0.16|-0.90|0.005
73806581|NCT03852264|147162265|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|1.62|||||TWO_SIDED|90.0|-2.18|5.45|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||5.45|-2.18|
73806582|NCT03852264|147162265|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-1.0|||||TWO_SIDED|90.0|-4.93|2.83|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||2.83|-4.93|
73806583|NCT03852264|147162266|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|0.3482|||||TWO_SIDED|90.0|-0.476|1.211|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||1.211|-0.476|
73806584|NCT03852264|147162266|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-0.0635|||||TWO_SIDED|90.0|-0.931|0.803|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||0.803|-0.931|
73806585|NCT03852264|147162266|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-0.422|||||TWO_SIDED|90.0|-1.319|0.445|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||0.445|-1.319|
73806586|NCT03852264|147162267|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|0.468|||||TWO_SIDED|90.0|-101.0|99.5|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||99.5|-101|
73806587|NCT03852264|147162267|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-115.0|||||TWO_SIDED|90.0|-225.0|-15.5|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||-15.5|-225|
73806588|NCT03852264|147162267|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-115.48|||||TWO_SIDED|90.0|-223.0|-16.2|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||-16.2|-223|
73806589|NCT01631149|147162276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_DEVIATION|0.4|<|0.001|||||||t-test, 2 sided|||"The individual scores obtained during surgery were averaged.~The average values were compared using a t-test between treatments."||||<0.001
73806590|NCT02217410|147162284|OTHER||Mean Difference (Final Values)|0.095||||0.8976|TWO_SIDED|95.0|-0.067|0.263|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 3|||0.263|-0.067|0.8976
73806591|NCT02217410|147162284|OTHER||Mean Difference (Final Values)|0.093||||0.8836|TWO_SIDED|95.0|-0.084|0.271|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 6|||0.271|-0.084|0.8836
73806592|NCT02217410|147162284|OTHER||Mean Difference (Final Values)|0.093||||0.8822|TWO_SIDED|95.0|-0.085|0.272|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 9|||0.272|-0.085|0.8822
73806593|NCT02217410|147162284|OTHER||Mean Difference (Final Values)|0.093||||0.8821|TWO_SIDED|95.0|-0.087|0.273|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 12|||0.273|-0.087|0.8821
73895567|NCT01578850|147324506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.001|TWO_SIDED|95.0|-1.18|-0.38|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-0.38|-1.18|<0.001
73895568|NCT01578850|147324506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||<|0.001|TWO_SIDED|95.0|-1.35|-0.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-0.54|-1.35|<0.001
73806594|NCT00637000|147162298|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|The statistical method used was a group by time repeated measures model with a first-order autoregressive covariance structure||To test the primary study hypothesis that neither soluble film formulation would precipitate an opioid withdrawal syndrome, peak COWS score in the 23.5 hour period after the initial soluble film administration were compared to pre-administration baseline COWS scores (30 minutes prior to soluble film administration) using a group by time repeated measures model with a first-order autoregressive covariance structure.||||<0.0001
73806595|NCT00637000|147162299|SUPERIORITY_OR_OTHER|||||||0|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.000
73806596|NCT00637000|147162300|SUPERIORITY_OR_OTHER|||||||0.035||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.035
73806597|NCT00637000|147162301|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
73806598|NCT00637000|147162302|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
73806599|NCT00637000|147162303|SUPERIORITY_OR_OTHER|||||||0.006||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.006
73806600|NCT00637000|147162304|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
73806601|NCT00637000|147162305|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
73806602|NCT00637000|147162306|SUPERIORITY_OR_OTHER|||||||0.762||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.762
73806603|NCT00637000|147162307|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
73806604|NCT00637000|147162308|SUPERIORITY_OR_OTHER|||||||0.349||||||The p-value is not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.349
73806605|NCT00637000|147162309|SUPERIORITY_OR_OTHER|||||||0.028||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.028
73895569|NCT01578850|147324506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.001|TWO_SIDED|95.0|-1.33|-0.53|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-0.53|-1.33|<0.001
73806606|NCT00637000|147162310|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
73806607|NCT00637000|147162311|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
73806608|NCT00637000|147162312|SUPERIORITY_OR_OTHER|||||||0.117||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.117
73806609|NCT00637000|147162313|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
73806610|NCT00637000|147162314|SUPERIORITY_OR_OTHER|||||||0.238||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.238
73806611|NCT02751450|147162321|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.882|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||-0.882|-1.150|<0.0001
73806612|NCT01290679|147162325|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|32.2|||<|0.001|TWO_SIDED|95.0|23.3|41.2|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR12 between the treatment groups.||41.2|23.3|<0.001
73806613|NCT01290679|147162326|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|29.3|||<|0.001|TWO_SIDED|95.0|20.2|38.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVRW72 between the treatment groups.||38.5|20.2|<0.001
73806614|NCT01290679|147162327|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|31.5|||<|0.001|TWO_SIDED|95.0|22.5|40.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR24 between the treatment groups.||40.5|22.5|<0.001
73806615|NCT01290679|147162328|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|32.3|||<|0.001|TWO_SIDED|95.0|23.5|41.0|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR4 between the treatment groups.||41.0|23.5|<0.001
73806616|NCT01290679|147162355|SUPERIORITY_OR_OTHER||Mean differences|-16.776|STANDARD_ERROR_OF_MEAN|6.3081||0.008|TWO_SIDED|95.0|-29.1502|-4.4025|||Piecewise Linear Model|||Fatigue Severity Score AUC60||-4.4025|-29.1502|0.008
73806617|NCT01290679|147162355|SUPERIORITY_OR_OTHER||Mean differences|-18.837|STANDARD_ERROR_OF_MEAN|7.4715||0.012|TWO_SIDED|95.0|-33.4933|-4.1801|||Piecewise Linear Model|||Fatigue Severity Score AUC72||-4.1801|-33.4933|0.012
73895570|NCT01578850|147324508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.048|TWO_SIDED|95.0|-1.0|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-0.01|-1.00|0.048
73895571|NCT01578850|147324508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.001|TWO_SIDED|95.0|-1.44|-0.43|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-0.43|-1.44|<0.001
73806618|NCT01290679|147162356|SUPERIORITY_OR_OTHER||Mean differences|-282.16|STANDARD_ERROR_OF_MEAN|105.4927||0.008|TWO_SIDED|95.0|-489.1252|-75.1949|||Piecewise Linear Model|||Impairment in Work Productivity AUC60||-75.1949|-489.1252|0.008
73806619|NCT01290679|147162356|SUPERIORITY_OR_OTHER||Mean differences|-324.363|STANDARD_ERROR_OF_MEAN|124.026||0.009|TWO_SIDED|95.0|-567.708|-81.0182|||Piecewise Linear Model|||Impairment in Work Productivity AUC72||-81.0182|-567.7080|0.009
73806620|NCT01290679|147162357|SUPERIORITY_OR_OTHER||Mean Differences|-282.436|STANDARD_ERROR_OF_MEAN|104.9894||0.007|TWO_SIDED|95.0|-488.415|-76.4566|||Piecewise linear model|||Impairment in Daily Activities AUC60||-76.4566|-488.4150|0.007
73806621|NCT01290679|147162357|SUPERIORITY_OR_OTHER||Mean differences|-329.204|STANDARD_ERROR_OF_MEAN|123.408||0.008|TWO_SIDED|95.0|-571.3389|-87.0695|||Piecewise Linear Model|||Impairment in Daily Activities AUC72||-87.0695|-571.3389|0.008
73806622|NCT01290679|147162358|SUPERIORITY_OR_OTHER||Mean differences|-186.852|STANDARD_ERROR_OF_MEAN|121.4741||0.125|TWO_SIDED|95.0|-425.4109|51.7059|||Piecewise linear model|||Time Missed from Work AUC60||51.7059|-425.4109|0.125
73806623|NCT01290679|147162358|SUPERIORITY_OR_OTHER||Mean differences|-188.202|STANDARD_ERROR_OF_MEAN|141.1702||0.183|TWO_SIDED|95.0|-465.507|89.104|||Piecewise linear model|||Time Missed from Work AUC72||89.1040|-465.5070|0.183
73806624|NCT03315286|147162372|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
73806625|NCT03315286|147162373|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
73806626|NCT03315286|147162374|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Baseline results are reported here.||||0.6
73806627|NCT03315286|147162374|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||6 month data is reported here||||0.3
73806628|NCT03315286|147162375|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Baseline data is reported here.||||0.2
73806629|NCT03315286|147162375|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||6 month data is reported here||||0.4
73806630|NCT03315286|147162376|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||baseline data is reported here||||0.07
73806631|NCT03315286|147162376|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||6 month data is reported here||||0.0002
73806632|NCT03075891|147162378|SUPERIORITY|||||||0.032|||||||Cochran-Mantel-Haenszel|||||||0.032
73806633|NCT00828568|147162406|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence limit around the difference in proportion of patients considered a Treatment Success between test and reference products was calculated using Blackwelder's method with Yate's continuity correction. If the 90% confidence interval for the test to reference ratio for the primary endpoint was within -0.20 to +0.20, then the test product would have been declared therapeutically equivalent to the reference product.|Mean Difference (Final Values)|4.85||||||90.0|-5.37|15.08||||||||15.08|-5.37|
73806634|NCT00828568|147162408|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
73806635|NCT00828568|147162408|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<.0001
73806636|NCT01075256|147162496|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.1||||0.3628|TWO_SIDED|95.0|-6.7|2.46||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no diference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||2.46|-6.70|0.3628
73895572|NCT01578850|147324508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.001|TWO_SIDED|95.0|-1.33|-0.33|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-0.33|-1.33|0.001
73806637|NCT01075256|147162496|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2||||0.9361|TWO_SIDED|95.0|-4.45|4.83||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||4.83|-4.45|0.9361
73806638|NCT01075256|147162496|SUPERIORITY_OR_OTHER||Adjusted Mean difference|2.3||||0.3257|TWO_SIDED|95.0|-2.31|6.92||No adustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.92|-2.31|0.3257
73806639|NCT01075256|147162497|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0||||0.6674|TWO_SIDED|95.0|-5.73|3.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||3.68|-5.73|0.6674
73806640|NCT01075256|147162497|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9888|TWO_SIDED|95.0|-4.74|4.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is the high concentration minus placebo such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||4.81|-4.74|0.9888
73895573|NCT01578850|147324508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.002|TWO_SIDED|95.0|-1.33|-0.31|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-0.31|-1.33|0.002
73895574|NCT01578850|147324510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.11||||0.033|TWO_SIDED|95.0|-27.07|-1.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-1.16|-27.07|0.033
73895575|NCT01578850|147324510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.04||||0.013|TWO_SIDED|95.0|-30.39|-3.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-3.68|-30.39|0.013
73895576|NCT01578850|147324510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.54||||0.019|TWO_SIDED|95.0|-30.35|-2.73|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-2.73|-30.35|0.019
73895577|NCT01578850|147324510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.66||||0.007|TWO_SIDED|95.0|-33.78|-5.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-5.54|-33.78|0.007
73895578|NCT01578850|147324512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.21||||0.078|TWO_SIDED|95.0|-8.91|0.48|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 28||0.48|-8.91|0.078
73895579|NCT01578850|147324512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.54||||0.003|TWO_SIDED|95.0|-12.49|-2.59|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 36||-2.59|-12.49|0.003
73895580|NCT01578850|147324512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.19||||0.001|TWO_SIDED|95.0|-13.2|-3.18|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 44||-3.18|-13.20|0.001
73895581|NCT01578850|147324512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.001|TWO_SIDED|95.0|-13.64|-3.55|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 52||-3.55|-13.64|<0.001
73895582|NCT01578850|147324512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.91||||0.017|TWO_SIDED|95.0|-10.75|-1.06|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 28||-1.06|-10.75|0.017
73895583|NCT01578850|147324512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.001|TWO_SIDED|95.0|-13.85|-3.34|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 36||-3.34|-13.85|0.001
73895584|NCT01578850|147324512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.49|||<|0.001|TWO_SIDED|95.0|-14.72|-4.26|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 44||-4.26|-14.72|<0.001
73806641|NCT01075256|147162497|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1||||0.6599|TWO_SIDED|95.0|-3.69|5.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||5.81|-3.69|0.6599
73895585|NCT01578850|147324512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.29|||<|0.001|TWO_SIDED|95.0|-14.6|-3.99|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 52||-3.99|-14.60|<0.001
73895586|NCT01578850|147324514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.22||||0.014|TWO_SIDED|95.0|-9.39|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 28||-1.05|-9.39|0.014
73895587|NCT01578850|147324514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27||||0.011|TWO_SIDED|95.0|-11.09|-1.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 36||-1.46|-11.09|0.011
73895588|NCT01578850|147324514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|||<|0.001|TWO_SIDED|95.0|-12.06|-3.44|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 44||-3.44|-12.06|<0.001
73895589|NCT01578850|147324514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.16||||0.001|TWO_SIDED|95.0|-11.48|-2.85|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 52||-2.85|-11.48|0.001
73895590|NCT01578850|147324514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.86|||<|0.001|TWO_SIDED|95.0|-9.23|-2.49|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 28||-2.49|-9.23|<0.001
73895591|NCT01578850|147324514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.69|||<|0.001|TWO_SIDED|95.0|-12.33|-5.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 36||-5.05|-12.33|<0.001
73895592|NCT01578850|147324514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59|||<|0.001|TWO_SIDED|95.0|-11.38|-3.8|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 44||-3.80|-11.38|<0.001
73895593|NCT01578850|147324514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.32|||<|0.001|TWO_SIDED|95.0|-10.03|-2.6|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 52||-2.60|-10.03|<0.001
73895594|NCT01711216|147324532|SUPERIORITY_OR_OTHER|||||||0.3181|TWO_SIDED|||||Test statistic (d.f.) 1.0157 (1) A Mantel-Haenszel chi-square test was used, exact p-value was computed using Monte Carlo estimation.|Mantel Haenszel|||Test of association between the number of regular menstrual cycles during the follow-up period and the number of dydrogesterone therapy cycles received during the treatment period (Follow-up Analysis Set) Follow-up Analysis Set (N=915)||||0.3181
73895595|NCT02744040|147324595|OTHER|||||||0.048||||||Multiple hypothesis testing was performed using Tukey's Honest Significant Difference (HSD) procedure.|Mixed Effects Models|||Total HIV DNA at the time of ART initiation in each of the three EDDI groups||||0.048
73806642|NCT01075256|147162498|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1||||0.9759|TWO_SIDED|95.0|-6.34|6.54||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.54|-6.34|0.9759
73895596|NCT02744040|147324596|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
73895597|NCT02744040|147324596|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
73895598|NCT02744040|147324596|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
73895599|NCT02744040|147324596|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
73895600|NCT02744040|147324596|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
73895601|NCT02744040|147324596|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
73895602|NCT02744040|147324597|OTHER||||||>|0.05||||||Multiple hypothesis testing was performed using Tukey's HSD procedure.|Mixed Effects Models|||Integrated HIV DNA at the time of ART initiation in each of the three EDDI groups||||>0.05
73895603|NCT02744040|147324598|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
73895604|NCT02744040|147324598|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
73895605|NCT02744040|147324598|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
73895606|NCT02744040|147324598|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
73895607|NCT02744040|147324598|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
73806643|NCT01075256|147162498|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5||||0.8903|TWO_SIDED|95.0|-6.97|6.06||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.06|-6.97|0.8903
73806644|NCT01075256|147162498|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6||||0.8662|TWO_SIDED|95.0|-7.04|5.93||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.||5.93|-7.04|0.8662
73806645|NCT01075256|147162499|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6||||0.8419|TWO_SIDED|95.0|-6.93|5.66||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||5.66|-6.93|0.8419
73806646|NCT01075256|147162499|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3||||0.9147|TWO_SIDED|95.0|-6.03|6.72||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.72|-6.03|0.9147
73806647|NCT01075256|147162499|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0||||0.76|TWO_SIDED|95.0|-5.36|7.33||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||7.33|-5.36|0.7600
73806648|NCT01075256|147162500|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.5||||0.9124|TWO_SIDED|95.0|-8.28|9.24||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.24|-8.28|0.9124
73806649|NCT01075256|147162500|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5||||0.9083|TWO_SIDED|95.0|-9.13|8.14||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level||8.14|-9.13|0.9083
73806650|NCT01075256|147162500|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0||||0.8231|TWO_SIDED|95.0|-9.73|7.77||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||7.77|-9.73|0.8231
73895608|NCT02744040|147324598|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
73895609|NCT02744040|147324599|OTHER|||||||0.057||||||Multiple hypothesis testing was performed using Tukey's HSD procedure.|Mixed Effects Models|||TILDA stimulation reservoir measure at the time of ART initiation in each of the three EDDI groups||||0.057
73895610|NCT02744040|147324600|OTHER|Tukey's Honest Significant Difference (HSD) test||||||0.01||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||0.010
73806651|NCT01075256|147162501|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.4||||0.5946|TWO_SIDED|95.0|-9.32|16.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||16.09|-9.32|0.5946
73806652|NCT01075256|147162501|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9944|TWO_SIDED|95.0|-12.51|12.6||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||12.60|-12.51|0.9944
73806653|NCT01075256|147162501|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.3||||0.5998|TWO_SIDED|95.0|-16.06|9.38||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.38|-16.06|0.5998
73806654|NCT01075256|147162502|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2||||0.7952|TWO_SIDED|95.0|-10.51|8.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.09|-10.51|0.7952
73806655|NCT01075256|147162502|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4||||0.601|TWO_SIDED|95.0|-11.56|6.76||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.76|-11.56|0.6010
73806656|NCT01075256|147162502|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2||||0.7976|TWO_SIDED|95.0|-10.48|8.1||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.10|-10.48|0.7976
73806657|NCT01075256|147162503|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.7||||0.906|TWO_SIDED|95.0|-10.38|11.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||11.68|-10.38|0.9060
73806658|NCT01075256|147162503|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.7||||0.7575|TWO_SIDED|95.0|-12.63|9.25||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.25|-12.63|0.7575
73806659|NCT01075256|147162503|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.3||||0.6727|TWO_SIDED|95.0|-13.42|8.73||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.73|-13.42|0.6727
73806660|NCT01218087|147162510|NON_INFERIORITY_OR_EQUIVALENCE|Following the first interim analysis of the first 40 infants, the sample size calculation was revised. A revised sample size of 62 infants (31 per treatment arm) was based on an observed reduction of 41% to 11% in the experimental group with a goal p value of 0.01.||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
73895611|NCT02744040|147324600|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||<0.0001
73895612|NCT02744040|147324600|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
73895613|NCT02744040|147324600|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
73895614|NCT02744040|147324600|OTHER|Tukey's Honest Significant Difference (HSD) test||||||0.052||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||0.052
73895615|NCT02744040|147324600|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
73895616|NCT00096356|147324608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.03||0.1815|TWO_SIDED|95.0|-3.39|0.64||The a priori significance level was 0.05 for the primary outcome; there is no adjustment for multiple comparisons.|Mixed Models Analysis||This is the estimate of the difference in arms (Co-Q10 minus placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance - constrained such that baseline fatigue was the same in both groups and unadjusted for any baseline covariates.||0.64|-3.39|0.1815
73806661|NCT03010800|147162519|SUPERIORITY|||||||0.0469||||||One subject experienced incontinence with the Yoni.Fit in place (#8) (9.2 g Pad Wt. Without and 17.3 g Pad Wt. With). This was attributed to incorrect Yoni.Fit sizing. This subject was not included in the p-value calculation.|Wilcoxon (Mann-Whitney)|||"Null hypothesis is that the pad weights With Yoni.Fit and Without Yoni.Fit are equivalent.~A one-sided Wilcoxson paired T-test of the group means will be performed. If the p-value is significant, the null hypothesis will be rejected."||||0.0469
73806662|NCT01314872|147162520|SUPERIORITY_OR_OTHER||Difference in least squares (LS) means|-0.46||||0.056|TWO_SIDED|95.0|-0.92|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||0.01|-0.92|0.056
73806663|NCT01314872|147162520|SUPERIORITY_OR_OTHER||Difference in LS means|-0.45||||0.064|TWO_SIDED|95.0|-0.93|0.03|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||0.03|-0.93|0.064
73806664|NCT01314872|147162520|SUPERIORITY_OR_OTHER||Difference in LS means|-0.64||||0.007|TWO_SIDED|95.0|-1.11|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.18|-1.11|0.007
73806665|NCT01314872|147162520|SUPERIORITY_OR_OTHER||Difference in LS means|-0.91|||<|0.001|TWO_SIDED|95.0|-1.37|-0.44|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.44|-1.37|< 0.001
73806666|NCT01314872|147162520|SUPERIORITY_OR_OTHER||Difference in LS means|-0.54||||0.026|TWO_SIDED|95.0|-1.02|-0.07|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.07|-1.02|0.026
73806667|NCT01314872|147162525|SUPERIORITY_OR_OTHER||Difference in LS means|-0.28||||0.167|TWO_SIDED|95.0|-0.68|0.12|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.12|-0.68|0.167
73806668|NCT01314872|147162525|SUPERIORITY_OR_OTHER||Difference in LS means|-0.57||||0.005|TWO_SIDED|95.0|-0.97|-0.17|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.17|-0.97|0.005
73806669|NCT01314872|147162525|SUPERIORITY_OR_OTHER||Difference in LS means|-0.72|||<|0.001|TWO_SIDED|95.0|-1.11|-0.33|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.33|-1.11|< 0.001
73806670|NCT01314872|147162525|SUPERIORITY_OR_OTHER||Difference in LS means|-0.71|||<|0.001|TWO_SIDED|95.0|-1.1|-0.32|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.32|-1.10|< 0.001
73806671|NCT01314872|147162525|SUPERIORITY_OR_OTHER||Difference in LS means|-0.46||||0.03|TWO_SIDED|95.0|-0.87|-0.04|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.04|-0.87|0.030
73806672|NCT01314872|147162526|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.18||||0.401|TWO_SIDED|95.0|-0.61|0.25|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.25|-0.61|0.401
73895617|NCT00096356|147324609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|2.31||0.3903|TWO_SIDED|95.0|-2.56|6.53||0.05 significance level; no multiple comparison adjustment|Mixed Models Analysis||This is the difference in treatment groups at 24 weeks (Co-Q10 minus Placebo). Higher is better for this outcome.|Constrained repeated measures analysis of variance - constrained to have equal means at baseline, unadjusted for other covariates||6.53|-2.56|.3903
73806673|NCT01314872|147162526|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48||||0.029|TWO_SIDED|95.0|-0.91|-0.05|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.05|-0.91|0.029
73806674|NCT01314872|147162526|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.005|TWO_SIDED|95.0|-1.02|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.18|-1.02|0.005
73806675|NCT01314872|147162526|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.58||||0.007|TWO_SIDED|95.0|-1.01|-0.16|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.16|-1.01|0.007
73806676|NCT01314872|147162526|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.34||||0.14|TWO_SIDED|95.0|-0.78|0.11|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.11|-0.78|0.140
73806677|NCT01314872|147162527|SUPERIORITY_OR_OTHER||Difference in LS means|-0.18||||0.598|TWO_SIDED|95.0|-0.84|0.49|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.49|-0.84|0.598
73806678|NCT01314872|147162527|SUPERIORITY_OR_OTHER||Difference in LS means|-0.67||||0.052|TWO_SIDED|95.0|-1.35|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.01|-1.35|0.052
73806679|NCT01314872|147162527|SUPERIORITY_OR_OTHER||Difference in LS means|-0.76||||0.024|TWO_SIDED|95.0|-1.43|-0.1|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.10|-1.43|0.024
73806680|NCT01314872|147162527|SUPERIORITY_OR_OTHER||Difference in LS means|-1.24|||<|0.001|TWO_SIDED|95.0|-1.9|-0.58|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.58|-1.90|< 0.001
73806681|NCT01314872|147162527|SUPERIORITY_OR_OTHER||Difference in LS means|-0.94||||0.007|TWO_SIDED|95.0|-1.62|-0.26|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.26|-1.62|0.007
73806682|NCT01314872|147162528|SUPERIORITY_OR_OTHER||Difference in LS means|-0.49|||||TWO_SIDED|95.0|-1.0|0.03||||||||0.03|-1.00|
73806683|NCT01314872|147162528|SUPERIORITY_OR_OTHER||Difference in LS means|-1.1|||||TWO_SIDED|95.0|-1.62|-0.58||||||||-0.58|-1.62|
73806684|NCT01314872|147162529|SUPERIORITY_OR_OTHER||Difference in LS means|-0.29|||||TWO_SIDED|95.0|-0.71|0.13||||||||0.13|-0.71|
73895618|NCT00096356|147324610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.31||0.6014|TWO_SIDED|95.0|-3.25|1.88||0.05 significance level, unadjusted for multiple comparisons|Mixed Models Analysis||This is the difference between treatment groups at 24 weeks (Co-Q10 minus Placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance, constrained such that the baseline means are equal, unadjusted of other covariates||1.88|-3.25|.6014
73895619|NCT00796926|147324616|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||>0.05
73895620|NCT01379508|147324661|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-4.0|||||TWO_SIDED|95.0|-10.5|2.5||||||Missing DNA data at Wk 52=failure: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (\< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (\< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA \< 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference.||2.5|-10.5|
73895621|NCT01379508|147324661|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference was above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.1|||||TWO_SIDED|95.0|-9.4|3.1||||||Imputing +/- 7 days DNA for Wk 52: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (\< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (\< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA \< 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference.||3.1|-9.4|
73895622|NCT01379508|147324661|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.8|||||TWO_SIDED|95.0|-7.9|0.4||||||Imputing LOCF DNA for wk 52: d/c for non response prior to Wk 52: Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with LOCF for other patients||0.4|-7.9|
73895623|NCT01379508|147324661|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-2.3|||||TWO_SIDED|95.0|-8.3|3.8||||||Imputing within +28d DNA for wk52: d/c for non response \<28 days from Wk 52:Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with the earliest available assessment within the 28-day window starting from the scheduled Week 52 date for other patients (if no such assessment is available, treated as failure)||3.8|-8.3|
73895624|NCT04236141|147324675|SUPERIORITY||Difference in Response Rates|10.71|||||TWO_SIDED|95.0|-19.0|40.43||||||||40.43|-19.00|
73895625|NCT04236141|147324676|SUPERIORITY||Difference in Response Rates|7.14|||||TWO_SIDED|95.0|-22.03|36.31||||||||36.31|-22.03|
73806685|NCT01314872|147162529|SUPERIORITY_OR_OTHER||Difference in LS means|-0.21|||||TWO_SIDED|95.0|-0.64|0.21||||||||0.21|-0.64|
73895626|NCT04236141|147324677|SUPERIORITY||Difference in Response Rates|14.29|||||TWO_SIDED|95.0|-15.89|44.46||||||||44.46|-15.89|
73895627|NCT04236141|147324678|SUPERIORITY||Difference in Response Rates|21.43|||||TWO_SIDED|95.0|-9.44|52.3||||||||52.30|-9.44|
73895628|NCT04236141|147324679|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-1.69|37.4||||||||37.40|-1.69|
73895629|NCT04236141|147324680|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-1.69|37.4||||||||37.40|-1.69|
73895630|NCT04236141|147324681|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-12.7|48.42||||||||48.42|-12.70|
73895631|NCT04236141|147324682|SUPERIORITY||Difference in Response Rates|14.29|||||TWO_SIDED|95.0|-15.89|44.46||||||||44.46|-15.89|
73895632|NCT04236141|147324683|SUPERIORITY||Difference in Response Rates|25.0|||||TWO_SIDED|95.0|-10.38|60.38||||||||60.38|-10.38|
73895633|NCT04236141|147324684|SUPERIORITY||Difference in Response Rates|3.57|||||TWO_SIDED|95.0|-33.84|40.98||||||||40.98|-33.84|
73895634|NCT01954927|147324702|SUPERIORITY|||||||0.227||||||1-sided p-value|z-test Proportion|z-test of proportions without continuity correction||||||0.227
73806686|NCT01314872|147162530|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.56|0.43||||||||0.43|-0.56|
73806687|NCT01314872|147162530|SUPERIORITY_OR_OTHER||Difference in LS means|0.02|||||TWO_SIDED|95.0|-0.48|0.51||||||||0.51|-0.48|
73806688|NCT01314872|147162531|SUPERIORITY_OR_OTHER||Difference in LS means|-0.76|||||TWO_SIDED|95.0|-1.45|-0.08||||||||-0.08|-1.45|
73895635|NCT01954927|147324703|SUPERIORITY|||||||0.897|||||||Wilcoxon (Mann-Whitney)|||||||0.897
73895636|NCT01954927|147324704|SUPERIORITY|||||||0.181|||||||Chi-squared|||||||0.181
73895637|NCT01954927|147324705|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.730
73895638|NCT01954927|147324706|SUPERIORITY|||||||0.713|||||||Chi-squared|||||||0.713
73895639|NCT01954927|147324707|SUPERIORITY|||||||0.739|||||||Wilcoxon (Mann-Whitney)|||||||0.739
73895640|NCT01954927|147324708|SUPERIORITY|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||||||0.388
73895641|NCT00955305|147324709|SUPERIORITY_OR_OTHER|||||||0.33||||||one-sided p-value using stratified logrank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors||||||0.33
73895642|NCT00955305|147324710|SUPERIORITY_OR_OTHER|||||||0.95||||||two-sided p-value by stratified log rank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors||||||0.95
73895643|NCT00955305|147324711|SUPERIORITY_OR_OTHER|||||||0.15||||||two sided p-value by Fisher's exact test|Fisher Exact|||||||0.15
73806689|NCT01314872|147162531|SUPERIORITY_OR_OTHER||Difference in LS means|-1.24|||||TWO_SIDED|95.0|-1.93|-0.56||||||||-0.56|-1.93|
73806690|NCT02986282|147162555|OTHER||Median Difference (Final Values)|-0.0600326|||<|0.05|TWO_SIDED|95.0|-0.0799661|-0.0449876|||Wilcoxon (Mann-Whitney)|||It was calculated that the study sample size of 79 subjects would be needed to detect a difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a two-tailed α of 0.05 and a (1-β) of 0.90. Our initial estimate of sample size of 115 patients incorporated an assumption of dropout. Intra-observer variability was calculated using intra-class correlation coefficient.||-0.0449876|-0.0799661|<0.05
73895644|NCT00109590|147324714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P\<0.05.|wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject Cpredose LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum.||||0.009
73895645|NCT00109590|147324714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048||95.0||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P\<0.05.|Wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject C4hour LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum||||0.048
73895646|NCT00745849|147324727|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
73895647|NCT00353470|147324728|SUPERIORITY||shared parameters model|-0.56|STANDARD_ERROR_OF_MEAN|0.29|>|0.16|TWO_SIDED||||||Chi-squared|||Power: to detect a between-group effect size of 0.45, for statistical power of 0.80, 56 patients for PFPP or CBT vs. 28 for ART were required. Response rates at termination were calculated by chi-square in the full ITT sample using LOCF.||||>0.16
73895648|NCT00353470|147324728|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
73895649|NCT03745820|147324774|SUPERIORITY||Least Squares (LS) Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.328|=|0.8472|TWO_SIDED|95.0|-2.88|2.37|||MMRM|||Mixed Model Repeated Measures(MMRM)model was used to analyze change from baseline of outcome measure(OM)using fixed effects of treatment group,region,study visit,study visit-by-treatment interaction,baseline value of OM,baseline-by-visit interaction.||2.37|-2.88|=0.8472
73895650|NCT03745820|147324774|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.323|=|0.8053|TWO_SIDED|95.0|-2.94|2.29|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||2.29|-2.94|=0.8053
73806691|NCT02986282|147162556|OTHER||Median Difference (Final Values)|-0.0249837|||<|0.05|TWO_SIDED|95.0|-0.039992|-0.0100226|||Wilcoxon (Mann-Whitney)|||||-0.0100226|-0.039992|<0.05
73806692|NCT01068730|147162583|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|102.58|||||TWO_SIDED|95.0|99.07|106.23|||||Ratio=Treatment B/Treatment A. Geometric least squares (LS) means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||106.23|99.07|
73895651|NCT03745820|147324778|SUPERIORITY||LS Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|1.835|=|0.0637|TWO_SIDED|95.0|-0.2|7.06|||ANCOVA|||An analysis of covariance (ANCOVA) model was applied adjusting for treatment group and baseline value of the OM.||7.06|-0.20|=0.0637
73806693|NCT01068730|147162583|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|99.67|||||TWO_SIDED|95.0|96.16|103.31|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||103.31|96.16|
73806694|NCT01068730|147162583|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7062.8||||||||||||||Geometric least squares means for Treatment A||||
73806695|NCT01068730|147162583|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7245.2||||||||||||||Geometric least squares means for Treatment B||||
73806696|NCT01068730|147162583|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11680.0||||||||||||||Geometric least squares means for Treatment C||||
73895652|NCT03745820|147324778|SUPERIORITY||LS Mean Difference|3.42|STANDARD_ERROR_OF_MEAN|1.844|=|0.0659|TWO_SIDED|95.0|-0.23|7.06|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||7.06|-0.23|=0.0659
73895653|NCT03745820|147324779|SUPERIORITY||LS Mean Difference|0.208|STANDARD_ERROR_OF_MEAN|0.09|=|0.6653|TWO_SIDED|95.0|-0.32|0.5|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||0.50|-0.32|=0.6653
73895654|NCT03745820|147324779|SUPERIORITY||LS Mean Difference|0.206|STANDARD_ERROR_OF_MEAN|0.1|=|0.614|TWO_SIDED|95.0|-0.3|0.51|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||0.51|-0.30|=0.6140
73895655|NCT03745820|147324780|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.033|=|0.2886|TWO_SIDED|95.0|-3.14|0.94|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.94|-3.14|=0.2886
73895656|NCT03745820|147324780|SUPERIORITY||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.032|=|0.6349|TWO_SIDED|95.0|-1.55|2.53|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||2.53|-1.55|=0.6349
73895657|NCT03745820|147324781|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|1.345|=|0.7372|TWO_SIDED|95.0|-2.21|3.11||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Verbal Learning: Change From Baseline at Week 12||3.11|-2.21|=0.7372
73895658|NCT03745820|147324781|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|1.346|=|0.6894|TWO_SIDED|95.0|-3.2|2.12||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Verbal Learning: Change From Baseline at Week 12||2.12|-3.20|=0.6894
73806697|NCT01068730|147162583|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)]|11641.0||||||95.0||||||||Geometric least squares means for Treatment D||||
73806698|NCT01068730|147162584|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|101.12|||||TWO_SIDED|95.0|96.36|106.11|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||106.11|96.36|
73806699|NCT01068730|147162584|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|98.65|||||TWO_SIDED|95.0|93.94|103.59|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||103.59|93.94|
73806700|NCT01068730|147162584|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1013.6||||||||||||||Geometric least squares means for Treatment A||||
73806701|NCT01068730|147162584|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1024.9||||||||||||||Geometric least squares means for Treatment B||||
73806702|NCT01068730|147162584|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1643.8||||||||||||||Geometric least squares means for Treatment C||||
73806703|NCT01068730|147162584|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1621.6||||||||||||||Geometric least squares means for Treatment D||||
73806704|NCT01068730|147162594|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|103.19|||||TWO_SIDED|95.0|99.75|106.75|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|||106.75|99.75|
73806705|NCT01068730|147162594|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|99.44|||||TWO_SIDED|95.0|96.08|102.92|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.|||102.92|96.08|
73806706|NCT01068730|147162594|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|6907.1||||||||||||||Geometric least squares means for Treatment A||||
73806707|NCT01068730|147162594|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7127.4||||||95.0||||||||Geometric least squares means for Treatment B||||
73806708|NCT01068730|147162594|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11391.0||||||||||||||Geometric least squares means for Treatment C||||
73806709|NCT01068730|147162594|SUPERIORITY_OR_OTHER||[Geometric Least Squares Mean (ng*hr/mL)|11327.0||||||||||||||Geometric least squares means for Treatment D||||
73806710|NCT01113385|147162595|SUPERIORITY_OR_OTHER|||||||0.009||||||p value reflects the difference in mean FSPF pre vs post galactose treatment.|t-test, 2 sided|||||||0.009
73806711|NCT00594100|147162598|SUPERIORITY_OR_OTHER||Binomial Proportion|0.054|STANDARD_ERROR_OF_MEAN|0.016||0.002|TWO_SIDED|95.0|0.027|0.095|||One-Sample Binomial|Significance test was based on a one-sample binomial test|95% Confidence Interval is exact binomial using Clopper-Pearson method. Standard Error is from Normal approximation.|The EMPiRE Study tested the null hypothesis that the true MAE rate was greater than or equal to an Objective Performance Criterion (OPC) of 11.83% versus the alternative hypothesis that the true MAE rate was less than the OPC. The sample size was calculated based on 80% power and a Type I error rate of 0.025. The OPC was calculated from results of published carotid artery stenting studies that utilized distal embolic protection systems.||0.095|0.027|0.002
73806712|NCT01270464|147162604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.0507||0.0018|TWO_SIDED|95.0|0.06|0.259||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.259|0.060|0.0018
73806713|NCT01270464|147162604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.0508||0.0237|TWO_SIDED|95.0|0.016|0.215||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.215|0.016|0.0237
73806714|NCT01270464|147162605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.0543||0.0174|TWO_SIDED|95.0|0.023|0.237||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.237|0.023|0.0174
73806715|NCT01270464|147162605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.0543||0.3731|TWO_SIDED|95.0|-0.058|0.155||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.155|-0.058|0.3731
73895659|NCT03745820|147324781|SUPERIORITY||LS Mean Difference|-2.14|STANDARD_ERROR_OF_MEAN|1.162|=|0.0674|TWO_SIDED|95.0|-4.44|0.16||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Speed of Processing: Change From Baseline at Week 12||0.16|-4.44|=0.0674
73895660|NCT03745820|147324781|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|1.161|=|0.7132|TWO_SIDED|95.0|-2.72|1.87||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Speed of Processing: Change From Baseline at Week 12||1.87|-2.72|=0.7132
73895661|NCT03745820|147324781|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|1.203|=|0.9428|TWO_SIDED|95.0|-2.46|2.29||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Attention/Vigilance: Change From Baseline at Week 12||2.29|-2.46|=0.9428
73895662|NCT03745820|147324781|SUPERIORITY||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|1.202|=|0.4425|TWO_SIDED|95.0|-1.45|3.3||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Attention/Vigilance: Change From Baseline at Week 12||3.30|-1.45|=0.4425
73895663|NCT03745820|147324781|SUPERIORITY||LS Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|1.597|=|0.3455|TWO_SIDED|95.0|-4.66|1.64||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Visual Learning: Change From Baseline at Week 12||1.64|-4.66|=0.3455
73895664|NCT03745820|147324781|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|1.595|=|0.9686|TWO_SIDED|95.0|-3.09|3.21||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Visual Learning: Change From Baseline at Week 12||3.21|-3.09|=0.9686
73895665|NCT03745820|147324781|SUPERIORITY||LS Mean Difference|1.18|STANDARD_ERROR_OF_MEAN|1.351|=|0.3832|TWO_SIDED|95.0|-1.49|3.85||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Social Cognition: Change From Baseline at Week 12||3.85|-1.49|=0.3832
73806716|NCT01270464|147162606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.1212||0.0552|TWO_SIDED|95.0|-0.005|0.472||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.472|-0.005|0.0552
73806717|NCT01270464|147162606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.1215||0.802|TWO_SIDED|95.0|-0.209|0.27||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.270|-0.209|0.8020
73806718|NCT01270464|147162608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.359|STANDARD_ERROR_OF_MEAN|0.111||0.0014|TWO_SIDED|95.0|-0.577|-0.14||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.140|-0.577|0.0014
73895666|NCT03745820|147324781|SUPERIORITY||LS Mean DIfference|1.07|STANDARD_ERROR_OF_MEAN|1.357|=|0.4297|TWO_SIDED|95.0|-1.61|3.75||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Social Cognition: Change From Baseline at Week 12||3.75|-1.61|=0.4297
73895667|NCT03745820|147324781|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|1.438|=|0.6245|TWO_SIDED|95.0|-3.55|2.14||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Reasoning and Problem Solving: Change From Baseline at Week 12||2.14|-3.55|=0.6245
73895668|NCT03745820|147324781|SUPERIORITY||LS Mean Difference|1.59|STANDARD_ERROR_OF_MEAN|1.436|=|0.2698|TWO_SIDED|95.0|-1.25|4.43||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Reasoning and Problem Solving: Change From Baseline at Week 12||4.43|-1.25|=0.2698
73895669|NCT03745820|147324782|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.61|=|0.4654|TWO_SIDED|95.0|-1.65|0.76||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Positive Symptoms Subscale: Change From Baseline at Week 12||0.76|-1.65|=0.4654
73895670|NCT03745820|147324782|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.608|=|0.5886|TWO_SIDED|95.0|-1.53|0.87||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Positive Symptoms Subscale: Change From Baseline at Week 12||0.87|-1.53|=0.5886
73895671|NCT03745820|147324782|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.655|=|0.9079|TWO_SIDED|95.0|-1.37|1.22||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Negative Symptoms Subscale: Change From Baseline at Week 12||1.22|-1.37|=0.9079
73895672|NCT03745820|147324782|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.65|=|0.4441|TWO_SIDED|95.0|-1.78|0.79||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Negative Symptoms Subscale: Change From Baseline at Week 12||0.79|-1.78|=0.4441
73895673|NCT03745820|147324782|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.017|=|0.5537|TWO_SIDED|95.0|-5.18|2.79||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Total Score: Change From Baseline at Week 12||2.79|-5.18|=0.5537
73895674|NCT03745820|147324782|SUPERIORITY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|2.018|=|0.332|TWO_SIDED|95.0|-5.95|2.02||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Total Score: Change From Baseline at Week 12||2.02|-5.95|=0.3320
73895675|NCT03745820|147324783|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.128|=|0.8517|TWO_SIDED|95.0|-0.23|0.28|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.28|-0.23|=0.8517
73895676|NCT03745820|147324783|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.128|=|0.9952|TWO_SIDED|95.0|-0.25|0.25|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.25|-0.25|=0.9952
73895677|NCT01410357|147324799|SUPERIORITY|||||||0.785||||||Bonferroni corrections were conducted to adjust for multiple comparisons.|Mixed Models Analysis|||||||.785
73895678|NCT01410357|147324800|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.016
73895679|NCT01410357|147324801|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||<0.001
73895680|NCT01410357|147324802|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.003
73806719|NCT01270464|147162608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.238|STANDARD_ERROR_OF_MEAN|0.1108||0.0329|TWO_SIDED|95.0|-0.456|-0.019||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.019|-0.456|0.0329
73806720|NCT01270464|147162609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.359|STANDARD_ERROR_OF_MEAN|0.1582||0.0241|TWO_SIDED|95.0|0.047|0.67||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.670|0.047|0.0241
73895681|NCT01410357|147324803|SUPERIORITY|||||||0.086|||||||Mixed Models Analysis|||||||.086
73895682|NCT01410357|147324804|SUPERIORITY|||||||0.872|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.872
73895683|NCT01410357|147324805|SUPERIORITY|||||||0.662|||||||Mixed Models Analysis|||||||.662
73895684|NCT01410357|147324806|SUPERIORITY|||||||0.633|||||||Mixed Models Analysis|||||||.633
73895685|NCT01410357|147324807|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.175
73895686|NCT01410357|147324808|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.680
73895687|NCT01410357|147324809|SUPERIORITY|||||||0.407|||||||Mixed Models Analysis|||||||.407
73895688|NCT01410357|147324810|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||||||.870
73895689|NCT01410357|147324811|SUPERIORITY|||||||0.707|||||||Mixed Models Analysis|||||||.707
73895690|NCT01410357|147324812|SUPERIORITY|||||||0.838|||||||Mixed Models Analysis|||||||.838
73895691|NCT01410357|147324813|SUPERIORITY|||||||0.853|||||||Mixed Models Analysis|||||||.853
73895692|NCT01410357|147324814|SUPERIORITY|||||||0.853|||||||Mixed Models Analysis|||||||.853
73895693|NCT01410357|147324815|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||||||.510
73895694|NCT01410357|147324816|SUPERIORITY|||||||0.573|||||||Mixed Models Analysis|||||||.573
73895695|NCT01410357|147324817|SUPERIORITY|||||||0.758|||||||Mixed Models Analysis|||||||.758
73895696|NCT01410357|147324818|SUPERIORITY|||||||0.156|||||||Mixed Models Analysis|||||||.156
73895697|NCT01410357|147324819|SUPERIORITY|||||||0.156|||||||Mixed Models Analysis|||||||.156
73895698|NCT01410357|147324820|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
73895699|NCT01410357|147324821|SUPERIORITY|||||||0.878|||||||Mixed Models Analysis|||||||.878
73895700|NCT01410357|147324822|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||.014
73895701|NCT01410357|147324823|SUPERIORITY|||||||0.227|||||||Mixed Models Analysis|||||||.227
73806721|NCT01270464|147162609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.1591||0.0822|TWO_SIDED|95.0|-0.036|0.591||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.591|-0.036|0.0822
73895702|NCT00635219|147324863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.13||0.1321|TWO_SIDED|95.0|-3.92|0.51||Since p-value \>0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||0.51|-3.92|0.1321
73895703|NCT00635219|147324863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.13||0.1847|TWO_SIDED|95.0|-3.73|0.72||Since p-value \>0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||0.72|-3.73|0.1847
73895704|NCT00635219|147324863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.12||0.2187|TWO_SIDED|95.0|-3.59|0.82||This dose was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||0.82|-3.59|0.2187
73895705|NCT00635219|147324863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|1.14||0.0741|TWO_SIDED|95.0|-4.27|0.2||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||0.20|-4.27|0.0741
73895706|NCT00635219|147324864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|1.13||0.112|TWO_SIDED|95.0|-4.01|0.42||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.42|-4.01|0.1120
73895707|NCT00635219|147324864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|STANDARD_ERROR_OF_MEAN|1.13||0.1487|TWO_SIDED|95.0|-3.85|0.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.59|-3.85|0.1487
73895708|NCT00635219|147324864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|1.12||0.3246|TWO_SIDED|95.0|-3.31|1.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.10|-3.31|0.3246
73895709|NCT00635219|147324864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47|STANDARD_ERROR_OF_MEAN|1.13||0.0298|TWO_SIDED|95.0|-4.7|-0.24||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||-0.24|-4.70|0.0298
73806722|NCT01270464|147162610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.0193||0.016|TWO_SIDED|95.0|0.009|0.085||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.085|0.009|0.0160
73806723|NCT01270464|147162610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.0193||0.0094|TWO_SIDED|95.0|0.012|0.089||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.089|0.012|0.0094
73895710|NCT00635219|147324865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.137|TWO_SIDED|95.0|0.9|2.23||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.23|0.90|0.1370
73895711|NCT00635219|147324865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.0664|TWO_SIDED|95.0|0.97|2.43||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.43|0.97|0.0664
73895712|NCT00635219|147324865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.2023|TWO_SIDED|95.0|0.85|2.12||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.12|0.85|0.2023
73895713|NCT00635219|147324865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0765|TWO_SIDED|95.0|0.96|2.4||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.40|0.96|0.0765
73895714|NCT00635219|147324866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1436|TWO_SIDED|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.07|-0.47|0.1436
73895715|NCT00635219|147324866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2114|TWO_SIDED|95.0|-0.44|0.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.10|-0.44|0.2114
73895716|NCT00635219|147324866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1389|TWO_SIDED|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.07|-0.47|0.1389
73895717|NCT00635219|147324866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.14||0.1271|TWO_SIDED|95.0|-0.48|0.06||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.06|-0.48|0.1271
73895718|NCT00635219|147324867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.49||0.4421|TWO_SIDED|95.0|-4.08|1.79||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.79|-4.08|0.4421
73895719|NCT00635219|147324867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.49||0.4399|TWO_SIDED|95.0|-4.07|1.77||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.77|-4.07|0.4399
73895720|NCT00635219|147324867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|1.54||0.8093|TWO_SIDED|95.0|-2.65|3.4||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||3.40|-2.65|0.8093
73806724|NCT01270464|147162611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.624|STANDARD_ERROR_OF_MEAN|0.2551||0.0151|TWO_SIDED|95.0|-1.126|-0.121||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.121|-1.126|0.0151
73806725|NCT01270464|147162611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.648|STANDARD_ERROR_OF_MEAN|0.2559||0.0119|TWO_SIDED|95.0|-1.152|-0.144||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.144|-1.152|0.0119
73806726|NCT01270464|147162612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.494|STANDARD_ERROR_OF_MEAN|0.0242||0|TWO_SIDED|95.0|-0.542|-0.447||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Regression, Logistic|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.447|-0.542|0.0000
73806727|NCT01270464|147162612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.323|STANDARD_ERROR_OF_MEAN|0.0243||0|TWO_SIDED|95.0|-0.37|-0.275||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.275|-0.370|0.0000
73806728|NCT01369030|147162665|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5|STANDARD_DEVIATION|6.3||0|||||||Wilcoxon signed-rank test|||||||0.000
73806729|NCT01560234|147162753|SUPERIORITY_OR_OTHER||Slope|0.81|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|0.63|1.0|||Regression, Linear||AUC (nmol\*h/L) 5 to 30 μg|||1.00|0.63|
73806730|NCT01560234|147162754|SUPERIORITY_OR_OTHER||Slope|0.84|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|0.65|1.04|||Regression, Linear||AUC(0-t) (nmol\*h/L) 5 to 30 μg|||1.04|0.65|
73806731|NCT01560234|147162755|SUPERIORITY_OR_OTHER||Slope|0.95|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|90.0|0.87|1.04|||Regression, Linear||Cmax (nmol/L) 0.5 to 30 μg|||1.04|0.87|
73806732|NCT01560234|147162756|SUPERIORITY_OR_OTHER||Percentage of Placebo|99.75|||||TWO_SIDED|95.0|65.76|151.32|||ANCOVA||Cohort 1/0.15 ug vs Placebo|24 hour Plasma||151.32|65.76|
73806733|NCT01560234|147162756|SUPERIORITY_OR_OTHER||Percentage of Placebo|92.99|||||TWO_SIDED|95.0|61.21|141.27|||ANCOVA||Cohort 2/1.5ug vs Placebo|24 hour Plasma||141.27|61.21|
73806734|NCT01560234|147162756|SUPERIORITY_OR_OTHER||Percentage of Placebo|145.83|||||TWO_SIDED|95.0|96.11|221.28|||ANCOVA||Cohort 4/5 ug vs Placebo|24 hour Plasma||221.28|96.11|
73806735|NCT01560234|147162756|SUPERIORITY_OR_OTHER||Percentage of Placebo|106.23|||||TWO_SIDED|95.0|66.42|169.93|||ANCOVA||Cohort 3/1.5 ug vs Placebo|24 hour Plasma||169.93|66.42|
73806736|NCT01560234|147162756|SUPERIORITY_OR_OTHER||Percentage of Placebo|223.76||||||95.0|144.98|345.35|||ANCOVA||Cohort 5/15 μg vs Placebo|24 hour plasma||345.35|144.98|
73806737|NCT01560234|147162756|SUPERIORITY_OR_OTHER||Percentage of Placebo|228.23|||||TWO_SIDED|95.0|150.36|346.41|||ANCOVA||Cohort 7/15 μg vs Placebo|24 hour plasma||346.41|150.36|
73806738|NCT01560234|147162756|SUPERIORITY_OR_OTHER||Percentage of Placebo|684.03|||||TWO_SIDED|95.0|495.31|944.65|||ANCOVA||Cohort 6 and 8/30 μg vs Placebo|24 hour plasma||944.65|495.31|
73806739|NCT01560234|147162757|SUPERIORITY_OR_OTHER||Percentage of Placebo|95.81|||||TWO_SIDED|95.0|72.7|126.28|||ANCOVA||Cohort 1/0.15 ug vs Placebo|48 hour plasma||126.28|72.70|
73806740|NCT01560234|147162757|SUPERIORITY_OR_OTHER||Percentage of Placebo|91.72|||||TWO_SIDED|95.0|69.53|121.0|||ANCOVA||Cohort 2/0.5 ug vs Placebo|48 hour plasma||121.00|69.53|
73806741|NCT01560234|147162757|SUPERIORITY_OR_OTHER||Percentage of Placebo|112.34|||||TWO_SIDED|95.0|82.3|153.35|||ANCOVA||Cohort 3/1.5 ug vs Placebo|48 hour Plasma||153.35|82.30|
73806742|NCT01560234|147162757|SUPERIORITY_OR_OTHER||Percentage of Placebo|120.0|||||TWO_SIDED|95.0|91.04|158.18|||ANCOVA||Cohort 4/5 ug vs Placebo|48 hour plasma||158.18|91.04|
73806743|NCT01560234|147162757|SUPERIORITY_OR_OTHER||Percentage of Placebo|102.67|||||TWO_SIDED|95.0|77.02|136.87|||ANCOVA||Cohort 5/15 ug vs Placebo|48 hour placebo||136.87|77.02|
73806744|NCT01560234|147162757|SUPERIORITY_OR_OTHER||Percentage of Placebo|146.86|||||TWO_SIDED|95.0|111.39|193.62|||ANCOVA||Cohort 7/15 ug vs Placebo|48 hour plasma||193.62|111.39|
73806745|NCT01560234|147162757|SUPERIORITY_OR_OTHER||Percentage of Placebo|240.04|||||TWO_SIDED|95.0|193.82|297.28|||ANCOVA||Cohort 6 and 8/30 ug|48 hour plasma||297.28|193.82|
73806746|NCT01560234|147162759|SUPERIORITY_OR_OTHER||Comparison of Placebo|114.87|||||TWO_SIDED|95.0|34.83|378.78|||ANCOVA||Cohort 1/0.15 ug vs Placebo|24 hour Sputum||378.78|34.83|
73806747|NCT01560234|147162759|SUPERIORITY_OR_OTHER||Comparison of Placebo|81.89|||||TWO_SIDED|95.0|24.96|268.7|||ANCOVA||Cohort 2/0.5 ug vs Placebo|24 hour Sputum||268.70|24.96|
73806748|NCT01560234|147162759|SUPERIORITY_OR_OTHER||Comparison of Placebo|81.55|||||TWO_SIDED|95.0|20.63|322.42|||ANCOVA||Cohort 3/1.5 ug vs Placebo|24 hour Sputum||322.42|20.63|
73806749|NCT01560234|147162759|SUPERIORITY_OR_OTHER||Comparison of Placebo|304.37|||||TWO_SIDED|95.0|76.61|1209.33|||ANCOVA||Cohort 4/5 ug vs Placebo|24 hour Sputum||1209.33|76.61|
73806750|NCT01560234|147162759|SUPERIORITY_OR_OTHER||Comparison of Placebo|193.8|||||TWO_SIDED|95.0|59.01|636.49|||ANCOVA||Cohort 5/15 μg vs Placebo|24 hour Sputum||636.49|59.01|
73806751|NCT01560234|147162759|SUPERIORITY_OR_OTHER||Comparison of Placebo|467.96|||||TWO_SIDED|95.0|142.77|1533.92|||ANCOVA||Cohort 7/15 μg vs Placebo|24 hour Sputum||1533.92|142.77|
73806752|NCT01560234|147162759|SUPERIORITY_OR_OTHER||Comparison of Placebo|1087.35|||||TWO_SIDED|95.0|317.19|3727.57|||ANCOVA||Cohort 6 and 8/30 μg vs Placebo|24 hour Sputum||3727.57|317.19|
73806753|NCT00083759|147162768|SUPERIORITY_OR_OTHER|||||||0.089||95.0|||||Cochran-Mantel-Haenszel|||||||0.089
73806754|NCT00083759|147162769|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Cochran-Mantel-Haenszel|||||||0.171
73806755|NCT00083759|147162770|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||Cochran-Mantel-Haenszel|||||||0.526
73806756|NCT03567005|147162771|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.05. With a sample size of 36 (18 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in distance visual acuity with assumed standard deviation of 0.098 for paired difference (one-sided alpha=0.05).|Least Squares Mean (LSM) Difference|0.0|STANDARD_ERROR_OF_MEAN|0.008|||ONE_SIDED|95.0||0.02||||||||0.02||
73806757|NCT03567005|147162772|NON_INFERIORITY|The pre-specified non-inferiority margin is 1.0. With a sample size of 48 (24 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in subjective overall vision with assumed standard deviation of 2.29 for paired differences (one-sided alpha=0.05).|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15|||ONE_SIDED|95.0|-0.3||||||||||-0.3|
73806758|NCT00379080|147162789|OTHER|||||||0.04|||||||Regression, Cox|||VEGFR2||||0.04
73806759|NCT00379080|147162789|OTHER|||||||0.04|||||||Regression, Cox|||PIGF||||0.04
73806760|NCT00379080|147162789|OTHER|||||||0.02|||||||Regression, Cox|||CAIX||||0.02
73806761|NCT00379080|147162789|OTHER|||||||0.05|||||||Regression, Cox|||sFLT\_1||||0.05
73806762|NCT00379080|147162789|OTHER|||||||0.01|||||||Regression, Cox|||sFLT\_1||||0.01
73806763|NCT00379080|147162789|OTHER|||||||0.05|||||||Regression, Cox|||VEGFR2||||0.05
73806764|NCT02901067|147162793|SUPERIORITY|This is a secondary outcome thus no power analysis was done.|||||>|0.05|||||||Fisher Exact|||We hypothesized that the experimental group would present less fibrinolysis shutdown than the control group in all times measured.||||>0.05
73806765|NCT02901067|147162798|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
73806766|NCT02901067|147162801|SUPERIORITY|||||||0.1|||||||Fisher Exact|||We hypothesized that the experimental group would have less pulmonary embolism events than the control group.||||0.10
73806767|NCT02901067|147162802|SUPERIORITY|||||||0.046|||||||Fisher Exact|||We hypothesized that the experimental group would have a lower incidence of venous thromboembolism (VTE) than the control group.||||0.046
73806768|NCT00497289|147162820|SUPERIORITY|||||||0.3654|||||||Wilcoxon (Mann-Whitney)|||||||0.3654
73806769|NCT00497289|147162821|SUPERIORITY|||||||0.0264|||||||Wilcoxon (Mann-Whitney)|||||||0.0264
73806770|NCT02920008|147162825|SUPERIORITY||||||=|0.3287|||||||Stratified log-rank|||||||= 0.3287
73806771|NCT03169881|147162848|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.88|TWO_SIDED|95.0|-3.09|2.64||The mean difference in Bayley-III cognitive scores between treatment groups was adjusted for center, gestational age group, and familial clustering.|Mixed Models Analysis||Adjusted mean difference in cognitive score for the Darbepoetin minus Placebo treatment groups.|Null hypothesis: Weekly administration of Darbepoetin during the neonatal period will not impact neurocognitive outcomes at 22-26 months compared to Placebo in premature infants 23 to 28 weeks gestation.||2.64|-3.09|0.88
73806772|NCT01028014|147162862|SUPERIORITY_OR_OTHER||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all \>0.05.P-values were not adjusted for multiple testing; p\<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.||||>0.05
73806773|NCT01028014|147162863|SUPERIORITY_OR_OTHER||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all \>0.05.P-values were not adjusted for multiple testing; p\<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.||||>0.05
73806774|NCT00930774|147162879|SUPERIORITY_OR_OTHER|||||||0.527|||||||ANOVA|df = 3,83; F=0.748||||||0.527
73806775|NCT00930774|147162880|SUPERIORITY_OR_OTHER|||||||0.835|||||||ANOVA|df = 3,83; F=0.286||||||0.835
73806776|NCT00930774|147162881|SUPERIORITY_OR_OTHER|||||||0.983|||||||ANOVA|df = 3,83; F=0.054||||||0.983
73806777|NCT00930774|147162882|SUPERIORITY_OR_OTHER|||||||0.554||||||df = 3,83; F=0.701|ANOVA|||||||0.554
73806778|NCT00930774|147162883|SUPERIORITY_OR_OTHER|||||||0.757||||||df = 3,83; F=0.395|ANOVA|||||||0.757
73806779|NCT00930774|147162884|SUPERIORITY_OR_OTHER|||||||0.302|||||||ANOVA|df = 3,83; F=1.236||||||0.302
73806780|NCT00930774|147162885|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|df = 3,83. F=6.343||||||0.001
73806781|NCT00930774|147162885|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73806782|NCT00930774|147162886|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANOVA|df = 3,83; F=3.797||||||0.013
73806783|NCT00930774|147162886|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
73806784|NCT03200704|147162887|NON_INFERIORITY|90% power, 2.5% one-sided significance level,5% non-inferiority margin|||||<|0.0001|||||||Regression, Logistic|||"Hypothesis:~H0: QT ≤ QC - 0.05 H1: QT \> QC - 0.05"||||<0.0001
73806785|NCT00839527|147162894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.68|||ANCOVA|||||-0.68|-1.07|<0.0001
73806786|NCT00839527|147162894|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a one-sided t-test testing at the 0.025 level of significance whether or not the difference of least square means (albiglutide - pioglitazone) is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Mean Difference (Net)|0.25||||0.2685|TWO_SIDED|95.0|0.1|0.4|||t-test, 1 sided|||||0.40|0.10|0.2685
73806787|NCT04431908|147162903|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Specificity|89.35|||||TWO_SIDED|||||||||||||
73895721|NCT00635219|147324867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.53||0.0897|TWO_SIDED|95.0|-5.61|0.41||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.41|-5.61|0.0897
73806788|NCT04431908|147162903|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Sensitivity|42.55|||||TWO_SIDED|||||||||||||
73806789|NCT04431908|147162903|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Accuracy|87.24|||||TWO_SIDED|||||||||||||
73806790|NCT04431908|147162905|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Specificity|88.73|||||TWO_SIDED|||||||||||||
73806791|NCT04431908|147162905|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Sensitivity|33.33|||||TWO_SIDED|||||||||||||
73806792|NCT04431908|147162905|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Accuracy|88.13|||||TWO_SIDED|||||||||||||
73806793|NCT01704651|147162906|SUPERIORITY_OR_OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
73806794|NCT01704651|147162907|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
73806795|NCT00778869|147162914|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student t-test|||||||<0.05
73806796|NCT00520533|147162932|SUPERIORITY|||||||0.194|||||||t-test, 2 sided|||Comparison of Biological T1/2 at Week 1 and Week 5.||||0.194
73806797|NCT00520533|147162933|SUPERIORITY|||||||0.172|||||||t-test, 2 sided|||Comparison of Effective T1/2 at Week 1 and Week 5.||||0.172
73806798|NCT02703467|147162959|SUPERIORITY||||||>|0.05||||||calculated|t-test, 2 sided|||||||>0.05
73806799|NCT03386994|147162969|OTHER|||||||0.0002|||||||ANOVA|Total annual IPF-related costs||||||0.0002
73806800|NCT03386994|147162969|OTHER|||||||0.0007|||||||ANOVA|Annual direct health IPF-related costs||||||0.0007
73806801|NCT03386994|147162969|OTHER||||||<|0.0001|||||||ANOVA|Annual direct non-health IPF-related costs||||||<0.0001
73806802|NCT03386994|147162969|OTHER|||||||0.6839|||||||ANOVA|Annual indirect IPF-related costs||||||0.6839
73806803|NCT03386994|147162970|OTHER|||||||0.002|||||||Kruskal-Wallis|Timepoint: T0||||||0.0020
73806804|NCT03386994|147162970|OTHER|||||||0.1385|||||||Kruskal-Wallis|Timepoint: T6||||||0.1385
73895722|NCT00635219|147324868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.98||0.6748|TWO_SIDED|95.0|-2.35|1.52||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.52|-2.35|0.6748
73895723|NCT00635219|147324868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.99||0.0871|TWO_SIDED|95.0|-3.64|0.25||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.25|-3.64|0.0871
73895724|NCT00635219|147324868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|0.99||0.3186|TWO_SIDED|95.0|-2.94|0.96||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.96|-2.94|0.3186
73895725|NCT00635219|147324868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.01||0.0768|TWO_SIDED|95.0|-3.79|0.19||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.19|-3.79|0.0768
73806805|NCT03386994|147162970|OTHER|||||||0.0233|||||||Kruskal-Wallis|Timepoint: T12||||||0.0233
73895726|NCT00635219|147324869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.6258|TWO_SIDED|95.0|0.7|1.81||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.81|0.70|0.6258
73806806|NCT03386994|147162971|OTHER|||||||0.156||||||Timepoint: T0|Kruskal-Wallis|||||||0.1560
73806807|NCT03386994|147162971|OTHER|||||||0.3144||||||Timepoint: T6|Kruskal-Wallis|||||||0.3144
73806808|NCT03386994|147162971|OTHER|||||||0.2019||||||Timepoint: T12|Kruskal-Wallis|||||||0.2019
73806809|NCT03386994|147162972|OTHER|||||||0.0075||||||Timepoint: T0|Kruskal-Wallis|||||||0.0075
73806810|NCT03386994|147162972|OTHER|||||||0.0361||||||Timepoint: T6|Kruskal-Wallis|||||||0.0361
73806811|NCT03386994|147162972|OTHER|||||||0.4794||||||Timepoint: T12|Kruskal-Wallis|||||||0.4794
73806812|NCT03386994|147162973|OTHER|||||||0.0333|||||||Fisher Exact|||||||0.0333
73806813|NCT03386994|147162975|OTHER|||||||0.4711|||||||ANOVA|Total annual IPF-related costs||||||0.4711
73806814|NCT03386994|147162975|OTHER|||||||0.4095|||||||ANOVA|Annual direct health IPF-related costs||||||0.4095
73806815|NCT03386994|147162975|OTHER|||||||0.0435|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.0435
73806816|NCT03386994|147162975|OTHER|||||||0.5479|||||||ANOVA|Annual indirect IPF-related costs||||||0.5479
73806817|NCT03386994|147162977|OTHER|||||||0.7486|||||||ANOVA|Total annual IPF-related costs||||||0.7486
73806818|NCT03386994|147162977|OTHER|||||||0.7652|||||||ANOVA|Annual direct health IPF-related costs||||||0.7652
73806819|NCT03386994|147162977|OTHER|||||||0.0037|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.0037
73806820|NCT03386994|147162977|OTHER|||||||0.6119|||||||ANOVA|Annual indirect IPF-related costs||||||0.6119
73806821|NCT03386994|147162978|OTHER|||||||0.1581|||||||ANOVA|Total annual IPF-related costs||||||0.1581
73806822|NCT03386994|147162978|OTHER|||||||0.1581|||||||ANOVA|Annual direct health IPF-related costs||||||0.1581
73806823|NCT03386994|147162978|OTHER|||||||0.7165|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.7165
73806824|NCT03386994|147162978|OTHER|||||||1|||||||ANOVA|Annual indirect IPF-related costs||||||1.0000
73806825|NCT03386994|147162979|OTHER|||||||0.0733|||||||Kruskal-Wallis|||||||0.0733
73806826|NCT03386994|147162981|OTHER|||||||0.0207|||||||Kruskal-Wallis|||||||0.0207
73806827|NCT03386994|147162982|OTHER|||||||0.0942|||||||Kruskal-Wallis|||||||0.0942
73806828|NCT03386994|147162983|OTHER|||||||0.0747|||||||Kruskal-Wallis|||||||0.0747
73895727|NCT00635219|147324869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7178|TWO_SIDED|95.0|0.68|1.76||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.76|0.68|0.7178
73895728|NCT00635219|147324869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8651|TWO_SIDED|95.0|0.59|1.55||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.55|0.59|0.8651
73806829|NCT03386994|147162985|OTHER|||||||0.1282|||||||Kruskal-Wallis|||||||0.1282
73806830|NCT03386994|147162986|OTHER|||||||0.7471|||||||Kruskal-Wallis|||||||0.7471
73806831|NCT00653133|147163020|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Null hypothesis: There is no difference in reported complications associated with the placement of continuous peripheral nerve block catheters between ultrasound imaging guided placement and nerve stimulator guided placement.||||<0.05
73806832|NCT02282631|147163034|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|"U=390.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."||||||0.02
73806833|NCT02282631|147163035|SUPERIORITY_OR_OTHER|||||||0.02||||||"U=665.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.02
73806834|NCT02282631|147163036|SUPERIORITY_OR_OTHER|||||||0.02||||||"U=596.5 Z=-2.4 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.02
73806835|NCT02282631|147163037|SUPERIORITY_OR_OTHER|||||||0.01||||||"U=955.0 Z=-2.5 p=0.01~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.01
73806836|NCT05088603|147163044|SUPERIORITY|||||||0.106|||||||Fisher Exact|||||||0.106
73806837|NCT05088603|147163045|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
73806838|NCT05088603|147163046|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
73806839|NCT05088603|147163048|SUPERIORITY|||||||0.529|||||||Fisher Exact|||||||0.529
73895729|NCT00635219|147324869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8563|TWO_SIDED|95.0|0.65|1.69||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.69|0.65|0.8563
73895730|NCT00635219|147324870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.86||0.1925|TWO_SIDED|95.0|-2.82|0.57||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.57|-2.82|0.1925
73895731|NCT00635219|147324870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.87||0.2434|TWO_SIDED|95.0|-2.72|0.69||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.69|-2.72|0.2434
73895732|NCT00635219|147324870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.86||0.7246|TWO_SIDED|95.0|-2.0|1.39||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.39|-2.00|0.7246
73806840|NCT05088603|147163049|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
73806841|NCT05088603|147163050|SUPERIORITY|||||||0.502|||||||Fisher Exact|||||||0.502
73895733|NCT00635219|147324870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.87||0.0981|TWO_SIDED|95.0|-3.16|0.27||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.27|-3.16|0.0981
73895734|NCT00635219|147324871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2285|TWO_SIDED|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.11|-0.46|0.2285
73895735|NCT00635219|147324871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1794|TWO_SIDED|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.09|-0.48|0.1794
73806842|NCT05088603|147163051|SUPERIORITY|||||||0.431|||||||Fisher Exact|||||||0.431
73806843|NCT05088603|147163052|SUPERIORITY|||||||0.434|||||||Fisher Exact|||||||0.434
73806844|NCT05088603|147163053|SUPERIORITY|||||||0.159|||||||Fisher Exact|||||||0.159
73806845|NCT05088603|147163054|SUPERIORITY|||||||0.051|||||||Fisher Exact|||||||0.051
73806846|NCT02162719|147163079|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.6||||0.0372|TWO_SIDED|90.0|0.4|0.91||Stratification variables were adjuvant/neoadjuvant treatment including treatment with or without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||0.91|0.40|0.0372
73806847|NCT02162719|147163080|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.59||||0.1753|TWO_SIDED|90.0|0.3|1.16||Stratification variables were adjuvant/neoadjuvant treatment including treatment with or without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.16|0.30|0.1753
73806848|NCT02162719|147163081|SUPERIORITY||Hazard Ratio (Unstratified Analysis)|0.76||||0.3636|TWO_SIDED|90.0|0.46|1.27|||Log Rank|||||1.27|0.46|0.3636
73806849|NCT02162719|147163082|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.8||||0.3607|TWO_SIDED|95.0|0.5|1.28||Stratification variables were adjuvant/neoadjuvant treatment including treatment with/without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.28|0.50|0.3607
73806850|NCT02162719|147163083|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.73||||0.4422|TWO_SIDED|95.0|0.32|1.65||Stratification variables were adjuvant/neoadjuvant treatment including treatment with/without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.65|0.32|0.4422
73806851|NCT02162719|147163084|SUPERIORITY||Hazard Ratio (Unstratified Analysis)|1.13||||0.7599|TWO_SIDED|95.0|0.52|2.47|||Log Rank|||||2.47|0.52|0.7599
73806852|NCT04932655|147163162|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|103.22|||||TWO_SIDED|90.0|96.88|109.98||||||||109.98|96.88|
73806853|NCT04932655|147163162|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|109.64|||||TWO_SIDED|90.0|102.9|116.82||||||||116.82|102.9|
73806854|NCT04932655|147163162|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|102.9|||||TWO_SIDED|90.0|96.57|109.64||||||||109.64|96.57|
73806855|NCT04932655|147163163|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.47|||||TWO_SIDED|90.0|96.33|100.65||||||||100.65|96.33|
73806856|NCT04932655|147163163|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.88|||||TWO_SIDED|90.0|96.74|101.07||||||||101.07|96.74|
73806857|NCT04932655|147163163|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|100.32|||||TWO_SIDED|90.0|98.15|102.54||||||||102.54|98.15|
73806858|NCT04932655|147163164|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.5|||||TWO_SIDED|90.0|96.33|100.71||||||||100.71|96.33|
73806859|NCT04932655|147163164|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|99.03|||||TWO_SIDED|90.0|96.85|101.26||||||||101.26|96.85|
73806860|NCT04932655|147163164|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|100.25|||||TWO_SIDED|90.0|98.05|102.5||||||||102.50|98.05|
73806861|NCT04075682|147163188|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus their not being equal.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.51||0.6|TWO_SIDED|95.0|-0.73|1.25||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.25|-0.73|0.60
73806862|NCT04075682|147163188|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus their not being equal.|Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|0.73||0.29|TWO_SIDED|95.0|-2.22|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.66|-2.22|0.29
73806863|NCT04075682|147163188|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.72||0.73|TWO_SIDED|95.0|-1.67|1.16||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.16|-1.67|0.73
73806864|NCT04075682|147163188|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.04||0.77|TWO_SIDED|95.0|-2.34|1.74||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.74|-2.34|0.77
73806865|NCT04075682|147163188|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|1.1||0.51|TWO_SIDED|95.0|-1.43|2.88||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||2.88|-1.43|0.51
73895736|NCT00635219|147324871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1741|TWO_SIDED|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.09|-0.48|0.1741
73895737|NCT00635219|147324871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2247|TWO_SIDED|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.11|-0.46|0.2247
73895738|NCT00635219|147324872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.86||0.7789|TWO_SIDED|95.0|-1.93|1.45||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.45|-1.93|0.7789
73806866|NCT04075682|147163188|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.02||0.05|TWO_SIDED|95.0|0.02|4.01||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||4.01|0.02|0.05
73806867|NCT04075682|147163188|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|1.49||0.54|TWO_SIDED|95.0|-3.84|2.02||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.02|-3.84|0.54
73806868|NCT04075682|147163188|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.61||0.21|TWO_SIDED|95.0|-1.13|5.17||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||5.17|-1.13|0.21
73806869|NCT04075682|147163188|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|1.48||0.47|TWO_SIDED|95.0|-3.97|1.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.83|-3.97|0.47
73806870|NCT04075682|147163189|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.49||0.57|TWO_SIDED|95.0|-0.68|1.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.24|-0.68|0.57
73806871|NCT04075682|147163189|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.25|STANDARD_ERROR_OF_MEAN|0.71||0.08|TWO_SIDED|95.0|-2.63|0.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.14|-2.63|0.08
73806872|NCT04075682|147163189|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.39|TWO_SIDED|95.0|-1.97|0.77||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment, comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||0.77|-1.97|0.39
73895739|NCT00635219|147324872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.87||0.8121|TWO_SIDED|95.0|-1.91|1.5||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.50|-1.91|0.8121
73895740|NCT00635219|147324872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.87||0.8918|TWO_SIDED|95.0|-1.82|1.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.59|-1.82|0.8918
73806873|NCT04075682|147163189|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|1.0||0.61|TWO_SIDED|95.0|-1.45|2.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.47|-1.45|0.61
73806874|NCT04075682|147163189|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|1.07||0.9|TWO_SIDED|95.0|-2.23|1.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.97|-2.23|0.90
73806875|NCT04075682|147163189|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|0.98||0.04|TWO_SIDED|95.0|0.13|3.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.97|0.13|0.04
73806876|NCT04075682|147163189|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|1.43||0.64|TWO_SIDED|95.0|-2.14|3.48||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.48|-2.14|0.64
73806877|NCT04075682|147163189|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|1.56||0.92|TWO_SIDED|95.0|-2.91|3.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.20|-2.91|0.92
73806878|NCT04075682|147163189|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-2.25|STANDARD_ERROR_OF_MEAN|1.41||0.11|TWO_SIDED|95.0|-5.02|0.52||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||0.52|-5.02|0.11
73806879|NCT04075682|147163190|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.59||0.57|TWO_SIDED|95.0|-1.48|0.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.82|-1.48|0.57
73895741|NCT00635219|147324872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.87||0.972|TWO_SIDED|95.0|-1.69|1.75||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.75|-1.69|0.9720
73806880|NCT04075682|147163190|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|1.14||0.39|TWO_SIDED|95.0|-3.22|1.27||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial warnings (averaged over insert) vs no pictorial warnings (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.27|-3.22|0.39
73806881|NCT04075682|147163190|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|1.63||0.92|TWO_SIDED|95.0|-3.35|3.04||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.04|-3.35|0.92
73806882|NCT04075682|147163191|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.48||0.4|TWO_SIDED|95.0|-1.33|0.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.53|-1.33|0.40
73806883|NCT04075682|147163191|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.94||0.99|TWO_SIDED|95.0|-1.83|1.86||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial health warning labels (HWLs) (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.86|-1.83|0.99
73806884|NCT04075682|147163191|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.85|STANDARD_ERROR_OF_MEAN|1.34||0.17|TWO_SIDED|95.0|-0.78|4.48||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||4.48|-0.78|0.17
73806885|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.58||0.45|TWO_SIDED|95.0|-0.69|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.57|-0.69|0.45
73895742|NCT00505076|147324881|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANCOVA|||An analysis of covariance (ANCOVA), adjusting for baseline scores, was used to compare treatment groups on cognitive and functional measures. The predefined primary cognition outcome measure was the MCCB (MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia Research) Consensus Cognitive Battery) composite T-score, tested at overall two-sided alpha=0.05.||||0.21
73895743|NCT00505076|147324882|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2\[za+zβ\]2s2 (1-R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.||||0.47
73806886|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.58||0.41|TWO_SIDED|95.0|-1.61|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.66|-1.61|0.41
73806887|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.44|STANDARD_ERROR_OF_MEAN|0.84||0.08|TWO_SIDED|95.0|-3.08|0.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.20|-3.08|0.08
73806888|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.82||0.52|TWO_SIDED|95.0|-2.14|1.09||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.09|-2.14|0.52
73806889|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|1.11||0.75|TWO_SIDED|95.0|-1.82|2.51||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||2.51|-1.82|0.75
73806890|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|1.57||0.64|TWO_SIDED|95.0|-3.82|2.33||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.33|-3.82|0.64
73806891|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.18||0.91|TWO_SIDED|95.0|-2.17|2.45||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.45|-2.17|0.91
73806892|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|1.25||0.5|TWO_SIDED|95.0|-3.29|1.6||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.60|-3.29|0.50
73895744|NCT00505076|147324883|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2\[za+zβ\]2s2 (1-R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.||||0.84
73806893|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|3.14|STANDARD_ERROR_OF_MEAN|1.16||0.007|TWO_SIDED|95.0|0.86|5.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||5.41|0.86|0.007
73806894|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.09|STANDARD_ERROR_OF_MEAN|1.69||0.52|TWO_SIDED|95.0|-2.22|4.4||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||4.40|-2.22|0.52
73806895|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.82||0.86|TWO_SIDED|95.0|-3.89|3.23||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.23|-3.89|0.86
73806896|NCT04075682|147163192|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|1.68||0.61|TWO_SIDED|95.0|-4.15|2.43||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.43|-4.15|0.61
73806897|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.26|STANDARD_ERROR_OF_MEAN|0.28||0.29|TWO_SIDED|95.0|0.82|1.96||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.96|0.82|0.29
73806898|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.27||0.43|TWO_SIDED|95.0|0.77|1.85||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.85|0.77|0.43
73895745|NCT02250703|147324884|SUPERIORITY_OR_OTHER|||||||0.025||||||Difference in proportions in satisfactory sedation on separation from parents and on induction between M and D groups (Primary Outcome variables)|Chi-squared|||A sample size of at least 33 patients in each group would detect at least 30% difference in proportion of children who achieve satisfactory sedation between the M and D groups at 0.05 level of significance and 80% power||||0.025
73895746|NCT02250703|147324885|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73895747|NCT02250703|147324886|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73895748|NCT02250703|147324887|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73895749|NCT00322621|147324936|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.5 point on the BPI 24-hour average pain scale.|Mean Difference (Net)|0.35|||<|0.001||97.5|0.35|0.79||Significance level 0.025|t-test, 1 sided|||Null hypothesis is that duloxetine treatment effect on pain reduction in diabetic peripheral neuropathic pain (DPNP) is not maintained, as indicated by an increase of more than 1.5 point on the BPI 24-hour average pain scale. Null hypothesis is rejected at significance level 0.025 if the upper bound of one-sided 97.5% CI is less than or equal to non-inferiority margin of 1.5 point.||0.79|0.35|<0.001
73895750|NCT00322621|147324939|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||t-test, 2 sided|||||||0.269
73806899|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.18|STANDARD_ERROR_OF_MEAN|0.37||0.6|TWO_SIDED|95.0|0.63|2.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||2.20|0.63|0.60
73806900|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.25|STANDARD_ERROR_OF_MEAN|0.4||0.48|TWO_SIDED|95.0|0.67|2.33||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||2.33|0.67|0.48
73806901|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.36||0.62|TWO_SIDED|95.0|0.34|1.91||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.91|0.34|0.62
73806902|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.04|STANDARD_ERROR_OF_MEAN|1.93||0.079|TWO_SIDED|95.0|0.88|10.52||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||10.52|0.88|0.079
73806903|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.95||0.1|TWO_SIDED|95.0|0.87|5.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||5.12|0.87|0.10
73806904|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.38|STANDARD_ERROR_OF_MEAN|0.68||0.52|TWO_SIDED|95.0|0.52|3.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||3.61|0.52|0.52
73806905|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.32|STANDARD_ERROR_OF_MEAN|0.59||0.54|TWO_SIDED|95.0|0.55|3.17||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.17|0.55|0.54
73895751|NCT00322621|147324940|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73895752|NCT00322621|147324941|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.160
73895753|NCT00322621|147324942|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
73895754|NCT00322621|147324943|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||t-test, 2 sided|||||||0.075
73895755|NCT00322621|147324944|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73895756|NCT00322621|147324945|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||t-test, 2 sided|||||||0.026
73806906|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.88|STANDARD_ERROR_OF_MEAN|1.21||0.33|TWO_SIDED|95.0|0.53|6.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||6.61|0.53|0.33
73806907|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.53|STANDARD_ERROR_OF_MEAN|1.08||0.55|TWO_SIDED|95.0|0.38|6.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||6.11|0.38|0.55
73806908|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.61|STANDARD_ERROR_OF_MEAN|0.39||0.44|TWO_SIDED|95.0|0.18|2.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.14|0.18|0.44
73806909|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.29|STANDARD_ERROR_OF_MEAN|0.28||0.251|TWO_SIDED|95.0|0.84|1.98||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation models for pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.98|0.84|0.2510
73806910|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.27|STANDARD_ERROR_OF_MEAN|0.28||0.2822|TWO_SIDED|95.0|0.82|1.95||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.95|0.82|0.2822
73806911|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.34|STANDARD_ERROR_OF_MEAN|0.42||0.3558|TWO_SIDED|95.0|0.72|2.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for multiple imputation models for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||2.47|0.72|0.3558
73806912|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.36|STANDARD_ERROR_OF_MEAN|0.43||0.3291|TWO_SIDED|95.0|0.73|2.51||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||2.51|0.73|0.3291
73895757|NCT00322621|147324946|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||||||0.011
73895758|NCT00322621|147324947|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||t-test, 2 sided|||||||0.406
73895759|NCT00322621|147324948|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||t-test, 2 sided|||||||0.021
73895760|NCT00322621|147324949|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||t-test, 2 sided|||||||0.124
73895761|NCT00322621|147324950|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||t-test, 2 sided|||||||0.505
73895762|NCT00322621|147324951|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||t-test, 2 sided|||||||0.058
73806913|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.39||0.7818|TWO_SIDED|95.0|0.38|2.09||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||2.09|0.38|0.7818
73806914|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.87|STANDARD_ERROR_OF_MEAN|1.79||0.0912|TWO_SIDED|95.0|0.84|9.73||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||9.73|0.84|0.0912
73806915|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.94|STANDARD_ERROR_OF_MEAN|0.87||0.1361|TWO_SIDED|95.0|0.81|4.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||4.66|0.81|0.1361
73806916|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.58||0.72|TWO_SIDED|95.0|0.46|3.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||3.07|0.46|0.7200
73806917|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.48|STANDARD_ERROR_OF_MEAN|0.66||0.3737|TWO_SIDED|95.0|0.62|3.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.53|0.62|0.3737
73806918|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.58|STANDARD_ERROR_OF_MEAN|1.63||0.1345|TWO_SIDED|95.0|0.75|8.9||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||8.90|0.75|0.1345
73806919|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.96|STANDARD_ERROR_OF_MEAN|1.36||0.3318|TWO_SIDED|95.0|0.5|7.67||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||7.67|0.50|0.3318
73895763|NCT00322621|147324952|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
73895764|NCT00322621|147324953|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
73895765|NCT00322621|147324954|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||||||0.022
73806920|NCT04075682|147163193|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.49||0.7017|TWO_SIDED|95.0|0.23|2.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.70|0.23|0.7017
73806921|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.47|STANDARD_ERROR_OF_MEAN|0.7||0.001|TWO_SIDED|95.0|1.42|4.31||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||4.31|1.42|0.001
73806922|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.89|STANDARD_ERROR_OF_MEAN|0.54||0.025|TWO_SIDED|95.0|1.09|3.3||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||3.30|1.09|0.025
73806923|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.37|STANDARD_ERROR_OF_MEAN|0.56||0.44|TWO_SIDED|95.0|0.62|3.06||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||3.06|0.62|0.44
73806924|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.73||0.15|TWO_SIDED|95.0|0.81|3.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||3.97|0.81|0.15
73806925|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.67||0.76|TWO_SIDED|95.0|0.39|3.58||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||3.58|0.39|0.76
73806926|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.63||0.77|TWO_SIDED|95.0|0.16|3.8||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.80|0.16|0.77
73895766|NCT00322621|147324955|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||||||0.550
73895767|NCT00322621|147324956|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||t-test, 2 sided|||||||0.752
73895768|NCT00322621|147324957|SUPERIORITY_OR_OTHER|||||||0.713||95.0|||||t-test, 2 sided|||||||0.713
73895769|NCT00322621|147324958|SUPERIORITY_OR_OTHER|||||||0.066||95.0|||||t-test, 2 sided|||||||0.066
73895770|NCT00322621|147324959|SUPERIORITY_OR_OTHER|||||||0.711||95.0|||||t-test, 2 sided|||||||0.711
73895771|NCT00322621|147324960|SUPERIORITY_OR_OTHER|||||||0.678||95.0|||||t-test, 2 sided|||||||0.678
73895772|NCT00322621|147324961|SUPERIORITY_OR_OTHER|||||||0.216||95.0|||||t-test, 2 sided|||||||0.216
73806927|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.18|STANDARD_ERROR_OF_MEAN|1.23||0.17|TWO_SIDED|95.0|0.72|6.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||6.61|0.72|0.17
73806928|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.46|STANDARD_ERROR_OF_MEAN|0.29||0.22|TWO_SIDED|95.0|0.14|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.57|0.14|0.22
73806929|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.45|STANDARD_ERROR_OF_MEAN|1.94||0.02|TWO_SIDED|95.0|1.15|10.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||10.37|1.15|0.02
73806930|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|5.45|STANDARD_ERROR_OF_MEAN|4.4||0.04|TWO_SIDED|95.0|1.12|26.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||26.53|1.12|0.04
73806931|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.53||0.56|TWO_SIDED|95.0|0.1|3.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.47|0.10|0.56
73806932|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.55|STANDARD_ERROR_OF_MEAN|0.44||0.46|TWO_SIDED|95.0|0.11|2.68||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.68|0.11|0.46
73806933|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.58|STANDARD_ERROR_OF_MEAN|0.66||0.0002|TWO_SIDED|95.0|1.56|4.27||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||4.27|1.56|0.0002
73895773|NCT00322621|147324962|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||t-test, 2 sided|||||||0.113
73895774|NCT00322621|147324965|SUPERIORITY_OR_OTHER|||||||0.368||95.0|||||t-test, 2 sided|||||||0.368
73895775|NCT00322621|147324966|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
73895776|NCT00322621|147324967|SUPERIORITY_OR_OTHER|||||||0.666||95.0|||||t-test, 2 sided|||||||0.666
73895777|NCT00322621|147324968|SUPERIORITY_OR_OTHER|||||||0.138||95.0|||||t-test, 2 sided|||||||0.138
73806934|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.89|STANDARD_ERROR_OF_MEAN|0.48||0.0135|TWO_SIDED|95.0|1.14|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||3.12|1.14|0.0135
73806935|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.51|STANDARD_ERROR_OF_MEAN|0.56||0.2619|TWO_SIDED|95.0|0.73|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||3.12|0.73|0.2619
73806936|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.07|STANDARD_ERROR_OF_MEAN|0.76||0.0474|TWO_SIDED|95.0|1.01|4.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||4.24|1.01|0.0474
73806937|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.13|STANDARD_ERROR_OF_MEAN|0.58||0.8094|TWO_SIDED|95.0|0.42|3.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||3.07|0.42|0.8094
73806938|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.83|STANDARD_ERROR_OF_MEAN|0.6||0.7978|TWO_SIDED|95.0|0.2|3.44||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.44|0.20|0.7978
73806939|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.29|STANDARD_ERROR_OF_MEAN|1.15||0.1016|TWO_SIDED|95.0|0.85|6.15||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||6.15|0.85|0.1016
73806940|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.25||0.157|TWO_SIDED|95.0|0.15|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.36|0.15|0.1570
73895778|NCT00322621|147324969|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||t-test, 2 sided|||||||0.145
73895779|NCT00322621|147324970|SUPERIORITY_OR_OTHER|||||||0.512||95.0|||||t-test, 2 sided|||||||0.512
73806941|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.02|STANDARD_ERROR_OF_MEAN|1.53||0.0297|TWO_SIDED|95.0|1.11|8.18||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||8.18|1.11|0.0297
73806942|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|5.28|STANDARD_ERROR_OF_MEAN|3.81||0.0213|TWO_SIDED|95.0|1.28|21.73||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||21.73|1.28|0.0213
73806943|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.96|STANDARD_ERROR_OF_MEAN|0.78||0.9648|TWO_SIDED|95.0|0.2|4.74||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||4.74|0.20|0.9648
73806944|NCT04075682|147163194|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.72|STANDARD_ERROR_OF_MEAN|0.53||0.6512|TWO_SIDED|95.0||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||||0.6512
73806945|NCT04075682|147163195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.55|STANDARD_ERROR_OF_MEAN|0.66||0.41|TWO_SIDED|95.0|-0.75|1.85||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.85|-0.75|0.41
73806946|NCT04075682|147163195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.67|STANDARD_ERROR_OF_MEAN|0.96||0.08|TWO_SIDED|95.0|-3.55|0.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.21|-3.55|0.08
73806947|NCT04075682|147163195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.95||0.55|TWO_SIDED|95.0|-2.42|1.29||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.29|-2.42|0.55
73806948|NCT04075682|147163195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|1.36||0.38|TWO_SIDED|95.0|-1.47|3.86||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||3.86|-1.47|0.38
73806949|NCT04075682|147163195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|1.44||0.71|TWO_SIDED|95.0|-3.35|2.28||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||2.28|-3.35|0.71
73806950|NCT04075682|147163195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|3.21|STANDARD_ERROR_OF_MEAN|1.34||0.02|TWO_SIDED|95.0|0.59|5.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||5.83|0.59|0.02
73806951|NCT04075682|147163195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|1.94||0.98|TWO_SIDED|95.0|-3.85|3.76||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.76|-3.85|0.98
73806952|NCT04075682|147163195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-2.13|STANDARD_ERROR_OF_MEAN|2.08||0.31|TWO_SIDED|95.0|-6.2|1.95||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.95|-6.2|0.31
73806953|NCT04075682|147163195|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.93||0.68|TWO_SIDED|95.0|-4.58|2.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.97|-4.58|0.68
73895780|NCT01743001|147324977|SUPERIORITY||least-square (LS) mean difference|-4.7||||0.612|TWO_SIDED|95.0|-22.8|13.5||To control for multiplicity across the primary and secondary endpoints, all secondary endpoints were analyzed hierarchically according to order and significance as pre-specified in the protocol eliminating further adjustment for multiple comparisons.|ANCOVA|ANCOVA model included treatment group, presence of DS (yes/no), and WHO FC (II vs III/IV) as categorical factors, and baseline 6MWD value as covariate||The null hypothesis was that there was no difference between macitentan and placebo for the mean change from baseline to Week 16 in 6MWD. Null hypothesis was tested by an analysis of covariance (ANCOVA).||13.5|-22.8|0.6120
73895781|NCT01743001|147324978|SUPERIORITY||Odds Ratio (OR)|0.53||||0.145|TWO_SIDED|95.0|0.23|1.24||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|Regression, Logistic|Logistic regression model adjusted for randomized treatment group and location of cardiac defect (pre-tricupsid / post-tricupsid ) as factors.||For this secondary endpoint of WHO functional class, the improvement from baseline to Week 16 in WHO functional class was evaluated. The null hypothesis is the odds of improvement are the same in the placebo and the macitentan group.||1.24|0.23|0.1450
73806954|NCT04075682|147163196|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.3||0.45|TWO_SIDED|95.0|-0.81|0.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.36|-0.81|0.45
73806955|NCT04075682|147163196|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.25||0.5767|TWO_SIDED|95.0|-0.64|0.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.70|-0.64|0.5767
73806956|NCT04075682|147163197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.34||0.36|TWO_SIDED|95.0|-0.98|0.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.36|-0.98|0.36
73806957|NCT04075682|147163197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.67||0.63|TWO_SIDED|95.0|-1.64|0.99||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||0.99|-1.64|0.63
73806958|NCT04075682|147163197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.95||0.79|TWO_SIDED|95.0|-1.62|2.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.12|-1.62|0.79
73806959|NCT04075682|147163197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.31||0.4491|TWO_SIDED|95.0|-0.84|0.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.37|-0.84|0.4491
73806960|NCT04075682|147163197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.8713|TWO_SIDED|95.0|-1.26|1.06||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.06|-1.26|0.8713
73806961|NCT04075682|147163197|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.85||0.99|TWO_SIDED|95.0|-1.66|1.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||1.66|-1.66|0.99
73806962|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.69|STANDARD_ERROR_OF_MEAN|0.34||0.04|TWO_SIDED|95.0|0.02|1.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.37|0.02|0.04
73806963|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-1.85|0.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.11|-1.85|0.08
73806964|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.49||0.65|TWO_SIDED|95.0|-0.74|1.19||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.19|-0.74|0.65
73806965|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|0.71||0.3|TWO_SIDED|95.0|-0.66|2.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.11|-0.66|0.30
73806966|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.75||0.78|TWO_SIDED|95.0|-1.68|1.26||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.26|-1.68|0.78
73806967|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|0.69||0.03|TWO_SIDED|95.0|0.12|2.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||2.83|0.12|0.03
73895782|NCT01743001|147324979|SUPERIORITY||least-square (LS) mean difference|0.08||||0.6818||95.0|-0.29|0.44||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|ANCOVA|Adjusted for randomized treatment group, location of cardiac defect(pre-tricupsid/post-tricupsid) as factors, baseline Borg dyspnea index as covariate||The null hypothesis was that the mean change from baseline to Week 16 in the Borg dyspnea index is the same in the macitentan and in the placebo group.||0.44|-0.29|0.6818
73806968|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|1.01||0.95|TWO_SIDED|95.0|-1.92|2.04||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.04|-1.92|0.95
73806969|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.09||0.48|TWO_SIDED|95.0|-2.91|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.36|-2.91|0.48
73806970|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.0||0.37|TWO_SIDED|95.0|-2.86|1.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.07|-2.86|0.37
73806971|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|0.31||0.0192|TWO_SIDED|95.0|0.12|1.34||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.34|0.12|0.0192
73806972|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|0.45||0.186|TWO_SIDED|95.0|-1.48|0.29||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.29|-1.48|0.1860
73806973|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.44||0.3863|TWO_SIDED|95.0|-0.49|1.26||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.26|-0.49|0.3863
73806974|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.64||0.571|TWO_SIDED|95.0|-0.89|1.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.61|-0.89|0.5710
73895783|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|-1.0||||0.6431|TWO_SIDED|95.0|-5.0|3.1|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning.||3.1|-5.0|0.6431
73806975|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.73|STANDARD_ERROR_OF_MEAN|0.68||0.2797|TWO_SIDED|95.0|-2.06|0.6||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||0.60|-2.06|0.2797
73806976|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.33|STANDARD_ERROR_OF_MEAN|0.62||0.0312|TWO_SIDED|95.0|0.12|2.55||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||2.55|0.12|0.0312
73806977|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.91||0.5086|TWO_SIDED|95.0|-1.19|2.39||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.39|-1.19|0.5086
73806978|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.98||0.9474|TWO_SIDED|95.0|-1.86|1.99||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.99|-1.86|0.9474
73806979|NCT04075682|147163198|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.9||0.5018|TWO_SIDED|95.0|-2.36|1.16||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.16|-2.36|0.5018
73806980|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.39||0.25|TWO_SIDED|95.0|-0.31|1.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.21|-0.31|0.25
73806981|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.56||0.34|TWO_SIDED|95.0|-1.63|0.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.57|-1.63|0.34
73895784|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|-1.4||||0.5988|TWO_SIDED|95.0|-6.7|3.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical.||3.9|-6.7|0.5988
73806982|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.56||0.76|TWO_SIDED|95.0|-1.26|0.92||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||0.92|-1.26|0.76
73806983|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.78||0.15|TWO_SIDED|95.0|-0.42|2.63||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.63|-0.42|0.15
73806984|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|95.0|-1.66|1.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.66|-1.66|1.00
73806985|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.78||0.01|TWO_SIDED|95.0|0.38|3.43||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.43|0.38|0.01
73806986|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|1.11||0.58|TWO_SIDED|95.0|-1.56|2.8||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.80|-1.56|0.58
73806987|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|1.23||0.39|TWO_SIDED|95.0|-3.47|1.35||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.35|-3.47|0.39
73806988|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|1.12||0.45|TWO_SIDED|95.0|-3.05|1.35||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.35|-3.05|0.45
73895785|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|0.1||||0.9642|TWO_SIDED|95.0|-5.9|6.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index.||6.2|-5.9|0.9642
73806989|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.54|STANDARD_ERROR_OF_MEAN|0.34||0.1147|TWO_SIDED|95.0|-0.13|1.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.21|-0.13|0.1147
73806990|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.49||0.3721|TWO_SIDED|95.0|-1.41|0.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.53|-1.41|0.3721
73806991|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.49||0.8827|TWO_SIDED|95.0|-0.89|1.03||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.03|-0.89|0.8827
73806992|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.54|STANDARD_ERROR_OF_MEAN|0.68||0.4335|TWO_SIDED|95.0|-0.8|1.87||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.87|-0.80|0.4335
73806993|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|0.74||0.4063|TWO_SIDED|95.0|-2.07|0.84||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||0.84|-2.07|0.4063
73806994|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|0.68||0.0132|TWO_SIDED|95.0|0.35|3.03||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.03|0.35|0.0132
73806995|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.83|STANDARD_ERROR_OF_MEAN|0.98||0.3949|TWO_SIDED|95.0|-1.08|2.75||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.75|-1.08|0.3949
73895786|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|3.1||||0.1542|TWO_SIDED|95.0|-1.2|7.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions.||7.3|-1.2|0.1542
73806996|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|1.08||0.7145|TWO_SIDED|95.0|-2.5|1.72||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.72|-2.50|0.7145
73806997|NCT04075682|147163199|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.98||0.6081|TWO_SIDED|95.0||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||||0.6081
73806998|NCT04075682|147163200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.46||0.58|TWO_SIDED|95.0|-1.15|0.64||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.64|-1.15|0.58
73806999|NCT04075682|147163200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.9||0.82|TWO_SIDED|95.0|-1.98|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.57|-1.98|0.82
73807000|NCT04075682|147163200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|1.31||0.2|TWO_SIDED|95.0|-0.9|4.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||4.24|-0.90|0.20
73807001|NCT04075682|147163200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.36||0.88|TWO_SIDED|95.0|-0.77|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation analysis are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.66|-0.77|0.8800
73807002|NCT04075682|147163200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.72||0.8864|TWO_SIDED|95.0|-1.3|1.5||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.50|-1.30|0.8864
73895787|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|1.1||||0.602|TWO_SIDED|95.0|-3.1|5.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality.||5.3|-3.1|0.6020
73807003|NCT04075682|147163200|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.12|STANDARD_ERROR_OF_MEAN|1.02||0.2748|TWO_SIDED|95.0|-0.89|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.12|-0.89|0.2748
73807004|NCT04075682|147163201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.5||0.83|TWO_SIDED|95.0|0.45|2.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.||2.70|0.45|0.83
73807005|NCT04075682|147163201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.86|STANDARD_ERROR_OF_MEAN|1.34||0.03|TWO_SIDED|95.0|1.14|7.18||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||7.18|1.14|0.03
73807006|NCT04075682|147163201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.27||0.18|TWO_SIDED|95.0|0.15|1.44||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.||1.44|0.15|0.18
73807007|NCT04075682|147163201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.3||0.99|TWO_SIDED|95.0|0.08|12.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||12.57|0.08|0.99
73807008|NCT04075682|147163201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.52||0.86|TWO_SIDED|95.0|0.29|2.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.||These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.82|0.29|0.86
73807009|NCT04075682|147163201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.43||0.8045|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.||||0.8045
73895788|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|-1.4||||0.634|TWO_SIDED|95.0|-7.2|4.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning.||4.4|-7.2|0.6340
73807010|NCT04075682|147163201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.53|STANDARD_ERROR_OF_MEAN|1.01||0.0205|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||||0.0205
73807011|NCT04075682|147163201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.26||0.1918|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.||||0.1918
73807012|NCT04075682|147163201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|1.12||0.99|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||||0.99
73807013|NCT04075682|147163201|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.56|STANDARD_ERROR_OF_MEAN|1.54||0.6873|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||||0.6873
73807014|NCT04075682|147163202|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.39||0.37|TWO_SIDED|95.0|-1.12|0.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.41|-1.12|0.37
73807015|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.05||0.92|TWO_SIDED|95.0|0.9|1.1||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.10|0.90|0.92
73895789|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|-2.8||||0.3384|TWO_SIDED|95.0|-8.7|3.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional.||3.0|-8.7|0.3384
73895790|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|-2.3||||0.2704|TWO_SIDED|95.0|-6.4|1.8|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.||1.8|-6.4|0.2704
73895791|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|-0.4||||0.6431|TWO_SIDED|95.0|-2.1|1.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning (norm-based).||1.3|-2.1|0.6431
73807016|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.0|STANDARD_ERROR_OF_MEAN|0.05||0.95|TWO_SIDED|95.0|0.9|1.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.11|0.90|0.95
73807017|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.08||0.85|TWO_SIDED|95.0|0.85|1.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||1.14|0.85|0.85
73807018|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.07||0.75|TWO_SIDED|95.0|0.84|1.13||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.13|0.84|0.75
73807019|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.97|STANDARD_ERROR_OF_MEAN|0.11||0.78|TWO_SIDED|95.0|0.78|1.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.20|0.78|0.78
73807020|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.31|STANDARD_ERROR_OF_MEAN|0.22||0.11|TWO_SIDED|95.0|0.94|1.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||1.82|0.94|0.11
73807021|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.11||0.93|TWO_SIDED|95.0|0.8|1.22||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.22|0.80|0.93
73807022|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.11||0.86|TWO_SIDED|95.0|0.78|1.23||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.23|0.78|0.86
73895792|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|-0.6||||0.5988|TWO_SIDED|95.0|-2.6|1.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical (norm-based).||1.5|-2.6|0.5988
73807023|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.11||0.94|TWO_SIDED|95.0|0.81|1.22||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||1.22|0.81|0.94
73807024|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.21||0.13|TWO_SIDED|95.0|0.93|1.78||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.78|0.93|0.13
73807025|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.18||0.96|TWO_SIDED|95.0|0.7|1.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.41|0.70|0.96
73807026|NCT04075682|147163203|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.16||0.95|TWO_SIDED|95.0|0.72|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.36|0.72|0.95
73807027|NCT01665157|147163207|SUPERIORITY_OR_OTHER|||||||0.435||||||Not significant|ANOVA|||||||0.435
73807028|NCT01665157|147163208|SUPERIORITY_OR_OTHER|||||||0.046|||||||Chi-squared|||||||0.046
73807029|NCT01665157|147163208|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||"Null hypothesis: Low-residue diet package and 2L PEG vs. Self-controlled diet and 2L PEG provides same preparation quality."||||0.024
73807030|NCT01665157|147163208|SUPERIORITY_OR_OTHER|||||||0.041|||||||Chi-squared|||||||0.041
73807031|NCT01665157|147163211|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<0.01
73807032|NCT01665157|147163212|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
73807033|NCT01665157|147163213|SUPERIORITY_OR_OTHER|||||||0.025|||||||Chi-squared|||||||0.025
73807034|NCT01931475|147163226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||||-0.2|-0.80|
73807035|NCT01931475|147163227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.54|-0.19||||||||-0.19|-0.54|
73807036|NCT01931475|147163228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49|||||TWO_SIDED|95.0|-5.62|-1.35|||||Total Score|||-1.35|-5.62|
73807037|NCT01931475|147163228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||||TWO_SIDED|95.0|-1.21|-0.21|||||Pain|||-0.21|-1.21|
73807038|NCT01931475|147163228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36|||||TWO_SIDED|95.0|-3.95|-0.78|||||Physical Function|||-0.78|-3.95|
73807039|NCT01931475|147163228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.62|-0.16|||||Stiffness|||-0.16|-0.62|
73807040|NCT01931475|147163229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.41|-0.15||||||||-0.15|-0.41|
73807041|NCT01931475|147163230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||||TWO_SIDED|95.0|-1.07|-0.34|||||BPI Severity of Worst Pain|||-0.34|-1.07|
73807042|NCT01931475|147163230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.6|0.03|||||BPI Severity of Least Pain|||0.03|-0.60|
73807043|NCT01931475|147163230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.82|-0.11|||||BPI Severity of Right Now Pain|||-0.11|-0.82|
73807044|NCT01931475|147163231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-0.53|-0.02|||||BPI Interference Average Score|||-0.02|-0.53|
73807045|NCT01931475|147163231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||||TWO_SIDED|95.0|-0.94|-0.19|||||General activity|||-0.19|-0.94|
73807046|NCT01931475|147163231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.74|-0.05|||||Mood|||-0.05|-0.74|
73807047|NCT01931475|147163231|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.82|-0.11|||||Walking ability|||-0.11|-0.82|
73807048|NCT01931475|147163231|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-0.68|0.06|||||Normal work (includes both work outside the home and housework)|||0.06|-0.68|
73807049|NCT01931475|147163231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.34|0.21|||||Relations with other people|||0.21|-0.34|
73807050|NCT01931475|147163231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.57|0.14|||||Sleep|||0.14|-0.57|
73807051|NCT01931475|147163231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.4|0.27|||||Enjoyment of life|||0.27|-0.40|
73807052|NCT01931475|147163233|SUPERIORITY_OR_OTHER||Total Effect|97.49||||0.002|TWO_SIDED||||||Regression, Linear|||Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.||||0.002
73807053|NCT06175026|147163263|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.13|1.37||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the health messages would not elicit different levels of perceived message effectiveness compared to the neutral messages.||1.37|1.13|<0.001
73807054|NCT06175026|147163263|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.03|1.26||The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the environment messages would not elicit different perceived message effectiveness than the control messages.||1.26|1.03|<.001
73807055|NCT06175026|147163263|SUPERIORITY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.17|1.41||The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the health and environment messages would not elicit different perceived message effectiveness than the control messages.||1.41|1.17|<0.001
73807056|NCT06175026|147163263|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.062||0.1892|TWO_SIDED|95.0|-0.018|0.223||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||.223|-0.018|.1892
73807057|NCT06175026|147163263|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.62||0.47|TWO_SIDED|95.0|-0.17|0.08||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||.08|-.17|.47
73807058|NCT06175026|147163263|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.062||0.051|TWO_SIDED|95.0|-0.27|-0.03||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||-.03|-.27|.051
73807059|NCT04081610|147163264|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. through the incidence of AD.|Median Difference (Final Values)|0.05||||0.409|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.409
73807060|NCT04081610|147163265|NON_INFERIORITY|Compare the tolerability of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit-dose manufactured by Sophia Laboratories S.A. of C.V. using the ICO score.||||||0.442|||||||Wilcoxon (Mann-Whitney)|||||||0.442
73807061|NCT04081610|147163265|EQUIVALENCE|F=2.606, 15.926||||||0.009|||||||Wilcoxon (Mann-Whitney)|||Final vs initial Eye Comfort Index||||0.009
73807062|NCT04081610|147163265|EQUIVALENCE|F=3.051, 19.336||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Final vs initial Eye Comfort Index||||0.002
73807063|NCT04081610|147163266|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. through changes in BCVA.||||||0.904|||||||Wilcoxon (Mann-Whitney)|||||||0.904
73807064|NCT04081610|147163266|EQUIVALENCE|F=-1.414, 1.061||||||0.157|||||||Sign test|||Final vs initial VA||||0.157
73807065|NCT04081610|147163266|EQUIVALENCE|||||||1|||||||Sign test|||Final vs initial VA||||1.000
73807066|NCT04081610|147163267|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes in corneal and conjunctival staining with fluorescein.||||||1|||||||Fisher Exact|||||||1.000
73807067|NCT04081610|147163267|EQUIVALENCE|Chi-squared (2)= 6.400||||||0.041|||||||Chi-squared|||Final vs initial fluorescein staining||||0.041
73807068|NCT04081610|147163267|EQUIVALENCE|Chi-squared (2)=0.814||||||0.665|||||||Chi-squared|||||||0.665
73807069|NCT04081610|147163268|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes of corneal and conjunctival staining with lysamine green.||||||0.713|||||||Fisher Exact|||||||0.713
73807070|NCT04081610|147163268|EQUIVALENCE|Chi-squared (3)=14.345||||||0.002|||||||Chi-squared|||Final vs initial lissamine green staining||||0.002
73807071|NCT04081610|147163268|EQUIVALENCE|Chi-squared (2)=0.506||||||0.777|||||||Chi-squared|||Final vs initial lissamine green staining||||0.777
73807072|NCT04081610|147163269|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes in conjunctival hyperemia.||||||1|||||||Chi-squared, Corrected|||||||1.000
73807073|NCT04081610|147163269|EQUIVALENCE|F=4.167, 1||||||0.031|||||||Fisher Exact|||Final vs initial conjunctival hyperemia||||0.031
73807074|NCT04081610|147163269|EQUIVALENCE|No significant change was observed.||||||1|||||||Chi-squared, Corrected|||Final vs initial conjunctival hyperemia||||1.000
73807075|NCT05831644|147163286|SUPERIORITY||Mean Difference (Final Values)|-0.124||||0.1925|TWO_SIDED|90.0|-0.285|0.037|||ANOVA|||The primary endpoint (RHI score) was compared between treatments using an analysis of variance model (ANOVA) with treatment and period as fixed effects and subjects as random effect.||0.037|-0.285|0.1925
73807076|NCT05831644|147163287|SUPERIORITY||Mean Difference (Final Values)|-4.94||||0.1941|TWO_SIDED|90.0|-11.392|1.513|||ANOVA|||The secondary pharmacodynamic endpoint (AI) was analysed using a similar ANOVA model as for the primary endpoint.||1.513|-11.392|0.1941
73895793|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|0.1||||0.9642|TWO_SIDED|95.0|-2.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index (norm-based).||2.6|-2.5|0.9642
73807077|NCT04463251|147163350|OTHER||Least square means ratio|0.58|||||TWO_SIDED|95.0|0.37|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.37|
73807078|NCT04463251|147163350|OTHER||Least square means ratio|0.58|||||TWO_SIDED|95.0|0.37|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.37|
73807079|NCT04463251|147163351|OTHER||Least square means ratio|0.54|||||TWO_SIDED|95.0|0.34|0.87|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.87|0.34|
73807080|NCT04463251|147163351|OTHER||Least square means ratio|0.6|||||TWO_SIDED|95.0|0.37|0.95|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.95|0.37|
73807081|NCT04463251|147163352|OTHER||Least square means ratio|0.56|||||TWO_SIDED|95.0|0.34|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation"|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.34|
73807082|NCT04463251|147163352|OTHER||Least square means ratio|0.61|||||TWO_SIDED|95.0|0.38|0.98|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.98|0.38|
73807083|NCT04463251|147163353|OTHER||Least square means ratio|0.56|||||TWO_SIDED|95.0|0.34|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation"|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.34|
73807084|NCT04463251|147163353|OTHER||Least square means ratio|0.61|||||TWO_SIDED|95.0|0.38|0.98|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.98|0.38|
73807085|NCT04463251|147163354|OTHER||Least square means ratio|0.52|||||TWO_SIDED|95.0|0.34|0.81||||||"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."|"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|0.81|0.34|
73807086|NCT04463251|147163354|OTHER||Least square means ratio|0.48|||||TWO_SIDED|95.0|0.31|0.74|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.74|0.31|
73807087|NCT04463251|147163355|OTHER||Least square means ratio|0.47|||||TWO_SIDED|95.0|0.29|0.75|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.75|0.29|
73807088|NCT04463251|147163355|OTHER||Least square means ratio|0.47|||||TWO_SIDED|95.0|0.3|0.75|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.75|0.30|
73807089|NCT03425396|147163403|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.5|||||TWO_SIDED|95.0|-16.8|9.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.6|-16.8|
73807090|NCT03425396|147163403|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.0|||||TWO_SIDED|95.0|-27.4|1.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.2|-27.4|
73807091|NCT03425396|147163403|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.6|||||TWO_SIDED|95.0|-19.6|7.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.4|-19.6|
73807092|NCT03425396|147163403|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
73807093|NCT03425396|147163404|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-1.6|||||TWO_SIDED|95.0|-14.3|11.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||11.2|-14.3|
73807094|NCT03425396|147163404|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.7|||||TWO_SIDED|95.0|-16.8|9.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.0|-16.8|
73807095|NCT03425396|147163404|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|0.0|||||TWO_SIDED|95.0|-12.3|12.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.3|-12.3|
73807096|NCT03425396|147163404|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
73807097|NCT03425396|147163405|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.0|||||TWO_SIDED|95.0|-22.5|16.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||16.8|-22.5|
73807098|NCT03425396|147163405|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-4.7|||||TWO_SIDED|95.0|-23.3|14.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.2|-23.3|
73895794|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|1.5||||0.1542|TWO_SIDED|95.0|-0.6|3.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions (norm-based).||3.5|-0.6|0.1542
73807099|NCT03425396|147163405|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|5.7|||||TWO_SIDED|95.0|-13.0|22.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||22.6|-13.0|
73807100|NCT03425396|147163405|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||28.9|-40.4|
73807101|NCT03425396|147163406|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|1.7|||||TWO_SIDED|95.0|-10.0|13.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.4|-10.0|
73807102|NCT03425396|147163406|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|-2.9|||||TWO_SIDED|95.0|-16.2|9.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.7|-16.2|
73807103|NCT03425396|147163406|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment Difference|7.7|||||TWO_SIDED|95.0|-0.3|18.5|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||18.5|-0.3|
73807104|NCT03425396|147163406|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatm,ent difference|7.7|||||TWO_SIDED|95.0|-34.9|20.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.6|-34.9|
73807105|NCT03425396|147163407|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|0.0|||||TWO_SIDED|95.0|-12.6|12.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.6|-12.6|
73895795|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|0.6||||0.602|TWO_SIDED|95.0|-1.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality (norm-based).||2.6|-1.5|0.6020
73807106|NCT03425396|147163407|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.7|||||TWO_SIDED|95.0|-16.3|10.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||10.2|-16.3|
73807107|NCT03425396|147163407|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|6.0|||||TWO_SIDED|95.0|-4.5|17.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||17.7|-4.5|
73807108|NCT03425396|147163407|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|8.2|||||TWO_SIDED|95.0|-35.3|20.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.7|-35.3|
73807109|NCT03425396|147163408|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|-6.0|||||TWO_SIDED|95.0|-27.3|13.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.3|-27.3|
73807110|NCT03425396|147163408|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-10.6|||||TWO_SIDED|95.0|-29.2|8.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||8.6|-29.2|
73807111|NCT03425396|147163408|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment Difference|1.3|||||TWO_SIDED|95.0|-19.0|19.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||19.2|-19.0|
73807112|NCT03425396|147163408|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||28.9|-40.4|
73807113|NCT03425396|147163409|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.3|||||TWO_SIDED|95.0|-18.6|7.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.8|-18.6|
73807114|NCT03425396|147163409|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-14.8|||||TWO_SIDED|95.0|-29.6|-0.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-0.6|-29.6|
73807115|NCT03425396|147163409|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.3|||||TWO_SIDED|95.0|-23.2|4.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||4.4|-23.2|
73807116|NCT03425396|147163409|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
73807117|NCT03425396|147163410|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-0.3|||||TWO_SIDED|95.0|-13.1|12.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.7|-13.1|
73807118|NCT03425396|147163410|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.8|||||TWO_SIDED|95.0|-20.7|7.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.8|-20.7|
73807119|NCT03425396|147163410|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-1.1|||||TWO_SIDED|95.0|-15.1|11.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||11.6|-15.1|
73807120|NCT03425396|147163410|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|8.2|||||TWO_SIDED|95.0|-35.3|20.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.7|-35.3|
73807121|NCT03425396|147163411|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-6.0|||||TWO_SIDED|95.0|-27.3|13.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||13.3|-27.3|
73807122|NCT03425396|147163411|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.5|||||TWO_SIDED|95.0|-32.4|5.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||5.9|-32.4|
73807123|NCT03425396|147163411|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.0|||||TWO_SIDED|95.0|-25.7|15.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||15.6|-25.7|
73807124|NCT03425396|147163411|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||28.9|-40.4|
73807125|NCT03425396|147163412|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-21.3|||||TWO_SIDED|95.0|-44.1|-1.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-1.0|-44.1|
73807126|NCT03425396|147163412|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.9|||||TWO_SIDED|95.0|-32.2|4.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||4.9|-32.2|
73807127|NCT03425396|147163412|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-19.4|||||TWO_SIDED|95.0|-43.1|1.1|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.1|-43.1|
73807128|NCT03425396|147163412|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|6.7|||||TWO_SIDED|95.0|-43.8|23.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||23.2|-43.8|
73807129|NCT03425396|147163413|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-14.7|||||TWO_SIDED|95.0|-37.2|3.1|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||3.1|-37.2|
73807130|NCT03425396|147163413|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-15.9|||||TWO_SIDED|95.0|-34.3|1.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.2|-34.3|
73807131|NCT03425396|147163413|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-23.8|||||TWO_SIDED|95.0|-46.9|-4.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-4.3|-46.9|
73807132|NCT03425396|147163413|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|3.4|||||TWO_SIDED|95.0|-48.5|19.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||19.7|-48.5|
73807133|NCT03425396|147163414|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-20.7|||||TWO_SIDED|95.0|-45.1|6.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||6.0|-45.1|
73807134|NCT03425396|147163414|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-17.8|||||TWO_SIDED|95.0|-40.2|5.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||5.9|-40.2|
73807135|NCT03425396|147163414|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-11.4|||||TWO_SIDED|95.0|-36.8|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-36.8|
73807136|NCT03425396|147163414|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|3.3|||||TWO_SIDED|95.0|-47.0|33.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||33.2|-47.0|
73807137|NCT03425396|147163415|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.6|||||TWO_SIDED|95.0|-40.4|13.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.2|-40.4|
73807138|NCT03425396|147163415|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.6|||||TWO_SIDED|95.0|-32.7|14.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.6|-32.7|
73807139|NCT03425396|147163415|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-11.9|||||TWO_SIDED|95.0|-38.2|14.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.9|-38.2|
73807140|NCT03425396|147163415|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|1.4|||||TWO_SIDED|95.0|-50.3|30.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||30.9|-50.3|
73807141|NCT03689374|147163455|NON_INFERIORITY|The responses were analyzed using an ANCOVA with treatment as fixed factor and baseline value as a covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomized treatment, using a regression model including randomized treatment group and data from baseline and all previous visits as covariates. The prespecified non inferiority margin was 0.3%-point.|Treatment difference|-0.29|||<|0.0001|TWO_SIDED|95.0|-0.38|-0.2|||t-distributed test|The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test.||||-0.20|-0.38|<0.0001
73807142|NCT02805660|147163492|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.537|||||||Exact Test|||||||0.537
73807143|NCT02805660|147163492|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.|||||>|0.999|||||||Exact Test|||||||>0.999
73807144|NCT02805660|147163492|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.283|||||||Exact Test|||||||0.283
73807145|NCT02805660|147163492|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.025|||||||Exact Test|||||||0.025
73807146|NCT00394836|147163517|SUPERIORITY_OR_OTHER||percentage of responders|13.0|||||TWO_SIDED|95.0|4.0|31.0|||||Response rate is calculated as the number of responses divided by the number of participants treated \* 100.|||31|4|
73807147|NCT00394836|147163517|SUPERIORITY_OR_OTHER||percentage of responders|10.0|||||TWO_SIDED|95.0|5.0|19.0||||||||19|5|
73895796|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|-0.6||||0.634|TWO_SIDED|95.0|-3.1|1.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning (norm-based).||1.9|-3.1|0.6340
73807148|NCT02028767|147163535|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.57|STANDARD_ERROR_OF_MEAN|1.024||0|TWO_SIDED|90.0|94.662|102.639||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.639|94.662|0.0000
73807149|NCT02028767|147163535|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.71|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.783|102.796||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.796|94.783|<0.0001
73807150|NCT02028767|147163536|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.93|STANDARD_ERROR_OF_MEAN|1.019||0|TWO_SIDED|90.0|95.856|102.107||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.107|95.856|0.0000
73807151|NCT02028767|147163536|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.96|STANDARD_ERROR_OF_MEAN|1.019|<|0.0001|TWO_SIDED|90.0|95.877|102.15||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.150|95.877|<0.0001
73807152|NCT02028767|147163537|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.28|STANDARD_ERROR_OF_MEAN|1.023||0|TWO_SIDED|90.0|94.549|102.156||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.156|94.549|0.0000
73807153|NCT02028767|147163537|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.35|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|94.603|102.252|||ANOVA|The p-value relates to the null hypothesis of non-equivalence.|"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.252|94.603|<0.0001
73807154|NCT02780713|147163540|SUPERIORITY||Percentage|17.02|||||TWO_SIDED|95.0|11.79|24.58||||||||24.58|11.79|
73807155|NCT02780713|147163540|SUPERIORITY||Percentage|36.28|||||TWO_SIDED|95.0|23.84|55.2||||||||55.20|23.84|
73807156|NCT02780713|147163540|SUPERIORITY||Percentage|24.1|||||TWO_SIDED|95.0|16.84|34.48||||||||34.48|16.84|
73807157|NCT02780713|147163541|SUPERIORITY||Percentage|31.75|||||TWO_SIDED|95.0|25.77|39.12||||||||39.12|25.77|
73807158|NCT02780713|147163541|SUPERIORITY||Percentage|54.17|||||TWO_SIDED|95.0|42.16|69.6||||||||69.60|42.16|
73807159|NCT02780713|147163541|SUPERIORITY||Pecentage|41.23|||||TWO_SIDED|95.0|34.79|48.86||||||||48.86|34.79|
73807160|NCT02225860|147163553|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||"The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (delta) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately."||||<0.01
73807161|NCT02225860|147163554|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||"The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (delta) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately."||||<0.01
73807162|NCT05338502|147163556|SUPERIORITY||Geometric Least Squares Mean (LSM) Ratio|0.9|||||TWO_SIDED|90.0|0.797|1.02|||ANOVA|||Fasted State||1.02|0.797|
73807163|NCT05338502|147163556|SUPERIORITY||Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.876|1.12|||ANOVA|||Fed state||1.12|0.876|
73807164|NCT05338502|147163557|SUPERIORITY||Geometric LS Mean Ratio|0.932|||||TWO_SIDED|90.0|0.829|1.05|||ANOVA|||Fasted state||1.05|0.829|
73807165|NCT05338502|147163557|SUPERIORITY||Geometric LS Mean Ratio|1.0|||||TWO_SIDED|90.0|0.888|1.13|||ANOVA|||Fed State||1.13|0.888|
73807166|NCT05338502|147163559|SUPERIORITY||Geometric LS Mean Ratio|0.818|||||TWO_SIDED|90.0|0.68|0.985|||ANOVA|||Fasted State||0.985|0.680|
73807167|NCT05338502|147163559|SUPERIORITY||Geometric LS Mean Ratio|0.782|||||TWO_SIDED|90.0|0.645|0.949|||ANOVA|||Fed state||0.949|0.645|
73807168|NCT01250873|147163572|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.17|||||TWO_SIDED|90.0|1.06|1.3|||ANOVA|||||1.30|1.06|
73807169|NCT01250873|147163573|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.14|||||TWO_SIDED|90.0|1.01|1.28|||ANOVA|||||1.28|1.01|
73807170|NCT01250873|147163574|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8281|TWO_SIDED|90.0|-0.5|1.0|||Wilcoxon (Mann-Whitney)|||||1.00|-0.50|0.8281
73807171|NCT01250873|147163575|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.27|||||TWO_SIDED|90.0|1.17|1.39|||ANOVA|||||1.39|1.17|
73807172|NCT01250873|147163576|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.22|||||TWO_SIDED|90.0|1.1|1.36|||ANOVA|||||1.36|1.10|
73807173|NCT01250873|147163577|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.3125|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|0.00|0.3125
73807174|NCT02278939|147163579|SUPERIORITY|||||||0.003||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the control from baseline to 3-months||||0.003
73807175|NCT02278939|147163580|SUPERIORITY|||||||0.001||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in percent weight compared to the control from baseline to 3-months||||.001
73807176|NCT02278939|147163581|SUPERIORITY|||||||0.002||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for differences in group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in BMI compared to the control from baseline to 3 months||||.002
73807177|NCT03436693|147163586|OTHER|Point Estimate|Difference(Multiple imputation method)|11.3|||||TWO_SIDED|95.0|1.2|21.5||||||||21.5|1.2|
73807178|NCT03436693|147163587|OTHER|Point Estimate|Difference(Multiple imputation method)|3.8|||||TWO_SIDED|95.0|-4.1|11.7||||||||11.7|-4.1|
73807179|NCT03436693|147163588|SUPERIORITY||Difference of LSMean|1.09||||0.351|TWO_SIDED|95.0|-1.21|3.4|||Mixed Models Analysis|||||3.40|-1.21|0.351
73807180|NCT03436693|147163589|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.293|TWO_SIDED|95.0|0.23|1.55|||Regression, Cox|||||1.55|0.23|0.293
73807181|NCT03436693|147163590|SUPERIORITY||Ratio of Geometric LSMean|0.52|||<|0.001|TWO_SIDED|95.0|0.418|0.646|||Mixed Models Analysis|||||0.646|0.418|<0.001
73807182|NCT01680861|147163591|SUPERIORITY_OR_OTHER|||||||0.32|||||||Log Rank|||||||0.32
73807183|NCT01680861|147163592|SUPERIORITY_OR_OTHER|||||||0.99|||||||Log Rank|||||||0.99
73807184|NCT01680861|147163593|SUPERIORITY_OR_OTHER|||||||1|||||||Log Rank|||||||1.0
73807185|NCT01680861|147163594|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
73807186|NCT01680861|147163595|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
73807187|NCT01680861|147163596|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
73807188|NCT02111577|147163598|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and Eastern Cooperative Oncology Group (ECOG) score (0, 1 vs 2)|Hazard Ratio (HR)|1.042||||0.596|TWO_SIDED|95.0|0.895|1.213|||Log Rank|||Stratified||1.213|0.895|0.596
73807189|NCT02111577|147163598|SUPERIORITY||Hazard Ratio (HR)|1.036||||0.648|TWO_SIDED|95.0|0.891|1.204|||Log Rank|||Unstratified||1.204|0.891|0.648
73807190|NCT02111577|147163599|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.908||||0.335|TWO_SIDED|95.0|0.746|1.105|||Log Rank|||Stratified||1.105|0.746|0.335
73807191|NCT02111577|147163599|SUPERIORITY||Hazard Ratio (HR)|0.879||||0.192|TWO_SIDED|95.0|0.725|1.067|||Log Rank|||Unstratified||1.067|0.725|0.192
73807192|NCT02111577|147163600|SUPERIORITY|Stratified by region (US vs other), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.312||||0.071|TWO_SIDED|95.0|0.976|1.762|||Log Rank|||Stratified||1.762|0.976|0.071
73807193|NCT02111577|147163600|SUPERIORITY||Hazard Ratio (HR)|1.283||||0.09|TWO_SIDED|95.0|0.961|1.712|||Log Rank|||Unstratified||1.712|0.961|0.09
73807194|NCT02111577|147163601|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.461||||0.049|TWO_SIDED|95.0|1.0|2.134|||Log Rank|||Stratified||2.134|1|0.049
73807195|NCT02111577|147163601|SUPERIORITY||Hazard Ratio (HR)|1.436||||0.053|TWO_SIDED|95.0|0.993|2.077|||Log Rank|||Unstratified||2.077|0.993|0.053
73807196|NCT02111577|147163602|SUPERIORITY|Stratified by region (US vs other) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.938||||0.501|TWO_SIDED|95.0|0.779|1.13|||Log Rank|||Stratified||1.13|0.779|0.501
73807197|NCT02111577|147163602|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.512|TWO_SIDED|95.0|0.781|1.131|||Log Rank|||Unstratified||1.131|0.781|0.512
73807198|NCT02111577|147163603|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.99||||0.886|TWO_SIDED|95.0|0.863|1.136|||Log Rank|||Stratified||1.136|0.863|0.886
73807199|NCT02111577|147163603|SUPERIORITY||Hazard Ratio (HR)|1.001||||0.992|TWO_SIDED|95.0|0.875|1.145|||Log Rank|||Unstratified||1.145|0.875|0.992
73807200|NCT02111577|147163604|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.001||||0.994|TWO_SIDED|95.0|0.847|1.184|||Log Rank|||Stratified||1.184|0.847|0.994
73807201|NCT02111577|147163604|SUPERIORITY||Hazard Ratio (HR)|1.002||||0.982|TWO_SIDED|95.0|0.851|1.18|||Log Rank|||Unstratified||1.18|0.851|0.982
73807202|NCT02111577|147163605|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.077||||0.392|TWO_SIDED|95.0|0.909|1.277|||Log Rank|||Stratified||1.277|0.909|0.392
73807203|NCT02111577|147163605|SUPERIORITY||Hazard Ratio (HR)|1.068||||0.439|TWO_SIDED|95.0|0.905|1.262|||Log Rank|||Unstratified||1.262|0.905|0.439
73807204|NCT02111577|147163606|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.03||||0.754|TWO_SIDED|95.0|0.857|1.238|||Log Rank|||Stratified||1.238|0.857|0.754
73807205|NCT02111577|147163606|SUPERIORITY||Hazard Ratio (HR)|1.009||||0.924|TWO_SIDED|95.0|0.844|1.207|||Log Rank|||Unstratified||1.207|0.844|0.924
73807206|NCT02111577|147163607|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.918||||0.732|TWO_SIDED|95.0|0.563|1.497|||Log Rank|||Stratified||1.497|0.563|0.732
73807207|NCT02111577|147163607|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.713|TWO_SIDED|95.0|0.561|1.485|||Log Rank|||Unstratified||1.485|0.561|0.713
73807208|NCT02111577|147163608|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.891||||0.694|TWO_SIDED|95.0|0.5|1.587|||Log Rank|||Stratified||1.587|0.5|0.694
73807209|NCT02111577|147163608|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.661|TWO_SIDED|95.0|0.496|1.562|||Log Rank|||Unstratified||1.562|0.496|0.661
73807210|NCT02111577|147163609|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.895||||0.111|TWO_SIDED|95.0|0.781|1.027|||Log Rank|||Stratified||1.027|0.781|0.111
73807211|NCT02111577|147163609|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.184|TWO_SIDED|95.0|0.798|1.044|||Log Rank|||Unstratified||1.044|0.798|0.184
73807212|NCT02111577|147163610|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.939||||0.46|TWO_SIDED|95.0|0.795|1.11|||Log Rank|||Stratified||1.11|0.795|0.46
73807213|NCT02111577|147163610|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.534|TWO_SIDED|95.0|0.807|1.118|||Log Rank|||Unstratified||1.118|0.807|0.534
73807214|NCT02111577|147163611|SUPERIORITY|Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Risk Ratio (RR)|0.845||||0.485|TWO_SIDED|95.0|0.528|1.355|||Log binomial model|||Stratified||1.355|0.528|0.485
73807215|NCT02111577|147163612|SUPERIORITY|Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Risk Ratio (RR)|0.92||||0.768|TWO_SIDED|95.0|0.529|1.601|||Log binomial model|||Stratified||1.601|0.529|0.768
73807216|NCT04967885|147163621|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
73807217|NCT04791319|147163665|SUPERIORITY||MH weights|7.1||||0.489|TWO_SIDED|95.0|-12.1|26.2||Threshold for significance at 0.05 level.|Chi-squared|||||26.2|-12.1|0.489
73807218|NCT04791319|147163665|SUPERIORITY||MH Weights|7.1||||0.448|TWO_SIDED|95.0|-9.4|23.7|||Chi-squared|||||23.7|-9.4|0.448
73807219|NCT04791319|147163665|SUPERIORITY||MH Weights|42.0||||0.001|TWO_SIDED|95.0|22.9|61.1|||Chi-squared|||||61.1|22.9|0.001
73807220|NCT00355147|147163706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.69|TWO_SIDED||||||Mixed Models Analysis|Adjusted for site, strata, baseline score, randomized group, month and the group by month interaction|This score represents change from baseline to six months across the groups.|This is an analysis of the outcome, Stroke Specific Quality of Life Overall Total Score.||||0.69
73807221|NCT00355147|147163706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|0.23||0.05|TWO_SIDED|||||Adjusted for site, strata, baseline value, treatment group, month of assessment, treatment group x month, random subject effect|Mixed Models Analysis||This score represents change from baseline to three months across groups.|This is an analysis of the Perceived Energy Domain within the Stroke Specific Quality of Life Measure||||0.05
73807222|NCT00355147|147163707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.66|TWO_SIDED||||||Mixed Models Analysis|Adjusted by site, strata, baseline score, treatment group, month and group by month interaction|The score is the change from baseline to six months between groups.|||||0.66
73807223|NCT00355147|147163708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.74||||0.06|TWO_SIDED|95.0|0.88|51.31|||Regression, Logistic|||||51.31|0.88|0.06
73807224|NCT00355147|147163708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45||||0.036|TWO_SIDED|95.0|1.08|10.96|||Regression, Logistic|||Within group Intervention Pre Post Comparison Compliance with Diabetes Medication||10.96|1.08|0.036
73807225|NCT00355147|147163708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.407|TWO_SIDED|95.0|0.1|2.7|||Regression, Logistic|||Within Group attention control group intervention pre post comparison compliance with Diabetes Medication||2.70|0.10|0.407
73807226|NCT00355147|147163709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.05|TWO_SIDED|95.0|0.54|4.48|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Statin Medication||4.48|0.54|0.05
73807227|NCT00355147|147163709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.98||||0.0001|TWO_SIDED|95.0|2.81|12.76|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Statin Medication||12.76|2.81|0.0001
73807228|NCT00355147|147163709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83||||0.0004|TWO_SIDED|95.0|1.83|8.01|||Regression, Logistic|||Within Group Attention Control Pre Post Comparison Compliance with Statin Medication.||8.01|1.83|0.0004
73807229|NCT00355147|147163710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.096|TWO_SIDED|95.0|0.86|6.4|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Hypertension Medication||6.40|0.86|0.096
73807230|NCT00355147|147163710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.68||||0.0004|TWO_SIDED|95.0|1.81|7.48|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Hypertension Medication||7.48|1.81|0.0004
73807231|NCT00355147|147163710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.21|TWO_SIDED|95.0|0.77|3.21|||Regression, Logistic|||Within Group Attention Group Pre Post Comparison Compliance with Hypertension Medication.||3.21|0.77|0.21
73807232|NCT02397122|147163729|SUPERIORITY|||||||0.259|||||||Mann-Whitney|||Baseline||||0.259
73807233|NCT02397122|147163729|SUPERIORITY|||||||0.097|||||||Mann-Whitney|||6 weeks||||0.097
73807234|NCT02397122|147163729|SUPERIORITY|||||||0.07||||||\<0.05|Mann-Whitney U|||6 months||||0.070
73807235|NCT02397122|147163730|SUPERIORITY|||||||0.067|||||||Mann-Whitney|||Baseline||||0.067
73807236|NCT02397122|147163730|SUPERIORITY|||||||0.13|||||||Mann-Whitney|||6 weeks||||0.130
73807237|NCT02397122|147163730|SUPERIORITY|||||||0.128||||||\<0.05|Mann-Whitney U|||6 months||||0.128
73807238|NCT02397122|147163731|SUPERIORITY|||||||0.298|||||||Mann-Whitney|||Baseline||||0.298
73807239|NCT02397122|147163731|SUPERIORITY|||||||0.152|||||||Mann-Whitney|||6 weeks||||0.152
73807240|NCT02397122|147163731|SUPERIORITY|||||||0.317||||||\<0.05|Mann-Whitney U|||6 months||||0.317
73807241|NCT02397122|147163732|SUPERIORITY|||||||0.136|||||||Mann-Whitney|||Baseline||||0.136
73807242|NCT02397122|147163732|SUPERIORITY|||||||0.041|||||||Mann-Whitney|||6 weeks||||0.041
73807243|NCT02397122|147163732|SUPERIORITY|||||||0.064||||||\<0.05|Mann-Whitney U|||6 months||||0.064
73807244|NCT02397122|147163733|SUPERIORITY|||||||0.245|||||||Mann-Whitney|||Baseline||||0.245
73807245|NCT02397122|147163733|SUPERIORITY|||||||0.099|||||||Mann-Whitney|||6 weeks||||0.099
73807246|NCT02397122|147163733|SUPERIORITY|||||||0.077|||||||Mann-Whitney U|||||||0.077
73807247|NCT02397122|147163734|SUPERIORITY|||||||0.946|||||||Mann-Whitney|||Baseline||||0.946
73807248|NCT02397122|147163734|SUPERIORITY|||||||0.001|||||||Mann-Whitney|||6 weeks||||0.001
73807249|NCT02397122|147163734|SUPERIORITY|||||||0.001||||||\<0.05|Mann-Whitney U|||6 months||||0.001
73807250|NCT00926848|147163735|SUPERIORITY||Mean Difference (Final Values)|4.0|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
73807251|NCT00926848|147163736|SUPERIORITY||Mean Difference (Final Values)|6.6|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
73807252|NCT00926848|147163737|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
73807253|NCT00926848|147163738|SUPERIORITY||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
73807254|NCT00926848|147163739|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
73807255|NCT00926848|147163740|SUPERIORITY||Mean Difference (Final Values)|0.8|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
73807256|NCT00877487|147163783|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.23|||<|0.0001|TWO_SIDED|95.0|-19.1|-11.4|||ANCOVA|||||-11.4|-19.1|<0.0001
73807257|NCT00877487|147163784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73807258|NCT00877487|147163785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
73807259|NCT02729051|147163793|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the (FF/UMEC/VI versus FF/VI+UMEC) treatment difference is above -50 milliliter (mL) then FF/UMEC/VI was to be considered non-inferior to FF/VI+UMEC.|Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.0161|||TWO_SIDED|95.0|-0.013|0.05|||||MMRM method included covariates of Baseline FEV1, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline interaction.|||0.050|-0.013|
73807260|NCT02729051|147163794|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.71|1.2|||||Analysis included covariates of treatment group, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), geographical region, visit, Baseline, Baseline by visit and treatment by visit interactions.|||1.20|0.71|
73807261|NCT02729051|147163795|OTHER||Least Square Mean Difference|-0.906|STANDARD_ERROR_OF_MEAN|0.8327|||TWO_SIDED|95.0|-2.54|0.728|||||Analysis performed using a repeated measures model with covariates of Baseline SGRQ, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline.|||0.728|-2.540|
73807262|NCT02729051|147163796|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.25|||||Include covariates of treatment group, stratum (number of long-acting bronchodilators/ day during the run-in: 0/1 or 2), geographical region, visit, Baseline dyspnea index (BDI) focal score, BDI focal score/ visit and treatment/ visit interactions.|||1.25|0.72|
73807263|NCT02729051|147163797|OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.1773|||TWO_SIDED|95.0|-0.211|0.485|||||Analysis included covariates of BDI focal score, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by BDI Focal score interactions.|||0.485|-0.211|
73807264|NCT02729051|147163798|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.68|1.12|||||Analysis was performed using a Cox proportional hazards model.|||1.12|0.68|
73807265|NCT02702388|147163799|NON_INFERIORITY|Odds ratio of ORR as of Week 24 response (18 mg vs 24 mg) along with its 95% confidence interval (CI) using the Cochran-Mantel-Haenszel (CMH) method, stratified by the randomization stratification factors. The test was performed per the 95% CI using the noninferiority margin of 0.4. Noninferiority will be declared if the lower limit of the 95% CI for the odds ratio is greater than 0.4.|Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.26|0.96||||||||0.96|0.26|
73807266|NCT04740827|147163846|SUPERIORITY||Least Squares Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.426|<|0.0001|TWO_SIDED|95.0|-3.27|-1.59|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-1.59|-3.27|<0.0001
73807267|NCT04740827|147163847|SUPERIORITY||Least Squares Mean Difference|-2.35|STANDARD_ERROR_OF_MEAN|0.425|<|0.0001|TWO_SIDED|95.0|-3.19|-1.52|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-1.52|-3.19|<0.0001
73807268|NCT04740827|147163848|SUPERIORITY||Odds Ratio (OR)|5.15|||<|0.0001|TWO_SIDED|95.0|3.02|8.79|||Regression, Logistic||Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \>2) as explanatory variables.|||8.79|3.02|<0.0001
73807269|NCT04740827|147163849|SUPERIORITY||Odds Ratio (OR)|4.82|||<|0.0001|TWO_SIDED|95.0|2.85|8.14|||Regression, Logistic||Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \>2) as explanatory variables.|||8.14|2.85|<0.0001
73807270|NCT04740827|147163850|SUPERIORITY||Least Squares Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.15|-1.42|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.42|-3.15|<0.0001
73807271|NCT04740827|147163851|SUPERIORITY||Least Squares Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|-3.05|-1.32|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.32|-3.05|<0.0001
73807272|NCT04740827|147163852|SUPERIORITY||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.43|-1.93|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.93|-3.43|<0.0001
73807273|NCT04740827|147163853|SUPERIORITY||Least Squares Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-3.36|-1.86|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.86|-3.36|<0.0001
73807274|NCT04740827|147163854|SUPERIORITY||Least Squares Mean Difference|17.67|STANDARD_ERROR_OF_MEAN|2.348|<|0.0001|TWO_SIDED|95.0|13.05|22.3|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||22.30|13.05|<0.0001
73807275|NCT04740827|147163855|SUPERIORITY||Least Squares Mean Difference|17.88|STANDARD_ERROR_OF_MEAN|2.308|<|0.0001|TWO_SIDED|95.0|13.34|22.42|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||22.42|13.34|<0.0001
73807276|NCT04740827|147163856|SUPERIORITY||Least Squares Mean Difference|-4.71|STANDARD_ERROR_OF_MEAN|0.844|<|0.0001|TWO_SIDED|95.0|-6.37|-3.05|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-3.05|-6.37|<0.0001
73807277|NCT04740827|147163857|SUPERIORITY||Least Squares Mean Difference|-4.39|STANDARD_ERROR_OF_MEAN|0.786|<|0.0001|TWO_SIDED|95.0|-5.94|-2.85|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-2.85|-5.94|<0.0001
73807278|NCT04740827|147163858|SUPERIORITY||Least Squares Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|0.912|<|0.0001|TWO_SIDED|95.0|-8.22|-4.63|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-4.63|-8.22|<0.0001
73807279|NCT02060058|147163860|OTHER|The evaluation of SVR rate was based on full-analysis-set (FAS) and modified intention-to-treat population (mITT). FAS population included subjects receiving ≥ 1 dose of any antiviral agents (boceprevir and/or PEG-IFN, and/or RBV). MITT population included subjects receiving ≥ 1 dose of boceprevir.||||||0.01|||||||Chi-squared|||||||0.01
73807280|NCT01729338|147163878|SUPERIORITY_OR_OTHER|||||||0.45||||||Compared baseline to 3 months|paired t-test|||||||0.45
73807281|NCT01729338|147163878|SUPERIORITY_OR_OTHER|||||||0.19|||||||paired t-test|compares baseline to month 5||||||0.19
73807282|NCT01729338|147163879|SUPERIORITY_OR_OTHER|||||||0.1||||||baseline, 3 month|paired t-test|||||||0.1
73807283|NCT01729338|147163879|SUPERIORITY_OR_OTHER|||||||0.09|||||||paired t-test|baseline, month 5||||||0.09
73807284|NCT00251303|147163882|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||Chi-squared|||||||0.959
73807285|NCT04532619|147163884|SUPERIORITY||Slope|0.5||||0.014|TWO_SIDED|95.0|0.1|0.89||Computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.89|0.10|0.014
73895797|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|-1.3||||0.3384|TWO_SIDED|95.0|-4.1|1.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional (norm-based).||1.4|-4.1|0.3384
73807286|NCT04532619|147163885|SUPERIORITY||Slope|-0.05||||0.8|TWO_SIDED|95.0|-0.41|0.32||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.32|-0.41|0.80
73807287|NCT04532619|147163886|SUPERIORITY||Slope|-0.29||||0.009|TWO_SIDED|95.0|-0.51|-0.07||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||-0.07|-0.51|0.009
73807288|NCT04532619|147163887|SUPERIORITY||Slope|0.17||||0.118|TWO_SIDED|95.0|-0.04|0.38||calculated p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.38|-0.04|0.118
73807289|NCT04532619|147163888|SUPERIORITY||Odds Ratio, log|-0.9|STANDARD_ERROR_OF_MEAN|0.77||0.24|TWO_SIDED|||||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology. A logistic link function was used for this binary outcome.||||.24
73807290|NCT04532619|147163889|SUPERIORITY||Slope|-1.33||||0.43|TWO_SIDED|95.0|-4.64|1.98||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||1.98|-4.64|0.43
73807291|NCT04532619|147163890|SUPERIORITY||Slope|-2.06||||0.07|TWO_SIDED|95.0|-4.27|0.15||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.15|-4.27|0.07
73807292|NCT00504725|147163895|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||We will use two way ANOVA (looking for effects due to drug and time) with a p value of 0.05 indicative of statistical significance.|ANOVA|||IL-6||||0.39
73807293|NCT00504725|147163895|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||IL-8||||0.18
73807294|NCT00504725|147163895|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||IL-10||||0.14
73807295|NCT00504725|147163896|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||||||0.37
73807296|NCT00504725|147163897|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||Baseline Pain Level Score|Fisher Exact|||||||0.44
73807297|NCT00504725|147163897|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||4 Hour Pain Level Score|Fisher Exact|||||||0.20
73807298|NCT00504725|147163897|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||24 Hour Pain Level Score|Fisher Exact|||||||0.37
73807299|NCT00504725|147163897|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||Pain Level Score at Discharge|Fisher Exact|||||||0.15
73895798|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|-1.3||||0.2704|TWO_SIDED|95.0|-3.6|1.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.||1.0|-3.6|0.2704
73895799|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|0.7||||0.4332|TWO_SIDED|95.0|-1.0|2.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Physical Component Summary Score.||2.3|-1.0|0.4332
73895800|NCT01743001|147324980|SUPERIORITY||least-square (LS) mean difference|-1.1||||0.3416|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Mental Component Summary Score.||1.2|-3.4|0.3416
73807300|NCT01435018|147163898|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in ET+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically relevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-30.3|||||TWO_SIDED|95.0|-52.3|-8.3|||||Confidence interval (CI) estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights. CI stratified by country was not performed due to small number of observations.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.||-8.3|-52.3|
73807301|NCT01435018|147163899|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-19.8|||||TWO_SIDED|95.0|-32.3|-7.4|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.||-7.4|-32.3|
73807302|NCT01435018|147163899|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-20.1|||||TWO_SIDED|95.0|-32.2|-7.9|||||Confidence interval estimation was stratified by country using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative PFS rate with 95% two-sided confidence interval.||-7.9|-32.2|
73807303|NCT01435018|147163900|OTHER||Cumulative rate difference|14.7|||||TWO_SIDED|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.||31.4|-1.9|
73807304|NCT01435018|147163901|OTHER||Cumulative rate difference|8.4|||||TWO_SIDED|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.||17.2|-0.4|
73807305|NCT01435018|147163903|OTHER||Cumulative rate difference|16.3|||||TWO_SIDED|95.0|3.7|28.8||||||Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of IERC-confirmed KS progression with 95% two-sided confidence interval.|Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|28.8|3.7|
73807306|NCT01435018|147163904|OTHER||Cumulative rate difference|-15.0|||||TWO_SIDED|95.0|-34.4|4.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.||4.3|-34.4|
73807307|NCT01435018|147163905|OTHER||Cumulative rate difference|-3.3|||||TWO_SIDED|95.0|-13.3|6.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.||6.6|-13.3|
73807308|NCT01435018|147163906|OTHER||Cumulative rate difference|4.3|||||TWO_SIDED|95.0|-1.9|10.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.||10.6|-1.9|
73807309|NCT01435018|147163907|OTHER||Cumulative rate difference|5.5|||||TWO_SIDED|95.0|-0.1|11.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.||11.0|-0.1|
73807310|NCT01435018|147163910|OTHER||Cumulative rate difference|19.4|||||TWO_SIDED|95.0|-4.1|43.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.||43.0|-4.1|
73807311|NCT01435018|147163911|OTHER||Cumulative rate difference|14.4|||||TWO_SIDED|95.0|1.8|27.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.||27.0|1.8|
73807312|NCT01435018|147163912|OTHER||Cumulative rate difference|24.2|||||TWO_SIDED|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.||47.4|0.9|
73807313|NCT01435018|147163913|OTHER||Cumulative rate difference|18.8|||||TWO_SIDED|95.0|6.3|31.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.||31.3|6.3|
73807314|NCT01435018|147163914|OTHER||Cumulative rate difference|24.2|||||TWO_SIDED|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.||47.4|0.9|
73807315|NCT01435018|147163915|OTHER||Cumulative rate difference|17.7|||||TWO_SIDED|95.0|6.2|29.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.||29.3|6.2|
73807316|NCT01435018|147163916|OTHER||Cumulative rate difference|37.5|||||TWO_SIDED|95.0|13.6|61.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.||61.4|13.6|
73807317|NCT01435018|147163917|OTHER||Cumulative rate difference|11.1|||||TWO_SIDED|95.0|-0.4|22.7|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.||22.7|-0.4|
73807318|NCT01435018|147163918|OTHER||Cumulative rate difference|14.7|||||TWO_SIDED|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.||31.4|-1.9|
73807319|NCT01435018|147163919|OTHER||Cumulative rate difference|8.4|||||TWO_SIDED|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.||17.2|-0.4|
73807320|NCT01435018|147163920|OTHER||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|1.1|3.4|||||Hazard ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||3.4|1.1|
73807321|NCT01435018|147163921|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|1.1|2.2|||||Hazard ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||2.2|1.1|
73807322|NCT01435018|147163922|OTHER||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.1|0.7|||||Odds ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||0.7|0.1|
73807323|NCT01435018|147163923|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Odds ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count and country.|||1.3|0.5|
73807324|NCT00769067|147163954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.657||||0.012|TWO_SIDED|95.0|0.472|0.914||2-Sided.|Log Rank|Adjusted for the stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|"Total 128 events (progression/death) provided 80% power to detect a hazard ratio (HR) of 1.45 (Erlotinib versus Dacomitinib arm) with 1-sided alpha=0.10.This represented a 45% improvement in true median PFS.~HR and 95% confidence interval estimated from stratified Cox Regression;2-sided p-value was based on stratified log-rank test with epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG) as stratification factors"||0.914|0.472|0.012
73807325|NCT00769067|147163955|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||2-Sided.|Chi-squared|Unadjusted.||||||0.011
73807326|NCT00769067|147163958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.822||||0.252|TWO_SIDED|95.0|0.587|1.151||2-Sided.|Log Rank|Adjusted by stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|HR and its 95% confidence interval were estimated from stratified Cox Regression and 2-sided p-value was based on the stratified log-rank test with EGFR status, KRAS status and baseline ECOG as stratification factors.||1.151|0.587|0.252
73807327|NCT03806933|147163959|OTHER||Hazard Ratio (HR)|1.03|||=|0.881|TWO_SIDED|95.0|0.7|1.51||P-values were based on Wald Chi-Square tests for hazard ratios.|Wald Chi-square test||Hazard ratio (HR) was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||1.51|0.7|= 0.881
73807328|NCT03806933|147163959|OTHER||Hazard Ratio (HR)|0.72|||=|0.089|TWO_SIDED|95.0|0.49|1.05||P-values were based on Wald Chi-Square tests for hazard ratios.|Wald Chi-square test||HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||1.05|0.49|= 0.089
73807329|NCT03806933|147163959|OTHER||Hazard Ratio (HR)|0.56||||0.0035|TWO_SIDED|95.0|0.38|0.83|||Wald Chi-square test|P-values were based on Wald Chi-Square tests for hazard ratios.|HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||0.83|0.38|0.0035
73807330|NCT03625466|147163971|SUPERIORITY||Mean Difference|-1.5|||||TWO_SIDED|95.0|-5.5|2.6||||||||2.6|-5.5|
73807331|NCT01058993|147163981|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Student t-test-comparison means of normal subjects \& controls.||||||<0.05
73807332|NCT01058993|147163981|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Ratio paired t-test|Ratio paired t-test for comparison of baselines and responses for each category of leukocytes||The patients' leukocyte counts before and after plerixafor were compared.||||<0.05
73807333|NCT02632409|147164009|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0008|TWO_SIDED|98.22|0.55|0.9|||Stratified Cox Proportional hazard model|||||0.90|0.55|0.0008
73807334|NCT02632409|147164010|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0005|TWO_SIDED|98.72|0.35|0.84|||Stratified Cox Proportional hazard model|||||0.84|0.35|0.0005
73807335|NCT03521115|147164032|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.01|TWO_SIDED||||||Regression, Logistic|b=-.91, controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
73807336|NCT03521115|147164032|SUPERIORITY||Odds Ratio (OR)|0.58|||<|0.1|TWO_SIDED||||||Regression, Logistic||Controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.10
73807337|NCT03521115|147164032|SUPERIORITY||Chi-Square|5.129||||0.077|TWO_SIDED||||||Chi-squared|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||.077
73807338|NCT03521115|147164033|SUPERIORITY||b|-0.47|||<|0.001|TWO_SIDED||||||Regression, Linear|Controled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.001
73807339|NCT03521115|147164033|SUPERIORITY||b|-0.97|||<|0.01|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
73807340|NCT03521115|147164033|SUPERIORITY||F|0.85|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
73807341|NCT03521115|147164034|SUPERIORITY||b|-0.22|||<|0.1|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.10
73807342|NCT03521115|147164034|SUPERIORITY||b|-0.24|||<|0.05|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
73807343|NCT03521115|147164034|SUPERIORITY||F|0.43|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
73807344|NCT03521115|147164035|SUPERIORITY||b|-0.16|||<|0.1|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<.10
73807345|NCT03521115|147164035|SUPERIORITY||b|-0.26|||<|0.05|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
73807346|NCT03521115|147164035|SUPERIORITY||F|1.55|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
73807347|NCT03521115|147164036|SUPERIORITY||b|-0.35|||<|0.05|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
73807348|NCT03521115|147164036|SUPERIORITY||b|-0.02|||>|0.1|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
73807349|NCT03521115|147164037|SUPERIORITY||b|0.299|||<|0.01|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
73807350|NCT03521115|147164038|SUPERIORITY||b|0.268|||<|0.03|TWO_SIDED||||||generalized estimating equations|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<.03
73807351|NCT03521115|147164039|SUPERIORITY||b|0.075|||>|0.1|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
73807352|NCT03521115|147164040|SUPERIORITY||b|0.051|||>|0.1|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
73807353|NCT03521115|147164041|SUPERIORITY||b|0.72|||<|0.05|TWO_SIDED||||||generalized estimating equations|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
73807354|NCT03521115|147164042|SUPERIORITY||||||>|0.1|||||||Chi-squared|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
73807355|NCT04501640|147164043|OTHER||Geomteric Least Squares (LS) Mean Ratio|57.06|||||TWO_SIDED|90.0|46.21|70.47|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an analysis of variance (ANOVA) performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||70.47|46.21|
73807356|NCT04501640|147164043|OTHER||Geometric LSMean Ratio|61.42|||||TWO_SIDED|90.0|52.06|72.47|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||72.47|52.06|
73807357|NCT04501640|147164044|OTHER||Geomteric LSMean Ratio|53.31|||||TWO_SIDED|90.0|43.02|66.05|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||66.05|43.02|
73807358|NCT04501640|147164044|OTHER||Geomteric LSMean Ratio|59.14|||||TWO_SIDED|90.0|49.48|70.7|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||70.70|49.48|
73807359|NCT04501640|147164045|OTHER||Geometric LSMean Ratio|38.93|||||TWO_SIDED|90.0|26.78|56.59|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||56.59|26.78|
73807360|NCT04501640|147164045|OTHER||Geometric LSMean Ratio|47.9|||||TWO_SIDED|90.0|31.76|72.24|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||72.24|31.76|
73807361|NCT01981954|147164047|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 MCC Analysis||||<0.001
73807362|NCT01981954|147164049|OTHER|||||||0.003||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline=0.|t-test, 2 sided|||Week 24 Analysis||||0.003
73807363|NCT01981954|147164050|OTHER|||||||0.744||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.744
73807364|NCT01981954|147164051|OTHER|||||||0.352||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.352
73807365|NCT01981954|147164052|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||<0.001
73807366|NCT01981954|147164053|OTHER|||||||0.177||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.177
73807367|NCT01981954|147164054|OTHER|||||||0.025||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analyis||||0.025
73807368|NCT01981954|147164055|OTHER|||||||0.05||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.050
73807369|NCT01981954|147164056|OTHER|||||||0.567||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.567
73807370|NCT01981954|147164057|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
73807371|NCT01981954|147164058|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||<0.001
73807372|NCT01981954|147164059|OTHER|||||||0.004||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.004
73807373|NCT01981954|147164060|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
73807374|NCT01981954|147164061|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
73807375|NCT01981954|147164078|OTHER|||||||0.688||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.688
73807376|NCT01981954|147164079|OTHER|||||||0.61||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.610
73807377|NCT01981954|147164080|OTHER|||||||0.562||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.562
73807378|NCT01981954|147164081|OTHER|||||||0.657||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.657
73807379|NCT01981954|147164082|OTHER|||||||0.631||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.631
73807380|NCT01981954|147164083|OTHER|||||||0.41||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.410
73807381|NCT01981954|147164084|OTHER|||||||0.94||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.940
73807382|NCT01981954|147164085|OTHER|||||||1||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||1.000
73807383|NCT01981954|147164086|OTHER|||||||0.575||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|t-test, 2 sided|||Week 24 Analysis||||0.575
73807384|NCT01981954|147164087|OTHER|||||||0.031||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.031
73807385|NCT01981954|147164088|OTHER|||||||0.721||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.721
73807386|NCT03655470|147164089|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.07||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||.30
73807387|NCT03063086|147164097|SUPERIORITY||Mean Difference (Final Values)|0.172|||<|0.0001|TWO_SIDED|95.0|0.137|0.208|||Mixed Models Analysis|||||0.208|0.137|<0.0001
73807388|NCT03063086|147164097|SUPERIORITY||Median Difference (Final Values)|0.159|||<|0.0001|TWO_SIDED|95.0|0.123|0.195|||Mixed Models Analysis|||||0.195|0.123|<0.0001
73807389|NCT03063086|147164102|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.0001|TWO_SIDED|95.0|0.086|0.161|||Mixed Models Analysis|||||0.161|0.086|<0.0001
73807390|NCT04590586|147164108|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6672|TWO_SIDED|95.0|0.59|2.35|||Stratified log-rank test|Stratified by baseline score of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), and geographic region.|Hazard ratio (Lanadelumab vs. placebo) from a Cox regression model including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||2.35|0.59|0.6672
73807391|NCT04590586|147164109|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8779|TWO_SIDED|95.0|0.77|1.24|||Stratified log-rank test|Stratified by baseline score of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), and geographic region.|Hazard ratio (apremilast vs. placebo) from a Cox regression model including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.24|0.77|0.8779
73807392|NCT04590586|147164121|OTHER||Risk Difference (RD)|-4.0||||0.3773|TWO_SIDED|95.0|-12.9|4.9|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||4.9|-12.9|0.3773
73807393|NCT04590586|147164121|OTHER||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.52|1.28|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.28|0.52|
73807394|NCT04590586|147164122|OTHER||Risk Difference (RD)|-2.9||||0.4846|TWO_SIDED|95.0|-11.2|5.3|||Regression, Logistic||Risk difference is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||5.3|-11.2|0.4846
73807395|NCT04590586|147164122|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.51|1.37|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.37|0.51|
73895801|NCT01565343|147324983|SUPERIORITY_OR_OTHER||ICC|0.9893||||||95.0|||||ICC|||Intra-class Correlation Coefficient (ICC) of AD subjects 50-70 min test vs. retest values||||
73807396|NCT04590586|147164123|OTHER||Risk Difference (RD)|0.2||||0.9665|TWO_SIDED|95.0|-7.3|7.6|||Regression, Logistic||Risk difference is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||7.6|-7.3|0.9665
73807397|NCT04590586|147164123|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.59|1.74|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.74|0.59|
73807398|NCT04590586|147164124|OTHER||Odds Ratio (OR)|1.02||||0.9119|TWO_SIDED|95.0|0.71|1.46|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 8||1.46|0.71|0.9119
73807399|NCT04590586|147164124|OTHER||Odds Ratio (OR)|1.09||||0.6475|TWO_SIDED|95.0|0.75|1.58|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 15||1.58|0.75|0.6475
73807400|NCT04590586|147164124|OTHER||Odds Ratio (OR)|0.98||||0.9071|TWO_SIDED|95.0|0.64|1.48|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 29||1.48|0.64|0.9071
73807401|NCT04590586|147164125|OTHER||Odds Ratio (OR)|1.15||||0.4507|TWO_SIDED|95.0|0.8|1.66|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.66|0.80|0.4507
73807402|NCT04590586|147164126|OTHER||Odds Ratio (OR)|0.99||||0.9741|TWO_SIDED|95.0|0.64|1.53|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.53|0.64|0.9741
73807403|NCT04590586|147164127|OTHER||Odds Ratio (OR)|1.04||||0.8754|TWO_SIDED|95.0|0.64|1.7|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.70|0.64|0.8754
73807404|NCT04590586|147164128|OTHER||Risk Difference (RD)|0.2||||0.9695|TWO_SIDED|95.0|-8.7|9.1|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 8||9.1|-8.7|0.9695
73807405|NCT04590586|147164128|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.64|1.59|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 8||1.59|0.64|
73807406|NCT04590586|147164128|OTHER||Risk Difference (RD)|-2.4||||0.6236|TWO_SIDED|95.0|-11.9|7.1|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 15||7.1|-11.9|0.6236
73807407|NCT04590586|147164128|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.59|1.37|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 15||1.37|0.59|
73807408|NCT04590586|147164128|OTHER||Risk Difference (RD)|-6.2||||0.1664|TWO_SIDED|95.0|-14.9|2.5|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 29||2.5|-14.9|0.1664
73807409|NCT04590586|147164128|OTHER||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.45|1.15|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 29||1.15|0.45|
73807410|NCT04590586|147164129|OTHER||Risk Difference (RD)|-0.5||||0.9043|TWO_SIDED|95.0|-9.3|8.3|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||8.3|-9.3|0.9043
73807411|NCT04590586|147164129|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.62|1.54|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.54|0.62|
73807412|NCT01893281|147164142|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73807413|NCT02218736|147164145|SUPERIORITY|||||||0.0095|||||||t-test, 1 sided|||||||0.0095
73807414|NCT02218736|147164146|SUPERIORITY|||||||0.0345|||||||t-test, 1 sided|||||||0.0345
73807415|NCT02218736|147164147|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||||||0.430
73807416|NCT05481125|147164160|NON_INFERIORITY|Non-inferiority margin = 0.1 logMAR|Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.0125|||ONE_SIDED|95.0||-0.024||Since a non-inferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the non-inferiority margin.|||Mean difference (Clareon/Clareon Toric minus Eyhance/Eyhance Toric). Upper Confidence Limit is presented.|||-0.024||
73807417|NCT00910208|147164176|SUPERIORITY|||||||0.82|||||||ANOVA|||||||0.82
73807418|NCT00910208|147164177|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
73807419|NCT00910208|147164178|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
73807420|NCT00910208|147164179|SUPERIORITY|||||||0.033|||||||Chi-squared|||||||0.033
73807421|NCT00910208|147164180|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
73807422|NCT00910208|147164181|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73807423|NCT01598090|147164183|NON_INFERIORITY|Non-inferiority of Lambda/RBV/TVR to Alfa/RBV/TVR was not established because the lower limit of the 95% CI was less than the predefined non-inferiority margin of -12%. As a result, key secondary endpoints were not tested hierarchically to compare treatment groups.||||||0.0855||||||Non-inferiority testing is based on lower limit of confidence interval.|Mantel Haenszel|||||||0.0855
73807424|NCT00422695|147164195|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73807425|NCT00422695|147164195|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73807426|NCT01146379|147164220|SUPERIORITY_OR_OTHER|||||||0.01||||||a prior threshold for statistical significance = 0.05. P value was not corrected for multiple comparisons|Mixed Models Analysis|||The primary analysis used hierarchical linear modeling to examine the rate of change in ARAT over time. The null hypothesis was that all groups would change at a similar rate.||||.01
73807427|NCT01146379|147164220|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||This analysis then asked which groups were different from the Low Movement Dose group||||.036
73807428|NCT01146379|147164220|SUPERIORITY_OR_OTHER|||||||0.679|||||||t-test, 2 sided|||This analysis asked if the Low Movement Dose group was different from the High Movement Dose group||||0.679
73807429|NCT01146379|147164220|SUPERIORITY_OR_OTHER|||||||0.209|||||||t-test, 2 sided|||This analysis tested if the Low Movement Dose group was different from the Individual Maximum High Movement Dose group||||0.209
73807430|NCT03514485|147164263|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.34|0.25||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.25|-0.34|
73807431|NCT03514485|147164263|SUPERIORITY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.34|0.18||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.18|-0.34|
73807432|NCT03514485|147164263|SUPERIORITY||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.48|0.04||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.04|-0.48|
73807433|NCT03514485|147164263|SUPERIORITY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.44|0.9||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.9|-0.44|
73807434|NCT03514485|147164263|SUPERIORITY||Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.36|0.09||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.09|-0.36|
73807435|NCT03514485|147164264|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.39|0.55||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.55|-0.39|
73807436|NCT03514485|147164264|SUPERIORITY||Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|0.04|0.88||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.88|0.04|
73807437|NCT03514485|147164264|SUPERIORITY||Mean Difference (Net)|-0.65|||||TWO_SIDED|95.0|-1.06|-0.23||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.23|-1.06|
73807438|NCT03514485|147164264|SUPERIORITY||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-1.39|-0.67||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.67|-1.39|
73807439|NCT03514485|147164264|SUPERIORITY||Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.95|-0.18||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.18|-0.95|
73807440|NCT03514485|147164265|SUPERIORITY||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.53|0.28||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.28|-0.53|
73807441|NCT03514485|147164265|SUPERIORITY||Median Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.45|0.26||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.26|-0.45|
73807442|NCT03514485|147164265|SUPERIORITY||Mean Difference (Net)|-0.25|||||TWO_SIDED|95.0|-0.6|0.1||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.10|-0.60|
73807443|NCT03514485|147164265|SUPERIORITY||Median Difference (Net)|-0.28|||||TWO_SIDED|95.0|-0.57|0.01||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.01|-0.57|
73807444|NCT03514485|147164265|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.72|-0.04||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.04|-0.72|
73807445|NCT03514485|147164266|SUPERIORITY||Mean Difference (Net)|2.38|||||TWO_SIDED|95.0|0.58|4.19||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||4.19|0.58|
73807446|NCT03514485|147164266|SUPERIORITY||Mean Difference (Net)|4.49|||||TWO_SIDED|95.0|2.54|6.43||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||6.43|2.54|
73807447|NCT03514485|147164266|SUPERIORITY||Mean Difference (Net)|-0.97|||||TWO_SIDED|95.0|-2.78|0.84||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.84|-2.78|
73807448|NCT03514485|147164266|SUPERIORITY||Mean Difference (Net)|-3.07|||||TWO_SIDED|95.0|-5.03|-1.12||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-1.12|-5.03|
73807449|NCT03514485|147164266|SUPERIORITY||Mean Difference (Net)|1.41|||||TWO_SIDED|95.0|-0.48|3.31||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||3.31|-0.48|
73807450|NCT03514485|147164267|SUPERIORITY||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.19|0.54||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.54|-0.19|
73807451|NCT03514485|147164267|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.28|0.35||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.35|-0.28|
73807452|NCT03514485|147164267|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.68|-0.01||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.01|-0.68|
73807453|NCT03514485|147164267|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.48|0.08||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.08|-0.48|
73807454|NCT03514485|147164267|SUPERIORITY||Mean Difference (Net)|-0.17|||||TWO_SIDED|95.0|-0.48|0.14||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.14|-0.48|
73807455|NCT03514485|147164268|SUPERIORITY||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.11|0.29||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.29|-0.11|
73807456|NCT03514485|147164268|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-0.03|0.34||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.34|-0.03|
73895802|NCT01565343|147324983|SUPERIORITY_OR_OTHER||ICC|0.9574||||||95.0|||||ICC|||Intra-class Correlation Coefficient of Control subjects 50-70 min test vs. retest values||||
73807457|NCT03514485|147164268|SUPERIORITY||Mean Difference (Net)|-0.001|||||TWO_SIDED|95.0|-0.19|0.18||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.18|-0.19|
73807458|NCT03514485|147164268|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.23|0.09||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.09|-0.23|
73807459|NCT03514485|147164268|SUPERIORITY||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.09|0.26||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.26|-0.09|
73807460|NCT03514485|147164269|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|0.0|0.65||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.65|0.00|
73807461|NCT03514485|147164269|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-0.12|0.45||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.45|-0.12|
73807462|NCT03514485|147164269|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.4|0.18||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.18|-0.40|
73807463|NCT03514485|147164269|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.2|0.29||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.29|-0.20|
73807464|NCT03514485|147164269|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.08|0.5||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.50|-0.08|
73807465|NCT03514485|147164270|SUPERIORITY||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.19|0.69||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.69|-0.19|
73807466|NCT03514485|147164270|SUPERIORITY||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.14|0.63||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.63|-0.14|
73807467|NCT03514485|147164270|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.49|0.3||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.30|-0.49|
73807468|NCT03514485|147164270|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.43|0.24||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.24|-0.43|
73807469|NCT03514485|147164270|SUPERIORITY||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.24|0.54||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.54|-0.24|
73807470|NCT00791661|147164275|SUPERIORITY_OR_OTHER||Geometric mean ratio (fed/fasted)|0.92||||||95.0|||||Mixed-effect model|Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.||||||
73807471|NCT00791661|147164277|SUPERIORITY_OR_OTHER||Geometric mean ratio (fed/fasted)|0.81||||||95.0|||||Mixed-effect model|Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.||||||
73895803|NCT01565343|147324983|SUPERIORITY_OR_OTHER||Mean % difference|2.35|STANDARD_DEVIATION|1.413||||95.0||||||||Intra-subject variability (% difference) of AD subjects 50-70 min test vs. retest values||||
73895804|NCT01565343|147324983|SUPERIORITY_OR_OTHER||Mean % difference|1.49|STANDARD_DEVIATION|0.839||||95.0||||||||Intra-subject variability (% difference) of control subjects 50-70 min test vs. retest values||||
73807472|NCT00791661|147164281|SUPERIORITY_OR_OTHER||Difference in least squares mean|-8.1||||0.368|TWO_SIDED|90.0|-23.0|6.8||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 15 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||6.8|-23.0|0.368
73807473|NCT00791661|147164281|SUPERIORITY_OR_OTHER||Difference in least squares mean|-16.6||||0.079|TWO_SIDED|90.0|-32.2|-1.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 30 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-1.1|-32.2|0.079
73807474|NCT00791661|147164281|SUPERIORITY_OR_OTHER||Difference in least squares mean|-25.7||||0.007|TWO_SIDED|90.0|-40.9|-10.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 45 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-10.5|-40.9|0.007
73807475|NCT00791661|147164281|SUPERIORITY_OR_OTHER||Diffrence in least squares mean|-36.3|||<|0.001|TWO_SIDED|90.0|-52.0|-20.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-20.5|-52.0|<.001
73807476|NCT00791661|147164281|SUPERIORITY_OR_OTHER||Difference in least squares mean|-19.7||||0.147|TWO_SIDED|90.0|-42.2|2.7|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg fed minus LS mean for placebo fed.|||2.7|-42.2|0.147
73807477|NCT00791661|147164281|SUPERIORITY_OR_OTHER||Difference in least squares mean|12.3||||0.114|TWO_SIDED|90.0|-0.5|25.2|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|Difference in least squares mean (LS mean) was calculated as LS mean for MK-1006 60 mg minus LS mean for MK-1006 60 mg fed.|||25.2|-0.5|0.114
73807478|NCT00791661|147164281|SUPERIORITY_OR_OTHER||Difference in least squares mean|-28.9||||0.026|TWO_SIDED|90.0|-49.9|-7.9|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for placebo fed minus LS mean for placebo.|||-7.9|-49.9|0.026
73807479|NCT00791661|147164281|SUPERIORITY_OR_OTHER||Difference in least squares mean|-57.6|||<|0.001|TWO_SIDED|90.0|-73.3|-41.9||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 80 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-41.9|-73.3|<.001
73895805|NCT00993226|147325010|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_DEVIATION|0.29||0.467|TWO_SIDED|95.0|-0.79|0.36|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.36|-0.79|0.467
73807480|NCT00791661|147164281|SUPERIORITY_OR_OTHER||Difference in least squares mean|-15.3||||0.099|TWO_SIDED|90.0|-30.5|-0.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 100 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-0.1|-30.5|0.099
73895806|NCT00993226|147325011|SUPERIORITY||LS Mean Difference|-2.51|STANDARD_DEVIATION|2.57||0.331|TWO_SIDED|95.0|-7.59|2.58|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||2.58|-7.59|0.331
73895807|NCT01809639|147325024|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||||||.42
73895808|NCT02522624|147325052|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||<.001
73895809|NCT02522624|147325052|SUPERIORITY_OR_OTHER|||||||0.16||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.16
73895810|NCT02522624|147325052|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Controlling for Numeracy.||||<.001
73895811|NCT02522624|147325053|SUPERIORITY_OR_OTHER|||||||0.002||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||0.002
73807481|NCT00791661|147164281|SUPERIORITY_OR_OTHER||Difference in least squares mean|-43.9|||<|0.001|TWO_SIDED|90.0|-60.8|-27.0||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 140 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-27.0|-60.8|<.001
73807482|NCT00791661|147164281|SUPERIORITY_OR_OTHER||Difference in least squares mean|-59.4|||<|0.001|TWO_SIDED|90.0|-75.1|-43.7||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 170 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-43.7|-75.1|<.001
73807483|NCT02120833|147164389|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807484|NCT02120833|147164389|SUPERIORITY_OR_OTHER|||||||0.436|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.4360
73807485|NCT02120833|147164389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.62||0.051|TWO_SIDED|95.0|-2.51|0.01||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.01|-2.51|0.0510
73807486|NCT02120833|147164390|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0004
73807487|NCT02120833|147164390|SUPERIORITY_OR_OTHER|||||||0.0213|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0213
73807488|NCT02120833|147164390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.22||0.7698|TWO_SIDED|95.0|-0.5|0.37|||ANCOVA|The significance threshold level was 0.05 (two-sided).||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.37|-0.50|0.7698
73807489|NCT02120833|147164391|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0003
73807490|NCT02120833|147164391|SUPERIORITY_OR_OTHER|||||||0.6063|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6063
73807491|NCT02120833|147164391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.43||0.3686|TWO_SIDED|95.0|-1.27|0.48||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.48|-1.27|0.3686
73807492|NCT02120833|147164392|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807493|NCT02120833|147164392|SUPERIORITY_OR_OTHER|||||||0.6118|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6118
73807494|NCT02120833|147164392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.56||0.1485|TWO_SIDED|95.0|-1.98|0.31||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.31|-1.98|0.1485
73807495|NCT02120833|147164393|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807496|NCT02120833|147164393|SUPERIORITY_OR_OTHER|||||||0.2447|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.2447
73807497|NCT02120833|147164393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.67||0.0216|TWO_SIDED|95.0|-2.95|-0.25||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.25|-2.95|0.0216
73807498|NCT02120833|147164394|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807499|NCT02120833|147164394|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0476
73807500|NCT02120833|147164394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.78||0.2349|TWO_SIDED|95.0|-2.52|0.64||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.64|-2.52|0.2349
73807501|NCT02120833|147164395|SUPERIORITY_OR_OTHER|||||||0.7842|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.7842
73807502|NCT02120833|147164395|SUPERIORITY_OR_OTHER|||||||0.6083|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6083
73807503|NCT02120833|147164395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.3599|TWO_SIDED|95.0|-0.08|0.22||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.22|-0.08|0.3599
73807504|NCT02120833|147164396|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0001
73807505|NCT02120833|147164396|SUPERIORITY_OR_OTHER|||||||0.0317|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0317
73807506|NCT02120833|147164396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.19||0.8037|TWO_SIDED|95.0|-0.42|0.33||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.33|-0.42|0.8037
73807507|NCT02120833|147164397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807508|NCT02120833|147164397|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0244
73807509|NCT02120833|147164397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.21||0.09|TWO_SIDED|95.0|-0.8|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.06|-0.80|0.0900
73807510|NCT02120833|147164398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807511|NCT02120833|147164398|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0065
73807512|NCT02120833|147164398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1561|TWO_SIDED|95.0|-0.97|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.16|-0.97|0.1561
73807513|NCT02120833|147164399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807514|NCT02120833|147164399|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0049
73807515|NCT02120833|147164399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59|STANDARD_ERROR_OF_MEAN|4.71||0.2409|TWO_SIDED|95.0|-3.88|15.07||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||15.07|-3.88|0.2409
73807516|NCT02120833|147164400|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807517|NCT02120833|147164400|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.2386
73807518|NCT02120833|147164400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3|STANDARD_ERROR_OF_MEAN|3.98||0.0241|TWO_SIDED|95.0|1.28|17.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||17.32|1.28|0.0241
73807519|NCT02120833|147164401|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807520|NCT02120833|147164401|SUPERIORITY_OR_OTHER|||||||0.0696|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0696
73807521|NCT02120833|147164401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_ERROR_OF_MEAN|4.23||0.0394|TWO_SIDED|95.0|0.46|17.52||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||17.52|0.46|0.0394
73807522|NCT02120833|147164402|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807523|NCT02120833|147164402|SUPERIORITY_OR_OTHER|||||||0.0772|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0772
73807524|NCT02120833|147164402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48|STANDARD_ERROR_OF_MEAN|3.54||0.0213|TWO_SIDED|95.0|1.33|15.63||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||15.63|1.33|0.0213
73807525|NCT02120833|147164403|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807526|NCT02120833|147164403|SUPERIORITY_OR_OTHER|||||||0.0172|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0172
73807527|NCT02120833|147164403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.56|STANDARD_ERROR_OF_MEAN|3.48||0.1968|TWO_SIDED|95.0|-2.46|11.58||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||11.58|-2.46|0.1968
73807528|NCT02120833|147164404|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
73807529|NCT02120833|147164404|SUPERIORITY_OR_OTHER|||||||0.0712|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0712
73807530|NCT02120833|147164404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.43|STANDARD_ERROR_OF_MEAN|3.34||0.0313|TWO_SIDED|95.0|0.7|14.15||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||14.15|0.70|0.0313
73807531|NCT02438826|147164464|SUPERIORITY||LSMean Difference|-0.8||||0.334|TWO_SIDED|95.0|-2.77|1.17||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis|||||1.17|-2.77|0.334
73807532|NCT02438826|147164465|SUPERIORITY||Odds Ratio (OR)|1.297||||0.17|TWO_SIDED|95.0|0.83|2.028||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis|||||2.028|0.830|0.170
73807533|NCT02438826|147164466|SUPERIORITY|||||||0.946||||||Chui, Hung, Wang (CHW) procedure applied)|Mixed Models Analysis|||||||0.946
73807534|NCT02438826|147164467|SUPERIORITY||Odds Ratio (OR)|1.51||||0.057|TWO_SIDED|95.0|0.987|2.309|||Mixed Models Analysis|||||2.309|0.987|0.057
73807535|NCT02438826|147164468|SUPERIORITY||Odds Ratio (OR)|1.141||||0.713|TWO_SIDED|95.0|0.563|2.314|||Mixed Models Analysis|||||2.314|0.563|0.713
73807536|NCT02438826|147164469|SUPERIORITY||Odds Ratio (OR)|1.008||||0.979|TWO_SIDED|95.0|0.548|1.856|||Mixed Models Analysis|||||1.856|0.548|0.979
73807537|NCT02438826|147164470|SUPERIORITY||Odds Ratio (OR)|0.788||||0.437|TWO_SIDED|95.0|0.431|1.44|||Mixed Models Analysis|||||1.440|0.431|0.437
73807538|NCT00305084|147164478|OTHER||MDT|1.6|||||TWO_SIDED|||||||||All data regarding safety were registered and analyzed by descriptive analyses. Summary table were generated to document the safety|at least 3 patients per cohort had to be enrolled with expansion to 6 in presence of Dose Limiting Toxicity(DLT) (stop escalation if 2 or more DLTs at the same dose level). With a projection to achieve the highest level of NGR-hTNF, without significative toxicity (1.6 μg/m2) a planned sample of 20-25 patients was expected. DLTs were defined as: any severe toxicity clearly related to the administration of NGR-hTNF. The patient was defined assessable, according to the standard analysis, if he/she received at least one infusion of the investigational product. Maximal Tollerated Dose (MTD) was defined as the dose which produces DLTs in 2 or more patients out of 6 and will be recommended for phase II trials.|||
73807539|NCT01217476|147164577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.4039|TWO_SIDED|95.0|0.66|2.8|||Regression, Logistic|||||2.80|0.66|0.4039
73807540|NCT01217476|147164578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.52|1.56|||Regression, Logistic|||||1.56|0.52|
73807541|NCT04445714|147164585|SUPERIORITY||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.34|-1.03|||Paired t-test test|||Change from baseline||-1.03|-1.34|<.0001
73807542|NCT04445714|147164586|SUPERIORITY||Mean Difference (Final Values)|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.51|||Paired t-test test|||Change from baseline||-1.51|-2.66|<.0001
73807543|NCT04445714|147164587|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.8416|TWO_SIDED|95.0|-2.34|1.91|||Paired t-test test|||Change from baseline||1.91|-2.34|0.8416
73807544|NCT04445714|147164588|SUPERIORITY||Mean Difference (Final Values)|-24.4|||<|0.0001|TWO_SIDED|95.0|-33.4|-15.4|||Paired t-test test|||Change from baseline||-15.4|-33.4|<.0001
73807545|NCT01672710|147164589|SUPERIORITY||Mean Difference (Net)|6.9|||<|0.05|TWO_SIDED|95.0|-0.3|14.2|||ANCOVA|||||14.2|-0.3|<0.05
73807546|NCT01399047|147164595|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.105||||0.21|TWO_SIDED|95.0|-0.033|0.243|||Prescott's test||Mycophenolate was tolerated in 17/19 subjects (89.5%, 95% CI: 66.9% - 98.7%), while placebo was tolerated in 19/19 subjects (100%, 95% CI: 82.4% - 100%). The difference in tolerability rates was 10.5% (95% CI: -3.3% - 24.3%, p=0.21).|The primary outcome variable was tolerability, defined as the proportion of subjects able to complete 8 weeks on the assigned treatment. Tolerability was compared among the treatment groups using Prescott's test. A 95% confidence interval was computed for the tolerability of mycophenolate, placebo, and their difference.||0.243|-0.033|0.21
73807547|NCT01399047|147164596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69||||0.72|TWO_SIDED|95.0|-4.67|3.28|||Prescott's test|||||3.28|-4.67|0.72
73807548|NCT01399047|147164597|SUPERIORITY|||||||0.78|||||||Prescott's test|||||||0.78
73807549|NCT01399047|147164598|SUPERIORITY|||||||0.98|||||||Prescott's test|||||||0.98
73807550|NCT01399047|147164599|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
73895812|NCT02522624|147325053|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.30
73807551|NCT02046005|147164605|SUPERIORITY||Risk Ratio (RR)|1.23||||0.043|TWO_SIDED|95.0|1.01|1.51||We compared the PRE-RA group (PRE-RA arm and PRE-RA Plus arm combined) to the Comparison arm for the primary composite outcome at the 3 primary post-intervention time points using generalized estimating equations (GEE).|generalized estimating equations||PRE-RA group (combined PRE-RA arm and PRE-RA Plus arm) compared to Comparison arm (reference)|"In the primary analysis, we combined the PRE-RA and PRE-RA Plus arms into a single PRE-RA group and compared it to the Comparison arm (aka General Rheumatoid Arthritis Education)"||1.51|1.01|0.043
73807552|NCT03467217|147164608|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.95|TWO_SIDED|95.0|-30.6|32.7|||ANCOVA|Adjusted for baseline value of ALT.||||32.7|-30.6|.95
73807553|NCT03467217|147164609|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.56|TWO_SIDED|95.0|-11.0|6.0|||ANCOVA|Adjusted for baseline value of GGT.||||6.0|-11.0|0.56
73807554|NCT03467217|147164610|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.53|TWO_SIDED|95.0|-10.3|19.8|||ANCOVA|Adjusted for the baseline AST value.||||19.8|-10.3|0.53
73807555|NCT03467217|147164611|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.57|TWO_SIDED|95.0|-20.8|37.5|||ANCOVA|Adjusted for the baseline ALT value.||||37.5|-20.8|0.57
73807556|NCT03467217|147164612|SUPERIORITY|Adjusted for the baseline ALT value.|Mean Difference (Final Values)|11.6||||0.25|TWO_SIDED|95.0|9.7|36.7|||ANCOVA|||||36.7|9.7|0.25
73807557|NCT03467217|147164613|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.05|TWO_SIDED|95.0|0.0|6.8|||ANCOVA|Adjusted for the baseline HOMA-IR value.||||6.8|0.0|0.05
73807558|NCT03467217|147164614|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.64|TWO_SIDED|95.0|-1.5|2.5|||ANCOVA|Adjusted for the baseline weight value.||||2.5|-1.5|0.64
73807559|NCT03467217|147164615|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.98|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|Adjusted for the baseline BMI value.||||0.6|-0.6|0.98
73807560|NCT03467217|147164616|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.1|TWO_SIDED|95.0|-0.5|5.3|||ANCOVA|Adjusted for the baseline waist circumference value.||||5.3|-0.5|0.10
73807561|NCT03467217|147164617|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.08|TWO_SIDED|95.0|0.0|0.05|||ANCOVA|Adjusted for the baseline waist-to-hip ratio.||||0.05|0.00|0.08
73807562|NCT03467217|147164618|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.29|TWO_SIDED|95.0|-2.8|9.0|||ANCOVA|Adjusted for the baseline PedsQOL Physical Health score.||||9.0|-2.8|0.29
73807563|NCT03467217|147164619|SUPERIORITY|||||||0.17|||||||Exact conditional binomial test|||||||0.17
73807564|NCT03467217|147164620|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.64|TWO_SIDED|95.0|-13.9|8.7|||ANCOVA|Adjusted for baseline total cholesterol value.||||8.7|-13.9|0.64
73807565|NCT03467217|147164621|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.67|TWO_SIDED|95.0|-25.6|39.7|||ANCOVA|Adjusted for baseline triglyceride value.||||39.7|-25.6|0.67
73807566|NCT03467217|147164622|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.45|TWO_SIDED|95.0|-3.4|1.5|||ANCOVA|Adjusted for baseline HDL cholesterol value.||||1.5|-3.4|0.45
73807567|NCT03467217|147164623|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.93|TWO_SIDED|95.0|-10.3|9.4|||ANCOVA|Adjusted for baseline LDL cholesterol value.||||9.4|-10.3|0.93
73807568|NCT03467217|147164624|SUPERIORITY||Median Difference (Final Values)|2.9||||0.29|TWO_SIDED|95.0|-2.5|20.1|||ANCOVA|Adjusted for baseline PedsQOL Psychosocial Health score.||||20.1|-2.5|0.29
73807569|NCT03233529|147164627|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-3.1|-1.7|||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.7|-3.1|<0.0001
73807570|NCT03233529|147164628|SUPERIORITY||Least Squares Mean Difference|-0.9906|STANDARD_ERROR_OF_MEAN|0.48404||0.042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0420
73807571|NCT03233529|147164629|SUPERIORITY||Least Squares Mean Difference|-0.5446|STANDARD_ERROR_OF_MEAN|0.37855||0.1519|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.1519
73807572|NCT03233529|147164630|SUPERIORITY||Least Squares Mean Difference|-1.1273|STANDARD_ERROR_OF_MEAN|0.32552||0.0007|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0007
73807573|NCT03233529|147164631|SUPERIORITY||Least Squares Mean Difference|-0.7612|STANDARD_ERROR_OF_MEAN|0.44266||0.0871|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0871
73807574|NCT03233529|147164632|SUPERIORITY||Least Squares Mean Difference|-1.3641|STANDARD_ERROR_OF_MEAN|0.48603||0.0055|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0055
73807575|NCT03233529|147164633|SUPERIORITY||Least Squares Mean Difference|-1.1246|STANDARD_ERROR_OF_MEAN|0.49359||0.0238|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0238
73807576|NCT03233529|147164634|SUPERIORITY||Least Squares Mean Difference|-1.9913|STANDARD_ERROR_OF_MEAN|0.68659||0.0042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0042
73807577|NCT03233529|147164641|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.7|-1.4|||Mixed Models Analysis|||Crisaborole 2% was superior to vehicle if p-value was \<0.05.||-1.4|-2.7|< 0.0001
73807578|NCT03233529|147164642|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-1.3|< 0.0001
73807579|NCT03233529|147164642|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-1.4|< 0.0001
73807580|NCT03233529|147164643|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.36||0.0188|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis||Comparison at Day 2|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.1|-1.6|0.0188
73807581|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.36||0.0014|TWO_SIDED|95.0|-1.9|-0.4|||Mixed Models Analysis||Comparison at Day 3|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.4|-1.9|0.0014
73807582|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.36||0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 4|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-2.0|0.0003
73807583|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.2|-0.8|||Mixed Models Analysis||Comparison at Day 5|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-2.2|< 0.0001
73807584|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.36||0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 6|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-2.0|0.0003
73807585|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.3|-0.8|||Mixed Models Analysis||Comparison at Day 7|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-2.3|< 0.0001
73807586|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.5|-1.1|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.1|-2.5|< 0.0001
73807587|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 9|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.6|< 0.0001
73807588|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.7|-1.3|||Mixed Models Analysis||Comparison at Day 10|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.3|-2.7|< 0.0001
73807589|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis||Comparison at Day 11|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.9|-2.3|< 0.0001
73807590|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.9|-1.5|||Mixed Models Analysis||Comparison at Day 12|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.5|-2.9|< 0.0001
73807591|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 13|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.6|< 0.0001
73807592|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.4|-1.0|||Mixed Models Analysis||Comparison at Day 14|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.0|-2.4|< 0.0001
73807593|NCT03233529|147164643|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.7|-1.2|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.7|< 0.0001
73807594|NCT01177293|147164646|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|89.78|||||TWO_SIDED|90.0|82.74|97.43||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1155 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||97.43|82.74|
73807595|NCT01177293|147164647|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric mean ratio|99.73|||||TWO_SIDED|90.0|85.1|116.87||||||||116.87|85.10|
73807596|NCT01177293|147164648|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|86.67|||||TWO_SIDED|90.0|79.57|94.42||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1278 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||94.42|79.57|
73807597|NCT03214380|147164665|NON_INFERIORITY|Non-inferiority Margin = 0.4 for HbA1c|Least Square Mean Difference (LSMean)|0.06|||||TWO_SIDED|95.0|-0.05|0.16||||||||0.16|-0.05|
73807598|NCT03214380|147164666|SUPERIORITY||Mean Difference (Net)|-11.8|||<|0.001|TWO_SIDED|95.0|-18.1|-5.5|||ANCOVA|||||-5.5|-18.1|<0.001
73807599|NCT03214380|147164667|SUPERIORITY||Mean Difference (Net)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.3|-9.5|||ANCOVA|||||-9.5|-25.3|<0.001
73807600|NCT02230696|147164687|EQUIVALENCE|provides 85% power of success|Equivalence ratio|94.19|||||TWO_SIDED|90.0|84.77|104.52|||Trial and Error approach|||||104.52|84.77|
73807601|NCT02230696|147164688|EQUIVALENCE|provides 85% power of success|Equivalence ratio|94.68|||||TWO_SIDED|90.0|84.86|105.54|||Trial and Error approach|||||105.54|84.86|
73807602|NCT01905553|147164690|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||TWO_SIDED|90.0|0.67|0.77||||||||0.770|0.670|
73807603|NCT01905553|147164691|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||TWO_SIDED|90.0|0.67|0.769||||||||0.769|0.670|
73807604|NCT01905553|147164692|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.449|||||TWO_SIDED|90.0|0.38|0.53||||||||0.530|0.380|
73895813|NCT02522624|147325053|SUPERIORITY_OR_OTHER|||||||0.82|||||||Regression, Linear|||Controlling for Numeracy.||||0.82
73807605|NCT02223650|147164697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.01|TWO_SIDED|95.0|-1.42|-0.07||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline distance control pre-study spectacle wear, and pre-study IXT treatment|Difference in mean distance control (overminus - observation) and 95% CI from ANCOVA model adjusting for baseline control, pre-study spectacle wear, and pre-study treatment for IXT. + difference suggests observation group worse than overminus group|||-0.07|-1.42|0.01
73807606|NCT02223650|147164698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.14|TWO_SIDED|95.0|-0.68|0.19||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk near control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.|||0.19|-0.68|0.14
73807607|NCT02223650|147164701|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0||||0.07|TWO_SIDED|95.0|-6.0|45.0||The p-value was not adjusted for multiple comparisons.|Chi-squared|||||45|-6|0.07
73807608|NCT02223650|147164709|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.001||||0.54|TWO_SIDED|95.0|-23.0|24.0||The p-value was not adjusted for multiple comparisons.|Chi-squared|||||24|-23|0.54
73807609|NCT01683266|147164796|NON_INFERIORITY_OR_EQUIVALENCE|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.098|0.185||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.||0.185|-0.098|
73807610|NCT01683266|147164799|SUPERIORITY_OR_OTHER||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.322|||TWO_SIDED|95.0|-0.982|0.287||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; pre-injection SMPG value and pre-injection SMPG value-by-visit interaction as continuous fixed covariates.||0.287|-0.982|
73807611|NCT00626821|147164823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.813|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|95.0|1.553|2.073|||Mixed Models Analysis|||||2.073|1.553|<0.0001
73807612|NCT01062113|147164874|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|38.2|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|95.0|20.3|56.1||The difference in the efficacy rates was tested using normal distribution at a significance level of 2-sided 5%. 2-sided 95% confidence interval (CI) for the difference in the efficacy rates was calculated using normal approximation.|asymptotic z-test|||||56.1|20.3|<0.0001
73807613|NCT01062113|147164876|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
73807614|NCT01062113|147164877|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
73807615|NCT01471340|147164878|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The projected sample size provided 90% power at a 2.5% alpha level (one-sided) to determine non-inferiority of MF/F and MF. For analysis of the first SAO in participants, MF/F MDI BID was considered non-inferior to MF MDI BID if the upper bound for the 95% confidence interval (CI) of the hazard ratio (HR) of MF/F MDI BID versus MF MDI BID was lower than 2.0 (noninferiority margin).|Hazard Ratio (HR)|1.22||||0.411|TWO_SIDED|95.0|0.76|1.94|||Cox proportional-hazard model||The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAO; pooled MF/F treatments and pooled MF treatments||1.94|0.76|0.411
73807616|NCT01471340|147164879|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.021|TWO_SIDED|95.0|0.8|0.98|||Cox proportional-hazard model|Superiority of MF/F MDI BID vs MF MDI BID was determined if the HR was less than 1 and achieved statistical significance (one-sided p-value \< 0.025).|The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAEX; pooled MF/F treatments and pooled MF treatments||0.98|0.80|0.021
73807617|NCT00526669|147164884|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Biomarker: TS|Wilcoxon signed rank test|||||||0.10
73807618|NCT00526669|147164884|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||Biomarker: DPD|Wilcoxon signed rank test|||||||0.097
73807619|NCT00526669|147164884|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Biomarker: EGFR/HER1|Wilcoxon signed rank test|||||||0.10
73895814|NCT02522624|147325054|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||<.001
73807620|NCT00526669|147164884|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Biomarker: HER2|Wilcoxon signed rank test|||||||0.26
73807621|NCT00526669|147164884|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||Biomarker: HER3|Wilcoxon signed rank test|||||||0.38
73807622|NCT00526669|147164885|SUPERIORITY_OR_OTHER||percentage of participants|17.9|||||TWO_SIDED|95.0|9.6|29.2|||||The estimated value represents the percentage of participants with complete response or partial response.|||29.2|9.6|
73807623|NCT00526669|147164886|SUPERIORITY_OR_OTHER||percentage of participants|29.0|||||TWO_SIDED|95.0|17.9|40.3|||||The estimated value reflects the percentage of participants who achieved progression-free survival.|||40.3|17.9|
73807624|NCT01082211|147164953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||Chi-squared|||Assuming a 3-year rate of 25% using a chi-squared test, a sample size of 55 patients will ensure at least 90% probability of detecting a reduction in the 3-year ipsilateral in-breast recurrence rate from 25% to 9%, with a significance level of 0.05 (1-sided). In-breast recurrence will be estimated using the cumulative incidence method.||||0.0002
73807625|NCT01082211|147164961|OTHER||Effect size|0.1|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Functional status||||
73895815|NCT02522624|147325054|SUPERIORITY_OR_OTHER|||||||0.82|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.82
73807626|NCT01082211|147164961|OTHER||Effect size|0.14|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Cosmetic||||
73807627|NCT01082211|147164961|OTHER||Effect size|0.34|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Breast-specific pain||||
73807628|NCT01082211|147164962|OTHER||Effect size|0.04|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Functional status||||
73807629|NCT01082211|147164962|OTHER||Effect size|0.32|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Cosmetic||||
73807630|NCT01082211|147164962|OTHER||Effect size|0.28|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Breast-specific pain||||
73807631|NCT01082211|147164964|OTHER|||||||0.054|||||||Spearman rank-order correlation test|||||||0.054
73807632|NCT01082211|147164964|OTHER|||||||0.044|||||||Spearman rank-order correlation test|||||||0.044
73807633|NCT01082211|147164964|OTHER|||||||0.087|||||||Spearman rank-order correlation test|||||||0.087
73807634|NCT01080118|147165010|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.05||||0.001|TWO_SIDED|99.0|0.05|0.05|||t-test, 2 sided|||||.05|.05|.001
73807635|NCT01080118|147165010|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence||||||0.001||95.0|||||t-test, 2 sided|||||||.001
73807636|NCT04016779|147165012|SUPERIORITY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.28||0.004|TWO_SIDED|95.0|-6.2|-1.2|||Mixed Model for Repeated Measures|||||-1.2|-6.2|0.0040
73807637|NCT04016779|147165013|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0023|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Model for Repeated Measures|||||-0.2|-0.7|0.0023
73807638|NCT04016779|147165014|SUPERIORITY||Difference in percentage of responders|5.6||||0.303|TWO_SIDED|95.0|-5.0|16.1|||Pearson's chi-squared test|||||16.1|-5.0|0.3030
73807639|NCT04016779|147165015|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0076|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Model for Repeated Measures|||||-0.1|-0.6|0.0076
73807640|NCT04016779|147165016|SUPERIORITY||Difference in percentage of responders|10.7||||0.0744|TWO_SIDED|95.0|-1.0|22.1|||Pearson's chi-squared test|||||22.1|-1.0|0.0744
73807641|NCT04016779|147165017|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.9205|TWO_SIDED|95.0|-0.9|0.8|||Mixed Model for Repeated Measures|||||0.8|-0.9|0.9205
73807642|NCT04016779|147165018|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.77||0.0015|TWO_SIDED|95.0|-4.0|-0.9|||Mixed Model for Repeated Measures|||||-0.9|-4.0|0.0015
73807643|NCT04016779|147165019|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.66||0.038|TWO_SIDED|95.0|-2.7|-0.1|||Mixed Model for Repeated Measures|||||-0.1|-2.7|0.0380
73807644|NCT04016779|147165020|SUPERIORITY||Difference in percentage of responders|12.4||||0.0395|TWO_SIDED|95.0|0.6|23.8|||Pearson's chi-squared test|||||23.8|0.6|0.0395
73807645|NCT04016779|147165021|SUPERIORITY||Difference in percentage of responders|6.4||||0.2736|TWO_SIDED|95.0|-5.0|17.5|||Pearson's chi-squared test|||||17.5|-5.0|0.2736
73807646|NCT04016779|147165022|SUPERIORITY||Least Square Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.22||0.0468|TWO_SIDED|95.0|-4.8|0.0|||ANCOVA|||||0.0|-4.8|0.0468
73807647|NCT04016779|147165023|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.04||0.4462|TWO_SIDED|95.0|-2.8|1.3|||ANCOVA|||||1.3|-2.8|0.4462
73807648|NCT04016779|147165024|SUPERIORITY||Least Square Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.29||0.01|TWO_SIDED|95.0|-5.9|-0.8|||ANCOVA|||||-0.8|-5.9|0.0100
73807649|NCT04016779|147165025|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.16||0.2186|TWO_SIDED|95.0|-3.7|0.9|||ANCOVA|||||0.9|-3.7|0.2186
73807650|NCT04016779|147165026|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.1||0.0344|TWO_SIDED|95.0|-4.5|-0.2|||ANCOVA|||||-0.2|-4.5|0.0344
73807651|NCT04016779|147165027|SUPERIORITY||Least Square Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.99||0.368|TWO_SIDED|95.0|-1.1|2.8|||ANCOVA|||||2.8|-1.1|0.3680
73807652|NCT04016779|147165028|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.6361|TWO_SIDED|95.0|-2.7|1.6|||ANCOVA|||||1.6|-2.7|0.6361
73807653|NCT04016779|147165029|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.2||0.1708|TWO_SIDED|95.0|-4.0|0.7|||ANCOVA|||||0.7|-4.0|0.1708
73807654|NCT04016779|147165030|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.3||0.0094|TWO_SIDED|95.0|-6.0|-0.8|||ANCOVA|||||-0.8|-6.0|0.0094
73807655|NCT04016779|147165031|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.34||0.0104|TWO_SIDED|95.0|-6.1|-0.8|||ANCOVA|||||-0.8|-6.1|0.0104
73807656|NCT04016779|147165032|SUPERIORITY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.13||0.0178|TWO_SIDED|95.0|-4.9|-0.5|||ANCOVA|||||-0.5|-4.9|0.0178
73807657|NCT04016779|147165033|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|1.34||0.0187|TWO_SIDED|95.0|-5.8|-0.5|||ANCOVA|||||-0.5|-5.8|0.0187
73807658|NCT02295020|147165034|SUPERIORITY_OR_OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
73807659|NCT02295020|147165035|SUPERIORITY_OR_OTHER|||||||0.232|||||||t-test, 2 sided|||||||0.232
73807660|NCT02295020|147165036|SUPERIORITY_OR_OTHER|||||||0.311|||||||t-test, 2 sided|||||||0.311
73807661|NCT02295020|147165038|SUPERIORITY_OR_OTHER|||||||0.449|||||||t-test, 2 sided|||||||0.449
73807662|NCT02295020|147165039|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.860
73807663|NCT02295020|147165040|SUPERIORITY_OR_OTHER|||||||0.735|||||||Wilcoxon (Mann-Whitney)|||||||0.735
73807664|NCT02295020|147165041|SUPERIORITY_OR_OTHER|||||||0.479|||||||Wilcoxon (Mann-Whitney)|||||||0.479
73807665|NCT02295020|147165042|SUPERIORITY_OR_OTHER|||||||0.323|||||||Wilcoxon (Mann-Whitney)|||||||0.323
73807666|NCT02295020|147165043|SUPERIORITY_OR_OTHER|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
73895816|NCT02522624|147325054|SUPERIORITY_OR_OTHER|||||||0.15|||||||Regression, Linear|||Controlling for Numeracy.||||0.15
73895817|NCT02522624|147325055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1|TWO_SIDED|95.0|0.92|2.36||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||2.36|0.92|0.10
73807667|NCT00937040|147165063|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline AISRS total score. Change from baseline to endpoint uses the latest non-missing score after baseline for each subject.|ANCOVA|P-value for Change from baseline at endpoint. Each outcome involved with gate-keeping will be numbered with a Gate-Keeper-Sequence-Number from 01-16.||Gate-Keeper-Sequence#01. The primary efficacy was tested at the 0.05 level of significance. To control the overall Type I error at 0.05, the secondary efficacy endpoints were tested in a fixed sequence if the preceding null hypothesis was rejected. No further hypotheses could be tested when the preceding null hypothesis was not rejected. All nominal p-values were presented even though the formal testing procedure stopped at the primary endpoint. No unqualified statements can be made.||||<0.001
73807668|NCT00937040|147165064|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#02.||||0.206
73807669|NCT00937040|147165065|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#03.||||0.348
73807670|NCT00937040|147165066|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#04.||||0.324
73807671|NCT00937040|147165067|SUPERIORITY_OR_OTHER|||||||0.631||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#05.||||0.631
73807672|NCT00937040|147165068|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#06.||||<0.001
73807673|NCT00937040|147165069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#07.||||<0.001
73807674|NCT00937040|147165070|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#08.||||0.008
73807675|NCT00937040|147165071|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#09.||||0.372
73807676|NCT00937040|147165072|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#10.||||<0.001
73807677|NCT00937040|147165073|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value was determined using CMH general association controlling for pooled center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#11.||||0.008
73807678|NCT00937040|147165074|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#12.||||<0.001
73807679|NCT00937040|147165075|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#13.||||0.003
73807680|NCT00937040|147165076|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#14.||||0.016
73807681|NCT00937040|147165077|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#15.||||0.092
73895818|NCT02522624|147325055|SUPERIORITY_OR_OTHER|||||||0.26|||||||Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.26
73807682|NCT00937040|147165078|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center. Missing/unknown responses are not included in the p-value.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#16.||||0.284
73807683|NCT00937040|147165079|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||<0.001
73807684|NCT00937040|147165080|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||0.319
73807685|NCT00937040|147165081|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||0.007
73807686|NCT02805179|147165107|SUPERIORITY|Compared to historical controls||||||0.03|||||||1-sided binomial test|||||||0.03
73895819|NCT02522624|147325055|SUPERIORITY_OR_OTHER|||||||0.58|||||||Regression, Linear|||Controlling for Numeracy.||||0.58
73895820|NCT02522624|147325056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.52|||<|0.001|TWO_SIDED|95.0|1.58|4.01||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||4.01|1.58|<.001
73807687|NCT01167881|147165137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.46|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|97.5|-4.87|-4.05||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-4.05|-4.87|<0.0001
73807688|NCT01167881|147165138|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|97.5|-0.2|-0.01|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-0.01|-0.20|<0.0001
73807689|NCT01167881|147165138|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.0153|TWO_SIDED|97.5|-0.2|-0.01||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-0.01|-0.20|0.0153
73807690|NCT01167881|147165139|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.102|||<|0.0001|TWO_SIDED|97.5|0.06|0.173||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (\<8.5 / \>=8.5).||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||0.173|0.060|<0.0001
73807691|NCT01167881|147165140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|97.5|-7.0|-4.2||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-4.2|-7.0|<0.0001
73807692|NCT01167881|147165141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|97.5|-3.5|-1.8||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-1.8|-3.5|<0.0001
73807693|NCT01167881|147165142|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|97.5|-0.16|0.02|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||0.02|-0.16|<0.0001
73895821|NCT02522624|147325056|SUPERIORITY_OR_OTHER|||||||0.39||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.39
73895822|NCT02522624|147325056|SUPERIORITY_OR_OTHER|||||||0.57|||||||Regression, Linear|||Controlling for Numeracy.||||0.57
73807694|NCT01167881|147165143|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|97.5|-5.16|-4.46||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-4.46|-5.16|<0.0001
73807695|NCT01167881|147165144|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.077|||<|0.0001|TWO_SIDED|97.5|0.04|0.148||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (\<8.5 / \>=8.5).||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||0.148|0.040|<0.0001
73807696|NCT01167881|147165145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|97.5|-7.3|-4.4||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-4.4|-7.3|<0.0001
73807697|NCT01167881|147165146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|97.5|-3.7|-2.0||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-2.0|-3.7|<0.0001
73807698|NCT00986921|147165168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87||||0.05|TWO_SIDED|95.0|0.0|3.0|||t-test, 1 sided|Data was not distributed normally. After log transformation, the log values were distributed normally.||||3|0|0.05
73807699|NCT00986921|147165169|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|95.0||||A threshold value of p of 0.05 was considered significant.|Chi-squared|||The null hypothesis was that the groups would vary, with a p values of less than 0.05.||||0.49
73807700|NCT00986921|147165170|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
73807701|NCT04223635|147165177|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Interval (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|92.6|||||TWO_SIDED|90.0|54.38|157.69|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||157.69|54.38|
73807702|NCT04223635|147165179|OTHER|Least squares means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric Least Square Mean|147.17|||||TWO_SIDED|90.0|95.39|227.07|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||227.07|95.39|
73807703|NCT04223635|147165180|OTHER|Least squares means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric Least Square Mean|142.87|||||TWO_SIDED|90.0|91.21|223.79|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||223.79|91.21|
73807704|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.998|||||TWO_SIDED|95.0|2.659|6.009||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.009|2.659|
73807705|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.222|||||TWO_SIDED|95.0|0.813|1.838||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.838|0.813|
73895823|NCT02522624|147325057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.32|||<|0.001|TWO_SIDED|95.0|5.94|17.95||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||17.95|5.94|<.001
73807706|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.661|||||TWO_SIDED|95.0|0.44|0.994||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.994|0.440|
73807707|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.178|||||TWO_SIDED|95.0|1.449|3.276||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.276|1.449|
73807708|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.017|||||TWO_SIDED|95.0|0.676|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.528|0.676|
73807709|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.673|||||TWO_SIDED|95.0|0.448|1.012||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.012|0.448|
73807710|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.742|||||TWO_SIDED|95.0|1.156|2.626||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.626|1.156|
73807711|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.306|||||TWO_SIDED|95.0|0.204|0.458||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.458|0.204|
73807712|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.165|||||TWO_SIDED|95.0|0.11|0.248||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.248|0.110|
73807713|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.545|||||TWO_SIDED|95.0|0.363|0.818||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.818|0.363|
73807714|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.254|||||TWO_SIDED|95.0|0.17|0.381||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.381|0.170|
73807715|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.168|||||TWO_SIDED|95.0|0.112|0.252||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.252|0.112|
73895824|NCT02522624|147325057|SUPERIORITY_OR_OTHER|||||||0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.001
73895825|NCT02522624|147325057|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Linear|||Controlling for numeracy.||||0.46
73807716|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.436|||||TWO_SIDED|95.0|0.29|0.655||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.655|0.290|
73807717|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.541|||||TWO_SIDED|95.0|0.361|0.811||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.811|0.361|
73807718|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.783|||||TWO_SIDED|95.0|1.188|2.676||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.676|1.188|
73807719|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.832|||||TWO_SIDED|95.0|0.555|1.246||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.246|0.555|
73807720|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.551|||||TWO_SIDED|95.0|0.367|0.826||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.826|0.367|
73807721|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.426|||||TWO_SIDED|95.0|0.95|2.14||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.140|0.950|
73807722|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.295|||||TWO_SIDED|95.0|2.196|4.944||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.944|2.196|
73807723|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.538|||||TWO_SIDED|95.0|1.026|2.303||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.303|1.026|
73807724|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.018|||||TWO_SIDED|95.0|0.679|1.526||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.526|0.679|
73807725|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.635|||||TWO_SIDED|95.0|1.754|3.959||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.959|1.754|
73895826|NCT00535288|147325082|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.2|||<|0.01|TWO_SIDED|95.0|-2.2|-0.2||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.2|-2.2|<0.01
73807726|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.467|||||TWO_SIDED|95.0|0.311|0.7||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.7|0.311|
73807727|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.309|||||TWO_SIDED|95.0|0.206|0.463||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.463|0.206|
73807728|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.8|||||TWO_SIDED|95.0|0.532|1.203||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||1.203|0.532|
73807729|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.662|||||TWO_SIDED|95.0|0.442|0.992||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.992|0.442|
73807730|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.714|||||TWO_SIDED|95.0|1.142|2.572||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.572|1.142|
73807731|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|Geometric mean ratio at day 22|2.589|||||TWO_SIDED|95.0|1.723|3.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.889|1.723|
73807732|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|4.975|||||TWO_SIDED|95.0|3.757|6.589||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.589|3.757|
73807733|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.168|||||TWO_SIDED|95.0|0.881|1.547||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.547|0.881|
73807734|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.88|||||TWO_SIDED|95.0|0.665|1.166||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.166|0.665|
73807735|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.219|||||TWO_SIDED|95.0|2.43|4.264||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.264|2.430|
73895827|NCT00535288|147325082|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.7|||<|0.01|TWO_SIDED|95.0|-2.7|-0.7||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.7|-2.7|<0.01
73807736|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.07|||||TWO_SIDED|95.0|0.808|1.417||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.417|0.808|
73807737|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.72|||||TWO_SIDED|95.0|0.544|0.954||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.954|0.544|
73807738|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.509|||||TWO_SIDED|95.0|1.891|3.33||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.330|1.891|
73807739|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.235|||||TWO_SIDED|95.0|0.178|0.31||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.310|0.178|
73807740|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.177|||||TWO_SIDED|95.0|0.134|0.234||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.234|0.134|
73807741|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.647|||||TWO_SIDED|95.0|0.489|0.856||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.856|0.489|
73807742|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.215|||||TWO_SIDED|95.0|0.163|0.284||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.284|0.163|
73807743|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.145||||||95.0|0.109|0.191||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.191|0.109|
73807744|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.504|||||TWO_SIDED|95.0|0.381|0.668||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.668|0.381|
73807745|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||TWO_SIDED|95.0|0.57|0.997||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.997|0.570|
73895828|NCT00535288|147325082|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.4|||<|0.01|TWO_SIDED|95.0|-2.4|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.4|-2.4|<0.01
73807746|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.756|||||TWO_SIDED|95.0|2.083|3.647||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.647|2.083|
73807747|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.916|||||TWO_SIDED|95.0|0.694|1.211||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.211|0.694|
73807748|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.616|||||TWO_SIDED|95.0|0.466|1.815||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.815|0.466|
73807749|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.149|||||TWO_SIDED|95.0|1.624|2.843||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.843|1.624|
73807750|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.656|||||TWO_SIDED|95.0|2.764|4.836||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.836|2.764|
73807751|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.216|||||TWO_SIDED|95.0|0.92|1.606||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.606|0.920|
73807752|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.818|||||TWO_SIDED|95.0|0.619|1.081||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.081|0.619|
73807753|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.85|||||TWO_SIDED|95.0|2.152|3.773||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.773|2.152|
73807754|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.332|||||TWO_SIDED|95.0|0.251|0.44||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.440|0.251|
73807755|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.224|||||TWO_SIDED|95.0|0.169|0.296||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.296|0.169|
73895829|NCT00535288|147325082|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.9|-2.9|<0.01
73807756|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.78|||||TWO_SIDED|95.0|0.588|1.003||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.003|0.588|
73807757|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.673|||||TWO_SIDED|95.0|0.509|0.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.889|0.509|
73807758|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.345|||||TWO_SIDED|95.0|1.772|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.102|1.772|
73895830|NCT00535288|147325083|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07|||<|0.01|TWO_SIDED|95.0|-0.12|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.12|<0.01
73895831|NCT00535288|147325083|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.06||||0.02|TWO_SIDED|95.0|-0.11|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.11|0.02
73895832|NCT00535288|147325083|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07|||<|0.01|TWO_SIDED|95.0|-0.13|-0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.02|-0.13|<0.01
73895833|NCT00535288|147325083|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.08|||<|0.01|TWO_SIDED|95.0|-0.14|-0.03||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.03|-0.14|<0.01
73807759|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.485|||||TWO_SIDED|95.0|2.633|4.614||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.614|2.633|
73807760|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.624|||||TWO_SIDED|95.0|1.817|3.789||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.789|1.817|
73807761|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.096|||||TWO_SIDED|95.0|0.76|1.58||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.580|0.760|
73895834|NCT00535288|147325084|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.0||||0.08|TWO_SIDED|95.0|-2.1|0.1||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||0.1|-2.1|0.08
73895835|NCT00535288|147325084|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.6|||<|0.01|TWO_SIDED|95.0|-2.7|-0.5||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.5|-2.7|<0.01
73895836|NCT00535288|147325084|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.5|||<|0.01|TWO_SIDED|95.0|-2.7|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.4|-2.7|<0.01
73895837|NCT00535288|147325084|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.0|||<|0.01|TWO_SIDED|95.0|-3.1|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.9|-3.1|<0.01
73895838|NCT00535288|147325087|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.06||||0.07|TWO_SIDED|95.0|-0.12|0.0||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.00|-0.12|0.07
73807762|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.888|||||TWO_SIDED|95.0|0.615|1.282||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.282|0.615|
73807763|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.12|||||TWO_SIDED|95.0|1.473|3.052||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.052|1.473|
73807764|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.876|||||TWO_SIDED|95.0|0.61|1.26||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.260|0.610|
73807765|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric mean ratio at day 202|0.898|||||TWO_SIDED|95.0|0.622|1.298||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.298|0.622|
73807766|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.451|||||TWO_SIDED|95.0|1.0|2.105||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.105|1.000|
73807767|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.418|||||TWO_SIDED|95.0|0.289|0.603||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.603|0.289|
73807768|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.338|||||TWO_SIDED|95.0|0.235|0.487||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.487|0.235|
73807769|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.808|||||TWO_SIDED|95.0|0.561|1.165||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.165|0.561|
73807770|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.334|||||TWO_SIDED|95.0|0.233|0.479||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.479|0.233|
73895839|NCT00535288|147325087|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.05||||0.24|TWO_SIDED|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.02|-0.11|0.24
73895840|NCT00535288|147325087|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.04||||0.29|TWO_SIDED|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.02|-0.11|0.29
73895841|NCT00535288|147325087|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07||||0.02|TWO_SIDED|95.0|-0.14|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.14|0.02
73895842|NCT01129583|147325099|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
73807771|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.342|||||TWO_SIDED|95.0|0.237|0.494||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.494|0.237|
73807772|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.553|||||TWO_SIDED|95.0|0.382|0.801||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.801|0.382|
73807773|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.811|||||TWO_SIDED|95.0|0.562|1.169||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.169|0.562|
73807774|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.935|||||TWO_SIDED|95.0|1.347|2.78||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.780|1.347|
73807775|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.8|||||TWO_SIDED|95.0|0.558|1.147||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.147|0.558|
73807776|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.82|||||TWO_SIDED|95.0|0.568|1.184||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.184|0.568|
73807777|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.324|||||TWO_SIDED|95.0|0.915|1.917||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.917|0.915|
73807778|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.388|||||TWO_SIDED|95.0|1.658|3.438||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.438|1.658|
73807779|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.987|||||TWO_SIDED|95.0|0.688|1.416||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.416|0.688|
73807780|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.012|||||TWO_SIDED|95.0|0.701|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.460|0.701|
73895843|NCT01129583|147325100|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
73895844|NCT01129583|147325101|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
73895845|NCT02600871|147325102|SUPERIORITY|The significance of variation in proportions with treatment (Provodine®, Control) was assessed with Fisher's Exact tests and variation in the mean with treatment was assessed with T-tests.||||||0.71|||||||Fisher Exact|||||||0.71
73807781|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.634|||||TWO_SIDED|95.0|1.128|2.366||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.366|1.128|
73807782|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.413|||||TWO_SIDED|95.0|0.288|0.592||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.592|0.288|
73807783|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.424|||||TWO_SIDED|95.0|0.294|0.61||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.610|0.294|
73807784|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.684|||||TWO_SIDED|95.0|0.473|0.99||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.990|0.473|
73807785|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.025|||||TWO_SIDED|95.0|0.714|1.473||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.473|0.714|
73807786|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.656|||||TWO_SIDED|95.0|1.15|2.385||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.385|1.150|
73807787|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.615|||||TWO_SIDED|95.0|1.115|2.339||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.339|1.115|
73807788|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.906|||||TWO_SIDED|95.0|1.177|3.087||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.087|1.177|
73807789|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.945|||||TWO_SIDED|95.0|0.583|1.533||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.533|0.583|
73895846|NCT04672954|147325105|OTHER||Ratio|1.29||||0.3941|TWO_SIDED|90.0|0.78|2.13|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.34|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.13|0.78|0.3941
73807790|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.763|||||TWO_SIDED|95.0|0.468|1.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.245|0.468|
73807791|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.818|||||TWO_SIDED|95.0|1.119|2.956||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.956|1.119|
73807792|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.917|||||TWO_SIDED|95.0|0.568|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.481|0.568|
73807793|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.855|||||TWO_SIDED|95.0|0.524|1.396||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.396|0.524|
73807794|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.203|||||TWO_SIDED|95.0|0.745|1.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.943|0.745|
73807795|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.496|||||TWO_SIDED|95.0|0.31|0.794||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.794|0.310|
73807796|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.4|||||TWO_SIDED|95.0|0.25|0.641||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.641|0.250|
73807797|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.954|||||TWO_SIDED|95.0|0.596|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.528|0.596|
73807798|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.481|||||TWO_SIDED|95.0|0.306|0.758||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.758|0.306|
73807799|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.449|||||TWO_SIDED|95.0|0.279|0.722||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.722|0.279|
73807800|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.631|||||TWO_SIDED|95.0|0.398|1.002||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.002|0.398|
73895847|NCT04672954|147325105|OTHER||Ratio|1.66||||0.1089|TWO_SIDED|90.0|0.99|2.79|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.35|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.79|0.99|0.1089
73807801|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.807|||||TWO_SIDED|95.0|0.5|1.304||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.304|0.500|
73807802|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.924|||||TWO_SIDED|95.0|1.193|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.102|1.193|
73807803|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.97|||||TWO_SIDED|95.0|0.611|1.541||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.541|0.611|
73807804|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.905|||||TWO_SIDED|95.0|0.561|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.460|0.561|
73807805|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.273|||||TWO_SIDED|95.0|0.798|2.03||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.030|0.798|
73807806|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|2.383|||||TWO_SIDED|95.0|1.474|3.851||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.851|1.474|
73807807|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.202|||||TWO_SIDED|95.0|0.754|1.915||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.915|0.754|
73807808|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.12|||||TWO_SIDED|95.0|0.689|1.821||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.821|0.689|
73807809|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.576|||||TWO_SIDED|95.0|0.987|2.516||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.516|0.987|
73807810|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.504|||||TWO_SIDED|95.0|0.316|0.805||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.805|0.316|
73895848|NCT04672954|147325105|OTHER||Ratio|1.14||||0.6308|TWO_SIDED|90.0|0.71|1.85|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.32|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||1.85|0.71|0.6308
73807811|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.47|||||TWO_SIDED|95.0|0.293|0.754||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.754|0.293|
73807812|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.662|||||TWO_SIDED|95.0|0.414|1.056||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.056|0.414|
73807813|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.932|||||TWO_SIDED|95.0|0.583|1.492||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.492|0.583|
73807814|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.312|||||TWO_SIDED|95.0|0.831|2.071||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.071|0.831|
73807815|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.407|||||TWO_SIDED|95.0|0.88|2.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.249|0.880|
73807816|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|5.428|||||TWO_SIDED|95.0|4.0|7.365||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||7.365|4|
73807817|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.091|||||TWO_SIDED|95.0|0.804|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.481|0.804|
73807818|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.759|||||TWO_SIDED|95.0|0.559|1.031||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.031|0.559|
73807819|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.499|||||TWO_SIDED|95.0|2.577|4.751||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.751|2.577|
73807820|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.982|||||TWO_SIDED|95.0|0.722|1.334||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.334|0.722|
73895849|NCT04672954|147325105|OTHER||Ratio|1.75||||0.069|TWO_SIDED|90.0|1.06|2.89|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.33|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.89|1.06|0.0690
73807821|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.699|||||TWO_SIDED|95.0|0.513|0.95||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.95|0.513|
73807822|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.513|||||TWO_SIDED|95.0|1.846|3.421||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.421|1.846|
73807823|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.201|||||TWO_SIDED|95.0|0.149|0.272||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.272|0.149|
73807824|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.14|||||TWO_SIDED|95.0|0.103|0.189||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.189|0.103|
73807825|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.645|||||TWO_SIDED|95.0|0.476|0.873||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.873|0.476|
73807826|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.181|||||TWO_SIDED|95.0|0.134|0.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.245|0.134|
73807827|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.129|||||TWO_SIDED|95.0|0.095|0.174||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.174|0.095|
73807828|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric Mean Ratio at day 29|0.463|||||TWO_SIDED|95.0|0.341|0.628||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.628|0.341|
73807829|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.696|||||TWO_SIDED|95.0|0.514|0.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.943|0.514|
73807830|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.207|||||TWO_SIDED|95.0|2.368|4.343||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.343|2.368|
73895850|NCT04093024|147325196|OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9858|TWO_SIDED|95.0|-0.8|0.8|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||0.8|-0.8|0.9858
73807831|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.9|||||TWO_SIDED|95.0|0.665|1.218||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.218|0.665|
73807832|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.64|||||TWO_SIDED|95.0|0.472|0.868||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.868|0.472|
73807833|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.303|||||TWO_SIDED|95.0|1.7|3.121||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.121|1.7|
73807834|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|4.608|||||TWO_SIDED|95.0|3.398|6.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.249|3.398|
73807835|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.293|||||TWO_SIDED|95.0|0.954|1.753||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.753|0.954|
73807836|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.92|||||TWO_SIDED|95.0|0.677|1.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.249|0.677|
73807837|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.31|||||TWO_SIDED|95.0|2.436|4.496||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.496|2.436|
73807838|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.281|||||TWO_SIDED|95.0|0.207|0.38||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.38|0.207|
73807839|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.2|||||TWO_SIDED|95.0|0.147|0.271||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.271|0.147|
73807840|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.718|||||TWO_SIDED|95.0|0.529|0.975||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.975|0.529|
73895851|NCT04093024|147325197|OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9769|TWO_SIDED|95.0|-1.7|1.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||1.6|-1.7|0.9769
73807841|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.712|||||TWO_SIDED|95.0|0.524|0.966||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.966|0.524|
73807842|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.56|||||TWO_SIDED|95.0|1.886|3.474||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.474|1.886|
73807843|NCT00972816|147165193|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.597|||||TWO_SIDED|95.0|2.646|4.89||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.89|2.646|
73807844|NCT01767506|147165201|SUPERIORITY||Odds Ratio (OR)|2.6|||>|0.05|TWO_SIDED|95.0|0.56|11.9|||Regression, Logistic||||The null hypothesis was that we could further decrease infection to 1% or less in more of the communities in the surveillance intervention arm, compared to control communities.|11.9|0.56|>0.05
73807845|NCT01767506|147165202|SUPERIORITY||Mean Difference (Final Values)|3.9||||1|TWO_SIDED||||||Fisher Exact|||||||1
73807846|NCT03854370|147165204|SUPERIORITY|||||||0.23|||||||Chi-squared|||Comparison of all four groups prior to surgical scrub.||||0.23
73807847|NCT03854370|147165204|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||0.31
73807848|NCT03854370|147165204|SUPERIORITY|||||||0.35|||||||Fisher Exact|||Comparison of Chlorhexidine versus iodine post surgical scrub||||.35
73807849|NCT03854370|147165204|SUPERIORITY|||||||0.61|||||||Fisher Exact|||Comparison of chloroxynel versus iodine post surgical scrub||||.61
73807850|NCT03854370|147165205|SUPERIORITY|||||||0.59|||||||Chi-squared|||comparison of all four groups prior to surgical scrub||||.59
73807851|NCT03854370|147165205|SUPERIORITY|||||||0.05|||||||Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||.05
73807852|NCT03854370|147165205|SUPERIORITY|||||||0.13|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine post surgical scrub||||.13
73807853|NCT03854370|147165205|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post surgical scrub||||0.99
73807854|NCT03854370|147165206|SUPERIORITY|||||||0.45|||||||Chi-squared|||Comparison of all four groups prior to surgical scrub||||0.45
73807855|NCT03854370|147165206|SUPERIORITY|||||||0.99||||||all groups were negative for cultures|Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||0.99
73807856|NCT03854370|147165206|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chlorhexidine versus iodine at post surgical scrub||||0.99
73807857|NCT03854370|147165206|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chloroxynel versus iodine at post surgical scrub||||0.99
73807858|NCT03854370|147165207|SUPERIORITY|||||||0.61|||||||Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.61
73807859|NCT03854370|147165207|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine at post procedure||||0.99
73807860|NCT03854370|147165207|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.99
73807861|NCT03854370|147165208|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.32
73807862|NCT03854370|147165208|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine at post procedure||||0.99
73807863|NCT03854370|147165208|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.50
73807864|NCT03854370|147165209|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.99
73807865|NCT03854370|147165209|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||comparison of chlorhexidine versus iodine at post procedure||||0.99
73807866|NCT03854370|147165209|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.99
73807867|NCT01608087|147165242|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|96.58|||||TWO_SIDED|93.93|88.54|105.35|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|105.35|88.54|
73807868|NCT01608087|147165242|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.68|||||TWO_SIDED|93.93|83.5|100.65|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.65|83.50|
73807869|NCT01608087|147165242|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|94.92|||||TWO_SIDED|93.93|87.14|103.4|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|103.40|87.14|
73807870|NCT01608087|147165243|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|98.96|||||TWO_SIDED|90.0|90.97|107.64|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|107.64|90.97|
73807871|NCT01608087|147165243|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.67|||||TWO_SIDED|90.0|84.02|100.01|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.01|84.02|
73807872|NCT01608087|147165243|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|92.63|||||TWO_SIDED|90.0|85.18|100.74|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.74|85.18|
73807873|NCT01608087|147165244|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|101.53|||||TWO_SIDED|90.0|92.74|111.14|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|111.14|92.74|
73807874|NCT01608087|147165244|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|93.25|||||TWO_SIDED|90.0|87.12|99.81|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|99.81|87.12|
73807875|NCT01608087|147165244|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.85|||||TWO_SIDED|90.0|83.91|100.54|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least square estimates of log-transformed PK endpoint for R1 and R2 were back transformed to original scale to get adjusted point estimator and interval estimates for the inter-subject ratio of the geometric means for treatments.|100.54|83.91|
73807876|NCT02821338|147165257|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference ratio|0.9863|||||TWO_SIDED|90.0|0.9598|1.0134||||||90% confidence interval of the geometric mean ratio of test/reference||1.0134|0.9598|
73807877|NCT02821338|147165258|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|0.9785|||||TWO_SIDED|90.0|0.9484|1.0095||||||||1.0095|0.9484|
73807878|NCT02821338|147165259|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|1.047|||||TWO_SIDED|90.0|1.0079|1.0877||||||||1.0877|1.0079|
73807879|NCT00712881|147165298|OTHER|||||||0.154||||||Threshold for significance at 0.05 level.|2-sided, binomial proportions|||||||0.154
73807880|NCT01194999|147165307|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No significant difference from baseline to final follow-up.||||0.001
73807881|NCT01011465|147165308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.03||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.03
73807882|NCT01011465|147165308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.89||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.89
73807883|NCT01011465|147165308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.52||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.52
73807884|NCT01011465|147165309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.43||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.43
73807885|NCT01011465|147165309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.08||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.08
73807886|NCT01011465|147165309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.25||95.0|||||ANOVA|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.25
73807887|NCT01011465|147165310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.83||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.83
73807888|NCT01011465|147165310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.56||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.56
73807889|NCT01011465|147165310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.95||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.95
73807890|NCT00823043|147165357|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<.001
73807891|NCT00823043|147165358|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||||||0.024
73807892|NCT00823043|147165359|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||t-test, 2 sided|||||||0.75
73807893|NCT00823043|147165360|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 2 sided|||||||0.69
73807894|NCT04259424|147165361|OTHER|||||||0.15|||||||t-test, 2 sided|||||||.15
73807895|NCT03702010|147165404|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||Baseline VAS||||0.112
73807896|NCT03702010|147165404|SUPERIORITY|||||||0.323|||||||t-test, 2 sided|||After first stimulation VAS||||0.323
73807897|NCT03702010|147165404|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||After second stimulation||||0.760
73807898|NCT03702010|147165404|SUPERIORITY|||||||0.624|||||||t-test, 2 sided|||End of Follow-up||||0.624
73807899|NCT03702010|147165405|SUPERIORITY|||||||0.589|||||||t-test, 2 sided|||After first stimulation||||0.589
73807900|NCT03702010|147165405|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||After second stimulation||||0.704
73807901|NCT03702010|147165405|SUPERIORITY|||||||0.908|||||||t-test, 2 sided|||End of Follow-up||||0.908
73807902|NCT03702010|147165406|SUPERIORITY|||||||0.231|||||||t-test, 2 sided|||Baseline||||0.231
73807903|NCT03702010|147165406|SUPERIORITY|||||||0.663|||||||t-test, 2 sided|||After first stimulation||||0.663
73807904|NCT03702010|147165406|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||After second stimulation||||0.998
73807905|NCT03702010|147165406|SUPERIORITY|||||||0.713|||||||t-test, 2 sided|||End of Follow-up||||0.713
73807906|NCT03557931|147165409|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.02||0.858|TWO_SIDED|90.0|-1.51|1.88|||MMRM Method|||Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (least square (LS) Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment\*visit, and visit\*baseline as fixed effects, and baseline as a covariate.|Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 50 mg vs placebo) \* sqrt(1/n\[PLACEBO\] + 1/n\[ASP4345\]). The Cohen's d Effect Size value for ASP4345 50 mg vs placebo is 0.035.|1.88|-1.51|0.858
73807907|NCT03557931|147165409|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-1.93|1.36|||0.775|||MMRM analysis model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment\*visit, and visit\*baseline as fixed effects, and baseline as a covariate.|Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 150 mg vs placebo) \* sqrt(1/n\[PLACEBO\] + 1/n\[ASP4345\]). The Cohen's d Effect Size value for ASP4345 150 mg vs placebo is - 0.053.|1.36|-1.93|
73807908|NCT03557931|147165415|SUPERIORITY||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|1.6||0.639|TWO_SIDED|90.0|-1.9|3.41|||ANCOVA|||Analysis of covariance (ANCOVA) model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.||3.41|-1.90|0.639
73895852|NCT04093024|147325199|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.4||0.4442|TWO_SIDED|95.0|-1.8|4.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||4.0|-1.8|0.4442
73807909|NCT03557931|147165415|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|1.54||0.721|TWO_SIDED|90.0|-3.11|2.01|||ANCOVA|||ANCOVA model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.||2.01|-3.11|0.721
73807910|NCT02989649|147165467|OTHER||Least Square Mean (LSM)|-1.25|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-1.44|-1.05|||Regression, Linear||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-1.05|-1.44|<0.001
73807911|NCT02989649|147165468|OTHER|||||||0.423|||||||Regression, Linear|||Statistical analysis for subgroup: Prior therapy of diabetes mellitus, Ever used or Never used||||0.423
73807912|NCT02989649|147165468|OTHER|||||||0.747|||||||Regression, Linear|||Statistical analysis for subgroup: Sex, Male or Female||||0.747
73807913|NCT02989649|147165468|OTHER||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Age, \<45 or \>=45 to \<65 years or \>=65 years||||<0.001
73807914|NCT02989649|147165468|OTHER|||||||0.99|||||||Regression, Linear|||Statistical analysis for subgroup: Cardiovascular risk group, Yes or No||||0.990
73807915|NCT02989649|147165468|OTHER|||||||0.841|||||||Regression, Linear|||Statistical analysis for subgroup: Therapy type, Monotherapy or Combined therapy||||0.841
73807916|NCT02989649|147165468|OTHER|||||||0.847|||||||Regression, Linear|||Statistical analysis for subgroup: Baseline BMI, \<25 or 25 to \<30 or \>=30 kg/m\^2||||0.847
73807917|NCT02989649|147165468|OTHER||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Initial glycemic control, \<7% or \>=7%||||<0.001
73807918|NCT02989649|147165471|OTHER||Least Square Mean (LSM)|-0.95|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-1.29|-0.62|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3||-0.62|-1.29|
73895853|NCT04093024|147325202|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.8||0.882|TWO_SIDED|95.0|-1.5|1.8|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||1.8|-1.5|0.8820
73807919|NCT02989649|147165471|OTHER||Least Square Mean (LSM)|-0.87|STANDARD_ERROR_OF_MEAN|0.245|||TWO_SIDED|95.0|-1.36|-0.39|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-0.39|-1.36|
73807920|NCT02989649|147165472|OTHER||Least Square Mean (LSM)|-0.95|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-1.18|-0.72|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3||-0.72|-1.18|
73807921|NCT02989649|147165472|OTHER||Least Square Mean|-1.25|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|95.0|-1.44|-1.05|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-1.05|-1.44|
73807922|NCT02004886|147165476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.9|||<|0.001|TWO_SIDED|95.0|-38.4|-13.3|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-13.3|-38.4|<0.001
73807923|NCT02004886|147165476|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-53.6|||<|0.001|TWO_SIDED|95.0|-66.1|-41.1|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-41.1|-66.1|<0.001
73807924|NCT02004886|147165476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0|||<|0.001|TWO_SIDED|95.0|-38.4|-13.6|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-13.6|-38.4|<0.001
73807925|NCT02004886|147165479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3||||0.04|TWO_SIDED|95.0|-35.7|-0.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-0.9|-35.7|0.04
73807926|NCT02004886|147165479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.6|||<|0.001|TWO_SIDED|95.0|-60.9|-26.3|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-26.3|-60.9|<0.001
73807927|NCT02004886|147165479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.32|TWO_SIDED|95.0|-25.7|8.5|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||8.5|-25.7|0.320
73807928|NCT02004886|147165481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.751|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||||0.9|-0.7|0.751
73807929|NCT02004886|147165481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.581|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|||||0.6|-1.0|0.581
73807930|NCT02004886|147165481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.918|TWO_SIDED|95.0|-0.8|0.8|||ANCOVA|||||0.8|-0.8|0.918
73807931|NCT02004886|147165483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.253|TWO_SIDED|95.0|-21.1|5.6|||ANCOVA|||||5.6|-21.1|0.253
73807932|NCT02004886|147165483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5||||0.07|TWO_SIDED|95.0|-26.0|1.0|||ANCOVA|||||1.0|-26.0|0.070
73807933|NCT02004886|147165483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.1|||<|0.001|TWO_SIDED|95.0|-39.5|-12.8|||ANCOVA|||||-12.8|-39.5|<0.001
73807934|NCT02004886|147165484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-89.9||||0.002|TWO_SIDED|95.0|-145.6|-34.0|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-34.0|-145.6|0.002
73807935|NCT02004886|147165484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-191.1|||<|0.001|TWO_SIDED|95.0|-246.4|-135.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-135.9|-246.4|<0.001
73807936|NCT02004886|147165484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-97.7||||0.001|TWO_SIDED|95.0|-152.4|-42.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-42.9|-152.4|0.001
73807937|NCT02004886|147165485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.408|TWO_SIDED|95.0|-1.5|3.7|||ANCOVA|||||3.7|-1.5|0.408
73807938|NCT02004886|147165485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.741|TWO_SIDED|95.0|-3.1|2.2|||ANCOVA|||||2.2|-3.1|0.741
73807939|NCT02004886|147165485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.906|TWO_SIDED|95.0|-2.8|2.5|||ANCOVA|||||2.5|-2.8|0.906
73807940|NCT02004886|147165486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.857|TWO_SIDED|95.0|-30.4|25.3|||ANCOVA|||||25.3|-30.4|0.857
73807941|NCT02004886|147165486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.906|TWO_SIDED|95.0|-30.3|26.9|||ANCOVA|||||26.9|-30.3|0.906
73807942|NCT02004886|147165486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.63|TWO_SIDED|95.0|-34.0|20.8|||ANCOVA|||||20.8|-34.0|0.630
73807943|NCT01876784|147165490|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.08|TWO_SIDED|95.0|0.55|1.03||Threshold for significance at 0.05 level.|Log Rank||Vandetanib 300 mg vs Placebo|A multiple testing procedure (MTP) with an alpha-exhaustive recycling strategy was employed to provide adequate control of type I error.||1.03|0.55|0.080
73807944|NCT03605862|147165497|SUPERIORITY|||||||0.4009|||||||Gehan-Wilcoxon|Analysis was stratified by time from onset of symptoms, pre-enrollment symptom relief medication use, and presence of underlying lung conditions||||||0.4009
73807945|NCT03605862|147165498|SUPERIORITY|||||||0.1923|||||||Gehan-Wilcoxon|Analysis was stratified by time from onset of symptoms, pre-enrollment symptom relief medication use, and presence of underlying lung conditions||||||0.1923
73807946|NCT03605862|147165499|SUPERIORITY|||||||0.2057|||||||Fisher Exact|||||||0.2057
73807947|NCT03605862|147165500|SUPERIORITY|||||||0.0712|||||||Gehan-Wilcoxon|Analysis stratified by time from symptom onset at Baseline, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0712
73807948|NCT03605862|147165501|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison for study day 2||||1.0000
73807949|NCT03605862|147165501|SUPERIORITY|||||||0.9142|||||||Fisher Exact|||Comparison for study day 3||||0.9142
73807950|NCT03605862|147165501|SUPERIORITY|||||||0.0132|||||||Fisher Exact|||Comparison for study day 7||||0.0132
73807951|NCT03605862|147165502|SUPERIORITY|||||||0.1239|||||||t-test, 2 sided|||Comparison for day 2||||0.1239
73807952|NCT03605862|147165502|SUPERIORITY|||||||0.1022|||||||t-test, 2 sided|||Comparison for day 3||||0.1022
73807953|NCT03605862|147165502|SUPERIORITY|||||||0.46213|||||||t-test, 2 sided|||Comparison for day 7||||0.46213
73807954|NCT03605862|147165505|SUPERIORITY|||||||0.014|||||||Gehan-Wilcoxon|Analysis stratified by time from symptom onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0140
73807955|NCT03605862|147165506|SUPERIORITY|||||||0.0112|||||||Gehan-Wilcoxon|Analysis stratified by time from onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0112
73807956|NCT03605862|147165507|SUPERIORITY||||||<|0.0001|||||||Gehan-Wilcoxon|Analysis stratified by time from onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||<0.0001
73807957|NCT05239494|147165511|SUPERIORITY||Median Difference (Final Values)|0.001|||<|0.001|TWO_SIDED||||||Shapiro-Wilks|||This study used a ±50 VAS scale, with values in the positive and negative range indicating that the contact lenses were comfortable or uncomfortable, respectively. A score of zero on this scale indicated neutral CL comfort.||||<0.001
73807958|NCT00977314|147165533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|1.0|<|0.001|||||||t-test, 2 sided|||The endpoint was the calculated difference between the HINT result for the unaided condition prior to the 30-day trial period (Day 1) and the HINT result using the SoundBite (aided) at the end of the 30-day trial period (Day 30).||||<0.001
73807959|NCT02235077|147165574|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5688|TWO_SIDED|95.0|-0.11|0.2|||Regression, Linear|||||0.20|-0.11|0.5688
73807960|NCT02235077|147165575|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.4155|TWO_SIDED|95.0|-0.35|0.86|||Regression, Linear|||||0.86|-0.35|0.4155
73807961|NCT02235077|147165576|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3039|TWO_SIDED|95.0|0.83|1.81|||Chi-squared|||||1.81|0.83|0.3039
73807962|NCT02235077|147165577|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.7673|TWO_SIDED|95.0|-0.09|0.07|||Regression, Linear|||||0.07|-0.09|0.7673
73807963|NCT02235077|147165578|SUPERIORITY||Mean Difference (Final Values)|319.2||||0.5734|TWO_SIDED|95.0|-797.4|1435.8|||Regression, Linear|||||1435.8|-797.4|0.5734
73807964|NCT02235077|147165579|SUPERIORITY||Mean Difference (Final Values)|-1.02||||0.3528|TWO_SIDED|95.0|-3.05|1.01|||Regression, Linear|||||1.01|-3.05|0.3528
73807965|NCT02235077|147165580|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.0846|TWO_SIDED|95.0|-0.02|0.25|||Regression, Linear|||||0.25|-0.02|0.0846
73807966|NCT02235077|147165581|SUPERIORITY||Mean Difference (Final Values)|-12.17||||0.0842|TWO_SIDED|95.0|-25.98|1.65|||Regression, Linear|||||1.65|-25.98|0.0842
73807967|NCT02235077|147165582|SUPERIORITY||Odds Ratio (OR)|1.11||||0.7628|TWO_SIDED|95.0|0.56|2.23|||Regression, Logistic|||||2.23|0.56|0.7628
73807968|NCT02235077|147165583|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.6102|TWO_SIDED|95.0|-5.02|2.95|||Regression, Linear|||||2.95|-5.02|0.6102
73807969|NCT02235077|147165584|SUPERIORITY||Odds Ratio (OR)|0.76||||0.5818|TWO_SIDED|95.0|0.29|1.99|||Regression, Logistic|||||1.99|0.29|0.5818
73807970|NCT03852628|147165585|SUPERIORITY||Odds Ratio (OR)|0.17||||0.08|TWO_SIDED|95.0|0.02|1.22|||Mixed Models Analysis|Modeled the probability of having a reduction in AUD||The Placebo arm served as the reference group.||1.22|0.02|0.08
73895854|NCT04093024|147325203|OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.6||0.9652|TWO_SIDED|95.0|-3.2|3.3|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||3.3|-3.2|0.9652
73807971|NCT03852628|147165586|SUPERIORITY||Odds Ratio (OR)|0.76||||0.69|TWO_SIDED|95.0|0.2|2.97|||Mixed Models Analysis|Modeled the probability of reduction in PTSD symptom.||The placebo arm served as the reference group.||2.97|0.20|0.690
73895855|NCT04093024|147325204|OTHER||Adjusted mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1||0.4084|TWO_SIDED|95.0|-9.3|4.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||4.0|-9.3|0.4084
73807972|NCT03852628|147165587|SUPERIORITY||Odds Ratio (OR)|0.63||||0.52|TWO_SIDED|95.0|0.15|2.66|||Mixed Models Analysis|Modeled the probability of have both a reduction in PTSD and AUD||The Placebo arm served as the reference group.||2.66|0.15|0.52
73807973|NCT00586820|147165589|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
73807974|NCT00586820|147165590|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 8 hours post PCI.||||0.019
73807975|NCT00586820|147165590|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 16 hours post-PCI.||||0.007
73807976|NCT02778074|147165647|SUPERIORITY||Mean Difference (Final Values)|-2.34|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
73807977|NCT01817582|147165657|OTHER||Least square (LS) mean difference|0.3||||0.6199|TWO_SIDED|95.0|-0.7|1.3||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||1.3|-0.7|0.6199
73807978|NCT01817582|147165657|OTHER||LS mean difference|0.1||||0.807|TWO_SIDED|95.0|-0.9|1.2||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||1.2|-0.9|0.8070
73807979|NCT01817582|147165657|OTHER||LS mean difference|-0.1||||0.8068|TWO_SIDED|95.0|-1.1|0.9||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||0.9|-1.1|0.8068
73807980|NCT01817582|147165658|OTHER||LS mean difference|-4.4||||0.2296|TWO_SIDED|95.0|-11.6|2.8||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||2.8|-11.6|0.2296
73807981|NCT01817582|147165658|OTHER||LS mean difference|-4.9||||0.189|TWO_SIDED|95.0|-12.3|2.5||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||2.5|-12.3|0.1890
73807982|NCT01817582|147165658|OTHER||LS mean difference|-0.5||||0.8836|TWO_SIDED|95.0|-7.7|6.7||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||6.7|-7.7|0.8836
73807983|NCT02122887|147165683|OTHER|χ² (1) =4.57, Cramer's V=.24|||||<|0.05|||||||Chi-squared|||we hypothesised that following intervention, those undergoing intervention will be more likely to see justice on both sides, compared to control group||||<0.05
73807984|NCT02122887|147165684|EQUIVALENCE|we compared participants levels of tension (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.65|||>|0.05|TWO_SIDED|95.0|||||ANOVA|df=1||||||>0.05
73807985|NCT02122887|147165685|EQUIVALENCE|we compared participants levels of empathy (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.04|||>|0.05|TWO_SIDED|95.0|||||ANOVA|||||||>0.05
73807986|NCT01585324|147165717|SUPERIORITY_OR_OTHER|||||||0.8333|TWO_SIDED||||||ANCOVA|The analysis of covariance (ANCOVA) test for the efficacy of SVR achievement (Yes/No), treatment adjustment and baseline hemoglobin value was used.||||||0.8333
73807987|NCT01585324|147165719|SUPERIORITY_OR_OTHER|||||||0.0867|TWO_SIDED||||||Fisher Exact|||||||0.0867
73807988|NCT01585324|147165721|SUPERIORITY_OR_OTHER|||||||0.6492|TWO_SIDED||||||ANCOVA|||||||0.6492
73807989|NCT01585324|147165723|SUPERIORITY_OR_OTHER|||||||0.0333|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0333
73807990|NCT03917472|147165736|SUPERIORITY|(1-sided)|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.89||0.099|TWO_SIDED|95.0|-0.6|2.9|||ANOVA|||||2.9|-0.6|0.099
73807991|NCT03917472|147165736|NON_INFERIORITY|(4-letter margin) (1-sided)|||||<|0.001|||||||ANOVA|||||||<0.001
73807992|NCT03917472|147165737|SUPERIORITY|(1-sided); Week 52|LS mean difference|-41.4|STANDARD_ERROR_OF_MEAN|8.94|<|0.001|TWO_SIDED|95.0|-58.9|-23.8|||ANOVA|||||-23.8|-58.9|<0.001
73807993|NCT03917472|147165738|SUPERIORITY|(1-sided) Week 52|Difference - %|20.0|||<|0.001|TWO_SIDED|95.0|12.5|28.6|||Clopper-Pearson exact method.|||||28.6|12.5|<0.001
73807994|NCT03917472|147165745|OTHER|Descriptive|Difference - %|9.3|||||TWO_SIDED|95.0|1.7|17.0|||Clopper-Pearson exact method|||≥ 5 letters gain from baseline or BCVA ≥ 84 letters at Week 52||17.0|1.7|
73807995|NCT03917472|147165745|OTHER|Descriptive|Difference - %|7.7|||||TWO_SIDED|95.0|-1.5|17.0|||Clopper-Pearson exact method|||≥ 10 letters gain from baseline or BCVA ≥ 84 letters at Week 52||17.0|-1.5|
73807996|NCT03917472|147165745|OTHER|Descriptive|Difference - %|5.5|||||TWO_SIDED|95.0|-2.7|14.3|||Clopper-Pearson exact method|||≥ 15 letters gain from baseline or BCVA ≥ 84 letters at Week 52||14.3|-2.7|
73895856|NCT04093024|147325205|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9928|TWO_SIDED|95.0|-1.6|1.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||1.6|-1.6|0.9928
73895857|NCT04093024|147325206|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6366|TWO_SIDED|95.0|-2.3|3.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||3.6|-2.3|0.6366
73895858|NCT04093024|147325207|OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|2.3||0.8823|TWO_SIDED|95.0|-5.2|5.9|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||5.9|-5.2|0.8823
73895859|NCT04093024|147325208|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.2052|STANDARD_ERROR_OF_MEAN|2.2491||0.5962|TWO_SIDED|95.0|-3.3966|5.807|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.8070|-3.3966|0.5962
73895860|NCT04093024|147325209|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.7733|STANDARD_ERROR_OF_MEAN|3.1424||0.5776|TWO_SIDED|95.0|-4.7015|8.2481|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||8.2481|-4.7015|0.5776
73895861|NCT04093024|147325210|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|-0.134|STANDARD_ERROR_OF_MEAN|4.316||0.9755|TWO_SIDED|95.0|-8.975|8.707|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||8.707|-8.975|0.9755
73895862|NCT04093024|147325211|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|3.453|STANDARD_ERROR_OF_MEAN|5.225||0.514|TWO_SIDED|95.0|-7.25|14.157|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||14.157|-7.250|0.5140
73895863|NCT04093024|147325212|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|3.358||0.7613|TWO_SIDED|95.0|-5.848|7.908|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||7.908|-5.848|0.7613
73895864|NCT04093024|147325213|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|5.049||0.9468|TWO_SIDED|95.0|-10.026|10.707|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||10.707|-10.026|0.9468
73895865|NCT04093024|147325214|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.33||0.0908|TWO_SIDED|95.0|-0.39|5.02|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.02|-0.39|0.0908
73895866|NCT04093024|147325215|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|2.28|STANDARD_ERROR_OF_MEAN|1.39||0.1222|TWO_SIDED|95.0|-0.69|5.25|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.25|-0.69|0.1222
73895867|NCT04093024|147325216|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|7.2|STANDARD_ERROR_OF_MEAN|28.2||0.8012|TWO_SIDED|95.0|-50.7|65.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||65.0|-50.7|0.8012
73895868|NCT04093024|147325217|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|-32.9|STANDARD_ERROR_OF_MEAN|33.8||0.3401|TWO_SIDED|95.0|-103.1|37.2|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||37.2|-103.1|0.3401
73807997|NCT03917472|147165746|OTHER|descriptive; week 12|Difference - %|8.3|||||TWO_SIDED|95.0|0.2|16.5|||Clopper-Pearson exact method|||||16.5|0.2|
73807998|NCT03917472|147165746|OTHER|descriptive; week 24|Difference - %|6.0|||||TWO_SIDED|95.0|-3.0|14.9|||Clopper-Pearson exact method|||||14.9|-3.0|
73807999|NCT03917472|147165746|NON_INFERIORITY|(10% margin); week 52|Difference - %|6.0||||0.002|TWO_SIDED|95.0|-3.9|16.1||(10% margin) (1-sided)|Clopper-Pearson exact method|||||16.1|-3.9|0.002
73808000|NCT03917472|147165747|OTHER|descriptive; week 12|Difference - %|2.0|||||TWO_SIDED|95.0|-2.5|6.6|||Clopper-Pearson exact method|||||6.6|-2.5|
73808001|NCT03917472|147165747|OTHER|descriptive; week 24|Difference - %|2.4|||||TWO_SIDED|95.0|-3.0|7.7|||Clopper-Pearson exact method|||||7.7|-3.0|
73808002|NCT03917472|147165747|OTHER|descriptive; week 52|Difference - %|3.9|||||TWO_SIDED|95.0|-2.0|9.8|||Clopper-Pearson exact method|||||9.8|-2.0|
73808003|NCT01953601|147165761|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.1||||0.6734|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-0.3|0.6734
73808004|NCT01953601|147165761|SUPERIORITY||Difference in Least Squares Means (LSM)|0.4||||0.0141|TWO_SIDED|97.51|0.0|0.8|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.8|0.0|0.0141
73808005|NCT01953601|147165763|OTHER||Difference in % vs Placebo|4.32|||||TWO_SIDED|95.0|0.4|8.31|||||Difference in % = Arm A - Arm C|||8.31|0.40|
73808006|NCT01953601|147165763|OTHER||Difference in % vs Placebo|5.17|||||TWO_SIDED|95.0|1.33|9.09|||||Difference in % = Arm B - Arm C|||9.09|1.33|
73808007|NCT01953601|147165764|OTHER||Difference in % vs Placebo|2.08|||||TWO_SIDED|95.0|-0.84|5.1|||||Difference in % = Arm A - Arm C|||5.10|-0.84|
73808008|NCT01953601|147165764|OTHER||Difference in % vs Placebo|5.58|||||TWO_SIDED|95.0|2.35|8.99|||||Difference in % = Arm B - Arm C|||8.99|2.35|
73808009|NCT01953601|147165765|OTHER||Difference in % vs Placebo|-6.79|||||TWO_SIDED|95.0|-16.16|2.68|||||Difference in % = Arm A - Arm C|||2.68|-16.16|
73808010|NCT01953601|147165765|OTHER||Difference in % vs Placebo|-10.68|||||TWO_SIDED|95.0|-20.16|-1.04|||||Difference in % = Arm B - Arm C|||-1.04|-20.16|
73808011|NCT01953601|147165766|OTHER||Difference in % vs Placebo|-2.42|||||TWO_SIDED|95.0|-6.03|0.61|||||Difference in % = Arm A - Arm C|||0.61|-6.03|
73808012|NCT01953601|147165766|OTHER||Difference in % vs Placebo|-2.38|||||TWO_SIDED|95.0|-6.01|0.71|||||Difference in % = Arm B - Arm C|||0.71|-6.01|
73808013|NCT01953601|147165767|SUPERIORITY||Hazard Ratio (HR)|1.301||||0.0222|TWO_SIDED|97.51|1.005|1.684|||Regression, Cox||HR = Arm A / Arm C||Based on Cox regression model with Efron's method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.|1.684|1.005|0.0222
73808014|NCT01953601|147165767|SUPERIORITY||Hazard Ratio (HR)|1.382||||0.005|TWO_SIDED|97.51|1.067|1.79|||Regression, Cox||HR = Arm B / Arm C||Based on Cox regression model with Efron's method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.|1.790|1.067|0.0050
73808015|NCT01953601|147165768|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.9109|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-0.3|0.9109
73808016|NCT01953601|147165768|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.3||||0.0824|TWO_SIDED|97.51|-0.1|0.7|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.7|-0.1|0.0824
73808017|NCT01953601|147165769|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.951|TWO_SIDED|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-0.2|0.9510
73808018|NCT01953601|147165769|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.9392|TWO_SIDED|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-0.2|0.9392
73808019|NCT01953601|147165770|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.4||||0.1133|TWO_SIDED|97.51|-1.0|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-1.0|0.1133
73808020|NCT01953601|147165770|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.6||||0.031|TWO_SIDED|97.51|-1.2|0.0|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.0|-1.2|0.0310
73895869|NCT00647270|147325233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.074|TWO_SIDED|95.0|-13.3|7.4|||Chi-squared||Treatment difference between adalimumab 80 mg monthly and placebo divided by the difference between adalimumab 40 mg eow and placebo.|Adalimumab 80 mg monthly versus placebo: The null hypothesis associated with this comparison stated that adalimumab 80 mg monthly would be inferior to placebo with respect to ACR20 response percentage; the alternative hypothesis was that adalimumab 80 mg monthly would be superior to placebo with respect to ACR20 response.||7.4|-13.3|0.074
73808021|NCT01953601|147165771|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.05|||<|0.0001|TWO_SIDED|97.51|-0.06|-0.04|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.04|-0.06|<0.0001
73808022|NCT01953601|147165771|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.06|||<|0.0001|TWO_SIDED|97.51|-0.07|-0.05|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.05|-0.07|<0.0001
73808023|NCT01953601|147165772|SUPERIORITY||Difference in Least Squares Mean (LSM)|-1.0||||0.096|TWO_SIDED|97.51|-2.4|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-2.4|0.0960
73808024|NCT01953601|147165772|SUPERIORITY||Difference in Least Squares Mean (LSM)|-1.7||||0.011|TWO_SIDED|97.51|-3.2|-0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.2|-3.2|0.0110
73808025|NCT05225298|147165774|OTHER|||||||0.9||||||A p-value of \< 0.05 would be considered statistically significant|log binomial model|||||||0.90
73808026|NCT05225298|147165775|OTHER|||||||0.94||||||A p-value of \< 0.05 would be considered statistically significant|log binomial model|||||||0.94
73808027|NCT05225298|147165776|OTHER|||||||0.053|||||||log binomial model|||||||0.053
73808028|NCT03834974|147165809|SUPERIORITY||||||<|0.0286|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in change in intent to tan outdoors 10 or more times in the next year.||||<0.0286
73808029|NCT03834974|147165809|SUPERIORITY|||||||0.0937|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in change in in intent to tan later in life.||||0.0937
73808030|NCT03834974|147165813|SUPERIORITY||||||<|0.0002|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in tanning outside at follow-up||||<0.0002
73808031|NCT05875025|147165863|OTHER||Adjusted mean difference|1.36||||0.442|TWO_SIDED|95.0|-2.28|4.99|||ANCOVA|Analysis of covariance (ANCOVA) model, included treatment, subject, and period as fixed effects; PPR2 at baseline as a covariate.||||4.99|-2.28|0.442
73808032|NCT05875025|147165864|OTHER||Adjusted mean difference|0.7||||0.553|TWO_SIDED|95.0|-1.73|3.12|||ANCOVA|Analysis of covariance (ANCOVA) model, included treatment, subject, and period as fixed effects; PPR4 at baseline as a covariate.||||3.12|-1.73|0.553
73808033|NCT01489254|147165866|NON_INFERIORITY_OR_EQUIVALENCE|To conclude study sensitivity the combined active treatment groups Glatiramer 20 mg and Copaxone 20 mg needed to be superior to placebo.|Ratio (or Ratio of estimated means)|0.488|||||TWO_SIDED|95.0|0.365|0.651|||||Ratio of combined Glatiramer 20 mg + Copaxone 20 mg to placebo and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function. To assess study sensitivity, data of the active treatment groups and placebo were included in the model, resulting in the ratios and 95% CIs for the combined Glatiramer 20 mg and Copaxone 20 mg treatment group and the individual treatments over placebo.||0.651|0.365|
73808034|NCT01489254|147165866|NON_INFERIORITY_OR_EQUIVALENCE|To conclude equivalence between Glatiramer 20 mg and Copaxone 20 mg, efficacy in the combined active treatment groups needed to be superior to placebo (confirming study sensitivity) and the 2-sided 95% CI for the estimated ratio of Glatiramer 20 mg to Copaxone 20 mg needed to be fully enclosed in the prespecified equivalence margin (0.727 - 1.375).|Ratio (or Ratio of estimated means)|1.095|||||TWO_SIDED|95.0|0.883|1.36|||||Ratio of Glatiramer 20 mg to Copaxone 20 mg and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function including Glatiramer 20 mg and Copaxone 20 mg treatment groups to assess study equivalence.||1.360|0.883|
73808035|NCT00737204|147165874|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.001
73808036|NCT00737204|147165875|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||ANCOVA|||Repeated measure analysis||||.01
73808037|NCT00737204|147165876|SUPERIORITY_OR_OTHER||||||>=|0.805||95.0|||||Paired t-tests|||Null hypothesis: CD4 levels for both the Armodafinil and Placebo groups will not change significantly between baseline and week 4.||||>=.805
73808038|NCT00281632|147165878|SUPERIORITY_OR_OTHER||Reponse rate|31.0||||||95.0|16.3|48.1|||||50% Response Rate (Normalized and Non-Normalized)|||48.1|16.3|
73808039|NCT00281632|147165882|SUPERIORITY_OR_OTHER||Response rate|17.6||||||95.0|3.8|43.4|||||Response rate (CR+PR)|||43.4|3.8|
73808040|NCT00281632|147165882|SUPERIORITY_OR_OTHER||Response rate|21.1||||||95.0|6.1|45.6|||||Response rate (CR+PR)|||45.6|6.1|
73808041|NCT00281632|147165882|SUPERIORITY_OR_OTHER||Response rate|19.4||||||95.0|8.2|36.0|||||Response rate (CR+PR)|||36.0|8.2|
73808042|NCT01945970|147165902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.36|TWO_SIDED|95.0|-1.09|0.4|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||0.40|-1.09|0.36
73808043|NCT01945970|147165903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.18|TWO_SIDED|95.0|-0.24|1.28|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||1.28|-0.24|0.18
73808044|NCT01945970|147165904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.014|TWO_SIDED|95.0|-1.59|-0.19|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||-0.19|-1.59|0.014
73808045|NCT01945970|147165905|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.49||||0.22|TWO_SIDED|95.0|-1.3|0.31|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.31|-1.30|0.22
73808046|NCT01945970|147165906|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71||||0.09|TWO_SIDED|95.0|-0.11|1.53|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||1.53|-0.11|0.09
73808047|NCT01945970|147165907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.32|TWO_SIDED|95.0|-1.13|0.37|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.37|-1.13|0.32
73808048|NCT01945970|147165908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.89||||0.14|TWO_SIDED|95.0|-0.61|4.39|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo|||4.39|-0.61|0.14
73808049|NCT01945970|147165909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED|95.0|-2.41|1.62|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo|||1.62|-2.41|0.69
73808050|NCT01945970|147165910|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.44||||0.72|TWO_SIDED|95.0|-2.06|2.95|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo|||2.95|-2.06|0.72
73808051|NCT01945970|147165911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.39|TWO_SIDED|95.0|-1.15|2.88|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo|||2.88|-1.15|0.39
73808052|NCT01945970|147165912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.74|TWO_SIDED|95.0|-1.75|1.24|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||1.24|-1.75|0.74
73808053|NCT01945970|147165913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.41|TWO_SIDED|95.0|-2.12|0.88|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||0.88|-2.12|0.41
73808054|NCT01945970|147165914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.74|TWO_SIDED|95.0|-1.11|1.54|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects||1.54|-1.11|0.74
73808055|NCT01945970|147165915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.66|TWO_SIDED|95.0|-1.84|1.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||1.17|-1.84|0.66
73808056|NCT01945970|147165916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.11|TWO_SIDED|95.0|-2.7|0.3|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.30|-2.70|0.11
73808057|NCT01945970|147165917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.55|TWO_SIDED|95.0|-0.93|1.73|||Mixed Models Analysis||Effect of positive control adjusted for placebo|||1.73|-0.93|0.55
73808058|NCT00782184|147165918|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.4|||<|0.001|TWO_SIDED|95.0|3.4|21.0|||Regression, Logistic|||COMPARISON BETWEEN GROUPS FOR NUMBER OF PARTICIPANTS REACHING LDL-C GOAL OF \<70 MG/DL||21.0|3.4|<0.001
73808059|NCT00782184|147165919|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-15.0|||<|0.001|TWO_SIDED|95.0|-21.15|-8.84|||Longitudinal Data Analysis (LDA) Model|||||-8.84|-21.15|<0.001
73808060|NCT00782184|147165920|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.7|||<|0.001|TWO_SIDED|95.0|3.3|13.9|||Regression, Logistic|||||13.9|3.3|<0.001
73808061|NCT00782184|147165921|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.0|6.0|||Regression, Logistic|||||6.0|2.0|<0.001
73808062|NCT00782184|147165922|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-8.24|||<|0.001|TWO_SIDED|95.0|-12.5|-3.97|||LDA Model|||||-3.97|-12.50|<0.001
73808063|NCT00782184|147165923|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.13||||0.593|TWO_SIDED|95.0|-5.67|9.93|||LDA Model|||||9.93|-5.67|0.593
73808064|NCT00782184|147165924|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.48||||0.211|TWO_SIDED|95.0|-1.41|6.37|||LDA Model|||||6.37|-1.41|0.211
73808065|NCT00782184|147165925|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-11.62|||<|0.001|TWO_SIDED|95.0|-17.32|-5.92|||LDA Model|||||-5.92|-17.32|<0.001
73808066|NCT00782184|147165926|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-16.1|||<|0.001|TWO_SIDED|95.0|-22.77|-9.44|||LDA Model|||||-9.44|-22.77|<0.001
73808067|NCT00782184|147165927|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-10.02|||<|0.001|TWO_SIDED|95.0|-14.96|-5.08|||LDA Model|||||-5.08|-14.96|<0.001
73808068|NCT00782184|147165928|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.21|||<|0.001|TWO_SIDED|95.0|-19.83|-6.59|||LDA Model|||||-6.59|-19.83|<0.001
73808069|NCT00782184|147165929|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-7.69||||0.002|TWO_SIDED|95.0|-12.5|-2.88|||LDA Model|||||-2.88|-12.50|0.002
73808070|NCT00782184|147165930|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|5.25|||<|0.001|TWO_SIDED|95.0|2.44|8.06|||LDA Model|||||8.06|2.44|<0.001
73808071|NCT00782184|147165931|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.91|||<|0.001|TWO_SIDED|95.0|-18.31|-7.52|||LDA Model|||||-7.52|-18.31|<0.001
73808072|NCT00782184|147165932|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.68||||0.785|TWO_SIDED|95.0|-16.5|21.86|||LDA Model|||||21.86|-16.50|0.785
73808073|NCT01369108|147165938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||ANOVA|||null hypothesis no difference in anatomic form||||0.8
73808074|NCT01369108|147165938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||ANOVA|||null hypothesis no difference in margin adaptation||||0.89
73808075|NCT01369108|147165938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||ANOVA|||null hypothesis no difference in margin discoloration||||0.79
73808076|NCT01369108|147165938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||ANOVA|||null hypothesis no difference in surface integrity||||0.18
73808077|NCT01369108|147165938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||ANOVA|||null hypothesis no difference in secondary caries||||0.66
73808078|NCT01369108|147165939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522|||||||ANOVA|||null hypothesis no difference in sensitivity to cold||||0.522
73895870|NCT00647270|147325233|NON_INFERIORITY_OR_EQUIVALENCE|A sensitivity analysis was proposed for the non-inferiority comparison. If the lower confidence limit of θ80 - θ40 was greater than -0.1, then the non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg eow would be claimed||||||0.74||95.0||||Non - inferiority of adalimumab 80 mg monthly compared with 40 mg eow could not be tested because the null hypothesis of the first comparison was not rejected.|Chi-squared|||The non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg every other week (eow) was to be claimed if at least 50% of the treatment effect of adalimumab 40 mg eow over placebo was to be achieved by adalimumab 80 mg monthly over placebo.||||0.74
73808079|NCT01369108|147165939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.449|||||||Chi-squared|||null hypothesis no difference in biting pressure||||.449
73808080|NCT04143594|147165944|SUPERIORITY||Difference in percentage|-2.6||||0.7178|TWO_SIDED|95.0|-18.4|13.2||P-value was from the Cochran-Mantel-Haenszel (CMH) tests stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing and the B/F/TAF groups, and its 95% confidence interval (CI) were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||13.2|-18.4|0.7178
73808081|NCT04143594|147165944|SUPERIORITY||Difference in percentage|-7.1||||0.39|TWO_SIDED|95.0|-23.4|9.3||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.3|-23.4|0.3900
73808082|NCT04143594|147165944|SUPERIORITY||Difference in percentage|-7.2||||0.3797|TWO_SIDED|95.0|-23.5|9.1||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.1|-23.5|0.3797
73808083|NCT04143594|147165945|SUPERIORITY||Difference in percentage|-5.5||||0.2398|TWO_SIDED|95.0|-15.9|4.8||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||4.8|-15.9|0.2398
73808084|NCT04143594|147165945|SUPERIORITY||Difference in percentage|-7.4||||0.1639|TWO_SIDED|95.0|-18.3|3.4||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||3.4|-18.3|0.1639
73808085|NCT04143594|147165945|SUPERIORITY||Difference in percentage|-5.7||||0.2307|TWO_SIDED|95.0|-16.3|4.9||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||4.9|-16.3|0.2307
73808086|NCT04143594|147165946|SUPERIORITY||Difference in percentage|-6.7||||0.3142|TWO_SIDED|95.0|-20.7|7.3||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||7.3|-20.7|0.3142
73808087|NCT04143594|147165946|SUPERIORITY||Difference in percentage|-7.2||||0.3009|TWO_SIDED|95.0|-21.3|6.8||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||6.8|-21.3|0.3009
73808088|NCT04143594|147165946|SUPERIORITY||Difference in percentage|-7.6||||0.2859|TWO_SIDED|95.0|-21.8|6.7||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||6.7|-21.8|0.2859
73808089|NCT04143594|147165947|SUPERIORITY||Difference in percentage|-7.1||||0.3686|TWO_SIDED|95.0|-23.2|9.0||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.0|-23.2|0.3686
73808090|NCT04143594|147165947|SUPERIORITY||Difference in percentage|-16.5||||0.0887|TWO_SIDED|95.0|-34.0|1.0||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||1.0|-34.0|0.0887
73808091|NCT04143594|147165947|SUPERIORITY||Difference in percentage|-5.4||||0.4949|TWO_SIDED|95.0|-21.5|10.7||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||10.7|-21.5|0.4949
73808092|NCT04143594|147165948|SUPERIORITY||Difference in LSM|0.08||||0.5755|TWO_SIDED|95.0|-0.2|0.37||P-value was from analysis of variance (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.37|-0.20|0.5755
73808093|NCT04143594|147165948|SUPERIORITY||Difference in LSM|0.02||||0.8697|TWO_SIDED|95.0|-0.25|0.29||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.29|-0.25|0.8697
73808094|NCT04143594|147165948|SUPERIORITY||Difference in LSM|0.06||||0.7052|TWO_SIDED|95.0|-0.23|0.35||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.35|-0.23|0.7052
73808095|NCT04143594|147165949|SUPERIORITY||Difference in LSM|0.02||||0.8942|TWO_SIDED|95.0|-0.26|0.3||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.30|-0.26|0.8942
73808096|NCT04143594|147165949|SUPERIORITY||Difference in LSM|-0.02||||0.9058|TWO_SIDED|95.0|-0.28|0.25||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.25|-0.28|0.9058
73808097|NCT04143594|147165949|SUPERIORITY||Difference in LSM|0.04||||0.8129|TWO_SIDED|95.0|-0.27|0.35||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.35|-0.27|0.8129
73895871|NCT00647270|147325234|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
73808098|NCT04143594|147165950|SUPERIORITY||Difference in LSM|0.04||||0.7864|TWO_SIDED|95.0|-0.25|0.33||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.33|-0.25|0.7864
73808099|NCT04143594|147165950|SUPERIORITY||Difference in LSM|-0.05||||0.7013|TWO_SIDED|95.0|-0.31|0.21||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.21|-0.31|0.7013
73808100|NCT04143594|147165950|SUPERIORITY||Difference in LSM|0.22||||0.2753|TWO_SIDED|95.0|-0.18|0.62||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.62|-0.18|0.2753
73808101|NCT04143594|147165951|SUPERIORITY||Difference in LSM|0.08||||0.564|TWO_SIDED|95.0|-0.19|0.34||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.34|-0.19|0.5640
73808102|NCT04143594|147165951|SUPERIORITY||Difference in LSM|-0.01||||0.9555|TWO_SIDED|95.0|-0.28|0.26||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.26|-0.28|0.9555
73808103|NCT04143594|147165951|SUPERIORITY||Difference in LSM|0.14||||0.4025|TWO_SIDED|95.0|-0.19|0.46||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.46|-0.19|0.4025
73808104|NCT04143594|147165952|SUPERIORITY||Difference in LSM|12.0||||0.7751|TWO_SIDED|95.0|-73.0|97.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||97|-73|0.7751
73808105|NCT04143594|147165952|SUPERIORITY||Difference in LSM|-2.0||||0.9549|TWO_SIDED|95.0|-79.0|75.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||75|-79|0.9549
73808106|NCT04143594|147165952|SUPERIORITY||Difference in LSM|44.0||||0.2603|TWO_SIDED|95.0|-33.0|120.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||120|-33|0.2603
73808107|NCT04143594|147165953|SUPERIORITY||Difference in LSM|-31.0||||0.4827|TWO_SIDED|95.0|-119.0|57.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||57|-119|0.4827
73808108|NCT04143594|147165953|SUPERIORITY||Difference in LSM|-12.0||||0.7963|TWO_SIDED|95.0|-106.0|81.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||81|-106|0.7963
73808109|NCT04143594|147165953|SUPERIORITY||Difference in LSM|-22.0||||0.6169|TWO_SIDED|95.0|-111.0|67.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||67|-111|0.6169
73808110|NCT04143594|147165954|SUPERIORITY||Difference in LSM|21.0||||0.6614|TWO_SIDED|95.0|-73.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-73|0.6614
73808111|NCT04143594|147165954|SUPERIORITY||Difference in LSM|20.0||||0.6791|TWO_SIDED|95.0|-75.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-75|0.6791
73808112|NCT04143594|147165954|SUPERIORITY||Difference in LSM|27.0||||0.5563|TWO_SIDED|95.0|-65.0|120.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||120|-65|0.5563
73808113|NCT04143594|147165955|SUPERIORITY||Difference in LSM|32.0||||0.5492|TWO_SIDED|95.0|-75.0|140.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||140|-75|0.5492
73808114|NCT04143594|147165955|SUPERIORITY||Difference in LSM|17.0||||0.722|TWO_SIDED|95.0|-80.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|Difference in LSM||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-80|0.7220
73808115|NCT04143594|147165955|SUPERIORITY||Difference in LSM|-4.0||||0.9486|TWO_SIDED|95.0|-118.0|110.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||110|-118|0.9486
73808116|NCT00282113|147165994|SUPERIORITY_OR_OTHER||||||>|0.5||95.0|||||Mixed-effects regression|||||||>0.5
73808117|NCT00282113|147165995|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
73808118|NCT00282113|147165996|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
73808119|NCT02949843|147166002|OTHER|||||||0.6|||||||Fisher Exact|||Null Hypothesis is that each arm has equal rates of smoking history.||||0.6
73808120|NCT00474201|147166003|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|Students paired, two-tailed T-test||"Null hypothesis: lopinavir-ritonavir does not alter gemfibrozil pharmacokinetics.~A sample size of 13 healthy subjects yielded 81% power to detect a clinically relevant change of 30% in gemfibrozil AUC with concomitant lopinavir-ritonavir (alpha = 0.05; beta = 0.2). Gemfibrozil pharmacokinetic parameters derived pre- and post lopinavir-ritonavir exposure (Days 1 and 14, respectively) were compared using a paired Students t test."||||<0.0001
73808121|NCT01500187|147166004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.636|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at baseline||||0.636
73808122|NCT01500187|147166004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at three months||||0.001
73808123|NCT01500187|147166004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.423|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at six months||||0.423
73808124|NCT02784613|147166016|SUPERIORITY|||||||0.05||||||Differences in pre- and post-treatment scores were compared using Wilcoxon signed-rank test for non-parametric matched pairs. All tests of significance were 2-tailed. All analyses were performed in Stata®, version 13.|t-test, 2 sided|||||||0.05
73808125|NCT01551264|147166034|OTHER|P-value by chi-square comparing the Kaplan-Meier recurrence-free survival probability at 1.2 years post treatment with robust estimate of standard error due to the a priori assumption that data from bilateral limbs are correlated.||||||0.03|||||||Chi-squared|||||||0.03
73808126|NCT01582178|147166047|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Fisher Exact|||||||0.89
73808127|NCT00556933|147166050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED||||||Chi-squared|||||||0.0004
73808128|NCT00556933|147166051|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|TWO_SIDED||||||General Linear Model|||||||0.45
73808129|NCT00556933|147166052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|TWO_SIDED||||||Fisher Exact|||||||0.53
73808130|NCT00556933|147166053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463|TWO_SIDED||||||Fisher Exact|||||||0.463
73808131|NCT00556933|147166054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||Kaplan-Meier|||||||0.67
73808132|NCT00556933|147166055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|TWO_SIDED||||||Fisher Exact|||||||0.193
73808133|NCT00556933|147166056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|TWO_SIDED||||||Fisher Exact|||||||0.422
73808134|NCT00556933|147166057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.871|TWO_SIDED||||||Fisher Exact|||||||0.871
73808135|NCT00556933|147166058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|TWO_SIDED||||||Kruskal-Wallis|||||||0.068
73808136|NCT00556933|147166059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
73808137|NCT00556933|147166060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|TWO_SIDED||||||Fisher Exact|||||||0.21
73808138|NCT00556933|147166061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Kruskal-Wallis|||||||0.40
73808139|NCT00688662|147166107|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.6||||0.01|TWO_SIDED|95.0|-28.0|-3.3||The primary analysis was conducted using a logistic regression model with treatment group as the factor of interest and clinical center and PSH status as covariates. A Wald test using a two-tailed significance level of 0.0499 was conducted.|Regression, Logistic|Adjusted and unadjusted risk differences with two-sided 95% confidence intervals are reported in the manuscript.|The unadjusted risk difference and confidence interval was -14.3% (-27.3%, -1.2%).|The trial was designed to test for an overall absolute difference of at least 30% in the primary outcome ('success') in patients treated with sphincterotomy compared to those treated with sham. Using a 2:1 allocation, an assumed 10% non-adherence rate, and one interim analysis for efficacy using O'Brien and Fleming boundaries and futility using conditional power, the study required 214 patients to be randomized to ensure greater than 90% likelihood of identifying this difference.||-3.3|-28.0|0.01
73808140|NCT00688662|147166108|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.0|||||TWO_SIDED|95.0|-24.1|5.9||A confidence interval approach was used for examining this outcome.||||Only patients with abnormal manometry were included in this subgroup analysis.||5.9|-24.1|
73808141|NCT00746564|147166109|SUPERIORITY_OR_OTHER||percentage of recordings|100.0|||||TWO_SIDED|95.0|100.0|100.0||||||"The sensitivity was calculated for each recording and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|100|
73808142|NCT00746564|147166110|SUPERIORITY_OR_OTHER||percentage of clinical recordings|98.1|||||TWO_SIDED|95.0|95.7|100.0||||||"The sensitivity was calculated for each recording during the treadmill test and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|95.7|
73808143|NCT00746564|147166111|SUPERIORITY_OR_OTHER||percentage of recordings|98.0|||||TWO_SIDED|95.0|95.5|100.0||||||"The sensitivity was calculated for each recording and for each subject during the hand to hand and hand to shoulder maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|95.5|
73808144|NCT00746564|147166112|SUPERIORITY_OR_OTHER||percentage of recordings|98.9|||||TWO_SIDED|95.0|96.7|100.0||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during the in-clinic recording at rest as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||100|96.7|
73808145|NCT00746564|147166113|SUPERIORITY_OR_OTHER||percentage of recording|77.1|||||TWO_SIDED|95.0|65.9|88.4||||||"The positive predictive value (PPV) was calculated for each recording and for each subject for the in-clinic recording during the treadmill exercise as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||88.4|65.9|
73808146|NCT00746564|147166114|SUPERIORITY_OR_OTHER||Percentage of recordings|85.0|||||TWO_SIDED|95.0|78.3|91.7||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during Hand to Hand and Hand to Shoulder Maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||91.7|78.3|
73808147|NCT00746564|147166115|SUPERIORITY_OR_OTHER||percentage of interpretable recording|99.2|||||TWO_SIDED|95.0|98.5|100.0||||||"The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject as follows:~Duration (sec) of interpretable recording / Total duration of recording time (sec)"||100|98.5|
73808148|NCT00746564|147166116|SUPERIORITY_OR_OTHER||percentage of interpretable recording|92.3|||||TWO_SIDED|95.0|91.9|92.6||||||"The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject was calculated as follows:~Duration of interpretable recording / Total duration of recording time"||92.6|91.9|
73808149|NCT00746564|147166117|SUPERIORITY_OR_OTHER||percentage of inappropriate recordings|86.2|||||TWO_SIDED|95.0|79.4|91.0||||||||91.0|79.4|
73808150|NCT00746564|147166118|SUPERIORITY_OR_OTHER||percentage of inappropriate recordings|63.2|||||TWO_SIDED|95.0|48.1|76.2||||||||76.2|48.1|
73808151|NCT01516008|147166134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|76.35|||<|0.001|TWO_SIDED|95.0|51.0|101.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|||101.7|51.0|<0.001
73808152|NCT01516008|147166134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|90.6|||<|0.001|TWO_SIDED|95.0|65.1|116.1||P-value is adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|||116.1|65.1|<0.001
73808153|NCT01516008|147166135|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center||||||<0.001
73808154|NCT01516008|147166135|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center||||||<0.001
73808155|NCT01516008|147166136|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours||||<0.001
73808156|NCT01516008|147166136|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours||||<0.001
73808157|NCT01516008|147166136|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours||||0.001
73808158|NCT01516008|147166136|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours||||<0.001
73808159|NCT01516008|147166136|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours||||<0.001
73808160|NCT01516008|147166136|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours||||<0.001
73808161|NCT01516008|147166136|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours||||0.001
73808162|NCT01516008|147166136|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours||||<0.001
73808163|NCT01516008|147166137|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||0.001
73808164|NCT01516008|147166137|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
73808165|NCT01516008|147166137|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
73808166|NCT01516008|147166137|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
73808167|NCT01516008|147166137|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
73808168|NCT01516008|147166137|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
73808169|NCT01516008|147166137|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
73808170|NCT01516008|147166137|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
73808171|NCT01516008|147166138|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
73808172|NCT01516008|147166138|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
73808173|NCT01516008|147166138|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||0.021
73808174|NCT01516008|147166138|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
73808175|NCT01516008|147166138|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
73808176|NCT01516008|147166138|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
73808177|NCT01516008|147166138|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
73808178|NCT01516008|147166138|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
73808179|NCT01516008|147166139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.52|||<|0.001|TWO_SIDED|95.0|11.1|22.0|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours||22.0|11.1|<0.001
73808180|NCT01516008|147166139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.11|||<|0.001|TWO_SIDED|95.0|13.6|24.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours||24.6|13.6|<0.001
73808181|NCT01516008|147166139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.71|||<|0.001|TWO_SIDED|95.0|23.2|46.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours||46.2|23.2|<0.001
73808182|NCT01516008|147166139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.04|||<|0.001|TWO_SIDED|95.0|31.5|54.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours||54.6|31.5|<0.001
73808183|NCT01516008|147166139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.32|||<|0.001|TWO_SIDED|95.0|81.8|162.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours||162.9|81.8|<0.001
73808184|NCT01516008|147166139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|138.57|||<|0.001||95.0|97.8|179.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours||179.4|97.8|<0.001
73808185|NCT01516008|147166140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.15|||<|0.001|TWO_SIDED|95.0|5.0|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours||9.3|5.0|<0.001
73808186|NCT01516008|147166140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.13|||<|0.001|TWO_SIDED|95.0|4.9|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours||9.3|4.9|<0.001
73808187|NCT01516008|147166140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.21|||<|0.001|TWO_SIDED|95.0|10.6|19.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours||19.8|10.6|<0.001
73808188|NCT01516008|147166140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.54|||<|0.001|TWO_SIDED|95.0|10.9|20.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours||20.2|10.9|<0.001
73808189|NCT01516008|147166140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.76|||<|0.001|TWO_SIDED|95.0|24.3|45.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours||45.3|24.3|<0.001
73808190|NCT01516008|147166140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.6|||<|0.001|TWO_SIDED|95.0|23.0|44.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours||44.2|23.0|<0.001
73808191|NCT01516008|147166140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|56.59|||<|0.001|TWO_SIDED|95.0|39.4|73.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours||73.8|39.4|<0.001
73808192|NCT01516008|147166140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|53.48|||<|0.001|TWO_SIDED|95.0|36.2|70.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours||70.8|36.2|<0.001
73808193|NCT01516008|147166141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.66|||<|0.001|TWO_SIDED|95.0|16.4|30.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours||30.9|16.4|<0.001
73808194|NCT01516008|147166141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.24|||<|0.001|TWO_SIDED|95.0|18.9|33.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours||33.6|18.9|<0.001
73808195|NCT01516008|147166141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.93|||<|0.001|TWO_SIDED|95.0|34.4|65.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours||65.4|34.4|<0.001
73808196|NCT01516008|147166141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|58.58|||<|0.001|TWO_SIDED|95.0|43.0|74.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours||74.2|43.0|<0.001
73808197|NCT01516008|147166141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|111.12|||<|0.001||95.0|76.3|145.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours||145.9|76.3|<0.001
73808198|NCT01516008|147166141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|124.21|||<|0.001|TWO_SIDED|95.0|89.2|159.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours||159.2|89.2|<0.001
73808199|NCT01516008|147166141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|178.91|||<|0.001|TWO_SIDED|95.0|122.4|235.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours||235.4|122.4|<0.001
73808200|NCT01516008|147166141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|192.05|||<|0.001|TWO_SIDED|95.0|135.2|248.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours||248.9|135.2|<0.001
73808201|NCT01516008|147166142|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||||||<0.001
73808202|NCT01516008|147166142|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||||||<0.001
73808203|NCT03963232|147166147|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.32|-1.32|||Mixed Models Analysis|||||-1.32|-2.32|<.0001
73808204|NCT03963232|147166148|SUPERIORITY||Odds Ratio (OR)|2.674|||<|0.0001|TWO_SIDED|95.0|2.01|3.557|||GLIMMIX|||30% responder||3.557|2.010|<.0001
73808205|NCT03963232|147166148|SUPERIORITY||Odds Ratio (OR)|2.481|||<|0.0001|TWO_SIDED|95.0|1.869|3.293|||GLIMMIX|||50% responder||3.293|1.869|<.0001
73808206|NCT03963232|147166148|SUPERIORITY||Odds Ratio (OR)|2.824|||<|0.0001|TWO_SIDED|95.0|2.007|3.972|||GLIMMIX|||75% responder||3.972|2.007|<.0001
73808207|NCT03963232|147166148|SUPERIORITY||Odds Ratio (OR)|3.309|||<|0.0001|TWO_SIDED|95.0|1.989|5.504|||GLIMMIX|||100% responder||5.504|1.989|<.0001
73808208|NCT03963232|147166149|SUPERIORITY||LS Mean Difference|7.07|STANDARD_DEVIATION|0.95|<|0.0001|TWO_SIDED|95.0|5.2|8.95|||Mixed Models Analysis|||||8.95|5.20|<.0001
73808209|NCT03963232|147166150|SUPERIORITY||LS Mean Difference|-1.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.25|-1.31|||Mixed Models Analysis|||||-1.31|-2.25|<.0001
73808210|NCT03963232|147166151|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.35|-1.29|||Mixed Models Analysis|||||-1.29|-2.35|<.0001
73808211|NCT03963232|147166152|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.92|4.81|||Regression, Logistic|||||4.81|1.92|<.0001
73808212|NCT03963232|147166153|SUPERIORITY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.15|-0.62|||Mixed Models Analysis|||||-0.62|-1.15|<.0001
73808213|NCT03963232|147166154|SUPERIORITY||LS Mean Difference|-18.88|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001|TWO_SIDED|95.0|-23.21|-14.56|||Mixed Models Analysis|||||-14.56|-23.21|<.0001
73808214|NCT03963232|147166155|SUPERIORITY||LS Mean Difference|-19.24|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED|95.0|-23.73|-14.75|||Mixed Models Analysis|||||-14.75|-23.73|<.0001
73808215|NCT03963232|147166156|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.22|-0.1|||Mixed Models Analysis|||||-0.10|-0.22|<.0001
73808216|NCT03963232|147166157|SUPERIORITY||LS Mean Difference|-0.224|STANDARD_ERROR_OF_MEAN|0.1021||0.0284|TWO_SIDED|95.0|-0.43|-0.02|||ANCOVA|||||-0.02|-0.43|0.0284
73808217|NCT03963232|147166158|SUPERIORITY||LS Mean Difference|-12.429|STANDARD_ERROR_OF_MEAN|3.2484||0.0001|TWO_SIDED|95.0|-18.81|-6.05|||ANCOVA|||||-6.05|-18.81|0.0001
73808218|NCT00356135|147166166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.91|||<|0.0001||95.0|-19.1|-8.73|||ANOVA|Treatment and study sites are fixed effects and MPA right before the randomization treatment period is a covariate in the model.|Mean Difference is for Prasugrel 10/10 mg arm minus Clopidogrel 75/75 mg arm.|||-8.73|-19.10|<0.0001
73808219|NCT00356135|147166166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.98|||<|0.0001||95.0|-19.26|-8.71|||ANCOVA|||||-8.71|-19.26|<0.0001
73808220|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.4||||0.4055|TWO_SIDED|95.0|-8.22|3.35||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.35|-8.22|0.4055
73808221|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-29.3|-17.51||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-17.51|-29.30|<0.0001
73808222|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.2||||0.068|TWO_SIDED|95.0|-8.82|0.32||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||0.32|-8.82|0.0680
73808223|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-29.0|||<|0.0001|TWO_SIDED|95.0|-33.2|-23.94||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|Comparison of MPA to 20 uM ADP at 24 hours||-23.94|-33.20|<0.0001
73808224|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.96|-9.65||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-9.65|-19.96|<0.0001
73808225|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.87|-9.32||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-9.32|-19.87|<0.0001
73808226|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.3|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-9.22|-20.30|<0.0001
73808227|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.59|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-9.22|-20.59|<0.0001
73808228|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4||||0.5501|TWO_SIDED|95.0|-5.85|3.14||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.14|-5.85|0.5501
73808229|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-17.0|||<|0.0001|TWO_SIDED|95.0|-21.55|-12.37||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-12.37|-21.55|<0.0001
73808230|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.1||||0.0752|TWO_SIDED|95.0|-8.58|0.42||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||0.42|-8.58|0.0752
73808231|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.0|||<|0.0001|TWO_SIDED|95.0|-24.81|-15.64||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-15.64|-24.81|<0.0001
73808232|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|||<|0.0001|TWO_SIDED|95.0|-17.21|-7.5||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.50|-17.21|<0.0001
73808233|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.79|-5.79||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-5.79|-15.79|<0.0001
73808234|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-17.41|-7.72||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.72|-17.41|<0.0001
73808235|NCT00356135|147166167|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|||<|0.0001|TWO_SIDED|95.0|-16.8|-6.82||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.82|-16.80|<0.0001
73808236|NCT00356135|147166168|SUPERIORITY_OR_OTHER|||||||0.1824|||||||t-test, 2 sided|||The mean of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the mean MPA of patients not using clopidogrel at this time.||||0.1824
73808237|NCT00356135|147166168|SUPERIORITY_OR_OTHER|||||||0.1101|||||||F-test|||The variance of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the variance of MPA for patients not using clopidogrel at this time.||||0.1101
73808238|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.1||||0.3466|TWO_SIDED|95.0|-9.5|3.37||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.37|-9.50|0.3466
73808239|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-27.0|||<|0.0001|TWO_SIDED|95.0|-33.4|-20.33||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-20.33|-33.40|<0.0001
73808240|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.3||||0.0127|TWO_SIDED|95.0|-13.04|-1.6||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-1.60|-13.04|0.0127
73808241|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-34.0|||<|0.0001|TWO_SIDED|95.0|-39.99|-28.42||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-28.42|-39.99|<0.0001
73808242|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-18.0|||<|0.0001|TWO_SIDED|95.0|-25.58|-11.09||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-11.09|-25.58|<0.0001
73808243|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.0|||<|0.0001|TWO_SIDED|95.0|-27.09|-12.26||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-12.26|-27.09|<0.0001
73808244|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-28.42|-14.77||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-14.77|-28.42|<0.0001
73808245|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-29.61|-15.63||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-15.63|-29.61|<0.0001
73808246|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.6||||0.4954|TWO_SIDED|95.0|-3.11|6.38||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||6.38|-3.11|0.4954
73808247|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.92|-6.24||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.24|-15.92|<0.0001
73808248|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.3||||0.1971|TWO_SIDED|95.0|-8.31|1.74||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||1.74|-8.31|0.1971
73808249|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.0|||<|0.0001|TWO_SIDED|95.0|-20.98|-10.75||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-10.75|-20.98|<0.0001
73808250|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-18.81|-7.32||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.32|-18.81|<0.0001
73808251|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0||||0.0001|TWO_SIDED|95.0|-17.91|-6.09||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.09|-17.91|0.0001
73808252|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.64|-6.32||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-6.32|-15.64|<0.0001
73808253|NCT00356135|147166169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.67|-5.09||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-5.09|-14.67|<0.0001
73808254|NCT00356135|147166170|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0005
73808255|NCT00356135|147166170|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||<0.0001
73808256|NCT00356135|147166170|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0150
73808257|NCT00356135|147166170|SUPERIORITY_OR_OTHER|||||||0.0152||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0152
73808258|NCT00356135|147166170|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0153
73808259|NCT00356135|147166170|SUPERIORITY_OR_OTHER|||||||0.0018||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0018
73808260|NCT01106677|147166197|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.758|-0.481|||ANCOVA|||||-0.481|-0.758|<0.001
73808261|NCT01106677|147166197|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.914|-0.636|||ANCOVA|||||-0.636|-0.914|<0.001
73808262|NCT01106677|147166197|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|95.0|-0.795|-0.516||No formal statistical comparison was conducted.|ANCOVA|||||-0.516|-0.795|
73895872|NCT00647270|147325235|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.005
73808263|NCT01106677|147166198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29|||<|0.001|TWO_SIDED|95.0|1.5|3.5|||Regression, Logistic|||||3.50|1.50|<0.001
73808264|NCT01106677|147166198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.39|||<|0.001|TWO_SIDED|95.0|2.85|6.77|||Regression, Logistic|||||6.77|2.85|<0.001
73808265|NCT01106677|147166199|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-29.8|STANDARD_ERROR_OF_MEAN|3.044|<|0.001|TWO_SIDED|95.0|-35.76|-23.81|||ANCOVA|||||-23.81|-35.76|<0.001
73808266|NCT01106677|147166199|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-40.3|STANDARD_ERROR_OF_MEAN|3.055|<|0.001|TWO_SIDED|95.0|-46.25|-34.26|||ANCOVA|||||-34.26|-46.25|<0.001
73808267|NCT01106677|147166199|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-28.7|-16.69||No formal statistical comparison was conducted.|ANCOVA|||||-16.69|-28.70|
73808268|NCT01106677|147166200|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-38.1|STANDARD_ERROR_OF_MEAN|5.601|<|0.001|TWO_SIDED|95.0|-49.14|-27.16|||ANCOVA|||||-27.16|-49.14|<0.001
73808269|NCT01106677|147166200|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|5.635|<|0.001|TWO_SIDED|95.0|-58.4|-36.29|||ANCOVA|||||-36.29|-58.40|<0.001
73808270|NCT01106677|147166200|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-39.6|STANDARD_ERROR_OF_MEAN|5.608|||TWO_SIDED|95.0|-50.56|-28.55||No formal statistical comparison was conducted.|ANCOVA|||||-28.55|-50.56|
73808271|NCT01106677|147166201|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.1|-1.9|||ANCOVA|||||-1.9|-3.1|<0.001
73808272|NCT01106677|147166201|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.5|-2.3|||ANCOVA|||||-2.3|-3.5|<0.001
73808273|NCT01106677|147166201|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.6|0.6||No formal statistical comparison was conducted.|ANCOVA|||||0.6|-0.6|
73808274|NCT01106677|147166202|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.36|STANDARD_ERROR_OF_MEAN|0.979|<|0.001|TWO_SIDED|95.0|-7.28|-3.439|||ANCOVA|||||-3.439|-7.280|<0.001
73808275|NCT01106677|147166202|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-6.58|STANDARD_ERROR_OF_MEAN|0.981|<|0.001|TWO_SIDED|95.0|-8.504|-4.653|||ANCOVA|||||-4.653|-8.504|<0.001
73808276|NCT01106677|147166202|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.34|STANDARD_ERROR_OF_MEAN|0.984|||TWO_SIDED|95.0|-5.273|-1.413||No formal statistical comparison was conducted.|ANCOVA|||||-1.413|-5.273|
73808277|NCT01106677|147166203|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|4.2||0.702||95.0|-9.9|6.7|||ANCOVA|||||6.7|-9.9|0.702
73808278|NCT01106677|147166203|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|4.3||0.274|TWO_SIDED|95.0|-13.0|3.7|||ANCOVA|||||3.7|-13.0|0.274
73808279|NCT01106677|147166203|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-10.6|6.1||No formal statistical comparison was conducted.|ANCOVA|||||6.1|-10.6|
73808280|NCT01106677|147166204|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|3.6|9.7|||ANCOVA|||||9.7|3.6|<0.001
73808281|NCT01106677|147166204|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|8.5|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|5.4|11.5|||ANCOVA|||||11.5|5.4|<0.001
73808282|NCT01106677|147166204|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|95.0|-1.7|4.4||No formal statistical comparison was conducted.|ANCOVA|||||4.4|-1.7|
73808283|NCT01106677|147166205|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.061|||TWO_SIDED|95.0|-0.119|0.122|||ANCOVA|||||0.122|-0.119|
73808284|NCT01106677|147166205|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.062|||TWO_SIDED|95.0|-0.273|-0.031|||ANCOVA|||||-0.031|-0.273|
73808285|NCT01106677|147166206|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-8.55|STANDARD_ERROR_OF_MEAN|2.394|<|0.001|TWO_SIDED|95.0|-13.25|-3.857|||ANCOVA|||||-3.857|-13.25|<0.001
73808286|NCT01106677|147166206|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-17.5|STANDARD_ERROR_OF_MEAN|2.404|<|0.001|TWO_SIDED|95.0|-22.24|-12.81|||ANCOVA|||||-12.81|-22.24|<0.001
73808287|NCT01106677|147166207|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.0|-1.8|||ANCOVA|||||-1.8|-3.0|<0.001
73808288|NCT01106677|147166207|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.4|-2.3|||ANCOVA|||||-2.3|-3.4|<0.001
73808289|NCT01106677|147166208|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.87|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|-4.464|-1.276|||ANCOVA|||||-1.276|-4.464|<0.001
73808290|NCT01106677|147166208|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.99|STANDARD_ERROR_OF_MEAN|0.815|<|0.001|TWO_SIDED|95.0|-5.589|-2.389|||ANCOVA|||||-2.389|-5.589|<0.001
73808291|NCT01106677|147166209|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|3.2||0.466|TWO_SIDED|95.0|-3.9|8.5|||ANCOVA|||||8.5|-3.9|0.466
73808292|NCT01106677|147166209|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.2||0.323|TWO_SIDED|95.0|-3.1|9.4|||ANCOVA|||||9.4|-3.1|0.323
73895873|NCT00647270|147325235|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
73808293|NCT01106677|147166210|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.5|8.0|||ANCOVA|||||8.0|2.5|<0.001
73808294|NCT01106677|147166210|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|4.5|10.1|||ANCOVA|||||10.1|4.5|<0.001
73808295|NCT03937908|147166211|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.01|||||||t-test, 2 sided|||Asiatic acid||||0.01
73808296|NCT03937908|147166211|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Caffeic acid||||0.23
73808297|NCT03937908|147166211|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.001||||||Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Dihydrocaffeic acid||||0.001
73808298|NCT03937908|147166211|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||Dihydroferulic acid||||0.05
73808299|NCT03937908|147166211|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.07|||||||t-test, 2 sided|||Ferulic acid||||0.07
73808300|NCT03937908|147166211|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.09|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.09
73808301|NCT03937908|147166211|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.003|||||||t-test, 2 sided|||Isoferulic acid||||0.003
73808302|NCT03937908|147166211|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 2 sided|||Madecassic acid||||0.10
73808303|NCT03937908|147166211|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.11|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.11
73808304|NCT03937908|147166212|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.82|||||||t-test, 2 sided|||Asiatic acid||||0.82
73808305|NCT03937908|147166212|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Caffeic acid||||0.40
73808306|NCT03937908|147166212|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.2|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.20
73808307|NCT03937908|147166212|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.48|||||||t-test, 2 sided|||Dihydroferulic acid||||0.48
73808308|NCT03937908|147166212|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.2|||||||t-test, 2 sided|||Ferulic acid||||0.20
73808309|NCT03937908|147166212|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.32|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.32
73808310|NCT03937908|147166212|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.35|||||||t-test, 2 sided|||Isoferulic acid||||0.35
73808311|NCT03937908|147166212|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.52|||||||t-test, 2 sided|||Madecassic acid||||0.52
73808312|NCT03937908|147166212|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.13|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.13
73808313|NCT03937908|147166213|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.34|||||||t-test, 2 sided|||Asiatic acid||||0.34
73808314|NCT03937908|147166213|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.08|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.08
73808315|NCT03937908|147166213|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Dihydroferulic acid||||0.23
73808316|NCT03937908|147166213|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.14|||||||t-test, 2 sided|||Ferulic acid||||0.14
73808317|NCT03937908|147166213|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.28|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.28
73808318|NCT03937908|147166213|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.17|||||||t-test, 2 sided|||Isoferulic acid||||0.17
73895874|NCT00647270|147325236|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||The ANCOVA Model was adjusted for the Baseline Measure.|ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
73895875|NCT00647270|147325237|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The ANCOVA Model was adjusted for Baseline Measure.|ANCOVA|The ANCOVA Model was adjusted for Baseline Measure.||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.005
73808319|NCT03937908|147166213|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.98|||||||t-test, 2 sided|||Madecassic acid||||0.98
73895876|NCT00763698|147325281|SUPERIORITY_OR_OTHER||Objective Performance Criteria|80.0|||||ONE_SIDED|95.0|5.0||||Kaplan-Meier Survival Analysis|||The objective performance criteria established for freedom from left ventricular lead related complications at 3 months was greater than 80%. At least 80% of the patients were required to be free from left venticular lead related complications at 3 months.|||5|
73808320|NCT03937908|147166213|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.16|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.16
73808321|NCT03937908|147166214|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.04|||||||t-test, 2 sided|||Asiatic acid||||0.04
73808322|NCT03937908|147166214|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.01|||||||t-test, 2 sided|||Caffeic acid||||0.01
73808323|NCT03937908|147166214|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.06|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.06
73808324|NCT03937908|147166214|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.08|||||||t-test, 2 sided|||Dihydroferulic acid||||0.08
73808325|NCT03937908|147166214|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.56|||||||t-test, 2 sided|||Dicaffeoylquinic acids||||0.56
73808326|NCT03937908|147166214|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.21|||||||t-test, 2 sided|||Ferulic acid||||0.21
73808327|NCT03937908|147166214|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.05
73808328|NCT03937908|147166214|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||Isoferulic acid||||0.05
73808329|NCT03937908|147166214|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Madecassic acid||||0.23
73808330|NCT03937908|147166214|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.16|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.16
73808331|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.7|||||||t-test, 2 sided|||Asiatic acid||||0.7
73808332|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.09|||||||t-test, 2 sided|||Madecassic acid||||0.09
73808333|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Asiaticoside||||0.4
73808334|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.6|||||||t-test, 2 sided|||Madecassoside||||0.6
73808335|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.4
73808336|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 2 sided|||Dicaffeoylquinic acids||||0.1
73808337|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.9|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.9
73808338|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.03|||||||t-test, 2 sided|||Caffeic acid||||0.03
73808339|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.9|||||||t-test, 2 sided|||Ferulic acid||||0.9
73808340|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.6|||||||t-test, 2 sided|||Isoferulic acid||||0.6
73808341|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Dihydroferulic acid||||0.4
73808342|NCT03937908|147166215|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.8|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.8
73808343|NCT03937908|147166216|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 1 sided|||1 hour||||0.1
73808344|NCT03937908|147166216|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 1 sided|||2 hours||||0.1
73808345|NCT03937908|147166216|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.3|||||||t-test, 1 sided|||3 hours||||0.3
73808346|NCT03937908|147166216|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.5|||||||t-test, 1 sided|||4 hours||||0.5
73808347|NCT03937908|147166216|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.5|||||||t-test, 1 sided|||6 hours||||0.5
73808348|NCT02991729|147166321|NON_INFERIORITY|The non-inferiority limit was 1 point on the questionnaire scale.||||||0.929||||||a priori threshold for statistical significance was p\<0.05.|Wilcoxon rank-sum|||||||0.929
73808349|NCT02991729|147166322|SUPERIORITY|||||||0.369|||||||Wilcoxon rank-sum|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion but prior to genetic counseling (first row, second column in above table).||||0.369
73808350|NCT02991729|147166322|SUPERIORITY|||||||0.003|||||||Wilcoxon rank-sum|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion and genetic counseling (second row, second column in above table).||||0.003
73808351|NCT02991729|147166322|SUPERIORITY|||||||0.003|||||||Wilcoxon signed-rank|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict pre-genetic counseling/post-decision aid to post-genetic counseling.||||0.003
73808352|NCT01154296|147166325|SUPERIORITY_OR_OTHER||adjusted risk ratio (aRR)|1.12|||||TWO_SIDED|95.0|0.94|1.33||In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.|Mantel Haenszel|||A total of 2039/2505 participants randomized to the counseling group and 2032/2507 to the information-only group had complete follow-up STI data. Cumulative STI incidence was 250/2039 (12.3%) in the counseling group and 226/2032 (11.1%) in the information-only group (aRR, 1.12; 95%CI, 0.94-1.33).||1.33|0.94|
73895877|NCT00763698|147325282|SUPERIORITY_OR_OTHER||Objective Performance Criteria|80.0|||||ONE_SIDED|97.5|2.5||||Wilson score interval method||||||2.5|
73895878|NCT01960907|147325292|SUPERIORITY_OR_OTHER|||||||0.342|||||||Log Rank|||||||0.342
73895879|NCT01960907|147325293|SUPERIORITY_OR_OTHER|||||||0.915|||||||t-test, 2 sided|||||||0.915
73895880|NCT01960907|147325294|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||||||0.038
73808353|NCT01154296|147166326|SUPERIORITY_OR_OTHER||Incidence rate ratio (IRR)|0.99|||||TWO_SIDED|95.0|0.9|1.09|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.09|0.90|
73808354|NCT01154296|147166327|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.98|||||TWO_SIDED|95.0|0.86|1.13|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.13|0.86|
73808355|NCT01154296|147166328|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.88|||||TWO_SIDED|95.0|0.82|0.94|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||0.94|0.82|
73808356|NCT01154296|147166329|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.97|||||TWO_SIDED|95.0|0.9|1.05|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.05|0.90|
73808357|NCT01154296|147166330|SUPERIORITY_OR_OTHER||Adjusted Risk Ratio (aRR)|1.14||||||95.0|0.89|1.46||In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.|Mantel Haenszel|||||1.46|0.89|
73808358|NCT02759055|147166331|SUPERIORITY||Risk Ratio (RR)|1.003|||<|0.05|TWO_SIDED|95.0|0.998|1.008|||Mixed Models Analysis|||||1.008|0.998|<0.05
73808359|NCT02877095|147166332|OTHER|||||||||||||||||All subjects on study received active drug.|Total count of events is provided.|||
73808360|NCT03692325|147166360|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
73808361|NCT02461524|147166369|OTHER||Percentage|2.9|||<|0.001|ONE_SIDED|97.5||8.7|||Exact binomial test|||"The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a Major Adverse Event (MAE) within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system and 20% is the safety PG."||8.7||<0.001
73895881|NCT00475982|147325337|SUPERIORITY||Mean Difference (Final Values)|0.965||||0.965|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.965
73895882|NCT00475982|147325338|SUPERIORITY||Mean Difference (Final Values)|0.884||||0.884|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.884
73808362|NCT02461524|147166370|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Percentage|100.0||||0.001|ONE_SIDED|95.0|95.8||||Based on exact binomial distribution|||"The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG."|||95.8|0.001
73808363|NCT00765895|147166391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||Mantel Haenszel|Stratified by clinic||||||0.86
73808364|NCT00748189|147166473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.45|0.72|||Log Rank||Hazard ratios are obtained using the Pike estimator.|||0.72|0.45|<0.001
73808365|NCT00748189|147166476|OTHER||Hazard Ratio (HR)|0.88||||0.363|TWO_SIDED|95.0|0.65|1.17|||Log Rank||hazard ratios are obtained using the Pike estimator. A hazard ratio \<1 indicates a lower risk with O+CHL treatment compared with chlorambucil|||1.17|0.65|0.363
73808366|NCT00748189|147166489|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.71|||||TWO_SIDED|90.0|0.53|0.94|||||Ratio of Cmax/Dose is the ratio of dose-normalized chlorambucil Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||0.94|0.53|
73895883|NCT00475982|147325339|SUPERIORITY|||||||0.294|||||||paired t-test|||intra-analysis within the weight loss arm||||0.294
73895884|NCT00475982|147325339|SUPERIORITY|||||||0.44|||||||paired t-test|||intra-analysis within the control arm||||0.440
73895885|NCT00475982|147325339|SUPERIORITY||Mean Difference (Net)|8.49||||0.186|TWO_SIDED|95.0|-4.31|21.3|||paired t-test|||analysis between the weight loss and control arms||21.3|-4.31|0.186
73895886|NCT00475982|147325340|SUPERIORITY|||||||0.162|||||||paired t-test|||intra-analysis within the weight loss arm||||0.162
73895887|NCT00475982|147325340|SUPERIORITY|||||||0.986|||||||paired t-test|||intra-analysis within the control arm||||0.986
73895888|NCT00475982|147325340|SUPERIORITY||Mean Difference (Net)|2.22||||0.353|TWO_SIDED|95.0|-2.58|7.02|||paired t-test|||analysis between the weight loss and control arms||7.02|-2.58|0.353
73895889|NCT00475982|147325341|SUPERIORITY|||||||0.283|||||||paired t-test|||intra-analysis within the weight loss arm||||0.283
73895890|NCT00475982|147325341|SUPERIORITY|||||||0.701|||||||paired t-test|||intra-analysis within the control arm||||0.701
73808367|NCT00748189|147166489|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized PAAM Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.79|||||TWO_SIDED|90.0|0.63|0.99|||||Ratio of Cmax/Dose is the ratio of dose-normalized PAAM Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||0.99|0.63|
73808368|NCT00748189|147166490|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|1.04|||||TWO_SIDED|90.0|0.77|1.4|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized chlorambucil AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.40|0.77|
73808369|NCT00748189|147166490|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil AUC(0-inf) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-inf)/Dose|1.11|||||TWO_SIDED|90.0|0.82|1.5|||||Ratio of AUC(0-inf)/Dose is the ratio of dose-normalized chlorambucil AUC(0-inf) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.50|0.82|
73808370|NCT00748189|147166490|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized PAAM AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|0.89|||||TWO_SIDED|90.0|0.72|1.1|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized PAAM AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.10|0.72|
73808371|NCT03320850|147166498|SUPERIORITY||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.635||0.0845|TWO_SIDED|95.0|-0.15|2.35|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.35|-0.15|0.0845
73808372|NCT03320850|147166498|SUPERIORITY||Least Squares Mean Difference|1.83|STANDARD_ERROR_OF_MEAN|0.633||0.0041|TWO_SIDED|95.0|0.59|3.08|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||3.08|0.59|0.0041
73808373|NCT03320850|147166498|SUPERIORITY||Least Squares Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|0.632||0.06|TWO_SIDED|95.0|-0.05|2.44|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.44|-0.05|0.0600
73808374|NCT03320850|147166498|SUPERIORITY||Least Squares Mean Difference|0.87|STANDARD_ERROR_OF_MEAN|0.631||0.1702|TWO_SIDED|95.0|-0.37|2.11|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.11|-0.37|0.1702
73808375|NCT03320850|147166500|SUPERIORITY||Least Square Mean|0.73|STANDARD_ERROR_OF_MEAN|0.617||0.2361|TWO_SIDED|95.0|-0.48|1.95|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.95|-0.48|0.2361
73808376|NCT03320850|147166500|SUPERIORITY||Least Square Mean|0.78|STANDARD_ERROR_OF_MEAN|0.608||0.1985|TWO_SIDED|95.0|-0.41|1.98|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.98|-0.41|0.1985
73808377|NCT03320850|147166500|SUPERIORITY||Least Square Mean|0.64|STANDARD_ERROR_OF_MEAN|0.607||0.2923|TWO_SIDED|95.0|-0.56|1.84|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.84|-0.56|0.2923
73808378|NCT03320850|147166500|SUPERIORITY||Least Square Mean|0.54|STANDARD_ERROR_OF_MEAN|0.609||0.3769|TWO_SIDED|95.0|-0.66|1.74|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.74|-0.66|0.3769
73895891|NCT00475982|147325341|SUPERIORITY||Mean Difference (Net)|0.77||||0.835|TWO_SIDED|95.0|-6.7|8.24|||paired t-test|||analysis between the intervention and control arms||8.24|-6.70|0.835
73895892|NCT00475982|147325342|SUPERIORITY|||||||0|||||||paired t-test|||intra-analysis within the weight loss arm||||0.00
73808379|NCT03320850|147166501|SUPERIORITY||Least Square Mean|-7.05|STANDARD_ERROR_OF_MEAN|13.107||0.5911|TWO_SIDED|95.0|-32.87|18.77|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||18.77|-32.87|0.5911
73808380|NCT03320850|147166501|SUPERIORITY||Least Square Mean|-8.0|STANDARD_ERROR_OF_MEAN|12.956||0.5375|TWO_SIDED|95.0|-33.52|17.52|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||17.52|-33.52|0.5375
73808381|NCT03320850|147166501|SUPERIORITY||Least Square Mean|-1.33|STANDARD_ERROR_OF_MEAN|12.764||0.9173|TWO_SIDED|95.0|-26.47|23.81|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||23.81|-26.47|0.9173
73895893|NCT00475982|147325342|SUPERIORITY|||||||0.009|||||||paired t-test|||intra-analysis within the control arm||||0.009
73895894|NCT00475982|147325342|SUPERIORITY||Mean Difference (Net)|2.11||||0.007|TWO_SIDED|95.0|0.64|3.59|||paired t-test|||analysis between the two arms||3.59|0.64|0.007
73895895|NCT00475982|147325343|SUPERIORITY|||||||0.073|||||||paired t-test|||intra-analysis within the weight loss arm||||0.073
73808382|NCT03320850|147166501|SUPERIORITY||Least Square Mean|9.33|STANDARD_ERROR_OF_MEAN|12.981||0.473|TWO_SIDED|95.0|-16.24|34.9|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||34.90|-16.24|0.4730
73808383|NCT04481191|147166502|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-4.0|0.9||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use Group % - Staggered-use Group %||0.9|-4.0|< 0.001
73808384|NCT04481191|147166502|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-4.3|1.5||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use Group % - Staggered-use Group %||1.5|-4.3|< 0.001
73808385|NCT04481191|147166502|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|-1.6|3.0||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use % - Staggered-use %||3.0|-1.6|< 0.001
73808386|NCT01424514|147166514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.6|0.36||||||Placebo vs SB-705498 12 mg for 1 h in WM 0-60 TSS||0.36|-0.60|
73808387|NCT01424514|147166514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.45|0.51||||||Placebo vs SB-705498 12 mg for 24 h in WM 0-60 TSS||0.51|-0.45|
73808388|NCT01424514|147166514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.58|0.51||||||Placebo vs SB-705498 12 mg for 1 h in Maximum TSS||0.51|-0.58|
73808389|NCT01424514|147166514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.51|0.72||||||Placebo vs SB-705498 12 mg for 24 h in Maximum TSS||0.72|-0.51|
73808390|NCT01424514|147166516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.3|0.54||||||Placebo vs SB-705498 12 mg for WM 0-60 TSS||0.54|-0.30|
73808391|NCT01424514|147166516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.39|0.57||||||Placebo vs SB-705498 12 mg for Maximum TSS||0.57|-0.39|
73808392|NCT01424514|147166520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.14|0.08||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 sneezing||0.08|-0.14|
73895896|NCT00475982|147325343|SUPERIORITY|||||||0.207|||||||paired t-test|||intra-analysis within the control arm||||0.207
73808393|NCT01424514|147166520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.13|0.09||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 sneezing||0.09|-0.13|
73895897|NCT00475982|147325343|SUPERIORITY||Mean Difference (Net)|1.34||||0.063|TWO_SIDED|95.0|-0.08|2.75|||paired t-test|||analysis between the two arms||2.75|-0.08|0.063
73895898|NCT00783198|147325352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76||||0.0039|TWO_SIDED|95.0|-2.95|-0.57|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.57|-2.95|0.0039
73895899|NCT00783198|147325352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.24||||0.0002|TWO_SIDED|95.0|-3.41|-1.07|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-1.07|-3.41|0.0002
73808394|NCT01424514|147166520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.2|0.11||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 sneezing||0.11|-0.20|
73808395|NCT01424514|147166520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.28|0.14||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum sneezing||0.14|-0.28|
73808396|NCT01424514|147166520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.15|0.13||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum sneezing||0.13|-0.15|
73808397|NCT01424514|147166520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.16||||||Placebo vs SB-705498 12 mg for Day 1, 24 h in Maximum sneezing||0.16|-0.20|
73808398|NCT01424514|147166521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.026|||TWO_SIDED|95.0|-0.03|0.07||||||Placebo vs SB-705498 12 mg for Day 1, 2 h in AR||0.07|-0.03|
73808399|NCT01424514|147166521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|-0.13|-0.02||||||Placebo vs SB-705498 12 mg for Day 14, 2 h in AR||-0.02|-0.13|
73808400|NCT01424514|147166521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.04|0.08||||||Placebo vs SB-705498 12 mg for Day 14, 25 h in AR||0.08|-0.04|
73808401|NCT01424514|147166522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.36|0.26||||||Placebo vs SB-705498 12 mg for Day 14 in AR||0.26|-0.36|
73808402|NCT01424514|147166523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.06|0.6||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 TOSS||0.60|-0.06|
73808403|NCT01424514|147166523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.32|0.53||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 TOSS||0.53|-0.32|
73808404|NCT01424514|147166523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.22|0.63||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 TOSS||0.63|-0.22|
73808405|NCT01424514|147166523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.3|0.68||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum TOSS||0.68|-0.30|
73808406|NCT01424514|147166523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.34|0.86||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum TOSS||0.86|-0.34|
73808407|NCT01424514|147166523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.15|0.73||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in Maximum TOSS||0.73|-0.15|
73808408|NCT02653170|147166613|SUPERIORITY||difference-in-differences (DID) p-value|0.025||||0.025|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = 0.970 (p=0.335), SWSCM+VSSP vs Usual Care = 3.370 (p\<0.001), SWSCM+VSSP vs SWSCM = 2.400 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.025
73808409|NCT02653170|147166614|SUPERIORITY||difference-in-differences (DID) p-value|0.562||||0.562|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.064 (p=0.422), SWSCM+VSSP vs Usual Care = 0.258 (p=0.844), SWSCM+VSSP vs SWSCM = 1.322 (p=0.309)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.562
73808410|NCT02653170|147166615|SUPERIORITY|||||||0.789||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.789
73808411|NCT02653170|147166616|SUPERIORITY||difference-in-differences (DID) p-value|0.042||||0.042|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis||The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.651 (p=0.558), SWSCM+VSSP vs Usual Care = 5.023 (p=0.073), SWSCM+VSSP vs SWSCM = 6.674 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.042
73808412|NCT02653170|147166617|SUPERIORITY|||||||0.993||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.993
73808413|NCT04984278|147166637|SUPERIORITY||Combined least mean square difference|-0.29|STANDARD_ERROR_OF_MEAN|0.092|=|0.0048|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|||||-0.10|-0.48|=0.0048
73808414|NCT04304235|147166654|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|||||||||||||
73808415|NCT00425061|147166659|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-5.2||||0.612|TWO_SIDED|95.0|-25.6|15.2|||ANCOVA|||Day 112: Analysis of co-variance (ANCOVA) model was used with baseline as a covariate, long-acting beta-agonist (LABA) use (Inhaled Corticosteroid \[ICS\] only or ICS plus LABA) and treatment as two factors.||15.2|-25.6|0.612
73808416|NCT00425061|147166661|SUPERIORITY_OR_OTHER||LS mean Difference|0.0||||0.482|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.482
73808417|NCT00425061|147166661|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.492|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.492
73808418|NCT00425061|147166661|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.323|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.323
73808419|NCT00425061|147166661|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.226|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.226
73808420|NCT00425061|147166661|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.256|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.256
73808421|NCT00425061|147166662|SUPERIORITY_OR_OTHER||LS mean difference|1.8||||0.09|TWO_SIDED|95.0|-0.3|3.9|||ANCOVA|||Day 28: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||3.9|-0.3|0.090
73808422|NCT00425061|147166662|SUPERIORITY_OR_OTHER||LS mean difference|2.1||||0.144|TWO_SIDED|95.0|-0.8|5.0|||ANCOVA|||Day 112: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||5.0|-0.8|0.144
73808423|NCT00425061|147166664|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.354|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.4|0.354
73808424|NCT00425061|147166664|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.9|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.4|-0.4|0.900
73808425|NCT00425061|147166664|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.921|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.4|-0.4|0.921
73808426|NCT00425061|147166664|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.388|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.6|-0.2|0.388
73808427|NCT00425061|147166664|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.249|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.7|-0.2|0.249
73895900|NCT00783198|147325353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.032|TWO_SIDED|95.0|-2.08|-0.09|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.09|-2.08|0.0320
73895901|NCT00783198|147325353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.0003|TWO_SIDED|95.0|-2.78|-0.82|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.82|-2.78|0.0003
73808428|NCT00425061|147166665|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||Chi-squared|||||||0.267
73808429|NCT00425061|147166666|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Chi-squared|||||||0.029
73808430|NCT00090220|147166697|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|88.7||||||95.0|78.1|94.8|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||94.8|78.1|
73808431|NCT00090220|147166723|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|94.8||||||95.0|79.9|99.4|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||99.4|79.9|
73808432|NCT00090220|147166731|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|84.7||||||95.0|67.5|93.7|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||93.7|67.5|
73808433|NCT00537316|147166749|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||Chi-squared|||||||0.032
73808434|NCT02651155|147166755|SUPERIORITY_OR_OTHER||Median Values of CI|1.0||||0.003|TWO_SIDED|95.0|0.1|1.0|||Van Elteren Test|SBM was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|CI was estimated by inverting the hypothesis test.|||1.0|0.1|0.003
73808435|NCT00507819|147166770|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Regression, Linear|||||||0.73
73808436|NCT00507819|147166771|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Regression, Linear|||||||0.37
73895902|NCT00783198|147325354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.0472|TWO_SIDED|95.0|-1.54|-0.01|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.01|-1.54|0.0472
73895903|NCT00783198|147325354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0144|TWO_SIDED|95.0|-1.7|-0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.19|-1.70|0.0144
73808437|NCT00507819|147166772|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
73808438|NCT00507819|147166773|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Linear|||||||0.04
73808439|NCT01098500|147166774|SUPERIORITY_OR_OTHER||Prevalence percentage|2.2|||||TWO_SIDED|95.0|0.9|3.5|||||Prevalence percentage is the number of patients with an ALT \>=3 times ULN divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).|||3.5|0.9|
73808440|NCT01098500|147166775|SUPERIORITY_OR_OTHER||Incidence Rate (IR)|6.2|||||TWO_SIDED|95.0|3.3|9.0|||||Incidence rate (IR) is the number of patients with an ALT \>=3 times ULN after initiation of TKI divided by person time contributed by all patients with normal ALT (\<1 times ULN) at baseline. IR expressed per 100 person years.|||9.0|3.3|
73808441|NCT01098500|147166776|SUPERIORITY_OR_OTHER||Prevalence percentage|0.4|||||TWO_SIDED|95.0|0.1|1.4|||||Prevalence percentage is the number of patients with Hy's Law divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).|||1.4|0.1|
73808442|NCT01098500|147166777|SUPERIORITY_OR_OTHER||Incidence Rate (IR)|0.4|||||TWO_SIDED|95.0|0.0|2.0|||||Incidence rate (IR) is the number of patients with Hy's Law after initiation of TKI divided by person time contributed by all patients with normal ALT, AST, ALP, and BIL (\< 1 times ULN) at baseline. IR is expressed per 100 person years.|||2.0|0.0|
73808443|NCT03452488|147166786|SUPERIORITY|||||||0.2437|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic.||||0.2437
73895904|NCT00783198|147325355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.1686|TWO_SIDED|95.0|-1.11|0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.19|-1.11|0.1686
73895905|NCT00783198|147325355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0125|TWO_SIDED|95.0|-1.46|-0.18|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.18|-1.46|0.0125
73895906|NCT00783198|147325356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.0039|TWO_SIDED|95.0|-1.65|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.65|0.0039
73808444|NCT03452488|147166786|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic||||0.2000
73808445|NCT03452488|147166786|SUPERIORITY|||||||0.324|TWO_SIDED|95.0|||||Adjusted Bayesian Imputation|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on adjusted Bayesian Imputation||||0.3240
73808446|NCT03452488|147166786|SUPERIORITY|Gait Speed Based on Adjusted Bayesian Imputation||||||0.5123|||||||Adjusted Bayesian Imputation|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on adjusted Bayesian Imputation||||0.5123
73808447|NCT03452488|147166786|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on MI and Adjusted Bayesian Imputation||||0.6920
73808448|NCT03452488|147166786|SUPERIORITY|||||||0.085|TWO_SIDED|95.0|||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on MI and Adjusted Bayesian Imputation||||0.0850
73808449|NCT03452488|147166787|SUPERIORITY|||||||0.9408|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-score based on Mixed Model Analysis||||0.9408
73808450|NCT03452488|147166787|SUPERIORITY|||||||0.9485|TWO_SIDED|95.0|||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-score based on Mixed Model Analysis||||0.9485
73808451|NCT03452488|147166787|SUPERIORITY|||||||0.9848|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-Score Based on Adjusted Bayesian Imputation||||0.9848
73808452|NCT03452488|147166787|SUPERIORITY|||||||0.5017|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-Score Based on Adjusted Bayesian Imputation||||0.5017
73808453|NCT03452488|147166788|SUPERIORITY|||||||0.52|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (dominant hand)||||0.5200
73808454|NCT03452488|147166788|SUPERIORITY|||||||0.3577|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (dominant hand)||||0.3577
73808455|NCT03452488|147166788|SUPERIORITY|||||||0.9237|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test at Month 6 Based on Multiple Imputation (dominant hand)||||0.9237
73808456|NCT03452488|147166788|SUPERIORITY|||||||0.7629|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test at Month 6 Based on Multiple Imputation (dominant hand)||||0.7629
73808457|NCT03452488|147166788|SUPERIORITY|||||||0.5695|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Change from Baseline in Handgrip Strength Test (left hand)||||0.5695
73808458|NCT03452488|147166788|SUPERIORITY|||||||0.3523|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Left hand)||||0.3523
73808459|NCT03452488|147166788|SUPERIORITY|||||||0.5652|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Right hand)||||0.5652
73808460|NCT03452488|147166788|SUPERIORITY|||||||0.2472|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Right hand)||||0.2472
73808461|NCT03452488|147166789|SUPERIORITY|||||||0.9859||||||Statistical Analysis of Change from Baseline in ALM|ANCOVA|||||||0.9859
73808462|NCT03452488|147166789|SUPERIORITY|||||||0.404|||||||ANCOVA|||Statistical Analysis of Change from Baseline in ALM||||0.4040
73808463|NCT03452488|147166790|SUPERIORITY|||||||0.1219|||||||Regression, Logistic|||||||0.1219
73808464|NCT03452488|147166790|SUPERIORITY|||||||0.052|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.0520
73808465|NCT03452488|147166791|SUPERIORITY|||||||0.8917|||||||ANCOVA|||||||0.8917
73808466|NCT03452488|147166791|SUPERIORITY||Mean Difference (Final Values)|-4.999|STANDARD_ERROR_OF_MEAN|10.2172||0.6317|TWO_SIDED|95.0|-26.777|16.778|||ANCOVA|||||16.778|-26.777|0.6317
73808467|NCT03452488|147166792|SUPERIORITY|||||||0.3762|||||||Mixed Models Analysis|||||||0.3762
73808468|NCT03452488|147166792|SUPERIORITY|||||||0.0543|||||||Mixed Models Analysis|||||||0.0543
73808469|NCT03452488|147166793|SUPERIORITY|||||||0.8824|||||||ANCOVA|||||||0.8824
73808470|NCT03452488|147166793|SUPERIORITY|||||||0.1578|||||||ANCOVA|||||||0.1578
73808471|NCT03452488|147166794|SUPERIORITY|||||||0.0511|||||||ANCOVA|||||||0.0511
73808472|NCT03452488|147166794|SUPERIORITY|||||||0.2771|||||||ANCOVA|||||||0.2771
73808473|NCT03452488|147166795|SUPERIORITY|||||||0.8084|||||||Mixed Models Analysis|||||||0.8084
73808474|NCT03452488|147166795|SUPERIORITY|||||||0.7266|||||||Mixed Models Analysis|||||||0.7266
73808475|NCT03452488|147166796|SUPERIORITY|||||||0.2312|||||||Mixed Models Analysis|||||||0.2312
73808476|NCT03452488|147166796|SUPERIORITY|||||||0.2701|||||||Mixed Models Analysis|||||||0.2701
73808477|NCT03452488|147166797|SUPERIORITY|||||||0.8934|||||||ANCOVA|||||||0.8934
73808478|NCT03452488|147166797|SUPERIORITY|||||||0.3526|||||||ANCOVA|||||||0.3526
73808479|NCT00288600|147166850|SUPERIORITY_OR_OTHER|||||||0.765|TWO_SIDED||||||Chi-squared, Corrected|||Need of Exchange transfusion following the AAP criteria||||0.765
73808480|NCT03226769|147166865|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.9788||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Computer Usage||||0.9788
73808481|NCT03226769|147166865|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.6571||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Reading||||0.6571
73808482|NCT03226769|147166865|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.471||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Leisure Activities||||0.4710
73808483|NCT03226769|147166865|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.736||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Social Activities||||0.7360
73808484|NCT03226769|147166865|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4999||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Driving||||0.4999
73808485|NCT03226769|147166865|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1159||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Outdoor Activities||||0.1159
73808486|NCT03226769|147166865|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4567||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Frequency of Outdoor Activities||||0.4567
73808487|NCT03226769|147166865|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3439||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Time Spent to Take Care of Eyes||||0.3439
73808488|NCT03226769|147166865|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3331||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Bothered With Amount of Time Taking Care of Eyes||||0.3331
73808489|NCT03226769|147166865|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4774||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Bothered by Appearance||||0.4774
73808490|NCT03226769|147166866|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.5457||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Red Eyes||||0.5457
73808491|NCT03226769|147166866|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.9786||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Blurred Vision||||0.9786
73808492|NCT03226769|147166866|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3894||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Dry Eyes||||0.3894
73808493|NCT03226769|147166866|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.0591||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Itchy Eyes||||0.0591
73808494|NCT03226769|147166866|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1818||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Burning Eyes||||0.1818
73808495|NCT03226769|147166866|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4284||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Gritty Eyes||||0.4284
73808496|NCT03226769|147166866|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1051||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Painful Eyes||||0.1051
73808497|NCT03226769|147166866|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.7998||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Watery Eyes||||0.7998
73808498|NCT03226769|147166866|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1229||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Swollen Eyelids||||0.1229
73808499|NCT03226769|147166866|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3907||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Red Eyelids||||0.3907
73808500|NCT03226769|147166866|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.0336||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Crusty Eyelids||||0.0336
73808501|NCT05270395|147166908|SUPERIORITY||Odds Ratio (OR)|8.02||||0.02|TWO_SIDED|95.0|1.38|46.69|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||46.69|1.38|0.02
73808502|NCT05270395|147166909|SUPERIORITY||Odds Ratio (OR)|1.35||||0.63|TWO_SIDED|95.0|0.4|4.56|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||4.56|0.40|0.63
73808503|NCT05270395|147166910|SUPERIORITY||Odds Ratio (OR)|0.29||||0.13|TWO_SIDED|95.0|0.06|1.46|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||1.46|0.06|0.13
73808504|NCT05270395|147166911|SUPERIORITY||Odds Ratio (OR)|0.54||||0.4|TWO_SIDED|95.0|0.13|2.24|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||2.24|0.13|0.40
73895907|NCT00783198|147325356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0001|TWO_SIDED|95.0|-1.95|-0.64|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.64|-1.95|0.0001
73808505|NCT05270395|147166912|SUPERIORITY||Odds Ratio (OR)|2.22||||0.29|TWO_SIDED|95.0|0.51|9.62|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||9.62|0.51|0.29
73808506|NCT05270395|147166913|SUPERIORITY||Odds Ratio (OR)|3.55||||0.07|TWO_SIDED|95.0|0.88|14.32|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||14.32|0.88|0.07
73808507|NCT05270395|147166914|SUPERIORITY||Odds Ratio (OR)|3.93||||0.09|TWO_SIDED|95.0|0.82|18.89|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||18.89|0.82|0.09
73808508|NCT05270395|147166915|SUPERIORITY||Odds Ratio (OR)|1.73||||0.42|TWO_SIDED|95.0|0.46|6.43|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||6.43|0.46|0.42
73808509|NCT05270395|147166916|SUPERIORITY||Odds Ratio (OR)|2.86||||0.08|TWO_SIDED|95.0|0.87|9.42|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||9.42|0.87|0.08
73808510|NCT05270395|147166917|SUPERIORITY||Odds Ratio (OR)|8.29||||0.004|TWO_SIDED|95.0|1.99|34.49|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||34.49|1.99|0.004
73808511|NCT00784550|147166958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73808512|NCT00784550|147166959|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73808513|NCT00784550|147166960|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
73808514|NCT00784550|147166961|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73808515|NCT00784550|147166962|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73808516|NCT00784550|147166963|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Mastery domain|ANCOVA|||||||0.069
73808517|NCT00784550|147166963|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||Fatigue domain|ANCOVA|||||||0.470
73808518|NCT00784550|147166963|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||Emotional function domain|ANCOVA|||||||0.394
73808519|NCT00784550|147166963|SUPERIORITY_OR_OTHER|||||||0.879||95.0|||||ANCOVA|Dyspnea domain||||||0.879
73808520|NCT00688701|147166964|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.123|<|0.0001|TWO_SIDED|95.0|-0.785|-0.3||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.300|-0.785|<0.0001
73808521|NCT00688701|147166964|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-0.903|-0.423||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.423|-0.903|<0.0001
73808522|NCT03875092|147166989|OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.24|0.52|||||Based on unstratified Cox regression model with treatment as a covariate, due to small sample size.|||0.52|0.24|
73808523|NCT03875092|147166990|OTHER||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.28|0.7|||||Based on unstratified Cox regression model with treatment as a covariate, due to small sample size.|||0.70|0.28|
73808524|NCT03875092|147166991|OTHER||Difference in Percentage|36.7|||||TWO_SIDED|95.0|19.9|51.6|||||Based on unstratified Miettinen \& Nurminen method, due to small sample size.|||51.6|19.9|
73808525|NCT02163226|147167007|OTHER|2 sided p value||||||0.03|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 2 weeks||||.03
73808526|NCT02163226|147167007|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 1 month||||.19
73808527|NCT02163226|147167007|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 3 months||||.04
73808528|NCT02163226|147167007|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 6 months||||.89
73808529|NCT02163226|147167007|SUPERIORITY|||||||0.07|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 9 months||||.07
73808530|NCT02163226|147167007|OTHER|2 sided p value||||||0.03|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 2 weeks||||.03
73808531|NCT02163226|147167007|OTHER|2 sided p value||||||0.19|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 1 month||||.19
73808532|NCT02163226|147167007|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 3 months||||.04
73808533|NCT02163226|147167007|OTHER|2 sided p value||||||0.89|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 6 months||||.89
73808534|NCT02163226|147167007|OTHER|2 sided p value||||||0.07|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 9 months||||.07
73808535|NCT02163226|147167008|OTHER|2 sided p value||||||0.01|||||||Fisher Exact|||Pain response Rates (CR+PR) at 2 weeks||||.01
73808536|NCT02163226|147167008|OTHER|2 sided p value||||||0.15|||||||Fisher Exact|||Pain response Rates (CR+PR) at 1 month||||.15
73808537|NCT02163226|147167008|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 3 months||||.04
73808538|NCT02163226|147167008|OTHER|2 sided p valued||||||0.78|||||||Fisher Exact|||Pain response Rates (CR+PR) at 6 months||||.78
73808539|NCT02163226|147167008|OTHER|2 sided p valued||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 9 months||||.04
73808540|NCT02163226|147167008|OTHER|2 sided p valued||||||0.01|||||||Fisher Exact|||Pain response Rates (CR+PR) at 2 weeks||||.01
73808541|NCT02163226|147167008|OTHER|2 sided p value||||||0.15|||||||Fisher Exact|||Pain response Rates (CR+PR) at 1 month||||.15
73808542|NCT02163226|147167008|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 3 months||||.04
73808543|NCT02163226|147167008|OTHER|2 sided p value||||||0.78|||||||Fisher Exact|||Pain response Rates (CR+PR) at 6 months||||.78
73808544|NCT02163226|147167008|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 9 months||||.04
73808545|NCT00970632|147167085|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1||||0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tadalafil and placebo treatment groups was for the primary comparison and assessed for significance at a level of 0.05.|ANCOVA|||||||0.001
73808546|NCT00970632|147167085|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.023||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin and placebo treatment groups was secondary in nature and assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.023
73808547|NCT00970632|147167086|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||<0.001
73808548|NCT00970632|147167086|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
73808549|NCT00970632|147167087|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.055
73808550|NCT00970632|147167087|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.055
73808551|NCT00970632|147167088|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
73808552|NCT00970632|147167088|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.026||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.026
73808553|NCT00970632|147167089|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.08||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.080
73808554|NCT00970632|147167089|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.118||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.118
73808555|NCT00970632|147167090|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.022||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.022
73808556|NCT00970632|147167090|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.546||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.546
73808557|NCT00970632|147167091|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||0.003
73808558|NCT00970632|147167091|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.005||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.005
73808559|NCT00970632|147167092|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||<0.001
73808560|NCT00970632|147167092|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
73808561|NCT00970632|147167093|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||0.003
73808562|NCT00970632|147167093|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.026||95.0||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.026
73808563|NCT00970632|147167094|SUPERIORITY_OR_OTHER|||||||0.001||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.001
73808564|NCT00970632|147167094|SUPERIORITY_OR_OTHER|||||||0.114||95.0||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.114
73808565|NCT00970632|147167095|SUPERIORITY_OR_OTHER|||||||0.004||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and a stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.004
73808566|NCT00970632|147167095|SUPERIORITY_OR_OTHER|||||||0.452||||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.452
73808567|NCT00970632|147167096|SUPERIORITY_OR_OTHER||Median of Treatment Group Differences|-4.4||||0.005||||||The p-value associated with the testing for differences in medians between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.||||||0.005
73808568|NCT00970632|147167096|SUPERIORITY_OR_OTHER||Median of Treatment Group Differences|-2.2||||0.457||||||The p-value associated with the testing for differences in medians between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 without adjustments for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.||||||0.457
73808569|NCT00970632|147167097|SUPERIORITY_OR_OTHER||Difference in LS Means|4.0|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA|||||||<0.001
73808570|NCT00970632|147167097|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.699||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA|||||||0.699
73808571|NCT00970632|147167098|SUPERIORITY_OR_OTHER|||||||0.009||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.||||||0.009
73808572|NCT00970632|147167098|SUPERIORITY_OR_OTHER|||||||0.014||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.||||||0.014
73808573|NCT00970632|147167101|SUPERIORITY_OR_OTHER|||||||0.303||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.||||||0.303
73808574|NCT00970632|147167101|SUPERIORITY_OR_OTHER|||||||0.146||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.||||||0.146
73808575|NCT02002533|147167103|SUPERIORITY||||||>|0.9999|||||||exact binomial test|The percentage is greater than or equal to 40%.||||||>0.9999
73808576|NCT02002533|147167104|SUPERIORITY|||||||0.735|||||||exact binomial test|||||||0.7350
73808577|NCT02002533|147167105|SUPERIORITY||Mean Difference (Final Values)|0.8075|STANDARD_ERROR_OF_MEAN|0.0845|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
73808578|NCT02002533|147167106|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|1.21||0.1808|TWO_SIDED||||||ANCOVA||The estimated value is BBT minus HEAL.|||||0.1808
73808579|NCT02002533|147167107|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.73||0.14|TWO_SIDED||||||ANCOVA||Estimated value is BBT minus HEAL.|||||0.14
73808580|NCT02002533|147167108|SUPERIORITY||Mean Difference (Final Values)|0.404|STANDARD_ERROR_OF_MEAN|0.137||0.005|TWO_SIDED||||||ANCOVA|For baseline of 0.7.||||||0.005
73808581|NCT02002533|147167108|SUPERIORITY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.045||0.092|TWO_SIDED|||||At baseline 1.3.|ANCOVA|||||||0.092
73895908|NCT00791817|147325358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3897|||||TWO_SIDED|90.0|1.1998|1.6097||||Confidence Interval is on the Ratio of Fed to Fasted|Confidence Interval is on the Ratio of Fed to Fasted|values are Geometric Means and Confidence Intervals are on the Ratio of Fed to Fasted||1.6097|1.1998|
73808582|NCT02002533|147167108|SUPERIORITY||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.053||0.556|TWO_SIDED|||||At baseline of 1.5.|ANCOVA|||||||0.556
73808583|NCT02002533|147167108|SUPERIORITY||Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|0.221||0.007|TWO_SIDED|||||Grouped by baseline interaction.|ANCOVA||The estimated value is grouped by baseline interaction parameter.|||||0.007
73808584|NCT02002533|147167109|SUPERIORITY|||||||0|||||||ANCOVA|||||||0.000
73808585|NCT02002533|147167110|SUPERIORITY|||||||0.295|||||||ANCOVA|||||||0.295
73808586|NCT02002533|147167111|SUPERIORITY|||||||0.573|||||||ANCOVA|||||||0.573
73808587|NCT02002533|147167112|SUPERIORITY||Mean Difference (Final Values)|-6.502|STANDARD_ERROR_OF_MEAN|2.558||0.015|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.015
73808588|NCT02002533|147167112|SUPERIORITY||Mean Difference (Final Values)|-1.723|STANDARD_ERROR_OF_MEAN|1.007||0.094|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.094
73808589|NCT02002533|147167112|SUPERIORITY||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|2.326||0.114|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.114
73808590|NCT02002533|147167112|SUPERIORITY||Mean Difference (Final Values)|0.911|STANDARD_ERROR_OF_MEAN|0.4||0.027|TWO_SIDED||||||ANCOVA||This is an arm by baseline interaction parameter.|||||0.027
73808591|NCT03628339|147167197|OTHER||% Ratio of Geometric Least square Mean|101.4|||||TWO_SIDED|90.0|89.35|115.06||||||||115.06|89.35|
73808592|NCT03628339|147167198|OTHER||% Ratio of Geometric Least square Mean|101.16|||||TWO_SIDED|90.0|89.24|114.66||||||||114.66|89.24|
73808593|NCT03628339|147167199|OTHER||% Ratio of Geometric Least square Mean|103.62|||||TWO_SIDED|90.0|86.91|123.56||||||||123.56|86.91|
73808594|NCT03886519|147167243|SUPERIORITY||Odds Ratio (OR)|0.73||||0.07|TWO_SIDED|95.0|0.52|1.03||The a priori threshold for statistical significance is \<0.05.|Regression, Logistic|Adjusted for correlation between 2 eyes of a participant and baseline trichiasis severity.||||1.03|0.52|0.07
73808595|NCT01023256|147167279|SUPERIORITY_OR_OTHER|||||||0.095||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.095
73808596|NCT01023256|147167279|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||<0.0001
73895909|NCT04784442|147325363|SUPERIORITY|The overall Type I error rate will be controlled by performing comparison versus the placebo group starting from the highest ETC 1002 dose group by a closed testing procedure at a two-sided significance level of 0.05.|Least squares mean difference|-19.35|STANDARD_ERROR_OF_MEAN|2.768|<|0.001|TWO_SIDED|95.0|-24.81|-13.88|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.88|-24.81|<0.001
73895910|NCT04784442|147325363|SUPERIORITY||Least squares mean difference|-19.93|STANDARD_ERROR_OF_MEAN|2.798|<|0.001|TWO_SIDED|95.0|-25.45|-14.41|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 120 mg arm minus the value for the placebo arm.|||-14.41|-25.45|<0.001
73895911|NCT04784442|147325363|SUPERIORITY||Least squares mean difference|-8.67|STANDARD_ERROR_OF_MEAN|2.813||0.002|TWO_SIDED|95.0|-14.22|-3.12|||ANCOVA||||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|-3.12|-14.22|0.002
73895912|NCT04525885|147325385|SUPERIORITY|Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|Estimated Relative Reduction (%)|8.7||||0.713|TWO_SIDED|95.0|-30.51|70.03|||ANCOVA||Estimated relative reduction (ERR) relative to placebo was calculated by 100 (e\*\*DIFF -1), where e\*\*DIFF=exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.|||70.03|-30.51|0.713
73808597|NCT01023256|147167279|SUPERIORITY_OR_OTHER|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.003
73808598|NCT01023256|147167281|SUPERIORITY_OR_OTHER|||||||0.421||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.421
73808599|NCT01023256|147167281|SUPERIORITY_OR_OTHER|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.003
73808600|NCT01023256|147167281|SUPERIORITY_OR_OTHER|||||||0.065||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.065
73808601|NCT01023256|147167282|SUPERIORITY_OR_OTHER|||||||0.243||||||P values \<0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included||||||0.243
73808602|NCT01023256|147167282|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P values \< 0.05 were considered significant.|Fisher Exact|Patients with missing values were not included||||||<0.0001
73808603|NCT01023256|147167282|SUPERIORITY_OR_OTHER|||||||0.135||||||P values \<0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included.||||||0.135
73808604|NCT03155178|147167286|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.13|TWO_SIDED|95.0|-0.53|0.07|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment."||0.07|-0.53|0.13
73808605|NCT03155178|147167286|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.78|TWO_SIDED|95.0|-0.23|0.3|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment."||0.30|-0.23|0.78
73808606|NCT03155178|147167286|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.17||0.77|TWO_SIDED|95.0|-0.38|0.29|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment."||0.29|-0.38|0.77
73808607|NCT03155178|147167286|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.15||0.37|TWO_SIDED|95.0|-0.45|0.17|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment."||0.17|-0.45|0.37
73808608|NCT03155178|147167286|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.2|0.58|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment."||0.58|-0.20|0.33
73808609|NCT03155178|147167286|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.16||0.65|TWO_SIDED|95.0|-0.25|0.39|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment."||0.39|-0.25|0.65
73808610|NCT03155178|147167287|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.22||0.38|TWO_SIDED|95.0|-0.63|0.24|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."||0.24|-0.63|0.38
73808611|NCT03155178|147167287|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.68|TWO_SIDED|95.0|-0.3|0.45|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."||0.45|-0.30|0.68
73808612|NCT03155178|147167287|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.23||0.97|TWO_SIDED|95.0|-0.47|0.45|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."||0.45|-0.47|0.97
73808613|NCT03155178|147167287|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.23||0.4|TWO_SIDED|95.0|-0.27|0.65|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."||0.65|-0.27|0.40
73808614|NCT03155178|147167287|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.25||0.03|TWO_SIDED|95.0|0.05|1.03||Using a Hochberg Step-up procedure the critical p value is 0.17|Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."||1.03|0.05|0.03
73808615|NCT03155178|147167287|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.23||0.07|TWO_SIDED|95.0|-0.03|0.87|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."||0.87|-0.03|0.07
73895913|NCT04525885|147325388|SUPERIORITY||Estimated Relative Reduction (%)|11.58||||0.628|TWO_SIDED|95.0|-28.68|74.57||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA||Estimated relative reduction (ERR) relative to placebo was calculated by 100 (e\*\*DIFF -1), where e\*\*DIFF=exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.|||74.57|-28.68|0.628
73895914|NCT04525885|147325389|SUPERIORITY||Odds Ratio (OR)|0.96||||0.917|TWO_SIDED|95.0|0.43|2.13||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||2.13|0.43|0.917
73895915|NCT04525885|147325390|SUPERIORITY||Odds Ratio (OR)|0.85||||0.687|TWO_SIDED|95.0|0.38|1.88||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour by visit as covariates.|Regression, Logistic|||||1.88|0.38|0.687
73895916|NCT04525885|147325391|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.49|2.49||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly CSD total score and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.49|0.49|
73895917|NCT04525885|147325392|OTHER||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.8|4.64||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates||4.64|0.80|
73895918|NCT04525885|147325393|OTHER|Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.45|2.72||||||||2.72|0.45|
73808616|NCT00834639|147167303|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|97.36||||||90.0|93.68|101.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.18|93.68|
73808617|NCT00834639|147167304|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.59||||||90.0|97.07|104.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.24|97.07|
73808618|NCT00834639|147167305|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.36||||||90.0|97.35|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.46|97.35|
73808619|NCT03382834|147167327|SUPERIORITY|||||||0.68|||||||t-test, 1 sided|The hypothesis was that tamoxifen would enhance the HIV transcription effect of vorinostat (i.e., log10 change would be greater in Arm A than Arm B)||||||0.68
73808620|NCT03382834|147167329|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
73808621|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. Statistically, the test of prolongation is equivalent to a non-inferiority test versus placebo by crossover design, with an non-inferiority margin of 10 ms.|Least-Squares Mean Double Delta Value|-0.99|||||ONE_SIDED|95.0||0.635||||||"Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).~Power Calculation:~Enrollment of 72 subjects would provide at least 84% power to conclude a negative effect, given that up to 16 subjects may withdraw early prior to beginning to replace subjects (at least 56 subjects evaluable), and assuming a standard deviation of ΔΔQTcF of 7 msec and an underlying effect of 5 msec."||0.635||
73808622|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.59|||||ONE_SIDED|95.0||2.2||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.200||
73808623|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.17|||||ONE_SIDED|95.0||1.795||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.795||
73808624|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.42|||||ONE_SIDED|95.0||3.044||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.044||
73808625|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||ONE_SIDED|95.0||2.792||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.792||
73808626|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.45|||||ONE_SIDED|95.0||2.074||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.074||
73808627|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.83|||||ONE_SIDED|95.0||0.79||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||0.790||
73808628|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.03|||||ONE_SIDED|95.0||1.65||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.650||
73808629|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.53|||||ONE_SIDED|95.0||1.131||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.131||
73808630|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||ONE_SIDED|95.0||2.815||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.815||
73895919|NCT01008423|147325397|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).||||<0.0001
73808631|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.36|||||ONE_SIDED|95.0||3.997||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.997||
73808632|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.18|||||ONE_SIDED|95.0||3.812||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.812||
73808633|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.59|||||ONE_SIDED|95.0||4.228||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||4.228||
73808634|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|3.04|||||ONE_SIDED|95.0||4.674||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||4.674||
73808635|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.63|||||ONE_SIDED|95.0||3.259||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.259||
73808636|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.07|||||ONE_SIDED|95.0||1.566||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.566||
73808637|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.82|||||ONE_SIDED|95.0||3.459||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.459||
73808638|NCT03613649|147167332|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.72|||||ONE_SIDED|95.0||3.415||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.415||
73808639|NCT03613649|147167337|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.19|||||ONE_SIDED|98.75|8.257|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 1 h after dose.|||8.257|
73808640|NCT03613649|147167337|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.79|||||ONE_SIDED|98.75|8.86|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 2 h after dose.|||8.860|
73808641|NCT03613649|147167337|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.62|||||ONE_SIDED|98.75|8.683|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 3 h after dose.|||8.683|
73808642|NCT03613649|147167337|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.63|||||ONE_SIDED|98.75|8.698|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 4 h after dose.|||8.698|
73808643|NCT00750139|147167383|SUPERIORITY_OR_OTHER|||||||0.01||||||The first primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025.|Cochran-Mantel-Haenszel|||"The first primary efficacy hypotheses tests are:~H01: p1 ≤ p01 vs. H1: p1 \> p01 where p01 and p1 denote the proportions of complete cure in the placebo 2wks and NAFT-500 groups, respectively."||||0.010
73895920|NCT00934843|147325412|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.35|TWO_SIDED|95.0|0.45|1.33|||Multivariate risk computation|||The current study was designed with an anticipated enrollment of 87 patients per treatment arm to achieve a statistical power of 80% (1- β) while controlling type I error at 0.05 (α) using a more conservative estimate of LCOS rate in the Single Dose MP group of 33%, and an incidence of LCOS in the Two Dose MP group of 15%.||1.33|0.45|0.35
73895921|NCT00934843|147325413|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||A repeated measures analysis of variance framework was used for longitudinal analysis of inotrope score. In order to identify potential confounding variables, a variable was considered a relevant covariate and added into the model with a p ≤ 0.15.|ANCOVA|||||||0.43
73808644|NCT00750139|147167383|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The second primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025|Cochran-Mantel-Haenszel|||"The second primary efficacy hypotheses tests are:~H02: p2 ≤ P02 vs. H2: P2 \> p02 where p02 and p2 are denote proportions of complete cure in the placebo 4wks and Naftin 1% groups, respectively"||||0.001
73808645|NCT03600194|147167385|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|Design\*Therapy interaction term||||||.019
73808646|NCT00601172|147167418|SUPERIORITY_OR_OTHER||difference in percentage of participants|1.0||||0.7273|TWO_SIDED|95.0|-4.6|6.6||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||6.6|-4.6|0.7273
73808647|NCT00601172|147167419|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.0||||0.4771|TWO_SIDED|95.0|-1.8|3.8||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||3.8|-1.8|0.4771
73808648|NCT00601172|147167420|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.0||||0.7273|TWO_SIDED|95.0|-4.6|6.6|||Pooled Z test|p-value based on normal approximation to the binomial using a pooled Z test.|The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||6.6|-4.6|0.7273
73808649|NCT00601172|147167421|SUPERIORITY_OR_OTHER||Treatment difference (%)|6.0||||0.0317|TWO_SIDED|95.0|0.5|11.5||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test|||Placebo vs Casopitant 90 mg||11.5|0.5|0.0317
73808650|NCT00601172|147167422|SUPERIORITY_OR_OTHER|||||||0.056|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-120 hours)||||0.0560
73808651|NCT00601172|147167422|SUPERIORITY_OR_OTHER|||||||0.0443|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-24 hours)||||0.0443
73895922|NCT00934843|147325415|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.|ANCOVA|||||||0.052
73808652|NCT00601172|147167422|SUPERIORITY_OR_OTHER|||||||0.1709|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (24-120 hours)||||0.1709
73808653|NCT00601172|147167423|SUPERIORITY_OR_OTHER||Treatment difference (%)|-1.8||||0.3986|TWO_SIDED|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)||2.3|-5.9|0.3986
73808654|NCT00601172|147167423|SUPERIORITY_OR_OTHER||Treatment difference (%)|-0.9||||0.3545|TWO_SIDED|95.0|-2.7|1.0|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)||1.0|-2.7|0.3545
73808655|NCT00601172|147167423|SUPERIORITY_OR_OTHER||Treatment difference (%)|-1.8||||0.3986|TWO_SIDED|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)||2.3|-5.9|0.3986
73808656|NCT00601172|147167424|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.6795|TWO_SIDED|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)||3.5|-5.4|0.6795
73808657|NCT00601172|147167424|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.4507|TWO_SIDED|95.0|-3.1|1.4|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)||1.4|-3.1|0.4507
73808658|NCT00601172|147167424|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.6795|TWO_SIDED|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)||3.5|-5.4|0.6795
73808659|NCT00601172|147167425|SUPERIORITY_OR_OTHER||Difference in percentage of participants|2.1||||0.4846|TWO_SIDED|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||8.0|-3.8|0.4846
73808660|NCT00601172|147167425|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.8||||0.6101|TWO_SIDED|95.0|-2.3|3.9|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||3.9|-2.3|0.6101
73808661|NCT00601172|147167425|SUPERIORITY_OR_OTHER||Percentage of participants|2.1||||0.4846|TWO_SIDED|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||8.0|-3.8|0.4846
73808662|NCT00601172|147167426|SUPERIORITY_OR_OTHER||Difference in percentage of participants|3.8||||0.1356|TWO_SIDED|95.0|-1.2|8.9|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||8.9|-1.2|0.1356
73808663|NCT00601172|147167426|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.1||||0.028|TWO_SIDED|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||15.4|0.9|0.0280
73808664|NCT00601172|147167426|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.1||||0.028|TWO_SIDED|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||15.4|0.9|0.0280
73808665|NCT00601172|147167427|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.7799|TWO_SIDED|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||5.5|-7.3|0.7799
73808666|NCT00601172|147167427|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.5||||0.7883|TWO_SIDED|95.0|-3.2|4.2|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||4.2|-3.2|0.7883
73808667|NCT00601172|147167427|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.7799|TWO_SIDED|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||5.5|-7.3|0.7799
73808668|NCT00601172|147167428|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-7.3||||0.0507|TWO_SIDED|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||0.0|-15|0.0507
73808669|NCT00601172|147167428|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-4.7||||0.08|TWO_SIDED|95.0|-9.9|0.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||0.5|-9.9|0.0800
73808670|NCT00601172|147167428|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-7.3||||0.0507|TWO_SIDED|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||0.0|-15|0.0507
73808671|NCT00601172|147167429|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-2.6|||||TWO_SIDED|97.5|-9.9|4.7|||||The parameter estimated was difference in percentage of participants with response.|Nausea Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)||4.7|-9.9|
73808672|NCT00601172|147167429|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.7||||||97.5|-5.2|6.6|||||The parameter estimated was difference in percentage of participants with response.|Vomiting Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)||6.6|-5.2|
73808673|NCT00601172|147167430|SUPERIORITY_OR_OTHER|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-120 hours) in Cycle 1||||0.1572
73808674|NCT00601172|147167430|SUPERIORITY_OR_OTHER|||||||0.2908|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-24 hours) in Cycle 1||||0.2908
73808675|NCT00601172|147167430|SUPERIORITY_OR_OTHER|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (24-120 hours) in Cycle 1||||0.1572
73808676|NCT01669174|147167468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|106.1|||<|0.001|TWO_SIDED|90.0|104.64|107.58|||ANCOVA|||Week 4||107.58|104.64|<0.001
73808677|NCT01669174|147167468|SUPERIORITY_OR_OTHER||Median Difference (Net)|107.75|||<|0.001|TWO_SIDED|90.0|106.18|109.35|||ANCOVA|||Week 8||109.35|106.18|<0.001
73808678|NCT01669174|147167468|SUPERIORITY_OR_OTHER||Median Difference (Net)|108.63|||<|0.001|TWO_SIDED|90.0|106.31|111.0|||ANCOVA|||Week 16||111.00|106.31|<0.001
73808679|NCT01669174|147167468|SUPERIORITY_OR_OTHER||Median Difference (Net)|106.63|||<|0.001|TWO_SIDED|90.0|104.39|108.93|||ANCOVA|||Week 24||108.93|104.39|<0.001
73808680|NCT05537441|147167473|SUPERIORITY||Percent Difference|0.64||||0.216|TWO_SIDED||||||2 proportion Z-test|||||||0.216
73808681|NCT05537441|147167474|SUPERIORITY||Percent Difference|-0.61||||0.34|TWO_SIDED||||||2 proportion Z-test|||Previously vaccinated||||0.34
73808682|NCT05537441|147167474|SUPERIORITY||Percent Difference|-0.45||||0.247|TWO_SIDED||||||2 proportion Z-test|||Previously unvaccinated||||0.247
73808683|NCT00614523|147167489|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.13|TWO_SIDED|95.0|0.66|1.05|||Anderson-Gill model|Anderson-Gill model using the model-based variance estimate and stratified by the randomization stratification factors|Romiplostim /Placebo|||1.05|0.66|0.13
73808684|NCT00614523|147167490|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.766|||<|0.001|TWO_SIDED|95.0|0.66|0.88|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo|||0.88|0.66|<0.001
73808685|NCT00614523|147167491|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.922||||0.026|TWO_SIDED|95.0|0.86|0.99|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo|||0.99|0.86|0.026
73808686|NCT00614523|147167492|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.739|||<|0.001|TWO_SIDED|95.0|0.68|0.8|||Poisson Regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||0.8|0.68|<0.001
73808687|NCT00614523|147167493|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.6|||<|0.001|TWO_SIDED|95.0|4.7|51.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for stratification factors.|Romiplostim /Placebo|||51.8|4.7|<0.001
73808688|NCT00614523|147167494|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.402||||0.032|TWO_SIDED|95.0|1.03|1.91|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||1.91|1.03|0.032
73808689|NCT00614523|147167498|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.639|||<|0.001|TWO_SIDED|95.0|0.57|0.71|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||0.71|0.57|<0.001
73808690|NCT00722566|147167516|NON_INFERIORITY_OR_EQUIVALENCE|Assuming ORRs are 35.5% for both SC and IV, one-sided alpha level of 0.025, and approximately 80% power, approximately 216 subjects (144 SC:72 IV) are needed to show non-inferiority of SC to IV VELCADE.|ORR_SQ - 0.6 ORR_IV|16.8||||0.00201|TWO_SIDED|95.0|6.1|27.1|||Farrrington and Manning|CONOR P. FARRINGTON AND GODFREY MANNING STATISTICS IN MEDICINE, VOL. 9, 1447-1454(1990).||In this trial, non-inferiority is defined as retaining 60% of the IV (active control) treatment effect as measured by ORR. The non-inferiority hypothesis can be stated as: H0: ORRSC - 0.60 ORRIV \<0 vs. H1: ORRSC - 0.60 ORRIV ≥0 (non-inferiority).||27.1|6.1|0.00201
73808691|NCT01895270|147167534|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.42||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||.42
73808692|NCT02091375|147167539|SUPERIORITY||Median Difference (Final Values)|-22.79||||0.0123|TWO_SIDED|95.0|-41.06|-5.43|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach.|||-5.43|-41.06|0.0123
73808693|NCT02091375|147167540|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0784|TWO_SIDED|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|Stratified by age group (2-5 years, 6-12 years, and 13-18 years).||||4.30|0.93|0.0784
73808694|NCT04507256|147167607|OTHER|Bioavailability|Ratio of geometric mean AUCinf|68.69|||||||||||||The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD8895.|Bioavailability of AZD8895 at the end of study (Day 361)||||
73808695|NCT04507256|147167607|OTHER|Bioavailability|Ratio of geometric mean AUCinf|65.02|||||||||||||The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD1061.|Bioavailability of AZD1061 at the end of study (Day 361)||||
73808696|NCT03330262|147167624|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
73808697|NCT03330262|147167625|OTHER|Ho: mean change = 0||||||0.006|||||||Mixed Models Analysis|||||||0.006
73808698|NCT03330262|147167625|OTHER|Ho: mean change = 0||||||0.869|||||||Mixed Models Analysis|||||||0.869
73808699|NCT03330262|147167626|SUPERIORITY|||||||0.448|||||||Mixed Models Analysis|||||||0.448
73808700|NCT03330262|147167627|OTHER|This test evaluated whether the change in ABC was significant for the BALCAP condition##. Ho: mean = 0||||||0.273|||||||Mixed Models Analysis|||||||0.273
73808701|NCT03330262|147167627|OTHER|This test evaluated if the change in ABC score was significant for the control group.||||||0.796|||||||Mixed Models Analysis|||||||0.796
73808702|NCT03330262|147167628|OTHER|Ho: Mean change in score = 0||||||0.189|||||||Mixed Models Analysis|||||||0.189
73808703|NCT03330262|147167628|OTHER|Ho: mean change = 0||||||0.713|||||||Mixed Models Analysis|||||||0.713
73808704|NCT01647516|147167649|SUPERIORITY||Odds Ratio (OR)|3.262||||0.0482|TWO_SIDED|95.0|0.969|10.984|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||10.984|0.969|0.0482
73808705|NCT01647516|147167649|SUPERIORITY||Odds Ratio (OR)|2.5||||0.1422|TWO_SIDED|95.0|0.722|8.661|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||8.661|0.722|0.1422
73808706|NCT01647516|147167650|SUPERIORITY||Odds Ratio (OR)|2.158||||0.0207|TWO_SIDED|95.0|1.093|4.263|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||4.263|1.093|0.0207
73808707|NCT01647516|147167650|SUPERIORITY||Odds Ratio (OR)|1.947||||0.0648|TWO_SIDED|95.0|0.961|3.946|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||3.946|0.961|0.0648
73808708|NCT01647516|147167651|SUPERIORITY|||||||0.0042|||||||ANCOVA|The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).||||||0.0042
73808709|NCT01647516|147167651|SUPERIORITY|||||||0.1415|||||||ANCOVA|The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).||||||0.1415
73808710|NCT01647516|147167652|SUPERIORITY||Odds Ratio (OR)|3.861||||0.0023|TWO_SIDED|95.0|1.572|9.484|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||9.484|1.572|0.0023
73808711|NCT01647516|147167652|SUPERIORITY||Odds Ratio (OR)|2.647||||0.0348|TWO_SIDED|95.0|1.058|6.621|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||6.621|1.058|0.0348
73808712|NCT01647516|147167653|SUPERIORITY||Odds Ratio (OR)|4.332||||0.0108|TWO_SIDED|95.0|1.323|14.186|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||14.186|1.323|0.0108
73808713|NCT01647516|147167653|SUPERIORITY||Odds Ratio (OR)|5.443||||0.0021|TWO_SIDED|95.0|1.706|17.365|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||17.365|1.706|0.0021
73808714|NCT01647516|147167654|SUPERIORITY|Stratified by prior anti-TNF therapy experience, (yes or no).|Odds Ratio (OR)|4.03||||0.0002|TWO_SIDED|95.0|1.871|8.678|||Cochran-Mantel-Haenszel|||||8.678|1.871|0.0002
73895923|NCT00934843|147325416|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.||||||0.047
73808715|NCT01647516|147167654|SUPERIORITY||Odds Ratio (OR)|2.154||||0.0571|TWO_SIDED|95.0|0.974|4.763|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||4.763|0.974|0.0571
73808716|NCT01647516|147167655|SUPERIORITY||Odds Ratio (OR)|3.557||||0.0046|TWO_SIDED|95.0|1.444|8.762|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||8.762|1.444|0.0046
73808717|NCT01647516|147167655|SUPERIORITY||Odds Ratio (OR)|3.428||||0.0064|TWO_SIDED|95.0|1.384|8.494|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||8.494|1.384|0.0064
73808718|NCT04964544|147167665|OTHER||Percentage|90.7|||||TWO_SIDED|95.0|88.9|92.3|||||Proportion of participants|Proportion of participants with overall correct initial TASS assessment, with mitigations, worst case imputation (Self-Selection Population)||92.3|88.9|
73808719|NCT04964544|147167666|OTHER||Percentage|98.1|||||TWO_SIDED|95.0|97.1|98.8|||||Proportion of participants|Proportion of participants with overall correct final TASS assessment, with mitigations, worst case imputation (Per Protocol Population)||98.8|97.1|
73808720|NCT04964544|147167667|OTHER||Mean percent change from paseline|-35.48|||||TWO_SIDED|95.0|-36.63|-34.33||||||||-34.33|-36.63|
73895924|NCT00183729|147325426|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.42|TWO_SIDED||||||Mixed Models Analysis|||Null: the two groups would not differ in depressive symptoms over time (ie both groups would improve equally in terms of their depressive symptoms) Power calculation: none; this was a pilot study||||0.42
73808721|NCT01899742|147167684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|||<|0.001|TWO_SIDED|95.0|0.045|0.131|||Mixed Models Analysis|||||0.131|0.045|<0.001
73808722|NCT01899742|147167685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.004|TWO_SIDED|95.0|0.024|0.122|||Mixed Models Analysis|||||0.122|0.024|0.004
73808723|NCT02195310|147167689|SUPERIORITY|||||||0.7007|||||||Fisher Exact Test (2-sided)|||||||0.7007
73808724|NCT01154088|147167690|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|5.42|||||TWO_SIDED|95.0|-1.41|12.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups A as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||12.25|-1.41|
73808725|NCT01154088|147167690|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|-0.41|||||TWO_SIDED|95.0|-4.11|3.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups C as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||3.25|-4.11|
73808726|NCT01154088|147167690|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|6.83|||||TWO_SIDED|95.0|3.28|10.78||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups W-135 as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||10.78|3.28|
73808727|NCT01154088|147167690|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|7.02|||||TWO_SIDED|95.0|2.63|11.58||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups Y as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||11.58|2.63|
73808728|NCT01154088|147167691|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.04|||||TWO_SIDED|95.0|0.92|1.17||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups A, 1 month after vaccination as measured at GSK.||1.17|0.92|
73808729|NCT01154088|147167691|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.15|||||TWO_SIDED|95.0|0.96|1.37||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups C, 1 month after vaccination as measured at GSK.||1.37|0.96|
73808730|NCT01154088|147167691|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.8|1.04||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups W-135, 1 month after vaccination as measured at GSK.||1.04|0.8|
73808731|NCT01154088|147167691|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.88|||||TWO_SIDED|95.0|0.78|0.99||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups Y, 1 month after vaccination as measured at GSK.||0.99|0.78|
73808732|NCT02447497|147167725|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.51|4.1|||Paired t-test|||48 hours post treatment time point. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||4.10|0.51|<0.0001
73808733|NCT02447497|147167725|SUPERIORITY||Mean Difference (Final Values)|2.37|STANDARD_ERROR_OF_MEAN|0.29||0.0001|TWO_SIDED|95.0|0.6|5.75|||Paired t-test|||48 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||5.75|0.60|0.0001
73808734|NCT02447497|147167725|SUPERIORITY||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|0.23||0.0001|TWO_SIDED|95.0|0.17|3.75|||Paired t-test|||72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||3.75|0.17|0.0001
73808735|NCT02447497|147167725|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|0.33||0.0001|TWO_SIDED|95.0|0.13|5.04|||Paired t-test|||72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||5.04|0.13|0.0001
73808736|NCT02017912|147167729|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.5567||0.7208|TWO_SIDED|95.0|-1.321|0.92|||Mixed Models Analysis|||||0.920|-1.321|0.7208
73808737|NCT02017912|147167730|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.881||0.641|TWO_SIDED|95.0|-2.187|1.36|||Mixed Models Analysis|||||1.360|-2.187|0.6410
73808738|NCT01322035|147167731|EQUIVALENCE|95% confidence limits from standard deviation of the mean were used as the equivalence.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|95% confidence limits from standard deviation||||||<0.05
73808739|NCT02496091|147167738|OTHER||95% confidence interval (using the exact|92.7|||||TWO_SIDED|95.0|88.8|95.5||||||Only descriptive statistics The implant success rate is analyzed on an implant level (i.e. percent of successful implants) as well as subject level (i.e. percentage of subjects with no unsuccessful implants). This proportion is presented together with a 95% confidence interval (using the exact Binomial approach) and an average follow-up time.||95.5|88.8|
73808740|NCT02272842|147167744|SUPERIORITY|The study had 80% power to detect a standardized effect size of 0.22 and had 90% power to detect an effect size of 0.28. In these calculations, we assumed a loss to follow-up of 10%. Details on the samples size calculations are also presented in the previously published protocol paper.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.35|>|0.16|TWO_SIDED|95.0|-0.54|0.87||The main analysis was the change in cognitive scores from baseline until the end of the intervention.|t-test, 2 sided||This is the P-value for the effect on the cognitive scores.|||.87|-.54|>.16
73808741|NCT02272842|147167754|SUPERIORITY|the means were compared using Students t-test|Mean Difference (Final Values)|-0.5|||>|0.3|TWO_SIDED|95.0|-1.97|0.94||"Mean difference -0.5 points in the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition.~95 % Confidence Interval of the mean difference: (-1.97, 0.94)"|t-test, 2 sided|||Comparing mean differences between the two study arms||0.94|-1.97|>.3
73808742|NCT02396420|147167761|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808743|NCT02396420|147167762|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808744|NCT02396420|147167763|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808745|NCT02396420|147167764|OTHER|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|||
73808746|NCT02396420|147167765|OTHER|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|||
73808747|NCT02396420|147167766|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808748|NCT02396420|147167767|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808749|NCT02396420|147167768|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808750|NCT02396420|147167769|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808751|NCT02396420|147167770|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808752|NCT02396420|147167771|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808753|NCT02396420|147167772|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808754|NCT02396420|147167773|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808755|NCT02396420|147167774|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808756|NCT02396420|147167775|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808757|NCT02396420|147167776|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808758|NCT02396420|147167777|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
73808759|NCT03518619|147167787|OTHER|This is a single group design. Paired-samples t-tests were conducted.|||||<|0.05||||||This is a calculated p-value.|t-test, 2 sided|||||||<.05
73808760|NCT03518619|147167788|OTHER|This is a single group design. Paired-samples t-tests were conducted.|||||<|0.01||||||This is a calculated p-value.|t-test, 2 sided|||||||<.01
73808761|NCT01273623|147167789|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73808762|NCT01640379|147167792|SUPERIORITY||Odds Ratio (OR)|0.4||||0.07|TWO_SIDED|95.0|0.15|1.09||Judged by type one error limit alpha = 0.05.|t-test, 2 sided||The odds ratio is for the difference in chlamydia or gonorrhea (CT/GC) rates between arms at ninety days after intervention.|A comparison of Chlamydia or Gonorrhea positivity at 90 days post intervention.||1.09|0.15|0.070
73808763|NCT01640379|147167792|SUPERIORITY||Odds Ratio (OR)|0.59||||0.043|TWO_SIDED|95.0|0.39|0.98||Judged by type one error limit alpha = 0.05.|generalized estimating equations||The odds ratio is for the difference in rate of change over time between arms, so is the difference in the odds increment for those receiving TECH N intervention versus the control group.|"We used generalized estimating equations to test for a difference in the trend of chlamydia or gonorrhea (CT/GC) rates over the study period.~The null hypothesis is that rates of CT/GC for women in the intervention arm were changing over the study period similarly to CT/GC rates in the control arm."||0.98|0.39|0.043
73808764|NCT01640379|147167793|SUPERIORITY||Odds Ratio (OR)|92.2|||<|0.001|TWO_SIDED|95.0|37.0|230.1|||Chi-squared|Adjusted for age, debut age, number of lifetime partners, baseline STI status (any vs none), insurance, and if woman had prior pregnancy.|Odds ratio is interpretable as the expected chance of having a 72 follow-up for intervention women compared to women in the control arm, given similar age, debut age, number of lifetime partners, baseline STI status, insurance, and pregnancy history.|H0: Women in TECHN arm had 72 hour visit with same frequency as women in control arm.||230.1|37.0|<0.001
73808765|NCT01640379|147167793|SUPERIORITY||Odds Ratio (OR)|0.6||||0.084|TWO_SIDED|95.0|0.36|1.05|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for intervention arm relative to control.|H0: Women in TECHN arm reported complete adherence to medication regimen (yes or no) with same frequency as women in control arm.||1.05|0.36|0.084
73808766|NCT01640379|147167793|SUPERIORITY||Odds Ratio (OR)|0.9||||0.867|TWO_SIDED|95.0|0.36|2.34|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for the chances of partner notification among TECH N recipients, relative to those in control arm.|H0: Women in TECHN arm notified their partners about their diagnoses more often than women in the control arm.||2.34|0.36|0.867
73808767|NCT01640379|147167793|SUPERIORITY||Odds Ratio (OR)|0.6||||0.153|TWO_SIDED|95.0|0.33|1.19|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for partners of TECH-N recipients versus partners of women in control arm.|H0: Partners of women receiving the TECH-N intervention were treated more often than the partners of women in the control arm.||1.19|0.33|0.153
73808768|NCT01640379|147167793|SUPERIORITY||Odds Ratio (OR)|1.0||||0.351|TWO_SIDED|95.0|0.86|1.06|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for women in the TECH-N arm relative to women in the control arm.|H0: Women in the TECHN arm practiced temporary sexual abstinence for two weeks after their diagnosis more often than those in the control arm.||1.06|0.86|0.351
73808769|NCT00519428|147167802|SUPERIORITY|Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy).|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|4.0||0.05|TWO_SIDED|||||"Each individual test will require the calculated p to be \< .0916 to declare that comparison to be significant. Since the hypothesis requires both comparisons to be significant, this produces an over-all alpha of .05."|Cochran-Mantel-Haenszel|||Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy). Therefore each analysis will be done twice and it will be required that both analyses be significant to declare the over-all study significant.||||.05
73808770|NCT00519428|147167804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|8.0||0.0916|TWO_SIDED|95.0||||escitalopram + bupropion vs. escitalopram: F(1,159) = 1.93, ns escitalopram + bupropion vs. bupropion: F (1,157) = 1.99, ns|ANCOVA|adjusting for baseline score and country||To test the hypothesis that escitalopram + bupropion would have superior efficacy relative to each monotherapy, the group receiving both medications was separately compared to each monotherapy group, covarying for baseline score and country||||.0916
73808771|NCT04064411|147167807|NON_INFERIORITY|"Noninferiority margin = 2.0% for abaloparatide-sMTS compared with abaloparatide-SC.~Non-inferiority was to be concluded if the lower bound of the 2-sided 95% confidence interval (CI) for the estimated treatment difference (abaloparatide-sMTS minus abaloparatide-SC) in the percent change from baseline in lumbar spine BMD at 12 months was above -2.0% using a Mixed Model for Repeated Measures (MMRM) analysis."|Least Squares Means (LSM) Difference|-3.721|||||TWO_SIDED|95.0|-5.0089|-2.4331|||||LSM Difference = abaloparatide-sMTS minus abaloparatide-SC|||-2.4331|-5.0089|
73808772|NCT03395184|147167810|OTHER||Percentage risk difference|14.3||||0.0119|TWO_SIDED|90.0|4.0|24.5|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum (min) risk weight method (Mehrotra-Railkar 2000)|||24.5|4.0|0.0119
73808773|NCT03395184|147167810|OTHER||Percentage risk difference|21.4||||0.0012|TWO_SIDED|90.0|10.0|32.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||32.9|10.0|0.0012
73808774|NCT03395184|147167824|OTHER||Percentage risk difference|13.3||||0.039|TWO_SIDED|90.0|1.0|25.7|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||25.7|1.0|0.0390
73808775|NCT03395184|147167824|OTHER||Percentage risk difference|29.7||||0.0001|TWO_SIDED|90.0|17.2|42.2|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||42.2|17.2|0.0001
73808776|NCT03395184|147167825|OTHER||LS mean difference|-3.0||||0.0007|TWO_SIDED|90.0|-4.55|-1.48|||ANCOVA|The ANCOVA model included treatment and baseline disease activity/extent as factors, and baseline SES-CD score as a covariate.||||-1.48|-4.55|0.0007
73808777|NCT03395184|147167825|OTHER||LS mean difference|-4.9|||<|0.0001|TWO_SIDED|90.0|-6.62|-3.26|||ANCOVA|The ANCOVA model included treatment and baseline disease activity/extent as factors, and baseline SES-CD score as a covariate.||||-3.26|-6.62|<.0001
73808778|NCT03395184|147167826|OTHER||Percentage risk difference|13.9||||0.0279|TWO_SIDED|90.0|2.1|25.6|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using using minimum risk weight method (Mehrotra-Railkar, 2000).|||25.6|2.1|0.0279
73808779|NCT03395184|147167826|OTHER||Percentage risk difference|31.5|||<|0.0001|TWO_SIDED|90.0|19.1|43.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||43.9|19.1|<.0001
73808780|NCT03395184|147167827|OTHER||Percentage risk difference|2.5||||0.2922|TWO_SIDED|90.0|-4.3|9.3|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||9.3|-4.3|0.2922
73808781|NCT03395184|147167827|OTHER||Percentage risk difference|7.4||||0.0449|TWO_SIDED|90.0|-0.4|15.2|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||15.2|-0.4|0.0449
73808782|NCT03395184|147167828|OTHER||Percentage risk difference|5.8||||0.0998|TWO_SIDED|90.0|-1.6|13.3|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||13.3|-1.6|0.0998
73808783|NCT03395184|147167828|OTHER||Percentage risk difference|11.8||||0.0111|TWO_SIDED|90.0|2.8|20.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||20.9|2.8|0.0111
73808784|NCT03053063|147167844|SUPERIORITY||Percentage Difference|1.9||||0.5572|TWO_SIDED|95.0|-4.4|8.2||Difference between SEL 18 mg vs Placebo, 95% confidence interval (CI) and p-value were obtained by stratified Mantel-Haenszel method adjusting for baseline (BL) diabetes mellitus status and BL Enhanced Liver Fibrosis (ELF) score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||8.2|-4.4|0.5572
73808785|NCT03053063|147167844|SUPERIORITY||Percentage Difference|0.3||||0.9272|TWO_SIDED|95.0|-6.0|6.5||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||6.5|-6.0|0.9272
73808786|NCT03053063|147167847|SUPERIORITY||Percentage Difference|3.8||||0.285|TWO_SIDED|95.0|-3.1|10.6||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||10.6|-3.1|0.2850
73808787|NCT03053063|147167847|SUPERIORITY||Percentage Difference|1.5||||0.6731|TWO_SIDED|95.0|-5.3|8.2||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||8.2|-5.3|0.6731
73808788|NCT03053063|147167849|SUPERIORITY||Percentage Difference|-1.7||||0.365|TWO_SIDED|95.0|-5.5|2.0||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||2.0|-5.5|0.3650
73808789|NCT03053063|147167849|SUPERIORITY||Percentage Difference|-0.4||||0.8557|TWO_SIDED|95.0|-4.3|3.6||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||3.6|-4.3|0.8557
73808790|NCT01970475|147167855|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis was tested by comparing the 2-sided 90% confidence interval (CI) of the RR of ACR20 at week 24 between ABP 501 and adalimumab with an equivalence margin of (0.738, 1/0.738).|Risk Ratio (RR)|1.039|||||TWO_SIDED|90.0|0.954|1.133|||||Based on a generalized linear model adjusted for geographic region and prior biological use for RA as covariates in the model.|The study hypothesis was that there were no clinically meaningful differences between ABP 501 and adalimumab in risk ratio (RR) of ACR20 at week 24.||1.133|0.954|
73808791|NCT05129293|147167869|SUPERIORITY|||||||0.229|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.229
73808792|NCT05129293|147167870|SUPERIORITY|||||||0.04|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.040
73808793|NCT05129293|147167871|SUPERIORITY|||||||0.266|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.266
73808794|NCT01953874|147167887|OTHER|The primary analysis was based on the Wilcoxon-Mann-Whitney test and therefore the power calculation was approximated using the approach of Tang.||||||0.916|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint was a composite measure of global rank order response based on survival time, freedom from CV hospitalization, and improvement in functional capacity measured by percent change in 6MWD from baseline to 6 months. The plan was to randomize up to 215 subjects. However, due to safety issues observed in SERVE-HF, randomization was stopped at 126 subjects.||||0.916
73808795|NCT03339726|147167907|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.22||0.3|TWO_SIDED|95.0|-0.205|0.662||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.662|-0.205|0.300
73808796|NCT03339726|147167907|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.222||0.569|TWO_SIDED|95.0|-0.311|0.564||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.564|-0.311|0.569
73808797|NCT03339726|147167907|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.645|TWO_SIDED|95.0|-0.537|0.333||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.333|-0.537|0.645
73808798|NCT03339726|147167908|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.26||0.346|TWO_SIDED|95.0|-0.267|0.759||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.759|-0.267|0.346
73808799|NCT03339726|147167908|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.263||0.938|TWO_SIDED|95.0|-0.498|0.539||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.539|-0.498|0.938
73808800|NCT03339726|147167908|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.261||0.389|TWO_SIDED|95.0|-0.741|0.289||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.289|-0.741|0.389
73808801|NCT03339726|147167909|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.23||0.607|TWO_SIDED|95.0|-0.33|0.57|||ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.33|0.607
73895925|NCT00183729|147325428|SUPERIORITY|(no comments)|Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|7.0||0.06|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis: functional recovery would be the same in both groups. Power calculation: none. This was a pilot study.||||0.06
73808802|NCT03339726|147167909|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.232||0.085|TWO_SIDED|95.0|-0.06|0.86||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.86|-0.06|0.085
73808803|NCT03339726|147167909|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.23||0.22|TWO_SIDED|95.0|-0.17|0.74||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.74|-0.17|0.220
73808804|NCT03339726|147167910|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.271||0.633|TWO_SIDED|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.40|0.633
73808805|NCT03339726|147167910|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.273||0.952|TWO_SIDED|95.0|-0.52|0.56||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.56|-0.52|0.952
73808806|NCT03339726|147167910|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.272||0.678|TWO_SIDED|95.0|-0.65|0.42||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.42|-0.65|0.678
73895926|NCT03698591|147325429|OTHER||F-statistic|6.155||||0.019|TWO_SIDED|||||P-value corresponds to 3 way interaction. A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distancing performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.019
73808807|NCT03339726|147167911|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.25||0.126|TWO_SIDED|95.0|-0.11|0.88||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.88|-0.11|0.126
73808808|NCT03339726|147167911|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.253||0.27|TWO_SIDED|95.0|-0.22|0.78||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.78|-0.22|0.270
73808809|NCT03339726|147167911|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.251||0.676|TWO_SIDED|95.0|-0.6|0.39||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.39|-0.60|0.676
73808810|NCT03339726|147167912|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.264||0.421|TWO_SIDED|95.0|-0.31|0.73||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.73|-0.31|0.421
73808811|NCT03339726|147167912|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.266||0.97|TWO_SIDED|95.0|-0.54|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-0.54|0.970
73895927|NCT03698591|147325429|OTHER||F-statistic|5.911||||0.021|TWO_SIDED|||||P-value corresponds to two-way interaction. A priori significance threshold of p \< .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distancing performance would not differ by study period. Within-subjects factors included task condition and study period.||||.021
73808812|NCT03339726|147167912|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.265||0.401|TWO_SIDED|95.0|-0.74|0.3||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.30|-0.74|0.401
73808813|NCT03339726|147167913|SUPERIORITY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.272||0.257|TWO_SIDED|95.0|-0.23|0.85||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.85|-0.23|0.257
73808814|NCT03339726|147167913|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.275||0.877|TWO_SIDED|95.0|-0.5|0.58||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.58|-0.50|0.877
73808815|NCT03339726|147167913|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.273||0.329|TWO_SIDED|95.0|-0.8|0.27||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.27|-0.80|0.329
73808816|NCT03339726|147167914|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.298||0.469|TWO_SIDED|95.0|-0.37|0.8||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.80|-0.37|0.469
73808817|NCT03339726|147167914|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.301||0.924|TWO_SIDED|95.0|-0.57|0.62||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.62|-0.57|0.924
73895928|NCT03698591|147325429|OTHER||t-statistic|-1.656||||0.108|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distancing performance between study periods 1 and 2. The null hypothesis was that distancing performance would not differ by study period.||||.108
73808818|NCT03339726|147167914|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.299||0.532|TWO_SIDED|95.0|-0.78|0.4||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.40|-0.78|0.532
73808819|NCT03339726|147167915|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.309||0.579|TWO_SIDED|95.0|-0.78|0.44||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.44|-0.78|0.579
73808820|NCT03339726|147167915|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.312||0.394|TWO_SIDED|95.0|-0.88|0.35||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.35|-0.88|0.394
73808821|NCT03339726|147167915|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.31||0.76|TWO_SIDED|95.0|-0.71|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-0.71|0.760
73808822|NCT03339726|147167916|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.218||0.616|TWO_SIDED|95.0|-0.32|0.539||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.539|-0.320|0.616
73895929|NCT03698591|147325429|OTHER||F-statistic|0.004||||0.948|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.948
73808823|NCT03339726|147167916|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.22||0.734|TWO_SIDED|95.0|-0.359|0.508||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.508|-0.359|0.734
73808824|NCT03339726|147167916|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.218||0.874|TWO_SIDED|95.0|-0.465|0.395||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.395|-0.465|0.874
73808825|NCT03339726|147167917|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.75|TWO_SIDED|95.0|-0.53|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.53|0.750
73808826|NCT03339726|147167917|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.232||0.39|TWO_SIDED|95.0|-0.26|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.26|0.390
73808827|NCT03339726|147167917|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.236|TWO_SIDED|95.0|-0.18|0.73||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.73|-0.18|0.236
73808828|NCT03339726|147167918|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.267||0.707|TWO_SIDED|95.0|-0.63|0.43||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.43|-0.63|0.707
73808829|NCT03339726|147167918|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.269||0.839|TWO_SIDED|95.0|-0.59|0.48||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.48|-0.59|0.839
73808830|NCT03339726|147167918|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.267||0.864|TWO_SIDED|95.0|-0.48|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.48|0.864
73808831|NCT03339726|147167919|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.255||0.794|TWO_SIDED|95.0|-0.44|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.44|0.794
73808832|NCT03339726|147167919|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.257||0.628|TWO_SIDED|95.0|-0.38|0.63||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.63|-0.38|0.628
73808833|NCT03339726|147167919|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.255||0.82|TWO_SIDED|95.0|-0.45|0.56||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.56|-0.45|0.820
73808834|NCT03339726|147167920|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.266||0.33|TWO_SIDED|95.0|-0.27|0.79||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.79|-0.27|0.330
73895930|NCT03698591|147325430|OTHER||F-statistic|0.031||||0.862|TWO_SIDED|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distancing self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.862
73808835|NCT03339726|147167920|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.269||0.631|TWO_SIDED|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.40|0.631
73808836|NCT03339726|147167920|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.266||0.625|TWO_SIDED|95.0|-0.66|0.4||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.40|-0.66|0.625
73808837|NCT03339726|147167921|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.275||0.24|TWO_SIDED|95.0|-0.22|0.87||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.87|-0.22|0.240
73808838|NCT03339726|147167921|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.278||0.865|TWO_SIDED|95.0|-0.5|0.6||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.60|-0.50|0.865
73808839|NCT03339726|147167921|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.275||0.316|TWO_SIDED|95.0|-0.82|0.27||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.27|-0.82|0.316
73808840|NCT03339726|147167922|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.284||0.529|TWO_SIDED|95.0|-0.38|0.74||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.74|-0.38|0.529
73808841|NCT03339726|147167922|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.287||0.997|TWO_SIDED|95.0|-0.56|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.56|0.997
73808842|NCT03339726|147167922|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.285||0.532|TWO_SIDED|95.0|-0.74|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.74|0.532
73808843|NCT03339726|147167923|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.309||0.468|TWO_SIDED|95.0|-0.83|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.83|0.468
73808844|NCT03339726|147167923|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.312||0.218|TWO_SIDED|95.0|-1.0|0.23||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.23|-1.00|0.218
73808845|NCT03339726|147167923|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.309||0.604|TWO_SIDED|95.0|-0.77|0.45||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.45|-0.77|0.604
73808846|NCT03681990|147167930|OTHER|Mixed Model ANOVA with subject as a random effect.||||||0.34||||||F test|ANOVA|||||||0.34
73808847|NCT01246349|147167935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.616|STANDARD_ERROR_OF_MEAN|7.373||0.24|TWO_SIDED|95.0|-5.871|23.103|||Regression, Linear|||Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy \[WEL\] change between the treatment and control groups from baseline to a 6 month follow-up).||23.103|-5.871|0.24
73808848|NCT01246349|147167936|SUPERIORITY_OR_OTHER|||||||0.56|||||||Regression, Linear|||Results published comprise baseline and follow-up BMI z-score means and standard deviations for both the MI and control groups (reported above), as well as the attributable effect of intervention (i.e., the difference in BMI change between the treatment and control groups from baseline to a 6-month follow-up)||||0.56
73808849|NCT01246349|147167937|SUPERIORITY_OR_OTHER|||||||0.09|||||||Regression, Linear|||Results published comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the attributable effect of intervention (i.e., the difference in waist circumference change between the treatment and control groups from baseline to a 6-month follow-up).||||0.09
73808850|NCT01246349|147167939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|1.265||0.88|TWO_SIDED|95.0|-2.301|2.668|||Regression, Linear|||"Based on previous research , baseline CDSS means were expected between 5 - 6.5 with a SD of 3 - 4. It was hypothesized that an attributable effect of 1.5 would be detected.~Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy \[CDSS\] change between the treatment and control groups from baseline to a 6 month follow-up)."||2.668|-2.301|0.88
73808851|NCT03962790|147167942|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the credible interval (CrI) of the mean difference between Test and Control was greater than -5.|Posterior Mean Difference|0.09|STANDARD_DEVIATION|2.281|||TWO_SIDED|95.0|-4.37|4.65|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||4.65|-4.37|
73808852|NCT03962790|147167943|NON_INFERIORITY|Non-inferiority is established if the lower limit of the 95% credible interval is above -5 points in CLUE Scale.|Posterior Mean Difference|-1.02|STANDARD_DEVIATION|1.565|||TWO_SIDED|95.0|-4.07|2.06|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||2.06|-4.07|
73808853|NCT03962790|147167944|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the CrI of the mean difference between Test and Control was less than 0.05.|Posterior Mean Difference|-0.001|STANDARD_DEVIATION|0.0054|||TWO_SIDED|95.0|-0.012|0.01|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.010|-0.012|
73808854|NCT03962790|147167944|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the CrI of the mean difference between Test and Control was less than 0.05.|Posterior Mean Difference|-0.002|STANDARD_DEVIATION|0.0057|||TWO_SIDED|95.0|-0.014|0.009|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.009|-0.014|
73808855|NCT03962790|147167945|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the CrI of the mean difference between Test and Control was greater than -1.|Posterior Mean Difference|0.02|STANDARD_DEVIATION|0.168|||TWO_SIDED|95.0|-0.32|0.34|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.34|-0.32|
73808856|NCT02579343|147167946|SUPERIORITY|||||||0.05||||||P-value above was calculated. Does not reference threshold for clinical significance.|Repeated Measures Analysis of Variance|||||||.05
73808857|NCT02579343|147167947|SUPERIORITY|||||||0.05|||||||Repeated Measures Analysis of Variance|||||||.05
73808858|NCT05027048|147167977|SUPERIORITY||Mean Difference (Net)|211.0|||<|0.05|TWO_SIDED|95.0|-33.0|410.0||a priori threshold for statistical significance p\<0.05|inverse Gaussian distribution and log li|Inverse Gaussian distribution and log link fit to estimate the effect size and 95% CIs|Inverse gaussian regression with a log link was used to calculate the mean reduction in blood loss in the calcium group relative to placebo group.|||410|-33|<0.05
73808859|NCT05027048|147167978|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.48|1.03|||Regression (poisson with robust SE)|||||1.03|0.48|
73808860|NCT05027048|147167979|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.46|1.23|||Poisson regression with robust SE|||||1.23|0.46|
73808861|NCT05027048|147167980|SUPERIORITY||Risk Ratio (RR)|0.56|||||TWO_SIDED|95.0|0.2|1.56||||||||1.56|0.2|
73808862|NCT05027048|147167981|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|95.0|-3.6|0.2|||Regression, Linear|Data were log transformed to approximate a normal distribution prior to linear regression.||||0.2|-3.6|
73808863|NCT05027048|147167983|SUPERIORITY|||||||0.415|||||||Wilcoxon (Mann-Whitney)|||||||0.415
73808864|NCT05027048|147167984|SUPERIORITY|||||||0.566|||||||Wilcoxon (Mann-Whitney)|||||||0.566
73808865|NCT05027048|147167986|SUPERIORITY|||||||0.348|||||||ANOVA|||Repeated measures ANOVA used to analyze differences between groups.||||0.348
73808866|NCT05027048|147167987|SUPERIORITY|||||||0.011|||||||ANOVA|Repeated measures ANOVA.||Repeated measures ANOVA used to assess for difference between groups in the % change from baseline heart rate.||||0.011
73808867|NCT05027048|147167989|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
73808868|NCT05027048|147167990|OTHER||||||||||||||||||"Note: a two-compartment pharmacokinetic model was generated in NONMEM using 6 venous blood ionized calcium measurements per participant at random times. The change in ionized calcium was defined as a measured value minus the measured baseline for the patient.~Once the two-compartment pharmacokinetic model was generated, NONMEM was used to generate a predicted ionized calcium concentration at 10 minutes (Tmax) for each participant to generate mean and 95% confidence interval."|||
73808869|NCT05027048|147167992|SUPERIORITY||Mean Difference (Net)|356.0|||<|0.05|TWO_SIDED|95.0|159.0|515.0|||Inverse Gaussian regression, log link||Reduction in blood loss was calculated by inverse Gaussian regression with a log link as detailed in the description of statistical methods for the primary outcome.|||515|159|<0.05
73808870|NCT03535194|147167993|SUPERIORITY||Risk Difference (RD)|73.5|||<|0.001|TWO_SIDED|95.0|68.2|78.7|||Cochran-Mantel-Haenszel|||||78.7|68.2|<0.001
73895931|NCT03698591|147325430|OTHER||F-statistic|4.04||||0.054|TWO_SIDED|||||P-value corresponds to the main effect of study period. A priori threshold of p \< .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.||||.054
73808871|NCT03535194|147167994|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|62.7|73.3|||Cochran-Mantel-Haenszel|||||73.3|62.7|<0.001
73808872|NCT03535194|147167995|SUPERIORITY||Risk Difference (RD)|81.6|||<|0.001|TWO_SIDED|95.0|76.1|87.0|||Cochran-Mantel-Haenszel|||||87.0|76.1|<0.001
73808873|NCT03535194|147167996|SUPERIORITY||Risk Difference (RD)|51.7|||<|0.001|TWO_SIDED|95.0|47.6|55.8|||Cochran-Mantel-Haenszel|||||55.8|47.6|<0.001
73808874|NCT03535194|147167997|SUPERIORITY||Risk Difference (RD)|23.2|||<|0.001|TWO_SIDED|95.0|19.3|27.1|||Cochran-Mantel-Haenszel|||||27.1|19.3|<0.001
73808875|NCT03535194|147167998|SUPERIORITY||Risk Difference (RD)|53.5|||<|0.001|TWO_SIDED|95.0|47.7|59.3|||Cochran-Mantel-Haenszel|||||59.3|47.7|<0.001
73808876|NCT03535194|147167999|SUPERIORITY||LSMean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|-7.01|-2.88|||Mixed Models Analysis|||||-2.88|-7.01|<0.001
73808877|NCT03535194|147168000|SUPERIORITY||LSMean Difference|-15.15|STANDARD_ERROR_OF_MEAN|0.692|<|0.001|TWO_SIDED|95.0|-16.51|-13.8|||Mixed Models Analysis|||||-13.80|-16.51|<0.001
73808878|NCT03535194|147168001|SUPERIORITY||LSMean Difference|-9.59|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-12.63|-6.55|||Mixed Models Analysis|||||-6.55|-12.63|<0.001
73895932|NCT03698591|147325430|OTHER||t-statistic|2.694||||0.012|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test a potential effect of study period on distancing effort.||||.012
73808879|NCT03535194|147168002|SUPERIORITY||LSMean Difference|3.46|STANDARD_ERROR_OF_MEAN|0.642|<|0.001|TWO_SIDED|95.0|2.2|4.72|||ANCOVA|||||4.72|2.20|<0.001
73808880|NCT03535194|147168003|SUPERIORITY||LSMean Difference|3.96|STANDARD_ERROR_OF_MEAN|0.711|<|0.001|TWO_SIDED|95.0|2.56|5.35|||ANCOVA|||||5.35|2.56|<0.001
73808881|NCT03535194|147168004|SUPERIORITY||Risk Difference (RD)|65.0|||<|0.001|TWO_SIDED|95.0|59.3|70.8|||Cochran-Mantel-Haenszel|||||70.8|59.3|<0.001
73808882|NCT03535194|147168006|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.255||0.826|TWO_SIDED|95.0|-4.96|3.96|||ANCOVA|||||3.96|-4.96|0.826
73808883|NCT03535194|147168008|NON_INFERIORITY|10% non-inferiority margin was used.|Risk Difference (RD)|3.3|||<|0.0001|TWO_SIDED|95.0|-1.4|7.9|||Cochran-Mantel-Haenszel|||||7.9|-1.4|<0.0001
73808884|NCT03535194|147168009|NON_INFERIORITY|10% non-inferiority margin was used.|Risk Difference (RD)|1.6|||<|0.0001|TWO_SIDED|95.0|-3.4|6.6|||Cochran-Mantel-Haenszel|||||6.6|-3.4|<0.0001
73808885|NCT00979875|147168045|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.08|||<|0.0001|TWO_SIDED|90.0|1.7|2.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||2.55|1.70|<0.0001
73808886|NCT00979875|147168045|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|5.26|||<|0.0001|TWO_SIDED|90.0|3.88|7.12||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||7.12|3.88|<0.0001
73808887|NCT00979875|147168045|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|4.14|||<|0.0001|TWO_SIDED|90.0|3.05|5.6||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||5.60|3.05|<0.0001
73808888|NCT00979875|147168046|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-38.93|||<|0.0001|TWO_SIDED|90.0|-53.31|-24.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-24.55|-53.31|<0.0001
73808889|NCT00979875|147168046|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-26.43||||0.0032|TWO_SIDED|90.0|-40.81|-12.05||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-12.05|-40.81|0.0032
73808890|NCT00979875|147168046|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-42.14|||<|0.0001|TWO_SIDED|90.0|-56.53|-27.76||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-27.76|-56.53|<0.0001
73808891|NCT01869699|147168113|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.002|TWO_SIDED|95.0|-0.76|-0.18|||ANCOVA|||We estimated that 20 patients per group would provide 80% power for detecting a difference in means of 0.6 degrees Celsius, with a pooled SD of 0.67 degrees, using a two group t test and a two sided alpha level of 0.05. A previous RCT of IV acetaminophen in healthy male volunteers with induced fever found a core temperature difference of 0.60 degrees with a common SD of 0.67 degrees Celsius.||-0.18|-0.76|0.002
73808892|NCT01869699|147168114|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.03|TWO_SIDED|95.0|-10.0|-1.0|||ANCOVA|||||-1|-10|0.03
73808893|NCT01869699|147168115|SUPERIORITY||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-25.0|-8.0|||ANCOVA|||||-8|-25|<0.001
73808894|NCT01869699|147168116|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.42|TWO_SIDED|95.0|-4.0|12.0|||ANCOVA|||||12|-4|0.42
73808895|NCT01869699|147168117|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.002|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||||-0.3|-1|0.002
73808896|NCT01869699|147168118|SUPERIORITY||Mean Difference (Final Values)|-24.0||||0.001|TWO_SIDED|95.0|-38.0|-10.0|||ANCOVA|||||-10|-38|0.001
73808897|NCT01869699|147168119|SUPERIORITY||Mean Difference (Final Values)|-8.0||||0.02|TWO_SIDED|95.0|-15.0|-1.0|||ANCOVA|||||-1|-15|0.02
73808898|NCT00732758|147168120|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||ANCOVA|adjusting for baseline 25(OH)D, race, BMI, diet vitamin D, gender, pubertal status, and sunlight exposure.||||||0.003
73808899|NCT00732758|147168121|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|unadjusted p-values||||||0.51
73808900|NCT00732758|147168122|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
73808901|NCT00732758|147168123|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||t-test, 2 sided|||||||0.35
73808902|NCT01508130|147168136|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.08||||0.6451|TWO_SIDED|95.0|0.78|1.49|||Wald residual chi-square test||Due to the non-interventional study design, the Cox model included a propensity score as a covariate (incorporated important demographics and baseline characteristics) to account for the potential imbalance between treatment groups.|||1.49|0.78|0.6451
73808903|NCT01508130|147168136|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.02||||0.8826|TWO_SIDED|95.0|0.78|1.34|||Wald residual chi-square test||Without Propensity Score as a Covariate.|||1.34|0.78|0.8826
73808904|NCT01508130|147168137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.7695|TWO_SIDED|95.0|0.58|1.49|||Multiple Logistic Regression||A multiple logistic regression model including a propensity score as a covariate (incorporated important demographics and baseline characteristics) was used for the treatment comparison.|||1.49|0.58|0.7695
73808905|NCT01508130|147168137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.2594|TWO_SIDED|95.0|0.84|1.92|||Multiple Logistic Regression||Without Propensity Score as a Covariate|||1.92|0.84|0.2594
73808906|NCT01508130|147168144|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.9156|TWO_SIDED|95.0|0.64|1.64|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.|||1.64|0.64|0.9156
73808907|NCT01508130|147168145|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.5649|TWO_SIDED|95.0|0.57|1.36|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.|||1.36|0.57|0.5649
73808908|NCT01252563|147168168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
73808909|NCT01252563|147168168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
73808910|NCT01252563|147168168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
73808911|NCT01252563|147168168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
73808912|NCT01252563|147168169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
73808913|NCT01252563|147168169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
73808914|NCT01252563|147168169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
73808915|NCT01252563|147168169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
73808916|NCT01252563|147168172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Complication. The null hypothesis was that there was no difference between participants with complication(s) and participants without complication in the frequency of treatment-related adverse events."||||<0.001
73808917|NCT01252563|147168173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis was that there was no difference between male and female in the frequency of treatment-related adverse events."||||<0.001
73808918|NCT01252563|147168174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||Chi-squared|||"The risk factor tested was angina pectoris as a complication. The null hypothesis was that there was no difference between participants with angina pectoris and participants without angina pectoris in the frequency of treatment-related adverse events."||||0.036
73808919|NCT01252563|147168175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||"The risk factor tested was dyslipidaemia as a complication. The null hypothesis was that there was no difference between participants with dyslipidaemia and participants without dyslipidaemia in the frequency of treatment-related adverse events."||||0.020
73808920|NCT01252563|147168176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||Chi-squared|||"The risk factor tested was antihypertensive as a concomitant drug. The null hypothesis was that there was no difference between participants receiving antihypertensive and participants receiving no antihypertensive in the frequency of treatment-related adverse events."||||0.049
73808921|NCT01252563|147168177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||Chi-squared|||"The risk factor tested was ARB as a concomitant drug. The null hypothesis was that there was no difference between participants receiving ARB and participants receiving no ARB in the frequency of treatment-related adverse events."||||0.043
73808922|NCT01252563|147168178|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was diabetes mellitus as a complication. The null hypothesis was that there was no difference between participants with diabetes mellitus and participants without diabetes mellitus in the efficacy."||||<0.001
73808923|NCT01252563|147168179|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was chronic kidney disease as a complication. The null hypothesis was that there was no difference between participants with chronic kidney disease and participants without chronic kidney disease in the efficacy."||||<0.001
73808924|NCT01252563|147168180|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Chi-squared|||"The risk factor tested was myocardial infarction as a complication. The null hypothesis was that there was no difference between participants with myocardial infarction and participants without myocardial infarction in the efficacy."||||0.039
73808925|NCT01252563|147168181|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was metabolic syndrome as a complication. The null hypothesis was that there was no difference between participants with metabolic syndrome and participants without metabolic syndrome in the efficacy."||||<0.001
73808926|NCT01252563|147168182|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was ambulatory SBP at baseline. The null hypothesis was that there was no association between ambulatory SBP at baseline and the number of participants who achieved the target blood pressure specified in the guidelines."||||<0.001
73808927|NCT01252563|147168184|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
73808928|NCT01252563|147168184|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
73808929|NCT01252563|147168184|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
73808930|NCT01252563|147168184|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
73808931|NCT01252563|147168185|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
73808932|NCT01252563|147168185|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
73808933|NCT01252563|147168185|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
73808934|NCT01252563|147168185|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
73808935|NCT03421145|147168188|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73808936|NCT03421145|147168189|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73808937|NCT03421145|147168190|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73808938|NCT03421145|147168191|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73808939|NCT03421145|147168192|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73808940|NCT01820572|147168215|SUPERIORITY|difference between belatacept and CNI|Difference in proportions|0.9|||||TWO_SIDED|95.0|-8.6|10.4||||||||10.4|-8.6|
73808941|NCT01820572|147168216|SUPERIORITY|difference between belatacept and CNI|Difference in Proportions|-0.4|||||TWO_SIDED|95.0|-9.9|9.0||||||||9.0|-9.9|
73808942|NCT02105246|147168246|EQUIVALENCE|This analysis compared the proportion of eligible patients who participated in cardiac rehab after referral to home-based vs. referral to center-based programs.|Risk Ratio (RR)|0.98||||0.8|TWO_SIDED||||||Chi-squared|||Null hypothesis = no difference in proportion of patients who participate in cardiac rehab after referral to home-based vs. facility-based programs||||0.80
73808943|NCT02105246|147168247|NON_INFERIORITY|This analysis compared Baseline to 3-month change in 6-minute walk test distance among subjects who participated in home-based cardiac rehab vs. subjects who participated in center-based cardiac rehab|Median Difference (Final Values)|196.0|||<|0.001|TWO_SIDED|||||This comparison was unadjusted.|Wilcoxon (Mann-Whitney)|||Null hypothesis: 3-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.||||<0.001
73808944|NCT02105246|147168248|NON_INFERIORITY|This analysis compared 6-month change in 6-minute walk test distance among subjects who participated in home-based vs. center-based cardiac rehab.|Median Difference (Final Values)|159.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: 6-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.||||0.03
73808945|NCT00387010|147168252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.3223|TWO_SIDED|95.0|-4.64|1.54|||t-test, 2 sided|||||1.54|-4.64|0.3223
73808946|NCT04257032|147168371|OTHER||Ratio of geometric means (T/R) %|105.37|||||TWO_SIDED|90.0|97.94|113.35|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 9.9|Relative bioavailability||113.35|97.94|
73808947|NCT04257032|147168372|OTHER||Ratio of geometric means (T/R) %|114.5|||||TWO_SIDED|90.0|104.22|125.81|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 14.0|Relative bioavailability||125.81|104.22|
73808948|NCT04257032|147168373|OTHER||Ratio of geometric means (T/R) %|108.18|||||TWO_SIDED|90.0|100.26|116.73|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 11.3|Relative bioavailability||116.73|100.26|
73808949|NCT04257032|147168374|OTHER||Ratio of geometric means (T/R) %|108.89|||||TWO_SIDED|90.0|99.84|118.76|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 12.9|Relative bioavailability||118.76|99.84|
73808950|NCT04257032|147168375|OTHER||Ratio of geometric means (T/R) %|104.52|||||TWO_SIDED|90.0|97.34|112.23|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 10.6|Relative bioavailability||112.23|97.34|
73808951|NCT04257032|147168376|OTHER||Ratio of geometric means (T/R) %|108.42|||||TWO_SIDED|90.0|100.37|117.12|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 11.5|Relative bioavailability||117.12|100.37|
73808952|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|7.44||0.97|TWO_SIDED|95.0|-14.3|14.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and Baseline value as a covariate.~Least squares (LS) mean differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||14.9|-14.3|0.97
73808953|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|6.15||0.58|TWO_SIDED|95.0|-8.6|15.5|||ANCOVA|||||15.5|-8.6|0.58
73808954|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|6.13||0.33|TWO_SIDED|95.0|-6.1|18.0|||ANCOVA|||||18.0|-6.1|0.33
73808955|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|17.6|STANDARD_ERROR_OF_MEAN|6.2||0.005|TWO_SIDED|95.0|5.4|29.8|||ANCOVA|||||29.8|5.4|0.005
73895933|NCT03698591|147325430|OTHER||F-statistic|3.196||||0.085|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.085
73808956|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|18.2|STANDARD_ERROR_OF_MEAN|6.1||0.003|TWO_SIDED|95.0|6.2|30.2|||ANCOVA|||||30.2|6.2|0.003
73808957|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|21.7|STANDARD_ERROR_OF_MEAN|7.37||0.003|TWO_SIDED|95.0|7.2|36.1|||ANCOVA|||||36.1|7.2|0.003
73808958|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|26.3|STANDARD_ERROR_OF_MEAN|7.32|<|0.001|TWO_SIDED|95.0|11.9|40.7|||ANCOVA|||||40.7|11.9|<0.001
73808959|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.0|STANDARD_ERROR_OF_MEAN|8.46||0.2|TWO_SIDED|95.0|-5.6|27.6|||ANCOVA|||||27.6|-5.6|0.20
73808960|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|20.5|STANDARD_ERROR_OF_MEAN|8.43||0.015|TWO_SIDED|95.0|4.0|37.1|||ANCOVA|||||37.1|4.0|0.015
73808961|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.4|STANDARD_ERROR_OF_MEAN|8.43||0.008|TWO_SIDED|95.0|5.9|39.0|||ANCOVA|||||39.0|5.9|0.008
73808962|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.0|STANDARD_ERROR_OF_MEAN|7.32||0.003|TWO_SIDED|95.0|7.6|36.3|||ANCOVA|||||36.3|7.6|0.003
73808963|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.2|STANDARD_ERROR_OF_MEAN|8.46||0.009|TWO_SIDED|95.0|5.6|38.8|||ANCOVA|||||38.8|5.6|0.009
73808964|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|25.4|STANDARD_ERROR_OF_MEAN|7.35|<|0.001|TWO_SIDED|95.0|11.0|39.8|||ANCOVA|||||39.8|11.0|<0.001
73808965|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|27.9|STANDARD_ERROR_OF_MEAN|7.34|<|0.001|TWO_SIDED|95.0|13.5|42.3|||ANCOVA|||||42.3|13.5|<0.001
73808966|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|39.6|STANDARD_ERROR_OF_MEAN|7.39|<|0.001|TWO_SIDED|95.0|25.1|54.1|||ANCOVA|||||54.1|25.1|<0.001
73808967|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|40.2|STANDARD_ERROR_OF_MEAN|7.31|<|0.001|TWO_SIDED|95.0|25.8|54.5|||ANCOVA|||||54.5|25.8|<0.001
73808968|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|43.6|STANDARD_ERROR_OF_MEAN|8.42|<|0.001|TWO_SIDED|95.0|27.1|60.1|||ANCOVA|||||60.1|27.1|<0.001
73808969|NCT01340027|147168450|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|48.3|STANDARD_ERROR_OF_MEAN|8.35|<|0.001|TWO_SIDED|95.0|31.9|64.7|||ANCOVA|||||64.7|31.9|<0.001
73808970|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.366||0.062|TWO_SIDED|95.0|-1.4|0.03|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.03|-1.40|0.062
73895934|NCT03698591|147325430|OTHER||F-statistic|7.162||||0.013|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distancing effort. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.013
73895935|NCT03698591|147325431|OTHER||F-statistic|6.155||||0.019|TWO_SIDED|||||P-value corresponds to 3 way interaction. A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distraction performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.019
73895936|NCT03698591|147325431|OTHER||F-statistic|5.911||||0.021|TWO_SIDED|||||P-value corresponds to two-way interaction. A priori significance threshold of p \< .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distraction performance would not differ by study period. Within-subjects factors included task condition and study period.||||.021
73895937|NCT03698591|147325431|OTHER||t-statistic|1.282||||0.21|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distraction performance between study periods 1 and 2. The null hypothesis was that distraction performance would not differ by study period.||||.210
73895938|NCT03698591|147325431|OTHER||F-statistic|0.004||||0.948|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.948
73895939|NCT03698591|147325432|OTHER||F-statistic|0.031||||0.862|TWO_SIDED|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distraction self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.862
73895940|NCT03698591|147325432|OTHER||F-statistic|4.04||||0.054|TWO_SIDED|||||P-value corresponds to the main effect of study period. A priori threshold of p \< .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.||||.054
73895941|NCT03698591|147325432|OTHER||t-statistic|0.828||||0.415|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test the effect of study period on distraction effort.||||.415
73808971|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.302||0.91|TWO_SIDED|95.0|-0.63|0.56|||ANCOVA|||||0.56|-0.63|0.91
73895942|NCT03698591|147325432|OTHER||F-statistic|3.196||||0.085|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.085
73895943|NCT03698591|147325432|OTHER||F-statistic|0.396||||0.535|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distraction performance. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.535
73895944|NCT01675167|147325439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.98|||<|1e-05|TWO_SIDED|95.0|-1.32|-0.64||P value was adjusted using weighted z-test (CHW).|ANCOVA|||||-0.64|-1.32|<.00001
73895945|NCT01675167|147325440|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction||||<.0001
73895946|NCT01675167|147325440|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by Stratum (Dose Level)||Responders with ≥50% pain reduction||||<.0001
73895947|NCT01457352|147325470|SUPERIORITY|||||||0.2062|||||||Cochran-Mantel-Haenszel|||||||0.2062
73808972|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.302||0.2|TWO_SIDED|95.0|-0.98|0.2|||ANCOVA|||||0.20|-0.98|0.20
73808973|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.305||0.96|TWO_SIDED|95.0|-0.62|0.58|||ANCOVA|||||0.58|-0.62|0.96
73895948|NCT01457352|147325471|SUPERIORITY|||||||0.0485|||||||Mantel Haenszel|||||||0.0485
73895949|NCT04174365|147325472|SUPERIORITY||Least squares (LS) mean difference|-1.22||||0.4597|TWO_SIDED|95.0|-4.49|2.05|||Mixed model repeated measures(MMRM)|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction.|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction. Significance test was based on least-square means using a two-sided 0.05 level.|||2.05|-4.49|0.4597
73895950|NCT04174365|147325473|SUPERIORITY||LS mean difference|-0.07||||0.7315|TWO_SIDED|95.0|-0.46|0.32|||MMRM|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction.|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction. Significance test was based on least-square means using a two-sided 0.05 level.|||0.32|-0.46|0.7315
73808974|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.39|-0.22|||ANCOVA|||||-0.22|-1.39|0.007
73808975|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.363||0.016|TWO_SIDED|95.0|-1.59|-0.16|||ANCOVA|||||-0.16|-1.59|0.016
73808976|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.36||0.007|TWO_SIDED|95.0|-1.68|-0.27|||ANCOVA|||||-0.27|-1.68|0.007
73808977|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.417||0.91|TWO_SIDED|95.0|-0.87|0.77|||ANCOVA|||||0.77|-0.87|0.91
73808978|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.415||0.76|TWO_SIDED|95.0|-0.94|0.69|||ANCOVA|||||0.69|-0.94|0.76
73808979|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.416||0.99|TWO_SIDED|95.0|-0.82|0.81|||ANCOVA|||||0.81|-0.82|0.99
73808980|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.361||0.77|TWO_SIDED|95.0|-0.82|0.6|||ANCOVA|||||0.60|-0.82|0.77
73808981|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.417||0.058|TWO_SIDED|95.0|-1.61|0.03|||ANCOVA|||||0.03|-1.61|0.058
73808982|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.362||0.69|TWO_SIDED|95.0|-0.85|0.57|||ANCOVA|||||0.57|-0.85|0.69
73808983|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.362||0.17|TWO_SIDED|95.0|-1.21|0.21|||ANCOVA|||||0.21|-1.21|0.17
73808984|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.364||0.73|TWO_SIDED|95.0|-0.84|0.59|||ANCOVA|||||0.59|-0.84|0.73
73808985|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.361||0.012|TWO_SIDED|95.0|-1.62|-0.2|||ANCOVA|||||-0.20|-1.62|0.012
73808986|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.414||0.018|TWO_SIDED|95.0|-1.8|-0.17|||ANCOVA|||||-0.17|-1.80|0.018
73808987|NCT01340027|147168451|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.412||0.009|TWO_SIDED|95.0|-1.89|-0.28|||ANCOVA|||||-0.28|-1.89|0.009
73808988|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.46||0.51|TWO_SIDED|95.0|-1.0|0.82||Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals (CI) for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.||0.82|-1.00|0.51
73808989|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.355||0.21|TWO_SIDED|95.0|-0.57|0.83|||Stratified Rank ANCOVA|||||0.83|-0.57|0.21
73808990|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.361||0.89|TWO_SIDED|95.0|-0.68|0.74|||Stratified Rank ANCOVA|||||0.74|-0.68|0.89
73808991|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.365||0.001|TWO_SIDED|95.0|-1.06|0.38||P values were calculated from a pairwise comparison of the combination treatment groups vs solifenacin succinate 5 mg or placebo within the ANCOVA model.|Stratified Rank ANCOVA|||||0.38|-1.06|0.001
73808992|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.397||0.058|TWO_SIDED|95.0|-1.04|0.52|||Stratified Rank ANCOVA|||||0.52|-1.04|0.058
73808993|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.395||0.15|TWO_SIDED|95.0|-0.17|1.38|||Stratified Rank ANCOVA|||||1.38|-0.17|0.15
73808994|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.417||0.41|TWO_SIDED|95.0|-0.91|0.73|||Stratified Rank ANCOVA|||||0.73|-0.91|0.41
73808995|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.554||0.44|TWO_SIDED|95.0|-0.88|1.3|||Stratified Rank ANCOVA|||||1.30|-0.88|0.44
73808996|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.505||0.85|TWO_SIDED|95.0|-0.95|1.04|||Stratified Rank ANCOVA|||||1.04|-0.95|0.85
73808997|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.533||0.83|TWO_SIDED|95.0|-1.36|0.74|||Stratified Rank ANCOVA|||||0.74|-1.36|0.83
73808998|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.444||0.56|TWO_SIDED|95.0|-0.8|0.95|||Stratified Rank ANCOVA|||||0.95|-0.80|0.56
73808999|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.534||0.48|TWO_SIDED|95.0|-1.07|1.03|||Stratified Rank ANCOVA|||||1.03|-1.07|0.48
73809000|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.443||0.13|TWO_SIDED|95.0|-0.67|1.07|||Stratified Rank ANCOVA|||||1.07|-0.67|0.13
73809001|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.448||0.62|TWO_SIDED|2.0|-0.78|0.99|||Stratified Rank ANCOVA|||||0.99|-0.78|0.62
73809002|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.454||0.34|TWO_SIDED|95.0|-1.16|0.63|||Stratified Rank ANCOVA|||||0.63|-1.16|0.34
73809003|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.472||0.24|TWO_SIDED|95.0|-1.12|0.74|||Stratified Rank ANCOVA|||||0.74|-1.12|0.24
73809004|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|0.475||0.88|TWO_SIDED|95.0|-0.26|1.61|||Stratified Rank ANCOVA|||||1.61|-0.26|0.88
73809005|NCT01340027|147168452|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.494||0.83|TWO_SIDED|95.0|-0.99|0.95|||Stratified Rank ANCOVA|||||0.95|-0.99|0.83
73809006|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29||||0.42|TWO_SIDED|95.0|0.69|2.39|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.39|0.69|0.42
73809007|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.48|TWO_SIDED|95.0|0.72|2.0|||Regression, Logistic|||||2.00|0.72|0.48
73809008|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11||||0.69|TWO_SIDED|95.0|0.67|1.83|||Regression, Logistic|||||1.83|0.67|0.69
73809009|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.95|TWO_SIDED|95.0|0.61|1.69|||Regression, Logistic|||||1.69|0.61|0.95
73809010|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.91||||0.015|TWO_SIDED|95.0|1.14|3.21|||Regression, Logistic|||||3.21|1.14|0.015
73809011|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.06||||0.023|TWO_SIDED|95.0|1.11|3.84|||Regression, Logistic|||||3.84|1.11|0.023
73809012|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||0.16|TWO_SIDED|95.0|0.84|2.84|||Regression, Logistic|||||2.84|0.84|0.16
73809013|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.73|TWO_SIDED|95.0|0.45|1.76|||Regression, Logistic|||||1.76|0.45|0.73
73809014|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||0.7|TWO_SIDED|95.0|0.45|1.72|||Regression, Logistic|||||1.72|0.45|0.70
73809015|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.26|TWO_SIDED|95.0|0.74|2.99|||Regression, Logistic|||||2.99|0.74|0.26
73809016|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.69|TWO_SIDED|95.0|0.63|2.04|||Regression, Logistic|||||2.04|0.63|0.69
73809017|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.29|TWO_SIDED|95.0|0.73|2.89|||Regression, Logistic|||||2.89|0.73|0.29
73809018|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.31|TWO_SIDED|95.0|0.75|2.45|||Regression, Logistic|||||2.45|0.75|0.31
73809019|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.45|TWO_SIDED|95.0|0.7|2.25|||Regression, Logistic|||||2.25|0.70|0.45
73809020|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.64|TWO_SIDED|95.0|0.64|2.07|||Regression, Logistic|||||2.07|0.64|0.64
73809021|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.16||||0.013|TWO_SIDED|95.0|1.18|3.94|||Regression, Logistic|||||3.94|1.18|0.013
73809022|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.017|TWO_SIDED|95.0|1.16|4.66|||Regression, Logistic|||||4.66|1.16|0.017
73809023|NCT01340027|147168455|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.74||||0.11|TWO_SIDED|95.0|0.88|3.45|||Regression, Logistic|||||3.45|0.88|0.11
73809024|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.64||||0.52|TWO_SIDED|95.0|0.16|2.56|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.56|0.16|0.52
73809025|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||0.48|TWO_SIDED|95.0|0.23|1.99|||Regression, Logistic|||||1.99|0.23|0.48
73809026|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.95||||0.93|TWO_SIDED|95.0|0.32|2.81|||Regression, Logistic|||||2.81|0.32|0.93
73809027|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.12||||0.013|TWO_SIDED|95.0|1.47|25.6|||Regression, Logistic|||||25.60|1.47|0.013
73809028|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.49||||0.031|TWO_SIDED|95.0|1.17|25.77|||Regression, Logistic|||||25.77|1.17|0.031
73809029|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.84||||0.059|TWO_SIDED|95.0|0.95|15.58|||Regression, Logistic|||||15.58|0.95|0.059
73809030|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.91||||0.36|TWO_SIDED|95.0|0.48|7.58|||Regression, Logistic|||||7.58|0.48|0.36
73809031|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.34||||0.26|TWO_SIDED|95.0|0.05|2.17|||Regression, Logistic|||||2.17|0.05|0.26
73809032|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.43||||0.33|TWO_SIDED|95.0|0.08|2.31|||Regression, Logistic|||||2.31|0.08|0.33
73809033|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.94|TWO_SIDED|95.0|0.17|6.68|||Regression, Logistic|||||6.68|0.17|0.94
73809034|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.44||||0.29|TWO_SIDED|95.0|0.09|2.02|||Regression, Logistic|||||2.02|0.09|0.29
73809035|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.15|TWO_SIDED|95.0|0.05|1.6|||Regression, Logistic|||||1.60|0.05|0.15
73809036|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.29||||0.11|TWO_SIDED|95.0|0.06|1.34|||Regression, Logistic|||||1.34|0.06|0.11
73809037|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41||||0.26|TWO_SIDED|95.0|0.09|1.89|||Regression, Logistic|||||1.89|0.09|0.26
73809038|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.67||||0.28|TWO_SIDED|95.0|0.44|16.17|||Regression, Logistic|||||16.17|0.44|0.28
73809039|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.39||||0.36|TWO_SIDED|95.0|0.37|15.46|||Regression, Logistic|||||15.46|0.37|0.36
73809040|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.56|TWO_SIDED|95.0|0.29|9.72|||Regression, Logistic|||||9.72|0.29|0.56
73809041|NCT01340027|147168457|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.83||||0.84|TWO_SIDED|95.0|0.15|4.76|||Regression, Logistic|||||4.76|0.15|0.84
73809042|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61||||0.48|TWO_SIDED|95.0|0.16|2.38|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.38|0.16|0.48
73809043|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74||||0.58|TWO_SIDED|95.0|0.25|2.17|||Regression, Logistic|||||2.17|0.25|0.58
73809044|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.93|TWO_SIDED|95.0|0.34|3.28|||Regression, Logistic|||||3.28|0.34|0.93
73809045|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.16||||0.023|TWO_SIDED|95.0|1.4|105.3|||Regression, Logistic|||||105.30|1.40|0.023
73809046|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.48||||0.042|TWO_SIDED|95.0|1.08|83.24|||Regression, Logistic|||||83.24|1.08|0.042
73809047|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.03||||0.047|TWO_SIDED|95.0|1.03|79.19|||Regression, Logistic|||||79.19|1.03|0.047
73809048|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.79||||0.23|TWO_SIDED|95.0|0.52|14.9|||Regression, Logistic|||||14.90|0.52|0.23
73809049|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1||||0.058|TWO_SIDED|95.0|0.01|1.08|||Regression, Logistic|||||1.08|0.01|0.058
73809050|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.18||||0.15|TWO_SIDED|95.0|0.02|1.87|||Regression, Logistic|||||1.87|0.02|0.15
73809051|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.55|TWO_SIDED|95.0|0.04|5.99|||Regression, Logistic|||||5.99|0.04|0.55
73809052|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.16||||0.11|TWO_SIDED|95.0|0.02|1.48|||Regression, Logistic|||||1.48|0.02|0.11
73809053|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1||||0.054|TWO_SIDED|95.0|0.01|1.05|||Regression, Logistic|||||1.05|0.01|0.054
73809054|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.12||||0.059|TWO_SIDED|95.0|0.01|1.08|||Regression, Logistic|||||1.08|0.01|0.059
73809055|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.17||||0.12|TWO_SIDED|95.0|0.02|1.58|||Regression, Logistic|||||1.58|0.02|0.12
73809056|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.64|TWO_SIDED|95.0|0.11|35.46|||Regression, Logistic|||||35.46|0.11|0.64
73809057|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||0.76|TWO_SIDED|95.0|0.09|27.42|||Regression, Logistic|||||27.42|0.09|0.76
73809058|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.79|TWO_SIDED|95.0|0.08|26.47|||Regression, Logistic|||||26.47|0.08|0.79
73809059|NCT01340027|147168458|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.55|TWO_SIDED|95.0|0.04|5.77|||Regression, Logistic|||||5.77|0.04|0.55
73809060|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.495||0.25|TWO_SIDED|95.0|-1.24|0.71||All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.||0.71|-1.24|0.25
73809061|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.383||0.35|TWO_SIDED|95.0|-0.7|0.81|||Stratified Rank ANCOVA|||||0.81|-0.70|0.35
73809062|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.371||1|TWO_SIDED|95.0|-0.74|0.72|||Stratified Rank ANCOVA|||||0.72|-0.74|1.0
73809063|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.377||0.003|TWO_SIDED|95.0|-1.08|0.41|||Stratified Rank ANCOVA|||||0.41|-1.08|0.003
73809064|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.413||0.12|TWO_SIDED|95.0|-1.04|0.59|||Stratified Rank ANCOVA|||||0.59|-1.04|0.12
73809065|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.405||0.24|TWO_SIDED|95.0|-0.21|1.38|||Stratified Rank ANCOVA|||||1.38|-0.21|0.24
73809066|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.435||0.54|TWO_SIDED|95.0|-0.94|0.78|||Stratified Rank ANCOVA|||||0.78|-0.94|0.54
73809067|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.59||0.95|TWO_SIDED|95.0|-1.1|1.22|||Stratified Rank ANCOVA|||||1.22|-1.10|0.95
73809068|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.552||0.74|TWO_SIDED|95.0|-1.11|1.07|||Stratified Rank ANCOVA|||||1.07|-1.11|0.74
73809069|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.57||0.89|TWO_SIDED|95.0|-1.43|0.82|||Stratified Rank ANCOVA|||||0.82|-1.43|0.89
73809070|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.487||0.82|TWO_SIDED|95.0|-0.96|0.96|||Stratified Rank ANCOVA|||||0.96|-0.96|0.82
73809071|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.593||0.58|TWO_SIDED|95.0|-1.44|0.9|||Stratified Rank ANCOVA|||||0.90|-1.44|0.58
73809072|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.5||0.46|TWO_SIDED|95.0|-0.93|1.04|||Stratified Rank ANCOVA|||||1.04|-0.93|0.46
73809073|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.49||0.95|TWO_SIDED|95.0|-0.97|0.96|||Stratified Rank ANCOVA|||||0.96|-0.97|0.95
73809074|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.499||0.18|TWO_SIDED|95.0|-1.32|0.65|||Stratified Rank ANCOVA|||||0.65|-1.32|0.18
73809075|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.517||0.21|TWO_SIDED|95.0|-1.24|0.8|||Stratified Rank ANCOVA|||||0.80|-1.24|0.21
73809076|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.516||0.72|TWO_SIDED|95.0|-0.43|1.6|||Stratified Rank ANCOVA|||||1.60|-0.43|0.72
73809077|NCT01340027|147168459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.541||0.92|TWO_SIDED|95.0|-1.15|0.98|||Stratified Rank ANCOVA|||||0.98|-1.15|0.92
73809078|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.412||0.002|TWO_SIDED|95.0|-2.06|-0.45|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||-0.45|-2.06|0.002
73809079|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.34||0.16|TWO_SIDED|95.0|-1.15|0.19|||ANCOVA|||||0.19|-1.15|0.16
73809080|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-1.91|-0.57|||ANCOVA|||||-0.57|-1.91|<0.001
73809081|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.343||0.001|TWO_SIDED|95.0|-1.8|-0.46|||ANCOVA|||||-0.46|-1.80|0.001
73809082|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.338|<|0.001|TWO_SIDED|95.0|-2.03|-0.7|||ANCOVA|||||-0.70|-2.03|<0.001
73809083|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.409||0.017|TWO_SIDED|95.0|-1.78|-0.18|||ANCOVA|||||-0.18|-1.78|0.017
73809084|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.405||0.004|TWO_SIDED|95.0|-1.98|-0.39|||ANCOVA|||||-0.39|-1.98|0.004
73809085|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.469||0.53|TWO_SIDED|95.0|-0.63|1.22|||ANCOVA|||||1.22|-0.63|0.53
73809086|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.468||0.85|TWO_SIDED|95.0|-0.83|1.01|||ANCOVA|||||1.01|-0.83|0.85
73809087|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.468||0.84|TWO_SIDED|95.0|-1.01|0.83|||ANCOVA|||||0.83|-1.01|0.84
73809088|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.406||0.05|TWO_SIDED|95.0|0.0|1.59|||ANCOVA|||||1.59|-0.00|0.050
73809089|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.469||0.33|TWO_SIDED|95.0|-1.38|0.46|||ANCOVA|||||0.46|-1.38|0.33
73809090|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.407||0.44|TWO_SIDED|95.0|-0.48|1.12|||ANCOVA|||||1.12|-0.48|0.44
73809091|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.408||0.28|TWO_SIDED|95.0|-1.24|0.36|||ANCOVA|||||0.36|-1.24|0.28
73809092|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.41||0.42|TWO_SIDED|95.0|-1.14|0.47|||ANCOVA|||||0.47|-1.14|0.42
73895951|NCT03859973|147325507|OTHER||Mean Difference (Net)|-0.866||||0.3101|TWO_SIDED|95.0|-2.605|0.833|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value.||0.833|-2.605|0.3101
73809093|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.406||0.16|TWO_SIDED|95.0|-1.37|0.23|||ANCOVA|||||0.23|-1.37|0.16
73809094|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.467||0.7|TWO_SIDED|95.0|-1.1|0.73|||ANCOVA|||||0.73|-1.10|0.70
73809095|NCT01340027|147168460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.464||0.4|TWO_SIDED|95.0|-1.3|0.52|||ANCOVA|||||0.52|-1.30|0.40
73809096|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.079||0.062|TWO_SIDED|95.0|-0.3|0.01|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.01|-0.30|0.062
73809097|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.065||0.15|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|||||0.03|-0.22|0.15
73809098|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.065||0.007|TWO_SIDED|95.0|-0.3|-0.05|||ANCOVA|||||-0.05|-0.30|0.007
73809099|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.066||0.017|TWO_SIDED|95.0|-0.29|-0.03|||ANCOVA|||||-0.03|-0.29|0.017
73809100|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.35|-0.1|||ANCOVA|||||-0.10|-0.35|<0.001
73809101|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||||-0.11|-0.41|<0.001
73809102|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.077||0.07|TWO_SIDED|95.0|-0.29|0.01|||ANCOVA|||||0.01|-0.29|0.070
73809103|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.15|TWO_SIDED|95.0|-0.05|0.31|||ANCOVA|||||0.31|-0.05|0.15
73809104|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.089||0.57|TWO_SIDED|95.0|-0.12|0.23|||ANCOVA|||||0.23|-0.12|0.57
73809105|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.089||0.89|TWO_SIDED|95.0|-0.16|0.19|||ANCOVA|||||0.19|-0.16|0.89
73809106|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.077||0.086|TWO_SIDED|95.0|-0.02|0.29|||ANCOVA|||||0.29|-0.02|0.086
73809107|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.88|TWO_SIDED|95.0|-0.19|0.16|||ANCOVA|||||0.16|-0.19|0.88
73809108|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.078||0.61|TWO_SIDED|95.0|-0.11|0.19|||ANCOVA|||||0.19|-0.11|0.61
73809109|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.078||0.58|TWO_SIDED|95.0|-0.2|0.11|||ANCOVA|||||0.11|-0.20|0.58
73809110|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.078||0.76|TWO_SIDED|95.0|-0.18|0.13|||ANCOVA|||||0.13|-0.18|0.76
73809111|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_DEVIATION|0.077||0.23|TWO_SIDED|95.0|-0.25|0.06|||ANCOVA|||||0.06|-0.25|0.23
73809112|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.089||0.15|TWO_SIDED|95.0|-0.3|0.05|||ANCOVA|||||0.05|-0.30|0.15
73809113|NCT01340027|147168461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.088||0.94|TWO_SIDED|95.0|-0.18|0.17|||ANCOVA|||||0.17|-0.18|0.94
73809114|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.33||0.29|TWO_SIDED|95.0|-0.99|0.3|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.30|-0.99|0.29
73809115|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.239||0.15|TWO_SIDED|95.0|-0.12|0.82|||ANCOVA|||||0.82|-0.12|0.15
73809116|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.248||0.99|TWO_SIDED|95.0|-0.48|0.49|||ANCOVA|||||0.49|-0.48|0.99
73809117|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.239||0.76|TWO_SIDED|95.0|-0.54|0.4|||ANCOVA|||||0.40|-0.54|0.76
73809118|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.238||0.3|TWO_SIDED|95.0|-0.71|0.22|||ANCOVA|||||0.22|-0.71|0.30
73809119|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.262||0.43|TWO_SIDED|95.0|-0.72|0.31|||ANCOVA|||||0.31|-0.72|0.43
73809120|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.296||0.4|TWO_SIDED|95.0|-0.83|0.33|||ANCOVA|||||0.33|-0.83|0.40
73809121|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.343||0.24|TWO_SIDED|95.0|-1.08|0.27|||ANCOVA|||||0.27|-1.08|0.24
73809122|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.34||0.36|TWO_SIDED|95.0|-0.98|0.36|||ANCOVA|||||0.36|-0.98|0.36
73809123|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.348||0.02|TWO_SIDED|95.0|-1.49|-0.13|||ANCOVA|||||-0.13|-1.49|0.020
73809124|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.293||0.011|TWO_SIDED|95.0|-1.33|-0.18|||ANCOVA|||||-0.18|-1.33|0.011
73809125|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.377||0.004|TWO_SIDED|95.0|-1.84|-0.36|||ANCOVA|||||-0.36|-1.84|0.004
73809126|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.301||0.18|TWO_SIDED|95.0|-1.0|0.19|||ANCOVA|||||0.19|-1.00|0.18
73809127|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.308||0.015|TWO_SIDED|95.0|-1.35|-0.14|||ANCOVA|||||-0.14|-1.35|0.015
73809128|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.301||0.006|TWO_SIDED|95.0|-1.41|-0.23|||ANCOVA|||||-0.23|-1.41|0.006
73809129|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.59|-0.41|||ANCOVA|||||-0.41|-1.59|<0.001
73809130|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.32||0.003|TWO_SIDED|95.0|-1.59|-0.33|||ANCOVA|||||-0.33|-1.59|0.003
73809131|NCT01340027|147168462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.348||0.004|TWO_SIDED|95.0|-1.68|-0.31|||ANCOVA|||||-0.31|-1.68|0.004
73809132|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.177||0.15|TWO_SIDED|95.0|-0.6|0.09|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.09|-0.60|0.15
73809133|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.146||0.78|TWO_SIDED|95.0|-0.33|0.25|||ANCOVA|||||0.25|-0.33|0.78
73809134|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.146||0.58|TWO_SIDED|95.0|-0.37|0.21|||ANCOVA|||||0.21|-0.37|0.58
73809135|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.147||0.6|TWO_SIDED|95.0|-0.37|0.21|||ANCOVA|||||0.21|-0.37|0.60
73809136|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.145||0.017|TWO_SIDED|95.0|-0.63|-0.06|||ANCOVA|||||-0.06|-0.63|0.017
73809137|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.176||0.16|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.10|-0.60|0.16
73809138|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.175||0.13|TWO_SIDED|95.0|-0.61|0.08|||ANCOVA|||||0.08|-0.61|0.13
73809139|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.201||0.81|TWO_SIDED|95.0|-0.35|0.44|||ANCOVA|||||0.44|-0.35|0.81
73809140|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.199||0.67|TWO_SIDED|95.0|-0.48|0.31|||ANCOVA|||||0.31|-0.48|0.67
73809141|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.77|TWO_SIDED|95.0|-0.33|0.45|||ANCOVA|||||0.45|-0.33|0.77
73809142|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.81||0.81|TWO_SIDED|95.0|-0.3|0.38|||ANCOVA|||||0.38|-0.30|0.81
73809143|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.201||0.3|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||||0.18|-0.60|0.30
73809144|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.174||0.99|TWO_SIDED|95.0|-0.34|0.34|||ANCOVA|||||0.34|-0.34|0.99
73809145|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.175||0.82|TWO_SIDED|95.0|-0.38|0.3|||ANCOVA|||||0.30|-0.38|0.82
73809146|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.175||0.84|TWO_SIDED|95.0|-0.38|0.31|||ANCOVA|||||0.31|-0.38|0.84
73809147|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.173||0.08|TWO_SIDED|95.0|-0.64|0.04|||ANCOVA|||||0.04|-0.64|0.080
73809148|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||||0.18|-0.60|0.30
73809149|NCT01340027|147168463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.199||0.26|TWO_SIDED|95.0|-0.62|0.17|||ANCOVA|||||0.17|-0.62|0.26
73809150|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.38|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.2|-0.5|0.38
73809151|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.85|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.85
73809152|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.024|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.024
73809153|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.005|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.005
73809154|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.003|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.003
73809155|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.004
73809156|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.15|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.15
73809157|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.99|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||||0.4|-0.4|0.99
73809158|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.67|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||||0.3|-0.5|0.67
73809159|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.44|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||||0.2|-0.5|0.44
73809160|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.88|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||||0.4|-0.3|0.88
73809161|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.53|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||||0.3|-0.5|0.53
73809162|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||1|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|1.0
73809163|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0.0|-0.6|0.084
73809164|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.03|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||||-0.0|-0.7|0.030
73809165|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.02|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.020
73809166|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.017|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.017
73809167|NCT01340027|147168464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.26|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||||0.2|-0.6|0.26
73809168|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.04|TWO_SIDED|95.0|1.04|4.95|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||4.95|1.04|0.040
73809169|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.1||||0.73|TWO_SIDED|95.0|0.63|1.92|||Regression, Logistic|||||1.92|0.63|0.73
73809170|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.82||||0.05|TWO_SIDED|95.0|1.0|3.3|||Regression, Logistic|||||3.30|1.00|0.050
73809171|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.21|TWO_SIDED|95.0|0.81|2.59|||Regression, Logistic|||||2.59|0.81|0.21
73809172|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02||||0.021|TWO_SIDED|95.0|1.11|3.66|||Regression, Logistic|||||3.66|1.11|0.021
73809173|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.19|TWO_SIDED|95.0|0.79|3.4|||Regression, Logistic|||||3.40|0.79|0.19
73809174|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.74|TWO_SIDED|95.0|0.57|2.19|||Regression, Logistic|||||2.19|0.57|0.74
73809175|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.57|TWO_SIDED|95.0|0.58|2.71|||Regression, Logistic|||||2.71|0.58|0.57
73809176|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.19|TWO_SIDED|95.0|0.77|3.64|||Regression, Logistic|||||3.64|0.77|0.19
73809177|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.86||||0.69|TWO_SIDED|95.0|0.41|1.79|||Regression, Logistic|||||1.79|0.41|0.69
73809178|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.9|TWO_SIDED|95.0|0.55|1.99|||Regression, Logistic|||||1.99|0.55|0.90
73809179|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.36||||0.048|TWO_SIDED|95.0|1.01|5.55|||Regression, Logistic|||||5.55|1.01|0.048
73809180|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.67|TWO_SIDED|95.0|0.6|2.22|||Regression, Logistic|||||2.22|0.60|0.67
73809181|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.07|TWO_SIDED|95.0|0.95|3.78|||Regression, Logistic|||||3.78|0.95|0.070
73809182|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.23|TWO_SIDED|95.0|0.77|2.98|||Regression, Logistic|||||2.98|0.77|0.23
73809183|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.11||||0.034|TWO_SIDED|95.0|1.06|4.19|||Regression, Logistic|||||4.19|1.06|0.034
73809184|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.2|TWO_SIDED|95.0|0.76|3.84|||Regression, Logistic|||||3.84|0.76|0.20
73809185|NCT01340027|147168465|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.68|TWO_SIDED|95.0|0.55|2.49|||Regression, Logistic|||||2.49|0.55|0.68
73809186|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.62|TWO_SIDED|95.0|0.64|2.12|||Regression, Logistic|||||2.12|0.64|0.62
73809187|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.25|TWO_SIDED|95.0|0.82|2.17|||Regression, Logistic|||||2.17|0.82|0.25
73809188|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.11|TWO_SIDED|95.0|0.91|2.41|||Regression, Logistic|||||2.41|0.91|0.11
73809189|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.81||||0.02|TWO_SIDED|95.0|1.1|2.97|||Regression, Logistic|||||2.97|1.10|0.020
73809190|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87||||0.012|TWO_SIDED|95.0|1.15|3.05|||Regression, Logistic|||||3.05|1.15|0.012
73809191|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.072|TWO_SIDED|95.0|0.95|3.1|||Regression, Logistic|||||3.10|0.95|0.072
73809192|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.29|TWO_SIDED|95.0|0.77|2.44|||Regression, Logistic|||||2.44|0.77|0.29
73809193|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.94|TWO_SIDED|95.0|0.49|1.93|||Regression, Logistic|||||1.93|0.49|0.94
73809194|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.8|TWO_SIDED|95.0|0.46|1.81|||Regression, Logistic|||||1.81|0.46|0.80
73809195|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.67|TWO_SIDED|95.0|0.59|2.28|||Regression, Logistic|||||2.28|0.59|0.67
73809196|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.55|1.8|||Regression, Logistic|||||1.80|0.55|1.0
73809197|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.66|TWO_SIDED|95.0|0.59|2.31|||Regression, Logistic|||||2.31|0.59|0.66
73809198|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.35|TWO_SIDED|95.0|0.73|2.4|||Regression, Logistic|||||2.40|0.73|0.35
73895952|NCT03859973|147325508|OTHER||Mean Difference (Net)|-1.051||||0.2309|TWO_SIDED|95.0|-2.778|0.676|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value.||0.676|-2.778|0.2309
73809199|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.19|TWO_SIDED|95.0|0.82|2.67|||Regression, Logistic|||||2.67|0.82|0.19
73809200|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.054|TWO_SIDED|95.0|0.99|3.28|||Regression, Logistic|||||3.28|0.99|0.054
73809201|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87||||0.038|TWO_SIDED|95.0|1.04|3.38|||Regression, Logistic|||||3.38|1.04|0.038
73809202|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.12|TWO_SIDED|95.0|0.87|3.39|||Regression, Logistic|||||3.39|0.87|0.12
73809203|NCT01340027|147168466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.36|TWO_SIDED|95.0|0.7|2.67|||Regression, Logistic|||||2.67|0.70|0.36
73809204|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.32|TWO_SIDED|95.0|0.06|2.43|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.43|0.06|0.32
73809205|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|95.0|0.21|2.61|||Regression, Logistic|||||2.61|0.21|0.65
73809206|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.54||||0.39|TWO_SIDED|95.0|0.13|2.19|||Regression, Logistic|||||2.19|0.13|0.39
73895953|NCT03859973|147325509|OTHER||Mean Difference (Net)|0.577||||0.5237|TWO_SIDED|95.0|-1.207|2.362|||ANCOVA||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Analysis of Covariance (ANCOVA) which included the following fixed effects: categorical factor of planned treatment, continuous covariate of baseline value, categorical factor of age group.||2.362|-1.207|0.5237
73809207|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41||||0.22|TWO_SIDED|95.0|0.1|1.67|||Regression, Logistic|||||1.67|0.10|0.22
73809208|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.22||||0.082|TWO_SIDED|95.0|0.04|1.22|||Regression, Logistic|||||1.22|0.04|0.082
73809209|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.36||||0.36|TWO_SIDED|95.0|0.04|3.2|||Regression, Logistic|||||3.20|0.04|0.36
73809210|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.51|TWO_SIDED|95.0|0.42|5.71|||Regression, Logistic|||||5.71|0.42|0.51
73809211|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.99|TWO_SIDED|95.0|0.19|5.36|||Regression, Logistic|||||5.36|0.19|0.99
73809212|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.96|TWO_SIDED|95.0|0.24|4.59|||Regression, Logistic|||||4.59|0.24|0.96
73809213|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.62||||0.57|TWO_SIDED|95.0|0.12|3.3|||Regression, Logistic|||||3.30|0.12|0.57
73809214|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||0.93|TWO_SIDED|95.0|0.28|3.95|||Regression, Logistic|||||3.95|0.28|0.93
73809215|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.42||||0.37|TWO_SIDED|95.0|0.06|2.79|||Regression, Logistic|||||2.79|0.06|0.37
73809216|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79||||0.74|TWO_SIDED|95.0|0.2|3.13|||Regression, Logistic|||||3.13|0.20|0.74
73809217|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.57||||0.46|TWO_SIDED|95.0|0.12|2.59|||Regression, Logistic|||||2.59|0.12|0.46
73809218|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.44||||0.28|TWO_SIDED|95.0|0.1|1.96|||Regression, Logistic|||||1.96|0.10|0.28
73809219|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.23||||0.11|TWO_SIDED|95.0|0.04|1.4|||Regression, Logistic|||||1.40|0.04|0.11
73809220|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.38||||0.4|TWO_SIDED|95.0|0.04|3.66|||Regression, Logistic|||||3.66|0.04|0.40
73809221|NCT01340027|147168467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.5|TWO_SIDED|95.0|0.39|6.85|||Regression, Logistic|||||6.85|0.39|0.50
73809222|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.47||0.21|TWO_SIDED|95.0|-8.0|1.7|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||1.7|-8.0|0.21
73809223|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.03||0.54|TWO_SIDED|95.0|-5.2|2.7|||ANCOVA|||||2.7|-5.2|0.54
73809224|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|2.03||0.016|TWO_SIDED|95.0|-8.9|-0.9|||ANCOVA|||||-0.9|-8.9|0.016
73809225|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|2.05||0.011|TWO_SIDED|95.0|-9.3|-1.2|||ANCOVA|||||-1.2|-9.3|0.011
73809226|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-10.7|-2.8|||ANCOVA|||||-2.8|-10.7|<0.001
73809227|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|2.43||0.005|TWO_SIDED|95.0|-11.6|-2.0|||ANCOVA|||||-2.0|-11.6|0.005
73809228|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|2.44||0.056|TWO_SIDED|95.0|-9.4|0.1|||ANCOVA|||||0.1|-9.4|0.056
73809229|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.81||0.56|TWO_SIDED|95.0|-7.1|3.9|||ANCOVA|||||3.9|-7.1|0.56
73809230|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.8||0.48|TWO_SIDED|95.0|-7.5|3.5|||ANCOVA|||||3.5|-7.5|0.48
73809231|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.13||0.13|TWO_SIDED|95.0|-9.8|1.2|||ANCOVA|||||1.2|-9.8|0.13
73809232|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.42||0.61|TWO_SIDED|95.0|-6.0|3.5|||ANCOVA|||||3.5|-6.0|0.61
73809233|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|2.81||0.12|TWO_SIDED|95.0|-9.9|1.2|||ANCOVA|||||1.2|-9.9|0.12
73895954|NCT03859973|147325510|OTHER||Mean Difference (Net)|-0.669||||0.642|TWO_SIDED|95.0|-3.51|2.172|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (baseline, Week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group.||2.172|-3.510|0.6420
73809234|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|2.44||0.31|TWO_SIDED|95.0|-7.3|2.3|||ANCOVA|||||2.3|-7.3|0.31
73809235|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|2.44||0.012|TWO_SIDED|95.0|-10.9|-1.3|||ANCOVA|||||-1.3|-10.9|0.012
73809236|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|2.46||0.008|TWO_SIDED|95.0|-11.3|-1.7|||ANCOVA|||||-1.7|-11.3|0.008
73809237|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.44||0.001|TWO_SIDED|95.0|-12.8|-3.2|||ANCOVA|||||-3.2|-12.8|0.001
73809238|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.78||0.004|TWO_SIDED|95.0|-13.5|-2.6|||ANCOVA|||||-2.6|-13.5|0.004
73809239|NCT01340027|147168468|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.79||0.035|TWO_SIDED|95.0|-11.4|-0.4|||ANCOVA|||||-0.4|-11.4|0.035
73809240|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.4|TWO_SIDED|95.0|0.63|3.2|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||3.20|0.63|0.40
73809241|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.89|TWO_SIDED|95.0|0.55|1.97|||Regression, Logistic|||||1.97|0.55|0.89
73809242|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.57|TWO_SIDED|95.0|0.63|2.33|||Regression, Logistic|||||2.33|0.63|0.57
73809243|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.36|TWO_SIDED|95.0|0.7|2.66|||Regression, Logistic|||||2.66|0.70|0.36
73809244|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.15|TWO_SIDED|95.0|0.83|3.32|||Regression, Logistic|||||3.32|0.83|0.15
73809245|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.31|TWO_SIDED|95.0|0.67|3.59|||Regression, Logistic|||||3.59|0.67|0.31
73809246|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.81|TWO_SIDED|95.0|0.42|1.95|||Regression, Logistic|||||1.95|0.42|0.81
73809247|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75||||0.19|TWO_SIDED|95.0|0.75|4.08|||Regression, Logistic|||||4.08|0.75|0.19
73809248|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.59|TWO_SIDED|95.0|0.56|2.77|||Regression, Logistic|||||2.77|0.56|0.59
73809249|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.97||||0.13|TWO_SIDED|95.0|0.83|4.71|||Regression, Logistic|||||4.71|0.83|0.13
73809250|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.2|TWO_SIDED|95.0|0.78|3.16|||Regression, Logistic|||||3.16|0.78|0.20
73809251|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.07|TWO_SIDED|95.0|0.94|5.34|||Regression, Logistic|||||5.34|0.94|0.070
73809252|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.17|TWO_SIDED|95.0|0.81|3.33|||Regression, Logistic|||||3.33|0.81|0.17
73809253|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.084|TWO_SIDED|95.0|0.92|3.92|||Regression, Logistic|||||3.92|0.92|0.084
73809254|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.14||||0.043|TWO_SIDED|95.0|1.02|4.48|||Regression, Logistic|||||4.48|1.02|0.043
73809255|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.61||||0.013|TWO_SIDED|95.0|1.22|5.58|||Regression, Logistic|||||5.58|1.22|0.013
73809256|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.43||||0.053|TWO_SIDED|95.0|0.99|5.97|||Regression, Logistic|||||5.97|0.99|0.053
73809257|NCT01340027|147168469|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.43||||0.39|TWO_SIDED|95.0|0.63|3.26|||Regression, Logistic|||||3.26|0.63|0.39
73809258|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.55||0.26|TWO_SIDED|95.0|-2.1|7.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||7.9|-2.1|0.26
73809259|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.1||0.38|TWO_SIDED|95.0|-2.3|6.0|||ANCOVA|||||6.0|-2.3|0.38
73809260|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differrence|4.8|STANDARD_ERROR_OF_MEAN|2.1||0.022|TWO_SIDED|95.0|0.7|8.9|||ANCOVA|||||8.9|0.7|0.022
73809261|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|2.12||0.01|TWO_SIDED|95.0|1.3|9.7|||ANCOVA|||||9.7|1.3|0.010
73809262|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|2.09||0.002|TWO_SIDED|95.0|2.3|10.5|||ANCOVA|||||10.5|2.3|0.002
73809263|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|2.52||0.008|TWO_SIDED|95.0|1.7|11.6|||ANCOVA|||||11.6|1.7|0.008
73809264|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|2.52||0.037|TWO_SIDED|95.0|0.3|10.2|||ANCOVA|||||10.2|0.3|0.037
73809265|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.9||0.5|TWO_SIDED|95.0|-7.7|3.7|||ANCOVA|||||3.7|-7.7|0.50
73809266|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.89||0.65|TWO_SIDED|95.0|-4.4|7.0|||ANCOVA|||||7.0|-4.4|0.65
73809267|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.88||0.25|TWO_SIDED|95.0|-2.4|8.9|||ANCOVA|||||8.9|-2.4|0.25
73809268|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|2.51||0.76|TWO_SIDED|95.0|-5.7|4.1|||ANCOVA|||||4.1|-5.7|0.76
73809269|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.91||0.47|TWO_SIDED|95.0|-3.6|7.8|||ANCOVA|||||7.8|-3.6|0.47
73809270|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|2.52||0.67|TWO_SIDED|95.0|-3.9|6.0|||ANCOVA|||||6.0|-3.9|0.67
73809271|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.52||0.11|TWO_SIDED|95.0|-0.9|9.0|||ANCOVA|||||9.0|-0.9|0.11
73809272|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.54||0.062|TWO_SIDED|95.0|-0.2|9.7|||ANCOVA|||||9.7|-0.2|0.062
73809273|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|2.52||0.025|TWO_SIDED|95.0|0.7|10.6|||ANCOVA|||||10.6|0.7|0.025
73809274|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.88||0.041|TWO_SIDED|95.0|0.2|11.5|||ANCOVA|||||11.5|0.2|0.041
73809275|NCT01340027|147168470|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|2.88||0.12|TWO_SIDED|95.0|-1.2|10.1|||ANCOVA|||||10.1|-1.2|0.12
73809276|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.92|TWO_SIDED|95.0|0.52|2.08|||Regression, Logistic|||"All statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.08|0.52|0.92
73809277|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.58|1.77|||Regression, Logistic|||||1.77|0.58|0.98
73809278|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.45|TWO_SIDED|95.0|0.7|2.23|||Regression, Logistic|||||2.23|0.70|0.45
73809279|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.24|TWO_SIDED|95.0|0.79|2.53|||Regression, Logistic|||||2.53|0.79|0.24
73809280|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.21||||0.012|TWO_SIDED|95.0|1.19|4.09|||Regression, Logistic|||||4.09|1.19|0.012
73809281|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.43||||0.32|TWO_SIDED|95.0|0.7|2.9|||Regression, Logistic|||||2.90|0.70|0.32
73809282|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.27|TWO_SIDED|95.0|0.72|3.14|||Regression, Logistic|||||3.14|0.72|0.27
73809283|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.064|TWO_SIDED|95.0|0.24|1.04|||Regression, Logistic|||||1.04|0.24|0.064
73809284|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.57|TWO_SIDED|95.0|0.59|2.61|||Regression, Logistic|||||2.61|0.59|0.57
73809285|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.55|TWO_SIDED|95.0|0.59|2.68|||Regression, Logistic|||||2.68|0.59|0.55
73809286|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11||||0.75|TWO_SIDED|95.0|0.58|2.13|||Regression, Logistic|||||2.13|0.58|0.75
73809287|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.72|TWO_SIDED|95.0|0.53|2.49|||Regression, Logistic|||||2.49|0.53|0.72
73809288|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.74|TWO_SIDED|95.0|0.58|2.15|||Regression, Logistic|||||2.15|0.58|0.74
73809289|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.34|TWO_SIDED|95.0|0.71|2.71|||Regression, Logistic|||||2.71|0.71|0.34
73809290|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.19|TWO_SIDED|95.0|0.8|3.07|||Regression, Logistic|||||3.07|0.80|0.19
73809291|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.45||||0.012|TWO_SIDED|95.0|1.22|4.94|||Regression, Logistic|||||4.94|1.22|0.012
73809292|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.59||||0.25|TWO_SIDED|95.0|0.72|3.47|||Regression, Logistic|||||3.47|0.72|0.25
73809293|NCT01340027|147168471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.21|TWO_SIDED|95.0|0.74|3.75|||Regression, Logistic|||||3.75|0.74|0.21
73809294|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.376||0.63|TWO_SIDED|95.0|-0.56|0.92|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.92|-0.56|0.63
73809295|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.31||0.56|TWO_SIDED|95.0|-0.43|0.79|||ANCOVA|||||0.79|-0.43|0.56
73809296|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.308||0.14|TWO_SIDED|95.0|-0.15|1.06|||ANCOVA|||||1.06|-0.15|0.14
73809297|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.313||0.027|TWO_SIDED|95.0|0.08|1.3|||ANCOVA|||||1.30|0.08|0.027
73809298|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.308||0.13|TWO_SIDED|95.0|-0.14|1.07|||ANCOVA|||||1.07|-0.14|0.13
73809299|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.371||0.049|TWO_SIDED|95.0|0.0|1.46|||ANCOVA|||||1.46|0.00|0.049
73809300|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|0.368||0.011|TWO_SIDED|95.0|0.22|1.66|||ANCOVA|||||1.66|0.22|0.011
73809301|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.428||0.7|TWO_SIDED|95.0|-0.67|1.01|||ANCOVA|||||1.01|-0.67|0.70
73809302|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.423||0.084|TWO_SIDED|95.0|-0.1|1.56|||ANCOVA|||||1.56|-0.10|0.084
73809303|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.66|STANDARD_ERROR_OF_MEAN|0.425||0.12|TWO_SIDED|95.0|-0.18|1.49|||ANCOVA|||||1.49|-0.18|0.12
73809304|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.369||0.36|TWO_SIDED|95.0|-0.39|1.06|||ANCOVA|||||1.06|-0.39|0.36
73809305|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.428||0.23|TWO_SIDED|95.0|-0.32|1.36|||ANCOVA|||||1.36|-0.32|0.23
73809306|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.371||0.16|TWO_SIDED|95.0|-0.21|1.25|||ANCOVA|||||1.25|-0.21|0.16
73809307|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.371||0.032|TWO_SIDED|95.0|0.07|1.52|||ANCOVA|||||1.52|0.07|0.032
73809308|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.373||0.006|TWO_SIDED|95.0|0.3|1.76|||ANCOVA|||||1.76|0.30|0.006
73809309|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.369||0.031|TWO_SIDED|95.0|0.07|1.52|||ANCOVA|||||1.52|0.07|0.031
73809310|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|0.423||0.012|TWO_SIDED|95.0|0.24|1.9|||ANCOVA|||||1.90|0.24|0.012
73809311|NCT01340027|147168479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.28|STANDARD_ERROR_OF_MEAN|0.421||0.002|TWO_SIDED|95.0|0.45|2.1|||ANCOVA|||||2.10|0.45|0.002
73809312|NCT04687072|147168480|SUPERIORITY||Difference in percentage|-3.5||||0.5081|TWO_SIDED|95.0|-14.7|7.0||The p-value was calculated using the Cochran-Mantel-Haenszel test used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentages and 95% confidence interval (CI) (Klingenberg approach) were presented.|||7.0|-14.7|0.5081
73809313|NCT04687072|147168481|SUPERIORITY||Location shift|0.0||||0.4925|TWO_SIDED|95.0|0.0|0.0||The p-value was calculated using the stratified Mann-Whitney test used in the hierarchical testing procedure.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||0.000|0.000|0.4925
73809314|NCT04687072|147168482|SUPERIORITY||Difference in percentage|-0.5||||0.9314|TWO_SIDED|95.0|-11.7|10.0||The p-value was calculated using the Cochran-Mantel-Haenszel test used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentages and 95% CI (Klingenberg approach) were presented.|||10.0|-11.7|0.9314
73809315|NCT04687072|147168483|SUPERIORITY||Difference in percentage|-1.7||||0.7379|TWO_SIDED|95.0|-12.4|8.2||The Cochran-Mantel-Haenszel test p-value was used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentage and 95% CI (Klingenberg approach) are presented.|||8.2|-12.4|0.7379
73809316|NCT04687072|147168484|OTHER||Difference in percentage|4.2|||||TWO_SIDED|95.0|-9.3|16.8|||||||The 95% Agresti-Min CIs are presented.|16.8|-9.3|
73809317|NCT04687072|147168485|SUPERIORITY||Location shift|0.0||||0.726|TWO_SIDED|95.0|0.0|0.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||0.000|0.000|0.7260
73809318|NCT04687072|147168486|OTHER||Difference in percentage|2.5|||||TWO_SIDED|95.0|-9.6|13.0|||||The 95% Agresti-Min CIs are presented.|||13.0|-9.6|
73809319|NCT04687072|147168489|SUPERIORITY||Location shift|0.0||||0.2929|TWO_SIDED|95.0|0.0|1.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||1.000|0.000|0.2929
73809320|NCT04687072|147168490|SUPERIORITY||Location shift|0.0||||0.1475|TWO_SIDED|95.0|0.0|1.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||1.000|0.000|0.1475
73809321|NCT04687072|147168491|SUPERIORITY||Location shift|0.0||||0.7677|TWO_SIDED|95.0|-2.0|2.0||The p-value was calculated using the stratified Mann-Whitney test used in the hierarchical testing procedure.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|WHO Classified Bleeding Event Grade ≥1||2.000|-2.000|0.7677
73809322|NCT04687072|147168492|OTHER||Difference in percentage|-1.2|||||TWO_SIDED|95.0|-11.8|7.3|||||The 95% Agresti-Min CIs are presented.|IWG Complete Response||7.3|-11.8|
73809323|NCT04687072|147168492|OTHER||Difference in percentage|8.5|||||TWO_SIDED|95.0|-4.6|20.2|||||The 95% Agresti-Min CIs are presented.|IWG Response||20.2|-4.6|
73809324|NCT04687072|147168492|OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-9.7|13.3|||||The 95% Agresti-Min CIs are presented.|Initial Response||13.3|-9.7|
73809325|NCT04687072|147168494|OTHER||Difference in percentage|-4.0|||||TWO_SIDED|95.0|-15.6|5.7|||||The 95% Agresti-Min CIs are presented.|||5.7|-15.6|
73809326|NCT00915876|147168504|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
73809327|NCT01662791|147168510|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Comparison between the groups for \>12 ppm.||||1.0
73809328|NCT01662791|147168511|SUPERIORITY_OR_OTHER|||||||0.235|||||||Chi-squared|||Comparison between groups for mobility sub-scale.||||0.235
73809329|NCT01662791|147168511|SUPERIORITY_OR_OTHER|||||||0.206|||||||Chi-squared|||Comparison between groups for activities of daily living sub-scale.||||0.206
73809330|NCT01662791|147168511|SUPERIORITY_OR_OTHER|||||||0.641|||||||Chi-squared|||Comparison between groups for emotional well-being sub-scale.||||0.641
73809331|NCT01662791|147168511|SUPERIORITY_OR_OTHER|||||||0.446|||||||Chi-squared|||Comparison between groups for stigma sub-scale.||||0.446
73809332|NCT01662791|147168511|SUPERIORITY_OR_OTHER|||||||0.466|||||||Chi-squared|||Comparison between groups for social support sub-scale.||||0.466
73809333|NCT01662791|147168511|SUPERIORITY_OR_OTHER|||||||0.205|||||||Chi-squared|||Comparison between groups for cognition sub-scale.||||0.205
73809334|NCT01662791|147168511|SUPERIORITY_OR_OTHER|||||||0.153|||||||Chi-squared|||Comparison between groups for communication sub-scale.||||0.153
73809335|NCT01662791|147168511|SUPERIORITY_OR_OTHER|||||||0.73|||||||Chi-squared|||Comparison between groups for bodily discomfort sub-scale.||||0.730
73809336|NCT01662791|147168511|SUPERIORITY_OR_OTHER|||||||0.334|||||||Chi-squared|||Comparison between groups for summary index sub-scale.||||0.334
73809337|NCT01662791|147168512|SUPERIORITY_OR_OTHER|||||||0.167|||||||McNemar|||Comparison in case group between baseline and 3 months for mobility sub-scale.||||0.167
73809338|NCT01662791|147168512|SUPERIORITY_OR_OTHER|||||||0.159|||||||McNemar|||Comparison in case group between baseline and 3 months for activities of daily living sub-scale.||||0.159
73809339|NCT01662791|147168512|SUPERIORITY_OR_OTHER|||||||0.041|||||||McNemar|||Comparison in case group between baseline and 3 months for emotional well-being sub-scale.||||0.041
73809340|NCT01662791|147168512|SUPERIORITY_OR_OTHER|||||||0.19|||||||McNemar|||Comparison in case group between baseline and 3 months for stigma sub-scale.||||0.190
73809341|NCT01662791|147168512|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|||Comparison in case group between baseline and 3 months for social support sub-scale.||||1.0
73809342|NCT01662791|147168512|SUPERIORITY_OR_OTHER|||||||0.16|||||||McNemar|||Comparison in case group between baseline and 3 months for cognition sub-scale.||||0.160
73809343|NCT01662791|147168512|SUPERIORITY_OR_OTHER|||||||0.276|||||||McNemar|||Comparison in case group between baseline and 3 months for communication sub-scale.||||0.276
73809344|NCT01662791|147168512|SUPERIORITY_OR_OTHER|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for bodily discomfort sub-scale.||||0.351
73809345|NCT01662791|147168512|SUPERIORITY_OR_OTHER|||||||0.186|||||||McNemar|||Comparison in case group between baseline and 3 months for summary index sub-scale.||||0.186
73809346|NCT01662791|147168513|SUPERIORITY_OR_OTHER|||||||0.303|||||||Chi-squared|||Comparison between groups for constipation sub-scale.||||0.303
73809347|NCT01662791|147168513|SUPERIORITY_OR_OTHER|||||||0.518|||||||Chi-squared|||Comparison between groups for dyspepsia sub-scale.||||0.518
73809348|NCT01662791|147168513|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared|||Comparison between groups for abdominal discomfort sub-scale.||||0.800
73809349|NCT01662791|147168513|SUPERIORITY_OR_OTHER|||||||0.736|||||||Chi-squared|||Comparison between groups for diarrhea sub-scale.||||0.736
73809350|NCT01662791|147168513|SUPERIORITY_OR_OTHER|||||||0.57|||||||Chi-squared|||Comparison between groups for GERD sub-scale.||||0.570
73809351|NCT01662791|147168513|SUPERIORITY_OR_OTHER|||||||0.394|||||||Chi-squared|||Comparison between groups for nausea and vomiting sub-scale.||||0.394
73809352|NCT01662791|147168514|SUPERIORITY_OR_OTHER|||||||0.056|||||||McNemar|||Comparison in case group between baseline and 3 months for constipation sub-scale.||||0.056
73809353|NCT01662791|147168514|SUPERIORITY_OR_OTHER|||||||0.38|||||||McNemar|||Comparison in case group between baseline and 3 months for dyspepsia sub-scale.||||0.380
73809354|NCT01662791|147168514|SUPERIORITY_OR_OTHER|||||||0.244|||||||McNemar|||Comparison in case group between baseline and 3 months for abdominal discomfort sub-scale.||||0.244
73809355|NCT01662791|147168514|SUPERIORITY_OR_OTHER|||||||0.279|||||||McNemar|||Comparison in case group between baseline and 3 months for diarrhea sub-scale.||||0.279
73809356|NCT01662791|147168514|SUPERIORITY_OR_OTHER|||||||0.554|||||||McNemar|||Comparison in case group between baseline and 3 months for GERD sub-scale.||||0.554
73809357|NCT01662791|147168514|SUPERIORITY_OR_OTHER|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for nausea and vomiting sub-scale.||||0.351
73809358|NCT01662791|147168515|SUPERIORITY_OR_OTHER|||||||0.872|TWO_SIDED||||||t-test, 1 sided|||Comparison between the two groups at baseline for depression||||0.872
73809359|NCT01662791|147168515|SUPERIORITY_OR_OTHER|||||||0.835|TWO_SIDED||||||t-test, 1 sided|||Comparison between the two groups at baseline for anxiety.||||0.835
73809360|NCT02572076|147168519|OTHER|Pilot study- no sample size was calculated|number of subjects with adequate cleansi|100.0|||||TWO_SIDED|95.0|66.0|100.0||||||patients had partial bowel preparation to mimic poor bowel cleansing before the colonoscopy procedure at baseline, MCS was used during the procedure to clean the colon.||100|66|
73809361|NCT06366087|147168538|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.7|||||TWO_SIDED|90.0|0.67|0.724|||Mixed Models Analysis||Bioequivalence will be considered met if the 90% CI of the ratio for AUCinf lies within 80.00 to 125.00%.|||0.724|0.670|
73809362|NCT06366087|147168539|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.67|||||TWO_SIDED|90.0|0.64|0.697|||Mixed Models Analysis||Bioequivalence will be considered met if the 90% CI of the ratio for AUCt lies within 80.00 to 125.00%.|||0.697|0.640|
73809363|NCT06366087|147168540|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.11|||||TWO_SIDED|90.0|0.088|0.136|||Mixed Models Analysis|||||0.136|0.088|
73809364|NCT06366087|147168541|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.15|||||TWO_SIDED|90.0|0.12|0.189|||Mixed Models Analysis|||||0.189|0.120|
73895955|NCT03032380|147325524|NON_INFERIORITY|The study hypothesis was that the all-cause mortality rate at Day 14 in participants who received cefiderocol would be non-inferior to that in participants who received high-dose meropenem. The margin of non-inferiority was 12.5%. Non-inferiority was concluded if the upper bound of the 2-sided 95% confidence interval for the difference in mortality at Day 14 between the 2 treatment groups (cefiderocol - meropenem) was smaller than 12.5%.|Treatment Difference|0.8||||0.002|TWO_SIDED|95.0|-6.6|8.2|||Cochran-Mantel-Haenszel||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 14 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||8.2|-6.6|0.0020
73895956|NCT03032380|147325525|SUPERIORITY||Treatment Difference|-1.4|||||TWO_SIDED|95.0|-13.5|10.7|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the eradication rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||10.7|-13.5|
73895957|NCT03032380|147325526|SUPERIORITY||Treatment Difference|-2.0|||||TWO_SIDED|95.0|-12.5|8.5|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||8.5|-12.5|
73809365|NCT06366087|147168542|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.26|||||TWO_SIDED|90.0|0.217|0.309|||Mixed Models Analysis|||||0.309|0.217|
73809366|NCT06366087|147168543|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.36|||||TWO_SIDED|90.0|0.318|0.416|||Mixed Models Analysis|||||0.416|0.318|
73809367|NCT06366087|147168544|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.44|||||TWO_SIDED|90.0|0.396|0.492|||Mixed Models Analysis|||||0.492|0.396|
73809368|NCT06366087|147168545|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.57|||||TWO_SIDED|90.0|0.532|0.608|||Mixed Models Analysis|||||0.608|0.532|
73809369|NCT06366087|147168546|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.57|||||TWO_SIDED|90.0|0.524|0.62|||Mixed Models Analysis|||||0.620|0.524|
73809370|NCT00860249|147168568|SUPERIORITY_OR_OTHER||||||<|0.017||95.0||||We used the Bonferroni calculation to adjust for the planned multiple comparisons among the three groups.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.||||<0.017
73809371|NCT00860249|147168569|SUPERIORITY_OR_OTHER||||||<|0.017||95.0||||We intended to use a Bonferroni calculation to adjust for multiple comparisons among study arms.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.||||<0.017
73809372|NCT00174967|147168570|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73809373|NCT00174967|147168570|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73895958|NCT03032380|147325527|OTHER||Treatment Difference|-0.3|||||TWO_SIDED|95.0|-8.8|8.2|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||8.2|-8.8|
73895959|NCT03032380|147325528|OTHER||Treatment Difference|-3.8|||||TWO_SIDED|95.0|-12.8|5.1|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||5.1|-12.8|
73895960|NCT03032380|147325529|OTHER||Treatment Difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||10.8|-10.9|
73895961|NCT03032380|147325530|OTHER||Treatment Difference|-12.4|||||TWO_SIDED|95.0|-24.4|-0.5|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||-0.5|-24.4|
73895962|NCT03032380|147325531|OTHER||Treatment Difference|-3.8|||||TWO_SIDED|95.0|-15.5|7.9|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||7.9|-15.5|
73895963|NCT03032380|147325532|OTHER||Treatment Difference|3.9|||||TWO_SIDED|95.0|-7.9|15.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||15.8|-7.9|
73895964|NCT03032380|147325533|OTHER||Treatment Difference|0.5|||||TWO_SIDED|95.0|-8.7|9.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 28 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||9.8|-8.7|
73895965|NCT03032380|147325534|OTHER||Treatment Difference|3.6|||||TWO_SIDED|95.0|-6.3|13.4|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at EOS based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||13.4|-6.3|
73895966|NCT03032380|147325535|SUPERIORITY|||||||0.9382|||||||t-test, 2 sided|||Comparison of Hospitalization time at test of cure||||0.9382
73895967|NCT03032380|147325535|SUPERIORITY|||||||0.6552|||||||t-test, 2 sided|||Comparison of hospitalization time at follow-up||||0.6552
73895968|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.216|||||TWO_SIDED|95.0|-1.0|0.57||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast||0.57|-1.00|
73895969|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29|||||TWO_SIDED|95.0|-0.53|1.11||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast||1.11|-0.53|
73895970|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.748|||||TWO_SIDED|95.0|-0.02|1.52||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast||1.52|-0.02|
73895971|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.207|||||TWO_SIDED|95.0|-2.01|-0.41||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast||-0.41|-2.01|
73895972|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.991|||||TWO_SIDED|95.0|0.18|1.81||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7 , pre-breakfast||1.81|0.18|
73895973|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.497|||||TWO_SIDED|95.0|0.66|2.34||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||2.34|0.66|
73895974|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.955|||||TWO_SIDED|95.0|1.16|2.75||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||2.75|1.16|
73895975|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.78|||||TWO_SIDED|95.0|-1.74|0.18||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast||0.18|-1.74|
73895976|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.188|||||TWO_SIDED|95.0|-0.81|1.19||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast||1.19|-0.81|
73895977|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.35|1.55||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast||1.55|-0.35|
73895978|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.069|||||TWO_SIDED|95.0|-2.05|-0.08||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast||-0.08|-2.05|
73895979|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.289|||||TWO_SIDED|95.0|-0.71|1.29||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||1.29|-0.71|
73895980|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.257|||||TWO_SIDED|95.0|0.22|2.29||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||2.29|0.22|
73895981|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.669|||||TWO_SIDED|95.0|0.68|2.65||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||2.65|0.68|
73895982|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.556|||||TWO_SIDED|95.0|-1.65|0.54||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours||0.54|-1.65|
73895983|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.745|||||TWO_SIDED|95.0|-0.4|1.89||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours||1.89|-0.40|
73895984|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.711|||||TWO_SIDED|95.0|-0.36|1.78||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours||1.78|-0.36|
73895985|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-2.15|0.09||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours||0.09|-2.15|
73895986|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.474|||||TWO_SIDED|95.0|-0.66|1.61||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours||1.61|-0.66|
73895987|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.775|||||TWO_SIDED|95.0|0.6|2.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours||2.95|0.60|
73895988|NCT01128621|147325571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.741|||||TWO_SIDED|95.0|0.63|2.86||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours||2.86|0.63|
73895989|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.195|||||TWO_SIDED|95.0|-17.17|17.56||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast||17.56|-17.17|
73895990|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.863|||||TWO_SIDED|95.0|-34.7|0.98||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast||0.98|-34.70|
73895991|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.46|||||TWO_SIDED|95.0|-23.04|12.12||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast||12.12|-23.04|
73895992|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.85|||||TWO_SIDED|95.0|-13.89|21.58||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast||21.58|-13.89|
73809374|NCT00174967|147168570|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73809375|NCT00174967|147168571|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73809376|NCT00174967|147168571|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73809377|NCT00174967|147168571|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73809378|NCT00174967|147168572|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73809379|NCT00174967|147168572|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73809380|NCT00174967|147168572|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73895993|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.655|||||TWO_SIDED|95.0|-21.7|14.39||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||14.39|-21.70|
73809381|NCT00174967|147168573|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73809382|NCT00174967|147168573|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73809383|NCT00174967|147168573|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
73809384|NCT00174967|147168574|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809385|NCT00174967|147168574|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809386|NCT00174967|147168574|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809387|NCT00174967|147168575|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809388|NCT00174967|147168575|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809389|NCT00174967|147168575|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809390|NCT00174967|147168576|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809391|NCT00174967|147168576|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809392|NCT00174967|147168576|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809393|NCT00174967|147168577|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73895994|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.712|||||TWO_SIDED|95.0|-39.25|-2.17||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||-2.17|-39.25|
73895995|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.31|||||TWO_SIDED|95.0|-27.63|9.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||9.01|-27.63|
73895996|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.649|||||TWO_SIDED|95.0|-19.43|12.14||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast||12.14|-19.43|
73895997|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.66|||||TWO_SIDED|95.0|-32.72|-0.6||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast||-0.60|-32.72|
73809394|NCT00174967|147168577|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809395|NCT00174967|147168577|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809396|NCT00174967|147168578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809397|NCT00174967|147168578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809398|NCT00174967|147168578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809399|NCT00174967|147168579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809400|NCT00174967|147168579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73809401|NCT00174967|147168579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
73895998|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.251|||||TWO_SIDED|95.0|-38.34|-6.16||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast||-6.16|-38.34|
73895999|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.59|||||TWO_SIDED|95.0|-20.69|11.51||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast||11.51|-20.69|
73896000|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.941|||||TWO_SIDED|95.0|-15.4|17.28||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||17.28|-15.40|
73809402|NCT04934189|147168581|OTHER||Mean Difference (Final Values)|0.295|STANDARD_DEVIATION|1.184||0.08|ONE_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.08
73809403|NCT04934189|147168582|OTHER||Mean Difference (Net)|0.417|STANDARD_DEVIATION|0.89||0.005|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month follow-up mean) was statistically different from the baseline mean.||||.005
73809404|NCT04934189|147168584|OTHER||Mean Difference (Net)|-0.103|STANDARD_DEVIATION|2.5||0.4|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||0.40
73809405|NCT04934189|147168585|OTHER||Mean Difference (Net)|-0.01|STANDARD_DEVIATION|2.08||0.49|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month follow-up) mean was statistically different from the baseline mean.||||.49
73809406|NCT04934189|147168587|OTHER||Mean Difference (Net)|0.195|STANDARD_DEVIATION|1.41||0.21|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.21
73809407|NCT04934189|147168588|OTHER||Mean Difference (Net)|0.019|STANDARD_DEVIATION|1.43||0.47|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.47
73809408|NCT04934189|147168590|OTHER||Mean Difference (Net)|0.175|STANDARD_DEVIATION|1.02||0.16|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.16
73809409|NCT04934189|147168591|OTHER||Mean Difference (Net)|0.0481|STANDARD_DEVIATION|0.926||0.38|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.38
73809410|NCT04934189|147168593|OTHER||Mean Difference (Net)|0.179|STANDARD_DEVIATION|2.73||0.35|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.35
73896001|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.07|||||TWO_SIDED|95.0|-28.82|4.68||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||4.68|-28.82|
73896002|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.662|||||TWO_SIDED|95.0|-34.72|-0.6||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||-0.60|-34.72|
73896003|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.101|||||TWO_SIDED|95.0|-44.0|5.8||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours||5.80|-44.00|
73809411|NCT04934189|147168594|OTHER||Mean Difference (Net)|-0.335|STANDARD_DEVIATION|2.05||0.17|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.17
73809412|NCT04934189|147168598|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for gender nonaffirmation was statistically different from the baseline mean.|t-test|2.18||||0.02|ONE_SIDED|||||A priori threshold for statistical significance was \<.05|t-test, 1 sided|||||||.02
73809413|NCT04934189|147168598|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for internalized transphobia was statistically different from the baseline mean.|t-test|1.29||||0.1|ONE_SIDED|||||A priori threshold for statistical significant was p \<.05|t-test, 1 sided|||||||.10
73809414|NCT04934189|147168598|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for identity nondisclosure was statistically different from the baseline mean.|t-test|0.17||||0.43|ONE_SIDED|||||A priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.43
73896004|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.976|||||TWO_SIDED|95.0|-53.56|-2.39||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours||-2.39|-53.56|
73896005|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.609|||||TWO_SIDED|95.0|-48.82|1.6||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours||1.60|-48.82|
73809415|NCT04934189|147168598|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for negative expectations was statistically different from the baseline mean.|t-test|-0.68||||0.25|ONE_SIDED|||||A priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.25
73809416|NCT04934189|147168598|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for community connection was statistically different from the baseline mean.|t-test|-0.36||||0.36|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.36
73809417|NCT04934189|147168598|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for pride was statistically different from the baseline mean.|t-test|-0.09||||0.47|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.47
73809418|NCT04934189|147168599|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for gender nonaffirmation was statistically different from the baseline mean.|t-test|3.76|||<|0.001|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided||||"A series of one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean for each of the five gender minority stress subscales measured. See below for T-scores and associated p-values for each statistical test.~Nonaffirmation (t = 3.76; p = .001) Internalized Transphobia (t = 2.01; p = .02) Negative Expectations (t = 2.06; p =.02) Community Connection (t = -0.82; p =.21) Pride (t = .01; p = .50 )"|||<.001
73809419|NCT04934189|147168599|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for internalized transphobia was statistically different from the baseline mean.|t-test|2.01||||0.02|ONE_SIDED|||||The a priori threshold for statistical significance is p \< .05|t-test, 1 sided|||||||.02
73809420|NCT04934189|147168599|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for identity nondisclosure was statistically different from the baseline mean.|t-test|1.61||||0.06|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.06
73809421|NCT04934189|147168599|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for negative expectations was statistically different from the baseline mean.|t-test|2.06||||0.02|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.02
73809422|NCT04934189|147168599|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for community connection was statistically different from the baseline mean.|t-test|-0.818||||0.21|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.21
73809423|NCT04934189|147168599|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for pride was statistically different from the baseline mean.|t-test|0.009||||0.5|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.50
73809424|NCT04934189|147168602|OTHER||Chi-squared|5.59||||0.04|TWO_SIDED|||||A priori threshold for statistical significance was p \<.05|Chi-squared|||For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting freedom from sexual victimization over a 6 month time period||||.04
73809425|NCT04934189|147168602|OTHER|For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting any exposure to nonpenetrative sexual assault over a 6 month time period|Chi-squared|0.21||||0.55|TWO_SIDED|||||A priori threshold for statistical significance was p \< .05|Chi-squared|||||||.55
73809426|NCT04934189|147168602|OTHER|For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting exposure to rape over a 6 month time period|Chi-squared|0.11||||0.59|TWO_SIDED|||||A priori threshold for statistical significance was p \< .05|Chi-squared|||||||.59
73809427|NCT04934189|147168604|OTHER||Mean Difference (Net)|-0.08|STANDARD_DEVIATION|1.68||0.38|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.38
73809428|NCT04934189|147168605|OTHER||Mean Difference (Net)|-0.265|STANDARD_DEVIATION|2.21||0.25|ONE_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month) mean was statistically different from the baseline mean.||||.25
73809429|NCT00908791|147168606|SUPERIORITY_OR_OTHER|||||||0.003|||||||McNemar|exact McNemar test for paired binary data.||||||0.003
73809430|NCT00908791|147168607|SUPERIORITY_OR_OTHER|||||||0.41|||||||McNemar|||||||0.41
73809431|NCT00908791|147168608|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0|||||bowker's test of symmetry|||||||0.48
73809432|NCT00908791|147168609|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|95.0|||||Sign test|||The Sign-Rank test for paired data.||||0.029
73809433|NCT00908791|147168610|SUPERIORITY_OR_OTHER|||||||0.62|||||||t-test, 2 sided|||||||0.62
73809434|NCT00908791|147168611|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Other|||||||>0.05
73809435|NCT00908791|147168612|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Other|||||||>0.05
73809436|NCT03192995|147168616|SUPERIORITY|||||||0.91|||||||Fisher Exact|||||||0.91
73809437|NCT03192995|147168617|SUPERIORITY|||||||0.53|||||||Fisher Exact|||||||0.53
73809438|NCT03192995|147168618|SUPERIORITY|||||||0.32|||||||Fisher Exact|||||||.32
73809439|NCT03192995|147168619|SUPERIORITY|||||||0.541|||||||Fisher Exact|||||||.541
73809440|NCT03192995|147168620|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.24|3.82||||||||3.82|0.24|
73809441|NCT01286168|147168623|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.02
73809442|NCT01286168|147168624|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.03
73809443|NCT01286168|147168625|SUPERIORITY_OR_OTHER|||||||0.003|||||||McNemar|||Antisepsis and Control sides were compared.||||0.003
73809444|NCT01286168|147168626|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.13
73809445|NCT01286168|147168627|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.45
73809446|NCT01286168|147168628|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.||||0.02
73809447|NCT01286168|147168628|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.||||0.02
73809448|NCT01286168|147168629|SUPERIORITY_OR_OTHER|||||||0.004|||||||Likelihood-ratio test|||Antisepsis and Control sides were compared. Due to zero events in the antisepsis side for this endpoint, p-value was derived from likelihood-ratio test comparing the intercept only model to the model with intercept and treatment side included.||||0.004
73809449|NCT01286168|147168630|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.||||0.003
73809450|NCT01286168|147168630|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.||||0.003
73809451|NCT02738879|147168663|NON_INFERIORITY|Hypothesis A: After 30 weeks, continuing sitagliptin is non-inferior relative to withdrawing sitagliptin on the change from baseline in A1C. Non-inferiority is declared if the upper bound of the two-sided 95% CI for the difference is less than 0.3%.|Between Group Difference in the LSM|-0.46|||||TWO_SIDED|95.0|-0.58|-0.34|||LDA|||A longitudinal data analysis (LDA) model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening. Least Squares Means = LSM||-0.34|-0.58|
73896006|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.094|||||TWO_SIDED|95.0|-22.34|28.53||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours||28.53|-22.34|
73809452|NCT02738879|147168663|SUPERIORITY|Hypothesis B: After 30 weeks, continuing sitagliptin results in a greater reduction of A1C relative to withdrawing sitagliptin.|Between Group Difference in the LSM|-0.46|||<|0.001|TWO_SIDED|95.0|-0.58|-0.34|||LDA|||A LDA model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-0.34|-0.58|< 0.001
73809453|NCT02738879|147168664|SUPERIORITY||Event Rate Ratio|0.73|||=|0.039|TWO_SIDED|95.0|0.54|0.98|||Negative Binomial Model|||Calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||0.98|0.54|= 0.039
73809454|NCT02738879|147168665|OTHER|95% CI|Between Group Difference in Percentages|-0.3|||||TWO_SIDED|95.0|-2.3|1.7|||Miettinen & Nurminen|||||1.7|-2.3|
73809455|NCT02738879|147168666|SUPERIORITY||Between Group Difference in Percentages|-4.1|||=|0.25|TWO_SIDED|95.0|-11.2|2.9|||Miettinen and Nurminen|||||2.9|-11.2|= 0.250
73809456|NCT02738879|147168667|SUPERIORITY||Between Group Difference in the LSM|-8.0|||=|0.016|TWO_SIDED|95.0|-14.6|-1.5|||LDA model|||The analysis is based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-1.5|-14.6|= 0.016
73809457|NCT02738879|147168668|SUPERIORITY||Event Rate Ratio|0.81|||=|0.041|TWO_SIDED|95.0|0.67|0.99|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||0.99|0.67|= 0.041
73809458|NCT02738879|147168669|SUPERIORITY||Event Rate Ratio|0.83|||=|0.473|TWO_SIDED|95.0|0.51|1.37|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||1.37|0.51|= 0.473
73809459|NCT02738879|147168670|SUPERIORITY||Between Group Difference in Percentages|-1.2|||=|0.624|TWO_SIDED|95.0|-6.2|3.7|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. Includes imputed events after participants discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.||3.7|-6.2|= 0.624
73809460|NCT02738879|147168671|SUPERIORITY||Between Group Difference in Percentages|18.8|||<|0.001|TWO_SIDED|95.0|11.6|25.7|||Miettinen and Nurminen|||||25.7|11.6|< 0.001
73809461|NCT02738879|147168672|SUPERIORITY||Between Group Difference in the LSM|-6.5|||=|0.02|TWO_SIDED|95.0|-11.9|-1.0|||LDA|||Analysis was based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-1.0|-11.9|= 0.020
73809462|NCT02738879|147168673|OTHER|95% CI|Between Group Difference in Percentages|-2.1|||||TWO_SIDED|95.0|-9.1|5.0|||Miettinen & Nurminen|||||5.0|-9.1|
73896007|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.194|||||TWO_SIDED|95.0|-48.07|3.69||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours||3.69|-48.07|
73809463|NCT02738879|147168674|SUPERIORITY||Event Rate Ratio|0.76|||=|0.394|TWO_SIDED|95.0|0.4|1.44|||Negative Binomial Model|||The analysis was calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||1.44|0.40|= 0.394
73896008|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.07|||||TWO_SIDED|95.0|-57.66|-4.48||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours||-4.48|-57.66|
73896009|NCT01128621|147325572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.703|||||TWO_SIDED|95.0|-52.98|-0.42||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours||-0.42|-52.98|
73809464|NCT02738879|147168675|SUPERIORITY||Between Group Difference in Percentages|-1.2|||=|0.74|TWO_SIDED|95.0|-8.2|5.8|||Miettinen and Nurminen|||The analysis included imputed events after participants discontinued from the study medication, using a Gamma frailty model. Proportions and difference in proportions were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The bootstrap method was used to obtain the CI and p-value.||5.8|-8.2|= 0.740
73809465|NCT02738879|147168676|SUPERIORITY||Between Group Difference in Percentages|-0.7|||=|0.712|TWO_SIDED|95.0|-4.7|3.2|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The analysis included imputed events after subjects discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.||3.2|-4.7|= 0.712
73809466|NCT02738879|147168677|SUPERIORITY||Between Group Difference in Percentages|5.3|||=|0.03|TWO_SIDED|95.0|0.5|10.1|||Miettinen and Nurminen|||||10.1|0.5|= 0.030
73809467|NCT01730534|147168694|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.172||95.0|0.84|1.03|||Regression, Cox|||||1.03|0.84|0.172
73809468|NCT01730534|147168695|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.005||95.0|0.73|0.95|||Regression, Cox|||||0.95|0.73|0.005
73809469|NCT01730534|147168696|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.001||95.0|0.67|0.87|||Regression, Cox|||||0.87|0.67|<0.001
73809470|NCT01730534|147168697|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.198||95.0|0.82|1.04|||Regression, Cox|||||1.04|0.82|0.198
73896010|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.5|0.5||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7||0.50|-1.50|
73809471|NCT01895608|147168698|OTHER|non-parametric statistic: Mann-Whitney U test for independent samples||||||0.562|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.562
73809472|NCT01895608|147168698|OTHER|||||||0.414|||||||Wilcoxon (Mann-Whitney)|non-parametric statistical analysis: Mann Whitney U Test for independent samples||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.414
73809473|NCT01895608|147168699|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.181
73809474|NCT01895608|147168699|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||1.000
73809475|NCT01895608|147168700|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||1.000
73809476|NCT01895608|147168700|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.662|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.662
73809477|NCT01895608|147168701|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.05
73809478|NCT01895608|147168701|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.171|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.171
73809479|NCT01895608|147168702|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.313|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.313
73809480|NCT01895608|147168702|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.852|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.852
73809481|NCT01895608|147168703|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.263|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.263
73809482|NCT01895608|147168703|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.181
73809483|NCT02833844|147168715|SUPERIORITY||treatment difference|-56.92|STANDARD_ERROR_OF_MEAN|2.36|<|0.0001|TWO_SIDED|95.0|-61.55|-52.28||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-52.28|-61.55|< 0.0001
73896011|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.513|||||TWO_SIDED|95.0|-0.51|1.54||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7||1.54|-0.51|
73896012|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.05|2.01||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7||2.01|0.05|
73896013|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.955|||||TWO_SIDED|95.0|-1.98|0.07||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||0.07|-1.98|
73809484|NCT02833844|147168716|SUPERIORITY||treatment difference|-75.2|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001|TWO_SIDED|95.0|-82.1|-68.4||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-68.4|-82.1|< 0.0001
73809485|NCT02833844|147168717|SUPERIORITY||treatment difference|65.4|||<|0.0001|TWO_SIDED|95.0|57.8|71.1||Based on Cochran-Mantel-Haenszel test stratified by statin use stratification factor. For testing, nonachievement was imputed for participants with a missing value.|Cochran-Mantel-Haenszel|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as reference.|Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.||71.1|57.8|< 0.0001
73809486|NCT02833844|147168718|SUPERIORITY||treatment difference|71.9|||<|0.0001|TWO_SIDED|95.0|65.7|76.7||Based on Cochran-Mantel-Haenszel test stratified by statin use stratification factor. For testing, nonachievement was imputed for participants with a missing value.|Cochran-Mantel-Haenszel|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as a reference.|Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.||76.7|65.7|< 0.0001
73809487|NCT02833844|147168719|SUPERIORITY||treatment difference|-50.94|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-54.88|-46.99||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-46.99|-54.88|< 0.0001
73809488|NCT02833844|147168720|SUPERIORITY||treatment difference|-47.73|STANDARD_ERROR_OF_MEAN|1.72|<|0.0001|TWO_SIDED|95.0|-51.11|-44.35||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-44.35|-51.11|< 0.0001
73809489|NCT02833844|147168721|SUPERIORITY||treatment difference|-38.12|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|-41.3|-34.94||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-34.94|-41.30|< 0.0001
73809490|NCT02833844|147168722|SUPERIORITY||treatment difference|-26.78|STANDARD_ERROR_OF_MEAN|3.76|<|0.0001|TWO_SIDED|95.0|-34.17|-19.4||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-19.40|-34.17|< 0.0001
73809491|NCT02833844|147168723|SUPERIORITY||treatment difference|-22.46|STANDARD_ERROR_OF_MEAN|4.36|<|0.0001|TWO_SIDED|95.0|-31.03|-13.88||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-13.88|-31.03|< 0.0001
73809492|NCT02833844|147168724|SUPERIORITY||treatment difference|8.36|STANDARD_ERROR_OF_MEAN|1.8|<|0.0001|TWO_SIDED|95.0|4.83|11.89||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||11.89|4.83|< 0.0001
73809493|NCT02833844|147168725|SUPERIORITY||treatment difference|-22.15|STANDARD_ERROR_OF_MEAN|4.01|<|0.0001|TWO_SIDED|95.0|-30.04|-14.26||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-14.26|-30.04|< 0.0001
73809494|NCT03369067|147168726|OTHER|||||||0.01||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.010
73809495|NCT03369067|147168726|OTHER|||||||0.089||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.089
73809496|NCT03369067|147168726|OTHER|||||||0.024||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.024
73809497|NCT03369067|147168727|OTHER|||||||0.095||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.095
73809498|NCT03369067|147168727|OTHER|||||||0.104||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.104
73809499|NCT03369067|147168727|OTHER|||||||0.042||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.042
73809500|NCT03369067|147168728|OTHER||||||<|0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||<0.001
73809501|NCT03369067|147168728|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809502|NCT03369067|147168728|OTHER|||||||0.065||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.065
73809503|NCT03369067|147168729|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73896014|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.454|||||TWO_SIDED|95.0|-0.59|1.5||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||1.50|-0.59|
73896015|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.468|||||TWO_SIDED|95.0|0.39|2.55||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||2.55|0.39|
73896016|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.985|||||TWO_SIDED|95.0|0.96|3.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||3.01|0.96|
73896017|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.312|||||TWO_SIDED|95.0|-1.38|0.76||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14||0.76|-1.38|
73896018|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.394|||||TWO_SIDED|95.0|-0.7|1.49||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14||1.49|-0.70|
73896019|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.875|||||TWO_SIDED|95.0|-0.18|1.93||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14||1.93|-0.18|
73896020|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.854|||||TWO_SIDED|95.0|-1.95|0.25||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||0.25|-1.95|
73896021|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.542|||||TWO_SIDED|95.0|-0.58|1.66||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||1.66|-0.58|
73896022|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.248|||||TWO_SIDED|95.0|0.09|2.4||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||2.40|0.09|
73896023|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.729|||||TWO_SIDED|95.0|0.63|2.83||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||2.83|0.63|
73896024|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.148|||||TWO_SIDED|95.0|-1.21|0.91||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14||0.91|-1.21|
73896025|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.737|||||TWO_SIDED|95.0|-0.34|1.81||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14||1.81|-0.34|
73896026|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.245|||||TWO_SIDED|95.0|0.21|2.28||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14||2.28|0.21|
73896027|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.623|||||TWO_SIDED|95.0|-1.71|0.46||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||0.46|-1.71|
73809504|NCT03369067|147168729|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73896028|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-0.62|1.57||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||1.57|-0.62|
73896029|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.36|||||TWO_SIDED|95.0|0.23|2.49||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||2.49|0.23|
73896030|NCT01128621|147325575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.869|||||TWO_SIDED|95.0|0.79|2.95||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||2.95|0.79|
73896031|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.619|||||TWO_SIDED|95.0|-59.25|2.01||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7||2.01|-59.25|
73896032|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-47.898|||||TWO_SIDED|95.0|-79.23|-16.56||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7||-16.56|-79.23|
73896033|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.665|||||TWO_SIDED|95.0|-55.53|6.2||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7||6.20|-55.53|
73896034|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.438|||||TWO_SIDED|95.0|-36.76|25.89||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||25.89|-36.76|
73896035|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.181|||||TWO_SIDED|95.0|-55.0|8.63||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||8.63|-55.00|
73896036|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.46|||||TWO_SIDED|95.0|-75.18|-9.74||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||-9.74|-75.18|
73896037|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.227|||||TWO_SIDED|95.0|-51.83|13.37||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||13.37|-51.83|
73896038|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.435|||||TWO_SIDED|95.0|-49.15|12.28||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14||12.28|-49.15|
73809505|NCT03369067|147168729|OTHER|||||||0.063||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.063
73896039|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-58.658|||||TWO_SIDED|95.0|-90.08|-27.24||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14||-27.24|-90.08|
73896040|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.006|||||TWO_SIDED|95.0|-67.96|-6.05||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14||-6.05|-67.96|
73896041|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.896|||||TWO_SIDED|95.0|-41.31|21.52||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||21.52|-41.31|
73896042|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.539|||||TWO_SIDED|95.0|-40.44|23.36||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||23.36|-40.44|
73896043|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.762|||||TWO_SIDED|95.0|-81.58|-15.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||-15.95|-81.58|
73896044|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.11|||||TWO_SIDED|95.0|-59.8|5.58||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||5.58|-59.80|
73896045|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.359|||||TWO_SIDED|95.0|-48.95|8.23||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14||8.23|-48.95|
73896046|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-53.712|||||TWO_SIDED|95.0|-82.92|-24.5||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14||-24.50|-82.92|
73896047|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.552|||||TWO_SIDED|95.0|-66.24|-8.86||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14||-8.86|-66.24|
73896048|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.963|||||TWO_SIDED|95.0|-37.2|21.27||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||21.27|-37.20|
73896049|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.397|||||TWO_SIDED|95.0|-42.1|17.3||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||17.30|-42.10|
73809506|NCT03369067|147168730|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809507|NCT03369067|147168730|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809508|NCT03369067|147168730|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809509|NCT03369067|147168731|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809510|NCT03369067|147168731|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809511|NCT03369067|147168731|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809512|NCT03369067|147168732|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809513|NCT03369067|147168732|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809514|NCT03369067|147168732|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809515|NCT03369067|147168733|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809516|NCT03369067|147168733|OTHER|||||||0.062||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.062
73809517|NCT03369067|147168733|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809518|NCT03369067|147168734|OTHER|||||||0.015||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.015
73809519|NCT03369067|147168734|OTHER|||||||0.199||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.199
73809520|NCT03369067|147168734|OTHER|||||||0.025||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.025
73809521|NCT03369067|147168735|OTHER|||||||0.059||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.059
73809522|NCT03369067|147168735|OTHER|||||||0.064||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.064
73809523|NCT03369067|147168735|OTHER|||||||0.017||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.017
73809524|NCT03369067|147168736|OTHER|||||||0.034||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.034
73809525|NCT03369067|147168736|OTHER|||||||0.074||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.074
73809526|NCT03369067|147168736|OTHER|||||||0.034||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.034
73809527|NCT03369067|147168737|OTHER|||||||0.023||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.023
73809528|NCT03369067|147168737|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809529|NCT03369067|147168737|OTHER|||||||0.016||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.016
73809530|NCT03369067|147168738|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809531|NCT03369067|147168738|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809532|NCT03369067|147168738|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809533|NCT03369067|147168739|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809534|NCT03369067|147168739|OTHER|||||||0.081||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.081
73809535|NCT03369067|147168739|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809536|NCT03369067|147168740|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809537|NCT03369067|147168740|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809538|NCT03369067|147168740|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809539|NCT03369067|147168741|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809540|NCT03369067|147168741|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809541|NCT03369067|147168741|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809542|NCT03369067|147168742|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809543|NCT03369067|147168742|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809544|NCT03369067|147168742|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809545|NCT03369067|147168743|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809546|NCT03369067|147168743|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809547|NCT03369067|147168743|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809548|NCT03369067|147168744|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809549|NCT03369067|147168744|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809550|NCT03369067|147168744|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809551|NCT03369067|147168745|OTHER|||||||0.124||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.124
73809552|NCT03369067|147168745|OTHER|||||||0.187||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.187
73809553|NCT03369067|147168745|OTHER|||||||0.04||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.040
73809554|NCT03369067|147168746|OTHER|||||||0.108||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.108
73809555|NCT03369067|147168746|OTHER|||||||0.053||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.053
73809556|NCT03369067|147168746|OTHER|||||||0.01||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.010
73809557|NCT03369067|147168747|OTHER|||||||0.08||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.080
73809558|NCT03369067|147168747|OTHER|||||||0.038||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.038
73809559|NCT03369067|147168747|OTHER|||||||0.016||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.016
73809560|NCT03369067|147168748|OTHER|||||||0.111||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.111
73809561|NCT03369067|147168748|OTHER|||||||0.13||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.130
73809562|NCT03369067|147168748|OTHER|||||||0.017||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.017
73809563|NCT03369067|147168749|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809564|NCT03369067|147168749|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809565|NCT03369067|147168749|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809566|NCT03369067|147168750|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809567|NCT03369067|147168750|OTHER|||||||0.044||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.044
73809568|NCT03369067|147168750|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809569|NCT03369067|147168751|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809570|NCT03369067|147168751|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809571|NCT03369067|147168751|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809572|NCT03369067|147168752|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809573|NCT03369067|147168752|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809574|NCT03369067|147168752|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809575|NCT03369067|147168753|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809576|NCT03369067|147168753|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809577|NCT03369067|147168753|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809578|NCT03369067|147168754|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809579|NCT03369067|147168754|OTHER|||||||0.141||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.141
73809580|NCT03369067|147168754|OTHER|||||||0.149||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.149
73809581|NCT03369067|147168755|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809582|NCT03369067|147168755|OTHER|||||||0.094||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.094
73809583|NCT03369067|147168755|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809584|NCT03369067|147168756|OTHER||||||<|0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||<0.001
73809585|NCT03369067|147168756|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809586|NCT03369067|147168756|OTHER|||||||0.033||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.033
73809587|NCT03369067|147168757|OTHER|||||||0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.001
73809588|NCT03369067|147168757|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809589|NCT03369067|147168757|OTHER|||||||0.111||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.111
73809590|NCT03369067|147168758|OTHER|||||||0.118||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.118
73896050|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.749|||||TWO_SIDED|95.0|-76.2|-15.3||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||-15.30|-76.20|
73809591|NCT03369067|147168758|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809592|NCT03369067|147168758|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809593|NCT03369067|147168759|OTHER|||||||0.116||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.116
73809594|NCT03369067|147168759|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809595|NCT03369067|147168759|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809596|NCT03369067|147168760|OTHER|||||||0.005||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.005
73809597|NCT03369067|147168760|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809598|NCT03369067|147168760|OTHER|||||||0.193||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.193
73809599|NCT03369067|147168761|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809600|NCT03369067|147168761|OTHER|||||||0.106||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.106
73809601|NCT03369067|147168761|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809602|NCT03369067|147168762|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809603|NCT03369067|147168762|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809604|NCT03369067|147168762|OTHER|||||||0.157||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.157
73809605|NCT03369067|147168763|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809606|NCT03369067|147168763|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809607|NCT03369067|147168763|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809608|NCT03369067|147168764|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809609|NCT03369067|147168764|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809610|NCT03369067|147168764|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809611|NCT03369067|147168765|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809612|NCT03369067|147168765|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809613|NCT03369067|147168765|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809614|NCT03369067|147168766|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809615|NCT03369067|147168766|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809616|NCT03369067|147168766|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809617|NCT03369067|147168767|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809618|NCT03369067|147168767|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73896051|NCT01128621|147325576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.59|||||TWO_SIDED|95.0|-59.82|0.64||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||0.64|-59.82|
73809619|NCT03369067|147168767|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
73809620|NCT03369067|147168768|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809621|NCT03369067|147168768|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809622|NCT03369067|147168768|OTHER|||||||0.073||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.073
73809623|NCT03369067|147168769|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809624|NCT03369067|147168769|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809625|NCT03369067|147168769|OTHER|||||||0.064||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.064
73809626|NCT03369067|147168770|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809627|NCT03369067|147168770|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809628|NCT03369067|147168770|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809629|NCT03369067|147168771|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809630|NCT03369067|147168771|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809631|NCT03369067|147168771|OTHER|||||||0.104||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.104
73809632|NCT03369067|147168772|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809633|NCT03369067|147168772|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809634|NCT03369067|147168772|OTHER|||||||0.198||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.198
73809635|NCT03369067|147168773|OTHER|||||||0.105||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.105
73809636|NCT03369067|147168773|OTHER|||||||0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.001
73809637|NCT03369067|147168773|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809638|NCT03369067|147168774|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809639|NCT03369067|147168774|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809640|NCT03369067|147168774|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
73809641|NCT02122770|147168817|SUPERIORITY||Geometric LS Mean Ratio|98.75|||||TWO_SIDED|90.0|82.6|118.05||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric least square (LS) means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||118.05|82.60|
73809642|NCT02122770|147168818|SUPERIORITY||Geometric LS Mean Ratio|110.21|||||TWO_SIDED|90.0|102.34|118.69||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||118.69|102.34|
73809643|NCT02122770|147168819|SUPERIORITY||Geometric LS Mean Ratio|110.66|||||TWO_SIDED|90.0|102.53|119.43||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||119.43|102.53|
73809644|NCT02122770|147168820|SUPERIORITY||Geometric LS Mean Ratio|113.05|||||TWO_SIDED|90.0|85.35|149.74||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||149.74|85.35|
73809645|NCT02122770|147168820|SUPERIORITY||Geometric LS Mean Ratio|159.55|||||TWO_SIDED|90.0|89.97|282.96||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||282.96|89.97|
73809646|NCT02122770|147168820|SUPERIORITY||Geometric LS Mean Ratio|77.26|||||TWO_SIDED|90.0|55.19|108.17||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||108.17|55.19|
73809647|NCT02122770|147168821|SUPERIORITY||Geometric LS Mean Ratio|121.57|||||TWO_SIDED|90.0|110.92|133.24||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||133.24|110.92|
73809648|NCT02122770|147168821|SUPERIORITY||Geometric LS Mean Ratio|130.16|||||TWO_SIDED|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||158.35|106.99|
73809649|NCT02122770|147168821|SUPERIORITY||Geometric LS Mean Ratio|101.36|||||TWO_SIDED|90.0|90.72|113.23||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||113.23|90.72|
73809650|NCT02122770|147168822|SUPERIORITY||Geometric LS Mean Ratio|122.95|||||TWO_SIDED|90.0|112.13|134.82||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||134.82|112.13|
73809651|NCT02122770|147168822|SUPERIORITY||Geometric LS Mean Ratio|130.16|||||TWO_SIDED|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||158.35|106.99|
73809652|NCT02122770|147168822|SUPERIORITY||Geometric LS Mean Ratio|100.89|||||TWO_SIDED|90.0|91.14|111.68||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||111.68|91.14|
73809653|NCT00459706|147168865|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority test was performed using the 95 percent (%) two-sided confidence interval (CI) of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI \> -1."|Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.71|1.5|||ANOVA|ANOVA=analysis of variance||Non-inferiority of autoinjector (AI) over prefilled syringe (PFS) was assessed on the primary endpoint. Hypothesis tested was H0: AI minus PFS less than or equal to (≤) -1. The alternate hypothesis was H1: AI minus PFS greater than (\>) -1.||1.50|0.71|<0.001
73809654|NCT00459706|147168866|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority test was performed using the 95% two-sided CI of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI \> -1."|Mean Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.85|1.64|||ANOVA|||"Non-inferiority of AI over PFS was assessed on the primary endpoint. The hypotheses tested was as follows:~H0: AI - PFS ≤ -1 H1: AI - PFS \> -1"||1.64|0.85|<0.001
73809655|NCT00459706|147168867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.058|TWO_SIDED|95.0|0.98|3.05|||GEE Model+Logit Link+Binomial Distributn|GEE=Generalized estimating equation Distribn=distribution||||3.05|0.98|0.058
73809656|NCT00459706|147168868|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.019|TWO_SIDED|95.0|1.12|3.43|||GEE Model+Logit Link+Binomial Distributn|||||3.43|1.12|0.019
73809657|NCT00459706|147168869|SUPERIORITY_OR_OTHER||Regression coefficient|0.11||||0.16|TWO_SIDED|95.0|-0.04|0.27|||Regression, Linear|||All categories||0.27|-0.04|0.160
73809658|NCT00459706|147168870|SUPERIORITY_OR_OTHER||Regression coefficients|-0.75||||0.001|TWO_SIDED|95.0|-1.2|-0.29|||Regression, Linear|||Female versus male (reference).||-0.29|-1.20|0.001
73809659|NCT00459706|147168871|SUPERIORITY_OR_OTHER||Regression coefficient|-0.18||||0.676|TWO_SIDED|95.0|-0.62|0.26|||Regression, Linear|||Participants at High School/Baccalaureate Level versus participants with only Reading/Writing Capacity (reference).||0.26|-0.62|0.676
73809660|NCT00459706|147168871|SUPERIORITY_OR_OTHER||Regression coefficient|0.0||||0.676|TWO_SIDED|95.0|-0.59|0.6|||Regression, Linear|||Participants at University Level versus participants with only Reading/Writing Capacity (reference).||0.60|-0.59|0.676
73809661|NCT00459706|147168872|SUPERIORITY_OR_OTHER||Regression coefficient|-0.28||||0.02|TWO_SIDED|95.0|-0.52|-0.05|||Regression, Linear|||All categories||-0.05|-0.52|0.020
73809662|NCT00459706|147168873|SUPERIORITY_OR_OTHER||Regression coefficient|-0.35||||0.008|TWO_SIDED|95.0|-0.61|-0.09|||Regression, Linear|||All categories||-0.09|-0.61|0.008
73809663|NCT00459706|147168874|SUPERIORITY_OR_OTHER||Regression coefficient|0.17||||0.03|TWO_SIDED|95.0|0.02|0.32|||Regression, Linear|||All categories||0.32|0.02|0.030
73809664|NCT00459706|147168875|SUPERIORITY_OR_OTHER||Regression coefficient|-0.6||||0.006|TWO_SIDED|95.0|-1.03|-0.18|||Regression, Linear|||Self-injection Experience versus No Self-injection Experience (reference).||-0.18|-1.03|0.006
73809665|NCT00459706|147168876|SUPERIORITY_OR_OTHER||Regression coefficient|0.06||||0.278|TWO_SIDED|95.0|-0.05|0.18|||Regression, Linear|||All categories||0.18|-0.05|0.278
73809666|NCT00459706|147168877|SUPERIORITY_OR_OTHER||Regression coefficient|0.03||||0.749|TWO_SIDED|95.0|-0.15|0.21|||Regression, Linear|||All categories||0.21|-0.15|0.749
73809667|NCT00459706|147168878|SUPERIORITY_OR_OTHER||Regression coefficient|-0.08||||0.105|TWO_SIDED|95.0|-0.18|0.02|||Regression, Linear|||All categories||0.02|-0.18|0.105
73809668|NCT00459706|147168879|SUPERIORITY_OR_OTHER||Regression coefficient|0.01||||0.819|TWO_SIDED|95.0|-0.1|0.12|||Regression, Linear|||All categories||0.12|-0.10|0.819
73809669|NCT00459706|147168880|SUPERIORITY_OR_OTHER||Regression coefficient|-0.39||||0.012|TWO_SIDED|95.0|-0.69|-0.09|||Regression, Linear|||All categories, by 1-unit increments.||-0.09|-0.69|0.012
73809670|NCT00459706|147168881|SUPERIORITY_OR_OTHER||Regression coefficient|-0.1||||0.541|TWO_SIDED|95.0|-0.52|0.32|||Regression, Linear|||2 DMARDs versus 1 DMARD (reference).||0.32|-0.52|0.541
73809671|NCT00459706|147168881|SUPERIORITY_OR_OTHER||Regression coefficient|-0.14||||0.541|TWO_SIDED|95.0|-0.97|0.68|||Regression, Linear|||3 DMARDs versus 1 DMARD (reference).||0.68|-0.97|0.541
73809672|NCT00459706|147168881|SUPERIORITY_OR_OTHER||Regression coefficient|1.72||||0.541|TWO_SIDED|95.0|-0.82|4.25|||Regression, Linear|||At least 4 DMARDs versus 1 DMARD (reference).||4.25|-0.82|0.541
73809673|NCT00459706|147168882|SUPERIORITY_OR_OTHER||Regression coefficient|-0.15||||0.465|TWO_SIDED|95.0|-0.55|0.25|||Regression, Linear|||Prior Injection Experience versus No Prior Injection Experience (reference)||0.25|-0.55|0.465
73809674|NCT00459706|147168883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.29||0.154|TWO_SIDED|95.0|-0.97|0.15|||ANOVA|||||0.15|-0.97|0.154
73809675|NCT00459706|147168884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.17||0.212|TWO_SIDED|95.0|-0.12|0.56|||ANOVA|||||0.56|-0.12|0.212
73809676|NCT00459706|147168885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.19||0.965|TWO_SIDED|95.0|-0.39|0.37|||ANOVA|||||0.37|-0.39|0.965
73809677|NCT00459706|147168886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.19||0.519|TWO_SIDED|95.0|-0.25|0.5|||ANOVA|||||0.50|-0.25|0.519
73809678|NCT00459706|147168887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85|||<|0.001|TWO_SIDED|95.0|1.33|2.57|||GEE model+logit link+multinomial distrib|||Day 84||2.57|1.33|<0.001
73809679|NCT00459706|147168888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.007|TWO_SIDED|95.0|1.14|2.29|||GEE model+logit link+multinomial distrib|||||2.29|1.14|0.007
73809680|NCT00459706|147168889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.002|TWO_SIDED|95.0|1.26|2.92|||GEE model+logit link+multinomial distrib|||||2.92|1.26|0.002
73809681|NCT00459706|147168890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.001|TWO_SIDED|95.0|1.65|3.46|||GEE model+logit link+multinomial distrib|||||3.46|1.65|<0.001
73809682|NCT00459706|147168891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06|||<|0.001|TWO_SIDED|95.0|1.5|2.83|||GEE model+logit link+multinomial distrib|||||2.83|1.50|<0.001
73809683|NCT00459706|147168892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.44|2.78|||GEE model+logit link+multinomial distrib|||||2.78|1.44|<0.001
73809684|NCT00459706|147168893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.184|TWO_SIDED|95.0|0.9|1.72|||GEE model+logit link+multinomial distrib|||||1.72|0.90|0.184
73809685|NCT00459706|147168894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.106|TWO_SIDED|95.0|0.94|1.85|||GEE model+logit link+multinomial distrib|||||1.85|0.94|0.106
73809686|NCT00459706|147168895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.112|TWO_SIDED|95.0|0.93|1.96|||GEE model+logit link+multinomial distrib|||||1.96|0.93|0.112
73809687|NCT00459706|147168896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.21|2.24|||GEE model+logit link+multinomial distrib|||||2.24|1.21|0.002
73809688|NCT00459706|147168897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57|||<|0.001|TWO_SIDED|95.0|0.41|0.78|||GEE model+logit link+multinomial distrib|||||0.78|0.41|<0.001
73809689|NCT00459706|147168898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.022|TWO_SIDED|95.0|0.47|0.94|||GEE model+logit link+multinomial distrib|||||0.94|0.47|0.022
73809690|NCT00459706|147168899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.009|TWO_SIDED|95.0|0.46|0.89|||GEE model+logit link+multinomial distrib|||||0.89|0.46|0.009
73809691|NCT00459706|147168900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.007|TWO_SIDED|95.0|0.45|0.88|||GEE model+logit link+multinomial distrib|||||0.88|0.45|0.007
73809692|NCT00459706|147168901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.014|TWO_SIDED|95.0|0.47|0.92|||GEE model+logit link+multinomial distrib|||||0.92|0.47|0.014
73809693|NCT00459706|147168902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.88|||GEE model+logit link+multinomial distrib|||||2.88|1.53|<0.001
73809694|NCT00459706|147168903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.57|2.91|||GEE model+logit link+multinomial distrib|||||2.91|1.57|<0.001
73809695|NCT00459706|147168904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|2.23|4.25|||GEE model+logit link+multinomial distrib|||||4.25|2.23|<0.001
73809696|NCT00459706|147168905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88|||<|0.001|TWO_SIDED|95.0|1.35|2.62|||GEE model+logit link+multinomial distrib|||||2.62|1.35|<0.001
73809697|NCT00459706|147168906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.18|0.34|||GEE model+logit link+multinomial distrib|||||0.34|0.18|<0.001
73809698|NCT00459706|147168907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26|||<|0.001|TWO_SIDED|95.0|0.19|0.36|||GEE model+logit link+multinomial distrib|||||0.36|0.19|<0.001
73809699|NCT00459706|147168908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.2|0.36|||GEE model+logit link+multinomial distrib|||||0.36|0.20|<0.001
73809700|NCT00459706|147168909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.196|TWO_SIDED|95.0|0.61|1.11|||GEE model+logit link+multinomial distrib|||||1.11|0.61|0.196
73809701|NCT00459706|147168910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.001|TWO_SIDED|95.0|1.25|2.42|||GEE model+logit link+multinomial distrib|||||2.42|1.25|0.001
73809702|NCT00459706|147168911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.21|0.42|||GEE model+logit link+multinomial distrib|||||0.42|0.21|<0.001
73809703|NCT00459706|147168912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.29|0.56|||GEE model+logit link+multinomial distrib|||||0.56|0.29|<0.001
73809704|NCT00459706|147168913|SUPERIORITY_OR_OTHER|||||||0.896|TWO_SIDED||||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.896
73809705|NCT00459706|147168913|SUPERIORITY_OR_OTHER|||||||0.166|TWO_SIDED||||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.166
73809706|NCT00459706|147168914|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.069
73809707|NCT00459706|147168914|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.015
73809708|NCT00459706|147168915|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.069
73809709|NCT00459706|147168915|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.015
73809710|NCT00459706|147168916|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
73809711|NCT00459706|147168916|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
73809712|NCT00459706|147168917|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
73809713|NCT00459706|147168917|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
73809714|NCT00459706|147168918|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
73809715|NCT00459706|147168918|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
73809716|NCT00459706|147168919|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.023
73809717|NCT00459706|147168919|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
73809718|NCT00459706|147168920|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.038
73809719|NCT00459706|147168920|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
73809720|NCT00459706|147168921|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.018
73809721|NCT00459706|147168921|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.019
73809722|NCT00459706|147168922|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.049
73809723|NCT00459706|147168922|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.736
73809724|NCT00459706|147168923|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.033
73809725|NCT00459706|147168923|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.730
73809726|NCT00459706|147168924|SUPERIORITY_OR_OTHER|||||||0.838||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.838
73809727|NCT00459706|147168924|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.483
73809728|NCT00459706|147168925|SUPERIORITY_OR_OTHER|||||||0.466||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.466
73809729|NCT00459706|147168925|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.035
73809730|NCT00459706|147168926|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.784
73809731|NCT00459706|147168926|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.006
73809732|NCT00459706|147168927|SUPERIORITY_OR_OTHER|||||||0.843||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.843
73809733|NCT00459706|147168927|SUPERIORITY_OR_OTHER|||||||0.461||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.461
73809734|NCT00459706|147168928|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.150
73809735|NCT00459706|147168928|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.002
73809736|NCT00459706|147168929|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
73809737|NCT00459706|147168929|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
73809738|NCT00459706|147168930|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
73809739|NCT00459706|147168930|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
73809740|NCT00459706|147168931|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
73809741|NCT00459706|147168931|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
73809742|NCT00459706|147168932|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||<0.001
73809743|NCT00459706|147168932|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
73809744|NCT00373958|147168952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-3.6||||||95.0|-7.3|-0.1||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.1|-7.3|
73809745|NCT00373958|147168952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-5.5||||||95.0|-10.9|-0.1||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.1|-10.9|
73809746|NCT00373958|147168952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-7.9||||||95.0|-12.4|-4.0||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-4.0|-12.4|
73809747|NCT00373958|147168952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.7|3.5||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.5|-2.7|
73809748|NCT00373958|147168952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.6||||||95.0|-4.7|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-4.7|
73809749|NCT00373958|147168952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.4|3.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.4|-2.4|
73809750|NCT00373958|147168952|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-3.6||||||95.0|-8.5|1.2||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-8.5|
73809751|NCT00373958|147168953|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.8||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.80|0.57|
73809752|NCT00373958|147168953|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.74||||||95.0|0.61|0.89||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||0.89|0.61|
73809753|NCT00373958|147168953|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.62|0.85||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||0.85|0.62|
73809754|NCT00373958|147168953|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||0.86|0.60|
73896052|NCT00796445|147325591|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement.|Hazard Ratio (HR)|1.013||||0.8566|TWO_SIDED|95.0|0.879|1.169|||Regression, Cox|||At Final analysis (Month 30)||1.169|0.879|0.8566
73809755|NCT00373958|147168953|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.81||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||0.81|0.57|
73809756|NCT00373958|147168953|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|1.18||||||95.0|0.98|1.41||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||1.41|0.98|
73809757|NCT00373958|147168953|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.54|0.78||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||0.78|0.54|
73809758|NCT00373958|147168954|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|0.1||||||95.0|-2.9|3.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.||3.1|-2.9|
73809759|NCT00373958|147168954|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.6||||||95.0|-8.3|7.0||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||7.0|-8.3|
73896053|NCT00796445|147325591|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.111||||0.4821|TWO_SIDED|95.0|0.828|1.491|||Regression, Cox|||At Final analysis (Month 30)||1.491|0.828|0.4821
73896054|NCT00796445|147325591|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature|Hazard Ratio (HR)|0.915||||0.5375|TWO_SIDED|95.0|0.691|1.212|||Regression, Cox|||At Final analysis (Month 30)||1.212|0.691|0.5375
73896055|NCT00796445|147325592|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement|Hazard Ratio (HR)|1.023||||0.7534|TWO_SIDED|95.0|0.89|1.175|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.175|0.890|0.7534
73809760|NCT00373958|147168954|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.4||||||95.0|-4.3|3.5||||||For diphtheria toxoid the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||3.5|-4.3|
73809761|NCT00373958|147168954|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|1.7||||||95.0|-2.1|5.6||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 40.5 EU/mL threshold was calculated.||5.6|-2.1|
73809762|NCT00373958|147168954|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.9||||||95.0|-5.2|3.4||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 16.5 EU/mL threshold was calculated.||3.4|-5.2|
73809763|NCT00373958|147168954|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-2.1||||||95.0|-6.4|2.0||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 26 EU/mL threshold was calculated.||2.0|-6.4|
73809764|NCT00373958|147168955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.||1.7|-1.6|
73809765|NCT00373958|147168955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.6||||||95.0|-7.1|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0μg/mL threshold was calculated.||3.8|-7.1|
73809766|NCT00373958|147168955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|-0.8||||||95.0|-4.5|2.9||||||For Measles the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.||2.9|-4.5|
73809767|NCT00373958|147168955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|3.6||||||95.0|-4.7|11.9||||||For Mumps the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.||11.9|-4.7|
73809768|NCT00373958|147168955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|1.2||||||95.0|-4.4|6.9||||||For Rubella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥15 IU/mL threshold was calculated.||6.9|-4.4|
73809769|NCT00373958|147168955|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|4.8||||||95.0|-3.4|13.0||||||For Varicella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.09 I.V. threshold was calculated.||13.0|-3.4|
73809770|NCT00373958|147168956|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.75|1.17||||||For Haemophilus influenzae type b (PRP) the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.75|
73809771|NCT00373958|147168957|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.96|||||TWO_SIDED|95.0|0.85|1.08||||||For Measles the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.85|
73809772|NCT00373958|147168957|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.14||||||For Mumps the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.87|
73809773|NCT00373958|147168957|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01|||||TWO_SIDED|95.0|0.92|1.1||||||For Varicella the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.92|
73809774|NCT00373958|147168958|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78|||||TWO_SIDED|95.0|0.62|1.0||||||For Rubella the GMC ratio (13vPnC/7vPnC) was calculated||1.00|0.62|
73809775|NCT01552915|147168963|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-2.1|STANDARD_ERROR_OF_MEAN|1.15||0.0717|TWO_SIDED|95.0|-4.3|0.2|||mixed effects model for repeated measure|||||0.2|-4.3|0.0717
73809776|NCT01552915|147168963|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-12.2|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-15.1|-9.4|||mixed effects model for repeated measure|||||-9.4|-15.1|<0.0001
73809777|NCT01552915|147168963|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-10.1|STANDARD_ERROR_OF_MEAN|1.43|<|0.0001|TWO_SIDED|95.0|-13.0|-7.3|||mixed effects model for repeated measure|||||-7.3|-13.0|<0.0001
73809778|NCT01552915|147168964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6165|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6165
73809779|NCT01552915|147168964|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
73809780|NCT01552915|147168964|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
73809781|NCT03403751|147168981|SUPERIORITY|||||||0.649|||||||Chi-squared|||||||0.649
73809782|NCT03403751|147168984|SUPERIORITY|||||||0.871|||||||Chi-squared|||||||0.871
73809783|NCT03403751|147168985|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
73809784|NCT03403751|147168986|SUPERIORITY|||||||0.448|||||||Wilcoxon (Mann-Whitney)|||||||0.448
73809785|NCT03403751|147168987|SUPERIORITY|||||||0.579|||||||Wilcoxon (Mann-Whitney)|||||||0.579
73809786|NCT03403751|147168988|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
73809787|NCT03403751|147168991|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73809788|NCT03403751|147168992|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
73809789|NCT03403751|147168993|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73809790|NCT03403751|147168994|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
73809791|NCT02091986|147169019|SUPERIORITY_OR_OTHER|||||||0.006|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.006
73809792|NCT02091986|147169019|SUPERIORITY_OR_OTHER|||||||0.063|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.063
73809793|NCT02091986|147169019|SUPERIORITY_OR_OTHER|||||||0.373|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.373
73809794|NCT02091986|147169020|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.001
73809795|NCT02091986|147169020|SUPERIORITY_OR_OTHER|||||||0.195|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.195
73809796|NCT02091986|147169020|SUPERIORITY_OR_OTHER|||||||0.032|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.032
73809797|NCT02091986|147169021|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||<0.001
73809798|NCT02091986|147169021|SUPERIORITY_OR_OTHER|||||||0.005|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.005
73809799|NCT02091986|147169021|SUPERIORITY_OR_OTHER|||||||0.326|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.326
73809800|NCT02091986|147169022|SUPERIORITY_OR_OTHER|||||||0.276|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.276
73809801|NCT02091986|147169022|SUPERIORITY_OR_OTHER|||||||0.759|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.759
73809802|NCT02091986|147169022|SUPERIORITY_OR_OTHER|||||||0.165|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.165
73809803|NCT02091986|147169023|SUPERIORITY_OR_OTHER|||||||0.724|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.724
73809804|NCT02091986|147169023|SUPERIORITY_OR_OTHER|||||||0.909|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.909
73809805|NCT02091986|147169023|SUPERIORITY_OR_OTHER|||||||0.811|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.811
73809806|NCT02091986|147169024|SUPERIORITY_OR_OTHER|||||||0.134|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.134
73809807|NCT02091986|147169024|SUPERIORITY_OR_OTHER|||||||0.985|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.985
73809808|NCT02091986|147169024|SUPERIORITY_OR_OTHER|||||||0.128|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.128
73896056|NCT00796445|147325592|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.094||||0.5385|TWO_SIDED|95.0|0.821|1.457|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.457|0.821|0.5385
73809809|NCT02091986|147169025|SUPERIORITY_OR_OTHER|||||||0.684|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.684
73809810|NCT02091986|147169025|SUPERIORITY_OR_OTHER|||||||0.621|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.621
73809811|NCT02091986|147169025|SUPERIORITY_OR_OTHER|||||||0.929|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.929
73809812|NCT02091986|147169026|SUPERIORITY_OR_OTHER|||||||0.664|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.664
73809813|NCT02091986|147169026|SUPERIORITY_OR_OTHER|||||||0.747|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.747
73809814|NCT02091986|147169026|SUPERIORITY_OR_OTHER|||||||0.913|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.913
73809815|NCT02091986|147169027|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.015
73809816|NCT02091986|147169027|SUPERIORITY_OR_OTHER|||||||0.342|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.342
73809817|NCT02091986|147169027|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.138
73809818|NCT02091986|147169031|SUPERIORITY_OR_OTHER|||||||0.098|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.098
73809819|NCT02091986|147169031|SUPERIORITY_OR_OTHER|||||||0.367|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.367
73809820|NCT02091986|147169031|SUPERIORITY_OR_OTHER|||||||0.449|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.449
73809821|NCT02537431|147169038|OTHER||Mean|-54.18|||<|0.0001|TWO_SIDED|95.0|-68.64|-39.72||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-39.72|-68.64|< 0.0001
73809822|NCT02537431|147169039|OTHER||||||<|0.0001||||||The p-value is for testing the proportion of participants achieving the mean serum phosphorus levels above the LLN (2.5 mg/dL \[0.81 mmol/L\]) against 0% from the binomial test.|binomial test|||||||<0.0001
73809823|NCT02537431|147169040|OTHER||Mean|-32.21|||<|0.0001|TWO_SIDED|95.0|-40.25|-24.17||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-24.17|-40.25|<0.0001
73809824|NCT02537431|147169041|OTHER||Mean|-26.0||||0.0002|TWO_SIDED|95.0|-36.08|-15.91||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-15.91|-36.08|0.0002
73809825|NCT02537431|147169042|OTHER||Mean|-52.24||||0.0199|TWO_SIDED|95.0|-94.08|-10.41||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-10.41|-94.08|0.0199
73809826|NCT02537431|147169054|OTHER||Least Squares Mean (GEE)|107.75|||||TWO_SIDED|95.0|76.46|139.03|||||From the generalized estimation equation (GEE) model which includes change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 1||139.03|76.46|
73809827|NCT02537431|147169054|OTHER||LS Mean|48.41|||||TWO_SIDED|95.0|33.91|62.91|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 2||62.91|33.91|
73809828|NCT02537431|147169054|OTHER||LS Mean|13.58|||||TWO_SIDED|95.0|6.85|20.31|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 4||20.31|6.85|
73809829|NCT02537431|147169054|OTHER||LS Mean|-1.34|||||TWO_SIDED|95.0|-8.43|5.75|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 20||5.75|-8.43|
73809830|NCT02537431|147169054|OTHER||LS Mean|31.75|||||TWO_SIDED|95.0|21.49|42.0|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 21||42.00|21.49|
73809831|NCT02537431|147169054|OTHER||LS Mean|11.5|||||TWO_SIDED|95.0|3.54|19.46|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 22||19.46|3.54|
73809832|NCT02537431|147169054|OTHER||LS Mean|-3.04|||||TWO_SIDED|95.0|-12.62|6.55|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 24||6.55|-12.62|
73809833|NCT02537431|147169054|OTHER||LS Mean|-1.72||||0.6821|TWO_SIDED|95.0|-9.93|6.5|||GEE model||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 48||6.50|-9.93|0.6821
73809834|NCT02537431|147169054|OTHER||LS mean|-5.73|||||TWO_SIDED|95.0|-12.38|0.92|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 60||0.92|-12.38|
73809835|NCT02537431|147169054|OTHER||LS mean|3.36|||||TWO_SIDED|95.0|-4.45|11.18|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 70||11.18|-4.45|
73809836|NCT02537431|147169054|OTHER||LS mean|-5.55|||||TWO_SIDED|95.0|-11.22|0.13|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 72||0.13|-11.22|
73809837|NCT02537431|147169054|OTHER||LS mean|-5.55|||||TWO_SIDED|95.0|-11.35|0.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 84||0.26|-11.35|
73809838|NCT02537431|147169054|OTHER||LS mean|9.63|||||TWO_SIDED|95.0|1.33|17.94|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 94||17.94|1.33|
73809839|NCT02537431|147169054|OTHER||LS mean|-6.09|||||TWO_SIDED|95.0|-10.8|-1.38||||||Week 96||-1.38|-10.80|
73809840|NCT02537431|147169054|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-9.22|9.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 108||9.26|-9.22|
73809841|NCT02537431|147169054|OTHER||LS mean|1.45|||||TWO_SIDED|95.0|-6.77|9.68|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 120||9.68|-6.77|
73809842|NCT02537431|147169054|OTHER||LS mean|-1.69|||||TWO_SIDED|95.0|-5.6|2.21|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 132||2.21|-5.60|
73809843|NCT02537431|147169055|OTHER||LS Mean|0.1|||||TWO_SIDED|95.0|-0.15|0.35|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 12||0.35|-0.15|
73809844|NCT02537431|147169055|OTHER||LS Mean|-0.04|||||TWO_SIDED|95.0|-0.19|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 24||0.11|-0.19|
73809845|NCT02537431|147169055|OTHER||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.12|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 36||0.11|-0.12|
73809846|NCT02537431|147169055|OTHER||LS Mean|-0.04||||0.6021|TWO_SIDED|95.0|-0.19|0.11|||GEE model||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 48||0.11|-0.19|0.6021
73809847|NCT02537431|147169055|OTHER||LS mean|0.0|||||TWO_SIDED|95.0|-0.19|0.19|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 72||0.19|-0.19|
73809848|NCT02537431|147169055|OTHER||LS mean|-0.13|||||TWO_SIDED|95.0|-0.29|0.03|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 96||0.03|-0.29|
73809849|NCT02537431|147169055|OTHER||LS mean|-0.07|||||TWO_SIDED|95.0|-0.41|0.26|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|EOS II||0.26|-0.41|
73809850|NCT02537431|147169056|OTHER||LS Mean|1.76|||||TWO_SIDED|95.0|1.49|2.03|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 2||2.03|1.49|
73809851|NCT02537431|147169056|OTHER||LS Mean|0.78|||||TWO_SIDED|95.0|0.59|0.97|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 4||0.97|0.59|
73809852|NCT02537431|147169056|OTHER||LS Mean|0.58|||||TWO_SIDED|95.0|0.34|0.82|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 12||0.82|0.34|
73809853|NCT02537431|147169056|OTHER||LS Mean|0.87|||||TWO_SIDED|95.0|0.74|0.99|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 22||0.99|0.74|
73809854|NCT02537431|147169056|OTHER||LS Mean|0.44|||||TWO_SIDED|95.0|0.24|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 24||0.64|0.24|
73809855|NCT02537431|147169056|OTHER||LS Mean|0.2||||0.043|TWO_SIDED|95.0|0.01|0.38|||GEE model||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 48||0.38|0.01|0.0430
73809856|NCT02537431|147169056|OTHER||LS mean|0.3|||||TWO_SIDED|95.0|-0.04|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 60||0.64|-0.04|
73809857|NCT02537431|147169056|OTHER||LS mean|0.28|||||TWO_SIDED|95.0|0.03|0.52|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 72||0.52|0.03|
73809858|NCT02537431|147169056|OTHER||LS mean|0.39|||||TWO_SIDED|95.0|0.13|0.66|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 84||0.66|0.13|
73809859|NCT02537431|147169056|OTHER||LS mean|0.29|||||TWO_SIDED|95.0|0.1|0.48|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 96||0.48|0.10|
73809860|NCT02537431|147169056|OTHER||LS mean|0.21|||||TWO_SIDED|95.0|0.08|0.34|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|EOSII||0.34|0.08|
73809861|NCT02537431|147169057|OTHER||LS Mean|0.07|||||TWO_SIDED|95.0|0.06|0.08|||||From the GEE model, which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 2||0.08|0.06|
73809862|NCT02537431|147169057|OTHER||LS Mean|0.03|||||TWO_SIDED|95.0|0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 4||0.06|0.01|
73809863|NCT02537431|147169057|OTHER||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 12||0.04|-0.01|
73809864|NCT02537431|147169057|OTHER||LS Mean|0.04|||||TWO_SIDED|95.0|0.02|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 22||0.05|0.02|
73809865|NCT02537431|147169057|OTHER||LS Mean|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||Week 24||0.04|-0.02|
73809866|NCT02537431|147169057|OTHER||LS Mean|0.0||||0.8377|TWO_SIDED|95.0|-0.05|0.04|||GEE model||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 48||0.04|-0.05|0.8377
73809867|NCT02537431|147169057|OTHER||LS mean|0.03|||||TWO_SIDED|95.0|0.0|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 60||0.06|-0.00|
73809868|NCT02537431|147169057|OTHER||LS mean|-0.02|||||TWO_SIDED|95.0|-0.09|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 72||0.05|-0.09|
73809869|NCT02537431|147169057|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 84||0.06|-0.01|
73809870|NCT02537431|147169057|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-0.01|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 96||0.05|-0.01|
73809871|NCT02537431|147169057|OTHER||LS mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|EOSII||0.03|-0.01|
73809872|NCT02537431|147169058|OTHER||LS Mean|99.18|||||TWO_SIDED|95.0|76.83|121.53|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12||121.53|76.83|
73809873|NCT02537431|147169058|OTHER||LS Mean|104.33|||||TWO_SIDED|95.0|82.47|126.19|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24||126.19|82.47|
73809874|NCT02537431|147169058|OTHER||LS Mean|52.49|||<|0.0001|TWO_SIDED|95.0|29.84|75.13|||GEE model||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48||75.13|29.84|< 0.0001
73809875|NCT02537431|147169058|OTHER||LS mean|37.29|||||TWO_SIDED|95.0|13.19|61.38|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72||61.38|13.19|
73809876|NCT02537431|147169058|OTHER||LS mean|29.29|||||TWO_SIDED|95.0|3.18|55.4|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96||55.40|3.18|
73809877|NCT02537431|147169058|OTHER||LS mean|2.14|||||TWO_SIDED|95.0|-17.67|21.94|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII||21.94|-17.67|
73809878|NCT02537431|147169059|OTHER||LS Mean|133.08|||||TWO_SIDED|95.0|106.26|159.89|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12||159.89|106.26|
73809879|NCT02537431|147169059|OTHER||LS Mean|137.8|||||TWO_SIDED|95.0|106.95|168.65|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24||168.65|106.95|
73809880|NCT02537431|147169059|OTHER||LS Mean|76.86|||<|0.0001|TWO_SIDED|95.0|49.2|104.53|||GEE model||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48||104.53|49.20|< 0.0001
73809881|NCT02537431|147169059|OTHER||LS mean|50.46|||||TWO_SIDED|95.0|23.69|77.23|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72||77.23|23.69|
73809882|NCT02537431|147169059|OTHER||LS mean|41.36|||||TWO_SIDED|95.0|18.69|64.03|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96||64.03|18.69|
73809883|NCT02537431|147169059|OTHER||LS mean|26.2|||||TWO_SIDED|95.0|6.76|45.64|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII||45.64|6.76|
73809884|NCT02537431|147169060|OTHER||LS Mean|464.84|||||TWO_SIDED|95.0|343.92|585.77|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12||585.77|343.92|
73809885|NCT02537431|147169060|OTHER||LS Mean|404.13|||||TWO_SIDED|95.0|294.47|513.78|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24||513.78|294.47|
73809886|NCT02537431|147169060|OTHER||LS Mean|175.13|||<|0.0001|TWO_SIDED|95.0|88.85|261.41|||GEE model||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48||261.41|88.85|< 0.0001
73809887|NCT02537431|147169060|OTHER||LS mean|143.11|||||TWO_SIDED|95.0|-38.2|324.41|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72||324.41|-38.20|
73809888|NCT02537431|147169060|OTHER||LS mean|76.8|||||TWO_SIDED|95.0|-35.62|189.22|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96||189.22|-35.62|
73809889|NCT02537431|147169060|OTHER||LS mean|-41.32|||||TWO_SIDED|95.0|-204.28|121.64|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII||121.64|-204.28|
73809890|NCT02537431|147169061|OTHER||LS Mean|89.68|||||TWO_SIDED|95.0|63.58|115.78|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12||115.78|63.58|
73809891|NCT02537431|147169061|OTHER||LS Mean|70.17|||||TWO_SIDED|95.0|49.9|90.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24||90.44|49.90|
73809892|NCT02537431|147169061|OTHER||LS Mean|35.86|||<|0.0001|TWO_SIDED|95.0|21.37|50.36|||GEE model||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48||50.36|21.37|< 0.0001
73809893|NCT02537431|147169061|OTHER||LS mean|34.0|||||TWO_SIDED|95.0|6.53|61.47|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72||61.47|6.53|
73809894|NCT02537431|147169061|OTHER||LS mean|25.86|||||TWO_SIDED|95.0|9.27|42.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96||42.44|9.27|
73809895|NCT02537431|147169061|OTHER||LS mean|17.88|||||TWO_SIDED|95.0|-0.32|36.07|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII||36.07|-0.32|
73809896|NCT02537431|147169062|OTHER||LS Mean|10.93|||||TWO_SIDED|95.0|3.98|17.89|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12||17.89|3.98|
73809897|NCT02537431|147169062|OTHER||LS Mean|5.82|||||TWO_SIDED|95.0|-0.02|11.66|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24||11.66|-0.02|
73809898|NCT02537431|147169062|OTHER||LS Mean|4.5||||0.2592|TWO_SIDED|95.0|-3.32|12.32|||GEE model||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48||12.32|-3.32|0.2592
73809899|NCT02537431|147169062|OTHER||LS mean|3.13|||||TWO_SIDED|95.0|-1.64|7.9|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72||7.90|-1.64|
73809900|NCT02537431|147169062|OTHER||LS mean|1.14|||||TWO_SIDED|95.0|-2.84|5.11|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96||5.11|-2.84|
73809901|NCT02537431|147169062|OTHER||LS mean|-5.8|||||TWO_SIDED|95.0|-12.46|0.85|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII||0.85|-12.46|
73809902|NCT02537431|147169063|OTHER||LS Mean|52.54|||||TWO_SIDED|95.0|21.18|83.9|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12||83.90|21.18|
73809903|NCT02537431|147169063|OTHER||LS Mean|31.37|||||TWO_SIDED|95.0|8.23|54.51|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24||54.51|8.23|
73809904|NCT02537431|147169063|OTHER||l|24.35||||0.1672|TWO_SIDED|95.0|-10.2|58.9|||GEE model||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48||58.90|-10.20|0.1672
73809905|NCT02537431|147169063|OTHER||LS mean|15.13|||||TWO_SIDED|95.0|-11.19|41.46|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72||41.46|-11.19|
73896057|NCT00796445|147325592|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature.|Hazard Ratio (HR)|0.918||||0.5419|TWO_SIDED|95.0|0.698|1.207|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.207|0.698|0.5419
73809906|NCT02537431|147169063|OTHER||LS mean|6.92|||||TWO_SIDED|95.0|-13.44|27.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96||27.28|-13.44|
73809907|NCT02537431|147169063|OTHER||LS mean|-27.3|||||TWO_SIDED|95.0|-52.33|-2.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII||-2.28|-52.33|
73809908|NCT00794040|147169064|SUPERIORITY||Odds Ratio (OR)|11.7||||0.006|TWO_SIDED|95.0|2.0|68.16||priori threshold p\<0.05|Multilevel growth curve model|||||68.16|2.00|0.006
73809909|NCT00794040|147169065|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.085|TWO_SIDED|95.0|-1.32|0.09||priori threshold \<0.05|Multilevel growth curve model|||||0.09|-1.32|0.085
73809910|NCT00794040|147169066|SUPERIORITY||Mean Difference (Final Values)|4.72||||0.124|TWO_SIDED|95.0|-1.3|10.74||priori threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||10.74|-1.30|0.124
73809911|NCT00794040|147169067|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.993|TWO_SIDED|95.0|-4.76|4.8||priori threshold p\<0.05|Multilevel growth curve model|||||4.80|-4.76|0.993
73809912|NCT00794040|147169068|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.598|TWO_SIDED|95.0|-4.23|2.19||priori threshold p\<0.05|Multilevel growth curve model|||||2.19|-4.23|0.598
73809913|NCT03626363|147169069|SUPERIORITY|We sought to have up to 20 participants complete each group so that we could have a statistical power of 0.89 to detect about a 4 burst per minute difference with an alpha of 0.05. We would have had sympathetic nerve data on up to 18 more of the 21 participants that we were not allowed to post-test in the spring of 2020 due to COVID-19 restrictions.|Mean Difference (Net)|-2.0||||0.51|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in the mean number of bursts per minute of muscle sympathetic nerve activity (MSNA) from pre to post.||||0.51
73809914|NCT03626363|147169070|SUPERIORITY|To detect a 0.5 meter per second change in carotid-to-femoral pulse wave velocity with at least 80% power with an alpha of 0.05 we should have had at least 12 participants complete measurements in each group (MBSR and SME). We fell a little short of that in the MBSR group and met the 12 participants in the SME group. The number of participants we were able to study from pre to post was limited by COVID-19 restrictions.|Mean Difference (Net)|-0.2||||0.25|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in carotid-to-femoral pulse wave velocity in meters per second from pre to post. We had 21 participants in the spring of 2020 that were were not allowed to bring into the laboratory for post testing during COVID-19 restrictions which led to our limited sample size.||||0.25
73809915|NCT01871402|147169145|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.||||||<0.001
73809916|NCT01871402|147169146|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance (\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).||||<0.001
73809917|NCT01871402|147169147|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73809918|NCT01871402|147169148|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance (\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevations).|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).||||<0.001
73809919|NCT04594941|147169151|OTHER||Least Sqaure (LS) Mean Difference|-0.149|STANDARD_ERROR_OF_MEAN|0.754||0.8452|TWO_SIDED|90.0|-1.431|1.133|||Mixed-effects model for repeated measure|||"Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.133|-1.431|0.8452
73809920|NCT04594941|147169151|OTHER||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|1.109||0.989|TWO_SIDED|90.0|-1.899|1.868|||Mixed-effects model for repeated measure|||"SPE VS HPLC: Reader 1~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.868|-1.899|0.9890
73809921|NCT04594941|147169151|OTHER||LS Mean Difference|-0.753|STANDARD_ERROR_OF_MEAN|0.854||0.3852|TWO_SIDED|90.0|-2.204|0.698|||Mixed-effects model for repeated measure|||"Reader 2: SPE VS HPLC~Reader 2: Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||0.698|-2.204|0.3852
73809922|NCT04594941|147169151|OTHER||LS Mean Difference|-0.091|STANDARD_ERROR_OF_MEAN|0.968||0.926|TWO_SIDED|90.0|-1.735|1.554|||Mixed-effects model for repeated measure|||"Reader 3: SPE VS HPLC~Analysis was based on MMRM model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.554|-1.735|0.9260
73809923|NCT04594941|147169152|OTHER||LS Mean Difference|-0.219|STANDARD_ERROR_OF_MEAN|1.109||0.8452|TWO_SIDED|90.0|-2.104|1.667|||Mixed-effects model for repeated measure|||"Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.667|-2.104|0.8452
73809924|NCT04594941|147169152|OTHER||Least Square Mean (LSM) Difference|-0.023|STANDARD_ERROR_OF_MEAN|1.63||0.989|TWO_SIDED|90.0|-2.793|2.747|||Mixed-effects model for repeated measure|||"Reader 1: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||2.747|-2.793|0.9890
73809925|NCT04594941|147169152|OTHER||LS Mean Difference|-1.107|STANDARD_ERROR_OF_MEAN|1.256||0.3852|TWO_SIDED|90.0|-3.241|1.027|||Mixed-effects model for repeated measure|||"Reader 2: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.027|-3.241|0.3852
73809926|NCT04594941|147169152|OTHER||LS Mean Difference|-0.133|STANDARD_ERROR_OF_MEAN|1.424||0.926|TWO_SIDED|90.0|-2.552|2.285|||Mixed-effects model for repeated measure|||"Reader 3: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||2.285|-2.552|0.9260
73809927|NCT04594941|147169153|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 1||||<0.0001
73809928|NCT04594941|147169153|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
73809929|NCT04594941|147169153|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
73809930|NCT04594941|147169153|OTHER|||||||0.0072|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0072
73809931|NCT04594941|147169153|OTHER|||||||0.0051|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0051
73809932|NCT04594941|147169153|OTHER|||||||0.0023|||||||Wilcoxon Signed Rank Test|||Reader 3||||0.0023
73809933|NCT04594941|147169153|OTHER|||||||0.0002|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0002
73809934|NCT04594941|147169153|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
73809935|NCT04594941|147169153|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
73809936|NCT04594941|147169154|OTHER|||||||0.0089|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0089
73809937|NCT04594941|147169154|OTHER|||||||0.0207|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0207
73809938|NCT04594941|147169154|OTHER|||||||0.0089|||||||Wilcoxon Signed Rank Test|||Reader 3||||0.0089
73809939|NCT04594941|147169154|OTHER|||||||0.732|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.732
73809940|NCT04594941|147169154|OTHER|||||||0.0083|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0083
73809941|NCT04594941|147169154|OTHER|||||||0.0412|||||||Wilcoxon (Mann-Whitney)|||Reader 3||||0.0412
73809942|NCT04594941|147169154|OTHER|||||||0.0001|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0001
73809943|NCT04594941|147169154|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
73809944|NCT04594941|147169154|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
73809945|NCT04594941|147169156|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||1.0000|1.0000|
73809946|NCT04594941|147169156|OTHER||Kappa Statistics|0.6957|||||TWO_SIDED|95.0|0.1696|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|0.1696|
73809947|NCT04594941|147169156|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|1.0000|
73809948|NCT04594941|147169156|OTHER||Kappa Statistics|0.4615|||||TWO_SIDED|95.0|-0.0699|0.993|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||0.9930|-0.0699|
73809949|NCT04594941|147169156|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|1.0000|
73809950|NCT04594941|147169156|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|1.0000|
73809951|NCT04594941|147169156|OTHER||Kappa Statistics|0.8811|||||TWO_SIDED|95.0|0.6567|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||1.0000|0.6567|
73809952|NCT04594941|147169156|OTHER||Kappa Statistics|0.8828|||||TWO_SIDED|95.0|0.6614|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|0.6614|
73809953|NCT04594941|147169156|OTHER||Kappa Statistics|0.8811|||||TWO_SIDED|95.0|0.6567|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|0.6567|
73809954|NCT02031640|147169199|SUPERIORITY||Least Square Mean (LSM) Difference|0.034||||0.272|TWO_SIDED|95.0|-0.027|0.095|||ANCOVA|||||0.095|-0.027|0.272
73809955|NCT02031640|147169199|SUPERIORITY||LSM Difference|0.045||||0.1415|TWO_SIDED|95.0|-0.015|0.106|||ANCOVA|||||0.106|-0.015|0.1415
73809956|NCT02031640|147169199|SUPERIORITY||LSM Difference|-0.015||||0.6356|TWO_SIDED|95.0|-0.075|0.046|||ANCOVA|||||0.046|-0.075|0.6356
73809957|NCT02031640|147169199|SUPERIORITY||LSM Difference|0.04||||0.1932|TWO_SIDED|95.0|-0.02|0.1|||ANCOVA|||||0.1|-0.02|0.1932
73809958|NCT02031640|147169200|OTHER|The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction.|LSM Difference|10.616||||0.0036|TWO_SIDED|95.0|3.489|17.744|||Mixed Model for repeated measures|||||17.744|3.489|0.0036
73809959|NCT02031640|147169200|SUPERIORITY||LSM Difference|8.419||||0.0204|TWO_SIDED|95.0|1.309|15.53|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||15.53|1.309|0.0204
73809960|NCT02031640|147169200|SUPERIORITY||LSM Difference|6.004||||0.0984|TWO_SIDED|95.0|-1.121|13.129|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||13.129|-1.121|0.0984
73896058|NCT00917644|147325608|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|98.79||||||90.0|94.57|103.2|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||103.20|94.57|
73896059|NCT00917644|147325610|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%). AUCinf method of determination includes AUClast calculated value.|Ratio of adjusted geometric means|98.72||||||90.0|94.41|103.23|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||103.23|94.41|
73896060|NCT00917644|147325611|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|104.66||||||90.0|95.73|114.42|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Observed directly from data.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||114.42|95.73|
73896061|NCT01816945|147325624|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
73896062|NCT01816945|147325627|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Two-sample t-test for PHQ-9 at 12 months||||0.96
73809961|NCT02031640|147169200|SUPERIORITY||LSM Difference|12.512||||0.0006|TWO_SIDED|95.0|5.435|19.589|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||19.589|5.435|0.0006
73809962|NCT02031640|147169201|SUPERIORITY||LSM Difference|9.147||||0.0139|TWO_SIDED|95.0|1.866|16.429|||Mixed Model for repeated measures|||||16.429|1.866|0.0139
73809963|NCT02031640|147169201|SUPERIORITY||LSM Difference|9.17||||0.0133|TWO_SIDED|95.0|1.914|16.425|||Mixed Model for repeated measures|||||16.425|1.914|0.0133
73809964|NCT02031640|147169201|SUPERIORITY||LSM Difference|4.088||||0.2704|TWO_SIDED|95.0|-3.191|11.367|||Mixed Model for repeated measures|||||11.367|-3.191|0.2704
73809965|NCT02031640|147169201|SUPERIORITY||LSM Difference|10.301||||0.0053|TWO_SIDED|95.0|3.073|17.53|||Mixed Model for repeated measures|||||17.53|3.073|0.0053
73809966|NCT02031640|147169202|SUPERIORITY||LSM Difference|-0.703|||<|0.0001|TWO_SIDED|95.0|-1.044|-0.363|||Mixed Model for repeated measures|||||-0.363|-1.044|<0.0001
73809967|NCT02031640|147169202|SUPERIORITY||LSM Difference|-0.691|||<|0.0001|TWO_SIDED|95.0|-1.029|-0.352|||Mixed Model for repeated measures|||||-0.352|-1.029|<0.0001
73809968|NCT02031640|147169202|SUPERIORITY||LSM Difference|-0.651||||0.0002|TWO_SIDED|95.0|-0.994|-0.309|||Mixed Model for repeated measures|||||-0.309|-0.994|0.0002
73809969|NCT02031640|147169202|SUPERIORITY||LSM difference|-0.801|||<|0.0001|TWO_SIDED|95.0|-1.138|-0.464|||Mixed Model for repeated measures|||||-0.464|-1.138|<0.0001
73809970|NCT02031640|147169203|SUPERIORITY||Mean Difference (Final Values)|-0.149||||0.0119|TWO_SIDED|95.0|-0.265|-0.033|||Mixed Models Analysis|||||-0.033|-0.265|0.0119
73809971|NCT02031640|147169203|SUPERIORITY||Mean Difference (Final Values)|-0.102||||0.0854|TWO_SIDED|95.0|-0.217|0.014|||Mixed Models Analysis|||||0.014|-0.217|0.0854
73809972|NCT02031640|147169203|SUPERIORITY||Mean Difference (Final Values)|-0.189||||0.0016|TWO_SIDED|95.0|-0.306|-0.072|||Mixed Models Analysis|||||-0.072|-0.306|0.0016
73809973|NCT02031640|147169203|SUPERIORITY||Mean Difference (Final Values)|-0.216||||0.0003|TWO_SIDED|95.0|-0.332|-0.101|||Mixed Models Analysis|||||-0.101|-0.332|0.0003
73809974|NCT05356533|147169206|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
73809975|NCT05356533|147169206|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
73809976|NCT05356533|147169207|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
73809977|NCT05356533|147169208|SUPERIORITY||Risk Ratio (RR)|0.81|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
73809978|NCT05356533|147169209|SUPERIORITY||Risk Ratio (RR)|0.91|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
73809979|NCT05356533|147169210|SUPERIORITY||Risk Ratio (RR)|0.99|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
73809980|NCT05356533|147169211|SUPERIORITY||Risk Ratio (RR)|1.11|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
73809981|NCT03085238|147169217|NON_INFERIORITY|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.1309|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)||||0.1309
73809982|NCT03085238|147169218|NON_INFERIORITY|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.0181|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)||||.0181
73809983|NCT05896527|147169227|SUPERIORITY||Odds Ratio (OR)|0.46||||0.4839|TWO_SIDED|95.0|0.07|2.37|||Fisher Exact||DC-806 200 mg BID compared to Placebo|||2.37|0.07|0.4839
73809984|NCT05896527|147169227|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4111|TWO_SIDED|95.0|0.51|6.49|||Fisher Exact||DC-806 400 mg BID compared to Placebo|||6.49|0.51|0.4111
73809985|NCT05896527|147169227|SUPERIORITY||Odds Ratio (OR)|1.3||||0.7744|TWO_SIDED|95.0|0.36|4.99|||Fisher Exact||DC-806 600 mg QD compared to Placebo|||4.99|0.36|0.7744
73809986|NCT05896527|147169227|SUPERIORITY||Odds Ratio (OR)|3.59||||0.0164|TWO_SIDED|95.0|1.15|12.37|||Fisher Exact||DC-806 800 mg BID compared to Placebo|||12.37|1.15|0.0164
73809987|NCT01279070|147169229|SUPERIORITY_OR_OTHER||Effect size|0.43|||<|0.05|TWO_SIDED|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML.An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 16 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.||0.7|0.1|<0.05
73809988|NCT01279070|147169230|SUPERIORITY_OR_OTHER||Effect Size|0.42|||<|0.05|TWO_SIDED|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood(REML).An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 40 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.||0.7|0.1|<0.05
73809989|NCT01279070|147169231|SUPERIORITY_OR_OTHER||Effect Size|0.33|||<|0.05|TWO_SIDED|95.0|0.06|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.6|0.06|<0.05
73809990|NCT01279070|147169232|SUPERIORITY_OR_OTHER||Effect Size|0.35|||<|0.05|TWO_SIDED|95.0|0.09|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.6|0.09|<0.05
73809991|NCT01279070|147169233|SUPERIORITY_OR_OTHER||Effect Size|0.3|||<|0.05|TWO_SIDED|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.7|0.01|<0.05
73809992|NCT01279070|147169234|SUPERIORITY_OR_OTHER||Effect Size|0.3|||<|0.05|TWO_SIDED|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups, standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR) assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.7|0.01|<0.05
73809993|NCT05139303|147169240|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73809994|NCT03875482|147169273|SUPERIORITY||Mean Difference|59.0|||<|0.001|TWO_SIDED|95.0|48.4|69.6|||Chi-squared|||The variable was analyzed using the Chi-square test. Both null hypotheses corresponding to the co-primary endpoints must be rejected simultaneously under a two-sided significance level of 0.05.||69.6|48.4|<0.001
73809995|NCT03875482|147169274|SUPERIORITY||Mean Difference|68.5|||<|0.001|TWO_SIDED|95.0|57.2|79.7|||Chi-squared|||The variable was analyzed using the Chi-square test. Both null hypotheses corresponding to the co-primary endpoints must be rejected simultaneously under a two-sided significance level of 0.05.||79.7|57.2|<0.001
73809996|NCT03875482|147169275|SUPERIORITY||Mean Difference|36.2|||<|0.001|TWO_SIDED|95.0|26.2|46.2|||Chi-squared|||The ranked secondary efficacy endpoints at Week 16 were to be tested between the risankizumab and placebo treatment groups among the ITT Population in a hierarchical order only if the null hypotheses for both primary endpoints had been rejected.||46.2|26.2|<0.001
73809997|NCT03875482|147169276|SUPERIORITY||Mean Difference|37.1|||<|0.001|TWO_SIDED|95.0|27.1|47.2|||Chi-squared|||The ranked secondary efficacy endpoints at Week 16 were to be tested between the risankizumab and placebo treatment groups among the ITT Population in a hierarchical order only if the null hypotheses for both primary endpoints and for the first secondary endpoint had been rejected.||47.2|27.1|<0.001
73809998|NCT03875482|147169277|SUPERIORITY||LS Mean Difference|-36.14|STANDARD_ERROR_OF_MEAN|4.956|<|0.001|TWO_SIDED|95.0|-45.936|-26.346|||Mixed-effect Model Repeat Measurements||Risankizumab - placebo|"Risankizumab vs placebo at Week 4~Mixed-effect Model Repeat Measurements (MMRM): The repeated measures analysis was conducted using a mixed model including the baseline value and observed measurements at all post-baseline visits. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction as covariates."||-26.346|-45.936|<0.001
73809999|NCT03875482|147169277|SUPERIORITY||LS Mean Difference|-59.97|STANDARD_ERROR_OF_MEAN|5.326|<|0.001|TWO_SIDED|95.0|-70.501|-49.439|||Mixed-effect Model Repeat Measurements||Risankizumab - placebo|"Risankizumab vs placebo at Week 16~Mixed-effect Model Repeat Measurements (MMRM): The repeated measures analysis was conducted using a mixed model including the baseline value and observed measurements at all post-baseline visits. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction as covariates."||-49.439|-70.501|<0.001
73810000|NCT02045862|147169280|SUPERIORITY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.69|-0.21||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.69|<0.001
73810001|NCT02045862|147169280|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.37|0.11||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.11|-0.37|0.002
73810002|NCT02045862|147169281|SUPERIORITY||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.77|-0.2||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.77|<0.001
73810003|NCT02045862|147169281|SUPERIORITY||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.71|-0.13||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.13|-0.71|0.004
73810004|NCT02045862|147169282|SUPERIORITY||Least Squares Mean Difference|15.84|STANDARD_ERROR_OF_MEAN|3.49|<|0.001|TWO_SIDED|95.0|8.99|22.69|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||22.69|8.99|<0.001
73810005|NCT02045862|147169282|SUPERIORITY||Least Squares Mean Difference|12.77|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|5.98|19.57|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||19.57|5.98|<0.001
73810006|NCT02045862|147169283|SUPERIORITY||Least Squares Mean Difference|-7.55|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-10.05|-5.05|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-5.05|-10.05|<0.001
73810007|NCT02045862|147169283|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-7.09|-2.12|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-2.12|-7.09|<0.001
73810008|NCT02045862|147169284|SUPERIORITY||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.28|0.82|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.82|0.28|<0.001
73810009|NCT02045862|147169284|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.32|0.86|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.86|0.32|<0.001
73810010|NCT02045862|147169286|SUPERIORITY||Rate Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.54|0.84|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.||0.84|0.54|<0.001
73810011|NCT02045862|147169286|SUPERIORITY||Rate Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.12||0.029|TWO_SIDED|95.0|0.61|0.97|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.||0.97|0.61|0.029
73810012|NCT02045862|147169287|SUPERIORITY||Least Squares Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-4.76|-1.49||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.49|-4.76|<0.001
73810013|NCT02045862|147169287|SUPERIORITY||Least Squares Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.84|<|0.001|TWO_SIDED|95.0|-2.57|0.72||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.72|-2.57|<0.001
73810014|NCT02045862|147169288|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.26|2.01|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate||2.01|1.26|<0.001
73810015|NCT02045862|147169288|SUPERIORITY||Odds Ratio (OR)|1.38||||0.009|TWO_SIDED|95.0|1.08|1.75|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate.||1.75|1.08|0.009
73896063|NCT01816945|147325628|SUPERIORITY|||||||0.043|||||||t-test, 2 sided|||Two-sample t-test for Social Network Score at 12 month||||0.043
73810016|NCT02045862|147169289|SUPERIORITY||Odds Ratio (OR)|1.61|||<|0.001|TWO_SIDED|95.0|1.26|2.05|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.||2.05|1.26|<0.001
73810017|NCT02045862|147169289|SUPERIORITY||Odds Ratio (OR)|1.45||||0.002|TWO_SIDED|95.0|1.14|1.85|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.||1.85|1.14|0.002
73810018|NCT02045862|147169290|SUPERIORITY||Least Squares Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.65|-0.21||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.65|<0.001
73810019|NCT02045862|147169290|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.11||0.009|TWO_SIDED|95.0|-0.36|0.09||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate||0.09|-0.36|0.009
73810020|NCT02045862|147169291|SUPERIORITY||Rate Ratio|0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|0.48|0.79|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days at EoT as the offset variable||0.79|0.48|<0.001
73810021|NCT02045862|147169291|SUPERIORITY||Rate Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.13||0.023|TWO_SIDED|95.0|0.58|0.96|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day at EoT as the offset variable||0.96|0.58|0.023
73810022|NCT02045862|147169292|SUPERIORITY||Least Squares Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.51|-1.46||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.46|-4.51|<0.001
73810023|NCT02045862|147169292|SUPERIORITY||Stratified Rank ANCOVA|-0.93|STANDARD_ERROR_OF_MEAN|0.78||0.006|TWO_SIDED|95.0|-2.47|0.61||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.61|-2.47|0.006
73810024|NCT02045862|147169294|SUPERIORITY||Odds Ratio (OR)|1.44||||0.002|TWO_SIDED|95.0|1.14|1.8|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.8|1.14|0.002
73810025|NCT02045862|147169294|SUPERIORITY||Odds Ratio (OR)|1.37||||0.007|TWO_SIDED|95.0|1.09|1.73|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.73|1.09|0.007
73810026|NCT02045862|147169295|SUPERIORITY||Least Squares Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.16|-0.41|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.41|-1.16|<0.001
73810027|NCT02045862|147169295|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.037|TWO_SIDED|95.0|-0.77|-0.02|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.02|-0.77|0.037
73810028|NCT02045862|147169297|SUPERIORITY||Least Squares Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.1|-0.37|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.37|-1.10|<0.001
73810029|NCT02045862|147169297|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.036|TWO_SIDED|95.0|-0.76|-0.03|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.03|-0.76|0.036
73810030|NCT02045862|147169298|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.059|TWO_SIDED|95.0|-0.19|0.0|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.00|-0.19|0.059
73810031|NCT02045862|147169298|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.068|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.19|0.068
73810032|NCT02045862|147169299|SUPERIORITY||Rate Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.06||0.067|TWO_SIDED|95.0|0.81|1.01|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable||1.01|0.81|0.067
73810033|NCT02045862|147169299|SUPERIORITY||Rate Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.06||0.131||95.0|0.82|1.03|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day as the offset variable.||1.03|0.82|0.131
73810034|NCT02045862|147169300|SUPERIORITY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.35||0.055|TWO_SIDED|95.0|-1.34|0.01|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.01|-1.34|0.055
73810035|NCT02045862|147169300|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.048|TWO_SIDED|95.0|-1.39|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.01|-1.39|0.048
73810036|NCT02045862|147169301|SUPERIORITY||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED|95.0|-0.69|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.16|-0.69|0.002
73896064|NCT00422084|147325629|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the PCR-corrected ACPR response rate at Day 28 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction) and a 5% non-inferiority margin. Non-inferiority was demonstrated if the lower limit of the CI for the difference \>-5%.|ACPR percent difference|0.3||||0.578|TWO_SIDED|95.0|-0.7|1.8||If non-inferiority of PA is demonstrated, the p-value associated with a superiority test was calculated based on a 2-sided Chi-square test. If the calculated p-value is \<5%, then the superiority of PA compared to AL is statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (AL) by more than 5%.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (AL) by more than -5%."||1.8|-0.7|0.578
73810037|NCT02045862|147169301|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.039|TWO_SIDED|95.0|-0.55|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.55|0.039
73810038|NCT02045862|147169302|SUPERIORITY||Rate Ratio|0.58|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.45|0.76|||Negative Binomial Regression|||Rate ratio vs. Mirabegron 50 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.||0.76|0.45|<0.001
73810039|NCT02045862|147169302|SUPERIORITY||Rate Ratio|0.76|STANDARD_ERROR_OF_MEAN|0.14||0.044|TWO_SIDED|95.0|0.58|0.99|||Negative Binomial Regression|||Rate ratio vs. Solifenacin 5 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.||0.99|0.58|0.044
73810040|NCT02045862|147169303|SUPERIORITY||Least Squares Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.92||0.001|TWO_SIDED|95.0|-4.78|-1.18|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.18|-4.78|0.001
73810041|NCT02045862|147169303|SUPERIORITY||Least Squares Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.072|TWO_SIDED|95.0|-3.52|0.15|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.15|-3.52|0.072
73810042|NCT02045862|147169305|SUPERIORITY||Least Squares Mean Difference|4.76|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|2.56|6.96|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||6.96|2.56|<0.001
73810043|NCT02045862|147169305|SUPERIORITY||Least Squares Mean Difference|2.86|STANDARD_ERROR_OF_MEAN|1.11||0.01|TWO_SIDED|95.0|0.68|5.04|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.04|0.68|0.010
73810044|NCT02045862|147169306|SUPERIORITY||Least Squares Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|2.99|8.2|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||8.20|2.99|<0.001
73810045|NCT02045862|147169306|SUPERIORITY||Least Squares Mean Difference|3.01|STANDARD_ERROR_OF_MEAN|1.32||0.022|TWO_SIDED|95.0|0.43|5.6|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.60|0.43|0.022
73810046|NCT02045862|147169307|SUPERIORITY||Least Squares Mean Difference|5.01|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|2.65|7.38|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||7.38|2.65|<0.001
73810047|NCT02045862|147169307|SUPERIORITY||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|1.43|6.13|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||6.13|1.43|0.002
73896065|NCT01087736|147325666|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.89||||0.019|TWO_SIDED|95.0|0.89|0.98||We tested our Primary hypothesis with a random-intercept repeated subject negative binomial model, modeling week (baseline - week 12) as a continuous variable. All analyses were intent-to-treat and used all observations from all weeks.|negative binomial regression|||Our primary protocol-defined analysis was to examine the within-group efficacy of topiramate to reduce percent drinking days (%DD).||0.98|0.89|0.019
73896066|NCT01087736|147325666|SUPERIORITY_OR_OTHER|||||||0|||||||Other|||There were no pre hoc hypothesis regarding change within placebo group. We were only tested change within the topiramate condition.||||0.00
73810048|NCT02045862|147169308|SUPERIORITY||Least Squares Mean Difference|5.15|STANDARD_ERROR_OF_MEAN|1.36|<|0.001|TWO_SIDED|95.0|2.47|7.83|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||7.83|2.47|<0.001
73810049|NCT02045862|147169308|SUPERIORITY||Least Squares Mean Difference|3.27|STANDARD_ERROR_OF_MEAN|1.35||0.016|TWO_SIDED|95.0|0.62|5.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.93|0.62|0.016
73810050|NCT02045862|147169309|SUPERIORITY||Least Squares Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|0.98||0.006|TWO_SIDED|95.0|0.77|4.59|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||4.59|0.77|0.006
73810051|NCT02045862|147169309|SUPERIORITY||Least Squares Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.97||0.287|TWO_SIDED|95.0|-0.87|2.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||2.93|-0.87|0.287
73810052|NCT02045862|147169311|SUPERIORITY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.47|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.16|-0.47|<0.001
73810053|NCT02045862|147169311|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.011|TWO_SIDED|95.0|-0.36|-0.05|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.05|-0.36|0.011
73810054|NCT02045862|147169323|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.26|2.15|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||2.15|1.26|<0.001
73810055|NCT02045862|147169323|SUPERIORITY||Odds Ratio (OR)|1.27||||0.08|TWO_SIDED|95.0|0.97|1.67|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.67|0.97|0.080
73896067|NCT01087736|147325666|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.38||||0.036|TWO_SIDED|95.0|0.15|0.94|||Negative binomial model|||"A secondary analysis was powered to detect a Signal or statistical trend (p\<0.10) for a difference between the topiramate and placebo condition. We compared percent drinking days per week between groups averaged over the active phase of the trial (weeks 1-12). The negative binomial model included fixed effect for week, treatment group, and the interaction between treatment group and week. We covaried for baseline %DD averages to control for prestudy and study enrollment effects."||0.94|0.15|0.036
73810056|NCT02045862|147169324|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.001|TWO_SIDED|95.0|1.49|2.78|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.78|1.49|<0.001
73810057|NCT02045862|147169324|SUPERIORITY||Odds Ratio (OR)|1.87|||<|0.001|TWO_SIDED|95.0|1.37|2.57|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.57|1.37|<0.001
73810058|NCT02045862|147169325|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.001|TWO_SIDED|95.0|1.36|2.43|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.43|1.36|<0.001
73810059|NCT02045862|147169325|SUPERIORITY||Odds Ratio (OR)|1.44||||0.014|TWO_SIDED|95.0|1.08|1.92|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||1.92|1.08|0.014
73810060|NCT02045862|147169326|SUPERIORITY||Odds Ratio (OR)|1.8|||<|0.001|TWO_SIDED|95.0|1.34|2.41|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.41|1.34|<0.001
73810061|NCT02045862|147169326|SUPERIORITY||Odds Ratio (OR)|1.44||||0.019|TWO_SIDED|95.0|1.06|1.95|||Regression, Logistic|||Odds ratio wa from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.95|1.06|0.019
73810062|NCT02045862|147169327|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.26|2.19|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.19|1.26|<0.001
73810063|NCT02045862|147169327|SUPERIORITY||Odds Ratio (OR)|1.23||||0.133|TWO_SIDED|95.0|0.94|1.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.62|0.94|0.133
73810064|NCT02045862|147169328|SUPERIORITY||Odds Ratio (OR)|1.55||||0.002|TWO_SIDED|95.0|1.18|2.03|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.03|1.18|0.002
73810065|NCT02045862|147169328|SUPERIORITY||Odds Ratio (OR)|1.48||||0.006|TWO_SIDED|95.0|1.12|1.95|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.95|1.12|0.006
73810066|NCT02045862|147169329|SUPERIORITY||Odds Ratio (OR)|1.68|||<|0.001|TWO_SIDED|95.0|1.24|2.29|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.29|1.24|<0.001
73810067|NCT02045862|147169329|SUPERIORITY||Odds Ratio (OR)|1.29||||0.109|TWO_SIDED|95.0|0.94|1.77|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||1.77|0.94|0.109
73810068|NCT02045862|147169330|SUPERIORITY||Odds Ratio (OR)|1.69|||<|0.001|TWO_SIDED|95.0|1.26|2.25|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.25|1.26|<0.001
73810069|NCT02045862|147169330|SUPERIORITY||Odds Ratio (OR)|1.62|||<|0.001|TWO_SIDED|95.0|1.22|2.16|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.16|1.22|<0.001
73810070|NCT02045862|147169331|SUPERIORITY||Odds Ratio (OR)|1.99|||<|0.001|TWO_SIDED|95.0|1.5|2.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.62|1.50|<0.001
73810071|NCT02045862|147169331|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.35|2.36|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.36|1.35|<0.001
73810072|NCT02045862|147169332|SUPERIORITY||Odds Ratio (OR)|1.93|||<|0.001|TWO_SIDED|95.0|1.46|2.54|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.54|1.46|<0.001
73810073|NCT02045862|147169332|SUPERIORITY||Odds Ratio (OR)|1.59||||0.001|TWO_SIDED|95.0|1.2|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.09|1.20|0.001
73810074|NCT02045862|147169333|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.28|2.26|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.||2.26|1.28|<0.001
73810075|NCT02045862|147169333|SUPERIORITY||Odds Ratio (OR)|1.4||||0.019|TWO_SIDED|95.0|1.06|1.86|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.||1.86|1.06|0.019
73810076|NCT02045862|147169334|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.001|TWO_SIDED|95.0|1.4|2.46|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.46|1.40|<0.001
73810077|NCT02045862|147169334|SUPERIORITY||Odds Ratio (OR)|1.58||||0.001|TWO_SIDED|95.0|1.19|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.09|1.19|0.001
73810078|NCT02045862|147169335|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.33|2.34|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||2.34|1.33|<0.001
73810079|NCT02045862|147169335|SUPERIORITY||Odds Ratio (OR)|1.43||||0.012|TWO_SIDED|95.0|1.08|1.89|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.89|1.08|0.012
73810080|NCT02357706|147169351|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs"|Mean Difference (Final Values)|1.24||||0.537|TWO_SIDED||||||t-test, 1 sided|||"Comparison of AHI/ oxygen desaturation index (ODI) of Device A compared with Device B.~Efficacy is defined as a residual AHI and ODI on each night of the trial. PSG scored AHI and ODI will be collected on both trial nights (excluding the ramp period); and compared using the Paired T test"||||0.537
73810081|NCT02357706|147169351|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|1.24||||0.05|TWO_SIDED||||||t-test, 1 sided|||||||0.05
73810082|NCT02357706|147169352|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.205|TWO_SIDED||||||t-test, 1 sided|||||||0.205
73810083|NCT02357706|147169352|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.134|TWO_SIDED||||||t-test, 1 sided|||||||0.134
73810084|NCT02822573|147169409|SUPERIORITY|Mixed effects repeated measures analysis of covariance (RMANCOVA) models with covariates of treatment, time, time by treatment interaction, baseline outcome level, age stratification and an unstructured covariance matrix. The primary objective was assessed using a linear contrast of group effect at 24 weeks.||||||0.32|||||||ANCOVA|||With a sample size of 266, there was 90% power to detect a treatment difference of 2 words for HVLT-R total recall score (SD=4.26, effect size=0.47) with a two-sided 5% level of significance. This calculation assumed an ANCOVA model analysis with 25% dropout and 2% missing data at end of treatment. A single interim analysis for futility occurred after 138 participants, with stopping rule of two-sided p-value \< 0.0154. This design required 3.5% more than fixed design, increasing total to 276.||||0.32
73810085|NCT01044290|147169416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|||<|0.61|TWO_SIDED|95.0|-1.1|0.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||.7|-1.1|<0.61
73810086|NCT01044290|147169416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||<|0.02|TWO_SIDED|95.0|0.2|2.0|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.||2.0|.2|<.02
73810087|NCT01044290|147169417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|||=|0.9|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||1.1|-1.2|=.9
73810088|NCT01044290|147169417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||<|0.97|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks.||1.1|-1.2|<.97
73810089|NCT01044290|147169418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|||<|0.91|TWO_SIDED|95.0|-1.4|1.5|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks||1.5|-1.4|<.91
73810090|NCT01044290|147169418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||=|0.42|TWO_SIDED|95.0|-2.1|0.9|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks||0.9|-2.1|=.42
73896068|NCT01087736|147325667|SUPERIORITY_OR_OTHER||||||<|0.026|||||||Mixed Models Analysis|||We planned to explore the efficacy of topiramate in reducing PTSD symptom severity. We used random-intercept linear mixed models to explore the efficacy for topiramate related reduction in PTSD symptomatology. We looked for an effect of week within TOP. Baseline scores for PTSD symptoms were used as covariates in group comparisons. All analyses were intent-to-treat and used all observations from all weeks.||||<0.026
73810091|NCT01044290|147169419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|||=|0.58|TWO_SIDED|95.0|-1.5|2.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||2.8|-1.5|=.58
73896069|NCT01087736|147325667|SUPERIORITY_OR_OTHER|||||||0|||||||Other|||There was not a pre hoc hypothesis regarding change within placebo group. We only examined within group change in the topiramate condition.||||0.00
73810092|NCT01044290|147169419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|||<|0.97|TWO_SIDED|95.0|-2.1|2.2|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.||2.2|-2.1|<.97
73810093|NCT01044290|147169420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.25|TWO_SIDED|95.0|-0.6|2.4|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||2.4|-.6|.25
73810094|NCT01044290|147169420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.05|TWO_SIDED|95.0|0.05|3.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||3.1|.05|<.05
73810095|NCT01044290|147169421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||<|0.57|TWO_SIDED|95.0|-1.0|1.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.||1.8|-1.0|<.57
73896070|NCT00759564|147325679|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|124.71|||||TWO_SIDED|90.0|106.57|145.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||145.94|106.57|
73810096|NCT01044290|147169421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|||=|0.055|TWO_SIDED|95.0|-0.03|2.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.||2.7|-0.03|=0.055
73810097|NCT01646021|147169430|OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.35|0.6|||Log Rank|||||0.60|0.35|< 0.0001
73810098|NCT01646021|147169432|SUPERIORITY||Hazard Ratio (HR)|0.74|||=|0.0621|TWO_SIDED|95.0|0.54|1.02|||Log Rank|||||1.02|0.54|= 0.0621
73810099|NCT01663779|147169447|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.01|TWO_SIDED|95.0|3.0|7.0|||Chi-squared|||||7|3|<0.01
73810100|NCT01967706|147169453|OTHER||Geometric LS Mean Ratio|88.47|||||TWO_SIDED|95.0|68.64|114.03|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||114.03|68.64|
73810101|NCT01967706|147169454|OTHER||Geometric LS Mean Ratio|98.13|||||TWO_SIDED|95.0|80.61|119.46|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||119.46|80.61|
73810102|NCT02347891|147169461|SUPERIORITY||Risk Ratio (RR)|0.5||||0.6|TWO_SIDED|95.0|0.08|2.65|||ANOVA|||Definition of Improvement (DOI) at week 40||2.65|0.08|0.60
73810103|NCT02347891|147169461|SUPERIORITY||Risk Ratio (RR)|0.6||||0.61|TWO_SIDED|95.0|0.16|1.82|||ANOVA|||Percent patients reaching Total improvement score of ≥40 at Week 40||1.82|0.16|0.61
73896071|NCT00759564|147325679|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|163.51|||||TWO_SIDED|90.0|139.72|191.34||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||191.34|139.72|
73810104|NCT02347891|147169461|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Percent of patient with major improvement TIS ≥60 at Week 40||1.47|0|0.23
73896072|NCT00759564|147325679|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|58.4|||||TWO_SIDED|90.0|48.16|70.83||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||70.83|48.16|
73896073|NCT00759564|147325681|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|167.59|||||TWO_SIDED|90.0|137.27|204.61||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||204.61|137.27|
73810105|NCT02347891|147169462|SUPERIORITY|||||||0.92|||||||ANOVA|||Mean Total Improvement Score (TIS) during Randomized Phase at Week 40||||0.92
73810106|NCT02347891|147169463|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Definition of Improvement (DOI) at Week 64||1.47|0|0.23
73810107|NCT02347891|147169463|SUPERIORITY||Risk Ratio (RR)|0.75||||0.99|TWO_SIDED|95.0|0.19|2.51|||ANOVA|||Percent patients reaching Total improvement score of ≥40 at Week 64||2.51|0.19|0.99
73810108|NCT02347891|147169463|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Percent of patient with major improvement TIS ≥60 at Week 64||1.47|0|0.23
73810109|NCT02347891|147169464|SUPERIORITY|||||||0.62|||||||ANOVA|||Mean Total Improvement Score (TIS) after Open Label Phase at 64 Week||||0.62
73810110|NCT05010512|147169482|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with terms for lens, period and sequence as fixed effects, subject as a random effect. Difference = DT1 minus Infuse|||0.01||
73810111|NCT01152359|147169517|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.05|TWO_SIDED|95.0|-0.8|2.9|||Mixed Models Analysis|||||2.9|-0.8|<0.05
73810112|NCT01152359|147169518|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.66|TWO_SIDED|95.0|-4.9|3.1|||Mixed Models Analysis|||||3.1|-4.9|0.66
73810113|NCT01152359|147169519|SUPERIORITY||Mean Difference (Net)|-0.8||||0.65|TWO_SIDED|95.0|-4.1|2.6|||Mixed Models Analysis|||||2.6|-4.1|0.65
73810114|NCT03197870|147169562|SUPERIORITY|The primary hypotheses was tested in the modified intent-to-treat population using a Fisher's Exact Test with a 2-sided 5% significance level. razuprotafib 15 mg twice daily was tested first. If this was found to be statistically significant, then razuprotafib 15 mg once daily will be tested for statistical significance, at the same significance level.||||||0.495||||||Missing data was imputed using last observation carried forward; baseline values were not carried forward.|Fisher Exact|||The primary hypotheses tested was that razuprotafib 15 mg twice daily and razuprotafib 15 mg once daily will be superior to placebo in the improvement of diabetic retinopathy as measured by the Early Treatment Diabetic Retinopathy Study severity scale change from baseline at 48 weeks.||||0.495
73810115|NCT01323010|147169572|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Chi-squared|||||||0.689
73810116|NCT01323010|147169573|SUPERIORITY_OR_OTHER|||||||0.591|TWO_SIDED||||||t-test, 2 sided|||||||0.591
73810117|NCT01323010|147169574|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||ANOVA|Method: ANOVA with repetead measures for non parametric data proposed by Brunner and Piri.||||||0.150
73810118|NCT01323010|147169575|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
73810119|NCT01323010|147169576|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||ANOVA|||||||0.108
73810120|NCT01323010|147169578|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||ANOVA|||||||0.122
73810121|NCT01323010|147169580|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||ANOVA|Method: ANOVA with repetead measures for non paramteric data proposed by Brunner and Piri.||||||0.164
73810122|NCT01323010|147169581|SUPERIORITY_OR_OTHER|||||||0.165|TWO_SIDED||||||ANOVA|||||||0.165
73810123|NCT01323010|147169582|SUPERIORITY_OR_OTHER|||||||0.436|TWO_SIDED||||||ANOVA|||||||0.436
73810124|NCT01323010|147169583|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED||||||ANOVA|||||||0.046
73810125|NCT01323010|147169584|SUPERIORITY_OR_OTHER|||||||0.723|TWO_SIDED||||||ANOVA|||||||0.723
73810126|NCT01323010|147169585|SUPERIORITY_OR_OTHER|||||||0.235|TWO_SIDED||||||ANOVA|||||||0.235
73810127|NCT01323010|147169586|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED||||||ANOVA|||||||0.284
73810128|NCT01323010|147169587|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED||||||ANOVA|||||||0.905
73810129|NCT01323010|147169590|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.892
73810130|NCT01323010|147169591|SUPERIORITY_OR_OTHER|||||||0.195|TWO_SIDED||||||Chi-squared|||||||0.195
73810131|NCT01323010|147169592|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED||||||Chi-squared, Corrected|||||||0.203
73810132|NCT01323010|147169593|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Chi-squared|||||||0.03
73896074|NCT00759564|147325681|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|246.76|||||TWO_SIDED|90.0|202.11|301.27||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||301.27|202.11|
73810133|NCT02951533|147169614|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73810134|NCT05174949|147169658|SUPERIORITY|We performed a linear regression analysis (generalized estimating equations) in which we compared both intervention groups to the sham group and added a time interaction term|Mean Difference (Final Values)|5.4|STANDARD_DEVIATION|3.58|<|0.0001|TWO_SIDED|95.0|2.4|8.4||Anode compared to sham: p = 0.0516 Cathode compared to sham: p \<.0001 . Anode change over time compared to sham p=0.0255 Cathode change over time compared to sham p\<.0001|Generalized Estimating Equations||Anode mean change = 4.13 std = 4.29 CLM = 0.5-7.7 Cathode mean change = 5.38 std = 3.58 CLM=2.4-8.4|We will report first anode compared to sham and then cathode compared to sham||8.4|2.4|<0.0001
73810135|NCT05174949|147169659|SUPERIORITY||Mean Difference (Final Values)|-24.2|STANDARD_DEVIATION|9.5||0.002|TWO_SIDED|95.0|-32.2|-16.2||anode compared to sham p= 0.0020 cathode compared to sham p = 0.0088 anode over time anode compared to sham p \<.0001 Cathode over time compared to sham p \<.0001|Regression, Cox||anode -24.2 (-32.2, -16.2) cathode -22.2 (-30.6, -13.8)|We compared anode to sham We compared cathode to sham We compared the change over time of anode to sham We compared the change over time of cathode to shal||-16.2|-32.2|0.0020
73896075|NCT00759564|147325681|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|107.13|||||TWO_SIDED|90.0|88.06|130.32||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||130.32|88.06|
73810136|NCT05174949|147169660|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.0001|TWO_SIDED|95.0|0.0|0.1||Compare anode to sham p= 0.0001 Compare cathode to sham p=0.1073 Compare anode change in time to sham p=0.0938 Compare cathode change in time to sham 0.0068|Regression, Linear|Using generalized estimating equations with group and time component|Anode = 0.077 (0.00, 0.10) Cathode = -.0.125 (-0.32 0.07 )|e compare anode to sham We compare cathode to sham||0.10|0.00|0.0001
73810137|NCT03724877|147169673|OTHER||Adjusted hazard ratio (HR)|1.04|||||TWO_SIDED|95.0|0.79|1.38|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted forced expiratory volume1 (FEV1).|||1.38|0.79|
73810138|NCT03724877|147169674|OTHER||Adjusted HR|0.97|||||TWO_SIDED|95.0|0.87|1.09|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|||1.09|0.87|
73810139|NCT03724877|147169675|OTHER||Adjusted HR|1.46|||||TWO_SIDED|95.0|1.03|2.07|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|||2.07|1.03|
73810140|NCT03724877|147169676|OTHER||Adjusted rate ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04|||Negative binomial regression model||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Moderate/ sever exacerbation||1.04|0.83|
73810141|NCT03724877|147169676|OTHER||Adjusted rate ratio|0.94|||||TWO_SIDED|95.0|0.7|1.28|||Negative binomial regression model||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Severe exacerbation||1.28|0.70|
73810142|NCT00742508|147169681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.38|STANDARD_ERROR_OF_MEAN|5.449|||TWO_SIDED|95.0|-5.75|24.51|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||24.51|-5.75|
73810143|NCT00742508|147169681|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.55|STANDARD_ERROR_OF_MEAN|5.849|||TWO_SIDED|95.0|-8.68|23.79|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||23.79|-8.68|
73810144|NCT00742508|147169681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.92|STANDARD_ERROR_OF_MEAN|3.645|||TWO_SIDED|95.0|-12.04|8.2|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||8.20|-12.04|
73810145|NCT00742508|147169681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.21|STANDARD_ERROR_OF_MEAN|6.361|||TWO_SIDED|95.0|-3.45|31.87|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||31.87|-3.45|
73810146|NCT00742508|147169681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|3.79|||TWO_SIDED|95.0|-10.12|10.92|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||10.92|-10.12|
73810147|NCT00742508|147169681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.04|STANDARD_ERROR_OF_MEAN|4.281|||TWO_SIDED|95.0|13.16|36.93|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||36.93|13.16|
73810148|NCT00742508|147169681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|10.62||||95.0|-29.94|29.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||29.03|-29.94|
73810149|NCT00742508|147169681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.31|STANDARD_ERROR_OF_MEAN|7.194|||TWO_SIDED|95.0|-11.67|28.28|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||28.28|-11.67|
73810150|NCT00742508|147169681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|-0.63|0.15|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.15|-0.63|
73810151|NCT00742508|147169701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|4.833|||TWO_SIDED|95.0|-11.2|15.63|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||15.63|-11.20|
73810152|NCT00742508|147169701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|6.265|||TWO_SIDED|95.0|-17.95|16.84|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||16.84|-17.95|
73810153|NCT00742508|147169701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.93|STANDARD_ERROR_OF_MEAN|3.885|||TWO_SIDED|95.0|-15.71|5.86|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||5.86|-15.71|
73810154|NCT00742508|147169701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|95.0|-7.11|26.59|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||26.59|-7.11|
73810155|NCT00742508|147169701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.45|STANDARD_ERROR_OF_MEAN|4.08|||TWO_SIDED|95.0|-14.78|7.88|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||7.88|-14.78|
73810156|NCT00742508|147169701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.06|STANDARD_ERROR_OF_MEAN|1.694|||TWO_SIDED|95.0|13.36|22.76|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||22.76|13.36|
73810157|NCT00742508|147169701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.46|STANDARD_ERROR_OF_MEAN|8.902|||TWO_SIDED|95.0|-32.17|17.26|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||17.26|-32.17|
73896076|NCT00759564|147325682|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|168.14|||||TWO_SIDED|90.0|137.4|205.75||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||205.75|137.40|
73810158|NCT00742508|147169701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|5.297|||TWO_SIDED|95.0|-13.61|15.8|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||15.80|-13.61|
73810159|NCT00742508|147169701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|95.0|-0.54|0.3|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.30|-0.54|
73810160|NCT00742508|147169702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.99|STANDARD_ERROR_OF_MEAN|3.187|||TWO_SIDED|95.0|-12.84|4.86|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||4.86|-12.84|
73810161|NCT00742508|147169702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.27|STANDARD_ERROR_OF_MEAN|2.962|||TWO_SIDED|95.0|-13.5|2.95|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||2.95|-13.50|
73810162|NCT00742508|147169702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.98|STANDARD_ERROR_OF_MEAN|3.209|||TWO_SIDED|95.0|-10.89|6.94|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||6.94|-10.89|
73810163|NCT00742508|147169702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.14|STANDARD_ERROR_OF_MEAN|3.665|||TWO_SIDED|95.0|-14.32|6.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||6.03|-14.32|
73810164|NCT00742508|147169702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.99|STANDARD_ERROR_OF_MEAN|3.047|||TWO_SIDED|95.0|-11.45|5.47|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||5.47|-11.45|
73810165|NCT00742508|147169702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.11|STANDARD_ERROR_OF_MEAN|4.686|||TWO_SIDED|95.0|-16.12|9.89|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||9.89|-16.12|
73810166|NCT00742508|147169702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.0|STANDARD_ERROR_OF_MEAN|3.749|||TWO_SIDED|95.0|-20.41|0.41|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||0.41|-20.41|
73810167|NCT00742508|147169702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.42|STANDARD_ERROR_OF_MEAN|5.249|||TWO_SIDED|95.0|-16.0|13.15|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||13.15|-16.00|
73810168|NCT00742508|147169702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.71|0.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.03|-0.71|
73810169|NCT02715700|147169709|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||TWO_SIDED|90.0|0.9|1.01||||||||1.01|0.90|
73810170|NCT02715700|147169710|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||TWO_SIDED|90.0|0.88|1.03||||||||1.03|0.88|
73810171|NCT02715700|147169711|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||||1.03|0.93|
73810172|NCT02715700|147169713|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.9|1.06||||||||1.06|0.90|
73810173|NCT02715700|147169714|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||TWO_SIDED|90.0|0.86|1.1||||||||1.10|0.86|
73810174|NCT02715700|147169715|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||||1.04|0.91|
73810175|NCT02715700|147169717|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||TWO_SIDED|90.0|0.9|1.03||||||||1.03|0.90|
73810176|NCT02715700|147169718|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||TWO_SIDED|90.0|0.87|1.05||||||||1.05|0.87|
73810177|NCT02715700|147169719|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.92|1.03||||||||1.03|0.92|
73810178|NCT02730377|147169721|SUPERIORITY||||||<|0.0001|||||||Log Rank|||Test for no treatment difference is based on using a generalised log-rank test for interval censored failure time data.||||<.0001
73810179|NCT03796442|147169757|NON_INFERIORITY|The study was designed to have 80% power to detect 1-year AVMPG of 12.6±4.3mmHg for the study prosthesis and 11.9±4.3mmHg for the control prosthesis, with a 1-sided type I error of 2.5% and a noninferiority margin of 3mmHg. The noninferiority margin was determined by the values of 15mmHg for AVMPG of clinically significant aortic stenosis and 12mmHg for AVMPG of the control prosthesis.||||||0.0004|||||||t-test, 1 sided|||The null hypothesis was that the AvalusTM was inferior to the CEPME based on the AVMPG at 1-year echocardiographic follow-up, with a non-inferiority margin of 3mmHg. The result for the primary endpoint was presented with 97.5% one-sided confidence interval for mean difference between groups. The non-inferiority test was performed using a t-test which compared mean difference between groups with the non-inferiority margin under the one-sided significance level of 0.025.||||0.0004
73810180|NCT00401544|147169773|SUPERIORITY_OR_OTHER||Percentage of participants|71.0||||||95.0|63.0|80.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||80|63|
73810181|NCT00401544|147169773|SUPERIORITY_OR_OTHER||Percentage of participants|63.0||||||95.0|54.0|72.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||72|54|
73810182|NCT00401544|147169774|SUPERIORITY_OR_OTHER||Percentage of participants|73.0||||||95.0|64.0|81.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||81|64|
73810183|NCT00401544|147169774|SUPERIORITY_OR_OTHER||Percentage of participants|62.0||||||95.0|54.0|71.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||71|54|
73810184|NCT00401544|147169779|SUPERIORITY_OR_OTHER||Percentage of participants|36.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||44|27|
73810185|NCT00401544|147169779|SUPERIORITY_OR_OTHER||Percentage of participants|38.0||||||95.0|29.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||47|29|
73810186|NCT00401544|147169780|SUPERIORITY_OR_OTHER||Percentage of participants|35.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||44|27|
73810187|NCT00401544|147169780|SUPERIORITY_OR_OTHER||Percentage of participants|39.0||||||95.0|30.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||47|30|
73810188|NCT00401544|147169781|SUPERIORITY_OR_OTHER||Percentage of participants|26.0||||||95.0|15.0|38.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||38|15|
73810189|NCT00401544|147169781|SUPERIORITY_OR_OTHER||Percentage of participants|31.0||||||95.0|19.0|42.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||42|19|
73810190|NCT00401544|147169781|SUPERIORITY_OR_OTHER||Percentage of participants|28.0||||||95.0|17.0|40.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||40|17|
73810191|NCT00401544|147169781|SUPERIORITY_OR_OTHER||Percentage of participants|25.0||||||95.0|14.0|36.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||36|14|
73810192|NCT00401544|147169782|SUPERIORITY_OR_OTHER||Percentage of participants|68.0||||||95.0|59.0|76.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||76|59|
73810193|NCT00401544|147169782|SUPERIORITY_OR_OTHER||Percentage of participants|59.0||||||95.0|50.0|68.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||68|50|
73810194|NCT00401544|147169783|SUPERIORITY_OR_OTHER||Percentage of participants|53.0||||||95.0|44.0|62.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||62|44|
73810195|NCT00401544|147169783|SUPERIORITY_OR_OTHER||Percentage of participants|74.0||||||95.0|66.0|82.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||82|66|
73810196|NCT02729038|147169814|OTHER||Ratio of geometric LS means|1.507|||||TWO_SIDED|90.0|0.902|2.519|||||AUC (0-inf) for participants with normal renal function Vs participants with moderate renal function has been presented.|||2.519|0.902|
73810197|NCT02729038|147169814|OTHER||Ratio of geometric LS means|1.924|||||TWO_SIDED|90.0|1.151|3.215|||||AUC (0-inf) for participants with normal renal function Vs participants with Severe/ESRD not on hemodialysis|||3.215|1.151|
73810198|NCT02729038|147169815|OTHER||Ratio of geometric LS means|2.375|||||TWO_SIDED|90.0|1.421|3.969|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)|||3.969|1.421|
73810199|NCT02729038|147169815|OTHER||Ratio of geometric LS means|4.075|||||TWO_SIDED|90.0|2.438|6.81|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)|||6.810|2.438|
73810200|NCT02729038|147169816|OTHER||Ratio of geometric LS means|1.179|||||TWO_SIDED|90.0|0.467|2.977|||||Cmax for participants with normal renal function Vs participants with moderate renal function has been presented.|||2.977|0.467|
73810201|NCT02729038|147169816|OTHER||Ratio of geometric LS means|1.575|||||TWO_SIDED|90.0|0.624|3.975|||||Cmax for participants with normal renal function Vs .participants with Severe/ESRD not on hemodialysis|||3.975|0.624|
73810202|NCT02729038|147169817|OTHER||Ratio of geometric LS means|2.25|||||TWO_SIDED|90.0|0.891|5.681|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)|||5.681|0.891|
73810203|NCT02729038|147169817|OTHER||Ratio of geometric LS means|5.966|||||TWO_SIDED|90.0|2.363|15.062|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)|||15.062|2.363|
73810204|NCT02729038|147169839|OTHER||Ratio of geometric LS means|1.501|||||TWO_SIDED|90.0|0.894|2.52|||||Normal Vs Moderate|||2.520|0.894|
73810205|NCT02729038|147169839|OTHER||Ratio of geometric LS means|1.912|||||TWO_SIDED|90.0|1.139|3.212|||||Normal Vs Severe/ESRD not on hemodialysis|||3.212|1.139|
73810206|NCT02729038|147169840|OTHER||Ratio of geometric LS means|2.375|||||TWO_SIDED|90.0|1.414|3.989|||||Normal Vs ESRD on hemodialysis (before hemodialysis)|||3.989|1.414|
73810207|NCT02729038|147169840|OTHER||Ratio of geometric LS means|4.068|||||TWO_SIDED|90.0|2.422|6.831|||||Normal Vs ESRD on hemodialysis (after hemodialysis)|||6.831|2.422|
73810208|NCT02275780|147169864|NON_INFERIORITY|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|3.913|||||TWO_SIDED|95.0|-1.59|9.415|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||9.415|-1.590|
73810209|NCT02275780|147169865|NON_INFERIORITY|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|7.082|||||TWO_SIDED|95.0|0.508|13.656|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||13.656|0.508|
73810210|NCT02275780|147169866|OTHER||Mean treatment difference|7.1|||||TWO_SIDED|95.0|-20.8|35.0|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||35.0|-20.8|
73810211|NCT02275780|147169867|OTHER||Mean treatment difference|17.4|||||TWO_SIDED|95.0|-14.5|49.3|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||49.3|-14.5|
73810212|NCT02275780|147169868|OTHER||Treatment Difference (mg/dL)|-14.61|||<|0.0001|TWO_SIDED|95.0|-18.15|-11.06|||ANCOVA|Terms for Baseline lipid level and treatment group||||-11.06|-18.15|<0.0001
73810213|NCT02275780|147169869|OTHER||Treatment Difference (mg/dL)|-19.34|||<|0.0001|TWO_SIDED|95.0|-23.33|-15.35|||ANCOVA|Terms for Baseline lipid level and treatment group||||-15.35|-23.33|<0.0001
73810214|NCT02275780|147169878|OTHER||Treatment Difference|4.169|||||TWO_SIDED|95.0|-1.404|9.743|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||9.743|-1.404|
73810215|NCT02275780|147169879|OTHER||Treatment Difference|7.606|||||TWO_SIDED|95.0|0.98|14.232|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||14.232|0.980|
73810216|NCT03960866|147169880|SUPERIORITY||Mean Difference (Net)|0.12||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
73810217|NCT05845567|147169964|SUPERIORITY||ratio of the Geometric LSmeans|139.43|||||TWO_SIDED|90.0|129.73|149.86||||||||149.86|129.73|
73896077|NCT00759564|147325682|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|248.38|||||TWO_SIDED|90.0|202.98|303.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||303.94|202.98|
73896078|NCT00759564|147325682|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|110.12|||||TWO_SIDED|90.0|89.84|134.98||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||134.98|89.84|
73896079|NCT00759564|147325684|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|134.86|||||TWO_SIDED|90.0|109.88|165.52||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||165.52|109.88|
73896080|NCT00759564|147325684|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|226.28|||||TWO_SIDED|90.0|184.36|277.72||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||277.72|184.36|
73810218|NCT05845567|147169965|SUPERIORITY||ratio of the Geometric LSmeans|117.97|||||TWO_SIDED|90.0|112.24|124.0||||||||124.00|112.24|
73810219|NCT05845567|147169966|SUPERIORITY||ratio of the Geometric LSmeans|117.88|||||TWO_SIDED|90.0|112.13|123.92||||||||123.92|112.13|
73810220|NCT03409107|147169975|SUPERIORITY||LS Mean Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.23|1.56|||ANCOVA|One-sided p-value based on test of null hypothesis: (Daprodustat - Placebo) \<= 0 versus alternative: difference \> 0.|Treatment group comparisons were based on a ANCOVA model with terms for treatment, Baseline hemoglobin, and region.|||1.56|1.23|<0.0001
73810221|NCT03409107|147169976|SUPERIORITY||Difference in Response rate|0.56|||<|0.0001|TWO_SIDED|95.0|0.49|0.63||One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \<=0 versus alternative: difference \> 0|Cochran-Mantel-Haenszel||Treatment group comparisons were based on a Cochran-Mantel-Haenszel test adjusted for treatment group and region.|||0.63|0.49|<0.0001
73810222|NCT03409107|147169977|SUPERIORITY||LS Mean Difference|5.36||||0.0005|TWO_SIDED|95.0|2.17|8.56||One-sided p-value based on test of null hypothesis:(Daprodustat-Placebo) \<= 0 vs alternative: difference \> 0.|ANCOVA||Treatment group comparisons were based on ANCOVA model with terms for treatment, Baseline score, and region.|||8.56|2.17|0.0005
73810223|NCT03409107|147169978|SUPERIORITY||Difference in Response rate|0.45|||<|0.0001|TWO_SIDED|95.0|0.37|0.52||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|Cochran-Mantel-Haenszel||Treatment group comparisons are based on a Cochran-Mantel-Haenszel test adjusted for treatment group, and region|||0.52|0.37|<0.0001
73810224|NCT03409107|147169979|SUPERIORITY||Difference in treatment effect|38.8|||||TWO_SIDED|95.0|25.0|54.55|||Hodges-Lehmann Estimate|Hodges-Lehmann Estimate of treatment difference has been reported.||||54.55|25.00|
73810225|NCT03409107|147169980|SUPERIORITY||Difference in treatment effect|0.768|||<|0.0001|TWO_SIDED|95.0|0.729|0.806||One-sided superiority p-value from the van Elteren test|van Elteren test||Mann-Whitney estimate of the treatment difference stratified by region has been presented.|||0.806|0.729|<0.0001
73810226|NCT03409107|147169981|SUPERIORITY||LS Mean difference|1.36|||<|0.0001|TWO_SIDED|95.0|1.16|1.55||One-sided superiority p-value from the MMRM model|MMRM||Treatment group comparisons were based on MMRM fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline Hb and Baseline Hb by time and treatment by time interactions.|||1.55|1.16|<0.0001
73810227|NCT03409107|147169982|SUPERIORITY||Hazard Ratio (HR)|0.07||||0.0002|TWO_SIDED|95.0|0.02|0.3||One-sided p-value was based on Wald test of null hypothesis: (Daprodustat/Placebo) \>=1 versus alternative: ratio\<1.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group and region.|||0.30|0.02|0.0002
73810228|NCT03409107|147169983|SUPERIORITY||Mean Difference (Net)|5.91|||<|0.0001|TWO_SIDED|95.0|2.83|9.0||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Tired/Low Energy/Weak domain.|||9.00|2.83|<0.0001
73810229|NCT03409107|147169983|SUPERIORITY||Mean Difference (Net)|2.93||||0.0152|TWO_SIDED|95.0|0.28|5.57||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Chest Pain/Shortness of Breath Domain.|||5.57|0.28|0.0152
73810230|NCT03409107|147169983|SUPERIORITY||Mean Difference (Net)|3.79||||0.0045|TWO_SIDED|95.0|0.95|6.63||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Cognitive Domain.|||6.63|0.95|0.0045
73810231|NCT03409107|147169983|SUPERIORITY||Mean Difference (Net)|2.61||||0.1267|TWO_SIDED|95.0|-1.87|7.09||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Difficulty Sleeping|||7.09|-1.87|0.1267
73810232|NCT03409107|147169983|SUPERIORITY||Mean Difference (Net)|4.64||||0.0203|TWO_SIDED|95.0|0.2|9.09||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Difficulty Standing for Long Periods of Time|||9.09|0.20|0.0203
73810233|NCT03409107|147169983|SUPERIORITY||Mean Difference (Net)|2.68||||0.0266|TWO_SIDED|95.0|-0.04|5.39||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Severity of Shortness of Breath While Sitting or Resting|||5.39|-0.04|0.0266
73810234|NCT03409107|147169983|SUPERIORITY||Mean Difference (Net)|2.01||||0.0907|TWO_SIDED|95.0|-0.94|4.96||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Time with Shortness of Breath While not Doing an Activity|||4.96|-0.94|0.0907
73810235|NCT03409107|147169984|SUPERIORITY||Mean Difference (Net)|-0.13||||0.0391|TWO_SIDED|95.0|-0.28|0.02||One-sided p-value was based on test of null hypothesis: (Daprodustat-rhEPO) \>=0 versus alternative: difference \<0|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.02|-0.28|0.0391
73810236|NCT03409107|147169985|SUPERIORITY||Mean Difference (Net)|2.57||||0.0858|TWO_SIDED|95.0|-1.12|6.26||One sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 vs. alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||6.26|-1.12|0.0858
73810237|NCT03409107|147169986|SUPERIORITY||Mean Difference (Net)|0.17||||0.0357|TWO_SIDED|95.0|-0.02|0.36||One sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel full of life?.|||0.36|-0.02|0.0357
73810238|NCT03409107|147169986|SUPERIORITY||Mean Difference (Net)|0.17||||0.0328|TWO_SIDED|95.0|-0.01|0.35||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you have a lot of energy?.|||0.35|-0.01|0.0328
73896081|NCT00759564|147325684|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|285.05|||||TWO_SIDED|90.0|221.8|366.33||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||366.33|221.80|
73810239|NCT03409107|147169986|SUPERIORITY||Mean Difference (Net)|0.18||||0.0252|TWO_SIDED|95.0|0.0|0.37||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel worn out?.|||0.37|0.00|0.0252
73810240|NCT03409107|147169986|SUPERIORITY||Mean Difference (Net)|0.26||||0.001|TWO_SIDED|95.0|0.1|0.42||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel tired?.|||0.42|0.10|0.0010
73810241|NCT03409107|147169993|SUPERIORITY||Mean Difference (Net)|0.03||||0.1098|TWO_SIDED|95.0|-0.02|0.07||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus. alternative: difference \>0.|MMRM||Based on MMRM model fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.07|-0.02|0.1098
73810242|NCT03409107|147169994|SUPERIORITY||Mean Difference (Net)|4.5||||0.012|TWO_SIDED|95.0|0.6|8.4||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 vs. alternative: difference \>0.|MMRM||MMRM model fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||8.40|0.60|0.0120
73810243|NCT03409107|147169995|SUPERIORITY||Mean Difference (Net)|0.4||||0.6106|TWO_SIDED|95.0|-2.42|3.22||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \<0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline SBP and Baseline SBP by time and treatment by time interactions.|||3.22|-2.42|0.6106
73810244|NCT03409107|147169995|SUPERIORITY||Mean Difference (Net)|1.8||||0.9819|TWO_SIDED|95.0|0.12|3.49||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \< 0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline DBP and Baseline DBP by time and treatment by time interactions.|||3.49|0.12|0.9819
73810245|NCT03409107|147169995|SUPERIORITY||Mean Difference (Net)|1.31||||0.9215|TWO_SIDED|95.0|-0.51|3.13||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \<0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline MAP and Baseline MAP by time and treatment by time interactions.|||3.13|-0.51|0.9215
73810246|NCT03409107|147169996|SUPERIORITY||Difference in Response rate|0.06||||0.068|TWO_SIDED|95.0|-0.02|0.13||One-sided p-value based on test of null hypothesis: (Daprodustat - Placebo) \<= 0 versus alternative: difference \> 0.|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test was performed for treatment group comparison.|||0.13|-0.02|0.0680
73810247|NCT00535847|147170004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.703|||||TWO_SIDED|95.0|4.259|37.884||||||Stratified Analysis (Mantel-Haenszel)- The Mantel-Haenszel estimator provides an estimate of the common odds ratio for the association between eRVR and SVR across the prior response strata.||37.884|4.259|
73810248|NCT00715728|147170023|EQUIVALENCE|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.||||||0.91||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|"Two 1-tailed tests were conducted to assess equivalence. See  Type of Statistical Test."||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.||||0.91
73810249|NCT00715728|147170023|EQUIVALENCE|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.|||||<|0.001||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.||||<0.001
73810250|NCT00715728|147170024|NON_INFERIORITY|The non-inferiority margin is defined as 0.5 °C. Non-inferiority at the 0.025 significance level will be claimed if the lower limit of the 95% confidence interval is higher than the -0.5 °C.|Mean Difference (Final Values)|-0.12||||0.018|TWO_SIDED|95.0|-0.37|0.14||P-value was adjusted for preoperative oral temperature and ASA physical status.|t-test, 1 sided||Non-inferiority will be established, at the 0.025 significance level, if the lower limit of a 95% confidence interval for the difference is above -0.5 °C.|Null hypothesis is the Hot dog resistive heating system is inferior to the Bair Hugger forced air system. Mean difference (95% CI) of the intraoperative TWA temperature between the groups (resistive heating versus forced-air) will be adjusting for preoperative oral temperature and ASA physical status.||0.14|-0.37|0.018
73810251|NCT01258075|147170025|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.21||0.5494|TWO_SIDED|95.0|-0.54|0.29|||ANCOVA|Based on a mixed effect ANCOVA model with treatment and previous type 2 diabetes treatment stratum as fixed effects and baseline as a covariate.||||0.29|-0.54|0.5494
73810252|NCT01542034|147170045|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.702|||<|0.001|TWO_SIDED|95.0|2.808|4.88|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||4.880|2.808|<0.001
73810253|NCT01542034|147170046|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.||The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||||<0.001
73810254|NCT01542034|147170047|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|8.541|||<|0.001|TWO_SIDED|95.0|3.62|20.148|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||20.148|3.620|<0.001
73810255|NCT01542034|147170048|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||||<0.001
73810256|NCT02612610|147170049|OTHER||LS Mean Difference|-0.25||||0.0971|TWO_SIDED|95.0|-0.54|0.05|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% confidence intervals (CIs) were estimated using a mixed effect repeated measures (MMRM) model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||0.05|-0.54|0.0971
73810257|NCT02612610|147170049|OTHER||LS Mean Difference|-0.25||||0.0928|TWO_SIDED|95.0|-0.54|0.04|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||0.04|-0.54|0.0928
73810258|NCT02612610|147170049|OTHER||LS Mean Difference|-0.46||||0.0027|TWO_SIDED|95.0|-0.76|-0.16|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||-0.16|-0.76|0.0027
73810259|NCT02612610|147170050|OTHER||LS Mean Difference|-0.19||||0.1914|TWO_SIDED|95.0|-0.47|0.09|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.09|-0.47|0.1914
73810260|NCT02612610|147170050|OTHER||LS Mean Difference|-0.05||||0.7099|TWO_SIDED|95.0|-0.33|0.23|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.23|-0.33|0.7099
73810261|NCT02612610|147170050|OTHER||LS Mean Difference|-0.52||||0.0003|TWO_SIDED|95.0|-0.8|-0.24|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.24|-0.80|0.0003
73810262|NCT02612610|147170051|OTHER||LS Mean Difference|-0.4||||0.0099|TWO_SIDED|95.0|-0.71|-0.1|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.10|-0.71|0.0099
73810263|NCT02612610|147170051|OTHER||LS Mean Difference|-0.28||||0.0695|TWO_SIDED|95.0|-0.58|0.02|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.02|-0.58|0.0695
73810264|NCT02612610|147170051|OTHER||LS Mean Difference|-0.62||||0.0001|TWO_SIDED|95.0|-0.93|-0.31|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.31|-0.93|0.0001
73810265|NCT02612610|147170052|OTHER||LS Mean Difference|-0.24||||0.0991|TWO_SIDED|95.0|-0.52|0.04|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.04|-0.52|0.0991
73810266|NCT02612610|147170052|OTHER||LS Mean Difference|-0.25||||0.0811|TWO_SIDED|95.0|-0.53|0.03|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.03|-0.53|0.0811
73810267|NCT02612610|147170052|OTHER||LS Mean Difference|-0.47||||0.0014|TWO_SIDED|95.0|-0.76|-0.19|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.19|-0.76|0.0014
73810268|NCT02612610|147170053|OTHER||LS Mean Difference|-0.21||||0.1468|TWO_SIDED|95.0|-0.5|0.07|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate. ."||0.07|-0.50|0.1468
73810269|NCT02612610|147170053|OTHER||LS Mean Difference|-0.08||||0.5874|TWO_SIDED|95.0|-0.36|0.2|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.20|-0.36|0.5874
73810270|NCT02612610|147170053|OTHER||LS Mean Difference|-0.49||||0.0008|TWO_SIDED|95.0|-0.78|-0.21|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.21|-0.78|0.0008
73810271|NCT02612610|147170054|OTHER||Mixed Effect Repeated Measures model|-0.39||||0.0177|TWO_SIDED|95.0|-0.7|-0.07|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.07|-0.70|0.0177
73810272|NCT02612610|147170054|OTHER||LS Mean Difference|-0.32||||0.0498|TWO_SIDED|95.0|-0.63|0.0|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.00|-0.63|0.0498
73810273|NCT02612610|147170054|OTHER||LS Mean Difference|-0.59||||0.0004|TWO_SIDED|95.0|-0.92|-0.27|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.27|-0.92|0.0004
73810274|NCT02612610|147170056|OTHER||LS Mean Difference|-6.4||||0.1318|TWO_SIDED|95.0|-14.8|1.9|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.9|-14.8|0.1318
73810275|NCT02612610|147170056|OTHER||LS Mean Difference|-2.9||||0.4917|TWO_SIDED|95.0|-11.3|5.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||5.4|-11.3|0.4917
73810276|NCT02612610|147170056|OTHER||LS Mean Difference|-9.8||||0.0228|TWO_SIDED|95.0|-18.2|-1.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-1.4|-18.2|0.0228
73810277|NCT02612610|147170057|OTHER||LS Mean Difference|-2.6||||0.554|TWO_SIDED|95.0|-11.5|6.2|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||6.2|-11.5|0.5540
73810278|NCT02612610|147170057|OTHER||LS Mean Difference|-3.2||||0.4702|TWO_SIDED|95.0|-12.0|5.6|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||5.6|-12.0|0.4702
73810279|NCT02612610|147170057|OTHER||LS Mean Difference|-10.7||||0.0197|TWO_SIDED|95.0|-19.8|-1.7|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-1.7|-19.8|0.0197
73810280|NCT02612610|147170058|OTHER||LS Mean Difference|-4.4||||0.302|TWO_SIDED|95.0|-12.9|4.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||4.0|-12.9|0.3020
73810281|NCT02612610|147170058|OTHER||LS Mean Difference|-6.4||||0.1365|TWO_SIDED|95.0|-14.8|2.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.0|-14.8|0.1365
73810282|NCT02612610|147170058|OTHER||LS Mean Difference|-11.2||||0.0108|TWO_SIDED|95.0|-19.7|-2.6|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-2.6|-19.7|0.0108
73810283|NCT02612610|147170059|OTHER||LS Mean Difference|-4.0||||0.3509|TWO_SIDED|95.0|-12.3|4.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||4.4|-12.3|0.3509
73810284|NCT02612610|147170059|OTHER||LS Mean Difference|-8.2||||0.0519|TWO_SIDED|95.0|-16.6|0.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-16.6|0.0519
73810285|NCT02612610|147170059|OTHER||LS Mean Difference|-15.9||||0.0003|TWO_SIDED|95.0|-24.3|-7.5|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-7.5|-24.3|0.0003
73810286|NCT02612610|147170060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1387|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1387
73810287|NCT02612610|147170060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7238|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.7238
73810288|NCT02612610|147170060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0144|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0144
73810289|NCT02612610|147170060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0922|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0922
73896082|NCT00759564|147325686|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|209.31|||||TWO_SIDED|90.0|158.81|275.87||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||275.87|158.81|
73896083|NCT00759564|147325686|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|353.0|||||TWO_SIDED|90.0|267.83|465.25||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||465.25|267.83|
73896084|NCT00759564|147325686|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|742.68|||||TWO_SIDED|90.0|529.59|1041.5||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||1041.50|529.59|
73896085|NCT00759564|147325687|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|209.55|||||TWO_SIDED|90.0|158.72|276.66||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||276.66|158.72|
73896086|NCT00759564|147325687|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|353.26|||||TWO_SIDED|90.0|267.57|466.39||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||466.39|267.57|
73896087|NCT00759564|147325687|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|735.77|||||TWO_SIDED|90.0|523.56|1034.0||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||1034.00|523.56|
73896088|NCT02788279|147325705|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9871|TWO_SIDED|95.0|0.73|1.38|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.38|0.73|0.9871
73896089|NCT02788279|147325705|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.336|TWO_SIDED|95.0|0.83|1.71|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.71|0.83|0.3360
73810290|NCT02612610|147170060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3812|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3812
73896090|NCT02788279|147325705|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9686|TWO_SIDED|95.0|0.74|1.38|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.38|0.74|0.9686
73896091|NCT02788279|147325705|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3553|TWO_SIDED|95.0|0.83|1.69|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.69|0.83|0.3553
73896092|NCT02788279|147325706|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.1208|TWO_SIDED|95.0|0.94|1.65|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.65|0.94|0.1208
73810291|NCT02612610|147170060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0088|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0088
73810292|NCT02612610|147170060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0653|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0653
73810293|NCT02612610|147170060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6443|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6443
73810294|NCT02612610|147170060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1511|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1511
73810295|NCT02612610|147170061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0045
73810296|NCT02612610|147170061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0947|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0947
73810297|NCT02612610|147170061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0080
73810298|NCT02612610|147170061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0283
73810299|NCT02612610|147170061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1493|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1493
73810300|NCT02612610|147170061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0026
73810301|NCT02612610|147170061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0652|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0652
73896093|NCT02788279|147325706|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.0509|TWO_SIDED|95.0|1.0|1.94|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.94|1.00|0.0509
73896094|NCT02788279|147325706|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.1726|TWO_SIDED|95.0|0.92|1.6|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.60|0.92|0.1726
73896095|NCT02788279|147325706|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.0467|TWO_SIDED|95.0|1.0|1.91|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.91|1.00|0.0467
73896096|NCT02788279|147325707|SUPERIORITY||Difference in Response Rates|0.51||||1|TWO_SIDED|95.0|-3.92|4.94|||Stratified Cochrane-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.|||4.94|-3.92|1.0000
73810302|NCT02612610|147170061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3601|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3601
73810303|NCT02612610|147170061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0086|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0086
73810304|NCT02612610|147170062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3893|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3893
73810305|NCT02612610|147170062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2803|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2803
73810306|NCT02612610|147170062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0427|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0427
73810307|NCT02612610|147170062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0209|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0209
73810308|NCT02612610|147170062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3401|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3401
73810309|NCT02612610|147170062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0031
73810310|NCT02612610|147170062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0283
73810311|NCT02612610|147170062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6233|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6233
73810312|NCT02612610|147170062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
73810313|NCT02612610|147170063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4925|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4925
73810314|NCT02612610|147170063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9007|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9007
73810315|NCT02612610|147170063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1602
73810316|NCT02612610|147170063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3440
73810317|NCT02612610|147170063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9876|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9876
73810318|NCT02612610|147170063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0993
73810319|NCT02612610|147170063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5968|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5968
73810320|NCT02612610|147170063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8726|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.8726
73810321|NCT02612610|147170063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4092|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4092
73896097|NCT02788279|147325707|SUPERIORITY||Difference in Response Rates|0.0||||1|TWO_SIDED|95.0|-4.89|4.89|||Stratified Cochran-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.|||4.89|-4.89|1.0000
73896098|NCT00329849|147325715|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup A, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|38.0|||||TWO_SIDED|95.0|29.0|47.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup A one month after vaccination of MenACWY-CRM and MenACWY-PS||47|29|
73896099|NCT00329849|147325715|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup C, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|30.0|||||TWO_SIDED|95.0|19.0|40.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup C one month after vaccination of MenACWY-CRM and MenACWY-PS||40|19|
73810322|NCT02612610|147170064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0781|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0781
73810323|NCT02612610|147170064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7098|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.7098
73810324|NCT02612610|147170064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0068|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0068
73810325|NCT02612610|147170064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1284|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1284
73810326|NCT02612610|147170064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.267|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2670
73810327|NCT02612610|147170064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0013
73810328|NCT02612610|147170064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4343|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4343
73810329|NCT02612610|147170064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5384|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5384
73810330|NCT02612610|147170064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0822|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0822
73810331|NCT02612610|147170065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0006
73810332|NCT02612610|147170065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0223|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0223
73810333|NCT02612610|147170065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
73896100|NCT00329849|147325715|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup W, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|28.0|||||TWO_SIDED|95.0|17.0|39.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup W one month after vaccination of MenACWY-CRM and MenACWY-PS||39|17|
73896101|NCT00329849|147325715|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup Y, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|18.0|||||TWO_SIDED|95.0|8.0|28.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup Y one month after vaccination of MenACWY-CRM and MenACWY-PS||28|8|
73810334|NCT02612610|147170065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0165
73810335|NCT02612610|147170065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6255|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6255
73810336|NCT02612610|147170065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0085
73810337|NCT02612610|147170065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0722|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0722
73896102|NCT00329849|147325716|NON_INFERIORITY_OR_EQUIVALENCE|Safety of MenACWY-CRM vaccination was considered non-inferior to the safety of MenACWY-PS vaccination if the upper limit of the two-sided 95% CI of the ratio (MenACWY-CRM group divided by MenACWY-PS group) of the percentage of subjects experiencing at least one severe systemic reaction during 1 to 7 days after vaccination was less than 3.|Group Ratio|6.37|||||TWO_SIDED|95.0|0.82|49.2|||Risk ratio(MenACWY-CRM/MenACWY-PS)|||||49.2|0.82|
73896103|NCT00653432|147325722|SUPERIORITY|||||||0.145|||||||Ordinal GEE Model|||||||0.1450
73810338|NCT02612610|147170065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3577|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3577
73810339|NCT02612610|147170065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0006
73810340|NCT02612610|147170066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3845|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3845
73810341|NCT02612610|147170066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1177|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1177
73810342|NCT02612610|147170066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0236|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0236
73810343|NCT02612610|147170066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0192|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0192
73810344|NCT02612610|147170066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3301|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3301
73810345|NCT02612610|147170066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0008
73810346|NCT02612610|147170066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0285|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0285
73810347|NCT02612610|147170066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3856|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3856
73896104|NCT00653432|147325723|SUPERIORITY|||||||0.5824|||||||Ordinal GEE Model|||||||0.5824
73810348|NCT02612610|147170066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
73810349|NCT02612610|147170067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2441|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2441
73810350|NCT02612610|147170067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5055|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5055
73896105|NCT00653432|147325724|SUPERIORITY|||||||0.9136|||||||Ordinal GEE Model|||||||0.9136
73896106|NCT00653432|147325725|SUPERIORITY|||||||0.1699|||||||Ordinal GEE Model|||||||0.1699
73896107|NCT00653432|147325726|SUPERIORITY|||||||0.3238|||||||Ordinal GEE Model|||||||0.3238
73896108|NCT00653432|147325727|SUPERIORITY|||||||0.0427|||||||Ordinal GEE Model|||||||0.0427
73810351|NCT02612610|147170067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1602
73810352|NCT02612610|147170067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2721|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2721
73810353|NCT02612610|147170067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9763|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9763
73810354|NCT02612610|147170067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0993
73810355|NCT02612610|147170067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4575|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4575
73810356|NCT02612610|147170067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9706|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9706
73810357|NCT02612610|147170067|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3258|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3258
73810358|NCT02612610|147170068|OTHER||LS Mean Difference|0.0||||0.9858|TWO_SIDED|95.0|-0.53|0.54|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.54|-0.53|0.9858
73810359|NCT02612610|147170068|OTHER||LS Mean Difference|-0.01||||0.9813|TWO_SIDED|95.0|-0.53|0.52|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.52|-0.53|0.9813
73810360|NCT02612610|147170068|OTHER||LS Mean Difference|-0.11||||0.6746|TWO_SIDED|95.0|-0.65|0.42|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.42|-0.65|0.6746
73810361|NCT02612610|147170069|OTHER||LS Mean Difference|-0.32||||0.2583|TWO_SIDED|95.0|-0.88|0.24|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.24|-0.88|0.2583
73810362|NCT02612610|147170069|OTHER||LS Mean Difference|0.01||||0.9826|TWO_SIDED|95.0|-0.55|0.56|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.56|-0.55|0.9826
73810363|NCT02612610|147170069|OTHER||LS Mean Difference|-0.4||||0.1672|TWO_SIDED|95.0|-0.98|0.17|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.17|-0.98|0.1672
73810364|NCT02612610|147170070|OTHER||LS Mean Difference|0.14||||0.6102|TWO_SIDED|95.0|-0.4|0.68|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.68|-0.4|0.6102
73896109|NCT00653432|147325728|SUPERIORITY|||||||0.8206|||||||Ordinal GEE Model|||||||0.8206
73896110|NCT00653432|147325729|SUPERIORITY|||||||0.9818|||||||Ordinal GEE Model|||||||0.9818
73896111|NCT00653432|147325730|SUPERIORITY|||||||0.0542|||||||Ordinal GEE Model|||||||0.0542
73896112|NCT00653432|147325731|SUPERIORITY|||||||0.323|||||||Ordinal GEE Model|||||||0.3230
73810365|NCT02612610|147170070|OTHER||LS Mean Difference|0.08||||0.7782|TWO_SIDED|95.0|-0.46|0.61|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.61|-0.46|0.7782
73810366|NCT02612610|147170070|OTHER||LS Mean Difference|0.28||||0.3167|TWO_SIDED|95.0|-0.27|0.83|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.83|-0.27|0.3167
73810367|NCT02612610|147170071|OTHER||LS Mean Difference|0.3||||0.1545|TWO_SIDED|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.7|-0.1|0.1545
73810368|NCT02612610|147170071|OTHER||LS Mean Difference|0.3||||0.2013|TWO_SIDED|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.7|-0.1|0.2013
73810369|NCT02612610|147170071|OTHER||LS Mean Difference|0.0||||0.9962|TWO_SIDED|95.0|-0.4|0.4|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.4|0.9962
73810370|NCT02612610|147170072|OTHER||LS Mean Difference|0.1||||0.7328|TWO_SIDED|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.4|0.7328
73810371|NCT02612610|147170072|OTHER||LS Mean Difference|0.1||||0.7635|TWO_SIDED|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.4|0.7635
73810372|NCT02612610|147170072|OTHER||LS Mean Difference|-0.4||||0.0951|TWO_SIDED|95.0|-0.9|0.1|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-0.9|0.0951
73810373|NCT02612610|147170073|OTHER||LS Mean Difference|-0.2||||0.5797|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5797
73810374|NCT02612610|147170073|OTHER||LS Mean Difference|-0.3||||0.2499|TWO_SIDED|95.0|-0.9|0.2|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-0.9|0.2499
73810375|NCT02612610|147170073|OTHER||LS Mean Difference|-0.5||||0.0612|TWO_SIDED|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.1|0.0612
73810376|NCT02612610|147170074|OTHER||LS Mean Difference|-0.2||||0.5358|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5358
73896113|NCT01782469|147325733|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
73810377|NCT02612610|147170074|OTHER||LS Mean Difference|-0.3||||0.3129|TWO_SIDED|95.0|-0.8|0.3|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.8|0.3129
73896114|NCT01782469|147325733|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
73896115|NCT01782469|147325733|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||<0.001
73896116|NCT01782469|147325733|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
73896117|NCT01782469|147325734|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||Mean number of joints with erosions at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||.130
73896118|NCT01782469|147325734|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||Mean number of joints with erosions at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.031
73810378|NCT02612610|147170074|OTHER||LS Mean Difference|-0.5||||0.1046|TWO_SIDED|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.0|0.1046
73810379|NCT02612610|147170075|OTHER||LS Mean Difference|-0.2||||0.5796|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5796
73810380|NCT02612610|147170075|OTHER||LS Mean Difference|-0.4||||0.143|TWO_SIDED|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.0|0.1430
73810381|NCT02612610|147170075|OTHER||LS Mean Difference|-0.7||||0.0221|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.2|0.0221
73810382|NCT02612610|147170076|OTHER||LS Mean Difference|-0.4||||0.1562|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1562
73810383|NCT02612610|147170076|OTHER||LS Mean Difference|-0.5||||0.071|TWO_SIDED|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.1|0.0710
73896119|NCT01782469|147325734|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||Mean number of joints with erosions at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.006
73896120|NCT01782469|147325734|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Mean number of joints with erosions at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.003
73810384|NCT02612610|147170076|OTHER||LS Mean Difference|-0.7||||0.0274|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.2|0.0274
73810385|NCT02612610|147170077|OTHER||LS Mean Difference|-0.2||||0.4464|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4464
73810386|NCT02612610|147170077|OTHER||LS Mean Difference|-0.3||||0.332|TWO_SIDED|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.9|0.3320
73810387|NCT02612610|147170077|OTHER||LS Mean Difference|-0.5||||0.0792|TWO_SIDED|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.1|0.0792
73810388|NCT02612610|147170078|OTHER||LS Mean Difference|-0.2||||0.4716|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4716
73810389|NCT02612610|147170078|OTHER||LS Mean Difference|-0.2||||0.4371|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4371
73810390|NCT02612610|147170078|OTHER||LS Mean Difference|-0.4||||0.1907|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1907
73810391|NCT02612610|147170079|OTHER||LS Mean Difference|-0.3||||0.2772|TWO_SIDED|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.9|0.2772
73896121|NCT00835211|147325750|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|97.5||||||90.0|87.8|108.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.3|87.8|
73810392|NCT02612610|147170079|OTHER||LS Mean Difference|-0.5||||0.1132|TWO_SIDED|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.1|0.1132
73810393|NCT02612610|147170079|OTHER||LS Mean Difference|-0.6||||0.0737|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.0737
73810394|NCT02612610|147170080|OTHER||LS Mean Difference|-0.1||||0.6266|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6266
73810395|NCT02612610|147170080|OTHER||LS Mean Difference|-0.4||||0.1769|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1769
73810396|NCT02612610|147170080|OTHER||LS Mean Difference|-0.7||||0.0313|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.3|0.0313
73810397|NCT02612610|147170081|OTHER||LS Mean Difference|-0.4||||0.2058|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.2058
73810398|NCT02612610|147170081|OTHER||LS Mean Difference|-0.6||||0.0665|TWO_SIDED|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.2|0.0665
73896122|NCT00835211|147325751|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|95.6||||||90.0|86.9|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.2|86.9|
73896123|NCT00835211|147325752|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|96.5||||||90.0|87.7|106.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.1|87.7|
73810399|NCT02612610|147170081|OTHER||LS Mean Difference|-0.8||||0.0155|TWO_SIDED|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.4|0.0155
73810400|NCT02612610|147170082|OTHER||LS Mean Difference|-0.4||||0.2458|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.2458
73810401|NCT02612610|147170082|OTHER||LS Mean Difference|-0.6||||0.0662|TWO_SIDED|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.2|0.0662
73810402|NCT02612610|147170082|OTHER||LS Mean Difference|-0.7||||0.0197|TWO_SIDED|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.4|0.0197
73810403|NCT02612610|147170083|OTHER||LS Mean Difference|0.3||||0.1921|TWO_SIDED|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.2|0.1921
73810404|NCT02612610|147170083|OTHER||LS Mean Difference|0.3||||0.2428|TWO_SIDED|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.2|0.2428
73810405|NCT02612610|147170083|OTHER||LS Mean Difference|-0.1||||0.7383|TWO_SIDED|95.0|-0.6|0.4|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.6|0.7383
73810406|NCT02612610|147170084|OTHER||LS Mean Difference|0.3||||0.4033|TWO_SIDED|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.9|-0.4|0.4033
73810407|NCT02612610|147170084|OTHER||LS Mean Difference|0.2||||0.4599|TWO_SIDED|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.9|-0.4|0.4599
73810408|NCT02612610|147170084|OTHER||LS Mean Difference|-0.3||||0.2837|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.2837
73810409|NCT02612610|147170085|OTHER||LS Mean Difference|0.1||||0.8084|TWO_SIDED|95.0|-0.6|0.8|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.6|0.8084
73810410|NCT02612610|147170085|OTHER||LS Mean Difference|-0.2||||0.6108|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6108
73810411|NCT02612610|147170085|OTHER||LS Mean Difference|-0.3||||0.422|TWO_SIDED|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.9|0.4220
73810412|NCT02612610|147170086|OTHER||LS Mean Difference|-0.1||||0.8457|TWO_SIDED|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.7|0.8457
73810413|NCT02612610|147170086|OTHER||LS Mean Difference|-0.3||||0.4044|TWO_SIDED|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.9|0.4044
73810414|NCT02612610|147170086|OTHER||LS Mean Difference|-0.3||||0.3031|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.3031
73810415|NCT02612610|147170087|OTHER||LS Mean Difference|0.0||||0.9126|TWO_SIDED|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.7|0.9126
73810416|NCT02612610|147170087|OTHER||LS Mean Difference|-0.5||||0.1136|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.1136
73810417|NCT02612610|147170087|OTHER||LS Mean Difference|-0.7||||0.0352|TWO_SIDED|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.0|-1.4|0.0352
73810418|NCT02612610|147170088|OTHER||LS Mean Difference|-0.5||||0.1718|TWO_SIDED|95.0|-1.1|0.2|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.1|0.1718
73810419|NCT02612610|147170088|OTHER||LS Mean Difference|-0.6||||0.0651|TWO_SIDED|95.0|-1.3|0.0|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.3|0.0651
73810420|NCT02612610|147170088|OTHER||LS Mean Difference|-0.6||||0.0848|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.0848
73810421|NCT02612610|147170089|OTHER||LS Mean Difference|-0.1||||0.6715|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6715
73810422|NCT02612610|147170089|OTHER||LS Mean Difference|-0.3||||0.3514|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.3514
73810423|NCT02612610|147170089|OTHER||LS Mean Difference|-0.4||||0.2809|TWO_SIDED|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.1|0.2809
73810424|NCT02612610|147170090|OTHER||LS Mean Difference|-0.2||||0.6022|TWO_SIDED|95.0|-0.9|0.5|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.9|0.6022
73810425|NCT02612610|147170090|OTHER||LS Mean Difference|-0.3||||0.4456|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4456
73810426|NCT02612610|147170090|OTHER||LS Mean Difference|-0.3||||0.4629|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4629
73810427|NCT02612610|147170091|OTHER||LS Mean Difference|-0.3||||0.3749|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.3749
73810428|NCT02612610|147170091|OTHER||LS Mean Difference|-0.6||||0.0854|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0854
73810429|NCT02612610|147170091|OTHER||LS Mean Difference|-0.4||||0.2672|TWO_SIDED|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.1|0.2672
73810430|NCT02612610|147170092|OTHER||LS Mean Difference|-0.1||||0.7255|TWO_SIDED|95.0|-0.8|0.6|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.8|0.7255
73810431|NCT02612610|147170092|OTHER||LS Mean Difference|-0.6||||0.0918|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0918
73810432|NCT02612610|147170092|OTHER||LS Mean Difference|-0.5||||0.1263|TWO_SIDED|95.0|-1.2|0.2|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.2|0.1263
73810433|NCT02612610|147170093|OTHER||LS Mean Difference|-0.3||||0.4058|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4058
73810434|NCT02612610|147170093|OTHER||LS Mean Difference|-0.6||||0.0828|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0828
73810435|NCT02612610|147170093|OTHER||LS Mean Difference|-0.7||||0.0575|TWO_SIDED|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.4|0.0575
73810436|NCT02612610|147170094|OTHER||LS Mean Difference|-0.3||||0.4163|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4163
73810437|NCT02612610|147170094|OTHER||LS Mean Difference|-0.6||||0.0882|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0882
73810438|NCT02612610|147170094|OTHER||LS Mean Difference|-0.6||||0.0961|TWO_SIDED|95.0|-1.4|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.4|0.0961
73810439|NCT02612610|147170095|OTHER||LS Mean Difference|0.8||||0.163|TWO_SIDED|95.0|-0.3|1.9|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.9|-0.3|0.1630
73896124|NCT02343549|147325753|SUPERIORITY||12-Month Survival Rate|0.333||||0.537|TWO_SIDED|95.0|0.075|0.701||This p-value is only based on partial enrollment of Stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|Assuming the true 12-month survival rate is 0.30 under the null hypothesis, then this design will provide 90% power to detect a difference of 0.20 under the alternative hypothesis, assuming a one-sided alpha = 0.10 significance level. A Simon optimal 2-stage design with Stage 1 n=22 and a total of n=46 subjects was determined with the following rejection regions: For n = 22, the rejection region in number of subjects alive at 12 months is 0 - 7, and for n = 46 it is 8 - 17.||0.701|0.075|0.537
73896125|NCT02343549|147325754|OTHER|Estimation Only|Median|9.9|||||TWO_SIDED|95.0|4.8|12.8|||||The Kaplan Meier method was used to estimate median OS(in months). The Greenwood method was used to estimate confidence limits of median overall survival.|||12.8|4.8|
73896126|NCT02343549|147325755|OTHER|Estimation Only|Median|7.9|||||TWO_SIDED|95.0|4.8|10.4|||||The Kaplan Meier method was used to estimate median PFS (in months). The Greenwood method was used to estimate confidence limits of median progression free survival.|||10.4|4.8|
73810440|NCT02612610|147170095|OTHER||LS Mean Difference|0.2||||0.7601|TWO_SIDED|95.0|-1.0|1.3|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.3|-1.0|0.7601
73810441|NCT02612610|147170095|OTHER||LS Mean Difference|2.1||||0.0004|TWO_SIDED|95.0|0.9|3.2|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||3.2|0.9|0.0004
73810442|NCT02612610|147170096|OTHER||LS Mean Difference|1.0||||0.0941|TWO_SIDED|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.3|-0.2|0.0941
73810443|NCT02612610|147170096|OTHER||LS Mean Difference|0.9||||0.1321|TWO_SIDED|95.0|-0.3|2.2|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.2|-0.3|0.1321
73810444|NCT02612610|147170096|OTHER||LS Mean Difference|1.5||||0.0192|TWO_SIDED|95.0|0.2|2.7|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.7|0.2|0.0192
73810445|NCT02612610|147170097|OTHER||LS Mean Difference|1.2||||0.0626|TWO_SIDED|95.0|-0.1|2.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.4|-0.1|0.0626
73810446|NCT02612610|147170097|OTHER||LS Mean Difference|1.0||||0.0967|TWO_SIDED|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 20 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.3|-0.2|0.0967
73810447|NCT02612610|147170097|OTHER||LS Mean Difference|1.9||||0.0028|TWO_SIDED|95.0|0.7|3.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||3.1|0.7|0.0028
73810448|NCT02612610|147170098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3182|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.3182
73810449|NCT02612610|147170098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5021|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.5021
73810450|NCT02612610|147170098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0665|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0665
73810451|NCT02612610|147170099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0872|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0872
73810452|NCT02612610|147170099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0994|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0994
73896127|NCT02343549|147325756|OTHER|Estimation only|Response Rate|0.333|||||TWO_SIDED|95.0|0.075|0.701|||||Confidence interval estimated using the Clopper Pearson method.|||0.701|0.075|
73896128|NCT02343549|147325757|OTHER|Estimation only|Disease Control Rate|1.0|||||TWO_SIDED|95.0|0.664|1.0||||||||1.000|0.664|
73810453|NCT02612610|147170099|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0009
73810454|NCT02612610|147170100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0037
73810455|NCT02612610|147170100|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0166
73810456|NCT02612610|147170100|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||<0.0001
73810457|NCT02612610|147170101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0396|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0396
73810458|NCT02612610|147170101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0751|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0751
73810459|NCT02612610|147170101|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0010
73810460|NCT02612610|147170102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for the gefapixant vs. placebo using CMH test."||||0.8464
73810461|NCT02612610|147170102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7687|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.7687
73810462|NCT02612610|147170102|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4364|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.4364
73810463|NCT02612610|147170103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9966|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.9966
73810464|NCT02612610|147170103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6372|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.6372
73896129|NCT02343549|147325758|OTHER|Estimation only.|Median|8.1|||||TWO_SIDED|95.0|3.7|8.6|||||The Kaplan Meier method was used to estimate median duration of response (in months). The Greenwood method was used to estimate confidence limits of median duration of response.|||8.6|3.7|
73896130|NCT02343549|147325759|OTHER|Estimation Only|Median|7.9|||||TWO_SIDED|95.0|4.8|10.4|||||The Kaplan Meier method was used to estimate median duration of disease control (in months). The Greenwood method was used to estimate confidence limits of median duration of disease control.|||10.4|4.8|
73896131|NCT05498701|147325762|OTHER||Ratios of Adjusted Geometric Means|93.19|||||TWO_SIDED|90.0|87.1|99.7||||||Bioequivalence of the Test treatment (Tafamidis free acid 12.2 mg oral tablet \[Fasted\]) to Reference treatment (Tafamidis meglumine 20 mg oral capsule \[Fasted\]) was concluded if the 90% confidence intervals for the ratios of adjusted geometric means for tafamidis AUCinf fell entirely within the acceptance region of (80%,125%).||99.70|87.10|
73896132|NCT05498701|147325763|OTHER||Ratio of Adjusted Geometric Means|81.0||||||90.0|76.25|86.04||||||Bioequivalence of the Test treatment (Tafamidis free acid 12.2 mg oral tablet \[Fasted\]) to Reference treatment (Tafamidis meglumine 20 mg oral capsule \[Fasted\]) was concluded if the 90% confidence intervals for the ratios of adjusted geometric means for tafamidis Cmax fell entirely within the acceptance region of (80%,125%).||86.04|76.25|
73896133|NCT01864005|147325764|SUPERIORITY_OR_OTHER|||||||0.0021||||||not adjusted for multiple comparisons. statistical significance level: 0.05|Wilcoxon (Mann-Whitney)|||||||0.0021
73896134|NCT01864005|147325764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.421||||0.0003|TWO_SIDED|95.0|18.559|58.283|||ANOVA|||||58.283|18.559|0.0003
73896135|NCT01864005|147325765|SUPERIORITY_OR_OTHER|||||||0.0828|||||||Wilcoxon (Mann-Whitney)|||||||0.0828
73896136|NCT01864005|147325766|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73896137|NCT01864005|147325767|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73896138|NCT01864005|147325768|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73896139|NCT02184572|147325772|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper limit of the 2-sided standardised asymptotic 95% Confidence Interval (CI) for the group difference (INV\_MMR minus COM\_MMR) in incidence of fever ≥ 39.0°C (≥ 102.2°F) should be equal to or below 5%.|Difference in incidence of fever|1.11|||||TWO_SIDED|95.0|-0.93|2.89||||||Difference between groups (INV\_MMR Group minus COM\_MMR Group) in incidence of fever \> 39.0°C.||2.89|-0.93|
73896140|NCT02184572|147325772|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper limit of the 2-sided standardised asymptotic 95% CI for the group difference (INV\_MMR minus COM\_MMR) in incidence of fever ≥ 38.0°C (≥ 100.4°F) should be equal to or below 10%.|Difference in incidence of fever|1.09|||||TWO_SIDED|95.0|-2.89|4.85||||||Difference between groups (INV\_MMR Group minus COM\_MMR Group) in incidence of fever \> 38.0°C.||4.85|-2.89|
73896141|NCT01328444|147325805|SUPERIORITY_OR_OTHER||Least squares mean difference|26.5||||0.321|TWO_SIDED|95.0|-25.9|78.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||78.9|-25.9|0.321
73896142|NCT01328444|147325805|SUPERIORITY_OR_OTHER||Least squares mean difference|13.1||||0.62|TWO_SIDED|95.0|-38.9|65.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||65.1|-38.9|0.620
73896143|NCT01328444|147325805|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.0||||0.665|TWO_SIDED|95.0|-55.5|35.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||35.4|-55.5|0.665
73896144|NCT01328444|147325805|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.6||||0.865|TWO_SIDED|95.0|-57.6|48.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||48.4|-57.6|0.865
73896145|NCT01328444|147325805|SUPERIORITY_OR_OTHER||Least squares mean difference|31.9||||0.174|TWO_SIDED|95.0|-14.1|77.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||77.9|-14.1|0.174
73896146|NCT01328444|147325805|SUPERIORITY_OR_OTHER||Least squares mean difference|19.3||||0.472|TWO_SIDED|95.0|-33.4|71.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||71.9|-33.4|0.472
73896147|NCT01328444|147325805|SUPERIORITY_OR_OTHER||Least squares mean difference|42.4||||0.072|TWO_SIDED|95.0|-3.8|88.7||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||88.7|-3.8|0.072
73896148|NCT01328444|147325805|SUPERIORITY_OR_OTHER||Least squares mean difference|21.9||||0.234|TWO_SIDED|95.0|-14.2|58.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||58.0|-14.2|0.234
73896149|NCT01328444|147325805|SUPERIORITY_OR_OTHER||Least squares mean difference|32.4||||0.08|TWO_SIDED|95.0|-3.9|68.8||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||68.8|-3.9|0.080
73896150|NCT01328444|147325806|SUPERIORITY_OR_OTHER||Least squares mean difference|0.087||||0.003|TWO_SIDED|95.0|0.03|0.143||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||0.143|0.030|0.003
73896151|NCT01328444|147325806|SUPERIORITY_OR_OTHER||Least squares mean difference|0.14|||<|0.001|TWO_SIDED|95.0|0.084|0.196||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||0.196|0.084|<0.001
73896152|NCT01328444|147325806|SUPERIORITY_OR_OTHER||Least squares mean difference|0.099|||<|0.001|TWO_SIDED|95.0|0.05|0.148||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||0.148|0.050|<0.001
73896153|NCT01328444|147325806|SUPERIORITY_OR_OTHER||Least squares mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.067|0.181||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||0.181|0.067|<0.001
73896154|NCT01328444|147325806|SUPERIORITY_OR_OTHER||Least squares mean difference|0.111|||<|0.001|TWO_SIDED|95.0|0.062|0.161||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.161|0.062|<0.001
73810465|NCT02612610|147170103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2155|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2155
73810466|NCT02612610|147170104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7559|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.7559
73810467|NCT02612610|147170104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5091|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.5091
73810468|NCT02612610|147170104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.279|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2790
73810469|NCT02612610|147170105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3887|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.3887
73810470|NCT02612610|147170105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2333|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2333
73810471|NCT02612610|147170105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0534|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.0534
73810472|NCT02612610|147170106|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6115|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.6115
73810473|NCT02612610|147170106|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
73810474|NCT02612610|147170106|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
73810475|NCT02612610|147170107|SUPERIORITY_OR_OTHER_LEGACY|||||||0||||||"A p-value of zero was calculated if all participants (100%) had No Taste Effect Noted or Not at All responses in both comparison groups."|Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0
73810476|NCT02612610|147170107|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
73810477|NCT02612610|147170107|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
73810478|NCT02783729|147170114|SUPERIORITY||Least Squares Geometric Mean(LSGM) Ratio|0.773|||=|0.0003|TWO_SIDED|95.0|0.672|0.889||Based on mixed effect model repeated measurement (MMRM) model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||||0.889|0.672|= 0.0003
73810479|NCT02783729|147170114|SUPERIORITY||LSGM Ratio|0.723|||<|0.0001|TWO_SIDED|95.0|0.628|0.832||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||||0.832|0.628|< 0.0001
73810480|NCT02783729|147170115|SUPERIORITY||Least Squares Mean (LSM) Difference|7.07|STANDARD_ERROR_OF_MEAN|0.746|<|0.0001|TWO_SIDED|95.0|5.61|8.54||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||||8.54|5.61|< 0.0001
73810481|NCT02783729|147170115|SUPERIORITY||LSM Difference|8.03|STANDARD_ERROR_OF_MEAN|0.746|<|0.0001|TWO_SIDED|95.0|6.57|9.49||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||||9.49|6.57|< 0.0001
73810482|NCT02783729|147170116|SUPERIORITY||LSM Difference|-23.96|STANDARD_ERROR_OF_MEAN|3.068|<|0.0001|TWO_SIDED|95.0|-29.98|-17.95||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||||-17.95|-29.98|< 0.0001
73810483|NCT02783729|147170116|SUPERIORITY||LSM Difference|-25.35|STANDARD_ERROR_OF_MEAN|3.067|<|0.0001|TWO_SIDED|95.0|-31.36|-19.34|||MMRM|||||-19.34|-31.36|< 0.0001
73810484|NCT02783729|147170117|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-6.65|STANDARD_ERROR_OF_MEAN|2.298|=|0.0038|TWO_SIDED|95.0|-11.15|-2.15|||MMRM|||||-2.15|-11.15|= 0.0038
73810485|NCT02783729|147170117|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.309|=|0.0005|TWO_SIDED|95.0|-12.53|-3.47|||MMRM|||||-3.47|-12.53|= 0.0005
73810486|NCT02783729|147170118|SUPERIORITY||LSM Difference|-9.63|STANDARD_ERROR_OF_MEAN|4.029|=|0.0171|TWO_SIDED|95.0|-17.53|-1.72||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 5 mg||-1.72|-17.53|= 0.0171
73810487|NCT02783729|147170118|SUPERIORITY||LSM Difference|-10.74|STANDARD_ERROR_OF_MEAN|4.04|=|0.008|TWO_SIDED|95.0|-18.67|-2.81||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 10 mg||-2.81|-18.67|= 0.008
73810488|NCT02783729|147170119|SUPERIORITY||LSGM Ratio|0.874|||=|0.0218|TWO_SIDED|95.0|0.78|0.981||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg||0.981|0.78|= 0.0218
73810489|NCT02783729|147170119|OTHER||LSGM Ratio|0.818|||=|0.0006|TWO_SIDED|95.0|0.729|0.917||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg||0.917|0.729|= 0.0006
73896155|NCT01328444|147325806|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.32|TWO_SIDED|95.0|-0.028|0.086||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.086|-0.028|0.320
73896156|NCT01328444|147325806|SUPERIORITY_OR_OTHER||Least squares mean difference|0.07||||0.007|TWO_SIDED|95.0|0.019|0.12||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.120|0.019|0.007
73810490|NCT02783729|147170119|SUPERIORITY||LSGM Ratio|0.634|||<|0.0001|TWO_SIDED|95.0|0.556|0.724||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg||0.724|0.556|< 0.0001
73810491|NCT02783729|147170119|SUPERIORITY||LSGM Ratio|0.594|||<|0.0001|TWO_SIDED|95.0|0.521|0.677||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg||0.677|0.521|< 0.0001
73810492|NCT02783729|147170119|SUPERIORITY||LSM Difference|-6.16|STANDARD_ERROR_OF_MEAN|2.544|=|0.0154|TWO_SIDED|95.0|-11.15|-1.17||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg||-1.17|-11.15|= 0.0154
73810493|NCT02783729|147170119|SUPERIORITY||LSM Difference|-15.03|STANDARD_ERROR_OF_MEAN|2.542|<|0.0001|TWO_SIDED|95.0|-20.01|-10.05||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 10 mg||-10.05|-20.01|< 0.0001
73810494|NCT02783729|147170119|SUPERIORITY||LSM Difference|-7.72|STANDARD_ERROR_OF_MEAN|2.876|=|0.0073|TWO_SIDED|95.0|-13.36|-2.08||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg||-2.08|-13.36|= 0.0073
73810495|NCT02783729|147170119|SUPERIORITY||LSM Difference|-9.1|STANDARD_ERROR_OF_MEAN|2.883|=|0.0016|TWO_SIDED|95.0|-14.75|-3.45|||MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg||-3.45|-14.75|= 0.0016
73810496|NCT02783729|147170119|SUPERIORITY||LSM Difference|10.25|STANDARD_ERROR_OF_MEAN|3.094|=|0.001|TWO_SIDED|95.0|4.18|16.32||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 5 mg||16.32|4.18|= 0.001
73810497|NCT02783729|147170119|SUPERIORITY||LSM Difference|23.1|STANDARD_ERROR_OF_MEAN|3.085|<|0.0001|TWO_SIDED|95.0|17.04|29.15||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 10 mg||29.15|17.04|< 0.0001
73810498|NCT02783729|147170119|SUPERIORITY||LSM Difference|19.41|STANDARD_ERROR_OF_MEAN|3.457|<|0.0001|TWO_SIDED|95.0|12.63|26.2||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 5 mg||26.2|12.63|< 0.0001
73810499|NCT02783729|147170119|SUPERIORITY||LSM Difference|24.1|STANDARD_ERROR_OF_MEAN|3.456|<|0.0001|TWO_SIDED|95.0|17.32|30.88||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 10 mg||30.88|17.32|< 0.0001
73896157|NCT01328444|147325806|SUPERIORITY_OR_OTHER||Least squares mean difference|0.211|||<|0.001|TWO_SIDED|95.0|0.172|0.249||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.249|0.172|<0.001
73896158|NCT01328444|147325806|SUPERIORITY_OR_OTHER||Least squares mean difference|0.169|||<|0.001|TWO_SIDED|95.0|0.129|0.209||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||0.209|0.129|<0.001
73896159|NCT00600119|147325815|SUPERIORITY_OR_OTHER|||||||0.7781|||||||Wilcoxon (Mann-Whitney)|||||||0.7781
73896160|NCT00600119|147325815|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.0020
73810500|NCT02783729|147170120|SUPERIORITY||LSGM Ratio|0.898|||=|0.0122|TWO_SIDED|95.0|0.825|0.977||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 5 mg||0.977|0.825|= 0.0122
73810501|NCT02783729|147170120|SUPERIORITY||LSGM Ratio|0.83|||<|0.0001|TWO_SIDED|95.0|0.763|0.902||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 10 mg||0.902|0.763|< 0.0001
73810502|NCT02783729|147170120|SUPERIORITY||LSGM Ratio|0.882|||=|0.0176|TWO_SIDED|95.0|0.796|0.978||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||0.978|0.796|= 0.0176
73810503|NCT02783729|147170120|SUPERIORITY||LSGM Ratio|0.811|||<|0.0001|TWO_SIDED|95.0|0.732|0.899||Based on MMRM model model with log transformation of sSOL and with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||0.899|0.732|< 0.0001
73810504|NCT02783729|147170120|SUPERIORITY||LSM Difference|8.12|STANDARD_ERROR_OF_MEAN|4.484|=|0.0706|TWO_SIDED|95.0|-0.68|16.91||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg||16.91|-0.68|= 0.0706
73810505|NCT02783729|147170120|SUPERIORITY||LSM Difference|-5.81|STANDARD_ERROR_OF_MEAN|4.481|=|0.1949|TWO_SIDED|95.0|-14.61|2.98||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 10 mg||2.98|-14.61|= 0.1949
73896161|NCT00600119|147325815|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
73896162|NCT00600119|147325816|SUPERIORITY_OR_OTHER|||||||0.5118|||||||Wilcoxon (Mann-Whitney)|||||||0.5118
73896163|NCT00600119|147325816|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||||||0.0022
73810506|NCT02783729|147170120|SUPERIORITY||LSM Difference|14.45|STANDARD_ERROR_OF_MEAN|5.241|=|0.0059|TWO_SIDED|95.0|4.16|24.73||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||24.73|4.16|= 0.0059
73810507|NCT02783729|147170120|SUPERIORITY||LSM Difference|5.36|STANDARD_ERROR_OF_MEAN|5.241|=|0.3064|TWO_SIDED|95.0|-4.92|15.65||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||15.65|-4.92|= 0.3064
73810508|NCT02783729|147170120|SUPERIORITY||LSM Difference|-6.57|STANDARD_ERROR_OF_MEAN|5.325|=|0.2174|TWO_SIDED|95.0|-17.02|3.88||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 5 mg||3.88|-17.02|= 0.2174
73810509|NCT02783729|147170120|SUPERIORITY||LSM Difference|8.88|STANDARD_ERROR_OF_MEAN|5.313|=|0.0949|TWO_SIDED|95.0|-1.55|19.31||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 10 mg||19.31|-1.55|= 0.0949
73810510|NCT02783729|147170120|SUPERIORITY||LSM Difference|-6.82|STANDARD_ERROR_OF_MEAN|6.207|=|0.2718|TWO_SIDED|95.0|-19.01|5.36||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||5.36|-19.01|= 0.2718
73810511|NCT02783729|147170120|SUPERIORITY||LSM Difference|7.43|STANDARD_ERROR_OF_MEAN|6.206|=|0.2317|TWO_SIDED|95.0|-4.75|19.61||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||19.61|-4.75|= 0.2317
73810512|NCT02783729|147170121|SUPERIORITY||LSM Difference|-1.37|STANDARD_ERROR_OF_MEAN|1.063|=|0.1963|TWO_SIDED|95.0|-3.46|0.71||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 5 mg||0.71|-3.46|= 0.1963
73810513|NCT02783729|147170121|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate|LSM Difference|1.7|STANDARD_ERROR_OF_MEAN|1.06|=|0.1093|TWO_SIDED|95.0|-0.38|3.78|||MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 10 mg||3.78|-0.38|= 0.1093
73810514|NCT02783729|147170121|SUPERIORITY||LSM Difference|-1.53|STANDARD_ERROR_OF_MEAN|1.247|=|0.2196|TWO_SIDED|95.0|-3.98|0.92||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||0.92|-3.98|= 0.2196
73810515|NCT02783729|147170121|SUPERIORITY||LSM Difference|1.05|STANDARD_ERROR_OF_MEAN|1.246|=|0.4013|TWO_SIDED|95.0|-1.4|3.49||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||3.49|-1.4|= 0.4013
73896164|NCT00600119|147325816|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73896165|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.5522||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5522
73896166|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.0589||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0589
73896167|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.1691||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1691
73810516|NCT02783729|147170122|SUPERIORITY||LSGM Ratio|0.85|||=|0.0092|TWO_SIDED|95.0|0.752|0.961||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 5 mg||0.961|0.752|= 0.0092
73810517|NCT02783729|147170122|SUPERIORITY||LSGM Ratio|0.795|||=|0.0002|TWO_SIDED|95.0|0.704|0.899||Based on MMRM model with factors of age group, region, treatment, visit (Days1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 10 mg||0.899|0.704|= 0.0002
73810518|NCT02783729|147170122|SUPERIORITY||LSM Difference|-33.4|STANDARD_ERROR_OF_MEAN|2.711|<|0.0001|TWO_SIDED|95.0|-38.71|-28.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 5 mg||-28.09|-38.71|< 0.0001
73810519|NCT02783729|147170122|SUPERIORITY||LSM Difference|-42.27|STANDARD_ERROR_OF_MEAN|2.705|<|0.0001|TWO_SIDED|95.0|-47.57|-36.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 10 mg||-36.97|-47.57|< 0.0001
73810520|NCT02783729|147170122|SUPERIORITY||LSM Difference|-21.66|STANDARD_ERROR_OF_MEAN|2.221|<|0.0001|TWO_SIDED|95.0|-26.01|-17.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg||-17.3|-26.01|< 0.0001
73810521|NCT02783729|147170122|SUPERIORITY||LSM Difference|-28.33|STANDARD_ERROR_OF_MEAN|2.219|<|0.0001|TWO_SIDED|95.0|-32.68|-23.98||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg||-23.98|-32.68|< 0.0001
73810522|NCT02783729|147170122|SUPERIORITY||LSM Difference|44.05|STANDARD_ERROR_OF_MEAN|3.291|<|0.0001|TWO_SIDED|95.0|37.59|50.51||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg||50.51|37.59|< 0.0001
73810523|NCT02783729|147170122|SUPERIORITY||LSM Difference|56.9|STANDARD_ERROR_OF_MEAN|3.284|<|0.0001|TWO_SIDED|95.0|50.46|63.34||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg||63.34|50.46|< 0.0001
73810524|NCT02783729|147170123|SUPERIORITY||LSM Difference|9.01|STANDARD_ERROR_OF_MEAN|0.666|<|0.0001|TWO_SIDED|95.0|7.7|10.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 5 mg||10.31|7.7|< 0.0001
73896168|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.6293||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.6293
73810525|NCT02783729|147170123|SUPERIORITY||LSM Difference|11.6|STANDARD_ERROR_OF_MEAN|0.664|<|0.0001|TWO_SIDED|95.0|10.3|12.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 10 mg||12.9|10.3|< 0.0001
73896169|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.0836||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0836
73896170|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.1155||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1155
73810526|NCT02783729|147170124|SUPERIORITY||LSM Difference|-16.41|STANDARD_ERROR_OF_MEAN|2.457|<|0.0001|TWO_SIDED|95.0|-21.23|-11.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg||-11.6|-21.23|< 0.0001
73810527|NCT02783729|147170124|SUPERIORITY||LSM Difference|-17.76|STANDARD_ERROR_OF_MEAN|2.451|<|0.0001|TWO_SIDED|95.0|-22.57|-12.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg||-12.96|-22.57|< 0.0001
73810528|NCT02783729|147170124|SUPERIORITY||LSM Difference|34.16|STANDARD_ERROR_OF_MEAN|3.673|<|0.0001|TWO_SIDED|95.0|26.95|41.36||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg||41.36|26.95|< 0.0001
73810529|NCT02783729|147170124|SUPERIORITY||LSM Difference|38.85|STANDARD_ERROR_OF_MEAN|3.672|<|0.0001|TWO_SIDED|95.0|31.64|46.05||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg||46.05|31.64|< 0.0001
73810530|NCT02783729|147170125|SUPERIORITY||LSGM Ratio|0.815|||<|0.0001|TWO_SIDED|95.0|0.745|0.891||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg||0.891|0.745|< 0.0001
73810531|NCT02783729|147170125|SUPERIORITY||LSGM Ratio|0.753|||<|0.0001|TWO_SIDED|95.0|0.689|0.823||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg||0.823|0.689|< 0.0001
73810532|NCT02783729|147170125|SUPERIORITY||LSGM Ratio|0.75|||<|0.0001|TWO_SIDED|95.0|0.671|0.837||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg||0.837|0.671|< 0.0001
73896171|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.9938||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.9938
73896172|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.2101||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.2101
73810533|NCT02783729|147170125|SUPERIORITY||LSGM Ratio|0.689|||<|0.0001|TWO_SIDED|95.0|0.618|0.769||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg||0.769|0.618|< 0.0001
73810534|NCT02783729|147170125|SUPERIORITY||LSM Difference|-12.41|STANDARD_ERROR_OF_MEAN|4.764|=|0.0093|TWO_SIDED|95.0|-21.76|-3.06||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 5 mg||-3.06|-21.76|= 0.0093
73810535|NCT02783729|147170125|SUPERIORITY||LSM Difference|-26.34|STANDARD_ERROR_OF_MEAN|4.762|<|0.0001|TWO_SIDED|95.0|-35.68|-16.99||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg||-16.99|-35.68|< 0.0001
73810536|NCT02783729|147170125|SUPERIORITY||LSM Difference|-11.49|STANDARD_ERROR_OF_MEAN|5.573|=|0.0396|TWO_SIDED|95.0|-22.42|-0.55||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg||-0.55|-22.42|= 0.0396
73810537|NCT02783729|147170125|SUPERIORITY||LSM Difference|-20.57|STANDARD_ERROR_OF_MEAN|5.574|=|0.0002|TWO_SIDED|95.0|-31.51|-9.63||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg||-9.63|-31.51|= 0.0002
73810538|NCT02783729|147170125|SUPERIORITY||LSM Difference|19.05|STANDARD_ERROR_OF_MEAN|5.619|=|0.0007|TWO_SIDED|95.0|8.03|30.08||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 5 mg||30.08|8.03|= 0.0007
73810539|NCT02783729|147170125|SUPERIORITY||LSM Difference|34.51|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|23.5|45.52||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 10 mg||45.52|23.5|< 0.0001
73810540|NCT02783729|147170125|SUPERIORITY||LSM Difference|23.57|STANDARD_ERROR_OF_MEAN|6.565|=|0.0003|TWO_SIDED|95.0|10.68|36.45||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 5 mg||36.45|10.68|= 0.0003
73810541|NCT02783729|147170125|SUPERIORITY||LSM Difference|37.82|STANDARD_ERROR_OF_MEAN|6.565|<|0.0001|TWO_SIDED|95.0|24.94|50.71||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 10 mg||50.71|24.94|< 0.0001
73810542|NCT02783729|147170126|SUPERIORITY||LSM Difference|3.76|STANDARD_ERROR_OF_MEAN|1.122|=|0.0008|TWO_SIDED|95.0|1.56|5.97||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 5 mg||5.97|1.56|= 0.0008
73810543|NCT02783729|147170126|SUPERIORITY||LSM Difference|6.84|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|4.64|9.04||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 10 mg||9.04|4.64|< 0.0001
73896173|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.4597||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.4597
73810544|NCT02783729|147170126|SUPERIORITY||LSM Difference|4.61|STANDARD_ERROR_OF_MEAN|1.319|=|0.0005|TWO_SIDED|95.0|2.02|7.19||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 5 mg||7.19|2.02|= 0.0005
73810545|NCT02783729|147170126|SUPERIORITY||LSM Difference|7.18|STANDARD_ERROR_OF_MEAN|1.319|<|0.0001|TWO_SIDED|95.0|4.6|9.77||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 10 mg||9.77|4.6|< 0.0001
73810546|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|0.41|||=|0.9028|TWO_SIDED|95.0|-6.22|7.04||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 5 mg||7.04|-6.22|= 0.9028
73810547|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|2.49|||=|0.4699|TWO_SIDED|95.0|-4.2|9.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 10 mg||9.18|-4.2|= 0.4699
73810548|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|5.58|||=|0.0566|TWO_SIDED|95.0|-0.14|11.31|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by age group.||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg||11.31|-0.14|= 0.0566
73810549|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|7.57|||=|0.0122|TWO_SIDED|95.0|1.71|13.44||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg||13.44|1.71|= 0.0122
73810550|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|4.42|||=|0.2176|TWO_SIDED|95.0|-2.5|11.34||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 5 mg||11.34|-2.5|= 0.2176
73810551|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|6.47|||=|0.0773|TWO_SIDED|95.0|-0.55|13.49||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 10 mg||13.49|-0.55|= 0.0773
73810552|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|8.85|||=|0.0054|TWO_SIDED|95.0|2.68|15.02||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg||15.02|2.68|= 0.0054
73810553|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|10.89|||=|0.0008|TWO_SIDED|95.0|4.61|17.17||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg||17.17|4.61|= 0.0008
73810554|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|6.9|||=|0.003|TWO_SIDED|95.0|2.66|11.14||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg||11.14|2.66|= 0.003
73810555|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|7.5|||=|0.0016|TWO_SIDED|95.0|3.19|11.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg||11.81|3.19|= 0.0016
73810556|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|2.22|||=|0.3643|TWO_SIDED|95.0|-2.56|7.01||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 5 mg||7.01|-2.56|= 0.3643
73810557|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|2.82|||=|0.2553|TWO_SIDED|95.0|-2.02|7.66||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 10 mg||7.66|-2.02|= 0.2553
73810558|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|9.69|||=|0.0016|TWO_SIDED|95.0|3.98|15.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg||15.4|3.98|= 0.0016
73810559|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|7.29|||=|0.0128|TWO_SIDED|95.0|1.8|12.79||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg||12.79|1.8|= 0.0128
73810560|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|8.16|||=|0.0051|TWO_SIDED|95.0|2.51|13.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||13.81|2.51|= 0.0051
73810561|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|5.76|||=|0.0389|TWO_SIDED|95.0|0.34|11.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7nights: Zolpidem ER, Lemborexant 10 mg||11.18|0.34|= 0.0389
73810562|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|34.26|||<|0.0001|TWO_SIDED|95.0|26.46|42.06||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 5 mg||42.06|26.46|< 0.0001
73810563|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|47.57|||<|0.0001|TWO_SIDED|95.0|40.02|55.13||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 10 mg||55.13|40.02|< 0.0001
73810564|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|4.89|||=|0.2534|TWO_SIDED|95.0|-3.49|13.28||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg||13.28|-3.49|= 0.2534
73810565|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|18.25|||<|0.0001|TWO_SIDED|95.0|10.1|26.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO: Days 1/2: Zolpidem ER, Lemborexant 10 mg||26.4|10.1|< 0.0001
73810566|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|22.2|||<|0.0001|TWO_SIDED|95.0|14.06|30.35||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 5 mg||30.35|14.06|< 0.0001
73810567|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|24.13|||<|0.0001|TWO_SIDED|95.0|16.16|32.1||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 10 mg||32.1|16.16|< 0.0001
73810568|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|9.59|||=|0.023|TWO_SIDED|95.0|1.36|17.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg||17.81|1.36|= 0.023
73810569|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|11.43|||=|0.0058|TWO_SIDED|95.0|3.38|19.48||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg||19.48|3.38|= 0.0058
73810570|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|7.3|||=|0.0222|TWO_SIDED|95.0|1.27|13.33||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 5||13.33|1.27|= 0.0222
73810571|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|10.84|||=|0.0013|TWO_SIDED|95.0|4.57|17.11||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg||17.11|4.57|= 0.0013
73810572|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|0.21|||=|0.9495|TWO_SIDED|95.0|-6.17|6.58||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg||6.58|-6.17|= 0.9495
73810573|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|3.72|||=|0.2708|TWO_SIDED|95.0|-2.88|10.32||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO: First 7 nights: Zolpidem ER, Lemborexant 10 mg||10.32|-2.88|= 0.2708
73810574|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|7.91|||=|0.0322|TWO_SIDED|95.0|0.86|14.96||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg||14.96|0.86|= 0.0322
73810575|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|7.69|||=|0.0363|TWO_SIDED|95.0|0.68|14.71||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg||14.71|0.68|= 0.0363
73810576|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|0.05|||=|0.9885|TWO_SIDED|95.0|-7.14|7.24||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||7.24|-7.14|= 0.9885
73810577|NCT02783729|147170127|SUPERIORITY||Difference of Percentage|-0.16|||=|0.9651|TWO_SIDED|95.0|-7.31|6.99||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||6.99|-7.31|= 0.9651
73810578|NCT02783729|147170128|SUPERIORITY||LSM Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.319|=|0.0006|TWO_SIDED|95.0|-1.73|-0.47||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg||-0.47|-1.73|= 0.0006
73810579|NCT02783729|147170128|SUPERIORITY||LSM Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.32|=|0.0007|TWO_SIDED|95.0|-1.71|-0.46||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg||-0.46|-1.71|= 0.0007
73896174|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.4822||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.4822
73896175|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.0171||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0171
73810580|NCT02783729|147170128|SUPERIORITY||LSM Difference|0.32|STANDARD_ERROR_OF_MEAN|0.301|=|0.2951|TWO_SIDED|95.0|-0.28|0.91||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg||0.91|-0.28|= 0.2951
73810581|NCT02783729|147170128|SUPERIORITY||LSM Difference|0.33|STANDARD_ERROR_OF_MEAN|0.303|=|0.2744|TWO_SIDED|95.0|-0.26|0.92||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg||0.92|-0.26|= 0.2744
73810582|NCT02783729|147170129|SUPERIORITY||LSM Difference|-1.26|STANDARD_ERROR_OF_MEAN|1.063|=|0.2348|TWO_SIDED|95.0|-3.35|0.82||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg||0.82|-3.35|= 0.2348
73810583|NCT02783729|147170129|SUPERIORITY||LSM Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.067|=|0.2745|TWO_SIDED|95.0|-3.26|0.93||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg||0.93|-3.26|= 0.2745
73810584|NCT02783729|147170129|SUPERIORITY||LSM Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.005|=|0.711|TWO_SIDED|95.0|-2.35|1.6||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg||1.6|-2.35|= 0.711
73810585|NCT02783729|147170129|SUPERIORITY||LSM Difference|-0.27|STANDARD_ERROR_OF_MEAN|1.009|=|0.7854|TWO_SIDED|95.0|-2.26|1.71||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg||1.71|-2.26|= 0.7854
73810586|NCT02783729|147170130|SUPERIORITY||LSM Difference|30.77|STANDARD_ERROR_OF_MEAN|12.505|=|0.0141|TWO_SIDED|95.0|6.23|55.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 5 mg||55.31|6.23|= 0.0141
73810587|NCT02783729|147170130|SUPERIORITY||LSM Difference|39.67|STANDARD_ERROR_OF_MEAN|12.542|=|0.0016|TWO_SIDED|95.0|15.05|64.29||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 10 mg||64.29|15.05|= 0.0016
73810588|NCT02783729|147170130|SUPERIORITY||LSM Difference|-19.22|STANDARD_ERROR_OF_MEAN|11.779|=|0.1031|TWO_SIDED|95.0|-42.34|3.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 5 mg||3.9|-42.34|= 0.1031
73810589|NCT02783729|147170130|SUPERIORITY||LSM Difference|-10.32|STANDARD_ERROR_OF_MEAN|11.813|=|0.3825|TWO_SIDED|95.0|-33.5|12.86||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 10 mg||12.86|-33.5|= 0.3825
73810590|NCT02783729|147170130|SUPERIORITY||LSM Difference|28.81|STANDARD_ERROR_OF_MEAN|60.626|=|0.6348|TWO_SIDED|95.0|-90.18|147.8||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 5 mg||147.8|-90.18|= 0.6348
73810591|NCT02783729|147170130|SUPERIORITY||LSM Difference|50.83|STANDARD_ERROR_OF_MEAN|60.702|=|0.4026|TWO_SIDED|95.0|-68.3|169.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 10 mg||169.97|-68.3|= 0.4026
73810592|NCT02783729|147170130|SUPERIORITY||LSM Difference|-203.36|STANDARD_ERROR_OF_MEAN|57.171|=|0.0004|TWO_SIDED|95.0|-315.56|-91.15||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 5 mg||-91.15|-315.56|= 0.0004
73810593|NCT02783729|147170130|SUPERIORITY||LSM Difference|-181.33|STANDARD_ERROR_OF_MEAN|57.255|=|0.0016|TWO_SIDED|95.0|-293.71|-68.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 10 mg||-68.96|-293.71|= 0.0016
73810594|NCT02783729|147170131|SUPERIORITY||LSM Difference|-0.03|STANDARD_ERROR_OF_MEAN|4.141|=|0.9936|TWO_SIDED|95.0|-8.16|8.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 5 mg||8.09|-8.16|= 0.9936
73810595|NCT02783729|147170131|SUPERIORITY||LSM Difference|-5.85|STANDARD_ERROR_OF_MEAN|4.154|=|0.1595|TWO_SIDED|95.0|-14.0|2.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 10 mg||2.3|-14|= 0.1595
73810596|NCT02783729|147170131|SUPERIORITY||LSM Difference|12.73|STANDARD_ERROR_OF_MEAN|3.894|=|0.0011|TWO_SIDED|95.0|5.09|20.38||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 5 mg||20.38|5.09|= 0.0011
73896176|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.016||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0160
73896177|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.6857||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.6857
73810597|NCT02783729|147170131|SUPERIORITY||LSM Difference|6.92|STANDARD_ERROR_OF_MEAN|3.913|=|0.0774|TWO_SIDED|95.0|-0.76|14.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 10 mg||14.6|-0.76|= 0.0774
73896178|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.0253||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0253
73896179|NCT00600119|147325817|SUPERIORITY_OR_OTHER|||||||0.0772||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0772
73896180|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.5008||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5008
73810598|NCT02783729|147170131|SUPERIORITY||LSM Difference|0.35|STANDARD_ERROR_OF_MEAN|0.393|=|0.3726|TWO_SIDED|95.0|-0.42|1.12||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 5 mg||1.12|-0.42|= 0.3726
73810599|NCT02783729|147170131|SUPERIORITY||LSM Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.394|=|0.2579|TWO_SIDED|95.0|-1.22|0.33||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 10 mg||0.33|-1.22|= 0.2579
73810600|NCT02783729|147170131|SUPERIORITY||LSM Difference|1.39|STANDARD_ERROR_OF_MEAN|0.37|=|0.0002|TWO_SIDED|95.0|0.66|2.11||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 5 mg||2.11|0.66|= 0.0002
73810601|NCT02783729|147170131|SUPERIORITY||LSM Difference|0.59|STANDARD_ERROR_OF_MEAN|0.372|=|0.112|TWO_SIDED|95.0|-0.14|1.32||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 10 mg||1.32|-0.14|= 0.112
73810602|NCT05127304|147170136|OTHER|||||||0.639|||||||Weighted clustered linear regression|||Ambulatory visits||||0.639
73810603|NCT05127304|147170136|OTHER|||||||0.535|||||||Weighted clustered linear regression|||Office visits||||0.535
73810604|NCT05127304|147170136|OTHER|||||||0.337|||||||Weighted clustered linear regression|||Outpatient visits||||0.337
73810605|NCT05127304|147170136|OTHER|||||||0.058|||||||Weighted clustered linear regression|||Emergency room visits||||0.058
73810606|NCT05127304|147170136|OTHER|||||||0.192|||||||Weighted clustered linear regression|||Inpatient visits||||0.192
73810607|NCT05127304|147170136|OTHER|||||||0.176|||||||Weighted clustered linear regression|||Other medical visits||||0.176
73810608|NCT05127304|147170137|OTHER|||||||0.313|||||||Weighted clustered linear regression|||||||0.313
73810609|NCT05127304|147170138|OTHER|||||||0.021|||||||Weighted clustered linear regression|||||||0.021
73810610|NCT05127304|147170139|OTHER|||||||0.022|||||||Weighted clustered linear regression|||Ambulatory visits||||0.022
73810611|NCT05127304|147170139|OTHER|||||||0.124|||||||Weighted clustered linear regression|||Office visits||||0.124
73810612|NCT05127304|147170139|OTHER|||||||0.043|||||||Weighted clustered linear regression|||Outpatient visits||||0.043
73810613|NCT05127304|147170139|OTHER|||||||0.99|||||||Weighted clustered linear regression|||Emergency room visits||||0.990
73810614|NCT05127304|147170139|OTHER|||||||0.039|||||||Weighted clustered linear regression|||Inpatient visits||||0.039
73810615|NCT05127304|147170139|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Other medical visits||||<0.001
73810616|NCT05127304|147170140|OTHER|||||||0.163|||||||Weighted clustered linear regression|||||||0.163
73810617|NCT05127304|147170141|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
73810618|NCT05127304|147170142|OTHER|||||||0.017|||||||Weighted clustered linear regression|||Ambulatory visits||||0.017
73810619|NCT05127304|147170142|OTHER|||||||0.098|||||||Weighted clustered linear regression|||Office visits||||0.098
73810620|NCT05127304|147170142|OTHER|||||||0.036|||||||Weighted clustered linear regression|||Outpatient visits||||0.036
73810621|NCT05127304|147170142|OTHER|||||||0.894|||||||Weighted clustered linear regression|||Emergency room visits||||0.894
73810622|NCT05127304|147170142|OTHER|||||||0.036|||||||Weighted clustered linear regression|||Inpatient visits||||0.036
73810623|NCT05127304|147170142|OTHER|||||||0.001|||||||Weighted clustered linear regression|||Other medical visits||||0.001
73810624|NCT05127304|147170143|OTHER|||||||0.162|||||||Weighted clustered linear regression|||||||0.162
73810625|NCT05127304|147170144|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
73810626|NCT05127304|147170145|OTHER|||||||0.065|||||||Weighted clustered linear regression|||Ambulatory visits||||0.065
73810627|NCT05127304|147170145|OTHER|||||||0.102|||||||Weighted clustered linear regression|||Office visits||||0.102
73810628|NCT05127304|147170145|OTHER|||||||0.1|||||||Weighted clustered linear regression|||Outpatient visits||||0.100
73810629|NCT05127304|147170145|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Emergency room visits||||0.189
73810630|NCT05127304|147170145|OTHER|||||||0.024|||||||Weighted clustered linear regression|||Inpatient visits||||0.024
73810631|NCT05127304|147170145|OTHER|||||||0.767|||||||Weighted clustered linear regression|||Other medical visits||||0.767
73810632|NCT05127304|147170146|OTHER|||||||0.357|||||||Weighted clustered linear regression|||||||0.357
73810633|NCT05127304|147170147|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Ambulatory visits||||0.002
73810634|NCT05127304|147170147|OTHER|||||||0.42|||||||Weighted clustered linear regression|||Office visits||||0.420
73810635|NCT05127304|147170147|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Outpatient visits||||0.002
73810636|NCT05127304|147170147|OTHER|||||||0.304|||||||Weighted clustered linear regression|||Emergency room visits||||0.304
73810637|NCT05127304|147170147|OTHER|||||||0.326|||||||Weighted clustered linear regression|||Inpatient visits||||0.326
73810638|NCT05127304|147170147|OTHER|||||||0.007|||||||Weighted clustered linear regression|||Other medical visits||||0.007
73810639|NCT05127304|147170148|OTHER|||||||0.52|||||||Weighted clustered linear regression|||||||0.520
73810640|NCT05127304|147170149|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
73810641|NCT05127304|147170150|OTHER|||||||0.06|||||||Weighted clustered linear regression|||Medical costs||||0.060
73810642|NCT05127304|147170150|OTHER|||||||0.177|||||||Weighted clustered linear regression|||Ambulatory costs||||0.177
73810643|NCT05127304|147170150|OTHER|||||||0.834|||||||Weighted clustered linear regression|||Office visits costs||||0.834
73810644|NCT05127304|147170150|OTHER|||||||0.121|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.121
73810645|NCT05127304|147170150|OTHER|||||||0.159|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.159
73810646|NCT05127304|147170150|OTHER|||||||0.289|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.289
73810647|NCT05127304|147170150|OTHER|||||||0.055|||||||Weighted clustered linear regression|||Other medical costs||||0.055
73810648|NCT05127304|147170150|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
73810649|NCT05127304|147170150|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
73810650|NCT05127304|147170151|OTHER|||||||0.066|||||||Weighted clustered linear regression|||Medical costs||||0.066
73810651|NCT05127304|147170151|OTHER|||||||0.193|||||||Weighted clustered linear regression|||Ambulatory costs||||0.193
73810652|NCT05127304|147170151|OTHER|||||||0.117|||||||Weighted clustered linear regression|||Office visits costs||||0.117
73810653|NCT05127304|147170151|OTHER|||||||0.25|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.250
73810654|NCT05127304|147170151|OTHER|||||||0.431|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.431
73810655|NCT05127304|147170151|OTHER|||||||0.129|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.129
73810656|NCT05127304|147170151|OTHER|||||||0.236|||||||Weighted clustered linear regression|||Other medical costs||||0.236
73810657|NCT05127304|147170151|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
73810658|NCT05127304|147170151|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
73810659|NCT05127304|147170152|OTHER|||||||0.057|||||||Weighted clustered linear regression|||Medical costs||||0.057
73810660|NCT05127304|147170152|OTHER|||||||0.182|||||||Weighted clustered linear regression|||Ambulatory costs||||0.182
73810661|NCT05127304|147170152|OTHER|||||||0.083|||||||Weighted clustered linear regression|||Office visits costs||||0.083
73810662|NCT05127304|147170152|OTHER|||||||0.245|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.245
73810663|NCT05127304|147170152|OTHER|||||||0.386|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.386
73810664|NCT05127304|147170152|OTHER|||||||0.115|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.115
73810665|NCT05127304|147170152|OTHER|||||||0.237|||||||Weighted clustered linear regression|||Other medical costs||||0.237
73810666|NCT05127304|147170152|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
73810667|NCT05127304|147170152|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
73810668|NCT05127304|147170153|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Medical costs||||0.189
73810669|NCT05127304|147170153|OTHER|||||||0.314|||||||Weighted clustered linear regression|||Ambulatory costs||||0.314
73810670|NCT05127304|147170153|OTHER|||||||0.203|||||||Weighted clustered linear regression|||Office visits costs||||0.203
73810671|NCT05127304|147170153|OTHER|||||||0.379|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.379
73896181|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.1823||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1823
73810672|NCT05127304|147170153|OTHER|||||||0.815|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.815
73810673|NCT05127304|147170153|OTHER|||||||0.205|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.205
73810674|NCT05127304|147170153|OTHER|||||||0.556|||||||Weighted clustered linear regression|||Other medical costs||||0.556
73810675|NCT05127304|147170153|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||0.189
73810676|NCT05127304|147170154|OTHER|||||||0.483|||||||Weighted clustered linear regression|||Medical costs||||0.483
73810677|NCT05127304|147170154|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Ambulatory costs||||0.002
73810678|NCT05127304|147170154|OTHER|||||||0.123|||||||Weighted clustered linear regression|||Office visits costs||||0.123
73810679|NCT05127304|147170154|OTHER|||||||0.003|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.003
73810680|NCT05127304|147170154|OTHER|||||||0.17|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.170
73810681|NCT05127304|147170154|OTHER|||||||0.582|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.582
73810682|NCT05127304|147170154|OTHER|||||||0.887|||||||Weighted clustered linear regression|||Other medical costs||||0.887
73810683|NCT05127304|147170154|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
73810684|NCT05127304|147170154|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
73810685|NCT05127304|147170155|OTHER|||||||0.205|||||||Weighted clustered linear regression|||Any COPD exacerbation||||0.205
73810686|NCT05127304|147170155|OTHER|||||||0.454|||||||Weighted clustered linear regression|||Severe COPD exacerbation||||0.454
73810687|NCT05127304|147170156|OTHER|||||||0.06|||||||Rao-Scott test|||||||0.060
73810688|NCT01623037|147170269|OTHER||sucess proportion|71.1|||||TWO_SIDED|95.0|55.7|83.6||||||||83.6|55.7|
73810689|NCT01203826|147170274|OTHER|||||||0.0005|||||||Wilcoxon signed-rank test|P-value based on Wilcoxon signed-rank test.||Change is relative to Baseline in Study ENB-006-09 (NCT00952484). The RGI-C score represents evaluations of skeletal X-rays at each post-treatment study timepoint in Study ENB-008-10 compared with pre-treatment X-rays from Study ENB-006-09, using an ordinal scale. Therefore, no Baseline data for RGI-C are available.||||0.0005
73810690|NCT05870956|147170293|OTHER||Mean Difference (Net)|932.88||||0.516|TWO_SIDED|95.0|-1880.17|3745.94|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||3745.94|-1880.17|0.516
73810691|NCT05870956|147170293|OTHER||Mean Difference (Net)|4902.02||||0.02|TWO_SIDED|95.0|767.6|9036.43|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||9036.43|767.60|0.020
73810692|NCT05870956|147170293|OTHER||Mean Difference (Net)|2727.38||||0.026|TWO_SIDED|95.0|323.48|5131.27|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5131.27|323.48|0.026
73810693|NCT05870956|147170293|OTHER||Mean Difference (Net)|5462.41||||0|TWO_SIDED|95.0|2520.93|8403.9|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8403.90|2520.93|0.000
73810694|NCT05870956|147170294|OTHER||Mean Difference (Net)|-303.94||||0.439|TWO_SIDED|95.0|-1074.77|466.9|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||466.90|-1074.77|0.439
73810695|NCT05870956|147170294|OTHER||Mean Difference (Net)|2772.06||||0.021|TWO_SIDED|95.0|422.1|5122.02|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5122.02|422.10|0.021
73810696|NCT05870956|147170294|OTHER||Mean Difference (Net)|456.79||||0.328|TWO_SIDED|95.0|-458.64|1372.21|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||1372.21|-458.64|0.328
73810697|NCT05870956|147170294|OTHER||Mean Difference (Net)|620.87||||0.382|TWO_SIDED|95.0|-771.77|2013.51|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||2013.51|-771.77|0.382
73810698|NCT05870956|147170295|OTHER||Mean Difference (Net)|2.4||||0.463|TWO_SIDED|95.0|-4.0|8.9|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8.9|-4.0|0.463
73810699|NCT05870956|147170295|OTHER||Mean Difference (Net)|9.6||||0.008|TWO_SIDED|95.0|2.5|16.8|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||16.8|2.5|0.008
73810700|NCT05870956|147170295|OTHER||Mean Difference (Net)|9.1||||0.005|TWO_SIDED|95.0|2.8|15.3|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||15.3|2.8|0.005
73810701|NCT05870956|147170295|OTHER||Mean Difference (Net)|6.4||||0.019|TWO_SIDED|95.0|1.1|11.7|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||11.7|1.1|0.019
73810702|NCT05870956|147170296|OTHER||Mean Difference (Net)|0.6||||0.801|TWO_SIDED|95.0|-4.3|5.5|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5.5|-4.3|0.801
73810703|NCT05870956|147170296|OTHER||Mean Difference (Net)|8.7||||0.005|TWO_SIDED|95.0|2.7|14.8|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||14.8|2.7|0.005
73810704|NCT05870956|147170296|OTHER||Mean Difference (Net)|3.4||||0.17|TWO_SIDED|95.0|-1.4|8.2|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8.2|-1.4|0.170
73810705|NCT05870956|147170296|OTHER||Mean Difference (Net)|1.4||||0.489|TWO_SIDED|95.0|-2.6|5.4|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5.4|-2.6|0.489
73810706|NCT02880865|147170303|NON_INFERIORITY|Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10% for both measles and rubella results.|Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2||||||The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.||2.2|-2.1|
73810707|NCT02880865|147170304|NON_INFERIORITY|Non-inferiority was achieved if the lower limit of the two-sided 95% CI for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10% for both measles and rubella results.|Difference|0.3|||||TWO_SIDED|95.0|-0.3|1.0||||||The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.||1.0|-0.3|
73810708|NCT02880865|147170305|NON_INFERIORITY|The percentage of participants with seropositivity for mumps at 56 days post-vaccination between Group 1 and Group 2 were compared using a non-inferiority test. Non-inferiority of Group 1 to Group 2 in terms of seropositivity for mumps was demonstrated if the lower limit of the two-sided 95% CI for the difference of seropositivity rates between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.1||||||||2.1|-2.0|
73810709|NCT02880865|147170306|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.2|||||Group 1/Group 2 ratio obtained using analysis of covariance (ANCOVA) with log10-transformed antibody concentration as dependent variable and treatment group as the explanatory variable adjusted for log10-transformed baseline antibody concentration.|||1.2|0.9|
73810710|NCT02880865|147170307|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.1|||||Group 1/Group 2 ratio obtained using an ANCOVA method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody concentration.|||1.1|0.9|
73810711|NCT02880865|147170308|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2|||||Group 1 - Group 2|||2.2|-2.1|
73810712|NCT02880865|147170309|OTHER||Difference|1.6|||||TWO_SIDED|95.0|-1.8|4.9|||||Group 1 - Group 2|||4.9|-1.8|
73810713|NCT02880865|147170310|OTHER||Difference|0.3|||||TWO_SIDED|95.0|-0.3|1.0|||||Group 1 - Group 2|||1.0|-0.3|
73810714|NCT02880865|147170311|OTHER||Difference|4.1|||||TWO_SIDED|95.0|-3.1|11.3||||||||11.3|-3.1|
73810715|NCT02880865|147170312|OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|1.0|1.4|||||Group 1 / Group 2 ratio obtained using an analysis of covariance (ANCOVA) method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody titer.|||1.4|1.0|
73810716|NCT01056198|147170336|SUPERIORITY_OR_OTHER||||||=|0.208||95.0|||||ANCOVA|||The BWAT-m scores were compared at each of the 4 treatment weeks and at the end of the follow-up using a mixed-effects ANCOVA for the intent-to-treat population. Treatment and treatment week, as well as their interaction, were defined as fixed effects with subject as a random effect. The BWAT-m score at baseline was used as a covariate.||||=0.208
73810717|NCT01056198|147170337|SUPERIORITY_OR_OTHER||||||=|0.2737||95.0|||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.||||=0.2737
73810718|NCT01056198|147170338|SUPERIORITY_OR_OTHER||||||=|0.2741||95.0|||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.||||=0.2741
73810719|NCT01056198|147170339|SUPERIORITY_OR_OTHER||||||=|0.0164||95.0|||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05||||=0.0164
73810720|NCT01056198|147170340|SUPERIORITY_OR_OTHER||||||=|0.9392||95.0|||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05||||=0.9392
73896182|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.7045||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7045
73896183|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.7088||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7088
73896184|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.5828||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5828
73896185|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.0116||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0116
73896186|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.7848||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7848
73896187|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.0335||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0335
73896188|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.0591||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0591
73896189|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.9317||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.9317
73896190|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.0675||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0675
73896191|NCT00600119|147325818|SUPERIORITY_OR_OTHER|||||||0.1745||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1745
73896192|NCT03241368|147325819|OTHER|Comparative - This purpose of this study is to evaluate performance of the PillCam Crohn's capsule \[referred to as capsule endoscopy (CE)\] as compared to IC with MRE.||||||0.125|||||||McNemar|Exact McNemar's test||This was a 1-arm, non-powered study. Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) was estimated for each treatment group, along with the 95% confidence interval. The difference between treatment groups in Sensitivity and Specificity was compared.||||0.125
73896193|NCT01270802|147325849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.76||0.67|TWO_SIDED|95.0|-0.75|2.37||P-value was not adjusted for multiple comparisons; P\<0.05 was considered statistically significant.|t-test, 2 sided|||We assumed that the declines in FMD seen with TDF/FTC/EFV in our previous study would fully reverse. Thus, the clinically relevant effect size to be detected for FMD change was +3.12% (SD 4%) in those switching from EFV to RAL. Using a two-sample, independent, two-tailed t-test with 5% type I error and 20% type II error, a sample size of 13 per group would be needed to find a difference in FMD between groups. Allowing for a 10% dropout rate, we planned to recruit 15 subjects per group.||2.37|-0.75|0.67
73896194|NCT01270802|147325850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.63|STANDARD_ERROR_OF_MEAN|5.52||0.4|TWO_SIDED|95.0|-13.04|9.77||P-value was not adjusted for multiple comparisons. P\<0.05 was considered statistically significant.|t-test, 2 sided|||||9.77|-13.04|0.40
73896195|NCT00561977|147325864|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Mixed Models Analysis|time measurement, treatment group, interaction between time and group term as fixed effect, subject as random effect.||Mean dietary quality score by visit and study group was estimated using SAS PROC MIXED. All analyses were performed using SAS 9.13 (SAS Institute, Cary, NC, USA).||||0.14
73896196|NCT04620798|147325874|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.96|1.07|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.07|0.96|
73896197|NCT04620798|147325874|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.77|1.44|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.44|0.77|
73896198|NCT04620798|147325875|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.89|1.1|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.10|0.89|
73896199|NCT04620798|147325875|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.5|1.62|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.62|0.50|
73896200|NCT04620798|147325876|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.96|1.06|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.06|0.96|
73896201|NCT04620798|147325876|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.74|1.31|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.31|0.74|
73810721|NCT04017832|147170341|SUPERIORITY||Mean Difference (Net)|-0.2||||0.0078|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.1|-0.3|0.0078
73810722|NCT04017832|147170341|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.6||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.6|-0.8|<0.0001
73810723|NCT04017832|147170341|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.8|-1.1|< 0.0001
73810724|NCT02294175|147170387|SUPERIORITY|||||||0.029||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p\<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.029
73810725|NCT02294175|147170388|SUPERIORITY|||||||0.037||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p\<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.037
73810726|NCT02294175|147170389|SUPERIORITY|||||||0.012||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.012
73810727|NCT02294175|147170390|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||||||.397
73810728|NCT02294175|147170391|SUPERIORITY|||||||0.661||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in MMP-9 over time varies according to treatment arm.||||.661
73810729|NCT02294175|147170392|SUPERIORITY|||||||0.979||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in IL6 over time varies according to treatment arm.||||.979
73810730|NCT02294175|147170393|SUPERIORITY|||||||0.999|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.999
73810731|NCT02294175|147170394|SUPERIORITY|||||||0.415|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.415
73810732|NCT02294175|147170395|SUPERIORITY|||||||0.993|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.993
73810733|NCT02294175|147170396|SUPERIORITY|||||||0.99|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.990
73810734|NCT00792688|147170397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0062
73810735|NCT00792688|147170397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0331||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0331
73810736|NCT04464720|147170427|OTHER|||||||0.05|||||||Wilcoxon Ranked Sum|||comparing pre and post intervention PM2.5||||0.050
73810737|NCT04464720|147170430|OTHER|||||||0.043|||||||Wilcoxon Ranked Sum|||comparing pre v post intervention NO2||||0.043
73810738|NCT04464720|147170433|OTHER|||||||0.056|||||||Wilcoxon Ranked Sum|||comparing FVC pre and post intervention||||0.056
73810739|NCT04464720|147170434|OTHER|||||||0.058|||||||Wilcoxon Signed Rank|||Comparing FEV1 pre and post intervention||||0.058
73810740|NCT04464720|147170436|OTHER|||||||0.058|||||||Wilcoxon Ranked Sum|||comparing FeNO pre v post intervention||||0.058
73810741|NCT05537792|147170445|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.579|||||||t-test, 1 sided|||||||0.579
73810742|NCT05537792|147170445|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.0008|||||||t-test, 1 sided|||||||0.0008
73810743|NCT05537792|147170445|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.5513|||||||t-test, 1 sided|||||||0.5513
73810744|NCT05537792|147170445|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.00034|||||||t-test, 1 sided|||||||0.00034
73810745|NCT03495154|147170453|OTHER|This was not a comparative endpoint.|Percentage and confidence interval|3.3|||||TWO_SIDED|95.0|1.0|8.5||||||Number of participants with hernia recurrence within 12 months following Parietene™ DS Composite Mesh use in ventral hernia repair||8.5|1.0|
73810746|NCT03495154|147170454|OTHER|Statistical Analysis is based on number of participants with incidence of with ADEs at discharge. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|14.0|||||TWO_SIDED|||||||||||||
73810747|NCT03495154|147170454|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 1 month. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|31.0|||||TWO_SIDED|||||||||||||
73810748|NCT03495154|147170454|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 3 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|34.0|||||TWO_SIDED|||||||||||||
73810749|NCT03495154|147170454|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 12 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|40.0|||||TWO_SIDED|||||||||||||
73810750|NCT03495154|147170454|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 24 months. Adverse Device Effects (ADEs) are inclusive of both procedure and device related AEs.|Number of Subjects with ADEs|42.0|||||TWO_SIDED|||||||||||||
73810751|NCT03495154|147170455|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 1M|0.0|||||TWO_SIDED|95.0|0.0|2.9||||||||2.9|0|
73810752|NCT03495154|147170455|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 3M|0.0|||||TWO_SIDED|95.0|0.0|3.0||||||||3.0|0|
73810753|NCT03495154|147170455|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 24M|4.0|||||TWO_SIDED|95.0|1.2|9.6||||||||9.6|1.2|
73810754|NCT02100670|147170479|SUPERIORITY_OR_OTHER||Difference of LS mean|-9.23||||0.4144|TWO_SIDED|95.0|-31.45|12.98||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||12.98|-31.45|0.4144
73810755|NCT02100670|147170480|SUPERIORITY_OR_OTHER||LS mean difference|1.58||||0.8761|TWO_SIDED|95.0|-18.34|21.5||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||21.50|-18.34|0.8761
73810756|NCT02100670|147170480|SUPERIORITY_OR_OTHER||LS mean difference|2.61||||0.8164|TWO_SIDED|95.0|-19.46|24.67||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||24.67|-19.46|0.8164
73810757|NCT02100670|147170480|SUPERIORITY_OR_OTHER||LS mean difference|1.03||||0.9279|TWO_SIDED|95.0|-21.27|23.33||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||23.33|-21.27|0.9279
73810758|NCT02100670|147170480|SUPERIORITY_OR_OTHER||LS mean difference|-10.81||||0.3442|TWO_SIDED|95.0|-33.26|11.64||P-value from multiple comparisons using t-test in Proc Mixed.|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||11.64|-33.26|0.3442
73810759|NCT02100670|147170485|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.1||||0.5404|TWO_SIDED|95.0|0.81|1.48||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.48|0.81|0.5404
73810760|NCT02100670|147170485|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|0.9||||0.4639|TWO_SIDED|95.0|0.67|1.2||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.20|0.67|0.4639
73810761|NCT02100670|147170485|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.09||||0.5118|TWO_SIDED|95.0|0.84|1.43||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.43|0.84|0.5118
73810762|NCT02100670|147170486|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|0.93||||0.6918|TWO_SIDED|95.0|0.67|1.31||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.31|0.67|0.6918
73810763|NCT02100670|147170486|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.23||||0.2389|TWO_SIDED|95.0|0.87|1.73||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.73|0.87|0.2389
73810764|NCT02100670|147170486|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.0||||0.9817|TWO_SIDED|95.0|0.74|1.37||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.37|0.74|0.9817
73810765|NCT02100670|147170487|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.06||||0.7003|TWO_SIDED|95.0|0.79|1.43||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.43|0.79|0.7003
73810766|NCT02100670|147170487|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.01||||0.9565|TWO_SIDED|95.0|0.75|1.35||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.35|0.75|0.9565
73810767|NCT02100670|147170487|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.07||||0.6216|TWO_SIDED|95.0|0.82|1.4||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.40|0.82|0.6216
73810768|NCT02100670|147170491|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|2.43||||0.0408|TWO_SIDED|95.0|1.04|5.7||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||5.70|1.04|0.0408
73810769|NCT02100670|147170491|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.31||||0.4507|TWO_SIDED|95.0|0.65|2.65||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||2.65|0.65|0.4507
73810770|NCT02100670|147170491|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.38||||0.315|TWO_SIDED|95.0|0.73|2.61||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||2.61|0.73|0.3150
73810771|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.75|1.17|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 3||1.17|0.75|<0.001
73810772|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.88|1.33|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 7F||1.33|0.88|<0.001
73810773|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.12|||<|0.001|TWO_SIDED|95.0|0.93|1.36|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 8||1.36|0.93|<0.001
73810774|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.86|1.29|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 9N||1.29|0.86|<0.001
73810775|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.65|||<|0.001|TWO_SIDED|95.0|1.28|2.14|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 10A||2.14|1.28|<0.001
73810776|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.52|||<|0.001|TWO_SIDED|95.0|1.2|1.92|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 11A||1.92|1.20|<0.001
73896202|NCT04620798|147325877|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.84|1.09|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.09|0.84|
73810777|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.97|||<|0.001|TWO_SIDED|95.0|1.43|2.72|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 12F||2.72|1.43|<0.001
73810778|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.28|2.0|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 17F||2.00|1.28|<0.001
73810779|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.16|||<|0.001|TWO_SIDED|95.0|0.93|1.45|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 19A||1.45|0.93|<0.001
73810780|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.44|||<|0.001|TWO_SIDED|95.0|1.18|1.77|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 20A||1.77|1.18|<0.001
73810781|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.39|||<|0.001|TWO_SIDED|95.0|1.1|1.76|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 22F||1.76|1.10|<0.001
73810782|NCT05633992|147170499|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.68|1.12|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 33F||1.12|0.68|<0.001
73810783|NCT05633992|147170499|NON_INFERIORITY|For serotype 15B, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.43|||<|0.001|TWO_SIDED|95.0|1.07|1.89|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 15B||1.89|1.07|<0.001
73810784|NCT05633992|147170499|SUPERIORITY|For serotype 15C, a conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>1.0 (one-sided p-value \<0.025).|Day 30 GMT Ratio|2.05|||<|0.001|TWO_SIDED|95.0|1.56|2.7|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 15C||2.70|1.56|<0.001
73810785|NCT05633992|147170500|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|27.6|||<|0.001|TWO_SIDED|95.0|17.8|36.9|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 6A||36.9|17.8|<0.001
73810786|NCT05633992|147170500|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|33.7|||<|0.001|TWO_SIDED|95.0|23.6|43.0|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 15A||43.0|23.6|<0.001
73896203|NCT04620798|147325877|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.33|1.72|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.72|0.33|
73896204|NCT04620798|147325878|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.74|1.04|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.04|0.74|
73810787|NCT05633992|147170500|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|38.3|||<|0.001|TWO_SIDED|95.0|29.8|46.4|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 16F||46.4|29.8|<0.001
73810788|NCT05633992|147170500|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|29.5|||<|0.001|TWO_SIDED|95.0|17.4|40.6|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 23A||40.6|17.4|<0.001
73810789|NCT05633992|147170500|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|38.3|||<|0.001|TWO_SIDED|95.0|29.3|46.7|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 23B||46.7|29.3|<0.001
73810790|NCT05633992|147170500|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|27.1|||<|0.001|TWO_SIDED|95.0|18.3|35.6|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 24F||35.6|18.3|<0.001
73810791|NCT05633992|147170500|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|57.3|||<|0.001|TWO_SIDED|95.0|49.3|64.4|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 31||64.4|49.3|<0.001
73810792|NCT05633992|147170500|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|47.0|||<|0.001|TWO_SIDED|95.0|39.5|54.1|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 35B||54.1|39.5|<0.001
73810793|NCT03634033|147170507|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on adoption and sustainability using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|10.89|STANDARD_DEVIATION|18.17||0.22|TWO_SIDED|95.0|-7.27|29.05||A priori threshold for statistical significance was .05|t-test, 2 sided|16 degrees of freedom for the t-test comparing two independent groups, n=9 each.||Given 18 sites (9 in each arm) available in Michigan, in the comparison of site-level outcome of adoption and sustainability, the detectable effect size with power of 0.80 in two-sided tests at .05 level of significance was d=1.41.||29.05|-7.27|0.22
73810794|NCT03634033|147170508|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries ADLs at exit using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.23||0.73|TWO_SIDED|95.0|-0.16|0.73||A priori threshold for statistical significance was .05; no adjustments for multiple comparisons|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering via a random effect of site.|IF minus IF+EF|Adjusted means at month 9 were calculated adjusting for baseline value of the outcome and nesting of participants within sites.||0.73|-0.16|0.73
73810795|NCT03634033|147170509|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries IADLs using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.15|TWO_SIDED|95.0|-0.11|0.72||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering.|IF minus IF+EF|Post-intervention means were compared adjusting for baseline values and nesting of participants within sites.||0.72|-0.11|0.15
73896205|NCT04620798|147325878|SUPERIORITY||Risk Ratio (RR)|1.4|||||TWO_SIDED|95.0|0.6|3.25|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||3.25|0.60|
73896206|NCT04620798|147325879|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||"This analysis compares the probability of a response of Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.03|0.99|
73810796|NCT03634033|147170510|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries pain at exit using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.16||0.61|TWO_SIDED|95.0|-0.23|0.39||Threshold for statistical significance was.05; no adjustments for multiple comparisons|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering.|IF minus IF+EF|||0.39|-0.23|0.61
73810797|NCT03634033|147170511|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries depression (baseline to exit) using an evidence-based intervention (CAPABLE).|LS Means|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.04|TWO_SIDED|95.0|0.01|0.24|||F-test|F-test was used (related to the t-test arithmetically), built into mixed models that adjusted for clustering.||||0.24|0.01|0.04
73810798|NCT03634033|147170512|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries fall rates at exit after an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|1.16|STANDARD_ERROR_OF_MEAN|0.01||0.18|TWO_SIDED|95.0|0.93|1.45|||Mixed Models Analysis|||||1.45|0.93|0.18
73810799|NCT03634033|147170512|SUPERIORITY||Odds Ratio (OR)|1.16||||0.18|TWO_SIDED|95.0|0.93|1.45||Threshold for statistical significance was .05; no adjustment for multiple comparisons.|Mixed Models Analysis||Odds ratio for IF versus IF+EF|Occurrence of falls was analyzed with adjustment for baseline and nesting of participants within sites.||1.45|0.93|.18
73810800|NCT03634033|147170513|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries ED Visits at exit after an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.01||0.86|TWO_SIDED|95.0|0.79|1.22||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|Mixed Models Analysis|Adjustment for baseline and nesting of participants within sites.||||1.22|0.79|0.86
73810801|NCT03634033|147170514|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries hospitalizations (baseline to exit) using an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.01||0.95|TWO_SIDED|95.0|0.72|1.42|||F-test|F-test was used (related to the t-test arithmetically), built into mixed models that adjusted for clustering.||||1.42|0.72|0.95
73810802|NCT03634033|147170515|SUPERIORITY|Examination of clinician attitude on facilitation (IF vs IF+EF) at exit when using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|2.55||0.05|TWO_SIDED|95.0|0.09|10.14|||Mixed Models Analysis|||Mixed modeling was used to account for nesting of clinicians within sites.||10.14|0.09|0.05
73810803|NCT03634033|147170516|OTHER|Examination of clinician self-efficacy on facilitation (IF vs IF+EF) (baseline to exit) when using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.36||0.54|TWO_SIDED|95.0|-0.51|0.97||Threshold for statistical significance was .05 with no adjustments for multiple testing.|Mixed Models Analysis|Nesting of clinicians within site was adjusted for as a random effect.||||0.97|-0.51|0.54
73810804|NCT03634033|147170519|SUPERIORITY|Pre-/post-intervention comparison.|Mean Difference (Net)|-2.69|STANDARD_ERROR_OF_MEAN|1.63|<|0.01|TWO_SIDED|95.0|-3.96|-1.42|||t-test, 2 sided||Pre minus post|Pain||-1.42|-3.96|<.01
73810805|NCT03634033|147170519|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|1.9||0.58|TWO_SIDED|95.0|-2.8|4.91||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided|||ADL||4.91|-2.80|.58
73810806|NCT03634033|147170519|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|1.29||0.44|TWO_SIDED|95.0|-2.8|4.91||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided|||IADL||4.91|-2.80|.44
73810807|NCT03634033|147170519|SUPERIORITY||Mean Difference (Net)|1.46|STANDARD_ERROR_OF_MEAN|1.63||0.38|TWO_SIDED|95.0|-1.85|4.77||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided||Pre minus post|Depression||4.77|-1.85|.38
73810808|NCT03634033|147170520|SUPERIORITY|Self-efficacy|Mean Difference (Net)|-0.81|STANDARD_DEVIATION|0.11|<|0.01|TWO_SIDED|95.0|-1.02|-0.6||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided||Pre minus post|Self-efficacy change baseline (month-0) to exit (month-4).||-0.60|-1.02|<0.01
73896207|NCT04620798|147325879|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.77|1.21|||||"This analysis compares the probability of a response of Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.21|0.77|
73896208|NCT04620798|147325880|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.97|1.06|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.06|0.97|
73810809|NCT03634033|147170521|OTHER|Score on scale.|Mean|8.09|STANDARD_DEVIATION|1.6|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<.01
73810810|NCT03634033|147170521|OTHER||Mean|7.55|STANDARD_DEVIATION|2.06|<|0.01|TWO_SIDED||||||t-test, 2 sided|||Satisfaction with format||||<.01
73810811|NCT03634033|147170521|OTHER||Mean|8.35|STANDARD_DEVIATION|1.5|<|0.01|TWO_SIDED||||||Difference from zero|||Satisfaction with newness of content for caregiver||||<.01
73810812|NCT03634033|147170521|OTHER||Mean|7.85|STANDARD_DEVIATION|1.92|<|0.01|TWO_SIDED||||||Difference from zero|||Satisfaction with newness of content for clinician||||<.01
73810813|NCT03634033|147170521|OTHER||Mean|7.85|STANDARD_DEVIATION|1.92|<|0.01|TWO_SIDED||||||Difference from zero|||Intent to use new information||||<.01
73810814|NCT04338269|147170531|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.7844|TWO_SIDED|95.0|0.83|1.28|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.28|0.83|0.7844
73810815|NCT04338269|147170531|OTHER||Hazard Ratio (HR)|1.04||||0.7195|TWO_SIDED|95.0|0.84|1.29|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|Cox Proportional Hazards Model||1.29|0.84|0.7195
73810816|NCT04338269|147170532|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|0.94||||0.6902|TWO_SIDED|95.0|0.7|1.27|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.27|0.70|0.6902
73810817|NCT04338269|147170532|OTHER|Cox Proportional Hazards Model|Hazard Ratio (HR)|0.96||||0.7853||95.0|0.71|1.27|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|||1.27|0.71|0.7853
73810818|NCT04338269|147170533|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.8037|TWO_SIDED|95.0|0.83|1.27|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.27|0.83|0.8037
73810819|NCT04338269|147170533|OTHER|Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.7894|TWO_SIDED|95.0|0.83|1.27|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|||1.27|0.83|0.7894
73810820|NCT04338269|147170534|OTHER|Difference in Overall Response Rates|Odds Ratio (OR)|-3.68||||0.4306|TWO_SIDED|95.0|-12.45|5.1|||Cochran-Mantel-Haenszel||Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis|||5.10|-12.45|0.4306
73810821|NCT04338269|147170535|OTHER|Difference in Overall Response Rates|Odds Ratio (OR)|1.0||||0.9893|TWO_SIDED|95.0|0.7|1.43|||Cochran-Mantel-Haenszel||Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis|||1.43|0.70|0.9893
73810822|NCT04338269|147170536|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|0.7||||0.0816|TWO_SIDED|95.0|0.47|1.05|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.05|0.47|0.0816
73810823|NCT04338269|147170536|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|0.72||||0.1099||95.0|0.49|1.08|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.08|0.49|0.1099
73810824|NCT04338269|147170537|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|1.04||||0.8354|TWO_SIDED|95.0|0.7|1.54|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.54|0.70|0.8354
73810825|NCT04338269|147170537|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|1.05||||0.8159|TWO_SIDED|95.0|0.71|1.55|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.55|0.71|0.8159
73810826|NCT05129475|147170615|OTHER||Ratio of Adjusted Geometric Means|120.9|||||TWO_SIDED|90.0|109.3|133.74|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||133.74|109.30|
73810827|NCT05129475|147170616|OTHER||Ratio of Adjusted Geometric Means|119.67|||||TWO_SIDED|90.0|108.75|131.68|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||131.68|108.75|
73810828|NCT05129475|147170617|OTHER||Ratio of Adjusted Geometric Means|161.01|||||TWO_SIDED|90.0|139.05|186.44|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||186.44|139.05|
73810829|NCT00308087|147170626|SUPERIORITY_OR_OTHER|||||||0.6182||95.0||||"Exact Conditional Test is stratified on the number~\> of prior therapies (1 or 2, 3 or more prior therapies)."|2-sided Exact Conditional Test|||||||0.6182
73896209|NCT04620798|147325880|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.6|1.11|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.11|0.60|
73810830|NCT00308087|147170629|SUPERIORITY_OR_OTHER|||||||0.5501||95.0|||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.||||0.5501
73810831|NCT00308087|147170630|SUPERIORITY_OR_OTHER|||||||0.8217||95.0|||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.||||0.8217
73810832|NCT00380081|147170669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
73810833|NCT00380081|147170670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||<0.001
73810834|NCT00380081|147170671|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
73810835|NCT00380081|147170672|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
73810836|NCT00380081|147170673|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
73810837|NCT00380081|147170674|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
73810838|NCT00380081|147170675|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||The outcome noted above reflects the all-night sleep quality rating of study subjects who had a scheduled awakening after approximately 4 hours of sleep, were kept awake for 30 minutes and then allowed to return to bed and to sleep. After 4 hours, they were awakened again and disconnected from the PSG apparatus. Morning testing was conducted that included the Sleep Quality questionnaire. Evaluation of the results should reflect the nature of the study and the scheduled sleep disturbance.||||<0.001
73810839|NCT00380081|147170676|SUPERIORITY_OR_OTHER||||||<|0.004||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||<0.004
73810840|NCT00380081|147170677|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||0.012
73810841|NCT00380081|147170678|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
73810842|NCT00380081|147170679|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
73810843|NCT00380081|147170680|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||Treatment effect|ANCOVA|||||||0.790
73810844|NCT00380081|147170681|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||Treatment effect|ANCOVA|||||||0.083
73810845|NCT00380081|147170682|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||Treatment effect|ANCOVA|||||||0.072
73810846|NCT00380081|147170682|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Period effect|ANCOVA|||||||<0.001
73810847|NCT00380081|147170683|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||Treatment effect|ANCOVA|||||||0.017
73810848|NCT05007041|147170684|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-0.96||||0.0037|TWO_SIDED|95.0|-8.94|7.1|||Difference in proportions|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.||The null hypothesis is simultaneous vaccination with RZV and allV4 is inferior (i.e., RZV and allV4 will have a higher proportion) to RZV and HD-IIV4 with regard to the proportion of adults with at least one severe (Grade 3) solicited local or systemic reactogenicity event on days 1-8 after RZV dose||7.10|-8.94|0.0037
73810849|NCT05007041|147170685|OTHER|Difference in proportions|Difference in proportions|-7.77|||||TWO_SIDED|95.0|-20.22|4.69||||||||4.69|-20.22|
73810850|NCT05007041|147170686|OTHER|Difference in proportions|Difference in proportions|2.59|||||TWO_SIDED|95.0|-7.29|12.47||||||||12.47|-7.29|
73810851|NCT05007041|147170687|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|1.74||||0.0031|TWO_SIDED|95.0|-4.04|7.77||The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Difference in proportions|||Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After SHINGRIX® Dose 1 in Each Study Group||7.77|-4.04|0.0031
73810852|NCT05007041|147170688|OTHER|Difference in proportions|Difference in proportions|-6.25|||||TWO_SIDED|95.0|-13.1|0.6|||Difference in proportions|||||0.60|-13.10|
73810853|NCT05007041|147170689|OTHER|Difference in proportions|Difference in proportions|5.89|||||TWO_SIDED|95.0|-1.32|13.11|||Difference in proportions|||||13.11|-1.32|
73810854|NCT05007041|147170690|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-4.17|||<|0.0001|TWO_SIDED|95.0|-10.9|2.47|||Difference in proportions|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.||||2.47|-10.90|<0.0001
73810855|NCT05007041|147170691|OTHER|Difference in proportions|Difference in proportions|-5.68|||||TWO_SIDED|95.0|-17.64|6.28|||Difference in proportions|||||6.28|-17.64|
73896210|NCT04620798|147325881|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.04|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.04|0.97|
73896211|NCT04620798|147325881|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.74|1.12|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.12|0.74|
73810856|NCT05007041|147170692|OTHER|Difference in proportions|Difference in proportions|-3.3|||||TWO_SIDED|95.0|-10.5|3.89|||Difference in proportions|||||3.89|-10.50|
73810857|NCT05007041|147170693|OTHER|Difference in proportions|Difference in proportions|-0.73|||||TWO_SIDED|95.0|-2.16|0.7|||Difference in proportions|||||0.70|-2.16|
73810858|NCT05007041|147170694|OTHER|The proportion and 95% exact binomial confidence interval between vaccine groups.|Difference in proportions|-2.88|||||TWO_SIDED|95.0|-6.36|0.6|||Difference in proportions|||||0.60|-6.36|
73810859|NCT01500213|147170771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.043|TWO_SIDED|95.0|1.0|2.1||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.1|1.0|0.043
73810860|NCT01500213|147170772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.233|TWO_SIDED|95.0|0.8|2.0||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|0.8|0.233
73810861|NCT01500213|147170773|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.084|TWO_SIDED|95.0|1.0|1.9||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||1.9|1.0|0.084
73810862|NCT00985959|147170780|SUPERIORITY_OR_OTHER||Overall response rate (%)|69.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|95.0|58.9|79.2||Significance level 5% one-tailed. Threshold response rate 35%|Binominal test|||||79.2|58.9|<0.0001
73810863|NCT01777568|147170795|SUPERIORITY||Risk Ratio (RR)|0.99||||0.85|TWO_SIDED|95.0|0.85|1.14|||GEE model||Relative Risk: 80% (numerator) vs. 30% (denominator)|||1.14|0.85|0.85
73810864|NCT01777568|147170796|SUPERIORITY||Risk Ratio (RR)|0.8||||0.047|TWO_SIDED|95.0|0.66|1.01|||Chi-squared|||||1.01|0.66|0.047
73810865|NCT00844480|147170797|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
73810866|NCT02858180|147170800|OTHER||Proportion|86.7|||||TWO_SIDED|95.0|59.5|98.3||||||||98.3|59.5|
73810867|NCT00574249|147170822|SUPERIORITY_OR_OTHER|||||||0.086||||||Level of significance 5%; no adjustment for multiple comparisons necessary.|Cochran-Mantel-Haenszel|Two-sided CMH test stratified by country at the alpha level 0.05. Centers were pooled by country (Sweden and Finland pooled due to few participants).||Comparison of the proportion of participants in the adalimumab + calcipotriol/betamethasone group vs. the adalimumab + placebo group.||||0.086
73810868|NCT00574249|147170823|SUPERIORITY_OR_OTHER|||||||0.565||95.0|||||Fisher Exact|||||||0.565
73810869|NCT00574249|147170824|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||||||0.002
73810870|NCT00574249|147170825|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
73810871|NCT00574249|147170826|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|||||||0.004
73810872|NCT00574249|147170827|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Fisher Exact|||||||0.011
73810873|NCT00574249|147170828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74||||0.204||95.0|-5.3|24.78|||ANOVA|One-way ANOVA. For confidence interval and difference estimate, adalimumab + calcipotriol/betamethasone minus adalimumab + placebo was used.||||24.78|-5.30|0.204
73810874|NCT00574249|147170829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.55||||0.272||95.0|-48.92|13.82|||ANOVA|One-way ANOVA. Confidence interval and difference estimated from adalimumab + calcipotriol/betamethasone minus adalimumab + placebo.||||13.82|-48.92|0.272
73810875|NCT00574249|147170830|SUPERIORITY_OR_OTHER|||||||0.413||95.0|||||Fisher Exact|||||||0.413
73810876|NCT00574249|147170831|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73810877|NCT00574249|147170832|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Fisher Exact|||||||0.028
73810878|NCT00574249|147170833|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||ANOVA|One-way ANOVA.||||||0.228
73810879|NCT00574249|147170834|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|One-way ANOVA.||||||< 0.001
73810880|NCT00574249|147170835|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|One-way ANOVA.||||||0.001
73810881|NCT00574249|147170836|SUPERIORITY_OR_OTHER|||||||0.764||95.0|||||ANOVA|One-way ANOVA.||||||0.764
73810882|NCT00574249|147170837|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||ANOVA|One-way ANOVA.||||||0.437
73810883|NCT00574249|147170838|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANOVA|One-way ANOVA.||||||0.740
73810884|NCT00574249|147170839|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||ANOVA|One-way ANOVA.||||||0.634
73810885|NCT00347919|147170842|SUPERIORITY_OR_OTHER||Percentage difference|2.7||||0.3724||90.0|-11.0|16.3|||Chi-squared||Difference in the percentage of independently-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)|||16.3|-11.0|0.3724
73810886|NCT00347919|147170842|SUPERIORITY_OR_OTHER||Percentage difference|5.4||||0.2578||90.0|-8.4|19.2|||Chi-squared||Difference in the percentage of investigator-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)|||19.2|-8.4|0.2578
73810887|NCT00347919|147170843|SUPERIORITY_OR_OTHER|||||||0.7488||95.0|||||Log Rank|||||||0.7488
73810888|NCT02548351|147170883|OTHER||Hazard Ratio (HR)|0.814||||0.1028|TWO_SIDED|95.0|0.635|1.043|||Log Rank|||||1.043|0.635|0.1028
73810889|NCT02548351|147170883|OTHER||Hazard Ratio (HR)|0.772||||0.0444|TWO_SIDED|95.0|0.6|0.994|||Log Rank|||||0.994|0.600|0.0444
73810890|NCT02548351|147170884|OTHER||Difference in percentages|7.1|||<|0.0001|TWO_SIDED|95.0|3.6|10.6|||Cochran-Mantel-Haenszel|||||10.6|3.6|<0.0001
73810891|NCT02548351|147170884|OTHER||Treatment difference|9.4|||<|0.0001|TWO_SIDED|95.0|5.8|13.0|||Cochran-Mantel-Haenszel|||||13.0|5.8|<0.0001
73810892|NCT02548351|147170885|OTHER||Treatment difference|6.7||||0.0004|TWO_SIDED|95.0|3.0|10.4|||Cochran-Mantel-Haenszel|||||10.4|3.0|0.0004
73810893|NCT02548351|147170885|OTHER||Treatment difference|9.0|||<|0.0001|TWO_SIDED|95.0|5.2|12.8|||Cochran-Mantel-Haenszel|||||12.8|5.2|<0.0001
73810894|NCT00125242|147170887|SUPERIORITY_OR_OTHER||effect size|7.15|STANDARD_DEVIATION|3.1|||TWO_SIDED||||||||the reported effect size is a d-index value|Effect sizes were calculated - this is a comparison of perfomance in baseline (repeated measurements prior to treatment) relative to peformance following treatment||||
73810895|NCT00606554|147170888|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
73810896|NCT00606554|147170892|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
73810897|NCT00606554|147170895|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
73810898|NCT05238025|147170916|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|42.9|||||TWO_SIDED|95.0|-16.1|71.9||||||||71.9|-16.1|
73810899|NCT05238025|147170917|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the first primary outcome is met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|59.0|||||TWO_SIDED|95.0|34.7|74.3|||||Not formally tested, since the first primary outcome was not met|||74.3|34.7|
73810900|NCT05238025|147170918|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if both primary outcomes are met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|48.8|||||TWO_SIDED|95.0|25.8|64.7|||||Not formally tested, since the first primary outcome was not met|||64.7|25.8|
73810901|NCT04545567|147170936|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73810902|NCT04545567|147170937|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
73810903|NCT04545567|147170938|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
73810904|NCT04545567|147170939|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73810905|NCT04545567|147170940|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
73810906|NCT04545567|147170941|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
73810907|NCT04545567|147170942|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
73810908|NCT04545567|147170943|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73810909|NCT04545567|147170944|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
73810910|NCT04545567|147170945|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
73810911|NCT04545567|147170946|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73810912|NCT04545567|147170947|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
73810913|NCT04545567|147170948|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
73810914|NCT04545567|147170949|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.05|TWO_SIDED||||||t-test, 1 sided|||||||0.05
73810915|NCT04545567|147170950|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
73810916|NCT04545567|147170951|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
73810917|NCT04545567|147170952|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
73810918|NCT04545567|147170953|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73810919|NCT04545567|147170954|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
73810920|NCT04545567|147170955|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
73810921|NCT02754674|147170956|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
73810922|NCT02754674|147170957|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
73810923|NCT02754674|147170958|SUPERIORITY|Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. The statistical significance level was set at .05.|||||>|0.05|||||||t-test, 2 sided|||We used the Kolmogorov-Smirnov test to assess the normality of the data distribution. Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. Pearson's Chi-square test or Fisher's exact test was used to analyze categorical variables between groups. The statistical significance level was set at .05.||||>0.05
73810924|NCT02754674|147170959|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73810925|NCT02754674|147170960|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||0.054
73810926|NCT02135107|147170969|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.||||||<0.001
73810927|NCT02135107|147170970|SUPERIORITY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at a two-sided significance level of alpha = 0.05.||Comparison at Week 12||||<0.001
73810928|NCT02135107|147170970|SUPERIORITY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.||Comparison at Week 24||||<0.001
73810929|NCT02135107|147170971|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.23|0.49|||Log Rank|||||0.49|0.23|<0.001
73810930|NCT02135107|147170972|SUPERIORITY||Group difference|-15.2|||<|0.001|TWO_SIDED|95.0|-23.5|-6.8|||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.|||-6.8|-23.5|<0.001
73810931|NCT02135107|147170975|SUPERIORITY||Group difference|0.0|||=|0.992|TWO_SIDED|95.0|-3.5|3.5||P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Chi-squared||Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.|||3.5|-3.5|=0.992
73810932|NCT03197324|147170978|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|100.4|||||TWO_SIDED|90.0|86.49|116.56|||||Digoxin group is the denominator and Digoxin with Bexagliflozin is the numerator. Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subjects as a random effect.|Geometric LS Mean was used as PK parameters||116.56|86.49|
73810933|NCT03197324|147170981|SUPERIORITY|Compare if co-administration of digoxin with bexagliflozin had significant impact on the PK of digoxin|Ratio of Geometric LSM|106.12|||||TWO_SIDED|90.0|95.82|117.53|||||Digoxin group is the denominator and Digoxin with Bexagliflozin is the numerator. Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subjects as a random effect.|Geometric LS Mean was used as PK parameters||117.53|95.82|
73810934|NCT02156895|147171000|OTHER||Odds Ratio (OR)|1.1||||0.1244|TWO_SIDED|95.0|0.97|1.24|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Inlyta as factor||||1.24|0.97|0.1244
73810935|NCT02156895|147171006|OTHER||Odds Ratio (OR)|1.11||||0.0109|TWO_SIDED|95.0|1.02|1.2|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Inlyta as factor||||1.2|1.02|0.0109
73810936|NCT03055494|147171015|OTHER|Statistical hypothesis tests were not performed in this study|difference in percentages|76.1|||||TWO_SIDED|95.0|63.3|88.8|||95% confidence interval|"Statistical analysis of no response of skin histology/K16 expression to treatment at Week 12"|||"A patient with missing assessment was considered as having a yes response of skin histology/K16 expression to treatment regardless of the reason for missing data (eg, premature study discontinuation, missed visit, administrative issues). However, missing baseline value was not imputed."|88.8|63.3|
73810937|NCT03055494|147171016|OTHER|Statistical hypothesis tests were not performed in this study|difference in percentages|55.8|||||TWO_SIDED|95.0|42.3|69.3|||95% confidence interval|||||69.3|42.3|
73810938|NCT04166591|147171031|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||binomial test|||||||<0.01
73810939|NCT04166591|147171031|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
73810940|NCT04166591|147171031|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
73810941|NCT04166591|147171031|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
73810942|NCT04166591|147171032|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
73810943|NCT04166591|147171032|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.||||||0.12|||||||Binomial test|||||||0.12
73810944|NCT04166591|147171032|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
73810945|NCT04166591|147171032|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
73810946|NCT02111746|147171033|SUPERIORITY|||||||0.934|||||||Wilcoxon (Mann-Whitney)|||||||0.934
73896212|NCT04620798|147325882|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.52|1.71|||||This analysis compares the probability of seroconverting during the study period. The reference group for this analysis was the control (delayed results) group.|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and seroconversion. The reference group for this analysis was the control (delayed results) group.||1.71|0.52|
73896213|NCT01616693|147325887|SUPERIORITY||Difference in seroconversion proportion|4.4|||||TWO_SIDED|97.5|-4.4|13.2||||||||13.2|-4.4|
73896214|NCT01616693|147325887|SUPERIORITY||Difference in seroconversion proportion|7.5|||||TWO_SIDED|95.0|-1.4|16.2||||||||16.2|-1.4|
73896215|NCT01616693|147325887|SUPERIORITY||Difference in seroconversion proportion|12.0|||||TWO_SIDED|95.0|0.8|22.8||||||||22.8|.8|
73810947|NCT02111746|147171034|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
73810948|NCT02111746|147171035|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
73810949|NCT02111746|147171036|SUPERIORITY|||||||0.512|||||||Wilcoxon (Mann-Whitney)|||||||0.512
73810950|NCT02111746|147171037|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
73810951|NCT02111746|147171038|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
73810952|NCT02111746|147171039|SUPERIORITY|||||||0.774|||||||Wilcoxon (Mann-Whitney)|||||||0.774
73810953|NCT02111746|147171040|SUPERIORITY|||||||0.188|||||||Wilcoxon (Mann-Whitney)|||||||0.188
73810954|NCT02111746|147171041|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
73810955|NCT00135798|147171079|SUPERIORITY_OR_OTHER|||||||0.0477||95.0||||One-sided test|Fisher Exact|||ITT analysis of pTVR: 0/13 Standard care vs. 11/46 Combined LADR-treated groups||||0.0477
73810956|NCT00135798|147171079|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Chi-squared|||ITT analysis of LADR-treated: 5/24 Genotypes 1,4,6 vs 6/22 Genotypes 2,3||||0.6090
73810957|NCT00135798|147171080|SUPERIORITY_OR_OTHER|||||||0.2014||95.0||||One-sided test|Fisher Exact|||ITT analysis of CVR: 1/16 Standard care vs. 12/63 Combined LADR-treated groups||||0.2014
73810958|NCT00135798|147171080|SUPERIORITY_OR_OTHER|||||||0.9513||95.0|||||Chi-squared|||ITT analysis of LADR-treated: 6/31 Genotypes 1,4,6 vs 6/32 Genotypes 2,3||||0.9513
73810959|NCT00135798|147171081|SUPERIORITY_OR_OTHER|||||||0.0274||95.0||||One-sided test|Fisher Exact|||PP analysis of pTVR: 0/13 Standard care vs. 11/44 Combined LADR-treated groups||||0.0274
73810960|NCT00135798|147171081|SUPERIORITY_OR_OTHER|||||||0.6011||95.0|||||Chi-squared|||PP analysis of LADR-treated: 5/23 G1,4,6 vs 6/21 G2,3||||0.6011
73810961|NCT00135798|147171082|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||One-sided test|Fisher Exact|||PP analysis of CVR: 0/20 Standard care vs. 13/59 Combined LADR-treated groups||||0.0153
73810962|NCT00135798|147171082|SUPERIORITY_OR_OTHER|||||||0.8065||95.0|||||Chi-squared|||PP analysis of LADR-treated: 7/30 G1,4,6 vs 6/29 G2,3||||0.8065
73810963|NCT04186806|147171083|NON_INFERIORITY|Non-inferiority margin was 1.5 cm|Mean Difference (Final Values)|-0.3426|||||TWO_SIDED|95.0|-1.2601|0.5749||The conclusion of the non-inferiority test is based on the 95% confidence interval and not on a p value. A p value was not computed.|Mixed Models Analysis||Non-inferiority testing was carried out using 95% confidence intervals.|||0.5749|-1.2601|
73810964|NCT00614120|147171155|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.8mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|-0.06|||<|0.0001||95.0|-0.23|0.11||Non-inferiority; \<.0001. In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.11|-0.23|<0.0001
73896216|NCT01616693|147325889|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-4.3|6.6||||||||6.6|-4.3|
73896217|NCT01616693|147325889|SUPERIORITY||Mean Difference (Net)|-3.1|||||TWO_SIDED|95.0|-8.6|2.3||||||||2.3|-8.6|
73896218|NCT01616693|147325889|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-9.8|5.7||||||||5.7|-9.8|
73896219|NCT02395172|147325895|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.0721|TWO_SIDED|95.0|0.71|1.05|||Log Rank|||||1.05|0.71|= 0.0721
73896220|NCT02395172|147325896|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.77|1.05||||||||1.05|0.77|
73896221|NCT02395172|147325897|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.8|1.27||||||||1.27|0.80|
73896222|NCT02395172|147325898|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.98|1.41||||||||1.41|0.98|
73896223|NCT02395172|147325901|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.92|2.13||||||||2.13|0.92|
73896224|NCT02395172|147325902|SUPERIORITY||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|1.08|2.86||||||||2.86|1.08|
73896225|NCT01134705|147325928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.84|||<|0.001|TWO_SIDED|95.0|-1.2|-0.5||A priori threshold for statistical significance is p\<0.05|Repeated measures Analysis of covariance|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.2|<0.001
73896226|NCT01134705|147325929|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.78|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||A priori threshold for statistical significance is p\<0.05|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
73896227|NCT01134705|147325930|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.001|TWO_SIDED|95.0|-0.9|-0.2||A priori threshold for statistical significance is p\<0.05|ANCOVA|ANCOVA with treatment, baseline and center in the model.||||-0.2|-0.9|0.001
73896228|NCT03512457|147325937|SUPERIORITY|Chi-square||||||0.12||||||P-value of \<0.05 is the threshold for statistical significance. The hypothesis was that more women randomized to the intensive intervention would perform skin self-examination.|Chi-squared|Chi-Squared is equal to 1.58, with a P-Value of 0.12.||change from baseline to 3 months in performance of skin self-examination Parallel: response rate||||0.12
73896229|NCT03512457|147325938|SUPERIORITY|Types of lesions in the following categories: Benign nevus, seborrheic keratosis, lentigo, dermatofibroma, atypical nevus. melanoma|||||<|0.05|||||||Chi-squared|||results of skin clinical examination and biopsy of clinically suspicious moles||||<0.05
73896230|NCT02390791|147325939|SUPERIORITY|||||||0.04|||||||generalized linear model|assuming a Poisson distribution with a log link function||||||0.04
73896231|NCT02390791|147325940|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
73896232|NCT02390791|147325941|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
73896233|NCT02390791|147325942|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
73896234|NCT02390791|147325943|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
73810965|NCT00614120|147171155|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.2mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.03|||<|0.0001||95.0|-0.14|0.2||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.20|-0.14|<.0001
73810966|NCT00614120|147171155|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 0.6mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.25||||0.0421||95.0|0.08|0.42||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.42|0.08|0.0421
73810967|NCT03687372|147171167|SUPERIORITY||Mean Difference (Final Values)|3.22||||0.0003|TWO_SIDED|95.0|1.67|6.22||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mixed Models Analysis|||A summary of the wart clearance at Visit 10.||6.22|1.67|0.0003
73896235|NCT02390791|147325944|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
73896236|NCT02390791|147325945|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
73896237|NCT02390791|147325946|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
73896238|NCT02390791|147325947|SUPERIORITY|||||||0.48|||||||generalized linear model|||||||0.48
73896239|NCT02390791|147325948|SUPERIORITY|||||||0.71|||||||generalized linear model|||||||0.71
73896240|NCT01375075|147325949|SUPERIORITY_OR_OTHER||LS Mean Difference|92.61|STANDARD_ERROR_OF_MEAN|9.04|<|0.001|TWO_SIDED|90.0|77.65|107.57||The P-value is for percent change from baseline in HDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||107.57|77.65|<0.001
73896241|NCT01375075|147325949|SUPERIORITY_OR_OTHER||LS Mean Difference|106.17|STANDARD_ERROR_OF_MEAN|10.69|<|0.001|TWO_SIDED|90.0|88.47|123.87||The P-value is for percent change from baseline in HDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||123.87|88.47|<0.001
73896242|NCT01375075|147325949|SUPERIORITY_OR_OTHER||LS Mean Difference|103.66|STANDARD_ERROR_OF_MEAN|11.18|<|0.001|TWO_SIDED|90.0|85.14|122.17||The P-value is for percent change from baseline in HDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||122.17|85.14|<0.001
73896243|NCT01375075|147325949|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.46|STANDARD_ERROR_OF_MEAN|4.39|<|0.001|TWO_SIDED|90.0|-24.73|-10.19||The P-value is for percent change from baseline in LDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-10.19|-24.73|<0.001
73896244|NCT01375075|147325949|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.39|STANDARD_ERROR_OF_MEAN|4.4||0.019|TWO_SIDED|90.0|-17.67|-3.11||The P-value is for percent change from baseline in LDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-3.11|-17.67|0.019
73810968|NCT03687372|147171168|SUPERIORITY|P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mean Difference (Final Values)|2.14||||0.0024|TWO_SIDED|95.0|1.3|3.52|||Mixed Models Analysis|||||3.52|1.30|0.0024
73810969|NCT03687372|147171169|SUPERIORITY||Odds Ratio (OR)|14.12|||<|0.0001|TWO_SIDED|95.0|7.5|20.8|||Wilcoxon (Mann-Whitney)|||||20.8|7.5|<0.0001
73810970|NCT03687372|147171170|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0009|TWO_SIDED|95.0|1.55|6.65|||Wilcoxon (Mann-Whitney)|||||6.65|1.55|0.0009
73810971|NCT03687372|147171171|SUPERIORITY||Hazard Ratio (HR)|2.56|||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
73810972|NCT04789291|147171178|OTHER||Ratios of adjusted geometric means [%]|102.76|||||TWO_SIDED|90.0|99.34|106.29|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 4.8.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||106.29|99.34|
73810973|NCT04789291|147171179|OTHER||Ratios of adjusted geometric means [%]|77.81|||||TWO_SIDED|90.0|69.77|86.76|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 15.5.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||86.76|69.77|
73810974|NCT04789291|147171180|OTHER||Ratios of adjusted geometric means [%]|103.24|||||TWO_SIDED|90.0|99.73|106.89|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 4.9.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||106.89|99.73|
73810975|NCT00805870|147171184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.271|STANDARD_ERROR_OF_MEAN|26.298|>|0.05|TWO_SIDED|95.0|-63.521|46.978|||ANOVA|||Null hypothesis is that no difference is observed in quadriceps muscle strength between the fish oil and control groups.||46.978|-63.521|>0.05
73810976|NCT00805870|147171185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.845|STANDARD_ERROR_OF_MEAN|1.417|>|0.05|TWO_SIDED|95.0|-4.823|1.132|||ANOVA|||Null hypothesis is that there is no difference in the amount of force applied to the quadriceps to elicit pain or discomfort between the fish oil and control groups.||1.132|-4.823|>0.05
73810977|NCT00805870|147171186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.015|STANDARD_ERROR_OF_MEAN|47.093|>|0.05|TWO_SIDED|95.0|-156.373|42.344|||ANOVA|||Null hypothesis is that there is no difference in creatine kinase activity between the fish oil and the control groups.||42.344|-156.373|>0.05
73896245|NCT01375075|147325949|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.26|STANDARD_ERROR_OF_MEAN|4.77||0.011|TWO_SIDED|90.0|-20.17|-4.36||The P-value is for percent change from baseline in LDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-4.36|-20.17|0.011
73810978|NCT00805870|147171187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.022|STANDARD_ERROR_OF_MEAN|0.188|>|0.05|TWO_SIDED|95.0|-0.374|0.417|||ANOVA|||The null hypothesis is that there is no difference in interleukin-6 concentration between the fish oil and control groups.||0.417|-0.374|>0.05
73810979|NCT01041976|147171229|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73810980|NCT01041976|147171230|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73810981|NCT00767039|147171254|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).|t-test, 2 sided|||Respiratory support were compared using a t-test for individual time points and Generalized Linear Model to account for correlations among repeated measures. Patient who survive \>/= 3 days were included in the analysis.||||< 0.05
73810982|NCT00767039|147171255|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.43|||<|0.05|TWO_SIDED|95.0|0.19|0.95|||Mantel Haenszel|||||0.95|0.19|<0.05
73810983|NCT00767039|147171256|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
73810984|NCT00767039|147171257|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|||<|0.05|TWO_SIDED|95.0|0.25|0.96|||Mantel Haenszel|||||0.96|0.25|<0.05
73810985|NCT00767039|147171258|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.38|||<|0.01|TWO_SIDED|95.0|1.29|4.38|||Mantel Haenszel|||||4.38|1.29|<0.01
73810986|NCT00767039|147171259|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
73810987|NCT00767039|147171260|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
73810988|NCT00767039|147171261|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
73810989|NCT00767039|147171262|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
73810990|NCT00767039|147171263|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.44|||>|0.05|TWO_SIDED|95.0|0.71|2.89|||Mantel Haenszel|||||2.89|0.71|>0.05
73810991|NCT00767039|147171264|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||>|0.05|TWO_SIDED|90.0|0.84|2.63|||Mantel Haenszel|||||2.63|0.84|>0.05
73810992|NCT01472757|147171280|SUPERIORITY|||||||0.013|||||||ANCOVA|||||||0.013
73810993|NCT01472757|147171280|SUPERIORITY||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA|||||||<0.001
73810994|NCT01472757|147171280|SUPERIORITY||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA|||||||<0.001
73810995|NCT01472757|147171281|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
73810996|NCT01472757|147171281|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
73810997|NCT01472757|147171281|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
73810998|NCT01472757|147171282|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
73810999|NCT01472757|147171282|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
73811000|NCT01472757|147171282|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
73811001|NCT02961062|147171306|SUPERIORITY||Mean Difference (Final Values)|-11.1|STANDARD_ERROR_OF_MEAN|0.0||0.005|TWO_SIDED|90.0|-17.54|-4.71|||Kenward-Roger method|||||-4.71|-17.54|0.005
73811002|NCT02961062|147171307|SUPERIORITY||Median Difference (Final Values)|-8.56|STANDARD_ERROR_OF_MEAN|3.37||0.017|TWO_SIDED|90.0|-14.29|-2.83|||Kenward-Roger method|||||-2.83|-14.29|0.017
73811003|NCT00478699|147171330|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.73|TWO_SIDED|95.0|0.689|1.298|||Log Rank|||Based on the relevant clinical evidence of the prognostic and predictive value of BRCA1, proposes the present study with which it is intended to demonstrate that adjuvant chemotherapy Individualized based on BRCA1 expression (Experimental arm), it is more effective than chemotherapy without individualize based (Control arm) in patients with completely resected stage II-IIIA NSCLC.||1.298|0.689|0.73
73811004|NCT00478699|147171331|SUPERIORITY||Median Difference (Final Values)|79.3||||0.753|TWO_SIDED|95.0|63.5|95.1|||Log Rank|||Control Arm v Experimental Arm||95.1|63.5|0.753
73811005|NCT00478699|147171331|SUPERIORITY|The initial hyphotesis were the disease free survival were longest under 65 vs upper 65.|Median Difference (Final Values)|38.7||||0.025|TWO_SIDED|95.0|28.0|38.7|||Log Rank|||Control Arm v Experimental Arm||38.7|28|0.025
73811006|NCT01005888|147171333|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Observed number of attacks.|ANOVA|||||||<0.0001
73811007|NCT01005888|147171333|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Normalized number of attacks.|ANOVA|||||||<0.0001
73896246|NCT01375075|147325952|SUPERIORITY_OR_OTHER||LS Mean Difference|3.74|STANDARD_ERROR_OF_MEAN|2.5||0.136|TWO_SIDED|90.0|-0.39|7.88||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||7.88|-0.39|0.136
73811008|NCT01005888|147171334|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||Period 1.|Fisher Exact|||||||>0.999
73811009|NCT01005888|147171334|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||Period 2.|Fisher Exact|||||||>0.999
73811010|NCT01005888|147171335|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0008
73811011|NCT01005888|147171336|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
73811012|NCT01005888|147171337|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73811013|NCT01005888|147171338|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73811014|NCT01005888|147171339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Visit 1 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73811015|NCT01005888|147171339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 4 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73811016|NCT01005888|147171339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0||||Week 8 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0001
73811017|NCT01005888|147171339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0||||Week 12 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0028
73811018|NCT01005888|147171340|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Visit 1 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73811019|NCT01005888|147171340|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 4 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73811020|NCT01005888|147171340|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 8 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73811021|NCT01005888|147171340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||Week 12 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0002
73811022|NCT01043705|147171341|SUPERIORITY_OR_OTHER||One sided Fisher's exact test.|0.0044||||0.0023|ONE_SIDED|95.0||0.009|||Fisher Exact|||||0.009||0.0023
73811023|NCT01043705|147171341|SUPERIORITY_OR_OTHER||1-sided Fisher's Exact Text|0.002||||0.0052|ONE_SIDED|95.0||0.01|||Fisher Exact|||||0.01||0.0052
73811024|NCT01043705|147171341|SUPERIORITY_OR_OTHER||1-sided Fisher's Exact Test|0.006||||0.0176|ONE_SIDED|95.0||0.014|||Fisher Exact|||||0.014||0.0176
73811025|NCT01043705|147171341|SUPERIORITY_OR_OTHER||Fisher's Exact Test|0.7||||0.3764|TWO_SIDED|95.0|||||Fisher Exact|||||||0.3764
73811026|NCT01043705|147171342|SUPERIORITY_OR_OTHER||Rate compared to performance goal|4.4||||0.0005|TWO_SIDED|95.0|3.3|5.8|||1-sided Chi-square|||||5.8|3.3|0.0005
73811027|NCT01043705|147171342|SUPERIORITY_OR_OTHER||Rate compared to a performance goal|3.1||||0.0444|TWO_SIDED|95.0|1.7|5.1|||1-sided Chi-square test|||||5.1|1.7|0.0444
73811028|NCT01043705|147171342|SUPERIORITY_OR_OTHER||rate compared to performance goal|5.4||||0.0006|TWO_SIDED|95.0|3.8|5.4|||1-sided Chi-squared test|||All types of mechanical complications combined.||5.4|3.8|0.0006
73811029|NCT01043705|147171342|SUPERIORITY_OR_OTHER||Descriptive|5.4||||0.0745|TWO_SIDED|95.0|3.7|7.5|||Chi-squared|||All mechanical complications, retrospective, non-TYRX cohort||7.5|3.7|0.0745
73811030|NCT04601103|147171350|OTHER|Generalized Fisher's Exact Test was used to detect an association between the 3 treatment groups and the incidence of sloughing||||||0.916|||||||Fisher Exact|||||||.916
73811031|NCT04713592|147171404|SUPERIORITY||Rate Difference|17.2|||=|0.006|TWO_SIDED|95.0|5.0|29.3||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||29.3|5.0|=0.006
73811032|NCT04713592|147171406|SUPERIORITY||Rate Difference|27.6|||<|0.001|TWO_SIDED|95.0|15.4|39.7||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||39.7|15.4|<0.001
73896247|NCT01375075|147325952|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|2.48||0.257|TWO_SIDED|90.0|-1.28|6.94||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||6.94|-1.28|0.257
73811033|NCT04713592|147171407|SUPERIORITY||Rate Difference|21.8|||<|0.001|TWO_SIDED|95.0|11.5|32.1||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||32.1|11.5|<0.001
73811034|NCT04713592|147171408|SUPERIORITY||Rate Difference|20.7|||<|0.001|TWO_SIDED|95.0|9.1|32.2||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||32.2|9.1|<0.001
73811035|NCT04713592|147171409|SUPERIORITY||Rate Difference|16.2|||<|0.001|TWO_SIDED|95.0|8.2|24.3||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||24.3|8.2|<0.001
73811036|NCT02426749|147171428|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73811037|NCT02484651|147171453|SUPERIORITY|||||||0.651|||||||t-test, 2 sided|||Sample size calculation was performed with a power of 0.80 and an α of 0.05, considering the primary hypothesis of a reduction in the BIS variability (measured as the standard deviation). A 25% reduction on the BIS variability (standard deviation) was considered clinically relevant, and gave a minimum sample size of 26 per group.||||0.651
73811038|NCT02484651|147171454|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This statistical analysis applies to the propofol effect-site concentration. Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the propofol drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on propofol mean effect-site concentration of 20% was considered clinically relevant, giving a minimum of 34 patients per group||||<0.001
73811039|NCT02484651|147171454|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||"This statistical analysis applies to the remifentanil effect-site concentration.~Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the remifentanil drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on on remifentanil average effect-site concentration of 20% was considered clinically relevant, giving a minimum of 24 patients per group"||||0.245
73811040|NCT02484651|147171455|SUPERIORITY|||||||0.419|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 15 minutes was independent from the study group.||||0.419
73811041|NCT02484651|147171455|SUPERIORITY|||||||0.107|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 40 minutes was independent from the study group.||||0.107
73811042|NCT02484651|147171456|SUPERIORITY|||||||0.669|||||||Chi-squared|||The null hypothesis was that PQRS satisfaction with anesthetic care was independent of the study group.||||0.669
73896248|NCT01375075|147325952|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.54||0.021|TWO_SIDED|90.0|1.7|10.1||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||10.10|1.70|0.021
73896249|NCT01375075|147325952|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|2.52||0.829|TWO_SIDED|90.0|-4.71|3.62||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.62|-4.71|0.829
73811043|NCT01565369|147171478|SUPERIORITY_OR_OTHER||Fleiss' kappa|0.8547|STANDARD_ERROR_OF_MEAN|0.0282|<|0.0001||95.0||||evaluated at the .05 significance level|Fleiss' kappa|||Fleiss' kappa||||<0.0001
73811044|NCT02266472|147171537|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|99.11|STANDARD_DEVIATION|6.3|<|0.0001|TWO_SIDED|90.0|96.4|101.89|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||101.89|96.40|<0.0001
73811045|NCT02266472|147171538|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints,using an acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|101.25|STANDARD_DEVIATION|10.7|<|0.0001|TWO_SIDED|90.0|96.54|106.19|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||106.19|96.54|<0.0001
73811046|NCT02266472|147171539|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|99.12|STANDARD_DEVIATION|12.9|<|0.0001|TWO_SIDED|90.0|93.69|104.87|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||104.87|93.69|<0.0001
73896250|NCT01375075|147325952|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|1.5||0.603|TWO_SIDED|90.0|-1.69|3.24||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.24|-1.69|0.603
73896251|NCT01375075|147325952|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|1.48||0.656|TWO_SIDED|90.0|-3.11|1.78||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.78|-3.11|0.656
73811047|NCT02266472|147171540|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|108.58|STANDARD_DEVIATION|9.3|<|0.0001|TWO_SIDED|90.0|104.17|113.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||113.17|104.17|<0.0001
73811048|NCT02266472|147171541|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|98.89|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|96.18|101.67|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||101.67|96.18|
73811049|NCT02266472|147171542|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|101.37|STANDARD_DEVIATION|11.0|||TWO_SIDED|90.0|96.53|106.45|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||106.45|96.53|
73811050|NCT00808639|147171543|SUPERIORITY_OR_OTHER||Pathologic response rate|49.0|||||TWO_SIDED|80.0|38.0|61.0||||||This study used a Simon's optimal two-stage design. Of 39 eligible patients, if 18 achieved PaR, the treatment would be declared effective. A two-sided 80% CI was estimated considering the two-stage design based on Atkinson and Brown methods.||61|38|
73811051|NCT00197002|147171548|NON_INFERIORITY_OR_EQUIVALENCE|"The two-sided standardized asymptotic 95% confidence interval (CI) for the difference in seropositivity rates \[Havrix+Prevnar Group minus Havrix Group\] was computed. The anti-HAV seropositivity rates in the Havrix+Prevnar Group were considered as non-inferior to the seropositivity rates in the Havrix Group, if the lower limit of the 95% CI was not lower (≥) than -5%.~The non-inferiority was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Difference in seropositivity rate|-1.06|||||TWO_SIDED|95.0|-5.78|2.45||||||"Difference in seropositivity rates for anti-HAV:~To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10)."||2.45|-5.78|
73811052|NCT00197002|147171549|NON_INFERIORITY_OR_EQUIVALENCE|"The standardized two-sided 95% CI for the GMC ratio (Havrix+Prevnar Group divided by Havrix Group) was computed. The anti-HAV GMC in the Havrix+Prevnar Group was considered as non-inferior to the anti-HAV GMC in the Havrix Group if the lower limit of the 95% CI was not lower than (≥) 0.5.~The non-inferiority of the anti-HAV immune response in Havrix+Prevnar Group compared to Havrix Group was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Adjusted GMC ratio|0.91|||||TWO_SIDED|95.0|0.63|1.31|||ANCOVA|||To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10).||1.31|0.63|
73811053|NCT02017717|147171567|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.3791|TWO_SIDED|95.0|0.89|1.36|||log-rank test stratified|||||1.36|0.89|0.3791
73811054|NCT02017717|147171568|SUPERIORITY||Difference of OS rates at 12 months|-0.5||||0.9208|TWO_SIDED|95.0|-10.8|9.7|||Z test with variance estimation based on|Greenwood formula using log(-log) transformation||||9.7|-10.8|0.9208
73811055|NCT02017717|147171570|SUPERIORITY||Hazard Ratio (HR)|1.88|||||TWO_SIDED|95.0|1.5|2.35||||||||2.35|1.50|
73896252|NCT01375075|147325952|SUPERIORITY_OR_OTHER||LS Mean Difference|1.83|STANDARD_ERROR_OF_MEAN|1.52||0.228|TWO_SIDED|90.0|-0.67|4.34||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||4.34|-0.67|0.228
73811056|NCT02017717|147171571|SUPERIORITY||Odds Ratio (OR)|0.29|||||TWO_SIDED|95.0|0.15|0.59||||||||0.59|0.15|
73811057|NCT02017717|147171572|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.3791|TWO_SIDED|95.0|0.89|1.36|||log-rank test stratified|||||1.36|0.89|0.3791
73811058|NCT03051516|147171596|SUPERIORITY|||||||0.89|||||||Chi-squared|||This p-value compares HPV16 persistence by study arm.||||0.89
73811059|NCT03051516|147171596|SUPERIORITY|||||||0.65|||||||Chi-squared|||This p-value compares HPV18/45 persistence by study arm.||||0.65
73811060|NCT03051516|147171596|SUPERIORITY|||||||0.056|||||||Chi-squared|||This p-value compares HPV31/33/52/58 persistence by study arm.||||0.056
73811061|NCT03051516|147171596|SUPERIORITY|||||||0.38|||||||Chi-squared|||This p-value compares HPV35/39/51/56/59 persistence by study arm.||||0.38
73811062|NCT03051516|147171596|SUPERIORITY|||||||0.33||||||This p-value compares overall HPV persistence and is not specific to HPV genotype.|Chi-squared|||||||0.33
73811063|NCT03051516|147171597|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
73811064|NCT03051516|147171598|OTHER|Descriptive analysis||||||0.135|||||||Chi-squared|||This comparison is specific to the incidence of fever or chills.||||0.135
73811065|NCT03051516|147171598|OTHER|Descriptive analysis||||||0.64|||||||Chi-squared|||This comparison is specific to the incidence of headache.||||0.640
73811066|NCT03051516|147171598|OTHER|Descriptive analysis||||||0.838|||||||Chi-squared|||This comparison is specific to the incidence of fatigue.||||0.838
73811067|NCT03051516|147171598|OTHER|Descriptive analysis||||||0.917|||||||Chi-squared|||This comparison is specific to the incidence of muscle aches.||||0.917
73811068|NCT03051516|147171598|OTHER|Descriptive analysis||||||0.005|||||||Chi-squared|||This comparison is specific to the incidence of pain at injection site.||||0.005
73811069|NCT03051516|147171598|OTHER|Descriptive analysis||||||0.001|||||||Chi-squared|||This comparison is specific to the incidence of tenderness at injection site.||||0.001
73811070|NCT03051516|147171598|OTHER|Descriptive analysis||||||0.004|||||||Chi-squared|||This comparison is specific to the incidence of swelling at injection site.||||0.004
73811071|NCT03051516|147171598|OTHER|Descriptive analysis||||||0.133|||||||Chi-squared|||This comparison is specific to the incidence of medical attention/medication required.||||0.133
73811072|NCT03051516|147171599|SUPERIORITY|||||||0.93|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV16, in Arm I (Vaccine)||||0.93
73811073|NCT03051516|147171599|SUPERIORITY|||||||0.77|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV18, in Arm I (Vaccine)||||0.77
73811074|NCT03051516|147171599|SUPERIORITY|||||||0.57|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV31, in Arm I (Vaccine)||||0.57
73811075|NCT03051516|147171599|SUPERIORITY|||||||0.73|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV33, in Arm I (Vaccine)||||0.73
73811076|NCT03051516|147171599|SUPERIORITY|||||||0.998|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV45, in Arm I (Vaccine)||||0.998
73811077|NCT03051516|147171599|SUPERIORITY|||||||0.93|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV52, in Arm I (Vaccine)||||0.93
73811078|NCT03051516|147171599|SUPERIORITY|||||||0.95|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV58, in Arm I (Vaccine)||||0.95
73811079|NCT03051516|147171599|SUPERIORITY|||||||0.91|||||||Log Rank|||This p-value compares HSIL recurrence and presence of any HPV type, in Arm I (Vaccine)||||0.91
73811080|NCT03051516|147171599|SUPERIORITY|||||||0.22|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV16, in Arm II (Placebo)||||0.22
73811081|NCT03051516|147171599|SUPERIORITY|||||||0.27|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV18, in Arm II (Placebo)||||0.27
73811082|NCT03051516|147171599|SUPERIORITY|||||||0.72|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV31, in Arm II (Placebo)||||0.72
73896253|NCT01375075|147325952|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.51||0.516|TWO_SIDED|90.0|-3.47|1.51||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.51|-3.47|0.516
73896254|NCT01375075|147325953|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|1.11||0.513|TWO_SIDED|90.0|-2.57|1.11|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.11|-2.57|0.513
73811083|NCT03051516|147171599|SUPERIORITY|||||||0.71|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV33, in Arm II (Placebo)||||0.71
73896255|NCT01375075|147325953|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|1.12||0.97|TWO_SIDED|90.0|-1.82|1.9|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.90|-1.82|0.970
73896256|NCT01375075|147325953|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|1.16||0.824|TWO_SIDED|90.0|-1.66|2.17|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.17|-1.66|0.824
73811084|NCT03051516|147171599|SUPERIORITY|||||||0.11|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV45, in Arm II (Placebo)||||0.11
73811085|NCT03051516|147171599|SUPERIORITY|||||||0.58|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV52, in Arm II (Placebo)||||0.58
73811086|NCT03051516|147171599|SUPERIORITY|||||||0.81|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV58, in Arm II (Placebo)||||0.81
73811087|NCT03051516|147171599|SUPERIORITY|||||||0.73|||||||Log Rank|||This p-value compares HSIL recurrence and presence of any HPV type, in Arm II (Placebo)||||0.73
73811088|NCT02339155|147171602|NON_INFERIORITY|If the upper bound of the 90% confidence interval (CI) or the ratio of anti-PA Ab (attributable to AVA) GMCs between the AVA and the AVA + raxibacumab groups at Week 4 is less than 1.5, non-inferiority was to be established.|Ratio|1.18||||0.0016|TWO_SIDED|90.0|1.03|1.35|||t-test, 1 sided|||||1.35|1.03|0.0016
73811089|NCT02339155|147171603|OTHER||Ratio|1.09|||||TWO_SIDED|90.0|0.98|1.22|||t-test, 1 sided||Week 8|||1.22|0.98|
73811090|NCT02339155|147171603|OTHER||Ratio|0.98|||<|0.0001|TWO_SIDED|90.0|0.89|1.07|||t-test, 1 sided||Week 26|||1.07|0.89|<0.0001
73811091|NCT02231879|147171755|SUPERIORITY|This is a two-sided test, with the null hypothesis that the distribution of the difference scores is the same in both arms.||||||0.65||||||Not adjusted for multiple comparisons, since this is the only pre-specified primary analysis. P\<=0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||This was a pre-specified primary analysis plan, and the two arms are compared with a Wilcoxon-Mann-Whitney test on the primary outcome. This is non-standard (since both arms contain both treatment groups), however, it is a valid test by randomization since it is a permutation test. The statistic of TISS in Period 1 minus TISS in Period 2 was chosen so that even if there are carry-over effects this will give a valid test.||||0.65
73811092|NCT02231879|147171755|SUPERIORITY||||||<|0.0001||||||Not adjusted for multiple comparisons, one-sided test, a priori significance set at 0.025|McNemar|||Maintenance of absolute lymphocyte count greater than 1000 cells/microliter measured 3 hours after a dose for plerixafor as compared to G-CSF||||<0.0001
73811093|NCT02231879|147171755|NON_INFERIORITY|Pre-specified non-inferiority margin of 0.40 which was estimated to be about 50% of the effect size of G-CSF versus placebo.||||||0.023||||||Not adjusted for multiple comparisons, one-sided test, a priori significance set at 0.025|McNemar|||Maintenance of absolute neutrophil counts \>500 cells/microliter for G-CSF versus plerixafor measured as the proportion of successes (75% of measured) while on G-CSF minus the proportion on plerixafor||||0.023
73811094|NCT01210495|147171756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907||||0.2872|TWO_SIDED|95.0|0.646|1.274||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio less than (\<) 1 indicated reduction in hazard rate to favor Axitinib; hazard ratio greater than (\>) 1 indicated reduction to favor Placebo.|The study was designed to test the null hypothesis that the true median OS was 5 months vs. the alternative hypothesis that the true median OS was at least 8.3 months (i.e., 66 percent \[%\] improvement in median OS).||1.274|0.646|0.2872
73811095|NCT01210495|147171757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.618||||0.0039|TWO_SIDED|95.0|0.438|0.871||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio \<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \>1 indicated a reduction in favor of Placebo.|||0.871|0.438|0.0039
73811096|NCT01210495|147171758|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.172||||0.0914|TWO_SIDED|95.0|0.759|13.265||ORR for the 2 treatment arms was compared with a significance level of 0.025 using Cochran-Mantel-Haenszel (CMH) test for stratified analyses.|Cochran-Mantel-Haenszel||Risk ratio and confidence interval (CI) were based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.|||13.265|0.759|0.0914
73811097|NCT01210495|147171759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.621||||0.006|TWO_SIDED|95.0|0.434|0.889||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio \<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \>1 indicated a reduction in favor of Placebo.|||0.889|0.434|0.006
73811098|NCT01210495|147171761|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.65||||0.0025|TWO_SIDED|95.0|1.319|5.326||For the overall stratified analysis the p-value is from Cochran-Mantel-Haenszel test of treatment stratified by geographical region and vascular invasion and extra hepatic spread.|Cochran-Mantel-Haenszel||Risk Ratio and CI based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.|||5.326|1.319|0.0025
73811099|NCT01210495|147171770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.89||||0.0006|TWO_SIDED|95.0|-18.7|-5.08||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-5.08|-18.70|0.0006
73811100|NCT01210495|147171771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6||||0.0014|TWO_SIDED|95.0|-12.27|-2.94||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-2.94|-12.27|0.0014
73811101|NCT01210495|147171772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27|||<|0.0001|TWO_SIDED|95.0|-4.76|-1.78||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.78|-4.76|<0.0001
73811102|NCT01210495|147171773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G PWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-2.21|-5.26|<0.0001
73811103|NCT01210495|147171773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||0.1642|TWO_SIDED|95.0|-3.07|0.52||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G SWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.52|-3.07|0.1642
73811104|NCT01210495|147171773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.4759|TWO_SIDED|95.0|-1.8|0.84||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G EWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.84|-1.80|0.4759
73811105|NCT01210495|147171773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07||||0.0288|TWO_SIDED|95.0|-3.92|-0.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G FWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-0.21|-3.92|0.0288
73811106|NCT01210495|147171774|SUPERIORITY||Mean Difference (Final Values)|-4.96||||0.0011|TWO_SIDED|95.0|-7.93|-1.99||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.99|-7.93|0.0011
73896257|NCT01375075|147325953|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.12||0.769|TWO_SIDED|90.0|-2.18|1.52|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.52|-2.18|0.769
73896258|NCT01375075|147325954|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.33||0.735|TWO_SIDED|90.0|-0.65|0.43|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.43|-0.65|0.735
73896259|NCT01375075|147325954|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.33||0.503|TWO_SIDED|90.0|-0.32|0.76|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.76|-0.32|0.503
73896260|NCT01375075|147325954|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.33||0.988|TWO_SIDED|90.0|-0.53|0.54|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.54|-0.53|0.988
73811107|NCT01210495|147171775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.45|||<|0.0001|TWO_SIDED|95.0|-15.49|-5.42||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-5.42|-15.49|<0.0001
73811108|NCT01210495|147171776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.252||||0.9182|TWO_SIDED|95.0|0.923|1.698||The p-value is from a 1-sided log-rank test.|1-sided, unstratified log-rank test||Assuming proportional hazards, a hazard ratio \<1 indicates reduction in hazard rate to favor Axitinib, hazard ratio \>1 indicates reduction to favor Placebo.|||1.698|0.923|0.9182
73811109|NCT01210495|147171777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.0024|TWO_SIDED|95.0|-0.2|-0.04|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-0.04|-0.20|0.0024
73811110|NCT01210495|147171778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.03||||0.0193|TWO_SIDED|95.0|-12.91|-1.15|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.15|-12.91|0.0193
73811111|NCT00454818|147171785|SUPERIORITY_OR_OTHER|||||||0.078||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.078
73811112|NCT00454818|147171785|SUPERIORITY_OR_OTHER|||||||0.515||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.515
73811113|NCT00454818|147171785|SUPERIORITY_OR_OTHER|||||||0.098||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.098
73811114|NCT00640653|147171801|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.67||||0.03|TWO_SIDED|95.0|0.48|0.96||The significance criterion was set at alpha = .05.|generalized linear regression|Log link was specified|Treatment was coded as 1 vs health control coded as 0.|With alpha = .05, 2-tailed, and 37.4% of the control group initiating sexual intercourse by 24-month follow-up, a total sample size of 563 participants completing the trial was projected to provide power of 80% to detect a difference of 16.8% in self-reported sexual intercourse between an HIV intervention condition and the health promotion control condition.||0.96|0.48|.03
73811115|NCT02505334|147171806|SUPERIORITY|Superiority of liraglutide 1.8 mg/day vs. liraglutide 0.9 mg/day was to be considered confirmed if the 95% confidence interval for the treatment difference (liraglutide 1.8 mg/day minus liraglutide 0.9 mg/day) for change from baseline in HbA1c (% of HbA1c) was entirely below 0%, equivalent to a one-sided test with significance level of 2.5%.|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.55|-0.24|||ANCOVA|||Missing data was imputed using the LOCF method. The change from baseline in the response after 26 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline response as a covariate.||-0.24|-0.55|<0.0001
73811116|NCT03379753|147171881|OTHER||U statistic|984.5||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
73811117|NCT01032239|147171882|SUPERIORITY||Hodges-Lehmann|-0.667||||0.014|TWO_SIDED|95.1|-1.0|-0.1667|||Wilcoxon (Mann-Whitney)|||To test the null hypothesis the sample size needed was 44 evaluable patient (22 per arm) with a power of 80 %.||-0.1667|-1.000|0.0140
73811118|NCT01032239|147171883|SUPERIORITY||Hodges-Lehmann|-0.6||||0.0042|TWO_SIDED|95.0|-1.0|-0.2|||Wilcoxon (Mann-Whitney)|||||-0.2000|-1.0000|0.0042
73811119|NCT01032239|147171884|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||0.0540
73811120|NCT01032239|147171885|SUPERIORITY|||||||0.6256|||||||Wilcoxon (Mann-Whitney)|||||||0.6256
73811121|NCT01032239|147171886|SUPERIORITY|||||||0.3676|||||||Cochran-Mantel-Haenszel|||||||0.3676
73811122|NCT01032239|147171887|SUPERIORITY|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Actual Pain||||0.0380
73811123|NCT01032239|147171887|SUPERIORITY|||||||0.0136|||||||Wilcoxon (Mann-Whitney)|||Least Pain||||0.0136
73811124|NCT01032239|147171887|SUPERIORITY|||||||0.2427|||||||Wilcoxon (Mann-Whitney)|||Worst Pain||||0.2427
73896261|NCT01375075|147325954|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.32||0.207|TWO_SIDED|90.0|-0.95|0.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.13|-0.95|0.207
73896262|NCT01375075|147325955|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.43||0.756|TWO_SIDED|90.0|-0.57|0.84|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.84|-0.57|0.756
73811125|NCT01032239|147171888|SUPERIORITY|||||||0.7661|||||||Fisher Exact|||||||0.7661
73811126|NCT01032239|147171889|SUPERIORITY|||||||0.0197|||||||Wilcoxon (Mann-Whitney)|||Utility Score||||0.0197
73811127|NCT01032239|147171889|SUPERIORITY|||||||0.3807|||||||t-test, 2 sided|||VAS||||0.3807
73811128|NCT01032239|147171890|SUPERIORITY|||||||0.1068|||||||t-test, 2 sided|||PCS||||0.1068
73811129|NCT01032239|147171890|SUPERIORITY|||||||0.6824|||||||t-test, 2 sided|||MCS||||0.6824
73811130|NCT01032239|147171891|SUPERIORITY|||||||0.2105|||||||t-test, 2 sided|||||||0.2105
73811131|NCT04972968|147171900|SUPERIORITY||Cox Proportional Hazard|0.49||||0.012|TWO_SIDED|95.0|0.273|0.878||P-value \<= 0.05|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\].||||0.878|0.273|0.012
73811132|NCT04972968|147171900|SUPERIORITY||Cox Proportional Hazard|0.443||||0.004|TWO_SIDED|95.0|0.248|0.794||P-value \<= 0.01|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\]||||0.794|0.248|0.004
73811133|NCT04972968|147171900|SUPERIORITY||Cox Proportional Hazard|0.198|||<|0.001|TWO_SIDED|95.0|0.094|0.419||P-value \<= 0.001|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\]||||0.419|0.094|<0.001
73811134|NCT04972968|147171901|SUPERIORITY||Mean Difference (Net)|18.7||||0.107|TWO_SIDED|95.0|-4.0|41.4|||Cochran-Mantel-Haenszel||From Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid (GC) use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||41.4|-4.0|0.107
73811135|NCT04972968|147171901|SUPERIORITY||Mean Difference (Net)|18.9||||0.092|TWO_SIDED|95.0|-3.1|41.0||P-value ≤ 0.1|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||41.0|-3.1|0.092
73811136|NCT04972968|147171901|SUPERIORITY||Mean Difference (Net)|41.9|||<|0.001|TWO_SIDED|95.0|21.4|62.3||P-value ≤ 0.001|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||62.3|21.4|< 0.001
73811137|NCT04972968|147171902|SUPERIORITY||Mean Difference (Net)|-88.67||||0.144|TWO_SIDED|95.0|-208.04|30.71|||ANCOVA|P-value based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors.|95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[GC use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent);|||30.71|-208.04|0.144
73811138|NCT04972968|147171902|SUPERIORITY||Mean Difference (Net)|-164.76||||0.007|TWO_SIDED|95.0|-283.62|-45.89||P-value ≤ 0.01|ANCOVA||P-value and 95% CI are based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone\] equivalent);|||-45.89|-283.62|0.007
73811139|NCT04972968|147171902|SUPERIORITY||Mean Difference (Final Values)|-182.55||||0.003|TWO_SIDED|95.0|-300.52|-64.58||P-value ≤ 0.01|ANCOVA||P-value and 95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent)|||-64.58|-300.52|0.003
73811140|NCT04972968|147171903|SUPERIORITY||Mean Difference (Net)|-1.58||||0.039|TWO_SIDED|95.0|-3.08|-0.08||P-value \<= 0.05|ANCOVA|P-value based on ANCOVA adjusting for baseline randomization stratification factors (GC use at baseline)||||-0.08|-3.08|0.039
73811141|NCT04972968|147171903|SUPERIORITY||Mean Difference (Final Values)|-2.66|||<|0.001|TWO_SIDED|95.0|-4.15|-1.16||P-value \<= 0.001|ANCOVA|P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|||-1.16|-4.15|<0.001
73811142|NCT04972968|147171903|SUPERIORITY||Mean Difference (Final Values)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.49|-1.52||P-value \<= 0.001|ANCOVA|P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|||-1.52|-4.49|<0.001
73811143|NCT03979807|147171910|OTHER||Adjusted Hazard Ratio|1.11|||||TWO_SIDED|95.0|1.06|1.17|||||Cox proportional hazard model. 'Treatment' is the only Independent variable used to estimate the hazard ratios. Umeclidinium/Vilanterol is Reference Group.|||1.17|1.06|
73811144|NCT02419612|147171931|SUPERIORITY||Least Squares (LS) Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.57|-0.18|||Mixed Models Analysis|Adjusted for for treatment, baseline HbA1c, visit, treatment-by-visit interaction, and baseline HbA1c-by-visit interaction.||||-0.18|-0.57|<0.001
73811145|NCT02419612|147171932|SUPERIORITY||LS Mean Difference|-4.06|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-4.84|-3.28|||Mixed Models Analysis|Adjusted for for treatment, baseline body weight, visit, treatment-by-visit interaction, and baseline body weight-by-visit interaction.||||-3.28|-4.84|<0.001
73811146|NCT02419612|147171933|SUPERIORITY||Odds Ratio (OR)|1.5||||0.044||95.0|1.01|2.29|||Regression, Logistic|Adjusted for baseline HbA1c value||||2.29|1.01|0.044
73811147|NCT02419612|147171934|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|1.35||0.007|TWO_SIDED|95.0|-6.3|-1.0|||Mixed Models Analysis|Adjusted for treatment, baseline SBP, visit, treatment-by-visit interaction, and baseline SBP-by-visit interaction||||-1.0|-6.3|0.007
73811148|NCT02419612|147171935|SUPERIORITY||Hazard Ratio (HR)|0.15||||0.002|TWO_SIDED|95.0|0.04|0.5||This endpoint did not meet the required number of events (n=10) in each treatment arm, hence was excluded from sequential testing.|Regression, Cox Proportional Hazards|||Time to treatment intensification was analyzed using a Cox proportional hazards model.||0.50|0.04|0.002
73811149|NCT02419612|147171936|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.68|||Regression, Cox Proportional Hazards|||Time to treatment intensification was analyzed using a Cox proportional hazards model.||0.68|0.39|<0.001
73811150|NCT02419612|147171937|SUPERIORITY||Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.54||0.006|TWO_SIDED|95.0|1.23|3.42|||Regression, Logistic|Adjusted for baseline HbA1c value.||||3.42|1.23|0.006
73811151|NCT02419612|147171938|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.68|||Regression, Cox Proportional Hazards|||||0.68|0.39|<0.001
73811152|NCT00474045|147171939|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.074||0.4||95.0|-0.21|0.08||P-value for superiority was calculated.|Regression, Linear|Treatment, country, pregnancy (preg.) status at randomisation (random.)-fixed. HbA1c at rand.(covariate) \& at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% confidence interval (CI) was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.||0.08|-0.21|0.400
73811153|NCT00474045|147171940|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.096||0.122||95.0|-0.34|0.04||P-value for superiority was calculated|Regression, Linear|Treatment, country, preg. status at rand.(fixed factors),HbA1c at rand.(covariate),HbA1c at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% CI was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.||0.04|-0.34|0.122
73811154|NCT02278120|147171996|SUPERIORITY||Hazard Ratio, log|0.553|||<|1e-07|TWO_SIDED|95.0|0.441|0.694|||Log Rank|||||0.694|0.441|<0.0000001
73811155|NCT02278120|147171997|SUPERIORITY||Cox Proportional Hazard|0.712||||0.00973|TWO_SIDED|95.0|0.535|0.948||One-sided stratified log-rank test|Log Rank|||||0.948|0.535|0.00973
73811156|NCT02278120|147171998|SUPERIORITY|||||||0.00098|||||||Cochran-Mantel-Haenszel|||||||0.000980
73811157|NCT02278120|147171999|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||||||0.002
73896263|NCT01375075|147325955|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.43||0.99|TWO_SIDED|90.0|-0.71|0.7|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.70|-0.71|0.990
73811158|NCT01187498|147172009|NON_INFERIORITY_OR_EQUIVALENCE|A power analysis indicated that a sample size of 70 per group would provide 80% power with a one-sided alpha of 0.05 to declare two means equivalent, assuming a mean voiding frequency of 8.2 for behavioral treatment, a mean voiding frequency of 8.0 for drug therapy, and a standard deviation of 2.3 for both groups. Equivalence was defined as ±15% of the drug therapy posttreatment mean.|Difference of the Means|0.4|STANDARD_ERROR_OF_MEAN|0.346||0.001||95.0|||||Regression, Linear||The estimated parameter of dispersion is the standard error of the regression coefficient which measured the adjusted difference of the group means.|The primary analysis was an equivalence analysis to compare the two treatment groups on posttreatment 24- hour voiding frequency using a margin of ±15% of the drug group mean. Schuirmann's two one-sided tests (TOST) approach was used first to examine completers and then repeated using last observation carried forward to include participants who did not complete therapy. Adjusting the test to regression, the analyses were repeated using baseline voiding frequency as a covariate.||||.001
73811159|NCT01187498|147172010|SUPERIORITY_OR_OTHER||Difference of the Means|-0.38|STANDARD_ERROR_OF_MEAN|0.188||0.05||95.0|||||Regression, Linear||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.05
73811160|NCT01187498|147172011|SUPERIORITY_OR_OTHER||Difference of Group Means|0.19|STANDARD_ERROR_OF_MEAN|0.091||0.05||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.05
73811161|NCT01187498|147172012|SUPERIORITY_OR_OTHER||Difference in Group Means|-0.14|STANDARD_ERROR_OF_MEAN|0.091||0.33||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.33
73811162|NCT01187498|147172013|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.924||0.84||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.84
73811163|NCT01187498|147172014|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|-0.0563|STANDARD_ERROR_OF_MEAN|0.1249||0.69||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.69
73811164|NCT01187498|147172015|SUPERIORITY_OR_OTHER||Difference between Group Weighted Means|-0.1563|STANDARD_ERROR_OF_MEAN|0.1009||0.16||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.16
73811165|NCT01187498|147172016|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|0.1079|STANDARD_ERROR_OF_MEAN|0.1625||0.56||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.56
73811166|NCT01187498|147172017|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|0.054|STANDARD_ERROR_OF_MEAN|0.1265||0.65||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.65
73811167|NCT01187498|147172018|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.01
73811168|NCT01187498|147172019|SUPERIORITY_OR_OTHER||Difference in Group Proportions|-0.21|STANDARD_ERROR_OF_MEAN|0.086||0.02||95.0|||||Chi-squared||The estimated parameter of dispersion represents the standard error for the difference of the group proportions.|Cochran Mantel-Haenszel procedure.||||.02
73811169|NCT00191282|147172024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.866||95.0|||||Log Rank|||To achieve 80% power, 490 pts need to experience primary combined CV outcome to detect diff. between treatments, assuming: \>=18.5% reduction in incidence of outcomes, 18 mo. pt recruitment, 18 mo. pt follow-up, 10% annual drop-out rate, 2-yr outcome incidence rate of \>=40% (pts in least efficacious treatment), and nominal 2-sided signif. of 0.045.||||0.866
73811170|NCT00191282|147172025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.715||95.0|||||Log Rank|||||||0.715
73811171|NCT00191282|147172026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.914||95.0|||||Log Rank|||||||0.914
73811172|NCT00191282|147172027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.706||95.0|||||Log Rank|||||||0.706
73811173|NCT00191282|147172028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.982||95.0|||||Log Rank|||||||0.982
73811174|NCT00191282|147172029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.816||95.0|||||Log Rank|||||||0.816
73811175|NCT00191282|147172030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.948||95.0|||||Log Rank|||||||0.948
73811176|NCT00191282|147172031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.581||95.0|||||Log Rank|||||||0.581
73811177|NCT00191282|147172032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.647||95.0|||||Log Rank|||||||0.647
73811178|NCT00191282|147172033|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.525||95.0|||||Log Rank|||||||0.525
73811179|NCT00191282|147172034|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8||95.0|||||Log Rank|||||||0.800
73811180|NCT00191282|147172035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.662||95.0|||||Log Rank|||||||0.662
73811181|NCT00191282|147172036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.863||95.0|||||Log Rank|||||||0.863
73811182|NCT00191282|147172037|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.471||95.0|||||Log Rank|||||||0.471
73811183|NCT00191282|147172038|SUPERIORITY_OR_OTHER|||||||0.7168||95.0|||||Chi-squared|||||||0.7168
73811184|NCT00191282|147172040|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Chi-squared|||||||0.0860
73811185|NCT00191282|147172042|SUPERIORITY_OR_OTHER|||||||0.1424||95.0|||||Chi-squared|||||||0.1424
73811186|NCT00191282|147172045|SUPERIORITY_OR_OTHER|||||||0.1957||95.0|||||Chi-squared|||||||0.1957
73811187|NCT00191282|147172047|SUPERIORITY_OR_OTHER|||||||0.2434||95.0|||||Chi-squared|||||||0.2434
73811188|NCT00191282|147172049|SUPERIORITY_OR_OTHER|||||||0.2617||95.0|||||Chi-squared|||||||0.2617
73811189|NCT01726036|147172135|SUPERIORITY_OR_OTHER|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
73811190|NCT01390428|147172136|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|0.73|2.01|||||Mild Hepatic Impairment (HI)/Healthy Matched to Mild HI|Day 1||2.01|0.73|
73811191|NCT01390428|147172136|SUPERIORITY_OR_OTHER||GMR|1.66|||||TWO_SIDED|90.0|1.05|2.61|||||Mild HI/Healthy Matched to Mild HI|Day 10||2.61|1.05|
73811192|NCT01390428|147172136|SUPERIORITY_OR_OTHER||GMR|5.03|||||TWO_SIDED|90.0|2.19|11.56|||||Moderate HI/Healthy Matched to Moderate HI|Day 1||11.56|2.19|
73811193|NCT01390428|147172136|SUPERIORITY_OR_OTHER||GMR|4.82|||||TWO_SIDED|90.0|2.6|8.93|||||Moderate HI/Healthy Matched to Moderate HI|Day 10||8.93|2.60|
73811194|NCT01390428|147172136|SUPERIORITY_OR_OTHER||GMR|19.83|||||TWO_SIDED|90.0|8.11|48.51|||||Severe HI/Healthy Matched to Severe HI|Day 1||48.51|8.11|
73811195|NCT01390428|147172136|SUPERIORITY_OR_OTHER||GMR|11.68|||||TWO_SIDED|90.0|6.1|22.35|||||Severe HI/Healthy Matched to Severe HI|Day 10||22.35|6.10|
73811196|NCT01390428|147172137|SUPERIORITY_OR_OTHER||GMR|0.84|||||TWO_SIDED|90.0|0.35|2.01|||||Mild HI/Healthy Matched to Mild HI|Day 1||2.01|0.35|
73811197|NCT01390428|147172137|SUPERIORITY_OR_OTHER||GMR|1.37|||||TWO_SIDED|90.0|0.83|2.27|||||Mild HI/Healthy Matched to Mild HI|Day 10||2.27|0.83|
73811198|NCT01390428|147172137|SUPERIORITY_OR_OTHER||GMR|7.64|||||TWO_SIDED|90.0|2.74|21.27|||||Moderate HI/Healthy Matched to Moderate HI|Day 1||21.27|2.74|
73811199|NCT01390428|147172137|SUPERIORITY_OR_OTHER||GMR|5.98|||||TWO_SIDED|90.0|2.84|12.57|||||Moderate HI/Healthy Matched to Moderate HI|Day 10||12.57|2.84|
73811200|NCT01390428|147172137|SUPERIORITY_OR_OTHER||GMR|15.18|||||TWO_SIDED|90.0|6.02|38.25|||||Severe HI/Healthy Matched to Severe HI|Day 1||38.25|6.02|
73811201|NCT01390428|147172137|SUPERIORITY_OR_OTHER||GMR|13.01|||||TWO_SIDED|90.0|6.0|28.21|||||Severe HI/Healthy Matched to Severe HI|Day 10||28.21|6.00|
73811202|NCT01390428|147172139|SUPERIORITY_OR_OTHER||GMR|1.86|||||TWO_SIDED|90.0|1.54|2.24|||||Mild HI/Healthy Matched to Mild HI|||2.24|1.54|
73811203|NCT01390428|147172139|SUPERIORITY_OR_OTHER||GMR|2.99|||||TWO_SIDED|90.0|1.31|6.82|||||Moderate HI/Healthy Matched to Moderate HI|||6.82|1.31|
73811204|NCT01390428|147172141|SUPERIORITY_OR_OTHER||GMR|1.92|||||TWO_SIDED|90.0|1.4|2.63|||||Mild HI/Healthy Matched to Mild HI|||2.63|1.40|
73896264|NCT01375075|147325955|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.44||0.565|TWO_SIDED|90.0|-0.47|0.97|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.97|-0.47|0.565
73811205|NCT01390428|147172141|SUPERIORITY_OR_OTHER||GMR|3.59|||||TWO_SIDED|90.0|1.81|7.11|||||Moderate HI/Healthy Matched to Moderate HI|||7.11|1.81|
73811206|NCT01390428|147172141|SUPERIORITY_OR_OTHER||GMR|9.34|||||TWO_SIDED|90.0|4.98|17.51|||||Severe HI/Healthy Matched to Severe HI|||17.51|4.98|
73811207|NCT05897827|147172149|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|3.93||||0.074|TWO_SIDED|95.0|3.73|4.13||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.13|3.73|0.074
73896265|NCT01375075|147325955|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.43||0.678|TWO_SIDED|90.0|-0.53|0.89|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.89|-0.53|0.678
73811208|NCT05897827|147172150|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 75.|Mean|75.47||||0.827|TWO_SIDED|95.0|71.12|79.83||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||79.83|71.12|0.827
73811209|NCT05897827|147172151|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|4.01||||0.003|TWO_SIDED|95.0|3.84|4.17||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.17|3.84|0.003
73811210|NCT05897827|147172152|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|4.01||||0.002|TWO_SIDED|95.0|3.85|4.18||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.18|3.85|0.002
73811211|NCT05897827|147172156|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.22||||0.03|TWO_SIDED|95.0|0.03|0.42||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.42|0.03|0.03
73811212|NCT05897827|147172156|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.01||||0.95|TWO_SIDED|95.0|-0.36|0.38||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.38|-0.36|0.95
73811213|NCT05897827|147172157|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in LGBTQ+ Inclusivity, Awareness, and Advocacy, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.7|||<|0.001|TWO_SIDED|95.0|0.46|0.95||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.95|0.46|<0.001
73811214|NCT05897827|147172157|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in LGBTQ+ Inclusivity, Awareness, and Advocacy, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.45||||0.01|TWO_SIDED|95.0|0.1|0.8||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.80|0.10|0.01
73811215|NCT05897827|147172157|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Identity-Affirming Practices, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.26||||0.001|TWO_SIDED|95.0|0.11|0.41||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.41|0.11|0.001
73811216|NCT05897827|147172157|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Identity-Affirming Practices, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.13||||0.01|TWO_SIDED|95.0|0.03|0.24||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.24|0.03|0.01
73896266|NCT01375075|147325956|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.61||0.856|TWO_SIDED|90.0|-0.9|1.12|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.12|-0.90|0.856
73811217|NCT05897827|147172157|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Inclusivity in Restrooms and Changing Options, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.43||||0.001|TWO_SIDED|95.0|0.18|0.68||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.68|0.18|0.001
73811218|NCT05897827|147172157|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Inclusivity in Restrooms and Changing Options, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.44||||0.04|TWO_SIDED|95.0|0.02|0.86||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.86|0.02|0.04
73811219|NCT05897827|147172158|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.23||||0.1|TWO_SIDED|95.0|-0.5|0.04||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.04|-0.50|0.10
73811220|NCT05897827|147172158|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.24||||0.14|TWO_SIDED|95.0|-0.55|0.07||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.07|-0.55|0.14
73811221|NCT05897827|147172158|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.19||||0.07|TWO_SIDED|95.0|-0.39|0.01||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.01|-0.39|0.07
73811222|NCT05897827|147172158|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.02||||0.85|TWO_SIDED|95.0|-0.18|0.22||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.22|-0.18|0.85
73811223|NCT05897827|147172158|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.15||||0.06|TWO_SIDED|95.0|-0.3|0.01||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.01|-0.30|0.06
73811224|NCT05897827|147172158|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.07||||0.51|TWO_SIDED|95.0|-0.14|0.28||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.28|-0.14|0.51
73811225|NCT05897827|147172158|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.33||||0.001|TWO_SIDED|95.0|0.13|0.53||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.53|0.13|0.001
73811226|NCT05897827|147172158|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.28||||0.04|TWO_SIDED|95.0|0.01|0.55||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.55|0.01|0.04
73811227|NCT05897827|147172158|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.06||||0.36|TWO_SIDED|95.0|-0.19|0.07||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.07|-0.19|0.36
73811228|NCT05897827|147172158|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.03||||0.62|TWO_SIDED|95.0|-0.16|0.1||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.10|-0.16|0.62
73811229|NCT05897827|147172159|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.15||||0.08|TWO_SIDED|95.0|-0.32|0.02||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.02|-0.32|0.08
73811230|NCT05897827|147172159|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.21||||0.2|TWO_SIDED|95.0|-0.55|0.12||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.12|-0.55|0.20
73811231|NCT05897827|147172159|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.02||||0.74|TWO_SIDED|95.0|-0.14|0.1||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.10|-0.14|0.74
73811232|NCT05897827|147172159|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.05||||0.55|TWO_SIDED|95.0|-0.12|0.23||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.23|-0.12|0.55
73811233|NCT05897827|147172159|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.07||||0.4|TWO_SIDED|95.0|-0.22|0.09||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.09|-0.22|0.40
73811234|NCT05897827|147172159|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.12||||0.36|TWO_SIDED|95.0|-0.37|0.13||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.13|-0.37|0.36
73811235|NCT05897827|147172159|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.39|||<|0.001|TWO_SIDED|95.0|0.18|0.6||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.60|0.18|<0.001
73811236|NCT05897827|147172159|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.12||||0.41|TWO_SIDED|95.0|-0.16|0.39||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.39|-0.16|0.41
73811237|NCT05897827|147172159|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.01||||0.92|TWO_SIDED|95.0|-0.22|0.2||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.20|-0.22|0.92
73811238|NCT05897827|147172159|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.14||||0.37|TWO_SIDED|95.0|-0.16|0.44||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.44|-0.16|0.37
73811239|NCT05897827|147172160|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.59||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.59|0.28|<0.001
73811240|NCT05897827|147172160|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.49|||<|0.001|TWO_SIDED|95.0|0.29|0.69||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.69|0.29|<0.001
73811241|NCT02276053|147172166|OTHER||Retention rate|86.0|||||TWO_SIDED|95.0|79.0|93.1|||||"Confidence intervals for the 6-month retention rate were calculated using Greenwood's formula.~Addition of a note: Not all patients had an Observation Period of 6 months."|The retention rate was derived using Kaplan-Meier methodology where patients who completed the study were censored at the date of last administration of LCM in the study.||93.1|79.0|
73811242|NCT04542499|147172191|SUPERIORITY||LS Mean of Difference|1.103|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|0.553|1.653||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||||1.653|0.553|<0.0001
73896267|NCT01375075|147325956|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.869|TWO_SIDED|90.0|-0.9|1.1|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.10|-0.90|0.869
73811243|NCT04542499|147172192|SUPERIORITY||LS Mean of Difference|-0.943|STANDARD_ERROR_OF_MEAN|0.271||0.0006|TWO_SIDED|95.0|-1.475|-0.41||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||||-0.410|-1.475|0.0006
73811244|NCT04542499|147172193|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.188||0.2216|TWO_SIDED|95.0|-0.6|0.139||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 2||0.139|-0.600|0.2216
73811245|NCT04542499|147172193|SUPERIORITY||LS Mean of Difference|0.099|STANDARD_ERROR_OF_MEAN|0.211||0.6379|TWO_SIDED|95.0|-0.316|0.515||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 5||0.515|-0.316|0.6379
73811246|NCT04542499|147172193|SUPERIORITY||LS Mean of Difference|0.582|STANDARD_ERROR_OF_MEAN|0.234||0.0132|TWO_SIDED|95.0|0.122|1.042||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 8||1.042|0.122|0.0132
73811247|NCT04542499|147172193|SUPERIORITY||LS Mean of Difference|0.358|STANDARD_ERROR_OF_MEAN|0.236||0.1299|TWO_SIDED|95.0|-0.106|0.821||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 11||0.821|-0.106|0.1299
73811248|NCT04542499|147172193|SUPERIORITY||LS Mean of Difference|0.698|STANDARD_ERROR_OF_MEAN|0.257||0.0068|TWO_SIDED|95.0|0.194|1.202||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 14||1.202|0.194|0.0068
73811249|NCT04542499|147172193|SUPERIORITY||LS Mean of Difference|0.969|STANDARD_ERROR_OF_MEAN|0.254||0.0002|TWO_SIDED|95.0|0.469|1.469||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 18||1.469|0.469|0.0002
73896268|NCT01375075|147325956|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.869|TWO_SIDED|90.0|-0.92|1.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.13|-0.92|0.869
73811250|NCT04542499|147172193|SUPERIORITY||LS Mean of Difference|0.879|STANDARD_ERROR_OF_MEAN|0.259||0.0008|TWO_SIDED|95.0|0.369|1.389||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 22||1.389|0.369|0.0008
73811251|NCT04542499|147172193|SUPERIORITY||LS Mean of Difference|1.103|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|0.553|1.653||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.653|0.553|<0.0001
73811252|NCT04542499|147172194|SUPERIORITY||LS Mean of Difference|0.108|STANDARD_ERROR_OF_MEAN|0.18||0.5471|TWO_SIDED|95.0|-0.245|0.461||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 2||0.461|-0.245|0.5471
73811253|NCT04542499|147172194|SUPERIORITY||LS Mean of Difference|-0.237|STANDARD_ERROR_OF_MEAN|0.205||0.2488|TWO_SIDED|95.0|-0.64|0.166||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 5||0.166|-0.640|0.2488
73811254|NCT04542499|147172194|SUPERIORITY||LS Mean of Difference|-0.818|STANDARD_ERROR_OF_MEAN|0.221||0.0002|TWO_SIDED|95.0|-1.252|-0.384||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 8||-0.384|-1.252|0.0002
73811255|NCT04542499|147172194|SUPERIORITY||LS Mean of Difference|-0.753|STANDARD_ERROR_OF_MEAN|0.227||0.001|TWO_SIDED|95.0|-1.199|-0.307||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 11||-0.307|-1.199|0.0010
73811256|NCT04542499|147172194|SUPERIORITY||LS Mean of Difference|-0.904|STANDARD_ERROR_OF_MEAN|0.254||0.0004|TWO_SIDED|95.0|-1.403|-0.405||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 14||-0.405|-1.403|0.0004
73811257|NCT04542499|147172194|SUPERIORITY||LS Mean of Difference|-1.024|STANDARD_ERROR_OF_MEAN|0.256|<|0.0001|TWO_SIDED|95.0|-1.528|-0.52||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 18||-0.520|-1.528|<0.0001
73811258|NCT04542499|147172194|SUPERIORITY||LS Mean of Difference|-0.979|STANDARD_ERROR_OF_MEAN|0.261||0.0002|TWO_SIDED|95.0|-1.493|-0.465||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 22||-0.465|-1.493|0.0002
73811259|NCT04542499|147172194|SUPERIORITY||LS Mean of Difference|-0.943|STANDARD_ERROR_OF_MEAN|0.271||0.0006|TWO_SIDED|95.0|-1.475|-0.41||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.410|-1.475|0.0006
73811260|NCT04542499|147172195|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3265|TWO_SIDED|95.0|-0.4|1.2||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part I||1.2|-0.4|0.3265
73811261|NCT04542499|147172195|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.52||0.0203|TWO_SIDED|95.0|-2.2|-0.2||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part II||-0.2|-2.2|0.0203
73811262|NCT04542499|147172195|SUPERIORITY||LS Mean of Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.96||0.0118|TWO_SIDED|95.0|-4.3|-0.5||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part III||-0.5|-4.3|0.0118
73811263|NCT04281784|147172196|SUPERIORITY||Risk Difference (RD)|0.0421||||0.027|TWO_SIDED|95.0|0.0047|0.0777||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Occurrence of discussion regressed on randomization condition, adjusted for ADRD status, hospital, and time between study start \& randomization date.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.0777|0.0047|0.027
73811264|NCT04281784|147172198|SUPERIORITY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.246||0.75|TWO_SIDED|95.0|-0.56|0.404|||Regression, Linear|Outcome (days alive and out of ICU) regressed on Arm/Group (0=usual care, 1=intervention), adjusted for hospital and ADRD status|Robust (HC3) standard error|Superior outcome for Group 2||0.404|-0.560|0.750
73811265|NCT04281784|147172199|SUPERIORITY||Median Difference (Final Values)|-0.361|STANDARD_ERROR_OF_MEAN|0.357||0.312|TWO_SIDED|95.0|-1.06|0.338|||Regression, Linear|Outcome (days alive and out of hospital) regressed on Arm/Group (0=usual care, 1=intervention), adjusted for hospital and ADRD status|Robust (HC3) standard error|Superior outcome for Group 2||0.338|-1.060|0.312
73811266|NCT04281784|147172200|SUPERIORITY||Risk Difference (RD)|0.012||||0.475|TWO_SIDED|95.0|-0.02|0.043||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Readmission (0, 1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.043|-0.020|0.475
73811267|NCT04281784|147172201|SUPERIORITY||Risk Difference (RD)|-0.009||||0.61|TWO_SIDED|95.0|-0.043|0.025||two-sided test, no adjustment for multiple comparisons|Regression, Linear|ICU care (0,1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.025|-0.043|0.610
73811268|NCT04281784|147172202|SUPERIORITY|Higher cost indicates worse outcome. Missing if cost data unavailable from Finance Office.|Slope|0.022|STANDARD_ERROR_OF_MEAN|0.058||0.71|TWO_SIDED|95.0|-0.092|0.135|||other type of regression|Generalized linear model (gamma family, log link); Outcome on study arm (0=control, 1=intervention) adjusted for hospital and ADRD status, robust SEs.|Robust standard error|Superior outcome for Group 2||0.135|-0.092|0.710
73811269|NCT04281784|147172203|SUPERIORITY||Risk Difference (RD)|0.487|STANDARD_ERROR_OF_MEAN|0.899||0.588|TWO_SIDED|95.0|-1.275|2.249||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Died within 30 days after randomization regressed on randomization condition (0=usual care, 1=intervention) adjusted for hospital and ADRD status|Robust standard error|Usual care=reference group; intervention arm = comparison group||2.249|-1.275|0.588
73811270|NCT04281784|147172204|SUPERIORITY|Higher cost indicates worse outcome. Missing if cost data unavailable from Finance Office.|Slope|-0.028|STANDARD_ERROR_OF_MEAN|0.069||0.685|TWO_SIDED|95.0|-0.162|0.107|||other type of regression|Generalized linear model (gamma family, log link); Outcome on study arm (0=control, 1=intervention) adjusted for hospital and ADRD status, robust SEs.|Robust standard error|Superior outcome for Group 2||0.107|-0.162|0.685
73811271|NCT05711381|147172205|OTHER|PK parameters of HM15912 from the severe renal impairment group (Cohort 2) were to be estimated and compared to the control group (Cohort 1, normal renal function). A one-way analysis of variance (ANOVA) was to be used to compare log transformed PK parameters. The estimates of mean difference and corresponding 90% CIs, as well as each exponentiation of estimates, were to be presented to provide the estimates of GMR.|Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.59|1.41||||||||1.41|0.59|
73811272|NCT05711381|147172206|OTHER|PK parameters of HM15912 from the severe renal impairment group (Cohort 2) were to be estimated and compared to the control group (Cohort 1, normal renal function). A one-way analysis of variance (ANOVA) was to be used to compare log transformed PK parameters. The estimates of mean difference and corresponding 90% CIs, as well as each exponentiation of estimates, were to be presented to provide the estimates of GMR.|Geometric mean ratio|1.25|||||TWO_SIDED|90.0|0.93|1.68||||||||1.68|0.93|
73811273|NCT04322539|147172208|SUPERIORITY||Stratified Hazard Ratio|0.662|||<|0.001|TWO_SIDED|95.0|0.549|0.8||Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.|stratified log-rank test||The HR between 2 treatment groups (fruquintinib vs placebo), together with its 95 percent (%) confidence interval (CI), was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.|||0.800|0.549|< .001
73811274|NCT04322539|147172209|SUPERIORITY||Hazard Ratio (HR)|0.321|||<|0.001|TWO_SIDED|95.0|0.267|0.386||Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.|stratified log-rank test||The HR between the 2 treatment groups (fruquintinib vs placebo), together with its 95% CI, was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.|||0.386|0.267|< .001
73811275|NCT04322539|147172210|SUPERIORITY||Adjusted difference|1.5||||0.059|TWO_SIDED|95.0|0.4|2.7||p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.|Cochran-Mantel-Haenszel||The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.|||2.7|0.4|.059
73811276|NCT04322539|147172211|SUPERIORITY||Adjusted difference|39.4|||<|0.001|TWO_SIDED|95.0|32.8|46.0||p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.|Cochran-Mantel-Haenszel||The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.|||46.0|32.8|<.001
73811277|NCT04322539|147172217|OTHER|||||||0.06|||||||Wald test|||CminSS Based on the Starting Dose for OS Exposure-Response Analyses||||0.0600
73896269|NCT01375075|147325956|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|0.61||0.317|TWO_SIDED|90.0|-0.4|1.63|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.63|-0.40|0.317
73811278|NCT04322539|147172217|OTHER|||||||0.8065|||||||Wald test|||CminSS Based on the Adjusted RDI for OS Exposure-Response Analyses||||0.8065
73811279|NCT04322539|147172218|OTHER|||||||0.265|||||||Wald test|||CmaxSS for Gr Dermatological toxicity for Exposure-Response Analyses.||||0.265
73811280|NCT04322539|147172218|OTHER|||||||0.0159|||||||Wald test|||CmaxSS for Gr3+ Dermatological Toxicity for Exposure-Response Analyses.||||0.0159
73811281|NCT04322539|147172218|OTHER|||||||0.484|||||||Wald test|||CmaxSS for Gr Proteinuria for Exposure-Response Analyses.||||0.484
73811282|NCT04322539|147172218|OTHER|||||||0.642|||||||Wald test|||CmaxSS for Gr3+ Proteinuria for Exposure-Response Analyses.||||0.642
73811283|NCT04322539|147172218|OTHER|||||||0.166|||||||Wald test|||CmaxSS for Gr Hemorrhage for Exposure-Response Analyses.||||0.166
73811284|NCT02407132|147172224|SUPERIORITY|||||||0.038||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. 6 months between-arms p-value = 0.139; 12 months between-arms p-value = 0.013. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HbA1c from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.038
73896270|NCT01375075|147325958|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.888|TWO_SIDED|90.0|-0.24|0.2|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.20|-0.24|0.888
73896271|NCT01375075|147325958|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.939|TWO_SIDED|90.0|-0.21|0.23|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.23|-0.21|0.939
73811285|NCT02407132|147172225|SUPERIORITY|||||||0.234||||||The p-value above reflects results of between-arms analysis of change in mean BMI from baseline to immediate post-intervention. 6 months between-arms p-value = 0.552; 12 months between-arms p-value = 0.447. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.234
73811286|NCT02407132|147172226|SUPERIORITY|||||||0.019||||||The p-value above reflects results of between-arms analysis of change in mean total chol from baseline to immediate post-intervention. 6 months between-arms p-value=0.598; 12 months between-arms p-value=0.073. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean Total Cholesterol (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.019
73811287|NCT02407132|147172227|SUPERIORITY|||||||0.186||||||The p-value above reflects results of between-arms analysis of mean change in HDL from baseline to immediate post-intervention. 6 months between-arms p-value=0.009; 12 months between-arms p-value=0.201. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HDL (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.186
73811288|NCT02407132|147172228|SUPERIORITY|||||||0.04||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.040
73811289|NCT02407132|147172229|SUPERIORITY|||||||0.312||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed Effects Logistic Regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.312
73811290|NCT02407132|147172230|SUPERIORITY|||||||0.622||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.622
73811291|NCT02407132|147172231|SUPERIORITY|||||||0.957||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.957
73811292|NCT02407132|147172232|SUPERIORITY|||||||0.147||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.147
73811293|NCT02407132|147172233|SUPERIORITY|||||||0.326||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.326
73811294|NCT01702532|147172237|SUPERIORITY_OR_OTHER||LS Means Difference|-4.9||||0.0141|TWO_SIDED|95.0|-8.8|-0.99||The comparison between treatments was conducted in a hierarchical order; consequently no adjustment of the significance level (5%) for multiplicity was needed.|ANCOVA|ANCOVA model contains pre-provocation baseline, pre-dosing post-provocation craving score, and the terms treatment groups and center as fixed|Comment: The confidence interval is for the difference between treatments groups|Null hypotheses considered change in craving score means from pre-dose post-provocation at 50 seconds to be equal for the two treatment groups.||-0.99|-8.80|0.0141
73811295|NCT03617861|147172239|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.12
73896272|NCT01375075|147325958|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.296|TWO_SIDED|90.0|-0.08|0.36|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.36|-0.08|0.296
73896273|NCT01375075|147325958|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.13||0.181|TWO_SIDED|90.0|-0.04|0.4|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.40|-0.04|0.181
73896274|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.29|STANDARD_ERROR_OF_MEAN|5.97|<|0.001|TWO_SIDED|90.0|-53.16|-33.41||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-33.41|-53.16|<0.001
73811296|NCT03617861|147172239|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.65
73811297|NCT03617861|147172239|SUPERIORITY|||||||0.0574|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.0574
73811298|NCT03617861|147172240|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.85
73811299|NCT03617861|147172240|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.82
73811300|NCT03617861|147172240|SUPERIORITY|||||||0.1451|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.1451
73811301|NCT03617861|147172241|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.85
73811302|NCT03617861|147172241|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||1.0
73811303|NCT03617861|147172241|SUPERIORITY|||||||0.4233|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.4233
73811304|NCT03617861|147172242|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.92
73811305|NCT03617861|147172242|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||1.0
73811306|NCT03617861|147172242|SUPERIORITY|||||||0.3891|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.3891
73896275|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.93|STANDARD_ERROR_OF_MEAN|6.02|<|0.001|TWO_SIDED|90.0|-86.89|-66.97||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-66.97|-86.89|<0.001
73811307|NCT03617861|147172243|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Healthy Secretin vs Healthy Placebo||||0.004
73811308|NCT03617861|147172243|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.03
73811309|NCT03617861|147172243|SUPERIORITY|||||||0.0355|||||||ANCOVA|||Healthy vs Functional Dyspepsia||||0.0355
73811310|NCT03617861|147172244|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Nausea: Healthy Controls Secretin vs Healthy Controls Placebo||||0.5
73811311|NCT03617861|147172244|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Nausea: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.16
73811312|NCT03617861|147172244|SUPERIORITY|||||||0.0016|||||||ANCOVA|||Nausea: Healthy Controls vs Functional Dyspepsia||||0.0016
73811313|NCT03617861|147172244|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Fullness: Healthy Controls Secretin vs Healthy Controls Placebo||||0.10
73811314|NCT03617861|147172244|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Fullness: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.30
73811315|NCT03617861|147172244|SUPERIORITY|||||||0.0002|||||||ANCOVA|||Fullness: Healthy Controls vs Functional Dyspepsia||||0.0002
73811316|NCT03617861|147172244|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Bloating: Healthy Controls Secretin vs Healthy Controls Placebo||||0.41
73811317|NCT03617861|147172244|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Bloating Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.67
73811318|NCT03617861|147172244|SUPERIORITY|||||||0.033|||||||ANCOVA|||Bloating: Healthy Controls vs Functional Dyspepsia||||0.0330
73811319|NCT03617861|147172244|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Abdominal Pain: Healthy Controls Secretin vs Healthy Controls Placebo||||0.25
73811320|NCT03617861|147172244|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Abdominal Pain: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.57
73811321|NCT03617861|147172244|SUPERIORITY|||||||0.2375|||||||ANCOVA|||Abdominal Pain: Healthy Controls vs Functional Dyspepsia||||0.2375
73811322|NCT01846221|147172261|OTHER|||||||0.38|||||||ANOVA|||||||0.38
73811323|NCT01668966|147172269|SUPERIORITY_OR_OTHER|||||||0.101|||||||Paired t-test|||Statistical analysis at Week 12||||0.101
73811324|NCT01668966|147172269|SUPERIORITY_OR_OTHER|||||||0.139|||||||Paired t-test|||Statistical analysis at Week 24||||0.139
73811325|NCT01668966|147172269|SUPERIORITY_OR_OTHER|||||||0.116|||||||Paired t-test|||Statistical analysis at Week 36||||0.116
73811326|NCT01668966|147172269|SUPERIORITY_OR_OTHER|||||||0.167|||||||Paired t-test|||Statistical analysis at Week 48||||0.167
73811327|NCT01668966|147172269|SUPERIORITY_OR_OTHER|||||||0.21|||||||Paired t-test|||Statistical analysis at Week 56||||0.210
73811328|NCT01668966|147172269|SUPERIORITY_OR_OTHER|||||||0.343|||||||Paired t-test|||Statistical analysis at Week 68||||0.343
73811329|NCT01668966|147172269|SUPERIORITY_OR_OTHER|||||||0.533|||||||Paired t-test|||Statistical analysis at Week 80||||0.533
73811330|NCT01668966|147172269|SUPERIORITY_OR_OTHER|||||||0.593|||||||Paired t-test|||Statistical analysis at Week 92||||0.593
73811331|NCT01668966|147172269|SUPERIORITY_OR_OTHER|||||||0.044|||||||Paired t-test|||Statistical analysis at Week 104||||0.044
73811332|NCT01668966|147172269|SUPERIORITY_OR_OTHER|||||||0.243|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.243
73811333|NCT01668966|147172269|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.009
73811334|NCT01668966|147172270|SUPERIORITY_OR_OTHER|||||||0.1853|||||||Paired t-test|||Statistical analysis at Week 12||||0.1853
73811335|NCT01668966|147172270|SUPERIORITY_OR_OTHER|||||||0.2992|||||||Paired t-test|||Statistical analysis at Week 24||||0.2992
73811336|NCT01668966|147172270|SUPERIORITY_OR_OTHER|||||||0.2249|||||||Paired t-test|||Statistical analysis at Week 36||||0.2249
73811337|NCT01668966|147172270|SUPERIORITY_OR_OTHER|||||||0.3102|||||||Paired t-test|||Statistical analysis at Week 48||||0.3102
73811338|NCT01668966|147172270|SUPERIORITY_OR_OTHER|||||||0.2164|||||||Paired t-test|||Statistical analysis at Week 56||||0.2164
73811339|NCT01668966|147172270|SUPERIORITY_OR_OTHER|||||||0.8822|||||||Paired t-test|||Statistical analysis at Week 68||||0.8822
73811340|NCT01668966|147172270|SUPERIORITY_OR_OTHER|||||||0.7649|||||||Paired t-test|||Statistical analysis at Week 80||||0.7649
73811341|NCT01668966|147172270|SUPERIORITY_OR_OTHER|||||||0.605|||||||Paired t-test|||Statistical analysis at Week 92||||0.6050
73811342|NCT01668966|147172270|SUPERIORITY_OR_OTHER|||||||0.4478|||||||Paired t-test|||Statistical analysis at Week 104||||0.4478
73811343|NCT01668966|147172270|SUPERIORITY_OR_OTHER|||||||0.4821|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.4821
73811344|NCT01668966|147172270|SUPERIORITY_OR_OTHER|||||||0.0522|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.0522
73811345|NCT01668966|147172271|SUPERIORITY_OR_OTHER|||||||0.0624|||||||Paired t-test|||Statistical analysis at Week 12||||0.0624
73811346|NCT01668966|147172271|SUPERIORITY_OR_OTHER|||||||0.0616|||||||Paired t-test|||Statistical analysis at Week 24||||0.0616
73811347|NCT01668966|147172271|SUPERIORITY_OR_OTHER|||||||0.248|||||||Paired t-test|||Statistical analysis at Week 36||||0.2480
73811348|NCT01668966|147172271|SUPERIORITY_OR_OTHER|||||||0.5393|||||||Paired t-test|||Statistical analysis at Week 48||||0.5393
73811349|NCT01668966|147172271|SUPERIORITY_OR_OTHER|||||||0.1401|||||||Paired t-test|||Statistical analysis at Week 56||||0.1401
73811350|NCT01668966|147172271|SUPERIORITY_OR_OTHER|||||||0.0679|||||||Paired t-test|||Statistical analysis at Week 68||||0.0679
73811351|NCT01668966|147172271|SUPERIORITY_OR_OTHER|||||||0.6017|||||||Paired t-test|||Statistical analysis at Week 80||||0.6017
73896276|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-90.81|STANDARD_ERROR_OF_MEAN|6.08|<|0.001|TWO_SIDED|90.0|-100.87|-80.75||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-80.75|-100.87|<0.001
73896277|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.25|STANDARD_ERROR_OF_MEAN|5.96|<|0.001|TWO_SIDED|90.0|-77.12|-57.39||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-57.39|-77.12|<0.001
73811352|NCT01668966|147172271|SUPERIORITY_OR_OTHER|||||||0.4772|||||||Paired t-test|||Statistical analysis at Week 92||||0.4772
73811353|NCT01668966|147172271|SUPERIORITY_OR_OTHER|||||||0.4877|||||||Paired t-test|||Statistical analysis at Week 104||||0.4877
73811354|NCT01668966|147172271|SUPERIORITY_OR_OTHER|||||||0.0624|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.0624
73811355|NCT01668966|147172271|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||<0.0001
73811356|NCT01668966|147172272|SUPERIORITY_OR_OTHER|||||||0.2388|||||||Paired t-test|||Statistical analysis at Week 12||||0.2388
73811357|NCT01668966|147172272|SUPERIORITY_OR_OTHER|||||||0.1084|||||||Paired t-test|||Statistical analysis at Week 24||||0.1084
73811358|NCT01668966|147172272|SUPERIORITY_OR_OTHER|||||||0.0321|||||||Paired t-test|||Statistical analysis at Week 36||||0.0321
73811359|NCT01668966|147172272|SUPERIORITY_OR_OTHER|||||||0.0203|||||||Paired t-test|||Statistical analysis at Week 48||||0.0203
73811360|NCT01668966|147172272|SUPERIORITY_OR_OTHER|||||||0.0193|||||||Paired t-test|||Statistical analysis at Week 56||||0.0193
73811361|NCT01668966|147172272|SUPERIORITY_OR_OTHER|||||||0.6235|||||||Paired t-test|||Statistical analysis at Week 68||||0.6235
73811362|NCT01668966|147172272|SUPERIORITY_OR_OTHER|||||||0.2814|||||||Paired t-test|||Statistical analysis at Week 80||||0.2814
73811363|NCT01668966|147172272|SUPERIORITY_OR_OTHER|||||||0.3391|||||||Paired t-test|||Statistical analysis at Week 92||||0.3391
73811364|NCT01668966|147172272|SUPERIORITY_OR_OTHER|||||||0.1605|||||||Paired t-test|||Statistical analysis at Week 104||||0.1605
73811365|NCT01668966|147172272|SUPERIORITY_OR_OTHER|||||||0.4312|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.4312
73811366|NCT01668966|147172275|SUPERIORITY_OR_OTHER|||||||0.934|||||||Paired t-test|||Statistical analysis at Week 12||||0.934
73811367|NCT01668966|147172275|SUPERIORITY_OR_OTHER|||||||0.624|||||||Paired t-test|||Statistical analysis at Week 24||||0.624
73811368|NCT01668966|147172275|SUPERIORITY_OR_OTHER|||||||0.642|||||||Paired t-test|||Statistical analysis at Week 36||||0.642
73811369|NCT01668966|147172275|SUPERIORITY_OR_OTHER|||||||0.952|||||||Paired t-test|||Statistical analysis at Week 48||||0.952
73811370|NCT01668966|147172275|SUPERIORITY_OR_OTHER|||||||0.928|||||||Paired t-test|||Statistical analysis at Week 56||||0.928
73811371|NCT01668966|147172275|SUPERIORITY_OR_OTHER|||||||0.832|||||||Paired t-test|||Statistical analysis at Week 68||||0.832
73811372|NCT01668966|147172275|SUPERIORITY_OR_OTHER|||||||0.315|||||||Paired t-test|||Statistical analysis at Week 80||||0.315
73811373|NCT01668966|147172275|SUPERIORITY_OR_OTHER|||||||0.485|||||||Paired t-test|||Statistical analysis at Week 92||||0.485
73811374|NCT01668966|147172275|SUPERIORITY_OR_OTHER|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 104||||0.246
73811375|NCT01668966|147172275|SUPERIORITY_OR_OTHER|||||||0.375|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.375
73811376|NCT01668966|147172275|SUPERIORITY_OR_OTHER|||||||0.185|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.185
73811377|NCT01668966|147172276|SUPERIORITY_OR_OTHER|||||||0.445|||||||Paired t-test|||Statistical analysis at Week 12||||0.445
73811378|NCT01668966|147172276|SUPERIORITY_OR_OTHER|||||||0.414|||||||Paired t-test|||Statistical analysis at Week 24||||0.414
73811379|NCT01668966|147172276|SUPERIORITY_OR_OTHER|||||||0.401|||||||Paired t-test|||Statistical analysis at Week 36||||0.401
73811380|NCT01668966|147172276|SUPERIORITY_OR_OTHER|||||||0.92|||||||Paired t-test|||Statistical analysis at Week 48||||0.920
73811381|NCT01668966|147172276|SUPERIORITY_OR_OTHER|||||||0.834|||||||Paired t-test|||Statistical analysis at Week 56||||0.834
73811382|NCT01668966|147172276|SUPERIORITY_OR_OTHER|||||||0.539|||||||Paired t-test|||Statistical analysis at Week 68||||0.539
73811383|NCT01668966|147172276|SUPERIORITY_OR_OTHER|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 80||||0.246
73811384|NCT01668966|147172276|SUPERIORITY_OR_OTHER|||||||0.602|||||||Paired t-test|||Statistical analysis at Week 92||||0.602
73811385|NCT01668966|147172276|SUPERIORITY_OR_OTHER|||||||0.218|||||||Paired t-test|||Statistical analysis at Week 104||||0.218
73811386|NCT01668966|147172276|SUPERIORITY_OR_OTHER|||||||0.208|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.208
73811387|NCT01668966|147172276|SUPERIORITY_OR_OTHER|||||||0.101|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.101
73811388|NCT01668966|147172277|SUPERIORITY_OR_OTHER|||||||0.565|||||||Paired t-test|||Statistical analysis at Week 12||||0.565
73811389|NCT01668966|147172277|SUPERIORITY_OR_OTHER|||||||0.637|||||||Paired t-test|||Statistical analysis at Week 24||||0.637
73811390|NCT01668966|147172277|SUPERIORITY_OR_OTHER|||||||0.594|||||||Paired t-test|||Statistical analysis at Week 36||||0.594
73811391|NCT01668966|147172277|SUPERIORITY_OR_OTHER|||||||0.788|||||||Paired t-test|||Statistical analysis at Week 48||||0.788
73811392|NCT01668966|147172277|SUPERIORITY_OR_OTHER|||||||0.329|||||||Paired t-test|||Statistical analysis at Week 56||||0.329
73811393|NCT01668966|147172277|SUPERIORITY_OR_OTHER|||||||0.716|||||||Paired t-test|||Statistical analysis at Week 68||||0.716
73811394|NCT01668966|147172277|SUPERIORITY_OR_OTHER|||||||0.119|||||||Paired t-test|||Statistical analysis at Week 80||||0.119
73811395|NCT01668966|147172277|SUPERIORITY_OR_OTHER|||||||0.201|||||||Paired t-test|||Statistical analysis at Week 92||||0.201
73811396|NCT01668966|147172277|SUPERIORITY_OR_OTHER|||||||0.087|||||||Paired t-test|||Statistical analysis at Week 104||||0.087
73811397|NCT01668966|147172277|SUPERIORITY_OR_OTHER|||||||0.116|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.116
73811398|NCT01668966|147172277|SUPERIORITY_OR_OTHER|||||||0.07|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.070
73811399|NCT01668966|147172278|SUPERIORITY_OR_OTHER|||||||0.3299|||||||Paired t-test|||Statistical analysis at Week 12||||0.3299
73811400|NCT01668966|147172278|SUPERIORITY_OR_OTHER|||||||0.9247|||||||Paired t-test|||Statistical analysis at Week 24||||0.9247
73811401|NCT01668966|147172278|SUPERIORITY_OR_OTHER|||||||0.9602|||||||Paired t-test|||Statistical analysis at Week 36||||0.9602
73811402|NCT01668966|147172278|SUPERIORITY_OR_OTHER|||||||0.2773|||||||Paired t-test|||Statistical analysis at Week 48||||0.2773
73811403|NCT01668966|147172278|SUPERIORITY_OR_OTHER|||||||0.5031|||||||Paired t-test|||Statistical analysis at Week 56||||0.5031
73811404|NCT01668966|147172278|SUPERIORITY_OR_OTHER|||||||0.8109|||||||Paired t-test|||Statistical analysis at Week 68||||0.8109
73811405|NCT01668966|147172278|SUPERIORITY_OR_OTHER|||||||0.254|||||||Paired t-test|||Statistical analysis at Week 80||||0.2540
73811406|NCT01668966|147172278|SUPERIORITY_OR_OTHER|||||||0.3794|||||||Paired t-test|||Statistical analysis at Week 92||||0.3794
73811407|NCT01668966|147172278|SUPERIORITY_OR_OTHER|||||||0.8687|||||||Paired t-test|||Statistical analysis at Week 104||||0.8687
73811408|NCT01668966|147172278|SUPERIORITY_OR_OTHER|||||||0.4685|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.4685
73811409|NCT01668966|147172278|SUPERIORITY_OR_OTHER|||||||0.0511|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.0511
73811410|NCT01643798|147172302|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
73811411|NCT01643798|147172302|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
73811412|NCT01643798|147172303|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANOVA|||||||.0003
73811413|NCT01643798|147172303|SUPERIORITY_OR_OTHER|||||||0.794||95.0|||||ANOVA|||||||0.794
73811414|NCT02634268|147172353|SUPERIORITY||Mean Difference (Final Values)|42.3||||0.02|TWO_SIDED|95.0|7.93|76.6|||Mixed Models Analysis|Difference in average six minute walk test distance at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month six minute walk test distance between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||76.6|7.93|.02
73811415|NCT02634268|147172354|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0008|TWO_SIDED|95.0|-0.63|-0.09|||Mixed Models Analysis|Difference in average Modified Borg Scale score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Modified Borg Scale score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.09|-0.63|.0008
73811416|NCT02634268|147172355|SUPERIORITY||Mean Difference (Final Values)|-1.34||||0.0008|TWO_SIDED|95.0|-2.33|-0.34|||Mixed Models Analysis|Difference in average body weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month body weight between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.34|-2.33|0.0008
73811417|NCT02634268|147172356|SUPERIORITY||Mean Difference (Final Values)|1.48||||0.01|TWO_SIDED|95.0|0.35|2.6|||Mixed Models Analysis|Difference in average SF-12 PCS at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||2.60|0.35|0.01
73811418|NCT02634268|147172357|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.45|TWO_SIDED|95.0|-0.84|1.89|||Mixed Models Analysis|Difference in average SF-12 MCS at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 MCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||1.89|-0.84|0.45
73811419|NCT02634268|147172358|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.009|TWO_SIDED|95.0|-0.71|-0.1|||Mixed Models Analysis|Difference in average Framingham Risk Score at 12 months between control and intervention groups.||Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Framingham Risk Score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.10|-0.71|0.009
73811420|NCT02634268|147172359|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.13|TWO_SIDED|95.0|-2.12|0.26|||Mixed Models Analysis|Difference in average waist circumference at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month waist circumference between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||0.26|-2.12|0.13
73811421|NCT02634268|147172360|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.64|TWO_SIDED|95.0|-3.02|1.84|||Mixed Models Analysis|Difference in average 12 month systolic blood at 12 months between control and intervention groups|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month systolic blood pressure between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||1.84|-3.02|0.64
73811422|NCT02634268|147172361|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.004|TWO_SIDED|95.0|-0.85|-0.17|||Mixed Models Analysis|Difference in average BMI at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month BMI between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.17|-0.85|0.004
73811423|NCT02634268|147172362|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.09|TWO_SIDED|95.0|-4.87|0.36|||Mixed Models Analysis|Difference in average SGRQ-C Symptom score at 12 months between control and intervention groups.||Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Symptom score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|0.36|-4.87|0.09
73811424|NCT02634268|147172363|SUPERIORITY||Mean Difference (Final Values)|-2.31||||0.12|TWO_SIDED|95.0|-5.19|0.56|||Mixed Models Analysis|Difference in average SGRQ-C Activity score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Activity score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||0.56|-5.19|0.12
73811425|NCT02634268|147172364|SUPERIORITY||Mean Difference (Final Values)|-2.72||||0.03|TWO_SIDED|95.0|-5.19|-0.25|||Mixed Models Analysis|Difference in average SGRQ-C Impact score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Impact score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.25|-5.19|0.03
73811426|NCT02634268|147172365|SUPERIORITY||Mean Difference (Final Values)|-2.42||||0.03|TWO_SIDED|95.0|-4.55|-0.28|||Mixed Models Analysis|Difference in average SGRQ-C Total score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SGRQ-C Total score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.28|-4.55|0.03
73811427|NCT02052596|147172383|NON_INFERIORITY|Criteria for non-inferiority: At one month after the last vaccine dose (Month 3 or Month 5), the upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies GMC ratio between the Control Group and the GSK1437173A Group had to be below (\<) 1.5,|Adjusted GMC ratio|1.11|||||TWO_SIDED|95.0|1.02|1.21||||Adjustment for baseline concentration and age - pooled variance.||Demonstration of non-inferiority of the humoral immune response to two doses of the GSK1437173A vaccine when Boostrix vaccine was co-administered with the first GSK1437173A vaccine dose compared to two doses of GSK1437173A vaccine (administered separately from Boostrix vaccine), one month after the last vaccine dose.||1.21|1.02|
73811428|NCT02052596|147172384|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PT antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.17|||||TWO_SIDED|95.0|1.0|1.36||||Ancova model: adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertussis toxoid (PT), one month after the vaccine dose.||1.36|1.00|
73811429|NCT02052596|147172384|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-FHA antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.24|||||TWO_SIDED|95.0|1.07|1.44||||Adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for filamentous hemagglutinin (FHA) antigen, one month after the vaccine dose.||1.44|1.07|
73896278|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|6.21|<|0.001|TWO_SIDED|90.0|-52.88|-32.33||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-32.33|-52.88|<0.001
73811430|NCT02052596|147172384|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PRN antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.27|||||TWO_SIDED|95.0|1.02|1.58||||Adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertactin (PRN) antigen, one month after the vaccine dose.||1.58|1.02|
73811431|NCT02052596|147172385|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-diphtheria (anti-D) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be \< 10%.|Difference in seropositivity rate|-0.1|||||TWO_SIDED|95.0|-3.03|2.85||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for diphteria (D) antigen, one month after the vaccine dose.||2.85|-3.03|
73811432|NCT02052596|147172385|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-tetanus (anti-T) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be \< 10%.|Difference in seropositivity rate|0.01|||||TWO_SIDED|95.0|-1.18|1.27||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for tetanus (T) antigen, one month after the vaccine dose.||1.27|-1.18|
73811433|NCT02938949|147172480|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
73811434|NCT02938949|147172481|SUPERIORITY||||||>|0.2|||||||ANOVA|||||||> 0.20
73811435|NCT02938949|147172482|SUPERIORITY||||||>|0.2|||||||ANOVA|||||||>0.20
73811436|NCT00514904|147172582|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] greater than or equal to (≥) -10%.|Difference in percentage|14.77|||||TWO_SIDED|95.0|10.26|20.23||||||||20.23|10.26|
73811437|NCT00514904|147172582|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|24.47|||||TWO_SIDED|95.0|17.52|31.87||||||||31.87|17.52|
73811438|NCT00514904|147172582|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|6.35|||||TWO_SIDED|95.0|2.68|11.08|||Difference in percentage|||||11.08|2.68|
73811439|NCT00514904|147172582|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|23.92|||||TWO_SIDED|95.0|18.02|30.3||||||||30.3|18.02|
73811440|NCT00514904|147172583|NON_INFERIORITY|Criterion for assessment: upper limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the ratio between Nimenrix Group and Mencevax ACWY Group being lower than or equal to the pre-defined clinical limit ratio of 3.0 in the percentage of subjects with any grade 3 general symptoms.|Risk Ratio (RR)|3.34||||0.2202|TWO_SIDED|95.0|0.56|20.25|||Chi-squared|||||20.25|0.56|0.2202
73811441|NCT02417961|147172604|SUPERIORITY_OR_OTHER||Percentage|98.2||||||95.0|93.81|99.79|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12)|||99.79|93.81|
73811442|NCT02417961|147172604|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|94.99|99.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 16)|||99.98|94.99|
73811443|NCT02417961|147172604|SUPERIORITY_OR_OTHER||Percentage|93.0|||||TWO_SIDED|95.0|86.64|96.92|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 and 16)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12 and 16)|||96.92|86.64|
73811444|NCT02417961|147172605|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|95.21|99.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients returned functional APFS administered at home (Week 12)|||99.98|95.21|
73811445|NCT02417961|147172605|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|94.99|99.98|||Clopper Pearson Exact CI|One sample confidence interval (Week 16)|Percentage of patients returned functional APFS administered at home (Week 16)|||99.98|94.99|
73811446|NCT02417961|147172606|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.13|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0)|Percentage of mulfunctioning APFS used to administer benralizumab at home or clinic (Week 0)|||3.13|0.00|
73811447|NCT02417961|147172606|SUPERIORITY_OR_OTHER||Percentage|0.9|||||TWO_SIDED|95.0|0.02|4.67|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 4)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 4)|||4.67|0.02|
73811448|NCT02417961|147172606|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.16|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 8)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 8)|||3.16|0.00|
73811449|NCT02417961|147172606|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.13|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12)|||3.13|0.00|
73811450|NCT02417961|147172606|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.33|||Clopper-Pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 16)|||3.33|0|
73811451|NCT02417961|147172606|SUPERIORITY_OR_OTHER||Percentage|0.3|||||TWO_SIDED|95.0|0.01|1.59|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 8)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 8)|||1.59|0.01|
73811452|NCT02417961|147172606|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|1.63|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 to 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12 to 16)|||1.63|0.00|
73811453|NCT02417961|147172606|SUPERIORITY_OR_OTHER||Percentage|0.2|||||TWO_SIDED|95.0|0.0|0.97|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 16)|||0.97|0.00|
73811454|NCT03408444|147172706|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.063|STANDARD_ERROR_OF_MEAN|0.0181|||TWO_SIDED|95.0|-0.106|-0.02|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.020|-0.106|
73811455|NCT03408444|147172706|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.056|STANDARD_ERROR_OF_MEAN|0.0183|||TWO_SIDED|95.0|-0.1|-0.013|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.013|-0.100|
73811456|NCT03408444|147172706|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.105|STANDARD_ERROR_OF_MEAN|0.0184|||TWO_SIDED|95.0|-0.149|-0.062|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.062|-0.149|
73811457|NCT03408444|147172707|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|Kenward and Roger method was for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.21|-0.04|
73811458|NCT03408444|147172707|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.01|0.25|||Mixed Models Analysis|Kenward and Roger method was used for the denominator degrees of freedom|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.25|-0.01|
73811459|NCT03408444|147172707|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|0.09|0.35|||Mixed Models Analysis|Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.35|0.09|
73811460|NCT01473394|147172711|SUPERIORITY_OR_OTHER||Least square mean difference|-5.117|||<|1e-05|TWO_SIDED|95.0|-6.886|-3.347|||Mixed-effects model for repeated measure|||||-3.347|-6.886|<0.00001
73811461|NCT01473394|147172712|SUPERIORITY_OR_OTHER||Least square mean difference|-0.622|||<|1e-05|TWO_SIDED|95.0|-0.845|-0.399|||Mixed-effects model for repeated measure|||||-0.399|-0.845|<0.00001
73811462|NCT01473394|147172713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2||||0.0047|TWO_SIDED|95.0|3.0|17.4|||Cochran-Mantel-Haenszel||The Mean Difference (Final Values), as well as the 95% Confidence Interval, are in units of percentage.|||17.4|3.0|0.0047
73811463|NCT01482962|147172716|SUPERIORITY||Odds Ratio (OR)|0.6||||0.038|TWO_SIDED|95.0|0.33|1.08||P-value was stratified using disease type, International Prognostic Index (IPI) Score and region as stratification factors.|Cochran-Mantel-Haenszel|||||1.08|0.33|0.038
73811464|NCT01482962|147172717|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.177|TWO_SIDED|95.0|0.637|1.178|||Stratified Log Rank||Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.178|0.637|0.177
73811465|NCT01482962|147172718|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.338|TWO_SIDED|95.0|0.707|1.369|||Stratified Log-rank Test||Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.369|0.707|0.338
73811466|NCT01482962|147172723|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.362|TWO_SIDED|95.0|0.679|1.329|||Stratified Log Rank||Hazard ratio was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.329|0.679|0.362
73811467|NCT00001656|147172763|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||.04
73811468|NCT00001656|147172764|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.21
73811469|NCT00001656|147172765|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANCOVA|||Analysis of covariance with baseline score as covariate||||0.35
73811470|NCT00001656|147172766|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.19
73811471|NCT00001656|147172767|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.59
73811472|NCT00001656|147172768|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANCOVA|||Analysis of covariance with baseline score as covariate||||0.72
73811473|NCT00001656|147172769|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.27
73811474|NCT00001656|147172770|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|Covariate is baseline score||||||0.11
73811475|NCT00001656|147172771|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
73811476|NCT00001656|147172772|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|||||||0.76
73811477|NCT00001656|147172774|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.73
73811478|NCT01537068|147172812|SUPERIORITY_OR_OTHER||Test of Within-subjects effects|2.95||||0.09|TWO_SIDED||||||Mixed Models Analysis|Repeated Measures of ANOVA||||||0.09
73811479|NCT01537068|147172814|SUPERIORITY_OR_OTHER||Chi-squared|6.32||||0.025|TWO_SIDED||||||Chi-squared|||||||0.025
73811480|NCT00483704|147172815|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54|||<|0.001|TWO_SIDED|95.0|1.8|3.58|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.58|1.80|<0.001
73811481|NCT00483704|147172815|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|2.15|4.27|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.27|2.15|<0.001
73811482|NCT00483704|147172816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|2.35|3.9|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.90|2.35|<0.001
73811483|NCT00483704|147172816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||<|0.001|TWO_SIDED|95.0|2.17|3.61|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.61|2.17|<0.001
73811484|NCT00483704|147172817|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.001|TWO_SIDED|95.0|2.05|7.23|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||7.23|2.05|<0.001
73811485|NCT00483704|147172817|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18|||<|0.001|TWO_SIDED|95.0|3.36|11.39|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||11.39|3.36|<0.001
73811486|NCT00483704|147172818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.001|TWO_SIDED|95.0|1.96|3.51|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.51|1.96|<0.001
73811487|NCT00483704|147172818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23|||<|0.001|TWO_SIDED|95.0|2.41|4.34|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.34|2.41|<0.001
73811488|NCT00483704|147172819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.3|2.11|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.11|1.30|<0.001
73811489|NCT00483704|147172819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.31|2.14|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.14|1.31|<0.001
73811490|NCT00483704|147172820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.36|2.22|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.22|1.36|<0.001
73811491|NCT00483704|147172820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||<|0.001|TWO_SIDED|95.0|1.26|2.06|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.06|1.26|<0.001
73896279|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.93|STANDARD_ERROR_OF_MEAN|6.17|<|0.001|TWO_SIDED|90.0|-89.15|-68.71||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-68.71|-89.15|<0.001
73811492|NCT00483704|147172821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.17|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.17|1.28|<0.001
73811493|NCT00483704|147172821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57|||<|0.001|TWO_SIDED|95.0|1.21|2.04|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.04|1.21|<0.001
73811494|NCT00483704|147172824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.001|TWO_SIDED|95.0|1.78|4.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.07|1.78|<0.001
73811495|NCT00483704|147172824|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45|||<|0.001|TWO_SIDED|95.0|2.3|5.19|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.19|2.30|<0.001
73811496|NCT00483704|147172825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.56|3.69|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.69|1.56|<0.001
73811497|NCT00483704|147172825|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.22|5.12|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.12|2.22|<0.001
73811498|NCT00483704|147172826|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.001|TWO_SIDED|95.0|1.65|3.38|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.38|1.65|<0.001
73811499|NCT00483704|147172826|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.81|||<|0.001|TWO_SIDED|95.0|1.97|4.01|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.01|1.97|<0.001
73811500|NCT00483704|147172827|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.32|||<|0.001|TWO_SIDED|95.0|1.52|3.54|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.54|1.52|<0.001
73811501|NCT00483704|147172827|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02|||<|0.001|TWO_SIDED|95.0|2.0|4.56|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.56|2.00|<0.001
73811502|NCT04442269|147172828|SUPERIORITY||Mean Difference|0.201||||0.0022|TWO_SIDED|95.0|0.0768|0.3256|||Mixed Models Analysis|||||0.3256|0.0768|0.0022
73811503|NCT04450407|147172848|NON_INFERIORITY|The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% CI (Confidence Interval) is below 0.4.|LS Mean Difference|0.17|||||TWO_SIDED|90.0|0.01|0.32||||||||0.32|0.01|
73811504|NCT00962091|147172925|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.9|||||TWO_SIDED|90.0|1.52|2.37|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=OS-PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||2.37|1.52|
73811505|NCT00962091|147172926|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|1.08|1.78|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=OS-PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.78|1.08|
73811506|NCT00962091|147172932|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.66|1.06|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.06|0.66|
73811507|NCT00962091|147172933|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.8|1.34|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.34|0.80|
73811508|NCT00962091|147172934|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|90.0|0.68|1.32|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUC values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.32|0.68|
73811509|NCT02326298|147172939|SUPERIORITY||Odds Ratio (OR)|28.962|||<|0.0001|TWO_SIDED|97.5|6.968|120.371||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||120.371|6.968|<0.0001
73811510|NCT02326298|147172939|SUPERIORITY||Odds Ratio (OR)|45.66|||<|0.0001|TWO_SIDED|97.5|10.657|195.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||195.634|10.657|<0.0001
73811511|NCT02326298|147172939|SUPERIORITY||Estimated difference in responder rate|60.0|||||TWO_SIDED|95.0|47.92|72.17|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||72.17|47.92|
73811512|NCT02326298|147172939|SUPERIORITY||Estimated difference in responder rate|69.3|||||TWO_SIDED|95.0|57.65|80.99|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||80.99|57.65|
73811513|NCT02326298|147172940|SUPERIORITY||Odds Ratio (OR)|20.116|||<|0.0001|TWO_SIDED|97.5|3.699|109.399||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||109.399|3.699|<0.0001
73811514|NCT02326298|147172940|SUPERIORITY||Odds Ratio (OR)|31.143|||<|0.0001|TWO_SIDED|97.5|5.687|170.548||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||170.548|5.687|<0.0001
73811515|NCT02326298|147172940|SUPERIORITY||Estimated difference in responder rate|42.8|||||TWO_SIDED|95.0|30.7|54.86|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||54.86|30.70|
73811516|NCT02326298|147172940|SUPERIORITY||Estimated difference in responder rate|53.6|||||TWO_SIDED|95.0|41.33|65.94|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||65.94|41.33|
73811517|NCT02326298|147172941|SUPERIORITY||Odds Ratio (OR)|36.668|||<|0.0001|TWO_SIDED|97.5|5.717|235.193||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment,region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||235.193|5.717|<0.0001
73811518|NCT02326298|147172941|SUPERIORITY||Odds Ratio (OR)|50.606|||<|0.0001|TWO_SIDED|97.5|7.88|324.988||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||324.988|7.880|<0.0001
73811519|NCT02326298|147172941|SUPERIORITY||Estimated difference in responder rate|35.4|||||TWO_SIDED|95.0|20.85|49.87|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||49.87|20.85|
73811520|NCT02326298|147172941|SUPERIORITY||Estimated difference in responder rate|43.1|||||TWO_SIDED|95.0|27.56|58.71|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||58.71|27.56|
73811521|NCT02326298|147172942|SUPERIORITY||Adjusted Mean Treatment Differences|-6.0|||<|0.0001|TWO_SIDED|97.5|-8.18|-3.81||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-3.81|-8.18|<0.0001
73811522|NCT02326298|147172942|SUPERIORITY||Ajusted Mean Treatment Differences|-6.84|||<|0.0001|TWO_SIDED|97.5|-9.05|-4.62||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-4.62|-9.05|<0.0001
73811523|NCT02086682|147172945|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
73811524|NCT01632904|147172962|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.139|TWO_SIDED|95.0|0.82|4.04|||Chi-squared|||||4.04|0.82|0.139
73811525|NCT00715104|147172965|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|16.2||||1|TWO_SIDED|95.0|1.7|30.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||30.7|1.7|1.000
73811526|NCT00715104|147172965|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|18.9||||1|TWO_SIDED|95.0|3.5|34.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||34.3|3.5|1.000
73896280|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.67|STANDARD_ERROR_OF_MEAN|6.29|<|0.001|TWO_SIDED|90.0|-104.08|-83.26||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-83.26|-104.08|<0.001
73896281|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.01|STANDARD_ERROR_OF_MEAN|6.31|<|0.001|TWO_SIDED|90.0|-85.46|-64.57||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-64.57|-85.46|<0.001
73811527|NCT00715104|147172965|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|70.3|||<|0.001|TWO_SIDED|95.0|52.3|88.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||88.3|52.3|<0.001
73811528|NCT00715104|147172966|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|20.6||||1|TWO_SIDED|95.0|4.0|37.2||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||37.2|4.0|1.000
73811529|NCT00715104|147172966|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|32.4||||0.014|TWO_SIDED|95.0|13.1|51.6||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||51.6|13.1|0.014
73811530|NCT00715104|147172966|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|79.4|||<|0.001|TWO_SIDED|95.0|62.8|96.0||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||96.0|62.8|<0.001
73811531|NCT00715104|147172967|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|35.1||||0.002|TWO_SIDED|95.0|16.3|53.9||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||53.9|16.3|0.002
73811532|NCT00715104|147172967|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|29.7||||0.036|TWO_SIDED|95.0|11.7|47.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||47.7|11.7|0.036
73811533|NCT00715104|147172967|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|83.8|||<|0.001|TWO_SIDED|95.0|69.3|98.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||98.3|69.3|<0.001
73811534|NCT00715104|147172968|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||<0.001
73811535|NCT00715104|147172969|SUPERIORITY_OR_OTHER|||||||0.173|TWO_SIDED|||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||Repeated measure analysis of variance (ANOVA) methods with a mixed model approach was used. The ranked data were used in the statistical model.||||0.173
73811536|NCT00715104|147172970|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED|||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.667
73811537|NCT00715104|147172970|SUPERIORITY_OR_OTHER|||||||0.191|TWO_SIDED|||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.191
73811538|NCT00715104|147172970|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED|||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.699
73811539|NCT00715104|147172971|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED|||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.086
73811540|NCT00715104|147172971|SUPERIORITY_OR_OTHER|||||||0.432|TWO_SIDED|||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.432
73811541|NCT00715104|147172971|SUPERIORITY_OR_OTHER|||||||0.249|TWO_SIDED|||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.249
73811542|NCT00715104|147172972|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||0.950
73811543|NCT00715104|147172973|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||0.048
73811544|NCT02059434|147172975|SUPERIORITY_OR_OTHER||Least squares mean difference|0.104|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.06|0.149||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates||0.149|0.060|<0.0001
73811545|NCT02059434|147172975|SUPERIORITY_OR_OTHER||Least squares mean difference|0.178|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.133|0.223||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates||0.223|0.133|<0.0001
73811546|NCT00771264|147172982|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|Mean values were analyzed for significant change using a 2-sided paired t-test and proportions were analyzed using chi-square methodology.||Mean values were analyzed for significant change using a 2-sided paired t test and proportions were analyzed using chi-square methodology. Median values were analyzed using a Wilcoxon signed rank test with p\<0.05 considered statistically significant. A sample size estimate of 214 subjects, 107 per arm, was calculated using a 2-sided Fisher's exact binomial test based on an estimated 60% responder rate in the PTNS group and a 40% in the sham group with a 5% significance level and 80% power.||||0.05
73811547|NCT02928770|147172987|OTHER|||||||0.0559|||||||t-test, 2 sided|Comparison between baseline and experimental (Nastent) conditions||||||0.0559
73811548|NCT01892085|147173055|SUPERIORITY|||||||0.015|||||||Marginalized two part model|||||||0.015
73811549|NCT01892085|147173055|SUPERIORITY|||||||0.339|||||||Marginalized two part model|||||||0.339
73811550|NCT01892085|147173056|SUPERIORITY|||||||0.024|||||||Marginalized two part model|||||||0.024
73811551|NCT01892085|147173056|SUPERIORITY|||||||0.317|||||||Marginalized two part model|||||||0.317
73811552|NCT01892085|147173057|SUPERIORITY|||||||0.031|||||||Marginalized two part model|||||||0.031
73811553|NCT01892085|147173057|SUPERIORITY|||||||0.298|||||||Marginalized two part model|||||||0.298
73811554|NCT01892085|147173058|SUPERIORITY|||||||0.05|||||||Marginalized two part model|||||||0.05
73896282|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.28|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|90.0|-58.53|-42.04||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-42.04|-58.53|<0.001
73811555|NCT01892085|147173058|SUPERIORITY|||||||0.27|||||||Marginalized 2 part model|||||||0.27
73811556|NCT01892085|147173059|SUPERIORITY|||||||0.069|||||||Marginalized two part model|||||||0.069
73811557|NCT01892085|147173059|SUPERIORITY|||||||0.244|||||||Marginalized two part model|||||||0.244
73811558|NCT01892085|147173060|SUPERIORITY|||||||0.094|||||||Marginalized two part model|||||||0.094
73811559|NCT01892085|147173060|SUPERIORITY|||||||0.235|||||||Marginalized 2 part model|||||||0.235
73811560|NCT01892085|147173061|SUPERIORITY|||||||0.123|||||||Marginalized two part model|||||||0.123
73811561|NCT01892085|147173061|SUPERIORITY|||||||0.21|||||||Marginalized two part model|||||||0.210
73811562|NCT01892085|147173062|SUPERIORITY|||||||0.143|||||||Marginalized two part model|||||||0.143
73811563|NCT01892085|147173062|SUPERIORITY|||||||0.196|||||||Marginalized two part model|||||||0.196
73811564|NCT01892085|147173063|SUPERIORITY|||||||0.185|||||||Marginalized two part model|||||||0.185
73811565|NCT01892085|147173063|SUPERIORITY|||||||0.183|||||||Marginalized two part model|||||||0.183
73811566|NCT01892085|147173064|SUPERIORITY|||||||0.229|||||||Marginalized two part model|||||||0.229
73811567|NCT01892085|147173064|SUPERIORITY|||||||0.17|||||||Marginalized two part model|||||||0.170
73811568|NCT01892085|147173065|SUPERIORITY|||||||0.314|||||||Marginalized two part model|||||||0.314
73811569|NCT01892085|147173065|SUPERIORITY|||||||0.162|||||||Marginalized two part model|||||||0.162
73811570|NCT01892085|147173066|SUPERIORITY|||||||0.377|||||||Marginalized two part model|||||||0.377
73811571|NCT01892085|147173066|SUPERIORITY|||||||0.149|||||||Marginalized two part model|||||||0.149
73811572|NCT01892085|147173067|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
73811573|NCT01892085|147173068|SUPERIORITY|||||||0.82|||||||ANOVA|||||||0.82
73811574|NCT01892085|147173069|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||00.22
73811575|NCT01892085|147173070|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
73811576|NCT01892085|147173071|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
73811577|NCT01892085|147173072|SUPERIORITY|||||||0.77|||||||Chi-squared|||||||0.77
73811578|NCT01892085|147173073|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
73811579|NCT01892085|147173074|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
73811580|NCT01892085|147173075|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
73811581|NCT01629823|147173076|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.51|TWO_SIDED|95.0|0.44|1.5||Comparison of 5cm group to control. No adjustment for multiple comparisons.|Regression, Linear|||Both the 5 and 10cm groups were compared to the control group, \<1cm H₂O||1.50|0.44|0.51
73811582|NCT01629823|147173076|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.57|TWO_SIDED|95.0|0.47|1.52|||Regression, Linear|||||1.52|0.47|0.57
73811583|NCT00550862|147173101|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals.||||<0.0001
73896283|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.07|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|90.0|-91.32|-74.83||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-74.83|-91.32|<0.001
73811584|NCT00550862|147173101|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals.||||<0.0001
73811585|NCT00550862|147173101|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals||||<0.0001
73811586|NCT00550862|147173102|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73811587|NCT00550862|147173103|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0005||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0005
73811588|NCT01683422|147173139|SUPERIORITY|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||||0.1|||||||t-test, 1 sided|||In the RTOG 9812 (NCT00003591) for unresectable pancreatic cancer, a one-year survival rate of 43% was observed. There were 109 analyzable patients on NCT00003591 with 61 still at risk for death at one year. Using the method of Dixon and Simon, a sample size of 39 analyzable patients followed over 12 months will ensure at least 90% probability of detecting a minimum of 17% improvement in the one-year survival rate compared to NCT00003591 at the 0.10 significance level (with a one-sided test).||||0.1
73811589|NCT01393132|147173150|SUPERIORITY_OR_OTHER|||||||0.0108|TWO_SIDED||||||t-test, 2 sided|||Comparison of fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0108
73811590|NCT01393132|147173151|SUPERIORITY_OR_OTHER|||||||0.0141|TWO_SIDED||||||t-test, 2 sided|||Comparison of Ocular Discomfort Index score between the placebo and Thymosin beta 4 groups||||0.0141
73811591|NCT01393132|147173152|SUPERIORITY_OR_OTHER|||||||0.0162|TWO_SIDED||||||t-test, 2 sided|||Comparison of Tear Film Break up Time between the placebo and Thymosin beta 4 groups.||||0.0162
73811592|NCT02003963|147173154|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
73811594|NCT00819780|147173221|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.871||||0.3531|TWO_SIDED|95.0|0.651|1.166|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.166|0.651|0.3531
73811595|NCT00819780|147173222|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.723||||0.1386|TWO_SIDED|95.0|0.47|1.111|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.111|0.470|0.1386
73811596|NCT00819780|147173223|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.5497|TWO_SIDED|95.0|0.72|1.95|||Stratified exact test|Stratified by prior adjuvant oxaliplatin therapy|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||1.95|0.72|0.5497
73811597|NCT00819780|147173225|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.874||||0.3861|TWO_SIDED|95.0|0.645|1.185|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.185|0.645|0.3861
73811598|NCT00819780|147173228|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.651||||0.0286|TWO_SIDED|95.0|0.444|0.956|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.956|0.444|0.0286
73811599|NCT00819780|147173229|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.579||||0.0083|TWO_SIDED|95.0|0.386|0.869|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.869|0.386|0.0083
73811600|NCT00819780|147173230|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.606||||0.0934|TWO_SIDED|95.0|0.337|1.088|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant Oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.088|0.337|0.0934
73811601|NCT00819780|147173231|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.465||||0.0235|TWO_SIDED|95.0|0.239|0.902|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.902|0.239|0.0235
73811602|NCT00819780|147173232|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.9426|TWO_SIDED|95.0|0.55|2.12|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||2.12|0.55|0.9426
73811603|NCT00819780|147173233|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.52|2.15|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||2.15|0.52|1.0000
73811604|NCT02832375|147173248|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.577|-0.319|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|H0= no difference between experimental dentifrice and control dentifrice H1= a difference between experimental dentifrice and control dentifrice||-0.319|-0.577|<0.0001
73811605|NCT06350461|147173251|NON_INFERIORITY|The non-inferiority margin is -3.|Median Difference (Final Values)|-0.324|||<|0.0001|TWO_SIDED|95.0|-1.3|0.6||One-sided test for non-inferiority|ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population.||0.6|-1.3|<0.0001
73811606|NCT06350461|147173252|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.733|TWO_SIDED|95.0|-0.4|0.4|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue|||0.4|-0.4|0.733
73811607|NCT06350461|147173253|SUPERIORITY||Mean Difference (Final Values)|-1.52||||0.226|TWO_SIDED|95.0|-4.1|0.9|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.9|-4.1|0.226
73811608|NCT06350461|147173254|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.857|TWO_SIDED|95.0|-1.8|2.1|||ANOVA|Adjusted for four dichotomous randomization strata|Direction of the difference is Discontinue - Continue|||2.1|-1.8|0.857
73811609|NCT06350461|147173255|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.16|TWO_SIDED|95.0|-0.25|1.54|||t-test, 2 sided||Direction of the difference is Discontinue - Continue|||1.54|-0.25|0.16
73811610|NCT06350461|147173256|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.56|TWO_SIDED|95.0|-1.04|0.57|||t-test, 2 sided||Direction of the difference is Discontinue - Continue|||0.57|-1.04|0.56
73811611|NCT06350461|147173257|SUPERIORITY||Difference in % Participants|1.1||||0.653|TWO_SIDED|95.0|-3.7|6.1|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants initiating acute antibiotics is the same in the Discontinue and Continue arms||6.1|-3.7|0.653
73811612|NCT06350461|147173258|SUPERIORITY||Difference in % Participants|0.5||||0.622|TWO_SIDED|95.0|-2.0|3.4|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one hospitalization is the same in Discontinue and Continue arms.||3.4|-2.0|0.622
73811613|NCT06350461|147173259|SUPERIORITY||Difference in % Participants|-1.1||||0.623|TWO_SIDED|95.0|-4.1|1.6|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one protocol-defined pulmonary exacerbation is the same in Discontinue and Continue arms.||1.6|-4.1|0.623
73811614|NCT06350461|147173260|SUPERIORITY||Difference in % Participants|11.7||||0.0165|TWO_SIDED|95.0|2.4|20.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one AE is the same in Discontinue and Continue arms.||20.7|2.4|0.0165
73811615|NCT06350461|147173261|SUPERIORITY||Rate Ratio|1.29||||0.0958|TWO_SIDED|95.0|0.96|1.74|||Poisson Regression|||Rate ratio, confidence interval, and p-value calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the HS-discontinue and HS-continue arms are 1135.7 and 1163.9 weeks, respectively. Ratio is Discontinue / Continue.||1.74|0.96|0.0958
73811616|NCT06350461|147173262|SUPERIORITY||Difference in % Participants|2.17||||0.1215|TWO_SIDED|95.0|-0.7|5.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.7|-0.7|0.1215
73811617|NCT00084318|147173263|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.05|TWO_SIDED|95.0|0.54|1.06|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method. \[RTOG = Radiation Therapy Oncology Group\]||1.06|0.54|0.05
73811618|NCT00084318|147173263|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.01|TWO_SIDED|95.0|0.5|0.96|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method.||0.96|0.50|0.01
73811619|NCT00084318|147173264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.04|TWO_SIDED|95.0|0.5|1.03|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]||1.03|0.5|0.04
73811620|NCT00084318|147173264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.001|TWO_SIDED|95.0|0.39|0.82|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model.||0.82|0.39|0.001
73811621|NCT00084318|147173268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.66|TWO_SIDED|95.0|0.63|1.76|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]||1.76|0.63|0.66
73811622|NCT00084318|147173268|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.86|TWO_SIDED|95.0|0.72|1.87|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model.||1.87|0.72|0.86
73811623|NCT03301740|147173274|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.5|TWO_SIDED|95.0|0.8|1.7||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in intradialytic hypotension between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.7|0.8|0.5
73811624|NCT03301740|147173275|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-2.8||||0.2|TWO_SIDED|95.0|-6.9|1.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T change between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.||1.4|-6.9|0.2
73811625|NCT03301740|147173276|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.5||||0.1|TWO_SIDED|95.0|0.2|1.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T rise between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.3|0.2|0.1
73811626|NCT03301740|147173277|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Mean Difference (Final Values)|-0.8||||0.2|TWO_SIDED|95.0|-2.0|0.5||Statistically significant p-value is \<0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in left ventricular GLS change between UF profiling and conventional HD. Wilcoxon (Mann-Whitney) tests were performed assessing the difference of the endpoint between the 2 treatment groups.||0.5|-2.0|0.2
73896284|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-94.51|STANDARD_ERROR_OF_MEAN|5.08|<|0.001|TWO_SIDED|90.0|-102.92|-86.1||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-86.10|-102.92|<0.001
73896285|NCT01375075|147325959|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.68|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|90.0|-76.2|-59.16||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-59.16|-76.20|<0.001
73811627|NCT03301740|147173278|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-0.2||||0.9|TWO_SIDED|95.0|-2.0|1.7||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in nadir systolic BP between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.||1.7|-2.0|0.9
73896286|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|1.38|2.21||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.21|1.38|<0.001
73811628|NCT03301740|147173279|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.8|TWO_SIDED|95.0|0.7|1.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in failed target weight achievement between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.3|0.7|0.8
73811629|NCT03301740|147173280|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.9|TWO_SIDED|95.0|0.4|2.1||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important cramping between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.1|0.4|0.9
73811630|NCT03301740|147173281|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.7||||0.5|TWO_SIDED|95.0|0.2|2.2||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important nausea/upset stomach between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.2|0.2|0.5
73811631|NCT03301740|147173282|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.1|16.0|||Mixed Models Analysis|||Null hypothesis = no difference in clinically important Vomiting/throwing up score between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||16.0|0.1|1.0
73811632|NCT03301740|147173283|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.2||||0.04|TWO_SIDED|95.0|0.1|0.9||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important dizziness/lightheadedness between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||0.9|0.1|0.04
73811633|NCT03301740|147173284|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|3.1||||0.3|TWO_SIDED|95.0|0.3|32.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important racing heart/heart palpitations between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||32.4|0.3|0.3
73811634|NCT03301740|147173285|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.2|6.0||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important chest pain between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.0|0.2|1.0
73811635|NCT03301740|147173286|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.3||||0.7|TWO_SIDED|95.0|0.3|6.5||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important shortness of breath between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.5|0.3|0.7
73811636|NCT03301740|147173287|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.2|TWO_SIDED|95.0|0.3|1.2||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important thirst/dry mouth between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.2|0.3|0.2
73896287|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|2.65|3.48||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.48|2.65|<0.001
73811637|NCT03301740|147173288|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.9||||0.8|TWO_SIDED|95.0|0.4|2.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important headache between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.3|0.4|0.8
73811638|NCT03301740|147173289|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|2.8||||0.02|TWO_SIDED|95.0|1.2|6.6||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important itching between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.6|1.2|0.02
73811639|NCT03301740|147173290|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.7|TWO_SIDED|95.0|0.5|2.6||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important restless legs/difficulty keeping legs still between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.6|0.5|0.7
73811640|NCT03301740|147173291|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.5|TWO_SIDED|95.0|0.2|2.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important tingling/feeling of pins and needles between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.4|0.2|0.5
73811641|NCT01037127|147173292|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|14.1|37.8|||||The estimated value reflects the percentage of particpants with CR and PR.|||37.8|14.1|
73811642|NCT01037127|147173293|SUPERIORITY_OR_OTHER||percentage of participants|17.0|||||TWO_SIDED|95.0|2.1|48.4|||||The estimated value reflects the percentage of particpants with CR and PR.|||48.4|2.1|
73811643|NCT01037127|147173293|SUPERIORITY_OR_OTHER||percentage of participants|27.0|||||TWO_SIDED|95.0|14.6|41.9|||||The estimated value reflects the percentage of particpants with CR and PR.|||41.9|14.6|
73811644|NCT01037127|147173293|SUPERIORITY_OR_OTHER||percentage of participants|26.0|||||TWO_SIDED|95.0|14.3|41.4|||||The estimated value reflects the percentage of particpants with CR and PR.|||41.4|14.3|
73811645|NCT01037127|147173293|SUPERIORITY_OR_OTHER||percentage of participants|28.0|||||TWO_SIDED|95.0|14.2|45.2|||||The estimated value reflects the percentage of particpants with CR and PR.|||45.2|14.2|
73811646|NCT01037127|147173294|SUPERIORITY_OR_OTHER||percentage of participants|20.0||||||95.0|7.7|38.6|||||The estimated value reflects the percentage of particpants with CR and PR.|||38.6|7.7|
73811647|NCT02584998|147173306|OTHER||||||<|0.001|||||||Chi-squared|||In our power and sample size analysis, we assumed 15% screening rate in usual care, 25% with invitation, and 40% with mailed-FIT. A sample size of 500 (250/arm) will give 80% power for UC vs. screening invitation-reminder, and 152/arm will give a power of 80% for the screening invitation-reminder vs. mailed-FIT. Accounting for the possibility that up to 20% of participants could be ineligible post-randomization, we concluded that we should enroll 783 patients, 261 per arm, for this trial.||||<0.001
73811648|NCT02847182|147173324|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.83|TWO_SIDED|95.0|-1.58|3.86|||t-test, 2 sided|||Null hypothesis: The mean of the 6-month change in VABS-II Socialization Subscale Standard Score is the same for the Cord Blood and Placebo groups.||3.86|-1.58|0.83
73811649|NCT04216589|147173402|OTHER|This was a single arm trial.|Mean Difference (Net)|-4.24|STANDARD_DEVIATION|4.05|<|0.001|TWO_SIDED|95.0|-5.41|-3.06|||Regression, Linear|||The study was powered to detect an absolute IHTG change of -5% assuming a null change of 0%, a standard deviation of absolute IHTG change of 9%, and 37 evaluable participants.||-3.06|-5.41|<0.001
73811650|NCT04216589|147173403|OTHER|This was a single arm trial.|Mean Difference (Net)|-31.33|STANDARD_DEVIATION|26.5|<|0.001|TWO_SIDED|95.0|-39.04|-23.62||No adjustment for multiple comparisons|Regression, Linear|||||-23.62|-39.04|<0.001
73811651|NCT04216589|147173407|OTHER|This was a single arm trial.|Mean Difference (Net)|-2.77|STANDARD_DEVIATION|2.05|<|0.001|TWO_SIDED|95.0|-3.36|-2.17||Not adjusted for multiple comparisons.|Regression, Linear|||||-2.17|-3.36|<0.001
73811652|NCT04216589|147173408|OTHER|This was a single arm trial.|Mean Difference (Net)|-2.15|STANDARD_DEVIATION|1.38|<|0.001|TWO_SIDED|95.0|-2.55|-1.75||Not adjusted for multiple comparisons|Regression, Linear|||||-1.75|-2.55|<0.001
73811653|NCT04216589|147173409|OTHER|This was a single arm trial.|Mean Difference (Net)|-7.8|STANDARD_DEVIATION|5.77|<|0.001|TWO_SIDED|95.0|-9.48|-6.13||Not adjusted for multiple comparisons|Regression, Linear|||||-6.13|-9.48|<0.001
73811654|NCT04216589|147173410|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.16|STANDARD_DEVIATION|3.96|<|0.001|TWO_SIDED|95.0|-7.3|-5.03||Not adjusted for multiple comparisons|Regression, Linear|||||-5.03|-7.30|<0.001
73896288|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|3.46|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|3.04|3.88||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.88|3.04|<0.001
73811655|NCT04216589|147173411|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.66|STANDARD_DEVIATION|6.47|<|0.001|TWO_SIDED|95.0|-8.54|-4.78||Not adjusted for multiple comparisons|Regression, Linear|||||-4.78|-8.54|<0.001
73811656|NCT04216589|147173412|OTHER|This was a single arm trial.|Mean Difference (Net)|-5.53|STANDARD_DEVIATION|5.3|<|0.001|TWO_SIDED|95.0|-7.07|-3.99||Not adjusted for multiple comparisons|Regression, Linear|||||-3.99|-7.07|<0.001
73811657|NCT04216589|147173413|OTHER|This was a single arm trial.|Mean Difference (Net)|-1.46|STANDARD_DEVIATION|5.82||0.092|TWO_SIDED|95.0|-3.17|0.25||Not adjusted for multiple comparisons|Regression, Linear|||||0.25|-3.17|0.092
73811658|NCT04216589|147173415|OTHER|This was a single arm trial.|Mean Difference (Net)|-0.25|STANDARD_DEVIATION|0.259|<|0.001|TWO_SIDED|95.0|-0.32|-0.17||Not adjusted for multiple comparisons|Regression, Linear|||||-0.17|-0.32|< 0.001
73811659|NCT04216589|147173416|OTHER|This was a single arm trial.|Mean Difference (Net)|-9.9|STANDARD_DEVIATION|16.6|<|0.001|TWO_SIDED|95.0|-14.7|-5.09||Not adjusted for multiple comparisons|Regression, Linear|||||-5.09|-14.70|<0.001
73811660|NCT04216589|147173417|OTHER|This was a single arm trial.|Mean Difference (Net)|-8.87|STANDARD_DEVIATION|11.5|<|0.001|TWO_SIDED|95.0|-12.26|-5.48||Not adjusted for multiple comparisons|Regression, Linear|||||-5.48|-12.26|<0.001
73811661|NCT04216589|147173418|OTHER|This was a single arm trial.|Mean Difference (Net)|-3.98|STANDARD_DEVIATION|23.1||0.25|TWO_SIDED|95.0|-10.84|2.89||Not adjusted for multiple comparisons|Regression, Linear|||||2.89|-10.84|0.25
73811662|NCT04216589|147173419|OTHER|This was a single arm trial.|Mean Difference (Net)|-11.93|STANDARD_DEVIATION|26.4||0.004|TWO_SIDED|95.0|-19.79|-4.08||Not adjusted for multiple comparisons|Regression, Linear|||||-4.08|-19.79|0.004
73811663|NCT04216589|147173420|OTHER|This was a single arm trial.|Mean Difference (Net)|-1.04|STANDARD_DEVIATION|20.5||0.73|TWO_SIDED|95.0|-7.14|5.05||Not adjusted for multiple comparisons|Regression, Linear|||||5.05|-7.14|0.73
73811664|NCT04216589|147173421|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.91|STANDARD_DEVIATION|23.1||0.051|TWO_SIDED|95.0|-13.85|0.03||Not adjusted for multiple comparisons|Regression, Linear|||||0.03|-13.85|0.051
73811665|NCT04216589|147173422|OTHER|This was a single arm trial.|Mean Difference (Net)|2.04|STANDARD_DEVIATION|6.96||0.053|TWO_SIDED|95.0|-0.02|4.11||Not adjusted for multiple comparisons|Regression, Linear|||||4.11|-0.02|0.053
73811666|NCT04216589|147173423|OTHER|This was a single arm trial.|Mean Difference (Net)|-0.78|STANDARD_DEVIATION|6.66||0.43|TWO_SIDED|95.0|-2.76|1.2||Not adjusted for multiple comparisons|Regression, Linear|||||1.20|-2.76|0.43
73811667|NCT04216589|147173424|OTHER|This was a single arm trial.|Mean Difference (Net)|-26.78|STANDARD_DEVIATION|64.8||0.007|TWO_SIDED|95.0|-46.04|-7.53||Not adjusted for multiple comparisons|Regression, Linear|||||-7.53|-46.04|0.007
73811668|NCT04216589|147173425|OTHER|This was a single arm trial.|Mean Difference (Net)|-18.65|STANDARD_DEVIATION|49.3||0.014|TWO_SIDED|95.0|-33.29|-4.01||Not adjusted for multiple comparisons|Regression, Linear|||||-4.01|-33.29|0.014
73811669|NCT04216589|147173426|OTHER|This was a single arm trial.|Risk Ratio (RR)|0.72||||0.016|TWO_SIDED|95.0|0.55|0.94||Not adjusted for multiple comparisons.|GEE model for repeated binary outcomes|The GEE model used a log link and an unstructured correlation.|The risk ratio is comparing the estimated risk at Week 12 (0.55; 95% CI: 0.43, 0.72) to estimated risk at Baseline (0.77; 95% CI: 0.67, 0.90).|Comparison between Baseline and Week 12.||0.94|0.55|0.016
73811670|NCT04216589|147173426|OTHER|This was a single arm trial.|Risk Ratio (RR)|0.75||||0.033|TWO_SIDED|95.0|0.58|0.98||Not adjusted for multiple comparisons.|GEE model for repeated binary outcomes|The GEE model used a log link and an unstructured correlation.|The risk ratio is comparing the estimated risk at Week 24 (0.58; 95% CI: 0.46, 0.74) to estimated risk at Baseline (0.77; 95% CI: 0.67, 0.90).|Comparison between Baseline and Week 24.||0.98|0.58|0.033
73896289|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|1.81|2.63||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.63|1.81|<0.001
73896290|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.4|2.36||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.36|1.40|<0.001
73811671|NCT03191864|147173435|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
73811672|NCT03191864|147173435|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73811673|NCT03191864|147173435|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73811674|NCT03191864|147173435|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73811675|NCT03191864|147173437|OTHER||Mean Difference (Final Values)|-1.28||||0.02|TWO_SIDED|90.0|-2.29|-0.26|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-0.26|-2.29|0.020
73811676|NCT03191864|147173437|OTHER||Mean Difference (Final Values)|-2.08|||<|0.001|TWO_SIDED|90.0|-3.07|-1.1|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-1.10|-3.07|<0.001
73811677|NCT03191864|147173437|OTHER||Mean Difference (Final Values)|-2.25|||<|0.001|TWO_SIDED|90.0|-3.23|-1.26|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-1.26|-3.23|<0.001
73811678|NCT03191864|147173437|OTHER||Mean Difference (Final Values)|-1.59||||0.005|TWO_SIDED|90.0|-2.59|-0.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-0.59|-2.59|0.005
73811679|NCT03191864|147173439|OTHER||Mean Difference (Final Values)|-1.19||||0.067|TWO_SIDED|90.0|-2.49|0.12|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||0.12|-2.49|0.067
73811680|NCT03191864|147173439|OTHER||Mean Difference (Final Values)|0.34||||0.672|TWO_SIDED|90.0|-0.91|1.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||1.59|-0.91|0.672
73811681|NCT03191864|147173439|OTHER||Mean Difference (Final Values)|-1.28||||0.048|TWO_SIDED|90.0|-2.55|-0.01|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||-0.01|-2.55|0.048
73811682|NCT03191864|147173439|OTHER||Mean Difference (Final Values)|0.31||||0.653|TWO_SIDED|90.0|-0.98|1.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||1.59|-0.98|0.653
73811683|NCT03191864|147173441|SUPERIORITY||Mean Difference (Final Values)|-8.81||||0.079|TWO_SIDED|90.0|-19.06|1.45|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||1.45|-19.06|0.079
73811684|NCT03191864|147173441|SUPERIORITY||Mean Difference (Final Values)|-5.18||||0.195|TWO_SIDED|90.0|-15.14|4.78|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||4.78|-15.14|0.195
73811685|NCT03191864|147173441|SUPERIORITY||Mean Difference (Final Values)|-12.56||||0.02|TWO_SIDED|90.0|-22.55|-2.58|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||-2.58|-22.55|0.020
73811686|NCT03191864|147173441|SUPERIORITY||Mean Difference (Final Values)|-10.61||||0.043|TWO_SIDED|90.0|-20.74|-0.48|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||-0.48|-20.74|0.043
73811687|NCT03191864|147173442|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.459|TWO_SIDED|90.0|-3.49|3.08|||ANCOVA|||VDQ Score Change from Baseline Week 12||3.08|-3.49|0.459
73811688|NCT03191864|147173442|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.617|TWO_SIDED|90.0|-2.65|3.8|||ANCOVA|||VDQ Score Change from Baseline Week 12||3.80|-2.65|0.617
73811689|NCT03191864|147173442|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.167|TWO_SIDED|90.0|-5.07|1.33|||ANCOVA|||VDQ Score Change from Baseline Week 12||1.33|-5.07|0.167
73811690|NCT03191864|147173442|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.373|TWO_SIDED|90.0|-3.88|2.61|||ANCOVA|||VDQ Score Change from Baseline Week 12||2.61|-3.88|0.373
73811691|NCT03191864|147173442|SUPERIORITY||Mean Difference (Final Values)|-1.66||||0.203|TWO_SIDED|90.0|-4.96|1.64|||ANCOVA|||AMS Score Change from Baseline Week 12||1.64|-4.96|0.203
73811692|NCT03191864|147173442|SUPERIORITY||Mean Difference (Final Values)|-4.33||||0.014|TWO_SIDED|90.0|-7.54|-1.13|||ANCOVA|||AMS Score Change from Baseline Week 12||-1.13|-7.54|0.014
73811693|NCT03191864|147173442|SUPERIORITY||Mean Difference (Final Values)|-3.02||||0.061|TWO_SIDED|90.0|-6.23|0.2|||ANCOVA|||AMS Score Change from Baseline Week 12||0.20|-6.23|0.061
73896291|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|2.99|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|2.51|3.47||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.47|2.51|<0.001
73811694|NCT03191864|147173442|SUPERIORITY||Mean Difference (Final Values)|-2.57||||0.097|TWO_SIDED|90.0|-5.83|0.69|||ANCOVA|||AMS Score Change from Baseline Week 12||0.69|-5.83|0.097
73811695|NCT01047332|147173467|OTHER|||||||0.53|||||||Log Rank|||||||0.530
73811696|NCT01047332|147173468|OTHER|||||||0.997|||||||Log Rank|||||||0.997
73811697|NCT03521817|147173473|OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.14|<|0.231|TWO_SIDED||||||t-test, 2 sided|||||||<0.231
73811698|NCT01752634|147173525|SUPERIORITY||Odds Ratio (OR)|2.32||||0.02|TWO_SIDED|95.0|1.14|4.73|||Regression, Logistic|||||4.73|1.14|0.0200
73811699|NCT01752634|147173525|SUPERIORITY||Odds Ratio (OR)|6.52|||<|1|TWO_SIDED|95.0|3.25|13.08|||Regression, Logistic|||||13.08|3.25|<0001
73811700|NCT01752634|147173525|SUPERIORITY||Odds Ratio (OR)|6.81|||<|0.0001|TWO_SIDED|95.0|3.42|13.56|||Regression, Logistic|||||13.56|3.42|<.0001
73811701|NCT01752634|147173526|SUPERIORITY||Odds Ratio (OR)|2.07||||0.165|TWO_SIDED|95.0|0.74|5.81|||Regression, Logistic|||||5.81|0.74|0.1650
73811702|NCT01752634|147173526|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0006|TWO_SIDED|95.0|2.12|15.34|||Regression, Logistic|||||15.34|2.12|0.0006
73811703|NCT01752634|147173526|SUPERIORITY||Odds Ratio (OR)|9.48|||<|0.0001|TWO_SIDED|95.0|3.33|27.0|||Regression, Logistic|||||27.00|3.33|<.0001
73811704|NCT01752634|147173527|SUPERIORITY||Odds Ratio (OR)|1.38||||0.6421|TWO_SIDED|95.0|0.36|5.36|||Regression, Logistic|||||5.36|0.36|0.6421
73811705|NCT01752634|147173527|SUPERIORITY||Odds Ratio (OR)|6.36||||0.0029|TWO_SIDED|95.0|1.89|21.47|||Regression, Logistic|||||21.47|1.89|0.0029
73811706|NCT01752634|147173527|SUPERIORITY||Odds Ratio (OR)|10.74||||0.0002|TWO_SIDED|95.0|3.13|36.84|||Regression, Logistic|||||36.84|3.13|0.0002
73811707|NCT01752634|147173528|SUPERIORITY||Mean Difference (Net)|-0.16||||0.3763|TWO_SIDED|95.0|-0.53|0.2|||Mixed Models Analysis|||||0.20|-0.53|0.3763
73811708|NCT01752634|147173528|SUPERIORITY||Mean Difference (Net)|-0.62||||0.0008|TWO_SIDED|95.0|-0.98|-0.26|||Mixed Models Analysis|||||-0.26|-0.98|0.0008
73811709|NCT01752634|147173528|SUPERIORITY||Mean Difference (Net)|-0.65||||0.0004|TWO_SIDED|95.0|-1.02|-0.29|||Mixed Models Analysis|||||-0.29|-1.02|0.0004
73811710|NCT01752634|147173529|SUPERIORITY||Mean Difference (Net)|2.42||||0.0482|TWO_SIDED|95.0|0.02|4.83|||Mixed Models Analysis|||||4.83|0.02|0.0482
73811711|NCT01752634|147173529|SUPERIORITY||Mean Difference (Net)|4.44||||0.0003|TWO_SIDED|95.0|2.05|6.83|||Mixed Models Analysis|||||6.83|2.05|0.0003
73811712|NCT01752634|147173529|SUPERIORITY||Mean Difference (Net)|5.3|||<|0.0001|TWO_SIDED|95.0|2.91|7.69|||Mixed Models Analysis|||||7.69|2.91|<0.0001
73811713|NCT01752634|147173530|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9195|TWO_SIDED|95.0|-0.16|0.15|||Mixed Models Analysis|||||0.15|-0.16|0.9195
73811714|NCT01752634|147173530|SUPERIORITY||Mean Difference (Net)|-0.17||||0.0278|TWO_SIDED|95.0|-0.32|-0.02|||Mixed Models Analysis|||||-0.02|-0.32|0.0278
73811715|NCT01752634|147173530|SUPERIORITY||Mean Difference (Net)|-0.25||||0.0013|TWO_SIDED|95.0|-0.4|-0.1|||Mixed Models Analysis|||||-0.10|-0.40|0.0013
73811716|NCT01752634|147173531|SUPERIORITY||Odds Ratio (OR)|2.91||||0.0245|TWO_SIDED|95.0|1.15|7.36|||Regression, Logistic|||||7.36|1.15|0.0245
73811717|NCT01752634|147173531|SUPERIORITY||Odds Ratio (OR)|7.54|||<|0.0001|TWO_SIDED|95.0|3.11|18.25|||Regression, Logistic|||||18.25|3.11|<.0001
73811718|NCT01752634|147173531|SUPERIORITY||Odds Ratio (OR)|7.15|||<|0.0001|TWO_SIDED|95.0|2.97|17.22|||Regression, Logistic|||||17.22|2.97|<.0001
73811719|NCT01752634|147173532|SUPERIORITY||Odds Ratio (OR)|0.51||||0.3149|TWO_SIDED|95.0|0.13|1.91|||Regression, Logistic|||||1.91|0.13|0.3149
73811720|NCT01752634|147173532|SUPERIORITY||Odds Ratio (OR)|0.16||||0.0056|TWO_SIDED|95.0|0.04|0.58|||Regression, Logistic|||||0.58|0.04|0.0056
73811721|NCT01752634|147173532|SUPERIORITY||Odds Ratio (OR)|0.14||||0.0021|TWO_SIDED|95.0|0.04|0.5|||Regression, Logistic|||||0.50|0.04|0.0021
73811722|NCT01752634|147173533|SUPERIORITY||Odds Ratio (OR)|0.58||||0.1678|TWO_SIDED|95.0|0.26|1.26|||Regression, Logistic|||||1.26|0.26|0.1678
73811723|NCT01752634|147173533|SUPERIORITY||Odds Ratio (OR)|0.36||||0.0108|TWO_SIDED|95.0|0.17|0.79|||Regression, Logistic|||||0.79|0.17|0.0108
73811724|NCT01752634|147173533|SUPERIORITY||Odds Ratio (OR)|0.29||||0.0025|TWO_SIDED|95.0|0.13|0.65|||Regression, Logistic|||||0.65|0.13|0.0025
73811725|NCT01196936|147173542|SUPERIORITY|||||||0.05||||||The calculated p-value is 0.05.|Mixed Models Analysis|||||||0.05
73811726|NCT01196936|147173543|SUPERIORITY|||||||0.0266|||||||Mixed Models Analysis|||||||0.0266
73811727|NCT01196936|147173544|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
73896292|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|90.0|3.42|4.41||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||4.41|3.42|<0.001
73896293|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.56|2.52||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.52|1.56|<0.001
73811728|NCT01196936|147173545|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
73811729|NCT01196936|147173546|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
73811730|NCT01196936|147173547|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||> 0.05
73896294|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.34|2.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.31|1.34|<0.001
73811731|NCT01196936|147173548|SUPERIORITY|||||||0.071|||||||Mixed Models Analysis|||||||0.071
73811732|NCT01196936|147173549|SUPERIORITY|||||||0.739|||||||Mixed Models Analysis|||||||0.739
73811733|NCT01196936|147173550|SUPERIORITY|||||||0.8315|||||||Mixed Models Analysis|||||||0.8315
73811734|NCT04599933|147173589|SUPERIORITY||Odds Ratio (OR)|2.916|||<|0.01|TWO_SIDED|95.0|1.663|5.113|||Regression, Logistic|||All treatment comparisons for primary and secondary endpoints related to BDCVA were conducted with a logistic regression model including fixed effects of baseline BDCVA at 40 cm as a covariate and treatment.||5.113|1.663|<0.01
73811735|NCT04599933|147173590|SUPERIORITY||Odds Ratio (OR)|3.035|||<|0.01|TWO_SIDED|95.0|1.736|5.305|||Regression, Logistic|||||5.305|1.736|<0.01
73811736|NCT04599933|147173591|SUPERIORITY||Odds Ratio (OR)|4.751|||<|0.01|TWO_SIDED|95.0|2.694|8.379|||Regression, Logistic|||||8.379|2.694|<0.01
73811737|NCT04599933|147173592|SUPERIORITY||Odds Ratio (OR)|3.422|||<|0.01|TWO_SIDED|95.0|1.923|6.09|||Regression, Logistic|||||6.090|1.923|<0.01
73811738|NCT05014815|147173641|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4698|TWO_SIDED|95.0|0.74|1.33||1-sided p-value|Log Rank|Stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|||1.33|0.74|0.4698
73811739|NCT05014815|147173642|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.47|1.26|||||The Mantel-Haenszel common OR and its 95% CI were estimated using a normal approximation of the log odds ratio and the Robins-Breslow-Greenland variance, stratified by PD-L1 expression and histology.|||1.26|0.47|
73811740|NCT05014815|147173644|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.67|1.34|||||The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|||1.34|0.67|
73811741|NCT02453282|147173652|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.036|TWO_SIDED|97.54|0.564|1.019||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.019|0.564|0.036
73811742|NCT02453282|147173652|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.202|TWO_SIDED|98.77|0.611|1.173||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.173|0.611|0.202
73811743|NCT02453282|147173653|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.705|TWO_SIDED|99.5|0.722|1.534||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.534|0.722|0.705
73811744|NCT02453282|147173654|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.523|TWO_SIDED|95.0|0.836|1.421||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.421|0.836|0.523
73896295|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|2.34|3.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.31|2.34|<0.001
73811745|NCT02453282|147173655|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.194|TWO_SIDED|95.0|0.725|1.067||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.067|0.725|0.194
73811746|NCT02453282|147173655|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.952|TWO_SIDED|95.0|0.834|1.213||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.213|0.834|0.952
73811747|NCT02453282|147173655|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.218|TWO_SIDED|95.0|0.931|1.371||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.371|0.931|0.218
73811748|NCT02453282|147173656|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.602|TWO_SIDED|95.0|0.812|1.128||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.128|0.812|0.602
73811749|NCT02453282|147173656|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.43|TWO_SIDED|95.0|0.794|1.103||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.103|0.794|0.430
73811750|NCT02453282|147173656|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.802|TWO_SIDED|95.0|0.828|1.157||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.157|0.828|0.802
73811751|NCT02453282|147173657|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.324|TWO_SIDED|95.0|0.667|1.143||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.143|0.667|0.324
73811752|NCT02453282|147173657|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.207|TWO_SIDED|95.0|0.911|1.541||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.541|0.911|0.207
73811753|NCT02453282|147173658|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.383|TWO_SIDED|95.0|0.894|1.339||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.339|0.894|0.383
73811754|NCT02453282|147173658|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.001|TWO_SIDED|95.0|1.136|1.678||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.678|1.136|0.001
73811755|NCT02453282|147173658|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.138|TWO_SIDED|95.0|0.954|1.403||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.403|0.954|0.138
73811756|NCT02453282|147173659|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.015|TWO_SIDED|95.0|1.043|1.475||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.475|1.043|0.015
73896296|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|3.24|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|90.0|2.74|3.73||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.73|2.74|<0.001
73811757|NCT02453282|147173659|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.01|TWO_SIDED|95.0|1.054|1.485||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.485|1.054|0.010
73811758|NCT02453282|147173659|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.984|TWO_SIDED|95.0|0.845|1.179||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.179|0.845|0.984
73811759|NCT02453282|147173660|SUPERIORITY||Odds Ratio (OR)|0.91||||0.698|TWO_SIDED|95.0|0.582|1.437||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.437|0.582|0.698
73811760|NCT02453282|147173660|SUPERIORITY||Odds Ratio (OR)|0.87||||0.534|TWO_SIDED|95.0|0.549|1.363||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.363|0.549|0.534
73811761|NCT02453282|147173660|SUPERIORITY||Odds Ratio (OR)|0.95||||0.82|TWO_SIDED|95.0|0.601|1.496||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.496|0.601|0.820
73811762|NCT02453282|147173661|SUPERIORITY||Odds Ratio (OR)|0.69||||0.05|TWO_SIDED|95.0|0.48|1.0||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.000|0.480|0.050
73811763|NCT02453282|147173661|SUPERIORITY||Odds Ratio (OR)|0.67||||0.029|TWO_SIDED|95.0|0.464|0.959||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||0.959|0.464|0.029
73811764|NCT02453282|147173661|SUPERIORITY||Odds Ratio (OR)|0.97||||0.887|TWO_SIDED|95.0|0.661|1.43||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.430|0.661|0.887
73811765|NCT02453282|147173662|SUPERIORITY||Odds Ratio (OR)|0.65||||0.012|TWO_SIDED|95.0|0.462|0.908||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||0.908|0.462|0.012
73811766|NCT02453282|147173662|SUPERIORITY||Odds Ratio (OR)|0.76||||0.093|TWO_SIDED|95.0|0.543|1.048||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.048|0.543|0.093
73811767|NCT02453282|147173662|SUPERIORITY||Odds Ratio (OR)|1.16||||0.406|TWO_SIDED|95.0|0.818|1.647||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.647|0.818|0.406
73896297|NCT01375075|147325960|SUPERIORITY_OR_OTHER||LS Mean Difference|2.14|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.65|2.63||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.63|1.65|<0.001
73896298|NCT01375075|147325961|SUPERIORITY_OR_OTHER||LS Mean Difference|74.23|STANDARD_ERROR_OF_MEAN|12.59|<|0.001|TWO_SIDED|90.0|53.38|95.07||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||95.07|53.38|<0.001
73896299|NCT01375075|147325961|SUPERIORITY_OR_OTHER||LS Mean Difference|115.36|STANDARD_ERROR_OF_MEAN|12.55|<|0.001|TWO_SIDED|90.0|94.58|136.14||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||136.14|94.58|<0.001
73811768|NCT02453282|147173669|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.03|TWO_SIDED|95.0|0.597|0.975||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||0.975|0.597|0.030
73811769|NCT02453282|147173669|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.045|TWO_SIDED|95.0|0.606|0.994||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||0.994|0.606|0.045
73811770|NCT02453282|147173670|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.255|TWO_SIDED|95.0|0.746|1.08||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.080|0.746|0.255
73811771|NCT02453282|147173670|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.534|TWO_SIDED|95.0|0.787|1.132||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.132|0.787|0.534
73811772|NCT02453282|147173671|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.663|TWO_SIDED|95.0|0.824|1.131||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.131|0.824|0.663
73811773|NCT02453282|147173671|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.103|TWO_SIDED|95.0|0.746|1.027||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.027|0.746|0.103
73811774|NCT01661933|147173689|SUPERIORITY_OR_OTHER|||||||0.693|TWO_SIDED||||||t-test, 2 sided|||||||0.693
73811775|NCT01661933|147173690|SUPERIORITY_OR_OTHER||||||=|0.837|TWO_SIDED||||||t-test, 2 sided|||||||=0.837
73811776|NCT01661933|147173691|SUPERIORITY_OR_OTHER||||||=|0.99|ONE_SIDED||||||Binomial distribution|||The null hypothesis was that irrespective of hookworm infection, GC-1g would result in a 2-point or more deterioration in the Marsh score. A binomial (yes=deterioration or no=no deterioration) distribution was applied to pre- and post-GC-1g paired biopsies.||||=0.99
73811777|NCT01661933|147173692|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Mixed effects model.|||||||=0.005
73811778|NCT02901275|147173709|SUPERIORITY|||||||0.61||||||No covariate or correction for multiple comparisons. a priori statistical threshold is p\<.05|Mixed Models Analysis|||||||0.61
73811779|NCT02901275|147173710|SUPERIORITY||||||<|0.0001||||||No covariates or correction for multiple comparisons. a priori threshold is p\<.05.|Mixed Models Analysis|||||||<.0001
73811780|NCT02901275|147173711|SUPERIORITY|||||||0.51||||||No covariate or correction for multiple comparisons. a priori threshold for significance is p\<.05|Mixed Models Analysis|||||||0.51
73811781|NCT02063178|147173712|SUPERIORITY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This randomized clinical trial was designed to have 90% power to detect a 4% weight loss percent difference at 12 months between the two study arms.||||<0.001
73896300|NCT01375075|147325961|SUPERIORITY_OR_OTHER||LS Mean Difference|135.57|STANDARD_ERROR_OF_MEAN|12.72|<|0.001|TWO_SIDED|90.0|114.5|156.63||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||156.63|114.50|<0.001
73811782|NCT02063178|147173713|OTHER|Correlation|||||<|0.0001|||||||Correlation|||The association between weight change percent and attendance was described using Spearman rank correlation.||||<0.0001
73811783|NCT02063178|147173714|OTHER||||||<|0.0001|||||||Correlation|||||||<0.0001
73811784|NCT02063178|147173715|OTHER||||||<|0.0001|||||||Correlation|||||||<0.0001
73811785|NCT01260272|147173729|SUPERIORITY_OR_OTHER||||||=|0.033||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.033
73811786|NCT01260272|147173730|SUPERIORITY_OR_OTHER||||||=|0.0468||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.0468
73811787|NCT01260272|147173731|SUPERIORITY_OR_OTHER||||||=|0.2114||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.2114
73811788|NCT01260272|147173732|SUPERIORITY_OR_OTHER||||||=|0.1727||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.1727
73811789|NCT01260272|147173733|SUPERIORITY_OR_OTHER||||||=|0.7498||||||Apriori threshold for statistical significance was \<=0.05|Wilcoxon (Mann-Whitney)|||||||=0.7498
73811790|NCT01260272|147173734|SUPERIORITY_OR_OTHER||||||=|0.2615||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.2615
73811791|NCT01260272|147173735|SUPERIORITY_OR_OTHER||||||=|0.6915||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.6915
73811792|NCT01260272|147173736|SUPERIORITY_OR_OTHER|||||||0.106||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||0.1060
73811793|NCT00435487|147173737|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-2.6||||||95.0|-8.59|3.4|||upper limit of 95% CI <= 10%||95% confidence interval (CI) is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||3.40|-8.59|
73811794|NCT00435487|147173737|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|1.25||||||95.0|-3.02|5.52|||upper limit of 95% CI <= 10%||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||5.52|-3.02|
73811795|NCT00435487|147173737|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-1.35||||||95.0|-8.62|5.93|||upper limit of 95% CI <= 10%||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death or Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||5.93|-8.62|
73811796|NCT00435487|147173738|SUPERIORITY_OR_OTHER||Difference in proportion|1.27||||1||95.0|-1.2|3.73|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||3.73|-1.20|1.0000
73811797|NCT00435487|147173739|SUPERIORITY_OR_OTHER||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||5.95|-6.05|1.0000
73811798|NCT00435487|147173740|SUPERIORITY_OR_OTHER||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||5.95|-6.05|1.0000
73811799|NCT03301844|147173745|SUPERIORITY|||||||0.071|||||||Chi-squared||||"Patient preference for one of the two treatments at Visit 3 was presented overall in terms of number and percentage of patients preferring the standard or the study treatment.~Patient preference was compared between the standard and the study treatment with a Chi-Square test for equal proportion."|||0.071
73811800|NCT03301844|147173746|OTHER|||||||0.7353|||||||Chi-squared||||"The incidence of all the treatment-emergent systemic Adverse Events recorded in the eCRF was presented overall at patient level; the incidence of all the treatment-emergent ocular Adverse Events recorded in eCRF was presented by treatment group at eye level.~Incidence of treatment-emergent ocular Adverse Events was compared between treatment groups by means of a Chi-square test."|||0.7353
73896301|NCT01375075|147325961|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.47|STANDARD_ERROR_OF_MEAN|4.85||0.002|TWO_SIDED|90.0|-23.5|-7.43||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-7.43|-23.50|0.002
73811801|NCT01267201|147173751|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|92.11|||||TWO_SIDED|90.0|88.23|96.15||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||96.15|88.23|
73811802|NCT01267201|147173751|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|90.22|||||TWO_SIDED|90.0|86.49|94.11||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||94.11|86.49|
73811803|NCT01267201|147173752|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|94.76|||||TWO_SIDED|90.0|88.06|101.98||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||101.98|88.06|
73811804|NCT01267201|147173752|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|83.89|||||TWO_SIDED|90.0|78.06|90.17||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||90.17|78.06|
73811805|NCT00501059|147173755|SUPERIORITY_OR_OTHER|||||||0.597|||||||Log Rank|||Primary efficacy analysis of time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant and the primary objective of the study will have been met if the 2-sided P value is ≤0.05.||||0.597
73811806|NCT00501059|147173756|SUPERIORITY_OR_OTHER|||||||0.6125|||||||Log Rank|||Statistics for time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.6125
73811807|NCT00501059|147173757|SUPERIORITY_OR_OTHER|||||||0.4505|||||||Log Rank|||Statistics for time to non-fatal MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.4505
73811808|NCT00501059|147173757|SUPERIORITY_OR_OTHER|||||||0.229|||||||Log Rank|||Statistics for time to total MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.229
73811809|NCT00501059|147173757|SUPERIORITY_OR_OTHER|||||||0.3947|||||||Log Rank|||Statistics for time to total non-fatal stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.3947
73811810|NCT00501059|147173757|SUPERIORITY_OR_OTHER|||||||0.5125|||||||Log Rank|||Statistics for time to total stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.5125
73811811|NCT00501059|147173758|SUPERIORITY_OR_OTHER|||||||0.9544|||||||Log Rank|||Analysis of time to all-cause mortality was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.9544
73811812|NCT00501059|147173758|SUPERIORITY_OR_OTHER|||||||0.4422|||||||Log Rank|||Analysis of time to the first occurrence of all cancers excluding non-melanoma skin cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.4422
73811813|NCT00501059|147173758|SUPERIORITY_OR_OTHER|||||||0.611|||||||Log Rank|||Analysis of time to the first occurence colon cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.611
73811814|NCT00501059|147173759|OTHER||Cox Proportional Hazard|0.99||||0.9459|TWO_SIDED|95.0|0.8|1.24|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.24|0.80|0.9459
73811815|NCT00501059|147173760|OTHER||Cox Proportional Hazard|0.85||||0.2325|TWO_SIDED|95.0|0.64|1.11|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.11|0.64|0.2325
73811816|NCT00501059|147173760|OTHER||Cox Proportional Hazard|1.12||||0.5072||95.0|0.8|1.55|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.55|0.80|0.5072
73896302|NCT01375075|147325961|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.37|STANDARD_ERROR_OF_MEAN|4.83|<|0.001|TWO_SIDED|90.0|-31.37|-15.38||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-15.38|-31.37|<0.001
73896303|NCT01375075|147325961|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.19|STANDARD_ERROR_OF_MEAN|4.91|<|0.001|TWO_SIDED|90.0|-30.32|-14.06||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-14.06|-30.32|<0.001
73896304|NCT01375075|147325961|SUPERIORITY_OR_OTHER||LS Mean Difference|103.25|STANDARD_ERROR_OF_MEAN|12.64|<|0.001|TWO_SIDED|90.0|82.32|124.18||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||124.18|82.32|<0.001
73896305|NCT01375075|147325961|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.63|STANDARD_ERROR_OF_MEAN|4.88||0.003|TWO_SIDED|90.0|-22.72|-6.55||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-6.55|-22.72|0.003
73896306|NCT03207035|147325992|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73811817|NCT00501059|147173760|OTHER||Cox Proportional Hazard|0.97||||0.901||95.0|0.62|1.52|||Log Rank|||Analysis of incidence of cardiovascular death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.52|0.62|0.9010
73811818|NCT00501059|147173760|OTHER||Cox Proportional Hazard|1.0||||0.9979|TWO_SIDED|95.0|0.54|1.86|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.86|0.54|0.9979
73896307|NCT03207035|147325993|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
73896308|NCT03207035|147325994|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
73811819|NCT00501059|147173760|OTHER||Cox Proportional Hazard|0.93||||0.7455|TWO_SIDED|95.0|0.61|1.42|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.42|0.61|0.7455
73811820|NCT00501059|147173762|OTHER||Cox Proportional Hazard|0.96||||0.6038|TWO_SIDED|95.0|0.81|1.13|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.13|0.81|0.6038
73811821|NCT00501059|147173762|OTHER||Cox Proportional Hazard|0.95||||0.619|TWO_SIDED|95.0|0.79|1.15|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.15|0.79|0.6190
73811822|NCT00501059|147173762|OTHER||Cox Proportional Hazard|0.9||||0.4562|TWO_SIDED|95.0|0.67|1.2|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.20|0.67|0.4562
73811823|NCT00501059|147173763|OTHER||Cox Proportional Hazard|0.81||||0.0756|TWO_SIDED|95.0|0.64|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.02|0.64|0.0756
73811824|NCT00501059|147173763|OTHER||Cox Proportional Hazard|0.79||||0.0661|TWO_SIDED|95.0|0.61|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.02|0.61|0.0661
73896309|NCT03207035|147325995|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
73896310|NCT03207035|147325996|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
73896311|NCT03207035|147325997|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
73896312|NCT03207035|147325998|OTHER|||||||0.53|||||||Chi-squared|||||||0.53
73896313|NCT03207035|147325999|OTHER|||||||0.48|||||||Chi-squared|||||||0.48
73811825|NCT00501059|147173763|OTHER||Cox Proportional Hazard|0.53||||0.0014|TWO_SIDED|95.0|0.36|0.79|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||0.79|0.36|0.0014
73811826|NCT00501059|147173763|OTHER||Cox Proportional Hazard|0.55||||0.0056|TWO_SIDED|95.0|0.36|0.84|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||0.84|0.36|0.0056
73811827|NCT00501059|147173763|OTHER||Cox Proportional Hazard|1.12||||0.6291||95.0|0.71|1.75|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.75|0.71|0.6291
73811828|NCT00501059|147173763|OTHER||Cox Proportional Hazard|1.03||||0.9161|TWO_SIDED|95.0|0.6|1.77|||Log Rank|||Analysis of incidence of CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.77|0.60|0.9161
73811829|NCT00501059|147173763|OTHER||Cox Proportional Hazard|0.75||||0.538||95.0|0.3|1.87|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.87|0.30|0.5380
73811830|NCT00501059|147173763|OTHER||Cox Proportional Hazard|1.03||||0.9181|TWO_SIDED|95.0|0.55|1.95|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.95|0.55|0.9181
73811831|NCT00501059|147173763|OTHER||Cox Proportional Hazard|1.1||||0.4796|TWO_SIDED|95.0|0.84|1.45|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.45|0.84|0.4796
73811832|NCT02719938|147173769|SUPERIORITY|||||||0.415|||||||t-test, 2 sided|||||||0.415
73811833|NCT02719938|147173770|SUPERIORITY|||||||0.521|||||||t-test, 2 sided|||||||0.521
73811834|NCT02719938|147173771|SUPERIORITY|||||||0.409|||||||t-test, 2 sided|||||||0.409
73811835|NCT02719938|147173772|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||0.019
73811836|NCT02719938|147173773|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73811837|NCT02719938|147173774|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73811838|NCT02719938|147173775|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||||||0.516
73811839|NCT00955968|147173776|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.54|TWO_SIDED|95.0|0.19|2.4||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||2.40|0.19|0.54
73811840|NCT00955968|147173777|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.66|TWO_SIDED|95.0|0.11|4.01||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||4.01|0.11|0.66
73811841|NCT00955968|147173779|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.44|TWO_SIDED|95.0|0.09|2.81||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||2.81|0.09|0.44
73811842|NCT00955968|147173780|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.79|TWO_SIDED|95.0|0.54|1.6||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||1.60|0.54|0.79
73811843|NCT00955968|147173781|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.71|TWO_SIDED|95.0|0.54|1.52||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||1.52|0.54|0.71
73811844|NCT00955968|147173782|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.42|0.8||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||0.80|0.42|<0.001
73811845|NCT00955968|147173783|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1|TWO_SIDED|95.0|0.72|1.03||5% alpha level and 2-sided test|Log Rank|||||1.03|0.72|0.10
73811846|NCT03559868|147173805|SUPERIORITY||||||<|0.01|||||||ANOVA|Ordinary one-way ANOVA Bartlett's test||For IL10||||<0.01
73811847|NCT00710684|147173833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.279|TWO_SIDED|95.0|-1.9|0.5|||mixed model for repeated measures (MMRM)|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15mg versus placebo at Week 24||0.5|-1.9|0.279
73811848|NCT00710684|147173833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.012|TWO_SIDED|95.0|-2.7|-0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35mg versus placebo at Week 24||-0.3|-2.7|0.012
73811849|NCT00710684|147173834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.711|TWO_SIDED|95.0|-0.4|0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||0.3|-0.4|0.711
73811850|NCT00710684|147173834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.462|TWO_SIDED|95.0|-0.5|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||0.2|-0.5|0.462
73811851|NCT00710684|147173835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.174|TWO_SIDED|95.0|-5.8|1.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||1.1|-5.8|0.174
73811852|NCT00710684|147173835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.776|TWO_SIDED|95.0|-3.6|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||2.7|-3.6|0.776
73811853|NCT00710684|147173836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.631|TWO_SIDED|95.0|-1.2|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||0.7|-1.2|0.631
73811854|NCT00710684|147173836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.006|TWO_SIDED|95.0|-2.2|-0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||-0.4|-2.2|0.006
73811855|NCT00710684|147173836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.947|TWO_SIDED|95.0|-1.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||1.2|-1.3|0.947
73811856|NCT00710684|147173836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.057|TWO_SIDED|95.0|-2.5|0.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||0.0|-2.5|0.057
73811857|NCT00710684|147173836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.925|TWO_SIDED|95.0|-1.6|1.5|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||1.5|-1.6|0.925
73811858|NCT00710684|147173836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.024|TWO_SIDED|95.0|-3.1|-0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||-0.2|-3.1|0.024
73811859|NCT00710684|147173837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.387|TWO_SIDED|95.0|-0.4|0.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||0.1|-0.4|0.387
73811860|NCT00710684|147173837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.018|TWO_SIDED|95.0|-0.5|-0.1|||MMRM|||SB-742457 35 mg versus placebo at Week 12||-0.1|-0.5|0.018
73811861|NCT00710684|147173837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.439|TWO_SIDED|95.0|-0.3|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||0.6|-0.3|0.439
73811862|NCT00710684|147173837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.336|TWO_SIDED|95.0|-0.6|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||0.2|-0.6|0.336
73811863|NCT00710684|147173837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.19|TWO_SIDED|95.0|-0.2|0.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||0.8|-0.2|0.190
73811864|NCT00710684|147173837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.787|TWO_SIDED|95.0|-0.5|0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||0.4|-0.5|0.787
73811865|NCT00710684|147173838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.337|TWO_SIDED|95.0|-4.0|1.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||1.4|-4.0|0.337
73811866|NCT00710684|147173838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.596|TWO_SIDED|95.0|-1.7|3.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||3.0|-1.7|0.596
73811867|NCT00710684|147173838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.634|TWO_SIDED|95.0|-4.4|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||2.7|-4.4|0.634
73811868|NCT00710684|147173838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1||||0.238|TWO_SIDED|95.0|-1.4|5.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||5.6|-1.4|0.238
73896314|NCT01252732|147326021|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|-2.7|||||TWO_SIDED|95.0|-7.5|2.0||||||||2.0|-7.5|
73811869|NCT00710684|147173838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.292|TWO_SIDED|95.0|-6.0|1.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||1.8|-6.0|0.292
73811870|NCT00710684|147173838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.161|TWO_SIDED|95.0|-1.0|6.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||6.2|-1.0|0.161
73811871|NCT00710684|147173839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.396|TWO_SIDED|95.0|-0.8|2.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||2.1|-0.8|0.396
73811872|NCT00710684|147173839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7||||0.019|TWO_SIDED|95.0|0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||3.2|0.3|0.019
73811873|NCT00710684|147173839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.11|TWO_SIDED|95.0|-0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||3.2|-0.3|0.110
73811874|NCT00710684|147173839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0||||0.024|TWO_SIDED|95.0|0.3|3.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||3.7|0.3|0.024
73811875|NCT00710684|147173839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.944|TWO_SIDED|95.0|-2.1|2.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo ate Week 36||2.0|-2.1|0.944
73811876|NCT00710684|147173839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.037|TWO_SIDED|95.0|0.1|3.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||3.8|0.1|0.037
73811877|NCT00710684|147173839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.705|TWO_SIDED|95.0|-1.9|2.9|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||2.9|-1.9|0.705
73811878|NCT00710684|147173839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.088|TWO_SIDED|95.0|-0.3|4.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||4.2|-0.3|0.088
73811879|NCT00710684|147173840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.962|TWO_SIDED|95.0|-0.6|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||0.6|-0.6|0.962
73811880|NCT00710684|147173840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.134|TWO_SIDED|95.0|-0.1|1.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||1.0|-0.1|0.134
73811881|NCT00710684|147173840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.782|TWO_SIDED|95.0|-1.0|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||0.7|-1.0|0.782
73811882|NCT00710684|147173840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.268|TWO_SIDED|95.0|-0.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||1.2|-0.3|0.268
73811883|NCT01254851|147173875|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|0.39||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.70
73811884|NCT04231396|147173881|SUPERIORITY||Mean Difference (Final Values)|0.1456||||0.037|TWO_SIDED|95.0|0.012|0.279|||t-test, 1 sided|||The SNR Loss scores computed the means per client and week (1-12), with a smoothing method: isotonic regression (isoreg, via R). The slopes (lsfit, via R) calculated of the smoothed means separately per client, per 7-9 weeks (early training weeks), and per 10-12 weeks (final training weeks). This created slope differences, per client.||.279|.012|.037
73811885|NCT00778102|147173890|SUPERIORITY_OR_OTHER||Difference in Resection Rate|12.3||||0.2707|TWO_SIDED|95.0|-11.0|35.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with R0, R1, or R2.||35.5|-11.0|0.2707
73811886|NCT00778102|147173893|SUPERIORITY_OR_OTHER||Difference in Response Rate|-4.8||||0.7817|TWO_SIDED|95.0|-43.0|33.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with complete or major histopathological response.||33.5|-43.0|0.7817
73811887|NCT00778102|147173900|SUPERIORITY_OR_OTHER||Difference in Response Rate (CR or PR)|18.9||||0.0612|TWO_SIDED|95.0|-2.1|40.0|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with confirmed best overall response of CR or PR.||40.0|-2.1|0.0612
73811888|NCT04676412|147173926|OTHER|Percent difference and 95% CI were calculated using Miettinen and Nurminen method with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).|Difference in percentage|-8.4||||0.79262|TWO_SIDED|95.0|-27.4|11.9|||Stratified Miettinen and Nurminen|One-sided p-value for testing. H0: difference in percentage =0 versus H1: difference in percentage \> 0||||11.9|-27.4|0.79262
73811889|NCT04676412|147173929|OTHER|Difference in LS means and 95% CI were calculated using the Constrained longitudinal data analysis (cLDA) model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in Least Square (LS) Means|-0.25||||0.9519|TWO_SIDED|95.0|-8.59|8.09|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||8.09|-8.59|0.9519
73811890|NCT04676412|147173930|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|8.81||||0.0628|TWO_SIDED|95.0|-0.49|18.11|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||18.11|-0.49|0.0628
73811891|NCT04676412|147173931|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|3.59||||0.3298|TWO_SIDED|95.0|-3.7|10.87|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||10.87|-3.70|0.3298
73811892|NCT04676412|147173932|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|-0.28||||0.9594|TWO_SIDED|95.0|-11.32|10.75|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||10.75|-11.32|0.9594
73811893|NCT04676412|147173933|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|-5.53||||0.162|TWO_SIDED|95.0|-13.37|2.31|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||2.31|-13.37|0.1620
73811894|NCT04676412|147173934|OTHER|HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.03||||0.9419|TWO_SIDED|95.0|0.47|2.26|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.26|0.47|0.9419
73811895|NCT04676412|147173935|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.01||||0.9789|TWO_SIDED|95.0|0.43|2.38|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.38|0.43|0.9789
73811896|NCT04676412|147173936|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.08||||0.8856|TWO_SIDED|95.0|0.36|3.28|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||3.28|0.36|0.8856
73811897|NCT04676412|147173937|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.55||||0.3264|TWO_SIDED|95.0|0.64|3.75|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||3.75|0.64|0.3264
73811898|NCT04676412|147173938|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.31||||0.4068|TWO_SIDED|95.0|0.7|2.46|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.46|0.70|0.4068
73811899|NCT04676412|147173939|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|7.81||||0.002|TWO_SIDED|95.0|1.71|35.62|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||35.62|1.71|0.0020
73811900|NCT04676412|147173940|OTHER|Hazard ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.18||||0.71084|TWO_SIDED|95.0|0.61|2.25|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of enrolling site and baseline PD-L1 status.||||2.25|0.61|0.71084
73811901|NCT04676412|147173941|OTHER||Hazard Ratio (HR)|1.53||||0.8197|TWO_SIDED|95.0|0.61|3.87|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of enrolling site and baseline PD-L1 status.||HR and 95% CIs were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).||3.87|0.61|0.81970
73811902|NCT03315455|147173979|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.016|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.016|<0.0001
73811903|NCT03315455|147173979|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.015|0.082||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.082|0.015|<0.0001
73811904|NCT03315455|147173982|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.026|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.026|<0.0001
73811905|NCT03315455|147173982|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.028|0.092||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.092|0.028|<0.0001
73811906|NCT03315455|147173985|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.006|0.053||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.053|0.006|<0.0001
73811907|NCT03315455|147173985|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.007|0.059||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.059|0.007|<0.0001
73811908|NCT03315455|147173988|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.017|0.102||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.102|0.017|<0.0001
73811909|NCT03315455|147173988|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.013|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.013|<0.0001
73811910|NCT03315455|147173991|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.016|0.163||Not controlled for Type I error|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|||0.163|0.016|<0.0001
73811911|NCT03315455|147173991|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.011|0.122||Not controlled for Type I error|ABR Ratio||The ABR ratio was calculated as Arm B vs. Arm C.|||0.122|0.011|<0.0001
73896315|NCT01252732|147326022|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|2.2|||||TWO_SIDED|95.0|-2.6|7.0||||||||7.0|-2.6|
73811912|NCT03315455|147173996|SUPERIORITY||Difference in Adjusted Means|14.68||||0.0515|TWO_SIDED|95.0|-0.1|29.46||Type I error controlled|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||29.46|-0.10|0.0515
73811913|NCT03315455|147173996|SUPERIORITY||Difference in Adjusted Means|18.33||||0.0204|TWO_SIDED|95.0|2.97|33.68||Type I error controlled|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||33.68|2.97|0.0204
73811914|NCT03315455|147173998|SUPERIORITY||Difference in Adjusted Means|6.06||||0.3281|TWO_SIDED|95.0|-6.27|18.4||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||18.40|-6.27|0.3281
73811915|NCT03315455|147173998|SUPERIORITY||Difference in Adjusted Means|14.01||||0.0297|TWO_SIDED|95.0|1.44|26.59||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||26.59|1.44|0.0297
73811916|NCT03315455|147174001|SUPERIORITY||Difference in Adjusted Means|-3.46||||0.6165|TWO_SIDED|95.0|-17.23|10.31||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||10.31|-17.23|0.6165
73811917|NCT03315455|147174001|SUPERIORITY||Difference in Adjusted Means|-7.58||||0.2797|TWO_SIDED|95.0|-21.48|6.33||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||6.33|-21.48|0.2797
73811918|NCT03315455|147174003|SUPERIORITY||Difference in Adjusted Means|-0.05||||0.489|TWO_SIDED|95.0|-0.18|0.09||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||0.09|-0.18|0.4890
73811919|NCT03315455|147174003|SUPERIORITY||Difference in Adjusted Means|-0.08||||0.2454|TWO_SIDED|95.0|-0.22|0.06||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||0.06|-0.22|0.2454
73811920|NCT04765722|147174032|SUPERIORITY||% change relative to placebo|18.0||||0.99|TWO_SIDED|95.0|-46.4|160.1||The model included treatment group, week, the interaction between treatment group and week, and baseline log-transformed 24-hour cough frequency as fixed effects.|Generalized estimating equations|Hypothesis tests were two-sided, a p\<0.05 indicated statistical significance. We made no adjustments for multiple comparisons across outcomes.||The primary outcome was the change from baseline in log-transformed 24-hour cough frequency (coughs/hour) at week 14.||160.1|-46.4|0.99
73811921|NCT03030118|147174048|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||For the primary outcome (SLICC classification criteria count \[SLICC score\]), measured every 12 weeks over a 96-week period, we used an ordinal logistic regression model to compare the estimated slopes over time for the intervention (HCQ) and placebo groups. The model accounted for the ordinal and non-decreasing properties of the SLICC score. Our null hypothesis was that the intervention slope equaled the placebo slope, with a corresponding hypothesis that the slopes were not equal.||||0.72
73811922|NCT03030118|147174049|SUPERIORITY|||||||0.81|||||||Regression, Cox|||Progression to SLE was defined as the number of subjects in whom a SLICC score of 4 was recorded, up to 96 weeks.||||0.81
73811923|NCT03030118|147174050|SUPERIORITY|||||||0.74|||||||Regression, Logistic|||"For the SLEDAI score, we combined responses to model the following groups:~* Score of 0 or 1~* Score of 2 or 3~* Score of 4, 6, or 8"||||0.74
73811924|NCT03030118|147174051|SUPERIORITY|||||||0.77|||||||Regression, Logistic|Ordinal logistic regression||"For analysis, we combined responses ≥3 to model the following groups:~* Score of 0~* Score of 1~* Score of 2~* Score of 3 or higher"||||0.77
73811925|NCT03030118|147174052|SUPERIORITY|||||||0.386|||||||t-test, 2 sided|Paired t-test||||||0.386
73811926|NCT03030118|147174053|SUPERIORITY|||||||0.497|||||||t-test, 2 sided|Paired t-test||||||0.497
73896316|NCT01252732|147326023|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|0.6|||||TWO_SIDED|95.0|-3.7|5.0||||||||5.0|-3.7|
73811927|NCT03030118|147174054|SUPERIORITY|||||||0.99|||||||Regression, Logistic|Ordinal logistic regression||||||0.99
73811928|NCT03030118|147174055|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
73811929|NCT03030118|147174056|NON_INFERIORITY|Outcome with hydroxychloroquine is hypothesized to be not inferior to outcome with placebo.|||||>|0.5|||||||Fisher Exact|||||||>0.5
73811930|NCT03030118|147174057|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73811931|NCT03030118|147174058|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73811932|NCT01911780|147174061|SUPERIORITY_OR_OTHER||Adjusted mean, comparison|-7.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-9.7|-5.3|||LOCF-ANCOVA|Last observation carried forward (LOCF) was used as the imputation method|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.|||-5.3|-9.7|<0.0001
73811933|NCT01911780|147174062|SUPERIORITY_OR_OTHER||Adjusted mean, comparison|-8.6|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-12.7|-4.5||Additional information, the p-value is not adjusted for multiplicity.|LOCF-ANCOVA||Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.|||-4.5|-12.7|<0.0001
73811934|NCT01911780|147174063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.1||||0.0052|TWO_SIDED|95.0|1.4|7.1||Additional information, the p-value is not adjusted for multiplicity.|Regression, Logistic|Non-completers considered failures (NCF) was used as the imputation method.|Exact 95 % confidence interval by Clopper and Pearson. Logistic regression includes treatment and center.|||7.1|1.4|0.0052
73811935|NCT01911780|147174065|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-3.1|2.3|||mixed-effects model repeated measures||As a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.|||2.3|-3.1|
73811936|NCT01911780|147174066|SUPERIORITY_OR_OTHER||Adjusted Mean|2.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-1.5|6.1|||mixed-effects model repeated measures||Model includes baseline SBP as a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.|||6.1|-1.5|
73811937|NCT02720744|147174068|SUPERIORITY||Mean Difference (Net)|6.13|||<|0.001|TWO_SIDED|95.0|3.52|8.75||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|Mixed Models Analysis|P-values were estimated using an MMRM with change from baseline (or its log transformation).|Difference from placebo was defined by the FT218 mean value minus placebo value.|||8.75|3.52|<0.001
73811938|NCT02720744|147174069|SUPERIORITY||Odds Ratio (OR)|5.56|||<|0.001|TWO_SIDED|95.0|2.76|11.23||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|GLIMMIX model|P-values estimated with categorized CGI-Improvement response (very much or much improved versus other category) at the specific visit.||||11.23|2.76|<0.001
73811939|NCT02720744|147174070|SUPERIORITY||Mean Difference (Net)|-6.65|||<|0.001|TWO_SIDED|95.0|-9.32|-3.98||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|Mixed Models Analysis|P-values were estimated using an MMRM with change from baseline to the end of the respective treatment period.||||-3.98|-9.32|<0.001
73811940|NCT00480493|147174085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|3.36||0.468|TWO_SIDED|95.0|-4.32|9.24|||t-test, 2 sided||Confidence scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if the change in Confidence score was significantly different between the groups.||9.24|-4.32|0.468
73811941|NCT00480493|147174086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.82|STANDARD_ERROR_OF_MEAN|10.05||0.634|TWO_SIDED|95.0|-15.47|25.11|||t-test, 2 sided||Concern scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if there were significant differences in Concern between the two groups at 12 months.||25.11|-15.47|0.634
73811942|NCT00480493|147174087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|3.12||0.43|TWO_SIDED|95.0|-8.76|3.8|||t-test, 2 sided||We also used a random-effect, mixed regression models to look for between group changes over time.|The difference in the Worry score at 12 months was compared between the groups using a 2 sided t-test.||3.80|-8.76|0.430
73811943|NCT01032070|147174103|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||The study was not powered for this comparison due to small sample size.||||0.2200
73811944|NCT04027075|147174117|SUPERIORITY||Odds Ratio (OR)|1.02||||0.962|TWO_SIDED|95.0|0.51|2.02|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.02|0.51|.962
73811945|NCT04027075|147174118|SUPERIORITY||Odds Ratio (OR)|0.47||||0.109|TWO_SIDED|95.0|0.19|1.18|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||1.18|0.19|.109
73811946|NCT04027075|147174119|SUPERIORITY||Odds Ratio (OR)|1.58||||0.227|TWO_SIDED|95.0|0.75|3.29|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||3.29|0.75|.227
73811947|NCT04027075|147174120|SUPERIORITY||Odds Ratio (OR)|1.2||||0.681|TWO_SIDED|95.0|0.5|2.87|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.87|0.50|.681
73811948|NCT04027075|147174121|SUPERIORITY||Odds Ratio (OR)|1.18||||0.65|TWO_SIDED|95.0|0.58|2.42|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.42|0.58|.650
73811949|NCT04027075|147174122|SUPERIORITY||Odds Ratio (OR)|1.41||||0.304|TWO_SIDED|95.0|0.73|2.73|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.73|0.73|.304
73811950|NCT04027075|147174123|SUPERIORITY||Odds Ratio (OR)|1.44||||0.97|TWO_SIDED|95.0|0.69|3.0|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||3.00|0.69|0.97
73811951|NCT04027075|147174124|SUPERIORITY||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|0.64||0.005|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.005
73811952|NCT04027075|147174125|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.09||0.46|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.460
73811953|NCT04027075|147174126|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.26||0.851|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.851
73811954|NCT04027075|147174127|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.23||0.977|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.977
73811955|NCT04027075|147174128|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.456|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.456
73811956|NCT04027075|147174129|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.31||0.874|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.874
73811957|NCT04027075|147174130|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.24||0.069|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.069
73811958|NCT04027075|147174131|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.658|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.658
73811959|NCT04027075|147174132|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.783|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.783
73811960|NCT00738062|147174133|SUPERIORITY_OR_OTHER|||||||0.438|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.438
73811961|NCT00738062|147174134|SUPERIORITY_OR_OTHER|||||||0.554|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHDAS Composite value at randomization.||||||0.554
73811962|NCT00738062|147174135|SUPERIORITY_OR_OTHER|||||||0.198|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Composite value at baseline.||||||0.198
73811963|NCT00738062|147174136|SUPERIORITY_OR_OTHER|||||||0.286|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.286
73811964|NCT00738062|147174137|SUPERIORITY_OR_OTHER|||||||0.251|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.251
73811965|NCT00738062|147174138|SUPERIORITY_OR_OTHER|||||||0.708|||||||Fisher Exact|||||||0.708
73811966|NCT00738062|147174139|SUPERIORITY_OR_OTHER|||||||0.873|||||||Fisher Exact|||||||0.873
73811967|NCT00738062|147174140|SUPERIORITY_OR_OTHER|||||||0.252|||||||Fisher Exact|||||||0.252
73811968|NCT00738062|147174141|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||||||0.330
73811969|NCT00426660|147174161|SUPERIORITY_OR_OTHER||75th percentile (median)|169.0|||||TWO_SIDED|95.0|135.0|178.0||||||||178.0|135.0|
73811970|NCT00426660|147174161|SUPERIORITY_OR_OTHER||50th percentile (median)|86.5|||||TWO_SIDED|95.0|82.0|92.0||||||||92.0|82.0|
73811971|NCT00426660|147174161|SUPERIORITY_OR_OTHER||25th percentile (median)|58.0|||||TWO_SIDED|95.0|57.0|62.0||||||||62.0|57.0|
73811972|NCT00980174|147174190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.8|||<|0.0001|TWO_SIDED|95.0|4.0|5.6|||ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||5.6|4.0|<0.0001
73811973|NCT00980174|147174191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.5|2.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||2.6|1.5|<0.0001
73811974|NCT00980174|147174192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|||<|0.0001|TWO_SIDED|95.0|1.3|3.0||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||3.0|1.3|<0.0001
73811975|NCT00980174|147174193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|1.4|3.2||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||3.2|1.4|<0.0001
73811976|NCT00980174|147174194|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.9||||0.0144|TWO_SIDED|95.0|0.2|1.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||1.6|0.2|0.0144
73811977|NCT00980174|147174195|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value is adjusted for multiple comparisons by Hochberg method|Van Elteren Rank Test|Adjusted by level of baseline bone mineral density T-score||||||<0.0001
73811978|NCT00455520|147174196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-1.7|-0.92|||ANCOVA|||Analysis of Covariance Model with factors of treatment, country, prior opioid use, and baseline dose level and start of DB pain score as factors.||-0.92|-1.7|<0.001
73811979|NCT01541839|147174211|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|327.0|STANDARD_DEVIATION|70.0|<|0.0001|TWO_SIDED|95.0|||||t-test, 1 sided||The mean time for closure with septal stapler was 35 +/-22 seconds versus 7 minutes +/- 1 minute 10 seconds for suture closure. The mean net difference between groups was 327 seconds, or 6 minutes 27 seconds.|The operative time required for closure and NOSE questionnaire scores were analyzed with unpaired and paired t-tests respectively. Chi-squared testing was used for post-operative complication rates. The mean closure time for septoplasty was estimated to be 10 minutes +/- 4 minutes. It was assumed that the septal stapler would take 5 minutes +/- 4 minutes. Assuming a one-sided test, an alpha of 0.05 and a power of 0.8, a total of 16 patients were needed.||||<0.0001
73811980|NCT00783224|147174213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
73811981|NCT00783224|147174213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
73811982|NCT02635542|147174214|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
73811983|NCT02635542|147174215|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
73811984|NCT00551161|147174235|SUPERIORITY_OR_OTHER||||||<|0.05||||||Due to the exploratory nature of these analyses, no adjustment for multiple testing was made. Although it would have been preferable to carry out an omnibus analysis, due to the small sample size, the descriptive approach described above was used.|Wilcoxon (Mann-Whitney)|||The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 \[(t2 - t1) - (t1 - t0)\] for each of the metabolites and ratios, in order to examine whether the rate of change differed while on monotherapy as compared with combination therapy.||||<0.05
73811985|NCT01935700|147174236|NON_INFERIORITY|Non-inferiority was defined as no statistically significant difference (P value \> 0.05) in median survival between the colchicine group and the sorafenib treated group.||||||0.4593|||||||Mann-Whitney U test|||||||0.4593
73811986|NCT01935700|147174236|NON_INFERIORITY|Non-inferiority was defined as no statistically significant difference (P value \> 0.05) in survival between the colchicine group and the sorafenib treated group.||||||0.329|||||||Log Rank|||||||0.3290
73811987|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0552||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of pneumonia between two groups||||0.0552
73811988|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0184||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of biliary tract obstruction between two groups||||0.0184
73811989|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0931||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of cholangitis between two groups||||0.0931
73811990|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0506||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of peritonitis between two groups||||0.0506
73811991|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of sepsis between two groups||||1
73811992|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.5374||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of diarrhea between two groups||||0.5374
73811993|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.14||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of anorexia between two groups||||0.14
73811994|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.4584||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of abdominal pain between two groups||||0.4584
73811995|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of skin rash between two groups||||1
73811996|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of palmar-plantar erythrodysesthesia syndrome between two groups||||1
73811997|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypertension between two groups||||1
73811998|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.5958||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hemorrhage between two groups||||0.5958
73811999|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.14||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypoglycemia between two groups||||0.14
73812000|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hyperglycemia between two groups||||1
73812001|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypocalcemia between two groups||||1
73812002|NCT01935700|147174237|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of pleural effusion between two groups||||1
73812003|NCT00772005|147174263|SUPERIORITY_OR_OTHER|||||||0.8514||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8514
73812004|NCT00772005|147174263|SUPERIORITY_OR_OTHER|||||||0.6995||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6995
73812005|NCT00772005|147174263|SUPERIORITY_OR_OTHER|||||||0.9766||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9766
73812006|NCT00772005|147174264|SUPERIORITY_OR_OTHER|||||||0.7596||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7596
73812007|NCT00772005|147174264|SUPERIORITY_OR_OTHER|||||||0.562||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5620
73812008|NCT00772005|147174264|SUPERIORITY_OR_OTHER|||||||0.6688||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6688
73812009|NCT00772005|147174265|SUPERIORITY_OR_OTHER|||||||0.1894||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1894
73812010|NCT00772005|147174265|SUPERIORITY_OR_OTHER|||||||0.4582||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4582
73812011|NCT00772005|147174265|SUPERIORITY_OR_OTHER|||||||0.0327||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0327
73812012|NCT00772005|147174266|SUPERIORITY_OR_OTHER|||||||0.3275||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3275
73812013|NCT00772005|147174266|SUPERIORITY_OR_OTHER|||||||0.2597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2597
73812014|NCT00772005|147174266|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0039
73812015|NCT00772005|147174267|SUPERIORITY_OR_OTHER|||||||0.0713||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0713
73812016|NCT00772005|147174267|SUPERIORITY_OR_OTHER|||||||0.0431||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0431
73812017|NCT00772005|147174267|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0063
73812018|NCT00772005|147174268|SUPERIORITY_OR_OTHER|||||||0.0619||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0619
73812019|NCT00772005|147174268|SUPERIORITY_OR_OTHER|||||||0.1137||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1137
73812020|NCT00772005|147174268|SUPERIORITY_OR_OTHER|||||||0.0598||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0598
73812021|NCT00772005|147174269|SUPERIORITY_OR_OTHER|||||||0.7093||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7093
73812022|NCT00772005|147174269|SUPERIORITY_OR_OTHER|||||||0.5129||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5129
73812023|NCT00772005|147174269|SUPERIORITY_OR_OTHER|||||||0.1097||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1097
73812024|NCT00772005|147174270|SUPERIORITY_OR_OTHER|||||||0.4291||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4291
73812025|NCT00772005|147174270|SUPERIORITY_OR_OTHER|||||||0.3195||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3195
73812026|NCT00772005|147174270|SUPERIORITY_OR_OTHER|||||||0.1591||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1591
73812027|NCT00772005|147174271|SUPERIORITY_OR_OTHER|||||||0.7768||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7768
73812028|NCT00772005|147174271|SUPERIORITY_OR_OTHER|||||||0.4014||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4014
73812029|NCT00772005|147174271|SUPERIORITY_OR_OTHER|||||||0.4016||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4016
73812030|NCT00772005|147174272|SUPERIORITY_OR_OTHER|||||||0.5612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5612
73812031|NCT00772005|147174272|SUPERIORITY_OR_OTHER|||||||0.9704||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9704
73812032|NCT00772005|147174272|SUPERIORITY_OR_OTHER|||||||0.2424||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2424
73812033|NCT00772005|147174273|SUPERIORITY_OR_OTHER|||||||0.8847||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8847
73812034|NCT00772005|147174273|SUPERIORITY_OR_OTHER|||||||0.2958||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2958
73812035|NCT00772005|147174273|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2660
73812036|NCT00772005|147174274|SUPERIORITY_OR_OTHER|||||||0.0524||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0524
73812037|NCT00772005|147174274|SUPERIORITY_OR_OTHER|||||||0.0328||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0328
73812038|NCT00772005|147174274|SUPERIORITY_OR_OTHER|||||||0.0084||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0084
73812039|NCT00772005|147174275|SUPERIORITY_OR_OTHER|||||||0.3651||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3651
73812040|NCT00772005|147174275|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0096
73812041|NCT00772005|147174275|SUPERIORITY_OR_OTHER|||||||0.0327||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0327
73812042|NCT00772005|147174276|SUPERIORITY_OR_OTHER|||||||0.2091||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2091
73812043|NCT00772005|147174276|SUPERIORITY_OR_OTHER|||||||0.0706||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0706
73812044|NCT00772005|147174276|SUPERIORITY_OR_OTHER|||||||0.3052||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3052
73812045|NCT00772005|147174277|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9960
73812046|NCT00772005|147174277|SUPERIORITY_OR_OTHER|||||||0.3604||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3604
73812047|NCT00772005|147174277|SUPERIORITY_OR_OTHER|||||||0.9528||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9528
73812048|NCT00772005|147174278|SUPERIORITY_OR_OTHER|||||||0.9797||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9797
73812049|NCT00772005|147174278|SUPERIORITY_OR_OTHER|||||||0.6173||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6173
73812050|NCT00772005|147174278|SUPERIORITY_OR_OTHER|||||||0.5415||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5415
73812051|NCT00772005|147174279|SUPERIORITY_OR_OTHER|||||||0.3547||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3547
73812052|NCT00772005|147174279|SUPERIORITY_OR_OTHER|||||||0.6642||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6642
73812053|NCT00772005|147174279|SUPERIORITY_OR_OTHER|||||||0.7395||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7395
73812054|NCT00772005|147174280|SUPERIORITY_OR_OTHER|||||||0.8124||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8124
73812055|NCT00772005|147174280|SUPERIORITY_OR_OTHER|||||||0.8961||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8961
73812056|NCT00772005|147174280|SUPERIORITY_OR_OTHER|||||||0.4999||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4999
73812057|NCT00772005|147174290|SUPERIORITY_OR_OTHER|||||||0.454||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4540
73812058|NCT00772005|147174290|SUPERIORITY_OR_OTHER|||||||0.358||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3580
73812059|NCT00772005|147174290|SUPERIORITY_OR_OTHER|||||||0.6271||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6271
73812060|NCT00772005|147174291|SUPERIORITY_OR_OTHER|||||||0.1459||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1459
73812061|NCT00772005|147174291|SUPERIORITY_OR_OTHER|||||||0.6004||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6004
73812062|NCT00772005|147174291|SUPERIORITY_OR_OTHER|||||||0.0192||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0192
73812063|NCT00772005|147174292|SUPERIORITY_OR_OTHER|||||||0.8455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8455
73812064|NCT00772005|147174292|SUPERIORITY_OR_OTHER|||||||0.8715||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8715
73812065|NCT00772005|147174292|SUPERIORITY_OR_OTHER|||||||0.0309||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0309
73812066|NCT00772005|147174293|SUPERIORITY_OR_OTHER|||||||0.2664||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2664
73812067|NCT00772005|147174293|SUPERIORITY_OR_OTHER|||||||0.3528||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3528
73812068|NCT00772005|147174293|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0380
73812069|NCT00772005|147174294|SUPERIORITY_OR_OTHER|||||||0.3316||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3316
73812070|NCT00772005|147174294|SUPERIORITY_OR_OTHER|||||||0.349||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3490
73812071|NCT00772005|147174294|SUPERIORITY_OR_OTHER|||||||0.0926||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0926
73812072|NCT00772005|147174295|SUPERIORITY_OR_OTHER|||||||0.8835||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8835
73812073|NCT00772005|147174295|SUPERIORITY_OR_OTHER|||||||0.9748||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9748
73812074|NCT00772005|147174295|SUPERIORITY_OR_OTHER|||||||0.0883||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0883
73812075|NCT00772005|147174296|SUPERIORITY_OR_OTHER|||||||0.6948||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6948
73812076|NCT00772005|147174296|SUPERIORITY_OR_OTHER|||||||0.3345||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3345
73812077|NCT00772005|147174296|SUPERIORITY_OR_OTHER|||||||0.2447||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2447
73812078|NCT00772005|147174297|SUPERIORITY_OR_OTHER|||||||0.6115||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6115
73812079|NCT00772005|147174297|SUPERIORITY_OR_OTHER|||||||0.2233||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2233
73812080|NCT00772005|147174297|SUPERIORITY_OR_OTHER|||||||0.2343||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2343
73812081|NCT00772005|147174298|SUPERIORITY_OR_OTHER|||||||0.8228||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8228
73812082|NCT00772005|147174298|SUPERIORITY_OR_OTHER|||||||0.9373||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9373
73812083|NCT00772005|147174298|SUPERIORITY_OR_OTHER|||||||0.319||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3190
73812084|NCT00772005|147174299|SUPERIORITY_OR_OTHER|||||||0.9769||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9769
73812085|NCT00772005|147174299|SUPERIORITY_OR_OTHER|||||||0.8374||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8374
73812086|NCT00772005|147174299|SUPERIORITY_OR_OTHER|||||||0.7061||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7061
73812087|NCT00772005|147174300|SUPERIORITY_OR_OTHER|||||||0.9577||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9577
73812088|NCT00772005|147174300|SUPERIORITY_OR_OTHER|||||||0.5106||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5106
73812089|NCT00772005|147174300|SUPERIORITY_OR_OTHER|||||||0.2655||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2655
73812090|NCT00772005|147174301|SUPERIORITY_OR_OTHER|||||||0.3825||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3825
73812091|NCT00772005|147174301|SUPERIORITY_OR_OTHER|||||||0.2003||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2003
73812092|NCT00772005|147174301|SUPERIORITY_OR_OTHER|||||||0.0625||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0625
73812093|NCT00772005|147174302|SUPERIORITY_OR_OTHER|||||||0.2981||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2981
73812094|NCT00772005|147174302|SUPERIORITY_OR_OTHER|||||||0.0104||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0104
73812095|NCT00772005|147174302|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0150
73812096|NCT00772005|147174303|SUPERIORITY_OR_OTHER|||||||0.4608||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4608
73812097|NCT00772005|147174303|SUPERIORITY_OR_OTHER|||||||0.0807||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0807
73812098|NCT00772005|147174303|SUPERIORITY_OR_OTHER|||||||0.2959||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2959
73812099|NCT00772005|147174304|SUPERIORITY_OR_OTHER|||||||0.6759||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6759
73812100|NCT00772005|147174304|SUPERIORITY_OR_OTHER|||||||0.2418||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2418
73812101|NCT00772005|147174304|SUPERIORITY_OR_OTHER|||||||0.9808||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9808
73812102|NCT00772005|147174305|SUPERIORITY_OR_OTHER|||||||0.7599||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7599
73812103|NCT00772005|147174305|SUPERIORITY_OR_OTHER|||||||0.4543||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4543
73812104|NCT00772005|147174305|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6040
73812105|NCT00772005|147174306|SUPERIORITY_OR_OTHER|||||||0.2476||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2476
73812106|NCT00772005|147174306|SUPERIORITY_OR_OTHER|||||||0.949||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9490
73812107|NCT00772005|147174306|SUPERIORITY_OR_OTHER|||||||0.9035||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9035
73812108|NCT00772005|147174307|SUPERIORITY_OR_OTHER|||||||0.9472||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9472
73812109|NCT00772005|147174307|SUPERIORITY_OR_OTHER|||||||0.8335||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8335
73812110|NCT00772005|147174307|SUPERIORITY_OR_OTHER|||||||0.5674||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5674
73812111|NCT00772005|147174308|SUPERIORITY_OR_OTHER|||||||0.3536||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3536
73812112|NCT00772005|147174308|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1940
73812113|NCT00772005|147174308|SUPERIORITY_OR_OTHER|||||||0.2129||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2129
73812114|NCT00772005|147174309|SUPERIORITY_OR_OTHER|||||||0.584||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5840
73812115|NCT00772005|147174309|SUPERIORITY_OR_OTHER|||||||0.6028||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6028
73812116|NCT00772005|147174309|SUPERIORITY_OR_OTHER|||||||0.1426||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1426
73812117|NCT00772005|147174310|SUPERIORITY_OR_OTHER|||||||0.5989||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5989
73812118|NCT00772005|147174310|SUPERIORITY_OR_OTHER|||||||0.7411||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7411
73812119|NCT00772005|147174310|SUPERIORITY_OR_OTHER|||||||0.1566||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1566
73812120|NCT00772005|147174311|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2610
73812121|NCT00772005|147174311|SUPERIORITY_OR_OTHER|||||||0.4457||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4457
73812122|NCT00772005|147174311|SUPERIORITY_OR_OTHER|||||||0.1342||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1342
73812123|NCT00772005|147174312|SUPERIORITY_OR_OTHER|||||||0.0974||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0974
73812124|NCT00772005|147174312|SUPERIORITY_OR_OTHER|||||||0.664||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6640
73812125|NCT00772005|147174312|SUPERIORITY_OR_OTHER|||||||0.1507||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1507
73812126|NCT00772005|147174313|SUPERIORITY_OR_OTHER|||||||0.7649||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7649
73812127|NCT00772005|147174313|SUPERIORITY_OR_OTHER|||||||0.4866||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4866
73812128|NCT00772005|147174313|SUPERIORITY_OR_OTHER|||||||0.5002||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5002
73812129|NCT00772005|147174314|SUPERIORITY_OR_OTHER|||||||0.2076||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2076
73812130|NCT00772005|147174314|SUPERIORITY_OR_OTHER|||||||0.9355||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9355
73812131|NCT00772005|147174314|SUPERIORITY_OR_OTHER|||||||0.189||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1890
73812132|NCT00772005|147174315|SUPERIORITY_OR_OTHER|||||||0.632||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6320
73812133|NCT00772005|147174315|SUPERIORITY_OR_OTHER|||||||0.8777||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8777
73812134|NCT00772005|147174315|SUPERIORITY_OR_OTHER|||||||0.4378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4378
73812135|NCT00772005|147174316|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5544
73812136|NCT00772005|147174316|SUPERIORITY_OR_OTHER|||||||0.4446||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4446
73812137|NCT00772005|147174316|SUPERIORITY_OR_OTHER|||||||0.4483||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4483
73812138|NCT00772005|147174317|SUPERIORITY_OR_OTHER|||||||0.1914||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1914
73812139|NCT00772005|147174317|SUPERIORITY_OR_OTHER|||||||0.2543||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2543
73812140|NCT00772005|147174317|SUPERIORITY_OR_OTHER|||||||0.9748||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9748
73812141|NCT00772005|147174318|SUPERIORITY_OR_OTHER|||||||0.5312||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5312
73812142|NCT00772005|147174318|SUPERIORITY_OR_OTHER|||||||0.7522||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7522
73812143|NCT00772005|147174318|SUPERIORITY_OR_OTHER|||||||0.3183||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3183
73812144|NCT00772005|147174319|SUPERIORITY_OR_OTHER|||||||0.5879||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5879
73812145|NCT00772005|147174319|SUPERIORITY_OR_OTHER|||||||0.891||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8910
73812146|NCT00772005|147174319|SUPERIORITY_OR_OTHER|||||||0.1795||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1795
73812147|NCT00772005|147174320|SUPERIORITY_OR_OTHER|||||||0.6378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6378
73812148|NCT00772005|147174320|SUPERIORITY_OR_OTHER|||||||0.8679||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8679
73812149|NCT00772005|147174320|SUPERIORITY_OR_OTHER|||||||0.5489||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5489
73812150|NCT00772005|147174321|SUPERIORITY_OR_OTHER|||||||0.9337||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9337
73812151|NCT00772005|147174321|SUPERIORITY_OR_OTHER|||||||0.9428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9428
73812152|NCT00772005|147174321|SUPERIORITY_OR_OTHER|||||||0.5895||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5895
73812153|NCT00772005|147174322|SUPERIORITY_OR_OTHER|||||||0.8695||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8695
73812154|NCT00772005|147174322|SUPERIORITY_OR_OTHER|||||||0.6637||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6637
73812155|NCT00772005|147174322|SUPERIORITY_OR_OTHER|||||||0.3152||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3152
73812156|NCT00772005|147174323|SUPERIORITY_OR_OTHER|||||||0.7472||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7472
73812157|NCT00772005|147174323|SUPERIORITY_OR_OTHER|||||||0.4503||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4503
73812158|NCT00772005|147174323|SUPERIORITY_OR_OTHER|||||||0.3127||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3127
73812159|NCT00772005|147174324|SUPERIORITY_OR_OTHER|||||||0.9193||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9193
73812160|NCT00772005|147174324|SUPERIORITY_OR_OTHER|||||||0.4814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4814
73812161|NCT00772005|147174324|SUPERIORITY_OR_OTHER|||||||0.6097||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6097
73812162|NCT00772005|147174325|SUPERIORITY_OR_OTHER|||||||0.8594||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8594
73812163|NCT00772005|147174325|SUPERIORITY_OR_OTHER|||||||0.6157||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6157
73812164|NCT00772005|147174325|SUPERIORITY_OR_OTHER|||||||0.4846||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4846
73812165|NCT00772005|147174326|SUPERIORITY_OR_OTHER|||||||0.6076||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6076
73812166|NCT00772005|147174326|SUPERIORITY_OR_OTHER|||||||0.5827||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5827
73812167|NCT00772005|147174326|SUPERIORITY_OR_OTHER|||||||0.7865||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7865
73812168|NCT00772005|147174327|SUPERIORITY_OR_OTHER|||||||0.3045||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3045
73812169|NCT00772005|147174327|SUPERIORITY_OR_OTHER|||||||0.0617||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0617
73812170|NCT00772005|147174327|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0580
73812171|NCT00772005|147174328|SUPERIORITY_OR_OTHER|||||||0.0194||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0194
73812172|NCT00772005|147174328|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2270
73812173|NCT00772005|147174328|SUPERIORITY_OR_OTHER|||||||0.1181||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1181
73812174|NCT00772005|147174329|SUPERIORITY_OR_OTHER|||||||0.1348||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1348
73812175|NCT00772005|147174329|SUPERIORITY_OR_OTHER|||||||0.0419||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0419
73812176|NCT00772005|147174329|SUPERIORITY_OR_OTHER|||||||0.0146||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0146
73812177|NCT00772005|147174330|SUPERIORITY_OR_OTHER|||||||0.1292||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1292
73812178|NCT00772005|147174330|SUPERIORITY_OR_OTHER|||||||0.3773||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3773
73812179|NCT00772005|147174330|SUPERIORITY_OR_OTHER|||||||0.1348||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1348
73812180|NCT00772005|147174331|SUPERIORITY_OR_OTHER|||||||0.9642||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9642
73812181|NCT00772005|147174331|SUPERIORITY_OR_OTHER|||||||0.7814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7814
73812182|NCT00772005|147174331|SUPERIORITY_OR_OTHER|||||||0.1455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1455
73812183|NCT00772005|147174332|SUPERIORITY_OR_OTHER|||||||0.5722||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5722
73812184|NCT00772005|147174332|SUPERIORITY_OR_OTHER|||||||0.1352||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1352
73812185|NCT00772005|147174332|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0630
73812186|NCT00772005|147174333|SUPERIORITY_OR_OTHER|||||||0.4607||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4607
73812187|NCT00772005|147174333|SUPERIORITY_OR_OTHER|||||||0.2538||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2538
73812188|NCT00772005|147174333|SUPERIORITY_OR_OTHER|||||||0.3406||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3406
73812189|NCT00772005|147174334|SUPERIORITY_OR_OTHER|||||||0.8116||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8116
73812190|NCT00772005|147174334|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6870
73812191|NCT00772005|147174334|SUPERIORITY_OR_OTHER|||||||0.8112||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8112
73812192|NCT00772005|147174335|SUPERIORITY_OR_OTHER|||||||0.9786||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9786
73812193|NCT00772005|147174335|SUPERIORITY_OR_OTHER|||||||0.5879||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5879
73812194|NCT00772005|147174335|SUPERIORITY_OR_OTHER|||||||0.3973||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3973
73812195|NCT00772005|147174336|SUPERIORITY_OR_OTHER|||||||0.403||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4030
73812196|NCT00772005|147174336|SUPERIORITY_OR_OTHER|||||||0.3777||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3777
73812197|NCT00772005|147174336|SUPERIORITY_OR_OTHER|||||||0.6493||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6493
73812198|NCT00772005|147174337|SUPERIORITY_OR_OTHER|||||||0.9871||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9871
73812199|NCT00772005|147174337|SUPERIORITY_OR_OTHER|||||||0.5859||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5859
73812200|NCT00772005|147174337|SUPERIORITY_OR_OTHER|||||||0.0328||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0328
73812201|NCT00772005|147174338|SUPERIORITY_OR_OTHER|||||||0.2318||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2318
73812202|NCT00772005|147174338|SUPERIORITY_OR_OTHER|||||||0.6211||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6211
73812203|NCT00772005|147174338|SUPERIORITY_OR_OTHER|||||||0.3125||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3125
73812204|NCT00772005|147174339|SUPERIORITY_OR_OTHER|||||||0.2425||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2425
73812205|NCT00772005|147174339|SUPERIORITY_OR_OTHER|||||||0.6597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6597
73812206|NCT00772005|147174339|SUPERIORITY_OR_OTHER|||||||0.4753||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4753
73812207|NCT00772005|147174340|SUPERIORITY_OR_OTHER|||||||0.1715||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1715
73812208|NCT00772005|147174340|SUPERIORITY_OR_OTHER|||||||0.3056||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3056
73812209|NCT00772005|147174340|SUPERIORITY_OR_OTHER|||||||0.0083||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0083
73812210|NCT00772005|147174341|SUPERIORITY_OR_OTHER|||||||0.2681||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2681
73812211|NCT00772005|147174341|SUPERIORITY_OR_OTHER|||||||0.1475||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1475
73812212|NCT00772005|147174341|SUPERIORITY_OR_OTHER|||||||0.0647||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0647
73812213|NCT00772005|147174342|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1670
73812214|NCT00772005|147174342|SUPERIORITY_OR_OTHER|||||||0.1737||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1737
73812215|NCT00772005|147174342|SUPERIORITY_OR_OTHER|||||||0.372||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3720
73812216|NCT00772005|147174343|SUPERIORITY_OR_OTHER|||||||0.3547||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3547
73812217|NCT00772005|147174343|SUPERIORITY_OR_OTHER|||||||0.6043||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6043
73812218|NCT00772005|147174343|SUPERIORITY_OR_OTHER|||||||0.0463||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0463
73812219|NCT00772005|147174344|SUPERIORITY_OR_OTHER|||||||0.9258||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9258
73812220|NCT00772005|147174344|SUPERIORITY_OR_OTHER|||||||0.9116||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9116
73812221|NCT00772005|147174344|SUPERIORITY_OR_OTHER|||||||0.4848||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4848
73812222|NCT00772005|147174345|SUPERIORITY_OR_OTHER|||||||0.7612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7612
73812223|NCT00772005|147174345|SUPERIORITY_OR_OTHER|||||||0.5761||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5761
73812224|NCT00772005|147174345|SUPERIORITY_OR_OTHER|||||||0.1576||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1576
73812225|NCT00772005|147174346|SUPERIORITY_OR_OTHER|||||||0.9565||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9565
73812226|NCT00772005|147174346|SUPERIORITY_OR_OTHER|||||||0.9178||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9178
73812227|NCT00772005|147174346|SUPERIORITY_OR_OTHER|||||||0.1491||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1491
73812228|NCT00772005|147174347|SUPERIORITY_OR_OTHER|||||||0.7056||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7056
73812229|NCT00772005|147174347|SUPERIORITY_OR_OTHER|||||||0.5179||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5179
73812230|NCT00772005|147174347|SUPERIORITY_OR_OTHER|||||||0.4585||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4585
73812231|NCT00772005|147174348|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0690
73812232|NCT00772005|147174348|SUPERIORITY_OR_OTHER|||||||0.5324||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5324
73812233|NCT00772005|147174348|SUPERIORITY_OR_OTHER|||||||0.0946||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0946
73812234|NCT00772005|147174349|SUPERIORITY_OR_OTHER|||||||0.1878||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1878
73812235|NCT00772005|147174349|SUPERIORITY_OR_OTHER|||||||0.4294||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4294
73812236|NCT00772005|147174349|SUPERIORITY_OR_OTHER|||||||0.6504||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6504
73812237|NCT00772005|147174350|SUPERIORITY_OR_OTHER|||||||0.4022||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4022
73812238|NCT00772005|147174350|SUPERIORITY_OR_OTHER|||||||0.6246||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6246
73812239|NCT00772005|147174350|SUPERIORITY_OR_OTHER|||||||0.8655||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8655
73812240|NCT00772005|147174351|SUPERIORITY_OR_OTHER|||||||0.5676||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5676
73812241|NCT00772005|147174351|SUPERIORITY_OR_OTHER|||||||0.5239||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5239
73812242|NCT00772005|147174351|SUPERIORITY_OR_OTHER|||||||0.4092||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4092
73812243|NCT00772005|147174352|SUPERIORITY_OR_OTHER|||||||0.5195||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5195
73812244|NCT00772005|147174352|SUPERIORITY_OR_OTHER|||||||0.1732||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1732
73812245|NCT00772005|147174352|SUPERIORITY_OR_OTHER|||||||0.7455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7455
73812246|NCT00772005|147174353|SUPERIORITY_OR_OTHER|||||||0.6885||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6885
73812247|NCT00772005|147174353|SUPERIORITY_OR_OTHER|||||||0.5443||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5443
73812248|NCT00772005|147174353|SUPERIORITY_OR_OTHER|||||||0.9343||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9343
73812249|NCT00772005|147174354|SUPERIORITY_OR_OTHER|||||||0.9093||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9093
73812250|NCT00772005|147174354|SUPERIORITY_OR_OTHER|||||||0.4701||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4701
73812251|NCT00772005|147174354|SUPERIORITY_OR_OTHER|||||||0.9764||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9764
73812252|NCT00772005|147174355|SUPERIORITY_OR_OTHER|||||||0.8115||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8115
73812253|NCT00772005|147174355|SUPERIORITY_OR_OTHER|||||||0.5378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5378
73812254|NCT00772005|147174355|SUPERIORITY_OR_OTHER|||||||0.9144||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9144
73812255|NCT00772005|147174356|SUPERIORITY_OR_OTHER|||||||0.9812||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9812
73812256|NCT00772005|147174356|SUPERIORITY_OR_OTHER|||||||0.5464||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5464
73812257|NCT00772005|147174356|SUPERIORITY_OR_OTHER|||||||0.8811||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8811
73812258|NCT00772005|147174357|SUPERIORITY_OR_OTHER|||||||0.6487||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6487
73812259|NCT00772005|147174357|SUPERIORITY_OR_OTHER|||||||0.4204||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4204
73812260|NCT00772005|147174357|SUPERIORITY_OR_OTHER|||||||0.6955||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6955
73812261|NCT00772005|147174358|SUPERIORITY_OR_OTHER|||||||0.6042||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6042
73812262|NCT00772005|147174358|SUPERIORITY_OR_OTHER|||||||0.9783||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9783
73812263|NCT00772005|147174358|SUPERIORITY_OR_OTHER|||||||0.9739||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9739
73812264|NCT00772005|147174359|SUPERIORITY_OR_OTHER|||||||0.3466||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3466
73812265|NCT00772005|147174359|SUPERIORITY_OR_OTHER|||||||0.8469||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8469
73812266|NCT00772005|147174359|SUPERIORITY_OR_OTHER|||||||0.5439||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5439
73812267|NCT00772005|147174360|SUPERIORITY_OR_OTHER|||||||0.6059||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6059
73812268|NCT00772005|147174360|SUPERIORITY_OR_OTHER|||||||0.7474||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7474
73812269|NCT00772005|147174360|SUPERIORITY_OR_OTHER|||||||0.4424||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4424
73812270|NCT00772005|147174361|SUPERIORITY_OR_OTHER|||||||0.4874||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4874
73812271|NCT00772005|147174361|SUPERIORITY_OR_OTHER|||||||0.8243||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8243
73812272|NCT00772005|147174361|SUPERIORITY_OR_OTHER|||||||0.9562||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9562
73812273|NCT00772005|147174362|SUPERIORITY_OR_OTHER|||||||0.3686||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3686
73812274|NCT00772005|147174362|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0270
73812275|NCT00772005|147174362|SUPERIORITY_OR_OTHER|||||||0.7322||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7322
73812276|NCT00772005|147174363|SUPERIORITY_OR_OTHER|||||||0.4646||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4646
73812277|NCT00772005|147174363|SUPERIORITY_OR_OTHER|||||||0.8783||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8783
73812278|NCT00772005|147174363|SUPERIORITY_OR_OTHER|||||||0.4213||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4213
73812279|NCT00772005|147174364|SUPERIORITY_OR_OTHER|||||||0.6597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6597
73812280|NCT00772005|147174364|SUPERIORITY_OR_OTHER|||||||0.0262||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0262
73812281|NCT00772005|147174364|SUPERIORITY_OR_OTHER|||||||0.6652||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6652
73812282|NCT00772005|147174365|SUPERIORITY_OR_OTHER|||||||0.3355||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3355
73812283|NCT00772005|147174365|SUPERIORITY_OR_OTHER|||||||0.0953||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0953
73812284|NCT00772005|147174365|SUPERIORITY_OR_OTHER|||||||0.9235||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9235
73812285|NCT00772005|147174366|SUPERIORITY_OR_OTHER|||||||0.4164||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4164
73812286|NCT00772005|147174366|SUPERIORITY_OR_OTHER|||||||0.3003||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3003
73812287|NCT00772005|147174366|SUPERIORITY_OR_OTHER|||||||0.6907||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6907
73812288|NCT00772005|147174367|SUPERIORITY_OR_OTHER|||||||0.2518||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2518
73812289|NCT00772005|147174367|SUPERIORITY_OR_OTHER|||||||0.0739||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0739
73812290|NCT00772005|147174367|SUPERIORITY_OR_OTHER|||||||0.5644||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5644
73812291|NCT00772005|147174368|SUPERIORITY_OR_OTHER|||||||0.4305||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4305
73812292|NCT00772005|147174368|SUPERIORITY_OR_OTHER|||||||0.8299||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8299
73812293|NCT00772005|147174368|SUPERIORITY_OR_OTHER|||||||0.7283||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7283
73812294|NCT00772005|147174369|SUPERIORITY_OR_OTHER|||||||0.761||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7610
73812295|NCT00772005|147174369|SUPERIORITY_OR_OTHER|||||||0.6091||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6091
73812296|NCT00772005|147174369|SUPERIORITY_OR_OTHER|||||||0.3368||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3368
73812297|NCT00772005|147174370|SUPERIORITY_OR_OTHER|||||||0.8457||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8457
73812298|NCT00772005|147174370|SUPERIORITY_OR_OTHER|||||||0.4531||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4531
73812299|NCT00772005|147174370|SUPERIORITY_OR_OTHER|||||||0.6867||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6867
73812300|NCT00772005|147174371|SUPERIORITY_OR_OTHER|||||||0.9705||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9705
73812301|NCT00772005|147174371|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0021
73812302|NCT00772005|147174371|SUPERIORITY_OR_OTHER|||||||0.5013||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5013
73812303|NCT00772005|147174372|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7330
73812304|NCT00772005|147174372|SUPERIORITY_OR_OTHER|||||||0.0068||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0068
73812305|NCT00772005|147174372|SUPERIORITY_OR_OTHER|||||||0.104||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1040
73812306|NCT00772005|147174373|SUPERIORITY_OR_OTHER|||||||0.822||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8220
73812307|NCT00772005|147174373|SUPERIORITY_OR_OTHER|||||||0.0144||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0144
73812308|NCT00772005|147174373|SUPERIORITY_OR_OTHER|||||||0.9464||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9464
73812309|NCT03280225|147174433|OTHER||Odds Ratio (OR)|1.43||||0.302|TWO_SIDED|95.0|0.73|2.82|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans being assigned a coordinator during the 6 month period following implementation compared to eligible Veterans being assigned a coordinator in the 6 month period prior to implementation.||2.82|0.73|.302
73812310|NCT03280225|147174434|OTHER||Odds Ratio (OR)|1.29||||0.226|TWO_SIDED|95.0|0.86|1.93|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans being assigned a provider during the 6 month period following implementation compared to eligible Veterans being assigned a provider in the 6 month period prior to implementation.||1.93|0.86|0.226
73812311|NCT03280225|147174435|OTHER||Odds Ratio (OR)|1.23||||0.199|TWO_SIDED|95.0|0.9|1.7|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans receiving a care evaluation during the 6 month period following implementation compared to eligible Veterans receiving a care evaluation in the 6 month period prior to implementation.||1.70|0.90|0.199
73812312|NCT03280225|147174436|OTHER||Odds Ratio (OR)|1.38||||0.011|TWO_SIDED|95.0|1.08|1.76|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans where outreach was attempted during the 6 month period following implementation compared to eligible Veterans where outreach was attempted in the 6 month period prior to implementation.||1.76|1.08|0.011
73812313|NCT03280225|147174437|SUPERIORITY|||||||0.018|||||||ANOVA|F (4, 158) = 3.08||Program Needs||||.018
73812314|NCT03280225|147174437|SUPERIORITY|||||||0.136|||||||ANOVA|F (4, 158) = 1.78||Training Needs||||.136
73812315|NCT03280225|147174437|SUPERIORITY|Pressure for Change||||||0.812|||||||ANOVA|F (4, 158) = 0.39||||||.812
73812316|NCT03280225|147174437|SUPERIORITY|Staffing||||||0.358|||||||ANOVA|F (4, 158) = 1.10||||||.358
73812317|NCT03280225|147174437|SUPERIORITY|Mission||||||0.748|||||||ANOVA|F (4, 158) = 0.48||||||.748
73812318|NCT03280225|147174437|SUPERIORITY|||||||0.748|||||||ANOVA|F (4, 158) = 0.48||Cohesion||||.748
73812319|NCT03280225|147174437|SUPERIORITY|||||||0.005|||||||ANOVA|F (4, 158) = 3.88||Autonomy||||.005
73896317|NCT02043899|147326036|OTHER|"1. Exact one-sided binomial test of the null hypothesis (p≤90%) using α=0.05 on \[124I\]mIBG PET/CT SIOPEN consensus scores. If this was accepted and the alternative hypothesis rejected, then trial stopped early for futility.~2. If the null hypothesis was rejected, then a one-sided binomial test of the null hypothesis (p≥97%) was performed (α=0.025). If this was accepted and the alternative hypothesis rejected then the trial stopped early for efficacy."|||||<|0.001||||||Overall design has 82% power and an α of 0.03. Total minimum sample size of 100 lesions was calculated based on a single stage A'hern design with p0 = 0.90 and p1 = 0.97. The overall power and α was calculated based on exact binomial probabilities.|Exact one-sided binomial test||||"For the primary endpoint, a sensitivity analysis was also performed on patients with \<20 positive lesions on \[124I\]mIBG PET/CT to test if few patients with large numbers of positive lesions were affecting the results. The results of the sensitivity analysis were consistent with those of the overall analysis.~Secondary efficacy analysis, separate exact one-sided binomial test of the null hypothesis (p≥97%), performed (α=0.025) performed for skeletal and soft tissue lesions."|||<0.001
73812320|NCT03280225|147174437|SUPERIORITY|||||||0.224|||||||ANOVA|F (4, 158) = 1.44||Communication||||.224
73896318|NCT01347580|147326052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8214|TWO_SIDED|95.0|0.799|1.327||pvalue at 0.025 , adjusted for multiple comparisons|Regression, Logistic|||||1.327|0.799|0.8214
73896319|NCT01347580|147326053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.074||||0.6322|TWO_SIDED|95.0|0.801|1.441||P value at 0.025 adjusted for multiple comparisons|Regression, Logistic|||||1.441|0.801|0.6322
73812321|NCT03280225|147174437|SUPERIORITY|||||||0.043|||||||ANOVA|F (4, 158) = 2.52||Stress||||.043
73812322|NCT03280225|147174437|SUPERIORITY|||||||0.096|||||||ANOVA|F (4, 158) = 2.01||Change||||.096
73812323|NCT02431806|147174453|SUPERIORITY||Least Squares (LS) Mean Difference|-0.38||||0.8035|TWO_SIDED|95.0|-3.41|2.64|||Mixed Model Repeated Measures (MMRM)||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||2.64|-3.41|0.8035
73812324|NCT02431806|147174453|SUPERIORITY||LS Mean Difference|0.26||||0.8681|TWO_SIDED|95.0|-2.8|3.31|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||3.31|-2.80|0.8681
73812325|NCT02431806|147174453|SUPERIORITY||LS Mean|-1.47||||0.3439|TWO_SIDED|95.0|-4.52|1.58|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||1.58|-4.52|0.3439
73812326|NCT02431806|147174454|SUPERIORITY||LS Mean Difference|0.02||||0.8788|TWO_SIDED|95.0|-0.25|0.29|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.29|-0.25|0.8788
73812327|NCT02431806|147174454|SUPERIORITY||LS Mean Difference|0.01||||0.923|TWO_SIDED|95.0|-0.26|0.29|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.29|-0.26|0.9230
73812328|NCT02431806|147174454|SUPERIORITY||LS Mean Difference|-0.15||||0.2895|TWO_SIDED|95.0|-0.42|0.13|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.13|-0.42|0.2895
73812329|NCT02923245|147174477|OTHER||Mean Difference (Final Values)|49.7|||||TWO_SIDED|95.0|23.4|77.2|||||These confidence intervals correspond to the bootstrap analysis|||77.2|23.4|
73812330|NCT02923245|147174478|OTHER||Difference in percentages|15.3||||0.006|TWO_SIDED|95.0|5.3|25.0|||Test of proportions|||||25.0|5.3|0.006
73812331|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|TWO_SIDED|95.0|-3.3|3.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 1||3.0|-3.3|< 0.001
73812332|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|24.2|||<|0.001|TWO_SIDED|95.0|18.7|30.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar|Type 3||30.0|18.7|< 0.001
73812333|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|3.0|||<|0.001|TWO_SIDED|95.0|0.0|6.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 4||6.4|0.0|< 0.001
73812334|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.5|||<|0.001|TWO_SIDED|95.0|-3.9|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 5||2.8|-3.9|< 0.001
73812335|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-5.6|||<|0.001|TWO_SIDED|95.0|-10.0|-1.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6A||-1.6|-10.0|< 0.001
73812336|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-5.7|4.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6B||4.0|-5.7|< 0.001
73812337|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.7|||<|0.001|TWO_SIDED|95.0|-1.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 7F||2.7|-1.1|< 0.001
73812338|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.3|||<|0.001|TWO_SIDED|95.0|-1.9|4.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 9V||4.6|-1.9|< 0.001
73812339|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|TWO_SIDED|95.0|-0.2|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 14||4.7|-0.2|< 0.001
73812340|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.2|||<|0.001|TWO_SIDED|95.0|-2.1|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 18C||4.7|-2.1|< 0.001
73812341|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.9|2.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19A||2.6|-1.9|< 0.001
73812342|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.0|1.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19F||1.9|-1.0|< 0.001
73812343|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.8|||<|0.001|TWO_SIDED|95.0|-2.9|6.5|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 23F||6.5|-2.9|< 0.001
73812344|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|TWO_SIDED|95.0|-2.0|3.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 1||3.9|-2.0|< 0.001
73812345|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|22.3|||<|0.001|TWO_SIDED|95.0|16.5|28.3|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 3||28.3|16.5|< 0.001
73812346|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.9|||<|0.001|TWO_SIDED|95.0|-1.4|5.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 4||5.4|-1.4|< 0.001
73812347|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|TWO_SIDED|95.0|-4.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 5||2.7|-4.1|< 0.001
73812348|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|TWO_SIDED|95.0|-4.2|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6A||2.8|-4.2|< 0.001
73812349|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|TWO_SIDED|95.0|-3.7|5.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6B||5.6|-3.7|< 0.001
73812350|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.7|2.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 7F||2.4|-1.7|< 0.001
73812351|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|TWO_SIDED|95.0|-1.1|5.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 9V||5.2|-1.1|< 0.001
73812352|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.2|||<|0.001|TWO_SIDED|95.0|-2.8|3.1|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 14||3.1|-2.8|< 0.001
73812353|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.6|||<|0.001|TWO_SIDED|95.0|-0.3|5.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 18C||5.9|-0.3|< 0.001
73812354|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|TWO_SIDED|95.0|-2.5|2.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19A||2.2|-2.5|< 0.001
73812355|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-2.9|0.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19F||0.9|-2.9|< 0.001
73812356|NCT02987972|147174509|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|4.2|||<|0.001|TWO_SIDED|95.0|-0.1|8.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 23F||8.7|-0.1|< 0.001
73812357|NCT02987972|147174510|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.81|0.64|
73812358|NCT02987972|147174510|OTHER||GMC Ratio|1.98|||||TWO_SIDED|95.0|1.75|2.23|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.23|1.75|
73812359|NCT02987972|147174510|OTHER||GMC Ratio|1.04|||||TWO_SIDED|95.0|0.92|1.16|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.16|0.92|
73896320|NCT01347580|147326054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.027||||0.9056|TWO_SIDED|95.0|0.661|1.595|||Regression, Logistic|||||1.595|0.661|0.9056
73812360|NCT02987972|147174510|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.89|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.89|0.68|
73812361|NCT02987972|147174510|OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.47|0.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.63|0.47|
73812362|NCT02987972|147174510|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.84|1.26|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.26|0.84|
73812363|NCT02987972|147174510|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.92|0.73|
73812364|NCT02987972|147174510|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.77|1.0|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||1.00|0.77|
73812365|NCT02987972|147174510|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.03|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||1.03|0.75|
73812366|NCT02987972|147174510|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.66|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||0.84|0.66|
73812367|NCT02987972|147174510|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.92|0.73|
73812368|NCT02987972|147174510|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.98|0.79|
73812369|NCT02987972|147174510|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.13|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.13|0.84|
73812370|NCT02987972|147174510|OTHER||GMC Ratio|92.05|||||TWO_SIDED|95.0|80.84|104.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||104.81|80.84|
73896321|NCT01347580|147326055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.215||||0.4168|TWO_SIDED|95.0|0.76|1.942|||Regression, Logistic|||||1.942|0.760|0.4168
73812371|NCT02987972|147174510|OTHER||GMC Ratio|34.41|||||TWO_SIDED|95.0|28.5|41.54|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||41.54|28.50|
73812372|NCT02987972|147174510|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.74|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.94|0.74|
73812373|NCT02987972|147174510|OTHER||GMC Ratio|1.93|||||TWO_SIDED|95.0|1.71|2.18|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.18|1.71|
73812374|NCT02987972|147174510|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.14|0.90|
73812375|NCT02987972|147174510|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.94|0.72|
73812376|NCT02987972|147174510|OTHER||GMC Ratio|0.57|||||TWO_SIDED|95.0|0.49|0.66|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.66|0.49|
73812377|NCT02987972|147174510|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.1|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.10|0.74|
73812378|NCT02987972|147174510|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.72|0.91|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.91|0.72|
73812379|NCT02987972|147174510|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.94|1.22|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||1.22|0.94|
73812380|NCT02987972|147174510|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.71|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.97|0.71|
73812381|NCT02987972|147174510|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.88|1.12|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.12|0.88|
73812382|NCT02987972|147174510|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.92|0.73|
73812383|NCT02987972|147174510|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.81|1.01|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.01|0.81|
73812384|NCT02987972|147174510|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.01|1.37|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.37|1.01|
73812385|NCT02987972|147174510|OTHER||GMC Ratio|80.09|||||TWO_SIDED|95.0|70.3|91.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||91.24|70.30|
73812386|NCT02987972|147174510|OTHER||GMC Ratio|32.92|||||TWO_SIDED|95.0|27.25|39.78|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||39.78|27.25|
73812387|NCT02987972|147174511|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-3.1|3.2||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||3.2|-3.1|
73812388|NCT02987972|147174511|OTHER||Difference in Percentages|2.0|||||TWO_SIDED|95.0|-0.7|5.0||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||5.0|-0.7|
73812389|NCT02987972|147174512|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||1.6|-0.8|
73812390|NCT02987972|147174512|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||1.6|-0.8|
73812391|NCT02987972|147174513|OTHER||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-0.3|12.8|||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.|||12.8|-0.3|
73812392|NCT02987972|147174513|OTHER||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-0.2|12.9|||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.|||12.9|-0.2|
73812393|NCT02987972|147174514|OTHER||Difference in Percentages|0.7||||0.772|TWO_SIDED|95.0|-3.9|5.2|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.|||5.2|-3.9|0.772
73812394|NCT02987972|147174514|OTHER||Difference in Percentages|2.6||||0.235|TWO_SIDED|95.0|-1.7|7.0|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.|||7.0|-1.7|0.235
73812395|NCT02987972|147174515|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.62|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.76|0.62|
73812396|NCT02987972|147174515|OTHER||GMC Ratio|2.0|||||TWO_SIDED|95.0|1.75|2.28|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.28|1.75|
73812397|NCT02987972|147174515|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.86|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.07|0.86|
73812398|NCT02987972|147174515|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.78|0.96|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.96|0.78|
73812399|NCT02987972|147174515|OTHER||GMC Ratio|0.57|||||TWO_SIDED|95.0|0.5|0.65|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.65|0.50|
73812400|NCT02987972|147174515|OTHER||GMC Ratio|1.21|||||TWO_SIDED|95.0|1.06|1.39|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.39|1.06|
73812401|NCT02987972|147174515|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.82|0.67|
73812402|NCT02987972|147174515|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.95|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.95|0.74|
73812403|NCT02987972|147174515|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.76|0.58|
73812404|NCT02987972|147174515|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9||||||Type 18C|IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|0.90|0.72|
73812405|NCT02987972|147174515|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.69|0.91|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.91|0.69|
73812406|NCT02987972|147174515|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.65|0.85|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.85|0.65|
73812407|NCT02987972|147174515|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.07|0.79|
73812408|NCT02987972|147174515|OTHER||GMC Ratio|27.82|||||TWO_SIDED|95.0|24.64|31.4|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|type 22F||31.40|24.64|
73812409|NCT02987972|147174515|OTHER||GMC Ratio|25.57|||||TWO_SIDED|95.0|22.61|28.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||28.92|22.61|
73812410|NCT02987972|147174515|OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.69|0.85|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.85|0.69|
73896322|NCT01347580|147326056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.189||||0.0307|TWO_SIDED|95.0|0.042|0.856|||Regression, Logistic|||||0.856|0.042|0.0307
73812411|NCT02987972|147174515|OTHER||GMC Ratio|2.1|||||TWO_SIDED|95.0|1.84|2.39|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.39|1.84|
73896323|NCT01347580|147326057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.132||||0.344|TWO_SIDED|95.0|0.876|1.462|||Regression, Logistic|||||1.462|0.876|0.344
73896324|NCT01347580|147326058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.225||||0.0547|TWO_SIDED|95.0|0.996|1.506|||Regression, Logistic|||||1.506|0.996|0.0547
73812412|NCT02987972|147174515|OTHER||GMC Ratio|0.94|||||TWO_SIDED|95.0|0.85|1.05|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.05|0.85|
73812413|NCT02987972|147174515|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.77|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.95|0.77|
73812414|NCT02987972|147174515|OTHER||GMC Ratio|0.65|||||TWO_SIDED|95.0|0.57|0.74|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.74|0.57|
73812415|NCT02987972|147174515|OTHER||GMC Ratio|1.12|||||TWO_SIDED|95.0|0.97|1.28|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.28|0.97|
73812416|NCT02987972|147174515|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.7|0.86|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.86|0.70|
73812417|NCT02987972|147174515|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.76|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.97|0.76|
73812418|NCT02987972|147174515|OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.53|0.7|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.70|0.53|
73812419|NCT02987972|147174515|OTHER||GMC Ratio|1.2|||||TWO_SIDED|95.0|1.07|1.34|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.34|1.07|
73812420|NCT02987972|147174515|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.71|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.94|0.71|
73812421|NCT02987972|147174515|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.73|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.94|0.73|
73812422|NCT02987972|147174515|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|0.99|1.35|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.35|0.99|
73896325|NCT01347580|147326059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.803||||0.166|TWO_SIDED|95.0|0.588|1.096|||Regression, Logistic|||||1.096|0.588|0.1660
73812423|NCT02987972|147174515|OTHER||GMC Ratio|26.3|||||TWO_SIDED|95.0|23.31|29.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||29.68|23.31|
73812424|NCT02987972|147174515|OTHER||GMC Ratio|24.1|||||TWO_SIDED|95.0|21.32|27.25|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||27.25|21.32|
73812425|NCT02987972|147174516|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.81|0.62|
73812426|NCT02987972|147174516|OTHER||GMC Ratio|1.44|||||TWO_SIDED|95.0|1.27|1.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||1.63|1.27|
73812427|NCT02987972|147174516|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.02|0.76|
73812428|NCT02987972|147174516|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.84|0.63|
73812429|NCT02987972|147174516|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.82|0.62|
73812430|NCT02987972|147174516|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.22|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.22|0.93|
73812431|NCT02987972|147174516|OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.59|0.77|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.77|0.59|
73812432|NCT02987972|147174516|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.79|0.60|
73812433|NCT02987972|147174516|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||1.02|0.76|
73812434|NCT02987972|147174516|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.08|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.08|0.81|
73812435|NCT02987972|147174516|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.01|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||1.01|0.78|
73812436|NCT02987972|147174516|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.10|0.85|
73812437|NCT02987972|147174516|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.64|0.87|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||0.87|0.64|
73812438|NCT02987972|147174516|OTHER||GMC Ratio|149.69|||||TWO_SIDED|95.0|130.23|172.06|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||172.06|130.23|
73812439|NCT02987972|147174516|OTHER||GMC Ratio|90.35|||||TWO_SIDED|95.0|79.93|102.12|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||102.12|79.93|
73812440|NCT02987972|147174516|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.93|0.71|
73812441|NCT02987972|147174516|OTHER||GMC Ratio|1.48|||||TWO_SIDED|95.0|1.31|1.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||1.68|1.31|
73812442|NCT02987972|147174516|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||0.94|0.70|
73812443|NCT02987972|147174516|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.79|0.60|
73812444|NCT02987972|147174516|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.76|0.58|
73812445|NCT02987972|147174516|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||0.95|0.72|
73812446|NCT02987972|147174516|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.81|0.62|
73812447|NCT02987972|147174516|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.88|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.88|0.67|
73812448|NCT02987972|147174516|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.73|0.98|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.98|0.73|
73812449|NCT02987972|147174516|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.24|0.93|
73812450|NCT02987972|147174516|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.93|0.72|
73812451|NCT02987972|147174516|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.03|0.79|
73812452|NCT02987972|147174516|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.08|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.08|0.79|
73812453|NCT02987972|147174516|OTHER||GMC Ratio|131.23|||||TWO_SIDED|95.0|114.05|151.0|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||151.00|114.05|
73812454|NCT02987972|147174516|OTHER||GMC Ratio|78.99|||||TWO_SIDED|95.0|69.82|89.36|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||89.36|69.82|
73812455|NCT05072106|147174547|OTHER|Bioequivalence|Least-squares geometric mean ratio|96.83|||||TWO_SIDED|90.0|81.09|115.62|||||The reported results are the same as the ones reported in the CSR of the trial.|||115.62|81.09|
73812456|NCT05072106|147174548|OTHER|Bioequivalence|Least-squares geometric mean ratio|79.81|||||TWO_SIDED|90.0|64.78|98.32||||||||98.32|64.78|
73812457|NCT05072106|147174549|OTHER|Bioequivalence|Least-squares geometric mean ratio|79.2|||||TWO_SIDED|90.0|64.12|97.82||||||||97.82|64.12|
73812458|NCT05072106|147174550|OTHER|Bioequivalence|Least-squares geometric mean ratio|125.3|||||TWO_SIDED|90.0|101.71|154.36||||||||154.36|101.71|
73812459|NCT05072106|147174551|OTHER|Bioequivalence|Least-squares geometric mean ratio|106.79|||||TWO_SIDED|90.0|74.63|152.8||||||||152.8|74.63|
73812460|NCT05072106|147174552|OTHER|Bioequivalence|Least-squares geometric mean ratio|104.93|||||TWO_SIDED|90.0|69.49|158.44||||||||158.44|69.49|
73812461|NCT05072106|147174553|OTHER|bioequivalence|Least-squares geometric mean ratio|88.44|||||TWO_SIDED|90.0|65.62|119.19||||||||119.19|65.62|
73812462|NCT05072106|147174554|OTHER|bioequivalence|Least-squares geometric mean ratio|81.8|||||TWO_SIDED|90.0|54.8|119.96||||||||119.96|54.8|
73812463|NCT05072106|147174555|OTHER|bioequivalence|Least-squares geometric mean ratio|80.26|||||TWO_SIDED|90.0|54.26|118.72||||||||118.72|54.26|
73812464|NCT05072106|147174556|OTHER|bioequivalence|Least-squares geometric mean ratio|123.34|||||TWO_SIDED|90.0|83.36|182.49||||||||182.49|83.36|
73812465|NCT05072106|147174557|OTHER|bioequivalence|Least-squares geometric mean ratio|120.5|||||TWO_SIDED|90.0|64.79|224.13||||||||224.13|64.79|
73812466|NCT05072106|147174558|OTHER|bioequivalence|Least-squares geometric mean ratio|120.5|||||TWO_SIDED|90.0|64.79|224.13||||||||224.13|64.79|
73812467|NCT05072106|147174559|OTHER|bioequivalence|Least-squares geometric mean ratio|188.13|||||TWO_SIDED|90.0|132.93|266.26||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M1 dose-normalized Cmax.||266.26|132.93|
73812468|NCT05072106|147174560|OTHER|bioequivalence|Least-squares geometric mean ratio|245.46|||||TWO_SIDED|90.0|133.4|451.65||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M1 dose-normalized AUC0-t.||451.65|133.4|
73812469|NCT05072106|147174561|OTHER|bioequivalence|Least-squares geometric mean ratio|104.94|||||TWO_SIDED|90.0|94.07|117.05||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M4 dose-normalized Cmax.||117.05|94.07|
73812470|NCT05072106|147174562|OTHER|bioequivalence|Least-squares geometric mean ratio|91.02|||||TWO_SIDED|90.0|71.39|116.04||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M4 dose-normalized AUC0-t.||116.04|71.39|
73812471|NCT05175131|147174572|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.0042|TWO_SIDED|95.0|0.3|1.8|||ANCOVA||Mean difference of Mebeverine+Simethicone combination to Mebeverine. Adjusted least squares mean (difference between Mebeverine+Simethicone combination and Mebeverine) from ANCOVA is presented here|ANCOVA was used for primary end point analysis. The model included the change from baseline of the NRS\_11 score as dependent variable and treatment and site as independent factors, and baseline NRS-11 as covariate.||1.8|0.3|0.0042
73812472|NCT05175131|147174572|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.0001|TWO_SIDED|95.0|0.9|2.4|||ANCOVA||Adjusted least squares mean (difference between Mebeverine+Simethicone combination and Mebeverine) from ANCOVA is presented here|Mean difference of Mebeverine+Simethicone combination to Simethicone. ANCOVA was used for primary end point analysis. The model included the change from baseline of the NRS\_11 score as dependent variable and treatment and site as independent factors, and baseline NRS-11 as covariate.||2.4|0.9|<0.0001
73812473|NCT02542293|147174577|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0808|TWO_SIDED|95.0|0.485|1.045||The 2-sided p-value was calculated using an unstratified log-rank test.|Log Rank||The HR and confidence interval (CI) were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"Global: Durvalumab + Tremelimumab versus (Vs) Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.045|0.485|0.0808
73812474|NCT02542293|147174578|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.322|1.109|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.109|0.322|
73812475|NCT02542293|147174579|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.629|1.201|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.201|0.629|
73812476|NCT02542293|147174579|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.726|1.213|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.213|0.726|
73812477|NCT02542293|147174579|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.786|1.464|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.464|0.786|
73812478|NCT02542293|147174579|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.835|1.302|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB \<20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.302|0.835|
73812479|NCT02542293|147174579|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.758|1.353|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB non-evaluable analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.353|0.758|
73812480|NCT02542293|147174579|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.309|1.008|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.008|0.309|
73812481|NCT02542293|147174579|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.56|1.35|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.350|0.560|
73812482|NCT02542293|147174579|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.614|1.251|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.251|0.614|
73812483|NCT02542293|147174579|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.564|1.08|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.080|0.564|
73812484|NCT02542293|147174580|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.871|1.186|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.186|0.871|
73812485|NCT02542293|147174580|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.018|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25 and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.018|0.480|
73812486|NCT02542293|147174580|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.654|1.078|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.078|0.654|
73812487|NCT02542293|147174580|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.289|1.065|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.065|0.289|
73812488|NCT02542293|147174580|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.587|1.081|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.081|0.587|
73812489|NCT02542293|147174580|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.222|0.955|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||0.955|0.222|
73812490|NCT02542293|147174581|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.514|1.146|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.146|0.514|
73812491|NCT02542293|147174581|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.623|1.189|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.189|0.623|
73812492|NCT02542293|147174581|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.714|1.193|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.193|0.714|
73812493|NCT02542293|147174581|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.258|0.818|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||0.818|0.258|
73812494|NCT02542293|147174581|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.524|1.228|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.228|0.524|
73812495|NCT02542293|147174581|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.585|1.177|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.177|0.585|
73812496|NCT02542293|147174581|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.534|1.017|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.017|0.534|
73812497|NCT02542293|147174582|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.81|1.517|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.517|0.810|
73812498|NCT02542293|147174582|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.592|2.141|||||The HR and CI interval were calculated using an stratified Cox proportional hazards model, adjusting histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||2.141|0.592|
73812499|NCT02542293|147174582|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.924|1.253|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.253|0.924|
73812500|NCT02542293|147174582|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.655|1.362|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥ 25% Vs \< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.362|0.655|
73812501|NCT02542293|147174582|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.621|1.024|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.024|0.621|
73812502|NCT02542293|147174582|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.389|1.317|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.317|0.389|
73812503|NCT02542293|147174582|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.542|1.01|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.010|0.542|
73812504|NCT02542293|147174582|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.335|1.251|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.251|0.335|
73812505|NCT02542293|147174583|SUPERIORITY||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.236|1.03||||||"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.030|0.236|
73812506|NCT02542293|147174583|SUPERIORITY||Odds Ratio (OR)|0.53|||||TWO_SIDED|95.0|0.288|0.968||||||"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.968|0.288|
73812507|NCT02542293|147174583|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.336|0.908||||||"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.908|0.336|
73812508|NCT02542293|147174583|SUPERIORITY||Odds Ratio (OR)|1.96|||||TWO_SIDED|95.0|0.752|5.234||||||"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||5.234|0.752|
73812509|NCT02542293|147174583|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.482|2.214||||||"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||2.214|0.482|
73812510|NCT02542293|147174583|SUPERIORITY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.43|1.548||||||"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.548|0.430|
73812511|NCT02542293|147174583|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.456|1.486||||||"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.486|0.456|
73812512|NCT02542293|147174584|SUPERIORITY||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.245|0.869|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.869|0.245|
73812513|NCT02542293|147174584|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.124|1.337|||Binomial exact test|||"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.337|0.124|
73812514|NCT02542293|147174584|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.356|0.647|||||The analysis was performed using logistic regression adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.647|0.356|
73812515|NCT02542293|147174584|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.45|1.66|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.660|0.450|
73812516|NCT02542293|147174584|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.443|1.079|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.079|0.443|
73812517|NCT02542293|147174584|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|1.78|||||TWO_SIDED|95.0|0.658|4.919|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||4.919|0.658|
73812518|NCT02542293|147174584|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.449|1.291|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.291|0.449|
73812519|NCT02542293|147174584|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.585|5.27|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||5.270|0.585|
73812520|NCT02542293|147174585|SUPERIORITY||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.113|0.532|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.532|0.113|
73812521|NCT02542293|147174585|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.196|0.639|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.639|0.196|
73812522|NCT02542293|147174585|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.233|0.611|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.611|0.233|
73812523|NCT02542293|147174586|SUPERIORITY||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.199|0.787|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.787|0.199|
73812524|NCT02542293|147174586|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.183|2.86|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||2.860|0.183|
73812525|NCT02542293|147174586|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.324|0.588|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.588|0.324|
73812526|NCT02542293|147174586|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.193|0.761|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.761|0.193|
73812527|NCT02542293|147174589|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.494|1.058|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.058|0.494|
73812528|NCT02542293|147174589|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.607|1.151|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.151|0.607|
73812529|NCT02542293|147174589|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.689|1.146|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.146|0.689|
73812530|NCT02542293|147174590|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.748|1.388|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.388|0.748|
73812531|NCT02542293|147174590|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.36|1.219|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.219|0.360|
73812532|NCT02542293|147174590|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.845|1.147|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.147|0.845|
73812533|NCT02542293|147174590|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.492|1.03|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.030|0.492|
73812534|NCT00310466|147174597|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||||||0.87
73812535|NCT00310466|147174598|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
73812536|NCT00310466|147174600|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANOVA|||||||0.55
73812537|NCT01458951|147174601|SUPERIORITY_OR_OTHER||Percentage difference|13.0||||0.0005|TWO_SIDED|95.0|8.1|17.9|||CMH Chi-square Test|||P-value based on Cochran-Mantel Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using non-responder imputation (NRI).||17.9|8.1|0.0005
73812538|NCT01458951|147174602|SUPERIORITY_OR_OTHER||Percentage difference|16.8||||0.0002|TWO_SIDED|95.0|9.5|24.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.1|9.5|0.0002
73812539|NCT01458951|147174603|SUPERIORITY_OR_OTHER||Percentage difference|26.4|||<|0.0001|TWO_SIDED|95.0|16.8|36.0|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||36.0|16.8|<0.0001
73812540|NCT01458951|147174604|SUPERIORITY_OR_OTHER||Percentage difference|5.2||||0.0425|TWO_SIDED|95.0|1.8|8.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.6|1.8|0.0425
73812541|NCT01458951|147174605|SUPERIORITY_OR_OTHER||Difference in percentage|13.2||||0.0004|TWO_SIDED|95.0|8.3|18.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference in its percentage and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.1|8.3|0.0004
73812542|NCT01458951|147174606|SUPERIORITY_OR_OTHER||Percentage difference|8.0||||0.009|TWO_SIDED|95.0|3.9|12.2|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||12.2|3.9|0.0090
73812543|NCT01458951|147174607|SUPERIORITY_OR_OTHER||Percentage difference|3.3||||0.1408|TWO_SIDED|95.0|0.1|6.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||6.6|0.1|0.1408
73812544|NCT01458951|147174609|SUPERIORITY_OR_OTHER||Least square mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.6|-1.4|<0.0001
73812545|NCT01458951|147174609|SUPERIORITY_OR_OTHER||Least square mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Models Analysis|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.7|-1.6|<0.0001
73812546|NCT01458951|147174609|SUPERIORITY_OR_OTHER||Least square mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Models Analysis|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.9|-1.7|<0.0001
73812547|NCT01458951|147174610|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.2|-1.0|||ANCOVA|||The change from baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.||-1.0|-2.2|<0.0001
73812548|NCT00585013|147174611|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This p value applies to all time points for all variables.|Wilcoxon (Mann-Whitney)|||||||>0.05
73812549|NCT00585013|147174612|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This applies for measurements at preoperative and 0 h time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
73812550|NCT00585013|147174612|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This applies to measurements at time points 12 h, 24 h, and 48 h.|Wilcoxon (Mann-Whitney)|||||||<0.05
73812551|NCT00585013|147174613|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This applies to measurements at preoperative, 0 h, and 48 h time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
73812552|NCT00585013|147174613|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This applies to time points at 12 h and 24 h.|Wilcoxon (Mann-Whitney)|||||||<0.05
73812553|NCT00585013|147174614|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Applies to all time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
73812554|NCT01573767|147174637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.227|TWO_SIDED|95.0|-2.7|11.4||Inference for VI 12.5 µg versus (vs) placebo was dependent upon statistical significance (SS) having first been achieved for VI 25 µg vs placebo; inference for VI 6.25 µg vs placebo was dependent on SS having been achieved for VI 12.5 µg vs placebo.|ANCOVA|||||11.4|-2.7|0.227
73812555|NCT01573767|147174637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.073|TWO_SIDED|95.0|-0.6|13.5|||ANCOVA|||||13.5|-0.6|0.073
73812556|NCT01573767|147174637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5||||0.127|TWO_SIDED|95.0|-1.6|12.5|||ANCOVA|||||12.5|-1.6|0.127
73812557|NCT01573767|147174638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057|||||TWO_SIDED|95.0|-0.138|0.024||||||||0.024|-0.138|
73812558|NCT01573767|147174638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.063|0.096||||||||0.096|-0.063|
73812559|NCT01573767|147174638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.11|0.051||||||||0.051|-0.110|
73812560|NCT01573767|147174639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-10.5|6.0||||||||6.0|-10.5|
73812561|NCT01573767|147174639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-6.9|9.6||||||||9.6|-6.9|
73812562|NCT01573767|147174639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|0.4|17.0||||||||17.0|0.4|
73812563|NCT01573767|147174640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0|-1.2|12.3||||||||12.3|-1.2|
73812564|NCT01573767|147174640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|0.7|14.2||||||||14.2|0.7|
73812565|NCT01573767|147174640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2||||||95.0|0.4|14.0||||||||14.0|0.4|
73812566|NCT01573767|147174641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-6.1|13.1||||||||13.1|-6.1|
73812567|NCT01573767|147174641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-1.8|17.4||||||||17.4|-1.8|
73812568|NCT01573767|147174641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|||||TWO_SIDED|95.0|-4.4|14.9||||||||14.9|-4.4|
73812569|NCT01573767|147174642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-3.7|15.6||||||||15.6|-3.7|
73812570|NCT01573767|147174642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|||||TWO_SIDED|95.0|0.0|19.3||||||||19.3|0.0|
73812571|NCT01573767|147174642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||||95.0|-2.7|16.7||||||||16.7|-2.7|
73812572|NCT01573767|147174643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-7.2|7.5||||||||7.5|-7.2|
73812573|NCT01573767|147174643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3|||||TWO_SIDED|95.0|1.0|15.7||||||||15.7|1.0|
73812574|NCT01573767|147174643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|2.3|17.2||||||||17.2|2.3|
73812575|NCT00869557|147174649|NON_INFERIORITY_OR_EQUIVALENCE|"A total sample size of 75 participants randomized in a 2:1 ratio had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 84% for both treatment groups and a noninferiority margin of 0.12 were assumed.~A total of 71 participants were enrolled in the study (4 fewer than planned)."|Difference in the response rates (%)|2.8|||||TWO_SIDED|95.0|-14.5|20.1|||||The 95% confidence interval was computed using normal approximation stratified by baseline HIV-1 RNA stratum (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the response rate (proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 24) in the Stribild group was at least 12% worse than the response rate in Atripla group; the alternative hypothesis was that the response rate in the Stribild group was less than 12% worse than that in the Atripla group.||20.1|-14.5|
73812576|NCT02102100|147174655|OTHER||Mean Difference (Net)|0.9436|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Least square means and standard errors were calculated to describe the patterns of means for each outcome. Effect slices were tested to explain significant interactions in the models. Pairwise comparisons of least square means were used to describe significant main effects.||||<.0001
73812577|NCT03747302|147174688|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
73812578|NCT03747302|147174689|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||Change in mean scores for behavioral intent to vaccine: negative values: smaller values indicate more likely to vaccinate.||||>.05
73812579|NCT00628095|147174714|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0221||||0.591|TWO_SIDED|90.0|-0.17|0.13|||Normal Approximation method|No adjustments for multiple comparisons were performed.|Power of 80% and a Type I error at 0.10 in a 1-sided test was calculated. Null hypothesis stated that there was no difference between the CE-224,535 and placebo arm groups, on the percentage of ACR 20 responders at Week 12.|Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.13|-0.17|0.591
73812580|NCT00628095|147174715|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.1232||||0.941|TWO_SIDED|80.0|-0.22|-0.02|||Normal Approximation method|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||-0.02|-0.22|0.941
73812581|NCT00628095|147174715|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0622||||0.742|TWO_SIDED|80.0|-0.18|0.05|||Normal Approximation method|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.05|-0.18|0.742
73812582|NCT00628095|147174715|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.004||||0.482|TWO_SIDED|80.0|-0.11|0.12|||Normal Approximation method|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.12|-0.11|0.482
73812583|NCT00628095|147174716|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0072||||0.989|TWO_SIDED|80.0|-0.08|0.06|||Barnard exact test|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.06|-0.08|0.989
73812584|NCT00628095|147174716|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0096||||0.957|TWO_SIDED|80.0|-0.08|0.07|||Barnard exact test|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.07|-0.08|0.957
73812585|NCT00628095|147174716|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0044||||0.473|TWO_SIDED|80.0|-0.08|0.09|||Normal Approximation method|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.09|-0.08|0.473
73812586|NCT00628095|147174716|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.057||||0.793|TWO_SIDED|80.0|-0.15|0.03|||Normal Approximation method|||Week 12: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.03|-0.15|0.793
73812587|NCT00628095|147174717|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0377||||0.121|TWO_SIDED|80.0|0.0|0.09|||Barnard exact test|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.09|-0.00|0.121
73812588|NCT00628095|147174717|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0141||||0.421|TWO_SIDED|80.0|-0.05|0.07|||Barnard exact test|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.07|-0.05|0.421
73812589|NCT00628095|147174717|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0566||||0.058|TWO_SIDED|80.0|0.01|0.12|||Barnard exact test|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.12|0.01|0.058
73812590|NCT00628095|147174717|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0377||||0.121|TWO_SIDED|80.0|0.0|0.09|||Barnard exact test|||Week 12: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.09|-0.00|0.121
73812591|NCT00628095|147174725|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 2: p-value was analyzed using Barnard Exact Test.||||1.0000
73812592|NCT00628095|147174725|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 4: p-value was analyzed using Barnard Exact Test.||||1.0000
73812593|NCT00628095|147174725|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 8: p-value was analyzed using Barnard Exact Test.||||1.0000
73812594|NCT00628095|147174725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED||||||Barnard exact test|||Week 12: p-value was analyzed using Barnard Exact Test.||||0.0637
73812595|NCT00628095|147174725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED||||||Barnard exact test|||Week 14: p-value was analyzed using Barnard Exact Test.||||0.0637
73812596|NCT00006305|147174738|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.005||||0.97|TWO_SIDED|95.0|-0.031|0.02||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Revascularization compared with Medical therapy|||0.020|-0.031|0.97
73812597|NCT00006305|147174738|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.003||||0.89|TWO_SIDED|95.0|-0.029|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy|||0.022|-0.029|0.89
73812598|NCT00006305|147174739|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.013||||0.7|TWO_SIDED|95.0|-0.049|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Revascularization compared with Medical Therapy|||0.022|-0.049|0.70
73812599|NCT00006305|147174739|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.024||||0.13||95.0|-0.06|0.012||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy|||0.012|-0.060|0.13
73812600|NCT01928797|147174740|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
73812601|NCT01928797|147174741|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
73812602|NCT00662558|147174743|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Differences in treatment proportions and the 95% confidence interval (CI) around the difference were estimated by calculating the risk difference between the treatment arms using a generalized linear model with treatment and center as factors. A lower 95% CI for the risk difference greater than -0.10 would demonstrate that celecoxib 200 mg BID is not inferior to tramadol hydrochloride 50 mg QID.|Risk Difference (RD)|0.091||||||95.0|0.0255|0.1565||||||||0.1565|0.0255|
73812603|NCT00662558|147174743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0|||||Cochran-Mantel-Haenszel|||If celecoxib 200 mg BID was found to be non-inferior to tramadol hydrochloride 50 mg QID then the second step was to test the superiority of celecoxib 200 mg BID over tramadol hydrochloride 50 mg QID using a two-sided test of proportions. Differences in proportions were tested using the General Association Test of the Cochran-Mantel-Haenszel (CMH) procedure stratified by center.||||0.008
73812604|NCT00662558|147174744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.234||95.0|-0.53|0.13|||ANCOVA||The mean difference reported is the least squares (LS) mean difference.|The change from Baseline was compared between the two treatment groups using analysis of covariance (ANCOVA), with treatment and center as factors, and Baseline value as a covariate.||0.13|-0.53|0.234
73812605|NCT00662558|147174745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.76||0.595||95.0|-4.39|2.52|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||2.52|-4.39|0.595
73812606|NCT00662558|147174746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.829||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.829
73812607|NCT00662558|147174747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.470
73812608|NCT00662558|147174748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.32||0.339||95.0|-0.95|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.95|0.339
73812609|NCT00662558|147174749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.741||95.0|-0.36|0.25|||ANCOVA||The mean difference reported is the LS mean difference.|How Much Pain Now. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.25|-0.36|0.741
73812610|NCT00662558|147174749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.17||0.796||95.0|-0.38|0.29|||ANCOVA||The mean difference reported is the LS mean difference.|Worst Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.29|-0.38|0.796
73812611|NCT00662558|147174749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.16||0.492||95.0|-0.41|0.2|||ANCOVA||The mean difference reported is the LS mean difference.|Average Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.20|-0.41|0.492
73812612|NCT00662558|147174749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.893||95.0|-0.28|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With General Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.28|0.893
73812613|NCT00662558|147174749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.618||95.0|-0.4|0.24|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Mood. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.24|-0.40|0.618
73812614|NCT00662558|147174749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.44||95.0|-0.19|0.43|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Walking Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.43|-0.19|0.440
73812615|NCT00662558|147174749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.806||95.0|-0.25|0.32|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Relations With Others. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.32|-0.25|0.806
73812616|NCT00662558|147174749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.17||0.739||95.0|-0.38|0.27|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.27|-0.38|0.739
73812617|NCT00662558|147174749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.992||95.0|-0.32|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Normal Work. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.32|0.992
73812618|NCT00662558|147174749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.793||95.0|-0.28|0.36|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Enjoyment of Life. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.36|-0.28|0.793
73812619|NCT00662558|147174749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.973||95.0|-0.27|0.28|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interference Subscale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.28|-0.27|0.973
73812620|NCT00662558|147174750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|1.51||0.392||95.0|-4.26|1.67|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Disturbance. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.67|-4.26|0.392
73896326|NCT01248104|147326064|SUPERIORITY_OR_OTHER_LEGACY|Continuous variables were compared by multivariate linear regression analysis to adjust for possible covariates of intraoperative fluids, age, bypass time, and procedure time. Tukey-Kramer test was then used to compare for specific differences between groups for each variable. Categorical data were compared using Fisher's exact test. All comparisons were made at a significance level of 0.05, and analysis was performed with Minitab version 17).||||||0.35||||||The primary outcome measure showed that there was no difference in PRBC transfusion frequency or amounts in the operating room or the in ICU up to POD 2|ANOVA|||A power analysis based on the comparison of a 15% difference in total transfusion amounts up to POD 2 between the treatment groups indicated a total sample size of 80 with a power of 0.8, confidence interval 0.9, and p= 0.05.||||0.35
73812621|NCT00662558|147174750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.67||0.691||95.0|-3.94|2.61|||ANCOVA||The mean difference reported is the LS mean difference.|Snoring. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||2.61|-3.94|0.691
73812622|NCT00662558|147174750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.45||0.549||95.0|-3.7|1.97|||ANCOVA||The mean difference reported is the LS mean difference.|Awaken Shortness of Breath or Headache. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.97|-3.70|0.549
73812623|NCT00662558|147174750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.23||0.336||95.0|-0.67|0.23|||ANCOVA||The mean difference reported is the LS mean difference.|Quantity of Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.23|-0.67|0.336
73812624|NCT00662558|147174750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.69||0.37||95.0|-4.83|1.8|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Adequacy. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.80|-4.83|0.370
73812625|NCT00662558|147174750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|1.34||0.341||95.0|-3.9|1.35|||ANCOVA||The mean difference reported is the LS mean difference.|Somnolence. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.35|-3.90|0.341
73896327|NCT02908490|147326098|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline FMD within that period and a term for treatment order.|Slope|-1.42||||0.185|TWO_SIDED|95.0|-3.54|0.68||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||0.68|-3.54|0.185
73812626|NCT00662558|147174750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.15||0.604||95.0|-2.85|1.66|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index I. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.66|-2.85|0.604
73812627|NCT00662558|147174750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.14||0.547||95.0|-2.92|1.55|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index II. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.55|-2.92|0.547
73812628|NCT00662558|147174751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196||95.0|||||Cochran-Mantel-Haenszel|||Optimal sleep was analyzed using CMH general association test.||||0.196
73812629|NCT00662558|147174752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|1.91||0.252||95.0|-1.56|5.94|||ANCOVA||The mean difference reported is the LS mean difference.|Time Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||5.94|-1.56|0.252
73812630|NCT00662558|147174752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|1.88||0.798||95.0|-3.21|4.17|||ANCOVA||The mean difference reported is the LS mean difference.|Physical Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||4.17|-3.21|0.798
73812631|NCT00662558|147174752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|1.92||0.7||95.0|-3.03|4.51|||ANCOVA||The mean difference reported is the LS mean difference.|Output Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||4.51|-3.03|0.700
73812632|NCT00662558|147174752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|1.72||0.902||95.0|-3.16|3.59|||ANCOVA||The mean difference reported is the LS mean difference.|Mental-Interpersonal Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||3.59|-3.16|0.902
73812633|NCT00662558|147174752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.46||0.581||95.0|-0.65|1.16|||ANCOVA||The mean difference reported is the LS mean difference.|Index Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.16|-0.65|0.581
73812634|NCT00662558|147174753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 1.||||0.614
73812635|NCT00662558|147174753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.786||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 3.||||0.786
73812636|NCT00662558|147174753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 6/ET.||||0.044
73812637|NCT00662558|147174754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.870
73812638|NCT00662558|147174755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.545||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.545
73812639|NCT00662558|147174756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||95.0|||||Cochran-Mantel-Haenszel|||CMH test adjusted for center was used to compare the two treatment groups.||||0.218
73896328|NCT02908490|147326099|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline EndoPAT within that period and a term for treatment order.|Slope|0.2||||0.003|TWO_SIDED|95.0|0.069|0.331||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||0.331|0.069|0.003
73812640|NCT01711619|147174757|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 4% was predefined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation of the proportion for ITT.||||<0.0001
73812641|NCT01711619|147174758|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Regression, Linear|||||||<0.0001
73812642|NCT01711619|147174759|SUPERIORITY_OR_OTHER|||||||0.0002||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.||||0.0002
73812643|NCT01711619|147174760|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.||||<0.0001
73812644|NCT01432275|147174783|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test|Comparison to 27 participants that preferred their usual method to FreeStyle InsuLinx. Twelve(12) participants did not have a preference.||||||<0.0001
73812645|NCT00475878|147174805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64|STANDARD_ERROR_OF_MEAN|0.22||0.19|TWO_SIDED|95.0|0.33|1.24|||Chi-squared|||||1.24|.33|.19
73812646|NCT00475878|147174806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.16||0.18|TWO_SIDED|95.0|-2.79|5.84|||t-test, 2 sided|||||5.84|-2.79|.18
73812647|NCT00231283|147174807|SUPERIORITY_OR_OTHER||Percentage of participants|97.0|STANDARD_ERROR_OF_MEAN|1.71||||95.0|91.5|99.4|||Qualitative Comparison|Reported in qualitative/semi-quantitative comparitive fashion due to study design.||||99.4|91.5|
73812648|NCT00231283|147174808|SUPERIORITY_OR_OTHER||Percentage of participants|3.0||||||95.0|0.6|8.6|||No formal statistical testing|||||8.6|0.6|
73812649|NCT00231283|147174809|SUPERIORITY_OR_OTHER||Percentage of participants|3.0||||||95.0|0.6|8.5|||Descriptive statistics|||||8.5|0.6|
73812650|NCT00231283|147174810|SUPERIORITY_OR_OTHER||Percentage of participants|10.4||||||95.0|5.1|18.3|||Descriptive statistics|||||18.3|5.1|
73812651|NCT02124759|147174838|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|Paired T-test||Null hypothesis is that high fat diet will have no effect on M value, the measure of insulin sensitivity for each intervention as assessed by clamp.||||>0.05
73812652|NCT01785849|147174848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|32.46|||<|0.001|TWO_SIDED|95.0|18.71|56.31|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (\< 600, ≥ 600 to ≤ 1000, and \> 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of proportion of participants with \> 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.||56.31|18.71|<0.001
73812653|NCT01785849|147174849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.08|||<|0.001|TWO_SIDED|95.0|11.47|42.48|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by screening PTH category, recent cinacalcet use within 8 weeks before randomization, and region.||||42.48|11.47|<0.001
73812654|NCT01785849|147174850|SUPERIORITY_OR_OTHER||Mean Difference|-71.11|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-77.77|-64.46|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-64.46|-77.77|<0.001
73812655|NCT01785849|147174851|SUPERIORITY_OR_OTHER||Mean Difference|-8.38|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|TWO_SIDED|95.0|-9.52|-7.23|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-7.23|-9.52|<0.001
73812656|NCT01785849|147174852|SUPERIORITY_OR_OTHER||Mean Difference|-14.99|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-19.73|-10.25|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-10.25|-19.73|<0.001
73812657|NCT01785849|147174853|SUPERIORITY_OR_OTHER||Mean Difference|-7.45|STANDARD_ERROR_OF_MEAN|2.47||0.003|TWO_SIDED|95.0|-12.31|-2.59|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-2.59|-12.31|0.003
73812658|NCT04250298|147174873|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
73812659|NCT04250298|147174874|OTHER|||||||0.267|||||||t-test, 2 sided|||||||0.267
73812660|NCT04250298|147174875|OTHER|||||||0.228|||||||t-test, 2 sided|||||||0.228
73812661|NCT04250298|147174876|OTHER|||||||0.267|||||||t-test, 2 sided|||||||0.267
73812662|NCT04250298|147174877|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
73812663|NCT04250298|147174878|OTHER|||||||0.318|||||||Fisher Exact|||||||0.318
73812664|NCT04250298|147174879|OTHER|||||||0.348|||||||Fisher Exact|||||||0.348
73812665|NCT04250298|147174880|OTHER|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||||||0.548
73812666|NCT04250298|147174881|OTHER|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||||||0.401
73812667|NCT04250298|147174882|OTHER|||||||0.506|||||||Wilcoxon (Mann-Whitney)|||||||0.506
73812668|NCT04250298|147174883|OTHER|||||||0.506|||||||Wilcoxon (Mann-Whitney)|||||||0.506
73812669|NCT04250298|147174889|OTHER|Mann-Whitney U test, Fisher Exact, Chi-Squared, Kolmogorv-Smirnow||||||0.919|||||||Wilcoxon (Mann-Whitney)|||"sub-population 1 vs. sub-population 2: Parametric and nonparametric univariate tests: t-test for independent samples, Mann-Whitney-U test, Fisher's exact test, chi-square homogeneity test; normal distribution check by Kolmogorov-Smirnov test with Lilliefors -significance correction, type I error = 10%).~Estimate the true effect size:~Two-sided 95% confidence intervals (depending on the nature of the data sets: parametric, non-parametric or Clopper-Pearson) are calculated for all parameters."||||0.919
73812670|NCT04250298|147174891|OTHER|||||||0.033|||||||t-test, 2 sided|||||||0.033
73812671|NCT04250298|147174892|OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
73812672|NCT04250298|147174893|OTHER|||||||0.676|||||||t-test, 2 sided|||||||0.676
73812673|NCT04250298|147174894|OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
73812674|NCT04250298|147174899|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
73812675|NCT04250298|147174900|OTHER|||||||0.862|||||||t-test, 2 sided|||||||0.862
73812676|NCT04250298|147174901|OTHER|||||||0.25|||||||Fisher Exact|||||||0.250
73812677|NCT04250298|147174902|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73812678|NCT04250298|147174903|OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
73812679|NCT04250298|147174904|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
73812680|NCT04250298|147174905|OTHER|||||||0.111|||||||Wilcoxon (Mann-Whitney)|||||||0.111
73812681|NCT04250298|147174906|OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
73812682|NCT04250298|147174909|OTHER|||||||0.111|||||||Wilcoxon (Mann-Whitney)|||||||0.111
73812683|NCT04250298|147174910|OTHER|||||||0.213|||||||Wilcoxon (Mann-Whitney)|||||||0.213
73812684|NCT00793624|147174952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.193|0.110|<0.0001
73812685|NCT00793624|147174952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.124|<0.0001
73812686|NCT00793624|147174952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.218|0.136|<0.0001
73812687|NCT00793624|147174953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.021||0.0002||95.0|0.037|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.118|0.037|0.0002
73812688|NCT00793624|147174953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.044|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.125|0.044|<0.0001
73812689|NCT00793624|147174953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.021||0.0088||95.0|0.014|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.095|0.014|0.0088
73812690|NCT00793624|147174954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.343||0.5843||95.0|-0.485|0.86|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.860|-0.485|0.5843
73812691|NCT00793624|147174954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.345||0.9494||95.0|-0.656|0.699|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.699|-0.656|0.9494
73812692|NCT00793624|147174954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.288|STANDARD_ERROR_OF_MEAN|0.346||0.5099||95.0|-0.908|0.451|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.451|-0.908|0.5099
73812693|NCT00793624|147174955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.442|STANDARD_ERROR_OF_MEAN|1.401||0.0816||95.0|-5.19|0.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.307|-5.190|0.0816
73812694|NCT00793624|147174955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.394|STANDARD_ERROR_OF_MEAN|1.4||0.0155||95.0|-6.141|-0.648|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.648|-6.141|0.0155
73812695|NCT00793624|147174955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.952|STANDARD_ERROR_OF_MEAN|1.396||0.4954||95.0|-3.691|1.787|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.787|-3.691|0.4954
73812696|NCT00793624|147174956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.785|STANDARD_ERROR_OF_MEAN|1.387||0.045||95.0|-5.507|-0.063|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.063|-5.507|0.0450
73812697|NCT00793624|147174956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.144|STANDARD_ERROR_OF_MEAN|1.386||0.0002||95.0|-7.864|-2.425|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-2.425|-7.864|0.0002
73812698|NCT00793624|147174956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.754|STANDARD_ERROR_OF_MEAN|1.386||0.2061||95.0|-4.474|0.966|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.966|-4.474|0.2061
73812699|NCT00793624|147174957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.871|STANDARD_ERROR_OF_MEAN|1.419||0.1878||95.0|-4.655|0.914|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.914|-4.655|0.1878
73812700|NCT00793624|147174957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.565|STANDARD_ERROR_OF_MEAN|1.427||0.0126||95.0|-6.364|-0.767|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.767|-6.364|0.0126
73812701|NCT00793624|147174957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|1.426||0.9913||95.0|-2.782|2.814|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||2.814|-2.782|0.9913
73812702|NCT00793624|147174958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.972||0.0034||95.0|-4.751|-0.94|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||-0.940|-4.751|0.0034
73812703|NCT00793624|147174958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.434|STANDARD_ERROR_OF_MEAN|0.973||0.0004||95.0|-5.343|-1.525|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||-1.525|-5.343|0.0004
73812704|NCT00793624|147174958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.248|STANDARD_ERROR_OF_MEAN|0.976||0.2009||95.0|-3.161|0.665|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 10 mcg qd minus Placebo||0.665|-3.161|0.2009
73812705|NCT00793624|147174959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.146|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.226|0.146|<0.0001
73812706|NCT00793624|147174959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.126|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.126|<0.0001
73812707|NCT00793624|147174959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.166|0.246|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.246|0.166|<0.0001
73812708|NCT00793624|147174960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.136|<0.0001
73812709|NCT00793624|147174960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.119|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.119|<0.0001
73812710|NCT00793624|147174960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.152|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.233|0.152|<0.0001
73812711|NCT00793624|147174961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.137|0.219|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.219|0.137|<0.0001
73812712|NCT00793624|147174961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.129|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.211|0.129|<0.0001
73812713|NCT00793624|147174961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.144|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.226|0.144|<0.0001
73812714|NCT00793624|147174962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.103|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.186|0.103|<0.0001
73812715|NCT00793624|147174962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.105|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.188|0.105|<0.0001
73812716|NCT00793624|147174962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.13|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.214|0.130|<0.0001
73812717|NCT00793624|147174963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.048|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.126|0.048|<0.0001
73812718|NCT00793624|147174963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.118|0.040|<0.0001
73812719|NCT00793624|147174963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.040|<0.0001
73812720|NCT00793624|147174964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.047|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.125|0.047|<0.0001
73812721|NCT00793624|147174964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.02||0.0001||95.0|0.038|0.117|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.117|0.038|0.0001
73812722|NCT00793624|147174964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.039|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.039|<0.0001
73812723|NCT00793624|147174965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.043|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|0.043|<0.0001
73896329|NCT02908490|147326105|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|7.63||||0.061|TWO_SIDED|95.0|-0.36|15.63||The a prior threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||15.63|-0.36|0.061
73896330|NCT02908490|147326106|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|55.3||||0.011|TWO_SIDED|95.0|12.79|97.81||The a prior threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||97.81|12.79|0.011
73812724|NCT00793624|147174965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.02||0.0002||95.0|0.035|0.114|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.114|0.035|0.0002
73812725|NCT00793624|147174965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.02||0.0037||95.0|0.019|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.100|0.019|0.0037
73812726|NCT00793624|147174966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.02||0.0016||95.0|0.025|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|0.025|0.0016
73812727|NCT00793624|147174966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.02||0.0276||95.0|0.005|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.085|0.005|0.0276
73812728|NCT00793624|147174966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.021||0.0426||95.0|0.001|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.082|0.001|0.0426
73812729|NCT00793624|147174967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0237||95.0|0.006|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.087|0.006|0.0237
73812730|NCT00793624|147174967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.021||0.0175||95.0|0.009|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.090|0.009|0.0175
73812731|NCT00793624|147174967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.021||0.0339||95.0|0.003|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.085|0.003|0.0339
73812732|NCT00793624|147174968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.021||0.0537||95.0|-0.001|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.081|-0.001|0.0537
73812733|NCT00793624|147174968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.021||0.0808||95.0|-0.004|0.078|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.078|-0.004|0.0808
73812734|NCT00793624|147174968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.021||0.2579||95.0|-0.017|0.065|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.065|-0.017|0.2579
73812735|NCT00793624|147174969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.021||0.0011||95.0|0.027|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.109|0.027|0.0011
73812736|NCT00793624|147174969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.021||0.0069||95.0|0.018|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.101|0.018|0.0069
73812737|NCT00793624|147174969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.040|<0.0001
73812738|NCT00793624|147174970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.135|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.220|0.135|<0.0001
73812739|NCT00793624|147174970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.108|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.108|<0.0001
73812740|NCT00793624|147174970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.148|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.233|0.148|<0.0001
73812741|NCT00793624|147174971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.124|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.124|<0.0001
73812742|NCT00793624|147174971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.109|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.195|0.109|<0.0001
73812743|NCT00793624|147174971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.139|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.226|0.139|<0.0001
73812744|NCT00793624|147174972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.122|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.208|0.122|<0.0001
73812745|NCT00793624|147174972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.116|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.203|0.116|<0.0001
73812746|NCT00793624|147174972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.13|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.218|0.130|<0.0001
73812747|NCT00793624|147174973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.104|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.191|0.104|<0.0001
73812748|NCT00793624|147174973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.112|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.112|<0.0001
73812749|NCT00793624|147174973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.123|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.211|0.123|<0.0001
73812750|NCT00793624|147174974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.095|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.183|0.095|<0.0001
73812751|NCT00793624|147174974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.095|0.184|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.184|0.095|<0.0001
73812752|NCT00793624|147174974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.117|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.206|0.117|<0.0001
73812753|NCT00793624|147174975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.149|0.297|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.297|0.149|<0.0001
73812754|NCT00793624|147174975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.309|0.161|<0.0001
73812755|NCT00793624|147174975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.233|0.381|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.381|0.233|<0.0001
73812756|NCT00793624|147174976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.161|<0.0001
73896331|NCT02908490|147326107|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|74.93||||0.077|TWO_SIDED|95.0|-7.98|157.84||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||157.84|-7.98|0.077
73812757|NCT00793624|147174976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.175|0.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.324|0.175|<0.0001
73812758|NCT00793624|147174976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.235|0.384|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.384|0.235|<0.0001
73812759|NCT00793624|147174977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.135|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.285|0.135|<0.0001
73812760|NCT00793624|147174977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.179|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.329|0.179|<0.0001
73812761|NCT00793624|147174977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.201|0.352|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.352|0.201|<0.0001
73896332|NCT03467152|147326116|SUPERIORITY|||||||0.6909||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.6909
73812762|NCT00793624|147174978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.107|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.258|0.107|<0.0001
73812763|NCT00793624|147174978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.139|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.291|0.139|<0.0001
73896333|NCT03467152|147326117|SUPERIORITY||Odds Ratio (OR)|1.018||||0.8251|TWO_SIDED|95.0|0.695|1.492||Generalized Linear Mixed Models Analysis (GLMM)|GLMM|||||1.492|0.695|0.8251
73812764|NCT00793624|147174978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.166|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.318|0.166|<0.0001
73812765|NCT00793624|147174979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.103|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.256|0.103|<0.0001
73812766|NCT00793624|147174979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.126|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.280|0.126|<0.0001
73812767|NCT00793624|147174979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.166|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.320|0.166|<0.0001
73812768|NCT00793624|147174980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.039||0.0781||95.0|-0.008|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.143|-0.008|0.0781
73812769|NCT00793624|147174980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.039||0.0455||95.0|0.002|0.153|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.153|0.002|0.0455
73812770|NCT00793624|147174980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.039||0.029||95.0|0.009|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.160|0.009|0.0290
73812771|NCT00793624|147174981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.039||0.0043||95.0|0.035|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.186|0.035|0.0043
73812772|NCT00793624|147174981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.039||0.0007||95.0|0.055|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.207|0.055|0.0007
73812773|NCT00793624|147174981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.039||0.0005||95.0|0.06|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.212|0.060|0.0005
73812774|NCT00793624|147174982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.039||0.0136||95.0|0.02|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.173|0.020|0.0136
73812775|NCT00793624|147174982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.039||0.0076||95.0|0.028|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.182|0.028|0.0076
73812776|NCT00793624|147174982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.039||0.0294||95.0|0.009|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.163|0.009|0.0294
73812777|NCT00793624|147174983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.039||0.8674||95.0|-0.071|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.084|-0.071|0.8674
73812778|NCT00793624|147174983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.04||0.6487||95.0|-0.06|0.096|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.096|-0.060|0.6487
73812779|NCT00793624|147174983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.04||0.9267||95.0|-0.074|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.081|-0.074|0.9267
73812780|NCT00793624|147174984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.04||0.1603||95.0|-0.022|0.134|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.134|-0.022|0.1603
73812781|NCT00793624|147174984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.04||0.0399||95.0|0.004|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.160|0.004|0.0399
73812782|NCT00793624|147174984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.04||0.6328||95.0|-0.059|0.098|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.098|-0.059|0.6328
73812783|NCT00793624|147174985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.04||0.127||95.0|-0.017|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.139|-0.017|0.1270
73812784|NCT00793624|147174985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.04||0.1076||95.0|-0.014|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.014|0.1076
73812785|NCT00793624|147174985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.04||0.1492||95.0|-0.021|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.137|-0.021|0.1492
73812786|NCT00793624|147174986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.04||0.0385||95.0|0.004|0.162|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.162|0.004|0.0385
73812787|NCT00793624|147174986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.04||0.142||95.0|-0.02|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.138|-0.020|0.1420
73812788|NCT00793624|147174986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.04||0.0965||95.0|-0.012|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.147|-0.012|0.0965
73812789|NCT00793624|147174987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.04||0.1394||95.0|-0.019|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.138|-0.019|0.1394
73812790|NCT00793624|147174987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.04||0.1532||95.0|-0.022|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.137|-0.022|0.1532
73812791|NCT00793624|147174987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.041||0.5511||95.0|-0.055|0.104|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.104|-0.055|0.5511
73812792|NCT00793624|147174988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.108|0.264|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.264|0.108|<0.0001
73812793|NCT00793624|147174988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.128|0.284|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.284|0.128|<0.0001
73812794|NCT00793624|147174988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.205|0.361|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.361|0.205|<0.0001
73812795|NCT00793624|147174989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.131|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.288|0.131|<0.0001
73812796|NCT00793624|147174989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.310|0.153|<0.0001
73812797|NCT00793624|147174989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.187|0.344|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.344|0.187|<0.0001
73812798|NCT00793624|147174990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.108|0.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.267|0.108|<0.0001
73812799|NCT00793624|147174990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.159|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.159|<0.0001
73812800|NCT00793624|147174990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.177|0.336|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.336|0.177|<0.0001
73812801|NCT00793624|147174991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.092|0.253|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.253|0.092|<0.0001
73812802|NCT00793624|147174991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.127|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.288|0.127|<0.0001
73812803|NCT00793624|147174991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.137|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.298|0.137|<0.0001
73812804|NCT00793624|147174992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003||95.0|0.07|0.231|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.231|0.070|0.0003
73812805|NCT00793624|147174992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.096|0.259|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.259|0.096|<0.0001
73812806|NCT00793624|147174992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001||95.0|0.141|0.304|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.304|0.141|<0.0001
73812807|NCT00793624|147174993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.067|STANDARD_ERROR_OF_MEAN|4.639||0.0012|TWO_SIDED|95.0|5.962|24.173|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||24.173|5.962|0.0012
73812808|NCT00793624|147174993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.999|STANDARD_ERROR_OF_MEAN|4.611||0.0012||95.0|5.949|24.049|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||24.049|5.949|0.0012
73812809|NCT00793624|147174993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.642|STANDARD_ERROR_OF_MEAN|4.601||0.0001|TWO_SIDED|95.0|8.61|26.673|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||26.673|8.610|0.0001
73812810|NCT00793624|147174993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.721|STANDARD_ERROR_OF_MEAN|4.606||0.0001|TWO_SIDED|95.0|8.68|26.762|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||26.762|8.680|0.0001
73812811|NCT00793624|147174993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.471|STANDARD_ERROR_OF_MEAN|4.579|<|0.0001|TWO_SIDED|95.0|9.484|27.458|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||27.458|9.484|<0.0001
73812812|NCT00793624|147174993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.873|STANDARD_ERROR_OF_MEAN|4.548|<|0.0001|TWO_SIDED|95.0|8.947|26.799|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||26.799|8.947|<0.0001
73812813|NCT00793624|147174994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.403|STANDARD_ERROR_OF_MEAN|0.133||0.0026|TWO_SIDED|95.0|-0.665|-0.141|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.141|-0.665|0.0026
73812814|NCT00793624|147174994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.327|STANDARD_ERROR_OF_MEAN|0.133||0.0141|TWO_SIDED|95.0|-0.587|-0.066|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.066|-0.587|0.0141
73812815|NCT00793624|147174994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.132||0.2677|TWO_SIDED|95.0|-0.406|0.113|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||0.113|-0.406|0.2677
73812816|NCT00793624|147174994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.602|STANDARD_ERROR_OF_MEAN|0.171||0.0005|TWO_SIDED|95.0|-0.939|-0.266|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.266|-0.939|0.0005
73812817|NCT00793624|147174994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.914|-0.247|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.247|-0.914|0.0007
73812818|NCT00793624|147174994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.169||0.0391|TWO_SIDED|95.0|-0.683|-0.018|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.018|-0.683|0.0391
73812819|NCT00793624|147174994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.991|STANDARD_ERROR_OF_MEAN|0.269||0.0002|TWO_SIDED|95.0|-1.518|-0.464|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.464|-1.518|0.0002
73812820|NCT00793624|147174994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.902|STANDARD_ERROR_OF_MEAN|0.267||0.0008|TWO_SIDED|95.0|-1.426|-0.378|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.378|-1.426|0.0008
73896334|NCT03467152|147326118|SUPERIORITY||Odds Ratio (OR)|0.853||||0.3003|TWO_SIDED|95.0|0.584|1.247||Generalized Linear Mixed Models Analysis (GLMM)|GLMM|||||1.247|0.584|0.3003
73812821|NCT00793624|147174994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.473|STANDARD_ERROR_OF_MEAN|0.266||0.0758|TWO_SIDED|95.0|-0.994|0.049|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||0.049|-0.994|0.0758
73812822|NCT00793624|147174995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0003||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.2|-0.6|0.0003
73812823|NCT00793624|147174995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0073||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0073
73812824|NCT00793624|147174995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0017||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0017
73812825|NCT00793624|147174996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0021||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0021
73896335|NCT03467152|147326119|SUPERIORITY|||||||0.9198||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.9198
73812826|NCT00793624|147174996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.2|-0.6|<0.0001
73812827|NCT00793624|147174996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0121||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0121
73812828|NCT00793624|147174997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.032||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0320
73812829|NCT00793624|147174997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0447||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.0|-0.4|0.0447
73812830|NCT00793624|147174997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1332||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.0|-0.4|0.1332
73812831|NCT00793624|147174998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4105||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.1|-0.3|0.4105
73812832|NCT00793624|147174998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0584||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||0.0|-0.4|0.0584
73812833|NCT00793624|147174998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1006||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.0|-0.4|0.1006
73812834|NCT00793624|147174999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.571|STANDARD_ERROR_OF_MEAN|0.335||0.0882||95.0|-0.085|1.227|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.227|-0.085|0.0882
73812835|NCT00793624|147174999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.664|STANDARD_ERROR_OF_MEAN|0.336||0.0484||95.0|0.005|1.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.324|0.005|0.0484
73812836|NCT00793624|147174999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.758|STANDARD_ERROR_OF_MEAN|0.338||0.0252||95.0|0.094|1.421|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.421|0.094|0.0252
73812837|NCT00793624|147175000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.381|STANDARD_ERROR_OF_MEAN|0.34||0.2625||95.0|-0.285|1.047|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.047|-0.285|0.2625
73812838|NCT00793624|147175000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.543|STANDARD_ERROR_OF_MEAN|0.341||0.1109||95.0|-0.125|1.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.211|-0.125|0.1109
73812839|NCT00793624|147175000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.394|STANDARD_ERROR_OF_MEAN|0.343||0.2507||95.0|-0.278|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.066|-0.278|0.2507
73812840|NCT00793624|147175001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.342||0.4895||95.0|-0.439|0.902|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.902|-0.439|0.4895
73812841|NCT00793624|147175001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.434|STANDARD_ERROR_OF_MEAN|0.344||0.2073||95.0|-0.24|1.107|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.107|-0.240|0.2073
73812842|NCT00793624|147175001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.345||0.9462||95.0|-0.653|0.7|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.700|-0.653|0.9462
73812843|NCT00793624|147175002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.345||0.6309||95.0|-0.511|0.842|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.842|-0.511|0.6309
73812844|NCT00793624|147175002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.348||0.9227||95.0|-0.717|0.649|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.649|-0.717|0.9227
73812845|NCT00793624|147175002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.349||0.503||95.0|-0.451|0.919|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.919|-0.451|0.5030
73812846|NCT00793624|147175003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.112|STANDARD_ERROR_OF_MEAN|0.347||0.7459||95.0|-0.793|0.568|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.568|-0.793|0.7459
73896336|NCT03467152|147326120|SUPERIORITY|||||||0.2909|||||||ANCOVA|||||||0.2909
73812847|NCT00793624|147175003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.351||0.8534||95.0|-0.753|0.623|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.623|-0.753|0.8534
73812848|NCT00793624|147175003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.377|STANDARD_ERROR_OF_MEAN|0.352||0.5099||95.0|-1.068|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.314|-1.068|0.5099
73812849|NCT00793624|147175004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.348||0.785||95.0|-0.587|0.777|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.777|-0.587|0.7850
73812850|NCT00793624|147175004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.383|STANDARD_ERROR_OF_MEAN|0.352||0.2755||95.0|-0.306|1.073|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.073|-0.306|0.2755
73812851|NCT00793624|147175004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.353||0.7618||95.0|-0.584|0.798|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.798|-0.584|0.7618
73812852|NCT00793624|147175005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162|STANDARD_ERROR_OF_MEAN|0.19||0.3424||95.0|0.843|1.603|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.603|0.843|0.3424
73812853|NCT00793624|147175005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.186|STANDARD_ERROR_OF_MEAN|0.195||0.3023||95.0|0.859|1.636|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.636|0.859|0.3023
73812854|NCT00793624|147175005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854|STANDARD_ERROR_OF_MEAN|0.15||0.3589||95.0|0.605|1.205|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.205|0.605|0.3589
73812855|NCT00793624|147175006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.818|STANDARD_ERROR_OF_MEAN|0.841||0.191||95.0|0.734|4.503|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||4.503|0.734|0.1910
73812856|NCT00793624|147175006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.743|STANDARD_ERROR_OF_MEAN|0.817||0.2274||95.0|0.695|4.369|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||4.369|0.695|0.2274
73812857|NCT00793624|147175006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.346|STANDARD_ERROR_OF_MEAN|0.664||0.5538||95.0|0.512|3.538|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||3.538|0.512|0.5538
73812858|NCT00793624|147175007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.101|STANDARD_ERROR_OF_MEAN|0.195||0.5577||95.0|0.778|1.557|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.557|0.778|0.5577
73812859|NCT00793624|147175007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017|STANDARD_ERROR_OF_MEAN|0.184||0.9423||95.0|0.714|1.448|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.448|0.714|0.9423
73812860|NCT00793624|147175007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.735|STANDARD_ERROR_OF_MEAN|0.143||0.1097||95.0|0.502|1.076|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.076|0.502|0.1097
73812861|NCT00793624|147175008|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2521|STANDARD_ERROR_OF_MEAN|0.2064||0.1729||95.0|0.906|1.7304|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.7304|0.9060|0.1729
73812862|NCT00793624|147175008|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.222|STANDARD_ERROR_OF_MEAN|0.2039||0.2297||95.0|0.8808|1.6954|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.6954|0.8808|0.2297
73812863|NCT00793624|147175008|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8968|STANDARD_ERROR_OF_MEAN|0.1575||0.5354||95.0|0.6353|1.2659|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.2659|0.6353|0.5354
73812864|NCT00793624|147175009|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.8821|STANDARD_ERROR_OF_MEAN|1.0358||0.2508||95.0|0.6391|5.543|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||5.5430|0.6391|0.2508
73812865|NCT00793624|147175009|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.3877|STANDARD_ERROR_OF_MEAN|1.3119||0.1135||95.0|0.8122|7.0194|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||7.0194|0.8122|0.1135
73812866|NCT00793624|147175009|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0289|STANDARD_ERROR_OF_MEAN|0.6013||0.9611||95.0|0.3268|3.2395|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||3.2395|0.3268|0.9611
73812867|NCT00793624|147175010|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1621|STANDARD_ERROR_OF_MEAN|0.2075||0.4002||95.0|0.8187|1.6497|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.6497|0.8187|0.4002
73812868|NCT00793624|147175010|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0733|STANDARD_ERROR_OF_MEAN|0.1957||0.6983||95.0|0.7503|1.5352|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.5352|0.7503|0.6983
73896337|NCT03467152|147326121|SUPERIORITY|||||||0.6127||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.6127
73812869|NCT00793624|147175010|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.781|STANDARD_ERROR_OF_MEAN|0.1516||0.2033||95.0|0.5336|1.1433|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.1433|0.5336|0.2033
73812870|NCT00793624|147175013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.509|STANDARD_ERROR_OF_MEAN|0.23||0.027||95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo||0.960|0.058|0.0270
73812871|NCT00793624|147175013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.525|STANDARD_ERROR_OF_MEAN|0.226||0.0203||95.0|0.082|0.967||See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|pattern mixture model||"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo||0.967|0.082|0.0203
73812872|NCT00793624|147175013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.355|STANDARD_ERROR_OF_MEAN|0.226||0.1166||95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo||0.799|-0.088|0.1166
73896338|NCT03467152|147326122|SUPERIORITY|||||||0.878||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.8780
73896339|NCT03467152|147326123|SUPERIORITY|||||||0.409||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.4090
73896340|NCT03467152|147326124|SUPERIORITY|||||||0.8736||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.8736
73896341|NCT01236547|147326132|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.2831|TWO_SIDED|95.0|0.52|1.43||One-sided significance level = 0.1379|Log Rank||Reference arm = placebo|Assuming hazard ratio (pazopanib/placebo) of 0.625 (1-year 19% vs. 35.4%), 1-sided alpha 0.15, logrank test, 80% power, 1 interim analysis, required 71 deaths in 79 eligible patients (88 allowing 10% ineligible) in original design. The protocol was amended for phase II final analysis to be performed after all phase II eligible participants were potentially followed for 3 years with 1-sided alpha 0.1379, providing 77% power. See Limitations and Caveats||1.43|0.52|0.2831
73896342|NCT01236547|147326134|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.688|TWO_SIDED|95.0|0.55|2.67|||Log Rank|One-sided significance level = 0.15|Reference arm = placebo|||2.67|0.55|0.6880
73896343|NCT01236547|147326135|SUPERIORITY|||||||0.1921||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.1921
73896344|NCT01236547|147326136|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.00
73896345|NCT01236547|147326137|SUPERIORITY|||||||1|||||||Fisher Exact|Two-sided significance level = 0.05||||||1.00
73896346|NCT00412373|147326157|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.6||0.774||95.0|-2.7|3.7|||ANOVA|P-value based on the actual value and was from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.|Paliperidone Extended Release (ER) - Placebo on the Actual Score.|||3.7|-2.7|0.774
73896347|NCT00412373|147326158|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|2.3|<|0.001||95.0|-13.8|-4.9|||ANCOVA|P-values are from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-4.9|-13.8|<0.001
73896348|NCT00412373|147326159|SUPERIORITY_OR_OTHER||LS Means Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|-4.4|-1.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.2|-4.4|<0.001
73896349|NCT00412373|147326160|SUPERIORITY_OR_OTHER||LS Means Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.1|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.8|-3.1|<0.001
73896350|NCT00412373|147326161|SUPERIORITY_OR_OTHER||LS Means Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.8|-2.3|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-2.3|-6.8|<0.001
73896351|NCT00412373|147326162|SUPERIORITY_OR_OTHER||LS Means Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|-4.2|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.1|-4.2|<0.001
73896352|NCT00412373|147326163|SUPERIORITY_OR_OTHER||LS Means Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.3|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.9|-3.3|<0.001
73896353|NCT00412373|147326164|SUPERIORITY_OR_OTHER||LS Means Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.5|<|0.001||95.0|-2.9|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.9|-2.9|<0.001
73896354|NCT00412373|147326165|SUPERIORITY_OR_OTHER||LS Means Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5||0.001||95.0|-2.6|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.6|-2.6|0.001
73896355|NCT00412373|147326166|SUPERIORITY_OR_OTHER||LS Means Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.016||95.0|-1.8|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.2|-1.8|0.016
73812873|NCT02921750|147175014|NON_INFERIORITY|In this non-inferiority study the primary efficacy analysis included constructing a two sided 95% confidence interval, using Fisher's non-parametric permutation test, for between-treatment differences (Exufiber - Aquacel Extra) in the mean percentage area change from baseline to 6 weeks. This means that if the lower limit of this confidence interval was found to be greater than 12%, non-inferiority will be established.|Mean Difference (Final Values)|-29.4||||0.093|TWO_SIDED|95.0|-63.5|3.2|||Fisher Exact|||||3.2|-63.5|0.093
73812874|NCT03309696|147175022|EQUIVALENCE|A p value of \<.0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.59||||0.055|TWO_SIDED|||||The p value is not adjusted because it was a planned contrast.|Mixed Models Analysis||Active tDCS - sham tDCS.|Examines the effect of tDCS preconditioning on P100 amplitudes. The effect size for this comparison was .33 (Cohen's).||||.055
73812875|NCT03309696|147175022|EQUIVALENCE|A p value of \<.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|0.36||||0.0418|TWO_SIDED|||||This p value is not adjusted for multiple comparisons because it was a planned contrast.|Mixed Models Analysis||Sham tDCS - Sham tDCS and Active rTMS|Examines the effect of rTMS on the P100 amplitude. The calculated effect size is .35 (Cohen's).||||0.0418
73812876|NCT03309696|147175022|EQUIVALENCE|A p value less than 0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.19||||0.4|TWO_SIDED|||||The p value is not adjusted as this was a planned contrast.|Mixed Models Analysis||Effect of tDCS preconditioning on active rTMS: active tDCS preconditioning of active rTMS - sham tDCS preconditioning of active rTMS.|Examines the additive effect of tDCS preconditioning on the P100 amplitude after rTMS. The effect size for this comparison was 0.14.||||0.40
73812877|NCT03309696|147175022|EQUIVALENCE|A p value less than 0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.48||||0.086|TWO_SIDED|||||The p value was not adjusted for this planned contrast.|Mixed Models Analysis||Active tDCS and Active rTMS - Sham tDCS and Sham rTMS.|Examines the combined effect of tDCS and rTMS on the P100 amplitude. The effect size for this comparison was .29 (Cohen's).||||.086
73812878|NCT00328094|147175028|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29||||0.23|TWO_SIDED|95.0|0.85|1.97|||Chi-squared|||||1.97|0.85|0.23
73812879|NCT02368210|147175030|SUPERIORITY||||||<|0.001||||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||||||<0.001
73812880|NCT02368210|147175031|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Scaling.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
73812881|NCT02368210|147175031|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: erythema.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
73896356|NCT00412373|147326168|SUPERIORITY_OR_OTHER||LS Means Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1||0.002||95.0|-0.7|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.2|-0.7|0.002
73812882|NCT02368210|147175031|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Plaque Elevation.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
73812883|NCT00078949|147175036|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The literature has suggested that the ORR is approximately 50% for this patient population treated with DHAP. The treatment difference is defined as the response rate for the DHAP arm minus that of GDP arm. We would consider GDP to be non-inferior to DHAP if we are 95% sure that the true difference is less than 10%. In order to rule out that the 10% difference with 80% power, we need to accrue a total of 630 eligible patients. The actual sample size for this final analysis is 619 patients.|Risk Difference (RD)|-1.2||||0.005|TWO_SIDED|95.0|-9.0|6.7||p-value for non-inferiority|Cochran-Mantel-Haenszel|||||6.7|-9.0|0.005
73812884|NCT00078949|147175037|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.1||||0.55||95.0|-10.0|5.8|||Cochran-Mantel-Haenszel|||||5.8|-10.0|0.55
73812885|NCT00078949|147175038|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.17|TWO_SIDED|95.0|0.52|1.12|||Log Rank|||It was estimated that 240 patients will be eligible for the maintenance question, and randomized with a 1:1 ratio to either rituximab or observation. It is expected that the 2-year event-free survival will be 50% on the observation arm. In order to detect a 15% difference in the 2-year event-free survival with an 80% power using a two-sided 5% level test, 142 events are required to detect an HR of 0.622.||1.12|0.52|0.17
73812886|NCT00956631|147175077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|||<|0.0001|TWO_SIDED|95.0|2.29|4.13|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used throughout. A hypothetical average improvement of zero was used.||4.13|2.29|<0.0001
73812887|NCT00956631|147175078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.58|||<|0.0001|TWO_SIDED|95.0|12.33|22.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used. A hypothetical average improvement of zero was used.||22.83|12.33|<0.0001
73812888|NCT00033657|147175081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|TWO_SIDED|95.0|||||Log Rank|||||||0.48
73896357|NCT00412373|147326169|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-0.9|-0.3|||ANOVA|P-value is from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.||||-0.3|-0.9|<0.001
73812889|NCT02945254|147175107|SUPERIORITY|||||||0.011||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.011
73812890|NCT02945254|147175108|SUPERIORITY|||||||0.13||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.13
73896358|NCT00412373|147326170|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.046
73812891|NCT03422159|147175109|NON_INFERIORITY|Based on the results of the preliminary study of Marik et al, 5 we projected that the combination of ascorbic acid, thiamine, and hydrocortisone could reduce time to vasopressor discontinuation from 54 (+/-30 hours) vs 30 hours. For the additional primary outcome, we projected a greater change of SOFA score of 4 (+/-3) vs 2. Assuming a type 1 error of 5% (alpha of 0.05) and a power of 80%, this study would require a sample size of 94 patients.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73812892|NCT02631070|147175118|SUPERIORITY||Common Risk Difference on Response Rate|24.56|||<|0.0001|TWO_SIDED|95.0|14.48|34.64|||Cochran-Mantel-Haenszel|||||34.64|14.48|<0.0001
73812893|NCT02631070|147175118|SUPERIORITY||Odds Ratio (OR)|5.065|||<|0.0001|TWO_SIDED|95.0|2.278|11.259|||Cochran-Mantel-Haenszel|||||11.259|2.278|<0.0001
73812894|NCT02631070|147175119|SUPERIORITY||Common Risk Difference on Response Rate|20.0||||0.0002|TWO_SIDED|95.0|10.92|29.08|||Cochran-Mantel-Haenszel|||||29.08|10.92|0.0002
73812895|NCT02631070|147175119|SUPERIORITY||Odds Ratio (OR)|5.071||||0.0002|TWO_SIDED|95.0|2.002|12.844|||Cochran-Mantel-Haenszel|||||12.844|2.002|0.0002
73812896|NCT02631070|147175120|SUPERIORITY||Common Risk Difference on Response Rate|21.37||||0.0003|TWO_SIDED|95.0|11.23|31.51|||Cochran-Mantel-Haenszel|||||31.51|11.23|0.0003
73812897|NCT02631070|147175120|SUPERIORITY||Odds Ratio (OR)|4.045||||0.0003|TWO_SIDED|95.0|1.827|8.956|||Cochran-Mantel-Haenszel|||||8.956|1.827|0.0003
73812898|NCT02631070|147175121|SUPERIORITY||Common Risk Difference on Response Rate|29.55|||<|0.0001|TWO_SIDED|95.0|18.73|40.36|||Cochran-Mantel-Haenszel|||||40.36|18.73|<0.0001
73812899|NCT02631070|147175121|SUPERIORITY||Odds Ratio (OR)|5.306|||<|0.0001|TWO_SIDED|95.0|2.526|11.146|||Cochran-Mantel-Haenszel|||||11.146|2.526|<0.0001
73812900|NCT02631070|147175123|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||<0.0001
73812901|NCT02631070|147175123|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||<0.0001
73812902|NCT02631070|147175124|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 24||||<0.0001
73812903|NCT02631070|147175124|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 48||||<0.0001
73812904|NCT02631070|147175125|SUPERIORITY||Hazard Ratio (HR)|0.446||||0.0445|TWO_SIDED|95.0|0.196|1.013|||Log Rank||HR is from the Cox proportional hazards model|||1.013|0.196|0.0445
73812905|NCT02631070|147175126|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.5121|TWO_SIDED|95.0|0.362|1.699|||Log Rank||HR is from the Cox proportional hazards model|||1.699|0.362|0.5121
73812906|NCT02631070|147175128|SUPERIORITY|||||||0.2382|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||0.2382
73812907|NCT02631070|147175128|SUPERIORITY|||||||0.5127|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||0.5127
73812908|NCT02631070|147175129|SUPERIORITY|||||||0.5479|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||0.5479
73812909|NCT02631070|147175129|SUPERIORITY|||||||0.298|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||0.2980
73812910|NCT02631070|147175130|SUPERIORITY||LS Mean Difference|-229.1|STANDARD_ERROR_OF_MEAN|74.43||0.0024|TWO_SIDED|95.0|-375.8|-82.4|||ANCOVA|||Week 9 Through 24||-82.4|-375.8|0.0024
73812911|NCT02631070|147175130|SUPERIORITY||LS Mean Difference|-319.5|STANDARD_ERROR_OF_MEAN|144.57||0.0294|TWO_SIDED|95.0|-606.3|-32.7|||ANCOVA|||Week 33 Through 48||-32.7|-606.3|0.0294
73812912|NCT02631070|147175131|SUPERIORITY||LS Mean Difference|-41.0|STANDARD_ERROR_OF_MEAN|40.18||0.3087|TWO_SIDED|95.0|-120.3|38.2|||ANCOVA|||Weeks 9 Through 24||38.2|-120.3|0.3087
73812913|NCT02631070|147175131|SUPERIORITY||LS Mean Difference|-24.9|STANDARD_ERROR_OF_MEAN|93.42||0.7903|TWO_SIDED|95.0|-210.7|160.8|||ANCOVA|||Weeks 33 Through 48||160.8|-210.7|0.7903
73812914|NCT02631070|147175136|SUPERIORITY||Hazard Ratio (HR)|0.986||||0.958|TWO_SIDED|95.0|0.595|1.636|||Log Rank||HR is from the Cox proportional hazards model|||1.636|0.595|0.9580
73812915|NCT01153620|147175168|SUPERIORITY_OR_OTHER||||||=|0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.006
73812916|NCT01832818|147175183|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
73812917|NCT01832818|147175184|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< 0.05
73812918|NCT01256385|147175220|SUPERIORITY_OR_OTHER|||||||0.73|||||||Log Rank|||||||0.73
73812919|NCT01256385|147175221|SUPERIORITY_OR_OTHER|||||||0.87|||||||Log Rank|||||||0.87
73812920|NCT01256385|147175222|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||||||0.20
73812921|NCT01256385|147175223|SUPERIORITY|||||||0.006|||||||Chi-squared|||PFS at 4 months in Arm A was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).||||0.006
73812922|NCT01256385|147175223|SUPERIORITY|||||||0.037||||||1-sided.|Chi-squared|||PFS at 4 months in Arm B was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).||||0.037
73812923|NCT01256385|147175224|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
73812924|NCT01225289|147175228|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
73812925|NCT01606202|147175250|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.708|TWO_SIDED|95.0|-0.51|0.35|||ANCOVA|||The change in the pain Numerical Rating Scale score from baseline to End of Treatment was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale pain mean score as a covariate.||0.35|-0.51|0.708
73812926|NCT01606202|147175251|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.57||||0.852|TWO_SIDED|95.0|-6.62|5.48|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which escape medication was used was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and percentage of days on which escape medication was used as a covariate.||5.48|-6.62|0.852
73812927|NCT01606202|147175252|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.05||||0.86|TWO_SIDED|95.0|-0.54|0.65|||ANCOVA|||The change from baseline to End of Treatment in the Spasm severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm severity Numerical Rating Scale score as a covariate.||0.65|-0.54|0.860
73812928|NCT01606202|147175253|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.873|TWO_SIDED|95.0|-8.56|7.27|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasm was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm percentage of days on which spasm was experienced as a covariate.||7.27|-8.56|0.873
73812929|NCT01606202|147175254|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.07||||0.83|TWO_SIDED|95.0|-0.61|0.75|||ANCOVA|||The change from baseline to End of Treatment in the spasticity severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline spasticity severity Numerical Rating Scale score as a covariate.||0.75|-0.61|0.830
73812930|NCT01606202|147175255|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.4||||0.86|TWO_SIDED|95.0|-4.08|4.88|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasticity was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the percentage of days on which spasticity was experienced as a covariate.||4.88|-4.08|0.860
73812931|NCT01606202|147175256|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.14||||0.142|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|||The change from baseline to End of Treatment in the Modified Ashworth scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Modified Ashworth scale score as a covariate.||0.05|-0.33|0.142
73812932|NCT01606202|147175257|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.824|TWO_SIDED|95.0|-1.13|0.9|||ANCOVA|||The change from baseline in the mean Short Orientation Memory Concentration score, was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Short Orientation Memory Concentration test score as a covariate.||0.90|-1.13|0.824
73812933|NCT01606202|147175258|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.04||||0.847|TWO_SIDED|95.0|-0.49|0.4|||ANCOVA|||The change from baseline to End of Treatment in the Spitzer Quality of Life Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spitzer Quality of Life Index score as a covariate.||0.40|-0.49|0.847
73812934|NCT01606202|147175259|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.29||||0.287|TWO_SIDED|95.0|-3.74|1.16|||ANCOVA|||The change from baseline to End of Treatment in the Caregiver Strain Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline Caregiver Strain Index score as a covariate.||1.16|-3.74|0.287
73812935|NCT01606202|147175260|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|33.86|||<|0.001|TWO_SIDED|95.0|17.07|50.64|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups using Fisher's Exact Test.||50.64|17.07|<0.001
73812936|NCT01606202|147175261|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.93||||0.032|TWO_SIDED|95.0|-3.69|-0.16|||ANCOVA|||The change from baseline to End of Treatment in the Brief Pain Inventory score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Brief Pain Inventory score as a covariate.||-0.16|-3.69|0.032
73812937|NCT02584959|147175264|OTHER||Difference in LS means|-2.32|||<|0.0001|TWO_SIDED|95.0|-2.895|-1.744|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-1.744|-2.895|<0.0001
73812938|NCT02584959|147175266|OTHER||Difference in LS means|-2.323|||<|0.0001|TWO_SIDED|95.0|-2.969|-1.677|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-1.677|-2.969|<0.0001
73812939|NCT02584959|147175269|OTHER||Difference in LS means|-4.881|||<|0.0001|TWO_SIDED|95.0|-6.113|-3.649|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-3.649|-6.113|<0.0001
73812940|NCT02584959|147175270|OTHER||Difference in LS means|5.435|||<|0.0001|TWO_SIDED|95.0|3.981|6.889|||Mixed Models Analysis|||||6.889|3.981|<0.0001
73812941|NCT02584959|147175271|OTHER||Difference in LS means|-2.175|||<|0.0001|TWO_SIDED|95.0|-2.75|-1.599|||Mixed Models Analysis|||||-1.599|-2.750|<0.0001
73812942|NCT02584959|147175286|OTHER||Difference in LS means|-31.735||||0.0001|TWO_SIDED|95.0|-42.696|-20.773|||Mixed Models Analysis|||The Least Square means, 95% confidence intervals and p-values are based on mixed effect linear model with period, sequence, use of prophylactic therapy with C1 INH at randomization and treatment as fixed effects and subject nested within sequence as a random effect.||-20.773|-42.696|0.0001
73812943|NCT00195494|147175306|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.0|||<|0.001|||||||Fisher Exact||E+M (49.8%) - M (27.8%) creates the risk difference estimated value.|||||<0.001
73812944|NCT00195494|147175307|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0|||<|0.001|||||||Fisher Exact||E+M (79.7%) - M (58.7%) creates the risk difference estimated value.|||||<0.001
73812945|NCT03019003|147175311|OTHER||||||<|0.036|||||||t-test, 2 sided|||||||<0.036
73812946|NCT02502266|147175405|SUPERIORITY||Hazard Ratio (HR)|0.649|||||TWO_SIDED|95.0|0.424|0.995|||||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||0.995|0.424|
73812947|NCT02502266|147175405|SUPERIORITY||Hazard Ratio (HR)|0.832|||||TWO_SIDED|95.0|0.539|1.284|||||The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||1.284|0.539|
73812948|NCT02502266|147175405|SUPERIORITY||Hazard Ratio (HR)|1.149|||||TWO_SIDED|95.0|0.745|1.773|||||The hazard ratio estimate compares Olaparib to chemotherapy. If Olaparib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||1.773|0.745|
73812949|NCT02502266|147175406|SUPERIORITY||Hazard Ratio (HR)|0.796||||0.145|TWO_SIDED|98.0|0.597|1.06||The log rank test was stratified by the factors provided at randomization|Log Rank||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.060|0.597|0.145
73812950|NCT02502266|147175406|SUPERIORITY||Hazard Ratio (HR)|0.972||||1|TWO_SIDED|98.0|0.726|1.0|||Log Rank|The log rank test was stratified by the factors provided at randomization.|The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.00|0.726|1.0
73812951|NCT02502266|147175407|SUPERIORITY||Hazard Ratio (HR)|1.027|||||TWO_SIDED|98.0|0.771|1.368||No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.368|0.771|
73812952|NCT02502266|147175407|OTHER|No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|98.0|0.795|1.413||No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|||The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.413|0.795|
73812953|NCT00577005|147175424|SUPERIORITY_OR_OTHER||Slope|-0.05425|STANDARD_ERROR_OF_MEAN|0.03211||0.09|TWO_SIDED|||||p-value \<0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly cocaine urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z=-1.68950 p = 0.09112|||||0.09
73812954|NCT00577005|147175425|SUPERIORITY_OR_OTHER||Slope|0.0257|STANDARD_ERROR_OF_MEAN|0.04369||0.55|TWO_SIDED|||||p-value \<0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly opioid urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z= 0.58823 p = 0.55638|||||0.55
73812955|NCT00577005|147175426|SUPERIORITY_OR_OTHER|||||||0.67||||||p-value \<0.05 considered statistically significant|Log Rank|Chi-Square 0.175. df = 1, p=0.676||||||0.67
73812956|NCT00577005|147175427|SUPERIORITY_OR_OTHER||Slope|-0.1557||||0.11|TWO_SIDED|||||Significant p-value \< 0.05|Mixed Models Analysis||Interaction of time x group: Z = -1.5671, p = 0.11708|||||0.11
73812957|NCT01004432|147175428|SUPERIORITY_OR_OTHER||Percentage achive ACR 20 response|34.9|||<|0.0001|TWO_SIDED|95.0|30.4|39.4||One sided test adjusting for conducting one interim analysis|Chi-squared|||null hypothesis: proportion \<=0.2||39.4|30.4|<0.0001
73812958|NCT02539134|147175454|SUPERIORITY_OR_OTHER||Slope|1.06||||0.757|TWO_SIDED|90.0|0.741|1.374|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90 percent (%) confidence interval (CI) for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.374|0.741|0.757
73812959|NCT02539134|147175454|SUPERIORITY_OR_OTHER||Slope|1.37||||0.042|TWO_SIDED|90.0|1.078|1.664|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.664|1.078|0.042
73812960|NCT02539134|147175455|SUPERIORITY_OR_OTHER||Slope|1.2||||0.191|TWO_SIDED|90.0|0.946|1.45|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.450|0.946|0.191
73812961|NCT02539134|147175455|SUPERIORITY_OR_OTHER||Slope|1.37||||0.036|TWO_SIDED|90.0|1.089|1.657|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.657|1.089|0.036
73812962|NCT02539134|147175456|SUPERIORITY_OR_OTHER||Slope|1.19||||0.288|TWO_SIDED|90.0|0.89|1.489|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.489|0.890|0.288
73812963|NCT02539134|147175457|SUPERIORITY_OR_OTHER||Slope|1.36||||0.039|TWO_SIDED|90.0|1.08|1.642|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.642|1.080|0.039
73812964|NCT00985426|147175458|NON_INFERIORITY|Non-inferiority is achieved if the lower limit of the two-sided 95% CI was greater than -10%.|SPR Difference (%)|8.0|||||TWO_SIDED|95.0|1.7|14.3|||||SPR difference = SPR for HEPLISAV-B minus SPR for Engerix-B.|Two-sided 95% confidence intervals (CIs) of the difference in seroprotection rates (SPR) between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||14.3|1.7|
73812965|NCT00985426|147175458|SUPERIORITY|Superiority is achieved if the lower limit of the two-sided 95% CI was greater than 0%.|SPR Difference (%)|8.0|||||TWO_SIDED|95.0|1.7|14.3||||||Two-sided 95% CIs of the difference in SPR between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||14.3|1.7|
73812966|NCT00985426|147175463|SUPERIORITY|Superiority is achieved if the lower limit of the two-sided 95% CI was greater than 0%.|SPR Difference (%)|12.9|||||TWO_SIDED|95.0|4.4|21.2||||||Two-sided 95% CIs of the difference in SPRs between the HEPLISAV group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||21.2|4.4|
73812967|NCT01149421|147175467|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.79|||<|0.001|TWO_SIDED|97.3|-4.58|-1.0||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||-1.00|-4.58|<0.001
73812968|NCT01149421|147175467|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.07|||<|0.001|TWO_SIDED|97.3|-2.83|0.68||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||0.68|-2.83|<0.001
73812969|NCT01149421|147175467|SUPERIORITY_OR_OTHER||||||<|0.001||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||<0.001
73812970|NCT01149421|147175467|SUPERIORITY_OR_OTHER|||||||0.149||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.149
73812971|NCT01149421|147175468|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.66|||<|0.001|TWO_SIDED|97.3|-4.53|-0.79||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||-0.79|-4.53|<0.001
73812972|NCT01149421|147175468|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.71|||<|0.001|TWO_SIDED|97.3|-3.54|0.12||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||0.12|-3.54|<0.001
73812973|NCT01149421|147175468|SUPERIORITY_OR_OTHER|||||||0.002||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.002
73812974|NCT01149421|147175468|SUPERIORITY_OR_OTHER|||||||0.36||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.36
73812975|NCT01149421|147175469|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.32|||<|0.001|TWO_SIDED|97.3|-0.8|1.43||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.43|-0.80|<0.001
73812976|NCT01149421|147175469|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.42|||<|0.001|TWO_SIDED|97.3|-0.67|1.52||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.52|-0.67|<0.001
73812977|NCT01149421|147175469|SUPERIORITY_OR_OTHER|||||||0.87||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.870
73812978|NCT01149421|147175469|SUPERIORITY_OR_OTHER|||||||0.915||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.915
73812979|NCT01149421|147175469|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.5|||<|0.001|TWO_SIDED|97.3|-0.68|1.68||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.68|-0.68|<0.001
73812980|NCT01149421|147175469|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.16|||<|0.001|TWO_SIDED|97.3|-1.0|1.31||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.31|-1.00|<0.001
73812981|NCT01149421|147175469|SUPERIORITY_OR_OTHER|||||||0.929||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.929
73812982|NCT01149421|147175469|SUPERIORITY_OR_OTHER|||||||0.776||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.776
73812983|NCT01149421|147175470|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|2.84||||0.556|TWO_SIDED|97.3|1.52|4.16||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||4.16|1.52|0.556
73812984|NCT01149421|147175470|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.62||||0.018|TWO_SIDED|97.3|0.32|2.92||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||2.92|0.32|0.018
73812985|NCT01149421|147175470|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||1.00
73812986|NCT01149421|147175470|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|3.5||||0.904|TWO_SIDED|97.3|2.1|4.91||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||4.91|2.10|0.904
73812987|NCT01149421|147175470|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.26||||0.005|TWO_SIDED|97.3|-0.13|2.64||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||2.64|-0.13|0.005
73812988|NCT01149421|147175470|SUPERIORITY_OR_OTHER|||||||0.996||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.996
73812989|NCT01149421|147175471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|||<|0.001|TWO_SIDED|95.0|-4.0|-2.09||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||-2.09|-4.00|<0.001
73812990|NCT01149421|147175471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58||||0.001|TWO_SIDED|95.0|-2.51|-0.64||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||-0.64|-2.51|0.001
73812991|NCT01149421|147175471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.1|-2.09||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-2.09|-4.10|<0.001
73812992|NCT01149421|147175471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|||<|0.001|TWO_SIDED|95.0|-2.98|-1.0||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-1.00|-2.98|<0.001
73812993|NCT01149421|147175472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.218|TWO_SIDED|95.0|-1.84|0.42||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||0.42|-1.84|0.218
73812994|NCT01149421|147175472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.931|TWO_SIDED|95.0|-1.16|1.06||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||1.06|-1.16|0.931
73812995|NCT01149421|147175472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.315|TWO_SIDED|95.0|-1.72|0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||0.55|-1.72|0.315
73812996|NCT01149421|147175472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.465|TWO_SIDED|95.0|-1.54|0.7||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||0.70|-1.54|0.465
73812997|NCT01149421|147175473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||<|0.001|TWO_SIDED|95.0|-5.04|-1.61||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||-1.61|-5.04|<0.001
73812998|NCT01149421|147175473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.153|TWO_SIDED|95.0|-2.91|0.46||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||0.46|-2.91|0.153
73812999|NCT01149421|147175473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87||||0.002|TWO_SIDED|95.0|-4.66|-1.09||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-1.09|-4.66|0.002
73813000|NCT01149421|147175473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.042|TWO_SIDED|95.0|-3.57|-0.07||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-0.07|-3.57|0.042
73813001|NCT01149421|147175473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.221|TWO_SIDED|95.0|-3.23|0.75||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||0.75|-3.23|0.221
73813002|NCT01149421|147175473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.884|TWO_SIDED|95.0|-2.1|1.81||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||1.81|-2.10|0.884
73813003|NCT01149421|147175473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.19|TWO_SIDED|95.0|-4.31|-0.39||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-0.39|-4.31|0.19
73813004|NCT01149421|147175473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.159|TWO_SIDED|95.0|-3.31|0.54||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||0.54|-3.31|0.159
73813005|NCT01149421|147175473|SUPERIORITY_OR_OTHER|||||||0.122||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||||0.122
73813006|NCT01149421|147175473|SUPERIORITY_OR_OTHER|||||||0.601||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||||0.601
73813007|NCT01149421|147175473|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||||0.012
73813008|NCT01149421|147175473|SUPERIORITY_OR_OTHER|||||||0.274||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||||0.274
73813009|NCT01149421|147175474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.717|TWO_SIDED|95.0|-0.91|1.32||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||1.32|-0.91|0.717
73813010|NCT01149421|147175474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.427|TWO_SIDED|95.0|-0.65|1.54||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||1.54|-0.65|0.427
73813011|NCT01149421|147175474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.3|TWO_SIDED|95.0|-0.53|1.73||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.73|-0.53|0.300
73813012|NCT01149421|147175474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.788|TWO_SIDED|95.0|-0.96|1.26||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.26|-0.96|0.788
73813013|NCT01149421|147175474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08||||0.098|TWO_SIDED|95.0|-0.2|2.37||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||2.37|-0.20|0.098
73813014|NCT01149421|147175474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.203|TWO_SIDED|95.0|-0.44|2.08||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||2.08|-0.44|0.203
73813015|NCT01149421|147175474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.493|TWO_SIDED|95.0|-0.88|1.82||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.82|-0.88|0.493
73813016|NCT01149421|147175474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.692|TWO_SIDED|95.0|-1.06|1.6||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.60|-1.06|0.692
73813017|NCT01149421|147175474|SUPERIORITY_OR_OTHER|||||||0.99||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||||0.990
73813018|NCT01149421|147175474|SUPERIORITY_OR_OTHER|||||||0.173||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||||0.173
73813019|NCT01149421|147175474|SUPERIORITY_OR_OTHER|||||||0.972||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||||0.972
73813020|NCT01149421|147175474|SUPERIORITY_OR_OTHER|||||||0.904||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||||0.904
73813021|NCT01149421|147175475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||<|0.001|TWO_SIDED|95.0|1.17|3.8||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||3.80|1.17|<0.001
73813022|NCT01149421|147175475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.08|TWO_SIDED|95.0|-0.14|2.45||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||2.45|-0.14|0.080
73813023|NCT01149421|147175475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.23|4.91||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||4.91|2.23|<0.001
73813024|NCT01149421|147175475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92||||0.168|TWO_SIDED|95.0|-0.39|2.24||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||2.24|-0.39|0.168
73813025|NCT01149421|147175475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|||<|0.001|TWO_SIDED|95.0|2.62|5.28||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||5.28|2.62|<0.001
73813026|NCT01149421|147175475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.78|||<|0.001|TWO_SIDED|95.0|1.47|4.09||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||4.09|1.47|<0.001
73813027|NCT01149421|147175475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|||<|0.001|TWO_SIDED|95.0|2.49|5.47||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||5.47|2.49|<0.001
73813028|NCT01149421|147175475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.003|TWO_SIDED|95.0|0.78|3.7||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||3.70|0.78|0.003
73813029|NCT01149421|147175475|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||||<0.001
73813030|NCT01149421|147175475|SUPERIORITY_OR_OTHER|||||||0.014||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||||0.014
73813031|NCT01149421|147175475|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||||<0.001
73813032|NCT01149421|147175475|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||||0.005
73813033|NCT01149421|147175476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|||<|0.001|TWO_SIDED|95.0|-4.5|-2.43||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-2.43|-4.50|<0.001
73813034|NCT01149421|147175476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|||<|0.001|TWO_SIDED|95.0|-2.79|-0.75||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-0.75|-2.79|<0.001
73813035|NCT01149421|147175476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|||<|0.001|TWO_SIDED|95.0|-4.52|-2.28||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-2.28|-4.52|<0.001
73813036|NCT01149421|147175476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13|||<|0.001|TWO_SIDED|95.0|-3.23|-1.03||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-1.03|-3.23|<0.001
73813037|NCT01149421|147175476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|||<|0.001|TWO_SIDED|95.0|-3.43|-1.07||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-1.07|-3.43|<0.001
73813038|NCT01149421|147175476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.113|TWO_SIDED|95.0|-2.09|0.22||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||0.22|-2.09|0.113
73813039|NCT01149421|147175476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74|||<|0.001|TWO_SIDED|95.0|-3.86|-1.62||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-1.62|-3.86|<0.001
73813040|NCT01149421|147175476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.004|TWO_SIDED|95.0|-2.72|-0.51||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-0.51|-2.72|0.004
73813041|NCT01149421|147175477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.128|TWO_SIDED|95.0|-2.22|0.28||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||0.28|-2.22|0.128
73813042|NCT01149421|147175477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.883|TWO_SIDED|95.0|-1.32|1.13||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.13|-1.32|0.883
73813043|NCT01149421|147175477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.39|TWO_SIDED|95.0|-1.84|0.72||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||0.72|-1.84|0.390
73813044|NCT01149421|147175477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.463|TWO_SIDED|95.0|-1.72|0.79||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||0.79|-1.72|0.463
73813045|NCT01149421|147175477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.671|TWO_SIDED|95.0|-1.13|1.76||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.76|-1.13|0.671
73813046|NCT01149421|147175477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.471|TWO_SIDED|95.0|-0.9|1.95||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.95|-0.90|0.471
73813047|NCT01149421|147175477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.543|TWO_SIDED|95.0|-1.95|1.03||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||1.03|-1.95|0.543
73813048|NCT01149421|147175477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.728|TWO_SIDED|95.0|-1.72|1.2||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||1.20|-1.72|0.728
73813049|NCT01149421|147175490|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||||<0.001
73813050|NCT01149421|147175490|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||||0.005
73813051|NCT01149421|147175490|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||<0.001
73813052|NCT01149421|147175490|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.012
73813053|NCT00355706|147175496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.964||95.0|||||ANOVA|||||||0.964
73813054|NCT00355706|147175497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.892||95.0|||||ANOVA|||||||0.892
73813055|NCT00355706|147175498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56||95.0|||||ANOVA|||||||0.560
73813056|NCT00766467|147175516|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3
73813057|NCT00676572|147175520|SUPERIORITY||||||<|0.05||||||calculated p values|t-test, 2 sided|||||||<0.05
73813058|NCT01313494|147175522|SUPERIORITY_OR_OTHER||LSM Difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.095|||Repeated measures ANCOVA|Independent variables: treatment, baseline value of pre-bronchodilator FEV1, time and a treatment-by-time interaction.||The primary endpoint was tested in a confirmatory manner with a 2-sided significance level of 5%.||0.095|0.046|<0.0001
73813059|NCT00337779|147175564|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0732|STANDARD_ERROR_OF_MEAN|0.1013||0.4859|TWO_SIDED|95.0|0.8799|1.309|||Regression, Poisson||980 subjects randomized into two arms provide approximately 90% power to detect significant difference between groups of 30% or more in rate of confirmed relapses.|||1.3090|0.8799|0.4859
73813060|NCT01162122|147175576|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.12|||||TWO_SIDED|95.0|1.0|1.24||||||||1.24|1|
73813061|NCT01162122|147175576|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.05|||||TWO_SIDED|95.0|0.95|1.17||||||||1.17|0.95|
73813062|NCT01162122|147175576|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|0.94|||||TWO_SIDED|95.0|0.85|1.05||||||||1.05|0.85|
73813063|NCT01162122|147175576|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|1.01|||||TWO_SIDED|95.0|0.92|1.11||||||||1.11|0.92|
73813064|NCT01162122|147175576|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.99|||||TWO_SIDED|95.0|0.9|1.08||||||||1.08|0.9|
73813065|NCT01162122|147175576|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.98|||||TWO_SIDED|95.0|0.89|1.07||||||||1.07|0.89|
73813066|NCT01162122|147175576|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|1.0|||||TWO_SIDED|95.0|0.91|1.1||||||||1.1|0.91|
73813067|NCT01162122|147175576|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||TWO_SIDED|95.0|0.87|1.05||||||||1.05|0.87|
73813068|NCT01162122|147175576|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||TWO_SIDED|95.0|0.87|1.05||||||||1.05|0.87|
73813069|NCT01162122|147175577|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|1.32|1.49||||||||1.49|1.32|
73813070|NCT01162122|147175577|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H3N2 strain)|1.61|||||TWO_SIDED|95.0|1.52|1.7||||||||1.7|1.52|
73813071|NCT01162122|147175577|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (B strain)|1.15|||||TWO_SIDED|95.0|1.08|1.21||||||||1.21|1.08|
73813072|NCT01162122|147175578|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H1N1 strain)|9.2|||||TWO_SIDED|95.0|7.1|11.3||||||||11.3|7.1|
73813073|NCT01162122|147175578|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H3N2 strain)|12.7|||||TWO_SIDED|95.0|10.5|14.9||||||||14.9|10.5|
73813074|NCT01162122|147175578|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (B strain)|5.2|||||TWO_SIDED|95.0|3.0|7.4||||||||7.4|3.0|
73813075|NCT01162122|147175579|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|1.37|||||TWO_SIDED|95.0|1.29|1.46||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.46|1.29|
73813076|NCT01162122|147175579|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.6|||||TWO_SIDED|95.0|1.51|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.68|1.51|
73813077|NCT01162122|147175579|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.14|||||TWO_SIDED|95.0|1.08|1.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.2|1.08|
73813078|NCT01162122|147175580|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|8.9|||||TWO_SIDED|95.0|6.9|10.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||10.9|6.9|
73813079|NCT01162122|147175580|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|12.7|||||TWO_SIDED|95.0|10.6|14.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||14.8|10.6|
73813080|NCT01162122|147175580|SUPERIORITY_OR_OTHER||Group difference (B strain)|5.1|||||TWO_SIDED|95.0|2.9|7.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||7.2|2.9|
73813081|NCT01162122|147175584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H1N1 strain)|1.38|||||TWO_SIDED|95.0|1.25|1.52||||||||1.52|1.25|
73813082|NCT01162122|147175584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H3N2 strain)|1.57|||||TWO_SIDED|95.0|1.44|1.72||||||||1.72|1.44|
73813083|NCT01162122|147175584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (B strain)|1.12|||||TWO_SIDED|95.0|1.03|1.21||||||||1.21|1.03|
73813084|NCT01162122|147175585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H1N1 strain)|11.1|||||TWO_SIDED|95.0|7.5|14.6||||||||14.6|7.5|
73813085|NCT01162122|147175585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H3N2 strain)|13.5|||||TWO_SIDED|95.0|9.8|17.2||||||||17.2|9.8|
73813086|NCT01162122|147175585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (B strain)|5.0|||||TWO_SIDED|95.0|1.4|8.5||||||||8.5|1.4|
73813087|NCT01162122|147175586|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|1.32|||||TWO_SIDED|95.0|1.2|1.45||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.45|1.2|
73813088|NCT01162122|147175586|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.54|||||TWO_SIDED|95.0|1.42|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.68|1.42|
73813089|NCT01162122|147175586|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.11|||||TWO_SIDED|95.0|1.03|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.21|1.03|
73813090|NCT01162122|147175590|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|9.9|||||TWO_SIDED|95.0|6.4|13.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||13.3|6.4|
73813091|NCT01162122|147175590|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|13.0|||||TWO_SIDED|95.0|9.5|16.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||16.6|9.5|
73813092|NCT01162122|147175590|SUPERIORITY_OR_OTHER||Group difference (B strain)|4.9|||||TWO_SIDED|95.0|1.5|8.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||8.3|1.5|
73813093|NCT01162122|147175591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (H3N2/Brisbane-overall)|1.45|||||TWO_SIDED|95.0|1.29|1.63||||||||1.63|1.29|
73813094|NCT01162122|147175591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (H3N2/Wisconsin-overall)|1.36|||||TWO_SIDED|95.0|1.23|1.5||||||||1.5|1.23|
73813095|NCT01162122|147175591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was ≥0.67.|GMT Ratio (B strain-overall)|1.09|||||TWO_SIDED|95.0|0.98|1.21||||||||1.21|0.98|
73813096|NCT01162122|147175591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio(H3N2/Brisbane-high risk group)|1.35||||||95.0|1.13|1.61||||||||1.61|1.13|
73813097|NCT01162122|147175591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio(H3N2/Wisconsin-high risk group|1.29|||||TWO_SIDED|95.0|1.1|1.5||||||||1.5|1.1|
73813098|NCT01162122|147175591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (B strain-high risk group)|1.11|||||TWO_SIDED|95.0|0.95|1.3||||||||1.3|0.95|
73813099|NCT01162122|147175592|SUPERIORITY_OR_OTHER||GMT ratio (H3N2/Brisbane-overall)|1.49|||||TWO_SIDED|95.0|1.33|1.67||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.67|1.33|
73813100|NCT01162122|147175592|SUPERIORITY_OR_OTHER||GMT ratio(H3N2/Wisconsin-overall)|1.38|||||TWO_SIDED|95.0|1.25|1.52||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.52|1.25|
73813101|NCT01162122|147175592|SUPERIORITY_OR_OTHER||GMT ratio (B strain-overall)|1.09|||||TWO_SIDED|95.0|0.99|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.21|0.99|
73813102|NCT01162122|147175592|SUPERIORITY_OR_OTHER||GMT ratio (H3N2/Brisbane-high risk)|1.36|||||TWO_SIDED|95.0|1.15|1.61||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.61|1.15|
73813103|NCT01162122|147175592|SUPERIORITY_OR_OTHER||GMT ratio(H3N2/Wisconsin-high risk)|1.28|||||TWO_SIDED|95.0|1.1|1.48||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.48|1.1|
73813104|NCT01162122|147175592|SUPERIORITY_OR_OTHER||GMT ratio (B strain-high risk)|1.13|||||TWO_SIDED|95.0|0.97|1.31||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.31|0.97|
73813105|NCT01162122|147175593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (H3N2/Brisbane-overall)|11.3|||||TWO_SIDED|95.0|6.7|15.9||||||||15.9|6.7|
73813106|NCT01162122|147175593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Wisconsin-overall)|11.9|||||TWO_SIDED|95.0|7.3|16.6||||||||16.6|7.3|
73813107|NCT01162122|147175593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Slope|4.0|||||TWO_SIDED|95.0|-0.4|8.4||||||||8.4|-0.4|
73813108|NCT01162122|147175593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Brisbane-high risk|12.3|||||TWO_SIDED|95.0|4.8|19.9||||||||19.9|4.8|
73813109|NCT01162122|147175593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference(H3N2Wisconsin-high risk|12.6|||||TWO_SIDED|95.0|5.0|20.2||||||||20.2|5.0|
73813110|NCT01162122|147175593|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (B strain-high risk)|4.8|||||TWO_SIDED|95.0|-2.1|11.8||||||||11.8|-2.1|
73813111|NCT01162122|147175594|SUPERIORITY_OR_OTHER||Group difference (H3N2/Brisbane-overall)|12.5|||||TWO_SIDED|95.0|8.1|16.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||16.9|8.1|
73813112|NCT01162122|147175594|SUPERIORITY_OR_OTHER||Group difference(H3N2/Wisconsin-overall)|12.6|||||TWO_SIDED|95.0|8.1|17.1||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||17.1|8.1|
73813113|NCT01162122|147175594|SUPERIORITY_OR_OTHER||Group difference (B strain-overall)|4.6|||||TWO_SIDED|95.0|0.4|8.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||8.8|0.4|
73813114|NCT01162122|147175594|SUPERIORITY_OR_OTHER||Group difference(H3N2/Brisbane-high risk|12.4|||||TWO_SIDED|95.0|5.2|19.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||19.6|5.2|
73813115|NCT01162122|147175594|SUPERIORITY_OR_OTHER||Group difference(H3N2/Wisconsin-highrisk|13.0|||||TWO_SIDED|95.0|5.8|20.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||20.3|5.8|
73813116|NCT01162122|147175594|SUPERIORITY_OR_OTHER||Group difference (B strain-high risk)|5.1|||||TWO_SIDED|95.0|-1.6|11.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||11.8|-1.6|
73813117|NCT03313310|147175614|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.98||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.98
73813118|NCT03313310|147175614|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.05||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.05
73813119|NCT03313310|147175615|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.39||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.39
73813120|NCT03313310|147175615|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.76||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.76
73813121|NCT03313310|147175616|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.|||||<|0.001||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||<0.001
73813122|NCT03313310|147175616|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.02||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.02
73813123|NCT03313310|147175617|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.51||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.51
73813124|NCT03313310|147175617|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.17||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.17
73813125|NCT03313310|147175618|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 8-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
73813126|NCT03313310|147175618|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
73813127|NCT03313310|147175619|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
73813128|NCT03313310|147175619|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.5||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.50
73813129|NCT03313310|147175620|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.63||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.63
73813130|NCT03313310|147175620|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
73813131|NCT03313310|147175621|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
73813132|NCT03313310|147175621|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.25||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.25
73813133|NCT03313310|147175622|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
73813134|NCT03313310|147175622|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
73813135|NCT03313310|147175623|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 8-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
73813136|NCT03313310|147175623|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
73813137|NCT03313310|147175625|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
73813138|NCT03313310|147175625|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
73813139|NCT03313310|147175626|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
73813140|NCT03313310|147175626|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.75||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.75
73813141|NCT03313310|147175627|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.55||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.55
73813142|NCT03313310|147175627|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
73813143|NCT03313310|147175628|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.45||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.45
73813144|NCT03313310|147175628|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.07||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.07
73813145|NCT01217385|147175629|EQUIVALENCE|under the NULL, it is assume that there is no difference between a 40% decrease in TOI, and a less than 40% decrease or an increase in TOI in their ability to predict pCR+|Odds Ratio (OR)|4.667||||0.059|TWO_SIDED|95.0|0.95|23.04||5% alpha threshold for significance.|Regression, Logistic|||"This analysis will look at the ability of the % change in DOSI measured tumor Optical Index (TOI) from baseline to mid-therapy to predict pathologic response using logistic regression.~Pathologic response (dichotomized into responders and non-responders) will be used as the reference standard and %change in TOI ratio (dichotomized at -40%) will be used to estimate pCR (+/-)= alpha + beta1(%change TOI)"||23.04|0.95|0.059
73813146|NCT01217385|147175630|EQUIVALENCE|test for the equivalence of %change in TOI ratio (dichotomized at \<=-40%), between PR+ and PR- groups, with interaction|Slope|0.4463|STANDARD_ERROR_OF_MEAN|1.953||0.8193|TWO_SIDED|||||significance at alpha=0.05|Regression, Logistic|p-value represents the interaction between %TOI (dichotomized at \<=-40%), and PR status|Multivariate logistic regression model using % change in TOI ratio (T/N) (baseline to mid-therapy) dichotomized at -40%, PR status, and the corresponding interaction.|The Null is that the odd ratio is the same in both the PR+ and PR- subjects fro the model including %change in TOI form baseline to mid-therapy (dichotomized at \<=-40%), PR status (+/-) and the interaction between them.||||0.8193
73813147|NCT01217385|147175631|OTHER||Odds Ratio (OR)|16.5||||0.043|TWO_SIDED|95.0|1.09|250.15|||Regression, Logistic|||||250.15|1.09|0.043
73813148|NCT01217385|147175631|OTHER||Odds Ratio (OR)|2.86||||0.406|TWO_SIDED|95.0|0.24|33.9|||Regression, Logistic|||||33.90|0.24|0.406
73813149|NCT00725101|147175654|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||P-value for age over 65.|Regression, Logistic|||||||0.0074
73813150|NCT00725101|147175654|SUPERIORITY_OR_OTHER|||||||0.0028||95.0||||P-value for female physicians.|Regression, Logistic|||||||0.0028
73813151|NCT00725101|147175654|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Rheumatology versus PCP.|Regression, Logistic|||||||<0.0001
73813152|NCT00725101|147175654|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for other specialty versus PCP.|Regression, Logistic|||||||<0.0001
73813153|NCT00725101|147175654|SUPERIORITY_OR_OTHER|||||||0.0064||95.0||||P-value for use of opioids.|Regression, Logistic|||||||0.0064
73813154|NCT00725101|147175654|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for use of NSAIDs.|Regression, Logistic|||||||<0.0001
73813155|NCT00725101|147175654|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for number of medications participants were taking.|Regression, Logistic|||||||<0.0001
73813156|NCT00725101|147175655|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for GAD-7 score.|Regression, Logistic|||||||0.026
73813157|NCT00725101|147175655|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for pregabalin use.|Regression, Logistic|||||||0.021
73813158|NCT00725101|147175655|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for NSAID use.|Regression, Logistic|||||||0.050
73813159|NCT01592292|147175670|SUPERIORITY_OR_OTHER|||||||0.3037||||||Change in DAS28 at Month 6 was performed using analysis of covariance (ANCOVA) model with baseline DAS28 score and rheumatoid factor (RF) status as covariate values.|ANCOVA|||||||0.3037
73813160|NCT01592292|147175671|SUPERIORITY_OR_OTHER|||||||0.0951||||||Change in DAS28 at Month 6 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA|||||||0.0951
73813161|NCT01592292|147175672|SUPERIORITY_OR_OTHER|||||||0.239||||||Change in DAS28 at Month 12 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA|||||||0.2390
73813162|NCT01592292|147175673|SUPERIORITY_OR_OTHER|||||||0.3212||||||Change in TJC at Month 6 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.3212
73813163|NCT01592292|147175673|SUPERIORITY_OR_OTHER|||||||0.7097||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.7097
73813164|NCT01592292|147175674|SUPERIORITY_OR_OTHER|||||||0.2444||||||Change in TJC at Month 6 was performed using ANCOVA with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2444
73813165|NCT01592292|147175674|SUPERIORITY_OR_OTHER|||||||0.3903||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.3903
73813166|NCT01592292|147175675|SUPERIORITY_OR_OTHER|||||||0.5306||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.5306
73813167|NCT01592292|147175675|SUPERIORITY_OR_OTHER|||||||0.2542||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2542
73813168|NCT01592292|147175676|SUPERIORITY_OR_OTHER|||||||0.2549||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2549
73813169|NCT01592292|147175676|SUPERIORITY_OR_OTHER|||||||0.7644||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.7644
73813170|NCT01592292|147175677|SUPERIORITY_OR_OTHER|||||||0.8987||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA|||||||0.8987
73813171|NCT01592292|147175677|SUPERIORITY_OR_OTHER|||||||0.5808||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA|||||||0.5808
73813172|NCT01592292|147175678|SUPERIORITY_OR_OTHER|||||||0.2282||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2282
73813173|NCT01592292|147175678|SUPERIORITY_OR_OTHER|||||||0.5849||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.5849
73813174|NCT01592292|147175679|SUPERIORITY_OR_OTHER|||||||0.49||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.4900
73813175|NCT01592292|147175679|SUPERIORITY_OR_OTHER|||||||0.1826||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1826
73813176|NCT01592292|147175680|SUPERIORITY_OR_OTHER|||||||0.1894||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1894
73813177|NCT01592292|147175680|SUPERIORITY_OR_OTHER|||||||0.1805||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1805
73813178|NCT01592292|147175681|SUPERIORITY_OR_OTHER|||||||0.0568||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA|||||||0.0568
73813179|NCT01592292|147175682|SUPERIORITY_OR_OTHER|||||||0.1167||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA|||||||0.1167
73813180|NCT03660475|147175709|SUPERIORITY|||||||0.967|||||||t-test, 2 sided|||||||0.967
73813181|NCT03660475|147175710|SUPERIORITY|||||||0.836|||||||t-test, 2 sided|||||||0.836
73813182|NCT03660475|147175711|SUPERIORITY|||||||0.166|||||||t-test, 2 sided|||||||0.166
73813183|NCT03660475|147175712|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|||||||0.638
73813184|NCT03660475|147175713|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||0.122
73813185|NCT03660475|147175714|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.200
73813186|NCT03660475|147175715|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||||||0.085
73813187|NCT03660475|147175717|SUPERIORITY|||||||0.903|||||||t-test, 2 sided|||||||0.903
73813188|NCT03660475|147175718|SUPERIORITY|||||||0.898|||||||t-test, 2 sided|||||||0.898
73813189|NCT03660475|147175719|SUPERIORITY|||||||0.221|||||||t-test, 2 sided|||||||0.221
73813190|NCT03660475|147175720|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||||||0.459
73813191|NCT02889835|147175741|SUPERIORITY|||||||0.686|||||||Log Rank|||Kaplan-Meier analysis was performed to assess survival over 36 months. Test of survival distributions for the three arms were calculated using Log Rank (Mantel-Cox). Sample size is based on guidelines of the American Dental Association for obtaining approval as an amalgam replacement for posterior restorations - minimum of 40 restorations in a minimum of 20 subjects at 18 months. Sample size is based by taking subject attrition into account over the 36 month clinical evaluation.||||0.686
73813192|NCT02889835|147175742|SUPERIORITY|||||||0.701|||||||Kruskal-Wallis|||||||0.701
73813193|NCT02889835|147175743|SUPERIORITY|||||||0.812|||||||Kruskal-Wallis|||||||0.812
73813194|NCT02889835|147175744|SUPERIORITY|||||||0.104|||||||Kruskal-Wallis|||||||0.104
73813195|NCT02889835|147175745|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.440
73813196|NCT02889835|147175746|SUPERIORITY|||||||0.676|||||||Kruskal-Wallis|||||||0.676
73813197|NCT02889835|147175747|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.000
73813198|NCT02889835|147175748|SUPERIORITY|||||||0.764|||||||Kruskal-Wallis|||||||0.764
73813199|NCT02889835|147175749|SUPERIORITY|||||||0.323|||||||Kruskal-Wallis|||||||0.323
73813200|NCT02889835|147175750|SUPERIORITY|||||||0.714|||||||Kruskal-Wallis|||||||0.714
73813201|NCT02889835|147175751|SUPERIORITY|||||||0.846|||||||Kruskal-Wallis|||||||0.846
73813202|NCT02889835|147175752|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.000
73813203|NCT02889835|147175753|SUPERIORITY|||||||0.424|||||||Kruskal-Wallis|||||||0.424
73813204|NCT00224406|147175756|SUPERIORITY||Mean Difference (Final Values)|5.022||||0.8541|ONE_SIDED|95.0||50.26|||t-test, 1 sided|||Repeated Measurements Analysis of PaO2/FiO2 ratio corrected for the altitude at 0 and 24hours after ICU admission using a one-sided test excluding missing data. Herein analysis at ICU Admission (Time 0).||50.26||0.8541
73813205|NCT00224406|147175756|SUPERIORITY||Mean Difference (Final Values)|10.426||||0.6996|ONE_SIDED|95.0||55.17|||t-test, 1 sided|||Repeated Measurements Analysis of PaO2/FiO2 ratio corrected for the altitude at 0 and 24hours after ICU admission using a one-sided test excluding missing data. Herein analysis at 24 Hours Post ICU Admission.||55.17||0.6996
73813206|NCT00224406|147175757|SUPERIORITY||Mean Difference (Final Values)|4.377||||0.8654|ONE_SIDED|95.0||47.15|||t-test, 1 sided|||ICU Admission (Time 0)||47.15||0.8654
73813207|NCT00224406|147175757|SUPERIORITY||Median Difference (Final Values)|13.386||||0.6789|ONE_SIDED|95.0||66.91|||t-test, 1 sided|||24 Hours Post ICU Admission||66.91||0.6789
73813208|NCT00224406|147175757|SUPERIORITY||Mean Difference (Final Values)|-19.968||||0.6345|ONE_SIDED|95.0||49.56|||t-test, 1 sided|||48 Hours Post ICU Admission||49.56||0.6345
73813209|NCT00224406|147175757|SUPERIORITY||Mean Difference (Final Values)|0.908||||0.9858|ONE_SIDED|95.0||85.49|||t-test, 1 sided|||72 Hours Post ICU Admission||85.49||0.9858
73813210|NCT00224406|147175758|SUPERIORITY||Odds Ratio (OR)|2.867||||0.7985|TWO_SIDED|95.0|0.727|11.302|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at ICU Admission (Time 0). One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||11.302|0.727|0.7985
73813211|NCT00224406|147175758|SUPERIORITY||Odds Ratio (OR)|0.837||||0.5606|TWO_SIDED|95.0|0.226|3.092|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 24h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||3.092|0.226|0.5606
73813212|NCT00224406|147175758|SUPERIORITY||Odds Ratio (OR)|1.716||||0.8786|TWO_SIDED|95.0|0.531|5.552|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 48h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||5.552|0.531|0.8786
73813213|NCT00224406|147175758|SUPERIORITY||Odds Ratio (OR)|1.337||||0.8499|TWO_SIDED|95.0|0.352|5.072|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 72h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||5.072|0.352|0.8499
73813214|NCT00224406|147175759|SUPERIORITY|at 24 hrs from mechanical ventilation|difference in event probability|0.0091||||0.7076|TWO_SIDED|95.0|-0.1867|0.2049|||Log Rank|||||0.2049|-0.1867|0.7076
73813215|NCT00224406|147175759|SUPERIORITY||difference in event probability|-0.0316||||0.7076|TWO_SIDED|95.0|-0.2092|0.146|||Log Rank|||at 48 hrs from mechanical ventilation||0.1460|-0.2092|0.7076
73813216|NCT00224406|147175759|SUPERIORITY||difference in event probability|-0.0661||||0.7076|TWO_SIDED|95.0|-0.2314|0.0993|||Log Rank|||at 72 hrs from mechanical ventilation||0.0993|-0.2314|0.7076
73813217|NCT00224406|147175760|SUPERIORITY||Difference in event probability|-0.0364||||0.9632|TWO_SIDED|95.0|-0.0858|0.0131|||Log Rank|||Analysis at 24 hours||0.0131|-0.0858|0.9632
73813218|NCT00224406|147175760|SUPERIORITY||Difference in event probability|0.0352||||0.9632|TWO_SIDED|95.0|-0.1458|0.2162|||Log Rank|||Analysis at 48 h||0.2162|-0.1458|0.9632
73813219|NCT00224406|147175760|SUPERIORITY||Difference in event probability|-0.0179||||0.9632|TWO_SIDED|95.0|-0.2143|0.1785|||Log Rank|||analysis at 72 h||0.1785|-0.2143|0.9632
73813220|NCT00224406|147175765|SUPERIORITY||Difference in event probability|-0.0566||||0.0111|TWO_SIDED|95.0|-0.1188|0.0056|||Log Rank|||Herein analysis up to month 3 was reported.||0.0056|-0.1188|0.0111
73813221|NCT00224406|147175765|SUPERIORITY||Difference in event probability|-0.0943||||0.0111|TWO_SIDED|95.0|-0.173|-0.0156|||Log Rank|||Herein analysis up to month 6 was reported.||-0.0156|-0.1730|0.0111
73813222|NCT00224406|147175765|SUPERIORITY||Difference in event probability|-0.1132||||0.0111|TWO_SIDED|95.0|-0.1985|-0.0279|||Log Rank|||Herein analysis up to month 9 was reported.||-0.0279|-0.1985|0.0111
73813223|NCT00224406|147175765|SUPERIORITY||Slope|-0.1334||||0.0111|TWO_SIDED|95.0|-0.2254|-0.0413|||Log Rank|||Herein analysis up to month 12 was reported.||-0.0413|-0.2254|0.0111
73813224|NCT01556997|147175768|SUPERIORITY_OR_OTHER|||||||0.025|ONE_SIDED|||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (\<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA|||||||0.025
73813225|NCT01556997|147175769|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (\<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA|||||||0.025
73813226|NCT01010009|147175772|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.||||>0.05
73813227|NCT01010009|147175772|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.||||<0.05
73813228|NCT01010009|147175773|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.||||>0.05
73813229|NCT01010009|147175773|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.||||>0.05
73813230|NCT01010009|147175774|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.||||<0.05
73813231|NCT01010009|147175774|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.||||<0.05
73813232|NCT05459558|147175779|SUPERIORITY||||||<|0.0001||||||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
73813233|NCT05459558|147175779|SUPERIORITY||||||<|0.0001||||||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
73813234|NCT05459558|147175780|SUPERIORITY||||||<|0.0001|||||||Mixed Models with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
73813235|NCT05459558|147175780|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
73813236|NCT05459558|147175781|SUPERIORITY||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-1.88|-1.62|||Mixed Model with Repeated Measures|||Week 4||-1.62|-1.88|<0.0001
73813237|NCT05459558|147175781|SUPERIORITY||Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-1.87|-1.61|||Mixed Model with Repeated Measures|||Week 4||-1.61|-1.87|<0.0001
73813238|NCT05459558|147175781|SUPERIORITY||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|-2.08|-1.81||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.81|-2.08|<0.0001
73813239|NCT05459558|147175781|SUPERIORITY||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|-2.18|-1.9||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.90|-2.18|<0.0001
73813240|NCT05459558|147175782|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-1.0|-0.62|||Mixed Model with Repeated Measures|||Week 4||-0.62|-1.00|<0.0001
73813241|NCT05459558|147175782|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.79|-0.41|||Mixed Model with Repeated Measures|||Week 4||-0.41|-0.79|<0.0001
73813242|NCT05459558|147175782|SUPERIORITY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.06|-1.31||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.31|-2.06|<0.0001
73813243|NCT05459558|147175782|SUPERIORITY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-2.19|-1.44||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.44|-2.19|<0.0001
73813244|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-2.41|-2.05|||Mixed Model with Repeated Measures|||Gingival Sites, Week 4||-2.05|-2.41|<0.0001
73813245|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-2.41|-2.05|||Mixed Model with Repeated Measures|||Gingival Sites, Week 4||-2.05|-2.41|<0.0001
73813246|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-2.69|-2.31|||Mixed Model with Repeated Measures|||Gingival Sites, Week 8||-2.31|-2.69|<0.0001
73813247|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-2.81|-2.44|||Mixed Model with Repeated Measures|||Gingival Sites, Week 8||-2.44|-2.81|<0.0001
73813248|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001|TWO_SIDED|95.0|-2.22|-1.91|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 4||-1.91|-2.22|<0.0001
73813249|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001|TWO_SIDED|95.0|-2.2|-1.89|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 4||-1.89|-2.20|<0.0001
73813250|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-2.45|-2.13|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 8||-2.13|-2.45|<0.0001
73813251|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|0.082|<|0.0001|TWO_SIDED|95.0|-2.57|-2.25|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 8||-2.25|-2.57|<0.0001
73813252|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.76|-0.5|||Mixed Model with Repeated Measures|||Body Sites, Week 4||-0.50|-0.76|<0.0001
73813253|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.77|-0.51|||Mixed Model with Repeated Measures|||Body Sites, Week 4||-0.51|-0.77|<0.0001
73813254|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.81|-0.57|||Mixed Model with Repeated Measures|||Body Sites, Week 8||-0.57|-0.81|<0.0001
73813255|NCT05459558|147175783|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.81|-0.57|||Mixed Model with Repeated Measures|||Body Sites, Week 8||-0.57|-0.81|<0.0001
73813256|NCT05459558|147175784|SUPERIORITY||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.97|-0.82|||Mixed Model with Repeated Measures|||Area, Week 4||-0.82|-0.97|<0.0001
73813257|NCT05459558|147175784|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.95|-0.79|||Mixed Model with Repeated Measures|||Area, Week 4||-0.79|-0.95|<0.0001
73813258|NCT05459558|147175784|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|-1.15|-1.01|||Mixed Model with Repeated Measures|||Area, Week 8||-1.01|-1.15|<0.0001
73813259|NCT05459558|147175784|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|-1.22|-1.07|||Mixed Model with Repeated Measures|||Area, Week 8||-1.07|-1.22|<0.0001
73813260|NCT05459558|147175784|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|-0.93|-0.8|||Mixed Model with Repeated Measures|||Intensity, Week 4||-0.80|-0.93|<0.0001
73813261|NCT05459558|147175784|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|-0.93|-0.8|||Mixed Model with Repeated Measures|||Intensity, Week 4||-0.80|-0.93|<0.0001
73813262|NCT05459558|147175784|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-1.04|-0.9|||Mixed Model with Repeated Measures|||Intensity, Week 8||-0.90|-1.04|<0.0001
73813263|NCT05459558|147175784|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-1.08|-0.95|||Mixed Model with Repeated Measures|||Intensity, Week 8||-0.95|-1.08|<0.0001
73813264|NCT03292458|147175833|SUPERIORITY|The primary efficacy outcome was analyzed using a restricted maximum likelihood (REML)-based linear mixed-effect model. The analysis included group, treatment, and treatment period as interacting fixed effects and subject as random effect. An unstructured covariance structure was used to model the within-patient errors.||||||0.01|TWO_SIDED|98.75|||||Mixed Models Analysis|||||||0.01
73813265|NCT03292458|147175834|OTHER|The minimum and average efficacy (in % symptom change) of sodium oxybate versus placebo in improving symptoms compared to the baseline was determined using binomial logistic regression.||||||0.05|TWO_SIDED|98.75|||||Regression, Logistic|||The minimum and average efficacy of sodium oxybate vs. placebo in improving symptoms compared to the baseline were determined using binomial logistic regression.||||0.05
73813266|NCT03292458|147175835|OTHER||Mean Difference (Final Values)|98.75||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
73813267|NCT03292458|147175836|OTHER|||||||0.01|TWO_SIDED|98.75|||||ANOVA|||||||0.01
73813268|NCT03292458|147175837|OTHER|||||||0.01|TWO_SIDED|98.75|||||Pearson correlation|||||||0.01
73813269|NCT03292458|147175838|OTHER|||||||0.01|TWO_SIDED|98.75|||||Pearson correlation|||||||0.01
73813270|NCT05070468|147175938|SUPERIORITY|||||||0.618|||||||Wilcoxon (Mann-Whitney)|||||||0.618
73813271|NCT05070468|147175939|SUPERIORITY|||||||0.483|||||||Wilcoxon (Mann-Whitney)|||||||0.483
73813272|NCT05070468|147175940|SUPERIORITY|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||||||0.571
73813273|NCT00308750|147175941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Log Rank|||||||0.40
73813274|NCT00308750|147175941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Log Rank|||||||0.19
73813275|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||||||P-value is for the change in Total FACT-L at Cycle 1 (Week 3).|ANCOVA|||||||0.96
73813276|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||P-value is for the change in Total FACT-L at Cycle 1 (Week 3).|ANCOVA|||||||0.15
73813277|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||P-value is for the change in Total FACT-L at Cycle 2 (Week 6).|ANCOVA|||||||0.92
73813278|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||||||P-value is for the change in Total FACT-L at Cycle 2 (Week 6).|ANCOVA|||||||0.97
73813279|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||P-value is for the change in Total FACT-L at Cycle 3 (Week 9).|ANCOVA|||||||0.71
73813280|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66||||||P-value is for the change in Total FACT-L at Cycle 3 (Week 9).|ANCOVA|||||||0.66
73813281|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||||||P-value is for the change in Total FACT-L at Cycle 4 (Week 12).|ANCOVA|||||||0.93
73813282|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33||||||P-value is for the change in Total FACT-L at Cycle 4 (Week 12).|ANCOVA|||||||0.33
73813283|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||P-value is for the change in Total FACT-L at Cycle 5 (Week 15).|ANCOVA|||||||0.19
73896359|NCT00412373|147326172|SUPERIORITY_OR_OTHER||LS Means Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.4|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.7|-6.4|<0.001
73813284|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||P-value is for the change in Total FACT-L at Cycle 5 (Week 15).|ANCOVA|||||||0.40
73813285|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||||||P-value is for the change in Total FACT-L at Cycle 6 (Week 18).|ANCOVA|||||||0.63
73813286|NCT00308750|147175945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||P-value is for the change in Total FACT-L at Cycle 6 (Week 18).|ANCOVA|||||||0.55
73813287|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||||||P-value is for the change in Total FACT-Taxane at Cycle 1 (Week 3).|ANCOVA|||||||0.93
73813288|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||P-value is for the change in Total FACT-Taxane at Cycle 1 (Week 3).|ANCOVA|||||||0.86
73813289|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||||||P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6).|ANCOVA|||||||0.69
73813290|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6).|ANCOVA|||||||0.77
73813291|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83||||||P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9).|ANCOVA|||||||0.83
73813292|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||||||P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9).|ANCOVA|||||||0.78
73813293|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12).|ANCOVA|||||||1.00
73813294|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12).|ANCOVA|||||||0.91
73813295|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49||||||P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15).|ANCOVA|||||||0.49
73813296|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||||||P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15).|ANCOVA|||||||0.53
73813297|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||||||P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18).|ANCOVA|||||||0.80
73813298|NCT00308750|147175946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85||||||P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18).|ANCOVA|||||||0.85
73813299|NCT00308750|147175947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87|||||||Log Rank|||||||0.87
73813300|NCT00308750|147175947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Log Rank|||||||0.05
73813301|NCT00308750|147175950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Log Rank|||||||0.71
73813302|NCT00308750|147175950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Log Rank|||||||0.04
73813303|NCT02304380|147175965|OTHER||Difference in differences|-0.0064|||||TWO_SIDED|95.0|-0.0469|0.034|||||Linear model difference in incidences.|||0.0340|-0.0469|
73813304|NCT02304380|147175966|OTHER||Difference in Differences|0.0506|||||TWO_SIDED|95.0|0.029|0.0722|||||Linear model difference in incidences.|||0.0722|0.0290|
73813305|NCT02304380|147175967|OTHER||Difference in Differences|-0.0005|||||TWO_SIDED|95.0|-0.0109|0.0099|||||Linear model difference in incidences.|||0.0099|-0.0109|
73813306|NCT02304380|147175968|OTHER||Difference in differences|-0.0207|||||TWO_SIDED|95.0|-0.0318|0.0096||||||||0.0096|-0.0318|
73813307|NCT02304380|147175969|OTHER||Difference in differences|0.0163|||||TWO_SIDED|95.0|0.0036|0.0289|||||Linear model difference in incidences.|||0.0289|0.0036|
73813308|NCT02304380|147175970|OTHER||Difference in differences|0.0046|||||TWO_SIDED|95.0|-0.002|0.0111|||||||Linear model difference in incidences.|0.0111|-0.0020|
73813309|NCT02304380|147175971|OTHER||Difference in differences|0.0151|||||TWO_SIDED|95.0|-0.0129|0.0431|||||Linear model difference in incidences.|||0.0431|-0.0129|
73813310|NCT02304380|147175972|OTHER||Difference in Differences|-0.0066|||||TWO_SIDED|95.0|-0.0328|0.0197|||||Linear model difference in incidences.|||0.0197|-0.0328|
73813311|NCT02304380|147175973|OTHER||Difference in Differences|-0.0105|||||TWO_SIDED|95.0|-0.0374|0.0163|||||Linear model difference in incidences.|||0.0163|-0.0374|
73813312|NCT02304380|147175974|OTHER||Difference in Differences|0.0006|||||TWO_SIDED|95.0|-0.0031|0.0044|||||Linear model difference in incidences.|||0.0044|-0.0031|
73813313|NCT02304380|147175975|OTHER||Difference in Differences|-0.0293|||||TWO_SIDED|95.0|-0.1025|0.044||||Linear model difference in incidences.||||0.0440|-0.1025|
73813314|NCT02304380|147175976|OTHER||Difference in Differences|-0.0579|||||TWO_SIDED|95.0|-0.1492|0.0116|||||Linear model difference in incidences.|||0.0116|-0.1492|
73813315|NCT02304380|147175977|OTHER||Difference in differences|0.0072|||||TWO_SIDED|95.0|0.001|0.0134|||||Linear model difference in incidences.|||0.0134|0.0010|
73813316|NCT02304380|147175978|OTHER||Difference in Differences|0.0058|||||TWO_SIDED|95.0|0.0009|0.0107||||||||0.0107|0.0009|
73813317|NCT02304380|147175979|OTHER||Difference in Differences|0.0054|||||TWO_SIDED|95.0|0.0001|0.0106|||||Linear model difference in incidences.|||0.0106|0.0001|
73813318|NCT02304380|147175980|OTHER||Difference in Differences|-0.0039|||||TWO_SIDED|95.0|-0.0096|0.0017|||||Linear model difference in incidences.|||0.0017|-0.0096|
73813319|NCT02304380|147175981|OTHER||Difference in Differences|-0.011|||||TWO_SIDED|95.0|-0.0178|-0.0043|||||Linear model difference in incidences.|||-0.0043|-0.0178|
73813320|NCT02304380|147175982|OTHER||Difference in Differences|0.0026|||||TWO_SIDED|95.0|-0.0036|0.0086|||||Linear model difference in incidences.|||0.0086|-0.0036|
73813321|NCT02304380|147175983|OTHER||Difference in differences|0.0197|||||TWO_SIDED|95.0|0.011|0.0284|||||Linear model difference in incidences.|||0.0284|0.0110|
73813322|NCT02327013|147175986|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.8||0.9723|TWO_SIDED|95.0|-3.6|3.5|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.||The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.||3.5|-3.6|0.9723
73813323|NCT02327013|147175986|SUPERIORITY|The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.9||0.601|TWO_SIDED|95.0|-2.8|4.8|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.||||4.8|-2.8|0.6010
73813324|NCT04108988|147176057|SUPERIORITY|||||||0.248|||||||Chi-squared|||P value at 4 months||||0.248
73813325|NCT04108988|147176057|SUPERIORITY|||||||0.022|||||||Chi-squared|||P value at 1 month||||0.022
73813326|NCT04108988|147176057|SUPERIORITY|||||||0.193|||||||Chi-squared|||P value at baseline||||0.193
73813327|NCT04108988|147176058|SUPERIORITY|||||||0.246|||||||Chi-squared|||P value at 4 months||||0.246
73813328|NCT04108988|147176058|SUPERIORITY|||||||0.467|||||||Chi-squared|||P value at 1 month||||0.467
73813329|NCT04108988|147176058|SUPERIORITY|||||||0.55|||||||Chi-squared|||P value at baseline||||0.550
73813330|NCT04108988|147176059|SUPERIORITY|||||||0.596|||||||Chi-squared|||P value at month 4||||0.596
73813331|NCT04108988|147176059|SUPERIORITY|||||||0.974|||||||Chi-squared|||P value at 1 month||||0.974
73813332|NCT04108988|147176059|SUPERIORITY|||||||0.651|||||||Chi-squared|||P value at baseline.||||0.651
73813333|NCT04108988|147176060|SUPERIORITY|||||||0.089|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.089
73813334|NCT04108988|147176061|SUPERIORITY|||||||0.095|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.095
73813335|NCT04108988|147176062|SUPERIORITY|||||||0.136|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.136
73813336|NCT04108988|147176063|SUPERIORITY|||||||0.133|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.133
73813337|NCT04108988|147176064|SUPERIORITY|||||||0.21|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.210
73813338|NCT04108988|147176065|SUPERIORITY|||||||0.392|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.392
73813339|NCT04108988|147176066|SUPERIORITY|||||||0.411|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.411
73813340|NCT04108988|147176067|SUPERIORITY|||||||0.294|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.294
73813341|NCT04108988|147176068|SUPERIORITY|||||||0.031|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.031
73813342|NCT04108988|147176069|SUPERIORITY|||||||0.262|||||||ANOVA|Test for the interaction between treatment and time||Test of interaction with treatment and time.||||0.262
73813343|NCT04108988|147176070|SUPERIORITY|||||||0.116|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.116
73813344|NCT04108988|147176071|SUPERIORITY|||||||0.016|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.016
73813345|NCT04108988|147176072|SUPERIORITY|||||||0.667|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.667
73813346|NCT04108988|147176073|SUPERIORITY|||||||0.09|||||||Chi-squared|||P value at month 4||||0.09
73813347|NCT04108988|147176073|SUPERIORITY|||||||0.72|||||||Chi-squared|||P value 1 month||||0.72
73813348|NCT04108988|147176073|SUPERIORITY|||||||0.97|||||||Chi-squared|||P value at baseline||||0.97
73813349|NCT04108988|147176074|SUPERIORITY|||||||0.53|||||||Chi-squared|||P value at month 4||||0.53
73813350|NCT04108988|147176074|SUPERIORITY|||||||0.303|||||||Chi-squared|||P value at month 1||||0.303
73813351|NCT04108988|147176074|SUPERIORITY|||||||0.042|||||||Chi-squared|||P value at baseline.||||0.042
73813352|NCT04108988|147176075|SUPERIORITY|||||||0.246|||||||Chi-squared|||P value at month 4.||||0.246
73813353|NCT04108988|147176075|SUPERIORITY|||||||0.467|||||||Chi-squared|||P value at month 1.||||0.467
73813354|NCT04108988|147176075|SUPERIORITY|||||||0.55|||||||Chi-squared|||P value at baseline.||||0.55
73813355|NCT04108988|147176076|SUPERIORITY|||||||0.987|||||||Chi-squared|||P value at month 4.||||0.987
73813356|NCT04108988|147176076|SUPERIORITY|||||||0.898|||||||Chi-squared|||P value at month 1.||||0.898
73813357|NCT04108988|147176076|SUPERIORITY|||||||0.238|||||||Chi-squared|||P value at baseline.||||0.238
73813358|NCT04108988|147176077|SUPERIORITY|||||||0.148|||||||Chi-squared|||P value at month 4.||||0.148
73813359|NCT04108988|147176077|SUPERIORITY|||||||0.557|||||||Chi-squared|||P value at month 1.||||0.557
73813360|NCT04108988|147176078|SUPERIORITY|||||||0.653|||||||Chi-squared|||||||0.653
73813361|NCT04108988|147176079|SUPERIORITY|||||||0.977|||||||Chi-squared|||||||0.977
73813362|NCT04108988|147176080|SUPERIORITY|||||||0.735|||||||t-test, 2 sided|||P value at month 4.||||0.735
73813363|NCT04108988|147176080|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||P value at month 1.||||0.159
73813364|NCT04108988|147176081|SUPERIORITY|||||||3.19|||||||t-test, 2 sided|||P value at month 4.||||3.19
73813365|NCT04108988|147176081|SUPERIORITY|||||||0.487|||||||t-test, 2 sided|||P value at month 1.||||0.487
73813366|NCT04108988|147176081|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||P value at baseline.||||0.165
73813367|NCT04108988|147176082|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||P value at month 4.||||0.473
73813368|NCT04108988|147176082|SUPERIORITY|||||||0.316|||||||t-test, 2 sided|||P value at month 1.||||0.316
73813369|NCT04108988|147176082|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||P value at baseline.||||0.345
73813370|NCT04108988|147176083|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||P value at month 4.||||0.141
73813371|NCT04108988|147176083|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||P value at month 1.||||0.314
73813372|NCT04108988|147176083|SUPERIORITY|||||||0.444|||||||t-test, 2 sided|||P value at baseline.||||0.444
73813373|NCT01642485|147176100|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||The effect of insulin, C-peptide and glucose on QTcF was investigated using linear mixed effect concentration-response models with the double difference of QTcF (difference to time matched placebo of the change from average baseline) as dependent variable and up to two of the variables change from time matched placebo in insulin, C-peptide and glucose as covariates.||||0.05
73813374|NCT01642485|147176101|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||The relevant confirmatory null hypotheses could all be rejected on the 5% level (one sided), i.e. a difference in QTcF between continental breakfast and placebo; between FDA breakfast and placebo could be ascertained.||||0.05
73813375|NCT01642485|147176101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|||||TWO_SIDED|90.0|-10.4|-5.5||||||||-5.5|-10.4|
73813376|NCT01642485|147176101|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.8|||||TWO_SIDED|90.0|-9.3|-4.3||||||||-4.3|-9.3|
73813377|NCT04007107|147176136|OTHER|Comparison|Estimated treatment difference|30.7|||<|0.0001|TWO_SIDED|95.0|26.6|34.8|||ANOVA|||The intensity of pain was analysed by a fixed analysis of variance model with VAS score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||34.8|26.6|<0.0001
73813378|NCT04068688|147176141|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
73813379|NCT04068688|147176141|OTHER|||||||0.914|||||||Wilcoxon (Mann-Whitney)|||||||0.914
73813380|NCT04068688|147176142|OTHER|||||||0.655|||||||Wilcoxon (Mann-Whitney)|||||||0.655
73813381|NCT04068688|147176142|OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||||||0.564
73813382|NCT04068688|147176143|OTHER|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
73813383|NCT04068688|147176143|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||||||0.705
73813384|NCT04068688|147176144|OTHER|||||||0.096|||||||Wilcoxon (Mann-Whitney)|||||||0.096
73813385|NCT04068688|147176144|OTHER|||||||0.732|||||||Wilcoxon (Mann-Whitney)|||||||0.732
73813386|NCT04068688|147176145|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
73813387|NCT04068688|147176145|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||||||0.705
73813388|NCT04068688|147176146|OTHER|||||||0.442|||||||Wilcoxon (Mann-Whitney)|||||||0.442
73813389|NCT04068688|147176146|OTHER|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||||||0.458
73813390|NCT04068688|147176147|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
73813391|NCT04068688|147176147|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
73813392|NCT04068688|147176151|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73813393|NCT04068688|147176152|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
73813394|NCT04068688|147176153|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
73813395|NCT04068688|147176153|OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
73813396|NCT04068688|147176154|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
73813397|NCT04068688|147176154|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
73813398|NCT04068688|147176158|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73813399|NCT04068688|147176158|OTHER|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.139
73813400|NCT04679051|147176163|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||Two-tailed paired t-tests were used to compare variables between time in bed conditions.||||0.36
73813401|NCT04679051|147176164|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Paired t-test comparing the two time in bed protocols.||||0.51
73813402|NCT04679051|147176165|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Paired t-test comparing peak forearm blood flow between sleep protocols.||||0.03
73813403|NCT04679051|147176166|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Paired t-test used to compare carotid-femoral pulse wave velocity (index of arterial stiffness) between sleep protocols.||||0.29
73813404|NCT04679051|147176167|SUPERIORITY||||||<|0.001||||||Null hypothesis is that there was no difference in change of spatial ability following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on Manikin throughput scores.||||<0.001
73813405|NCT04679051|147176168|SUPERIORITY|||||||0.04||||||Null hypothesis is that there was no difference in the change of executive function following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on the number of correct answers during a Stroop color-word test.||||0.04
73813406|NCT04679051|147176169|SUPERIORITY|||||||0.02||||||Null hypothesis is that there was no difference in change of spatial ability following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on throughput scores from a Switching task.||||0.02
73813407|NCT01273155|147176185|OTHER|Belinostat|Kendall's Tau|0.096||||0.327|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.327
73813408|NCT01273155|147176185|OTHER|Belinostat glucuronide|Kendall's Tau|-0.178||||0.063|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.063
73813409|NCT01273155|147176185|OTHER|Methyl belinostat|Kendall's Tau|0.382|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
73813410|NCT01273155|147176185|OTHER|M21|Kendall's Tau|0.253||||0.009|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.009
73813411|NCT01273155|147176185|OTHER|M24|Kendall's Tau|-0.278||||0.004|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.004
73813412|NCT01273155|147176185|OTHER|M26|Kendall's Tau|0.098||||0.312|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.312
73813413|NCT01273155|147176186|OTHER|Belinostat|Kendall's Tau|0.215||||0.025|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.025
73813414|NCT01273155|147176186|OTHER|Methyl belinostat|Kendall's Tau|0.426|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
73813415|NCT01273155|147176186|OTHER|M21|Kendall's Tau|0.337|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
73813416|NCT01273155|147176186|OTHER|M24|Kendall's Tau|-0.061||||0.524|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.524
73813417|NCT01273155|147176186|OTHER|M26|Kendall's Tau|0.246||||0.01|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.010
73813418|NCT01273155|147176187|OTHER||Kendall's Tau|0.057||||0.548|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.548
73813419|NCT01273155|147176188|OTHER|Belinostat|Kendall's Tau|0.091||||0.34|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.340
73813420|NCT01273155|147176188|OTHER|Belinostat glucuronide|Kendall's Tau|-0.216||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
73813421|NCT01273155|147176188|OTHER|Methyl belinostat|Kendall's Tau|0.268||||0.005|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.005
73813422|NCT01273155|147176188|OTHER|M21|Kendall's Tau|0.242||||0.011|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.011
73813423|NCT01273155|147176188|OTHER|M24|Kendall's Tau|-0.114||||0.231|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.231
73813424|NCT01273155|147176188|OTHER|M26|Kendall's Tau|0.22||||0.021|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.021
73813425|NCT01273155|147176189|OTHER||Kendall's Tau|-0.216||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
73813426|NCT01273155|147176190|OTHER||Kendall's Tau|0.06||||0.531|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.531
73813427|NCT01273155|147176191|OTHER|Belinostat glucuronide/belinostat|Kendall's Tau|-0.224||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
73813428|NCT01273155|147176191|OTHER|Methyl belinostat/belinostat|Kendall's Tau|0.295||||0.011|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.011
73813429|NCT01273155|147176191|OTHER|M21/belinostat|Kendall's Tau|0.335||||0.004|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.004
73813430|NCT01273155|147176191|OTHER|M24/belinostat|Kendall's Tau|-0.24||||0.037|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.037
73813431|NCT01273155|147176191|OTHER|M26/belinostat|Kendall's Tau|0.127||||0.275|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.275
73813432|NCT01273155|147176191|OTHER|M24/M26|Kendall's Tau|-0.308||||0.002|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.002
73813433|NCT01273155|147176191|OTHER|M26/M21|Kendall's Tau|-0.159||||0.095|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.095
73813434|NCT01273155|147176192|OTHER|Belinostat glucuronide/belinostat|Kendall's Tau|-0.055||||0.568|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.568
73813435|NCT01273155|147176192|OTHER|Methyl belinostat/belinostat|Kendall's Tau|0.38|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
73813436|NCT01273155|147176192|OTHER|M21/belinostat|Kendall's Tau|0.315||||0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.001
73813437|NCT01273155|147176192|OTHER|M24/belinostat|Kendall's Tau|-0.205||||0.037|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.037
73813438|NCT01273155|147176192|OTHER|M26/belinostat|Kendall's Tau|0.218||||0.033|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.033
73813439|NCT01273155|147176192|OTHER|M24/M26|Kendall's Tau|-0.309||||0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.001
73813440|NCT01273155|147176192|OTHER|M26/M21|Kendall's Tau|-0.205||||0.032|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.032
73813441|NCT01438814|147176195|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test relative to 0.35|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|||||0.12|-0.13|<0.0001
73813442|NCT01438814|147176195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8924||95.0|-0.13|0.12|||ANCOVA|||||0.12|-0.13|0.8924
73813443|NCT01438814|147176196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8201||95.0|0.672|1.37|||Regression, Logistic|Model includes treatment and continuous baseline HbA1c||||1.370|0.672|0.8201
73813444|NCT01438814|147176197|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.022||||0.9397|TWO_SIDED|95.0|0.582|1.796|||Regression, Logistic|Model includes treatment and baseline HbA1c.||||1.796|0.582|0.9397
73813445|NCT01438814|147176198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.1||0.3352||95.0|-2.1|6.1|||ANCOVA|||||6.1|-2.1|0.3352
73813446|NCT01438814|147176199|SUPERIORITY_OR_OTHER|||||||0.0308|||||||Fisher Exact|Fishers exact p-value presented due to small cell counts||||||0.0308
73813447|NCT01438814|147176200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0545||95.0|0.0|1.0|||ANCOVA|||||1.0|-0.0|0.0545
73813448|NCT01438814|147176201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.997||||0.9886||95.0|0.689|1.445|||Regression, Logistic|||||1.445|0.689|0.9886
73813449|NCT01438814|147176202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.797||||0.2108||95.0|0.558|1.137|||Regression, Logistic|||||1.137|0.558|0.2108
73813450|NCT01438814|147176203|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.9972||95.0|0.712|1.402|||Regression, Logistic|||||1.402|0.712|0.9972
73813451|NCT01438814|147176204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.832||||0.2816||95.0|0.594|1.163|||Regression, Logistic|||||1.163|0.594|0.2816
73813452|NCT01438814|147176205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.19||0.0011||95.0|0.25|0.98|||ANCOVA|||||0.98|0.25|0.0011
73813453|NCT01438814|147176206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.951||||0.7682||95.0|0.681|1.328|||Regression, Logistic|||||1.328|0.681|0.7682
73813454|NCT00336323|147176208|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 1.25 mg injection at baseline and at 6 weeks treatment group||||0.009
73813455|NCT00336323|147176208|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 2.5mg injection at baseline and 6 weeks treatment group||||<0.001
73813456|NCT00336323|147176208|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit||||0.66
73813457|NCT00336323|147176208|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit||||0.49
73813458|NCT00336323|147176208|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit||||0.45
73813459|NCT00336323|147176208|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit||||0.90
73813460|NCT00336323|147176209|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit||||0.42
73813461|NCT00336323|147176209|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit||||0.67
73813462|NCT00336323|147176209|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit||||0.48
73813463|NCT00336323|147176209|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Least squares regression|||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit||||0.82
73813464|NCT00336323|147176209|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 1.25mg injection at baseline and at 6 weeks treatment group||||0.01
73813465|NCT00336323|147176209|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 2.5mg injection at baseline and at 6 weeks treatment group||||0.003
73813466|NCT00336323|147176212|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline central subfield thickness of \<400 microns compared to those that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.||||<0.0001
73813467|NCT00336323|147176213|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Least squares regression|Adjusted for baseline score||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline visual acuity letter score that was \<65 letters compared to those that had baseline visual acuity letter score that was ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.||||0.31
73813468|NCT00336323|147176214|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between those that were ≤66 years old compared to those that were \>66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.44
73813469|NCT00336323|147176215|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.||||0.55
73813470|NCT00336323|147176216|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had no history of treatment for diabetic macular edema compared to those that had history or treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.||||0.16
73813471|NCT00336323|147176217|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline retinopathy severity that was \<severe nonproliferative diabetic retinopathy (NPDR) compared to those that had baseline retinopathy severity that was proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.||||0.53
73813472|NCT00336323|147176218|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline clinical diabetic macular edema characterized as typical/predominantly focal, neither predominantly focal or diffuse, or typical/predominantly diffuse. Eyes included all of those from the pooled Bevacizumab group.||||0.93
73813473|NCT00336323|147176219|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline subretinal fluid that was definite/questionable compared to eyes that had no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.52
73813474|NCT00336323|147176220|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had baseline central subfield thickness of \<400 microns compared to eyes that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.||||0.22
73813475|NCT00336323|147176221|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline visual acuity letter score of \<65 letters compared to eyes that had baseline visual acuity letter score of ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.||||0.006
73813476|NCT00336323|147176222|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that were ≤66 years old at baseline compared to eyes that were \>66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.23
73813477|NCT00336323|147176223|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.||||0.37
73813478|NCT00336323|147176224|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that did not have a prior history of treatment for diabetic macular edema compared to eyes that did have a prior history of treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.||||0.04
73813479|NCT00336323|147176225|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline retinopathy severity of \<severe nonproliferative diabetic retinopathy (NPDR) compared to eyes that had baseline retinopathy severity of proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.||||0.38
73813480|NCT00336323|147176226|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline clinical diabetic macular edema (DME) characterization of typical/predominantly focal compared to neither predominantly focal or diffuse characterization at baseline and compared to typical/predominantly diffuse characterization at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.45
73813481|NCT00336323|147176227|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline subretinal fluid presence that was definite/questionable compared to eyes that there was no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.06
73813482|NCT00672841|147176243|SUPERIORITY_OR_OTHER||Sensitivity|100.0||||||95.0|||||Sensitivity %||Sensitivity \[1\] = (True positives \[n=6\]/ True positives + False negatives \[n=6\])|Clinical sensitivity of the BDG test was calculated for both study groups combined||||
73813483|NCT00672841|147176243|SUPERIORITY_OR_OTHER||Specificity|50.0||||||95.0|||||% Specificity||Specificity \[0.50\]= True negatives \[n=28\]/ True negatives + False positives \[56\])|Clinical specificity of the BDG test was calculated for the study groups combined||||
73813484|NCT00672841|147176245|SUPERIORITY_OR_OTHER||Percent Sensitivity|100.0||||||95.0|||||Sensitivity||Sensitivity = (true positives \[n=6\]/true positives + false negative \[n=6\])|The clinic sensitivity of the BDG test was calculated for both study groups combined||||
73813485|NCT00672841|147176245|SUPERIORITY_OR_OTHER||Percent Specificity|52.0||||||95.0|||||Specificity||Specificity \[0.52\]= (True negatives \[n=30\]/True negatives + false positives \[n=58\])|The clinical specificity of the BDG test was calculated for both study groups combined||||
73813486|NCT03578146|147176247|SUPERIORITY||Least Squares Means (Difference)|-73.14||||0.0121|TWO_SIDED||||||ANCOVA|||||||0.0121
73813487|NCT03578146|147176247|SUPERIORITY||Least Squares Means (Difference)|-153.99|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813488|NCT03578146|147176247|SUPERIORITY||Least Squares Means (Difference)|-189.57|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813489|NCT03578146|147176247|SUPERIORITY||Least Squares Means (Difference)|-239.3|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813490|NCT03578146|147176247|SUPERIORITY||Least Squares Means (Difference)|-231.12|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813491|NCT03578146|147176248|SUPERIORITY||Least Squares Means (Difference)|52837.94|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813492|NCT03578146|147176248|SUPERIORITY||Least Squares Means (Difference)|110388.3|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813493|NCT03578146|147176248|SUPERIORITY||Least Squares Means (Difference)|163880.7|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813494|NCT03578146|147176248|SUPERIORITY||Least Squares Means (Difference)|263236.5|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813495|NCT03578146|147176248|SUPERIORITY||Least Squares Means (Difference)|270297.2|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813496|NCT03578146|147176249|SUPERIORITY||Least Squares Means (Difference)|-9.91||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
73813497|NCT03578146|147176249|SUPERIORITY||Least Squares Means (Difference)|-15.06|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813498|NCT03578146|147176249|SUPERIORITY||Least Squares Means (Difference)|-17.53|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813499|NCT03578146|147176249|SUPERIORITY||Least Squares Means (Difference)|-17.05|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813500|NCT03578146|147176249|SUPERIORITY||Least Squares Means (Difference)|-19.33|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73813501|NCT05727306|147176295|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|1.25|1.46|||||Calculated as the odds of having a depressive episode in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.46|1.25|
73813502|NCT05727306|147176296|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.32|1.58|||||Calculated as the odds of having recurrent depressive disorder in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.58|1.32|
73813503|NCT05727306|147176297|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.3|1.51|||||Calculated as the odds of having anxiety in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.51|1.30|
73813504|NCT05727306|147176298|OTHER||Incidence rate ratio (IRR)|1.42|||||TWO_SIDED|95.0|1.37|1.46|||||Calculated as the incidence rate of attending primary care in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Incidence rate ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.46|1.37|
73813505|NCT05727306|147176299|OTHER||Hazard Ratio (HR)|8.26|||||TWO_SIDED|95.0|7.55|9.04|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||9.04|7.55|
73813506|NCT05727306|147176300|OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|1.17|1.57|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.57|1.17|
73813507|NCT05727306|147176301|OTHER||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|1.14|1.87|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.87|1.14|
73813508|NCT05727306|147176302|OTHER||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|1.38|1.61|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.61|1.38|
73813509|NCT04877535|147176330|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.524|TWO_SIDED|95.0|-0.24|0.12|||t-test, 2 sided|||||0.12|-0.24|0.524
73813510|NCT04877535|147176330|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.403|TWO_SIDED|95.0|-0.4|0.16|||t-test, 2 sided|||||0.16|-0.4|0.403
73813511|NCT04877535|147176331|SUPERIORITY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.47|2.38|||Fisher Exact|||||2.38|0.47|1.00
73813512|NCT04877535|147176332|SUPERIORITY||Odds Ratio (OR)|4.3|||<|0.001|TWO_SIDED|95.0|1.81|11.13|||Fisher Exact|||||11.13|1.81|<0.001
73813513|NCT04877535|147176332|SUPERIORITY||Odds Ratio (OR)|1.08||||1|TWO_SIDED|95.0|0.23|4.19|||Fisher Exact|||||4.19|0.23|1.00
73813514|NCT04877535|147176333|SUPERIORITY||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|1.94|39.25|||Fisher Exact|||||39.25|1.94|<0.001
73813515|NCT04877535|147176333|SUPERIORITY||Odds Ratio (OR)|1.63||||0.63|TWO_SIDED|95.0|0.13|14.86|||Fisher Exact|||||14.86|0.13|0.630
73813516|NCT00824382|147176342|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.091|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.051|0.131|||ANCOVA|||Olodaterol 2mcg - Placebo||0.131|0.051|<0.0001
73813517|NCT00824382|147176342|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.132|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.091|0.172|||ANCOVA|||Olodaterol 5mcg - Placebo||0.172|0.091|<0.0001
73813518|NCT00824382|147176342|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.132|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.092|0.172|||ANCOVA|||Olodaterol 10mcg - Placebo||0.172|0.092|<0.0001
73813519|NCT00824382|147176343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.021||0.0002||95.0|0.039|0.124|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.124|0.039|0.0002
73813520|NCT00824382|147176343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.184|0.098|<0.0001
73813521|NCT00824382|147176343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.115|0.199|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.199|0.115|<0.0001
73813522|NCT00824382|147176344|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.138|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.095|0.182|||ANCOVA|||Olodaterol 2mcg - Placebo||0.182|0.095|<0.0001
73896360|NCT00412373|147326174|SUPERIORITY_OR_OTHER||LS Means Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.5||0.001||95.0|-7.7|-2.0|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-2.0|-7.7|0.001
73813523|NCT00824382|147176344|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.197|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.154|0.241|||ANCOVA|||Olodaterol 5mcg - Placebo||0.241|0.154|<0.0001
73813524|NCT00824382|147176344|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.193|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.15|0.236|||ANCOVA|||Olodaterol 10mcg - Placebo||0.236|0.150|<0.0001
73813525|NCT00824382|147176345|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.146|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.101|0.191|||ANCOVA|||Olodaterol 2mcg - Placebo||0.191|0.101|<0.0001
73813526|NCT00824382|147176345|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.202|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.157|0.247|||ANCOVA|||Olodaterol 5mcg - Placebo||0.247|0.157|<0.0001
73813527|NCT00824382|147176345|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.196|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.151|0.24|||ANCOVA|||Olodaterol 10mcg - Placebo||0.240|0.151|<0.0001
73813528|NCT00824382|147176346|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.191|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001||95.0|0.107|0.275|||ANCOVA|||Olodaterol 2mcg - Placebo||0.275|0.107|<0.0001
73896361|NCT02871882|147326175|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
73813529|NCT00824382|147176346|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.191|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001||95.0|0.106|0.276|||ANCOVA|||Olodaterol 5mcg - Placebo||0.276|0.106|<0.0001
73813530|NCT00824382|147176346|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.187|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001||95.0|0.103|0.27|||ANCOVA|||Olodaterol 10mcg - Placebo||0.270|0.103|<0.0001
73813531|NCT00824382|147176347|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.253|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.16|0.345|||ANCOVA|||Olodaterol 2mcg - Placebo||0.345|0.160|<0.0001
73813532|NCT00824382|147176347|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.25|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.156|0.343|||ANCOVA|||Olodaterol 5mcg - Placebo||0.343|0.156|<0.0001
73813533|NCT00824382|147176347|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.233|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.141|0.325|||ANCOVA|||Olodaterol 10mcg - Placebo||0.325|0.141|<0.0001
73813534|NCT00824382|147176348|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.253|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.155|0.351|||ANCOVA|||Olodaterol 2mcg - Placebo||0.351|0.155|<0.0001
73813535|NCT00824382|147176348|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.242|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.142|0.341|||ANCOVA|||Olodaterol 5mcg - Placebo||0.341|0.142|<0.0001
73813536|NCT00824382|147176348|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.226|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.129|0.324|||ANCOVA|||Olodaterol 10mcg - Placebo||0.324|0.129|<0.0001
73813537|NCT00824382|147176349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.039||0.0045||95.0|0.035|0.188|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.188|0.035|0.0045
73813538|NCT00824382|147176349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.14|0.293|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.293|0.140|<0.0001
73813539|NCT00824382|147176349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.142|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.292|0.142|<0.0001
73813540|NCT00824382|147176350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.039||0.0348||95.0|0.006|0.159|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.159|0.006|0.0348
73813541|NCT00824382|147176350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.1|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.252|0.100|<0.0001
73813542|NCT00824382|147176350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.115|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.265|0.115|<0.0001
73813543|NCT00824382|147176351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.256|STANDARD_ERROR_OF_MEAN|5.476|<|0.0001||95.0|16.477|38.036|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||38.036|16.477|<0.0001
73813544|NCT00824382|147176351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.383|STANDARD_ERROR_OF_MEAN|5.574|<|0.0001||95.0|18.41|40.357|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||40.357|18.410|<0.0001
73813545|NCT00824382|147176351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.678|STANDARD_ERROR_OF_MEAN|5.431|<|0.0001||95.0|25.987|47.369|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||47.369|25.987|<0.0001
73813546|NCT00824382|147176352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.052|STANDARD_ERROR_OF_MEAN|5.534|<|0.0001||95.0|18.159|39.946|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||39.946|18.159|<0.0001
73813547|NCT00824382|147176352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.955|STANDARD_ERROR_OF_MEAN|5.635|<|0.0001||95.0|19.861|42.049|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||42.049|19.861|<0.0001
73813548|NCT00824382|147176352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.191|STANDARD_ERROR_OF_MEAN|5.489|<|0.0001||95.0|26.386|47.996|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||47.996|26.386|<0.0001
73813549|NCT00824382|147176353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.191|STANDARD_ERROR_OF_MEAN|0.149||0.2016||95.0|-0.485|0.103|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.103|-0.485|0.2016
73813550|NCT00824382|147176353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.454|STANDARD_ERROR_OF_MEAN|0.151||0.0029||95.0|-0.752|-0.156|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||-0.156|-0.752|0.0029
73813551|NCT00824382|147176353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387|STANDARD_ERROR_OF_MEAN|0.148||0.0095||95.0|-0.678|-0.095|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.095|-0.678|0.0095
73813552|NCT02407054|147176368|SUPERIORITY||Hazard Ratio (HR)|0.5871|||||TWO_SIDED|95.0|0.3967|0.869||||||||0.8690|0.3967|
73813553|NCT02407054|147176369|SUPERIORITY||Hazard Ratio (HR)|0.6515|||||TWO_SIDED|95.0|0.4123|1.0294||||||||1.0294|0.4123|
73813554|NCT02044874|147176380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.0027|TWO_SIDED|95.0|1.47|6.22|||Regression, Logistic|||||6.22|1.47|0.0027
73813555|NCT02044874|147176380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.2427|TWO_SIDED|95.0|0.73|3.51|||Regression, Logistic|||||3.51|0.73|0.2427
73813556|NCT02044874|147176380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0477|TWO_SIDED|95.0|1.01|3.56|||Regression, Logistic|||||3.56|1.01|0.0477
73813557|NCT02044874|147176381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0784|TWO_SIDED|95.0|0.89|9.08|||Regression, Logistic|||||9.08|0.89|0.0784
73813558|NCT02044874|147176381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.365|TWO_SIDED|95.0|0.51|6.17|||Regression, Logistic|||||6.17|0.51|0.3650
73813559|NCT02044874|147176381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.3438|TWO_SIDED|95.0|0.61|4.21|||Regression, Logistic|||||4.21|0.61|0.3438
73813560|NCT02044874|147176382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0379|TWO_SIDED|95.0|1.04|3.55|||Regression, Logistic|||||3.55|1.04|0.0379
73813561|NCT02044874|147176382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8628|TWO_SIDED|95.0|0.54|2.09|||Regression, Logistic|||||2.09|0.54|0.8628
73813562|NCT02044874|147176382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0556|TWO_SIDED|95.0|0.99|3.31|||Regression, Logistic|||||3.31|0.99|0.0556
73813563|NCT02044874|147176383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0219|TWO_SIDED|95.0|1.1|3.35|||Regression, Logistic|||||3.35|1.10|0.0219
73813564|NCT02044874|147176383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.545|TWO_SIDED|95.0|0.66|2.18|||Regression, Logistic|||||2.18|0.66|0.5450
73813565|NCT02044874|147176383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.0868|TWO_SIDED|95.0|0.93|2.72|||Regression, Logistic|||||2.72|0.93|0.0868
73813566|NCT02044874|147176384|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.97||||0.0004|TWO_SIDED|95.0|-1.51|-0.43|||Mixed-effects repeated measures|||||-0.43|-1.51|0.0004
73813567|NCT02044874|147176384|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.34||||0.2268|TWO_SIDED|95.0|-0.89|0.21|||mixed effects repeated measures|||||0.21|-0.89|0.2268
73813568|NCT02044874|147176384|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.63||||0.0217|TWO_SIDED|95.0|-1.17|-0.09|||mixed effects repeated measures|||||-0.09|-1.17|0.0217
73813569|NCT00415597|147176386|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0||||<0.0001
73813570|NCT00415597|147176387|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0||||<0.0001
73813571|NCT01447927|147176388|SUPERIORITY_OR_OTHER|||||||0.7981|||||||Wilcoxon Rank-Rum Test (1-sided)|||The null hypothesis was that the percent change in mean pS6K1 values (from pre to post) was the same or increased for the metformin arm as compared to placebo. Assuming equal standard deviations (i.e. 50%) across the metformin and placebo groups, 30 participants per arm yielded 84% power to detect at least a 35% decrease in the metformin arm as compared to placebo, using a 1-sided t-test with a significant level of 0.05.||||0.7981
73813572|NCT01650545|147176408|SUPERIORITY|||||||0.03|||||||Log Rank|||||||0.03
73813573|NCT04643964|147176474|SUPERIORITY|||||||0.54|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. No covariates were included.||||.54
73813574|NCT04643964|147176475|SUPERIORITY|||||||0.92|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There was one covariate in this model: QIDS at Time 1.||||.92
73813575|NCT04643964|147176476|SUPERIORITY|||||||0.37|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There were three covariates in this model: QIDS at Time 1, gender, and COVID interference.||||.37
73813576|NCT04643964|147176477|SUPERIORITY|||||||0.87|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There was one covariate in this model: QIDS at Time 1.||||.87
73813577|NCT01472939|147176501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.06||||0.128|TWO_SIDED|95.0|-1.743|13.862|||Mixed Models Repeated Measures Analysis|||||13.862|-1.743|0.128
73813578|NCT01472939|147176501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.42||||0.062|TWO_SIDED|95.0|-0.378|15.212|||Mixed Models Repeated Measures Analysis|||||15.212|-0.378|0.062
73813579|NCT01472939|147176501|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83||||0.65|TWO_SIDED|95.0|-6.1|9.765|||Mixed Models Repeated Measures Analysis|||||9.765|-6.100|0.650
73813580|NCT01472939|147176502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.75||||0.102|TWO_SIDED|95.0|-1.344|14.85|||Mixed Models Repeated Measures Analysis|||||14.850|-1.344|0.102
73813581|NCT01472939|147176502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.92||||0.031|TWO_SIDED|95.0|0.814|17.021|||Mixed Models Repeated Measures Analysis|||||17.021|0.814|0.031
73813582|NCT01472939|147176502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.71||||0.175|TWO_SIDED|95.0|-2.54|13.957|||Mixed Models Repeated Measures Analysis|||||13.957|-2.540|0.175
73813583|NCT01472939|147176503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.47||||0.064|TWO_SIDED|95.0|-5.087|0.141|||Mixed Models Repeated Measures Analysis|||||0.141|-5.087|0.064
73813584|NCT01472939|147176503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.017|TWO_SIDED|95.0|-5.818|-0.573|||Mixed Models Repeated Measures Analysis|||||-0.573|-5.818|0.017
73813585|NCT01472939|147176503|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.15||||0.114|TWO_SIDED|95.0|-4.813|0.519|||Mixed Models Repeated Measures Analysis|||||0.519|-4.813|0.114
73813586|NCT00388297|147176525|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate|0.0||||0.71|TWO_SIDED|95.0|-3.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-3|0.71
73813587|NCT00388297|147176525|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate|-1.0||||0.3|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-4|0.30
73813588|NCT00388297|147176526|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
73813589|NCT00388297|147176526|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
73813590|NCT00388297|147176527|SUPERIORITY_OR_OTHER|||||||0.81|||||||Chi-squared|||Analysis for \< 34 weeks||||0.81
73813591|NCT00388297|147176527|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||Analysis for \<34 weeks||||0.47
73813592|NCT00388297|147176527|SUPERIORITY_OR_OTHER|||||||0.44|||||||Chi-squared|||Analysis for \<37 weeks||||0.44
73813593|NCT00388297|147176527|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||Analysis for \< 37 weeks||||0.11
73813594|NCT00388297|147176527|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.31|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (24 months)||3|0|0.31
73813595|NCT00388297|147176527|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.3|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-II Language (24 months)||3|0|0.30
73813596|NCT00388297|147176527|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.89|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (12 months)||0|0|0.89
73813597|NCT00388297|147176527|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.54|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (12 months)||3|0|0.54
73813598|NCT00388297|147176527|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.92|TWO_SIDED|95.0|-3.0|3.0|||Chi-squared|||Bayley-III Language (12 months)||3|-3|0.92
73813599|NCT00388297|147176527|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.7|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)||0|0|0.70
73813600|NCT00388297|147176527|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.2|TWO_SIDED|95.0|-3.0|0.0|||Chi-squared|||Bayley-III Motor (24 months)||0|-3|0.20
73813601|NCT00388297|147176527|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.71|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||Bayley-II Language (24 months)||2|-3|0.71
73813602|NCT00388297|147176528|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.89|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.89
73813603|NCT00388297|147176528|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.48|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.48
73813604|NCT00388297|147176529|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.9|TWO_SIDED|95.0|-2.0|3.0|||Chi-squared|||||3|-2|0.90
73813605|NCT00388297|147176529|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.64|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.64
73813606|NCT00388297|147176530|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.6|TWO_SIDED|95.0|-5.0|7.0|||Chi-squared|||Analysis for recall of digits forward||7|-5|0.60
73813607|NCT00388297|147176530|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.22|TWO_SIDED|95.0|-8.0|0.0|||Chi-squared|||Analysis for recall of digits forward||0|-8|0.22
73813608|NCT00388297|147176530|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.52|TWO_SIDED|95.0|-6.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures||0|-6|0.52
73813609|NCT00388297|147176530|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.91|TWO_SIDED|95.0|-4.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures||0|-4|0.91
73813610|NCT00388297|147176531|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.63|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley II Cognitive (12 months)||0|0|0.63
73813611|NCT00388297|147176531|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.83|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley II Motor (12 mo)||3|0|0.83
73813612|NCT00388297|147176531|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.48|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Language (12 months)||3|0|0.48
73813613|NCT00388297|147176531|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.59|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)||0|0|0.59
73813614|NCT00388297|147176532|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.99|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months||2|-2|0.99
73813615|NCT00388297|147176532|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.96|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 60 months||2|-2|0.96
73813616|NCT00388297|147176532|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.65|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months||2|-2|0.65
73813617|NCT00388297|147176532|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.44|TWO_SIDED|95.0|-3.0|1.0|||Chi-squared|||CBCL at 60 months||1|-3|0.44
73813618|NCT00388297|147176533|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.37|TWO_SIDED|95.0|-1.0|2.0|||Chi-squared|||||2|-1|0.37
73813619|NCT00388297|147176533|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.98|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||||2|-2|0.98
73813620|NCT00388297|147176534|SUPERIORITY_OR_OTHER|||||||0.12|||||||Chi-squared|||||||0.12
73813621|NCT00388297|147176534|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
73813622|NCT00388297|147176535|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||||||0.69
73813623|NCT00388297|147176535|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
73813624|NCT00388297|147176536|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||||||0.76
73813625|NCT00388297|147176536|SUPERIORITY_OR_OTHER|||||||0.64|||||||Chi-squared|||||||0.64
73813626|NCT00388297|147176537|SUPERIORITY_OR_OTHER|||||||0.66|||||||Chi-squared|||||||0.66
73813627|NCT00388297|147176537|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
73813628|NCT00388297|147176538|SUPERIORITY_OR_OTHER|||||||0.24|||||||Chi-squared|||||||0.24
73813629|NCT00388297|147176538|SUPERIORITY_OR_OTHER|||||||0.55|||||||Chi-squared|||||||0.55
73813630|NCT00388297|147176539|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.36
73813631|NCT00388297|147176539|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||||||0.28
73813632|NCT00388297|147176540|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.50
73813633|NCT00388297|147176540|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
73813634|NCT00388297|147176541|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Apgar at 1 min \< 4||||0.76
73813635|NCT00388297|147176541|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Apgar \> 4 at 1 minute||||0.76
73813636|NCT00388297|147176541|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||Apgar \< 7 at 5 minutes||||0.69
73813637|NCT00388297|147176541|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||Apgar \< 7 at 5 minutes||||0.45
73813638|NCT00388297|147176542|SUPERIORITY_OR_OTHER|||||||0.24|||||||Chi-squared|||||||0.24
73813639|NCT00388297|147176542|SUPERIORITY_OR_OTHER|||||||0.97|||||||Chi-squared|||||||0.97
73813640|NCT00388297|147176543|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
73813641|NCT00388297|147176543|SUPERIORITY_OR_OTHER|||||||0.68|||||||Chi-squared|||||||0.68
73813642|NCT00388297|147176544|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
73813643|NCT00388297|147176544|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
73813644|NCT00388297|147176545|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
73813645|NCT00388297|147176545|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared|||||||0.75
73813646|NCT00388297|147176546|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
73813647|NCT00388297|147176547|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
73813648|NCT00388297|147176547|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
73813649|NCT00388297|147176548|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
73896362|NCT00797966|147326190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.6551|TWO_SIDED|95.0|-2.87|1.81|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||1.81|-2.87|0.6551
73813650|NCT00388297|147176548|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||0.49
73813651|NCT00388297|147176549|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||||||0.99
73813652|NCT00388297|147176549|SUPERIORITY_OR_OTHER|||||||0.85|||||||Chi-squared|||||||0.85
73813653|NCT00388297|147176550|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
73813654|NCT00388297|147176550|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
73813655|NCT02607280|147176551|OTHER||LS mean change from baseline at Week 14|-1.79|||||TWO_SIDED|95.0|-2.45|-1.14||||||||-1.14|-2.45|
73813656|NCT02607280|147176551|OTHER||LS mean change from baseline at Week 14|-2.07|||||TWO_SIDED|95.0|-3.77|-0.36||||||||-0.36|-3.77|
73813657|NCT04526574|147176710|NON_INFERIORITY|Noninferiority (NI) for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|Geometric Mean Ratio (GMR)|0.74|||||TWO_SIDED|95.0|0.65|0.84||||||Serotype 1: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of least square (LS) means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.84|0.65|
73813658|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.82|||||TWO_SIDED|95.0|0.75|0.9||||||Serotype 3: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.90|0.75|
73813659|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||Serotype 4: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.02|0.77|
73813660|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||Serotype 5: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.98|0.79|
73813661|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.76|||||TWO_SIDED|95.0|0.65|0.88||||||Serotype 6A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.88|0.65|
73813662|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.81|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 6B: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.94|0.71|
73813663|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.9|||||TWO_SIDED|95.0|0.83|0.99||||||Serotype 7F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.99|0.83|
73813664|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.8|||||TWO_SIDED|95.0|0.7|0.93||||||Serotype 8: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.93|0.70|
73813665|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.94|||||TWO_SIDED|95.0|0.82|1.07||||||Serotype 9V: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.07|0.82|
73813666|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.83|||||TWO_SIDED|95.0|0.71|0.96||||||Serotype 10A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.96|0.71|
73813667|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.71|||||TWO_SIDED|95.0|0.6|0.84||||||Serotype 11A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.84|0.60|
73813668|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.82|||||TWO_SIDED|95.0|0.69|0.97||||||Serotype 12F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.97|0.69|
73813669|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.86|||||TWO_SIDED|95.0|0.76|0.96||||||Serotype 14: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.96|0.76|
73813670|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.7|||||TWO_SIDED|95.0|0.57|0.86||||||Serotype 15B: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.86|0.57|
73813671|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.9|||||TWO_SIDED|95.0|0.77|1.04||||||Serotype 18C: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.04|0.77|
73813672|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.88|||||TWO_SIDED|95.0|0.78|0.98||||||Serotype 19A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.98|0.78|
73813673|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.89|||||TWO_SIDED|95.0|0.78|1.01||||||Serotype 19F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.01|0.78|
73813674|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.75|||||TWO_SIDED|95.0|0.62|0.9||||||Serotype 22F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.90|0.62|
73813675|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.78|||||TWO_SIDED|95.0|0.66|0.92||||||Serotype 23F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.92|0.66|
73813676|NCT04526574|147176710|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 33F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.83|0.62|
73813677|NCT04526574|147176711|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|1.07|||||TWO_SIDED|95.0|0.97|1.17||||||A/H1N1: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.17|0.97|
73813678|NCT04526574|147176711|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|0.98|||||TWO_SIDED|95.0|0.89|1.08||||||A/H3N2: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.08|0.89|
73813679|NCT04526574|147176711|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|1.0|||||TWO_SIDED|95.0|0.93|1.08||||||B/Victoria: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.08|0.93|
73813680|NCT04526574|147176711|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|0.95|||||TWO_SIDED|95.0|0.87|1.03||||||B/Phuket: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.03|0.87|
73813681|NCT02248974|147176720|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline Knowledge Scale score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.||||0.01
73813682|NCT02248974|147176721|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline KS score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.||||0.47
73813683|NCT02248974|147176722|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.||||0.12
73813684|NCT02248974|147176723|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.||||0.79
73813685|NCT02248974|147176724|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
73813686|NCT02248974|147176725|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
73813687|NCT02248974|147176726|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
73813688|NCT02248974|147176727|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
73813689|NCT02248974|147176728|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
73896363|NCT00797966|147326190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.7037|TWO_SIDED|95.0|-2.3|1.55|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||1.55|-2.30|0.7037
73813690|NCT02248974|147176729|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
73813691|NCT02248974|147176730|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
73813692|NCT02248974|147176732|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
73813693|NCT02248974|147176733|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
73813694|NCT02248974|147176737|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
73813695|NCT02248974|147176738|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
73813696|NCT02248974|147176739|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
73813697|NCT02248974|147176740|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
73813698|NCT02248974|147176741|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73813699|NCT02248974|147176742|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
73813700|NCT02248974|147176744|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
73813701|NCT02248974|147176745|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
73813702|NCT02248974|147176746|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
73813703|NCT02248974|147176753|SUPERIORITY|||||||0.98|||||||Fisher Exact|||||||0.98
73813704|NCT02248974|147176754|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
73813705|NCT02332239|147176755|SUPERIORITY||Mean Difference (Final Values)|-7.48|STANDARD_ERROR_OF_MEAN|4.11||0.07|TWO_SIDED||||||Mixed effects longitudinal regression||d=0.37|BDI Score where baseline \>=20: 8 week||||0.07
73813706|NCT02332239|147176756|SUPERIORITY||Median Difference (Final Values)|-7.29|STANDARD_ERROR_OF_MEAN|2.62||0.01|TWO_SIDED||||||quantile regression models|Controlled for baseline and gender|d=0.46|CTS Score where baseline \>=4: 8 week||||0.01
73813707|NCT02332239|147176759|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
73813708|NCT00396877|147176762|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|11.1||||0.434|TWO_SIDED|95.0|-19.2|33.6||The a-priori threshold for statistical significance was \< 0.035 reflecting the adjustment for interim analyses. No other adjustment for multiplicity was made.|Log Rank|A two-sided log-rank test was used.|The Relative Risk Reduction (Clopidogrel versus placebo) and its corresponding 95% confidence interval were estimated using Cox's proportional hazards model.|"Due to the limited knowledge in this population, 3 interim analyses were performed at approximatively 40%, 60%, 80% and 100% of of the maximum number of 172 required primary efficacy events to evaluate the effect of Clopidogrel on the primary endpoint with the potential to end the trial in case of a clear efficacy advantage for Clopidogrel.~The study was designed with 80% power and an overall type I error rate of 5%."||33.6|-19.2|0.4340
73813709|NCT00334802|147176765|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value for Dose Level 1 Responders (Complete Response + Partial Response)|t-test, 2 sided|||||||0.169
73813710|NCT00334802|147176765|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Dose Level 2 Responders (Complete Response + Partial Response)|t-test, 2 sided|||||||0.001
73813711|NCT03436199|147176772|SUPERIORITY||Risk Difference (RD)|0.064||||0.0811|TWO_SIDED|95.0|-0.008|0.136|||Farrington-Manning score test|The Miettinen-Nurminen method was used to obtain the 95% confidence intervals.||||0.136|-0.008|0.0811
73813712|NCT03436199|147176772|SUPERIORITY||Risk Difference (RD)|0.098||||0.0104|TWO_SIDED|95.0|0.023|0.174|||Farrington-Manning score test|The Miettinen-Nurminen method was used to obtain the 95% confidence intervals.||||0.174|0.023|0.0104
73813713|NCT03436199|147176773|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.048||0.0162|TWO_SIDED|95.0|0.02|0.21|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.21|0.02|0.0162
73813714|NCT03436199|147176773|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0142|TWO_SIDED|95.0|0.02|0.22|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.22|0.02|0.0142
73813715|NCT03436199|147176774|SUPERIORITY||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.538||0.1424|TWO_SIDED|95.0|-1.85|0.27|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.27|-1.85|0.1424
73813716|NCT03436199|147176774|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.56||0.9467|TWO_SIDED|95.0|-1.14|1.06|||Mixed Models Analysis|Mixed models analysis with repeated measures||||1.06|-1.14|0.9467
73813717|NCT03436199|147176775|SUPERIORITY||Mean Difference (Net)|4.143|STANDARD_ERROR_OF_MEAN|1.7389||0.0176|TWO_SIDED|95.0|0.726|7.56|||Mixed Models Analysis|Mixed models analysis with repeated measures||||7.560|0.726|0.0176
73813718|NCT03436199|147176775|SUPERIORITY||Mean Difference (Net)|3.529|STANDARD_ERROR_OF_MEAN|1.8196||0.053|TWO_SIDED|95.0|-0.046|7.104|||Mixed Models Analysis|Mixed models analysis with repeated measures||||7.104|-0.046|0.0530
73813719|NCT01886781|147176792|NON_INFERIORITY_OR_EQUIVALENCE|To determine an effect size of 0.64 with 80% power, a sample size of 27 for each group (D-IBS, C-IBS and controls), with a type 1 error of 5% using a two sided test was sufficient. Sample size based on expected behaviour of primary outcome measure. The minimally clinically important difference based on the primary outcome measure with the instrument used was 50 points.|||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||An intention-to -treat (ITT) analysis was performed on all patients who underwent randomization (n = 81). The results of the ITT analysis are presented. Changes in Severity Score was examined using the mixed model for analysis of variance to account for missing data. This model used group (treatment vs control) \& time as factors.||||<0.05
73813720|NCT00424021|147176795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|46.93|||TWO_SIDED|95.0|-8.3|17.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||17.3|-8.3|
73813721|NCT00424021|147176796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3|STANDARD_DEVIATION|73.16|||TWO_SIDED|95.0|-30.3|9.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||9.7|-30.3|
73813722|NCT00424021|147176797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_DEVIATION|83.08|||TWO_SIDED|95.0|-27.4|18.0||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||18.0|-27.4|
73813723|NCT00424021|147176798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.9|STANDARD_DEVIATION|77.04|||TWO_SIDED|95.0|-34.9|7.1||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||7.1|-34.9|
73813724|NCT00424021|147176800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_DEVIATION|1.323|||TWO_SIDED|95.0|-0.15|0.57||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.57|-0.15|
73813725|NCT00424021|147176801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_DEVIATION|1.659|||TWO_SIDED|95.0|0.01|0.92||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.92|0.01|
73813726|NCT00424021|147176802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.888|||TWO_SIDED|95.0|-0.02|1.02||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||1.02|-0.02|
73896364|NCT00797966|147326190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14||||0.0303|TWO_SIDED|95.0|-4.08|-0.21|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||-0.21|-4.08|0.0303
73813727|NCT00424021|147176803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_DEVIATION|1.721|||TWO_SIDED|95.0|-0.01|0.93||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.93|-0.01|
73813728|NCT00424021|147176810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|19.41|||TWO_SIDED|95.0|-5.9|4.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||4.7|-5.9|
73813729|NCT00424021|147176811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.4|STANDARD_DEVIATION|25.79|||TWO_SIDED|95.0|-14.4|-0.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||-0.3|-14.4|
73813730|NCT00424021|147176812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|STANDARD_DEVIATION|25.31|||TWO_SIDED|95.0|-12.0|1.8||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||1.8|-12.0|
73813731|NCT00424021|147176813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|23.69|||TWO_SIDED|95.0|-8.4|4.6||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||4.6|-8.4|
73813732|NCT01672294|147176847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5376|||<|0.511|TWO_SIDED|95.0|-1.0776|2.1528||Between Outlook Intervention and Attention Control caregivers at 5 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.1528|-1.0776|<0.511
73813733|NCT01672294|147176847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4275||||0.6348|TWO_SIDED|95.0|-1.3505|2.2055||Between Outlook Intervention and Attention Control caregivers at 8 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.2055|-1.3505|0.6348
73813734|NCT01672294|147176848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6836||||0.5225|TWO_SIDED|95.0|-1.4278|2.795|||Mixed Models Analysis|||Comparison at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.7950|-1.4278|0.5225
73813735|NCT01672294|147176848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2764||||0.1972|TWO_SIDED|95.0|-0.6728|3.2257|||Mixed Models Analysis|||Comparison at 8 weeks. Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||3.2257|-0.6728|0.1972
73813736|NCT01672294|147176849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9358|||<|0.3332|TWO_SIDED|95.0|-0.9726|2.8443|||Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.8443|-0.9726|<0.3332
73813737|NCT01672294|147176849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6929||||0.3842|TWO_SIDED|95.0|-0.8783|2.2642||Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note - Missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks||2.2642|-0.8783|0.3842
73813738|NCT01672294|147176850|SUPERIORITY_OR_OTHER||expected change in difference in logs|0.0593||||0.8748|TWO_SIDED|95.0|-0.6784|0.797|||Standard negative binomial with offset||The expected change in the difference of the logs of expected Days in VA inpatient care or ED.|||0.797|-0.6784|0.8748
73896365|NCT00797966|147326191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.4166|TWO_SIDED|95.0|-0.43|0.18|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo|||0.18|-0.43|0.4166
73896366|NCT00797966|147326191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4193|TWO_SIDED|95.0|-0.35|0.15|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.15|-0.35|0.4193
73896367|NCT00797966|147326191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0064|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||-0.10|-0.60|0.0064
73813739|NCT01672294|147176851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01777||||0.7687|TWO_SIDED|95.0|-0.1372|0.1017||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 5 weeks|Mixed Models Analysis|||"Between Outlook Intervention caregivers and active control caregivers at 5 weeks.~Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks."||0.1017|-0.1372|0.7687
73813740|NCT01672294|147176851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.00087||||0.9863|TWO_SIDED|95.0|-0.1003|0.09861||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||0.09861|-0.1003|0.9863
73813741|NCT01672294|147176852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01166||||0.9221|TWO_SIDED|95.0|-0.2475|0.2241|||Mixed Models Analysis|||At 5 weeks - Completion subscale||0.2241|-0.2475|0.9221
73813742|NCT01672294|147176852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1154||||0.3249|TWO_SIDED|95.0|-0.3466|0.1158||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Comparison at 8 week time point Note- Missing first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 week.||0.1158|-0.3466|0.3249
73813743|NCT00926536|147176904|SUPERIORITY_OR_OTHER||Mean Difference (Net)|71.6|||<|0.001|TWO_SIDED|||||Decrease in DAP in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis|||||||<.001
73896368|NCT00797966|147326192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68||||0.449|TWO_SIDED|95.0|-2.67|6.02|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||6.02|-2.67|0.4490
73896369|NCT00797966|147326192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.7412|TWO_SIDED|95.0|-3.02|4.24|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||4.24|-3.02|0.7412
73813744|NCT00926536|147176905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|158.3||||0.017|TWO_SIDED|||||Decrease in CD in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis|||||||0.017
73813745|NCT01080391|147176920|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.57|0.834||Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes)|Log Rank|The stopping boundary for this analysis was 0.0127 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).||||0.834|0.570|< 0.0001
73813746|NCT01080391|147176921|SUPERIORITY|The stopping boundary for this analysis was 0.0231 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).|Hazard Ratio (HR)|0.794||||0.0045|TWO_SIDED|95.0|0.667|0.945|||Log Rank|Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes).||The final analysis of OS was to be performed after 510 deaths occur. A total of 510 deaths would provide 85% power to detect, with a 1-sided significance level of 0.025, a hazard ratio of 0.765 corresponding to a 23.5% reduction in risk for death for CRd versus Rd (39.2 vs. 30.0 months, respectively).||0.945|0.667|0.0045
73813747|NCT01080391|147176922|SUPERIORITY||Odds Ratio (OR)|3.472|||<|0.0001|TWO_SIDED|95.0|2.411|5.001|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.|||5.001|2.411|< 0.0001
73813748|NCT01080391|147176923|SUPERIORITY||Odds Ratio (OR)|1.897||||0.0044|TWO_SIDED|95.0|1.17|3.08|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.|||3.08|1.17|0.0044
73813749|NCT01260584|147176939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|STANDARD_ERROR_OF_MEAN|4.11||0.0624|TWO_SIDED|95.0|-0.4|15.8|||Mixed Models Analysis|||For the sample size calculations for the co-primary endpoints, no Type 1 error rate was adjusted and both co-primary endpoints will be tested at the 0.05 level.||15.8|-0.4|0.0624
73813750|NCT01260584|147176939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.8|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|95.0|25.1|38.4|||Mixed Models Analysis|||||38.4|25.1|<0.0001
73813751|NCT01260584|147176939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.08||0.244|TWO_SIDED|95.0|-3.3|12.8|||Mixed Models Analysis|||||12.8|-3.3|0.2440
73813752|NCT01260584|147176939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.7|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|28.4|41.0|||Mixed Models Analysis|||||41.0|28.4|<0.0001
73813753|NCT01260584|147176939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.0|STANDARD_ERROR_OF_MEAN|4.14|<|0.0001|TWO_SIDED|95.0|18.8|35.2|||Mixed Models Analysis|||||35.2|18.8|<0.0001
73813754|NCT01260584|147176940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.2|STANDARD_ERROR_OF_MEAN|12.65||0.0048|TWO_SIDED|95.0|-61.1|-11.2|||Mixed Models Analysis|||||-11.2|-61.1|0.0048
73813755|NCT01260584|147176940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-93.8|STANDARD_ERROR_OF_MEAN|11.54|<|0.0001|TWO_SIDED|95.0|-116.7|-71.0|||Mixed Models Analysis|||||-71.0|-116.7|<0.0001
73813756|NCT01260584|147176940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|STANDARD_ERROR_OF_MEAN|12.53||0.0924|TWO_SIDED|95.0|-45.9|3.5|||Mixed Models Analysis|||||3.5|-45.9|0.0924
73813757|NCT01260584|147176940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-108.8|STANDARD_ERROR_OF_MEAN|10.85|<|0.0001|TWO_SIDED|95.0|-130.3|-87.3|||Mixed Models Analysis|||||-87.3|-130.3|<0.0001
73813758|NCT01260584|147176940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.6|STANDARD_ERROR_OF_MEAN|12.73|<|0.0001|TWO_SIDED|95.0|-97.8|-47.5|||Mixed Models Analysis|||||-47.5|-97.8|<0.0001
73813759|NCT01260584|147176941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|3.72||0.0423|TWO_SIDED|95.0|-15.0|-0.3|||Mixed Models Analysis|||||-0.3|-15.0|0.0423
73813760|NCT01260584|147176941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-29.0|-16.4|||Mixed Models Analysis|||||-16.4|-29.0|<0.0001
73813761|NCT01260584|147176941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|3.7||0.1184|TWO_SIDED|95.0|-13.1|1.5|||Mixed Models Analysis|||||1.5|-13.1|0.1184
73813762|NCT01260584|147176941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.5|STANDARD_ERROR_OF_MEAN|3.02|<|0.0001|TWO_SIDED|95.0|-30.5|-18.5|||Mixed Models Analysis|||||-18.5|-30.5|<0.0001
73813763|NCT01260584|147176941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|3.76|<|0.0001|TWO_SIDED|95.0|-24.3|-9.5|||Mixed Models Analysis|||||-9.5|-24.3|<0.0001
73813764|NCT01260584|147176942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.1331|TWO_SIDED|95.0|0.8|5.32|||Regression, Logistic|||||5.32|0.80|0.1331
73813765|NCT01260584|147176942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.5813|TWO_SIDED|95.0|0.17|23.65|||Regression, Logistic|||||23.65|0.17|0.5813
73813766|NCT01260584|147176942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.54||||0.0127|TWO_SIDED|95.0|1.85|148.23|||Regression, Logistic|||||148.23|1.85|0.0127
73813767|NCT01260584|147176942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.11||||0.0013|TWO_SIDED|95.0|3.13|93.65|||Regression, Logistic|||||93.65|3.13|0.0013
73813768|NCT01260584|147176943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.5684|TWO_SIDED|95.0|0.49|3.67|||Regression, Logistic|||||3.67|0.49|0.5684
73813769|NCT01260584|147176943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.7||||0.0447|TWO_SIDED|95.0|1.05|42.92|||Regression, Logistic|||||42.92|1.05|0.0447
73813770|NCT01260584|147176943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|58.64||||0.0003|TWO_SIDED|95.0|6.8|505.58|||Regression, Logistic|||||505.58|6.80|0.0003
73813771|NCT01260584|147176943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.71||||0.0006|TWO_SIDED|95.0|2.95|46.52|||Regression, Logistic|||||46.52|2.95|0.0006
73813772|NCT01260584|147176944|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|110.7|||||TWO_SIDED|90.0|93.7|130.8|||Mixed Models Analysis|||Prasugrel active metabolite R-138727||130.8|93.7|
73813773|NCT01260584|147176944|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|118.4|||||TWO_SIDED|90.0|99.8|140.4|||Mixed Models Analysis|||active metabolite R-130964||140.4|99.8|
73813774|NCT01260584|147176945|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|117.9|||||TWO_SIDED|90.0|94.4|147.3|||Mixed Models Analysis||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Prasugrel active metabolite R-138727||147.3|94.4|
73813775|NCT01260584|147176945|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|123.8|||||TWO_SIDED|90.0|98.6|155.4|||Mixed Models Analysis||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Clopidogrel active metabolite R-130964||155.4|98.6|
73813776|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3375||||||P-value is for Physical Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an Analysis of Covariance (ANCOVA) for change from baseline. Covariates include: treatment and baseline value.||||||0.3375
73813777|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.516||||||P-value is for Physical Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.516
73813778|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.786||||||P-value is for Physical Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.786
73813779|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1496||||||P-value is for Physical Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1496
73813780|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8428||||||P-value is for Physical Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8428
73813781|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7345||||||P-value is for Physical Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7345
73813782|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8928||||||P-value is for Physical Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8928
73896370|NCT00797966|147326192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54||||0.407|TWO_SIDED|95.0|-2.1|5.17|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||5.17|-2.10|0.4070
73896371|NCT00797966|147326193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.4954|TWO_SIDED|95.0|-0.86|0.42|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.42|-0.86|0.4954
73896372|NCT00797966|147326193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4902|TWO_SIDED|95.0|-0.73|0.35|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.35|-0.73|0.4902
73813783|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7343||||||P-value is for Physical Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7343
73813784|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8798||||||P-value is for Social/Family Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8798
73813785|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6837||||||P-value is for Social/Family Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.6837
73813786|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7226||||||P-value is for Social/Family Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7226
73813787|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641||||||P-value is for Social/Family Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.641
73813788|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.478||||||P-value is for Social/Family Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.478
73813789|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367||||||P-value is for Social/Family Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.9367
73813790|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5108||||||P-value is for Social/Family Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.5108
73813791|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8976||||||P-value is for Social/Family Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8976
73813792|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8193||||||P-value is for Emotional Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8193
73813793|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1695||||||P-value is for Emotional Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1695
73813794|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4021||||||P-value is for Emotional Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.4021
73896373|NCT00797966|147326193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0161|TWO_SIDED|95.0|-1.2|-0.12|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||-0.12|-1.20|0.0161
73896374|NCT00797966|147326199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.5953|TWO_SIDED|95.0|-2.54|1.46|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||1.46|-2.54|0.5953
73813795|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3603||||||P-value is for Emotional Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3603
73813796|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5169||||||P-value is for Emotional Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.5169
73813797|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1642||||||P-value is for Emotional Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1642
73813798|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6354||||||P-value is for Emotional Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.6354
73813799|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3517||||||P-value is for Emotional Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3517
73813800|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7605||||||P-value is for Functional Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7605
73813801|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3747||||||P-value is for Functional Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3747
73813802|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8379||||||P-value is for Functional Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8379
73813803|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1179||||||P-value is for Functional Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1179
73813804|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7412||||||P-value is for Functional Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7412
73813805|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3773||||||P-value is for Functional Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3773
73813806|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7402||||||P-value is for Functional Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7402
73813807|NCT00586508|147176975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2671||||||P-value is for Functional Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.2671
73813808|NCT00561470|147176977|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.817||||0.0032|TWO_SIDED|95.34|0.713|0.937||Stratified Log-Rank test p-value. Stratified on ECOG Performance Status and prior Bevacizumab according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.|||0.937|0.713|0.0032
73813809|NCT00561470|147176978|SUPERIORITY_OR_OTHER||Stratified Hazard ratio|0.758||||7e-05|TWO_SIDED|99.99|0.578|0.995||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model.|||0.995|0.578|0.00007
73813810|NCT00561470|147176979|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Stratified Cochran-Mantel-Haenszel|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.||||||0.0001
73813811|NCT03434249|147176982|OTHER|||||||0.0001|||||||Chi-squared|||"According to the results of a previous trial that looked at a probiotic's effect on infants with CI, it was estimated that when the sample size in each group is 33, the study has 80% power to detect an absolute difference of 35% in the treatment success rate (15% in the Placebo group and 50% in the treatment group) with a 0,05 alpha level.~The number of infants that was included in the study was 80, with an expected maximum dropout rate of 20%."||||0.0001
73813812|NCT03434249|147176983|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73813813|NCT03434249|147176985|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73813814|NCT01362244|147177118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||Fisher Exact|||Statistical data is presented for NR||||0.003
73813815|NCT01362244|147177118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0|||||Fisher Exact|||Statistical data is presented for LOCF||||0.016
73813816|NCT01362244|147177119|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74||||0.71|TWO_SIDED|95.0|0.15|3.64|||Regression, Logistic||Week 1|||3.64|0.15|0.710
73813817|NCT01362244|147177119|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.674|TWO_SIDED|95.0|0.29|6.87|||Regression, Logistic||Week 2|||6.87|0.29|0.674
73813818|NCT01362244|147177119|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.94||||0.942|TWO_SIDED|95.0|0.2|4.49|||Regression, Logistic||Week 5|||4.49|0.20|0.942
73813819|NCT01362244|147177119|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9||||0.091|TWO_SIDED|95.0|0.8|18.96|||Regression, Logistic||Week 9|||18.96|0.80|0.091
73813820|NCT01362244|147177119|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.66||||0.004|TWO_SIDED|95.0|2.18|62.33|||Regression, Logistic||Week 13|||62.33|2.18|0.004
73813821|NCT01362244|147177119|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.74||||0.224|TWO_SIDED|95.0|0.54|13.9|||Regression, Logistic||Week 17|||13.90|0.54|0.224
73813822|NCT01362244|147177119|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.85||||0.037|TWO_SIDED|95.0|1.11|30.69|||Regression, Logistic||Week 21|||30.69|1.11|0.037
73813823|NCT01362244|147177119|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.22||||0.051|TWO_SIDED|95.0|0.99|27.44|||Regression, Logistic||Week 25|||27.44|0.99|0.051
73813824|NCT01362244|147177136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.567|TWO_SIDED|95.0|-0.1|0.19|||repeated measures model||Week 2|||0.19|-0.10|0.567
73813825|NCT01362244|147177136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05||||0.495|TWO_SIDED|95.0|-0.1|0.21|||repeated measures model||Week 5|||0.21|-0.10|0.495
73813826|NCT01362244|147177136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.365|TWO_SIDED|95.0|-0.1|0.28|||repeated measures model||Week 9|||0.28|-0.10|0.365
73813827|NCT01362244|147177136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17||||0.058|TWO_SIDED|95.0|-0.01|0.34|||repeated measures model||Week 13|||0.34|-0.01|0.058
73813828|NCT01362244|147177136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.056|TWO_SIDED|95.0|-0.01|0.43|||repeated measures model||Week 17|||0.43|-0.01|0.056
73813829|NCT01362244|147177136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23||||0.028|TWO_SIDED|95.0|0.03|0.42|||repeated measures model||Week 21|||0.42|0.03|0.028
73813830|NCT01362244|147177136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16||||0.077|TWO_SIDED|95.0|-0.02|0.34|||repeated measures model||Week 25|||0.34|-0.02|0.077
73813831|NCT01362244|147177137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.486|TWO_SIDED|95.0|-0.1|0.22|||repeated measures model||Week 2|||0.22|-0.10|0.486
73813832|NCT01362244|147177137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.384|TWO_SIDED|95.0|-0.08|0.22|||repeated measures model||Week 5|||0.22|-0.08|0.384
73813833|NCT01362244|147177137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.546|TWO_SIDED|95.0|-0.14|0.26|||repeated measures model||Week 9|||0.26|-0.14|0.546
73813834|NCT01362244|147177137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.39|||repeated measures model||Week 13|||0.39|0.00|0.050
73813835|NCT01362244|147177137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22||||0.061|TWO_SIDED|95.0|-0.01|0.45|||repeated measures model||Week 17|||0.45|-0.01|0.061
73813836|NCT01362244|147177137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28||||0.016|TWO_SIDED|95.0|0.05|0.51|||repeated measures model||Week 21|||0.51|0.05|0.016
73813837|NCT01362244|147177137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18||||0.094|TWO_SIDED|95.0|-0.03|0.4|||repeated measures model||Week 25|||0.40|-0.03|0.094
73813838|NCT01362244|147177138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.11||||0.686|TWO_SIDED|95.0|-19.91|30.12|||repeated measures model||Week 2|||30.12|-19.91|0.686
73813839|NCT01362244|147177138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.55||||0.321|TWO_SIDED|95.0|-14.4|43.5|||repeated measures model||Week 5|||43.50|-14.40|0.321
73813840|NCT01362244|147177138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.91||||0.622|TWO_SIDED|95.0|-26.79|44.6|||repeated measures model||Week 9|||44.60|-26.79|0.622
73813841|NCT01362244|147177138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.24||||0.178|TWO_SIDED|95.0|-10.75|57.22|||repeated measures model||Week 13|||57.22|-10.75|0.178
73813842|NCT01362244|147177138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|38.16||||0.052|TWO_SIDED|95.0|-0.33|76.66|||repeated measures model||Week 17|||76.66|-0.33|0.052
73813843|NCT01362244|147177138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|38.72||||0.042|TWO_SIDED|95.0|1.41|76.02|||repeated measures model||Week 21|||76.02|1.41|0.042
73813844|NCT01362244|147177138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.13||||0.484|TWO_SIDED|95.0|-25.76|54.02|||repeated measures model||Week 25|||54.02|-25.76|0.484
73813845|NCT01362244|147177140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.16||||0.005|TWO_SIDED|95.0|6.49|35.83|||repeated measures model||Week 2|||35.83|6.49|0.005
73813846|NCT01362244|147177140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.89||||0.029|TWO_SIDED|95.0|1.77|32.01|||repeated measures model||Week 5|||32.01|1.77|0.029
73813847|NCT01362244|147177140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.2||||0.472|TWO_SIDED|95.0|-12.64|27.03|||repeated measures model||Week 9|||27.03|-12.64|0.472
73813848|NCT01362244|147177140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.71||||0.009|TWO_SIDED|95.0|7.19|48.23|||repeated measures model||Week 13|||48.23|7.19|0.009
73813849|NCT01362244|147177140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4||||0.114|TWO_SIDED|95.0|-3.8|34.59|||repeated measures model||Week 17|||34.59|-3.80|0.114
73813850|NCT01362244|147177140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.51||||0.014|TWO_SIDED|95.0|6.06|52.96|||repeated measures model||Week 21|||52.96|6.06|0.014
73813851|NCT01362244|147177140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.65||||0.027|TWO_SIDED|95.0|3.1|50.21|||repeated measures model||Week 25|||50.21|3.10|0.027
73813852|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.79|TWO_SIDED|95.0|-0.61|0.79|||repeated measures model||MNS, Week 2|||0.79|-0.61|0.790
73813853|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14||||0.008|TWO_SIDED|95.0|0.3|1.97|||repeated measures model||MNS, Week 5|||1.97|0.30|0.008
73813854|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79||||0.066|TWO_SIDED|95.0|-0.05|1.64|||repeated measures model||MNS, Week 9|||1.64|-0.05|0.066
73813855|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.73||||0.127|TWO_SIDED|95.0|-0.21|1.67|||repeated measures model||MNS, Week 13|||1.67|-0.21|0.127
73813856|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38||||0.481|TWO_SIDED|95.0|-0.69|1.46|||repeated measures model||MNS, Week 17|||1.46|-0.69|0.481
73813857|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65||||0.308|TWO_SIDED|95.0|-0.61|1.9|||repeated measures model||MNS, Week 21|||1.90|-0.61|0.308
73813858|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.233|TWO_SIDED|95.0|-0.46|1.88|||repeated measures model||MNS, Week 25|||1.88|-0.46|0.233
73813859|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28||||0.444|TWO_SIDED|95.0|-0.45|1.02|||repeated measures model||WNS, Week 2|||1.02|-0.45|0.444
73813860|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.31||||0.002|TWO_SIDED|95.0|0.5|2.12|||repeated measures model||WNS, Week 5|||2.12|0.50|0.002
73813861|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68||||0.143|TWO_SIDED|95.0|-0.24|1.6|||repeated measures model||WNS, Week 9|||1.60|-0.24|0.143
73813862|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62||||0.24|TWO_SIDED|95.0|-0.42|1.65|||repeated measures model||WNS, Week 13|||1.65|-0.42|0.240
73813863|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19||||0.75|TWO_SIDED|95.0|-0.98|1.35|||repeated measures model||WNS, Week 17|||1.35|-0.98|0.750
73813864|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64||||0.324|TWO_SIDED|95.0|-0.64|1.91|||repeated measures model||WNS, Week 21|||1.91|-0.64|0.324
73813865|NCT01362244|147177141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44||||0.468|TWO_SIDED|95.0|-0.77|1.66|||repeated measures model||WNS, Week 25|||1.66|-0.77|0.468
73813866|NCT01362244|147177142|SUPERIORITY_OR_OTHER_LEGACY||Mixed effects model|-13.2||||0.005|TWO_SIDED|95.0|-22.2|-4.22|||ANCOVA|||||-4.22|-22.2|0.005
73813867|NCT01362244|147177143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.07||||||||0.07|-0.06|
73813868|NCT01362244|147177144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.68|||||TWO_SIDED|95.0|-1.33|12.68||||||||12.68|-1.33|
73813869|NCT01492101|147177201|OTHER|Two-sided log-rank test, stratified by geographic region, prior use of eribulin, and receptor status.|Hazard Ratio, log|0.872|||=|0.0835|TWO_SIDED|95.0|0.747|1.019|||Log Rank|||||1.019|0.747|= 0.0835
73813870|NCT01492101|147177202|SUPERIORITY||Hazard Ratio (HR)|0.926|||=|0.3017|TWO_SIDED|95.0|0.798|1.075|||Log Rank|||||1.075|0.798|= 0.3017
73813871|NCT01492101|147177207|EQUIVALENCE|\[2\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.8||||0.635|TWO_SIDED|95.0|-2.65|4.33|||F-test|||Global health status/QoL: change from baseline to last assessment (Week 56)||4.33|-2.65|0.635
73813872|NCT01492101|147177207|EQUIVALENCE|\[3\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|2.1||||0.1656|TWO_SIDED|95.0|-0.88|5.14|||F-test|||||5.14|-0.88|0.1656
73813873|NCT01492101|147177207|EQUIVALENCE|\[4\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Median Difference (Final Values)|0.5||||0.8356|TWO_SIDED|95.0|-3.9|4.82|||F-test|||||4.82|-3.9|0.8356
73813874|NCT01492101|147177207|EQUIVALENCE|\[5\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.5||||0.7727|TWO_SIDED|95.0|-2.88|3.88|||F-test|||||3.88|-2.88|0.7727
73813875|NCT01492101|147177207|EQUIVALENCE|\[6\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.5||||0.7446|TWO_SIDED|95.0|-2.56|3.59|||F-test|||||3.59|-2.56|0.7446
73813876|NCT01492101|147177207|EQUIVALENCE|\[7\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.2||||0.9169|TWO_SIDED|95.0|-4.0|4.45|||F-test|||||4.45|-4.0|0.9169
73813877|NCT01492101|147177207|EQUIVALENCE|\[8\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.1||||0.9731|TWO_SIDED|95.0|-3.66|3.79|||F-test|||||3.79|-3.66|0.9731
73813878|NCT01492101|147177207|EQUIVALENCE|\[9\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|7.3|||<|0.0001|TWO_SIDED|95.0|3.88|10.67|||F-test|||||10.67|3.88|<0.0001
73813879|NCT01492101|147177207|EQUIVALENCE|\[10\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.1252|TWO_SIDED|95.0|-7.59|0.93|||F-test|||||0.93|-7.59|0.1252
73813880|NCT01492101|147177207|EQUIVALENCE|\[11\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.1717|TWO_SIDED|95.0|-6.83|1.22|||F-test|||||1.22|-6.83|0.1717
73813881|NCT01492101|147177207|EQUIVALENCE|\[12\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-1.4||||0.5513|TWO_SIDED|95.0|-5.95|3.18|||F-test|||||3.18|-5.95|0.5513
73813882|NCT01492101|147177207|EQUIVALENCE|\[13\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|8.6||||0.0009|TWO_SIDED|95.0|3.57|13.72|||F-test|||||13.72|3.57|0.0009
73813883|NCT01492101|147177207|EQUIVALENCE|\[14\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.2337|TWO_SIDED|95.0|-7.35|1.8|||F-test|||||1.8|-7.35|0.2337
73813884|NCT01492101|147177207|EQUIVALENCE|\[15\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|10.3|||<|0.0001|TWO_SIDED|95.0|6.6|13.98|||F-test|||||13.98|6.6|<0.0001
73813885|NCT01492101|147177207|EQUIVALENCE|\[16\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-3.74|3.69|||F-test|||||3.69|-3.74|0.99
73813886|NCT01492101|147177209|EQUIVALENCE|\[17\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.9||||0.5833|TWO_SIDED|95.0|-2.42|4.29|||F-test|||||4.29|-2.42|0.5833
73813887|NCT01492101|147177209|EQUIVALENCE|\[18\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|1.3||||0.3098|TWO_SIDED|95.0|-1.24|3.9|||F-test|||||3.9|-1.24|0.3098
73813888|NCT01492101|147177209|EQUIVALENCE|\[19\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|1.1||||0.6264|TWO_SIDED|95.0|-3.39|5.63|||F-test|||||5.63|-3.39|0.6264
73813889|NCT01492101|147177209|EQUIVALENCE|\[20\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-4.6||||0.0003|TWO_SIDED|95.0|-7.11|-2.1|||F-test|||||-2.1|-7.11|0.0003
73813890|NCT01492101|147177209|EQUIVALENCE|\[21\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-1.4||||0.2473|TWO_SIDED|95.0|-3.84|0.99|||F-test|||||0.99|-3.84|0.2473
73813891|NCT01492101|147177209|EQUIVALENCE|\[22\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.9||||0.0333|TWO_SIDED|95.0|-5.54|-0.23|||F-test|||||-0.23|-5.54|0.0333
73813892|NCT01492101|147177209|EQUIVALENCE|\[23\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-4.5||||0.2575|TWO_SIDED|95.0|-12.2|3.28|||F-test|||||3.28|-12.2|0.2575
73813893|NCT01492101|147177209|EQUIVALENCE|\[24\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|5.6||||0.1072|TWO_SIDED|95.0|-1.22|12.34|||F-test|||||12.34|-1.22|0.1072
73813894|NCT02696434|147177214|SUPERIORITY||Odds Ratio (OR)|0.68||||0.407|TWO_SIDED|95.0|0.28|1.68|||Regression, Logistic|||||1.68|0.28|0.407
73813895|NCT00316914|147177225|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||A priori threshold for the p-value is 0.05 and there was no adjustment for multiple comparisons.|Chi-squared|||Comparison in Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event between Arms||||0.038
73813896|NCT00316914|147177226|SUPERIORITY_OR_OTHER|||||||0.0503||95.0|||||Log Rank|||Comparison of time to Onset of Grade 2+ Chronic Neurotoxicity between Arms||||0.0503
73813897|NCT00316914|147177227|SUPERIORITY_OR_OTHER|||||||0.4048||95.0|||||Log Rank|||Comparison of Time to Onset of Grade 3+ Chronic Neurotoxicity between Arms||||0.4048
73813898|NCT00316914|147177228|SUPERIORITY_OR_OTHER|||||||0.6556||95.0|||||Log Rank|||Comparison of Average Duration of Chronic Neuropathic Toxicity between Arms||||0.6556
73813899|NCT00316914|147177229|SUPERIORITY_OR_OTHER|||||||0.3238||95.0|||||Chi-squared|||Comparison of Percentage of patients discontinuing therapy for chronic neurotoxicity between Arms||||0.3238
73813900|NCT00316914|147177232|SUPERIORITY_OR_OTHER|||||||0.7498||95.0|||||Chi-squared|||Comparison of Percentage of Patients With Acute Neuropathic Adverse Event between Arms||||0.7498
73813901|NCT00316914|147177235|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||Kruskal-Wallis|||Comparison of Fatigue NOW between two arms||||0.2340
73813902|NCT00316914|147177235|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||Kruskal-Wallis|||Comparison of Fatigue USUAL between two arms||||0.2010
73813903|NCT00316914|147177235|SUPERIORITY_OR_OTHER|||||||0.9364||95.0|||||Kruskal-Wallis|||Comparison of Fatigue WORST between two arms||||0.9364
73813904|NCT00316914|147177236|SUPERIORITY_OR_OTHER|||||||0.9364||95.0|||||Kruskal-Wallis|||Fatigue WORST||||0.9364
73813905|NCT00316914|147177236|SUPERIORITY_OR_OTHER|||||||0.6275||95.0|||||Kruskal-Wallis|||Walking||||0.6275
73813906|NCT00316914|147177236|SUPERIORITY_OR_OTHER|||||||0.6988||95.0|||||Kruskal-Wallis|||Buttoning Shirt or Tying Laces||||0.6988
73813907|NCT00316914|147177236|SUPERIORITY_OR_OTHER|||||||0.5124||95.0|||||Kruskal-Wallis|||Diarrhea||||0.5124
73813908|NCT00316914|147177236|SUPERIORITY_OR_OTHER|||||||0.3103||95.0|||||Kruskal-Wallis|||Constipation||||0.3103
73813909|NCT00316914|147177236|SUPERIORITY_OR_OTHER|||||||0.8601||95.0|||||Kruskal-Wallis|||Abdominal Cramping||||0.8601
73813910|NCT00316914|147177236|SUPERIORITY_OR_OTHER|||||||0.2439||95.0|||||Kruskal-Wallis|||Bowel Problems with Normal Activity||||0.2439
73813911|NCT00316914|147177236|SUPERIORITY_OR_OTHER|||||||0.9283||95.0|||||Kruskal-Wallis|||Shortness of Breath (Week 2 - Baseline)||||0.9283
73813912|NCT00316914|147177236|SUPERIORITY_OR_OTHER|||||||0.4715||95.0|||||Kruskal-Wallis|||Swallowing (Week 2 - Baseline)||||0.4715
73813913|NCT00316914|147177236|SUPERIORITY_OR_OTHER|||||||0.5105||95.0|||||Kruskal-Wallis|||Numbness in Fingers, Toes (Week 2 - Baseline)||||0.5105
73813914|NCT00316914|147177236|SUPERIORITY_OR_OTHER|||||||0.2181||95.0|||||Kruskal-Wallis|||Tingling in Fingers, Toes (Week 2 - Baseline)||||0.2181
73813915|NCT04105010|147177237|SUPERIORITY||||||<|0.0001|||||||Binomial test against a null|||||||<0.0001
73813916|NCT02380859|147177262|SUPERIORITY|||||||0.005|||||||ANOVA|||Group (real, sham) x Time (pre, 1d post) x Stepping Direction (forward, backward) ANOVA||||0.005
73813917|NCT02284568|147177276|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.1293||0.903|TWO_SIDED|95.0|-0.239|0.2705||significance at 0.05.|Repeated Measures ANCOVA|||The statistical model was a repeated measures analysis of covariance with treatment group, week, treatment group by week interaction, normalized brain volume at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||0.2705|-0.2390|0.903
73813918|NCT02284568|147177278|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.426|TWO_SIDED|95.0|0.48|1.37||significance at 0.05. p-value was from a log-rank test, and estimate and confidence limits were from a Cox model with treatment group as fixed effect, due to the violation of the proportionality assumption.|Log Rank||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or \>4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||1.37|0.48|0.426
73813919|NCT02284568|147177279|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.867|TWO_SIDED|95.0|0.68|1.59||significance at 0.05.|Regression, Cox||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or \>4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||1.59|0.68|0.867
73813920|NCT02284568|147177280|SUPERIORITY||Mean Difference (Final Values)|-0.325|STANDARD_ERROR_OF_MEAN|0.2679||0.248|TWO_SIDED|95.0|-0.85|0.2||significance at 0.05. The p-value for ranked change from baseline values was from a repeated measures analysis of covariance with trt group, week, treatment group by week interaction, rank of T25FW score at baseline, and country as fixed effects.|Repeated Measures ANCOVA||Laquinimod 0.6 mg vs. placebo treatment effect|placebo n=121 Laquinimod 0.6 mg n=108 The estimate of parameter, standard error, and 95% confidence intervals for change from baseline was from a Mann-Whitney-Wilcoxon Test using Hodges-Lehmann estimates.||0.2000|-0.8500|0.248
73813921|NCT02284568|147177281|SUPERIORITY||Risk Ratio (RR)|0.4|STANDARD_ERROR_OF_MEAN|0.11||0.001|TWO_SIDED|95.0|0.26|0.69||significance at 0.05|negative binomial regression model||Laquinimod 0.6 mg vs. placebo risk ratio|This analysis was performed using baseline adjusted negative binomial regression model (SAS® PROC GENMOD) in which 1 contrast for comparing laquinimod 0.6 mg to placebo was constructed. In addition to the treatment group, the natural logarithm of T2 lesion volume at baseline, age at baseline and country/geographical region (CGR) were used as covariates.||0.69|0.26|0.001
73813922|NCT03000530|147177388|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-10.2|-3.9|||Mixed Effect Model for Repeated Measures|The Mixed Effect Model for Repeated Measures (MMRM) included the change from baseline in HAM-D total score at each visit as the dependent variables.||||-3.9|-10.2|< 0.0001
73813923|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.99||0.0223|TWO_SIDED|95.0|-4.3|-0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 2||-0.3|-4.3|0.0223
73813924|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.18||0.001|TWO_SIDED|95.0|-6.4|-1.7|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 3||-1.7|-6.4|0.0010
73813925|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.27||0.0233|TWO_SIDED|95.0|-5.5|-0.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 4||-0.4|-5.5|0.0233
73813926|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.37||0.0066|TWO_SIDED|95.0|-6.6|-1.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 5||-1.1|-6.6|0.0066
73896375|NCT00797966|147326199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.9479|TWO_SIDED|95.0|-1.66|1.55|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||1.55|-1.66|0.9479
73813927|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.4||0.0019|TWO_SIDED|95.0|-7.3|-1.7|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 6||-1.7|-7.3|0.0019
73813928|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.53||0.0043|TWO_SIDED|95.0|-7.6|-1.5|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 7||-1.5|-7.6|0.0043
73813929|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.54||0.0318|TWO_SIDED|95.0|-6.4|-0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 8||-0.3|-6.4|0.0318
73813930|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-10.2|-3.9|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 15||-3.9|-10.2|< 0.0001
73813931|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|1.76||0.0064|TWO_SIDED|95.0|-8.4|-1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 21||-1.4|-8.4|0.0064
73813932|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.77||0.0243|TWO_SIDED|95.0|-7.6|-0.5|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 28||-0.5|-7.6|0.0243
73896376|NCT00797966|147326199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0919|TWO_SIDED|95.0|-2.95|0.22|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.22|-2.95|0.0919
73896377|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.3998||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.3998
73896378|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.8838||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.8838
73896379|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.4012||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.4012
73813933|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.86||0.2285|TWO_SIDED|95.0|-6.0|1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 35||1.4|-6.0|0.2285
73813934|NCT03000530|147177455|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.86||0.212|TWO_SIDED|95.0|-6.0|1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 42||1.4|-6.0|0.2120
73813935|NCT03000530|147177456|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0884|TWO_SIDED|95.0|0.8|24.1|||Generalized Estimating Equation|Statistics are from a generalized estimating equation (GEE) method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 2||24.1|0.8|0.0884
73813936|NCT03000530|147177456|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0732|TWO_SIDED|95.0|0.9|6.4|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||6.4|0.9|0.0732
73813937|NCT03000530|147177456|SUPERIORITY||Odds Ratio (OR)|9.6||||0.0002|TWO_SIDED|95.0|2.9|31.6|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||31.6|2.9|0.0002
73813938|NCT03000530|147177456|SUPERIORITY||Odds Ratio (OR)|6.7||||0.0006|TWO_SIDED|95.0|2.3|19.7|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||19.7|2.3|0.0006
73813939|NCT03000530|147177456|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0379|TWO_SIDED|95.0|1.1|8.9|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||8.9|1.1|0.0379
73813940|NCT03000530|147177456|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0468|TWO_SIDED|95.0|1.0|9.0|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||9.0|1.0|0.0468
73813941|NCT03000530|147177456|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2208|TWO_SIDED|95.0|0.7|5.6|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||5.6|0.7|0.2208
73813942|NCT03000530|147177457|SUPERIORITY||Odds Ratio (OR)|1.5||||0.43|TWO_SIDED|95.0|0.6|3.7|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||3.7|0.6|0.4300
73813943|NCT03000530|147177457|SUPERIORITY||Odds Ratio (OR)|5.3||||0.0005|TWO_SIDED|95.0|2.1|13.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||13.3|2.1|0.0005
73813944|NCT03000530|147177457|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0172|TWO_SIDED|95.0|1.2|8.0|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||8.0|1.2|0.0172
73813945|NCT03000530|147177457|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0221|TWO_SIDED|95.0|1.2|7.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||7.3|1.2|0.0221
73813946|NCT03000530|147177457|SUPERIORITY||Odds Ratio (OR)|1.4||||0.4139|TWO_SIDED|95.0|0.6|3.5|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||3.5|0.6|0.4139
73813947|NCT03000530|147177457|SUPERIORITY||Odds Ratio (OR)|1.7||||0.2332|TWO_SIDED|95.0|0.7|4.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||4.3|0.7|0.2332
73813948|NCT03000530|147177458|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.38||0.0836|TWO_SIDED|95.0|-5.1|0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 2||0.3|-5.1|0.0836
73896380|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.6131||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.6131
73896381|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.5964||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.5964
73813949|NCT03000530|147177458|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.32||0.0864|TWO_SIDED|95.0|-8.6|0.6|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 8||0.6|-8.6|0.0864
73813950|NCT03000530|147177458|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|2.38||0.0021|TWO_SIDED|95.0|-12.3|-2.8|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 15||-2.8|-12.3|0.0021
73813951|NCT03000530|147177458|SUPERIORITY||Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.69||0.0157|TWO_SIDED|95.0|-12.0|-1.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 21||-1.3|-12.0|0.0157
73896382|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.254||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.2540
73896383|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.8524||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.8524
73813952|NCT03000530|147177458|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.69||0.0533|TWO_SIDED|95.0|-10.6|0.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 28||0.1|-10.6|0.0533
73813953|NCT03000530|147177458|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.87||0.2878|TWO_SIDED|95.0|-8.8|2.6|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 35||2.6|-8.8|0.2878
73813954|NCT03000530|147177458|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.7||0.4664|TWO_SIDED|95.0|-7.4|3.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 42||3.4|-7.4|0.4664
73813955|NCT03000530|147177461|SUPERIORITY||Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.87||0.0391|TWO_SIDED|95.0|-3.6|-0.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 2||-0.1|-3.6|0.0391
73813956|NCT03000530|147177461|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.29||0.0516|TWO_SIDED|95.0|-5.1|0.0|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 8||0.0|-5.1|0.0516
73813957|NCT03000530|147177461|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.32||0.0008|TWO_SIDED|95.0|-7.3|-2.0|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 15||-2.0|-7.3|0.0008
73813958|NCT03000530|147177461|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.54||0.0282|TWO_SIDED|95.0|-6.5|-0.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 21||-0.4|-6.5|0.0282
73813959|NCT03000530|147177461|SUPERIORITY||Least Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.56||0.1686|TWO_SIDED|95.0|-5.3|0.9|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 28||0.9|-5.3|0.1686
73813960|NCT03000530|147177461|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.75||0.2488|TWO_SIDED|95.0|-5.5|1.5|||Mixed Effect Model for Repeated Measures|||Day 35||1.5|-5.5|0.2488
73813961|NCT03000530|147177461|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.76||0.2037|TWO_SIDED|95.0|-5.7|1.2|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 42||1.2|-5.7|0.2037
73813962|NCT03000530|147177462|SUPERIORITY||Odds Ratio (OR)|5.5||||0.0048|TWO_SIDED|95.0|1.7|17.9|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||17.9|1.7|0.0048
73896384|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.6969||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.6969
73896385|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.3108||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.3108
73896386|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.8719||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.8719
73896387|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.6105||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.6105
73896388|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.0709||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.0709
73896389|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.9574||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.9574
73813963|NCT03000530|147177462|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0007|TWO_SIDED|95.0|2.5|29.5|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||29.5|2.5|0.0007
73813964|NCT03000530|147177462|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0113|TWO_SIDED|95.0|1.4|13.6|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||13.6|1.4|0.0113
73813965|NCT03000530|147177462|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0227|TWO_SIDED|95.0|1.2|12.8|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||12.8|1.2|0.0227
73813966|NCT03000530|147177462|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1516|TWO_SIDED|95.0|0.7|7.2|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||7.2|0.7|0.1516
73813967|NCT03000530|147177462|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0793|TWO_SIDED|95.0|0.9|8.3|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||8.3|0.9|0.0793
73813968|NCT01430624|147177467|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||6 month follow-up comparison|ANOVA|df 2, 109||||||.24
73813969|NCT01430624|147177468|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||6 month follow-up comparison|ANOVA|df = 2, 111||||||.89
73813970|NCT01430624|147177469|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 150||||||.01
73813971|NCT01430624|147177469|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||3 month comparison|ANOVA|||||||.48
73896390|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.231||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.2310
73896391|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.0672||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.0672
73813972|NCT01430624|147177469|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||6 month comparison|ANOVA|||||||.17
73813973|NCT01430624|147177470|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||6 week comparison|Chi-squared|df = 2, 154||||||.37
73813974|NCT01430624|147177470|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||3 month comparison|Chi-squared|df = 2, 135||||||.15
73813975|NCT01430624|147177470|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||6 month comparison|Chi-squared|df = 2, 121||||||.87
73813976|NCT01430624|147177471|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 150||||||.63
73813977|NCT01430624|147177471|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.25
73813978|NCT01430624|147177471|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 118||||||.59
73813979|NCT01430624|147177472|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 151||||||.83
73813980|NCT01430624|147177472|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.29
73813981|NCT01430624|147177472|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 118||||||.13
73813982|NCT01430624|147177473|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 151||||||.012
73896392|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.8441||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.8441
73813983|NCT01430624|147177473|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.31
73813984|NCT01430624|147177473|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED|||||6 month comparison|ANOVA|df = 2,116||||||.35
73896393|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.6741||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.6741
73896394|NCT00797966|147326200|SUPERIORITY_OR_OTHER|||||||0.0183||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.0183
73813985|NCT01430624|147177474|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 141||||||.15
73813986|NCT01430624|147177474|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 127||||||.67
73813987|NCT01430624|147177474|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 110||||||.40
73813988|NCT00625404|147177513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.59|1.52||||||Hazard ratio (HR) for HIV infection based on proportional hazards model, stratified on site. Study was designed to have 90% power to reject the null hypothesis that the HR for infection is \> 0.3||1.52|0.59|
73813989|NCT00625404|147177514|SUPERIORITY_OR_OTHER|||||||0.45|||||||Log Rank|||Log-rank test for difference in rate of grade 2 or higher creatinine, based on time to first event.||||0.45
73813990|NCT00625404|147177516|SUPERIORITY_OR_OTHER|||||||0.59|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.59
73813991|NCT00625404|147177517|SUPERIORITY_OR_OTHER|||||||0.79|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.79
73813992|NCT00625404|147177518|SUPERIORITY_OR_OTHER|||||||0.62|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.62
73813993|NCT00625404|147177519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.89|||||||t-test, 2 sided|||t-test for difference on viral loads||||0.89
73813994|NCT00625404|147177520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.1||||0.82|||||||t-test, 2 sided|||t-test for difference in mean CD-4 counts||||0.82
73813995|NCT00625404|147177524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.73|||||||t-test, 2 sided|||t-test for difference in change in number of sexual partners over time||||0.73
73813996|NCT05079230|147177629|SUPERIORITY||Hazard Ratio (HR)|1.178||||0.3276|TWO_SIDED|95.0|0.848|1.637|||stratified log-rank test|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI were calculated using the stratified cox proportional hazards model.|||1.637|0.848|0.3276
73813997|NCT05079230|147177630|SUPERIORITY||Stratified Odds Ratio|0.826||||0.3616|TWO_SIDED|95.0|0.545|1.251|||Stratum-adjusted Mantel-Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.251|0.545|0.3616
73813998|NCT05079230|147177631|SUPERIORITY||Stratified Odds Ratio|0.856||||0.4679|TWO_SIDED|95.0|0.56|1.307|||Stratum-adjusted Mantel-Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.307|0.560|0.4679
73813999|NCT05079230|147177632|SUPERIORITY||Stratified Hazard Ratio|0.946||||0.7903|TWO_SIDED|95.0|0.73|1.225|||Stratified Log Rank||The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|||1.225|0.730|0.7903
73814000|NCT05079230|147177635|SUPERIORITY||Stratified Odds Ratio|1.189||||0.4873|TWO_SIDED|95.0|0.727|1.945|||Stratum-adjusted Mantel Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.945|0.727|0.4873
73814001|NCT05079230|147177636|SUPERIORITY||Stratified Odds Ratio|1.154||||0.5842|TWO_SIDED|95.0|0.69|1.932|||Stratum-adjusted Mantel Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.932|0.690|0.5842
73814002|NCT05079230|147177637|SUPERIORITY||Stratified Odds Ratio|0.783||||0.3003|TWO_SIDED|95.0|0.492|1.245|||Cochran-Mantel-Haenszel||The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).|||1.245|0.492|0.3003
73814003|NCT05079230|147177638|SUPERIORITY||Stratified Odds Ratio|1.21||||0.579|TWO_SIDED|95.0|0.62|2.36||The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).|Cochran-Mantel-Haenszel|||||2.360|0.620|0.5790
73814004|NCT05079230|147177639|SUPERIORITY||Stratified Hazard Ratio|1.09||||0.5796|TWO_SIDED|95.0|0.799|1.487|||Stratified Log Rank|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI are calculated using the stratified cox proportional hazards model.|||1.487|0.799|0.5796
73814005|NCT05079230|147177640|SUPERIORITY||Stratified Hazard Ratio|1.271||||0.1026|TWO_SIDED|95.0|0.948|1.704|||Stratified Log Rank|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI were calculated using the stratified cox proportional hazards model.|||1.704|0.948|0.1026
73814006|NCT01524783|147177646|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.35|0.67|||Log Rank|||||0.67|0.35|<0.001
73814007|NCT01524783|147177647|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.259|TWO_SIDED|95.0|0.66|1.24|||Log Rank|||||1.24|0.66|0.259
73814008|NCT01524783|147177650|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.073|TWO_SIDED|95.0|0.5|1.1|||Log Rank|||||1.10|0.50|0.073
73814009|NCT01524783|147177653|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.539|TWO_SIDED|95.0|0.65|1.61|||Log Rank|||||1.61|0.65|0.539
73814010|NCT05153148|147177661|SUPERIORITY||Risk Difference (RD)|5.9|||=|0.446|TWO_SIDED|95.0|-9.3|21.1|||Cochran-Mantel-Haenszel||Mantel-Haenszel (MH) risk difference was summarized along with the 2-sided 95% confidence interval (CI) using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional disease-modifying antirheumatic drugs (DMARDs) and region.|21.1|-9.3|=0.446
73814011|NCT05153148|147177661|SUPERIORITY||Risk Difference (RD)|24.1|||=|0.002|TWO_SIDED|95.0|8.6|39.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|39.6|8.6|=0.002
73814012|NCT05153148|147177661|SUPERIORITY||Risk Difference (RD)|24.5|||=|0.002|TWO_SIDED|95.0|9.0|39.9|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|39.9|9.0|=0.002
73814013|NCT05153148|147177662|SUPERIORITY||Risk Difference (RD)|5.7|||=|0.312|TWO_SIDED|95.0|-5.3|16.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|16.6|-5.3|=0.312
73814014|NCT05153148|147177662|SUPERIORITY||Risk Difference (RD)|17.0|||=|0.005|TWO_SIDED|95.0|5.0|29.1|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.1|5.0|=0.005
73814015|NCT05153148|147177662|SUPERIORITY||Risk Difference (RD)|16.4|||=|0.009|TWO_SIDED|95.0|4.2|28.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|28.6|4.2|=0.009
73814016|NCT05153148|147177663|SUPERIORITY||Risk Difference (RD)|2.9|||=|0.532|TWO_SIDED|95.0|-6.6|12.7|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||12.7|-6.6|=0.532
73814017|NCT05153148|147177663|SUPERIORITY||Risk Difference (RD)|9.1|||=|0.101|TWO_SIDED|95.0|-1.0|20.1|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||20.1|-1.0|=0.101
73814018|NCT05153148|147177663|SUPERIORITY||Risk Difference (RD)|8.3|||=|0.158|TWO_SIDED|95.0|-1.7|19.4|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||19.4|-1.7|=0.158
73814019|NCT05153148|147177664|SUPERIORITY||Treatment Difference|-1.7|||=|0.268|TWO_SIDED|95.0|-4.8|1.3|||Mixed Model Repeated Measure (MMRM)||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-4.8|=0.268
73814020|NCT05153148|147177664|SUPERIORITY||Treatment Difference|-3.0|||=|0.051|TWO_SIDED|95.0|-6.1|0.0|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.0|-6.1|=0.051
73896395|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.49||||0.3007|TWO_SIDED|95.0|0.12|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.93|0.12|0.3007
73896396|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.94||||0.8812|TWO_SIDED|95.0|0.42|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||2.10|0.42|0.8812
73896397|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.32||||0.0553|TWO_SIDED|95.0|0.1|1.07||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.07|0.10|0.0553
73896398|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.78||||0.6051|TWO_SIDED|95.0|0.3|2.05||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.05|0.30|0.6051
73814021|NCT05153148|147177664|SUPERIORITY||Treatment Difference|-2.5|||=|0.112|TWO_SIDED|95.0|-5.6|0.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.6|-5.6|=0.112
73814022|NCT05153148|147177665|SUPERIORITY||Treatment Difference|-0.9|||=|0.28|TWO_SIDED|95.0|-2.4|0.7|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.7|-2.4|=0.280
73814023|NCT05153148|147177665|SUPERIORITY||Treatment Difference|-1.1|||=|0.177|TWO_SIDED|95.0|-2.6|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-2.6|=0.177
73814024|NCT05153148|147177665|SUPERIORITY||Treatment Difference|-1.0|||=|0.196|TWO_SIDED|95.0|-2.6|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-2.6|=0.196
73814025|NCT05153148|147177666|SUPERIORITY||Treatment Difference|-1.9|||=|0.637|TWO_SIDED|95.0|-9.6|5.9|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|5.9|-9.6|=0.637
73814026|NCT05153148|147177666|SUPERIORITY||Treatment Difference|-9.2|||=|0.021|TWO_SIDED|95.0|-17.0|-1.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.4|-17.0|=0.021
73896399|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.92||||0.8264|TWO_SIDED|95.0|0.46|1.85||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.85|0.46|0.8264
73896400|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.869|TWO_SIDED|95.0|0.54|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.10|0.54|0.8690
73814027|NCT05153148|147177666|SUPERIORITY||Treatment Difference|-8.7|||=|0.03|TWO_SIDED|95.0|-16.5|-0.9|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-0.9|-16.5|=0.030
73814028|NCT05153148|147177667|SUPERIORITY||Treatment Difference|-0.9|||=|0.812|TWO_SIDED|95.0|-8.4|6.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|6.6|-8.4|=0.812
73814029|NCT05153148|147177667|SUPERIORITY||Treatment Difference|-6.7|||=|0.079|TWO_SIDED|95.0|-14.2|0.8|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.8|-14.2|=0.079
73814030|NCT05153148|147177667|SUPERIORITY||Treatment Difference|-6.3|||=|0.102|TWO_SIDED|95.0|-13.9|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-13.9|=0.102
73896401|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.35||||0.3441|TWO_SIDED|95.0|0.74|2.44||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.44|0.74|0.3441
73896402|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.14||||0.6375|TWO_SIDED|95.0|0.67|1.94||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.94|0.67|0.6375
73896403|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.31||||0.3135|TWO_SIDED|95.0|0.78|2.21||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.21|0.78|0.3135
73896404|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|2.35||||0.0035|TWO_SIDED|95.0|1.32|4.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||4.18|1.32|0.0035
73814031|NCT05153148|147177668|SUPERIORITY||Treatment Difference|-8.9|||=|0.016|TWO_SIDED|95.0|-16.2|-1.7|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.7|-16.2|=0.016
73814032|NCT05153148|147177668|SUPERIORITY||Treatment Difference|-10.6|||=|0.004|TWO_SIDED|95.0|-17.8|-3.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-3.4|-17.8|=0.004
73814033|NCT05153148|147177668|SUPERIORITY||Treatment Difference|-10.9|||=|0.003|TWO_SIDED|95.0|-18.2|-3.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-3.6|-18.2|=0.003
73814034|NCT05153148|147177669|SUPERIORITY||Treatment Difference|-0.07|||=|0.357|TWO_SIDED|95.0|-0.21|0.08|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.08|-0.21|=0.357
73814035|NCT05153148|147177669|SUPERIORITY||Treatment Difference|-0.1|||=|0.195|TWO_SIDED|95.0|-0.24|0.05|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.05|-0.24|=0.195
73814036|NCT05153148|147177669|SUPERIORITY||Treatment Difference|-0.05|||=|0.467|TWO_SIDED|95.0|-0.2|0.09|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.09|-0.20|=0.467
73814037|NCT05153148|147177670|SUPERIORITY||Treatment Difference|1.3|||=|0.031|TWO_SIDED|95.0|0.1|2.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|2.4|0.1|=0.031
73814038|NCT05153148|147177670|SUPERIORITY||Treatment Difference|0.1|||=|0.86|TWO_SIDED|95.0|-1.1|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-1.1|=0.860
73814039|NCT05153148|147177670|SUPERIORITY||Treatment Difference|0.2|||=|0.758|TWO_SIDED|95.0|-0.9|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-0.9|=0.758
73814040|NCT05153148|147177671|SUPERIORITY||Treatment Difference|-0.5|||=|0.131|TWO_SIDED|95.0|-1.2|0.2|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.2|-1.2|=0.131
73814041|NCT05153148|147177671|SUPERIORITY||Treatment Difference|-0.7|||=|0.043|TWO_SIDED|95.0|-1.3|0.0|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.0|-1.3|=0.043
73814042|NCT05153148|147177671|SUPERIORITY||Treatment Difference|-0.1|||=|0.687|TWO_SIDED|95.0|-0.8|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-0.8|=0.687
73814043|NCT05153148|147177672|SUPERIORITY||Risk Difference (RD)|5.6|||=|0.349|TWO_SIDED|95.0|-6.1|17.4|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|17.4|-6.1|=0.349
73814044|NCT05153148|147177672|SUPERIORITY||Risk Difference (RD)|15.5|||=|0.017|TWO_SIDED|95.0|2.8|28.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|28.3|2.8|=0.017
73896405|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.4358|TWO_SIDED|95.0|0.7|2.31||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||2.31|0.70|0.4358
73896406|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|2.02||||0.0063|TWO_SIDED|95.0|1.2|3.41||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.41|1.20|0.0063
73814045|NCT05153148|147177672|SUPERIORITY||Risk Difference (RD)|16.3|||=|0.014|TWO_SIDED|95.0|3.3|29.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.3|3.3|=0.014
73814046|NCT05153148|147177673|SUPERIORITY||Treatment Difference|-3.73|||=|0.167|TWO_SIDED|95.0|-9.04|1.57|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.57|-9.04|=0.167
73814047|NCT05153148|147177673|SUPERIORITY||Treatment Difference|-6.43|||=|0.018|TWO_SIDED|95.0|-11.73|-1.13|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.13|-11.73|=0.018
73814048|NCT05153148|147177673|SUPERIORITY||Treatment Difference|-5.23|||=|0.056|TWO_SIDED|95.0|-10.59|0.13|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.13|-10.59|=0.056
73814049|NCT05153148|147177674|SUPERIORITY||Risk Difference (RD)|11.9|||=|0.186|TWO_SIDED|95.0|-5.7|29.4|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.4|-5.7|=0.186
73814050|NCT05153148|147177674|SUPERIORITY||Risk Difference (RD)|14.6|||=|0.101|TWO_SIDED|95.0|-2.8|32.1|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|32.1|-2.8|=0.101
73814051|NCT05153148|147177674|SUPERIORITY||Risk Difference (RD)|29.0|||=|0.002|TWO_SIDED|95.0|10.5|47.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|47.6|10.5|=0.002
73814052|NCT05153148|147177675|SUPERIORITY||Risk Difference (RD)|4.5|||=|0.54|TWO_SIDED|95.0|-10.0|19.0|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|19.0|-10.0|=0.540
73814053|NCT05153148|147177675|SUPERIORITY||Risk Difference (RD)|5.2|||=|0.466|TWO_SIDED|95.0|-8.8|19.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|19.3|-8.8|=0.466
73814054|NCT05153148|147177675|SUPERIORITY||Risk Difference (RD)|16.3|||=|0.034|TWO_SIDED|95.0|1.2|31.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|31.3|1.2|=0.034
73814055|NCT01712334|147177678|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of the mean percent predicted FEV1 at the end of the eRapid treatment to the mean percent predicted FEV1 at the end of the LC Plus jet nebulizer treatment. The two nebulizers were considered equivalent if the 90% CI was within 80%-125%.|Ratio (Fieller's theorem)|100.9|||||TWO_SIDED|90.0|99.5|102.3||||||||102.3|99.5|
73814056|NCT01253174|147177684|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|102.26||||||90.0|96.65|108.2||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||108.20|96.65|
73896407|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.3968|TWO_SIDED|95.0|0.72|2.23||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.23|0.72|0.3968
73896408|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.299|TWO_SIDED|95.0|0.81|2.0||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.00|0.81|0.2990
73896409|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.39||||0.1614|TWO_SIDED|95.0|0.86|2.25||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.25|0.86|0.1614
73896410|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.29||||0.3254|TWO_SIDED|95.0|0.79|2.12||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.12|0.79|0.3254
73814057|NCT01253174|147177685|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|101.13||||||90.0|97.65|104.75||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.75|97.65|
73814058|NCT01253174|147177686|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.66||||||90.0|93.37|104.24||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.24|93.37|
73814059|NCT01253174|147177687|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.45||||||90.0|96.7|102.28||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||102.28|96.70|
73814060|NCT01253174|147177688|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.19||||||90.0|99.18|113.68||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.68|99.18|
73814061|NCT01253174|147177689|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|97.98||||||90.0|94.19|101.93||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||101.93|94.19|
73814062|NCT01253174|147177690|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|104.9||||||90.0|98.83|111.34||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||111.34|98.83|
73814063|NCT01253174|147177691|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.63||||||90.0|95.73|103.69||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.69|95.73|
73814064|NCT01253174|147177693|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.57||||||90.0|97.32|101.87||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||101.87|97.32|
73896411|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.02||||0.9463|TWO_SIDED|95.0|0.64|1.62||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.62|0.64|0.9463
73896412|NCT00797966|147326201|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.74||||0.008|TWO_SIDED|95.0|1.14|2.65||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.65|1.14|0.0080
73896413|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.59||||0.5791|TWO_SIDED|95.0|0.09|3.9||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||3.90|0.09|0.5791
73896414|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.43||||0.2653|TWO_SIDED|95.0|0.1|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.93|0.10|0.2653
73814065|NCT02267135|147177696|SUPERIORITY_OR_OTHER_LEGACY||Difference between percentages|51.0|||<|0.001|TWO_SIDED|95.0|37.0|65.0|||Cochran-Mantel-Haenszel|adjusted for body weight (\< 90 kg, ≥ 90 kg)||||65|37|<0.001
73814066|NCT02892513|147177709|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
73814067|NCT01172808|147177757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.181|0.291|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.291|0.181|<0.0001
73814068|NCT01172808|147177757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.142|0.253|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre , week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.253|0.142|<0.0001
73814069|NCT01172808|147177758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.126|0.244|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.244|0.126|<0.0001
73814070|NCT01172808|147177758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.092|0.211|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction.||0.211|0.092|<0.0001
73814071|NCT01172808|147177759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.114|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.233|0.114|<0.0001
73814072|NCT01172808|147177759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.031||0.0008|TWO_SIDED|95.0|0.042|0.162|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model. Spatial power used as covariance structure. The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||0.162|0.042|0.0008
73814073|NCT01172808|147177760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.032||0.0001|TWO_SIDED|95.0|0.062|0.189|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.189|0.062|0.0001
73814074|NCT01172808|147177760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.033||0.02|TWO_SIDED|95.0|0.012|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.140|0.012|0.0200
73896415|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.39||||0.2259|TWO_SIDED|95.0|0.08|1.87||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.87|0.08|0.2259
73814075|NCT01172808|147177761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.171|0.278|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.278|0.171|<0.0001
73896416|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.83||||0.6986|TWO_SIDED|95.0|0.32|2.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.18|0.32|0.6986
73814076|NCT01172808|147177761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.141|0.249|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.249|0.141|<0.0001
73814077|NCT01172808|147177762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.1|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.215|0.100|<0.0001
73896417|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.61||||0.2339|TWO_SIDED|95.0|0.28|1.35||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.35|0.28|0.2339
73814078|NCT01172808|147177762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.029||0.0003|TWO_SIDED|95.0|0.049|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.164|0.049|0.0003
73814079|NCT01172808|147177763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.907|STANDARD_ERROR_OF_MEAN|4.994|<|0.0001|TWO_SIDED|95.0|28.113|47.7|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||47.700|28.113|<0.0001
73814080|NCT01172808|147177763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.677|STANDARD_ERROR_OF_MEAN|5.023|<|0.0001|TWO_SIDED|95.0|23.825|43.529|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||43.529|23.825|<0.0001
73814081|NCT01172808|147177764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.066||0.2717|TWO_SIDED|95.0|-0.057|0.203|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.203|-0.057|0.2717
73814082|NCT01172808|147177764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.067||0.2956|TWO_SIDED|95.0|-0.061|0.201|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.201|-0.061|0.2956
73814083|NCT01172808|147177765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.059||0.0007|TWO_SIDED|95.0|-0.318|-0.085|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.085|-0.318|0.0007
73814084|NCT01172808|147177765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.06||0.0262|TWO_SIDED|95.0|-0.25|-0.016|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.016|-0.250|0.0262
73814085|NCT01172808|147177766|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0377|TWO_SIDED|95.0|1.02|2.11||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||2.11|1.02|0.0377
73814086|NCT01172808|147177766|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.0022|TWO_SIDED|95.0|1.22|2.54||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||2.54|1.22|0.0022
73814087|NCT01172808|147177767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.591|STANDARD_ERROR_OF_MEAN|4.52|<|0.0001|TWO_SIDED|95.0|21.726|39.455|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||39.455|21.726|<0.0001
73814088|NCT01172808|147177767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.66|STANDARD_ERROR_OF_MEAN|4.533|<|0.0001|TWO_SIDED|95.0|14.772|32.549|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||32.549|14.772|<0.0001
73896418|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.07||||0.8615|TWO_SIDED|95.0|0.53|2.15||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.15|0.53|0.8615
73814089|NCT01172808|147177768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.16|STANDARD_ERROR_OF_MEAN|4.447|<|0.0001|TWO_SIDED|95.0|19.44|36.88|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||36.880|19.440|<0.0001
73814090|NCT01172808|147177768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.37|STANDARD_ERROR_OF_MEAN|4.462|<|0.0001|TWO_SIDED|95.0|15.619|33.12|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||33.120|15.619|<0.0001
73896419|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.06||||0.8807|TWO_SIDED|95.0|0.51|2.2||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.20|0.51|0.8807
73814091|NCT01172808|147177769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.603||0.355|TWO_SIDED|95.0|-1.74|0.624|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.624|-1.740|0.3550
73814092|NCT01172808|147177769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|0.608||0.0094|TWO_SIDED|95.0|0.388|2.771|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||2.771|0.388|0.0094
73814093|NCT01172808|147177770|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.03||0.0069|TWO_SIDED|95.0|0.022|0.139|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.139|0.022|0.0069
73814094|NCT01172808|147177770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.03||0.081|TWO_SIDED|95.0|-0.006|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.111|-0.006|0.0810
73814095|NCT01172808|147177771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.031||0.0363|TWO_SIDED|95.0|0.004|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.126|0.004|0.0363
73814096|NCT01172808|147177771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.031||0.2077|TWO_SIDED|95.0|-0.022|0.1|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.100|-0.022|0.2077
73814097|NCT01172808|147177772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.162|STANDARD_ERROR_OF_MEAN|0.14||0.2447|TWO_SIDED|95.0|-0.436|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.111|-0.436|0.2447
73814098|NCT01172808|147177772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.14||0.3046|TWO_SIDED|95.0|-0.131|0.419|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.419|-0.131|0.3046
73814099|NCT01172808|147177773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.029||0.1178|TWO_SIDED|95.0|-0.011|0.102|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.102|-0.011|0.1178
73814100|NCT01172808|147177773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.029||0.888|TWO_SIDED|95.0|-0.061|0.053|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.053|-0.061|0.8880
73896420|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.96||||0.9035|TWO_SIDED|95.0|0.52|1.77||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.77|0.52|0.9035
73896421|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.19||||0.5898|TWO_SIDED|95.0|0.64|2.24|||Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.24|0.64|0.5898
73896422|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.82||||0.084|TWO_SIDED|95.0|0.93|3.58||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.58|0.93|0.0840
73814101|NCT01172808|147177774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.0308|TWO_SIDED|95.0|1.03|1.72||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.72|1.03|0.0308
73896423|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.96||||0.9115|TWO_SIDED|95.0|0.49|1.88||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.88|0.49|0.9115
73814102|NCT01172808|147177774|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0348|TWO_SIDED|95.0|1.02|1.71||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.71|1.02|0.0348
73814103|NCT03246061|147177777|SUPERIORITY||||||<|0.001||||||Interim Analysis p-value for significance of \<0.025 for an overall alpha of 0.05|ANCOVA|||Estimates and p-value from an ANCOVA with a factor of treatment group and a covariate of baseline ODI score. Values have been adjusted for multiple imputation. Note: 3 month visit is computed as post-treatment for the RF Ablation Arm, and post-randomization for the Control Arm.||||<0.001
73814104|NCT03246061|147177778|SUPERIORITY||||||<|0.001||||||Estimates and p-value from ANCOVA with a factor of treatment group and a covariate of baseline VAS score.|ANCOVA|||||||<0.001
73814105|NCT03114657|147177814|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.633|||TWO_SIDED|95.0|0.0|2.6||||||||2.60|0.00|
73814106|NCT03114657|147177815|SUPERIORITY||Least Squares Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|2.028|||TWO_SIDED|95.0|-2.4|5.89||||||||5.89|-2.40|
73814107|NCT03114657|147177816|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|2.124|||TWO_SIDED|95.0|-4.03|4.68||||||||4.68|-4.03|
73814108|NCT03114657|147177817|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.2|0.39||||||||0.39|-0.20|
73814109|NCT03114657|147177818|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.985|||TWO_SIDED|95.0|-2.42|1.6||||||||1.60|-2.42|
73814110|NCT03114657|147177819|SUPERIORITY||Least Squares Mean Difference|-2.52|STANDARD_ERROR_OF_MEAN|3.052|||TWO_SIDED|95.0|-8.74|3.7||||||||3.70|-8.74|
73814111|NCT03114657|147177820|SUPERIORITY||Least Squares Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|2.501|||TWO_SIDED|95.0|-6.29|3.92||||||||3.92|-6.29|
73814112|NCT03114657|147177821|SUPERIORITY||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|-2.25|3.51||||||||3.51|-2.25|
73814113|NCT03114657|147177823|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.502|||TWO_SIDED|95.0|-1.75|0.23||||||||0.23|-1.75|
73814114|NCT03114657|147177824|SUPERIORITY||Least Squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|1.383|||TWO_SIDED|95.0|-3.3|2.39||||||||2.39|-3.30|
73814115|NCT03114657|147177825|SUPERIORITY||Least Squares Mean Difference|6.55|STANDARD_ERROR_OF_MEAN|5.527|||TWO_SIDED|95.0|-4.35|17.44||||||||17.44|-4.35|
73814116|NCT03114657|147177826|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|5.831|||TWO_SIDED|95.0|-12.31|11.71||||||||11.71|-12.31|
73814117|NCT03114657|147177827|SUPERIORITY||Least Squares Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|3.94|||TWO_SIDED|95.0|-11.5|4.73||||||||4.73|-11.50|
73814118|NCT03114657|147177833|SUPERIORITY||Least Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.622|||TWO_SIDED|95.0|-2.01|0.89||||||||0.89|-2.01|
73814119|NCT03114657|147177834|SUPERIORITY||Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.668|||TWO_SIDED|95.0|-1.7|4.9||||||||4.90|-1.70|
73814120|NCT03114657|147177835|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.373|||TWO_SIDED|95.0|-1.13|0.41||||||||0.41|-1.13|
73814121|NCT01075399|147177836|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.883|||<|0.001|TWO_SIDED|90.0|0.802|0.929||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV max:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing SUV max of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."||0.929|0.802|<0.001
73814122|NCT01075399|147177836|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.887|||<|0.001|TWO_SIDED|90.0|0.792|0.925||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV mean:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing SUV mean of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."||0.925|0.792|<0.001
73814123|NCT01075399|147177836|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.945|||<|0.001|TWO_SIDED|90.0|0.904|0.967||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor to background SUV ratio:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing tumor to background SUV ratio (T/B) of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in T/B values, and for establishing reproducibility within ±20% or ±25%."||0.967|0.904|<0.001
73814124|NCT01546038|147177842|OTHER||Hazard Ratio (HR)|0.569||||0.002|TWO_SIDED|80.0|0.441|0.734||1-sided p-value from the log-rank test stratified by prognosis stratum according to Interactive Voice Response System (IVRS).|Log Rank||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.|||0.734|0.441|0.0020
73814125|NCT01546038|147177846|OTHER||Odds Ratio (OR)|4.2755||||0.0112|TWO_SIDED|80.0|1.3057|13.9994|||Cochran-Mantel-Haenszel||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.|||13.9994|1.3057|0.0112
73814126|NCT04245202|147177910|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73814127|NCT04245202|147177911|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73814128|NCT04245202|147177912|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73814129|NCT04245202|147177913|OTHER||Mean Difference (Net)|-12.29|STANDARD_DEVIATION|5.72|<|0.001|TWO_SIDED|95.0|-23.53|-1.05||The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.|Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||-1.05|-23.53|<0.001
73814130|NCT04245202|147177914|OTHER||Mean Difference (Net)|-12.66|STANDARD_DEVIATION|4.77|<|0.001|TWO_SIDED|95.0|-22.05|-3.28|||Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.||-3.28|-22.05|<0.001
73814131|NCT04245202|147177915|OTHER||Mean Difference (Net)|-3.91|STANDARD_DEVIATION|2.43|<|0.001|TWO_SIDED|95.0|-8.68|0.86||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||0.86|-8.68|<0.001
73814132|NCT04245202|147177916|OTHER||Mean Difference (Net)|-2.41|STANDARD_DEVIATION|2.14||0.003|TWO_SIDED|95.0|-6.62|1.78|||Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.||1.78|-6.62|0.003
73814133|NCT04245202|147177917|OTHER||Relative treatment effect difference|-0.07||||0.002|TWO_SIDED|||||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Brunner-Langer Method||Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||||0.002
73814134|NCT04245202|147177918|OTHER||Relative treatment effect difference|-0.08||||0.001|TWO_SIDED|95.0||||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Brunner-Langer Method||Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||||0.001
73814135|NCT04245202|147177920|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
73814136|NCT04245202|147177921|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
73814137|NCT04245202|147177922|OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
73814138|NCT04245202|147177923|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
73814139|NCT04245202|147177924|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
73896424|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.77||||0.0522|TWO_SIDED|95.0|0.98|3.17||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.17|0.98|0.0522
73896425|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.24||||0.4997|TWO_SIDED|95.0|0.65|2.34||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.34|0.65|0.4997
73896426|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.16||||0.5846|TWO_SIDED|95.0|0.69|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.93|0.69|0.5846
73814140|NCT04245202|147177925|OTHER|||||||0.08|||||||Fisher Exact|||||||0.08
73814141|NCT02470403|147177926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.7|||<|0.001|TWO_SIDED|80.0|-6.52|-4.87|||Mixed Models Analysis|||"This analysis included all subjects. The following criteria were assessed:~1. upper confidence limit of the 80% CI for treatment difference (LIK066 - placebo) was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-4.87|-6.52|<0.001
73814142|NCT02470403|147177926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.85|||<|0.001|TWO_SIDED|80.0|-7.96|-5.73|||Mixed Models Analysis|||"This analysis included dysglycemic subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-5.73|-7.96|<0.001
73814143|NCT02470403|147177926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.55|||<|0.001|TWO_SIDED|80.0|-5.76|-3.34|||Mixed Models Analysis|||"This analysis included normoglycemic subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-3.34|-5.76|<0.001
73814144|NCT02470403|147177928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.83|||<|0.001|TWO_SIDED|80.0|-2.16|-1.51|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-1.51|-2.16|<0.001
73814145|NCT02470403|147177928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.39|||<|0.001|TWO_SIDED|80.0|-2.94|-1.84|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-1.84|-2.94|<0.001
73814146|NCT02470403|147177928|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.38|||<|0.001|TWO_SIDED|80.0|-2.93|-1.83|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%"||-1.83|-2.93|<0.001
73814147|NCT00987402|147177970|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||generalized estimating equation|||Power calculations assumed a 2-sided alpha error of 0.05 and a power of 80%. We performed power calculations using a statistical model for a cluster-randomized trial with 8, 10 or 12 clusters including 6 operating rooms each, with different levels of reduction (10%, 30%, 50%) in surgical site infection rates in the active intervention period. By reaching a sample size of 3133 patients, the study was powered to detect a 30% reduction effect in SSI rates, from 10% to 7%.||||<0.05
73814148|NCT00568334|147177992|NON_INFERIORITY|The lower limit (LL) of the 95% confidence interval (CI) for the GMT ratio (derived from IFA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.5.|GMT Ratio|1.12|||||TWO_SIDED|95.0|0.86|1.46|||ANOVA|||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean titers (GMTs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.||1.46|0.86|
73814149|NCT00568334|147177993|NON_INFERIORITY|The lower limit (LL) of the 95% confidence interval (CI) for the GMC ratio (derived from ELISA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.67.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.93|1.33|||ANOVA|||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean concentrations (GMCs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.||1.33|0.93|
73814150|NCT00306787|147178002|NON_INFERIORITY_OR_EQUIVALENCE|The estimated power for non-inferiority test (90%) was based on the non-inferiority margin of 1.0 day.|Median Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.15|0.6|||Hodges-Lehman|||Difference in time to healing= time to healing for famciclovir- time to healing for valacyclovir.||0.60|-0.15|
73814151|NCT02273908|147178008|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.949|||<|0.001|TWO_SIDED|95.0|-1.459|-0.439|||Mixed Models Analysis|||||-0.439|-1.459|<0.001
73814152|NCT02273908|147178009|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.259|||<|0.001|TWO_SIDED|95.0|-3.131|-1.387|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||-1.387|-3.131|<0.001
73814153|NCT02273908|147178009|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.887|||<|0.001|TWO_SIDED|95.0|-2.704|-1.071|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||-1.071|-2.704|<0.001
73814154|NCT02273908|147178010|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3018|||<|0.001|TWO_SIDED|95.0|1.4903|5.1133|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||5.1133|1.4903|<0.001
73814155|NCT02273908|147178010|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|2.729||||0.004|TWO_SIDED|95.0|0.9047|4.5533|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||4.5533|0.9047|0.004
73814156|NCT02273908|147178011|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.301|-0.359|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||-0.359|-1.301|<0.001
73814157|NCT02273908|147178011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.674||||0.004|TWO_SIDED|95.0|-1.125|-0.223|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||-0.223|-1.125|0.004
73814158|NCT02273908|147178012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0204||||0.175|TWO_SIDED|95.0|-0.0091|0.0499|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||0.0499|-0.0091|0.175
73814159|NCT02273908|147178012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0329||||0.017|TWO_SIDED|95.0|0.0058|0.06|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||0.0600|0.0058|0.017
73814160|NCT02273908|147178013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.697||||0.026|TWO_SIDED|95.0|0.552|8.842|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||8.842|0.552|0.026
73814161|NCT02273908|147178013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.292||||0.477|TWO_SIDED|95.0|-2.282|4.866|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||4.866|-2.282|0.477
73814162|NCT02273908|147178014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Modified Chi-squared|||||||<0.001
73814163|NCT02273908|147178015|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Modified Chi-squared|||||||<0.001
73814164|NCT04908475|147178018|SUPERIORITY||Adjusted Difference|50.7|||<|0.001|TWO_SIDED|95.0|41.3|60.1||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\]) for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||60.1|41.3|< 0.001
73814165|NCT04908475|147178019|SUPERIORITY||Adjusted Difference|56.8|||<|0.001|TWO_SIDED|95.0|47.7|66.0||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\]) for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||66.0|47.7|< 0.001
73814166|NCT04908475|147178020|SUPERIORITY||Difference|69.7|||<|0.001|TWO_SIDED|95.0|59.5|80.0|||Chi-squared|||||80.0|59.5|< 0.001
73814167|NCT04908475|147178021|SUPERIORITY||Adjusted Difference|65.9|||<|0.001|TWO_SIDED|95.0|57.6|73.9||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\] for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||73.9|57.6|< 0.001
73814168|NCT04908475|147178022|SUPERIORITY||Difference|71.6|||<|0.001|TWO_SIDED|95.0|60.9|82.3|||Chi-squared|||||82.3|60.9|< 0.001
73814169|NCT04908475|147178023|SUPERIORITY||Difference|69.4|||<|0.001|TWO_SIDED|95.0|58.6|80.2|||Chi-squared|||||80.2|58.6|< 0.001
73814170|NCT01593254|147178034|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
73814171|NCT01887678|147178039|SUPERIORITY_OR_OTHER||Least Square|-6.37|STANDARD_ERROR_OF_MEAN|3.06||0.0383|TWO_SIDED|95.0|-12.4|-0.35|||ANCOVA||A negative value of the Least Square mean difference indicates a result in favor of Traumeel-Zeel.|||-0.35|-12.40|0.0383
73814172|NCT01887678|147178040|SUPERIORITY_OR_OTHER||Least Squares|-2.15||||0.3715|TWO_SIDED|95.0|-6.89|2.58|||ANCOVA|||Day 8±1||2.58|-6.89|0.3715
73814173|NCT01887678|147178040|SUPERIORITY_OR_OTHER||Least Square|-5.87||||0.0293|TWO_SIDED|95.0|-11.15|-0.6|||ANCOVA|||Day 15±1||-0.60|-11.15|0.0293
73814174|NCT01887678|147178040|SUPERIORITY_OR_OTHER||Least Squares|-5.24||||0.0686|TWO_SIDED|95.0|-10.88|0.4|||ANCOVA|||Day 29±3||0.40|-10.88|0.0686
73814175|NCT01887678|147178040|SUPERIORITY_OR_OTHER||Least Squares|-7.25||||0.015|TWO_SIDED|95.0|-13.08|-1.42|||ANCOVA|||Day 43±3||-1.42|-13.08|0.0150
73814176|NCT01887678|147178040|SUPERIORITY_OR_OTHER||Least Squares|-7.56||||0.0134|TWO_SIDED|95.0|-13.54|-1.58|||ANCOVA|||Day 57±3||-1.58|-13.54|0.0134
73814177|NCT01887678|147178040|SUPERIORITY_OR_OTHER||Least Squares|-7.6||||0.0121|TWO_SIDED|95.0|-13.52|-1.68|||Least Squares|||Day 71±3||-1.68|-13.52|0.0121
73814178|NCT01887678|147178040|SUPERIORITY_OR_OTHER||Least Squares|-6.32||||0.0376|TWO_SIDED|95.0|-12.28|-0.37|||ANCOVA|||Day 85±3||-0.37|-12.28|0.0376
73814179|NCT01887678|147178041|SUPERIORITY_OR_OTHER||Least Squares|-4.76||||0.1373|TWO_SIDED|95.0|-11.05|1.53|||ANCOVA|||||1.53|-11.05|0.1373
73814180|NCT01887678|147178042|SUPERIORITY_OR_OTHER||Least Squares|-4.24||||0.1715|TWO_SIDED|95.0|-10.33|1.85|||ANCOVA|||||1.85|-10.33|0.1715
73814181|NCT01887678|147178043|SUPERIORITY_OR_OTHER||Least Squares|-4.77||||0.1211|TWO_SIDED|95.0|-10.82|1.27|||ANCOVA|||||1.27|-10.82|0.1211
73814182|NCT01887678|147178048|SUPERIORITY_OR_OTHER||Least Squares|-4.97||||0.1128|TWO_SIDED|95.0|-11.12|1.18|||ANCOVA|||Day 8±1||1.18|-11.12|0.1128
73814183|NCT01887678|147178048|SUPERIORITY_OR_OTHER||Least Squares|-10.49||||0.0013|TWO_SIDED|95.0|-16.85|-4.13|||ANCOVA|||Day 15±1||-4.13|-16.85|0.0013
73896427|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.99||||0.9602|TWO_SIDED|95.0|0.55|1.76||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.76|0.55|0.9602
73814184|NCT01887678|147178048|SUPERIORITY_OR_OTHER||Least Squares|-6.89||||0.0472|TWO_SIDED|95.0|-13.69|-0.09|||ANCOVA|||Day 29±3||-0.09|-13.69|0.0472
73814185|NCT01887678|147178048|SUPERIORITY_OR_OTHER||Least Squares|-8.82||||0.0109|TWO_SIDED|95.0|-15.6|-2.05|||ANCOVA|||Day 43±3||-2.05|-15.60|0.0109
73814186|NCT01887678|147178048|SUPERIORITY_OR_OTHER||Least Squares|-8.88||||0.0123|TWO_SIDED|95.0|-15.8|-1.95|||ANCOVA|||Day 57±3||-1.95|-15.80|0.0123
73814187|NCT01887678|147178048|SUPERIORITY_OR_OTHER||Least Squares|-6.88||||0.0425|TWO_SIDED|95.0|-13.52|-0.23|||ANCOVA|||Day 71±3||-0.23|-13.52|0.0425
73814188|NCT01887678|147178048|SUPERIORITY_OR_OTHER||Least Squares|-5.51||||0.1199|TWO_SIDED|95.0|-12.47|1.45|||ANCOVA|||Day 85±3||1.45|-12.47|0.1199
73814189|NCT01887678|147178048|SUPERIORITY_OR_OTHER||Least Squares|-4.96||||0.1575|TWO_SIDED|95.0|-11.86|1.93|||ANCOVA|||Day 119±3||1.93|-11.86|0.1575
73814190|NCT01887678|147178049|SUPERIORITY_OR_OTHER||Least Squares|-0.28||||0.6346|TWO_SIDED|95.0|-1.45|0.89|||ANCOVA|||Day 8±1||0.89|-1.45|0.6346
73814191|NCT01887678|147178049|SUPERIORITY_OR_OTHER||Least Squares|-0.28||||0.6458|TWO_SIDED|95.0|-1.49|0.92|||ANCOVA|||Day 15±1||0.92|-1.49|0.6458
73896428|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.62||||0.1254|TWO_SIDED|95.0|0.87|3.02||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||3.02|0.87|0.1254
73896429|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.13||||0.667|TWO_SIDED|95.0|0.65|1.99||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.99|0.65|0.6670
73896430|NCT00797966|147326202|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.7||||0.0525|TWO_SIDED|95.0|0.98|2.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.93|0.98|0.0525
73814192|NCT01887678|147178049|SUPERIORITY_OR_OTHER||Least Squares|-0.18||||0.7581|TWO_SIDED|95.0|-1.35|0.99|||ANCOVA|||Day 29±3||0.99|-1.35|0.7581
73814193|NCT01887678|147178049|SUPERIORITY_OR_OTHER||Least Squares|-0.49||||0.335|TWO_SIDED|95.0|-1.48|0.51|||ANCOVA|||Day 43±3||0.51|-1.48|0.3350
73814194|NCT01887678|147178049|SUPERIORITY_OR_OTHER||Least Squares|-0.4||||0.4419|TWO_SIDED|95.0|-1.44|0.63|||ANCOVA|||Day 57±3||0.63|-1.44|0.4419
73814195|NCT01887678|147178049|SUPERIORITY_OR_OTHER||Least Squares|-0.37||||0.446|TWO_SIDED|95.0|-1.32|0.58|||ANCOVA|||Day 71±3||0.58|-1.32|0.4460
73814196|NCT01887678|147178049|SUPERIORITY_OR_OTHER||Least Squares|0.25||||0.6552|TWO_SIDED|95.0|-0.84|1.33|||ANCOVA|||Day 85±3||1.33|-0.84|0.6552
73814197|NCT01887678|147178049|SUPERIORITY_OR_OTHER||Least Squares|-0.19||||0.7443|TWO_SIDED|95.0|-1.33|0.95|||ANCOVA|||Day 119±3||0.95|-1.33|0.7443
73814198|NCT01887678|147178054|SUPERIORITY_OR_OTHER|||||||0.2164|TWO_SIDED||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After first injection of study drug||||0.2164
73814199|NCT01887678|147178054|SUPERIORITY_OR_OTHER|||||||0.1651|TWO_SIDED|||||Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions|Log Rank|||After second injection of study drug||||0.1651
73814200|NCT01887678|147178054|SUPERIORITY_OR_OTHER|||||||0.222|TWO_SIDED||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After third injection of study drug||||0.2220
73814201|NCT01887678|147178055|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED||||||Log Rank|For equality of survival functions||After first injection of study drug||||0.0264
73814202|NCT01887678|147178055|SUPERIORITY_OR_OTHER|||||||0.0346|TWO_SIDED||||||Log Rank|For equality of survival functions||After second injection of study drug||||0.0346
73814203|NCT01887678|147178055|SUPERIORITY_OR_OTHER|||||||0.0172|TWO_SIDED||||||Log Rank|For equality of survival functions||After third injection of study drug||||0.0172
73814204|NCT00076999|147178077|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.02
73814205|NCT00076999|147178077|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.78
73814206|NCT00076999|147178078|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
73814207|NCT00076999|147178078|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
73814208|NCT00076999|147178079|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.12
73814209|NCT00076999|147178079|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
73814210|NCT00076999|147178080|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.12
73814211|NCT00076999|147178080|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
73814212|NCT00076999|147178081|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.01
73814213|NCT00076999|147178081|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
73814214|NCT00076999|147178082|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.06
73814215|NCT00076999|147178082|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
73814216|NCT00076999|147178083|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.60
73814217|NCT00076999|147178083|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
73814218|NCT00076999|147178084|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.20
73814219|NCT00076999|147178084|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
73814220|NCT00076999|147178085|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.18
73814221|NCT00076999|147178085|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
73814222|NCT00076999|147178087|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.02
73814223|NCT00076999|147178087|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.47
73814224|NCT00076999|147178088|SUPERIORITY_OR_OTHER|||||||0||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
73814225|NCT00076999|147178088|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.81
73814226|NCT00076999|147178089|SUPERIORITY_OR_OTHER|||||||0||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
73814227|NCT00076999|147178089|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.69
73814228|NCT00076999|147178091|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.64
73814229|NCT00076999|147178091|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.26
73814230|NCT00076999|147178092|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.25
73814231|NCT00076999|147178092|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.70
73814232|NCT00076999|147178093|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.73
73814233|NCT00076999|147178093|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.79
73814234|NCT00076999|147178095|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.38
73814235|NCT00076999|147178095|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.20
73814236|NCT00076999|147178096|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.08
73814237|NCT00076999|147178096|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.36
73814238|NCT00076999|147178097|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.23
73814239|NCT00076999|147178097|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.23
73814240|NCT04964986|147178105|SUPERIORITY|||||||0.041|||||||paired t-test|||||||0.041
73814241|NCT04964986|147178107|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 24||||<0.001
73814242|NCT04964986|147178107|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 52||||<0.001
73814243|NCT04964986|147178111|SUPERIORITY|||||||0.002|||||||paired t-test|||Week 24||||0.002
73814244|NCT04964986|147178111|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 52||||<0.001
73814245|NCT04964986|147178113|SUPERIORITY|||||||0.294|||||||paired t-test|||Fat absorption increase at Week 4||||0.294
73814246|NCT04964986|147178113|SUPERIORITY|||||||0.155|||||||paired t-test|||Fat absorption increase at Week 48||||0.155
73814247|NCT04964986|147178113|SUPERIORITY|||||||0.26|||||||paired t-test|||Carbohydrate absorption at Week 4||||0.260
73814248|NCT04964986|147178113|SUPERIORITY|||||||0.024|||||||paired t-test|||Carbohydrate absorption at Week 48||||0.024
73814249|NCT04964986|147178113|SUPERIORITY|||||||0.096|||||||paired t-test|||Protein absorption at Week 4||||0.096
73814250|NCT04964986|147178113|SUPERIORITY|||||||0.075|||||||paired t-test|||Protein absorption at Week 48||||0.075
73814251|NCT04964986|147178114|SUPERIORITY|||||||0.063|||||||paired t-test|||Week 4||||0.063
73814252|NCT04964986|147178114|SUPERIORITY|||||||0.112|||||||paired t-test|||Week 48||||0.112
73814253|NCT04964986|147178115|SUPERIORITY|||||||0.306|||||||paired t-test|||||||0.306
73814254|NCT04964986|147178116|SUPERIORITY||Median Difference (Final Values)|0.3346||||0.704|TWO_SIDED|95.0|-0.7887|0.8748|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Calcium, Week 4||0.8748|-0.7887|0.704
73814255|NCT04964986|147178116|SUPERIORITY||Median Difference (Final Values)|-0.104||||0.488|TWO_SIDED|95.0|-2.7442|0.8896|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Calcium, Week 48||0.8896|-2.7442|0.488
73814256|NCT04964986|147178116|SUPERIORITY||Median Difference (Final Values)|-0.219||||0.382|TWO_SIDED|95.0|-0.896|0.313|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Magnesium, Week 4||0.313|-0.896|0.382
73814257|NCT04964986|147178116|SUPERIORITY||Median Difference (Final Values)|-1.566||||0.059|TWO_SIDED|95.0|-5.279|-0.165|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Magnesium, Week 48||-0.165|-5.279|0.059
73814258|NCT04964986|147178116|SUPERIORITY||Median Difference (Final Values)|33.116||||0.004|TWO_SIDED|95.0|5.51|51.861|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Sodium, Week 4||51.861|5.510|0.004
73814259|NCT04964986|147178116|SUPERIORITY||Median Difference (Final Values)|20.727||||0.337|TWO_SIDED|95.0|-27.758|55.828|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Sodium, Week 48||55.828|-27.758|0.337
73814260|NCT04964986|147178116|SUPERIORITY||Median Difference (Final Values)|1.618||||0.724|TWO_SIDED|95.0|-11.87|14.931|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Potassium, Week 4||14.931|-11.870|0.724
73814261|NCT04964986|147178116|SUPERIORITY||Median Difference (Final Values)|-9.19||||0.115|TWO_SIDED|95.0|-18.88|3.737|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Potassium, Week 48||3.737|-18.880|0.115
73814262|NCT04964986|147178116|SUPERIORITY||Median Difference (Final Values)|12.297||||0.707|TWO_SIDED|95.0|-39.551|52.617|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Urea, Week 4||52.617|-39.551|0.707
73814263|NCT04964986|147178116|SUPERIORITY||Mean Difference (Final Values)|-91.487||||0.009|TWO_SIDED|95.0|-159.956|-20.068|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Urea, Week 48||-20.068|-159.956|0.009
73814264|NCT04964986|147178116|SUPERIORITY||Median Difference (Final Values)|0.281||||0.572|TWO_SIDED|95.0|-0.649|0.96|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Creatinine, Week 4||0.960|-0.649|0.572
73814265|NCT04964986|147178116|SUPERIORITY||Median Difference (Final Values)|-0.136||||0.981|TWO_SIDED|95.0|-1.06|1.073|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Creatinine, Week 48||1.073|-1.060|0.981
73814266|NCT04964986|147178117|SUPERIORITY|||||||0.066|||||||paired t-test|||Week 24||||0.066
73814267|NCT04964986|147178117|SUPERIORITY|||||||0.015|||||||paired t-test|||Week 52||||0.015
73814268|NCT05821296|147178124|OTHER|Change of sum of total lesions at the end of the study from baseline/Day 0 to evaluate the efficacy and clinical performance of Crystal Peel for the treatment of acne.|Mean Difference (Final Values)|-14.58|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-17.31|-11.84|||ANCOVA|||||-11.84|-17.31|<0.0001
73814269|NCT05821296|147178125|OTHER||Mean Difference (Final Values)|1.85|STANDARD_DEVIATION|0.87|||TWO_SIDED|95.0|1.54|2.16||||||||2.16|1.54|
73814270|NCT05821296|147178126|OTHER||Mean Difference (Final Values)|1.82|STANDARD_DEVIATION|1.07|||TWO_SIDED|95.0|1.44|2.2||||||||2.20|1.44|
73814271|NCT05821296|147178127|OTHER||Mean value in local tolerance score|2.21|STANDARD_DEVIATION|0.65|||TWO_SIDED|95.0|1.98|2.44||||||||2.44|1.98|
73814272|NCT05821296|147178128|OTHER|Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.|% of patients with positive answers|79.0|||||TWO_SIDED|95.0|61.0|89.0||||||||89|61|
73814273|NCT05821296|147178128|OTHER||% of patients with positive answers|94.0|||||TWO_SIDED|95.0|80.0|98.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||98|80|
73814274|NCT05821296|147178128|OTHER||% of patients with positive answers|88.0|||||TWO_SIDED|95.0|73.0|95.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||95|73|
73814275|NCT05821296|147178128|OTHER||% of patients with positive answers|85.0|||||TWO_SIDED|95.0|68.0|93.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||93|68|
73814276|NCT05821296|147178128|OTHER||% of patients with positive answers|91.0|||||TWO_SIDED|95.0|77.0|97.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||97|77|
73814277|NCT05821296|147178128|OTHER||% of patients with positive answers|85.0|||||TWO_SIDED|95.0|69.0|93.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||93|69|
73814278|NCT05821296|147178128|OTHER||% of patients with positive answers|78.0|||||TWO_SIDED|95.0|61.0|89.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||89|61|
73814279|NCT05821296|147178128|OTHER||% of patients with positive answers|79.0|||||TWO_SIDED|95.0|62.0|89.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||89|62|
73814280|NCT05821296|147178128|OTHER||% of patients with positive answers|76.0|||||TWO_SIDED|95.0|59.0|87.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||87|59|
73814281|NCT05821296|147178130|OTHER||Mean Difference (Net)|-47.24|STANDARD_DEVIATION|56.61|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.||||< 0.0001
73814282|NCT05821296|147178130|OTHER||Mean Difference (Final Values)|-30.85|STANDARD_DEVIATION|63.92||0.01|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.010
73896431|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.98||||0.9462|TWO_SIDED|95.0|0.52|1.84||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.84|0.52|0.9462
73814283|NCT05821296|147178130|OTHER||Mean Difference (Final Values)|-41.69|STANDARD_DEVIATION|73.69|<|0.004|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||<0.004
73814284|NCT05821296|147178130|OTHER||Mean Difference (Final Values)|-29.13|STANDARD_DEVIATION|61.45||0.013|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.013
73814285|NCT05821296|147178131|OTHER||Mean Difference (Final Values)|-2832.39|STANDARD_DEVIATION|3217.15|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.||||< 0.0001
73814286|NCT05821296|147178131|OTHER||Mean Difference (Final Values)|-1754.88|STANDARD_DEVIATION|4220.25||0.025|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.025
73814287|NCT05821296|147178131|OTHER||Mean Difference (Final Values)|-2763.41|STANDARD_DEVIATION|4965.84||0.004|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.004
73814288|NCT05821296|147178131|OTHER||Mean Difference (Final Values)|-1742.41|STANDARD_DEVIATION|3974.21||0.021|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.021
73814289|NCT05821296|147178132|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|1.3|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||<0.0001
73814290|NCT05821296|147178132|OTHER||Mean Difference (Final Values)|-0.68|STANDARD_DEVIATION|1.68||0.029|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.029
73814291|NCT05821296|147178132|OTHER||Mean Difference (Final Values)|-1.07|STANDARD_DEVIATION|2.01||0.006|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.006
73814292|NCT05821296|147178132|OTHER||Mean Difference (Net)|-0.65|STANDARD_DEVIATION|1.67||0.037|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.037
73814293|NCT05821296|147178133|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_DEVIATION|0.58||0.001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||0.001
73814294|NCT05821296|147178133|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_DEVIATION|0.71||0.348|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.348
73814295|NCT05821296|147178133|OTHER||Mean Difference (Final Values)|-0.27|STANDARD_DEVIATION|0.75||0.091|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.091
73814296|NCT05821296|147178133|OTHER||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.65||0.19|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.190
73814297|NCT05821296|147178134|OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|3.55||0.011|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||0.011
73896432|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.8||||0.4971|TWO_SIDED|95.0|0.43|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.49|0.43|0.4971
73896433|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.93||||0.8118|TWO_SIDED|95.0|0.53|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.63|0.53|0.8118
73896434|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.95||||0.8323|TWO_SIDED|95.0|0.59|1.53||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.53|0.59|0.8323
73896435|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.68||||0.093|TWO_SIDED|95.0|0.43|1.08||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.08|0.43|0.0930
73814298|NCT05821296|147178134|OTHER||Mean Difference (Final Values)|-0.64|STANDARD_DEVIATION|3.28||0.281|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.281
73814299|NCT05821296|147178134|OTHER||Mean Difference (Final Values)|-1.57|STANDARD_DEVIATION|4.46||0.06|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.060
73814300|NCT05821296|147178134|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_DEVIATION|3.8||0.209|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.209
73814301|NCT05821296|147178135|OTHER||Mean Difference (Final Values)|-26495.83|STANDARD_DEVIATION|33223.6|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||<0.0001
73814302|NCT05821296|147178135|OTHER||Mean Difference (Final Values)|-14447.02|STANDARD_DEVIATION|44054.48||0.073|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.073
73814303|NCT05821296|147178135|OTHER|If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Mean Difference (Final Values)|-25315.34|STANDARD_DEVIATION|49884.67||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.008
73814304|NCT05821296|147178135|OTHER||Mean Difference (Final Values)|-13287.34|STANDARD_DEVIATION|39615.92||0.071|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.071
73814305|NCT05821296|147178136|OTHER||Mean Difference (Final Values)|-7518.25|STANDARD_DEVIATION|13340.45||0.003|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.003
73814306|NCT05821296|147178136|OTHER||Mean Difference (Final Values)|-7230.81|STANDARD_DEVIATION|17547.6||0.041|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.041
73814307|NCT05821296|147178136|OTHER||Mean Difference (Final Values)|-9086.26|STANDARD_DEVIATION|18306.64||0.007|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.007
73814308|NCT05821296|147178136|OTHER||Mean Difference (Final Values)|64.71|STANDARD_DEVIATION|14542.17||0.931|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.931
73814309|NCT05821296|147178137|OTHER||Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|0.66||0.005|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.005
73814310|NCT05821296|147178137|OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.8||0.035|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.035
73814311|NCT05821296|147178137|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_DEVIATION|0.86||0.036|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.036
73814312|NCT05821296|147178137|OTHER||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.77||0.784|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.784
73814313|NCT05821296|147178138|OTHER||Mean Difference (Final Values)|-2249.72|STANDARD_DEVIATION|4466.14||0.011|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.||Comparison of change from baseline of conspicuous length of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.011
73896436|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.88||||0.553|TWO_SIDED|95.0|0.59|1.32||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.32|0.59|0.5530
73896437|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.8007|TWO_SIDED|95.0|0.69|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.61|0.69|0.8007
73896438|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.03||||0.8945|TWO_SIDED|95.0|0.71|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.49|0.71|0.8945
73814314|NCT05821296|147178138|OTHER||Mean Difference (Final Values)|-2315.0|STANDARD_DEVIATION|6197.86||0.074|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.074
73814315|NCT05821296|147178138|OTHER||Mean Difference (Final Values)|-2700.55|STANDARD_DEVIATION|5962.3||0.007|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.007
73814316|NCT05821296|147178138|OTHER||Mean Difference (Final Values)|430.65|STANDARD_DEVIATION|5021.2||0.779|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.779
73814317|NCT05821296|147178139|OTHER||Mean Difference (Final Values)|-75800.75|STANDARD_DEVIATION|142643.92||0.003|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.003
73814318|NCT05821296|147178139|OTHER||Mean Difference (Final Values)|-73517.86|STANDARD_DEVIATION|197224.85||0.054|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.054
73814319|NCT05821296|147178139|OTHER||Mean Difference (Final Values)|-90424.89|STANDARD_DEVIATION|198264.2||0.008|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.008
73814320|NCT05821296|147178139|OTHER||Mean Difference (Final Values)|1314.03||||0.779|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.779
73814321|NCT00497770|147178163|NON_INFERIORITY_OR_EQUIVALENCE|A pre-specified logistic regression was used to assess non-inferiority of DCR in African American participants compared with Caucasian participants. The DCR for African Americans was to be considered non-inferior to the DCR for Caucasians if the upper bound of the confidence interval (CI) of the odds ratio (OR) for African American versus Caucasian was \<1.78 which corresponds to a difference in proportions of approximately 14% assuming the DCR in the reference group to be 50%.|Odds Ratio (OR)|0.821|||||TWO_SIDED|95.0|0.427|1.58||Adjusted:baseline characteristics, income, marital/insurance status, comorbid, time between end of 1st line therapy and start of pemetrexed, prior platinum- or Paclitaxel-containing regimen, number of cycles and best response during 1st line therapy.|Regression, Logistic|||||1.580|0.427|
73814322|NCT00678470|147178183|OTHER||Correlation|1.0||||0.0003|TWO_SIDED||||||Fisher Exact||||Using Fisher's non-parametric test of associations, correlations were determined between the patients who were intralesional responders with their response at ‡70% change in PASI score.|||0.0003
73814323|NCT01782352|147178211|SUPERIORITY||Hazard Ratio (HR)|1.02|||<|0.05|TWO_SIDED|95.0|0.82|1.27|||Regression, Cox|||||1.27|0.82|<0.05
73814324|NCT01782352|147178211|SUPERIORITY||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.76|1.17|||Regression, Cox|||||1.17|0.76|<0.05
73814325|NCT01782352|147178212|SUPERIORITY||Hazard Ratio (HR)|1.21|||<|0.05|TWO_SIDED|95.0|0.86|1.7|||Regression, Cox|||||1.70|0.86|<0.05
73814326|NCT01782352|147178212|SUPERIORITY||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.59|1.17|||Regression, Cox|||||1.17|0.59|<0.05
73814327|NCT01782352|147178213|SUPERIORITY||Hazard Ratio (HR)|1.23|||<|0.05|TWO_SIDED|95.0|0.81|1.84|||Regression, Cox|||||1.84|0.81|<0.05
73814328|NCT01782352|147178213|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.05|TWO_SIDED|95.0|0.48|1.09|||Regression, Cox|||||1.09|0.48|<0.05
73814329|NCT01782352|147178214|SUPERIORITY||Hazard Ratio (HR)|1.09|||<|0.05|TWO_SIDED|95.0|0.86|1.37|||Regression, Cox|||||1.37|0.86|<0.05
73814330|NCT01782352|147178214|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.73|1.17|||Regression, Cox|||||1.17|0.73|<0.05
73814331|NCT01782352|147178215|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.05|TWO_SIDED|95.0|0.33|1.21|||Regression, Cox|||||1.21|0.33|<0.05
73814332|NCT01782352|147178215|SUPERIORITY||Hazard Ratio (HR)|1.05|||<|0.05|TWO_SIDED|95.0|0.56|1.97|||Regression, Cox|||||1.97|0.56|<0.05
73814333|NCT01782352|147178216|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.69|1.25|||Regression, Cox|||||1.25|0.69|<0.05
73814334|NCT01782352|147178216|SUPERIORITY||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.67|1.21|||Regression, Cox|||||1.21|0.67|<0.05
73814335|NCT01953432|147178217|OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED||||||||Probability of 0.75 that the OR exceeded 1.00 (OR = 1.01, 95% CI = 0.98-1.05)|||||
73814336|NCT01953432|147178217|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED||||||||Probability of 0.96 that the odds ratio exceeded 1.00 (OR = 1.03, 95% CI = 1.00-1.07)|||||
73814337|NCT00232596|147178218|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||<0.001
73814338|NCT00232596|147178219|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73814339|NCT01554176|147178269|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.7||||0.679|TWO_SIDED|95.0|-3.8|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Number of participants included for calculation of mean ± SD baseline and mean ± SD change from baseline MADRS Total Score is 119. Constrained longitudinal data analysis (cLDA) model uses efficacy Full Analysis Set (FAS) population (number of participants: filorexant 10 mg - 64, placebo - 64; total number of participants in cLDA analysis - 128).||2.5|-3.8|0.679
73814340|NCT01554176|147178270|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.3||||0.82|TWO_SIDED|95.0|-3.2|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||2.5|-3.2|0.820
73814341|NCT01554176|147178271|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.3||||0.701|TWO_SIDED|95.0|-1.9|1.3||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||1.3|-1.9|0.701
73814342|NCT01554176|147178272|SUPERIORITY_OR_OTHER||Estimated Odds Ratio|2.5||||0.0965|TWO_SIDED|95.0|0.8|7.3||Generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction.|Generalized Linear Mixed Effects Model|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||7.3|0.8|0.0965
73814343|NCT01554176|147178273|SUPERIORITY_OR_OTHER||Difference in percentage incidence|15.6|||||TWO_SIDED|95.0|-0.9|31.4||||Between-group comparison of AE incident rate||Estimated parameter is between-group difference in percentage of participants with an AE = percentage (filorexant 10 mg) - percentage (placebo) for participants with one or more AE.||31.4|-0.9|
73814344|NCT01554176|147178274|SUPERIORITY_OR_OTHER||Difference in percentage incidence|0.0|||||TWO_SIDED|95.0|-7.0|7.0||||Between-group comparison of incidence rate of drug discontinuation due to AE||Estimated parameter is between-group difference in percentage of participants discontinued from study drug due to an AE = percentage (filorexant 10 mg) - percentage (placebo).||7|-7|
73814345|NCT00386425|147178277|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||p-value is for change to Day 7|t-test, 2 sided|||||||0.011
73814346|NCT00386425|147178278|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||p-value is for the moderate Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided|||||||0.047
73814347|NCT00386425|147178278|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||p-value is for the severe Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided|||||||0.063
73814348|NCT00386425|147178279|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||p-value is for Day 28 mortality|Fisher Exact|||||||0.030
73814349|NCT00386425|147178280|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||p-value is for Day 90 mortality|Fisher Exact|||||||0.090
73814350|NCT00386425|147178281|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||p-value is for total SOFA difference between alternative and standard therapy|t-test, 2 sided|||||||0.190
73814351|NCT00386425|147178281|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||p-value is for difference in cardiovascular SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.268
73814352|NCT00386425|147178281|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||p-value is for difference in respiratory SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.082
73814353|NCT00386425|147178281|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||p-value is for difference in renal SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.367
73814354|NCT00386425|147178281|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||p-value is for difference in hematology SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.274
73814355|NCT00386425|147178281|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||p-value is for difference in liver SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.341
73814356|NCT00386425|147178283|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for difference between participants normalizing protein C and not normalizing protein C.|Fisher Exact|||||||<0.0001
73814357|NCT00386425|147178284|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||p-value is for 28-Day Mortality, Dead at Day 28 vs. Alive at Day 28|Pearson's chi-square test|||||||0.622
73814358|NCT00386425|147178284|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value is for Hospital Mortality|Fisher Exact|||||||0.815
73814359|NCT03053427|147178286|SUPERIORITY||LSM difference|-1.2|STANDARD_ERROR_OF_MEAN|0.7||0.088|TWO_SIDED|95.0|-2.6|0.2|||Mixed Model of Repeated Measurements|||MMRM with compound symmetry as the covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.||0.2|-2.6|0.088
73814360|NCT03053427|147178287|SUPERIORITY||LSM difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.051|TWO_SIDED|95.0|-2.2|0.0|||ANCOVA|Time frame: week 1||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.0|-2.2|0.051
73814361|NCT03053427|147178287|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.02|TWO_SIDED|95.0|-2.8|-0.2|||ANCOVA|Time frame: week 2||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-2.8|0.020
73814362|NCT03053427|147178287|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.028|TWO_SIDED|95.0|-2.9|-0.2|||ANCOVA|Time frame: week 4||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-2.9|0.028
73814363|NCT03053427|147178287|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.043|TWO_SIDED|95.0|-2.9|0.0|||ANCOVA|Time frame: week 6||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.0|-2.9|0.043
73814364|NCT03053427|147178287|SUPERIORITY||LSM difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.184|TWO_SIDED|95.0|-2.4|0.5|||ANCOVA|Time frame: week 8||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.5|-2.4|0.184
73814365|NCT03053427|147178287|SUPERIORITY||LSM difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.027|TWO_SIDED|95.0|-3.1|-0.2|||ANCOVA|Time frame: week 10||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-3.1|0.027
73814366|NCT03053427|147178287|SUPERIORITY||LSM difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.087|TWO_SIDED|95.0|-3.0|0.2|||ANCOVA|Time frame: week 12||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.2|-3.0|0.087
73814367|NCT03053427|147178287|SUPERIORITY||LSM difference|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.312|TWO_SIDED|95.0|-2.4|0.8|||ANCOVA|Time frame: EoT||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.8|-2.4|0.312
73814368|NCT03053427|147178288|SUPERIORITY||difference|4.2||||0.467|TWO_SIDED|95.0|-6.4|14.8|||Fisher Exact|||||14.8|-6.4|0.467
73814369|NCT03053427|147178289|SUPERIORITY||difference|5.8||||0.3|TWO_SIDED|95.0|-4.8|16.5|||Fisher Exact|||||16.5|-4.8|0.300
73814370|NCT03053427|147178290|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.877|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in PSQI component and global scores from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.5|-0.5|0.877
73814371|NCT03053427|147178291|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.975|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in total score of Athens insomnia scale from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.7|-0.7|0.975
73814372|NCT03053427|147178292|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.838|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in RLS pain score from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.3|-0.4|0.838
73814373|NCT02172040|147178298|NON_INFERIORITY|Non-inferiority margin definition: lower limit of the 95% confidence interval (CI) for amlodipine + celecoxib arm did not cross the 50% value for the amlodipine arm.|||||=|0.001|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The primary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with amlodipine + celecoxib was non-inferior to half of the effect achieved with amlodipine.||||= 0.001
73896439|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.17||||0.3837|TWO_SIDED|95.0|0.83|1.64||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.64|0.83|0.3837
73814374|NCT02172040|147178298|SUPERIORITY||||||=|0.491|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The secondary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with placebo was superior to treatment with celecoxib. This was only to be performed if statistical significance was achieved for the primary comparison.||||= 0.491
73814375|NCT02172040|147178299|OTHER||||||=|0.166|||||||Chi-squared|||||||= 0.166
73814376|NCT02172040|147178300|SUPERIORITY|||||||0.177|||||||t-test, 1 sided|||||||0.177
73814377|NCT02172040|147178300|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814378|NCT02172040|147178300|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814379|NCT02172040|147178300|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814380|NCT02172040|147178300|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814381|NCT02172040|147178300|SUPERIORITY||||||=|0.719|||||||t-test, 1 sided|||||||= 0.719
73814382|NCT02172040|147178301|SUPERIORITY||||||=|0.069|||||||t-test, 1 sided|||||||= 0.069
73896440|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.09||||0.7064|TWO_SIDED|95.0|0.72|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.63|0.72|0.7064
73896441|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.7469|TWO_SIDED|95.0|0.74|1.52||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.52|0.74|0.7469
73814383|NCT02172040|147178301|SUPERIORITY||||||=|0.001|||||||t-test, 1 sided|||||||= 0.001
73814384|NCT02172040|147178301|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814385|NCT02172040|147178301|SUPERIORITY||||||=|0.097|||||||t-test, 1 sided|||||||= 0.097
73814386|NCT02172040|147178301|SUPERIORITY||||||=|0.064|||||||t-test, 1 sided|||||||= 0.064
73814387|NCT02172040|147178301|SUPERIORITY||||||=|0.924|||||||t-test, 1 sided|||||||= 0.924
73814388|NCT02172040|147178302|SUPERIORITY||||||=|0.038|||||||t-test, 1 sided|||||||= 0.038
73814389|NCT02172040|147178302|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814390|NCT02172040|147178302|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814391|NCT02172040|147178302|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814392|NCT02172040|147178302|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814393|NCT02172040|147178302|SUPERIORITY||||||=|0.562|||||||t-test, 1 sided|||||||= 0.562
73814394|NCT02172040|147178303|SUPERIORITY||||||=|0.104|||||||t-test, 1 sided|||||||= 0.104
73814395|NCT02172040|147178303|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814396|NCT02172040|147178303|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814397|NCT02172040|147178303|SUPERIORITY||||||=|0.002|||||||t-test, 1 sided|||||||= 0.002
73814398|NCT02172040|147178303|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814399|NCT02172040|147178303|SUPERIORITY||||||=|0.419|||||||t-test, 1 sided|||||||= 0.419
73814400|NCT02172040|147178304|SUPERIORITY||||||=|0.028|||||||t-test, 1 sided|||||||= 0.028
73814401|NCT02172040|147178304|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814402|NCT02172040|147178304|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814403|NCT02172040|147178304|SUPERIORITY||||||=|0.051|||||||t-test, 1 sided|||||||= 0.051
73814404|NCT02172040|147178304|SUPERIORITY||||||=|0.074|||||||t-test, 1 sided|||||||= 0.074
73814405|NCT02172040|147178304|SUPERIORITY||||||=|0.878|||||||t-test, 1 sided|||||||= 0.878
73896442|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.34||||0.0832|TWO_SIDED|95.0|0.97|1.86||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.86|0.97|0.0832
73896443|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.09||||0.6611|TWO_SIDED|95.0|0.74|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.61|0.74|0.6611
73814406|NCT02172040|147178305|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814407|NCT02172040|147178306|OTHER||||||=|0.977|||||||t-test, 1 sided|||||||= 0.977
73814408|NCT02172040|147178307|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814409|NCT02172040|147178308|OTHER||||||=|0.527|||||||t-test, 1 sided|||||||= 0.527
73814410|NCT02172040|147178309|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814411|NCT02172040|147178309|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814412|NCT02172040|147178309|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73814413|NCT02172040|147178309|SUPERIORITY||||||=|0.001|||||||t-test, 1 sided|||||||= 0.001
73814414|NCT03816644|147178310|SUPERIORITY||Odds Ratio (OR)|3.43|||||TWO_SIDED|95.0|2.32|5.07||||||The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in dementia care outcomes between the intervention and control groups at 90 days post screening visit. Models are adjusted for age, sex, and years of education.||5.07|2.32|
73814415|NCT03816644|147178311|SUPERIORITY||Odds Ratio (OR)|1.133|||||TWO_SIDED|95.0|0.837|1.534||||||The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in participants who were hospitalized or visited an ER 6 months post screening visit.||1.534|0.837|
73814416|NCT01801241|147178318|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
73814417|NCT03240406|147178365|SUPERIORITY||Mean Difference (Net)|-0.06||||0.259|TWO_SIDED|95.0|-0.15|0.04||Test of the between arm difference in the global composite at Burst 2, adjusted for the study arm, baseline (Burst 1) global composite, and the randomization stratification factors (baseline sex, age, and years of education)|ANCOVA|ANCOVA of Burst 2 composite adjusted for arm, Burst 1 composite, sex, age, and education. Missing/invalid data were multiply imputed using MICE|Mean Difference of MHD Arm compared to control|||0.04|-0.15|0.259
73814418|NCT03240406|147178366|SUPERIORITY||Mean Difference (Net)|-0.64||||0.001|TWO_SIDED|95.0|-1.02|-0.27||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||-0.27|-1.02|0.001
73814419|NCT03240406|147178367|SUPERIORITY||Mean Difference (Net)|-0.94|||<|0.001|TWO_SIDED|95.0|-1.34|-0.54||Estimated from ANCOVA model adjusted for baseline value, age, sex, and years of education at baseline.|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education.|Mean Difference of MHD Arm vs Comparison Arm|||-0.54|-1.34|<0.001
73814420|NCT03240406|147178368|SUPERIORITY||Mean Difference (Net)|0.24||||0.904|TWO_SIDED|95.0|-3.63|4.11||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||4.11|-3.63|0.904
73814421|NCT03240406|147178369|SUPERIORITY||Mean Difference (Net)|-0.12||||0.721|TWO_SIDED|95.0|-0.76|0.52||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, and education; tocopherol biomarker values additionally adjusted for Burst 1 and Burst 2 levels of HDL, LDL, and triglycerides|ANCOVA|Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education; Burst 1 and Burst 2 levels of HDL, LDL and triglycerides|Mean Difference of MHD Arm vs Comparison Arm|||0.52|-0.76|0.721
73814422|NCT03240406|147178370|SUPERIORITY||Mean Difference (Net)|0.0||||0.769|TWO_SIDED|95.0|-0.01|0.01||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, and education; carotenoid biomarker values additionally adjusted for Burst 1 and Burst 2 levels of HDL, LDL, and triglycerides|ANCOVA|Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education; Burst 1 and Burst 2 levels of HDL, LDL and triglycerides|Mean Difference of MHD Arm vs Comparison Arm|||0.01|-0.01|0.769
73814423|NCT03240406|147178371|SUPERIORITY||Mean Difference (Net)|-1.37||||0.978|TWO_SIDED|95.0|-100.13|97.4||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||97.4|-100.13|0.978
73814424|NCT03240406|147178372|SUPERIORITY||Mean Difference (Net)|0.15||||0.395|TWO_SIDED|95.0|-0.2|0.51||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for Monounsaturated Fat||0.51|-0.2|0.395
73814425|NCT03240406|147178372|SUPERIORITY||Mean Difference (Net)|-0.11||||0.019|TWO_SIDED|95.0|-0.21|-0.02||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for Long Chain Saturated Fat||-0.02|-0.21|0.019
73896444|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.13||||0.4435|TWO_SIDED|95.0|0.83|1.56||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.56|0.83|0.4435
73896445|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.47||||0.0118|TWO_SIDED|95.0|1.09|1.98||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.98|1.09|0.0118
73896446|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.89||||0.5111|TWO_SIDED|95.0|0.63|1.26||Cochran-Mantel-Haenszel general association test controlling for study center.|Chi-squared, Corrected|||Week 14 values presented here.||1.26|0.63|0.5111
73896447|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.9||||0.4903|TWO_SIDED|95.0|0.66|1.22||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.22|0.66|0.4903
73896448|NCT00797966|147326203|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.28||||0.0662|TWO_SIDED|95.0|0.98|1.67||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.67|0.98|0.0662
73814426|NCT03240406|147178372|SUPERIORITY||Mean Difference (Net)|0.12||||0.201|TWO_SIDED|95.0|-0.07|0.31||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for EPA||0.31|-0.07|0.201
73814427|NCT03240406|147178372|SUPERIORITY||Mean Difference (Net)|0.27||||0.039|TWO_SIDED|95.0|0.01|0.53||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for DHA||0.53|0.01|0.039
73814428|NCT03240406|147178372|SUPERIORITY||Mean Difference (Net)|-0.01||||0.619|TWO_SIDED|95.0|-0.06|0.03||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean difference of MHD Arm vs Comparison Arm|Statistical Analysis results for n3 DPA||0.03|-0.06|0.619
73814429|NCT03240406|147178373|SUPERIORITY||Mean Difference (Net)|0.18||||0.521|TWO_SIDED|95.0|-0.37|0.73||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.73|-0.37|0.521
73814430|NCT03240406|147178374|SUPERIORITY||Mean Difference (Net)|145.0||||0.101|TWO_SIDED|95.0|-27.7|317.6||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||317.6|-27.7|0.101
73814431|NCT03240406|147178375|SUPERIORITY||Mean Difference (Net)|-24.63||||0.645|TWO_SIDED|95.0|-129.16|79.89||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||79.89|-129.16|0.645
73814432|NCT03240406|147178376|SUPERIORITY||Mean Difference (Net)|3.26||||0.245|TWO_SIDED|95.0|-2.23|8.75||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||8.75|-2.23|0.245
73814433|NCT03240406|147178377|SUPERIORITY||Mean Difference (Net)|0.21||||0.032|TWO_SIDED|95.0|0.02|0.4||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.4|0.02|0.032
73814434|NCT03240406|147178378|SUPERIORITY||Mean Difference (Net)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.26|0.08|<0.001
73814435|NCT03240406|147178379|SUPERIORITY||Mean Difference (Net)|-1.36||||0.635|TWO_SIDED|95.0|-6.95|4.24||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||4.24|-6.95|0.635
73814436|NCT03240406|147178380|SUPERIORITY||Mean Difference (Net)|-3.52||||0.019|TWO_SIDED|95.0|-6.44|0.59||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.59|-6.44|0.019
73814437|NCT03240406|147178381|SUPERIORITY||Mean Difference (Net)|-3.13||||0.639|TWO_SIDED|95.0|-16.18|9.92||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||9.92|-16.18|0.639
73814438|NCT03240406|147178382|SUPERIORITY||Mean Difference (Net)|41.71|||<|0.001|TWO_SIDED|95.0|21.47|61.96||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||61.96|21.47|<0.001
73814439|NCT03240406|147178383|SUPERIORITY||Mean Difference (Net)|-15.37||||0.115|TWO_SIDED|95.0|-34.44|3.69||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||3.69|-34.44|0.115
73814440|NCT03240406|147178384|SUPERIORITY||Mean Difference (Net)|0.06||||0.847|TWO_SIDED|95.0|-0.53|0.64||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.64|-0.53|0.847
73814441|NCT03240406|147178385|SUPERIORITY||Mean Difference (Net)|118.57||||0.191|TWO_SIDED|95.0|-58.62|295.76||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||295.76|-58.62|0.191
73814442|NCT03240406|147178386|SUPERIORITY||Mean Difference (Net)|955.19||||0.019|TWO_SIDED|95.0|164.63|1745.74||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1745.74|164.63|0.019
73814443|NCT03240406|147178387|SUPERIORITY||Mean Difference (Net)|-15.74||||0.493|TWO_SIDED|95.0|-60.66|29.19||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||29.19|-60.66|0.493
73814444|NCT03240406|147178388|SUPERIORITY||Mean Difference (Net)|14.83||||0.18|TWO_SIDED|95.0|-6.78|36.45||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||36.45|-6.78|0.18
73814445|NCT03240406|147178389|SUPERIORITY||Mean Difference (Net)|436.14||||0.379|TWO_SIDED|95.0|-534.05|1406.33||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1406.33|-534.05|0.379
73814446|NCT03240406|147178390|SUPERIORITY||Mean Difference (Net)|784.06||||0.083|TWO_SIDED|95.0|-99.73|1667.85||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1667.85|-99.73|0.083
73814447|NCT03240406|147178391|SUPERIORITY||Mean Difference (Net)|1.33||||0.011|TWO_SIDED|95.0|0.32|2.35||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||2.35|0.32|0.011
73814448|NCT03240406|147178392|SUPERIORITY||Mean Difference (Net)|0.07||||0.541|TWO_SIDED|95.0|-0.16|0.31||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.31|-0.16|0.541
73814449|NCT03240406|147178393|SUPERIORITY||Mean Difference (Net)|0.01||||0.273|TWO_SIDED|95.0|-0.01|0.03||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.03|-0.01|0.273
73814450|NCT03240406|147178394|SUPERIORITY||Mean Difference (Net)|0.03||||0.116|TWO_SIDED|95.0|-0.01|0.06||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.06|-0.01|0.116
73814451|NCT03240406|147178395|SUPERIORITY||Mean Difference (Net)|0.0||||0.213|TWO_SIDED|95.0|0.0|0.01||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.01|0|0.213
73814452|NCT03240406|147178396|SUPERIORITY||Mean Difference (Net)|0.05||||0.036|TWO_SIDED|95.0|0.0|0.09||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.09|0|0.036
73814453|NCT03240406|147178397|SUPERIORITY||Mean Difference (Net)|0.17||||0.223|TWO_SIDED|95.0|-0.1|0.43||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.43|-0.1|0.223
73814454|NCT03240406|147178398|SUPERIORITY||Mean Difference (Net)|-0.17||||0.119|TWO_SIDED|95.0|-0.38|0.04||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.04|-0.38|0.119
73814455|NCT03240406|147178399|SUPERIORITY||Mean Difference (Net)|-0.04||||0.841|TWO_SIDED|95.0|-0.41|0.33||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.33|-0.41|0.841
73814456|NCT03240406|147178400|SUPERIORITY||Mean Difference (Net)|0.25||||0.088|TWO_SIDED|95.0|-0.04|0.53||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.53|-0.04|0.088
73814457|NCT03240406|147178401|SUPERIORITY||Mean Difference (Net)|-0.01||||0.893|TWO_SIDED|95.0|-0.13|0.11||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.11|-0.13|0.893
73814458|NCT03240406|147178402|SUPERIORITY||Mean Difference (Net)|-1.43||||0.042|TWO_SIDED|95.0|-2.81|-0.06||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||-0.06|-2.81|0.042
73814459|NCT03240406|147178403|SUPERIORITY||Slope|-16.0||||0.031|TWO_SIDED|95.0|-31.0|-1.5||Linear mixed-effects model adjusted for adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Mixed Models Analysis|Adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Difference in the slopes of processing speed over years between MHD Arm and Comparison Arm.|||-1.5|-31|0.031
73814460|NCT03240406|147178404|SUPERIORITY||Slope|0.12||||0.55|TWO_SIDED|95.0|-0.27|0.51||Linear mixed-effects model adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Mixed Models Analysis|Adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Difference in the slopes of error distance over years between MHD Arm vs Comparison Arm|||0.51|-0.27|0.55
73814461|NCT03240406|147178405|SUPERIORITY||Slope|-0.018||||0.846|TWO_SIDED|95.0|-0.09|0.054||Generalized Estimating equation Poisson model adjusted for arm, year, weekday vs weekend, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), time of day (cubic spline)|Generalized Estimating Equation|Adjusted for arm, year, wkday/wknd, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), time of day (cubic spline)|Difference in the slopes of log-transformed error rates over years between the MHD Arm and the Comparison Arm.|||0.054|-0.090|0.846
73814462|NCT02607306|147178406|NON_INFERIORITY|Non-inferiority of IDegLira vs. IDeg was confirmed if the 95% confidence interval for the mean treatment difference lies entirely below 0.3%.|Treatment contrast|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.52||p-value for non-inferiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.||-0.52|-0.75|<0.0001
73814463|NCT02607306|147178406|SUPERIORITY|Superiority of IDegLira vs. Lira was confirmed if the 95% confidence interval for the mean treatment difference for change from baseline in HbA1c lies entirely below 0.0%.|Treatment contrast|-0.48|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.37||p-value for superiority of IDegLira vs Lira is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.||-0.37|-0.60|<0.0001
73814464|NCT02607306|147178407|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-1.19||||0.0001|TWO_SIDED|95.0|-1.8|-0.59||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks were analysed using an ANCOVA method with treatment and pre-trial OAD treatment as fixed factors and baseline body weight as covariate.||-0.59|-1.80|0.0001
73814465|NCT02607306|147178408|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|0.48|||<|0.0001|TWO_SIDED|95.0|0.35|0.68||p-value for superiority of IDegLira vs IDeg is presented|Negative binomial regression|||The number of events is analysed using a negative binomial regression model (log link) with the logarithm of the treatment emergent exposure time (100 years) as offset. The model includes treatment and pre-trial OAD treatment as fixed factors.||0.68|0.35|<0.0001
73896449|NCT00913458|147326219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.8|||<|0.0001|TWO_SIDED|95.0|2.7|12.5||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||12.5|2.7|<0.0001
73896450|NCT00913458|147326219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.0085|TWO_SIDED|95.0|1.3|5.3||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.3|1.3|0.0085
73896451|NCT00913458|147326219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0397|TWO_SIDED|95.0|1.0|4.8||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Linear|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.8|1.0|0.0397
73896452|NCT00913458|147326220|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~End of Phase 1"||||<0.0001
73896453|NCT00913458|147326221|SUPERIORITY_OR_OTHER|||||||0.1183|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 52"||||0.1183
73814466|NCT02607306|147178409|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.52||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment, pre-trial OAD as fixed factors and corresponding baseline HbA1c value as covariate.||-0.52|-0.75|<0.0001
73814467|NCT00435019|147178448|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis for the non-inferiority test was that the mean HbA1c with insulin detemir was greater than or equal to the mean HbA1c with NPH insulin plus 0.4%. A sample size of 344 subjects, in total, with a drop-out rate of 20 percent would yield 274 subjects for evaluation of HbA1c. This would give 85 percent power to detect a difference in means of HbA1c of 0.4 percentage points assuming that the standard deviation was 1.1 using a two-sided t-test with a 0.05 significance level.|Mean Difference (Final Values)|0.12||||||95.0|-0.12|0.36|||ANCOVA|||||0.36|-0.12|
73814468|NCT02301039|147178481|SUPERIORITY|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.|Binomial estimate of response rate of PR|17.5|||||TWO_SIDED|95.0|7.3|32.8|||||Clopper-Pearson (Exact) Confidence Interval. Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||32.8|7.3|
73814469|NCT02301039|147178481|SUPERIORITY||Binomial estimate of response rate of PR|5.0|||||TWO_SIDED|95.0|1.0|16.9|||||Clopper-Pearson exact confidence interval; Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||16.9|1.0|
73814470|NCT02301039|147178481|SUPERIORITY||Binomial estimate of response rate of PR|13.0|||||TWO_SIDED|95.0|5.5|25.3|||||Clopper-Pearson (Exact) Confidence Interval Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||25.3|5.5|
73814471|NCT00135356|147178541|SUPERIORITY_OR_OTHER||Difference in Means|0.03||||0.48||95.0|-0.06|0.12||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||LOCF||0.12|-0.06|0.48
73814472|NCT00135356|147178541|SUPERIORITY_OR_OTHER||Difference in Means|0.07||||0.57||95.0|-0.07|12.0||P-value not adjusted for multiple testing. 2-sided 95% CI|t-test, 2 sided|||OC||12.0|-0.07|0.57
73814473|NCT00135356|147178542|SUPERIORITY_OR_OTHER||Difference in Means|0.02||||0.73||95.0|-0.1|0.14||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||LOCF||0.14|-0.10|0.73
73814474|NCT00135356|147178542|SUPERIORITY_OR_OTHER||Difference in Means|-0.01||||0.91||95.0|-0.14|0.13||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||OC||0.13|-0.14|0.91
73814475|NCT00135356|147178543|SUPERIORITY_OR_OTHER||Difference in Mean|5.2||||0.27||95.0|-3.9|15.1||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 VAT LOCF||15.1|-3.9|0.27
73814476|NCT00135356|147178543|SUPERIORITY_OR_OTHER||Difference in Mean|1.8||||0.68||95.0|-6.7|11.2||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||VAT, Week 96 LOCF||11.2|-6.7|0.68
73814477|NCT00135356|147178543|SUPERIORITY_OR_OTHER||Difference in Means|4.4||||0.14||95.0|-1.4|10.6||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Trunk Fat LOCF||10.6|-1.4|0.14
73814478|NCT00135356|147178543|SUPERIORITY_OR_OTHER||Difference in Means|5.3||||0.14||95.0|-1.7|12.9||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Trunk Fat LOCF||12.9|-1.7|0.14
73814479|NCT00135356|147178544|SUPERIORITY_OR_OTHER||Difference in Means|4.0||||0.16||95.0|-1.6|10.0||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||SAT, Week 48, LOCF||10.0|-1.6|0.16
73814480|NCT00135356|147178544|SUPERIORITY_OR_OTHER||Difference in Mean|6.8||||0.06||95.0|-0.2|14.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 SAT||14.2|-0.2|0.06
73814481|NCT00135356|147178544|SUPERIORITY_OR_OTHER||Difference in Means|4.6||||0.15||95.0|-1.7|11.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48, Limb Fat||11.4|-1.7|0.15
73814482|NCT00135356|147178544|SUPERIORITY_OR_OTHER||Difference in Means|5.7||||0.17||95.0|-2.3|14.4||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||Week 96, Limb Fat||14.4|-2.3|0.17
73814483|NCT00135356|147178545|SUPERIORITY_OR_OTHER||DIfference in Means|3.6||||0.19||95.0|-1.8|9.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 TAT||9.4|-1.8|0.19
73814484|NCT00135356|147178545|SUPERIORITY_OR_OTHER||DIfference in Means|4.3||||0.16||95.0|-1.7|10.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|Wilcoxon (Mann-Whitney)|||Week 96 TAT||10.7|-1.7|0.16
73814485|NCT00135356|147178545|SUPERIORITY_OR_OTHER||Difference in Means|5.0||||0.0385||95.0|0.3|9.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Total Body Fat||9.7|0.3|0.0385
73814486|NCT00135356|147178545|SUPERIORITY_OR_OTHER||Difference in Means|5.9||||0.1||95.0|-1.0|13.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Total Body Fat||13.2|-1.0|0.10
73814487|NCT00135356|147178557|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.3|3.72||||||||3.72|0.3|
73814488|NCT01211483|147178573|SUPERIORITY||Hazard Ratio (HR)|0.978|||||TWO_SIDED|95.0|0.674|1.42||||||||1.420|0.674|
73814489|NCT01211483|147178573|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.523|1.131||||||||1.131|0.523|
73814490|NCT01211483|147178574|SUPERIORITY||Hazard Ratio (HR)|0.369||||0.0185|TWO_SIDED|95.0|0.161|0.846|||Cox proportional hazard|||||0.846|0.161|0.0185
73814491|NCT01211483|147178574|SUPERIORITY||Hazard Ratio (HR)|0.288||||0.0034|TWO_SIDED|95.0|0.125|0.663|||Cox proportional hazard|||||0.663|0.125|0.0034
73814492|NCT01211483|147178575|SUPERIORITY||Hazard Ratio (HR)|1.006||||0.9879|TWO_SIDED|95.0|0.458|2.212|||Cox proportional hazard|||||2.212|0.458|0.9879
73814493|NCT01211483|147178575|SUPERIORITY||Hazard Ratio (HR)|1.222||||0.6276|TWO_SIDED|95.0|0.544|2.746|||Cox proportional hazard|||||2.746|0.544|0.6276
73814494|NCT00460265|147178586|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.873||||0.1403||95.0|0.729|1.046|||Log Rank|Stratified by IVRS randomization factors (ECOG(0:1),previously treated w/ CT/RT(yes:no),primary tumor site(oropharynx/larynx:oral cavity/hypopharynx))|Hazard ratio from Cox proportional hazards model stratified by IVRS randomization factors; hazard ratio presented as panitumumab plus chemotherapy:chemotherapy alone.|||1.046|0.729|0.1403
73814495|NCT00460265|147178587|SUPERIORITY_OR_OTHER||Difference in percentages|10.98||||||95.0|3.13|18.68||||||||18.68|3.13|
73814496|NCT00460265|147178587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||||95.0|1.15|2.44||||||||2.44|1.15|
73814497|NCT00460265|147178591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||||95.0|0.659|0.922|||||Cox proportional hazards model stratified by IVRS randomization factors|||0.922|0.659|
73814498|NCT03878875|147178653|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|116.044|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient = -2.153.||||||< 0.0005
73814499|NCT03878875|147178654|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|12.839|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient = 1.602.||||||< 0.0005
73814500|NCT03878875|147178655|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|8.391|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient was 1.059.||||||< 0.0005
73814501|NCT03878875|147178656|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|6.416|||<|0.001|TWO_SIDED||||||Regression, Linear|Group coefficient was 0.635.||||||< 0.001
73814502|NCT03878875|147178657|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|5.805|||<|0.001|TWO_SIDED||||||Regression, Linear|Group coefficient was -0.383.||||||< 0.001
73814503|NCT03878875|147178658|SUPERIORITY|A binary logistic regression was employed to assess the effect of conditioning on tinnitus change (i.e. increasing or not) at session 2, adjusting for tinnitus reported at session 1, age, gender, and event exposure.|Odds Ratio (OR)|1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.005|TWO_SIDED|95.0|1.071|1.85|||Regression, Logistic|||||1.85|1.071|< 0.005
73814504|NCT00236899|147178661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.345||95.0|0.87|1.5|||Regression, Cox|||||1.50|0.87|0.345
73814505|NCT00236899|147178662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.885|TWO_SIDED|95.0|0.69|1.37|||Regression, Cox|||||1.37|0.69|0.885
73814506|NCT00236899|147178663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.976|TWO_SIDED|95.0|0.71|1.42|||Regression, Cox|||||1.42|0.71|0.976
73814507|NCT00236899|147178664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.442||||0.0028|TWO_SIDED|95.0|0.259|0.754|||Regression, Logistic|||||0.754|0.259|0.0028
73814508|NCT00236899|147178665|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.15|TWO_SIDED|95.0|0.93|1.62|||Regression, Cox|||||1.62|0.93|0.150
73814509|NCT00236899|147178666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.818||||0.4567|TWO_SIDED|95.0|0.482|1.389|||Regression, Logistic|||||1.389|0.482|0.4567
73814510|NCT00236899|147178668|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.142
73814511|NCT00236899|147178668|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.470
73814512|NCT00236899|147178669|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.293
73814513|NCT00236899|147178669|SUPERIORITY_OR_OTHER|||||||0.476||95.0||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.476
73814514|NCT03379792|147178670|OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
73814515|NCT03379792|147178670|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
73814516|NCT03379792|147178670|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
73814517|NCT03924505|147178671|SUPERIORITY||Incidence Rate Ratio|2.15|||<|0.01|TWO_SIDED|95.0|1.42|2.35||A priori threshold for statistical significance set at p\<0.05|Negative Binomial Regression|We adjusted for baseline rate due to baseline differences.|The incidence rate ratio estimates the effect of facilitation for implementation effectiveness and dissemination of best practice recommendations, as compared to dissemination of best practice recommendations.|||2.35|1.42|<0.01
73814518|NCT03924505|147178672|SUPERIORITY||Incidence Rate Ratio|1.97||||0.01|TWO_SIDED|95.0|1.18|3.3||A priori threshold for statistical signicance is p\<0.05|Negative Binomial Regression||The incidence rate ratio estimates the effect of facilitation for implementation effectiveness and dissemination of best practice recommendations, as compared to dissemination of best practice recommendations.|||3.30|1.18|0.01
73814519|NCT03924505|147178673|OTHER|Testing for differences in means|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.68|TWO_SIDED|95.0|-0.7|1.0|||t-test, 2 sided|||||1.0|-0.7|0.68
73814520|NCT02943785|147178701|NON_INFERIORITY|The two-sided p-value (Noninferiority) was based on the noninferiority margin of 1.38.|Cox Proportional Hazard|1.05||||0.0141|TWO_SIDED|95.0|0.85|1.31|||Regression, Cox|||||1.31|0.85|0.0141
73814521|NCT02943785|147178702|NON_INFERIORITY|The two-sided p-value (Noninferiority) was based on the noninferiority margin of 1.38.|Cox Proportional Hazard|1.4||||0.9267|TWO_SIDED|95.0|1.03|1.91|||Regression, Cox|||||1.91|1.03|0.9267
73814522|NCT01490697|147178779|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-18.0|16.0|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)|||16|-18|
73814523|NCT01490697|147178780|SUPERIORITY||Mean Difference (Net)|3.9|||||TWO_SIDED|95.0|-6.9|14.7|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)|||14.7|-6.9|
73814524|NCT00090584|147178781|SUPERIORITY_OR_OTHER||Difference in cumulative success rates|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.74|TWO_SIDED|95.0|-0.12|0.12|||Log Rank|||Kaplan Meier Lifetable analysis was used to compute the 8 month cumulative success rates.||0.12|-0.12|0.74
73814525|NCT00090584|147178782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|2.0||0.34|TWO_SIDED|95.0|-2.0|5.9||Mixed effect repeated measures analysis of variance controlling for study site.|ANOVA|||Test of hypothesis of no difference in change in episodes between the two groups.||5.9|-2.0|0.34
73814526|NCT00090584|147178783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-1.7|0.1||Repeated measures ANOVA controlling for clinical site.|ANOVA||Difference (group 1 - group 2) in change from baseline to follow-up in voids per day.|Null hypothesis of no difference between arms in change in number of voids per day from baseline to 10 weeks.||0.1|-1.7|0.08
73814527|NCT00090584|147178784|SUPERIORITY_OR_OTHER||Other|0.0||||0.0006||95.0||||Repeated measures ANOVA|Mixed Models Analysis|Main hypothesis tested by F-test for treatment by time interaction (2 and 509 degrees of freedom). No parameters estimated.||Null hypothesis is that there is no difference between treatment groups in improvement in UDI over time||||0.0006
73814528|NCT00090584|147178785|SUPERIORITY_OR_OTHER||Other|0.0||||0.0005||95.0||||P-value for test of time by treatment group interaction.|Mixed Models Analysis|Adjusted for study site||Repeated measures analysis of difference in symptom bother over time by treatment group.||||0.0005
73814529|NCT00090584|147178786|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.02|TWO_SIDED|95.0|1.09|2.92|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in Combination therapy arm to Drug only arm.|Null hypothesis: no difference in satisfaction at 10 weeks||2.92|1.09|0.02
73814530|NCT00090584|147178787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.02|TWO_SIDED|95.0|1.11|3.7|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in combination therapy group compared to drug only group.|Null hypothesis: No difference in satisfaction at 8 months post intervention||3.70|1.11|0.02
73814531|NCT00090584|147178788|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55||||0.008|TWO_SIDED|95.0|1.27|5.13||P-value from logistic regression analysis|Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement between women in combination therapy group compared to those in drug only group||5.13|1.27|0.008
73814532|NCT00090584|147178789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|95.0|1.83|5.52|||Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement at 8 months between women in combination therapy group compared to those in drug only group.||5.52|1.83|<0.0001
73814533|NCT03409120|147178790|SUPERIORITY||||||<|0.001|||||||linear mixed effects model|||We tested the equivalence of Burke-Fahn-Marsden scores over time (at baseline and at two time periods following DBS surgery) using a repeated measures ANOVA.||||<0.001
73814534|NCT02117713|147178814|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant; null hypothesis is that the mean change from baseline is equal to zero.|Mean Difference (Net)|-28.59|STANDARD_DEVIATION|89.456||0.1157|TWO_SIDED|95.0|-64.72|7.54|||Student's t-test||Difference is only calculated in participants who had baseline and week 48 values for n= 26|||7.54|-64.72|0.1157
73814535|NCT02117713|147178815|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant; null hypothesis is that the mean change from baseline is equal to zero.|Mean Difference (Net)|-45.15|STANDARD_DEVIATION|89.934||0.1469|TWO_SIDED|95.0|-109.48|19.19|||Student's t-test||||Difference is only calculated in participants who had baseline and week 216 values for n=10|19.19|-109.48|0.1469
73896454|NCT00913458|147326221|SUPERIORITY_OR_OTHER|||||||0.0286|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Final on therapy"||||0.0286
73896455|NCT00913458|147326222|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
73896456|NCT00913458|147326223|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
73814536|NCT02117713|147178816|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-2.353|STANDARD_DEVIATION|0.7124||0.005|TWO_SIDED|95.0|-3.101|-1.606|||Student's t-test||Difference is only calculated in participants who had baseline and week 218 values for n=6|||-1.606|-3.101|0.005
73814537|NCT02117713|147178817|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|56.0|STANDARD_DEVIATION|119.32||0.2607|TWO_SIDED|95.0|-54.4|166.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||166.4|-54.4|0.2607
73814538|NCT02117713|147178818|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-141.6|STANDARD_DEVIATION|216.25||0.134|TWO_SIDED|95.0|-341.6|58.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||58.4|-341.6|0.1340
73814539|NCT02117713|147178819|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|47.6|STANDARD_DEVIATION|75.68||0.1474|TWO_SIDED|95.0|-22.4|117.6|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||117.6|-22.4|0.1474
73814540|NCT02117713|147178820|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.58||1|TWO_SIDED|95.0|-0.5|0.5|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.5|-0.5|1.00
73814541|NCT02117713|147178821|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-1.7|STANDARD_DEVIATION|1.38||0.0167|TWO_SIDED|95.0|-3.0|-0.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||-0.4|-3|0.0167
73814542|NCT02117713|147178822|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|10.9|STANDARD_DEVIATION|245.92||0.9108|TWO_SIDED|95.0|-216.6|238.3|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||238.3|-216.6|0.9108
73814543|NCT02117713|147178823|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant(null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|0.1207|STANDARD_DEVIATION|1.882||0.1207|TWO_SIDED|95.0|-3.03|0.45|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.45|-3.03|0.1207
73814544|NCT02117713|147178824|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-0.943|STANDARD_DEVIATION|1.2488||0.0927|TWO_SIDED|95.0|-2.098|0.212|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.212|-2.098|0.0927
73814545|NCT02028169|147178826|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814546|NCT02028169|147178827|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814547|NCT02028169|147178828|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline Vs. Month 9||||< 0.001
73814548|NCT02028169|147178829|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814549|NCT02028169|147178830|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
73814550|NCT02028169|147178830|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
73814551|NCT02028169|147178830|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814552|NCT02028169|147178833|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
73814553|NCT02028169|147178833|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
73814554|NCT02028169|147178833|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814555|NCT02028169|147178834|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
73814556|NCT02028169|147178834|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
73814557|NCT02028169|147178834|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814558|NCT02028169|147178835|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814559|NCT02028169|147178836|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
73814560|NCT02028169|147178836|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
73814561|NCT02028169|147178836|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814562|NCT02028169|147178838|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814563|NCT02028169|147178840|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
73814564|NCT02028169|147178840|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
73814565|NCT02028169|147178840|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814566|NCT02028169|147178841|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
73814567|NCT02028169|147178841|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
73814568|NCT02028169|147178841|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814569|NCT02028169|147178842|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
73814570|NCT02028169|147178842|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
73814571|NCT02028169|147178842|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814572|NCT02028169|147178843|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
73814573|NCT02028169|147178843|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
73814574|NCT02028169|147178843|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814575|NCT02028169|147178844|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
73814576|NCT02028169|147178844|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
73814577|NCT02028169|147178844|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
73814578|NCT04907227|147178846|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.32|2.46|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.46|0.32|
73814579|NCT04907227|147178847|OTHER||Hazard Ratio (HR)|1.59|||||TWO_SIDED|95.0|0.68|3.67|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.67|0.68|
73814580|NCT04907227|147178848|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.45|1.5|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.50|0.45|
73814581|NCT04907227|147178850|OTHER||Percent Difference|4.3|||||TWO_SIDED|95.0|-24.1|31.2|||||Based on Miettinen \& Nurminen method.|||31.2|-24.1|
73814582|NCT04907227|147178852|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.17|1.99|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.99|0.17|
73814583|NCT04907227|147178853|OTHER||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.15|18.24|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||18.24|0.15|
73814584|NCT04907227|147178854|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.41|1.46|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.46|0.41|
73814585|NCT04907227|147178855|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.43|3.17|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.17|0.43|
73814586|NCT00824434|147178866|SUPERIORITY_OR_OTHER||Mean In-stent Late Loss in WH Lesions|0.17|||<|0.0001|ONE_SIDED|95.0||0.22|||t-test, 1 sided|||The Student t-test was used to compare the outcome to a prespecified performance goal of 0.44 mm based on an historical TAXUS Express workhorse 9-month in-stent late loss (0.41 mm) value plus delta (0.03 mm)||0.22||<0.0001
73814587|NCT00824434|147178867|SUPERIORITY_OR_OTHER||Percent Post-procedure Incomplete Apposi|5.7|||<|0.0001|ONE_SIDED|95.0||11.6|||One-sided exact binomial test|||A one-sided 95% Clopper-Pearson upper confidence bound was derived and tested to determine if the outcome was less than a prespecified performance goal based on historical XIENCE V/PROMUS post-procedure incomplete apposition data from the SPIRIT III study (34.4%).||11.6||<0.0001
73814588|NCT00432276|147178881|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.47|||||ONE_SIDED|97.5||-0.35|||ANCOVA||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.||-0.35||
73814589|NCT00432276|147178881|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.42|||||ONE_SIDED|97.5||-0.28|||ANCOVA||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|Comparison of Change from Baseline at Week 52. The null hypothesis was that the average change from Baseline in HbA1c at Week 52 for the alogliptin 25 mg addition group is inferior to the average change for the pioglitazone titration group. The alternative hypothesis was that the change from Baseline in HbA1c for the alogliptin 25 mg addition group was non-inferior to the change for the pioglitazone titration group for at Week 52.||-0.28||
73814590|NCT00432276|147178882|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.57|-0.31||Statistical tests and resulting P-values are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.||Comparison of change from Baseline in HbA1c at Week 42.||-0.31|-0.57|<0.001
73814591|NCT00432276|147178890|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-16.2|-5.7||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and FPG as covariates.||Comparison of change from Baseline at Week 52.||-5.7|-16.2|<0.001
73896457|NCT00913458|147326224|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13"||||0.0063
73896458|NCT00913458|147326224|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 26"||||0.0053
73896459|NCT00913458|147326224|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 39"||||0.0027
73896460|NCT00913458|147326224|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 52"||||0.0002
73896461|NCT00913458|147326224|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Final on therapy"||||0.0005
73814592|NCT00432276|147178891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of marked hyperglycemia through Week 52.||||<0.001
73814593|NCT00432276|147178892|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of hyperglycemic rescue through Week 52.||||<0.001
73814594|NCT00432276|147178893|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.116|TWO_SIDED|95.0|-3.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and proinsulin as covariates.||Comparison of change from Baseline at Week 52.||0.4|-3.7|0.116
73814595|NCT00432276|147178894|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.276|TWO_SIDED|95.0|-0.58|2.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and fasting insulin as covariates.||Comparison of change from Baseline at Week 52.||2.04|-0.58|0.276
73814596|NCT00432276|147178895|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.041|||<|0.001|TWO_SIDED|95.0|-0.063|-0.018||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as covariates.||Comparison of change from Baseline at Week 52.||-0.018|-0.063|<0.001
73814597|NCT00432276|147178896|SUPERIORITY_OR_OTHER||LS Mean Difference|0.073||||0.23|TWO_SIDED|95.0|-0.047|0.193||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting C-peptide as covariates.||Comparison of change from Baseline at Week 52.||0.193|-0.047|0.230
73814598|NCT00432276|147178897|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.188||||0.567|TWO_SIDED|95.0|-0.83|0.455||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA insulin resistance as covariates.||Comparison of change from Baseline at Week 52.||0.455|-0.830|0.567
73814599|NCT00432276|147178898|SUPERIORITY_OR_OTHER||LS Mean Difference|12.963|||<|0.001|TWO_SIDED|95.0|5.333|20.592||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as covariates.||Comparison of change from Baseline at Week 52.||20.592|5.333|<0.001
73814600|NCT00432276|147178899|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.071|TWO_SIDED|95.0|-1.03|0.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline body weight as covariates.||Comparison of change from Baseline at Week 52.||0.04|-1.03|0.071
73814601|NCT00432276|147178900|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2||||0.058|TWO_SIDED|95.0|-8.6|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.1|-8.6|0.058
73814602|NCT00432276|147178901|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.228|TWO_SIDED|95.0|-1.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.4|-1.7|0.228
73814603|NCT00432276|147178902|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8||||0.132|TWO_SIDED|95.0|-6.5|0.9||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.9|-6.5|0.132
73814604|NCT00432276|147178903|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.6||||0.08|TWO_SIDED|95.0|-18.3|1.0||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline triglycerides as covariates.||Comparison of change from Baseline at Week 52.||1.0|-18.3|0.080
73814605|NCT00432276|147178904|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0314||||0.059|TWO_SIDED|95.0|-0.064|0.0012||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as covariates.||Comparison of change from Baseline at Week 52.||0.0012|-0.0640|0.059
73814606|NCT00432276|147178905|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.934|TWO_SIDED|95.0|-2.9|2.6||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as covariates.||Comparison of change from Baseline at Week 52.||2.6|-2.9|0.934
73814607|NCT00432276|147178906|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.07|TWO_SIDED|95.0|-1.3|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as covariates.||Comparison of change from Baseline at Week 52.||0.1|-1.3|0.070
73814608|NCT00432276|147178907|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9||||0.064|TWO_SIDED|95.0|-5.9|0.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as covariates.||Comparison of change from Baseline at Week 52.||0.2|-5.9|0.064
73814609|NCT00432276|147178908|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.022|TWO_SIDED|95.0|-1.0|-0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as covariates.||Comparison of change from Baseline at Week 52.||-0.1|-1.0|0.022
73814610|NCT00432276|147178909|SUPERIORITY_OR_OTHER||LS Mean Difference|1.78||||0.308|TWO_SIDED|95.0|-1.65|5.22||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as covariates.||Comparison of change from Baseline at Week 52.||5.22|-1.65|0.308
73814611|NCT00432276|147178910|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8209||||0.283|TWO_SIDED|95.0|-2.3209|0.679||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline hsCRP as covariates.||Comparison of change from Baseline at Week 52.||0.6790|-2.3209|0.283
73814612|NCT00432276|147178911|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.92|||<|0.001|TWO_SIDED|95.0|-4.57|-1.27||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline adiponectin as covariates.||Comparison of change from Baseline at Week 52.||-1.27|-4.57|<0.001
73814613|NCT00432276|147178912|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1||||0.197|TWO_SIDED|95.0|-15.4|3.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|||Comparison of change from Baseline at Week 52.||3.2|-15.4|0.197
73814614|NCT02436031|147178943|OTHER|||||||0.049|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit||||0.049
73814615|NCT02436031|147178943|OTHER|||||||0.135|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit||||0.135
73814616|NCT03168919|147178946|OTHER|Comparison||||||||||||||||The baseline and the end of therapy MRI parameters are compared.|Due to very small accrual, the statistical analysis couln't be performed.|||
73814617|NCT01085136|147178951|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61||||0.003|TWO_SIDED|95.0|0.44|0.85||P-value is calculated from two-sided stratified log-rank test|stratified log-rank test|||Hazard ratio is calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (\<6 months vs \>=6 months).||0.85|0.44|0.0030
73814618|NCT01085136|147178953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.7905|TWO_SIDED|95.0|0.76|1.44|||Stratified log-rank test.|P-value is calculated from two-sided stratified log-rank test.||Hazard ratio was calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (\<6 months vs \>=6 months).||1.44|0.76|0.7905
73814619|NCT01085136|147178955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.98||||0.0065|TWO_SIDED|95.0|1.357|6.543|||Regression, Logistic|||Odds ratio, 95% Confidence Interval (CI) and p-value (two-sided) from logistic regression stratified for maximum treatment duration of prior erlotinib or gefitinib (\>=6 months vs \<6 months) and gender.||6.543|1.357|0.0065
73814620|NCT03759366|147179010|SUPERIORITY||Least Square Mean|-5.8||||0.0004|TWO_SIDED|95.0|-8.4|-3.13|||Repeated Measures Model||The least square mean change from baseline in QMG total score at Week 26 was calculated.|The observed change in QMG was analyzed with baseline QMG score and visits as covariates.||-3.13|-8.40|0.0004
73814621|NCT03759366|147179024|SUPERIORITY||Least Square Mean|-4.3||||0.0033|TWO_SIDED|95.0|-6.93|-1.65|||Repeated Measures Model||The least square mean change from baseline in QMG total score at Week 52 was calculated.|The observed change in QMG was analyzed with baseline QMG score and visits as covariates.||-1.65|-6.93|0.0033
73814622|NCT02440854|147179077|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.002
73814623|NCT02440854|147179077|OTHER|||||||0.014|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.014
73814624|NCT02440854|147179077|OTHER|||||||0.246|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.246
73814625|NCT02440854|147179077|OTHER|||||||0.103|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.103
73814626|NCT02440854|147179077|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.004
73814627|NCT02440854|147179077|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
73814628|NCT02440854|147179077|OTHER|||||||0.012|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.012
73814629|NCT02440854|147179077|OTHER|||||||0.024|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.024
73814630|NCT02440854|147179077|OTHER|||||||0.009|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.009
73814631|NCT02440854|147179077|OTHER|||||||0.008|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.008
73814632|NCT02440854|147179078|OTHER|||||||0.027|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.027
73814633|NCT02440854|147179078|OTHER|||||||0.03|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.030
73814634|NCT02440854|147179078|OTHER|||||||0.351|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.351
73814635|NCT02440854|147179078|OTHER|||||||0.143|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.143
73814636|NCT02440854|147179078|OTHER|||||||0.163|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.163
73814637|NCT02440854|147179078|OTHER|||||||0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.001
73814638|NCT02440854|147179078|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.003
73814639|NCT02440854|147179078|OTHER|||||||0.036|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.036
73814640|NCT02440854|147179078|OTHER|||||||0.043|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.043
73814641|NCT02440854|147179078|OTHER|||||||0.04|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.040
73814642|NCT02440854|147179079|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
73814643|NCT02440854|147179079|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.003
73814644|NCT02440854|147179079|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
73814645|NCT02440854|147179079|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
73814646|NCT02440854|147179079|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
73814647|NCT02440854|147179079|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
73814648|NCT02440854|147179079|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
73814649|NCT02440854|147179079|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
73814650|NCT02440854|147179079|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
73814651|NCT02440854|147179079|OTHER|||||||0.163|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.163
73814652|NCT02440854|147179080|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.003
73814653|NCT02440854|147179080|OTHER|||||||0.009|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.009
73814654|NCT02440854|147179080|OTHER|||||||0.012|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.012
73814655|NCT02440854|147179080|OTHER|||||||0.332|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.332
73814656|NCT02440854|147179080|OTHER|||||||0.029|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.029
73814657|NCT02440854|147179080|OTHER|||||||0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.001
73814658|NCT02440854|147179080|OTHER|||||||0.177|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.177
73814659|NCT02440854|147179080|OTHER|||||||0.436|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.436
73814660|NCT02440854|147179080|OTHER|||||||0.302|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.302
73814661|NCT02440854|147179080|OTHER|||||||0.291|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.291
73814662|NCT02440854|147179081|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
73814663|NCT02440854|147179081|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
73814664|NCT02440854|147179081|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
73814665|NCT02440854|147179081|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
73814666|NCT02440854|147179081|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
73814667|NCT02440854|147179081|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
73814668|NCT02440854|147179081|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
73814669|NCT02440854|147179081|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
73814670|NCT02440854|147179081|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.002
73814671|NCT02440854|147179081|OTHER|||||||0.025|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.025
73814672|NCT02440854|147179082|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
73814673|NCT02440854|147179082|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
73814674|NCT02440854|147179082|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
73814675|NCT02440854|147179082|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
73814676|NCT02440854|147179082|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
73814677|NCT02440854|147179082|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
73814678|NCT02440854|147179082|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
73814679|NCT02440854|147179082|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
73814680|NCT02440854|147179082|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.003
73814681|NCT02440854|147179082|OTHER|||||||0.025|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.025
73814682|NCT02440854|147179083|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
73814683|NCT02440854|147179083|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
73814684|NCT02440854|147179083|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
73814685|NCT02440854|147179083|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
73814686|NCT02440854|147179083|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
73814687|NCT02440854|147179083|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
73814688|NCT02440854|147179083|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
73814689|NCT02440854|147179083|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
73814690|NCT02440854|147179083|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
73814691|NCT02440854|147179083|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||<0.001
73814692|NCT02440854|147179084|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
73814693|NCT02440854|147179084|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
73814694|NCT02440854|147179084|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
73814695|NCT02440854|147179084|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
73814696|NCT02440854|147179084|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
73814697|NCT02440854|147179084|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
73814698|NCT02440854|147179084|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
73814699|NCT02440854|147179084|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
73814700|NCT02440854|147179084|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
73814701|NCT02440854|147179084|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.002
73814702|NCT02440854|147179085|OTHER|||||||0.022|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.022
73814703|NCT02440854|147179085|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
73814704|NCT02440854|147179085|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.004
73814705|NCT02440854|147179085|OTHER|||||||0.032|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.032
73814706|NCT02440854|147179085|OTHER|||||||0.066|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.066
73814707|NCT02440854|147179085|OTHER|||||||0.042|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.042
73814708|NCT02440854|147179085|OTHER|||||||0.045|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.045
73814709|NCT02440854|147179085|OTHER|||||||0.014|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.014
73814710|NCT02440854|147179085|OTHER|||||||0.015|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.015
73814711|NCT02440854|147179085|OTHER|||||||0.462|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.462
73814712|NCT02440854|147179086|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
73814713|NCT02440854|147179086|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.004
73814714|NCT02440854|147179086|OTHER|||||||0.008|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.008
73814715|NCT02440854|147179086|OTHER|||||||0.315|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.315
73814716|NCT02440854|147179086|OTHER|||||||0.237|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.237
73814717|NCT02440854|147179086|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
73814718|NCT02440854|147179086|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.002
73814719|NCT02440854|147179086|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.004
73814720|NCT02440854|147179086|OTHER|||||||0.01|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.010
73814721|NCT02440854|147179086|OTHER|||||||0.683|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.683
73814722|NCT02440854|147179087|OTHER|||||||0.062|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.062
73814723|NCT02440854|147179087|OTHER|||||||0.062|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.062
73814724|NCT02440854|147179087|OTHER|||||||0.027|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.027
73814725|NCT02440854|147179087|OTHER|||||||0.17|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.170
73814726|NCT02440854|147179087|OTHER|||||||0.271|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.271
73814727|NCT02440854|147179087|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.002
73814728|NCT02440854|147179087|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.003
73814729|NCT02440854|147179087|OTHER|||||||0.157|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.157
73814730|NCT02440854|147179087|OTHER|||||||0.064|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.064
73814731|NCT02440854|147179087|OTHER|||||||0.439|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.439
73814732|NCT02440854|147179088|OTHER|||||||0.388|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.388
73814733|NCT02440854|147179088|OTHER|||||||0.006|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||0.006
73814734|NCT02440854|147179088|OTHER|||||||0.077|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.077
73814735|NCT02440854|147179088|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
73814736|NCT02440854|147179088|OTHER|||||||0.508|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.508
73814737|NCT02440854|147179088|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
73814738|NCT02440854|147179088|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
73814739|NCT02440854|147179088|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
73814740|NCT02440854|147179088|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
73814741|NCT02440854|147179088|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
73814742|NCT02440854|147179089|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||>0.999
73814743|NCT02440854|147179089|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||>0.999
73814744|NCT02440854|147179089|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||>0.999
73814745|NCT02440854|147179089|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
73814746|NCT02440854|147179089|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||>0.999
73814747|NCT02440854|147179089|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
73814748|NCT02440854|147179089|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
73814749|NCT02440854|147179090|OTHER|||||||0.774|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.774
73814750|NCT02440854|147179090|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||>0.999
73814751|NCT02440854|147179090|OTHER|||||||0.607|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.607
73814752|NCT02440854|147179090|OTHER|||||||0.774|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||0.774
73814753|NCT02440854|147179090|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||>0.999
73814754|NCT02440854|147179090|OTHER|||||||0.453|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||0.453
73814755|NCT02440854|147179090|OTHER|||||||0.688|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||0.688
73814756|NCT02440854|147179090|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
73814757|NCT02440854|147179090|OTHER|||||||0.25|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||0.250
73814758|NCT02440854|147179090|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
73814759|NCT02440854|147179091|OTHER|||||||0.077|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.077
73814760|NCT02440854|147179091|OTHER||||||<|0.001|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||<0.001
73814761|NCT02440854|147179091|OTHER|||||||0.006|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.006
73814762|NCT02440854|147179091|OTHER|||||||0.344|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||0.344
73814763|NCT02440854|147179091|OTHER|||||||0.146|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.146
73814764|NCT02440854|147179091|OTHER|||||||0.18|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||0.180
73814765|NCT02440854|147179091|OTHER|||||||0.289|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||0.289
73814766|NCT02440854|147179091|OTHER|||||||0.125|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||0.125
73814767|NCT02440854|147179091|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
73814768|NCT02440854|147179091|OTHER|||||||0.5|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||0.500
73814769|NCT02440854|147179092|OTHER|||||||0.21|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.210
73814770|NCT02440854|147179092|OTHER|||||||0.263|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||0.263
73814771|NCT02440854|147179092|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||>0.999
73814772|NCT02440854|147179092|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
73814773|NCT02440854|147179092|OTHER|||||||0.629|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.629
73814774|NCT02440854|147179092|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
73814775|NCT02440854|147179092|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
73814776|NCT02440854|147179092|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
73814777|NCT02440854|147179092|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
73814778|NCT02440854|147179092|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
73814779|NCT02440854|147179093|OTHER|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 2-month post-baseline.||||0.098
73814780|NCT02440854|147179093|OTHER|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 4-month post-baseline.||||0.359
73814781|NCT02440854|147179093|OTHER|||||||0.393|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 6-month post-baseline.||||0.393
73814782|NCT02440854|147179093|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 8-month post-baseline.||||0.055
73814783|NCT02440854|147179093|OTHER|||||||0.124|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 10-month post-baseline.||||0.124
73814784|NCT02440854|147179093|OTHER|||||||0.376|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 12-month post-baseline.||||0.376
73814785|NCT02440854|147179093|OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 18-month post-baseline.||||0.033
73814786|NCT02440854|147179093|OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 24-month post-baseline.||||0.048
73814787|NCT02440854|147179093|OTHER|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 30-month post-baseline.||||0.071
73814788|NCT02440854|147179093|OTHER|||||||0.848|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 36-month post-baseline.||||0.848
73814789|NCT02243046|147179118|SUPERIORITY_OR_OTHER|||||||0.091|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.091
73814790|NCT02243046|147179119|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
73814791|NCT02243046|147179120|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
73814792|NCT02243046|147179121|SUPERIORITY_OR_OTHER|||||||0.571|||||||ANOVA|||The null hypothesis states that there is no difference between groups||||0.571
73814793|NCT02243046|147179122|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
73814794|NCT02243046|147179123|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
73814795|NCT02669082|147179124|OTHER|||||||0.2955|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.2955
73814796|NCT02669082|147179125|OTHER|||||||0.1358|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1358
73814797|NCT02669082|147179126|OTHER||Median|||||0.1706|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1706
73814798|NCT02669082|147179127|OTHER|||||||0.1969|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1969
73814799|NCT02669082|147179128|OTHER|||||||0.0534|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0534
73814800|NCT02669082|147179129|OTHER|||||||0.4125|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.4125
73814801|NCT02669082|147179130|OTHER|||||||0.022|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0220
73814802|NCT02669082|147179131|OTHER|||||||0.042|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0420
73814803|NCT02669082|147179132|OTHER|||||||0.8166|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.8166
73814804|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.527||||0.0211|TWO_SIDED|95.0|0.306|0.908|||Regression, Logistic|||The statistical analysis is presented for Gamma-Glutamyl Transferase (Gamma-GT) in log10 international units per liter (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \[Wk\]12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.908|0.306|0.0211
73814805|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078|||<|0.0001|TWO_SIDED|95.0|1.065|1.092|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.092|1.065|<0.0001
73814806|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0053|TWO_SIDED|95.0|1.061|1.403|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.403|1.061|0.0053
73814807|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.464||||0.0079|TWO_SIDED|95.0|0.264|0.818|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.818|0.264|0.0079
73814808|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.737||||0.1808|TWO_SIDED|95.0|0.471|1.153|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.153|0.471|0.1808
73814809|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.082|||<|0.0001|TWO_SIDED|95.0|1.069|1.095|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.095|1.069|<0.0001
73814810|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.676||||0.0005|TWO_SIDED|95.0|0.542|0.844|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kilogram (kg). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.844|0.542|0.0005
73814811|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.573||||0.0041|TWO_SIDED|95.0|0.392|0.838|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.838|0.392|0.0041
73814812|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.094|||<|0.0001|TWO_SIDED|95.0|1.048|1.142|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.142|1.048|<0.0001
73814813|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.945||||0.0031|TWO_SIDED|95.0|2.013|31.359|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||31.359|2.013|0.0031
73814814|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.0012|TWO_SIDED|95.0|0.844|0.959|||Regression, Logistic|||The statistical analysis is presented for body mass index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.959|0.844|0.0012
73814815|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.619||||0.0085|TWO_SIDED|95.0|0.433|0.885|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.885|0.433|0.0085
73814816|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||<|0.0001|TWO_SIDED|95.0|1.087|1.174|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.174|1.087|<0.0001
73814817|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.784||||0.0341|TWO_SIDED|95.0|0.626|0.982|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.982|0.626|0.0341
73814818|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.575||||0.0443|TWO_SIDED|95.0|0.335|0.986|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.986|0.335|0.0443
73814819|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||<|0.0001|TWO_SIDED|95.0|1.057|1.144|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.144|1.057|<0.0001
73814820|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.867||||0.0039|TWO_SIDED|95.0|2.73|191.56|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||191.56|2.730|0.0039
73814821|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.0244|TWO_SIDED|95.0|0.628|0.968|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||0.968|0.628|0.0244
73814822|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.128|||<|0.0001|TWO_SIDED|95.0|1.086|1.172|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.172|1.086|<0.0001
73814823|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.547||||0.0453|TWO_SIDED|95.0|0.303|0.987|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.987|0.303|0.0453
73814824|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.133||||0.0184|TWO_SIDED|95.0|0.025|0.712|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.712|0.025|0.0184
73814825|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.103|||<|0.0001|TWO_SIDED|95.0|1.072|1.134|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in Weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.134|1.072|<0.0001
73814826|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.543||||0.0019|TWO_SIDED|95.0|0.37|0.798|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.798|0.370|0.0019
73814827|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.359||||0.0017|TWO_SIDED|95.0|0.189|0.679|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.679|0.189|0.0017
73814828|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08|||<|0.0001|TWO_SIDED|95.0|1.047|1.114|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.114|1.047|<0.0001
73814829|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.093||||0.0042|TWO_SIDED|95.0|1.029|1.162|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.162|1.029|0.0042
73814830|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.535||||0.0168|TWO_SIDED|95.0|0.32|0.893|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.893|0.320|0.0168
73814831|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.501||||0.0128|TWO_SIDED|95.0|0.291|0.864|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.864|0.291|0.0128
73896462|NCT00913458|147326225|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
73814832|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.853||||0.4634|TWO_SIDED|95.0|0.558|1.305|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.305|0.558|0.4634
73814833|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.655|||<|0.0001|TWO_SIDED|95.0|9.725|39.722|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (Rapid Virological Response \[RVR\] vs No RVR/EVR \[Early Virological Response\]). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||39.722|9.725|<0.0001
73814834|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.569|||<|0.0001|TWO_SIDED|95.0|4.408|16.658|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR \[Complete Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||16.658|4.408|<0.0001
73814835|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.519||||0.0089|TWO_SIDED|95.0|1.26|5.034|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR \[Partial Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.034|1.260|0.0089
73814836|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.908||||0.0037|TWO_SIDED|95.0|0.851|0.969|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.969|0.851|0.0037
73814837|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.553||||0.002|TWO_SIDED|95.0|0.379|0.805|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.805|0.379|0.0020
73814838|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.537||||0.0003|TWO_SIDED|95.0|3.654|74.849|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||74.849|3.654|0.0003
73814839|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.386||||0.0733|TWO_SIDED|95.0|0.87|22.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||22.114|0.870|0.0733
73814840|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.352||||0.3478|TWO_SIDED|95.0|0.394|14.031|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||14.031|0.394|0.3478
73814841|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.729||||0.0264|TWO_SIDED|95.0|0.552|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.964|0.552|0.0264
73814842|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.658||||0.0096|TWO_SIDED|95.0|1.586|27.946|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||27.946|1.586|0.0096
73814843|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.734||||0.0421|TWO_SIDED|95.0|1.057|21.203|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||21.203|1.057|0.0421
73814844|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.602||||0.6004|TWO_SIDED|95.0|0.09|4.014|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.014|0.090|0.6004
73814845|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.715||||0.0418|TWO_SIDED|95.0|0.517|0.988|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.988|0.517|0.0418
73814846|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.198||||0.0279|TWO_SIDED|95.0|0.047|0.839|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.839|0.047|0.0279
73814847|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|40.88|||<|0.0001|TWO_SIDED|95.0|7.474|223.61|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||223.61|7.474|<0.0001
73814848|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|42.395|||<|0.0001|TWO_SIDED|95.0|8.724|206.02|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||206.02|8.724|<0.0001
73814849|NCT01066793|147179185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.247||||0.0087|TWO_SIDED|95.0|1.704|39.908|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||39.908|1.704|0.0087
73814850|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.957||||0.0002|TWO_SIDED|95.0|1.383|2.77|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.770|1.383|0.0002
73814851|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.337||||0.0007|TWO_SIDED|95.0|1.661|6.705|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.705|1.661|0.0007
73814852|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.305||||0.3611|TWO_SIDED|95.0|0.737|2.312|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.312|0.737|0.3611
73814853|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.943|||<|0.0001|TWO_SIDED|95.0|0.929|0.958|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.958|0.929|<0.0001
73814854|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.743||||0.002|TWO_SIDED|95.0|0.615|0.897|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.897|0.615|0.0020
73814855|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.864||||0.0004|TWO_SIDED|95.0|1.322|2.628|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.628|1.322|0.0004
73814856|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.124||||0.0386|TWO_SIDED|95.0|1.04|4.338|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.338|1.040|0.0386
73814857|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.398||||0.0004|TWO_SIDED|95.0|1.722|6.706|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.706|1.722|0.0004
73814858|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.372||||0.2769|TWO_SIDED|95.0|0.776|2.428|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.428|0.776|0.2769
73814859|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.945|||<|0.0001|TWO_SIDED|95.0|0.931|0.96|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.960|0.931|<0.0001
73814860|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.163||||0.0001|TWO_SIDED|95.0|1.078|1.256|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.256|1.078|0.0001
73814861|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.788||||0.0213|TWO_SIDED|95.0|1.091|2.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.932|1.091|0.0213
73814862|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.0002|TWO_SIDED|95.0|0.856|0.953|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.953|0.856|0.0002
73814863|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.723||||0.0306|TWO_SIDED|95.0|0.538|0.97|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.538|0.0306
73814864|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.145||||0.0005|TWO_SIDED|95.0|1.061|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.236|1.061|0.0005
73814865|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.907||||0.0122|TWO_SIDED|95.0|1.151|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.151|0.0122
73814866|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.175||||0.0956|TWO_SIDED|95.0|0.872|5.424|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.424|0.872|0.0956
73814867|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.267||||0.0846|TWO_SIDED|95.0|0.06|1.197|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.197|0.060|0.0846
73814868|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.897|||<|0.0001|TWO_SIDED|95.0|0.852|0.945|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.945|0.852|<0.0001
73814869|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.996||||0.0033|TWO_SIDED|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.165|1.259|0.0033
73814870|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0095|TWO_SIDED|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.277|1.035|0.0095
73814871|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0031|TWO_SIDED|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.533|0.045|0.0031
73814872|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.0645|TWO_SIDED|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|0.125|0.0645
73814873|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.895||||0.0001|TWO_SIDED|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.948|0.846|0.0001
73814874|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.996||||0.0033|TWO_SIDED|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.165|1.259|0.0033
73814875|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0095|TWO_SIDED|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.277|1.035|0.0095
73814876|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0031|TWO_SIDED|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.533|0.045|0.0031
73814877|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.0645|TWO_SIDED|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|0.125|0.0645
73814878|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.895||||0.0001|TWO_SIDED|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.948|0.846|0.0001
73814879|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.266||||0.0182|TWO_SIDED|95.0|1.041|1.541|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.541|1.041|0.0182
73814880|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.0092|TWO_SIDED|95.0|1.122|2.254|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.254|1.122|0.0092
73814881|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.974||||0.002|TWO_SIDED|95.0|1.488|5.942|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.942|1.488|0.0020
73814882|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.142||||0.6524|TWO_SIDED|95.0|0.641|2.035|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.035|0.641|0.6524
73814883|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.108|||<|0.0001|TWO_SIDED|95.0|0.037|0.311|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.311|0.037|<0.0001
73814884|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.389||||0.0429|TWO_SIDED|95.0|0.156|0.97|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.156|0.0429
73814885|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.549|TWO_SIDED|95.0|0.523|3.38|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.380|0.523|0.5490
73814886|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.0008|TWO_SIDED|95.0|1.054|1.224|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.224|1.054|0.0008
73814887|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.855||||0.014|TWO_SIDED|95.0|1.133|3.037|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.037|1.133|0.0140
73896463|NCT00913458|147326226|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
73896464|NCT00913458|147326227|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
73814888|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.126||||0.0575|TWO_SIDED|95.0|0.015|1.068|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.068|0.015|0.0575
73814889|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.7128|TWO_SIDED|95.0|0.072|6.025|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.025|0.072|0.7128
73814890|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.505||||0.596|TWO_SIDED|95.0|0.04|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.318|0.040|0.5960
73814891|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.051||||0.0033|TWO_SIDED|95.0|1.27|3.311|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.311|1.270|0.0033
73814892|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.113||||0.0452|TWO_SIDED|95.0|1.002|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.236|1.002|0.0452
73814893|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.154||||0.004|TWO_SIDED|95.0|0.043|0.551|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.551|0.043|0.0040
73814894|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.393||||0.0833|TWO_SIDED|95.0|0.137|1.131|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||1.131|0.137|0.0833
73814895|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.141||||0.1439|TWO_SIDED|95.0|0.01|1.951|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.951|0.010|0.1439
73814896|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35||||0.4457|TWO_SIDED|95.0|0.024|5.194|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.194|0.024|0.4457
73814897|NCT01066793|147179199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.142||||0.6258|TWO_SIDED|95.0|0.1|45.801|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||45.801|0.100|0.6258
73814898|NCT03334422|147179212|SUPERIORITY||Odds Ratio (OR)|2.58||||0.026|TWO_SIDED|95.0|1.12|5.92|||Regression, Logistic|||||5.92|1.12|0.026
73814899|NCT03334422|147179212|SUPERIORITY||Odds Ratio (OR)|3.64||||0.001|TWO_SIDED|95.0|1.64|8.05|||Regression, Logistic|||||8.05|1.64|0.001
73814900|NCT03334422|147179213|SUPERIORITY||Odds Ratio (OR)|2.13||||0.085|TWO_SIDED|95.0|0.9|5.02|||Regression, Logistic|||||5.02|0.90|0.085
73814901|NCT03334422|147179214|SUPERIORITY||Odds Ratio (OR)|2.35||||0.024|TWO_SIDED|95.0|1.12|4.93|||Regression, Logistic|||||4.93|1.12|0.024
73814902|NCT03334422|147179214|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.73|7.04|||Regression, Logistic|||||7.04|1.73|<0.001
73814903|NCT03334422|147179214|SUPERIORITY||Odds Ratio (OR)|4.41|||<|0.001|TWO_SIDED|95.0|2.22|8.76|||Regression, Logistic|||||8.76|2.22|<0.001
73814904|NCT03334422|147179215|SUPERIORITY||Odds Ratio (OR)|2.8||||0.053|TWO_SIDED|95.0|0.99|7.97|||Regression, Logistic|||||7.97|0.99|0.053
73814905|NCT03334422|147179215|SUPERIORITY||Odds Ratio (OR)|3.87||||0.007|TWO_SIDED|95.0|1.44|10.41|||Regression, Logistic|||||10.41|1.44|0.007
73814906|NCT03334422|147179215|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|2.42|15.91|||Regression, Logistic|||||15.91|2.42|<0.001
73814907|NCT03334422|147179216|SUPERIORITY||Mean Difference (Net)|-12.76|STANDARD_ERROR_OF_MEAN|6.81||0.062|TWO_SIDED|95.0|-26.19|0.66|||Mixed Models Analysis|||||0.66|-26.19|0.062
73814908|NCT03334422|147179216|SUPERIORITY||Mean Difference (Net)|-25.89|STANDARD_ERROR_OF_MEAN|6.54|<|0.001|TWO_SIDED|95.0|-38.78|-12.99|||Mixed Models Analysis|||||-12.99|-38.78|<0.001
73814909|NCT03334422|147179216|SUPERIORITY||Mean Difference (Net)|-25.97|STANDARD_ERROR_OF_MEAN|6.24|<|0.001|TWO_SIDED|95.0|-38.29|-13.65|||Mixed Models Analysis|||||-13.65|-38.29|<0.001
73814910|NCT03334422|147179217|SUPERIORITY||Odds Ratio (OR)|2.9||||0.086|TWO_SIDED|95.0|0.86|9.76|||Regression, Logistic|||||9.76|0.86|0.086
73814911|NCT03334422|147179217|SUPERIORITY||Odds Ratio (OR)|4.95||||0.006|TWO_SIDED|95.0|1.58|15.49|||Regression, Logistic|||||15.49|1.58|0.006
73814912|NCT03334422|147179217|SUPERIORITY||Odds Ratio (OR)|7.4|||<|0.001|TWO_SIDED|95.0|2.51|21.83|||Regression, Logistic|||||21.83|2.51|<0.001
73814913|NCT03334422|147179218|SUPERIORITY||Odds Ratio (OR)|1.41||||0.505|TWO_SIDED|95.0|0.51|3.87|||Regression, Logistic|||||3.87|0.51|0.505
73814914|NCT03334422|147179218|SUPERIORITY||Odds Ratio (OR)|3.64||||0.002|TWO_SIDED|95.0|1.6|8.27|||Regression, Logistic|||||8.27|1.60|0.002
73814915|NCT03334422|147179218|SUPERIORITY||Odds Ratio (OR)|4.91|||<|0.001|TWO_SIDED|95.0|2.22|10.86|||Regression, Logistic|||||10.86|2.22|<0.001
73814916|NCT03334422|147179219|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.074|TWO_SIDED|95.0|-0.57|0.03|||Mixed Models Analysis|||||0.03|-0.57|0.074
73814917|NCT03334422|147179219|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.011|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Models Analysis|||||-0.09|-0.68|0.011
73814918|NCT03334422|147179219|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.84|-0.26|||Mixed Models Analysis|||||-0.26|-0.84|<0.001
73814919|NCT03334422|147179220|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.41||0.58|TWO_SIDED|95.0|-1.05|0.59|||Mixed Models Analysis|||||0.59|-1.05|0.580
73814920|NCT03334422|147179220|SUPERIORITY||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.54|-0.96|||Mixed Models Analysis|||||-0.96|-2.54|<0.001
73814921|NCT03334422|147179220|SUPERIORITY||Mean Difference (Net)|-1.62|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.37|-0.87|||Mixed Models Analysis|||||-0.87|-2.37|<0.001
73814922|NCT03334422|147179221|SUPERIORITY||Odds Ratio (OR)|1.67||||0.094|TWO_SIDED|95.0|0.92|3.04|||Regression, Logistic|||||3.04|0.92|0.094
73814923|NCT03334422|147179221|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|1.65|5.11|||Regression, Logistic|||||5.11|1.65|<0.001
73814924|NCT03334422|147179221|SUPERIORITY||Odds Ratio (OR)|3.15|||<|0.001|TWO_SIDED|95.0|1.8|5.51|||Regression, Logistic|||||5.51|1.80|<0.001
73814925|NCT03334422|147179222|SUPERIORITY||Odds Ratio (OR)|1.57||||0.528|TWO_SIDED|95.0|0.39|6.31|||Regression, Logistic|||||6.31|0.39|0.528
73814926|NCT03334422|147179222|SUPERIORITY||Odds Ratio (OR)|2.56||||0.142|TWO_SIDED|95.0|0.73|8.95|||Regression, Logistic|||||8.95|0.73|0.142
73814927|NCT03334422|147179222|SUPERIORITY||Odds Ratio (OR)|2.68||||0.123|TWO_SIDED|95.0|0.77|9.37|||Regression, Logistic|||||9.37|0.77|0.123
73814928|NCT03334422|147179223|SUPERIORITY||LSMean Difference|-6.88|STANDARD_ERROR_OF_MEAN|3.63||0.059|TWO_SIDED|95.0|-14.03|0.28|||Mixed Models Analysis|||||0.28|-14.03|0.059
73814929|NCT03334422|147179223|SUPERIORITY||LSMean Difference|-14.48|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|-21.32|-7.63|||Mixed Models Analysis|||||-7.63|-21.32|<0.001
73814930|NCT03334422|147179223|SUPERIORITY||LSMean Difference|-14.15|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-20.69|-7.61|||Mixed Models Analysis|||||-7.61|-20.69|<0.001
73814931|NCT03334422|147179224|SUPERIORITY||Odds Ratio (OR)|2.55||||0.193|TWO_SIDED|95.0|0.62|10.45|||Regression, Logistic|||||10.45|0.62|0.193
73814932|NCT03334422|147179224|SUPERIORITY||Odds Ratio (OR)|4.1||||0.042|TWO_SIDED|95.0|1.05|16.03|||Mixed Models Analysis|||||16.03|1.05|0.042
73814933|NCT03334422|147179224|SUPERIORITY||Odds Ratio (OR)|3.89||||0.044|TWO_SIDED|95.0|1.04|14.57|||Regression, Logistic|||||14.57|1.04|0.044
73814934|NCT03334422|147179225|SUPERIORITY||LSMean Difference|-6.16|STANDARD_ERROR_OF_MEAN|3.23||0.058|TWO_SIDED|95.0|-12.53|0.21|||Mixed Models Analysis|||||0.21|-12.53|0.058
73814935|NCT03334422|147179225|SUPERIORITY||LSMean Difference|-9.3|STANDARD_ERROR_OF_MEAN|3.1||0.003|TWO_SIDED|95.0|-15.42|-3.18|||Mixed Models Analysis|||||-3.18|-15.42|0.003
73814936|NCT03334422|147179225|SUPERIORITY||LSMean Difference|-11.16|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-17.03|-5.3|||Mixed Models Analysis|||||-5.30|-17.03|<0.001
73814937|NCT03334422|147179226|SUPERIORITY|||||||0.189|||||||Fisher Exact|||||||0.189
73814938|NCT03334422|147179226|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
73814939|NCT03334422|147179226|SUPERIORITY|||||||0.383|||||||Fisher Exact|||||||0.383
73814940|NCT03334422|147179227|SUPERIORITY||LSMean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.46||0.081|TWO_SIDED|95.0|-31.45|1.85|||Mixed Models Analysis|||||1.85|-31.45|0.081
73814941|NCT03334422|147179227|SUPERIORITY||LSMean Difference|-30.66|STANDARD_ERROR_OF_MEAN|8.11|<|0.001|TWO_SIDED|95.0|-46.62|-14.7|||Mixed Models Analysis|||||-14.70|-46.62|<0.001
73814942|NCT03334422|147179227|SUPERIORITY||LSMean Difference|-30.28|STANDARD_ERROR_OF_MEAN|7.63|<|0.001|TWO_SIDED|95.0|-45.29|-15.27|||Mixed Models Analysis|||||-15.27|-45.29|<0.001
73814943|NCT03334422|147179228|SUPERIORITY||LSMean Difference|-2.36|STANDARD_ERROR_OF_MEAN|1.32||0.075|TWO_SIDED|95.0|-4.97|0.24|||Mixed Models Analysis|||||0.24|-4.97|0.075
73814944|NCT03334422|147179228|SUPERIORITY||LSMean Difference|-5.58|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-8.07|-3.08|||Mixed Models Analysis|||||-3.08|-8.07|<0.001
73814945|NCT03334422|147179228|SUPERIORITY||LSMean Difference|-6.07|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-8.47|-3.68|||Mixed Models Analysis|||||-3.68|-8.47|<0.001
73814946|NCT03334422|147179229|SUPERIORITY||LSMean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.13|TWO_SIDED|95.0|-0.61|0.08|||Mixed Models Analysis|||||0.08|-0.61|0.130
73814947|NCT03334422|147179229|SUPERIORITY||LSMean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.94|-0.28|||Mixed Models Analysis|||||-0.28|-0.94|<0.001
73814948|NCT03334422|147179229|SUPERIORITY||LSMean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.0|-0.38|||Mixed Models Analysis|||||-0.38|-1.00|<0.001
73814949|NCT03334422|147179230|SUPERIORITY||LSMean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.51||0.067|TWO_SIDED|95.0|-1.95|0.07|||Mixed Models Analysis|||HADS Anxiety.||0.07|-1.95|0.067
73814950|NCT03334422|147179230|SUPERIORITY||LSMean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.49||0.06|TWO_SIDED|95.0|-1.89|0.04|||Mixed Models Analysis|||HADS Anxiety.||0.04|-1.89|0.060
73814951|NCT03334422|147179230|SUPERIORITY||LSMean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.47||0.006|TWO_SIDED|95.0|-2.23|-0.38|||Mixed Models Analysis|||HADS Anxiety.||-0.38|-2.23|0.006
73814952|NCT03334422|147179230|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.321|TWO_SIDED|95.0|-1.5|0.49|||Mixed Models Analysis|||HADS Depression.||0.49|-1.50|0.321
73814953|NCT03334422|147179230|SUPERIORITY||LSMean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.49||0.143|TWO_SIDED|95.0|-1.67|0.24|||Mixed Models Analysis|||HADS Depression.||0.24|-1.67|0.143
73814954|NCT03334422|147179230|SUPERIORITY||LSMean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.47||0.012|TWO_SIDED|95.0|-2.11|-0.26|||Mixed Models Analysis|||HADS Depression.||-0.26|-2.11|0.012
73814955|NCT03334422|147179231|SUPERIORITY||LSMean Difference|-1.76|STANDARD_ERROR_OF_MEAN|0.97||0.071|TWO_SIDED|95.0|-3.67|0.15|||Mixed Models Analysis|||||0.15|-3.67|0.071
73814956|NCT03334422|147179231|SUPERIORITY||LSMean Difference|-4.09|STANDARD_ERROR_OF_MEAN|0.93|<|0.001|TWO_SIDED|95.0|-5.92|-2.26|||Mixed Models Analysis|||||-2.26|-5.92|<0.001
73814957|NCT03334422|147179231|SUPERIORITY||LSMean Difference|-4.22|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.98|-2.45|||Mixed Models Analysis|||||-2.45|-5.98|<0.001
73814958|NCT03334422|147179232|SUPERIORITY||LSMean Difference|-0.91|STANDARD_ERROR_OF_MEAN|5.17||0.861|TWO_SIDED|95.0|-11.16|9.34|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||9.34|-11.16|0.861
73814959|NCT03334422|147179232|SUPERIORITY||LSMean Difference|1.01|STANDARD_ERROR_OF_MEAN|5.03||0.841|TWO_SIDED|95.0|-8.94|10.97||Absenteeism|Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||10.97|-8.94|0.841
73814960|NCT03334422|147179232|SUPERIORITY||LSMean Difference|5.16|STANDARD_ERROR_OF_MEAN|4.6||0.264|TWO_SIDED|95.0|-3.95|14.26|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||14.26|-3.95|0.264
73814961|NCT03334422|147179232|SUPERIORITY||LSMean Difference|-3.12|STANDARD_ERROR_OF_MEAN|5.63||0.58|TWO_SIDED|95.0|-14.26|8.02|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||8.02|-14.26|0.580
73814962|NCT03334422|147179232|SUPERIORITY||LSMean Difference|-13.56|STANDARD_ERROR_OF_MEAN|5.5||0.015|TWO_SIDED|95.0|-24.45|-2.86|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-2.86|-24.45|0.015
73814963|NCT03334422|147179232|SUPERIORITY||LSMean Difference|-13.13|STANDARD_ERROR_OF_MEAN|5.08||0.011|TWO_SIDED|95.0|-23.2|-3.06|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-3.06|-23.20|0.011
73814964|NCT03334422|147179232|SUPERIORITY||LSMean Difference|-1.81|STANDARD_ERROR_OF_MEAN|6.71||0.788|TWO_SIDED|95.0|-15.12|11.49|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||11.49|-15.12|0.788
73814965|NCT03334422|147179232|SUPERIORITY||LSMean Difference|-9.48|STANDARD_ERROR_OF_MEAN|6.57||0.152|TWO_SIDED|95.0|-22.51|3.55|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||3.55|-22.51|0.152
73814966|NCT03334422|147179232|SUPERIORITY|Overall Work Impairment|LSMean Difference|-9.13|STANDARD_ERROR_OF_MEAN|6.07||0.135|TWO_SIDED|95.0|-21.17|2.9|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||2.90|-21.17|0.135
73814967|NCT03334422|147179232|SUPERIORITY||LSMean Difference|-2.26|STANDARD_ERROR_OF_MEAN|4.25||0.595|TWO_SIDED|95.0|-10.65|6.12|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||6.12|-10.65|0.595
73814968|NCT03334422|147179232|SUPERIORITY||LSMean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-22.43|-6.17|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-6.17|-22.43|<0.001
73814969|NCT03334422|147179232|SUPERIORITY||LSMean Difference|-14.47|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-22.11|-6.83|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-6.83|-22.11|<0.001
73814970|NCT03334422|147179233|SUPERIORITY||LSMean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.295|TWO_SIDED|95.0|-0.02|0.07|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.07|-0.02|0.295
73814971|NCT03334422|147179233|SUPERIORITY||LSMean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.02||0.001|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.12|0.03|0.001
73814972|NCT03334422|147179233|SUPERIORITY||LSMean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.12|0.03|<0.001
73814973|NCT03334422|147179233|SUPERIORITY||LSMean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.334|TWO_SIDED|95.0|-0.03|0.1|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.10|-0.03|0.334
73814974|NCT03334422|147179233|SUPERIORITY||LSMean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.03||0.001|TWO_SIDED|95.0|0.04|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.17|0.04|0.001
73814975|NCT03334422|147179233|SUPERIORITY||LSMean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.05|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.17|0.05|<0.001
73814976|NCT03334422|147179234|SUPERIORITY||LSMean Difference|0.4|STANDARD_ERROR_OF_MEAN|3.47||0.907|TWO_SIDED|95.0|-6.44|7.25|||Mixed Models Analysis|||EQ-5D-5L VAS Score||7.25|-6.44|0.907
73814977|NCT03334422|147179234|SUPERIORITY||LSMean Difference|8.19|STANDARD_ERROR_OF_MEAN|3.33||0.015|TWO_SIDED|95.0|1.63|14.76|||Mixed Models Analysis|||EQ-5D-5L VAS Score||14.76|1.63|0.015
73814978|NCT03334422|147179234|SUPERIORITY||LSMean Difference|8.82|STANDARD_ERROR_OF_MEAN|3.14||0.006|TWO_SIDED|95.0|2.62|15.01|||Mixed Models Analysis|||EQ-5D-5L VAS Score||15.01|2.62|0.006
73814979|NCT03334422|147179235|SUPERIORITY||Odds Ratio (OR)|0.93||||0.905|TWO_SIDED|95.0|0.3|2.93|||Regression, Logistic|||||2.93|0.30|0.905
73814980|NCT03334422|147179235|SUPERIORITY||Odds Ratio (OR)|2.37||||0.064|TWO_SIDED|95.0|0.95|5.92|||Regression, Logistic|||||5.92|0.95|0.064
73814981|NCT03334422|147179235|SUPERIORITY||Odds Ratio (OR)|5.14|||<|0.001|TWO_SIDED|95.0|2.25|11.74|||Regression, Logistic|||||11.74|2.25|<0.001
73814982|NCT01313221|147179248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.16|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-3.5|35.82|||||Adjusted for treatment in a mixed model|||35.82|-3.50|
73814983|NCT01313221|147179249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.23|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|95.0|-5.13|27.6||||||Difference in change from Week 12 to Week 16||27.60|-5.13|
73814984|NCT01313221|147179249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.56|STANDARD_ERROR_OF_MEAN|9.53|||TWO_SIDED|95.0|-2.21|35.32||||||Difference in change from Week 12 to Week 20||35.32|-2.21|
73814985|NCT02509078|147179292|SUPERIORITY||Risk Difference (RD)|-0.3||||0.93|TWO_SIDED|95.0|-6.4|5.9|||Wald test for the difference of two prop||Estimated value is a percentage|||5.9|-6.4|0.93
73814986|NCT00253370|147179308|SUPERIORITY_OR_OTHER||proportion of participants|0.409||||0.0012|TWO_SIDED|90.0|0.284|0.544|||one-sample binomial test|||The study was designed to distinguish a response rate of 40% from 20%, the null hypothesis. With the planned sample size of 36 eligible patients, the study has 91% power based on a 0.09 level one-sided test.||0.544|0.284|0.0012
73814987|NCT00904839|147179326|SUPERIORITY_OR_OTHER||Difference|-8.1|||||TWO_SIDED|95.0|-27.8|11.5|||Kaplan-Meier||Difference in Kaplan-Meier Progression-free Survival Rates at 9 Months using Peto´s variance estimate.|||11.5|-27.8|
73814988|NCT00904839|147179331|SUPERIORITY_OR_OTHER||Difference|-5.0|||||TWO_SIDED|95.0|-15.3|5.2|||Kaplan-Meier||confidence interval includes 0, meaning that the null hypothesis (no difference between the 2 groups) cannot be rejected (i.e. pvalue \> 0.05). The pvalue was not computed. Difference in Kaplan-Meier Resection Rates using Peto´s variance estimate.|||5.2|-15.3|
73814989|NCT00553358|147179344|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with pCR|-4.85||||0.3416|TWO_SIDED|97.5|-17.6|8.16|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1500 mg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm1 (Lapatinib 1500 mg) minus Arm2 (Trastuzumab 2 mg/kg).|||8.16|-17.6|0.3416
73814990|NCT00553358|147179344|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with pCR|21.79||||0.0001|TWO_SIDED|97.5|9.08|34.23|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm3 (Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg) minus Arm2 (Trastuzumab 2 mg/kg)|||34.23|9.08|0.0001
73814991|NCT00553358|147179352|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878||||0.548|TWO_SIDED|95.0|0.57|1.34||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.34|0.57|0.548
73814992|NCT00553358|147179352|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.005||||0.981|TWO_SIDED|95.0|0.66|1.52||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.52|0.66|0.981
73814993|NCT00553358|147179354|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.788||||0.379|TWO_SIDED|95.0|0.46|1.34||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.34|0.46|0.379
73814994|NCT00553358|147179354|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.962||||0.88|TWO_SIDED|95.0|0.58|1.6||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.60|0.58|0.880
73814995|NCT00553358|147179355|SUPERIORITY||Hazard Ratio (HR)|0.481||||0.00079|TWO_SIDED|95.0|0.31|0.73|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Overall - All subjects in the EFS landmark analysis||0.73|0.31|0.00079
73814996|NCT00553358|147179355|SUPERIORITY||Hazard Ratio (HR)|0.35||||0.004|TWO_SIDED|95.0|0.16|0.71|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the lapatinib + trastuzumab arm||0.71|0.16|0.004
73814997|NCT00553358|147179355|SUPERIORITY||Hazard Ratio (HR)|0.532||||0.134|TWO_SIDED|95.0|0.21|1.16|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the lapatinib arm||1.16|0.21|0.134
73814998|NCT00553358|147179355|SUPERIORITY||Hazard Ratio (HR)|0.601||||0.163|TWO_SIDED|95.0|0.28|1.2|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the trastuzumab arm||1.20|0.28|0.163
73814999|NCT00553358|147179357|SUPERIORITY||Hazard Ratio (HR)|0.366||||0.00041|TWO_SIDED|95.0|0.2|0.63|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Overall - All subjects in the OS landmark analysis||0.63|0.20|0.00041
73815000|NCT00553358|147179357|SUPERIORITY||Hazard Ratio (HR)|0.223||||0.002|TWO_SIDED|95.0|0.07|0.58|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the lapatinib + trastuzumab arm||0.58|0.07|0.002
73815001|NCT00553358|147179357|SUPERIORITY||Hazard Ratio (HR)|0.433||||0.125|TWO_SIDED|95.0|0.12|1.17|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the lapatinib arm||1.17|0.12|0.125
73815002|NCT00553358|147179357|SUPERIORITY||Hazard Ratio (HR)|0.414||||0.058|TWO_SIDED|95.0|0.15|1.0|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the trastuzumab arm||1.00|0.15|0.058
73815003|NCT03887429|147179395|SUPERIORITY||||||=|0.009|||||||t-test, 1 sided|||It was hypothesized that treatment with SXC-2023 would reduce impulsivity as measured by SSRT in chronic cigarette smokers abstaining from nicotine for 5 days.||||=.009
73815004|NCT03887429|147179396|SUPERIORITY||||||=|0.015|||||||t-test, 1 sided|||It was hypothesized that 5 days of nicotine abstinence in chronic cigarette smokers would result in increased risk taking behavior as measured using DAVT in subjects receiving placebo as treatment.||||=.015
73815005|NCT03887429|147179396|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||It was hypothesized that 5 days of nicotine abstinence in chronic cigarette smokers would not result in increased risk taking behavior as measured using DAVT in subjects treated with SXC-2023.||||>.1
73815006|NCT00187278|147179407|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.926||||0.3492|TWO_SIDED|95.0|0.789|1.0088||adjusted p|Regression, Cox|||||1.0088|0.789|0.3492
73815007|NCT00187278|147179408|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878||||0.0882|TWO_SIDED|95.0|0.756|1.02||adjusted p|Regression, Cox|||||1.020|0.756|0.0882
73815008|NCT00187278|147179409|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.8215|TWO_SIDED|95.0|0.74|1.27|||Regression, Cox|||||1.27|0.74|0.8215
73815009|NCT00803205|147179424|SUPERIORITY|||||||0.3264|||||||ANOVA|||||||0.3264
73815010|NCT00803205|147179425|SUPERIORITY||Mean Difference (Final Values)|2.754|STANDARD_ERROR_OF_MEAN|1.78124||0.1235|TWO_SIDED|95.0|-0.756|6.264||The p-value is the LS-mean for the comparison between active treatment and placebo. The level of significance was 0.04998.|Mixed Models Analysis|||Least squares (LS) mean estimates based on mixed model for repeated measures (Weeks 8, 16, 24, 32, 40 and 48) of relative change in percent-predicted FEV1 as the dependent variable; independent variables including Baseline percent-predicted FEV1, treatment, visit, interactions between treatment and visit and between Baseline percent-predicted FEV1 and visit; and stratification factors of Baseline age, Baseline inhaled antibiotics, and Baseline percent-predicted FEV1.||6.2640|-0.7560|0.1235
73815011|NCT00379808|147179458|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.22|||||||Wilcoxon sign rank test|||Statistical power was calculated using G\*Power (Dusseldorf, Germany). Based on previously observed effects of statin drugs on hsCRP levels, 22 subjects provided 80% power to detect a moderate effect on hsCRP levels.||||0.22
73815012|NCT00379808|147179459|SUPERIORITY_OR_OTHER||percent difference|3.8||||0.57|||||||Wilcoxon sign rank|||Null hypothesis is that montelukast does not affect HDL. Not powered for this endpoint||||0.57
73815013|NCT00379808|147179460|SUPERIORITY_OR_OTHER||percent difference|7.4||||0.33|||||||wilcoxon sign rank|||The null hypothesis is that montelukast does not affect triglycerides. The study was not powered to this outcome measure.||||0.33
73815014|NCT00379808|147179461|SUPERIORITY_OR_OTHER||percent difference|11.9||||0.12|||||||Wilcoxon|||null hypothesis is that montelukast does not affect MCP-1. Study not powered to the biomarker.||||0.12
73815015|NCT00379808|147179462|SUPERIORITY_OR_OTHER||percent difference|13.3||||0.03|||||||wilcoxon sign rank test|||null hypothesis is that montelukast does not affect IL1ra.||||0.03
73815016|NCT00379808|147179463|SUPERIORITY_OR_OTHER||percent difference|16.5||||0.09|||||||wilcoxon sign rank|||null hypothesis is that montelukast does not affect ENA-78. The study is not powered to this biomarker||||0.09
73815017|NCT01432561|147179464|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||High-fat/calorie compared to fasted condition||||.04
73815018|NCT01432561|147179464|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANOVA|||High-protein compared to fasted condition||||.005
73815019|NCT01432561|147179465|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||High-fat/calorie compared to fasted condition||||.16
73815020|NCT01432561|147179465|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANOVA|||High-protein compared to fasted condition||||.036
73815021|NCT01432561|147179466|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Non-parametric Hodges-Lehmann method|||Fed high-fat/calorie compared to fasted condition.||||.30
73815022|NCT01432561|147179466|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Non-parametric Hodges-Lehmann method|||High-protein compared to fasted condition||||.05
73815023|NCT00508157|147179491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.28|||||TWO_SIDED|95.0|-19.14|-2.66|||ANCOVA|ANCOVA model: log of on-treatment to baseline ratio = log of baseline value, treatment, previous antipsychotic.|Relative difference of Aripiprazole vs. Control Group in terms of (mean % change from baseline/100)+1.|Null hypothesis: no difference in mean percent change from baseline in fasting non-HDLC between aripiprazole and the control group at Week 16||-2.66|-19.14|
73815024|NCT00508157|147179492|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.54|1.06|||Cochran-Mantel-Haenszel|A relative risk \< 1 favors Aripiprazole over Control Group.||null hypothesis: no difference between Aripiprazole and Control Group||1.06|0.54|
73815025|NCT02069093|147179500|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Incidence rate R|||A test of the incidence rate R was performed with null hypothesis H0: R\>= 0.33 and alternative hypothesis Ha: R\<0.33 with a one-sided significance level of 0.05. If the test statistic was negative (actual incidence rate was \<0.33), the one-sided p-value for the null hypothesis R\>=0.33 was presented. The null hypothesis was rejected if the statistic was negative and the corresponding p-value for the one-sided test was \<0.5.||||<0.001
73815026|NCT02240069|147179546|SUPERIORITY||Mean Difference (Net)|-0.11||||0.1|TWO_SIDED|95.0|-0.24|0.02|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1 for Education group relative to Placebo group||0.02|-0.24|0.10
73815027|NCT02240069|147179546|SUPERIORITY||Mean Difference (Net)|0.01||||0.9|TWO_SIDED|95.0|-0.11|0.13|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1 for Filtration group relative to Placebo group||0.13|-0.11|0.90
73815028|NCT02240069|147179547|SUPERIORITY||Mean Difference (Net)|-0.09||||0.28|TWO_SIDED|95.0|-0.24|0.07|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FVC for Education group relative to Placebo group||0.07|-0.24|0.28
73815029|NCT02240069|147179547|SUPERIORITY||Mean Difference (Net)|0.01||||0.89|TWO_SIDED|95.0|-0.14|0.16|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FVC for Filter group relative to Placebo group||0.16|-0.14|0.89
73815030|NCT02240069|147179548|SUPERIORITY||Mean Difference (Net)|-0.02||||0.06|TWO_SIDED|95.0|-0.05|0.0|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1/FVC for Education group relative to Placebo group||0.00|-0.05|0.06
73815031|NCT02240069|147179548|SUPERIORITY||Mean Difference (Net)|0.0||||0.71|TWO_SIDED|95.0|-0.03|0.02|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1/FVC for Filter group relative to Placebo group||0.02|-0.03|0.71
73815032|NCT02240069|147179549|SUPERIORITY||Mean Difference (Net)|-3.46||||0.39|TWO_SIDED|95.0|-11.45|4.54|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in systolic blood pressure for Education group relative to Placebo group||4.54|-11.45|0.39
73815033|NCT02240069|147179549|SUPERIORITY||Mean Difference (Net)|0.25||||0.95|TWO_SIDED|95.0|-7.73|8.24|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in systolic blood pressure for Filter group relative to Placebo group||8.24|-7.73|0.95
73815034|NCT02240069|147179550|SUPERIORITY||Mean Difference (Net)|-1.0||||0.65|TWO_SIDED|95.0|-5.42|3.42|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in diastolic blood pressure for Education group relative to Placebo group||3.42|-5.42|0.65
73815035|NCT02240069|147179550|SUPERIORITY||Mean Difference (Net)|-0.58||||0.79|TWO_SIDED|95.0|-4.97|3.81|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in diastolic blood pressure for Filter group relative to Placebo group||3.81|-4.97|0.79
73815036|NCT02240069|147179551|SUPERIORITY||Mean Difference (Net)|-2.9||||0.88|TWO_SIDED|95.0|-33.6|42.0|||Mixed Models Analysis|Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.||Pre- to post-intervention change in indoor PM2.5 concentration for Education group relative to Placebo group||42.0|-33.6|0.88
73815037|NCT02240069|147179551|SUPERIORITY||Mean Difference (Net)|-50.5|||<|0.001|TWO_SIDED|95.0|-66.1|-27.8|||Mixed Models Analysis|Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.||Pre- to post-intervention change in indoor PM2.5 concentration for Filter group relative to Placebo group||-27.8|-66.1|<0.001
73815038|NCT00474786|147179557|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.1933|TWO_SIDED|95.0|0.71|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (\<) 1 means temsirolimus (TEMSR) is at lower risk.|||1.07|0.71|0.1933
73815039|NCT00474786|147179558|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.1888|TWO_SIDED|95.0|0.7|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (\<) 1 means temsirolimus (TEMSR) is at lower risk.|||1.07|0.70|0.1888
73815040|NCT00474786|147179560|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.31||||0.0144|TWO_SIDED|95.0|1.05|1.63||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and MSKCC prognostic group.|Log Rank||Hazard ratio \<1 means temsirolimus (TEMSR) is at lower risk.|||1.63|1.05|0.0144
73815041|NCT03646305|147179567|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental,control) × 2(Activity: singing,verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, believability of thought were equivalent across time||||<0.001
73815042|NCT03646305|147179567|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in believability of thought from baseline to post-intervention. Null hypothesis: there would be no significant difference in believability of thought from baseline to post-intervention||||<0.001
73815043|NCT03646305|147179567|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences from post-intervention to follow-up. Null hypothesis: there would be no significant differences in believability of thought from post-intervention to follow-up.||||<0.001
73815044|NCT03646305|147179567|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal believability scores||||>0.05
73815045|NCT03646305|147179567|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal believability scores||||>0.05
73815046|NCT03646305|147179567|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in believability scores||||>0.05
73815047|NCT03646305|147179567|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions have equivalent believability scores across time.||||>0.05
73815048|NCT03646305|147179567|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on believability scores||||>0.05
73815049|NCT03646305|147179567|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no significant difference between 4 conditions on believability||||>0.05
73815050|NCT03646305|147179568|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, appraisal of target thought were equivalent across time.||||<0.001
73896465|NCT00913458|147326228|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
73896466|NCT00913458|147326229|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
73896467|NCT00913458|147326230|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
73815051|NCT03646305|147179568|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.005|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent across time.||||=0.005
73815052|NCT03646305|147179568|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.002|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from baseline to post-intervention. Null hypothesis: the control conditions would have no significant difference in negativity from baseline to post-intervention||||=0.002
73815053|NCT03646305|147179568|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from post-intervention to follow-up. Null hypothesis: the control conditions would have no significant difference in negativity from post-intervention to follow-up.||||<0.001
73815054|NCT03646305|147179568|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.025|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in negativity from baseline to post-intervention. Null hypothesis: there would be no significant difference in negativity scores from baseline to post-intervention in the experimental conditions||||>0.025
73815055|NCT03646305|147179568|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.025|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from post-intervention to follow-up. Null hypothesis: the experimental conditions would have no significant difference in negativity scores from post-intervention to follow-up.||||>0.025
73815056|NCT03646305|147179568|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal negativity scores||||>0.05
73815057|NCT03646305|147179568|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal negativity scores||||>0.05
73815058|NCT03646305|147179568|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in negativity scores||||>0.05
73896468|NCT00913458|147326231|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
73896469|NCT00913458|147326232|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
73896470|NCT00913458|147326233|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
73815059|NCT03646305|147179568|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on negativity scores||||>0.05
73815060|NCT03646305|147179568|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on negativity scores||||>0.05
73815061|NCT03646305|147179569|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at p\< .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of discomfort were equivalent across time.||||<0.001
73815062|NCT03646305|147179569|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in levels of discomfort from baseline to post-intervention. Null hypothesis: there would have no significant differences in discomfort levels from baseline to post-intervention across samples||||<0.001
73815063|NCT03646305|147179569|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in levels of discomfort from post-intervention to follow-up. Null hypothesis: there would be no significant differences in discomfort levels from post-intervention to follow-up across samples||||<0.001
73815064|NCT03646305|147179569|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of discomfort||||>0.05
73815065|NCT03646305|147179569|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of discomfort||||>0.05
73896471|NCT00913458|147326234|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
73896472|NCT00913458|147326235|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||McNemar|||"P-value is from McNemar's test for no change from baseline in response rate.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
73815066|NCT03646305|147179569|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of discomfort||||>0.05
73815067|NCT03646305|147179569|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of discomfort across time||||>0.05
73815068|NCT03646305|147179569|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of discomfort||||>0.05
73815069|NCT03646305|147179569|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no significant difference between 4 conditions on discomfort levels||||>0.05
73815070|NCT03646305|147179570|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, willingness to engage with target thought were equivalent across time||||<0.001
73815071|NCT03646305|147179570|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in willingness to engage with target thought from baseline to post-intervention. Null hypothesis: there would be no difference in willingness scores from baseline to post-intervention||||<0.001
73815072|NCT03646305|147179570|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.053|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in willingness to engage with target thought from post-intervention to follow-up. Null hypothesis: there would be no significant difference in willingness scores from post-intervention to follow-up.||||=0.053
73896473|NCT00913458|147326236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.4075|TWO_SIDED|95.0|0.4|7.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.6|0.4|0.4075
73815073|NCT03646305|147179570|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal willingness scores||||>0.05
73815074|NCT03646305|147179570|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal willingness to engage with the target thought||||>0.05
73815075|NCT03646305|147179570|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in willingness to engage||||>0.05
73815076|NCT03646305|147179570|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in willingness to engage with the target thought across time.||||>0.05
73815077|NCT03646305|147179570|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on willingness to engage||||>0.05
73815078|NCT03646305|147179570|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on willingness to engage||||>0.05
73815079|NCT03646305|147179571|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.01|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, avoidance of target thought were equivalent across time||||<0.01
73896474|NCT00913458|147326236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.88||||0.0011|TWO_SIDED|95.0|2.4|33.1|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||33.1|2.4|0.0011
73896475|NCT00913458|147326236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87||||0.0031|TWO_SIDED|95.0|1.7|13.9|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||13.9|1.7|0.0031
73815080|NCT03646305|147179571|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in avoidance of target thought from baseline to post-intervention. Null hypothesis: there would be no significant differences in avoidance from baseline to post-intervention||||>0.05
73815081|NCT03646305|147179571|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||<|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in avoidance of target thought from post-intervention to follow-up. Null hypothesis: there would be no significant differences in avoidance from post-intervention to follow-up.||||<0.05
73815082|NCT03646305|147179571|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would show equal avoidance of target thought||||>0.05
73815083|NCT03646305|147179571|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal avoidance of target thought||||>0.05
73815084|NCT03646305|147179571|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in avoidance of target thought||||>0.05
73815085|NCT03646305|147179571|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in avoidance of target thought across time.||||>0.05
73815086|NCT03646305|147179571|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on avoidance of target thought||||>0.05
73815087|NCT03646305|147179571|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on avoidance of target thought||||>0.05
73815088|NCT03646305|147179572|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, cognitive delusion were equivalent across time||||>0.05
73815089|NCT03646305|147179572|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of cognitive defusion||||>0.05
73815090|NCT03646305|147179572|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of cognitive defusion||||>0.05
73815091|NCT03646305|147179572|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of cognitive defusion||||>0.05
73815092|NCT03646305|147179572|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of cognitive defusion across time.||||>0.05
73815093|NCT03646305|147179572|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of cognitive defusion||||>0.05
73896476|NCT00913458|147326237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.5951|TWO_SIDED|95.0|0.3|2.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.0|0.3|0.5951
73896477|NCT00913458|147326237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0934|TWO_SIDED|95.0|0.9|5.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.5|0.9|0.0934
73815094|NCT03646305|147179572|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on levels of cognitive defusion||||>0.05
73815095|NCT03646305|147179573|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, weight dissatisfaction were equivalent across time.||||<0.001
73815096|NCT03646305|147179573|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in weight dissatisfaction from baseline to post-intervention. Null hypothesis: there would be no significant differences in weight dissatisfaction from baseline to post-intervention||||<0.001
73815097|NCT03646305|147179573|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in weight dissatisfaction from post-intervention to follow-up. Null: there would be no differences in weight dissatisfaction from post-intervention to follow-up||||<0.05
73815098|NCT03646305|147179573|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal weight dissatisfaction||||>0.05
73815099|NCT03646305|147179573|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal weight dissatisfaction scores||||>0.05
73815100|NCT03646305|147179573|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in weight dissatisfaction||||>0.05
73815101|NCT03646305|147179573|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in weight dissatisfaction across time.||||>0.05
73815102|NCT03646305|147179573|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on weight dissatisfaction||||>0.05
73815103|NCT03646305|147179573|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on weight dissatisfaction||||>0.05
73815104|NCT03646305|147179574|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, appearance dissatisfaction were equivalent across time.||||<0.001
73815105|NCT03646305|147179574|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in appearance dissatisfaction from baseline to post-intervention. Null hypothesis: the control conditions would have no significant difference in appearance dissatisfaction from baseline to post-intervention||||>0.05
73815106|NCT03646305|147179574|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in appearance dissatisfaction from post-intervention to follow-up. Null hypothesis: the control conditions would have no significant difference in appearance dissatisfaction from post-intervention to follow-up.||||<0.001
73815107|NCT03646305|147179574|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal appearance dissatisfaction||||>0.05
73815108|NCT03646305|147179574|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal appearance dissatisfaction scores||||>0.05
73896478|NCT00913458|147326237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85||||0.0314|TWO_SIDED|95.0|1.1|7.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.4|1.1|0.0314
73896479|NCT00913458|147326238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6152|TWO_SIDED|95.0|0.5|2.8|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.8|0.5|0.6152
73815109|NCT03646305|147179574|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in appearance dissatisfaction||||>0.05
73815110|NCT03646305|147179574|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in appearance dissatisfaction across time.||||>0.05
73815111|NCT03646305|147179574|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on appearance dissatisfaction||||>0.05
73815112|NCT03646305|147179574|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on appearance dissatisfaction||||>0.05
73815113|NCT03646305|147179575|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, body state image satisfaction were equivalent across time||||<0.001
73815114|NCT03646305|147179575|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure the difference in state body image satisfaction from baseline to post intervention. Null hypothesis: there would be no significant differences in state body image satisfaction from baseline to post intervention.||||<0.05
73815115|NCT03646305|147179575|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure the difference in state body image satisfaction from post intervention to follow-up. Null hypothesis: there would be no significant differences in state body image satisfaction from post-intervention to follow-up.||||<0.001
73815116|NCT03646305|147179575|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal body state image satisfaction||||>0.05
73815117|NCT03646305|147179575|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal state body satisfaction scores||||>0.05
73815118|NCT03646305|147179575|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in state body image satisfaction||||>0.05
73815119|NCT03646305|147179575|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in state body image satisfaction across time.||||>0.05
73815120|NCT03646305|147179575|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on state body image satisfaction||||>0.05
73815121|NCT03646305|147179575|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on state body image satisfaction||||>0.05
73815122|NCT03646305|147179576|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, state body image satisfaction were equivalent across time.||||<0.001
73896480|NCT00913458|147326238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0432|TWO_SIDED|95.0|1.0|5.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.4|1.0|0.0432
73896481|NCT00913458|147326238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.1189|TWO_SIDED|95.0|0.8|4.3|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.3|0.8|0.1189
73896482|NCT00913458|147326239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.0535|TWO_SIDED|95.0|1.0|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.7|1.0|0.0535
73896483|NCT00913458|147326239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.22||||0.0064|TWO_SIDED|95.0|1.4|7.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.5|1.4|0.0064
73815123|NCT03646305|147179576|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in anxious mood from baseline to post-intervention. Null hypothesis: there would be no significant difference in anxious mood from baseline to post-intervention.||||<0.001
73815124|NCT03646305|147179576|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in anxious mood from post-intervention to follow-up. Null hypothesis: there would be no significant difference in anxious mood from post-intervention to follow-up||||>0.05
73815125|NCT03646305|147179576|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of anxiety||||>0.05
73815126|NCT03646305|147179576|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of anxiety||||>0.05
73815127|NCT03646305|147179576|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of anxiety||||>0.05
73815128|NCT03646305|147179576|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of anxiety across time||||>0.05
73815129|NCT03646305|147179576|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of anxiety||||>0.05
73815130|NCT03646305|147179576|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between the four conditions on levels of anxiety||||>0.05
73815131|NCT03646305|147179577|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of depressive mood were equivalent across time.||||<0.001
73815132|NCT03646305|147179577|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in depressive mood from depressive mood from baseline to post-intervention||||<0.001
73815133|NCT03646305|147179577|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in depressive mood from post-intervention to follow-up. Null hypothesis: there would be no significant differences in depressive mood from post-intervention to follow-up.||||>0.05
73815134|NCT03646305|147179577|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of depressive mood||||>0.05
73815135|NCT03646305|147179577|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of depressive mood||||>0.05
73815136|NCT03646305|147179577|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of depressive mood||||>0.05
73815137|NCT03646305|147179577|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of depressive mood across time||||>0.05
73815138|NCT03646305|147179577|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of depressive mood||||>0.05
73896484|NCT00913458|147326239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.3696|TWO_SIDED|95.0|0.6|3.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||3.6|0.6|0.3696
73815139|NCT03646305|147179577|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on levels of depressive mood||||>0.05
73815140|NCT03646305|147179578|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of happiness were equivalent across time||||>0.05
73815141|NCT03646305|147179578|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of happiness||||>0.05
73815142|NCT03646305|147179578|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of happiness||||>0.05
73815143|NCT03646305|147179578|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of happiness||||>0.05
73815144|NCT03646305|147179578|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of happiness across time.||||>0.05
73815145|NCT03646305|147179578|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of happiness||||>0.05
73896485|NCT00913458|147326240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0788|TWO_SIDED|95.0|0.9|5.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.2|0.9|0.0788
73896486|NCT00913458|147326240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57||||0.0007|TWO_SIDED|95.0|1.9|11.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||11.0|1.9|0.0007
73815146|NCT03646305|147179578|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of happiness||||>0.05
73815147|NCT03646305|147179579|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of confidence were equivalent across time.||||>0.05
73815148|NCT03646305|147179579|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of confidence||||>0.05
73815149|NCT03646305|147179579|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of confidence||||>0.05
73815150|NCT03646305|147179579|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of confidence||||>0.05
73815151|NCT03646305|147179579|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of confidence across time.||||>0.05
73815152|NCT03646305|147179579|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of happiness||||>0.05
73896487|NCT00913458|147326240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.0676|TWO_SIDED|95.0|0.9|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.7|0.9|0.0676
73896488|NCT00913458|147326241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.56||||0.0548|TWO_SIDED|95.0|1.0|59.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||59.5|1.0|0.0548
73815153|NCT03646305|147179579|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of happiness||||>0.05
73815154|NCT03646305|147179580|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, level of self-esteem were equivalent across time.||||<0.05
73815155|NCT03646305|147179580|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in self-esteem from post-intervention to follow-up. Null hypothesis: there would be no significant differences in self-esteem from post-intervention to follow-up.||||<0.001
73815156|NCT03646305|147179580|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of self-esteem||||>0.05
73815157|NCT03646305|147179580|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of self-esteem||||>0.05
73815158|NCT03646305|147179580|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions have equivalent levels of self-esteem||||>0.05
73815159|NCT03646305|147179580|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions have equivalent levels of self-esteem across time.||||>0.05
73815160|NCT03646305|147179580|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of self-esteem||||>0.05
73815161|NCT03646305|147179580|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of self-esteem||||>0.05
73815162|NCT03646305|147179581|OTHER|Mediation Analysis that examined whether greater homework adherence strengthened the relationship between condition and outcome|||||>|0.05|||||||Mediation Analyses|||All mediation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 4, which includes one outcome variable, one predictor, one mediator, and room for covariates. We examined the meditational effect of homework adherence on the relationship between intervention and each outcome measure. Null: homework adherence does not mediate any relationships between intervention condition and outcome measures.||||>0.05
73815163|NCT03646305|147179581|OTHER|Mediation Analysis that examined whether greater homework adherence strengthened the relationship between condition and outcome|||||>|0.05|||||||Mediation Analyses|||All mediation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 4, which includes one outcome variable, one predictor, one mediator, and room for covariates. We examined the meditational effect of homework adherence on the relationship between activity and each outcome measure. Null: homework adherence does not mediate any relationships between activity condition and outcome measures.||||>0.05
73815164|NCT03646305|147179582|OTHER|Thought-shape fusion was examined as a potential moderator of the relationship between intervention condition and outcome measures.|||||<|0.001||||||No other outcome measure was moderated by thought-shape fusion scores.|Moderation Analyses|||All moderation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 1, which includes one outcome variable, one predictor, and one moderator. Thought-shape fusion was examined as a potential moderator of the relationship between intervention condition and outcome measures. Null: thought-shape fusion does not significantly moderate the relationship between intervention condition and state self-esteem||||<0.001
73815165|NCT02195427|147179586|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Global Action and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|97.5|-0.17|0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Global Action versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."||0.11|-0.17|
73815166|NCT02195427|147179586|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Deep Lines and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|97.5|-0.25|0.06|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Deep Lines versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Deep Lines compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline"||0.06|-0.25|
73815167|NCT00207727|147179660|SUPERIORITY_OR_OTHER|||||||0||95.0||||The p-value was non estimable because the observed trend was in the opposite direction of that stated in the one sided alternative hypothesis|Jonckheere Terpstra|Jonckheere Terpstra nonparametric trend test procedure with 5% level of significance was be used to test for the monotonic trend.||Hypothesis: The null hypothesis of no effect among the treatment groups was tested against the alternative hypothesis that the cumulative number of newly Gd-enhancing T1-weighted lesions on cranial MRIs through Week 23 would decrease monotonically with dose at a significance level of 0.05.||||0.00
73815168|NCT00207727|147179661|SUPERIORITY_OR_OTHER|||||||0.892||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.892
73815169|NCT00207727|147179661|SUPERIORITY_OR_OTHER|||||||0.599||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.599
73815170|NCT00207727|147179661|SUPERIORITY_OR_OTHER|||||||0.517||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.517
73815171|NCT00207727|147179661|SUPERIORITY_OR_OTHER|||||||0.967||95.0|||||2-sided Wilcoxon Mann-Whitney|||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group.||||0.967
73815172|NCT00207727|147179662|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.720
73815173|NCT00207727|147179662|SUPERIORITY_OR_OTHER|||||||0.152||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.152
73815174|NCT00207727|147179662|SUPERIORITY_OR_OTHER|||||||0.431||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.431
73815175|NCT00207727|147179662|SUPERIORITY_OR_OTHER|||||||0.292||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group with placebo..||||0.292
73815176|NCT01653327|147179680|SUPERIORITY|||||||0.3198|||||||t-test, 2 sided|||||||0.3198
73815177|NCT01653327|147179681|SUPERIORITY|||||||0.3522|||||||t-test, 2 sided|||||||0.3522
73815178|NCT04607980|147179682|EQUIVALENCE|Clinical equivalence of the primary endpoint was evaluated by comparing the 2-sided 95% confidence interval (CI) of the mean difference of PASI percent improvement from Baseline to Week 12 between ABP 654 versus (vs) ustekinumab with an equivalence margin of (-15, +15).|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-3.16|3.43||||||Multiple imputation was applied for the point estimate and CI of the mean difference between the 2 groups.||3.43|-3.16|
73815179|NCT04607980|147179683|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using analysis of covariance (ANCOVA) model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.95|||||TWO_SIDED|95.0|-2.05|5.94||||||"Week 4: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||5.94|-2.05|
73815180|NCT04607980|147179683|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-2.97|3.31||||||"Week 16: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||3.31|-2.97|
73815181|NCT04607980|147179683|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|-1.39|4.07||||||"Week 28: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||4.07|-1.39|
73815182|NCT04607980|147179683|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|-5.46|7.98||||||"Week 36: Treatment Group A vs Treatment Group B.~Observed data was used."||7.98|-5.46|
73815183|NCT04607980|147179683|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-3.71|||||TWO_SIDED|95.0|-10.71|3.28||||||"Week 44: Treatment Group A vs Treatment Group B.~Observed data was used."||3.28|-10.71|
73815184|NCT04607980|147179683|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-8.45|7.13||||||"Week 52: Treatment Group A vs Treatment Group B.~Observed data was used."||7.13|-8.45|
73815185|NCT04607980|147179683|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-1.41|||||TWO_SIDED|95.0|-3.42|0.59||||||"Week 40: ABP 654 vs Ustekinumab.~LOCF imputation was used."||0.59|-3.42|
73815186|NCT04607980|147179683|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ustekinumab/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-3.17|1.48||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||1.48|-3.17|
73815187|NCT04607980|147179683|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.56|||||TWO_SIDED|95.0|-3.29|2.17||||||"Week 52: ABP 654 vs Ustekinumab.~LOCF imputation was used."||2.17|-3.29|
73815188|NCT04607980|147179683|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ustekinumab/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.46|3.86||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||3.86|-2.46|
73815189|NCT04607980|147179684|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.2|||||TWO_SIDED|95.0|-4.02|6.42||||||"Week 4: Treatment Group A vs Treatment Group B.~NRI was used."||6.42|-4.02|
73815190|NCT04607980|147179684|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-0.32|||||TWO_SIDED|95.0|-7.87|7.23||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||7.23|-7.87|
73815191|NCT04607980|147179684|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|0.82|||||TWO_SIDED|95.0|-5.75|7.37||||||"Week 16: Treatment Group A vs Treatment Group B.~NRI was used."||7.37|-5.75|
73815192|NCT04607980|147179684|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.75|||||TWO_SIDED|95.0|-2.37|9.84||||||"Week 28: Treatment Group A vs Treatment Group B.~NRI was used."||9.84|-2.37|
73815193|NCT04607980|147179684|EQUIVALENCE|Response difference in dose intensification participants (ABP 654 - ustekinumab) was estimated by the generalized linear model adjusted for the baseline PASI and the stratification factors with an identity link was used to obtain the point estimate and 95% CI for the risk difference of PASI 75 response rate at each scheduled timepoint.|Response difference|-3.19|||||TWO_SIDED|95.0|-28.15|21.76||||||"Week 36: Treatment Group A vs Treatment Group B.~Observed data was used."||21.76|-28.15|
73815194|NCT04607980|147179684|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.1|||||TWO_SIDED|95.0|-3.74|7.54||||||"Week 40: ABP 654 vs Ustekinumab.~NRI was used."||7.54|-3.74|
73815195|NCT04607980|147179684|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.85|||||TWO_SIDED|95.0|-4.89|8.39||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||8.39|-4.89|
73815196|NCT04607980|147179684|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-2.75|||||TWO_SIDED|95.0|-8.61|4.41||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||4.41|-8.61|
73815197|NCT04607980|147179684|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|0.14|||||TWO_SIDED|95.0|-7.32|7.43||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||7.43|-7.32|
73815198|NCT04607980|147179685|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-0.34|||||TWO_SIDED|95.0|-3.16|3.21||||||"Week 4: Treatment Group A vs Treatment Group B.~NRI was used."||3.21|-3.16|
73815199|NCT04607980|147179685|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.58|||||TWO_SIDED|95.0|-5.03|8.18||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||8.18|-5.03|
73815200|NCT04607980|147179685|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.81|||||TWO_SIDED|95.0|-3.62|11.17||||||"Week 16: Treatment Group A vs Treatment Group B.~NRI was used."||11.17|-3.62|
73815201|NCT04607980|147179685|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.07|||||TWO_SIDED|95.0|-4.68|10.78||||||"Week 28: Treatment Group A vs Treatment Group B.~NRI was used."||10.78|-4.68|
73815202|NCT04607980|147179685|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-1.93|||||TWO_SIDED|95.0|-12.85|8.89||||||"Week 40: ABP 654 vs Ustekinumab.~NRI was used."||8.89|-12.85|
73815203|NCT04607980|147179685|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-4.93|||||TWO_SIDED|95.0|-17.39|7.73||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||7.73|-17.39|
73815204|NCT04607980|147179685|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|2.55|||||TWO_SIDED|95.0|-8.42|13.3||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||13.30|-8.42|
73815205|NCT04607980|147179685|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-2.41|||||TWO_SIDED|95.0|-14.91|10.19||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||10.19|-14.91|
73815206|NCT04607980|147179686|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|2.55|||||TWO_SIDED|95.0|-5.65|10.71||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||10.71|-5.65|
73815207|NCT04607980|147179686|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-6.57|||||TWO_SIDED|95.0|-15.41|3.29||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||3.29|-15.41|
73815208|NCT04607980|147179686|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-7.46|||||TWO_SIDED|95.0|-18.41|3.74||||||"Week 52: ABP 654/Ustekinumab vs Ustekinumab.~NRI was used."||3.74|-18.41|
73815209|NCT04607980|147179687|EQUIVALENCE|Mean difference estimated for treatment group A and treatment group B using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-1.15|2.1||||||"Week 12: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||2.10|-1.15|
73815210|NCT04607980|147179687|EQUIVALENCE|Mean difference estimated in dose intensification participants (treatment group A and treatment group B) using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.39|||||TWO_SIDED|95.0|-0.9|3.67||||||"Week 52: Treatment Group A vs Treatment Group B.~Observed data was used."||3.67|-0.90|
73815211|NCT04607980|147179687|EQUIVALENCE|Mean difference estimated for ABP 654/ ABP 654 and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.13|||||TWO_SIDED|95.0|-0.99|0.74||||||"Week 52: ABP 654 vs Ustekinumab.~LOCF imputation was used."||0.74|-0.99|
73815212|NCT04607980|147179687|EQUIVALENCE|Mean difference estimated for ustekinumab/ABP 654 and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.9|1.1||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||1.10|-0.90|
73815213|NCT04767529|147179696|SUPERIORITY||percent difference|22.6||||0.025|TWO_SIDED|95.0|3.8|41.4||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparison between the EFX 28 mg and placebo group|% difference from placebo (efruxifermin 28 mg - placebo)|Comparison between proportion of participants in efruxifermin 28 mg group who met the primary endpoint vs the placebo group||41.4|3.8|0.025
73815214|NCT04767529|147179696|SUPERIORITY||percent difference|22.5||||0.036|TWO_SIDED|95.0|1.6|43.3||Threshold for significance was p\<0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors is used for comparison between the EFX 50 mg and placebo group|% difference from placebo (efruxifermin 50 mg - placebo)|Comparison between proportion of participants in efruxifermin 50 mg group who met the primary endpoint vs the placebo group||43.3|1.6|0.036
73815215|NCT04767529|147179697|SUPERIORITY||percent difference|21.8||||0.07|TWO_SIDED|95.0|-1.3|45.0||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo group||||45.0|-1.3|0.070
73815216|NCT04767529|147179697|SUPERIORITY||percent difference|51.9|||<|0.001|TWO_SIDED|95.0|31.2|72.7||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo group||Week 96||72.7|31.2|<0.001
73815217|NCT04767529|147179698|SUPERIORITY||percent difference|31.9||||0.002|TWO_SIDED|95.0|12.9|50.9||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparison between the efruxifermin 28 mg and placebo group||Week 24||50.9|12.9|0.002
73815218|NCT04767529|147179698|SUPERIORITY||percent difference|61.7|||<|0.001|TWO_SIDED|95.0|44.1|79.4||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 24||79.4|44.1|<0.001
73815219|NCT04767529|147179698|SUPERIORITY||percent difference|38.9||||0.002|TWO_SIDED|95.0|17.2|60.7||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between efruxifermin 28 mg and placebo groups||Week 96||60.7|17.2|0.002
73815220|NCT04767529|147179698|SUPERIORITY||percent difference|33.2||||0.006|TWO_SIDED|95.0|10.5|55.8||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo group||Week 96||55.8|10.5|0.006
73815221|NCT04767529|147179699|SUPERIORITY||percent difference|20.0||||0.053|TWO_SIDED|95.0|0.4|39.5||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo group||Week 24||39.5|0.4|0.053
73815222|NCT04767529|147179699|SUPERIORITY||percent difference|19.9||||0.069|TWO_SIDED|95.0|-1.5|41.2||Threshold for statistical significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 24||41.2|-1.5|0.069
73815223|NCT04767529|147179699|SUPERIORITY||percent difference|19.0||||0.123|TWO_SIDED|95.0|-4.8|42.8||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo groups||Week 96||42.8|-4.8|0.123
73815224|NCT04767529|147179699|SUPERIORITY||percent difference|49.0|||<|0.001|TWO_SIDED|95.0|27.7|70.2||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 96||70.2|27.7|<0.001
73815225|NCT04767529|147179700|SUPERIORITY|Week 24|Mean Difference (Net)|-6.9|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-9.09|-4.71||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM: fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariate for comparison||Percent change from baseline in hepatic fat fraction between the EFX 28 mg and placebo groups||-4.71|-9.09|<0.001
73815226|NCT04767529|147179700|SUPERIORITY|Week 24|Mean Difference (Net)|-9.2|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-11.47|-7.02||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 50 mg and placebo groups||-7.02|-11.47|<0.001
73815227|NCT04767529|147179700|SUPERIORITY|Week 96|Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.31||0.005|TWO_SIDED|95.0|-6.39|-1.18||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 28 mg and placebo groups||-1.18|-6.39|0.005
73815228|NCT04767529|147179700|SUPERIORITY|Week 96|Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|-8.38|-3.25||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 50 mg and placebo groups||-3.25|-8.38|<0.001
73815229|NCT04767529|147179701|SUPERIORITY|Week 24|Mean Difference (Net)|-51.6|STANDARD_ERROR_OF_MEAN|9.86|<|0.001|TWO_SIDED|95.0|-71.17|-32.11|||Mixed Models Analysis|||Treatment comparison of least squares (LS) mean change from baseline (EFX 28 mg - placebo) in triglycerides (mg/dL)||-32.11|-71.17|<0.001
73815230|NCT04767529|147179701|SUPERIORITY|Week 24|Mean Difference (Net)|-55.2|STANDARD_ERROR_OF_MEAN|9.83|<|0.001|TWO_SIDED|95.0|-74.63|-35.71|||Mixed Models Analysis|||Treatment comparison of least squares (LS) mean change from baseline (EFX 50 mg - placebo) in triglycerides (mg/dL)||-35.71|-74.63|<0.001
73815231|NCT04767529|147179701|SUPERIORITY|Week 96|Mean Difference (Net)|-43.0|STANDARD_ERROR_OF_MEAN|11.48|<|0.001|TWO_SIDED|95.0|-65.73|-20.27||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of least squares (LS) mean change from baseline (EFX 28 mg - placebo) in triglycerides (mg/dL)||-20.27|-65.73|<0.001
73815232|NCT04767529|147179701|SUPERIORITY|Week 96|Mean Difference (Net)|-47.8|STANDARD_ERROR_OF_MEAN|11.4|<|0.001|TWO_SIDED|95.0|-70.39|-25.24||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in triglycerides (mg/dL)||-25.24|-70.39|<0.001
73815233|NCT04767529|147179701|SUPERIORITY|Week 24|Mean Difference (Net)|11.0|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|7.92|14.17|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in HDL cholesterol (mg/dL)||14.17|7.92|<0.001
73815234|NCT04767529|147179701|SUPERIORITY|Week 24|Mean Difference (Net)|12.5|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|9.35|15.57|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in HDL cholesterol (mg/dL)||15.57|9.35|<0.001
73815235|NCT04767529|147179701|SUPERIORITY|Week 96|Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|2.12||0.005|TWO_SIDED|95.0|1.84|10.23||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in HDL cholesterol (mg/dL)||10.23|1.84|0.005
73815236|NCT04767529|147179701|SUPERIORITY|Week 96|Mean Difference (Net)|9.5|STANDARD_ERROR_OF_MEAN|2.11|<|0.001|TWO_SIDED|95.0|5.3|13.65||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in HDL cholesterol (mg/dL)||13.65|5.30|<0.001
73815237|NCT04767529|147179701|SUPERIORITY|Week 24|Mean Difference (Net)|-14.4|STANDARD_ERROR_OF_MEAN|4.99||0.005|TWO_SIDED|95.0|-24.28|-4.53|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 28 mg - placebo) in LDL cholesterol (mg/dL)||-4.53|-24.28|0.005
73815238|NCT04767529|147179701|SUPERIORITY|Week 24|Median Difference (Net)|-13.6|STANDARD_ERROR_OF_MEAN|4.98||0.007|TWO_SIDED|95.0|-23.5|-3.76|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in LDL cholesterol (mg/dL)||-3.76|-23.50|0.007
73815239|NCT04767529|147179701|SUPERIORITY|Week 96|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|7.04||0.99|TWO_SIDED|95.0|-13.86|14.04||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of change from baseline (EFX 28 mg - placebo) in LDL cholesterol (mg/dL)||14.04|-13.86|0.990
73815240|NCT04767529|147179701|SUPERIORITY|Week 96|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|7.01||0.98|TWO_SIDED|95.0|-14.07|13.71||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in LDL cholesterol (mg/dL)||13.71|-14.07|0.980
73815241|NCT04767529|147179701|SUPERIORITY|Week 24|Mean Difference (Net)|-22.6|STANDARD_ERROR_OF_MEAN|5.52|<|0.001|TWO_SIDED|95.0|-33.58|-11.71|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in non-HDL cholesterol (mg/dL)||-11.71|-33.58|<0.001
73815242|NCT04767529|147179701|SUPERIORITY|Week 24|Mean Difference (Net)|-22.7|STANDARD_ERROR_OF_MEAN|5.51|<|0.001|TWO_SIDED|95.0|-33.56|-11.74|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50mg - placebo) in non-HDL cholesterol (mg/dL)||-11.74|-33.56|<0.001
73815243|NCT04767529|147179701|SUPERIORITY|Week 96|Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|7.9||0.443|TWO_SIDED|95.0|-21.72|9.56||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in non-HDL cholesterol (mg/dL)||9.56|-21.72|0.443
73815244|NCT04767529|147179701|SUPERIORITY|Week 96|Mean Difference (Net)|-8.2|STANDARD_ERROR_OF_MEAN|7.86||0.299|TWO_SIDED|95.0|-23.77|7.36||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in non-HDL cholesterol (mg/dL)||7.36|-23.77|0.299
73815245|NCT04767529|147179710|SUPERIORITY|Week 24|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.18||0.75|TWO_SIDED|95.0|-1.96|2.72||Threshold for significance set at p\<0.05|Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in body weight (kg)||2.72|-1.96|0.750
73815246|NCT04767529|147179710|SUPERIORITY|Week 24|Mean Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|1.18||0.042|TWO_SIDED|95.0|-4.75|-0.09||Threshold for significance set at p\<0.05|Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in body weight (kg)||-0.09|-4.75|0.042
73815247|NCT04767529|147179710|SUPERIORITY|Week 96|Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|2.07||0.564|TWO_SIDED|95.0|-2.9|5.29|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (28 mg EFX - placebo) in body weight (kg)||5.29|-2.90|0.564
73815248|NCT04767529|147179710|SUPERIORITY|Week 96|Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|2.06||0.348|TWO_SIDED|95.0|-6.02|2.14|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in body weight (kg)||2.14|-6.02|0.348
73815249|NCT04767529|147179711|SUPERIORITY|Week 24|Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.24||0.102|TWO_SIDED|95.0|-4.5|0.4|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 28 mg - placebo) in Liver Stiffness Measurement (kPa)||0.4|-4.5|0.102
73815250|NCT04767529|147179711|SUPERIORITY|Week 24|Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|1.26||0.009|TWO_SIDED|95.0|-5.8|-0.8|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 50 mg - placebo) in Liver Stiffness Measurement (kPa)||-0.8|-5.8|0.009
73815251|NCT04767529|147179711|SUPERIORITY|Week 96|Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|1.43||0.021|TWO_SIDED|95.0|-6.2|-0.5||Threshold for significance set at P\<0.05|Mixed Models Analysis||LS Means, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX 28 mg and placebo group|Treatment comparison of change from baseline (EFX 28 mg - placebo) in Liver Stiffness Measurement (kPa)||-0.5|-6.2|0.021
73815252|NCT04767529|147179711|SUPERIORITY|Week 96|Mean Difference (Net)|-6.6|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-9.4|-3.7|||Mixed Models Analysis||LS Means, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX 50 mg and placebo group|Treatment comparison of change from baseline (EFX 50 mg - placebo) in Liver Stiffness Measurement (kPa)||-3.7|-9.4|<0.001
73815253|NCT01716520|147179712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.001|TWO_SIDED|95.0|0.085|0.157||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 milliliters (mL) at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.157|0.085|<0.001
73815254|NCT01716520|147179712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|||<|0.001|TWO_SIDED|95.0|0.1|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.171|0.100|<0.001
73815255|NCT01716520|147179712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.11|0.174||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.174|0.110|<0.001
73815256|NCT01716520|147179712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|||<|0.001|TWO_SIDED|95.0|0.067|0.13||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.130|0.067|<0.001
73815257|NCT01716520|147179712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052||||0.047|TWO_SIDED|95.0|0.001|0.104||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.104|0.001|0.047
73815258|NCT01716520|147179712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.006|TWO_SIDED|95.0|0.021|0.124||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.124|0.021|0.006
73815259|NCT01937884|147179725|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
73815260|NCT01937884|147179726|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
73815261|NCT01937884|147179727|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|Student's t-test on log-transformed change in IFABP.||||||0.27
73815262|NCT01937884|147179728|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|Student's t-test on log-transformed citrulline concentration on study day 5, by treatment group||||||0.04
73815263|NCT01937884|147179729|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|Student's t-test on log-transformed percent change of claudin 3||||||0.43
73815264|NCT01937884|147179730|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
73815265|NCT01937884|147179731|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.43
73815266|NCT01937884|147179732|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
73815267|NCT03706469|147179739|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90 percent (%) confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of Geometric Mean Ratio (GMR)|83.6|||||TWO_SIDED|90.0|74.5|93.8||||||||93.80|74.50|
73815268|NCT03706469|147179739|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|102.22|||||TWO_SIDED|90.0|91.1|114.7||||||||114.70|91.10|
73815269|NCT03706469|147179739|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.73|||||TWO_SIDED|90.0|152.55|195.58||||||||195.58|152.55|
73815270|NCT03706469|147179740|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|84.29|||||TWO_SIDED|90.0|73.92|96.11||||||||96.11|73.92|
73815271|NCT03706469|147179740|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.61|||||TWO_SIDED|90.0|88.88|111.63||||||||111.63|88.88|
73815272|NCT03706469|147179740|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.7|||||TWO_SIDED|90.0|149.07|200.09||||||||200.09|149.07|
73815273|NCT03706469|147179741|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|79.14|||||TWO_SIDED|90.0|67.36|92.99||||||||92.99|67.36|
73815274|NCT03706469|147179741|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.8|||||TWO_SIDED|90.0|84.94|117.27||||||||117.27|84.94|
73815275|NCT03706469|147179741|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|173.3|||||TWO_SIDED|90.0|150.05|200.16||||||||200.16|150.05|
73815276|NCT02635009|147179743|SUPERIORITY|||||||0.28|||||||Fisher Exact|one-sided significance level = 0.05||Proportion of participants with deterioration in HVLT-R delayed recall score at six months: Null hypothesis = No difference between the arms; Alternative hypothesis = Arm 2 will have less deterioration than Arm 1. Ninety-eight evaluable participants per arm at six months provides 80% statistical power to detect a 14.5% absolute difference between the arms in proportion of participants with deterioration at six months using a one-sided Fisher's exact test.||||0.28
73815277|NCT02635009|147179744|NON_INFERIORITY|Null hypothesis: Proportion of participants with relapse on Arm 2 - Arm 1 \> 20%; Alternative hypothesis: Proportion of participants with relapse on Arm 2 - Arm 1 = 4.5%. Using a non-inferiority margin of 20% and an assumed difference in proportions of 4.5% under the alternative, a 2-sample test of difference in proportions with a 1-sided alpha of 0.1 requires 164 patients to achieve 85% statistical power. (Statistically significant p-value indicates non-inferiority.)||||||0.003|||||||Test of binomial proportions|||||||0.0030
73815278|NCT02635009|147179745|SUPERIORITY|||||||0.0598|||||||Gray's test|||||||0.0598
73815279|NCT02635009|147179746|SUPERIORITY|||||||0.78|||||||Chi-squared|||3 months||||0.78
73815280|NCT02635009|147179746|SUPERIORITY|||||||0.63|||||||Chi-squared|||6 months||||0.63
73815281|NCT02635009|147179746|SUPERIORITY|||||||0.84|||||||Chi-squared|||12 months||||0.84
73815282|NCT02635009|147179748|SUPERIORITY|||||||0.56|||||||Chi-squared|||3 months||||0.56
73815283|NCT02635009|147179748|SUPERIORITY|||||||0.75|||||||Chi-squared|||12 months||||0.75
73815284|NCT02635009|147179750|SUPERIORITY|||||||0.81|||||||Chi-squared|||3 months||||0.81
73815285|NCT02635009|147179750|SUPERIORITY|||||||0.93|||||||Chi-squared|||6 months||||0.93
73815286|NCT02635009|147179750|SUPERIORITY|||||||0.35|||||||Chi-squared|||12 months||||0.35
73815287|NCT02635009|147179752|SUPERIORITY|||||||0.54|||||||Chi-squared|||3 months||||0.54
73815288|NCT02635009|147179752|SUPERIORITY|||||||0.43|||||||Chi-squared|||6 months||||0.43
73815289|NCT02635009|147179752|SUPERIORITY|||||||0.25|||||||Chi-squared|||12 months||||0.25
73815290|NCT02635009|147179754|SUPERIORITY|||||||0.71|||||||Chi-squared|||3 months||||0.71
73815291|NCT02635009|147179754|SUPERIORITY|||||||0.079|||||||Chi-squared|||6 months||||0.079
73815292|NCT02635009|147179754|SUPERIORITY|||||||0.85|||||||Chi-squared|||12 months||||0.85
73815293|NCT02635009|147179756|SUPERIORITY|||||||0.043|||||||Chi-squared|||3 months||||0.043
73815294|NCT02635009|147179756|SUPERIORITY|||||||0.017|||||||Fisher Exact|||6 months||||0.017
73815295|NCT02635009|147179756|SUPERIORITY|||||||0.057|||||||Chi-squared|||12-month||||0.057
73815296|NCT02635009|147179759|SUPERIORITY|||||||0.1|||||||Chi-squared|||3 months||||0.10
73815297|NCT02635009|147179759|SUPERIORITY|||||||0.33|||||||Chi-squared|||6 months||||0.33
73815298|NCT02635009|147179759|SUPERIORITY|||||||0.29|||||||Chi-squared|||12 months||||0.29
73815299|NCT02635009|147179761|SUPERIORITY|||||||0.0021|||||||Chi-squared|||3 months||||0.0021
73815300|NCT02635009|147179761|SUPERIORITY|||||||0.007|||||||Chi-squared|||6 months||||0.0070
73815301|NCT02635009|147179761|SUPERIORITY|||||||0.35|||||||Chi-squared|||12 months||||0.35
73815302|NCT02635009|147179763|SUPERIORITY|||||||0.55|||||||Chi-squared|||3 months||||0.55
73815303|NCT02635009|147179763|SUPERIORITY|||||||0.062|||||||Chi-squared|||6 months||||0.062
73815304|NCT02635009|147179763|SUPERIORITY|||||||0.32|||||||Chi-squared|||12 months||||0.32
73815305|NCT02635009|147179765|SUPERIORITY|||||||0.7|||||||Chi-squared|||3 months||||0.70
73815306|NCT02635009|147179765|SUPERIORITY|||||||0.52|||||||Chi-squared|||6 months||||0.52
73815307|NCT02635009|147179765|SUPERIORITY|||||||0.73|||||||Chi-squared|||12 months||||0.73
73815308|NCT02635009|147179767|SUPERIORITY|||||||0.28|||||||Chi-squared|||3 months||||0.28
73815309|NCT02635009|147179767|SUPERIORITY|||||||0.094|||||||Chi-squared|||6 months||||0.094
73815310|NCT02635009|147179767|SUPERIORITY|||||||0.61|||||||Chi-squared|||||||0.61
73815311|NCT02635009|147179769|SUPERIORITY|||||||0.16|||||||Chi-squared|||3 months.||||0.16
73815312|NCT02635009|147179769|SUPERIORITY|||||||0.017|||||||Chi-squared|||6 months. Assuming 50% of patients experience deterioration at 6 months, based on a prior study (RTOG-0212), a sample size of 198 participants per arm provides 94% power to detect a 50% relative reduction (50% on Arm 1 vs. 25% on Arm 2) in decline at 6 months using Fisher's exact test with a two-sided alpha=0.05.||||0.017
73815313|NCT02635009|147179769|SUPERIORITY|||||||0.56|||||||Chi-squared|||12-month||||0.56
73815314|NCT02635009|147179771|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.44
73815315|NCT02635009|147179771|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
73815316|NCT02635009|147179771|SUPERIORITY|||||||0.25|||||||Chi-squared|||||||0.25
73815317|NCT02635009|147179773|SUPERIORITY|||||||0.35|||||||Chi-squared|||3 months||||0.35
73815318|NCT02635009|147179773|SUPERIORITY|||||||0.99|||||||Chi-squared|||6 months||||0.99
73815319|NCT02635009|147179773|SUPERIORITY|||||||0.94|||||||Chi-squared|||12 months||||0.94
73815320|NCT02635009|147179777|SUPERIORITY|||||||0.79||||||Two-side significance level = 0.05|Log Rank|||||||0.79
73815321|NCT02635009|147179778|SUPERIORITY|||||||0.93|||||||Gray's test|||||||0.93
73815322|NCT02636699|147179780|OTHER||Difference in Response Rates (%)|21.7|||<|0.001|TWO_SIDED|95.0|12.4|29.8|||Wald|||Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates ≥15%.||29.8|12.4|<0.001
73815323|NCT02636699|147179781|OTHER||Difference in Response Rates (%)|19.0||||0.105|TWO_SIDED|95.0|-6.4|38.4|||Wald|||"Screening ED subgroup 1:~Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates \>0."||38.4|-6.4|0.105
73815324|NCT02636699|147179781|OTHER||Difference in Response Rates (%)|22.3|||<|0.001|TWO_SIDED|95.0|12.1|30.8|||Wald|||"Screening ED subgroup 2:~Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates \>0."||30.8|12.1|<0.001
73815325|NCT02636699|147179782|OTHER||Difference in Median CRD|297.0|||<|0.001|TWO_SIDED|95.0|130.0|317.0|||Wilcoxon rank-sum test|||The treatment effect was estimated using the Hodges-Lehmann estimate of the difference in median CRDs at Month 12.||317.0|130.0|<0.001
73815326|NCT00981058|147179789|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.842||||0.012|TWO_SIDED|95.0|0.736|0.962|||Log Rank|||||0.962|0.736|0.0120
73815327|NCT00981058|147179790|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.851||||0.0201|TWO_SIDED|95.0|0.743|0.975|||Log Rank|||||0.975|0.743|0.0201
73815328|NCT00981058|147179791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.3997|TWO_SIDED|95.0|0.86|1.45|||Cochran-Mantel-Haenszel|||||1.45|0.86|0.3997
73815329|NCT00981058|147179792|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.0061|TWO_SIDED|95.0|0.747|0.953|||Log Rank|||||0.953|0.747|0.0061
73815330|NCT02667587|147179798|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||||1.25|0.90|
73815331|NCT02667587|147179799|SUPERIORITY||Cox Proportional Hazard|1.12||||0.3402|TWO_SIDED|96.39|0.87|1.43|||Log Rank|||All Randomized No Baseline Corticosteroids Participants||1.43|0.87|0.3402
73815332|NCT02667587|147179799|SUPERIORITY||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|0.91|1.33||||||All Randomized Participants||1.33|0.91|
73815333|NCT02667587|147179803|SUPERIORITY||Cox Proportional Hazard|1.18|||||TWO_SIDED|95.0|0.99|1.4||||||||1.40|0.99|
73815334|NCT02667587|147179804|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.89|1.26|||Log Rank|||||1.26|0.89|
73815335|NCT01973335|147179805|SUPERIORITY||Mean Difference (Final Values)|30.0||||0.515|TWO_SIDED|95.0|-63.0|123.0||Not adjusted for multiple comparisons|t-test, 2 sided|||2x2 factorial design: both acetazolamide groups together are compared with both high-dose loop diuretic groups together||123|-63|0.515
73815336|NCT01973335|147179806|SUPERIORITY||Risk Difference (RD)|-0.2||||0.27|TWO_SIDED|||||Not adjusted for multiple comparisons|Fisher Exact|||2x2 factorial design: analysis according to spironolactone use||||0.270
73815337|NCT01636947|147179831|SUPERIORITY_OR_OTHER|||||||0.191|||||||Pearson's chi-square test|||||||0.191
73815338|NCT01636947|147179832|SUPERIORITY_OR_OTHER|||||||0.458|||||||Pearson's chi-square test|||Overall Stage p-value||||0.458
73815339|NCT02603107|147179912|NON_INFERIORITY|A sample size of 520 participants (260 participants per treatment group) would provide at least 90% power to establish a non-inferiority margin of 4% in the Week 48 response rate (HIV-1 RNA ≥ 50 copies/mL) between the 2 treatment groups. Sample size was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in Percentages|0.0|||||TWO_SIDED|95.002|-2.5|2.5|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.||2.5|-2.5|
73815340|NCT02603107|147179912|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73815341|NCT02603107|147179913|NON_INFERIORITY|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.002% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|3.2|||||TWO_SIDED|95.002|-1.6|8.2|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||8.2|-1.6|
73815342|NCT02603107|147179913|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
73815343|NCT02603107|147179914|SUPERIORITY||Difference in Least Squares Means (LSM)|25.0||||0.068|TWO_SIDED|95.0|-2.0|52.0|||ANOVA|||||52|-2|0.068
73815344|NCT03411902|147179923|SUPERIORITY|||||||0.048|||||||Mixed Models Analysis|||||||0.048
73815345|NCT03411902|147179924|SUPERIORITY|||||||0.745|||||||Mixed Models Analysis|||||||0.745
73815346|NCT03411902|147179925|SUPERIORITY|||||||0.163|||||||Mixed Models Analysis|||||||0.163
73815347|NCT03411902|147179926|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
73815348|NCT03411902|147179927|SUPERIORITY|||||||0.337|||||||Mixed Models Analysis|||Pertaining to Radius 33 BMD||||0.337
73815349|NCT03411902|147179927|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||Pertaining to Radius UD BMD||||0.238
73815350|NCT03411902|147179928|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.860
73815351|NCT00419159|147179934|OTHER||Odds Ratio (OR)|1.8||||0.253|TWO_SIDED|95.0|0.657|4.929|||Unadjusted Logistic Regression|||||4.929|0.657|0.253
73815352|NCT00419159|147179935|OTHER||Odds Ratio (OR)|0.382||||0.07|TWO_SIDED|95.0|0.135|1.083|||Unadjusted Logistic Regression|||||1.083|0.135|0.070
73815353|NCT00419159|147179936|OTHER||Hazard Ratio (HR)|0.814||||0.399|TWO_SIDED|95.0|0.505|1.312|||Unadjusted Logistic Regression|||||1.312|0.505|0.399
73815354|NCT00419159|147179936|OTHER||Hazard Ratio, log|1.001||||0.995|TWO_SIDED|95.0|0.62|1.617|||Unadjusted Logistic Regression|||||1.617|0.620|0.995
73815355|NCT00419159|147179937|OTHER||Hazard Ratio, log|1.203||||0.441|TWO_SIDED|95.0|0.752|1.923|||Unadjusted Logistic Regression|||||1.923|0.752|0.441
73815356|NCT00419159|147179937|OTHER||Hazard Ratio, log|1.547||||0.126|TWO_SIDED|95.0|0.884|2.708|||Unadjusted Logistic Regression|||||2.708|0.884|0.126
73815357|NCT00419159|147179938|OTHER||Odds Ratio (OR)|0.529||||0.238|TWO_SIDED|95.0|0.184|1.523|||Unadjusted Logistic Regression|||||1.523|0.184|0.238
73815358|NCT00419159|147179939|OTHER||Odds Ratio (OR)|1.044||||0.938|TWO_SIDED|95.0|0.352|3.099|||Unadjusted Logistic Regression|||||3.099|0.352|0.938
73815359|NCT00419159|147179940|OTHER||Hazard Ratio (HR)|1.474||||0.145|TWO_SIDED|95.0|0.875|2.484|||Unadjusted Cox Model|||||2.484|0.875|0.145
73815360|NCT00419159|147179940|OTHER||Hazard Ratio, log|1.151||||0.583|TWO_SIDED|95.0|0.696|1.903|||Unadjusted Cox Model|||||1.903|0.696|0.583
73815361|NCT00419159|147179941|OTHER||Hazard Ratio (HR)|0.868||||0.588|TWO_SIDED|95.0|0.521|1.447|||Unadjusted Cox Model|||||1.447|0.521|0.588
73815362|NCT00419159|147179941|OTHER||Hazard Ratio (HR)|0.611||||0.148|TWO_SIDED|95.0|0.314|1.191|||Unadjusted Cox Model|||||1.191|0.314|0.148
73815363|NCT01017601|147179947|OTHER|||||||0.5|||||||Wilcoxon Rank Sum|||||||0.50
73815364|NCT01017601|147179948|OTHER|||||||0.96|||||||Wilcoxon Rank Sum|||||||0.96
73815365|NCT01017601|147179949|OTHER|||||||0.54|||||||Fisher Exact|||||||0.54
73815366|NCT01017601|147179950|OTHER|||||||1|||||||Fisher Exact|||||||1.0
73815367|NCT02638259|147179958|EQUIVALENCE|A margin of 0.6 can be statistically and clinically justified based on the results Keystone et al, Arthritis and Rheumatism, p353-363, (2004) and on the EULAR response criteria. The sample size of 155 per group with 90% power is based on the common SD of 1.46 and was calculated using nQuery 7.0.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.097|||TWO_SIDED|95.0|-0.26|0.12||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 24 will be concluded if the 95% confidence interval for the LS mean difference between GP2015 and Enbrel is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.12|-0.26|
73815368|NCT02952872|147180009|SUPERIORITY||||||<|0.05|||||||ANOVA|Mixed Design ANOVA||||||<.05
73815369|NCT02952872|147180010|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
73815370|NCT02952872|147180011|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
73815371|NCT02952872|147180012|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
73815372|NCT02638051|147180025|SUPERIORITY_OR_OTHER|||||||0.014|||||||Chi-squared|||"Applies to Objective Response Rate (ORR)"||||0.0140
73815373|NCT02638051|147180026|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Chi-squared|||"Applies to All Adverse Events rate"||||0.0016
73815374|NCT02638051|147180026|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Abdominal pain rate"||||>0.05
73815375|NCT02638051|147180026|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Gastrointestinal reactions"||||>0.05
73815376|NCT02638051|147180026|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Damage of hepatic or renal function"||||>0.05
73815377|NCT02638051|147180026|SUPERIORITY_OR_OTHER|||||||0.0215|||||||Chi-squared|||"Applies to Bone marrow depression"||||0.0215
73815378|NCT02638051|147180027|SUPERIORITY_OR_OTHER|||||||0.0053|||||||Chi-squared|||"Applies to Better QoL"||||0.0053
73815379|NCT02638051|147180027|SUPERIORITY_OR_OTHER|||||||0.0527|||||||Chi-squared|||"Applies to No Change"||||0.0527
73815380|NCT02638051|147180027|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Worse QoL"||||>0.05
73815381|NCT01969084|147180082|SUPERIORITY_OR_OTHER||||||>|0.05||||||A p-value of \< 0.05 was considered statistically significant|Wilcoxon (Mann-Whitney)|||Data were expressed as the median (25th:75th percentiles) for non-normally distributed data. The mean±sd for the groups was not analyzed as per the statistical plan.||||>0.05
73815382|NCT00862459|147180095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_DEVIATION|1.49||0.003|||||||t-test, 2 sided|||2 sample t-test between the dose groups||||0.003
73815383|NCT00862459|147180095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|1.59||0.844|||||||t-test, 2 sided|||||||0.844
73815384|NCT00862459|147180096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|STANDARD_DEVIATION|2.92||||95.0|-0.825|0.69|||confidence interval using t-distribution|||||0.69|-0.825|
73815385|NCT00862459|147180096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|3.18||||95.0|-0.9|0.79|||confidence interval using t-distribution|||||0.79|-0.90|
73815386|NCT00862459|147180097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|1.42||||95.0|-1.17|-0.42|||confidence interval using t-distribution|||||-0.42|-1.17|
73815387|NCT00862459|147180097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|1.57||||95.0|-0.44|0.41|||confidence interval using t-distribution|||||0.41|-0.44|
73815388|NCT00862459|147180098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|0.86||||95.0|-0.619|-0.17|||confidence interval using t-distribution|||||-0.17|-0.619|
73815389|NCT00862459|147180098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|1.01||||95.0|-0.25|0.22|||confidence interval using t-distribution|||||0.22|-0.25|
73815390|NCT00862459|147180099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_DEVIATION|0.76||||95.0|-0.58|-0.18|||confidence interval using t-distribution|||||-0.18|-0.58|
73815391|NCT00862459|147180099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.76||||95.0|-0.1|0.31|||confidence interval using t-distribution|||||0.31|-0.10|
73815392|NCT00862459|147180100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.54|STANDARD_DEVIATION|76.45||||95.0|-37.11|2.02|||confidence interval using t-distribution|||difference in CNR between doses and confidence interval||2.02|-37.11|
73815393|NCT00862459|147180100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.74|STANDARD_DEVIATION|77.11||||95.0|-15.86|25.35|||confidence interval using t-distribution|||||25.35|-15.86|
73815394|NCT00862459|147180101|SUPERIORITY_OR_OTHER||accuracy difference|1.66|STANDARD_ERROR_OF_MEAN|6.29||0.8||95.0|-10.93|14.24|||Chi-squared|Adjusted for clustering||||14.24|-10.93|0.80
73815395|NCT00862459|147180101|SUPERIORITY_OR_OTHER||difference in accuracies|-10.75|STANDARD_ERROR_OF_MEAN|6.83||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering||||2.90|-24.41|0.13
73815396|NCT00862459|147180102|SUPERIORITY_OR_OTHER||difference in accuracy|13.43||||0.03||95.0|1.53|25.33|||Chi-squared|adjusted for clustering||||25.33|1.53|0.03
73815397|NCT00862459|147180102|SUPERIORITY_OR_OTHER||difference in accuracies|-13.58||||0.02||95.0|-25.07|-2.09|||Chi-squared|adjusted for clustering||||-2.09|-25.07|0.02
73815398|NCT00862459|147180103|SUPERIORITY_OR_OTHER||difference in accuracy|-6.13||||0.11||95.0|-13.73|1.48|||Chi-squared|adjusted for clustering||||1.48|-13.73|0.11
73815399|NCT00862459|147180103|SUPERIORITY_OR_OTHER||difference in accuracies|2.87||||0.55||95.0|-6.59|12.32|||Chi-squared|adjusted for clustering||||12.32|-6.59|0.55
73815400|NCT00862459|147180104|SUPERIORITY_OR_OTHER||difference in accuracy|24.63||||0.02||95.0|5.39|43.86|||Chi-squared|adjusted for clustering||||43.86|5.39|0.02
73815401|NCT00862459|147180104|SUPERIORITY_OR_OTHER||difference in accuracy|-10.75||||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering||||2.90|-24.41|0.13
73815402|NCT00862459|147180105|SUPERIORITY_OR_OTHER||difference in accuracy|12.91||||0.07||95.0|-1.44|27.26|||Chi-squared|adjusted for clustering||||27.26|-1.44|0.07
73815403|NCT00862459|147180105|SUPERIORITY_OR_OTHER||difference in accuracy|-18.37||||0.02||95.0|-33.6|-1.35|||Chi-squared|adjusted for clustering||||-1.35|-33.60|0.02
73815404|NCT00862459|147180106|SUPERIORITY_OR_OTHER||difference in accuracy|18.46||||0.02||95.0|3.15|33.77|||Chi-squared|adjusted for clustering||||33.77|3.15|0.02
73815405|NCT00862459|147180106|SUPERIORITY_OR_OTHER||difference in accuracy|-5.29||||0.45||95.0|-18.83|8.24|||Chi-squared|adjusted for clustering||||8.24|-18.83|0.45
73815406|NCT04015518|147180149|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-10.5|STANDARD_ERROR_OF_MEAN|8.5||0.2179|TWO_SIDED|95.0|-27.4|6.3|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||6.3|-27.4|0.2179
73815407|NCT04015518|147180149|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-14.6|STANDARD_ERROR_OF_MEAN|8.5||0.0883|TWO_SIDED|95.0|-31.5|2.2|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||2.2|-31.5|0.0883
73815408|NCT04015518|147180149|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-12.6|STANDARD_ERROR_OF_MEAN|8.5||0.1414|TWO_SIDED|95.0|-29.4|4.3|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||4.3|-29.4|0.1414
73896489|NCT00913458|147326241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.18||||0.0166|TWO_SIDED|95.0|1.6|94.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||94.2|1.6|0.0166
73815409|NCT04015518|147180149|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.3|STANDARD_ERROR_OF_MEAN|7.0||0.4514|TWO_SIDED|95.0|-19.1|8.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||8.6|-19.1|0.4514
73815410|NCT04015518|147180149|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.212||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2120
73815411|NCT04015518|147180149|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1057||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1057
73815412|NCT04015518|147180149|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.5241||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.5241
73815413|NCT04015518|147180149|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2773||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2773
73815414|NCT04015518|147180149|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.3867||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.3867
73815415|NCT04015518|147180150|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-6.1|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-19.3|7.1|||||Difference was calculated as Speso - placebo.|||7.1|-19.3|
73815416|NCT04015518|147180150|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.4|STANDARD_ERROR_OF_MEAN|6.8|||TWO_SIDED|95.0|-18.8|8.0|||||Difference was calculated as Speso - placebo.|||8.0|-18.8|
73815417|NCT04015518|147180150|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-3.5|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-16.6|9.7|||||Difference was calculated as Speso - placebo.|||9.7|-16.6|
73815418|NCT04015518|147180150|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-9.4|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-20.3|1.4|||||Difference was calculated as Speso - placebo.|||1.4|-20.3|
73815419|NCT04015518|147180151|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-4.1|STANDARD_ERROR_OF_MEAN|6.9||0.5595|TWO_SIDED|95.0|-17.7|9.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||9.6|-17.7|0.5595
73815420|NCT04015518|147180151|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|0.9|STANDARD_ERROR_OF_MEAN|6.9||0.8968|TWO_SIDED|95.0|-12.7|14.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||14.5|-12.7|0.8968
73815421|NCT04015518|147180151|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-4.2|STANDARD_ERROR_OF_MEAN|6.9||0.5456|TWO_SIDED|95.0|-17.9|9.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||9.5|-17.9|0.5456
73815422|NCT04015518|147180151|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-7.7|STANDARD_ERROR_OF_MEAN|5.7||0.1762|TWO_SIDED|95.0|-19.0|3.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||3.5|-19.0|0.1762
73815423|NCT04015518|147180151|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1726||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1726
73815424|NCT04015518|147180151|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2353||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2353
73815425|NCT04015518|147180151|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1346||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1346
73815426|NCT04015518|147180151|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.195||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1950
73815427|NCT04015518|147180151|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1681||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1681
73815428|NCT04015518|147180152|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2812|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.5|-1.8|0.2812
73815429|NCT04015518|147180152|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.3357|TWO_SIDED|95.0|-1.7|0.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.6|-1.7|0.3357
73815430|NCT04015518|147180152|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.8|STANDARD_ERROR_OF_MEAN|0.6||0.1809|TWO_SIDED|95.0|-2.0|0.4|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.4|-2.0|0.1809
73815431|NCT04015518|147180152|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8322|TWO_SIDED|95.0|-1.1|0.9|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.9|-1.1|0.8322
73815432|NCT04015518|147180152|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.4035||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.4035
73815433|NCT04015518|147180152|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2563||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2563
73815434|NCT04015518|147180152|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.681||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.6810
73815435|NCT04015518|147180152|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.4665||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.4665
73815436|NCT04015518|147180152|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.5565||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.5565
73815437|NCT04015518|147180153|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.042|||||TWO_SIDED|95.0|-0.17|0.281|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.281|-0.170|
73815438|NCT04015518|147180153|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.195|||||TWO_SIDED|95.0|-0.048|0.432|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.432|-0.048|
73815439|NCT04015518|147180153|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.27|||||TWO_SIDED|95.0|0.02|0.496|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.496|0.020|
73815440|NCT04015518|147180153|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.129|||||TWO_SIDED|95.0|-0.067|0.314|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.314|-0.067|
73815441|NCT04015518|147180153|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0613||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0613
73815442|NCT04015518|147180153|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0628||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0628
73815443|NCT04015518|147180153|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.1449||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1449
73815444|NCT04015518|147180153|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.046||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0460
73896490|NCT00913458|147326241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.3619|TWO_SIDED|95.0|0.6|4.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.5|0.6|0.3619
73896491|NCT00913458|147326242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23||||0.0017|TWO_SIDED|95.0|1.6|6.7|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||6.7|1.6|0.0017
73815445|NCT04015518|147180153|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0677||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0677
73815446|NCT04015518|147180154|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.063|||||TWO_SIDED|95.0|-0.069|0.256|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.256|-0.069|
73815447|NCT04015518|147180154|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.188|||||TWO_SIDED|95.0|0.018|0.405|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.405|0.018|
73815448|NCT04015518|147180154|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.102|||||TWO_SIDED|95.0|-0.042|0.303|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.303|-0.042|
73815449|NCT04015518|147180154|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.113|||||TWO_SIDED|95.0|-0.018|0.25|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.250|-0.018|
73815450|NCT04015518|147180154|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0536||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0536
73815451|NCT04015518|147180154|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0476||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0476
73815452|NCT04015518|147180154|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.1076||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1076
73896492|NCT00913458|147326242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.05|||<|0.0001|TWO_SIDED|95.0|4.4|28.0|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||28.0|4.4|<0.0001
73896493|NCT00913458|147326242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42||||0.0111|TWO_SIDED|95.0|1.3|8.8|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||8.8|1.3|0.0111
73815453|NCT04015518|147180154|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0606||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0606
73815454|NCT04015518|147180154|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0824||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0824
73815455|NCT04015518|147180155|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.211|||||TWO_SIDED|95.0|0.04|0.422|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.422|0.040|
73815456|NCT04015518|147180155|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.018|0.339|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.339|-0.018|
73815457|NCT04015518|147180155|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.125|||||TWO_SIDED|95.0|-0.022|0.328|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.328|-0.022|
73815458|NCT04015518|147180155|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.144|||||TWO_SIDED|95.0|0.009|0.282|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.282|0.009|
73815459|NCT04015518|147180155|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0333||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0333
73815460|NCT04015518|147180155|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0221||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regime"||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0221
73896494|NCT00913458|147326243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.66||||0.0328|TWO_SIDED|95.0|-16.6|-0.7|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.7|-16.6|0.0328
73896495|NCT00913458|147326243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.64|||<|0.0001|TWO_SIDED|95.0|-30.1|-13.2|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-13.2|-30.1|<0.0001
73815461|NCT04015518|147180155|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0707||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0707
73815462|NCT04015518|147180155|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0578||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0578
73815463|NCT04015518|147180155|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0771||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0771
73815464|NCT04015518|147180156|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.202|||||TWO_SIDED|95.0|-0.005|0.427|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.427|-0.005|
73815465|NCT04015518|147180156|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.17|||||TWO_SIDED|95.0|-0.032|0.401|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.401|-0.032|
73815466|NCT04015518|147180156|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.248|||||TWO_SIDED|95.0|0.032|0.471|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.471|0.032|
73815467|NCT04015518|147180156|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.202|||||TWO_SIDED|95.0|0.024|0.367|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.367|0.024|
73815468|NCT04015518|147180156|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0158||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0158
73896496|NCT00913458|147326243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.98||||0.0035|TWO_SIDED|95.0|-21.5|-4.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-4.5|-21.5|0.0035
73896497|NCT00913458|147326244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.36||||0.2473|TWO_SIDED|95.0|-11.8|3.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||3.1|-11.8|0.2473
73815469|NCT04015518|147180156|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.012||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0120
73815470|NCT04015518|147180156|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0429||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0429
73815471|NCT04015518|147180156|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0229||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0229
73815472|NCT04015518|147180156|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.03||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0300
73815473|NCT04015518|147180157|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-18.7|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-37.2|-0.2|||||Difference was calculated as Speso - placebo.|||-0.2|-37.2|
73815474|NCT04015518|147180157|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-19.3|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|95.0|-38.3|-0.2|||||Difference was calculated as Speso - placebo.|||-0.2|-38.3|
73815475|NCT04015518|147180157|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-26.6|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-45.5|-7.8|||||Difference was calculated as Speso - placebo.|||-7.8|-45.5|
73815476|NCT04015518|147180157|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.4|STANDARD_ERROR_OF_MEAN|7.9|||TWO_SIDED|95.0|-21.1|10.2|||||Difference was calculated as Speso - placebo.|||10.2|-21.1|
73815477|NCT01738191|147180159|SUPERIORITY|||||||0.25||||||two sided|Global Statistical Test|df=28||The primary comparison between ATM and placebo used O'Brien's Global Statistical Test (GST) to analyze change from baseline to 10 weeks for the set of neuropsychological measures included in the primary efficacy outcome.||||0.25
73815478|NCT00727090|147180200|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence|||||<|0.05|||||||t-test, 2 sided|||Null Hypothesis: Change in serum sodium from baseline is not different between groups||||<0.05
73815479|NCT04591015|147180230|SUPERIORITY|||||||0.0626|||||||Fisher Exact|||||||0.0626
73815480|NCT04591015|147180231|SUPERIORITY|||||||0.0496|||||||t-test, 2 sided|||Only includes participants who completed a 90-day lab||||0.0496
73815481|NCT04591015|147180232|SUPERIORITY|||||||0.0651|||||||t-test, 2 sided|||Only includes participants who completed a 180-day lab||||0.0651
73815482|NCT04591015|147180233|SUPERIORITY|||||||0.8739|||||||Fisher Exact|||||||0.8739
73815483|NCT04591015|147180234|SUPERIORITY|||||||0.4702|||||||t-test, 2 sided|||||||0.4702
73815484|NCT04591015|147180235|SUPERIORITY|||||||0.1258|||||||t-test, 2 sided|||||||0.1258
73815485|NCT04591015|147180236|SUPERIORITY|||||||0.8635|||||||t-test, 2 sided|||||||0.8635
73815486|NCT04591015|147180237|SUPERIORITY|||||||0.0471|||||||t-test, 2 sided|||||||0.0471
73815487|NCT04591015|147180238|SUPERIORITY|||||||0.0218|||||||t-test, 2 sided|||||||0.0218
73815488|NCT04591015|147180239|SUPERIORITY|||||||0.509|||||||t-test, 2 sided|||||||0.5090
73815489|NCT04591015|147180240|SUPERIORITY|||||||0.4034|||||||t-test, 2 sided|||||||0.4034
73815490|NCT04591015|147180241|SUPERIORITY|||||||0.0175|||||||t-test, 2 sided|||||||0.0175
73815491|NCT04591015|147180242|SUPERIORITY|||||||0.4435|||||||Fisher Exact|||||||0.4435
73815492|NCT04591015|147180243|SUPERIORITY|||||||0.7417|||||||Fisher Exact|||||||0.7417
73815493|NCT04591015|147180244|SUPERIORITY|||||||0.5779|||||||t-test, 2 sided|||||||0.5779
73815494|NCT04591015|147180245|SUPERIORITY|||||||0.0493|||||||t-test, 2 sided|||||||0.0493
73815495|NCT04591015|147180246|SUPERIORITY|||||||0.0773|||||||t-test, 2 sided|||||||0.0773
73815496|NCT04591015|147180247|SUPERIORITY|||||||0.0921|||||||t-test, 2 sided|||||||0.0921
73815497|NCT04591015|147180248|SUPERIORITY|||||||0.2404|||||||t-test, 2 sided|||||||0.2404
73815498|NCT04591015|147180249|SUPERIORITY|||||||0.8955|||||||t-test, 2 sided|||||||0.8955
73815499|NCT02686814|147180265|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-0.9||||0.7646|TWO_SIDED||||||Wilcoxon signed-rank test|||3-6 Month compared to Baseline||||0.7646
73815500|NCT02686814|147180265|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|3.9||||0.8984|TWO_SIDED||||||Wilcoxon signed-rank test|||1 Year compared to Baseline||||0.8984
73815501|NCT02686814|147180265|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|0.0||||0.8457|TWO_SIDED||||||Wilcoxon signed-rank test|||2 Year compared to Baseline||||0.8457
73815502|NCT02686814|147180265|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-7.7||||0.1309|TWO_SIDED||||||Wilcoxon signed-rank test|||3 Year compared to Baseline||||0.1309
73815503|NCT02686814|147180265|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-15.2||||0.5|TWO_SIDED||||||Wilcoxon signed-rank test|||4 Year compared to Baseline||||0.5000
73815504|NCT02686814|147180266|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|1.5||||0.2783|TWO_SIDED||||||Wilcoxon signed-rank test|||3-6 Month compared to Baseline||||0.2783
73815505|NCT02686814|147180266|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|6.4||||0.0674|TWO_SIDED||||||Wilcoxon signed-rank test|||1 Year compared to Baseline||||0.0674
73815506|NCT02686814|147180266|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|6.4||||0.0371|TWO_SIDED||||||Wilcoxon signed-rank test|||2 Year compared to Baseline||||0.0371
73815507|NCT02686814|147180266|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|0.8||||0.6953|TWO_SIDED||||||Wilcoxon signed-rank test|||3 Year compared to Baseline||||0.6953
73815508|NCT02686814|147180266|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|1.0|||>|0.9999|TWO_SIDED||||||Wilcoxon signed-rank test|||4 Year compared to Baseline||||>0.9999
73815509|NCT02722746|147180359|SUPERIORITY||percent difference|20.8||||0.165|TWO_SIDED|95.0|-8.9|47.3|||Z-test for proportions|||||47.3|-8.9|0.165
73815510|NCT02722746|147180359|SUPERIORITY||percent difference|14.4||||0.353|TWO_SIDED|95.0|-15.9|42.2|||Z-test for proportions|||||42.2|-15.9|0.353
73815511|NCT02722746|147180360|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||For PACU spread||||0.06
73815512|NCT02722746|147180360|SUPERIORITY|||||||0.22|||||||Kruskal-Wallis|||For Pre-op spread||||0.22
73815513|NCT02722746|147180360|SUPERIORITY|||||||0.74|||||||Kruskal-Wallis|||For POD 1||||0.74
73815514|NCT02722746|147180361|SUPERIORITY|||||||0.551|||||||ANOVA|||||||0.551
73815515|NCT02722746|147180362|SUPERIORITY|||||||0.349|||||||Mixed Models Analysis|||||||0.349
73815516|NCT02722746|147180363|SUPERIORITY|||||||0.18|||||||Fisher Exact|||For Pruritis||||0.18
73815517|NCT02722746|147180363|SUPERIORITY|||||||0.44|||||||Fisher Exact|||For Nausea/Vomiting||||0.44
73815518|NCT02722746|147180363|SUPERIORITY|||||||0.74|||||||Fisher Exact|||For Respirartory Depression||||0.74
73815519|NCT02722746|147180367|SUPERIORITY|||||||0.524|||||||ANOVA|||For SBP||||0.524
73815520|NCT02722746|147180367|SUPERIORITY|||||||0.585|||||||ANOVA|||For DBP||||0.585
73815521|NCT02722746|147180367|SUPERIORITY|||||||0.199|||||||ANOVA|||For MAP||||0.199
73815522|NCT02722746|147180368|SUPERIORITY|||||||0.231|||||||Mixed Models Analysis|||||||0.231
73815523|NCT02722746|147180369|SUPERIORITY|||||||0.016|||||||ANOVA|||||||0.016
73815524|NCT02722746|147180370|SUPERIORITY|||||||0.055|||||||ANOVA|||||||0.055
73815525|NCT02722746|147180371|SUPERIORITY|||||||0.567|||||||ANOVA|||||||0.567
73815526|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.055|||||TWO_SIDED|95.0|-0.067|0.178||||||Dengue Virus Serotype 1: Phase III Lot 1 vs Lot 2||0.178|-0.067|
73815527|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.024|||||TWO_SIDED|95.0|-0.102|0.151||||||Dengue Virus Serotype 1: Phase III Lot 2 vs Lot 3||0.151|-0.102|
73815528|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.08|||||TWO_SIDED|95.0|-0.204|0.045||||||Dengue Virus Serotype 1: Phase III Lot 3 vs Lot 1||0.045|-0.204|
73815529|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.174|||||TWO_SIDED|95.0|0.009|0.34||||||Dengue Virus Serotype 2: Phase III Lot 1 vs Lot 2||0.340|0.009|
73815530|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.12|||||TWO_SIDED|95.0|-0.297|0.056||||||Dengue Virus Serotype 2: Phase III Lot 2 vs Lot 3||0.056|-0.297|
73815531|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.054|||||TWO_SIDED|95.0|-0.225|0.117||||||Dengue Virus Serotype 2: Phase III Lot 3 vs Lot 1||0.117|-0.225|
73815532|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.058|||||TWO_SIDED|95.0|-0.068|0.184||||||Dengue Virus Serotype 3: Phase III Lot 1 vs Lot 2||0.184|-0.068|
73815533|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.042|||||TWO_SIDED|95.0|-0.167|0.082||||||Dengue Virus Serotype 3: Phase III Lot 2 vs Lot 3||0.082|-0.167|
73815534|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.016|||||TWO_SIDED|95.0|-0.144|0.113||||||Dengue Virus Serotype 3: Phase III Lot 3 vs Lot 1||0.113|-0.144|
73815535|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.144|||||TWO_SIDED|95.0|-0.006|0.295||||||Dengue Virus Serotype 4: Phase III Lot 1 vs Lot 2||0.295|-0.006|
73815536|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.06|||||TWO_SIDED|95.0|-0.207|0.088||||||Dengue Virus Serotype 4: Phase III Lot 2 vs Lot 3||0.088|-0.207|
73815537|NCT01134263|147180372|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.085|||||TWO_SIDED|95.0|-0.242|0.073||||||Dengue Virus Serotype 4: Phase III Lot 3 vs Lot 1||0.073|-0.242|
73815538|NCT01134263|147180373|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.091|||||TWO_SIDED|95.0|-0.009|0.192||||||Dengue Virus Serotype 1||0.192|-0.009|
73815539|NCT01134263|147180373|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.334|||||TWO_SIDED|95.0|0.202|0.466||||||Dengue Virus Serotype 2||0.466|0.202|
73815540|NCT01134263|147180373|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.076|||||TWO_SIDED|95.0|-0.173|0.021||||||Dengue Virus Serotype 3||0.021|-0.173|
73815541|NCT01134263|147180373|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.017|||||TWO_SIDED|95.0|-0.137|0.103||||||Dengue Virus Serotype 4||0.103|-0.137|
73815542|NCT02867202|147180406|OTHER||||||<|0.05|||||||t-test, 2 sided|||Data analysis was performed with SPSS version 22.0, using two-sided test, and a p value \< 0.05 was considered statistically significant.||||<0.05
73815543|NCT03292471|147180408|SUPERIORITY|Dependent variable: PNT T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Pre-treatment, Post-treatment) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions (PNT raw score converted to T-score scale with m = 50, sd = 10 based on sample estimates from Fergadiotis, Hula, \& Kellough, 2015)|Highest Density Interval of Posterior Di|0.284|||||TWO_SIDED|95.0|-2.07|2.92|||||Direction of comparison: Group A (Standard Protocol) and post-treatment timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.92|-2.07|
73815544|NCT03292471|147180408|SUPERIORITY|Dependent variable: PNT T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Pre-treatment, Follow-up) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions (PNT raw score converted to T-score scale with m = 50, sd = 10 based on sample estimates from Fergadiotis, Hula, \& Kellough, 2015)|Highest Density Interval of Posterior Di|0.02|||||TWO_SIDED|95.0|-2.38|2.46|||||Direction of comparison: Group A (Standard Protocol) and follow-up (2 months post-treatment) timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.46|-2.38|
73815545|NCT03292471|147180409|SUPERIORITY|Dependent variable: CAT Mean-modality T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Entry, Exit) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions|Highest Density Interval of Posterior Di|0.997|||||TWO_SIDED|95.0|-0.0719|2.25|||||Direction of comparison: Group A (Standard Protocol) and post-treatment timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.25|-0.0719|
73815546|NCT03292471|147180409|SUPERIORITY|Dependent variable: CAT Mean-modality T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time-point (Pre-treatment, Post-treatment) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions|Highest Density Interval of Posterior Di|0.443|||||TWO_SIDED|95.0|-0.596|1.58|||||Direction of comparison: Group A (Standard Protocol) and follow-up (2 months post-treatment) timepoint were set as reference values|Baysian Multivariate Analysis of Variance||1.58|-0.596|
73815547|NCT00911586|147180410|OTHER|Part 1 of piecewise linear regression model.|Slope|-4.077|STANDARD_ERROR_OF_MEAN|16.02||0.806|TWO_SIDED||||||Regression, Linear|Part 1 of piecewise linear regression model.|Part 1 of piecewise linear regression model.|||||0.8060
73815548|NCT00911586|147180411|OTHER|Part 2 of piecewise linear regression model.|Slope|4.114|STANDARD_ERROR_OF_MEAN|18.456||0.8286|TWO_SIDED||||||Regression, Linear|Part 2 of piecewise linear regression model.|Part 2 of piecewise linear regression model.|||||0.8286
73815549|NCT03763058|147180420|SUPERIORITY||Mean Difference (Final Values)|-2.8|STANDARD_DEVIATION|4.19||0.012|TWO_SIDED|95.0|||||Sign test|||||||0.012
73815550|NCT03763058|147180421|SUPERIORITY||Mean Difference (Final Values)|-5.45|STANDARD_DEVIATION|15.52||0.002|TWO_SIDED|95.0|||||Sign test|||||||0.002
73815551|NCT03763058|147180422|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|2.71||0.045|TWO_SIDED|95.0|||||Sign test|||||||0.045
73815552|NCT03763058|147180423|SUPERIORITY||Mean Difference (Final Values)|-3.65|STANDARD_DEVIATION|4.59|<|0.001|TWO_SIDED|95.0|||||Sign test|||||||<0.001
73815553|NCT03763058|147180424|SUPERIORITY||Mean Difference (Final Values)|-4.15|STANDARD_DEVIATION|5.1|<|0.001|TWO_SIDED|95.0|||||Sign test|||Total HAD score||||<0.001
73815554|NCT02051335|147180425|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.556||0.573|TWO_SIDED|95.0|-1.4|0.8||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||0.8|-1.4|0.573
73815555|NCT02051335|147180425|SUPERIORITY_OR_OTHER||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.55||0.21|TWO_SIDED|95.0|-1.8|0.4||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||0.4|-1.8|0.210
73815556|NCT02051335|147180425|SUPERIORITY_OR_OTHER||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.547||0.821|TWO_SIDED|95.0|-1.0|1.2||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.2|-1.0|0.821
73815557|NCT02051335|147180425|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.549||0.426|TWO_SIDED|95.0|-0.7|1.5||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.5|-0.7|0.426
73815558|NCT02051335|147180425|SUPERIORITY_OR_OTHER||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.53||0.126|TWO_SIDED|95.0|-0.2|1.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.9|-0.2|0.126
73815559|NCT02051335|147180426|SUPERIORITY_OR_OTHER||LS mean difference|1.93|STANDARD_ERROR_OF_MEAN|0.992||0.057|TWO_SIDED|95.0|-0.1|3.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||3.9|-0.1|0.057
73815560|NCT02051335|147180426|SUPERIORITY_OR_OTHER||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.981||0.394|TWO_SIDED|95.0|-2.8|1.1||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.1|-2.8|0.394
73815561|NCT02051335|147180426|SUPERIORITY_OR_OTHER||LS mean difference|2.01|STANDARD_ERROR_OF_MEAN|0.972||0.042|TWO_SIDED|95.0|0.1|4.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||4.0|0.1|0.042
73815562|NCT02051335|147180426|SUPERIORITY_OR_OTHER||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.974||0.928|TWO_SIDED|95.0|-1.9|2.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||2.0|-1.9|0.928
73815563|NCT02051335|147180426|SUPERIORITY_OR_OTHER||LS mean difference|2.86|STANDARD_ERROR_OF_MEAN|0.943||0.004|TWO_SIDED|95.0|1.0|4.7||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||4.7|1.0|0.004
73815564|NCT02134353|147180457|SUPERIORITY||Mean Difference (Net)|54.0||||0.02|TWO_SIDED|95.0|8.0|100.0|||Mixed Models Analysis||Missing data for withdrawals related to safety or efficacy imputed using BOCF (baseline observation carried forward). Data collected at 6, 14 and 26 weeks.|||100|8|0.020
73815565|NCT02134353|147180458|SUPERIORITY||Mean Difference (Net)|40.0||||0.128|TWO_SIDED|95.0|-12.0|92.0||Missing data for withdrawals due to safety/efficacy imputed using BOCF. Data collected at 6,14 and 26 weeks.|Mixed Models Analysis||Missing data for withdrawals related to safety or efficacy imputed using BOCF. Data collected at 6, 14 and 26 weeks.|||92|-12|0.128
73815566|NCT02134353|147180459|SUPERIORITY||Cox Proportional Hazard|1.14||||0.629|TWO_SIDED|95.0|0.671|1.936|||Regression, Cox|||||1.936|0.671|0.629
73815567|NCT02134353|147180460|SUPERIORITY||Rate ratio|0.75||||0.673|TWO_SIDED|95.0|0.198|2.846|||Negative binomial model|||||2.846|0.198|0.673
73815568|NCT02134353|147180461|SUPERIORITY||Rate ratio|1.273||||0.735|TWO_SIDED|95.0|0.315|5.154|||Negative binomial model|||||5.154|0.315|0.735
73815569|NCT02134353|147180462|SUPERIORITY||Rate ratio|1.545||||0.055|TWO_SIDED|95.0|0.99|2.411|||Negative binomial model|||Patients withdrawing early without an exacerbation had rate imputed based on number of exacerbations in 12 months prior to screening.||2.411|0.990|0.055
73815570|NCT02134353|147180462|SUPERIORITY||Rate ratio|1.357||||0.246|TWO_SIDED|95.0|0.81|2.275|||Negative binomial model|||Sensitivity analysis with no imputation of missing data.||2.275|0.810|0.246
73815571|NCT02134353|147180463|SUPERIORITY||Odds Ratio (OR)|1.009||||0.976|TWO_SIDED|95.0|0.555|1.836|||Regression, Logistic|||||1.836|0.555|0.976
73815572|NCT02134353|147180464|SUPERIORITY||Mean Difference (Net)|0.259||||0.083|TWO_SIDED|95.0|-0.034|0.551|||Mixed Models Analysis|Missing values due to withdrawal related to safety/efficacy imputed using BOCF||||0.551|-0.034|0.083
73815573|NCT02134353|147180465|SUPERIORITY||Mean Difference (Net)|0.87||||0.453|TWO_SIDED|95.0|-1.406|3.145|||Mixed Models Analysis||Missing values due to withdrawal related to safety/efficacy imputed using BOCF|||3.145|-1.406|0.453
73815574|NCT02134353|147180466|SUPERIORITY||Mean Difference (Net)|87.0||||0.012|TWO_SIDED|95.0|20.0|155.0|||Mixed Models Analysis||Missing data due to withdrawals for reasons related to safety/efficacy imputed using BOCF|||155|20|0.012
73815575|NCT00477607|147180467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.89|TWO_SIDED|95.0|0.4|11.4|||Fisher Exact|No adjustments. Right one-sided p-value.||H0: pr(Hearing loss arm 1) = pr(Hearing loss arm 2)||11.4|0.4|0.89
73815576|NCT00477607|147180468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.195|STANDARD_ERROR_OF_MEAN|0.3999||0.63|TWO_SIDED|95.0|-1.03|0.64|||t-test, 2 sided|||H0: mean (MDA arm 1) = mean (MDA Arm 2)||0.64|-1.03|0.63
73815577|NCT00477607|147180469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.2|STANDARD_ERROR_OF_MEAN|32.7||0.15|TWO_SIDED|95.0|-18.1|114.6|||t-test, 2 sided|||H0: mean(max dose arm 1) = mean(max dose arm 2)||114.6|-18.1|0.15
73815578|NCT01900431|147180535|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2354|TWO_SIDED|90.0|0.8|5.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using combined estimate for odds ratio obtained by combining the log-transformation of odds ratio from Cochran Mantel-Haenszel (CMH) analyses of the different imputed datasets, using Rubin's formulae, and then by back-transforming the combined estimate. The CMH analyses were adjusted for randomization stratification factor VH level (VH \>= 4 versus VH \<4).||5.6|0.8|0.2354
73815579|NCT01900431|147180536|SUPERIORITY||Least Square (LS) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0127|TWO_SIDED|90.0|-1.223|-0.262||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using mixed effect model with repeated measures (MMRM) with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline adjudicated VH.||-0.262|-1.223|0.0127
73815580|NCT01900431|147180537|SUPERIORITY||Odds Ratio (OR)|0.95||||1|TWO_SIDED|90.0|0.11|6.093||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH \>=4 versus VH \<4).||6.093|0.11|1
73815581|NCT01900431|147180538|SUPERIORITY||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|2.26||0.0153|TWO_SIDED|90.0|1.99|9.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA.||9.67|1.99|0.0153
73815582|NCT01900431|147180539|SUPERIORITY||LS Mean Difference|-26.5|STANDARD_ERROR_OF_MEAN|14.2||0.0683|TWO_SIDED|90.0|-50.41|-2.68||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).||-2.68|-50.41|0.0683
73815583|NCT01900431|147180540|SUPERIORITY||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|3.55||0.0825|TWO_SIDED|90.0|-12.374|-0.35||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).||-0.35|-12.374|0.0825
73815584|NCT01900431|147180543|SUPERIORITY||Odds Ratio (OR)|1.07||||1|TWO_SIDED|90.0|0.306|3.845||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH \>=4 versus VH \<4).||3.845|0.306|1
73815585|NCT00603382|147180578|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.101||||0.095|TWO_SIDED|95.0|-0.018|0.221|||ANCOVA|||||0.221|-0.018|0.095
73815586|NCT00603382|147180578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129||||0.033|TWO_SIDED|95.0|0.011|0.247|||ANCOVA|||||0.247|0.011|0.033
73815587|NCT00603382|147180578|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.204|||<|0.001|TWO_SIDED|95.0|0.089|0.319|||ANCOVA|||||0.319|0.089|<0.001
73815588|NCT00603382|147180578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001|TWO_SIDED|95.0|0.111|0.349|||ANCOVA|||||0.349|0.111|<0.001
73815589|NCT00603382|147180578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106||||0.074|TWO_SIDED|95.0|-0.01|0.223|||ANCOVA|||||0.223|-0.010|0.074
73815590|NCT03403621|147180609|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.42
73815591|NCT03403621|147180609|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.72
73815592|NCT03403621|147180609|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.51
73815593|NCT03403621|147180609|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.58
73815594|NCT03403621|147180610|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.03
73815595|NCT03403621|147180610|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.08
73815596|NCT03403621|147180610|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.02
73815597|NCT03403621|147180610|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.007
73815598|NCT03403621|147180611|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.21
73815599|NCT03403621|147180611|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.18
73815600|NCT03403621|147180611|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.33
73815601|NCT03403621|147180611|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.5
73815602|NCT01093651|147180613|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for CD4+ T-cell count over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|Study subject was included in these models as a random variable to account for within-participant correlation.||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in CD4+ T-cell count between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
73815603|NCT01093651|147180614|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for plasma HIV RNA copy number/mL over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in plasma HIV RNA copy number/mL between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
73815604|NCT01093651|147180615|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for serum TNFR2 levels over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum TNFR2 levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
73815605|NCT01093651|147180616|SUPERIORITY_OR_OTHER||||||<|0.0002||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for SDF1-alpha levels over time and between the 2 groups achieved p\<0.0002.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum SDF1α levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||<0.0002
73815606|NCT01093651|147180617|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for serum RANTES levels over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum RANTES levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
73815607|NCT01093651|147180618|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for area under the glucose tolerance curve over time and between the 2 groups achieved p\<0.04.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in area under the glucose tolerance curves between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||<0.04
73815608|NCT01093651|147180619|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The non-paramteric test for adverse event cummulative frequency between the 2 groups did not achieve p\<0.05 (not statistically significant)|Kruskal-Wallis|||Kruskal-Wallis non-parametric test of cell frequencies||||>0.05
73815609|NCT03611582|147180620|SUPERIORITY||Treatment difference|-10.27|||<|0.0001|TWO_SIDED|95.0|-11.97|-8.57|||ANCOVA|||Treatment policy estimand||-8.57|-11.97|<.0001
73815610|NCT03611582|147180620|SUPERIORITY||Treatment difference|-12.67|||<|0.0001|TWO_SIDED|95.0|-14.34|-11.0|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||-11.00|-14.34|<0.0001
73815611|NCT03611582|147180621|SUPERIORITY||Odds Ratio (OR)|6.11|||<|0.0001|TWO_SIDED|95.0|4.04|9.26|||Regression, Logistic|||Treatment policy estimand||9.26|4.04|<0.0001
73815612|NCT03611582|147180621|SUPERIORITY||Odds Ratio (OR)|11.67|||<|0.0001|TWO_SIDED|95.0|7.64|17.81|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||17.81|7.64|<0.0001
73815613|NCT01783821|147180651|SUPERIORITY_OR_OTHER|||||||0.02|||||||Type 3 Wald Test|||Overall p-value of the day by treatment interaction from the random effects model using a type 3 Wald test.||||0.02
73815614|NCT01783821|147180652|SUPERIORITY_OR_OTHER|||||||0.01|||||||Fisher Exact|||Comparison between the two arms for the 3 categories.||||0.01
73815615|NCT01783821|147180653|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.01
73815616|NCT01783821|147180654|SUPERIORITY_OR_OTHER|||||||0.01|||||||Fisher Exact|||||||0.01
73815617|NCT01783821|147180655|SUPERIORITY_OR_OTHER|||||||0.02|||||||Cox Proportional Hazard, Fine/Gray adj.|||||||0.02
73815618|NCT01783821|147180656|SUPERIORITY_OR_OTHER|||||||0.01|||||||Kruskal-Wallis|||||||0.01
73815619|NCT04459598|147180668|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|55.24|||||TWO_SIDED|90.0|45.24|67.46|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||67.46|45.24|
73815620|NCT04459598|147180668|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|32.37|||||TWO_SIDED|90.0|23.79|44.05|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||44.05|23.79|
73815621|NCT04459598|147180670|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|11.11|||||TWO_SIDED|90.0|8.47|14.56|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||14.56|8.47|
73815622|NCT04459598|147180670|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|3.67|||||TWO_SIDED|90.0|2.47|5.45|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||5.45|2.47|
73815623|NCT04459598|147180671|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|10.29|||||TWO_SIDED|90.0|7.73|13.7|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||13.70|7.73|
73815624|NCT04459598|147180671|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|3.88|||||TWO_SIDED|90.0|2.62|5.76|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||5.76|2.62|
73815625|NCT01907217|147180677|NON_INFERIORITY_OR_EQUIVALENCE|"The prespecified noninferiority margin was no more than a -4 point difference at the end of treatment between the bilateral and unilateral groups.~The predicted difference at the end of treatment was 1.08 (95% confidence interval \[CI\] = -1.67 to 3.84."|Mean Difference (Final Values)|1.08|||<|0.05|TWO_SIDED|95.0|-1.67|3.84||Primary statistical analysis was assessment of difference in HAM-D scores between arms at end-of-treatment, supplemented by 95% CIs and this interval compared with the pre-specified noninferiority threshold (-4 points). The p-value was calculated.|Regression, Linear|A regression model was fitted to end-of-treatment HAM-D measures, with baseline HAM-D scores, trial arm, randomization stratifiers as covariates.|The prespecified noninferiority margin was no more than a -4-point difference at the end of treatment between bitemporal and unilateral groups. The predicted difference at the end of treatment was 1.08 (95% confidence interval \[CI\]=-1.67 to 3.84).|Based on a large bitemporal ECT series, we estimated that 69 patients were required per group to have 80% power to demonstrate, using a one-sided equivalence t test at 5% level, that the mean reduction in the 24-item HAM-D score following high-dose unilateral ECT was no more than 4 points (i.e., equivalent to 3 points on the 17-item HAM-D, deemed to be clinically relevant \[30\]) less than that achieved using bitemporal ECT.||3.84|-1.67|<0.05
73815626|NCT01907217|147180678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.001|TWO_SIDED|95.0|0.51|0.85||As above|generalized linear models with a binomia|||"The AMI-SF at end of treatment was analyzed using generalized linear models with a binomial distribution and logit-link. Post treatment AMI-SF measures provide the number of baseline items recalled after ECT; such number of items recalled variables were therefore modeled as arising from binomial distributions, with maximum number of possible recalls set to the number of items obtained at baseline."||0.85|0.51|0.001
73815627|NCT01907217|147180679|SUPERIORITY||Odds Ratio (OR)|0.59||||0.001|TWO_SIDED|95.0|0.45|0.78|||Regression, Linear|Analyzed using a generalized linear models with a binomial distribution and logit-link.||||0.78|0.45|0.001
73815628|NCT01907217|147180680|SUPERIORITY||Odds Ratio (OR)|0.59||||0.001|TWO_SIDED|95.0|0.45|0.79|||Regression, Linear|generalized linear models with a binomial distribution and logit-link||||0.79|0.45|0.001
73815629|NCT01078298|147180681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.35|||<|0.0001|TWO_SIDED|95.0|2.16|5.21|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||5.21|2.16|<0.0001
73815630|NCT01078298|147180682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53||||0.0001|TWO_SIDED|95.0|1.56|4.1|||Regression, Logistic|||For Week 9 through 24, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.||4.10|1.56|0.0001
73815631|NCT01078298|147180682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0011|TWO_SIDED|95.0|1.4|3.98|||Regression, Logistic|||For Week 9 through 52, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.||3.98|1.40|0.0011
73815632|NCT01078298|147180683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.53|5.78|||Regression, Logistic|||For Week 12, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||5.78|2.53|<0.0001
73815633|NCT01078298|147180683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.0004|TWO_SIDED|95.0|1.4|3.33|||Regression, Logistic|||For Week 24, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.33|1.40|0.0004
73815634|NCT01078298|147180683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.002|TWO_SIDED|95.0|1.28|3.08|||Regression, Logistic|||For Week 52, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.08|1.28|0.0020
73815635|NCT01078298|147180684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97||||0.0027|TWO_SIDED|95.0|1.26|3.08|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.08|1.26|0.0027
73815636|NCT00350779|147180698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72|STANDARD_DEVIATION|0.87|<|0.001||95.0|-0.95|-0.49|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-0.49|-0.95|<0.001
73815637|NCT00350779|147180699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.0|STANDARD_DEVIATION|31.3|<|0.001||95.0|-27.2|-10.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-10.9|-27.2|<0.001
73815638|NCT00350779|147180700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.9|STANDARD_DEVIATION|43.7|<|0.001||95.0|-50.2|-25.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-25.5|-50.2|<0.001
73815639|NCT00350779|147180701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|STANDARD_DEVIATION|1.04|<|0.001||95.0|-1.04|-0.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-0.50|-1.04|<0.001
73815640|NCT00350779|147180702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.4|STANDARD_DEVIATION|34.6|<|0.001||95.0|-26.4|-8.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-8.4|-26.4|<0.001
73815641|NCT00350779|147180703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.1|STANDARD_DEVIATION|51.0|<|0.001||95.0|-48.4|-19.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-19.9|-48.4|<0.001
73815642|NCT01663857|147180716|SUPERIORITY|||||||0.4|||||||Log Rank|||||||0.4
73815643|NCT01663857|147180718|SUPERIORITY|||||||0.4686|||||||Log Rank|||||||0.4686
73815644|NCT04114656|147180721|OTHER||Posterior Ratio to placebo|0.993|||||TWO_SIDED|95.0|0.968|1.02|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.020|0.968|
73815645|NCT04114656|147180722|OTHER||Posterior ratio to placebo|1.0|||||TWO_SIDED|95.0|0.89|1.12|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.12|0.89|
73815646|NCT04114656|147180723|OTHER||Posterior ratio to placebo|0.98|||||TWO_SIDED|95.0|0.91|1.05|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.05|0.91|
73815647|NCT03052920|147180724|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<=0.05|t-test, 2 sided|t(35) = 11.29||Mean difference in percent correct for CNC words at 6 months post-implant and pre-implant is reported.||||<0.001
73815648|NCT03052920|147180725|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<=0.05|t-test, 2 sided|t(35) = 16.947||Mean difference in Soundfield thresholds (averaged across the frequency range in dB HL) at 6 months post-implant and pre-implant is reported.||||<0.001
73815649|NCT03052920|147180726|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05|t-test, 2 sided|t(35) = 2.14||Mean difference in degrees RMS error at 6 months post-implant and pre-implant is reported.||||<0.05
73815650|NCT03052920|147180727|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 4.02||Mean difference in percentage of understanding (words correct) at 6 months post-implant and pre-implant is reported.||||<0.001
73815651|NCT03052920|147180728|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 2.58||Mean difference in AzBio sentence scores in noise at 6 months post-implant and pre-implant is reported.||||<0.05
73815652|NCT03052920|147180729|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 3.16||Mean difference in dB SNR for BKB-SIN sentences with noise to the better ear at 6-months post-implant and pre-implant is reported.||||<0.01
73815653|NCT03052920|147180730|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 10.42||Mean difference in AzBio sentence scores at 60 dB SPL for the poor ear alone at 6 months post-implant and pre-implant is reported.||||<0.001
73815654|NCT03052920|147180731|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.15||Mean difference in HHIE reported scores at 6-months post-implant and pre-implant is reported.||||<0.001
73815655|NCT03052920|147180732|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 4.34||Mean difference in HUI3 ratings at 6 months post-implant and pre-implant is reported.||||<0.001
73815656|NCT03052920|147180733|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.71||Mean difference in ratings for the SSQ total score at 6 months post-implant and pre-implant is reported.||||<0.001
73815657|NCT03052920|147180734|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.90||Mean difference in SSQ ratings at 12 months post-implant and pre-implant is reported.||||<0.001
73815658|NCT03052920|147180735|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 2.31||Mean difference in SADL scores at 6 months post-implant and pre-implant are reported.||||<0.05
73815659|NCT03052920|147180736|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(25) = 7.27||Mean difference in the CPHI scores at 6 months post-implant and pre-implant are reported.||||<0.001
73815660|NCT03052920|147180737|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(25) = 7.65||Mean difference in HII-SOP scores at 6 months post-implant and pre-implant is reported.||||<0.001
73815661|NCT03052920|147180738|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 2.34||Mean difference in the dB SNR scores for BKB-SIN sentences at 6 months post-implant minus pre-implant is reported.||||<0.05
73815662|NCT03282591|147180739|SUPERIORITY||Mean Difference (Final Values)|31.4||||0.9942|ONE_SIDED|95.0||56.9|||Mixed Models Analysis|||||56.9||0.9942
73815663|NCT04165135|147180805|OTHER|||||||0.763|||||||Kruskal-Wallis|||Heart zone minutes: Comparison among the age groups was performed by means of a Kruskal-Wallis test.||||0.7630
73815664|NCT04165135|147180805|OTHER|||||||0.0913|||||||Kruskal-Wallis|||Active zone minutes: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0913
73815665|NCT04165135|147180805|OTHER|||||||0.0956|||||||Kruskal-Wallis|||MVPA minutes: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0956
73815666|NCT04165135|147180806|OTHER|||||||0.0649|||||||Kruskal-Wallis|||||||0.0649
73815667|NCT04165135|147180807|OTHER|||||||0.0026|||||||Kruskal-Wallis|||||||0.0026
73815668|NCT04165135|147180808|OTHER|||||||0.9493|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9493
73815669|NCT04165135|147180808|OTHER|||||||0.8305|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.8305
73815670|NCT04165135|147180808|OTHER|||||||0.8725|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.8725
73815671|NCT04165135|147180808|OTHER|||||||0.338|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.3380
73815672|NCT04165135|147180808|OTHER|||||||0.9706|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9706
73815673|NCT04165135|147180808|OTHER|||||||0.1727|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1727
73815674|NCT04165135|147180808|OTHER|||||||0.0099|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0099
73815675|NCT04165135|147180809|OTHER|||||||0.6151|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.6151
73815676|NCT04165135|147180809|OTHER|||||||0.9332|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9332
73815677|NCT04165135|147180809|OTHER|||||||0.4726|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4726
73815678|NCT04165135|147180809|OTHER|||||||0.4111|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4111
73815679|NCT04165135|147180809|OTHER|||||||0.0892|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0892
73815680|NCT04165135|147180809|OTHER|||||||0.1642|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1642
73815681|NCT04165135|147180809|OTHER|||||||0.7256|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.7256
73815682|NCT04165135|147180810|OTHER|||||||0.0745|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0745
73815683|NCT04165135|147180810|OTHER|||||||0.2177|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2177
73815684|NCT04165135|147180810|OTHER|||||||0.2121|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2121
73815685|NCT04165135|147180810|OTHER|||||||0.2336|||||||Kruskal-Wallis|||Gym weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2336
73815686|NCT04165135|147180810|OTHER|||||||0.419|||||||Kruskal-Wallis|||Exercises at intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4190
73815687|NCT04165135|147180810|OTHER|||||||0.0252|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0252
73815688|NCT04165135|147180810|OTHER|||||||0.2143|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2143
73815689|NCT04165135|147180811|OTHER|||||||0.0085|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0085
73815690|NCT04165135|147180811|OTHER|||||||0.1098|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1098
73815691|NCT04165135|147180811|OTHER|||||||0.2703|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2703
73815692|NCT04165135|147180811|OTHER|||||||0.3366|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.3366
73815693|NCT04165135|147180811|OTHER|||||||0.0992|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0992
73815694|NCT04165135|147180811|OTHER|||||||0.1194|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1194
73815695|NCT04165135|147180811|OTHER|||||||0.0549|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0549
73815696|NCT04165135|147180812|OTHER|||||||0.0088|||||||Chi-squared|||Comparison among age groups was performed using Chi-squared test.||||0.0088
73815697|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.92|||<|0.001||90.0|-63.84|-35.99|||Mixed Effects Model Analysis|P-value is for Day 43.||||-35.99|-63.84|<0.001
73815698|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.85|||<|0.001||90.0|-48.78|-20.93|||Mixed Effects Model Analysis|P-value is for Day 57.||||-20.93|-48.78|<0.001
73815699|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-47.72|||<|0.001||90.0|-62.1|-33.34|||Mixed Effects Model Analysis|P-value is for Day 43.||||-33.34|-62.10|<0.001
73815700|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.26|||<|0.001||90.0|-46.69|-17.82|||Mixed Effects Model Analysis|P-value is for Day 57.||||-17.82|-46.69|<0.001
73815701|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.36|||<|0.001||90.0|-60.07|-30.64|||Mixed Effects Model Analysis|P-value is for Day 43.||||-30.64|-60.07|<0.001
73815702|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.04|||<|0.001||90.0|-46.76|-17.32|||Mixed Effects Model Analysis|P-value is for Day 57.||||-17.32|-46.76|<0.001
73815703|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.8|||<|0.001||90.0|-61.12|-32.49|||Mixed Effects Model Analysis|P-value is for Day 43.||||-32.49|-61.12|<0.001
73815704|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-44.64|||<|0.001||90.0|-58.95|-30.32|||Mixed Effects Model Analysis|P-value is for Day 57.||||-30.32|-58.95|<0.001
73815705|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.53||||0.44||90.0|-20.51|7.44|||Mixed Effect Model Analysis|P-value is for Day 127||||7.44|-20.51|0.440
73815706|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.1||||0.108||90.0|-28.53|0.33|||Mixed Effect Model Analysis|P-value is for Day 127.||||0.33|-28.53|0.108
73815707|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.41||||0.013||90.0|-37.13|-7.69|||Mixed Effect Model Analysis|P-value is for Day 127.||||-7.69|-37.13|0.013
73815708|NCT01618916|147180866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.93||||0.042||90.0|-32.42|-3.44|||Mixed Effect Model Analysis|P-value is for Day 127.||||-3.44|-32.42|0.042
73896498|NCT00913458|147326244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.19||||0.0016|TWO_SIDED|95.0|-21.3|-5.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-5.1|-21.3|0.0016
73815709|NCT04000360|147180894|SUPERIORITY||Difference in slopes.|-3.62|STANDARD_ERROR_OF_MEAN|0.91|<|0.0001|TWO_SIDED|95.0|-5.4|-1.85||This was the sole primary outcome. The test was conducted with a priori p-value threshold of α=0.05, with no multiple comparison adjustment.|Mixed Models Analysis|Test of equality of slopes with time (change in points/year) between aerobic exercise (AE) and usual and customary care (UCC) treatment arms.|Higher MDS-UPDRS III score reflects worse Parkinson's symptoms; increases reflect PD progression. The reported effect is the estimated difference between annual rates of change in scores of AE and UCC patients.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and AR(1) covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX.||-1.85|-5.40|<0.0001
73815710|NCT04000360|147180895|SUPERIORITY|Equality of annual slopes in squared 10 Meter Walk Test Comfortable Pace Velocity for the AE and UCC groups.|Difference in squared velocity slopes|12.07|STANDARD_ERROR_OF_MEAN|4.65||0.043|TWO_SIDED|95.0|3.1|21.32||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 Meter Walk Test fast pace velocity, TUG duration \& turning velocity, Manual Dexterity Test.|Mixed Models Analysis||The reported effect is the difference in annual slope of meters\^2/second, in 100ths of meters\^2/second/year. The confidence interval is not multiple comparison adjusted. Parkinson's progression limits mobility; higher slope reflects less progression.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test velocity was squared ((meters/second)\^2) for modeling. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||21.32|3.10|0.043
73815711|NCT04000360|147180896|SUPERIORITY|Equality of annual slopes in 10 Meter Walk Test Fast Pace Velocity for the AE and UCC groups.|Difference in slopes|3.16|STANDARD_ERROR_OF_MEAN|2.68||0.48|TWO_SIDED|95.0|-2.1|8.42||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable pace, Timed Up and Go Test duration and turning velocity, Manual Dexterity Test.|Mixed Models Analysis||The reported effect is the difference in annual slopes of the AE and UCC treatment arms, in 100ths of meters/second/year. The confidence interval is not multiple comparison adjusted. Higher slope reflects less Parkinson's disease progression.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and heterogeneous compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX.||8.42|-2.10|0.48
73815712|NCT04000360|147180897|SUPERIORITY|Equality of annual slopes of inverse Timed Up and Go Test duration, i.e., of TUG completions/second, the speed of completing the test.|Difference in slopes|4.04|STANDARD_ERROR_OF_MEAN|1.96||0.16|TWO_SIDED|95.0|0.2|7.89||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable \& fast pace, Timed Up and Go Test turning velocity, and Manual Dexterity Test.|Mixed Models Analysis|Difference between estimated annual slopes in TUG completions/second/year for the AE and UCC groups.|Timed Up and Go test speed is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a TUG completion/second/year.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was inverted to TUG completions/second. Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||7.89|0.20|0.16
73815713|NCT04000360|147180898|SUPERIORITY|Test of equality of average turning velocities.|Difference in slopes.|1.85|STANDARD_ERROR_OF_MEAN|1.54||0.69|TWO_SIDED|95.0|-1.17|4.88||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable \& fast pace, Timed Up and Go Test duration, and Manual Dexterity Test.|Mixed Models Analysis||Timed Up and Go test speed is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes of average turning velocity for the AE and UCC groups in degrees/second/year.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||4.88|-1.17|0.69
73815714|NCT04000360|147180899|SUPERIORITY|Test of equality of slopes of test performance speed (peg transfers/second/year) for AE and UCC groups.|Difference in slopes.|-3.62|STANDARD_ERROR_OF_MEAN|10.23||0.72|TWO_SIDED|95.0|-23.68|16.45||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: Timed Up and Go Test (TUG) duration \& turning velocity and 10 meter walk test comfortable \& fast pace.|Mixed Models Analysis||Manual dexterity expressed as peg transfers/second is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a peg transfer/second/year.|Linear mixed model for baseline, 6 and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was transformed for modeling to peg transfers/second (18/seconds). Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||16.45|-23.68|0.72
73896499|NCT00913458|147326244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83||||0.0348|TWO_SIDED|95.0|-17.0|-0.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.6|-17.0|0.0348
73896500|NCT00913458|147326245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.51||||0.1248|TWO_SIDED|95.0|-12.6|1.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||1.6|-12.6|0.1248
73815715|NCT04000360|147180900|SUPERIORITY|Test of equality of slopes of squared match scores (matches\^2/year) between AE and UCC groups.|Difference in slopes.|-96.91|STANDARD_ERROR_OF_MEAN|69.12||0.48|TWO_SIDED|95.0|-232.41|38.6||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Visual Memory Test and Trail Making Test B to A duration ratio.|Mixed Models Analysis||Processing speed is expected to decline with Parkinson's, hence duration of the test to increase. The reported effect is the difference in annual slopes (matches\^2/year) between the AE and UCC treatment arms.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and heterogeneous compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was squared (matches\^2) for analysis. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||38.60|-232.41|0.48
73815716|NCT04000360|147180901|SUPERIORITY|Test of equality of annual slopes of log(TMT B to TMT A duration ratio) for AE and UCC groups.|Difference in slopes|-3.42|STANDARD_ERROR_OF_MEAN|6.06||1|TWO_SIDED|95.0|-15.31|8.46||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Processing Speed Test and Visual Memory Test.|Mixed Models Analysis||Visual attention and set switching speed decline with Parkinson's, hence duration of Trail Making Test B increases. The reported effect is the difference in annual slopes of (log TMT B/TMT A), i.e., change/year, between AE and UCC treatment arms.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, the ratios were transformed to their natural logarithms for modeling. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||8.46|-15.31|1.00
73815717|NCT04000360|147180902|SUPERIORITY|Test of equality of annual slopes of squared test score.|Difference in slopes|0.16|STANDARD_ERROR_OF_MEAN|1.4||0.91|TWO_SIDED|95.0|-2.58|2.91||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Processing Speed Test and Trail Making Test Ratio.|Mixed Models Analysis||Visual memory declines with Parkinson's, hence the score declines. The reported effect is the difference in annual slopes, i.e., changes in mean score\^2/year, for AE and UCC treatment arms, shown in hundreds. Higher slope indicates slower decline.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, the score was squared for statistical modeling. Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||2.91|-2.58|0.91
73815718|NCT03725033|147180917|SUPERIORITY|||||||0.0028|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.0028
73815719|NCT03725033|147180918|SUPERIORITY|||||||0.0805|||||||Fisher Exact|||||||0.0805
73815720|NCT03725033|147180919|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.99
73815721|NCT03725033|147180920|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.79
73815722|NCT01625689|147180924|SUPERIORITY_OR_OTHER||||||>=|0.498|TWO_SIDED|||||No comparison between the LAIV and placebo groups by type of solicited reaction had a p-value below 0.498.|Fisher Exact|||||||>=0.498
73815723|NCT03782974|147181021|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.104|<|0.0001|TWO_SIDED|95.0|-0.77|-0.37||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||-0.37|-0.77|<0.0001
73815724|NCT03782974|147181022|SUPERIORITY||Risk Difference (RD)|0.27|||<|0.0001|TWO_SIDED|95.0|0.1|0.59||The threshold for statistical significance was p=0.05.|Chi-squared|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||0.59|0.10|<0.0001
73815725|NCT03782974|147181023|SUPERIORITY||Least Square Mean Difference|6.35|||<|0.001|TWO_SIDED|95.0|3.93|8.77||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||8.77|3.93|<0.001
73815726|NCT03782974|147181024|SUPERIORITY||Least Square Mean Difference|4.049|||<|0.05|TWO_SIDED|95.0|1.08|7.01||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||7.01|1.08|<0.05
73815727|NCT03782974|147181025|SUPERIORITY|||||||0.6||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.6
73815728|NCT03782974|147181026|SUPERIORITY|||||||0.054||||||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||||0.054
73815729|NCT03782974|147181027|SUPERIORITY|||||||0.13||||||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||||0.13
73815730|NCT03782974|147181028|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.96|-0.56||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||-0.56|-0.96|<0.0001
73815731|NCT02993354|147181036|SUPERIORITY||Relative Rate|0.95||||0.75|TWO_SIDED|95.0|0.69|1.31|||t-test, 2 sided|||||1.31|0.69|0.75
73815732|NCT03704948|147181040|SUPERIORITY||Mean Difference (Net)|0.82|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
73815733|NCT01180049|147181050|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.731|||||TWO_SIDED|80.0|0.52|1.027||||||||1.027|0.520|
73815734|NCT01180049|147181051|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.778|||||TWO_SIDED|80.0|0.568|1.064||||||||1.064|0.568|
73815735|NCT01180049|147181052|SUPERIORITY_OR_OTHER||Difference in arms|6.7|||||TWO_SIDED|80.0|-6.9|20.3||||||Independent assessment- Difference (%) TEMSR 175/75 mg - TEMSR 75 mg (80% CI)||20.3|-6.9|
73815736|NCT01180049|147181053|SUPERIORITY_OR_OTHER||Difference between arms|13.3|||||TWO_SIDED|80.0|-0.4|26.7||||||Investigator's assessment- Difference (%)TEMSR 175/75 mg - TEMSR 75 mg (80% CI)||26.7|-0.4|
73815737|NCT01180049|147181054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.646|||||TWO_SIDED|80.0|0.453|0.922||||||||0.922|0.453|
73815738|NCT00564278|147181121|SUPERIORITY_OR_OTHER_LEGACY||GEE model Beta|17.46||||0.26|TWO_SIDED|95.0|-16.61|51.53||All analyses presented are at 9 months.|t-test, 2 sided|t(193) = -1.14, p=.26||"We also conducted an analysis using a Generalized Estimating Equations model adjusting for a number of covariates.~We will conduct a three-part regression analysis assessing early/middle/late effects of MPT on retention. We will also conduct moderator analyses, as described in the original study grant, to determine whether there are specific patient groups for whom a significant difference in days in treatment is found."||51.53|-16.61|0.26
73815739|NCT00564278|147181122|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|-0.28|||||TWO_SIDED|95.0|-1.57|1.01||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline depressive symptoms and time to assess the effect of MADT vs. SADT on mean depressive symptoms over follow-up.|||1.01|-1.57|
73815740|NCT00564278|147181123|SUPERIORITY_OR_OTHER_LEGACY||Work - Mixed Model Beta for MADT vs SADT|0.22|||||TWO_SIDED|95.0|-0.5|0.95||See under Method of Estimation, below|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline work-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the work domain over follow-up.|||0.95|-0.50|
73815741|NCT00564278|147181123|SUPERIORITY_OR_OTHER_LEGACY||Social-Mixed Model Beta for MADT vs SADT|0.22|||||TWO_SIDED|95.0|-0.49|0.92||See under Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline social-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the social domain over follow-up.|||0.92|-0.49|
73815742|NCT00564278|147181123|SUPERIORITY_OR_OTHER_LEGACY||Family-Mixed Model Beta for MADT vs SADT|0.55|||||TWO_SIDED|95.0|-0.08|1.18||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline family-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the family domain over follow-up.|||1.18|-0.08|
73815743|NCT00564278|147181124|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|0.02|||||TWO_SIDED|95.0|-3.61|3.64||See Method of Estimation, below|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline QOL score and time to assess the effect of MADT vs. SADT on mean percent of quality of life over follow-up.|||3.64|-3.61|
73815744|NCT00564278|147181125|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|-0.04|||||TWO_SIDED|95.0|-0.74|0.66||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline patient satisfaction and time to assess the effect of MADT vs. SADT on mean patient satisfaction over follow-up.|||0.66|-0.74|
73815745|NCT00564278|147181126|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|9.14|||||TWO_SIDED|95.0|2.71|15.57||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician to model the effect of MPT vs. SADT on the mean proportion of fully adherent days over the study period. We used an exchangeable covariance structure.|||15.57|2.71|
73815746|NCT02368886|147181133|SUPERIORITY||Risk Difference (RD)|0.17||||0.0434|TWO_SIDED|95.0|0.0|0.34||1-sided|Fisher Exact|||||0.34|0.00|0.0434
73815747|NCT02368886|147181134|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1241|TWO_SIDED|95.0|0.47|1.1|||Log Rank|||||1.10|0.47|0.1241
73815748|NCT02368886|147181135|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3797|TWO_SIDED|95.0|0.57|1.24|||Log Rank|||||1.24|0.57|0.3797
73815749|NCT02368886|147181136|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4614|TWO_SIDED|95.0|0.55|1.31|||Log Rank|||||1.31|0.55|0.4614
73815750|NCT02368886|147181141|SUPERIORITY|||||||0.7319|||||||Kruskal-Wallis|||||||0.7319
73815751|NCT02173379|147181161|NON_INFERIORITY|One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 2.9%, to be compared with a one-sided significance level of 0.025.||||||0.0244|ONE_SIDED|97.5|||||Farrington-Manning|||"The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the primary endpoint with a one-sided alpha of 0.025. The null (H0) and alternative (HA) hypotheses are:~H0: TLFAbsorb - TLFXIENCE ≥ ∆TLF HA: TLFAbsorb - TLFXIENCE \< ∆TLF."||||0.0244
73815752|NCT02173379|147181162|NON_INFERIORITY|One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.||||||0.0006|||||||Farrington-Manning|||||||0.0006
73815753|NCT04997265|147181335|OTHER|Given the small sample size, simple descriptive were used. Between-group differences were performed using a Fisher exact test.|||||<|0.05|||||||Fisher Exact|||||||<0.05
73896501|NCT00913458|147326245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.14||||0.0004|TWO_SIDED|95.0|-21.8|-6.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-6.5|-21.8|0.0004
73896502|NCT00913458|147326245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.63||||0.0306|TWO_SIDED|95.0|-16.4|-0.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.8|-16.4|0.0306
73896503|NCT00913458|147326246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.4717|TWO_SIDED|95.0|0.5|4.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.6|0.5|0.4717
73815754|NCT02290925|147181365|OTHER|general linear model (GLM) with repeated measures|Mean Difference (Net)|0.25|||||TWO_SIDED||||||||Box's M tests was used. Mauchly's test was used to verify that the error covariance matrix of the orthonormalized-transformed dependent variables is proportional to an identity matrix.||"We used intention to treat analysis. Since the missing data were more than 5%, we examined the dataset to determine whether it shows missing completely at random (MCAR) not missing at random (NMAR) or data missing at random (MAR). A sensitivity analysis was done to determine whether multiple imputations are required. It included complete case analysis, best-worst case and worst best case scenario with group mean±1SD."|||
73815755|NCT04942210|147181369|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-5%|Difference in percentage of participants|0.3|||||TWO_SIDED|95.0|-1.2|3.2|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||3.2|-1.2|
73815756|NCT01410240|147181429|SUPERIORITY_OR_OTHER|||||||0.453|||||||one-sided, two-sample t-test|||||||0.453
73815757|NCT01410240|147181430|SUPERIORITY_OR_OTHER|||||||0.708|||||||one-sided, two-sample t-test|||||||0.708
73815758|NCT01410240|147181431|SUPERIORITY_OR_OTHER|||||||0.527|||||||one-sided, two-sample t-test|||||||0.527
73815759|NCT01410240|147181432|SUPERIORITY_OR_OTHER|||||||0.561|||||||one-sided Wilcoxon rank sum test|||||||0.561
73815760|NCT01410240|147181433|SUPERIORITY_OR_OTHER|||||||0.356|||||||one-sided Wilcoxon rank sum test|||||||0.356
73815761|NCT01410240|147181434|SUPERIORITY_OR_OTHER|||||||0.533|||||||one-sided Wilcoxon rank sum test|||||||0.533
73815762|NCT01410240|147181435|SUPERIORITY_OR_OTHER|||||||0.734|||||||two-sided Wilcoxon rank sum test|||||||0.734
73815763|NCT01410240|147181438|SUPERIORITY_OR_OTHER|||||||0.314|||||||two-sided Wilcoxon rank sum test|||||||0.314
73815764|NCT01410240|147181439|SUPERIORITY_OR_OTHER|||||||0.063|||||||two-sided Wilcoxon rank sum test|||||||0.063
73815765|NCT01410240|147181442|SUPERIORITY_OR_OTHER|||||||0.058|||||||two-sided Wilcoxon rank sum test|||||||0.058
73815766|NCT01410240|147181443|SUPERIORITY_OR_OTHER|||||||0.421|||||||two-sided Wilcoxon rank sum test|||||||0.421
73815767|NCT01410240|147181444|SUPERIORITY_OR_OTHER|||||||0.161|||||||two-sided Wilcoxon rank sum test|||||||0.161
73815768|NCT01410240|147181445|SUPERIORITY_OR_OTHER|||||||0.016|||||||two-sided Wilcoxon rank sum test|||||||0.016
73815769|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.534|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Pain||||0.534
73815770|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.269|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Stiffness||||0.269
73815771|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.693|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Physical Functioning||||0.693
73815772|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Average Score||||0.343
73815773|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Total Score||||0.343
73815774|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.978|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Pain||||0.978
73815775|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.709|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Stiffness||||0.709
73815776|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.594|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning||||0.594
73815777|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Average Score||||0.501
73815778|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Total Score||||0.501
73815779|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.171|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Pain||||0.171
73815780|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.077|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Stiffness||||0.077
73815781|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.026|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning||||0.026
73815782|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Average Score||||0.012
73815783|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Total Score||||0.012
73815784|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.126|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Pain||||0.126
73815785|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.044|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Stiffness||||0.044
73815786|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.153||||||Change Week 6: Physical Functioning|two-sided Wilcoxon rank sum test|||||||0.153
73815787|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Average Score||||0.134
73815788|NCT01410240|147181447|SUPERIORITY_OR_OTHER|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Total Score||||0.134
73815789|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.962|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning||||0.962
73815790|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.714|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Physical||||0.714
73815791|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.668|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Bodily Pain||||0.668
73815792|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.556|||||||two-sided Wilcoxon rank sum test|||Change Week 1: General Health||||0.556
73815793|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.705|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Vitality||||0.705
73815794|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.122|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Social Functioning||||0.122
73815795|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.254|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Emotional||||0.254
73815796|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.5|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Mental Health||||0.500
73815797|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.849|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Component Summary||||0.849
73815798|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||Change Week 1: Mental Component Summary||||0.959
73815799|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.574|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning||||0.574
73815800|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.524|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Physical||||0.524
73815801|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.049|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Bodily Pain||||0.049
73815802|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.447|||||||two-sided Wilcoxon rank sum test|||Change Week 2: General Health||||0.447
73815803|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.823|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Vitality||||0.823
73815804|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.661|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Social Functioning||||0.661
73815805|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.086|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Emotional||||0.086
73815806|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.635|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Health||||0.635
73815807|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.481|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Component Summary||||0.481
73815808|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.14|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Component Summary||||0.140
73815809|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.107|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Functioning||||0.107
73815810|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.298|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Physical||||0.298
73815811|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.071|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Bodily Pain||||0.071
73815812|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.94|||||||two-sided Wilcoxon rank sum test|||Change Week 6: General Health||||0.940
73815813|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.293|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Vitality||||0.293
73815814|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.265|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Social Functioning||||0.265
73815815|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.036|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Emotional||||0.036
73815816|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.307|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Health||||0.307
73815817|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.448|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Component Summary||||0.448
73815818|NCT01410240|147181449|SUPERIORITY_OR_OTHER|||||||0.255|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Component Summary||||0.255
73815819|NCT01410240|147181451|SUPERIORITY_OR_OTHER|||||||0.052|||||||two-sided Wilcoxon rank sum test|||||||0.052
73815820|NCT02776670|147181463|NON_INFERIORITY|Noninferiority was deemed established if the lower limit of the 95% CI (equivalent to the 1-sided 97.5% CI) for the adjusted estimate of the difference (Systane Balance-Refresh Optive Advanced/Optive Plus) was above the noninferiority margin of -1.0 second.|Mean Difference (Final Values)|0.13|||<|0.0001|TWO_SIDED|95.0|-0.341|0.601||p-value for testing noninferiority of Systane Balance with respect to Refresh Optive Advanced/Refresh Optive Plus is calculated for predefined noninferiority margin of -1.0 second.|Mixed model repeated measures (MMRM)|||||0.601|-0.341|<0.0001
73815821|NCT02776670|147181464|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.31|TWO_SIDED|95.0|-0.349|0.585|||MMRM|||||0.585|-0.349|0.310
73815822|NCT02776670|147181466|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.618|TWO_SIDED|95.0|-6.4|4.7|||MMRM|||||4.7|-6.4|0.618
73815823|NCT00592592|147181500|OTHER||Cumulative incidence|10.9|||||TWO_SIDED|95.0|5.7|18.0||||||||18.0|5.7|
73815824|NCT00592592|147181502|OTHER||% hypothalamus normal tissue spared|88.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
73815825|NCT00592592|147181502|OTHER||% pituitary normal tissue spared|73.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
73815826|NCT00592592|147181502|OTHER||% lens (contra) normal tissue spared|100.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
73815827|NCT00592592|147181502|OTHER||% maxilla normal tissue spared|42.0||||0.02|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.02
73815828|NCT00592592|147181503|OTHER||Percent Survival, Local Control|80.9|||||TWO_SIDED|95.0|73.0|87.7||||||||87.7|73.0|
73815829|NCT00938587|147181530|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.291||0.0141|TWO_SIDED|90.0|-1.21|-0.24|||MMRM|||Day 14: Treatment difference and its corresponding 90 percent (%) confidence interval (CI) was based on least squares (LS) mean difference using mixed-model repeated measure (MMRM) where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and compound symmetry (CS) as covariance structure.||-0.24|-1.21|0.0141
73815830|NCT00938587|147181530|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.283|<|0.0001|TWO_SIDED|90.0|-1.73|-0.79|||MMRM|||Day 14: Treatment difference and its corresponding 90 % CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.79|-1.73|<0.0001
73815831|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.865||0.437|TWO_SIDED|90.0|-4.54|1.63|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.63|-4.54|0.4370
73815832|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.858||0.1802|TWO_SIDED|90.0|-5.58|0.57|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.57|-5.58|0.1802
73815833|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.832||0.6012|TWO_SIDED|90.0|-3.99|2.07|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.07|-3.99|0.6012
73815834|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.834||0.2753|TWO_SIDED|90.0|-5.04|1.03|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.03|-5.04|0.2753
73815835|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|1.844||0.7892|TWO_SIDED|90.0|-2.56|3.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.55|-2.56|0.7892
73815836|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|1.937||0.3765|TWO_SIDED|90.0|-4.92|1.49|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.49|-4.92|0.3765
73815837|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.59|STANDARD_ERROR_OF_MEAN|1.873||0.0571|TWO_SIDED|90.0|-6.69|-0.49|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.49|-6.69|0.0571
73815838|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|1.896||0.6553|TWO_SIDED|90.0|-3.99|2.29|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.29|-3.99|0.6553
73815839|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.72|STANDARD_ERROR_OF_MEAN|1.847||0.1427|TWO_SIDED|90.0|-5.78|0.33|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.33|-5.78|0.1427
73815840|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|1.873||0.643|TWO_SIDED|90.0|-2.23|3.97|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.97|-2.23|0.6430
73815841|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|1.918||0.5868|TWO_SIDED|90.0|-2.13|4.22|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.22|-2.13|0.5868
73815842|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|1.873||0.586|TWO_SIDED|90.0|-4.12|2.08|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.08|-4.12|0.5860
73815843|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.84|STANDARD_ERROR_OF_MEAN|1.879||0.3288|TWO_SIDED|90.0|-1.27|4.95|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.95|-1.27|0.3288
73815844|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|1.846||0.9027|TWO_SIDED|90.0|-3.28|2.83|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.83|-3.28|0.9027
73815845|NCT00938587|147181531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|1.871||0.671|TWO_SIDED|90.0|-2.3|3.89|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.89|-2.30|0.6710
73815846|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|1.123||0.837|TWO_SIDED|90.0|-1.63|2.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.09|-1.63|0.8370
73815847|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.96|STANDARD_ERROR_OF_MEAN|1.12||0.0819|TWO_SIDED|90.0|-3.81|-0.11|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.11|-3.81|0.0819
73815848|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|1.106||0.8892|TWO_SIDED|90.0|-1.98|1.67|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.67|-1.98|0.8892
73815849|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.35|STANDARD_ERROR_OF_MEAN|1.106||0.0353|TWO_SIDED|90.0|-4.17|-0.52|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.52|-4.17|0.0353
73815850|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.108||0.7283|TWO_SIDED|90.0|-2.22|1.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.45|-2.22|0.7283
73815851|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|1.174||0.9083|TWO_SIDED|90.0|-1.81|2.08|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.08|-1.81|0.9083
73815852|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.132||0.1641|TWO_SIDED|90.0|-3.45|0.29|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.29|-3.45|0.1641
73815853|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|1.155||0.817|TWO_SIDED|90.0|-1.64|2.18|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.18|-1.64|0.8170
73815854|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.116||0.1958|TWO_SIDED|90.0|-3.29|0.4|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.40|-3.29|0.1958
73815855|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.13||0.907|TWO_SIDED|90.0|-1.74|2.0|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.00|-1.74|0.9070
73815856|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.58|STANDARD_ERROR_OF_MEAN|1.16||0.0023|TWO_SIDED|90.0|1.67|5.5|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.50|1.67|0.0023
73815857|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|1.132||0.1531|TWO_SIDED|90.0|-0.25|3.49|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.49|-0.25|0.1531
73815858|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.65|STANDARD_ERROR_OF_MEAN|1.141||0.1506|TWO_SIDED|90.0|-0.24|3.53|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.53|-0.24|0.1506
73815859|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|1.116||0.78|TWO_SIDED|90.0|-2.16|1.53|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.53|-2.16|0.7800
73815860|NCT00938587|147181532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|1.13||0.0883|TWO_SIDED|90.0|-3.8|-0.07|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.07|-3.80|0.0883
73815861|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.47|STANDARD_ERROR_OF_MEAN|4.48||0.0599|TWO_SIDED|90.0|-15.87|-1.07|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-1.07|-15.87|0.0599
73815862|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.29|STANDARD_ERROR_OF_MEAN|4.436||0.003|TWO_SIDED|90.0|-20.61|-5.96|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.96|-20.61|0.0030
73815863|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.63|STANDARD_ERROR_OF_MEAN|4.483||0.0053|TWO_SIDED|90.0|-20.03|-5.22|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.22|-20.03|0.0053
73815864|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.44|STANDARD_ERROR_OF_MEAN|4.445||0.0001|TWO_SIDED|90.0|-24.78|-10.1|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-10.10|-24.78|0.0001
73815865|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.15|STANDARD_ERROR_OF_MEAN|4.427||0.3492|TWO_SIDED|90.0|-11.46|3.16|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.16|-11.46|0.3492
73815866|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.68|STANDARD_ERROR_OF_MEAN|4.661||0.0389|TWO_SIDED|90.0|-17.38|-1.98|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure||-1.98|-17.38|0.0389
73815867|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.1|STANDARD_ERROR_OF_MEAN|4.49||0.0142|TWO_SIDED|90.0|-18.51|-3.68|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-3.68|-18.51|0.0142
73815868|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.51|STANDARD_ERROR_OF_MEAN|4.612||0.0037|TWO_SIDED|90.0|-21.13|-5.89|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.89|-21.13|0.0037
73815869|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-14.93|STANDARD_ERROR_OF_MEAN|4.447||0.0009|TWO_SIDED|90.0|-22.27|-7.58|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-7.58|-22.27|0.0009
73815870|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.83|STANDARD_ERROR_OF_MEAN|4.484||0.3939|TWO_SIDED|90.0|-11.23|3.57|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.57|-11.23|0.3939
73815871|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.54|STANDARD_ERROR_OF_MEAN|4.595||0.0127|TWO_SIDED|90.0|3.95|19.13|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||19.13|3.95|0.0127
73815872|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|4.49||0.9425|TWO_SIDED|90.0|-7.09|7.74|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.74|-7.09|0.9425
73815873|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.08|STANDARD_ERROR_OF_MEAN|4.544||0.0155|TWO_SIDED|90.0|3.58|18.59|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||18.59|3.58|0.0155
73815874|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|4.447||0.9757|TWO_SIDED|90.0|-7.48|7.21|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.21|-7.48|0.9757
73815875|NCT00938587|147181533|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|4.484||0.9184|TWO_SIDED|90.0|-7.86|6.94|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||6.94|-7.86|0.9184
73815876|NCT00938587|147181534|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.2403|TWO_SIDED|90.0|-0.38|0.06|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.06|-0.38|0.2403
73815877|NCT00938587|147181534|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.134||0.027|TWO_SIDED|90.0|-0.52|-0.08|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.08|-0.52|0.0270
73815878|NCT00938587|147181534|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.133||0.3139|TWO_SIDED|90.0|-0.36|0.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.09|-0.36|0.3139
73815879|NCT00938587|147181534|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.134||0.0415|TWO_SIDED|90.0|-0.5|-0.05|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.05|-0.50|0.0415
73815880|NCT00938587|147181534|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.134||0.8585|TWO_SIDED|90.0|-0.2|0.25|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.25|-0.20|0.8585
73815881|NCT00938587|147181534|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.7284|TWO_SIDED|90.0|-0.28|0.18|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.18|-0.28|0.7284
73815882|NCT00938587|147181534|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.135||0.0171|TWO_SIDED|90.0|-0.55|-0.1|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.10|-0.55|0.0171
73815883|NCT00938587|147181534|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.2277|TWO_SIDED|90.0|-0.39|0.06|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.06|-0.39|0.2277
73815884|NCT00938587|147181534|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.134||0.0013|TWO_SIDED|90.0|-0.67|-0.22|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.22|-0.67|0.0013
73815885|NCT00938587|147181534|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.135||0.3908|TWO_SIDED|90.0|-0.34|0.11|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.11|-0.34|0.3908
73815886|NCT00938587|147181535|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.66|STANDARD_ERROR_OF_MEAN|7.093||0.6067|TWO_SIDED|90.0|-15.43|8.1|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.10|-15.43|0.6067
73815887|NCT00938587|147181535|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.55|STANDARD_ERROR_OF_MEAN|7.101||0.1816|TWO_SIDED|90.0|-21.32|2.23|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.23|-21.32|0.1816
73815888|NCT00938587|147181535|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.84|STANDARD_ERROR_OF_MEAN|7.029||0.6873|TWO_SIDED|90.0|-14.5|8.82|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.82|-14.50|0.6873
73815889|NCT00938587|147181535|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.72|STANDARD_ERROR_OF_MEAN|7.052||0.2188|TWO_SIDED|90.0|-20.42|2.98|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.98|-20.42|0.2188
73815890|NCT00938587|147181535|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.83|STANDARD_ERROR_OF_MEAN|7.024||0.9067|TWO_SIDED|90.0|-10.82|12.47|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||12.47|-10.82|0.9067
73815891|NCT00938587|147181535|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.02|STANDARD_ERROR_OF_MEAN|7.254||0.5803|TWO_SIDED|90.0|-16.05|8.0|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.00|-16.05|0.5803
73815892|NCT00938587|147181535|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.29|STANDARD_ERROR_OF_MEAN|7.156||0.249|TWO_SIDED|90.0|-20.16|3.57|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.57|-20.16|0.2490
73815893|NCT00938587|147181535|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.62|STANDARD_ERROR_OF_MEAN|7.178||0.1081|TWO_SIDED|90.0|-23.52|0.28|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.28|-23.52|0.1081
73815894|NCT00938587|147181535|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-15.89|STANDARD_ERROR_OF_MEAN|7.098||0.0271|TWO_SIDED|90.0|-27.66|-4.12|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-4.12|-27.66|0.0271
73815895|NCT00938587|147181535|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|7.121||0.2881|TWO_SIDED|90.0|-19.41|4.21|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.21|-19.41|0.2881
73815896|NCT00938587|147181536|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.52|STANDARD_ERROR_OF_MEAN|7.059||0.3579|TWO_SIDED|90.0|-18.23|5.19|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.19|-18.23|0.3579
73815897|NCT00938587|147181536|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.55|STANDARD_ERROR_OF_MEAN|7.046||0.2274|TWO_SIDED|90.0|-20.24|3.14|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.14|-20.24|0.2274
73815898|NCT00938587|147181536|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.15|STANDARD_ERROR_OF_MEAN|6.973||0.1482|TWO_SIDED|90.0|-21.72|1.41|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.41|-21.72|0.1482
73815899|NCT00938587|147181536|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.19|STANDARD_ERROR_OF_MEAN|6.962||0.0828|TWO_SIDED|90.0|-23.74|-0.64|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.64|-23.74|0.0828
73815900|NCT00938587|147181536|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.64|STANDARD_ERROR_OF_MEAN|6.953||0.6021|TWO_SIDED|90.0|-15.17|7.9|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.90|-15.17|0.6021
73815901|NCT00938587|147181536|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|7.213||0.7528|TWO_SIDED|90.0|-14.24|9.68|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||9.68|-14.24|0.7528
73815902|NCT00938587|147181536|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.17|STANDARD_ERROR_OF_MEAN|7.1||0.2523|TWO_SIDED|90.0|-19.94|3.6|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.60|-19.94|0.2523
73815903|NCT00938587|147181536|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.63|STANDARD_ERROR_OF_MEAN|7.118||0.1049|TWO_SIDED|90.0|-23.43|0.17|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.17|-23.43|0.1049
73815904|NCT00938587|147181536|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.53|STANDARD_ERROR_OF_MEAN|7.006||0.0138|TWO_SIDED|90.0|-29.14|-5.91|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.91|-29.14|0.0138
73815905|NCT00938587|147181536|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.36|STANDARD_ERROR_OF_MEAN|7.052||0.1873|TWO_SIDED|90.0|-21.05|2.34|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.34|-21.05|0.1873
73815906|NCT00938587|147181537|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.54|STANDARD_ERROR_OF_MEAN|5.339||0.509|TWO_SIDED|90.0|-12.4|5.32|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.32|-12.40|0.5090
73815907|NCT00938587|147181537|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.89|STANDARD_ERROR_OF_MEAN|5.354||0.0998|TWO_SIDED|90.0|-17.78|-0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.01|-17.78|0.0998
73815908|NCT00938587|147181537|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|5.282||0.8866|TWO_SIDED|90.0|-9.52|8.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.01|-9.52|0.8866
73815909|NCT00938587|147181537|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.11|STANDARD_ERROR_OF_MEAN|5.28||0.2499|TWO_SIDED|90.0|-14.88|2.66|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.66|-14.88|0.2499
73815910|NCT00938587|147181537|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.78|STANDARD_ERROR_OF_MEAN|5.283||0.5995|TWO_SIDED|90.0|-5.99|11.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||11.55|-5.99|0.5995
73815911|NCT00938587|147181537|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|5.429||0.9117|TWO_SIDED|90.0|-8.4|9.61|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||9.61|-8.40|0.9117
73815912|NCT00938587|147181537|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.91|STANDARD_ERROR_OF_MEAN|5.381||0.0684|TWO_SIDED|90.0|-18.84|-0.98|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.98|-18.84|0.0684
73815913|NCT00938587|147181537|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.49|STANDARD_ERROR_OF_MEAN|5.366||0.2292|TWO_SIDED|90.0|-15.39|2.42|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.42|-15.39|0.2292
73815914|NCT00938587|147181537|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.0|STANDARD_ERROR_OF_MEAN|5.308||0.0018|TWO_SIDED|90.0|-25.81|-8.19|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-8.19|-25.81|0.0018
73815915|NCT00938587|147181537|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.09|STANDARD_ERROR_OF_MEAN|5.337||0.1867|TWO_SIDED|90.0|-15.95|1.76|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.76|-15.95|0.1867
73815916|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|2.708||0.9624|TWO_SIDED|90.0|-4.64|4.38|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using analysis of covariance (ANCOVA) where treatment as fixed effect, baseline as the covariate.||4.38|-4.64|0.9624
73815917|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|2.65||0.9493|TWO_SIDED|90.0|-4.24|4.58|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.58|-4.24|0.9493
73815918|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.46|STANDARD_ERROR_OF_MEAN|2.738||0.21|TWO_SIDED|90.0|-1.1|8.02|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.02|-1.10|0.2100
73815919|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.76|STANDARD_ERROR_OF_MEAN|2.651||0.1602|TWO_SIDED|90.0|-0.66|8.18|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.18|-0.66|0.1602
73815920|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.59|STANDARD_ERROR_OF_MEAN|2.71||0.1892|TWO_SIDED|90.0|-0.92|8.1|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.10|-0.92|0.1892
73815921|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.74|STANDARD_ERROR_OF_MEAN|2.781||0.7899|TWO_SIDED|90.0|-3.89|5.38|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.38|-3.89|0.7899
73815922|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.96|STANDARD_ERROR_OF_MEAN|2.719||0.149|TWO_SIDED|90.0|-0.56|8.49|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.49|-0.56|0.1490
73815923|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|2.766||0.6238|TWO_SIDED|90.0|-5.97|3.24|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.24|-5.97|0.6238
73815924|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.86|STANDARD_ERROR_OF_MEAN|2.699||0.4933|TWO_SIDED|90.0|-2.64|6.35|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.35|-2.64|0.4933
73815925|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.11|STANDARD_ERROR_OF_MEAN|2.739||0.4445|TWO_SIDED|90.0|-6.67|2.46|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.46|-6.67|0.4445
73815926|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.51|STANDARD_ERROR_OF_MEAN|2.897||0.2288|TWO_SIDED|90.0|-1.31|8.34|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.34|-1.31|0.2288
73815927|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.77|STANDARD_ERROR_OF_MEAN|2.844||0.098|TWO_SIDED|90.0|0.03|9.5|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate||9.50|0.03|0.0980
73815928|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.54|STANDARD_ERROR_OF_MEAN|2.941||0.0637|TWO_SIDED|90.0|0.64|10.43|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate||10.43|0.64|0.0637
73815929|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.79|STANDARD_ERROR_OF_MEAN|2.831||0.019|TWO_SIDED|90.0|2.07|11.5|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||11.50|2.07|0.0190
73815930|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.02|STANDARD_ERROR_OF_MEAN|2.903||0.4886|TWO_SIDED|90.0|-2.81|6.86|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.86|-2.81|0.4886
73815931|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.879||0.9951|TWO_SIDED|90.0|-3.12|3.14|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.14|-3.12|0.9951
73815932|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|1.818||0.4721|TWO_SIDED|90.0|-1.71|4.34|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.34|-1.71|0.4721
73815933|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|1.879||0.6835|TWO_SIDED|90.0|-3.9|2.36|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.36|-3.90|0.6835
73815934|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|1.818||0.7701|TWO_SIDED|90.0|-2.49|3.56|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.56|-2.49|0.7701
73815935|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.78|STANDARD_ERROR_OF_MEAN|1.831||0.671|TWO_SIDED|90.0|-3.83|2.27|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.27|-3.83|0.6710
73815936|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.02|STANDARD_ERROR_OF_MEAN|2.827||0.2886|TWO_SIDED|90.0|-1.69|7.73|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.73|-1.69|0.2886
73815937|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.22|STANDARD_ERROR_OF_MEAN|2.784||0.134|TWO_SIDED|90.0|-0.42|8.86|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.86|-0.42|0.1340
73815938|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.24|STANDARD_ERROR_OF_MEAN|2.83||0.2563|TWO_SIDED|90.0|-1.48|7.95|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.95|-1.48|0.2563
73815939|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.43|STANDARD_ERROR_OF_MEAN|2.771||0.1138|TWO_SIDED|90.0|-0.18|9.05|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.05|-0.18|0.1138
73815940|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|2.793||0.9386|TWO_SIDED|90.0|-4.44|4.87|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.87|-4.44|0.9386
73815941|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|2.701||0.8814|TWO_SIDED|90.0|-4.09|4.9|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.90|-4.09|0.8814
73815942|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.98|STANDARD_ERROR_OF_MEAN|2.64||0.1363|TWO_SIDED|90.0|-0.42|8.37|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.37|-0.42|0.1363
73815943|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|2.682||0.7864|TWO_SIDED|90.0|-3.74|5.2|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.20|-3.74|0.7864
73815944|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.619||0.1048|TWO_SIDED|90.0|-0.06|8.66|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.66|-0.06|0.1048
73815945|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|2.643||0.9024|TWO_SIDED|90.0|-4.08|4.73|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.73|-4.08|0.9024
73815946|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.62|STANDARD_ERROR_OF_MEAN|3.819||0.4954|TWO_SIDED|90.0|-3.74|8.98|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.98|-3.74|0.4954
73815947|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.14|STANDARD_ERROR_OF_MEAN|3.735||0.1729|TWO_SIDED|90.0|-1.08|11.36|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||11.36|-1.08|0.1729
73815948|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.21|STANDARD_ERROR_OF_MEAN|3.82||0.565|TWO_SIDED|90.0|-4.15|8.57|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.57|-4.15|0.5650
73815949|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.73|STANDARD_ERROR_OF_MEAN|3.73||0.2087|TWO_SIDED|90.0|-1.48|10.94|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||10.94|-1.48|0.2087
73815950|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|3.771||0.9139|TWO_SIDED|90.0|-6.69|5.87|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.87|-6.69|0.9139
73815951|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.51|STANDARD_ERROR_OF_MEAN|3.371||0.6559|TWO_SIDED|90.0|-4.11|7.12|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.12|-4.11|0.6559
73815952|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.15|STANDARD_ERROR_OF_MEAN|3.315||0.7304|TWO_SIDED|90.0|-4.37|6.67|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.67|-4.37|0.7304
73815953|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.64|STANDARD_ERROR_OF_MEAN|3.369||0.1729|TWO_SIDED|90.0|-0.98|10.25|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||10.25|-0.98|0.1729
73815954|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.27|STANDARD_ERROR_OF_MEAN|3.335||0.2038|TWO_SIDED|90.0|-1.28|9.83|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.83|-1.28|0.2038
73815955|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.13|STANDARD_ERROR_OF_MEAN|3.328||0.3503|TWO_SIDED|90.0|-2.41|8.67|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.67|-2.41|0.3503
73815956|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.29|STANDARD_ERROR_OF_MEAN|2.01||0.8875|TWO_SIDED|90.0|-3.06|3.63|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.63|-3.06|0.8875
73815957|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.97|STANDARD_ERROR_OF_MEAN|1.971||0.3203|TWO_SIDED|90.0|-1.31|5.25|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.25|-1.31|0.3203
73815958|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|2.046||0.5232|TWO_SIDED|90.0|-2.09|4.72|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.72|-2.09|0.5232
73815959|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|1.971||0.1324|TWO_SIDED|90.0|-0.28|6.28|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.28|-0.28|0.1324
73815960|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.03|STANDARD_ERROR_OF_MEAN|2.024||0.6134|TWO_SIDED|90.0|-2.34|4.4|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.40|-2.34|0.6134
73815961|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.26|STANDARD_ERROR_OF_MEAN|3.387||0.5059|TWO_SIDED|90.0|-3.38|7.91|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.91|-3.38|0.5059
73815962|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.44|STANDARD_ERROR_OF_MEAN|3.329||0.3042|TWO_SIDED|90.0|-2.1|8.99|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.99|-2.10|0.3042
73815963|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.18|STANDARD_ERROR_OF_MEAN|3.39||0.3519|TWO_SIDED|90.0|-2.47|8.82|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.82|-2.47|0.3519
73815964|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.36|STANDARD_ERROR_OF_MEAN|3.342||0.1966|TWO_SIDED|90.0|-1.21|9.92|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.92|-1.21|0.1966
73815965|NCT00938587|147181538|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.91|STANDARD_ERROR_OF_MEAN|3.345||0.786|TWO_SIDED|90.0|-4.66|6.48|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.48|-4.66|0.7860
73815966|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.286||0.109|TWO_SIDED|90.0|-0.93|0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.01|-0.93|0.1090
73815967|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.282||0.0014|TWO_SIDED|90.0|-1.38|-0.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.45|-1.38|0.0014
73815968|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.284||0.0506|TWO_SIDED|90.0|-1.03|-0.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.09|-1.03|0.0506
73815969|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.28||0.0004|TWO_SIDED|90.0|-1.48|-0.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.55|-1.48|0.0004
73815970|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.281||0.7272|TWO_SIDED|90.0|-0.56|0.37|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.37|-0.56|0.7272
73815971|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.296||0.0604|TWO_SIDED|90.0|-1.05|-0.07|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.07|-1.05|0.0604
73815972|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.285||0.0003|TWO_SIDED|90.0|-1.53|-0.59|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.59|-1.53|0.0003
73815973|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.291||0.0377|TWO_SIDED|90.0|-1.09|-0.13|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.13|-1.09|0.0377
73815974|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.28||0.0001|TWO_SIDED|90.0|-1.57|-0.65|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.65|-1.57|0.0001
73815975|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.284||0.8612|TWO_SIDED|90.0|-0.52|0.42|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.42|-0.52|0.8612
73815976|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.292||0.133|TWO_SIDED|90.0|-0.04|0.93|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.93|-0.04|0.1330
73815977|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.285||0.8542|TWO_SIDED|90.0|-0.52|0.42|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.42|-0.52|0.8542
73815978|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.288||0.2339|TWO_SIDED|90.0|-0.13|0.82|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.82|-0.13|0.2339
73815979|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5927|TWO_SIDED|90.0|-0.61|0.31|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.31|-0.61|0.5927
73815980|NCT00938587|147181539|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.284||0.7304|TWO_SIDED|90.0|-0.57|0.37|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.37|-0.57|0.7304
73815981|NCT00938587|147181540|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.29||0.0956|TWO_SIDED|90.0|-0.97|-0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.01|-0.97|0.0956
73815982|NCT00938587|147181540|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.286||0.0016|TWO_SIDED|90.0|-1.4|-0.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.45|-1.40|0.0016
73815983|NCT00938587|147181540|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.287||0.0258|TWO_SIDED|90.0|-1.13|-0.17|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.17|-1.13|0.0258
73815984|NCT00938587|147181540|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.283||0.0002|TWO_SIDED|90.0|-1.56|-0.62|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.62|-1.56|0.0002
73815985|NCT00938587|147181540|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.284||0.5692||90.0|-0.63|0.31|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.31|-0.63|0.5692
73815986|NCT00938587|147181541|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.146|TWO_SIDED|90.0|-8.65|35.98|||Barnard exact test|||Day 7||35.98|-8.65|0.1460
73815987|NCT00938587|147181541|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|38.1||||0.0052|TWO_SIDED|90.0|12.25|59.46|||Barnard exact test|||Day 7||59.46|12.25|0.0052
73815988|NCT00938587|147181541|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.3||||0.5094|TWO_SIDED|90.0|-22.0|24.66|||Barnard exact test|||Day 7||24.66|-22.00|0.5094
73815989|NCT00938587|147181541|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|25.11||||0.0551|TWO_SIDED|90.0|-0.69|48.34|||Barnard exact test|||Day 7||48.34|-0.69|0.0551
73815990|NCT00938587|147181541|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-12.99||||0.9999|TWO_SIDED|90.0|-34.09|8.78|||Barnard exact test|||Day 7||8.78|-34.09|0.9999
73815991|NCT00938587|147181541|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|10.56||||0.3027|TWO_SIDED|90.0|-17.18|37.67|||Barnard-Exact test|||Day 14||37.67|-17.18|0.3027
73815992|NCT00938587|147181541|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|21.67||||0.1074|TWO_SIDED|90.0|-6.24|46.16|||Barnard-Exact test|||Day 14||46.16|-6.24|0.1074
73815993|NCT00938587|147181541|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.46||||0.234|TWO_SIDED|90.0|-10.08|43.7|||Barnard-Exact test|||Day 14||43.70|-10.08|0.2340
73815994|NCT00938587|147181541|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|28.57||||0.0442|TWO_SIDED|90.0|0.91|53.07|||Barnard-Exact test|||Day 14||53.07|0.91|0.0442
73815995|NCT00938587|147181541|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.9||||0.3813|TWO_SIDED|90.0|-19.82|32.92|||Barnard-Exact test|||Day 14||32.92|-19.82|0.3813
73815996|NCT00938587|147181542|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|9.52||||0.1017|TWO_SIDED|90.0|-3.9|27.09|||Barnard exact test|||Day 7||27.09|-3.90|0.1017
73815997|NCT00938587|147181542|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.05||||0.0218|TWO_SIDED|90.0|4.49|38.44|||Barnard exact test|||Day 7||38.44|4.49|0.0218
73815998|NCT00938587|147181542|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|9.52||||0.1082|TWO_SIDED|90.0|-3.71|27.06|||Barnard exact test|||Day 7||27.06|-3.71|0.1082
73815999|NCT00938587|147181542|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.05||||0.0166|TWO_SIDED|90.0|4.81|38.44|||Barnard exact test|||Day 7||38.44|4.81|0.0166
73816000|NCT00938587|147181542|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22||||0.4776|TWO_SIDED|90.0|-21.61|25.87|||Barnard exact test|||Day 14||25.87|-21.61|0.4776
73816001|NCT00938587|147181542|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|27.62||||0.0347|TWO_SIDED|90.0|2.53|50.78|||Barnard exact test|||Day 14||50.78|2.53|0.0347
73816002|NCT00938587|147181542|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|7.94||||0.3343|TWO_SIDED|90.0|-13.71|31.59|||Barnard exact test|||Day 14||31.59|-13.71|0.3343
73816003|NCT00938587|147181542|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|33.33||||0.0117|TWO_SIDED|90.0|8.35|55.0|||Barnard exact test|||Day 14||55.00|8.35|0.0117
73816004|NCT00938587|147181542|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.71||||0.372|TWO_SIDED|90.0|-15.86|27.04|||Barnard exact test|||Day 14||27.04|-15.86|0.3720
73816005|NCT00938587|147181543|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.263|TWO_SIDED|90.0|-8.61|20.67|||Barnard exact test|||Day 7||20.67|-8.61|0.2630
73816006|NCT00938587|147181543|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.263|TWO_SIDED|90.0|-8.61|20.67|||Barnard exact test|||Day 7||20.67|-8.61|0.2630
73816007|NCT00938587|147181543|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.2539|TWO_SIDED|90.0|-7.51|20.67|||Barnard exact test|||Day 7||20.67|-7.51|0.2539
73816008|NCT00938587|147181543|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.2539|TWO_SIDED|90.0|-7.51|20.67|||Barnard exact test|||Day 7||20.67|-7.51|0.2539
73816009|NCT00938587|147181543|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.0477|TWO_SIDED|90.0|0.23|32.92|||Barnard exact test|||Day 14||32.92|0.23|0.0477
73816010|NCT00938587|147181543|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.0442|TWO_SIDED|90.0|0.65|32.92|||Barnard exact test|||Day 14||32.92|0.65|0.0442
73816011|NCT00938587|147181546|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.5403|TWO_SIDED|90.0|-0.34|0.75|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.75|-0.34|0.5403
73816012|NCT00938587|147181546|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.8374|TWO_SIDED|90.0|-0.61|0.48|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.48|-0.61|0.8374
73816013|NCT00938587|147181546|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.329||0.4305|TWO_SIDED|90.0|-0.28|0.8|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.80|-0.28|0.4305
73816014|NCT00938587|147181546|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.325||0.9733|TWO_SIDED|90.0|-0.55|0.53|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.53|-0.55|0.9733
73816015|NCT00938587|147181546|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.325||0.8613|TWO_SIDED|90.0|-0.48|0.6|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.60|-0.48|0.8613
73816016|NCT00938587|147181546|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.341||0.5245|TWO_SIDED|90.0|-0.35|0.78|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.78|-0.35|0.5245
73816017|NCT00938587|147181546|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.334||0.8917|TWO_SIDED|90.0|-0.6|0.51|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.51|-0.60|0.8917
73816018|NCT00938587|147181546|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.339||0.1695|TWO_SIDED|90.0|-0.09|1.03|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.03|-0.09|0.1695
73816019|NCT00938587|147181546|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.329||0.5339|TWO_SIDED|90.0|-0.34|0.75|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.75|-0.34|0.5339
73816020|NCT00938587|147181546|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.332||0.452|TWO_SIDED|90.0|-0.3|0.8|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.80|-0.30|0.4520
73816021|NCT03743402|147181558|EQUIVALENCE|The null hypothesis was a point null of exactly 0 expected difference in MME/day between arms.|Mean Difference (Final Values)|-2.54||||0.58|TWO_SIDED|95.0|-10.55|5.88|||Regression, Linear||mean difference=(pain self-management)-(usual care)|A priori power calculations indicated 90% power to detect an average 24 MME/day difference between arms.||5.88|-10.55|0.58
73816022|NCT03743402|147181559|EQUIVALENCE|The null hypothesis was a point null of exactly 0 expected difference in PEG score between arms.|Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-0.51|0.52|||Regression, Linear||mean difference = (pain self-management)-(usual care)|A priori power calculations indicated 90% power to detect a 1.2-point average difference in PEG score between arms.||0.52|-0.51|0.98
73816023|NCT03743402|147181560|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in average MME/day between arms.|Mean Difference (Final Values)|1.3||||0.72|TWO_SIDED|95.0|-5.69|8.29|||Regression, Linear||mean difference=(pain self-management)-(usual care)|||8.29|-5.69|0.72
73816024|NCT03743402|147181561|EQUIVALENCE|The null hypothesis is a point null of exactly 0 difference in expected PEG score between arms.|Mean Difference (Final Values)|-0.53||||0.07|TWO_SIDED|95.0|-1.11|0.05|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.05|-1.11|0.07
73816025|NCT03743402|147181562|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|2.11||||0.8|TWO_SIDED|95.0|-13.83|18.04|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||18.04|-13.83|0.80
73816026|NCT03743402|147181563|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|4.33||||0.02|TWO_SIDED|95.0|0.56|8.09|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||8.09|0.56|0.02
73816027|NCT03743402|147181564|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PHQ-8 score between arms.|Mean Difference (Final Values)|-0.35||||0.75|TWO_SIDED|95.0|-2.53|1.82|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.82|-2.53|0.75
73816028|NCT03743402|147181565|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PHQ-8 score between arms.|Mean Difference (Final Values)|-0.5||||0.48|TWO_SIDED|95.0|-1.87|0.87|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.87|-1.87|0.48
73816029|NCT03743402|147181566|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in GAD-7 score between arms.|Mean Difference (Final Values)|-0.25||||0.64|TWO_SIDED|95.0|-1.31|0.81|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.81|-1.31|0.64
73816030|NCT03743402|147181567|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in GAD-7 score between arms.|Mean Difference (Final Values)|0.28||||0.65|TWO_SIDED|95.0|-0.94|1.51|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.51|-0.94|0.65
73816031|NCT03743402|147181568|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PGIC score between arms.|Mean Difference (Final Values)|0.61||||0.02|TWO_SIDED|95.0|0.12|1.1|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.10|0.12|0.02
73816032|NCT03743402|147181569|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PGIC score between arms.|Mean Difference (Final Values)|1.33|||<|0.01|TWO_SIDED|95.0|0.77|1.88|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.88|0.77|<0.01
73816033|NCT03743402|147181570|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in POMI score between arms.|Mean Difference (Final Values)|0.09||||0.42|TWO_SIDED|95.0|-0.13|0.31|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.31|-0.13|0.42
73816034|NCT03743402|147181571|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in POMI score between arms.|Mean Difference (Final Values)|0.13||||0.26|TWO_SIDED|95.0|-0.1|0.36|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.36|-0.10|0.26
73816035|NCT03743402|147181572|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PODS score between arms.|Mean Difference (Final Values)|1.6||||0.54|TWO_SIDED|95.0|-3.47|6.66|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||6.66|-3.47|0.54
73816036|NCT03743402|147181573|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PODS score between arms.|Mean Difference (Final Values)|0.48||||0.59|TWO_SIDED|95.0|-1.26|2.21|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||2.21|-1.26|0.59
73816037|NCT03743402|147181574|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in opioid craving score between arms.|Mean Difference (Final Values)|-0.04||||0.9|TWO_SIDED|95.0|-0.66|0.57|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.57|-0.66|0.90
73816038|NCT03743402|147181575|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|-0.35||||0.3|TWO_SIDED|95.0|-1.03|0.32|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.32|-1.03|0.30
73816039|NCT03743402|147181576|EQUIVALENCE|The null hypothesis is a point null of the relative risk of 30% reduction from baseline equal exactly to 1.|Risk Ratio (RR)|2.1||||0.2|TWO_SIDED|95.0|0.68|6.53|||Regression, Poison||relative risk = (pain self-management)/(usual care)|||6.53|0.68|0.20
73816040|NCT03743402|147181577|EQUIVALENCE|The null hypothesis is a point null of the relative risk of 30% reduction from baseline equal exactly to 1.|Risk Ratio (RR)|1.34||||0.53|TWO_SIDED|95.0|0.54|3.32|||Regression, Poison||relative risk = (pain self-management)/(usual care)|||3.32|0.54|0.53
73816041|NCT02191046|147181583|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Final Values)|4.38|STANDARD_DEVIATION|2.89|<|0.05|TWO_SIDED|95.0|3.41|5.37|||t-test, 2 sided|||compare the mean 5S-score between before and after treatment in syringe group||5.37|3.41|<0.05
73816042|NCT02191046|147181583|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Net)|0.93|STANDARD_DEVIATION|0.42|<|0.05|TWO_SIDED|95.0|0.094|1.76|||t-test, 2 sided|||compare the mean 5S-score between 2 groups at 2 weeks after treatment||1.76|0.094|<0.05
73816043|NCT02191046|147181583|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Net)|-0.47|STANDARD_DEVIATION|0.17|<|0.05|TWO_SIDED|95.0|-0.82|-0.12|||t-test, 2 sided|||satisfaction score between two groups at 2 weeks after treatment||-0.12|-0.82|<0.05
73816044|NCT02191046|147181583|NON_INFERIORITY_OR_EQUIVALENCE|power fo study = 90%|Mean Difference (Final Values)|5.66|STANDARD_DEVIATION|3.16|<|0.05|TWO_SIDED|95.0|4.62|6.69|||t-test, 2 sided|||compare the mean 5s-score between before and after treatment in squeezable bottle group||6.69|4.62|<0.05
73816045|NCT00048997|147181591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.2853|TWO_SIDED|95.0|0.84|1.38||One-sided significance level of 0.025.|Log Rank||Prophylactic cranial irradiation (PCI) is the reference arm for the hazard ratio.|This study was designed to detect a 20% relative improvement in hazard rate: null hypothesis (observation): MST (median survival time) = 23.5 mo.; alternative hypothesis (PCI): MST= 29.4 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 1007 patients (527 deaths were required for the final analysis).||1.38|0.84|0.2853
73816046|NCT00048997|147181592|SUPERIORITY|||||||0.01|||||||Z-test, 2-sided|2-sided significance level = 0.05||||||0.01
73816047|NCT00048997|147181593|SUPERIORITY|||||||0.008|||||||Z-test, 2-sided|Significance level = 0.05||||||0.008
73816048|NCT00048997|147181594|SUPERIORITY|||||||0.2|||||||Z-test, 2-sided|Significance level = 0.05||||||0.20
73816049|NCT00048997|147181595|SUPERIORITY|||||||0.14|||||||Z-test, 2-sided|Significance level = 0.05||||||0.14
73816050|NCT00048997|147181596|SUPERIORITY|||||||0.52|||||||Z-test, 2-sided|Significance level = 0.05||||||0.52
73816051|NCT00048997|147181597|SUPERIORITY|||||||0.51|||||||Z-test, 2-sided|Significance level = 0.05||||||0.51
73816052|NCT00048997|147181598|SUPERIORITY|||||||0.11|||||||Other [Z-test, 2-sided]|Significance level = 0.05||||||0.11
73816053|NCT00048997|147181599|SUPERIORITY||Odds Ratio (OR)|2.52||||0.005|TWO_SIDED|95.0|1.32|4.8|||Regression, Logistic|2-sided significance level = 0.05|Reference level = PCI arm|The development of CNS metastases was assessed using logistic regression modeling comparing presence vs. absence of brain metastases at 1 year.||4.80|1.32|0.005
73816054|NCT02697734|147181627|SUPERIORITY||Odds Ratio (OR)|43.4|||<|0.0001|TWO_SIDED|95.0|7.06|343.19|||Cochran-Mantel-Haenszel|||||343.19|7.06|<.0001
73816055|NCT02651688|147181663|SUPERIORITY|||||||0.7103|||||||Wilcoxon rank-sum test|||||||0.7103
73816056|NCT02651688|147181663|SUPERIORITY|||||||0.4529|||||||Wilcoxon rank-sum test|||||||0.4529
73816057|NCT02651688|147181664|SUPERIORITY|||||||0.9302|||||||Wilcoxon rank-sum test|||||||0.9302
73816058|NCT02651688|147181664|SUPERIORITY|||||||0.7509|||||||Wilcoxon rank-sum test|||||||0.7509
73816059|NCT02651688|147181665|SUPERIORITY|||||||0.5095|||||||Wilcoxon rank-sum test|||||||0.5095
73816060|NCT02651688|147181665|SUPERIORITY|||||||0.623|||||||Wilcoxon rank-sum test|||||||0.6230
73816061|NCT02651688|147181666|SUPERIORITY|||||||0.296|||||||Wilcoxon rank-sum test|||||||0.2960
73816062|NCT02651688|147181666|SUPERIORITY|||||||0.2723|||||||Wilcoxon rank-sum test|||||||0.2723
73816063|NCT02651688|147181667|SUPERIORITY|||||||0.0034|||||||Wilcoxon rank-sum test|||||||0.0034
73816064|NCT02651688|147181667|SUPERIORITY|||||||0.0027|||||||Wilcoxon rank-sum test|||||||0.0027
73816065|NCT02651688|147181668|SUPERIORITY|||||||0.0146|||||||Wilcoxon rank-sum test|||||||0.0146
73816066|NCT02651688|147181668|SUPERIORITY|||||||0.0018|||||||Wilcoxon rank-sum test|||||||0.0018
73816067|NCT02651688|147181669|SUPERIORITY|||||||0.1524|||||||Wilcoxon rank-sum test|||||||0.1524
73816068|NCT02651688|147181669|SUPERIORITY|||||||0.0227|||||||Wilcoxon rank-sum test|||||||0.0227
73816069|NCT02651688|147181670|SUPERIORITY|||||||0.5873|||||||Wilcoxon rank-sum test|||||||0.5873
73816070|NCT02651688|147181670|SUPERIORITY|||||||0.9509|||||||Wilcoxon rank-sum test|||||||0.9509
73816071|NCT02651688|147181671|SUPERIORITY|||||||0.4341|||||||Wilcoxon rank-sum test|||||||0.4341
73816072|NCT02651688|147181671|SUPERIORITY|||||||1|||||||Wilcoxon rank-sum test|||||||1.0000
73816073|NCT02651688|147181672|SUPERIORITY|||||||0.022|||||||Wilcoxon rank-sum test|||||||0.0220
73816074|NCT02651688|147181672|SUPERIORITY|||||||0.3677|||||||Wilcoxon rank-sum test|||||||0.3677
73816075|NCT02651688|147181673|SUPERIORITY|||||||0.9074|||||||Wilcoxon rank-sum test|||||||0.9074
73816076|NCT02651688|147181673|SUPERIORITY|||||||0.4517|||||||Wilcoxon rank-sum test|||||||0.4517
73816077|NCT02651688|147181674|SUPERIORITY|||||||0.2962|||||||Wilcoxon rank-sum test|||||||0.2962
73816078|NCT02651688|147181674|SUPERIORITY|||||||0.3261|||||||Wilcoxon rank-sum test|||||||0.3261
73816079|NCT02651688|147181675|SUPERIORITY|||||||0.045|||||||Wilcoxon rank-sum test|||||||0.0450
73816080|NCT02651688|147181675|SUPERIORITY|||||||0.2235|||||||Wilcoxon rank-sum test|||||||0.2235
73816081|NCT02651688|147181676|SUPERIORITY|||||||0.826|||||||Wilcoxon rank-sum test|||||||0.8260
73816082|NCT02651688|147181676|SUPERIORITY|||||||0.4183|||||||Wilcoxon rank-sum test|||||||0.4183
73816083|NCT02651688|147181677|SUPERIORITY|||||||0.1144|||||||Wilcoxon rank-sum test|||||||0.1144
73816084|NCT02651688|147181677|SUPERIORITY|||||||0.3263|||||||Wilcoxon rank-sum test|||||||0.3263
73816085|NCT02651688|147181678|SUPERIORITY|||||||0.1546|||||||Wilcoxon rank-sum test|||||||0.1546
73816086|NCT02651688|147181678|SUPERIORITY|||||||0.5732|||||||Wilcoxon rank-sum test|||||||0.5732
73816087|NCT02651688|147181679|SUPERIORITY|||||||0.5581|||||||Wilcoxon rank-sum test|||||||0.5581
73816088|NCT02651688|147181679|SUPERIORITY|||||||0.5833|||||||Wilcoxon rank-sum test|||||||0.5833
73816089|NCT02651688|147181680|SUPERIORITY|||||||0.0168|||||||Wilcoxon rank-sum test|||||||0.0168
73816090|NCT02651688|147181680|SUPERIORITY|||||||0.0364|||||||Wilcoxon rank-sum test|||||||0.0364
73816091|NCT02651688|147181681|SUPERIORITY|||||||0.0992|||||||Wilcoxon rank-sum test|||||||0.0992
73816092|NCT02651688|147181681|SUPERIORITY|||||||0.1333|||||||Wilcoxon rank-sum|||||||0.1333
73816093|NCT02651688|147181682|SUPERIORITY|||||||0.0139|||||||Wilcoxon rank-sum test|||||||0.0139
73816094|NCT02651688|147181682|SUPERIORITY|||||||0.0225|||||||Wilcoxon rank-sum test|||||||0.0225
73816095|NCT01693185|147181696|SUPERIORITY_OR_OTHER||||||<|0.001||||||We wished to be able to distinguish a difference of 7.5 min,|Wilcoxon (Mann-Whitney)|||Recovery time in patients administered remifentanil alone will be significantly shorter than that in patients administered midazolam-meperidine combination for colonoscopy.||||< 0.001
73816203|NCT00094536|147181793|SUPERIORITY_OR_OTHER|||||||0.271|||||||1-sided z-test|1-sided z-test with continuity correction (pooled)||||||.271
73816204|NCT01687283|147181797|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-1.8||||0.733|TWO_SIDED|95.0|-12.19|8.59||Analysis performed using ANCOVA with covariates of baseline, center, sex, age and treatment|ANCOVA||The analysis only included participants who had at least 4 days of non-missing AM PEF data in the baseline week prior to randomization and at least 4 days of non-missing AM PEF data after randomization.|||8.59|-12.19|0.733
73816205|NCT01687283|147181798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-2.28||||0.674|TWO_SIDED|95.0|-12.95|8.38|||ANCOVA|||||8.38|-12.95|0.674
73816206|NCT01687283|147181799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.77||||0.579|TWO_SIDED|95.0|-12.57|7.04|||ANCOVA|||||7.04|-12.57|0.579
73816207|NCT01687283|147181800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62||||0.854|TWO_SIDED|95.0|-6.0|7.24|||ANCOVA|||||7.24|-6.00|0.854
73816208|NCT01687283|147181801|SUPERIORITY_OR_OTHER|||||||0.123|||||||Wilcoxon rank sum test|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median day-time symptom score||||0.123
73816209|NCT01687283|147181801|SUPERIORITY_OR_OTHER|||||||0.949|||||||Wilcoxon rank sum test.|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median night-time symptom score||||0.949
73816210|NCT01687283|147181802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.74||||0.204|TWO_SIDED|95.0|-12.07|2.59|||ANCOVA|||||2.59|-12.07|0.204
73816211|NCT01687283|147181803|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon Rank sum|||||||0.170
73816212|NCT01687283|147181804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.039||||0.337|TWO_SIDED|95.0|-0.118|0.041||Repeated Measures analysis adjusted for baseline, centre, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 2||0.041|-0.118|0.337
73816213|NCT01687283|147181804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.008||||0.866|TWO_SIDED|95.0|-0.101|0.085||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 4||0.085|-0.101|0.866
73816214|NCT01687283|147181804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025||||0.566|TWO_SIDED|95.0|-0.113|0.062||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 8||0.062|-0.113|0.566
73816215|NCT01687283|147181804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017||||0.727|TWO_SIDED|95.0|-0.078|0.112||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 12||0.112|-0.078|0.727
73816216|NCT03041467|147181809|SUPERIORITY||||||<|0.001|||||||One-sided Z-test|||||||<0.001
73816217|NCT03041467|147181810|NON_INFERIORITY|Non-inferiority p-values for the primary safety endpoint was based on the Farrington-Manning non-inferiority test with a margin of 7.5%.||||||0.002|||||||Farrington-Manning Test|||||||0.002
73816218|NCT03041467|147181811|SUPERIORITY||||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|Log Rank|||Kaplan-Meier method was used to estimate access circuit primary patency.||||<0.001
73816219|NCT03041467|147181812|OTHER|There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months. Survival analysis was performed using Kaplan-Meier method.|Log Rank|||Kaplan-Meier method was used to estimate target lesion primary patency.|Survival analysis was performed using Kaplan-Meier method.|||<0.001
73816220|NCT03041467|147181813|SUPERIORITY||||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|Chi-squared|||||||<0.001
73816221|NCT03041467|147181817|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
73816222|NCT03041467|147181818|SUPERIORITY|||||||0.482|||||||Chi-squared|||||||0.482
73816223|NCT03041467|147181819|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
73816224|NCT01760447|147181911|SUPERIORITY||Least Squares Mean Difference|-0.49|||=|0.018|TWO_SIDED|95.0|-0.9|-0.09|||Mixed Models Analysis|||"The Least Squares (LS) Mean for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||-0.09|-0.90|= 0.018
73816225|NCT01760447|147181912|OTHER||Difference in Percentage|-1.3|||||TWO_SIDED|95.0|-13.9|11.3|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who experienced ≥1 adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||11.3|-13.9|
73816226|NCT01760447|147181913|OTHER||Difference in Percentage|-0.5|||||TWO_SIDED|95.0|-6.2|5.0|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||5.0|-6.2|
73816227|NCT01760447|147181914|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-8.9|14.4|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who experienced ≥1 adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||14.4|-8.9|
73816228|NCT01760447|147181915|OTHER||Difference in Percentage|-2.1|||||TWO_SIDED|95.0|-10.1|5.8|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||5.8|-10.1|
73816229|NCT01760447|147181917|SUPERIORITY||Least Squares Mean Difference|-10.8|||=|0.159|TWO_SIDED|95.0|-25.9|4.3|||Mixed Models Analysis|||"The Least Squares (LS) Mean for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||4.3|-25.9|= 0.159
73816230|NCT01760447|147181919|SUPERIORITY||Difference in Percentage|16.0||||0.017|TWO_SIDED|95.0|2.9|28.9|||Miettinen and Nurminen|||"The percentage of participants with A1C at the A1C goal (\<7.0%) in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled. For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal."||28.9|2.9|0.017
73816231|NCT01760447|147181920|SUPERIORITY||Difference in Percentage|12.2||||0.049|TWO_SIDED|95.0|0.0|24.8|||Miettinen and Nurminen|||"The percentage of participants with A1C at the A1C goal (\<6.5%) in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled. For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal."||24.8|0.0|0.049
73816232|NCT01760447|147181923|SUPERIORITY||Kaplan-Meier Difference in Percentage|-13.2||||0.002|TWO_SIDED|95.0|-21.1|-5.3|||Log-Rank Test|||"The percentage of participants initiating glycemic rescue therapy in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||-5.3|-21.1|0.002
73816233|NCT04278924|147181939|SUPERIORITY||Risk Difference (RD)|43.59|||=|0.056|TWO_SIDED|95.0|0.81|73.35|||Barnard's test||95% confidence interval (CI) of the difference in percentage was calculated using Miettinen-Nurminen method.|||73.35|0.81|=0.056
73816234|NCT04278924|147181939|SUPERIORITY||Risk Difference (RD)|39.42|||=|0.088|TWO_SIDED|95.0|-4.24|71.38|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||71.38|-4.24|=0.088
73816235|NCT04278924|147181939|SUPERIORITY||Risk Difference (RD)|67.83|||=|0.001|TWO_SIDED|95.0|29.21|87.29|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||87.29|29.21|=0.001
73816236|NCT04278924|147181940|SUPERIORITY||Risk Difference (RD)|55.56|||=|0.001|TWO_SIDED|95.0|25.11|81.51|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||81.51|25.11|=0.001
73816237|NCT04278924|147181940|SUPERIORITY||Risk Difference (RD)|50.0|||=|0.004|TWO_SIDED|95.0|19.63|78.95|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||78.95|19.63|=0.004
73816238|NCT04278924|147181940|SUPERIORITY||Risk Difference (RD)|81.82|||<|0.001|TWO_SIDED|95.0|51.24|94.99|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||94.99|51.24|<0.001
73816239|NCT04278924|147181941|SUPERIORITY||Risk Difference (RD)|35.9|||=|0.12|TWO_SIDED|95.0|-7.22|67.75|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||67.75|-7.22|=0.120
73816240|NCT04278924|147181941|SUPERIORITY||Risk Difference (RD)|44.23|||=|0.06|TWO_SIDED|95.0|-0.83|73.77|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||73.77|-0.83|=0.060
73816241|NCT04278924|147181941|SUPERIORITY||Risk Difference (RD)|60.14|||=|0.003|TWO_SIDED|95.0|21.33|82.42|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||82.42|21.33|=0.003
73816242|NCT04278924|147181942|SUPERIORITY||Risk Difference (RD)|40.0|||=|0.187|TWO_SIDED|95.0|-16.28|78.17|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||78.17|-16.28|=0.187
73816243|NCT04278924|147181942|SUPERIORITY||Risk Difference (RD)|25.0|||=|0.315|TWO_SIDED|95.0|-28.85|71.78|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||71.78|-28.85|=0.315
73816244|NCT04278924|147181942|SUPERIORITY||Risk Difference (RD)|100.0|||=|0.004|TWO_SIDED|95.0|35.12|100.0|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||100.00|35.12|=0.004
73816245|NCT04847232|147181951|OTHER|Test of HR = 1|Hazard Ratio (HR)|0.98||||0.867|TWO_SIDED|95.0|0.76|1.26|||Regression, Cox||SZC relative to Placebo|||1.26|0.76|0.867
73816246|NCT04847232|147181952|OTHER|Test of OR = 1|Odds Ratio (OR)|3.36|||<|0.0001|TWO_SIDED|95.0|2.64|4.26|||Regression, Logistic||SZC relative to Placebo|||4.26|2.64|<.0001
73816247|NCT04847232|147181953|OTHER|Test of HR = 1|Hazard Ratio (HR)|1.12||||0.51|TWO_SIDED|95.0|0.8|1.56|||Regression, Cox||SZC relative to Placebo|||1.56|0.80|0.510
73816248|NCT04348500|147181969|SUPERIORITY|||||||0.1||||||P-value was not adjusted.|Chi-squared|||The null hypothesis is that there is no difference in the use of clazakizumab as a treatment compared to placebo in reducing or eliminating the incidence of severe adverse events among patients with COVID-19.||||0.10
73816249|NCT04348500|147181975|SUPERIORITY|||||||0.1||||||P-value was not adjusted.|Fisher Exact|||Null hypothesis is that there is no change in the need for mechanical ventilation and/or ECMO at 14 days after the first administered dose in comparison to placebo.||||0.10
73816250|NCT05460078|147181982|SUPERIORITY||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|95.0|1.16|1.68|||Mixed Models Analysis|||||1.68|1.16|<0.001
73816251|NCT05460078|147181983|SUPERIORITY||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|95.0|1.18|1.65|||Mixed Models Analysis|||||1.65|1.18|<0.001
73816252|NCT05460078|147181984|SUPERIORITY||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.54|2.48|||Mixed Models Analysis|||||2.48|1.54|<0.001
73816253|NCT05460078|147181985|SUPERIORITY||Odds Ratio (OR)|1.4|||<|0.001|TWO_SIDED|95.0|1.17|1.66|||Mixed Models Analysis|||||1.66|1.17|<0.001
73816254|NCT03714776|147181991|SUPERIORITY||||||<|0.001||||||P-value of analysis of variance (ANOVA) with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||||||<0.001
73816255|NCT03714776|147181992|SUPERIORITY|||||||0.454||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 3||||0.454
73816256|NCT03714776|147181992|SUPERIORITY|||||||0.909||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 8||||0.909
73816257|NCT03714776|147181992|SUPERIORITY|||||||0.132||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 15||||0.132
73816258|NCT03714776|147181992|SUPERIORITY|||||||0.659||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 22||||0.659
73816259|NCT03714776|147181992|SUPERIORITY|||||||0.474||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 29||||0.474
73816260|NCT03714776|147181992|SUPERIORITY|||||||0.483||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 36||||0.483
73816261|NCT03714776|147181993|SUPERIORITY|||||||0.064||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 3||||0.064
73816262|NCT03714776|147181993|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 8||||<0.001
73816263|NCT03714776|147181993|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 15||||<0.001
73816264|NCT03714776|147181993|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 22||||<0.001
73816265|NCT03714776|147181993|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 29||||<0.001
73816266|NCT03714776|147181993|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 36||||<0.001
73816267|NCT03517449|147181997|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.47|0.66|||Log Rank||Regression, Cox method|||0.66|0.47|<0.0001
73816268|NCT03517449|147181998|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75|||Log Rank||Regression, Cox method|||0.75|0.51|<0.0001
73816269|NCT03517449|147181999|SUPERIORITY||Difference in Percent|17.2|||<|0.0001|TWO_SIDED|95.0|11.5|22.9|||Miettinen & Nurminen method|||||22.9|11.5|<0.0001
73816270|NCT02005627|147182011|SUPERIORITY||||||<|0.05||||||calculated|t-test, 2 sided|||||||<0.05
73816271|NCT02005627|147182014|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73816272|NCT02005627|147182015|SUPERIORITY|||||||||||||||||Null Hypothesis was no difference between Grazax and Placebo treatment at 12 months. 80% power to detect 30% difference in total nasal symptom score (TNSS) after nasal challenge|Comparison of nasal symptom score at 0-60 mins after nasal challenge after 12 months treatment with Grazax compared to Placebo treatment. Mixed model analysis. 80% power to detect a 30% difference at p\<0.05.|||
73816273|NCT00548249|147182016|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.0||||0.999|TWO_SIDED|95.0|0.3|3.32||p-value not adjusted for multiple comparisons|Log Rank|||Hazard ratio with 95% confidence intervals comparing each SFP treatment group to placebo, and p-value from cox proportional hazards model||3.32|0.30|0.999
73816274|NCT00548249|147182016|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.17||||0.807|TWO_SIDED|95.0|0.33|4.09|||Log Rank|||||4.09|0.33|0.807
73816275|NCT00548249|147182016|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.8||||0.748|TWO_SIDED|95.0|0.21|3.02|||Log Rank|||||3.02|0.21|0.748
73816276|NCT00548249|147182016|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.77||||0.299|TWO_SIDED|95.0|0.6|5.19|||Log Rank|||||5.19|0.60|0.299
73816277|NCT00548249|147182017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.234||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect.||||0.234
73816278|NCT00548249|147182017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.049
73816279|NCT00548249|147182017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.375||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.375
73816280|NCT00548249|147182017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.625
73816281|NCT03003000|147182022|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.3446|TWO_SIDED|95.0|-0.168|0.48||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeated Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline placebo. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with placebo.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix.|0.480|-0.168|0.3446
73816282|NCT03003000|147182022|SUPERIORITY||Mean Difference (Final Values)|-0.129||||0.3358|TWO_SIDED|95.0|-0.392|0.134||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline ibuprofen. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with ibuprofen.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix|0.134|-0.392|0.3358
73816283|NCT03003000|147182023|SUPERIORITY||Mean Difference (Final Values)|-0.288||||0.0474|TWO_SIDED|95.0|-0.572|-0.003||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine|||-0.003|-0.572|0.0474
73816284|NCT03003000|147182023|SUPERIORITY||Mean Difference (Final Values)|0.051||||0.6658|TWO_SIDED|95.0|-0.18|0.282||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine.|||0.282|-0.180|0.6658
73816285|NCT03003000|147182024|SUPERIORITY||Mean Difference (Final Values)|-0.399||||0.0091|TWO_SIDED|95.0|-0.698|-0.1||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine|||-0.100|-0.698|0.0091
73816286|NCT03003000|147182024|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.6387|TWO_SIDED|95.0|-0.185|0.302||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine|||0.302|-0.185|0.6387
73816287|NCT03003000|147182025|SUPERIORITY||Mean Difference (Final Values)|0.559||||0.4398|TWO_SIDED|95.0|-0.861|1.979||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect model for repeated measures||Adjusted mean change ibuprofen and caffeine - Adjusted mean change placebo. A negative result favors ibuprofen and caffeine.|Mixed effect model for repeated measures (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.||1.979|-0.861|0.4398
73816288|NCT03003000|147182025|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.7911|TWO_SIDED|95.0|-1.002|1.314||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change ibuprofen and caffeine - Adjusted mean change ibuprofen. A negative result favors ibuprofen and caffeine.|MMRM includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.||1.314|-1.002|0.7911
73816289|NCT03003000|147182026|SUPERIORITY||Odds Ratio (OR)|1.777||||0.0045|TWO_SIDED|95.0|1.195|2.642||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator|||2.642|1.195|0.0045
73816290|NCT03003000|147182026|SUPERIORITY||Odds Ratio (OR)|1.008||||0.9603|TWO_SIDED|95.0|0.732|1.389||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator|||1.389|0.732|0.9603
73816291|NCT03003000|147182027|SUPERIORITY||Odds Ratio (OR)|1.028||||0.9022|TWO_SIDED|95.0|0.663|1.592||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.592|0.663|0.9022
73816292|NCT03003000|147182027|SUPERIORITY||Odds Ratio (OR)|0.834||||0.3129|TWO_SIDED|95.0|0.586|1.187||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.187|0.586|0.3129
73816293|NCT03003000|147182027|SUPERIORITY||Odds Ratio (OR)|1.354||||0.3301|TWO_SIDED|95.0|0.736|2.494||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|2.494|0.736|0.3301
73816294|NCT03003000|147182027|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0864|TWO_SIDED|95.0|0.437|1.057||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.057|0.437|0.0864
73816295|NCT03003000|147182028|SUPERIORITY|||||||0.9384||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test||||||0.9384
73816296|NCT03003000|147182028|SUPERIORITY|||||||0.3534||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test||||||0.3534
73816297|NCT04006509|147182089|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||||||0.985
73816298|NCT04006509|147182090|SUPERIORITY|||||||0.539|||||||Marginal Two-Part Model|||||||0.539
73816299|NCT04006509|147182091|SUPERIORITY|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||||||0.959
73816300|NCT04006509|147182092|SUPERIORITY|||||||0.743|||||||Marginal Two-Part Model|||||||0.743
73816301|NCT04006509|147182093|SUPERIORITY|||||||0.886|||||||Marginalized Two-Part Model|||||||0.886
73816302|NCT04006509|147182094|SUPERIORITY|||||||0.107|||||||Marginalized Two-Part Model|||||||0.107
73816303|NCT04006509|147182095|SUPERIORITY|||||||0.687|||||||Marginalized Two-Part Model|||||||0.687
73816304|NCT04006509|147182096|SUPERIORITY|||||||0.871|||||||Marginalized Two-Part Model|||||||0.871
73816305|NCT04006509|147182097|SUPERIORITY|||||||0.376|||||||Marginalized Two-Part Model|||||||0.376
73816306|NCT04006509|147182098|SUPERIORITY|||||||0.77|||||||Marginalized Two-Part Model|||||||0.770
73816307|NCT04006509|147182099|SUPERIORITY|||||||0.237|||||||Marginalized Two-Part Model|||||||0.237
73816308|NCT02759835|147182112|OTHER|||||||0.56|||||||Kaplan-Meier|||||||0.56
73816309|NCT02759835|147182114|OTHER|||||||0.4|||||||Kaplan-Meier|||||||0.40
73816310|NCT02007278|147182126|NON_INFERIORITY_OR_EQUIVALENCE|Power=95%; significance level=5%, characteristic operation curves were used with a non-central F distribution for the calculation of the sample size||||||0.451|||||||Wilcoxon (Mann-Whitney)|||||||0.4510
73816311|NCT00002525|147182134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178||||||one-sided log-rank test p value|Log Rank|||||||0.178
73816312|NCT00002525|147182135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.847||||||two-sided log rank test|Log Rank|||||||0.847
73816313|NCT03230838|147182145|OTHER|The Miettinen \& Nurminen method was used.|Percentage Difference|-1.6|||||TWO_SIDED|95.0|-19.7|17.9|||||Ceftolozane/Tazobactam (C/T) minus Meropenem (Mero)|Difference in Percentage (C/T minus Mero)||17.9|-19.7|
73816314|NCT03230838|147182146|OTHER|The Miettinen \& Nurminen method was used.|Percentage Difference|1.0|||||TWO_SIDED|95.0|-9.5|5.5|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||5.5|-9.5|
73816315|NCT03230838|147182147|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-7.3|||||TWO_SIDED|95.0|-17.99|10.05|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||10.05|-17.99|
73816316|NCT03230838|147182148|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-5.6|||||TWO_SIDED|95.0|-14.09|8.88|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||8.88|-14.09|
73816317|NCT03230838|147182149|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-3.0|||||TWO_SIDED|95.0|-17.13|17.4|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||17.40|-17.13|
73816318|NCT03230838|147182150|OTHER|The Miettinen \& Nurminen method stratified by age group with CMH weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-3.4|||||TWO_SIDED|95.0|-12.67|13.41|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||13.41|-12.67|
73816319|NCT04475718|147182151|OTHER|Preliminary Efficacy|||||<|0.001|||||||t-test, 2 sided|||||||<.001
73816320|NCT01505179|147182156|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
73816321|NCT01505179|147182157|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
73816322|NCT01505179|147182158|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.74
73816323|NCT01505179|147182159|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
73816324|NCT00435188|147182163|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Omnibus p value for group difference between groups at the end of the study and group by time interaction|Mixed Models Analysis|||||||<0.001
73816325|NCT00435188|147182166|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value reporting overall differences between groups for group and group by time interaction with two degrees of freedom||||0.47
73816326|NCT00435188|147182169|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value for overall difference between groups at the end of the study and group by time interaction on two degrees of freedom||||0.04
73816327|NCT00435188|147182170|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value provides the overall differences between groups at the end of the study||||<0.001
73816328|NCT00435188|147182173|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value provides the overall difference between groups at the end of the study||||0.29
73816329|NCT00435188|147182176|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Mixed Models Analysis|||P value provides overall differences between groups at the end of the study||||0.35
73816330|NCT00435188|147182179|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||P value provides the overall differences between groups at the end of the study||||0.08
73816331|NCT00497055|147182186|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.41||95.0|0.66|1.16|||Generalized estimating equation|||||1.16|.66|.41
73816332|NCT00497055|147182187|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
73816333|NCT00497055|147182188|SUPERIORITY_OR_OTHER||||||>=|0.99|||||||Fisher Exact|||||||>=0.99
73816334|NCT00055497|147182209|SUPERIORITY_OR_OTHER|||||||0.142|||||||Log Rank|||||||0.142
73816335|NCT00055497|147182210|SUPERIORITY_OR_OTHER|||||||0.029|||||||Fisher Exact|||||||0.029
73816336|NCT00055497|147182211|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||Week 24||||0.330
73816337|NCT00055497|147182211|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||Week 24||||0.001
73816338|NCT00055497|147182211|SUPERIORITY_OR_OTHER|||||||0.508|||||||Fisher Exact|||Week 56||||0.508
73816339|NCT00055497|147182211|SUPERIORITY_OR_OTHER|||||||0.044|||||||Fisher Exact|||Week 56||||0.044
73816340|NCT00055497|147182212|SUPERIORITY_OR_OTHER|||||||0.191|||||||Fisher Exact|||Week 24||||0.191
73816341|NCT00055497|147182212|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||Week 24||||0.003
73816342|NCT00055497|147182212|SUPERIORITY_OR_OTHER|||||||0.508|||||||Fisher Exact|||Week 56||||0.508
73816343|NCT00055497|147182212|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||Week 56||||0.004
73816344|NCT00055497|147182213|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
73816345|NCT00048165|147182218|SUPERIORITY_OR_OTHER||percent mean difference|-12.0||||0.007|TWO_SIDED|95.0|-20.9|-3.3|||Cochran-Mantel-Haenszel|||||-3.3|-20.9|0.007
73816346|NCT00048165|147182219|SUPERIORITY_OR_OTHER||percent mean difference|-8.6||||0.063|TWO_SIDED|95.0|-17.7|0.5|||Cochran-Mantel-Haenszel|||||0.5|-17.7|0.063
73816347|NCT00048165|147182222|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 6 months were presented||||0.0005
73816348|NCT00048165|147182222|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 12 months were presented||||0.0008
73816349|NCT02503254|147182248|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|82.82|||<|0.001|TWO_SIDED|95.0|78.79|86.09||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."||86.09|78.79|<.001
73816350|NCT02503254|147182249|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|63.53|||<|0.001|TWO_SIDED|95.0|59.55|67.12||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively"||67.12|59.55|<0.001
73816351|NCT02503254|147182250|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|88.14|||<|0.001|TWO_SIDED|95.0|86.46|89.62||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."||89.62|86.46|<.001
73816352|NCT02503254|147182251|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|58.83|||<|0.001|TWO_SIDED|95.0|49.3|66.56||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC respectively."||66.56|49.30|<.001
73816353|NCT00073008|147182257|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|34.5||||||95.0|13.7|55.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||55.4|13.7|
73816354|NCT00073008|147182257|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|19.7||||||95.0|2.9|36.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||36.4|2.9|
73816355|NCT00073008|147182258|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|27.1||||||95.0|11.9|42.3|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||42.3|11.9|
73816356|NCT00073008|147182258|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|18.3||||||95.0|3.9|32.6|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||32.6|3.9|
73816357|NCT01156051|147182314|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.005
73816358|NCT01156051|147182315|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Null hypothesis: no difference in ADHD Rating Scales - IV total scores from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||<0.001
73816359|NCT01156051|147182316|SUPERIORITY_OR_OTHER|||||||0.392|||||||ANOVA|||Null hypothesis: no difference in latency to persistent sleep (LPS) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.392
73816360|NCT01156051|147182317|SUPERIORITY_OR_OTHER|||||||0.059|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.059
73816361|NCT02227368|147182340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.3441|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.|||0.1|-0.4|0.3441
73816362|NCT02227368|147182341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.6186|TWO_SIDED|95.0|-0.4|0.6|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.|||0.6|-0.4|0.6186
73816363|NCT01160380|147182346|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment||||0.289
73816364|NCT01160380|147182346|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and Day 28||||<0.001
73816365|NCT01160380|147182346|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and day 28||||<0.002
73816366|NCT01160380|147182346|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the armodafinil arm||||0.449
73816367|NCT01160380|147182347|SUPERIORITY_OR_OTHER|||||||0.954|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment||||0.954
73816368|NCT01160380|147182347|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm||||0.007
73816369|NCT01160380|147182347|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm||||0.369
73816370|NCT01160380|147182347|SUPERIORITY_OR_OTHER|||||||0.973|TWO_SIDED||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the Armodafinil arm||||0.973
73816371|NCT01160380|147182348|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms at day 28||||0.699
73816372|NCT01160380|147182348|SUPERIORITY_OR_OTHER|||||||0.984|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm||||0.984
73816373|NCT01160380|147182348|SUPERIORITY_OR_OTHER|||||||0.239|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm||||0.239
73816374|NCT01160380|147182348|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm||||0.089
73816375|NCT01160380|147182349|SUPERIORITY_OR_OTHER|||||||0.636|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Forward test||||0.636
73816376|NCT01160380|147182349|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Backward test||||0.531
73816377|NCT01160380|147182349|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Forward test||||0.037
73816378|NCT01160380|147182349|SUPERIORITY_OR_OTHER|||||||0.656|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Backward test||||0.656
73816379|NCT01160380|147182349|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Forward test||||0.028
73816380|NCT01160380|147182349|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Backward test||||0.805
73816381|NCT01160380|147182349|SUPERIORITY_OR_OTHER|||||||0.692|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Forward test||||0.692
73816382|NCT01160380|147182349|SUPERIORITY_OR_OTHER|||||||0.863|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Backward test||||0.863
73816383|NCT01160380|147182350|SUPERIORITY_OR_OTHER|||||||0.559|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for Day 28 of treatment- FACIT-F total||||0.559
73816384|NCT01160380|147182350|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm- FACIT-F total||||<0.001
73816385|NCT01160380|147182350|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Armodafinil arm- FACIT-F total||||0.192
73816386|NCT01160380|147182350|SUPERIORITY_OR_OTHER|||||||0.495|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56of treatment for the Armodafinil arm- FACIT-F total||||0.495
73816387|NCT01160380|147182351|SUPERIORITY_OR_OTHER|||||||0.945|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS anxiety||||0.945
73816388|NCT01160380|147182351|SUPERIORITY_OR_OTHER|||||||0.316|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS depression||||0.316
73816389|NCT01160380|147182351|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS anxiety||||0.005
73816390|NCT01160380|147182351|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression||||0.005
73816391|NCT01160380|147182351|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm-HADS anxiety||||0.001
73816392|NCT01160380|147182351|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression||||0.315
73816393|NCT01160380|147182351|SUPERIORITY_OR_OTHER|||||||0.933|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS anxiety||||0.933
73816394|NCT01160380|147182351|SUPERIORITY_OR_OTHER|||||||0.378|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS depression||||0.378
73816395|NCT01160380|147182352|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for Day 28 of treatment -ESS||||0.840
73816396|NCT01160380|147182352|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-ESS||||0.050
73816397|NCT01160380|147182352|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 and Day 28 of treatment for the Armodafinil arm- ESS||||0.051
73816398|NCT01160380|147182352|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm||||0.635
73816399|NCT03046056|147182370|SUPERIORITY||Risk Difference in Proportions|8.3|||||TWO_SIDED|90.0|-16.5|32.1||||||||32.1|-16.5|
73816400|NCT03046056|147182370|SUPERIORITY||Risk Difference in Proportions|8.3|||||TWO_SIDED|90.0|-15.9|32.0||||||||32.0|-15.9|
73816401|NCT03046056|147182371|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|90.0|-5.3|0.7||||||Difference in least squared means (Diff in LSM), and its 90% confidence interval (CI) were from analysis of covariance (ANCOVA) model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||0.7|-5.3|
73816402|NCT03046056|147182371|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|90.0|-2.7|3.1||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||3.1|-2.7|
73816403|NCT03046056|147182372|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-3.9|0.7||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||0.7|-3.9|
73816404|NCT03046056|147182372|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-3.2|1.2||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||1.2|-3.2|
73816405|NCT03046056|147182373|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|90.0|-2.2|2.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||2.0|-2.2|
73816406|NCT03046056|147182373|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.9|2.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||2.0|-1.9|
73816407|NCT03046056|147182374|SUPERIORITY||Risk Difference in Proportions|-1.7|||||TWO_SIDED|90.0|-28.6|25.5||||||||25.5|-28.6|
73816408|NCT03046056|147182374|SUPERIORITY||Risk Difference in Proportions|0.4|||||TWO_SIDED|90.0|-24.5|26.2||||||||26.2|-24.5|
73816409|NCT03046056|147182375|SUPERIORITY||Risk Difference in Proportions|-6.7|||||TWO_SIDED|90.0|-47.3|37.0||||||||37.0|-47.3|
73816410|NCT03046056|147182375|SUPERIORITY||Risk Difference in Proportions|-16.7|||||TWO_SIDED|90.0|-58.2|30.0||||||||30.0|-58.2|
73816411|NCT03046056|147182376|SUPERIORITY||Risk Difference in Proportions|33.3|||||TWO_SIDED|90.0|-32.4|86.5||||||||86.5|-32.4|
73816412|NCT03046056|147182377|SUPERIORITY||Risk Difference in Proportions|-2.3|||||TWO_SIDED|90.0|-28.6|24.3||||||||24.3|-28.6|
73816413|NCT03046056|147182377|SUPERIORITY||Risk Difference in Proportions|-15.0|||||TWO_SIDED|90.0|-39.4|11.3||||||||11.3|-39.4|
73816414|NCT03046056|147182378|SUPERIORITY||Risk Difference in Proportions|3.3|||||TWO_SIDED|90.0|-38.9|45.7||||||||45.7|-38.9|
73816415|NCT03046056|147182378|SUPERIORITY||Risk Difference in Proportions|-4.2|||||TWO_SIDED|90.0|-47.5|40.8||||||||40.8|-47.5|
73816416|NCT03046056|147182379|SUPERIORITY||Risk Difference in Proportions|50.0|||||TWO_SIDED|90.0|-16.8|89.5||||||||89.5|-16.8|
73816417|NCT03046056|147182379|SUPERIORITY||Risk Difference in Proportions|12.5|||||TWO_SIDED|90.0|-46.1|63.3||||||||63.3|-46.1|
73816418|NCT03046056|147182380|SUPERIORITY||Risk Difference in Proportions|8.0|||||TWO_SIDED|90.0|-17.2|32.6||||||||32.6|-17.2|
73816419|NCT03046056|147182380|SUPERIORITY||Risk Difference in Proportions|6.3|||||TWO_SIDED|90.0|-18.1|30.2||||||||30.2|-18.1|
73816420|NCT03046056|147182381|SUPERIORITY||Risk Difference in Proportions|3.3|||||TWO_SIDED|90.0|-22.1|28.1||||||||28.1|-22.1|
73816421|NCT03046056|147182381|SUPERIORITY||Risk Difference in Proportions|-4.2|||||TWO_SIDED|90.0|-28.1|20.3||||||||20.3|-28.1|
73816422|NCT03046056|147182382|SUPERIORITY||Risk Difference in Proportions|17.1|||||TWO_SIDED|90.0|-7.6|40.4||||||||40.4|-7.6|
73816423|NCT03046056|147182382|SUPERIORITY||Risk Difference in Proportions|2.8|||||TWO_SIDED|90.0|-21.2|26.5||||||||26.5|-21.2|
73816424|NCT03046056|147182383|SUPERIORITY||Least Squares Mean Difference|-48.0|STANDARD_ERROR_OF_MEAN|28.1|||TWO_SIDED|90.0|-95.0|-1.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||-1|-95|
73816425|NCT03046056|147182383|SUPERIORITY||Least Squares Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|27.4|||TWO_SIDED|90.0|-76.0|15.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||15|-76|
73816426|NCT03046056|147182384|SUPERIORITY||Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|28.7|||TWO_SIDED|90.0|-68.0|28.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||28|-68|
73816427|NCT03046056|147182384|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|28.0|||TWO_SIDED|90.0|-52.0|42.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||42|-52|
73816428|NCT02913105|147182386|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (Body Mass Index (BMI) group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.7489|TWO_SIDED|90.0|0.83|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||||1.13|0.83|0.7489
73816429|NCT02913105|147182386|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.72||||0.0005|TWO_SIDED|90.0|0.62|0.84|||ANCOVA|An unstructured variance-covariance structure was used.||||0.84|0.62|0.0005
73816430|NCT02913105|147182386|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.74||||0.0005|TWO_SIDED|90.0|0.65|0.85|||ANCOVA|An unstructured variance-covariance structure was used.||||0.85|0.65|0.0005
73816431|NCT02913105|147182391|OTHER|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.95||||0.5354|TWO_SIDED|90.0|0.83|1.09|||ANCOVA|||||1.09|0.83|0.5354
73816432|NCT02913105|147182391|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.68|||<|0.0001|TWO_SIDED|90.0|0.59|0.78|||ANCOVA|||||0.78|0.59|<.0001
73816433|NCT02913105|147182391|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.71|||<|0.0001|TWO_SIDED|90.0|0.63|0.8|||ANCOVA|||||0.80|0.63|<.0001
73816434|NCT02913105|147182392|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.389||0.8402|TWO_SIDED|90.0|-0.724|0.567|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.567|-0.724|0.8402
73816435|NCT02913105|147182392|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.144|STANDARD_ERROR_OF_MEAN|0.472||0.7607|TWO_SIDED|90.0|-0.927|0.639|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.639|-0.927|0.7607
73816436|NCT02913105|147182392|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.228|STANDARD_ERROR_OF_MEAN|0.487||0.6406|TWO_SIDED|90.0|-1.037|0.581|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.581|-1.037|0.6406
73816437|NCT02913105|147182392|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.685||0.8185|TWO_SIDED|90.0|-1.294|0.979|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.979|-1.294|0.8185
73816438|NCT02913105|147182392|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.766||0.7804|TWO_SIDED|90.0|-1.485|1.057|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||1.057|-1.485|0.7804
73816439|NCT02913105|147182392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.598|STANDARD_ERROR_OF_MEAN|0.402||0.1403|TWO_SIDED|90.0|-1.265|0.07|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.070|-1.265|0.1403
73816440|NCT02913105|147182392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.49||0.0603|TWO_SIDED|90.0|-1.743|-0.117|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.117|-1.743|0.0603
73816441|NCT02913105|147182392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.344|STANDARD_ERROR_OF_MEAN|0.505||0.009|TWO_SIDED|90.0|-2.182|-0.506|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.506|-2.182|0.0090
73816442|NCT02913105|147182392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.787|STANDARD_ERROR_OF_MEAN|0.71||0.0134|TWO_SIDED|90.0|-2.965|-0.609|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.609|-2.965|0.0134
73816443|NCT02913105|147182392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-2.123|STANDARD_ERROR_OF_MEAN|0.793||0.0087|TWO_SIDED|90.0|-3.439|-0.807|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.807|-3.439|0.0087
73816444|NCT02913105|147182392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.519|STANDARD_ERROR_OF_MEAN|0.368||0.1609|TWO_SIDED|90.0|-1.13|0.091|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.091|-1.130|0.1609
73816445|NCT02913105|147182392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.444||0.0797|TWO_SIDED|90.0|-1.524|-0.049|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.049|-1.524|0.0797
73816446|NCT02913105|147182392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.116|STANDARD_ERROR_OF_MEAN|0.455||0.0159|TWO_SIDED|90.0|-1.872|-0.36|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.360|-1.872|0.0159
73816447|NCT02913105|147182392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.63|STANDARD_ERROR_OF_MEAN|0.635||0.0118|TWO_SIDED|90.0|-2.684|-0.575|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.575|-2.684|0.0118
73816448|NCT02913105|147182392|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.909|STANDARD_ERROR_OF_MEAN|0.7||0.0076|TWO_SIDED|90.0|-3.072|-0.746|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.746|-3.072|0.0076
73816449|NCT02913105|147182393|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.137||0.8127|TWO_SIDED|90.0|-0.26|0.195|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.195|-0.260|0.8127
73816450|NCT02913105|147182393|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.166||0.8901|TWO_SIDED|90.0|-0.298|0.252|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.252|-0.298|0.8901
73816451|NCT02913105|147182393|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.088|STANDARD_ERROR_OF_MEAN|0.177||0.6209|TWO_SIDED|90.0|-0.381|0.205|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.205|-0.381|0.6209
73816452|NCT02913105|147182393|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.238||0.8398|TWO_SIDED|90.0|-0.444|0.347|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.347|-0.444|0.8398
73816453|NCT02913105|147182393|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.266||0.7839|TWO_SIDED|90.0|-0.515|0.369|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.369|-0.515|0.7839
73816454|NCT02913105|147182393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.241|STANDARD_ERROR_OF_MEAN|0.141||0.0911|TWO_SIDED|90.0|-0.476|-0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||-0.006|-0.476|0.0911
73816455|NCT02913105|147182393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.338|STANDARD_ERROR_OF_MEAN|0.172||0.052|TWO_SIDED|90.0|-0.623|-0.053|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.053|-0.623|0.0520
73816456|NCT02913105|147182393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.183||0.0085|TWO_SIDED|90.0|-0.793|-0.187|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.187|-0.793|0.0085
73816457|NCT02913105|147182393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.657|STANDARD_ERROR_OF_MEAN|0.247||0.0091|TWO_SIDED|90.0|-1.067|-0.247|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.247|-1.067|0.0091
73816458|NCT02913105|147182393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.759|STANDARD_ERROR_OF_MEAN|0.275||0.007|TWO_SIDED|90.0|-1.216|-0.302|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.302|-1.216|0.0070
73816459|NCT02913105|147182393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.208|STANDARD_ERROR_OF_MEAN|0.129||0.1092|TWO_SIDED|90.0|-0.423|0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.006|-0.423|0.1092
73816460|NCT02913105|147182393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.315|STANDARD_ERROR_OF_MEAN|0.156||0.0457|TWO_SIDED|90.0|-0.574|-0.056|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.056|-0.574|0.0457
73816461|NCT02913105|147182393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.165||0.0162|TWO_SIDED|90.0|-0.676|-0.129|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.129|-0.676|0.0162
73816462|NCT02913105|147182393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.608|STANDARD_ERROR_OF_MEAN|0.221||0.007|TWO_SIDED|90.0|-0.975|-0.242|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.242|-0.975|0.0070
73816463|NCT02913105|147182393|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.686|STANDARD_ERROR_OF_MEAN|0.244||0.006|TWO_SIDED|90.0|-1.091|-0.281|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.281|-1.091|0.0060
73816464|NCT02913105|147182394|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.009||0.9927|TWO_SIDED|90.0|-0.015|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.014|-0.015|0.9927
73816465|NCT02913105|147182394|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.2794|TWO_SIDED|90.0|-0.007|0.035|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.035|-0.007|0.2794
73816466|NCT02913105|147182394|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.007||0.9032|TWO_SIDED|90.0|-0.012|0.013|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.013|-0.012|0.9032
73816467|NCT02913105|147182394|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.011||0.4163|TWO_SIDED|90.0|-0.009|0.027|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.027|-0.009|0.4163
73816468|NCT02913105|147182394|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.011||0.7001|TWO_SIDED|90.0|-0.022|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.014|-0.022|0.7001
73816469|NCT02913105|147182394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.009||0.5367|TWO_SIDED|90.0|-0.009|0.021|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.021|-0.009|0.5367
73816470|NCT02913105|147182394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5496|TWO_SIDED|90.0|-0.014|0.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.030|-0.014|0.5496
73816471|NCT02913105|147182394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.008||0.6844|TWO_SIDED|90.0|-0.01|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.016|-0.010|0.6844
73816472|NCT02913105|147182394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.011||0.5695|TWO_SIDED|90.0|-0.025|0.012|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.012|-0.025|0.5695
73816473|NCT02913105|147182394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.011||0.8015|TWO_SIDED|90.0|-0.021|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.016|-0.021|0.8015
73816474|NCT02913105|147182394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.008||0.4923|TWO_SIDED|90.0|-0.008|0.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.020|-0.008|0.4923
73816475|NCT02913105|147182394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.012||0.62|TWO_SIDED|90.0|-0.025|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.014|-0.025|0.6200
73816476|NCT02913105|147182394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.007||0.7423|TWO_SIDED|90.0|-0.009|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.014|-0.009|0.7423
73816477|NCT02913105|147182394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.01||0.1272|TWO_SIDED|90.0|-0.032|0.001|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.001|-0.032|0.1272
73816478|NCT02913105|147182394|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.01||0.8883|TWO_SIDED|90.0|-0.015|0.017|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.017|-0.015|0.8883
73816479|NCT02913105|147182395|OTHER|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|1.01||||0.9514|TWO_SIDED|90.0|0.84|1.21|||ANCOVA|||||1.21|0.84|0.9514
73816480|NCT02913105|147182395|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.5168|TWO_SIDED|90.0|0.78|1.12|||ANCOVA|||||1.12|0.78|0.5168
73816481|NCT02913105|147182395|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.374|TWO_SIDED|90.0|0.8|1.07|||ANCOVA|||||1.07|0.80|0.3740
73816482|NCT02913105|147182396|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9453|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.9453
73816483|NCT02913105|147182396|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.4344|TWO_SIDED|90.0|0.96|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.01|0.96|0.4344
73816484|NCT02913105|147182396|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.639|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.6390
73816485|NCT02913105|147182396|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.6329|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.02|0.97|0.6329
73816486|NCT02913105|147182396|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.664|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.6640
73816487|NCT02913105|147182396|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.7517|TWO_SIDED|90.0|0.98|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.03|0.98|0.7517
73816488|NCT02913105|147182397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.739|TWO_SIDED|90.0|0.77|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.19|0.77|0.7390
73816489|NCT02913105|147182397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.3086|TWO_SIDED|90.0|0.72|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.08|0.72|0.3086
73816490|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.288|TWO_SIDED|90.0|0.69|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.08|0.69|0.2880
73816491|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.4446|TWO_SIDED|90.0|0.73|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.12|0.73|0.4446
73816492|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.4127|TWO_SIDED|90.0|0.73|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.11|0.73|0.4127
73816493|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.8074|TWO_SIDED|90.0|0.85|1.25|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.25|0.85|0.8074
73816494|NCT02913105|147182397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6935|TWO_SIDED|90.0|0.88|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.08|0.88|0.6935
73816495|NCT02913105|147182397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.9145|TWO_SIDED|90.0|0.9|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.09|0.90|0.9145
73816496|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.9131|TWO_SIDED|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.12|0.91|0.9131
73816497|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9988|TWO_SIDED|90.0|0.91|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.10|0.91|0.9988
73816498|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.5873|TWO_SIDED|90.0|0.94|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.13|0.94|0.5873
73816499|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.905|TWO_SIDED|90.0|0.92|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.10|0.92|0.9050
73816500|NCT02913105|147182397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.1458|TWO_SIDED|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.11|0.99|0.1458
73816501|NCT02913105|147182397|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.2048|TWO_SIDED|90.0|0.98|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.12|0.98|0.2048
73816502|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.1051|TWO_SIDED|90.0|1.0|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.12|1.00|0.1051
73816503|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.0717|TWO_SIDED|90.0|1.01|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.15|1.01|0.0717
73816504|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.8083|TWO_SIDED|90.0|0.96|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.06|0.96|0.8083
73816505|NCT02913105|147182397|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.5361|TWO_SIDED|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.09|0.96|0.5361
73816506|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.0858|TWO_SIDED|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.00|0.92|0.0858
73816507|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.0096|TWO_SIDED|90.0|0.88|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||0.97|0.88|0.0096
73816508|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.0284|TWO_SIDED|90.0|0.88|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||0.98|0.88|0.0284
73816509|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.133|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.01|0.89|0.1330
73816510|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.2032|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.01|0.89|0.2032
73816511|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1141|TWO_SIDED|90.0|0.87|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.00|0.87|0.1141
73816512|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1342|TWO_SIDED|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.01|0.88|0.1342
73816513|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.0771|TWO_SIDED|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.00|0.92|0.0771
73816514|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.151|TWO_SIDED|90.0|0.91|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||1.01|0.91|0.1510
73816515|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.0744|TWO_SIDED|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||1.00|0.89|0.0744
73816516|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.8365|TWO_SIDED|90.0|0.93|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.06|0.93|0.8365
73816517|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6091|TWO_SIDED|90.0|0.92|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.05|0.92|0.6091
73816518|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.3621|TWO_SIDED|90.0|0.9|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.03|0.90|0.3621
73816519|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.5031|TWO_SIDED|90.0|0.91|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.04|0.91|0.5031
73816520|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9244|TWO_SIDED|90.0|0.96|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.04|0.96|0.9244
73816521|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.236|TWO_SIDED|90.0|0.99|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||1.08|0.99|0.2360
73816522|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.699|TWO_SIDED|90.0|0.96|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||1.07|0.96|0.6990
73816523|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.159|TWO_SIDED|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.11|0.99|0.1590
73816524|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.4256|TWO_SIDED|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.09|0.97|0.4256
73816525|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.4901|TWO_SIDED|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.09|0.96|0.4901
73816526|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.3648|TWO_SIDED|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.09|0.97|0.3648
73816527|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.8891|TWO_SIDED|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||1.12|0.91|0.8891
73896504|NCT00913458|147326246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.0551|TWO_SIDED|95.0|1.0|7.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.8|1.0|0.0551
73816528|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.4817|TWO_SIDED|90.0|0.85|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||1.07|0.85|0.4817
73816529|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.6022|TWO_SIDED|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.09|0.84|0.6022
73816530|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.447|TWO_SIDED|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.07|0.83|0.4470
73816531|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.4342|TWO_SIDED|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.07|0.83|0.4342
73816532|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85||||0.0891|TWO_SIDED|90.0|0.73|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||0.99|0.73|0.0891
73816533|NCT02913105|147182398|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.226|TWO_SIDED|90.0|0.77|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.04|0.77|0.2260
73816534|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.87||||0.0324|TWO_SIDED|90.0|0.78|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||0.97|0.78|0.0324
73816535|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85||||0.0291|TWO_SIDED|90.0|0.76|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||0.96|0.76|0.0291
73816536|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.5755|TWO_SIDED|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.09|0.84|0.5755
73816537|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.307|TWO_SIDED|90.0|0.8|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.05|0.80|0.3070
73816538|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7752|TWO_SIDED|90.0|0.86|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.12|0.86|0.7752
73816539|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.1803|TWO_SIDED|90.0|0.75|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||1.03|0.75|0.1803
73896505|NCT00913458|147326246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.2141|TWO_SIDED|95.0|0.7|4.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.8|0.7|0.2141
73816540|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.2414|TWO_SIDED|90.0|0.76|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.05|0.76|0.2414
73816541|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.0179|TWO_SIDED|90.0|0.77|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||0.95|0.77|0.0179
73816542|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.1125|TWO_SIDED|90.0|0.8|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||1.00|0.80|0.1125
73816543|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9572|TWO_SIDED|90.0|0.88|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.12|0.88|0.9572
73816544|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7372|TWO_SIDED|90.0|0.87|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.10|0.87|0.7372
73816545|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.6015|TWO_SIDED|90.0|0.92|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.17|0.92|0.6015
73816546|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.7261|TWO_SIDED|90.0|0.89|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||1.19|0.89|0.7261
73816547|NCT02913105|147182398|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9892|TWO_SIDED|90.0|0.87|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.15|0.87|0.9892
73816548|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0005|TWO_SIDED|90.0|0.87|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.95|0.87|0.0005
73816549|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.0005|TWO_SIDED|90.0|0.84|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||0.94|0.84|0.0005
73816550|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0062|TWO_SIDED|90.0|0.86|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.96|0.86|0.0062
73816551|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1214|TWO_SIDED|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||1.00|0.89|0.1214
73896506|NCT00913458|147326248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9652|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.4|-0.5|0.9652
73816552|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.0043|TWO_SIDED|90.0|0.84|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.95|0.84|0.0043
73816553|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.2615|TWO_SIDED|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||1.02|0.89|0.2615
73816554|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1331|TWO_SIDED|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.01|0.88|0.1331
73816555|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85|||<|0.0001|TWO_SIDED|90.0|0.81|0.89|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.89|0.81|<.0001
73816556|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.0001|TWO_SIDED|90.0|0.83|0.93|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||0.93|0.83|0.0001
73816557|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.83|||<|0.0001|TWO_SIDED|90.0|0.79|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.88|0.79|<.0001
73816558|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.0002|TWO_SIDED|90.0|0.81|0.92|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||0.92|0.81|0.0002
73816559|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.82|||<|0.0001|TWO_SIDED|90.0|0.77|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.88|0.77|<.0001
73816560|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.84||||0.0002|TWO_SIDED|90.0|0.78|0.9|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||0.90|0.78|0.0002
73816561|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.228|TWO_SIDED|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.02|0.89|0.2280
73816562|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.009|TWO_SIDED|90.0|0.89|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.97|0.89|0.0090
73816563|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6237|TWO_SIDED|90.0|0.93|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||1.04|0.93|0.6237
73896507|NCT00913458|147326248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.2168|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.0|-1.0|0.2168
73816564|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.008|TWO_SIDED|90.0|0.87|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.97|0.87|0.0080
73816565|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0105|TWO_SIDED|90.0|0.86|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||0.97|0.86|0.0105
73816566|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.0217|TWO_SIDED|90.0|0.86|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.98|0.86|0.0217
73816567|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.0031|TWO_SIDED|90.0|0.82|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||0.94|0.82|0.0031
73816568|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.774|TWO_SIDED|90.0|0.95|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.07|0.95|0.7740
73816569|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.1783|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.01|0.89|0.1783
73816570|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0219|TWO_SIDED|90.0|0.84|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||0.97|0.84|0.0219
73816571|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.0719|TWO_SIDED|90.0|0.85|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||0.99|0.85|0.0719
73816572|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.2199|TWO_SIDED|90.0|0.85|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.02|0.85|0.2199
73816573|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.4928|TWO_SIDED|90.0|0.87|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.06|0.87|0.4928
73816574|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.3419|TWO_SIDED|90.0|0.85|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.05|0.85|0.3419
73816575|NCT02913105|147182399|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7281|TWO_SIDED|90.0|0.88|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.09|0.88|0.7281
73896508|NCT00913458|147326248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.2131|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.0|-1.0|0.2131
73816576|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.318|TWO_SIDED|90.0|0.97|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.12|0.97|0.3180
73816577|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.6576|TWO_SIDED|90.0|0.95|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||1.10|0.95|0.6576
73816578|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.6035|TWO_SIDED|90.0|0.9|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||1.06|0.90|0.6035
73816579|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.3261|TWO_SIDED|90.0|0.96|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.17|0.96|0.3261
73816580|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.5246|TWO_SIDED|90.0|0.94|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.15|0.94|0.5246
73816581|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.7519|TWO_SIDED|90.0|0.92|1.14|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.14|0.92|0.7519
73816582|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9577|TWO_SIDED|90.0|0.89|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.12|0.89|0.9577
73816583|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.1||||0.016|TWO_SIDED|90.0|1.03|1.18|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.18|1.03|0.0160
73816584|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.13||||0.0052|TWO_SIDED|90.0|1.05|1.21|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||1.21|1.05|0.0052
73816585|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.1822|TWO_SIDED|90.0|0.99|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||1.15|0.99|0.1822
73816586|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.14||||0.0159|TWO_SIDED|90.0|1.04|1.24|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.24|1.04|0.0159
73816587|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.1524|TWO_SIDED|90.0|0.99|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.19|0.99|0.1524
73816588|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.1749|TWO_SIDED|90.0|0.98|1.2|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.20|0.98|0.1749
73816589|NCT02913105|147182399|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.7503|TWO_SIDED|90.0|0.92|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.13|0.92|0.7503
73816590|NCT02913105|147182400|OTHER|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|7.01|STANDARD_ERROR_OF_MEAN|5.52||0.2073|TWO_SIDED|90.0|-2.161|16.178|||ANCOVA|||||16.178|-2.161|0.2073
73816591|NCT02913105|147182400|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|7.23|STANDARD_ERROR_OF_MEAN|5.62||0.2014|TWO_SIDED|90.0|-2.106|16.563|||ANCOVA|||||16.563|-2.106|0.2014
73816592|NCT02913105|147182400|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|4.93||0.9645|TWO_SIDED|90.0|-7.974|8.414|||ANCOVA|||||8.414|-7.974|0.9645
73816593|NCT01153009|147182453|SUPERIORITY_OR_OTHER||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.21||0.224|TWO_SIDED|95.0|-3.86|0.91||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 15 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in a sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||0.91|-3.86|0.224
73816594|NCT01153009|147182453|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.21||0.023|TWO_SIDED|95.0|-5.12|-0.38||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.025, hierarchical testing continues for this dose.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-0.38|-5.12|0.023
73816595|NCT01153009|147182453|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-6.46|-1.69|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-1.69|-6.46|<0.001
73816596|NCT01153009|147182454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.348|TWO_SIDED|95.0|0.786|1.984|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.984|0.786|0.348
73816597|NCT01153009|147182454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.257||||0.332|TWO_SIDED|95.0|0.792|1.994||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.994|0.792|0.332
73816598|NCT01153009|147182454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.991||||0.004|TWO_SIDED|95.0|1.25|3.171|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.171|1.250|0.004
73816599|NCT01153009|147182455|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.4|TWO_SIDED|95.0|-0.39|0.16|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.16|-0.39|0.400
73816600|NCT01153009|147182455|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.139||0.177|TWO_SIDED|95.0|-0.46|0.08|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.08|-0.46|0.177
73816601|NCT01153009|147182455|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.139||0.014|TWO_SIDED|95.0|-0.61|-0.07|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||-0.07|-0.61|0.014
73816602|NCT01153009|147182456|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|2.286||0.684|TWO_SIDED|95.0|-3.58|5.45|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||5.45|-3.58|0.684
73816603|NCT01153009|147182456|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|2.419||0.797|TWO_SIDED|95.0|-5.4|4.15|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||4.15|-5.40|0.797
73816604|NCT01153009|147182456|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.05|STANDARD_ERROR_OF_MEAN|2.278||0.078|TWO_SIDED|95.0|-8.54|0.45|||Mixed model for repeated mesurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||0.45|-8.54|0.078
73816605|NCT01153009|147182457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.053||||0.845|TWO_SIDED|95.0|0.625|1.775|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.775|0.625|0.845
73816606|NCT01153009|147182457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.192||||0.503|TWO_SIDED|95.0|0.713|1.994|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.994|0.713|0.503
73816607|NCT01153009|147182457|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.098||||0.728|TWO_SIDED|95.0|0.648|1.86|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.860|0.648|0.728
73816608|NCT01153009|147182458|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|1.111||0.962|TWO_SIDED|95.0|-2.24|2.13|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||2.13|-2.24|0.962
73816609|NCT01153009|147182458|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|1.103||0.427|TWO_SIDED|95.0|-3.05|1.29|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||1.29|-3.05|0.427
73816610|NCT01153009|147182458|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|1.123||0.078|TWO_SIDED|95.0|-4.19|0.22|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||0.22|-4.19|0.078
73816611|NCT04494425|147182466|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.75|||Log Rank|The analysis was performed using the stratified log-rank test.|HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for prior cyclin-dependent kinase (CDK)4/6 inhibitor use (yes versus no) and HER2 IHC expression (IHC 1+ versus IHC 2+/ISH-) and ties handled by Efron approach.|||0.75|0.52|<0.0001
73816612|NCT00703326|147182502|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.077|TWO_SIDED|95.0|0.75|1.01|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.01|0.75|0.077
73816613|NCT00703326|147182503|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.487|TWO_SIDED|95.0|0.81|1.1||The gate-keeping strategy used to control overall type 1 error 0.05 (2-sided) or 0.025 (1-sided) to analyze progression-free survival (PFS) and OS. At final PFS analysis only if primary PFS test was significant would analysis of OS be inferential.|Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.10|0.81|0.487
73816614|NCT00703326|147182504|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.033|TWO_SIDED|95.0|0.73|0.99|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||0.99|0.73|0.033
73816615|NCT00703326|147182505|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.027|TWO_SIDED|95.0|1.03|1.71|||Stratified Cochran-Mantel-Haenszel(SCMH)|SCMH used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|Stratified odds ratio was calculated considering the IWRS stratification factors.|||1.71|1.03|0.027
73816616|NCT00703326|147182506|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.15|TWO_SIDED|95.0|0.67|1.06|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.06|0.67|0.150
73816617|NCT00703326|147182507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||||||P-value is for end of therapy. Analysis of covariance (ANCOVA) adjusted for baseline score was used to compare the 2 treatment arms.|ANCOVA|||||||0.539
73816618|NCT02242019|147182518|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73816619|NCT02242019|147182519|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73816620|NCT05206734|147182544|OTHER||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|1.12|1.46|||||HR was calculated using a Cox Proportional Hazard model adjusted for age,sex,socioeconomic status, ethnicity and common childhood conditions. Reflects a comparison of the incidence rates between participants diagnosed with IBD and those without IBD.|||1.46|1.12|
73816621|NCT05206734|147182545|OTHER||Risk Ratio (RR)|1.82|||||TWO_SIDED|95.0|1.33|2.52|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.52|1.33|
73816622|NCT05206734|147182546|OTHER||Hazard Ratio (HR)|1.63|||||TWO_SIDED|95.0|1.02|2.62|||||HR calculated using Cox regression models adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.62|1.02|
73816623|NCT05206734|147182547|OTHER||Risk Ratio (RR)|2.78|||||TWO_SIDED|95.0|1.76|4.43|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||4.43|1.76|
73816624|NCT05206734|147182549|OTHER||Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|1.12|1.58|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||1.58|1.12|
73816625|NCT05206734|147182550|OTHER||Risk Ratio (RR)|1.87|||||TWO_SIDED|95.0|1.29|2.75|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.75|1.29|
73816626|NCT02330172|147182553|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73816627|NCT02330172|147182554|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73816628|NCT00734656|147182555|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||null hypothesis - dutasteride does not affect blood alcohol following standardized dose of alcohol (0.8 gr/kg)||||0.28
73816629|NCT00734656|147182556|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the sedative effect of alcohol||||0.010
73816630|NCT00734656|147182557|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the stimulating effect of alcohol||||0.17
73816631|NCT00734656|147182558|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||null hypothesis - A single 4 mg dose of dutasteride does not reduce serum 3a-androstanediol glucuronide levels||||<0.001
73816632|NCT03214679|147182565|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<.001
73816633|NCT01601067|147182570|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||.002
73816634|NCT01601067|147182571|SUPERIORITY|||||||0.91||||||heavy drinking days|Mixed Models Analysis|||||||.91
73816635|NCT02412878|147182587|SUPERIORITY||Odds Ratio (OR)|2.485|||<|0.0001|TWO_SIDED|95.0|1.716|3.598||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Cochran-Mantel-Haenszel|One-sided p-value from CMH test stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method stratified by the randomization stratification factors.|||3.598|1.716|< 0.0001
73816636|NCT02412878|147182587|SUPERIORITY||Odds Ratio (OR)|2.466|||<|0.0001|TWO_SIDED|95.0|1.707|3.563|||Fisher Exact||Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method.|||3.563|1.707|<0.0001
73816637|NCT02412878|147182588|SUPERIORITY||Hazard Ratio (HR)|0.693||||0.0014|TWO_SIDED|95.0|0.544|0.883||Progression-free survival, overall response rate, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.|To ensure proper control of type I error, analysis of PFS was performed under a group sequential design framework with the stopping boundaries constructed using the Lan-DeMets spending function with an O'Brien-Fleming approach. The inferential comparison between the 2 treatment groups for PFS used the 1-sided log-rank test stratified by the randomization stratification factors. A 1-sided p-value was compared against the prespecified adjusted alpha value of 0.011 to determine significance.||0.883|0.544|0.0014
73816638|NCT02412878|147182588|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0033|TWO_SIDED|95.0|0.567|0.913|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.|||0.913|0.567|0.0033
73816639|NCT02412878|147182589|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.107|TWO_SIDED|95.0|0.563|1.138||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.|||1.138|0.563|0.1070
73816640|NCT02412878|147182589|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.1326|TWO_SIDED|95.0|0.578|1.164|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.|||1.164|0.578|0.1326
73816641|NCT01212159|147182619|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED|||||Comparison of mean reduction in LDL cholesterol between no monitor (control) and monitor (intervention) groups|t-test, 2 sided|||Paired t-test analysis of 6 month change in LDL cholesterol for no monitor and self monitor groups Independent sample t-test to compare ldl change between groups||||0.391
73816642|NCT01306214|147182622|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|97.5|-0.61|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 10 mg - Adjusted mean of placebo.|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~Hypothesis test:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo"||-0.27|-0.61|<0.0001
73816643|NCT01306214|147182622|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.69|-0.35||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo"||-0.35|-0.69|<0.0001
73816644|NCT01306214|147182623|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.83|STANDARD_ERROR_OF_MEAN|3.05||0.004|TWO_SIDED|97.5|-15.69|-1.97||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo"||-1.97|-15.69|0.004
73816645|NCT01306214|147182623|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.22|STANDARD_ERROR_OF_MEAN|3.05||0.0003|TWO_SIDED|97.5|-18.09|-4.36||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo.|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo"||-4.36|-18.09|0.0003
73816646|NCT01306214|147182624|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.39|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|97.5|-3.54|-1.24||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo"||-1.24|-3.54|<0.0001
73816647|NCT01306214|147182624|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.48|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|97.5|-3.63|-1.33||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|hypothesis test: H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo||-1.33|-3.63|<0.0001
73816648|NCT01306214|147182625|NON_INFERIORITY_OR_EQUIVALENCE|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|H0: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo \>0.3 Ha: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo ≤0.3||-0.13|-0.62|<0.0001
73816649|NCT01306214|147182625|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.11||0.0005|TWO_SIDED|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo"||-0.13|-0.62|0.0005
73816650|NCT01306214|147182625|NON_INFERIORITY_OR_EQUIVALENCE|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|H013: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo \>0.3 Ha13: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo ≤0.3||-0.22|-0.70|<0.0001
73816651|NCT01306214|147182625|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo"||-0.22|-0.70|<0.0001
73816652|NCT01026818|147182626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.675|TWO_SIDED|95.0|0.63|2.06||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.||2.06|0.63|0.675
73816653|NCT01026818|147182626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.704|TWO_SIDED|95.0|0.48|1.65||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.||1.65|0.48|0.704
73816654|NCT01026818|147182627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.016|TWO_SIDED|95.0|1.16|3.99||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||3.99|1.16|0.016
73816655|NCT01026818|147182627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.21|TWO_SIDED|95.0|0.79|2.85||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.85|0.79|0.210
73816656|NCT01026818|147182627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.273|TWO_SIDED|95.0|0.79|2.28||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.28|0.79|0.273
73816657|NCT01026818|147182627|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.259|TWO_SIDED|95.0|0.8|2.29||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.29|0.80|0.259
73816658|NCT01026818|147182628|SUPERIORITY_OR_OTHER||LS Mean Differences|2.8|STANDARD_ERROR_OF_MEAN|1.03||0.007|TWO_SIDED|95.0|0.76|4.83||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.83|0.76|0.007
73816659|NCT01026818|147182628|SUPERIORITY_OR_OTHER||LS Mean differences|1.59|STANDARD_ERROR_OF_MEAN|1.02||0.118|TWO_SIDED|95.0|-0.41|3.6||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.60|-0.41|0.118
73816660|NCT01026818|147182628|SUPERIORITY_OR_OTHER||LS Mean Differences|0.26|STANDARD_ERROR_OF_MEAN|1.04||0.802|TWO_SIDED|95.0|-1.79|2.31||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.31|-1.79|0.802
73816661|NCT01026818|147182628|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.22|STANDARD_ERROR_OF_MEAN|1.02||0.83|TWO_SIDED|95.0|-2.23|1.79||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.79|-2.23|0.830
73816662|NCT01026818|147182628|SUPERIORITY_OR_OTHER||LS Mean Differences|1.62|STANDARD_ERROR_OF_MEAN|1.22||0.184|TWO_SIDED|95.0|-0.78|4.03||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.03|-0.78|0.184
73816663|NCT01026818|147182628|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81|STANDARD_ERROR_OF_MEAN|1.2||0.5|TWO_SIDED|95.0|-1.54|3.16||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.16|-1.54|0.500
73816664|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.37|STANDARD_ERROR_OF_MEAN|0.39||0.34||95.0|-0.39|1.14||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.14|-0.39|0.340
73816665|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.09|STANDARD_ERROR_OF_MEAN|0.38||0.821|TWO_SIDED|95.0|-0.67|0.84||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.84|-0.67|0.821
73816666|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.46|STANDARD_ERROR_OF_MEAN|0.42||0.268|TWO_SIDED|95.0|-0.36|1.28||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.28|-0.36|0.268
73816667|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.998|TWO_SIDED|95.0|-0.8|0.8||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.80|-0.80|0.998
73816668|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|0.42||0.728|TWO_SIDED|95.0|-0.68|0.97||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.97|-0.68|0.728
73816669|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.52|STANDARD_ERROR_OF_MEAN|0.41||0.203|TWO_SIDED|95.0|-1.33|0.28||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.28|-1.33|0.203
73816670|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.24||0.95|TWO_SIDED|95.0|-0.46|0.49||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.49|-0.46|0.950
73816671|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.01|STANDARD_ERROR_OF_MEAN|0.24||0.95|TWO_SIDED|95.0|-0.45|0.48||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.48|-0.45|0.950
73816672|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.06|STANDARD_ERROR_OF_MEAN|0.23||0.792|TWO_SIDED|95.0|-0.39|0.51||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.51|-0.39|0.792
73816673|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.11|STANDARD_ERROR_OF_MEAN|0.23||0.631|TWO_SIDED|95.0|-0.34|0.55||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.55|-0.34|0.631
73816674|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.691|TWO_SIDED|95.0|-0.38|0.58||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.58|-0.38|0.691
73816675|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.801|TWO_SIDED|95.0|-0.53|0.41||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.41|-0.53|0.801
73816676|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.93|STANDARD_ERROR_OF_MEAN|0.5||0.065|TWO_SIDED|95.0|-0.06|1.92||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.92|-0.06|0.065
73816677|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.54|STANDARD_ERROR_OF_MEAN|0.49||0.274|TWO_SIDED|95.0|-0.43|1.51||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.51|-0.43|0.274
73816678|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.48|STANDARD_ERROR_OF_MEAN|0.53||0.359|TWO_SIDED|95.0|-0.55|1.52||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.52|-0.55|0.359
73816679|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.09|STANDARD_ERROR_OF_MEAN|0.52||0.863|TWO_SIDED|95.0|-0.93|1.11||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.11|-0.93|0.863
73816680|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.56|STANDARD_ERROR_OF_MEAN|0.56||0.314|TWO_SIDED|95.0|-0.53|1.66||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.66|-0.53|0.314
73816681|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.06|STANDARD_ERROR_OF_MEAN|0.54||0.91|TWO_SIDED|95.0|-1.13|1.01||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.01|-1.13|0.910
73816682|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.19|STANDARD_ERROR_OF_MEAN|0.3||0.532|TWO_SIDED|95.0|-0.4|0.78||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.78|-0.40|0.532
73816683|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|0.3||0.62|TWO_SIDED|95.0|-0.43|0.73||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.73|-0.43|0.620
73816684|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.08|STANDARD_ERROR_OF_MEAN|0.3||0.792|TWO_SIDED|95.0|-0.67|0.51||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.51|-0.67|0.792
73816685|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.24|STANDARD_ERROR_OF_MEAN|0.29||0.41|TWO_SIDED|95.0|-0.82|0.34||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.34|-0.82|0.410
73816686|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.02|STANDARD_ERROR_OF_MEAN|0.34||0.955||95.0|-0.68|0.65||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.65|-0.68|0.955
73816687|NCT01026818|147182629|SUPERIORITY_OR_OTHER||LS Mean Differences|0.05|STANDARD_ERROR_OF_MEAN|0.33||0.868|TWO_SIDED|95.0|-0.59|0.7||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.70|-0.59|0.868
73816688|NCT01026818|147182630|SUPERIORITY_OR_OTHER||LS Mean Differences|0.33|STANDARD_ERROR_OF_MEAN|0.12||0.005|TWO_SIDED|95.0|0.1|0.56||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.56|0.10|0.005
73816689|NCT01026818|147182630|SUPERIORITY_OR_OTHER||LS Mean Differences|0.23|STANDARD_ERROR_OF_MEAN|0.11||0.041|TWO_SIDED|95.0|0.01|0.45||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.45|0.01|0.041
73816690|NCT01026818|147182630|SUPERIORITY_OR_OTHER||LS Mean Differences|0.28|STANDARD_ERROR_OF_MEAN|0.13||0.035||95.0|0.02|0.54||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.54|0.02|0.035
73816691|NCT01026818|147182630|SUPERIORITY_OR_OTHER||LS Mean Differences|0.13|STANDARD_ERROR_OF_MEAN|0.13||0.316|TWO_SIDED|95.0|-0.12|0.38||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.38|-0.12|0.316
73816692|NCT01026818|147182631|SUPERIORITY_OR_OTHER||LS Mean Differences|1.75|STANDARD_ERROR_OF_MEAN|1.02||0.086|TWO_SIDED|95.0|-0.25|3.76||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.76|-0.25|0.086
73816693|NCT01026818|147182631|SUPERIORITY_OR_OTHER||LS Mean Differences|0.47|STANDARD_ERROR_OF_MEAN|1.0||0.637|TWO_SIDED|95.0|-1.5|2.45||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.45|-1.50|0.637
73816694|NCT01026818|147182631|SUPERIORITY_OR_OTHER||LS Mean Differences|0.17|STANDARD_ERROR_OF_MEAN|1.2||0.885|TWO_SIDED|95.0|-2.18|2.53||P-value is for sexual relationship - Month 13.5|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.53|-2.18|0.885
73816695|NCT01026818|147182631|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.04|STANDARD_ERROR_OF_MEAN|1.17||0.972|TWO_SIDED|95.0|-2.34|2.25||P-value is for sexual relationship - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.25|-2.34|0.972
73816696|NCT01026818|147182631|SUPERIORITY_OR_OTHER||LS Mean Differences|0.27|STANDARD_ERROR_OF_MEAN|0.55||0.621|TWO_SIDED|95.0|-0.81|1.36||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.36|-0.81|0.621
73816697|NCT01026818|147182631|SUPERIORITY_OR_OTHER||LS Mean Differences|0.29|STANDARD_ERROR_OF_MEAN|0.54||0.598|TWO_SIDED|95.0|-0.78|1.35||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.35|-0.78|0.598
73816698|NCT01026818|147182631|SUPERIORITY_OR_OTHER||LS Mean Differences|0.06|STANDARD_ERROR_OF_MEAN|0.59||0.923|TWO_SIDED|95.0|-1.1|1.21||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.21|-1.10|0.923
73816699|NCT01026818|147182631|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.857|TWO_SIDED|95.0|-1.03|1.24||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.24|-1.03|0.857
73816700|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|14.87|STANDARD_ERROR_OF_MEAN|5.57||0.008|TWO_SIDED|95.0|3.92|25.83||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||25.83|3.92|0.008
73816701|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|11.34|STANDARD_ERROR_OF_MEAN|5.45||0.038|TWO_SIDED|95.0|0.63|22.04||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||22.04|0.63|0.038
73816702|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|8.91|STANDARD_ERROR_OF_MEAN|6.15||0.148|TWO_SIDED|95.0|-3.18|21.0||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||21.00|-3.18|0.148
73816703|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|5.37|STANDARD_ERROR_OF_MEAN|6.03||0.373|TWO_SIDED|95.0|-6.48|17.23||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.23|-6.48|0.373
73816704|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|10.9|STANDARD_ERROR_OF_MEAN|4.96||0.029|TWO_SIDED|95.0|1.14|20.66||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.66|1.14|0.029
73816705|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|4.53|STANDARD_ERROR_OF_MEAN|4.91||0.357|TWO_SIDED|95.0|-5.12|14.17||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||14.17|-5.12|0.357
73816706|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|16.33|STANDARD_ERROR_OF_MEAN|5.42||0.003|TWO_SIDED|95.0|5.68|26.98||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||26.98|5.68|0.003
73816707|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|6.62|STANDARD_ERROR_OF_MEAN|5.3||0.212|TWO_SIDED|95.0|-3.8|17.04||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.04|-3.80|0.212
73816708|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|4.55|STANDARD_ERROR_OF_MEAN|6.17||0.461|TWO_SIDED|95.0|-7.58|16.68||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||16.68|-7.58|0.461
73816709|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.26|STANDARD_ERROR_OF_MEAN|6.05||0.835|TWO_SIDED|95.0|-13.16|10.63||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||10.63|-13.16|0.835
73816710|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|13.36|STANDARD_ERROR_OF_MEAN|6.15||0.03|TWO_SIDED|95.0|1.27|25.46||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||25.46|1.27|0.030
73816711|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|5.96|STANDARD_ERROR_OF_MEAN|6.07||0.326|TWO_SIDED|95.0|-5.97|17.89||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.89|-5.97|0.326
73816712|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|12.06|STANDARD_ERROR_OF_MEAN|5.13||0.019||95.0|1.98|22.15||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||22.15|1.98|0.019
73816713|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|2.48|STANDARD_ERROR_OF_MEAN|5.02||0.621|TWO_SIDED|95.0|-7.38|12.35||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.35|-7.38|0.621
73816714|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|0.23|STANDARD_ERROR_OF_MEAN|5.73||0.968||95.0|-11.03|11.49||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||11.49|-11.03|0.968
73816715|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|-5.51|STANDARD_ERROR_OF_MEAN|5.62||0.327|TWO_SIDED|95.0|-16.55|5.54||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.54|-16.55|0.327
73816716|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|11.67|STANDARD_ERROR_OF_MEAN|6.32||0.066|TWO_SIDED|95.0|-0.76|24.09||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||24.09|-0.76|0.066
73816717|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|5.09|STANDARD_ERROR_OF_MEAN|6.23||0.415|TWO_SIDED|95.0|-7.17|17.34||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.34|-7.17|0.415
73816718|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|11.87|STANDARD_ERROR_OF_MEAN|4.61||0.011|TWO_SIDED|95.0|2.79|20.94||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.94|2.79|0.011
73816719|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|3.85|STANDARD_ERROR_OF_MEAN|4.51||0.394|TWO_SIDED|95.0|-5.03|12.72||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.72|-5.03|0.394
73816720|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.94|STANDARD_ERROR_OF_MEAN|4.75||0.684|TWO_SIDED|95.0|-11.28|7.41||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||7.41|-11.28|0.684
73816721|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|-7.14|STANDARD_ERROR_OF_MEAN|4.66||0.126|TWO_SIDED|95.0|-16.3|2.02||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.02|-16.30|0.126
73816722|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|11.52|STANDARD_ERROR_OF_MEAN|6.13||0.061|TWO_SIDED|95.0|-0.53|23.57||P-value is for Q4 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||23.57|-0.53|0.061
73816723|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|5.06|STANDARD_ERROR_OF_MEAN|6.05||0.403|TWO_SIDED|95.0|-6.83|16.95||P-value is for Q4 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||16.95|-6.83|0.403
73816724|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|11.38|STANDARD_ERROR_OF_MEAN|4.58||0.013||95.0|2.38|20.38||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.38|2.38|0.013
73816725|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|3.69|STANDARD_ERROR_OF_MEAN|4.47||0.41|TWO_SIDED|95.0|-5.11|12.49||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.49|-5.11|0.410
73816726|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|-2.85|STANDARD_ERROR_OF_MEAN|4.61||0.537|TWO_SIDED|95.0|-11.92|6.22||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||6.22|-11.92|0.537
73816727|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|-8.59|STANDARD_ERROR_OF_MEAN|4.52||0.058|TWO_SIDED|95.0|-17.48|0.3||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.30|-17.48|0.058
73816728|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|11.44|STANDARD_ERROR_OF_MEAN|6.09||0.061|TWO_SIDED|95.0|-0.54|23.41||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||23.41|-0.54|0.061
73816729|NCT01026818|147182642|SUPERIORITY_OR_OTHER||LS Mean Differences|5.59|STANDARD_ERROR_OF_MEAN|6.01||0.353|TWO_SIDED|95.0|-6.23|17.4||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.40|-6.23|0.353
73816730|NCT01026818|147182643|SUPERIORITY_OR_OTHER||LS Mean Differences|-5.12|STANDARD_ERROR_OF_MEAN|3.66||0.162|TWO_SIDED|95.0|-12.32|2.08|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.||||2.08|-12.32|0.162
73816731|NCT01026818|147182643|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.88|STANDARD_ERROR_OF_MEAN|3.61||0.603||95.0|-8.99|5.24|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.||||5.24|-8.99|0.603
73816732|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|3.49|STANDARD_ERROR_OF_MEAN|2.7||0.196|TWO_SIDED|95.0|-1.82|8.8||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||8.80|-1.82|0.196
73816733|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|0.53|STANDARD_ERROR_OF_MEAN|2.65||0.841|TWO_SIDED|95.0|-4.69|5.75||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.75|-4.69|0.841
73816734|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|1.98|STANDARD_ERROR_OF_MEAN|2.76||0.474|TWO_SIDED|95.0|-3.45|7.4||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||7.40|-3.45|0.474
73816735|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|2.7||0.971|TWO_SIDED|95.0|-5.21|5.41||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.41|-5.21|0.971
73816736|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|1.57|STANDARD_ERROR_OF_MEAN|1.32||0.236|TWO_SIDED|95.0|-1.03|4.17||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.17|-1.03|0.236
73816737|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|1.02|STANDARD_ERROR_OF_MEAN|1.29||0.429|TWO_SIDED|95.0|-1.52|3.56||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.56|-1.52|0.429
73816738|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|1.56|STANDARD_ERROR_OF_MEAN|1.36||0.252|TWO_SIDED|95.0|-1.12|4.24||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.24|-1.12|0.252
73816739|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|1.52|STANDARD_ERROR_OF_MEAN|1.32||0.251|TWO_SIDED|95.0|-1.08|4.11||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.11|-1.08|0.251
73816740|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.54|STANDARD_ERROR_OF_MEAN|1.27||0.671|TWO_SIDED|95.0|-3.03|1.95||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.95|-3.03|0.671
73816741|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.21|STANDARD_ERROR_OF_MEAN|1.24||0.868|TWO_SIDED|95.0|-2.64|2.23||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.23|-2.64|0.868
73816742|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|1.25||0.938|TWO_SIDED|95.0|-2.37|2.57||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.57|-2.37|0.938
73816743|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.29|STANDARD_ERROR_OF_MEAN|1.22||0.813|TWO_SIDED|95.0|-2.69|2.12||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.12|-2.69|0.813
73816744|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|9.55|STANDARD_ERROR_OF_MEAN|3.28||0.004|TWO_SIDED|95.0|3.1|15.99||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||15.99|3.10|0.004
73816745|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|2.69|STANDARD_ERROR_OF_MEAN|3.21||0.403|TWO_SIDED|95.0|-3.63|9.0||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||9.00|-3.63|0.403
73816746|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|3.18|STANDARD_ERROR_OF_MEAN|3.82||0.406|TWO_SIDED|95.0|-4.34|10.69||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||10.69|-4.34|0.406
73816747|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.79|STANDARD_ERROR_OF_MEAN|3.72||0.832|TWO_SIDED|95.0|-8.11|6.53||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||6.53|-8.11|0.832
73816748|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|1.9|STANDARD_ERROR_OF_MEAN|1.47||0.197|TWO_SIDED|95.0|-0.99|4.79||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.79|-0.99|0.197
73816749|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|2.89|STANDARD_ERROR_OF_MEAN|1.44||0.045|TWO_SIDED|95.0|0.06|5.72||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.72|0.06|0.045
73816750|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.53|STANDARD_ERROR_OF_MEAN|1.34||0.692|TWO_SIDED|95.0|-3.16|2.1||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.10|-3.16|0.692
73816751|NCT01026818|147182647|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.09|STANDARD_ERROR_OF_MEAN|1.3||0.943|TWO_SIDED|95.0|-2.65|2.46||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.46|-2.65|0.943
73816752|NCT01026818|147182648|SUPERIORITY_OR_OTHER||LS Mean Differences|4.2|STANDARD_ERROR_OF_MEAN|1.89||0.028|TWO_SIDED|95.0|0.47|7.93||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||7.93|0.47|0.028
73816753|NCT01026818|147182648|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.53|STANDARD_ERROR_OF_MEAN|1.87||0.413|TWO_SIDED|95.0|-5.2|2.14||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||2.14|-5.20|0.413
73816754|NCT01026818|147182648|SUPERIORITY_OR_OTHER||LS Mean Differences|2.37|STANDARD_ERROR_OF_MEAN|1.49||0.112|TWO_SIDED|95.0|-0.55|5.3||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||5.30|-0.55|0.112
73816755|NCT01026818|147182648|SUPERIORITY_OR_OTHER||LS Mean Differences|3.16|STANDARD_ERROR_OF_MEAN|1.46||0.031|TWO_SIDED|95.0|0.29|6.03||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||6.03|0.29|0.031
73816756|NCT01031004|147182661|SUPERIORITY_OR_OTHER|||||||0.0466||95.0|||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.0466
73816757|NCT01031004|147182662|SUPERIORITY_OR_OTHER|||||||0.1069||95.0|||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.1069
73816758|NCT01031004|147182663|SUPERIORITY_OR_OTHER|||||||0.4605||95.0|||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.4605
73816759|NCT01031004|147182664|SUPERIORITY_OR_OTHER|||||||0.5774||95.0|||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.5774
73816760|NCT01031004|147182665|SUPERIORITY_OR_OTHER|||||||0.6403||95.0|||||t-test, 2 sided|||The hypothesis is that narafilcon B will not be statistically different from etafilcon A.||||0.6403
73816761|NCT01031004|147182666|SUPERIORITY_OR_OTHER|||||||0.7217||95.0|||||t-test, 2 sided|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.7217
73816762|NCT04575584|147182676|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.562|TWO_SIDED|95.0|0.68|1.45|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.45|0.68|0.5620
73816763|NCT04575584|147182676|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.3145|TWO_SIDED|95.0|0.78|1.65|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.65|0.78|0.3145
73816764|NCT04575584|147182676|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.4894|TWO_SIDED|95.0|0.69|1.47|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.47|0.69|0.4894
73816765|NCT04575584|147182679|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1642|TWO_SIDED|95.0|-2.3|12.1|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||12.1|-2.3|0.1642
73816766|NCT04575584|147182679|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.09|TWO_SIDED|95.0|-1.1|13.9|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||13.9|-1.1|0.0900
73816767|NCT04575584|147182679|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.1594|TWO_SIDED|95.0|-2.3|12.3|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||12.3|-2.3|0.1594
73816768|NCT04575584|147182680|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3623|TWO_SIDED|95.0|0.73|2.35|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. Confidence intervals (CIs) are based on Wald Chi-Square Test.|||2.35|0.73|0.3623
73816769|NCT04575584|147182680|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5714|TWO_SIDED|95.0|0.66|2.12|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.12|0.66|0.5714
73816770|NCT04575584|147182680|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9313|TWO_SIDED|95.0|0.54|1.75|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.54|0.9313
73816771|NCT04575584|147182681|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4398|TWO_SIDED|95.0|0.7|2.3|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.30|0.70|0.4398
73816772|NCT04575584|147182681|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6277|TWO_SIDED|95.0|0.47|1.57|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.57|0.47|0.6277
73816773|NCT04575584|147182681|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7069|TWO_SIDED|95.0|0.49|1.62|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.62|0.49|0.7069
73816774|NCT04575584|147182682|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2422|TWO_SIDED|95.0|0.77|2.85|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.85|0.77|0.2422
73816775|NCT04575584|147182682|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4789|TWO_SIDED|95.0|0.66|2.44|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.44|0.66|0.4789
73816776|NCT04575584|147182682|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6052|TWO_SIDED|95.0|0.45|1.59|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.59|0.45|0.6052
73816777|NCT04575584|147182683|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2644|TWO_SIDED|95.0|0.75|2.88|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.75|0.2644
73816778|NCT04575584|147182683|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2184|TWO_SIDED|95.0|0.77|3.14|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.14|0.77|0.2184
73816779|NCT04575584|147182683|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9771|TWO_SIDED|95.0|0.53|1.94|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.94|0.53|0.9771
73816780|NCT04575584|147182684|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9945|TWO_SIDED|95.0|0.46|2.06|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.06|0.46|0.9945
73816781|NCT04575584|147182684|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3227|TWO_SIDED|95.0|0.67|3.37|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.37|0.67|0.3227
73816782|NCT04575584|147182684|SUPERIORITY||Odds Ratio (OR)|0.79||||0.52|TWO_SIDED|95.0|0.39|1.61|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.39|0.5200
73816783|NCT04575584|147182685|SUPERIORITY||Odds Ratio (OR)|1.25||||0.4472|TWO_SIDED|95.0|0.7|2.25|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.25|0.70|0.4472
73816784|NCT04575584|147182685|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5714|TWO_SIDED|95.0|0.66|2.12|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.12|0.66|0.5714
73816785|NCT04575584|147182685|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9313|TWO_SIDED|95.0|0.54|1.75|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.54|0.9313
73816786|NCT04575584|147182686|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5222|TWO_SIDED|95.0|0.67|2.21|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.21|0.67|0.5222
73816787|NCT04575584|147182686|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6277|TWO_SIDED|95.0|0.47|1.57|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.57|0.47|0.6277
73816788|NCT04575584|147182686|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7069|TWO_SIDED|95.0|0.49|1.62|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.62|0.49|0.7069
73816789|NCT04575584|147182687|SUPERIORITY||Odds Ratio (OR)|1.46||||0.2627|TWO_SIDED|95.0|0.75|2.8|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.80|0.75|0.2627
73816790|NCT04575584|147182687|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4789|TWO_SIDED|95.0|0.66|2.44|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.44|0.66|0.4789
73816791|NCT04575584|147182687|SUPERIORITY||Odds Ratio (OR)|0.84||||0.5938|TWO_SIDED|95.0|0.45|1.58|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.58|0.45|0.5938
73816792|NCT04575584|147182688|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2644|TWO_SIDED|95.0|0.75|2.88|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.75|0.2644
73816793|NCT04575584|147182688|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2184|TWO_SIDED|95.0|0.77|3.14|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.14|0.77|0.2184
73816794|NCT04575584|147182688|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9771|TWO_SIDED|95.0|0.53|1.94|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.94|0.53|0.9771
73816795|NCT04575584|147182689|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9445|TWO_SIDED|95.0|0.46|2.06|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.06|0.46|0.9445
73816796|NCT04575584|147182689|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3227|TWO_SIDED|95.0|0.67|3.37|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.37|0.67|0.3227
73816797|NCT04575584|147182689|SUPERIORITY||Odds Ratio (OR)|0.79||||0.52|TWO_SIDED|95.0|0.39|1.61|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.39|0.5200
73816798|NCT04575584|147182690|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8732|TWO_SIDED|95.0|0.46|2.47|||Wald Chi-Square||Proportional odds model with National Early Warning Score (NEWS) categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.47|0.46|0.8732
73816799|NCT04575584|147182690|SUPERIORITY||Odds Ratio (OR)|0.54||||0.1277|TWO_SIDED|95.0|0.25|1.19|||Wald Chi-square||Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.19|0.25|0.1277
73816800|NCT04575584|147182690|SUPERIORITY||Odds Ratio (OR)|0.73||||0.4326|TWO_SIDED|95.0|0.33|1.61|||Wald Chi-Square||Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.33|0.4326
73816801|NCT04575584|147182691|SUPERIORITY||Odds Ratio (OR)|1.2||||0.683|TWO_SIDED|95.0|0.5|2.88|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.50|0.6830
73816802|NCT04575584|147182691|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.42|2.39|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.39|0.42|1.000
73816803|NCT04575584|147182691|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8244|TWO_SIDED|95.0|0.37|2.2|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.20|0.37|0.8244
73816804|NCT04575584|147182692|SUPERIORITY||Odds Ratio (OR)|0.77||||0.5022|TWO_SIDED|95.0|0.36|1.64|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.64|0.36|0.5022
73816805|NCT04575584|147182692|SUPERIORITY||Odds Ratio (OR)|0.78||||0.5204|TWO_SIDED|95.0|0.37|1.64|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.64|0.37|0.5204
73816806|NCT04575584|147182692|SUPERIORITY||Odds Ratio (OR)|0.52||||0.0991|TWO_SIDED|95.0|0.24|1.13|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.13|0.24|0.0991
73816807|NCT04575584|147182693|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6346|TWO_SIDED|95.0|0.6|2.29|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.29|0.60|0.6346
73816808|NCT04575584|147182693|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7596|TWO_SIDED|95.0|0.46|1.75|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.46|0.7596
73816809|NCT04575584|147182693|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8879|TWO_SIDED|95.0|0.49|1.84|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.84|0.49|0.8879
73816810|NCT04575584|147182694|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6002|TWO_SIDED|95.0|0.55|2.82|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.82|0.55|0.6002
73816811|NCT04575584|147182694|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4733|TWO_SIDED|95.0|0.58|3.21|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.21|0.58|0.4733
73816812|NCT04575584|147182694|SUPERIORITY||Odds Ratio (OR)|0.82||||0.622|TWO_SIDED|95.0|0.38|1.78|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.78|0.38|0.6220
73816813|NCT04575584|147182695|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7871|TWO_SIDED|95.0|0.28|2.6|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.60|0.28|0.7871
73816814|NCT04575584|147182695|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9598|TWO_SIDED|95.0|0.31|3.06|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.06|0.31|0.9598
73816815|NCT04575584|147182695|SUPERIORITY||Odds Ratio (OR)|0.79||||0.667|TWO_SIDED|95.0|0.27|2.31|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.31|0.27|0.6670
73816816|NCT02085070|147182718|SUPERIORITY|A response of \> 10% of patients was defined as superior.|% response|29.7|||||TWO_SIDED|95.0|15.9|47.0||||||Each group was assessed individually. The primary goal of this study is to determine the efficacy of MK-3475 in patients with untreated brain metastases from NSCLC. The primary endpoint is the brain metastasis response rate (BMRR). A drug with minimal activity would be expected to have a BMRR of 10%.||47.0|15.9|
73816817|NCT02085070|147182718|SUPERIORITY|A response of \> 10% of patients was defined as superior.|% of patients|26.0|||||TWO_SIDED|95.0|10.0|48.0||||||Each group was assessed individually. The primary goal of this study is to determine the efficacy of MK-3475 in patients with untreated brain metastases from melanoma. The primary endpoint is the brain metastasis response rate (BMRR). A drug with minimal activity would be expected to have a BMRR of 10%.||48.0|10.0|
73816818|NCT02769312|147182720|OTHER||Effect size (cohen's d)|0.16||||0.46|TWO_SIDED||||||ANCOVA|||||||0.46
73816819|NCT02769312|147182721|SUPERIORITY||Effect size (cohen's d)|0.12||||0.61|TWO_SIDED||||||ANCOVA|||||||0.61
73816820|NCT02769312|147182722|SUPERIORITY||Effect size (cohen's d)|0.39||||0.04|TWO_SIDED||||||ANCOVA|||||||.04
73816821|NCT02815267|147182723|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|1.06||0.0083|TWO_SIDED|95.0|0.72|4.88|||ANCOVA|||Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, Baseline inflammatory lesion count and pooled investigational site as a blocking factor.||4.88|0.72|0.0083
73816822|NCT02815267|147182724|SUPERIORITY||Risk Difference (RD)|3.33|STANDARD_ERROR_OF_MEAN|2.48||0.1805|TWO_SIDED|95.0|-1.54|8.19||P-value is for the null hypothesis that the combined risk difference equals 0.|Cochran-Mantel-Haenszel|||||8.19|-1.54|0.1805
73816823|NCT02815267|147182725|SUPERIORITY|Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.|Mean Difference (Final Values)|12.73|STANDARD_ERROR_OF_MEAN|4.42||0.004|TWO_SIDED|95.0|4.07|21.39|||ANCOVA|||||21.39|4.07|0.0040
73816824|NCT02815267|147182726|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|1.03||0.0002|TWO_SIDED|95.0|1.85|5.87|||ANCOVA|||||5.87|1.85|0.0002
73816825|NCT02815267|147182726|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|2.38|6.4|||ANCOVA|||||6.40|2.38|<.0001
73816826|NCT02815267|147182727|SUPERIORITY|P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 6|Risk Difference (RD)|2.71|STANDARD_ERROR_OF_MEAN|1.32||0.0395|TWO_SIDED|95.0|0.13|5.3|||Cochran-Mantel-Haenszel|||||5.3|0.13|0.0395
73816827|NCT02815267|147182727|SUPERIORITY|P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 9.|Risk Difference (RD)|2.76|STANDARD_ERROR_OF_MEAN|1.55||0.0748|TWO_SIDED|95.0|-0.28|5.8|||Cochran-Mantel-Haenszel|||||5.80|-0.28|0.0748
73816828|NCT05600036|147182755|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||||||0.0025
73816829|NCT05600036|147182755|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
73816830|NCT05600036|147182755|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73816831|NCT05600036|147182755|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73816832|NCT05600036|147182755|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73816833|NCT01006590|147182765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.26|TWO_SIDED|95.0|-0.26|0.07|||ANCOVA|With baseline value as covariate and treatment group as factor; comparison of LSmeans for treatment||The null hypothesis H0: µt-µC=0, where μT denotes the mean absolute change in HbA1c from baseline to Week 24 in the group of patients treated with saxagliptin (test medication, T) and μC the mean absolute change in HbA1c from baseline to Week 24 in the group of patients with uptitration of metformin (comparator, C) A sample size of 120 randomized and treated patients per treatment group yielded 80% power under the assumption of a true treatment difference of 0.4% and a standard deviation of 1.1%||0.07|-0.26|0.26
73816834|NCT01006590|147182766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.8|STANDARD_ERROR_OF_MEAN|5.79||0.3202|TWO_SIDED|95.0|-5.6|17.1|||Regression, Logistic|||||17.1|-5.6|0.3202
73816835|NCT01006590|147182767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|4.58||0.6203|TWO_SIDED|95.0|-6.7|11.3|||Regression, Logistic|||||11.3|-6.7|0.6203
73816836|NCT01006590|147182768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.23||0.7627|TWO_SIDED|95.0|-0.38|0.52|||ANCOVA|||||0.52|-0.38|0.7627
73816837|NCT01006590|147182769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.19||0.7701|TWO_SIDED|95.0|-2.0|2.7|||ANCOVA|||||2.7|-2.0|0.7701
73816838|NCT01006590|147182770|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|4.34||0.5882|TWO_SIDED|95.0|-6.22|10.93|||ANCOVA|||||10.93|-6.22|0.5882
73816839|NCT00703118|147182809|SUPERIORITY_OR_OTHER||Difference in percentage of response|46.8|||<|0.001|TWO_SIDED|95.0|36.8|56.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.||56.7|36.8|<0.001
73816840|NCT00703118|147182809|SUPERIORITY_OR_OTHER||Difference in percentage of response|49.8|||<|0.001|TWO_SIDED|95.0|39.9|59.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48 or T12(DS)/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12(DS)/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.||59.7|39.9|<0.001
73816841|NCT01096680|147182822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||<|0.0001|TWO_SIDED|95.0|5.0|10.9|||Mixed Models Analysis|||||10.9|5.0|<0.0001
73816842|NCT01096680|147182822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.6|||<|0.0001|TWO_SIDED|95.0|10.2|15.0|||Mixed Models Analysis|||||15.0|10.2|<0.0001
73816843|NCT01096680|147182822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0|||<|0.0001|TWO_SIDED|95.0|11.7|16.2|||Mixed Models Analysis|||||16.2|11.7|<0.0001
73816844|NCT01096680|147182822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.3|||<|0.0001|TWO_SIDED|95.0|9.9|14.7|||Mixed Models Analysis|||||14.7|9.9|<0.0001
73816845|NCT01096680|147182822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3||||0.0014|TWO_SIDED|95.0|-6.9|-1.8|||Mixed Models Analysis|||||-1.8|-6.9|0.0014
73816846|NCT01096680|147182822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.7601|TWO_SIDED|95.0|-1.5|2.1|||Mixed Models Analysis|||||2.1|-1.5|0.7601
73816847|NCT01096680|147182822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.7||||0.0351|TWO_SIDED|95.0|0.1|3.2|||Mixed Models Analysis|||||3.2|0.1|0.0351
73816848|NCT01096680|147182823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1123|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||||0.1|-1.1|0.1123
73816849|NCT01096680|147182823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0002|TWO_SIDED|95.0|-1.8|-0.6|||Mixed Models Analysis|||||-0.6|-1.8|0.0002
73816850|NCT01096680|147182823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.0|||Mixed Models Analysis|||||-1.0|-2.2|<0.0001
73816851|NCT01096680|147182823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0947|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||||0.1|-1.1|0.0947
73816852|NCT01096680|147182823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9393|TWO_SIDED|95.0|-0.6|0.6|||Mixed Models Analysis|||||0.6|-0.6|0.9393
73816853|NCT01096680|147182823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0297|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis|||||-0.1|-1.3|0.0297
73816854|NCT01096680|147182823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0004|TWO_SIDED|95.0|-1.7|-0.5|||Mixed Models Analysis|||||-0.5|-1.7|0.0004
73816855|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.7758|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||7:50pm||0.6|-0.5|0.7758
73816856|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.1798|TWO_SIDED|95.0|-0.2|0.9|||Mixed Models Analysis|||7:50pm||0.9|-0.2|0.1798
73816857|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.609|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||7:50pm||0.7|-0.4|0.6090
73816858|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.1169|TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis|||7:50pm||1.0|-0.1|0.1169
73816859|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3028|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||7:50pm||0.3|-0.8|0.3028
73816860|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9831|TWO_SIDED|95.0|-0.5|0.5|||Mixed Models Analysis|||7:50pm||0.5|-0.5|0.9831
73816861|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2887|TWO_SIDED|95.0|-0.8|0.2|||Mixed Models Analysis|||7:50pm||0.2|-0.8|0.2887
73816862|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.4395|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.4395
73816863|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9019|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||8:50pm||0.6|-0.5|0.9019
73816864|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3419|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.3419
73816865|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9581|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm||0.5|-0.6|0.9581
73816866|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2572|TWO_SIDED|95.0|-0.9|0.2|||Mixed Models Analysis|||8:50pm||0.2|-0.9|0.2572
73816867|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8085|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm||0.5|-0.6|0.8085
73816868|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3678|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.3678
73816869|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3732|TWO_SIDED|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm||0.4|-0.9|0.3732
73816870|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.4924|TWO_SIDED|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm||0.4|-0.9|0.4924
73816871|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9798|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm||0.6|-0.7|0.9798
73816872|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.8557|TWO_SIDED|95.0|-0.6|0.7|||Mixed Models Analysis|||9:50pm||0.7|-0.6|0.8557
73816873|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0998|TWO_SIDED|95.0|-1.2|0.1|||Mixed Models Analysis|||9:50pm||0.1|-1.2|0.0998
73816874|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1479|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||9:50pm||0.2|-1.1|0.1479
73816875|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8358|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm||0.6|-0.7|0.8358
73816876|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0199|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis|||10:50pm||-0.1|-1.6|0.0199
73816877|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.7625|TWO_SIDED|95.0|-0.9|0.6|||Mixed Models Analysis|||10:50pm||0.6|-0.9|0.7625
73816878|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1936|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm||0.3|-1.2|0.1936
73816879|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.4534|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||10:50pm||1.0|-0.5|0.4534
73816880|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0012|TWO_SIDED|95.0|-2.0|-0.5|||Mixed Models Analysis|||10:50pm||-0.5|-2.0|0.0012
73816881|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.2072|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm||0.3|-1.2|0.2072
73816882|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0413|TWO_SIDED|95.0|-1.5|0.0|||Mixed Models Analysis|||10:50pm||0.0|-1.5|0.0413
73816883|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1086|TWO_SIDED|95.0|-1.5|0.1|||Mixed Models Analysis|||11:50pm||0.1|-1.5|0.1086
73816884|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.5843|TWO_SIDED|95.0|-1.0|0.6|||Mixed Models Analysis|||11:50pm||0.6|-1.0|0.5843
73816885|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0571|TWO_SIDED|95.0|-1.6|0.0|||Mixed Models Analysis|||11:50pm||0.0|-1.6|0.0571
73816886|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3965|TWO_SIDED|95.0|-1.2|0.5|||Mixed Models Analysis|||11:50pm||0.5|-1.2|0.3965
73816887|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0009|TWO_SIDED|95.0|-2.2|-0.6|||Mixed Models Analysis|||11:50pm||-0.6|-2.2|0.0009
73816888|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0211|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||11:50pm||-0.1|-1.8|0.0211
73816889|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.2863|TWO_SIDED|95.0|-1.2|0.4|||Mixed Models Analysis|||11:50pm||0.4|-1.2|0.2863
73816890|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0428|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||12:50am||0.0|-1.7|0.0428
73816891|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3757|TWO_SIDED|95.0|-0.5|1.2|||Mixed Models Analysis|||12:50am||1.2|-0.5|0.3757
73816892|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0002|TWO_SIDED|95.0|-2.4|-0.8|||Mixed Models Analysis|||12:50am||-0.8|-2.4|0.0002
73816893|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.3535|TWO_SIDED|95.0|-1.2|0.4|||Mixed Models Analysis|||12:50am||0.4|-1.2|0.3535
73816894|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.1|||Mixed Models Analysis|||12:50am||-1.1|-2.7|<0.0001
73816895|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1131|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|||12:50am||0.2|-1.5|0.1131
73816896|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0039|TWO_SIDED|95.0|-2.0|-0.4|||Mixed Models Analysis|||12:50am||-0.4|-2.0|0.0039
73816897|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1302|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|||1:50am||0.2|-1.5|0.1302
73816898|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.6138|TWO_SIDED|95.0|-0.6|1.1|||Mixed Models Analysis|||1:50am||1.1|-0.6|0.6138
73816899|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.0008|TWO_SIDED|95.0|-2.3|-0.6|||Mixed Models Analysis|||1:50am||-0.6|-2.3|0.0008
73816900|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.1643|TWO_SIDED|95.0|-1.5|0.3|||Mixed Models Analysis|||1:50am||0.3|-1.5|0.1643
73816901|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0002|TWO_SIDED|95.0|-2.5|-0.8|||Mixed Models Analysis|||1:50am||-0.8|-2.5|0.0002
73816902|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0782|TWO_SIDED|95.0|-1.6|0.1|||Mixed Models Analysis|||1:50am||0.1|-1.6|0.0782
73816903|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0441|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||1:50am||0.0|-1.7|0.0441
73816904|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0193|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am||-0.2|-2.2|0.0193
73816905|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7071|TWO_SIDED|95.0|-1.2|0.8|||Mixed Models Analysis|||2:50am||0.8|-1.2|0.7071
73816906|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0002|TWO_SIDED|95.0|-2.9|-0.9|||Mixed Models Analysis|||2:50am||-0.9|-2.9|0.0002
73816907|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0611|TWO_SIDED|95.0|-1.9|0.0|||Mixed Models Analysis|||2:50am||0.0|-1.9|0.0611
73816908|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.2|||Mixed Models Analysis|||2:50am||-1.2|-3.2|<0.0001
73816909|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.016|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am||-0.2|-2.2|0.0160
73816910|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.048|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||2:50am||0.0|-2.0|0.0480
73816911|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0234|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||3:50am||-0.2|-2.2|0.0234
73816912|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.5624|TWO_SIDED|95.0|-1.3|0.7|||Mixed Models Analysis|||3:50am||0.7|-1.3|0.5624
73816913|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Mixed Models Analysis|||3:50am||-1.5|-3.5|<0.0001
73816914|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0022|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|||3:50am||-0.6|-2.6|0.0022
73816915|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.7|-1.6|||Mixed Models Analysis|||3:50am||-1.6|-3.7|<0.0001
73816916|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.0008|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|||3:50am||-0.8|-2.8|0.0008
73816917|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0883|TWO_SIDED|95.0|-1.9|0.1|||Mixed Models Analysis|||3:50am||0.1|-1.9|0.0883
73816918|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.3093|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||4:50am||0.5|-1.5|0.3093
73816919|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.8871|TWO_SIDED|95.0|-0.9|1.1|||Mixed Models Analysis|||4:50am||1.1|-0.9|0.8871
73816920|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.2|||Mixed Models Analysis|||4:50am||-1.2|-3.2|<0.0001
73816921|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0022|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|||4:50am||-0.6|-2.6|0.0022
73816922|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.4|||Mixed Models Analysis|||4:50am||-1.4|-3.4|<0.0001
73816923|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.0006|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|||4:50am||-0.8|-2.8|0.0006
73816924|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.2462|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||4:50am||0.4|-1.6|0.2462
73816925|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.4427|TWO_SIDED|95.0|-1.4|0.6|||Mixed Models Analysis|||5:50am||0.6|-1.4|0.4427
73816926|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.4405|TWO_SIDED|95.0|-0.6|1.4|||Mixed Models Analysis|||5:50am||1.4|-0.6|0.4405
73816927|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.0003|TWO_SIDED|95.0|-3.0|-0.9|||Mixed Models Analysis|||5:50am||-0.9|-3.0|0.0003
73816928|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0279|TWO_SIDED|95.0|-2.2|-0.1|||Mixed Models Analysis|||5:50am||-0.1|-2.2|0.0279
73816929|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Mixed Models Analysis|||5:50am||-1.5|-3.5|<0.0001
73816930|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0015|TWO_SIDED|95.0|-2.7|-0.7|||Mixed Models Analysis|||5:50am||-0.7|-2.7|0.0015
73816931|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.1246|TWO_SIDED|95.0|-1.8|0.2|||Mixed Models Analysis|||5:50am||0.2|-1.8|0.1246
73816932|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.3067|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||6:50am||0.5|-1.6|0.3067
73816933|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.894|TWO_SIDED|95.0|-1.0|1.1|||Mixed Models Analysis|||6:50am||1.1|-1.0|0.8940
73816934|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0034|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||6:50am||-0.5|-2.7|0.0034
73816935|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0708|TWO_SIDED|95.0|-2.0|0.1|||Mixed Models Analysis|||6:50am||0.1|-2.0|0.0708
73816936|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||6:50am||-1.4|-3.6|<0.0001
73816937|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0006|TWO_SIDED|95.0|-2.9|-0.8|||Mixed Models Analysis|||6:50am||-0.8|-2.9|0.0006
73816938|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.2476|TWO_SIDED|95.0|-1.7|0.4|||Mixed Models Analysis|||6:50am||0.4|-1.7|0.2476
73816939|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.231|TWO_SIDED|95.0|-1.8|0.4|||Mixed Models Analysis|||7:50am||0.4|-1.8|0.2310
73816940|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8369|TWO_SIDED|95.0|-1.2|1.0|||Mixed Models Analysis|||7:50am||1.0|-1.2|0.8369
73816941|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0035|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||7:50am||-0.5|-2.7|0.0035
73816942|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0498|TWO_SIDED|95.0|-2.2|0.0|||Mixed Models Analysis|||7:50am||0.0|-2.2|0.0498
73816943|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||7:50am||-1.4|-3.6|<0.0001
73816944|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0007|TWO_SIDED|95.0|-3.0|-0.8|||Mixed Models Analysis|||7:50am||-0.8|-3.0|0.0007
73816945|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.3198|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||7:50am||0.5|-1.6|0.3198
73816946|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.375|TWO_SIDED|95.0|-0.6|1.7|||Mixed Models Analysis|||8:50am||1.7|-0.6|0.3750
73816947|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7978|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||8:50am||1.0|-1.3|0.7978
73816948|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.5197|TWO_SIDED|95.0|-1.5|0.8|||Mixed Models Analysis|||8:50am||0.8|-1.5|0.5197
73816949|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0751|TWO_SIDED|95.0|-2.2|0.1|||Mixed Models Analysis|||8:50am||0.1|-2.2|0.0751
73816950|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.1079|TWO_SIDED|95.0|-2.1|0.2|||Mixed Models Analysis|||8:50am||0.2|-2.1|0.1079
73816951|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0065|TWO_SIDED|95.0|-2.8|-0.5|||Mixed Models Analysis|||8:50am||-0.5|-2.8|0.0065
73816952|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.2529|TWO_SIDED|95.0|-0.5|1.8|||Mixed Models Analysis|||8:50am||1.8|-0.5|0.2529
73816953|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.6364|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am||0.8|-1.3|0.6364
73816954|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9417|TWO_SIDED|95.0|-1.1|1.0|||Mixed Models Analysis|||9:50am||1.0|-1.1|0.9417
73816955|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.02|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|||9:50am||-0.2|-2.3|0.0200
73816956|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0527|TWO_SIDED|95.0|-2.1|0.0|||Mixed Models Analysis|||9:50am||0.0|-2.1|0.0527
73816957|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0107|TWO_SIDED|95.0|-2.5|-0.3|||Mixed Models Analysis|||9:50am||-0.3|-2.5|0.0107
73816958|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0303|TWO_SIDED|95.0|-2.2|-0.1|||Mixed Models Analysis|||9:50am||-0.1|-2.2|0.0303
73816959|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.6889|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am||0.8|-1.3|0.6889
73816960|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9552|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|||10:50am||1.1|-1.2|0.9552
73816961|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.7558|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|||10:50am||1.3|-1.0|0.7558
73816962|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.1824|TWO_SIDED|95.0|-1.9|0.4|||Mixed Models Analysis|||10:50am||0.4|-1.9|0.1824
73816963|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.3323|TWO_SIDED|95.0|-1.7|0.6|||Mixed Models Analysis|||10:50am||0.6|-1.7|0.3323
73816964|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0413|TWO_SIDED|95.0|-2.4|0.0|||Mixed Models Analysis|||10:50am||0.0|-2.4|0.0413
73816965|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0925|TWO_SIDED|95.0|-2.2|0.2|||Mixed Models Analysis|||10:50am||0.2|-2.2|0.0925
73816966|NCT01096680|147182824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7133|TWO_SIDED|95.0|-1.4|0.9|||Mixed Models Analysis|||10:50am||0.9|-1.4|0.7133
73816967|NCT01096680|147182825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-36.6|-16.5|||Mixed Models Analysis|||||-16.5|-36.6|<0.0001
73816968|NCT01096680|147182825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.4|||<|0.0001|TWO_SIDED|95.0|-45.5|-25.4|||Mixed Models Analysis|||||-25.4|-45.5|<0.0001
73816969|NCT01096680|147182825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.7|||<|0.0001|TWO_SIDED|95.0|-36.7|-16.6|||Mixed Models Analysis|||||-16.6|-36.7|<0.0001
73816970|NCT01096680|147182825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-36.6|-16.5|||Mixed Models Analysis|||||-16.5|-36.6|<0.0001
73816971|NCT01096680|147182825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9945|TWO_SIDED|95.0|-10.1|10.0|||Mixed Models Analysis|||||10.0|-10.1|0.9945
73816972|NCT01096680|147182825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9||||0.0814|TWO_SIDED|95.0|-18.9|1.1|||Mixed Models Analysis|||||1.1|-18.9|0.0814
73816973|NCT01096680|147182825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.9743|TWO_SIDED|95.0|-10.2|9.9|||Mixed Models Analysis|||||9.9|-10.2|0.9743
73816974|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6||||0.0544|TWO_SIDED|95.0|-19.4|0.2|||Mixed Models Analysis|||9:15pm||0.2|-19.4|0.0544
73816975|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8||||0.441|TWO_SIDED|95.0|-13.6|6.0|||Mixed Models Analysis|||9:15pm||6.0|-13.6|0.4410
73816976|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1||||0.1046|TWO_SIDED|95.0|-17.9|1.7|||Mixed Models Analysis|||9:15pm||1.7|-17.9|0.1046
73816977|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.6467|TWO_SIDED|95.0|-12.0|7.5|||Mixed Models Analysis|||9:15pm||7.5|-12.0|0.6467
73816978|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4||||0.1971|TWO_SIDED|95.0|-16.2|3.4|||Mixed Models Analysis|||9:15pm||3.4|-16.2|0.1971
73816979|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.9052|TWO_SIDED|95.0|-10.4|9.2|||Mixed Models Analysis|||9:15pm||9.2|-10.4|0.9052
73816980|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8||||0.242|TWO_SIDED|95.0|-15.6|4.0|||Mixed Models Analysis|||9:15pm||4.0|-15.6|0.2420
73816981|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.7||||0.0001|TWO_SIDED|95.0|-25.1|-8.3|||Mixed Models Analysis|||11:15pm||-8.3|-25.1|0.0001
73816982|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3||||0.4321|TWO_SIDED|95.0|-5.0|11.6|||Mixed Models Analysis|||11:15pm||11.6|-5.0|0.4321
73816983|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.4|||<|0.0001|TWO_SIDED|95.0|-26.7|-10.1|||Mixed Models Analysis|||11:15pm||-10.1|-26.7|<0.0001
73816984|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.6999|TWO_SIDED|95.0|-6.7|9.9|||Mixed Models Analysis|||11:15pm||9.9|-6.7|0.6999
73816985|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.1|||<|0.0001|TWO_SIDED|95.0|-26.4|-9.8|||Mixed Models Analysis|||11:15pm||-9.8|-26.4|<0.0001
73816986|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9||||0.6566|TWO_SIDED|95.0|-6.4|10.2|||Mixed Models Analysis|||11:15pm||10.2|-6.4|0.6566
73816987|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|||<|0.0001|TWO_SIDED|95.0|-28.3|-11.7|||Mixed Models Analysis|||11:15pm||-11.7|-28.3|<0.0001
73816988|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.2|||<|0.0001|TWO_SIDED|95.0|-36.1|-14.3|||Mixed Models Analysis|||1:15am||-14.3|-36.1|<0.0001
73816989|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.7824|TWO_SIDED|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am||9.4|-12.4|0.7824
73816990|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.1|||<|0.0001|TWO_SIDED|95.0|-36.0|-14.3|||Mixed Models Analysis|||1:15am||-14.3|-36.0|<0.0001
73816991|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.7867|TWO_SIDED|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am||9.4|-12.4|0.7867
73816992|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-37.4|-15.6|||Mixed Models Analysis|||1:15am||-15.6|-37.4|<0.0001
73816993|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9||||0.6029|TWO_SIDED|95.0|-13.7|8.0|||Mixed Models Analysis|||1:15am||8.0|-13.7|0.6029
73816994|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.6|||<|0.0001|TWO_SIDED|95.0|-34.5|-12.8|||Mixed Models Analysis|||1:15am||-12.8|-34.5|<0.0001
73816995|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.1|||<|0.0001|TWO_SIDED|95.0|-50.1|-24.1|||Mixed Models Analysis|||3:15am||-24.1|-50.1|<0.0001
73816996|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.8684|TWO_SIDED|95.0|-11.9|14.1|||Mixed Models Analysis|||3:15am||14.1|-11.9|0.8684
73816997|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.3|||<|0.0001|TWO_SIDED|95.0|-66.3|-40.3|||Mixed Models Analysis|||3:15am||-40.3|-66.3|<0.0001
73816998|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.1||||0.0228|TWO_SIDED|95.0|-28.1|-2.1|||Mixed Models Analysis|||3:15am||-2.1|-28.1|0.0228
73816999|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.0|||<|0.0001|TWO_SIDED|95.0|-53.0|-27.0|||Mixed Models Analysis|||3:15am||-27.0|-53.0|<0.0001
73817000|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.7852|TWO_SIDED|95.0|-14.8|11.2|||Mixed Models Analysis|||3:15am||11.2|-14.8|0.7852
73817001|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.2|||<|0.0001|TWO_SIDED|95.0|-51.2|-25.2|||Mixed Models Analysis|||3:15am||-25.2|-51.2|<0.0001
73817002|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.2|||<|0.0001|TWO_SIDED|95.0|-51.3|-25.1|||Mixed Models Analysis|||5:15am||-25.1|-51.3|<0.0001
73817003|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.9||||0.5528|TWO_SIDED|95.0|-9.1|17.0|||Mixed Models Analysis|||5:15am||17.0|-9.1|0.5528
73817004|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.9|||<|0.0001|TWO_SIDED|95.0|-67.0|-40.9|||Mixed Models Analysis|||5:15am||-40.9|-67.0|<0.0001
73817005|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.8||||0.0747|TWO_SIDED|95.0|-24.9|1.2|||Mixed Models Analysis|||5:15am||1.2|-24.9|0.0747
73817006|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.2|||<|0.0001|TWO_SIDED|95.0|-62.2|-36.1|||Mixed Models Analysis|||5:15am||-36.1|-62.2|<0.0001
73817007|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1||||0.2868|TWO_SIDED|95.0|-20.1|6.0|||Mixed Models Analysis|||5:15am||6.0|-20.1|0.2868
73817008|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.1|||<|0.0001|TWO_SIDED|95.0|-55.2|-29.1|||Mixed Models Analysis|||5:15am||-29.1|-55.2|<0.0001
73817009|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.6||||0.0007|TWO_SIDED|95.0|-59.1|-16.2|||Mixed Models Analysis|||7:15am||-16.2|-59.1|0.0007
73817010|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.9089|TWO_SIDED|95.0|-22.7|20.2|||Mixed Models Analysis|||7:15am||20.2|-22.7|0.9089
73817011|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.9|||<|0.0001|TWO_SIDED|95.0|-74.3|-31.4|||Mixed Models Analysis|||7:15am||-31.4|-74.3|<0.0001
73817012|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5||||0.1307|TWO_SIDED|95.0|-37.9|5.0|||Mixed Models Analysis|||7:15am||5.0|-37.9|0.1307
73817013|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.3||||0.0011|TWO_SIDED|95.0|-57.7|-14.8|||Mixed Models Analysis|||7:15am||-14.8|-57.7|0.0011
73817014|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9903|TWO_SIDED|95.0|-21.3|21.6|||Mixed Models Analysis|||7:15am||21.6|-21.3|0.9903
73817015|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.4||||0.001|TWO_SIDED|95.0|-57.8|-14.9|||Mixed Models Analysis|||7:15am||-14.9|-57.8|0.0010
73817016|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.4||||0.1655|TWO_SIDED|95.0|-51.7|9.0|||Mixed Models Analysis|||9:15am||9.0|-51.7|0.1655
73817017|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.8975|TWO_SIDED|95.0|-32.4|28.5|||Mixed Models Analysis|||9:15am||28.5|-32.4|0.8975
73817018|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.2||||0.0199|TWO_SIDED|95.0|-66.5|-5.8|||Mixed Models Analysis|||9:15am||-5.8|-66.5|0.0199
73817019|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.8||||0.2785|TWO_SIDED|95.0|-47.2|13.7|||Mixed Models Analysis|||9:15am||13.7|-47.2|0.2785
73817020|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3||||0.5048|TWO_SIDED|95.0|-40.6|20.1|||Mixed Models Analysis|||9:15am||20.1|-40.6|0.5048
73817021|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1||||0.5533|TWO_SIDED|95.0|-21.3|39.6|||Mixed Models Analysis|||9:15am||39.6|-21.3|0.5533
73817022|NCT01096680|147182826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.4||||0.2098|TWO_SIDED|95.0|-49.9|11.1|||Mixed Models Analysis|||9:15am||11.1|-49.9|0.2098
73817023|NCT02033200|147182838|SUPERIORITY_OR_OTHER||LS mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.335||0.8216|TWO_SIDED|95.0|-0.592|0.744|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.744|-0.592|0.8216
73817024|NCT02033200|147182838|SUPERIORITY_OR_OTHER||LS means difference|0.257|STANDARD_ERROR_OF_MEAN|0.258||0.324|TWO_SIDED|95.0|-0.258|0.771|||ANCOVA|||The sample size had adequate power to detect a meaningful difference between treatment groups in the left eye.||0.771|-0.258|0.324
73817025|NCT02033200|147182839|SUPERIORITY_OR_OTHER||LS means difference|0.004|STANDARD_ERROR_OF_MEAN|0.014||0.7864|TWO_SIDED|95.0|-0.024|0.031|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.||0.031|-0.024|0.7864
73817026|NCT02033200|147182839|SUPERIORITY_OR_OTHER||LS Means difference|-0.022|STANDARD_ERROR_OF_MEAN|0.017||0.1953|TWO_SIDED|95.0|-0.056|0.012|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.||0.012|-0.056|0.1953
73817027|NCT02033200|147182840|SUPERIORITY_OR_OTHER||LS means difference|-0.16|STANDARD_ERROR_OF_MEAN|0.061||0.0101|TWO_SIDED|95.0|-0.28|-0.039|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.||-0.039|-0.280|0.0101
73817028|NCT02033200|147182840|SUPERIORITY_OR_OTHER||LS means difference|-0.087|STANDARD_ERROR_OF_MEAN|0.061||0.1583|TWO_SIDED|95.0|-0.209|0.035|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.||0.035|-0.209|0.1583
73817029|NCT02033200|147182841|SUPERIORITY_OR_OTHER||LS means difference|-0.031|STANDARD_ERROR_OF_MEAN|0.359||0.9324|TWO_SIDED|95.0|-0.746|0.685|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in Intraocular Pressure between the two treatment groups in the right eye.||0.685|-0.746|0.9324
73817030|NCT02033200|147182841|SUPERIORITY_OR_OTHER||LS means difference|0.751|STANDARD_ERROR_OF_MEAN|0.348||0.0343|TWO_SIDED|95.0|0.057|1.44|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in intraocular pressure between the two treatment groups in the left eye.||1.44|0.057|0.0343
73817031|NCT02033200|147182842|SUPERIORITY_OR_OTHER||LS Means difference|0.017|STANDARD_ERROR_OF_MEAN|0.017||0.3139|TWO_SIDED|95.0|-0.017|0.051|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.051|-0.017|0.3139
73817032|NCT02033200|147182842|SUPERIORITY_OR_OTHER||LS means difference|-0.002|STANDARD_ERROR_OF_MEAN|0.022||0.9334|TWO_SIDED|95.0|-0.045|0.042|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.042|-0.045|0.9334
73817033|NCT02033200|147182843|SUPERIORITY_OR_OTHER||LS means difference|0.016|STANDARD_ERROR_OF_MEAN|0.055||0.7723|TWO_SIDED|95.0|-0.093|0.125|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.125|-0.093|0.7723
73817034|NCT02033200|147182843|SUPERIORITY_OR_OTHER||LS means difference|0.007|STANDARD_ERROR_OF_MEAN|0.058||0.9107|TWO_SIDED|95.0|-0.109|0.122|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.122|-0.109|0.9107
73817035|NCT02033200|147182844|SUPERIORITY_OR_OTHER||LS Means difference|-0.078|STANDARD_ERROR_OF_MEAN|0.278||0.7787|TWO_SIDED|95.0|-0.632|0.475|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.475|-0.632|0.7787
73817036|NCT02033200|147182844|SUPERIORITY_OR_OTHER||LS means difference|-0.18|STANDARD_ERROR_OF_MEAN|0.344||0.6013|TWO_SIDED|95.0|-0.865|0.504|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.504|-0.865|0.6013
73817037|NCT02033200|147182845|SUPERIORITY_OR_OTHER||LS means difference|0.091|STANDARD_ERROR_OF_MEAN|0.4||0.8209|TWO_SIDED|95.0|-0.705|0.887|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the right eye.||0.887|-0.705|0.8209
73817038|NCT02033200|147182845|SUPERIORITY_OR_OTHER||LS means difference|0.227|STANDARD_ERROR_OF_MEAN|0.33||0.4931|TWO_SIDED|95.0|-0.43|0.884|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the left eye.||0.884|-0.430|0.4931
73817039|NCT00808470|147182861|SUPERIORITY_OR_OTHER|||||||0.58|||||||t-test, 2 sided|||15 minutes after exposure||||0.58
73817040|NCT00808470|147182861|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||1 hour and 15 minutes after exposure||||0.39
73817041|NCT00808470|147182861|SUPERIORITY_OR_OTHER|||||||0.51|||||||t-test, 2 sided|||2 Hours 15 minutes after exposure||||.51
73817042|NCT00808470|147182861|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||3 hours, 15 minutes after exposure||||.36
73817043|NCT00808470|147182861|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||1 day after exposure||||.86
73817044|NCT00808470|147182861|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||1 week after exposure||||.24
73817045|NCT01945294|147182895|SUPERIORITY_OR_OTHER||Difference in SVR12 percentage|-11.4|||||TWO_SIDED|95.0|-23.2|0.4||||||||0.4|-23.2|
73817046|NCT02494401|147182905|SUPERIORITY|||||||0.87||||||p value of baseline comparison.|Wilcoxon (Mann-Whitney)|||||||0.87
73817047|NCT02494401|147182905|SUPERIORITY|||||||0.32||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.32
73817048|NCT02494401|147182905|SUPERIORITY|||||||0.3||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.3
73817049|NCT02494401|147182906|SUPERIORITY|||||||0.08||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.08
73817050|NCT02494401|147182906|SUPERIORITY|||||||0.05||||||p value 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.05
73817051|NCT02494401|147182906|SUPERIORITY|||||||0.008||||||p value 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.008
73817052|NCT02494401|147182907|SUPERIORITY|||||||0.68||||||p value baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.68
73817053|NCT02494401|147182907|SUPERIORITY|||||||0.83||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.83
73817054|NCT02494401|147182907|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
73817055|NCT02494401|147182908|SUPERIORITY|||||||0.96||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.96
73817056|NCT02494401|147182908|SUPERIORITY|||||||0.69||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.69
73817057|NCT02494401|147182908|SUPERIORITY|||||||0.6||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.6
73817058|NCT02494401|147182909|SUPERIORITY|||||||0.89||||||p value baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.89
73817059|NCT02494401|147182909|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
73817060|NCT02494401|147182909|SUPERIORITY|||||||0.56||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.56
73817061|NCT02494401|147182910|SUPERIORITY|||||||0.69||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.69
73817062|NCT02494401|147182910|SUPERIORITY|||||||0.29||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.29
73817063|NCT02494401|147182910|SUPERIORITY|||||||0.07||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.07
73817064|NCT02494401|147182911|SUPERIORITY|||||||0.28||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.28
73817065|NCT02494401|147182911|SUPERIORITY|||||||0.16||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.16
73817066|NCT02494401|147182911|SUPERIORITY|||||||0.23||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.23
73817067|NCT02494401|147182912|SUPERIORITY|||||||0.93||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.93
73817068|NCT02494401|147182912|SUPERIORITY|||||||0.54||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.54
73817069|NCT02494401|147182912|SUPERIORITY|||||||0.33||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.33
73817070|NCT02494401|147182913|SUPERIORITY|||||||0.59||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.59
73817071|NCT02494401|147182913|SUPERIORITY|||||||0.25||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.25
73817072|NCT02494401|147182913|SUPERIORITY|||||||0.12||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.12
73817073|NCT02494401|147182914|SUPERIORITY|||||||0.51||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.51
73817074|NCT02494401|147182914|SUPERIORITY|||||||0.93||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.93
73817075|NCT02494401|147182914|SUPERIORITY|||||||0.84||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.84
73817076|NCT02494401|147182915|SUPERIORITY|||||||0.83||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.83
73817077|NCT02494401|147182915|SUPERIORITY|||||||0.27||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.27
73817078|NCT02494401|147182915|SUPERIORITY|||||||0.18||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.18
73817079|NCT02494401|147182916|SUPERIORITY|||||||0.64||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.64
73817080|NCT02494401|147182916|SUPERIORITY|||||||0.8||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.8
73817081|NCT02494401|147182916|SUPERIORITY|||||||0.09||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.09
73817082|NCT02494401|147182917|SUPERIORITY|||||||0.73||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.73
73817083|NCT02494401|147182917|SUPERIORITY|||||||0.82||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.82
73817084|NCT02494401|147182917|SUPERIORITY|||||||0.04||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.04
73817085|NCT02494401|147182918|SUPERIORITY|||||||0.95||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.95
73817086|NCT02494401|147182918|SUPERIORITY|||||||0.87||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.87
73817087|NCT02494401|147182918|SUPERIORITY|||||||0.63||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.63
73817088|NCT02494401|147182919|SUPERIORITY|||||||0.05||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.05
73817089|NCT02494401|147182919|SUPERIORITY|||||||0.62||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.62
73817090|NCT02494401|147182919|SUPERIORITY|||||||0.7||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.7
73817091|NCT02494401|147182920|SUPERIORITY|||||||0.29||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.29
73817092|NCT02494401|147182920|SUPERIORITY|||||||0.58||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.58
73817093|NCT02494401|147182920|SUPERIORITY|||||||0.49||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.49
73817094|NCT02494401|147182921|SUPERIORITY|||||||0.87||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.87
73817095|NCT02494401|147182921|SUPERIORITY|||||||0.89||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.89
73817096|NCT02494401|147182921|SUPERIORITY|||||||0.82||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.82
73817097|NCT00410072|147182944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||0.0882|TWO_SIDED|95.0|-1.0|14.9|||Cochran-Mantel-Haenszel|||Week 96||14.9|-1.0|0.0882
73817098|NCT00410072|147182945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.5|||||TWO_SIDED|95.0|2.3|24.8|||NC=F|||||24.8|2.3|
73817099|NCT00410072|147182945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-7.7|12.0|||NC=F|||||12.0|-7.7|
73817100|NCT00410072|147182945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.6||||0.046|TWO_SIDED|95.0|0.2|21.0|||Cochran-Mantel-Haenszel|||||21.0|0.2|0.0460
73817101|NCT00410072|147182945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-12.0|9.5|||NC=F|||||9.5|-12.0|
73817102|NCT00410072|147182946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-1.8|16.0|||NC=F|||Analysis at week 48. The stratified analysis was based on HBeAg strata at randomization.||16.0|-1.8|
73817103|NCT00410072|147182946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-1.1|15.2|||NC=F|||Analysis at week 96. The stratified analysis was based on HBeAg strata at randomization.||15.2|-1.1|
73817104|NCT00410072|147182947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-1.5|17.1|||NC=F|||Analysis at Week 48. The stratified analysis was based on HBeAg strata at randomization.||17.1|-1.5|
73817105|NCT00410072|147182947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|||||TWO_SIDED|95.0|-0.2|17.3|||NC=F|||Analysis at Week 96. The stratified analysis was based on HBeAg strata at randomization.||17.3|-0.2|
73817106|NCT00410072|147182949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||||TWO_SIDED|95.0|-18.8|-2.0|||NC+F|||Analysis at Week 48. The stratified analysis is based on HBeAg strata at randomization.||-2.0|-18.8|
73817107|NCT00410072|147182949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-21.5|-4.1|||NC=F|||Analysis at Week 96. The stratified analysis is based on HBeAg strata at randomization.||-4.1|-21.5|
73817108|NCT00410072|147182950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|||||TWO_SIDED|95.0|-15.9|4.2|||NC=F|||Analysis at Week 48||4.2|-15.9|
73817109|NCT00410072|147182950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0|-20.6|2.3|||NC=F|||Analysis at Week 96||2.3|-20.6|
73817110|NCT00410072|147182951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|||||TWO_SIDED|95.0|-13.8|5.6|||NC=F|||Analysis at Week 48||5.6|-13.8|
73817111|NCT00410072|147182951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||||TWO_SIDED|95.0|-21.5|-0.1|||NC=F|||Analysis at Week 96||-0.1|-21.5|
73817112|NCT00410072|147182952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||||TWO_SIDED|95.0|-5.3|1.9|||NC=F|||Analysis at Week 48||1.9|-5.3|
73817113|NCT00410072|147182952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-3.9|6.1|||NC=F|||Analysis at Week 96||6.1|-3.9|
73817114|NCT00410072|147182953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.2|2.0|||NC=F|||Analysis at Week 48||2.0|-2.2|
73817115|NCT00410072|147182953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.3|4.9|||NC=F|||Analysis at Week 96||4.9|-2.3|
73817116|NCT00904917|147182964|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||||||.015
73817117|NCT00904917|147182966|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Linear|||||||.037
73817118|NCT02771860|147182977|SUPERIORITY||Mean Difference (Final Values)|8.9||||0.024|TWO_SIDED|95.0|1.0|16.9|||GEE|||Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.||16.9|1.0|0.024
73817119|NCT02771860|147182978|SUPERIORITY||Odds Ratio (OR)|0.23|||<|0.001|TWO_SIDED|95.0|0.11|0.5|||Regression, Logistic|||||0.50|0.11|<0.001
73817120|NCT02771860|147182979|SUPERIORITY||Mean Difference (Final Values)|14.3||||0.003|TWO_SIDED|95.0|4.6|24.0|||GEE|||Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.||24.0|4.6|0.003
73817121|NCT05025332|147183023|OTHER|||||||0.0039|||||||Wilcoxon Signed rank|null median = 4, not 0||Descriptive statistics were used to summarize the data. For total scores, waterfall plots and histograms/bar charts were created at the EOT visit with plots for all participants.||||.0039
73817122|NCT05025332|147183024|OTHER|||||||0.0234|||||||Wilcoxon Signed rank|null median = 4, not 0||Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants.||||0.0234
73817123|NCT05025332|147183025|OTHER|Change from baseline||||||0.0313|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.0313
73817124|NCT05025332|147183026|OTHER|Change from baseline||||||0.0039|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.0039
73817125|NCT05025332|147183027|OTHER|change from baseline||||||0.1934|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.1934
73817126|NCT05025332|147183028|OTHER|Change from baseline||||||0.748|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7480
73817127|NCT05025332|147183029|OTHER|Change from baseline||||||0.3203|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3203
73817128|NCT05025332|147183030|OTHER|change from baseline||||||0.3574|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3574
73817129|NCT05025332|147183031|OTHER|Change from baseline||||||0.4131|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.4131
73817130|NCT05025332|147183032|OTHER|change from baseline||||||0.9063|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.9063
73817131|NCT05025332|147183033|OTHER|Change from baseline||||||1|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||1.00
73817132|NCT05025332|147183034|OTHER|Change from baseline||||||0.7002|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7002
73817133|NCT05025332|147183035|OTHER|Change from baseline||||||0.375|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3750
73817134|NCT05025332|147183036|OTHER|||||||0.7695|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7695
73817135|NCT05025332|147183037|OTHER|||||||0.2402|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.2402
73817136|NCT02634801|147183061|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|4.08|||<|0.0001|TWO_SIDED|95.0|2.46|6.77|||Fisher Exact|||||6.77|2.46|<.0001
73817137|NCT02634801|147183061|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.29||||0.0137|TWO_SIDED|95.0|1.06|1.56|||Fisher Exact|||||1.56|1.06|0.0137
73817138|NCT03539484|147183099|OTHER|A Bayesian approach is used to estimate the maximum tolerated dose (MTD).|Posterior probability at dose 1.8 mg|10.6|||||TWO_SIDED|95.0|2.1|26.5||There is no p-value derived; logistic regression is used to estimate the probability of DLT.|Regression, Logistic|||||26.5|2.10|
73817139|NCT06010732|147183150|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.986|TWO_SIDED|95.0|-5.5|5.4||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||5.4|-5.5|0.986
73896509|NCT00913458|147326250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.9338|TWO_SIDED|95.0|-10.0|10.9|||ANCOVA||Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.|Change from Week 52 to Week 91. The hyothesis of primary interest was the superiority of E25+MTX compared with PBO.||10.9|-10.0|0.9338
73817140|NCT06010732|147183150|SUPERIORITY||Mean Difference (Final Values)|27.2|||<|0.001|TWO_SIDED|95.0|21.7|32.6||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||32.6|21.7|<0.001
73817141|NCT06010732|147183150|SUPERIORITY||Mean Difference (Final Values)|27.2|||<|0.001|TWO_SIDED|95.0|21.7|32.7||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||32.7|21.7|<0.001
73817142|NCT06010732|147183151|SUPERIORITY||Ratio of Means|1.11||||0.23|TWO_SIDED|95.0|0.93|1.32||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(EFU)||1.32|0.93|0.230
73817143|NCT06010732|147183151|SUPERIORITY||Ratio of Means|5.77|||<|0.001|TWO_SIDED|95.0|4.86|6.85||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(EFU)||6.85|4.86|<0.001
73817144|NCT06010732|147183151|SUPERIORITY||Ratio of Means|5.2|||<|0.001|TWO_SIDED|95.0|4.37|6.18||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(EFU)||6.18|4.37|<0.001
73817145|NCT06010732|147183152|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.272|TWO_SIDED|95.0|-2.5|8.6||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|||8.6|-2.5|0.272
73817146|NCT06010732|147183152|SUPERIORITY||Mean Difference (Final Values)|34.8|||<|0.001|TWO_SIDED|95.0|29.3|40.3||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|||40.3|29.3|<0.001
73817147|NCT06010732|147183152|SUPERIORITY||Mean Difference (Final Values)|31.7|||<|0.001|TWO_SIDED|95.0|26.2|37.3||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|||37.3|26.2|<0.001
73817148|NCT06010732|147183153|SUPERIORITY||Ratio of Means|1.11||||0.191|TWO_SIDED|95.0|0.93|1.32||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(%CAR+100)||1.32|0.93|0.191
73817149|NCT06010732|147183153|SUPERIORITY||Ratio of Means|0.94||||0.003|TWO_SIDED|95.0|0.91|0.98||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(%CAR+100)||0.98|0.91|0.003
73817150|NCT06010732|147183153|SUPERIORITY||Ratio of Means|0.97||||0.092|TWO_SIDED|95.0|0.93|1.01||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(%CAR+100)||1.01|0.93|0.092
73817151|NCT06010732|147183154|SUPERIORITY||Ratio of Means|1.01||||0.905|TWO_SIDED|95.0|0.9|1.13||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(∆Z)||1.13|0.90|0.905
73817152|NCT06010732|147183154|SUPERIORITY||Ratio of Means|0.71|||<|0.001|TWO_SIDED|95.0|0.63|0.8||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(∆Z)||0.80|0.63|<0.001
73817153|NCT06010732|147183154|SUPERIORITY||Ratio of Means|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.79||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(∆Z)||0.79|0.63|<0.001
73817154|NCT06010732|147183155|SUPERIORITY||Ratio of Means|0.98||||0.721|TWO_SIDED|95.0|0.88|1.09||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(lesion depth)||1.09|0.88|0.721
73817155|NCT06010732|147183155|SUPERIORITY||Ratio of Means|0.75|||<|0.001|TWO_SIDED|95.0|0.68|0.84||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(lesion depth)||0.84|0.68|<0.001
73817156|NCT06010732|147183155|SUPERIORITY||Ratio of Means|0.77|||<|0.001|TWO_SIDED|95.0|0.69|0.86||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(lesion depth)||0.86|0.69|<0.001
73817157|NCT06010732|147183156|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.647|TWO_SIDED|95.0|-2.95|1.84||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|||1.84|-2.95|0.647
73817158|NCT06010732|147183156|SUPERIORITY||Mean Difference (Final Values)|6.35|||<|0.001|TWO_SIDED|95.0|3.95|8.75||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|||8.75|3.95|<0.001
73817159|NCT06010732|147183156|SUPERIORITY||Mean Difference (Final Values)|6.9|||<|0.001|TWO_SIDED|95.0|4.49|9.31||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|||9.31|4.49|<0.001
73817160|NCT04401202|147183157|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
73817161|NCT01119846|147183260|SUPERIORITY_OR_OTHER||Slope|0.5782|||||TWO_SIDED|90.0|0.523|0.6335|||||Dose Proportionality for GSK1292263 Using the Power Model.|||0.6335|0.5230|
73817162|NCT01119846|147183262|SUPERIORITY_OR_OTHER||Slope|0.5828|||||TWO_SIDED|90.0|0.5282|0.6375|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-24.|||0.6375|0.5282|
73817163|NCT01119846|147183262|SUPERIORITY_OR_OTHER||Slope|0.5808|||||TWO_SIDED|90.0|0.5325|0.6291|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-last.|||0.6291|0.5325|
73817164|NCT01119846|147183277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.036|||||TWO_SIDED|95.0|-1.17|1.1||||||||1.10|-1.17|
73817165|NCT01119846|147183277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.225|||||TWO_SIDED|95.0|-0.9|1.35||||||||1.35|-0.90|
73817166|NCT01119846|147183277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|||||TWO_SIDED|95.0|-1.1|1.19||||||||1.19|-1.10|
73817167|NCT01119846|147183277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.679|||||TWO_SIDED|95.0|-1.8|0.45||||||||0.45|-1.80|
73817168|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|||||TWO_SIDED|95.0|-1.8|2.33|||||Comparison of AUC(0-24)|||2.33|-1.80|
73817169|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.614|||||TWO_SIDED|95.0|-1.53|2.76|||||Comparison of AUC(0-24)|||2.76|-1.53|
73817170|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.451|||||TWO_SIDED|95.0|-1.64|2.54|||||Comparison of AUC(0-24)|||2.54|-1.64|
73817171|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.469|||||TWO_SIDED|95.0|-1.39|2.33|||||Comparison of AUC(0-24)|||2.33|-1.39|
73817172|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-2.53|1.95|||||Comparison of AUC(0-13)|||1.95|-2.53|
73817173|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|||||TWO_SIDED|95.0|-2.35|2.3|||||Comparison of AUC(0-13)|||2.30|-2.35|
73817174|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.163|||||TWO_SIDED|95.0|-2.48|2.15|||||Comparison of AUC(0-13)|||2.15|-2.48|
73817175|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|||||TWO_SIDED|95.0|-1.88|2.21|||||Comparison of AUC(0-13)|||2.21|-1.88|
73817176|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|||||TWO_SIDED|95.0|-1.58|0.87|||||Comparison of iAUC(0-13)|||0.87|-1.58|
73817177|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.136|||||TWO_SIDED|95.0|-1.41|1.13|||||Comparison of iAUC(0-13)|||1.13|-1.41|
73817178|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.091|||||TWO_SIDED|95.0|-1.36|1.18|||||Comparison of iAUC(0-13)|||1.18|-1.36|
73817179|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.206|||||TWO_SIDED|95.0|-1.33|0.91|||||Comparison of iAUC(0-13)|||0.91|-1.33|
73817180|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.499|||||TWO_SIDED|95.0|-1.68|0.68|||||Comparison of iAUC(0-24)|||0.68|-1.68|
73817181|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|||||TWO_SIDED|95.0|-1.24|1.21|||||Comparison of iAUC(0-24)|||1.21|-1.24|
73817182|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|||||TWO_SIDED|95.0|-1.44|0.95|||||Comparison of iAUC(0-24)|||0.95|-1.44|
73817183|NCT01119846|147183278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.661|||||TWO_SIDED|95.0|-1.72|0.4|||||Comparison of iAUC(0-24)|||0.40|-1.72|
73817184|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.898|||||TWO_SIDED|95.0|-479.74|379.94|||||Comparison of C-peptide, AUC 0-12|||379.94|-479.74|
73817185|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.642|||||TWO_SIDED|95.0|-507.32|384.04|||||Comparison of C-peptide, AUC 0-12|||384.04|-507.32|
73817186|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-85.849|||||TWO_SIDED|95.0|-530.07|358.37|||||Comparison of C-peptide, AUC 0-12|||358.37|-530.07|
73817187|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.422|||||TWO_SIDED|95.0|-494.09|291.25|||||Comparison of C-peptide, AUC 0-12|||291.25|-494.09|
73817188|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.239|||||TWO_SIDED|95.0|-340.32|261.85|||||Comparison of C-peptide, iAUC 0-12|||261.85|-340.32|
73817189|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-117.435|||||TWO_SIDED|95.0|-429.61|194.74|||||Comparison of C-peptide, iAUC 0-12|||194.74|-429.61|
73817190|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-121.982|||||TWO_SIDED|95.0|-433.14|189.18|||||Comparison of C-peptide, iAUC 0-12|||189.18|-433.14|
73817191|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-81.016|||||TWO_SIDED|95.0|-356.07|194.03|||||Comparison of C-peptide, iAUC 0-12|||194.03|-356.07|
73817192|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.812|||||TWO_SIDED|95.0|-8.08|13.7|||||Comparison of GIP total, AUC 0-12|||13.70|-8.08|
73817193|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.023|||||TWO_SIDED|95.0|-8.27|14.32|||||Comparison of GIP total, AUC 0-12|||14.32|-8.27|
73817194|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.483|||||TWO_SIDED|95.0|0.23|22.74|||||Comparison of GIP total, AUC 0-12|||22.74|0.23|
73817195|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.093|||||TWO_SIDED|95.0|-17.04|2.86|||||Comparison of GIP total, AUC 0-12|||2.86|-17.04|
73817196|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-7.28|12.28|||||Comparison of GIP total, iAUC 0-12|||12.28|-7.28|
73817197|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.526|||||TWO_SIDED|95.0|-6.61|13.67|||||Comparison of GIP total, iAUC 0-12|||13.67|-6.61|
73817198|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.934|||||TWO_SIDED|95.0|-2.17|18.04|||||Comparison of GIP total, iAUC 0-12|||18.04|-2.17|
73817199|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.055|||||TWO_SIDED|95.0|-15.99|1.88|||||Comparison of GIP total, iAUC 0-12|||1.88|-15.99|
73817200|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|||||TWO_SIDED|95.0|-0.79|0.76|||||Comparison of GLP-1 active, AUC 0-12|||0.76|-0.79|
73817201|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|||||TWO_SIDED|95.0|-0.78|0.82|||||Comparison of GLP-1 active, AUC 0-12|||0.82|-0.78|
73817202|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||||TWO_SIDED|95.0|-0.78|0.85|||||Comparison of GLP-1 active, AUC 0-12|||0.85|-0.78|
73817203|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.454|||||TWO_SIDED|95.0|2.74|4.17|||||Comparison of GLP-1 active, AUC 0-12|||4.17|2.74|
73817204|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.78|0.75|||||Comparison of GLP-1 active, iAUC 0-12|||0.75|-0.78|
73817205|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|||||TWO_SIDED|95.0|-0.79|0.8|||||Comparison of GLP-1 active, iAUC 0-12|||0.80|-0.79|
73817206|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|||||TWO_SIDED|95.0|-0.79|0.83|||||Comparison of GLP-1 active, iAUC 0-12|||0.83|-0.79|
73817207|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.399|||||TWO_SIDED|95.0|2.69|4.11|||||Comparison of GLP-1 active, iAUC 0-12|||4.11|2.69|
73817208|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|||||TWO_SIDED|95.0|-2.06|2.17|||||Comparison of GLP-1 total, AUC 0-12|||2.17|-2.06|
73817209|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|||||TWO_SIDED|95.0|-1.97|2.42|||||Comparison of GLP-1 total, AUC 0-12|||2.42|-1.97|
73817210|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.835|||||TWO_SIDED|95.0|-0.35|4.02|||||Comparison of GLP-1 total, AUC 0-12|||4.02|-0.35|
73817211|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.629|||||TWO_SIDED|95.0|-3.56|0.3|||||Comparison of GLP-1 total, AUC 0-12|||0.30|-3.56|
73817212|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|||||TWO_SIDED|95.0|-1.7|1.86|||||Comparison of GLP-1 total, iAUC 0-12|||1.86|-1.70|
73817213|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|||||TWO_SIDED|95.0|-1.56|2.13|||||Comparison of GLP-1 total, iAUC 0-12|||2.13|-1.56|
73817214|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764|||||TWO_SIDED|95.0|-1.08|2.6|||||Comparison of GLP-1 total, iAUC 0-12|||2.60|-1.08|
73817215|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.336|||||TWO_SIDED|95.0|-2.96|0.29|||||Comparison of GLP-1 total, iAUC 0-12|||0.29|-2.96|
73817216|NCT01119846|147183279|SUPERIORITY||Mean Difference (Final Values)|0.962|||||TWO_SIDED|95.0|-4.26|6.18|||||Comparison of Glucagon, AUC 0-12|||6.18|-4.26|
73817217|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.067|||||TWO_SIDED|95.0|-2.56|8.69|||||Comparison of Glucagon, AUC 0-12|||8.69|-2.56|
73817218|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.517|||||TWO_SIDED|95.0|-2.98|8.01|||||Comparison of Glucagon, AUC 0-12|||8.01|-2.98|
73817219|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.714|||||TWO_SIDED|95.0|-5.56|4.13|||||Comparison of Glucagon, AUC 0-12|||4.13|-5.56|
73817220|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.866|||||TWO_SIDED|95.0|-6.4|0.67|||||Comparison of Glucagon, iAUC 0-12|||0.67|-6.40|
73817221|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.865|||||TWO_SIDED|95.0|-4.68|2.95|||||Comparison of Glucagon, iAUC 0-12|||2.95|-4.68|
73817222|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.436|||||TWO_SIDED|95.0|-4.16|3.29|||||Comparison of Glucagon, iAUC 0-12|||3.29|-4.16|
73817223|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.573|||||TWO_SIDED|95.0|-4.86|1.71|||||Comparison of Glucagon, iAUC 0-12|||1.71|-4.86|
73817224|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.74|||||TWO_SIDED|95.0|-168.38|118.9|||||Comparison of Insulin, AUC 0-13|||118.90|-168.38|
73817225|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.229|||||TWO_SIDED|95.0|-161.16|136.7|||||Comparison of Insulin, AUC 0-13|||136.70|-161.16|
73817226|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.628|||||TWO_SIDED|95.0|-158.07|138.81|||||Comparison of Insulin, AUC 0-13|||138.81|-158.07|
73817227|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.936|||||TWO_SIDED|95.0|-198.15|64.28|||||Comparison of Insulin, AUC 0-13|||64.28|-198.15|
73817228|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.042|||||TWO_SIDED|95.0|-150.57|78.48|||||Comparison of Insulin, iAUC 0-13|||78.48|-150.57|
73817229|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.525|||||TWO_SIDED|95.0|-141.27|96.22|||||Comparison of Insulin, iAUC 0-13|||96.22|-141.27|
73817230|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.0|||||TWO_SIDED|95.0|-140.36|96.36|||||Comparison of Insulin, iAUC 0-13|||96.36|-140.36|
73817231|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.324|||||TWO_SIDED|95.0|-170.95|38.3|||||Comparison of Insulin, iAUC 0-13|||38.30|-170.95|
73817232|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.982|||||TWO_SIDED|95.0|-2.66|14.62|||||Comparison of PYY total, AUC 0-12|||14.62|-2.66|
73817233|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.908|||||TWO_SIDED|95.0|-0.05|17.86|||||Comparison of PYY total, AUC 0-12|||17.86|-0.05|
73817234|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.317|||||TWO_SIDED|95.0|5.39|23.24|||||Comparison of PYY total, AUC 0-12|||23.24|5.39|
73817235|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-13.33|2.45|||||Comparison of PYY total, AUC 0-12|||2.45|-13.33|
73817236|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.999|||||TWO_SIDED|95.0|-1.87|11.87|||||Comparison of PYY total, iAUC 0-12|||11.87|-1.87|
73817237|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.909|||||TWO_SIDED|95.0|-0.22|14.03|||||Comparison of PYY total, iAUC 0-12|||14.03|-0.22|
73817238|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.036|||||TWO_SIDED|95.0|1.93|16.14|||||Comparison of PYY total, iAUC 0-12|||16.14|1.93|
73817239|NCT01119846|147183279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.39|||||TWO_SIDED|95.0|-12.67|-0.11|||||Comparison of PYY total, iAUC 0-12|||-0.11|-12.67|
73817240|NCT01119846|147183280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.564|||||TWO_SIDED|95.0|-2.69|1.56|||||Comparison of AUC 0-3|||1.56|-2.69|
73817241|NCT01119846|147183280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.846|||||TWO_SIDED|95.0|-3.05|1.36|||||Comparison of AUC 0-3|||1.36|-3.05|
73817242|NCT01119846|147183280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.175|||||TWO_SIDED|95.0|-3.37|1.02|||||Comparison of AUC 0-3|||1.02|-3.37|
73817243|NCT01119846|147183280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.617|||||TWO_SIDED|95.0|-2.56|1.33|||||Comparison of AUC 0-3|||1.33|-2.56|
73817244|NCT01119846|147183280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.626|||||TWO_SIDED|95.0|-1.64|0.39|||||Comparison of iAUC 0-3|||0.39|-1.64|
73817245|NCT01119846|147183280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.956|||||TWO_SIDED|95.0|-2.01|0.09|||||Comparison of iAUC 0-3|||0.09|-2.01|
73817246|NCT01119846|147183280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.103|||||TWO_SIDED|95.0|-2.15|-0.06|||||Comparison of iAUC 0-3|||-0.06|-2.15|
73817247|NCT01119846|147183280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||||TWO_SIDED|95.0|-1.91|-0.07|||||Comparison of iAUC 0-3|||-0.07|-1.91|
73817248|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|152.962|||||TWO_SIDED|95.0|-200.57|506.49|||||Comparison of C-peptide, AUC 0-2|||506.49|-200.57|
73817249|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.866|||||TWO_SIDED|95.0|-252.69|480.42|||||Comparison of C-peptide, AUC 0-2|||480.42|-252.69|
73817250|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|114.474|||||TWO_SIDED|95.0|-250.89|479.83|||||Comparison of C-peptide, AUC 0-2|||479.83|-250.89|
73817251|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|136.638|||||TWO_SIDED|95.0|-186.32|459.6|||||Comparison of C-peptide, AUC 0-2|||459.60|-186.32|
73817252|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|163.622|||||TWO_SIDED|95.0|-127.31|454.55|||||Comparison of C-peptide, iAUC 0-2|||454.55|-127.31|
73817253|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.074|||||TWO_SIDED|95.0|-243.57|359.72|||||Comparison of C-peptide, iAUC 0-2|||359.72|-243.57|
73817254|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.341|||||TWO_SIDED|95.0|-222.32|379.0|||||Comparison of C-peptide, iAUC 0-2|||379.00|-222.32|
73817255|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|157.044|||||TWO_SIDED|95.0|-108.73|422.82|||||Comparison of C-peptide, iAUC 0-2|||422.82|-108.73|
73817256|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.539|||||TWO_SIDED|95.0|-4.79|17.87|||||Comparison of GIP total, AUC 0-2|||17.87|-4.79|
73817257|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.095|||||TWO_SIDED|95.0|-7.65|15.84|||||Comparison of GIP total, AUC 0-2|||15.84|-7.65|
73817258|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.033|||||TWO_SIDED|95.0|1.33|24.74|||||Comparison of GIP total, AUC 0-2|||24.74|1.33|
73817259|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.824|||||TWO_SIDED|95.0|-13.17|7.52|||||Comparison of GIP total, AUC 0-2|||7.52|-13.17|
73817260|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.227|||||TWO_SIDED|95.0|-3.47|15.93|||||Comparison of GIP total, iAUC 0-2|||15.93|-3.47|
73817261|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.598|||||TWO_SIDED|95.0|-5.46|14.65|||||Comparison of GIP total, iAUC 0-2|||14.65|-5.46|
73817262|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.484|||||TWO_SIDED|95.0|-0.54|19.51|||||Comparison of GIP total, iAUC 0-2|||19.51|-0.54|
73817263|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.786|||||TWO_SIDED|95.0|-11.65|6.08|||||Comparison of GIP total, iAUC 0-2|||6.08|-11.65|
73817264|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|||||TWO_SIDED|95.0|-0.38|0.52|||||Comparison of GLP-1 active, AUC 0-2|||0.52|-0.38|
73817265|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|||||TWO_SIDED|95.0|-0.21|0.72|||||Comparison of GLP-1 active, AUC 0-2|||0.72|-0.21|
73817266|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||||TWO_SIDED|95.0|-0.42|0.51|||||Comparison of GLP-1 active, AUC 0-2|||0.51|-0.42|
73817267|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.694|||||TWO_SIDED|95.0|2.28|3.11|||||Comparison of GLP-1 active, AUC 0-2|||3.11|2.28|
73817268|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.36|0.5|||||Comparison of GLP-1 active, iAUC 0-2|||0.50|-0.36|
73817269|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|||||TWO_SIDED|95.0|-0.2|0.69|||||Comparison of GLP-1 active, iAUC 0-2|||0.69|-0.20|
73817270|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|||||TWO_SIDED|95.0|-0.41|0.47|||||Comparison of GLP-1 active, iAUC 0-2|||0.47|-0.41|
73817271|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.643|||||TWO_SIDED|95.0|2.25|3.04|||||Comparison of GLP-1 active, iAUC 0-2|||3.04|2.25|
73817272|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||||TWO_SIDED|95.0|-1.44|1.55|||||Comparison of GLP-1 total, AUC 0-2|||1.55|-1.44|
73817273|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|||||TWO_SIDED|95.0|-1.28|1.82|||||Comparison of GLP-1 total, AUC 0-2|||1.82|-1.28|
73817274|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.894|||||TWO_SIDED|95.0|-0.65|2.44|||||Comparison of GLP-1 total, AUC 0-2|||2.44|-0.65|
73817275|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.483|||||TWO_SIDED|95.0|-2.85|-0.12|||||Comparison of GLP-1 total, AUC 0-2|||-0.12|-2.85|
73817276|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|||||TWO_SIDED|95.0|-1.18|1.34|||||Comparison of GLP-1 total, iAUC 0-2|||1.34|-1.18|
73817277|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|||||TWO_SIDED|95.0|-0.97|1.63|||||Comparison of GLP-1 total, iAUC 0-2|||1.63|-0.97|
73817278|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.177|||||TWO_SIDED|95.0|-1.48|1.12|||||Comparison of GLP-1 total, iAUC 0-2|||1.12|-1.48|
73817279|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.19|||||TWO_SIDED|95.0|-2.34|-0.04|||||Comparison of GLP-1 total, iAUC 0-2|||-0.04|-2.34|
73817280|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.235|||||TWO_SIDED|95.0|-1.51|3.98|||||Comparison of Glucagon, AUC 0-2|||3.98|-1.51|
73817281|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.877|||||TWO_SIDED|95.0|0.04|5.71|||||Comparison of Glucagon, AUC 0-2|||5.71|0.04|
73817282|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.473|||||TWO_SIDED|95.0|-1.21|4.16|||||Comparison of Glucagon, AUC 0-2|||4.16|-1.21|
73817283|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.274|||||TWO_SIDED|95.0|-2.2|2.74|||||Comparison of Glucagon, AUC 0-2|||2.74|-2.20|
73817284|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.177|||||TWO_SIDED|95.0|-4.92|0.56|||||Comparison of Glucagon, iAUC 0-2|||0.56|-4.92|
73817285|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.909|||||TWO_SIDED|95.0|-4.74|0.93|||||Comparison of Glucagon, iAUC 0-2|||0.93|-4.74|
73817286|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.053|||||TWO_SIDED|95.0|-3.74|1.63|||||Comparison of Glucagon, iAUC 0-2|||1.63|-3.74|
73817287|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.249|||||TWO_SIDED|95.0|-3.72|1.22|||||Comparison of Glucagon, iAUC 0-2|||1.22|-3.72|
73817288|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.389|||||TWO_SIDED|95.0|-95.82|122.59|||||Comparison of Insulin, AUC 0-3|||122.59|-95.82|
73817289|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|||||TWO_SIDED|95.0|-103.25|123.21|||||Comparison of Insulin, AUC 0-3|||123.21|-103.25|
73817290|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.426|||||TWO_SIDED|95.0|-80.43|145.28|||||Comparison of Insulin, AUC 0-3|||145.28|-80.43|
73817291|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.994|||||TWO_SIDED|95.0|-76.77|122.76|||||Comparison of Insulin, AUC 0-3|||122.76|-76.77|
73817292|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.088|||||TWO_SIDED|95.0|-86.79|90.97|||||Comparison of Insulin, iAUC 0-3|||90.97|-86.79|
73817293|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||||TWO_SIDED|95.0|-92.47|91.84|||||Comparison of Insulin, iAUC 0-3|||91.84|-92.47|
73817294|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.053|||||TWO_SIDED|95.0|-71.8|111.91|||||Comparison of Insulin, iAUC 0-3|||111.91|-71.80|
73817295|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.606|||||TWO_SIDED|95.0|-57.59|104.8|||||Comparison of Insulin, iAUC 0-3|||104.80|-57.59|
73817296|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.506|||||TWO_SIDED|95.0|-3.13|10.14|||||Comparison of PYY total, AUC 0-2|||10.14|-3.13|
73817297|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.295|||||TWO_SIDED|95.0|0.41|14.18|||||Comparison of PYY total, AUC 0-2|||14.18|0.41|
73817298|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.006|||||TWO_SIDED|95.0|0.15|13.87|||||Comparison of PYY total, AUC 0-2|||13.87|0.15|
73817299|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.555|||||TWO_SIDED|95.0|-8.62|3.51|||||Comparison of PYY total, AUC 0-2|||3.51|-8.62|
73817300|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.523|||||TWO_SIDED|95.0|-2.13|7.17|||||Comparison of PYY total, iAUC 0-2|||7.17|-2.13|
73817301|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.296|||||TWO_SIDED|95.0|0.47|10.12|||||Comparison of PYY total, iAUC 0-2|||10.12|0.47|
73817302|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.726|||||TWO_SIDED|95.0|-3.08|6.53|||||Comparison of PYY total, iAUC 0-2|||6.53|-3.08|
73817303|NCT01119846|147183281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.506|||||TWO_SIDED|95.0|-7.75|0.74|||||Comparison of PYY total, iAUC 0-2|||0.74|-7.75|
73817304|NCT01119846|147183282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|||||TWO_SIDED|95.0|-0.84|1.32||||||||1.32|-0.84|
73817305|NCT01119846|147183282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.523|||||TWO_SIDED|95.0|-0.6|1.64||||||||1.64|-0.60|
73817306|NCT01119846|147183282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|||||TWO_SIDED|95.0|-1.17|1.06||||||||1.06|-1.17|
73817307|NCT01119846|147183282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||||TWO_SIDED|95.0|-0.81|1.16||||||||1.16|-0.81|
73817308|NCT01119846|147183283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.08|0.06|||||Comparison of G/I ratio|||0.06|-0.08|
73817309|NCT01119846|147183283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|||||TWO_SIDED|95.0|-0.07|0.07|||||Comparison of G/I ratio|||0.07|-0.07|
73817310|NCT01119846|147183283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|||||TWO_SIDED|95.0|-0.07|0.07|||||Comparison of G/I ratio|||0.07|-0.07|
73817311|NCT01119846|147183283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.04|0.08|||||Comparison of G/I ratio|||0.08|-0.04|
73817312|NCT01119846|147183283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.269|||||TWO_SIDED|95.0|-8.31|12.85|||||Comparison of I/G ratio|||12.85|-8.31|
73817313|NCT01119846|147183283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.959|||||TWO_SIDED|95.0|-8.01|13.93|||||Comparison of I/G ratio|||13.93|-8.01|
73817314|NCT01119846|147183283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.053|||||TWO_SIDED|95.0|-4.88|16.99|||||Comparison of I/G ratio|||16.99|-4.88|
73817315|NCT01119846|147183283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.017|||||TWO_SIDED|95.0|-5.65|13.68|||||Comparison of I/G ratio|||13.68|-5.65|
73817316|NCT01119846|147183284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|||||TWO_SIDED|95.0|-0.28|0.22|||||Comparison of insulin glucose index|||0.22|-0.28|
73817317|NCT01119846|147183284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||||TWO_SIDED|95.0|-0.2|0.31|||||Comparison of insulin glucose index|||0.31|-0.20|
73817318|NCT01119846|147183284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|||||TWO_SIDED|95.0|-0.29|0.23|||||Comparison of insulin glucose index|||0.23|-0.29|
73817319|NCT01119846|147183284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.041|||||TWO_SIDED|95.0|-0.27|0.19|||||Comparison of insulin glucose index|||0.19|-0.27|
73817320|NCT01119846|147183285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|||||TWO_SIDED|95.0|-2.06|1.37||||||||1.37|-2.06|
73817321|NCT01119846|147183285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||||TWO_SIDED|95.0|-1.82|1.73||||||||1.73|-1.82|
73817322|NCT01119846|147183285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.388|||||TWO_SIDED|95.0|-2.16|1.38||||||||1.38|-2.16|
73817323|NCT01119846|147183285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|||||TWO_SIDED|95.0|-1.43|1.7||||||||1.70|-1.43|
73817324|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.523|||||TWO_SIDED|95.0|-3.04|2.0|||||Comparison of Day 7, 1 Hour|||2.00|-3.04|
73817325|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.569|||||TWO_SIDED|95.0|-3.07|1.94|||||Comparison of Day 7, 1 Hour|||1.94|-3.07|
73817326|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.064|||||TWO_SIDED|95.0|-0.45|4.57|||||Comparison of Day 7, 1 Hour|||4.57|-0.45|
73817327|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.316|||||TWO_SIDED|95.0|-2.19|2.82|||||Comparison of Day 7, 1 Hour|||2.82|-2.19|
73817328|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.484|||||TWO_SIDED|95.0|-3.99|1.02|||||Comparison of Day 7, 1 Hour|||1.02|-3.99|
73817329|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.795|||||TWO_SIDED|95.0|-3.27|1.68|||||Comparison of Day 7, 2 Hours|||1.68|-3.27|
73817330|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.313|||||TWO_SIDED|95.0|-2.78|2.15|||||Comparison of Day 7, 2 Hours|||2.15|-2.78|
73817331|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.441|||||TWO_SIDED|95.0|-0.03|4.91|||||Comparison of Day 7, 2 Hours|||4.91|-0.03|
73817332|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.884|||||TWO_SIDED|95.0|-1.58|3.34|||||Comparison of Day 7, 2 Hours|||3.34|-1.58|
73817333|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.222|||||TWO_SIDED|95.0|-3.69|1.24|||||Comparison of Day 7, 2 Hours|||1.24|-3.69|
73817334|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.017|||||TWO_SIDED|95.0|-2.06|2.03|||||Comparison of Day 7, 4 Hours|||2.03|-2.06|
73817335|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-1.56|2.51|||||Comparison of Day 7, 4 Hours|||2.51|-1.56|
73817336|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.512|||||TWO_SIDED|95.0|-0.53|3.55|||||Comparison of Day 7, 4 Hours|||3.55|-0.53|
73817337|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.233|||||TWO_SIDED|95.0|-0.8|3.26|||||Comparison of Day 7, 4 Hours|||3.26|-0.80|
73817338|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.011|||||TWO_SIDED|95.0|-3.05|1.02|||||Comparison of Day 7, 4 Hours|||1.02|-3.05|
73817339|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.189|||||TWO_SIDED|95.0|-3.05|2.67|||||Comparison of Day 7, 6 Hours|||2.67|-3.05|
73817340|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.456|||||TWO_SIDED|95.0|-2.39|3.3|||||Comparison of Day 7, 6 Hours|||3.30|-2.39|
73817341|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.706|||||TWO_SIDED|95.0|-0.14|5.56|||||Comparison of Day 7, 6 Hours|||5.56|-0.14|
73817342|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.062|||||TWO_SIDED|95.0|-1.78|3.91|||||Comparison of Day 7, 6 Hours|||3.91|-1.78|
73817343|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.708|||||TWO_SIDED|95.0|-5.55|0.14|||||Comparison of Day 7, 6 Hours|||0.14|-5.55|
73817344|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|||||TWO_SIDED|95.0|-2.41|2.7|||||Comparison of Day 7, 10 Hours|||2.70|-2.41|
73817345|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.452|||||TWO_SIDED|95.0|-2.09|2.99|||||Comparison of Day 7, 10 Hours|||2.99|-2.09|
73817346|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.418|||||TWO_SIDED|95.0|-0.13|4.96|||||Comparison of Day 7, 10 Hours|||4.96|-0.13|
73817347|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.063|||||TWO_SIDED|95.0|-1.47|3.6|||||Comparison of Day 7, 10 Hours|||3.60|-1.47|
73817348|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.509|||||TWO_SIDED|95.0|-4.05|1.03|||||Comparison of Day 7, 10 Hours|||1.03|-4.05|
73817349|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-4.2|1.6|||||Comparison of Day 7, 12 Hours|||1.60|-4.20|
73817350|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.325|||||TWO_SIDED|95.0|-4.21|1.56|||||Comparison of Day 7, 12 Hours|||1.56|-4.21|
73817351|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-1.89|3.89|||||Comparison of Day 7, 12 Hours|||3.89|-1.89|
73817352|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.265|||||TWO_SIDED|95.0|-3.14|2.62|||||Comparison of Day 7, 12 Hours|||2.62|-3.14|
73817353|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.516|||||TWO_SIDED|95.0|-3.4|2.37|||||Comparison of Day 7, 12 Hours|||2.37|-3.40|
73817354|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.515|||||TWO_SIDED|95.0|-2.29|1.26|||||Comparison of Day 14, 24 Hours|||1.26|-2.29|
73817355|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.225|||||TWO_SIDED|95.0|-1.99|1.55|||||Comparison of Day 14, 24 Hours|||1.55|-1.99|
73817356|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.501|||||TWO_SIDED|95.0|-1.28|2.28|||||Comparison of Day 14, 24 Hours|||2.28|-1.28|
73817357|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.168|||||TWO_SIDED|95.0|-1.98|1.65|||||Comparison of Day 14, 24 Hours|||1.65|-1.98|
73817358|NCT01119846|147183286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.043|||||TWO_SIDED|95.0|-2.81|0.73|||||Comparison of Day 14, 24 Hours|||0.73|-2.81|
73817359|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-70.457|||||TWO_SIDED|95.0|-214.72|73.8|||||Day 7, 1 Hour|||73.80|-214.72|
73817360|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-151.722|||||TWO_SIDED|95.0|-295.98|-7.46|||||Day 7, 1 Hour|||-7.46|-295.98|
73817361|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-69.113|||||TWO_SIDED|95.0|-213.48|75.25|||||Day 7, 1 Hour|||75.25|-213.48|
73817362|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-104.468|||||TWO_SIDED|95.0|-248.72|39.78|||||Day 7, 1 Hour|||39.78|-248.72|
73817363|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-118.462|||||TWO_SIDED|95.0|-263.93|27.01|||||Day 7, 1 Hour|||27.01|-263.93|
73817364|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-114.34|||||TWO_SIDED|95.0|-264.78|36.1|||||Day 7, 2 Hours|||36.10|-264.78|
73817365|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-116.462|||||TWO_SIDED|95.0|-266.9|33.98|||||Day 7, 2 Hours|||33.98|-266.90|
73817366|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.201|||||TWO_SIDED|95.0|-154.75|146.35|||||Day 7, 2 Hours|||146.35|-154.75|
73817367|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.27|||||TWO_SIDED|95.0|-198.7|102.16|||||Day 7, 2 Hours|||102.16|-198.70|
73817368|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-50.605|||||TWO_SIDED|95.0|-202.31|101.1|||||Day 7, 2 Hours|||101.10|-202.31|
73817369|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.231|||||TWO_SIDED|95.0|-40.84|26.38|||||Day 7, 4 Hours|||26.38|-40.84|
73817370|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.025|||||TWO_SIDED|95.0|-38.63|28.58|||||Day 7, 4 Hours|||28.58|-38.63|
73817371|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.523|||||TWO_SIDED|95.0|-24.11|43.16|||||Day 7, 4 Hours|||43.16|-24.11|
73817372|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.618|||||TWO_SIDED|95.0|-36.22|30.99|||||Day 7, 4 Hours|||30.99|-36.22|
73817373|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.8|||||TWO_SIDED|95.0|-13.09|54.69|||||Day 7, 4 Hours|||54.69|-13.09|
73817374|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-58.864|||||TWO_SIDED|95.0|-156.11|38.38|||||Day 7, 6 Hours|||38.38|-156.11|
73817375|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-77.9|||||TWO_SIDED|95.0|-175.15|19.35|||||Day 7, 6 Hours|||19.35|-175.15|
73817376|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.323|||||TWO_SIDED|95.0|-69.0|125.65|||||Day 7, 6 Hours|||125.65|-69.00|
73817377|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.499|||||TWO_SIDED|95.0|-121.74|72.74|||||Day 7, 6 Hours|||72.74|-121.74|
73817378|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-59.755|||||TWO_SIDED|95.0|-157.82|38.31|||||Day 7, 6 Hours|||38.31|-157.82|
73817379|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222|||||TWO_SIDED|95.0|-69.85|69.4|||||Day 7, 10 Hours|||69.40|-69.85|
73817380|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222|||||TWO_SIDED|95.0|-77.28|61.98|||||Day 7, 10 Hours|||61.98|-77.28|
73817381|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.148|||||TWO_SIDED|95.0|-62.55|76.85|||||Day 7, 10 Hours|||76.85|-62.55|
73817382|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.734|||||TWO_SIDED|95.0|-36.89|102.36|||||Day 7, 10 Hours|||102.36|-36.89|
73817383|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.76|||||TWO_SIDED|95.0|-81.01|61.49|||||Day 7, 10 Hours|||61.49|-81.01|
73817384|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.594|||||TWO_SIDED|95.0|-123.36|84.18|||||Day 7, 12 Hours|||84.18|-123.36|
73817385|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.924|||||TWO_SIDED|95.0|-150.69|56.85|||||Day 7, 12 Hours|||56.85|-150.69|
73817386|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.715|||||TWO_SIDED|95.0|-79.16|128.59|||||Day 7, 12 Hours|||128.59|-79.16|
73817387|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.966|||||TWO_SIDED|95.0|-111.73|95.8|||||Day 7, 12 Hours|||95.80|-111.73|
73817388|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.108|||||TWO_SIDED|95.0|-103.08|109.29|||||Day 7, 12 Hours|||109.29|-103.08|
73817389|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.114|||||TWO_SIDED|95.0|-25.12|4.89|||||Day 14, 24 Hours|||4.89|-25.12|
73817390|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.718|||||TWO_SIDED|95.0|-23.71|6.28|||||Day 14, 24 Hours|||6.28|-23.71|
73817391|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.622|||||TWO_SIDED|95.0|-15.63|14.38|||||Day 14, 24 Hours|||14.38|-15.63|
73817392|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.454|||||TWO_SIDED|95.0|-27.78|2.88|||||Day 14, 24 Hours|||2.88|-27.78|
73817393|NCT01119846|147183287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.681|||||TWO_SIDED|95.0|-24.02|6.66|||||Day 14, 24 Hours|||6.66|-24.02|
73817394|NCT00795769|147183303|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 1 sided|||18% n=9 of the patients vomited compared to the FHCRC historic rate of 28%. p=0.03. PMID: 21372706 reference for historical data at FHCRC.||||0.03
73817395|NCT00795769|147183303|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|||Twelve patients (24%) had a greater than two-point increase in MAT score for nausea from baseline by the end of their infusion. That rate compares to the FHCRC historic rate of 58% (p \<0.0001). PMID: 21372706 reference for historical data at FHCRC||||<0.0001
73817396|NCT03304184|147183306|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine)|Mean Difference (Final Values)|3.0||||0.0001|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0001
73817397|NCT03304184|147183306|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine) over timepoints|Mean Difference (Final Values)|3.0||||0.0005|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0005
73817398|NCT03304184|147183307|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine).|Mean Difference (Final Values)|3.0||||0.091|TWO_SIDED|95.0||||Comparison between two groups for treatment|ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0910
73817399|NCT03304184|147183307|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine) over time points|Mean Difference (Final Values)|3.0||||0.0262|TWO_SIDED|95.0||||Comparison between the two arms for treatment time points with analysis|ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0262
73817400|NCT03304184|147183308|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in brief pain inventory scores between the two treatment groups (Photac and Biodentine) over different time points.|Mean Difference (Final Values)|3.0||||0.0289|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0289
73817401|NCT00212264|147183310|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||.001
73817402|NCT00212264|147183311|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 1 sided|Note that the no-treatment control group completed the study after 2 months and was not included in this analysis of treatment effect durability.||||||.32
73817403|NCT03244618|147183336|SUPERIORITY||Mean Difference (Final Values)|-0.544|||<|0.001|TWO_SIDED|95.0|-0.712|-0.377|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours first named toothpaste.|||-0.377|-0.712|<0.001
73817404|NCT03244618|147183337|SUPERIORITY||Mean Difference (Final Values)|10.8|||<|0.001|TWO_SIDED|95.0|7.5|14.0|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first names toothpaste minus second named toothpaste such that a positive difference favours the first named toothpaste.|||14.0|7.5|<0.001
73817405|NCT03244618|147183338|SUPERIORITY||Mean Difference (Final Values)|-11.0|||<|0.001|TWO_SIDED|95.0|-16.4|-5.5|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.|||-5.5|-16.4|<0.001
73817406|NCT03244618|147183339|SUPERIORITY||Mean Difference (Final Values)|-0.67|||<|0.001|TWO_SIDED|95.0|-0.85|-0.489|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative value favours the first named toothpaste.|||-0.489|-0.850|<0.001
73817407|NCT03244618|147183340|SUPERIORITY||Mean Difference (Final Values)|11.9|||<|0.001|TWO_SIDED|95.0|8.6|15.1|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a positive difference favours first named toothpaste|||15.1|8.6|<0.001
73817408|NCT03244618|147183341|SUPERIORITY||Mean Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-16.6|-5.2|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.|||-5.2|-16.6|<0.001
73817409|NCT02620384|147183375|SUPERIORITY||Mean Difference (Final Values)|2439.511|STANDARD_ERROR_OF_MEAN|646.2707|<|0.0001|TWO_SIDED|95.0|1160.8485|3718.1734|||t-test, 2 sided|||||3718.1734|1160.8485|<0.0001
73817410|NCT02620384|147183376|SUPERIORITY||Mean Difference (Final Values)|-2249.3294|STANDARD_ERROR_OF_MEAN|608.2782|<|0.0001|TWO_SIDED|95.0|-3454.4999|-1044.1589|||t-test, 2 sided|||||-1044.1589|-3454.4999|<0.0001
73817411|NCT02620384|147183377|SUPERIORITY||Mean Difference (Final Values)|-2.717121|STANDARD_ERROR_OF_MEAN|0.586647|<|0.0001|TWO_SIDED|95.0|-3.8637732|-1.54651|||t-test, 2 sided|||||-1.546510|-3.8637732|<0.0001
73817412|NCT02620384|147183378|SUPERIORITY||Mean Difference (Final Values)|-0.6955|STANDARD_ERROR_OF_MEAN|0.2806||0.014|TWO_SIDED|95.0|-1.2506|-0.1403||Represents BORG\_48\_hours|t-test, 2 sided||Method of estimation is for 48 hour measure.|||-.1403|-1.2506|.014
73817413|NCT02620384|147183379|SUPERIORITY||Mean Difference (Final Values)|3.6903|STANDARD_ERROR_OF_MEAN|72.4074||0.959|TWO_SIDED|95.0|-1395694.0|147.1545|||t-test, 2 sided|||||147.1545|-1395694|.959
73817414|NCT02620384|147183380|SUPERIORITY|||||||0.144|||||||Chi-squared|||||||.144
73817415|NCT02620384|147183381|SUPERIORITY|||||||0.171|||||||Chi-squared|||||||.171
73817416|NCT02620384|147183382|SUPERIORITY||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.734||0.885|TWO_SIDED|95.0|-1.346|1.558|||t-test, 2 sided|||||1.558|-1.346|.885
73817417|NCT02620384|147183383|SUPERIORITY|||||||0.804|||||||Chi-squared|||||||.804
73817418|NCT02620384|147183384|SUPERIORITY|||||||0.403|||||||Chi-squared|||||||.403
73817419|NCT02620384|147183385|SUPERIORITY|||||||0.08|||||||Chi-squared|||||||.080
73817420|NCT02620384|147183386|SUPERIORITY|||||||0.559|||||||Chi-squared|||||||.559
73817421|NCT01483599|147183400|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (less than or equal to (\<=) 90 kilogram (kg), greater than (\>) 90 kg).||||0.002
73817422|NCT01483599|147183400|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
73817423|NCT01483599|147183400|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
73817424|NCT01483599|147183400|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
73817425|NCT01483599|147183400|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
73817426|NCT01483599|147183400|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
73817427|NCT01483599|147183401|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
73817428|NCT01483599|147183401|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
73817429|NCT01483599|147183401|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
73817430|NCT01483599|147183401|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
73817431|NCT01483599|147183401|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
73817432|NCT01483599|147183401|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
73817433|NCT01483599|147183402|SUPERIORITY_OR_OTHER||Difference in Percentage|-24.0|||||TWO_SIDED|95.0|-44.0|-4.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||-4.0|-44.0|
73817434|NCT01483599|147183402|SUPERIORITY_OR_OTHER||Difference in Percentage|2.8|||||TWO_SIDED|95.0|-17.9|23.5||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||23.5|-17.9|
73817435|NCT01483599|147183402|SUPERIORITY_OR_OTHER||Difference in Percentage|20.4|||||TWO_SIDED|95.0|1.5|39.3||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||39.3|1.5|
73817436|NCT01483599|147183402|SUPERIORITY_OR_OTHER||Difference in Percentage|27.7|||||TWO_SIDED|95.0|9.8|45.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||45.6|9.8|
73817437|NCT01483599|147183402|SUPERIORITY_OR_OTHER||Difference in Percentage|25.4|||||TWO_SIDED|95.0|7.2|43.6||||||||43.6|7.2|
73817438|NCT01483599|147183403|SUPERIORITY_OR_OTHER||Difference in Percentage|-15.4|||||TWO_SIDED|95.0|-37.7|6.9||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||6.9|-37.7|
73817439|NCT01483599|147183403|SUPERIORITY_OR_OTHER||Difference in Percentage|10.8|||||TWO_SIDED|95.0|-10.7|32.4||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||32.4|-10.7|
73817440|NCT01483599|147183403|SUPERIORITY_OR_OTHER||Difference in Percentage|22.7|||||TWO_SIDED|95.0|1.8|43.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||43.6|1.8|
73817441|NCT01483599|147183403|SUPERIORITY_OR_OTHER||Difference in Percentage|28.7|||||TWO_SIDED|95.0|8.5|49.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||49.0|8.5|
73817442|NCT01483599|147183403|SUPERIORITY_OR_OTHER||Difference in Percentage|32.9|||||TWO_SIDED|95.0|13.0|52.8||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||52.8|13.0|
73817443|NCT01483599|147183404|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANOVA on the van Der Waerden score|||||||0.008
73817444|NCT01483599|147183404|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
73817445|NCT01483599|147183404|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
73817446|NCT01483599|147183404|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
73817447|NCT01483599|147183404|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
73817448|NCT01483599|147183404|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
73817449|NCT01421147|147183407|SUPERIORITY_OR_OTHER||LS Mean Difference|0.108||||0.055|TWO_SIDED|95.0|-0.002|0.219|||ANCOVA|||||0.219|-0.002|0.055
73817450|NCT01421147|147183408|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.205|TWO_SIDED|95.0|-0.23|1.05||P-value is for change at 6 weeks.|ANCOVA|||||1.05|-0.23|0.205
73817451|NCT01421147|147183408|SUPERIORITY_OR_OTHER||LS Mean difference|0.4||||0.32|TWO_SIDED|95.0|-0.4|1.21||P-value is for change at 12 weeks.|ANCOVA|||||1.21|-0.40|0.320
73817452|NCT01421147|147183408|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.373|TWO_SIDED|95.0|-0.46|1.21||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA|||||1.21|-0.46|0.373
73817453|NCT01421147|147183408|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.131|TWO_SIDED|95.0|-0.25|1.86||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||1.86|-0.25|0.131
73817454|NCT01421147|147183409|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.007||||0.86|TWO_SIDED|95.0|-0.087|0.072||P-value is for change at 6 weeks.|ANCOVA|||||0.072|-0.087|0.860
73817455|NCT01421147|147183409|SUPERIORITY_OR_OTHER||LS Mean Difference|0.113||||0.03|TWO_SIDED|95.0|0.011|0.215||P-value is for change at 12 weeks.|ANCOVA|||||0.215|0.011|0.030
73817456|NCT01421147|147183409|SUPERIORITY_OR_OTHER||LS Mean Difference|0.098||||0.08|TWO_SIDED|95.0|-0.012|0.208||P-value is for change at 24 weeks.|ANCOVA|||||0.208|-0.012|0.080
73817457|NCT01421147|147183409|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.314|TWO_SIDED|95.0|-0.057|0.177||P-value is for change at 36 weeks.|ANCOVA|||||0.177|-0.057|0.314
73817458|NCT01421147|147183409|SUPERIORITY_OR_OTHER||LS Mean Difference|0.004||||0.948|TWO_SIDED|95.0|-0.119|0.127||P-value is for change at 52 weeks.|ANCOVA|||||0.127|-0.119|0.948
73817459|NCT01421147|147183409|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.737|TWO_SIDED|95.0|-0.099|0.14||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||0.140|-0.099|0.737
73817460|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.489|TWO_SIDED|95.0|-0.33|0.69||P-value is for Baseline-AM Pre-Meal.|ANCOVA|||||0.69|-0.33|0.489
73817461|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.066|TWO_SIDED|95.0|-1.0|0.03||P-value is for Baseline-AM 2 hrs PP.|ANCOVA|||||0.03|-1.00|0.066
73817462|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28||||0.209|TWO_SIDED|95.0|-0.71|0.16||P-value is for Baseline-MD Pre-Meal.|ANCOVA|||||0.16|-0.71|0.209
73817463|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31||||0.232|TWO_SIDED|95.0|-0.2|0.82||P-value is for Baseline-MD 2 hrs PP.|ANCOVA|||||0.82|-0.20|0.232
73817464|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.856|TWO_SIDED|95.0|-0.49|0.58||P-value is for Baseline-EV Pre-Meal.|ANCOVA|||||0.58|-0.49|0.856
73817465|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11||||0.693|TWO_SIDED|95.0|-0.66|0.44||P-value is for Baseline-Bed Time.|ANCOVA|||||0.44|-0.66|0.693
73817466|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.7|TWO_SIDED|95.0|-0.61|0.41||P-value is for Baseline-0300 hrs.|ANCOVA|||||0.41|-0.61|0.700
73817467|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.399|TWO_SIDED|95.0|-0.23|0.58||P-value is for Endpoint, up to 24 wk-AM Pre-Meal.|ANCOVA|||||0.58|-0.23|0.399
73817468|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.248|TWO_SIDED|95.0|-0.18|0.68||P-value is for Endpoint, up to 24 wk-AM 2 hrs PP.|ANCOVA|||||0.68|-0.18|0.248
73817469|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.883|TWO_SIDED|95.0|-0.44|0.38||P-value is for Endpoint, up to 24 wk-MD Pre-Meal.|ANCOVA|||||0.38|-0.44|0.883
73817470|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.687|TWO_SIDED|95.0|-0.34|0.52||P-value is for Endpoint, up to 24 wk-MD 2 hrs PP.|ANCOVA|||||0.52|-0.34|0.687
73817471|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.364|TWO_SIDED|95.0|-0.24|0.65||P-value is for Endpoint, up to 24 wk-EV Pre-Meal.|ANCOVA|||||0.65|-0.24|0.364
73817472|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.03|TWO_SIDED|95.0|-0.95|-0.05||P-value is for Endpoint, up to 24 wk- Bed Time.|ANCOVA|||||-0.05|-0.95|0.030
73817473|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45||||0.033|TWO_SIDED|95.0|-0.86|-0.04||P-value is for Endpoint, up to 24 wk-0300 hrs.|ANCOVA|||||-0.04|-0.86|0.033
73817474|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.23|TWO_SIDED|95.0|-0.68|0.16||P-value is for Endpoint, up to 52 wk-AM Pre-Meal.|ANCOVA|||||0.16|-0.68|0.230
73817475|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.148|TWO_SIDED|95.0|-0.76|0.11||P-value is for Endpoint, up to 52 wk-AM 2 hrs PP.|ANCOVA|||||0.11|-0.76|0.148
73817476|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.866|TWO_SIDED|95.0|-0.43|0.36||P-value is for Endpoint, up to 52 wk-MD Pre-Meal.|ANCOVA|||||0.36|-0.43|0.866
73817477|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.545|TWO_SIDED|95.0|-0.56|0.3||P-value is for Endpoint, up to 52 wk-MD 2 hrs PP.|ANCOVA|||||0.30|-0.56|0.545
73817478|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.955|TWO_SIDED|95.0|-0.44|0.42||P-value is for Endpoint, up to 52 wk-EV Pre-Meal.|ANCOVA|||||0.42|-0.44|0.955
73817479|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.031|TWO_SIDED|95.0|-0.92|-0.04||P-value is for Endpoint, up to 52 wk-Bed Time.|ANCOVA|||||-0.04|-0.92|0.031
73817480|NCT01421147|147183410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.355|TWO_SIDED|95.0|-0.65|0.23||P-vale is for Endpoint, up to 52 wk-0300 hrs.|ANCOVA|||||0.23|-0.65|0.355
73817481|NCT01421147|147183411|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.32|TWO_SIDED|95.0|-0.52|0.17||P-value is for Baseline.|ANCOVA|||||0.17|-0.52|0.320
73817482|NCT01421147|147183411|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.781|TWO_SIDED|95.0|-0.33|0.25||P-value is for Endpoint, up to 24 weeks.|ANCOVA|||||0.25|-0.33|0.781
73817483|NCT01421147|147183411|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.06|TWO_SIDED|95.0|-0.53|0.01||P-value is for Endpoint, up to 52 weeks.|ANCOVA|||||0.01|-0.53|0.060
73817484|NCT01421147|147183412|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.823|TWO_SIDED|95.0|-0.23|0.29||P-value is for change at 6 weeks.|ANCOVA|||||0.29|-0.23|0.823
73817485|NCT01421147|147183412|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.541|TWO_SIDED|95.0|-0.25|0.47||P-value is for change at 12 weeks.|ANCOVA|||||0.47|-0.25|0.541
73817486|NCT01421147|147183412|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.435|TWO_SIDED|95.0|-0.25|0.59||P-value is for change at 18 weeks.|ANCOVA|||||0.59|-0.25|0.435
73817487|NCT01421147|147183412|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.32|TWO_SIDED|95.0|-0.23|0.71||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA|||||0.71|-0.23|0.320
73817488|NCT01421147|147183412|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.253|TWO_SIDED|95.0|-0.25|0.93||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||0.93|-0.25|0.253
73817489|NCT01421147|147183413|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.401|TWO_SIDED|95.0|-0.86|2.15||P-value is for Baseline-Behavior TS.|ANCOVA|||||2.15|-0.86|0.401
73817490|NCT01421147|147183413|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.778|TWO_SIDED|95.0|-1.16|1.55||P-value is for 24 weeks-Behavior TS|ANCOVA|||||1.55|-1.16|0.778
73817491|NCT01421147|147183413|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.804|TWO_SIDED|95.0|-1.12|1.45||P-value is for Endpoint, up to 52 weeks-Behavior TS.|ANCOVA|||||1.45|-1.12|0.804
73817492|NCT01421147|147183413|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21||||0.304||95.0|-1.1|3.51||P-value is for Baseline-Worry TS.|ANCOVA|||||3.51|-1.10|0.304
73817493|NCT01421147|147183413|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12||||0.323|TWO_SIDED|95.0|-1.1|3.34||P-value is for 24 weeks-Worry TS.|ANCOVA|||||3.34|-1.10|0.323
73817494|NCT01421147|147183413|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.824||95.0|-1.92|2.41||P-value is for Endpoint, up to 52 weeks-Worry TS.|ANCOVA|||||2.41|-1.92|0.824
73817495|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.77||||0.681|TWO_SIDED|95.0|-4.42|2.89||P-value is for IR-Baseline.|ANCOVA|||||2.89|-4.42|0.681
73817496|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.744|TWO_SIDED|95.0|-2.79|3.9||P-value is for IR-24 weeks.|ANCOVA|||||3.90|-2.79|0.744
73817497|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.94||||0.582|TWO_SIDED|95.0|-4.29|2.41||P-value is for IR-Endpoint, up to 52 weeks.|ANCOVA|||||2.41|-4.29|0.582
73817498|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82||||0.694|TWO_SIDED|95.0|-3.26|4.89||P-value is for LF-Baseline.|ANCOVA|||||4.89|-3.26|0.694
73817499|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.673|TWO_SIDED|95.0|-3.08|4.77||P-value is for LF-24 weeks.|ANCOVA|||||4.77|-3.08|0.673
73817500|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91||||0.645|TWO_SIDED|95.0|-4.79|2.97||P-value is for LF-Endpoint, up to 52 weeks.|ANCOVA|||||2.97|-4.79|0.645
73817501|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.961|TWO_SIDED|95.0|-3.62|3.81||P-value is for GC-Baseline.|ANCOVA|||||3.81|-3.62|0.961
73817502|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25||||0.463|TWO_SIDED|95.0|-2.1|4.61||P-value is for GC-24 weeks.|ANCOVA|||||4.61|-2.10|0.463
73817503|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.609|TWO_SIDED|95.0|-2.59|4.41||P-value is for GC-Endpoint, up to 52 weeks.|ANCOVA|||||4.41|-2.59|0.609
73817504|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61||||0.708|TWO_SIDED|95.0|-3.81|2.59||P-value is for HC-Baseline.|ANCOVA|||||2.59|-3.81|0.708
73817505|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03||||0.51|TWO_SIDED|95.0|-4.09|2.03||P-value is for HC-24 weeks.|ANCOVA|||||2.03|-4.09|0.510
73817506|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26||||0.422|TWO_SIDED|95.0|-4.34|1.82||P-value is for HC-Endpoint, up to 52 weeks.|ANCOVA|||||1.82|-4.34|0.422
73817507|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.53||||0.367|TWO_SIDED|95.0|-4.85|1.8||P-value is for IDD-Baseline.|ANCOVA|||||1.80|-4.85|0.367
73817508|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.786|TWO_SIDED|95.0|-2.54|3.35||P-value is for IDD-24 weeks.|ANCOVA|||||3.35|-2.54|0.786
73817509|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.845|TWO_SIDED|95.0|-3.16|2.59||P-value is for IDD-Endpoint, up to 52 weeks.|ANCOVA|||||2.59|-3.16|0.845
73817510|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59||||0.676|TWO_SIDED|95.0|-3.36|2.18||P-value is for ITSQ Total-Baseline.|ANCOVA|||||2.18|-3.36|0.676
73817511|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.862|TWO_SIDED|95.0|-2.33|2.78||P-value is for ITSQ Total-24 weeks.|ANCOVA|||||2.78|-2.33|0.862
73817512|NCT01421147|147183414|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.685|TWO_SIDED|95.0|-3.15|2.07||P-value is for ITSQ Total-Endpoint, up to 52 weeks.|ANCOVA|||||2.07|-3.15|0.685
73817513|NCT01421147|147183415|SUPERIORITY_OR_OTHER||LS Mean Difference|0.014||||0.235|TWO_SIDED|95.0|-0.009|0.036||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA|||||0.036|-0.009|0.235
73817514|NCT01421147|147183415|SUPERIORITY_OR_OTHER||LS Mean Difference|0.006||||0.726|TWO_SIDED|95.0|-0.026|0.038||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA|||||0.038|-0.026|0.726
73817515|NCT01421147|147183415|SUPERIORITY_OR_OTHER||LS Mean Difference|0.019||||0.377|TWO_SIDED|95.0|-0.023|0.062||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA|||||0.062|-0.023|0.377
73817516|NCT01421147|147183415|SUPERIORITY_OR_OTHER||LS Mean Difference|0.018||||0.159|TWO_SIDED|95.0|-0.007|0.042||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA|||||0.042|-0.007|0.159
73817517|NCT01421147|147183415|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.001||||0.957|TWO_SIDED|95.0|-0.034|0.032||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA|||||0.032|-0.034|0.957
73817518|NCT01421147|147183415|SUPERIORITY_OR_OTHER||LS Mean Difference|0.017||||0.45|TWO_SIDED|95.0|-0.028|0.062||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA|||||0.062|-0.028|0.450
73817519|NCT01421147|147183416|SUPERIORITY_OR_OTHER||LS Mean Difference|1.724||||0.096|TWO_SIDED|95.0|-0.308|3.755||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA|||||3.755|-0.308|0.096
73817520|NCT01421147|147183416|SUPERIORITY_OR_OTHER||LS Mean Difference|1.267||||0.374|TWO_SIDED|95.0|-1.531|4.065||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA|||||4.065|-1.531|0.374
73817521|NCT01421147|147183416|SUPERIORITY_OR_OTHER||LS Mean Difference|2.964||||0.151|TWO_SIDED|95.0|-1.081|7.01||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA|||||7.010|-1.081|0.151
73817522|NCT01421147|147183416|SUPERIORITY_OR_OTHER||LS Mean Difference|2.059||||0.072|TWO_SIDED|95.0|-0.187|4.305||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA|||||4.305|-0.187|0.072
73817523|NCT01421147|147183416|SUPERIORITY_OR_OTHER||LS Mean Difference|0.702||||0.617|TWO_SIDED|95.0|-2.058|3.462||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA|||||3.462|-2.058|0.617
73817524|NCT01421147|147183416|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8||||0.188|TWO_SIDED|95.0|-1.37|6.971||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA|||||6.971|-1.370|0.188
73817525|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.015||||||P-value is for HbA1c- at Baseline \<7.0 %.|Fisher Exact|||||||0.015
73817526|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.606||||||P-value is for HbA1c- at Baseline ≤6.5%.|Fisher Exact|||||||0.606
73817527|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.012||||||P-value is for HbA1c- at 6 weeks \<7.0%.|Fisher Exact|||||||0.012
73817528|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.053||||||P-value is for HbA1c- at 6 weeks ≤6.5%.|Fisher Exact|||||||0.053
73817529|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.398||||||P-value is for HbA1c- at 12 weeks \<7.0%.|Fisher Exact|||||||0.398
73817530|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for HbA1c- at 12 weeks ≤6.5%.|Fisher Exact|||||||0.170
73817531|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.926||||||P-value is for HbA1c- at 24 weeks \<7.0%.|Fisher Exact|||||||0.926
73817532|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.824||||||P-value is for HbA1c- at 24 weeks ≤6.5%.|Fisher Exact|||||||0.824
73817533|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.385||||||P-value is for HbA1c- at 36 weeks \<7.0%.|Fisher Exact|||||||0.385
73817534|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.408||||||P-value is for HbA1c- at 36 weeks ≤6.5%.|Fisher Exact|||||||0.408
73817535|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.551||||||P-value is for HbA1c- at 52 weeks \<7.0%.|Fisher Exact|||||||0.551
73817536|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.9||||||P-value is for HbA1c- at 52 weeks ≤6.5%.|Fisher Exact|||||||0.900
73817537|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.646||||||P-value is for HbA1c- Endpoint, up to 24 weeks \<7.0%.|Fisher Exact|||||||0.646
73817538|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.661||||||P-value is for HbA1c- Endpoint, up to 24 weeks ≤6.5%.|Fisher Exact|||||||0.661
73817539|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.209||||||P-value is for HbA1c- Endpoint, up to 52 weeks \<7.0%.|Fisher Exact|||||||0.209
73817540|NCT01421147|147183417|SUPERIORITY_OR_OTHER|||||||0.54||||||P-value is for HbA1c- Endpoint, up to 52 weeks ≤6.5%.|Fisher Exact|||||||0.540
73817541|NCT01421147|147183418|SUPERIORITY_OR_OTHER|||||||0.703||||||P-value is for Total Events with BG ≤70 mg/dL,if available-24 wk.|Fisher Exact|||||||0.703
73817542|NCT01421147|147183418|SUPERIORITY_OR_OTHER|||||||0.495||||||P-value is for Total Events with BG ≤70 mg/dL,if available-52-wk.|Fisher Exact|||||||0.495
73817543|NCT01421147|147183418|SUPERIORITY_OR_OTHER|||||||0.174||||||P-value is for Severe Events-24 wk.|Fisher Exact|||||||0.174
73817544|NCT01421147|147183418|SUPERIORITY_OR_OTHER|||||||0.828||||||P-value is for Severe Events-52 wk.|Fisher Exact|||||||0.828
73817545|NCT01421147|147183418|SUPERIORITY_OR_OTHER|||||||0.661||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Fisher Exact|||||||0.661
73817546|NCT01421147|147183418|SUPERIORITY_OR_OTHER|||||||0.606||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Fisher Exact|||||||0.606
73817547|NCT01421147|147183419|SUPERIORITY_OR_OTHER|||||||0.717||||||P-value is for Total Events with BG ≤70 mg/dL, if available-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.717
73817548|NCT01421147|147183419|SUPERIORITY_OR_OTHER|||||||0.163||||||P-value is for Severe Events-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.163
73817549|NCT01421147|147183419|SUPERIORITY_OR_OTHER|||||||0.669||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.669
73817550|NCT01421147|147183419|SUPERIORITY_OR_OTHER|||||||0.738||||||P-value is for Total Events with BG ≤70 mg/dL, if available-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.738
73817551|NCT01421147|147183419|SUPERIORITY_OR_OTHER|||||||0.826||||||P-value is for Severe Events-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.826
73817552|NCT01421147|147183419|SUPERIORITY_OR_OTHER|||||||0.25||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.250
73817553|NCT02081014|147183442|SUPERIORITY_OR_OTHER||Point estimate ratio|0.62|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817554|NCT02081014|147183442|SUPERIORITY_OR_OTHER||Point estimate ratio|0.35|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817555|NCT02081014|147183442|SUPERIORITY_OR_OTHER||Point estimate ratio|0.57|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817556|NCT02081014|147183443|SUPERIORITY_OR_OTHER||Point estimate ratio|0.74|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817557|NCT02081014|147183443|SUPERIORITY_OR_OTHER||Point estimate ratio|0.44|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817558|NCT02081014|147183443|SUPERIORITY_OR_OTHER||Point estimate ratio|0.59|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817559|NCT02081014|147183444|SUPERIORITY_OR_OTHER||Point point ratio|0.68|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817560|NCT02081014|147183444|SUPERIORITY_OR_OTHER||Point estimate ratio|0.36|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817561|NCT02081014|147183444|SUPERIORITY_OR_OTHER||Point estimate ratio|0.53|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817562|NCT02081014|147183445|SUPERIORITY_OR_OTHER||Point estimate ratio|0.72|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817563|NCT02081014|147183445|SUPERIORITY_OR_OTHER||Point estimate ratio|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817564|NCT02081014|147183445|SUPERIORITY_OR_OTHER||Point estimate ratio|0.6|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817565|NCT02081014|147183446|SUPERIORITY_OR_OTHER||Point esimate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817566|NCT02081014|147183446|SUPERIORITY_OR_OTHER||Point estimate ratio|0.78|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817567|NCT02081014|147183446|SUPERIORITY_OR_OTHER||Point estimate ratio|0.79|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817568|NCT02081014|147183447|SUPERIORITY_OR_OTHER||Point estimate ratio|0.75|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817569|NCT02081014|147183447|SUPERIORITY_OR_OTHER||Point estimate ratio|0.73|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817570|NCT02081014|147183447|SUPERIORITY_OR_OTHER||Point estimate ratio|0.96|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817571|NCT02081014|147183448|SUPERIORITY_OR_OTHER||Point estimate ratio|0.82|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817572|NCT02081014|147183448|SUPERIORITY_OR_OTHER||Point estimate ratio|0.7|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817573|NCT02081014|147183448|SUPERIORITY_OR_OTHER||Point estimate ratio|0.85|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817574|NCT02081014|147183449|SUPERIORITY_OR_OTHER||Point estimate ratio|0.96|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817575|NCT02081014|147183449|SUPERIORITY_OR_OTHER||Point estimate ratio|0.83|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
73817576|NCT02081014|147183449|SUPERIORITY_OR_OTHER||Point estimate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817577|NCT02081014|147183450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3693.2|STANDARD_ERROR_OF_MEAN|1520.1|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
73817578|NCT02081014|147183450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7548.05|STANDARD_ERROR_OF_MEAN|1542.93||0.05|TWO_SIDED||||||Mixed Models Analysis|||||||0.05
73817579|NCT02081014|147183450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3854.86|STANDARD_ERROR_OF_MEAN|1533.95|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
73817580|NCT02081014|147183451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-144.9|STANDARD_ERROR_OF_MEAN|741.24|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>0.05
73817581|NCT02081014|147183451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1665.32|STANDARD_ERROR_OF_MEAN|696.97|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
73817582|NCT02081014|147183451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1520.39|STANDARD_ERROR_OF_MEAN|700.92|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>0.05
73817583|NCT02081014|147183452|SUPERIORITY_OR_OTHER||Point estimate ratio|0.41|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817584|NCT02081014|147183452|SUPERIORITY_OR_OTHER||Point estimate ratio|0.43|STANDARD_ERROR_OF_MEAN|0.34|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817585|NCT02081014|147183452|SUPERIORITY_OR_OTHER||Point estimate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.81|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817586|NCT02081014|147183453|SUPERIORITY_OR_OTHER||Point estimate ratio|0.23|STANDARD_ERROR_OF_MEAN|0.29|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817587|NCT02081014|147183453|SUPERIORITY_OR_OTHER||Point estimate ratio|0.73|STANDARD_ERROR_OF_MEAN|0.88|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
73817588|NCT02081014|147183453|SUPERIORITY_OR_OTHER||Point estimate ratio|3.23|STANDARD_ERROR_OF_MEAN|3.84|>|0.05|TWO_SIDED||||||Regression, Linear||Geometric means|||||>0.05
73817589|NCT03543176|147183461|OTHER|||||||0.448||||||P-value for low impact of COPD is presented|Fisher Exact|||||||0.448
73817590|NCT03543176|147183461|OTHER|||||||0.033||||||P-value for medium impact of COPD is presented|Fisher Exact|||||||0.033
73817591|NCT03543176|147183461|OTHER|||||||0.172||||||P-value for high impact of COPD is presented|Fisher Exact|||||||0.172
73817592|NCT03543176|147183461|OTHER|||||||0.01||||||P-value for very high impact of COPD is presented|Fisher Exact|||||||0.010
73817593|NCT03543176|147183462|OTHER|||||||0.176||||||P-value for breathlessness reported in COPD assessed using mMRC is presented|Fisher Exact|||||||0.176
73817594|NCT03543176|147183463|OTHER|||||||0.732||||||P-value for Baseline comorbidity burden score was calculated.|t-test, 2 sided|||||||0.732
73817595|NCT03543176|147183464|OTHER|||||||0.013||||||P-value for count of unique medications was calculated.|t-test, 2 sided|||||||0.013
73817596|NCT03543176|147183465|OTHER|||||||0.178||||||P-value for total number of medications dispensing was calculated.|t-test, 2 sided|||||||0.178
73817597|NCT03543176|147183471|OTHER|||||||0.692||||||P-value for count of unique COPD medications was calculated|t-test, 2 sided|||||||0.692
73817598|NCT03543176|147183472|OTHER||||||<|0.001||||||P-value for total number of COPD medications dispensing was calculated|t-test, 2 sided|||||||<0.001
73817599|NCT03300050|147183512|OTHER||GMT Ratio|2.73|||<|0.0001|TWO_SIDED|95.0|1.73|4.29|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted Geometric Mean Titer (GMT) Ratio 28 Days Post-Boost Dose||4.29|1.73|<0.0001
73817600|NCT03300050|147183512|OTHER||GMT Ratio|1.06||||0.9411|TWO_SIDED|95.0|0.68|1.66|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.66|0.68|0.9411
73817601|NCT03300050|147183512|OTHER||GMT Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.24|0.62|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||0.62|0.24|<0.0001
73817602|NCT03300050|147183513|OTHER||Difference|59.6||||0.0025|TWO_SIDED|95.0|23.59|81.02|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||81.02|23.59|0.0025
73817603|NCT03300050|147183513|OTHER||Difference|17.9||||0.4421|TWO_SIDED|95.0|-16.24|49.0|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||49.00|-16.24|0.4421
73817604|NCT03300050|147183513|OTHER||Difference|-41.8||||0.0461|TWO_SIDED|95.0|-68.75|-4.8|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||-4.80|-68.75|0.0461
73817605|NCT03300050|147183517|OTHER||GMT Ratio|1.71||||0.1665|TWO_SIDED|95.0|0.84|3.48|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.48|0.84|0.1665
73817606|NCT03300050|147183517|OTHER||GMT Ratio|1.1||||0.9377|TWO_SIDED|95.0|0.55|2.2|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.20|0.55|0.9377
73817607|NCT03300050|147183517|OTHER||GMT Ratio|0.64||||0.3088|TWO_SIDED|95.0|0.31|1.33|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.33|0.31|0.3088
73817608|NCT03300050|147183518|OTHER||Difference|16.3||||0.4667|TWO_SIDED|95.0|-19.85|48.88|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||48.88|-19.85|0.4667
73817609|NCT03300050|147183518|OTHER||Difference|-1.8|||>|0.9999|TWO_SIDED|95.0|-34.76|32.17|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||32.17|-34.76|>0.9999
73817610|NCT03300050|147183518|OTHER||Difference|-18.1||||0.4495|TWO_SIDED|95.0|-51.15|19.37|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||19.37|-51.15|0.4495
73817611|NCT03300050|147183522|OTHER||GMT Ratio|1.61||||0.0928|TWO_SIDED|95.0|0.94|2.77|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.77|0.94|0.0928
73817612|NCT03300050|147183522|OTHER||GMT Ratio|1.32||||0.4198|TWO_SIDED|95.0|0.77|2.26|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.26|0.77|0.4198
73817613|NCT03300050|147183522|OTHER||GMT Ratio|0.82||||0.6754|TWO_SIDED|95.0|0.47|1.45|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.45|0.47|0.6754
73817614|NCT03300050|147183523|OTHER||Difference|19.2||||0.4515|TWO_SIDED|95.0|-17.19|50.49|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||50.49|-17.19|0.4515
73817615|NCT03300050|147183523|OTHER||Difference|14.3||||0.4837|TWO_SIDED|95.0|-21.22|46.19|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||46.19|-21.22|0.4837
73817616|NCT03300050|147183523|OTHER||Difference|-4.9|||>|0.9999|TWO_SIDED|95.0|-38.8|30.46|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||30.46|-38.80|>0.9999
73817617|NCT03300050|147183526|OTHER||Difference|2.93||||0.0031|TWO_SIDED|95.0|1.56|7.49|||Wilcoxon (Mann-Whitney)||Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||7.49|1.56|0.0031
73817618|NCT03300050|147183526|OTHER||Difference|1.25||||0.2048|TWO_SIDED|95.0|0.73|2.23|||Wilcoxon (Mann-Whitney)||Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||2.23|0.73|0.2048
73817619|NCT03300050|147183526|OTHER||Difference|0.43||||0.0392|TWO_SIDED|95.0|0.18|1.0|||Wilcoxon (Mann-Whitney)|||Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||1.00|0.18|0.0392
73817620|NCT03300050|147183527|OTHER||Difference|1.16||||0.8243|TWO_SIDED|95.0|0.14|4.95|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||4.95|0.14|0.8243
73817621|NCT03300050|147183527|OTHER||Difference|1.74||||0.253|TWO_SIDED|95.0|0.67|6.06|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||6.06|0.67|0.2530
73817622|NCT03300050|147183527|OTHER||Difference|1.83||||0.5654|TWO_SIDED|95.0|0.47|39.92|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||39.92|0.47|0.5654
73817623|NCT03300050|147183531|OTHER||GMT Ratio|1.21||||0.883|TWO_SIDED|95.0|0.45|3.27|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.27|0.45|0.8830
73817624|NCT03300050|147183531|OTHER||GMT Ratio|0.86||||0.9238|TWO_SIDED|95.0|0.33|2.26|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.26|0.33|0.9238
73817625|NCT03300050|147183531|OTHER||GMT Ratio|0.71||||0.6926|TWO_SIDED|95.0|0.26|1.97|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.97|0.26|0.6926
73817626|NCT03300050|147183532|OTHER||Difference|11.7||||0.7036|TWO_SIDED|95.0|-25.72|45.82|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||45.82|-25.72|0.7036
73817627|NCT03300050|147183532|OTHER||Difference|-3.8|||>|0.9999|TWO_SIDED|95.0|-37.9|31.31|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||31.31|-37.90|>0.9999
73817628|NCT03300050|147183532|OTHER||Difference|-15.5||||0.6951|TWO_SIDED|95.0|-49.56|22.79|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||22.79|-49.56|0.6951
73817629|NCT03300050|147183536|OTHER||GMT Ratio|0.65||||0.3203|TWO_SIDED|95.0|0.32|1.33|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||1.33|0.32|0.3203
73817630|NCT03300050|147183536|OTHER||GMT Ratio|0.72||||0.5009|TWO_SIDED|95.0|0.35|1.47|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||1.47|0.35|0.5009
73817631|NCT03300050|147183536|OTHER||GMT Ratio|1.1||||0.9542|TWO_SIDED|95.0|0.51|2.37|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||2.37|0.51|0.9542
73817632|NCT03300050|147183537|OTHER||Difference|-1.7|||>|0.9999|TWO_SIDED|95.0|-30.62|23.79|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||23.79|-30.62|>0.9999
73817633|NCT03300050|147183537|OTHER||Difference|6.7|||>|0.9999|TWO_SIDED|95.0|-16.24|30.34|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||30.34|-16.24|>0.9999
73817634|NCT03300050|147183537|OTHER||Difference|8.3||||0.4615|TWO_SIDED|95.0|-19.94|36.04|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||36.04|-19.94|0.4615
73817635|NCT03300050|147183541|OTHER||GMT Ratio|1.2||||0.9164|TWO_SIDED|95.0|0.38|3.8|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.80|0.38|0.9164
73817636|NCT03300050|147183541|OTHER||GMT Ratio|0.76||||0.8642|TWO_SIDED|95.0|0.21|2.79|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.79|0.21|0.8642
73817637|NCT03300050|147183541|OTHER||GMT Ratio|0.63||||0.6545|TWO_SIDED|95.0|0.18|2.27|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.27|0.18|0.6545
73817638|NCT03300050|147183542|OTHER||Difference|7.7|||>|0.9999|TWO_SIDED|95.0|-27.1|40.96|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||40.96|-27.10|>0.9999
73817639|NCT03300050|147183542|OTHER||Difference|30.8||||0.1045|TWO_SIDED|95.0|-1.76|58.19|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||58.19|-1.76|0.1045
73817640|NCT03300050|147183542|OTHER||Difference|23.1||||0.2292|TWO_SIDED|95.0|-8.62|50.86|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||50.86|-8.62|0.2292
73817641|NCT02178358|147183597|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.837|TWO_SIDED|95.0|0.434|1.226|||Bayesian exponential-likelihood model|||||1.226|0.434|0.837
73817642|NCT02178358|147183597|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.704|TWO_SIDED|95.0|0.633|1.266|||Bayesian exponential-likelihood model|||||1.266|0.633|0.704
73817643|NCT00560703|147183631|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power calculation for this endpoint was driven by the assumptions made for the OSDI analysis||||||0.578||95.0|||||ANCOVA|||||||0.578
73817644|NCT00560703|147183632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293||95.0|||||ANCOVA|||It was anticipated that the difference between the treatment groups in mean reduction from baseline in OSDI scores will be approximately 7 points. A pooled standard deviation of 9.0 for the mean change from baseline OSDI score is expected. Under those assumptions a total of approximately 63 evaluable patients (42 COL-101 patients and 21 placebo patients) is sufficient to provide 80% power. The planned enrolment should provide enough evaluable patients to meet these assumptions.||||0.293
73817645|NCT00482170|147183659|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test was performed using the 95 percent (%) confidence interval (CI) of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|0.87|1.77||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||Analysis of variance (ANOVA) using mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||1.77|0.87|<0.001
73817646|NCT00482170|147183660|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test was performed using the 95% CI of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.41|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|0.95|1.87||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||ANOVA using a mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||1.87|0.95|<0.001
73817647|NCT00482170|147183661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.12||||0.008|TWO_SIDED|95.0|2.05|126.9||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: Generalized Estimating Equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||126.9|2.05|0.008
73817648|NCT00482170|147183661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.25||||0.002|TWO_SIDED|95.0|2.44|51.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||51.83|2.44|0.002
73817649|NCT00482170|147183661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.88||||0.001|TWO_SIDED|95.0|2.26|27.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||27.44|2.26|0.001
73817650|NCT00482170|147183661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.73|||<|0.001|TWO_SIDED|95.0|2.59|29.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used for the analysis.||29.47|2.59|<0.001
73817651|NCT00482170|147183662|SUPERIORITY_OR_OTHER||Regression coefficient|0.17||||0.045|TWO_SIDED|95.0|0.0|0.34||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.34|0.00|0.045
73817652|NCT00482170|147183663|SUPERIORITY_OR_OTHER||Regression coefficient|-0.09||||0.707|TWO_SIDED|95.0|-0.58|0.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, female and male (reference).||0.39|-0.58|0.707
73817653|NCT00482170|147183664|SUPERIORITY_OR_OTHER||Regression coefficient|-0.38||||0.195|TWO_SIDED|95.0|-0.89|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, high school or baccalaureate level and reading or writing capacity (reference).||0.14|-0.89|0.195
73817654|NCT00482170|147183664|SUPERIORITY_OR_OTHER||Regression coefficient|-0.55||||0.195|TWO_SIDED|95.0|-1.21|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, university level and reading or writing capacity (reference).||0.11|-1.21|0.195
73817655|NCT00482170|147183665|SUPERIORITY_OR_OTHER||Regression coefficient|-0.09||||0.493|TWO_SIDED|95.0|-0.36|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-A: =\< 4, HAD-A: \> 4 to 7, HAD-A: \> 7 to 10 and HAD-A: \> 10; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.17|-0.36|0.493
73817656|NCT00482170|147183665|SUPERIORITY_OR_OTHER||Regression coefficient|-0.16||||0.287|TWO_SIDED|95.0|-0.46|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-D: =\< 3, HAD-D: \> 3 to 5, HAD-D: \> 5 to 8 and HAD-A: \> 8; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.14|-0.46|0.287
73817657|NCT00482170|147183666|SUPERIORITY_OR_OTHER||Regression coefficient|0.13||||0.123|TWO_SIDED|95.0|-0.04|0.3||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.30|-0.04|0.123
73817658|NCT00482170|147183667|SUPERIORITY_OR_OTHER||Regression coefficient|-0.24||||0.359|TWO_SIDED|95.0|-0.76|0.28||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||0.28|-0.76|0.359
73817659|NCT00482170|147183668|SUPERIORITY_OR_OTHER||Regression coefficient|0.02||||0.693|TWO_SIDED|95.0|-0.08|0.12|||Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.12|-0.08|0.693
73817660|NCT00482170|147183669|SUPERIORITY_OR_OTHER||Regression coefficient|0.22||||0.17|TWO_SIDED|95.0|-0.09|0.53||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.53|-0.09|0.170
73817661|NCT00482170|147183670|SUPERIORITY_OR_OTHER||Regression coefficient|0.02||||0.211|TWO_SIDED|95.0|-0.01|0.04||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.04|-0.01|0.211
73817662|NCT00482170|147183671|SUPERIORITY_OR_OTHER||Regression coefficient|0.09||||0.045|TWO_SIDED|95.0|0.0|0.18||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.18|0.00|0.045
73817663|NCT00482170|147183672|SUPERIORITY_OR_OTHER||Regression coefficient|-0.01||||0.913|TWO_SIDED|95.0|-0.12|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.11|-0.12|0.913
73817664|NCT00482170|147183673|SUPERIORITY_OR_OTHER||Regression coefficient|0.0||||0.968|TWO_SIDED|95.0|-0.17|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.17|-0.17|0.968
73817665|NCT00482170|147183674|SUPERIORITY_OR_OTHER||Regression coefficient|-0.15||||0.531|TWO_SIDED|95.0|-0.61|0.32||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current tobacco usage: yes and current tobacco usage: no (reference).||0.32|-0.61|0.531
73817666|NCT00482170|147183674|SUPERIORITY_OR_OTHER||Regression coefficient|0.44||||0.061|TWO_SIDED|95.0|-0.02|0.9||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current alcohol usage: yes and current alcohol usage: no (reference).||0.90|-0.02|0.061
73817667|NCT00482170|147183675|SUPERIORITY_OR_OTHER||Regression coefficient|-0.73||||0.759|TWO_SIDED|95.0|-5.37|3.92||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||3.92|-5.37|0.759
73817668|NCT00482170|147183676|SUPERIORITY_OR_OTHER||Regression coefficient|0.09||||0.713|TWO_SIDED|95.0|-0.37|0.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||0.55|-0.37|0.713
73817669|NCT00482170|147183677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.001|TWO_SIDED|95.0|1.63|3.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.49|1.63|<0.001
73817670|NCT00482170|147183677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.61|3.67||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4:A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.67|1.61|<0.001
73817671|NCT00482170|147183677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74|||<|0.001|TWO_SIDED|95.0|1.78|4.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.21|1.78|<0.001
73817672|NCT00482170|147183677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.66|3.8||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.80|1.66|<0.001
73817673|NCT00482170|147183678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.004|TWO_SIDED|95.0|1.22|2.89||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.89|1.22|0.004
73817674|NCT00482170|147183678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.017|TWO_SIDED|95.0|1.1|2.72||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.72|1.10|0.017
73817675|NCT00482170|147183678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.47|3.73||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.73|1.47|<0.001
73817676|NCT00482170|147183678|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.001|TWO_SIDED|95.0|1.32|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.21|1.32|0.001
73817677|NCT00482170|147183679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.025|TWO_SIDED|95.0|1.07|2.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.64|1.07|0.025
73817678|NCT00482170|147183679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.936|TWO_SIDED|95.0|0.63|1.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.64|0.63|0.936
73817679|NCT00482170|147183679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.42|TWO_SIDED|95.0|0.75|1.99||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.99|0.75|0.420
73817680|NCT00482170|147183679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.625|TWO_SIDED|95.0|0.71|1.79||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.79|0.71|0.625
73817681|NCT00482170|147183680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.21|TWO_SIDED|95.0|0.86|1.94||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.94|0.86|0.210
73817682|NCT00482170|147183680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.227|TWO_SIDED|95.0|0.85|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.85|0.227
73817683|NCT00482170|147183680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.22|TWO_SIDED|95.0|0.84|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.08|0.84|0.220
73817684|NCT00482170|147183680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.249|TWO_SIDED|95.0|0.84|2.0||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.00|0.84|0.249
73817685|NCT00482170|147183681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.48|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.21|1.48|<0.001
73817686|NCT00482170|147183681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.62|3.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.62|1.62|<0.001
73817687|NCT00482170|147183681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35|||<|0.001|TWO_SIDED|95.0|1.58|3.51||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.51|1.58|<0.001
73817688|NCT00482170|147183681|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.64|3.59||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.59|1.64|<0.001
73817689|NCT00482170|147183682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.5|3.65||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.65|1.50|<0.001
73817690|NCT00482170|147183682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001|TWO_SIDED|95.0|1.83|4.77||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.77|1.83|<0.001
73817691|NCT00482170|147183682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58|||<|0.001|TWO_SIDED|95.0|1.62|4.12||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.12|1.62|<0.001
73817692|NCT00482170|147183682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45|||<|0.001|TWO_SIDED|95.0|1.55|3.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.86|1.55|<0.001
73817693|NCT00482170|147183683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.681|TWO_SIDED|95.0|0.73|1.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.62|0.73|0.681
73817694|NCT00482170|147183683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.947|TWO_SIDED|95.0|0.67|1.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.54|0.67|0.947
73817695|NCT00482170|147183683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.604|TWO_SIDED|95.0|0.59|1.36||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.36|0.59|0.604
73817696|NCT00482170|147183683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.43|TWO_SIDED|95.0|0.57|1.27||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.27|0.57|0.430
73817697|NCT00482170|147183684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.072|TWO_SIDED|95.0|0.48|1.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.03|0.48|0.072
73817698|NCT00482170|147183684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.205|TWO_SIDED|95.0|0.86|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.86|0.205
73817699|NCT00482170|147183684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.434|TWO_SIDED|95.0|0.78|1.78||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.78|0.78|0.434
73817700|NCT00482170|147183684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.857|TWO_SIDED|95.0|0.69|1.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.55|0.69|0.857
73817701|NCT00482170|147183685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.837|TWO_SIDED|95.0|0.7|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.56|0.70|0.837
73817702|NCT00482170|147183685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.172|TWO_SIDED|95.0|0.87|2.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.15|0.87|0.172
73817703|NCT00482170|147183685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.096|TWO_SIDED|95.0|0.94|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.24|0.94|0.096
73817704|NCT00482170|147183685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.164|TWO_SIDED|95.0|0.88|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.08|0.88|0.164
73817705|NCT00482170|147183686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.356|TWO_SIDED|95.0|0.83|1.69||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.69|0.83|0.356
73817706|NCT00482170|147183686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.737|TWO_SIDED|95.0|0.73|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.56|0.73|0.737
73817707|NCT00482170|147183686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.156|TWO_SIDED|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.91|0.90|0.156
73817708|NCT00482170|147183686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.29|TWO_SIDED|95.0|0.85|1.76||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.76|0.85|0.290
73817709|NCT00482170|147183687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.065|TWO_SIDED|95.0|0.5|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.02|0.50|0.065
73817710|NCT00482170|147183687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.1|TWO_SIDED|95.0|0.5|1.06||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.06|0.50|0.100
73817711|NCT00482170|147183687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.298|TWO_SIDED|95.0|0.54|1.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.21|0.54|0.298
73817712|NCT00482170|147183687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.148|TWO_SIDED|95.0|0.51|1.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.11|0.51|0.148
73817713|NCT00482170|147183688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.098|TWO_SIDED|95.0|0.94|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.94|0.098
73817714|NCT00482170|147183688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.311|TWO_SIDED|95.0|0.82|1.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.87|0.82|0.311
73817715|NCT00482170|147183688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.376|TWO_SIDED|95.0|0.79|1.85||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.85|0.79|0.376
73817716|NCT00482170|147183688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.299|TWO_SIDED|95.0|0.83|1.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.86|0.83|0.299
73817717|NCT00482170|147183689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.494|TWO_SIDED|95.0|0.6|1.28||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.28|0.60|0.494
73817718|NCT00482170|147183689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.036|TWO_SIDED|95.0|0.44|0.97||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.97|0.44|0.036
73817719|NCT00482170|147183689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.079|TWO_SIDED|95.0|0.45|1.04||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.04|0.45|0.079
73817720|NCT00482170|147183689|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.063|TWO_SIDED|95.0|0.46|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.02|0.46|0.063
73817721|NCT00482170|147183690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.628|TWO_SIDED|95.0|0.62|1.33||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.33|0.62|0.628
73817722|NCT00482170|147183690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.203|TWO_SIDED|95.0|0.51|1.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.15|0.51|0.203
73817723|NCT00482170|147183690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.222|TWO_SIDED|95.0|0.51|1.17||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.17|0.51|0.222
73817724|NCT00482170|147183690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.263|TWO_SIDED|95.0|0.53|1.19||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.19|0.53|0.263
73817725|NCT00482170|147183691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.914|TWO_SIDED|95.0|0.7|1.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.50|0.70|0.914
73817726|NCT00482170|147183691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.827|TWO_SIDED|95.0|0.7|1.57||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.57|0.70|0.827
73817727|NCT00482170|147183691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.712|TWO_SIDED|95.0|0.61|1.4||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.40|0.61|0.712
73817728|NCT00482170|147183691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.733|TWO_SIDED|95.0|0.62|1.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.39|0.62|0.733
73817729|NCT00482170|147183692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.95||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.95|0.95|0.090
73817730|NCT00482170|147183692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.154|TWO_SIDED|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.91|0.90|0.154
73817731|NCT00482170|147183692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.037|TWO_SIDED|95.0|1.02|2.22||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.22|1.02|0.037
73817732|NCT00482170|147183692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.028|TWO_SIDED|95.0|1.05|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.24|1.05|0.028
73817733|NCT00482170|147183693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.022|TWO_SIDED|95.0|1.06|2.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.21|1.06|0.022
73817734|NCT00482170|147183693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.005|TWO_SIDED|95.0|1.17|2.41||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.41|1.17|0.005
73817735|NCT00482170|147183693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.076|TWO_SIDED|95.0|0.97|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.97|0.076
73817736|NCT00482170|147183693|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.049|TWO_SIDED|95.0|1.0|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.11|1.00|0.049
73817737|NCT00482170|147183694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||<|0.001|TWO_SIDED|95.0|1.32|2.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.83|1.32|<0.001
73817738|NCT00482170|147183694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||<|0.001|TWO_SIDED|95.0|1.78|3.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.87|1.78|<0.001
73817739|NCT00482170|147183694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.42|3.19||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.19|1.42|<0.001
73817740|NCT00482170|147183694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.001|TWO_SIDED|95.0|1.52|3.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.39|1.52|<0.001
73817741|NCT00482170|147183695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.057|TWO_SIDED|95.0|0.99|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.11|0.99|0.057
73817742|NCT00482170|147183695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.151|TWO_SIDED|95.0|0.9|1.96||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.96|0.90|0.151
73817743|NCT00482170|147183695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.024|TWO_SIDED|95.0|1.06|2.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.44|1.06|0.024
73817744|NCT00482170|147183695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.025|TWO_SIDED|95.0|1.06|2.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.39|1.06|0.025
73817745|NCT00482170|147183696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.24|0.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.49|0.24|<0.001
73817746|NCT00482170|147183696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26|||<|0.001|TWO_SIDED|95.0|0.18|0.37||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.37|0.18|<0.001
73817747|NCT00482170|147183696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||<|0.001|TWO_SIDED|95.0|0.21|0.45||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.45|0.21|<0.001
73817748|NCT00482170|147183696|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32|||<|0.001|TWO_SIDED|95.0|0.23|0.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.47|0.23|<0.001
73817749|NCT00482170|147183697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38|||<|0.001|TWO_SIDED|95.0|0.27|0.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.54|0.27|<0.001
73817750|NCT00482170|147183697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||<|0.001|TWO_SIDED|95.0|0.21|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.21|<0.001
73817751|NCT00482170|147183697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.50|0.24|<0.001
73817752|NCT00482170|147183697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||<|0.001|TWO_SIDED|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.50|0.24|<0.001
73817753|NCT00482170|147183698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33|||<|0.001|TWO_SIDED|95.0|0.24|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.24|<0.001
73817754|NCT00482170|147183698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32|||<|0.001|TWO_SIDED|95.0|0.22|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.22|<0.001
73817755|NCT00482170|147183698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38|||<|0.001|TWO_SIDED|95.0|0.26|0.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.56|0.26|<0.001
73817756|NCT00482170|147183698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41|||<|0.001|TWO_SIDED|95.0|0.28|0.58||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.58|0.28|<0.001
73817757|NCT00482170|147183699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.47|TWO_SIDED|95.0|0.6|1.26||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the first injection: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.26|0.60|0.470
73817758|NCT00482170|147183699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.325|TWO_SIDED|95.0|0.57|1.2||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.20|0.57|0.325
73817759|NCT00482170|147183699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.197|TWO_SIDED|95.0|0.55|1.13||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.13|0.55|0.197
73817760|NCT00482170|147183699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.212|TWO_SIDED|95.0|0.56|1.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.14|0.56|0.212
73817761|NCT00482170|147183700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.35||0.515|TWO_SIDED|95.0|-0.91|0.46||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Baseline- after the training: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an auto-regressive correlation structure was used to calculate 95% CI.||0.46|-0.91|0.515
73817762|NCT00482170|147183700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.34||0.842|TWO_SIDED|95.0|-0.74|0.6||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 4: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||0.60|-0.74|0.842
73817763|NCT00482170|147183700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.33||0.928|TWO_SIDED|95.0|-0.67|0.61||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 12: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||0.61|-0.67|0.928
73817764|NCT00482170|147183700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.32||0.974|TWO_SIDED|95.0|-0.62|0.64||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Last observation: ANOVA method was used for the analysis.||0.64|-0.62|0.974
73817765|NCT00482170|147183701|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated using ANOVA.||||0.030
73817766|NCT00482170|147183701|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated using ANOVA.||||0.010
73817767|NCT00482170|147183702|SUPERIORITY_OR_OTHER|||||||0.984||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.984
73817768|NCT00482170|147183702|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.549
73817769|NCT00482170|147183703|SUPERIORITY_OR_OTHER|||||||0.158||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.158
73817770|NCT00482170|147183703|SUPERIORITY_OR_OTHER|||||||0.808||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.808
73817771|NCT00482170|147183704|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg auto-injector group was calculated.||||0.029
73817772|NCT00482170|147183704|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg prefilled syringe group was calculated.||||0.005
73817773|NCT00482170|147183704|SUPERIORITY_OR_OTHER|||||||0.411||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg auto-injector group was calculated.||||0.411
73817774|NCT00482170|147183704|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg prefilled syringe group was calculated.||||0.005
73817775|NCT00482170|147183705|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.039
73817776|NCT00482170|147183705|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.006
73817777|NCT00482170|147183706|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.752
73817778|NCT00482170|147183706|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.700
73817779|NCT00482170|147183707|SUPERIORITY_OR_OTHER|||||||0.697||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.697
73817780|NCT00482170|147183707|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.159
73817781|NCT00482170|147183708|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.004
73817782|NCT00482170|147183708|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.024
73817783|NCT00482170|147183709|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.652
73817784|NCT00482170|147183709|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.024
73817785|NCT00482170|147183710|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.560
73817786|NCT00482170|147183710|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.474
73817787|NCT00482170|147183711|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.023
73817788|NCT00482170|147183711|SUPERIORITY_OR_OTHER|||||||0.089||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.089
73817789|NCT00482170|147183712|SUPERIORITY_OR_OTHER|||||||0.494||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.494
73817790|NCT00482170|147183712|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.782
73817791|NCT00482170|147183713|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.444
73817792|NCT00482170|147183713|SUPERIORITY_OR_OTHER|||||||0.947||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.947
73817793|NCT00482170|147183714|SUPERIORITY_OR_OTHER|||||||0.787||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg auto-injector group was calculated.||||0.787
73817794|NCT00482170|147183714|SUPERIORITY_OR_OTHER|||||||0.379||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg prefilled syringe group was calculated.||||0.379
73817795|NCT00482170|147183714|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg auto-injector group was calculated.||||0.098
73817796|NCT00482170|147183714|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg prefilled syringe group was calculated.||||0.166
73817797|NCT00482170|147183715|SUPERIORITY_OR_OTHER|||||||0.535||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.535
73817798|NCT03585712|147183732|OTHER|Is the overall mean change from baseline different from zero? Or did the infringement of schedule regardless the type of infringement lead to a change in mucus score?||||||0.26||||||P value from model testing intercept (does infringement change mucus score?) P-value from a repeated measures mixed model with the period, intervention, sequence and time (visit) as covariates. P-values ≤0.050 are considered significant|Mixed Models Analysis|||"Mixed model for repeated measures using as response delta to Day41, delta to Day42, delta to Day70 and delta to Day71.~Covariates: period, intervention (missed pill or delayed pill), sequence of intervention (missed pill then delayed pill and vice versa), time and subject.~Subject as random effect + time repeated effect within each combination subject\* period"||||0.26
73817799|NCT03585712|147183733|OTHER||||||>|0.999||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Absence of risk increase||||>0.999
73817800|NCT03585712|147183733|OTHER|||||||0.655||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Transient risk increase||||0.655
73817801|NCT03585712|147183733|OTHER|||||||0.317||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Prolonged risk increase||||0.317
73817802|NCT03585712|147183734|OTHER||||||<|0.001||||||Indicates significance at the 0.05 level (p-value ≤ 0.05)|McNemar|P-value from an exact kappa test comparing agreement of ovarian status vs the reported perfect use period||A stratified McNemar test (stratification on the site, AGREE option in SAS) was used to compare the distribution of ovarian activity classification in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use). The worst (meaning most risk of ovulation) ovarian activity category in the period was used for the analyses.||||<0.001
73817803|NCT03585712|147183734|OTHER||||||<|0.001||||||Indicates significance at the 0.05 level (p-value ≤ 0.05)|McNemar|P-value from an exact kappa test comparing agreement of ovarian status vs the reported perfect use period.||A stratified McNemar test (stratification on the site, AGREE option in SAS) was used to compare the distribution of ovarian activity classification in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use). The worst (meaning most risk of ovulation) ovarian activity category in the period was used for the analyses.||||<0.001
73817804|NCT03585712|147183735|OTHER|||||||0.127|||||||McNemar|P-value from an exact kappa test comparing agreement of cervical mucus score classification vs the reported perfect use period||Stratified McNemar test (stratification on the site, AGREE option in SAS) to compare the distribution of cervical mucus scores in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use).||||0.127
73817805|NCT03585712|147183735|OTHER|||||||0.018||||||\* Indicates significance at the 0.05 level (p-value ≤ 0.05).|McNemar|P-value from an exact kappa test comparing agreement of cervical mucus score classification vs the reported perfect use period.||Stratified McNemar test (stratification on the site, AGREE option in SAS) to compare the distribution of cervical mucus scores in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use).||||0.018
73817806|NCT03004924|147183747|SUPERIORITY||Difference in response rate|7.7||||0.127|TWO_SIDED|95.0|-1.6|16.9|||Fisher Exact|||||16.9|-1.6|0.127
73817807|NCT03004924|147183748|SUPERIORITY||Difference in response rate|-3.5||||0.5|TWO_SIDED|95.0|-12.8|5.9|||Fisher Exact|||||5.9|-12.8|0.500
73817808|NCT04677387|147183766|SUPERIORITY||Mean Difference (Final Values)|-0.00325||||0.473|TWO_SIDED||||||Regression, Linear|Linear regression using a Generalized Estimating Equation (GEE) model clustering on pharmacy.||||||0.473
73817809|NCT04677387|147183767|SUPERIORITY|||||||0.007|||||||Regression, Linear|Linear regression with Generalized Estimating Equation (GEE) model.||||||.007
73817810|NCT04677387|147183768|SUPERIORITY|||||||0.002|||||||Regression, Linear|Linear regression with a Generalized Estimating Equation (GEE) model.||||||.002
73817811|NCT04677387|147183769|SUPERIORITY|||||||0.169|||||||Regression, Linear|Linear regression with Generalized Estimating Equation (GEE) model.||||||0.169
73817812|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-3.4|1.2||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.2|-3.4|
73817813|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-3.7|1.6||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.6|-3.7|
73817814|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-2.3|2.4||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.4|-2.3|
73817815|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||TWO_SIDED|97.5|-5.4|2.8||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-5.4|
73817816|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||TWO_SIDED|97.5|-5.3|2.6||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.6|-5.3|
73817817|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-4.7|4.7||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.7|-4.7|
73817818|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||TWO_SIDED|97.5|-2.7|1.6||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.6|-2.7|
73817819|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||TWO_SIDED|97.5|-3.8|2.8||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-3.8|
73817820|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-4.3|2.5||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.5|-4.3|
73817821|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|1.2|||||TWO_SIDED|97.5|-1.6|4.5||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.5|-1.6|
73817822|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.8|||||TWO_SIDED|97.5|-1.6|3.6||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||3.6|-1.6|
73817823|NCT01964716|147183782|SUPERIORITY_OR_OTHER||percentage difference|-0.4|||||TWO_SIDED|97.5|-4.4|3.5||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan \& Zhang) for the difference in proportions, 13vPnC multidose vial (MDV) - 13vPnC single-dose syringe (SDS), expressed as a percentage was analyzed.||3.5|-4.4|
73817824|NCT01964716|147183782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-4.3|4.4||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.4|-4.3|
73817825|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.87|1.22||||||Serotype 1: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.87|
73817826|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.79|||||TWO_SIDED|97.5|0.71|0.9||||||Serotype 3: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||0.90|0.71|
73817827|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.0|||||TWO_SIDED|97.5|0.86|1.18||||||Serotype 4: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.18|0.86|
73817828|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||TWO_SIDED|97.5|0.85|1.19||||||Serotype 5: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.19|0.85|
73817829|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.86|1.22||||||Serotype 6A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.86|
73817830|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.06|||||TWO_SIDED|97.5|0.82|1.36||||||Serotype 6B: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.36|0.82|
73817831|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.94|||||TWO_SIDED|97.5|0.82|1.08||||||Serotype 7F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.08|0.82|
73817832|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.87|1.21||||||Serotype 9V: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.21|0.87|
73817833|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.96|||||TWO_SIDED|97.5|0.75|1.24||||||Serotype 14: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.24|0.75|
73817834|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.28|||||TWO_SIDED|97.5|1.09|1.49||||||Serotype 18C: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.49|1.09|
73817835|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||TWO_SIDED|97.5|0.82|1.24||||||Serotype 19A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.24|0.82|
73817836|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.04|||||TWO_SIDED|97.5|0.85|1.26||||||Serotype 19F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.26|0.85|
73817837|NCT01964716|147183783|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.2|||||TWO_SIDED|97.5|0.98|1.48||||||Serotype 23F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.48|0.98|
73817838|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|-7.7|||||TWO_SIDED|95.0|-17.2|1.9||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.9|-17.2|
73817839|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|-1.2|||||TWO_SIDED|95.0|-4.4|1.1||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.1|-4.4|
73817840|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.3|2.3||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.3|-2.3|
73817841|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|-2.4|||||TWO_SIDED|95.0|-10.6|5.7||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||5.7|-10.6|
73817842|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.9|2.8||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-2.9|
73817843|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.6|-4.5|
73817844|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.3|2.3||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.3|-2.3|
73817845|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|4.7|||||TWO_SIDED|95.0|-4.5|14.1||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||14.1|-4.5|
73817846|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|-7.8|||||TWO_SIDED|95.0|-15.8|0.0||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||-0.0|-15.8|
73817847|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.9|2.9||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.9|-2.9|
73817848|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|-1.9|||||TWO_SIDED|95.0|-6.6|2.4||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.4|-6.6|
73817849|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|-0.7|||||TWO_SIDED|95.0|-6.3|4.9||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.9|-6.3|
73817850|NCT01964716|147183792|SUPERIORITY_OR_OTHER||percent difference|-1.3|||||TWO_SIDED|95.0|-5.8|3.0||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||3.0|-5.8|
73817851|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.7|1.2||||||Serotype 1: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.20|0.70|
73817852|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.69|0.93||||||Serotype 3: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||0.93|0.69|
73817853|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.89|1.39||||||Serotype 4: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.39|0.89|
73817854|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.22||||||Serotype 5: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.80|
73817855|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.7|1.06||||||Serotype 6A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.06|0.70|
73817856|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.74|1.33||||||Serotype 6B: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.33|0.74|
73817857|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.7|1.0||||||Serotype 7F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.00|0.70|
73817858|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.79|1.27||||||Serotype 9V: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.27|0.79|
73817859|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.48|1.08||||||Serotype 14: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.08|0.48|
73817860|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|1.38|2.19||||||Serotype 18C: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||2.19|1.38|
73817861|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.16||||||Serotype 19A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.16|0.74|
73817862|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.71|1.18||||||Serotype 19F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.18|0.71|
73817863|NCT01964716|147183793|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.67|1.25||||||Serotype 23F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.25|0.67|
73817864|NCT01370616|147183812|NON_INFERIORITY_OR_EQUIVALENCE|If the 95% confidence interval for the estimated difference between the two groups has a lower bound greater than -15%, then ertapenem sodium will be considered at least as effective as piperacillin/tazobactam sodium.|Estimated Difference|-3.8|||||TWO_SIDED|95.0|-8.3|0.0|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||0.0|-8.3|
73817865|NCT01370616|147183813|SUPERIORITY_OR_OTHER||Estimated Difference|-1.7|||||TWO_SIDED|95.0|-5.5|1.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||1.8|-5.5|
73817866|NCT01370616|147183814|SUPERIORITY_OR_OTHER||Estimated Difference|-2.3|||||TWO_SIDED|95.0|-7.7|2.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||2.8|-7.7|
73817867|NCT01370616|147183815|SUPERIORITY_OR_OTHER||Estimated Difference|-4.1|||||TWO_SIDED|95.0|-11.9|3.4|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||3.4|-11.9|
73817868|NCT01370616|147183816|SUPERIORITY_OR_OTHER||Estimated Difference|-4.3|||||TWO_SIDED|95.0|-12.1|3.3|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||3.3|-12.1|
73817869|NCT01370616|147183817|SUPERIORITY_OR_OTHER||Estimated Difference|7.3|||||TWO_SIDED|95.0|-0.9|15.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||15.4|-0.9|
73817870|NCT01370616|147183818|SUPERIORITY_OR_OTHER||Estimated Difference|-2.5|||||TWO_SIDED|95.0|-8.5|3.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||3.4|-8.5|
73817871|NCT01370616|147183819|SUPERIORITY_OR_OTHER||Estimated Difference|1.8|||||TWO_SIDED|95.0|-2.0|5.8|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||5.8|-2.0|
73817872|NCT01370616|147183820|SUPERIORITY_OR_OTHER||Estimated Difference|-1.8|||||TWO_SIDED|95.0|-5.7|1.9|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||1.9|-5.7|
73817873|NCT01578499|147183828|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|42.2|||<|0.001|TWO_SIDED|95.0|27.5|56.8||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel|||Based on a two-sided Χ² test with a significance level of 0.05, and a 10% dropout rate, a sample size of approximately 124 participants was calculated to provide 90% power to detect a 30% improvement in ORR4 in the brentuximab vedotin group.||56.8|27.5|<0.001
73817874|NCT01578499|147183829|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|15.6||||0.0002|TWO_SIDED|95.0|-2.5|33.0||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel|||||33.0|-2.5|0.0002
73817875|NCT01578499|147183830|OTHER||Hazard Ratio (HR)|0.378|||<|0.001|TWO_SIDED|95.0|0.247|0.577|||Log Rank||||Hazard ratio brentuximab vedotin/ comparator (methotrexate or bexarotene) with the 95% CI from a stratified Cox regression model with treatment as the explanatory variable and baseline disease diagnosis (MF or pcALCL) as stratification factor.|0.577|0.247|<0.001
73817876|NCT01578499|147183831|SUPERIORITY_OR_OTHER_LEGACY||Estimate of difference|-19.0|||<|0.001|TWO_SIDED|95.0|-26.7|-11.4|||ANCOVA|||P-value is calculated using the analysis of covariance (ANCOVA) model controlling for baseline symptom domain score, eastern cooperative oncology group (ECOG) performance status score (=0 and ≥1), and disease diagnosis (pcALCL and MF) between the brentuximab vedotin and comparator (methotrexate or bexarotene) arms.||-11.4|-26.7|<0.001
73817877|NCT02670382|147183843|SUPERIORITY||mean values, log transformed|||||0.33|||||||Mixed Models Analysis|||||||0.33
73817878|NCT02670382|147183843|SUPERIORITY||mean difference, log transformed values|||||0.92|||||||Mixed Models Analysis|||||||0.92
73817879|NCT02670382|147183843|SUPERIORITY||mean difference, log transformed values|||||0.44|||||||Mixed Models Analysis|||||||0.44
73817880|NCT02670382|147183844|SUPERIORITY||mean difference, log transformed values|||||0.34|||||||Mixed Models Analysis|||||||0.34
73817881|NCT02670382|147183844|SUPERIORITY||mean difference, log transformed values|||||0.5|||||||Mixed Models Analysis|||||||0.50
73817882|NCT02670382|147183844|SUPERIORITY||mean differences, log transformed values|||||0.83|||||||Mixed Models Analysis|||||||0.83
73817883|NCT02670382|147183845|EQUIVALENCE|primary hypothesis is that EPA will not differ from placebo|mean differences|||||0.1|||||||Mixed Models Analysis|||||||0.10
73817884|NCT02670382|147183845|SUPERIORITY||mean difference|||||0.005|||||||Mixed Models Analysis|||||||0.005
73817885|NCT02670382|147183845|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
73817886|NCT00822328|147183866|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).||||<0.05
73817887|NCT00822328|147183868|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).||||<0.05
73817888|NCT05811026|147183872|SUPERIORITY||Median Difference (Net)|5.0||||0.075|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.075
73817889|NCT05811026|147183873|SUPERIORITY||Median Difference (Net)|0.17||||0.4727|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.4727
73817890|NCT05811026|147183874|SUPERIORITY||Median Difference (Net)|-1.5||||0.7326|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.7326
73817891|NCT05811026|147183875|SUPERIORITY||Median Difference (Net)|0.61||||0.0757|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0757
73817892|NCT05811026|147183876|SUPERIORITY||Median Difference (Net)|37.75||||0.0376|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0376
73817893|NCT05811026|147183877|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.3123|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.3123
73817894|NCT05811026|147183878|SUPERIORITY||Median Difference (Final Values)|1.0||||0.1009|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.1009
73817895|NCT05811026|147183879|SUPERIORITY||Mean Difference (Net)|5.5||||0.0088|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0088
73817896|NCT05811026|147183880|SUPERIORITY||Median Difference (Net)|-0.03||||0.4274|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.4274
73817897|NCT05811026|147183881|SUPERIORITY||Mean Difference (Net)|1.75||||0.6497|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6497
73817898|NCT05811026|147183882|SUPERIORITY||Median Difference (Net)|0.54||||0.0006|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0006
73817899|NCT05811026|147183883|SUPERIORITY||Median Difference (Net)|34.5||||0.0002|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0002
73817900|NCT05811026|147183884|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6231|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6231
73817901|NCT05811026|147183885|SUPERIORITY||Median Difference (Final Values)|0.0||||0.3327|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.3327
73817902|NCT05811026|147183886|SUPERIORITY||Median Difference (Net)|7.25||||0.0752|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0752
73817903|NCT05811026|147183887|SUPERIORITY||Median Difference (Net)|-0.94||||0.0982|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0982
73817904|NCT05811026|147183888|SUPERIORITY||Median Difference (Net)|-0.5||||0.8541|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.8541
73817905|NCT05811026|147183889|SUPERIORITY||Median Difference (Net)|0.63||||0.0758|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0758
73817906|NCT05811026|147183890|SUPERIORITY||Median Difference (Net)|41.75||||0.066|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.066
73817907|NCT05811026|147183891|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.6961|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6961
73817908|NCT05811026|147183892|SUPERIORITY||Median Difference (Final Values)|1.0||||0.0067|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0067
73817909|NCT02223364|147183899|SUPERIORITY|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||||||0.144
73817910|NCT02223364|147183899|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
73817911|NCT02223364|147183899|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
73817912|NCT02223364|147183900|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73817913|NCT02223364|147183900|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73817914|NCT02223364|147183900|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
73817915|NCT02223364|147183901|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73817916|NCT02223364|147183901|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73817917|NCT02223364|147183901|SUPERIORITY|||||||0.257|||||||Wilcoxon (Mann-Whitney)|||||||0.257
73817918|NCT02223364|147183902|SUPERIORITY|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||||||0.059
73817919|NCT02223364|147183902|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73817920|NCT02223364|147183902|SUPERIORITY|||||||0.214|||||||Wilcoxon (Mann-Whitney)|||||||0.214
73817921|NCT02223364|147183903|SUPERIORITY|||||||0.189|||||||Wilcoxon (Mann-Whitney)|||||||0.189
73817922|NCT02223364|147183903|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.043
73817923|NCT02223364|147183903|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
73817924|NCT02223364|147183904|SUPERIORITY|||||||0.958|||||||Wilcoxon (Mann-Whitney)|||||||0.958
73817925|NCT02223364|147183904|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
73817926|NCT02223364|147183904|SUPERIORITY|||||||0.132|||||||Wilcoxon (Mann-Whitney)|||||||0.132
73817927|NCT02223364|147183905|SUPERIORITY|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||||||0.493
73817928|NCT02223364|147183905|SUPERIORITY|||||||0.299|||||||Wilcoxon (Mann-Whitney)|||||||0.299
73817929|NCT02223364|147183905|SUPERIORITY|||||||0.797|||||||Wilcoxon (Mann-Whitney)|||||||0.797
73817930|NCT02223364|147183906|SUPERIORITY|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||||||0.571
73817931|NCT02223364|147183906|SUPERIORITY|||||||0.991|||||||Wilcoxon (Mann-Whitney)|||||||0.991
73817932|NCT02223364|147183906|SUPERIORITY|||||||0.496|||||||Wilcoxon (Mann-Whitney)|||||||0.496
73817933|NCT02223364|147183907|SUPERIORITY|||||||0.807|||||||Wilcoxon (Mann-Whitney)|||||||0.807
73817934|NCT02223364|147183907|SUPERIORITY|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
73817935|NCT02223364|147183907|SUPERIORITY|||||||0.104|||||||Wilcoxon (Mann-Whitney)|||||||0.104
73817936|NCT02223364|147183909|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
73817937|NCT02223364|147183909|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73817938|NCT02223364|147183909|SUPERIORITY|||||||0.293|||||||Wilcoxon (Mann-Whitney)|||||||0.293
73817939|NCT02223364|147183910|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
73817940|NCT02223364|147183910|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
73817941|NCT02223364|147183910|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||||||0.148
73817942|NCT02223364|147183911|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
73817943|NCT02223364|147183911|SUPERIORITY|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
73817944|NCT02223364|147183911|SUPERIORITY|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
73817945|NCT02223364|147183912|SUPERIORITY|||||||0.768|||||||Kruskal-Wallis|||||||0.768
73817946|NCT02223364|147183913|SUPERIORITY|||||||0.623|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)||||0.623
73817947|NCT02223364|147183913|SUPERIORITY|||||||0.001|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)||||0.001
73817948|NCT02223364|147183913|SUPERIORITY|||||||0.048|||||||Regression, Cox|||Within group comparison of baseline and three months (approximately 12 weeks)||||0.048
73817949|NCT00762034|147183945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.94896|TWO_SIDED|95.0|0.86|1.16|||Log Rank|||||1.16|0.86|0.94896
73817950|NCT00762034|147183946|SUPERIORITY_OR_OTHER|||||||0.72997||95.0|||||Fisher Exact|||||||0.72997
73817951|NCT00762034|147183947|SUPERIORITY_OR_OTHER|||||||0.20892|||||||Fisher Exact|||||||0.20892
73817952|NCT00762034|147183948|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.01206|TWO_SIDED|95.0|0.71|0.96|||Log Rank|||||0.96|0.71|0.01206
73817953|NCT00762034|147183949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.006|TWO_SIDED|95.0|0.67|0.94|||Log Rank|||||0.94|0.67|0.006
73817954|NCT00762034|147183954|SUPERIORITY_OR_OTHER|||||||0.667||95.0||||Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.667
73817955|NCT00762034|147183955|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value for FACT-L Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.815
73817956|NCT00762034|147183955|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||p-value for FACT-L TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.978
73817957|NCT00762034|147183956|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for FACT/GOG-Ntx Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73817958|NCT00762034|147183956|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for FACT/GOG-Ntx TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
73817959|NCT00762034|147183970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.338|0.681||p-value was not adjusted for multiple comparisons.|Regression, Cox|||||0.681|0.338|<0.001
73817960|NCT00762034|147183971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.673|TWO_SIDED|95.0|0.654|1.316||p-value is for TS Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.316|0.654|0.673
73817961|NCT00762034|147183971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.521||||0.287|TWO_SIDED|95.0|0.157|1.729||p-value is for TS Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.729|0.157|0.287
73817962|NCT00762034|147183971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.759||||0.2|TWO_SIDED|95.0|0.498|1.157||p-value is for TS Nucleus Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.157|0.498|0.2
73817963|NCT00762034|147183971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.969||||0.915|TWO_SIDED|95.0|0.54|1.738||p-value is for TS Nucleus Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.738|0.540|0.915
73817964|NCT00762034|147183972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.891|TWO_SIDED|95.0|0.622|1.511||p-value for FR-α Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.511|0.622|0.891
73817965|NCT00762034|147183972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.592||||0.06|TWO_SIDED|95.0|0.342|1.023||p-value for FR-α Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.023|0.342|0.060
73817966|NCT00762034|147183972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.905|TWO_SIDED|95.0|0.49|1.88||p-value for FR-α Membrane Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.880|0.490|0.905
73817967|NCT00762034|147183972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.859||||0.455|TWO_SIDED|95.0|0.575|1.281||p-value for FR-α Membrane Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.281|0.575|0.455
73817968|NCT02442206|147183973|SUPERIORITY||Mean Difference (Net)|10.27|||<|0.0001|TWO_SIDED|95.0|6.209|14.331|||ANOVA|||||14.331|6.209|<0.0001
73817969|NCT02442206|147183974|SUPERIORITY||Mean Difference (Net)|0.42|||<|0.0001|TWO_SIDED|95.0|0.36|0.49|||ANOVA|||||0.49|0.36|<0.0001
73817970|NCT02442206|147183975|SUPERIORITY||Mean Difference (Net)|0.67|||<|0.0001|TWO_SIDED|95.0|0.55|0.8|||ANOVA|||||0.80|0.55|<0.0001
73817971|NCT02442206|147183976|SUPERIORITY||Mean Difference (Net)|0.446|||<|0.0001|TWO_SIDED|95.0|0.352|0.541|||ANOVA|||||0.541|0.352|<0.0001
73817972|NCT02442206|147183977|SUPERIORITY||Mean Difference (Net)|-0.177||||0.0017|TWO_SIDED|95.0|-0.285|-0.07|||ANOVA|||||-0.070|-0.285|0.0017
73817973|NCT02442206|147183978|SUPERIORITY||Mean Difference (Net)|-0.751|||<|0.0001|TWO_SIDED|95.0|-0.925|-0.577|||ANOVA|||||-0.577|-0.925|<0.0001
73817974|NCT02442206|147183979|SUPERIORITY||Mean Difference (Net)|-1.639|||<|0.0001|TWO_SIDED|95.0|-1.945|-1.332|||ANOVA|||||-1.332|-1.945|<0.0001
73817975|NCT02442206|147183980|SUPERIORITY||Mean Difference (Net)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.761|-0.489|||ANOVA|||||-0.489|-0.761|<0.0001
73817976|NCT02442206|147183981|SUPERIORITY||Mean Difference (Net)|1.209||||0.142|TWO_SIDED|95.0|-0.419|2.836|||ANOVA|||LV EF||2.836|-0.419|0.1420
73817977|NCT02442206|147183981|SUPERIORITY||Mean Difference (Net)|1.131||||0.1732|TWO_SIDED|95.0|-0.512|2.774|||ANOVA|||RV EF||2.774|-0.512|0.1732
73817978|NCT02442206|147183982|SUPERIORITY||Mean Difference (Net)|2.241||||0.0437|TWO_SIDED|95.0|0.066|4.417|||ANOVA|||LV ESV||4.417|0.066|0.0437
73817979|NCT02442206|147183982|SUPERIORITY||Mean Difference (Net)|2.095||||0.1236|TWO_SIDED|95.0|-0.591|4.782|||ANOVA|||RV ESV||4.782|-0.591|0.1236
73817980|NCT02442206|147183983|SUPERIORITY||Mean Difference (Net)|9.357||||0.0002|TWO_SIDED|95.0|4.649|14.065|||ANOVA|||||14.065|4.649|0.0002
73817981|NCT02442206|147183984|SUPERIORITY||Mean Difference (Net)|0.337||||0.0032|TWO_SIDED|95.0|0.118|0.555|||ANOVA|||LVCO||0.555|0.118|0.0032
73817982|NCT02442206|147183984|SUPERIORITY||Mean Difference (Net)|0.281||||0.0182|TWO_SIDED|95.0|0.05|0.512|||ANOVA|||RVCO||0.512|0.050|0.0182
73817983|NCT00497146|147183985|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Mixed Models Analysis|Mixed model includes treatment, visit, gender, baseline RAAS inhibitor use, country, baseline value, and treatment by visit interaction.||||||0.145
73817984|NCT01088711|147184012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.76|||||TWO_SIDED|90.0|82.7|99.37|||Difference in geometric means (GMs)|||||99.37|82.70|
73817985|NCT01088711|147184014|SUPERIORITY_OR_OTHER||Ratio of geometric least-squares means|1.92|||||TWO_SIDED|90.0|1.55|2.38|||||GMR is ratio of active GLP-1 levels in omarigliptin:placebo groups.|||2.38|1.55|
73817986|NCT01088711|147184015|SUPERIORITY_OR_OTHER||Ratio of geometric least-squares means|0.91|||||TWO_SIDED|90.0|0.72|1.17|||||GMR is ratio of total GLP-1 levels in omarigliptin:placebo groups.|||1.17|0.72|
73817987|NCT01240902|147184017|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|26.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED|95.0|22.3|30.1|||z-test, 1 sided||Kaplan-Meier Event Rate Greenwood Standard Error|TAVR with the Medtronic CoreValve System meets the Performance Goal in the 12 month rate of all-cause mortality or major stroke H0: = πMCS TAVI ≥ 43.0% HA: = πMCS TAVI \< 43.0% In the above expressions πMCS TAVI denotes the rate of all-cause mortality or major stroke during a fixed follow-up of 1 year.||30.1|22.3|<0.0001
73817988|NCT01240902|147184017|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|39.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED||||||||Kaplan-Meier Event Rate Greenwood Standard Error|No performance goal created, only descriptive statistics are provided.||||
73817989|NCT01240902|147184017|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 12 month all-cause mortality estimated rate was 20% for each group with a noninferiority margin of 7.5 percentage points. Assuming a 1:1 ratio in the treatment assignments, we estimated that a total of 355 patients were required in each group for the study to have power of 80% at a one-sided alpha level of 0.05. Accounting for a 10% loss to follow-up, we calculated that we would need to enroll 790 patients.|||||<|0.0001|TWO_SIDED||||||z-test, 1 sided|||||||<0.0001
73817990|NCT01240902|147184018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1033|TWO_SIDED|||||Hierarchical test item #5, MACCE at 30 days or hospital discharge; whichever was longer. K-M rates TAVR 8.21%, SAVR 10.93%, Difference -2.73%, Standard Error 2.16%, and Upper 95% CI 1.5%.|Kaplan-Meier Point Estimate|Using Greenwood formula||"Powered Secondary Hypothesis: TAVR with the Medtronic CoreValve System was superior to SAVR in binary rate of MACCE at 30 days or hospital discharge, whichever was longer:~H0: πMCS TAVR = πSAVR HA: πMCS TAVR \< πSAVR In the above expression πMCS TAVR and πSAVR denoted rates of MACCE at 30 days or hospital discharge, whichever was longer.~Assumptions:~1:1 treatment allocation ratio One-sided alpha=0.025 SAVR = 20.0% MCS TAVI = 12.1% Power = \>80%"||||0.1033
73817991|NCT01240902|147184022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6|STANDARD_DEVIATION|0.9|<|0.0001|TWO_SIDED|||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 2 sided|||Change in NYHA classification from baseline to 1 year from secondary objective #5. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.||||<0.0001
73896510|NCT00913458|147326250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55||||0.713|TWO_SIDED|95.0|-16.4|11.2|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||11.2|-16.4|0.7130
73817992|NCT01240902|147184022|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin= 0.375. For subjects with NYHA categories at both baseline and 1 year visit, the NYHA classification improvements were calculated as NYHAbaseline - NYHA1year.|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 1 sided|||"Change in NYHA classification from baseline to 1 year: TAVR vs. SAVR from secondary objective #5. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean number of classification improvements in NYHA from baseline to 1 year."||||<0.0001
73817993|NCT01240902|147184025|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #4|t-test, 2 sided|||Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year from secondary objective #8. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.||||<0.0001
73817994|NCT01240902|147184025|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 5||||||0.0063|TWO_SIDED|||||Hierarchical test item #4|t-test, 1 sided|||"Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year: TAVR vs. SAVR from secondary objective #8. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -5 HA: µ MCS TAVR \> µ SAVR -5 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the KCCQ score from baseline to 1 year."||||0.0063
73817995|NCT01240902|147184025|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #6. Item #5 failed, therefore, item #6 also fails. Nominal p- value provided.|t-test, 2 sided|||"Change in SF-12 Physical Summary Scale from baseline to 30 days: TAVR vs. SAVR from secondary objective #8. The two-sided two-sample t-test was used to test at a level 0.05 the hypotheses:~H0: µ MCS TAVR = µ SAVR HA: µ MCS TAVR ≠ µ SAVR In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the SF-12 Physical Summary Scale from baseline to 30 days."||||<0.0001
73817996|NCT01240902|147184026|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #2|t-test, 2 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."||||<0.0001
73817997|NCT01240902|147184026|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 0.375|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #2|t-test, 1 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in effective orifice area from Baseline to 1 year measured in cm2."||||<0.0001
73817998|NCT01240902|147184027|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #1|t-test, 2 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."||||<0.0001
73817999|NCT01240902|147184027|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 15|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #1|t-test, 1 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level of 0.05 the hypotheses: H0: μ MCS TAVR ≤ μ SAVR -15 HA: μ MCS TAVR \> μ SAVR -15 In the above expression μ MCS TAVR and μ SAVR denoted the mean improvements in mean gradient from Baseline to 1 year measured in mmHg."||||<0.0001
73818000|NCT01441245|147184037|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.04
73818001|NCT01441245|147184038|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|TWO_SIDED||||||Chi-squared|||Qualitative variables are expressed as percentage and compared with chi-square test. p values \<0.05 were considered significant.||||<0.01
73818002|NCT01441245|147184039|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
73818003|NCT01441245|147184040|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
73818004|NCT01441245|147184041|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
73818005|NCT01441245|147184041|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|Risk Ratio (RR)|2.06||||0.01|TWO_SIDED|95.0|1.65|2.57|||Regression, Linear||BNP levels at discharge \>500 pg/ml (RR: 2.06 \[1.65-2.57\];).|||2.57|1.65|0.01
73818006|NCT01441245|147184042|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.03|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.03
73818007|NCT01441245|147184043|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.01
73818008|NCT01441245|147184044|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant||||0.05
73818009|NCT01441245|147184045|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|TWO_SIDED||||||Chi-squared|||Qualitative variables are expressed as percentage of partecipants and compared with chi-square test. p-value equal or lower than 0.05 are considered statistically significant.||||<0.01
73818010|NCT03441685|147184060|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.73||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.73
73818011|NCT03441685|147184060|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.69||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.69
73818012|NCT03441685|147184060|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.79||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.79
73818013|NCT03441685|147184060|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.002||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.002
73818014|NCT03441685|147184060|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.049||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.049
73818015|NCT03441685|147184060|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.016||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.016
73818016|NCT03441685|147184061|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||0.76||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.76
73818017|NCT03441685|147184061|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||0.79||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.79
73818018|NCT03441685|147184061|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||1||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||1.00
73818019|NCT03441685|147184061|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.003||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.003
73818020|NCT03441685|147184061|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.029||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.029
73818021|NCT03441685|147184061|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.027||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.027
73818022|NCT03441685|147184062|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.72||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.72
73818023|NCT03441685|147184062|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.46||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.46
73818024|NCT03441685|147184062|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.89||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.89
73818025|NCT03441685|147184062|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
73818026|NCT03441685|147184062|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.018||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.018
73818027|NCT03441685|147184062|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.027||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.027
73818028|NCT03441685|147184063|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.64||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.64
73818029|NCT03441685|147184063|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.16||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.16
73818030|NCT03441685|147184063|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.18||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.18
73818031|NCT03441685|147184063|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
73818032|NCT03441685|147184063|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.034||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.034
73818033|NCT03441685|147184063|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.063||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.063
73818034|NCT03441685|147184064|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.35||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.35
73818035|NCT03441685|147184064|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.18||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.18
73818036|NCT03441685|147184064|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.58|||||||Wilcoxon Signed Ranks Test|||||||0.58
73818037|NCT03441685|147184064|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.006||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.006
73818038|NCT03441685|147184064|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.02||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.02
73818039|NCT03441685|147184064|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.18||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.18
73818040|NCT03441685|147184065|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.56||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.56
73818041|NCT03441685|147184065|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.1||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.10
73818042|NCT03441685|147184065|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.71||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.71
73818043|NCT03441685|147184065|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
73818044|NCT03441685|147184065|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.024||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.024
73818045|NCT03441685|147184065|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.1||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.10
73818046|NCT02095197|147184097|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||0.23
73818047|NCT02095197|147184098|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||||||0.47
73818048|NCT02095197|147184099|SUPERIORITY_OR_OTHER|||||||0.3|||||||Chi-squared|||||||0.30
73818049|NCT02095197|147184100|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||||||0.41
73818050|NCT01537835|147184101|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||p-value is adjusted for multiple comparisons|Kruskal-Wallis|||||||0.17
73818051|NCT03077607|147184107|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant % coefficient of variation (CV) of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|139.92|||||TWO_SIDED|90.0|113.26|172.87||||||Confidence interval (CI): 90 percent (%) CI on geometric least squares (LS) mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using analysis of variance (ANOVA)||172.87|113.26|
73818052|NCT03077607|147184108|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|150.71|||||TWO_SIDED|90.0|136.47|166.43||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||166.43|136.47|
73818053|NCT03077607|147184109|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|156.24|||||TWO_SIDED|90.0|137.58|177.42||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||177.42|137.58|
73818054|NCT03077607|147184110|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|136.62|||||TWO_SIDED|90.0|103.2|180.87||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||180.87|103.20|
73818055|NCT03077607|147184111|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|105.37|||||TWO_SIDED|90.0|98.04|113.24||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||113.24|98.04|
73818056|NCT03077607|147184112|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|102.04|||||TWO_SIDED|90.0|94.02|110.74||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||110.74|94.02|
73818057|NCT04333225|147184133|OTHER|Other: estimating risk reduction|Risk Ratio (RR)|2.0718||||0.0112|TWO_SIDED|95.0|1.15|3.72|||Chi-squared|||||3.72|1.15|0.0112
73818058|NCT04333225|147184134|OTHER|Other: Estimating hazard ratio|Hazard Ratio (HR)|0.35||||0.0105|TWO_SIDED|95.0|0.17|0.75|||Log Rank|||||0.75|0.17|0.0105
73818059|NCT04399538|147184165|SUPERIORITY||Difference in least square (LS) mean|-52.36|||<|0.0001||80.0|-60.07|-43.17|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-43.17|-60.07|<0.0001
73818060|NCT04399538|147184165|SUPERIORITY||Difference in LS mean|-56.58|||<|0.0001||80.0|-63.88|-47.8|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-47.80|-63.88|<0.0001
73818061|NCT04399538|147184165|SUPERIORITY||Difference in LS mean|-58.8|||<|0.0001||80.0|-65.66|-50.57|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. Relative change was converted to percent change as follows: Percent change = 100\*(RC-1). 80% CI was calculated based on difference in LS mean between groups.||-50.57|-65.66|<0.0001
73818062|NCT04399538|147184165|SUPERIORITY||Difference in LS mean|-45.8||||0.0003||80.0|-55.86|-33.46|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-33.46|-55.86|0.0003
73818063|NCT01215435|147184173|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean HbA1c treatment difference was below or equal to 0.4%. This is equivalent to using a one-sided test of size 2.5%.|Estimated treatment difference, Mean|-0.14|||<|0.001||95.0|-0.4|0.13|||Regression, Linear|||H0: D \> 0.4% against H1: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (pre-breakfast OD minus pre-dinner OD)||0.13|-0.40|<0.001
73818064|NCT01215435|147184174|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-3.14||||0.6215||95.0|-15.65|9.37|||Regression, Linear|||||9.37|-15.65|0.6215
73818065|NCT02870205|147184191|SUPERIORITY||||||<|0.001||||||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.|ANCOVA|||||||<0.001
73818066|NCT02870205|147184191|SUPERIORITY|||||||0.028|||||||ANCOVA|||||||0.028
73818067|NCT02870205|147184191|SUPERIORITY|||||||0.019|||||||ANCOVA|||||||0.019
73818068|NCT02870205|147184191|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
73818069|NCT02870205|147184191|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
73818070|NCT01420016|147184199|EQUIVALENCE|The analysis used a time-by-condition mixed model to estimate the annual rate of change in post-index CV risk values by treatment group. The models included fixed effects for study arm (CDS vs. UC), time (years since index), and study-arm-by-time comparing the rate of change in CDS versus UC and a random clinic intercept. The intervention effect was the difference in rate of change in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P\<0.05).|Slope Difference (Net)|-2.25|||<|0.05|TWO_SIDED|95.0|-3.45|-1.04||A priori power analysis (power=.80, α2=.05) estimated detectable group difference in CVR at 1 year of \~2-3%, assuming 18 clinics, 1000 patients per clinic (actual 400), 3 CVR per patient (actual 2.3), and ICC=.01-03 (actual .019). p-value calculated.|Mixed Models Analysis||The intervention effect was the difference in annualized rates of change (slope) in CV risk in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P\<0.05).|||-1.04|-3.45|<0.05
73818071|NCT02179749|147184221|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.2||0.51|TWO_SIDED||||||ANOVA|||||||0.51
73818072|NCT02179749|147184221|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.038|TWO_SIDED||||||Mixed Models Analysis|||Latent growth model includes one week on study drug and two weeks after the last dose of study drug. Principal predictors were drug plasma concentration and baseline treatment goal of abstinence or non abstinence. Arms were combined for this analysis.||||0.038
73818073|NCT02179749|147184222|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|36.7||0.5|TWO_SIDED||||||ANOVA|411 and 102 degrees of freedom||||||0.50
73818074|NCT02756364|147184223|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.537|TWO_SIDED|95.0|0.47|1.26|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original interactive response technology (IRT) stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.26|0.47|0.537
73818075|NCT02756364|147184223|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.849|TWO_SIDED|95.0|0.53|1.45|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.45|0.53|0.849
73818076|NCT02756364|147184224|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.276|TWO_SIDED|95.0|0.36|1.4|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.40|0.36|0.276
73818077|NCT02756364|147184224|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.47|TWO_SIDED|95.0|0.47|1.68|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.68|0.47|0.470
73818078|NCT02756364|147184225|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.495|TWO_SIDED|95.0|0.46|1.25|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.25|0.46|0.495
73818079|NCT02756364|147184225|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.646|TWO_SIDED|95.0|0.49|1.38|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.38|0.49|0.646
73818080|NCT02756364|147184226|SUPERIORITY||Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.68|7.29|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||7.29|0.68|
73818081|NCT02756364|147184226|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.34|4.39|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||4.39|0.34|
73818082|NCT02756364|147184227|SUPERIORITY||Odds Ratio (OR)|2.56|||||TWO_SIDED|95.0|0.94|6.94|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||6.94|0.94|
73818083|NCT02756364|147184227|SUPERIORITY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|0.69|4.44|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||4.44|0.69|
73818084|NCT03597139|147184301|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.1491|TWO_SIDED|95.0|-1.7|10.9|||ANCOVA|||||10.9|-1.7|0.1491
73818085|NCT03597139|147184302|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.1187|TWO_SIDED|95.0|-1.6|13.9|||ANCOVA|||||13.9|-1.6|0.1187
73818086|NCT03597139|147184303|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.2128|TWO_SIDED|95.0|-3.7|16.5|||ANCOVA|||||16.5|-3.7|0.2128
73818087|NCT03597139|147184304|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.8408|TWO_SIDED|95.0|-11.8|9.6|||ANCOVA|||||9.6|-11.8|0.8408
73818088|NCT03597139|147184305|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.5356|TWO_SIDED|95.0|-6.1|11.6|||ANCOVA|||||11.6|-6.1|0.5356
73818089|NCT03597139|147184306|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.1787|TWO_SIDED|95.0|-2.7|14.1|||ANCOVA|||||14.1|-2.7|0.1787
73818090|NCT03597139|147184307|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.7666|TWO_SIDED|95.0|-12.6|9.3|||ANCOVA|||||9.3|-12.6|0.7666
73818091|NCT03597139|147184308|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.8082|TWO_SIDED|95.0|-10.7|8.4|||ANCOVA|||||8.4|-10.7|0.8082
73818092|NCT03597139|147184309|SUPERIORITY||Mean Difference (Final Values)|11.6||||0.6362|TWO_SIDED|95.0|-37.0|60.3|||ANCOVA|||||60.3|-37|0.6362
73818093|NCT03597139|147184310|SUPERIORITY||Mean Difference (Final Values)|9.6||||0.0961|TWO_SIDED|95.0|-1.7|20.9||Frequency|ANCOVA|||Frequency||20.9|-1.7|0.0961
73818094|NCT03597139|147184310|SUPERIORITY||Mean Difference (Final Values)|7.7||||0.1722|TWO_SIDED|95.0|-3.4|18.7|||ANCOVA|||Severity||18.7|-3.4|0.1722
73818095|NCT03597139|147184311|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.0051|TWO_SIDED|95.0|1.6|8.9||Left Eye|ANCOVA|||Left Eye||8.9|1.6|0.0051
73818096|NCT03597139|147184311|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.0104|TWO_SIDED|95.0|1.1|8.4||Right Eye|ANCOVA|||Right Eye||8.4|1.1|0.0104
73818097|NCT03597139|147184312|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.0003|TWO_SIDED|95.0|-3.2|-1.0||Left Eye|ANCOVA||Add in RE LE info|Left Eye||-1.0|-3.2|0.0003
73818098|NCT03597139|147184312|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.0038|TWO_SIDED|95.0|-2.6|-0.5||Right Eye|ANCOVA|||Right Eye||-0.5|-2.6|0.0038
73818099|NCT01249833|147184328|SUPERIORITY_OR_OTHER||LS Means Difference|-30.4||||0.0492|TWO_SIDED|95.0|-60.7|-0.1|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||-0.1|-60.7|.0492
73818100|NCT01249833|147184329|SUPERIORITY_OR_OTHER||LS Means Difference|3.8||||0.0054|TWO_SIDED|95.0|1.14|6.42|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||6.42|1.14|0.0054
73818101|NCT01249833|147184330|SUPERIORITY_OR_OTHER||LS Means Difference|3.9||||0.9685|TWO_SIDED|95.0|-190.1|197.9|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||197.9|-190.1|.9685
73818102|NCT01249833|147184331|SUPERIORITY_OR_OTHER||LS Means Difference|1.9||||0.3195|TWO_SIDED|95.0|-1.9|5.7|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|Alertness: the higher the value, the greater the alertness.||5.7|-1.9|.3195
73818103|NCT01249833|147184331|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6||||0.7219|TWO_SIDED|95.0|-4.1|2.9|||ANCOVA||The LS means for Standard of Care AL one was subtracted from that of Oseltamivir.|Calmness: the higher the value, the greater the calmness.||2.9|-4.1|.7219
73818104|NCT01249833|147184331|SUPERIORITY_OR_OTHER||LS Means Difference|3.3||||0.1162|TWO_SIDED|95.0|-0.8|7.4|||ANCOVA||The LS means of Standard of Care Alone was subtracted from that of Oseltamivir.|Contentedness: the higher the value, the greater the contentedness.||7.4|-.8|.1162
73818105|NCT03796676|147184332|SUPERIORITY||Estimate of difference|16.7||||0.0147|TWO_SIDED|95.0|3.5|29.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||29.9|3.5|0.0147
73818106|NCT03796676|147184332|SUPERIORITY||Estimate of difference|20.6||||0.003|TWO_SIDED|95.0|7.3|33.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||33.9|7.3|0.0030
73818107|NCT03796676|147184333|SUPERIORITY||Estimate of difference|26.5||||0.0002|TWO_SIDED|95.0|13.1|39.8|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||39.8|13.1|0.0002
73818108|NCT03796676|147184333|SUPERIORITY||Estimate of difference|29.4|||<|0.0001|TWO_SIDED|95.0|16.3|42.5|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||42.5|16.3|<0.0001
73818109|NCT03796676|147184334|SUPERIORITY||Estimate of difference|14.7||||0.0119||95.0|3.5|25.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 100 mg minus placebo|||25.9|3.5|0.0119
73818110|NCT03796676|147184334|SUPERIORITY||Estimate of difference|26.1|||<|0.0001|TWO_SIDED|95.0|13.9|38.3|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 200 mg minus placebo|||38.3|13.9|<0.0001
73818111|NCT03796676|147184334|SUPERIORITY||Estimate of difference|10.9||||0.0971|TWO_SIDED|95.0|-1.8|23.6|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 100 mg minus placebo|||23.6|-1.8|0.0971
73818112|NCT03796676|147184334|SUPERIORITY||Estimate of difference|29.4|||<|0.0001|TWO_SIDED|95.0|16.0|42.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 200 mg minus placebo|||42.9|16.0|<0.0001
73818113|NCT03796676|147184334|SUPERIORITY||Estimate of difference|22.8||||0.0035|TWO_SIDED|95.0|8.0|37.7|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||37.7|8.0|0.0035
73818114|NCT03796676|147184334|SUPERIORITY||Estimate of difference|25.6||||0.0013|TWO_SIDED|95.0|10.6|40.6|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||40.6|10.6|0.0013
73818115|NCT03796676|147184335|SUPERIORITY||Mean Difference (Net)|-0.5||||0.0664|TWO_SIDED|95.0|-1.1|0.0|||Mixed Models Analysis||The least squares mean difference at Week 12 was calculated by PF-04965842 100 mg minus placebo|||0.0|-1.1|0.0664
73818116|NCT03796676|147184335|SUPERIORITY||Mean Difference (Net)|-0.7||||0.0142|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis||The least squares mean difference at Week 12 was calculated by PF-04965842 200 mg minus placebo|||-0.1|-1.3|0.0142
73818117|NCT02724410|147184377|OTHER|Chi Square test of independence||||||0.7188|||||||Chi-squared|||||||0.7188
73818118|NCT02724410|147184378|OTHER|Chi Square test of independence||||||0.5933|||||||Chi-squared|||||||.5933
73818119|NCT02724410|147184379|OTHER|Chi Square test of independence|||||>|0.99|||||||Chi-squared|||||||>.99
73818120|NCT02724410|147184380|OTHER|T-test for difference between groups|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<.0001
73818121|NCT01649362|147184426|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||||||0.63
73818122|NCT01649362|147184427|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
73818123|NCT01649362|147184428|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
73818124|NCT00929994|147184435|OTHER||||||=|0.06||||||A Bonferroni correction for multiple testing was used for post hoc contrasts. Assumption of sphericity was met for all analyses determined by the Mauchley test of sphericity (all \>.05).|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance of 6MWD, was utilized between the 3 test times 0, 3, and 6 months). A Bonferroni correction for multiple testing was used for post hoc contrasts.||||=0.06
73818125|NCT00929994|147184435|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
73818126|NCT00929994|147184436|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
73818127|NCT00929994|147184437|SUPERIORITY|||||||0.04||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts.|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of CES-D was utilized between the 3 test times baseline, 3 and 6 months.||||0.04
73818128|NCT00929994|147184438|SUPERIORITY||||||>|0.05||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of MoCA was utilized between the 3 test times (-3, 0 and 6 months). A Bonferroni correction for multiple testing was used for post-hoc contrasts.||||>0.05
73818129|NCT01964989|147184445|SUPERIORITY|Relative vaccine efficacy (rVE; ≥6 to \<72 months) rVE = (1-HR) is the relative vaccine efficacy of aQIV and HR is defined as hazard ratio between aQIV and non adjuvanted comparator.|Cox Proportional Hazard|-0.67|||||TWO_SIDED|95.0|-19.81|15.41||||||||15.41|-19.81|
73818130|NCT01964989|147184452|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% confidence interval (CI) on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|1.91|||||TWO_SIDED|95.0|1.8|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.8|
73818131|NCT01964989|147184452|OTHER||GMT ratio|1.86|||||TWO_SIDED|95.0|1.7|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.7|
73818132|NCT01964989|147184452|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|1.71|||||TWO_SIDED|95.0|1.6|1.8||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||1.8|1.6|
73818133|NCT01964989|147184452|OTHER||GMT ratio|1.57|||||TWO_SIDED|95.0|1.4|1.7||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||1.7|1.4|
73818134|NCT01964989|147184452|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|2.19|||||TWO_SIDED|95.0|2.0|2.4||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.4|2.0|
73818135|NCT01964989|147184452|OTHER||GMT ratio|1.86|||||TWO_SIDED|95.0|1.7|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.7|
73818136|NCT01964989|147184452|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|2.27|||||TWO_SIDED|95.0|2.0|2.6||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.6|2.0|
73818137|NCT01964989|147184452|OTHER||GMT ratio|1.8|||||TWO_SIDED|95.0|1.6|2.1||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.1|1.6|
73818138|NCT01964989|147184454|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.8|1.0||||||aQIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).||1.0|0.8|
73818139|NCT01964989|147184454|OTHER||GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.1||||||aQIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.9|
73818140|NCT01964989|147184454|OTHER||GMT ratio|0.98|||||TWO_SIDED|95.0|0.8|1.1||||||aQIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
73818141|NCT01964989|147184454|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.8|1.1||||||aQIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
73818142|NCT01964989|147184454|OTHER||GMT ratio|0.95|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
73818143|NCT01964989|147184454|OTHER||GMT ratio|0.98|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
73818144|NCT01964989|147184454|OTHER||GMT ratio|0.95|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
73818145|NCT01964989|147184454|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.7|1.2||||||TIV/QIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).||1.2|0.7|
73818146|NCT01964989|147184456|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|8.2|||||TWO_SIDED|95.0|5.0|11.3||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.||11.3|5.0|
73818147|NCT01964989|147184456|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|5.2|||||TWO_SIDED|95.0|1.9|8.4||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.||8.4|1.9|
73818148|NCT01964989|147184456|SUPERIORITY||Seroconversion difference|21.3|||||TWO_SIDED|95.0|18.1|24.5||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/YAM.||24.5|18.1|
73818149|NCT01964989|147184456|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|13.6|||||TWO_SIDED|95.0|10.0|17.3||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/VIC.||17.3|10.0|
73818150|NCT01964989|147184457|OTHER||Mean Difference (Final Values)|11.5|||||TWO_SIDED|95.0|9.4|13.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.||13.7|9.4|
73818151|NCT01964989|147184457|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|6.1|9.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.||9.7|6.1|
73818152|NCT01964989|147184457|OTHER||Mean Difference (Final Values)|21.9|||||TWO_SIDED|95.0|18.1|25.6||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/YAM.||25.6|18.1|
73818153|NCT01964989|147184457|OTHER||Mean Difference (Final Values)|20.9|||||TWO_SIDED|95.0|15.9|25.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/VIC.||25.7|15.9|
73818154|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|5.9|9.7||||||Difference in HI titers ≥ 1:110 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.7|5.9|
73818155|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|7.8|11.9||||||Difference in HI Titers ≥ 1:151 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||11.9|7.8|
73818156|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|16.1|||||TWO_SIDED|95.0|13.5|18.7||||||Difference in HI Titers ≥ 1:215 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||18.7|13.5|
73818157|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|19.8|26.4||||||Difference in HI Titers ≥ 1:330 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||26.4|19.8|
73818158|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|24.1|||||TWO_SIDED|95.0|20.6|27.6||||||Difference in HI Titers ≥ 1:629 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||27.6|20.6|
73818159|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|4.5|7.5||||||Difference in HI Titers ≥ 1:110 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||7.5|4.5|
73818160|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|6.1|9.6||||||Difference in HI Titers ≥ 1:151 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.6|6.1|
73818161|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|11.7|||||TWO_SIDED|95.0|9.6|13.9||||||Difference in HI Titers ≥ 1:215 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||13.9|9.6|
73818162|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|19.0|||||TWO_SIDED|95.0|16.1|22.0||||||Difference in HI Titers ≥ 1:330 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||22.0|16.1|
73818163|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|21.1|||||TWO_SIDED|95.0|17.8|24.3||||||Difference in HI Titers ≥ 1:629 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||24.3|17.8|
73818164|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|28.8|||||TWO_SIDED|95.0|25.1|32.3||||||Difference in HI Titers ≥ 1:110 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||32.3|25.1|
73818165|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|26.3|||||TWO_SIDED|95.0|22.6|29.9||||||Difference in HI Titers ≥ 1:151 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||29.9|22.6|
73818166|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|21.8|||||TWO_SIDED|95.0|18.3|25.3||||||Difference in HI Titers ≥ 1:215 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||25.3|18.3|
73818167|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|8.6|14.5||||||Difference in HI Titers ≥ 1:330 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||14.5|8.6|
73818168|NCT01964989|147184458|OTHER||Mean Difference (Final Values)|6.8|||||TWO_SIDED|95.0|4.3|9.4||||||Difference in HI Titers ≥ 1:629 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.4|4.3|
73818169|NCT00424593|147184468|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Model included treatment, non-steriodal anti-inflammatory drug (NSAID) use (Yes/No), investigator, visit, treatment-by-visit interaction, baseline pain severity, and baseline-by-visit interaction.|Repeated Measures Analysis|||||||0.004
73818170|NCT00424593|147184469|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||ANCOVA|||||||0.014
73818171|NCT00424593|147184470|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value is for 13 Week Change from Baseline.|ANCOVA|||||||0.009
73818172|NCT00424593|147184471|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Average Pain Score Change from Baseline.|ANCOVA|||||||0.002
73818173|NCT00424593|147184471|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for Worst Pain Score Change from Baseline.|ANCOVA|||||||0.014
73818174|NCT00424593|147184471|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Night Pain Score Change from Baseline.|ANCOVA|||||||0.007
73818175|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Worst Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.011
73818176|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Least Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.001
73818177|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Average Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.019
73818178|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pain Right Now Score Week 13 Change from Baseline.|ANCOVA|||||||0.002
73818179|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for General Activity Week 13 Change from Baseline.|ANCOVA|||||||0.068
73818180|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Mood Week 13 Change from Baseline.|ANCOVA|||||||0.009
73818181|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Walking Ability Week 13 Change from Baseline.|ANCOVA|||||||0.006
73818182|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for Normal Work Week 13 Change from Baseline.|ANCOVA|||||||0.024
73818183|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Relations With People Week 13 Change from Baseline.|ANCOVA|||||||0.005
73818184|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Sleep Week 13 Change from Baseline.|ANCOVA|||||||0.051
73818185|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Enjoyment of Life Week 13 Change from Baseline.|ANCOVA|||||||0.013
73818186|NCT00424593|147184472|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Average Interference Week 13 Change from Baseline.|ANCOVA|||||||0.005
73818187|NCT00424593|147184473|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.092
73818188|NCT00424593|147184474|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||||||0.060
73818189|NCT00424593|147184475|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||Fisher Exact|||||||0.087
73818190|NCT00424593|147184476|SUPERIORITY_OR_OTHER|||||||0.329||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.329
73818191|NCT00424593|147184477|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Mental Component Summary Change from Baseline.|ANCOVA|||||||0.051
73818192|NCT00424593|147184477|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||P-value for Physical Component Summary Change from Baseline.|ANCOVA|||||||0.220
73818193|NCT00424593|147184477|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Bodily Pain Change from Baseline.|ANCOVA|||||||0.038
73818194|NCT00424593|147184477|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value for General Health Change from Baseline.|ANCOVA|||||||0.041
73818195|NCT00424593|147184477|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for Mental Health Change from Baseline.|ANCOVA|||||||0.093
73818196|NCT00424593|147184477|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||P-value for Physical Functioning Change from Baseline.|ANCOVA|||||||0.210
73818197|NCT00424593|147184477|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||P-value for Role-Emotional Change from Baseline.|ANCOVA|||||||0.170
73818198|NCT00424593|147184477|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value for Role-Physical Change from Baseline.|ANCOVA|||||||0.306
73818199|NCT00424593|147184477|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for Social Functioning Change from Baseline.|ANCOVA|||||||0.053
73818200|NCT00424593|147184477|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value for Vitality Change from Baseline.|ANCOVA|||||||0.040
73818201|NCT00424593|147184478|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.117
73818202|NCT00424593|147184479|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||P-value for Absenteeism Week 13 Change from Baseline.|ANCOVA|||||||0.063
73818203|NCT00424593|147184479|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||P-value for Presenteeism Week 13 Change from Baseline.|ANCOVA|||||||0.452
73818204|NCT00424593|147184479|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Work Productivity Loss Week 13 Change from Baseline.|ANCOVA|||||||0.736
73818205|NCT00424593|147184479|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Work Activity Impairment Week 13 Change from Baseline.|ANCOVA|||||||0.002
73818206|NCT00424593|147184480|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.177
73818207|NCT00424593|147184481|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for Anxiety Subscale Change from Baseline.|ANCOVA|||||||0.122
73818208|NCT00424593|147184481|SUPERIORITY_OR_OTHER|||||||0.262||95.0||||P-value for Depression Subscale Change from Baseline.|ANCOVA|||||||0.262
73818209|NCT00424593|147184482|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.||||||0.046
73818210|NCT00424593|147184483|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.||||||0.008
73818211|NCT00424593|147184484|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-value for Week 13 Change from Baseline.|ANOVA|||||||0.028
73818212|NCT00424593|147184485|SUPERIORITY_OR_OTHER|||||||0.764||95.0||||P-value for SBP Week 13 Change from Baseline.|ANOVA|||||||0.764
73818213|NCT00424593|147184485|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for DBP Week 13 Change from Baseline.|ANOVA|||||||0.093
73818214|NCT00424593|147184486|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Week 13 Change from Baseline.|ANOVA|||||||0.008
73896511|NCT00913458|147326250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.6628|TWO_SIDED|95.0|-16.6|10.6|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||10.6|-16.6|0.6628
73896512|NCT00913458|147326252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.74||||0.1303|TWO_SIDED|95.0|-15.5|2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.0|-15.5|0.1303
73818215|NCT01796301|147184489|SUPERIORITY|A two-step, step-down, fixed-sequential testing procedure was used to test the primary and key secondary efficacy endpoints for the comparison of romosozumab to teriparatide in the order presented for multiplicity adjustment to maintain the overall significance level at 0.05. The Key Secondary Efficacy Endpoints are the first 8 secondary endpoints reported below.|Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.7|3.8|||Linear mixed effects repeated measures|||The primary analysis to assess the treatment difference (Romosozumab - Teriparatide) employed a linear mixed effects model for repeated measures. The model included main effects for treatment group, visit (categorical), baseline sCTX, baseline hip DXA BMD value, machine type (categorical), and machine type-by-baseline value interaction (to adjust for the effect of machine type on baseline DXA BMD value) as fixed main effects using an unstructured within-subject variance-covariance structure.||3.8|2.7|< 0.0001
73818216|NCT01796301|147184490|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.5|3.7|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||3.7|2.5|< 0.0001
73818217|NCT01796301|147184491|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.0|2.8|< 0.0001
73818218|NCT01796301|147184492|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.0|2.8|< 0.0001
73818219|NCT01796301|147184493|SUPERIORITY||Treatment difference|4.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|3.9|5.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||5.3|3.9|< 0.0001
73818220|NCT01796301|147184494|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.5|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.6|2.5|< 0.0001
73818221|NCT01796301|147184495|SUPERIORITY||Treatment difference|3.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.2|2.9|< 0.0001
73818222|NCT01796301|147184496|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.4|3.8|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.8|2.4|< 0.0001
73818223|NCT01796301|147184497|SUPERIORITY||Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|2.1|4.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.3|2.1|< 0.0001
73818224|NCT01796301|147184498|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.6|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.6|2.6|< 0.0001
73818225|NCT01796301|147184499|SUPERIORITY||Treatment difference|3.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.2|2.9|< 0.0001
73818226|NCT01796301|147184500|SUPERIORITY||Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.5|3.9|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||3.9|2.5|< 0.0001
73818227|NCT01796301|147184501|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.6|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.2|2.6|< 0.0001
73818228|NCT01796301|147184502|SUPERIORITY||Treatment difference|3.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.9|4.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.6|2.9|< 0.0001
73818229|NCT01796301|147184503|SUPERIORITY||Treatment difference|4.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|3.4|5.4|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||5.4|3.4|< 0.0001
73818230|NCT02187029|147184514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-52.55|||||TWO_SIDED|90.0|-56.32|-48.78|||Bayesian ANCOVA|||||-48.780|-56.320|
73818231|NCT02187029|147184514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.31|||||TWO_SIDED|90.0|-71.31|-61.54|||Bayesian ANCOVA|||||-61.540|-71.310|
73818232|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||||90.0|-0.55|-0.06|||Mixed Models Analysis|||Day 1, Hour 1||-0.06|-0.55|
73818233|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.95|-0.28|||Mixed Models Analysis|||Day 1, Hour 2||-0.28|-0.95|
73818234|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-1.52|-1.16|||Mixed Models Analysis|||Day 1, Hour 4||-1.16|-1.52|
73818235|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.86|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-2.38|-1.33|||Mixed Models Analysis|||Day 1, Hour 8||-1.33|-2.38|
73818236|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-2.18|-1.48|||Mixed Models Analysis|||Day 1, Hour 12||-1.48|-2.18|
73818237|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-2.11|-1.37|||Mixed Models Analysis|||Day 1, Hour 24||-1.37|-2.11|
73818238|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-2.89|-2.06|||Mixed Models Analysis|||Day 3||-2.06|-2.89|
73818239|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-3.29|-2.2|||Mixed Models Analysis|||Day 7, pre-dose||-2.20|-3.29|
73818240|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-3.39|-2.21|||Mixed Models Analysis|||Day 7, Hour 1||-2.21|-3.39|
73818241|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.06|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-3.72|-2.41|||Mixed Models Analysis|||Day 7, Hour 2||-2.41|-3.72|
73818242|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-4.03|-2.77|||Mixed Models Analysis|||Day7, Hour 4||-2.77|-4.03|
73818243|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-3.82|-2.79|||Mixed Models Analysis|||Day 7, Hour 8||-2.79|-3.82|
73818244|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-3.72|-2.68|||Mixed Models Analysis|||Day 7, Hour 12||-2.68|-3.72|
73818245|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.81|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-3.3|-2.32|||Mixed Models Analysis|||Day 7, Hour 24||-2.32|-3.30|
73818246|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.56|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-5.19|-3.92|||Mixed Models Analysis|||Day 11||-3.92|-5.19|
73818247|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.32|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-4.75|-3.88|||Mixed Models Analysis|||Day 14, pre-dose||-3.88|-4.75|
73818248|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.55|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-5.02|-4.08|||Mixed Models Analysis|||Day 14, Hour 1||-4.08|-5.02|
73818249|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.97|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-5.47|-4.47|||Mixed Models Analysis|||Day 14, Hour 2||-4.47|-5.47|
73818250|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.43|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-5.83|-5.02|||Mixed Models Analysis|||Day 14, Hour 4||-5.02|-5.83|
73818251|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.57|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-6.08|-5.05|||Mixed Models Analysis|||Day 14, Hour 8||-5.05|-6.08|
73818252|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.34|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-5.86|-4.82|||Mixed Models Analysis|||Day 14, Hour 12||-4.82|-5.86|
73818253|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.65|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-5.12|-4.18|||Mixed Models Analysis|||Day 14, Hour 24||-4.18|-5.12|
73818254|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-2.97|0.79|||Mixed Models Analysis|||Follow-up, Day 25-29||0.79|-2.97|
73818255|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.92|-0.32|||Mixed Models Analysis|||Day 1, Hour 1||-0.32|-0.92|
73818256|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-1.61|-0.75|||Mixed Models Analysis|||Day 1, Hour 2||-0.75|-1.61|
73818257|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.91|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-3.14|-2.69|||Mixed Models Analysis|||Day 1, Hour 4||-2.69|-3.14|
73818258|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-4.36|-3.03|||Mixed Models Analysis|||Day 1, Hour 8||-3.03|-4.36|
73818259|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-4.28|-3.4|||Mixed Models Analysis|||Day 1, Hour 12||-3.40|-4.28|
73818260|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.47|STANDARD_ERROR_OF_MEAN|0.26||||90.0|-3.94|-3.0|||Mixed Models Analysis|||Day 1, Hour 24||-3.00|-3.94|
73818261|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.76|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-5.29|-4.23|||Mixed Models Analysis|||Day 3||-4.23|-5.29|
73818262|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-6.62|-5.0|||Mixed Models Analysis|||Day 7, pre-dose||-5.00|-6.62|
73818263|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.84|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|90.0|-6.72|-4.95|||Mixed Models Analysis|||Day 7, Hour 1||-4.95|-6.72|
73818264|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-7.17|-5.19|||Mixed Models Analysis|||Day 7, Hour 2||-5.19|-7.17|
73818265|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.51|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-7.46|-5.55|||Mixed Models Analysis|||Day 7, Hour 4||-5.55|-7.46|
73818266|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.29|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-7.07|-5.51|||Mixed Models Analysis|||Day 7, Hour 8||-5.51|-7.07|
73818267|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.24|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-7.03|-5.44|||Mixed Models Analysis|||Day 7, Hour 12||-5.44|-7.03|
73818268|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.75|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-6.5|-4.99|||Mixed Models Analysis|||Day 7, Hour 24||-4.99|-6.50|
73818269|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.62|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-6.59|-4.65|||Mixed Models Analysis|||Day 11||-4.65|-6.59|
73818270|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.76|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-6.42|-5.1|||Mixed Models Analysis|||Day 14, pre-dose||-5.10|-6.42|
73818271|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.96|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|90.0|-6.67|-5.24|||Mixed Models Analysis|||Day 14, Hour 1||-5.24|-6.67|
73818272|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.14|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|-6.9|-5.38|||Mixed Models Analysis|||Day 14, Hour 2||-5.38|-6.90|
73818273|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-7.03|-5.81|||Mixed Models Analysis|||Day 14, Hour 4||-5.81|-7.03|
73818274|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.64|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-7.41|-5.87|||Mixed Models Analysis|||Day 14, Hour 8||-5.87|-7.41|
73818275|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-7.18|-5.63|||Mixed Models Analysis|||Day 14, Hour 12||-5.63|-7.18|
73818276|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.77|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-6.47|-5.07|||Mixed Models Analysis|||Day 14, Hour 24||-5.07|-6.47|
73818277|NCT02187029|147184519|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.66|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|90.0|-4.96|-0.35|||Mixed Models Analysis|||Follow-up, Day 25-29||-0.35|-4.96|
73818278|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0355|STANDARD_ERROR_OF_MEAN|0.0423|||TWO_SIDED|90.0|-0.1103|0.0394|||Mixed Models Analysis|||Day 1, Hour 1||0.0394|-0.1103|
73818279|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0152|STANDARD_ERROR_OF_MEAN|0.0631|||TWO_SIDED|90.0|-0.1269|0.0966|||Mixed Models Analysis|||Day 1, Hour 2||0.0966|-0.1269|
73818280|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0331|STANDARD_ERROR_OF_MEAN|0.0422|||TWO_SIDED|90.0|-0.1078|0.0417|||Mixed Models Analysis|||Day 1, Hour 4||0.0417|-0.1078|
73818281|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0035|STANDARD_ERROR_OF_MEAN|0.0443|||TWO_SIDED|90.0|-0.075|0.082|||Mixed Models Analysis|||Day 1, Hour 8||0.0820|-0.0750|
73818282|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0502|STANDARD_ERROR_OF_MEAN|0.0367|||TWO_SIDED|90.0|-0.1153|0.0149|||Mixed Models Analysis|||Day 1, Hour 12||0.0149|-0.1153|
73818283|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.0553|||TWO_SIDED|90.0|-0.1058|0.0899|||Mixed Models Analysis|||Day 1, Hour 24||0.0899|-0.1058|
73818284|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0539|STANDARD_ERROR_OF_MEAN|0.0561|||TWO_SIDED|90.0|-0.1538|0.046|||Mixed Models Analysis|||Day 7, pre-dose||0.0460|-0.1538|
73818285|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0109|STANDARD_ERROR_OF_MEAN|0.0506|||TWO_SIDED|90.0|-0.0793|0.101|||Mixed Models Analysis|||Day 7, Hour 1||0.1010|-0.0793|
73818286|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.033|STANDARD_ERROR_OF_MEAN|0.0496|||TWO_SIDED|90.0|-0.0554|0.1213|||Mixed Models Analysis|||Day 7, Hour 2||0.1213|-0.0554|
73818287|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0086|STANDARD_ERROR_OF_MEAN|0.0459|||TWO_SIDED|90.0|-0.0733|0.0905|||Mixed Models Analysis|||Day 7, Hour 4||0.0905|-0.0733|
73818288|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0244|STANDARD_ERROR_OF_MEAN|0.0349|||TWO_SIDED|90.0|-0.0865|0.0378|||Mixed Models Analysis|||Day 7, Hour 8||0.0378|-0.0865|
73818289|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0526|STANDARD_ERROR_OF_MEAN|0.0251|||TWO_SIDED|90.0|-0.0973|-0.0079|||Mixed Models Analysis|||Day 7, Hour 12||-0.0079|-0.0973|
73818290|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0298|STANDARD_ERROR_OF_MEAN|0.0331|||TWO_SIDED|90.0|-0.0889|0.0292|||Mixed Models Analysis|||Day 7, Hour 24||0.0292|-0.0889|
73818291|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0167|STANDARD_ERROR_OF_MEAN|0.0268|||TWO_SIDED|90.0|-0.0649|0.0315|||Mixed Models Analysis|||Day 14, pre-dose||0.0315|-0.0649|
73818292|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0616|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|90.0|0.001|0.1222|||Mixed Models Analysis|||Day 14, Hour 1||0.1222|0.0010|
73818293|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1025|STANDARD_ERROR_OF_MEAN|0.0512|||TWO_SIDED|90.0|0.0104|0.1945|||Mixed Models Analysis|||Day 14, Hour 2||0.1945|0.0104|
73818294|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0062|STANDARD_ERROR_OF_MEAN|0.0495|||TWO_SIDED|90.0|-0.0827|0.0952|||Mixed Models Analysis|||Day 14, Hour 4||0.0952|-0.0827|
73818295|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0124|STANDARD_ERROR_OF_MEAN|0.0443|||TWO_SIDED|90.0|-0.0672|0.0919|||Mixed Models Analysis|||Day 14, Hour 8||0.0919|-0.0672|
73818296|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0186|STANDARD_ERROR_OF_MEAN|0.0408|||TWO_SIDED|90.0|-0.0918|0.0547|||Mixed Models Analysis|||Day 14, Hour 12||0.0547|-0.0918|
73818297|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0413|STANDARD_ERROR_OF_MEAN|0.0433|||TWO_SIDED|90.0|-0.1192|0.0365|||Mixed Models Analysis|||Day 14, Hour 24||0.0365|-0.1192|
73818298|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4011|STANDARD_ERROR_OF_MEAN|0.3916|||TWO_SIDED|90.0|-0.2968|1.099|||Mixed Models Analysis|||Follow-up, Day 25-29||1.0990|-0.2968|
73818299|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1175|STANDARD_ERROR_OF_MEAN|0.0537|||TWO_SIDED|90.0|0.0223|0.2127|||Mixed Models Analysis|||Day 1, Hour 1||0.2127|0.0223|
73818300|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3845|STANDARD_ERROR_OF_MEAN|0.0802|||TWO_SIDED|90.0|0.2424|0.5266|||Mixed Models Analysis|||Day 1, Hour 2||0.5266|0.2424|
73818301|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3812|STANDARD_ERROR_OF_MEAN|0.0536|||TWO_SIDED|90.0|0.2862|0.4762|||Mixed Models Analysis|||Day 1, Hour 4||0.4762|0.2862|
73818302|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2841|STANDARD_ERROR_OF_MEAN|0.0563|||TWO_SIDED|90.0|0.1843|0.3838|||Mixed Models Analysis|||Day 1, Hour 8||0.3838|0.1843|
73818303|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1462|STANDARD_ERROR_OF_MEAN|0.0467|||TWO_SIDED|90.0|0.0635|0.2289|||Mixed Models Analysis|||Day 1, Hour 12||0.2289|0.0635|
73818304|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.168|STANDARD_ERROR_OF_MEAN|0.0702|||TWO_SIDED|90.0|0.0436|0.2924|||Mixed Models Analysis|||Day 1, Hour 24||0.2924|0.0436|
73818305|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1303|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|90.0|-0.0172|0.2778|||Mixed Models Analysis|||Day 7, pre-dose||0.2778|-0.0172|
73818306|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1953|STANDARD_ERROR_OF_MEAN|0.0747||||90.0|0.0625|0.3281|||Mixed Models Analysis|||Day 7, Hour 1||0.3281|0.0625|
73818307|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5409|STANDARD_ERROR_OF_MEAN|0.0729|||TWO_SIDED|90.0|0.411|0.6707|||Mixed Models Analysis|||Day 7, Hour 2||0.6707|0.4110|
73818308|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5235|STANDARD_ERROR_OF_MEAN|0.0675|||TWO_SIDED|90.0|0.4032|0.6438|||Mixed Models Analysis|||Day 7, Hour 4||0.6438|0.4032|
73818309|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3857|STANDARD_ERROR_OF_MEAN|0.0512|||TWO_SIDED|90.0|0.2944|0.4769|||Mixed Models Analysis|||Day 7, Hour 8||0.4769|0.2944|
73818310|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0216|STANDARD_ERROR_OF_MEAN|0.0368|||TWO_SIDED|90.0|-0.0439|0.0872|||Mixed Models Analysis|||Day 7, Hour 12||0.0872|-0.0439|
73818311|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1708|STANDARD_ERROR_OF_MEAN|0.0486|||TWO_SIDED|90.0|0.0841|0.2574|||Mixed Models Analysis|||Day 7, Hour 24||0.2574|0.0841|
73818312|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.166|STANDARD_ERROR_OF_MEAN|0.0377|||TWO_SIDED|90.0|0.0982|0.2338|||Mixed Models Analysis|||Day 14, pre-dose||0.2338|0.0982|
73818313|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3524|STANDARD_ERROR_OF_MEAN|0.0477|||TWO_SIDED|90.0|0.2667|0.438|||Mixed Models Analysis|||Day 14, Hour 1||0.4380|0.2667|
73818314|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5631|STANDARD_ERROR_OF_MEAN|0.0724|||TWO_SIDED|90.0|0.433|0.6932|||Mixed Models Analysis|||Day 14, Hour 2||0.6932|0.4330|
73818315|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5807|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|0.4549|0.7065|||Mixed Models Analysis|||Day 14, Hour 4||0.7065|0.4549|
73818316|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2814|STANDARD_ERROR_OF_MEAN|0.0627|||TWO_SIDED|90.0|0.1688|0.394|||Mixed Models Analysis|||Day 14, Hour 8||0.3940|0.1688|
73818317|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1982|STANDARD_ERROR_OF_MEAN|0.0577|||TWO_SIDED|90.0|0.0945|0.3019|||Mixed Models Analysis|||Day 14, Hour 12||0.3019|0.0945|
73818318|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1465|STANDARD_ERROR_OF_MEAN|0.0615|||TWO_SIDED|90.0|0.0361|0.2569|||Mixed Models Analysis|||Day 14, Hour 24||0.2569|0.0361|
73818319|NCT02187029|147184525|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8565|STANDARD_ERROR_OF_MEAN|0.4796|||TWO_SIDED|90.0|0.0017|1.7112|||Mixed Models Analysis|||Follow-up, Day 25-29||1.7112|0.0017|
73818320|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.348|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.707|0.01|||Mixed Models Analysis|||Day 1, Hour 1||0.010|-0.707|
73818321|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.179|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|90.0|-0.533|0.175|||Mixed Models Analysis|||Day 1, Hour 2||0.175|-0.533|
73818322|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.258|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.568|0.052|||Mixed Models Analysis|||Day 1, Hour 4||0.052|-0.568|
73818323|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.046|STANDARD_ERROR_OF_MEAN|0.201||||90.0|-0.39|0.298|||Mixed Models Analysis|||Day 1, Hour 8||0.298|-0.390|
73818324|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.284|STANDARD_ERROR_OF_MEAN|0.168||||90.0|-0.575|0.006|||Mixed Models Analysis|||Day 1, Hour 12||0.006|-0.575|
73818325|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.166|STANDARD_ERROR_OF_MEAN|0.235|||TWO_SIDED|90.0|-0.569|0.237|||Mixed Models Analysis|||Day 1, Hour 24||0.237|-0.569|
73818326|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.263|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.657|0.132|||Mixed Models Analysis|||Day 7, pre-dose||0.132|-0.657|
73818327|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|90.0|-0.46|0.299|||Mixed Models Analysis|||Day 7, Hour 1||0.299|-0.460|
73818328|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.082|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.392|0.228|||Mixed Models Analysis|||Day 7, Hour 2||0.228|-0.392|
73818329|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.083|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|90.0|-0.408|0.242|||Mixed Models Analysis|||Day 7, Hour 4||0.242|-0.408|
73818330|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.207|STANDARD_ERROR_OF_MEAN|0.174|||TWO_SIDED|90.0|-0.508|0.095|||Mixed Models Analysis|||Day 7, Hour 8||0.095|-0.508|
73818331|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|-0.451|0.191|||Mixed Models Analysis|||Day 7, Hour 12||0.191|-0.451|
73818332|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.125|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|-0.445|0.196|||Mixed Models Analysis|||Day 7, Hour 24||0.196|-0.445|
73818333|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.188|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|90.0|-0.472|0.097|||Mixed Models Analysis|||Day 14, pre-dose||0.097|-0.472|
73818334|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.152|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.434|0.13|||Mixed Models Analysis|||Day 14, Hour 1||0.130|-0.434|
73818335|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.231|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|90.0|-0.504|0.043|||Mixed Models Analysis|||Day 14, Hour 2||0.043|-0.504|
73818336|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.405|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|90.0|-0.722|-0.088|||Mixed Models Analysis|||Day 14, Hour 4||-0.088|-0.722|
73818337|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.249|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.56|0.062|||Mixed Models Analysis|||Day 14, Hour 8||0.062|-0.560|
73818338|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.163|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.467|0.141|||Mixed Models Analysis|||Day 14, Hour 12||0.141|-0.467|
73818339|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.317|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.633|-0.002|||Mixed Models Analysis|||Day 14, Hour 24||-0.002|-0.633|
73818340|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.094|STANDARD_ERROR_OF_MEAN|0.339|||TWO_SIDED|90.0|-0.683|0.496|||Mixed Models Analysis|||Follow-up, Day 25-29||0.496|-0.683|
73818341|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.406|0.505|||Mixed Models Analysis|||Day 1, Hour 1||0.505|-0.406|
73818342|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.257|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.193|0.707|||Mixed Models Analysis|||Day 1, Hour 2||0.707|-0.193|
73818343|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.091|STANDARD_ERROR_OF_MEAN|0.229|||TWO_SIDED|90.0|-0.302|0.485|||Mixed Models Analysis|||Day 1, Hour 4||0.485|-0.302|
73818344|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|-0.107|0.768|||Mixed Models Analysis|||Day 1, Hour 8||0.768|-0.107|
73818345|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.283|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|90.0|-0.087|0.653|||Mixed Models Analysis|||Day 1, Hour 12||0.653|-0.087|
73818346|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.299|||TWO_SIDED|90.0|-0.024|1.0|||Mixed Models Analysis|||Day 1, Hour 24||1.000|-0.024|
73818347|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.206|STANDARD_ERROR_OF_MEAN|0.327|||TWO_SIDED|90.0|-0.356|0.768|||Mixed Models Analysis|||Day 7, pre-dose||0.768|-0.356|
73818348|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.123|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.41|0.656|||Mixed Models Analysis|||Day 7, Hour 1||0.656|-0.410|
73818349|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.396|STANDARD_ERROR_OF_MEAN|0.246|||TWO_SIDED|90.0|-0.025|0.818|||Mixed Models Analysis|||Day 7, Hour 2||0.818|-0.025|
73818350|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.077|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.523|0.368|||Mixed Models Analysis|||Day 7, Hour 4||0.368|-0.523|
73818351|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.254|STANDARD_ERROR_OF_MEAN|0.237|||TWO_SIDED|90.0|-0.154|0.661|||Mixed Models Analysis|||Day 7, Hour 8||0.661|-0.154|
73818352|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.125|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|-0.564|0.315|||Mixed Models Analysis|||Day 7, Hour 12||0.315|-0.564|
73818353|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.458|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|0.019|0.897|||Mixed Models Analysis|||Day 7, Hour 24||0.897|0.019|
73818354|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.418|STANDARD_ERROR_OF_MEAN|0.215|||TWO_SIDED|90.0|0.043|0.792|||Mixed Models Analysis|||Day 14, pre-dose||0.792|0.043|
73818355|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.521|STANDARD_ERROR_OF_MEAN|0.213|||TWO_SIDED|90.0|0.15|0.893|||Mixed Models Analysis|||Day 14, Hour 1||0.893|0.150|
73818356|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.204|||TWO_SIDED|90.0|0.172|0.888|||Mixed Models Analysis|||Day 14, Hour 2||0.888|0.172|
73818357|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.357|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|90.0|-0.069|0.782|||Mixed Models Analysis|||Day 14, Hour 4||0.782|-0.069|
73818358|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.242|||TWO_SIDED|90.0|-0.328|0.503|||Mixed Models Analysis|||Day 14, Hour 8||0.503|-0.328|
73818359|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.406|STANDARD_ERROR_OF_MEAN|0.236|||TWO_SIDED|90.0|0.0|0.812|||Mixed Models Analysis|||Day 14, Hour 12||0.812|0.000|
73818360|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|0.377|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|90.0|-0.047|0.802|||Mixed Models Analysis|||Day 14, Hour 24||0.802|-0.047|
73818361|NCT02187029|147184526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.223|STANDARD_ERROR_OF_MEAN|0.418|||TWO_SIDED|90.0|-0.949|0.502|||Mixed Models Analysis|||Follow-up, Day 25-29||0.502|-0.949|
73818362|NCT02187029|147184527|SUPERIORITY_OR_OTHER||LS Mean Difference|316.89|STANDARD_ERROR_OF_MEAN|166.57|||TWO_SIDED|90.0|21.91|611.88|||Mixed Models Analysis|||Day 1||611.88|21.91|
73818363|NCT02187029|147184527|SUPERIORITY_OR_OTHER||LS Mean Difference|61.97|STANDARD_ERROR_OF_MEAN|88.27|||TWO_SIDED|90.0|-94.87|218.82|||Mixed Models Analysis|||Day 7||218.82|-94.87|
73818364|NCT02187029|147184527|SUPERIORITY_OR_OTHER||LS Mean Difference|107.96|STANDARD_ERROR_OF_MEAN|100.38|||TWO_SIDED|90.0|-71.2|287.11|||Mixed Models Analysis|||Day 14||287.11|-71.20|
73818365|NCT02187029|147184527|SUPERIORITY_OR_OTHER||LS Mean Difference|433.21|STANDARD_ERROR_OF_MEAN|211.71|||TWO_SIDED|90.0|58.3|808.13|||Mixed Models Analysis|||Day 1||808.13|58.30|
73818366|NCT02187029|147184527|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2|STANDARD_ERROR_OF_MEAN|125.47|||TWO_SIDED|90.0|-208.07|234.47|||Mixed Models Analysis|||Day 7||234.47|-208.07|
73818367|NCT02187029|147184527|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.83|STANDARD_ERROR_OF_MEAN|142.95|||TWO_SIDED|90.0|-285.26|225.6|||Mixed Models Analysis|||Day 14||225.60|-285.26|
73818368|NCT02187029|147184528|SUPERIORITY_OR_OTHER||LS Mean Difference|3.44|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|90.0|0.71|6.17|||Mixed Models Analysis|||Day 1||6.17|0.71|
73818369|NCT02187029|147184528|SUPERIORITY_OR_OTHER||LS Mean Difference|3.67|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|1.97|5.37|||Mixed Models Analysis|||Day 7||5.37|1.97|
73818370|NCT02187029|147184528|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|6.24|9.96|||Mixed Models Analysis|||Day 14||9.96|6.24|
73818371|NCT02187029|147184528|SUPERIORITY_OR_OTHER||LS Mean Difference|13.12|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|90.0|9.65|16.59|||Mixed Models Analysis|||Day 1||16.59|9.65|
73818372|NCT02187029|147184528|SUPERIORITY_OR_OTHER||LS Mean Difference|27.99|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|25.49|30.49|||Mixed Models Analysis|||Day 7||30.49|25.49|
73818373|NCT02187029|147184528|SUPERIORITY_OR_OTHER||LS Mean Difference|28.77|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|26.14|31.41|||Mixed Models Analysis|||Day 14||31.41|26.14|
73818374|NCT02187029|147184529|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-1.31|3.1|||Mixed Models Analysis|||Day 1||3.10|-1.31|
73818375|NCT02187029|147184529|SUPERIORITY_OR_OTHER||LS Mean Difference|2.91|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|0.71|5.11|||Mixed Models Analysis|||Day 7||5.11|0.71|
73818376|NCT02187029|147184529|SUPERIORITY_OR_OTHER||LS Mean Difference|3.59|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|1.33|5.85|||Mixed Models Analysis|||Day 14||5.85|1.33|
73818377|NCT02187029|147184529|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-1.29|4.31|||Mixed Models Analysis|||Day 1||4.31|-1.29|
73818378|NCT02187029|147184529|SUPERIORITY_OR_OTHER||LS Mean Difference|7.73|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|4.57|10.89|||Mixed Models Analysis|||Day 7||10.89|4.57|
73818379|NCT02187029|147184529|SUPERIORITY_OR_OTHER||LS Mean Difference|9.07|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|5.91|12.23|||Mixed Models Analysis|||Day 14||12.23|5.91|
73818380|NCT02756819|147184553|OTHER||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test|||||||<0.001
73818381|NCT02756819|147184554|OTHER||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test|||||||<0.001
73818382|NCT02756819|147184557|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test|||||||<0.001
73818383|NCT02756819|147184557|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test|||||||<0.001
73818384|NCT02756819|147184557|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test|||||||<0.001
73818385|NCT02756819|147184557|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test|||||||<0.001
73818386|NCT02756819|147184557|OTHER||||||<|0.001|||||||Wilcoxon test|P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)||||||<0.001
73818387|NCT02756819|147184557|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test|||||||<0.001
73818388|NCT02756819|147184557|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test|||||||<0.001
73818389|NCT02756819|147184557|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test|||||||<0.001
73818390|NCT02756819|147184557|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test|||||||<0.001
73818391|NCT02756819|147184557|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test|||||||<0.001
73818392|NCT02756819|147184558|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test|||||||<0.001
73818393|NCT02756819|147184558|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test|||||||<0.001
73818394|NCT02756819|147184558|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test|||||||<0.001
73818395|NCT02756819|147184558|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test|||||||<0.001
73818396|NCT02756819|147184558|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)|Wilcoxon test|||||||<0.001
73818397|NCT02756819|147184558|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test|||||||<0.001
73818398|NCT02756819|147184558|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test|||||||<0.001
73818399|NCT02756819|147184558|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test|||||||<0.001
73818400|NCT02756819|147184558|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test|||||||<0.001
73818401|NCT02756819|147184558|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test|||||||<0.001
73818402|NCT01301079|147184572|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||Mann-Whitney|||||||0.113
73818403|NCT01301079|147184573|SUPERIORITY_OR_OTHER|||||||0.946|TWO_SIDED||||||t-test, 2 sided|||||||0.946
73818404|NCT01301079|147184574|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||t-test, 2 sided|||||||0.999
73818405|NCT01301079|147184575|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||t-test, 2 sided|||||||0.019
73818406|NCT01301079|147184576|SUPERIORITY_OR_OTHER|||||||0.652|TWO_SIDED||||||t-test, 2 sided|||||||0.652
73818407|NCT01301079|147184577|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED||||||t-test, 2 sided|||||||0.221
73818408|NCT01301079|147184578|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||t-test, 2 sided|||||||0.325
73818409|NCT01301079|147184579|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED||||||t-test, 2 sided|||||||0.386
73818410|NCT01301079|147184580|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED||||||t-test, 1 sided|||||||0.499
73818411|NCT01301079|147184581|SUPERIORITY_OR_OTHER|||||||0.909|TWO_SIDED||||||t-test, 2 sided|||||||0.909
73818412|NCT01301079|147184582|SUPERIORITY_OR_OTHER|||||||0.737|TWO_SIDED||||||t-test, 2 sided|||||||0.737
73818413|NCT01301079|147184583|SUPERIORITY_OR_OTHER||||||<|0.872|TWO_SIDED||||||t-test, 2 sided|||||||<0.872
73818414|NCT01301079|147184584|SUPERIORITY_OR_OTHER|||||||0.598|TWO_SIDED||||||t-test, 2 sided|||||||0.598
73818415|NCT01301079|147184585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.485|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.485
73818416|NCT01301079|147184586|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||t-test, 2 sided|||||||0.744
73818417|NCT01301079|147184587|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||t-test, 2 sided|||||||0.540
73818418|NCT01301079|147184588|SUPERIORITY_OR_OTHER|||||||0.673|TWO_SIDED||||||t-test, 2 sided|||||||0.673
73818419|NCT01301079|147184589|SUPERIORITY_OR_OTHER|||||||0.586|TWO_SIDED||||||t-test, 2 sided|||||||0.586
73818420|NCT01301079|147184590|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||t-test, 2 sided|||||||0.077
73818421|NCT01301079|147184591|SUPERIORITY_OR_OTHER|||||||0.677|TWO_SIDED||||||t-test, 2 sided|||||||0.677
73818422|NCT01301079|147184592|SUPERIORITY_OR_OTHER|||||||0.545|TWO_SIDED||||||t-test, 2 sided|||||||0.545
73818423|NCT01301079|147184593|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||t-test, 2 sided|||||||0.650
73818424|NCT01301079|147184594|SUPERIORITY_OR_OTHER|||||||0.593|TWO_SIDED||||||t-test, 2 sided|||||||0.593
73818425|NCT01301079|147184595|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
73818426|NCT01301079|147184596|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
73818427|NCT01301079|147184597|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
73818428|NCT01301079|147184598|SUPERIORITY_OR_OTHER|||||||0.611|TWO_SIDED||||||Chi-squared|||||||0.611
73818429|NCT01301079|147184599|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||t-test, 2 sided|||||||0.312
73818430|NCT01301079|147184600|SUPERIORITY_OR_OTHER|||||||0.676|TWO_SIDED||||||t-test, 2 sided|||||||0.676
73818431|NCT01301079|147184601|SUPERIORITY_OR_OTHER|||||||0.938|TWO_SIDED||||||t-test, 2 sided|||||||0.938
73818432|NCT01301079|147184602|SUPERIORITY_OR_OTHER|||||||0.385|TWO_SIDED||||||t-test, 2 sided|||||||0.385
73818433|NCT01301079|147184603|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED||||||t-test, 2 sided|||||||0.422
73818434|NCT01301079|147184604|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.500
73818435|NCT01301079|147184605|SUPERIORITY_OR_OTHER|||||||0.435|TWO_SIDED||||||t-test, 2 sided|||||||0.435
73818436|NCT01301079|147184606|SUPERIORITY_OR_OTHER|||||||0.745|TWO_SIDED||||||t-test, 2 sided|||||||0.745
73818437|NCT01301079|147184607|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||t-test, 2 sided|||||||0.557
73818438|NCT02700425|147184608|OTHER||||||<|0.001||||||P-value was not adjusted for multiple comparisons. Test was two-tailed, considered statistically significant with a p-value \<0.05, and conducted using SAS version 9.4 (SAS Institute Inc, Cary, NC) and STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon signed rank test||The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.||||<0.001
73818439|NCT02700425|147184608|OTHER||||||<|0.001||||||P-value was not adjusted for multiple comparisons. Test was two-tailed, considered statistically significant with a p-value \<0.05, and conducted using SAS version 9.4 (SAS Institute Inc, Cary, NC) and STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon signed rank test||The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.||||<0.001
73818440|NCT02700425|147184609|OTHER|paired t-test||||||0.002||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.002
73818441|NCT02700425|147184609|OTHER|paired t-test||||||0.002|||||||t-test, 2 sided|||Primary outcome of His Bundle Pacing was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.002
73818442|NCT02700425|147184610|OTHER|Log rank test of a survival analysis||||||0.62||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first cardiovascular hospitalization or death by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.62
73818443|NCT02700425|147184611|OTHER|||||||0.09||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon sign rank test||NYHA functional class of Coronary Sinus Pacing arm was presented at baseline as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon sign rank test.||||0.09
73818444|NCT02700425|147184611|OTHER|||||||0.32||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon sign rank test||NYHA functional class of the His Bundle Pacing arm was presented at baseline and 12 months as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon sign rank test.||||0.32
73818445|NCT02700425|147184612|OTHER|||||||0.35||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with His Bundle Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.35
73818446|NCT02700425|147184612|OTHER|||||||0.07||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with Coronary Sinus Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.07
73818447|NCT02700425|147184613|OTHER|Log rank test of a survival analysis||||||0.14||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first cardiovascular rehospitalization by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.14
73818448|NCT02700425|147184614|OTHER|Log rank test of a survival analysis||||||0.14||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first treated VT/VF by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.14
73818449|NCT00264290|147184622|OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
73818450|NCT04472494|147184636|SUPERIORITY||Odds Ratio (OR)|1.07||||0.9297|TWO_SIDED|95.0|0.26|4.49|||Cochran-Mantel-Haenszel Chi-Square test|||||4.49|0.26|0.9297
73818451|NCT04472494|147184637|SUPERIORITY||Adjusted mean difference from Placebo|0.64||||0.74|TWO_SIDED|95.0|-0.55|1.82|||Cochran-Mantel-Haenszel|||||1.82|-0.55|0.7400
73818452|NCT04472494|147184638|SUPERIORITY||Estimate of Difference|-0.1||||0.9684|TWO_SIDED|95.0|-20.55|20.34|||Cochran-Mantel-Haenszel Chi-Square test||Estimate of Difference is based on minimum risk weights|||20.34|-20.55|0.9684
73818453|NCT04472494|147184639|SUPERIORITY||Odds Ratio (OR)|0.85||||0.8504|TWO_SIDED|95.0|0.18|3.97|||Cochran-Mantel-Haenszel|||||3.97|0.18|0.8504
73818454|NCT04472494|147184640|SUPERIORITY||Odds Ratio (OR)|2.29||||0.2724|TWO_SIDED|95.0|0.53|9.82|||Cochran-Mantel-Haenszel|||||9.82|0.53|0.2724
73818455|NCT04472494|147184640|SUPERIORITY||Estimate of difference|12.78|||||TWO_SIDED|95.0|-10.61|36.17|||||||Estimate of difference is based on minimum risk weights|36.17|-10.61|
73818456|NCT04472494|147184641|SUPERIORITY||Odds Ratio (OR)|2.03||||0.4734|TWO_SIDED|95.0|0.33|12.64|||Cochran-Mantel-Haenszel|||||12.64|0.33|0.4734
73818457|NCT04472494|147184641|SUPERIORITY||Estimate of difference|5.43|||||TWO_SIDED|95.0|-16.71|27.57|||||Estimate of difference is based on minimum risk weights|||27.57|-16.71|
73818458|NCT00571103|147184645|SUPERIORITY_OR_OTHER||Mean Slope|-0.985|STANDARD_ERROR_OF_MEAN|0.158||0.05|TWO_SIDED|95.0|-1.0|1.0|||Linear mixed effects|||||1|-1|0.05
73818459|NCT02131233|147184664|NON_INFERIORITY_OR_EQUIVALENCE|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|0.51|||||TWO_SIDED|95.0|-4.204|5.223|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA \<=100,000 copies/mL or HIV-1 RNA \>100,000 copies/mL)||5.223|-4.204|
73818460|NCT02131233|147184665|NON_INFERIORITY_OR_EQUIVALENCE|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|1.449|||||TWO_SIDED|95.0|-4.41|7.308|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA \<=100,000 copies/mL or HIV-1 RNA \>100,000 copies/mL)||7.308|-4.410|
73818461|NCT02131233|147184666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-30.9|26.7|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.||26.7|-30.9|
73818462|NCT02131233|147184667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-32.8|31.6|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.||31.6|-32.8|
73818463|NCT02087943|147184718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-15.01||||0.1308|TWO_SIDED|95.0|-34.52|4.5||Based on an analysis of covariance model with the percentage change from baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, \> 20) as factors.|ANCOVA|||||4.50|-34.52|0.1308
73818464|NCT02087943|147184718|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.6||||0.0347|TWO_SIDED|95.0|-39.7|-1.5||Based on an analysis of covariance model with the percentage change from Baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, \> 20) as factors.|ANCOVA|||||-1.50|-39.70|0.0347
73818465|NCT02087943|147184719|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|-2.7||||0.4938|TWO_SIDED|95.0|-10.2|4.8||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with, Cochran-Mantel-Haenszel (CMH) weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.|||4.8|-10.2|0.4938
73818466|NCT02087943|147184719|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|8.0||||0.1368|TWO_SIDED|95.0|-2.3|18.2||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with, CMH weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.|||18.2|-2.3|0.1368
73818467|NCT02087943|147184720|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|-1.5||||0.8589|TWO_SIDED|95.0|-18.0|14.9|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with the CMH weights.|||14.9|-18.0|0.8589
73818468|NCT02087943|147184720|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|9.9||||0.2476|TWO_SIDED|95.0|-6.7|26.6|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with the CMH weights.|||26.6|-6.7|0.2476
73818469|NCT02087943|147184721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.17||||0.5286|TWO_SIDED|95.0|-21.34|10.99|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, \> 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.|||10.99|-21.34|0.5286
73818470|NCT02087943|147184721|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.17||||0.6092|TWO_SIDED|95.0|-20.22|11.88|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, \> 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.|||11.88|-20.22|0.6092
73818471|NCT01690299|147184726|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|27.5|||<|0.0001|TWO_SIDED|95.0|14.9|40.1||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||40.1|14.9|< 0.0001
73818472|NCT01690299|147184727|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|35.9|||<|0.0001|TWO_SIDED|95.0|23.3|48.5||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||48.5|23.3|<0.0001
73818473|NCT01690299|147184728|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.0||||0.0005|TWO_SIDED|95.0|8.4|27.7||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The p-value is from a CMH test stratified by the BMI at screening.|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.|||27.7|8.4|0.0005
73818474|NCT01690299|147184728|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|25.2|||<|0.0001|TWO_SIDED|95.0|14.8|35.5||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.||||35.5|14.8|<0.0001
73818475|NCT01690299|147184729|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-31.4|||<|0.0001|TWO_SIDED|95.0|-43.33|-19.46|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-19.46|-43.33|<0.0001
73818476|NCT01690299|147184729|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-39.85|||<|0.0001|TWO_SIDED|95.0|-51.78|-27.92|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-27.92|-51.78|<0.0001
73818477|NCT01690299|147184730|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|29.4||||0.0002|TWO_SIDED|95.0|14.9|43.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||43.9|14.9|0.0002
73818478|NCT01690299|147184730|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|49.8|||<|0.0001|TWO_SIDED|95.0|36.9|62.7||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||62.7|36.9|<0.0001
73818479|NCT01690299|147184731|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-4.48|||<|0.0001|TWO_SIDED|95.0|-6.82|-2.14|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-2.14|-6.82|<0.0001
73818480|NCT01690299|147184731|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-3.94||||0.0004|TWO_SIDED|95.0|-6.27|-1.6|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-1.60|-6.27|0.0004
73818481|NCT01690299|147184732|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|0.93||||0.7112|TWO_SIDED|95.0|-2.05|3.9|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||3.90|-2.05|0.7112
73818482|NCT01690299|147184732|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|2.22||||0.1719|TWO_SIDED|95.0|-0.75|5.19|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||5.19|-0.75|0.1719
73818483|NCT01690299|147184733|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.1||||0.0011|TWO_SIDED|95.0|7.6|28.6||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||28.6|7.6|0.0011
73818484|NCT01690299|147184733|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.7||||0.0021|TWO_SIDED|95.0|6.5|26.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||26.9|6.5|0.0021
73818485|NCT03836209|147184738|SUPERIORITY||Proportion Difference|-0.071||||0.366|TWO_SIDED|90.0|-0.205|0.062||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.062|-0.205|0.366
73818486|NCT03836209|147184739|SUPERIORITY||Proportion Difference|-0.059||||0.446|TWO_SIDED|90.0|-0.191|0.073||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.073|-0.191|0.446
73818487|NCT03836209|147184740|SUPERIORITY||Proportion Difference|0.047||||0.539|TWO_SIDED|90.0|-0.084|0.178||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.178|-0.084|0.539
73818488|NCT03836209|147184741|SUPERIORITY||Proportion Difference|0.131||||0.042|TWO_SIDED|90.0|0.02|0.242||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.242|0.020|0.042
73818489|NCT01753115|147184746|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margin is 0.80 - 1.25.|Ratio of AUC|0.887|||||TWO_SIDED|90.0|0.831|0.948||||||Analysis of Ciprofloxacin Area Under the Curve at Day 5 and Day 44.||0.948|0.831|
73818490|NCT01753115|147184746|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margin is 0.80 - 1.25.|Ratio of Cmax|0.944|||||TWO_SIDED|90.0|0.852|1.046||||||Analysis of Cmax at Day 5 and Day 44||1.046|0.852|
73818491|NCT01753115|147184747|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.67.|Ratio of GMT|1.267|||||TWO_SIDED|95.0|0.898|1.787||||||||1.787|0.898|
73818492|NCT01424241|147184755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|300.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||None available.||||<0.05
73818493|NCT01424241|147184755|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<.05
73818494|NCT00519584|147184762|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.39|||Log Rank||Ropivacaine/dex vs. Ropivacaine/saline|||0.39|0.08|<0.001
73818495|NCT00519584|147184762|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.23|0.83|||Log Rank||bupivacaine/dex vs. bupivacaine/Saline|||0.83|0.23|<0.001
73818496|NCT00519584|147184763|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
73818497|NCT00519584|147184763|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
73818498|NCT00519584|147184764|SUPERIORITY||||||<|0.001||||||adjusted significance level is 0.025|Wilcoxon (Mann-Whitney)|||||||<0.001
73818499|NCT00519584|147184764|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
73818500|NCT00519584|147184765|SUPERIORITY|||||||0.29||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)|||||||0.29
73818501|NCT00519584|147184765|SUPERIORITY|||||||0.15||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)|||||||0.15
73818502|NCT05259917|147184787|SUPERIORITY||||||<|0.0001|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||<0.0001
73818503|NCT05259917|147184787|SUPERIORITY|||||||0.0013|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||0.0013
73818504|NCT05259917|147184788|SUPERIORITY|||||||0.0036|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||0.0036
73818505|NCT05259917|147184788|SUPERIORITY|||||||0.0032|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||0.0032
73818506|NCT05259917|147184789|SUPERIORITY|||||||0.0022|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||0.0022
73818507|NCT05259917|147184789|SUPERIORITY||||||<|0.0001|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||<0.0001
73818508|NCT00856843|147184835|SUPERIORITY_OR_OTHER||Difference in success rates|8.8||||0.038|TWO_SIDED|95.0|0.9|16.8|||Chi-squared|||||16.8|0.9|0.038
73818509|NCT00856843|147184836|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
73818510|NCT00856843|147184837|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.020
73818511|NCT00856843|147184838|SUPERIORITY_OR_OTHER|||||||0.644|||||||Chi-squared|||||||0.644
73818512|NCT00856843|147184839|SUPERIORITY_OR_OTHER|||||||0.763|||||||Chi-squared|||||||0.763
73818513|NCT00856843|147184840|SUPERIORITY_OR_OTHER|||||||0.173|||||||Chi-squared|||||||0.173
73818514|NCT00856843|147184841|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||||||0.004
73818515|NCT00856843|147184842|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73818516|NCT00856843|147184843|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
73818517|NCT00856843|147184844|SUPERIORITY_OR_OTHER|||||||0.013|||||||Chi-squared|||||||0.013
73818518|NCT00856843|147184845|SUPERIORITY_OR_OTHER|||||||0.283|||||||Chi-squared|||||||0.283
73818519|NCT02717442|147184852|SUPERIORITY||Risk Ratio (RR)|0.658|||=|0.029|TWO_SIDED|95.0|0.453|0.957||Study week was based on each 4-week interval and was modeled as a categorical variable, and an offset for the log of the number of diary entries recorded for each 4-week interval post-baseline was included for each subject.|Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||0.957|0.453|=0.029
73818520|NCT02717442|147184853|SUPERIORITY||Risk Ratio (RR)|0.59|||=|0.014|TWO_SIDED|95.0|0.388|0.896|||Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||0.896|0.388|=0.014
73818521|NCT02798354|147184860|SUPERIORITY||Risk Difference (RD)|3.9|||<|0.0001|TWO_SIDED|95.0|2.4|5.3|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||5.3|2.4|<0.0001
73818522|NCT02798354|147184861|SUPERIORITY||Risk Difference (RD)|16.0|||<|0.0001|TWO_SIDED|95.0|12.3|20.0|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||20|12.3|<0.0001
73818523|NCT02798354|147184862|SUPERIORITY||Risk Difference (RD)|1.1||||0.302|TWO_SIDED|95.0|-1.0|3.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave|||3.1|-1.0|0.302
73818524|NCT02798354|147184863|SUPERIORITY||Risk Difference (RD)|26.6|||<|0.0001|TWO_SIDED|95.0|22.4|30.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||30.7|22.4|<0.0001
73818525|NCT02798354|147184864|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|16.2|24.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||24.1|16.2|<0.0001
73818526|NCT02798354|147184865|SUPERIORITY||Risk Difference (RD)|14.0|||<|0.0001|TWO_SIDED|95.0|10.3|17.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||17.7|10.3|<0.0001
73818527|NCT02798354|147184866|SUPERIORITY||Risk Difference (RD)|0.1||||0.922|TWO_SIDED|95.0|-1.8|1.9|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave|||1.9|-1.8|0.922
73818528|NCT00528372|147184870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.1522||0.0207||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0207
73818529|NCT00528372|147184870|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1541||0.0005||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0005
73818530|NCT00528372|147184870|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.1518|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
73818531|NCT00528372|147184870|SUPERIORITY_OR_OTHER||Difference from placebo|-0.61|STANDARD_ERROR_OF_MEAN|0.1536|||TWO_SIDED|95.0|-0.91|-0.3||||||||-0.30|-0.91|
73818532|NCT00528372|147184870|SUPERIORITY_OR_OTHER||Difference from placebo|-0.56|STANDARD_ERROR_OF_MEAN|0.1527|||TWO_SIDED|95.0|-0.86|-0.26||||||||-0.26|-0.86|
73818533|NCT00528372|147184870|SUPERIORITY_OR_OTHER||Difference from placebo|-0.56|STANDARD_ERROR_OF_MEAN|0.1474|||TWO_SIDED|95.0|-0.85|-0.27||||||||-0.27|-0.85|
73818534|NCT00528372|147184871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|STANDARD_ERROR_OF_MEAN|5.734||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|||Week 24|||||
73818535|NCT00528372|147184871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|5.806||0.0007||||||Statistically significant according to hierarchical testing procedure (p\<0.05)|ANCOVA||Week 24|||||0.0007
73818536|NCT00528372|147184871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.7|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05)|ANCOVA||Week 24|||||<0.0001
73818537|NCT00528372|147184871|SUPERIORITY_OR_OTHER||Difference from placebo|-21.5|STANDARD_ERROR_OF_MEAN|5.686|||TWO_SIDED|95.0|-32.6|-10.3||||||||-10.3|-32.6|
73818538|NCT00528372|147184871|SUPERIORITY_OR_OTHER||Difference from placebo|-23.3|STANDARD_ERROR_OF_MEAN|5.711|||TWO_SIDED|95.0|-34.4|-12.0||||||||-12.0|-34.4|
73818539|NCT00528372|147184871|SUPERIORITY_OR_OTHER||Difference from placebo|-25.5|STANDARD_ERROR_OF_MEAN|5.567|||TWO_SIDED|95.0|-36.4|-14.5||||||||-14.5|-36.4|
73818540|NCT00528372|147184873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.6307||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.||||||||
73818541|NCT00528372|147184873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.6388||0.3101||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||||0.3101
73818542|NCT00528372|147184873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.6223||0.1189||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||||0.1189
73818543|NCT00528372|147184873|SUPERIORITY_OR_OTHER||Difference from placebo|-1.63|STANDARD_ERROR_OF_MEAN|0.6254|||TWO_SIDED|95.0|-2.86|-0.41||||||||-0.41|-2.86|
73818544|NCT00528372|147184873|SUPERIORITY_OR_OTHER||Difference from placebo|-1.36|STANDARD_ERROR_OF_MEAN|0.6279|||TWO_SIDED|95.0|-2.6|-0.13||||||||-0.13|-2.60|
73818545|NCT00528372|147184873|SUPERIORITY_OR_OTHER||Difference from placebo|-0.87|STANDARD_ERROR_OF_MEAN|0.6103|||TWO_SIDED|95.0|-2.06|0.33||||||||0.33|-2.06|
73818546|NCT00528372|147184875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|4.324||||||||||||||||
73818547|NCT00528372|147184875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|4.342||||||||||||||||
73818548|NCT00528372|147184875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|4.176||||||||||||||||
73818549|NCT00528372|147184875|SUPERIORITY_OR_OTHER||Difference from placebo|-12.0|STANDARD_ERROR_OF_MEAN|4.223|||TWO_SIDED|95.0|-20.3|-3.7||||||||-3.7|-20.3|
73818550|NCT00528372|147184875|SUPERIORITY_OR_OTHER||Difference from placebo|-16.2|STANDARD_ERROR_OF_MEAN|4.321|||TWO_SIDED|95.0|-24.7|-7.7||||||||-7.7|-24.7|
73818551|NCT00528372|147184875|SUPERIORITY_OR_OTHER||Difference from placebo|-17.9|STANDARD_ERROR_OF_MEAN|4.228|||TWO_SIDED|95.0|-26.2|-9.5||||||||-9.5|-26.2|
73818552|NCT00528372|147184877|SUPERIORITY_OR_OTHER||Percentage difference|9.7||||||||||||||||||
73818553|NCT00528372|147184877|SUPERIORITY_OR_OTHER||Percentage difference|12.6||||||||||||||||||
73818554|NCT00528372|147184877|SUPERIORITY_OR_OTHER||Percentage difference|19.2||||||||||||||||||
73818555|NCT00528372|147184877|SUPERIORITY_OR_OTHER||Percent difference from placebo|19.8|||||TWO_SIDED|95.0|4.9|34.7||||||||34.7|4.9|
73818556|NCT00528372|147184877|SUPERIORITY_OR_OTHER||Percent difference from placebo|12.4|||||TWO_SIDED|95.0|-2.5|27.3||||||||27.3|-2.5|
73818557|NCT00528372|147184877|SUPERIORITY_OR_OTHER||Percent difference from placebo|19.9|||||TWO_SIDED|95.0|5.3|34.5||||||||34.5|5.3|
73818558|NCT00528372|147184878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.6979||||||||||||||||
73818559|NCT00528372|147184878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|0.6828||||||||||||||||
73818560|NCT00528372|147184878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.6404||||||||||||||||
73818561|NCT00528372|147184878|SUPERIORITY_OR_OTHER||Difference from placebo|-1.55|STANDARD_ERROR_OF_MEAN|0.7394|||TWO_SIDED|95.0|-3.33|-0.42||||||||-0.42|-3.33|
73818562|NCT00528372|147184878|SUPERIORITY_OR_OTHER||Difference from placebo|-1.27|STANDARD_ERROR_OF_MEAN|0.7257|||TWO_SIDED|95.0|-2.69|0.16||||||||0.16|-2.69|
73818563|NCT00528372|147184878|SUPERIORITY_OR_OTHER||Difference from placebo|-0.87|STANDARD_ERROR_OF_MEAN|0.6103|||TWO_SIDED|95.0|-2.06|0.33||||||||0.33|-2.06|
73818564|NCT00528372|147184879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.175||||||||||||||||
73818565|NCT00528372|147184879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.175||||||||||||||||
73818566|NCT00528372|147184879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.1708||||||||||||||||
73818567|NCT00528372|147184879|SUPERIORITY_OR_OTHER||Difference from placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.1798|||TWO_SIDED|95.0|-0.95|-0.25||||||||-0.25|-0.95|
73818568|NCT00528372|147184879|SUPERIORITY_OR_OTHER||Difference from placebo|-0.55|STANDARD_ERROR_OF_MEAN|0.1741|||TWO_SIDED|95.0|-0.89|-0.21||||||||-0.21|-0.89|
73818569|NCT00528372|147184879|SUPERIORITY_OR_OTHER||Difference from placebo|-0.58|STANDARD_ERROR_OF_MEAN|0.1704|||TWO_SIDED|95.0|-0.92|-0.25||||||||-0.25|-0.92|
73818570|NCT00528372|147184880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_ERROR_OF_MEAN|6.526||||||||||||||||
73818571|NCT00528372|147184880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|6.761||||||||||||||||
73818572|NCT00528372|147184880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|6.334||||||||||||||||
73818573|NCT00528372|147184880|SUPERIORITY_OR_OTHER||Percent difference from placebo|18.8|||||TWO_SIDED|95.0|5.5|32.1||||||||32.1|5.5|
73818574|NCT00528372|147184880|SUPERIORITY_OR_OTHER||Percent difference from placebo|11.3|||||TWO_SIDED|95.0|-1.8|24.4||||||||24.4|-1.8|
73818575|NCT00528372|147184880|SUPERIORITY_OR_OTHER||Percent difference from placebo|11.4|||||TWO_SIDED|95.0|-1.0|23.9||||||||23.9|-1.0|
73818576|NCT00528372|147184881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.736||||||||||||||||
73818577|NCT00528372|147184881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.7371||||||||||||||||
73818578|NCT00528372|147184881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.7078||||||||||||||||
73818579|NCT00528372|147184881|SUPERIORITY_OR_OTHER||Difference from placebo|-1.87|STANDARD_ERROR_OF_MEAN|0.7394|||TWO_SIDED|95.0|-3.33|-0.42||||||||-0.42|-3.33|
73818580|NCT00528372|147184881|SUPERIORITY_OR_OTHER||Difference from placebo|-1.27|STANDARD_ERROR_OF_MEAN|0.7257|||TWO_SIDED|95.0|-2.69|0.16||||||||0.16|-2.69|
73818581|NCT00528372|147184881|SUPERIORITY_OR_OTHER||Difference from placebo|-0.97|STANDARD_ERROR_OF_MEAN|0.7135||||95.0|-2.37|0.44||||||||0.44|-2.37|
73818582|NCT02774005|147184899|SUPERIORITY||Odds Ratio (OR)|2.286||||0.0021|TWO_SIDED|95.0|1.352|3.884|||Wald Chi-square|||||3.884|1.352|0.0021
73818583|NCT02774005|147184900|SUPERIORITY||Odds Ratio (OR)|1.646||||0.0873|TWO_SIDED|95.0|0.929|2.918|||Waldi-Chi-Square|||||2.918|0.929|0.0873
73818584|NCT02774005|147184901|SUPERIORITY||Odds Ratio (OR)|7.323||||0.0005|TWO_SIDED|95.0|2.339|25.912|||Waldi-Chi-Square|||||25.912|2.339|0.0005
73818585|NCT02379273|147184909|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||A Friedman repeated-measures ANOVA on ranks was applied to the unilateral CNC data with follow-up pairwise comparisons based on the Tukey Test.||||<0.001
73818586|NCT02379273|147184909|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the bilateral CNC data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
73818587|NCT02379273|147184910|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the unilateral AzBio data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
73818588|NCT02379273|147184910|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the bilateral AzBio data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
73818589|NCT02379273|147184911|SUPERIORITY|A one-way repeated-measures analysis of variance was applied to the data, with follow-up pairwise comparisons based on the Holm-Sidak method.|||||<|0.001||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||<0.001
73818590|NCT02379273|147184912|SUPERIORITY|A one-way repeated-measures analysis of variance was applied to the data, with follow-up pairwise comparisons based on the Holm-Sidak method.|||||<|0.001|||||||ANOVA|The threshold for statistical significance was p=0.05.||||||<0.001
73818591|NCT02379273|147184913|SUPERIORITY|Pre- and postoperative mean scores were compared based on Friedman repeated-measures analysis of variance with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||<0.001
73818592|NCT03275389|147184953|EQUIVALENCE|The use of the adjuvant (AS03) is to be considered justified if the lower limit of the 94.46% CI of the GMC ratio (adjuvanted vs non-adjuvanted) is \> 1.50|GMC ratio|2.47|||||TWO_SIDED|94.46|2.06|2.95|||Dunnett's t test|Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,||To evaluate the adjuvant effect of AS03 (Pooling of results at Day 29 of D-SUIV Adjuvant Group 1, at Day 29 of D-SUIV Adjuvant Group 2 and Day 85 of D-SUIV Adjuvant Group 3) on the humoral immune response for anti-H1 stalk antibody by ELISA at Day 29 and Day 85 (i.e. 28 days post-vaccination) when compared to the non-adjuvanted formulations (Pooling of results at Day 29 of D-SUIV Unadjuvanted Group 1, at Day 29 of D-SUIV Unadjuvanted Group 2 and Day 85 of D-SUIV Unadjuvanted Group 3).||2.95|2.06|
73818593|NCT03275389|147184953|EQUIVALENCE|The use of the adjuvant (AS01) is to be considered justified if the lower limit of the 94.46% CI of the GMC ratio (adjuvanted vs non-adjuvanted) is \> 1.50|GMC ratio|1.75|||||TWO_SIDED|94.46|1.46|2.1|||Dunnett's t test|Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,||To evaluate the adjuvant effect of AS01 (Pooling of results at Day 29 of D-SUIV Adjuvant Group 4, at Day 29 of D-SUIV Adjuvant Group 5 and Day 85 of D-SUIV Adjuvant Group 6) on the humoral immune response for anti-H1 stalk antibody by ELISA at Day 29 and Day 85 (i.e. 28 days post-vaccination) when compared to the non-adjuvanted formulations (Pooling of results at Day 29 of D-SUIV Unadjuvanted Group 1, at Day 29 of D-SUIV Unadjuvanted Group 2 and Day 85 of D-SUIV Unadjuvanted Group 3).||2.1|1.46|
73818594|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.462||0.6797||95.0|-0.83|1.22|||ANOVA|||Difference from placebo (including Baseline), Day 1: 0.5 hours post-dose.||1.22|-0.83|0.6797
73818595|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.528||0.4811||95.0|-1.54|0.77|||ANOVA|||Difference from placebo (including Baseline), Day 1: 1 hour post-dose.||0.77|-1.54|0.4811
73818596|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.454||0.1693||95.0|-1.67|0.33|||ANOVA|||Difference from placebo (including Baseline), Day 1: 2 hours post-dose.||0.33|-1.67|0.1693
73818597|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.487||0.4034||95.0|-1.78|0.87|||ANOVA|||Difference from placebo (including Baseline) , Day 1: 3 hours post-dose.||0.87|-1.78|0.4034
73818598|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.694||0.1935||95.0|-2.36|0.5|||ANOVA|||Difference from placebo (including Baseline), Day 1: 4 hours post-dose.||0.50|-2.36|0.1935
73818599|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.715||0.0694||95.0|-2.83|0.12|||ANOVA|||Difference from placebo (including Baseline), Day 1: 5 hours post-dose.||0.12|-2.83|0.0694
73818600|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.713||0.0396||95.0|-3.02|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 1: 6 hours post-dose.||-0.08|-3.02|0.0396
73818601|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.319||0.1531||95.0|-1.25|0.24|||ANOVA|||Difference from placebo (including Baseline), Day 1: 8 hours post-dose.||0.24|-1.25|0.1531
73818602|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.637||0.0951||95.0|-2.79|0.29|||ANOVA|||Difference from placebo (including Baseline), Day 1: 10 hours post-dose.||0.29|-2.79|0.0951
73818603|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.615||0.0614||95.0|-2.84|0.09|||ANOVA|||Difference from placebo (including Baseline), Day 1: 12 hours post-dose.||0.09|-2.84|0.0614
73818604|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.619||0.1946||95.0|-2.29|0.54|||ANOVA|||Difference from placebo (including Baseline), Day 8: pre-dose.||0.54|-2.29|0.1946
73818605|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.553||0.2843||95.0|-2.2|0.84|||ANOVA|||Difference from placebo (including Baseline), Day 8: 0.5 hours post-dose.||0.84|-2.20|0.2843
73818606|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.82||0.215||95.0|-2.75|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 1 hour post-dose.||0.65|-2.75|0.2150
73818607|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.189||0.9601||95.0|-0.44|0.42|||ANOVA|||Difference from placebo (including Baseline), Day 8: 2 hours post-dose.||0.42|-0.44|0.9601
73818608|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.311||0.867||95.0|-0.64|0.74|||ANOVA|||Difference from placebo (including baseline), Day 8: 3 hours post-dose.||0.74|-0.64|0.8670
73818609|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.393||0.9024||95.0|-0.94|0.84|||ANOVA|||Difference from placebo (including baseline), Day 8: 4 hours post-dose.||0.84|-0.94|0.9024
73818610|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.293||0.9708||95.0|-0.67|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 5 hours post-dose.||0.65|-0.67|0.9708
73818611|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.395||0.1078||95.0|-1.62|0.19|||ANOVA|||Difference from placebo (including Baseline), Day 8: 6 hours post-dose.||0.19|-1.62|0.1078
73818612|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.419||0.446||95.0|-1.28|0.61|||ANOVA|||Difference from placebo (including Baseline), Day 8: 8 hours post-dose.||0.61|-1.28|0.4460
73818613|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.394||0.5266||95.0|-1.13|0.62|||ANOVA|||Difference from placebo (including Baseline), Day 8: 10 hours post-dose.||0.62|-1.13|0.5266
73818614|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.273||0.029||95.0|-1.29|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 8: 12 hours post-dose.||-0.08|-1.29|0.0290
73818615|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.531||0.183||95.0|-2.01|0.45|||ANOVA|||Difference from placebo (including Baseline), Day 8: 24 hours post-dose.||0.45|-2.01|0.1830
73818616|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.406||0.9884||95.0|-0.9|0.91|||ANOVA|||Difference from placebo (including Baseline), Day 8: 36 hours post-dose.||0.91|-0.90|0.9884
73818617|NCT00978341|147184969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.354||0.8082||95.0|-0.87|0.69|||ANOVA|||Difference from placebo (including Baseline), Day 8: 48 hours post-dose.||0.69|-0.87|0.8082
73818618|NCT00978341|147184970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.714||0.2101||95.0|-2.39|0.55|||ANOVA|||Difference from placebo (including baseline); Day 2. Combined analysis: values for the two patient groups were analyzed together using ANOVA and/or mixed models.||0.55|-2.39|0.2101
73818619|NCT00978341|147184970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.623||0.1065||95.0|-2.33|0.24|||ANOVA|||Difference from placebo (including baseline); Day 3.||0.24|-2.33|0.1065
73818620|NCT00978341|147184970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.254||0.0697||95.0|-1.11|0.05|||ANOVA|||Difference from placebo (including baseline); Day 4.||0.05|-1.11|0.0697
73818621|NCT00978341|147184970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.65||0.4589||95.0|-1.83|0.85|||ANOVA|||Difference from placebo; Day 5.||0.85|-1.83|0.4589
73818622|NCT00978341|147184970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.742||0.1326||95.0|-2.69|0.38|||ANOVA|||Difference from placebo; Day 6.||0.38|-2.69|0.1326
73818623|NCT00978341|147184970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.638||0.282||95.0|-2.45|0.9|||ANOVA|||Difference from placebo (including baseline); Day 7.||0.90|-2.45|0.2820
73818624|NCT00978341|147184970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.356||0.0108||95.0|-2.21|-0.44|||ANOVA|||Difference from placebo (including baseline); Day 8.||-0.44|-2.21|0.0108
73818625|NCT00978341|147184971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.26|STANDARD_ERROR_OF_MEAN|19.06||0.9068||95.0|-41.78|37.27|||ANOVA|||Difference from placebo; Day 1: 4 hours post-dose (including Baseline).||37.27|-41.78|0.9068
73818626|NCT00978341|147184971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|15.813||0.7807||95.0|-30.53|39.57|||ANOVA|||Difference from placebo; Day 8: pre-dose (including Baseline).||39.57|-30.53|0.7807
73818627|NCT00978341|147184971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.51|STANDARD_ERROR_OF_MEAN|17.526||0.2293||95.0|-61.79|16.78|||ANOVA|||Difference from placebo; Day 8: 4 hours post-dose (including Baseline).||16.78|-61.79|0.2293
73818628|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.386||0.3774||95.0|-0.54|1.27|||ANOVA|||Difference from placebo (including Baseline); Day 1: 0.5 hours post-dose.||1.27|-0.54|0.3774
73818629|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.215||0.4153||95.0|-0.33|0.7|||ANOVA|||Difference from placebo (including Baseline); Day 1: 1 hour post-dose.||0.70|-0.33|0.4153
73818630|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48||||0.147||95.0|-0.23|1.2|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.||1.20|-0.23|0.1470
73818631|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.3||0.1862||95.0|-1.18|0.29|||ANOVA|||Difference from placebo (including Baseline); Day 1: 3 hours post-dose.||0.29|-1.18|0.1862
73818632|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.22||0.8321||95.0|-0.45|0.55|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.||0.55|-0.45|0.8321
73818633|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.269||0.4251||95.0|-0.42|0.88|||ANOVA|||Difference from placebo (including Baseline); Day 1: 5 hours post-dose.||0.88|-0.42|0.4251
73818634|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.269||0.6394||95.0|-0.53|0.8|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.||0.80|-0.53|0.6394
73818635|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.302||0.9964||95.0|-0.68|0.68|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||0.68|-0.68|0.9964
73818636|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.324||0.3638||95.0|-0.47|1.11|||ANOVA|||Difference from placebo (including Baseline); Day 8: 0.5 hours post-dose.||1.11|-0.47|0.3638
73818637|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.223||0.1202||95.0|-0.15|0.99|||ANOVA|||Difference from placebo (including Baseline); Day 8: 1 hour post-dose.||0.99|-0.15|0.1202
73818638|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.355||0.1204||95.0|-0.19|1.39|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.||1.39|-0.19|0.1204
73818639|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.289||0.4213||95.0|-0.44|0.93|||ANOVA|||Difference from placebo (including Baseline); Day 8: 3 hours post-dose.||0.93|-0.44|0.4213
73818640|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.205||0.6028||95.0|-0.34|0.56|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||0.56|-0.34|0.6028
73818641|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.491||0.3624||95.0|-0.68|1.64|||ANOVA|||Difference from placebo (including Baseline); Day 8: 5 hours post-dose.||1.64|-0.68|0.3624
73818642|NCT00978341|147184972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.461||0.3163||95.0|-0.52|1.49|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.||1.49|-0.52|0.3163
73818643|NCT00978341|147184973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|9.738||0.5919||95.0|-16.26|27.04|||ANOVA|||Difference from placebo (including Baseline); Day 1.||27.04|-16.26|0.5919
73818644|NCT00978341|147184973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.58|STANDARD_ERROR_OF_MEAN|14.603||0.3981||95.0|-17.7|42.87|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||42.87|-17.70|0.3981
73818645|NCT00978341|147184973|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64|STANDARD_ERROR_OF_MEAN|12.123||0.8314||95.0|-24.0|29.28|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||29.28|-24.00|0.8314
73818646|NCT00978341|147184974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.054||0.7569||95.0|-0.14|0.1|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.||0.10|-0.14|0.7569
73818647|NCT00978341|147184974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4814||95.0|-0.26|0.13|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.||0.13|-0.26|0.4814
73818648|NCT00978341|147184974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.143||0.6222||95.0|-0.37|0.23|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.||0.23|-0.37|0.6222
73818649|NCT00978341|147184974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.113||0.3035||95.0|-0.35|0.12|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||0.12|-0.35|0.3035
73818650|NCT00978341|147184974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.122||0.1881||95.0|-0.42|0.09|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.||0.09|-0.42|0.1881
73818651|NCT00978341|147184974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.072||0.3159||95.0|-0.09|0.24|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||0.24|-0.09|0.3159
73818652|NCT00978341|147184974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.103||0.8203||95.0|-0.22|0.27|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.||0.27|-0.22|0.8203
73818653|NCT03035916|147184981|OTHER|||||||0.454|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.454
73818654|NCT03035916|147184981|OTHER|||||||0.402|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.402
73818655|NCT03035916|147184981|OTHER|||||||0.901|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.901
73818656|NCT03035916|147184981|OTHER|||||||0.54|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.540
73818657|NCT03035916|147184981|OTHER|||||||0.523|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.523
73818658|NCT03035916|147184981|OTHER|||||||0.26|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.260
73818659|NCT03035916|147184981|OTHER|||||||0.139|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.139
73818660|NCT03035916|147184981|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
73818661|NCT03035916|147184981|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
73818662|NCT03035916|147184981|OTHER|||||||0.464|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.464
73818663|NCT03035916|147184981|OTHER|||||||0.007|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.007
73818664|NCT03035916|147184981|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
73818665|NCT03035916|147184981|OTHER|||||||0.411|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.411
73818666|NCT03035916|147184981|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
73818667|NCT03035916|147184981|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
73818668|NCT03035916|147184982|OTHER|||||||0.412|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.412
73818669|NCT03035916|147184982|OTHER|||||||0.592|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.592
73818670|NCT03035916|147184982|OTHER|||||||0.796|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.796
73818671|NCT03035916|147184982|OTHER|||||||0.576|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.576
73818672|NCT03035916|147184982|OTHER|||||||0.427|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.427
73818673|NCT03035916|147184982|OTHER|||||||0.201|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.201
73818674|NCT03035916|147184982|OTHER|||||||0.872|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.872
73818675|NCT03035916|147184982|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
73818676|NCT03035916|147184982|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
73818677|NCT03035916|147184982|OTHER|||||||0.165|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.165
73818678|NCT03035916|147184982|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
73818679|NCT03035916|147184982|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
73818680|NCT03035916|147184982|OTHER|||||||0.305|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.305
73818681|NCT03035916|147184982|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
73818682|NCT03035916|147184982|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
73818683|NCT03035916|147184983|OTHER|||||||0.673|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.673
73818684|NCT03035916|147184983|OTHER|||||||0.824|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.824
73818685|NCT03035916|147184983|OTHER|||||||0.547|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.547
73818686|NCT03035916|147184983|OTHER|||||||0.303|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.303
73818687|NCT03035916|147184983|OTHER|||||||0.026|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.026
73818688|NCT03035916|147184983|OTHER|||||||0.002|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.002
73818689|NCT03035916|147184983|OTHER|||||||0.057|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.057
73818690|NCT03035916|147184983|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
73818691|NCT03035916|147184983|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
73818692|NCT03035916|147184983|OTHER|||||||0.069|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.069
73818693|NCT03035916|147184983|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
73818694|NCT03035916|147184983|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
73818695|NCT03035916|147184983|OTHER|||||||0.561|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.561
73818696|NCT03035916|147184983|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
73818697|NCT03035916|147184983|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
73818698|NCT03035916|147184984|OTHER|||||||0.249|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.249
73818699|NCT03035916|147184984|OTHER|||||||0.091|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.091
73818700|NCT03035916|147184984|OTHER|||||||0.493|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.493
73818701|NCT03035916|147184984|OTHER|||||||0.067|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.067
73818702|NCT03035916|147184984|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.001
73818703|NCT03035916|147184984|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.001
73818704|NCT03035916|147184984|OTHER|||||||0.079|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.079
73818705|NCT03035916|147184984|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
73818706|NCT03035916|147184984|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
73818707|NCT03035916|147184984|OTHER|||||||0.314||||||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.314
73818708|NCT03035916|147184984|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
73818709|NCT03035916|147184984|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
73818710|NCT03035916|147184984|OTHER|||||||0.087|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.087
73818711|NCT03035916|147184984|OTHER|||||||0.023|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.023
73818712|NCT03035916|147184984|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
73818713|NCT03035916|147184985|OTHER|||||||0.384|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.384
73818714|NCT03035916|147184985|OTHER|||||||0.53|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.530
73818715|NCT03035916|147184985|OTHER|||||||0.819|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.819
73818716|NCT03035916|147184985|OTHER|||||||0.108|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.108
73818717|NCT03035916|147184985|OTHER|||||||0.667|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.667
73818718|NCT03035916|147184985|OTHER|||||||0.046|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.046
73818719|NCT03035916|147184985|OTHER|||||||0.006|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.006
73818720|NCT03035916|147184985|OTHER|||||||0.406|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.406
73818721|NCT03035916|147184985|OTHER|||||||0.042|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.042
73818722|NCT03035916|147184985|OTHER|||||||0.655|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.655
73818723|NCT03035916|147184985|OTHER|||||||0.262|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.262
73818724|NCT03035916|147184985|OTHER|||||||0.143|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.143
73818725|NCT03035916|147184985|OTHER|||||||0.494|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.494
73818726|NCT03035916|147184985|OTHER|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
73818727|NCT03035916|147184985|OTHER|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
73818728|NCT03035916|147184985|OTHER|||||||0.555|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.555
73818729|NCT03035916|147184985|OTHER|||||||0.411|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.411
73818730|NCT03035916|147184985|OTHER|||||||0.167|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.167
73818731|NCT03035916|147184985|OTHER|||||||0.445|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.445
73818732|NCT03035916|147184985|OTHER|||||||0.489|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.489
73818733|NCT03035916|147184985|OTHER|||||||0.159|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.159
73818734|NCT03035916|147184985|OTHER|||||||0.72|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.720
73818735|NCT03035916|147184985|OTHER|||||||0.026|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.026
73818736|NCT03035916|147184985|OTHER|||||||0.011|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.011
73818737|NCT03035916|147184985|OTHER|||||||0.763|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.763
73818738|NCT03035916|147184985|OTHER|||||||0.187|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.187
73818739|NCT03035916|147184985|OTHER|||||||0.112|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.112
73818740|NCT03035916|147184986|OTHER|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.645
73818741|NCT03035916|147184986|OTHER|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.645
73818742|NCT03035916|147184986|OTHER|||||||0.314|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.314
73818743|NCT03035916|147184986|OTHER|||||||0.003|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.003
73818744|NCT03035916|147184986|OTHER|||||||0.367|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.367
73818745|NCT03035916|147184986|OTHER|||||||0.031|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.031
73818746|NCT03035916|147184986|OTHER|||||||0.009|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.009
73818747|NCT03035916|147184986|OTHER|||||||0.873|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.873
73818748|NCT03035916|147184986|OTHER|||||||0.026|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.026
73818749|NCT03035916|147184986|OTHER|||||||0.411|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.411
73818750|NCT03035916|147184986|OTHER|||||||0.787|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.787
73818751|NCT03035916|147184986|OTHER|||||||0.306|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.306
73818752|NCT03035916|147184986|OTHER|||||||0.921|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.921
73818753|NCT03035916|147184986|OTHER|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
73818754|NCT03035916|147184986|OTHER|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
73818755|NCT03035916|147184986|OTHER|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.555
73818756|NCT03035916|147184986|OTHER|||||||0.058|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.058
73818757|NCT03035916|147184986|OTHER|||||||0.166|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.166
73818758|NCT03035916|147184986|OTHER|||||||0.288|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.288
73818759|NCT03035916|147184986|OTHER|||||||0.299|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.299
73818760|NCT03035916|147184986|OTHER|||||||0.051|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.051
73818761|NCT03035916|147184986|OTHER|||||||0.186|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.186
73818762|NCT03035916|147184986|OTHER|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.555
73818763|NCT03035916|147184986|OTHER|||||||0.065|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.065
73818764|NCT03035916|147184986|OTHER|||||||0.168|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.168
73818765|NCT03035916|147184986|OTHER|||||||0.739|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.739
73818766|NCT03035916|147184986|OTHER|||||||0.079|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.079
73818767|NCT03035916|147184987|OTHER|||||||0.056|||||||t-test, 2 sided|||||||0.056
73818768|NCT03035916|147184987|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
73818769|NCT03035916|147184987|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
73818770|NCT03035916|147184988|OTHER|||||||0.056||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.056
73818771|NCT03035916|147184988|OTHER|||||||0.009||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.009
73818772|NCT03035916|147184988|OTHER|||||||0.001||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.001
73818773|NCT03035916|147184988|OTHER|||||||0.198|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.198
73818774|NCT03035916|147184988|OTHER|||||||0.047|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.047
73818775|NCT03035916|147184988|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.002
73818776|NCT03035916|147184988|OTHER|||||||0.102|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.102
73818777|NCT03035916|147184988|OTHER|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.005
73818778|NCT03035916|147184988|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
73818779|NCT03035916|147184988|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
73818780|NCT03035916|147184988|OTHER|||||||0.023|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.023
73818781|NCT03035916|147184988|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
73818782|NCT03035916|147184988|OTHER|||||||0.425|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.425
73818783|NCT03035916|147184988|OTHER|||||||0.124|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.124
73818784|NCT03035916|147184988|OTHER|||||||0.052|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.052
73818785|NCT03035916|147184989|OTHER|||||||0.176||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.176
73818786|NCT03035916|147184989|OTHER|||||||0.001||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.001
73818787|NCT03035916|147184989|OTHER|||||||0.228|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.228
73818788|NCT03035916|147184989|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
73818789|NCT03035916|147184989|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
73818790|NCT03035916|147184989|OTHER|||||||0.057|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.057
73818791|NCT03035916|147184989|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
73818792|NCT03035916|147184989|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
73818793|NCT03035916|147184989|OTHER|||||||0.004|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.004
73818794|NCT03035916|147184989|OTHER|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.005
73818795|NCT03035916|147184989|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
73818796|NCT03035916|147184989|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.002
73818797|NCT03035916|147184989|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.002
73818798|NCT03035916|147184989|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
73818799|NCT03035916|147184990|OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
73818800|NCT03035916|147184990|OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
73818801|NCT03035916|147184990|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
73818802|NCT03035916|147184991|OTHER|||||||0.644|||||||t-test, 2 sided|||||||0.644
73818803|NCT03035916|147184991|OTHER|||||||0.045|||||||t-test, 2 sided|||||||0.045
73818804|NCT03035916|147184991|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
73818805|NCT03035916|147184992|OTHER|||||||0.421|||||||t-test, 2 sided|||||||0.421
73818806|NCT03035916|147184992|OTHER|||||||0.046|||||||t-test, 2 sided|||||||0.046
73818807|NCT03035916|147184992|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
73818808|NCT03035916|147184993|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.910
73818809|NCT03035916|147184993|OTHER|||||||0.864|||||||t-test, 2 sided|||||||0.864
73818810|NCT03035916|147184993|OTHER|||||||0.785|||||||t-test, 2 sided|||||||0.785
73818811|NCT03035916|147184994|OTHER|||||||0.972|||||||t-test, 2 sided|||||||0.972
73818812|NCT03035916|147184994|OTHER|||||||0.987|||||||t-test, 2 sided|||||||0.987
73818813|NCT03035916|147184994|OTHER|||||||0.518|||||||t-test, 2 sided|||||||0.518
73818814|NCT03749109|147185003|OTHER||Difference in LS mean|1.74||||0.78|TWO_SIDED|95.0|-10.45|13.94|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||13.94|-10.45|0.78
73818815|NCT03749109|147185003|OTHER||Difference in LS mean|3.35||||0.29|TWO_SIDED|95.0|-2.89|9.59|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||9.59|-2.89|0.29
73818816|NCT03749109|147185003|OTHER||Difference in LS mean|0.33||||0.95|TWO_SIDED|95.0|-10.33|10.99|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis||10.99|-10.33|0.95
73818817|NCT03749109|147185004|OTHER||Difference in LS mean|-6.99||||0.65|TWO_SIDED|95.0|-36.8|22.82|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||22.82|-36.80|0.65
73818818|NCT03749109|147185004|OTHER||Difference in LS mean|-1.13||||0.92|TWO_SIDED|95.0|-22.77|20.51|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||20.51|-22.77|0.92
73818819|NCT03749109|147185004|OTHER||Difference in LS mean|-5.92||||0.74|TWO_SIDED|95.0|-40.94|29.1|||ANCOVA|ANCOVA adjusted for baseline lesion size.||||29.10|-40.94|0.74
73818820|NCT03749109|147185005|OTHER||Odds Ratio (OR)|1.04||||0.95|TWO_SIDED|95.0|0.38|2.82|||Regression, Logistic|||Endometrioma||2.82|0.38|0.95
73818821|NCT03749109|147185005|OTHER||Odds Ratio (OR)|0.55||||0.39|TWO_SIDED|95.0|0.14|2.17|||Regression, Logistic|||Adenomyosis||2.17|0.14|0.39
73818822|NCT03749109|147185006|OTHER||Odds Ratio (OR)|0.7||||0.6|TWO_SIDED|95.0|0.19|2.65|||Regression, Logistic|||Endometrioma||2.65|0.19|0.60
73818823|NCT03749109|147185006|OTHER||Odds Ratio (OR)|0.35||||0.21|TWO_SIDED|95.0|0.07|1.79|||Regression, Logistic|||Adenomyosis||1.79|0.07|0.21
73818824|NCT03749109|147185007|OTHER||Rate Ratio|2.53||||0.13|TWO_SIDED|95.0|0.76|8.39|||Negative-binomial regression|||Endometrioma - Disappearing Lesions||8.39|0.76|0.13
73818825|NCT03749109|147185007|OTHER||Rate Ratio|0.49||||0.56|TWO_SIDED|95.0|0.04|5.41|||Negative-binomial regression|||Adenomyosis - Disappearing Lesions||5.41|0.04|0.56
73818826|NCT03749109|147185008|OTHER||Difference in LS mean|0.23||||0.97|TWO_SIDED|95.0|-12.78|13.23|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||13.23|-12.78|0.97
73818827|NCT03749109|147185008|OTHER||Difference in LS mean|0.72||||0.74|TWO_SIDED|95.0|-3.63|5.07|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||5.07|-3.63|0.74
73818828|NCT03749109|147185009|OTHER||Difference in LS mean|10.13||||0.42|TWO_SIDED|95.0|-14.74|35.0|||ANCOVA|ANCOVA adjusted for baseline lesion size.||||35.00|-14.74|0.42
73818829|NCT03749109|147185010|OTHER||Difference in LS mean|1.09||||0.1|TWO_SIDED|95.0|-0.2|2.38|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||2.38|-0.20|0.10
73818830|NCT03749109|147185010|OTHER||Difference in LS mean|0.28||||0.67|TWO_SIDED|95.0|-1.02|1.58|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||1.58|-1.02|0.67
73818831|NCT03749109|147185010|OTHER||Difference in LS mean|0.32||||0.64|TWO_SIDED|95.0|-1.06|1.71|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis||1.71|-1.06|0.64
73818832|NCT03749109|147185011|OTHER||Difference in LS mean|0.21||||0.73|TWO_SIDED|95.0|-1.02|1.44|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 1||1.44|-1.02|0.73
73818833|NCT03749109|147185011|OTHER||Difference in LS mean|0.42||||0.54|TWO_SIDED|95.0|-0.97|1.82|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 2||1.82|-0.97|0.54
73818834|NCT03749109|147185011|OTHER||Difference in LS mean|-0.5||||0.46|TWO_SIDED|95.0|-1.86|0.85|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 3||0.85|-1.86|0.46
73818835|NCT03749109|147185011|OTHER||Difference in LS mean|0.53||||0.49|TWO_SIDED|95.0|-0.99|2.05|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 4||2.05|-0.99|0.49
73818836|NCT03749109|147185011|OTHER||Difference in LS mean|-0.01||||0.99|TWO_SIDED|95.0|-1.32|1.3|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 1||1.30|-1.32|0.99
73818837|NCT03749109|147185011|OTHER||Difference in LS mean|0.17||||0.83|TWO_SIDED|95.0|-1.38|1.71|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 2||1.71|-1.38|0.83
73818838|NCT03749109|147185011|OTHER||Difference in LS mean|-0.74||||0.28|TWO_SIDED|95.0|-2.11|0.63|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 3||0.63|-2.11|0.28
73818839|NCT03749109|147185011|OTHER||Difference in LS mean|0.75||||0.26|TWO_SIDED|95.0|-0.57|2.07|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 4||2.07|-0.57|0.26
73818840|NCT03749109|147185011|OTHER||Difference in LS mean|0.91||||0.19|TWO_SIDED|95.0|-0.49|2.31|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 1||2.31|-0.49|0.19
73818841|NCT03749109|147185011|OTHER||Difference in LS mean|0.07||||0.93|TWO_SIDED|95.0|-1.45|1.58|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 2||1.58|-1.45|0.93
73818842|NCT03749109|147185011|OTHER||Difference in LS mean|-0.13||||0.85|TWO_SIDED|95.0|-1.58|1.32|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 3||1.32|-1.58|0.85
73818843|NCT03749109|147185011|OTHER||Difference in LS mean|0.01||||0.99|TWO_SIDED|95.0|-1.68|1.69|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 4||1.69|-1.68|0.99
73818844|NCT03749109|147185012|OTHER||Difference in LS mean|-7.35||||0.75|TWO_SIDED|95.0|-53.97|39.27|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 2||39.27|-53.97|0.75
73818845|NCT03749109|147185012|OTHER||Difference in LS mean|17.31||||0.42|TWO_SIDED|95.0|-25.41|60.04|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 4||60.04|-25.41|0.42
73818846|NCT03749109|147185012|OTHER||Difference in LS mean|-17.66||||0.47|TWO_SIDED|95.0|-66.3|30.98|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 2||30.98|-66.30|0.47
73818847|NCT03749109|147185012|OTHER||Difference in LS mean|25.61||||0.27|TWO_SIDED|95.0|-21.05|72.27|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 4||72.27|-21.05|0.27
73818848|NCT03749109|147185012|OTHER||Difference in LS mean|-20.95||||0.41|TWO_SIDED|95.0|-71.83|29.92|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 2||29.92|-71.83|0.41
73818849|NCT03749109|147185012|OTHER||Difference in LS mean|2.25||||0.93|TWO_SIDED|95.0|-49.57|54.06|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 4||54.06|-49.57|0.93
73818850|NCT02636439|147185053|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.21|TWO_SIDED|95.0|-25.0|112.0|||ANCOVA|adjusted for baseline value, age, and sex.||||112|-25|0.21
73818851|NCT02636439|147185054|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.8|-1.0|0.86
73818852|NCT02636439|147185055|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.77|TWO_SIDED|95.0|-2.8|3.8|||ANCOVA|Adjusted for baseline value, age, and sex.||||3.8|-2.8|0.77
73818853|NCT02636439|147185056|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.85|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.2|-0.3|0.85
73818854|NCT02636439|147185057|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.053|TWO_SIDED|95.0|-0.1|12.9|||ANCOVA|Adjusted for baseline value, age, and sex.||||12.9|-0.1|0.053
73818855|NCT02636439|147185058|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.043|TWO_SIDED|95.0|0.0|0.13|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.13|0.00|0.043
73818856|NCT02636439|147185059|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.07|TWO_SIDED|95.0|-10.0|0.0|||ANCOVA|Adjusted for baseline value, age, and sex.||||0|-10|0.07
73818857|NCT02636439|147185060|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.79|TWO_SIDED|95.0|-4.4|3.3|||ANCOVA|Adjusted for baseline value, age, and sex.||||3.3|-4.4|0.79
73818858|NCT04679948|147185063|OTHER||Ratio of GLSMs [%]|112.06|||||TWO_SIDED|90.0|101.02|124.3|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + caffeine/GLSM of caffeine). Intra-individual geometric coefficient of variation (gCV \[%\]) =16.2."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||124.30|101.02|
73818859|NCT04679948|147185064|OTHER||Ratio of GLSMs [%]|96.74|||||TWO_SIDED|90.0|91.55|102.23|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + caffeine/GLSM of caffeine). Intra-individual geometric coefficient of variation (gCV \[%\]) = 8.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||102.23|91.55|
73818860|NCT04679948|147185065|OTHER||Ratio of GLSMs [%]|110.38|||||TWO_SIDED|90.0|107.15|113.71|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + warfarin/GLSM of Warfarin). Intra-individual geometric coefficient of variation (gCV \[%\]) =4.8."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.71|107.15|
73896513|NCT00913458|147326252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.59||||0.0024|TWO_SIDED|95.0|-27.1|-6.0|||Longitudinal statisitical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-6.0|-27.1|0.0024
73896514|NCT00913458|147326252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.85||||0.0621|TWO_SIDED|95.0|-20.2|0.5|||Longitudinal statistical model|||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.5|-20.2|0.0621
73818861|NCT04679948|147185066|OTHER||Ratio of GLSMs [%]|108.47|||||TWO_SIDED|90.0|104.11|113.01|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + warfarin/GLSM of Warfarin). Intra-individual geometric coefficient of variation (gCV \[%\]) = 6.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.01|104.11|
73818862|NCT04679948|147185067|OTHER||Ratio of GLSM [%]|99.74|||||TWO_SIDED|90.0|89.66|110.95|||||"Ratio of Geometric Least Squares Means (GLSM) was calculated as (GLSM of BI 730357 + omeprazole/GLSM of Omeprazole). Intra-individual geometric coefficient of variation (gCV \[%\]) =12.3."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||110.95|89.66|
73818863|NCT04679948|147185068|OTHER||Ratio of GLSMs [%]|71.32|||||TWO_SIDED|90.0|44.64|113.96|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + omeprazole/GLSM of Omeprazole). Intra-individual geometric coefficient of variation (gCV \[%\]) =87.8."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.96|44.64|
73818864|NCT04679948|147185069|OTHER||Ratio of GLSMs [%]|126.85|||||TWO_SIDED|90.0|119.15|135.05|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + midazolam/GLSM of Midazolam). Intra-individual geometric coefficient of variation (gCV \[%\]) =10.1."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||135.05|119.15|
73818865|NCT04679948|147185070|OTHER||Ratio of GLSMs [%]|130.25|||||TWO_SIDED|90.0|121.25|139.92|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + midazolam/GLSM of Midazolam). Intra-individual geometric coefficient of variation (gCV \[%\]) =11.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||139.92|121.25|
73818866|NCT01579669|147185074|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED||||||t-test, 2 sided|||Pre-post comparison||||0.0269
73818867|NCT01579669|147185075|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pre-post intervention comparison||||<0.0001
73818868|NCT01579669|147185076|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||Pre-post intervention comparison||||0.016
73818869|NCT00527124|147185077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907|STANDARD_ERROR_OF_MEAN|0.2973||0.7428|TWO_SIDED|95.0|0.506|1.624|||Regression, Cox|||||1.624|0.506|0.7428
73818870|NCT00527124|147185077|SUPERIORITY_OR_OTHER|||||||0.7425|TWO_SIDED|95.0|||||Log Rank|||||||0.7425
73818871|NCT01763203|147185096|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|||||||0.73
73818872|NCT01763203|147185097|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
73818873|NCT01763203|147185099|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
73818874|NCT01763203|147185100|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
73818875|NCT01763203|147185101|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.10
73818876|NCT01763203|147185102|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
73818877|NCT01763203|147185103|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||||||0.011
73818878|NCT01763203|147185104|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||||||0.47
73818879|NCT01763203|147185105|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||0.58
73818880|NCT01763203|147185106|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
73818881|NCT01763203|147185107|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||||||0.0021
73818882|NCT01763203|147185108|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
73818883|NCT01763203|147185109|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
73818884|NCT01763203|147185110|SUPERIORITY|||||||0.77|||||||Chi-squared|||||||0.77
73818885|NCT01763203|147185111|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
73818886|NCT01763203|147185112|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
73818887|NCT01763203|147185113|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
73818888|NCT01763203|147185114|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
73818889|NCT01763203|147185115|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
73818890|NCT02187861|147185116|SUPERIORITY_OR_OTHER||Difference in response rates|3.92|||||TWO_SIDED|95.0|-13.38|21.23||||||||21.23|-13.38|
73818891|NCT02187861|147185117|SUPERIORITY_OR_OTHER||Difference in response rates|1.96|||||TWO_SIDED|95.0|-15.89|19.81||||||||19.81|-15.89|
73818892|NCT02187861|147185118|SUPERIORITY_OR_OTHER||Difference in response rates|1.96|||||TWO_SIDED|95.0|-17.07|20.99||||||||20.99|-17.07|
73818893|NCT02187861|147185119|SUPERIORITY_OR_OTHER||Difference in response rates|-7.84|||||TWO_SIDED|95.0|-27.01|11.32||||||||11.32|-27.01|
73818894|NCT02187861|147185120|SUPERIORITY_OR_OTHER||Difference in response rates|13.73|||||TWO_SIDED|95.0|-4.24|31.69||||||At 6-8 weeks after Cycle 6 Day 1||31.69|-4.24|
73818895|NCT02187861|147185120|SUPERIORITY_OR_OTHER||Difference in response rates|3.92|||||TWO_SIDED|95.0|-12.98|20.82||||||At Year 1||20.82|-12.98|
73818896|NCT02187861|147185121|SUPERIORITY_OR_OTHER||Difference in response rates|-15.69|||||TWO_SIDED|95.0|-31.87|0.49||||||At 4-10 weeks after Cycle 6 Day 1||0.49|-31.87|
73818897|NCT02187861|147185121|SUPERIORITY_OR_OTHER||Difference in response rates|-7.84|||||TWO_SIDED|95.0|-22.56|6.87||||||At Year 1||6.87|-22.56|
73818898|NCT02187861|147185127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.27|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and DOR of prior cancer therapy.||1.27|0.38|
73818899|NCT02187861|147185127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.43|1.4|||||HR was calculated using Cox regression.|Unstratified Analysis||1.40|0.43|
73818900|NCT02187861|147185129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and PFS of prior cancer therapy.||1.24|0.38|
73818901|NCT02187861|147185129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis||1.36|0.43|
73818902|NCT02187861|147185131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and EFS of prior cancer therapy.||1.24|0.38|
73818903|NCT02187861|147185131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis||1.36|0.43|
73818904|NCT02187861|147185133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.04|5.37|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and OS of prior cancer therapy.||5.37|0.04|
73818905|NCT02187861|147185133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.63|||||HR was calculated using Cox regression.|Unstratified Analysis||5.63|0.05|
73818906|NCT01462305|147185244|SUPERIORITY_OR_OTHER|||||||0.74||||||interaction effect and week of treatment condition|ANOVA|||To test the hypothesis that depressed SAD patients would demonstrate greater antidepressant therapeutic benefit from the \~465nm (shorter wavelength) source compared with the \~595nm (longer wavelength) source, we conducted a repeated-measures ANOVA using PROC MIXED in SAS 9.3 with treatment (\~465nm vs. \~595nm) as a between-subject factor and time (treatment visit 1, treatment visit 2, treatment visit 3, phone assessment 1, phone assessment 2, and treatment visit 4) as a within-subject factor.||||0.74
73818907|NCT01462305|147185244|SUPERIORITY_OR_OTHER|||||||0.9||||||A repeated-measures ANOVA on the 29 subjects revealed no significant effect or interaction effect|ANOVA|||||||0.9
73818908|NCT01462305|147185244|SUPERIORITY_OR_OTHER||||||<|0.0001||||||A repeated-measures ANOVA on the 29 subjects revealed significant effect of treatment week|ANOVA|||||||<0.0001
73818909|NCT01462305|147185246|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||||||0.20
73818910|NCT00368459|147185252|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||For this pilot trial, we did not anticipate power to detect significant, clinically-meaningful between-group differences of the magnitude provided by FDA-approved AD therapies over a 12 month treatment period, but we specified that we would report trends (alpha \<0.1) as a guide to future effectiveness studies.||||>0.1
73818911|NCT00368459|147185253|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
73818912|NCT00368459|147185254|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
73818913|NCT00368459|147185255|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
73818914|NCT00368459|147185256|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
73818915|NCT00368459|147185257|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
73818916|NCT00368459|147185258|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
73818917|NCT00368459|147185259|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Favoring placebo, unadjusted for multiple comparisons|ANCOVA|||||||<0.01
73818918|NCT00368459|147185260|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
73818919|NCT00368459|147185261|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
73818920|NCT01461473|147185333|SUPERIORITY_OR_OTHER|||||||0.2067|||||||Analysis of covariance (GLM)|||These data were analyzed using an analysis of covariance via general linear model (GLM). The GLM has an indicator variable for PAP vs. OA plus covariates for baseline apnea-hypopnea index, gender, site and baseline NMAP. The primary hypothesis tested is that the 2-month means differ between study arms, after adjustment for the above covariates. A Wald statistic was constructed for hypothesis testing.||||0.2067
73818921|NCT01461473|147185334|SUPERIORITY_OR_OTHER|||||||0.3902|||||||GLMM|||Generalized linear mixed model (GLMM) was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.3902
73818922|NCT01461473|147185335|SUPERIORITY_OR_OTHER|||||||0.9319|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.9319
73818923|NCT01461473|147185336|SUPERIORITY_OR_OTHER|||||||0.3895|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.3895
73896515|NCT00913458|147326254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.01||||0.4664|TWO_SIDED|95.0|-15.0|6.9|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||6.9|-15.0|0.4664
73896516|NCT00913458|147326254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.57||||0.021|TWO_SIDED|95.0|-30.6|-2.6|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-2.6|-30.6|0.0210
73818924|NCT01461473|147185337|SUPERIORITY_OR_OTHER|||||||0.3449|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.||||0.3449
73818925|NCT01461473|147185338|SUPERIORITY_OR_OTHER|||||||0.1531|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.||||0.1531
73818926|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818927|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818928|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818929|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818930|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818931|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818932|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818933|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818934|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818935|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818936|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818937|NCT00524680|147185382|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
73818938|NCT00524680|147185383|SUPERIORITY_OR_OTHER|||||||0.8244|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 4000 IU. Statistical analysis was done using one sample t-test.||||0.8244
73818939|NCT00524680|147185383|SUPERIORITY_OR_OTHER|||||||0.1025|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 4000 IU. Statistical analysis was done using one sample t-test.||||0.1025
73818940|NCT00524680|147185383|SUPERIORITY_OR_OTHER|||||||0.1744|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-Month for dose level 4000 IU.||||0.1744
73818941|NCT00524680|147185383|SUPERIORITY_OR_OTHER|||||||0.1281|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 6000 IU. Statistical analysis was done using one sample t-test.||||0.1281
73818942|NCT00524680|147185383|SUPERIORITY_OR_OTHER|||||||0.9688|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 6000 IU. Statistical analysis was done using one sample t-test.||||0.9688
73818943|NCT00524680|147185383|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 6000 IU. Statistical analysis was done using one sample t-test.||||<0.0001
73818944|NCT00524680|147185383|SUPERIORITY_OR_OTHER|||||||0.8241|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.8241
73818945|NCT00524680|147185383|SUPERIORITY_OR_OTHER|||||||0.1828|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.1828
73818946|NCT00524680|147185383|SUPERIORITY_OR_OTHER|||||||0.1348|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.1348
73818947|NCT00524680|147185383|SUPERIORITY_OR_OTHER|||||||0.2214|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.2214
73818948|NCT00524680|147185383|SUPERIORITY_OR_OTHER|||||||0.0079|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.0079
73818949|NCT00524680|147185383|SUPERIORITY_OR_OTHER|||||||0.0631|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.0631
73818950|NCT03124537|147185386|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health||Tested whether weekly steps increased from the baseline week in both conditions (main effect of time).||||< .001
73818951|NCT03124537|147185386|SUPERIORITY|||||||0.846||||||Controlling for age, sex, education, and health.|Mixed Models Analysis|||Tested whether weekly step increases from the baseline week differed between the two conditions (time by condition interaction).||||.846
73818952|NCT03124537|147185387|SUPERIORITY|||||||0.571||||||Controlling for age, sex, condition, education, and health.|Mixed Models Analysis|||Tested whether exercise self-efficacy increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.571
73818953|NCT03124537|147185387|SUPERIORITY|||||||0.361|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether exercise self efficacy increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.361
73818954|NCT03124537|147185388|SUPERIORITY|||||||0.564|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether exercise control increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.564
73818955|NCT03124537|147185388|SUPERIORITY|||||||0.641|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether exercise control belief increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.641
73818956|NCT03124537|147185390|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, health, and average steps.||Tested whether daily walking was related to mood within-persons.||||< .001
73818957|NCT03124537|147185390|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|Controlling for age, condition, education, health, and average steps.||Tested whether daily walking was related to energy within-persons.||||.003
73818958|NCT03124537|147185390|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, health, and average steps.||Tested whether the relationship between daily walking and mood differed between males and females (steps by sex interaction).||||< .001
73818959|NCT03124537|147185390|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, condition, education, health, and average steps.||Tested whether the relationship between daily walking and energy differed between males and females (steps by sex interaction).||||< .001
73818960|NCT03124537|147185391|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported vigorous physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.011
73818961|NCT03124537|147185391|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported vigorous physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.232
73818962|NCT03124537|147185392|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported moderate physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.530
73818963|NCT03124537|147185392|SUPERIORITY|||||||0.831|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported moderate physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.831
73818964|NCT03124537|147185393|SUPERIORITY|||||||0.199|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported light physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.199
73818965|NCT03124537|147185393|SUPERIORITY|||||||0.203|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported light physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.203
73818966|NCT03681184|147185394|SUPERIORITY||Difference in Least Squares (LS) Mean|-53.546|STANDARD_ERROR_OF_MEAN|4.3224|<|0.0001|TWO_SIDED|95.0|-62.314|-44.778||P=1.685E-14|MMRM|||The Mixed-Effect Model Repeated Measures (MMRM) includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate corrected for BSA as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-44.778|-62.314|<0.0001
73818967|NCT03681184|147185395|SUPERIORITY||Difference in LS Mean|-0.975|STANDARD_ERROR_OF_MEAN|0.0998|<|0.0001|TWO_SIDED|95.0|-1.177|-0.772||P=1.225E-11|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate corrected for BSA as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-0.772|-1.177|<0.0001
73818968|NCT03681184|147185396|SUPERIORITY||Difference in LS Mean|-51.7718|STANDARD_ERROR_OF_MEAN|6.16118|<|0.0001|TWO_SIDED|95.0|-64.2653|-39.2784||P=5.032E-10|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate:creatinine ratio as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-39.2784|-64.2653|<0.0001
73818969|NCT03681184|147185397|SUPERIORITY||Difference in Proportions|0.84|||<|0.0001|TWO_SIDED|95.0|0.55|0.94||P=8.341E-07|Cochran-Mantel-Haenszel|||The proportion of participants (lumasiran vs. placebo) with 24-hour urinary oxalate ≤1.5 x ULN at Month 6 is analyzed using the Cochran-Mantel-Haenszel test, stratified by baseline 24-hour urinary oxalate corrected for BSA (≤1.70 mmol/24hr/1.73m\^2 vs. \>1.70 mmol/24hr/1.73m\^2). The difference in proportion (lumasiran vs. placebo) and the corresponding 95% confidence interval are calculated using the Newcombe method, based on the Wilson score.||0.94|0.55|<0.0001
73818970|NCT03681184|147185398|SUPERIORITY||Difference in Proportions|0.52||||0.001|TWO_SIDED|95.0|0.23|0.7|||Cochran-Mantel-Haenszel|||The proportion of participants (lumasiran vs. placebo) with 24-hour urinary oxalate ≤ULN at Month 6 is analyzed using the Cochran-Mantel-Haenszel test, stratified by baseline 24-hour urinary oxalate corrected for BSA (≤1.70 mmol/24hr/1.73m\^2 vs. \>1.70 mmol/24hr/1.73m\^2). The difference in proportion (lumasiran vs. placebo) and the corresponding 95% confidence interval are calculated using the Newcombe method, based on the Wilson score.||0.70|0.23|0.0010
73818971|NCT03681184|147185399|SUPERIORITY||Difference in LS Mean|-39.48|STANDARD_ERROR_OF_MEAN|5.181|<|0.0001|TWO_SIDED|95.0|-50.1|-28.87||P=2.862E-08|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline plasma oxalate as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-28.87|-50.10|<0.0001
73818972|NCT03681184|147185400|SUPERIORITY||Difference in LS Mean|-8.71|STANDARD_ERROR_OF_MEAN|1.338|<|0.0001|TWO_SIDED|95.0|-11.45|-5.98||P=3.893E-07|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline plasma oxalate as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-5.98|-11.45|<0.0001
73818973|NCT04424914|147185452|OTHER|||||||0.3006|||||||Chi-squared|p-values for comparison of proportions of CLASS I+II vs CLASS III+IV were based on a Chi-square test.||||||0.3006
73818974|NCT04424914|147185453|OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
73818975|NCT04485637|147185454|SUPERIORITY||Odds Ratio (OR)|1.67|||=|0.05|TWO_SIDED|95.0|1.0|2.79|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced table \> Basic table||2.79|1.00|=0.05
73818976|NCT04485637|147185454|SUPERIORITY||Odds Ratio (OR)|1.66|||=|0.05|TWO_SIDED|95.0|1.0|2.76|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced graph \> Basic table||2.76|1.00|=0.05
73818977|NCT04485637|147185455|SUPERIORITY|Enhanced table \> Basic table|Odds Ratio (OR)|1.52|||=|0.29|TWO_SIDED|95.0|0.71|3.26|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||||3.26|0.71|=0.29
73818978|NCT04485637|147185455|SUPERIORITY|Enhanced graph \> Basic table|Odds Ratio (OR)|0.96|||=|0.9|TWO_SIDED|95.0|0.48|1.93|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||||1.93|0.48|=0.90
73818979|NCT04485637|147185456|SUPERIORITY||Unst|-0.14|||=|0.13|TWO_SIDED|95.0|-0.32|0.04|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced table \> Basic table||0.04|-0.32|=0.13
73818980|NCT04485637|147185456|SUPERIORITY||Unstandardized B|-0.14|||=|0.12|TWO_SIDED|95.0|-0.32|0.04|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced graph \> Basic table||0.04|-0.32|=0.12
73818981|NCT04485637|147185457|SUPERIORITY|Enhanced table \> Basic table|Unstandardized B|-0.08|||=|0.33|TWO_SIDED|95.0|-0.25|0.08|||Regression, Linear|||||0.08|-0.25|=0.33
73818982|NCT04485637|147185457|SUPERIORITY||Unstandardized B|-0.09|||=|0.29|TWO_SIDED|95.0|-0.26|0.08|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||||0.08|-0.26|=0.29
73818983|NCT01778751|147185460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.012|TWO_SIDED|95.0|-1.7|-0.2|||Mixed Models Analysis|||Comparison at 3 months||-0.2|-1.7|0.012
73818984|NCT01778751|147185460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.05|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||Comparison at 6 months||-0.0|-2.0|0.050
73818985|NCT01778751|147185461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.303|TWO_SIDED|95.0|-2.7|8.4|||Mixed Models Analysis|||Comparison at 3 months, Scale is 0-100 where a higher score is a better outcome.||8.4|-2.7|0.303
73818986|NCT01778751|147185461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.7||||0.027|TWO_SIDED|95.0|0.9|14.4|||Mixed Models Analysis|||Comparison at 6 months, Scale is 0-100 where a higher score is a better outcome.||14.4|0.9|0.027
73818987|NCT01778751|147185462|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.83|TWO_SIDED|95.0|0.35|2.34|||Generalized estimating equation (GEE)|||||2.34|0.35|0.830
73818988|NCT01778751|147185462|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.97|TWO_SIDED|95.0|0.33|3.19|||Generalized Estimating Equation (GEE)|||Comparison at 6 months||3.19|0.33|0.970
73818989|NCT01778751|147185463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.428|TWO_SIDED|95.0|-3.3|1.4|||Mixed Models Analysis|||Comparison at 3 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.||1.4|-3.3|0.428
73818990|NCT01778751|147185463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1||||0.397|TWO_SIDED|95.0|-1.4|3.6|||Mixed Models Analysis|||Comparison at 6 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.||3.6|-1.4|0.397
73818991|NCT01454414|147185465|SUPERIORITY_OR_OTHER_LEGACY||Protective effectiveness= 1 - rate ratio|0.646||||0.004|TWO_SIDED|95.0|0.288|0.824|||Poisson regression|||Protective effectiveness (1 - the incidence rate ratio) and 95% CIs for comparing reported tick bites between the treatment and control groups were calculated using a GEE model with a Poisson distribution and log link, and included terms for treatment, year of follow-up, and the interaction of treatment and year of follow-up, with an offset variable for log outdoor work hours.||0.824|0.288|0.004
73818992|NCT03078127|147185472|SUPERIORITY|||||||0.615||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for statistical significance was set to 0.05|ANOVA|||No comparable preliminary data exists on mucociliary clearance (MCC) in response to airway clearance therapy methods (ACTs) for a power calculation. However, prior studies of medication effect on MCC gave a baseline mean change of Ave270 clr of 27.7% (std dev of 15.1%). Thus, the investigators estimated a mean change of 20% for effective ACT with the same estimate for variability (Std Dev of 15.1%). Using a paired 2-tailed test to compare means, 7 subjects were estimated to be needed.||||0.615
73818993|NCT03078127|147185473|SUPERIORITY|||||||0.696||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for significance was \< 0.05.|ANOVA|||||||0.696
73818994|NCT03078127|147185475|SUPERIORITY|||||||0.001||||||The a priori threshold of statistical significance was p = 0.05|t-test, 2 sided|||The investigators compared FENO before and after ACT in a pooled manner (i.e., grouping each of the comparisons together), as the study was not powered for FENO comparisons within each ACT type.||||0.001
73818995|NCT03078127|147185475|OTHER|A linear regression was performed between change in FENO and Ave90Clr||||||0.692||||||The a priori threshold for statistical significance (i.e., slope different than zero) between MCC and FENO was 0.05|Regression, Linear|||if the difference between pre and post-ACT FENO was significant (defined as p\<0.05), it was investigated whether change in FENO correlated with MCC (as represented by Ave90Clr)||||0.692
73818996|NCT03078127|147185476|SUPERIORITY|||||||0.146||||||Non-parametric test used due to lack of data normality. The a prior threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.146
73818997|NCT03078127|147185477|SUPERIORITY|||||||0.041||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.041
73818998|NCT03078127|147185477|OTHER|A linear regression was performed between change in pre and post-ACT adenosine (purine) in EBC and Ave90Clr||||||0.047||||||The a priori threshold of statistical significance was p = 0.05|Regression, Linear|||If the difference between pre and post-ACT adenosine (purine) in EBC was significant (defined as p\<0.05), the correlation between change in adenosine concentration and MCC (as represented by Ave90Clr) was investigated.||||0.047
73818999|NCT03078127|147185478|SUPERIORITY|||||||0.07||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.070
73819000|NCT02685072|147185479|SUPERIORITY||Odds Ratio (OR)|0.5818||||0.3253|TWO_SIDED|95.0|0.1968|1.7202|||Chi-squared|degrees of freedom =1|Odds ratio represents odds of smoking abstinence in TPN + progesterone group versus TPN + placebo group|||1.7202|0.1968|0.3253
73819001|NCT02685072|147185480|SUPERIORITY||Odds Ratio (OR)|1.0781||||0.8944|TWO_SIDED|95.0|0.355|3.2744|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 (negative for smoking) in TPN + progesterone versus TPN + placebo groups|||3.2744|0.3550|0.8944
73819002|NCT02685072|147185481|SUPERIORITY||Odds Ratio (OR)|0.7619||||0.662|TWO_SIDED|95.0|0.2247|2.5838|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.5838|0.2247|0.6620
73819003|NCT02685072|147185482|SUPERIORITY||Odds Ratio (OR)|0.913||||0.8661|TWO_SIDED|95.0|0.3171|2.6287|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.6287|0.3171|0.8661
73819004|NCT02685072|147185483|SUPERIORITY||Mean Difference (Final Values)|-9.1|STANDARD_DEVIATION|31.7||0.31|TWO_SIDED|95.0|-27.1|9.0|||t-test, 2 sided||(Placebo + TPN) - (Progesterone + TPN)|||9.0|-27.1|0.31
73819005|NCT02685072|147185484|SUPERIORITY||Mean Difference (Final Values)|0.148||||0.791|TWO_SIDED|95.0|-0.9747|1.2707|||t-test, 2 sided||(placebo + TPN) - (progesterone + TPN)|||1.2707|-0.9747|0.7910
73819006|NCT02685072|147185485|SUPERIORITY||Mean Difference (Final Values)|9.26||||0.0065|TWO_SIDED|95.0|2.71|15.81|||t-test, 2 sided|||||15.81|2.71|0.0065
73819007|NCT02685072|147185496|SUPERIORITY||Odds Ratio (OR)|0.7172||||0.6449|TWO_SIDED|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.9594|0.1738|.6449
73819008|NCT02685072|147185497|SUPERIORITY||Odds Ratio (OR)|0.7172||||0.6449|TWO_SIDED|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of prolonged abstinence in TPN + progesterone versus TPN + placebo.|||2.9594|0.1738|0.6449
73819009|NCT02432144|147185508|SUPERIORITY||LS Mean|-62.28|STANDARD_ERROR_OF_MEAN|4.946|<|0.0001|TWO_SIDED|95.0|-71.98|-52.59||P-values are from generalized estimating equation (GEE) model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 0||-52.59|-71.98|< 0.0001
73819010|NCT02432144|147185508|SUPERIORITY||LS Mean|-67.18|STANDARD_ERROR_OF_MEAN|3.224|<|0.0001|TWO_SIDED|95.0|-73.49|-60.86||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 12||-60.86|-73.49|< 0.0001
73819011|NCT02432144|147185508|SUPERIORITY||LS Mean|-64.12|STANDARD_ERROR_OF_MEAN|4.016|<|0.0001|TWO_SIDED|95.0|-71.99|-56.24||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 24||-56.24|-71.99|< 0.0001
73819012|NCT02432144|147185508|SUPERIORITY||LS Mean|-60.8|STANDARD_ERROR_OF_MEAN|5.992|<|0.0001|TWO_SIDED|95.0|-72.54|-49.06||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 36||-49.06|-72.54|< 0.0001
73819013|NCT02432144|147185508|SUPERIORITY||LS Mean|-57.85|||<|0.0001|TWO_SIDED|95.0|-71.87|-43.82||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 48||-43.82|-71.87|< 0.0001
73819014|NCT01451554|147185509|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||2 tailed t-test|t-test, 2 sided|||Data were compared between groups using the 2 sample T-test.||||0.06
73819015|NCT01451554|147185510|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||Data were compared between groups using a 2 sample T-test.||||0.31
73819016|NCT01402986|147185511|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.709|TWO_SIDED|95.0|0.67|1.31|||Poisson regression|||The 95 percent (%) confidence interval (CI) for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 versus \[vs\] more than \[\>\] 2 but less than or equal to \[=\<\] 6), atopic asthma status (atopic/non-atopic), chronic oral corticosteroid (OCS) use (presence vs absence) and geographical region as the covariates.||1.31|0.67|0.709
73819017|NCT01402986|147185511|SUPERIORITY_OR_OTHER||Rate Ratio|1.02||||0.904|TWO_SIDED|95.0|0.71|1.46|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \> 2 but =\< 6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.46|0.71|0.904
73819018|NCT01402986|147185528|SUPERIORITY_OR_OTHER||Rate Ratio|0.62||||0.293|TWO_SIDED|95.0|0.26|1.51|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.51|0.26|0.293
73819019|NCT01402986|147185528|SUPERIORITY_OR_OTHER||Rate Ratio|0.62||||0.27|TWO_SIDED|95.0|0.27|1.44|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.44|0.27|0.270
73819020|NCT01402986|147185529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.257|TWO_SIDED|95.0|0.57|1.16|||Regression, Cox|||||1.16|0.57|0.257
73819021|NCT01402986|147185529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.225|TWO_SIDED|95.0|0.56|1.15|||Regression, Cox|||||1.15|0.56|0.225
73819022|NCT01402986|147185530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.538|TWO_SIDED|95.0|0.37|1.68|||Regression, Cox|||||1.68|0.37|0.538
73819023|NCT01402986|147185530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.561|TWO_SIDED|95.0|0.37|1.71|||Regression, Cox|||||1.71|0.37|0.561
73819024|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|0.73||||0.19|TWO_SIDED|95.0|0.46|1.17|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= median||1.17|0.46|0.190
73819025|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.856|TWO_SIDED|95.0|0.56|1.61|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= median||1.61|0.56|0.856
73819026|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|1.13||||0.602|TWO_SIDED|95.0|0.71|1.81|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< median||1.81|0.71|0.602
73819027|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.703|TWO_SIDED|95.0|0.55|1.5|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< median||1.50|0.55|0.703
73819028|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|0.86||||0.455|TWO_SIDED|95.0|0.58|1.28|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 25th Percentile||1.28|0.58|0.455
73819029|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|1.02||||0.929|TWO_SIDED|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 25th Percentile||1.57|0.66|0.929
73819030|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|1.26||||0.507|TWO_SIDED|95.0|0.63|2.51|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 25th Percentile||2.51|0.63|0.507
73819031|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.805|TWO_SIDED|95.0|0.44|1.89|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 25th Percentile||1.89|0.44|0.805
73819032|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|0.88||||0.716|TWO_SIDED|95.0|0.44|1.75|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 75th Percentile||1.75|0.44|0.716
73819033|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|1.51||||0.328|TWO_SIDED|95.0|0.66|3.43|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 75th Percentile||3.43|0.66|0.328
73819034|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.804|TWO_SIDED|95.0|0.64|1.41|||Poission regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 75th Percentile||1.41|0.64|0.804
73819035|NCT01402986|147185531|SUPERIORITY_OR_OTHER||Rate Ratio|0.7||||0.088|TWO_SIDED|95.0|0.47|1.05|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 75th Percentile||1.05|0.47|0.088
73819036|NCT01402986|147185532|SUPERIORITY_OR_OTHER||Rate Ratio|0.8||||0.365|TWO_SIDED|95.0|0.5|1.29|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.29|0.50|0.365
73819037|NCT01402986|147185532|SUPERIORITY_OR_OTHER||Rate Ratio|0.97||||0.922|TWO_SIDED|95.0|0.56|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.68|0.56|0.922
73819038|NCT01402986|147185532|SUPERIORITY_OR_OTHER||Rate Ratio|1.11||||0.685|TWO_SIDED|95.0|0.67|1.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.84|0.67|0.685
73819039|NCT01402986|147185532|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.813|TWO_SIDED|95.0|0.66|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.70|0.66|0.813
73819040|NCT01402986|147185533|SUPERIORITY_OR_OTHER||Rate Ratio|0.82||||0.335|TWO_SIDED|95.0|0.56|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=150 cells/mcgL||1.22|0.56|0.335
73819041|NCT01402986|147185533|SUPERIORITY_OR_OTHER||Rate Ratio|0.88||||0.586|TWO_SIDED|95.0|0.54|1.41|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=150 cells/mcgL||1.41|0.54|0.586
73819042|NCT01402986|147185533|SUPERIORITY_OR_OTHER||Rate Ratio|1.36||||0.331|TWO_SIDED|95.0|0.73|2.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<150 cells/mcgL||2.52|0.73|0.331
73819043|NCT01402986|147185533|SUPERIORITY_OR_OTHER||Rate Ratio|1.41||||0.311|TWO_SIDED|95.0|0.73|2.71|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<150 cells/mcgL||2.71|0.73|0.311
73819044|NCT01402986|147185533|SUPERIORITY_OR_OTHER||Rate Ratio|0.81||||0.414|TWO_SIDED|95.0|0.48|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.35|0.48|0.414
73819045|NCT01402986|147185533|SUPERIORITY_OR_OTHER||Rate Ratio|1.26||||0.463|TWO_SIDED|95.0|0.68|2.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||2.36|0.68|0.463
73819046|NCT01402986|147185533|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.793|TWO_SIDED|95.0|0.67|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||1.68|0.67|0.793
73819047|NCT01402986|147185533|SUPERIORITY_OR_OTHER||Rate Ratio|0.77||||0.264|TWO_SIDED|95.0|0.49|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||1.22|0.49|0.264
73819048|NCT01402986|147185534|SUPERIORITY_OR_OTHER||Rate Ratio|0.66||||0.245|TWO_SIDED|95.0|0.33|1.32|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||1.32|0.33|0.245
73819049|NCT01402986|147185534|SUPERIORITY_OR_OTHER||Rate Ratio|0.76||||0.438|TWO_SIDED|95.0|0.37|1.54|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||1.54|0.37|0.438
73819050|NCT01402986|147185534|SUPERIORITY_OR_OTHER||Rate Ratio|1.01||||0.947|TWO_SIDED|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.57|0.66|0.947
73819051|NCT01402986|147185534|SUPERIORITY_OR_OTHER||Rate Ratio|0.97||||0.916|TWO_SIDED|95.0|0.59|1.59|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.59|0.59|0.916
73819052|NCT01402986|147185535|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.723|TWO_SIDED|95.0|0.52|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=60%||1.56|0.52|0.723
73819053|NCT01402986|147185535|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.852|TWO_SIDED|95.0|0.6|1.86|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=60%||1.86|0.60|0.852
73819054|NCT01402986|147185535|SUPERIORITY_OR_OTHER||Rate Ratio|0.86||||0.409|TWO_SIDED|95.0|0.6|1.23|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=80%||1.23|0.60|0.409
73819055|NCT01402986|147185535|SUPERIORITY_OR_OTHER||Rate Ratio|1.07||||0.744|TWO_SIDED|95.0|0.72|1.58|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=80%||1.58|0.72|0.744
73819056|NCT01402986|147185536|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.802|TWO_SIDED|95.0|0.58|1.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year||1.52|0.58|0.802
73819057|NCT01402986|147185536|SUPERIORITY_OR_OTHER||Rate Ratio|0.6||||0.05|TWO_SIDED|95.0|0.36|1.0|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year||1.00|0.36|0.050
73819058|NCT01402986|147185536|SUPERIORITY_OR_OTHER||Rate Ratio|0.93||||0.792|TWO_SIDED|95.0|0.56|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|\> 2 but \< 6 asthma exacerbations in the past year||1.56|0.56|0.792
73819059|NCT01402986|147185536|SUPERIORITY_OR_OTHER||Rate Ratio|1.39||||0.231|TWO_SIDED|95.0|0.81|2.38|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|\> 2 but \< 6 asthma exacerbations in the past year||2.38|0.81|0.231
73819060|NCT01402986|147185537|SUPERIORITY_OR_OTHER||Rate Ratio|0.25||||0.046|TWO_SIDED|95.0|0.06|0.98|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \>=Median||0.98|0.06|0.046
73819061|NCT01402986|147185537|SUPERIORITY_OR_OTHER||Rate Ratio|0.47||||0.197|TWO_SIDED|95.0|0.15|1.48|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \>=Median||1.48|0.15|0.197
73819062|NCT01402986|147185537|SUPERIORITY_OR_OTHER||Rate Ratio|1.18||||0.708|TWO_SIDED|95.0|0.5|2.79|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \< Median||2.79|0.50|0.708
73819063|NCT01402986|147185537|SUPERIORITY_OR_OTHER||Rate Ratio|1.31||||0.594|TWO_SIDED|95.0|0.48|3.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \< Median||3.57|0.48|0.594
73819064|NCT01402986|147185538|SUPERIORITY_OR_OTHER||Rate Ratio|1.03||||0.975|TWO_SIDED|95.0|0.14|7.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||7.67|0.14|0.975
73819065|NCT01402986|147185538|SUPERIORITY_OR_OTHER||Rate Ratio|1.66||||0.473|TWO_SIDED|95.0|0.41|6.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||6.67|0.41|0.473
73819066|NCT01402986|147185538|SUPERIORITY_OR_OTHER||Rate Ratio|0.49||||0.099|TWO_SIDED|95.0|0.21|1.14|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.14|0.21|0.099
73819067|NCT01402986|147185538|SUPERIORITY_OR_OTHER||Rate Ratio|0.42||||0.148|TWO_SIDED|95.0|0.13|1.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.36|0.13|0.148
73819068|NCT01402986|147185539|SUPERIORITY_OR_OTHER||Rate Ratio|0.82||||0.698|TWO_SIDED|95.0|0.31|2.19|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||2.19|0.31|0.698
73819069|NCT01402986|147185539|SUPERIORITY_OR_OTHER||Rate Ratio|0.55||||0.299|TWO_SIDED|95.0|0.18|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.70|0.18|0.299
73819070|NCT01402986|147185539|SUPERIORITY_OR_OTHER||Rate Ratio|0.25||||0.105|TWO_SIDED|95.0|0.05|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.34|0.05|0.105
73819071|NCT01402986|147185539|SUPERIORITY_OR_OTHER||Rate Ratio|0.7||||0.576|TWO_SIDED|95.0|0.2|2.47|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||2.47|0.20|0.576
73819072|NCT01402986|147185540|SUPERIORITY_OR_OTHER||Rate Ratio|0.48||||0.133|TWO_SIDED|95.0|0.19|1.25|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.25|0.19|0.133
73819073|NCT01402986|147185540|SUPERIORITY_OR_OTHER||Rate Ratio|0.46||||0.241|TWO_SIDED|95.0|0.13|1.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.67|0.13|0.241
73819074|NCT01402986|147185540|SUPERIORITY_OR_OTHER||Rate Ratio|0.59||||0.51|TWO_SIDED|95.0|0.12|2.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||2.84|0.12|0.510
73819075|NCT01402986|147185540|SUPERIORITY_OR_OTHER||Rate Ratio|0.74||||0.661|TWO_SIDED|95.0|0.19|2.85|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||2.85|0.19|0.661
73819076|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.79||||0.057|TWO_SIDED|95.0|-0.21|13.79|||Repeated measure model|||Baseline serum periostin \>= median||13.79|-0.21|0.057
73819077|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.57||||0.874|TWO_SIDED|95.0|-6.54|7.68|||Repeated measure model|||Baseline serum periostin \>= median||7.68|-6.54|0.874
73819078|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.37||||0.028|TWO_SIDED|95.0|0.8|13.95|||Repeated measure model|||Baseline serum periostin \< median||13.95|0.80|0.028
73819079|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.09||||0.745|TWO_SIDED|95.0|-5.48|7.66|||Repeated measure model|||Baseline serum periostin \< median||7.66|-5.48|0.745
73819080|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.12||||0.011|TWO_SIDED|95.0|1.66|12.58|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||12.58|1.66|0.011
73819081|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.48||||0.863|TWO_SIDED|95.0|-5.93|4.97|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||4.97|-5.93|0.863
73819082|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.24||||0.221|TWO_SIDED|95.0|-3.8|16.27|||Repeated measure model|||Baseline serum periostin \< 25th percentile||16.27|-3.80|0.221
73819083|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.58||||0.108|TWO_SIDED|95.0|-1.91|19.07|||Repeated measure model|||Baseline serum periostin \< 25th percentile||19.07|-1.91|0.108
73819084|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|9.89||||0.09|TWO_SIDED|95.0|-1.57|21.35|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||21.35|-1.57|0.090
73819085|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.7||||0.908|TWO_SIDED|95.0|-11.19|12.59|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||12.59|-11.19|0.908
73819086|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.52||||0.013|TWO_SIDED|95.0|1.41|11.64|||Repeated measure model|||Baseline serum periostin \< 75th percentile||11.64|1.41|0.013
73819087|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.23||||0.635|TWO_SIDED|95.0|-3.84|6.29|||Repeated measure model|||Baseline serum periostin \< 75th percentile||6.29|-3.84|0.635
73819088|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.89||||0.014|TWO_SIDED|95.0|1.84|15.94|||Repeated measure model|||Th2 high||15.94|1.84|0.014
73819089|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|3.91||||0.28|TWO_SIDED|95.0|-3.19|11.02|||Repeated measure model|||Th2 high||11.02|-3.19|0.280
73819090|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|3.22||||0.292|TWO_SIDED|95.0|-2.78|9.22|||Repeated measure model|||Th2 low||9.22|-2.78|0.292
73819091|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|-1.18||||0.691|TWO_SIDED|95.0|-6.99|4.64|||Repeated measure model|||Th2 low||4.64|-6.99|0.691
73819092|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.83||||0.004|TWO_SIDED|95.0|2.85|14.81|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||14.81|2.85|0.004
73819093|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|4.25||||0.177|TWO_SIDED|95.0|-1.92|10.43|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||10.43|-1.92|0.177
73819094|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.05||||0.159|TWO_SIDED|95.0|-2.39|14.5|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||14.50|-2.39|0.159
73819095|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.72||||0.857|TWO_SIDED|95.0|-8.63|7.18|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||7.18|-8.63|0.857
73819096|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|13.75||||0.002|TWO_SIDED|95.0|5.28|22.22|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||22.22|5.28|0.002
73819097|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|5.23||||0.243|TWO_SIDED|95.0|-3.56|14.02|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||14.02|-3.56|0.243
73819098|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|4.37||||0.144|TWO_SIDED|95.0|-1.5|10.24|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||10.24|-1.50|0.144
73819099|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.72||||0.804|TWO_SIDED|95.0|-5.01|6.46|||Baseline peripheral blood eosinophil cou|||Baseline peripheral blood eosinophil count \< 300 cells/μ||6.46|-5.01|0.804
73819100|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|11.19||||0.029|TWO_SIDED|95.0|1.15|21.23|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||21.23|1.15|0.029
73819101|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.72||||0.887|TWO_SIDED|95.0|-9.19|10.62|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||10.62|-9.19|0.887
73819102|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.67||||0.002|TWO_SIDED|95.0|2.76|12.59|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||12.59|2.76|0.002
73819103|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|2.79||||0.268|TWO_SIDED|95.0|-2.15|7.74|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||7.74|-2.15|0.268
73819104|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.82||||0.003|TWO_SIDED|95.0|2.64|13.01|||Repeated measure model|||2 asthma exacerbations in the past year||13.01|2.64|0.003
73819105|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|2.42||||0.361|TWO_SIDED|95.0|-2.78|7.62|||Repeated measure model|||2 asthma exacerbations in the past year||7.62|-2.78|0.361
73819106|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.34||||0.185|TWO_SIDED|95.0|-3.06|15.75|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||15.75|-3.06|0.185
73819107|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.08||||0.986|TWO_SIDED|95.0|-9.5|9.34|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||9.34|-9.50|0.986
73819108|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.87||||0.912|TWO_SIDED|95.0|-14.7|16.44|||Repeated measure model|||Chronic OCS use||16.44|-14.70|0.912
73819109|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|-1.46||||0.86|TWO_SIDED|95.0|-17.76|14.84|||Repeated measure model|||Chronic OCS use||14.84|-17.76|0.860
73819110|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.56||||0.002|TWO_SIDED|95.0|2.76|12.36|||Repeated measure model|||Without chronic OCS use||12.36|2.76|0.002
73819111|NCT01402986|147185541|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.28||||0.601|TWO_SIDED|95.0|-3.51|6.06|||Repeated measure model|||Without chronic OCS use||6.06|-3.51|0.601
73819112|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.24||||0.145|TWO_SIDED|95.0|-0.57|0.08|||Repeated measure model|||Baseline serum periostin \>= median||0.08|-0.57|0.145
73819113|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.05||||0.759|TWO_SIDED|95.0|-0.28|0.38|||Repeated measure model|||Baseline serum periostin \>= median||0.38|-0.28|0.759
73819114|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.936|TWO_SIDED|95.0|-0.38|0.35|||Repeated measure model|||Baseline serum periostin \< median||0.35|-0.38|0.936
73819115|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.28||||0.127|TWO_SIDED|95.0|-0.64|0.08|||Repeated measure model|||Baseline serum periostin \< median||0.08|-0.64|0.127
73819116|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.13||||0.343|TWO_SIDED|95.0|-0.41|0.14|||Repeated measure model|||Baseline serum periostin\>= 25th percentile||0.14|-0.41|0.343
73819117|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.928|TWO_SIDED|95.0|-0.29|0.27|||Repeated measure model|||Baseline serum periostin\>= 25th percentile||0.27|-0.29|0.928
73819118|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.23||||0.374|TWO_SIDED|95.0|-0.74|0.28|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.28|-0.74|0.374
73819119|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.29||||0.259|TWO_SIDED|95.0|-0.81|0.22|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.22|-0.81|0.259
73819120|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.127|TWO_SIDED|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||0.11|-0.84|0.127
73819121|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.775|TWO_SIDED|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||0.42|-0.56|0.775
73819122|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.1||||0.512|TWO_SIDED|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.19|-0.38|0.512
73819123|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.404|TWO_SIDED|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.16|-0.40|0.404
73819124|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.24||||0.181|TWO_SIDED|95.0|-0.59|0.11|||Repeated measure model|||Th2 high||0.11|-0.59|0.181
73819125|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.25||||0.161|TWO_SIDED|95.0|-0.6|0.1|||Repeated measure model|||Th2 high||0.10|-0.60|0.161
73819126|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.11||||0.54|TWO_SIDED|95.0|-0.47|0.25|||Repeated measure model|||Th2 low||0.25|-0.47|0.540
73819127|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.674|TWO_SIDED|95.0|-0.42|0.27|||Repeated measure model|||Th2 low||0.27|-0.42|0.674
73819128|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.22||||0.154|TWO_SIDED|95.0|-0.52|0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||0.08|-0.52|0.154
73819129|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.17||||0.271|TWO_SIDED|95.0|-0.48|0.13|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μ||0.13|-0.48|0.271
73819130|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.08||||0.725|TWO_SIDED|95.0|-0.51|0.36|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.36|-0.51|0.725
73819131|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.559|TWO_SIDED|95.0|-0.53|0.28|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.28|-0.53|0.559
73819132|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.47||||0.019|TWO_SIDED|95.0|-0.87|-0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||-0.08|-0.87|0.019
73819133|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.2||||0.348|TWO_SIDED|95.0|-0.61|0.21|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.21|-0.61|0.348
73819134|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.03||||0.855|TWO_SIDED|95.0|-0.35|0.29|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.29|-0.35|0.855
73819135|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.2||||0.203|TWO_SIDED|95.0|-0.5|0.11|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.11|-0.50|0.203
73819136|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.44||||0.055|TWO_SIDED|95.0|-0.89|0.01|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.01|-0.89|0.055
73819137|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.104|TWO_SIDED|95.0|-0.82|0.08|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.08|-0.82|0.104
73819138|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.652|TWO_SIDED|95.0|-0.37|0.23|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.23|-0.37|0.652
73819139|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.02||||0.905|TWO_SIDED|95.0|-0.28|0.32|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.32|-0.28|0.905
73819140|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.19||||0.198|TWO_SIDED|95.0|-0.49|0.1|||Repeated measure model|||2 asthma exacerbations in the past year||0.10|-0.49|0.198
73819141|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.18||||0.226|TWO_SIDED|95.0|-0.47|0.11|||Repeated measure model|||2 asthma exacerbations in the past year||0.11|-0.47|0.226
73819142|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.14||||0.513|TWO_SIDED|95.0|-0.56|0.28|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.28|-0.56|0.513
73819143|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.974|TWO_SIDED|95.0|-0.43|0.42|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.42|-0.43|0.974
73819144|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.226|TWO_SIDED|95.0|-0.97|0.23|||Repeated measure model|||Chronic OCS use||0.23|-0.97|0.226
73819145|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.15||||0.613|TWO_SIDED|95.0|-0.44|0.75|||Repeated measure model|||Chronic OCS use||0.75|-0.44|0.613
73819146|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.17||||0.198|TWO_SIDED|95.0|-0.43|0.09|||Repeated measure model|||Without chronic OCS use||0.09|-0.43|0.198
73819147|NCT01402986|147185542|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.19||||0.165|TWO_SIDED|95.0|-0.45|0.08|||Repeated measure model|||Without chronic OCS use||0.08|-0.45|0.165
73819148|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.23||||0.211|TWO_SIDED|95.0|-0.13|0.6|||Repeated measure model|||Baseline serum periostin \>= median||0.60|-0.13|0.211
73819149|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.16||||0.397|TWO_SIDED|95.0|-0.21|0.53|||Repeated measure model|||Baseline serum periostin \>= median||0.53|-0.21|0.397
73819150|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.19||||0.315|TWO_SIDED|95.0|-0.18|0.56|||Repeated Measure Model|||Baseline serum periostin \< median||0.56|-0.18|0.315
73819151|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.26||||0.166|TWO_SIDED|95.0|-0.11|0.63|||Repeated measure model|||Baseline serum periostin \< median||0.63|-0.11|0.166
73819152|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.262||95.0|-0.13|0.47|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||0.47|-0.13|0.262
73819153|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.14||||0.379|TWO_SIDED|95.0|-0.17|0.44|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||0.44|-0.17|0.379
73819154|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.25||||0.387|TWO_SIDED|95.0|-0.32|0.81|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.81|-0.32|0.387
73819155|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.29||||0.303|TWO_SIDED|95.0|-0.26|0.84|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.84|-0.26|0.303
73819156|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.127|TWO_SIDED|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin \>=75th percentile||0.11|-0.84|0.127
73819157|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.775|TWO_SIDED|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin \>=75th percentile||0.42|-0.56|0.775
73819158|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.1||||0.512|TWO_SIDED|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.19|-0.38|0.512
73819159|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.404|TWO_SIDED|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.16|-0.40|0.404
73819160|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.31||||0.102|TWO_SIDED|95.0|-0.06|0.69|||Repeated measure model|||Th2 high||0.69|-0.06|0.102
73819161|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.3||||0.116|TWO_SIDED|95.0|-0.08|0.68|||Repeated measure model|||Th2 high||0.68|-0.08|0.116
73819162|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.11||||0.54|TWO_SIDED|95.0|-0.47|0.25|||Repeated measure model|||Th2 low||0.25|-0.47|0.540
73819163|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.674|TWO_SIDED|95.0|-0.42|0.27|||Repeated measure model|||Th2 low||0.27|-0.42|0.674
73819164|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.295|TWO_SIDED|95.0|-0.15|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count \>=150 cells/μL||0.49|-0.15|0.295
73819165|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.16||||0.342|TWO_SIDED|95.0|-0.17|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count \>=150 cells/μL||0.49|-0.17|0.342
73819166|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.18||||0.406|TWO_SIDED|95.0|-0.24|0.6|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.60|-0.24|0.406
73819167|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.38||||0.069|TWO_SIDED|95.0|-0.03|0.79|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.79|-0.03|0.069
73819168|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.19||||0.371|TWO_SIDED|95.0|-0.23|0.62|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.62|-0.23|0.371
73819169|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.07||||0.766|TWO_SIDED|95.0|-0.37|0.51|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.51|-0.37|0.766
73819170|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.24||||0.147|TWO_SIDED|95.0|-0.09|0.57|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.57|-0.09|0.147
73819171|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.35||||0.031|TWO_SIDED|95.0|0.03|0.68|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.68|0.03|0.031
73819172|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.59||||0.02|TWO_SIDED|95.0|0.1|1.09|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||1.09|0.10|0.020
73819173|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.29||||0.226|TWO_SIDED|95.0|-0.18|0.77|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.77|-0.18|0.226
73819174|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.01||||0.964|TWO_SIDED|95.0|-0.31|0.33|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.33|-0.31|0.964
73819175|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.1||||0.533|TWO_SIDED|95.0|-0.22|0.42|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.42|-0.22|0.533
73819176|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.292|TWO_SIDED|95.0|-0.15|0.5|||Repeated measure model|||2 asthma exacerbations in the past year||0.50|-0.15|0.292
73819177|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.27||||0.097|TWO_SIDED|95.0|-0.05|0.59|||Repeated measure model|||2 asthma exacerbations in the past year||0.59|-0.05|0.097
73819178|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.24||||0.26|TWO_SIDED|95.0|-0.18|0.67|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.67|-0.18|0.260
73819179|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.1||||0.648|TWO_SIDED|95.0|-0.33|0.53|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.53|-0.33|0.648
73819180|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.28||||0.398|TWO_SIDED|95.0|-0.37|0.93|||Repeated measure model|||Chronic OCS use||0.93|-0.37|0.398
73819181|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.32||||0.327|TWO_SIDED|95.0|-0.95|0.32|||Repeated measure model|||Chronic OCS use||0.32|-0.95|0.327
73819182|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.23||||0.105|TWO_SIDED|95.0|-0.05|0.52|||Repeated measure model|||Without chronic OCS use||0.52|-0.05|0.105
73819183|NCT01402986|147185543|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.31||||0.03|TWO_SIDED|95.0|0.03|0.6|||Repeated measure model|||Without chronic OCS use||0.60|0.03|0.030
73819184|NCT01402986|147185544|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.803|TWO_SIDED|95.0|0.62|1.44|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma||1.44|0.62|0.803
73819185|NCT01402986|147185544|SUPERIORITY_OR_OTHER||Rate Ratio|0.83||||0.457|TWO_SIDED|95.0|0.52|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma||1.35|0.52|0.457
73819186|NCT01402986|147185544|SUPERIORITY_OR_OTHER||Rate Ratio|0.71||||0.25|TWO_SIDED|95.0|0.4|1.27|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma||1.27|0.40|0.250
73819187|NCT01402986|147185544|SUPERIORITY_OR_OTHER||Rate Ratio|1.07||||0.794|TWO_SIDED|95.0|0.66|1.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma||1.74|0.66|0.794
73819188|NCT01402986|147185545|SUPERIORITY_OR_OTHER||Rate Ratio|1.2||||0.614|TWO_SIDED|95.0|0.59|2.46|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use||2.46|0.59|0.614
73819189|NCT01402986|147185545|SUPERIORITY_OR_OTHER||Rate Ratio|1.29||||0.506|TWO_SIDED|95.0|0.61|2.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use||2.74|0.61|0.506
73819190|NCT01402986|147185545|SUPERIORITY_OR_OTHER||Rate Ratio|0.79||||0.243||95.0|0.53|1.18|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use||1.18|0.53|0.243
73819191|NCT01402986|147185545|SUPERIORITY_OR_OTHER||Rate Ratio|0.87||||0.531|TWO_SIDED|95.0|0.57|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use||1.34|0.57|0.531
73819192|NCT02634983|147185563|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.11||0.0254|TWO_SIDED|90.0|1.4|8.6|||t-test, 2 sided|||Global Ventilated Lung Volume||8.60|1.40|0.0254
73819193|NCT02634983|147185564|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.77|STANDARD_ERROR_OF_MEAN|2.15||0.035|TWO_SIDED|90.0|1.11|8.44|||t-test, 2 sided|||Lung, Left Ventilation||8.44|1.11|0.0350
73819194|NCT02634983|147185564|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.96|STANDARD_ERROR_OF_MEAN|2.86||0.0946|TWO_SIDED|90.0|0.08|9.84|||t-test, 2 sided|||Lung, Left Lower Lobe Ventilation||9.84|0.08|0.0946
73819195|NCT02634983|147185564|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|2.41||0.0486|TWO_SIDED|90.0|0.87|9.07|||t-test, 2 sided|||Lung, Left Upper Lobe Ventilation||9.07|0.87|0.0486
73819196|NCT02634983|147185564|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|2.33||0.0286|TWO_SIDED|90.0|1.42|9.35|||t-test, 2 sided|||Lung, Right Ventilation||9.35|1.42|0.0286
73819197|NCT02634983|147185564|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|2.29||0.165|TWO_SIDED|90.0|-0.63|7.17|||t-test, 2 sided|||Lung, Right Lower Lobe Ventilation||7.17|-0.63|0.1650
73819198|NCT02634983|147185564|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|3.71||0.1421|TWO_SIDED|90.0|-0.71|11.94|||t-test, 2 sided|||Lung, Right Middle Lobe Ventilation||11.94|-0.71|0.1421
73819199|NCT02634983|147185564|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|7.73|STANDARD_ERROR_OF_MEAN|2.78||0.0099|TWO_SIDED|90.0|2.98|12.47|||t-test, 2 sided|||Lung, Right Upper Lobe Ventilation||12.47|2.98|0.0099
73819200|NCT02634983|147185565|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.92||0.323|TWO_SIDED|90.0|-0.64|2.5|||t-test, 2 sided|||Lung Perfusion||2.50|-0.64|0.3230
73819201|NCT02634983|147185565|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|0.95||0.1717|TWO_SIDED|90.0|-0.29|2.97|||t-test, 2 sided|||Lung, Left Perfusion||2.97|-0.29|0.1717
73819202|NCT02634983|147185565|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|1.02||0.5031|TWO_SIDED|90.0|-1.05|2.43|||t-test, 2 sided|||Lung, Left Lower Lobe Perfusion||2.43|-1.05|0.5031
73819203|NCT02634983|147185565|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|1.03||0.076|TWO_SIDED|90.0|0.15|3.65|||t-test, 2 sided|||Lung, Left Upper Lobe Perfusion||3.65|0.15|0.0760
73819204|NCT02634983|147185565|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.93||0.5465|TWO_SIDED|90.0|-1.02|2.16|||t-test, 2 sided|||Lung, Right Perfusion||2.16|-1.02|0.5465
73819205|NCT02634983|147185565|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|1.08||0.9913|TWO_SIDED|90.0|-1.85|1.87|||t-test, 2 sided|||Lung, Right Lower Lobe Perfusion||1.87|-1.85|0.9913
73819206|NCT02634983|147185565|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|1.7||0.3837|TWO_SIDED|90.0|-1.39|4.4|||t-test, 2 sided|||Lung, Right Middle Lobe Perfusion||4.40|-1.39|0.3837
73819207|NCT02634983|147185565|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.94||0.3624|TWO_SIDED|90.0|-0.73|2.48|||t-test, 2 sided|||Lung, Right Upper Lobe Perfusion||2.48|-0.73|0.3624
73819208|NCT02634983|147185566|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|90.0|0.11|0.18|||t-test, 2 sided|||FEV1 Day 1 (0.25 hrs post-dose)||0.18|0.11|<0.0001
73819209|NCT02634983|147185566|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.15|0.25|||t-test, 2 sided|||FEV1 Day 1 (1 hrs post-dose)||0.25|0.15|<0.0001
73819210|NCT02634983|147185566|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.13|0.24|||t-test, 2 sided|||FEV1 Day 1 (2 hrs post-dose)||0.24|0.13|<0.0001
73819211|NCT02634983|147185566|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.16|0.27|||t-test, 2 sided|||FEV1 Day 8 (-0.75 hrs post-dose)||0.27|0.16|<0.0001
73819212|NCT02634983|147185566|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.16|0.28|||t-test, 2 sided|||FEV1 Day 8 (-0.25 hrs post-dose)||0.28|0.16|<0.0001
73819213|NCT02634983|147185566|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.23|0.33|||t-test, 2 sided|||FEV1 Day 8 (0.25 hrs post-dose)||0.33|0.23|<0.0001
73819214|NCT02634983|147185566|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.26|0.37|||t-test, 2 sided|||FEV1 Day 8 (1 hrs post-dose)||0.37|0.26|<0.0001
73819215|NCT02634983|147185566|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|90.0|0.26|0.38|||t-test, 2 sided|||FEV1 Day 8 (2 hrs post-dose)||0.38|0.26|<0.0001
73819216|NCT02634983|147185567|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|90.0|0.15|0.33|||t-test, 2 sided|||FVC Day 1 (0.25 hrs post-dose)||0.33|0.15|<0.0001
73819217|NCT02634983|147185567|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 1 (1 hrs post-dose)||0.45|0.25|<0.0001
73819218|NCT02634983|147185567|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|90.0|0.2|0.42|||t-test, 2 sided|||FVC Day 1 (2 hrs post-dose)||0.42|0.20|<0.0001
73819219|NCT02634983|147185567|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 8 (-0.75 hrs post-dose)||0.45|0.25|<0.001
73819220|NCT02634983|147185567|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.19|0.37|||t-test, 2 sided|||FVC Day 8 (-0.25 hrs post-dose)||0.37|0.19|<0.0001
73819221|NCT02634983|147185567|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.33|0.53|||t-test, 2 sided|||FVC Day 8 (0.25 hrs post-dose)||0.53|0.33|<0.0001
73819222|NCT02634983|147185567|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.36|0.54|||t-test, 2 sided|||FVC Day 8 (1 hrs post-dose)||0.54|0.36|<0.0001
73819223|NCT02634983|147185567|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.33|0.55|||t-test, 2 sided|||FVC Day 8 (2 hrs post-dose)||0.55|0.33|<0.0001
73819224|NCT02634983|147185568|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.17|STANDARD_ERROR_OF_MEAN|0.56||0.0006|TWO_SIDED|90.0|1.21|3.12|||t-test, 2 sided|||FEV1/FVC Day 1 (0.25 hrs post-dose)||3.12|1.21|0.0006
73819225|NCT02634983|147185568|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|0.75||0.0106|TWO_SIDED|90.0|0.78|3.33|||t-test, 2 sided|||FEV1/FVC Day 1 (1 hrs post-dose)||3.33|0.78|0.0106
73819226|NCT02634983|147185568|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|0.66||0.0013|TWO_SIDED|90.0|1.2|3.44|||t-test, 2 sided|||FEV1/FVC Day 1 (2 hrs post-dose)||3.44|1.20|0.0013
73819227|NCT02634983|147185568|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.82|STANDARD_ERROR_OF_MEAN|0.83||0.0017|TWO_SIDED|90.0|1.41|4.23|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.75 hrs post-dose)||4.23|1.41|0.0017
73819228|NCT02634983|147185568|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|90.0|2.51|5.09|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.25 hrs post-dose)||5.09|2.51|<0.0001
73819229|NCT02634983|147185568|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.74|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|90.0|2.45|5.02|||t-test, 2 sided|||FEV1/FVC Day 8 (0.25 hrs post-dose)||5.02|2.45|<0.0001
73819230|NCT02634983|147185568|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|90.0|3.16|6.03|||t-test, 2 sided|||FEV1/FVC Day 8 (1 hrs post-dose)||6.03|3.16|<0.0001
73819231|NCT02634983|147185568|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.98|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|90.0|3.56|6.39|||t-test, 2 sided|||FEV1/FVC Day 8 (2 hrs post-dose)||6.39|3.56|<0.0001
73819232|NCT02634983|147185569|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.36||0.982|TWO_SIDED|90.0|-0.62|0.6|||t-test, 2 sided|||Lung Clearance Index||0.60|-0.62|0.9820
73819233|NCT02634983|147185570|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.36||0.0821|TWO_SIDED|90.0|0.04|1.27|||t-test, 2 sided|||Diffusion Capacity of Lung for CO||1.27|0.04|0.0821
73819234|NCT03951753|147185589|OTHER||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.107|<|0.001|TWO_SIDED|95.0|0.87|1.29|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||1.29|0.87|<0.001
73819235|NCT03951753|147185589|OTHER||Least Squares Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|0.166|<|0.001|TWO_SIDED|95.0|1.59|2.24|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||2.24|1.59|<0.001
73819236|NCT03951753|147185589|OTHER||Least Squares Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.192|<|0.001|TWO_SIDED|95.0|0.46|1.21|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||1.21|0.46|<0.001
73819237|NCT03951753|147185590|OTHER||Least Squares Mean Difference|-38.1|||<|0.001|TWO_SIDED|95.0|-45.4|-30.7|||ANCOVA|||||-30.7|-45.4|<0.001
73819238|NCT03951753|147185590|OTHER||Least Squares Mean Difference|-47.1|||<|0.001|TWO_SIDED|95.0|-54.6|-39.5|||ANCOVA|||||-39.5|-54.6|<0.001
73819239|NCT03951753|147185590|OTHER||Least Squares Mean Difference|-9.0||||0.006|TWO_SIDED|95.0|-15.4|-2.6|||ANCOVA|||||-2.6|-15.4|0.006
73819240|NCT03951753|147185591|OTHER||Least Squares Mean Difference|-14696.1|||<|0.001|TWO_SIDED|95.0|-17045.0|-12347.3|||ANCOVA|||||-12347.3|-17045.0|<0.001
73819241|NCT03951753|147185591|OTHER||Least Squares Mean Difference|-17873.2|||<|0.001|TWO_SIDED|95.0|-20239.0|-15507.4|||ANCOVA|||||-15507.4|-20239.0|<0.001
73819242|NCT03951753|147185591|OTHER||Least Squares Mean Difference|-3177.1||||0.002|TWO_SIDED|95.0|-5194.3|-1159.8|||ANCOVA|||||-1159.8|-5194.3|0.002
73819243|NCT03951753|147185592|OTHER||Least Squares Mean Difference|-1.93|||<|0.001|TWO_SIDED|95.0|-2.18|-1.67|||Mixed Models Analysis|||||-1.67|-2.18|<0.001
73819244|NCT03951753|147185592|OTHER||Least Squares Mean Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-2.58|-2.08|||Mixed Models Analysis|||||-2.08|-2.58|<0.001
73819245|NCT03951753|147185592|OTHER||Least Squares Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.63|-0.19|||Mixed Models Analysis|||||-0.19|-0.63|<0.001
73819246|NCT03951753|147185593|OTHER||Least Squares Mean Difference|279.14|STANDARD_ERROR_OF_MEAN|17.366|<|0.001|TWO_SIDED|95.0|245.1|313.18|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||313.18|245.10|<0.001
73819247|NCT03951753|147185593|OTHER||Least Squares Mean Difference|381.23|STANDARD_ERROR_OF_MEAN|21.399|<|0.001|TWO_SIDED|95.0|339.29|423.17|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||423.17|339.29|<0.001
73819248|NCT03951753|147185593|OTHER||Least Squares Mean Difference|102.09|STANDARD_ERROR_OF_MEAN|25.635|<|0.001|TWO_SIDED|95.0|51.84|152.33|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||152.33|51.84|<0.001
73819249|NCT03951753|147185594|OTHER||Least Squares Mean Difference|11.3|||<|0.001|TWO_SIDED|95.0|4.9|17.7|||ANCOVA|||||17.7|4.9|<0.001
73819250|NCT03951753|147185594|OTHER||Least Squares Mean Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.4|26.1|||ANCOVA|||||26.1|13.4|<0.001
73819251|NCT03951753|147185594|OTHER||Least Squares Mean Difference|8.5||||0.003|TWO_SIDED|95.0|3.0|14.0|||ANCOVA|||||14.0|3.0|0.003
73819252|NCT03951753|147185595|OTHER||Least Squares Mean Difference|-3.6|||<|0.001|TWO_SIDED|95.0|-5.5|-1.8|||ANCOVA|||||-1.8|-5.5|<0.001
73819253|NCT03951753|147185595|OTHER||Least Squares Mean Difference|-4.5|||<|0.001|TWO_SIDED|95.0|-6.3|-2.6|||ANCOVA|||||-2.6|-6.3|<0.001
73819254|NCT03951753|147185595|OTHER||Least Squares Mean Difference|-0.8||||0.277|TWO_SIDED|95.0|-2.4|0.7|||ANCOVA|||||0.7|-2.4|0.277
73819255|NCT03951753|147185596|OTHER||Slope|-296.1||||0.044|TWO_SIDED|95.0|-584.8|-7.5|||ANCOVA|||||-7.5|-584.8|0.044
73819256|NCT03951753|147185596|OTHER||Least Squares Mean Difference|-637.7|||<|0.001|TWO_SIDED|95.0|-925.2|-350.2|||ANCOVA|||||-350.2|-925.2|<0.001
73819257|NCT03951753|147185596|OTHER||Least Squares Mean Difference|-341.6||||0.006|TWO_SIDED|95.0|-585.2|-97.9|||ANCOVA|||||-97.9|-585.2|0.006
73819258|NCT03951753|147185597|OTHER||Least Squares Mean Difference|-245.5|||<|0.001|TWO_SIDED|95.0|-357.7|-133.3|||Mixed Models Analysis|||||-133.3|-357.7|<0.001
73819259|NCT03951753|147185597|OTHER||Least Squares Mean Difference|-309.8|||<|0.001|TWO_SIDED|95.0|-423.0|-196.6|||Mixed Models Analysis|||||-196.6|-423.0|<0.001
73819260|NCT03951753|147185597|OTHER||Least Squares Mean Difference|-64.3||||0.187|TWO_SIDED|95.0|-160.3|31.7|||Mixed Models Analysis|||||31.7|-160.3|0.187
73819261|NCT04633291|147185611|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard Male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|0.04||||0.88|TWO_SIDED|95.0|-0.5|0.58||The threshold for statistical significance was set at 0.05|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.58|-0.50|0.88
73819262|NCT04633291|147185612|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|-0.14||||0.62|TWO_SIDED|95.0|-0.72|0.44||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.44|-0.72|0.62
73819263|NCT04633291|147185613|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|0.11||||0.63|TWO_SIDED|95.0|-0.36|0.57||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.57|-0.36|0.63
73896517|NCT00913458|147326254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.56||||0.0713|TWO_SIDED|95.0|-26.2|1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||1.1|-26.2|0.0713
73819264|NCT04633291|147185614|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|-0.15||||0.19|TWO_SIDED|95.0|-0.38|0.08||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.08|-0.38|0.19
73819265|NCT04633291|147185615|SUPERIORITY||Odds Ratio (OR)|1.76||||0.381|TWO_SIDED|95.0|0.47|6.6||The threshold for statistical significance was set at 0.05.|Proportional odds model|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is evaluated easier than the comparator. OR \<1 means that the comparator device is evaluated easier than the investigational device.|Null hypothesis: No difference between the devices.||6.60|0.47|0.381
73819266|NCT04633291|147185616|SUPERIORITY||Odds Ratio (OR)|7.8||||0.541|TWO_SIDED|95.0|-18.4|34.0||The threshold for statistical significance was set at 0.05.|Proportional odds model|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|"OR=1 corresponds to exact equality. OR \>1 means that the investigational device is evaluated easier than the comparator. OR \<1 means that the comparator device is evaluated easier than the investigational device.~Of note: Log transformed estimates."|Null hypothesis: No difference between the devices.||34.00|-18.40|0.541
73819267|NCT04633291|147185617|SUPERIORITY||Odds Ratio (OR)|7.17||||0.269|TWO_SIDED|95.0|0.19|265.95||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||265.95|0.19|0.269
73819268|NCT04633291|147185618|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.02|64.83||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||64.83|0.02|1.0
73819269|NCT04633291|147185619|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.08|12.87||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||12.87|0.08|1.0
73819270|NCT00076258|147185620|SUPERIORITY_OR_OTHER_LEGACY||Remission rate|29.5|||<|0.05|TWO_SIDED||||||Generalized Linear Mixed Model|Both unadjusted and adjusted rates (for significant covariates) were reported||||||<0.05
73819271|NCT00076258|147185620|SUPERIORITY_OR_OTHER_LEGACY||Remission Rate|28.3|||<|0.05|TWO_SIDED||||||Generalized Linear Mixed Model|||For the covariate adjusted GLMM the remission rates were 15.5 for the LD and 28.3 for the PHD with a p \< 0.06 and the NNT of 7.8 for the PHD versus the LD.||||<0.05
73819272|NCT02371668|147185669|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
73819273|NCT02371668|147185670|SUPERIORITY|||||||0.114|||||||Fisher Exact|||||||0.114
73819274|NCT02371668|147185671|SUPERIORITY|||||||0.4989|||||||Wilcoxon (Mann-Whitney)|||||||0.4989
73819275|NCT02371668|147185672|SUPERIORITY|||||||0.1412|||||||Wilcoxon (Mann-Whitney)|||||||0.1412
73819276|NCT02371668|147185673|SUPERIORITY|||||||0.137|||||||Fisher Exact|||||||0.137
73819277|NCT02371668|147185674|SUPERIORITY|||||||0.2445|||||||Wilcoxon (Mann-Whitney)|||||||0.2445
73819278|NCT02371668|147185675|SUPERIORITY|||||||0.045|||||||Fisher Exact|||||||0.045
73819279|NCT02371668|147185676|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.230
73819280|NCT02371668|147185677|SUPERIORITY|||||||0.646|||||||Fisher Exact|||||||0.646
73819281|NCT00398216|147185682|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
73819282|NCT00398216|147185682|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73819283|NCT00398216|147185682|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73819284|NCT00398216|147185682|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
73819285|NCT00398216|147185685|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Fisher Exact|||||||.250
73819286|NCT00398216|147185685|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||Fisher Exact|||||||.122
73819287|NCT00398216|147185685|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED||||||Fisher Exact|||||||.124
73819288|NCT00398216|147185685|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||Fisher Exact|||||||.123
73819289|NCT04227405|147185689|SUPERIORITY||Slope|0.24|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change between pre-test and post-test for the Positive Conflict Management subscale using multilevel modeling||||>.05
73896518|NCT00913458|147326256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.11||||0.0256|TWO_SIDED|95.0|-17.1|-1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-1.1|-17.1|0.0256
73819290|NCT04227405|147185689|SUPERIORITY||Slope|1.59|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change between pre-test and post-test for the Positive Conflict Management subscale using multilevel modeling||||<.001
73819291|NCT04227405|147185689|SUPERIORITY||Slope|1.35|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Positive Conflict Management subscale||||<.001
73819292|NCT04227405|147185689|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in Negative Conflict Management for the Control Group||||>.05
73819293|NCT04227405|147185689|SUPERIORITY||Slope|-1.48|STANDARD_ERROR_OF_MEAN|0.29|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in the Negative Conflict Management subscale||||<.01
73819294|NCT04227405|147185689|SUPERIORITY||Slope|-1.0|STANDARD_ERROR_OF_MEAN|0.36|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Negative Conflict Management subscale||||<.01
73819295|NCT04227405|147185689|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes in the Relationship Quality subscale from Pre-test to post-test in the control group||||<.05
73819296|NCT04227405|147185689|SUPERIORITY||Slope|0.86|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes in the Relationship Quality Subscale from pretest to posttest in the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
73819297|NCT04227405|147185689|SUPERIORITY||Slope|0.53|STANDARD_ERROR_OF_MEAN|0.22|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Qualitty subscale|The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.05
73819298|NCT04227405|147185689|SUPERIORITY||Slope|-0.32|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Emotional Abuse subscale for the control group||||<.05
73819299|NCT04227405|147185689|SUPERIORITY||Slope|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to posttest in the Emotional Abuse subscale for the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
73819300|NCT04227405|147185689|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Emotional Abuse subscale|The expected decrease from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.05
73819301|NCT04227405|147185689|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to posttest in the Relationship Satisfaction subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
73819302|NCT04227405|147185689|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Changes from pre-test to posttest in the Relationship satisfaction subscale for the intervention group||||<.001
73819303|NCT04227405|147185689|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Satisfactionn subscale||||<.001
73819304|NCT04227405|147185689|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Relationship Commitment subscale for the control group||||>.05
73819305|NCT04227405|147185689|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Relationship Commitment subscale for the intervention group||||<.001
73819306|NCT04227405|147185689|SUPERIORITY||Slope|0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Commitment subscale||||<.001
73819307|NCT04227405|147185689|SUPERIORITY||Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Depression subscale for the control group||||<.001
73819308|NCT04227405|147185689|SUPERIORITY||Slope|-0.81|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Changes from pre-test to posttest in the Depression subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
73819309|NCT04227405|147185689|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Depression subscale||||>.05
73819310|NCT04227405|147185689|SUPERIORITY||Slope|-0.26|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Anxiety subscale for the control group||||>.05
73819311|NCT04227405|147185689|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Anxiety subscale for the intervention group||||<.001
73819312|NCT04227405|147185689|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test and post-test in the intervention group were not significantly different from the change from pre-test and post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Anxiety subscale||||>.05
73819313|NCT04227405|147185689|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Budgeting subscale for the control group||||<.05
73819314|NCT04227405|147185689|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Budgeting subscale for the intervention group||||<.001
73819315|NCT04227405|147185689|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Budgeting subscale||||<.10
73819316|NCT04227405|147185689|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Difficulties to Pay Bills subscale for the control group||||<.10
73819317|NCT04227405|147185689|SUPERIORITY||Slope|-0.21|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Difficulties to Pay Bills subscale for the intervention group||||<.001
73819318|NCT04227405|147185689|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Difficulties to Pay Bills subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|||>.05
73819319|NCT04227405|147185689|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Time with Partner subscale for the control group||||>.05
73819320|NCT04227405|147185689|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Time with Partner subscale for the intervention group||||<.05
73819321|NCT04227405|147185689|SUPERIORITY||Slope|0.16|STANDARD_ERROR_OF_MEAN|0.17|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to pos-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Time with Partner subscale||||>.05
73819322|NCT04227405|147185689|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Positive values indicate an increase whereas a negative value indicates a decrease|Change from pre-test to post-test in banking subscale for control group||||>.05
73819323|NCT04227405|147185689|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in banking subscale for the intervention group||||>.05
73819324|NCT04227405|147185689|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in Banking subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|||>.05
73819325|NCT04227405|147185689|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in parenting stress subscale for the control group||||>.05
73819326|NCT04227405|147185689|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in parenting stress subscale for the intervention group||||>.05
73819327|NCT04227405|147185689|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Parenting stresss subscale||||>.05
73819328|NCT04227405|147185689|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in conflict management satisfaction subscale for the control group||||<.001
73819329|NCT04227405|147185689|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in conflict management satisfaction subscale for the intervention group||||<.001
73819330|NCT04227405|147185689|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||The increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Conflict Management Satisfaction subscale||||<.001
73819331|NCT04227405|147185690|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.28|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Positive Conflict Management subscale for the control group||||>.05
73819332|NCT04227405|147185690|SUPERIORITY||Slope|1.53|STANDARD_ERROR_OF_MEAN|0.35|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Positive Conflict Management subscale for the intervention group||||<.001
73819333|NCT04227405|147185690|SUPERIORITY||Slope|1.35|STANDARD_ERROR_OF_MEAN|0.44|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Positive Conflict Management subscale|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Positive Conflict Management subscale||||<.01
73819334|NCT04227405|147185690|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.28|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Negative Conflict subscale for the control group||||>.05
73819335|NCT04227405|147185690|SUPERIORITY||Slope|-1.4|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to Follow-up in the Negative Conflict Manageement subscale for the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
73819336|NCT04227405|147185690|SUPERIORITY||Slope|-0.99|STANDARD_ERROR_OF_MEAN|0.44|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to follow-i\[in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Negative Conflict Management subscale||||<.01
73819337|NCT04227405|147185690|SUPERIORITY||Slope|0.41|STANDARD_ERROR_OF_MEAN|0.17|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Quality subscale for the control group||||>.05
73819338|NCT04227405|147185690|SUPERIORITY||Slope|0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Quality subscale for the intervention group||||<.001
73819339|NCT04227405|147185690|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.26|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables. Pvalue set at \<.05|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is not significantly (p \> .05) different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Relationship Quality subscale||||<.10
73819340|NCT04227405|147185690|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|0.13|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Emotional Abuse subscale for the control group||||<.10
73819341|NCT04227405|147185690|SUPERIORITY||Slope|-0.71|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Emotional Abuse subscale for the intervention group||||<.001
73819342|NCT04227405|147185690|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to follow-up in the intervention group is not significantly (p \> .05) different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Emotional Abuse subscale||||<.10
73819343|NCT04227405|147185690|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship subscale for the control group||||>.05
73819344|NCT04227405|147185690|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Satisfaction subscale for the intervention group||||<.001
73819345|NCT04227405|147185690|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Relationship Satisfaction subscale||||<.001
73819346|NCT04227405|147185690|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Commitment subscale for the control group||||>.05
73819347|NCT04227405|147185690|SUPERIORITY||Slope|0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Commitment subscale for the intervention group||||<.001
73819348|NCT04227405|147185690|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Relationship Commitment subscale||||<.001
73819349|NCT04227405|147185690|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Positive Conflict Management subscale for the control group||||>.05
73819350|NCT04227405|147185690|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Positive Conflict Management subscale for th eintervention group||||>.05
73819351|NCT04227405|147185690|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Positive Conflict Management subscale||||>.05
73819352|NCT04227405|147185690|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Negative Conflict Management subscale for the control group||||>.05
73819353|NCT04227405|147185690|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Negative Conflict Management subscale for the intervention group||||>.05
73819354|NCT04227405|147185690|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Negative Conflict Management subscale||||>.05
73819355|NCT04227405|147185690|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Quality subscale for the control group||||>.05
73819356|NCT04227405|147185690|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Quality subscale for the intervention group||||>.05
73819357|NCT04227405|147185690|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship Quality subscale||||>.05
73819358|NCT04227405|147185690|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group||||>.05
73819359|NCT04227405|147185690|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Emotional Abuse subscale for the intervention group||||>.05
73819360|NCT04227405|147185690|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Emotional Abuse subscale||||>.05
73819361|NCT04227405|147185690|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.01|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Satisfaction subscale for the control group||||>.05
73819362|NCT04227405|147185690|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Satisfaction subscale for the interventionn group||||>.05
73819363|NCT04227405|147185690|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship satisfaction subscale||||>.05
73819364|NCT04227405|147185690|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group|Changes from post-test to Follow-up in the Relationship Commitment subscale for the control group||||>.05
73819365|NCT04227405|147185690|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Commitment subscale for the intervention group||||>.05
73819366|NCT04227405|147185690|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship Commitment subscale||||>.05
73819367|NCT04227405|147185690|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in banking subscale for the control group||||>.05
73819368|NCT04227405|147185690|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in banking subscale for the intervention group||||>.05
73819369|NCT04227405|147185690|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Banking subscale||||>.05
73819370|NCT04227405|147185690|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the control group||||<.001
73819371|NCT04227405|147185690|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the intervention group||||<.001
73819372|NCT04227405|147185690|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.03|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Banking subscale|Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|||<.10
73819373|NCT04227405|147185690|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Difficulty to Pay Bills for the control group||||>.05
73819374|NCT04227405|147185690|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Difficulties to Pay Bills subscale for the intervention group||||<.05
73819375|NCT04227405|147185690|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Difficulties to pay bills subscale||||>.05
73819376|NCT04227405|147185690|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Difficulty to Pay Bills subscale for the control group||||>.05
73819377|NCT04227405|147185690|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Difficulties to Pay Bills subscale for the intervention group||||>.05
73819378|NCT04227405|147185690|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in Difficulty to Pay Bills subscale||||>.05
73819379|NCT04227405|147185690|SUPERIORITY||Slope|-0.69|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||No adjustment to p vallue|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in depression subscale for the control group||||<.001
73819380|NCT04227405|147185690|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in depression subscale for the intervention group||||<.001
73819381|NCT04227405|147185690|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Depression subscale||||>.05
73819382|NCT04227405|147185690|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in depression subscale for the control group||||>.05
73819383|NCT04227405|147185690|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in depression subscale for the intervention group||||>.05
73819384|NCT04227405|147185690|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in depression subscale||||>.05
73819385|NCT04227405|147185690|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Change from pre-test to follow-up in the Anxiety subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.05
73819386|NCT04227405|147185690|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the Anxiety subscale for the intervention group||||<.05
73819387|NCT04227405|147185690|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Anxiety subscale||||>.05
73819388|NCT04227405|147185690|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in anxiety subscale for the control group||||>.05
73819389|NCT04227405|147185690|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in anxiety subscale for the control group||||>.05
73819390|NCT04227405|147185690|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in the Anxiety subscale||||>.05
73819391|NCT04227405|147185690|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in parenting stress subscale for the control group||||>.05
73819392|NCT04227405|147185690|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in parenting stress subscale for the intervention group||||>.05
73819393|NCT04227405|147185690|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in parenting stress subscale|Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|||>.05
73819394|NCT04227405|147185690|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the control group||||<.05
73819395|NCT04227405|147185690|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in parenting stress subscale for the control group||||>.05
73819396|NCT04227405|147185690|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in Parenting Stress subscale||||>.05
73819397|NCT04227405|147185690|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.13|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Time with Partner subscale for the control group||||<.10
73819398|NCT04227405|147185690|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Time with Parter subscale for the intervention group||||>.05
73819399|NCT04227405|147185690|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.2|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up inn Time with Partner subscale||||>.05
73819400|NCT04227405|147185690|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Time with Partner subscale for the control group||||<.001
73819401|NCT04227405|147185690|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Time with Partner subscale for the intervention group||||>.05
73819402|NCT04227405|147185690|SUPERIORITY||Slope|0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Time with Partner subscale|Changes from post-test to follow-up in the intervention group were significantly different from the change from post-test to follow-up in the control group|||<.001
73819403|NCT04227405|147185690|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Conflict Management Satisfaction subscale for the control group||||<.05
73819404|NCT04227405|147185690|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Conflict Management Satisfaction subscale for the control group||||<.001
73819405|NCT04227405|147185690|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Conflict Management Satisfaction subscale||||<.05
73819406|NCT04227405|147185690|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Conflict Management Satisfaction subscale for the control group||||>.05
73819407|NCT04227405|147185690|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in conflict management satisfaction subscale for the intervention group||||>.05
73819408|NCT04227405|147185690|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Conflict Management Satisfaction subscale|Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|||>.05
73819409|NCT04227405|147185690|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in budgeting subscale for the control group||||<.10
73819410|NCT04227405|147185690|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Budgeting subscale for the intervention group||||<.05
73819411|NCT04227405|147185690|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.07|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in Budgeting subscale|Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|||<.01
73819412|NCT04227405|147185690|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in budgeting subscale for the control group||||<.001
73819413|NCT04227405|147185690|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in budgeting subscale for the intervention group||||<.001
73819414|NCT04227405|147185690|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in Budgeting subscale|Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|||<.001
73819415|NCT04227405|147185692|SUPERIORITY||Slope|-0.35|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Acceptance subscale for the control group||||<.05
73819416|NCT04227405|147185692|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Acceptance subscale for the intervention group||||<.05
73819417|NCT04227405|147185692|SUPERIORITY||Slope|0.68|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Acceptance subscale||||<.001
73819418|NCT04227405|147185692|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the control group||||<.05
73819419|NCT04227405|147185692|SUPERIORITY||Slope|0.38|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the intervention group||||<.05
73819420|NCT04227405|147185692|SUPERIORITY||Slope|0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Active Coping subscale|The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.001
73819421|NCT04227405|147185692|SUPERIORITY||Slope|-0.32|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the control group||||<.05
73819422|NCT04227405|147185692|SUPERIORITY||Slope|0.44|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the intervention group||||<.01
73819423|NCT04227405|147185692|SUPERIORITY||Slope|0.76|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Planning subscale||||<.001
73819424|NCT04227405|147185692|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the control group||||>.05
73819425|NCT04227405|147185692|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the intervention group||||>.05
73819426|NCT04227405|147185692|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Instrumental Support subscale||||>.05
73819427|NCT04227405|147185693|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.14|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the control group||||<.10
73819428|NCT04227405|147185693|SUPERIORITY||Slope|0.41|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the intervention group||||<.05
73819429|NCT04227405|147185693|SUPERIORITY||Slope|0.77|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Aceptance subscale||||<.001
73819430|NCT04227405|147185693|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the control group||||<.10
73819431|NCT04227405|147185693|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the intervention group||||<.05
73819432|NCT04227405|147185693|SUPERIORITY||Slope|0.76|STANDARD_ERROR_OF_MEAN|0.22|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Active Coping subscale||||<.01
73819433|NCT04227405|147185693|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the control group||||<.10
73819434|NCT04227405|147185693|SUPERIORITY||Slope|0.59|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the intervention group||||<.05
73819435|NCT04227405|147185693|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Planning subscale||||<.001
73819436|NCT04227405|147185693|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
73819437|NCT04227405|147185693|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the Intervention group||||>.05
73819438|NCT04227405|147185693|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Instrumental Support subscale||||>.05
73819439|NCT04227405|147185693|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the control group||||>.05
73819440|NCT04227405|147185693|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the intervention group||||>.05
73819441|NCT04227405|147185693|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Positive Conflict Management subscale||||>.05
73819442|NCT04227405|147185693|SUPERIORITY|Changes from post-test to Follow-up in the Active Coping subscale for the control group|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|||||>.05
73819443|NCT04227405|147185693|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping subscale for the intervention group||||>.05
73819444|NCT04227405|147185693|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Active Copinng subscale||||>.05
73819445|NCT04227405|147185693|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Plannning subscale for the control group||||>.05
73819446|NCT04227405|147185693|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.06|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the intervention group||||<.10
73819447|NCT04227405|147185693|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Planning subscale||||>.05
73819448|NCT04227405|147185693|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
73819449|NCT04227405|147185693|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the intervention group||||>.05
73819450|NCT04227405|147185693|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Instrumental Support subscale||||>.05
73819451|NCT04227405|147185695|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to Follow-up in the Emotional Abuse subscale for the control group|Changes from pre-test to posttest in the Acceptance subscale for the control group||||<.05
73819452|NCT04227405|147185695|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.16|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Emotional Abuse subscale for the control group||||<.01
73819453|NCT04227405|147185695|SUPERIORITY||Slope|0.77|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Acceptance subscale||||<.001
73819454|NCT04227405|147185695|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the control group||||>.05
73819455|NCT04227405|147185695|SUPERIORITY||Slope|0.3|STANDARD_ERROR_OF_MEAN|0.17|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the intervention group||||<.10
73819456|NCT04227405|147185695|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Active Coping subscale||||<.05
73819457|NCT04227405|147185695|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the control group||||<.05
73819458|NCT04227405|147185695|SUPERIORITY||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the Intervention group||||<.05
73819459|NCT04227405|147185695|SUPERIORITY||Slope|0.74|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Planning subscale||||<.001
73819460|NCT04227405|147185695|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the control group||||>.05
73819461|NCT04227405|147185695|SUPERIORITY||Slope|0.49|STANDARD_ERROR_OF_MEAN|0.16|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the intervention group||||<.01
73819462|NCT04227405|147185695|SUPERIORITY||Slope|0.6|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Instrumental Support subscale||||<.01
73819463|NCT04227405|147185696|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the control group||||>.05
73819464|NCT04227405|147185696|SUPERIORITY||Slope|0.52|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the intervention group||||<.01
73819465|NCT04227405|147185696|SUPERIORITY||Slope|0.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.01|TWO_SIDED||||||Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Acceptance subscale|The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|||<.01
73819466|NCT04227405|147185696|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the control group||||>.05
73819467|NCT04227405|147185696|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the intervention group||||<.10
73819468|NCT04227405|147185696|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.1|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Active Coping subscale||||<.10
73819469|NCT04227405|147185696|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the control group||||<.10
73819470|NCT04227405|147185696|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the intervention group||||<.05
73819471|NCT04227405|147185696|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.23|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Planning subscale||||<.01
73819472|NCT04227405|147185696|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
73819473|NCT04227405|147185696|SUPERIORITY||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the intervention group||||<.01
73819474|NCT04227405|147185696|SUPERIORITY||Slope|0.66|STANDARD_ERROR_OF_MEAN|0.24|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Instrumental Support subscale||||<.01
73819475|NCT04227405|147185696|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the control group||||>.05
73819476|NCT04227405|147185696|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the interventionn group||||>.05
73819477|NCT04227405|147185696|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Acceptance subscale||||>.05
73819478|NCT04227405|147185696|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping subscale for the control group||||>.05
73819479|NCT04227405|147185696|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping in the intervention group||||>.05
73819480|NCT04227405|147185696|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Active Coping subscale||||>.05
73819481|NCT04227405|147185696|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the control group||||>.05
73819482|NCT04227405|147185696|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the intervention group||||>.05
73819483|NCT04227405|147185696|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in Planning subscale||||>.05
73819484|NCT04227405|147185696|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
73819485|NCT04227405|147185696|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.06|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the intervention group||||<.10
73819486|NCT04227405|147185696|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Instrumental Supportt subscale||||>.05
73819487|NCT04227405|147185698|SUPERIORITY||Slope|-1.41|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED||||||Multilevel modeling|||Changes from pre-test to posttest for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.05
73819488|NCT04227405|147185698|SUPERIORITY||Slope|2.02|STANDARD_ERROR_OF_MEAN|0.69|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest for the intervention group||||<.01
73819489|NCT04227405|147185698|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.83|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to post-test t in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||>.05
73819490|NCT04227405|147185699|SUPERIORITY||Slope|-1.48|STANDARD_ERROR_OF_MEAN|0.6|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up for the control group||||>.05
73819491|NCT04227405|147185699|SUPERIORITY||Slope|-1.5|STANDARD_ERROR_OF_MEAN|0.82|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up for the intervention group||||<.10
73819492|NCT04227405|147185699|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|1.01|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up||||>.05
73819493|NCT04227405|147185699|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up for the control group||||>.05
73819494|NCT04227405|147185699|SUPERIORITY||Slope|-0.52|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up for the control group||||>.05
73819495|NCT04227405|147185699|SUPERIORITY||Slope|-0.6|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up||||>.05
73819496|NCT04227405|147185701|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|1.16|>|0.05|TWO_SIDED|||||No adjustment for p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in Difficulties in Emotion Regulation for the control group||||>.05
73819497|NCT04227405|147185701|SUPERIORITY||Slope|-3.07|STANDARD_ERROR_OF_MEAN|1.51|<|0.05|TWO_SIDED|||||No adjustment for p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.05
73819498|NCT04227405|147185701|SUPERIORITY||Slope|-2.74|STANDARD_ERROR_OF_MEAN|1.85|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||>.05
73819499|NCT04227405|147185702|SUPERIORITY||Slope|-0.7|STANDARD_ERROR_OF_MEAN|1.41|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Change from pre-test to follow-up for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
73819500|NCT04227405|147185702|SUPERIORITY||Slope|-2.74|STANDARD_ERROR_OF_MEAN|1.79|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group||||>.05
73819501|NCT04227405|147185702|SUPERIORITY||Slope|-2.04|STANDARD_ERROR_OF_MEAN|2.24|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up||||>.05
73819502|NCT04227405|147185702|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.46|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
73819503|NCT04227405|147185702|SUPERIORITY||Slope|-0.33|STANDARD_ERROR_OF_MEAN|0.5|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
73819504|NCT04227405|147185702|SUPERIORITY||Slope|-0.69|STANDARD_ERROR_OF_MEAN|0.68|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
73819505|NCT04227405|147185704|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in psychological agggression subscale for the control group||||<.001
73819506|NCT04227405|147185704|SUPERIORITY||Slope|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in psychological aggression subscale for the intervention group||||<.001
73819507|NCT04227405|147185704|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.17|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Psychological Aggression subscale||||<.10
73819508|NCT04227405|147185704|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Change from pre-test to post-test in physical assault subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
73819509|NCT04227405|147185704|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in the physical assault subscale for the intervention group||||<.001
73819510|NCT04227405|147185704|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Physical Assault subscale||||<.05
73819511|NCT04227405|147185705|SUPERIORITY||Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the psychological aggression subscale for the control group||||<.001
73819512|NCT04227405|147185705|SUPERIORITY||Slope|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the Psychological Aggression subscale for the intervention group||||<.001
73819513|NCT04227405|147185705|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.21|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up inn the psychological aggression subscale||||>.05
73819514|NCT04227405|147185705|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group in the psychological aggression subscale||||<.10
73819515|NCT04227405|147185705|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the intervention group for the psychological aggresssion subscale||||>.05
73819516|NCT04227405|147185705|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in the psychological aggression subscale||||>.05
73819517|NCT04227405|147185705|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the physical assault subscale||||>.05
73819518|NCT04227405|147185705|SUPERIORITY||Slope|-0.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the Physical Assault Subscale||||<.05
73819519|NCT04227405|147185705|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up for the Physical Assault subscale||||<.05
73819520|NCT04227405|147185705|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group for the Physical Assault subscale||||>.05
73819521|NCT04227405|147185705|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the intervention group for the Physical Assault subscale||||>.05
73819522|NCT04227405|147185705|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
73819523|NCT04227405|147185707|SUPERIORITY||Slope|-2.12|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group||||<.001
73819524|NCT04227405|147185707|SUPERIORITY||Slope|-4.46|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.001
73819525|NCT04227405|147185707|SUPERIORITY||Slope|-2.34|STANDARD_ERROR_OF_MEAN|0.89|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Time||||<.05
73819526|NCT04227405|147185708|SUPERIORITY||Slope|-1.96|STANDARD_ERROR_OF_MEAN|0.7|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group||||<.05
73819527|NCT04227405|147185708|SUPERIORITY||Slope|-4.48|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the intervention group||||<.001
73819528|NCT04227405|147185708|SUPERIORITY||Slope|-2.52|STANDARD_ERROR_OF_MEAN|1.1|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up||||<.05
73819529|NCT04227405|147185708|SUPERIORITY||Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.24|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
73819530|NCT04227405|147185708|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
73819531|NCT04227405|147185708|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.35|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
73819532|NCT04227405|147185710|SUPERIORITY||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.24|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for Supportive Dyadic Coping subscale||||>.05
73819533|NCT04227405|147185710|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.31|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.05
73819534|NCT04227405|147185710|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.38|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Supportive Dyadic Coping subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|||>.05
73819535|NCT04227405|147185710|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.3|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the common dyadic coping subscale||||>.05
73819536|NCT04227405|147185710|SUPERIORITY||Slope|1.21|STANDARD_ERROR_OF_MEAN|0.39|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Common Dyadic Coping subscale||||<.01
73819537|NCT04227405|147185710|SUPERIORITY||Slope|0.97|STANDARD_ERROR_OF_MEAN|0.47|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test for the Common Dyadic Coping Subscale||||<.10
73819538|NCT04227405|147185710|SUPERIORITY||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.37|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group in the Negative Dyadic Coping Subscale||||<.10
73819539|NCT04227405|147185710|SUPERIORITY||Slope|-1.14|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group for the Negative Dyadic Coping subscale||||<.05
73819540|NCT04227405|147185710|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.6|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test inn the Negative Dyadic Coping Scale||||>.05
73819541|NCT04227405|147185711|SUPERIORITY||Slope|0.57|STANDARD_ERROR_OF_MEAN|0.29|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the Supportive Dyadic Coping Subscale||||>.05
73819542|NCT04227405|147185711|SUPERIORITY||Slope|0.7|STANDARD_ERROR_OF_MEAN|0.37|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the intervention group for the Supportive Dyadic Coping Subscale||||<.05
73819543|NCT04227405|147185711|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.46|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up for the Supportive Dyadic Coping Subscale||||>.05
73819544|NCT04227405|147185713|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group in the Supportive Dyadic Coping Subcale||||>.05
73819545|NCT04227405|147185713|SUPERIORITY||Slope|1.45|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Supportive Dyadic Coping Scale||||<.001
73819546|NCT04227405|147185713|SUPERIORITY||Slope|1.42|STANDARD_ERROR_OF_MEAN|0.41|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||<.01
73819547|NCT04227405|147185713|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.35|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the Common Dyadic Coping Subscale||||>.05
73819548|NCT04227405|147185713|SUPERIORITY||Slope|2.12|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Common Dyadic Coping Subscale||||<.001
73819549|NCT04227405|147185713|SUPERIORITY||Slope|1.91|STANDARD_ERROR_OF_MEAN|0.55|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test inn the Common Dyadic Coping subscale||||<.01
73819550|NCT04227405|147185713|SUPERIORITY||Slope|-0.68|STANDARD_ERROR_OF_MEAN|0.42|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the Negative Dyadic Coping Scale||||>.05
73819551|NCT04227405|147185713|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.53|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group for the Negative Dyadic Coping Scale||||<.10
73819552|NCT04227405|147185713|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.65|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test for the Negative Dyadic Coping Subscale||||>.05
73819553|NCT02207400|147185742|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.612|||<|0.0001|TWO_SIDED|95.0|-13.191|-10.033|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.|||-10.033|-13.191|<0.0001
73819554|NCT02207400|147185743|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.652|||<|0.0001|TWO_SIDED|95.0|-0.738|-0.566|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.|||-0.566|-0.738|<0.0001
73819555|NCT03372382|147185749|EQUIVALENCE|We prespecified an equivalence margin of -10 to 10mm. We would consider non-opioid analgesia to be equivalent to opioid analgesia if the pain score mean difference between the groups and it's 95% confidence interval (CI) were within the prespecified margin. Pain score mean difference or 95% CI boundaries outside this range would be considered a clinically important difference between treatments|Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-2.1|11.9|||||The upper boundary of the CI is out of pre-specified limits.|Sample size calculations were based on VAS pain score at 2-4 weeks, assuming a mean of 10mm and standard deviation (SD) of 20 mm in the opioid group Assuming a two-sided alpha level of 0.05 and 80% power to detect equivalence, a total of 138 participants would be needed. To account for a 25% expected attrition rate and crossover, a total of 170 participants would be needed.||11.9|-2.1|
73819556|NCT02757352|147185751|SUPERIORITY||Odds Ratio (OR)|2.36||||0.009|TWO_SIDED|95.0|1.23|4.51|||Regression, Logistic|||||4.51|1.23|0.009
73819557|NCT02757352|147185751|SUPERIORITY||Odds Ratio (OR)|2.78||||0.002|TWO_SIDED|95.0|1.48|5.25|||Regression, Logistic|||||5.25|1.48|0.002
73819558|NCT02757352|147185752|SUPERIORITY||Odds Ratio (OR)|2.82||||0.004|TWO_SIDED|95.0|1.38|5.77|||Regression, Logistic|||||5.77|1.38|0.004
73819559|NCT02757352|147185752|SUPERIORITY||Odds Ratio (OR)|2.85||||0.004|TWO_SIDED|95.0|1.4|5.77|||Regression, Logistic|||||5.77|1.40|0.004
73819560|NCT02757352|147185753|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.81|-0.28|||Mixed Models Analysis|||||-0.28|-0.81|<0.001
73819561|NCT02757352|147185753|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.134|<|0.001|TWO_SIDED|95.0|-0.94|-0.41|||Mixed Models Analysis|||||-0.41|-0.94|<0.001
73819562|NCT02757352|147185754|SUPERIORITY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.179|<|0.001|TWO_SIDED|95.0|-0.96|-0.26|||Mixed Models Analysis|||||-0.26|-0.96|<0.001
73819563|NCT02757352|147185754|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||Mixed Models Analysis|||||-0.34|-1.05|<0.001
73819564|NCT02757352|147185756|SUPERIORITY||LS Mean Difference|2.8509|STANDARD_ERROR_OF_MEAN|1.139||0.013|TWO_SIDED|95.0|0.6092|5.0926|||Mixed Models Analysis|||||5.0926|0.6092|0.013
73819565|NCT02757352|147185756|SUPERIORITY||LS Mean Difference|2.7497|STANDARD_ERROR_OF_MEAN|1.1278||0.015|TWO_SIDED|95.0|0.5299|4.9694|||Mixed Models Analysis|||||4.9694|0.5299|0.015
73819566|NCT02757352|147185757|SUPERIORITY||LS Mean Difference|4.2001|STANDARD_ERROR_OF_MEAN|1.6467||0.012|TWO_SIDED|95.0|0.9525|7.4477|||Mixed Models Analysis|||||7.4477|0.9525|0.012
73819567|NCT02757352|147185757|SUPERIORITY||LS Mean Difference|4.6081|STANDARD_ERROR_OF_MEAN|1.6455||0.006|TWO_SIDED|95.0|1.3629|7.8533|||Mixed Models Analysis|||||7.8533|1.3629|0.006
73819568|NCT02757352|147185758|SUPERIORITY||Odds Ratio (OR)|2.73||||0.008|TWO_SIDED|95.0|1.3|5.76|||Regression, Logistic|||||5.76|1.30|0.008
73819569|NCT02757352|147185758|SUPERIORITY||Odds Ratio (OR)|3.43|||<|0.001|TWO_SIDED|95.0|1.66|7.08|||Regression, Logistic|||||7.08|1.66|<0.001
73819570|NCT02757352|147185759|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.02|10.41|||Regression, Logistic|||||10.41|2.02|<0.001
73819571|NCT02757352|147185759|SUPERIORITY||Odds Ratio (OR)|3.99|||<|0.001|TWO_SIDED|95.0|1.76|9.05|||Regression, Logistic|||||9.05|1.76|<0.001
73819572|NCT02757352|147185760|SUPERIORITY||LS Means Square Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.308||0.031|TWO_SIDED|95.0|-1.28|-0.06|||Mixed Models Analysis|||||-0.06|-1.28|0.031
73819573|NCT02757352|147185760|SUPERIORITY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.305||0.001|TWO_SIDED|95.0|-1.61|-0.41|||Mixed Models Analysis|||||-0.41|-1.61|0.001
73819574|NCT02757352|147185761|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.404||0.006|TWO_SIDED|95.0|-1.92|-0.33|||Mixed Models Analysis|||||-0.33|-1.92|0.006
73819575|NCT02757352|147185761|SUPERIORITY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.404||0.002|TWO_SIDED|95.0|-2.08|-0.49|||Mixed Models Analysis|||||-0.49|-2.08|0.002
73819576|NCT02757352|147185762|SUPERIORITY||LS Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|0.764|<|0.001|TWO_SIDED|95.0|-4.58|-1.57|||ANCOVA|||||-1.57|-4.58|<0.001
73819577|NCT02757352|147185762|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|0.751|<|0.001|TWO_SIDED|95.0|-5.68|-2.72|||ANCOVA|||||-2.72|-5.68|<0.001
73819578|NCT02757352|147185763|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.621||0.849|TWO_SIDED|95.0|-1.35|1.11|||Mixed Models Analysis|||||1.11|-1.35|0.849
73819579|NCT02757352|147185763|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.608||0.648|TWO_SIDED|95.0|-1.48|0.93|||Mixed Models Analysis|||||0.93|-1.48|0.648
73819580|NCT02757352|147185764|SUPERIORITY||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.443||0.018|TWO_SIDED|95.0|-1.93|-0.18|||Mixed Models Analysis|||||-0.18|-1.93|0.018
73819581|NCT02757352|147185764|SUPERIORITY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.442||0.008|TWO_SIDED|95.0|-2.05|-0.31|||Mixed Models Analysis|||||-0.31|-2.05|0.008
73819582|NCT02757352|147185765|SUPERIORITY||Odds Ratio (OR)|5.33||||0.0011|TWO_SIDED|96.0|1.47|19.4|||Regression, Logistic|||||19.40|1.47|0.0011
73819583|NCT02757352|147185765|SUPERIORITY||Odds Ratio (OR)|4.22||||0.031|TWO_SIDED|95.0|1.14|15.66|||Regression, Logistic|||||15.66|1.14|0.031
73819584|NCT02757352|147185766|SUPERIORITY||LS Mean Difference|-3.807|STANDARD_ERROR_OF_MEAN|2.8507||0.183|TWO_SIDED|95.0|-9.418|1.804|||Mixed Models Analysis|||||1.804|-9.418|0.183
73819585|NCT02757352|147185766|SUPERIORITY||LS Mean Difference|-2.743|STANDARD_ERROR_OF_MEAN|2.8202||0.331|TWO_SIDED|95.0|-8.294|2.807|||Mixed Models Analysis|||||2.807|-8.294|0.331
73819586|NCT02757352|147185767|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.148||0.008|TWO_SIDED|95.0|-0.69|-0.1|||Mixed Models Analysis|||||-0.10|-0.69|0.008
73819587|NCT02757352|147185767|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.148||0.038|TWO_SIDED|95.0|-0.6|-0.02|||Mixed Models Analysis|||||-0.02|-0.60|0.038
73819588|NCT02757352|147185768|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.325||0.871|TWO_SIDED|95.0|-0.59|0.7|||Mixed Models Analysis|||||0.70|-0.59|0.871
73819589|NCT02757352|147185768|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.327||0.295|TWO_SIDED|95.0|-0.3|0.99|||Mixed Models Analysis|||||0.99|-0.30|0.295
73819590|NCT02757352|147185769|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.406||0.257|TWO_SIDED|95.0|-1.26|0.34|||Mixed Models Analysis|||||0.34|-1.26|0.257
73819591|NCT02757352|147185769|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.402||0.057|TWO_SIDED|95.0|-1.56|0.02|||Mixed Models Analysis|||||0.02|-1.56|0.057
73819592|NCT02757352|147185770|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.496||0.082|TWO_SIDED|95.0|-1.85|0.11|||Mixed Models Analysis|||||0.11|-1.85|0.082
73819593|NCT02757352|147185770|SUPERIORITY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.493||0.088|TWO_SIDED|95.0|-1.82|0.13|||Mixed Models Analysis|||||0.13|-1.82|0.088
73819594|NCT02757352|147185771|SUPERIORITY||LS Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|1.442||0.219|TWO_SIDED|95.0|-4.66|1.09|||Mixed Models Analysis|||TJC||1.09|-4.66|0.219
73819595|NCT02757352|147185771|SUPERIORITY||LS Mean Difference|-3.53|STANDARD_ERROR_OF_MEAN|1.388||0.013|TWO_SIDED|95.0|-6.3|-0.76|||Mixed Models Analysis|||TJC||-0.76|-6.30|0.013
73819596|NCT02757352|147185771|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.355||0.009|TWO_SIDED|95.0|-1.68|-0.26|||Mixed Models Analysis|||SJC||-0.26|-1.68|0.009
73819597|NCT02757352|147185771|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.348||0.034|TWO_SIDED|95.0|-1.46|-0.06|||Mixed Models Analysis|||SJC||-0.06|-1.46|0.034
73819598|NCT02757352|147185773|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.5||0.325|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||||0.5|-1.5|0.325
73819599|NCT02757352|147185773|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.206|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||||0.4|-1.6|0.206
73819600|NCT02757352|147185774|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.601||0.33|TWO_SIDED|95.0|-1.77|0.6|||Mixed Models Analysis|||||0.60|-1.77|0.330
73819601|NCT02757352|147185774|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.602||0.11|TWO_SIDED|95.0|-2.15|0.22|||Mixed Models Analysis|||||0.22|-2.15|0.110
73819602|NCT02757352|147185775|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.81||0.348|TWO_SIDED|95.0|-2.4|0.8|||Mixed Models Analysis|||||0.8|-2.4|0.348
73819603|NCT02757352|147185775|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.82||0.386|TWO_SIDED|95.0|-2.3|0.9|||Mixed Models Analysis|||||0.9|-2.3|0.386
73819604|NCT02757352|147185776|SUPERIORITY||LS Mean Difference|-13.76|STANDARD_ERROR_OF_MEAN|4.835||0.005|TWO_SIDED|95.0|-23.32|-4.2|||ANCOVA|||Overall Impairment Score||-4.20|-23.32|0.005
73819605|NCT02757352|147185776|SUPERIORITY||LS Mean Difference|-6.29|STANDARD_ERROR_OF_MEAN|4.697||0.183|TWO_SIDED|95.0|-15.58|3.0|||ANCOVA|||Overall Impairment Score||3.00|-15.58|0.183
73819606|NCT02757352|147185776|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|3.114||0.06|TWO_SIDED|95.0|-12.05|0.26|||ANCOVA|||Percentage of absenteeism||0.26|-12.05|0.060
73819607|NCT02757352|147185776|SUPERIORITY||LS Mean Difference|-4.15|STANDARD_ERROR_OF_MEAN|3.098||0.182|TWO_SIDED|95.0|-10.27|1.97|||ANCOVA|||Percentage of absenteeism||1.97|-10.27|0.182
73819608|NCT02757352|147185776|SUPERIORITY||LS Mean Difference|-13.61|STANDARD_ERROR_OF_MEAN|4.558||0.003|TWO_SIDED|95.0|-22.62|-4.6|||ANCOVA|||Percentage of presentism||-4.60|-22.62|0.003
73819609|NCT02757352|147185776|SUPERIORITY||LS Mean Difference|-6.21|STANDARD_ERROR_OF_MEAN|4.446||0.164|TWO_SIDED|95.0|-15.0|2.58|||ANCOVA|||Percentage of presentism||2.58|-15.00|0.164
73819610|NCT02757352|147185776|SUPERIORITY||LS Mean Difference|-10.63|STANDARD_ERROR_OF_MEAN|3.669||0.004|TWO_SIDED|95.0|-17.85|-3.41|||LS Mean Difference|||Percentage of Impairment in Activities Performed Outside of Work||-3.41|-17.85|0.004
73819611|NCT02757352|147185776|SUPERIORITY||LS Mean Difference|-9.99|STANDARD_ERROR_OF_MEAN|3.621||0.006|TWO_SIDED|95.0|-17.12|-2.86|||ANCOVA|||Percentage of Impairment in Activities Performed Outside of Work||-2.86|-17.12|0.006
73819612|NCT02362425|147185780|SUPERIORITY|An a priori power calculation, with power at 80% and a two-sided α of 0·05, determined that n=76 participants (n=38 per group) would be required to detect a statistically significant post-intervention difference in plasma glutathione (GSH) concentration between NAC and placebo groups. After the primary endpoint was changed, re-evaluation of the sample size determined that a larger sample (total n=182) would be required. As per protocol, the study was completed at this time.|Mean Difference (Final Values)|0.1||||0.88|TWO_SIDED|95.0|-1.4|1.6|||Regression, Linear|Model comparing 12 m corrected 15-F2t-isoprostane conc. controlling for pre-intervention value. Investigated covariates: smoking and drinking status.||Null Hypothesis: In RYR1-RM myopathy patients, there will be no statistically significant difference in corrected 15-F2t-isoprostane concentration and/or corrected 15=f2t-Isop:PGR2alpha ratio between NAC and placebo groups at month 12, after controlling for established a priori confounders.||1.6|-1.4|0.88
73819613|NCT02362425|147185781|SUPERIORITY||Mean Difference (Final Values)|23.9||||0.11|TWO_SIDED|95.0|-5.5|53.4||Model controlled for six-month(pre-intervention) distance and treatment group. Investigated covariates: height|Regression, Linear|||In RYR1-RM myopathy patients, there will be no statistically significant difference in 6MWT (six minute walk test) total distance between NAC and placebo groups at month 12, after controlling for established a priori confounders.||53.4|-5.5|.11
73819614|NCT02362425|147185782|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.14|TWO_SIDED|95.0|-3.6|0.7|||Regression, Linear|||||0.7|-3.6|0.14
73819615|NCT02362425|147185783|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.62|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||||0.3|-0.5|0.62
73819616|NCT02362425|147185784|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.05|TWO_SIDED|95.0|-1.1|0.0|||t-test, 2 sided|||||0.0|-1.1|0.05
73819617|NCT02362425|147185785|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.25|TWO_SIDED|95.0|-2.1|0.6|||t-test, 2 sided|||||0.6|-2.1|0.25
73819618|NCT02362425|147185786|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.05|TWO_SIDED|95.0|-2.1|0.0|||t-test, 2 sided|||||0.0|-2.1|0.05
73819619|NCT02362425|147185787|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.09|TWO_SIDED|95.0|-0.6|7.3|||t-test, 2 sided|||||7.3|-0.6|0.09
73819620|NCT02362425|147185788|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.69|TWO_SIDED|95.0|-1.3|2.0|||t-test, 2 sided|||||2.0|-1.3|0.69
73819621|NCT02362425|147185789|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.31|TWO_SIDED|95.0|-3.5|1.1|||t-test, 2 sided|||||1.1|-3.5|0.31
73819622|NCT02362425|147185790|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.22|TWO_SIDED|95.0|-0.8|3.0|||t-test, 2 sided|||||3.0|-0.8|0.22
73819623|NCT02362425|147185791|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.93|TWO_SIDED|95.0|-2.6|2.4|||t-test, 2 sided|||||2.4|-2.6|0.93
73819624|NCT02362425|147185792|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.66|TWO_SIDED|95.0|-1.3|0.8|||t-test, 2 sided|||||0.8|-1.3|0.66
73819625|NCT02362425|147185793|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.09|TWO_SIDED|95.0|-0.4|4.6|||t-test, 2 sided|||||4.6|-0.4|0.09
73819626|NCT02362425|147185794|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.09|TWO_SIDED|95.0|-0.7|9.0|||t-test, 2 sided|||||9.0|-0.7|0.09
73819627|NCT02362425|147185795|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.15|TWO_SIDED|95.0|-13.4|2.4|||t-test, 2 sided|||||2.4|-13.4|0.15
73819628|NCT02362425|147185796|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.08|TWO_SIDED|95.0|-13.7|1.0|||t-test, 2 sided|||||1.0|-13.7|0.08
73819629|NCT02362425|147185797|SUPERIORITY||Mean Difference (Final Values)|-16.27||||0.39|TWO_SIDED|95.0|-80.1|47.5|||t-test, 2 sided|||||47.5|-80.1|0.39
73819630|NCT02362425|147185798|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.57|TWO_SIDED|95.0|-59.5|39.5|||t-test, 2 sided|||||39.5|-59.5|0.57
73819631|NCT02362425|147185799|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.12|TWO_SIDED|95.0|-5.0|0.6|||t-test, 2 sided|||||0.6|-5.0|0.12
73819632|NCT02362425|147185800|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.76|TWO_SIDED|95.0|-3.6|2.7|||t-test, 2 sided|||||2.7|-3.6|0.76
73819633|NCT02362425|147185801|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.72|TWO_SIDED|95.0|-2.5|3.5|||t-test, 2 sided|||||3.5|-2.5|0.72
73819634|NCT02362425|147185802|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.7|TWO_SIDED|95.0|-1.8|2.7|||t-test, 2 sided|||||2.7|-1.8|0.70
73819635|NCT02362425|147185803|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.88|TWO_SIDED|95.0|-2.8|3.3|||t-test, 2 sided|||||3.3|-2.8|0.88
73819636|NCT02362425|147185804|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.61|TWO_SIDED|95.0|-10.3|15.2|||t-test, 2 sided|||||15.2|-10.3|0.61
73819637|NCT02362425|147185805|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.87|TWO_SIDED|95.0|-7.4|8.5|||t-test, 2 sided|||||8.5|-7.4|0.87
73819638|NCT02362425|147185806|SUPERIORITY||Mean Difference (Final Values)|-12.5||||0.28|TWO_SIDED|95.0|-38.9|13.9|||t-test, 2 sided|||||13.9|-38.9|0.28
73819639|NCT00802672|147185845|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the primary efficacy analysis, a 90% confidence interval was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-0.20% to +0.20%)|Mean Difference (Final Values)|1.0|||||TWO_SIDED|90.0|-17.61|2.45|||Wald's method with Yates' continuity|||||2.45|-17.61|
73819640|NCT03026283|147185857|OTHER|||||||1||||||In order to evaluate the significance of sensitivity and specificity findings, we implement McNemar's test comparing sensitivity and specificity for CCTA alone and FFR-CT, assuming conditional dependence.|Chi-squared|||Reference test is positive (test of sensitivity).||||1.00
73819641|NCT03026283|147185857|OTHER||||||<|0.0047||||||In order to evaluate the significance of sensitivity and specificity findings, we implement Mcnemar's test comparing sensitive and pscificity for CCTA and FFR-CT assuming dependence.|Chi-squared|McNemar's chi-squared = 8.00||Reference test is Negative||||<0.0047
73819642|NCT03782571|147185864|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|99.1|-4.0|7.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 1 - Control|Testing equivalence with respect to microsphere clearance rate.||7.4|-4.0|
73819643|NCT03782571|147185864|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|3.01|||TWO_SIDED|99.1|-4.0|13.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Control|Testing equivalence with respect to microsphere clearance rate.||13.4|-4.0|
73819644|NCT03782571|147185864|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.2|STANDARD_ERROR_OF_MEAN|3.78|||TWO_SIDED|99.1|-2.7|19.1|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Control|Testing equivalence with respect to microsphere clearance rate.||19.1|-2.7|
73819645|NCT03782571|147185864|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|99.1|-2.6|15.5|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 1|Testing equivalence with respect to microsphere clearance rate.||15.5|-2.6|
73819646|NCT03782571|147185864|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|99.1|-2.0|8.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 2|Testing equivalence with respect to microsphere clearance rate.||8.9|-2.0|
73819647|NCT03782571|147185864|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|99.1|-4.3|10.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Test 1|Testing equivalence with respect to microsphere clearance rate.||10.3|-4.3|
73819648|NCT03782571|147185865|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|3.24|||TWO_SIDED|99.1|-1.0|17.8|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 1 - Control|Testing equivalence with respect to microsphere uptake rate.||17.8|-1.0|
73819649|NCT03782571|147185865|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|4.95|||TWO_SIDED|99.1|-7.8|20.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Control|Testing equivalence with respect to microsphere uptake rate.||20.9|-7.8|
73819650|NCT03782571|147185865|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|6.22|||TWO_SIDED|99.1|-15.1|20.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Control|Testing equivalence with respect to microsphere uptake rate.||20.9|-15.1|
73819651|NCT03782571|147185865|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|5.13|||TWO_SIDED|99.1|-20.4|9.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 1|Testing equivalence with respect to microsphere uptake rate.||9.4|-20.4|
73819652|NCT03782571|147185865|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|99.1|-12.6|5.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 2|Testing equivalence with respect to microsphere uptake rate.||5.3|-12.6|
73819653|NCT03782571|147185865|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|4.18|||TWO_SIDED|99.1|-13.9|10.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Test 1|Testing equivalence with respect to microsphere uptake rate.||10.3|-13.9|
73819654|NCT04656301|147185878|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|degrees of freedom = 1.92||||||<0.001
73819655|NCT00909220|147185944|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.06||0.05|TWO_SIDED|95.0|0.27|0.49|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-C score at week 0) to estimate depression at the end of treatment (IDS-C score at week 16).||0.49|0.27|0.05
73819656|NCT00909220|147185945|SUPERIORITY|ANCOVA|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|95.0|0.31|0.59|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-SR score at week 0) to estimate depression at the end of treatment (IDS-SR score at week 16).||0.59|0.31|<0.05
73819657|NCT00909220|147185946|OTHER|Multiple regression analyses|beta|0.43|STANDARD_ERROR_OF_MEAN|6.75||0.02|TWO_SIDED|||||p \<0.05 a priori threshold for statistical significance.|Regression, Linear|||||||.02
73896519|NCT00913458|147326256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.62|||<|0.0001|TWO_SIDED|95.0|-28.1|-11.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-11.1|-28.1|<0.0001
73896520|NCT00913458|147326256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.51||||0.0161|TWO_SIDED|95.0|-19.0|-2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-2.0|-19.0|0.0161
73896521|NCT02673541|147326376|OTHER|||||||1|||||||Fisher Exact|||||||1
73896522|NCT03456882|147326398|SUPERIORITY|||||||0.6346||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.6346
73819658|NCT00909220|147185947|OTHER|Hierarchical linear modeling (HLM) , an ordinary least square (OLS) regression-based analysis.|Slope|2.58|STANDARD_ERROR_OF_MEAN|0.75|<|0.05|TWO_SIDED|95.0|1.22|2.77||The variation of slopes among participants for each variable were calculated. If significant, a second level of analysis focused on predictors of the variation was conducted.|Regression, Logistic|df = 31||A two-level hierarchical linear model assessing the effects of negativity bias and positivity offset at pre-treatment on the rate of depression severity (IDS-SR) over 16 weeks of treatment (time). First level units were 'weeks in BA treatment', with participants limited to those who attended five or more therapy sessions, resulting in a total of 421 treatment weeks for analysis. Second-level units were the 'subjects entering BA treatment'.||2.77|1.22|<0.05
73819659|NCT04957212|147185992|EQUIVALENCE|We used an equivalence margin of 0.2 for the primary endpoint.|Risk Difference (RD)|-0.04||||0.54|TWO_SIDED|95.0|-0.16|0.09|||Chi-squared|||||0.09|-0.16|0.54
73819660|NCT04957212|147185993|OTHER||Risk Difference (RD)|-0.07||||0.26|TWO_SIDED|95.0|-0.21|0.06|||Chi-squared|||||0.06|-0.21|0.26
73819661|NCT04957212|147185994|OTHER|||||||0.99|||||||Fisher Exact|||||||0.99
73819662|NCT04957212|147185995|OTHER|||||||0.56|||||||Chi-squared|||||||0.56
73819663|NCT03224624|147186033|EQUIVALENCE|Comparing baseline-\>12month SBP change (mean difference) between the two groups.|Mean Difference (Net)|-1.35|STANDARD_ERROR_OF_MEAN|3.8||0.72|TWO_SIDED|||||p\<0.05 considered significant.|t-test, 2 sided||direction of comparison: (self-management change over 12 months) - (usual care change over 12 months) in SBP|t- tests were done to compare group mean differences between self-management and usual care and within groups Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.||||0.72
73819664|NCT03224624|147186033|EQUIVALENCE|Comparing baseline-\>12month DBP change (mean difference) between the two groups.|Mean Difference (Net)|-3.75|STANDARD_ERROR_OF_MEAN|2.55||0.15|TWO_SIDED||||||t-test, 2 sided||direction of comparison: (self-management change over 12 months) - (usual care change over 12 months) in DBP|Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.||||0.15
73819665|NCT03224624|147186033|EQUIVALENCE|Comparing baseline-\>12month SBP change within self-management group (null hypothesis no change).|Mean Difference (Net)|-6.95||||0.01|TWO_SIDED||||||t-test, 2 sided||(12-month SBP)-(baseline SBP) for self-management group (as given in table)|change in SBP from baseline to 12-months within self-management group.||||0.01
73819666|NCT03224624|147186033|EQUIVALENCE|Comparing baseline-\>12month SBP change within usual care group (null hypothesis no change).|Mean Difference (Net)|-5.59|||<|0.05|TWO_SIDED||||||t-test, 2 sided||(12-month SBP)-(baseline SBP) for usual care group (as given in table)|Comparing baseline-\>12month SBP change within usual care group.||||<0.05
73819667|NCT03224624|147186033|EQUIVALENCE|Comparing baseline-\>12month DBP change within self-management group (null hypothesis no change).|Mean Difference (Net)|-5.51|||<|0.01|TWO_SIDED||||||t-test, 2 sided||(12-month DBP)-(baseline DBP) for self-management group (as given in table)|change in DBP from baseline to 12-months within self-management group.||||<0.01
73819668|NCT03224624|147186033|EQUIVALENCE|change in DBP from baseline to 12-months within usual care group.|Mean Difference (Net)|-1.76||||0.34|TWO_SIDED||||||t-test, 2 sided||(12-month DBP)-(baseline DBP) for usual care group (as given in table)|||||0.34
73819669|NCT01884545|147186036|SUPERIORITY|||||||0.1073|||||||Regression, Linear|||||||0.1073
73819670|NCT01884545|147186036|SUPERIORITY|||||||0.0615|||||||Regression, Linear|||||||0.0615
73819671|NCT01884545|147186037|SUPERIORITY|||||||0.6732|||||||Regression, Linear|||||||0.6732
73819672|NCT01884545|147186037|SUPERIORITY|||||||0.3754|||||||Regression, Linear|||||||0.3754
73819673|NCT01884545|147186038|SUPERIORITY||Odds Ratio (OR)|2.853||||0.0073|TWO_SIDED|95.0|1.326|6.139|||Regression, Logistic|||||6.139|1.326|0.0073
73819674|NCT01884545|147186038|SUPERIORITY||Odds Ratio (OR)|1.045||||0.9068|TWO_SIDED|95.0|0.5|2.183|||Regression, Logistic|||||2.183|0.5|0.9068
73819675|NCT01884545|147186039|SUPERIORITY||Odds Ratio (OR)|1.333||||0.7822|TWO_SIDED|95.0|0.173|10.254|||Regression, Logistic|||||10.254|0.173|0.7822
73819676|NCT01884545|147186039|SUPERIORITY||Odds Ratio (OR)|1.333||||0.7822|TWO_SIDED|95.0|0.173|10.254|||Regression, Logistic|||||10.254|0.173|0.7822
73819677|NCT01884545|147186040|SUPERIORITY|||||||0.7985|||||||Regression, Linear|||||||0.7985
73819678|NCT01884545|147186040|SUPERIORITY|||||||0.1642|||||||Regression, Linear|||||||0.1642
73819679|NCT01884545|147186041|SUPERIORITY|||||||0.8027|||||||Regression, Linear|||||||0.8027
73819680|NCT01884545|147186041|SUPERIORITY|||||||0.7751|||||||Regression, Linear|||||||0.7751
73819681|NCT01884545|147186042|SUPERIORITY|||||||0.5557|||||||Regression, Linear|||||||0.5557
73819682|NCT01884545|147186042|SUPERIORITY|||||||0.7834|||||||Regression, Linear|||||||0.7834
73819683|NCT01884545|147186043|SUPERIORITY|||||||0.1439|||||||Regression, Linear|||||||0.1439
73819684|NCT01884545|147186043|SUPERIORITY|||||||0.2275|||||||Regression, Linear|||||||0.2275
73819685|NCT01884545|147186044|SUPERIORITY|||||||0.7639|||||||Regression, Linear|||||||0.7639
73819686|NCT01884545|147186044|SUPERIORITY|||||||0.9999|||||||Regression, Linear|||||||0.9999
73819687|NCT01884545|147186045|SUPERIORITY|||||||0.4673|||||||Regression, Linear|||||||0.4673
73819688|NCT01884545|147186045|SUPERIORITY|||||||0.2297|||||||Regression, Linear|||||||0.2297
73819689|NCT01884545|147186046|SUPERIORITY|||||||0.2192|||||||Regression, Linear|||||||0.2192
73819690|NCT01884545|147186046|SUPERIORITY|||||||0.9062|||||||Regression, Linear|||||||0.9062
73819691|NCT01884545|147186047|SUPERIORITY|||||||0.1466|||||||Regression, Linear|||||||0.1466
73819692|NCT01884545|147186047|SUPERIORITY|||||||0.207|||||||Regression, Linear|||||||0.2070
73819693|NCT01884545|147186048|SUPERIORITY|||||||0.6289|||||||Regression, Linear|||||||0.6289
73819694|NCT01884545|147186048|SUPERIORITY|||||||0.9631|||||||Regression, Linear|||||||0.9631
73819695|NCT01884545|147186049|SUPERIORITY|||||||0.2313|||||||Regression, Linear|||||||0.2313
73819696|NCT01884545|147186049|SUPERIORITY|||||||0.8029|||||||Regression, Linear|||||||0.8029
73819697|NCT01884545|147186050|SUPERIORITY|||||||0.071|||||||Regression, Linear|||||||0.0710
73819698|NCT01884545|147186050|SUPERIORITY|||||||0.8069|||||||Regression, Linear|||||||0.8069
73819699|NCT01884545|147186051|SUPERIORITY|||||||0.0512|||||||Chi-squared|||||||0.0512
73819700|NCT01884545|147186051|SUPERIORITY|||||||0.4478|||||||Chi-squared|||||||0.4478
73819701|NCT01884545|147186054|SUPERIORITY|||||||0.7923|||||||Regression, Linear|||Perceived Risk for CHD, Consequences subscale||||0.7923
73819702|NCT01884545|147186054|SUPERIORITY|||||||0.0636|||||||Regression, Linear|||Perceived Risk for CHD, Personal control||||0.0636
73819703|NCT01884545|147186054|SUPERIORITY|||||||0.2063|||||||Regression, Linear|||Perceived Risk for CHD, Treatment control||||0.2063
73819704|NCT01884545|147186054|SUPERIORITY|||||||0.2529|||||||Regression, Linear|||Perceived Risk for CHD, Emotional representations||||0.2529
73819705|NCT01884545|147186054|SUPERIORITY|||||||0.1085|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), Consequences subscale||||0.1085
73819706|NCT01884545|147186054|SUPERIORITY|||||||0.337|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), personal control subscale||||0.3370
73819707|NCT01884545|147186054|SUPERIORITY|||||||0.3483|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), treatment control subscale||||0.3483
73819708|NCT01884545|147186054|SUPERIORITY|||||||0.5384|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), emotional representations||||0.5384
73819709|NCT01884545|147186055|SUPERIORITY|||||||0.7447|||||||Regression, Linear|||Perceived Risk for T2D, Consequences subscale||||0.7447
73819710|NCT01884545|147186055|SUPERIORITY|||||||0.6378|||||||Regression, Linear|||Perceived Risk for T2D, Personal control||||0.6378
73819711|NCT01884545|147186055|SUPERIORITY|||||||0.3209|||||||Regression, Linear|||Perceived Risk for T2D, Treatment control||||0.3209
73819712|NCT01884545|147186055|SUPERIORITY|||||||0.0058|||||||Regression, Linear|||Perceived Risk for T2D, Emotional representations||||0.0058
73819713|NCT01884545|147186055|SUPERIORITY|||||||0.3769|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), Consequences subscale||||0.3769
73819714|NCT01884545|147186055|SUPERIORITY|||||||0.0872|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), personal control||||0.0872
73819715|NCT01884545|147186055|SUPERIORITY|||||||0.4302|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), treatment control||||0.4302
73819716|NCT01884545|147186055|SUPERIORITY|||||||0.4133|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), emotional representations||||0.4133
73819717|NCT01884545|147186056|SUPERIORITY|||||||0.3106|||||||Regression, Linear|||||||0.3106
73819718|NCT01884545|147186056|SUPERIORITY|||||||0.7087|||||||Regression, Linear|||||||0.7087
73819719|NCT01884545|147186057|SUPERIORITY||Odds Ratio (OR)|1.034||||0.9259|TWO_SIDED|95.0|0.511|2.094|||Regression, Logistic|||Stages of Change, Weight reduction||2.094|0.511|0.9259
73819720|NCT01884545|147186057|SUPERIORITY||Odds Ratio (OR)|2.252||||0.0082|TWO_SIDED|95.0|1.234|4.111|||Regression, Logistic|||Stages of Change, Exercise behavior||4.111|1.234|0.0082
73819721|NCT01884545|147186057|SUPERIORITY||Odds Ratio (OR)|0.423||||0.2954|TWO_SIDED|95.0|0.084|2.12|||Regression, Logistic|||Stages of Change, Smoking behavior||2.120|0.084|0.2954
73819722|NCT01884545|147186057|SUPERIORITY||Odds Ratio (OR)|1.216||||0.5669|TWO_SIDED|95.0|0.622|2.376|||Regression, Logistic|||Stages of Change, Healthier eating behavior||2.376|0.622|0.5669
73819723|NCT01884545|147186057|SUPERIORITY||Odds Ratio (OR)|0.622||||0.121|TWO_SIDED|95.0|0.341|1.134|||Regression, Logistic|||Stages of Change, Stress behavior||1.134|0.341|0.1210
73819724|NCT01884545|147186057|SUPERIORITY||Odds Ratio (OR)|0.928||||0.8355|TWO_SIDED|95.0|0.461|1.872|||Regression, Logistic|||Weight reduction||1.872|0.461|0.8355
73819725|NCT01884545|147186057|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0459|TWO_SIDED|95.0|1.011|3.311|||Regression, Logistic|||Exercise behavior||3.311|1.011|0.0459
73819726|NCT01884545|147186057|SUPERIORITY||Odds Ratio (OR)|0.563||||0.465|TWO_SIDED|95.0|0.121|2.629|||Regression, Logistic|||Smoking behavior||2.629|0.121|0.4650
73819727|NCT01884545|147186057|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8303|TWO_SIDED|95.0|0.478|1.808|||Regression, Logistic|||Healthier eating behavior||1.808|0.478|0.8303
73819728|NCT01884545|147186057|SUPERIORITY||Odds Ratio (OR)|1.347||||0.3254|TWO_SIDED|95.0|0.744|2.439|||Regression, Logistic|||Stress behavior||2.439|0.744|0.3254
73819729|NCT01884545|147186058|SUPERIORITY|||||||0.0174|||||||Regression, Linear|||||||0.0174
73819730|NCT01884545|147186058|SUPERIORITY|||||||0.8694|||||||Regression, Linear|||||||0.8694
73819731|NCT01884545|147186059|SUPERIORITY|||||||0.4768|||||||Regression, Linear|||||||0.4768
73819732|NCT01884545|147186059|SUPERIORITY|||||||0.8452|||||||Regression, Linear|||||||0.8452
73819733|NCT01884545|147186060|SUPERIORITY||Odds Ratio (OR)|1.591||||0.5589|TWO_SIDED|95.0|0.335|7.544|||Regression, Logistic|||||7.544|0.335|0.5589
73819734|NCT01188668|147186076|SUPERIORITY_OR_OTHER||ratio of adjusted means|105.97|||||TWO_SIDED|90.0|101.39|110.76|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||110.76|101.39|
73819735|NCT01188668|147186077|SUPERIORITY_OR_OTHER||ratio of adjusted means|101.05|||||TWO_SIDED|90.0|92.94|109.87|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||109.87|92.94|
73819736|NCT01188668|147186082|SUPERIORITY_OR_OTHER||ratio of adjusted means|102.93|||||TWO_SIDED|90.0|94.21|112.46|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||112.46|94.21|
73819737|NCT01188668|147186083|SUPERIORITY_OR_OTHER||ratio of adjusted means|106.27|||||TWO_SIDED|90.0|100.97|111.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||111.85|100.97|
73819738|NCT02937636|147186107|OTHER||Least square (LS) mean difference|-0.09|||<|0.0001|TWO_SIDED|95.0|-0.12|-0.07|||ANCOVA|From ANCOVA with treatment, gender, smoking status and baseline MGI stratification as factors and baseline as covariate.|Difference is the first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.07|-0.12|<.0001
73819739|NCT00583011|147186116|EQUIVALENCE||Median Difference (Final Values)|0.02|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73819740|NCT02453256|147186170|SUPERIORITY||Difference in least square means|-1.73||||0.0983|TWO_SIDED|95.0|-3.78|0.32|||Repeated Measure|||Difference in least square means between the TCZ group and the Placebo group at week 48. Null hypothesis: There is no difference between the TCZ group and the placebo group in mean change in mRSS from baseline to Week 48.||0.32|-3.78|0.0983
73819741|NCT02453256|147186171|SUPERIORITY||Weighted difference|21.91||||0.0007|TWO_SIDED|95.0|9.2|34.6|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 20% improvement in mRSS.||34.6|9.2|0.0007
73819742|NCT02453256|147186171|SUPERIORITY||Weighted difference|4.32||||0.5139|TWO_SIDED|95.0|-8.7|17.3|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 40% improvement in mRSS.||17.3|-8.7|0.5139
73819743|NCT02453256|147186171|SUPERIORITY||Weighted difference|-5.41||||0.3276|TWO_SIDED|95.0|-16.2|5.4|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 60% improvement in mRSS.||5.4|-16.2|0.3276
73819744|NCT02453256|147186172|SUPERIORITY|||||||0.0015||||||P-value from Van Elteren analysis stratified by IL-6 level (\<10; \>=10 pg/mL) at screening.|Van Elteren|||||||0.0015
73819745|NCT02453256|147186173|SUPERIORITY||Difference in least square means|0.167||||0.0001|TWO_SIDED|95.0|0.083|0.25|||Repeated Measure|||||0.250|0.083|0.0001
73819746|NCT02453256|147186174|SUPERIORITY||Difference in least square means|-0.053||||0.4489|TWO_SIDED|95.0|-0.192|0.085|||Repeated Measure|||||0.085|-0.192|0.4489
73819747|NCT02453256|147186175|SUPERIORITY||Difference in least square means|-2.44||||0.4339|TWO_SIDED|95.0|-8.57|3.7|||Repeated Measure|||||3.70|-8.57|0.4339
73819748|NCT02453256|147186176|SUPERIORITY||Difference in least square means|-2.46||||0.4378|TWO_SIDED|95.0|-8.72|3.79|||Repeated Measure|||||3.79|-8.72|0.4378
73819749|NCT02453256|147186177|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0821|TWO_SIDED|95.0|0.37|1.06|||Cox-proportional hazards model|||||1.06|0.37|0.0821
73819750|NCT01237327|147186231|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7799||||0.3348|TWO_SIDED|95.0|0.47|1.294|||Log Rank|||Overall survival compared using the hazard ratio; hazard ratio \<1.0 is in favor of exemestane.||1.294|0.47|0.3348
73819751|NCT04811664|147186255|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|52.6|||||TWO_SIDED|95.0|-14.1|80.3|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||80.3|-14.1|
73819752|NCT04811664|147186258|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|71.0|||||TWO_SIDED|95.0|-9.5|92.3|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||92.3|-9.5|
73819753|NCT04811664|147186259|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|41.2|||||TWO_SIDED|95.0|-37.7|74.9|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||74.9|-37.7|
73819754|NCT05052697|147186314|OTHER||Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.34|2.2|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: A1||2.20|0.34|
73819755|NCT05052697|147186314|OTHER||Geometric Mean Ratio|1.53|||||TWO_SIDED|95.0|0.86|2.7|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: A2||2.70|0.86|
73819756|NCT05052697|147186314|OTHER||Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.4|2.28|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: B1||2.28|0.40|
73819757|NCT05052697|147186314|OTHER||Geometric Mean Ratio|0.54|||||TWO_SIDED|95.0|0.25|1.18|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: B2||1.18|0.25|
73819758|NCT05052697|147186315|OTHER||Difference in percentage of participants|26.2|||||TWO_SIDED|95.0|-4.5|53.5|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: A1||53.5|-4.5|
73819759|NCT05052697|147186315|OTHER||Difference in percentage of participants|17.1|||||TWO_SIDED|95.0|-19.2|49.4|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: A2||49.4|-19.2|
73819760|NCT05052697|147186315|OTHER||Difference in percentage of participants|-12.4|||||TWO_SIDED|95.0|-41.7|19.1|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: B1||19.1|-41.7|
73819761|NCT05052697|147186315|OTHER||Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-29.2|32.5|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: B2||32.5|-29.2|
73819762|NCT01289574|147186334|SUPERIORITY_OR_OTHER|||||||0.1919|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) row mean score statistics, adjusting for investigational site||||||0.1919
73819763|NCT01289574|147186335|SUPERIORITY_OR_OTHER|||||||0.061|||||||Cochran-Mantel-Haenszel|||||||0.0610
73819764|NCT01289574|147186336|SUPERIORITY_OR_OTHER|||||||0.0857|||||||Cochran-Mantel-Haenszel|||||||0.0857
73819765|NCT01554163|147186360|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the betweentreatment difference in LS mean time-weighted average change from baseline over 12 weeks in WOMAC Pain Subscale (VAS) is no greater than 10 mm (non-inferiority margin).|Difference in LS Mean Change|-1.63||||0.39|TWO_SIDED|95.0|-5.37|2.1|||ANCOVA|||||2.10|-5.37|0.390
73819766|NCT01554163|147186361|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.32||||0.464|TWO_SIDED|95.0|-4.88|2.23|||ANCOVA|||||2.23|-4.88|0.464
73819767|NCT01554163|147186362|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.09||||0.624|TWO_SIDED|95.0|-5.48|3.3|||ANCOVA|||||3.30|-5.48|0.624
73819768|NCT01554163|147186363|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.08||||0.369|TWO_SIDED|95.0|-0.26|0.1|||ANCOVA|||||0.10|-0.26|0.369
73819769|NCT01554163|147186364|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.09||||0.294|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||||0.08|-0.25|0.294
73819770|NCT01554163|147186365|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.86||||0.679|TWO_SIDED|95.0|-4.96|3.24|||ANCOVA|||||3.24|-4.96|0.679
73819771|NCT01554163|147186366|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.1||||0.314|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.10|-0.30|0.314
73819772|NCT01037816|147186374|SUPERIORITY|||||||0.137|||||||ANCOVA|||The treatment effect of the FS-67 patch was estimated by computing the difference in LS means of the FS-67 and placebo patches from the ANCOVA model||||0.137
73819773|NCT01037816|147186375|SUPERIORITY|||||||0.044|||||||ANCOVA|||||||0.044
73819774|NCT01972464|147186380|SUPERIORITY||Odds Ratio (OR)|1.77||||0.39|TWO_SIDED|95.0|0.48|6.52||a priori threshold for statistical significance = 0.05|Regression, Logistic|adjusted for age (18-25 years versus \>25 years) and pre-quit smoking level (\<10 versus \>10 cigarettes per day)|OR represents of odds of abstinence in progesterone group versus placebo group|Null hypothesis- odds of week 8 point prevalence abstinence were equal between placebo and progesterone group.||6.52|0.48|0.39
73819775|NCT01972464|147186381|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.41|TWO_SIDED|95.0|0.66|3.38||a priori threshold = 0.05|Regression, Cox|Adjusted for age and pre-quit smoking level|Hazard ratio is placebo / progesterone|||3.38|0.66|0.41
73819776|NCT01972464|147186382|SUPERIORITY||Risk Ratio (RR)|0.91|||<|0.001|TWO_SIDED|95.0|0.86|0.96|||general estimating equation|adjusted for age \& pre-quit smoking level; specified a gamma distribution, log link, autoregressive correlation structure|risk ratio is progesterone versus placebo|null hypothesis rate of change in QSU-brief scores were equal between treatment groups||0.96|0.86|<0.001
73819777|NCT02526160|147186383|SUPERIORITY||||||<|0.0001||||||From Cochran-Mantel-Haenszel (CMH) testing for association between achieving mean serum phosphorus levels above lower limit of normal (LLN) and treatment group, adjusting for stratification of Brief Pain Inventory (BPI) Average Pain and region.|Cochran-Mantel-Haenszel|||||||< 0.0001
73819778|NCT02526160|147186384|SUPERIORITY||Least squares (LS) mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.275||0.0919|TWO_SIDED|95.0|-1.0|0.08||Prespecified significance level for test after Hochberg adjustment: 0.05|GEE model|||||0.08|-1.00|0.0919
73819779|NCT02526160|147186385|SUPERIORITY||LS mean difference|-8.31|STANDARD_ERROR_OF_MEAN|3.251||0.0106|TWO_SIDED|95.0|-14.68|-1.94||Prespecified significance level for test after Hochberg adjustment: 0.0167|GEE model|||||-1.94|-14.68|0.0106
73819780|NCT02526160|147186386|SUPERIORITY||LS mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.479||0.0478|TWO_SIDED|95.0|-9.76|-0.05||Prespecified significance level for test after Hochberg adjustment: 0.025|GEE model|||||-0.05|-9.76|0.0478
73819781|NCT01048944|147186417|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values are adjusted for multiple comparisons except for specific a priori directional predictions.|Mixed Models Analysis|||Mixed-model repeated measures multivariate analyses of variance assessed Treatment x Day of abstinence (days 3, 24, 45, and 66) based on changes from pre-quit baseline to values of the four post-quit time points (days 3, 24, 45, and 66).||||<0.05
73819782|NCT01133704|147186422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.719|TWO_SIDED|95.0|0.69|1.7|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable, stratified by bisphosphonate use (placebo/sipuleucel-T)|||1.70|0.69|0.719
73819783|NCT01133704|147186423|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.331|TWO_SIDED|95.0|0.78|2.07|||Log Rank||Obtained from a Cox proportional hazards model with treatment as the independent variable, and stratified by bisphosphonate use (placebo/sipuleucel-T).|||2.07|0.78|0.331
73819784|NCT00136214|147186424|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.08
73819785|NCT00136214|147186424|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Mi/Cr at time points 1,2 and 3||||0.3
73819786|NCT00136214|147186424|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.9
73819787|NCT00136214|147186424|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.7
73819788|NCT00136214|147186424|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1,2 and 3||||0.4
73819789|NCT00136214|147186424|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.6
73819790|NCT00136214|147186424|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.3
73819791|NCT00136214|147186424|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy ofMI/Cr at time points 1,2 and 3||||0.3
73819792|NCT00136214|147186424|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.3
73819793|NCT00136214|147186424|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.4
73819794|NCT00136214|147186424|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.9
73819795|NCT00136214|147186424|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2||||0.6
73819796|NCT00136214|147186424|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.7
73819797|NCT00136214|147186424|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.1
73819798|NCT00136214|147186424|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2||||0.6
73819799|NCT00136214|147186424|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.5
73819800|NCT00136214|147186424|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.4
73819801|NCT00136214|147186424|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Crat time points 1 and 2||||0.9
73819802|NCT00136214|147186425|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for HVLT||||>0.05
73819803|NCT00136214|147186425|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for ROCF||||< 0.05
73819804|NCT00136214|147186425|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for HVLT||||>0.05
73819805|NCT00136214|147186425|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for ROCF||||>0.05
73819806|NCT04985942|147186429|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|-6.38|-3.44|||Mixed Effects Model for Repeated Measure|MMRM Analysis Based on Hypothetical Estimand Strategy||||-3.44|-6.38|<0.0001
73819807|NCT04985942|147186430|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.85|-0.48|||Mixed Effects Model for Repeated Measure|MMRM Analysis Based on Hypothetical Estimand Strategy||||-0.48|-0.85|<0.0001
73819808|NCT02849704|147186478|SUPERIORITY||||||<|0.001||||||a priori threshold for significance: \<0.05|t-test, 2 sided|||||||<0.001
73819809|NCT02849704|147186479|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
73819810|NCT02849704|147186480|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||<0.01
73819811|NCT02849704|147186481|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
73819812|NCT02849704|147186482|SUPERIORITY||||||<|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||<0.05
73819813|NCT02849704|147186483|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
73819814|NCT02576977|147186493|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.99324|TWO_SIDED|95.0|1.08|2.08|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).|||2.08|1.08|0.99324
73819815|NCT02576977|147186494|SUPERIORITY||Hazard Ratio (HR)|1.84||||0.99989|TWO_SIDED|95.0|1.32|2.55|||Log Rank|One-sided p-value based on Stratified log-rank test.|||The Hazard Ratio and 95% confidence intervals were based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).|2.55|1.32|0.99989
73819816|NCT02576977|147186495|SUPERIORITY||Difference in % vs. SOC|-5.2||||0.79921|TWO_SIDED|95.0|-17.1|6.9|||Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.|6.9|-17.1|0.79921
73819817|NCT01128400|147186517|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
73819818|NCT01128400|147186518|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
73819819|NCT04304508|147186529|OTHER|Dose-response test by using multiple comparison procedures (MCP) Mod.||||||0.7976|||||||MCP Mod|||Dose-response test||||0.7976
73819820|NCT04304508|147186529|OTHER||Crude incidence ratio|1.044|||||TWO_SIDED|90.0|0.8105|1.3478||||||Comparison of the Asundexian 10 mg group versus Placebo group.||1.3478|0.8105|
73819821|NCT04304508|147186529|OTHER||Crude incidence ratio|1.1963|||||TWO_SIDED|90.0|0.9281|1.5428||||||Comparison of the Asundexian 20 mg group versus Placebo group.||1.5428|0.9281|
73819822|NCT04304508|147186529|OTHER||Crude incidence ratio|1.0485|||||TWO_SIDED|90.0|0.8082|1.3619||||||Comparison of the Asundexian 50 mg group versus Placebo group.||1.3619|0.8082|
73819823|NCT04304508|147186537|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.724|||=|0.1507|TWO_SIDED|90.0|0.924|3.215|||Log Rank|||Comparison of the Asundexian 10 mg group versus Placebo group||3.215|0.924|= 0.1507
73819824|NCT04304508|147186537|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.285|||=|0.5339|TWO_SIDED|90.0|0.662|2.494|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||2.494|0.662|= 0.5339
73819825|NCT04304508|147186537|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.749|||=|0.1401|TWO_SIDED|90.0|0.938|3.262|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||3.262|0.938|= 0.1401
73819826|NCT04304508|147186537|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.585|||=|0.1653|TWO_SIDED|90.0|0.918|2.736|||Log Rank|||Comparison of the Total Asundexian group versus Placebo group||2.736|0.918|= 0.1653
73819827|NCT02688764|147186543|SUPERIORITY|||||||0.1465||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.1465
73819828|NCT02688764|147186546|SUPERIORITY|||||||0.0872||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects||||0.0872
73819829|NCT02688764|147186547|SUPERIORITY|||||||0.6207||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.6207
73819830|NCT02688764|147186547|SUPERIORITY|||||||0.3226||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.3226
73819831|NCT02688764|147186565|SUPERIORITY|||||||0.5682||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=2 years to \<6 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.5682
73819832|NCT02688764|147186565|SUPERIORITY|||||||0.2271||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=6 years to \<12 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.2271
73819833|NCT02688764|147186565|SUPERIORITY|||||||0.022||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=12 years to \<=18 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.0220
73819834|NCT02688764|147186566|SUPERIORITY|||||||0.0058||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline above Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.0058
73819835|NCT02688764|147186566|SUPERIORITY|||||||0.5801||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline below or within Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.5801
73819836|NCT00885378|147186570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.51|STANDARD_ERROR_OF_MEAN|6.162||0.1248|TWO_SIDED|95.0|-21.68|2.66|||ANCOVA|ANCOVA model: post - pre = pretreatment.|Estimate = adjusted mean change for Saxagliptin - adjusted mean change for Placebo.|||2.66|-21.68|0.1248
73819837|NCT00885378|147186571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|||||TWO_SIDED|95.0|1.1|25.4|||||Adjusted for baseline.|||25.4|1.1|
73819838|NCT00885378|147186572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|||||TWO_SIDED|95.0|3.0|24.7|||||Adjusted for baseline.|||24.7|3.0|
73819839|NCT00885378|147186579|SUPERIORITY_OR_OTHER||Standard Error of the Mean|-0.34||||0.0063|TWO_SIDED|95.0|-0.58|-0.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo at Week 12(LOCF) was adjusted for baseline.|difference between week t value - baseline value = baseline value + treatment.|||-0.10|-0.58|0.0063
73819840|NCT02579382|147186610|SUPERIORITY||Least Squares Mean Difference|0.107||||0.227|TWO_SIDED|95.0|-0.067|0.282||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.282|-0.067|0.227
73819841|NCT02579382|147186610|SUPERIORITY||Least Squares Mean Difference|0.018||||0.84|TWO_SIDED|95.0|-0.156|0.191||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.191|-0.156|0.840
73819842|NCT02579382|147186610|SUPERIORITY||Least Squares Mean Difference|0.127||||0.151|TWO_SIDED|95.0|-0.047|0.301||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.301|-0.047|0.151
73819843|NCT05725824|147186641|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
73819844|NCT05725824|147186642|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
73819845|NCT05725824|147186643|SUPERIORITY||||||<|0.05||||||Arms/Groups were collapsed for RM-ANOVA to compare between various earmold types. A post-hoc paired t-test w/ Bonferroni correction was utilized to compare ear mold material types.|Repeated Measure Analysis of Variance|||||||<0.05
73819846|NCT05725824|147186644|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
73819847|NCT03252145|147186686|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
73819848|NCT03252145|147186687|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
73819849|NCT03252145|147186688|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
73819850|NCT03252145|147186689|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
73819851|NCT03252145|147186690|OTHER|||||||0.552|||||||t-test, 2 sided|||||||0.552
73819852|NCT03252145|147186691|OTHER|||||||0.498|||||||t-test, 2 sided|||||||0.498
73819853|NCT03252145|147186692|OTHER|||||||0.264|||||||t-test, 2 sided|||Affected Arm Only||||0.264
73819854|NCT03252145|147186692|OTHER|||||||0.224|||||||t-test, 2 sided|||Unaffected arm||||0.224
73819855|NCT03252145|147186693|OTHER|||||||0.125|||||||t-test, 2 sided|||Affected arm||||0.125
73819856|NCT03252145|147186693|OTHER|||||||0.241|||||||t-test, 2 sided|||Unaffected arm||||0.241
73819857|NCT03252145|147186694|OTHER|||||||0.261|||||||t-test, 2 sided|||Affected Arm||||0.261
73819858|NCT03252145|147186694|OTHER|||||||0.597|||||||t-test, 2 sided|||Unaffected Arm||||0.597
73819859|NCT03252145|147186695|OTHER|||||||0.596|||||||t-test, 2 sided|||Affected arm||||0.596
73819860|NCT03252145|147186695|OTHER|||||||0.219|||||||t-test, 2 sided|||Unaffected arm||||0.219
73819861|NCT03252145|147186696|OTHER|||||||0.842|||||||t-test, 2 sided|||||||0.842
73819862|NCT03252145|147186697|OTHER|||||||0.772|||||||t-test, 2 sided|||||||0.772
73819863|NCT03252145|147186698|OTHER|||||||0.3|||||||t-test, 2 sided|||||||0.300
73819864|NCT03252145|147186699|OTHER|||||||0.3|||||||t-test, 2 sided|||||||0.300
73819865|NCT03252145|147186700|OTHER|||||||0.679|||||||t-test, 2 sided|||||||0.679
73819866|NCT03252145|147186701|OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.120
73819867|NCT03252145|147186702|OTHER|||||||0.138|||||||t-test, 2 sided|||||||0.138
73819868|NCT03252145|147186703|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
73819869|NCT03252145|147186704|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
73819870|NCT03252145|147186706|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.080
73819871|NCT03252145|147186707|OTHER|||||||0.068|||||||t-test, 2 sided|||Physical Function Domain||||0.068
73819872|NCT03252145|147186707|OTHER|||||||0.808|||||||t-test, 2 sided|||Anxiety Domain||||0.808
73819873|NCT03252145|147186707|OTHER|||||||0.557|||||||t-test, 2 sided|||Depression Domain||||0.557
73819874|NCT03252145|147186707|OTHER|||||||0.049|||||||t-test, 2 sided|||Fatigue Domain||||0.049
73819875|NCT03252145|147186707|OTHER|||||||0.279|||||||t-test, 2 sided|||Sleep Disturbance Domain||||0.279
73819876|NCT03252145|147186707|OTHER|||||||0.02|||||||t-test, 2 sided|||Roles/Activity Domain||||0.020
73819877|NCT03252145|147186707|OTHER|||||||0.009|||||||t-test, 2 sided|||Pain Interference Domain||||0.009
73819878|NCT03252145|147186708|OTHER|||||||0.038|||||||t-test, 2 sided|||Physical Function Domain||||0.038
73819879|NCT03252145|147186708|OTHER|||||||0.108|||||||t-test, 2 sided|||Anxiety Domain||||0.108
73819880|NCT03252145|147186708|OTHER|||||||0.467|||||||t-test, 2 sided|||Depression Domain||||0.467
73819881|NCT03252145|147186708|OTHER|||||||0.078|||||||t-test, 2 sided|||Fatigue Domain||||0.078
73819882|NCT03252145|147186708|OTHER|||||||0.147|||||||t-test, 2 sided|||Sleep Disturbance Domain||||0.147
73819883|NCT03252145|147186708|OTHER|||||||0.004|||||||t-test, 2 sided|||Roles/Activity Domain||||0.004
73819884|NCT03252145|147186708|OTHER|||||||0.032|||||||t-test, 2 sided|||Pain Interference Domain||||0.032
73819885|NCT03252145|147186709|OTHER|||||||0.938|||||||t-test, 2 sided|||||||0.938
73819886|NCT03252145|147186710|OTHER|||||||0.603|||||||t-test, 2 sided|||||||0.603
73819887|NCT03252145|147186711|OTHER|||||||0.837|||||||t-test, 2 sided|||||||0.837
73819888|NCT03252145|147186712|OTHER|||||||0.511|||||||t-test, 2 sided|||||||0.511
73819889|NCT03252145|147186713|OTHER|||||||0.326|||||||t-test, 2 sided|||||||0.326
73819890|NCT04336475|147186721|SUPERIORITY|||||||0.564||||||The threshold for statistical significance was p=0.05. p value stands for the comparison of final oral aperture measurements between two groups. (after 2 months' period)|ANOVA|Repeated Measures ANOVA||||||0.564
73896523|NCT03456882|147326398|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|2.6||0.3585|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.3585
73819891|NCT03188523|147186723|SUPERIORITY||Posterior Mean Difference|-1.03|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was \>98%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).||||
73819892|NCT03188523|147186723|SUPERIORITY||Posterior Mean Difference|-0.92|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was \>95%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).||||
73819893|NCT03188523|147186739|OTHER||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.||||
73819894|NCT03188523|147186739|OTHER||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.||||
73819895|NCT01267929|147186750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.14||0.34|TWO_SIDED|95.0|-2.3|6.5||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the second month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the second month compared to those in the control group after adjusted for the baseline level.||6.5|-2.3|0.34
73819896|NCT01267929|147186750|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|2.7||0.78|TWO_SIDED|95.0|-6.3|4.7||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the sixth month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the sixth month compared to those in the control group after adjusted for the baseline level.||4.7|-6.3|0.78
73819897|NCT04727528|147186760|SUPERIORITY||Odds Ratio (OR)|56.2||||0.001|TWO_SIDED|95.0|5.6|563.6|||Wald Chi-Squared test||Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor.|||563.6|5.6|0.001
73819898|NCT04727528|147186761|SUPERIORITY||Least-squares mean|1.64|STANDARD_ERROR_OF_MEAN|0.81||0.05|TWO_SIDED|95.0|0.0|3.29|||t-test, 2 sided|||Difference between groups||3.29|-0.00|0.050
73819899|NCT04727528|147186762|SUPERIORITY||Odds Ratio (OR)|3.2||||0.153|TWO_SIDED|95.0|0.6|15.8|||Wald Chi-Squared test|||Comparison between groups||15.8|0.6|0.153
73819900|NCT04727528|147186763|SUPERIORITY||Odds Ratio (OR)|57008.6||||0.94|TWO_SIDED|95.0|0.0||The upper limit of the 95% confidence interval = 13124060000000000000000000000||Wald Chi-Squared test|||Comparison between groups|||0.0|0.940
73819901|NCT04727528|147186764|SUPERIORITY||Odds Ratio (OR)|2.2||||0.271|TWO_SIDED|95.0|0.5|8.6|||Wald Chi-Squared test|||Comparison between groups||8.6|0.5|0.271
73819902|NCT04727528|147186765|SUPERIORITY||Odds Ratio (OR)|10.8||||0.039|TWO_SIDED|95.0|1.1|102.8|||Wald Chi-Squared test|||Comparison between groups||102.8|1.1|0.039
73819903|NCT04727528|147186766|SUPERIORITY||Odds Ratio (OR)|57008.6||||0.94|TWO_SIDED|95.0|0.0||The upper limit of the 95% confidence interval = 13124060000000000000000000000||Wald Chi-Squared test|||Comparison between groups|||0.0|0.940
73819904|NCT01763827|147186779|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.14|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-61.14|-53.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.14|-61.14|<0.001
73819905|NCT01763827|147186779|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.78|STANDARD_ERROR_OF_MEAN|1.87|<|0.001|TWO_SIDED|95.0|-58.46|-51.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.10|-58.46|<0.001
73819906|NCT01763827|147186779|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.29|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-43.28|-35.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.31|-43.28|<0.001
73819907|NCT01763827|147186779|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.55|STANDARD_ERROR_OF_MEAN|1.88|<|0.001|TWO_SIDED|95.0|-41.24|-33.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.86|-41.24|<0.001
73819908|NCT01763827|147186780|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.5|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-59.95|-53.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.04|-59.95|<0.001
73819909|NCT01763827|147186780|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.4|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-60.66|-54.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.14|-60.66|<0.001
73819910|NCT01763827|147186780|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.41|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-42.87|-35.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.94|-42.87|<0.001
73819911|NCT01763827|147186780|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.69|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-42.97|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-36.42|-42.97|<0.001
73819912|NCT01763827|147186781|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.6|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-85.0|-74.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-74.2|-85.0|<0.001
73819913|NCT01763827|147186781|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-81.9|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-87.0|-76.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-76.9|-87.0|<0.001
73819914|NCT01763827|147186781|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-60.7|-49.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-49.9|-60.7|<0.001
73819915|NCT01763827|147186781|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-61.1|-51.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-51.0|-61.1|<0.001
73819916|NCT01763827|147186782|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-80.4|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-86.4|-74.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-74.3|-86.4|<0.001
73819917|NCT01763827|147186782|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.8|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-83.4|-72.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-72.2|-83.4|<0.001
73819918|NCT01763827|147186782|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-61.1|-49.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference|||-49.0|-61.1|<0.001
73819919|NCT01763827|147186782|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-58.5|-47.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference|||-47.3|-58.5|<0.001
73819920|NCT01763827|147186783|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|73.6|||<|0.001|TWO_SIDED|95.0|64.4|80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||80.2|64.4|<0.001
73819921|NCT01763827|147186783|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.3|||<|0.001|TWO_SIDED|95.0|62.2|78.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.0|62.2|<0.001
73819922|NCT01763827|147186783|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|72.2|||<|0.001|TWO_SIDED|95.0|62.4|78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.9|62.4|<0.001
73819923|NCT01763827|147186783|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|68.6|||<|0.001|TWO_SIDED|95.0|58.3|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||75.5|58.3|<0.001
73819924|NCT01763827|147186784|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.5|||<|0.001|TWO_SIDED|95.0|61.2|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.4|61.2|<0.001
73819925|NCT01763827|147186784|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|65.4|||<|0.001|TWO_SIDED|95.0|55.6|72.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||72.9|55.6|<0.001
73819926|NCT01763827|147186784|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.5|||<|0.001|TWO_SIDED|95.0|61.3|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.4|61.3|<0.001
73819927|NCT01763827|147186784|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.0|||<|0.001|TWO_SIDED|95.0|53.5|71.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||71.6|53.5|<0.001
73819928|NCT01763827|147186785|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.81|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-52.01|-45.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.61|-52.01|<0.001
73819929|NCT01763827|147186785|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.28|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-56.23|-50.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-50.33|-56.23|<0.001
73819930|NCT01763827|147186785|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.58|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-38.79|-32.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.38|-38.79|<0.001
73819931|NCT01763827|147186785|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.49|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-38.44|-32.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.53|-38.44|<0.001
73819932|NCT01763827|147186786|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.81|STANDARD_ERROR_OF_MEAN|1.79|<|0.001|TWO_SIDED|95.0|-53.34|-46.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-46.27|-53.34|<0.001
73819933|NCT01763827|147186786|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-51.19|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|-54.49|-47.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-47.90|-54.49|<0.001
73819934|NCT01763827|147186786|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.23|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-38.74|-31.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.71|-38.74|<0.001
73819935|NCT01763827|147186786|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.21|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-36.51|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.90|-36.51|<0.001
73819936|NCT01763827|147186787|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.09|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-50.67|-43.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-43.51|-50.67|<0.001
73819937|NCT01763827|147186787|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.93|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-54.27|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-47.59|-54.27|<0.001
73819938|NCT01763827|147186787|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.57|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-37.15|-29.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.99|-37.15|<0.001
73819939|NCT01763827|147186787|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.64|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-37.99|-31.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.28|-37.99|<0.001
73819940|NCT01763827|147186788|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.81|STANDARD_ERROR_OF_MEAN|1.91|<|0.001|TWO_SIDED|95.0|-51.56|-44.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-44.05|-51.56|<0.001
73819941|NCT01763827|147186788|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.43|STANDARD_ERROR_OF_MEAN|1.85|<|0.001|TWO_SIDED|95.0|-52.07|-44.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-44.79|-52.07|<0.001
73819942|NCT01763827|147186788|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.04|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-37.78|-30.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-30.30|-37.78|<0.001
73819943|NCT01763827|147186788|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.57|STANDARD_ERROR_OF_MEAN|1.85|<|0.001|TWO_SIDED|95.0|-36.21|-28.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-28.92|-36.21|<0.001
73819944|NCT01763827|147186789|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.93|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-42.0|-35.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-35.86|-42.00|<0.001
73819945|NCT01763827|147186789|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.83|STANDARD_ERROR_OF_MEAN|1.81|<|0.001|TWO_SIDED|95.0|-49.39|-42.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-42.27|-49.39|<0.001
73819946|NCT01763827|147186789|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.36|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-32.43|-26.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-26.28|-32.43|<0.001
73819947|NCT01763827|147186789|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.51|STANDARD_ERROR_OF_MEAN|1.81|<|0.001|TWO_SIDED|95.0|-31.08|-23.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-23.94|-31.08|<0.001
73819948|NCT01763827|147186790|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.63|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|-42.97|-36.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-36.30|-42.97|<0.001
73819949|NCT01763827|147186790|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.67|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-48.66|-40.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-40.68|-48.66|<0.001
73819950|NCT01763827|147186790|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.42|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-31.73|-25.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-25.10|-31.73|<0.001
73819951|NCT01763827|147186790|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.31|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-29.31|-21.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-21.31|-29.31|<0.001
73819952|NCT01763827|147186791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.12|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-53.12|-45.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.12|-53.12|<0.001
73819953|NCT01763827|147186791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.95|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-59.12|-50.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-50.78|-59.12|<0.001
73819954|NCT01763827|147186791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.73|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-38.73|-30.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-30.73|-38.73|<0.001
73819955|NCT01763827|147186791|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.62|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-40.81|-32.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.42|-40.81|<0.001
73819956|NCT01763827|147186792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.57|STANDARD_ERROR_OF_MEAN|2.14|<|0.001|TWO_SIDED|95.0|-53.78|-45.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.36|-53.78|<0.001
73819957|NCT01763827|147186792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.77|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-57.28|-48.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-48.26|-57.28|<0.001
73819958|NCT01763827|147186792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.76|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-39.95|-31.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.57|-39.95|<0.001
73819959|NCT01763827|147186792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.97|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-38.48|-29.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.45|-38.48|<0.001
73819960|NCT01763827|147186793|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-18.48|||<|0.001|TWO_SIDED|95.0|-25.28|-11.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.68|-25.28|<0.001
73819961|NCT01763827|147186793|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-19.24|||<|0.001|TWO_SIDED|95.0|-23.2|-15.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-15.28|-23.20|<0.001
73819962|NCT01763827|147186793|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-18.37|||<|0.001|TWO_SIDED|95.0|-24.39|-12.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-12.35|-24.39|<0.001
73819963|NCT01763827|147186793|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.15|||<|0.001|TWO_SIDED|95.0|-23.23|-11.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.08|-23.23|<0.001
73819964|NCT01763827|147186794|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.41|||<|0.001|TWO_SIDED|95.0|-27.76|-13.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-13.06|-27.76|<0.001
73819965|NCT01763827|147186794|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.82|||<|0.001|TWO_SIDED|95.0|-24.51|-11.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.12|-24.51|<0.001
73819966|NCT01763827|147186794|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.41|||<|0.001|TWO_SIDED|95.0|-28.13|-12.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-12.69|-28.13|<0.001
73819967|NCT01763827|147186794|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-15.77|||<|0.001|TWO_SIDED|95.0|-24.39|-7.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-7.14|-24.39|<0.001
73819968|NCT01763827|147186795|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-5.27||||0.72|TWO_SIDED|95.0|-13.27|2.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.73|-13.27|0.72
73819969|NCT01763827|147186795|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.59|||<|0.001|TWO_SIDED|95.0|-30.98|-10.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-10.20|-30.98|<0.001
73819970|NCT01763827|147186795|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-7.71||||0.027|TWO_SIDED|95.0|-16.86|1.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||1.45|-16.86|0.027
73819971|NCT01763827|147186795|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-11.73||||0.044|TWO_SIDED|95.0|-21.19|-2.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-2.27|-21.19|0.044
73819972|NCT01763827|147186796|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-6.23||||0.72|TWO_SIDED|95.0|-16.41|3.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||3.95|-16.41|0.72
73819973|NCT01763827|147186796|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.65|||<|0.001|TWO_SIDED|95.0|-26.67|-8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm|||-8.63|-26.67|<0.001
73819974|NCT01763827|147186796|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-8.14||||0.027|TWO_SIDED|95.0|-17.54|1.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||1.26|-17.54|0.027
73819975|NCT01763827|147186796|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-13.23||||0.044|TWO_SIDED|95.0|-21.69|-4.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-4.77|-21.69|0.044
73819976|NCT01763827|147186797|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-4.59||||0.072|TWO_SIDED|95.0|-11.3|2.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.12|-11.30|0.072
73819977|NCT01763827|147186797|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.39|||<|0.001|TWO_SIDED|95.0|-30.11|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-10.68|-30.11|<0.001
73819978|NCT01763827|147186797|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-5.71||||0.082|TWO_SIDED|95.0|-14.13|2.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.71|-14.13|0.082
73819979|NCT01763827|147186797|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-12.84||||0.044|TWO_SIDED|95.0|-22.14|-3.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baselie value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-3.54|-22.14|0.044
73819980|NCT01763827|147186798|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-7.94||||0.72|TWO_SIDED|95.0|-18.81|2.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.92|-18.81|0.72
73819981|NCT01763827|147186798|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-16.33|||<|0.001|TWO_SIDED|95.0|-25.64|-7.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-7.02|-25.64|<0.001
73819982|NCT01763827|147186798|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-8.58||||0.082|TWO_SIDED|95.0|-18.1|0.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||0.94|-18.10|0.082
73819983|NCT01763827|147186798|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-12.72||||0.044|TWO_SIDED|95.0|-20.89|-4.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-4.54|-20.89|0.044
73819984|NCT01763827|147186799|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.53||||0.007|TWO_SIDED|95.0|2.23|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.84|2.23|0.007
73819985|NCT01763827|147186799|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|8.48|||<|0.001|TWO_SIDED|95.0|5.53|11.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||11.43|5.53|<0.001
73819986|NCT01763827|147186799|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|4.81||||0.013|TWO_SIDED|95.0|0.85|8.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.78|0.85|0.013
73819987|NCT01763827|147186799|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|3.81||||0.044|TWO_SIDED|95.0|-0.77|8.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline visit|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.39|-0.77|0.044
73819988|NCT01763827|147186800|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.91||||0.007|TWO_SIDED|95.0|1.67|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||10.16|1.67|0.007
73819989|NCT01763827|147186800|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|9.33|||<|0.001|TWO_SIDED|95.0|5.32|13.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||13.34|5.32|<0.001
73819990|NCT01763827|147186800|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|7.56||||0.013|TWO_SIDED|95.0|3.11|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||12.00|3.11|0.013
73819991|NCT01763827|147186800|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.53||||0.044|TWO_SIDED|95.0|2.22|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.84|2.22|0.044
73819992|NCT03498313|147186900|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.082||0.002|TWO_SIDED|95.0|-0.41|-0.08|||Mixed Models Analysis|This is the p-value for the Treatment X Cycle Phase Interaction. Kenward-Roger Method was utilized for degrees of freedom.|Placebo represents the reference treatment.|Fixed interaction effect of treatment (0=Placebo, 1=E2) by cycle phase (0=Lower-Risk Early Luteal Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||-.08|-.41|.002
73819993|NCT03498313|147186900|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.083||0.46|TWO_SIDED|95.0|-0.22|0.1|||Mixed Models Analysis|This is the p-value for the Treatment X Cycle Phase Interaction. Kenward-Roger Method was utilized for degrees of freedom.|Placebo Represents the Reference Condition.|Fixed interaction effect of treatment (0=Placebo, 1=P4) by cycle phase (0=Lower-Risk Early Luteal Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||.10|-.22|.46
73819994|NCT02171429|147186903|SUPERIORITY||Difference in Remission Rates|7.2||||0.1729|TWO_SIDED|95.0|-3.83|16.12||The threshold for statistical significance was a p-value \<0.05.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|The null hypothesis (H0): the percentage of participants achieving remission at Week 10 was the same in both the placebo and etrolizumab arms. The alternative hypothesis (H1): the percentage of participants achieving remission at Week 10 was not the same in the placebo and etrolizumab arms.||16.12|-3.83|0.1729
73819995|NCT02171429|147186904|SUPERIORITY||Difference in Remission Rates|-6.8||||0.1458|TWO_SIDED|95.0|-16.26|2.73||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.73|-16.26|0.1458
73819996|NCT02171429|147186905|SUPERIORITY||Difference in Remission Rates|-5.0||||1|TWO_SIDED|95.0|-11.66|1.75||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||1.75|-11.66|1
73819997|NCT02171429|147186906|SUPERIORITY||Difference in Response Rates|14.0||||0.1729|TWO_SIDED|95.0|-0.12|27.19||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||27.19|-0.12|0.1729
73896524|NCT03456882|147326399|SUPERIORITY|||||||0.4388||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.4388
73819998|NCT02171429|147186906|SUPERIORITY||Difference in Response Rates|-2.5||||0.6726|TWO_SIDED|95.0|-13.83|9.01||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.01|-13.83|0.6726
73819999|NCT02171429|147186907|SUPERIORITY||Difference in Response Rates|1.2||||1|TWO_SIDED|95.0|-6.98|9.26||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.26|-6.98|1
73820000|NCT02171429|147186908|SUPERIORITY||Difference in Response Rates|9.4||||0.2372|TWO_SIDED|95.0|-4.31|21.95||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||21.95|-4.31|0.2372
73820001|NCT02171429|147186908|SUPERIORITY||Difference in Response Rates|-3.5||||0.5341|TWO_SIDED|95.0|-14.76|7.82||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||7.82|-14.76|0.5341
73820002|NCT02171429|147186909|SUPERIORITY||Difference in Response Rates|1.9||||1|TWO_SIDED|95.0|-6.04|9.88||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.88|-6.04|1
73820003|NCT02171429|147186910|SUPERIORITY||Difference in Remission Rates|11.2||||0.2372|TWO_SIDED|95.0|0.59|19.76||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||19.76|0.59|0.2372
73820004|NCT02171429|147186910|SUPERIORITY||Difference in Remission Rates|-7.5||||0.1192|TWO_SIDED|95.0|-17.2|2.33||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.33|-17.20|0.1192
73820005|NCT02171429|147186911|SUPERIORITY||Difference in Remission Rates|-3.5||||1|TWO_SIDED|95.0|-10.27|3.3||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||3.30|-10.27|1
73820006|NCT02171429|147186912|SUPERIORITY||Difference in Remission Rates|9.6||||0.2729|TWO_SIDED|95.0|-4.71|22.02||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||22.02|-4.71|0.2729
73820007|NCT02171429|147186912|SUPERIORITY||Difference in Remission Rates|-14.8||||0.0215|TWO_SIDED|95.0|-26.97|-2.04||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||-2.04|-26.97|0.0215
73820008|NCT02171429|147186913|SUPERIORITY||Difference in Remission Rates|-0.3||||1|TWO_SIDED|95.0|-9.13|8.45||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||8.45|-9.13|1
73820009|NCT02171429|147186914|SUPERIORITY|||||||0.1729||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.1729
73820010|NCT02171429|147186914|SUPERIORITY|||||||0.2864||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.2864
73820011|NCT02171429|147186915|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
73820012|NCT02171429|147186916|SUPERIORITY|||||||0.1729||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.1729
73820013|NCT02171429|147186916|SUPERIORITY|||||||0.4174||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.4174
73820014|NCT02171429|147186917|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
73820015|NCT02171429|147186918|SUPERIORITY||Mean Difference (Net)|-1.1||||0.1659|TWO_SIDED|95.0|-2.8|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-2.8|0.1659
73820016|NCT02171429|147186918|SUPERIORITY||Mean Difference (Net)|0.1||||0.9182|TWO_SIDED|95.0|-1.3|1.4||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||1.4|-1.3|0.9182
73820017|NCT02171429|147186919|SUPERIORITY||Mean Difference (Net)|-1.0||||1|TWO_SIDED|95.0|-2.1|0.2||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.2|-2.1|1
73820018|NCT02171429|147186919|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-1.2|0.7||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.7|-1.2|1
73820019|NCT02171429|147186920|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0116|TWO_SIDED|95.0|-1.7|-0.2||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||-0.2|-1.7|0.0116
73820020|NCT02171429|147186920|SUPERIORITY||Mean Difference (Net)|-0.1||||0.6771|TWO_SIDED|95.0|-0.8|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-0.8|0.6771
73820021|NCT02171429|147186921|SUPERIORITY||Mean Difference (Net)|-0.5||||1|TWO_SIDED|95.0|-1.0|0.0||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.0|-1.0|1
73820022|NCT02171429|147186921|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-0.7|0.1||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.1|-0.7|1
73820023|NCT02171429|147186922|SUPERIORITY||Difference in Remission Rates|7.9||||0.1382|TWO_SIDED|95.0|-3.19|16.87||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||16.87|-3.19|0.1382
73820024|NCT02171429|147186922|SUPERIORITY||Difference in Remission Rates|-7.5||||0.1163|TWO_SIDED|95.0|-17.1|2.22||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.22|-17.10|0.1163
73820025|NCT02171429|147186923|SUPERIORITY||Difference in Remission Rates|2.9||||0.4772|TWO_SIDED|95.0|-6.47|10.14||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||10.14|-6.47|0.4772
73820026|NCT02171429|147186923|SUPERIORITY||Difference in Remission Rates|-5.2||||0.1801|TWO_SIDED|95.0|-12.95|2.63||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.63|-12.95|0.1801
73820027|NCT02171429|147186924|SUPERIORITY||Difference in Adjusted Means|4.0||||0.4833|TWO_SIDED|95.0|-7.2|15.2||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||15.2|-7.2|0.4833
73896525|NCT03456882|147326399|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|20.2||0.9887|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.9887
73820028|NCT02171429|147186924|SUPERIORITY||Difference in Adjusted Means|0.0||||0.9931|TWO_SIDED|95.0|-9.2|9.1||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.1|-9.2|0.9931
73820029|NCT02020889|147186931|OTHER||Odds Ratio (OR)|5.91|||<|0.001|TWO_SIDED|95.0|2.68|13.03|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||13.03|2.68|<0.001
73820030|NCT02020889|147186932|OTHER||Odds Ratio (OR)|16.74|||<|0.001|TWO_SIDED|95.0|3.61|77.56|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||77.56|3.61|<0.001
73820031|NCT02020889|147186933|OTHER||Hazard Ratio (HR)|0.322|||<|0.001|TWO_SIDED|95.0|0.206|0.502|||Cox Proportional Hazard regression|Cox proportional hazards model with covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||0.502|0.206|<0.001
73820032|NCT02020889|147186934|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.09|0.41|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||0.41|0.09|<0.001
73820033|NCT02020889|147186935|OTHER||Odds Ratio (OR)|19.65||||0.007|TWO_SIDED|95.0|2.3|167.93|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||167.93|2.30|0.007
73820034|NCT02020889|147186936|OTHER||Odds Ratio (OR)|5.31|||<|0.001|TWO_SIDED|95.0|2.63|10.74|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||10.74|2.63|<0.001
73820035|NCT02020889|147186937|OTHER||Odds Ratio (OR)|7.19|||<|0.001|TWO_SIDED|95.0|2.6|19.87|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||19.87|2.60|<0.001
73820036|NCT02020889|147186938|OTHER||Odds Ratio (OR)|11.39||||0.003|TWO_SIDED|95.0|2.35|55.24|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.|Mepolizumab 300mg/Placebo|||55.24|2.35|0.003
73820037|NCT01768559|147186963|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin of 0.4%.|Least Square (LS) Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.17|0.064|||ANCOVA||Lixisenatide vs Insulin Glulisine QD|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use, and country as fixed effects and baseline HbA1c value as a covariate. The non-inferiority was assessed using upper bound of 2-sided 95% Confidence Interval (CI).||0.064|-0.17|
73820038|NCT01768559|147186963|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin of 0.4%.|LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|0.095|0.328|||ANCOVA||Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at significance level = 0.025 (1-sided) for comparison between Lixisenatide vs Insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).||0.328|0.095|
73820039|NCT01768559|147186964|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.305|<|0.0001|TWO_SIDED|95.0|-2.593|-1.396||Threshold for significance at 0.025 level.|ANCOVA|The superiority was assessed by comparing the P-value at significance level = 0.025 or 0.0125.|Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at α = 0.025 (1-sided) for comparison between lixisenatide vs insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).||-1.396|-2.593|< 0.0001
73820040|NCT01515696|147186982|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.61
73820041|NCT01515696|147186983|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.5||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
73820042|NCT01515696|147186984|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
73820043|NCT00351936|147186994|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||||||0.003
73820044|NCT00351936|147186995|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||||||0.003
73820045|NCT00351936|147186996|SUPERIORITY_OR_OTHER|||||||0.747||95.0|||||ANCOVA|||||||0.747
73820046|NCT00351936|147186997|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||ANCOVA|||||||0.208
73820047|NCT00351936|147186998|SUPERIORITY_OR_OTHER|||||||0.665||95.0|||||ANCOVA|||||||0.665
73820048|NCT00351936|147186999|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||ANCOVA|||||||0.999
73820049|NCT00351936|147187000|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
73820050|NCT04560868|147187013|EQUIVALENCE|The point null hypothesis was a difference in expected number of log ins of exactly 0.|Mean Difference (Final Values)|12.73|||<|0.01|TWO_SIDED|95.0|6.41|19.05|||Regression, Linear||mean difference=experimental-control|Based on a priori power calculations we had 80% power to detect an average increase of 3.8 log ins in the experimental relative to the control arm.||19.05|6.41|<0.01
73820051|NCT04560868|147187014|EQUIVALENCE|The null hypothesis was a point null of relative risk equal to exactly 1.|Risk Ratio (RR)|1.01||||0.98|TWO_SIDED|95.0|0.55|1.85|||Regression, Poisson||relative risk=experimental/control|Based on a priori power calculations, we had 80% power to detect a 33% - 35% increase in the proportion of experimental participants who successfully quit smoking for at least 24 hours relative to controls.||1.85|0.55|0.98
73820052|NCT04560868|147187015|EQUIVALENCE|The null hypothesis was a point null of exactly 0 risk difference between arms.|Risk Difference (RD)|0.08||||0.35|TWO_SIDED|95.0|-0.08|0.24|||Regression, Linear||Risk difference = experimental - control.|Based on a priori power calculations, we had 80% power to detect a 28% - 33% increase in 7-day smoking abstinence in the experimental arm relative to the control arm at 3 months.||0.24|-0.08|0.35
73820053|NCT04560868|147187016|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|0.26||||0.4|TWO_SIDED|95.0|-0.35|0.87|||Regression, Linear||mean difference=experimental-control|||0.87|-0.35|0.40
73820054|NCT04560868|147187017|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|-0.04||||0.9|TWO_SIDED|95.0|-0.68|0.6|||Regression, Linear||mean difference=experimental-control|||0.60|-0.68|0.90
73820055|NCT04560868|147187018|EQUIVALENCE|The tested hypothesis was a point null of 0 difference in expected average helpfulness score between arms.|Mean Difference (Final Values)|0.4||||0.39|TWO_SIDED|95.0|-0.5|1.4|||Regression, Linear||mean difference=experimental-control|||1.4|-0.5|0.39
73820056|NCT04560868|147187019|EQUIVALENCE|The tested hypothesis was for a point null of 0 difference in expected average helpfulness score between arms.|Mean Difference (Final Values)|0.6||||0.11|TWO_SIDED|95.0|-0.1|1.3|||Regression, Linear||mean difference=experimental-control|||1.3|-0.1|0.11
73820057|NCT04560868|147187021|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected number of badges earned in each arm by 3 months post-baseline.|Mean Difference (Final Values)|4.2|||<|0.01|TWO_SIDED|95.0|1.72|6.65|||Regression, Linear||mean difference=experimental-control|||6.65|1.72|<0.01
73820058|NCT04560868|147187022|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|0.08||||0.96|TWO_SIDED|95.0|-1.02|1.18|||Regression, Linear||mean difference=experimental-control|||1.18|-1.02|0.96
73820059|NCT04560868|147187023|EQUIVALENCE|The null hypothesis was a point null hypothesis of exactly 0 difference in expected score between the arms.|Mean Difference (Final Values)|-0.44||||0.31|TWO_SIDED|95.0|-1.55|0.66|||Regression, Linear||mean difference=experimental-control|||0.66|-1.55|0.31
73820060|NCT04560868|147187027|EQUIVALENCE|The point null hypothesis was of the exact same proportion of control and experimental subjects requesting NRT.|Risk Ratio (RR)|3.9||||0.06|TWO_SIDED|95.0|0.9|16.9|||Regression, Poisson||RR=experimental/control|||16.9|0.9|0.06
73820061|NCT04560868|147187028|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in probability of the outcome between arms.|Risk Ratio (RR)|1.01||||0.99|TWO_SIDED|95.0|0.38|2.65|||Regression, Poisson||risk ratio=experimental/control|||2.65|0.38|0.99
73820062|NCT04560868|147187029|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected change from baseline in number of cigarettes smoked per day between arms.|Mean Difference (Net)|1.39||||0.3|TWO_SIDED|95.0|-1.21|3.99|||Regression, Linear||treatment difference=experimental-control, where the outcome for each individual is (one month)-baseline.|||3.99|-1.21|0.30
73820063|NCT04560868|147187030|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected change in daily cigarette usage between arms.|Mean Difference (Net)|1.5||||0.47|TWO_SIDED|95.0|-2.51|5.5|||Regression, Linear||treatment effect=experimental-control, where the outcome for each individual is (three month)-baseline.|||5.5|-2.51|0.47
73820064|NCT04560868|147187031|EQUIVALENCE|The null hypothesis was risk difference of exactly 0.|Risk Difference (RD)|0.04||||0.3|TWO_SIDED|95.0|-0.03|0.11|||Regression, Linear||risk difference=experimental-control|||0.11|-0.03|0.30
73820065|NCT02179047|147187035|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
73820066|NCT02179047|147187036|SUPERIORITY||Hazard Ratio (HR)|1.05|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|95.0|||||ANOVA|||||||0.002
73820067|NCT02179047|147187037|SUPERIORITY||Hazard Ratio (HR)|1.39|STANDARD_DEVIATION|0.005||0.001|TWO_SIDED||||||ANCOVA|||||||0.001
73820068|NCT01393522|147187038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED||||||ANCOVA|||||||0.1
73820069|NCT01393522|147187038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
73820070|NCT01393522|147187039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|TWO_SIDED||||||t-test, 2 sided|||||||0.33
73820071|NCT01393522|147187040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|TWO_SIDED||||||ANCOVA|||||||0.75
73820072|NCT01393522|147187040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||t-test, 2 sided|||||||0.24
73820073|NCT01393522|147187041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
73820074|NCT01393522|147187042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|TWO_SIDED||||||t-test, 2 sided|||||||0.41
73820075|NCT01393522|147187043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.09
73820076|NCT01393522|147187044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
73820077|NCT03746405|147187047|SUPERIORITY||Mean Difference (Final Values)|1.15|||=|0.03|TWO_SIDED|||||Give the limited sample size, this p-value was not adjusted for multiple comparisons. The threshold for statistical significant was p \< 0.05|t-test, 2 sided|||Hypothesis: Active rTMS applied over the node in the medial prefrontal cortex the most strongly negatively connected to the right amygdala will decrease amygdala BOLD activation compared to sham rTMS||||= 0.03
73820078|NCT03479008|147187048|OTHER||||||<|0.0001||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||This presents the p value for the thigh comparison baseline to during stimulation||||<0.0001
73820079|NCT03479008|147187048|SUPERIORITY||||||<|0.0001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||This presents the p value for the calf comparisons between baseline and during stimulation.||||<0.0001
73820080|NCT03479008|147187048|OTHER||||||<|0.001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||This statistical analysis presents the data for the biceps comparisons between baseline and during stimulation.||||<0.001
73820081|NCT03479008|147187049|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||The P value below applies to the VO2||||<0.0001
73820082|NCT03479008|147187049|SUPERIORITY||||||<|0.001|||||||post-hoc analysis|with Bonferroni correction||This p value applies to the VCO2||||<0.001
73820083|NCT03479008|147187050|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||||||<0.0001
73820084|NCT03479008|147187051|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||||||<0.0001
73820085|NCT03479008|147187052|SUPERIORITY|||||||0.094|||||||post-hoc analysis|with Bonferroni correction||||||0.094
73820086|NCT03479008|147187053|SUPERIORITY|||||||0.011||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for Muscle bellies of Soleus (SO)||||0.011
73820087|NCT03479008|147187053|SUPERIORITY|||||||0.012|||||||ANOVA|Statistical significance level was set at p \< 0.05 for all tests.||Comparison of Vibration to Baseline for tibialis anterior (TA)||||0.012
73820088|NCT03479008|147187053|SUPERIORITY|||||||0.003||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for gastrocnemius lateralis (GL)||||0.003
73820089|NCT03479008|147187053|SUPERIORITY||||||<|0.001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for vastus medialis (VM)||||<0.001
73820090|NCT03479008|147187053|SUPERIORITY||||||<|0.0001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for vastus lateralis (VL)||||<0.0001
73820091|NCT03479008|147187053|SUPERIORITY|||||||0.59||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for rectus femoris (RF)||||0.59
73820092|NCT03479008|147187053|SUPERIORITY|||||||0.86||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for semitendinosus (ST)||||0.86
73820093|NCT03479008|147187053|SUPERIORITY|||||||0.006||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for deltoideus medius||||0.006
73820094|NCT00412932|147187054|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.||||<0.0001
73820095|NCT00412932|147187055|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||||||<0.0001
73820096|NCT00412932|147187056|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments. This P-Value applies to both the daytime and nighttime periods.|one-sample t-test|||||||<0.0001
73820097|NCT00412932|147187057|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments. The P-Value of \<0.0001 applies to both daytime and nighttime periods.|one-sample t-test|||||||<0.0001
73820098|NCT01490840|147187061|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 90 in each group would have 80% power to detect a difference in means of 3.8, assuming that the common standard deviation is 9.05, using a two group t-test with a 0.05 2-sided significance level.|Mean Difference (Net)|-1.47||||0.4579|TWO_SIDED|95.0|-5.39|2.44|||ANCOVA|||||2.44|-5.39|0.4579
73820099|NCT01704755|147187072|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|91.8|||||TWO_SIDED|97.5|87.6|96.1||||||The study planned to enroll 380 subjects to a 12- or 24-week treatment arm. The primary efficacy endpoint (SVR12) was assessed for each arm. With a total sample size of 380 and assuming that 68% of the subjects in each arm would achieve SVR12, the study had greater than 90% power to demonstrate non-inferiority and superiority with a 2-sided 97.5% lower confidence bound greater than 43% and 54%, respectively, based on the normal approximation of a single binomial proportion.||96.1|87.6|
73820100|NCT01704755|147187072|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|91.8|||||TWO_SIDED|97.5|87.6|96.1||||||The primary efficacy endpoints were the SVR12 rates in each arm. The overall 2-sided significance level of 0.05 was split between the arms using a Bonferroni correction of 0.025. A 2-sided 97.5% CI of the SVR12 rate per arm was computed using the normal approximation to the binomial distribution. A gatekeeping testing procedure was used to control the Type I error rate at 0.05, and the primary endpoints for Arm A were tested separately from Arm B in a pre-specified order.||96.1|87.6|
73820101|NCT01704755|147187072|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|96.5|||||TWO_SIDED|97.5|93.4|99.7||||||||99.7|93.4|
73820102|NCT01704755|147187072|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|96.5|||||TWO_SIDED|97.5|93.4|99.7||||||||99.7|93.4|
73820103|NCT01704755|147187073|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|TWO_SIDED||||||Regression, Logistic|||To test the hypothesis that the percentages of participants who achieved sustained virologic response 12 weeks after treatment was different between the two treatment groups, the percentages were compared using a logistic regression model with treatment group, baseline log(subscript)10(subscript) HCV RNA level, HCV subgenotype (1a, non-1a), IL28B genotype (CC, non CC), and peginterferon-ribavirin treatment history (treatment-naïve or treatment-experienced) as predictors.||||0.051
73820104|NCT01639703|147187127|OTHER||Odds Ratio (OR)|0.76||||0.2476|TWO_SIDED|95.0|0.47|1.21|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.21|0.47|0.2476
73820105|NCT01639703|147187128|OTHER||Odds Ratio (OR)|1.13||||0.5354|TWO_SIDED|95.0|0.77|1.66|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.66|0.77|0.5354
73820106|NCT01639703|147187129|OTHER||Odds Ratio (OR)|0.9||||0.3487|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.13|0.71|0.3487
73820107|NCT01639703|147187130|OTHER||Odds Ratio (OR)|1.08||||0.4195|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.29|0.90|0.4195
73820108|NCT01639703|147187131|OTHER||Odds Ratio (OR)|0.9||||0.7127|TWO_SIDED|95.0|0.53|1.54|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.54|0.53|0.7127
73820109|NCT01639703|147187132|OTHER||Odds Ratio (OR)|1.41||||0.1753|TWO_SIDED|95.0|0.86|2.31|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||2.31|0.86|0.1753
73820110|NCT00551525|147187177|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance level 0.05, two-sided test|binomial proportion|||||||<0.001
73820111|NCT00551525|147187180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.984|||||TWO_SIDED|95.0|0.91|1.063||||||Modeling the association of age with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), baseline PSA, and Gleason score (\<8 vs. 8-10\[reference level\]).||1.063|0.910|
73820112|NCT00551525|147187180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.89|1.169||||||Modeling the association of baseline PSA with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), Gleason score (\<8 vs. 8-10\[reference level\]), and age.||1.169|0.890|
73820113|NCT00551525|147187180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.307|||||TWO_SIDED|95.0|0.364|4.697||||||Modeling the association of clinical T-stage (pT2 vs. pT3 \[reference level\]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for baseline PSA, Gleason score (\<8 vs. 8-10\[reference level\]), and age.||4.697|0.364|
73820114|NCT00551525|147187180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.659|||||TWO_SIDED|95.0|0.217|2.006||||||Modeling the association of Gleason score (\<8 vs. 8-10\[reference level\]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), baseline PSA, and age.||2.006|0.217|
73820115|NCT04676724|147187216|OTHER||Difference in SVR Rate|-3.0|||||TWO_SIDED|95.0|-29.0|11.0|||||The point estimate of SVR and its 95% highest posterior density Credible Interval (CI) are estimated from a Bayesian model that incorporates the analysis stratification factors and treatment arm.|||11|-29|
73820116|NCT01150903|147187225|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-square test was used to calculate p-value.||||<0.001
73820117|NCT01150903|147187226|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-square test was used to calculate p-value.||||<0.001
73820118|NCT02081001|147187238|SUPERIORITY_OR_OTHER||Point estimate ratio|2.06|STANDARD_ERROR_OF_MEAN|1.19||0.23|TWO_SIDED|90.0|0.74|5.75|||Mixed Models Analysis|||||5.75|0.74|0.23
73820119|NCT02081001|147187238|SUPERIORITY_OR_OTHER||Point estimate ratio|1.25|STANDARD_ERROR_OF_MEAN|0.43||0.52|TWO_SIDED|90.0|0.69|2.28|||Mixed Models Analysis|||||2.28|0.69|0.52
73820120|NCT02081001|147187238|SUPERIORITY_OR_OTHER||Point estimate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.19||0.49|TWO_SIDED|90.0|0.59|1.25|||Mixed Models Analysis|||||1.25|0.59|0.49
73820121|NCT02081001|147187239|SUPERIORITY_OR_OTHER||Point estimate ratio|1.37|STANDARD_ERROR_OF_MEAN|0.34||0.23|TWO_SIDED|90.0|0.88|2.12|||Mixed Models Analysis|||||2.12|0.88|0.23
73820122|NCT02081001|147187239|SUPERIORITY_OR_OTHER||Point estimate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.18||0.09|TWO_SIDED|90.0|1.01|1.65|||Mixed Models Analysis|||||1.65|1.01|0.09
73820123|NCT02081001|147187239|SUPERIORITY_OR_OTHER||Point estimate ratio|1.36|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|90.0|1.11|1.67|||Mixed Models Analysis|||||1.67|1.11|0.02
73820124|NCT02081001|147187240|SUPERIORITY_OR_OTHER||Point estimate ratio|1.26|STANDARD_ERROR_OF_MEAN|0.19||0.15|TWO_SIDED|90.0|0.97|1.64|||Mixed Models Analysis|||||1.64|0.97|0.15
73820125|NCT02081001|147187240|SUPERIORITY_OR_OTHER||Point estimate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.26||0.24|TWO_SIDED|90.0|0.9|1.84|||Mixed Models Analysis|||||1.84|0.90|0.24
73820126|NCT02081001|147187240|SUPERIORITY_OR_OTHER||Point estimate ratio|0.83|STANDARD_ERROR_OF_MEAN|0.15||0.31|TWO_SIDED|90.0|0.6|1.14|||Mixed Models Analysis|||||1.14|0.60|0.31
73820127|NCT02081001|147187241|SUPERIORITY_OR_OTHER||Point estimate ratio|1.18|STANDARD_ERROR_OF_MEAN|0.11||0.09|TWO_SIDED|90.0|1.01|1.39|||Mixed Models Analysis|||||1.39|1.01|0.09
73820128|NCT02081001|147187241|SUPERIORITY_OR_OTHER||Point estimate ratio|1.12|STANDARD_ERROR_OF_MEAN|0.12||0.29|TWO_SIDED|90.0|0.93|1.35|||Mixed Models Analysis|||||1.35|0.93|0.29
73820129|NCT02081001|147187241|SUPERIORITY_OR_OTHER||Point estimate ratio|1.11|STANDARD_ERROR_OF_MEAN|0.09||0.24|TWO_SIDED|90.0|0.96|1.28|||Mixed Models Analysis|||||1.28|0.96|0.24
73820130|NCT02081001|147187242|SUPERIORITY_OR_OTHER||Point estimate ratio|0.91|STANDARD_ERROR_OF_MEAN|0.22||0.7|TWO_SIDED|90.0|0.6|1.38|||Mixed Models Analysis|||||1.38|0.60|0.70
73820131|NCT02081001|147187242|SUPERIORITY_OR_OTHER||Point estimate ratio|1.26|STANDARD_ERROR_OF_MEAN|0.21||0.19|TWO_SIDED|90.0|0.94|1.68|||Mixed Models Analysis|||||1.68|0.94|0.19
73820132|NCT02081001|147187242|SUPERIORITY_OR_OTHER||Point estmate ratio|1.45|STANDARD_ERROR_OF_MEAN|0.26||0.052|TWO_SIDED|90.0|1.07|1.98|||Mixed Models Analysis|||||1.98|1.07|0.052
73820133|NCT02081001|147187243|SUPERIORITY_OR_OTHER||Point estimate ratio|2.02|STANDARD_ERROR_OF_MEAN|0.95||0.16|TWO_SIDED|90.0|0.87|4.66|||Mixed Models Analysis|||||4.66|0.87|0.16
73820134|NCT02081001|147187243|SUPERIORITY_OR_OTHER||Point estimate ratio|1.31|STANDARD_ERROR_OF_MEAN|0.49||0.48|TWO_SIDED|90.0|0.68|2.54|||Mixed Models Analysis|||||2.54|0.68|0.48
73820135|NCT02081001|147187243|SUPERIORITY_OR_OTHER||Point estimate ratio|0.8|STANDARD_ERROR_OF_MEAN|0.16||0.28|TWO_SIDED|90.0|0.57|1.13|||Mixed Models Analysis|||||1.13|0.57|0.28
73820136|NCT02081001|147187244|SUPERIORITY_OR_OTHER||Point estimate ratio|1.06|STANDARD_ERROR_OF_MEAN|0.12||0.61|TWO_SIDED|90.0|0.87|1.3|||Mixed Models Analysis|||||1.30|0.87|0.61
73820137|NCT02081001|147187244|SUPERIORITY_OR_OTHER||Point estimate ratio|1.19|STANDARD_ERROR_OF_MEAN|0.16||0.22|TWO_SIDED|90.0|0.94|1.5|||Mixed Models Analysis|||||1.5|0.94|0.22
73820138|NCT02081001|147187244|SUPERIORITY_OR_OTHER||Point estimate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.12||0.26|TWO_SIDED|90.0|0.66|1.09|||Mixed Models Analysis|||||1.09|0.66|0.26
73820139|NCT02081001|147187245|SUPERIORITY_OR_OTHER||Point estimate ratio|1.18|STANDARD_ERROR_OF_MEAN|0.14||0.19|TWO_SIDED|90.0|0.96|1.46|||Mixed Models Analysis|||||1.46|0.96|0.19
73820140|NCT02081001|147187245|SUPERIORITY_OR_OTHER||Point estimate ratio|1.15|STANDARD_ERROR_OF_MEAN|0.12||0.21|TWO_SIDED|90.0|0.95|1.38|||Regression, Cox|||||1.38|0.95|0.21
73820141|NCT02081001|147187245|SUPERIORITY_OR_OTHER||Point estimate ratio|1.13|STANDARD_ERROR_OF_MEAN|0.1||0.19|TWO_SIDED|90.0|0.97|1.31|||Mixed Models Analysis|||||1.31|0.97|0.19
73820142|NCT02081001|147187246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.4||0.24|TWO_SIDED|95.0|-17.1|4.3|||Mixed Models Analysis|||||4.3|-17.1|0.24
73820143|NCT02081001|147187246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4|STANDARD_ERROR_OF_MEAN|5.4||0.0005|TWO_SIDED|95.0|-30.1|-8.7|||Mixed Models Analysis|||||-8.7|-30.1|0.0005
73820144|NCT02081001|147187246|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.3|STANDARD_ERROR_OF_MEAN|5.4|<|0.0001|TWO_SIDED|95.0|-34.0|-12.6|||Mixed Models Analysis|||||-12.6|-34.0|<0.0001
73820145|NCT02081001|147187247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|1.6||0.22|TWO_SIDED|95.0|-5.1|1.2|||Mixed Models Analysis|||||1.2|-5.1|0.22
73820146|NCT02081001|147187247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.6||0.58|TWO_SIDED|95.0|-4.0|2.3|||Mixed Models Analysis|||||2.3|-4.0|0.58
73820147|NCT02081001|147187247|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|1.6||0.03|TWO_SIDED|95.0|-6.7|-0.4|||Mixed Models Analysis|||||-0.4|-6.7|0.03
73820148|NCT04274075|147187264|OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.945|1.12|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.12|0.945|
73820149|NCT04274075|147187264|OTHER||Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.726|0.859|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.859|0.726|
73820150|NCT04274075|147187265|OTHER||Median Difference (Net)|0.525|||||TWO_SIDED|90.0|-0.225|1.5|||||The Hodges-Lehmann estimate of median difference was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.50|-0.225|
73820151|NCT04274075|147187265|OTHER||Median Difference (Net)|1.98|||||TWO_SIDED|90.0|1.26|2.45|||||The Hodges-Lehmann estimate of median difference was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||2.45|1.26|
73820152|NCT04274075|147187268|OTHER||Geometric Mean Ratio|0.971|||||TWO_SIDED|90.0|0.903|1.04|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.04|0.903|
73820153|NCT04274075|147187268|OTHER||Geometric Mean Ratio|0.919|||||TWO_SIDED|90.0|0.855|0.988|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.988|0.855|
73820154|NCT04274075|147187269|OTHER||Geometric Mean Ratio|0.975|||||TWO_SIDED|90.0|0.908|1.05|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.05|0.908|
73820155|NCT04274075|147187269|OTHER||Geometric Mean Ratio|0.918|||||TWO_SIDED|90.0|0.856|0.985|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.985|0.856|
73820156|NCT05816070|147187291|NON_INFERIORITY|The non-inferiority margin is -10% based on the general standard of antibacterial drug. Non-inferiority is established when P\<0.05.||||||0.0137|||||||Chi-squared|||||||0.0137
73820157|NCT00099632|147187354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by ARV regimen and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants between treatment durations (7-day vs. 21 day), pooled over ARV regimens (3TC/ZDV, FTC/TDF, and LPV/r), stratified by ARV regimen and the actual receipt of antenatal ZDV||||0.37
73820158|NCT00099632|147187354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by treatment duration and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants among ARV regimens (3TC/ZDV vs. FTC/TDF vs. LPV/r), pooled over treatment durations 7-day and 21-day, stratified by treatment duration and the actual receipt of antenatal ZDV||||0.091
73820159|NCT00423813|147187359|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Overall Comparison||||0.001
73820160|NCT00423813|147187359|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||Pairwise comparison of Xyrem 4.5g and placebo||||<0.001
73820161|NCT00423813|147187359|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Pairwise comparison of Xyrem 6.0g and placebo||||0.001
73820162|NCT01386944|147187368|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-0.5|||||TWO_SIDED|95.0|-1.0|-0.5||||||||-0.5|-1.0|
73820163|NCT01386944|147187369|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-1.5|||||TWO_SIDED|95.0|-1.5|-1.0||||||||-1.0|-1.5|
73820164|NCT01386944|147187370|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5||||||||-1.5|-2.0|
73820165|NCT01386944|147187371|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5||||||||-1.5|-2.5|
73820166|NCT01386944|147187372|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5||||||||-1.5|-2.5|
73820167|NCT01386944|147187373|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5||||||||-1.5|-2.0|
73820168|NCT03883477|147187379|OTHER|The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||||0.013||||||1 week P-value|Wilcoxon (Mann-Whitney)|||||||0.013
73820169|NCT03883477|147187379|OTHER|||||||0.007||||||1 month P-value|Wilcoxon (Mann-Whitney)|||The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||0.007
73820170|NCT03883477|147187379|OTHER|||||||0.804||||||6 month P-value|Wilcoxon (Mann-Whitney)|||The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||0.804
73820171|NCT03883477|147187380|OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||||||0.142
73820172|NCT03883477|147187381|OTHER|||||||0.561|||||||Wilcoxon (Mann-Whitney)|||||||0.561
73820173|NCT03883477|147187382|OTHER|||||||0.748|||||||Wilcoxon (Mann-Whitney)|||||||0.748
73820174|NCT03883477|147187383|OTHER|||||||0.184|||||||Wilcoxon (Mann-Whitney)|||||||0.184
73820175|NCT03883477|147187384|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
73820176|NCT03883477|147187385|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
73820177|NCT03658642|147187388|SUPERIORITY||Odds Ratio (OR)|1.22||||0.58|TWO_SIDED|95.0|0.61|2.43|||GEE|Obtained from a GEE model accounting for clustering by site and multiple covariates.||||2.43|0.61|0.58
73820178|NCT03658642|147187389|SUPERIORITY||Odds Ratio (OR)|1.03||||0.95|TWO_SIDED|95.0|0.43|2.47|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.47|0.43|0.95
73820179|NCT03658642|147187391|SUPERIORITY||Odds Ratio (OR)|1.55||||0.01|TWO_SIDED|95.0|1.11|2.16|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.16|1.11|0.01
73820180|NCT03658642|147187392|SUPERIORITY||Odds Ratio (OR)|1.13||||0.48|TWO_SIDED|95.0|0.91|1.57|||GEE|Obtained from a GEE model accounting for clustering by site.||||1.57|0.91|0.48
73820181|NCT03658642|147187393|SUPERIORITY||Odds Ratio (OR)|1.32||||0.27|TWO_SIDED|95.0|0.81|2.14|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.14|0.81|0.27
73820182|NCT02137226|147187399|NON_INFERIORITY_OR_EQUIVALENCE|The 90% Confidence Interval (CI) for ACR20 at Week 12, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region \[-12.0%, 15.0%\]|Difference in proportions|5.9|||||TWO_SIDED|90.0|-0.9|12.7|||Regression, Logistic||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 - Humira, %) is presented.|The week 12 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve||12.7|-0.9|
73820183|NCT02137226|147187400|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is not applicable|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.25|0.05|||ANCOVA||Difference in least square means of BI 695501 - Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 12 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.||0.05|-0.25|
73820184|NCT02137226|147187400|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is not applicable|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.17|0.23|||ANCOVA||Difference in least square means of BI 695501 - Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 24 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.||0.23|-0.17|
73820185|NCT02137226|147187402|NON_INFERIORITY_OR_EQUIVALENCE|The 95% Confidence Interval (CI) for ACR20 at Week 24, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region \[-15.0%;+15.0%\]|Difference in proportions|4.5|||||TWO_SIDED|95.0|-3.4|12.5|||Regression, Logistic||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 - Humira, %) is presented.|The week 24 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve||12.5|-3.4|
73820186|NCT03162328|147187445|SUPERIORITY|||||||0.363|||||||Wilcoxon Signed Ranks Test|||||||0.363
73820187|NCT03162328|147187446|SUPERIORITY|||||||0.291|||||||Wilcoxon Signed Ranks Test|||||||0.291
73820188|NCT00792116|147187461|NON_INFERIORITY_OR_EQUIVALENCE|||||||0.05||95.0|||||ANCOVA|Repeated Measures||||||.05
73820189|NCT00792116|147187462|NON_INFERIORITY_OR_EQUIVALENCE|||||||0.05||95.0|||||ANCOVA|Repeated Measures||||||.05
73820190|NCT00492232|147187463|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.71||||0.484||95.0|0.27|1.85||Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using the logistic regression analysis adjusted for effects of treatment and pooled center.||||1.85|0.27|0.484
73820191|NCT00492232|147187464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.946||95.0|-6.23|5.81||P-values are from t-tests of the analysis of covariance (ANCOVA) model for the difference in least squares (LS) means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||5.81|-6.23|0.946
73820192|NCT00492232|147187465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.901||95.0|-5.31|6.03||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||6.03|-5.31|0.901
73820193|NCT00492232|147187466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.538||95.0|-4.32|8.23||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||8.23|-4.32|0.538
73820194|NCT00492232|147187467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.517||95.0|-9.09|4.6||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||4.60|-9.09|0.517
73820195|NCT00492232|147187468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.965||95.0|-6.28|6.56||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||6.56|-6.28|0.965
73820196|NCT00492232|147187469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.617||95.0|-0.27|0.45||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||0.45|-0.27|0.617
73820197|NCT00492232|147187470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.541||95.0|-0.39|0.74||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||0.74|-0.39|0.541
73820198|NCT00492232|147187471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.163||95.0|-0.23|1.33||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.33|-0.23|0.163
73820199|NCT00492232|147187472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.757||95.0|-0.79|1.08||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.08|-0.79|0.757
73820200|NCT00492232|147187473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.82||95.0|-0.93|1.17||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.17|-0.93|0.820
73820201|NCT00492232|147187475|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.01||||0.284||95.0|0.55|7.34||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs \>10 mg).||||7.34|0.55|0.284
73820202|NCT00492232|147187476|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.42||||0.389||95.0|0.64|3.13||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs \>10 mg).||||3.13|0.64|0.389
73820203|NCT00636636|147187484|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0125|TWO_SIDED|95.0|-0.88|-0.11|||ANCOVA|||||-0.11|-0.88|0.0125
73820204|NCT00636636|147187485|SUPERIORITY_OR_OTHER||Difference in proportion|0.092||||0.0434|TWO_SIDED|95.0|0.0|0.18|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in PGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.||0.18|-0.00|0.0434
73820205|NCT00636636|147187486|SUPERIORITY_OR_OTHER||Difference in proportion|0.102||||0.0268|TWO_SIDED|95.0|0.01|0.19|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in CGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.||0.19|0.01|0.0268
73820206|NCT00636636|147187487|SUPERIORITY_OR_OTHER||Least square mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.18||0.0001|TWO_SIDED|95.0|-1.07|-0.35|||ANCOVA||P-value versus Placebo for pairwise test of difference of LS mean change from baseline between G-ER and Placebo groups is based on t-test of Type III analysis.|||-0.35|-1.07|0.0001
73820207|NCT00636636|147187488|SUPERIORITY_OR_OTHER||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.96|-0.15|||ANCOVA|||||-0.15|-0.96|0.007
73820208|NCT01703169|147187507|OTHER||||||||||||||||||The proportion of platelet response in a previous study (PMID:22762314) was 0.36 (9/25). The null hypothesis of no difference between the platelet response rate in this study and that of the previous study was tested using a two-sided exact test of binomial proportions. A p-value of 0.40 was obtained. The threshold for significance was 0.05.|||
73820209|NCT00905567|147187516|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|93.01||||||90.0|||||||Bioequivalence is established when Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
73820210|NCT00905567|147187517|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.62||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
73820211|NCT00905567|147187518|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.43||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
73820212|NCT02542397|147187519|SUPERIORITY|"It has been reported that, based on the Edmonton Symptom Assessment Scale (ESAS) pain scale, about 30% of cancer patients receiving standard of care pain management experienced \>= 2-point improvement in pain score between visits \[Ref\].~Ref: Scharpf, J., et al., The role of pain in head and neck cancer recurrence and survivorship. Arch Otolaryngol Head Neck Surg, 2009. 135(8): p. 789-94."|Exact binomial proportion|0.5556|||<|0.0001|TWO_SIDED|95.0|0.414|0.6908||The a priori threshold for statistical significance was alpha = 0.10.|Exact binomial test of proportions|||A single-stage design was used to test the hypothesis that the pain improvement rate, assessed by the Edmonton Symptom Assessment Scale, is \<= 0.30. Our study targeted enrollment of 71 evaluable subjects for the final analysis; 54 subjects met the criteria at study closure. Assuming a one-sided alpha=0.10 significance level, 71 evaluable subjects would provide approximately 90% power to reject the null hypothesis (based on an exact binomial test) assuming the true pain improvement rate is 0.45.||.6908|.4140|<0.0001
73820213|NCT02362191|147187562|OTHER|||||||0.758||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.758
73820214|NCT02362191|147187563|OTHER|||||||0.4||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.40
73820215|NCT00947310|147187570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.01|TWO_SIDED|95.0|0.24|0.85|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||0.85|0.24|0.01
73820216|NCT00947310|147187570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.06|TWO_SIDED|95.0|0.3|1.02|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||1.02|0.30|0.06
73820217|NCT00947310|147187571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.39|TWO_SIDED|95.0|0.71|2.47|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||2.47|0.71|0.39
73820218|NCT00947310|147187571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.8|TWO_SIDED|95.0|0.58|2.05|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||2.05|0.58|0.80
73820219|NCT00947310|147187572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.34|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||0.34|0.13|<0.001
73820220|NCT00947310|147187572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.4|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||0.40|0.15|<0.001
73820221|NCT01473940|147187573|OTHER|||||||||||||P-Value not used||||A 3 + 3 enrollment design was adopted to monitor safety and determine the MTD based on DLTs obsesved. The MTD is the highest dose at which 0 of 3 or 1 of 6 DLTs are detected. The MTD is exceeded if 2 of 3 or 2 of 6 DLTs are detected. There will be no dose escalation within a cohort.|The number of DLTs seen at each cohort were used to determine the MTD for the expansion cohort. The MTD was determined to be Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|||
73820222|NCT00547248|147187580|NON_INFERIORITY|Non-inferiority was demonstrated if the difference in terms of incidence of post-immunization febrile reactions (rectal temperature \> 39.0°C) in Synflorix™ vaccine minus Prevenar™ did not exceed the pre-defined clinically acceptable threshold of 5% + half the incidence in Prevenar.|Difference in percentage|0.89|||||TWO_SIDED|95.0|-4.82|5.59|||Philips' statistical test|||||5.59|-4.82|
73896526|NCT03456882|147326400|SUPERIORITY|||||||0.9622||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.9622
73896527|NCT03456882|147326400|SUPERIORITY||Mean Difference (Net)|6.5|STANDARD_ERROR_OF_MEAN|14.3||0.6533|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.6533
73896528|NCT03456882|147326401|SUPERIORITY|||||||0.9137||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.9137
73820223|NCT00534248|147187613|SUPERIORITY_OR_OTHER||point estimate|0.698|||<|0.001|TWO_SIDED|95.0|0.541|0.806|||Conditional Exact Method||The point estimate was for vaccine efficacy with respect to incidence of HZ.|Vaccine efficacy with respect to HZ was defined as the relative reduction in incidence rate of HZ point estimate (95% CI) calculated as 1 minus the ratio of the estimated incidence rates of HZ in the zoster vaccine group and the placebo group.||.806|.541|<.001
73820224|NCT00534248|147187614|SUPERIORITY_OR_OTHER||geometric mean titre ratio|2.3|||<|0.001|TWO_SIDED|95.0|2.2|2.4|||linear mixed longitudinal analysis model|||||2.4|2.2|<.001
73820225|NCT00534248|147187615|SUPERIORITY_OR_OTHER||Relative Risk|1.133|||||TWO_SIDED|95.0|0.805|1.595||||||Analysis of proportion of participants reporting one or more serious adverse experiences reported within 42 days postvaccination.||1.595|.805|
73820226|NCT02259400|147187631|NON_INFERIORITY_OR_EQUIVALENCE|For the calculation of sample size we used the duration of ventilation as the main primary outcome. As no basic data are available for this population, we were able to retrieve from the database of our two NICUs the duration of ventilation on NIV. We assumed a difference of 24-h between the two groups in the duration of NIV as clinically relevant. We used a confidence level α=0.05; the power level desired was 0.80 and consequently we needed 62 patients for each group.|||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
73820227|NCT00112918|147187681|SUPERIORITY_OR_OTHER|||||||0.2024||95.0|||||Closed test procedure|||Adjustments for multiplicity was done using a closed test procedure which tests for differences between all three treatment groups at the 5% alpha level first. Only in case of a significant result, the pair-wise comparison between the control arm and each of the bevacizumab arm will be tested, again at the 5% alpha level.||||0.2024
73820228|NCT02964338|147187687|OTHER||Least square (LS) mean difference|3.5||||0.2741|TWO_SIDED|95.0|-2.8|9.82||Threshold for significance at 0.05 level.|ANCOVA|||||9.82|-2.80|0.2741
73820229|NCT02964338|147187687|OTHER||LS mean difference|-3.3||||0.3047|TWO_SIDED|95.0|-9.59|3.01||Threshold for significance at 0.05 level.|ANCOVA|||||3.01|-9.59|0.3047
73820230|NCT05076604|147187727|SUPERIORITY|||||||0.354|||||||t-test, 2 sided|||Intraoperative packed red blood cell transfusion||||0.354
73820231|NCT05076604|147187727|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||Postoperative red blood cell transfusion||||0.314
73820232|NCT03258645|147187729|OTHER||||||<|0.001|||||||Regression, Linear|||Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of National Institute of Health Stroke Scale (NIHSS) score at index date was applied.||||< 0.001
73820233|NCT03258645|147187730|OTHER|||||||0.01|||||||Regression, Linear|||Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of Modified Rankin Scale (mRS) at index date was applied.||||0.01
73820234|NCT03258645|147187731|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.13||||0.016|TWO_SIDED|95.0|1.02|1.25|||Regression, Linear|Relation between age and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.25|1.02|0.016
73820235|NCT03258645|147187732|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.12||||0.002|TWO_SIDED|95.0|1.04|1.21|||Regression, Linear|Relation between Diastolic blood pressure (DBP) and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.21|1.04|0.002
73820236|NCT03258645|147187733|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.1||||0.04|TWO_SIDED|95.0|1.0|1.21|||Regression, Linear|Relation between CHA2DS2-VASc and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.21|1.00|0.04
73820237|NCT03258645|147187734|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|0.9||||0.051|TWO_SIDED|95.0|0.45|1.0|||Regression, Linear|Relation between HAS-BLED and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.00|0.45|0.051
73820238|NCT03258645|147187735|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|0.91||||0.026|TWO_SIDED|95.0|0.9|0.93|||Regression, Linear|Relation between History/Predisposition To Bleeding and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||0.93|0.9|0.026
73820239|NCT04846270|147187774|OTHER|||||||0.0006|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of manual checks has been reduced.||"POWER is a single arm investigation with cross-over design. Each participating subject will use the study device and act as its own control.~The null hypothesis (H0) is that there is no difference in the mean number of checks performed during the investigation week compared to the baseline week.~The alternate hypothesis (H1) is that there is a reduction in the mean number of checks performed during the investigation week compared to the baseline week."||||0.0006
73820240|NCT04846270|147187776|OTHER|||||||0.0051|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of leakages had been reduced.||||||0.0051
73820241|NCT04846270|147187779|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of fecal incidents had been reduced.||||||0.76
73820242|NCT02488018|147187801|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|99.0|||||ANOVA|Degree of freedom for the model (treatment) was 8.||Hypothesis Ho: Honey plant origin does not affects the glycemic index of human subjects. Ha: Honey plant origin affects the glycemic index of human subjects.||||<0.01
73820243|NCT02373137|147187830|SUPERIORITY||Coefficient|-1.8|||<|0.001|TWO_SIDED|95.0|-2.8|-1.0|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity.|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.8 lines better vision at 6 months.|||-1.0|-2.8|<0.001
73820244|NCT02373137|147187831|SUPERIORITY||Coefficient|-1.5||||0.002|TWO_SIDED|95.0|-2.5|-0.6|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.5 lines better vision at 3 months.|Comparison of 3-Month Visual Acuity Between Groups||-0.6|-2.5|0.002
73820245|NCT02373137|147187831|SUPERIORITY||Coefficient|-1.4|||<|0.001|TWO_SIDED|95.0|-2.2|-0.7|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.4 lines better vision at 12 months.|Comparison of 12 Month Visual Acuity Between Groups||-0.7|-2.2|<0.001
73820246|NCT02373137|147187833|SUPERIORITY||Coefficient|-77.0||||0.53|TWO_SIDED|95.0|-326.0|172.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 3 months.|||172|-326|0.53
73820247|NCT02373137|147187833|SUPERIORITY||Coefficient|-150.0||||0.17|TWO_SIDED|95.0|-356.0|66.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 6 months.|||66|-356|0.17
73820248|NCT02373137|147187833|SUPERIORITY||Coefficient|-215.0||||0.051|TWO_SIDED|95.0|-430.0|-0.4|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 12 months.|||-0.4|-430|0.051
73820249|NCT02373137|147187839|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
73820250|NCT02559570|147187875|SUPERIORITY||Least Squares Mean Difference|-0.042|STANDARD_ERROR_OF_MEAN|0.149||0.7789|TWO_SIDED|95.0|-0.335|0.252|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.252|-0.335|0.7789
73820251|NCT02559570|147187875|SUPERIORITY||Least Squares Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.143||0.993|TWO_SIDED|95.0|-0.282|0.284|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.284|-0.282|0.9930
73820252|NCT02559570|147187875|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.146||0.4107|TWO_SIDED|95.0|-0.167|0.408|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.408|-0.167|0.4107
73820253|NCT02559570|147187876|SUPERIORITY||Least Squares Mean Difference|-0.588|STANDARD_ERROR_OF_MEAN|0.577||0.3097|TWO_SIDED|95.0|-1.729|0.552|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.552|-1.729|0.3097
73820254|NCT02559570|147187876|SUPERIORITY||Least Squares Mean Difference|-0.186|STANDARD_ERROR_OF_MEAN|0.557||0.7384|TWO_SIDED|95.0|-1.286|0.913|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.913|-1.286|0.7384
73820255|NCT02559570|147187876|SUPERIORITY||Least Squares Mean Difference|0.364|STANDARD_ERROR_OF_MEAN|0.563||0.5188|TWO_SIDED|95.0|-0.748|1.477|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||1.477|-0.748|0.5188
73820256|NCT02559570|147187877|SUPERIORITY||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.249||0.8426|TWO_SIDED|95.0|-0.543|0.444|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.444|-0.543|0.8426
73820257|NCT02559570|147187877|SUPERIORITY||Least Squares Mean Difference|-0.038|STANDARD_ERROR_OF_MEAN|0.246||0.877|TWO_SIDED|95.0|-0.525|0.448|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.448|-0.525|0.8770
73820258|NCT02559570|147187877|SUPERIORITY||Least Squares Mean Difference|0.356|STANDARD_ERROR_OF_MEAN|0.246||0.1502|TWO_SIDED|95.0|-0.131|0.842|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.842|-0.131|0.1502
73820259|NCT02559570|147187877|SUPERIORITY||Least Squares Mean Difference|-0.062|STANDARD_ERROR_OF_MEAN|0.239||0.7949|TWO_SIDED|95.0|-0.535|0.41|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.410|-0.535|0.7949
73820260|NCT02559570|147187877|SUPERIORITY||Least Squares Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.235||0.7543|TWO_SIDED|95.0|-0.54|0.392|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.392|-0.540|0.7543
73820261|NCT02559570|147187877|SUPERIORITY||Least Squares Mean Difference|0.262|STANDARD_ERROR_OF_MEAN|0.235||0.2676|TWO_SIDED|95.0|-0.204|0.728|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.728|-0.204|0.2676
73820262|NCT02559570|147187878|SUPERIORITY||Least Squares Mean Difference|-0.053|STANDARD_ERROR_OF_MEAN|0.208||0.7997|TWO_SIDED|95.0|-0.465|0.359|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.359|-0.465|0.7997
73820263|NCT02559570|147187878|SUPERIORITY||Least Squares Mean Difference|-0.121|STANDARD_ERROR_OF_MEAN|0.207||0.5602|TWO_SIDED|95.0|-0.53|0.288|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.288|-0.530|0.5602
73820264|NCT02559570|147187878|SUPERIORITY||Least Squares Mean Difference|-0.236|STANDARD_ERROR_OF_MEAN|0.205||0.2529|TWO_SIDED|95.0|-0.641|0.17|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.170|-0.641|0.2529
73820265|NCT02559570|147187878|SUPERIORITY||Least Squares Mean Difference|-0.054|STANDARD_ERROR_OF_MEAN|0.206||0.7923|TWO_SIDED|95.0|-0.461|0.352|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.352|-0.461|0.7923
73820266|NCT02559570|147187878|SUPERIORITY||Least Squares Mean Difference|-0.113|STANDARD_ERROR_OF_MEAN|0.204||0.5802|TWO_SIDED|95.0|-0.517|0.29|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.290|-0.517|0.5802
73820267|NCT02559570|147187878|SUPERIORITY||Least Squares Mean Difference|-0.199|STANDARD_ERROR_OF_MEAN|0.202||0.3263|TWO_SIDED|95.0|-0.6|0.201|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.201|-0.600|0.3263
73820268|NCT02559570|147187879|SUPERIORITY||Least Squares Mean Difference|0.048|STANDARD_ERROR_OF_MEAN|0.152||0.7507|TWO_SIDED|95.0|-0.252|0.349|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.349|-0.252|0.7507
73820269|NCT02559570|147187879|SUPERIORITY||Least Squares Mean Difference|0.028|STANDARD_ERROR_OF_MEAN|0.146||0.8505|TWO_SIDED|95.0|-0.262|0.317|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.317|-0.262|0.8505
73820270|NCT02559570|147187879|SUPERIORITY||Least Squares Mean Difference|0.039|STANDARD_ERROR_OF_MEAN|0.149||0.7933|TWO_SIDED|95.0|-0.254|0.332|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.332|-0.254|0.7933
73820271|NCT02559570|147187880|SUPERIORITY||Least Squares Mean Difference|-0.425|STANDARD_ERROR_OF_MEAN|0.45||0.3461|TWO_SIDED|95.0|-1.313|0.463|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.463|-1.313|0.3461
73820272|NCT02559570|147187880|SUPERIORITY||Least Squares Mean Difference|-0.235|STANDARD_ERROR_OF_MEAN|0.435||0.5892|TWO_SIDED|95.0|-1.095|0.624|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.624|-1.095|0.5892
73820273|NCT02559570|147187880|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.44||0.856|TWO_SIDED|95.0|-0.789|0.949|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.949|-0.789|0.8560
73820274|NCT04388176|147187882|EQUIVALENCE|Differences in treatment groups in the primary endpoint (log (AUC)) was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|1.0146|||=|0.3801|TWO_SIDED|90.0|0.9859|1.0442|||ANCOVA|||||1.0442|0.9859|=0.3801
73820275|NCT04388176|147187883|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|1.0346|||=|0.0356|TWO_SIDED|90.0|1.0086|1.0613|||ANCOVA|||||1.0613|1.0086|=0.0356
73820276|NCT04388176|147187884|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Difference in least square means|-0.4991|||=|0.0154|TWO_SIDED|90.0|-0.8234|-0.1749|||ANCOVA|||Analysis at the 10 min point||-0.1749|-0.8234|=0.0154
73820277|NCT04388176|147187885|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|0.8301|||=|0.282|TWO_SIDED|90.0|0.6206|1.1102|||ANCOVA|||||1.1102|0.6206|=0.282
73820278|NCT04388176|147187886|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1|Difference in least square means|-0.3989|||=|0.3722|TWO_SIDED|90.0|-1.1718|0.3739|||ANCOVA|||||0.3739|-1.1718|=0.3722
73820279|NCT04388176|147187887|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1|Difference in least square means|-0.109|||=|0.4982|TWO_SIDED|90.0|-0.4074|0.1895|||ANCOVA|||Analysis of capillaroscopy before cold||0.1895|-0.4074|=0.4982
73820280|NCT04388176|147187887|EQUIVALENCE|A difference between treatment groups was detected with a power of 90% and alpha=0.1|Difference in least square means|-0.0637|||=|0.6219|TWO_SIDED|90.0|-0.3037|0.1763|||ANCOVA|||Analysis of capillaroscopy post recovery||0.1763|-0.3037|=0.6219
73820281|NCT00282152|147187913|NON_INFERIORITY|Because the purpose of this trial was to provide preliminary safety and tolerability data, the primary hypothesis was that the DBS+ODT group would not worsen more quickly than the ODT group. The primary endpoint was defined as the time to reach a four-point worsening of the UPDRS-III score following a one week treatment washout as assessed by the blinded rater.||||||0.968|||||||Log Rank|||||||0.968
73820282|NCT00282152|147187914|OTHER|||||||0.4|||||||t-test, 2 sided|||Study power was calculated based on the amount of PD medication consumed. We anticipated that the control group (ODT) would have a baseline value of 400 which would increase to 600, and that the treated group (DBS+ODT) would decrease from 400 to 300. A sample size of 12 patients per group (n=15, assuming 20% drop out) would have 80% power to detect a difference in means of 300 assuming that the common standard deviation is 250 using a two group t-test with a 0.05 two-sided significance level.||||0.40
73820283|NCT01124370|147187960|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The test was conducted using a 0.05 level of significance.|t-test, 2 sided|||The null hypothesis was that there would be no change in AHI from baseline.||||<.001
73820284|NCT01680653|147187993|SUPERIORITY_OR_OTHER|||||||0.106||||||In analyzing prolonged events on remote monitoring versus control, we used x squared analysis or Fisher's exact test to analyze data on 2 x 2 contingency tables. Significance was defined as P\<0.05.|Wilcoxon (Mann-Whitney)|||The study was a feasibility and preliminary safety study. As such, the sample size was not statistically derived and the protocol was not powered to provide for definitive conclusions. The study was limited to 20 participants at each camp session. A hypoglycemic event was defined as at least two consecutive CGM readings (10 mins) below the hypoglycemic threshold of \<70 mg/dL. Recovery from a hypoglycemic event required readings above threshold for \> or = 25 minutes.||||0.106
73820285|NCT01680653|147187994|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.078
73820286|NCT01680653|147187995|SUPERIORITY_OR_OTHER||Fisher's exact test|||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This is the P value for the number of events \<70 mg/dL longer than one hour||||0.003
73820287|NCT01680653|147187995|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Fisher's exact test|||This is the p value for the number of events \<70 mg/dL that were greater than 2 hours||||0.010
73820288|NCT01680653|147187995|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Fisher's exact test|||This is the p value for the number of events that were \<50 mg/dL for \> 30 minutes||||0.021
73820289|NCT01680653|147187995|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||Fisher's exact|||This is the P value for the number of events \<50 mg/dL that were \>1 hr||||0.077
73820290|NCT03020550|147188027|SUPERIORITY|||||||0.034|||||||ANOVA|Adjusted for baseline GERD symptom severity.||The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in GSR (galvanic skin response). No term for visit type assignment was included in the model.||||0.034
73820291|NCT03020550|147188028|SUPERIORITY|||||||0.56|||||||ANOVA|Adjusted for baseline GERD symptom severity||The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in RMSSD (high frequency HRV). No term for visit type assignment was included in the model.||||0.56
73820292|NCT03020550|147188029|SUPERIORITY|||||||0.8|||||||Pearson's correlation test|||The outcome measure was calculated using a Pearson correlation to compare the session index representing the amount of concordance in GSR between patient and physician and the percent change in patients' GERD symptoms. Visit type assignment was not included in the analysis.||||0.80
73820293|NCT00828061|147188055|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.25||||0.002||95.0|0.12|0.54||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.54|0.12|0.002
73820294|NCT00828061|147188055|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.07|||<|0.001||95.0|0.03|0.15||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.15|0.03|<0.001
73820295|NCT00828061|147188056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.537||95.0|-15.48|17.26||1-sided, alpha = 0.05|ANOVA|||||17.26|-15.48|0.537
73820296|NCT01400906|147188057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||||TWO_SIDED|95.0|-0.037|0.38|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.380|-0.037|
73820297|NCT01400906|147188057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|||||TWO_SIDED|95.0|-0.047|0.37|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.370|-0.047|
73820298|NCT01400906|147188062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.638|||||TWO_SIDED|95.0|0.44|0.836|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.836|0.440|
73820299|NCT01400906|147188062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.661|||||TWO_SIDED|95.0|0.463|0.859|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.859|0.463|
73820300|NCT01400906|147188063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|||||TWO_SIDED|95.0|0.018|0.333|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.333|0.018|
73820301|NCT01400906|147188063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|||||TWO_SIDED|95.0|0.008|0.323|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.323|0.008|
73820302|NCT01400906|147188064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.476|||||TWO_SIDED|95.0|0.326|0.627|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.627|0.326|
73820303|NCT01400906|147188064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53|||||TWO_SIDED|95.0|0.38|0.68|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.680|0.380|
73820304|NCT02384538|147188086|OTHER||LS Mean Difference|1.52||||0.386|TWO_SIDED|95.0|-1.944|4.99||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||||4.990|-1.944|0.386
73820305|NCT02384538|147188088|OTHER||LS Mean Difference|2.55||||0.383|TWO_SIDED|95.0|-3.214|8.308||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||8.308|-3.214|0.383
73820306|NCT02384538|147188089|OTHER||LS Mean Difference|0.15||||0.719|TWO_SIDED|95.0|-0.677|0.979||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||0.979|-0.677|0.719
73820307|NCT02384538|147188090|OTHER||LS Mean Difference|4.25||||0.387|TWO_SIDED|95.0|-5.448|13.945||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||13.945|-5.448|0.387
73820308|NCT02384538|147188091|OTHER||LS Mean Difference|0.45||||0.281|TWO_SIDED|95.0|-0.373|1.272||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||1.272|-0.373|0.281
73820309|NCT02384538|147188092|OTHER||LS Mean Difference|0.52||||0.212|TWO_SIDED|95.0|-0.3|1.336||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||1.336|-0.300|0.212
73820310|NCT02872909|147188093|SUPERIORITY||Mean Difference (Final Values)|1.37|||<|0.05|TWO_SIDED|95.0|0.71|2.54||calculated as \<0.05 for 85% power|t-test, 2 sided|Analysed on log transformed data||Sample size requirement estimation - Preliminary data showed pain scores of 1.25 with ambulatory PDT (n=12) and 5.26 (SD 2.38) for conventional PDT (n=50). Estimated that for 85% power to detect as significant at 5% level a difference in mean pain score in one group of 2cm compared with 4 cm in the other group, assuming two-sided testing, a minimum of 45 subjects needed. We aimed for 50 subjects, with an allocation ratio of 2 (twice as many randomised to ambulatory PDT as conventional PDT)||2.54|0.71|<0.05
73820311|NCT02872909|147188096|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
73820312|NCT03280056|147188125|SUPERIORITY||Odds Ratio (OR)|1.33||||0.453|TWO_SIDED|95.0|0.632|2.798|||Chi-squared|||||2.798|0.632|0.453
73820313|NCT03280056|147188126|SUPERIORITY||Odds Ratio (OR)|0.998||||0.997|TWO_SIDED|95.0|0.416|2.395|||Chi-squared|||||2.395|0.416|0.997
73820314|NCT03280056|147188127|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.926||0.693|TWO_SIDED|95.0|-1.47|2.2|||Mixed Models Analysis|||||2.20|-1.47|0.693
73820315|NCT03280056|147188128|SUPERIORITY||Mean Difference (Final Values)|1.53|STANDARD_ERROR_OF_MEAN|6.176||0.804|TWO_SIDED|95.0|-10.65|13.72|||ANCOVA|||||13.72|-10.65|0.804
73820316|NCT02144077|147188129|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin of -15%|Difference in Percentage|1.6|||<|0.0001|ONE_SIDED|97.5|-6.5||||Farrington and Manning Test|Difference of proportions|||||-6.5|<0.0001
73820317|NCT00169104|147188155|SUPERIORITY||Mean Difference (Net)|-0.2|||>|0.05|TWO_SIDED|||||t=-0.29|t-test, 2 sided|df=15||T test||||>0.05
73820318|NCT00809094|147188179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.14|TWO_SIDED|95.0|-0.07|0.48|||t-test, 2 sided|||Null hypothesis: there will be no difference in the change in human neutrophil activity measured from baseline to end of the study (24 weeks)||0.48|-0.07|0.14
73820319|NCT00397189|147188186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|STANDARD_DEVIATION|47.0|<|0.05|TWO_SIDED|95.0|-25.3|-6.0|||ANCOVA|||The analysis was a comparison of sleep latency as measured by the sleep diary at Visit 3 in the ITT 65-80 population, using a linear regression model with terms for treatment (Circadin® 2mg vs. Placebo) and baseline sleep latency.||-6|-25.3|<0.05
73820320|NCT02620683|147188188|OTHER||Median Difference (Final Values)|-15.0||||0.006|TWO_SIDED|95.0|-34.6|-5.86|||Wilcoxon (Mann-Whitney)||for a cross over design difference in blood level was calculate buffered lidocaine minus non-buffered lidocaine|The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||-5.86|-34.6|0.006
73820321|NCT02620683|147188189|OTHER||Mean Difference (Final Values)|-0.66||||0.096|TWO_SIDED|95.0|-1.46|0.13|||t-test, 2 sided|||The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using ProcTTEST (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||0.13|-1.46|0.096
73820322|NCT02620683|147188190|OTHER||Median Difference (Final Values)|-1.0||||0.23|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||1|-4|0.23
73820323|NCT01535443|147188192|OTHER|||||||0.374|||||||Traza Pillai|The test was performed with degrees of freedom: 2||||||.374
73820324|NCT00141518|147188223|SUPERIORITY_OR_OTHER||mean change from baseline|-9.4|STANDARD_DEVIATION|17.5||0.017|TWO_SIDED||||||Wilcoxon tests|||Total Score, Change From Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.017
73820325|NCT00141518|147188224|SUPERIORITY_OR_OTHER||mean change from baseline|0.02|STANDARD_DEVIATION|0.29||0.919|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.919
73820326|NCT00141518|147188225|SUPERIORITY_OR_OTHER||mean change from baseline|0.18|STANDARD_DEVIATION|0.24||0.002|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.002
73820327|NCT00141518|147188252|SUPERIORITY_OR_OTHER||mean change from baseline|-6.5|STANDARD_DEVIATION|9.6||0.001|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 0 (n=27)||||0.001
73820328|NCT00141518|147188252|SUPERIORITY_OR_OTHER||mean change from baseline|-9.2|STANDARD_DEVIATION|9.0|<|0.001|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 3 (n=23)||||<0.001
73820329|NCT00141518|147188252|SUPERIORITY_OR_OTHER||mean change from baseline|-5.9|STANDARD_DEVIATION|11.2||0.022|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 6 (n=24)||||0.022
73820330|NCT00141518|147188252|SUPERIORITY_OR_OTHER||mean change from baseline|-7.5|STANDARD_DEVIATION|11.6||0.005|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 9 (n=23)||||0.005
73820331|NCT00141518|147188252|SUPERIORITY_OR_OTHER||mean change from baseline|-5.3|STANDARD_DEVIATION|13.9||0.126|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=23)||||0.126
73820332|NCT00141518|147188252|SUPERIORITY_OR_OTHER||mean change from baseline|-5.2|STANDARD_DEVIATION|12.3||0.049|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 18 (n=22)||||0.049
73820333|NCT00141518|147188252|SUPERIORITY_OR_OTHER||mean change from baseline|-3.1|STANDARD_DEVIATION|9.9||0.203|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 24 (n=21)||||0.203
73820334|NCT00141518|147188252|SUPERIORITY_OR_OTHER||mean change from baseline|0.8|STANDARD_DEVIATION|13.2||0.733|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 30 (n=21)||||0.733
73820335|NCT00141518|147188252|SUPERIORITY_OR_OTHER||mean change from baseline|4.4|STANDARD_DEVIATION|14.3||0.414|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 36 (n=20)||||0.414
73820336|NCT00141518|147188252|SUPERIORITY_OR_OTHER||mean change from baseline|2.3|STANDARD_DEVIATION|14.9||0.534|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Endpoint (n=27)||||0.534
73820337|NCT00141518|147188261|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.016
73820338|NCT00141518|147188261|SUPERIORITY_OR_OTHER|||||||0.188|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.188
73820339|NCT00141518|147188262|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.008
73820340|NCT00141518|147188262|SUPERIORITY_OR_OTHER|||||||0.107|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.107
73820341|NCT00141518|147188263|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.002
73820342|NCT00141518|147188263|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.010
73820343|NCT00141518|147188264|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.048
73820344|NCT00141518|147188264|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.003
73820345|NCT00141518|147188265|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.001
73820346|NCT00141518|147188265|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.003
73820347|NCT00141518|147188266|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||1.000
73820348|NCT00141518|147188266|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.002
73820349|NCT00141518|147188267|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.017
73820350|NCT00141518|147188267|SUPERIORITY_OR_OTHER|||||||0.191|||||||Wilcoxon tests|||||||0.191
73820351|NCT00141518|147188268|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.002
73820352|NCT00141518|147188268|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||<0.001
73820353|NCT00141518|147188269|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.047
73820354|NCT00141518|147188269|SUPERIORITY_OR_OTHER|||||||0.847|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.847
73820355|NCT00141518|147188270|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.012
73820356|NCT00141518|147188270|SUPERIORITY_OR_OTHER|||||||0.035|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.035
73820357|NCT00141518|147188271|SUPERIORITY_OR_OTHER|||||||0.599|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.599
73820358|NCT00141518|147188271|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.048
73820359|NCT00141518|147188272|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.026
73820360|NCT00141518|147188272|SUPERIORITY_OR_OTHER|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.208
73820361|NCT00141518|147188273|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.010
73820362|NCT00141518|147188273|SUPERIORITY_OR_OTHER|||||||0.073|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.073
73820363|NCT00141518|147188274|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.048
73820364|NCT00141518|147188274|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.030
73820365|NCT00141518|147188275|SUPERIORITY_OR_OTHER|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.208
73820366|NCT00141518|147188275|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.048
73820367|NCT01806168|147188284|OTHER|||||||0.046|||||||Mixed Models Analysis|||||||0.046
73820368|NCT01806168|147188284|EQUIVALENCE|a \< 0.05||||||0.021|||||||t-test, 2 sided|||||||0.021
73820369|NCT01806168|147188284|EQUIVALENCE|a \< 0.05||||||0.65|||||||t-test, 2 sided|||||||0.65
73820370|NCT01806168|147188285|OTHER|||||||0.93|||||||Mixed Models Analysis|||To test primary and secondary outcomes, we utilized intention to treat data and linear mixed models with a group random effect. Significance was set to a \< 0.05.||||0.93
73820371|NCT01806168|147188286|OTHER|||||||0.18|||||||Mixed Models Analysis|||||||0.18
73820372|NCT01806168|147188287|OTHER|||||||0.54|||||||Mixed Models Analysis|||||||0.54
73820373|NCT01806168|147188288|OTHER|||||||0.86|||||||Mixed Models Analysis|||||||0.86
73820374|NCT01806168|147188289|OTHER|||||||0.4|||||||Mixed Models Analysis|||||||0.4
73820375|NCT01029262|147188294|SUPERIORITY||Risk Ratio (RR)|10.616|||<|0.001|TWO_SIDED|95.0|2.639|42.702|||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group||||42.702|2.639|<0.001
73820376|NCT01029262|147188295|SUPERIORITY|||||||1|||||||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.||||||1.000
73820377|NCT01029262|147188296|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0|||<|0.001|TWO_SIDED|95.0|0.0||NA for risk ratio is due to 0 responder in placebo group.|P-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact||||||0|< 0.001
73820378|NCT01029262|147188297|SUPERIORITY|||||||0.639|TWO_SIDED||||||Log Rank|p-value from log-rank test to compare lenalidomide and placebo.||||||0.639
73820379|NCT01029262|147188298|SUPERIORITY||Risk Ratio (RR)|1.276||||0.252|TWO_SIDED|95.0|0.867|1.877||p-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact|||||1.877|0.867|0.252
73820380|NCT01029262|147188300|SUPERIORITY|||||||0.864|TWO_SIDED|||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank|||||||0.864
73820381|NCT01029262|147188301|SUPERIORITY|||||||0.98||||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank|||||||0.980
73820382|NCT01029262|147188303|SUPERIORITY|||||||0.823|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Baseline||||0.823
73820383|NCT01029262|147188303|SUPERIORITY|||||||0.371|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 12 (±3 days)||||0.371
73820384|NCT01029262|147188303|SUPERIORITY|||||||0.391|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 24 (±3 days)||||0.391
73820385|NCT01029262|147188303|SUPERIORITY|||||||1|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 36 (±3 days)||||1.000
73820386|NCT01029262|147188303|SUPERIORITY|||||||0.508|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 48 (±3 days)||||0.508
73820387|NCT01029262|147188304|SUPERIORITY|||||||0.323|TWO_SIDED||||||ANOVA|P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.||Week 12||||0.323
73820388|NCT01029262|147188304|SUPERIORITY|||||||0.071|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.071
73820389|NCT01029262|147188305|SUPERIORITY|||||||0.76|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score|ANOVA|||Week 12||||0.760
73820390|NCT01029262|147188305|SUPERIORITY|||||||0.251|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.251
73820391|NCT01029262|147188306|SUPERIORITY|||||||0.424|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.424
73820392|NCT01029262|147188306|SUPERIORITY|||||||0.116|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.116
73820393|NCT01029262|147188307|SUPERIORITY|||||||0.746|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.746
73820394|NCT01029262|147188307|SUPERIORITY|||||||0.46|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||||||0.460
73820395|NCT01029262|147188308|SUPERIORITY|||||||0.265|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.265
73820396|NCT01029262|147188308|SUPERIORITY|||||||0.047|TWO_SIDED|||||3\]: P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.047
73820397|NCT01029262|147188309|SUPERIORITY|||||||0.2909|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12||||0.2909
73820398|NCT01029262|147188309|SUPERIORITY|||||||0.0759|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.0759
73820399|NCT01029262|147188310|SUPERIORITY|||||||0.6957|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 12||||0.6957
73820400|NCT01029262|147188310|SUPERIORITY|||||||0.1729|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 24||||0.1729
73820401|NCT01029262|147188311|SUPERIORITY|||||||0.3975|TWO_SIDED||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments.||Week 12||||0.3975
73820402|NCT01029262|147188311|SUPERIORITY|||||||0.1714|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.1714
73820403|NCT01029262|147188312|SUPERIORITY|||||||0.6408|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12||||0.6408
73820404|NCT01029262|147188312|SUPERIORITY|||||||0.575|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.5750
73820405|NCT01029262|147188313|SUPERIORITY|||||||0.2848|TWO_SIDED||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments||Week 12||||0.2848
73820406|NCT01029262|147188313|SUPERIORITY|||||||0.1053|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 1 sided|||Week 24||||0.1053
73820407|NCT01029262|147188314|SUPERIORITY|||||||0.042|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.042
73820408|NCT01029262|147188314|SUPERIORITY|||||||0.448|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.448
73820409|NCT01029262|147188315|SUPERIORITY|||||||0.825|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.825
73820410|NCT01029262|147188315|SUPERIORITY|||||||0.568|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.568
73820411|NCT01029262|147188316|SUPERIORITY|||||||0.119|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.119
73820412|NCT01029262|147188316|SUPERIORITY|||||||0.172|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.172
73820413|NCT01029262|147188317|SUPERIORITY|||||||0.792|TWO_SIDED|||||The P-values were calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.792
73820414|NCT01029262|147188317|SUPERIORITY|||||||0.279|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.279
73820415|NCT01029262|147188318|SUPERIORITY|||||||0.476|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.476
73820416|NCT01029262|147188318|SUPERIORITY|||||||0.052|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.052
73820417|NCT01029262|147188319|SUPERIORITY||Risk Ratio (RR)|1.759||||0.017|TWO_SIDED|95.0|1.083|2.856||p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.|Fisher Exact|||||2.856|1.083|0.017
73820418|NCT03410992|147188323|SUPERIORITY||Odds Ratio (OR)|496.318|||<|0.001|TWO_SIDED|95.0|82.798|2975.086||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||2975.086|82.798|<0.001
73820419|NCT03410992|147188324|SUPERIORITY||Odds Ratio (OR)|657.255|||<|0.001|TWO_SIDED|95.0|105.792|4083.333||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||4083.333|105.792|<0.001
73820420|NCT03410992|147188325|SUPERIORITY||Odds Ratio (OR)|220.038|||<|0.001|TWO_SIDED|95.0|28.757|1683.639||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||1683.639|28.757|<0.001
73820421|NCT03410992|147188326|SUPERIORITY||Odds Ratio (OR)|224.744|||<|0.001|TWO_SIDED|95.0|30.13|1676.425||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||1676.425|30.130|<0.001
73820422|NCT03410992|147188327|SUPERIORITY||Odds Ratio (OR)|316.641|||<|0.001|TWO_SIDED|95.0|39.423|2543.254||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||2543.254|39.423|<0.001
73820423|NCT03410992|147188328|SUPERIORITY||Odds Ratio (OR)|34.325|||<|0.001|TWO_SIDED|95.0|14.22|82.856||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||82.856|14.220|<0.001
73820424|NCT03410992|147188329|SUPERIORITY||Odds Ratio (OR)|43.497|||<|0.001|TWO_SIDED|95.0|15.728|120.295||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||120.295|15.728|<0.001
73820425|NCT03410992|147188330|SUPERIORITY||Odds Ratio (OR)|60.946|||<|0.001|TWO_SIDED|95.0|20.56|180.669||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haensze (CMH) test with region and prior biologic exposure as stratification variables.||180.669|20.560|<0.001
73820426|NCT03410992|147188331|SUPERIORITY||Odds Ratio (OR)|158.0|||<|0.001|TWO_SIDED|95.0|49.263|506.745||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||506.745|49.263|<0.001
73820427|NCT03410992|147188332|SUPERIORITY||Odds Ratio (OR)|45.192|||<|0.001|TWO_SIDED|95.0|18.622|109.672||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||109.672|18.622|<0.001
73820428|NCT03410992|147188332|SUPERIORITY||Odds Ratio (OR)|49.297|||<|0.001|TWO_SIDED|95.0|18.887|128.673||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||128.673|18.887|<0.001
73820429|NCT03410992|147188332|SUPERIORITY||Odds Ratio (OR)|47.406|||<|0.001|TWO_SIDED|95.0|22.087|101.75||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||101.750|22.087|<0.001
73820430|NCT03299101|147188368|SUPERIORITY|||||||0.872|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in grip strength across all 4 time points.||||0.872
73820431|NCT03299101|147188368|SUPERIORITY||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|0.71||0.423|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between baseline and day of surgery.||||0.423
73820432|NCT03299101|147188368|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|2.12||0.853|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between baseline and 90 days postop.||||0.853
73820433|NCT03299101|147188368|SUPERIORITY||Mean Difference (Net)|-1.28|STANDARD_ERROR_OF_MEAN|2.16||0.552|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between day of surgery and 90 days postop.||||0.552
73820434|NCT03299101|147188369|SUPERIORITY|||||||0.256||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in max MIP across all 4 time points.||||0.256
73820435|NCT03299101|147188369|SUPERIORITY||Mean Difference (Net)|4.69|STANDARD_ERROR_OF_MEAN|2.78||0.091|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between baseline and day of surgery.||||0.091
73820436|NCT03299101|147188369|SUPERIORITY||Mean Difference (Net)|6.8|STANDARD_ERROR_OF_MEAN|3.69||0.066|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between baseline and 90 days postop.||||0.066
73820437|NCT03299101|147188369|SUPERIORITY||Mean Difference (Net)|1.86|STANDARD_ERROR_OF_MEAN|3.13||0.552|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between day of surgery and 90 days postop.||||0.552
73820438|NCT03299101|147188370|SUPERIORITY|||||||0.003||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in mean MIP across all 4 time points.||||0.003
73820439|NCT03299101|147188370|SUPERIORITY||Mean Difference (Net)|7.48|STANDARD_ERROR_OF_MEAN|2.48||0.003|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between baseline and day of surgery.||||0.003
73820440|NCT03299101|147188370|SUPERIORITY||Mean Difference (Net)|10.18|STANDARD_ERROR_OF_MEAN|3.61||0.005|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between baseline and 90 days postop.||||0.005
73820441|NCT03299101|147188370|SUPERIORITY||Mean Difference (Net)|2.31|STANDARD_ERROR_OF_MEAN|2.18||0.29|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between day of surgery and 90 days postop.||||0.290
73820442|NCT03299101|147188371|SUPERIORITY|||||||0.009||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in maximal inspiratory pressure across all 4 time points.||||0.009
73820443|NCT03299101|147188371|SUPERIORITY||Mean Difference (Net)|12.61|STANDARD_ERROR_OF_MEAN|4.57||0.006|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between baseline and day of surgery.||||0.006
73820444|NCT03299101|147188371|SUPERIORITY||Mean Difference (Net)|12.79|STANDARD_ERROR_OF_MEAN|5.25||0.015|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between baseline and 90 days postop.||||0.015
73820445|NCT03299101|147188371|SUPERIORITY||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|3.42||0.802|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between day of surgery and 90 days postop.||||0.802
73820446|NCT03299101|147188372|SUPERIORITY|||||||0.01||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in Mean MEP across all 4 time points.||||0.010
73820447|NCT03299101|147188372|SUPERIORITY||Mean Difference (Net)|12.37|STANDARD_ERROR_OF_MEAN|4.35||0.004|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between baseline and day of surgery.||||0.004
73820448|NCT03299101|147188372|SUPERIORITY||Mean Difference (Net)|9.95|STANDARD_ERROR_OF_MEAN|4.9||0.042|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between baseline and 90 days postop.||||0.042
73820449|NCT03299101|147188372|SUPERIORITY||Mean Difference (Net)|-3.77|STANDARD_ERROR_OF_MEAN|3.08||0.221|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.||||0.221
73820450|NCT03299101|147188373|SUPERIORITY|||||||0.814|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in max SMIP across all 4 time points.||||0.814
73820451|NCT03299101|147188373|SUPERIORITY||Mean Difference (Net)|10.5|STANDARD_ERROR_OF_MEAN|30.91||0.734|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between baseline and day of surgery.||||0.734
73820452|NCT03299101|147188373|SUPERIORITY||Mean Difference (Net)|21.07|STANDARD_ERROR_OF_MEAN|22.12||0.341|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between baseline and 90 days postop.||||0.341
73820453|NCT03299101|147188373|SUPERIORITY||Mean Difference (Net)|28.55|STANDARD_ERROR_OF_MEAN|37.61||0.448|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between day of surgery and 90 days postop.||||0.448
73820454|NCT03299101|147188374|SUPERIORITY|||||||0.419|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in mean SMIP across all 4 time points.||||0.419
73820455|NCT03299101|147188374|SUPERIORITY||Mean Difference (Net)|20.91|STANDARD_ERROR_OF_MEAN|27.03||0.439|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between baseline and day of surgery.||||0.439
73820456|NCT03299101|147188374|SUPERIORITY||Mean Difference (Net)|47.67|STANDARD_ERROR_OF_MEAN|26.19||0.069|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between baseline and 90 days postop.||||0.069
73820457|NCT03299101|147188374|SUPERIORITY||Mean Difference (Net)|37.11|STANDARD_ERROR_OF_MEAN|37.96||0.328|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between day of surgery and 90 days postop.||||0.328
73820458|NCT03299101|147188375|SUPERIORITY|||||||0.196|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in serum prealbumin across all 4 time points.||||0.196
73820459|NCT03299101|147188375|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.562|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between baseline and day of surgery.||||0.562
73820460|NCT03299101|147188375|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.25||0.087|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between baseline and 90 days postop.||||0.087
73820461|NCT03299101|147188375|SUPERIORITY||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.226|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between day of surgery and 90 days postop.||||0.226
73820462|NCT03299101|147188376|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in gait speed across all 4 time points.||||0.001
73820463|NCT03299101|147188376|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.04||0.001|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in gait speed between baseline and day of surgery.||||0.001
73820464|NCT03299101|147188376|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests|Linear mixed models estimated within-person change in gait speed between baseline and 90 days postop.||||0.001
73820465|NCT03299101|147188376|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.874|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in gait speed between day of surgery and 90 days postop.||||0.874
73820466|NCT03299101|147188377|SUPERIORITY|||||||0.854|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in SPPB across all 4 time points.||||0.854
73820467|NCT03299101|147188377|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.32||0.298|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between baseline and day of surgery.||||0.298
73820468|NCT03299101|147188377|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.31||0.684|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between baseline and 90 days postop.||||0.684
73820469|NCT03299101|147188377|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.33||0.485|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between day of surgery and 90 days postop.||||0.485
73820470|NCT03299101|147188378|SUPERIORITY|||||||0.067|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in RAI across all 4 time points.||||0.067
73820471|NCT03299101|147188378|SUPERIORITY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|1.22||0.089|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between baseline and day of surgery.||||0.089
73820472|NCT03299101|147188378|SUPERIORITY||Mean Difference (Net)|4.37|STANDARD_ERROR_OF_MEAN|1.6||0.006|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between baseline and 90 days postop.||||0.006
73820473|NCT03299101|147188378|SUPERIORITY||Mean Difference (Net)|1.98|STANDARD_ERROR_OF_MEAN|1.62||0.221|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between day of surgery and 90 days postop.||||0.221
73820474|NCT03299101|147188379|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in SGA across all 4 time points.||||0.860
73820475|NCT03299101|147188379|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.41|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between baseline and day of surgery.||||0.410
73820476|NCT03299101|147188379|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.622|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between baseline and 90 days postop.||||0.622
73820477|NCT03299101|147188379|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.757|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between day of surgery and 90 days postop.||||0.757
73820478|NCT03299101|147188380|SUPERIORITY|||||||0.362|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in 6 Minute Walk Test across all 4 time points.||||0.362
73820479|NCT03299101|147188380|SUPERIORITY||Mean Difference (Net)|25.52|STANDARD_ERROR_OF_MEAN|20.06||0.203|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and day of surgery.||||.203
73820480|NCT03299101|147188380|SUPERIORITY||Mean Difference (Net)|12.7|STANDARD_ERROR_OF_MEAN|13.77||0.357|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<0.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and 90 days postop.||||0.357
73820481|NCT03299101|147188380|SUPERIORITY||Mean Difference (Net)|21.48|STANDARD_ERROR_OF_MEAN|15.4||0.163|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<0.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between day of surgery and 90 days postop.||||0.163
73820482|NCT03299101|147188381|SUPERIORITY|||||||0.068|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change across all 4 time points.||||0.068
73820483|NCT03299101|147188381|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.043|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change between baseline and day of surgery.||||0.043
73820484|NCT03299101|147188381|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.092|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change between baseline and 90 days postop.||||0.092
73820485|NCT03299101|147188381|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.292|TWO_SIDED||||||Mixed Models Analysis|The null hypothesis was rejected a priori if p\<.05.|The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.||||0.292
73820486|NCT03299101|147188382|SUPERIORITY|||||||0.625|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change across both time points.||||0.625
73820487|NCT01100723|147188383|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
73820488|NCT01100723|147188384|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||<0.05
73820489|NCT01100723|147188385|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
73820490|NCT01100723|147188386|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
73820491|NCT01100723|147188387|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with Ca values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
73820492|NCT01100723|147188388|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Proportion of subjects on specified medications were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects on the specified medications was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
73820493|NCT01882803|147188389|OTHER||||||<=|0.0001||||||'\<=' represents '≤'|Exact Binomial Test|The p-value was calculated by 1-sided exact binomial test with the null hypothesis that ORR ≤30%.||ORR was tested against the null (≤30%) by 1-sided exact binomial test at 0.025 level.||||<=0.0001
73820494|NCT03066778|147188399|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.00069|TWO_SIDED|95.0|0.6|0.88|||Log Rank|One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH|||0.88|0.60|0.00069
73820495|NCT03066778|147188400|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.01643|TWO_SIDED|95.0|0.64|0.98|||Log Rank|One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH|||0.98|0.64|0.01643
73820496|NCT03066778|147188401|SUPERIORITY||Percent Difference|8.9||||0.0227|TWO_SIDED|95.0|0.2|17.4|||Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.|Based on Miettinen \& Nurminen method stratified by platinum chemotherapy, ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size|||17.4|0.2|0.02270
73820497|NCT03066778|147188406|OTHER||Difference in Least Square Means|4.43||||0.04|TWO_SIDED|95.0|0.21|8.66|||Log Rank|||||8.66|0.21|0.040
73820498|NCT03066778|147188409|OTHER||Hazard Ratio (HR)|0.8||||0.208|TWO_SIDED|95.0|0.56|1.14|||Log Rank|Two-sided p-value based on stratified log-rank test|Based on Cox regression model with treatment as a covariate stratified by platinum chemotherapy ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size|||1.14|0.56|0.208
73820499|NCT03665077|147188419|OTHER|Linear mixed-effect model of log-transformed oxylipin level, with time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.684|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.684
73820500|NCT03665077|147188420|OTHER|Linear mixed-effect model of log-transformed oxylipin level, with time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.02|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.02
73820501|NCT03665077|147188421|OTHER|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.058|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.058
73820502|NCT00435461|147188426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||||-0.7|-1.2|<0.001
73820503|NCT00435461|147188426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||||-0.7|-1.2|<0.001
73820504|NCT00435461|147188426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.816|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|||||0.2|-0.3|0.816
73820505|NCT00435461|147188427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.6|-0.9|||ANCOVA|||||-0.9|-1.6|<0.001
73820506|NCT00435461|147188427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||||-0.7|-1.4|<0.001
73820507|NCT00435461|147188427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.136|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.136
73820508|NCT00435461|147188428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.5|-0.7|||ANCOVA|||||-0.7|-1.5|<0.001
73820509|NCT00435461|147188428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|<0.001
73820510|NCT00435461|147188428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.136|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.136
73820511|NCT00435461|147188429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.6|-0.8|||ANCOVA|||||-0.8|-1.6|<0.001
73820512|NCT00435461|147188429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.3|-0.6|||ANCOVA|||||-0.6|-1.3|<0.001
73820513|NCT00435461|147188429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.136|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.136
73820514|NCT00435461|147188430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.001
73820515|NCT00435461|147188430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0|-0.6|0.106
73820516|NCT00435461|147188430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
73820517|NCT00435461|147188431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.007|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.007
73820518|NCT00435461|147188431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
73820519|NCT00435461|147188431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.106
73820520|NCT00435461|147188432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.003|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|||||-0.2|-0.7|0.003
73820521|NCT00435461|147188432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
73820522|NCT00435461|147188432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0|-0.6|0.106
73820523|NCT00435461|147188433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.7|-1.0|||ANCOVA|||Pre-dose iTNSS||-1|-1.7|<0.001
73820524|NCT00435461|147188433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||Pre-dose iTNSS||-0.7|-1.4|<0.001
73820525|NCT00435461|147188433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.193|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Pre-dose iTNSS||0.1|-0.6|0.193
73820526|NCT00435461|147188433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||Pre-dose iTOSS||-0.2|-0.8|<0.001
73820527|NCT00435461|147188433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.058|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Pre-dose iTOSS||0|-0.6|0.058
73820528|NCT00435461|147188433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.16|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||Pre-dose iTOSS||0|-0.5|0.16
73820529|NCT00435461|147188434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.7|11.9|||ANCOVA|||Morning assessment||11.9|5.7|<0.001
73820530|NCT00435461|147188434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.3|11.5|||ANCOVA|||Morning assessment||11.5|5.3|<0.001
73820531|NCT00435461|147188434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.59||0.779|TWO_SIDED|95.0|-3.6|2.7|||ANCOVA|||Morning assessment||2.7|-3.6|0.779
73820532|NCT00435461|147188434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|3.1|9.6|||ANCOVA|||Evening assessment||9.6|3.1|<0.001
73820533|NCT00435461|147188434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|3.8|10.3|||ANCOVA|||Evening assessment||10.3|3.8|<0.001
73820534|NCT00435461|147188434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.65||0.662|TWO_SIDED|95.0|-2.5|4.0|||ANCOVA|||Evening assessment||4|-2.5|0.662
73820535|NCT00435461|147188435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.001
73820536|NCT00435461|147188435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.203|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.203
73820537|NCT00435461|147188435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.8|-0.4|||ANCOVA|||||-0.4|-0.8|<0.001
73820538|NCT00205660|147188436|SUPERIORITY|||||||0.03||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).||||0.03
73820539|NCT00205660|147188437|SUPERIORITY|||||||0.01||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).||||0.01
73820540|NCT00237692|147188440|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.8|||||TWO_SIDED|95.0|55.7|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||63.9|55.7|
73820541|NCT00237692|147188440|SUPERIORITY_OR_OTHER||Est. % of patients with controled SBP|59.8|||||TWO_SIDED|95.0|55.7|64.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||64.0|55.7|
73820542|NCT00237692|147188440|SUPERIORITY_OR_OTHER||Est. % of patinets with controlled SBP|59.8|||||TWO_SIDED|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled BP at Baseline||63.9|55.6|
73820543|NCT00237692|147188440|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.8|||||TWO_SIDED|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||63.9|55.6|
73820544|NCT00237692|147188441|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|58.0|||||TWO_SIDED|95.0|49.3|66.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 6 months.||66.7|49.3|
73820545|NCT00237692|147188441|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|60.9|||||TWO_SIDED|95.0|52.5|69.3|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||69.3|52.5|
73820546|NCT00237692|147188441|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|65.0|||||TWO_SIDED|95.0|56.9|73.1|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||73.1|56.9|
73820547|NCT00237692|147188441|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|63.8|||||TWO_SIDED|95.0|55.6|72.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||72.0|55.6|
73820548|NCT00237692|147188441|SUPERIORITY_OR_OTHER||% diff|2.9|||||TWO_SIDED|95.0|-9.0|14.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 6months.||14.9|-9.0|
73820549|NCT00237692|147188441|SUPERIORITY_OR_OTHER||% Diff|6.9|||||TWO_SIDED|95.0|-4.7|18.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Med Management and Arm 1 - Control at 6months.||18.7|-4.7|
73820550|NCT00237692|147188441|SUPERIORITY_OR_OTHER||% Diff|5.7|||||TWO_SIDED|95.0|-6.0|17.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 6months.||17.6|-6.0|
73820551|NCT00237692|147188442|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.9|||||TWO_SIDED|95.0|51.4|68.3|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.||68.3|51.4|
73820552|NCT00237692|147188442|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|73.1|||||TWO_SIDED|95.0|65.6|80.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months||80.7|65.6|
73820553|NCT00237692|147188442|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|73.4|||||TWO_SIDED|95.0|66.1|80.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.||80.7|66.1|
73820554|NCT00237692|147188442|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|68.6|||||TWO_SIDED|95.0|60.5|76.6|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 12 months.||76.6|60.5|
73820555|NCT00237692|147188442|SUPERIORITY_OR_OTHER||% Diff|13.2|||||TWO_SIDED|95.0|2.0|24.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 12 months.||24.4|2.0|
73820556|NCT00237692|147188442|SUPERIORITY_OR_OTHER||% Diff|13.5|||||TWO_SIDED|95.0|2.4|24.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 12 months.||24.6|2.4|
73820557|NCT00237692|147188442|SUPERIORITY_OR_OTHER||% diff|8.6|||||TWO_SIDED|95.0|-2.9|20.2||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 12 months.||20.2|-2.9|
73820558|NCT00237692|147188443|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|61.8|||||TWO_SIDED|95.0|53.0|70.6|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 18 months||70.6|53.0|
73820559|NCT00237692|147188443|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.4|||||TWO_SIDED|95.0|50.8|67.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled BP at 18 months||67.9|50.8|
73820560|NCT00237692|147188443|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|63.5|||||TWO_SIDED|95.0|55.1|72.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months.||72.0|55.1|
73820561|NCT00237692|147188443|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|71.6|||||TWO_SIDED|95.0|63.7|79.5|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months||79.5|63.7|
73820562|NCT00237692|147188443|SUPERIORITY_OR_OTHER||% Diff|-2.4|||||TWO_SIDED|95.0|-14.6|9.7||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 18 months.||9.7|-14.6|
73820563|NCT00237692|147188443|SUPERIORITY_OR_OTHER||% Diff|1.7|||||TWO_SIDED|95.0|-10.3|13.8||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 18 months.||13.8|-10.3|
73820564|NCT00237692|147188443|SUPERIORITY_OR_OTHER||% Diff|9.8|||||TWO_SIDED|95.0|-1.9|21.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 18 months.||21.4|-1.9|
73820565|NCT00237692|147188445|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|2.0|||||TWO_SIDED|95.0|-3.1|7.1|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral||7.1|-3.1|
73820566|NCT00237692|147188445|SUPERIORITY_OR_OTHER||Est. Dif in Patient w/Controlled DBP|0.5|||||TWO_SIDED|95.0|-2.7|3.8|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral||3.8|-2.7|
73820567|NCT00237692|147188445|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|0.4|||||TWO_SIDED|95.0|-4.8|5.5|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nurse Med Management.||5.5|-4.8|
73820568|NCT00237692|147188445|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled DBP|0.7|||||TWO_SIDED|95.0|-2.6|4.0|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nuse Med Management||4.0|-2.6|
73820569|NCT00237692|147188445|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|1.6|||||TWO_SIDED|95.0|-3.3|6.6|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management||6.6|-3.3|
73820570|NCT00237692|147188445|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled DBP|3.4|||||TWO_SIDED|95.0|0.3|6.6|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management||6.6|0.3|
73820571|NCT02420262|147188446|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for IDegLira vs basal-bolus (IGlar + IAsp) was considered confirmed if the upper boundary of the two-sided 95% confidence interval was strictly below 0.30% or equivalent for non-inferiority using one-sided test for null hypothesis (H0): D ≥0.30% against alternative hypothesis (HA): D \<0.30% was less than or equal to 2.5%, where D is the mean treatment difference (IDegLira minus basal-bolus).|Treatment contrast|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.16|0.12|||Mixed Models Analysis|||Change from baseline in HbA1c was analysed using a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline HbA1c as covariate. Interactions between visit and all factors and the covariate were also included in the model.||0.12|-0.16|<0.0001
73820572|NCT02420262|147188447|SUPERIORITY_OR_OTHER||Treatment ratio|0.11|||<|0.0001|TWO_SIDED|95.0|0.08|0.17|||Negative binomial regression model||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment rate ratio was entirely below 1.0.|Hypoglycaemic episodes were analysed using a negative binomial regression. The model included treatment and region as fixed factors and logarithm of the time period in which a hypoglycaemic episode considered treatment emergent as offset. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.||0.17|0.08|<0.0001
73820573|NCT02420262|147188448|SUPERIORITY_OR_OTHER||Treatment difference|-3.57|||<|0.0001|TWO_SIDED|95.0|-4.19|-2.95|||Mixed Models Analysis||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment difference was below 0 or equal to zero.|Body weight measurements were analysed using a linear mixed model with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline bodyweight as covariate. Interactions between visit and all factors and the covariate were also included in the model. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.||-2.95|-4.19|<0.0001
73820574|NCT01850394|147188460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|180.0|STANDARD_DEVIATION|300.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
73820575|NCT01850394|147188460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|150.0|STANDARD_DEVIATION|200.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
73820576|NCT01850394|147188461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|140.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
73820577|NCT01850394|147188461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|4.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
73820578|NCT01850394|147188462|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
73820579|NCT01850394|147188463|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
73820580|NCT01850394|147188464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|STANDARD_DEVIATION|1.0||0.05|TWO_SIDED|95.0|||||ANOVA|||||||0.05
73820581|NCT05446142|147188472|OTHER||Reference/Test Ratio|95.25|||||TWO_SIDED|90.0|90.82|99.9||||||Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||99.90|90.82|
73820582|NCT05446142|147188472|OTHER||Reference/Test Ratio|96.3|||||TWO_SIDED|90.0|91.71|101.12||||||Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||101.12|91.71|
73820583|NCT05446142|147188472|OTHER||Reference/Test Ratio|96.57|||||TWO_SIDED|90.0|82.91|112.47||||||Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||112.47|82.91|
73820584|NCT05446142|147188472|OTHER||Reference/Test Ratio|88.56|||||TWO_SIDED|90.0|82.59|94.95||||||Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||94.95|82.59|
73820585|NCT05446142|147188473|OTHER||Reference/Test Ratio|104.31|||||TWO_SIDED|90.0|91.4|119.04||||||Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||119.04|91.40|
73820586|NCT05446142|147188473|OTHER||Reference/Test Ratio|90.35|||||TWO_SIDED|90.0|79.17|103.12||||||Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||103.12|79.17|
73820587|NCT05446142|147188473|OTHER||Reference/Test Ratio|79.66|||||TWO_SIDED|90.0|58.7|108.08||||||Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||108.08|58.70|
73820588|NCT05446142|147188473|OTHER||Reference/Test Ratio|80.78|||||TWO_SIDED|90.0|64.82|100.68||||||Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||100.68|64.82|
73820589|NCT05446142|147188474|OTHER||Reference/Test Ratio|95.34|||||TWO_SIDED|90.0|90.37|100.59||||||Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||100.59|90.37|
73820590|NCT05446142|147188474|OTHER||Reference/Test Ratio|94.67|||||TWO_SIDED|90.0|89.73|99.88||||||Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||99.88|89.73|
73820591|NCT05446142|147188474|OTHER||Reference/Test Ratio|95.76|||||TWO_SIDED|90.0|84.1|109.04||||||Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||109.04|84.10|
73820592|NCT05446142|147188474|OTHER||Reference/Test Ratio|88.31|||||TWO_SIDED|90.0|82.36|94.7||||||Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||94.70|82.36|
73820593|NCT02098395|147188483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.2|||Mixed Models Analysis|||Superiority of liraglutide 1.8 mg versus placebo was planned to be concluded if and only if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c was less than zero.||-0.2|-0.5|< 0.0001
73820594|NCT02098395|147188483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||=|0.0021|TWO_SIDED|95.0|-0.38|-0.08|||Mixed Models Analysis|||Superiority of liraglutide 1.2 mg was planned to be evaluated only if superiority for liraglutide 1.8 mg was concluded.||-0.08|-0.38|= 0.0021
73820595|NCT02098395|147188483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|||=|0.0011|TWO_SIDED|95.0|-0.39|-0.1|||Mixed Models Analysis|||Superiority of liraglutide 0.6 mg versus placebo was planned to be evaluated only if superiority of liraglutide 1.2 mg was concluded.||-0.1|-0.39|= 0.0011
73820596|NCT01151345|147188537|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|88.65|||||TWO_SIDED|90.0|81.23|96.75||||||Natural-log transformed AUC (0-t) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||96.75|81.23|
73820597|NCT01151345|147188538|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|91.26|||||TWO_SIDED|90.0|83.83|99.34||||||Natural-log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||99.34|83.83|
73820598|NCT01151345|147188539|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|83.25|||||TWO_SIDED|90.0|67.08|103.31||||||Natural-log transformed Cmax was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||103.31|67.08|
73820599|NCT01129804|147188561|SUPERIORITY|Longitudinal Linear mixed modeling|Slope|0.1|||<|0.04|TWO_SIDED|||||Tested the null hypothesis that slopes of PDA over time would not differ between treatment conditions, as indicated by the significance of the Treatment main effect and Treatment X Time interaction effect, at the level of p \< .05.|Mixed Models Analysis||||Multilevel longitudinal modeling (MLM) with random effects and maximum likelihood estimation (Proc MIXED; SAS Institute, 1999) was used to evaluate the effects of treatment over time for each of the continuously scaled outcome variables described above. The MLM approach was used because it employs maximum likelihood estimation of covariance matrices rather than raw data, allowing us to take advantage of all data collected for anyone randomized to treatment. Each repeated dependent variable was analyzed as a unction of treatment condition, time since intake (in months), and the interaction of treatment condition by time.|||<.04
73820600|NCT03828214|147188600|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|9.2||0.973|TWO_SIDED|||||a priori threshold for statistical significance was 0.05.|ANOVA|||C2, C3, C4 were compared to C1 the comparison condition.||||0.973
73820601|NCT00305565|147188604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.803|TWO_SIDED|95.0|-2.34|3.02|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.||3.02|-2.34|0.803
73820602|NCT00305565|147188604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.813|TWO_SIDED|95.0|-2.39|3.05|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.||3.05|-2.39|0.813
73820603|NCT02182830|147188665|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the primary endpoint|Adjusted mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.2||0.0002|TWO_SIDED|95.0|-1.18|-0.38|||Mixed Models Analysis||Empagliflozin minus Placebo|"MMRM model : HbA1c baseline, treatment, renal function, pre-treatment with metformin, visit, visit by treatment interaction, and HbA1c baseline by treatment interaction. Treatment, renal function, pre-treatment with metformin, visit, and visit by treatment interaction were fixed classification effects, and HbA1c baseline was a linear covariate. The interaction visit by HbA1c baseline interaction was based on the linear covariate HbA1c baseline."||-0.38|-1.18|0.0002
73820604|NCT02182830|147188666|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.21|STANDARD_ERROR_OF_MEAN|2.04||0.0117|TWO_SIDED|95.0|-9.24|-1.18|||ANCOVA||Empagliflozin minus Placebo|"change from baseline in mean 24-hour ambulatory SBP at 12 weeks of treatment was evaluated by using an Analysis of Covariance (ANCOVA) model.~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."||-1.18|-9.24|0.0117
73820605|NCT02182830|147188667|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.99|STANDARD_ERROR_OF_MEAN|2.62||0.0237|TWO_SIDED|95.0|-11.16|-0.81|||ANCOVA||Empagliflozin minus Placebo|"ANCOVA mode:~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."||-0.81|-11.16|0.0237
73820606|NCT02182830|147188668|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.59||0.0382|TWO_SIDED|95.0|-2.39|-0.07|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.||-0.07|-2.39|0.0382
73820607|NCT02182830|147188669|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-4.04|STANDARD_ERROR_OF_MEAN|2.59||0.1215|TWO_SIDED|95.0|-9.16|1.09|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.||1.09|-9.16|0.1215
73820608|NCT02182830|147188670|SUPERIORITY||Adjusted mean difference|-8.39|STANDARD_ERROR_OF_MEAN|2.69||0.0025|TWO_SIDED|95.0|-13.74|-3.04|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-3.04|-13.74|0.0025
73820609|NCT02182830|147188671|SUPERIORITY||Adjusted mean difference|-3.43|STANDARD_ERROR_OF_MEAN|1.25||0.0069|TWO_SIDED|95.0|-5.9|-0.96|||ANCOVA||Empagliflozin minus Placebo|The respective ANCOVA model includes treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the respective secondary endpoint.||-0.96|-5.90|0.0069
73820610|NCT02182830|147188672|SUPERIORITY||Adjusted mean difference|-4.91|STANDARD_ERROR_OF_MEAN|1.74||0.0058|TWO_SIDED|95.0|-8.35|-1.46|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-1.46|-8.35|0.0058
73820611|NCT02182830|147188673|SUPERIORITY||Adjusted mean difference|-7.43|STANDARD_ERROR_OF_MEAN|2.5||0.0036|TWO_SIDED|95.0|-12.37|-2.48|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-2.48|-12.37|0.0036
73820612|NCT02182830|147188674|SUPERIORITY||Adjusted mean difference|-1.84|STANDARD_ERROR_OF_MEAN|1.56||0.2402|TWO_SIDED|95.0|-4.93|1.25|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||1.25|-4.93|0.2402
73820613|NCT02182830|147188675|SUPERIORITY||Adjusted mean difference|-4.25|STANDARD_ERROR_OF_MEAN|1.49||0.0053|TWO_SIDED|95.0|-7.21|-1.29|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-1.29|-7.21|0.0053
73820614|NCT04672044|147188689|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
73820615|NCT03268005|147188695|NON_INFERIORITY|The upper limit of the 95% confidence interval for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4% non-inferiority was considered established and effect demonstrated.|Treatment difference|-0.04||||0.31|TWO_SIDED|95.0|-0.11|0.03|||ANOVA||Faster aspart-NovoRapid|Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, region and metformin use at baseline (Yes/No) as factors, and baseline HbA1c as a covariate.||0.03|-0.11|0.310
73820616|NCT04378569|147188754|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5788|TWO_SIDED|95.0|0.49|2.53|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.53|0.49|0.5788
73820617|NCT04378569|147188754|SUPERIORITY||Odds Ratio (OR)|0.84||||0.6488|TWO_SIDED|95.0|0.33|2.17|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.17|0.33|0.6488
73820618|NCT04378569|147188754|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5653|TWO_SIDED|95.0|0.32|2.25|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.25|0.32|0.5653
73820619|NCT04378569|147188755|SUPERIORITY||Odds Ratio (OR)|0.84||||0.5033|TWO_SIDED|95.0|0.25|2.78|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.78|0.25|0.5033
73820620|NCT04378569|147188755|SUPERIORITY||Odds Ratio (OR)|0.83||||0.4975|TWO_SIDED|95.0|0.25|2.79|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.79|0.25|0.4975
73820621|NCT04378569|147188755|SUPERIORITY||Odds Ratio (OR)|0.33|||||TWO_SIDED|95.0|0.04|2.55||P value was not evaluable|Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.55|0.04|
73820622|NCT04378569|147188756|SUPERIORITY||Odds Ratio (OR)|0.75||||0.7237|TWO_SIDED|95.0|0.23|2.44|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.44|0.23|0.7237
73820623|NCT04378569|147188756|SUPERIORITY||Odds Ratio (OR)|0.59||||0.838|TWO_SIDED|95.0|0.17|2.1|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.10|0.17|0.8380
73820624|NCT04378569|147188756|SUPERIORITY||Odds Ratio (OR)|0.33|||||TWO_SIDED|95.0|0.04|2.55||p-value was unevaluable||Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.55|0.04|
73820625|NCT04378569|147188757|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9604|TWO_SIDED|95.0|0.31|3.07|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.07|0.31|0.9604
73820626|NCT04378569|147188757|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9752|TWO_SIDED|95.0|0.32|3.25|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.25|0.32|0.9752
73820627|NCT04378569|147188757|SUPERIORITY||Odds Ratio (OR)|0.57||||0.5077|TWO_SIDED|95.0|0.11|3.03|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.03|0.11|0.5077
73820628|NCT04378569|147188757|SUPERIORITY||Odds Ratio (OR)|0.74||||0.5916|TWO_SIDED|95.0|0.26|2.15|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||2.15|0.26|0.5916
73820629|NCT04378569|147188757|SUPERIORITY||Odds Ratio (OR)|0.65||||0.332|TWO_SIDED|95.0|0.27|1.57|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||1.57|0.27|0.3320
73820630|NCT04378569|147188757|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1922|TWO_SIDED|95.0|0.14|1.57|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||1.57|0.14|0.1922
73820631|NCT04378569|147188757|SUPERIORITY||Odds Ratio (OR)|0.65||||0.4188|TWO_SIDED|95.0|0.23|1.81|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||1.81|0.23|0.4188
73820632|NCT04378569|147188757|SUPERIORITY||Odds Ratio (OR)|0.74||||0.552|TWO_SIDED|95.0|0.29|1.92|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||1.92|0.29|0.5520
73820633|NCT04378569|147188757|SUPERIORITY||Odds Ratio (OR)|0.69||||0.69|TWO_SIDED|95.0|0.21|2.2|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||2.20|0.21|0.69
73820634|NCT04378569|147188758|SUPERIORITY|Week 2|Mean Difference (Net)|-0.06||||0.6464|TWO_SIDED|95.0|-0.33|0.21|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|||0.21|-0.33|0.6464
73820635|NCT04378569|147188758|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8881|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 2||0.25|-0.29|0.8881
73820636|NCT04378569|147188758|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.436|TWO_SIDED|95.0|-0.2|0.46|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 2||0.46|-0.20|0.4360
73820637|NCT04378569|147188758|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.8196|TWO_SIDED|95.0|-0.29|0.36|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 4||0.36|-0.29|0.8196
73820638|NCT04378569|147188758|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.9217|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 4||0.34|-0.31|0.9217
73820639|NCT04378569|147188758|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.4783|TWO_SIDED|95.0|-0.25|0.53|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|||0.53|-0.25|0.4783
73820640|NCT04378569|147188758|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.7725|TWO_SIDED|95.0|-0.32|0.43|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.43|-0.32|0.7725
73820641|NCT04378569|147188758|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.7861|TWO_SIDED|95.0|-0.43|0.33|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.33|-0.43|0.7861
73820642|NCT04378569|147188758|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.3521|TWO_SIDED|95.0|-0.24|0.68|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.68|-0.24|0.3521
73820643|NCT04378569|147188758|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.2166|TWO_SIDED|95.0|-0.62|0.14|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.14|-0.62|0.2166
73820644|NCT04378569|147188758|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5262|TWO_SIDED|95.0|-0.52|0.27|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.27|-0.52|0.5262
73820645|NCT04378569|147188758|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.7575|TWO_SIDED|95.0|-0.39|0.54|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.54|-0.39|0.7575
73820646|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|1.73||||0.2662|TWO_SIDED|95.0|0.64|4.7|||Cochran-Mantel-Haenszel|Stratified|Stratified|Week 2||4.70|0.64|0.2662
73820647|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|1.54||||0.3798|TWO_SIDED|95.0|0.59|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.00|0.59|0.3798
73820648|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0611|TWO_SIDED|95.0|0.9|11.17|||Cochran-Mantel-Haenszel|||Week 2||11.17|0.90|0.0611
73820649|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3129|TWO_SIDED|95.0|0.64|3.93|||Cochran-Mantel-Haenszel|||Week 4||3.93|0.64|0.3129
73820650|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9586|TWO_SIDED|95.0|0.35|2.74|||Cochran-Mantel-Haenszel|||Week 4||2.74|0.35|0.9586
73820651|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0643|TWO_SIDED|95.0|0.87|15.29|||Cochran-Mantel-Haenszel|||Week 4||15.29|0.87|0.0643
73820652|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0932|TWO_SIDED|95.0|0.84|6.88|||Cochran-Mantel-Haenszel|||Week 8||6.88|0.84|0.0932
73820653|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|1.42||||0.573|TWO_SIDED|95.0|0.44|4.59|||Cochran-Mantel-Haenszel|||Week 8||4.59|0.44|0.5730
73820654|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|4.96||||0.0389|TWO_SIDED|95.0|0.96|25.66|||Cochran-Mantel-Haenszel|||Week 8||25.66|0.96|0.0389
73820655|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2813|TWO_SIDED|95.0|0.6|5.53|||Cochran-Mantel-Haenszel|||Week 12||5.53|0.60|0.2813
73820656|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|0.72||||0.6841|TWO_SIDED|95.0|0.17|3.03|||Cochran-Mantel-Haenszel|||Week 12||3.03|0.17|0.6841
73820657|NCT04378569|147188760|SUPERIORITY||Odds Ratio (OR)|2.13||||0.3113|TWO_SIDED|95.0|0.49|9.21|||Cochran-Mantel-Haenszel|||Week 12||9.21|0.49|0.3113
73820658|NCT04378569|147188763|SUPERIORITY||Odds Ratio (OR)|2.21||||0.2674|TWO_SIDED|95.0|0.46|10.67|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||10.67|0.46|0.2674
73820659|NCT04378569|147188763|SUPERIORITY||Odds Ratio (OR)|2.78||||0.285|TWO_SIDED|95.0|0.44|17.54|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||17.54|0.44|0.2850
73820660|NCT04378569|147188763|SUPERIORITY||Odds Ratio (OR)|2.63||||0.3086|TWO_SIDED|95.0|0.42|16.52|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||16.52|0.42|0.3086
73820661|NCT04378569|147188763|SUPERIORITY||Odds Ratio (OR)|4.33||||0.1655|TWO_SIDED|95.0|0.46|40.83|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||40.83|0.46|0.1655
73820662|NCT04378569|147188763|SUPERIORITY||Odds Ratio (OR)|1.41||||0.7154|TWO_SIDED|95.0|0.26|7.67|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||7.67|0.26|0.7154
73820663|NCT04378569|147188763|SUPERIORITY||Odds Ratio (OR)|2.0||||0.5371|TWO_SIDED|95.0|0.27|14.64|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||14.64|0.27|0.5371
73820664|NCT04378569|147188763|SUPERIORITY||Odds Ratio (OR)|5.0||||0.217|TWO_SIDED|95.0|0.43|57.83|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||57.83|0.43|0.2170
73820665|NCT04378569|147188763|SUPERIORITY||Odds Ratio (OR)|2.74||||0.3408|TWO_SIDED|95.0|0.41|18.22|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||18.22|0.41|0.3408
73820666|NCT04378569|147188763|SUPERIORITY||Odds Ratio (OR)|2.4||||0.327|TWO_SIDED|95.0|0.41|14.2|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||14.20|0.41|0.3270
73820667|NCT04378569|147188763|SUPERIORITY|||||||0.0719|||||||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||||0.0719
73820668|NCT04378569|147188763|SUPERIORITY||Odds Ratio (OR)|0.78||||0.8527|TWO_SIDED|95.0|0.07|8.43|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||8.43|0.07|0.8527
73820669|NCT04378569|147188763|SUPERIORITY||Odds Ratio (OR)|2.2||||0.3545|TWO_SIDED|95.0|0.37|13.11|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||13.11|0.37|0.3545
73820670|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.0725|TWO_SIDED|95.0|-9.2|0.4|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||0.4|-9.2|0.0725
73820671|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-5.8||||0.0183|TWO_SIDED|95.0|-10.7|-1.0|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||-1.0|-10.7|0.0183
73820672|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.5701|TWO_SIDED|95.0|-7.7|4.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables||Week 2||4.3|-7.7|0.5701
73820673|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.2116|TWO_SIDED|95.0|-10.4|2.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||2.3|-10.4|0.2116
73820674|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.1235|TWO_SIDED|95.0|-11.5|1.4|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||1.4|-11.5|0.1235
73820675|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.6334|TWO_SIDED|95.0|-9.7|5.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||5.9|-9.7|0.6334
73820676|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-4.6||||0.1788|TWO_SIDED|95.0|-11.4|2.1|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||2.1|-11.4|0.1788
73820677|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-7.6||||0.0292|TWO_SIDED|95.0|-14.4|-0.8|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||-0.8|-14.4|0.0292
73820678|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-8.8||||0.0371|TWO_SIDED|95.0|-17.1|-0.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||-0.5|-17.1|0.0371
73820679|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.2971|TWO_SIDED|95.0|-11.3|3.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||3.5|-11.3|0.2971
73820680|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-9.5||||0.015|TWO_SIDED|95.0|-17.2|-1.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||-1.9|-17.2|0.0150
73820681|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.1245|TWO_SIDED|95.0|-15.8|1.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||1.9|-15.8|0.1245
73820682|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-5.3||||0.1591|TWO_SIDED|95.0|-12.7|2.1|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||2.1|-12.7|0.1591
73820683|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-7.3||||0.06|TWO_SIDED|95.0|-14.8|0.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||0.3|-14.8|0.0600
73820684|NCT04378569|147188764|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.464|TWO_SIDED|95.0|-12.0|5.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||5.5|-12.0|0.4640
73820685|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|-0.066||||0.3184|TWO_SIDED|95.0|-0.196|0.064|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||0.064|-0.196|0.3184
73820686|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|-0.013||||0.8514|TWO_SIDED|95.0|-0.149|0.123|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 2||0.123|-0.149|0.8514
73820687|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|0.091||||0.2603|TWO_SIDED|95.0|-0.068|0.249|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 2||0.249|-0.068|0.2603
73820688|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|-0.171||||0.0273|TWO_SIDED|95.0|-0.323|-0.019|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||-0.019|-0.323|0.0273
73820689|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0266|TWO_SIDED|95.0|-0.339|-0.021|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||-0.021|-0.339|0.0266
73820690|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.9023|TWO_SIDED|95.0|-0.196|0.173|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||0.173|-0.196|0.9023
73820691|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|-0.096||||0.3298|TWO_SIDED|95.0|-0.291|0.098|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.098|-0.291|0.3298
73820692|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6205|TWO_SIDED|95.0|-0.251|0.15|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.150|-0.251|0.6205
73820693|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|-0.018||||0.8817|TWO_SIDED|95.0|-0.253|0.217|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.217|-0.253|0.8817
73820694|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|-0.122||||0.1837|TWO_SIDED|95.0|-0.302|0.058|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 12||0.058|-0.302|0.1837
73820695|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|-0.102||||0.2896|TWO_SIDED|95.0|-0.293|0.088|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|||0.088|-0.293|0.2896
73820696|NCT04378569|147188765|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.919|TWO_SIDED|95.0|-0.205|0.227|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 12||0.227|-0.205|0.9190
73820697|NCT02256917|147188789|OTHER|Confirmative one-sided one-sample Poisson-test.|ABR|4.87|||||TWO_SIDED|95.0|4.06|5.79||A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean ABR in patients with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|one-sided one-sample Poisson-test||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.96-5.93|||5.79|4.06|
73820698|NCT02256917|147188789|OTHER|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Negative Binomial regression model including a correction for overdispersion.|Rate ratio|11.89|||<|0.0001|TWO_SIDED|95.0|7.5|18.86|||Negative binomial regression model|||||18.86|7.50|<0.0001
73820699|NCT02256917|147188789|OTHER|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Poisson regression model including a correction for overdispersion.|Rate ratio|10.14|||<|0.0001|TWO_SIDED|95.0|6.12|16.8|||Poisson regression model|||||16.80|6.12|<0.0001
73820700|NCT02256917|147188790|OTHER|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean spontaneous ABR in patients with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|3.12|||||TWO_SIDED|95.0|2.48|3.87|||One-sided one-sample Poisso|||||3.87|2.48|
73820701|NCT02256917|147188791|OTHER|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean ABR in patients with 2x/week prophylaxis or less with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|5.03|||||TWO_SIDED|95.0|3.9|6.39|||One-sided one-sample Poisson-test||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.76-6.60|||6.39|3.90|
73820702|NCT01556932|147188845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|3.2541|||TWO_SIDED|||||||||||||
73820703|NCT00996034|147188851|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||This is a comparison of scan 1 and scan 2||||<0.05
73820704|NCT00685360|147188854|SUPERIORITY||Risk Ratio Mean|1.534|||=|0.0083|TWO_SIDED|95.0|1.107|2.124|||Cochran-Mantel-Haenszel|P-value was derived using Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata (cavitation).||||2.124|1.107|=0.0083
73820705|NCT00685360|147188854|SUPERIORITY||Risk Ratio Mean|1.416|||=|0.0393|TWO_SIDED|95.0|1.012|1.98||P-value was derived using CMH test stratified by randomization strata (cavitation).|Cochran-Mantel-Haenszel|||||1.980|1.012|=0.0393
73820706|NCT00685360|147188866|SUPERIORITY||Risk Ratio Mean|1.599|||=|0.0021|TWO_SIDED|95.0|1.175|2.177|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||2.177|1.175|=0.0021
73820707|NCT00685360|147188866|SUPERIORITY||Risk Ratio Mean|1.939|||<|0.0001|TWO_SIDED|95.0|1.449|2.595|||Cochran-Mantel-Haenszel|||||2.595|1.449|<.0001
73820708|NCT00685360|147188867|SUPERIORITY||||||=|0.2419|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from analysis of covariance(ANCOVA)model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.2419
73820709|NCT00685360|147188867|SUPERIORITY||||||=|0.2239|TWO_SIDED||||||ANCOVA|Pairwise comparison is derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.2239
73820710|NCT00685360|147188867|SUPERIORITY||||||=|0.9544|TWO_SIDED||||||ANCOVA|Pairwise comparison is derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.9544
73820711|NCT00685360|147188868|SUPERIORITY||||||=|0.0246|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.0246
73820712|NCT00685360|147188868|SUPERIORITY||||||=|0.0529|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.0529
73820713|NCT00685360|147188868|SUPERIORITY||||||=|0.7508|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.7508
73820714|NCT00685360|147188869|SUPERIORITY||Risk Ratio Mean|1.272|||=|0.0518|TWO_SIDED|95.0|0.995|1.627|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.627|0.995|=0.0518
73820715|NCT00685360|147188869|SUPERIORITY||Risk Ratio Mean|1.203|||=|0.1506|TWO_SIDED|95.0|0.934|1.55|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.550|0.934|=0.1506
73820716|NCT00685360|147188870|SUPERIORITY||Risk Ratio Mean|1.234|||=|0.1201|TWO_SIDED|95.0|0.945|1.612|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.612|0.945|=0.1201
73820717|NCT00685360|147188870|SUPERIORITY||Risk Ratio Mean|1.099|||=|0.5112|TWO_SIDED|95.0|0.829|1.456|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.456|0.829|=0.5112
73820718|NCT00685360|147188871|SUPERIORITY||Risk Ratio Mean|1.323|||=|0.0141|TWO_SIDED|95.0|1.053|1.661|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.661|1.053|=0.0141
73820719|NCT00685360|147188871|SUPERIORITY||Risk Ratio Mean|1.438|||=|0.0008|TWO_SIDED|95.0|1.155|1.791|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.791|1.155|=0.0008
73820720|NCT00685360|147188872|SUPERIORITY||Risk Ratio Mean|1.341|||=|0.0196|TWO_SIDED|95.0|1.044|1.722|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.722|1.044|=0.0196
73820721|NCT00685360|147188872|SUPERIORITY||Risk Ratio Mean|1.503|||=|0.0006|TWO_SIDED|95.0|1.183|1.909|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.909|1.183|=0.0006
73820722|NCT00685360|147188873|SUPERIORITY||||||=|0.0468|||||||Cochran-Armitage Linear Trend Test|Cochran-Armitage test was performed for dose response with the treatment group ordered as placebo, delamanid 100 mg BID, and delamanid 200 mg BID.||||||=0.0468
73820723|NCT00685360|147188874|SUPERIORITY||Hazard Ratio (HR)|1.856|||=|0.0011|TWO_SIDED|95.0|1.255|2.745|||Stratified Log-Rank Test|p-value was derived from log-rank test with SAS Proc lifetest for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.745|1.255|=0.0011
73820724|NCT00685360|147188874|SUPERIORITY||Hazard Ratio (HR)|1.849|||=|0.0013|TWO_SIDED|95.0|1.246|2.743|||Stratified Log-Rank Test|p-value was derived from log-rank test with SAS Proc lifetest for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.743|1.246|=0.0013
73820725|NCT00685360|147188875|SUPERIORITY||Hazard Ratio (HR)|1.926|||=|0.0004|TWO_SIDED|95.0|1.315|2.82|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.820|1.315|=0.0004
73820726|NCT00685360|147188875|SUPERIORITY||Hazard Ratio (HR)|2.19|||<|0.0001|TWO_SIDED|95.0|1.504|3.189|||Stratified Log-Rank Test|||||3.189|1.504|<.0001
73820727|NCT00685360|147188876|SUPERIORITY||Hazard Ratio (HR)|1.727|||=|0.0056|TWO_SIDED|95.0|1.152|2.591|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.591|1.152|=0.0056
73820728|NCT00685360|147188876|SUPERIORITY||Hazard Ratio (HR)|1.585|||=|0.0232|TWO_SIDED|95.0|1.048|2.399|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.399|1.048|=0.0232
73820729|NCT00685360|147188877|SUPERIORITY||Hazard Ratio (HR)|1.846|||=|0.0016|TWO_SIDED|95.0|1.235|2.759|||Stratified Log-Rank Test|P-value was derived from log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.759|1.235|=0.0016
73820730|NCT00685360|147188877|SUPERIORITY||Hazard Ratio (HR)|2.301|||<|0.0001|TWO_SIDED|95.0|1.555|3.405|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||3.405|1.555|<.0001
73820731|NCT00547157|147188903|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.09|||||TWO_SIDED|95.0|-0.26|0.07|||||difference is PRT - CRT|||0.07|-0.26|
73820732|NCT00547157|147188904|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.613||||0.0601|TWO_SIDED|95.0|0.98|2.656|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.|||2.656|0.980|0.0601
73820733|NCT00547157|147188905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.731||||0.0259|TWO_SIDED|95.0|1.068|2.806|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.|||2.806|1.068|0.0259
73820734|NCT00547157|147188906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.593||||0.1039|TWO_SIDED|95.0|0.909|2.793|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy|||2.793|0.909|0.1039
73820735|NCT00547157|147188907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.791||||0.5744|TWO_SIDED|95.0|0.342|1.785|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.|||1.785|0.342|0.5744
73820736|NCT00547157|147188907|SUPERIORITY_OR_OTHER||Difference in objective response rate|-0.044|||||TWO_SIDED|95.0|-0.187|0.112|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.|||0.112|-0.187|
73820737|NCT00547157|147188908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.278||||0.807|TWO_SIDED|95.0|0.438|4.043|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.|||4.043|0.438|0.8070
73820738|NCT00547157|147188908|SUPERIORITY_OR_OTHER||Difference in complete response rate|0.029|||||TWO_SIDED|95.0|-0.103|0.141|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.|||0.141|-0.103|
73820739|NCT01765569|147188922|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.82|||||TWO_SIDED|90.0|1.63|2.02||||||||2.02|1.63|
73820740|NCT01765569|147188926|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.47|||||TWO_SIDED|90.0|1.3|1.65||||||||1.65|1.3|
73820741|NCT04208412|147188930|SUPERIORITY|||||||0.001|||||||Wilcoxon Test (Gehan's Generalized)|||||||0.0010
73820742|NCT04208412|147188931|SUPERIORITY|||||||0.0045|||||||Prescott's Test|||||||0.0045
73820743|NCT04208412|147188932|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||"Gehan's Generalized Wilcoxon Test:~600 mg KVD900 vs Placebo"||||<0.0001
73820744|NCT04208412|147188933|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||||||<0.0001
73820745|NCT04208412|147188934|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||||||<0.0001
73820746|NCT05415462|147188940|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H1N1 strain at a 2-sided 0.025 level.|Geometric Mean Ratio (GMR)|1.01|||||TWO_SIDED|97.5|0.952|1.071||||||GMR (mRNA-1010 vs Fluarix) for Influenza A H1N1 Antibody||1.071|0.952|
73820747|NCT05415462|147188940|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H3N2 strain at a 2-sided 0.025 level.|GMR|1.657|||||TWO_SIDED|97.5|1.562|1.757||||||GMR (mRNA-1010 vs Fluarix) for Influenza A H3N2 Antibody||1.757|1.562|
73820748|NCT05415462|147188940|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Victoria-lineage strain at a 2-sided 0.025 level.|GMR|0.665|||||TWO_SIDED|97.5|0.63|0.702||||||GMR (mRNA-1010 vs Fluarix) for Influenza B/ Victoria Lineage||0.702|0.630|
73820749|NCT05415462|147188940|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Yamagata-lineage strain at a 2-sided 0.025 level.|GMR|0.661|||||TWO_SIDED|97.5|0.63|0.693||||||GMR (mRNA-1010 vs Fluarix) for Influenza B/ Yamagata Lineage||0.693|0.630|
73820750|NCT05415462|147188941|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H1N1 strain at a 2-sided 0.025 level.|Percentage Difference|5.75|||||TWO_SIDED|97.5|3.12|8.38||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza A H1N1 Antibody||8.38|3.12|
73820751|NCT05415462|147188941|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H3N2 strain at a 2-sided 0.025 level.|Percentage Difference|16.91|||||TWO_SIDED|97.5|14.27|19.54||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza A H3N2 Antibody||19.54|14.27|
73820752|NCT05415462|147188941|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Victoria-lineage strain at a 2-sided 0.025 level.|Percentage Difference|-17.34|||||TWO_SIDED|97.5|-20.22|-14.43||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza B/Victoria Lineage||-14.43|-20.22|
73820753|NCT05415462|147188941|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Yamagata-lineage strain at a 2-sided 0.025 level.|Percentage Difference|-15.68|||||TWO_SIDED|97.5|-18.57|-12.76||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza B/Yamagata Lineage||-12.76|-18.57|
73820754|NCT02259699|147188950|SUPERIORITY|||||||0.582|||||||t-test, 2 sided|||Difference between arms at T1||||0.582
73820755|NCT02259699|147188950|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||Difference between arms at T3||||0.053
73820756|NCT02259699|147188950|SUPERIORITY|||||||0.288|||||||t-test, 2 sided|||Difference between arms at T4||||0.288
73820757|NCT02259699|147188951|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||Difference between arms at T3||||0.087
73820758|NCT02259699|147188951|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Difference between arms at T4||||0.910
73820759|NCT02259699|147188952|SUPERIORITY|||||||0.807|||||||t-test, 2 sided|||||||0.807
73820760|NCT02259699|147188953|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||Difference between arms at T3||||0.071
73820761|NCT02259699|147188953|SUPERIORITY|||||||0.332|||||||t-test, 2 sided|||Difference between arms at T4||||0.332
73820762|NCT02259699|147188954|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||Difference between arms at T3||||0.177
73820763|NCT02259699|147188954|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||Difference between arms at T4||||0.745
73820764|NCT01904032|147188963|SUPERIORITY||Mean Difference (Final Values)|0.7982|STANDARD_ERROR_OF_MEAN|2.0537||0.6982|TWO_SIDED|95.0|-3.2691|4.8656|||t-test, 2 sided|||The null hypothesis is that there is no difference in the CES-D change score between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||4.8656|-3.2691|.6982
73820765|NCT01904032|147188964|SUPERIORITY||Mean Difference (Final Values)|-0.0424|STANDARD_ERROR_OF_MEAN|3.6619||0.9908|TWO_SIDED|95.0|-7.2946|7.2097|||t-test, 2 sided|||The null hypothesis is that there is no difference in the PAID change score between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||7.2097|-7.2946|.9908
73820766|NCT01904032|147188965|SUPERIORITY||Mean Difference (Final Values)|0.4966|STANDARD_ERROR_OF_MEAN|3.1474||0.8749|TWO_SIDED|95.0|-5.7366|6.7298|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change in systolic blood pressure between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||6.7298|-5.7366|.8749
73820767|NCT01904032|147188966|SUPERIORITY||Mean Difference (Final Values)|1.5125|STANDARD_ERROR_OF_MEAN|1.8636||0.4187|TWO_SIDED|95.0|-2.1784|5.2033|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change in diastolic blood pressure between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||5.2033|-2.1784|.4187
73820768|NCT02432209|147188987|SUPERIORITY||Risk Ratio (RR)|0.81||||0.404|TWO_SIDED|95.0|0.48|1.34|||Chi-squared|||||1.34|0.48|0.404
73820769|NCT01087203|147188994|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.53||0.025|TWO_SIDED|95.0|-2.28|-0.16|||ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.16|-2.28|0.025
73820770|NCT01087203|147188995|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.332|TWO_SIDED|95.0|-0.92|0.32|||ANCOVA|||Week 1: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||0.32|-0.92|0.332
73820771|NCT01087203|147188995|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.38||0.297|TWO_SIDED|95.0|-1.15|0.36|||ANCOVA|||Week 2: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||0.36|-1.15|0.297
73820772|NCT01087203|147188995|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.42||0.029|TWO_SIDED|95.0|-1.81|-0.1|||ANCOVA|||Week 4: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.10|-1.81|0.029
73820773|NCT01087203|147188995|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.46||0.01|TWO_SIDED|95.0|-2.17|-0.3|||ANCOVA|||Week 6: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.30|-2.17|0.010
73820774|NCT01087203|147188995|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.49||0.009|TWO_SIDED|95.0|-2.3|-0.34|||ANCOVA|||Week 8: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.34|-2.30|0.009
73820775|NCT01087203|147188995|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|0.52||0.015|TWO_SIDED|95.0|-2.36|-0.27|||ANCOVA|||Week 12: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.27|-2.36|0.015
73820776|NCT00502853|147189102|SUPERIORITY_OR_OTHER|||||||0.1776|||||||Student's t-test|||Change from Baseline to Week 4||||0.1776
73820777|NCT00502853|147189102|SUPERIORITY_OR_OTHER|||||||0.1215|||||||Student's t-test|||Change from Baseline to Week 24||||0.1215
73820778|NCT00502853|147189102|SUPERIORITY_OR_OTHER||Slope|-0.1606|STANDARD_ERROR_OF_MEAN|0.1231||0.2246|||||||Random coefficient model|||Trend over time||||0.2246
73820779|NCT00502853|147189103|SUPERIORITY_OR_OTHER|||||||0.8989|||||||Student's t-test|||Change from Baseline to Week 4||||0.8989
73820780|NCT00502853|147189103|SUPERIORITY_OR_OTHER|||||||0.8834|||||||Student's t-test|||Change from Baseline to Week 24||||0.8834
73820781|NCT00502853|147189103|SUPERIORITY_OR_OTHER||Slope|0.1357|STANDARD_ERROR_OF_MEAN|0.9051||0.8841|||||||Random coefficient model|||Trend over time||||0.8841
73820782|NCT00502853|147189104|SUPERIORITY_OR_OTHER|||||||0.5911|||||||Student's t-test|||Change from Baseline to Week 4||||0.5911
73820783|NCT00502853|147189104|SUPERIORITY_OR_OTHER|||||||0.1475|||||||Student's t-test|||Change from Baseline to Week 24||||0.1475
73820784|NCT00502853|147189104|SUPERIORITY_OR_OTHER||Slope|0.1786|STANDARD_ERROR_OF_MEAN|0.1123||0.1463|||||||Random coefficient model|||Trend over time||||0.1463
73820785|NCT00502853|147189105|SUPERIORITY_OR_OTHER|||||||0.1101|||||||Student's t-test|||Change from Baseline at Week 4||||0.1101
73820786|NCT00502853|147189105|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Student's t-test|||Change from Baseline at Week 12||||0.0003
73820787|NCT00502853|147189105|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24||||0.0018
73820788|NCT00502853|147189105|SUPERIORITY_OR_OTHER||Slope|-2.0857|STANDARD_ERROR_OF_MEAN|0.4965||0.0023|||||||Random coefficient model|||Trend over time||||0.0023
73820789|NCT00502853|147189106|SUPERIORITY_OR_OTHER|||||||0.3358|||||||Student's t-test|||Change from Baseline at Week 4||||0.3358
73820790|NCT00502853|147189106|SUPERIORITY_OR_OTHER|||||||0.9158|||||||Student's t-test|||Change from Baseline at Week 24||||0.9158
73820791|NCT00502853|147189106|SUPERIORITY_OR_OTHER||Slope|0.003418|STANDARD_ERROR_OF_MEAN|0.02345||0.8877|||||||Random coefficient model|||Trend over time||||0.8877
73820792|NCT00502853|147189107|SUPERIORITY_OR_OTHER|||||||0.7624|||||||Student's t-test|||Change from Baseline at Week 4||||0.7624
73820793|NCT00502853|147189107|SUPERIORITY_OR_OTHER|||||||0.0212|||||||Student's t-test|||Change from Baseline at Week 24||||0.0212
73820794|NCT00502853|147189107|SUPERIORITY_OR_OTHER||Slope|-4.2681|STANDARD_ERROR_OF_MEAN|2.0529||0.0712|||||||Random coefficient model|||Trend over time||||0.0712
73820795|NCT00502853|147189108|SUPERIORITY_OR_OTHER|||||||0.024|||||||Student's t-test|||Change from Baseline at Week 4||||0.0240
73820796|NCT00502853|147189108|SUPERIORITY_OR_OTHER|||||||0.0045|||||||Student's t-test|||Change from Baseline at Week 12||||0.0045
73820797|NCT00502853|147189108|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24||||0.0018
73820798|NCT00502853|147189108|SUPERIORITY_OR_OTHER||Slope|-0.1964|STANDARD_ERROR_OF_MEAN|0.04524||0.0019|||||||Random Coefficient Model|||Trend over time||||0.0019
73820799|NCT00502853|147189109|SUPERIORITY_OR_OTHER||Slope|-6.6294|STANDARD_ERROR_OF_MEAN|1.8623||0.0074|||||||Random Coefficient Model|||Trend over time||||0.0074
73820800|NCT00502853|147189109|SUPERIORITY_OR_OTHER|||||||0.1273|||||||Student's t-test|||Change from Baseline at Week 4||||0.1273
73820801|NCT00502853|147189109|SUPERIORITY_OR_OTHER|||||||0.0132|||||||Student's t-test|||Change from Baseline at Week 12||||0.0132
73820802|NCT00502853|147189109|SUPERIORITY_OR_OTHER|||||||0.1542|||||||Student's t-test|||Change from Baseline at Week 24||||0.1542
73820803|NCT00502853|147189110|SUPERIORITY_OR_OTHER|||||||0.1396|||||||Student's t-test|||Change from Baseline at Week 4||||0.1396
73820804|NCT00502853|147189110|SUPERIORITY_OR_OTHER|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 12||||0.0050
73820805|NCT00502853|147189110|SUPERIORITY_OR_OTHER|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 24||||0.0050
73820806|NCT00502853|147189110|SUPERIORITY_OR_OTHER||Slope|-0.2902|STANDARD_ERROR_OF_MEAN|0.07966||0.0054|||||||Random coefficient model|||Trend over time||||0.0054
73820807|NCT00502853|147189111|SUPERIORITY_OR_OTHER|||||||0.0254|||||||Student's t-test|||Change from Baseline at Week 4||||0.0254
73820808|NCT00502853|147189111|SUPERIORITY_OR_OTHER|||||||0.0384|||||||Student's t-test|||Change from Baseline at Week 12||||0.0384
73820809|NCT00502853|147189111|SUPERIORITY_OR_OTHER|||||||0.0271|||||||Student's t-test|||Change from Baseline at Week 24||||0.0271
73820810|NCT00502853|147189111|SUPERIORITY_OR_OTHER||Slope|-4.7586|STANDARD_ERROR_OF_MEAN|1.5278||0.0124|||||||Random coefficient model|||Trend over time||||0.0124
73820811|NCT00502853|147189112|SUPERIORITY_OR_OTHER|||||||0.7376|||||||Student's t-test|||Change from Baseline at Week 4||||0.7376
73820812|NCT00502853|147189112|SUPERIORITY_OR_OTHER|||||||0.1631|||||||Student's t-test|||Change from Baseline at Week 12||||0.1631
73820813|NCT00502853|147189112|SUPERIORITY_OR_OTHER|||||||0.8816|||||||Student's t-test|||Change from Baseline at Week 24||||0.8816
73820814|NCT00502853|147189112|SUPERIORITY_OR_OTHER||Slope|-0.2927|STANDARD_ERROR_OF_MEAN|1.9408||0.8835|||||||Random coefficient model|||Trend over time||||0.8835
73820815|NCT00502853|147189113|SUPERIORITY_OR_OTHER|||||||0.1312|||||||Student's t-test|||Change from Baseline at Week 4||||0.1312
73820816|NCT00502853|147189113|SUPERIORITY_OR_OTHER|||||||0.0662|||||||Student's t-test|||Change from Baseline at Week 12||||0.0662
73820817|NCT00502853|147189113|SUPERIORITY_OR_OTHER|||||||0.4133|||||||Student's t-test|||Change from Baseline at Week 24||||0.4133
73820818|NCT00502853|147189113|SUPERIORITY_OR_OTHER||Slope|8.8196|STANDARD_ERROR_OF_MEAN|16.4534||0.6049|||||||Random coefficient model|||Trend over time||||0.6049
73820819|NCT00502853|147189114|SUPERIORITY_OR_OTHER|||||||0.1725|||||||Student's t-test|||Change from Baseline at Week 4||||0.1725
73820820|NCT00502853|147189114|SUPERIORITY_OR_OTHER|||||||0.0832|||||||Student's t-test|||Change from Baseline at Week 12||||0.0832
73820821|NCT00502853|147189114|SUPERIORITY_OR_OTHER|||||||0.1685|||||||Student's t-test|||Change from Baseline at Week 24||||0.1685
73820822|NCT00502853|147189114|SUPERIORITY_OR_OTHER||Slope|-55.4458|STANDARD_ERROR_OF_MEAN|33.5821||0.1331|||||||Random coefficient model|||Trend over time||||0.1331
73820823|NCT00502853|147189115|SUPERIORITY_OR_OTHER|||||||0.2938|||||||Student's t-test|||Change from Baseline at Week 4||||0.2938
73820824|NCT00502853|147189115|SUPERIORITY_OR_OTHER|||||||0.2216|||||||Student's t-test|||Change from Baseline at Week 12||||0.2216
73820825|NCT00502853|147189115|SUPERIORITY_OR_OTHER|||||||0.567|TWO_SIDED||||||Student's t-test|||Change from Baseline at Week 24||||0.5670
73820826|NCT00502853|147189116|SUPERIORITY_OR_OTHER|||||||0.0934|||||||Student's t-test|||Change from Baseline at Week 4||||0.0934
73820827|NCT00502853|147189116|SUPERIORITY_OR_OTHER|||||||0.4047|||||||Student's t-test|||Change from Baseline at Week 12||||0.4047
73820828|NCT00502853|147189116|SUPERIORITY_OR_OTHER|||||||0.2101|||||||Student's t-test|||Change from Baseline at Week 24||||0.2101
73820829|NCT00502853|147189116|SUPERIORITY_OR_OTHER||Slope|0.3997|STANDARD_ERROR_OF_MEAN|0.2506||0.1451|||||||Random coefficient model|||Trend over time||||0.1451
73820830|NCT00502853|147189117|SUPERIORITY_OR_OTHER|||||||0.4963|||||||Student's t-test|||Change from Baseline at Week 4||||0.4963
73820831|NCT00502853|147189117|SUPERIORITY_OR_OTHER|||||||0.2198|||||||Student's t-test|||Change from Baseline at Week 12||||0.2198
73820832|NCT00502853|147189117|SUPERIORITY_OR_OTHER|||||||0.6773|||||||Student's t-test|||Change from Baseline at Week 24||||0.6773
73820833|NCT00502853|147189117|SUPERIORITY_OR_OTHER||Slope|0.3688|STANDARD_ERROR_OF_MEAN|0.5987||0.5531|||||||Random coefficient model|||Trend over time||||0.5531
73820834|NCT00502853|147189118|SUPERIORITY_OR_OTHER|||||||0.5002|||||||Student's t-test|||Change from Baseline at Week 24||||0.5002
73820835|NCT00502853|147189119|SUPERIORITY_OR_OTHER|||||||1|||||||Student's t-test|||Change from Baseline at Week 24||||1.0000
73820836|NCT00502853|147189120|SUPERIORITY_OR_OTHER|||||||0.7002|||||||Student's t-test|||Change from Baseline at Week 24||||0.7002
73820837|NCT00502853|147189121|SUPERIORITY_OR_OTHER|||||||0.3132|||||||Student's t-test|||Change from Baseline at Week 24||||0.3132
73820838|NCT00502853|147189122|SUPERIORITY_OR_OTHER|||||||0.8597|||||||Student's t-test|||Change from Baseline at Week 24||||0.8597
73820839|NCT00502853|147189123|SUPERIORITY_OR_OTHER|||||||0.3617|||||||Student's t-test|||Change from Baseline at Week 24||||0.3617
73820840|NCT01868165|147189126|OTHER||Slope|0.58|||||TWO_SIDED|95.0|-0.6|1.77|||||"Linear regression slope and 95% confidence intervals for the association between calcium channel blocker use and cognitive change was 0.58 (-0.60:1.77).~Multiple adjustments including; age, sex, education."|||1.77|-0.60|
73820841|NCT03373461|147189230|OTHER|||||||0.038|||||||Multiple Comparison Procedure-Modeling|||||||0.038
73820842|NCT03373461|147189230|OTHER||Ratio to placebo (of ratio to baseline)|0.99|||||TWO_SIDED|80.0|0.86|1.0||||||||1.00|0.86|
73820843|NCT03373461|147189230|OTHER||Ratio to placebo (of ratio to baseline)|0.94|||||TWO_SIDED|80.0|0.76|0.98||||||||0.98|0.76|
73820844|NCT03373461|147189230|OTHER||Ratio to placebo (of ratio to baseline)|0.87|||||TWO_SIDED|80.0|0.72|0.96||||||||0.96|0.72|
73820845|NCT03373461|147189230|OTHER||Ratio to placebo (of ratio to baseline)|0.77|||||TWO_SIDED|80.0|0.66|0.92||||||||0.92|0.66|
73820846|NCT03373461|147189231|OTHER||Mean Difference (Final Values)|3.28|||||TWO_SIDED|80.0|0.21|6.344||||||||6.344|0.210|
73820847|NCT03373461|147189231|OTHER||Mean Difference (Final Values)|5.83|||||TWO_SIDED|80.0|2.642|9.01||||||||9.010|2.642|
73820848|NCT03373461|147189231|OTHER||Mean Difference (Final Values)|3.56|||||TWO_SIDED|80.0|0.427|6.7||||||||6.700|0.427|
73820849|NCT03373461|147189231|OTHER||Mean Difference (Final Values)|5.76|||||TWO_SIDED|80.0|2.882|8.638||||||||8.638|2.882|
73820850|NCT03373461|147189232|OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|80.0|-15.253|-3.145||||||||-3.145|-15.253|
73820851|NCT03373461|147189232|OTHER||Mean Difference (Final Values)|-9.25|||||TWO_SIDED|80.0|-15.499|-3.0||||||||-3.000|-15.499|
73820852|NCT03373461|147189232|OTHER||Mean Difference (Final Values)|-5.89|||||TWO_SIDED|80.0|-12.04|0.26||||||||0.260|-12.040|
73820853|NCT03373461|147189232|OTHER||Mean Difference (Final Values)|-10.12|||||TWO_SIDED|80.0|-15.763|-4.471||||||||-4.471|-15.763|
73820854|NCT03373461|147189234|OTHER||Ratio to placebo (of ratio to baseline)|0.95|||||TWO_SIDED|80.0|0.742|1.222||||||||1.222|0.742|
73820855|NCT03373461|147189234|OTHER||Ratio to placebo (of ratio to baseline)|1.06|||||TWO_SIDED|80.0|0.83|1.356||||||||1.356|0.830|
73820856|NCT03373461|147189234|OTHER||Ratio to placebo (of ratio to baseline)|0.73|||||TWO_SIDED|80.0|0.569|0.928||||||||0.928|0.569|
73820857|NCT03373461|147189234|OTHER||Ratio to placebo (of ratio to baseline)|0.84|||||TWO_SIDED|80.0|0.669|1.05||||||||1.050|0.669|
73820858|NCT03373461|147189235|OTHER||Ratio to placebo (of ratio to baseline)|0.96|||||TWO_SIDED|80.0|0.741|1.25||||||||1.250|0.741|
73820859|NCT03373461|147189235|OTHER||Ratio to placebo (of ratio to baseline)|1.13|||||TWO_SIDED|80.0|0.872|1.458||||||||1.458|0.872|
73820860|NCT03373461|147189235|OTHER||Ratio to placebo (of ratio to baseline)|0.74|||||TWO_SIDED|80.0|0.574|0.957||||||||0.957|0.574|
73820861|NCT03373461|147189235|OTHER||Ratio to placebo (of ratio to baseline)|0.89|||||TWO_SIDED|80.0|0.706|1.132||||||||1.132|0.706|
73820862|NCT03373461|147189236|OTHER||Ratio to placebo (of ratio to baseline)|0.98|||||TWO_SIDED|80.0|0.794|1.214||||||||1.214|0.794|
73820863|NCT03373461|147189236|OTHER||Ratio to placebo (of ratio to baseline)|1.03|||||TWO_SIDED|80.0|0.835|1.269||||||||1.269|0.835|
73820864|NCT03373461|147189236|OTHER||Ratio to placebo (of ratio to baseline)|0.76|||||TWO_SIDED|80.0|0.616|0.942||||||||0.942|0.616|
73820865|NCT03373461|147189236|OTHER||Ratio to placebo (of ratio to baseline)|0.85|||||TWO_SIDED|80.0|0.704|1.027||||||||1.027|0.704|
73820866|NCT03373461|147189237|OTHER||Ratio to placebo (of ratio to baseline)|0.92|||||TWO_SIDED|80.0|0.723|1.172||||||||1.172|0.723|
73820867|NCT03373461|147189237|OTHER||Ratio to placebo (of ratio to baseline)|0.98|||||TWO_SIDED|80.0|0.767|1.249||||||||1.249|0.767|
73820868|NCT03373461|147189237|OTHER||Ratio to placebo (of ratio to baseline)|0.74|||||TWO_SIDED|80.0|0.577|0.937||||||||0.937|0.577|
73820869|NCT03373461|147189237|OTHER||Ratio to placebo (of ratio to baseline)|0.84|||||TWO_SIDED|80.0|0.678|1.052||||||||1.052|0.678|
73820870|NCT03373461|147189246|OTHER||Mean Difference (Final Values)|3.95|||||TWO_SIDED|80.0|0.42|7.472||||||||7.472|0.420|
73820871|NCT03373461|147189246|OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|80.0|-2.747|4.39||||||||4.390|-2.747|
73820872|NCT03373461|147189246|OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|80.0|-2.745|3.262||||||||3.262|-2.745|
73820873|NCT03373461|147189246|OTHER||Mean Difference (Final Values)|1.98|||||TWO_SIDED|80.0|-1.368|5.337||||||||5.337|-1.368|
73820874|NCT03373461|147189247|OTHER||Ratio to placebo (of ratio to baseline)|1.04|||||TWO_SIDED|80.0|0.68|1.579||||||||1.579|0.680|
73820875|NCT03373461|147189247|OTHER||Ratio to placebo (of ratio to baseline)|0.92|||||TWO_SIDED|80.0|0.607|1.39||||||||1.390|0.607|
73820876|NCT03373461|147189247|OTHER||Ratio to placebo (of ratio to baseline)|0.8|||||TWO_SIDED|80.0|0.558|1.153||||||||1.153|0.558|
73820877|NCT03373461|147189247|OTHER||Ratio to placebo (of ratio to baseline)|0.91|||||TWO_SIDED|80.0|0.614|1.362||||||||1.362|0.614|
73820878|NCT03373461|147189249|OTHER||Geometric mean ratio|1.16|||||TWO_SIDED|80.0|0.792|1.692||||||||1.692|0.792|
73820879|NCT03373461|147189249|OTHER||Geometric mean ratio|0.65|||||TWO_SIDED|80.0|0.446|0.945||||||||0.945|0.446|
73820880|NCT03373461|147189249|OTHER||Geometric mean ratio|0.72|||||TWO_SIDED|80.0|0.518|0.997||||||||0.997|0.518|
73820881|NCT03373461|147189249|OTHER||Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.558|1.146||||||||1.146|0.558|
73820882|NCT03373461|147189250|OTHER||Ratio to placebo (of ratio to baseline)|1.14|||||TWO_SIDED|80.0|0.765|1.699||||||||1.699|0.765|
73820883|NCT03373461|147189250|OTHER||Ratio to placebo (of ratio to baseline)|0.66|||||TWO_SIDED|80.0|0.446|0.984||||||||0.984|0.446|
73820884|NCT03373461|147189250|OTHER||Ratio to placebo (of ratio to baseline)|0.71|||||TWO_SIDED|80.0|0.501|0.995||||||||0.995|0.501|
73820885|NCT03373461|147189250|OTHER||Ratio to placebo (of ratio to baseline)|0.76|||||TWO_SIDED|80.0|0.52|1.107||||||||1.107|0.520|
73820886|NCT00461097|147189256|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.5||||0.025|TWO_SIDED|95.0|4.3|43.9||No adjustments were made to the p-value.|Barnard's statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of egg white solid was compared using Barnard's statistic with the null hypothesis that there was no difference between treatment groups.||43.9|4.3|0.025
73820887|NCT03654729|147189264|SUPERIORITY||Risk Ratio (RR)|1.3842||||0.2266|TWO_SIDED|95.0|0.8172|2.3446|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel estimate of the common relative risk of moderate to severe CIPN.||2.3446|0.8172|0.2266
73820888|NCT03654729|147189264|SUPERIORITY||Risk Ratio (RR)|1.0951||||0.7434|TWO_SIDED|95.0|0.6356|1.887|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel estimate of the common relative risk of moderate to severe CIPN.||1.8870|0.6356|0.7434
73820889|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-4.4|1.3||||||Serotype 1: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||1.3|-4.4|
73820890|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-6.2|0.1||||||Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.1|-6.2|
73820891|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-5.6|0.5||||||Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.5|-5.6|
73820892|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-5.0|||||TWO_SIDED|95.0|-9.6|-0.9||||||Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-0.9|-9.6|
73820893|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-8.1|||||TWO_SIDED|95.0|-13.0|-4.0||||||Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-4.0|-13.0|
73820894|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-8.6|||||TWO_SIDED|95.0|-14.0|-3.7||||||Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-3.7|-14.0|
73820895|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-3.2|||||TWO_SIDED|95.0|-6.8|-0.3||||||Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-0.3|-6.8|
73820896|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-6.4|0.4||||||Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.4|-6.4|
73820897|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-4.4|2.4||||||Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.4|-4.4|
73820898|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-5.6|0.5||||||Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.5|-5.6|
73820899|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.1|-2.1|
73820900|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.7|1.7||||||Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.7|
73820901|NCT04530838|147189286|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-4.0|||||TWO_SIDED|95.0|-9.5|1.2||||||Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.2|-9.5|
73820902|NCT04530838|147189286|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|5.9|||||TWO_SIDED|95.0|3.0|10.0||||||Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.0|3.0|
73820903|NCT04530838|147189286|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|-33.5|||||TWO_SIDED|95.0|-40.7|-26.2||||||Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-26.2|-40.7|
73820904|NCT04530838|147189286|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|6.4|||||TWO_SIDED|95.0|3.8|10.4||||||Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.4|3.8|
73820905|NCT04530838|147189286|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|-19.0|||||TWO_SIDED|95.0|-25.7|-12.5||||||Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-12.5|-25.7|
73820906|NCT04530838|147189286|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|5.5|||||TWO_SIDED|95.0|2.2|9.6||||||Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||9.6|2.2|
73820907|NCT04530838|147189286|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|6.4|||||TWO_SIDED|95.0|3.8|10.4||||||Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.4|3.8|
73820908|NCT04530838|147189286|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|1.3|||||TWO_SIDED|95.0|-3.2|6.0||||||Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||6.0|-3.2|
73820909|NCT04530838|147189286|OTHER||Percentage Difference|-5.7|||||TWO_SIDED|95.0|-10.4|-1.7||||||Serotype 1: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-1.7|-10.4|
73820910|NCT04530838|147189286|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-5.2|2.9||||||Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.9|-5.2|
73820911|NCT04530838|147189286|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-6.2|1.9||||||Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.9|-6.2|
73820912|NCT04530838|147189286|OTHER||Percentage Difference|0.7|||||TWO_SIDED|95.0|-4.5|5.8||||||Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||5.8|-4.5|
73820913|NCT04530838|147189286|OTHER||Percentage Difference|4.8|||||TWO_SIDED|95.0|-0.2|10.0||||||Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.0|-0.2|
73820914|NCT04530838|147189286|OTHER||Percentage Difference|-5.6|||||TWO_SIDED|95.0|-12.5|1.1||||||Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.1|-12.5|
73820915|NCT04530838|147189286|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-5.4|3.1||||||Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||3.1|-5.4|
73820916|NCT04530838|147189286|OTHER||Percentage Difference|-3.0|||||TWO_SIDED|95.0|-7.7|1.4||||||Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.4|-7.7|
73820917|NCT04530838|147189286|OTHER||Percentage Difference|-0.6|||||TWO_SIDED|95.0|-4.4|3.2||||||Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||3.2|-4.4|
73820918|NCT04530838|147189286|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-6.2|1.9||||||Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.9|-6.2|
73820919|NCT04530838|147189286|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-3.0|1.7||||||Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-3.0|
73820920|NCT04530838|147189286|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
73820921|NCT04530838|147189286|OTHER||Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.9|5.1||||||Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||5.1|-6.9|
73820922|NCT04530838|147189286|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.2|2.1||||||Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.1|-2.2|
73820923|NCT04530838|147189286|OTHER||Percentage Difference|-0.6|||||TWO_SIDED|95.0|-9.8|8.6||||||Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||8.6|-9.8|
73820924|NCT04530838|147189286|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
73820925|NCT04530838|147189286|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-8.2|8.2||||||Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||8.2|-8.2|
73820926|NCT04530838|147189286|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-3.3|2.0||||||Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.0|-3.3|
73820927|NCT04530838|147189286|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
73820928|NCT04530838|147189286|OTHER||Percentage Difference|-2.5|||||TWO_SIDED|95.0|-7.5|2.2||||||Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.2|-7.5|
73820929|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.62|||||TWO_SIDED|95.0|0.54|0.72||||||Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.72|0.54|
73820930|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.71|||||TWO_SIDED|95.0|0.63|0.81||||||Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.81|0.63|
73820931|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.6|||||TWO_SIDED|95.0|0.51|0.7||||||Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.70|0.51|
73820932|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.59|||||TWO_SIDED|95.0|0.49|0.71||||||Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.71|0.49|
73820933|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.59|||||TWO_SIDED|95.0|0.5|0.7||||||Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.70|0.50|
73820934|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.51|||||TWO_SIDED|95.0|0.4|0.64||||||Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.64|0.40|
73820935|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.72|||||TWO_SIDED|95.0|0.62|0.84||||||Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.84|0.62|
73820936|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.69|||||TWO_SIDED|95.0|0.6|0.8||||||Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.80|0.60|
73820937|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.01|0.70|
73820938|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.66|||||TWO_SIDED|95.0|0.57|0.77||||||Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.77|0.57|
73820939|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.76|||||TWO_SIDED|95.0|0.65|0.87||||||Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.87|0.65|
73820940|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.75|||||TWO_SIDED|95.0|0.67|0.85||||||Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.85|0.67|
73820941|NCT04530838|147189287|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.64|||||TWO_SIDED|95.0|0.53|0.78||||||Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.78|0.53|
73820942|NCT04530838|147189287|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|4.01|||||TWO_SIDED|95.0|3.36|4.79||||||Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||4.79|3.36|
73820943|NCT04530838|147189287|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.6|||||TWO_SIDED|95.0|0.48|0.76||||||Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.76|0.48|
73820944|NCT04530838|147189287|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|6.8|||||TWO_SIDED|95.0|5.69|8.13||||||Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||8.13|5.69|
73820945|NCT04530838|147189287|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.95|||||TWO_SIDED|95.0|0.76|1.2||||||Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.20|0.76|
73820946|NCT04530838|147189287|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|8.18|||||TWO_SIDED|95.0|6.75|9.92||||||Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||9.92|6.75|
73820947|NCT04530838|147189287|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|5.97|||||TWO_SIDED|95.0|5.0|7.12||||||Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||7.12|5.00|
73820948|NCT04530838|147189287|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|2.06|||||TWO_SIDED|95.0|1.69|2.51||||||Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||2.51|1.69|
73820949|NCT04530838|147189287|OTHER||GMR|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.99|0.73|
73820950|NCT04530838|147189287|OTHER||GMR|0.85|||||TWO_SIDED|95.0|0.74|0.98||||||Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.98|0.74|
73820951|NCT04530838|147189287|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.16|0.83|
73820952|NCT04530838|147189287|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.19|0.81|
73820953|NCT04530838|147189287|OTHER||GMR|1.19|||||TWO_SIDED|95.0|0.98|1.44||||||Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.44|0.98|
73820954|NCT04530838|147189287|OTHER||GMR|0.93|||||TWO_SIDED|95.0|0.72|1.21||||||Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.21|0.72|
73820955|NCT04530838|147189287|OTHER||GMR|0.96|||||TWO_SIDED|95.0|0.82|1.12||||||Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.12|0.82|
73820956|NCT04530838|147189287|OTHER||GMR|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.16|0.85|
73820957|NCT04530838|147189287|OTHER||GMR|0.87|||||TWO_SIDED|95.0|0.72|1.04||||||Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.04|0.72|
73820958|NCT04530838|147189287|OTHER||GMR|0.92|||||TWO_SIDED|95.0|0.79|1.07||||||Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.07|0.79|
73820959|NCT04530838|147189287|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.84|1.13||||||Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.13|0.84|
73820960|NCT04530838|147189287|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.87|1.1||||||Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.10|0.87|
73820961|NCT04530838|147189287|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.19|0.81|
73820962|NCT04530838|147189287|OTHER||GMR|0.99|||||TWO_SIDED|95.0|0.87|1.13||||||Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.13|0.87|
73820963|NCT04530838|147189287|OTHER||GMR|0.94|||||TWO_SIDED|95.0|0.73|1.2||||||Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.20|0.73|
73820964|NCT04530838|147189287|OTHER||GMR|0.93|||||TWO_SIDED|95.0|0.81|1.06||||||Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.06|0.81|
73820965|NCT04530838|147189287|OTHER||GMR|0.91|||||TWO_SIDED|95.0|0.71|1.15||||||Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.15|0.71|
73820966|NCT04530838|147189287|OTHER||GMR|1.0|||||TWO_SIDED|95.0|0.85|1.18||||||Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.18|0.85|
73820967|NCT04530838|147189287|OTHER||GMR|0.89|||||TWO_SIDED|95.0|0.78|1.02||||||Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.02|0.78|
73820968|NCT04530838|147189287|OTHER||GMR|0.95|||||TWO_SIDED|95.0|0.79|1.15||||||Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.15|0.79|
73820969|NCT00803712|147189294|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Hypothesis to be tested: the proportion of participants achieving the specified PTH target of ≥ 30% reduction in PTH from baseline will be greater in the cinacalcet plus low dose active vitamin D group than in the control group during the efficacy assessment phase at month 6 (weeks 22 to 26).||||<0.0001
73820970|NCT00803712|147189295|SUPERIORITY_OR_OTHER|||||||0.0002||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel|||||||0.0002
73820971|NCT00803712|147189296|SUPERIORITY_OR_OTHER|||||||0.0139||||||Adjusted p-value is presented. P-value is adjusted using Dubey and Armitage-Parmer method of adjusting for multiple comparisons|Cochran-Mantel-Haenszel|||||||0.0139
73820972|NCT00803712|147189297|SUPERIORITY_OR_OTHER|||||||0.2386||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel|||||||0.2386
73820973|NCT00803712|147189298|SUPERIORITY_OR_OTHER|||||||0.0875|||||||Cochran-Mantel-Haenszel|||||||0.0875
73820974|NCT00803712|147189299|SUPERIORITY_OR_OTHER|||||||0.4304|||||||Cochran-Mantel-Haenszel|||||||0.4304
73820975|NCT00803712|147189300|SUPERIORITY_OR_OTHER|||||||0.091|||||||Cochran-Mantel-Haenszel|||||||0.0910
73820976|NCT00803712|147189301|SUPERIORITY_OR_OTHER|||||||0.952|||||||Cochran-Mantel-Haenszel|||||||0.9520
73820977|NCT00803712|147189302|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
73820978|NCT00803712|147189303|SUPERIORITY_OR_OTHER|||||||0.0611|||||||Cochran-Mantel-Haenszel|||||||0.0611
73820979|NCT00803712|147189304|SUPERIORITY_OR_OTHER|||||||0.3298|||||||Cochran-Mantel-Haenszel|||||||0.3298
73820980|NCT00803712|147189305|SUPERIORITY_OR_OTHER|||||||0.4436|||||||Cochran-Mantel-Haenszel|||||||0.4436
73820981|NCT00803712|147189306|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data||||||<0.0001
73820982|NCT00803712|147189307|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.||||||<0.0001
73820983|NCT00803712|147189308|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data||||||0.0040
73820984|NCT00803712|147189309|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.||||||<0.0001
73820985|NCT00803712|147189310|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium||||||<0.0001
73820986|NCT00803712|147189311|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
73820987|NCT00803712|147189312|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
73820988|NCT00803712|147189313|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
73820989|NCT00803712|147189314|SUPERIORITY_OR_OTHER|||||||0.0085|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.0085
73820990|NCT00803712|147189315|SUPERIORITY_OR_OTHER|||||||0.071|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.0710
73820991|NCT00803712|147189316|SUPERIORITY_OR_OTHER|||||||0.3546|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.3546
73820992|NCT00803712|147189317|SUPERIORITY_OR_OTHER|||||||0.7518|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.7518
73820993|NCT02672176|147189325|EQUIVALENCE|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73820994|NCT02672176|147189326|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73820995|NCT02672176|147189327|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73820996|NCT02672176|147189328|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73820997|NCT02672176|147189329|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73820998|NCT02672176|147189330|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73820999|NCT02672176|147189331|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73821000|NCT02672176|147189332|EQUIVALENCE|Information in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73821001|NCT02672176|147189333|EQUIVALENCE|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73821002|NCT01919164|147189346|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Descriptive statistics was provided for primary endpoint.||0.03|-0.01|
73821003|NCT01919164|147189346|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.01|0.04||||||Descriptive statistics was provided for primary endpoint.||0.04|-0.01|
73821004|NCT01919164|147189346|SUPERIORITY||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|0.02|0.06||||||Descriptive statistics was provided for primary endpoint.||0.06|0.02|
73821005|NCT01919164|147189346|SUPERIORITY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|0.03|0.07||||||Descriptive statistics was provided for primary endpoint.||0.07|0.03|
73821006|NCT03442725|147189365|OTHER||Geometric Mean Ratio|1.297|||||TWO_SIDED|90.0|0.6|2.805||||||Analysis of variance (ANOVA) comparison of Cmax for telotristat ethyl between test group versus the control group.||2.805|0.600|
73821007|NCT03442725|147189365|OTHER||Geometric Mean Ratio|1.423|||||TWO_SIDED|90.0|0.901|2.247||||||ANOVA comparison of Cmax for LP-778902 between test group versus the control group.||2.247|0.901|
73821008|NCT03442725|147189366|OTHER|Estimate of the median difference and 90% confidence intervals (CIs) was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7452|TWO_SIDED|90.0|-1.0|0.95|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for telotristat ethyl between test group versus the control group.||0.950|-1.000|0.7452
73821009|NCT03442725|147189366|OTHER|Estimate of the median difference and 90% CIs was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7039|TWO_SIDED|90.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for LP-778902 between test group versus the control group.||1.000|-1.000|0.7039
73821010|NCT03442725|147189368|OTHER||Geometric Mean Ratio|1.506|||||TWO_SIDED|90.0|0.914|2.48||||||ANOVA comparison of AUC0-inf for LP-778902 between test group versus the control group.||2.480|0.914|
73821011|NCT03442725|147189369|OTHER||Geometric Mean Ratio|1.512|||||TWO_SIDED|90.0|0.915|2.498||||||ANOVA comparison of AUC0-tlast for LP-778902 between test group versus the control group.||2.498|0.915|
73821012|NCT03442725|147189373|OTHER||Arithmetic Mean Difference|0.019|||||TWO_SIDED|90.0|-0.03|0.068||||||ANOVA comparison of fu of LP-778902 between test group versus the control group.||0.068|-0.030|
73821013|NCT03442725|147189374|OTHER||Geometric Mean Ratio|1.727|||||TWO_SIDED|90.0|0.866|3.443||||||ANOVA comparison of Cmaxu for LP-778902 between test group versus the control group.||3.443|0.866|
73821014|NCT03442725|147189375|OTHER||Geometric Mean Ratio|1.828|||||TWO_SIDED|90.0|0.903|3.699||||||ANOVA comparison of AUC0-infu for LP-778902 between test group versus the control group.||3.699|0.903|
73821015|NCT03442725|147189376|OTHER||Geometric Mean Ratio|1.835|||||TWO_SIDED|90.0|0.904|3.726||||||ANOVA comparison of AUC0-tlastu for LP-778902 between test group versus the control group.||3.726|0.904|
73821016|NCT02501161|147189417|OTHER||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.||||<.0001
73821017|NCT02501161|147189418|OTHER||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.||||<.0001
73821018|NCT03159299|147189471|SUPERIORITY||Mean Difference (Final Values)|0.11|||<|0.15|TWO_SIDED||||||Mixed Models Analysis|||||||<0.15
73821019|NCT01431313|147189507|OTHER|Mixed effects model across all time points.||||||0.002|||||||Mixed Models Analysis|||||||0.002
73821020|NCT01431313|147189507|OTHER|Mixed effects model across all time points.||||||0.003|||||||Mixed Models Analysis|||||||0.003
73821021|NCT01431313|147189507|OTHER|Mixed effects model across all time points.||||||0.66|||||||Mixed Models Analysis|||||||0.66
73821022|NCT01431313|147189509|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73821023|NCT01431313|147189509|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73821024|NCT01431313|147189509|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73821025|NCT01431313|147189510|OTHER|Mixed effects model across all time points.||||||0.8|||||||Mixed Models Analysis|||||||0.8
73821026|NCT01431313|147189510|OTHER|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis|||||||0.01
73821027|NCT01431313|147189510|OTHER|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis|||||||0.01
73821028|NCT01431313|147189511|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
73821029|NCT01431313|147189511|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
73821030|NCT01431313|147189511|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
73821031|NCT01431313|147189512|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73821032|NCT01431313|147189512|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73821033|NCT01431313|147189512|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73821034|NCT01431313|147189513|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73821035|NCT01431313|147189513|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73821036|NCT01431313|147189514|OTHER|Mixed effects model across all doses.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73821037|NCT01431313|147189514|OTHER|Mixed effects model across all doses.||||||0.21|||||||Mixed Models Analysis|||||||0.21
73821038|NCT01431313|147189514|OTHER|Mixed effects model across all doses.||||||0.59|||||||Mixed Models Analysis|||||||0.59
73821039|NCT01990573|147189518|OTHER|ANOVA|F statistic|0.002||||0.002|TWO_SIDED||||||ANOVA|||||||.002
73821040|NCT01990573|147189519|OTHER|ANOVA|F statistic|0.962||||0.962|TWO_SIDED||||||ANOVA|||||||.962
73821041|NCT00524771|147189541|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test of two exponential survival curves . These calculations are based on the following assumptions: 1) one-sided α of 0.025; 2) power (1-β) of 0.80; VTE incidence rate of 9.1 VTE/10.000 WY and 4) non-inferiority limit on hazard ratio of 2.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.5|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COCs is higher or equal to 2. This analysis represents the a priori defined primary statistical analysis.||1.5|0.5|
73821042|NCT00524771|147189541|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COC2 is higher or equal to 2.||1.7|0.4|
73821043|NCT00524771|147189541|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.2|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of less than 6 months.||2.2|0.3|
73821044|NCT00524771|147189541|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.6|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of 6 - 12 months.||2.6|0.3|
73821045|NCT00524771|147189541|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.3|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of \> 12 months.||2.3|0.3|
73821046|NCT00524771|147189542|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.3|||||The hazard ratio was adjusted for age, BMI, Smoking, and treated hypertension.|||2.3|0.2|
73821047|NCT00524771|147189542|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.2|2.6|||||Hazard ratio was adjusted for age, BMI, smoking, and treated hypertension.|||2.6|0.2|
73821048|NCT01000974|147189565|NON_INFERIORITY|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBV-IPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentration ≥ 1.0 μg/mL.|difference in percentage|-8.59|||||TWO_SIDED|95.0|-12.28|-4.07|||Non-inferiority analysis|||Non-inferiority Anti-PRP concentration ≥ 1.0 μg/mL||-4.07|-12.28|
73821049|NCT01000974|147189565|NON_INFERIORITY|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBVIPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentrations ≥ 0.15 μg/mL.|Difference in percentage|-0.11|||||TWO_SIDED|95.0|-1.98|2.82|||Non-inferiority analysis|||Non-inferiority Anti-PRP concentration≥ 0.15 μg/mL||2.82|-1.98|
73821050|NCT01000974|147189566|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to diphtheria (Anti-D).|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.26|1.81|||Non-inferiority analysis|||Non-inferiority Anti-D antibody concentrations||1.81|-1.26|
73821051|NCT01000974|147189566|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to tetanus (Anti-T).|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.26|1.8|||Non-inferiority analysis|||Non-inferiority Anti-T antibody concentrations||1.8|-1.26|
73821052|NCT01000974|147189568|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertussis toxoid \[PT\].|GMC ratio|1.017|||||TWO_SIDED|97.5|0.918|1.127|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-PT||1.127|0.918|
73821053|NCT01000974|147189568|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to filamentous hemagglutinin \[FHA\].|GMC ratio|1.088|||||TWO_SIDED|97.5|0.983|1.204|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-FHA||1.204|0.983|
73821054|NCT01000974|147189568|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertactin \[PRN\]|GMC ratio|1.193|||||TWO_SIDED|97.5|1.03|1.382|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-PRN||1.382|1.03|
73821055|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.006|||||TWO_SIDED|97.5|0.873|1.159|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 1 concentrations||1.159|0.873|
73821056|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.048|||||TWO_SIDED|97.5|0.921|1.192|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 3 concentrations||1.192|0.921|
73821057|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||TWO_SIDED|97.5|0.886|1.13|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 4 concentrations||1.13|0.886|
73821058|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.02|||||TWO_SIDED|97.5|0.874|1.19|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 5 concentrations||1.19|0.874|
73821059|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.031|||||TWO_SIDED|97.5|0.894|1.188|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 6A concentrations||1.188|0.894|
73821060|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.072|||||TWO_SIDED|97.5|0.871|1.32|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 6B concentrations||1.32|0.871|
73821061|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.098|||||TWO_SIDED|97.5|0.964|1.251|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 7F concentrations||1.251|0.964|
73821062|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.035|||||TWO_SIDED|97.5|0.89|1.204|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 9V concentrations||1.204|0.89|
73821063|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.096|||||TWO_SIDED|97.5|0.929|1.294|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 14 concentrations||1.294|0.929|
73821064|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.042|||||TWO_SIDED|97.5|0.9|1.207|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 18C concentrations||1.207|0.9|
73821065|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||TWO_SIDED|97.5|0.859|1.167|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 19A concentrations||1.167|0.859|
73821066|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|0.969|||||TWO_SIDED|97.5|0.855|1.098|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 19F concentrations||1.098|0.855|
73821067|NCT01000974|147189569|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.031|||||TWO_SIDED|97.5|0.862|1.232|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 23F concentrations||1.232|0.862|
73821068|NCT01000974|147189570|OTHER|To rule out 10% decrease in seroresponse to FHA in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001|||||||t-test, 1 sided|P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 \& the posterior probability of the cut-off in the control group||Difference in seroresponse Anti-FHA||||<0.0001
73821069|NCT01000974|147189570|OTHER|To rule out 10% decrease in seroresponse to PT in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PT||||<0.0001
73821070|NCT01000974|147189570|OTHER|To rule out 10% decrease in seroresponse to PRN in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PRN||||<0.0001
73821071|NCT01000974|147189571|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 1.|Difference in percentage|-0.67|||||TWO_SIDED|97.5|-2.24|0.87|||Non-inferiority analysis|||Non-inferiority Anti-Polio 1 concentrations||0.87|-2.24|
73821072|NCT01000974|147189571|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 2.|Difference in percentage|0.45|||||TWO_SIDED|97.5|-1.45|2.91|||Non-inferiority analysis|||Non-inferiority Anti-Polio 2 concentration||2.91|-1.45|
73821073|NCT01000974|147189571|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 3.|Difference in percentage|-0.66|||||TWO_SIDED|97.5|-2.2|0.88|||Non-inferiority analysis|||Non-inferiority Anti-Polio 3 concentration||0.88|-2.2|
73821074|NCT02485483|147189615|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.67|||<|0.001|TWO_SIDED|95.0|0.59|0.74||"Convergent Validity Criterion Correlation coefficient (ρ) \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 221||0.74|0.59|<0.001
73821075|NCT02485483|147189615|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.69|||<|0.001|TWO_SIDED|95.0|0.62|0.76||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 222||0.76|0.62|<0.001
73821076|NCT02485483|147189616|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.58||||0.057|TWO_SIDED|95.0|0.48|0.66||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 203||0.66|0.48|0.057
73821077|NCT02485483|147189616|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.8||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 200||0.80|0.67|<0.001
73821078|NCT02485483|147189617|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.79||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 258||0.79|0.67|<0.001
73821079|NCT02485483|147189618|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.77||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 214||0.77|0.64|<0.001
73821080|NCT02485483|147189619|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.59||||0.034|TWO_SIDED|95.0|-0.67|-0.49||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 222||-0.49|-0.67|0.034
73821081|NCT02485483|147189619|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.61||||0.01|TWO_SIDED|95.0|-0.68|-0.52||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 223||-0.52|-0.68|0.010
73821082|NCT02485483|147189619|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.73|||<|0.001|TWO_SIDED|95.0|-0.78|-0.66||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 222||-0.66|-0.78|<0.001
73821083|NCT02485483|147189620|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.54||||0.219|TWO_SIDED|95.0|-0.63|-0.43||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 202||-0.43|-0.63|0.219
73821084|NCT02485483|147189620|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.68|||<|0.001|TWO_SIDED|95.0|-0.75|-0.6||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 199||-0.60|-0.75|<0.001
73821085|NCT02485483|147189620|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.77|||<|0.001|TWO_SIDED|95.0|-0.82|-0.7||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 205||-0.70|-0.82|<0.001
73821086|NCT01724177|147189629|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"A one sample binomial one sided exact test for the ORR (CR, CRu, or PR) was performed to provide the p-value (significance level: 0.05). The hypotheses of interest:~H0: ORR ≤ 5% versus H1: ORR \> 5%"|Exact Test|||||||<0.0001
73821087|NCT00158262|147189665|SUPERIORITY||Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-2.7|16.7|||||Placebo-Propranolol|||16.7|-2.7|
73821088|NCT00158262|147189666|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-15.5|15.3|||||Placebo-Propranolol|CAPS Total Score at Month 1||15.3|-15.5|
73821089|NCT00158262|147189666|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-20.3|16.0||||||CAPS Total Score at Month 3||16.0|-20.3|
73821090|NCT00158262|147189667|SUPERIORITY||Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|-4.8|10.7|||||Placebo-Propranolol|||10.7|-4.8|
73821091|NCT02585713|147189679|SUPERIORITY|||||||0.1316|||||||Log Rank|||||||0.1316
73821092|NCT03173456|147189682|SUPERIORITY|||||||0.69||||||A priori threshold for statistical significance was 0.05. The plan was to only do individual comparisons between means if the overall test of the analysis of variance (AVOVA) was statistically significant|ANOVA|||The null hypothesis is that all means are equal. The alternate hypothesis is that one or more mean is less than or more than another.||||0.69
73821093|NCT03173456|147189683|SUPERIORITY|||||||0.85||||||Threshold for statistical significance was 0.05. The plan was to only compare means if the overall test of AVOVA was statistically significant.|ANOVA|||||||0.85
73821094|NCT03173456|147189684|SUPERIORITY|||||||0.99||||||Threshold for statistical significance = 0.05|Chi-squared|||||||0.99
73821095|NCT03173456|147189686|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
73821096|NCT03173456|147189687|SUPERIORITY|||||||0.0501||||||0.05 was the a priori threshold for statistical significance|Chi-squared|||||||0.0501
73821097|NCT01733121|147189688|OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-4.5|-1.6|||ANCOVA|||||-1.6|-4.5|<.0001
73821098|NCT01733121|147189689|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANOVA|||||-0.4|-1.2|<0.0001
73821099|NCT01733121|147189690|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.7||0.0005|TWO_SIDED|95.0|-3.7|-1.1|||ANCOVA|||||-1.1|-3.7|0.0005
73821100|NCT01733121|147189691|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||ANOVA|||||-0.5|-1.2|<.0001
73821101|NCT04501952|147189701|SUPERIORITY||Hazard Ratio (HR)|0.134||||0.0076|TWO_SIDED|95.0|0.031|0.586|||Regression, Cox|P-value was estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% confidence interval (CI) were estimated using the Cox regression with baseline stratification factors as covariates.|||0.586|0.031|0.0076
73821102|NCT04501952|147189703|SUPERIORITY||Hazard Ratio (HR)|0.191||||0.0024|TWO_SIDED|95.0|0.065|0.555|||Regression, Cox|P-value was estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.555|0.065|0.0024
73821103|NCT04501952|147189706|SUPERIORITY||Hazard Ratio (HR)|0.134||||0.0076|TWO_SIDED|95.0|0.031|0.586|||Regression, Cox|P-value were estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.586|0.031|0.0076
73821104|NCT04501952|147189707|SUPERIORITY||Hazard Ratio (HR)|0.1||||0.0019|TWO_SIDED|95.0|0.023|0.43|||Regression, Cox|P-value were estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.430|0.023|0.0019
73821105|NCT04501952|147189708|SUPERIORITY||Least Squares Mean|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4318|TWO_SIDED|95.0|-0.1|0.24|||ANCOVA|P-value were from an ANCOVA model with baseline viral load as a covariate.|Least squares Mean (LSM), standard error (SE) and 95% CI were from an ANCOVA model with baseline viral load as a covariate.|||0.24|-0.10|0.4318
73821106|NCT04501952|147189709|SUPERIORITY||Hazard Ratio (HR)|1.405||||0.2987|TWO_SIDED|95.0|0.733|2.693|||Log Rank|p-value was based on stratified log-rank test with baseline stratification factor as strata.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||2.693|0.733|0.2987
73821107|NCT04501952|147189711|SUPERIORITY|||||||0.2163|||||||Fisher Exact|||||||0.2163
73821108|NCT00941304|147189712|SUPERIORITY_OR_OTHER||LS Mean Difference|3.34||||0.4739|TWO_SIDED|95.0|-5.94|12.62|||ANCOVA|||||12.62|-5.94|.4739
73821109|NCT00941304|147189712|SUPERIORITY_OR_OTHER||LS Mean Difference|6.26||||0.2183|TWO_SIDED|95.0|-3.81|16.34|||ANCOVA|||||16.34|-3.81|.2183
73821110|NCT00941304|147189712|SUPERIORITY_OR_OTHER||LS Mean Difference|8.74||||0.0809|TWO_SIDED|95.0|-1.11|18.56|||ANCOVA|||||18.56|-1.11|.0809
73821111|NCT00784719|147189727|SUPERIORITY_OR_OTHER||Median|59.0|||||TWO_SIDED|80.0|57.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||57.0|
73821112|NCT00784719|147189727|SUPERIORITY_OR_OTHER||Median|58.0|||||TWO_SIDED|80.0|58.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||58.0|
73821113|NCT00784719|147189727|SUPERIORITY_OR_OTHER||Median|57.0|||||TWO_SIDED|80.0|29.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||29.0|
73821114|NCT00784719|147189729|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|9.0|28.0||||||||28.0|9.0|
73821115|NCT00784719|147189729|SUPERIORITY_OR_OTHER||Median|8.5|||||TWO_SIDED|80.0|8.0|27.0||||||||27.0|8.0|
73821116|NCT00784719|147189729|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|15.0|27.0||||||||27.0|15.0|
73821117|NCT00784719|147189729|SUPERIORITY_OR_OTHER||Median|9.5|||||TWO_SIDED|80.0|8.0|15.0||||||||15.0|8.0|
73821118|NCT00784719|147189729|SUPERIORITY_OR_OTHER||Median|9.0|||||TWO_SIDED|80.0|8.0|15.0||||||||15.0|8.0|
73821119|NCT00784719|147189729|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|8.0|43.0||||||||43.0|8.0|
73821120|NCT00784719|147189729|SUPERIORITY_OR_OTHER||Median|16.0|||||TWO_SIDED|80.0|15.0|30.0||||||||30.0|15.0|
73821121|NCT01408901|147189746|SUPERIORITY||Mean Difference (Final Values)|28.7||||0.052|TWO_SIDED|95.0|5.1|52.3||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||52.3|5.1|0.052
73821122|NCT01408901|147189746|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.91|TWO_SIDED|95.0|-30.2|17.6||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||17.6|-30.2|0.91
73821123|NCT01408901|147189746|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.91|TWO_SIDED|95.0|-25.2|22.4||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||22.4|-25.2|0.91
73821124|NCT01408901|147189746|SUPERIORITY||Mean Difference (Final Values)|33.6||||0.02|TWO_SIDED|95.0|9.4|57.7||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||57.7|9.4|0.02
73821125|NCT01408901|147189747|SUPERIORITY||Hodges-Lehmann estimator|-0.61||||0.49|TWO_SIDED|95.0|-1.67|0.44||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||0.44|-1.67|0.49
73821126|NCT01408901|147189747|SUPERIORITY||Hodges-Lehmann estimator|-0.67||||0.49|TWO_SIDED|95.0|-1.84|0.51||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||0.51|-1.84|0.49
73821127|NCT01408901|147189747|SUPERIORITY||Hodges-Lehmann estimator|0.36||||0.49|TWO_SIDED|95.0|-0.66|1.38||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||1.38|-0.66|0.49
73821128|NCT01408901|147189747|SUPERIORITY||Hodges-Lehmann estimator|0.48||||0.49|TWO_SIDED|95.0|-0.64|1.59||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||1.59|-0.64|0.49
73821129|NCT01408901|147189748|SUPERIORITY||Mean Difference (Final Values)|3.6|||<|0.01|TWO_SIDED|95.0|2.1|5.0||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||5.0|2.1|<0.01
73821130|NCT01408901|147189748|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.44|TWO_SIDED|95.0|-2.1|0.8||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||0.8|-2.1|0.44
73821131|NCT01408901|147189748|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.44|TWO_SIDED|95.0|-2.1|0.9||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||0.9|-2.1|0.44
73821132|NCT01408901|147189748|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.01|TWO_SIDED|95.0|2.2|5.2||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||5.2|2.2|<0.01
73821133|NCT01408901|147189749|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.09|TWO_SIDED|95.0|-0.012|0.001|||t-test, 2 sided|||||0.001|-0.012|0.09
73821134|NCT01408901|147189750|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.03|TWO_SIDED|95.0|-0.01|-0.001|||t-test, 2 sided|||||-0.001|-0.010|0.03
73821135|NCT01408901|147189751|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.09|TWO_SIDED|95.0|-0.012|0.001|||t-test, 2 sided|||||0.001|-0.012|0.09
73821136|NCT01408901|147189752|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.17|TWO_SIDED|95.0|-0.009|0.002|||t-test, 2 sided|||||0.002|-0.009|0.17
73821137|NCT05464420|147189785|OTHER|Estimated difference in percentage and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|6.0|||||TWO_SIDED|95.0|3.0|8.6||||||Injection site erythema: V116 Combined Lots - PPSV23||8.6|3.0|
73821138|NCT05464420|147189785|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|12.6|||||TWO_SIDED|95.0|8.0|17.3||||||Injection site pain: V116 Combined Lots - PPSV23||17.3|8.0|
73821139|NCT05464420|147189785|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|5.6|||||TWO_SIDED|95.0|2.6|8.2||||||Injection site swelling: V116 Combined Lots - PPSV23||8.2|2.6|
73821140|NCT05464420|147189787|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|1.4|||||TWO_SIDED|95.0|-3.2|6.0||||||Fatigue: V116 Combined Lots - PPSV23||6.0|-3.2|
73821141|NCT05464420|147189787|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|5.8|||||TWO_SIDED|95.0|1.6|9.7||||||Headache: V116 Combined Lots - PPSV23||9.7|1.6|
73821142|NCT05464420|147189787|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|7.6|||||TWO_SIDED|95.0|4.5|10.5||||||Myalgia: V116 Combined Lots - PPSV23||10.5|4.5|
73821143|NCT05464420|147189787|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|0.8|||||TWO_SIDED|95.0|-1.0|2.1||||||Pyrexia: V116 Combined Lots - PPSV23||2.1|-1.0|
73821144|NCT05464420|147189789|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.2||||||Vaccine-related SAEs: V116 Combined Lots - PPSV23||0.2|-0.7|
73821145|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 2||1.24|0.96|<0.001
73821146|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/ V116 Lot 3|Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 3||1.17|0.90|<0.001
73821147|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.83|1.06||Identical p-values for the lower and upper bounds.|cLDA Model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/ V116 Lot 3|Serotype 3: GMT Ratio V116 Lot 2/ V116 Lot 3||1.06|0.83|<0.001
73821148|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.97|1.35||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.35|0.97|<0.001
73821149|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.88|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 3||1.22|0.88|<0.001
73821150|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.91|||<|0.001|TWO_SIDED|95.0|0.77|1.06||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 6A: GMT Ratio V116 Lot 2/ V116 Lot 3||1.06|0.77|<0.001
73821151|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.16|||<|0.001|TWO_SIDED|95.0|1.01|1.34||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 7F: V116 Lot 1/ V116 Lot 2||1.34|1.01|<0.001
73821152|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.94|1.25||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 7F: GMT Ratio V116 Lot 1/ V116 Lot 3||1.25|0.94|<0.001
73821153|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.81|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 7F: GMT Ratio V116 Lot 2/ V116 Lot 3||1.07|0.81|<0.001
73821154|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.92|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 8 V116 Lot 1/V116 Lot 2||1.16|0.92|<0.001
73821155|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.93|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/ V116 Lot 3|Serotype 8: GMT Ratio V116 Lot 1/ V116 Lot 3||1.18|0.93|<0.001
73821156|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.9|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/ V116 Lot 3|Serotype 8: GMT Ratio V116 Lot 2/ V116 Lot 3||1.14|0.90|<0.001
73821157|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 2||1.26|0.94|<0.001
73821158|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.87|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 3||1.17|0.87|<0.001
73821159|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.8|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 9N: GMT Ratio V116 Lot 2/V116 Lot 3||1.07|0.80|<0.001
73821160|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.11|0.85|<0.001
73821161|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 3||1.18|0.91|<0.001
73821162|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.93|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 10A: GMT Ratio V116 Lot 2/V116 Lot 3||1.21|0.93|<0.001
73821163|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 11A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.11|0.84|<0.001
73821164|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.87|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 11A: GMT Ratio V116 Lot 1/V116 Lot 3||1.16|0.87|<0.001
73821165|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.9|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 11A: GMT Ratio V116 Lot 2/V116 Lot 3||1.20|0.90|<0.001
73821166|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.96|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 2||1.26|0.96|<0.001
73821167|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.89|<0.001
73821168|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.81|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 12F: GMT Ratio V116 Lot 2/V116 Lot 3||1.07|0.81|<0.001
73821169|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.89|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 2||1.22|0.89|<0.001
73821170|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.86|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.86|<0.001
73821171|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 15A: GMT Ratio V116 Lot 2/V116 Lot 3||1.12|0.82|<0.001
73821172|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.95|1.38||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 2||1.38|0.95|<0.001
73821173|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.97|1.42||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 3||1.42|0.97|<0.001
73821174|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.85|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 15C: GMT Ratio V116 Lot 2/V116 Lot 3||1.23|0.85|<0.001
73821175|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 2||1.11|0.84|<0.001
73821176|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 3||1.11|0.84|<0.001
73821177|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.87|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 16F: GMT Ratio V116 Lot 2/V116 Lot 3||1.15|0.87|<0.001
73821178|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 2||1.11|0.85|<0.001
73821179|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.89|<0.001
73821180|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.92|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 17F: GMT Ratio V116 Lot 2/V116 Lot 3||1.20|0.92|<0.001
73821181|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.91|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 2||1.15|0.91|<0.001
73821182|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 3||1.07|0.84|<0.001
73821183|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.82|1.04||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 19A: GMT Ratio V116 Lot 2/V116 Lot 3||1.04|0.82|<0.001
73821184|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.84|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 2||1.14|0.84|<0.001
73821185|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.07|||<|0.001|TWO_SIDED|95.0|0.92|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 3||1.24|0.92|<0.001
73821186|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.27||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 20A: GMT Ratio V116 Lot 2/V116 Lot 3||1.27|0.94|<0.001
73821187|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.93|1.29||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 2||1.29|0.93|<0.001
73821188|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.87|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 3||1.21|0.87|<0.001
73821189|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.8|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 22F: GMT Ratio V116 Lot 2/V116 Lot 3||1.10|0.80|<0.001
73821190|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.17||Identical p-values for the lower and upper bounds.|cDLA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 2||1.17|0.85|<0.001
73821191|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.86|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 3||1.19|0.86|<0.001
73821192|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 23A: GMT Ratio V116 Lot 2/V116 Lot 3||1.19|0.87|<0.001
73821193|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|1.0|1.48||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 2||1.48|1.00|<0.001
73821194|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.8|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 3||1.19|0.80|<0.001
73821195|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.66|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 23B: GMT Ratio V116 Lot 2/V116 Lot 3||0.97|0.66|<0.001
73821196|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 2||1.18|0.88|<0.001
73821197|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 3||1.18|0.88|<0.001
73821198|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.87|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 24F: GMT Ratio V116 Lot 2/V116 Lot 3||1.16|0.87|<0.001
73821199|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 2||1.20|0.87|<0.001
73821200|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 3||1.20|0.87|<0.001
73821201|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 31: GMT Ratio V116 Lot 2/V116 Lot 3||1.17|0.85|<0.001
73821202|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.11|||<|0.001|TWO_SIDED|95.0|0.93|1.33||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 2||1.33|0.93|<0.001
73821203|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.9|1.29||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 3||1.29|0.90|<0.001
73821204|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.81|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 33F: GMT Ratio V116 Lot 2/V116 Lot 3||1.16|0.81|<0.001
73821205|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 2||1.17|0.91|<0.001
73821206|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.91|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 3||1.18|0.91|<0.001
73821207|NCT05464420|147189790|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.89|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 35B: GMT Ratio V116 Lot 2/V116 Lot 3||1.14|0.89|<0.001
73821208|NCT05464420|147189791|OTHER||GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||V116 Combined Lots/PPSV23|Serotype 3: GMT Ratio V116 Combined Lots/ PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.03|0.84|
73821209|NCT05464420|147189791|OTHER||GMT Ratio|3.48|||||TWO_SIDED|95.0|3.01|4.02|||||V116 Combined Lots/PPSV23|Serotype 6A: GMT Ratio V116 Combined Lots/ PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.02|3.01|
73821210|NCT05464420|147189791|OTHER||GMT Ratio|1.33|||||TWO_SIDED|95.0|1.18|1.49|||||V116 Combined Lots/PPSV23|Serotype 7F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.49|1.18|
73821211|NCT05464420|147189791|OTHER||GMT Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.93|||||V116 Combined Lots/PPSV23|Serotype 8: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|0.93|0.77|
73821212|NCT05464420|147189791|OTHER||GMT Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.08|||||V116 Combined Lots/PPSV23|Serotype 9N: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.08|0.85|
73821213|NCT05464420|147189791|OTHER||GMT Ratio|1.32|||||TWO_SIDED|95.0|1.18|1.48|||||V116 Combined Lots/PPSV23|Serotype 10A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.48|1.18|
73821214|NCT05464420|147189791|OTHER||GMT Ratio|1.74|||||TWO_SIDED|95.0|1.56|1.95|||||V116 Combined Lots/PPSV23|Serotype 11A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.95|1.56|
73821215|NCT05464420|147189791|OTHER||GMT Ratio|1.38|||||TWO_SIDED|95.0|1.22|1.56|||||V116 Combined Lots/PPSV23|Serotype 12F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.56|1.22|
73821216|NCT05464420|147189791|OTHER||GMT Ratio|4.03|||||TWO_SIDED|95.0|3.56|4.56|||||V116 Combined Lots/PPSV23|Serotype 15A: GMT Ratio v116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.56|3.56|
73821217|NCT05464420|147189791|OTHER||GMT Ratio|2.9|||||TWO_SIDED|95.0|2.49|3.38|||||V116 Combined Lots/PPSV23|Serotype 15C: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|3.38|2.49|
73821218|NCT05464420|147189791|OTHER||GMT Ratio|3.72|||||TWO_SIDED|95.0|3.32|4.17||||||Serotype 16F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.17|3.32|
73821219|NCT05464420|147189791|OTHER||GMT Ratio|1.71|||||TWO_SIDED|95.0|1.53|1.91|||||V116 Combined Lots/PPSV23|Serotype 17F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.91|1.53|
73821220|NCT05464420|147189791|OTHER||GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||V116 Combined Lots/PPSV23|Serotype 19A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.03|0.84|
73821221|NCT05464420|147189791|OTHER||GMT Ratio|1.47|||||TWO_SIDED|95.0|1.3|1.67|||||V116 Combined Lots/PPSV23|Serotype 20A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.67|1.30|
73821222|NCT05464420|147189791|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.17|1.53|||||V116 Combined Lots/PPSV23|Serotype 22F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.53|1.17|
73821223|NCT05464420|147189791|OTHER||GMT Ratio|7.98|||||TWO_SIDED|95.0|6.84|9.31|||||V116 Combined Lots/PPSV23|Serotype 23A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|9.31|6.84|
73821224|NCT05464420|147189791|OTHER||GMT Ratio|23.72|||||TWO_SIDED|95.0|19.71|28.55|||||V116 Combined Lots/PPSV23|Serotype 23B: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|28.55|19.71|
73821225|NCT05464420|147189791|OTHER||GMT Ratio|19.55|||||TWO_SIDED|95.0|16.7|22.88|||||V116 Combined Lots/PPSV23|Serotype 24F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|22.88|16.70|
73821226|NCT05464420|147189791|OTHER||GMT Ratio|13.55|||||TWO_SIDED|95.0|11.68|15.71|||||V116 Combined Lots/PPSV23|Serotype 31: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|15.71|11.68|
73821227|NCT05464420|147189791|OTHER||GMT Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.97||||||Serotype 33F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|0.97|0.73|
73821228|NCT05464420|147189791|OTHER||GMT Ratio|3.71|||||TWO_SIDED|95.0|3.36|4.09|||||V116 Combined Lots/PPSV23|Serotype 35B: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.09|3.36|
73821229|NCT05464420|147189792|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.88|1.09|||||V116 Lot 1/V116 Lot 2|Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.09|0.88|
73821230|NCT05464420|147189792|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.05|||||V116 Lot 1/V116 Lot 3|Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.85|
73821231|NCT05464420|147189792|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.87|1.08|||||V116 Lot 2/V116 Lot 3|Serotype 3: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.08|0.87|
73821232|NCT05464420|147189792|OTHER||GMC Ratio|1.12|||||TWO_SIDED|95.0|0.95|1.32|||||V116 Lot 1/V116 Lot 2|Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.32|0.95|
73821233|NCT05464420|147189792|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.2|||||V116 Lot 1/V116 Lot 3|Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.20|0.86|
73821234|NCT05464420|147189792|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.77|1.07|||||V116 Lot 2/V116 Lot 3|Serotype 6A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.77|
73821235|NCT05464420|147189792|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||||V116 Lot 1/V116 Lot 2|Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.85|
73821236|NCT05464420|147189792|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.9|1.18|||||V116 Lot 1/V116 Lot 3|Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.90|
73821237|NCT05464420|147189792|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.93|1.21|||||V116 Lot 2/V116 Lot 3|Serotype 7F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.93|
73821238|NCT05464420|147189792|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.12|||||V116 Lot 1/V116 Lot 2|Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.12|0.86|
73821239|NCT05464420|147189792|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
73821240|NCT05464420|147189792|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 8: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.89|
73821241|NCT05464420|147189792|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
73821242|NCT05464420|147189792|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.03|||||V116 Lot 1/V116 Lot 3|Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.03|0.77|
73821243|NCT05464420|147189792|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.74|0.98|||||V116 Lot 2/V116 Lot 3|Serotype 9N: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|0.98|0.74|
73821244|NCT05464420|147189792|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||V116 Lot 1/V116 Lot 2|Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.87|
73821245|NCT05464420|147189792|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.83|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.83|
73821246|NCT05464420|147189792|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.11|||||V116 Lot 2/V116 Lot 3|Serotype 10A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.82|
73821247|NCT05464420|147189792|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||V116 Lot 1/V116 Lot 2|Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.90|
73821248|NCT05464420|147189792|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.91|
73821249|NCT05464420|147189792|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||V116 Lot 2/V116 Lot 3|Serotype 11A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.90|
73821250|NCT05464420|147189792|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.12|||||V116 Lot 1/V116 Lot 2|Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.12|0.80|
73821251|NCT05464420|147189792|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.18|||||V116 Lot 1/V116 Lot 3|Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.84|
73821252|NCT05464420|147189792|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.89|1.25|||||V116 Lot 2/V116 Lot 3|Serotype 12F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.25|0.89|
73821253|NCT05464420|147189792|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
73821254|NCT05464420|147189792|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.83|1.11|||||V116 Lot 1/V116 Lot 3|Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.83|
73821255|NCT05464420|147189792|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05|||||V116 Lot 2/V116 Lot 3|Serotype 15A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.80|
73821256|NCT05464420|147189792|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.91|1.23|||||V116 Lot 1/V116 Lot 2|Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.23|0.91|
73821257|NCT05464420|147189792|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.89|1.2|||||V116 Lot 1/V116 Lot 3|Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.20|0.89|
73821258|NCT05464420|147189792|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.14|||||V116 Lot 2/V116 Lot 3|Serotype 15C: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.84|
73821259|NCT05464420|147189792|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.03|||||V116 Lot 1/V116 Lot 2|Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.03|0.78|
73821260|NCT05464420|147189792|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.04|||||V116 Lot 1/V116 Lot 3|Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.04|0.78|
73821261|NCT05464420|147189792|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.88|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 16F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.88|
73821262|NCT05464420|147189792|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
73821263|NCT05464420|147189792|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.23|||||V116 Lot 1/V116 Lot 3|Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.23|0.93|
73821264|NCT05464420|147189792|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.88|1.17|||||V116 Lot 2/V116 Lot 3|Serotype 17F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.88|
73821265|NCT05464420|147189792|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||||V116 Lot 1/V116 Lot 2|Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.85|
73821266|NCT05464420|147189792|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.04|||||V116 Lot 1/V116 Lot 3|Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.04|0.79|
73821267|NCT05464420|147189792|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.82|1.07|||||V116 Lot 2/V116 Lot 3|Serotype 19A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.82|
73821268|NCT05464420|147189792|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.1|||||V116 Lot 1/V116 Lot 2|Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.83|
73821269|NCT05464420|147189792|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||V116 Lot 1/V116 Lot 3|Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
73821270|NCT05464420|147189792|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.88|1.16|||||V116 Lot 2/V116 Lot 3|Serotype 20A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.88|
73821271|NCT05464420|147189792|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.87|
73821272|NCT05464420|147189792|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.16|||||V116 Lot 1/V116 Lot 3|Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.87|
73821273|NCT05464420|147189792|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.86|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 22F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.86|
73821274|NCT05464420|147189792|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.84|
73821275|NCT05464420|147189792|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.83|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.83|
73821276|NCT05464420|147189792|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.85|1.17|||||V116 Lot 2/V116 Lot 3|Serotype 23A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.85|
73821277|NCT05464420|147189792|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.87|1.18|||||V116 Lot 1/V116 Lot 2|Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.87|
73821278|NCT05464420|147189792|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||V116 Lot 1/V116 Lot 3|Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.79|
73821279|NCT05464420|147189792|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.05|||||V116 Lot 2/V116 Lot 3|Serotype 23B: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.77|
73821280|NCT05464420|147189792|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.13|||||V116 Lot 1/V116 Lot 2|Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.80|
73821281|NCT05464420|147189792|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.19|||||V116 Lot 1/V116 Lot 3|Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.19|0.84|
73821282|NCT05464420|147189792|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.25|||||V116 Lot 2/V116 Lot 3|Serotype 24F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.25|0.88|
73821283|NCT05464420|147189792|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.77|1.0|||||V116 Lot 1/V116 Lot 2|Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.00|0.77|
73821284|NCT05464420|147189792|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.14|||||V116 Lot 1/V116 Lot 3|Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.88|
73821285|NCT05464420|147189792|OTHER||GMC Ratio|1.14|||||TWO_SIDED|95.0|1.0|1.3|||||V116 Lot 2/V116 Lot 3|Serotype 31: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.30|1.00|
73821286|NCT05464420|147189792|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.89|
73821287|NCT05464420|147189792|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.88|
73821288|NCT05464420|147189792|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 2/V116 Lot 3|Serotype 33F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
73821289|NCT05464420|147189792|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.9|1.17|||||V116 Lot 1/V116 Lot 2|Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.90|
73821290|NCT05464420|147189792|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
73821291|NCT05464420|147189792|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1|||||V116 Lot 2/V116 Lot 3|Serotype 35B: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.85|
73821292|NCT05464420|147189793|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|1.01|1.21|||||V116 Combined Lots/PPSV23|Serotype 3: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|1.01|
73821293|NCT05464420|147189793|OTHER||GMC Ratio|3.91|||||TWO_SIDED|95.0|3.43|4.45|||||V116 Combined Lots/PPSV23|Serotype 6A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|4.45|3.43|
73821294|NCT05464420|147189793|OTHER||GMC Ratio|1.54|||||TWO_SIDED|95.0|1.38|1.72|||||V116 Combined Lots/PPSV23|Serotype 7F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.72|1.38|
73821295|NCT05464420|147189793|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.73|0.89|||||V116 Combined Lots/PPSV23|Serotype 8: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|0.89|0.73|
73821296|NCT05464420|147189793|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.14|||||V116 Combined Lots/PPSV23|Serotype 9N: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.91|
73821297|NCT05464420|147189793|OTHER||GMC Ratio|1.47|||||TWO_SIDED|95.0|1.3|1.66|||||V116 Combined Lots/PPSV23|Serotype 10A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.66|1.30|
73821298|NCT05464420|147189793|OTHER||GMC Ratio|1.38|||||TWO_SIDED|95.0|1.26|1.52|||||V116 Combined Lots/PPSV23|Serotype 11A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.52|1.26|
73821299|NCT05464420|147189793|OTHER||GMC Ratio|1.41|||||TWO_SIDED|95.0|1.23|1.62|||||V116 Combined Lots/PPSV23|Serotype 12F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.62|1.23|
73821300|NCT05464420|147189793|OTHER||GMC Ratio|6.82|||||TWO_SIDED|95.0|6.08|7.65|||||V116 Combined Lots/PPSV23|Serotype 15A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.65|6.08|
73821301|NCT05464420|147189793|OTHER||GMC Ratio|3.24|||||TWO_SIDED|95.0|2.86|3.67|||||V116 Combined Lots/PPSV23|Serotype 15C: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|3.67|2.86|
73821302|NCT05464420|147189793|OTHER||GMC Ratio|6.48|||||TWO_SIDED|95.0|5.83|7.19|||||V116 Combined Lots/PPSV23|Serotype 16F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.19|5.83|
73821303|NCT05464420|147189793|OTHER||GMC Ratio|1.85|||||TWO_SIDED|95.0|1.66|2.07|||||V116 Combined Lots/PPSV23|Serotype 17F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|2.07|1.66|
73821304|NCT05464420|147189793|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.98|1.22|||||V116 Combined Lots/PPSV23|Serotype 19A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.22|0.98|
73821305|NCT05464420|147189793|OTHER||GMC Ratio|1.53|||||TWO_SIDED|95.0|1.37|1.71|||||V116 Combined Lots/PPSV23|Serotype 20A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.71|1.37|
73821306|NCT05464420|147189793|OTHER||GMC Ratio|1.32|||||TWO_SIDED|95.0|1.17|1.49|||||V116 Combined Lots/PPSV23|Serotype 22F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.49|1.17|
73821307|NCT05464420|147189793|OTHER||GMC Ratio|8.14|||||TWO_SIDED|95.0|7.19|9.23|||||V116 Combined Lots/PPSV23|Serotype 23A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|9.23|7.19|
73821308|NCT05464420|147189793|OTHER||GMC Ratio|5.74|||||TWO_SIDED|95.0|5.08|6.48|||||V116 Combined Lots/PPSV23|Serotype 23B: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|6.48|5.08|
73821309|NCT05464420|147189793|OTHER||GMC Ratio|14.47|||||TWO_SIDED|95.0|12.77|16.4|||||V116 Combined Lots/PPSV23|Serotype 24F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|16.40|12.77|
73821310|NCT05464420|147189793|OTHER||GMC Ratio|9.55|||||TWO_SIDED|95.0|8.61|10.59|||||V116 Combined Lots/PPSV23|Serotype 31: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|10.59|8.61|
73821311|NCT05464420|147189793|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.73|0.91|||||V116 Combined Lots/PPSV23|Serotype 33F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|0.91|0.73|
73821312|NCT05464420|147189793|OTHER||GMC Ratio|7.06|||||TWO_SIDED|95.0|6.41|7.77|||||V116 Combined Lots/PPSV23|Serotype 35B: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.77|6.41|
73821313|NCT02716584|147189817|SUPERIORITY||Effect size|0.41||||0.02|TWO_SIDED||||||ANCOVA|||Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of exercise sessions attended as a covariate.||||0.02
73821314|NCT02716584|147189818|SUPERIORITY||Effect size|0.35||||0.06|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.06
73821315|NCT02716584|147189819|SUPERIORITY|||||||0.13|||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.13
73821316|NCT02716584|147189820|SUPERIORITY||Effect size|0.19||||0.73|TWO_SIDED|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.73
73821317|NCT02716584|147189820|SUPERIORITY||Effect size|0.73||||0.33|TWO_SIDED|||||For cohort 3, positive affect was measured at baseline and a midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||.33
73821318|NCT02716584|147189821|SUPERIORITY||Effect size|-0.21||||0.62|TWO_SIDED|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.62
73821319|NCT02716584|147189821|SUPERIORITY||Effect size|0.77||||0.23|TWO_SIDED|||||For cohort 3, positive affect was measured at a baseline and midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||.23
73821320|NCT02716584|147189822|SUPERIORITY||Effect size|0.02||||0.57|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.57
73821321|NCT02716584|147189823|SUPERIORITY||Effect size|0.35||||0.12|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.12
73821322|NCT02716584|147189824|SUPERIORITY||Effect size|0.72||||0.07|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.07
73821323|NCT02716584|147189825|SUPERIORITY||Effect size|0.0||||0.88|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.88
73821324|NCT02716584|147189826|SUPERIORITY||Effect size|0.05||||0.86|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.86
73821325|NCT01903993|147189827|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||=|0.0106|TWO_SIDED|95.0|0.52|0.92|||Log rank (Stratified)|||Hazard ratios (HR) were estimated by a Cox regression model.||0.92|0.52|= 0.0106
73821326|NCT01903993|147189828|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|0.59|||=|0.8884|TWO_SIDED|95.0|-7.67|8.85|||Cochran-Mantel-Haenszel|||||8.85|-7.67|= 0.8884
73821327|NCT01903993|147189829|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||=|0.5563|TWO_SIDED|95.0|0.71|1.2|||Log rank (Stratified)|||HR were estimated by a Cox regression model. The two treatment comparison was based on a stratified log-rank test.||1.20|0.71|=0.5563
73821328|NCT01903993|147189830|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.32|||=|0.0028|TWO_SIDED|95.0|0.15|0.7|||Log rank (unstratified)|||HR were estimated by a unstratified Cox regression model.||0.70|0.15|= 0.0028
73821329|NCT01243177|147189858|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The hypothesis was as follows:~H0: \[S(t)LCM\] - \[S(t)CBZ-CR\] ≤ -12 % versus HA: \[S(t)LCM\] - \[S(t)CBZ-CR\] \> -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.5|2.8|||Mantel Haenszel|The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and \>2).|The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.||2.8|-5.5|
73821330|NCT01243177|147189859|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The hypothesis was as follows:~H0: \[S(t)LCM\] - \[S(t)CBZ-CR\] ≤ -12 % versus HA: \[S(t)LCM\] - \[S(t)CBZ-CR\] \> -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.3|2.7|||Mantel Haenszel|The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and \>2).|The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.||2.7|-5.3|
73821331|NCT01677182|147189909|SUPERIORITY_OR_OTHER||Least Squares Mean Differences|0.8|STANDARD_ERROR_OF_MEAN|0.98||0.783|TWO_SIDED|97.5|-1.4|3.0||Mixed Model Repeated Measures (MMRM) model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||3.0|-1.4|0.783
73821332|NCT01677182|147189909|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.97||0.329|TWO_SIDED|97.5|-2.6|1.7||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.7|-2.6|0.329
73821333|NCT01677182|147189910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.27||0.088|TWO_SIDED|97.5|-0.1|1.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.1|-0.1|0.088
73821334|NCT01677182|147189910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.642|TWO_SIDED|97.5|-0.7|0.5||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.5|-0.7|0.642
73821335|NCT01677182|147189911|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.792|TWO_SIDED|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.3|-0.2|0.792
73821336|NCT01677182|147189911|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.171|TWO_SIDED|97.5|-0.4|0.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.1|-0.4|0.171
73821337|NCT01677182|147189912|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.653|TWO_SIDED|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.3|-0.2|0.653
73821338|NCT01677182|147189912|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.673|TWO_SIDED|97.5|-0.3|0.2||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.2|-0.3|0.673
73821339|NCT01677182|147189913|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.51||0.119|TWO_SIDED|97.5|-0.4|2.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.0|-0.4|0.119
73821340|NCT01677182|147189913|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.791|TWO_SIDED|97.5|-1.3|1.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.0|-1.3|0.791
73821341|NCT01677182|147189914|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.422|TWO_SIDED|97.5|-1.0|2.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.1|-1.0|0.422
73821342|NCT01677182|147189914|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.655|TWO_SIDED|97.5|-1.3|1.9||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.9|-1.3|0.655
73821343|NCT01677182|147189915|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.64||0.696|TWO_SIDED|97.5|-4.5|2.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.8|-4.5|0.696
73821344|NCT01677182|147189915|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.63||0.472|TWO_SIDED|97.5|-3.6|3.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||3.8|-3.6|0.472
73821345|NCT01677182|147189916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.998||||0.994|TWO_SIDED|95.0|0.651|1.53||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.530|0.651|0.994
73821346|NCT01677182|147189916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.886||||0.575|TWO_SIDED|95.0|0.58|1.352||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.352|0.580|0.575
73821347|NCT01677182|147189917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.978||||0.927|TWO_SIDED|95.0|0.606|1.577||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.577|0.606|0.927
73821348|NCT01677182|147189917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.865||||0.553|TWO_SIDED|95.0|0.536|1.397||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.397|0.536|0.553
73821349|NCT00995722|147189919|NON_INFERIORITY_OR_EQUIVALENCE|N=80, (40 per group), 80% power to detect a group difference of 30%-35% and 5% significance level.|Mean Difference (Final Values)|-2.2||||0.37|TWO_SIDED|95.0|-7.2|2.8|||ANCOVA|ANCOVA used to compare mean values adjusting for the baseline value|QMG Score ranges from 0-15, where 0 is normal and a reduction in score represents imrovement.|Mean Ocular QMG Changes from Baseline to Week 16 . 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||2.8|-7.20|0.37
73821350|NCT00995722|147189920|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment|Mean Difference (Net)|6.56||||0.13|TWO_SIDED|95.0|-2.59|15.71|||ANCOVA||Scores ranges fro 0-100 , where 100 is normal and an increase in score represents an improvement|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||15.71|-2.59|0.13
73821351|NCT00995722|147189921|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment|Mean Difference (Final Values)|-3.81||||0.15|TWO_SIDED|95.0|-9.37|1.75|||ANCOVA||Ranges from 0-60, where 0 is Normal and a reduction in score represents improvement.|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||1.75|-9.37|0.15
73821352|NCT00995722|147189922|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16.|Mean Difference (Final Values)|16.98||||0.16|TWO_SIDED|95.0|-9.22|43.17|||ANCOVA||Ranges 0-100, where 100 is normal and an increase in score represents an improvement.|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||43.17|-9.22|0.16
73821353|NCT00762762|147189927|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
73821354|NCT00762762|147189928|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
73821355|NCT00762762|147189929|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
73821356|NCT00762762|147189930|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
73821357|NCT00762762|147189931|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
73821358|NCT00762762|147189932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73821359|NCT00762762|147189933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73821360|NCT00762762|147189934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73821361|NCT00762762|147189935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73821362|NCT00762762|147189936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73821363|NCT02861664|147189958|OTHER||Least square (LS) mean difference|-0.6|||<|0.0001||95.0|-0.8|-0.4||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-0.4|-0.8|<.0001
73821364|NCT01563198|147189961|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Change in Non-completion Rate of MRI Scans From Baseline at Average of One Year (All Schedule Patients)||||<0.0001
73821365|NCT01563198|147189962|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73821366|NCT01563198|147189963|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
73821367|NCT02781818|147189964|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
73821368|NCT02781818|147189964|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
73821369|NCT02781818|147189965|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|||||||.65
73821370|NCT02781818|147189965|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
73821371|NCT02781818|147189966|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.50
73821372|NCT02781818|147189966|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
73821373|NCT00707057|147189973|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null versus alternative hypothesis regarding the analgesic efficacy using the SPID 8-12 was compared between the 2 treatment groups using an analysis of covariance (ANCOVA)model with each subject's outcome being his/her SPID 8-12 as the dependent variable in the ANCOVA model with terms for gender, treatment, and baseline pain score categories (stratified as ≤7 and \>7).||||<0.0001
73821374|NCT00707057|147189974|SUPERIORITY_OR_OTHER||||||<|0.0017||95.0|||||ANCOVA|||The null versus alternative hypothesis regarding the durability of analgesic efficacy using the PID scores at 24, 36, and 48 hours.An individual subject was to achieve the 2-point reduction at all 3 terminal time points in order to be defined as responder.||||<0.0017
73821375|NCT00707057|147189975|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.||||<0.0001
73821376|NCT00707057|147189976|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.||||<0.0001
73821377|NCT00707057|147189977|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73821378|NCT00707057|147189978|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73821379|NCT00707057|147189978|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Estimated Confidence Interval: 95%Method: Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel|||||||<0.0001
73896529|NCT03456882|147326401|SUPERIORITY||Mean Difference (Net)|16.7|STANDARD_ERROR_OF_MEAN|19.7||0.3985|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.3985
73896530|NCT03456882|147326402|SUPERIORITY|||||||0.2543||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.2543
73821380|NCT00707057|147189979|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|With terms for treatment, gender, and baseline pain score categories stratified as ≤7 and \>7.||The PID at each time point prior to dose 2 was derived by substracting the pain intensity from the base line pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval. Time weighted TOTPAR for ech specified interval was similarly derived.||||<0.0001
73821381|NCT00707057|147189980|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
73821382|NCT00707057|147189981|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||The proportions of subjects who rescued at or prior to hour 8, hour 10, and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.||||<0.0001
73821383|NCT00707057|147189982|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The pain relief and PID scores at individual time points were summarized by descriptive statistics. The test and reference were compared at each individual time point at 24, 36 and 48 hours.||||<0.0001
73821384|NCT00707057|147189983|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation for dose 1, either at the time of rescue or at dose 2 whichever came first were summarized by descriptive statistics based on non-missing data. The range went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS).||||<0.0001
73821385|NCT00707057|147189984|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P- value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Global evaluation scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide global evaluation of dose 2 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief."||||<0.0001
73821386|NCT00707057|147189984|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain scores categories.|ANCOVA|||"Maximum relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide maximum relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."||||<0.0001
73821387|NCT00707057|147189984|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Overall relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide overall relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."||||<0.0001
73821388|NCT00707057|147189985|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 3 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.||||<0.0001
73821389|NCT00707057|147189985|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and basee pain score categories.|ANCOVA|||Maximum relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
73821390|NCT00707057|147189985|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
73821391|NCT00707057|147189986|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 4 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.||||<0.0001
73821392|NCT00707057|147189986|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Maximum relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
73821393|NCT00707057|147189986|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
73821394|NCT04611542|147189987|SUPERIORITY||Mean Difference (Final Values)|1.02|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73821395|NCT04611542|147189988|SUPERIORITY||Median Difference (Final Values)|1.12|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
73821396|NCT04611542|147189989|SUPERIORITY||Mean Difference (Final Values)|6.32|||<|0.001|TWO_SIDED||||||t-test, 2 sided||Investigators tested whether pretest to posttest change was significantly greater than 0 at P \< 0.05.|||||<0.001
73821397|NCT00320242|147189990|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|0.48||0.0152|TWO_SIDED|95.0|0.26|2.23|||t-test, 2 sided|two-tailed paired t-test||||2.23|0.26|0.0152
73821398|NCT00320242|147189991|SUPERIORITY||Mean Difference (Final Values)|50.0|STANDARD_ERROR_OF_MEAN|11.7||0.005|TWO_SIDED|95.0|23.9|76.1|||t-test, 2 sided|||||76.1|23.9|0.005
73821399|NCT00320242|147189992|SUPERIORITY||Mean Difference (Net)|1.11|STANDARD_DEVIATION|1.31||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-tailed Wilcoxan signed-rank sum test||two-tailed Wilcoxan signed-rank sum test||||0.02
73821400|NCT00320242|147189993|OTHER|The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0||||||0.002||||||Two-tailed one-sample t-test with a hypothesized mean of 0. This analysis was not adjusted for multiple comparisons.|t-test, 2 sided|||The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0||||0.002
73821401|NCT00472732|147189994|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in posterior cingulate gray matter will be the same in OTCD patients as in controls.||||0.003
73821402|NCT00472732|147189994|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in parietal white matter will be the same in OTCD patients as in controls.||||<0.001
73821403|NCT00472732|147189994|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in posterior cingulate gray matter would be the same for OTCD patients as for controls.||||0.001
73821404|NCT00472732|147189994|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in parietal white matter would be the same for OTCD patients as for controls.||||<0.001
73821405|NCT00472732|147189995|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This p-value is adjusted for family wise error rate correction.|t-test, 2 sided|||Two-way between-group t-tests restricted to the prefrontal cortex were performed to compare activation during for the 2-Back\> 1-Back contrast between OTCD patients and controls.||||<0.05
73821406|NCT00472732|147189996|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis predicted that fractional anisotropy, a marker of white matter integrity, would be the same for OTCD patients as for controls.||||<0.001
73821407|NCT00572455|147189998|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|3.02||||0.028|TWO_SIDED|90.0|0.78|5.25|||ANCOVA|||Analysis was based on analysis of covariance (ANCOVA) model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.25|0.78|0.028
73821408|NCT00572455|147189998|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.73|||<|0.001|TWO_SIDED|90.0|2.5|6.96|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.96|2.50|<0.001
73821409|NCT00572455|147189998|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.56|||<|0.001|TWO_SIDED|90.0|4.33|8.79|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.79|4.33|<0.001
73821410|NCT00572455|147189998|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.78|||<|0.001|TWO_SIDED|90.0|3.6|7.95|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.95|3.60|<0.001
73821411|NCT00572455|147189998|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.06|||<|0.001|TWO_SIDED|90.0|2.74|7.37|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.37|2.74|<0.001
73821412|NCT00572455|147189998|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.02|||<|0.001|TWO_SIDED|90.0|3.79|8.25|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.25|3.79|<0.001
73821413|NCT00572455|147189999|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.06||||0.171|TWO_SIDED|90.0|-0.21|2.32|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.32|-0.21|0.171
73821414|NCT00572455|147189999|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.45||||0.553|TWO_SIDED|90.0|-0.8|1.7|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.70|-0.80|0.553
73821415|NCT00572455|147189999|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.45||||0.555|TWO_SIDED|90.0|-0.8|1.7|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.70|-0.80|0.555
73821416|NCT00572455|147189999|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.48||||0.053|TWO_SIDED|90.0|0.22|2.73|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.73|0.22|0.053
73821417|NCT00572455|147189999|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.54|||<|0.001|TWO_SIDED|90.0|1.29|3.8|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.80|1.29|<0.001
73821418|NCT00572455|147189999|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.81||||0.018|TWO_SIDED|90.0|0.56|3.07|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to Latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.07|0.56|0.018
73821419|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.62||||0.011|TWO_SIDED|90.0|1.34|5.9|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.90|1.34|0.011
73821420|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.19||||0.004|TWO_SIDED|90.0|1.91|6.47|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.47|1.91|0.004
73821421|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.47|||<|0.001|TWO_SIDED|90.0|4.19|8.75|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.75|4.19|<0.001
73821422|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.32|||<|0.001|TWO_SIDED|90.0|3.11|7.54|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.54|3.11|<0.001
73821423|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.0|||<|0.001|TWO_SIDED|90.0|3.66|8.33|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.33|3.66|<0.001
73821424|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.8|||<|0.001|TWO_SIDED|90.0|3.52|8.08|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.08|3.52|<0.001
73821425|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.44||||0.12|TWO_SIDED|90.0|-0.14|5.02|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.02|-0.14|0.120
73821426|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.55||||0.005|TWO_SIDED|90.0|1.97|7.14|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.14|1.97|0.005
73821427|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.17|||<|0.001|TWO_SIDED|90.0|3.58|8.75|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.75|3.58|<0.001
73821428|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.03|||<|0.001|TWO_SIDED|90.0|3.52|8.54|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.54|3.52|<0.001
73821429|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.31|||<|0.001|TWO_SIDED|90.0|4.66|9.95|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.95|4.66|<0.001
73821430|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.5|||<|0.001|TWO_SIDED|90.0|2.91|8.08|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its Vehicle with treatment and baseline IOP as covariates.||8.08|2.91|<0.001
73821431|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.04||||0.009|TWO_SIDED|90.0|1.56|6.53|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.53|1.56|0.009
73821432|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.0|||<|0.001|TWO_SIDED|90.0|4.49|9.5|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.50|4.49|<0.001
73821433|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.61|||<|0.001|TWO_SIDED|90.0|5.11|10.11|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||10.11|5.11|<0.001
73821434|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.08|||<|0.001|TWO_SIDED|90.0|4.64|9.53|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.53|4.64|<0.001
73821435|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.01|||<|0.001|TWO_SIDED|90.0|3.4|8.62|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.62|3.40|<0.001
73821436|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.7|||<|0.001|TWO_SIDED|90.0|6.11|11.3|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||11.30|6.11|<0.001
73821437|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.66||||0.066|TWO_SIDED|90.0|0.29|5.02|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.02|0.29|0.066
73821438|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.13||||0.006|TWO_SIDED|90.0|1.76|6.5|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.50|1.76|0.006
73821439|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.13|||<|0.001|TWO_SIDED|90.0|3.76|8.49|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.49|3.76|<0.001
73821440|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.81|||<|0.001|TWO_SIDED|90.0|3.51|8.11|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.11|3.51|<0.001
73821441|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.02||||0.01|TWO_SIDED|90.0|1.53|6.5|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.50|1.53|0.010
73821442|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.48|||<|0.001|TWO_SIDED|90.0|3.03|7.93|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.93|3.03|<0.001
73821443|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.55||||0.006|TWO_SIDED|90.0|1.91|7.19|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.19|1.91|0.006
73821444|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.3||||0.002|TWO_SIDED|90.0|2.66|7.94|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.94|2.66|0.002
73821445|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.51|||<|0.001|TWO_SIDED|90.0|4.87|10.16|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||10.16|4.87|<0.001
73821446|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.14|||<|0.001|TWO_SIDED|90.0|6.57|11.71|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||11.71|6.57|<0.001
73821447|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.69||||0.002|TWO_SIDED|90.0|2.94|8.44|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.44|2.94|0.002
73821448|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.89|||<|0.001|TWO_SIDED|90.0|4.16|9.62|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.62|4.16|<0.001
73821449|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83||||0.269|TWO_SIDED|90.0|-0.91|4.58|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||4.58|-0.91|0.269
73821450|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.49||||0.009|TWO_SIDED|90.0|1.75|7.24|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.24|1.75|0.009
73821451|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.83|||<|0.001|TWO_SIDED|90.0|4.08|9.57|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.57|4.08|<0.001
73821452|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.18|||<|0.001|TWO_SIDED|90.0|3.52|8.84|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.84|3.52|<0.001
73821453|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.52||||0.002|TWO_SIDED|90.0|2.71|8.33|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.33|2.71|0.002
73821454|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.76|||<|0.001|TWO_SIDED|90.0|4.01|9.5|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.50|4.01|<0.001
73821455|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.36||||0.024|TWO_SIDED|90.0|0.95|5.76|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.76|0.95|0.024
73821456|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.24|||<|0.001|TWO_SIDED|90.0|2.82|7.66|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.66|2.82|<0.001
73821457|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.64|||<|0.001|TWO_SIDED|90.0|4.23|9.06|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.06|4.23|<0.001
73821458|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.22|||<|0.001|TWO_SIDED|90.0|2.87|7.58|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.58|2.87|<0.001
73821459|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.88||||0.012|TWO_SIDED|90.0|1.39|6.37|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.37|1.39|0.012
73821460|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.98|||<|0.001|TWO_SIDED|90.0|4.48|9.48|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.48|4.48|<0.001
73821461|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.41||||0.003|TWO_SIDED|90.0|2.11|6.72|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.72|2.11|0.003
73821462|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.02|||<|0.001|TWO_SIDED|90.0|2.72|7.33|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.33|2.72|<0.001
73821463|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.58|||<|0.001|TWO_SIDED|90.0|4.27|8.88|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.88|4.27|<0.001
73821464|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.54|||<|0.001|TWO_SIDED|90.0|3.31|7.78|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.78|3.31|<0.001
73821465|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.44||||0.003|TWO_SIDED|90.0|2.06|6.82|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.82|2.06|0.003
73821466|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.08|||<|0.001|TWO_SIDED|90.0|4.7|9.47|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.47|4.70|<0.001
73821467|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.41||||0.103|TWO_SIDED|90.0|-0.02|4.84|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||4.84|-0.02|0.103
73821468|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.75||||0.013|TWO_SIDED|90.0|1.32|6.18|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.18|1.32|0.013
73821469|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.96|||<|0.001|TWO_SIDED|90.0|3.53|8.39|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.39|3.53|<0.001
73821470|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.87|||<|0.001|TWO_SIDED|90.0|3.5|8.23|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.23|3.50|<0.001
73821471|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.65|||<|0.001|TWO_SIDED|90.0|3.18|8.11|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.11|3.18|<0.001
73821472|NCT00572455|147190003|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.97|||<|0.001|TWO_SIDED|90.0|3.46|8.48|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.48|3.46|<0.001
73821473|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.72||||0.377|TWO_SIDED|90.0|-0.63|2.08|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.08|-0.63|0.377
73821474|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.68||||0.039|TWO_SIDED|90.0|-3.01|-0.35|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||-0.35|-3.01|0.039
73821475|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34||||0.668|TWO_SIDED|90.0|-1.67|0.98|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.98|-1.67|0.668
73821476|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.26||||0.121|TWO_SIDED|90.0|-0.07|2.59|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.59|-0.07|0.121
73821477|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.67||||0.039|TWO_SIDED|90.0|0.34|2.99|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.99|0.34|0.039
73821478|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.99||||0.22|TWO_SIDED|90.0|-0.34|2.31|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.31|-0.34|0.220
73821479|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3||||0.098|TWO_SIDED|90.0|0.01|2.59|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.59|0.01|0.098
73821480|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.519|TWO_SIDED|90.0|-0.77|1.77|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.77|-0.77|0.519
73821481|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.724|TWO_SIDED|90.0|-1.0|1.55|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.55|-1.00|0.724
73821482|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.46||||0.059|TWO_SIDED|90.0|0.19|2.74|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.74|0.19|0.059
73821483|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.71|||<|0.001|TWO_SIDED|90.0|1.43|3.98|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.98|1.43|<0.001
73821484|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.09||||0.008|TWO_SIDED|90.0|0.82|3.37|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.37|0.82|0.008
73821485|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.32||||0.068|TWO_SIDED|90.0|0.13|2.51|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.51|0.13|0.068
73821486|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01||||0.994|TWO_SIDED|90.0|-1.16|1.18|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.18|-1.16|0.994
73821487|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.494|TWO_SIDED|90.0|-0.7|1.69|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.69|-0.70|0.494
73821488|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.39||||0.063|TWO_SIDED|90.0|0.16|2.62|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.62|0.16|0.063
73821489|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.15||||0.004|TWO_SIDED|90.0|0.95|3.34|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.34|0.95|0.004
73821490|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.17||||0.004|TWO_SIDED|90.0|0.97|3.38|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.38|0.97|0.004
73821491|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.55||||0.038|TWO_SIDED|90.0|0.32|2.77|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.77|0.32|0.038
73821492|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.48||||0.512|TWO_SIDED|90.0|-0.72|1.68|||ANCOVA|||Change at Day 7 1 PM : Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.68|-0.72|0.512
73821493|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.66||||0.373|TWO_SIDED|90.0|-0.56|1.89|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.89|-0.56|0.373
73821494|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31||||0.088|TWO_SIDED|90.0|0.05|2.56|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.56|0.05|0.088
73821495|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.21||||0.004|TWO_SIDED|90.0|0.98|3.44|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.44|0.98|0.004
73821496|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.33||||0.003|TWO_SIDED|90.0|1.09|3.57|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.57|1.09|0.003
73821497|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.87||||0.01|TWO_SIDED|90.0|0.69|3.04|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.04|0.69|0.010
73821498|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.89||||0.205|TWO_SIDED|90.0|-0.27|2.05|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.05|-0.27|0.205
73821499|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.44||||0.045|TWO_SIDED|90.0|0.26|2.63|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.63|0.26|0.045
73821500|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.09||||0.005|TWO_SIDED|90.0|0.88|3.31|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.31|0.88|0.005
73821501|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.51|||<|0.001|TWO_SIDED|90.0|1.33|3.7|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.70|1.33|<0.001
73821502|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.29||||0.002|TWO_SIDED|90.0|1.1|3.48|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.48|1.10|0.002
73821503|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.757|TWO_SIDED|90.0|-1.15|1.69|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.69|-1.15|0.757
73821504|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13||||0.878|TWO_SIDED|90.0|-1.54|1.27|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.27|-1.54|0.878
73821505|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24||||0.78|TWO_SIDED|90.0|-1.64|1.17|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.17|-1.64|0.780
73821506|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.36||||0.67|TWO_SIDED|90.0|-1.04|1.77|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.77|-1.04|0.670
73821507|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.98||||0.021|TWO_SIDED|90.0|0.58|3.38|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.38|0.58|0.021
73821508|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31||||0.126|TWO_SIDED|90.0|-0.1|2.71|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.71|-0.10|0.126
73821509|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.215|TWO_SIDED|90.0|-0.32|2.26|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.26|-0.32|0.215
73821510|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37||||0.635|TWO_SIDED|90.0|-1.65|0.91|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.91|-1.65|0.635
73821511|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06||||0.934|TWO_SIDED|90.0|-1.35|1.22|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.35|0.934
73821512|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56||||0.478|TWO_SIDED|90.0|-0.74|1.87|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.87|-0.74|0.478
73821513|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.57||||0.002|TWO_SIDED|90.0|1.26|3.87|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.87|1.26|0.002
73821514|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.99||||0.013|TWO_SIDED|90.0|0.68|3.3|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.30|0.68|0.013
73821515|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.736|TWO_SIDED|90.0|-1.04|1.57|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.57|-1.04|0.736
73821516|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68||||0.386|TWO_SIDED|90.0|-1.96|0.61|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.61|-1.96|0.386
73821517|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05||||0.948|TWO_SIDED|90.0|-1.35|1.24|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.24|-1.35|0.948
73821518|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.908|TWO_SIDED|90.0|-1.41|1.22|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.41|0.908
73821519|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.97||||0.015|TWO_SIDED|90.0|0.65|3.28|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.28|0.65|0.015
73821520|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6||||0.046|TWO_SIDED|90.0|0.29|2.92|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.92|0.29|0.046
73821521|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6||||0.042|TWO_SIDED|90.0|0.31|2.89|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.89|0.31|0.042
73821522|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06||||0.94|TWO_SIDED|90.0|-1.22|1.34|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.34|-1.22|0.940
73821523|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.24||||0.114|TWO_SIDED|90.0|-0.05|2.53|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.53|-0.05|0.114
73821524|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.228|TWO_SIDED|90.0|-0.35|2.28|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.28|-0.35|0.228
73821525|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.29||||0.005|TWO_SIDED|90.0|0.98|3.6|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.60|0.98|0.005
73821526|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.48||||0.063|TWO_SIDED|90.0|0.17|2.79|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.79|0.17|0.063
73821527|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.562|TWO_SIDED|90.0|-0.92|1.91|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.91|-0.92|0.562
73821528|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.67||||0.431|TWO_SIDED|90.0|-0.73|2.07|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.07|-0.73|0.431
73821529|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22||||0.795|TWO_SIDED|90.0|-1.18|1.62|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.62|-1.18|0.795
73821530|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83||||0.032|TWO_SIDED|90.0|0.43|3.23|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.23|0.43|0.032
73821531|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.73||||0.002|TWO_SIDED|90.0|1.34|4.13|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.13|1.34|0.002
73821532|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.04||||0.017|TWO_SIDED|90.0|0.64|3.44|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.44|0.64|0.017
73821533|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.26||||0.124|TWO_SIDED|90.0|-0.09|2.6|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.60|-0.09|0.124
73821534|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.08||||0.92|TWO_SIDED|90.0|-1.25|1.41|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.41|-1.25|0.920
73821535|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12||||0.887|TWO_SIDED|90.0|-1.46|1.22|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.46|0.887
73821536|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.42||||0.083|TWO_SIDED|90.0|0.08|2.77|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.77|0.08|0.083
73821537|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.65||||0.002|TWO_SIDED|90.0|1.29|4.01|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.01|1.29|0.002
73821538|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.3||||0.006|TWO_SIDED|90.0|0.94|3.66|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.66|0.94|0.006
73821539|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.49||||0.533|TWO_SIDED|90.0|-0.8|1.78|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.78|-0.80|0.533
73821540|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02||||0.985|TWO_SIDED|90.0|-1.29|1.26|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.26|-1.29|0.985
73821541|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34||||0.665|TWO_SIDED|90.0|-0.95|1.62|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.62|-0.95|0.665
73821542|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.86||||0.276|TWO_SIDED|90.0|-0.44|2.15|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.15|-0.44|0.276
73821543|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.34||||0.004|TWO_SIDED|90.0|1.04|3.65|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.65|1.04|0.004
73821544|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.04||||0.011|TWO_SIDED|90.0|0.74|3.35|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.35|0.74|0.011
73821545|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.78||||0.033|TWO_SIDED|90.0|0.41|3.14|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.14|0.41|0.033
73821546|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.84||||0.302|TWO_SIDED|90.0|-0.5|2.19|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.19|-0.50|0.302
73821547|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.94||||0.255|TWO_SIDED|90.0|-0.42|2.3|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.30|-0.42|0.255
73821548|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.08||||0.198|TWO_SIDED|90.0|-0.3|2.46|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.46|-0.30|0.198
73821549|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.68||||0.002|TWO_SIDED|90.0|1.3|4.06|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.06|1.30|0.002
73821550|NCT00572455|147190005|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.68||||0.046|TWO_SIDED|90.0|0.3|3.06|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.06|0.30|0.046
73821551|NCT02821416|147190011|SUPERIORITY||Median Difference (Final Values)|-5.81||||0.0208|TWO_SIDED|95.0|-10.69|-0.94|||Mixed Models Analysis|Model includes covariates of treatment, time post-allergen challenge , treatment\*time post-allergen challenge, allergen induced at screening||||-0.94|-10.69|0.0208
73821552|NCT02821416|147190012|SUPERIORITY||Median Difference (Final Values)|2.535||||0.363|TWO_SIDED|95.0|-3.045|8.116|||Mixed Models Analysis|Model includes covariates of treatment, maximum percent decrease in FEV1 late asthma response||||8.116|-3.045|0.3630
73821553|NCT04152083|147190013|OTHER||Hazard Ratio (HR)|1.54||||0.0006|TWO_SIDED|95.0|1.2|1.98||Threshold for significance at 0.05 level.|Likelihood ratio test|||The median estimate for each treatment group, hazard ratio, and its 95% confidence interval (CI) were based on the stratified Cox model with Efron's method of tie handling. The analysis was censored at the time point of first rescue medication. The stratification factors were concomitant migraine preventive treatment use and region.||1.98|1.20|0.0006
73821554|NCT04152083|147190014|OTHER||Hazard Ratio (HR)|1.75|||<|0.0001|TWO_SIDED|95.0|1.41|2.19||Threshold for significance at 0.05 level.|Likelihood ratio test|||The median estimate for each treatment group, hazard ratio, and its 95% CI were based on the stratified Cox model with Efron's method of tie handling. The analysis was censored at the time point of first rescue medication. The stratification factors were concomitant migraine preventive treatment use and region.||2.19|1.41|<0.0001
73821555|NCT04152083|147190015|OTHER||Odds Ratio (OR)|2.27||||0.0009|TWO_SIDED|95.0|1.39|3.72||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Odds ratio and 95% CI were based on Cochran-Mantel-Haenszel (CMH) test adjusted for the study's stratification factors of concomitant migraine preventive treatment use and region.||3.72|1.39|0.0009
73821556|NCT04152083|147190016|OTHER||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.55|3.25||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Odds ratio and 95% CI were based on CMH test adjusted for the study's stratification factors of concomitant migraine preventive treatment use and region.||3.25|1.55|<0.0001
73821557|NCT00856999|147190020|EQUIVALENCE|Non-parametric test equivalent to the dependent t-test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
73821558|NCT00856999|147190021|EQUIVALENCE|Non-parametric test equivalent to the dependent t-test|||||<|0.0004|||||||Wilcoxon (Mann-Whitney)|||||||<.0004
73821559|NCT00872521|147190022|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.09
73821560|NCT00872521|147190023|SUPERIORITY_OR_OTHER|||||||0.23|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.23
73821561|NCT00872521|147190024|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.23
73821562|NCT00872521|147190025|SUPERIORITY_OR_OTHER|||||||0.56|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.56
73821563|NCT00872521|147190026|SUPERIORITY_OR_OTHER|||||||0.01|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.01
73821564|NCT00872521|147190027|SUPERIORITY_OR_OTHER|||||||0.28|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.28
73821565|NCT04819438|147190037|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of Cmax geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|117.05|||<|0.0001|TWO_SIDED|90.0|110.43|124.06|||ANOVA|||||124.06|110.43|<0.0001
73821566|NCT04819438|147190038|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of AUC0-t geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|111.82|||<|0.0001|TWO_SIDED|90.0|108.25|115.5|||ANOVA|||||115.50|108.25|<0.0001
73821567|NCT04819438|147190040|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of AUC0-∞ geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|111.83|||<|0.0001|TWO_SIDED|90.0|108.19|115.29|||ANOVA|||||115.29|108.19|<0.0001
73821568|NCT03060291|147190049|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.549|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.549
73821569|NCT03060291|147190049|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.854|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.854
73821570|NCT03060291|147190049|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.469|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.469
73821571|NCT03060291|147190050|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.535|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.535
73821572|NCT03060291|147190050|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.081|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.081
73821573|NCT03060291|147190050|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.295|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.295
73821574|NCT03060291|147190051|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.149|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.149
73821575|NCT03060291|147190051|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.207|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.207
73821576|NCT03060291|147190051|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.871|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.871
73821577|NCT03060291|147190052|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.547|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.547
73821578|NCT03060291|147190052|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.575|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.575
73821579|NCT03060291|147190052|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.964|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.964
73821580|NCT03060291|147190053|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.236|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.236
73821581|NCT03060291|147190053|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.142|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.142
73821582|NCT03060291|147190053|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.81|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.810
73821583|NCT03060291|147190054|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.599|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.599
73821584|NCT03060291|147190054|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.523|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.523
73821585|NCT03060291|147190054|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.252|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.252
73821586|NCT03060291|147190055|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.867|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.867
73821587|NCT03060291|147190055|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.127|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.127
73821588|NCT03060291|147190055|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.101|TWO_SIDED||||||t-test, 2 sided||||Mean difference in slope with the web/mobile only as the reference group.|||.101
73821589|NCT01720524|147190056|SUPERIORITY||Least square (LS) mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.02||0.985|TWO_SIDED|95.0|-2.08|2.04|||ANCOVA|||||2.04|-2.08|0.9850
73821590|NCT01720524|147190057|SUPERIORITY||Difference in percentage|7.6||||0.4935|TWO_SIDED|95.0|-14.1|29.3|||Chi-squared|||||29.3|-14.1|0.4935
73821591|NCT01720524|147190058|SUPERIORITY|||||||0.9885|||||||Log Rank|||||||0.9885
73821592|NCT01720524|147190059|SUPERIORITY|||||||0.491|||||||Log Rank|||||||0.4910
73821593|NCT01720524|147190060|SUPERIORITY||Difference in Percentage|3.8||||0.7065|TWO_SIDED|95.0|-15.2|22.9|||Fisher Exact|||Additional Treatment||22.9|-15.2|0.7065
73821594|NCT01720524|147190060|SUPERIORITY||Difference in Percentage|0.3|||>|0.999|TWO_SIDED|95.0|-18.5|18.5|||Fisher Exact|||ECMO||18.5|-18.5|>0.999
73821595|NCT01720524|147190060|SUPERIORITY||Difference in Percentage|6.9||||0.2373|TWO_SIDED|95.0|-5.5|22.8|||Fisher Exact|||Death||22.8|-5.5|0.2373
73821596|NCT01720524|147190061|SUPERIORITY||LS Mean Difference|3.9||||0.4984|TWO_SIDED|95.0|-7.5|15.3|||ANCOVA|||Hour 6||15.3|-7.5|0.4984
73821597|NCT01720524|147190061|SUPERIORITY||LS Mean Difference|4.1||||0.3956|TWO_SIDED|95.0|-5.5|13.7|||ANCOVA|||Hour 12||13.7|-5.5|0.3956
73821598|NCT01720524|147190061|SUPERIORITY||LS Mean Difference|-2.2||||0.4249|TWO_SIDED|95.0|-7.6|3.3|||ANCOVA|||Hour 24||3.3|-7.6|0.4249
73821599|NCT01720524|147190062|SUPERIORITY||LS Mean Difference|0.7||||0.7686|TWO_SIDED|95.0|-4.3|5.8|||ANCOVA|||Hour 6||5.8|-4.3|0.7686
73821600|NCT01720524|147190062|SUPERIORITY||LS Mean Difference|-8.0||||0.1112|TWO_SIDED|95.0|-17.8|1.9|||ANCOVA|||Hour 12||1.9|-17.8|0.1112
73821601|NCT01720524|147190062|SUPERIORITY||LS Mean Difference|-8.2||||0.2089|TWO_SIDED|95.0|-21.2|4.8|||ANCOVA|||Hour 24||4.8|-21.2|0.2089
73821602|NCT01720524|147190063|SUPERIORITY||LS Mean Difference|37.2||||0.0829|TWO_SIDED|95.0|-5.0|79.5|||ANCOVA|||Hour 6||79.5|-5.0|0.0829
73821603|NCT01720524|147190063|SUPERIORITY||LS Mean Difference|26.6||||0.1802|TWO_SIDED|95.0|-12.7|65.9|||ANCOVA|||Hour 12||65.9|-12.7|0.1802
73821604|NCT01720524|147190063|SUPERIORITY||LS Mean Difference|79.9||||0.1576|TWO_SIDED|95.0|-32.5|192.2|||ANCOVA|||Hour 24||192.2|-32.5|0.1576
73821605|NCT02609984|147190123|OTHER||Hazard Ratio (HR)|0.8568||||0.49|TWO_SIDED|95.0|0.5507|1.333||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||1.3330|0.5507|0.4900
73821606|NCT02609984|147190124|OTHER||Hazard Ratio (HR)|1.2145||||0.4737|TWO_SIDED|95.0|0.7131|2.0684||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||2.0684|0.7131|0.4737
73821607|NCT02609984|147190128|OTHER|||||||0.3645||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank|||||||0.3645
73821608|NCT02609984|147190129|OTHER|||||||0.3466||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank|||||||0.3466
73821609|NCT02609984|147190130|OTHER||Hazard Ratio (HR)|0.7006||||0.1622|TWO_SIDED|95.0|0.4241|1.1574||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||1.1574|0.4241|0.1622
73821610|NCT02609984|147190131|OTHER||Hazard Ratio (HR)|1.1849||||0.6397|TWO_SIDED|95.0|0.5817|2.4134||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||2.4134|0.5817|0.6397
73821611|NCT02609984|147190132|OTHER|||||||0.1128|||||||exact Pearson chi-square test|||||||0.1128
73821612|NCT02609984|147190133|OTHER||||||<|0.0001|||||||exact Pearson chi-square test|||||||<0.0001
73821613|NCT02609984|147190134|OTHER|||||||0.405|||||||exact Pearson chi-square test|||||||0.4050
73821614|NCT02609984|147190135|OTHER|||||||0.0127|||||||exact Pearson chi-square test|||||||0.0127
73821615|NCT02504320|147190137|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0848|||||TWO_SIDED|90.0|0.9528|1.235|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.2350|0.9528|
73821616|NCT02504320|147190137|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.7709|||||TWO_SIDED|90.0|0.6767|0.8782|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.8782|0.6767|
73821617|NCT02504320|147190137|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9389|||||TWO_SIDED|90.0|0.8246|1.0689|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).||1.0689|0.8246|
73821618|NCT02504320|147190138|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0435|||||TWO_SIDED|90.0|0.984|1.1066|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.1066|0.9840|
73821619|NCT02504320|147190138|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.8777|||||TWO_SIDED|90.0|0.8274|0.9311|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.9311|0.8274|
73821620|NCT02504320|147190138|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.954|||||TWO_SIDED|90.0|0.8996|1.0117|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.0117|0.8996|
73821621|NCT02504320|147190139|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0283|||||TWO_SIDED|90.0|0.9691|1.0911|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.0911|0.9691|
73821622|NCT02504320|147190139|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9056|||||TWO_SIDED|90.0|0.8516|0.963|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.9630|0.8516|
73821623|NCT02504320|147190139|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimates|0.9463|||||TWO_SIDED|90.0|0.8909|1.0051|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).||1.0051|0.8909|
73821624|NCT03293394|147190145|SUPERIORITY||||||=|0.001|||||||ANCOVA|||||||=0.001
73821625|NCT03293394|147190146|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
73821626|NCT03293394|147190147|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.190
73821627|NCT03293394|147190148|SUPERIORITY|||||||0.652|||||||ANCOVA|||||||0.652
73821628|NCT03293394|147190149|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.190
73821629|NCT03293394|147190150|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
73821630|NCT03293394|147190151|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
73821631|NCT03293394|147190152|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
73821632|NCT00086450|147190153|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|7.9||||0.005||95.0|3.3|12.5|||Regression, Cox|||||12.5|3.3|0.005
73821633|NCT00086450|147190154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.74||||0.004||95.0|1.91|3.89|||Regression, Cox|||||3.89|1.91|0.004
73821634|NCT00086450|147190155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.4||||0.049||95.0|||||Log Rank|||||||0.049
73821635|NCT00086450|147190156|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Regression, Cox|||||||0.68
73821636|NCT00436826|147190180|SUPERIORITY||Relative Risk|0.37|||<|0.001|TWO_SIDED|95.0|0.22|0.63|||Wald Chi-square|||||0.63|0.22|<0.001
73821637|NCT04550364|147190213|OTHER|Semi-structured interview, background information, DSM 5 diagnosis and ED symptoms.||||||||||||||||23 of 24 women were used ideal type analysis as the methods. EDE-Q and DSM 5 diagnosis were measured.|Ideal type analysis as main method of analysis|||
73821638|NCT04550364|147190214|OTHER|Interpretative phenomenological analysis (IPA)||||||||||||||||of the 24 mothers there were 7 of them that had undergone In vitro fertilization. These women were interviewed twice and IPA were used in analysis the material.|IPA|||
73821639|NCT04550364|147190215|OTHER|Grounded theory was used analysis method. 5 distinct ED trajectories into motherhood were identified based on the womens experiences from pregnancy to postpartum.||||||||||||||||This study was based on interviews conducted with 24 participants during pregnancy and postpartum. Semi-structured interview with 24 women at two time points: 1. During pregnancy and 2. 4-6 months after birth. DSM 5 diagnosis at both time points were also assessed and symptoms at eating disorders through EDE-Q.|Qualitative methods using Ground theory|||
73821640|NCT02651337|147190235|OTHER|It is a one arm clinical study. No comparison between groups was made.|||||||||||||||||The study tested the hypothesis that the Alivio flusher could increase flow in occluded or sluggish flowing catheters. Analysis was made on the basis of the procedural results related to priming the flusher, connecting the flusher to the shunt, flushing the system by dome compression, the ability to refill the dome, and the ability to evacuate the dome.|||
73821641|NCT00869128|147190236|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANOVA|The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.||ANOVA, The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.||||0.04
73821642|NCT01603407|147190258|SUPERIORITY|||||||0.3904|||||||Mixed Models Analysis|||||||0.3904
73821643|NCT01603407|147190258|SUPERIORITY|||||||0.569|||||||Mixed Models Analysis|||||||0.5690
73821644|NCT01603407|147190258|SUPERIORITY|||||||0.1518|||||||Mixed Models Analysis|||||||0.1518
73821645|NCT01603407|147190259|SUPERIORITY|||||||0.7365|||||||Mixed Models Analysis|||||||0.7365
73821646|NCT01603407|147190259|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73821647|NCT01603407|147190259|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73821648|NCT01603407|147190260|SUPERIORITY|||||||0.2456|||||||Mixed Models Analysis|||||||0.2456
73821649|NCT01603407|147190260|SUPERIORITY|||||||0.0369|||||||Mixed Models Analysis|||||||0.0369
73821650|NCT01603407|147190260|SUPERIORITY|||||||0.3589|||||||Mixed Models Analysis|||||||0.3589
73821651|NCT01603407|147190261|SUPERIORITY|||||||0.7335|||||||Mixed Models Analysis|||||||0.7335
73821652|NCT01603407|147190261|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|||||||0.0004
73821653|NCT01603407|147190261|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
73821654|NCT01603407|147190262|SUPERIORITY|||||||0.9532|||||||Mixed Models Analysis|||||||0.9532
73821655|NCT01603407|147190262|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.0040
73821656|NCT01603407|147190262|SUPERIORITY|||||||0.0046|||||||Mixed Models Analysis|||||||0.0046
73821657|NCT01603407|147190263|SUPERIORITY|||||||0.332|||||||Mixed Models Analysis|||||||0.3320
73821658|NCT01603407|147190263|SUPERIORITY|||||||0.1248|||||||Mixed Models Analysis|||||||0.1248
73821659|NCT01603407|147190263|SUPERIORITY|||||||0.5854|||||||Mixed Models Analysis|||||||0.5854
73821660|NCT01603407|147190264|SUPERIORITY|||||||0.30814|||||||Mixed Models Analysis|||||||0.30814
73821661|NCT01603407|147190264|SUPERIORITY|||||||0.1405|||||||Mixed Models Analysis|||||||0.1405
73821662|NCT01603407|147190264|SUPERIORITY|||||||0.664|||||||Mixed Models Analysis|||||||0.6640
73821663|NCT01603407|147190266|SUPERIORITY|||||||0.8345|||||||Mixed Models Analysis|||||||0.8345
73821664|NCT01603407|147190266|SUPERIORITY|||||||0.3762|||||||Mixed Models Analysis|||||||0.3762
73821665|NCT01603407|147190266|SUPERIORITY|||||||0.5059|||||||Mixed Models Analysis|||||||0.5059
73821666|NCT01603407|147190267|SUPERIORITY|||||||0.5947|||||||Mixed Models Analysis|||||||0.5947
73821667|NCT01603407|147190267|SUPERIORITY|||||||0.1098|||||||Mixed Models Analysis|||||||0.1098
73821668|NCT01603407|147190267|SUPERIORITY|||||||0.2803|||||||Mixed Models Analysis|||||||0.2803
73821669|NCT01603407|147190268|SUPERIORITY|||||||0.3875|||||||Mixed Models Analysis|||||||0.3875
73821670|NCT01603407|147190268|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.4240
73821671|NCT01603407|147190268|SUPERIORITY|||||||0.9683|||||||Mixed Models Analysis|||||||0.9683
73821672|NCT01603407|147190269|SUPERIORITY|||||||0.6161|||||||Mixed Models Analysis|||||||0.6161
73821673|NCT01603407|147190269|SUPERIORITY|||||||0.7302|||||||Mixed Models Analysis|||||||0.7302
73821674|NCT01603407|147190269|SUPERIORITY|||||||0.9007|||||||Mixed Models Analysis|||||||0.9007
73821675|NCT01603407|147190270|SUPERIORITY|||||||0.8138|||||||Mixed Models Analysis|||||||0.8138
73821676|NCT01603407|147190270|SUPERIORITY|||||||0.5995|||||||Mixed Models Analysis|||||||0.5995
73821677|NCT01603407|147190270|SUPERIORITY|||||||0.7616|||||||Mixed Models Analysis|||||||0.7616
73821678|NCT01603407|147190271|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.6800
73821679|NCT01603407|147190271|SUPERIORITY|||||||0.4365|||||||Mixed Models Analysis|||||||0.4365
73821680|NCT01603407|147190271|SUPERIORITY|||||||0.7281|||||||Mixed Models Analysis|||||||0.7281
73821681|NCT01603407|147190272|SUPERIORITY||Mean Difference (Net)|-1.545||||0.0041|TWO_SIDED|98.3|-2.6611|-0.2479|||Mixed Models Analysis|||||-0.2479|-2.6611|0.0041
73821682|NCT01603407|147190272|SUPERIORITY||Mean Difference (Net)|0.9076||||0.9076|TWO_SIDED|98.3|-1.248|1.1331|||Mixed Models Analysis|||||1.1331|-1.248|0.9076
73821683|NCT01603407|147190272|SUPERIORITY||Mean Difference (Net)|1.3971||||0.0054|TWO_SIDED|98.3|0.2014|2.5927|||Mixed Models Analysis|||||2.5927|0.2014|0.0054
73821684|NCT01603407|147190273|SUPERIORITY||Mean Difference (Net)|-1.48|||<|0.0001|TWO_SIDED|98.3|-2.3242|-0.6358|||Mixed Models Analysis|||||-0.6358|-2.3242|<0.0001
73821685|NCT01603407|147190273|SUPERIORITY||Mean Difference (Net)|3.054|||<|0.0001|TWO_SIDED|98.3|2.2222|3.8857|||Mixed Models Analysis|||||3.8857|2.2222|<0.0001
73821686|NCT01603407|147190273|SUPERIORITY||Mean Difference (Net)|4.534|||<|0.0001|TWO_SIDED|98.3|3.6941|5.3738|||Mixed Models Analysis|||||5.3738|3.6941|<0.0001
73821687|NCT01603407|147190274|SUPERIORITY||Mean Difference (Net)|-0.6205||||0.0853|TWO_SIDED|98.3|-1.4845|0.2434|||Mixed Models Analysis|||||0.2434|-1.4845|0.0853
73821688|NCT01603407|147190274|SUPERIORITY||Mean Difference (Net)|-0.876||||0.0143|TWO_SIDED|98.3|-1.7292|-0.0229|||Mixed Models Analysis|||||-0.0229|-1.7292|0.0143
73821689|NCT01603407|147190274|SUPERIORITY||Mean Difference (Net)|-0.2555||||0.4731|TWO_SIDED|98.3|-1.1117|0.6007|||Mixed Models Analysis|||||0.6007|-1.1117|0.4731
73821690|NCT02500719|147190275|SUPERIORITY||Mean Difference (Net)|0.1319||||0.029|ONE_SIDED||||||t-test, 1 sided|||This test is to determine if the difference between engagement and disengagement of emotional arousal is increased by real-time neurofeedback guidance in PTSD participants.||||.029
73821691|NCT01990768|147190276|SUPERIORITY||Odds Ratio (OR)|0.87||||0.1809|ONE_SIDED|||||Based on an interim futility analysis, a one-sided P-value less than .1028 was required to declare benefit.|Regression, Logistic|Analysis was adjusted for regional site. Missing outcomes were multiply imputed.|Odds ratio for unfavorable GOS-E (\<=4) for the Combined TXA Arms (numerator) vs. Placebo (denominator)|This study was designed with an asymmetric boundary for tests for treatment harm and benefit. The conventional 0.025 level was used to test for harm while a 0.1 level was used to determine benefit for this Phase II trial. Statistical significance for the primary analysis was conducted under a group-sequential design that included a single, interim futility analysis using a Wang-Tsiatis boundary with parameter 0.8 based on outcome data from the first 200 subjects.||||.1809
73821692|NCT03538691|147190295|SUPERIORITY||Hazard Ratio (HR)|1.138||||0.51|TWO_SIDED|95.0|0.776|1.669|||Log Rank||The hazard ratio and 95% confidence interval (CI) were derived from the Cox proportional hazard model with treatment as fixed effect.|||1.669|0.776|0.5100
73821693|NCT03538691|147190296|SUPERIORITY||Least Squares (LS) Mean Difference|0.23||||0.2393|TWO_SIDED|95.0|-0.16|0.62||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||||0.62|-0.16|0.2393
73821694|NCT03538691|147190297|SUPERIORITY||Hazard Ratio (HR)|1.177||||0.3086|TWO_SIDED|95.0|0.857|1.615|||Log Rank||The hazard ratio and 95% CI were derived from the Cox proportional hazard model with treatment as fixed effect.|||1.615|0.857|0.3086
73821695|NCT03538691|147190298|SUPERIORITY|||||||0.603|||||||Chi-squared|||||||0.6030
73821696|NCT03538691|147190299|SUPERIORITY|||||||0.7081|||||||Chi-squared|||Week 21||||0.7081
73821697|NCT03538691|147190299|SUPERIORITY|||||||0.4589|||||||Chi-squared|||Week 23||||0.4589
73821698|NCT03538691|147190299|SUPERIORITY|||||||0.5314|||||||Chi-squared|||Week 25||||0.5314
73821699|NCT03538691|147190299|SUPERIORITY|||||||0.1433|||||||Chi-squared|||Week 29||||0.1433
73821700|NCT03538691|147190299|SUPERIORITY|||||||0.9636|||||||Chi-squared|||Week 33||||0.9636
73821701|NCT03538691|147190299|SUPERIORITY|||||||0.7596|||||||Chi-squared|||Week 37||||0.7596
73821702|NCT03538691|147190299|SUPERIORITY|||||||0.2402|||||||Chi-squared|||Week 41||||0.2402
73821703|NCT03538691|147190299|SUPERIORITY|||||||0.8363|||||||Chi-squared|||Week 45||||0.8363
73821704|NCT03538691|147190299|SUPERIORITY|||||||0.8308|||||||Chi-squared|||Week 46||||0.8308
73821705|NCT03538691|147190300|SUPERIORITY||LS Mean Difference|-0.12||||0.8806|TWO_SIDED|95.0|-1.73|1.49|||ANCOVA|P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.||||1.49|-1.73|0.8806
73821706|NCT03538691|147190301|SUPERIORITY||LS Mean Difference|0.03||||0.7956|TWO_SIDED|95.0|-0.18|0.24|||ANCOVA|P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.||||0.24|-0.18|0.7956
73821707|NCT03538691|147190302|SUPERIORITY||LS Mean Difference|0.15||||0.5223|TWO_SIDED|95.0|-0.31|0.61||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Work/School||0.61|-0.31|0.5223
73821708|NCT03538691|147190302|SUPERIORITY||LS Mean Difference|0.36||||0.0904|TWO_SIDED|95.0|-0.06|0.77||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Social Life||0.77|-0.06|0.0904
73821709|NCT03538691|147190302|SUPERIORITY||LS Mean Difference|0.25||||0.2289|TWO_SIDED|95.0|-0.16|0.67||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Family Life||0.67|-0.16|0.2289
73821710|NCT06597084|147190307|OTHER||Percentiles of time to first US|92.0||||0.2081|TWO_SIDED|95.0|25.0|95.0|||Log Rank|||||95|25|0.2081
73821711|NCT06597084|147190313|OTHER||Overall Survival|||||0.0542|||||||Log Rank|||||||0.0542
73821712|NCT03479944|147190323|SUPERIORITY||Least Squares Mean Difference|-1.505|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.289|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures|||-1.289|-1.720|<0.0001
73821713|NCT03479944|147190324|SUPERIORITY||Least Squares Mean Difference|1.2||||0.2602|TWO_SIDED|95.0|-0.9|3.3|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures|||3.3|-0.9|0.2602
73821714|NCT03479944|147190325|SUPERIORITY||Least Squares Mean Difference|-11.52|||||TWO_SIDED|95.0|-15.87|-7.18|||||Least Squares Mean Difference from a Mixed Model for Repeated Measures|||-7.18|-15.87|
73821715|NCT02029274|147190328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.551|STANDARD_ERROR_OF_MEAN|11.5519||0.9621|TWO_SIDED|95.0|-22.447|23.549|||Repeated measures analysis|||||23.549|-22.447|0.9621
73821716|NCT02029274|147190328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.368|STANDARD_ERROR_OF_MEAN|10.9297||0.1637|TWO_SIDED|95.0|-37.128|6.391|||Repeated measures analysis|||||6.391|-37.128|0.1637
73821717|NCT02029274|147190328|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.709|STANDARD_ERROR_OF_MEAN|11.6016||0.2409|TWO_SIDED|95.0|-36.806|9.388|||Repeated measures|||||9.388|-36.806|0.2409
73821718|NCT03272347|147190340|OTHER|The 95% confidence intervals (CIs) were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|2.9|||||TWO_SIDED|95.0|-12.5|18.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||18.3|-12.5|
73821719|NCT03272347|147190340|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|9.6|||||TWO_SIDED|95.0|-3.8|23.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||23.0|-3.8|
73821720|NCT03272347|147190340|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|0.2|||||TWO_SIDED|95.0|-16.0|16.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||16.3|-16.0|
73821721|NCT03272347|147190341|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|6.1|||||TWO_SIDED|95.0|-12.2|24.4|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||24.4|-12.2|
73821722|NCT03272347|147190341|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|6.2|||||TWO_SIDED|95.0|-12.2|24.6|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||24.6|-12.2|
73821723|NCT03272347|147190341|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-6.1|||||TWO_SIDED|95.0|-27.1|14.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||14.8|-27.1|
73821724|NCT03272347|147190342|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|2.6|||||TWO_SIDED|95.0|-15.7|20.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.5|-15.7|
73821725|NCT03272347|147190342|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|2.9|||||TWO_SIDED|95.0|-15.0|20.8|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.8|-15.0|
73821726|NCT03272347|147190342|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-9.7|||||TWO_SIDED|95.0|-29.4|10.1|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||10.1|-29.4|
73821727|NCT03272347|147190343|OTHER|Based on Miettinen \& Nurminen method|Difference in %|0.2|||||TWO_SIDED|95.0|-13.4|14.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||14.5|-13.4|
73821728|NCT03272347|147190343|OTHER|Based on Miettinen \& Nurminen method|Difference in %|-3.2|||||TWO_SIDED|95.0|-16.4|8.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.5|-16.4|
73821729|NCT03272347|147190343|OTHER|Based on Miettinen \& Nurminen method|Difference in %|3.2|||||TWO_SIDED|95.0|-10.8|18.1|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||18.1|-10.8|
73821730|NCT03272347|147190344|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-9.7|||||TWO_SIDED|95.0|-26.1|6.6|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||6.6|-26.1|
73821731|NCT03272347|147190344|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-6.2|||||TWO_SIDED|95.0|-21.5|9.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||9.1|-21.5|
73821732|NCT03272347|147190344|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-7.5|||||TWO_SIDED|95.0|-23.9|8.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||8.8|-23.9|
73821733|NCT03272347|147190345|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|2.2|||||TWO_SIDED|95.0|-23.4|27.7|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||27.7|-23.4|
73821734|NCT03272347|147190345|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-3.7|||||TWO_SIDED|95.0|-29.6|22.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||22.1|-29.6|
73821735|NCT03272347|147190345|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-1.3|||||TWO_SIDED|95.0|-27.7|25.2|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||25.2|-27.7|
73821736|NCT03272347|147190347|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|78.4|||||TWO_SIDED|95.0|18.8|138.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||138.1|18.8|
73821737|NCT03272347|147190347|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|50.7|||||TWO_SIDED|95.0|-31.7|133.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||133.1|-31.7|
73821738|NCT03272347|147190347|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|0.8|||||TWO_SIDED|95.0|-63.0|64.7|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||64.7|-63.0|
73821739|NCT03272347|147190348|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|0.6|||||TWO_SIDED|95.0|-74.1|75.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||75.3|-74.1|
73821740|NCT03272347|147190348|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|1.5|||||TWO_SIDED|95.0|-70.7|73.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||73.8|-70.7|
73821741|NCT03272347|147190348|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-80.8|||||TWO_SIDED|95.0|-165.6|4.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||4.0|-165.6|
73821742|NCT03272347|147190349|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-25.5|||||TWO_SIDED|95.0|-134.8|83.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||83.8|-134.8|
73821743|NCT03272347|147190349|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-107.6|||||TWO_SIDED|95.0|-212.1|-3.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||-3.1|-212.1|
73821744|NCT03272347|147190349|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-132.4|||||TWO_SIDED|95.0|-242.9|-21.9|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||-21.9|-242.9|
73821745|NCT03272347|147190350|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-65.6|||||TWO_SIDED|95.0|-195.3|64.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||64.0|-195.3|
73821746|NCT03272347|147190350|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-61.0|||||TWO_SIDED|95.0|-188.7|66.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||66.8|-188.7|
73821747|NCT03272347|147190350|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-107.1|||||TWO_SIDED|95.0|-231.2|16.9|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||16.9|-231.2|
73821748|NCT03272347|147190352|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|4.9|||||TWO_SIDED|95.0|-20.3|29.6|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||29.6|-20.3|
73821749|NCT03272347|147190352|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|9.5|||||TWO_SIDED|95.0|-15.4|33.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||33.5|-15.4|
73821750|NCT03272347|147190352|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-5.3|||||TWO_SIDED|95.0|-30.6|20.7|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.7|-30.6|
73821751|NCT03272347|147190353|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-3.6|||||TWO_SIDED|95.0|-17.9|8.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.5|-17.9|
73821752|NCT03272347|147190353|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-3.6|||||TWO_SIDED|95.0|-17.9|8.2|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.2|-17.9|
73821753|NCT03272347|147190353|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|3.8|||||TWO_SIDED|95.0|-11.5|20.6|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.6|-11.5|
73821754|NCT02603211|147190404|OTHER||||||||||||||||||"We will obtain 20 tactile image data sets from the breast tumor patients. The tactile images will be converted to size and deformation index. Then these two parameters will be converted to the risk score. This is a small number of patients for statistically significance study. Therefore, we plan to use the Leave-One-Out-Cross-Validation (LOOCV) technique to validate the human test results to determine the performance of the device.~We obtain the Risk Score. Risk Score is a unit less numerical value, which can be used as a scale to classify the tumor as malignant and benign. Based on the calculated size of the tumor and measured deformation index, the breast tumors are classified as benign and malignant using scoring method. The risk score will range from 0 to 5, where 0 represents the benign and 5 represents the malignant tumor.~Comparing the Risk Score and the Pathology reports we obtain sensitivity, specificity and accuracy of the system."|||
73821755|NCT03397121|147190412|SUPERIORITY||Mean Difference (Final Values)|-49.52|||<|0.0001|TWO_SIDED|95.0|-55.04|-43.99||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-43.99|-55.04|<.0001
73821756|NCT03397121|147190413|SUPERIORITY||Mean Difference (Final Values)|-44.3|||<|0.0001|TWO_SIDED|95.0|-48.48|-40.12||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-40.12|-48.48|<0.0001
73821757|NCT03397121|147190414|SUPERIORITY||Mean Difference (Final Values)|-68.89|||<|0.0001|TWO_SIDED|95.0|-77.11|-60.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-60.67|-77.11|<0.0001
73821758|NCT03397121|147190415|SUPERIORITY||Mean Difference (Final Values)|-62.74|||<|0.0001|TWO_SIDED|95.0|-69.01|-56.48||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-56.48|-69.01|<0.0001
73821759|NCT03397121|147190416|SUPERIORITY||Mean Difference (Final Values)|-78.34|||<|0.0001|TWO_SIDED|95.0|-83.65|-73.04||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-73.04|-83.65|<0.0001
73821760|NCT03397121|147190417|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-31.77|||<|0.0001|TWO_SIDED|95.0|-35.59|-27.94||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-27.94|-35.59|<0.0001
73821761|NCT03397121|147190418|SUPERIORITY||Mean Difference (Final Values)|-36.06|||<|0.0001|TWO_SIDED|95.0|-39.99|-32.14||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-32.14|-39.99|<0.0001
73821762|NCT03397121|147190419|SUPERIORITY||Mean Difference (Final Values)|-42.36|||<|0.0001|TWO_SIDED|95.0|-47.32|-37.4||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-37.40|-47.32|<0.0001
73821763|NCT04085601|147190422|SUPERIORITY||Difference|0.7311|||<|0.0001|TWO_SIDED|95.0|0.572|0.8902||Cochran-Mantel-Haenszel test is stratified by number of packed red blood cell (PRBC) within 12 months prior to screening (\<4, ≥ 4) reported in electronic data capture (EDC) data.|Cochran-Mantel-Haenszel|||||0.8902|0.572|<0.0001
73821764|NCT04085601|147190423|SUPERIORITY||LS mean difference|-1470.38|||<|0.0001|TWO_SIDED|95.0|-2113.44|-827.32||p-value for Baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||-827.32|-2113.44|<0.0001
73821765|NCT04085601|147190424|SUPERIORITY||Difference|0.5411|||<|0.0001|TWO_SIDED|95.0|0.339|0.7431||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥ 4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.7431|0.339|<0.0001
73821766|NCT04085601|147190425|SUPERIORITY||LS mean difference|-103.82||||0.0002|TWO_SIDED|95.0|-158.9|-48.74||P-value for Baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||-48.74|-158.9|0.0002
73821767|NCT04085601|147190426|SUPERIORITY||LS mean difference|2.67||||0.0019|TWO_SIDED|95.0|0.99|4.35||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||4.35|0.99|0.0019
73821768|NCT04085601|147190427|SUPERIORITY||Difference|-0.7505|||<|0.0001|TWO_SIDED|95.0|-0.9041|-0.5969||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥4) reported in EDC data.|Cochran-Mantel-Haenszel|||||-0.5969|-0.9041|<0.0001
73821769|NCT04085601|147190428|SUPERIORITY||Difference|0.7241|||<|0.0001|TWO_SIDED|95.0|0.5583|0.8899||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.8899|0.5583|<0.0001
73821770|NCT04085601|147190429|SUPERIORITY||Median Difference (Net)|3.0|||<|0.0001|TWO_SIDED|95.0|2.0|4.0||Wilcoxon rank-sum test p-value for the comparison between treatments is based on median using stratified non-parametric analysis. The 95% confidence interval (CI) is constructed using Hodges-Lehmann Estimation of Location Shift.|Wilcoxon Rank-Sum Test|||||4|2|<0.0001
73821771|NCT04085601|147190430|SUPERIORITY||LS mean difference|4.51||||0.061|TWO_SIDED|95.0|-0.21|9.24||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||9.24|-0.21|0.061
73821772|NCT04085601|147190431|SUPERIORITY||Difference|0.3645||||0.001|TWO_SIDED|95.0|0.1648|0.5642|||Cochran-Mantel-Haenszel|||||0.5642|0.1648|0.001
73821773|NCT04085601|147190432|SUPERIORITY||Difference|0.5592|||<|0.0001|TWO_SIDED|95.0|0.3682|0.7502|||Cochran-Mantel-Haenszel|||||0.7502|0.3682|<0.0001
73821774|NCT04085601|147190433|SUPERIORITY||LS mean difference|21.75||||0.0006|TWO_SIDED|95.0|9.35|34.16||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||34.16|9.35|0.0006
73821775|NCT04085601|147190434|SUPERIORITY||LS mean difference|55.79||||0.005|TWO_SIDED|95.0|16.83|94.74||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||94.74|16.83|0.005
73821776|NCT04085601|147190435|SUPERIORITY||Difference|0.4639||||0.0002|TWO_SIDED|95.0|0.2529|0.675||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥ 4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.675|0.2529|0.0002
73821777|NCT04085601|147190436|SUPERIORITY||Stratified Hazard Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.004|0.091||Hazard ratio is based on cox proportional hazards model.|Stratified Wilcoxon|||||0.091|0.004|<0.0001
73821778|NCT04085601|147190437|SUPERIORITY||Stratified Hazard Ratio|0.025|||<|0.0001|TWO_SIDED|95.0|0.005|0.121|||Stratified Wilcoxon|||||0.121|0.005|<0.0001
73821779|NCT03492437|147190438|OTHER||Ratio of Geometric Least square Mean|151.38|||||TWO_SIDED|90.0|127.35|179.93||||||||179.93|127.35|
73821780|NCT03492437|147190439|OTHER||Ratio of Geometric Least square Mean|144.7|||||TWO_SIDED|90.0|122.89|170.39||||||||170.39|122.89|
73821781|NCT03492437|147190440|OTHER||Ratio of Geometric Least square Mean|138.45|||||TWO_SIDED|90.0|121.59|157.65||||||||157.65|121.59|
73821782|NCT03492437|147190441|OTHER||Median Difference (Net)|0.5|||||TWO_SIDED|90.0|-0.3|1.0||||||||1.0|-0.3|
73821783|NCT02418234|147190452|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
73821784|NCT02418234|147190453|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73821785|NCT02915159|147190454|SUPERIORITY|||||||0.4421|||||||longitudinal repeated measures analysis|||||||0.4421
73821786|NCT02915159|147190455|SUPERIORITY|||||||0.3367|||||||longitudinal repeated measures analysis|||||||0.3367
73821787|NCT02915159|147190456|SUPERIORITY|||||||0.5841|||||||longitudinal repeated measures analysis|||||||.5841
73821788|NCT04534517|147190495|SUPERIORITY|The superiority of the Test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 32 points|Mean Estimate|58.6|STANDARD_DEVIATION|3.26|||TWO_SIDED|95.0|52.3|64.9|||Bayesian multivariate random-effects||Included Hyperope group only|It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||64.9|52.3|
73821789|NCT04534517|147190495|SUPERIORITY|The superiority of the Test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 40 points for Myopes|Mean Estimate|63.8|STANDARD_DEVIATION|2.97|||TWO_SIDED|95.0|57.9|69.6|||Bayesian multivariate random-effects||Included myope group only.|It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||69.6|57.9|
73821790|NCT04534517|147190496|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.10 logMAR for Distance|Mean estimate|-0.09|STANDARD_DEVIATION|0.0172|||TWO_SIDED|95.0|-0.125|-0.057|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||-0.057|-0.125|
73821791|NCT04534517|147190496|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Intermediate|Mean Estimate|-0.057|STANDARD_DEVIATION|0.0171|||TWO_SIDED|95.0|-0.091|-0.024|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||-0.024|-0.091|
73821792|NCT04534517|147190496|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Near|Mean Estimate|0.066|STANDARD_DEVIATION|0.0171|||TWO_SIDED|95.0|0.031|0.098|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||0.098|0.031|
73821793|NCT04534517|147190497|SUPERIORITY|A superiority margin of 5% was used. Upper limit of 95% credible interval was compared to 5%.|Mean Proportion|0.001|STANDARD_DEVIATION|0.0012|||TWO_SIDED|95.0|0.0|0.004|||Bayesian beta-binomial model|Correlated Binary Data||||0.004|0.000|
73821794|NCT04534517|147190498|SUPERIORITY|A superiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Proportion|0.005|STANDARD_DEVIATION|0.0048|||TWO_SIDED|95.0|0.0|0.018|||Bayesian beta-binomial model|Correlated Binary Data||||0.018|0.000|
73821795|NCT04534517|147190499|SUPERIORITY|A superiority margin of 90% was used. Lower limit of the 95% credible interval was compared to 90%|Mean Proportion|0.992|STANDARD_DEVIATION|0.0072|||TWO_SIDED|95.0|0.973|0.999|||Bayesian beta-binomial model|Correlated Binary Data||||0.999|0.973|
73821796|NCT00823264|147190503|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
73821797|NCT05133323|147190504|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.89||0.0106|ONE_SIDED|90.0||-0.6|||ANCOVA|||||-0.6||0.0106
73821798|NCT00113295|147190508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.05||||||No adjustment for multiple testing|t-test, 2 sided||This analysis applies to the additional reduction from phase 2 randomization to phase 2 endpoint in HAM-A scores.|In phase 2, comprising randomized double-blind quetiapine augmentation, change scores were examined with two-tailed, two-sample t tests, utilizing scores at phase 2 randomization as baseline. All analyses were intention to treat (ITT) with the last visit carried forward (LVCF) for subjects that did not complete the study.||||<0.05
73821799|NCT02363387|147190548|SUPERIORITY||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|2.7|18.8|||Regression, Logistic|||||18.8|2.7|<0.001
73821800|NCT02609386|147190555|OTHER||Cox Proportional Hazard|1.102||||0.6176|TWO_SIDED|95.0|0.6|2.1|||Log Rank|||||2.1|0.6|0.6176
73821801|NCT02609386|147190556|OTHER||Cox Proportional Hazard|1.009||||0.3889|TWO_SIDED|95.0|0.5|2.2|||Log Rank|||||2.2|0.5|0.3889
73821802|NCT02609386|147190557|OTHER||Cox Proportional Hazard|1.009||||0.5091|TWO_SIDED|95.0|0.5|2.2|||Log Rank|||||2.2|0.5|0.5091
73821803|NCT01065571|147190558|EQUIVALENCE|Non-parametric analysis of interval to relapse||||||0.046||||||result from log rank test|Log Rank|||Kaplan-Meier life table analysis was performed to compare the two groups. The null hypothesis was that there would be no difference in relapses between the two groups during the study.||||0.046
73821804|NCT01065571|147190559|SUPERIORITY|fecal calprotectin (micrograms/gm stool)||||||0.06|||||||t-test, 2 sided|||||||0.06
73821805|NCT01065571|147190560|SUPERIORITY|||||||0.02||||||not adjusted for muliple comparisons, a priori threshold of 0.05|t-test, 2 sided|||paired t-test comparing baseline and value at end of participation||||0.02
73821806|NCT01001520|147190572|SUPERIORITY_OR_OTHER|||||||0.88||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the right dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.88
73821807|NCT01001520|147190573|SUPERIORITY_OR_OTHER|||||||0.017||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Accuracy was examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would increase subject's accuracy during the N-back working memory task.||||0.017
73821808|NCT01001520|147190574|SUPERIORITY_OR_OTHER|||||||0.88||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would reduce subject's reaction time during the N-back working memory task.||||0.88
73821809|NCT01001520|147190575|SUPERIORITY_OR_OTHER|||||||0.85||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers would smoke fewer cigarettes while taking tolcapone (vs. placebo).||||0.85
73821810|NCT01001520|147190576|SUPERIORITY_OR_OTHER|||||||0.4||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience less cigarette craving during their 24-hour abstinence period.||||0.40
73821811|NCT01001520|147190577|SUPERIORITY_OR_OTHER|||||||0.43||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience fewer withdrawal symptoms during their 24-hour abstinence period.||||0.43
73821812|NCT01001520|147190578|SUPERIORITY_OR_OTHER|||||||0.18||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the left dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.18
73821813|NCT01001520|147190579|SUPERIORITY_OR_OTHER|||||||0.67||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the dorsal cingulate/medial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.67
73821814|NCT01001520|147190580|SUPERIORITY_OR_OTHER|||||||0.98||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the posterior cingulate cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.98
73821815|NCT01001520|147190581|SUPERIORITY_OR_OTHER|||||||0.002||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the ventromedial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.002
73821816|NCT02541422|147190582|SUPERIORITY|||||||0.45||||||p-value calculated for the total hangover scale|Wilcoxon (Mann-Whitney)|||||||0.45
73821817|NCT02541422|147190582|SUPERIORITY|||||||0.93||||||p value calculated for symptom of headache|Wilcoxon (Mann-Whitney)|||||||0.93
73821818|NCT02541422|147190582|SUPERIORITY|||||||0.11||||||p value calculated for symptom of nausea|Wilcoxon (Mann-Whitney)|||||||0.11
73821819|NCT02541422|147190582|SUPERIORITY|||||||0.72||||||p value calculated for symptom of weakness|Wilcoxon (Mann-Whitney)|||||||0.72
73821820|NCT02820870|147190592|SUPERIORITY||Odds Ratio (OR)|3.0|||<|0.01|TWO_SIDED|95.0|1.84|4.9|||Regression, Logistic|With clustering by provider and team.||||4.9|1.84|<0.01
73821821|NCT02820870|147190593|SUPERIORITY||Odds Ratio (OR)|1.65||||0.06|TWO_SIDED|95.0|0.99|2.77|||Regression, Logistic|With cluster by provider and team.||||2.77|0.99|0.06
73821822|NCT02754518|147190601|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
73821823|NCT02754518|147190602|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
73821824|NCT02754518|147190603|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
73821825|NCT02754518|147190604|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
73821826|NCT02754518|147190605|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
73821827|NCT02754518|147190606|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
73821828|NCT02754518|147190607|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
73821829|NCT02754518|147190608|OTHER|||||||0.13||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.|paired t-test|||0.13
73821830|NCT02754518|147190609|OTHER|||||||0.95||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.95
73821831|NCT02754518|147190610|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
73821832|NCT02754518|147190611|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
73821833|NCT02754518|147190612|OTHER|||||||0.65||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired T-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.65
73821834|NCT02754518|147190613|OTHER|||||||0.06||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.06
73821835|NCT02754518|147190614|OTHER|||||||0.76||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.76
73821836|NCT02754518|147190615|OTHER|||||||0.07||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Fisher Exact|||Primary outcome was presented at baseline and 1-year as frequency and percentages based upon the Shapiro-Wilks test of normality, and then analyzed with the Fisher exact test.||||0.07
73821837|NCT02754518|147190616|OTHER|||||||0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.001
73821838|NCT02754518|147190619|OTHER|||||||0.03||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.03
73821839|NCT02754518|147190620|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
73821840|NCT02754518|147190621|OTHER|||||||0.02||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.02
73821841|NCT02754518|147190622|OTHER||||||<|0.001||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
73821842|NCT02754518|147190623|OTHER|||||||0.82||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.82
73821843|NCT02754518|147190624|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
73821844|NCT02754518|147190625|OTHER|||||||0.01||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.01
73821845|NCT02754518|147190626|OTHER|||||||0.11||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.11
73821846|NCT02754518|147190627|OTHER|||||||0.17||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.17
73821847|NCT02754518|147190628|OTHER|||||||0.035||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.035
73821848|NCT02754518|147190629|OTHER|||||||0.059||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.059
73821849|NCT02754518|147190630|OTHER|||||||0.054||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.054
73821850|NCT02754518|147190631|OTHER|||||||0.28||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.28
73821851|NCT02754518|147190632|OTHER|||||||0.002||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.002
73821852|NCT02754518|147190633|OTHER|||||||0.008||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.008
73821853|NCT02754518|147190634|OTHER|||||||0.005||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.005
73821854|NCT02754518|147190635|OTHER|||||||0.056||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.056
73821855|NCT03318003|147190648|SUPERIORITY||Pearson Chi Square|0.76||||0.92|TWO_SIDED|||||no adjustments made|Chi-squared|||||||0.92
73821856|NCT01468454|147190652|OTHER||Specificity|89.5|||||TWO_SIDED|95.0|75.2|97.1||||||||97.1|75.2|
73821857|NCT01468454|147190652|OTHER||Sensitivity|83.9|||||TWO_SIDED|95.0|72.3|92.0||||||||92|72.3|
73821858|NCT02028507|147190689|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.003|TWO_SIDED|95.0|0.55|0.89|||Regression, Cox|||This statistical Analysis corresponds to Global health status/quality of life scale||0.89|0.55|0.003
73821859|NCT02028507|147190689|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.5|0.76|||Regression, Cox|||This statistical Analysis corresponds to Physical functioning scale||0.76|0.50|<0.001
73821860|NCT02028507|147190689|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.51|0.79|||Regression, Cox|||This statistical Analysis corresponds to Role functioning scale||0.79|0.51|<0.001
73821861|NCT02028507|147190689|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.818|TWO_SIDED|95.0|0.76|1.25|||Regression, Cox|||This statistical Analysis corresponds to Emotional functioning scale||1.25|0.76|0.818
73821862|NCT02028507|147190689|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.004|TWO_SIDED|95.0|0.54|0.89|||Regression, Cox|||This statistical Analysis corresponds to Cognitive functioning scale||0.89|0.54|0.004
73821863|NCT02028507|147190689|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.49|0.78|||Regression, Cox|||This Statistical Analysis corresponds to Social functioning scale||0.78|0.49|<0.001
73821864|NCT02028507|147190690|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.001|TWO_SIDED|95.0|0.57|0.86|||Regression, Cox|||This Statistical Analysis corresponds to Fatigue scale||0.86|0.57|0.001
73821865|NCT02028507|147190690|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.76|||Regression, Cox|||This Statistical Analysis corresponds to Nausea and vomiting scale||0.76|0.45|<0.001
73821866|NCT02028507|147190690|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.042|TWO_SIDED|95.0|0.62|0.99|||Regression, Cox|||This Statistical Analysis corresponds to Pain scale||0.99|0.62|0.042
73821867|NCT02028507|147190690|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.599|TWO_SIDED|95.0|0.81|1.44|||Regression, Cox|||This Statistical Analysis corresponds to Dyspnea scale||1.44|0.81|0.599
73821868|NCT02028507|147190690|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.196|TWO_SIDED|95.0|0.64|1.1|||Regression, Cox|||This Statistical Analysis corresponds to Insomnia scale||1.10|0.64|0.196
73821869|NCT02028507|147190690|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.011|TWO_SIDED|95.0|0.54|0.92|||Regression, Cox|||This Statistical Analysis corresponds to Appetite loss scale||0.92|0.54|0.011
73821870|NCT02028507|147190690|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.564|TWO_SIDED|95.0|0.83|1.41|||Regression, Cox|||This Statistical Analysis corresponds to Constipation scale||1.41|0.83|0.564
73821871|NCT02028507|147190690|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.32|0.55|||Regression, Cox|||This Statistical Analysis corresponds to Diarrhea scale||0.55|0.32|<0.001
73821872|NCT02028507|147190690|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.118|TWO_SIDED|95.0|0.56|1.07|||Regression, Cox|||This Statistical Analysis corresponds to Financial difficulties scale||1.07|0.56|0.118
73821873|NCT02028507|147190691|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.659|TWO_SIDED|95.0|0.74|1.21|||Regression, Cox|||This Statistical Analysis corresponds to Body image scale||1.21|0.74|0.659
73821874|NCT02028507|147190691|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.74|1.39|||Regression, Cox|||This Statistical Analysis corresponds to Future perspective scale||1.39|0.74|0.928
73821875|NCT02028507|147190692|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.029|TWO_SIDED|95.0|0.64|0.98|||Regression, Cox|||This Statistical Analysis corresponds to Systemic side-effects scale||0.98|0.64|0.029
73821876|NCT02028507|147190692|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.571|TWO_SIDED|95.0|0.71|1.21|||Regression, Cox|||This Statistical Analysis corresponds to Breast symptoms scale||1.21|0.71|0.571
73821877|NCT02028507|147190692|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.187|TWO_SIDED|95.0|0.66|1.09|||Regression, Cox|||This Statistical Analysis corresponds to Arm symptoms scale||1.09|0.66|0.187
73821878|NCT00718094|147190713|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
73821879|NCT00705341|147190720|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Regression, Linear|||Log-linear generalized estimating equation (GEE) models were used to assess the dose effect on PC20.||||0.65
73821880|NCT00527826|147190746|NON_INFERIORITY_OR_EQUIVALENCE|Negative binomial model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.73||95.0|||||Negative binomial model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.||||||0.73
73821881|NCT00527826|147190748|NON_INFERIORITY_OR_EQUIVALENCE|Poisson model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.66||95.0|||||Poisson model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.||||||0.66
73821882|NCT01808261|147190761|OTHER||Mean Difference (Net)|0.0443|STANDARD_ERROR_OF_MEAN|0.0809||0.713||95.0|-0.119|0.2||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg - placebo) is greater than 0 m/s at Month 3/Day 90.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.||0.2|-0.119|0.713
73821883|NCT01808261|147190762|OTHER||Mean Difference (Net)|0.0794|STANDARD_ERROR_OF_MEAN|0.0857||0.828|TWO_SIDED|95.0|-0.093|0.247||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg - placebo) is greater than 0 m/s at Month 6/Day 180.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.||0.247|-0.093|0.828
73821884|NCT01808261|147190764|OTHER||Mean Difference (Net)|2.408|STANDARD_ERROR_OF_MEAN|2.7495|||TWO_SIDED|95.0|-3.067|7.883||||||Statistical data for Day 30. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||7.883|-3.067|
73821885|NCT01808261|147190764|OTHER||Mean Difference (Net)|3.015|STANDARD_ERROR_OF_MEAN|2.8732|||TWO_SIDED|95.0|-2.704|8.735||||||Statistical data for Day 60. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||8.735|-2.704|
73821886|NCT01808261|147190764|OTHER||Mean Difference (Net)|2.435|STANDARD_ERROR_OF_MEAN|3.5633|||TWO_SIDED|95.0|-4.668|9.538||||||Statistical data for Day 90. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||9.538|-4.668|
73821887|NCT01808261|147190764|OTHER||Mean Difference (Net)|3.944|STANDARD_ERROR_OF_MEAN|3.5635|||TWO_SIDED|95.0|-3.15|11.037||||||Statistical data for Day 180. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||11.037|-3.15|
73821888|NCT02497404|147190797|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|46.2|||||TWO_SIDED|95.0|30.1|62.8||||||||62.8|30.1|
73821889|NCT02497404|147190798|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|64.1|||||TWO_SIDED|95.0|47.2|78.8||||||||78.8|47.2|
73821890|NCT02497404|147190799|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|33.3|||||TWO_SIDED|95.0|19.1|50.2||||||||50.2|19.1|
73821891|NCT02497404|147190800|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|89.7|||||TWO_SIDED|95.0|75.8|97.1||||||||97.1|75.8|
73821892|NCT02497404|147190801|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|64.1|||||TWO_SIDED|95.0|47.2|78.8||||||||78.8|47.2|
73821893|NCT02497404|147190802|OTHER||Proportion (percent)|38.5|||||TWO_SIDED|95.0|23.4|55.4||||||Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.||55.4|23.4|
73821894|NCT02497404|147190803|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the graft failure proportion.|Proportion (percent)|2.6|||||TWO_SIDED|95.0|0.07|13.5||||||||13.5|0.07|
73821895|NCT02497404|147190804|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the GVHD proportion.|Proportion (percent)|33.3|||||TWO_SIDED|95.0|19.1|50.2||||||||50.2|19.1|
73821896|NCT02497404|147190805|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the high-risk extensive chronic graft-versus-host-disease proportion.|Proportion (percent)|5.1|||||TWO_SIDED|95.0|0.63|15.3||||||||15.3|0.63|
73821897|NCT05568797|147190816|NON_INFERIORITY|The non-inferiority is demonstrated if the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is less than or equal (\<=) 1.5.|GMT Ratio|1.32|||||TWO_SIDED|0.95|1.13|1.53|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Darwin/6/2021 H3N2 strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.53|1.13|
73896531|NCT03456882|147326402|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.22||0.2209|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.2209
73821898|NCT05568797|147190816|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|1.04|||||TWO_SIDED|0.95|0.91|1.18|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.18|0.91|
73821899|NCT05568797|147190816|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.97|||||TWO_SIDED|0.95|0.9|1.06|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.06|0.90|
73821900|NCT05568797|147190816|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|1.04|||||TWO_SIDED|0.95|0.95|1.13|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the Flu vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.13|0.95|
73821901|NCT05568797|147190817|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-A neutralizing antibody vaccine is \<=1.5.|GMT Ratio|0.99|||||TWO_SIDED|0.95|0.87|1.12|||||The comparison is done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-A neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.12|0.87|
73821902|NCT05568797|147190818|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-B neutralizing antibody vaccine is \<=1.5.|GMT Ratio|1.16|||||TWO_SIDED|0.95|1.03|1.3|||||The comparison is done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-B neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the CoAd Group and Day 61 for the Control Group).||1.30|1.03|
73821903|NCT05568797|147190819|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|10.25|||||TWO_SIDED|0.95|3.5|16.9||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Darwin/6/2021 H3N2 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||16.90|3.50|
73821904|NCT05568797|147190819|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|1.66|||||TWO_SIDED|0.95|-5.16|8.47||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Victoria/2570/2019 H1N1 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||8.47|-5.16|
73821905|NCT05568797|147190819|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|0.25|||||TWO_SIDED|0.95|-4.92|5.46||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Austria/1359417/2021 Victoria at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||5.46|-4.92|
73821906|NCT05568797|147190819|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|0.79|||||TWO_SIDED|0.95|-4.54|6.17||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Phuket/3073/2013 Yamagata strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||6.17|-4.54|
73821907|NCT03131687|147190830|OTHER||Posterior Mean Difference|-1.0|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
73821908|NCT03131687|147190830|OTHER||Posterior Mean Difference|-1.67|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
73821909|NCT03131687|147190830|OTHER||Posterior Mean Difference|-1.83|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
73821910|NCT03131687|147190830|OTHER||Posterior Mean Difference|-1.89|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
73821911|NCT03131687|147190831|OTHER||Posterior Mean Difference|-0.89|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
73821912|NCT03131687|147190831|OTHER||Posterior Mean Difference|-1.49|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
73821913|NCT03131687|147190831|OTHER||Posterior Mean Difference|-1.62|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
73821914|NCT03131687|147190831|OTHER||Posterior Mean Difference|-1.67|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
73821915|NCT03131687|147190832|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Models Analysis|||||-0.4|-1.2|<0.001
73821916|NCT03131687|147190832|OTHER||Median Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.2|-1.3|||Mixed Models Analysis|||||-1.3|-2.2|<0.001
73821917|NCT03131687|147190832|OTHER||Median Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-2.5|-1.6|||Mixed Models Analysis|||||-1.6|-2.5|<0.001
73821918|NCT03131687|147190832|OTHER||Median Difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-2.9|-2.0|||Mixed Models Analysis|||||-2.0|-2.9|<0.001
73821919|NCT03131687|147190833|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
73821920|NCT03131687|147190833|OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.0|-1.3|||Mixed Models Analysis|||||-1.3|-2.0|<0.001
73821921|NCT03131687|147190833|OTHER||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.3|-1.5|||Mixed Models Analysis|||||-1.5|-2.3|<0.001
73821922|NCT03131687|147190833|OTHER||Mean Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-2.4|-1.7|||Mixed Models Analysis|||||-1.7|-2.4|<0.001
73821923|NCT03131687|147190834|OTHER||Mean Difference (Final Values)|-0.5||||0.655|TWO_SIDED|95.0|-2.7|1.7|||Mixed Models Analysis|||||1.7|-2.7|0.655
73821924|NCT03131687|147190834|OTHER||Mean Difference (Final Values)|-4.4|||<|0.001|TWO_SIDED|95.0|-6.6|-2.3|||Mixed Models Analysis|||||-2.3|-6.6|<0.001
73821925|NCT03131687|147190834|OTHER||Mean Difference (Final Values)|-8.3|||<|0.001|TWO_SIDED|95.0|-10.5|-6.0|||Mixed Models Analysis|||||-6.0|-10.5|<0.001
73821926|NCT03131687|147190834|OTHER||Median Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-13.3|-8.6|||Mixed Models Analysis|||||-8.6|-13.3|<0.001
73821927|NCT03131687|147190835|OTHER|||||||0.053|||||||Regression, Logistic|||||||0.053
73821928|NCT03131687|147190835|OTHER|||||||0.002|||||||Regression, Logistic|||||||0.002
73821929|NCT03131687|147190835|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73821930|NCT03131687|147190835|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73821931|NCT03131687|147190836|OTHER|||||||0.193|||||||Regression, Logistic|||||||0.193
73821932|NCT03131687|147190836|OTHER|||||||0.036|||||||Regression, Logistic|||||||0.036
73821933|NCT03131687|147190836|OTHER|||||||0.003|||||||Regression, Logistic|||||||0.003
73821934|NCT03131687|147190836|OTHER|||||||0.003|||||||Regression, Logistic|||||||0.003
73821935|NCT03131687|147190837|OTHER|||||||0.03|||||||Regression, Logistic|||||||0.030
73821936|NCT03131687|147190837|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73821937|NCT03131687|147190837|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73821938|NCT03131687|147190837|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73821939|NCT03131687|147190838|OTHER|||||||0.008|||||||Regression, Logistic|||||||0.008
73821940|NCT03131687|147190838|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73821941|NCT03131687|147190838|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73821942|NCT03131687|147190838|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73821943|NCT03131687|147190839|OTHER||Mean Difference (Final Values)|-22.4||||0.01|TWO_SIDED|95.0|-39.4|-5.3|||Mixed Models Analysis|||||-5.3|-39.4|0.010
73821944|NCT03131687|147190839|OTHER||Mean Difference (Final Values)|-56.2|||<|0.001|TWO_SIDED|95.0|-72.9|-39.5|||Mixed Models Analysis|||||-39.5|-72.9|<0.001
73821945|NCT03131687|147190839|OTHER||Odds Ratio (OR)|-76.3|||<|0.001|TWO_SIDED|95.0|-93.3|-59.2|||Mixed Models Analysis|||||-59.2|-93.3|<0.001
73821946|NCT03131687|147190839|OTHER||Mean Difference (Final Values)|-73.0|||<|0.001|TWO_SIDED|95.0|-90.9|-55.2|||Mixed Models Analysis|||||-55.2|-90.9|<0.001
73821947|NCT03131687|147190840|OTHER||Mean Difference (Final Values)|0.0||||0.396|TWO_SIDED|95.0|-0.1|0.0|||Mixed Models Analysis|||||0.0|-0.1|0.396
73821948|NCT03131687|147190840|OTHER||Mean Difference (Final Values)|0.0||||0.903|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.1|-0.1|0.903
73821949|NCT03131687|147190840|OTHER||Mean Difference (Final Values)|0.0||||0.536|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.1|-0.1|0.536
73821950|NCT03131687|147190840|OTHER||Mean Difference (Final Values)|0.0||||0.325|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||||0.1|-0.0|0.325
73821951|NCT03131687|147190841|OTHER||Mean Difference (Final Values)|-0.1||||0.565|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||||0.2|-0.4|0.565
73821952|NCT03131687|147190841|OTHER||Mean Difference (Final Values)|-0.4||||0.01|TWO_SIDED|95.0|-0.7|-0.1|||Mixed Models Analysis|||||-0.1|-0.7|0.010
73821953|NCT03131687|147190841|OTHER||Median Difference (Final Values)|-0.5||||0.001|TWO_SIDED|95.0|-0.9|-0.2|||Mixed Models Analysis|||||-0.2|-0.9|0.001
73821954|NCT03131687|147190841|OTHER||Median Difference (Final Values)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Models Analysis|||||-0.3|-0.9|<0.001
73821955|NCT03131687|147190842|OTHER||Mean Difference (Final Values)|-0.3||||0.164|TWO_SIDED|95.0|-0.7|0.1|||Mixed Models Analysis|||||0.1|-0.7|0.164
73821956|NCT03131687|147190842|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
73821957|NCT03131687|147190842|OTHER||Mean Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||||-0.6|-1.4|<0.001
73821958|NCT03131687|147190842|OTHER||Median Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Models Analysis|||||-0.7|-1.5|<0.001
73821959|NCT03131687|147190843|OTHER||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.919
73821960|NCT03131687|147190843|OTHER||Mean Difference (Final Values)|-0.2||||0.194|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|0.194
73821961|NCT03131687|147190843|OTHER||Mean Difference (Final Values)|-0.2||||0.145|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|0.145
73821962|NCT03131687|147190843|OTHER||Mean Difference (Final Values)|-0.3||||0.067|TWO_SIDED|95.0|-0.6|0.0|||Mixed Models Analysis|||||0.0|-0.6|0.067
73821963|NCT03131687|147190844|OTHER||Mean Difference (Final Values)|-0.7||||0.539|TWO_SIDED|95.0|-3.1|1.6|||Mixed Models Analysis|||||1.6|-3.1|0.539
73821964|NCT03131687|147190844|OTHER||Mean Difference (Final Values)|-3.8||||0.001|TWO_SIDED|95.0|-6.1|-1.5|||Mixed Models Analysis|||||-1.5|-6.1|0.001
73821965|NCT03131687|147190844|OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-8.4|-3.7|||Mixed Models Analysis|||||-3.7|-8.4|<0.001
73821966|NCT03131687|147190844|OTHER||Mean Difference (Final Values)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.3|-6.4|||Mixed Models Analysis|||||-6.4|-11.3|<0.001
73821967|NCT03365934|147190907|SUPERIORITY|||||||0.071225|||||||t-test, 2 sided|||||||0.071225
73821968|NCT03365934|147190907|SUPERIORITY|||||||0.092027|||||||t-test, 2 sided|||||||0.092027
73821969|NCT03365934|147190907|SUPERIORITY|||||||0.601716|||||||t-test, 2 sided|||||||0.601716
73821970|NCT03365934|147190907|SUPERIORITY|||||||0.639911|||||||t-test, 2 sided|||||||0.639911
73821971|NCT03365934|147190907|SUPERIORITY|||||||0.842476|||||||t-test, 2 sided|||||||0.842476
73821972|NCT03365934|147190907|SUPERIORITY|||||||0.999941|||||||t-test, 2 sided|||||||0.999941
73821973|NCT03365934|147190907|SUPERIORITY|||||||0.883479|||||||t-test, 2 sided|||||||0.883479
73821974|NCT03365934|147190907|SUPERIORITY|||||||0.782208|||||||t-test, 2 sided|||||||0.782208
73821975|NCT03365934|147190907|SUPERIORITY|||||||0.607134|||||||t-test, 2 sided|||||||0.607134
73821976|NCT03365934|147190907|SUPERIORITY|||||||0.939549|||||||t-test, 2 sided|||||||0.939549
73821977|NCT03365934|147190907|SUPERIORITY|||||||0.86475|||||||t-test, 2 sided|||||||0.86475
73821978|NCT03365934|147190907|SUPERIORITY|||||||0.704759|||||||t-test, 2 sided|||||||0.704759
73821979|NCT03365934|147190907|SUPERIORITY|||||||0.999989|||||||t-test, 2 sided|||||||0.999989
73821980|NCT03365934|147190907|SUPERIORITY|||||||0.997568|||||||t-test, 2 sided|||||||0.997568
73821981|NCT03365934|147190907|SUPERIORITY|||||||0.999518|||||||t-test, 2 sided|||||||0.999518
73821982|NCT03365934|147190908|SUPERIORITY|||||||0.985332|||||||t-test, 2 sided|||||||0.985332
73821983|NCT03365934|147190908|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
73821984|NCT03365934|147190908|SUPERIORITY|||||||0.870459|||||||t-test, 2 sided|||||||0.870459
73821985|NCT03365934|147190908|SUPERIORITY|||||||0.004963|||||||t-test, 2 sided|||||||0.004963
73821986|NCT03365934|147190908|SUPERIORITY|||||||0.071935|||||||t-test, 2 sided|||||||0.071935
73821987|NCT03365934|147190908|SUPERIORITY|||||||0.988995|||||||t-test, 2 sided|||||||0.988995
73821988|NCT03365934|147190908|SUPERIORITY|||||||0.545378|||||||t-test, 2 sided|||||||0.545378
73821989|NCT03365934|147190908|SUPERIORITY|||||||0.000649|||||||t-test, 2 sided|||||||0.000649
73821990|NCT03365934|147190908|SUPERIORITY|||||||0.0146|||||||t-test, 2 sided|||||||0.014600
73821991|NCT03365934|147190908|SUPERIORITY|||||||0.854566|||||||t-test, 2 sided|||||||0.854566
73821992|NCT03365934|147190908|SUPERIORITY|||||||0.004322|||||||t-test, 2 sided|||||||0.004322
73821993|NCT03365934|147190908|SUPERIORITY|||||||0.0651|||||||t-test, 2 sided|||||||0.0651
73821994|NCT03365934|147190908|SUPERIORITY|||||||0.300536|||||||t-test, 2 sided|||||||0.300536
73821995|NCT03365934|147190908|SUPERIORITY|||||||0.753883|||||||t-test, 2 sided|||||||0.753883
73821996|NCT03365934|147190908|SUPERIORITY|||||||0.97621|||||||t-test, 2 sided|||||||0.97621
73821997|NCT03365934|147190909|SUPERIORITY|||||||0.027774|||||||t-test, 2 sided|||||||0.027774
73821998|NCT03365934|147190909|SUPERIORITY|||||||0.08431|||||||t-test, 2 sided|||||||0.08431
73821999|NCT03365934|147190909|SUPERIORITY|||||||0.049247|||||||t-test, 2 sided|||||||0.049247
73822000|NCT03365934|147190909|SUPERIORITY|||||||0.000126|||||||t-test, 2 sided|||||||0.000126
73822001|NCT03365934|147190909|SUPERIORITY|||||||0.010829|||||||t-test, 2 sided|||||||0.010829
73822002|NCT03365934|147190909|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822003|NCT03365934|147190909|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822004|NCT03365934|147190909|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822005|NCT03365934|147190909|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822006|NCT03365934|147190909|SUPERIORITY|||||||0.999533|||||||t-test, 2 sided|||||||0.999533
73822007|NCT03365934|147190909|SUPERIORITY|||||||0.4205363|||||||t-test, 2 sided|||||||0.4205363
73822008|NCT03365934|147190909|SUPERIORITY|||||||0.9802252|||||||t-test, 2 sided|||||||0.9802252
73822009|NCT03365934|147190909|SUPERIORITY|||||||0.6845362|||||||t-test, 2 sided|||||||0.6845362
73822010|NCT03365934|147190909|SUPERIORITY|||||||0.9992002|||||||t-test, 2 sided|||||||0.9992002
73822011|NCT03365934|147190909|SUPERIORITY|||||||0.8562779|||||||t-test, 2 sided|||||||0.8562779
73822012|NCT03365934|147190910|SUPERIORITY|||||||0.0403539|||||||t-test, 2 sided|||||||0.0403539
73822013|NCT03365934|147190910|SUPERIORITY|||||||0.2953049|||||||t-test, 2 sided|||||||0.2953049
73822014|NCT03365934|147190910|SUPERIORITY|||||||0.290551|||||||t-test, 2 sided|||||||0.290551
73822015|NCT03365934|147190910|SUPERIORITY|||||||2.47e-05|||||||t-test, 2 sided|||||||0.0000247
73822016|NCT03365934|147190910|SUPERIORITY|||||||0.0133001|||||||t-test, 2 sided|||||||0.0133001
73822017|NCT03365934|147190910|SUPERIORITY|||||||1.67e-05|||||||t-test, 2 sided|||||||0.0000167
73822018|NCT03365934|147190910|SUPERIORITY|||||||2.12e-05|||||||t-test, 2 sided|||||||0.0000212
73822019|NCT03365934|147190910|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822020|NCT03365934|147190910|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822021|NCT03365934|147190910|SUPERIORITY|||||||0.99999995|||||||t-test, 2 sided|||||||0.99999995
73822022|NCT03365934|147190910|SUPERIORITY|||||||0.0792013|||||||t-test, 2 sided|||||||0.0792013
73822023|NCT03365934|147190910|SUPERIORITY|||||||0.870163|||||||t-test, 2 sided|||||||0.870163
73822024|NCT03365934|147190910|SUPERIORITY|||||||0.103828|||||||t-test, 2 sided|||||||0.103828
73822025|NCT03365934|147190910|SUPERIORITY|||||||0.900265|||||||t-test, 2 sided|||||||0.900265
73822026|NCT03365934|147190910|SUPERIORITY|||||||0.570015|||||||t-test, 2 sided|||||||0.570015
73822027|NCT03365934|147190911|SUPERIORITY|||||||0.882449|||||||t-test, 2 sided|||||||0.882449
73822028|NCT03365934|147190911|SUPERIORITY|||||||0.088558|||||||t-test, 2 sided|||||||0.088558
73822029|NCT03365934|147190911|SUPERIORITY|||||||0.081846|||||||t-test, 2 sided|||||||0.081846
73822030|NCT03365934|147190911|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822031|NCT03365934|147190911|SUPERIORITY|||||||3.03e-05|||||||t-test, 2 sided|||||||0.0000303
73822032|NCT03365934|147190911|SUPERIORITY|||||||0.001817|||||||t-test, 2 sided|||||||0.001817
73822033|NCT03365934|147190911|SUPERIORITY|||||||0.001825|||||||t-test, 2 sided|||||||0.001825
73822034|NCT03365934|147190911|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822035|NCT03365934|147190911|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822036|NCT03365934|147190911|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
73822037|NCT03365934|147190911|SUPERIORITY|||||||0.038836|||||||t-test, 2 sided|||||||0.038836
73822038|NCT03365934|147190911|SUPERIORITY|||||||0.184508|||||||t-test, 2 sided|||||||0.184508
73822039|NCT03365934|147190911|SUPERIORITY|||||||0.062829|||||||t-test, 2 sided|||||||0.062829
73822040|NCT03365934|147190911|SUPERIORITY|||||||0.253458|||||||t-test, 2 sided|||||||0.253458
73822041|NCT03365934|147190911|SUPERIORITY|||||||0.987798|||||||t-test, 2 sided|||||||0.987798
73822042|NCT03365934|147190912|SUPERIORITY|||||||0.516068|||||||t-test, 2 sided|||||||0.516068
73822043|NCT03365934|147190912|SUPERIORITY|||||||0.358412|||||||t-test, 2 sided|||||||0.358412
73822044|NCT03365934|147190912|SUPERIORITY|||||||0.834145|||||||t-test, 2 sided|||||||0.834145
73822045|NCT03365934|147190912|SUPERIORITY|||||||3.5e-05|||||||t-test, 2 sided|||||||0.000035
73822046|NCT03365934|147190912|SUPERIORITY|||||||0.000843|||||||t-test, 2 sided|||||||0.000843
73822047|NCT03365934|147190912|SUPERIORITY|||||||0.002997|||||||t-test, 2 sided|||||||0.002997
73822048|NCT03365934|147190912|SUPERIORITY|||||||0.051717|||||||t-test, 2 sided|||||||0.051717
73822049|NCT03365934|147190912|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822050|NCT03365934|147190912|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822051|NCT03365934|147190912|SUPERIORITY|||||||0.985602|||||||t-test, 2 sided|||||||0.985602
73822052|NCT03365934|147190912|SUPERIORITY|||||||0.046422|||||||t-test, 2 sided|||||||0.046422
73822053|NCT03365934|147190912|SUPERIORITY|||||||0.28061|||||||t-test, 2 sided|||||||0.28061
73822054|NCT03365934|147190912|SUPERIORITY|||||||0.011015|||||||t-test, 2 sided|||||||0.011015
73822055|NCT03365934|147190912|SUPERIORITY|||||||0.089156|||||||t-test, 2 sided|||||||0.089156
73822056|NCT03365934|147190912|SUPERIORITY|||||||0.963882|||||||t-test, 2 sided|||||||0.963882
73822057|NCT03365934|147190913|SUPERIORITY|||||||0.00526|||||||t-test, 2 sided|||||||0.00526
73822058|NCT03365934|147190913|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
73822059|NCT03365934|147190913|SUPERIORITY|||||||0.914409|||||||t-test, 2 sided|||||||0.914409
73822060|NCT03365934|147190913|SUPERIORITY|||||||0.013004|||||||t-test, 2 sided|||||||0.013004
73822061|NCT03365934|147190913|SUPERIORITY|||||||0.028517|||||||t-test, 2 sided|||||||0.028517
73822062|NCT03365934|147190913|SUPERIORITY|||||||0.001356|||||||t-test, 2 sided|||||||0.001356
73822063|NCT03365934|147190913|SUPERIORITY|||||||5.9e-05|||||||t-test, 2 sided|||||||0.000059
73822064|NCT03365934|147190913|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822065|NCT03365934|147190913|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822066|NCT03365934|147190913|SUPERIORITY|||||||0.859272|||||||t-test, 2 sided|||||||0.859272
73822067|NCT03365934|147190913|SUPERIORITY|||||||0.002821|||||||t-test, 2 sided|||||||0.002821
73822068|NCT03365934|147190913|SUPERIORITY|||||||0.007492|||||||t-test, 2 sided|||||||0.007492
73822069|NCT03365934|147190913|SUPERIORITY|||||||0.208803|||||||t-test, 2 sided|||||||0.208803
73822070|NCT03365934|147190913|SUPERIORITY|||||||0.341884|||||||t-test, 2 sided|||||||0.341884
73822071|NCT03365934|147190913|SUPERIORITY|||||||0.999531|||||||t-test, 2 sided|||||||0.999531
73822072|NCT03365934|147190914|SUPERIORITY|||||||0.066788|||||||t-test, 2 sided|||||||0.066788
73822073|NCT03365934|147190914|SUPERIORITY|||||||0.942653|||||||t-test, 2 sided|||||||0.942653
73822074|NCT03365934|147190914|SUPERIORITY|||||||0.893545|||||||t-test, 2 sided|||||||0.893545
73822075|NCT03365934|147190914|SUPERIORITY|||||||0.165225|||||||t-test, 2 sided|||||||0.165225
73822076|NCT03365934|147190914|SUPERIORITY|||||||0.140475|||||||t-test, 2 sided|||||||0.140475
73822077|NCT03365934|147190914|SUPERIORITY|||||||0.002026|||||||t-test, 2 sided|||||||0.002026
73822078|NCT03365934|147190914|SUPERIORITY|||||||0.001916|||||||t-test, 2 sided|||||||0.001916
73822079|NCT03365934|147190914|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822080|NCT03365934|147190914|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822081|NCT03365934|147190914|SUPERIORITY|||||||0.999957|||||||t-test, 2 sided|||||||0.999957
73822082|NCT03365934|147190914|SUPERIORITY|||||||0.672573|||||||t-test, 2 sided|||||||0.672573
73822083|NCT03365934|147190914|SUPERIORITY|||||||0.630145|||||||t-test, 2 sided|||||||0.630145
73822084|NCT03365934|147190914|SUPERIORITY|||||||0.832757|||||||t-test, 2 sided|||||||0.832757
73822085|NCT03365934|147190914|SUPERIORITY|||||||0.803277|||||||t-test, 1 sided|||||||0.803277
73822086|NCT03365934|147190914|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
73822087|NCT03365934|147190915|SUPERIORITY|||||||0.943522|||||||t-test, 2 sided|||||||0.943522
73822088|NCT03365934|147190915|SUPERIORITY|||||||0.002376|||||||t-test, 2 sided|||||||0.002376
73822089|NCT03365934|147190915|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822090|NCT03365934|147190915|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822091|NCT03365934|147190915|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822092|NCT03365934|147190915|SUPERIORITY|||||||0.061015|||||||t-test, 2 sided|||||||0.061015
73822093|NCT03365934|147190915|SUPERIORITY|||||||0.000211|||||||t-test, 2 sided|||||||0.000211
73822094|NCT03365934|147190915|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822095|NCT03365934|147190915|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822096|NCT03365934|147190915|SUPERIORITY|||||||0.412626|||||||t-test, 2 sided|||||||0.412626
73822097|NCT03365934|147190915|SUPERIORITY|||||||0.104388|||||||t-test, 2 sided|||||||0.104388
73822098|NCT03365934|147190915|SUPERIORITY|||||||0.197791|||||||t-test, 2 sided|||||||0.197791
73822099|NCT03365934|147190915|SUPERIORITY|||||||0.994413|||||||t-test, 2 sided|||||||0.994413
73822100|NCT03365934|147190915|SUPERIORITY|||||||0.999851|||||||t-test, 2 sided|||||||0.999851
73822101|NCT03365934|147190915|SUPERIORITY|||||||0.999621|||||||t-test, 2 sided|||||||0.999621
73822102|NCT03365934|147190916|SUPERIORITY|||||||0.193667|||||||t-test, 2 sided|||||||0.193667
73822103|NCT03365934|147190916|SUPERIORITY|||||||0.526573|||||||t-test, 2 sided|||||||0.526573
73822104|NCT03365934|147190916|SUPERIORITY|||||||0.898749|||||||t-test, 2 sided|||||||0.898749
73822105|NCT03365934|147190916|SUPERIORITY|||||||0.975044|||||||t-test, 2 sided|||||||0.975044
73822106|NCT03365934|147190916|SUPERIORITY|||||||0.760706|||||||t-test, 2 sided|||||||0.760706
73822107|NCT03365934|147190916|SUPERIORITY|||||||0.985237|||||||t-test, 2 sided|||||||0.985237
73822108|NCT03365934|147190916|SUPERIORITY|||||||0.837995|||||||t-test, 2 sided|||||||0.837995
73822109|NCT03365934|147190916|SUPERIORITY|||||||0.592697|||||||t-test, 2 sided|||||||0.592697
73822110|NCT03365934|147190916|SUPERIORITY|||||||0.912495|||||||t-test, 2 sided|||||||0.912495
73822111|NCT03365934|147190916|SUPERIORITY|||||||0.99245|||||||t-test, 2 sided|||||||0.99245
73822112|NCT03365934|147190916|SUPERIORITY|||||||0.925553|||||||t-test, 2 sided|||||||0.925553
73822113|NCT03365934|147190916|SUPERIORITY|||||||0.999171|||||||t-test, 2 sided|||||||0.999171
73822114|NCT03365934|147190916|SUPERIORITY|||||||0.999324|||||||t-test, 2 sided|||||||0.999324
73822115|NCT03365934|147190916|SUPERIORITY|||||||0.999913|||||||t-test, 2 sided|||||||0.999913
73822116|NCT03365934|147190916|SUPERIORITY|||||||0.990516|||||||t-test, 2 sided|||||||0.990516
73822117|NCT03365934|147190917|SUPERIORITY|||||||0.92106|||||||t-test, 2 sided|||||||0.92106
73822118|NCT03365934|147190917|SUPERIORITY|||||||0.976812|||||||t-test, 2 sided|||||||0.976812
73822119|NCT03365934|147190917|SUPERIORITY|||||||0.233992|||||||t-test, 2 sided|||||||0.233992
73822120|NCT03365934|147190917|SUPERIORITY|||||||0.007591|||||||t-test, 2 sided|||||||0.007591
73822121|NCT03365934|147190917|SUPERIORITY|||||||0.038958|||||||t-test, 2 sided|||||||0.038958
73822122|NCT03365934|147190917|SUPERIORITY|||||||0.99809|||||||t-test, 2 sided|||||||0.99809
73822123|NCT03365934|147190917|SUPERIORITY|||||||0.773028|||||||t-test, 2 sided|||||||0.773028
73822124|NCT03365934|147190917|SUPERIORITY|||||||0.135805|||||||t-test, 2 sided|||||||0.135805
73822125|NCT03365934|147190917|SUPERIORITY|||||||0.350556|||||||t-test, 2 sided|||||||0.350556
73822126|NCT03365934|147190917|SUPERIORITY|||||||0.61046|||||||t-test, 2 sided|||||||0.61046
73822127|NCT03365934|147190917|SUPERIORITY|||||||0.062163|||||||t-test, 2 sided|||||||0.062163
73822128|NCT03365934|147190917|SUPERIORITY|||||||0.203418|||||||t-test, 2 sided|||||||0.203418
73822129|NCT03365934|147190917|SUPERIORITY|||||||0.942304|||||||t-test, 2 sided|||||||0.942304
73822130|NCT03365934|147190917|SUPERIORITY|||||||0.995238|||||||t-test, 2 sided|||||||0.995238
73822131|NCT03365934|147190917|SUPERIORITY|||||||0.99858|||||||t-test, 2 sided|||||||0.99858
73822132|NCT03365934|147190918|SUPERIORITY|||||||0.998949|||||||t-test, 2 sided|||||||0.998949
73822133|NCT03365934|147190918|SUPERIORITY|||||||0.111084|||||||t-test, 2 sided|||||||0.111084
73822134|NCT03365934|147190918|SUPERIORITY|||||||0.456846|||||||t-test, 2 sided|||||||0.456846
73822135|NCT03365934|147190918|SUPERIORITY|||||||0.00062|||||||t-test, 2 sided|||||||0.00062
73822136|NCT03365934|147190918|SUPERIORITY|||||||0.006871|||||||t-test, 2 sided|||||||0.006871
73822137|NCT03365934|147190918|SUPERIORITY|||||||0.039407|||||||t-test, 2 sided|||||||0.039407
73822138|NCT03365934|147190918|SUPERIORITY|||||||0.245375|||||||t-test, 2 sided|||||||0.245375
73822139|NCT03365934|147190918|SUPERIORITY|||||||0.000113|||||||t-test, 2 sided|||||||0.000113
73822140|NCT03365934|147190918|SUPERIORITY|||||||0.001612|||||||t-test, 2 sided|||||||0.001612
73822141|NCT03365934|147190918|SUPERIORITY|||||||0.988067|||||||t-test, 2 sided|||||||0.988067
73822142|NCT03365934|147190918|SUPERIORITY|||||||0.599171|||||||t-test, 2 sided|||||||0.599171
73822143|NCT03365934|147190918|SUPERIORITY|||||||0.928722|||||||t-test, 2 sided|||||||0.928722
73822144|NCT03365934|147190918|SUPERIORITY|||||||0.256079|||||||t-test, 2 sided|||||||0.256079
73822145|NCT03365934|147190918|SUPERIORITY|||||||0.626498|||||||t-test, 2 sided|||||||0.626498
73822146|NCT03365934|147190918|SUPERIORITY|||||||0.988693|||||||t-test, 2 sided|||||||0.988693
73822147|NCT03365934|147190919|SUPERIORITY|||||||0.99916|||||||t-test, 2 sided|||||||0.99916
73822148|NCT03365934|147190919|SUPERIORITY|||||||0.016246|||||||t-test, 2 sided|||||||0.016246
73822149|NCT03365934|147190919|SUPERIORITY|||||||0.289112|||||||t-test, 2 sided|||||||0.289112
73822150|NCT03365934|147190919|SUPERIORITY|||||||3.8e-05|||||||t-test, 2 sided|||||||0.000038
73822151|NCT03365934|147190919|SUPERIORITY|||||||0.014558|||||||t-test, 2 sided|||||||0.014558
73822152|NCT03365934|147190919|SUPERIORITY|||||||0.03731|||||||t-test, 2 sided|||||||0.03731
73822153|NCT03365934|147190919|SUPERIORITY|||||||0.465745|||||||t-test, 2 sided|||||||0.465745
73822154|NCT03365934|147190919|SUPERIORITY|||||||0.000112|||||||t-test, 2 sided|||||||0.000112
73822155|NCT03365934|147190919|SUPERIORITY|||||||0.034575|||||||t-test, 2 sided|||||||0.034575
73822156|NCT03365934|147190919|SUPERIORITY|||||||0.889597|||||||t-test, 2 sided|||||||0.889597
73822157|NCT03365934|147190919|SUPERIORITY|||||||0.726932|||||||t-test, 2 sided|||||||0.726932
73822158|NCT03365934|147190919|SUPERIORITY|||||||0.999998|||||||t-test, 2 sided|||||||0.999998
73822159|NCT03365934|147190919|SUPERIORITY|||||||0.130235|||||||t-test, 2 sided|||||||0.130235
73822160|NCT03365934|147190919|SUPERIORITY|||||||0.910989|||||||t-test, 2 sided|||||||0.910989
73822161|NCT03365934|147190919|SUPERIORITY|||||||0.616933|||||||t-test, 2 sided|||||||0.616933
73822162|NCT03365934|147190920|SUPERIORITY|||||||0.999952|||||||t-test, 2 sided|||||||0.999952
73822163|NCT03365934|147190920|SUPERIORITY|||||||0.421347|||||||t-test, 2 sided|||||||0.421347
73822164|NCT03365934|147190920|SUPERIORITY|||||||0.598141|||||||t-test, 2 sided|||||||0.598141
73822165|NCT03365934|147190920|SUPERIORITY|||||||0.000197|||||||t-test, 2 sided|||||||0.000197
73822166|NCT03365934|147190920|SUPERIORITY|||||||0.000115|||||||t-test, 2 sided|||||||0.000115
73822167|NCT03365934|147190920|SUPERIORITY|||||||0.511155|||||||t-test, 2 sided|||||||0.511155
73822168|NCT03365934|147190920|SUPERIORITY|||||||0.693868|||||||t-test, 2 sided|||||||0.693868
73822169|NCT03365934|147190920|SUPERIORITY|||||||0.000232|||||||t-test, 2 sided|||||||0.000232
73822170|NCT03365934|147190920|SUPERIORITY|||||||0.000133|||||||t-test, 2 sided|||||||0.000133
73822171|NCT03365934|147190920|SUPERIORITY|||||||0.999894|||||||t-test, 2 sided|||||||0.999894
73822172|NCT03365934|147190920|SUPERIORITY|||||||0.078046|||||||t-test, 2 sided|||||||0.078046
73822173|NCT03365934|147190920|SUPERIORITY|||||||0.054975|||||||t-test, 2 sided|||||||0.054975
73822174|NCT03365934|147190920|SUPERIORITY|||||||0.050132|||||||t-test, 2 sided|||||||0.050132
73822175|NCT03365934|147190920|SUPERIORITY|||||||0.034793|||||||t-test, 2 sided|||||||0.034793
73822176|NCT03365934|147190920|SUPERIORITY|||||||0.999993|||||||t-test, 2 sided|||||||0.999993
73822177|NCT03365934|147190921|SUPERIORITY|||||||0.997406|||||||t-test, 2 sided|||||||0.997406
73822178|NCT03365934|147190921|SUPERIORITY|||||||0.354187|||||||t-test, 2 sided|||||||0.354187
73822179|NCT03365934|147190921|SUPERIORITY|||||||0.883222|||||||t-test, 2 sided|||||||0.883222
73822180|NCT03365934|147190921|SUPERIORITY|||||||0.000412|||||||t-test, 2 sided|||||||0.000412
73822181|NCT03365934|147190921|SUPERIORITY|||||||0.000332|||||||t-test, 2 sided|||||||0.000332
73822182|NCT03365934|147190921|SUPERIORITY|||||||0.626878|||||||t-test, 2 sided|||||||0.626878
73822183|NCT03365934|147190921|SUPERIORITY|||||||0.984465|||||||t-test, 2 sided|||||||0.984465
73822184|NCT03365934|147190921|SUPERIORITY|||||||0.001845|||||||t-test, 2 sided|||||||0.001845
73822185|NCT03365934|147190921|SUPERIORITY|||||||0.001507|||||||t-test, 2 sided|||||||0.001507
73822186|NCT03365934|147190921|SUPERIORITY|||||||0.970029|||||||t-test, 2 sided|||||||0.970029
73822187|NCT03365934|147190921|SUPERIORITY|||||||0.19886|||||||t-test, 2 sided|||||||0.19886
73822188|NCT03365934|147190921|SUPERIORITY|||||||0.177549|||||||t-test, 2 sided|||||||0.177549
73822189|NCT03365934|147190921|SUPERIORITY|||||||0.041698|||||||t-test, 2 sided|||||||0.041698
73822190|NCT03365934|147190921|SUPERIORITY|||||||0.036131|||||||t-test, 2 sided|||||||0.036131
73822191|NCT03365934|147190921|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
73822192|NCT03365934|147190922|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
73822193|NCT03365934|147190922|SUPERIORITY|||||||0.317315|||||||t-test, 2 sided|||||||0.317315
73822194|NCT03365934|147190922|SUPERIORITY|||||||0.829352|||||||t-test, 2 sided|||||||0.829352
73822195|NCT03365934|147190922|SUPERIORITY|||||||0.010561|||||||t-test, 2 sided|||||||0.010561
73822196|NCT03365934|147190922|SUPERIORITY|||||||0.001099|||||||t-test, 2 sided|||||||0.001099
73822197|NCT03365934|147190922|SUPERIORITY|||||||0.175148|||||||t-test, 2 sided|||||||0.175148
73822198|NCT03365934|147190922|SUPERIORITY|||||||0.728796|||||||t-test, 2 sided|||||||0.728796
73822199|NCT03365934|147190922|SUPERIORITY|||||||0.001992|||||||t-test, 2 sided|||||||0.001992
73822200|NCT03365934|147190922|SUPERIORITY|||||||0.000113|||||||t-test, 2 sided|||||||0.000113
73822201|NCT03365934|147190922|SUPERIORITY|||||||0.974567|||||||t-test, 2 sided|||||||0.974567
73822202|NCT03365934|147190922|SUPERIORITY|||||||0.668933|||||||t-test, 2 sided|||||||0.668933
73822203|NCT03365934|147190922|SUPERIORITY|||||||0.239446|||||||t-test, 2 sided|||||||0.239446
73822204|NCT03365934|147190922|SUPERIORITY|||||||0.283848|||||||t-test, 2 sided|||||||0.283848
73822205|NCT03365934|147190922|SUPERIORITY|||||||0.06829|||||||t-test, 2 sided|||||||0.06829
73822206|NCT03365934|147190922|SUPERIORITY|||||||0.979516|||||||t-test, 2 sided|||||||0.979516
73822207|NCT03365934|147190923|SUPERIORITY|||||||0.996522|||||||t-test, 2 sided|||||||0.996522
73822208|NCT03365934|147190923|SUPERIORITY|||||||0.875832|||||||t-test, 2 sided|||||||0.875832
73822209|NCT03365934|147190923|SUPERIORITY|||||||0.938|||||||t-test, 2 sided|||||||0.938
73822210|NCT03365934|147190923|SUPERIORITY|||||||0.038527|||||||t-test, 2 sided|||||||0.038527
73822211|NCT03365934|147190923|SUPERIORITY|||||||0.018334|||||||t-test, 2 sided|||||||0.018334
73822212|NCT03365934|147190923|SUPERIORITY|||||||0.512209|||||||t-test, 2 sided|||||||0.512209
73822213|NCT03365934|147190923|SUPERIORITY|||||||0.665529|||||||t-test, 2 sided|||||||0.665529
73822214|NCT03365934|147190923|SUPERIORITY|||||||0.002257|||||||t-test, 2 sided|||||||0.002257
73822215|NCT03365934|147190923|SUPERIORITY|||||||0.000728|||||||t-test, 2 sided|||||||0.000728
73822216|NCT03365934|147190923|SUPERIORITY|||||||0.999993|||||||t-test, 2 sided|||||||0.999993
73822217|NCT03365934|147190923|SUPERIORITY|||||||0.417914|||||||t-test, 2 sided|||||||0.417914
73822218|NCT03365934|147190923|SUPERIORITY|||||||0.277469|||||||t-test, 2 sided|||||||0.277469
73822219|NCT03365934|147190923|SUPERIORITY|||||||0.385419|||||||t-test, 2 sided|||||||0.385419
73822220|NCT03365934|147190923|SUPERIORITY|||||||0.257647|||||||t-test, 2 sided|||||||0.257647
73822221|NCT03365934|147190923|SUPERIORITY|||||||0.999897|||||||t-test, 2 sided|||||||0.999897
73822222|NCT03365934|147190924|SUPERIORITY|||||||0.862516|||||||t-test, 2 sided|||||||0.862516
73822223|NCT03365934|147190924|SUPERIORITY|||||||0.00473|||||||t-test, 2 sided|||||||0.00473
73822224|NCT03365934|147190924|SUPERIORITY|||||||0.085238|||||||t-test, 2 sided|||||||0.085238
73822225|NCT03365934|147190924|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822226|NCT03365934|147190924|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73822227|NCT03365934|147190924|SUPERIORITY|||||||0.168409|||||||t-test, 2 sided|||||||0.168409
73822228|NCT03365934|147190924|SUPERIORITY|||||||0.652654|||||||t-test, 2 sided|||||||0.652654
73822229|NCT03365934|147190924|SUPERIORITY|||||||0.001436|||||||t-test, 2 sided|||||||0.001436
73822230|NCT03365934|147190924|SUPERIORITY|||||||0.000235|||||||t-test, 2 sided|||||||0.000235
73822231|NCT03365934|147190924|SUPERIORITY|||||||0.974842|||||||t-test, 2 sided|||||||0.974842
73822232|NCT03365934|147190924|SUPERIORITY|||||||0.557877|||||||t-test, 2 sided|||||||0.557877
73822233|NCT03365934|147190924|SUPERIORITY|||||||0.277244|||||||t-test, 2 sided|||||||0.277244
73822234|NCT03365934|147190924|SUPERIORITY|||||||0.195527|||||||t-test, 2 sided|||||||0.195527
73822235|NCT03365934|147190924|SUPERIORITY|||||||0.070843|||||||t-test, 2 sided|||||||0.070843
73822236|NCT03365934|147190924|SUPERIORITY|||||||0.997565|||||||t-test, 2 sided|||||||0.997565
73822237|NCT03365934|147190925|SUPERIORITY|||||||0.016628|||||||t-test, 2 sided|||||||0.016628
73822238|NCT03365934|147190925|SUPERIORITY|||||||0.217862|||||||t-test, 2 sided|||||||0.217862
73822239|NCT03365934|147190925|SUPERIORITY|||||||0.812915|||||||t-test, 2 sided|||||||0.812915
73822240|NCT03365934|147190925|SUPERIORITY|||||||0.999971|||||||t-test, 2 sided|||||||0.999971
73822241|NCT03365934|147190925|SUPERIORITY|||||||0.275557|||||||t-test, 2 sided|||||||0.275557
73822242|NCT03365934|147190925|SUPERIORITY|||||||0.870124|||||||t-test, 2 sided|||||||0.870124
73822243|NCT03365934|147190925|SUPERIORITY|||||||0.380144|||||||t-test, 2 sided|||||||0.380144
73822244|NCT03365934|147190925|SUPERIORITY|||||||0.029518|||||||t-test, 2 sided|||||||0.029518
73822245|NCT03365934|147190925|SUPERIORITY|||||||0.815476|||||||t-test, 2 sided|||||||0.815476
73822246|NCT03365934|147190925|SUPERIORITY|||||||0.944307|||||||t-test, 2 sided|||||||0.944307
73822247|NCT03365934|147190925|SUPERIORITY|||||||0.313389|||||||t-test, 2 sided|||||||0.313389
73822248|NCT03365934|147190925|SUPERIORITY|||||||0.999996|||||||t-test, 2 sided|||||||0.999996
73822249|NCT03365934|147190925|SUPERIORITY|||||||0.894272|||||||t-test, 2 sided|||||||0.894272
73822250|NCT03365934|147190925|SUPERIORITY|||||||0.969093|||||||t-test, 2 sided|||||||0.969093
73822251|NCT03365934|147190925|SUPERIORITY|||||||0.383434|||||||t-test, 2 sided|||||||0.383434
73822252|NCT03365934|147190926|SUPERIORITY|||||||0.393119|||||||t-test, 2 sided|||||||0.393119
73822253|NCT03365934|147190926|SUPERIORITY|||||||0.890335|||||||t-test, 2 sided|||||||0.890335
73822254|NCT03365934|147190926|SUPERIORITY|||||||0.021978|||||||t-test, 2 sided|||||||0.021978
73822255|NCT03365934|147190926|SUPERIORITY|||||||0.000983|||||||t-test, 2 sided|||||||0.000983
73822256|NCT03365934|147190926|SUPERIORITY|||||||0.006615|||||||t-test, 2 sided|||||||0.006615
73822257|NCT03365934|147190926|SUPERIORITY|||||||0.951883|||||||t-test, 2 sided|||||||0.951883
73822258|NCT03365934|147190926|SUPERIORITY|||||||0.692455|||||||t-test, 2 sided|||||||0.692455
73822259|NCT03365934|147190926|SUPERIORITY|||||||0.257254|||||||t-test, 2 sided|||||||0.257254
73822260|NCT03365934|147190926|SUPERIORITY|||||||0.530181|||||||t-test, 2 sided|||||||0.530181
73822261|NCT03365934|147190926|SUPERIORITY|||||||0.219274|||||||t-test, 2 sided|||||||0.219274
73822262|NCT03365934|147190926|SUPERIORITY|||||||0.029675|||||||t-test, 2 sided|||||||0.029675
73822263|NCT03365934|147190926|SUPERIORITY|||||||0.111454|||||||t-test, 2 sided|||||||0.111454
73822264|NCT03365934|147190926|SUPERIORITY|||||||0.995849|||||||t-test, 2 sided|||||||0.995849
73822265|NCT03365934|147190926|SUPERIORITY|||||||0.999994|||||||t-test, 2 sided|||||||0.999994
73822266|NCT03365934|147190926|SUPERIORITY|||||||0.998744|||||||t-test, 2 sided|||||||0.998744
73822267|NCT03365934|147190927|SUPERIORITY|||||||0.999858|||||||t-test, 2 sided|||||||0.999858
73822268|NCT03365934|147190927|SUPERIORITY|||||||0.215132|||||||t-test, 2 sided|||||||0.215132
73822269|NCT03365934|147190927|SUPERIORITY|||||||0.958812|||||||t-test, 2 sided|||||||0.958812
73822270|NCT03365934|147190927|SUPERIORITY|||||||0.00622|||||||t-test, 2 sided|||||||0.00622
73822271|NCT03365934|147190927|SUPERIORITY|||||||0.017733|||||||t-test, 2 sided|||||||0.017733
73822272|NCT03365934|147190927|SUPERIORITY|||||||0.330576|||||||t-test, 2 sided|||||||0.330576
73822273|NCT03365934|147190927|SUPERIORITY|||||||0.990334|||||||t-test, 2 sided|||||||0.990334
73822274|NCT03365934|147190927|SUPERIORITY|||||||0.013025|||||||t-test, 2 sided|||||||0.013025
73822275|NCT03365934|147190927|SUPERIORITY|||||||0.034707|||||||t-test, 2 sided|||||||0.034707
73822276|NCT03365934|147190927|SUPERIORITY|||||||0.771698|||||||t-test, 2 sided|||||||0.771698
73822277|NCT03365934|147190927|SUPERIORITY|||||||0.790117|||||||t-test, 2 sided|||||||0.790117
73822278|NCT03365934|147190927|SUPERIORITY|||||||0.923224|||||||t-test, 2 sided|||||||0.923224
73822279|NCT03365934|147190927|SUPERIORITY|||||||0.112245|||||||t-test, 2 sided|||||||0.112245
73822280|NCT03365934|147190927|SUPERIORITY|||||||0.216229|||||||t-test, 2 sided|||||||0.216229
73822281|NCT03365934|147190927|SUPERIORITY|||||||0.999663|||||||t-test, 2 sided|||||||0.999663
73822282|NCT03365934|147190928|SUPERIORITY|||||||0.91874|||||||t-test, 2 sided|||||||0.91874
73822283|NCT03365934|147190928|SUPERIORITY|||||||0.013582|||||||t-test, 2 sided|||||||0.013582
73822284|NCT03365934|147190928|SUPERIORITY|||||||0.523284|||||||t-test, 2 sided|||||||0.523284
73822285|NCT03365934|147190928|SUPERIORITY|||||||0.000315|||||||t-test, 2 sided|||||||0.000315
73822286|NCT03365934|147190928|SUPERIORITY|||||||0.059485|||||||t-test, 2 sided|||||||0.059485
73822287|NCT03365934|147190928|SUPERIORITY|||||||0.15037|||||||t-test, 2 sided|||||||0.15037
73822288|NCT03365934|147190928|SUPERIORITY|||||||0.967277|||||||t-test, 2 sided|||||||0.967277
73822289|NCT03365934|147190928|SUPERIORITY|||||||0.008729|||||||t-test, 2 sided|||||||0.008729
73822290|NCT03365934|147190928|SUPERIORITY|||||||0.421603|||||||t-test, 2 sided|||||||0.421603
73822291|NCT03365934|147190928|SUPERIORITY|||||||0.647267|||||||t-test, 2 sided|||||||0.647267
73822292|NCT03365934|147190928|SUPERIORITY|||||||0.953645|||||||t-test, 2 sided|||||||0.953645
73822293|NCT03365934|147190928|SUPERIORITY|||||||0.987387|||||||t-test, 2 sided|||||||0.987387
73822294|NCT03365934|147190928|SUPERIORITY|||||||0.147361|||||||t-test, 2 sided|||||||0.147361
73822295|NCT03365934|147190928|SUPERIORITY|||||||0.930371|||||||t-test, 2 sided|||||||0.930371
73822296|NCT03365934|147190928|SUPERIORITY|||||||0.6094|||||||t-test, 2 sided|||||||0.6094
73822297|NCT03365934|147190929|SUPERIORITY|||||||0.99253|||||||t-test, 2 sided|||||||0.99253
73822298|NCT03365934|147190929|SUPERIORITY|||||||0.795279|||||||t-test, 2 sided|||||||0.795279
73822299|NCT03365934|147190929|SUPERIORITY|||||||0.855067|||||||t-test, 2 sided|||||||0.855067
73822300|NCT03365934|147190929|SUPERIORITY|||||||0.003915|||||||t-test, 2 sided|||||||0.003915
73822301|NCT03365934|147190929|SUPERIORITY|||||||0.000221|||||||t-test, 2 sided|||||||0.000221
73822302|NCT03365934|147190929|SUPERIORITY|||||||0.97816|||||||t-test, 2 sided|||||||0.97816
73822303|NCT03365934|147190929|SUPERIORITY|||||||0.98972|||||||t-test, 2 sided|||||||0.98972
73822304|NCT03365934|147190929|SUPERIORITY|||||||0.01764|||||||t-test, 2 sided|||||||0.01764
73822305|NCT03365934|147190929|SUPERIORITY|||||||0.001185|||||||t-test, 2 sided|||||||0.001185
73822306|NCT03365934|147190929|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
73822307|NCT03365934|147190929|SUPERIORITY|||||||0.119961|||||||t-test, 2 sided|||||||0.119961
73822308|NCT03365934|147190929|SUPERIORITY|||||||0.013468|||||||t-test, 2 sided|||||||0.013468
73822309|NCT03365934|147190929|SUPERIORITY|||||||0.112192|||||||t-test, 2 sided|||||||0.112192
73822310|NCT03365934|147190929|SUPERIORITY|||||||0.013135|||||||t-test, 2 sided|||||||0.013135
73822311|NCT03365934|147190929|SUPERIORITY|||||||0.965966|||||||t-test, 2 sided|||||||0.965966
73822312|NCT03365934|147190930|SUPERIORITY|||||||0.968005|||||||t-test, 2 sided|||||||0.968005
73822313|NCT03365934|147190930|SUPERIORITY|||||||0.526293|||||||t-test, 2 sided|||||||0.526293
73822314|NCT03365934|147190930|SUPERIORITY|||||||0.994384|||||||t-test, 2 sided|||||||0.994384
73822315|NCT03365934|147190930|SUPERIORITY|||||||0.004967|||||||t-test, 2 sided|||||||0.004967
73822316|NCT03365934|147190930|SUPERIORITY|||||||0.000948|||||||t-test, 2 sided|||||||0.000948
73822317|NCT03365934|147190930|SUPERIORITY|||||||0.936394|||||||t-test, 2 sided|||||||0.936394
73822318|NCT03365934|147190930|SUPERIORITY|||||||0.999945|||||||t-test, 2 sided|||||||0.999945
73822319|NCT03365934|147190930|SUPERIORITY|||||||0.050032|||||||t-test, 2 sided|||||||0.050032
73822320|NCT03365934|147190930|SUPERIORITY|||||||0.01256|||||||t-test, 2 sided|||||||0.01256
73822321|NCT03365934|147190930|SUPERIORITY|||||||0.886978|||||||t-test, 2 sided|||||||0.886978
73822322|NCT03365934|147190930|SUPERIORITY|||||||0.391295|||||||t-test, 2 sided|||||||0.391295
73822323|NCT03365934|147190930|SUPERIORITY|||||||0.163678|||||||t-test, 2 sided|||||||0.163678
73822324|NCT03365934|147190930|SUPERIORITY|||||||0.047937|||||||t-test, 2 sided|||||||0.047937
73822325|NCT03365934|147190930|SUPERIORITY|||||||0.013231|||||||t-test, 2 sided|||||||0.013231
73822326|NCT03365934|147190930|SUPERIORITY|||||||0.996358|||||||t-test, 2 sided|||||||0.996358
73822327|NCT03365934|147190931|SUPERIORITY|||||||0.995862|||||||t-test, 2 sided|||||||0.995862
73822328|NCT03365934|147190931|SUPERIORITY|||||||0.223341|||||||t-test, 2 sided|||||||0.223341
73822329|NCT03365934|147190931|SUPERIORITY|||||||0.834338|||||||t-test, 2 sided|||||||0.834338
73822330|NCT03365934|147190931|SUPERIORITY|||||||0.030267|||||||t-test, 2 sided|||||||0.030267
73822331|NCT03365934|147190931|SUPERIORITY|||||||0.00104|||||||t-test, 2 sided|||||||0.00104
73822332|NCT03365934|147190931|SUPERIORITY|||||||0.377217|||||||t-test, 2 sided|||||||0.377217
73822333|NCT03365934|147190931|SUPERIORITY|||||||0.965547|||||||t-test, 2 sided|||||||0.965547
73822334|NCT03365934|147190931|SUPERIORITY|||||||0.052284|||||||t-test, 2 sided|||||||0.052284
73822335|NCT03365934|147190931|SUPERIORITY|||||||0.001348|||||||t-test, 2 sided|||||||0.001348
73822336|NCT03365934|147190931|SUPERIORITY|||||||0.927936|||||||t-test, 2 sided|||||||0.927936
73822337|NCT03365934|147190931|SUPERIORITY|||||||0.946487|||||||t-test, 2 sided|||||||0.946487
73822338|NCT03365934|147190931|SUPERIORITY|||||||0.327918|||||||t-test, 2 sided|||||||0.327918
73822339|NCT03365934|147190931|SUPERIORITY|||||||0.475038|||||||t-test, 2 sided|||||||0.475038
73822340|NCT03365934|147190931|SUPERIORITY|||||||0.060057|||||||t-test, 2 sided|||||||0.060057
73822341|NCT03365934|147190931|SUPERIORITY|||||||0.857177|||||||t-test, 2 sided|||||||0.857177
73822342|NCT03365934|147190932|SUPERIORITY|||||||0.999997|||||||t-test, 2 sided|||||||0.999997
73822343|NCT03365934|147190932|SUPERIORITY|||||||0.938793|||||||t-test, 2 sided|||||||0.938793
73822344|NCT03365934|147190932|SUPERIORITY|||||||0.965993|||||||t-test, 2 sided|||||||0.965993
73822345|NCT03365934|147190932|SUPERIORITY|||||||0.057803|||||||t-test, 2 sided|||||||0.057803
73822346|NCT03365934|147190932|SUPERIORITY|||||||0.022816|||||||t-test, 2 sided|||||||0.022816
73822347|NCT03365934|147190932|SUPERIORITY|||||||0.945179|||||||t-test, 2 sided|||||||0.945179
73822348|NCT03365934|147190932|SUPERIORITY|||||||0.972522|||||||t-test, 2 sided|||||||0.972522
73822349|NCT03365934|147190932|SUPERIORITY|||||||0.033704|||||||t-test, 2 sided|||||||0.033704
73822350|NCT03365934|147190932|SUPERIORITY|||||||0.010747|||||||t-test, 2 sided|||||||0.010747
73822351|NCT03365934|147190932|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
73822352|NCT03365934|147190932|SUPERIORITY|||||||0.385474|||||||t-test, 2 sided|||||||0.385474
73822353|NCT03365934|147190932|SUPERIORITY|||||||0.213798|||||||t-test, 2 sided|||||||0.213798
73822354|NCT03365934|147190932|SUPERIORITY|||||||0.388682|||||||t-test, 2 sided|||||||0.388682
73822355|NCT03365934|147190932|SUPERIORITY|||||||0.22386|||||||t-test, 2 sided|||||||0.22386
73822356|NCT03365934|147190932|SUPERIORITY|||||||0.999494|||||||t-test, 2 sided|||||||0.999494
73822357|NCT03365934|147190933|SUPERIORITY|||||||0.891244|||||||t-test, 2 sided|||||||0.891244
73822358|NCT03365934|147190933|SUPERIORITY|||||||0.022659|||||||t-test, 2 sided|||||||0.022659
73822359|NCT03365934|147190933|SUPERIORITY|||||||0.693615|||||||t-test, 2 sided|||||||0.693615
73822360|NCT03365934|147190933|SUPERIORITY|||||||0.000237|||||||t-test, 2 sided|||||||0.000237
73822361|NCT03365934|147190933|SUPERIORITY|||||||5e-06|||||||t-test, 2 sided|||||||0.000005
73822362|NCT03365934|147190933|SUPERIORITY|||||||0.352008|||||||t-test, 2 sided|||||||0.352008
73822363|NCT03365934|147190933|SUPERIORITY|||||||0.998761|||||||t-test, 2 sided|||||||0.998761
73822364|NCT03365934|147190933|SUPERIORITY|||||||0.017832|||||||t-test, 2 sided|||||||0.017832
73822365|NCT03365934|147190933|SUPERIORITY|||||||0.000974|||||||t-test, 2 sided|||||||0.000974
73822366|NCT03365934|147190933|SUPERIORITY|||||||0.638238|||||||t-test, 2 sided|||||||0.638238
73822367|NCT03365934|147190933|SUPERIORITY|||||||0.777423|||||||t-test, 2 sided|||||||0.777423
73822368|NCT03365934|147190933|SUPERIORITY|||||||0.249909|||||||t-test, 2 sided|||||||0.249909
73822369|NCT03365934|147190933|SUPERIORITY|||||||0.068196|||||||t-test, 2 sided|||||||0.068196
73822370|NCT03365934|147190933|SUPERIORITY|||||||0.005786|||||||t-test, 2 sided|||||||0.005786
73822371|NCT03365934|147190933|SUPERIORITY|||||||0.954163|||||||t-test, 2 sided|||||||0.954163
73822372|NCT03365934|147190935|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.851||0.009|TWO_SIDED|95.0|-13.1279|-1.8688|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1||-1.8688|-13.1279|0.009
73822373|NCT03365934|147190935|SUPERIORITY||Mean Difference (Net)|-5.08|STANDARD_ERROR_OF_MEAN|2.851||0.077|TWO_SIDED|95.0|-10.7083|0.5508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1||0.5508|-10.7083|0.077
73822374|NCT03365934|147190935|SUPERIORITY||Mean Difference (Net)|-2.41|STANDARD_ERROR_OF_MEAN|2.851||0.399|TWO_SIDED|95.0|-8.0399|3.2192|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1||3.2192|-8.0399|0.399
73822375|NCT03365934|147190935|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|2.851||0.802|TWO_SIDED|95.0|-4.9144|6.3446|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1||6.3446|-4.9144|0.802
73822376|NCT03365934|147190936|SUPERIORITY||Mean Difference (Net)|-11.37|STANDARD_ERROR_OF_MEAN|3.038|<|0.001|TWO_SIDED|95.0|-17.3738|-5.3723|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2||-5.3723|-17.3738|<0.001
73822377|NCT03365934|147190936|SUPERIORITY||Mean Difference (Net)|-12.68|STANDARD_ERROR_OF_MEAN|3.038|<|0.001|TWO_SIDED|95.0|-18.6789|-6.6775|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2||-6.6775|-18.6789|<0.001
73822378|NCT03365934|147190936|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|3.038||0.521|TWO_SIDED|95.0|-7.9571|4.0444|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2||4.0444|-7.9571|0.521
73822379|NCT03365934|147190936|SUPERIORITY||Mean Difference (Net)|8.39|STANDARD_ERROR_OF_MEAN|3.038||0.006|TWO_SIDED|95.0|2.3925|14.394|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2||14.3940|2.3925|0.006
73822380|NCT03365934|147190937|SUPERIORITY||Mean Difference (Net)|-31.83|STANDARD_ERROR_OF_MEAN|4.847|<|0.001|TWO_SIDED|95.0|-41.3967|-22.2538|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3||-22.2538|-41.3967|<0.001
73822381|NCT03365934|147190937|SUPERIORITY||Mean Difference (Net)|-27.3|STANDARD_ERROR_OF_MEAN|4.847|<|0.001|TWO_SIDED|95.0|-36.8727|-17.7298|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3||-17.7298|-36.8727|<0.001
73822382|NCT03365934|147190937|SUPERIORITY||Mean Difference (Net)|-13.71|STANDARD_ERROR_OF_MEAN|4.847||0.005|TWO_SIDED|95.0|-23.2784|-4.1355|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3||-4.1355|-23.2784|0.005
73822383|NCT03365934|147190937|SUPERIORITY||Mean Difference (Net)|10.07|STANDARD_ERROR_OF_MEAN|4.847||0.039|TWO_SIDED|95.0|0.4969|19.6398|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3||19.6398|0.4969|0.039
73822384|NCT03365934|147190938|SUPERIORITY||Mean Difference (Net)|-40.39|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-51.0324|-29.7496|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4||-29.7496|-51.0324|<0.001
73822385|NCT03365934|147190938|SUPERIORITY||Mean Difference (Net)|-37.84|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-48.4787|-27.1959|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4||-27.1959|-48.4787|<0.001
73822386|NCT03365934|147190938|SUPERIORITY||Mean Difference (Net)|-20.99|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-31.6336|-10.3508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4||-10.3508|-31.6336|<0.001
73822387|NCT03365934|147190938|SUPERIORITY||Mean Difference (Net)|8.75|STANDARD_ERROR_OF_MEAN|5.39||0.106|TWO_SIDED|95.0|-1.8871|19.3957|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4||19.3957|-1.8871|0.106
73822388|NCT03365934|147190939|SUPERIORITY||Mean Difference (Net)|-32.9|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-43.3249|-22.4838|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5||-22.4838|-43.3249|<0.001
73822389|NCT03365934|147190939|SUPERIORITY||Mean Difference (Net)|-27.31|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-37.7279|-16.8868|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5||-16.8868|-37.7279|<0.001
73822390|NCT03365934|147190939|SUPERIORITY||Mean Difference (Net)|-18.76|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-29.1785|-8.3374|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5||-8.3374|-29.1785|<0.001
73822391|NCT03365934|147190939|SUPERIORITY||Mean Difference (Net)|6.79|STANDARD_ERROR_OF_MEAN|5.276||0.2|TWO_SIDED|95.0|-3.6303|17.2107|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5||17.2107|-3.6303|0.200
73822392|NCT03365934|147190940|SUPERIORITY||Mean Difference (Net)|-30.9|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-39.5325|-22.265|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6||-22.2650|-39.5325|<0.001
73822393|NCT03365934|147190940|SUPERIORITY||Mean Difference (Net)|-25.33|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-33.9669|-16.6993|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6||-16.6993|-33.9669|<0.001
73822394|NCT03365934|147190940|SUPERIORITY||Mean Difference (Net)|-20.63|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-29.2588|-11.9912|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6||-11.9912|-29.2588|<0.001
73822395|NCT03365934|147190940|SUPERIORITY||Mean Difference (Net)|4.27|STANDARD_ERROR_OF_MEAN|4.371||0.33|TWO_SIDED|95.0|-4.362|12.9055|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6||12.9055|-4.3620|0.330
73822396|NCT03365934|147190941|SUPERIORITY||Mean Difference (Net)|-13.95|STANDARD_ERROR_OF_MEAN|3.754|<|0.001|TWO_SIDED|95.0|-21.368|-6.5419|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7||-6.5419|-21.3680|<0.001
73822397|NCT03365934|147190941|SUPERIORITY||Mean Difference (Net)|-11.54|STANDARD_ERROR_OF_MEAN|3.754||0.002|TWO_SIDED|95.0|-18.9563|-4.1302|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7||-4.1302|-18.9563|0.002
73822398|NCT03365934|147190941|SUPERIORITY||Mean Difference (Net)|-10.07|STANDARD_ERROR_OF_MEAN|3.754||0.008|TWO_SIDED|95.0|-17.4867|-2.6606|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7||-2.6606|-17.4867|0.008
73822399|NCT03365934|147190941|SUPERIORITY||Mean Difference (Net)|6.87|STANDARD_ERROR_OF_MEAN|3.754||0.069|TWO_SIDED|95.0|-0.5447|14.2814|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7||14.2814|-0.5447|0.069
73822400|NCT03365934|147190942|SUPERIORITY||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|3.244||0.397|TWO_SIDED|95.0|-9.1631|3.6504|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14||3.6504|-9.1631|0.397
73822401|NCT03365934|147190942|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|3.244||0.804|TWO_SIDED|95.0|-5.6006|7.2129|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14||7.2129|-5.6006|0.804
73822402|NCT03365934|147190942|SUPERIORITY||Mean Difference (Net)|-9.32|STANDARD_ERROR_OF_MEAN|3.244||0.005|TWO_SIDED|95.0|-15.7231|-2.9096|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14||-2.9096|-15.7231|0.005
73822403|NCT03365934|147190942|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|3.244||0.985|TWO_SIDED|95.0|-6.3452|6.4683|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14||6.4683|-6.3452|0.985
73822404|NCT03365934|147190944|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.044||0.348|TWO_SIDED|95.0|-0.129|0.0458|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1||0.0458|-0.1290|0.348
73822405|NCT03365934|147190944|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.044||0.019|TWO_SIDED|95.0|-0.1904|-0.0178|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1||-0.0178|-0.1904|0.019
73822406|NCT03365934|147190944|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.043||0.183|TWO_SIDED|95.0|-0.1437|0.0278|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1||0.0278|-0.1437|0.183
73822407|NCT03365934|147190944|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.044||0.736|TWO_SIDED|95.0|-0.0725|0.1023|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1||0.1023|-0.0725|0.736
73822408|NCT03365934|147190945|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.052||0.516|TWO_SIDED|95.0|-0.136|0.0687|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2||0.0687|-0.1360|0.516
73822409|NCT03365934|147190945|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.052||0.006|TWO_SIDED|95.0|-0.2459|-0.0412|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2||-0.0412|-0.2459|0.006
73822410|NCT03365934|147190945|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.671|TWO_SIDED|95.0|-0.1235|0.0798|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2||0.0798|-0.1235|0.671
73822411|NCT03365934|147190945|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.052||0.004|TWO_SIDED|95.0|0.0504|0.2578|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2||0.2578|0.0504|0.004
73822412|NCT03365934|147190946|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.062||0.292|TWO_SIDED|95.0|-0.1896|0.0579|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3||0.0579|-0.1896|0.292
73822413|NCT03365934|147190946|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.062||0.016|TWO_SIDED|95.0|-0.2773|-0.0297|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3||-0.0297|-0.2773|0.016
73822414|NCT03365934|147190946|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.062||0.538|TWO_SIDED|95.0|-0.1622|0.0853|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3||0.0853|-0.1622|0.538
73822415|NCT03365934|147190946|SUPERIORITY||Mean Difference (Net)|0.012|STANDARD_ERROR_OF_MEAN|0.065||0.061|TWO_SIDED|95.0|-0.0059|0.2515|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3||0.2515|-0.0059|0.061
73822416|NCT03365934|147190947|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.3265|-0.0895|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4||-0.0895|-0.3265|0.001
73822417|NCT03365934|147190947|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.3614|-0.1243|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4||-0.1243|-0.3614|<0.001
73822418|NCT03365934|147190947|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED|95.0|-0.1899|0.0471|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4||0.0471|-0.1899|0.236
73822419|NCT03365934|147190947|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.061||0.627|TWO_SIDED|95.0|-0.0902|0.1492|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4||0.1492|-0.0902|0.627
73822420|NCT03365934|147190948|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|TWO_SIDED|95.0|-0.3331|-0.1305|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5||-0.1305|-0.3331|<0.001
73822421|NCT03365934|147190948|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3091|-0.1092|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5||-0.1092|-0.3091|<0.001
73822422|NCT03365934|147190948|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.005|TWO_SIDED|95.0|-0.2439|-0.0457|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5||-0.0457|-0.2439|0.005
73822423|NCT03365934|147190948|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.052||0.02|TWO_SIDED|95.0|0.0197|0.2252|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5||0.2252|0.0197|0.020
73822424|NCT03365934|147190949|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.4019|-0.2044|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6||-0.2044|-0.4019|<0.001
73822425|NCT03365934|147190949|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3655|-0.1679|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6||-0.1679|-0.3655|<0.001
73822426|NCT03365934|147190949|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3338|-0.1377|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6||-0.1377|-0.3338|<0.001
73822427|NCT03365934|147190949|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.646|TWO_SIDED|95.0|-0.0767|0.1231|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6||0.1231|-0.0767|0.646
73822428|NCT03365934|147190950|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.047||0.006|TWO_SIDED|95.0|-0.2254|-0.0384|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7||-0.0384|-0.2254|0.006
73822429|NCT03365934|147190950|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.047||0.002|TWO_SIDED|95.0|-0.2444|-0.0574|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7||-0.0574|-0.2444|0.002
73822430|NCT03365934|147190950|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.047||0.001|TWO_SIDED|95.0|-0.2541|-0.0682|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7||-0.0682|-0.2541|0.001
73822431|NCT03365934|147190950|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.048||0.911|TWO_SIDED|95.0|-0.0891|0.0998|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7||0.0998|-0.0891|0.911
73822432|NCT03365934|147190951|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.937|TWO_SIDED|95.0|-0.0818|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14||0.0755|-0.0818|0.937
73822433|NCT03365934|147190951|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.039||0.026|TWO_SIDED|95.0|-0.1663|-0.0108|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14||-0.0108|-0.1663|0.026
73822434|NCT03365934|147190951|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.039||0.045|TWO_SIDED|95.0|-0.1562|-0.0017|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14||-0.0017|-0.1562|0.045
73822435|NCT03365934|147190951|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.039||0.956|TWO_SIDED|95.0|-0.0799|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14||0.0755|-0.0799|0.956
73822436|NCT02121795|147190973|NON_INFERIORITY|Noninferiority was assessed using a conventional 95.002% confidence interval (CI) approach, with a noninferiority margin of 10%.|Percentage difference|1.3||||0.5|TWO_SIDED|95.002|-2.5|5.1|||Cochran-Mantel-Haenszel|P-value was from Cochran-Mantel-Haenszel (CMH) test stratified by third agent.|Difference in percentages of virologic success between treatment groups and its 95.002% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by the third agent stratum.|||5.1|-2.5|0.5
73822437|NCT04391179|147190997|SUPERIORITY||Slope|-0.033|STANDARD_ERROR_OF_MEAN|0.027||0.24|TWO_SIDED|95.0|-0.089|0.023|||Mixed Models Analysis||Estimation represents log-scale difference between average daily change in D-Dimer for Dipyridamole patients minus placebo average daily change. Negative estimates indicate that D-Dimer levels decline faster in Dipyridamole versus placebo patients.|||.023|-.089|0.24
73822438|NCT04391179|147190998|SUPERIORITY||win ratio|1.0||||0.98|TWO_SIDED|97.8|0.78|1.29|||Mantel Haenszel||win ratio= (the probability of a win for the dipyridamole patient)/(probability of a win for the placebo patient)|A win ratio analysis of the hierarchical composite outcome requiring direct comparison of outcomes between each dipyridamole patient and placebo patient. The patient with the superior outcome is adjudicated the 'winner' and receives a +1 score, while the 'loser' scores -1.||1.29|0.78|.98
73822439|NCT04391179|147190999|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
73822440|NCT04391179|147191000|SUPERIORITY|||||||0.09|||||||Log Rank|||||||.09
73822441|NCT04391179|147191001|SUPERIORITY||Mean Difference (Net)|0.29||||0.36|TWO_SIDED|95.0|0.02|3.94|||regression, negative binomial||estimated ratio of days on mechanical ventilation for dipyridamole and placebo|||3.94|0.02|0.36
73822442|NCT04391179|147191002|SUPERIORITY||Odds Ratio (OR)|1.04||||0.94|TWO_SIDED|95.0|0.43|2.51|||Regression, Logistic||Odds of a 50 point drop in the dipyridamole group relative to the placebo group.|||2.51|0.43|.94
73822443|NCT04391179|147191003|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||.95
73822444|NCT00105989|147191033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustments were made for multiple comparisons. The primary efficacy analysis compared the time to recurrence during the maintenance phase between all duloxetine and placebo patients using the log-rank test, stratified by country at α=.05.|Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.||A total of 257 randomized patients (randomly assigned with equal probability to the two treatment groups) were needed to have 90% power to detect 40% versus 20% recurrence rates over 52 weeks, using a log rank test at a two-sided significance level of .05.||||<0.001
73822445|NCT00105989|147191034|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Frequencies are analyzed using Cochran-Mantel-Haenszel controlling for investigator||||||<0.001
73822446|NCT00105989|147191035|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.||||||0.003
73822447|NCT00105989|147191036|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Cochran-Mantel-Haenszel|Frequencies were analyzed using Cochran-Mantel-Haenszel controlling for investigator.||||||0.003
73822448|NCT00105989|147191037|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822449|NCT00105989|147191037|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.016
73822450|NCT00105989|147191038|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73822451|NCT00105989|147191039|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822452|NCT00105989|147191039|SUPERIORITY_OR_OTHER|||||||0.153||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.153
73822453|NCT00105989|147191040|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73822454|NCT00105989|147191041|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.||||||<0.001
73822455|NCT00105989|147191041|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.||||||<0.001
73822456|NCT00105989|147191042|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73822457|NCT00105989|147191043|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for Change from Baseline to Endpoint for all Subscales during Acute phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822458|NCT00105989|147191043|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value for Anxiety Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.334
73822459|NCT00105989|147191043|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Core Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.019
73822460|NCT00105989|147191043|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Maier Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.046
73822461|NCT00105989|147191043|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Retardation Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822462|NCT00105989|147191043|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value for Sleep Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.319
73822463|NCT00105989|147191043|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Depressed Mood Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.275
73822464|NCT00105989|147191044|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pairwise comparison of Least Squares Means for Anxiety Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||<0.001
73822465|NCT00105989|147191044|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pairwise comparison of Least Squares Means for Core Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.002
73822466|NCT00105989|147191044|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pairwise comparison of Least Squares Means for Maier Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.002
73822467|NCT00105989|147191044|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Pairwise comparison of Least Squares Means for Retardation Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.003
73822468|NCT00105989|147191044|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Pairwise comparison of Least Squares Means for Sleep Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.001
73822469|NCT00105989|147191044|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Pairwise comparison of Least Squares Means for Depressed Mood Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.003
73822470|NCT00105989|147191045|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for all Change from Baseline to Endpoint measures in the Acute Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822471|NCT00105989|147191045|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.273
73822472|NCT00105989|147191045|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||P-value for Headache Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.968
73822473|NCT00105989|147191045|SUPERIORITY_OR_OTHER|||||||0.998||95.0||||P-value for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.998
73822474|NCT00105989|147191045|SUPERIORITY_OR_OTHER|||||||0.703||95.0||||P-value for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.703
73822475|NCT00105989|147191045|SUPERIORITY_OR_OTHER|||||||0.346||95.0||||P-value for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.346
73822476|NCT00105989|147191045|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.963
73822477|NCT00105989|147191046|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-value for pairwise comparison of Least Squares Means for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.792
73822478|NCT00105989|147191046|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||P-value for pairwise comparison of Least Squares Means for Headache Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.407
73822479|NCT00105989|147191046|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||P-value for pairwise comparison of Least Squares Means for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.475
73822480|NCT00105989|147191046|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value for pairwise comparison of Least Squares Means for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.241
73822481|NCT00105989|147191046|SUPERIORITY_OR_OTHER|||||||0.885||95.0||||P-value for pairwise comparison of Least Squares Means for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.885
73822482|NCT00105989|147191046|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||P-value for pairwise comparison of Least Squares Means for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.717
73822483|NCT00105989|147191047|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822484|NCT00105989|147191047|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.157
73822485|NCT00105989|147191048|SUPERIORITY_OR_OTHER|||||||0.979||95.0|||||t-test, 2 sided|||||||0.979
73822486|NCT00105989|147191049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint in all SDS items in Acute Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822487|NCT00105989|147191049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint in all SDS items in the Continuation Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822488|NCT00105989|147191050|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Global Score|t-test, 2 sided|||||||0.029
73822489|NCT00105989|147191050|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Work/School.|t-test, 2 sided|||||||0.022
73822490|NCT00105989|147191050|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Social Life.|t-test, 2 sided|||||||0.110
73822491|NCT00105989|147191050|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Family Life/Home Responsibilities.|t-test, 2 sided|||||||0.021
73822492|NCT00105989|147191051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for Change from Baseline to Endpoint in all SF-36 subscales in the Acute Phase were \<0.001|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822493|NCT00105989|147191051|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-value for Physical Component Summary Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.947
73822494|NCT00105989|147191051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Component Summary Change to Endpoint|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822495|NCT00105989|147191051|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value for Physical Functioning Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.118
73822496|NCT00105989|147191051|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||P-value for Bodily Pain Change from Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.550
73822497|NCT00105989|147191051|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Role Limitations Due to Physical Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.029
73822498|NCT00105989|147191051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Role Limitations Due to Emotional Problems Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822499|NCT00105989|147191051|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for General Health Perceptions Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.002
73822500|NCT00105989|147191051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822501|NCT00105989|147191051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Social Function Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822502|NCT00105989|147191051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Vitality Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822503|NCT00105989|147191051|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||P-value for Rate Current Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.815
73822504|NCT00105989|147191051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Health Compared to a Year Ago Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822505|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Component Summary.|t-test, 2 sided|||||||0.415
73822506|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Component Summary.|t-test, 2 sided|||||||0.002
73822507|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.731||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Functioning.|t-test, 2 sided|||||||0.731
73822508|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Bodily Pain.|t-test, 2 sided|||||||0.438
73822509|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Physical.|t-test, 2 sided|||||||0.029
73822510|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Emotional problems.|t-test, 2 sided|||||||0.003
73822511|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-General Health Perceptions.|t-test, 2 sided|||||||0.391
73822512|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Health.|t-test, 2 sided|||||||0.001
73822513|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Social Functioning.|t-test, 2 sided|||||||0.142
73822514|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Vitality.|t-test, 2 sided|||||||0.240
73822515|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Rate General Health.|t-test, 2 sided|||||||0.615
73822516|NCT00105989|147191052|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Health Compared to a Year Ago.|t-test, 2 sided|||||||0.218
73822517|NCT00105989|147191053|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for change in number of Primary Health Care Provider Visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.838
73822518|NCT00105989|147191053|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in number of Psychiatrist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822519|NCT00105989|147191053|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||P-value for change in number of Psychologist/Therapist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.236
73822520|NCT00105989|147191053|SUPERIORITY_OR_OTHER|||||||0.145||95.0||||P-value for change in number of Other Specialist Physician visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.145
73822521|NCT00105989|147191053|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||P-value for change in number of Other (Specified by Patient) visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.423
73822522|NCT00105989|147191053|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value for change in number of Primary Health Care Provider visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.325
73822523|NCT00105989|147191053|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in number of Psychiatrist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822524|NCT00105989|147191053|SUPERIORITY_OR_OTHER|||||||0.915||95.0||||P-value for change in number of Psychologist/Therapist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.915
73822525|NCT00105989|147191053|SUPERIORITY_OR_OTHER|||||||0.223||95.0||||P-value for change in number of Other Specialist Physician visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.223
73822526|NCT00105989|147191053|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||P-value for change in number of Other (Specified by Patient) visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.362
73822527|NCT00105989|147191054|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Primary Health Care Provider visits.|t-test, 2 sided|||||||0.462
73822528|NCT00105989|147191054|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychiatrist visits.|t-test, 2 sided|||||||0.668
73822529|NCT00105989|147191054|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychologist/Therapist visits.|t-test, 2 sided|||||||0.746
73822530|NCT00105989|147191054|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Other Specialist Physician visits.|t-test, 2 sided|||||||0.511
73822531|NCT00105989|147191054|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Other (Specified by Patient) Provider visits.|t-test, 2 sided|||||||0.271
73822532|NCT00105989|147191055|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||P-value for Change in Average Number of Hours Worked In a Week in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.506
73822533|NCT00105989|147191055|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||P-value for Change in Average Number of Hours Worked In a Week in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.057
73822534|NCT00105989|147191056|SUPERIORITY_OR_OTHER|||||||0.826||95.0|||||t-test, 2 sided|||||||0.826
73822535|NCT00105989|147191057|SUPERIORITY_OR_OTHER|||||||0.105||95.0||||P-value for Change in Number of Missed Paid Work Hours in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.105
73822536|NCT00105989|147191057|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value for Change in Number of Missed Paid Work Hours in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.174
73822537|NCT00105989|147191058|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||t-test, 2 sided|||||||0.037
73822538|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.785
73822539|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.354
73822540|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.170
73822541|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.825||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.825
73822542|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.877||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.877
73822543|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.009
73822544|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.670
73822545|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.100
73822546|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.021
73822547|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.047
73822548|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.023
73822549|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.668
73822550|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.136||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.136
73822551|NCT00105989|147191059|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.152
73822552|NCT00105989|147191060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822553|NCT00105989|147191060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822554|NCT00105989|147191060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822555|NCT00105989|147191060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822556|NCT00105989|147191060|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.005
73822557|NCT00105989|147191060|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.050
73822558|NCT00105989|147191060|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.022
73822559|NCT00105989|147191060|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.002
73822560|NCT00105989|147191060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822561|NCT00105989|147191060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822562|NCT00105989|147191060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822563|NCT00105989|147191060|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.186
73822564|NCT00105989|147191060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822565|NCT00105989|147191060|SUPERIORITY_OR_OTHER|||||||0.308||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.308
73822566|NCT00105989|147191061|SUPERIORITY_OR_OTHER|||||||0.773||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided|||||||0.773
73822567|NCT00105989|147191061|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided|||||||0.405
73822568|NCT00105989|147191061|SUPERIORITY_OR_OTHER|||||||0.443||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided|||||||0.443
73822569|NCT00105989|147191061|SUPERIORITY_OR_OTHER|||||||0.384||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided|||||||0.384
73822570|NCT00105989|147191061|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided|||||||0.268
73822571|NCT00105989|147191061|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided|||||||0.093
73822572|NCT00105989|147191061|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided|||||||0.566
73822573|NCT00105989|147191062|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided|||||||0.979
73822574|NCT00105989|147191062|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided|||||||0.132
73822575|NCT00105989|147191062|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided|||||||0.180
73822576|NCT00105989|147191062|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided|||||||0.163
73822577|NCT00105989|147191062|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided|||||||0.844
73822578|NCT00105989|147191062|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided|||||||0.609
73822579|NCT00105989|147191062|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided|||||||0.071
73822580|NCT00105989|147191063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822581|NCT00105989|147191063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822582|NCT00105989|147191064|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||t-test, 2 sided|||||||0.314
73822583|NCT00105989|147191065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822584|NCT00105989|147191065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
73822585|NCT00105989|147191066|SUPERIORITY_OR_OTHER|||||||0.891||95.0|||||t-test, 2 sided|||||||0.891
73822586|NCT00105989|147191067|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.659
73822587|NCT00105989|147191067|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.064
73822588|NCT00105989|147191067|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.224
73822589|NCT00105989|147191067|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.210
73822590|NCT00105989|147191068|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value for Change from Baseline: systolic blood pressure.|t-test, 2 sided|||||||0.134
73822591|NCT00105989|147191068|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||P-value for Change from Baseline: diastolic blood pressure.|t-test, 2 sided|||||||0.816
73822592|NCT00105989|147191069|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
73822593|NCT00105989|147191070|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.007
73822594|NCT00105989|147191071|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.035
73822595|NCT00105989|147191072|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.021
73822596|NCT00105989|147191073|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
73822597|NCT00105989|147191074|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.019
73822598|NCT00105989|147191075|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.005
73822599|NCT00105989|147191076|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.031
73822600|NCT00105989|147191077|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
73822601|NCT00105989|147191078|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
73822602|NCT00105989|147191079|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
73822603|NCT00105989|147191080|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
73822604|NCT00105989|147191081|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
73822605|NCT00105989|147191082|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.004
73822606|NCT00105989|147191083|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.010
73822607|NCT00105989|147191084|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.003
73822608|NCT00105989|147191085|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
73822609|NCT00105989|147191086|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.015
73822610|NCT00105989|147191087|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.021
73822611|NCT00105989|147191088|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
73822612|NCT00105989|147191089|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.032
73822613|NCT00105989|147191090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
73822614|NCT00105989|147191091|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
73822615|NCT00105989|147191092|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.028
73822616|NCT00105989|147191093|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.008
73822617|NCT00105989|147191094|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.046
73822618|NCT00105989|147191095|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.035
73822619|NCT00105989|147191096|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.011
73822620|NCT00105989|147191097|SUPERIORITY_OR_OTHER|||||||0.744||95.0||||P-value for fasting glucose change from baseline to endpoint|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.744
73822621|NCT00105989|147191097|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for non-fasting glucose change from baseline to endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.030
73822622|NCT03442088|147191100|OTHER||Mean Difference (Final Values)|-0.272||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
73822623|NCT03442088|147191101|OTHER||Mean Difference (Final Values)|95.98||||0.934|TWO_SIDED|95.0|-2324.0|2516.0|||t-test, 2 sided|||||2516|-2324|0.934
73822624|NCT03442088|147191102|OTHER||Mean Difference (Final Values)|-0.6878||||0.1632|TWO_SIDED|95.0|-1.685|0.3097|||t-test, 2 sided|||||0.3097|-1.685|0.1632
73822625|NCT03442088|147191103|OTHER||Mean Difference (Final Values)|-2.344||||0.1063|TWO_SIDED|95.0|-5.248|0.5992|||t-test, 2 sided|||||0.5992|-5.248|0.1063
73822626|NCT03442088|147191104|OTHER||Mean Difference (Final Values)|3.24||||0.5611|TWO_SIDED|95.0|-8.333|14.81|||t-test, 2 sided|||||14.81|-8.333|0.5611
73822627|NCT00357877|147191109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.44||0.56|TWO_SIDED|95.0|-0.6|1.11||No interim analyses were done and no adjustment made for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALZE to obtain final p-values.|Regression, Linear|The primary outcome analysis included treatment and site as class variables and age and age-squared as continuous covariates.||We hypothesized a lower increment score for the active treatment group but carried out two-tailed hypothesis testing. Sample size was estimated with simulated data with rank normalized scores. We calculated that 832 participants would yield a power of 90% to detect a 20% reduction in caries incidence (from a hypothesized mean increment of 1.5), and adopted a target of 1000 randomized participants to allow for attrition.||1.11|-0.60|0.56
73822628|NCT00357877|147191110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.57||0.54|TWO_SIDED|95.0|-0.77|1.46||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables and age and age-squared as continuous covariates.||hypothesized a reduced caries increment in active arm, though conducted two-tailed hypothesis test.||1.46|-0.77|0.54
73822629|NCT00357877|147191111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.38||0.18|TWO_SIDED|95.0|-1.25|0.23||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|treatment and site included as class variables and age and age-squared as continuous covariates.||Hypothesized lower increment in active arm, though hypothesis testing was two-sided.||0.23|-1.25|0.18
73822630|NCT00357877|147191112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_DEVIATION|0.57||0.24|TWO_SIDED|95.0|-1.8|0.45||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables, and age and age-squared as continuous covariates.||Hypothesized a lower increment for active treatment arm, although hypothesis testing was two-sided.||0.45|-1.80|0.24
73822631|NCT03570047|147191136|OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.558|0.766|||Cox proportional hazards model|||||0.766|0.558|<0.0001
73822632|NCT03570047|147191136|OTHER||Hazard Ratio (HR)|0.79||||0.0291|TWO_SIDED|95.0|0.642|0.977|||Cox proportional hazards model|||||0.977|0.642|0.0291
73822633|NCT03570047|147191136|OTHER||Hazard Ratio (HR)|0.71||||0.0001|TWO_SIDED|95.0|0.592|0.842|||Cox proportional hazards model|||||0.842|0.592|0.0001
73822634|NCT03570047|147191136|OTHER||Hazard Ratio (HR)|0.72||||0.0012|TWO_SIDED|95.0|0.591|0.879|||Cox proportional hazards model|||||0.879|0.591|0.0012
73822635|NCT03570047|147191137|OTHER||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.614|0.843|||Cox proportional hazards model|||||0.843|0.614|<0.0001
73822636|NCT03570047|147191137|OTHER||Hazard Ratio (HR)|0.66||||0.0003|TWO_SIDED|95.0|0.529|0.825|||Cox proportional hazards model|||||0.825|0.529|0.0003
73822637|NCT03570047|147191137|OTHER||Hazard Ratio (HR)|0.74||||0.0007|TWO_SIDED|95.0|0.618|0.879|||Cox proportional hazards model|||||0.879|0.618|0.0007
73822638|NCT03570047|147191137|OTHER||Hazard Ratio (HR)|0.71||||0.0011|TWO_SIDED|95.0|0.583|0.874|||Cox proportional hazards model|||||0.874|0.583|0.0011
73822639|NCT03570047|147191138|OTHER||Hazard Ratio (HR)|0.93||||0.0127|TWO_SIDED|95.0|0.872|0.984|||Cox proportional hazards model|||||0.984|0.872|0.0127
73822640|NCT03570047|147191138|OTHER||Hazard Ratio (HR)|0.96||||0.2893||95.0|0.881|1.039|||Cox proportional hazards model|||||1.039|0.881|0.2893
73822641|NCT03570047|147191138|OTHER||Hazard Ratio (HR)|0.94||||0.064|TWO_SIDED|95.0|0.881|1.004|||Cox proportional hazards model|||||1.004|0.881|0.0640
73822642|NCT03570047|147191138|OTHER||Hazard Ratio (HR)|1.03||||0.4404|TWO_SIDED|95.0|0.958|1.103|||Cox proportional hazards model|||||1.103|0.958|0.4404
73822643|NCT00411450|147191202|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-11.0|21.0|||||Difference = Wild type - Mutant|Difference at Week 17||21|-11|
73822644|NCT00411450|147191202|SUPERIORITY_OR_OTHER||Difference|8.0|||||TWO_SIDED|95.0|-9.0|23.0||||||Difference at Week 25||23|-9|
73822645|NCT00411450|147191204|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|95.0|-11.0|23.0|||||Difference = Wild type - Mutant|||23|-11|
73822646|NCT00411450|147191205|SUPERIORITY_OR_OTHER||Difference|12.5|||||TWO_SIDED|95.0|-6.3|31.4|||||Difference = Wild type - Mutant|Difference at Week 17||31.4|-6.3|
73822647|NCT00411450|147191205|SUPERIORITY_OR_OTHER||Difference|10.9|||||TWO_SIDED|95.0|-8.4|30.2||||||Difference at Week 25||30.2|-8.4|
73822648|NCT00411450|147191206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.1|0.5|
73822649|NCT00411450|147191207|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-14.0|25.0|||||Difference = Wild type - Mutant|Difference at Week 17||25|-14|
73822650|NCT00411450|147191207|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-14.0|25.0||||||Difference at Week 25||25|-14|
73822651|NCT00411450|147191208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||2.0|0.2|
73822652|NCT00411450|147191209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.4|0.9|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||0.9|0.4|
73822653|NCT00411450|147191210|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.1|0.5|
73822654|NCT00411450|147191211|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.2|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.2|0.5|
73822655|NCT00614874|147191259|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||Comparison is between baseline and week 12|ANOVA|||||||0.048
73822656|NCT00614874|147191260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_DEVIATION|35.0||0.183||95.0||||comparison was at baseline and week 12|Friedman|||||||0.183
73822657|NCT00614874|147191261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.95||0.398||95.0||||Comparison was at baseline and week 12|Friedman|||||||0.398
73822658|NCT02427841|147191271|SUPERIORITY|Tested against the standard R0 rate of 37%. Given all evaluable patients are included in the denominator, R0 of 56% was not achieved. Specifically, of the 19 evaluable patients, 11 proceeded to surgery. Of the 11 who underwent surgery, 8 \[42% of those enrolled, but 72.7% of those resected\] achieved R0 resection.|binomial|42.0||||0.404|TWO_SIDED|95.0|20.0|67.0||Study was underpowered.|2-sided exact binomial||Test for superiority over standard R0 resection rate of 37%. Study was closed due to slow enrollment, meaning the primary endpoint was underpowered with only 19 of an expected 44 patients enrolled.|Study closed early due to lack of enrollment. Study expected to enrolled 44 evaluable patients to achieve 83% power using the 2-sided binomial test at 10% significance. Study enrolled only 19 evaluable patients, meaning the study was underpowered at \< 62%||67|20|.404
73822659|NCT01509612|147191293|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||||||0.397
73822660|NCT01509612|147191294|SUPERIORITY|||||||0.02|||||||Chi-squared|||Only those groups were compared who received an intervention||||0.02
73822661|NCT02797678|147191318|SUPERIORITY|||||||0.061|||||||paired t-test|||||||0.061
73822662|NCT02797678|147191321|SUPERIORITY|||||||0.301|||||||paired t-test|||||||0.301
73822663|NCT00656175|147191364|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon sign-rank test used for statistical significance.||||0.52
73822664|NCT02497937|147191365|OTHER||Mean Difference (Net)|0.793|||||TWO_SIDED|95.0|-0.925|2.512|||||Difference estimate of DLco on Day 7 has been presented for Mayo site|||2.512|-0.925|
73822665|NCT03790865|147191403|SUPERIORITY||Mean Difference (Net)|4.0|||<|0.025|TWO_SIDED||||||Mixed Models Analysis|||||||<0.025
73822666|NCT00534638|147191416|SUPERIORITY||Vaccine effectiveness percentage|49.6||||0.004|TWO_SIDED|95.0|20.1|68.2||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B B Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B B Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.||68.2|20.1|0.004
73822667|NCT00534638|147191416|SUPERIORITY||Vaccine effectiveness percentage|23.8||||0.232|TWO_SIDED|95.0|-19.0|51.1||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.||51.1|-19.0|0.232
73822668|NCT00534638|147191417|SUPERIORITY||Vaccine effectiveness percentage|-52.2||||0.069|TWO_SIDED|95.0|-139.4|3.3||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Cervarix/Engerix-B B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Cervarix/Engerix-B B was based on stratified Mantel-Haenszel adjusted for clustering.||3.3|-139.4|0.069
73822669|NCT00511173|147191540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|4.5|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: there is no difference in warfarin dose (mg/wk) between pharmacist dosing and algorithm dosing. In order to gather all SNP groups, the power analysis resulted in \> 100 patients enrolled into each group.||||< 0.05
73822670|NCT03569098|147191562|SUPERIORITY||Difference in LS mean|0.32|STANDARD_ERROR_OF_MEAN|0.441||0.7669|TWO_SIDED|95.0|-0.55|1.19||One-sided P-value. The model includes the fixed categorical effects of treatment group, visit, treatment group-by-visit interaction, and the stratification factor as fixed categorical covariates and the Baseline value as a fixed continuous covariate.|Mixed Model for Repeated Measures (MMRM)|||Dysport 300 U versus Placebo.||1.19|-0.55|0.7669
73822671|NCT03569098|147191562|SUPERIORITY||Difference in LS mean|-0.36|STANDARD_ERROR_OF_MEAN|0.444||0.2085|TWO_SIDED|95.0|-1.24|0.51||One-sided P-value. The model includes the fixed categorical effects of treatment group, visit, treatment group-by-visit interaction, and the stratification factor as fixed categorical covariates and the Baseline value as a fixed continuous covariate.|MMRM|||Dysport 500 U versus Placebo.||0.51|-1.24|0.2085
73822672|NCT00758498|147191576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|||<|0.0001|TWO_SIDED|95.0|2.07|3.71|||ANCOVA|Treatment was a factor and baseline value was a co-variate||||3.71|2.07|<0.0001
73822673|NCT00758498|147191576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9|||<|0.0001|TWO_SIDED|95.0|6.06|7.69|||ANCOVA|Treatment was a factor and baseline value was a co-variate||||7.69|6.06|<0.0001
73822674|NCT00758498|147191577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8341|TWO_SIDED|95.0|-0.2|0.25|||ANOVA|||||0.25|-0.20|0.8341
73822675|NCT00758498|147191577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0441|TWO_SIDED|95.0|-0.5|-0.05|||ANCOVA|||||-0.05|-0.50|0.0441
73822676|NCT00758498|147191578|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73822677|NCT00758498|147191578|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73822678|NCT00758498|147191579|SUPERIORITY_OR_OTHER|||||||0.0012|||||||ANCOVA|Treatment comparisons made use of an analysis of covariance (ANCOVA) analysis with treatment as a factor and baseline value as a covariate||||||0.0012
73822679|NCT00758498|147191579|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis by ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
73822680|NCT00758498|147191580|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Analysis of treatment comparisons is based on an analysis of variance (ANCOVA) with treatment as a factor and the baseline value as covariate|ANCOVA|||||||<0.0001
73822681|NCT00758498|147191580|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on an ANCOVA with treatment as a factor and baseline value as a covariate||||||<0.0001
73822682|NCT00758498|147191581|SUPERIORITY_OR_OTHER|||||||0.0022|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate||||||0.0022
73822683|NCT00758498|147191581|SUPERIORITY_OR_OTHER|||||||0.0033|||||||ANCOVA|Analysis of treatment comparisons was based on ANCOVA with treatment as a factor and the baseline as a covariate||||||0.0033
73822684|NCT00758498|147191587|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as factor and baseline value as a covariate.||||||<0.0001
73822685|NCT00758498|147191587|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as factor and baseline value as a covariate||||||<0.0001
73822686|NCT00758498|147191588|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate||||||<0.0001
73822687|NCT00758498|147191588|SUPERIORITY_OR_OTHER||Least square mean||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
73822688|NCT00758498|147191589|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||||<0.0001
73822689|NCT00758498|147191589|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is from an ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
73822690|NCT00758498|147191591|SUPERIORITY_OR_OTHER|||||||0.8262|||||||ANOVA|||||||0.8262
73822691|NCT00758498|147191591|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||||||0.0040
73822692|NCT00758498|147191592|SUPERIORITY_OR_OTHER|||||||0.9595|||||||ANOVA|||||||0.9595
73822693|NCT00758498|147191592|SUPERIORITY_OR_OTHER||Least square mean|||||0.3539|||||||ANOVA|||||||0.3539
73822694|NCT00758498|147191593|SUPERIORITY_OR_OTHER|||||||0.1038|||||||ANOVA|||||||0.1038
73822695|NCT00758498|147191593|SUPERIORITY_OR_OTHER|||||||0.8112|||||||ANOVA|||||||0.8112
73822696|NCT01516736|147191617|EQUIVALENCE|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|TWO_SIDED|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~1. that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~2. that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."||0.08|-0.40|0.05
73822697|NCT01516736|147191617|NON_INFERIORITY|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|TWO_SIDED|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~1. that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~2. that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."||0.08|-0.40|0.05
73822698|NCT01781208|147191642|SUPERIORITY_OR_OTHER||||||<|0.0001||||||r=0.68, unadjusted for age, gender, and histologic inflammation.|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.||||<0.0001
73822699|NCT01781208|147191642|SUPERIORITY_OR_OTHER||||||<|0.0001||||||r=0.73, unadjusted for age, gender, and histologic inflammation score|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTIQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.||||<0.0001
73822700|NCT04194489|147191643|OTHER|Effect size calculation|Cohen's d|0.43|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
73822701|NCT04194489|147191644|OTHER|Effect size|Cohen's d|0.17|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
73822702|NCT04194489|147191645|OTHER|Effect size calculation|Cohen's d|0.27|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
73822703|NCT04194489|147191646|OTHER|Effect size calculation|Cohen's d|0.02|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
73822704|NCT00522548|147191649|SUPERIORITY|||||||0.29||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||.29
73822705|NCT00522548|147191650|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.39
73822706|NCT00522548|147191651|SUPERIORITY|||||||1||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||1.0
73822707|NCT00522548|147191652|SUPERIORITY|||||||1||||||A p value of less than 0.05 was considered significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||1.00
73822708|NCT00522548|147191653|SUPERIORITY|||||||0.14||||||a p value of less than 0.05 was considered statistically significant|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.14
73822709|NCT00522548|147191654|SUPERIORITY|||||||0.34||||||A p value of less than 0.05 was considered statistically significant.|Chi-squared|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.34
73822710|NCT00522548|147191655|SUPERIORITY_OR_OTHER|||||||0.51||||||A p-value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||.51
73822711|NCT00522548|147191656|SUPERIORITY|||||||0.95|TWO_SIDED|95.0||||A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.95
73822712|NCT00522548|147191657|SUPERIORITY|||||||0.57||||||The p value was not adjusted for multiple comparisons. A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.57
73822713|NCT00522548|147191658|SUPERIORITY|||||||0.45|TWO_SIDED|95.0||||This represents p value for week 4 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.45
73822714|NCT00522548|147191658|SUPERIORITY|||||||0.58|TWO_SIDED|95.0||||This represents p value for week 24 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.58
73822715|NCT00522548|147191659|SUPERIORITY|||||||0.012||||||This p value is for data at week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.012
73822716|NCT00522548|147191659|SUPERIORITY|||||||0.046|TWO_SIDED|95.0||||This p value was for data at week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic Group) in this proof of concept study.||||0.046
73822717|NCT00522548|147191660|SUPERIORITY|||||||0.27||||||p value represents data for week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.27
73822718|NCT00522548|147191660|SUPERIORITY|||||||0.23|TWO_SIDED|95.0||||p value represents data for week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.23
73822719|NCT01111565|147191665|SUPERIORITY||Treatment Difference|-5.4|||=|0.079|TWO_SIDED|95.0|-11.5|0.7|||ANCOVA|||||0.7|-11.5|=0.079
73822720|NCT01111565|147191665|SUPERIORITY||Treatment Difference|-5.2|||=|0.085|TWO_SIDED|95.0|-11.2|0.7|||ANCOVA|||||0.7|-11.2|=0.085
73822721|NCT01111565|147191666|SUPERIORITY||Treatment Difference|-0.5|||=|0.148|TWO_SIDED|95.0|-1.1|0.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.1|-1.1|=0.148
73822722|NCT01111565|147191666|SUPERIORITY||Treatment Difference|-0.4|||=|0.242|TWO_SIDED|95.0|-1.0|0.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.3|-1.0|=0.242
73822723|NCT01111565|147191667|SUPERIORITY||Treatment Difference|0.1|||=|0.91|TWO_SIDED|95.0|-1.8|2.1|||ANCOVA|||||2.1|-1.8|=0.910
73822724|NCT01111565|147191667|SUPERIORITY||Treatment Difference|-1.0|||=|0.291|TWO_SIDED|95.0|-3.0|0.9|||ANCOVA|||||0.9|-3.0|=0.291
73822725|NCT02683239|147191680|SUPERIORITY||Least Squares Mean|-0.73|STANDARD_ERROR_OF_MEAN|0.221|=|0.001|TWO_SIDED|95.0|-1.159|-0.293|||Mixed Models Analysis|||||-0.293|-1.159|= 0.0010
73822726|NCT02683239|147191680|SUPERIORITY||Least Squares Mean|-1.22|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|-1.646|-0.793|||Mixed Models Analysis|||||-0.793|-1.646|< 0.0001
73822727|NCT02683239|147191680|SUPERIORITY||Least Squares Mean|-1.23|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.664|-0.793|||Mixed Models Analysis|||||-0.793|-1.664|< 0.0001
73822728|NCT02683239|147191680|SUPERIORITY||Least Squares Mean|-1.04|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.477|-0.606|||Mixed Models Analysis|||||-0.606|-1.477|< 0.0001
73822729|NCT02683239|147191681|SUPERIORITY||Least Squares Mean|-0.74|STANDARD_ERROR_OF_MEAN|0.218|=|0.0007|TWO_SIDED|95.0|-1.163|-0.309|||Mixed Models Analysis|||||-0.309|-1.163|= 0.0007
73822730|NCT02683239|147191681|SUPERIORITY||Least Squares Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.218|<|0.0001|TWO_SIDED|95.0|-1.624|-0.768|||Mixed Models Analysis|||||-0.768|-1.624|< 0.0001
73822731|NCT02683239|147191681|SUPERIORITY||Least Squares Mean|-1.26|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.698|-0.822|||Mixed Models Analysis|||||-0.822|-1.698|< 0.0001
73822732|NCT02683239|147191681|SUPERIORITY||Least Squares Mean|-1.13|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.564|-0.695|||Mixed Models Analysis|||||-0.695|-1.564|< 0.0001
73822733|NCT02683239|147191682|SUPERIORITY||Least Squares Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.09|=|0.023|TWO_SIDED|95.0|-0.38|-0.028|||Mixed Models Analysis|||||-0.028|-0.380|= 0.0230
73822734|NCT02683239|147191682|SUPERIORITY||Least Squares Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.088|=|0.0025|TWO_SIDED|95.0|-0.437|-0.093|||Mixed Models Analysis|||||-0.093|-0.437|= 0.0025
73822735|NCT02683239|147191682|SUPERIORITY||Least Squares Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.09|=|0.0003|TWO_SIDED|95.0|-0.496|-0.145|||Mixed Models Analysis|||||-0.145|-0.496|= 0.0003
73822736|NCT02683239|147191682|SUPERIORITY||Least Squares Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.089|=|0.001|TWO_SIDED|95.0|-0.466|-0.118|||Mixed Models Analysis|||||-0.118|-0.466|= 0.0010
73822737|NCT00873730|147191697|SUPERIORITY_OR_OTHER|||||||0.6031|||||||Chi-squared|||||||0.6031
73822738|NCT00873730|147191698|SUPERIORITY_OR_OTHER|||||||0.9166|||||||Chi-squared|||||||0.9166
73822739|NCT00873730|147191699|SUPERIORITY_OR_OTHER|||||||0.7564|||||||Chi-squared|||||||0.7564
73822740|NCT00873730|147191700|SUPERIORITY_OR_OTHER|||||||0.3266|||||||Chi-squared|||||||0.3266
73822741|NCT00873730|147191701|SUPERIORITY_OR_OTHER|||||||0.7481|||||||Chi-squared|||||||0.7481
73822742|NCT00873730|147191702|SUPERIORITY_OR_OTHER|||||||0.7721|||||||Chi-squared|||||||0.7721
73822743|NCT00873730|147191703|SUPERIORITY_OR_OTHER|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Nocturnal Back Pain.||||0.6660
73822744|NCT00873730|147191703|SUPERIORITY_OR_OTHER|||||||0.5364|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Overall Spinal Pain.||||0.5364
73822745|NCT00873730|147191704|SUPERIORITY_OR_OTHER|||||||0.9426|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Physician Global Assessment.||||0.9426
73822746|NCT00873730|147191704|SUPERIORITY_OR_OTHER|||||||0.4969|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Patient Global Assessment.||||0.4969
73822747|NCT00873730|147191705|SUPERIORITY_OR_OTHER|||||||0.6687|||||||Wilcoxon (Mann-Whitney)|||||||0.6687
73822748|NCT00873730|147191706|SUPERIORITY_OR_OTHER|||||||0.6739|||||||Wilcoxon (Mann-Whitney)|||||||0.6739
73822749|NCT00873730|147191707|SUPERIORITY_OR_OTHER|||||||0.2772|||||||Wilcoxon (Mann-Whitney)|||||||0.2772
73822750|NCT00873730|147191708|SUPERIORITY_OR_OTHER|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.1560
73822751|NCT00873730|147191709|SUPERIORITY_OR_OTHER|||||||0.2099|||||||Chi-squared|||Analysis provided for Mobility.||||0.2099
73822752|NCT00873730|147191709|SUPERIORITY_OR_OTHER|||||||0.8009|||||||Chi-squared|||Analysis provided for Self-care.||||0.8009
73822753|NCT00873730|147191709|SUPERIORITY_OR_OTHER|||||||0.429|||||||Chi-squared|||Analysis provided for Usual activities.||||0.4290
73822754|NCT00873730|147191709|SUPERIORITY_OR_OTHER|||||||0.0461|||||||Chi-squared|||Analysis provided for Pain/Discomfort.||||0.0461
73822755|NCT00873730|147191709|SUPERIORITY_OR_OTHER|||||||0.562|||||||Chi-squared|||Analysis provided for Anxiety/Depression.||||0.5620
73822756|NCT00873730|147191710|SUPERIORITY_OR_OTHER|||||||0.3476|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical functioning.||||0.3476
73822757|NCT00873730|147191710|SUPERIORITY_OR_OTHER|||||||0.9045|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical role limitations.||||0.9045
73822758|NCT00873730|147191710|SUPERIORITY_OR_OTHER|||||||0.8558|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Bodily pain.||||0.8558
73822759|NCT00873730|147191710|SUPERIORITY_OR_OTHER|||||||0.3123|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for General health.||||0.3123
73822760|NCT00873730|147191710|SUPERIORITY_OR_OTHER|||||||0.3327|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Vitality.||||0.3327
73822761|NCT00873730|147191710|SUPERIORITY_OR_OTHER|||||||0.8334|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Social functioning.||||0.8334
73822762|NCT00873730|147191710|SUPERIORITY_OR_OTHER|||||||0.7998|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Emotional role limitations.||||0.7998
73822763|NCT00873730|147191710|SUPERIORITY_OR_OTHER|||||||0.7125|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Mental health.||||0.7125
73822764|NCT00873730|147191712|SUPERIORITY_OR_OTHER|||||||0.7404|||||||Wilcoxon (Mann-Whitney)|||||||0.7404
73822765|NCT04878055|147191724|SUPERIORITY||Odds Ratio (OR)|1.626||||0.216|TWO_SIDED|95.0|0.752|3.514|||Two-sided regression, Logistic|||Analysis is based on logistic regression model with Multiple Imputation under missing not at random using retrieve dropouts with proportion of patients alive and free of respiratory failure at Day 28 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables. Site is considered as random effects that vary randomly among patients.||3.514|0.752|0.216
73822766|NCT04878055|147191725|SUPERIORITY|||||||0.377|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||||||0.377
73822767|NCT04878055|147191726|SUPERIORITY|Analysis is based on logistic regression model with proportion of patients died up to Date 28 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables. Site is considered as random effects that vary randomly among patients.|Odds Ratio (OR)|0.468||||0.17|TWO_SIDED|95.0|0.158|1.386|||Two-sided regression, Logistic|||||1.386|0.158|0.17
73822768|NCT04878055|147191727|SUPERIORITY||Odds Ratio (OR)|0.561||||0.168|TWO_SIDED|95.0|0.247|1.277|||Regression, Logistic|||||1.277|0.247|0.168
73822769|NCT04878055|147191728|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. Estimates were calculated taking into account the following competing risks: Death, discontinuation for AEs and patient transferred to another institution.||||||0.167|||||||Gray's Test|||Until Day 28||||0.167
73822770|NCT04878055|147191729|SUPERIORITY|||||||0.55||||||Comparison between treatment arms is performed by means of a Fisher's Exact test.|Fisher Exact|||At Day 3 - please note that the number of subjects is 268 (180+88) and not 270.||||0.55
73822771|NCT04878055|147191729|SUPERIORITY|||||||0.128|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared mean.||At Day 7 - Please note that the total of subjects in this analysis is not 270 but 266 (n=179 in the Reparixin group and n=87 in the placebo group).||||0.128
73822772|NCT04878055|147191729|SUPERIORITY|||||||0.235|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 14 - Please note that the total of subjects in this analysis is not 270 but 256 (n=173 in the Reparixin group and n=83 in the placebo group).||||0.235
73822773|NCT04878055|147191729|SUPERIORITY|||||||0.281|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 21 - Please note that the total of subjects in this analysis is not 270 but 255 (n=172 in the Reparixin group and n=83 in the placebo group).||||0.281
73822774|NCT04878055|147191729|SUPERIORITY|||||||0.273|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 90 - Please note that the total of subjects in this analysis is not 270 but 50 (n=33 in the Reparixin group and n=17 in the placebo group).||||0.273
73822775|NCT04878055|147191730|SUPERIORITY|||||||0.047||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||At Day 3 - Please note that the number of subjects in this analysis is not 270 but 255||||0.047
73822776|NCT04878055|147191730|SUPERIORITY|||||||0.262|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||||||0.262
73822777|NCT04878055|147191730|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 14 - Please note that the number of subjects in this analysis is not 270 but 209||||0.367
73822778|NCT04878055|147191730|SUPERIORITY|||||||0.882||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||At Day 21 - Please note that the number of subjects in this analysis is not 270 but 176||||0.882
73822779|NCT04878055|147191730|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 28 - Please note that the number of subjects in this analysis is not 270 but 190||||0.19
73822780|NCT04878055|147191730|SUPERIORITY|||||||0.161||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||At Day 60 - Please note that the number of subjects in this analysis is not 270 but 201||||0.161
73822781|NCT04878055|147191730|SUPERIORITY|||||||0.853|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 90 - Please note that the number of subjects in this analysis is not 270 but 18||||0.853
73822782|NCT04878055|147191730|SUPERIORITY|||||||0.068|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At EOS - Please note that the number of subjects in this analysis is not 270 but 229||||0.068
73822783|NCT04878055|147191730|SUPERIORITY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At hospital discharge (HD) - Please note that the number of subjects in this analysis is not 270 but 195||||0.672
73822784|NCT04878055|147191730|SUPERIORITY|||||||0.153|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At end of treatment (EoT) - Please note that the number of subjects in this analysis is not 270 but 241||||0.153
73822785|NCT04878055|147191731|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Death, reasons for discontinuation for Adverse events and patient transferred to another institution.||||||0.07|||||||Grey's test|||||||0.07
73822786|NCT04878055|147191732|SUPERIORITY|||||||0.07|||||||Gray's test|||number of patients included in the analysis=25||||0.07
73822787|NCT04878055|147191733|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Reasons for discontinuation for Adverse events and patient transferred to another institution.||||||0.668|||||||Gray's test|||Comparison at day 28||||0.668
73822788|NCT04878055|147191734|SUPERIORITY|||||||0.668|||||||Gray's test|||Number of patients included in the analysis = 59||||0.668
73822789|NCT04878055|147191735|SUPERIORITY|||||||0.23|||||||Gray's test|||Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Reasons for discontinuation for Adverse events and patient transferred to another institution.||||0.23
73822790|NCT04878055|147191736|SUPERIORITY|||||||0.444|||||||Wilcoxon (Mann-Whitney)|||day 3 - please note that the number of subjects in this analysis is not 270 but 255||||0.444
73822791|NCT04878055|147191736|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||day 7 - please note that the number of subjects in this analysis is not 270 but 246||||0.357
73822792|NCT04878055|147191736|SUPERIORITY|||||||0.484|||||||Wilcoxon (Mann-Whitney)|||day 14 - please note that the number of subjects in this analysis is not 270 but 209||||0.484
73822793|NCT04878055|147191736|SUPERIORITY|||||||0.753|||||||Wilcoxon (Mann-Whitney)|||day 21 - please note that the number of subjects in this analysis is not 270 but 176||||0.753
73822794|NCT04878055|147191736|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||day 28 - please note that the number of subjects in this analysis is not 270 but 190||||0.26
73822795|NCT04878055|147191736|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||day 60 - please note that the number of subjects in this analysis is not 270 but 201||||0.19
73822796|NCT04878055|147191736|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||day 90 - please note that the number of subjects in this analysis is not 270 but 18||||1.000
73822797|NCT04878055|147191736|SUPERIORITY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||EOS - please note that the number of subjects in this analysis is not 270 but 229||||0.074
73822798|NCT04878055|147191736|SUPERIORITY|||||||0.193|||||||two-sample Mann-Whitney U test|||EOT - please note that the number of subjects in this analysis is not 270 but 241||||0.193
73822799|NCT04878055|147191736|SUPERIORITY|||||||0.131|||||||two-sample Mann-Whitney U test|||Hospital discharge - please note that the number of subjects in this analysis is not 270 but 195||||0.131
73822800|NCT04878055|147191737|SUPERIORITY|||||||0.997|||||||Wilcoxon (Mann-Whitney)|||at day 3 - Please note that the number of subjects in this analysis is not 270 but 155.||||0.997
73822801|NCT04878055|147191737|SUPERIORITY|||||||0.712|||||||Wilcoxon (Mann-Whitney)|||at day 7 - Please note that the number of subjects in this analysis is not 270 but 143.||||0.712
73822802|NCT04878055|147191737|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|||at day 14 - Please note that the number of subjects in this analysis is not 270 but 115.||||0.241
73822803|NCT04878055|147191737|SUPERIORITY|||||||0.528|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 270 but 92.||||0.528
73822804|NCT04878055|147191737|SUPERIORITY|||||||0.814|||||||Wilcoxon (Mann-Whitney)|||at day 28 - Please note that the number of subjects in this analysis is not 270 but 106.||||0.814
73822805|NCT04878055|147191737|SUPERIORITY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||at EOT - Please note that the number of subjects in this analysis is not 270 but 115.||||0.242
73822806|NCT04878055|147191737|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||at hospital discharge (HD) - Please note that the number of subjects in this analysis is not 270 but 65.||||0.722
73822807|NCT04878055|147191738|SUPERIORITY|||||||0.053|||||||two-sample Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 246.||||0.053
73822808|NCT04878055|147191738|SUPERIORITY|||||||0.245|||||||two-sample Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 225.||||0.245
73822809|NCT04878055|147191738|SUPERIORITY|||||||0.067|||||||two-sample Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 118.||||0.067
73822810|NCT04878055|147191738|SUPERIORITY|||||||0.051|||||||two-sample Mann-Whitney U test|||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 54.||||0.051
73822811|NCT04878055|147191738|SUPERIORITY|||||||0.684|||||||two-sample Mann-Whitney U test|||at day 28 - Please note that the number of subjects in this analysis is not 270, but it is 32.||||0.684
73822812|NCT04878055|147191738|SUPERIORITY|||||||1|||||||two-sample Mann-Whitney U test|||at EOS - Please note that the number of subjects in this analysis is not 246, but it is 14.||||1.00
73822813|NCT04878055|147191738|SUPERIORITY|||||||0.48|||||||two-sample Mann-Whitney U test|||at Day 60 - Please note that the number of subjects in this analysis is not 246, but it is 3.||||0.48
73822814|NCT04878055|147191738|SUPERIORITY|||||||0.638|||||||two-sample Mann-W hitney U test|||at Hospital discharge - Please note that the number of subjects in this analysis is 152.||||0.638
73822815|NCT04878055|147191738|SUPERIORITY|||||||0.137|||||||two-sample Mann-W hitney U test|||at EoT - Please note that the number of subjects in this analysis is 212.||||0.137
73822816|NCT04878055|147191739|SUPERIORITY|||||||0.399|||||||Wilcoxon (Mann-Whitney)|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 157||||0.399
73822817|NCT04878055|147191739|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 139||||0.07
73822818|NCT04878055|147191739|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 73||||0.4
73822819|NCT04878055|147191739|SUPERIORITY|||||||0.517|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 23||||0.517
73822820|NCT04878055|147191739|SUPERIORITY|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||at day 28 - Please note that the number of subjects in this analysis is not 270, but it is 17||||0.445
73822821|NCT04878055|147191739|SUPERIORITY|||||||0.324|||||||Wilcoxon (Mann-Whitney)|||at EoT - Please note that the number of subjects in this analysis is not 270, but it is 113||||0.324
73822822|NCT04878055|147191739|SUPERIORITY|||||||0.752|||||||Wilcoxon (Mann-Whitney)|||at Hospital discharge - Please note that the number of subjects in this analysis is not 270, but it is 67.||||0.752
73822823|NCT04878055|147191740|SUPERIORITY|||||||0.447|||||||two-sample Mann-Whitney U test|||Please note that the number of patients in this analysis is not 270 but 255, because patients who used supplement oxygen were 174 in the Reparixin group and 81 in the placebo group.||||0.447
73822824|NCT04878055|147191741|SUPERIORITY|||||||0.065||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|||At day 28 - Please note that the number of patients in this analysis is not 270 but 245, because patients requiring IMV or ECMO were 163 in the Reparixin group and 82 in the placebo group.||||0.065
73822825|NCT04878055|147191741|SUPERIORITY|||||||0.072|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test||||||0.072
73822826|NCT04878055|147191742|SUPERIORITY|||||||0.485||||||Number of subjects included in analysis: 98|two-sample Mann-Whitney U test|||||||0.485
73822827|NCT04878055|147191743|SUPERIORITY|||||||0.267|||||||two-sample Mann-Whitney U test|||Number of subjects included in analysis: 17||||0.267
73822828|NCT04878055|147191744|SUPERIORITY|||||||0.137|||||||two-sample Mann-Whitney U test|||||||0.137
73822829|NCT04878055|147191745|SUPERIORITY|||||||0.002|||||||two-sample Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is 168||||0.002
73822830|NCT04878055|147191745|SUPERIORITY|||||||0.943|||||||two-sample Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 168, but it is 146||||0.943
73822831|NCT04878055|147191745|SUPERIORITY|||||||0.88|||||||two-sample Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 168, but it is 76||||0.88
73822832|NCT04878055|147191745|SUPERIORITY|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 168, but it is 38||||0.458
73822833|NCT04878055|147191745|SUPERIORITY|||||||0.285|||||||two-sample Mann-Whitney U test|||at day 28 - Please note that the number of subjects in this analysis is not 168, but it is 23.||||0.285
73822834|NCT04878055|147191745|SUPERIORITY|||||||0.885|||||||two-sample Mann-Whitney U test|||at EOS - Please note that the number of subjects in this analysis is not 168, but it is 8||||0.885
73822835|NCT04878055|147191745|SUPERIORITY||||||=|0.583|||||||two-sample Mann-Whitney U test|||at HD - Please note that the number of subjects in this analysis is not 270, but it is 74||||= 0.583
73822836|NCT04878055|147191745|SUPERIORITY|||||||0.5|||||||two-sample Mann-Whitney U test|||at End of treatment - Please note that the number of subjects in this analysis is not 270, but it is 131.||||0.5
73822837|NCT04878055|147191746|SUPERIORITY|||||||0.005||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test|Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 245||||0.005
73822838|NCT04878055|147191746|SUPERIORITY|||||||0.283||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 221||||0.283
73822839|NCT04878055|147191746|SUPERIORITY|||||||0.512||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 117||||0.512
73822840|NCT04878055|147191746|SUPERIORITY|||||||0.174|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 51||||0.174
73822841|NCT04878055|147191746|SUPERIORITY|at EOT - Please note that the number of subjects in this analysis is not 270, but it is 206||||||0.133|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||||||0.133
73822842|NCT04878055|147191746|SUPERIORITY|||||||0.009|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||at day 28 ± 2 - Please note that the number of subjects in this analysis is not 270, but it is 29||||0.009
73822843|NCT04878055|147191746|SUPERIORITY|||||||0.593|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to HD - Please note that the number of subjects in this analysis is not 270, but it is 144||||0.593
73822844|NCT04878055|147191746|SUPERIORITY|||||||0.54|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to day 60 - Please note that the number of subjects in this analysis is not 270, but it is 3||||0.540
73822845|NCT04878055|147191746|SUPERIORITY|||||||0.224|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to EOS - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.224
73822846|NCT04878055|147191747|SUPERIORITY|||||||0.68|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to day 3 - Please note that the number of subjects in this analysis is not 270, but it is 15||||0.68
73822847|NCT04878055|147191747|SUPERIORITY|||||||0.272||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 7 - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.272
73822848|NCT04878055|147191747|SUPERIORITY|||||||1||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 14 - Please note that the number of subjects in this analysis is not 270, but it is 13||||1.000
73822849|NCT04878055|147191747|SUPERIORITY|||||||0.903||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 21 - Please note that the number of subjects in this analysis is not 270, but it is 9||||0.903
73822850|NCT04878055|147191747|SUPERIORITY|||||||0.432||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to EOT - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.432
73822851|NCT04878055|147191747|SUPERIORITY|||||||0.105||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 28 - Please note that the number of subjects in this analysis is not 270, but it is 6||||0.105
73822852|NCT04878055|147191747|SUPERIORITY|||||||0.551||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to HD - Please note that the number of subjects in this analysis is not 270, but it is 8||||0.551
73822853|NCT04878055|147191748|SUPERIORITY||Odds Ratio (OR)|0.52||||0.232|TWO_SIDED|95.0|0.178|1.522||Analysis is based on logistic regression model with proportion of patients died up to Day 60 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables.|Regression, Logistic|||up to day 60||1.522|0.178|0.232
73822854|NCT04878055|147191748|SUPERIORITY|Analysis is based on logistic regression model with proportion of patients died up to Day 90 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables.|Odds Ratio (OR)|0.246||||0.158|TWO_SIDED|95.0|0.034|1.782|||Regression, Logistic|||Up to Day 90||1.782|0.034|0.158
73822855|NCT04878055|147191749|SUPERIORITY|Freedom from (time to) death or respiratory failure (need of invasive mechanical ventilation or ECMO or admission to ICU linked to worsening of respiratory parameters compared to baseline) up to Day 90 was performed using the same Kaplan-Meier analysis and the one-sided log-rank test that were used to test for differences between groups||||||0.33607|||||||Log Rank|||||||0.33607
73822856|NCT02372344|147191753|SUPERIORITY_OR_OTHER||Geometric least square (LS) mean ratio|0.64|||||TWO_SIDED|95.0|0.54|0.77||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.77|0.54|
73822857|NCT02372344|147191753|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.71|||||TWO_SIDED|95.0|0.59|0.86||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.86|0.59|
73822858|NCT02372344|147191754|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.35|||||TWO_SIDED|95.0|0.27|0.47||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.47|0.27|
73822859|NCT02372344|147191754|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.44|||||TWO_SIDED|95.0|0.33|0.59||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.59|0.33|
73822860|NCT02372344|147191754|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.46|||||TWO_SIDED|95.0|0.36|0.57||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.57|0.36|
73822861|NCT02372344|147191754|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.57|||||TWO_SIDED|95.0|0.45|0.71||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.71|0.45|
73822862|NCT02372344|147191755|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.56|||||TWO_SIDED|95.0|0.45|0.69||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.69|0.45|
73822863|NCT02372344|147191755|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.55||||||95.0|0.44|0.69||||||Total EPA: Ratio of Before Meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.69|0.44|
73822864|NCT02372344|147191755|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||1.04|0.73|
73822865|NCT02372344|147191755|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||1.02|0.72|
73822866|NCT02258217|147191756|EQUIVALENCE|"We created a difference in ADL score variable. This was calculated as follows:~ADL score (new relapse) - ADL score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|3.03||0.003|TWO_SIDED|95.0|-2.9|-0.66|||Paired t-test, 2 sided|||"We compared the two ADL scores measured in the same arm at different timepoints (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0~We used the Paired t-test to compare the pre - post ADL scores."||-0.66|-2.9|0.003
73822867|NCT02258217|147191757|EQUIVALENCE|"We created a difference in ADL score variable. This was calculated as follows:~ADL score (new relapse) - ADL score (after treatment of current relapse) This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|3.09||0.99|TWO_SIDED|95.0|-1.22|1.22|||Paired t-test, 2 sided|||"We compared the two RSH scores measured in the same arm at different time points (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0 We used the Paired t-test to compare the pre - post RSH scores."||1.22|-1.22|0.99
73822868|NCT02258217|147191759|EQUIVALENCE|"We created a difference in PCS score variable. This was calculated as follows:~PCS score (new relapse) - PCS score (after treatment of current relapse). This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|4.42||0.03|TWO_SIDED|95.0|-3.67|-0.18|||Paired t-test, two sided|||"We compared the two PCS scores measured in the same arm at different timepoints (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0 We used the Paired t-test to compare the pre - post PCS scores."||-0.18|-3.67|0.03
73822869|NCT02258217|147191760|EQUIVALENCE|"We created a difference in MSIS physical score variable. This was calculated as follows:~MSIS physical score (new relapse) - MSIS physical score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|2.5||||0.19|TWO_SIDED||||||Wilcoxon Signed Rank test|||"We compared the two MSIS physical scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post MSIS physical scores."||||0.19
73822870|NCT02258217|147191761|EQUIVALENCE|"We created a difference in MSIS psychological score variable. This was calculated as follows:~MSIS psychological score (new relapse) - MSIS psychological score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|6.3||0.01|TWO_SIDED|95.0|0.74|5.45|||Paired t-test, 2 sided|||"We compared the two MSIS psychological scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0~We used the Paired t-test to compare the pre - post MSIS psychological scores."||5.45|0.74|0.01
73822871|NCT02258217|147191762|EQUIVALENCE|"We created a difference in EDSS score variable. This was calculated as follows:~EDSS score (new relapse) - EDSS score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|0.0||||0.23|TWO_SIDED||||||Wilcoxon Signed Rank test||The interquartile range for the median difference in EDSS scores is 0.0 to 0.5|"We compared the two EDSS scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post EDSS scores."||||0.23
73822872|NCT02258217|147191763|EQUIVALENCE|"We created a difference in SAGE score variable. This was calculated as follows:~SAGE score (new relapse) - SAGE score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|0.0||||0.44|TWO_SIDED||||||Wilcoxon Signed Rank test||The interquartile range for the difference in medians is -1 to 0.|"We compared the two SAGE scores measured in the same arm at different time points (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post SAGE scores."||||0.44
73822873|NCT00327717|147191817|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||ANOVA|||||||0.028
73822874|NCT00327717|147191818|SUPERIORITY_OR_OTHER|||||||0.253||95.0|||||ANOVA|||||||0.253
73822875|NCT00327717|147191819|SUPERIORITY_OR_OTHER|||||||0.211||95.0|||||ANOVA|||||||0.211
73822876|NCT00327717|147191820|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||ANOVA|||||||0.516
73822877|NCT00327717|147191821|SUPERIORITY_OR_OTHER|||||||0.044|||||||X^2 test|||||||0.044
73822878|NCT00327717|147191822|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||X^2 test|||||||0.090
73822879|NCT00327717|147191823|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||X^2 test|||||||0.090
73822880|NCT00327717|147191824|SUPERIORITY_OR_OTHER|||||||0.162||95.0|||||X^2 test|||||||0.162
73822881|NCT00327717|147191825|SUPERIORITY_OR_OTHER|||||||0.678||95.0|||||X^2 test|||||||0.678
73822882|NCT02080364|147191827|SUPERIORITY|||||||0.3386||||||p-value for comparison to Placebo|Mixed Models Analysis|||||||0.3386
73822883|NCT02080364|147191827|SUPERIORITY|||||||0.1992||||||p-value for compairons to Placebo|Mixed Models Analysis|||||||0.1992
73822884|NCT02080364|147191828|SUPERIORITY|||||||0.9394||||||p-value for comparison to Placebo.|Mixed Models Analysis|||||||0.9394
73822885|NCT02080364|147191828|SUPERIORITY||||||||||||||||||MMRM model does not converge. LS Mean and p-value are NA.|||
73822886|NCT03705286|147191878|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|1.87||0.78|TWO_SIDED|95.0|-4.21|3.17|||Regression, Linear|||We evaluated whether there are differences in the Physical Component Score (PCS) for QOL between the PU-EVAC and PVC treatment groups by comparing their respective mean scores (i.e., mean\[PU-EVAC\] - mean\[PVC\] ). We modeled the data using linear regression and used robust standard error estimates to construct our statistical test and 95% confidence interval estimates. We also estimated the treatment groups' mean quality of life scores with standard error estimates and 95% confidence intervals.||3.17|-4.21|0.78
73822887|NCT03705286|147191878|SUPERIORITY||Mean Difference (Final Values)|-2.98|STANDARD_ERROR_OF_MEAN|2.05||0.15|TWO_SIDED|95.0|-7.03|1.07|||Regression, Linear|||We evaluated whether there are differences in the Mental Component Score (MCS) for QOL between the PU-EVAC and PVC treatment groups by comparing their respective mean scores (i.e., mean\[PU-EVAC\] - mean\[PVC\] ). We modeled the data using linear regression and used robust standard error estimates to construct our statistical test and 95% confidence interval estimates. We also estimated the treatment groups' mean quality of life scores with standard error estimates and 95% confidence intervals.||1.07|-7.03|0.15
73822888|NCT03705286|147191879|SUPERIORITY||Risk Difference (RD)|0.05||||0.05|TWO_SIDED|98.0|-0.07|0.17|||Regression, Logistic|||||0.17|-0.07|0.05
73822889|NCT03705286|147191880|SUPERIORITY||Risk Difference (RD)|0.126||||0.05|TWO_SIDED|95.0|-0.01|0.26|||Regression, Logistic|||We evaluated whether there are differences in the risk of laryngeal injury between the PU-EVAC and PVC treatment groups, comparing their respective risk difference (i.e., probability\[PU-EVAC\] - probability \[PVC\]). We fit a logistic regression model and incorporated robust (i.e., Huber-White heteroskedastic consistent) standard error estimates for our hypothesis test and 95% confidence interval estimates.||0.26|-0.01|0.05
73822890|NCT00765817|147191886|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73822891|NCT00765817|147191887|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73822892|NCT00765817|147191888|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
73822893|NCT00765817|147191889|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||ANCOVA|||||||0.174
73822894|NCT00765817|147191891|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||ANCOVA|||||||0.203
73822895|NCT00765817|147191892|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|||||||0.063
73822896|NCT00765817|147191893|SUPERIORITY_OR_OTHER|||||||0.745||95.0|||||ANCOVA|||||||0.745
73822897|NCT00765817|147191894|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||ANCOVA|||||||0.933
73822898|NCT00765817|147191895|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73822899|NCT00765817|147191896|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||ANCOVA|||||||0.226
73822900|NCT00765817|147191897|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||ANCOVA|||||||0.026
73822901|NCT00765817|147191898|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANCOVA|||||||0.070
73822902|NCT00765817|147191899|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||ANCOVA|||||||0.011
73822903|NCT00765817|147191900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
73822904|NCT00765817|147191901|SUPERIORITY_OR_OTHER|||||||0.666||95.0|||||Negative binomial regression model|||||||0.666
73822905|NCT00765817|147191902|SUPERIORITY_OR_OTHER|||||||0.486||95.0|||||Fisher Exact|||||||0.486
73822906|NCT04776928|147191903|SUPERIORITY|||||||0.01|||||||Two-part regression model|||||||0.010
73822907|NCT00103285|147191906|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.17|||||TWO_SIDED|95.0|1.61|16.63|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points.|Physical Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||16.63|1.61|
73822908|NCT00103285|147191906|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.99|||||TWO_SIDED|95.0|1.21|3.27|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points|Social Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||3.27|1.21|
73822909|NCT00103285|147191906|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.03|3.34|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points|Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||3.34|1.03|
73822910|NCT00103285|147191907|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.542|||||TWO_SIDED|95.0|1.974|3.273|||Regression, Cox|||4981 eligible evaluable patients enrolled on AALL0331 had MRD evaluation at Day 29 of induction. MRD status defined as negative (\<0.1%) or positive (\>=0.1%). MRD status ( positive vs. negative) was correlated with EFS using Cox regression analysis.||3.273|1.974|
73822911|NCT00103285|147191909|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.131|||||TWO_SIDED|95.0|0.101|0.17|||Chi-squared|||MRD status ( positive vs. negative) was correlated with Early Marrow Status (M1 vs M2/M3) using Chi Square test.||0.17|0.101|
73822912|NCT00103285|147191910|OTHER||Odds Ratio (OR)|4.1|||||TWO_SIDED|95.0|1.31|12.73|||Regression, Logistic|||Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these 159 had data at 1 month after diagnosis and 96 at 3 months post therapy.||12.73|1.31|
73822913|NCT00913081|147191913|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow. Because quercetin has not been used to inhibit flushing from niacin in humans, sample size could not be determined statistically. A sample size of 8 men and 8 women was expected to allow separate estimates of effect size, variability, and shape of distribution for men and women.||||0.5
73822914|NCT00913081|147191913|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.||||0.8
73822915|NCT00913081|147191913|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.||||0.5
73822916|NCT00377637|147191948|SUPERIORITY_OR_OTHER|||||||0.478||95.0|||||Regression, Logistic|Covariates included Treatment, Race, Geographical Region, and WHO Lupus Nephritis Class V and specified interaction terms.||||||0.478
73822917|NCT00377637|147191949|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Testing at the alpha=0.05 level was applied with no adjustments made for multiplicity.|Log Rank|||The difference in Kaplan-Meier survival curves between treatment groups (MMF-AZA) was assessed using a log-rank test, which is a non-parametric test to compare the survival distributions of two groups commonly used to analyze time-to-event endpoints.||||0.003
73822918|NCT03416270|147191979|OTHER|||||||0.36||||||12 weeks|Wilcoxon (Mann-Whitney)|||||||0.36
73822919|NCT03416270|147191979|OTHER|||||||0.56||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.56
73822920|NCT03416270|147191980|OTHER|||||||0.303|||||||Wilcoxon (Mann-Whitney)|||||||0.303
73822921|NCT03416270|147191981|OTHER|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
73822922|NCT03416270|147191982|OTHER|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||||||0.599
73822923|NCT03416270|147191983|OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
73822924|NCT03416270|147191984|OTHER|||||||0.405|||||||Wilcoxon (Mann-Whitney)|||||||0.405
73822925|NCT03416270|147191985|OTHER|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||||||0.536
73822926|NCT03416270|147191986|OTHER|||||||0.443|||||||Wilcoxon (Mann-Whitney)|||||||0.443
73822927|NCT03416270|147191987|OTHER|||||||0.849|||||||Wilcoxon (Mann-Whitney)|||||||0.849
73822928|NCT03416270|147191988|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
73822929|NCT03416270|147191989|OTHER|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||||||0.844
73822930|NCT03416270|147191990|OTHER|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||||||0.262
73822931|NCT03416270|147191991|OTHER|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||||||0.802
73822932|NCT03416270|147191992|OTHER|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
73822933|NCT03416270|147191993|OTHER|||||||0.618|||||||Wilcoxon (Mann-Whitney)|||||||0.618
73822934|NCT03416270|147191994|OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
73822935|NCT03416270|147191995|OTHER|||||||0.53||||||12 week|Wilcoxon (Mann-Whitney)|||||||0.53
73822936|NCT03416270|147191995|OTHER|||||||0.89||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.89
73822937|NCT03416270|147191996|OTHER|||||||0.26||||||12 weeks|Wilcoxon (Mann-Whitney)|||||||0.26
73822938|NCT03416270|147191996|OTHER|||||||0.56||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.56
73822939|NCT00447772|147192002|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.322|||=|0.2552|TWO_SIDED|95.0|-0.877|0.233|||ANCOVA||The comparative analysis is based on adjusted means data.|An analysis of covariance (ANCOVA) model included the baseline total Tsui score (patient in sitting position) as covariate and the main type of CD as between-group factor (due to non-significance the interaction between baseline total Tsui score and the main type of CD was removed from the model).||0.233|-0.877|=0.2552
73822940|NCT00875563|147192022|NON_INFERIORITY_OR_EQUIVALENCE|An exact test method (Sidik K. 2003, Statistics in Medicine 22: 265-278) for matched controls was used, at a type I error rate of 0.05 and a non-inferiority margin of 10%. 38 pairs of patients were determined necessary, and the power was calculated to be 0.92.||||||0.02|TWO_SIDED||||||Exact test for matched pairs|||Patients treated with the Zenith® Fenestrated AAA Endovascular Graft were compared with matched patients treated with the Zenith® AAA Endovascular Graft.||||0.02
73822941|NCT03257436|147192038|OTHER|"A power calculation using a sample size of 61 subjects as the non-responders with the LV MSP on was calculated based on a one-sided exact test for a single binomial proportion, using SAS Version 9.4 with the following assumptions:~* Performance goal = 90%~* Expected LV MSP feature-related CFR rate between 6 and 12 Month Visit = 98%~* Significance level = 5%~* Power = 80%"|Kaplan Meir Methodology|99.0|||||ONE_SIDED|95.0|94.1|||||||"The LV MSP feature-related CFR between the 6 Month Visit and the 12 Month Visit was calculated using Kaplan-Meier methodology.~H0: LV MSP feature-related complication-free rate between 6 Month Visit and 12 Month Visit ≤ 90%.~The sample size of 61 subjects was required to evaluate the Primary Safety Endpoint using an exact test since a power calculation cannot be directly calculated for a one group Kaplan-Meier analysis."|||94.1|
73822942|NCT03257436|147192039|OTHER|Even though fewer subjects (78) were available for the effectiveness endpoint analysis than originally planned (110), the study was still powered at approximately 90%|Proportion|51.3|||||ONE_SIDED|95.0|41.1|||||||"The effectiveness endpoint for SMART MSP PAS is the proportion of the LV MSP Group with an Improved CCS. For this endpoint, those subjects in the LV MSP Group that become responders will be defined as having an Improved CCS.~H0: Proportion of LV MSP Group subjects with Improved CCS from 6 Month Visit through 12 Month Visit ≤ 5%"|||41.1|
73822943|NCT01305811|147192060|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||general estimating equations|||||||0.03
73822944|NCT01305811|147192061|SUPERIORITY_OR_OTHER||||||=|0.22|TWO_SIDED||||||t-test, 2 sided|||In our original proposal to the funder, to protect our main outcome from possibly large attrition, we proposed to initially test mean differences between groups following 2 months of treatment or wait list using Student's t-tests at an alpha=0.05.||||=0.22
73822945|NCT02849743|147192066|OTHER||Least Means Square|-0.5||||0.92|TWO_SIDED||||||Regression, Linear|||||||0.92
73822946|NCT02849743|147192067|OTHER||Regression Coefficient|-15784.0||||0.57|TWO_SIDED||||||Regression, Linear|||||||0.57
73822947|NCT02849743|147192068|OTHER||Regression Coefficient|48.0||||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
73822948|NCT02849743|147192069|OTHER||Regression Coefficient|-2.8||||0.55|TWO_SIDED||||||Regression, Linear|||||||0.55
73822949|NCT02849743|147192070|OTHER||Regression Coefficient|1.2||||0.86|TWO_SIDED||||||Regression, Linear|||||||0.86
73822950|NCT02849743|147192071|OTHER||Regression Coefficient|2.4||||0.88|TWO_SIDED||||||Regression, Linear|||||||0.88
73822951|NCT02849743|147192072|OTHER||Regression Coefficient|-0.02||||0.5|TWO_SIDED||||||Regression, Linear|||||||0.50
73822952|NCT02849743|147192073|OTHER||Regression Coefficient|-0.02||||0.49|TWO_SIDED||||||Regression, Linear|||||||0.49
73822953|NCT02849743|147192075|OTHER||Regression Coefficient|-0.7||||0.68|TWO_SIDED||||||Regression, Linear|||||||0.68
73822954|NCT02849743|147192076|OTHER||Regression Coefficient|-0.6||||0.52|TWO_SIDED||||||Regression, Linear|||||||0.52
73822955|NCT02849743|147192077|OTHER||Regression Coefficient|-0.2||||0.91|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Anxiety||||0.91
73822956|NCT02849743|147192077|OTHER||Regression Coefficient|-0.2||||0.91|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Depression||||0.91
73822957|NCT02849743|147192077|OTHER||Regression Coefficient|4.7||||0.04|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Cognition||||0.04
73822958|NCT02849743|147192077|OTHER||Regression Coefficient|2.3||||0.36|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Social Function||||0.36
73822959|NCT02849743|147192078|OTHER||Regression Coefficient|0.05||||0.64|TWO_SIDED||||||Regression, Linear|||||||0.64
73822960|NCT02849743|147192079|OTHER||Regression Coefficient|0.05||||0.83|TWO_SIDED||||||Regression, Linear|||||||0.83
73822961|NCT03064113|147192082|SUPERIORITY||Difference of LS Mean|173.8|||<|0.001|TWO_SIDED|95.0|112.4|235.3|||t-test, 2 sided|||||235.3|112.4|<0.001
73822962|NCT03064113|147192082|SUPERIORITY||Difference of LS Mean|169.3|||<|0.001|TWO_SIDED|95.0|107.8|230.8|||t-test, 2 sided|||||230.8|107.8|<0.001
73822963|NCT03064113|147192082|SUPERIORITY||Difference of LS Mean|175.6|||<|0.001|TWO_SIDED|95.0|114.1|237.2|||t-test, 2 sided|||||237.2|114.1|<0.001
73822964|NCT03064113|147192083|SUPERIORITY||Slope|112.5||||0.001|TWO_SIDED|95.0|44.5|180.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||180.5|44.5|0.001
73822965|NCT03064113|147192083|SUPERIORITY||Difference of LS Mean|123.4|||<|0.001|TWO_SIDED|95.0|54.6|192.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||192.3|54.6|<0.001
73822966|NCT03064113|147192083|SUPERIORITY||Difference of LS Mean|15.3||||0.659|TWO_SIDED|95.0|-53.5|94.1|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||94.1|-53.5|0.659
73822967|NCT03064113|147192083|SUPERIORITY||Difference of LS Mean|102.8|||<|0.001|TWO_SIDED|95.0|54.1|151.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr||151.5|54.1|<0.001
73822968|NCT03064113|147192083|SUPERIORITY||Difference of LS Mean|136.6|||<|0.001|TWO_SIDED|95.0|87.8|185.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr||185.3|87.8|<0.001
73822969|NCT03064113|147192083|SUPERIORITY|Tx Difference of LS Mean FEV1 at 24 hr|Difference of LS Mean|-24.2||||0.327|TWO_SIDED|95.0|-72.9|24.6|||t-test, 2 sided|||||24.6|-72.9|0.327
73822970|NCT03064113|147192084|SUPERIORITY||Difference of LS Mean|26.4|||<|0.001|TWO_SIDED|95.0|18.0|34.8|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||34.8|18.0|<0.001
73822971|NCT03064113|147192084|SUPERIORITY||Difference of LS Mean|29.1|||<|0.001|TWO_SIDED|95.0|20.8|37.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||37.4|20.8|<0.001
73822972|NCT03064113|147192084|SUPERIORITY||Difference of LS Mean|25.6|||<|0.001|TWO_SIDED|95.0|17.3|33.9|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||33.9|17.3|<0.001
73822973|NCT03064113|147192084|SUPERIORITY||Difference of LS Mean|20.1|||<|0.001|TWO_SIDED|95.0|12.1|28.2|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs||28.2|12.1|<0.001
73822974|NCT03064113|147192084|SUPERIORITY||Difference of LS Mean|25.4|||<|0.001|TWO_SIDED|95.0|17.4|33.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs||33.4|17.4|<0.001
73822975|NCT03064113|147192084|SUPERIORITY||Difference of LS Mean|10.6||||0.01|TWO_SIDED|95.0|2.5|18.6|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hr||18.6|2.5|0.010
73822976|NCT03064113|147192085|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.003
73822977|NCT03064113|147192085|SUPERIORITY||Difference of LS Mean|0.1||||0.046|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.046
73822978|NCT03064113|147192085|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.003
73822979|NCT03064113|147192085|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.003
73822980|NCT03064113|147192085|SUPERIORITY||Difference of LS Mean|0.1||||0.048|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.048
73822981|NCT03064113|147192085|SUPERIORITY||Difference of LS Mean|0.1||||0.007|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.007
73822982|NCT03064113|147192086|SUPERIORITY||Difference of LS Mean|0.1||||0.054|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.1|-0.0|0.054
73822983|NCT03064113|147192086|SUPERIORITY||Difference of LS Mean|0.1||||0.045|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.045
73822984|NCT03064113|147192086|SUPERIORITY||Difference of LS Mean|0.0||||0.503|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.1|-0.0|0.503
73822985|NCT03064113|147192086|SUPERIORITY||Difference of LS Mean|0.0||||0.183|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.1|-0.0|0.183
73822986|NCT03064113|147192086|SUPERIORITY||Difference of LS Mean|0.0||||0.422|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.1|-0.0|0.422
73822987|NCT03064113|147192086|SUPERIORITY||Difference of LS Mean|0.0||||0.287|TWO_SIDED|95.0|-0.1|0.0|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.0|-0.1|0.287
73822988|NCT03064113|147192088|SUPERIORITY||Difference of LS Mean|3975.5|||<|0.001|TWO_SIDED|95.0|2007.3|5943.7|||t-test, 2 sided|||||5943.7|2007.3|<0.001
73822989|NCT03064113|147192088|SUPERIORITY||Difference of LS Mean|5888.9|||<|0.001|TWO_SIDED|95.0|3924.4|7853.4|||t-test, 2 sided|||||7853.4|3924.4|<0.001
73822990|NCT03064113|147192088|SUPERIORITY||Difference of LS Mean|2654.7||||0.009|TWO_SIDED|95.0|689.7|4619.6|||t-test, 2 sided|||||4619.6|689.7|0.009
73822991|NCT01096160|147192099|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-7.08||||0.1194|TWO_SIDED|90.0|-17.1|2.92|||Linear mixed effects model|||||2.92|-17.1|0.1194
73822992|NCT01096160|147192099|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-13.1||||0.0224|TWO_SIDED|90.0|-23.7|-2.48|||Linear mixed effects model|||||-2.48|-23.7|0.0224
73822993|NCT01096160|147192099|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|0.33||||0.4791|TWO_SIDED|90.0|-10.3|10.91|||Linear mixed effects model|||||10.91|-10.3|0.4791
73822994|NCT01096160|147192099|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-8.21||||0.0705|TWO_SIDED|90.0|-17.4|1.01|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||1.01|-17.4|0.0705
73822995|NCT01096160|147192100|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|3.85||||0.1161|TWO_SIDED|90.0|-1.51|9.22|||Linear mixed effects model|||||9.22|-1.51|0.1161
73822996|NCT01096160|147192100|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|7.28||||0.0189|TWO_SIDED|90.0|1.6|12.97|||Linear mixed effects model|||||12.97|1.60|0.0189
73822997|NCT01096160|147192100|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|0.26||||0.4689|TWO_SIDED|90.0|-5.42|5.95|||Linear mixed effects model|||||5.95|-5.42|0.4689
73822998|NCT01096160|147192100|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|4.06||||0.0869|TWO_SIDED|90.0|-0.89|9.01|||Linear mixed effects model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||9.01|-0.89|0.0869
73822999|NCT01096160|147192101|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-9.87||||0.003|TWO_SIDED|90.0|-15.7|-4.09|||Linear mixed effects model|||||-4.09|-15.7|0.003
73823000|NCT01096160|147192101|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-11.2||||0.002|TWO_SIDED|90.0|-17.3|-5.1|||Linear mixed effects model|||||-5.10|-17.3|0.002
73823001|NCT01096160|147192101|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-5.18||||0.08|TWO_SIDED|90.0|-11.3|0.95|||Linear mixed effcts model|||||0.95|-11.3|0.080
73823002|NCT01096160|147192101|OTHER|Difference in change from baseline in AIx (TWA\^0-24hrs)|Mean Difference (Final Values)|-6.79||||0.019|TWO_SIDED|90.0|-12.1|-1.46|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||-1.46|-12.1|0.019
73823003|NCT01096160|147192102|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.28||||0.318|TWO_SIDED|90.0|0.53|3.05|||Linear mixed effects model|||||3.05|0.53|0.318
73823004|NCT01096160|147192102|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.66||||0.17|TWO_SIDED|90.0|0.66|4.17|||Linear mixed effects model|||||4.17|0.66|0.17
73823005|NCT01096160|147192102|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.41||||0.054|TWO_SIDED|90.0|0.16|1.02|||Linear mixed effcts model|||||1.02|0.16|0.054
73823006|NCT01096160|147192102|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.78||||0.297|TWO_SIDED|90.0|0.35|1.73|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||1.73|0.35|0.297
73823007|NCT04607135|147192121|OTHER|||||||0.0003||||||F-statistic = 11.71|Welch's ANOVA|||||||0.0003
73823008|NCT04607135|147192121|OTHER|||||||0.002||||||q-statistic = 6.74|Games-Howell post-hoc test|||||||0.002
73823009|NCT04607135|147192121|OTHER|||||||0.24||||||q-statistic = 2.34|Games-Howell post-hoc test|||||||0.24
73823010|NCT04607135|147192121|OTHER|||||||0.35||||||q-statistic = 2.04|Games-Howell post-hoc test|||||||0.35
73823011|NCT04607135|147192122|OTHER|||||||0.99|||||||Kruskal-Wallis|||||||0.99
73823012|NCT04607135|147192123|OTHER|||||||0.74|||||||Kruskal-Wallis|||||||0.74
73823013|NCT03990051|147192136|SUPERIORITY|Comparison of changes in score from baseline, Active - Placebo.||||||0.0197|||||||Mixed Models Analysis|||||||0.0197
73823014|NCT03990051|147192137|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0039|||||||Mixed Models Analysis|||||||0.0039
73823015|NCT03990051|147192138|SUPERIORITY|Comparison of changes in score from baseline.|||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73823016|NCT03990051|147192139|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0002|||||||ANCOVA|||||||0.0002
73823017|NCT03990051|147192140|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0138|||||||Mixed Models Analysis|||||||0.0138
73823018|NCT03990051|147192141|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
73823019|NCT03990051|147192142|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0849|||||||Mixed Models Analysis|||||||0.0849
73823020|NCT03990051|147192143|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0041|||||||Mixed Models Analysis|||||||0.0041
73823021|NCT03990051|147192144|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0006|||||||Mixed Models Analysis|||||||0.0006
73823022|NCT03990051|147192145|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0143|||||||Mixed Models Analysis|||||||0.0143
73823023|NCT03990051|147192146|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0398|||||||Mixed Models Analysis|||||||0.0398
73823024|NCT03990051|147192147|SUPERIORITY|Comparison of changes in score from baseline.||||||-3.97|||||||Mixed Models Analysis|||||||-3.97
73823025|NCT03990051|147192148|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
73823026|NCT03990051|147192149|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
73823027|NCT03990051|147192150|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0067|||||||Mixed Models Analysis|||||||0.0067
73823028|NCT03990051|147192151|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0636|||||||Mixed Models Analysis|||||||0.0636
73823029|NCT03990051|147192152|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0028|||||||Mixed Models Analysis|||||||0.0028
73823030|NCT03990051|147192153|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0067|||||||Mixed Models Analysis|||||||0.0067
73823031|NCT03990051|147192154|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0105|||||||Mixed Models Analysis|||||||0.0105
73823032|NCT03990051|147192155|SUPERIORITY|Comparison of changes in score from baseline.||||||0.001|||||||Mixed Models Analysis|||||||0.0010
73823033|NCT03990051|147192156|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0155|||||||Mixed Models Analysis|||||||0.0155
73823034|NCT03990051|147192157|SUPERIORITY|Comparison of changes in score from baseline.||||||0.016|||||||Mixed Models Analysis|||||||0.0160
73823035|NCT03990051|147192158|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0117|||||||Mixed Models Analysis|||||||0.0117
73823036|NCT03990051|147192159|SUPERIORITY|Comparison of changes in score from baseline.||||||0.4649|||||||Mixed Models Analysis|||||||0.4649
73823037|NCT03990051|147192160|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0082|||||||Mixed Models Analysis|||||||0.0082
73823038|NCT03990051|147192161|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0225|||||||Mixed Models Analysis|||||||0.0225
73823039|NCT03990051|147192162|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1822|||||||Mixed Models Analysis|||||||0.1822
73823040|NCT03990051|147192163|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0515|||||||Mixed Models Analysis|||||||0.0515
73823041|NCT03990051|147192164|SUPERIORITY|Comparison of changes in score from baseline.||||||0.044|||||||Mixed Models Analysis|||||||0.044
73823042|NCT03990051|147192165|SUPERIORITY|Comparison of changes of score from baseline.||||||0.083|||||||Mixed Models Analysis|||||||0.083
73823043|NCT03990051|147192166|SUPERIORITY|Comparison of changes in score from baseline.||||||0.7147|||||||Mixed Models Analysis|||||||0.7147
73823044|NCT03990051|147192167|SUPERIORITY|Comparison of changes in score from baseline.||||||0.8251|||||||Mixed Models Analysis|||||||0.8251
73823045|NCT03990051|147192168|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0435|||||||Mixed Models Analysis|||||||0.0435
73823046|NCT03990051|147192169|SUPERIORITY|Comparison of changes in score from baseline.||||||0.013|||||||Mixed Models Analysis|||||||0.0130
73823047|NCT03990051|147192170|SUPERIORITY|Comparison of changes in score from baseline.||||||0.3205|||||||Mixed Models Analysis|||||||0.3205
73823048|NCT03990051|147192171|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1401|||||||Mixed Models Analysis|||||||0.1401
73823049|NCT03990051|147192172|SUPERIORITY|Comparison in changes in score from baseline.||||||0.0098|||||||ANCOVA|||||||0.0098
73823050|NCT03990051|147192173|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1032|||||||Mixed Models Analysis|||||||0.1032
73823051|NCT03990051|147192174|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0389|||||||Mixed Models Analysis|||||||0.0389
73823052|NCT03990051|147192175|OTHER||||||<|1e-05|||||||t-test, 2 sided|||Score in 1 year compared to baseline||||<0.00001
73823053|NCT03990051|147192176|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823054|NCT03990051|147192177|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823055|NCT03990051|147192178|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823056|NCT03990051|147192179|OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
73823057|NCT03990051|147192180|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
73823058|NCT03990051|147192181|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823059|NCT03990051|147192182|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823060|NCT03990051|147192183|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823061|NCT03990051|147192184|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823062|NCT03990051|147192185|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823063|NCT03990051|147192186|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823064|NCT03990051|147192187|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
73823065|NCT03990051|147192188|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823066|NCT03990051|147192189|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823067|NCT03990051|147192190|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823068|NCT03990051|147192191|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823069|NCT03990051|147192192|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
73823070|NCT03193047|147192198|SUPERIORITY||Least squares mean difference|-30.261|STANDARD_ERROR_OF_MEAN|5.502|<|0.001|TWO_SIDED|95.0|-41.324|-19.199|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|||-19.199|-41.324|<0.001
73823071|NCT03193047|147192199|SUPERIORITY||Lease squares mean difference|-35.884|STANDARD_ERROR_OF_MEAN|5.159|<|0.001|TWO_SIDED|95.0|-46.303|-25.466|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|||-25.466|-46.303|<0.001
73823072|NCT03193047|147192200|SUPERIORITY||Least squares mean difference|-38.25|STANDARD_ERROR_OF_MEAN|5.602|<|0.001|TWO_SIDED|95.0|-49.558|-26.944|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 1||-26.944|-49.558|<0.001
73823073|NCT03193047|147192200|SUPERIORITY||Least squares mean difference|-29.9|STANDARD_ERROR_OF_MEAN|5.606|<|0.001|TWO_SIDED|95.0|-41.176|-18.626|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 2||-18.626|-41.176|<0.001
73823074|NCT03193047|147192201|SUPERIORITY||Least squares mean difference|-27.031|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|95.0|-37.509|-16.553|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 1||-16.553|-37.509|<0.001
73823075|NCT03193047|147192201|SUPERIORITY||Least squares mean difference|-24.469|STANDARD_ERROR_OF_MEAN|4.33|<|0.001|TWO_SIDED|95.0|-33.225|-15.713|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 2||-15.713|-33.225|<0.001
73823076|NCT03193047|147192201|SUPERIORITY||Least squares mean difference|-31.64|STANDARD_ERROR_OF_MEAN|4.689|<|0.001|TWO_SIDED|95.0|-41.116|-22.163|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 1||-22.163|-41.116|<0.001
73823077|NCT03193047|147192201|SUPERIORITY||Least squares mean difference|-24.246|STANDARD_ERROR_OF_MEAN|4.838|<|0.001|TWO_SIDED|95.0|-33.987|-14.505|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 2||-14.505|-33.987|<0.001
73823078|NCT03193047|147192201|SUPERIORITY||Least squares mean difference|-21.941|STANDARD_ERROR_OF_MEAN|3.572|<|0.001|TWO_SIDED|95.0|-29.153|-14.729|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 1||-14.729|-29.153|<0.001
73823079|NCT03193047|147192201|SUPERIORITY||Least squares mean difference|-17.52|STANDARD_ERROR_OF_MEAN|3.809|<|0.001|TWO_SIDED|95.0|-25.201|-9.839|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 2||-9.839|-25.201|<0.001
73823080|NCT03193047|147192202|SUPERIORITY||Median treatment difference|-32.479|STANDARD_ERROR_OF_MEAN|17.395||0.046|TWO_SIDED|95.0|-70.524|-2.339|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 1||-2.339|-70.524|0.046
73823081|NCT03193047|147192202|SUPERIORITY||Median treatment difference|-28.512|STANDARD_ERROR_OF_MEAN|12.124||0.029|TWO_SIDED|95.0|-51.455|-3.93|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 2||-3.930|-51.455|0.029
73823082|NCT00186485|147192237|SUPERIORITY_OR_OTHER||||||<|0.001||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the HAM-D rating scale: total scores (F (4,96) = 19.88, p \< .001) over the 4 week treatment period.|ANOVA|Repeated Measures Anova||ANOVA with partial eta accounts for multiple repeated measures over the course of treatment.||||<0.001
73823083|NCT00186485|147192238|SUPERIORITY_OR_OTHER||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the BDI total scores (F (4,96) = 19.35, p \< .001) over the 4 week treatment period.,|ANOVA|||Repeated measures ANOVA with partial eta; accounts for multiple repeated measures over the course of treatment.||||<0.01
73823084|NCT00186485|147192239|SUPERIORITY_OR_OTHER||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the CGI scores (F (4,88) = 5.31, p \< .01) over the 4 week treatment period.|ANOVA|||Repeated Measures ANOVA with partial eta; p value was adjusted for multiple comparisons over the course of treatment||||<0.01
73823085|NCT00905424|147192240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.0902|TWO_SIDED|90.0|-4.5|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-4.5|0.0902
73823086|NCT00905424|147192241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.3091|TWO_SIDED|90.0|-2.4|0.6||The test was performed a priori at the significance level of 0.10|ANCOVA|||||0.6|-2.4|0.3091
73823087|NCT00905424|147192242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.0573|TWO_SIDED|90.0|-3.7|-0.3||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.3|-3.7|0.0573
73823088|NCT00905424|147192243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2368||95.0|||||Cochran-Mantel-Haenszel|||||||0.2368
73823089|NCT00905424|147192246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0||||0.0463|TWO_SIDED|90.0|-5.4|-0.5||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite||-0.5|-5.4|0.0463
73823090|NCT00905424|147192246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.1431|TWO_SIDED|90.0|-4.3|0.3||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index||0.3|-4.3|0.1431
73823091|NCT00905424|147192246|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.0281|TWO_SIDED|90.0|-5.8|-0.8||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index||-0.8|-5.8|0.0281
73823092|NCT00905424|147192247|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0||||0.092|TWO_SIDED|90.0|-6.0|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-6.0|0.0920
73823093|NCT00905424|147192248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0774|TWO_SIDED|90.0|-2.2|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-2.2|0.0774
73823094|NCT00905424|147192249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.4726|TWO_SIDED|90.0|-1.6|4.0||The test was performed a priori at the significance level of 0.10|ANCOVA|||||4.0|-1.6|0.4726
73823095|NCT00905424|147192250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.5182|TWO_SIDED|90.0|-1.4|3.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||3.1|-1.4|0.5182
73823096|NCT00905424|147192251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.463|TWO_SIDED|90.0|-3.1|1.2||The test was performed a priori at the significance level of 0.10|ANCOVA|||||1.2|-3.1|0.4630
73823097|NCT00905424|147192252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.523||95.0|||||Cochran-Mantel-Haenszel|||||||0.5230
73823098|NCT00905424|147192255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.2876|TWO_SIDED|90.0|-1.0|4.7||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite||4.7|-1.0|0.2876
73823099|NCT00905424|147192255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.559|TWO_SIDED|90.0|-2.1|4.4||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index||4.4|-2.1|0.5590
73823100|NCT00905424|147192255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.2079|TWO_SIDED|90.0|-0.7|5.2||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index||5.2|-0.7|0.2079
73823101|NCT00905424|147192256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.1489|TWO_SIDED|90.0|-8.0|0.5||The test was performed a priori at the significance level of 0.10|ANCOVA|||||0.5|-8.0|0.1489
73823102|NCT00905424|147192257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0852|TWO_SIDED|90.0|-2.8|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-2.8|0.0852
73823103|NCT00379899|147192258|SUPERIORITY_OR_OTHER|||||||0.073|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor (≥ 30 to 399, ≥ 400 to 999, and ≥ 1000)||||||0.073
73823104|NCT00379899|147192259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.094||95.0|0.36|1.08|||Cochran-Mantel-Haenszel||Logit estimates (Cinacalcet:Control)|||1.08|0.36|0.094
73823105|NCT00379899|147192260|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.018
73823106|NCT00379899|147192262|SUPERIORITY_OR_OTHER|||||||0.258|||||||Cochran-Mantel-Haenszel|||||||0.258
73823107|NCT00379899|147192263|SUPERIORITY_OR_OTHER|||||||0.011|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.011
73823108|NCT00379899|147192264|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
73823109|NCT00379899|147192265|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
73823110|NCT00379899|147192266|SUPERIORITY_OR_OTHER|||||||0.025|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.025
73823111|NCT00379899|147192267|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.021
73823112|NCT00379899|147192268|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
73823113|NCT00379899|147192269|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
73823114|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|0.64|||||TWO_SIDED|95.0|0.37|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.37|
73823115|NCT03311841|147192282|OTHER|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.77|2.31||||||Comparison of midazolam||2.31|0.77|
73823116|NCT03311841|147192282|OTHER|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|0.95|||||TWO_SIDED|95.0|0.56|1.62||||||Comparison of midazolam||1.62|0.56|
73823117|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|0.4|||||TWO_SIDED|95.0|0.23|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.70|0.23|
73823118|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|1.01|||||TWO_SIDED|95.0|0.53|1.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.93|0.53|
73823119|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|2.87|||||TWO_SIDED|95.0|1.51|5.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.47|1.51|
73823120|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|4.98|||||TWO_SIDED|95.0|2.62|9.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||9.48|2.62|
73823121|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|3.39|||||TWO_SIDED|95.0|1.78|6.44|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||6.44|1.78|
73823122|NCT03311841|147192282|OTHER|Comparison of pitavastatin|Geometric least squares mean ratio|1.32|||||TWO_SIDED|95.0|0.76|2.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.31|0.76|
73823123|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|1.96|||||TWO_SIDED|95.0|1.12|3.42|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.42|1.12|
73823124|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.73|2.13|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.13|0.73|
73823125|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.74|2.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.27|0.74|
73823126|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|1.05|||||TWO_SIDED|95.0|0.64|1.72|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.72|0.64|
73823127|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|1.45|||||TWO_SIDED|95.0|0.88|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.38|0.88|
73823128|NCT03311841|147192282|OTHER|Comparison of pitavastatin lactone|Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.68|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.76|0.68|
73823129|NCT03311841|147192282|OTHER|Comparison of pitavastatin lactone|Geometric least squares mean ratio|0.71|||||TWO_SIDED|95.0|0.43|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.17|0.43|
73823130|NCT03311841|147192282|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.53|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.41|0.53|
73823131|NCT03311841|147192282|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.89|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||3.46|0.89|
73823132|NCT03311841|147192282|OTHER||Geometric least squares mean ratio|1.63|||||TWO_SIDED|95.0|0.85|3.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.14|0.85|
73823133|NCT03311841|147192282|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.57|2.22|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.22|0.57|
73823134|NCT03311841|147192282|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.38|||||TWO_SIDED|95.0|0.76|2.49|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.49|0.76|
73823135|NCT03311841|147192282|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.31|||||TWO_SIDED|95.0|0.75|2.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.29|0.75|
73823136|NCT03311841|147192282|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.65|1.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.81|0.65|
73823137|NCT03311841|147192282|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|0.79|||||TWO_SIDED|95.0|0.46|1.33|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.33|0.46|
73823138|NCT03311841|147192282|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|0.9|||||TWO_SIDED|95.0|0.33|2.45|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.45|0.33|
73823139|NCT03311841|147192282|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|1.97|||||TWO_SIDED|95.0|0.75|5.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||5.14|0.75|
73823140|NCT03311841|147192282|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.49|3.16|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||3.16|0.49|
73823141|NCT03311841|147192282|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|0.71|||||TWO_SIDED|95.0|0.27|1.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.86|0.27|
73823142|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|0.67|||||TWO_SIDED|95.0|0.4|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.40|
73823143|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.26|||||TWO_SIDED|95.0|0.76|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||2.09|0.76|
73823144|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|0.93|||||TWO_SIDED|95.0|0.57|1.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.52|0.57|
73823145|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|0.42|||||TWO_SIDED|95.0|0.25|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.70|0.25|
73823146|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|0.96|||||TWO_SIDED|95.0|0.53|1.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.73|0.53|
73823147|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|2.38|||||TWO_SIDED|95.0|1.32|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||4.32|1.32|
73823148|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|3.09|||||TWO_SIDED|95.0|1.75|5.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.48|1.75|
73823149|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.8|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||2.64|0.80|
73823150|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.31|||||TWO_SIDED|95.0|0.78|2.2|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.20|0.78|
73823151|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.84|||||TWO_SIDED|95.0|1.09|3.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.09|1.09|
73823152|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.26|||||TWO_SIDED|95.0|0.77|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.09|0.77|
73823153|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.43|||||TWO_SIDED|95.0|0.85|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.40|0.85|
73823154|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.68|1.56|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.56|0.68|
73823155|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.27|||||TWO_SIDED|95.0|0.83|1.92|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.92|0.83|
73823156|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.73|1.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.63|0.73|
73823157|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|0.85|||||TWO_SIDED|95.0|0.56|1.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.29|0.56|
73823158|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.11|||||TWO_SIDED|95.0|0.55|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.23|0.55|
73823159|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.66|||||TWO_SIDED|95.0|0.89|3.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.11|0.89|
73823160|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.52|||||TWO_SIDED|95.0|0.83|2.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.77|0.83|
73823161|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.45|||||TWO_SIDED|95.0|0.78|2.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.71|0.78|
73823162|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.28|||||TWO_SIDED|95.0|0.7|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.34|0.70|
73823163|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.78|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.28|0.78|
73823164|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.62|1.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.74|0.62|
73823165|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.62|1.82|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.82|0.62|
73823166|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.58|2.67|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.67|0.58|
73823167|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|2.25|||||TWO_SIDED|95.0|1.09|4.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||4.63|1.09|
73823168|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.72|2.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.93|0.72|
73823169|NCT03311841|147192284|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.51|2.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.19|0.51|
73823170|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|0.63|||||TWO_SIDED|95.0|0.36|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.36|
73823171|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.75|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||2.28|0.75|
73823172|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.55|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.61|0.55|
73823173|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|0.4|||||TWO_SIDED|95.0|0.23|0.69|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.69|0.23|
73823174|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.02|||||TWO_SIDED|95.0|0.53|1.95|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.95|0.53|
73823175|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|3.0|||||TWO_SIDED|95.0|1.57|5.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.74|1.57|
73823176|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|5.28|||||TWO_SIDED|95.0|2.83|9.87|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||9.87|2.83|
73823177|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|2.65|||||TWO_SIDED|95.0|1.39|5.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.07|1.39|
73823178|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.76|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.34|0.76|
73823179|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.97|||||TWO_SIDED|95.0|1.12|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.46|1.12|
73823180|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.72|2.15|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.15|0.72|
73823181|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.34|||||TWO_SIDED|95.0|0.76|2.36|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.36|0.76|
73823182|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.64|1.65|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.65|0.64|
73823183|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.39|||||TWO_SIDED|95.0|0.87|2.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.24|0.87|
73823184|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.08|||||TWO_SIDED|95.0|0.68|1.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.71|0.68|
73823185|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|0.73|||||TWO_SIDED|95.0|0.45|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.17|0.45|
73823186|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.16|||||TWO_SIDED|95.0|0.53|2.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.52|0.53|
73823187|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.8|||||TWO_SIDED|95.0|0.9|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.62|0.90|
73823188|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.65|||||TWO_SIDED|95.0|0.84|3.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.23|0.84|
73823189|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.17|||||TWO_SIDED|95.0|0.58|2.35|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.35|0.58|
73823190|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.71|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.97|0.71|
73823191|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.68|||||TWO_SIDED|95.0|0.89|3.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||3.19|0.89|
73823192|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.16|||||TWO_SIDED|95.0|0.63|2.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.14|0.63|
73823193|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|0.83|||||TWO_SIDED|95.0|0.44|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.57|0.44|
73823194|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.27|||||TWO_SIDED|95.0|0.56|2.91|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.91|0.56|
73823195|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|2.65|||||TWO_SIDED|95.0|1.21|5.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||5.81|1.21|
73823196|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.7|3.18|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.18|0.70|
73823197|NCT03311841|147192285|OTHER||Geometric least squares mean ratio|0.95|||||TWO_SIDED|95.0|0.43|2.08|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.08|0.43|
73823198|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|0.97|||||TWO_SIDED|95.0|0.63|1.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.48|0.63|
73823199|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.69|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.62|0.69|
73823200|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.62|1.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.41|0.62|
73823201|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|0.55|||||TWO_SIDED|95.0|0.36|0.83|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.83|0.36|
73823202|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|0.84|||||TWO_SIDED|95.0|0.44|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.61|0.44|
73823203|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.71|||||TWO_SIDED|95.0|0.89|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||3.27|0.89|
73823204|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.93|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||3.27|0.93|
73823205|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|0.72|||||TWO_SIDED|95.0|0.38|1.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.38|0.38|
73823206|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.92|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.40|0.92|
73823207|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.84|||||TWO_SIDED|95.0|1.14|2.98|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.98|1.14|
73823208|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.84|2.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.11|0.84|
73823209|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.47|||||TWO_SIDED|95.0|0.91|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.38|0.91|
73823210|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.19|||||TWO_SIDED|95.0|0.81|1.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.75|0.81|
73823211|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.2|||||TWO_SIDED|95.0|0.82|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.76|0.82|
73823212|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.08|||||TWO_SIDED|95.0|0.75|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.57|0.75|
73823213|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|0.89|||||TWO_SIDED|95.0|0.61|1.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.31|0.61|
73823214|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.48|||||TWO_SIDED|95.0|0.58|3.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.75|0.58|
73823215|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|2.54|||||TWO_SIDED|95.0|1.11|5.85|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||5.85|1.11|
73823216|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|2.16|||||TWO_SIDED|95.0|0.97|4.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||4.81|0.97|
73823217|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|2.94|||||TWO_SIDED|95.0|1.28|6.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||6.77|1.28|
73823218|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.11|||||TWO_SIDED|95.0|0.59|2.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.07|0.59|
73823219|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.24|||||TWO_SIDED|95.0|0.71|2.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.17|0.71|
73823220|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.55|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.62|0.55|
73823221|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.12|||||TWO_SIDED|95.0|0.64|1.96|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.96|0.64|
73823222|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.1|||||TWO_SIDED|95.0|0.46|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.64|0.46|
73823223|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.87|||||TWO_SIDED|95.0|0.81|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||4.32|0.81|
73823224|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.51|2.53|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.53|0.51|
73823225|NCT03311841|147192286|OTHER||Geometric least squares mean ratio|1.04|||||TWO_SIDED|95.0|0.45|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.41|0.45|
73823226|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.68|||||TWO_SIDED|95.0|0.78|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||3.62|0.78|
73823227|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.75|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.23|0.75|
73823228|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.98|||||TWO_SIDED|95.0|1.15|3.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.41|1.15|
73823229|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|0.98|||||TWO_SIDED|95.0|0.58|1.66|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||1.66|0.58|
73823230|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.52|2.03|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.03|0.52|
73823231|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.51|||||TWO_SIDED|95.0|0.77|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.97|0.77|
73823232|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.07|||||TWO_SIDED|95.0|0.56|2.05|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.05|0.56|
73823233|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|0.6|||||TWO_SIDED|95.0|0.3|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.17|0.30|
73823234|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.57|||||TWO_SIDED|95.0|0.84|2.94|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin||2.94|0.84|
73823235|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.81|2.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin||2.73|0.81|
73823236|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.44|||||TWO_SIDED|95.0|0.84|2.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.47|0.84|
73823237|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.63|1.78|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.78|0.63|
73823238|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.85|||||TWO_SIDED|95.0|0.95|3.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.61|0.95|
73823239|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|3.1|||||TWO_SIDED|95.0|1.64|5.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||5.86|1.64|
73823240|NCT03311841|147192287|OTHER||Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.95|3.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.24|0.95|
73823241|NCT00627926|147192302|SUPERIORITY_OR_OTHER||Difference in percentage|23.0|||||TWO_SIDED|95.0|15.9|30.0||||||||30.0|15.9|
73823242|NCT00627926|147192302|SUPERIORITY_OR_OTHER||Difference in percentage|29.2|||||TWO_SIDED|95.0|22.4|36.1||||||||36.1|22.4|
73823243|NCT00627926|147192303|SUPERIORITY_OR_OTHER||Difference in percentage|57.1|||||TWO_SIDED|95.0|51.4|62.8||||||||62.8|51.4|
73823244|NCT00627926|147192303|SUPERIORITY_OR_OTHER||Difference in percentage|58.4|||||TWO_SIDED|95.0|52.7|64.0||||||||64.0|52.7|
73823245|NCT00627926|147192304|SUPERIORITY_OR_OTHER||Difference in percentage|48.8|||||TWO_SIDED|95.0|43.0|54.6||||||||54.6|43.0|
73823246|NCT00627926|147192304|SUPERIORITY_OR_OTHER||Difference in percentage|50.4|||||TWO_SIDED|95.0|44.6|56.2||||||||56.2|44.6|
73823247|NCT00627926|147192305|SUPERIORITY_OR_OTHER||Difference in percentage|35.7|||||TWO_SIDED|95.0|29.0|42.4||||||||42.4|29.0|
73823248|NCT00627926|147192305|SUPERIORITY_OR_OTHER||Difference in percentage|37.5|||||TWO_SIDED|95.0|30.9|44.1||||||||44.1|30.9|
73823249|NCT00627926|147192306|SUPERIORITY_OR_OTHER||Difference in percentage|17.6|||||TWO_SIDED|95.0|11.2|24.0||||||||24.0|11.2|
73823250|NCT00627926|147192306|SUPERIORITY_OR_OTHER||Difference in percentage|23.1|||||TWO_SIDED|95.0|17.0|29.2||||||||29.2|17.0|
73823251|NCT00627926|147192307|SUPERIORITY_OR_OTHER||Difference in percentage|25.5|||||TWO_SIDED|95.0|18.5|32.4||||||||32.4|18.5|
73823252|NCT00627926|147192307|SUPERIORITY_OR_OTHER||Difference in percentage|31.2|||||TWO_SIDED|95.0|24.4|37.9||||||||37.9|24.4|
73823253|NCT00627926|147192308|SUPERIORITY_OR_OTHER||Difference in percentage|25.2|||||TWO_SIDED|95.0|18.2|32.2||||||||32.2|18.2|
73823254|NCT00627926|147192308|SUPERIORITY_OR_OTHER||Difference in percentage|31.7|||||TWO_SIDED|95.0|24.9|38.5||||||||38.5|24.9|
73823255|NCT00627926|147192313|SUPERIORITY_OR_OTHER||Difference in percentage|24.9|||||TWO_SIDED|95.0|17.9|31.9||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).||31.9|17.9|
73823256|NCT00627926|147192313|SUPERIORITY_OR_OTHER||Difference in percentage|30.9|||||TWO_SIDED|95.0|24.1|37.7||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).||37.7|24.1|
73823257|NCT00627926|147192313|SUPERIORITY_OR_OTHER||Difference in percentage|25.7|||||TWO_SIDED|95.0|18.8|32.6||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.||32.6|18.8|
73823258|NCT00627926|147192313|SUPERIORITY_OR_OTHER||Difference in percentage|32.5|||||TWO_SIDED|95.0|25.9|39.2||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.||39.2|25.9|
73823259|NCT01852513|147192340|SUPERIORITY|||||||0.391|||||||t-test, 2 sided|||||||0.391
73823260|NCT01852513|147192341|SUPERIORITY|||||||0.789|||||||t-test, 2 sided|||||||0.789
73823261|NCT01852513|147192342|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||||||0.778
73823262|NCT01462110|147192347|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.234|STANDARD_ERROR_OF_MEAN|0.0211|<|0.001|TWO_SIDED|95.0|-0.276|-0.192|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.192|-0.276|<0.001
73823263|NCT01462110|147192348|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-1.232|STANDARD_ERROR_OF_MEAN|0.0806|<|0.001|TWO_SIDED|95.0|-1.392|-1.071|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-1.071|-1.392|<0.001
73823264|NCT01462110|147192349|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.106|STANDARD_ERROR_OF_MEAN|0.0173|<|0.001|TWO_SIDED|95.0|-0.14|-0.071|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.071|-0.140|<0.001
73823265|NCT01462110|147192350|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.0957|<|0.001|TWO_SIDED|95.0|-1.02|-0.639|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.639|-1.020|<0.001
73823266|NCT01462110|147192351|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.044|STANDARD_ERROR_OF_MEAN|0.0076|<|0.001|TWO_SIDED|95.0|-0.059|-0.029|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.029|-0.059|<0.001
73823267|NCT01462110|147192352|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.0087|<|0.001|TWO_SIDED|95.0|-0.078|-0.043|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.043|-0.078|<0.001
73823268|NCT02499120|147192391|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.18|TWO_SIDED|95.0|0.536|1.253||1-sided p-value was from the log-rank test stratified by stratification factors ECOG(Eastern Cooperative Oncology Group) per randomization.|Log Rank|||||1.253|0.536|0.1800
73823269|NCT02499120|147192392|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.4953|TWO_SIDED|95.0|0.669|1.495||1-sided p-value was from the log-rank test stratified by stratification factors ECOG per randomization.|Log Rank|||||1.495|0.669|0.4953
73823270|NCT01689441|147192406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.25
73823271|NCT01689441|147192407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.51
73823272|NCT01689441|147192408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.54
73823273|NCT04235504|147192478|SUPERIORITY||Mean Difference (Final Values)|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.1|||linear mixed model|||||-1.10|-1.74|<0.0001
73823274|NCT04235504|147192479|SUPERIORITY||Mean Difference (Final Values)|27.59|||<|0.0001|TWO_SIDED|95.0|21.59|33.6|||linear mixed model|||||33.60|21.59|<0.0001
73823275|NCT04235504|147192480|SUPERIORITY||Mean Difference (Final Values)|-27.86|||<|0.0001|TWO_SIDED|95.0|-34.16|-21.55|||linear mixed model|||||-21.55|-34.16|<0.0001
73823276|NCT04235504|147192481|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.6227|TWO_SIDED|95.0|-0.37|0.61|||linear mixed model|||||0.61|-0.37|0.6227
73823277|NCT04235504|147192482|SUPERIORITY||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-2.17|0.0||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||0.00|-2.17|
73823278|NCT04235504|147192483|SUPERIORITY||Mean Difference (Final Values)|28.81|||||TWO_SIDED|95.0|12.34|45.28||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||45.28|12.34|
73823279|NCT04235504|147192484|SUPERIORITY||Mean Difference (Final Values)|-28.45|||||TWO_SIDED|95.0|-45.27|-11.64||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||-11.64|-45.27|
73823280|NCT04235504|147192485|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.32|0.59||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||0.59|-1.32|
73823281|NCT00870467|147192492|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73823282|NCT00870467|147192493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73823283|NCT00870467|147192494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73823284|NCT00870467|147192495|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73823285|NCT00870467|147192496|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73823286|NCT00870467|147192497|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73823287|NCT02106351|147192506|SUPERIORITY||LS mean difference back transformed|-0.4||||0.0118|TWO_SIDED|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of covariance (ANCOVA) on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived least squares (LS) means were back transformed to the original scale and the treatment difference determined.||||0.0118
73823288|NCT02106351|147192506|SUPERIORITY||LS mean difference back transformed|-0.7|||<|0.0001|TWO_SIDED|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANCOVA on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||<0.0001
73823289|NCT02106351|147192507|SUPERIORITY||LS mean difference back transformed|0.2||||0.2043|TWO_SIDED|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of variance (ANOVA) on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||0.2043
73896532|NCT03456882|147326403|SUPERIORITY|||||||0.2738||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.2738
73823290|NCT02106351|147192507|SUPERIORITY||LS mean difference back transformed|0.2||||0.188|TWO_SIDED|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANOVA on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||0.1880
73823291|NCT02106351|147192508|SUPERIORITY||LS mean difference|0.5||||0.7648|TWO_SIDED|95.0|-2.7|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.||3.7|-2.7|0.7648
73823292|NCT02106351|147192508|SUPERIORITY||LS mean difference|0.5||||0.7429|TWO_SIDED|95.0|-2.6|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.||3.7|-2.6|0.7429
73823293|NCT00069823|147192529|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.2||||0.35|TWO_SIDED|95.0|0.8|2.0||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||2.0|0.8|0.35
73823294|NCT00069823|147192530|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.79|TWO_SIDED|95.0|0.6|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.5|0.6|0.79
73823295|NCT00069823|147192531|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.1||||0.66|TWO_SIDED|95.0|0.8|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||The rates of EPACs were compared using incidence-rate ratios (IRR). IRR and P value were estimated with the use of negative binomial regression models with robust variance estimates.||1.5|0.8|0.66
73823296|NCT00069823|147192532|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.62|TWO_SIDED|95.0|0.6|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.6|0.62
73823297|NCT00069823|147192533|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.0||||0.87|TWO_SIDED|95.0|0.8|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.8|0.87
73823298|NCT00069823|147192534|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.62||95.0|0.7|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.7|0.62
73823299|NCT00069823|147192535|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.7|TWO_SIDED|95.0|0.6|1.4||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.4|0.6|0.70
73823300|NCT00069823|147192536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.36|TWO_SIDED|95.0|-0.03|0.08||P values were calculated with the use of linear regression.|Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group, e.g. 0.00 - (-0.02) = -0.03 (rounding)|The treatment effect is the mean change in the Esomeprazole group - mean change in placebo group||0.08|-0.03|0.36
73823301|NCT00069823|147192537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3|TWO_SIDED|95.0|-0.03|0.09|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.09|-0.03|0.30
73823302|NCT00069823|147192538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|5.1||0.24|TWO_SIDED|95.0|-4.0|16.0|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||16.0|-4.0|0.24
73823303|NCT00069823|147192539|SUPERIORITY_OR_OTHER||Treatment Effect|-1.8||||0.04||95.0|-3.6|-0.1|||Regression, Linear|||||-0.1|-3.6|0.04
73823304|NCT00069823|147192540|SUPERIORITY_OR_OTHER||Treatment Effect|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|0.0|0.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.2|0.0|0.11
73823305|NCT00069823|147192541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.11|TWO_SIDED|95.0|-0.05|-0.02|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||-0.02|-0.05|0.11
73823306|NCT00069823|147192542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.33|TWO_SIDED|95.0|-0.2|0.1|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.1|-0.2|0.33
73823307|NCT00069823|147192543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.16|TWO_SIDED|95.0|-2.0|0.4|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.4|-2.0|0.16
73823308|NCT00069823|147192544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.78||0.56|TWO_SIDED|95.0|-1.1|2.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||2.2|-1.1|0.56
73823309|NCT00069823|147192545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.76|TWO_SIDED|95.0|-0.05|0.07|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.07|-0.05|0.76
73823310|NCT00069823|147192546|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.39|TWO_SIDED|95.0|-0.8|0.3|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.3|-0.8|0.39
73823311|NCT00520039|147192547|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.09|STANDARD_ERROR_OF_MEAN|0.94||0.02|TWO_SIDED|95.0|0.15|2.03|||Chi-squared|df = 1|The denominator of the Odds ratio represents the odds of improvement for the Standard Care Only (SCO) group.|Test of the null hypothesis that there is no improvement in MEE at Visit 3 using tympanogram.||2.03|0.15|0.02
73823312|NCT00520039|147192548|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|1.31||0.32|TWO_SIDED|95.0|-1.0|1.62|||Chi-squared|df = 1|The odds of Resolution of MEE before OMT is represented in the denominator of the odds ratio|||1.62|-1.00|0.32
73823313|NCT00520039|147192549|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.25|STANDARD_ERROR_OF_MEAN|1.03||0.31|TWO_SIDED|95.0|-0.78|1.28|||Chi-squared|df = 1||||1.28|-0.78|.31
73823314|NCT01801111|147192557|OTHER|||||||0.0005|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the objective response rate (ORR) is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0005
73823315|NCT01801111|147192558|OTHER|||||||0.0599|TWO_SIDED||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0599
73823316|NCT01801111|147192560|OTHER|||||||0.0001|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0001
73823317|NCT01223937|147192595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.028|TWO_SIDED|95.0|-0.42|-0.02||A priori threshold for significance was p\<=0.05.|ANCOVA|Repeated measures ANCOVA with treatment, visit (including a treatment-by-visit interaction term), and age stratification (\<65, ≥65 years) as factors.||"The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.02|-0.42|0.0280
73823318|NCT01223937|147192596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.0061|TWO_SIDED|95.0|1.19|2.86||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method with treatment, visit (including a treatment-by-visit interaction term), and age stratification (\<65, ≥65 years) as factors.||The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.||2.86|1.19|0.0061
73823319|NCT01223937|147192597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0104|TWO_SIDED|95.0|-0.54|-0.07||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids, using last observation carried forward.||Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.||-0.07|-0.54|0.0104
73823320|NCT01223937|147192598|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0586|TWO_SIDED|95.0|0.98|3.05||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||||3.05|0.98|0.0586
73823321|NCT01223937|147192599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.03||||0.0034|TWO_SIDED|95.0|16.35|81.7||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void, using last observation carried forward.||||81.70|16.35|0.0034
73823322|NCT01223937|147192600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.56||||0.0031|TWO_SIDED|95.0|-138.74|-28.38||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume, using last observation carried forward.||||-28.38|-138.74|0.0031
73823323|NCT01223937|147192601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.91||||0.1829|TWO_SIDED|95.0|-180.42|34.6||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume, using last observation carried forward.||||34.60|-180.42|0.1829
73823324|NCT03284853|147192619|OTHER|The primary analysis was performed on the ITT population with imputation by Markov Chain Monte Carlo method.|||||<|0.05||||||Linear model with IOP at the given visit and time point as the response, baseline IOP as a covariate, and treatment as a main effect factor at each time point (08:00, 10:00, and 16:00 hours at the Week 2, Week 6, and Month 3 Visits).|Regression, Linear|Non-inferiority for PG324 was concluded if the UL of the 95% CI was ≤ l.5 mmHg at all 9 time points and ≤ l.0 mmHg at the majority of time points||Assuming no difference between PG324 and Ganfort, a two-tailed alpha of 0.05 (2-sided 95% CI) at each of 9 time points, a common SD of 3.5 mmHg, and a correlation between time points of ≤ 0.60, 200 ITT subjects per arm were necessary to have 85% power to show clinical non-inferiority of PG324 to Ganfort in the mean change from baseline IOP.||||<0.05
73823325|NCT01043133|147192647|SUPERIORITY_OR_OTHER||log-binomial|3.97|STANDARD_ERROR_OF_MEAN|3.97||0.01|TWO_SIDED|95.0|1.34|11.79|||log-binomial regression||Robust Huber-White standard errors account for clustering|||11.79|1.34|.01
73823326|NCT01043133|147192648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_DEVIATION|2.78||0.05|TWO_SIDED|95.0|-2.48|-0.03|||ANCOVA|||||-.03|-2.48|.05
73823327|NCT00255164|147192661|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
73823328|NCT00255164|147192661|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
73823329|NCT00255164|147192661|SUPERIORITY_OR_OTHER|||||||0.80473||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.80473
73823330|NCT00255164|147192662|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
73823331|NCT00255164|147192662|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
73823332|NCT00255164|147192662|SUPERIORITY_OR_OTHER|||||||0.76046||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.76046
73823333|NCT00255164|147192664|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
73823334|NCT00255164|147192664|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
73823335|NCT00255164|147192664|SUPERIORITY_OR_OTHER|||||||0.37161||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.37161
73823336|NCT00255164|147192665|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
73823337|NCT00255164|147192665|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
73823338|NCT00255164|147192665|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.59700
73823339|NCT03782987|147192698|OTHER||Geometric mean (gMean) ratio (%) (T/ R)|649.48|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|541.29|779.29|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||779.29|541.29|
73823340|NCT03782987|147192699|OTHER||gMean ratio (%) (T/ R)|166.88|STANDARD_ERROR_OF_MEAN|17.7|||TWO_SIDED|90.0|148.42|187.64|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||187.64|148.42|
73823341|NCT03782987|147192700|OTHER||gMean ratio (%) (T/ R)|931.41|STANDARD_ERROR_OF_MEAN|25.9|||TWO_SIDED|90.0|785.19|1104.85|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||1104.85|785.19|
73823342|NCT01877668|147192713|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.13|STANDARD_ERROR_OF_MEAN|6.67||0.0102|TWO_SIDED|95.0|4.06|30.21|||Large sample approximation|Missing response (MR)=non-response (NR)||||30.21|4.06|0.0102
73823343|NCT01877668|147192713|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.24|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|14.22|40.26|||Large sample approximation|MR=NR||||40.26|14.22|<0.0001
73823344|NCT01877668|147192713|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.55|STANDARD_ERROR_OF_MEAN|6.69||0.0055|TWO_SIDED|95.0|5.45|31.66|||Large sample approximation|MR=NR||||31.66|5.45|0.0055
73823345|NCT01877668|147192714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1697|STANDARD_ERROR_OF_MEAN|0.06173||0.0062|TWO_SIDED|95.0|-0.291|-0.0483|||Mixed Models Analysis|No imputation.||||-0.0483|-0.2910|0.0062
73823346|NCT01877668|147192714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2196|STANDARD_ERROR_OF_MEAN|0.06184||0.0004|TWO_SIDED|95.0|-0.3411|-0.098|||Mixed Models Analysis|No imputation.||||-0.0980|-0.3411|0.0004
73823347|NCT01877668|147192714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2005|STANDARD_ERROR_OF_MEAN|0.06145||0.0012|TWO_SIDED|95.0|-0.3213|-0.0797|||Mixed Models Analysis|No imputation.||||-0.0797|-0.3213|0.0012
73823348|NCT00814138|147192773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-488.0||||0.26|TWO_SIDED|95.0|-2443.4|1467.3|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||1467.3|-2443.4|0.26
73823349|NCT00814138|147192774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.26|TWO_SIDED|95.0|-9.7|5.8|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||5.8|-9.7|0.26
73823350|NCT00814138|147192775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.29|TWO_SIDED|95.0|-4.9|1.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||1.5|-4.9|0.29
73823351|NCT00814138|147192776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.28|TWO_SIDED|95.0|-6.3|1.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||1.8|-6.3|0.28
73823352|NCT00814138|147192777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.82|TWO_SIDED|95.0|-7.2|5.4|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||5.4|-7.2|0.82
73823353|NCT00814138|147192778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.21|TWO_SIDED|95.0|-3.7|0.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||0.8|-3.7|0.21
73823354|NCT00814138|147192779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.09|TWO_SIDED|95.0|-7.1|0.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||0.5|-7.1|0.09
73823355|NCT00583908|147192783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.5|STANDARD_DEVIATION|17.1|<|0.0001||95.0||||Paired t-test|t-test, 1 sided||mean difference was senofilcon A minus balafilcon A|Alternative Hypothesis was senofilcon A toric was superior to balafilcon A toric by having less degrees of rotation||||<0.0001
73823356|NCT00583908|147192783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|STANDARD_DEVIATION|17.8||0.0002||95.0||||paired t-test|t-test, 1 sided||mean difference is senofilcon A minus lotrafilcon B|Hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having less degree of rotation||||0.0002
73823357|NCT00583908|147192783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.0|STANDARD_DEVIATION|12.4|<|0.0001||95.0||||paired t-test|t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|Hypothesis was senofilcon A toric was superior to omafilcon A toric by having less degree of rotation||||<0.0001
73823358|NCT00583908|147192784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.15||0.0083||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus balafilcon A|Alternative hypothesis was senofilcon A toric was superior to balafilcon A toric by having a lower logMAR score||||0.0083
73823359|NCT00583908|147192784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.09||0.052||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus lotrafilcon B|Alternative hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having a lower logMAR score||||0.052
73823360|NCT00583908|147192784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.14||0.015||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A|Alternative hypothesis was senofilcon A toric was superior to omafilcon A toric by having a lower logMAR score||||0.015
73823361|NCT00583908|147192785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_DEVIATION|6.5||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.16
73823362|NCT00583908|147192785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|3.5||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.73
73823363|NCT00583908|147192785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_DEVIATION|4.4||0.044||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A|||||0.044
73823364|NCT00583908|147192786|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.1|STANDARD_DEVIATION|5.0||0.044||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.044
73823365|NCT00583908|147192786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|4.7||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.31
73823366|NCT00583908|147192786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_DEVIATION|5.9||0.44||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.44
73823367|NCT00583908|147192787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|6.5||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.78
73823368|NCT00583908|147192787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|6.3||0.68||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.68
73823369|NCT00583908|147192787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|7.6||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.78
73823370|NCT00583908|147192788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|6.5||0.11||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.11
73823371|NCT00583908|147192788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|4.3||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.31
73823372|NCT00583908|147192788|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0|STANDARD_DEVIATION|6.3||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.16
73823373|NCT00583908|147192789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_DEVIATION|6.8||0.061||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.061
73823374|NCT00583908|147192789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|3.9||0.47||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.47
73823375|NCT00583908|147192789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_DEVIATION|3.6||0.38||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.38
73823376|NCT00583908|147192790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_DEVIATION|3.5||0.17||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.17
73823377|NCT00583908|147192790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|5.0||0.89||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.89
73823378|NCT00583908|147192790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|5.8||0.56||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.56
73823379|NCT00583908|147192791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_DEVIATION|6.8||0.008||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.0080
73823380|NCT00583908|147192791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_DEVIATION|3.1||0.0049||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.0049
73823381|NCT00583908|147192791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_DEVIATION|5.6||0.0058||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.0058
73823382|NCT00583908|147192792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|3.7||0.27||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.27
73823383|NCT00583908|147192792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|6.0||0.85||95.0|||||t-test, 1 sided||Mean difference is senofilocon A minus lotrafilcon B|||||0.85
73823384|NCT00583908|147192792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|2.6||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omifilcon A|||||0.73
73823385|NCT03286218|147192806|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 14 mm.|Least Squares (LS) Mean Difference|32.4|||||TWO_SIDED|90.0|28.4|36.4||||||||36.4|28.4|
73823386|NCT03286218|147192806|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|15.6|||||TWO_SIDED|90.0|11.7|19.6||||||||19.6|11.7|
73823387|NCT03286218|147192806|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|20.3|||||TWO_SIDED|90.0|16.3|24.3||||||||24.3|16.3|
73823388|NCT03286218|147192806|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|23.6|||||TWO_SIDED|90.0|19.6|27.6||||||||27.6|19.6|
73823389|NCT03286218|147192806|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 100 mg dose is 5 mm.|LS Mean Difference|16.8|||||TWO_SIDED|90.0|12.8|20.8||||||||20.8|12.8|
73823390|NCT03286218|147192806|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 200 mg dose is 5 mm.|LS Mean Difference|12.1|||||TWO_SIDED|90.0|8.1|16.1||||||||16.1|8.10|
73823391|NCT03286218|147192806|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 400 mg dose is 5 mm.|LS Mean Difference|8.79|||||TWO_SIDED|90.0|4.8|12.8||||||||12.8|4.8|
73823392|NCT03286218|147192809|OTHER||LS Mean Difference|33.1|||||TWO_SIDED|90.0|28.5|37.7||||||Overall Drug Liking||37.7|28.5|
73823393|NCT03286218|147192809|OTHER||LS Mean Difference|18.6|||||TWO_SIDED|90.0|14.0|23.2||||||Overall Drug Liking||23.2|14.0|
73823394|NCT03286218|147192809|OTHER||LS Mean Difference|19.1|||||TWO_SIDED|90.0|14.5|23.8||||||Overall Drug Liking||23.8|14.5|
73823395|NCT03286218|147192809|OTHER||LS Mean Difference|24.3|||||TWO_SIDED|90.0|19.7|28.9||||||Overall Drug Liking||28.9|19.7|
73823396|NCT03286218|147192809|OTHER||LS Mean Difference|34.0|||||TWO_SIDED|90.0|29.1|38.9||||||Take drug again||38.9|29.1|
73823397|NCT03286218|147192809|OTHER||LS Mean Difference|19.1|||||TWO_SIDED|90.0|14.2|24.0||||||Take drug again||24.0|14.2|
73823398|NCT03286218|147192809|OTHER||LS Mean Difference|20.6|||||TWO_SIDED|90.0|15.7|25.6||||||Take drug again||25.6|15.7|
73823399|NCT03286218|147192809|OTHER||LS Mean Difference|25.3|||||TWO_SIDED|90.0|20.3|30.2||||||Take drug again||30.2|20.3|
73823400|NCT03286218|147192809|OTHER||LS Mean Difference|69.7|||||TWO_SIDED|90.0|62.1|77.4||||||Good effects||77.4|62.1|
73823401|NCT03286218|147192809|OTHER||LS Mean Difference|35.5|||||TWO_SIDED|90.0|27.9|43.2||||||Good effects||43.2|27.9|
73823402|NCT03286218|147192809|OTHER||LS Mean Difference|52.0|||||TWO_SIDED|90.0|44.4|59.7||||||Good effects||59.7|44.4|
73823403|NCT03286218|147192809|OTHER||LS Mean Difference|53.0|||||TWO_SIDED|90.0|45.4|60.6||||||Good effects||60.6|45.4|
73823404|NCT03286218|147192809|OTHER||LS Mean Difference|20.4|||||TWO_SIDED|90.0|13.6|27.2||||||Bad effects||27.2|13.6|
73823405|NCT03286218|147192809|OTHER||LS Mean Difference|5.04|||||TWO_SIDED|90.0|-1.76|11.8||||||Bad effects||11.8|-1.76|
73823406|NCT03286218|147192809|OTHER||LS Mean Difference|7.28|||||TWO_SIDED|90.0|0.487|14.1||||||Bad effects||14.1|0.487|
73823407|NCT03286218|147192809|OTHER||LS Mean Difference|12.5|||||TWO_SIDED|90.0|5.69|19.3||||||Bad effects||19.3|5.69|
73823408|NCT03286218|147192809|OTHER||LS Mean Difference|75.4|||||TWO_SIDED|90.0|67.2|83.5||||||Any effects||83.5|67.2|
73823409|NCT03286218|147192809|OTHER||LS Mean Difference|44.9|||||TWO_SIDED|90.0|36.8|53.0||||||Any effects||53.0|36.8|
73823410|NCT03286218|147192809|OTHER||LS Mean Difference|56.8|||||TWO_SIDED|90.0|48.7|64.9||||||Any effects||64.9|48.7|
73823411|NCT03286218|147192809|OTHER||LS Mean Difference|64.8|||||TWO_SIDED|90.0|56.7|73.0||||||Any effects||73.0|56.7|
73823412|NCT03286218|147192809|OTHER||LS Mean Difference|68.6|||||TWO_SIDED|90.0|60.6|76.6||||||High||76.6|60.6|
73823413|NCT03286218|147192809|OTHER||LS Mean Difference|34.4|||||TWO_SIDED|90.0|26.4|42.4||||||High||42.4|26.4|
73823414|NCT03286218|147192809|OTHER||LS Mean Difference|47.5|||||TWO_SIDED|90.0|39.5|55.5||||||High||55.5|39.5|
73823415|NCT03286218|147192809|OTHER||LS Mean Difference|58.4|||||TWO_SIDED|90.0|50.4|66.3||||||High||66.3|50.4|
73823416|NCT03286218|147192810|SUPERIORITY||Mean Difference (Final Values)|0.0|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73823417|NCT03286218|147192810|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0781|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0781
73823418|NCT03286218|147192810|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0625|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0625
73823419|NCT03286218|147192810|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0098|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0098
73823420|NCT03286218|147192811|OTHER||LS Mean Difference|-29.9|||||TWO_SIDED|90.0|-34.0|-25.9||||||Alertness/drowsiness||-25.9|-34.0|
73823421|NCT03286218|147192811|OTHER||LS Mean Difference|-16.9|||||TWO_SIDED|90.0|-20.9|-12.8||||||Alertness/drowsiness||-12.8|-20.9|
73823422|NCT03286218|147192811|OTHER||LS Mean Difference|-19.6|||||TWO_SIDED|90.0|-23.6|-15.5||||||Alertness/drowsiness||-15.5|-23.6|
73823423|NCT03286218|147192811|OTHER||LS Mean Difference|-24.8|||||TWO_SIDED|90.0|-28.8|-20.8||||||Alertness/drowsiness||-20.8|-28.8|
73823424|NCT03286218|147192811|OTHER||LS Mean Difference|-30.8|||||TWO_SIDED|90.0|-35.0|-26.5||||||Agitation/relaxation||-26.5|-35.0|
73823425|NCT03286218|147192811|OTHER||LS Mean Difference|-19.5|||||TWO_SIDED|90.0|-23.7|-15.3||||||Agitation/relaxation||-15.3|-23.7|
73823426|NCT03286218|147192811|OTHER||LS Mean Difference|-21.7|||||TWO_SIDED|90.0|-25.9|-17.5||||||Agitation/relaxation||-17.5|-25.9|
73823427|NCT03286218|147192811|OTHER||LS Mean Difference|-28.8|||||TWO_SIDED|90.0|-33.0|-24.5||||||Agitation/relaxation||-24.5|-33.0|
73823428|NCT02762084|147192834|OTHER|Pairwise comparison||||||0.03|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26||||0.030
73823429|NCT02762084|147192834|OTHER|Pairwise comparison||||||0.756|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26||||0.756
73823430|NCT02762084|147192835|OTHER|Pairwise comparison||||||0.5|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6||||0.500
73823431|NCT02762084|147192835|OTHER|Pairwise comparison||||||0.681|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6||||0.681
73823432|NCT02762084|147192839|OTHER|One-sided comparison||||||0.048|||||||Mann Whitey U|||at Week 26||||0.048
73823433|NCT02762084|147192839|OTHER|Two-sided comparison||||||0.096|||||||Mann Whitey U|||at Week 26||||0.096
73823434|NCT02762084|147192840|OTHER|Two-sided comparison||||||0.008|||||||Mann Whitey U|||at Week 26||||0.008
73823435|NCT01765296|147192861|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The SD for the primary efficacy outcome measure (WOMAC-Pain Subscale in the index joint) has been assumed to be 11 units. A 10% between-group difference was chosen as the non-inferiority margin for this study. The following parameters were used to calculate the sample size needed for this non-inferiority study.~* Level of significance, α = 0.025(one-sided)~* Statistical power, 1-β = 0.95~* Difference between test group and comparison group, Δ=0, δ (\>0) = non-inferiority margin"||||||0.011|||||||ANCOVA|||The primary efficacy outcome measure is the change in the WOMAC-Pain Subscale in the index joint at Week 6 vs. pre-dose Baseline and was analyzed using a mixed effect ANCOVA. Statistical tests to determine superiority between two treatment arms, CG100649 2 mg and placebo, are two-sided, and Non-inferiority between two treatment arms, CG100649 2 mg and celecoxib 200 mg is based on a one-sided 97.5% confidence interval of the difference.||||0.011
73823436|NCT01765296|147192861|NON_INFERIORITY|"The SD for the primary efficacy outcome measure (WOMAC-Pain Subscale in the index joint) has been assumed to be 11 units. A 10% between-group difference was chosen as the non-inferiority margin for this study. The following parameters were used to calculate the sample size needed for this non-inferiority study.~* Level of significance, α = 0.025(one-sided)~* Statistical power, 1-β = 0.95~* Difference between test group and comparison group, Δ=0, δ (\>0) = non-inferiority margin"||||||0.425|||||||ANCOVA|||||||0.425
73823437|NCT01619852|147192863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||.19
73823438|NCT01619852|147192864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
73823439|NCT01619852|147192865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
73823440|NCT01619852|147192865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-Sensory-discriminative dimension||||0.69
73823441|NCT01619852|147192865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-affective dimension||||0.75
73823442|NCT01619852|147192865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Brief Pain Inventory||||0.81
73823443|NCT01619852|147192866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||.19
73823444|NCT01619852|147192867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.29
73823445|NCT03933449|147192868|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0015|TWO_SIDED|95.0|0.36|0.82||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.82|0.36|0.0015
73823446|NCT03933449|147192869|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.0008|TWO_SIDED|95.0|0.17|0.69||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.69|0.17|0.0008
73823447|NCT03933449|147192870|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0021|TWO_SIDED|95.0|0.37|0.83||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.83|0.37|0.0021
73823448|NCT03933449|147192871|SUPERIORITY||Difference in Percentages|12.9||||0.0084|TWO_SIDED|95.0|2.7|24.5||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||24.5|2.7|0.0084
73823449|NCT03933449|147192872|SUPERIORITY||Difference in Percentages|17.1||||0.0403|TWO_SIDED|95.0|-2.3|38.0||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||38.0|-2.3|0.0403
73823450|NCT03933449|147192873|SUPERIORITY||Difference in Percentages|13.3||||0.0083|TWO_SIDED|95.0|2.8|25.2||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||25.2|2.8|0.0083
73823451|NCT03933449|147192874|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.177|TWO_SIDED|95.0|0.58|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.23|0.58|0.177
73823452|NCT03933449|147192875|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.238|TWO_SIDED|95.0|0.44|1.46||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.46|0.44|0.238
73823453|NCT03933449|147192876|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.171|TWO_SIDED|95.0|0.57|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.23|0.57|0.171
73823454|NCT03428100|147192908|SUPERIORITY||Odds Ratio (OR)|1.78||||0.071|TWO_SIDED|95.0|0.95|3.32|||Regression, Logistic|||||3.32|0.95|0.071
73823455|NCT03428100|147192908|SUPERIORITY||Odds Ratio (OR)|2.15||||0.031|TWO_SIDED|95.0|1.07|4.3|||Regression, Logistic|||||4.30|1.07|0.031
73823456|NCT03428100|147192909|SUPERIORITY||Odds Ratio (OR)|1.34||||0.427|TWO_SIDED|95.0|0.65|2.77|||Regression, Logistic|||||2.77|0.65|0.427
73823457|NCT03428100|147192910|SUPERIORITY||Odds Ratio (OR)|1.35||||0.513|TWO_SIDED|95.0|0.55|3.35|||Regression, Logistic|||||3.35|0.55|0.513
73823458|NCT03428100|147192910|SUPERIORITY||Odds Ratio (OR)|1.6||||0.242|TWO_SIDED|95.0|0.73|3.53|||Regression, Logistic|||||3.53|0.73|0.242
73823459|NCT03428100|147192910|SUPERIORITY||Odds Ratio (OR)|2.54||||0.03|TWO_SIDED|95.0|1.09|5.9|||Regression, Logistic|||||5.90|1.09|0.030
73823460|NCT03428100|147192911|SUPERIORITY||Odds Ratio (OR)|1.32||||0.611|TWO_SIDED|95.0|0.45|3.83|||Regression, Logistic|||||3.83|0.45|0.611
73823461|NCT03428100|147192911|SUPERIORITY||Odds Ratio (OR)|1.59||||0.325|TWO_SIDED|95.0|0.63|3.99|||Regression, Logistic|||||3.99|0.63|0.325
73823462|NCT03428100|147192911|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1|TWO_SIDED|95.0|0.85|6.14|||Regression, Logistic|||||6.14|0.85|0.100
73823463|NCT03428100|147192912|SUPERIORITY||Mean Difference (Final Values)|-17.65|STANDARD_ERROR_OF_MEAN|5.627||0.002|TWO_SIDED|95.0|-28.71|-6.58|||Mixed Models Analysis|||||-6.58|-28.71|0.002
73823464|NCT03428100|147192912|SUPERIORITY||Mean Difference (Final Values)|-13.35|STANDARD_ERROR_OF_MEAN|4.82||0.006|TWO_SIDED|95.0|-22.83|-3.87|||Mixed Models Analysis|||||-3.87|-22.83|0.006
73823465|NCT03428100|147192912|SUPERIORITY||Mean Difference (Final Values)|-20.62|STANDARD_ERROR_OF_MEAN|5.554||0.0002|TWO_SIDED|95.0|-31.54|-9.7|||Mixed Models Analysis|||||-9.70|-31.54|0.0002
73823466|NCT03428100|147192913|SUPERIORITY||Odds Ratio (OR)|4.14||||0.115|TWO_SIDED|95.0|0.71|24.29|||Regression, Logistic|||||24.29|0.71|0.115
73823467|NCT03428100|147192913|SUPERIORITY||Odds Ratio (OR)|5.85||||0.037|TWO_SIDED|95.0|1.11|30.88|||Regression, Logistic|||||30.88|1.11|0.037
73823468|NCT03428100|147192913|SUPERIORITY||Odds Ratio (OR)|4.78||||0.083|TWO_SIDED|95.0|0.81|28.08|||Regression, Logistic|||||28.08|0.81|0.083
73823469|NCT03428100|147192914|SUPERIORITY||Odds Ratio (OR)|3.28||||0.012|TWO_SIDED|95.0|1.29|8.32|||Regression, Logistic|||||8.32|1.29|0.012
73823470|NCT03428100|147192914|SUPERIORITY||Odds Ratio (OR)|3.71||||0.002|TWO_SIDED|95.0|1.59|8.66|||Regression, Logistic|||||8.66|1.59|0.002
73823471|NCT03428100|147192914|SUPERIORITY||Odds Ratio (OR)|6.85||||2e-05|TWO_SIDED|95.0|2.79|16.82|||Regression, Logistic|||||16.82|2.79|0.00002
73823472|NCT03428100|147192915|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.203||0.039|TWO_SIDED|95.0|-0.82|-0.02|||Mixed Models Analysis|||||-0.02|-0.82|0.039
73823473|NCT03428100|147192915|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.175||0.23|TWO_SIDED|95.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.23
73823474|NCT03428100|147192915|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.201||0.0001|TWO_SIDED|95.0|-1.18|-0.39|||Mixed Models Analysis|||||-0.39|-1.18|0.0001
73823475|NCT03428100|147192916|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.388||0.0714|TWO_SIDED|95.0|-1.47|0.06|||Mixed Models Analysis|||||0.06|-1.47|0.0714
73823476|NCT03428100|147192916|SUPERIORITY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.337||0.0134|TWO_SIDED|95.0|-1.5|-0.17|||Mixed Models Analysis|||||-0.17|-1.50|0.0134
73823477|NCT03428100|147192916|SUPERIORITY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.386||0.0002|TWO_SIDED|95.0|-2.21|-0.69|||Mixed Models Analysis|||||-0.69|-2.21|0.0002
73823478|NCT03428100|147192917|SUPERIORITY||Odds Ratio (OR)|1.71||||0.183|TWO_SIDED|95.0|0.78|3.75|||Regression, Logistic|||||3.75|0.78|0.183
73823479|NCT03428100|147192917|SUPERIORITY||Odds Ratio (OR)|1.54||||0.235|TWO_SIDED|95.0|0.76|3.11|||Regression, Logistic|||||3.11|0.76|0.235
73823480|NCT03428100|147192917|SUPERIORITY||Odds Ratio (OR)|1.01||||0.991|TWO_SIDED|95.0|0.43|2.36|||Regression, Logistic|||||2.36|0.43|0.991
73823481|NCT03428100|147192918|SUPERIORITY||Odds Ratio (OR)|1.41||||0.263|TWO_SIDED|95.0|0.77|2.57|||Regression, Logistic|||||2.57|0.77|0.263
73823482|NCT03428100|147192918|SUPERIORITY||Odds Ratio (OR)|1.89||||0.016|TWO_SIDED|95.0|1.13|3.19|||Regression, Logistic|||||3.19|1.13|0.016
73823483|NCT03428100|147192918|SUPERIORITY||Odds Ratio (OR)|1.93||||0.031|TWO_SIDED|95.0|1.06|3.52|||Regression, Logistic|||||3.52|1.06|0.031
73823484|NCT03428100|147192919|SUPERIORITY||Odds Ratio (OR)|1.97||||0.058|TWO_SIDED|95.0|0.98|3.96|||Regression, Logistic|||||3.96|0.98|0.058
73823485|NCT03428100|147192919|SUPERIORITY||Odds Ratio (OR)|1.77||||0.072|TWO_SIDED|95.0|0.95|3.32|||Regression, Logistic|||||3.32|0.95|0.072
73823486|NCT03428100|147192919|SUPERIORITY||Odds Ratio (OR)|1.56||||0.224|TWO_SIDED|95.0|0.76|3.18|||Regression, Logistic|||||3.18|0.76|0.224
73823487|NCT03428100|147192920|SUPERIORITY||Odds Ratio (OR)|5.03||||0.265|TWO_SIDED|95.0|0.29|86.08|||Regression, Logistic|||||86.08|0.29|0.265
73823488|NCT03428100|147192920|SUPERIORITY||Odds Ratio (OR)|2.54||||0.52|TWO_SIDED|95.0|0.15|43.09|||Regression, Logistic|||||43.09|0.15|0.520
73823489|NCT03428100|147192920|SUPERIORITY||Odds Ratio (OR)|7.17||||0.164|TWO_SIDED|95.0|0.45|99.99|||Regression, Logistic|||||99.99|0.45|0.164
73823490|NCT03428100|147192921|SUPERIORITY||Mean Difference (Final Values)|-6.08|STANDARD_ERROR_OF_MEAN|2.948||0.04|TWO_SIDED|95.0|-11.88|-0.29|||Mixed Models Analysis|||||-0.29|-11.88|0.040
73823491|NCT03428100|147192921|SUPERIORITY||Mean Difference (Final Values)|-6.56|STANDARD_ERROR_OF_MEAN|2.533||0.01|TWO_SIDED|95.0|-11.54|-1.58|||Mixed Models Analysis|||||-1.58|-11.54|0.010
73823492|NCT03428100|147192921|SUPERIORITY||Mean Difference (Final Values)|-9.77|STANDARD_ERROR_OF_MEAN|2.919|<|0.001|TWO_SIDED|95.0|-15.51|-4.03|||Mixed Models Analysis|||||-4.03|-15.51|<0.001
73823493|NCT03428100|147192922|SUPERIORITY||Odds Ratio (OR)|4.75||||0.265|TWO_SIDED|95.0|0.31|73.93|||Regression, Logistic|||||73.93|0.31|0.265
73823494|NCT03428100|147192922|SUPERIORITY||Odds Ratio (OR)|2.5||||0.511|TWO_SIDED|95.0|0.16|38.4|||Regression, Logistic|||||38.40|0.16|0.511
73823495|NCT03428100|147192922|SUPERIORITY||Odds Ratio (OR)|4.95||||0.253|TWO_SIDED|95.0|0.32|77.11|||Regression, Logistic|||||77.11|0.32|0.253
73823496|NCT03428100|147192923|SUPERIORITY||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|3.078||0.044|TWO_SIDED|95.0|-12.26|-0.16|||Mixed Models Analysis|||||-0.16|-12.26|0.044
73823497|NCT03428100|147192923|SUPERIORITY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.632||0.037|TWO_SIDED|95.0|-10.67|-0.32|||Mixed Models Analysis|||||-0.32|-10.67|0.037
73823498|NCT03428100|147192923|SUPERIORITY||Mean Difference (Final Values)|-8.41|STANDARD_ERROR_OF_MEAN|3.03||0.006|TWO_SIDED|95.0|-14.37|-2.45|||Mixed Models Analysis|||||-2.45|-14.37|0.006
73823499|NCT03428100|147192924|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>.999
73823500|NCT03428100|147192924|SUPERIORITY|||||||0.797|||||||Fisher Exact|||||||0.797
73823501|NCT03428100|147192924|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>.999
73823502|NCT03428100|147192925|SUPERIORITY||Mean Difference (Final Values)|8.62|STANDARD_ERROR_OF_MEAN|4.49||0.056|TWO_SIDED|95.0|-0.22|17.45|||ANCOVA|||||17.45|-0.22|0.056
73823503|NCT03428100|147192925|SUPERIORITY||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|3.92||0.164|TWO_SIDED|95.0|-2.24|13.19|||ANCOVA|||||13.19|-2.24|0.164
73823504|NCT03428100|147192925|SUPERIORITY||Mean Difference (Final Values)|7.25|STANDARD_ERROR_OF_MEAN|4.53||0.11|TWO_SIDED|95.0|-1.66|16.15|||ANCOVA|||||16.15|-1.66|0.110
73823505|NCT03428100|147192926|SUPERIORITY||Mean Difference (Final Values)|-48.06|STANDARD_ERROR_OF_MEAN|35.63||0.178|TWO_SIDED|95.0|-118.0|21.88|||ANOVA|||||21.88|-118.00|0.178
73823506|NCT03428100|147192926|SUPERIORITY||Mean Difference (Final Values)|-56.9|STANDARD_ERROR_OF_MEAN|30.9||0.066|TWO_SIDED|95.0|-117.56|3.77|||ANOVA|||||3.77|-117.56|0.066
73823507|NCT03428100|147192926|SUPERIORITY||Mean Difference (Final Values)|-71.42|STANDARD_ERROR_OF_MEAN|35.57||0.045|TWO_SIDED|95.0|-141.24|-1.6|||ANOVA|||||-1.60|-141.24|0.045
73823508|NCT03428100|147192927|SUPERIORITY||Mean Difference (Final Values)|-11.32|STANDARD_ERROR_OF_MEAN|6.62||0.088|TWO_SIDED|95.0|-24.33|1.7|||Mixed Models Analysis|||||1.70|-24.33|0.088
73823509|NCT03428100|147192927|SUPERIORITY||Mean Difference (Final Values)|-15.41|STANDARD_ERROR_OF_MEAN|5.725||0.007|TWO_SIDED|95.0|-26.67|-4.16|||Mixed Models Analysis|||||-4.16|-26.67|0.007
73823510|NCT03428100|147192927|SUPERIORITY||Mean Difference (Final Values)|-19.76|STANDARD_ERROR_OF_MEAN|6.583||0.003|TWO_SIDED|95.0|-32.71|-6.82|||Mixed Models Analysis|||||-6.82|-32.71|0.003
73823511|NCT03428100|147192928|SUPERIORITY||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|7.263||0.055|TWO_SIDED|95.0|-28.28|0.28|||Mixed Models Analysis|||||0.28|-28.28|0.055
73823512|NCT03428100|147192928|SUPERIORITY||Mean Difference (Final Values)|-14.76|STANDARD_ERROR_OF_MEAN|6.297||0.02|TWO_SIDED|95.0|-27.15|-2.38|||Mixed Models Analysis|||||-2.38|-27.15|0.020
73823513|NCT03428100|147192928|SUPERIORITY||Mean Difference (Final Values)|-17.82|STANDARD_ERROR_OF_MEAN|7.216||0.014|TWO_SIDED|95.0|-32.01|-3.62|||Mixed Models Analysis|||||-3.62|-32.01|0.014
73823514|NCT03428100|147192929|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|1.229||0.095|TWO_SIDED|95.0|-4.47|-0.36|||Mixed Models Analysis|||||-0.36|-4.47|0.095
73823515|NCT03428100|147192929|SUPERIORITY||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|1.057||0.004|TWO_SIDED|95.0|-5.16|-1.01|||Mixed Models Analysis|||||-1.01|-5.16|0.004
73823516|NCT03428100|147192929|SUPERIORITY||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|1.216|<|0.001|TWO_SIDED|95.0|-7.48|-2.7|||Mixed Models Analysis|||||-2.70|-7.48|<0.001
73823517|NCT03428100|147192930|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.146||0.097|TWO_SIDED|95.0|-0.53|0.04|||Mixed Models Analysis|||||0.04|-0.53|0.097
73823518|NCT03428100|147192930|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.126||0.033|TWO_SIDED|95.0|-0.52|-0.02|||Mixed Models Analysis|||||-0.02|-0.52|0.033
73823519|NCT03428100|147192930|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.145|<|0.001|TWO_SIDED|95.0|-0.86|-0.29|||Mixed Models Analysis|||||-0.29|-0.86|<0.001
73823520|NCT03428100|147192931|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.516||0.272|TWO_SIDED|95.0|-1.58|0.45|||Mixed Models Analysis|||Anxiety||0.45|-1.58|0.272
73823521|NCT03428100|147192931|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.446||0.013|TWO_SIDED|95.0|-1.99|-0.24|||Mixed Models Analysis|||Anxiety||-0.24|-1.99|0.013
73823522|NCT03428100|147192931|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.511||0.099|TWO_SIDED|95.0|-1.85|0.16|||Mixed Models Analysis|||Anxiety||0.16|-1.85|0.099
73823523|NCT03428100|147192931|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.519||0.584|TWO_SIDED|95.0|-1.3|0.74|||Mixed Models Analysis|||Depression||0.74|-1.30|0.584
73823524|NCT03428100|147192931|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.448||0.162|TWO_SIDED|95.0|-1.51|0.25|||Mixed Models Analysis|||Depression||0.25|-1.51|0.162
73823525|NCT03428100|147192931|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.515||0.024|TWO_SIDED|95.0|-2.18|-0.15|||Mixed Models Analysis|||Depression||-0.15|-2.18|0.024
73823526|NCT03428100|147192932|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.018||0.228|TWO_SIDED|95.0|-3.23|0.77|||Mixed Models Analysis|||||0.77|-3.23|0.228
73823527|NCT03428100|147192932|SUPERIORITY||Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|0.876||0.065|TWO_SIDED|95.0|-3.35|0.1|||Mixed Models Analysis|||||0.10|-3.35|0.065
73823528|NCT03428100|147192932|SUPERIORITY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|1.007||0.003|TWO_SIDED|95.0|-4.99|-1.02|||Mixed Models Analysis|||||-1.02|-4.99|0.003
73823529|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|3.339||0.784|TWO_SIDED|95.0|-7.5|5.67|||Mixed Models Analysis|||Change from Baseline (CFB) Absenteeism||5.67|-7.50|0.784
73823530|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|2.813||0.525|TWO_SIDED|95.0|-3.75|7.34|||Mixed Models Analysis|||CFB Absenteeism||7.34|-3.75|0.525
73823531|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|3.204||0.947|TWO_SIDED|95.0|-6.11|6.53|||Mixed Models Analysis|||CFB Absenteeism||6.53|-6.11|0.947
73823532|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|3.06|STANDARD_ERROR_OF_MEAN|4.409||0.488|TWO_SIDED|95.0|-5.62|11.74|||Mixed Models Analysis|||CFB Presenteeism||11.74|-5.62|0.488
73823533|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.72||0.936|TWO_SIDED|95.0|-7.02|7.62|||Mixed Models Analysis|||CFB Presenteeism||7.62|-7.02|0.936
73823534|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|4.267||0.991|TWO_SIDED|95.0|-8.35|8.45|||Mixed Models Analysis|||CFB Presenteeism||8.45|-8.35|0.991
73823535|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|4.938||0.816|TWO_SIDED|95.0|-8.57|10.88|||Mixed Models Analysis|||CFB Work Productivity Loss||10.88|-8.57|0.816
73823536|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|4.178||0.971|TWO_SIDED|95.0|-8.08|8.38|||Mixed Models Analysis|||CFB Work Productivity Loss||8.38|-8.08|0.971
73823537|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|4.804||0.852|TWO_SIDED|95.0|-10.36|8.56|||Mixed Models Analysis|||CFB Work Productivity Loss||8.56|-10.36|0.852
73823538|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|3.877||0.607|TWO_SIDED|95.0|-9.61|5.63|||Mixed Models Analysis|||CFB Activity Impairment||5.63|-9.61|0.607
73823539|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|3.319||0.186|TWO_SIDED|95.0|-10.92|2.12|||Mixed Models Analysis|||CFB Activity Impairment||2.12|-10.92|0.186
73823540|NCT03428100|147192933|SUPERIORITY||Mean Difference (Final Values)|-7.45|STANDARD_ERROR_OF_MEAN|3.82||0.052|TWO_SIDED|95.0|-14.96|0.06|||Mixed Models Analysis|||CFB Activity Impairment||0.06|-14.96|0.052
73823541|NCT03428100|147192934|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.022||0.131|TWO_SIDED|95.0|-0.01|0.08|||Mixed Models Analysis|||CFB US Health State Index||0.08|-0.01|0.131
73823542|NCT03428100|147192934|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.017|TWO_SIDED|95.0|0.01|0.08|||Mixed Models Analysis|||CFB US Health State Index||0.08|0.01|0.017
73823543|NCT03428100|147192934|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.022||0.003|TWO_SIDED|95.0|0.02|0.11|||Mixed Models Analysis|||CFB US Health State Index||0.11|0.02|0.003
73823544|NCT03428100|147192934|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.031||0.102|TWO_SIDED|95.0|-0.01|0.11|||Mixed Models Analysis|||CFB UK Health State Index||0.11|-0.01|0.102
73823545|NCT03428100|147192934|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.027||0.014|TWO_SIDED|95.0|0.01|0.12|||Mixed Models Analysis|||CFB UK Health State Index||0.12|0.01|0.014
73823546|NCT03428100|147192934|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.031||0.003|TWO_SIDED|95.0|0.03|0.15|||Mixed Models Analysis|||CFB UK Health State Index||0.15|0.03|0.003
73823547|NCT03428100|147192935|SUPERIORITY||Mean Difference (Final Values)|3.99|STANDARD_ERROR_OF_MEAN|3.256||0.221|TWO_SIDED|95.0|-2.41|10.39|||Mixed Models Analysis|||||10.39|-2.41|0.221
73823548|NCT03428100|147192935|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|2.807||0.689|TWO_SIDED|95.0|-4.4|6.65|||Mixed Models Analysis|||||6.65|-4.40|0.689
73823549|NCT03428100|147192935|SUPERIORITY||Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|3.226||0.294|TWO_SIDED|95.0|-2.95|9.74|||Mixed Models Analysis|||||9.74|-2.95|0.294
73823550|NCT03428100|147192936|SUPERIORITY||Odds Ratio (OR)|1.33||||0.382|TWO_SIDED|95.0|0.7|2.54|||Regression, Logistic|||||2.54|0.70|0.382
73823551|NCT03428100|147192936|SUPERIORITY||Odds Ratio (OR)|1.15||||0.638|TWO_SIDED|95.0|0.65|2.02|||Regression, Logistic|||||2.02|0.65|0.638
73823552|NCT03428100|147192936|SUPERIORITY||Odds Ratio (OR)|1.56||||0.169|TWO_SIDED|95.0|0.83|2.96|||Regression, Logistic|||||2.96|0.83|0.169
73823553|NCT03428100|147192937|SUPERIORITY||LS Mean Difference (Final Values)|-7.36|STANDARD_ERROR_OF_MEAN|9.674||0.447|TWO_SIDED|95.0|-26.38|11.66|||Regression, Linear|||||11.66|-26.38|0.447
73823554|NCT03428100|147192937|SUPERIORITY||LS Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|8.454||0.646|TWO_SIDED|95.0|-20.5|12.74|||Regression, Linear|||||12.74|-20.50|0.646
73823555|NCT03428100|147192937|SUPERIORITY||LS Mean Difference (Final Values)|-17.18|STANDARD_ERROR_OF_MEAN|9.64||0.075|TWO_SIDED|95.0|-36.14|1.77|||Regression, Linear|||||1.77|-36.14|0.075
73823556|NCT04556760|147192955|OTHER||Mean Difference (Final Values)|-132.9528||||0.036|TWO_SIDED|95.0|-256.5082|-9.3973|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-9.3973|-256.5082|0.036
73823557|NCT04556760|147192955|OTHER||Mean Difference (Final Values)|-142.033||||0.432|TWO_SIDED|95.0|-554.8722|270.8061|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||270.8061|-554.8722|0.432
73823558|NCT04556760|147192955|OTHER||Mean Difference (Final Values)|-126.8829||||0.03|TWO_SIDED|95.0|-236.0426|-17.7233|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||-17.7233|-236.0426|0.030
73823559|NCT04556760|147192956|OTHER||Mean Difference (Final Values)|-1.5067|||<|0.001|TWO_SIDED|95.0|-2.082|-0.9314|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-0.9314|-2.0820|<0.001
73823560|NCT04556760|147192956|OTHER||Mean Difference (Final Values)|-1.1099|||<|0.001|TWO_SIDED|95.0|-1.7257|-0.4941|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||-0.4941|-1.7257|<0.001
73823561|NCT04556760|147192956|OTHER||Mean Difference (Final Values)|-0.1601||||0.547||95.0|-0.693|0.3729|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.3729|-0.6930|0.547
73823562|NCT04556760|147192957|OTHER||Mean Difference (Final Values)|-1.5015|||<|0.001|TWO_SIDED|95.0|-2.2258|-0.7773|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[00 to 24 h\])||-0.7773|-2.2258|<0.001
73823563|NCT04556760|147192957|OTHER||Mean Difference (Final Values)|-1.8643|||<|0.001||95.0|-2.5611|-1.1674|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[24 to 48 h\])||-1.1674|-2.5611|<0.001
73823564|NCT04556760|147192957|OTHER||Mean Difference (Final Values)|-1.5998|||<|0.001|TWO_SIDED|95.0|-2.3025|-0.8971|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[48 to 72 h\])||-0.8971|-2.3025|<0.001
73823565|NCT04556760|147192957|OTHER||Mean Difference (Final Values)|-0.8474||||0.013|TWO_SIDED|95.0|-1.4465|-0.2484|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[00 to 24 h\])||-0.2484|-1.4465|0.013
73823566|NCT04556760|147192957|OTHER||Mean Difference (Final Values)|-0.7778||||0.061|TWO_SIDED|95.0|-1.6022|0.0466|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[24 to 48 h\])||0.0466|-1.6022|0.061
73823567|NCT04556760|147192957|OTHER||Mean Difference (Final Values)|-1.143||||0.003|TWO_SIDED|95.0|-1.7622|-0.5238|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[48 to 72 h\])||-0.5238|-1.7622|0.003
73823568|NCT04556760|147192957|OTHER||Mean Difference (Final Values)|-0.36||||0.125|TWO_SIDED|95.0|-0.8338|0.1138|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[00 to 24 h\])||0.1138|-0.8338|0.125
73823569|NCT04556760|147192957|OTHER||Mean Difference (Final Values)|-0.0845||||0.84|TWO_SIDED|95.0|-0.9706|0.8016|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[24 to 48 h\])||0.8016|-0.9706|0.840
73823570|NCT04556760|147192957|OTHER||Mean Difference (Final Values)|-0.1298||||0.571|TWO_SIDED|95.0|-0.646|0.3864|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[48 to 72 h\])||0.3864|-0.6460|0.571
73823571|NCT04556760|147192958|OTHER||Mean Difference (Final Values)|-0.07||||0.753|TWO_SIDED|95.0|-0.55|0.4|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.40|-0.55|0.753
73823572|NCT04556760|147192958|OTHER||Mean Difference (Final Values)|-0.04||||0.802|TWO_SIDED|95.0|-0.46|0.37|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.37|-0.46|0.802
73823573|NCT04556760|147192958|OTHER||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-0.37|0.37|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.37|-0.37|0.985
73823574|NCT04556760|147192959|OTHER||Mean Difference (Final Values)|20498.7|||<|0.001|TWO_SIDED|95.0|10819.2|30178.2|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||30178.2|10819.2|<0.001
73823575|NCT04556760|147192959|OTHER||Mean Difference (Final Values)|3321.4||||0.659|TWO_SIDED|95.0|-12975.8|19618.6|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||19618.6|-12975.8|0.659
73823576|NCT04556760|147192959|OTHER||Mean Difference (Final Values)|-2698.8||||0.521|TWO_SIDED|95.0|-14849.0|9451.3|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||9451.3|-14849.0|0.521
73823577|NCT04556760|147192960|OTHER||Mean Difference (Final Values)|-1002.5864||||0.003|TWO_SIDED|95.0|-1620.215|-384.9577|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-384.9577|-1620.2150|0.003
73823578|NCT04556760|147192960|OTHER||Mean Difference (Final Values)|40.9836||||0.865|TWO_SIDED|95.0|-526.6968|608.664|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||608.6640|-526.6968|0.865
73823579|NCT04556760|147192960|OTHER||Mean Difference (Final Values)|101.4137||||0.754|TWO_SIDED|95.0|-628.8097|831.637|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||831.6370|-628.8097|0.754
73823580|NCT04556760|147192961|OTHER||Mean Difference (Final Values)|-1225.905||||0.004|TWO_SIDED|95.0|-2007.2241|-444.5859|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-444.5859|-2007.2241|0.004
73823581|NCT04556760|147192961|OTHER||Mean Difference (Final Values)|-466.9802||||0.313|TWO_SIDED|95.0|-1521.5088|587.5485|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||587.5485|-1521.5088|0.313
73823582|NCT04556760|147192961|OTHER||Mean Difference (Final Values)|-375.3161||||0.404||95.0|-1433.6265|682.9943|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||682.9943|-1433.6265|0.404
73823583|NCT04556760|147192962|OTHER||Mean Difference (Final Values)|365.6323||||0.608|TWO_SIDED|95.0|-1097.7973|1829.0618|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||1829.0618|-1097.7973|0.608
73823584|NCT04556760|147192962|OTHER||Mean Difference (Final Values)|188.236||||0.897|TWO_SIDED|95.0|-3214.3323|3590.8043|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||3590.8043|-3214.3323|0.897
73823585|NCT04556760|147192962|OTHER||Mean Difference (Final Values)|-1061.4494||||0.381||95.0|-3588.2233|1465.3244|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||1465.3244|-3588.2233|0.381
73823586|NCT04556760|147192963|OTHER||Mean Difference (Final Values)|60.4211|||<|0.001||95.0|29.4904|91.3518|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||91.3518|29.4904|<0.001
73823587|NCT04556760|147192963|OTHER||Mean Difference (Final Values)|26.4529||||0.432||95.0|-44.9414|97.8471|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||97.8471|-44.9414|0.432
73823588|NCT04556760|147192963|OTHER||Mean Difference (Final Values)|-24.0243||||0.282||95.0|-74.0731|26.0245|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||26.0245|-74.0731|0.282
73823589|NCT04556760|147192964|OTHER||Mean Difference (Final Values)|-0.6023||||0.531|TWO_SIDED|95.0|-2.5463|1.3416|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||1.3416|-2.5463|0.531
73823590|NCT04556760|147192964|OTHER||Mean Difference (Final Values)|0.4621||||0.682|TWO_SIDED|95.0|-2.0933|3.0176|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||3.0176|-2.0933|0.682
73823591|NCT04556760|147192965|OTHER||Mean Difference (Final Values)|0.0679||||0.526||95.0|-0.152|0.2866|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.2866|-0.1520|0.526
73823592|NCT04556760|147192965|OTHER||Mean Difference (Final Values)|0.0882||||0.569||95.0|-0.2653|0.4416|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg||0.4416|-0.2653|0.569
73823593|NCT04556760|147192965|OTHER||Mean Difference (Final Values)|0.1257||||0.166|TWO_SIDED|95.0|-0.0677|0.3191|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.3191|-0.0677|0.166
73823594|NCT04556760|147192966|OTHER||Mean Difference (Final Values)|0.01||||0.226|TWO_SIDED|95.0|-0.0072|0.0271|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.0271|-0.0072|0.226
73823595|NCT04556760|147192966|OTHER||Mean Difference (Final Values)|0.0033||||0.619||95.0|-0.0128|0.0195|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.0195|-0.0128|0.619
73823596|NCT04556760|147192966|OTHER||Mean Difference (Final Values)|0.0009||||0.917||95.0|-0.0189|0.0207|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.0207|-0.0189|0.917
73823597|NCT04556760|147192967|OTHER||Mean Difference (Final Values)|0.0007||||0.357|TWO_SIDED|95.0|-0.0008|0.0022|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.0022|-0.0008|0.357
73823598|NCT04556760|147192967|OTHER||Mean Difference (Final Values)|0.0003||||0.676|TWO_SIDED|95.0|-0.0012|0.0017|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.0017|-0.0012|0.676
73823599|NCT04556760|147192967|OTHER||Mean Difference (Final Values)|0.0012||||0.096||95.0|-0.0002|0.0026|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.0026|-0.0002|0.096
73823600|NCT04556760|147192968|OTHER||Mean Difference (Final Values)|-1.73||||0.646|TWO_SIDED|95.0|-9.4|5.95|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||5.95|-9.40|0.646
73823601|NCT04556760|147192968|OTHER||Mean Difference (Final Values)|-10.97||||0.11||95.0|-25.39|3.44|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||3.44|-25.39|0.110
73823602|NCT04556760|147192968|OTHER||Mean Difference (Final Values)|-0.35||||0.932||95.0|-10.32|9.61|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||9.61|-10.32|0.932
73823603|NCT04556760|147192969|OTHER||Mean Difference (Final Values)|7.6||||0.533|TWO_SIDED|95.0|-17.4|32.7|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||32.7|-17.4|0.533
73823604|NCT04556760|147192969|OTHER||Mean Difference (Final Values)|22.3||||0.311||95.0|-26.7|71.3|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||71.3|-26.7|0.311
73823605|NCT04556760|147192969|OTHER||Mean Difference (Final Values)|31.0||||0.204||95.0|-21.9|83.9|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||83.9|-21.9|0.204
73823606|NCT04556760|147192979|OTHER||Mean Difference (Final Values)|-4.0066||||0.103|TWO_SIDED|95.0|-8.888|0.8748|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.8748|-8.8880|0.103
73823607|NCT04556760|147192979|OTHER||Mean Difference (Final Values)|5.7535||||0.005||95.0|2.6034|8.9036|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||8.9036|2.6034|0.005
73823608|NCT04556760|147192979|OTHER||Mean Difference (Final Values)|9.0619||||0.023||95.0|1.674|16.4499|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||16.4499|1.6740|0.023
73823609|NCT02168491|147192984|SUPERIORITY_OR_OTHER||||||<|0.02|||||||paired t test|||||||<0.02
73823610|NCT02168491|147192985|SUPERIORITY_OR_OTHER|||||||0.24|||||||paired t test|||||||0.24
73823611|NCT02168491|147192986|SUPERIORITY_OR_OTHER|||||||0.28|||||||paired t test|||||||0.28
73823612|NCT00705757|147193003|SUPERIORITY_OR_OTHER|||||||0.769|TWO_SIDED||||||ANOVA|||One way ANOVA of Upper Lid||||0.769
73823613|NCT00705757|147193003|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0|||||ANOVA|||One way ANOVA of Lower Lid||||0.230
73823614|NCT00705757|147193003|SUPERIORITY_OR_OTHER|||||||0.851|TWO_SIDED|95.0|||||ANOVA|||One way ANOVA of cheek/face||||0.851
73823615|NCT01411852|147193005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39|||||TWO_SIDED|95.0|0.12|1.25|||||Adjusted for age (linear spline with knot at 45 years), penetrating vs. blunt or no trauma (1 patient had neither blunt nor penetrating trauma), and Injury Severity Score (ISS). ISS multiply imputed for one patient.|||1.25|0.12|
73823616|NCT01411852|147193006|SUPERIORITY_OR_OTHER||percent difference|-16.0|||||TWO_SIDED|95.0|-26.5|-5.5||||||||-5.5|-26.5|
73823617|NCT01411852|147193007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-2.76|0.4||||||||0.40|-2.76|
73823618|NCT01411852|147193008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-1.61|0.08||||||||0.08|-1.61|
73823619|NCT01411852|147193009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-1.8|2.2||||||||2.2|-1.8|
73823620|NCT01411852|147193010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.3|1.0||||||||1.0|-0.3|
73823621|NCT01411852|147193011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|||||TWO_SIDED|95.0|-42.5|1.6||||||||1.6|-42.5|
73823622|NCT01411852|147193012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.06|0.1||||||||0.10|-0.06|
73823623|NCT01411852|147193013|SUPERIORITY_OR_OTHER||percent difference|-10.2|||||TWO_SIDED|95.0|-22.4|2.0||||||||2.0|-22.4|
73823624|NCT01411852|147193014|SUPERIORITY_OR_OTHER||percent difference|-18.9|||||TWO_SIDED|95.0|-39.2|1.4||||||||1.4|-39.2|
73823625|NCT01411852|147193015|SUPERIORITY_OR_OTHER||percent difference|-10.4|||||TWO_SIDED|95.0|-29.6|8.8||||||||8.8|-29.6|
73823626|NCT01411852|147193016|SUPERIORITY_OR_OTHER||percent difference|-4.4|||||TWO_SIDED|95.0|-16.6|7.8||||||||7.8|-16.6|
73823627|NCT01411852|147193017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.8|2.1||||||||2.1|-3.8|
73823628|NCT01411852|147193018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.6|2.4||||||||2.4|-3.6|
73823629|NCT01411852|147193019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-2.9|3.1||||||||3.1|-2.9|
73823630|NCT01411852|147193020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17|||||TWO_SIDED|95.0|0.03|0.92|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS). ISS multiply imputed for one patient.|||0.92|0.03|
73823631|NCT01411852|147193021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|0.19|19.11|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS).|||19.11|0.19|
73823632|NCT01411852|147193022|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.22|1.77|||||Adjusted for age (linear spline with knot at 45 years), penetrating mechanism (yes/no), and ISS (linear).|||1.77|0.22|
73823633|NCT03126786|147193047|SUPERIORITY|The sample size was determined such that the difference in visual acuity between the ACTIVE treatment group and CONTROL treatment group could be estimated within +/- five ETDRS letters. Week 24 data from the Eylea prescribing information was used to estimate a pooled standard deviation of 9.17 letters. With 28 subjects per arm, a two-sided 90% confidence interval with a distance from the mean difference to the limits (half of interval width) will be less than 5 letters.|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.28||0.288|TWO_SIDED|90.0|-6.2|1.4||There was a single primary outcome tested at a single primary endpoint, therefore no adjustments for multiple comparisons were performed. The primary endpoint was assess with a 2-sided alpha level of 0.100.|Mixed model for repeat measures|The covariance structure was assumed to be unstructured.|Estimated Value calculated as Active minus Control.|The primary efficacy analysis comparing ACTIVE with CONTROL on the mean change from baseline (Visit 2, Day 0) BCVA at Week 12 was be performed using a Mixed Model for Repeated Measurements (MMRM). This model included treatment (ACTIVE or CONTROL), visit (Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20) and Visit 8 (Week 24), and the 2-way interactions of treatment and visit, and the BCVA baseline included as the covariate.||1.4|-6.2|0.288
73823634|NCT03804268|147193071|SUPERIORITY||Percentage Difference|22.5|||<|0.0001|TWO_SIDED|95.0|14.3|30.8||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||30.8|14.3|<0.0001
73823635|NCT03804268|147193072|SUPERIORITY||Percentage Difference|9.7||||0.0114|TWO_SIDED|95.0|2.3|17.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||17.0|2.3|0.0114
73823636|NCT03804268|147193073|SUPERIORITY||Percentage Difference|2.1||||1|TWO_SIDED|95.0|-4.4|8.5||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||8.5|-4.4|1.0000
73823637|NCT03804268|147193074|SUPERIORITY||Least Square (LS) Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|0.72||0.0114|TWO_SIDED|95.0|3.7|6.5||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||6.5|3.7|0.0114
73823638|NCT03804268|147193075|SUPERIORITY||Percentage Difference|18.7||||0.0114|TWO_SIDED|95.0|10.6|26.7||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval was calculated based on normal approximation based on pooled variance without continuity correction.|||26.7|10.6|0.0114
73823639|NCT03804268|147193076|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.14||0.0114|TWO_SIDED|95.0|0.6|1.1||Analysis of covariance (ANCOVA) was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.1|0.6|0.0114
73823640|NCT03804268|147193077|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.55||0.0114|TWO_SIDED|95.0|2.4|4.6||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||4.6|2.4|0.0114
73823641|NCT03804268|147193078|SUPERIORITY||Percentage Difference|-1.1||||1|TWO_SIDED|95.0|-7.1|5.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||5.0|-7.1|1.0000
73823642|NCT03804268|147193079|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.66||0.0114|TWO_SIDED|95.0|1.3|3.9||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||3.9|1.3|0.0114
73823643|NCT03804268|147193080|SUPERIORITY||Percentage Difference|12.6||||0.0171|TWO_SIDED|95.0|3.5|21.6||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||21.6|3.5|0.0171
73823644|NCT03804268|147193081|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.13||0.0114|TWO_SIDED|95.0|0.5|1.1||ANCOVA was used with study intervention group, age group, baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.1|0.5|0.0114
73823645|NCT03804268|147193082|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09||0.0114|TWO_SIDED|95.0|-0.6|-0.3||ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.3|-0.6|0.0114
73823646|NCT03804268|147193083|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.08||0.0114|TWO_SIDED|95.0|-0.4|-0.1||ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.1|-0.4|0.0114
73823647|NCT01156805|147193096|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|Mixed-effects linear regression, adjusted for clustering within schools and children to assess the effect of intervention on changes in BMI over time||||||0.05
73823648|NCT01843803|147193100|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|1.5||0.029|TWO_SIDED|||||"P-Value = 0.029 after adjusting for clinical and demographic, and accounting for clustering of patients within providers.~Comparison of adjusted CARES score yielded a significant difference."|Mixed Models Analysis|A mixed model was ran with CARES as the dependent variable, adjusted for demographic and clinical measures , and provider as a random effect.||Mixed model adjusted for gender, race, education, marital status, mental health condition, substance disorder, COPD, heart failure, diabetes, coronary artery disease, study site and accounting for clustering of patients within providers.||||0.029
73823649|NCT01843803|147193102|SUPERIORITY||Odds Ratio (OR)|1.69||||0.065|TWO_SIDED|95.0|0.99|2.86||P-Value derived after adjusting model provider clustering and treating it as a random effect.|Mixed Models Analysis|||Assessed whether a person in the intervention group vs the attention control group was more likely to be probed at least once by their provider after adjusting for other measures and accounting for the provider clustering.||2.86|0.99|.065
73823650|NCT01843803|147193103|SUPERIORITY||||||<|0.05|||||||Chi-squared|||chi-square||||<0.05
73823651|NCT03138577|147193104|OTHER||||||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||
73823652|NCT03138577|147193105|OTHER|||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||
73823653|NCT03138577|147193106|OTHER||Median Difference (Final Values)|7.5||||0.01|TWO_SIDED||||||Sign test|||||||0.01
73823654|NCT03138577|147193106|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED||||||Sign test|||||||1.00
73823655|NCT03138577|147193107|OTHER||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.|||
73823656|NCT03138577|147193108|OTHER||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.|||
73823657|NCT03138577|147193109|OTHER||Median Difference (Final Values)|-1.0||||0.01|TWO_SIDED||||||Sign test|||||||0.01
73823658|NCT03138577|147193109|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED||||||Sign test|||||||1.00
73823659|NCT03138577|147193110|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
73823660|NCT02686164|147193137|OTHER||Geometric Mean Ratio|0.914|||||TWO_SIDED|90.0|0.85|0.983||||||AUC(0-24) of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam Versus (vs.) Cycle 1 Day -3, Midazolam||0.983|0.850|
73823661|NCT02686164|147193137|OTHER||Geometric Mean Ratio|1.148|||||TWO_SIDED|90.0|0.938|1.404||||||AUC(0-24) of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.404|0.938|
73823662|NCT02686164|147193137|OTHER||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|0.94|1.335||||||AUC(0-24) of 1'-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.335|0.940|
73823663|NCT02686164|147193137|OTHER||Geometric Mean Ratio|1.199|||||TWO_SIDED|90.0|1.057|1.36||||||AUC(0-24) of 1'-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady-state) + Midazolam vs.Cycle 1 Day -3, Midazolam||1.360|1.057|
73823664|NCT02686164|147193138|OTHER||Geometric Mean Ratio|0.862|||||TWO_SIDED|90.0|0.753|0.988||||||Cmax of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||0.988|0.753|
73823665|NCT02686164|147193138|OTHER||Geometric Mean Ratio|1.027|||||TWO_SIDED|90.0|0.852|1.238||||||Cmax of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.238|0.852|
73823666|NCT02686164|147193138|OTHER||Geometric Mean Ratio|1.055|||||TWO_SIDED|90.0|0.879|1.268||||||Cmax of 1'-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.268|0.879|
73823667|NCT02686164|147193138|OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.845|1.046||||||Cmax of 1'-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.046|0.845|
73823668|NCT00672633|147193153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.52||95.0|||||ANOVA|Repeated measures||The study was designed with 80% power to detect a net improvement of Triglyceride elevles with a sample size of 60.||||0.52
73823669|NCT00672633|147193154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.06||95.0|||||ANOVA|Repeated Measures||No power calculations done for this outcomes||||0.06
73823670|NCT00672633|147193155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3||||0.27||95.0|||||ANOVA|Repeated Measures||No power calculations were conducted for this outcome||||0.27
73823671|NCT02465164|147193171|OTHER|Wilcoxon rank-sum tests||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
73823672|NCT01481558|147193176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.01||0.55|TWO_SIDED|95.0|||||ANCOVA|||||||0.55
73823673|NCT02359110|147193177|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.89|TWO_SIDED|95.0|-1.2|1.3|||Mixed Models Analysis|||Hour 2 Analysis||1.3|-1.2|0.89
73823674|NCT02359110|147193177|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.94|TWO_SIDED|95.0|-1.6|1.5|||Mixed Models Analysis|||Hour 4 Analysis||1.5|-1.6|0.94
73823675|NCT02359110|147193177|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.64|TWO_SIDED|95.0|-2.2|1.3|||Mixed Models Analysis|||Hour 6 Analysis||1.3|-2.2|0.64
73823676|NCT02359110|147193177|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.59|TWO_SIDED|95.0|-1.6|2.8|||Mixed Models Analysis|||Hour 8 Analysis||2.8|-1.6|0.59
73823677|NCT02359110|147193178|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.52|TWO_SIDED|95.0|-8.1|15.8|||Mixed Models Analysis|||Hour 2 Analysis||15.8|-8.1|0.52
73823678|NCT02359110|147193178|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.8|TWO_SIDED|95.0|-11.9|15.3|||Mixed Models Analysis|||Hour 6 Analysis||15.3|-11.9|0.80
73823679|NCT02359110|147193179|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
73823680|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5221||||||The reported p-value is representative of the changes in levels of all CD4 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5221
73823681|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.25||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 1.|Wilcoxon test|||||||0.25
73823682|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 3.|Wilcoxon test|||||||0.50
73823683|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.16||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 4.|Wilcoxon test|||||||0.16
73823684|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8665||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.8665
73823685|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.88
73823686|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.84||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 3.|Wilcoxon test|||||||0.84
73823687|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.57||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 4.|Wilcoxon test|||||||0.57
73823688|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3052||||||The reported p-value is representative of the changes in levels of all B cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3052
73823689|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of B cells at dose level 1.|Wilcoxon test|The reported p-value is representative of the changes in levels of B cells at dose level 1.||||||>0.9999
73823690|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of B cells at dose level 3.|Wilcoxon test|||||||0.13
73823691|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.65||||||The reported p-value is representative of the changes in levels of B cells at dose level 4.|Wilcoxon test|||||||0.65
73823692|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0698||||||The reported p-value is representative of the changes in levels of all NK cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0698
73823693|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of NK cells at dose level 1.|Wilcoxon test|||||||0.63
73823694|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.74||||||The reported p-value is representative of the changes in levels of NK cells at dose level 3.|Wilcoxon test|||||||0.74
73823695|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of NK cells at dose level 4.|Wilcoxon test|||||||0.13
73823696|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0127||||||The reported p-value is representative of the changes in levels of all NKT cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0127
73823697|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 1.|Wilcoxon test|||||||0.63
73823698|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.41||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 3.|Wilcoxon test|||||||0.41
73823699|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.07||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 4.|Wilcoxon test|||||||0.07
73823700|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0654||||||The reported p-value is representative of the changes in levels of all cDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0654
73823701|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 1.|Wilcoxon test|||||||0.38
73823702|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.21||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 3.|Wilcoxon test|||||||0.21
73823703|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.16||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 4.|Wilcoxon test|||||||0.16
73823704|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0457||||||The reported p-value is representative of the changes in levels of all pDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0457
73823705|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 1.|Wilcoxon test|||||||0.63
73823706|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.55||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 3.|Wilcoxon test|||||||0.55
73823707|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 4.|Wilcoxon test|||||||0.13
73823708|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7114||||||The reported p-value is representative of the changes in levels of all MDSC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.7114
73823709|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 1.|Wilcoxon test|||||||>0.9999
73823710|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 3.|Wilcoxon test|||||||0.38
73823711|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.91||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 4.|Wilcoxon test|||||||0.91
73823712|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2666||||||The reported p-value is representative of the changes in levels of all Treg cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.2666
73823713|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test|||||||0.88
73823714|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.45||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test|||||||0.45
73823715|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.36||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 4.|Wilcoxon test|||||||0.36
73823716|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0076||||||The reported p-value is representative of the changes in levels of all CD4 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0076
73823717|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 1.|Wilcoxon test|||||||0.38
73823718|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.22||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 3.|Wilcoxon test|||||||0.22
73823719|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.1||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 4.|Wilcoxon test|||||||0.10
73823720|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7144||||||The reported p-value is representative of the changes in levels of all CD4 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.7144
73823721|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 1.|Wilcoxon test|||||||0.13
73823722|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.06||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 3.|Wilcoxon test|||||||0.06
73823723|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 4.|Wilcoxon test|||||||0.13
73823724|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3741||||||The reported p-value is representative of the changes in levels of all CD4 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3741
73823725|NCT01519817|147193186|NON_INFERIORITY|The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 1.||||||0.63|||||||Wilcoxon test|||||||0.63
73823726|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 3.|Wilcoxon test|||||||0.13
73823727|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 4.|Wilcoxon test|||||||>0.9999
73823728|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3386||||||The reported p-value is representative of the changes in levels of all CD4 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3386
73823729|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 1.|Wilcoxon test|||||||0.88
73823730|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0215||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 3.|Wilcoxon test|||||||0.0215
73823731|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.65||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 4.|Wilcoxon test|||||||0.65
73823732|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5076||||||The reported p-value is representative of the changes in levels of all CD8 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5076
73823733|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 1.|Wilcoxon test|||||||0.63
73823734|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.68||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 3.|Wilcoxon test|||||||0.68
73823735|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.73||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 4.|Wilcoxon test|||||||0.73
73823736|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6577||||||The reported p-value is representative of the changes in levels of all CD8 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6577
73823737|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 1.|Wilcoxon test|||||||0.88
73823738|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.74||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 3.|Wilcoxon test|||||||0.74
73823739|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 4.|Wilcoxon test|||||||0.20
73823740|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6295||||||The reported p-value is representative of the changes in levels of all CD8 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6295
73823741|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 1.|Wilcoxon test|||||||0.63
73823742|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.999||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 3.|Wilcoxon test|||||||>0.999
73823743|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.36||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 4.|Wilcoxon test|||||||0.36
73823744|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8314||||||The reported p-value is representative of the changes in levels of all CD8 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.8314
73823745|NCT01519817|147193186|NON_INFERIORITY|The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 1.||||||0.63|||||||Wilcoxon test|||||||0.63
73823746|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.64||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 3.|Wilcoxon test|||||||0.64
73823747|NCT01519817|147193186|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 4.|Wilcoxon test|||||||0.30
73823748|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.375||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 1.|Wilcoxon test|||||||0.375
73823749|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4808||||||The reported p-value is representative of the changes in levels of all IFNg cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4808
73823750|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7334||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 3.|Wilcoxon test|||||||0.7334
73823751|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7109||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 4.|Wilcoxon|||||||0.7109
73823752|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4347||||||The reported p-value is representative of the changes in levels of all IL10 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4347
73823753|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 1.|Wilcoxon|||||||>0.9999
73823754|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.748||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 3.|Wilcoxon test|||||||0.748
73823755|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8203|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 4.||||||0.8203
73823756|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5625||||||The reported p-value is representative of the changes in levels of all IL12p70 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5625
73823757|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
73823758|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 3.|Wilcoxon test|||||||>0.9999
73823759|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 14|Wilcoxon test|||||||0.5
73823760|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6846||||||The reported p-value is representative of the changes in levels of all IL1b cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6846
73823761|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
73823762|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 3.|Wilcoxon test|||||||0.5
73823763|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 4.|Wilcoxon test|||||||>0.9999
73823764|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4375||||||The reported p-value is representative of the changes in levels of all IL-2 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4375
73823765|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
73823766|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 3.|Wilcoxon test|||||||>0.9999
73823767|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.75||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 4.|Wilcoxon test|||||||0.75
73823768|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4525||||||The reported p-value is representative of the changes in levels of all IL-6 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.||||||0.4525
73823769|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.|Wilcoxon test|||||||0.875
73823770|NCT01519817|147193187|NON_INFERIORITY|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 3.||||||0.4316|||||||Wilcoxon test|||Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||0.4316
73823771|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 4.|Wilcoxon test|||||||>0.9999
73823772|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.9906||||||The reported p-value is representative of the changes in levels of all IL-8 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.9906
73823773|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.625|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 1.||||||0.625
73823774|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.791||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 3.|Wilcoxon test|||||||0.791
73823775|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8203||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 4.|Wilcoxon test|||||||0.8203
73823776|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of all TNF cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||>0.9999
73823777|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 1.|Wilcoxon test|||||||0.875
73823778|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.9658||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 3.|Wilcoxon test|||||||0.9658
73823779|NCT01519817|147193187|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6523||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 4.|Wilcoxon test|||||||0.6523
73823780|NCT01519817|147193188|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2901||||||The reported p-value is representative of the changes in levels of all sCD27 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.2901
73823781|NCT01519817|147193188|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.375||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 1.|Wilcoxon test|||||||0.375
73823782|NCT01519817|147193188|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2036||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 3.|Wilcoxon test|||||||0.2036
73823783|NCT01519817|147193188|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0742||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 4.|Wilcoxon test|||||||0.0742
73823784|NCT01519817|147193189|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.1004||||||The reported p-value is representative of the changes in levels of all ratio sCD27:sCD40AL cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.1004
73823785|NCT01519817|147193189|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.625||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 1.|Wilcoxon test|||||||0.625
73823786|NCT01519817|147193189|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6772||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 3.|Wilcoxon test|||||||0.6772
73823787|NCT01519817|147193189|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 4.|Wilcoxon test|||||||0.3008
73823788|NCT01519817|147193190|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0621||||||The reported p-value is representative of the changes in levels of all sCD40L cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0621
73823789|NCT01519817|147193190|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 1.|Wilcoxon test|||||||0.875
73823790|NCT01519817|147193190|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2402||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 3.|Wilcoxon test|||||||0.2402
73823791|NCT01519817|147193190|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 4.|Wilcoxon test|||||||0.3008
73823792|NCT02922153|147193191|SUPERIORITY|||||||0.0223|TWO_SIDED|95.0|||||t-test, 1 sided|One-sided, two-sample t-test.||||||0.0223
73823793|NCT02922153|147193192|SUPERIORITY|||||||0.6259|TWO_SIDED|95.0|||||t-test, 1 sided|One-sided two-sample t-test.||||||0.6259
73823794|NCT02922153|147193192|SUPERIORITY|||||||0.518|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon two-sample test.||||||0.518
73823795|NCT02922153|147193193|SUPERIORITY|||||||0.0201||||||FEV1 one-sided, two-sample t-test|t-test, 1 sided|||||||0.0201
73823796|NCT02922153|147193193|SUPERIORITY|||||||0.06||||||FVC one-sided, two-sample t-test|t-test, 1 sided|||||||0.06
73823797|NCT02922153|147193193|SUPERIORITY|||||||0.09||||||SVC one-sided, two-sample t-test|t-test, 1 sided|||||||0.09
73823798|NCT02922153|147193194|SUPERIORITY|||||||0.3085||||||72 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.3085
73823799|NCT02922153|147193194|SUPERIORITY|||||||0.8196||||||96 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.8196
73823800|NCT02922153|147193194|SUPERIORITY|||||||0.7269||||||120 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.7269
73823801|NCT02922153|147193196|SUPERIORITY|||||||0.4421|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||Analysis is the time from end of procedure to oral endotracheal extubation||||0.4421
73823802|NCT02922153|147193197|SUPERIORITY|||||||0.4352||||||Total Post-Procedure for Hospital Stay|Wilcoxon (Mann-Whitney)|Wilcoxon Rank-Sum Test||||||0.4352
73823803|NCT02922153|147193198|SUPERIORITY|||||||0.2939||||||ICU Length of Stay|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.2939
73823804|NCT02922153|147193198|SUPERIORITY|||||||0.0998||||||Hospital Length of Stay|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.0998
73823805|NCT02922153|147193199|SUPERIORITY|||||||0.2877|||||||Chi-squared|||48 Hours Post-Op: Patient able to sit up in bed||||0.2877
73823806|NCT02922153|147193199|SUPERIORITY|||||||0.5311|||||||Fisher Exact|||48 Hours Post-Op: Patient able to stand up||||0.5311
73823807|NCT02922153|147193199|SUPERIORITY|||||||0.4908|||||||Fisher Exact|||48 Hours Post-Op: Patient able to walk||||0.4908
73823808|NCT02922153|147193199|SUPERIORITY|||||||0.8621|||||||Fisher Exact|||48 Hours Post-Op: Right Shoulder Flexion Movement||||0.8621
73823809|NCT02922153|147193199|SUPERIORITY|||||||1|||||||Fisher Exact|||48 Hours Post-Op: Left Shoulder Flexion Movement||||1
73823810|NCT02922153|147193199|SUPERIORITY|||||||0.0133|||||||Fisher Exact|||72 Hours Post-Op: Patient able to sit up in bed||||0.0133
73823811|NCT02922153|147193199|SUPERIORITY|||||||0.0037|||||||Fisher Exact|||72 Hours Post-Op: Patient able to stand up||||0.0037
73823812|NCT02922153|147193199|SUPERIORITY|||||||0.1671|||||||Fisher Exact|||72 Hours Post-Op: Patient able to walk||||0.1671
73823813|NCT02922153|147193199|SUPERIORITY|||||||1|||||||Fisher Exact|||72 Hours Post-Op: Right Shoulder Flexion Movement||||1.000
73823814|NCT02922153|147193199|SUPERIORITY|||||||1|||||||Fisher Exact|||72 Hours Post-Op: Left Shoulder Flexion Movement||||1
73823815|NCT02922153|147193199|SUPERIORITY|||||||1|||||||Fisher Exact|||96 Hours Post-Op: Patient able to sit up in bed||||1
73823816|NCT02922153|147193199|SUPERIORITY|||||||0.2757|||||||Fisher Exact|||96 Hours Post-Op: Patient able to stand up||||0.2757
73823817|NCT02922153|147193199|SUPERIORITY|||||||0.9025|||||||Fisher Exact|||96 Hours Post-Op: Patient able to walk||||0.9025
73823818|NCT02922153|147193199|SUPERIORITY|||||||0.7942|||||||Fisher Exact|||96 Hours Post-Op: Right Shoulder Flexion Movement||||0.7942
73823819|NCT02922153|147193199|SUPERIORITY|||||||1|||||||Fisher Exact|||96 Hours Post-Op: Left Shoulder Flexion Movement||||1
73823820|NCT02922153|147193199|SUPERIORITY|||||||0.3492|||||||Fisher Exact|||120 Hours Post-Op: Patient able to sit up in bed||||0.3492
73823821|NCT02922153|147193199|SUPERIORITY|||||||0.2644|||||||Fisher Exact|||120 Hours Post-Op: Patient able to stand up||||0.2644
73823822|NCT02922153|147193199|SUPERIORITY|||||||0.8258|||||||Fisher Exact|||120 Hours Post-Op: Patient able to walk||||0.8258
73823823|NCT02922153|147193199|SUPERIORITY|||||||0.67|||||||Fisher Exact|||120 Hours Post-Op: Right Shoulder Flexion Movement||||0.67
73823824|NCT02922153|147193199|SUPERIORITY|||||||0.5693|||||||Fisher Exact|||120 Hours Post-Op: Left Shoulder Flexion Movement||||0.5693
73823825|NCT02922153|147193199|SUPERIORITY|||||||0.1189|||||||Chi-squared|||Discharge: Patient able to sit up in bed||||0.1189
73823826|NCT02922153|147193199|SUPERIORITY|||||||1|||||||Fisher Exact|||Discharge: Patient able to stand up||||1
73823827|NCT02922153|147193199|SUPERIORITY|||||||0.6992|||||||Fisher Exact|||Discharge: Patient able to walk||||0.6992
73823828|NCT02922153|147193199|SUPERIORITY|||||||0.4429|||||||Fisher Exact|||Discharge: Right Shoulder Flexion Movement||||0.4429
73823829|NCT02922153|147193199|SUPERIORITY|||||||0.4563|||||||Fisher Exact|||Discharge: Left Shoulder Flexion Movement||||0.4563
73823830|NCT03429348|147193200|SUPERIORITY||Mean Difference (Final Values)|1.18||||9e-07|TWO_SIDED||||||t-test, 2 sided|We are comparing the log transformed values.||||||0.0000009
73823831|NCT03429348|147193200|SUPERIORITY||Mean Difference (Final Values)|1.35||||1.8e-05|TWO_SIDED||||||t-test, 2 sided|We are comparing the log transformed values||||||0.000018
73823832|NCT02692586|147193202|SUPERIORITY|To detect an RV/LV ratio change \> 0.12 with a power of 80% at one-sided alpha = 0.025, the necessary sample size was calculated to be ≥ 52, 31, or 21 patients (to detect RV/LV ratio changes of 0.20, 0.225, or 0.25, respectively).|||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
73823833|NCT02692586|147193203|SUPERIORITY|The hypothesized composite MAE rate was expected to be about 13%. The necessary sample size to detect a difference from an expected MAE rate of 13% with 80% power was calculated to be 103 patients (with a one-sided p value = 0.05).|||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
73823834|NCT01064414|147193269|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.117||0.012|TWO_SIDED|95.0|-0.529|-0.066|||ANCOVA|||||-0.066|-0.529|0.012
73823835|NCT01064414|147193269|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-0.635|-0.174|||ANCOVA|||||-0.174|-0.635|<0.001
73823836|NCT01064414|147193270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.227|TWO_SIDED|95.0|0.73|3.77|||Regression, Logistic|||||3.77|0.73|0.227
73823837|NCT01064414|147193270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69||||0.017|TWO_SIDED|95.0|1.19|6.04|||Regression, Logistic|||||6.04|1.19|0.017
73823838|NCT01064414|147193271|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|6.638||0.021|TWO_SIDED|95.0|-28.45|-2.307|||ANCOVA|||||-2.307|-28.45|0.021
73823839|NCT01064414|147193271|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|6.683||0.069|TWO_SIDED|95.0|-25.36|0.962|||ANCOVA|||||0.962|-25.36|0.069
73823840|NCT00249873|147193272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0133||95.0|0.81|0.98||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of any component of the primary event for the clopidogrel group compared with the Placebo group.|||0.98|0.81|0.0133
73823841|NCT00249873|147193273|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||<|0.001||95.0|0.62|0.83||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of stroke for the clopidogrel group compared with the Placebo group.|||0.83|0.62|<0.001
73823842|NCT00249873|147193274|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.696||95.0|0.89|1.08||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the clopidogrel group compared with the Placebo group.|||1.08|0.89|0.696
73823843|NCT00249873|147193275|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73823844|NCT00643201|147193278|NON_INFERIORITY_OR_EQUIVALENCE|Statistical Testing: non-inferiority tested at 1-sided α=0.025 with margin of 1.8. Demonstration of non-inferiority using both relative risk (RR) (margin = 1.8) and risk difference (RD) (margin = 0.035) were required to achieve the primary objective.|Risk Ratio (RR)|0.839|||<|0.0001|TWO_SIDED|95.0|0.5965|1.1802||This is the first test in a sequential testing sequence. p-value calculated based on the Yanagawa-Tango-Hiejima test stratified by index event strata for non-inferiority. Tested at 1-sided α=0.025|Yanagawa-Tango-Hiejima|For a successful trial; rejection of the null hypotheses for both RR and RD was required.||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatal PE)/VTE-related death.||1.1802|0.5965|<0.0001
73823845|NCT00643201|147193278|NON_INFERIORITY_OR_EQUIVALENCE|Statistical Testing; non-inferiority tested at 1-sided α=0.025. If non-inferiority demonstrated for both RR and RD, the primary objective was achieved.|Risk Difference (RD)|-0.0044|||<|0.0001|TWO_SIDED|95.0|-0.0128|0.004||Yanagawa-Tango-Hiejima test statistic for risk difference (RD).|Yanagawa-Tango-Hiejima|||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatalPE)/VTE-related death as measured by risk difference.||0.0040|-0.0128|<0.0001
73823846|NCT00643201|147193278|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.839||||0.3128|TWO_SIDED|95.0|0.5965|1.1802||Tested at 2-sided α=0.05 significance. Further inferential statistical testing halted due to failure to reject the null hypothesis of equivalence for VTE/VTE-related death.|Cochran-Mantel-Haenszel|Relative risk, CI, and p-value were calculated based on CMH test stratified by index event strata.||Hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing required demonstration of non-inferiority using both RR and RD plus demonstration of superiority for major bleeding.||1.1802|0.5965|0.3128
73823847|NCT00643201|147193279|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8151||||0.1554|TWO_SIDED|95.0|0.6146|1.0812||The test was stratified by index event strata using alpha=0.05 level of significance. Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.|Cochran-Mantel-Haenszel|Nominal p-value is reported.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.0812|0.6146|0.1554
73823848|NCT00643201|147193280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7994||||0.1848|TWO_SIDED|95.0|0.5737|1.1137||The test was stratified by index event strata using alpha=0.05 level of significance. . Nominal p-value is reported.|Cochran-Mantel-Haenszel|Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.1137|0.5737|0.1848
73823849|NCT00643201|147193281|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6236||||0.0011|TWO_SIDED|95.0|0.4682|0.8306||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.8306|0.4682|0.0011
73823850|NCT00643201|147193282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5532|||<|0.0001|TWO_SIDED|95.0|0.4658|0.6569||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6569|0.4658|<0.0001
73823851|NCT00643201|147193283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6347|||||TWO_SIDED|95.0|0.3735|1.0787|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.0787|0.3735|
73823852|NCT00643201|147193284|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0935|||||TWO_SIDED|95.0|0.6363|1.8793|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.8793|0.6363|
73823853|NCT00643201|147193285|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7521|||||TWO_SIDED|95.0|0.356|1.5889|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.5889|0.3560|
73823854|NCT00643201|147193286|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6539|||||TWO_SIDED|95.0|0.3419|1.2508|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.2508|0.3419|
73823855|NCT00643201|147193287|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7934|||||TWO_SIDED|95.0|0.5287|1.1906|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.1906|0.5287|
73823856|NCT00643201|147193288|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.307|||<|0.0001|TWO_SIDED|95.0|0.1728|0.5452||p-value calculated on the CMH test stratified by index event strata.|Cochran-Mantel-Haenszel||Relative risk and CI were calculated based on CMH test stratified by index event strata.|Hypothesis: apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. As per the hierarchical statistical testing cascade, inferential testing for adjudicated major bleeding occurred because non-inferiority for VTE/VTE-related death (Primary efficacy endpoint) was demonstrated earlier. Rejection of the null hypothesis for equivalence for major bleeding allowed inferential testing for superiority of VTE/VTE-related death.||0.5452|0.1728|<0.0001
73823857|NCT00643201|147193289|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.441|||<|0.0001|TWO_SIDED|95.0|0.3566|0.5453||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing was not conducted because the null hypothesis pertaining to superiority for VTE/VTE-related death was not rejected.||0.5453|0.3566|<0.0001
73823858|NCT00643201|147193290|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4793|||<|0.0001|TWO_SIDED|95.0|0.3815|0.6022||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6022|0.3815|<0.0001
73823859|NCT00643201|147193291|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6182|||<|0.0001|TWO_SIDED|95.0|0.5432|0.7034||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.7034|0.5432|<0.0001
73823860|NCT00643201|147193292|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5937|||<|0.0001|TWO_SIDED|95.0|0.5318|0.6629||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6629|0.5318|<0.0001
73823861|NCT02976519|147193301|OTHER||Slope|1.2705|STANDARD_ERROR_OF_MEAN|0.0801|||TWO_SIDED|95.0|1.1067|1.4343|||||Based on the estimate for slope parameter (β), a 2-sided 95% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.4343|1.1067|
73823862|NCT02976519|147193301|OTHER||Slope|1.1361|STANDARD_ERROR_OF_MEAN|0.0859|||TWO_SIDED|95.0|0.9598|1.3123|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.3123|0.9598|
73823863|NCT02976519|147193302|OTHER||Slope|1.2743|STANDARD_ERROR_OF_MEAN|0.0739|||TWO_SIDED|95.0|1.1231|1.4255|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.4255|1.1231|
73823864|NCT02976519|147193302|OTHER||Slope|1.0924|STANDARD_ERROR_OF_MEAN|0.0793|||TWO_SIDED|95.0|0.9296|1.2551|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.2551|0.9296|
73823865|NCT02346708|147193304|SUPERIORITY||Mean Difference (Final Values)|-2.07||||0.1|TWO_SIDED|95.0|-4.56|0.42||We determined whether there was a significant group difference between the real and sham treated PD-MCI patients on the DRS-2 change following rTMS using mixed model regression (MMR) to fit longitudinal models.|Mixed Models Analysis|degrees of freedom: 46||We estimated a sample size of 20 per group would provide at least 80% power at a significance level of 0.05 to detect a between-group difference of 10 on the Matthis Dementia Rating Scale-2, an effect size similar to prior studies of rivastigmine.||0.42|-4.56|0.1
73823866|NCT00928434|147193305|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as a lower bound (LCL) of the 95% confidence interval for the difference between the intermittent and pooled continuous treatments, CADT, (intermittent - continuous) of greater than -12.5%.|Percentage difference|1.57|||||TWO_SIDED|95.0|-0.19|3.33||||||||3.33|-0.19|
73823867|NCT00313846|147193365|SUPERIORITY_OR_OTHER|||||||0.0026|||||||Kaplan-Meier estimate mean|||||||.0026
73823868|NCT02038179|147193368|SUPERIORITY|||||||0.83||||||Intent-to-Treat Analysis using multiple imputation. Imputed Means and Imputed Standard Errors of the Mean.|paired t-test|||||||0.83
73823869|NCT02038179|147193369|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
73823870|NCT02038179|147193370|SUPERIORITY|||||||0.84|||||||paired t-test|||||||0.84
73823871|NCT02221648|147193371|SUPERIORITY_OR_OTHER|||||||0.447|||||||Fisher Exact|||||||0.4470
73823872|NCT02221648|147193372|SUPERIORITY_OR_OTHER|||||||0.0293|||||||Fisher Exact|||||||0.0293
73823873|NCT02221648|147193373|SUPERIORITY_OR_OTHER|||||||0.0448|||||||Fisher Exact|||||||0.0448
73823874|NCT02937623|147193376|OTHER||Least square mean difference|-0.44|||<|0.0001||95.0|-0.591|-0.297|||ANCOVA|ANCOVA model: change from baseline in Schiff sensitivity score as response and treatment as factors and baseline Schiff sensitivity score as covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-0.297|-0.591|<.0001
73823875|NCT02533934|147193382|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.01|||||||Kruskal-Wallis|||APRI change from baseline to last follow-up||||<.01
73823876|NCT02533934|147193382|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.01|||||||Kruskal-Wallis|||APRI change from baseline to last follow-up||||<.01
73823877|NCT02533934|147193382|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance|||||<|0.01|||||||Kruskal-Wallis|||FIB4 change from baseline to last follow-up||||<.01
73823878|NCT02533934|147193382|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance|||||<|0.01|||||||Kruskal-Wallis|||FIB4 change from baseline to last follow-up||||<.01
73823879|NCT02533934|147193384|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.001|||||||Wilcoxon (Signed Rank Test)|||||||<0.001
73823880|NCT01922258|147193385|SUPERIORITY||Treatment Difference|-2.34|||=|0.1454|TWO_SIDED|95.0|-5.49|0.82|||Mixed-effect model repeated measure|||||0.82|-5.49|=0.1454
73823881|NCT04552132|147193394|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
73823882|NCT04552132|147193395|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73823883|NCT04552132|147193396|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
73823884|NCT04552132|147193397|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73823885|NCT04552132|147193398|SUPERIORITY|||||||0.57|||||||Fisher Exact|||||||0.57
73823886|NCT04552132|147193399|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.60
73823887|NCT04552132|147193400|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73823888|NCT04552132|147193401|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73823889|NCT04552132|147193402|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
73823890|NCT04552132|147193403|SUPERIORITY|||||||0.4993|||||||Chi-squared|||||||.4993
73823891|NCT04552132|147193404|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
73823892|NCT04552132|147193405|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
73823893|NCT02256839|147193406|EQUIVALENCE|A 2x2 contingency table with 95% CI.|2 x 2 contingency table|98.1|||||TWO_SIDED|95.0|95.3|99.3||||||||99.3|95.3|
73823894|NCT02256839|147193406|EQUIVALENCE|A 2x2 contingency table with 95% CI|2 x 2 contingency table|96.1|||||TWO_SIDED|95.0|85.4|99.3||||||||99.3|85.4|
73823895|NCT00121719|147193423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146|||||||Wilcoxon signed-rank test|||This was a pilot study and a statistical sample size calculation was not performed.||||0.0146
73823896|NCT00382785|147193443|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED|95.0|||||univariate analysis|||Power calculation indicated that 60 subjects would be needed. Null Hypothesis: There will be no difference in perceived social support based on type of online support group (moderated or peer-led).||||.315
73823897|NCT00382785|147193444|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||univariate analysis|Null Hypothesis: There will be no difference between the moderated and peer-led groups based on type of online support (moderated; peer-led)||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in depressive symptoms based on type of online support group (moderated or peer-led).||||.23
73823898|NCT00382785|147193445|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|95.0|||||Univariate Analysis|||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in quality of life (QOL) based on type of online support group (moderated or peer-led).||||.32
73823899|NCT04346199|147193460|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.758|||||TWO_SIDED|95.0|0.323|1.722||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.722|0.323|
73823900|NCT04346199|147193468|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.967||||||95.0|0.69|1.353|||Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.353|0.690|
73823901|NCT01705977|147193481|OTHER||Difference in percentage versus placebo|0.1|||||TWO_SIDED|95.0|-0.31|0.51|||||95% Confidence Interval was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.51|-0.31|
73823902|NCT01705977|147193482|OTHER||Difference in percentage versus placebo|-0.35|||||TWO_SIDED|95.0|-1.55|0.85|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.85|-1.55|
73823903|NCT01705977|147193482|OTHER||Difference in percentage versus placebo|-0.7|||||TWO_SIDED|95.0|-1.6|0.2|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.20|-1.60|
73823904|NCT01705977|147193482|OTHER||Difference in percentage versus placebo|0.0|||||TWO_SIDED|95.0|-0.31|0.31|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.31|
73823905|NCT01705977|147193482|OTHER||Difference in percentage versus placebo|0.05|||||TWO_SIDED|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.21|
73823906|NCT01705977|147193482|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.58|0.02|
73823907|NCT01705977|147193482|OTHER||Difference in percentage versus placebo|0.26|||||TWO_SIDED|95.0|-0.44|0.96|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.96|-0.44|
73823908|NCT01705977|147193482|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.61|-0.01|
73823909|NCT01705977|147193484|OTHER||Difference in percentage versus placebo|-0.45|||||TWO_SIDED|95.0|-1.03|0.13|||||95% CI was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.13|-1.03|
73823910|NCT01705977|147193485|OTHER||Difference in percentage versus placebo|-0.75|||||TWO_SIDED|95.0|-2.02|0.51|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.51|-2.02|
73823911|NCT01705977|147193485|OTHER||Difference in percentage versus placebo|-1.0|||||TWO_SIDED|95.0|-1.96|-0.04|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.|||-0.04|-1.96|
73823912|NCT01705977|147193485|OTHER||Difference in percentage versus placebo|-0.1|||||TWO_SIDED|95.0|-0.44|0.24|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.24|-0.44|
73823913|NCT01705977|147193485|OTHER||Difference in percentage versus placebo|0.05|||||TWO_SIDED|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.21|
73823914|NCT01705977|147193485|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.58|0.02|
73823915|NCT01705977|147193485|OTHER||Difference in percentage versus placebo|0.31|||||TWO_SIDED|95.0|-0.42|1.05|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.|||1.05|-0.42|
73823916|NCT01705977|147193485|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.61|-0.01|
73823917|NCT01705977|147193487|OTHER||Odds ratio versus placebo|1.3||||0.0284|TWO_SIDED|95.0|1.03|1.65|||Regression, Logistic||95% CI and P-value was calculated from a logistic regression model for the comparison between belimumab and placebo including treatment group, Baseline prednisone dose, screening SELENA SLEDAI score (\<=9 versus \>=10) and region|||1.65|1.03|0.0284
73823918|NCT03066830|147193490|SUPERIORITY||Difference in Least Square (LS) Mean|-0.76|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-0.946|-0.574|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.574|-0.946|< 0.0001
73823919|NCT03066830|147193491|SUPERIORITY||Difference in LS Means|-1.608|STANDARD_ERROR_OF_MEAN|0.286|<|0.0001|TWO_SIDED|95.0|-2.1685|-1.0471|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-1.0471|-2.1685|< 0.0001
73823920|NCT03066830|147193492|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|1.272||0.5172|TWO_SIDED|95.0|-3.316|1.669|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening and country as fixed effects, and baseline SBP as a covariate.||1.669|-3.316|0.5172
73823921|NCT03066830|147193493|SUPERIORITY||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.983||0.2994|TWO_SIDED|95.0|-2.946|0.907|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥ 30 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.907|-2.946|0.2994
73823922|NCT03066830|147193494|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.267|<|0.0001|TWO_SIDED|95.0|-1.932|-0.884|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.884|-1.932|< 0.0001
73823923|NCT03066830|147193495|SUPERIORITY||Percentage difference|6.7||||0.0004|TWO_SIDED|95.0|3.03|10.47|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130,≥130 mmHg) at screening, randomization strata of metformin use at the screening. Missing data at Week 26 were assigned a status of non-responder in the analysis.||10.47|3.03|0.0004
73823924|NCT03066830|147193496|SUPERIORITY||Percentage difference|17.4|||<|0.0001|TWO_SIDED|95.0|11.16|23.73|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization strata of Metformin use at screening. Missing data at Week 26 were assigned a status of non-responder in the analysis.||23.73|11.16|< 0.0001
73823925|NCT01401543|147193580|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric Least Squares (LS) Mean Ratio|0.96|||||TWO_SIDED|90.0|0.91|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.01|0.91|
73823926|NCT01401543|147193580|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.89|||||TWO_SIDED|90.0|0.85|0.93|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.93|0.85|
73823927|NCT01401543|147193580|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.88|0.97|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.97|0.88|
73823928|NCT01401543|147193580|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.86|0.95|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.95|0.86|
73823929|NCT01401543|147193580|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.9|0.99|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.99|0.90|
73823930|NCT01401543|147193580|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.07|0.97|
73823931|NCT01401543|147193581|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.84|||||TWO_SIDED|90.0|0.77|0.91|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.91|0.77|
73823932|NCT01401543|147193581|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.78|||||TWO_SIDED|90.0|0.71|0.85|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.85|0.71|
73823933|NCT01401543|147193581|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.85|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.01|0.85|
73823934|NCT01401543|147193581|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.77|||||TWO_SIDED|90.0|0.7|0.84|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.84|0.70|
73823935|NCT01401543|147193581|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.91|||||TWO_SIDED|90.0|0.84|1.0|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.00|0.84|
73823936|NCT01401543|147193581|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.91|1.08|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.08|0.91|
73823937|NCT01401543|147193582|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05||||||||1.05|0.93|
73823938|NCT01401543|147193582|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0||||||||1.00|0.89|
73823939|NCT01401543|147193582|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||||1.02|0.90|
73823940|NCT01401543|147193582|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||||1.02|0.90|
73823941|NCT01401543|147193582|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
73823942|NCT01401543|147193582|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||||1.08|0.95|
73823943|NCT01401543|147193583|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.72|||||TWO_SIDED|90.0|0.68|0.77|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.77|0.68|
73823944|NCT01401543|147193583|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.71|||||TWO_SIDED|90.0|0.66|0.76|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.76|0.66|
73823945|NCT01401543|147193583|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.05|0.92|
73823946|NCT01401543|147193583|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.69|||||TWO_SIDED|90.0|0.65|0.74|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.74|0.65|
73823947|NCT01401543|147193583|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.02|0.90|
73823948|NCT01401543|147193583|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.91|1.04|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.04|0.91|
73823949|NCT00823134|147193698|OTHER||Mean Difference (Final Values)|2.8|STANDARD_DEVIATION|4.7||0.021|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.021
73823950|NCT00823134|147193699|OTHER|The number of events found per category (PSG and ApneaLink Plus recording) will be compared. Events are Apneas and Hypopneas per hour of sleep, measured as Apnea-Hypopnea-Index (AHI), Apnea-Index (AI), Obstructive AI, Central AI, Hypopnea-Index (HI) and Oxygen Desaturation Index (ODI).|Correlation coefficient (Bland-Altman)|0.75|||||TWO_SIDED|||||||||Per recording, the number of events found per category with PSG and ApneaLink Plus will be compared. As a summary, all PSG values and all ApneaLink Plus values per category will be collected in one graph (Bland-Altmann Plot). The correlation coefficient will be calculated per category. A correlation of \>75% will be seen as threshold for validity.||||
73823951|NCT00078403|147193705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||||||P-value is pre-specified 1-sided test that PEG slows liver fibrosis progression. Accrual and follow-up on Arms A and B were halted at interim review for lack of fibrosis progression in Arm B (control arm). P-value is unadjusted for interim analysis.|Exact Wilcoxon rank sum test|||Accrual and follow-up on Arms A and B were halted for futility at the first independent interim review of the primary endpoint conducted on May 2, 2007.||||0.58
73823952|NCT02291029|147193723|SUPERIORITY||Mean Difference (Net)|-0.41||||0.397|TWO_SIDED|95.0|-3.7|2.89||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||2.89|-3.70|0.397
73823953|NCT02291029|147193723|SUPERIORITY||Mean Difference (Net)|-5.21||||0.009|TWO_SIDED|95.0|-9.46|-0.96||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.||||-0.96|-9.46|0.009
73823954|NCT02291029|147193723|SUPERIORITY||Mean Difference (Net)|2.34||||0.344|TWO_SIDED|95.0|-2.78|7.45||two-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.||||7.45|-2.78|0.344
73823955|NCT02291029|147193724|SUPERIORITY||Mean Difference (Net)|-1.09||||0.205|TWO_SIDED|95.0|-2.97|0.8|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||0.80|-2.97|0.205
73823956|NCT02291029|147193724|SUPERIORITY||Mean Difference (Net)|-0.95||||0.188|TWO_SIDED|95.0|-2.41|0.5|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||0.50|-2.41|0.188
73823957|NCT02291029|147193724|SUPERIORITY||Mean Difference (Net)|-0.37||||0.663|TWO_SIDED|95.0|-2.08|1.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||1.35|-2.08|0.663
73823958|NCT02291029|147193725|SUPERIORITY||Mean Difference (Net)|-15.26||||0.161|TWO_SIDED|95.0|-37.9|7.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||7.38|-37.90|0.161
73823959|NCT02291029|147193725|SUPERIORITY||Mean Difference (Net)|-12.16||||0.017|TWO_SIDED|95.0|-21.94|-2.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||-2.38|-21.94|0.017
73823960|NCT02291029|147193726|SUPERIORITY||Mean Difference (Net)|-9.45||||0.456|TWO_SIDED|95.0|-36.2|17.3|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||17.30|-36.20|0.456
73823961|NCT02291029|147193726|SUPERIORITY||Mean Difference (Net)|-8.14||||0.376|TWO_SIDED|95.0|-26.67|10.39|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||10.39|-26.67|0.376
73823962|NCT02291029|147193727|SUPERIORITY||Mean Difference (Net)|-5.5||||0.172|TWO_SIDED|95.0|-13.91|2.91|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||2.91|-13.91|0.172
73823963|NCT02291029|147193727|SUPERIORITY||Mean Difference (Net)|3.83||||0.175|TWO_SIDED|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||9.48|-1.81|0.175
73823964|NCT02291029|147193728|SUPERIORITY||Mean Difference (Net)|-0.07||||0.986|TWO_SIDED|95.0|-8.49|8.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||8.35|-8.49|0.986
73823965|NCT02291029|147193728|SUPERIORITY||Mean Difference (Net)|3.83||||0.175|TWO_SIDED|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||9.48|-1.81|0.175
73823966|NCT02291029|147193729|SUPERIORITY||Mean Difference (Net)|1.34||||0.807|TWO_SIDED|95.0|-10.48|13.15|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||13.15|-10.48|0.807
73823967|NCT02291029|147193729|SUPERIORITY||Mean Difference (Net)|-9.83||||0.074|TWO_SIDED|95.0|-20.66|1.01|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||1.01|-20.66|0.074
73823968|NCT04155463|147193767|OTHER||Median Percent Change|-18.4||||0.17|TWO_SIDED||||||Wilcoxon signed rank test|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for all participants. Interquartile range for this was -37.4 to 29.8.|Based on previous pesticide research, we calculated a sample size of 40 participants to provide a power of 0.80 at a 0.05 significance level in a two-sided test. We assumed a standard deviation of 0.5 µg/L.||||0.17
73823969|NCT04155463|147193767|OTHER||Median Percent Change|-24.2||||0.06|TWO_SIDED||||||Wilcoxon signed rank test|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for far-field participants. Interquartile range for this was -37.4 to -8.8.|||||0.06
73823970|NCT04155463|147193767|OTHER||Median Percent Change|1.4||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for near-field participants. Interquartile range for this was -41.9 to 43.0.|||||0.83
73823971|NCT04547140|147193806|SUPERIORITY||Difference in percentages|3.3|||||TWO_SIDED|||||||||Percentage of Participants Dying||||
73823972|NCT04547140|147193806|SUPERIORITY||Difference in percentages|6.4|||||TWO_SIDED|||||||||Percentage of Participants Requiring ICU Admission||||
73823973|NCT04547140|147193807|SUPERIORITY||Difference in percentages|6.9|||||TWO_SIDED|||||||||Percentage of Participants Who are Dependent on High Flow Oxygen Devices||||
73823974|NCT04547140|147193807|SUPERIORITY||Difference in percentages|3.4|||||TWO_SIDED|||||||||Percentage of Participants Who are Dependent on Invasive Mechanical Ventilation||||
73823975|NCT04547140|147193808|SUPERIORITY||Least Squares (LS) Mean Difference|1.22||||0.1453|TWO_SIDED|95.0|-0.43|2.87||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 15||2.87|-0.43|0.1453
73823976|NCT04547140|147193808|SUPERIORITY||LS Mean Difference|0.21||||0.8015|TWO_SIDED|95.0|-1.44|1.86||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 29||1.86|-1.44|0.8015
73823977|NCT04547140|147193810|SUPERIORITY||LS Mean Difference of Duration|1.48||||0.5135|TWO_SIDED|95.0|-3.04|6.0||P-value was calculated using an analysis of variance (ANOVA) model, including the length of hospital stay (days) as a dependent variable and treatment group as a fixed effect.|ANOVA|||||6.00|-3.04|0.5135
73823978|NCT04547140|147193811|SUPERIORITY||LS Mean Difference of Duration|3.41||||0.1221|TWO_SIDED|95.0|-0.94|7.76||P-value was calculated using an ANOVA model, including the number of days in the ICU as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.76|-0.94|0.1221
73823979|NCT04547140|147193812|SUPERIORITY||LS Mean Difference of Duration|2.78||||0.3329|TWO_SIDED|95.0|-2.92|8.48||P-value was calculated using an ANOVA model, including the number of days on oxygen as a dependent variable and treatment group as a fixed effect.|ANOVA|||||8.48|-2.92|0.3329
73823980|NCT04547140|147193813|SUPERIORITY||LS Mean Difference of Duration|3.48||||0.1092|TWO_SIDED|95.0|-0.81|7.77||P-value was calculated using an ANOVA model, including the number of days on mechanical ventilation as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.77|-0.81|0.1092
73823981|NCT04547140|147193814|SUPERIORITY||LS Mean Difference|-0.63||||0.1189|TWO_SIDED|95.0|-1.43|0.17||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 15||0.17|-1.43|0.1189
73823982|NCT04547140|147193814|SUPERIORITY||LS Mean Difference|-0.85||||0.0341|TWO_SIDED|95.0|-1.64|-0.07||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 29||-0.07|-1.64|0.0341
73823983|NCT04547140|147193818|SUPERIORITY||Difference in percentages|1.9||||0.8809|TWO_SIDED|95.0|-24.1|28.3||P-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentages of participants experiencing sustained normalization of fever.|Chi-squared|||||28.3|-24.1|0.8809
73823984|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|1.0|1.03|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.03|1.00|
73823985|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.01|0.99|
73823986|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.03|0.99|
73823987|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.04|1.00|
73823988|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.01|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.01|0.98|
73823989|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|0.95|0.97|1.02|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.02|0.97|
73823990|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.97|1.01|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.01|0.97|
73823991|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.98|1.05|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.05|0.98|
73823992|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.99|
73823993|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.98|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.98|
73823994|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.97|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.97|
73823995|NCT04110314|147193826|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.04|1.00|
73823996|NCT01004978|147193903|SUPERIORITY|||||||0.4||||||one-sided p-value|Cochran-Mantel-Haenszel|||||||0.4
73823997|NCT01004978|147193904|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
73823998|NCT01711983|147193913|NON_INFERIORITY|Non-inferiority margin based on 1) the lower 95% confidence bound (= 0.82) for estimated 6-month composite Clinical Success for the historical device (219/253=0.866), and 2) a worst-case analysis of 6-month composite Clinical Success for the historical device (0.81, assuming the 18 subjects with missing echo evaluations were failures).|Risk Difference (RD)|-0.0366|||<|0.0001|ONE_SIDED|95.0||0.007||A priori 1-sided alpha = 0.05.|2-sample binomial proportions test||Difference is control - test. Confidence interval is the upper one-sided 95% Wald confidence interval.|"Test null hypothesis of inferiority of test device (test) compared to historical device (control).~H0: Pc - Pt ≥ Δ vs H1: Pc - Pt \< Δ, where Pt and Pc are true proportions of 6-month clinical success for test and control, respectively, and Δ is the non-inferiority margin.~Given Nc = 253, then Nt = 135 test subjects provides 86% power to reject H0 with 95% confidence if Δ = 0.10 and Pc = Pt = 0.866 under H0."||0.007||<0.0001
73823999|NCT02326272|147193920|SUPERIORITY||Odds Ratio (OR)|33.405|||<|0.0001|TWO_SIDED|97.5|9.965|111.983||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) placebo (PBO).|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||111.983|9.965|<0.0001
73824000|NCT02326272|147193920|SUPERIORITY||Estimated difference in responder rate|69.7|||||TWO_SIDED|95.0|57.12|82.36|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||82.36|57.12|
73824001|NCT02326272|147193920|SUPERIORITY||Odds Ratio (OR)|36.212|||<|0.0001|TWO_SIDED|97.5|10.686|122.713||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||122.713|10.686|<0.0001
73824002|NCT02326272|147193920|SUPERIORITY||Estimated difference in responder rate|71.0|||||TWO_SIDED|95.0|58.47|83.43|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||83.43|58.47|
73824003|NCT02326272|147193921|SUPERIORITY||Odds Ratio (OR)|106.225|||<|0.0001|TWO_SIDED|97.5|9.572|1178.843||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||1178.843|9.572|<0.0001
73824004|NCT02326272|147193921|SUPERIORITY||Estimated difference in responder rate|64.8|||||TWO_SIDED|95.0|52.16|77.46|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||77.46|52.16|
73824005|NCT02326272|147193921|SUPERIORITY||Odds Ratio (OR)|133.163|||<|0.0001|TWO_SIDED|97.5|11.904|1489.578||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||1489.578|11.904|<0.0001
73824006|NCT02326272|147193921|SUPERIORITY||Estimated difference in responder rate|69.6|||||TWO_SIDED|95.0|57.48|81.77|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||81.77|57.48|
73824007|NCT02326272|147193922|SUPERIORITY||Odds Ratio (OR)|24.283|||<|0.0001|TWO_SIDED|97.5|4.386|134.432||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||134.432|4.386|<0.0001
73824008|NCT02326272|147193922|SUPERIORITY||Estimated difference in responder rate|48.1|||||TWO_SIDED|95.0|35.04|61.26|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||61.26|35.04|
73824009|NCT02326272|147193922|SUPERIORITY||Odds Ratio (OR)|27.204|||<|0.0001|TWO_SIDED|97.5|4.895|151.198||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||151.198|4.895|<0.0001
73824010|NCT02326272|147193922|SUPERIORITY||Estimated difference in responder rate|51.0|||||TWO_SIDED|95.0|37.75|64.19|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||64.19|37.75|
73824011|NCT02326272|147193925|SUPERIORITY||Adjusted Mean Treatment Differences|-6.62|||<|0.0001|TWO_SIDED|97.5|-8.88|-4.36||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-4.36|-8.88|<0.0001
73824012|NCT02326272|147193925|SUPERIORITY||Adjusted Mean Treatment Differences|-6.19|||<|0.0001|TWO_SIDED|97.5|-8.46|-3.93||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-3.93|-8.46|<0.0001
73824013|NCT00737100|147193935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94||||0.001||95.0|1.19|4.7||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||4.70|1.19|0.001
73824014|NCT00737100|147193935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39||||0.0001||95.0|1.67|5.12||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||5.12|1.67|0.0001
73824015|NCT00737100|147193936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.0184||95.0|0.38|4.11||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||4.11|0.38|0.0184
73824016|NCT00737100|147193936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.0179||95.0|0.38|4.06||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||4.06|0.38|0.0179
73824017|NCT00737100|147193937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.83||||0.0756||95.0|-0.19|3.86|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||3.86|-0.19|0.0756
73824018|NCT00737100|147193937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.12||||0.0023||95.0|1.12|5.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||5.12|1.12|0.0023
73824019|NCT00737100|147193938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.3857||95.0|-1.08|2.79|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||2.79|-1.08|0.3857
73824020|NCT00737100|147193938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.2199||95.0|-0.72|3.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||3.11|-0.72|0.2199
73824021|NCT00737100|147193939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.19||||0.0363||95.0|0.27|8.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||8.11|0.27|0.0363
73824022|NCT00737100|147193939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.34||||0.0073||95.0|1.45|9.23|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||9.23|1.45|0.0073
73824023|NCT00737100|147193940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.7414||95.0|-0.06|0.08|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||0.08|-0.06|0.7414
73824024|NCT00737100|147193940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.1418||95.0|-0.02|0.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||0.12|-0.02|0.1418
73824025|NCT00737100|147193941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.8515||95.0|0.37|1.72|||Regression, Logistic|Covariates of treatment and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||1.72|0.37|0.8515
73824026|NCT00737100|147193941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.5565||95.0|0.33|1.59|||Regression, Logistic|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||1.59|0.33|0.5565
73824027|NCT04033146|147193966|OTHER||||||<|0.001||||||Threshold was 0.05|ANOVA|||"H1. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for young adults.~H2. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for older adults."||||<0.001
73824028|NCT00871234|147194053|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.03||||0.36||95.0|||||Wilcoxon signed-rank|||||||0.36
73824029|NCT01261390|147194134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.677|STANDARD_ERROR_OF_MEAN|1.652|||TWO_SIDED|95.0|-5.915|0.561|||||Presented average of the treatment effects on 24hr SBP at 6months and 12months: (6mo + 12mo)/ 2; Comparison: ActivePAP Control. Adjusted for randomization factors (CVD; site; sleepstudy type) with subjectspecific slopes and intercepts.|"We conducted a linear mixed effects regression (LMER) to estimate the treatment effect of CPAP on mean 24hour Systolic Blood Pressure (SBP). Timepoint, treatment, and the timepoint\* treatment interaction were included as fixed effects, as were randomization stratification factors. Subject was included as a random effect. Let: y = observed SBP; β = fixed effects; u = random effects; X = known design matrix; Z = vector of subjects~Then our model is:~y = Xβ + Zu + ε"||0.561|-5.915|
73824030|NCT01261390|147194135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.0||||0.003|TWO_SIDED||||||Mixed Models Analysis|Adjusted for intervention and study duration (number of nights), and randomization (CVD; site; diagnostic sleep study type; PAP device type).|Estimated value is minutes of use per night.|We performed a mixed effects analysis of the effect of Motivational Enhancement (ME) on nightly CPAP adherence. Our model included every night of data and adjusted for intervention and study duration (number of nights), as well as randomization stratification factors (CVD; site; diagnostic sleepstudy type; PAP device type).||||0.003
73824031|NCT01691378|147194197|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.03|TWO_SIDED|95.0|0.52|8.3|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BHS compared bet arms controlling for T1 BHS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BHS as function of arm \& T1 BHS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||8.3|.52|.03
73824032|NCT01691378|147194197|SUPERIORITY||Mean Difference (Final Values)|-4.6||||0.01|TWO_SIDED|95.0|-7.9|-1.3|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||-1.3|-7.9|.01
73824033|NCT01691378|147194197|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.0007|TWO_SIDED|95.0|-9.3|-3.2|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||-3.2|-9.3|.0007
73824034|NCT01691378|147194198|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.07|TWO_SIDED|95.0|-0.29|8.0|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BSS compared bet arms controlling for T1 BSS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BSS as function of arm \& T1 BSS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||8.0|-.29|.07
73824035|NCT01691378|147194198|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.94|TWO_SIDED|95.0|-3.3|3.1|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||3.1|-3.3|.94
73824036|NCT01691378|147194198|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.06|TWO_SIDED|95.0|-7.0|0.12|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||.12|-7.0|.06
73824037|NCT01691378|147194199|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.13|TWO_SIDED|95.0|-1.7|12.9|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BDI compared bet arms controlling for T1 BDI. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BDI as function of arm \& T1 BDI. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||12.9|-1.7|.13
73824038|NCT01691378|147194199|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.003|TWO_SIDED|95.0|-13.8|-3.6|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||-3.6|-13.8|.003
73824039|NCT01691378|147194199|SUPERIORITY||Mean Difference (Final Values)|-11.6||||0.002|TWO_SIDED|95.0|-18.0|-5.3|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||-5.3|-18.0|.002
73824040|NCT00808067|147194213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0055|TWO_SIDED|95.0|0.64|0.93|||Regression, Cox|||||0.93|0.64|0.0055
73824041|NCT00808067|147194220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.5119|TWO_SIDED|95.0|0.84|1.42|||Regression, Cox|||||1.42|0.84|0.5119
73824042|NCT00808067|147194221|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.2371|TWO_SIDED|95.0|0.94|1.29|||Regression, Cox|||||1.29|0.94|0.2371
73824043|NCT00808067|147194222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5052|TWO_SIDED|95.0|0.89|1.27|||Regression, Cox|||||1.27|0.89|0.5052
73824044|NCT00808067|147194223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.2241||95.0|0.82|1.05|||Regression, Cox|||||1.05|0.82|0.2241
73824045|NCT00418028|147194246|NON_INFERIORITY_OR_EQUIVALENCE|"If we assume that the non-inferiority level is up to 15% lower (equivalent to a median progression-free time of 3 months), for a one-sided error α=0.05, and 80% power, are necessary 88 patients per group.~Considering an dropout rate of around 10%, the number of patients would be 98 per group."|Hazard Ratio (HR)|1.3||||0.1224|TWO_SIDED|95.0|0.9|1.7|||Log Rank|||||1.7|0.9|0.1224
73824046|NCT00418028|147194247|SUPERIORITY|||||||0.8269|||||||Chi-squared|||||||0.8269
73824047|NCT00418028|147194248|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5703|TWO_SIDED|95.0|0.67|2.07|||Log Rank|||||2.07|0.67|0.5703
73824048|NCT00418028|147194249|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.4676|TWO_SIDED|95.0|0.83|1.5|||Log Rank|||||1.50|0.83|0.4676
73824049|NCT00418028|147194250|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.5688|TWO_SIDED|95.0|0.66|1.25|||Log Rank|||||1.25|0.66|0.5688
73824050|NCT00418028|147194251|SUPERIORITY|||||||0.4984|||||||Chi-squared|||||||0.4984
73824051|NCT00418028|147194252|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.2556|TWO_SIDED|95.0|0.88|1.63|||Log Rank|||||1.63|0.88|0.2556
73824052|NCT00490971|147194253|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 85.0% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0195.|Weighted Z- test|||Null hypothesis: there is no difference between Pali/Pali and Pali/Placebo in the time to recurrence of any mood symptoms related to bipolar I disorder. An interim analysis was performed when approximately 85% of the required number of recurrences were reported in Pali/Pali and Pali/Placebo treatment groups. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.||||0.017
73824053|NCT00490971|147194254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 81.9% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0198.|Weighted z-test|||At the time of interim analysis of the primary efficacy endpoint, the proportion of recurrence of manic symptoms was 81.9% of the number of recurrence of manic symptoms at final analysis. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.||||<0.001
73824054|NCT00490971|147194255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.53|1.46||Cox proportional hazards regression was performed with treatment (Pali/Placebo, Pali/Pali) as a factor. The 2 treatment groups were compared by means of a hazard ratio (Pali/Placebo: Pali/Pali)|Regression, Cox|The percent of participants who reported recurrence of depressive symptoms was: 18% Pali/Placebo, 24% Pali/Pali.|Hazard ratio was estimated with Pali/Placebo in the numerator and Pali/Pali in the denominator|||1.46|0.53|
73824055|NCT00490971|147194256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|||<|0.001|TWO_SIDED|95.0|-6.92|-1.98|||ANCOVA|ANCOVA model with treatment group (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||-1.98|-6.92|<0.001
73824056|NCT00490971|147194257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.763|TWO_SIDED|95.0|-1.87|2.55|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||2.55|-1.87|0.763
73824057|NCT00490971|147194258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7||||0.01|TWO_SIDED|95.0|1.4|10.09|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||10.09|1.40|0.010
73824058|NCT00490971|147194259|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|ANCOVA Model on ranks with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||||0.007
73824059|NCT02002871|147194274|SUPERIORITY_OR_OTHER|||||||0.0152|TWO_SIDED||||||t-test, 2 sided|||The statistical analysis was performed on the difference of the change from baseline of the Blue light treated plaque versus the Control plaque.||||0.0152
73824060|NCT04754542|147194290|NON_INFERIORITY|We performed a non-inferiority test for the proportions of the drug continuation and drug discontinuation arms experiencing a new MS relapse and/or MRI Brain Lesion over the course of the study duration. The non-inferiority margin used was 8%.|Difference in proportion|0.0121||||0.124|TWO_SIDED|95.0|-0.1321|0.1287|||Exact binomial test|Exact binomial test fr difference in two proportions||We tested the null hypothesis of inferiority with the proportion of disease events (i.e., new MS relapse and/or MRI brain lesion) for the drug discontinuation group being 8% greater than the proportion for the drug continuation group under the alternative that the two rates are equal.||0.1287|-0.1321|0.124
73824061|NCT04754542|147194291|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||||||0.639
73824062|NCT04754542|147194292|SUPERIORITY|||||||0.964|||||||t-test, 2 sided|||||||0.964
73824063|NCT04754542|147194293|SUPERIORITY|||||||0.819|||||||t-test, 2 sided|||||||0.819
73824064|NCT04754542|147194294|SUPERIORITY|||||||0.515|||||||t-test, 2 sided|||||||0.515
73824065|NCT04754542|147194295|SUPERIORITY|||||||0.388|||||||t-test, 2 sided|||||||0.388
73824066|NCT04754542|147194296|SUPERIORITY|||||||0.183|||||||t-test, 2 sided|||||||0.183
73824067|NCT04754542|147194297|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||||||0.414
73824068|NCT04754542|147194298|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||||||0.998
73824069|NCT04754542|147194299|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
73824070|NCT04754542|147194300|SUPERIORITY|||||||0.061|||||||t-test, 2 sided|||||||0.061
73824071|NCT04754542|147194301|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
73824072|NCT04754542|147194302|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||||||0.514
73824073|NCT04754542|147194303|SUPERIORITY|||||||0.017|||||||t-test, 2 sided|||||||0.017
73824074|NCT04754542|147194304|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
73824075|NCT04754542|147194305|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||||||0.358
73824076|NCT04754542|147194306|SUPERIORITY|||||||0.151|||||||t-test, 2 sided|||||||0.151
73824077|NCT04754542|147194307|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
73824078|NCT04754542|147194308|SUPERIORITY|||||||0.656|||||||Chi-squared|||||||0.656
73824079|NCT04754542|147194309|SUPERIORITY|||||||0.892|||||||Chi-squared|||||||0.892
73824080|NCT04754542|147194310|SUPERIORITY|||||||0.063|||||||Mantel Haenszel|Cochran-Mantel-Haenszel chi-square test for ordinal-nominal association was used||||||0.063
73824081|NCT01466361|147194321|SUPERIORITY_OR_OTHER||Least square mean difference|-7.23||||0.0643|TWO_SIDED|95.0|-14.89|0.44|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 1 minute post dosing.||0.44|-14.89|0.0643
73824082|NCT01466361|147194321|SUPERIORITY_OR_OTHER||Least square mean difference|-7.16||||0.1489|TWO_SIDED|95.0|-16.93|2.61|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 3 minute post dosing.||2.61|-16.93|0.1489
73824083|NCT01466361|147194321|SUPERIORITY_OR_OTHER||Least square mean difference|-6.33||||0.2225|TWO_SIDED|95.0|-16.56|3.9|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 5 minute post dosing.||3.90|-16.56|0.2225
73824084|NCT01466361|147194321|SUPERIORITY_OR_OTHER||Least square mean difference|-5.11||||0.3491|TWO_SIDED|95.0|-15.87|5.66|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 10 minutes post dosing.||5.66|-15.87|0.3491
73824085|NCT01466361|147194321|SUPERIORITY_OR_OTHER||Least square mean difference|-5.0||||0.3936|TWO_SIDED|95.0|-16.6|6.59|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 15 minutes post dosing.||6.59|-16.60|0.3936
73824086|NCT01466361|147194322|SUPERIORITY_OR_OTHER||Least square mean difference|-3.58||||0.3922|TWO_SIDED|95.0|-11.85|4.7|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, at 1 minute post dosing.||4.70|-11.85|0.3922
73824087|NCT01466361|147194322|SUPERIORITY_OR_OTHER||Least square mean difference|-9.7||||0.0547|TWO_SIDED|95.0|-19.59|0.2|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 3 minutes post dosing.||0.20|-19.59|0.0547
73824088|NCT01116921|147194334|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.006|TWO_SIDED|95.0|0.13|0.7|||Regression, Logistic|||||0.70|0.13|0.006
73824089|NCT03506438|147194357|SUPERIORITY||Mean Difference (Net)|-6.7||||0.018|TWO_SIDED|95.0|-12.2|-1.2|||Mixed Models Analysis|||||-1.2|-12.2|0.018
73824090|NCT03506438|147194358|SUPERIORITY||Mean Difference (Net)|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.1|||Mixed Models Analysis|||||1.1|-0.5|0.48
73824091|NCT03506438|147194359|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.73|TWO_SIDED|95.0|-1.4|1.0|||Mixed Models Analysis|||||1.0|-1.4|0.73
73824092|NCT03506438|147194360|SUPERIORITY||estimated mean difference|0.6||||0.47|TWO_SIDED|95.0|-1.0|2.1|||Mixed Models Analysis|||||2.1|-1.0|0.47
73824093|NCT03506438|147194361|SUPERIORITY||Odds Ratio (OR)|1.8||||0.29|TWO_SIDED|95.0|0.6|5.2|||Regression, Logistic|||||5.2|0.6|0.29
73824094|NCT03506438|147194362|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
73824095|NCT03506438|147194363|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
73824096|NCT03506438|147194364|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
73824097|NCT03527277|147194365|SUPERIORITY||Mean Difference (Net)|-1.5||||0.46|TWO_SIDED|95.0|-5.7|2.6|||ANCOVA|Effect of group on change in outcome with adjustment for BMI, Outcome at baseline and gender||||2.6|-5.7|0.46
73824098|NCT03527277|147194366|SUPERIORITY||Mean Difference (Net)|-0.1||||0.97|TWO_SIDED|95.0|-3.1|3.0|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||3.0|-3.1|0.97
73824099|NCT03527277|147194367|SUPERIORITY||Mean Difference (Net)|-0.7||||0.73|TWO_SIDED|95.0|-4.8|3.4|||ANCOVA|Effect of group with adjustment for gender and outcome and BMI at baseline.||||3.4|-4.8|0.73
73824100|NCT03527277|147194368|SUPERIORITY||Mean Difference (Net)|1.0||||0.54|TWO_SIDED|95.0|-2.2|4.2|||ANCOVA|Effect of group change with adjustment for gender and BMI and outcome at baseline.||||4.2|-2.2|0.54
73824101|NCT03527277|147194369|SUPERIORITY||Mean Difference (Net)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.49|||ANCOVA|Effect of group with adjustment for gender and BMI and outcome at baseline.||||-0.49|-1.34|<0.0001
73824102|NCT03527277|147194370|SUPERIORITY||Mean Difference (Net)|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.53|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||-0.53|-1.19|<0.0001
73824103|NCT03527277|147194371|SUPERIORITY||Mean Difference (Net)|-0.38||||0.18|TWO_SIDED|95.0|-0.94|0.18|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.18|-0.94|0.18
73824104|NCT03527277|147194372|SUPERIORITY||Mean Difference (Net)|0.2||||0.49|TWO_SIDED|95.0|-0.38|0.77|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.77|-0.38|0.49
73824105|NCT03527277|147194373|SUPERIORITY||Mean Difference (Net)|-1.8||||0.66|TWO_SIDED|95.0|-10.1|6.5|||ANCOVA|Effect of group on change with adjustment of gender and BMI and outcome at baseline.||||6.5|-10.1|0.66
73824106|NCT03527277|147194374|SUPERIORITY||Mean Difference (Net)|-0.06||||0.78|TWO_SIDED|95.0|-0.06|0.35|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||0.35|-0.06|0.78
73824107|NCT03527277|147194375|SUPERIORITY||Mean Difference (Net)|0.03||||0.91|TWO_SIDED|95.0|-0.58|0.64|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||0.64|-0.58|0.91
73824108|NCT03527277|147194378|SUPERIORITY||Mean Difference (Net)|-7.9||||0.11|TWO_SIDED|95.0|-17.6|1.8|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||1.8|-17.6|0.11
73824109|NCT03527277|147194379|SUPERIORITY||Mean Difference (Net)|23340.0||||0.0032|TWO_SIDED|95.0|8284.0|38396.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||38396|8284|0.0032
73824110|NCT03527277|147194380|SUPERIORITY||Mean Difference (Net)|5558.0||||0.0003|TWO_SIDED|95.0|2680.0|8437.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||8437|2680|0.0003
73824111|NCT03527277|147194381|SUPERIORITY||Mean Difference (Net)|3824.0||||0.0012|TWO_SIDED|95.0|1611.0|6036.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline||||6036|1611|0.0012
73824112|NCT03527277|147194382|SUPERIORITY||Mean Difference (Net)|19522.0||||0.0023|TWO_SIDED|95.0|7353.0|31691.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||31691|7353|0.0023
73824113|NCT03527277|147194383|SUPERIORITY||Mean Difference (Net)|21881.0||||0.0001|TWO_SIDED|95.0|11307.0|32455.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||32455|11307|0.0001
73824114|NCT03527277|147194384|SUPERIORITY||Mean Difference (Net)|9666.0||||0.0002|TWO_SIDED|95.0|4808.0|14524.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||14524|4808|0.0002
73824115|NCT03527277|147194385|SUPERIORITY||Mean Difference (Net)|3413.0||||0.0011|TWO_SIDED|95.0|1456.0|5370.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||5370|1456|0.0011
73824116|NCT03527277|147194386|SUPERIORITY||Mean Difference (Net)|11.6||||0.59|TWO_SIDED|95.0|-32.0|55.1|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||55.1|-32.0|0.59
73824117|NCT03527277|147194387|SUPERIORITY||Mean Difference (Net)|79.0||||0.028|TWO_SIDED|95.0|9.8|148.6|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||148.6|9.8|0.028
73824118|NCT03527277|147194389|SUPERIORITY||Mean Difference (Net)|-0.8||||0.17|TWO_SIDED|95.0|-1.94|0.35|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.35|-1.94|0.17
73824119|NCT03527277|147194390|SUPERIORITY||Mean Difference (Net)|0.54||||0.65|TWO_SIDED|95.0|-1.9|3.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||3.0|-1.9|0.65
73824120|NCT03527277|147194391|SUPERIORITY||Mean Difference (Net)|0.04||||0.88|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|Effect of group on change with adjustment for gender and outcome at baseline.||||0.6|-0.5|0.88
73824121|NCT03527277|147194392|SUPERIORITY||Mean Difference (Net)|0.6||||0.81|TWO_SIDED|95.0|-4.4|5.7|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||5.7|-4.4|0.81
73824122|NCT03527277|147194393|SUPERIORITY||Mean Difference (Net)|-0.7||||0.69|TWO_SIDED|95.0|-4.4|2.9|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||2.9|-4.4|0.69
73824123|NCT03527277|147194394|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|Effect of group on change with adjustment for gender and outcome at baseline.||||0.1|-1.0|0.10
73824124|NCT03934216|147194411|SUPERIORITY||Odds Ratio (OR)|0.9||||0.5935|TWO_SIDED|95.0|0.3|2.4|||Stratified Cochran-Mantel-Haenszel|||||2.4|0.3|0.5935
73824125|NCT03934216|147194412|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3051|TWO_SIDED|95.0|0.6|2.7|||Stratified Cochran-Mantel-Haenszel|||||2.7|0.6|0.3051
73824126|NCT03934216|147194413|SUPERIORITY||Odds Ratio (OR)|0.6||||0.8764|TWO_SIDED|95.0|0.3|1.4|||Stratified Cochran-Mantel-Haenszel|||||1.4|0.3|0.8764
73824127|NCT03934216|147194414|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2235|TWO_SIDED|95.0|0.5|3.8|||Stratified Cochran-Mantel-Haenszel|||||3.8|0.5|0.2235
73824128|NCT00735709|147194431|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.93|||<|0.001|TWO_SIDED|95.0|-6.99|-2.86||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||-2.86|-6.99|<0.001
73824129|NCT00735709|147194431|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.12|||<|0.001|TWO_SIDED|95.0|-6.17|-2.08||Hierarchical testing stopped at SDS total score at Week 8 in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-2.08|-6.17|<0.001
73824130|NCT00735709|147194431|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.52|||<|0.001|TWO_SIDED|95.0|-5.57|-1.47||This treatment arm is not in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.47|-5.57|<0.001
73824131|NCT00735709|147194432|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54||||0.135|TWO_SIDED|95.0|-3.56|0.48||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||0.48|-3.56|0.135
73824132|NCT00735709|147194432|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.11||||0.263|TWO_SIDED|95.0|-3.07|0.84|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||0.84|-3.07|0.263
73824133|NCT00735709|147194432|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.963|TWO_SIDED|95.0|-2.03|1.94|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||1.94|-2.03|0.963
73824134|NCT00735709|147194433|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|||<|0.001|TWO_SIDED|95.0|-0.8|-0.3|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.30|-0.80|<0.001
73824135|NCT00735709|147194433|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.71|-0.22|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.22|-0.71|<0.001
73824136|NCT00735709|147194433|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.23|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.23|-0.72|<0.001
73824137|NCT00735709|147194434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.348|||<|0.001|TWO_SIDED|95.0|1.995|5.618|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo.|||5.618|1.995|<0.001
73824138|NCT00735709|147194434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.739|||<|0.001|TWO_SIDED|95.0|1.631|4.598|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo|||4.598|1.631|<0.001
73824139|NCT00735709|147194434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.018|||<|0.001|TWO_SIDED|95.0|1.799|5.063|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo|||5.063|1.799|<0.001
73824140|NCT00735709|147194435|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.59||||0.001|TWO_SIDED|95.0|-7.34|-1.84|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.84|-7.34|0.001
73824141|NCT00735709|147194435|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.47||||0.002|TWO_SIDED|95.0|-7.32|-1.62|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.62|-7.32|0.002
73824142|NCT00735709|147194435|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.13||||0.004|TWO_SIDED|95.0|-6.9|-1.37|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.37|-6.90|0.004
73824143|NCT00735709|147194436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.951||||0.026|TWO_SIDED|95.0|1.082|3.517|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.517|1.082|0.026
73824144|NCT00735709|147194436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.056||||0.015|TWO_SIDED|95.0|1.15|3.673|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.673|1.150|0.015
73824145|NCT00735709|147194436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.753||||0.062|TWO_SIDED|95.0|0.973|3.158|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.158|0.973|0.062
73824146|NCT01165307|147194457|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
73824147|NCT01165307|147194458|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 Physical Scale.||||0.82
73824148|NCT01165307|147194458|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 mental scale.||||0.11
73824149|NCT01165307|147194459|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
73824150|NCT01165307|147194460|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
73824151|NCT01165307|147194461|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
73824152|NCT01165307|147194462|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
73824153|NCT01165307|147194463|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
73824154|NCT01165307|147194467|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
73824155|NCT02492802|147194469|OTHER|||||||0.77|||||||The Wald Type III test|||||||0.77
73824156|NCT03113968|147194487|NON_INFERIORITY|The Farrington-Manning score test was used to assess the noninferiority of KET.|||||<|0.001|||||||The Farrington-Manning score test|||||||<.001
73824157|NCT03113968|147194488|SUPERIORITY||Mean Difference (Net)|9.3|||||TWO_SIDED||||||||||P-values not reported|||
73824158|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|7451.0|||||TWO_SIDED|95.0|5857.0|9045.0|||||The mean predicted cost for inpatient services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||9045|5857|
73824159|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|11545.0|||||TWO_SIDED|95.0|8827.0|14263.0|||||The mean predicted cost for inpatient services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||14263|8827|
73824160|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|61.0|||||TWO_SIDED|95.0|58.0|63.0|||||The mean predicted cost for emergency department visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||63|58|
73824161|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|51.0|||||TWO_SIDED|95.0|49.0|53.0|||||The mean predicted cost for emergency department visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||53|49|
73824162|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|231.0|||||TWO_SIDED|95.0|227.0|234.0|||||The mean predicted cost for office visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||234|227|
73824163|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|295.0|||||TWO_SIDED|95.0|290.0|299.0|||||The mean predicted cost for office visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||299|290|
73824164|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|873.0|||||TWO_SIDED|95.0|827.0|919.0|||||The mean predicted cost for other outpatient and ancillary services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||919|827|
73824165|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|1080.0|||||TWO_SIDED|95.0|1022.0|1138.0|||||The mean predicted cost for other outpatient and ancillary services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1138|1022|
73824166|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|1267.0|||||TWO_SIDED|95.0|1251.0|1283.0|||||The mean predicted cost for pharmacy services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1283|1251|
73824167|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|1250.0|||||TWO_SIDED|95.0|1234.0|1266.0|||||The mean predicted cost for pharmacy services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1266|1234|
73824168|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|1175.0|||||TWO_SIDED|95.0|1083.0|1267.0|||||The mean predicted cost for inpatient and emergency department services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1267|1083|
73824169|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|1566.0|||||TWO_SIDED|95.0|1438.0|1695.0|||||The mean predicted cost for inpatient and emergency department services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1695|1438|
73824170|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|2991.0|||||TWO_SIDED|95.0|2922.0|3059.0|||||The mean predicted cost for total healthcare services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||3059|2922|
73824171|NCT01387178|147194489|SUPERIORITY_OR_OTHER||Adjusted Mean|3304.0|||||TWO_SIDED|95.0|3221.0|3386.0|||||The mean predicted cost for total healthcare services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||3386|3221|
73824172|NCT01387178|147194490|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.964||||0.2198||95.0|0.909|1.022||Risk of Moderate COPD Exacerbations|Regression, Cox|||||1.022|0.909|0.2198
73824173|NCT01387178|147194490|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.0406||95.0|0.752|0.994||Risk of Severe COPD Exacerbations|Regression, Cox|||||0.994|0.752|0.0406
73824174|NCT01387178|147194490|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.0962||95.0|0.901|1.009||Risk of Any COPD Exacerbation|Regression, Cox|||||1.009|0.901|0.0962
73824175|NCT04805671|147194492|SUPERIORITY||Risk Difference (RD)|-8.7||||0.0047|TWO_SIDED|95.0|-14.71|-2.67|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-2.67|-14.71|0.0047
73824176|NCT04805671|147194497|SUPERIORITY||Risk Difference (RD)|-11.3||||0.0007|TWO_SIDED|95.0|-17.86|-4.81|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-4.81|-17.86|0.0007
73824177|NCT04805671|147194498|SUPERIORITY||Risk Difference (RD)|-8.7||||0.0047|TWO_SIDED|95.0|-14.71|-2.67|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-2.67|-14.71|0.0047
73824178|NCT04805671|147194499|SUPERIORITY||Risk Difference (RD)|-11.3||||0.0007|TWO_SIDED|95.0|-17.86|-4.81|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-4.81|-17.86|0.0007
73824179|NCT04805671|147194500|SUPERIORITY||Hazard Ratio (HR)|1.237||||0.0938|TWO_SIDED|95.0|0.964|1.586|||Regression, Cox|||ADG20 vs. Placebo||1.586|0.964|0.0938
73824180|NCT04805671|147194501|SUPERIORITY||Hazard Ratio (HR)|0.137||||0.0361|TWO_SIDED|95.0|0.016|1.162|||Regression, Cox|||ADG20 vs Placebo||1.162|0.016|0.0361
73824181|NCT04805671|147194502|SUPERIORITY||Hazard Ratio (HR)|1.255||||0.0781|TWO_SIDED|95.0|0.974|1.617|||Regression, Cox|||ADG20 vs Placebo||1.617|0.974|0.0781
73824182|NCT04805671|147194503|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.4976|TWO_SIDED|95.0|-0.66|0.32|||ANCOVA|||ADG20 vs. Placebo||0.32|-0.66|0.4976
73824183|NCT04805671|147194504|SUPERIORITY||Hazard Ratio (HR)|1.048||||0.7239|TWO_SIDED|95.0|0.806|1.364|||Regression, Cox|||||1.364|0.806|0.7239
73824184|NCT04805671|147194505|SUPERIORITY||Risk Difference (RD)|-11.1||||0.0364|TWO_SIDED|95.0|-21.42|-0.7|||Regression, Logistic|||||-0.70|-21.42|0.0364
73824185|NCT04805671|147194506|SUPERIORITY||Risk Difference (RD)|8.2||||0.0227|TWO_SIDED|95.0|1.15|15.31||The p-value and risk difference reported was calculated based on the Day 5 timepoint.|Regression, Logistic|||||15.31|1.15|0.0227
73824186|NCT04805671|147194507|SUPERIORITY||Mean Difference (Final Values)|-6.93||||0.1124|TWO_SIDED|95.0|-15.49|1.64|||ANCOVA|||||1.64|-15.49|0.1124
73824187|NCT01246895|147194538|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||||||0.017
73824188|NCT01246895|147194539|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||||||0.026
73824189|NCT01246895|147194540|SUPERIORITY_OR_OTHER|||||||0.474|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Pain||||0.474
73824190|NCT01246895|147194540|SUPERIORITY_OR_OTHER|||||||0.236|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Stiffness||||0.236
73824191|NCT01246895|147194540|SUPERIORITY_OR_OTHER|||||||0.326|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Physical function||||0.326
73824192|NCT01246895|147194541|SUPERIORITY_OR_OTHER|||||||0.01|||||||Physical count|||||||0.01
73824193|NCT01246895|147194542|SUPERIORITY_OR_OTHER|||||||0.478|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Physical component||||0.478
73824194|NCT01246895|147194542|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Mental component||||0.125
73824195|NCT01871077|147194552|OTHER|||||||0.89|||||||Friedman test|||||||0.890
73824196|NCT01871077|147194553|OTHER|||||||0.078|||||||Wilcoxon (Mann-Whitney)|||||||0.078
73824197|NCT01871077|147194554|OTHER|||||||1|||||||Friedman test|||||||1.000
73824198|NCT01871077|147194555|OTHER|||||||0.497|||||||Wilcoxon (Mann-Whitney)|||||||.497
73824199|NCT04878120|147194556|SUPERIORITY|||||||0.733||||||For interaction between study group and intervention|ANOVA|||"The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. To test the hypothesis that HCL Control with Smart Bolus Calculator reduces exposure to hypoglycemia with respect to Standard HCL Control, a mixed ANOVA was performed with LBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor."||||0.733
73824200|NCT04878120|147194557|SUPERIORITY|||||||0.824||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent below 70 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.824
73824201|NCT04878120|147194558|SUPERIORITY|||||||0.402||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent in 70-180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.402
73824202|NCT04878120|147194559|SUPERIORITY|||||||0.3||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent above 180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.300
73824203|NCT04878120|147194560|SUPERIORITY|||||||0.168||||||For interaction between study arm and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with HBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.168
73824204|NCT04878120|147194561|SUPERIORITY|||||||0.476||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with CGM coefficient of variation as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.476
73824205|NCT04878120|147194562|SUPERIORITY|||||||0.914||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with total amount of carbohydrate administered as rescue treatments as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.914
73824206|NCT02493517|147194659|NON_INFERIORITY|The non-inferiority margin is defined as 0.6 SDS for the upper limit of 95% CI of the LS mean difference of the log-transformed IGF-1 SDS without back-transformation.|Treatment difference|-0.32|||||TWO_SIDED|95.0|-0.74|0.11||||||"The Least Square (LS) Means and 95% Confidence Intervals (CIs) were based on the generalised linear model (GLM) with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The treatment difference (lanreotide Autogel - lanreotide PR) is presented."||0.11|-0.74|
73824207|NCT02493517|147194659|NON_INFERIORITY|The non-inferiority margin for the back-transformed LS Mean ratio of IGF-1 SDS of lanreotide Autogel versus lanreotide PR is exp (0.6) = 1.822.|LS Mean ratio|0.73|||||TWO_SIDED|95.0|0.48|1.11||||||"The LS Means and 95% CIs were based on the GLM with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The LS Mean ratio (lanreotide Autogel versus lanreotide PR) is presented."||1.11|0.48|
73824208|NCT02493517|147194660|OTHER||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|-5.2|17.7||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of normal IGF-1 SDS values at EOST/EW Visit is presented.||17.7|-5.2|
73824209|NCT02493517|147194661|OTHER||Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-17.5|14.4||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤2.5 mcg/L at EOST/EW Visit is presented.||14.4|-17.5|
73824210|NCT02493517|147194662|OTHER||Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-8.9|12.0||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤1 mcg/L at EOST/EW Visit is presented.||12.0|-8.9|
73824211|NCT02493517|147194663|OTHER||Risk Difference (RD)|4.7|||||TWO_SIDED|95.0|-3.1|12.5||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage subjects with normal IGF-1 levels and who have GH levels \>1 mcg/L and ≤2.5 mcg/L at EOST/EW Visit is presented.||12.5|-3.1|
73824212|NCT02493517|147194664|OTHER||Treatment difference|3.63|STANDARD_DEVIATION|21.6|||TWO_SIDED|95.0|-3.98|11.25||||||Treatment difference (lanreotide Autogel - lanreotide PR) is presented.||11.25|-3.98|
73824213|NCT02493517|147194665|OTHER||Risk Difference (RD)|-5.5|||||TWO_SIDED|95.0|-24.3|13.3||||||Risk difference (lanreotide Autogel - lanreotide PR) in the percentage of subjects with at least 20% reduction in the solid component of tumour volume compared to Baseline is presented.||13.3|-24.3|
73824214|NCT03718429|147194668|SUPERIORITY|In line with recommendations for pilot investigations, since there were no preliminary data exploring the pharmacodynamic effects of vascular dose rivaroxaban in addition to antiplatelet therapy, we arbitrarily chose a sample size of 20 patients per treatment cohort.||||||0.275|||||||Wilcoxon (Mann-Whitney)|||||||0.275
73824215|NCT03718429|147194669|SUPERIORITY|||||||0.488|||||||Wilcoxon (Mann-Whitney)|||||||0.488
73824216|NCT03718429|147194670|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73824217|NCT05404711|147194685|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
73824218|NCT05404711|147194686|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
73824219|NCT05404711|147194687|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
73824220|NCT05404711|147194688|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
73824221|NCT05404711|147194689|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
73824222|NCT05404711|147194690|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
73824223|NCT05404711|147194691|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
73824224|NCT05404711|147194692|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
73824225|NCT05404711|147194693|OTHER|Spearman correlation analysis|Spearman correlation rho|0.18||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and HbA1c.||||0.3
73824226|NCT05404711|147194693|OTHER|Spearman correlation analysis|Spearman correlation rho|0.5||||0.005|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and HbA1c.||||0.005
73824227|NCT05404711|147194693|OTHER|Spearman correlation analysis|Spearman correlation rho|0.46||||0.01|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and HbA1c.||||0.01
73824228|NCT05404711|147194693|OTHER|Spearman correlation analysis|Spearman correlation rho|0.23||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and HbA1c.||||0.2
73824229|NCT05404711|147194693|OTHER|Spearman correlation analysis|Spearman correlation rho|0.14||||0.5|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and HbA1c.||||0.5
73824230|NCT05404711|147194693|OTHER|Spearman correlation analysis|Spearman correlation rho|0.29||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose (mg/dL) and HbA1c.||||0.1
73824231|NCT05404711|147194693|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.15||||0.4|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM correlation of variability (CV) and HbA1c.||||0.4
73824232|NCT05404711|147194693|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.06||||0.7|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation and HbA1c.||||0.7
73824233|NCT05404711|147194694|OTHER|Spearman correlation analysis|Spearman correlation rho|0.25||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and laboratory-OGTT fasting glucose.||||0.2
73824234|NCT05404711|147194694|OTHER|Spearman correlation analysis|Spearman correlation rho|0.19||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT fasting glucose.||||0.3
73824235|NCT05404711|147194694|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.1||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT and lab-OGTT fasting glucose.||||0.6
73824236|NCT05404711|147194694|OTHER|Spearman correlation analysis|Spearman correlation rho|0.19||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT fasting glucose.||||0.3
73824237|NCT05404711|147194694|OTHER|Spearman correlation analysis|Spearman correlation rho|0.09||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT fasting glucose.||||0.6
73824238|NCT05404711|147194694|OTHER|Spearman correlation analysis|Spearman correlation rho|0.35||||0.05|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT fasting glucose.||||0.05
73824239|NCT05404711|147194694|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.18||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT fasting glucose.||||0.3
73824240|NCT05404711|147194694|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.07||||0.7|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT fasting glucose.||||0.7
73824241|NCT05404711|147194695|OTHER|Spearman correlation analysis|Spearman correlation rho|0.1||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and lab-OGTT 2-hour glucose.||||0.6
73824242|NCT05404711|147194695|OTHER|Spearman correlation analysis|Spearman correlation rho|0.31||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT 2-hour glucose.||||0.1
73824243|NCT05404711|147194695|OTHER|Spearman correlation analysis|Spearman correlation rho|0.25||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and lab-OGTT 2-hour glucose.||||0.2
73824244|NCT05404711|147194695|OTHER|Spearman correlation analysis|Spearman correlation rho|0.26||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT 2-hour glucose.||||0.2
73824245|NCT05404711|147194695|OTHER|Spearman correlation analysis|Spearman correlation rho|0.27||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT 2-hour glucose.||||0.2
73824246|NCT05404711|147194695|OTHER|Spearman correlation analysis|Spearman correlation rho|0.31||||0.08|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT 2-hour glucose.||||0.08
73824247|NCT05404711|147194695|OTHER|Spearman correlation analysis|Spearman correlation rho|0.15||||0.4|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT 2-hour glucose.||||0.4
73824248|NCT05404711|147194695|OTHER|Spearman correlation analysis|Spearman correlation rho|0.28||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT 2-hour glucose.||||0.1
73824249|NCT00325819|147194696|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.053|TWO_SIDED|95.0|0.41|1.01|||unadjusted Poisson regression|||The study sample size of 1000 children was selected to have 80% power to detect a 30% reduction in risk of the primary outcome of rectal temperature \>=38 following vaccination. In 2009, during the enrollment period of our trial, another paper reported the results of a randomized trial of acetaminophen prophylaxis in infants which found significantly lower immune responses to various vaccines in the acetaminophen group. In light of thse findings we elected to stop enrollment in our trial.||1.01|0.41|0.053
73824250|NCT00325819|147194697|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.08||95.0|||||Fisher Exact|||||||0.08
73824251|NCT00325819|147194698|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31||||0.02|TWO_SIDED|95.0|0.12|0.84|||unadjusted Poisson regression|||||0.84|0.12|0.02
73824252|NCT00325819|147194699|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45||||0.14|TWO_SIDED|95.0|0.16|1.28|||unadjusted Poisson regression|||||1.28|0.16|0.14
73824253|NCT00325819|147194700|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.001|TWO_SIDED|95.0|0.25|0.7|||unadjusted Poisson regression|||||0.70|0.25|0.001
73824254|NCT00325819|147194701|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.4|TWO_SIDED|95.0|0.21|1.88|||unadjusted Poisson regression|||||1.88|0.21|0.40
73824255|NCT00325819|147194702|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.25|3.94|||unadjusted Poisson regression|||||3.94|0.25|1.00
73824256|NCT00325819|147194703|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.94||||0.18|TWO_SIDED|95.0|0.6|14.34|||unadjusted Poisson regression|||||14.34|0.60|0.18
73824257|NCT00593450|147194728|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-3.9|2.9||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin Monthly Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.9|-3.9|0.16
73824258|NCT00593450|147194728|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.16|TWO_SIDED|99.2|-4.1|2.4||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis as Needed Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.4|-4.1|0.16
73824259|NCT00593450|147194728|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|1.5||0.16|TWO_SIDED|99.2|-4.7|1.3||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||1.3|-4.7|0.16
73896533|NCT03456882|147326403|SUPERIORITY||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|3.7||0.4239|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.4239
73896534|NCT03456882|147326404|SUPERIORITY|||||||0.1708||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.1708
73824260|NCT00593450|147194728|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.9||0.16|TWO_SIDED|99.2|-5.7|1.6||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||1.6|-5.7|0.16
73824261|NCT00593450|147194728|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-4.5|2.1||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.1|-4.5|0.16
73824262|NCT00593450|147194728|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-5.9|0.8||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||0.8|-5.9|0.16
73824263|NCT03574974|147194799|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
73824264|NCT03430856|147194807|NON_INFERIORITY|Change from baseline in HbA1c at 24 weeks of treatment, was analyzed using mixed model for repeated measures (MMRM) where all available post-baseline HbA1c measurements obtained up to Week 24 was entered as the dependent variables; visit and treatment were included as fixed factors, with Baseline HbA1c and stratification factor variables as covariates. Furthermore, the interaction terms of visit by treatment, visit by stratification factors and visit by Baseline HbA1c were included in the model.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.502|1.47|||||Insulin Tregopil 45 mg - Insulin Aspart|||1.470|0.502|
73824265|NCT03430856|147194807|NON_INFERIORITY|Non inferiority margin is 0.4%|Mean Difference (Net)|0.89|||||TWO_SIDED|95.0|0.414|1.37|||||Insulin Tregopil 30mg - Insulin Aspart|||1.370|0.414|
73824266|NCT04265261|147194850|SUPERIORITY||Risk Difference (RD)|1.19||||0.8586|TWO_SIDED|95.0|-11.86|14.23|||Cochran-Mantel-Haenszel|||||14.23|-11.86|0.8586
73824267|NCT04265261|147194850|SUPERIORITY||Risk Difference (RD)|-2.93||||0.6388|TWO_SIDED|95.0|-15.18|9.31|||Cochran-Mantel-Haenszel|||||9.31|-15.18|0.6388
73824268|NCT03877224|147194855|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.16||||0.07905|TWO_SIDED|95.0|0.36|6.01||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, weeks impacted by COVID-19 and treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint KCCQ-TSS, the following hypothesis was tested using the significance level 0.04990 • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-TSS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||6.01|0.36|0.07905
73824269|NCT03877224|147194856|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.12||||0.23215|TWO_SIDED|95.0|-0.09|5.37||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, weeks impacted by COVID-19 and treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint KCCQ-PLS, the following hypothesis was tested at significant level of 0.00005 • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-PLS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||5.37|-0.09|0.23215
73824270|NCT03877224|147194857|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|1.6||||0.66801|TWO_SIDED|95.0|-5.9|9.0||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint 6MWD, the following hypothesis was tested using the significance level 0.00005: H0: m(r(A)) = m(r(C)) versus H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, 6MWD, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||9.0|-5.9|0.66801
73824271|NCT03877224|147194858|SUPERIORITY|Total time spent in LVPA was not tested for statistical significance and the p-value is considered nominal because the test for 6MWD was not statistically significant.|Hodges-Lehmann median diff. vs placebo|0.19||||0.12523|TWO_SIDED|95.0|-0.06|0.48|||Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||For the secondary efficacy endpoint, total time spent in LVPA, the testing hypothesis is • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in secondary efficacy endpoint, total time spent in LVPA, from baseline to End of study among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||0.48|-0.06|0.12523
73824272|NCT01001429|147194878|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Logistic|||||||0.04
73824273|NCT01001429|147194878|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Regression, Linear|||UMSS scores with subjects propofol vs. Dexmetomidine group||||0.68
73824274|NCT03150082|147194927|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.88|||||TWO_SIDED|90.0|91.13|103.0|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||103.00|91.13|
73824275|NCT03150082|147194928|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|93.16|||||TWO_SIDED|90.0|86.09|100.82|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||100.82|86.09|
73824276|NCT03150082|147194929|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.96|||||TWO_SIDED|90.0|91.17|103.11|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||103.11|91.17|
73824277|NCT03150082|147194930|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.||||||0.3499||||||"P value was analyzed using a nonparametric Wilcoxon signed-rank test."|Wilcoxon signed-rank test|||||||0.3499
73824278|NCT01718483|147194952|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.7|-1.01|||Mixed Models Repeated Measures Analysis|||||-1.01|-1.70|<0.001
73824279|NCT01718483|147194953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73824280|NCT01718483|147194954|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
73824281|NCT01718483|147194955|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-6.35|||<|0.001|TWO_SIDED|95.0|-7.17|-5.54|||Mixed Models Repeated Measures Analysis|||||-5.54|-7.17|<0.001
73824282|NCT01718483|147194956|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-7.4|||<|0.001|TWO_SIDED|95.0|-8.93|-5.88|||Mixed Models Repeated Measures Analysis|||||-5.88|-8.93|<0.001
73824283|NCT01718483|147194957|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.199|||<|0.001|TWO_SIDED|95.0|-0.31|-0.088|||ANCOVA|||||-0.088|-0.310|<0.001
73824284|NCT01718483|147194958|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.211|||<|0.001|TWO_SIDED|95.0|-0.33|-0.092|||ANCOVA|||||-0.092|-0.330|<0.001
73824285|NCT01718483|147194959|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02||||0.308|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||||0.02|-0.07|0.308
73824286|NCT01718483|147194960|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel|||||||<0.001
73824287|NCT01718483|147194961|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.77|||<|0.001|TWO_SIDED|95.0|-2.24|-1.3||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-1.30|-2.24|<0.001
73824288|NCT01718483|147194962|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.65|||<|0.001|TWO_SIDED|95.0|0.72|2.57||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating||2.57|0.72|<0.001
73824289|NCT01718483|147194962|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.19|||<|0.001|TWO_SIDED|95.0|-4.98|-3.39||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating||-3.39|-4.98|<0.001
73824290|NCT01718483|147194962|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.7|||<|0.001|TWO_SIDED|95.0|-5.49|-3.91||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger||-3.91|-5.49|<0.001
73824291|NCT01718483|147194963|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-10.32|||<|0.001|TWO_SIDED|95.0|-12.43|-8.21||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-8.21|-12.43|<0.001
73824292|NCT01718483|147194964|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.31||||0.706|TWO_SIDED|95.0|-1.93|1.31||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA|||||1.31|-1.93|0.706
73824293|NCT00536510|147194986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|1.96|<|0.001||95.0|-18.6|-10.9||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The primary hypothesis of superiority of MK0524A 2 g to placebo in lowering Low Density Lipoprotein Cholesterol (LDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.||-10.9|-18.6|<0.001
73824294|NCT00536510|147194987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.9|STANDARD_ERROR_OF_MEAN|1.68|<|0.001||95.0|12.6|19.2||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The secondary hypothesis of superiority of MK0524A 2 g to placebo in lowering High Density Lipoprotein Cholesterol (HDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.||19.2|12.6|<0.001
73824295|NCT00048035|147194996|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.38|||||TWO_SIDED|90.0|0.32|0.42|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb.|All cohorts with dosing frequency 1 X / Week||0.42|0.32|
73824296|NCT00048035|147194996|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.61|||||TWO_SIDED|90.0|0.53|0.76|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb change.|All cohorts with dosing frequency 1 X /2 Week||0.76|0.53|
73824297|NCT02035553|147195019|SUPERIORITY||Diff in MMRM LSM|-1.84||||0.0451|TWO_SIDED|95.0|-3.64|-0.04|||Mixed Models Analysis|||||-0.04|-3.64|0.0451
73824298|NCT02185417|147195046|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.45|TWO_SIDED|95.0|0.94|1.16|||Log Rank|||Primary analyses were performed with the use of unadjusted log-rank tests that were stratified according to VA health care system.||1.16|0.94|0.45
73824299|NCT00974311|147195053|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.53|0.75|||Log Rank|Stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.75|0.53|<0.0001
73824300|NCT00974311|147195054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.35|0.47|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.47|0.35|<0.0001
73824301|NCT00974311|147195055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.0001|TWO_SIDED|95.0|0.566|0.835|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.835|0.566|0.0001
73824302|NCT00974311|147195056|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|24.9|||<|0.0001|TWO_SIDED|95.0|18.8|30.9|||Cochran-Mantel-Haenszel|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Confidence Interval based on standard normal approximation.|||30.9|18.8|<0.0001
73824303|NCT00974311|147195057|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.248|||<|0.0001|TWO_SIDED|95.0|0.204|0.303||Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Log Rank||Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.303|0.204|<0.0001
73824304|NCT00974311|147195058|SUPERIORITY_OR_OTHER||Difference in Rate of Pain Palliation|38.2||||0.0079|TWO_SIDED|95.0|19.4|57.0|||Cochran-Mantel-Haenszel|Stratified by baseline Eastern Cooperative Oncology Group performance status (0-1 vs. 2).|Confidence Interval based on standard normal approximation.|||57.0|19.4|0.0079
73824305|NCT05556148|147195068|OTHER||Mean Difference (Final Values)|-1.54||||0.2968|TWO_SIDED|95.0|-4.44|1.37|||Student's paired t-test|||Change from Baseline at Day 1||1.37|-4.44|0.2968
73824306|NCT05556148|147195068|OTHER||Mean Difference (Final Values)|-15.36|||<|0.0001|TWO_SIDED|95.0|-19.77|-10.95|||Student's paired t-test|||Change from Baseline at Day 2||-10.95|-19.77|<.0001
73824307|NCT05556148|147195068|OTHER||Mean Difference (Final Values)|-27.27|||<|0.0001|TWO_SIDED|95.0|-33.06|-21.49|||Student's paired t-test|||Change from Baseline at Day 3||-21.49|-33.06|<.0001
73824308|NCT05556148|147195068|OTHER||Mean Difference (Final Values)|-35.05|||<|0.0001|TWO_SIDED|95.0|-41.69|-28.41|||Student's paired t-test|||Change from Baseline at Day 4||-28.41|-41.69|<.0001
73824309|NCT05556148|147195068|OTHER||Mean Difference (Final Values)|-38.49|||<|0.0001|TWO_SIDED|95.0|-45.87|-31.11|||Student's paired t-test|||Change from Baseline at Day 5||-31.11|-45.87|<.0001
73824310|NCT05556148|147195068|OTHER||Mean Difference (Final Values)|-39.67|||<|0.0001|TWO_SIDED|95.0|-48.46|-30.88|||Student's paired t-test|||Change from Baseline at Day 6||-30.88|-48.46|<.0001
73824311|NCT05556148|147195068|OTHER||Mean Difference (Final Values)|-52.6|||<|0.0001|TWO_SIDED|95.0|-63.69|-41.51|||Student's paired t-test|||Change from Baseline at Day 7||-41.51|-63.69|<.0001
73824312|NCT05556148|147195069|OTHER||Mean Difference (Final Values)|0.29||||0.7112|TWO_SIDED|95.0|-1.27|1.86|||Student's paired t-test|||Change from Baseline at Day 1||1.86|-1.27|0.7112
73824313|NCT05556148|147195069|OTHER||Mean Difference (Final Values)|-6.21|||<|0.0001|TWO_SIDED|95.0|-8.51|-3.92|||Student's paired t-test|||Change from Baseline at Day 2||-3.92|-8.51|<.0001
73824314|NCT05556148|147195069|OTHER||Mean Difference (Final Values)|-12.11|||<|0.0001|TWO_SIDED|95.0|-15.0|-9.22|||Student's paired t-test|||Change from Baseline at Day 3||-9.22|-15.00|<.0001
73824315|NCT05556148|147195069|OTHER||Mean Difference (Final Values)|-15.98|||<|0.0001|TWO_SIDED|95.0|-19.24|-12.71|||Student's paired t-test|||Change from Baseline at Day 4||-12.71|-19.24|<.0001
73824316|NCT05556148|147195069|OTHER||Mean Difference (Final Values)|-19.44|||<|0.0001|TWO_SIDED|95.0|-23.29|-15.59|||Student's paired t-test|||Change from Baseline at Day 5||-15.59|-23.29|<.0001
73824317|NCT05556148|147195069|OTHER||Mean Difference (Final Values)|-19.36|||<|0.0001|TWO_SIDED|95.0|-24.03|-14.69|||Student's paired t-test|||Change from Baseline at Day 6||-14.69|-24.03|<.0001
73824318|NCT05556148|147195069|OTHER||Mean Difference (Final Values)|-25.4|||<|0.0001|TWO_SIDED|95.0|-31.87|-18.93|||Student's paired t-test|||Change from Baseline at Day 7||-18.93|-31.87|<.0001
73824319|NCT05556148|147195070|OTHER||Mean Difference (Final Values)|-1.83||||0.0481|TWO_SIDED|95.0|-3.64|-0.02|||Student's paired t-test|||Change from Baseline at Day 1||-0.02|-3.64|0.0481
73824320|NCT05556148|147195070|OTHER||Mean Difference (Final Values)|-9.14|||<|0.0001|TWO_SIDED|95.0|-11.74|-6.55|||Student's paired t-test|||Change from Baseline at Day 2||-6.55|-11.74|<.0001
73824321|NCT05556148|147195070|OTHER||Mean Difference (Final Values)|-15.16|||<|0.0001|TWO_SIDED|95.0|-18.44|-11.88|||Student's paired t-test|||Change from Baseline at Day 3||-11.88|-18.44|<.0001
73824322|NCT05556148|147195070|OTHER||Mean Difference (Final Values)|-19.07|||<|0.0001|TWO_SIDED|95.0|-22.84|-15.3|||Student's paired t-test|||Change from Baseline at Day 4||-15.30|-22.84|<.0001
73824323|NCT05556148|147195070|OTHER||Mean Difference (Final Values)|-19.05|||<|0.0001|TWO_SIDED|95.0|-23.35|-14.75|||Student's paired t-test|||Change from Baseline at Day 5||-14.75|-23.35|<.0001
73824324|NCT05556148|147195070|OTHER||Mean Difference (Final Values)|-20.31|||<|0.0001|TWO_SIDED|95.0|-25.7|-14.92|||Student's paired t-test|||Change from Baseline at Day 6||-14.92|-25.70|<.0001
73824325|NCT05556148|147195070|OTHER||Mean Difference (Final Values)|-27.2|||<|0.0001|TWO_SIDED|95.0|-32.48|-21.92|||Student's paired t-test|||Change from Baseline at Day 7||-21.92|-32.48|<.0001
73824326|NCT05556148|147195071|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.31|0.31|||Student's paired t-test|||Change from Baseline at Day 1||0.31|-0.31|1.0000
73824327|NCT05556148|147195071|OTHER||Mean Difference (Final Values)|-0.63||||0.0003|TWO_SIDED|95.0|-0.97|-0.3|||Student's paired t-test|||Change from Baseline at Day 2||-0.30|-0.97|0.0003
73824328|NCT05556148|147195071|OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Student's paired t-test|||Change from Baseline at Day 3||-0.70|-1.50|<.0001
73824329|NCT05556148|147195071|OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.24|||Student's paired t-test|||Change from Baseline at Day 4||-1.24|-2.20|<.0001
73824330|NCT05556148|147195071|OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.16|||Student's paired t-test|||Change from Baseline at Day 5||-1.16|-2.33|<.0001
73824331|NCT05556148|147195071|OTHER||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.51|-1.28|||Student's paired t-test|||Change from Baseline at Day 6||-1.28|-2.51|<.0001
73824332|NCT05556148|147195071|OTHER||Mean Difference (Final Values)|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.29|-1.64|||Student's paired t-test|||Change from Baseline at Day 7||-1.64|-3.29|<.0001
73824333|NCT05556148|147195072|OTHER||Mean Difference (Final Values)|-0.39||||0.0023|TWO_SIDED|95.0|-0.64|-0.14|||Student's paired t-test|||Change from Baseline at Day 1||-0.14|-0.64|0.0023
73824334|NCT05556148|147195072|OTHER||Mean Difference (Final Values)|-1.47|||<|0.0001|TWO_SIDED|95.0|-1.82|-1.12|||Student's paired t-test|||Change from Baseline at Day 2||-1.12|-1.82|<.0001
73824335|NCT05556148|147195072|OTHER||Mean Difference (Final Values)|-1.99|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.58|||Student's paired t-test|||Change from Baseline at Day 3||-1.58|-2.40|<.0001
73824336|NCT05556148|147195072|OTHER||Mean Difference (Final Values)|-2.43|||<|0.0001|TWO_SIDED|95.0|-2.86|-2.0|||Student's paired t-test|||Change from Baseline at Day 4||-2.00|-2.86|<.0001
73824337|NCT05556148|147195072|OTHER||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.51|-2.49|||Student's paired t-test|||Change from Baseline at Day 5||-2.49|-3.51|<.0001
73824338|NCT05556148|147195072|OTHER||Mean Difference (Final Values)|-2.77|||<|0.0001|TWO_SIDED|95.0|-3.36|-2.18|||Student's paired t-test|||Change from Baseline at Day 6||-2.18|-3.36|<.0001
73824339|NCT05556148|147195072|OTHER||Mean Difference (Final Values)|-3.33|||<|0.0001|TWO_SIDED|95.0|-4.1|-2.57|||Student's paired t-test|||Change from Baseline at Day 7||-2.57|-4.10|<.0001
73824340|NCT05556148|147195073|OTHER||Mean Difference (Final Values)|-0.11||||0.4495|TWO_SIDED|95.0|-0.4|0.18|||Student's paired t-test|||Change from Baseline at Day 1||0.18|-0.40|0.4495
73824341|NCT05556148|147195073|OTHER||Mean Difference (Final Values)|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.54|||Student's paired t-test|||Change from Baseline at Day 2||-0.54|-1.19|<.0001
73824342|NCT05556148|147195073|OTHER||Mean Difference (Final Values)|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.82|||Student's paired t-test|||Change from Baseline at Day 3||-0.82|-1.59|<.0001
73824343|NCT05556148|147195073|OTHER||Mean Difference (Final Values)|-1.59|||<|0.0001|TWO_SIDED|95.0|-2.05|-1.12|||Student's paired t-test|||Change from Baseline at Day 4||-1.12|-2.05|<.0001
73824344|NCT05556148|147195073|OTHER||Mean Difference (Final Values)|-1.86|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.33|||Student's paired t-test|||Change from Baseline at Day 5||-1.33|-2.40|<.0001
73824345|NCT05556148|147195073|OTHER||Mean Difference (Final Values)|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.45|-1.24|||Student's paired t-test|||Change from Baseline at Day 6||-1.24|-2.45|<.0001
73824346|NCT05556148|147195073|OTHER||Mean Difference (Final Values)|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.19|-1.75|||Student's paired t-test|||Change from Baseline at Day 7||-1.75|-3.19|<.0001
73824347|NCT05556148|147195074|OTHER||Mean Difference (Final Values)|0.11||||0.4758|TWO_SIDED|95.0|-0.2|0.42|||Student's paired t-test|||Change from Baseline at Day 1||0.42|-0.20|0.4758
73824348|NCT05556148|147195074|OTHER||Mean Difference (Final Values)|-0.61||||0.0016|TWO_SIDED|95.0|-0.99|-0.24|||Student's paired t-test|||Change from Baseline at Day 2||-0.24|-0.99|0.0016
73824349|NCT05556148|147195074|OTHER||Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.67|-0.79|||Student's paired t-test|||Change from Baseline at Day 3||-0.79|-1.67|<.0001
73824350|NCT05556148|147195074|OTHER||Mean Difference (Final Values)|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.18|-1.16|||Student's paired t-test|||Change from Baseline at Day 4||-1.16|-2.18|<.0001
73824351|NCT05556148|147195074|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.46|-1.51|||Student's paired t-test|||Change from Baseline at Day 5||-1.51|-2.46|<.0001
73824352|NCT05556148|147195074|OTHER||Mean Difference (Final Values)|-2.08|||<|0.0001|TWO_SIDED|95.0|-2.77|-1.39|||Student's paired t-test|||Change from Baseline at Day 6||-1.39|-2.77|<.0001
73824353|NCT05556148|147195074|OTHER||Mean Difference (Final Values)|-2.87|||<|0.0001|TWO_SIDED|95.0|-3.65|-2.08|||Student's paired t-test|||Change from Baseline at Day 7||-2.08|-3.65|<.0001
73824354|NCT05556148|147195075|OTHER||Mean Difference (Final Values)|-0.04||||0.8017|TWO_SIDED|95.0|-0.36|0.28|||Student's paired t-test|||Change from Baseline at Day 1||0.28|-0.36|0.8017
73824355|NCT05556148|147195075|OTHER||Mean Difference (Final Values)|-0.67||||0.0005|TWO_SIDED|95.0|-1.05|-0.3|||Student's paired t-test|||Change from Baseline at Day 2||-0.30|-1.05|0.0005
73824356|NCT05556148|147195075|OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.69|-0.89|||Student's paired t-test|||Change from Baseline at Day 3||-0.89|-1.69|<.0001
73824357|NCT05556148|147195075|OTHER||Mean Difference (Final Values)|-1.41|||<|0.0001|TWO_SIDED|95.0|-1.86|-0.97|||Student's paired t-test|||Change from Baseline at Day 4||-0.97|-1.86|<.0001
73824358|NCT05556148|147195075|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.47|||Student's paired t-test|||Change from Baseline at Day 5||-1.47|-2.50|<.0001
73824359|NCT05556148|147195075|OTHER||Mean Difference (Final Values)|-1.95|||<|0.0001|TWO_SIDED|95.0|-2.61|-1.29|||Student's paired t-test|||Change from Baseline at Day 6||-1.29|-2.61|<.0001
73824360|NCT05556148|147195075|OTHER||Mean Difference (Final Values)|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.26|-1.54|||Student's paired t-test|||Change from Baseline at Day 7||-1.54|-3.26|<.0001
73824361|NCT05556148|147195076|OTHER||Mean Difference (Final Values)|0.03||||0.8311|TWO_SIDED|95.0|-0.25|0.31|||Student's paired t-test|||Change from Baseline at Day 1||0.31|-0.25|0.8311
73824362|NCT05556148|147195076|OTHER||Mean Difference (Final Values)|-0.41||||0.0313|TWO_SIDED|95.0|-0.78|-0.04|||Student's paired t-test|||Change from Baseline at Day 2||-0.04|-0.78|0.0313
73824363|NCT05556148|147195076|OTHER||Mean Difference (Final Values)|-0.84||||0.0003|TWO_SIDED|95.0|-1.28|-0.39|||Student's paired t-test|||Change from Baseline at Day 3||-0.39|-1.28|0.0003
73824364|NCT05556148|147195076|OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.51|-0.59|||Student's paired t-test|||Change from Baseline at Day 4||-0.59|-1.51|<.0001
73824365|NCT05556148|147195076|OTHER||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.74|-0.66|||Student's paired t-test|||Change from Baseline at Day 5||-0.66|-1.74|<.0001
73824366|NCT05556148|147195076|OTHER||Mean Difference (Final Values)|-1.05||||0.0018|TWO_SIDED|95.0|-1.69|-0.42|||Student's paired t-test|||Change from Baseline at Day 6||-0.42|-1.69|0.0018
73824367|NCT05556148|147195076|OTHER||Mean Difference (Final Values)|-1.27||||0.0041|TWO_SIDED|95.0|-2.1|-0.43|||Student's paired t-test|||Change from Baseline at Day 7||-0.43|-2.10|0.0041
73824368|NCT05556148|147195077|OTHER||Mean Difference (Final Values)|0.01||||0.938|TWO_SIDED|95.0|-0.25|0.27|||Student's paired t-test|||Change from Baseline at Day 1||0.27|-0.25|0.9380
73824369|NCT05556148|147195077|OTHER||Mean Difference (Final Values)|-0.37||||0.0416|TWO_SIDED|95.0|-0.72|-0.01|||Student's paired t-test|||Change from Baseline at Day 2||-0.01|-0.72|0.0416
73824370|NCT05556148|147195077|OTHER||Mean Difference (Final Values)|-0.96|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.62|||Student's paired t-test|||Change from Baseline at Day 3||-0.62|-1.29|<.0001
73824371|NCT05556148|147195077|OTHER||Mean Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.76|||Student's paired t-test|||Change from Baseline at Day 4||-0.76|-1.60|<.0001
73824372|NCT05556148|147195077|OTHER||Mean Difference (Final Values)|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.27|||Student's paired t-test|||Change from Baseline at Day 5||-1.27|-2.25|<.0001
73824373|NCT05556148|147195077|OTHER||Mean Difference (Final Values)|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.05|||Student's paired t-test|||Change from Baseline at Day 6||-1.05|-2.33|<.0001
73824374|NCT05556148|147195077|OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.08|-1.52|||Student's paired t-test|||Change from Baseline at Day 7||-1.52|-3.08|<.0001
73824375|NCT05556148|147195078|OTHER||Mean Difference (Final Values)|0.04||||0.7821|TWO_SIDED|95.0|-0.25|0.33|||Student's paired t-test|||Change from Baseline at Day 1||0.33|-0.25|0.7821
73824376|NCT05556148|147195078|OTHER||Mean Difference (Final Values)|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.14|-0.39|||Student's paired t-test|||Change from Baseline at Day 2||-0.39|-1.14|<.0001
73824377|NCT05556148|147195078|OTHER||Mean Difference (Final Values)|-1.62|||<|0.0001|TWO_SIDED|95.0|-2.05|-1.19|||Student's paired t-test|||Change from Baseline at Day 3||-1.19|-2.05|<.0001
73824378|NCT05556148|147195078|OTHER||Mean Difference (Final Values)|-2.29|||<|0.0001|TWO_SIDED|95.0|-2.73|-1.86|||Student's paired t-test|||Change from Baseline at Day 4||-1.86|-2.73|<.0001
73824379|NCT05556148|147195078|OTHER||Mean Difference (Final Values)|-2.46|||<|0.0001|TWO_SIDED|95.0|-2.98|-1.94|||Student's paired t-test|||Change from Baseline at Day 5||-1.94|-2.98|<.0001
73824380|NCT05556148|147195078|OTHER||Mean Difference (Final Values)|-2.64|||<|0.0001|TWO_SIDED|95.0|-3.36|-1.92|||Student's paired t-test|||Change from Baseline at Day 6||-1.92|-3.36|<.0001
73824381|NCT05556148|147195078|OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.19|-2.21|||Student's paired t-test|||Change from Baseline at Day 7||-2.21|-4.19|<.0001
73824382|NCT05556148|147195079|OTHER||Mean Difference (Final Values)|0.44||||0.0003|TWO_SIDED|95.0|0.21|0.68|||Student's paired t-test|||Change from Baseline at Day 1||0.68|0.21|0.0003
73824383|NCT05556148|147195079|OTHER||Mean Difference (Final Values)|-0.07||||0.646|TWO_SIDED|95.0|-0.38|0.24|||Student's paired t-test|||Change from Baseline at Day 2||0.24|-0.38|0.6460
73824384|NCT05556148|147195079|OTHER||Mean Difference (Final Values)|-0.59||||0.0021|TWO_SIDED|95.0|-0.95|-0.22|||Student's paired t-test|||Change from Baseline at Day 3||-0.22|-0.95|0.0021
73824385|NCT05556148|147195079|OTHER||Mean Difference (Final Values)|-0.83||||0.0002|TWO_SIDED|95.0|-1.25|-0.41|||Student's paired t-test|||Change from Baseline at Day 4||-0.41|-1.25|0.0002
73824386|NCT05556148|147195079|OTHER||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.68|-0.73|||Student's paired t-test|||Change from Baseline at Day 5||-0.73|-1.68|<.0001
73824387|NCT05556148|147195079|OTHER||Mean Difference (Final Values)|-1.36||||0.0003|TWO_SIDED|95.0|-2.04|-0.68|||Student's paired t-test|||Change from Baseline at Day 6||-0.68|-2.04|0.0003
73824388|NCT05556148|147195079|OTHER||Mean Difference (Final Values)|-2.13|||<|0.0001|TWO_SIDED|95.0|-2.95|-1.32|||Student's paired t-test|||Change from Baseline at Day 7||-1.32|-2.95|<.0001
73824389|NCT05556148|147195080|OTHER||Mean Difference (Final Values)|0.2||||0.1074|TWO_SIDED|95.0|-0.04|0.45|||Student's paired t-test|||Change from Baseline at Day 1||0.45|-0.04|0.1074
73824390|NCT05556148|147195080|OTHER||Mean Difference (Final Values)|-0.35||||0.0364|TWO_SIDED|95.0|-0.67|-0.02|||Student's paired t-test|||Change from Baseline at Day 2||-0.02|-0.67|0.0364
73824391|NCT05556148|147195080|OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.68|-0.91|||Student's paired t-test|||Change from Baseline at Day 3||-0.91|-1.68|<.0001
73824392|NCT05556148|147195080|OTHER||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.36|||Student's paired t-test|||Change from Baseline at Day 4||-1.36|-2.25|<.0001
73824393|NCT05556148|147195080|OTHER||Mean Difference (Final Values)|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.78|-1.69|||Student's paired t-test|||Change from Baseline at Day 5||-1.69|-2.78|<.0001
73824394|NCT05556148|147195080|OTHER||Mean Difference (Final Values)|-2.08|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.45|||Student's paired t-test|||Change from Baseline at Day 6||-1.45|-2.70|<.0001
73824395|NCT05556148|147195080|OTHER||Mean Difference (Final Values)|-2.97|||<|0.0001|TWO_SIDED|95.0|-3.84|-2.1|||Student's paired t-test|||Change from Baseline at Day 7||-2.10|-3.84|<.0001
73824396|NCT05556148|147195081|OTHER||Mean Difference (Final Values)|-1.88|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.43|||Student's paired t-test|||Day 1||-1.43|-2.33|<.0001
73824397|NCT05556148|147195081|OTHER||Mean Difference (Final Values)|-2.45|||<|0.0001|TWO_SIDED|95.0|-2.9|-2.01|||Student's paired t-test|||Day 2||-2.01|-2.90|<.0001
73824398|NCT05556148|147195081|OTHER||Mean Difference (Final Values)|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.41|-2.39|||Student's paired t-test|||Day 3||-2.39|-3.41|<.0001
73824399|NCT05556148|147195081|OTHER||Mean Difference (Final Values)|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.82|-2.77|||Student's paired t-test|||Day 4||-2.77|-3.82|<.0001
73824400|NCT05556148|147195081|OTHER||Mean Difference (Final Values)|-2.95|||<|0.0001|TWO_SIDED|95.0|-3.53|-2.37|||Student's paired t-test|||Day 5||-2.37|-3.53|<.0001
73824401|NCT05556148|147195081|OTHER||Mean Difference (Final Values)|-3.26|||<|0.0001|TWO_SIDED|95.0|-3.98|-2.53|||Student's paired t-test|||Day 6||-2.53|-3.98|<.0001
73824402|NCT05556148|147195081|OTHER||Mean Difference (Final Values)|-3.12|||<|0.0001|TWO_SIDED|95.0|-4.08|-2.16|||Student's paired t-test|||Day 7||-2.16|-4.08|<.0001
73824403|NCT05556148|147195082|OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.14|-1.31|||Student's paired t-test|||Day 1||-1.31|-2.14|<.0001
73824404|NCT05556148|147195082|OTHER||Mean Difference (Final Values)|-2.12|||<|0.0001|TWO_SIDED|95.0|-2.55|-1.7|||Student's paired t-test|||Day 2||-1.70|-2.55|<.0001
73824405|NCT05556148|147195082|OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.9|||Student's paired t-test|||Day 3||-1.90|-2.71|<.0001
73824406|NCT05556148|147195082|OTHER||Mean Difference (Final Values)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.23|-2.29|||Student's paired t-test|||Day 4||-2.29|-3.23|<.0001
73824407|NCT05556148|147195082|OTHER||Mean Difference (Final Values)|-2.85|||<|0.0001|TWO_SIDED|95.0|-3.31|-2.39|||Student's paired t-test|||Day 5||-2.39|-3.31|<.0001
73824408|NCT05556148|147195082|OTHER||Mean Difference (Final Values)|-3.18|||<|0.0001|TWO_SIDED|95.0|-3.72|-2.64|||Student's paired t-test|||Day 6||-2.64|-3.72|<.0001
73824409|NCT05556148|147195082|OTHER||Mean Difference (Final Values)|-3.17|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.43|||Student's paired t-test|||Day 7||-2.43|-3.90|<.0001
73824410|NCT05556148|147195083|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.39|-1.57|||Student's paired t-test|||Day 1||-1.57|-2.39|<.0001
73824411|NCT05556148|147195083|OTHER||Mean Difference (Final Values)|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.81|||Student's paired t-test|||Day 2||-1.81|-2.66|<.0001
73824412|NCT05556148|147195083|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.14|-2.32|||Student's paired t-test|||Day 3||-2.32|-3.14|<.0001
73824413|NCT05556148|147195083|OTHER||Mean Difference (Final Values)|-2.91|||<|0.0001|TWO_SIDED|95.0|-3.4|-2.43|||Student's paired t-test|||Day 4||-2.43|-3.40|<.0001
73824414|NCT05556148|147195083|OTHER||Mean Difference (Final Values)|-3.17|||<|0.0001|TWO_SIDED|95.0|-3.68|-2.66|||Student's paired t-test|||Day 5||-2.66|-3.68|<.0001
73824415|NCT05556148|147195083|OTHER||Mean Difference (Final Values)|-3.28|||<|0.0001|TWO_SIDED|95.0|-4.02|-2.54|||Student's paired t-test|||Day 6||-2.54|-4.02|<.0001
73824416|NCT05556148|147195083|OTHER||Mean Difference (Final Values)|-3.47|||<|0.0001|TWO_SIDED|95.0|-4.24|-2.7|||Student's paired t-test|||Day 7||-2.70|-4.24|<.0001
73824417|NCT05556148|147195084|OTHER||Mean Difference (Final Values)|-1.96|||<|0.0001|TWO_SIDED|95.0|-2.37|-1.55|||Student's paired t-test|||Day 1||-1.55|-2.37|<.0001
73824418|NCT05556148|147195084|OTHER||Mean Difference (Final Values)|-2.42|||<|0.0001|TWO_SIDED|95.0|-2.83|-2.01|||Student's paired t-test|||Day 2||-2.01|-2.83|<.0001
73824419|NCT05556148|147195084|OTHER||Mean Difference (Final Values)|-2.97|||<|0.0001|TWO_SIDED|95.0|-3.41|-2.53|||Student's paired t-test|||Day 3||-2.53|-3.41|<.0001
73824420|NCT05556148|147195084|OTHER||Mean Difference (Final Values)|-3.34|||<|0.0001|TWO_SIDED|95.0|-3.81|-2.87|||Student's paired t-test|||Day 4||-2.87|-3.81|<.0001
73824421|NCT05556148|147195084|OTHER||Mean Difference (Final Values)|-3.36|||<|0.0001|TWO_SIDED|95.0|-3.84|-2.87|||Student's paired t-test|||Day 5||-2.87|-3.84|<.0001
73824422|NCT05556148|147195084|OTHER||Mean Difference (Final Values)|-3.23|||<|0.0001|TWO_SIDED|95.0|-3.91|-2.56|||Student's paired t-test|||Change from Baseline at Day 6||-2.56|-3.91|<.0001
73824423|NCT05556148|147195084|OTHER||Mean Difference (Final Values)|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.48|-2.92|||Student's paired t-test|||Day 7||-2.92|-4.48|<.0001
73824424|NCT05556148|147195085|OTHER||Mean Difference (Final Values)|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.17|-1.34|||Student's paired t-test|||Day 1||-1.34|-2.17|<.0001
73824425|NCT05556148|147195085|OTHER||Mean Difference (Final Values)|-2.09|||<|0.0001|TWO_SIDED|95.0|-2.51|-1.67|||Student's paired t-test|||Day 2||-1.67|-2.51|<.0001
73824426|NCT05556148|147195085|OTHER||Mean Difference (Final Values)|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.86|-1.97|||Student's paired t-test|||Day 3||-1.97|-2.86|<.0001
73824427|NCT05556148|147195085|OTHER||Mean Difference (Final Values)|-2.74|||<|0.0001|TWO_SIDED|95.0|-3.22|-2.27|||Student's paired t-test|||Day 4||-2.27|-3.22|<.0001
73824428|NCT05556148|147195085|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.3|-2.16|||Student's paired t-test|||Day 5||-2.16|-3.30|<.0001
73824429|NCT05556148|147195085|OTHER||Mean Difference (Final Values)|-2.87|||<|0.0001|TWO_SIDED|95.0|-3.56|-2.19|||Student's paired t-test|||Day 6||-2.19|-3.56|<.0001
73824430|NCT05556148|147195085|OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.01|-2.39|||Student's paired t-test|||Day 7||-2.39|-4.01|<.0001
73824431|NCT05556148|147195086|OTHER||Mean Difference (Final Values)|-1.93|||<|0.0001|TWO_SIDED|95.0|-2.35|-1.51|||Student's paired t-test|||Day 1||-1.51|-2.35|<.0001
73824432|NCT05556148|147195086|OTHER||Mean Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.0|-2.2|||Student's paired t-test|||Day 2||-2.20|-3.00|<.0001
73824433|NCT05556148|147195086|OTHER||Mean Difference (Final Values)|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.09|-2.22|||Student's paired t-test|||Day 3||-2.22|-3.09|<.0001
73824434|NCT05556148|147195086|OTHER||Mean Difference (Final Values)|-3.07|||<|0.0001|TWO_SIDED|95.0|-3.53|-2.62|||Student's paired t-test|||Day 4||-2.62|-3.53|<.0001
73824435|NCT05556148|147195086|OTHER||Mean Difference (Final Values)|-3.25|||<|0.0001|TWO_SIDED|95.0|-3.76|-2.75|||Student's paired t-test|||Day 5||-2.75|-3.76|<.0001
73824436|NCT05556148|147195086|OTHER||Mean Difference (Final Values)|-3.41|||<|0.0001|TWO_SIDED|95.0|-4.04|-2.78|||Student's paired t-test|||Day 6||-2.78|-4.04|<.0001
73824437|NCT05556148|147195086|OTHER||Mean Difference (Final Values)|-3.47|||<|0.0001|TWO_SIDED|95.0|-4.3|-2.64|||Student's paired t-test|||Day 7||-2.64|-4.30|<.0001
73824438|NCT05556148|147195087|OTHER||Mean Difference (Final Values)|-2.07|||<|0.0001|TWO_SIDED|95.0|-2.49|-1.66|||Student's paired t-test|||Day 1||-1.66|-2.49|<.0001
73824439|NCT05556148|147195087|OTHER||Mean Difference (Final Values)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.2|-2.33|||Student's paired t-test|||Day 2||-2.33|-3.20|<.0001
73824440|NCT05556148|147195087|OTHER||Mean Difference (Final Values)|-3.21|||<|0.0001|TWO_SIDED|95.0|-3.63|-2.78|||Student's paired t-test|||Day 3||-2.78|-3.63|<.0001
73824441|NCT05556148|147195087|OTHER||Mean Difference (Final Values)|-3.49|||<|0.0001|TWO_SIDED|95.0|-3.98|-3.0|||Student's paired t-test|||Day 4||-3.00|-3.98|<.0001
73824442|NCT05556148|147195087|OTHER||Mean Difference (Final Values)|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.33|-3.33|||Student's paired t-test|||Day 5||-3.33|-4.33|<.0001
73824443|NCT05556148|147195087|OTHER||Mean Difference (Final Values)|-4.05|||<|0.0001|TWO_SIDED|95.0|-4.65|-3.46|||Student's paired t-test|||Day 6||-3.46|-4.65|<.0001
73824444|NCT05556148|147195087|OTHER||Mean Difference (Final Values)|-4.13|||<|0.0001|TWO_SIDED|95.0|-4.81|-3.46|||Student's paired t-test|||Day 7||-3.46|-4.81|<.0001
73824445|NCT05556148|147195088|OTHER||Mean Difference (Final Values)|-2.21|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.77|||Student's paired t-test|||Day 1||-1.77|-2.66|<.0001
73824446|NCT05556148|147195088|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.15|-2.31|||Student's paired t-test|||Day 2||-2.31|-3.15|<.0001
73824447|NCT05556148|147195088|OTHER||Mean Difference (Final Values)|-3.16|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.73|||Student's paired t-test|||Day 3||-2.73|-3.60|<.0001
73824448|NCT05556148|147195088|OTHER||Mean Difference (Final Values)|-3.52|||<|0.0001|TWO_SIDED|95.0|-4.0|-3.05|||Student's paired t-test|||Day 4||-3.05|-4.00|<.0001
73824449|NCT05556148|147195088|OTHER||Mean Difference (Final Values)|-3.73|||<|0.0001|TWO_SIDED|95.0|-4.19|-3.27|||Student's paired t-test|||Day 5||-3.27|-4.19|<.0001
73824450|NCT05556148|147195088|OTHER||Mean Difference (Final Values)|-4.0|||<|0.0001|TWO_SIDED|95.0|-4.55|-3.45|||Student's paired t-test|||Day 6||-3.45|-4.55|<.0001
73824451|NCT05556148|147195088|OTHER||Mean Difference (Final Values)|-4.07|||<|0.0001|TWO_SIDED|95.0|-4.74|-3.39|||Student's paired t-test|||Day 7||-3.39|-4.74|<.0001
73824452|NCT00458003|147195089|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||.38
73824453|NCT00458003|147195090|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||.10
73824454|NCT00809445|147195091|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.52|||<|0.001|TWO_SIDED|97.5|3.57|5.72||a-prior threshold for statistical significance is .025|Cochran-Mantel-Haenszel||The numerator is the two HIV rapid testing arms The denominator is the HIV testing referral arm|Hypothesis: The HIV rapid testing arms would have a higher rate of HIV testing than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.||5.72|3.57|<0.001
73824455|NCT00809445|147195092|SUPERIORITY_OR_OTHER||incidence rate raios (IRR)|1.04||||0.39|TWO_SIDED|97.5|0.95|1.14||a-priori threshold for statistical significance is .025|generalized estimating equations (GEE)||Numerator includes the two HIV rapid testing groups Denominator is the HIV testing referral group|Hypothesis: The HIV rapid testing arms would have a lower rate of unprotected sexual episodes than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.||1.14|0.95|0.39
73824456|NCT00809445|147195092|SUPERIORITY_OR_OTHER||Incidence rate ratio (IRR)|1.03||||0.81|TWO_SIDED|97.5|0.84|1.26||a-priori threshold for statistical significance is .025|Generalized estimating equations (GEE)||Numerator is the HIV rapid test and counseling arm Denominator is the HIV rapid test and info arm|"The data analysis information presented is for the comparison of the 2 on-site testing groups.~Hypothesis: HIV rapid test and counseling group will have fewer unprotected sexual acts than will HIV rapid test and info group"||1.26|0.84|0.81
73824457|NCT00809445|147195093|SUPERIORITY_OR_OTHER|||||||0.044||||||a priori threshold for significance was .05|Chi-squared|Note that this is a 3 by 3 chi-square: the 3 conditions by discontinued sharing needles /no change in sharing needles/initiated sharing needles||||||0.044
73824458|NCT00809445|147195094|SUPERIORITY_OR_OTHER||||||<|0.0001||||||a-priori threshold for statistical significance is .05|Chi-squared|chi-square = 428.2466, Df=2||||||<0.0001
73824459|NCT01272908|147195114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.293||||0.253|||||||Regression, Logistic|||ACR20: Week 12 versus (vs) Week 4||||0.253
73824460|NCT01272908|147195114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.019||||0.005|||||||Regression, Logistic|||ACR20: Week 24 vs Week 4||||0.005
73824461|NCT01272908|147195114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.552||||0.023|||||||Regression, Logistic|||ACR50: Week 12 vs Week 4||||0.023
73824462|NCT01272908|147195114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.861||||0.001|||||||Regression, Logistic|||ACR50: Week 24 vs. Week 4||||0.001
73824463|NCT01272908|147195118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.099||||0.667|||||||Regression, Logistic|||Good vs Moderate vs None: Week 12 vs Week 4||||0.667
73824464|NCT01272908|147195118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.589|||<|0.001|||||||Regression, Logistic|||Good vs Moderate vs None: Week 24 vs Week 4||||<0.001
73824465|NCT01272908|147195118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.138||||0.44|||||||Regression, Logistic|||Good/Moderate vs None: Week 12 vs Week 4||||0.440
73824466|NCT01272908|147195118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.009||||0.012|||||||Regression, Logistic|||Good/Moderate vs None: Week 24 vs Week 4||||0.012
73824467|NCT01272908|147195120|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 4||||<0.001
73824468|NCT01272908|147195120|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 12||||<0.001
73824469|NCT01272908|147195120|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 24||||<0.001
73824470|NCT01272908|147195120|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 36||||<0.001
73824471|NCT01272908|147195120|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 48||||<0.001
73824472|NCT01272908|147195122|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed-Rank test|||Baseline vs Week 24||||<0.001
73824473|NCT01272908|147195124|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
73824474|NCT01272908|147195126|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
73824475|NCT01272908|147195128|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
73824476|NCT01272908|147195130|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
73824477|NCT01272908|147195132|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
73824478|NCT01272908|147195134|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
73824479|NCT01272908|147195136|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
73824480|NCT01272908|147195140|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 12||||<0.001
73824481|NCT01272908|147195140|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
73824482|NCT02131064|147195142|SUPERIORITY||Difference in tpCR rate|-11.71||||0.0126|TWO_SIDED|95.0|-20.95|-2.48||Threshold for significance at 5%|Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in tPCR rates between treatment arms was calculated using normal approximation.||-2.48|-20.95|0.0126
73824483|NCT02131064|147195143|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.7557|TWO_SIDED|95.0|0.37|3.96|||Cochran-Mantel-Haenszel Chi-Square Test|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||||3.96|0.37|0.7557
73824484|NCT02131064|147195144|SUPERIORITY||Difference in BCS rate|-10.84||||0.0228|TWO_SIDED|95.0|-20.21|-1.47|||Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in BCS rate between treatment arms was calculated using normal approximation.||-1.47|-20.21|0.0228
73824485|NCT02131064|147195145|SUPERIORITY||Hazard Ratio (HR)|2.61||||0.0027|TWO_SIDED|95.0|1.36|4.98|||Log Rank|The Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.||||4.98|1.36|0.0027
73824486|NCT02131064|147195146|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.52|2.4||||||||2.40|0.52|
73824487|NCT02131064|147195149|SUPERIORITY||Difference in Deterioration|-24.58|||||TWO_SIDED|95.0|-33.98|-15.19||||||95% CI for the difference in clinically meaningful deterioration in GHS/QoL score between treatment arms was calculated using normal approximation.||-15.19|-33.98|
73824488|NCT02131064|147195150|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0001|TWO_SIDED|95.0|0.46|0.78|||Log Rank|Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.||Stratified cox proportional hazards regression model was used to estimate Hazard Ratio and CI. Stratification by hormonal receptor status and clinical stage at presentation (stratification factors).||0.78|0.46|0.0001
73824489|NCT02131064|147195161|SUPERIORITY||Difference in Deterioration|-16.63|||||TWO_SIDED|95.0|-26.32|-6.94||||||This is the statistical analysis for cognitive functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-6.94|-26.32|
73824490|NCT02131064|147195161|SUPERIORITY||Difference in Deterioration|-32.54|||||TWO_SIDED|95.0|-41.74|-23.34||||||This is the statistical analysis for physical functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-23.34|-41.74|
73824491|NCT02131064|147195161|SUPERIORITY||Difference in Deterioration|-28.88|||||TWO_SIDED|95.0|-37.95|-19.8||||||This is the statistical analysis for role functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-19.80|-37.95|
73824492|NCT03143101|147195188|SUPERIORITY||Mean Difference (Net)|18.1||||0.006|TWO_SIDED|95.0|4.8|30.9||p-value is calculated from the Cochran-Mantel-Haenszel (CMH) test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel|||||30.9|4.8|0.006
73824493|NCT03143101|147195192|SUPERIORITY||Mean Difference (Net)|32.7|||<|0.001|TWO_SIDED|95.0|14.4|47.8||p-value is calculated from the CMH test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel|||||47.8|14.4|<0.001
73824494|NCT01630135|147195207|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.089|||<|0.001|TWO_SIDED|95.0|-1.41|-0.76|||ANCOVA||The analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for Treatment, Baseline, Age, and Sex.|||-0.76|-1.41|<0.001
73824495|NCT02554760|147195240|OTHER||success proportion|84.2|||||TWO_SIDED|95.0|60.4|92.3|||Catagorical tabulation|||||92.3|60.4|
73824496|NCT02554760|147195240|OTHER||success proportion|78.9|||||TWO_SIDED|95.0|54.4|93.9||||||||93.9|54.4|
73824497|NCT03243305|147195268|OTHER||Seven-cycle Pregnancy Percentage|13.65|||||TWO_SIDED|95.0|9.91|17.39|||Kaplan-Meier|||The primary hypothesis to be tested is whether subjects using Amphora vaginal gel have a 7-cycle cumulative pregnancy percentage less than or equal to 21%||17.39|9.91|
73824498|NCT02689804|147195270|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73824499|NCT02689804|147195271|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
73824500|NCT01569126|147195294|SUPERIORITY_OR_OTHER||Slope|0.026||||||95.0|||||||The correlation of time-matched change from baseline QTcF interval (dependent variable) to the time-matched plasma concentration of total fluoxetine and norfluoxetine (covariate) and participant (random effect).|||||
73824501|NCT01585246|147195300|OTHER||Maximum Tolerated Dose (MTD)|960.0|||||TWO_SIDED|||||||||The time-to-event continual reassessment method (TITE-CRM) was used The TITE-CRM incorporated a decision rule for the allocation of next participant to a dose of SP based on the current estimate of toxicity. The first men were allocated to lowest dose (320 mg); when no adverse event was reported during 12 weeks, the dose was increased to 640 mg for next men, and then to 960 mg in the absence of advert event.||||
73824502|NCT03110133|147195355|SUPERIORITY|||||||0.0488|||||||Chi-squared|||||||0.0488
73824503|NCT03110133|147195358|SUPERIORITY|||||||0.0347|||||||Chi-squared|||||||0.0347
73824504|NCT02155985|147195365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.7|TWO_SIDED|95.0|-5.5|8.8||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((300 mg mean fold change / placebo mean fold change) - 1) \* 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.||8.8|-5.5|0.70
73824505|NCT02155985|147195365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.5||||0.14|TWO_SIDED|95.0|-1.7|13.3||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((100 mg mean fold change / placebo mean fold change) - 1) \* 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.||13.3|-1.7|0.14
73824506|NCT02358031|147195428|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21211|TWO_SIDED|95.0|0.78|1.11||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro combo arm was compared to PFS in all participants of the control arm to address the sixth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.11|0.78|0.21211
73824507|NCT02358031|147195429|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.03697|TWO_SIDED|95.0|0.69|1.02||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the control arm to address the fifth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.02|0.69|0.03697
73824508|NCT02358031|147195430|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.02951|TWO_SIDED|95.0|0.58|1.01||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro combo arm was compared to PFS in CPS ≥20 participants of the control arm to address the fourth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||1.01|0.58|0.02951
73824509|NCT02358031|147195431|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00025|TWO_SIDED|95.0|0.6|0.87||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro combo arm was compared to OS in all participants of the control arm to address the fourteenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.87|0.60|0.00025
73824510|NCT02358031|147195432|SUPERIORITY||Hazard Ratio (HR)|0.65||||2e-05|TWO_SIDED|95.0|0.53|0.8||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the control arm to address the twelfth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.80|0.53|0.00002
73824511|NCT02358031|147195433|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.00044|TWO_SIDED|95.0|0.45|0.82||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro combo arm was compared to OS in CPS ≥20 participants of the control arm to address the eleventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||0.82|0.45|0.00044
73824512|NCT02358031|147195434|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.9983|TWO_SIDED|95.0|1.09|1.53||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro mono arm was compared to PFS in all participants of the control arm to address the third primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.53|1.09|0.99830
73824513|NCT02358031|147195435|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.8958|TWO_SIDED|95.0|0.94|1.36||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the control arm to address the second primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.36|0.94|0.89580
73824514|NCT02358031|147195436|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.46791|TWO_SIDED|95.0|0.76|1.29||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro mono arm was compared to PFS in CPS ≥20 participants of the control arm to address the first primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||1.29|0.76|0.46791
73824515|NCT02358031|147195437|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.01985|TWO_SIDED|95.0|0.7|0.99||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro mono arm was compared to OS in all participants of the control arm to address the tenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.99|0.70|0.01985
73824516|NCT02358031|147195438|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00133|TWO_SIDED|95.0|0.61|0.9||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the control arm to address the eighth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.90|0.61|0.00133
73824517|NCT02358031|147195439|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0001|TWO_SIDED|95.0|0.44|0.78||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro mono arm was compared to OS in CPS ≥20 participants of the control arm to address the seventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||0.78|0.44|0.00010
73824518|NCT02358031|147195446|OTHER||Difference in ORR Percentage|-0.8||||0.574|TWO_SIDED|95.0|-8.7|7.2||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro combo arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||7.2|-8.7|0.5740
73824519|NCT02358031|147195447|OTHER||Difference in ORR Percentage|0.5||||0.4586|TWO_SIDED|95.0|-8.2|9.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||9.1|-8.2|0.4586
73824520|NCT02358031|147195448|OTHER||Difference in ORR Percentage|5.0||||0.2161|TWO_SIDED|95.0|-7.5|17.4||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro combo arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).||17.4|-7.5|0.2161
73824521|NCT02358031|147195449|OTHER||Difference in LS Means|0.4||||0.839|TWO_SIDED|95.0|-3.46|4.26||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.||4.26|-3.46|0.839
73824522|NCT02358031|147195450|OTHER||Hazard Ratio (HR)|1.37||||0.9497|TWO_SIDED|95.0|0.94|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.00|0.94|0.9497
73824523|NCT02358031|147195451|OTHER||Hazard Ratio (HR)|1.37||||0.9476|TWO_SIDED|95.0|0.93|2.02||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Pain Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.02|0.93|0.9476
73824524|NCT02358031|147195452|OTHER||Hazard Ratio (HR)|1.05||||0.5836|TWO_SIDED|95.0|0.69|1.59||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Swallowing Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.59|0.69|0.5836
73824525|NCT02358031|147195459|OTHER||Difference in ORR Percentage|-19.0||||1|TWO_SIDED|95.0|-25.8|-12.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro mono arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive , Not Strongly Positive).||-12.1|-25.8|1.0000
73824526|NCT02358031|147195460|OTHER||Difference in ORR Percentage|-15.9||||1|TWO_SIDED|95.0|-23.4|-8.3||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||-8.3|-23.4|1.0000
73824527|NCT02358031|147195461|OTHER||Difference in ORR Percentage|-12.8||||0.9869|TWO_SIDED|95.0|-23.8|-1.5||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro mono arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).||-1.5|-23.8|0.9869
73824528|NCT02358031|147195462|OTHER||Difference in LS Means|0.24||||0.893|TWO_SIDED|95.0|-3.34|3.82||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.||3.82|-3.34|0.893
73824529|NCT02358031|147195463|OTHER||Hazard Ratio (HR)|1.38||||0.953|TWO_SIDED|95.0|0.95|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.00|0.95|0.9530
73824530|NCT02358031|147195464|OTHER||Hazard Ratio (HR)|0.8||||0.1501|TWO_SIDED|95.0|0.53|1.21||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Pain Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.21|0.53|0.1501
73824531|NCT02358031|147195465|OTHER||Hazard Ratio (HR)|1.26||||0.8751|TWO_SIDED|95.0|0.85|1.88||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Swallowing Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.88|0.85|0.8751
73824532|NCT01053741|147195496|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there is no difference in epithelial surface disruption when comparing the two interventions. Power calculation was based on identifying a median difference in histology grade of 0.83, using a two-sided alpha of 0.05 with 90% power in 10 subjects.||||<0.05
73824533|NCT03143257|147195498|SUPERIORITY||Mean Difference (Net)|38.0|STANDARD_DEVIATION|16.1|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73824534|NCT03143257|147195498|SUPERIORITY||Mean Difference (Net)|43.5|STANDARD_DEVIATION|20.0|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73824535|NCT03143257|147195498|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_DEVIATION|5.0|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
73824536|NCT03143257|147195501|SUPERIORITY||Overall Benefit Score|-15.0|STANDARD_DEVIATION|18.5|||TWO_SIDED||||||||The overall benefit can be determined by subtracting the aided and unaided scores of Ease of Communication, Reverberation, Background Noise \& Aversiveness. A negative score in overall benefit indicates a positive benefit to the subject.|||||
73824537|NCT00619827|147195502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.0003|TWO_SIDED|95.0|-2.99|-0.94|||ANCOVA|||||-0.94|-2.99|0.0003
73824538|NCT01063855|147195503|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|0.837|2.542||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|ANCOVA|ANCOVA model included treatment, PDE5I stratum, baseline Average IELT stratum, and region, as cofactors and baseline Average IELT as a covariate.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm minus PDE5I + Placebo arm difference.|Null Hypothesis: No difference at Week 12 last postbaseline observations carried forward (LPOCF) Alternative Hypothesis:- Difference at Week 12 LPOCF \>0.||2.542|0.837|<0.001
73824539|NCT01063855|147195504|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.6||||0.001|TWO_SIDED|95.0|4.9|22.3||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + placebo arm.|Null hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF). Alternative hypothesis: Difference at Week 12 LPOCF \> 0.||22.3|4.9|0.001
73824540|NCT01063855|147195505|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.2||||0.013|TWO_SIDED|95.0|1.1|17.2||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + Placebo arm.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF).||17.2|1.1|0.013
73824541|NCT01063855|147195506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.002|TWO_SIDED|95.0|1.204|2.619||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis: PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||2.619|1.204|0.002
73824542|NCT01063855|147195507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.007|TWO_SIDED|95.0|1.108|2.394||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carrried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||2.394|1.108|0.007
73824543|NCT01063855|147195508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.642|3.568||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.||3.568|1.642|<0.001
73824544|NCT01063855|147195509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|||>|0.05|TWO_SIDED|95.0|0.897|1.965||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||1.965|0.897|>0.05
73824545|NCT01063855|147195510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21|||<|0.001|TWO_SIDED|95.0|1.425|3.423||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.||3.423|1.425|<0.001
73824546|NCT02619617|147195540|OTHER|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|1.308||||0.698|TWO_SIDED|90.0|0.419|4.082|||Regression, Logistic|||||4.082|0.419|0.698
73824547|NCT02619617|147195541|OTHER|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|2.033||||0.385|TWO_SIDED|90.0|0.53|7.79|||Regression, Logistic|||||7.790|0.530|0.385
73824548|NCT01854697|147195544|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|14.7|||||TWO_SIDED|95.0|1.3|28.2|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.|||28.2|1.3|
73824549|NCT01854697|147195544|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.5|||||TWO_SIDED|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.6|6.4|
73824550|NCT01854697|147195545|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|2.28||0.351|TWO_SIDED|95.0|-2.39|6.65|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||6.65|-2.39|0.351
73824551|NCT01854697|147195545|SUPERIORITY_OR_OTHER||Least Squares Mean of Difference|5.83|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|2.19|9.47|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.47|2.19|0.002
73824552|NCT01854697|147195545|SUPERIORITY_OR_OTHER||Least Squares Mean of Difference|5.28|STANDARD_ERROR_OF_MEAN|1.65||0.002|TWO_SIDED|95.0|2.01|8.54|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||8.54|2.01|0.002
73824553|NCT01854697|147195546|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.08|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|2.72|9.44|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.44|2.72|<0.001
73824554|NCT01854697|147195546|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|1.34|<|0.001|TWO_SIDED|95.0|3.55|8.85|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||8.85|3.55|<0.001
73824555|NCT01854697|147195546|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.86|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|4.36|9.37|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.37|4.36|<0.001
73824556|NCT01854697|147195547|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.2||||0.021|TWO_SIDED|95.0|1.4|38.0|||Regression, Logistic|Logistic regression model with treatment arm, baseline log10 HCV RNA level, and interleukin 28B (IL28B) genotype (CC versus non-CC) as predictors.||||38.0|1.4|0.021
73824557|NCT01854697|147195547|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|20.8|||||TWO_SIDED|95.0|7.9|33.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||33.6|7.9|
73824558|NCT01854697|147195547|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.2||||0.002|TWO_SIDED|95.0|3.3|241.1|||Regression, Logistic|Calculated using logistic regression model with treatment arm, baseline log10 HCV RNA level, and IL28B genotype (CC versus non-CC) as predictors.||||241.1|3.3|0.002
73824559|NCT01854697|147195547|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratum-adjusted Cochran-Mantel-Haenszel after adjusting for IL28B genotype (CC or non-CC).||||||0.005
73824560|NCT01854697|147195550|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1a HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|13.3|||||TWO_SIDED|95.0|-0.4|27.0|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.|||27.0|-0.4|
73824561|NCT01854697|147195550|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.6|||||TWO_SIDED|95.0|6.5|32.7|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.7|6.5|
73824562|NCT01854697|147195550|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.5|||||TWO_SIDED|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.6|6.4|
73824563|NCT04428385|147195564|SUPERIORITY||Risk Ratio (RR)|0.85|||||TWO_SIDED|95.0|0.34|2.16||||||||2.16|0.34|
73824564|NCT04428385|147195565|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.47|1.78||||||||1.78|0.47|
73824565|NCT04428385|147195566|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.36|1.62||||||||1.62|0.36|
73824566|NCT04428385|147195567|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.33|1.33||||||||1.33|0.33|
73824567|NCT04428385|147195568|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.62|1.9||||||||1.90|0.62|
73824568|NCT03677635|147195617|OTHER||Standardised Effect Size|0.32|||||TWO_SIDED|95.0|0.21|0.86|||Standardised Effect Size|||||.86|.21|
73824569|NCT03677635|147195618|OTHER|Cohen's d was reported.|Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.59|0.48|||Standardised Effect Size|||||.48|-.59|
73824570|NCT02157519|147195633|SUPERIORITY||Odds Ratio (OR)|0.56||||0.186|TWO_SIDED|95.0|0.23|1.33||threshold p \<0.05|Regression, Logistic|Adjusted for baseline MMAS-4 scores (dichotomous) and change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of participants who self-reported adherence problems (i.e., dichotomous MMAS-4 scores) at post-assessment between groups adjusting for baseline self-reported adherence (i.e., dichotomous MMAS-4 scores) and change in perceived social support (MSPSS) from baseline to post-assessment.||1.33|0.23|0.186
73824571|NCT02157519|147195634|SUPERIORITY||Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|4.06||0.57|TWO_SIDED|95.0|-10.35|5.68||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the percentage of medication taken (as recorded by MEMS) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||5.68|-10.35|0.57
73824572|NCT02157519|147195635|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.21||0.603|TWO_SIDED|95.0|-0.31|0.53||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom severity (MDASI-severity) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.53|-0.31|0.603
73824573|NCT02157519|147195635|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.982|TWO_SIDED|95.0|-0.64|0.65||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom interference (MDASI-interference) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post assessment.||0.65|-0.64|0.982
73824574|NCT02157519|147195636|SUPERIORITY||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.65||0.144|TWO_SIDED|95.0|-5.66|0.83||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in overall QOL (FACT-G) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.83|-5.66|0.144
73824575|NCT02157519|147195636|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.66||0.294|TWO_SIDED|95.0|-2.0|0.61||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in physical QOL (FACT-Physical Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) baseline from baseline to post-assessment.||0.61|-2.00|0.294
73824576|NCT02157519|147195636|SUPERIORITY||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.74||0.025|TWO_SIDED|95.0|-3.12|-0.21||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in social QOL (FACT-Social Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||-0.21|-3.12|0.025
73824577|NCT02157519|147195636|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.58||0.392|TWO_SIDED|95.0|-0.64|1.63||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in emotional QOL (FACT-Emotional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||1.63|-0.64|0.392
73824578|NCT02157519|147195636|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.6||0.216|TWO_SIDED|95.0|-1.94|0.44||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in functional QOL (FACT-Functional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.44|-1.94|0.216
73824579|NCT02157519|147195637|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.28||0.17|TWO_SIDED|95.0|-0.93|0.17||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in treatment satisfaction with clinician explanations (FACIT-TS-PS-Clinician Explanations) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.17|-0.93|0.170
73824580|NCT02157519|147195637|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.057|TWO_SIDED|95.0|-0.72|0.01||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in satisfaction with interpersonal treatment (FACIT-TS-PS Interpersonal Treatment) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.01|-0.72|0.057
73824581|NCT02157519|147195637|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.72||0.178|TWO_SIDED|95.0|-2.39|0.45||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with comprehensive care (FACIT-TS-PS Comprehensive Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.45|-2.39|0.178
73824582|NCT02157519|147195637|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.481|TWO_SIDED|95.0|-0.35|0.75||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with nursing care (FACIT-TS-PS Nursing Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.75|-0.35|0.481
73824583|NCT02157519|147195637|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.97|TWO_SIDED|95.0|-0.34|0.35||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with trust in clinicians (FACIT-TS-PS Trust in Clinicians) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.35|-0.34|0.970
73824584|NCT02157519|147195638|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.682|TWO_SIDED|95.0|-0.15|0.1||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of emergency department (ED) visits over the study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.10|-0.15|0.682
73824585|NCT02157519|147195639|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.64|TWO_SIDED|95.0|-0.24|0.15||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of hospitalizations over they study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment||0.15|-0.24|0.640
73824586|NCT01656395|147195640|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.685|TWO_SIDED|95.0|-0.084|0.127|||cLDA model|||Difference in least squares (LS) means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 10 mg vs. Placebo. Constrained longitudinal data analysis (cLDA) model includes terms for visit as categorical variable, prior inhaled corticosteroid (ICS) use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.127|-0.084|0.685
73824587|NCT01656395|147195640|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.477|TWO_SIDED|95.0|-0.149|0.07|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.07|-0.149|0.477
73824588|NCT01656395|147195640|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.733|TWO_SIDED|95.0|-0.092|0.13|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.13|-0.092|0.733
73824589|NCT01656395|147195640|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.89|TWO_SIDED|95.0|-0.115|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.1|-0.115|0.89
73824590|NCT01656395|147195640|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.935|TWO_SIDED|95.0|-0.109|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.1|-0.109|0.935
73824591|NCT01656395|147195643|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.169|TWO_SIDED|95.0|-17.48|3.08|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 10 mg vs. Placebo. Analysis of variance (ANOVA) model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||3.08|-17.48|0.169
73824592|NCT01656395|147195643|SUPERIORITY||Mean Difference (Final Values)|-9.092||||0.092|TWO_SIDED|95.0|-19.67|1.485|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 30 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||1.485|-19.67|0.092
73824593|NCT01656395|147195643|SUPERIORITY||Mean Difference (Final Values)|-9.469||||0.083|TWO_SIDED|95.0|-20.19|1.25|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 60 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||1.25|-20.19|0.083
73824594|NCT01656395|147195643|SUPERIORITY||Mean Difference (Final Values)|-4.666||||0.367|TWO_SIDED|95.0|-14.83|5.501|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 150 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||5.501|-14.83|0.367
73824595|NCT01656395|147195643|SUPERIORITY||Mean Difference (Final Values)|-5.247||||0.308|TWO_SIDED|95.0|-15.36|4.871|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: Montelukast vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||4.871|-15.36|0.308
73824596|NCT01656395|147195644|SUPERIORITY||Mean Difference (Final Values)|-0.122||||0.429|TWO_SIDED|95.0|-0.427|0.182|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.182|-0.427|0.429
73824597|NCT01656395|147195644|SUPERIORITY||Mean Difference (Final Values)|0.142||||0.37|TWO_SIDED|95.0|-0.169|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.454|-0.169|0.370
73824598|NCT01656395|147195644|SUPERIORITY||Mean Difference (Final Values)|-0.089||||0.579|TWO_SIDED|95.0|-0.402|0.225|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.225|-0.402|0.579
73824599|NCT01656395|147195644|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.305|TWO_SIDED|95.0|-0.142|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.454|-0.142|0.305
73824600|NCT01656395|147195644|SUPERIORITY||Mean Difference (Final Values)|-0.136||||0.372|TWO_SIDED|95.0|-0.434|0.163|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.163|-0.434|0.372
73824601|NCT01656395|147195645|SUPERIORITY||Mean Difference (Final Values)|-0.528||||0.114|TWO_SIDED|95.0|-1.184|0.128|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use(Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.128|-1.184|0.114
73824602|NCT01656395|147195645|SUPERIORITY||Mean Difference (Final Values)|-0.075||||0.827|TWO_SIDED|95.0|-0.75|0.6|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.6|-0.75|0.827
73824603|NCT01656395|147195645|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.75|TWO_SIDED|95.0|-0.789|0.569|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.569|-0.789|0.75
73824604|NCT01656395|147195645|SUPERIORITY||Mean Difference (Final Values)|0.275||||0.403|TWO_SIDED|95.0|-0.371|0.921|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.921|-0.371|0.403
73824605|NCT01656395|147195645|SUPERIORITY||Mean Difference (Final Values)|-0.389||||0.237|TWO_SIDED|95.0|-1.035|0.257|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.257|-1.035|0.237
73824606|NCT01656395|147195646|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.565|TWO_SIDED|95.0|-1.066|0.583|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.583|-1.066|0.565
73824607|NCT01656395|147195646|SUPERIORITY||Mean Difference (Final Values)|0.135||||0.754|TWO_SIDED|95.0|-0.713|0.983|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.983|-0.713|0.754
73824608|NCT01656395|147195646|SUPERIORITY||cLDA model|-0.251||||0.563|TWO_SIDED|95.0|-1.104|0.603|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.603|-1.104|0.563
73824609|NCT01656395|147195646|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.559|TWO_SIDED|95.0|-1.053|0.571|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.571|-1.053|0.559
73824610|NCT01656395|147195646|SUPERIORITY||Mean Difference (Final Values)|-0.071||||0.863|TWO_SIDED|95.0|-0.883|0.741|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.741|-0.883|0.863
73824611|NCT01656395|147195647|SUPERIORITY||Mean Difference (Final Values)|0.544||||0.958|TWO_SIDED|95.0|-19.92|21.007|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||21.007|-19.92|0.958
73824612|NCT01656395|147195647|SUPERIORITY||Mean Difference (Final Values)|6.251||||0.559|TWO_SIDED|95.0|-14.81|27.307|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK- 1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||27.307|-14.81|0.559
73824613|NCT01656395|147195647|SUPERIORITY||Median Difference (Final Values)|9.575||||0.374|TWO_SIDED|95.0|-11.62|30.766|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||30.766|-11.62|0.374
73824614|NCT01656395|147195647|SUPERIORITY||Mean Difference (Final Values)|5.114||||0.618|TWO_SIDED|95.0|-15.04|25.272|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||25.272|-15.04|0.618
73824615|NCT01656395|147195647|SUPERIORITY||Mean Difference (Final Values)|-1.604||||0.876|TWO_SIDED|95.0|-21.76|18.554|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||18.554|-21.76|0.876
73824616|NCT01656395|147195648|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.682|TWO_SIDED|95.0|-0.288|0.44|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.440|-0.288|0.682
73824617|NCT01656395|147195648|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.807|TWO_SIDED|95.0|-0.422|0.329|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.329|-0.422|0.807
73824618|NCT01656395|147195648|SUPERIORITY||Mean Difference (Final Values)|0.165||||0.403|TWO_SIDED|95.0|-0.222|0.552|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.552|-0.222|0.403
73824619|NCT01656395|147195648|SUPERIORITY||Mean Difference (Final Values)|0.375||||0.051|TWO_SIDED|95.0|-0.001|0.751|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.751|-0.001|0.051
73824620|NCT01656395|147195648|SUPERIORITY||Mean Difference (Final Values)|0.319||||0.086|TWO_SIDED|95.0|-0.045|0.683|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.683|-0.045|0.086
73824621|NCT01656395|147195649|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.7687|TWO_SIDED|95.0|-16.0|21.3|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% confidence intervals (CIs) are based on the Miettinen and Nurminen (MN) method stratified by prior ICS use (Yes/No).||21.3|-16.0|0.7687
73824622|NCT01656395|147195649|SUPERIORITY||Mean Difference (Final Values)|-6.6||||0.4943|TWO_SIDED|95.0|-24.9|12.2|||MN Method|||Difference for AQLQ(S) Response Rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||12.2|-24.9|0.4943
73824623|NCT01656395|147195649|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.3003|TWO_SIDED|95.0|-9.4|29.6|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||29.6|-9.4|0.3003
73824624|NCT01656395|147195649|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.0774|TWO_SIDED|95.0|-1.9|35.7|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||35.7|-1.9|0.0774
73824625|NCT01656395|147195649|SUPERIORITY||Mean Difference (Final Values)|18.2||||0.0555|TWO_SIDED|95.0|-0.4|35.5|||MN method|||Difference for AQLQ(S) Response Rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||35.5|-0.4|0.0555
73824626|NCT01656395|147195650|SUPERIORITY||Mean Difference (Final Values)|-0.104||||0.603|TWO_SIDED|95.0|-0.495|0.288|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.288|-0.495|0.603
73824627|NCT01656395|147195650|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.875|TWO_SIDED|95.0|-0.436|0.372|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.372|-0.436|0.875
73824628|NCT01656395|147195650|SUPERIORITY||Mean Difference (Final Values)|-0.151||||0.476|TWO_SIDED|95.0|-0.568|0.265|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.265|-0.568|0.476
73824629|NCT01656395|147195650|SUPERIORITY||Mean Difference (Final Values)|-0.362||||0.079|TWO_SIDED|95.0|-0.767|0.042|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.042|-0.767|0.079
73824630|NCT01656395|147195650|SUPERIORITY||Mean Difference (Final Values)|-0.227||||0.257|TWO_SIDED|95.0|-0.621|0.166|||cLDA model|||"Difference in LS means for change from Baseline to Week 12 in ACQ Score: Montelukast vs. Placebo.~cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast)."||0.166|-0.621|0.257
73824631|NCT01656395|147195651|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.742|TWO_SIDED|95.0|-15.1|21.1|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||21.1|-15.1|0.742
73824632|NCT01656395|147195651|SUPERIORITY||Mean Difference (Final Values)|-3.4||||0.7248|TWO_SIDED|95.0|-22.1|15.4|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||15.4|-22.1|0.7248
73824633|NCT01656395|147195651|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.6991|TWO_SIDED|95.0|-15.6|22.6|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||22.6|-15.6|0.6991
73824634|NCT01656395|147195651|SUPERIORITY||Mean Difference (Final Values)|8.1||||0.3934|TWO_SIDED|95.0|-10.6|26.2|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||26.2|-10.6|0.3934
73824635|NCT01656395|147195651|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.8032|TWO_SIDED|95.0|-16.0|20.5|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||20.5|-16.0|0.8032
73824636|NCT01656395|147195652|SUPERIORITY||Mean Difference (Final Values)|-0.075||||0.873|TWO_SIDED|95.0|-1.004|0.853|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 10 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.853|-1.004|0.873
73824637|NCT01656395|147195652|SUPERIORITY||Mean Difference (Final Values)|-0.376||||0.437|TWO_SIDED|95.0|-1.326|0.575|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 30 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.575|-1.326|0.437
73824638|NCT01656395|147195652|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.27|TWO_SIDED|95.0|-1.504|0.423|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 60 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.423|-1.504|0.270
73824639|NCT01656395|147195652|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.865|TWO_SIDED|95.0|-0.839|0.997|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 150 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.997|-0.839|0.865
73824640|NCT01656395|147195652|SUPERIORITY||Mean Difference (Final Values)|-0.309||||0.503|TWO_SIDED|95.0|-1.219|0.6|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: Montelukast vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.600|-1.219|0.503
73824641|NCT00676403|147195700|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|37.3||||||95.0|0.1|157.7|||ED-50: Bootstrap Method||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED50 distribution or confidence interval.|Dose response analysis ED 50: dose providing 50% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.||157.7|0.1|
73824642|NCT00676403|147195700|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|123.9||||||95.0|0.4|523.9|||ED 90: Bootstrap Method||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED90 distribution or confidence interval.|Dose response analysis ED 90: dose providing 90% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.||523.9|0.4|
73824643|NCT00676403|147195700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.472||0.0983||95.0|-8.97|0.77|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.77|-8.97|0.0983
73824644|NCT00676403|147195700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.03|STANDARD_ERROR_OF_MEAN|2.415||0.0966||95.0|-8.78|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.73|-8.78|0.0966
73824645|NCT00676403|147195700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.29|STANDARD_ERROR_OF_MEAN|2.548||0.0013||95.0|-13.31|-3.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.28|-13.31|0.0013
73824646|NCT00676403|147195700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.16|STANDARD_ERROR_OF_MEAN|2.437||0.0353||95.0|-9.96|-0.36|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.36|-9.96|0.0353
73824647|NCT00676403|147195700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.53|STANDARD_ERROR_OF_MEAN|2.469||0.0006||95.0|-13.4|-3.67|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.67|-13.40|0.0006
73824648|NCT00676403|147195701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8784||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8784
73824649|NCT00676403|147195701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6767||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6767
73824650|NCT00676403|147195701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8955||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8955
73824651|NCT00676403|147195701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9505||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9505
73824652|NCT00676403|147195701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0466
73824653|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3876||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3876
73824654|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7959||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.7959
73824655|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2032||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.2032
73824656|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7032||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.7032
73824657|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0551||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0551
73824658|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.4100
73824659|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6524||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6524
73824660|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3219||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3219
73824661|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3509||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3509
73824662|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0053||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0053
73824663|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9835||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9835
73824664|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6668||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6668
73824665|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2823||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.2823
73824666|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5687||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.5687
73824667|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0043||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0043
73824668|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8662||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8662
73824669|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3656||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3656
73824670|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0806||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0806
73824671|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5381||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.5381
73824672|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0090
73824673|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9748||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9748
73824674|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3936||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3936
73824675|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1563||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.1563
73824676|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6357||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6357
73824677|NCT00676403|147195702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0133
73824678|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6|STANDARD_ERROR_OF_MEAN|8.05||0.4133||95.0|-22.4|9.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.3|-22.4|0.4133
73824679|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|7.92||0.6676||95.0|-19.0|12.2|||Mixed Models Analysis|||Week 1: Conrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.2|-19.0|0.6676
73824680|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|8.04||0.9355||95.0|-16.5|15.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.2|-16.5|0.9355
73824681|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|7.97||0.9355||95.0|-15.1|16.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.4|-15.1|0.9355
73824682|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|7.94||0.1895||95.0|-26.1|5.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-26.1|0.1895
73824683|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.9|STANDARD_ERROR_OF_MEAN|8.1||0.1443||95.0|-27.8|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-27.8|0.1443
73824684|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.4|STANDARD_ERROR_OF_MEAN|7.96||0.2946||95.0|-24.0|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-24.0|0.2946
73824685|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.4|STANDARD_ERROR_OF_MEAN|8.22||0.3686||95.0|-23.6|8.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.8|-23.6|0.3686
73824686|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|8.02||0.6079||95.0|-19.9|11.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.7|-19.9|0.6079
73824687|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.5|STANDARD_ERROR_OF_MEAN|7.99||0.0016||95.0|-41.2|-9.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-9.7|-41.2|0.0016
73824688|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|8.22||0.5976||95.0|-20.5|11.8|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.8|-20.5|0.5976
73824689|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|8.0||0.8527||95.0|-14.3|17.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.3|-14.3|0.8527
73824690|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.29||0.6973||95.0|-19.6|13.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.1|-19.6|0.6973
73824691|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.09||0.6895||95.0|-19.2|12.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.7|-19.2|0.6895
73824692|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.1|STANDARD_ERROR_OF_MEAN|8.21||0.0209||95.0|-35.2|-2.9|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.9|-35.2|0.0209
73824693|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|8.18||0.4084||95.0|-22.9|9.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.3|-22.9|0.4084
73824694|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|7.96||0.3958||95.0|-22.5|8.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.9|-22.5|0.3958
73824695|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|8.25||0.5776||95.0|-20.9|11.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.7|-20.9|0.5776
73824696|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|8.06||0.5665||95.0|-20.5|11.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.3|-20.5|0.5665
73824697|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.5|STANDARD_ERROR_OF_MEAN|8.13||0.0041||95.0|-39.6|-7.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-7.5|-39.6|0.0041
73824698|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|STANDARD_ERROR_OF_MEAN|8.22||0.1842||95.0|-27.1|5.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-27.1|0.1842
73824699|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|8.0||0.8269||95.0|-17.5|14.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.0|-17.5|0.8269
73824700|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|8.34||0.3319||95.0|-24.5|8.3|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.3|-24.5|0.3319
73824701|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|8.09||0.7552||95.0|-13.4|18.5|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.5|-13.4|0.7552
73824702|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.3|STANDARD_ERROR_OF_MEAN|8.16||0.0137||95.0|-36.3|-4.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-4.2|-36.3|0.0137
73824703|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.0|STANDARD_ERROR_OF_MEAN|8.22||0.1157||95.0|-29.2|3.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.2|-29.2|0.1157
73824704|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.04||0.3791||95.0|-22.9|8.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.7|-22.9|0.3791
73824705|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.7|STANDARD_ERROR_OF_MEAN|8.39||0.1329||95.0|-29.2|3.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.9|-29.2|0.1329
73824706|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|8.09||0.7723||95.0|-13.6|18.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.3|-13.6|0.7723
73824707|NCT00676403|147195703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.5|STANDARD_ERROR_OF_MEAN|8.16||0.0063||95.0|-38.6|-6.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-6.4|-38.6|0.0063
73824708|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.254||0.1715||95.0|-0.15|0.85|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.85|-0.15|0.1715
73824709|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.251||0.7944||95.0|-0.43|0.56|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.56|-0.43|0.7944
73824710|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.255||0.1994||95.0|-0.17|0.83|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.83|-0.17|0.1994
73824711|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.251||0.3652||95.0|-0.27|0.72|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.72|-0.27|0.3652
73824712|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.251||0.0481||95.0|0.0|0.99|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.99|0.00|0.0481
73824713|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.256||0.2501||95.0|-0.21|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.80|-0.21|0.2501
73824714|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.252||0.5191||95.0|-0.33|0.66|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.66|-0.33|0.5191
73824715|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.262||0.0817||95.0|-0.06|0.97|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.97|-0.06|0.0817
73824716|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.253||0.1146||95.0|-0.1|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.90|-0.10|0.1146
73824717|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.253||0.0054||95.0|0.21|1.21|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.21|0.21|0.0054
73824718|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.261||0.3389||95.0|-0.26|0.76|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.76|-0.26|0.3389
73824719|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.254||0.5079||95.0|-0.33|0.67|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.67|-0.33|0.5079
73824720|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.265||0.0453||95.0|0.01|1.05|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.05|0.01|0.0453
73824721|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.256||0.1622||95.0|-0.15|0.86|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.86|-0.15|0.1622
73824722|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.262||0.0003||95.0|0.45|1.48|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.48|0.45|0.0003
73824723|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.26||0.0383||95.0|0.03|1.05|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.05|0.03|0.0383
73824724|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.253||0.4495||95.0|-0.31|0.69|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.69|-0.31|0.4495
73824725|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.263||0.0135||95.0|0.14|1.17|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0135
73824726|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.254||0.1423||95.0|-0.13|0.87|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.87|-0.13|0.1423
73824727|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.259||0.0035||95.0|0.25|1.27|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.27|0.25|0.0035
73824728|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.261||0.0125||95.0|0.14|1.17|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0125
73824729|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.254||0.8021||95.0|-0.44|0.56|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.56|-0.44|0.8021
73824730|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.267||0.0249||95.0|0.08|1.13|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.13|0.08|0.0249
73824731|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.256||0.3383||95.0|-0.26|0.75|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.75|-0.26|0.3383
73824732|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|0.26||0.0001||95.0|0.55|1.57|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.57|0.55|0.0001
73824733|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.261||0.0133||95.0|0.14|1.17|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0133
73824734|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.256||0.382||95.0|-0.28|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.73|-0.28|0.3820
73824735|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.269||0.0053||95.0|0.23|1.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.28|0.23|0.0053
73824736|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.256||0.3258||95.0|-0.25|0.76|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.76|-0.25|0.3258
73824737|NCT00676403|147195704|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.0005||95.0|0.41|1.43|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.43|0.41|0.0005
73824738|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1429||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.0|0.1429
73824739|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0547||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.2|0.0547
73824740|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.0095||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.2|-1.4|0.0095
73824741|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3676||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3676
73824742|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2959||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.2959
73824743|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3435||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3435
73824744|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0895||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.0895
73824745|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0844||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.0844
73824746|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0675||95.0|-1.1|0.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.1|0.0675
73824747|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.225||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-1.0|0.2250
73824748|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3728||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3728
73824749|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2686||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.2686
73824750|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0753||95.0|-1.2|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.2|0.0753
73824751|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1335||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.0|0.1335
73824752|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.31||0.022||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-1.3|0.0220
73824753|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.5754||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.5754
73824754|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.348||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3480
73824755|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0554||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.2|0.0554
73824756|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4362||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.4362
73824757|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3631||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3631
73824758|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.1152||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.1152
73824759|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4741||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.4741
73824760|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.31||0.0091||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.2|-1.4|0.0091
73824761|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1721||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-1.0|0.1721
73824762|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.31||0.0262||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-1.3|0.0262
73824763|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.31||0.9505||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.6|-0.6|0.9505
73824764|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6877||95.0|-0.7|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.5|-0.7|0.6877
73824765|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.1271||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.1271
73824766|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9136||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.6|-0.6|0.9136
73824767|NCT00676403|147195705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.4072||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.4072
73824768|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|10.68||0.186||95.0|-35.2|6.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.9|-35.2|0.1860
73824769|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|10.54||0.653||95.0|-25.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.0|-25.5|0.6530
73824770|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|10.79||0.6263||95.0|-26.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.0|-26.5|0.6263
73824771|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|STANDARD_ERROR_OF_MEAN|10.63||0.4266||95.0|-29.4|12.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.5|-29.4|0.4266
73824772|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|10.54||0.4023||95.0|-29.6|11.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.9|-29.6|0.4023
73824773|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|10.77||0.1041||95.0|-38.8|3.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.6|-38.8|0.1041
73824774|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|10.6||0.5084||95.0|-27.9|13.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.8|-27.9|0.5084
73824775|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|11.1||0.262||95.0|-34.3|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.4|-34.3|0.2620
73824776|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|10.7||0.3347||95.0|-31.4|10.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.7|-31.4|0.3347
73824777|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|10.61||0.1142||95.0|-37.7|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-37.7|0.1142
73824778|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|11.06||0.1237||95.0|-38.8|4.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-38.8|0.1237
73824779|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|10.67||0.8302||95.0|-18.7|23.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.3|-18.7|0.8302
73824780|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|11.22||0.3039||95.0|-33.6|10.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.5|-33.6|0.3039
73824781|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|10.77||0.4595||95.0|-29.2|13.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.2|-29.2|0.4595
73824782|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|10.97||0.4338||95.0|-30.2|13.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.0|-30.2|0.4338
73824783|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|10.99||0.0647||95.0|-42.0|1.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-42.0|0.0647
73824784|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|10.61||0.5651||95.0|-27.0|14.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.8|-27.0|0.5651
73824785|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.6|STANDARD_ERROR_OF_MEAN|11.16||0.1634||95.0|-37.6|6.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.4|-37.6|0.1634
73824786|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.2|STANDARD_ERROR_OF_MEAN|10.77||0.2209||95.0|-34.4|8.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.0|-34.4|0.2209
73824787|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5|STANDARD_ERROR_OF_MEAN|10.84||0.1293||95.0|-37.8|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-37.8|0.1293
73824788|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.8|STANDARD_ERROR_OF_MEAN|11.06||0.0161||95.0|-48.5|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-5.0|-48.5|0.0161
73824789|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|10.67||0.8506||95.0|-23.0|19.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.0|-23.0|0.8506
73824790|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-30.9|STANDARD_ERROR_OF_MEAN|11.31||0.0067||95.0|-53.2|-8.6|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-8.6|-53.2|0.0067
73824791|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|10.76||0.1997||95.0|-35.0|7.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-35.0|0.1997
73824792|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.4|STANDARD_ERROR_OF_MEAN|10.9||0.0159||95.0|-47.9|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-5.0|-47.9|0.0159
73824793|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.8|STANDARD_ERROR_OF_MEAN|10.98||0.0388||95.0|-44.4|-1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.2|-44.4|0.0388
73824794|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|10.73||0.9962||95.0|-21.2|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-21.2|0.9962
73824795|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.8|STANDARD_ERROR_OF_MEAN|11.41||0.0839||95.0|-42.3|2.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.7|-42.3|0.0839
73824796|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|10.83||0.5216||95.0|-28.3|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-28.3|0.5216
73824797|NCT00676403|147195706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.3|STANDARD_ERROR_OF_MEAN|10.98||0.0534||95.0|-42.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-42.9|0.0534
73824798|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|5.89||0.0199||95.0|2.2|25.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.4|2.2|0.0199
73824799|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|5.78||0.0768||95.0|-1.1|21.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.7|-1.1|0.0768
73824800|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.91||0.0642||95.0|-0.7|22.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.6|-0.7|0.0642
73824801|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|5.88||0.2643||95.0|-5.0|18.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.2|-5.0|0.2643
73824802|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.2|STANDARD_ERROR_OF_MEAN|5.8||0.0358||95.0|0.8|23.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.7|0.8|0.0358
73824803|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|5.93||0.0428||95.0|0.4|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.8|0.4|0.0428
73824804|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.5|STANDARD_ERROR_OF_MEAN|5.81||0.1993||95.0|-4.0|18.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.9|-4.0|0.1993
73824805|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.9|STANDARD_ERROR_OF_MEAN|6.04||0.0331||95.0|1.1|24.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.8|1.1|0.0331
73824806|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|5.91||0.0415||95.0|0.5|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.8|0.5|0.0415
73824807|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.8|STANDARD_ERROR_OF_MEAN|5.83||0.0295||95.0|1.3|24.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.3|1.3|0.0295
73824808|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|6.01||0.1267||95.0|-2.6|21.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-2.6|0.1267
73824809|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|5.84||0.4175||95.0|-6.8|16.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.2|-6.8|0.4175
73824810|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0|STANDARD_ERROR_OF_MEAN|6.09||0.0342||95.0|1.0|25.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.0|1.0|0.0342
73824811|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7|STANDARD_ERROR_OF_MEAN|5.96||0.1038||95.0|-2.0|21.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.5|-2.0|0.1038
73824812|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.6|STANDARD_ERROR_OF_MEAN|5.98||0.0537||95.0|-0.2|23.4|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.4|-0.2|0.0537
73824813|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|5.99||0.0772||95.0|-1.2|22.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.4|-1.2|0.0772
73824814|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|5.81||0.1296||95.0|-2.6|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.3|-2.6|0.1296
73824815|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.0|STANDARD_ERROR_OF_MEAN|6.06||0.014||95.0|3.1|27.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||27.0|3.1|0.0140
73824816|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.93||0.0642||95.0|-0.7|22.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.7|-0.7|0.0642
73824817|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|5.92||0.073||95.0|-1.0|22.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.3|-1.0|0.0730
73824818|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|6.01||0.0215||95.0|2.1|25.8|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.8|2.1|0.0215
73896535|NCT03456882|147326404|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.25||0.8133|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.8133
73824819|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.84||0.3785||95.0|-6.4|16.7|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.7|-6.4|0.3785
73824820|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|6.12||0.0089||95.0|4.1|28.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.2|4.1|0.0089
73824821|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.2|STANDARD_ERROR_OF_MEAN|5.96||0.0609||95.0|-0.5|23.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.0|-0.5|0.0609
73824822|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|5.95||0.0064||95.0|4.7|28.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.1|4.7|0.0064
73824823|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.7|STANDARD_ERROR_OF_MEAN|6.01||0.0241||95.0|1.8|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.5|1.8|0.0241
73824824|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.6|STANDARD_ERROR_OF_MEAN|5.86||0.1032||95.0|-2.0|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-2.0|0.1032
73824825|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.6|STANDARD_ERROR_OF_MEAN|6.16||0.0076||95.0|4.4|28.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.7|4.4|0.0076
73824826|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|5.96||0.1257||95.0|-2.6|20.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.9|-2.6|0.1257
73824827|NCT00676403|147195707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|5.95||0.0131||95.0|3.2|26.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.6|3.2|0.0131
73824828|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|6.94||0.1824||95.0|-23.0|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-23.0|0.1824
73824829|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.8||0.0767||95.0|-25.5|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-25.5|0.0767
73824830|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|7.11||0.0492||95.0|-28.1|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-28.1|0.0492
73824831|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.7|STANDARD_ERROR_OF_MEAN|6.84||0.2023||95.0|-22.2|4.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-22.2|0.2023
73896536|NCT03456882|147326405|SUPERIORITY|||||||0.5239||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.5239
73824832|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.4|STANDARD_ERROR_OF_MEAN|6.83||0.0116||95.0|-30.9|-3.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.9|-30.9|0.0116
73824833|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|7.01||0.1819||95.0|-23.2|4.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-23.2|0.1819
73824834|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|6.76||0.2806||95.0|-20.6|6.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.0|-20.6|0.2806
73824835|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|7.13||0.1465||95.0|-24.4|3.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.7|-24.4|0.1465
73824836|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.6|STANDARD_ERROR_OF_MEAN|6.85||0.0046||95.0|-33.1|-6.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-6.1|-33.1|0.0046
73824837|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|6.92||0.0187||95.0|-30.0|-2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.8|-30.0|0.0187
73824838|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|7.0||0.6128||95.0|-10.2|17.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.3|-10.2|0.6128
73824839|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|6.76||0.3488||95.0|-19.7|7.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.0|-19.7|0.3488
73824840|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|7.17||0.1472||95.0|-24.5|3.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.7|-24.5|0.1472
73824841|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|6.89||0.0791||95.0|-25.7|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.4|-25.7|0.0791
73824842|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.4|STANDARD_ERROR_OF_MEAN|6.97||0.0282||95.0|-29.1|-1.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.7|-29.1|0.0282
73824843|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|7.08||0.1623||95.0|-23.9|4.0|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.0|-23.9|0.1623
73824844|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|6.84||0.3739||95.0|-19.6|7.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-19.6|0.3739
73824845|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|7.26||0.0517||95.0|-28.5|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-28.5|0.0517
73824846|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.92||0.0815||95.0|-25.8|1.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.5|-25.8|0.0815
73824847|NCT00676403|147195708|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|7.0||0.0031||95.0|-34.7|-7.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-7.1|-34.7|0.0031
73824848|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|7.88||0.3368||95.0|-8.0|23.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.1|-8.0|0.3368
73824849|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.2|STANDARD_ERROR_OF_MEAN|7.75||0.4232||95.0|-21.5|9.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.1|-21.5|0.4232
73824850|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|8.09||0.7082||95.0|-12.9|19.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.0|-12.9|0.7082
73824851|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|7.7||0.9466||95.0|-15.7|14.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.7|-15.7|0.9466
73824852|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|7.72||0.3746||95.0|-22.1|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-22.1|0.3746
73824853|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|7.95||0.9336||95.0|-15.0|16.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.3|-15.0|0.9336
73824854|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|7.71||0.2029||95.0|-25.0|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.4|-25.0|0.2029
73824855|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.18||0.3833||95.0|-23.3|9.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.0|-23.3|0.3833
73824856|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|7.72||0.8152||95.0|-17.0|13.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.4|-17.0|0.8152
73824857|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|7.81||0.1739||95.0|-26.1|4.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-26.1|0.1739
73824858|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|7.94||0.3392||95.0|-8.0|23.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.3|-8.0|0.3392
73824859|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|7.71||0.913||95.0|-16.0|14.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-16.0|0.9130
73824860|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|8.22||0.6||95.0|-20.5|11.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.9|-20.5|0.6000
73824861|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|STANDARD_ERROR_OF_MEAN|7.75||0.4445||95.0|-9.3|21.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.2|-9.3|0.4445
73824862|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|7.85||0.9656||95.0|-15.8|15.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.1|-15.8|0.9656
73824863|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|8.02||0.5679||95.0|-11.2|20.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.4|-11.2|0.5679
73824864|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|7.79||0.5619||95.0|-19.9|10.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.8|-19.9|0.5619
73824865|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|8.31||0.993||95.0|-16.3|16.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.4|-16.3|0.9930
73824866|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|7.79||0.6892||95.0|-12.2|18.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.5|-12.2|0.6892
73824867|NCT00676403|147195709|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|7.89||0.4928||95.0|-21.0|10.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.1|-21.0|0.4928
73824868|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.6|STANDARD_ERROR_OF_MEAN|5.1||0.2719||95.0|-4.4|15.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.6|-4.4|0.2719
73824869|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|5.02||0.693||95.0|-7.9|11.8|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.8|-7.9|0.6930
73824870|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|5.24||0.7178||95.0|-12.2|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-12.2|0.7178
73824871|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|4.96||0.8037||95.0|-11.0|8.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.5|-11.0|0.8037
73824872|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|5.02||0.0832||95.0|-1.2|18.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.6|-1.2|0.0832
73824873|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|5.17||0.3554||95.0|-5.4|14.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.9|-5.4|0.3554
73824874|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|4.96||0.9538||95.0|-9.5|10.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.0|-9.5|0.9538
73824875|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|5.26||0.5593||95.0|-13.4|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.4|0.5593
73824876|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|4.97||0.8663||95.0|-8.9|10.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.6|-8.9|0.8663
73824877|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|5.12||0.119||95.0|-2.1|18.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.1|-2.1|0.1190
73824878|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|5.15||0.1544||95.0|-2.8|17.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.5|-2.8|0.1544
73824879|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|4.97||0.8439||95.0|-8.8|10.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.7|-8.8|0.8439
73824880|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|5.3||0.9925||95.0|-10.5|10.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.4|-10.5|0.9925
73824881|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|5.02||0.8784||95.0|-9.1|10.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.6|-9.1|0.8784
73824882|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|5.17||0.8948||95.0|-9.5|10.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.8|-9.5|0.8948
73824883|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|5.26||0.2197||95.0|-3.9|16.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.8|-3.9|0.2197
73824884|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|5.07||0.6183||95.0|-7.4|12.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.5|-7.4|0.6183
73824885|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|5.42||0.4484||95.0|-14.8|6.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.5|-14.8|0.4484
73824886|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4|STANDARD_ERROR_OF_MEAN|5.07||0.3857||95.0|-5.6|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-5.6|0.3857
73824887|NCT00676403|147195710|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.22||0.8824||95.0|-11.0|9.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.5|-11.0|0.8824
73824888|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.9|STANDARD_ERROR_OF_MEAN|7.87||0.1673||95.0|-4.6|26.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.4|-4.6|0.1673
73824889|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|7.71||0.9839||95.0|-15.0|15.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.3|-15.0|0.9839
73824890|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|8.06||0.2905||95.0|-7.3|24.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.4|-7.3|0.2905
73824891|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|7.69||0.5513||95.0|-10.6|19.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.7|-10.6|0.5513
73824892|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|7.77||0.1589||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-4.3|0.1589
73824893|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4|STANDARD_ERROR_OF_MEAN|7.95||0.0541||95.0|-0.3|31.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||31.0|-0.3|0.0541
73824894|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|7.66||0.5987||95.0|-11.0|19.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.1|-11.0|0.5987
73824895|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|8.1||0.4372||95.0|-9.6|22.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.2|-9.6|0.4372
73824896|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|7.71||0.8336||95.0|-16.8|13.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.6|-16.8|0.8336
73824897|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|7.9||0.0804||95.0|-1.7|29.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||29.4|-1.7|0.0804
73824898|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.3|STANDARD_ERROR_OF_MEAN|7.94||0.2985||95.0|-7.4|23.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.9|-7.4|0.2985
73824899|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|7.66||0.4991||95.0|-9.9|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.3|-9.9|0.4991
73824900|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|STANDARD_ERROR_OF_MEAN|8.15||0.2675||95.0|-7.0|25.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.1|-7.0|0.2675
73824901|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|7.77||0.1593||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-4.3|0.1593
73824902|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.9|STANDARD_ERROR_OF_MEAN|7.96||0.0179||95.0|3.3|34.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||34.6|3.3|0.0179
73824903|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|8.06||0.0281||95.0|1.9|33.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||33.7|1.9|0.0281
73824904|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|7.77||0.1883||95.0|-5.0|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.5|-5.0|0.1883
73824905|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|8.28||0.23||95.0|-6.3|26.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-6.3|0.2300
73824906|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|7.82||0.7575||95.0|-13.0|17.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.8|-13.0|0.7575
73824907|NCT00676403|147195711|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.3|STANDARD_ERROR_OF_MEAN|8.02||0.0757||95.0|-1.5|30.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||30.1|-1.5|0.0757
73824908|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.89||0.2817||95.0|-18.0|5.2|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-18.0|0.2817
73824909|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|5.76||0.6796||95.0|-13.7|9.0|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.0|-13.7|0.6796
73824910|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|6.01||0.2505||95.0|-18.8|4.9|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.9|-18.8|0.2505
73824911|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|5.73||0.5102||95.0|-15.1|7.5|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.5|-15.1|0.5102
73824912|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.78||0.5706||95.0|-14.7|8.1|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.1|-14.7|0.5706
73824913|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|5.95||0.4708||95.0|-16.0|7.4|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-16.0|0.4708
73824914|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|5.72||0.6202||95.0|-8.4|14.1|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.1|-8.4|0.6202
73824915|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|6.04||0.4177||95.0|-16.8|7.0|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.0|-16.8|0.4177
73824916|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|5.75||0.6509||95.0|-8.7|13.9|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.9|-8.7|0.6509
73824917|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|5.86||0.8273||95.0|-10.3|12.8|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.8|-10.3|0.8273
73824918|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.94||0.2842||95.0|-18.1|5.3|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.3|-18.1|0.2842
73824919|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|5.72||0.7041||95.0|-9.1|13.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.5|-9.1|0.7041
73824920|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|6.07||0.7216||95.0|-14.1|9.8|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-14.1|0.7216
73824921|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|5.78||0.6188||95.0|-14.3|8.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.5|-14.3|0.6188
73824922|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|5.9||0.8096||95.0|-10.2|13.0|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.0|-10.2|0.8096
73824923|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6|STANDARD_ERROR_OF_MEAN|6.01||0.0157||95.0|-26.5|-2.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.8|-26.5|0.0157
73824924|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|5.79||0.6007||95.0|-14.4|8.4|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-14.4|0.6007
73824925|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|6.15||0.1057||95.0|-22.1|2.1|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.1|-22.1|0.1057
73824926|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|5.81||0.7764||95.0|-13.1|9.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-13.1|0.7764
73824927|NCT00676403|147195712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|5.93||0.7146||95.0|-13.9|9.5|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.5|-13.9|0.7146
73824928|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.2978||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.2978
73824929|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7242||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7242
73824930|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.32||0.0773||95.0|-0.1|1.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.1|0.0773
73824931|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7831||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7831
73824932|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3291||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.3291
73824933|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3692||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.3692
73824934|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7614||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7614
73824935|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0355||95.0|0.0|1.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|0.0|0.0355
73824936|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5068||95.0|-0.4|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.8|-0.4|0.5068
73824937|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0561||95.0|0.0|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.0|0.0561
73824938|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.31||0.2223||95.0|-0.2|1.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.0|-0.2|0.2223
73824939|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6791||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.6791
73824940|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.32||0.0188||95.0|0.1|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.4|0.1|0.0188
73824941|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1314||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.1|-0.1|0.1314
73824942|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.31||0.09||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.1|-0.1|0.0900
73824943|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.4144||95.0|-0.4|0.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.4|0.4144
73824944|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7699||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7699
73824945|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0406||95.0|0.0|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|0.0|0.0406
73824946|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7574||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7574
73824947|NCT00676403|147195713|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0554||95.0|0.0|1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.0|0.0554
73824948|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.36||0.5409||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.8|0.5409
73824949|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|5.25||0.823||95.0|-11.5|9.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.2|-11.5|0.8230
73824950|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|5.48||0.2958||95.0|-16.5|5.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-16.5|0.2958
73824951|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|5.27||0.3708||95.0|-15.1|5.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.7|-15.1|0.3708
73824952|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|5.27||0.1853||95.0|-17.4|3.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.4|-17.4|0.1853
73824953|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|5.41||0.1834||95.0|-17.9|3.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.4|-17.9|0.1834
73824954|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.22||0.8711||95.0|-11.1|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.4|-11.1|0.8711
73824955|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|5.5||0.3252||95.0|-16.3|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.4|-16.3|0.3252
73824956|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|5.28||0.3205||95.0|-15.7|5.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-15.7|0.3205
73824957|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|5.34||0.0837||95.0|-19.8|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-19.8|0.0837
73824958|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.4||0.8895||95.0|-11.4|9.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.9|-11.4|0.8895
73824959|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|5.22||0.6469||95.0|-12.7|7.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.9|-12.7|0.6469
73824960|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|5.53||0.2687||95.0|-17.0|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-17.0|0.2687
73824961|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|5.31||0.1757||95.0|-17.7|3.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.3|-17.7|0.1757
73824962|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.7|STANDARD_ERROR_OF_MEAN|5.38||0.0306||95.0|-22.3|-1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.1|-22.3|0.0306
73824963|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|5.47||0.0857||95.0|-20.2|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-20.2|0.0857
73824964|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|5.28||0.2932||95.0|-16.0|4.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-16.0|0.2932
73824965|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|5.6||0.0613||95.0|-21.6|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.5|-21.6|0.0613
73824966|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.34||0.5431||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.8|0.5431
73824967|NCT00676403|147195714|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|5.41||0.0262||95.0|-22.7|-1.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.4|-22.7|0.0262
73824968|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|5.44||0.1547||95.0|-18.5|3.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.0|-18.5|0.1547
73824969|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|5.33||0.2532||95.0|-16.6|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-16.6|0.2532
73824970|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|5.56||0.0848||95.0|-20.6|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-20.6|0.0848
73824971|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|5.36||0.2424||95.0|-16.8|4.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.3|-16.8|0.2424
73824972|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|5.35||0.047||95.0|-21.2|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-21.2|0.0470
73824973|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|5.49||0.1494||95.0|-18.8|2.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.9|-18.8|0.1494
73824974|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|5.3||0.5081||95.0|-13.9|6.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.9|-13.9|0.5081
73824975|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|5.58||0.2141||95.0|-17.9|4.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.0|-17.9|0.2141
73824976|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|5.37||0.1484||95.0|-18.4|2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.8|-18.4|0.1484
73824977|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|5.42||0.0963||95.0|-19.7|1.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.6|-19.7|0.0963
73824978|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|5.48||0.8519||95.0|-11.8|9.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-11.8|0.8519
73824979|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|5.3||0.477||95.0|-14.2|6.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.7|-14.2|0.4770
73824980|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|5.61||0.2166||95.0|-18.0|4.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-18.0|0.2166
73824981|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|5.4||0.1062||95.0|-19.4|1.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.9|-19.4|0.1062
73824982|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|STANDARD_ERROR_OF_MEAN|5.45||0.0475||95.0|-21.6|-0.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-21.6|0.0475
73824983|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|5.54||0.0537||95.0|-21.7|0.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-21.7|0.0537
73824984|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|5.35||0.3153||95.0|-15.9|5.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-15.9|0.3153
73824985|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|5.68||0.0424||95.0|-22.8|-0.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.4|-22.8|0.0424
73824986|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|5.42||0.3077||95.0|-16.2|5.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-16.2|0.3077
73824987|NCT00676403|147195715|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.6|STANDARD_ERROR_OF_MEAN|5.48||0.0224||95.0|-23.4|-1.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.8|-23.4|0.0224
73824988|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.7|STANDARD_ERROR_OF_MEAN|2.65||0.0646||95.0|0.9|15.0|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.0|0.9|0.0646
73824989|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2|STANDARD_ERROR_OF_MEAN|1.58||0.2947||95.0|0.5|9.1|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||9.1|0.5|0.2947
73824990|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.6|STANDARD_ERROR_OF_MEAN|3.1||0.0249||95.0|1.2|17.2|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||17.2|1.2|0.0249
73824991|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.99||0.7671||95.0|0.3|5.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||5.9|0.3|0.7671
73824992|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.6|STANDARD_ERROR_OF_MEAN|2.9||0.0169||95.0|1.3|15.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.9|1.3|0.0169
73824993|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.74||0.9569||95.0|0.2|4.3|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.3|0.2|0.9569
73824994|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2|STANDARD_ERROR_OF_MEAN|2.07||0.0711||95.0|0.9|11.4|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means.Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||11.4|0.9|0.0711
73824995|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8|STANDARD_ERROR_OF_MEAN|1.85||0.1073||95.0|0.8|10.2|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||10.2|0.8|0.1073
73824996|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.4|STANDARD_ERROR_OF_MEAN|1.48||0.1583||95.0|0.7|8.1|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||8.1|0.7|0.1583
73824997|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|STANDARD_ERROR_OF_MEAN|2.8||0.0385||95.0|1.1|15.6|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.6|1.1|0.0385
73824998|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|STANDARD_ERROR_OF_MEAN|1.09||0.4923||95.0|0.4|6.1|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.1|0.4|0.4923
73824999|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.8||0.7169||95.0|0.4|4.4|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.4|0.4|0.7169
73825000|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.12||0.4156||95.0|0.5|6.2|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.2|0.5|0.4156
73825001|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.04||0.4165||95.0|0.5|5.6|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||5.6|0.5|0.4165
73825002|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|STANDARD_ERROR_OF_MEAN|1.08||0.4673||95.0|0.4|6.0|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.0|0.4|0.4673
73825003|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.72||0.9855||95.0|0.2|4.1|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.1|0.2|0.9855
73825004|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.61||0.9566||95.0|0.3|3.3|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||3.3|0.3|0.9566
73825005|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.17||0.4632||95.0|0.4|6.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.6|0.4|0.4632
73825006|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.29||0.2042||95.0|0.1|1.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||1.6|0.1|0.2042
73825007|NCT00676403|147195716|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9|STANDARD_ERROR_OF_MEAN|1.34||0.3382||95.0|0.5|7.5|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||7.5|0.5|0.3382
73825008|NCT00676403|147195717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6||||0.3932||95.0|-6.0|15.2|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||15.2|-6.0|0.3932
73825009|NCT00676403|147195717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3||||0.1585||95.0|-2.9|17.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||17.5|-2.9|0.1585
73825010|NCT00676403|147195717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.285||95.0|-4.9|16.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||16.5|-4.9|0.2850
73825011|NCT00676403|147195717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.8645||95.0|-9.4|11.1|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||11.1|-9.4|0.8645
73825012|NCT00676403|147195717|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4||||0.3031||95.0|-5.0|15.8|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||15.8|-5.0|0.3031
73825013|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.5384||95.0|-13.2|7.0|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.0|-13.2|0.5384
73825014|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.8015||95.0|-10.9|8.5|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.5|-10.9|0.8015
73825015|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1||||0.4429||95.0|-14.5|6.4|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||6.4|-14.5|0.4429
73825016|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.886||95.0|-10.5|9.1|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.1|-10.5|0.8860
73825017|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9963||95.0|-10.0|9.9|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.9|-10.0|0.9963
73825018|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9||||0.3421||95.0|-6.3|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.1|-6.3|0.3421
73825019|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.4||||0.2849||95.0|-5.4|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.1|-5.4|0.2849
73825020|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.6||||0.3058||95.0|-6.1|19.2|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.2|-6.1|0.3058
73825021|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.9604||95.0|-12.1|11.5|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.5|-12.1|0.9604
73825022|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5||||0.1661||95.0|-3.6|20.6|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.6|-3.6|0.1661
73825023|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.9||||0.1441||95.0|-3.1|20.9|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.9|-3.1|0.1441
73825024|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0||||0.3076||95.0|-5.6|17.5|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.5|-5.6|0.3076
73825025|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0||||0.1209||95.0|-2.7|22.7|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||22.7|-2.7|0.1209
73825026|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.4||||0.2791||95.0|-5.3|18.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.0|-5.3|0.2791
73825027|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.2||||0.0644||95.0|-0.7|23.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||23.0|-0.7|0.0644
73825028|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.7544||95.0|-9.5|6.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||6.9|-9.5|0.7544
73825029|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.6||||0.5142||95.0|-10.3|5.2|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||5.2|-10.3|0.5142
73825030|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.8158||95.0|-7.4|9.4|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.4|-7.4|0.8158
73825031|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9||||0.4599||95.0|-10.8|4.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||4.9|-10.8|0.4599
73825032|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.8636||95.0|-8.7|7.3|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.3|-8.7|0.8636
73825033|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7||||0.5281||95.0|-7.8|15.1|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.1|-7.8|0.5281
73825034|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.6566||95.0|-8.5|13.5|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||13.5|-8.5|0.6566
73825035|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.1||||0.0677||95.0|-0.8|23.0|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||23.0|-0.8|0.0677
73825036|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.3||||0.4443||95.0|-6.8|15.4|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.4|-6.8|0.4443
73825037|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5||||0.2543||95.0|-4.7|17.7|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.7|-4.7|0.2543
73825038|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.9416||95.0|-11.0|11.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.9|-11.0|0.9416
73825039|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.5824||95.0|-14.1|7.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.9|-14.1|0.5824
73825040|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4||||0.5668||95.0|-15.3|8.4|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.4|-15.3|0.5668
73825041|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.7769||95.0|-9.6|12.8|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.8|-9.6|0.7769
73825042|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.1753||95.0|-3.5|19.1|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.1|-3.5|0.1753
73825043|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.7||||0.1508||95.0|-3.2|20.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.7|-3.2|0.1508
73825044|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.9||||0.0916||95.0|-1.6|21.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||21.4|-1.6|0.0916
73825045|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1||||0.6222||95.0|-9.2|15.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.4|-9.2|0.6222
73825046|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.2||||0.085||95.0|-1.4|21.8|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||21.8|-1.4|0.0850
73825047|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.8||||0.0154||95.0|2.9|26.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||26.7|2.9|0.0154
73825048|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.7201||95.0|-11.9|8.2|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.2|-11.9|0.7201
73825049|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.8875||95.0|-9.1|10.5|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.5|-9.1|0.8875
73825050|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7||||0.3735||95.0|-5.7|15.1|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.1|-5.7|0.3735
73825051|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.8621||95.0|-8.9|10.6|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.6|-8.9|0.8621
73825052|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.9||||0.1203||95.0|-2.1|17.8|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.8|-2.1|0.1203
73825053|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.4966||95.0|-5.4|11.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.0|-5.4|0.4966
73825054|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2||||0.5776||95.0|-5.6|10.1|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.1|-5.6|0.5776
73825055|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7||||0.3955||95.0|-4.9|12.3|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.3|-4.9|0.3955
73825056|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.7994||95.0|-6.9|9.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.0|-6.9|0.7994
73825057|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2||||0.2073||95.0|-2.9|13.2|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||13.2|-2.9|0.2073
73825058|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2||||0.5148||95.0|-6.4|12.8|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.8|-6.4|0.5148
73825059|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.5255||95.0|-6.3|12.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.2|-6.3|0.5255
73825060|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4||||0.3793||95.0|-5.5|14.4|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||14.4|-5.5|0.3793
73825061|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.8||||0.312||95.0|-4.5|14.1|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||14.1|-4.5|0.3120
73825062|NCT00676403|147195718|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7||||0.0442||95.0|0.3|19.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.2|0.3|0.0442
73825063|NCT00676403|147195719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4452||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4452
73825064|NCT00676403|147195719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4342||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4342
73825065|NCT00676403|147195719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0942||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.0942
73825066|NCT00676403|147195719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1873||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.1873
73825067|NCT00676403|147195719|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4709
73825068|NCT01039467|147195724|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73825069|NCT01039467|147195725|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73825070|NCT01039467|147195726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.833||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.833
73825071|NCT01039467|147195727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.265||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.265
73825072|NCT01039467|147195728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
73825073|NCT01039467|147195729|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
73825074|NCT01039467|147195730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0008
73825075|NCT01039467|147195731|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.053
73825076|NCT01039467|147195732|SUPERIORITY_OR_OTHER_LEGACY|||||||0.493||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.493
73825077|NCT01746862|147195733|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|3.47|||<|0.0001|TWO_SIDED|95.0|2.17|4.78|||ANCOVA|Analysis was performed using analysis of covariance (ANCOVA) with baseline age and baseline height as the covariates.||||4.78|2.17|<0.0001
73825078|NCT06058390|147195773|OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.91|1.14|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.14|0.91|
73825079|NCT06058390|147195774|OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.96|1.15|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.15|0.96|
73825080|NCT06058390|147195775|OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.88|1.18|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.18|0.88|
73825081|NCT06058390|147195776|OTHER||Geometric mean ratio|0.98|||||TWO_SIDED|90.0|0.88|1.09|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.09|0.88|
73825082|NCT06058390|147195777|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.87|1.13|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.13|0.87|
73825083|NCT06058390|147195778|OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.87|1.08|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.08|0.87|
73825084|NCT03361306|147195779|SUPERIORITY|Assuming the true VGPR+ rate is 40% under the null hypothesis, then this design will provide 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. For the originally planned enrollment of 40 subjects, if at least 21 subjects achieved VGPR or better to induction, the null hypothesis would be rejected.|Response Rate|0.467||||0.39|TWO_SIDED|95.0|0.213|0.734||This p-value is only based on partial enrollment on the study. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|||0.734|0.213|0.390
73825085|NCT04073303|147195786|SUPERIORITY||Rate-Difference|49.0|||<|0.0001|TWO_SIDED|95.0|40.1|54.1|||Cochran-Mantel-Haenszel|||||54.1|40.1|<0.0001
73825086|NCT04073303|147195787|SUPERIORITY||Rate-Difference|71.2|||<|0.0001|TWO_SIDED|95.0|60.7|76.3|||Cochran-Mantel-Haenszel|||||76.3|60.7|<0.0001
73825087|NCT04073303|147195788|SUPERIORITY||Rate-Difference|56.7|||<|0.0001|TWO_SIDED|95.0|45.6|64.5|||Cochran-Mantel-Haenszel|||||64.5|45.6|<0.0001
73825088|NCT04073303|147195789|SUPERIORITY||Rate-Difference|49.7|||<|0.0001|TWO_SIDED|95.0|40.6|57.4|||Cochran-Mantel-Haenszel|||||57.4|40.6|<0.0001
73825089|NCT04073303|147195790|SUPERIORITY||Rate-Difference|70.5|||<|0.0001|TWO_SIDED|95.0|59.6|77.5|||Cochran-Mantel-Haenszel|||||77.5|59.6|<0.0001
73825090|NCT04073303|147195791|SUPERIORITY||LS Mean of Difference|-5.19|||<|0.0001|TWO_SIDED|95.0|-5.64|-4.75|||ANCOVA|||||-4.75|-5.64|<0.0001
73825091|NCT00810069|147195874|SUPERIORITY_OR_OTHER|||||||0.213|TWO_SIDED|95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier Analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Kaplan-Meier Estimates (weeks): analysis of early intervention versus delayed intervention strategies||||0.213
73825092|NCT00810069|147195875|SUPERIORITY_OR_OTHER||survival rate difference|0.02||||0.653|TWO_SIDED|95.0|-0.06|0.1||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies||0.10|-0.06|0.653
73825093|NCT00810069|147195876|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Analysis of early intervention strategy versus delayed intervention strategy||||0.947
73825094|NCT00810069|147195877|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||P-value is for early intervention versus delayed intervention strategies.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Analysis of early intervention strategy versus delayed intervention strategy||||0.597
73825095|NCT00810069|147195878|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.624|TWO_SIDED|95.0|-0.22|0.13||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6||0.13|-0.22|0.624
73825096|NCT00810069|147195878|SUPERIORITY_OR_OTHER||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.208|TWO_SIDED|95.0|-0.29|0.06||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed Models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||0.06|-0.29|0.208
73825097|NCT00810069|147195878|SUPERIORITY_OR_OTHER||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.09||0.044|TWO_SIDED|95.0|-0.37|0.0||P-value for Week 10: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10||-0.00|-0.37|0.044
73825098|NCT00810069|147195878|SUPERIORITY_OR_OTHER||LS Mean|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.086|TWO_SIDED|95.0|-0.35|0.02||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interactions, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.02|-0.35|0.086
73825099|NCT00810069|147195878|SUPERIORITY_OR_OTHER||LS Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.181|TWO_SIDED|95.0|-0.33|0.06||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14||0.06|-0.33|0.181
73825100|NCT00810069|147195878|SUPERIORITY_OR_OTHER||LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.994|TWO_SIDED|95.0|-0.2|0.2||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.20|-0.20|0.994
73825101|NCT00810069|147195879|SUPERIORITY_OR_OTHER||LS Mean|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-0.98|-0.25||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6||-0.25|-0.98|0.001
73825102|NCT00810069|147195879|SUPERIORITY_OR_OTHER||LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|95.0|-0.87|-0.12||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||-0.12|-0.87|0.010
73825103|NCT00810069|147195879|SUPERIORITY_OR_OTHER||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.445|TWO_SIDED|95.0|-0.55|0.24||P-value for Week 10: analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10||0.24|-0.55|0.445
73825104|NCT00810069|147195879|SUPERIORITY_OR_OTHER||LS Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.21||0.169|TWO_SIDED|95.0|-0.71|0.12||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.12|-0.71|0.169
73825105|NCT00810069|147195879|SUPERIORITY_OR_OTHER||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.23||0.393|TWO_SIDED|95.0|-0.63|0.25||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14||0.25|-0.63|0.393
73825106|NCT00810069|147195879|SUPERIORITY_OR_OTHER||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.51|TWO_SIDED|95.0|-0.61|0.3||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline scores and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.30|-0.61|0.510
73825107|NCT00810069|147195880|SUPERIORITY_OR_OTHER||LS Mean|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.401|TWO_SIDED|95.0|-0.19|0.47||P-value for Week 8: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||0.47|-0.19|0.401
73825108|NCT00810069|147195880|SUPERIORITY_OR_OTHER||LS Mean|0.09|STANDARD_ERROR_OF_MEAN|0.19||0.618|TWO_SIDED|95.0|-0.27|0.46||P-value for Week 12: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.46|-0.27|0.618
73825109|NCT00810069|147195880|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.2||0.856|TWO_SIDED|95.0|-0.43|0.36||P-value for Week 16: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.36|-0.43|0.856
73825110|NCT00810069|147195881|SUPERIORITY_OR_OTHER||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.021|TWO_SIDED|95.0|-0.1|-0.01||P-value for Week 8: Analysis of early versus delayed intervention LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||-0.01|-0.10|0.021
73825111|NCT00810069|147195881|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.071|TWO_SIDED|95.0|-0.09|0.0||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.00|-0.09|0.071
73825112|NCT00810069|147195881|SUPERIORITY_OR_OTHER||LS Mean|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.792|TWO_SIDED|95.0|-0.05|0.06||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.06|-0.05|0.792
73825113|NCT00810069|147195882|SUPERIORITY_OR_OTHER||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.7||0.597|TWO_SIDED|95.0|-1.74|1.0||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||1.00|-1.74|0.597
73825114|NCT00810069|147195882|SUPERIORITY_OR_OTHER||LS Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.74||0.36|TWO_SIDED|95.0|-2.13|0.78||P-value for Week 12: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.78|-2.13|0.360
73825115|NCT00810069|147195882|SUPERIORITY_OR_OTHER||LS Mean|0.06|STANDARD_ERROR_OF_MEAN|0.81||0.937|TWO_SIDED|95.0|-1.52|1.65||P-value for Week 16: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||1.65|-1.52|0.937
73825116|NCT00810069|147195883|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Kaplan-Meier estimates (weeks): analysis of early intervention versus delayed intervention strategies||||0.075
73825117|NCT00810069|147195884|SUPERIORITY_OR_OTHER||Survival rate difference|-0.07||||0.116|TWO_SIDED|95.0|-0.16|0.02||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan-Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies||0.02|-0.16|0.116
73825118|NCT03675360|147195892|SUPERIORITY||Mean Difference (Net)|-0.23|||<|0.05|TWO_SIDED|95.0|-0.32|-0.14|||linear mixed effects model|||||-0.14|-0.32|<0.05
73825119|NCT03675360|147195893|SUPERIORITY||Mean Difference (Net)|-10.3|||<|0.05|TWO_SIDED|95.0|-15.6|-4.9|||linear mixed effects model|||||-4.9|-15.6|<0.05
73825120|NCT03675360|147195894|SUPERIORITY||Mean Difference (Net)|-3.2|||<|0.05|TWO_SIDED|95.0|-7.3|0.9|||linear mixed effects model|||||0.9|-7.3|<0.05
73825121|NCT03675360|147195895|SUPERIORITY||Median Difference (Final Values)|-0.13|||<|0.05|TWO_SIDED|95.0|-0.31|0.05|||linear mixed effects model|||||0.05|-0.31|<0.05
73825122|NCT03675360|147195896|SUPERIORITY||Mean Difference (Net)|-5.9|||<|0.05|TWO_SIDED|95.0|-7.4|-4.4|||linear mixed effects model|||||-4.4|-7.4|<0.05
73825123|NCT03675360|147195897|SUPERIORITY||Mean Difference (Net)|-6.2|||<|0.05|TWO_SIDED|95.0|-10.5|-2.0|||linear mixed effects model|||||-2.0|-10.5|<0.05
73825124|NCT03675360|147195898|SUPERIORITY||Mean Difference (Net)|-2.4|||<|0.05|TWO_SIDED|95.0|-3.7|-1.1|||linear mixed effects model|||||-1.1|-3.7|<0.05
73825125|NCT03675360|147195899|SUPERIORITY||Mean Difference (Net)|-2.6|||<|0.05|TWO_SIDED|95.0|-5.2|0.0|||linear mixed effects model|||||0|-5.2|<0.05
73825126|NCT03675360|147195900|SUPERIORITY||Mean Difference (Net)|-4.7|||<|0.05|TWO_SIDED|95.0|-6.7|-2.6|||linear mixed effects model|||||-2.6|-6.7|<0.05
73825127|NCT03675360|147195901|SUPERIORITY||Mean Difference (Net)|-0.8|||<|0.05|TWO_SIDED|95.0|-1.8|0.3|||linear mixed effects model|||||0.3|-1.8|<0.05
73825128|NCT04767373|147195902|OTHER||Efficacy estimate|60.4|||<|0.001|TWO_SIDED|95.0|44.1|71.9|||Exact method|One-sided p-value was estimated using an exact method.|A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- Relative Risk \[RR\]) \& 95% confidence interval (CI). The model included region, gestational age, and age at randomization as covariates.|||71.9|44.1|<0.001
73825129|NCT04767373|147195903|OTHER||Estimated Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.6|1.5|||||Estimated percentage difference beteween Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||1.5|-2.6|
73825130|NCT04767373|147195904|OTHER||Estimated Percentage Difference|-0.6|||||TWO_SIDED|95.0|-1.4|0.0|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||-0.0|-1.4|
73825131|NCT04767373|147195905|OTHER||Estimated Percentage Difference|-1.8|||||TWO_SIDED|95.0|-5.0|1.2|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||1.2|-5.0|
73825132|NCT04767373|147195906|OTHER||Estimated Percentage Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.2|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||0.2|-0.3|
73825133|NCT04767373|147195907|OTHER||Estimated Percentage Difference|0.1|||||TWO_SIDED|95.0|-0.4|0.5|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||0.5|-0.4|
73825134|NCT04767373|147195910|OTHER||Efficacy estimate|84.2|||<|0.001|TWO_SIDED|95.0|66.6|92.6||One-sided p-value was estimated using an exact method.|Exact method||A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- RR) \& 95% CI. The model included region, gestational age, and age at randomization as covariates.|||92.6|66.6|<0.001
73825135|NCT04767373|147195911|OTHER||Efficacy estimate|59.5|||||TWO_SIDED|95.0|43.3|71.1|||||A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- RR) \& 95% CI. The model included region, gestational age, and age at randomization as covariates.|||71.1|43.3|
73825136|NCT00593918|147195912|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.||||||0.04
73825137|NCT00593918|147195913|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.|Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.||||||0.14
73825138|NCT03421379|147195930|NON_INFERIORITY|The pre-defined non-inferiority margin is (10%)|Treatment Difference Wald's Method|0.0|||||TWO_SIDED|95.0|-1.47|1.47||||||||1.47|-1.47|
73825139|NCT02782741|147195936|NON_INFERIORITY|NI was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference of avalglucosidase alfa minus alglucosidase alfa was greater than (\>) -1.1.|LS mean difference|2.43|STANDARD_ERROR_OF_MEAN|1.29||0.0074|TWO_SIDED|95.0|-0.13|4.99|||mixed model for repeated measures|||Analysis performed using MMRM model with baseline FVC (% predicted, as continuous), sex, age (in years at baseline), treatment group, visit, interaction term between treatment group and visit as fixed effects.||4.99|-0.13|0.0074
73825140|NCT02782741|147195936|SUPERIORITY|A test for superiority of avalglucosidase alfa versus alglucosidase alfa was performed with an overall 5% level of significance.||||||0.0626||||||Threshold for significance at \<0.05 level.|mixed model for repeated measures|||Analysis performed using MMRM model with baseline FVC (% predicted, as continuous), sex, age (in years at baseline), treatment group, visit, interaction term between treatment group and visit as fixed effects.||||0.0626
73825141|NCT02782741|147195937|SUPERIORITY|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|30.01|STANDARD_ERROR_OF_MEAN|14.43||0.0405|TWO_SIDED|95.0|1.33|58.69|||mixed model for repeated measures|||LS mean difference was derived from MMRM model with baseline FVC (% predicted) and baseline 6MWT (distance walked in meter), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||58.69|1.33|0.0405
73825142|NCT02782741|147195938|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|3.13|STANDARD_ERROR_OF_MEAN|5.24||0.5522|TWO_SIDED|95.0|-7.31|13.57|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for MIP % predicted adjusted for MIP % predicted at baseline, age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||13.57|-7.31|0.5522
73896537|NCT03456882|147326405|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4401|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.4401
73825143|NCT02782741|147195939|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|5.64||0.7321|TWO_SIDED|95.0|-13.17|9.29|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for MEP % predicted adjusted for MEP % predicted at baseline, age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||9.29|-13.17|0.7321
73825144|NCT02782741|147195940|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|106.97|STANDARD_ERROR_OF_MEAN|67.17||0.115|TWO_SIDED|95.0|-26.56|240.5|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for HHD lower extremity muscle strength composite score adjusted for summary HHD lower extremity score at baseline, baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||240.50|-26.56|0.1150
73825145|NCT02782741|147195941|OTHER|No formal testing of additional secondary endpoint of QMFT.|LS mean difference|2.08|STANDARD_ERROR_OF_MEAN|0.94||0.0288|TWO_SIDED|95.0|0.22|3.95||Nominal p-value.|mixed model for repeated measures|||LS mean difference was derived from MMRM models adjust for total QMFT score at baseline, baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||3.95|0.22|0.0288
73825146|NCT02782741|147195942|OTHER|No formal testing of additional secondary endpoint of SF-12.|Score difference|0.77|STANDARD_ERROR_OF_MEAN|1.46||0.5996|TWO_SIDED|95.0|-2.13|3.67|||mixed model for repeated measures|||The MMRM models adjust for baseline score (PCS), baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||3.67|-2.13|0.5996
73825147|NCT02782741|147195942|OTHER|No formal testing of additional secondary endpoint of SF-12.|Score difference|2.12|STANDARD_ERROR_OF_MEAN|1.8||0.2427|TWO_SIDED|95.0|-1.46|5.69|||mixed model for repeated measures|||The MMRM models adjust for baseline score (MCS), baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||5.69|-1.46|0.2427
73825148|NCT00196105|147195971|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||Log Rank|||||||.057
73825149|NCT00196105|147195972|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||.04
73825150|NCT00196105|147195972|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Death is censored for Kaplan-Meier analysis.|Log Rank|||||||.007
73825151|NCT00196105|147195972|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Chi-squared|||||||.69
73825152|NCT00196105|147195972|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is adjusted for multiple comparisons.|Chi-squared|||6 mm Zilver vs. 10 mm Zilver and 10 mm Wallstent combined||||.02
73825153|NCT00196105|147195973|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||.16
73825154|NCT00196105|147195975|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Log Rank|||||||.32
73825155|NCT00196105|147195975|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Kruskal-Wallis|||||||.69
73825156|NCT04863872|147195976|OTHER|Difference|Risk Ratio (RR)|0.72||||0.27|TWO_SIDED|95.0|0.39|1.3|||Poisson regression|Poisson regression with binary primary outcome, estimated using Generalized Estimating Equations (GEE) and robust variance estimation.||||1.30|0.39|0.27
73825157|NCT02864407|147196045|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
73825158|NCT02864407|147196046|OTHER||||||<|0.0001||||||p-value for difference of Week 52 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
73825159|NCT02864407|147196047|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
73825160|NCT02864407|147196048|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
73825161|NCT02864407|147196049|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.||||||<0.0001
73825162|NCT02864407|147196050|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.||||||<0.0001
73825163|NCT02864407|147196051|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.||||||<0.0001
73825164|NCT02864407|147196052|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.||||||<0.0001
73825165|NCT02864407|147196053|OTHER||||||<|0.0001||||||p-value for difference of Week 24 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
73825166|NCT02864407|147196054|OTHER||||||<|0.0001||||||p-value for difference of 52±2 weeks versus Baseline.|Paired t-test|||||||<0.0001
73825167|NCT02864407|147196055|OTHER||||||<|0.0001||||||p-value for difference of Week 24 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
73825168|NCT02864407|147196056|OTHER||||||<|0.0001||||||p-value for difference of Week 52 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
73825169|NCT04577794|147196068|SUPERIORITY||Least square (LS) mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.02||0.981|TWO_SIDED|90.0|-1.7|1.7|||ANCOVA|||An analysis of covariance (ANCOVA) was used with a multiple imputation method to handle missing values, with treatment as fixed effect and baseline score as covariate.||1.7|-1.7|0.981
73825170|NCT02849080|147196071|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.89|6.7||Unadjusted two-sided p-value for test of no difference from 1.|Pattern mixture model||Oral Semaglutide flex / Sitagliptin 100 mg.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||6.70|2.89|<0.0001
73825171|NCT02849080|147196071|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Odds Ratio (OR)|5.54|||<|0.0001|TWO_SIDED|95.0|3.54|8.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Logistic||Oral Semaglutide flex / Sitagliptin 100 mg|The analysis was based on multiple imputation, imputing sequentially using post-baseline measurements up to and including week 52. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||8.68|3.54|<0.0001
73825172|NCT02849080|147196072|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixture model||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||-1.2|-2.6|<0.0001
73825173|NCT02849080|147196072|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a Mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 52. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.5|-2.9|<0.0001
73825174|NCT02849080|147196089|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.09|0.39||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.39|0.09|<0.0001
73825175|NCT02849080|147196090|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.58||||0.0175|TWO_SIDED|95.0|0.37|0.91||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.||0.91|0.37|0.0175
73825176|NCT02849080|147196109|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77||||0.4381|TWO_SIDED|95.0|0.39|1.5||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.||1.50|0.39|0.4381
73825177|NCT02849080|147196110|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.47||||0.079|TWO_SIDED|95.0|0.2|1.09||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.09|0.20|0.0790
73825178|NCT03839394|147196153|OTHER|||||||0.012|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.012
73825179|NCT03839394|147196154|OTHER|||||||0.05|||||||Z-test of Proportions|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.05
73825180|NCT03839394|147196155|OTHER|||||||0.75|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.750
73825181|NCT03839394|147196156|OTHER|||||||0.86|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.860
73825182|NCT03839394|147196157|OTHER|||||||0.76|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.760
73825183|NCT03101150|147196163|OTHER|A sample size of minimum 152 was calculated to be able to determine incidence of preeclampsia that is in the range of 8-17% with 80% power assuming an alpha of 5%.|Risk Ratio (RR)|0.163|||<|0.05|TWO_SIDED|95.0|0.02|1.32|||Chi-squared|||Eligible and consented study subjects were randomized according to permuted block design scheme to be allocated in 400 IU arm and 4000 IU arm.||1.32|0.02|<0.05
73825184|NCT03101150|147196164|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73825185|NCT03101150|147196165|OTHER||Risk Ratio (RR)|0.43|||<|0.02|TWO_SIDED|95.0|0.19|0.94|||Chi-squared|||||0.94|0.19|<0.02
73825186|NCT00490035|147196315|SUPERIORITY_OR_OTHER_LEGACY||Percentage Reduction over Placebo|6.5|||=|0.261|TWO_SIDED|95.0|-5.2|16.9|||ANCOVA|||In order to control the Type I error testing was performed in sequence starting with 50 mg, then 100 mg and finally 20 mg Brivaracetam per day versus Placebo, only moving to the next test if the previous one was significant at the 5 % level.||16.9|-5.2|=0.261
73825187|NCT03519009|147196338|SUPERIORITY||Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|1.8|6.3|||longitudinal logistic regression|||||6.3|1.8|<0.001
73825188|NCT03519009|147196339|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|1.5|4.4|||longitudinal logistic regression|||||4.4|1.5|<0.001
73825189|NCT00731822|147196340|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|||||TWO_SIDED|95.0|-3.9|5.1||||||||5.1|-3.9|
73825190|NCT04585919|147196344|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|Generalized linear mixed effect model controlling for secular trend, patient sociodemographic and health characteristics||||||0.005
73825191|NCT04585919|147196345|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Generalized linear mixed effect model controlling for secular trend, patient sociodemographic and health characteristics||||||0.19
73825192|NCT03877744|147196349|NON_INFERIORITY|Non-inferiority margin of 2.5 was set prior to study initiation with a Type I error of 0.025.|Mean Difference (Final Values)|1.6873|STANDARD_ERROR_OF_MEAN|0.2558||0.0008|ONE_SIDED|97.5||2.1894|||Mixed Models Analysis|Controls technician,site,seat type;Techn. nested in site modeled as random effect;Model allowed heterogeneous variances across arms w Kenward-Roger df|Mixed model allowed the arms to have unequal variance estimates. Degrees of freedom estimated using Kenward-Rogers.|||2.1894||0.0008
73825193|NCT05209880|147196350|SUPERIORITY|||||||0.5835|||||||Wilcoxon (Mann-Whitney)|||||||0.5835
73825194|NCT04817332|147196360|SUPERIORITY||Odds Ratio (OR)|0.72||||0.008|TWO_SIDED|95.0|0.57|0.92|||Odds ratio Ordinal Logistic Regression|adjusted for the stratifying factors of age as a fixed effect and site using robust standard errors to account for clustering||||0.92|0.57|0.008
73825195|NCT04817332|147196361|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.058|TWO_SIDED|95.0|0.76|1.0|||Regression, Cox|||||1.00|0.76|0.058
73825196|NCT04817332|147196364|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.84|1.13||||||||1.13|0.84|
73825197|NCT04817332|147196366|SUPERIORITY||Rate ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99||||||||0.99|0.87|
73825198|NCT04817332|147196367|SUPERIORITY||Rate ratio|1.13|||||TWO_SIDED|95.0|0.73|1.74||||||||1.74|0.73|
73825199|NCT04817332|147196368|SUPERIORITY||Rate ratio|0.84|||||TWO_SIDED|95.0|0.69|1.04||||||||1.04|0.69|
73825200|NCT04817332|147196369|SUPERIORITY||Rate ratio|1.68|||||TWO_SIDED|95.0|1.09|2.58||||||||2.58|1.09|
73825201|NCT04817332|147196370|SUPERIORITY||Rate ratio|1.03|||||TWO_SIDED|95.0|0.92|1.15||||||||1.15|0.92|
73825202|NCT04817332|147196371|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|1.06|1.88||||||||1.88|1.06|
73825203|NCT04817332|147196385|SUPERIORITY||Mean Difference (Final Values)|-67.0|||||TWO_SIDED|95.0|-102.0|-31.0||||||||-31|-102|
73825204|NCT04817332|147196389|SUPERIORITY||Mean Difference (Final Values)|0.003|||||TWO_SIDED|95.0|-0.06|0.066||||||||0.066|-0.06|
73825205|NCT04795466|147196396|SUPERIORITY||Least square mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.1442||0.6386|TWO_SIDED|90.0|-0.178|0.316|||Mixed Models Analysis|||NTB Total z-score - day 171||0.316|-0.178|0.6386
73825206|NCT04795466|147196397|SUPERIORITY||Least squares mean difference|-0.002|STANDARD_ERROR_OF_MEAN|0.1739||0.9917|TWO_SIDED|90.0|-0.3|0.296|||Mixed Models Analysis|||Memory function - day 171||0.296|-0.300|0.9917
73825207|NCT04795466|147196398|SUPERIORITY||least squares mean difference|0.186|STANDARD_ERROR_OF_MEAN|0.1958||0.351|TWO_SIDED|90.0|-0.148|0.52|||Mixed Models Analysis|||Executive function- day 171||0.520|-0.148|0.3510
73825208|NCT04795466|147196399|SUPERIORITY||Repeated measures analysis|-0.49|STANDARD_ERROR_OF_MEAN|1.8||0.787|TWO_SIDED|90.0|-3.56|2.58|||Mixed Models Analysis|||DSST - day 171||2.58|-3.56|0.7870
73825209|NCT01435759|147196435|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean|3.16|STANDARD_ERROR_OF_MEAN|1.01||0.004|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.14, was based on MCP-Mod Analysis for the candidate model EMax.|||||0.004
73825210|NCT01435759|147196435|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.5|STANDARD_ERROR_OF_MEAN|1.01||0.032|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.48, was based on MCP-Mod Analysis for the candidate model Exponential.|||||0.032
73825211|NCT01435759|147196435|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean|3.28|STANDARD_ERROR_OF_MEAN|1.01||0.003|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.26 was based on MCP-Mod Analysis for the candidate model Linear.|||||0.003
73825212|NCT01435759|147196435|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.91|STANDARD_ERROR_OF_MEAN|1.01||0.01|TWO_SIDED||||||MCP-Mod Analysis Method|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.88, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||0.010
73825213|NCT01435759|147196435|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|3.15|STANDARD_ERROR_OF_MEAN|1.01||0.005|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.12, was based on MCP-Mod Analysis for the candidate model Logistic2.|||||0.005
73825214|NCT01435759|147196436|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.16|STANDARD_ERROR_OF_MEAN|0.75||0.011|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.86 was based on MCP-Mod Analysis for the candidate model Emax.|||||0.011
73825215|NCT01435759|147196436|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|1.95|STANDARD_ERROR_OF_MEAN|0.75||0.023|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.59, was based on MCP-Mod Analysis for the candidate model Exponential.|||||0.023
73825216|NCT01435759|147196436|SUPERIORITY_OR_OTHER_LEGACY||MCP-Mod Analysis|2.47|STANDARD_ERROR_OF_MEAN|0.75||0.003|TWO_SIDED||||||Least Squares Means|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.28, was based on MCP-Mod Analysis for the candidate model Linear.|||||0.003
73825217|NCT01435759|147196436|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.22|STANDARD_ERROR_OF_MEAN|0.76||0.009|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.93, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||0.009
73825218|NCT01435759|147196436|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.37|STANDARD_ERROR_OF_MEAN|0.76||0.005|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.13, was based on MCP-Mod Analysis for the candidate model Logistic2.|||||0.005
73825219|NCT01435759|147196437|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.45|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.24, was based on MCP-Mod Analysis for the candidate model Emax|||||<0.001
73825220|NCT01435759|147196437|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|3.52|STANDARD_ERROR_OF_MEAN|1.05||0.002|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.36, was based on MCP-Mod Analysis for the candidate model Expontential.|||||0.002
73825221|NCT01435759|147196437|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.3|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.10, was based on MCP-Mod Analysis for the candidate model Linear.|||||<0.001
73825222|NCT01435759|147196437|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.63|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||<0.001
73825223|NCT01435759|147196437|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.63|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39 was based on MCP-Mod Analysis for the candidate model Logistic2.|||||<0.001
73825224|NCT01435759|147196438|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|-0.11|STANDARD_ERROR_OF_MEAN|1.07||1|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis Method|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.10, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Betamod.|Analysis of Dose-Response Using the MCP-Mod Analysis Method||||1.000
73825225|NCT01435759|147196438|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|0.43|STANDARD_ERROR_OF_MEAN|1.06||0.942|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.41, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Emax.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.||||0.942
73825226|NCT01435759|147196438|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|0.21|STANDARD_ERROR_OF_MEAN|1.06||0.995|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.20, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Linear.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.||||0.995
73825227|NCT01435759|147196438|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|-0.32|STANDARD_ERROR_OF_MEAN|1.07||0.978|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.30, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Logistic.|Analysis of Dose-Response Using the MCP-Mod Analysis Method||||0.978
73825228|NCT02849587|147196444|SUPERIORITY||||||<|0.001|||||||Generalized least squares model|||||||<0.001
73825229|NCT02849587|147196445|SUPERIORITY|||||||0.022|||||||Generalized least squares model|Raw data converted to z-score based on pre-smoking performance of entire sample.||||||0.022
73825230|NCT02849587|147196446|SUPERIORITY|||||||0.283|||||||Generalized least squares model|||||||0.283
73825231|NCT02849587|147196447|SUPERIORITY|||||||0.0503|||||||Generalized estimating equations model|||||||0.0503
73825232|NCT02849587|147196448|SUPERIORITY|||||||0.024|||||||Generalized least squares model|||||||0.024
73825233|NCT02849587|147196449|SUPERIORITY|||||||0.716|||||||Generalized least squares model|The outcome was standardized prior to analyses.||||||0.716
73825234|NCT02849587|147196450|SUPERIORITY|||||||0.005|||||||Generalized least squares model|The outcome was standardized prior to analysis.||||||0.005
73825235|NCT02849587|147196451|SUPERIORITY|||||||0.366|||||||Generalized Estimating Equations model|||||||.366
73825236|NCT02849587|147196452|SUPERIORITY|||||||0.225|||||||Generalized least squares model|Outcome was log10 transformed prior to analyses.||||||.225
73825237|NCT02849587|147196453|SUPERIORITY|||||||0.592|||||||Generalized least squares model|The outcome was transformed using logit function prior to analyses. Model included treatment (3 groups), time (5 times), and their interaction.||||||.592
73825238|NCT02849587|147196454|SUPERIORITY|||||||0.294|||||||Generalized least squares model|||||||.294
73825239|NCT02849587|147196455|SUPERIORITY|||||||0.144|||||||Generalized least squares model|||||||.144
73825240|NCT02849587|147196456|OTHER|Spearman's correlation||||||0.09|||||||Spearman's correlation|||||||0.090
73825241|NCT02849587|147196456|OTHER|Spearman's correlation||||||0.0006|||||||Spearman's correlation|||||||.0006
73825242|NCT02849587|147196456|OTHER|Spearman's correlation||||||0.053|||||||Spearman's correlation|||||||0.053
73825243|NCT02849587|147196457|OTHER|Spearman's correlation||||||0.3|||||||Spearman's correlation|||||||0.300
73825244|NCT02849587|147196457|OTHER|Spearman's correlation||||||0.038|||||||Spearman's correlation|||||||0.038
73825245|NCT02849587|147196457|OTHER|Spearman's correlation||||||0.175|||||||Spearman's correlation|||||||0.175
73825246|NCT04195061|147196468|SUPERIORITY|||||||0.303|||||||t-test, 2 sided|||||||0.303
73825247|NCT04195061|147196469|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
73825248|NCT04195061|147196470|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
73825249|NCT00810199|147196476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.2055|TWO_SIDED|95.0|0.882|1.799||Cochran-Mantel-Haenszel test stratified by region and baseline DAS28 (≤5.5 and \>5.5).|Cochran-Mantel-Haenszel|||||1.799|0.882|0.2055
73825250|NCT00810199|147196476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.1894|TWO_SIDED|95.0|0.889|1.814||Logistic regression including treatment , region and baseline DAS28.|Regression, Logistic|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.||||1.814|0.889|0.1894
73825251|NCT00810199|147196477|SUPERIORITY_OR_OTHER|||||||0.8742||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.8742
73825252|NCT00810199|147196477|SUPERIORITY_OR_OTHER|||||||0.6212||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.6212
73825253|NCT00810199|147196477|SUPERIORITY_OR_OTHER|||||||0.0963||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.0963
73825254|NCT00810199|147196478|SUPERIORITY_OR_OTHER|||||||0.2969||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.2969
73825255|NCT00810199|147196478|SUPERIORITY_OR_OTHER|||||||0.2215||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.2215
73825256|NCT00810199|147196478|SUPERIORITY_OR_OTHER|||||||0.1243||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.1243
73825257|NCT00810199|147196479|SUPERIORITY_OR_OTHER|||||||0.6775||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.6775
73825258|NCT00810199|147196479|SUPERIORITY_OR_OTHER|||||||0.9976||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.9976
73825259|NCT00810199|147196479|SUPERIORITY_OR_OTHER|||||||0.2168||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.2168
73825260|NCT00810199|147196480|SUPERIORITY_OR_OTHER|||||||0.8369||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.8369
73825261|NCT00810199|147196480|SUPERIORITY_OR_OTHER|||||||0.6528||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.6528
73825262|NCT00810199|147196480|SUPERIORITY_OR_OTHER|||||||0.2546||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.2546
73825263|NCT00810199|147196481|SUPERIORITY_OR_OTHER|||||||0.1018|||||||Log Rank|||||||0.1018
73825264|NCT00810199|147196482|SUPERIORITY_OR_OTHER|||||||0.7176|||||||Log Rank|||||||0.7176
73825265|NCT00810199|147196483|SUPERIORITY_OR_OTHER|||||||0.8526|||||||Log Rank|||||||0.8526
73825266|NCT00810199|147196484|SUPERIORITY_OR_OTHER|||||||0.2217|||||||Log Rank|||||||0.2217
73825267|NCT00810199|147196485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0008|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|Baseline DAS28 as a covariate.||||-0.11|-0.41|0.0008
73825268|NCT00810199|147196486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0245|TWO_SIDED|95.0|1.053|2.109|||Regression, Logistic|Logistic regression including treatment, region and baseline DAS28.|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.|||2.109|1.053|0.0245
73825269|NCT00810199|147196486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.482||||0.0258||95.0|1.048|2.095||Stratified by region and baseline DAS28 (≤ 5.5 and \> 5.5).|Cochran-Mantel-Haenszel|||||2.095|1.048|0.0258
73825270|NCT00810199|147196487|SUPERIORITY_OR_OTHER|||||||0.0287||95.0|||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 24||||0.0287
73825271|NCT00810199|147196487|SUPERIORITY_OR_OTHER|||||||0.224|||||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 52||||0.2240
73825272|NCT00810199|147196488|SUPERIORITY_OR_OTHER|||||||0.0497||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.0497
73825273|NCT00810199|147196488|SUPERIORITY_OR_OTHER|||||||0.3918|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.3918
73825274|NCT00810199|147196489|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.0019
73825275|NCT00810199|147196489|SUPERIORITY_OR_OTHER|||||||0.1181|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.1181
73825276|NCT00810199|147196490|SUPERIORITY_OR_OTHER|||||||0.7776||||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24||||0.7776
73825277|NCT00810199|147196490|SUPERIORITY_OR_OTHER|||||||0.8843|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.8843
73825278|NCT00810199|147196491|SUPERIORITY_OR_OTHER|||||||0.9095||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9095
73825279|NCT00810199|147196491|SUPERIORITY_OR_OTHER|||||||0.7179|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.7179
73825280|NCT00810199|147196492|SUPERIORITY_OR_OTHER|||||||0.3113||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.3113
73825281|NCT00810199|147196492|SUPERIORITY_OR_OTHER|||||||0.2931||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.2931
73825282|NCT00810199|147196493|SUPERIORITY_OR_OTHER|||||||0.2451||95.0||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24||||0.2451
73825283|NCT00810199|147196493|SUPERIORITY_OR_OTHER|||||||0.8841||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.8841
73825284|NCT00810199|147196494|SUPERIORITY_OR_OTHER|||||||0.9655||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9655
73825285|NCT00810199|147196494|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.0308
73825286|NCT00810199|147196495|SUPERIORITY_OR_OTHER|||||||0.5186||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.5186
73825287|NCT00810199|147196495|SUPERIORITY_OR_OTHER|||||||0.7706||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.7706
73825288|NCT00810199|147196496|SUPERIORITY_OR_OTHER|||||||0.6067||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.6067
73825289|NCT00810199|147196496|SUPERIORITY_OR_OTHER|||||||0.681||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.6810
73825290|NCT00810199|147196497|SUPERIORITY_OR_OTHER|||||||0.9323||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9323
73825291|NCT00810199|147196497|SUPERIORITY_OR_OTHER|||||||0.1448||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.1448
73825292|NCT00810199|147196498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.2034|TWO_SIDED|95.0|-0.43|0.09||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||0.09|-0.43|0.2034
73825293|NCT00810199|147196498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.3611|TWO_SIDED|95.0|-0.88|0.32||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||0.32|-0.88|0.3611
73825294|NCT00810199|147196498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0342|TWO_SIDED|95.0|-1.16|-0.05||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||-0.05|-1.16|0.0342
73825295|NCT00810199|147196499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7095|TWO_SIDED|95.0|-0.23|0.16||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||0.16|-0.23|0.7095
73825296|NCT00810199|147196499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.8147|TWO_SIDED|95.0|-0.45|0.57||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||0.57|-0.45|0.8147
73825297|NCT00810199|147196499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0778|TWO_SIDED|95.0|-0.67|0.04||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||0.04|-0.67|0.0778
73825298|NCT00810199|147196500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0441|TWO_SIDED|95.0|-0.25|0.0||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||-0.00|-0.25|0.0441
73825299|NCT00810199|147196500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0012|TWO_SIDED|95.0|-0.54|-0.13||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||-0.13|-0.54|0.0012
73825300|NCT00810199|147196500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0372|TWO_SIDED|95.0|-0.56|-0.02||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||-0.02|-0.56|0.0372
73825301|NCT00810199|147196501|SUPERIORITY_OR_OTHER||Difference|6.75||||0.0694|TWO_SIDED|95.0|-1.02|14.52|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||Week 52||14.52|-1.02|0.0694
73825302|NCT00810199|147196501|SUPERIORITY_OR_OTHER|||||||0.1695|TWO_SIDED||||||Log Rank|||Week 104||||0.1695
73825303|NCT00810199|147196502|SUPERIORITY_OR_OTHER||Difference|-2.91||||0.0496||95.0|-5.86|0.05|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||||0.05|-5.86|0.0496
73825304|NCT00810199|147196503|SUPERIORITY_OR_OTHER||Difference|-1.48||||0.5188|TWO_SIDED|95.0|-6.59|3.62|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||||3.62|-6.59|0.5188
73825305|NCT00810199|147196504|SUPERIORITY_OR_OTHER|||||||0.2652|||||||Wilcoxon (Mann-Whitney)|||Week 24||||0.2652
73825306|NCT00810199|147196504|SUPERIORITY_OR_OTHER|||||||0.197|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.1970
73825307|NCT00810199|147196504|SUPERIORITY_OR_OTHER|||||||0.1671|||||||Wilcoxon (Mann-Whitney)|||||||0.1671
73825308|NCT00810199|147196506|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Wald CI)|5.22||||0.111|TWO_SIDED|95.0|-1.2|11.64|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and \> 5.5) as fixed factors.||||11.64|-1.20|0.1110
73825309|NCT00810199|147196507|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Wald CI)|-2.11||||0.6027|TWO_SIDED|95.0|-10.07|5.85|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and \> 5.5) as fixed factors.||||5.85|-10.07|0.6027
73825310|NCT00810199|147196508|SUPERIORITY_OR_OTHER|||||||0.1695|||||||Log Rank|||||||0.1695
73825311|NCT00810199|147196509|SUPERIORITY_OR_OTHER|||||||0.0096|||||||Log Rank|||||||0.0096
73825312|NCT00810199|147196510|SUPERIORITY_OR_OTHER|||||||0.0734|||||||Log Rank|||||||0.0734
73825313|NCT00791219|147196514|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|6.47|||||ONE_SIDED|95.0|-1.77||||||||||-1.77|
73825314|NCT00791219|147196514|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
73896538|NCT03456882|147326406|SUPERIORITY||difference between mean slopes|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5725|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction||Contrast of the slopes during the on-treatment period (change per week, from baseline to week 24) between treatment groups. Null hypothesis: the rate of change from baseline to week 24 is not different between groups.||||0.5725
73825315|NCT00791219|147196515|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|10.38|||||ONE_SIDED|95.0|0.92|||||||To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|||0.92|
73825316|NCT00791219|147196515|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
73825317|NCT00791219|147196516|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|3.17|||||ONE_SIDED|95.0|-10.62||||||||||-10.62|
73825318|NCT00791219|147196516|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
73825319|NCT00791219|147196519|NON_INFERIORITY|If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure or Mycological Cure as appropriate at Visit 7 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|-0.57|||||ONE_SIDED|95.0|-12.91|||||||If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure or Mycological Cure as appropriate at Visit 7 was greater than -20 then non-inferiority was considered to have been demonstrated|||-12.91|
73825320|NCT00791219|147196520|SUPERIORITY||Mean Difference (Final Values)|0.0018|||<|0.05|TWO_SIDED|||||It the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated.|A one-sided continuity corrected Z-test|||For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.||||<0.05
73825321|NCT00791219|147196520|SUPERIORITY||Median Difference (Final Values)|0.0853|||<|0.05|TWO_SIDED||||||A one-sided continuity corrected Z-test|||For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.||||<0.05
73825322|NCT01107925|147196541|NON_INFERIORITY_OR_EQUIVALENCE|Difference in median MPA in response to 20 μM ADP in LBW participants who received 5 mg prasugrel to the 75th percentile of MPA response to 20 μM ADP in HBW participants who received10 mg prasugrel at the end of Study Period 1 (Baseline through Day 12) was estimated from the observed data.|Estimate of the difference|-10.1||||0.526|TWO_SIDED|95.0|-23.4|0.2|||bootstrap (to determine 95% CI)||Estimate of the difference = \[median (low body weight) - Q3 (higher body weight)\]|||0.20|-23.40|0.526
73825323|NCT03311945|147196546|OTHER||||||||||||||||||This was a single-arm study without a comparator group; therefore, no formal hypothesis testing was conducted. The primary endpoint-therapeutic failure at 48 weeks-was analyzed descriptively. The proportion of participants experiencing therapeutic failure was calculated for both the intention-to-treat (ITT) and on-treatment (OT) populations. Exact binomial (Clopper-Pearson) 95% confidence intervals were used to estimate the failure rates.|||
73825324|NCT00490919|147196614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.225||0.0104|TWO_SIDED|95.0|-1.02|-0.14|||Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Double-blind analysis (comparison between BTDS and placebo TDS) at week 12 of the double-blind phase.|Missing average pain over the last 24 hours scores after treatment discontinuation were imputed using BOCF for adverse event-related withdrawals and LOCF for withdrawals due to other reasons.||-0.14|-1.02|.0104
73825325|NCT00490919|147196615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.124|STANDARD_ERROR_OF_MEAN|0.0874||0.1586|TWO_SIDED|95.0|-0.296|0.048||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||Mean comparison from weeks 2-12 of the double-blind phase.|||0.048|-0.296|.1586
73825326|NCT00490919|147196616|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.605||0.0062|TWO_SIDED|95.0|-7.55|-1.25||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Treatment comparison over Weeks 4, 8, and 12.|The primary comparison between groups was based on estimates and contrasts for the weeks 4, 8, and 12 mean values.||-1.25|-7.55|.0062
73825327|NCT03163446|147196619|OTHER|Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|10.4||||0.3137|TWO_SIDED|90.0|-6.35|27.19|||Fisher Exact|||||27.19|-6.35|0.3137
73825328|NCT03163446|147196629|OTHER|P-value was ad hoc. Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|42.8||||0.0101|TWO_SIDED|90.0|14.3|71.4|||Fisher Exact|||||71.4|14.3|0.0101
73825329|NCT03163446|147196630|OTHER|P value was ad hoc. Descriptive statistics were performed.||||||0.0646|||||||Fisher Exact||||Descriptive statistics were performed.|||0.0646
73825330|NCT03163446|147196632|OTHER|P-value was ad hoc. Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|-21.3||||0.0556|TWO_SIDED|90.0|-45.1|2.5|||Fisher Exact|||||2.5|-45.1|0.0556
73825331|NCT01228591|147196650|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05logMAR.|Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.0059|||TWO_SIDED|95.0|-0.0044|0.0187|||Mixed Models Analysis||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"For Low Luminance/ High Contrast grouping (Monocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance)."||0.0187|-0.0044|
73825332|NCT01228591|147196650|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.0059|||TWO_SIDED|95.0|-0.0086|0.0146|||Mixed Models Analysis||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"High Luminance/ Low Contrast grouping (Binocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance)."||0.0146|-0.0086|
73825333|NCT01228591|147196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0061|||TWO_SIDED|95.0|0.0041|0.0282|||Mixed Models Analysis||Mean difference represents: Test lens (Advance Plus) - Control lens (Advance).|"For Low Luminance/ High Contrast Grouping (Monocular):~Ho: The test lens (Advance Plus) will be non-inferior to the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance)."||0.0282|0.0041|
73825334|NCT01228591|147196651|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.009|0.3305|||Mixed Models Analysis||Mean Difference is defined to be: test lens (Advance Plus) - control lens (Advance).|"For High Luminance/ Low Contrast Grouping (Binocular):~Ho: The test lens (Advance Plus) will be non-inferior from the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance)."||0.3305|0.0090|
73825335|NCT01921517|147196656|SUPERIORITY|||||||0.0481|||||||t-test, 2 sided|||||||0.0481
73825336|NCT01298700|147196728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.148|TWO_SIDED|95.0|-11.0|1.9||P-value was stratified by baseline prostaglandin analogue (PGA) treatment(yes/no) and by baseline active ocular surface finding (present/absent).|Cochran-Mantel-Haenszel||bimatoprost 0.01% ophthalmic solution - bimatoprost 0.03% ophthalmic solution|||1.9|-11|0.148
73825337|NCT00129441|147196730|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
73825338|NCT00129441|147196731|SUPERIORITY_OR_OTHER|||||||0.162||95.0|||||ANOVA|||||||0.162
73825339|NCT00129441|147196732|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||||||0.12
73825340|NCT00129441|147196733|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
73825341|NCT00129441|147196734|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||ANOVA|||||||0.249
73825342|NCT00129441|147196735|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|||At week 4, mean BPRS total scores were nearly the same for the placebo group and L-830982 group as a result of a significant reduction in positive symptoms reported for the placebo group (F=9.12, df=1,13, p=0.01). For the L-830982-treated group, neither total BPRS scores nor any of the factor scores changed over the course of the trial.||||0.01
73825343|NCT00129441|147196736|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73825344|NCT00129441|147196737|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
73825345|NCT04006145|147196738|SUPERIORITY||LS-Means Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.184||0.029|TWO_SIDED|95.0|-0.76|-0.04|||ANCOVA|||Change from baseline in serum LDL-C at Week 16 was analyzed using ANCOVA after the missing data imputation, with treatment group as a factor, baseline serum LDL-C, baseline LDL-C-by-treatment interaction values, and baseline lipid-lowering medications (Yes or No) as covariates. Missing data for serum LDL-C was imputed through multiple imputation method as described in the statistical analysis plan (SAP).||-0.04|-0.76|0.029
73825346|NCT00643760|147196752|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.35||||0.295||95.0|-1.02|0.31||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.31|-1.02|0.295
73825347|NCT00643760|147196752|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.02||||0.946||95.0|-0.71|0.66||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.66|-0.71|0.946
73825348|NCT00643760|147196752|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.55||||0.105||95.0|-1.1|0.01||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.01|-1.10|0.105
73825349|NCT00643760|147196752|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|0.43||||||95.0|-0.22|1.08||||||||1.08|-0.22|
73825350|NCT00104052|147196777|SUPERIORITY_OR_OTHER||Normal approximation to the binomial|0.654||||||95.0|0.564|0.744||||||||0.744|0.564|
73825351|NCT02452047|147196820|OTHER|Difference in percentages|Difference in FOR %|-7.3|||||TWO_SIDED|90.0|-27.5|21.4|||||Stratified Miettinen \& Nurminen method by infection type|||21.4|-27.5|
73825352|NCT02452047|147196821|OTHER|Difference in percentages|Difference in AE %|-10.3|||||TWO_SIDED|95.0|-33.1|18.0|||||Miettinen \& Nurminen method|||18.0|-33.1|
73825353|NCT02452047|147196822|OTHER|Difference in percentages|Difference in SAE %|-21.6|||||TWO_SIDED|95.0|-47.8|1.3|||||Miettinen \& Nurminen method|||1.3|-47.8|
73825354|NCT02452047|147196823|OTHER|Difference in percentages|Difference in drug-related AE %|-15.1|||||TWO_SIDED|95.0|-42.3|9.2|||||Miettinen \& Nurminen method|||9.2|-42.3|
73825355|NCT02452047|147196824|OTHER|Difference in percentages|Difference in drug-related SAE %|0.0|||||TWO_SIDED|95.0|-19.7|11.2|||||Miettinen \& Nurminen method|||11.2|-19.7|
73825356|NCT02452047|147196825|OTHER|Difference in percentages|Difference in discontinuation %|-18.8|||||TWO_SIDED|95.0|-43.3|-6.2|||||Miettinen \& Nurminen method|||-6.2|-43.3|
73825357|NCT02452047|147196826|OTHER|Difference in percentages|Difference in drug-related discon %|-12.5|||||TWO_SIDED|95.0|-36.3|-0.3|||||Miettinen \& Nurminen method|||-0.3|-36.3|
73825358|NCT02452047|147196827|OTHER|Difference in percentages|Difference in pyrexia %|0.4|||||TWO_SIDED|95.0|-25.2|19.7|||||Miettinen \& Nurminen method|||19.7|-25.2|
73825359|NCT02452047|147196827|OTHER|Difference in percentages|Difference blood creatinine inc %|-25.0|||||TWO_SIDED|95.0|-49.8|-10.1|||||Miettinen \& Nurminen method|||-10.1|-49.8|
73825360|NCT02452047|147196828|OTHER|Difference in Category 1 ECI %|Difference in Category 1 ECI %|-12.5||||0.047|TWO_SIDED|95.0|-36.3|-0.3|||Miettinen and Nurminen method|||||-0.3|-36.3|0.047
73825361|NCT02452047|147196828|OTHER|Difference in Category 2 ECI %|Difference in Category 2 ECI %|-12.5||||0.047||95.0|-36.3|-0.3|||Miettinen and Nurminen method|||||-0.3|-36.3|0.047
73825362|NCT02452047|147196829|OTHER|Difference in percentages|Difference in nephrotoxicity %|-45.9||||0.002||95.0|-69.1|-18.4|||Fisher Exact||Miettinen \& Nurminen method|||-18.4|-69.1|0.002
73825363|NCT02452047|147196830|OTHER|Difference in Day 28 FCR %|Difference in Day 28 FCR %|26.3|||||TWO_SIDED|90.0|1.3|51.5|||||Miettinen and Nurminen method stratified by infection-site stratum|||51.5|1.3|
73825364|NCT02452047|147196831|OTHER|Difference in mortality %|Difference in mortality %|-17.3|||||TWO_SIDED|90.0|-46.4|6.7|||||Miettinen and Nurminen method stratified by infection-site stratum|||6.7|-46.4|
73825365|NCT02452047|147196832|OTHER|Adjusted difference in OTX FCR %|Adjusted difference in OTX FCR %|33.9|||||TWO_SIDED|90.0|7.4|61.1|||||Miettinen and Nurminen method stratified by infection-site stratum|||61.1|7.4|
73825366|NCT02452047|147196833|OTHER|Adjusted difference in EOT FCR %|Adjusted difference in EOT FCR %|25.4|||||TWO_SIDED|90.0|3.1|53.6|||||Miettinen and Nurminen method stratified by infection-site stratum|||53.6|3.1|
73825367|NCT02452047|147196834|OTHER|Adjusted difference in EFU FCR %|Difference in EFU FCR %|24.7|||||TWO_SIDED|90.0|3.8|51.4|||||Miettinen and Nurminen method stratified by infection-site stratum|||51.4|3.8|
73825368|NCT02452047|147196835|OTHER|Difference in percentages|Difference in FMR %|0.0|||||TWO_SIDED|90.0|-20.8|36.6|||||Miettinen \& Nurminen method|||36.6|-20.8|
73825369|NCT02452047|147196836|OTHER|Difference in percentages|Difference in FMR %|0.0|||||TWO_SIDED|90.0|-20.8|36.6|||||Miettinen \& Nurminen method|||36.6|-20.8|
73825370|NCT02452047|147196837|OTHER|Difference in percentages|Difference in FMR %|-27.3|||||TWO_SIDED|90.0|-52.8|12.8|||||Miettinen \& Nurminen method|||12.8|-52.8|
73825371|NCT01249417|147196838|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.38||||0.0029|TWO_SIDED|95.0|-0.64|-0.13|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.||-0.13|-0.64|0.0029
73825372|NCT01249417|147196838|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.49||||0.0002|TWO_SIDED|95.0|-0.75|-0.23|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.||-0.23|-0.75|0.0002
73825373|NCT01249417|147196839|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|0.82|||<|0.0001|TWO_SIDED|95.0|0.5|1.14|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||1.14|0.50|<0.0001
73825374|NCT01249417|147196839|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|0.77|||<|0.0001|TWO_SIDED|95.0|0.45|1.1|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||1.10|0.45|<0.0001
73825375|NCT01249417|147196840|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|5.32||||0.0006|TWO_SIDED|95.0|2.31|8.32|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||8.32|2.31|0.0006
73825376|NCT01249417|147196840|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.65||||0.0031|TWO_SIDED|95.0|1.59|7.71|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||7.71|1.59|0.0031
73825377|NCT00917124|147196841|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared, Corrected|||"Hypothesis: intraoperative monitoring of cerebral oxigenation with INVOS system will improve cognitive outcome of patients undergoing CABG procedure.~Sample size was determined assuming 50% incidence of cognitive impairment after cardiac surgery and possibility of decreasing that incidence to 30% using cerebral oximetry. Based on 0.8 power to detect a significant difference (p=0.05), 90 patients were required for each study group."||||0.002
73825378|NCT01421498|147196872|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.24||||0.0007|TWO_SIDED|95.0|0.1|0.38|||t-test, 2 sided|||||0.38|0.10|0.0007
73825379|NCT01421498|147196873|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-0.02||||0.786|TWO_SIDED|95.0|-0.15|0.11|||t-test, 2 sided|||||0.11|-0.15|0.7860
73825380|NCT00243919|147196887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.831||||0.481|TWO_SIDED|95.0|0.497|1.391||The trial tested the superiority of LTP delivered early or late, compared to HEP, using a two-sided significance level of 0.05. The study-wide error rate was controlled by applying the Hochberg step-up procedure to the two primary comparisons.|Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Early-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression). Assuming that 30% of HEP participants would improve functional level of walking, we derived a sample size of 400 to detect a clinically relevant 20% effect size with 85% power, adjusting for an loss-to-follow-up rate of 15%.||1.391|0.497|0.481
73825381|NCT00243919|147196887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.192||||0.501|TWO_SIDED|95.0|0.715|1.985|||Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Late-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||1.985|0.715|0.501
73825382|NCT00243919|147196888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.242||95.0||||We did not formally conduct statistical inference on the timing effect because the first primary null hypotheses is accepted. The p-value provided is the smallest alpha level that one would claim significant difference between early- and late-LTP.|Regression, Linear||Even though there was no formal inference of timing effect, we still provided descriptive statistics for the 6-month and 12-month changes. In addition, paired t-tests were used to compare within-group improvements.|The second primary analysis assessed the timing effect and its interaction with initial severity of gait impairment on walking speed change from baseline to 1 year after stroke.||||0.242
73825383|NCT00243919|147196889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.01|TWO_SIDED|95.0|1.18|3.21|||Regression, Logistic|Pairwise comparisons were conducted: Early-LTP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between early-LTP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||3.21|1.18|0.010
73825384|NCT00243919|147196889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.007|TWO_SIDED|95.0|1.22|3.42|||Regression, Logistic|Pairwise comparisons were conducted: HEP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between HEP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||3.42|1.22|0.007
73825385|NCT00243919|147196890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||<|0.0001|TWO_SIDED|95.0|0.08|0.16||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p\<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between early-LTP and late-LTP.||0.16|0.08|<0.0001
73825386|NCT00243919|147196890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||<|0.0001|TWO_SIDED|95.0|0.05|0.14||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p\<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between HEP and late-LTP.||0.14|0.05|<.0001
73825387|NCT00243919|147196891|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Test differences across the three groups in change of 6 minute walking distance from baseline to 12-month post stroke.|ANOVA|||Primary 12 month analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.45
73825388|NCT00243919|147196891|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Test differences across the three groups in change of 6 minute walking distance from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<0.001
73825389|NCT00243919|147196892|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 12-month post stroke.||12 month primary outcome. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.||||0.10
73825390|NCT00243919|147196892|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 6-month post stroke.||6 month secondary analysis. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.||||0.04
73825391|NCT00243919|147196893|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.48
73825392|NCT00243919|147196893|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.06
73825393|NCT00243919|147196894|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.07
73825394|NCT00243919|147196894|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.03
73825395|NCT00243919|147196895|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.69
73825396|NCT00243919|147196895|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<.0001
73825397|NCT00243919|147196896|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 12-month post stroke.||12 month primary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.13
73825398|NCT00243919|147196896|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.04
73825399|NCT00243919|147196897|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.06
73825400|NCT00243919|147196897|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.001
73825401|NCT00243919|147196898|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.62
73825402|NCT00243919|147196898|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<0.001
73825403|NCT02318849|147196963|SUPERIORITY||Change in percentage|0.09||||0.009|TWO_SIDED||||||Mixed Models Analysis|The anaylsis was adjusted for student characteristics.||The null hypothesis was that the of number students who report being a donor (or talking to parents about organ donation) both before and after exposure to the intervention would be equivalent. A secondary null hypothesis would be that longer expsosures to the intervention over time would not increase the number who report becoming a donor at the final assessment.||||0.009
73825404|NCT02318849|147196964|SUPERIORITY||Change in percentage|0.0|||>|0.1|TWO_SIDED|||||Calculated|Mixed Models Analysis|||||||>0.10
73825405|NCT02389959|147196997|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-1.11||||0.111|TWO_SIDED|95.0|-2.47|0.26|||Regression, Linear|||Analysis between groups at month 1.||0.26|-2.47|0.111
73825406|NCT02389959|147196997|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-1.26||||0.131|TWO_SIDED|95.0|-2.9|0.38|||Regression, Linear|||Analysis between groups at month 2.||0.38|-2.9|0.131
73825407|NCT02389959|147196997|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-0.85||||0.332|TWO_SIDED|95.0|-2.57|0.88|||Regression, Linear|||Analysis between groups at month 4.||0.88|-2.57|0.332
73825408|NCT02389959|147196997|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-0.48||||0.597|TWO_SIDED|95.0|-2.25|1.3|||Regression, Linear|||Analysis between groups at month 6.||1.3|-2.25|0.597
73825409|NCT02389959|147196998|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|2.85||||0.191|TWO_SIDED|95.0|-1.44|7.13|||Regression, Linear|||Analysis between groups at month 1.||7.13|-1.44|0.191
73825410|NCT02389959|147196998|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|0.29||||0.914|TWO_SIDED|95.0|-5.02|5.61|||Regression, Linear|||Analysis between groups at month 2||5.61|-5.02|0.914
73825411|NCT02389959|147196998|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|1.55||||0.592|TWO_SIDED|95.0|-4.17|7.28|||Regression, Linear|||Analysis between groups at month 4.||7.28|-4.17|0.592
73825412|NCT02389959|147196998|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|3.1||||0.31|TWO_SIDED|95.0|-2.92|9.12|||Regression, Linear|||Analysis between groups at month 6||9.12|-2.92|0.31
73825413|NCT02389959|147196999|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-2.63||||0.366|TWO_SIDED|95.0|-8.38|3.11|||Regression, Linear|||Analysis between groups at month 1.||3.11|-8.38|0.366
73825414|NCT02389959|147196999|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|0.82||||0.816|TWO_SIDED|95.0|-6.12|7.76|||Regression, Linear|||Analysis between groups at month 2||7.76|-6.12|0.816
73825415|NCT02389959|147196999|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-4.3||||0.247|TWO_SIDED|95.0|-11.61|3.02|||Regression, Linear|||Analysis between groups at month 4.||3.02|-11.61|0.247
73825416|NCT02389959|147196999|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-8.18||||0.035|TWO_SIDED|95.0|-15.76|-0.6|||Regression, Linear|||Analysis between groups at month 6||-0.6|-15.76|0.035
73825417|NCT02389959|147197000|OTHER|||||||0.03|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at baseline.||||0.030
73825418|NCT02389959|147197000|OTHER|||||||0.719|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at month 2.||||0.719
73825419|NCT02389959|147197000|OTHER|||||||0.467|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at month 6.||||0.467
73825420|NCT02634073|147197001|SUPERIORITY_OR_OTHER||Ratio|0.855|||||TWO_SIDED|90.0|0.799|0.914|||ANCOVA||AUC (0-inf) comparison|||0.914|0.799|
73825421|NCT02634073|147197001|SUPERIORITY_OR_OTHER||Ratio|0.677|||||TWO_SIDED|90.0|0.635|0.721|||ANCOVA||AUC (0-inf) comparision|||0.721|0.635|
73825422|NCT02634073|147197001|SUPERIORITY_OR_OTHER||Ratio|0.637|||||TWO_SIDED|90.0|0.594|0.682|||ANCOVA||AUC (0-inf) comparision|||0.682|0.594|
73825423|NCT02634073|147197001|SUPERIORITY_OR_OTHER||Ratio|0.803|||||TWO_SIDED|90.0|0.747|0.864|||ANCOVA||AUC (0-24) comparision|||0.864|0.747|
73825424|NCT02634073|147197001|SUPERIORITY_OR_OTHER||Ratio|0.608|||||TWO_SIDED|90.0|0.566|0.655|||ANOVA||AUC (0-24) comparision|||0.655|0.566|
73825425|NCT02634073|147197001|SUPERIORITY_OR_OTHER||Ratio|0.557|||||TWO_SIDED|90.0|0.518|0.599|||ANCOVA||AUC (0-24) comparision|||0.599|0.518|
73825426|NCT02634073|147197001|SUPERIORITY_OR_OTHER||Ratio|0.819|||||TWO_SIDED|90.0|0.766|0.876|||ANCOVA||AUC (0-t) comparision|||0.876|0.766|
73825427|NCT02634073|147197001|SUPERIORITY_OR_OTHER||Ratio|0.636|||||TWO_SIDED|90.0|0.595|0.68|||ANCOVA||AUC (0-t) comparision|||0.680|0.595|
73825428|NCT02634073|147197001|SUPERIORITY_OR_OTHER||Ratio|0.585|||||TWO_SIDED|90.0|0.548|0.626|||ANCOVA||AUC (0-t) comparision|||0.626|0.548|
73825429|NCT02634073|147197002|SUPERIORITY_OR_OTHER||Ratio|0.993|||||TWO_SIDED|90.0|0.916|1.08|||ANCOVA||C24 comparison|||1.08|0.916|
73825430|NCT02634073|147197002|SUPERIORITY_OR_OTHER||Ratio|1.12|||||TWO_SIDED|90.0|1.03|1.21|||ANCOVA||C24 comparision|||1.21|1.03|
73825431|NCT02634073|147197002|SUPERIORITY_OR_OTHER||Ratio|1.09|||||TWO_SIDED|90.0|1.0|1.18|||ANCOVA||C24 comparision|||1.18|1.000|
73825432|NCT02634073|147197002|SUPERIORITY_OR_OTHER||Ratio|1.33|||||TWO_SIDED|90.0|1.13|1.56|||ANCOVA||Ct comparision|||1.56|1.13|
73825433|NCT02634073|147197002|SUPERIORITY_OR_OTHER||Ratio|1.46|||||TWO_SIDED|90.0|1.25|1.71|||ANCOVA||Ct comparision|||1.71|1.25|
73825434|NCT02634073|147197002|SUPERIORITY_OR_OTHER||Ratio|1.39|||||TWO_SIDED|90.0|1.18|1.63|||ANCOVA||Ct comparision|||1.63|1.18|
73825435|NCT02634073|147197002|SUPERIORITY_OR_OTHER||Ratio|0.724|||||TWO_SIDED|90.0|0.657|0.798|||ANCOVA||Cmax comparision|||0.798|0.657|
73825436|NCT02634073|147197002|SUPERIORITY_OR_OTHER||Ratio|0.479|||||TWO_SIDED|90.0|0.434|0.527|||ANCOVA||Cmax comparision|||0.527|0.434|
73825437|NCT02634073|147197002|SUPERIORITY_OR_OTHER||Ratio|0.454|||||TWO_SIDED|90.0|0.412|0.5|||ANCOVA||Cmax comparision|||0.500|0.412|
73825438|NCT02634073|147197003|SUPERIORITY_OR_OTHER||Ratio|1.37|||||TWO_SIDED|90.0|1.11|1.69|||ANCOVA|||||1.69|1.11|
73825439|NCT02634073|147197003|SUPERIORITY_OR_OTHER||Ratio|1.53|||||TWO_SIDED|90.0|1.25|1.88|||ANCOVA|||||1.88|1.25|
73825440|NCT02634073|147197003|SUPERIORITY_OR_OTHER||Ratio|1.29|||||TWO_SIDED|90.0|1.04|1.61|||ANCOVA|||||1.61|1.04|
73825441|NCT02634073|147197004|SUPERIORITY_OR_OTHER||Ratio|1.17|||||TWO_SIDED|90.0|1.094|1.251|||ANCOVA|||||1.251|1.094|
73825442|NCT02634073|147197004|SUPERIORITY_OR_OTHER||Ratio|1.478|||||TWO_SIDED|90.0|1.386|1.576|||ANCOVA|||||1.576|1.386|
73825443|NCT02634073|147197004|SUPERIORITY_OR_OTHER||Ratio|1.571|||||TWO_SIDED|90.0|1.466|1.684|||ANCOVA|||||1.684|1.466|
73825444|NCT02256696|147197021|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.1|TWO_SIDED|95.0|0.93|2.12|||Regression, Cox|adjusted for age and sex at birth.||modified intention to treat (mITT) analysis||2.12|0.93|0.10
73825445|NCT02256696|147197021|SUPERIORITY||Hazard Ratio (HR)|1.89||||0.003|TWO_SIDED|95.0|1.24|2.87|||Regression, Cox|adjusted for age and sex at birth.||mITT analysis||2.87|1.24|0.003
73825446|NCT02256696|147197021|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.09|TWO_SIDED|95.0|0.95|2.15|||Regression, Cox|adjusted for age and sex at birth||per protocol||2.15|0.95|0.09
73825447|NCT02256696|147197021|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.005|TWO_SIDED|95.0|1.21|2.89|||Regression, Cox|adjusted for age and sex at birth||per protocol||2.89|1.21|0.005
73825448|NCT02256696|147197024|SUPERIORITY||Hazard Ratio (HR)|1.61||||0.02|TWO_SIDED|95.0|1.07|2.44|||Regression, Cox|adjusted for age and sex at birth.||mITT analysis||2.44|1.07|0.02
73825449|NCT02256696|147197024|SUPERIORITY||Hazard Ratio (HR)|1.8||||0.006|TWO_SIDED|95.0|1.18|2.75|||Regression, Cox|adjusted for age and sex at birth||mITT analysis||2.75|1.18|0.006
73825450|NCT02256696|147197024|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.03|TWO_SIDED|95.0|1.05|2.42|||Regression, Cox|adjusted for age and sex at birth||per protocol analysis||2.42|1.05|0.03
73825451|NCT02256696|147197024|SUPERIORITY||Hazard Ratio (HR)|1.84||||0.007|TWO_SIDED|95.0|1.18|2.85|||Regression, Cox|adjusted for age and sex at birth||per protocol analysis||2.85|1.18|0.007
73825452|NCT01211145|147197068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.312|TWO_SIDED|95.0|0.75|2.5||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||2.50|0.75|.312
73825453|NCT01211145|147197068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.071|TWO_SIDED|95.0|0.95|3.26||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.26|0.95|.071
73825454|NCT01211145|147197068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.4|3.39||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||3.39|1.40|<.001
73825455|NCT01211145|147197069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.575|TWO_SIDED|95.0|0.7|1.91||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.91|0.70|.575
73825456|NCT01211145|147197069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.032|TWO_SIDED|95.0|1.06|3.31||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.31|1.06|.032
73825457|NCT01211145|147197069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.137|TWO_SIDED|95.0|0.91|1.95||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||1.95|0.91|.137
73825458|NCT01211145|147197070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.458|TWO_SIDED|95.0|0.74|1.96||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.96|0.74|.458
73825459|NCT01211145|147197070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.021|TWO_SIDED|95.0|1.09|3.03||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.03|1.09|.021
73825460|NCT01211145|147197070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.01|TWO_SIDED|95.0|1.12|2.32||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.32|1.12|.010
73825461|NCT01211145|147197071|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.753|TWO_SIDED|95.0|0.64|1.84||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.84|0.64|.753
73825462|NCT01211145|147197071|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.145|TWO_SIDED|95.0|0.86|2.79||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||2.79|0.86|.145
73825463|NCT01211145|147197071|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.127|TWO_SIDED|95.0|0.91|2.04||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.04|0.91|.127
73825464|NCT01211145|147197072|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.274|TWO_SIDED|95.0|0.79|2.32||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||2.32|0.79|.274
73825465|NCT01211145|147197072|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.67||||0.067|TWO_SIDED|95.0|0.96|2.91||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||2.91|0.96|.067
73825466|NCT01211145|147197072|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.127|TWO_SIDED|95.0|0.91|2.08||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.08|0.91|.127
73825467|NCT01211145|147197073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.153|TWO_SIDED|95.0|0.38|1.16||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.16|0.38|.153
73825468|NCT01211145|147197073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.087|TWO_SIDED|95.0|0.33|1.08||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||1.08|0.33|.087
73825469|NCT01211145|147197073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.004|TWO_SIDED|95.0|0.36|0.83||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||0.83|0.36|.004
73825470|NCT01431339|147197085|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|-1.5||||||95.0|-7.4|4.6|||||Confidence intervals were adjusted for fever at baseline|||4.6|-7.4|
73825471|NCT04536701|147197125|SUPERIORITY|||||||0.444|||||||t-test, 2 sided|||Total DASS score reported.||||0.444
73825472|NCT04536701|147197125|SUPERIORITY|||||||0.8378|||||||t-test, 2 sided|||Depressive Mood DASS score reported||||0.8378
73825473|NCT04536701|147197125|SUPERIORITY|||||||0.4087|||||||t-test, 2 sided|||Anxiety DASS score reported||||0.4087
73825474|NCT04536701|147197125|SUPERIORITY|||||||0.4124|||||||t-test, 2 sided|||Stress DASS score reported||||0.4124
73825475|NCT04536701|147197126|SUPERIORITY|||||||0.0508|||||||t-test, 2 sided|||Total RMBPC frequency reported||||0.0508
73825476|NCT04536701|147197126|SUPERIORITY|||||||0.026|||||||t-test, 2 sided|||Frequency of disruptive symptoms on RMBP reported||||0.026
73825477|NCT04536701|147197126|SUPERIORITY|||||||0.1861|||||||t-test, 2 sided|||Frequency of depressive symptoms on RMBPC reported||||0.1861
73825478|NCT04536701|147197126|SUPERIORITY|||||||0.9535|||||||t-test, 2 sided|||Frequency of memory symptoms on RMBPC reported||||0.9535
73825479|NCT04536701|147197126|SUPERIORITY|||||||0.0411|||||||t-test, 2 sided|||RMBPC reaction total is reported||||0.0411
73825480|NCT04536701|147197126|SUPERIORITY|||||||0.0058|||||||t-test, 2 sided|||RMBPC reaction disruptive symptoms is reported||||0.0058
73825481|NCT04536701|147197126|SUPERIORITY|||||||0.2527|||||||t-test, 2 sided|||RMBPC reaction depressive symptoms is reported||||0.2527
73825482|NCT04536701|147197126|SUPERIORITY|||||||0.3542|||||||t-test, 2 sided|||RMBPC reaction memory symptoms||||0.3542
73825483|NCT04536701|147197127|SUPERIORITY|||||||0.3857|||||||t-test, 2 sided|||||||0.3857
73825484|NCT04536701|147197128|SUPERIORITY|||||||0.7213|||||||t-test, 2 sided|||Five Facet Mindfulness Questionnaire (FFMQ) total reported||||0.7213
73825485|NCT04536701|147197128|SUPERIORITY|||||||0.6075|||||||t-test, 2 sided|||FFMQ Observing reported||||0.6075
73825486|NCT04536701|147197128|SUPERIORITY|||||||0.4136|||||||t-test, 2 sided|||FFMQ Describing reported||||0.4136
73825487|NCT04536701|147197128|SUPERIORITY|||||||0.8378|||||||t-test, 2 sided|||FFMQ Acting with Awareness reported||||0.8378
73825488|NCT04536701|147197128|SUPERIORITY|||||||0.7193|||||||t-test, 2 sided|||FFMQ Nonjudging reported||||0.7193
73825489|NCT04536701|147197128|SUPERIORITY|||||||0.4145|||||||t-test, 2 sided|||FFMQ Nonreactivity reported||||0.4145
73825490|NCT04536701|147197129|SUPERIORITY|||||||0.5368|||||||t-test, 2 sided|||||||0.5368
73825491|NCT04536701|147197130|SUPERIORITY|||||||0.2845|||||||t-test, 2 sided|||FAD Total reported||||0.2845
73825492|NCT04536701|147197130|SUPERIORITY|||||||0.1386|||||||t-test, 2 sided|||FAD Problem Solving is reported||||0.1386
73825493|NCT04536701|147197130|SUPERIORITY|||||||0.7551|||||||t-test, 2 sided|||FAD Communication is reported||||0.7551
73825494|NCT04536701|147197130|SUPERIORITY|||||||0.7213|||||||t-test, 2 sided|||FAD Roles is reported||||0.7213
73825495|NCT04536701|147197130|SUPERIORITY|||||||0.3233|||||||t-test, 2 sided|||FAD Affective Responsiveness is reported||||0.3233
73825496|NCT04536701|147197130|SUPERIORITY|||||||0.2832|||||||t-test, 2 sided|||FAD Affective Involvement is reported||||0.2832
73825497|NCT04536701|147197130|SUPERIORITY|||||||0.6831|||||||t-test, 2 sided|||FAD Behavior Control is reported||||0.6831
73825498|NCT04536701|147197130|SUPERIORITY|||||||0.6075|||||||t-test, 2 sided|||FAD General Functioning is reported||||0.6075
73825499|NCT00549549|147197132|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.74|-0.18|||ANCOVA|||This was the primary analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group and region as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||-0.18|-0.74|
73825500|NCT00549549|147197132|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.52|0.04|||ANCOVA|||||0.04|-0.52|
73825501|NCT00549549|147197132|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.84|||ANCOVA|||||0.84|0.29|
73825502|NCT00549549|147197132|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.05|0.6|||ANCOVA|||||0.60|0.05|
73825503|NCT00549549|147197132|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.17|0.39|||ANCOVA|||||0.39|-0.17|
73825504|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.29|0.14|||ANCOVA|||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||0.14|-0.29|
73825505|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.42|0.02|||ANCOVA|||Day 5 analysis||0.02|-0.42|
73825506|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.04|0.47|||ANCOVA|||Day 5 analysis||0.47|0.04|
73825507|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.04|0.39|||ANCOVA|||Day 5 analysis||0.39|-0.04|
73825508|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.16|0.27|||ANCOVA|||Day 5 analysis||0.27|-0.16|
73825509|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.26|0.16|||ANCOVA|||Day 9 analysis||0.16|-0.26|
73825510|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.4|0.03|||ANCOVA|||Day 9 analysis||0.03|-0.40|
73825511|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.11|0.32|||ANCOVA|||Day 9 analysis||0.32|-0.11|
73825512|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.16|0.27|||ANCOVA|||Day 9 analysis||0.27|-0.16|
73825513|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.3|0.13|||ANCOVA|||Day 9 analysis||0.13|-0.30|
73825514|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.33|0.1|||ANCOVA|||Day 14/early termination analysis||0.10|-0.33|
73825515|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.53|-0.11|||ANCOVA|||Day 14/early termination analysis||-0.11|-0.53|
73825516|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.05|0.37|||ANCOVA|||Day /early termination analysis||0.37|-0.05|
73825517|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.17|0.25|||ANCOVA|||Day 14/early termination analysis||0.25|-0.17|
73825518|NCT00549549|147197133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.38|0.05|||ANCOVA|||Day 14/early termination analysis||0.05|-0.38|
73825519|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.29|0.22|||ANCOVA|||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||0.22|-0.29|
73825520|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.35|0.16|||ANCOVA|||Day 5 analysis.||0.16|-0.35|
73825521|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.17|0.34|||ANCOVA|||Day 5 analysis.||0.34|-0.17|
73825522|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.2|0.3|||ANCOVA|||Day 5 analysis.||0.30|-0.20|
73825523|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.26|0.25|||ANCOVA|||Day 5 analysis.||0.25|-0.26|
73825524|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.11|||ANCOVA|||Day 9 analysis.||0.11|-0.36|
73825525|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.44|0.04|||ANCOVA|||Day 9 analysis.||0.04|-0.44|
73825526|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.01|0.46|||ANCOVA|||Day 9 analysis.||0.46|-0.01|
73825527|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.14|0.33|||ANCOVA|||Day 9 analysis.||0.33|-0.14|
73825528|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.22|0.26|||ANCOVA|||Day 9 analysis.||0.26|-0.22|
73825529|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.38|0.1|||ANCOVA|||Day 14/early termination analysis||0.10|-0.38|
73825530|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.52|-0.04|||ANCOVA|||Day 14/early termination analysis||-0.04|-0.52|
73825531|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.08|0.39|||ANCOVA|||Day 14/early termination analysis||0.39|-0.08|
73825532|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.22|0.26|||ANCOVA|||Day 14/early termination analysis||0.26|-0.22|
73825533|NCT00549549|147197134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.12|||ANCOVA|||Day 14/early termination analysis||0.12|-0.36|
73825534|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6402|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.6402
73825535|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9739|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.9739
73825536|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4581|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4581
73825537|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2962|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.2962
73825538|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4951|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4951
73825539|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4957|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4957
73825540|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8364|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.8364
73825541|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.6892
73825542|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4110
73825543|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5981|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.5981
73825544|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9317|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.9317
73825545|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0831|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0831
73825546|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5747|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.5747
73825547|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6204|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.6204
73825548|NCT00549549|147197135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2556|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analysis||||0.2556
73825549|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1444|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1444
73825550|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7532|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.7532
73825551|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4722|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4722
73825552|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3878|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.3878
73825553|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6717|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.6717
73825554|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3098|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.3098
73825555|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4356|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4356
73825556|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5703|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.5703
73825557|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4986|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4986
73825558|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7855|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.7855
73825559|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0169|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0169
73825560|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1353|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.1353
73825561|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.369|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.3690
73825562|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0787|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0787
73825563|NCT00549549|147197136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5687|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.5687
73825564|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular), region and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||-0.10|-0.60|
73825565|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.75|-0.25|||ANCOVA|||Day 1 analyses||-0.25|-0.75|
73825566|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.29|0.78|||ANCOVA|||Day 1 analyses||0.78|0.29|
73825567|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.06|0.44|||ANCOVA|||Day 1 analyses||0.44|-0.06|
73825568|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.21|0.28|||ANCOVA|||Day 1 analyses||0.28|-0.21|
73825569|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.52|0.04|||ANCOVA|||Day 2 analyses||0.04|-0.52|
73825570|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.74|-0.18|||ANCOVA|||Day 2 analyses||-0.18|-0.74|
73825571|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.84|||ANCOVA|||Day 2 analyses||0.84|0.29|
73825572|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.05|0.6|||ANCOVA|||Day 2 analyses||0.60|0.05|
73825573|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.17|0.39|||ANCOVA|||Day 2 analyses||0.39|-0.17|
73825574|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.53|0.03|||ANCOVA|||Day 3 analyses||0.03|-0.53|
73825575|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.83|-0.26|||ANCOVA|||Day 3 analyses||-0.26|-0.83|
73825576|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.32|0.88|||ANCOVA|||Day 3 analyses||0.88|0.32|
73825577|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.08|0.64|||ANCOVA|||Day 3 analyses||0.64|0.08|
73825578|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.22|0.34|||ANCOVA|||Day 3 analyses||0.34|-0.22|
73825579|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.56|0.0|||ANCOVA|||Day 4 analyses||-0.00|-0.56|
73825580|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.28|||ANCOVA|||Day 4 analyses||-0.28|-0.84|
73825581|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.35|0.9|||ANCOVA|||Day 4 analyses||0.90|0.35|
73825582|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.07|0.62|||ANCOVA|||Day 4 analyses||0.62|0.07|
73825583|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.21|0.34|||ANCOVA|||Day 4 analyses||0.34|-0.21|
73825584|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA|||Day 5 analyses||-0.07|-0.64|
73825585|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.94|-0.38|||ANCOVA|||Day 5 analyses||-0.38|-0.94|
73825586|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.37|0.93|||ANCOVA|||Day 5 analyses||0.93|0.37|
73825587|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.02|0.57|||ANCOVA|||Day 5 analyses||0.57|0.02|
73825588|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.29|0.27|||ANCOVA|||Day 5 analyses||0.27|-0.29|
73825589|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.65|-0.1|||ANCOVA|||Day 6 analyses||-0.10|-0.65|
73825590|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.29|||ANCOVA|||Day 6 analyses||-0.29|-0.84|
73825591|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.83|||ANCOVA|||Day 6 analyses||0.83|0.29|
73825592|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.08|0.46|||ANCOVA|||Day 6 analyses||0.46|-0.08|
73825593|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.28|0.26|||ANCOVA|||Day 6 analyses||0.26|-0.28|
73825594|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.61|-0.04|||ANCOVA|||Day 7 analyses||-0.04|-0.61|
73825595|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.92|-0.34|||ANCOVA|||Day 7 analyses||-0.34|-0.92|
73825596|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.21|0.78|||ANCOVA|||Day 7 analyses||0.78|0.21|
73825597|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.11|0.45|||ANCOVA|||Day 7 analyses||0.45|-0.11|
73825598|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.42|0.15|||ANCOVA|||Day 7 analyses||0.15|-0.42|
73825599|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.57|0.0|||ANCOVA|||Day 8 analyses||-0.00|-0.57|
73825600|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.27|||ANCOVA|||Day 8 analyses||-0.27|-0.84|
73825601|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.14|0.7|||ANCOVA|||Day 8 analyses||0.70|0.14|
73825602|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.15|0.41|||ANCOVA|||Day 8 analyses||0.41|-0.15|
73825603|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.42|0.14|||ANCOVA|||Day 8 analyses||0.14|-0.42|
73825604|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.61|-0.02|||ANCOVA|||Day 9 analyses||-0.02|-0.61|
73825605|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.82|-0.23|||ANCOVA|||Day 9 analyses||-0.23|-0.82|
73825606|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.18|0.76|||ANCOVA|||Day 9 analyses||0.76|0.18|
73825607|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.13|0.44|||ANCOVA|||Day 9 analyses||0.44|-0.13|
73825608|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.35|0.23|||ANCOVA|||Day 9 analyses||0.23|-0.35|
73825609|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.59|0.01|||ANCOVA|||Day 10 analyses||0.01|-0.59|
73825610|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.76|-0.16|||ANCOVA|||Day 10 analyses||-0.16|-0.76|
73825611|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.1|0.69|||ANCOVA|||Day 10 analyses||0.69|0.10|
73825612|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.18|0.41|||ANCOVA|||Day 10 analyses||0.41|-0.18|
73825613|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.36|0.23|||ANCOVA|||Day 10 analyses||0.23|-0.36|
73825614|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.56|0.05|||ANCOVA|||Day 11 analyses||0.05|-0.56|
73825615|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.77|-0.17|||ANCOVA|||Day 11 analyses||-0.17|-0.77|
73825616|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.1|0.69|||ANCOVA|||Day 11 analyses||0.69|0.10|
73825617|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.16|0.44|||ANCOVA|||Day 11 analyses||0.44|-0.16|
73825618|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.37|0.23|||ANCOVA|||Day 11 analyses||0.23|-0.37|
73825619|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||Day 12 analyses||0.09|-0.53|
73825620|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.77|-0.15|||ANCOVA|||Day 12 analyses||-0.15|-0.77|
73825621|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.04|0.57|||ANCOVA|||Day 12 analyses||0.57|-0.04|
73825622|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.25|0.36|||ANCOVA|||Day 12 analyses||0.36|-0.25|
73825623|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.5|0.11|||ANCOVA|||Day 12 analyses||0.11|-0.50|
73825624|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.56|0.07|||ANCOVA|||Day 13/Early Termination analyses||0.07|-0.56|
73825625|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.81|-0.19|||ANCOVA|||Day 13/Early Termination analyses||-0.19|-0.81|
73825626|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.1|0.51|||ANCOVA|||Day 13/Early Termination analyses||0.51|-0.10|
73825627|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.35|0.26|||ANCOVA|||Day 13/Early Termination analyses||0.26|-0.35|
73825628|NCT00549549|147197137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.6|0.01|||ANCOVA|||Day 13/Early Termination analyses||0.01|-0.60|
73825629|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.28|0.14|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.14|-0.28|
73825630|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.39|0.03|||ANCOVA|||Day 1, 2 hours postdose||0.03|-0.39|
73825631|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.11|0.52|||ANCOVA|||Day 1, 2 hours postdose||0.52|0.11|
73825632|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.04|0.45|||ANCOVA|||Day 1, 2 hours postdose||0.45|0.04|
73825633|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.08|0.34|||ANCOVA|||Day 1, 2 hours postdose||0.34|-0.08|
73825634|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.37|0.08|||ANCOVA|||Day 1, 4 hours postdose||0.08|-0.37|
73825635|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.48|-0.03|||ANCOVA|||Day 1, 4 hours postdose||-0.03|-0.48|
73825636|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.14|0.58|||ANCOVA|||Day 1, 4 hours postdose||0.58|0.14|
73825637|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.0|0.44|||ANCOVA|||Day 1, 4 hours postdose||0.44|0.00|
73825638|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.11|0.34|||ANCOVA|||Day 1, 4 hours postdose||0.34|-0.11|
73825639|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.32|0.17|||ANCOVA|||Day 1, 8 hours postdose||0.17|-0.32|
73825640|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.56|-0.06|||ANCOVA|||Day 1, 8 hours postdose||-0.06|-0.56|
73825641|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.18|0.67|||ANCOVA|||Day 1, 8 hours postdose||0.67|0.18|
73825642|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.11|0.59|||ANCOVA|||Day 1, 8 hours postdose||0.59|0.11|
73825643|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.13|0.36|||ANCOVA|||Day 1, 8 hours postdose||0.36|-0.13|
73825644|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.42|0.1|||ANCOVA|||Day 1, 12 hours postdose||0.10|-0.42|
73825645|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.63|-0.11|||ANCOVA|||Day 1, 12 hours postdose||-0.11|-0.63|
73825646|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.19|0.7|||ANCOVA|||Day 1, 12 hours postdose||0.70|0.19|
73825647|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.03|0.55|||ANCOVA|||Day 1, 12 hours postdose||0.55|0.03|
73825648|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.18|0.34|||ANCOVA|||Day 1, 12 hours postdose||0.34|-0.18|
73825649|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.46|0.07|||ANCOVA|||Day 2, 0 hours postdose||0.07|-0.46|
73825650|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.57|-0.04|||ANCOVA|||Day 2, 0 hours postdose||-0.04|-0.57|
73825651|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.16|0.68|||ANCOVA|||Day 2, 0 hours postdose||0.68|0.16|
73825652|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.04|0.49|||ANCOVA|||Day 2, 0 hours postdose||0.49|-0.04|
73825653|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.15|0.38|||ANCOVA|||Day 2, 0 hours postdose||0.38|-0.15|
73825654|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.4|0.14|||ANCOVA|||Day 2, 8 hours postdose||0.14|-0.40|
73825655|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.59|-0.05|||ANCOVA|||Day 2, 8 hours postdose||-0.05|-0.59|
73825656|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.2|0.74|||ANCOVA|||Day 2, 8 hours postdose||0.74|0.20|
73825657|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.08|0.61|||ANCOVA|||Day 2, 8 hours postdose||0.61|0.08|
73825658|NCT00549549|147197138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.11|0.42|||ANCOVA|||Day 2, 8 hours postdose||0.42|-0.11|
73825659|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.09|0.27|||ANCOVA|||8 hour postdose analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.27|-0.09|
73825660|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.04|0.4|||ANCOVA|||8 hour postdose analysis||0.40|0.04|
73825661|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.5|-0.14|||ANCOVA|||8 hour postdose analysis||-0.14|-0.50|
73825662|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.41|-0.05|||ANCOVA|||8 hour postdose analysis||-0.05|-0.41|
73825663|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.28|0.08|||ANCOVA|||8 hour postdose analysis||0.08|-0.28|
73825664|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.1|0.29|||ANCOVA|||12 hour postdose analysis||0.29|-0.10|
73825665|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.06|0.45|||ANCOVA|||12 hour postdose analysis||0.45|0.06|
73825666|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.55|-0.16|||ANCOVA|||12 hour postdose analysis||-0.16|-0.55|
73825667|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.45|-0.07|||ANCOVA|||12 hour postdose analysis||-0.07|-0.45|
73825668|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.29|0.09|||ANCOVA|||12 hour postdose analysis||0.09|-0.29|
73825669|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.08|0.35|||ANCOVA|||24 hour postdose analysis||0.35|-0.08|
73825670|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.08|0.51|||ANCOVA|||24 hour postdose analysis||0.51|0.08|
73825671|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.61|-0.18|||ANCOVA|||24 hour postdose analysis||-0.18|-0.61|
73825672|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.47|-0.05|||ANCOVA|||24 hour postdose analysis||-0.05|-0.47|
73825673|NCT00549549|147197139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.32|0.11|||ANCOVA|||24 hour postdose analysis||0.11|-0.32|
73825674|NCT00549549|147197140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0459|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||||0.0459
73825675|NCT00549549|147197140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0017
73825676|NCT00549549|147197140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0001
73825677|NCT00549549|147197140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0410
73825678|NCT00549549|147197140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5592|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.5592
73825679|NCT00549549|147197140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0277|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0277
73825680|NCT00549549|147197140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0018
73825681|NCT00549549|147197140|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||<.0001
73825682|NCT00549549|147197140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0394
73825683|NCT00549549|147197140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4603|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.4603
73825684|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5528|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5528
73825685|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1779
73825686|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1754|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1754
73825687|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3384|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.3384
73825688|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5005
73825689|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0845|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0845
73825690|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0213|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0213
73825691|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1231|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1231
73825692|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6636|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.6636
73825693|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5378|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5378
73825694|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0818
73825695|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0317|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0317
73825696|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1592|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1592
73825697|NCT00549549|147197143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7956|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.7956
73825698|NCT00549549|147197144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.17|0.31|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.31|-0.17|
73825699|NCT00549549|147197144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.02|0.46|||ANCOVA|||||0.46|-0.02|
73825700|NCT00549549|147197144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||||-0.02|-0.50|
73825701|NCT00549549|147197144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.43|0.05|||ANCOVA|||||0.05|-0.43|
73825702|NCT00549549|147197144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.28|0.19|||ANCOVA|||||0.19|-0.28|
73825703|NCT00549549|147197145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.3173
73825704|NCT00549549|147197146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4724|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.4724
73825705|NCT00549549|147197146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7316|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.7316
73825706|NCT00549549|147197146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7316|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.7316
73825707|NCT02227784|147197151|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.48|||<|0.001|TWO_SIDED|95.0|-44.4|-23.3|||ANCOVA|||||-23.3|-44.4|<0.001
73825708|NCT02227784|147197151|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-27.24|||<|0.001|TWO_SIDED|95.0|-36.6|-18.5|||ANCOVA|||||-18.5|-36.6|<0.001
73825709|NCT02227784|147197151|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.14||||0.045|TWO_SIDED|95.0|-12.2|-0.22|||ANCOVA|||||-0.22|-12.2|0.045
73825710|NCT02227784|147197152|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|125.28|||<|0.001|TWO_SIDED|95.0|117.1|133.6|||Mixed Models Analysis|||||133.6|117.1|<0.001
73825711|NCT02227784|147197152|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|131.48|||<|0.001|TWO_SIDED|95.0|123.5|139.5|||Mixed Models Analysis|||||139.5|123.5|<0.001
73825712|NCT02227784|147197152|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|127.57|||<|0.001|TWO_SIDED|95.0|120.1|135.0|||Mixed Models Analysis|||||135.0|120.1|<0.001
73825713|NCT02227784|147197153|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|46.35|||<|0.001|TWO_SIDED|95.0|40.79|51.98|||ANCOVA|||||51.98|40.79|<0.001
73825714|NCT02227784|147197153|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|52.22|||<|0.001|TWO_SIDED|95.0|47.12|57.33|||ANCOVA|||||57.33|47.12|<0.001
73825715|NCT02227784|147197153|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|48.44|||<|0.001|TWO_SIDED|95.0|43.82|52.86|||ANCOVA|||||52.86|43.82|<0.001
73825716|NCT02227784|147197154|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-26.47|||<|0.001|TWO_SIDED|95.0|-33.4|-20.0|||Mixed Models Analysis|||||-20.0|-33.4|<0.001
73825717|NCT02227784|147197154|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-22.02|||<|0.001|TWO_SIDED|95.0|-28.4|-15.9|||Mixed Models Analysis|||||-15.9|-28.4|<0.001
73825718|NCT02227784|147197154|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-7.05|||<|0.001|TWO_SIDED|95.0|-11.5|-2.68|||Mixed Models Analysis|||||-2.68|-11.5|<0.001
73825719|NCT02227784|147197155|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-23.16|||<|0.001|TWO_SIDED|95.0|-30.0|-16.5|||ANCOVA|||||-16.5|-30.00|<0.001
73825720|NCT02227784|147197155|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-16.42|||<|0.001|TWO_SIDED|95.0|-22.3|-10.6|||ANCOVA|||||-10.6|-22.3|<0.001
73825721|NCT02227784|147197155|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-4.11||||0.062|TWO_SIDED|95.0|-8.47|0.15|||ANCOVA|||||0.15|-8.47|0.062
73825722|NCT02227784|147197156|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|38.05|||<|0.001|TWO_SIDED|95.0|30.17|45.88|||ANCOVA|||||45.88|30.17|<0.001
73825723|NCT02227784|147197156|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|42.12|||<|0.001|TWO_SIDED|95.0|34.29|49.76|||ANCOVA|||||49.76|34.29|<0.001
73825724|NCT02227784|147197156|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|39.64|||<|0.001|TWO_SIDED|95.0|33.2|46.08|||ANCOVA|||||46.08|33.20|<0.001
73825725|NCT02227784|147197157|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.18|||<|0.001|TWO_SIDED|95.0|-44.9|-22.3|||ANCOVA|||||-22.3|-44.9|<0.001
73825726|NCT02227784|147197157|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-32.63|||<|0.001|TWO_SIDED|95.0|-44.0|-21.8|||ANCOVA|||||-21.8|-44.0|<0.001
73825727|NCT02227784|147197157|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-42.15|||<|0.001|TWO_SIDED|95.0|-50.9|-33.4|||ANCOVA|||||-33.4|-50.9|<0.001
73825728|NCT02688933|147197174|SUPERIORITY||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|1.15||0.8494|TWO_SIDED|||||Threshold for significance at 0.05 level.|Generalized linear model|Generalized linear model with identity link||Analysis was performed using generalized linear model with identity link, had percentage of time glucose concentration within target range 70-180 mg/dL as dependent variable, treatment group as an independent variable, adjusting variables including baseline characteristics: duration of diabetes, baseline BMI, age, and randomization strata (HbA1c at screening \[\<8.0% vs ≥8.0%\], frequency of Lantus injection at screening, current CGM use \[yes/no\], and mealtime insulin titration algorithm).||||0.8494
73825729|NCT00248651|147197182|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|||Overall treatment effect from logistic regression model incorporating balancing factors. A p-value of \<0.05 was considered statistically significant.||||0.05
73825730|NCT00248651|147197185|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||Comparison between antidepressant arms and placebo for overall quality of life. A p-value of \<0.05 was considered statistically significant.||||0.02
73825731|NCT00248651|147197185|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Eat/Drink subscale. A p-value of \<0.05 was considered statistically significant.||||0.06
73825732|NCT00248651|147197185|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Interference subscale. A p-value of \<0.05 was considered statistically significant.||||0.06
73825733|NCT00248651|147197185|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Sleep Disturbance subscale. A p-value of \<0.05 was considered statistically significant.||||0.01
73825734|NCT00248651|147197185|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Work/Study subscale. A p-value of \<0.05 was considered statistically significant.||||0.04
73825735|NCT01275144|147197186|SUPERIORITY_OR_OTHER||Ratio of geometric least square mean|0.897|||||TWO_SIDED|90.0|0.86|0.94|||||Ratio of LY2216684 to Placebo|||0.94|0.86|
73825736|NCT01275144|147197187|SUPERIORITY_OR_OTHER||median of paired differences|0.5||||0.0021|TWO_SIDED|90.0|0.5|1.0|||Wilcoxon signed rank test||Ratio of LY2216684 to Placebo|||1.00|0.50|0.0021
73825737|NCT01275144|147197188|SUPERIORITY_OR_OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|1.01|1.08|||||Ratio of LY2216684 to Placebo|||1.08|1.01|
73825738|NCT05607576|147197211|OTHER|Clarke error grid analyses (EGA) were performed to compare CGM values to glucometer glucose values blood glucose readings (mg/dL) were grouped based on radiation exposure (\>0-500 µGy and \>500 µGy). A p-value \<0.05 was considered statistically significant.|||||<|0.05|||||||Mixed Models Analysis|Generalized linear mixed models with random effects were used to assess absolute differences in BG mg/dL by cumulative scatter||||||<0.05
73825739|NCT05607576|147197212|OTHER|Clarke error grid analyses (EGA) were performed to compare CGM values to glucometer glucose values. A p-value \<0.05 was considered statistically significant.|||||<|0.05|||||||Mixed Models Analysis|Generalized linear mixed models with random effects over time were used to assess absolute differences in BG mg/dL by time||||||<0.05
73825740|NCT01091246|147197213|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5.|Ratio of geometric mean|1.07|||||TWO_SIDED|95.0|0.98|1.16|||Bootstrapping|||A/H1N1: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H1N1 strain||1.16|0.98|
73825741|NCT01091246|147197213|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric means|1.04|||||TWO_SIDED|95.0|0.94|1.14|||Bootstrapping|||A/H3N2: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H3N2 strain||1.14|0.94|
73825742|NCT01091246|147197213|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.21|||||TWO_SIDED|95.0|1.07|1.37||||||B/Yamagata: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata) / (Q/LAIV) for B/Yamagata strain||1.37|1.07|
73825743|NCT01091246|147197213|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% confidence intervals were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.05|||||TWO_SIDED|95.0|0.93|1.18||||||B/Victoria: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Victoria) / (Q/LAIV) for B/Victoria strain||1.18|0.93|
73825744|NCT02175225|147197251|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.006|||||ONE_SIDED|90.0||0.068|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.068||
73825745|NCT02175225|147197252|OTHER||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.57|1.16||||||||1.16|0.57|
73825746|NCT02175225|147197253|OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.57|1.56||||||||1.56|0.57|
73825747|NCT02175225|147197254|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than13% in favor of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.062|||||ONE_SIDED|90.0||0.121|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference\[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.121||
73825748|NCT02175225|147197255|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.086|||||ONE_SIDED|90.0||0.156|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.156||
73825749|NCT02175225|147197256|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 13% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|-0.018|||||ONE_SIDED|90.0||0.029|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 13% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.029||
73825750|NCT02175225|147197257|OTHER|||||||0.83||||||The p value reflects the significance of the interaction term between treatment and onset to treatment time.|Regression, Logistic|||||||0.83
73825751|NCT02175225|147197258|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.72|1.67|||||The estimation parameter is the adjusted common odds ratio.|||1.67|0.72|
73825752|NCT02175225|147197259|OTHER||Odds Ratio, log|1.26|||||TWO_SIDED|95.0|0.82|1.93||||||||1.93|0.82|
73825753|NCT02175225|147197262|OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.0|14.97|||||Confidence interval is exact (rather than asymptotic) due to small number of events.|||14.97|0.0|
73825754|NCT02175225|147197263|OTHER||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.51|1.54|||||Confidence interval constructed only for all cause owing to small number of events caused by acute respiratory distress syndrome.|||1.54|0.51|
73825755|NCT02175225|147197264|OTHER||Risk Ratio (RR)|1.84|||||TWO_SIDED|95.0|0.63|5.35||||||||5.35|0.63|
73825756|NCT02668640|147197265|OTHER||||||=|0.0002|||||||Wilcoxon signed-rank test|||||||=0.0002
73825757|NCT02668640|147197266|OTHER||||||=|0.0006|||||||Wilcoxon signed-rank test|||||||=0.0006
73825758|NCT02668640|147197267|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 12||||<0.0001
73825759|NCT02668640|147197267|OTHER||||||=|0.1233|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 12||||=0.1233
73825760|NCT02668640|147197267|OTHER||||||<|0.001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 24||||<0.001
73825761|NCT02668640|147197267|OTHER||||||=|0.001|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 24||||=0.001
73825762|NCT02668640|147197268|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 12||||<0.0001
73825763|NCT02668640|147197268|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 24||||<0.0001
73825764|NCT02668640|147197269|OTHER||||||=|0.0137|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Overall Work Impairment Score at Week 12||||=0.0137
73825765|NCT02668640|147197269|OTHER||||||=|0.0607|||||||Wilcoxon signed-rank test|||Median Change from Baseline in Overall Work Impairment Score at Week 24||||=0.0607
73825766|NCT02668640|147197270|OTHER||||||=|0.0026|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 12||||=0.0026
73825767|NCT02668640|147197270|OTHER||||||=|0.0001|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 24||||=0.0001
73825768|NCT01121263|147197282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.063||||0.8||95.0|0.666|1.697|||Regression, Cox|The Cox proportional hazards regression model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|The Cox model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|This applies to any MACCE||1.697|0.666|0.80
73825769|NCT01121263|147197283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.53||95.0|0.556|1.355|||Regression, Cox||The Cox proportional hazards regression model was weighted by the propensity score to account for the difference in baseline risk between groups.|This applies to any MACCE||1.355|0.556|0.53
73825770|NCT01386606|147197298|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||P-value of treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||||0.056
73825771|NCT01386606|147197298|SUPERIORITY_OR_OTHER||Regression Coefficient|-45.77||||0.436|TWO_SIDED|95.0|-143.5|51.98||P-value for Androxal 25 mg treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||51.98|-143.5|0.436
73825772|NCT01386606|147197298|SUPERIORITY_OR_OTHER||Regression Coefficient|-110.9||||0.068|TWO_SIDED|95.0|-210.6|-11.23||P-value for Androxal 12.5 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||-11.23|-210.6|0.068
73825773|NCT01386606|147197298|SUPERIORITY_OR_OTHER||Regression Coefficient|-148.5||||0.011|TWO_SIDED|95.0|-242.9|-54.05||P-value for Androxal 6.25 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||-54.05|-242.9|0.011
73825774|NCT01386606|147197298|SUPERIORITY_OR_OTHER||Regression Coefficient|0.58|||<|0.001|TWO_SIDED|95.0|0.37|0.79||P-value for morning total testosterone (adjusted for treatment effect if treatment group is significant).|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||0.79|0.37|<0.001
73825775|NCT01386606|147197299|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 2. Modeling change from baseline by treatment group.||||<0.001
73825776|NCT01386606|147197299|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 4. Modeling change from baseline by treatment group.||||<0.001
73825777|NCT01386606|147197299|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 6. Modeling change from baseline by treatment group.||||<0.001
73825778|NCT01386606|147197300|SUPERIORITY_OR_OTHER||Pearson Correlation|0.90993|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cavg at Week 6.||||<0.0001
73825779|NCT01386606|147197300|SUPERIORITY_OR_OTHER||Pearson Correlation|0.86541|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmin at Week 6.||||<0.0001
73825780|NCT01386606|147197300|SUPERIORITY_OR_OTHER||Pearson Correlation|0.89643|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmax at Week 6.||||<0.0001
73825781|NCT01386606|147197302|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 2. Modeling change from baseline by treatment group.||||<0.001
73825782|NCT01386606|147197302|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 4. Modeling change from baseline by treatment group.||||<0.001
73825783|NCT01386606|147197302|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 6. Modeling change from baseline by treatment group.||||<0.001
73825784|NCT01965327|147197331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|TWO_SIDED||||||t-test, 2 sided|Missing data were imputed by last observation carried forward.||||||0.027
73825785|NCT01965327|147197332|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED||||||t-test, 2 sided|||||||0.0078
73825786|NCT03964207|147197340|SUPERIORITY||Difference of LSmeans|-5.28||||0.007|TWO_SIDED|95.0|-9.07|-1.48|||Mixed-effects Model||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||-1.48|-9.07|0.007
73825787|NCT03964207|147197341|SUPERIORITY||Difference of LSmeans|-4.14||||0.024|TWO_SIDED|95.0|-7.72|-0.56|||Mixed Models Analysis||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect||-0.56|-7.72|0.024
73825788|NCT03964207|147197342|SUPERIORITY||Difference rate (%)|13.0||||0.249|||||||Chi-square test||The Difference rate was calculated as: value from the test treatment group - value from the comparator treatment group.|Chi-squared test was used to analyze proportion of patients indicating preference in the Patient satisfaction and preference questionnaire (PASAPQ) at week 8. All participants have used both treatments at this point: Handihaler (4 weeks) and Respimat (4 weeks).||||0.249
73825789|NCT03964207|147197343|SUPERIORITY||Difference of LSmeans|-4.72||||0.057|TWO_SIDED|95.0|-9.59|0.15|||The mixed model for repeated measures||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||0.15|-9.59|0.057
73825790|NCT03964207|147197344|SUPERIORITY||Difference of LSmeans|-4.38||||0.347|TWO_SIDED|95.0|-13.63|4.86|||Mixed Models Analysis||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||4.86|-13.63|0.347
73825791|NCT01294423|147197345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0853|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)||-0.18|-0.52|<0.0001
73825792|NCT01294423|147197345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.0851|<|0.0001|TWO_SIDED|95.0|-0.56|-0.23||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)||-0.23|-0.56|<0.0001
73825793|NCT01294423|147197346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|STANDARD_ERROR_OF_MEAN|2.902|<|0.0001|TWO_SIDED|95.0|-20.1|-8.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-8.7|-20.1|<0.0001
73825794|NCT01294423|147197346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|2.892|<|0.0001|TWO_SIDED|95.0|-25.2|-13.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-13.8|-25.2|<0.0001
73825795|NCT01294423|147197347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.3533||0.0003|TWO_SIDED|95.0|-1.98|-0.59||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.59|-1.98|0.0003
73825796|NCT01294423|147197347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.354||0.0001|TWO_SIDED|95.0|-2.08|-0.69||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.69|-2.08|0.0001
73825797|NCT02026141|147197372|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
73825798|NCT02059239|147197400|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|88.9|||||TWO_SIDED|95.0|65.3|98.6||||||||98.6|65.3|
73825799|NCT02059239|147197400|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|81.3|||||TWO_SIDED|95.0|54.4|95.9||||||||95.9|54.4|
73825800|NCT02059239|147197401|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
73825801|NCT02059239|147197401|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|75.3|100.0||||||||100.0|75.3|
73825802|NCT02059239|147197402|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
73825803|NCT02059239|147197402|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|92.3|||||TWO_SIDED|95.0|64.0|99.8||||||||99.8|64.0|
73825804|NCT02059239|147197403|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
73825805|NCT02059239|147197403|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|84.6|||||TWO_SIDED|95.0|54.6|98.1||||||||98.1|54.6|
73825806|NCT02059239|147197404|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
73825807|NCT02059239|147197404|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|46.2|||||TWO_SIDED|95.0|19.2|74.9||||||||74.9|19.2|
73825808|NCT02059239|147197405|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|0.0|||||TWO_SIDED|95.0|0.0|20.6||||||||20.6|0.0|
73825809|NCT02059239|147197405|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|15.4|||||TWO_SIDED|95.0|1.9|45.4||||||||45.4|1.9|
73825810|NCT02059239|147197406|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|66.7|||||TWO_SIDED|95.0|41.0|86.7||||||||86.7|41.0|
73825811|NCT02059239|147197406|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|43.8|||||TWO_SIDED|95.0|19.8|70.1||||||||70.1|19.8|
73825812|NCT02059239|147197407|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|87.5|||||TWO_SIDED|95.0|61.7|98.4||||||||98.4|61.7|
73825813|NCT02059239|147197407|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|76.9|||||TWO_SIDED|95.0|46.2|95.0||||||||95.0|46.2|
73825814|NCT02059239|147197408|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|81.3|||||TWO_SIDED|95.0|54.4|96.0||||||||96.0|54.4|
73825815|NCT02059239|147197408|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|30.8|||||TWO_SIDED|95.0|9.1|61.4||||||||61.4|9.1|
73825816|NCT02059239|147197409|OTHER|Median PFS in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Median (95% CI)|8.0|||||TWO_SIDED|95.0|5.0|25.0||||||||25|5|
73825817|NCT02219685|147197410|SUPERIORITY_OR_OTHER|||||||0.58||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.58
73825818|NCT02219685|147197410|SUPERIORITY_OR_OTHER|||||||0.48||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.48
73825819|NCT02219685|147197410|SUPERIORITY_OR_OTHER|||||||0.96||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.96
73825820|NCT02219685|147197411|SUPERIORITY_OR_OTHER|||||||0.54||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.54
73825821|NCT02219685|147197411|SUPERIORITY_OR_OTHER|||||||0.57||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.57
73825822|NCT02219685|147197411|SUPERIORITY_OR_OTHER|||||||0.63||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.63
73825823|NCT02219685|147197412|SUPERIORITY_OR_OTHER|||||||0.7||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.70
73825824|NCT02219685|147197412|SUPERIORITY_OR_OTHER|||||||0.21||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.21
73825825|NCT02219685|147197412|SUPERIORITY_OR_OTHER|||||||0.59||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.59
73825826|NCT02219685|147197413|SUPERIORITY_OR_OTHER|||||||0.0795||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.0795
73825827|NCT02219685|147197414|SUPERIORITY_OR_OTHER|||||||0.7007||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.7007
73825828|NCT02219685|147197415|SUPERIORITY_OR_OTHER|||||||0.2677||||||The p-value was ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.2677
73825829|NCT02219685|147197416|SUPERIORITY_OR_OTHER|||||||0.987||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.9870
73825830|NCT02219685|147197417|SUPERIORITY_OR_OTHER|||||||0.3388||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.3388
73825831|NCT04622969|147197472|SUPERIORITY||Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|5.157|<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
73825832|NCT04622969|147197474|SUPERIORITY||Mean Difference (Net)|7.12|STANDARD_ERROR_OF_MEAN|12.05|=|0.56|TWO_SIDED||||||Mixed Models Analysis|||||||=0.56
73825833|NCT04622969|147197478|SUPERIORITY||Mean Difference (Net)|0.0015|STANDARD_ERROR_OF_MEAN|0.145|=|0.99|TWO_SIDED||||||Mixed Models Analysis|||||||=0.99
73825834|NCT04622969|147197480|SUPERIORITY||Mean Difference (Net)|-0.264|STANDARD_ERROR_OF_MEAN|0.121|<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
73825835|NCT04622969|147197482|SUPERIORITY||Mean Difference (Net)|-5.573|STANDARD_ERROR_OF_MEAN|1.802|<|0.01|TWO_SIDED||||||ANCOVA|||||||<.01
73825836|NCT04622969|147197484|SUPERIORITY||Mean Difference (Net)|3.509|STANDARD_ERROR_OF_MEAN|1.842|=|0.062|TWO_SIDED||||||ANCOVA|||||||=.062
73825837|NCT04622969|147197484|SUPERIORITY||Mean Difference (Net)|0.047|STANDARD_ERROR_OF_MEAN|0.17|=|0.78|TWO_SIDED||||||Mixed Models Analysis|||||||=0.78
73825838|NCT05616013|147197500|SUPERIORITY||LS Mean Change difference|-14.5|||<|0.001|TWO_SIDED|95.0|-18.0|-11.0|||ANCOVA|||Bima 30mg/kg + Sema 2.4mg vs Placebo||-11.0|-18.0|<0.001
73825839|NCT05616013|147197500|SUPERIORITY||LS Mean Change difference|-10.5|||<|0.001|TWO_SIDED|95.0|-14.0|-7.09|||ANCOVA|||Bima 30mg/kg + Sema 1.0mg vs Placebo||-7.09|-14.0|<0.001
73825840|NCT05616013|147197500|SUPERIORITY||LS Mean Change difference|-11.0|||<|0.001|TWO_SIDED|95.0|-14.4|-7.55|||ANCOVA|||Bima 10mg/kg + Sema 2.4mg vs Placebo||-7.55|-14.4|<0.001
73825841|NCT05616013|147197500|SUPERIORITY||LS Mean Change difference|-9.41|||<|0.001|TWO_SIDED|95.0|-12.9|-5.93|||ANCOVA|||Bima 10mg/kg + Sema 1.0mg vs Placebo||-5.93|-12.9|<.001
73825842|NCT05616013|147197500|SUPERIORITY||LS Mean Change difference|-10.9|||<|0.001|TWO_SIDED|95.0|-14.4|-7.46|||ANCOVA|||Sema 2.4mg vs Placebo||-7.46|-14.4|<0.001
73825843|NCT05616013|147197500|SUPERIORITY||LS Mean Change difference|-6.45|||<|0.001|TWO_SIDED|95.0|-9.96|-2.94|||ANCOVA|||Sema 1.0mg vs Placebo||-2.94|-9.96|<0.001
73825844|NCT05616013|147197500|SUPERIORITY||LS Mean Change difference|-5.94|||<|0.001|TWO_SIDED|95.0|-9.47|-2.41|||ANCOVA|||Bima 30mg/kg vs Placebo||-2.41|-9.47|<0.001
73825845|NCT05616013|147197500|SUPERIORITY||LS Mean Change difference|-2.68||||0.133|TWO_SIDED|95.0|-6.18|0.82|||ANCOVA|||Bima 10mg/kg vs Placebo||0.82|-6.18|0.133
73825846|NCT05116202|147197541|SUPERIORITY||Difference in pRR|2.73|||||TWO_SIDED|95.0|-22.25|27.7||||||||27.70|-22.25|
73825847|NCT05116202|147197541|SUPERIORITY||Difference in pRR|-32.27|||||TWO_SIDED|95.0|-65.01|0.46||||||||0.46|-65.01|
73825848|NCT05116202|147197541|SUPERIORITY||Difference in pRR|-17.27|||||TWO_SIDED|95.0|-49.75|15.21||||||||15.21|-49.75|
73825849|NCT05116202|147197543|SUPERIORITY||Difference in pRR|-6.82|||||TWO_SIDED|95.0|-31.31|17.68||||||||17.68|-31.31|
73825850|NCT05116202|147197543|SUPERIORITY||Difference in pRR|-31.82|||||TWO_SIDED|95.0|-63.79|0.16||||||||0.16|-63.79|
73825851|NCT05116202|147197543|SUPERIORITY||Difference in pRR|-21.82|||||TWO_SIDED|95.0|-53.44|9.8||||||||9.80|-53.44|
73825852|NCT05116202|147197544|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|0.42|10.42||||||||10.42|0.42|
73825853|NCT05116202|147197544|SUPERIORITY||Hazard Ratio (HR)|3.95|||||TWO_SIDED|95.0|0.79|19.7||||||||19.70|0.79|
73825854|NCT05116202|147197544|SUPERIORITY||Hazard Ratio (HR)|6.27|||||TWO_SIDED|95.0|0.73|53.7||||||||53.70|0.73|
73825855|NCT05116202|147197545|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.25|7.75||||||||7.75|0.25|
73825856|NCT05116202|147197545|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|0.35|12.62||||||||12.62|0.35|
73825857|NCT05116202|147197545|SUPERIORITY||Hazard Ratio (HR)|2.39|||||TWO_SIDED|95.0|0.22|26.32||||||||26.32|0.22|
73825858|NCT05116202|147197546|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.05|12.39||||||||12.39|0.05|
73825859|NCT05116202|147197546|SUPERIORITY||Hazard Ratio (HR)|2.59|||||TWO_SIDED|95.0|0.23|28.65||||||||28.65|0.23|
73825860|NCT05116202|147197546|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.07|18.58||||||||18.58|0.07|
73825861|NCT05116202|147197547|SUPERIORITY||Difference in ORR|-21.59|||||TWO_SIDED|95.0|-50.55|7.37||||||||7.37|-50.55|
73825862|NCT05116202|147197547|SUPERIORITY||Difference in ORR|-24.09|||||TWO_SIDED|95.0|-58.17|9.99||||||||9.99|-58.17|
73825863|NCT05116202|147197547|SUPERIORITY||Difference in ORR|0.91|||||TWO_SIDED|95.0|-33.58|35.4||||||||35.40|-33.58|
73825864|NCT03834506|147197559|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1677|TWO_SIDED|95.0|0.78|1.09||One-sided p-value based on log-rank test stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|||1.09|0.78|0.1677
73825865|NCT03834506|147197560|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0335|TWO_SIDED|95.0|0.71|1.01||One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.01|0.71|0.0335
73825866|NCT03834506|147197561|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0331|TWO_SIDED|95.0|0.74|1.01||One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.01|0.74|0.0331
73825867|NCT03834506|147197563|OTHER||Percent Difference|-1.8||||0.6545|TWO_SIDED|95.0|-10.7|7.1||Based on Miettinen \& Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|||7.1|-10.7|0.6545
73825868|NCT03834506|147197565|OTHER||Hazard Ratio (HR)|1.05||||0.6178|TWO_SIDED|95.0|0.77|1.43|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.43|0.77|0.6178
73825869|NCT03834506|147197566|OTHER||Hazard Ratio (HR)|1.54||||0.9788|TWO_SIDED|95.0|1.01|2.33|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||2.33|1.01|0.9788
73825870|NCT03834506|147197567|OTHER||Hazard Ratio (HR)|0.96||||0.297|TWO_SIDED|95.0|0.82|1.12|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.12|0.82|0.2970
73825871|NCT03834506|147197568|OTHER||Hazard Ratio (HR)|0.95||||0.2876|TWO_SIDED|95.0|0.78|1.15|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.15|0.78|0.2876
73825872|NCT04391842|147197579|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
73825873|NCT04391842|147197580|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
73825874|NCT02731300|147197583|SUPERIORITY_OR_OTHER||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups||||<0.05
73825875|NCT02731300|147197584|SUPERIORITY_OR_OTHER||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups||||<0.05
73825876|NCT02713178|147197585|SUPERIORITY||LSMD|-20.249||||0.4463|TWO_SIDED|95.0|-72.361|31.864|||ANOVA|||||31.864|-72.361|0.4463
73825877|NCT02713178|147197585|SUPERIORITY||LSMD|-28.796||||0.2749|TWO_SIDED|95.0|-80.483|22.892|||ANOVA|||||22.892|-80.483|0.2749
73825878|NCT02713178|147197586|SUPERIORITY||LSM treatment ratio|0.853||||0.0716|TWO_SIDED|95.0|0.717|1.014|||ANOVA|||||1.014|0.717|0.0716
73825879|NCT02713178|147197586|SUPERIORITY||LSM treatment ratio|0.913||||0.3004|TWO_SIDED|95.0|0.769|1.084|||ANOVA|||||1.084|0.769|0.3004
73825880|NCT02713178|147197588|SUPERIORITY|||||||0.1896|||||||Log Rank|||The overall distribution as estimated by the Kaplan-Meier analysis was compared between the EXPAREL arm and the placebo arm.||||0.1896
73825881|NCT02713178|147197588|SUPERIORITY|||||||0.2549|||||||Log Rank|||The overall distribution as estimated by the Kaplan-Meier analysis was compared between the EXPAREL arm and the placebo arm.||||0.2549
73825882|NCT00596271|147197593|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are \> 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio \> 0.5."|||||<|0.0001||95.0|||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. IC51+Placebo group in terms of the GMT for anti- JEV neutralizing antibody at day 56. An observed cases approach will be applied for the primary analysis||||<0.0001
73825883|NCT00596271|147197597|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are \> 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio \> 0.5."|||||<|0.0001||95.0|||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. HAVRIX+Placebo group in terms of the GMT for HAV antibody at day 28. An observed cases approach will be applied for the primary analysis.||||<0.0001
73825884|NCT00689338|147197655|SUPERIORITY_OR_OTHER||estimate of survival|53.8|||||TWO_SIDED|95.0|45.9|60.9|||Kaplan-Meier|||Kaplan-Meier estimate of survival at Day 90 (survivor function).||60.9|45.9|
73825885|NCT00078286|147197735|NON_INFERIORITY_OR_EQUIVALENCE|\*Power analysis already provided.|Difference in mean change score|-0.3||||0.89||95.0|||||Mixed Models Analysis|Significance was tested at p=.05.||A hierarchical mixed model was used, analyzing the fixed effects of treatment, the natural log of time, natural log of time squared, the interactions of time and time squared with treatment and site, as well as the random effects of patient, patient-by-time, and square of patient-by-time.||||0.89
73825886|NCT00078286|147197736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||0.78||95.0|||||Cochran-Mantel-Haenszel|||Tests for differences of proportions were used to examine the composite cardiovascular status outcome at the end of acute treatment. Chi-square tests were used to test for overall treatment differences, with a Mantel Haenszel test performed to examine treatment differences when controlling for clinical site. The primary analyses were conducted on the tri-level cardiovascular status outcome.||||.78
73825887|NCT01409239|147197767|SUPERIORITY_OR_OTHER|||||||0.05||||||Wilcoxon rank-sum was used to determine differences between groups.|Wilcoxon (Mann-Whitney)|||Since this was a pilot study no formal power analysis was possible. It was hypothesized that IV insulin would be associated with lower LF/HF HRV.||||0.05
73825888|NCT03246347|147197778|SUPERIORITY||Proportion|0.6111|||<|0.001|TWO_SIDED|95.0|0.4346|0.7686|||One-sided test for binomial proportions|||The 12-month PSA CR rate with ADT + docetaxel is 27.7% (Sweeney 2015); we estimated that the lower limit of the 95% CI was 23.4%. We sought to test the null hypothesis that the 52-week PSA CR rate for subjects treated with study therapy was \<=25%. We anticipated enrolling 39 subjects and this design would provide 90% power with a 1-sided alpha =0.10 significance level, assuming the true 52-week PSA CR rate was 45%. An improvement from 25% to 45% in 52-week PSA CR rate was considered important.||.7686|.4346|<0.001
73825889|NCT02674503|147197803|SUPERIORITY|||||||0.02||||||Linear fixed effect models adjusted for time in months|Regression, Linear|||||||0.02
73825890|NCT02674503|147197807|SUPERIORITY|||||||0.13|||||||Regression, Linear|Linear effects model adjusted for time (in months)||||||0.13
73825891|NCT02674503|147197809|SUPERIORITY|||||||0.02|||||||Regression, Linear|Linear mixed effects models adjusted for time (in months)||||||0.02
73825892|NCT01022203|147197816|SUPERIORITY_OR_OTHER||Slope|0.0001|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes, for veterans and their partners. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.||||<0.0001
73825893|NCT01022203|147197817|SUPERIORITY_OR_OTHER||Slope|0.004|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes for veterans. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.||||<0.001
73825894|NCT01022203|147197818|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||General linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions as described for previous analyses.||||<0.0001
73825895|NCT02371616|147197903|NON_INFERIORITY|Inferences: upper end of the 2-sided 95% CI for the treatment difference for the estimated effect of Test relative to Comparator, for success, should be \<=6mm. (i.e., Test is no more than 6mm inferior to Comparator).|Least square (LS) mean difference|2.67||||0.2678|TWO_SIDED|95.0|-2.06|7.4||From ANCOVA model: change from baseline as the response variable, treatment group, baseline Schiff stratum and study site as fixed effects, with baseline VAS score as covariate.|ANCOVA||Difference is first named treatment minus second named dentifrice such that a negative difference favors the first named treatment.|Statistical analysis applies to change from baseline at week 8 for test and comparator dentifrice.||7.40|-2.06|0.2678
73825896|NCT00754741|147197907|SUPERIORITY_OR_OTHER|||||||0.763|TWO_SIDED||||||ANOVA|||||||0.763
73825897|NCT00754741|147197907|SUPERIORITY_OR_OTHER|||||||0.285|TWO_SIDED||||||ANOVA|||||||0.285
73825898|NCT00754741|147197908|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||ANOVA|||||||0.380
73825899|NCT00754741|147197908|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||ANOVA|||||||0.084
73825900|NCT00754741|147197909|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED||||||ANOVA|||||||0.667
73825901|NCT00754741|147197909|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANOVA|||||||0.530
73825902|NCT00754741|147197910|SUPERIORITY_OR_OTHER|||||||0.881|TWO_SIDED||||||ANOVA|||||||0.881
73825903|NCT00754741|147197910|SUPERIORITY_OR_OTHER|||||||0.849|TWO_SIDED||||||ANOVA|||||||0.849
73825904|NCT00754741|147197911|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED||||||Chi-squared|||||||0.134
73825905|NCT00754741|147197911|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Chi-squared|||||||0.714
73825906|NCT00754741|147197912|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED||||||ANOVA|||||||0.291
73825907|NCT00754741|147197912|SUPERIORITY_OR_OTHER|||||||0.968|TWO_SIDED||||||ANOVA|||||||0.968
73825908|NCT00754741|147197913|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||ANOVA|||||||0.671
73825909|NCT00754741|147197913|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||ANOVA|||||||0.399
73825910|NCT00754741|147197914|SUPERIORITY_OR_OTHER|||||||0.829|TWO_SIDED||||||ANOVA|||||||0.829
73825911|NCT00754741|147197914|SUPERIORITY_OR_OTHER|||||||0.283|TWO_SIDED||||||ANOVA|||||||0.283
73825912|NCT00754741|147197915|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED||||||ANOVA|||||||0.971
73825913|NCT00754741|147197915|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||ANOVA|||||||0.115
73825914|NCT00754741|147197916|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||ANOVA|||||||0.573
73825915|NCT00754741|147197916|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||ANOVA|||||||0.443
73825916|NCT00754741|147197917|SUPERIORITY_OR_OTHER|||||||0.469|TWO_SIDED||||||ANOVA|||||||0.469
73825917|NCT00754741|147197917|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||ANOVA|||||||0.369
73825918|NCT00754741|147197918|SUPERIORITY_OR_OTHER|||||||0.779|TWO_SIDED||||||ANOVA|||||||0.779
73825919|NCT00754741|147197918|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||ANOVA|||||||0.733
73825920|NCT00754741|147197919|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED||||||ANOVA|||||||0.952
73825921|NCT00754741|147197919|SUPERIORITY_OR_OTHER|||||||0.856|TWO_SIDED||||||ANOVA|||||||0.856
73825922|NCT00754741|147197920|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED||||||Chi-squared|||||||0.419
73825923|NCT00754741|147197920|SUPERIORITY_OR_OTHER|||||||0.998|TWO_SIDED||||||Chi-squared|||||||0.998
73825924|NCT04152200|147197929|OTHER|Not applied|Least Squares (LS) Mean|-33.33|STANDARD_ERROR_OF_MEAN|17.63|||TWO_SIDED|95.0|-81.82|15.16|||Mixed model repeated measures (MMRM)|||Restricted maximum likelihood (REML) based Mixed Model Repeated Measures (MMRM) was used to test against the null hypothesis of mean change from baseline outcome being equal to 0. The model includes scheduled visits and baseline plasma oxalate (μmol/L) as fixed effects and patient as a random factor. Autoregressive (1) was used to model the within-patient variability.||15.16|-81.82|
73825925|NCT04152200|147197930|OTHER|Not applied|Least Squares (LS) Mean|-42.43|STANDARD_ERROR_OF_MEAN|3.95|||TWO_SIDED|95.0|-50.71|-34.15|||MMRM|||REML based Mixed Model Repeated Measures MMRM was used to test against the null hypothesis of mean change from baseline outcome being equal to 0. The model includes scheduled visits and baseline plasma oxalate (μmol/L) as fixed effects and patient as a random factor. Autoregressive (1) was used to model the within-patient variability.||-34.15|-50.71|
73825926|NCT00593814|147197960|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
73825927|NCT02699996|147197965|SUPERIORITY||Mean Difference (Final Values)|0.52|||<|0.01|TWO_SIDED|95.0|0.17|0.86|||t-test, 2 sided|df = 14||RTQ-Survivor Adolescent Responsibility Score||0.86|0.17|<.01
73825928|NCT02699996|147197965|SUPERIORITY||Mean Difference (Final Values)|0.67|||<|0.01|TWO_SIDED|95.0|0.27|1.07|||t-test, 2 sided|df=14||RTQ-Overall Readiness Score||1.07|0.27|<.01
73825929|NCT02699996|147197966|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.02|TWO_SIDED|95.0|0.05|0.42|||t-test, 2 sided|df=14||TRI-total Score||0.42|0.05|0.02
73825930|NCT02699996|147197966|SUPERIORITY||Mean Difference (Final Values)|0.49|||<|0.01|TWO_SIDED|95.0|0.26|0.73|||t-test, 2 sided|df=14||TRI Knowledge score||0.73|0.26|<.01
73825931|NCT02699996|147197966|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.053|TWO_SIDED|95.0|-0.0044|0.6|||t-test, 2 sided|df=14||TRI Skills/Self-Efficacy Score||0.60|-0.0044|0.053
73825932|NCT02699996|147197966|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.03|TWO_SIDED|95.0|0.02|0.24|||t-test, 2 sided|df=14||TRI Beliefs/Expectations score||0.24|0.02|0.03
73825933|NCT02699996|147197966|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.01|TWO_SIDED|95.0|0.11|0.69|||t-test, 2 sided|df=14||TRI Goals/Motivation score||0.69|0.11|<.01
73825934|NCT02699996|147197966|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.61|TWO_SIDED|95.0|-0.16|0.26|||t-test, 2 sided|df=14||Relationship/Communication Score||0.26|-0.16|0.61
73825935|NCT02699996|147197966|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.65|TWO_SIDED|95.0|-0.37|0.57|||t-test, 2 sided|df=14||TRI Psychosocial/Emotional Score||0.57|-0.37|0.65
73825936|NCT02699996|147197967|SUPERIORITY||Median Difference (Final Values)|-1.64||||0.56|TWO_SIDED|95.0|-7.62|4.34|||t-test, 2 sided|df = 13||||4.34|-7.62|.56
73825937|NCT02699996|147197968|SUPERIORITY||Mean Difference (Final Values)|-1.74||||0.42|TWO_SIDED|95.0|-6.23|2.75|||t-test, 2 sided|df = 14||||2.75|-6.23|.42
73825938|NCT02699996|147197969|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.26|TWO_SIDED|95.0|-0.8|0.23|||t-test, 2 sided|df = 14||||0.23|-0.80|.26
73825939|NCT02699996|147197970|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.03|TWO_SIDED|95.0|0.03|0.52|||t-test, 2 sided|df = 14||||0.52|0.03|.03
73825940|NCT02699996|147197971|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.2|TWO_SIDED|95.0|-0.12|0.52|||t-test, 2 sided|df = 14||Body Health Subscale||0.52|-0.12|.20
73825941|NCT02699996|147197971|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.4|TWO_SIDED|95.0|-0.46|0.2|||t-test, 2 sided|df = 14||Personal Growth Subscale||0.20|-0.46|.40
73825942|NCT02699996|147197971|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.29|TWO_SIDED|95.0|-0.09|0.29|||t-test, 2 sided|df = 14||Memory Subscale||0.29|-0.09|.29
73825943|NCT02699996|147197972|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.08|TWO_SIDED|95.0|-0.4|0.03|||t-test, 2 sided|df = 14||||0.03|-0.40|.08
73825944|NCT03205150|147197985|SUPERIORITY||Mean Difference (Net)|-13.29|STANDARD_ERROR_OF_MEAN|7.35||0.075|TWO_SIDED|80.0|-22.8|-3.78|||ANCOVA|||||-3.78|-22.80|0.075
73825945|NCT03205150|147197985|SUPERIORITY||Mean Difference (Net)|-21.64|STANDARD_ERROR_OF_MEAN|7.49||0.005|TWO_SIDED|80.0|-31.33|-11.94|||ANCOVA|||||-11.94|-31.33|0.005
73825946|NCT03205150|147197985|SUPERIORITY||Mean Difference (Net)|8.35|STANDARD_ERROR_OF_MEAN|6.14||0.178|TWO_SIDED|80.0|0.41|16.29|||ANCOVA|||||16.29|0.41|0.178
73825947|NCT03205150|147197986|SUPERIORITY||Mean Difference (Net)|-1.73|STANDARD_ERROR_OF_MEAN|1.45||0.235|TWO_SIDED|80.0|-3.6|0.14|||ANCOVA|||||0.14|-3.60|0.235
73825948|NCT03205150|147197986|SUPERIORITY||Mean Difference (Net)|-4.26|STANDARD_ERROR_OF_MEAN|1.46||0.004|TWO_SIDED|80.0|-6.14|-2.37|||ANCOVA|||||-2.37|-6.14|0.004
73825949|NCT03205150|147197986|SUPERIORITY||Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|1.19||0.037|TWO_SIDED|80.0|0.98|4.07|||ANCOVA|||||4.07|0.98|0.037
73825950|NCT03205150|147197987|SUPERIORITY||Mean Difference (Net)|-3.15|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|80.0|-4.22|-2.08|||ANCOVA|||||-2.08|-4.22|<.001
73825951|NCT03205150|147197987|SUPERIORITY||Mean Difference (Net)|-4.18|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|80.0|-5.28|-3.08|||ANCOVA|||||-3.08|-5.28|<.001
73825952|NCT03205150|147197987|SUPERIORITY||Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|0.71||0.148|TWO_SIDED|80.0|0.12|1.94|||ANCOVA|||||1.94|0.12|0.148
73825953|NCT03205150|147197995|SUPERIORITY||Mean Difference (Net)|-11.15|STANDARD_ERROR_OF_MEAN|4.36||0.013|TWO_SIDED|80.0|-16.79|-5.5|||ANCOVA|||||-5.50|-16.79|0.013
73825954|NCT03205150|147197995|SUPERIORITY||Mean Difference (Net)|-14.71|STANDARD_ERROR_OF_MEAN|4.43||0.001|TWO_SIDED|80.0|-20.43|-8.98|||ANCOVA|||||-8.98|-20.43|0.001
73825955|NCT03205150|147197995|SUPERIORITY||Mean Difference (Net)|3.56|STANDARD_ERROR_OF_MEAN|3.65||0.332|TWO_SIDED|80.0|-1.15|8.28|||ANCOVA|||||8.28|-1.15|0.332
73825956|NCT01095835|147197998|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|||||||0.08
73825957|NCT00871624|147198009|NON_INFERIORITY_OR_EQUIVALENCE|A difference in the mean four-point NIV intolerance score of 1 over the course of the study or between groups was considered through investigator consensus to be clinically meaningful. Assuming that the SD of NIV intolerance scores was 1 and that an alpha of 0.05 would be used for testing, it was determined that 18 subjects were needed in each group to achieve an 80% power.|Odds Ratio (OR)|1.44||||0.54|TWO_SIDED|95.0|0.44|4.7|||Chi-squared|||||4.7|0.44|0.54
73825958|NCT00871624|147198010|OTHER|||||||0.3|||||||Chi-squared|||||||0.3
73825959|NCT00789321|147198043|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.7||||0.001||90.0|-18.1|-5.4|||ANCOVA|Change from baseline in systolic blood pressure included as covariate||||-5.4|-18.1|0.001
73825960|NCT00789321|147198044|SUPERIORITY_OR_OTHER||Least Squares Mean|39.0||||0.001||95.0|17.9|60.1|||ANCOVA|Change from baseline in systolic blood pressure included as covariate||||60.1|17.9|0.001
73825961|NCT00729521|147198045|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.92|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.88|0.95|||Mixed Models Analysis|Mixed Effects Poisson Regression|Comparison group is the control arm.|||0.95|0.88|<0.05
73825962|NCT00729521|147198045|SUPERIORITY_OR_OTHER||Incident Rate Ratio|0.91|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.88|0.94|||Mixed Models Analysis|Mixed Effected Poisson Model Regression|Comparison group is the control arm.|||0.94|0.88|<.05
73825963|NCT03652818|147198046|SUPERIORITY||Least Square (LS) Mean Difference|-25.2868|STANDARD_ERROR_OF_MEAN|16.1594|||ONE_SIDED|90.0||-4.421|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group B||-4.4210||
73825964|NCT03652818|147198046|SUPERIORITY||LS Mean Difference|-0.2756|STANDARD_ERROR_OF_MEAN|16.3283|||ONE_SIDED|90.0||20.8083|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group C vs. Group B||20.8083||
73825965|NCT03652818|147198046|SUPERIORITY||LS Mean Difference|-65.9241|STANDARD_ERROR_OF_MEAN|17.2146|||ONE_SIDED|90.0||-43.6959|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group C vs. Group A||-43.6959||
73825966|NCT03652818|147198046|SUPERIORITY||LS Mean Difference|-65.6486|STANDARD_ERROR_OF_MEAN|16.8753|||ONE_SIDED|90.0||-43.8584|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group B vs. Group A||-43.8584||
73825967|NCT03652818|147198046|SUPERIORITY||LS Mean Difference|-90.9353|STANDARD_ERROR_OF_MEAN|17.1044|||ONE_SIDED|90.0||-68.8494|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group A||-68.8494||
73825968|NCT03652818|147198046|SUPERIORITY||LS Mean Difference|-25.0112|STANDARD_ERROR_OF_MEAN|16.5376|||ONE_SIDED|90.0||-3.6571|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group C||-3.6571||
73825969|NCT03652818|147198046|SUPERIORITY||LS Mean Difference|10.9546|STANDARD_ERROR_OF_MEAN|21.0237|||ONE_SIDED|90.0||38.1014|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group E vs. Group D||38.1014||
73825970|NCT03652818|147198047|SUPERIORITY||LS Mean Difference|33.6821|STANDARD_ERROR_OF_MEAN|20.1209|||ONE_SIDED|90.0|7.7011||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group B|||7.7011|
73825971|NCT03652818|147198047|SUPERIORITY||LS Mean Difference|6.1658|STANDARD_ERROR_OF_MEAN|20.3312|||ONE_SIDED|90.0|-20.0868||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group C vs. Group B|||-20.0868|
73825972|NCT03652818|147198047|SUPERIORITY||LS Mean Difference|77.3395|STANDARD_ERROR_OF_MEAN|21.4347|||ONE_SIDED|90.0|49.662||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group C vs. Group A|||49.6620|
73825973|NCT03652818|147198047|SUPERIORITY||LS Mean Difference|71.1737|STANDARD_ERROR_OF_MEAN|21.0123|||ONE_SIDED|90.0|44.0417||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group B vs. Group A|||44.0417|
73825974|NCT03652818|147198047|SUPERIORITY||LS Mean Difference|104.8558|STANDARD_ERROR_OF_MEAN|21.2975|||ONE_SIDED|90.0|77.3555||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group A|||77.3555|
73825975|NCT03652818|147198047|SUPERIORITY||LS Mean Difference|27.5163|STANDARD_ERROR_OF_MEAN|20.5918|||ONE_SIDED|90.0|0.9272||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group C|||0.9272|
73825976|NCT03652818|147198047|SUPERIORITY||LS Mean Difference|-30.1223|STANDARD_ERROR_OF_MEAN|26.1776|||ONE_SIDED|90.0|-63.924||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group E vs. Group D|||-63.9240|
73825977|NCT01669434|147198051|SUPERIORITY||Risk Ratio (RR)|0.81||||0.03|TWO_SIDED|95.0|0.67|0.97|||Fisher Exact|||||0.97|0.67|0.03
73825978|NCT01669434|147198052|SUPERIORITY||Risk Ratio (RR)|0.6||||0.44|TWO_SIDED|95.0|0.23|1.6|||Fisher Exact|||||1.60|0.23|0.44
73825979|NCT01669434|147198053|SUPERIORITY||Risk Ratio (RR)|1.2||||1|TWO_SIDED|95.0|0.48|2.99|||Fisher Exact|||||2.99|0.48|1.0
73825980|NCT01669434|147198054|SUPERIORITY||Risk Ratio (RR)|1.01||||1|TWO_SIDED|95.0|0.81|1.26|||Fisher Exact|||||1.26|0.81|1.0
73825981|NCT01669434|147198055|SUPERIORITY||Risk Ratio (RR)|1.95||||0.01|TWO_SIDED|95.0|1.14|3.34|||Fisher Exact|||||3.34|1.14|0.01
73825982|NCT01669434|147198056|SUPERIORITY||Risk Ratio (RR)|0.49||||0.02|TWO_SIDED|95.0|0.28|0.86|||Fisher Exact|||||0.86|0.28|0.02
73825983|NCT00830219|147198063|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.53||||||90.0|99.16|108.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.09|99.16|
73825984|NCT00830219|147198064|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.3||||||90.0|97.56|107.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.27|97.56|
73825985|NCT00830219|147198065|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.54||||||90.0|97.53|107.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.8|97.53|
73825986|NCT01811732|147198066|NON_INFERIORITY|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in sample rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|-2.6|||||TWO_SIDED|95.0|-8.8|3.6||||||||3.6|-8.8|
73825987|NCT00288912|147198073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.007|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.||0.2|-1.0|0.007
73825988|NCT00288912|147198073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.105|TWO_SIDED|95.0|-0.8|0.1|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.||0.1|-0.8|0.105
73825989|NCT00288912|147198074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.093|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.0|-0.5|0.093
73825990|NCT00288912|147198074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.43|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.2|-0.2|0.43
73825991|NCT00288912|147198075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.4|-0.3|0.78
73825992|NCT00288912|147198075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.79|TWO_SIDED|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.4|-0.3|0.79
73825993|NCT00288912|147198076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.043|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.8|0.0|0.043
73825994|NCT00288912|147198076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.066|TWO_SIDED|95.0|0.0|0.7|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.7|0.0|0.066
73825995|NCT01868646|147198077|SUPERIORITY|||||||0.0002||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0002
73825996|NCT01868646|147198078|SUPERIORITY|||||||0.0426||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0426
73825997|NCT01868646|147198079|SUPERIORITY|||||||0.599||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.5990
73825998|NCT01868646|147198080|SUPERIORITY|||||||0.6215||||||"The p-value associated with treatment factor of mean value at baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.6215
73825999|NCT01868646|147198081|SUPERIORITY|||||||0.6155||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.6155
73826000|NCT01868646|147198081|SUPERIORITY|||||||0.7507||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.7507
73826001|NCT01868646|147198081|SUPERIORITY|||||||0.4195||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.4195
73826002|NCT01868646|147198081|SUPERIORITY|||||||0.3609||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.3609
73826003|NCT01868646|147198082|SUPERIORITY|||||||0.0605|||||||t-test, 2 sided|||||||0.0605
73826004|NCT01868646|147198083|SUPERIORITY|||||||0.0726|||||||t-test, 2 sided|||||||0.0726
73826005|NCT01868646|147198084|SUPERIORITY|||||||0.3108|||||||Fisher Exact|||||||0.3108
73826006|NCT01868646|147198085|SUPERIORITY|||||||0.2934|||||||t-test, 2 sided|||||||0.2934
73826007|NCT01868646|147198086|SUPERIORITY|||||||0.341|||||||t-test, 2 sided|||||||0.3410
73826008|NCT01868646|147198087|SUPERIORITY|||||||0.1577|||||||t-test, 2 sided|||Satisfaction||||0.1577
73826009|NCT01868646|147198087|SUPERIORITY|||||||0.5262|||||||t-test, 2 sided|||Hyperglycemia||||0.5262
73826010|NCT01868646|147198087|SUPERIORITY|||||||0.7417|||||||t-test, 2 sided|||Hypoglycemia||||0.7417
73826011|NCT01240382|147198165|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in mean change in fluorescein staining score from baseline was assessed on the non-inferiority margin (0.34) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Median Difference (Final Values)|-0.03||||||95.0|-0.405|0.338|||l|||||0.338|-0.405|
73826012|NCT01240382|147198166|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.67||||0.01||95.0|-1.18|-0.67|||t-test, 2 sided|||||-0.67|-1.18|0.010
73826013|NCT02456727|147198167|SUPERIORITY||Mean Difference (Net)|-0.3714|STANDARD_ERROR_OF_MEAN|0.2039||0.0691|TWO_SIDED|95.0|-0.772|0.0291|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.0291|-0.7720|0.0691
73826014|NCT02456727|147198168|SUPERIORITY||Mean Difference (Net)|-0.1631|STANDARD_ERROR_OF_MEAN|0.246||0.5077|TWO_SIDED|95.0|-0.6452|0.319|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.319|-0.6452|0.5077
73826015|NCT02456727|147198169|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0724|STANDARD_ERROR_OF_MEAN|0.0399||0.24|TWO_SIDED|95.0|-0.0058|0.1506|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1506|-0.0058|0.24
73826016|NCT02456727|147198170|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0531|STANDARD_ERROR_OF_MEAN|0.0487||0.17|TWO_SIDED|95.0|-0.0422|0.1485|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1485|-0.0422|0.17
73826017|NCT02456727|147198171|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0625|STANDARD_ERROR_OF_MEAN|0.0396||0.17|TWO_SIDED|95.0|-0.0151|0.1401|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.1401|-0.0151|0.17
73826018|NCT02456727|147198172|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0882|STANDARD_ERROR_OF_MEAN|0.0488||0.4|TWO_SIDED|95.0|-0.0075|0.184|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.184|-0.0075|0.40
73826019|NCT02456727|147198173|SUPERIORITY||Mean Difference (Net)|-0.2643|STANDARD_ERROR_OF_MEAN|0.1782||0.1387|TWO_SIDED|95.0|-0.6136|0.0851|||ANCOVA|The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).|||0.0851|-0.6136|0.1387
73826020|NCT02456727|147198174|SUPERIORITY||Mean Difference (Net)|-0.2334|STANDARD_ERROR_OF_MEAN|0.2124||0.2725|TWO_SIDED|95.0|-0.6497|0.1829|||ANCOVA|The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).|||0.1829|-0.6497|0.2725
73826021|NCT02456727|147198175|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0426|STANDARD_ERROR_OF_MEAN|0.0388||0.07|TWO_SIDED|95.0|-0.0334|0.1185|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1185|-0.0334|0.07
73826022|NCT02456727|147198176|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0283|STANDARD_ERROR_OF_MEAN|0.0477||0.07|TWO_SIDED|95.0|-0.0651|0.1218|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1218|-0.0651|0.07
73826023|NCT02456727|147198177|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0262|STANDARD_ERROR_OF_MEAN|0.0356||0.02|TWO_SIDED|95.0|-0.0436|0.0961|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.0961|-0.0436|0.02
73826024|NCT02456727|147198178|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0323|STANDARD_ERROR_OF_MEAN|0.044||0.06|TWO_SIDED|95.0|-0.0539|0.1186|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.1186|-0.0539|0.06
73826025|NCT02456727|147198179|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.15||0.1475|TWO_SIDED|95.0|-0.5288|0.0795|||t-test, 2 sided|The outcome is the change of PGIC from baseline to 12 weeks.|The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.0795|-0.5288|0.1475
73826026|NCT02456727|147198180|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3038|TWO_SIDED|95.0|-0.546|0.1706|||t-test, 2 sided|The outcome is the change of PGIC from baseline to 12 weeks.|The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.1706|-0.546|0.3038
73826027|NCT02456727|147198181|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0251|STANDARD_ERROR_OF_MEAN|0.0392||0.03|TWO_SIDED|95.0|-0.0517|0.1018|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 12 weeks between two treatment arms (Individual-Group)|||0.1018|-0.0517|0.03
73826028|NCT02456727|147198182|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0018|STANDARD_ERROR_OF_MEAN|0.0481||0.02|TWO_SIDED|95.0|-0.0925|0.096|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 12 weeks between two treatment arms (Individual-Group)|||0.096|-0.0925|0.02
73826029|NCT02456727|147198183|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|-0.0104|STANDARD_ERROR_OF_MEAN|0.036||0|TWO_SIDED|95.0|-0.081|0.0602|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 24 weeks between two treatment arms (Individual-Group)|||0.0602|-0.081|0.00
73826030|NCT02456727|147198184|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0154|STANDARD_ERROR_OF_MEAN|0.0464||0.03|TWO_SIDED|95.0|-0.0755|0.1063|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 24 weeks between two treatment arms (Individual-Group)|||0.1063|-0.0755|0.03
73826031|NCT02456727|147198185|SUPERIORITY||Mean Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.5336||0.8778|TWO_SIDED|95.0|-0.9659|1.13|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.13|-0.9659|0.8778
73826032|NCT02456727|147198186|SUPERIORITY||Mean Difference (Net)|0.3623|STANDARD_ERROR_OF_MEAN|0.6252||0.5626|TWO_SIDED|95.0|-0.8667|1.5912|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.5912|-0.8667|0.5626
73826033|NCT02456727|147198187|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0362|STANDARD_ERROR_OF_MEAN|0.0399||0.05|TWO_SIDED|95.0|-0.0419|0.1144|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 12 weeks between two treatment arms (Individual-Group)|||0.1144|-0.0419|0.05
73826034|NCT02456727|147198188|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0647|STANDARD_ERROR_OF_MEAN|0.0466||0.22|TWO_SIDED|95.0|-0.0266|0.156|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 12 weeks between two treatment arms (Individual-Group)|||0.156|-0.0266|0.22
73826035|NCT02456727|147198189|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0523|STANDARD_ERROR_OF_MEAN|0.0415||0.12|TWO_SIDED|95.0|-0.029|0.1335|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 24 weeks between two treatment arms (Individual-Group)|||0.1335|-0.029|0.12
73826036|NCT02456727|147198190|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0928|STANDARD_ERROR_OF_MEAN|0.0498||0.44|TWO_SIDED|95.0|-0.0047|0.1903|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 24 weeks between two treatment arms (Individual-Group)|||0.1903|-0.0047|0.44
73826037|NCT02456727|147198191|SUPERIORITY||Mean Difference (Net)|0.4831|STANDARD_ERROR_OF_MEAN|0.5753||0.4014|TWO_SIDED|95.0|-0.6468|1.6129|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.6129|-0.6468|0.4014
73826038|NCT02456727|147198192|SUPERIORITY||Mean Difference (Net)|0.6617|STANDARD_ERROR_OF_MEAN|0.647||0.307|TWO_SIDED|95.0|-0.61|1.9334|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.9334|-0.61|0.307
73826039|NCT02456727|147198193|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0159|STANDARD_ERROR_OF_MEAN|0.0364||0.01|TWO_SIDED|95.0|-0.0555|0.0873|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 12 weeks between two treatment arms (Individual-Group)|||0.0873|-0.0555|0.01
73826040|NCT02456727|147198194|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0287|STANDARD_ERROR_OF_MEAN|0.0424||0.05|TWO_SIDED|95.0|-0.0544|0.1117|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 12 weeks between two treatment arms (Individual-Group)|||0.1117|-0.0544|0.05
73826041|NCT02456727|147198195|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0389|STANDARD_ERROR_OF_MEAN|0.0369||0.05|TWO_SIDED|95.0|-0.0335|0.1112|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 24 weeks between two treatment arms (Individual-Group)|||0.1112|-0.0335|0.05
73826042|NCT02456727|147198196|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0608|STANDARD_ERROR_OF_MEAN|0.0436||0.18|TWO_SIDED|95.0|-0.0247|0.1463|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 24 weeks between two treatment arms (Individual-Group)|||0.1463|-0.0247|0.18
73826043|NCT02456727|147198197|OTHER|The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.||||||0.1658|||||||McNemar|||Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.||||0.1658
73826044|NCT02456727|147198198|OTHER|The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.||||||0.1172|||||||McNemar|||Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.||||0.1172
73826045|NCT02456727|147198199|OTHER|The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.||||||0.0326|||||||Wilcoxon signed rank test|||Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.||||0.0326
73826046|NCT02456727|147198200|OTHER|The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.||||||0.0026|||||||Wilcoxon signed rank test|||Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.||||0.0026
73826047|NCT02456727|147198201|SUPERIORITY|||||||0.129||||||The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.|Wilcoxon (Mann-Whitney)|||||||0.129
73826048|NCT02456727|147198202|SUPERIORITY|||||||0.031||||||The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.|Wilcoxon (Mann-Whitney)|||||||0.031
73826049|NCT02456727|147198203|SUPERIORITY|Difference in change in proportion pre and post-treatment differs by treatment arm.||||||0.0059|||||||Mixed Models Analysis|||||||0.0059
73826050|NCT02456727|147198204|SUPERIORITY|||||||0.0385|||||||Mixed Models Analysis|||||||0.0385
73826051|NCT03829462|147198227|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5334|TWO_SIDED|95.0|0.7|1.98||The threshold for statistical significance was p=0.05|Log Rank|||To show an increase of median overall survival from 7 to 15 months (30% to 57% rates, respectively), with a HR=0.47 and a power of 80% and alpha=5%, 55 events are required for the 78 patients to be randomized considering 15% additional patients for lost to follow-up.||1.98|0.7|0.5334
73826052|NCT03829462|147198227|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8894|TWO_SIDED|95.0|0.59|1.82|||Chi-squared|||||1.82|0.59|0.8894
73826053|NCT03829462|147198228|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.1104|TWO_SIDED|95.0|0.4|1.11|||Log Rank|The threshold for statistical significance was p=0.05||||1.11|0.4|0.1104
73826054|NCT03829462|147198228|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.1165|TWO_SIDED|95.0|0.4|1.11|||Chi-squared|||||1.11|0.4|0.1165
73826055|NCT03829462|147198229|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.2425|TWO_SIDED|95.0|0.26|1.42||The threshold for statistical significance was p=0.05|Log Rank|||||1.42|0.26|0.2425
73826056|NCT03829462|147198229|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.2519|TWO_SIDED|95.0|0.26|1.42|||Chi-squared|||||1.42|0.26|0.2519
73826057|NCT03829462|147198230|SUPERIORITY||Percent difference|46.5||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
73826058|NCT03829462|147198231|SUPERIORITY||Percent difference|7.4||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
73826059|NCT00791999|147198238|SUPERIORITY_OR_OTHER||||||<|0.025||95.0||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic|||For ACR20 responder rate at Week 12, treatment comparisons versus placebo for the two CDP870 dose groups, the CDP870 200 mg group the CDP870 400 mg, were performed. The ACR20 responder rate in the CDP870 100 mg group was used for the secondary analysis.||||<0.025
73826060|NCT00791999|147198239|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic|||||||<0.05
73826061|NCT00427908|147198240|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response to be greater than or equal to -15% for rSBA-MenA.|Difference in percentage|6.44|||||TWO_SIDED|95.0|1.15|16.04||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenA. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenA titer from pre to post vaccination.||16.04|1.15|
73826062|NCT00427908|147198240|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenC.|Difference in percentage|13.18|||||TWO_SIDED|95.0|4.79|24.32||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenC. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenC titer from pre to post vaccination.||24.32|4.79|
73826063|NCT00427908|147198240|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenW-135.|Difference in percentage|4.41|||||TWO_SIDED|95.0|1.51|12.21||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenW-135. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenW-135 titer from pre to post vaccination.||12.21|1.51|
73826064|NCT00427908|147198240|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrux minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenY.|Difference in percentage|16.23|||||TWO_SIDED|95.0|8.99|26.78||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenY. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenY titer from pre to post vaccination.||26.78|8.99|
73826065|NCT00427908|147198243|NON_INFERIORITY|Criterion indicative of non-inferiority (serogroup C only): one month after vaccination, the lower limit of the 2-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Meningitec Group) in the percentage of subjects with rSBA titer ≥ 1:8 is greater than or equal to the predefined clinical limit of -15%.|Difference in vaccine response rate|1.47|||||TWO_SIDED|95.0|-0.27|7.89||||||To evaluate the non-inferiority of the vaccine response induced by Nimenrix™ conjugate vaccine when compared to the licensed Meningitec™ vaccine for MenC as measured by rSBA.||7.89|-0.27|
73826066|NCT01190813|147198335|SUPERIORITY_OR_OTHER||Percent Difference|11.0||||0.06|TWO_SIDED|95.0|-7.0|28.0|||Fisher Exact|It was not possible to adjust for baseline VA in these secondary analyses due to the small number of subjects meeting secondary outcome criteria.|Treatment group difference calculated as Levodopa - Placebo|A sample size of 129 participants provided 80% power with 1-sided type I error rate of 5% to reject the hypothesis of no difference between groups if the proportion improved was 30% in the levodopa group compared with 10% in the placebo group.||28|-7|0.06
73826067|NCT01190813|147198338|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-17.0|18.0|||||Levodopa - Placebo|||18|-17|
73826068|NCT01190813|147198339|SUPERIORITY_OR_OTHER||Percent Difference|-7.0|||||TWO_SIDED|95.0|-25.0|10.0||||||||10|-25|
73826069|NCT01190813|147198340|SUPERIORITY_OR_OTHER||Percent Difference|-5.0|||||TWO_SIDED|95.0|-22.0|13.0|||||Levodopa - Placebo|||13|-22|
73826070|NCT01190813|147198348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.65|TWO_SIDED|95.0|-1.9|1.3|||ANCOVA||Mean difference calculated as Levodopa - Placebo|||1.3|-1.9|0.65
73826071|NCT01190813|147198350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.44|TWO_SIDED|95.0|-1.6|1.8|||ANCOVA|||||1.8|-1.6|0.44
73826072|NCT01190813|147198352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.2|TWO_SIDED|95.0|-1.2|2.9|||ANCOVA|||||2.9|-1.2|0.20
73826073|NCT01190813|147198354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.17|TWO_SIDED||||||ANCOVA|||||||0.17
73826074|NCT01190813|147198358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.06|TWO_SIDED|95.0|-0.4|3.3||The alpha level was set to 0.0485 for the primary analysis to adjust for alpha spending of 0.015 for one interim analysis for efficacy conducted when outcome data were available for 50% of participants.|ANCOVA||Mean difference calculated as Levodopa - Placebo|With 129 participants, assuming a 1-sided type I error rate of 4.85%, there was 96% power to detect a difference in mean visual acuity between treatment groups at 18 weeks adjusted for baseline and for 1 interim analysis for futility if the true difference was 5 letters with SD of 7 letters and 82% power if the true difference was 3.75 letters||3.3|-0.4|0.06
73826075|NCT03191799|147198430|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
73826076|NCT03191799|147198430|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
73826077|NCT03191799|147198430|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
73826078|NCT03191799|147198430|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
73826079|NCT03191799|147198430|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
73826080|NCT03191799|147198432|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
73826081|NCT03191799|147198432|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
73826082|NCT03191799|147198432|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
73826083|NCT03191799|147198432|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
73826084|NCT03191799|147198432|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
73826085|NCT03191799|147198443|SUPERIORITY|||||||0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||0.0001
73826086|NCT03191799|147198443|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
73826087|NCT03191799|147198443|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
73826088|NCT03191799|147198443|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
73826089|NCT03191799|147198443|SUPERIORITY|||||||0.0004|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||0.0004
73826090|NCT03191799|147198445|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
73826091|NCT03191799|147198445|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
73826092|NCT03191799|147198445|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
73826093|NCT03191799|147198445|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
73826094|NCT03191799|147198445|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
73826095|NCT03191799|147198455|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
73826096|NCT03191799|147198455|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
73826097|NCT03191799|147198455|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
73826098|NCT03191799|147198455|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
73826099|NCT03191799|147198455|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
73826100|NCT03191799|147198456|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
73826101|NCT03191799|147198456|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
73826102|NCT03191799|147198456|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
73826103|NCT03191799|147198456|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
73826104|NCT03191799|147198456|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
73826105|NCT02974868|147198479|SUPERIORITY||Mean of Difference from Placebo|31.14|STANDARD_ERROR_OF_MEAN|6.25|<|0.0001|TWO_SIDED|95.0|18.78|43.5||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||43.50|18.78|<.0001
73826106|NCT02974868|147198479|SUPERIORITY||Mean of Difference from Placebo|49.18|STANDARD_ERROR_OF_MEAN|6.35|<|0.0001|TWO_SIDED|95.0|36.62|61.74||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||61.74|36.62|<.0001
73826107|NCT02974868|147198480|OTHER||Mean of Difference from Placebo|25.78|STANDARD_ERROR_OF_MEAN|10.64||0.0094|TWO_SIDED|90.0|7.98|43.58|||Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||43.58|7.98|0.0094
73826108|NCT02974868|147198480|OTHER||Mean of Difference from Placebo|46.61|STANDARD_ERROR_OF_MEAN|10.51|<|0.0001|TWO_SIDED|90.0|29.02|64.2|||Mixed Model Repeated Measure|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||64.20|29.02|<.0001
73826109|NCT02974868|147198485|OTHER||Difference in Percentage from Placebo|47.9|||<|0.0001|TWO_SIDED|90.0|34.2|60.7|||Chan and Zhang method|||||60.7|34.2|<.0001
73826110|NCT02974868|147198485|OTHER||Difference in Percentage from Placebo|61.7|||<|0.0001|TWO_SIDED|90.0|48.2|73.6|||Chan and Zhang method|||||73.6|48.2|<.0001
73826111|NCT03575702|147198569|NON_INFERIORITY|The non-inferiority margin is considered as change in mean daily urination episodes of 0,8 episodes per day|Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.34|=|0.5595|ONE_SIDED|95.0||0.38|||ANCOVA|The number of urination episodes at the initiation of therapy is used as covariate, and the therapy group is used as a factor.||"The null hypothesis is that effect of Urotol according to the assessment of mean daily urination episodes exceeds effect of Uritos.~A sample containing of 222 patients (111 per study group) is considered sufficient to prove the alternative hypothesis at the significance level 0.025% and study power 80%. Given the expected drop out rate during the treatment period, the total number of patients to be randomized is 300 (150 in each group)."||0.38||=0.5595
73826112|NCT03575702|147198570|OTHER||||||=|0.0008|||||||ANCOVA|||||||=0.0008
73826113|NCT03575702|147198571|OTHER||||||=|0.0099|||||||ANCOVA|||||||=0.0099
73826114|NCT03575702|147198572|OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73826115|NCT03575702|147198573|OTHER||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 2||||||<0.0001
73826116|NCT03575702|147198573|OTHER||||||=|0.0236|||||||ANCOVA|Changes in number of daily incontinence episodes - week 4||||||=0.0236
73826117|NCT03575702|147198573|OTHER||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 8||||||<0.0001
73826118|NCT03575702|147198573|OTHER||||||=|0.0018|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 2||||||=0.0018
73826119|NCT03575702|147198573|OTHER||||||=|0.3835|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 4||||||=0.3835
73826120|NCT03575702|147198573|OTHER||||||=|0.0088|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 8||||||=0.0088
73826121|NCT03575702|147198573|OTHER||||||=|0.0004|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 2||||||=0.0004
73826122|NCT03575702|147198573|OTHER||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 4||||||<0.0001
73826123|NCT03575702|147198573|OTHER||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 8||||||<0.0001
73826124|NCT03575702|147198574|OTHER|||||||0.0008|||||||ANCOVA|||||||0.0008
73826125|NCT03575702|147198575|OTHER||||||=|0.1348|||||||ANCOVA|Week 2 changes||||||=0.1348
73826126|NCT03575702|147198575|OTHER||||||=|0.3199|||||||ANCOVA|Week 4 changes||||||=0.3199
73826127|NCT03575702|147198575|OTHER||||||=|0.9537|||||||ANCOVA|Week 8 changes||||||=0.9537
73826128|NCT03575702|147198576|OTHER||||||=|0.5321|||||||t-test, 1 sided|Change week 12||||||=0.5321
73826129|NCT03575702|147198577|OTHER||||||=|0.4839|||||||t-test, 1 sided|Change week 12||||||=0.4839
73826130|NCT03575702|147198578|OTHER||||||=|0.86|||||||Chi-squared|||||||=0.86
73826131|NCT03903172|147198584|SUPERIORITY||||||=|0.25|||||||t-test, 2 sided|||Day 0||||=0.25
73826132|NCT03903172|147198584|SUPERIORITY||||||=|0.93|||||||t-test, 2 sided|||Day 1||||=.93
73826133|NCT03903172|147198585|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used acetominophen||||=1.0
73826134|NCT03903172|147198585|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used ibuprofen||||=1.0
73826135|NCT03903172|147198585|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used Cyclobenzaprine||||=1.0
73826136|NCT03903172|147198585|SUPERIORITY||||||=|0.11|||||||Fisher Exact|||Used Methocarbamol||||=.11
73826137|NCT03903172|147198585|SUPERIORITY||||||=|0.49|||||||Fisher Exact|||Used Hydroxyzine||||=.49
73826138|NCT03903172|147198585|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used an 'Other' non-pharmacologic medication||||=1.0
73826139|NCT03903172|147198586|SUPERIORITY||||||=|1|||||||Fisher Exact|||Any narcotic medication used||||=1.0
73826140|NCT01545388|147198587|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.678|||<|0.001|TWO_SIDED|95.0|-0.868|-0.489|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-0.489|-0.868|<0.001
73826141|NCT01545388|147198587|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.525|||<|0.001|TWO_SIDED|95.0|-0.713|-0.337|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-0.337|-0.713|<0.001
73826142|NCT01545388|147198587|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin (Δ) is set as 0.3% to show the non-inferiority of metformin 500 mg q.d. to metformin 250 mg b.i.d.|Difference in least squares means|0.153|||||TWO_SIDED|95.0|0.0|0.306||||||||0.306|0.000|
73826143|NCT01545388|147198588|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.59|||<|0.001|TWO_SIDED|95.0|-25.94|-11.24|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-11.24|-25.94|<0.001
73826144|NCT01545388|147198588|SUPERIORITY_OR_OTHER||Difference in least squares means|-16.34|||<|0.001|TWO_SIDED|95.0|-23.62|-9.06|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-9.06|-23.62|<0.001
73826145|NCT01545388|147198588|SUPERIORITY_OR_OTHER||Difference in least squares mean|2.25|||||TWO_SIDED|95.0|-3.63|8.14||||||||8.14|-3.63|
73826146|NCT01255163|147198591|OTHER|||||||0.016||||||threshold for significance (p \< 0.05)|Fisher Exact|||||||0.016
73826147|NCT01255163|147198592|OTHER|||||||0.098||||||"Threshold for statistical significance p \< 0.05.~Type III Tests of Fixed Effects Group \* VisitLong F (6, 52.008) = 1.902, p = 0.098"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED MMSE.tot BY Group Sex VisitLong WITH Age~* CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~* FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3)~* METHOD=REML~* PRINT=SOLUTION~* REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1)~* EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.098
73826148|NCT01255163|147198593|OTHER|||||||0.295||||||"Threshold for statistical significance p \< 0.05.~Type III Tests of Fixed Effects for Group\*VisitLong F (6, 52.281) = 1.254, p = 0.295"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED ADAS70 BY Group Sex VisitLong WITH Age~* CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~* FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3)~* METHOD=REML~* PRINT=SOLUTION~* REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1)~* EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.295
73826149|NCT01255163|147198594|OTHER|||||||0.141||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (6, 47.485) = 1.704, p = 0.141|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR BY Group Sex VisitLong WITH Age~CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.141
73826150|NCT01255163|147198595|OTHER|||||||0.031||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects: Group \* VisitLong F (6, 51.955) = 2.553, p = 0.031. Univarate Exendin-4 F(3, 51.386) = 2.734, p = 0.053. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.035).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR.sob BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.031
73826151|NCT01255163|147198596|OTHER|||||||0.703||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (2, 15.251) = 0.360, p = 0.703.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED TAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.703
73826152|NCT01255163|147198597|OTHER|||||||0.845||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (2, 15.828) = 0.170, p = 0.845.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED pTAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.845
73826153|NCT01255163|147198598|OTHER|||||||0.018||||||Type III Tests of Fixed Effects: Group \* VisitLong F (2, 16.614) = 5.142, p = 0.018. Univariate tests: Placebo F(1, 16.595) = 4.138, p = 0.058; Exendin-4 F(1, 16.595) = 6.262, p = 0.022. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.022).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED Ab42 BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.018
73826154|NCT01255163|147198599|OTHER|||||||0.009||||||Type III Tests of Fixed Effects: Group \* VisitLong F (8, 72.603) = 2.816, p = 0.009. Univarate Exendin-4 F(4, 72.944) = 4.834, p = 0.002. Pairwise comparisons for Exendin-4 showed a decrease in BMI baseline vs. 6 months (p = 0.029).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED BMI BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.009
73826155|NCT02495389|147198601|SUPERIORITY||Mean Difference (Final Values)|23.96|STANDARD_ERROR_OF_MEAN|2.7741|<|0.0001|TWO_SIDED|95.0|18.35|29.57|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) score after 12 weeks of therapy.||29.57|18.35|<.0001
73826156|NCT02495389|147198602|SUPERIORITY||Mean Difference (Final Values)|-51.62|STANDARD_ERROR_OF_MEAN|6.1584|<|0.0001|TWO_SIDED|95.0|-64.04|-39.2|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Urinary Distress Inventory score after 12 weeks of therapy.||-39.20|-64.04|<.0001
73826157|NCT02495389|147198603|SUPERIORITY||Mean Difference (Final Values)|-29.3|STANDARD_ERROR_OF_MEAN|5.4701|<|0.0001|TWO_SIDED|95.0|-40.33|-18.27|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Pelvic Organ Prolapse Distress Inventory score after 12 weeks of therapy.||-18.27|-40.33|<.0001
73826158|NCT02495389|147198604|SUPERIORITY||Mean Difference (Final Values)|-32.0|STANDARD_ERROR_OF_MEAN|6.1226|<|0.0001|TWO_SIDED|95.0|-44.35|-19.65|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Colo-Rectal-Anal Distress Inventory score after 12 weeks of therapy.||-19.65|-44.35|<.0001
73826159|NCT03834493|147198627|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6621|TWO_SIDED|95.0|0.88|1.22|||Log Rank||Stratified Cox model with Efron's tie handling method|||1.22|0.88|0.6621
73826160|NCT03834493|147198628|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4073|TWO_SIDED|95.0|0.84|1.14|||Log Rank||Stratified Cox model with Efron's tie handling method|||1.14|0.84|0.4073
73826161|NCT03834493|147198629|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||Stratified Cox model with Efron's tie handling method|||1.09|0.83|
73826162|NCT03834493|147198630|OTHER||Difference in Percentage|3.4|||||TWO_SIDED|95.0|-1.5|8.3|||||Stratified Miettinen and Nurminen method|||8.3|-1.5|
73826163|NCT03834493|147198631|OTHER||Difference in Percentage|0.3|||||TWO_SIDED|95.0|-3.4|4.1|||||Stratified Miettinen and Nurminen method|||4.1|-3.4|
73826164|NCT03834493|147198632|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-0.2|6.1|||||Stratified Miettinen and Nurminen method|||6.1|-0.2|
73826165|NCT03834493|147198634|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.86|1.15|||||Stratified Cox model with Efron's tie handling method|||1.15|0.86|
73826166|NCT03834493|147198635|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.74|1.09|||||Stratified Cox model with Efron's tie handling method|||1.09|0.74|
73826167|NCT03834493|147198636|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.82|1.35|||||Stratified Cox model with Efron's tie handling method|||1.35|0.82|
73826168|NCT03834493|147198637|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.85|1.51|||||Stratified Cox model with Efron's tie handling method|||1.51|0.85|
73826169|NCT05559905|147198640|SUPERIORITY||Difference in Least Squares Mean|-0.29||||0.578|TWO_SIDED|90.0|-1.16|0.58|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.58|-1.16|0.578
73826170|NCT05559905|147198641|SUPERIORITY||Difference in Least Squares Mean|-2.69||||0.201|TWO_SIDED|90.0|-6.17|-0.79|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||-0.79|-6.17|0.201
73826171|NCT05559905|147198647|SUPERIORITY||Difference in Least Squares Mean|-0.62||||0.736|TWO_SIDED|90.0|-3.65|2.42|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||2.42|-3.65|0.736
73826172|NCT05559905|147198648|SUPERIORITY||Difference in Least Squares Mean|-1.93||||0.646|TWO_SIDED|90.0|-8.88|5.02|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||5.02|-8.88|0.646
73826173|NCT05559905|147198649|SUPERIORITY||Difference in Least Squares Mean|-0.14||||0.849|TWO_SIDED|90.0|-1.31|1.04|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.04|-1.31|0.849
73826174|NCT05559905|147198650|SUPERIORITY||Difference in Least Squares Mean|-2.09||||0.371|TWO_SIDED|90.0|-5.97|1.78|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The TSS-AUC in each group and the differences in mean TSS-AUC between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.78|-5.97|0.371
73826175|NCT05559905|147198651|SUPERIORITY||Difference in Least Squares Mean|-1.82||||0.36|TWO_SIDED|90.0|-5.11|1.47|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The TSS-AUC-CFB in each group and the differences in mean TSS-AUC-CFB between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.47|-5.11|0.360
73826176|NCT05559905|147198652|SUPERIORITY||Difference in Least Squares Mean|-0.46||||0.459|TWO_SIDED|90.0|-1.5|0.57|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean peak TSS in each group and the differences in mean peak TSS between MK-4482 and placebo and the corresponding 2- sided 95% CI was computed based on the linear model.||0.57|-1.50|0.459
73826177|NCT05559905|147198654|SUPERIORITY||Difference in Percent (%)|3.42|||||TWO_SIDED|95.0|-18.28|24.5||||||||24.50|-18.28|
73826178|NCT05559905|147198655|SUPERIORITY||Difference in Percent (%)|2.89|||||TWO_SIDED|95.0|-19.37|25.69||||||||25.69|-19.37|
73826179|NCT05559905|147198656|SUPERIORITY||Difference in Percent (%)|-2.63|||||TWO_SIDED|95.0|-25.07|19.91||||||||19.91|-25.07|
73826180|NCT05559905|147198657|SUPERIORITY||Difference in Percent (%)|-16.18|||||TWO_SIDED|95.0|-36.77|5.64||||||||5.64|-36.77|
73826181|NCT05559905|147198658|SUPERIORITY||Difference in Percent (%)|-2.89|||||TWO_SIDED|95.0|-25.69|19.37||||||||19.37|-25.69|
73826182|NCT05559905|147198659|SUPERIORITY||Difference in Least Squares Mean|-0.69||||0.253|TWO_SIDED|90.0|-1.68|0.31|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.31|-1.68|0.253
73826183|NCT05559905|147198660|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.1708||95.0|0.83|3.57|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.57|0.83|0.1708
73826184|NCT05559905|147198661|SUPERIORITY||Difference in Least Squares Mean|-5.93||||0.257|TWO_SIDED|90.0|-14.61|2.75|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||2.75|-14.61|0.257
73826185|NCT05559905|147198662|SUPERIORITY||Difference in Least Squares Mean|-0.58||||0.453|TWO_SIDED|90.0|-1.88|0.71|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.71|-1.88|0.453
73826186|NCT05559905|147198663|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.9121|TWO_SIDED|95.0|0.44|2.51|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.51|0.44|0.9121
73826187|NCT05559905|147198664|SUPERIORITY||Difference in Least Squares Mean|-1.83||||0.377|TWO_SIDED|90.0|-5.25|1.6|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. The TSS-AUC in each group and the differences in mean TSS-AUC between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.60|-5.25|0.377
73826188|NCT05559905|147198665|SUPERIORITY||Difference in Least Squares Mean|-0.13||||0.958|TWO_SIDED|90.0|-4.28|4.02|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. The TSS-AUC-CFB in each group and the differences in mean TSS-AUC-CFB between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||4.02|-4.28|0.958
73826189|NCT05559905|147198666|SUPERIORITY||Difference in Least Squares Mean|-0.62||||0.52|TWO_SIDED|90.0|-2.21|0.98|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean peak TSS in each group and the differences in mean peak TSS between MK-4482 and placebo and the corresponding 2- sided 95% CI was computed based on the linear model.||0.98|-2.21|0.520
73826190|NCT05559905|147198668|SUPERIORITY||Hazard Ratio (HR)|2.24||||0.0459|TWO_SIDED|95.0|0.99|5.07|||Log Rank|Two-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||5.07|0.99|0.0459
73826191|NCT02756910|147198693|OTHER||percentile method|0.5|STANDARD_DEVIATION|1.96|<|0.05|TWO_SIDED|95.0|||||bootstrapping|||||||<0.05
73826192|NCT02240667|147198805|OTHER|||||||0.8496|||||||stratified log-rank test|||Persistence in both treatment groups was compared by means of the stratified Log-rank test||||0.8496
73826193|NCT00359203|147198829|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43||||0.04|TWO_SIDED|95.0|0.19|0.96|||Log Rank|The risk of syncope recurrence was based on HR obtained by means of the univarate Cox model, with the use of the Breslow method for ties.|numerator=pacemaker ON denominator=pacemaker OFF|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the Pm ON arm applying a log-rank test with a 2-sided significance level of 0.05. This analysis was planned as a comparison of the cumulative risk of syncope between the 2 groups with the use of a log-rank test.||0.96|0.19|0.04
73826194|NCT00359203|147198829|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the treatment arm applying a log-rank test with a 2-sided significance level of 0.05.|Hazard Ratio (HR)|0.43||||0.039|TWO_SIDED|95.0|0.19|0.96||For the final analysis the threshold of statistical significance was set at 0.04.|Log Rank||Numerator=pacemaker ON denominator=pacemaker OFF|||0.96|0.19|0.039
73826195|NCT04613518|147198848|SUPERIORITY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-35.7|43.4||||||||43.4|-35.7|
73826196|NCT01077323|147198863|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|0.87|||||TWO_SIDED|95.0|0.59|1.28|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||1.28|0.59|
73826197|NCT01077323|147198864|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|1.1|||||TWO_SIDED|95.0|0.8|1.5|||||ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.Rate ratios adjusted for propensity score of exenatide initiation using Cox Proportional Hazards Regression|||1.5|0.8|
73826198|NCT01077323|147198865|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|0.87|||||TWO_SIDED|95.0|0.36|2.09|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||2.09|0.36|
73826199|NCT01077323|147198866|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|1.39|||||TWO_SIDED|95.0|0.86|2.25|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||2.25|0.86|
73826200|NCT01764841|147198880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7331||||0.065|TWO_SIDED|97.5|0.5027|1.069|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.0690|0.5027|0.0650
73826201|NCT01764841|147198880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5333||||0.0005|TWO_SIDED|97.5|0.3568|0.7971|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% CI was calculated by using Cox proportional hazards model by comparison of Cipro 14/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||0.7971|0.3568|0.0005
73826202|NCT01764841|147198881|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.8615||||0.2944|TWO_SIDED|97.5|0.6264|1.1848|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 28 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.||1.1848|0.6264|0.2944
73826203|NCT01764841|147198881|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.7329||||0.0382|TWO_SIDED|97.5|0.5237|1.0256|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 14 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.||1.0256|0.5237|0.0382
73826204|NCT02616783|147198888|SUPERIORITY||Difference in Percentages|2.427|||<|0.001|TWO_SIDED|95.0|1.337|3.517|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% confidence intervals (CI) were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|||3.517|1.337|<0.001
73826205|NCT02616783|147198889|SUPERIORITY||Difference in percentages|2.036|||<|0.001|TWO_SIDED|95.0|1.168|2.904|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|||2.904|1.168|<0.001
73826206|NCT02616783|147198890|SUPERIORITY||Difference in percentages|1.749|||<|0.001|TWO_SIDED|95.0|0.726|2.771|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|||2.771|0.726|<0.001
73826207|NCT02616783|147198891|SUPERIORITY||Difference in percentages|1.351|||<|0.001|TWO_SIDED|95.0|0.602|2.099|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|||2.099|0.602|<0.001
73826208|NCT02616783|147198892|SUPERIORITY||Difference in percentages|-5.5||||0.18|TWO_SIDED|95.0|-11.8|1.6||P-values for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL were from the Fisher exact test.|Fisher Exact||Differences in percentages and 95% CI were generated based on exact method.|||1.6|-11.8|0.18
73826209|NCT02616783|147198893|SUPERIORITY||Difference in percentages|-1.0||||1|TWO_SIDED|95.0|-8.5|9.3|||Fisher Exact|P-values for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL were from the Fisher exact test.|Differences in percentages and 95% CI were generated based on exact method.|||9.3|-8.5|1.00
73826210|NCT02616783|147198894|SUPERIORITY||Difference in LSM|52.0||||0.053|TWO_SIDED|95.0|-1.0|106.0|||ANOVA|The p-value, difference in least square means (LSM), and its 95% CI were from ANOVA model with treatment as a fixed effect.||||106|-1|0.053
73826211|NCT02616783|147198895|SUPERIORITY||Difference in LSM|57.0||||0.051|TWO_SIDED|95.0|0.0|115.0|||ANOVA|The p-value, difference in LSM, and its 95% CI were from ANOVA model with treatment as a fixed effect.||||115|0|0.051
73826212|NCT04010461|147198925|SUPERIORITY||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.097|=|0.11|TWO_SIDED|95.0|-0.037|0.355|||t-test, 2 sided|df = 35 Note: 1 subject was excluded from analysis as extraction of FPN eigenvalues failed due to technical deficiencies with image data||Analysis used standard, open-source methods for pre-processing . First-level analysis used the general framework of the modified General Linear Model, implemented in SPM12 with temporal convolution. For the n-back activation task, the first-level design matrix included regressors for 2-back and 1-back conditions, as well as 24 movement parameters. Statistical testing was done to establish whether more or less BOLD (neural activity) change occurred between two conditions.||0.355|-0.037|=0.11
73826213|NCT04010461|147198925|SUPERIORITY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.116||0.94|TWO_SIDED|95.0|-0.245|0.227|||t-test, 2 sided|df = 35 Note: 1 subject excluded from analysis as FPN extraction of eigenvalues failed due to technical issues with image data||Analysis used standard, open-source routes for slice timing correction, field map correction, realignment, smoothing (6 mm Gaussian kernel) and spatial normalization (MNI-152). First-level analysis used the general framework of the modified General Linear Model, implemented in SPM12 with temporal convolution. For the n-back activation task, the first-level design matrix included regressors for 2-back and 1-back conditions, as well as 24 movement parameters.||0.227|-0.245|0.94
73826214|NCT04010461|147198926|OTHER|Group-level analyses were performed using a General Linear Model (GLM). For each individual voxel, a separate GLM was estimated, with first-level connectivity measures at this voxel as dependent variables, and groups or other subject-level identifiers as independent variables. Voxel-level hypotheses were evaluated using multivariate parametric statistics with random effects across subjects and sample covariance estimation across multiple measurements.|random field theory|0.0||||1|TWO_SIDED|||||Inferences were performed at the level of individual clusters (groups of contiguous voxels). Cluster-level inferences were based on parametric statistics from Gaussian Random Field theory.|random field theory|Results were thresholded using a combination of a cluster-forming p \< 0.001 voxel-level threshold, and cluster-size threshold of 25 voxels|Number indicates the number of clusters above the threshold of significance for the contrast between two arms (passive vs active)|The contrast reflects the difference in connectivity between the conditions/sessions, at the level of each subject, then spatially averaged across all subjects. Functional connectivity strength for the dlPFC seed was represented by Fisher-transformed bivariate correlation coefficients from a weighted general linear model (weighted-GLM), defined separately for each pair of seed and target areas, modeling the association between their BOLD signal time series.||||1
73826215|NCT04010461|147198926|OTHER|The applied test with random field theory uses a metric of spatial dispersion, testing against the null hypothesis that spatial clusters of difference across the analyzed region are no different from chance clustering.|random field theory|0.0||||1|TWO_SIDED||||||random field theory||Number indicates the number of clusters above the threshold of significance for the contrast between two arms (passive vs control)|Results were thresholded using a combination of a cluster-forming p \< 0.001 voxel-level threshold, and a corrected false discovery rate (FDR) p \< 0.05 cluster-size threshold.||||1
73826216|NCT04010461|147198927|SUPERIORITY||F-ratio|0.1||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
73826217|NCT04010461|147198928|SUPERIORITY|||||||0.55|||||||ANOVA|||||||0.55
73826218|NCT04010461|147198928|SUPERIORITY|||||||0.65|||||||ANOVA|||||||.65
73826219|NCT04010461|147198929|OTHER||cluster size|42.0||||0.54|TWO_SIDED|||||P-value above represents the lowest (most significant) value of the largest cluster, for the contrast of Passive \> Active, testing whether the cluster size is greater than chance.|random field theory||The estimated parameter is the size, in voxels, of the largest cluster. The applied test with random field theory tests whether the size of cluster difference across are no different from chance clustering.|Statistical thresholding using a random field model adjusted for multiple comparisons, with initial voxel magnitude/height threshold set at p \< 0.001 and peak and cluster-corrected significance levels obtained (false discovery rate \[FDR\]corrected), across the entire brain.||||0.54
73826220|NCT04010461|147198929|SUPERIORITY||cluster size|16.0||||0.93|TWO_SIDED|||||P-value above represents the lowest (most significant) value of the largest cluster, for the contrast of Passive \> Control, testing whether the size of this cluster is greater than one would expect by chance alone.|random field theory||The estimated parameter is the size, in voxels, of the largest cluster. The applied test with random field theory tests whether the size of cluster difference across are no different from chance clustering.|Statistical thresholding using a random field model adjusted for multiple comparisons, with initial voxel magnitude/height threshold set at p \< 0.001 and peak and cluster-corrected significance levels obtained (false discovery rate \[FDR\]corrected), across the entire brain..||||0.93
73826221|NCT04010461|147198930|SUPERIORITY||F-ratio|0.22||||0.8|TWO_SIDED||||||ANOVA|||Repeated measures ANOVA to test for differences in cerebral blood flow (perfusion) in the frontoparietal network||||0.8
73826222|NCT04010461|147198931|SUPERIORITY||F-ratio|3.96||||0.06|TWO_SIDED||||||ANOVA|||||||0.06
73826223|NCT04010461|147198931|SUPERIORITY||F-ratio|0.17||||0.68|TWO_SIDED||||||ANOVA|||||||0.68
73826224|NCT04010461|147198932|SUPERIORITY|Repeated measures ANOVA for 1- and 2-back conditions|F-ratio|0.72||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
73826225|NCT04010461|147198932|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.50
73826226|NCT02027025|147198967|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.64||0.4532|TWO_SIDED|95.0|-1.73|0.78|||ANCOVA|||||0.78|-1.73|0.4532
73826227|NCT02027025|147198967|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.65||0.4704|TWO_SIDED|95.0|-1.76|0.82|||ANCOVA|||||0.82|-1.76|0.4704
73826228|NCT02027025|147198968|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3013|TWO_SIDED|95.0|-0.56|0.17|||ANCOVA|||||0.17|-0.56|0.3013
73826229|NCT02027025|147198968|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2994|TWO_SIDED|95.0|-0.58|0.18|||ANCOVA|||||0.18|-0.58|0.2994
73826230|NCT02027025|147198969|SUPERIORITY|||||||0.3815|||||||Chi-squared|||||||0.3815
73826231|NCT02027025|147198969|SUPERIORITY|||||||0.7491|||||||Chi-squared|||||||0.7491
73826232|NCT02027025|147198970|SUPERIORITY|||||||0.8991|||||||Chi-squared|||||||0.8991
73826233|NCT02027025|147198970|SUPERIORITY|||||||0.8829|||||||Chi-squared|||||||0.8829
73826234|NCT04794751|147198989|NON_INFERIORITY|Non-Inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.0106|||TWO_SIDED|95.0|-0.039|0.002|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Distance (4m)||0.002|-0.039|
73826235|NCT04794751|147198989|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.0127|||TWO_SIDED|95.0|-0.032|0.018|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Intermediate (64cm)||0.018|-0.032|
73826236|NCT04794751|147198989|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.0124|||TWO_SIDED|95.0|-0.034|0.015|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Near (40cm)||0.015|-0.034|
73826237|NCT04794751|147198990|NON_INFERIORITY|Non-inferiority was declared if the lower limit of the 95% confidence interval for the least-square mean difference was greater than -5.|least-square mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.34|||TWO_SIDED|95.0|-4.6|4.8|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|||4.8|-4.6|
73826238|NCT02360488|147198991|NON_INFERIORITY|The trial aimed to establish comparable efficacy based upon a non-inferiority margin of 30% of the change in Fugl-Meyer score in the In-Clinic group. Under these assumptions at alpha=0.05 and assuming SD=3.8 points, 124 subjects would need to be enrolled to provide 85% power; this sample was pursued independent of subject dropouts.|Mean Difference (Net)|0.06||||0.96|TWO_SIDED|95.0|-2.14|2.26|||Regression, Linear|The model was adjusted for study site, age, time post-stroke, stroke subtype, and baseline Fugl-Meyer score.||||2.26|-2.14|.96
73826239|NCT03669588|147198992|SUPERIORITY||Odds Ratio (OR)|4.951|||<|0.0001|TWO_SIDED|95.0|2.213|11.528|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the AChR-Ab seropositive population, stratified by Japanese versus (vs) non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline MG-ADL total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||11.528|2.213|<0.0001
73826240|NCT03669588|147198993|SUPERIORITY||Odds Ratio (OR)|10.842|||<|0.0001|TWO_SIDED|95.0|4.179|31.2|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the AChR-Ab seropositive population, stratified by Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline QMG total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||31.200|4.179|<0.0001
73826241|NCT03669588|147198994|SUPERIORITY||Odds Ratio (OR)|3.699|||<|0.0001|TWO_SIDED|95.0|1.854|7.578|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the overall population, stratified by AChR-Ab status (seropositive vs seronegative), Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline MG-ADL total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||7.578|1.854|<0.0001
73826242|NCT03669588|147198995|SUPERIORITY||Least square means difference|22.065|STANDARD_ERROR_OF_MEAN|5.616||0.0001|TWO_SIDED|95.0|10.949|33.181|||ANCOVA|||Analysis of covariance (ANCOVA) in the AChR-Ab seropositive population with treatment, baseline MG-ADL total score, Japanese vs non-Japanese, and NSID vs no NSID as concomitant gMG treatment as the covariates.||33.181|10.949|0.0001
73826243|NCT03669588|147198996|SUPERIORITY|||||||0.2604|||||||Log Rank|||Analysis was performed in the AChR-Ab seropositive population and the p-value was calculated using the log-rank test, stratified by Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment.||||0.2604
73826244|NCT01721447|147199003|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||< 0.001
73826245|NCT01721447|147199004|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||< 0.001
73826246|NCT00369343|147199005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.32|||<|0.001||95.0|2.53|6.11|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) used baseline as a covariate and factors for center, week and treatment.|DVS SR adjusted mean change minus placebo adjusted mean change.|||6.11|2.53|<0.001
73826247|NCT00369343|147199006|SUPERIORITY_OR_OTHER||||||<|0.001||||||DVS SR compared to Placebo for CGI-I scores of either 1 (very much improved) or 2 (much improved).|Cochran-Mantel-Haenszel|||||||<0.001
73826248|NCT00369343|147199007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.132||||0.008||95.0|1.22|3.74||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odds ratio adjusted for baseline, treatment and site.|||3.74|1.22|0.008
73826249|NCT00369343|147199008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.125|||<|0.001||95.0|1.85|5.27||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odd ratio adjusted for baseline, treatment and site.|||5.27|1.85|<0.001
73826250|NCT00369343|147199009|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.74|||<|0.001||95.0|1.24|4.23||Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.|||4.23|1.24|<0.001
73826251|NCT00369343|147199010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.18|-0.06||Mixed Model Repeated Measures (MMRM) with treatment and site as factors and baseline as covariate.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.|||-0.06|-0.18|<0.001
73826252|NCT00369343|147199017|SUPERIORITY_OR_OTHER|||||||0.553||||||t-test adjusted by multiple comparison|t-test, 2 sided|||100mg vs. Placebo (0mg) post taper||||0.553
73826253|NCT00369343|147199017|SUPERIORITY_OR_OTHER|||||||0.034||||||t-test adjusted by multiple comparison|t-test, 2 sided|||200mg vs. Placebo (0mg) post taper||||0.034
73826254|NCT01100502|147199018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.001|TWO_SIDED|95.0|0.4|0.81|||Log Rank|||||0.81|0.40|0.001
73826255|NCT02322749|147199022|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric Least Squares (LS) Mean Ratio|9.32|||||TWO_SIDED|90.0|8.25|10.53|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||10.53|8.25|
73826256|NCT02322749|147199023|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS Mean Ratio|24.26|||||TWO_SIDED|90.0|22.62|26.03|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||26.03|22.62|
73826257|NCT02322749|147199024|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS mean ratio|22.12|||||TWO_SIDED|90.0|20.65|23.69|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||23.69|20.65|
73826258|NCT02322749|147199025|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|12.93|||||TWO_SIDED|90.0|11.42|14.65|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.65|11.42|
73826259|NCT02322749|147199026|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|26.2|||||TWO_SIDED|90.0|24.44|28.09|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||28.09|24.44|
73826260|NCT02322749|147199027|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|23.6|||||TWO_SIDED|90.0|22.02|25.3|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||25.30|22.02|
73826261|NCT02322749|147199028|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|9.66|||||TWO_SIDED|90.0|8.5|10.97|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect|||10.97|8.5|
73826262|NCT02322749|147199028|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|13.04|||||TWO_SIDED|90.0|11.45|14.86|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.86|11.45|
73826263|NCT02322749|147199029|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|11.31|||||TWO_SIDED|90.0|9.8|13.05|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||13.05|9.80|
73826264|NCT02322749|147199029|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|12.8|||||TWO_SIDED|90.0|11.07|14.8|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.80|11.07|
73826265|NCT04414787|147199062|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-6.21|6.21|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 3 (\~1 week post-randomization)||6.21|-6.21|1.00
73826266|NCT04414787|147199063|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.95|TWO_SIDED|95.0|-1.83|1.72|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||1.72|-1.83|0.95
73826267|NCT04414787|147199064|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.72|TWO_SIDED|95.0|-1.28|1.86|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||1.86|-1.28|0.72
73826268|NCT04414787|147199065|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.48|TWO_SIDED|95.0|-2.44|5.14|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||5.14|-2.44|0.48
73826269|NCT04414787|147199066|SUPERIORITY||Odds Ratio (OR)|0.49||||0.12|TWO_SIDED|95.0|0.2|1.2|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 3 (target \~1 week post-randomization)||1.2|0.20|0.12
73826270|NCT04414787|147199067|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
73826271|NCT04414787|147199068|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
73826272|NCT04414787|147199069|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
73826273|NCT04350827|147199082|SUPERIORITY|||||||0.433|||||||ANOVA|||||||0.433
73826274|NCT03256578|147199103|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
73826275|NCT03256578|147199104|SUPERIORITY|||||||0.107|||||||Wilcoxon (Mann-Whitney)|||||||0.107
73826276|NCT03256578|147199105|SUPERIORITY|||||||0.847|||||||Wilcoxon (Mann-Whitney)|||||||0.847
73826277|NCT03256578|147199106|SUPERIORITY|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
73826278|NCT03256578|147199107|SUPERIORITY|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||||||0.346
73826279|NCT03256578|147199108|SUPERIORITY|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||||||0.094
73826280|NCT03256578|147199109|SUPERIORITY|||||||0.656|||||||Wilcoxon (Mann-Whitney)|||||||0.656
73826281|NCT03256578|147199110|SUPERIORITY|||||||0.434|||||||Wilcoxon (Mann-Whitney)|||||||0.434
73826282|NCT03256578|147199111|SUPERIORITY|||||||0.903|||||||Wilcoxon (Mann-Whitney)|||||||0.903
73826283|NCT03256578|147199112|SUPERIORITY|||||||0.699|||||||Chi-squared|||||||0.699
73826284|NCT03256578|147199113|SUPERIORITY|||||||0.231|||||||Chi-squared|||||||0.231
73826285|NCT03256578|147199114|SUPERIORITY||Risk Ratio (RR)|0.593||||0.283|TWO_SIDED|95.0|0.225|1.561|||Chi-squared|||||1.561|0.225|0.283
73826286|NCT03256578|147199115|SUPERIORITY||Risk Ratio (RR)|1.864||||0.168|TWO_SIDED|95.0|0.756|4.599|||Chi-squared|||||4.599|0.756|0.168
73826287|NCT03256578|147199116|SUPERIORITY||Risk Ratio (RR)|0.67||||0.024|TWO_SIDED|95.0|0.474|0.947|||Chi-squared|||||0.947|0.474|0.024
73826288|NCT03256578|147199117|SUPERIORITY|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
73826289|NCT03256578|147199118|SUPERIORITY|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||||||0.342
73826290|NCT03256578|147199119|SUPERIORITY|||||||0.431|||||||Wilcoxon (Mann-Whitney)|||||||0.431
73826291|NCT03256578|147199121|SUPERIORITY||Risk Ratio (RR)|1.059||||0.518|TWO_SIDED|95.0|0.854|1.313|||Chi-squared|||||1.313|0.854|0.518
73826292|NCT03256578|147199122|SUPERIORITY||Risk Ratio (RR)|0.951||||0.855|TWO_SIDED|95.0|0.555|1.629|||Chi-squared|||||1.629|0.555|0.855
73826293|NCT03256578|147199123|SUPERIORITY||Risk Ratio (RR)|0.994||||0.524|TWO_SIDED|95.0|0.834|1.186|||Chi-squared|||||1.186|0.834|0.524
73826294|NCT03256578|147199124|SUPERIORITY||Risk Ratio (RR)|0.649||||0.28|TWO_SIDED|95.0|0.294|1.434|||Chi-squared|||||1.434|0.294|0.280
73826295|NCT03256578|147199125|SUPERIORITY||Risk Ratio (RR)|1.393||||0.339|TWO_SIDED|95.0|0.703|2.76|||Chi-squared|||||2.760|0.703|0.339
73826296|NCT03256578|147199126|SUPERIORITY|||||||0.486|||||||Chi-squared|||||||0.486
73826297|NCT03256578|147199127|SUPERIORITY|||||||0.655|||||||Chi-squared|||||||0.655
73826298|NCT03256578|147199128|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.99|1.02|||Chi-squared|||||1.02|0.99|1.00
73826299|NCT03028142|147199129|OTHER||LS Means ratio|1.05||||0.0022|TWO_SIDED|95.0|1.02|1.09|||ANCOVA|||||1.09|1.02|0.0022
73826300|NCT03028142|147199129|OTHER||LS Means ratio|1.09|||<|0.0001|TWO_SIDED|95.0|1.05|1.12|||ANCOVA|||||1.12|1.05|<0.0001
73826301|NCT03028142|147199130|OTHER||LS Means ratio|1.03||||0.0988|TWO_SIDED|95.0|0.99|1.06|||ANCOVA|||||1.06|0.99|0.0988
73826302|NCT03028142|147199130|OTHER||LS Means ratio|1.06||||0.0009|TWO_SIDED|95.0|1.02|1.09|||ANCOVA|||||1.09|1.02|0.0009
73826303|NCT03028142|147199131|OTHER||LS Means ratio|1.02||||0.2496|TWO_SIDED|95.0|0.98|1.06|||ANCOVA|||||1.06|0.98|0.2496
73826304|NCT03028142|147199131|OTHER||LS Means ratio|1.06||||0.0039|TWO_SIDED|95.0|1.02|1.1|||ANCOVA|||||1.1|1.02|0.0039
73826305|NCT03028142|147199132|OTHER||LS Means ratio|1.03||||0.1404|TWO_SIDED|95.0|0.99|1.06|||ANCOVA|||||1.06|0.99|0.1404
73826306|NCT03028142|147199132|OTHER||LS Means ratio|1.04||||0.0228|TWO_SIDED|95.0|1.01|1.08|||ANCOVA|||||1.08|1.01|0.0228
73826307|NCT02860988|147199187|OTHER|Two-sided tests versus a margin|Mean Difference (Net)|0.6||||0.29|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.29
73826308|NCT02860988|147199188|OTHER|Two-sided tests versus a margin|Risk Difference (RD)|0.9||||0.88|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.88
73826309|NCT02860988|147199189|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|0.96||||0.89|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.89
73826310|NCT02860988|147199190|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|-4.26||||0.61|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.61
73826311|NCT02860988|147199191|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|3.61||||0.67|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.67
73826312|NCT02860988|147199192|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|5.23||||0.14|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.14
73826313|NCT02860988|147199193|OTHER|Two-sided tests versus a margin.|Mean Difference (Net)|0.03||||0.81|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.81
73826314|NCT02860988|147199194|OTHER|Two-sided tests versus a margin.|Mean Difference (Net)|0.31||||0.74|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.74
73826315|NCT01674725|147199230|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%.|Planned enrollment is 210 to allow ≥200 GT1b-infected participants to be treated with combination formulation of ABT-450/r/ABT-267 and ABT-333 with and without RBV. Enrollment terminated after 187 participants were randomized. Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have \>90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.||100.0|95.9|
73826316|NCT01674725|147199230|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|97.7|||||TWO_SIDED|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have \>90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.||100.0|94.6|
73826317|NCT01674725|147199231|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
73826318|NCT01674725|147199232|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|97.7|||||TWO_SIDED|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|||100.0|94.6|
73826319|NCT01674725|147199232|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority|||100|95.9|
73826320|NCT01674725|147199232|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% confidence interval for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Percentage of Participants|2.3|||||TWO_SIDED|95.0|-0.8|5.4|||||95% CI was calculated using the normal approximation to the binomial distribution.|||5.4|-0.8|
73826321|NCT02900352|147199235|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.0130
73826322|NCT02900352|147199236|SUPERIORITY|||||||0.148|||||||Chi-squared|||||||0.148
73826323|NCT02900352|147199237|SUPERIORITY|||||||0.054|||||||ANOVA|||||||.054
73826324|NCT02900352|147199238|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
73826325|NCT02900352|147199239|SUPERIORITY|||||||0.889|||||||ANOVA|||||||0.889
73826326|NCT02900352|147199240|SUPERIORITY|||||||0.482|||||||ANOVA|||||||0.482
73826327|NCT02900352|147199241|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
73826328|NCT03074695|147199242|OTHER||Risk Difference (RD)|3.03||||0.766|TWO_SIDED|95.0|-14.02|20.08|||Regression, Logistic|Adjusted for baseline characteristics (parturient race, ethnicity, height, and induction status).||||20.08|-14.02|0.766
73826329|NCT01774981|147199252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0449|||||||t-test, 1 sided|||||||0.0449
73826330|NCT01774981|147199252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0808|||||||t-test, 1 sided|||||||0.0808
73826331|NCT01774981|147199252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2219|||||||t-test, 1 sided|||||||0.2219
73826332|NCT01239797|147199259|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0014|TWO_SIDED|95.0|0.6|0.89|||Log Rank|2-sided p-value for stratified log rank test||Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||0.89|0.60|0.0014
73826333|NCT01239797|147199260|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0005|TWO_SIDED|95.0|0.6|0.87|||Log Rank|2-sided p-value for stratified log rank test||Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||0.87|0.60|0.0005
73826334|NCT01239797|147199261|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0002|TWO_SIDED|95.0|1.36|2.78|||Cochran-Mantel-Haenszel|Stratified by B2 microglobulin (\<3.5 mg/L vs \>=3.5 mg/L), number of prior lines of therapy (1 vs \>=2), and immunomodulatory drug use at randomization||Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||2.78|1.36|0.0002
73826335|NCT01239797|147199261|SUPERIORITY||Difference in ORR|12.7|||||TWO_SIDED|95.0|6.2|19.3||||||Difference of Lenalidomide + Dexamethasone + Elotuzumab minus Lenalidomide + Dexamethasone computed using the method of DerSimonian and Laird (weighted average over the strata)||19.3|6.2|
73826336|NCT02631941|147199266|EQUIVALENCE|For budesonide AUC0-last, the 90% Cls for Z7200 compared with Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80% - 125.00%).|Adjusted geometric means ratio|100.64|||<|0.001|TWO_SIDED|90.0|95.82|105.69|||Mixed Models Analysis|||||105.69|95.82|<0.001
73826337|NCT02631941|147199266|EQUIVALENCE|For budesonide AUC0-last, the 90% Cls for Z7200 compared with Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80% - 125.00%).|Adjusted geometric means ratio|102.11|||<|0.001|TWO_SIDED|90.0|95.55|109.13|||Mixed Models Analysis|||||109.13|95.55|<0.001
73826338|NCT02631941|147199267|EQUIVALENCE|For Formoterol AUC0-last, the 90% Cls for Z7200 compared to Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80.00%, 125.00%).|Adjusted geometric means ratio|87.96||||0.002|TWO_SIDED|90.0|83.31|92.86|||Mixed Models Analysis|||||92.86|83.31|0.002
73826339|NCT02631941|147199267|EQUIVALENCE|For Formoterol AUC0-last, the 90% Cls for Z7200 compared to Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80.00%, 125.00%).|Adjusted geometric means ratio|91.17||||0.005|TWO_SIDED|90.0|83.94|99.04|||Mixed Models Analysis|||||99.04|83.94|0.005
73826340|NCT02631941|147199268|EQUIVALENCE|For Budesonide Cmax, the 90% Cls for Z7200 compared with Symbicort without and with charcoal do not lie entirely within the wider bioequivalence acceptance limits of ( 73.74%, 135.62%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|157.86||||1|TWO_SIDED|90.0|144.12|172.91|||Mixed Models Analysis|||||172.91|144.12|1.00
73826341|NCT02631941|147199268|EQUIVALENCE|For Budesonide Cmax, the 90% Cls for Z7200 compared with Symbicort without and with charcoal do not lie entirely within the wider bioequivalence acceptance limits of ( 73.74%, 135.62%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|166.81||||1|TWO_SIDED|90.0|148.35|187.57|||Mixed Models Analysis|||||187.57|148.35|1.00
73826342|NCT02631941|147199269|EQUIVALENCE|For Formoterol Cmax, the 90% Cl for Z7200 compared to Symbicort without and with charcoal lie entirely within the wider bioequivalence acceptance limits of (77.65%, 128.79%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|85.22||||0.012|TWO_SIDED|90.0|79.66|91.17|||Mixed Models Analysis|||||91.17|79.66|0.012
73826343|NCT02631941|147199269|EQUIVALENCE|For Formoterol Cmax, the 90% Cl for Z7200 compared to Symbicort without and with charcoal lie entirely within the wider bioequivalence acceptance limits of (77.65%, 128.79%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|87.74||||0.02|TWO_SIDED|90.0|81.48|94.47|||Mixed Models Analysis|||||94.47|81.48|0.020
73826344|NCT02915835|147199281|SUPERIORITY|||||||0.7|||||||ANCOVA|||||||0.70
73826345|NCT02915835|147199282|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
73826346|NCT02915835|147199283|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826347|NCT02915835|147199284|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826348|NCT02915835|147199285|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826349|NCT02915835|147199286|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826350|NCT02915835|147199287|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826351|NCT02915835|147199288|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826352|NCT02915835|147199289|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826353|NCT02915835|147199290|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826354|NCT02915835|147199291|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826355|NCT02915835|147199292|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826356|NCT02915835|147199293|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826357|NCT02915835|147199294|SUPERIORITY|||||||0.56|||||||Log Rank|||||||.56
73826358|NCT02915835|147199295|SUPERIORITY|||||||0.35|||||||Log Rank|||||||.35
73826359|NCT02915835|147199297|SUPERIORITY|||||||0.76|||||||ANCOVA|||||||.76
73826360|NCT02915835|147199298|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||.57
73826361|NCT02915835|147199299|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||.40
73826362|NCT02915835|147199300|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||.49
73826363|NCT02915835|147199301|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||.75
73826364|NCT02915835|147199302|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||.41
73826365|NCT02915835|147199303|SUPERIORITY|||||||0.31|||||||ANCOVA|||||||0.31
73826366|NCT02915835|147199304|SUPERIORITY|||||||0.84|||||||ANCOVA|||||||0.84
73826367|NCT02915835|147199305|SUPERIORITY|||||||0.11|||||||ANCOVA|||||||0.11
73826368|NCT02915835|147199306|SUPERIORITY|||||||0.66|||||||ANCOVA|||||||0.66
73826369|NCT02915835|147199307|SUPERIORITY|||||||0.27|||||||ANCOVA|||||||0.27
73826370|NCT02915835|147199308|SUPERIORITY|||||||0.54|||||||ANCOVA|||||||0.54
73826371|NCT02915835|147199309|SUPERIORITY|||||||0.9|||||||ANCOVA|||||||.90
73826372|NCT02915835|147199310|SUPERIORITY|||||||0.68|||||||ANCOVA|||||||.68
73826373|NCT02915835|147199311|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||.25
73826374|NCT02915835|147199312|SUPERIORITY|||||||0.95|||||||ANCOVA|||||||.95
73826375|NCT02915835|147199313|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
73826376|NCT02915835|147199314|SUPERIORITY|||||||0.82|||||||ANCOVA|||||||.82
73826377|NCT02915835|147199315|SUPERIORITY|||||||0.47|||||||ANCOVA|||||||.47
73826378|NCT02915835|147199316|SUPERIORITY|||||||0.35|||||||ANCOVA|||||||0.35
73826379|NCT02915835|147199317|SUPERIORITY|||||||0.84|||||||ANCOVA|||||||0.84
73826380|NCT02915835|147199318|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
73826381|NCT02915835|147199320|SUPERIORITY|||||||0.34|||||||ANCOVA|||||||0.34
73826382|NCT02915835|147199321|SUPERIORITY|||||||0.36|||||||ANCOVA|||||||0.36
73826383|NCT02915835|147199322|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
73826384|NCT02915835|147199323|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
73826385|NCT02915835|147199324|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
73826386|NCT02915835|147199325|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||0.41
73826387|NCT02915835|147199326|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
73826388|NCT02915835|147199327|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
73826389|NCT02915835|147199328|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.75
73826390|NCT02915835|147199329|SUPERIORITY|||||||0.95|||||||ANCOVA|||||||0.95
73826391|NCT02915835|147199330|SUPERIORITY|||||||0.31|||||||ANCOVA|||||||0.31
73826392|NCT02915835|147199331|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
73826393|NCT02915835|147199332|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
73826394|NCT02915835|147199333|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
73826395|NCT02915835|147199334|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73826396|NCT02915835|147199335|SUPERIORITY|||||||0.73|||||||ANCOVA|||||||0.73
73826397|NCT02915835|147199336|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
73826398|NCT02915835|147199337|SUPERIORITY|||||||0.45|||||||ANCOVA|||||||0.45
73826399|NCT02915835|147199338|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.58
73826400|NCT02915835|147199339|SUPERIORITY|||||||0.39|||||||ANCOVA|||||||0.39
73826401|NCT02915835|147199340|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
73826402|NCT02513550|147199351|SUPERIORITY||Risk Difference (RD)|7.9|||=|0.005|TWO_SIDED||||||Regression, Logistic|||||||=0.005
73826403|NCT02513550|147199351|SUPERIORITY||Risk Difference (RD)|1.9|||=|0.522|TWO_SIDED||||||Regression, Logistic|||||||=0.522
73826404|NCT02513550|147199352|SUPERIORITY||Risk Difference (RD)|6.9|||=|0.006|TWO_SIDED||||||Regression, Logistic|||||||=0.006
73826405|NCT02513550|147199352|SUPERIORITY||Risk Difference (RD)|4.6|||=|0.118|TWO_SIDED||||||Regression, Logistic|||||||=0.118
73826406|NCT00113607|147199403|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.79||||0.019|TWO_SIDED|95.0|0.65|0.96|||Log Rank|||||0.96|0.65|0.0190
73826407|NCT00113607|147199404|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.86||||0.0835|TWO_SIDED|95.0|0.72|1.02|||Log Rank|||||1.02|0.72|0.0835
73826408|NCT00113607|147199405|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.646||||0.008|TWO_SIDED|95.0|1.144|2.367|||Fisher Exact|||||2.367|1.144|0.0080
73826409|NCT00113607|147199406|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.95||||0.8203|TWO_SIDED|95.0|0.62|1.46|||Log Rank|||||1.46|0.62|0.8203
73826410|NCT01418339|147199424|SUPERIORITY||Treatment Difference|-4.63|||=|0.0028|TWO_SIDED|95.0|-7.62|-1.63||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||-1.63|-7.62|=0.0028
73826411|NCT01418339|147199425|SUPERIORITY||Treatment Difference|-0.52|||=|0.0124|TWO_SIDED|95.0|-0.93|-0.12||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||-0.12|-0.93|=0.0124
73826412|NCT01418339|147199426|SUPERIORITY||Treatment Difference|-2.0|||=|0.5317|TWO_SIDED|95.0|-8.31|4.32||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||4.32|-8.31|=0.5317
73826413|NCT01663402|147199488|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0003|TWO_SIDED|95.0|0.78|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world).||0.93|0.78|0.0003
73826414|NCT01663402|147199489|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0013|TWO_SIDED|95.0|0.81|0.95||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region(North America,South America,Western Europe,Eastern Europe,Asia, Rest of the world).A hierarchical testing approach was used to control the overall type-I error at 0.0249 one-sided alpha level(0.0498 two-sided).Testing was then performed sequentially in the order endpoints were reported.Hierarchical testing sequence continued only if the previous endpoint was statistically significant.||0.95|0.81|0.0013
73826415|NCT01663402|147199490|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.006|TWO_SIDED|95.0|0.8|0.96||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.96|0.80|0.0060
73826416|NCT01663402|147199491|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0003|TWO_SIDED|95.0|0.81|0.94||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.94|0.81|0.0003
73826417|NCT01663402|147199492|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0003|TWO_SIDED|95.0|0.79|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.93|0.79|0.0003
73826418|NCT01663402|147199493|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3824|TWO_SIDED|95.0|0.76|1.11||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||1.11|0.76|0.3824
73826419|NCT00678418|147199503|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Van der Waerden|||Null hypothesis = the distribution function of opioid-free weeks is the same for both treatment groups.||||0.0002
73826420|NCT00678418|147199504|SUPERIORITY_OR_OTHER|||||||0.0042||95.0||||A total of 114 subjects continued on-study beyond the 168-day endpoint for Part A; these subjects were censored as of the first dosing day in Part B.|Kaplan Meier|||P-value was calculated using the log-rank test for the null hypothesis: the distribution of days to discontinuation does not differ by treatment.||||0.0042
73826421|NCT00678418|147199505|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Chi-squared|||"P-value was calculated using the Chi-square test for the null hypothesis: mean treatment difference = 0.~Calculations were based on the Generalized Estimating Equation (GEE) model (normal distribution, identity link and AR(1) correlation structure) for repeated data on change from baseline with treatment and visit as main effects, and baseline as a covariate. Missing data were imputed using the Last Observation Carried Forward (LOCF) method."||||<0.0001
73826422|NCT00678418|147199506|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.0154||95.0|0.6|0.95|||Chi-squared|||"Chi-square test was used to calculate the p-value for treatment. Null hypothesis = no association between relapse to dependence and study treatment.~Subjects who discontinued prematurely from the study were imputed as having a positive naloxone challenge test result."||0.95|0.60|0.0154
73826423|NCT00678418|147199507|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||van der Waerden|||Null hypothesis: Treatment difference=0. Missing data from subjects due to early discontinuation during Part A were imputed using the baseline rate; thus data for subjects who discontinued early were imputed as having no change from baseline.||||0.0031
73826424|NCT03924323|147199511|SUPERIORITY||least squares mean difference|-1.42||||0.0281|TWO_SIDED|95.0|-2.69|-0.15|||mixed-effects model for repeated measure|||||-0.15|-2.69|0.0281
73826425|NCT03924323|147199512|SUPERIORITY||Odds Ratio (OR)|1.253||||0.4521|TWO_SIDED|95.0|0.695|2.258|||generalized linear mixed model (GLMMIX)|||||2.258|0.695|0.4521
73826426|NCT03924323|147199513|SUPERIORITY||Odds Ratio (OR)|1.157||||0.6928|TWO_SIDED|95.0|0.56|2.387|||generalized linear mixed model (GLMMIX)|||||2.387|0.560|0.6928
73826427|NCT02984982|147199540|SUPERIORITY||LS mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.36||0.2279|TWO_SIDED|95.0|-4.32|1.04||Threshold for significance at 0.05 level.|ANCOVA||Standard of Care vs Alirocumab|Analysis was performed using ANCOVA model which included fixed categorical effects of treatment arm and randomization strata, as well as the continuous fixed covariate of baseline normalized TAV.||1.04|-4.32|0.2279
73826428|NCT01103323|147199575|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.774||||0.005178||95.0|0.636|0.942||According to protocol specified O'Brien-Fleming type alpha spending function and 432 death events at 2nd IA, the pre-specified alpha (false positive rate) for this analysis was 0.009279 (1-sided).|Log Rank||Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.|Sample size based on primary efficacy endpoint of OS. The study was designed to have 90% power to detect 33.3% increase in median OS (i.e. hazard ratio of 0.75, Regorafenib / Placebo). Assuming 1-sided overall alpha of 0.025, randomization ratio of 2:1 for Regorafenib and Placebo, and 2 formal interim analyses of OS using an O'Brien-Fleming-type error spending function, a total of 582 death events were required for primary completion. Results based on 2nd planned formal IA with 432 total events.||0.942|0.636|0.005178
73826429|NCT01103323|147199576|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.494|||<|1e-06||95.0|0.419|0.582||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Log Rank||Hazard ratio (Regorafenib / Placebo)|Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.||0.582|0.419|<0.000001
73826430|NCT01103323|147199577|SUPERIORITY_OR_OTHER||Difference|-0.6||||0.188432||95.0|-1.74|0.53||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.||0.53|-1.74|0.188432
73826431|NCT01103323|147199578|SUPERIORITY_OR_OTHER||Difference|-25.94|||<|1e-06||95.0|-32.06|-19.82||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.||-19.82|-32.06|<0.000001
73826432|NCT00767572|147199591|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance threshold p\<0.05|t-test, 2 sided|||Null hypothesis: pre-post brachial artery diameter changes do not differ between placebo and atorvastatin||||>0.05
73826433|NCT01939314|147199625|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5|||||TWO_SIDED|95.0|-13.0|27.1||||||||27.1|-13.0|
73826434|NCT01939314|147199627|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.7|||||TWO_SIDED|95.0|2.6|43.6||||||||43.6|2.6|
73826435|NCT02563899|147199661|SUPERIORITY_OR_OTHER||Percent difference in treatment|-1.0|||||TWO_SIDED|95.0|-42.2|39.9||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD Vs Vehicle: \<=-30%||39.9|-42.2|
73826436|NCT02563899|147199661|SUPERIORITY_OR_OTHER||Percent difference in treatment|1.0|||||TWO_SIDED|95.0|-39.9|42.2||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD vs Vehicle: \<=-50%||42.2|-39.9|
73826437|NCT02563899|147199661|SUPERIORITY_OR_OTHER||Percent difference in treatment|9.0|||||TWO_SIDED|95.0|-25.2|44.0||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD Vs Vehicle: \<=-70%||44.0|-25.2|
73826438|NCT02563899|147199663|SUPERIORITY_OR_OTHER||Percent difference in treatment|27.0|||||TWO_SIDED|95.0|-8.5|62.6||||||||62.6|-8.5|
73826439|NCT00794664|147199664|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C was approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Enrollment was to be conducted such that at least 51 patients were randomized to allow for potential exclusions from an analysis set.||||<0.001
73826440|NCT00794664|147199666|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
73826441|NCT00794664|147199668|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided|||||||<0.001
73826442|NCT00794664|147199670|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided|||||||<0.001
73826443|NCT00794664|147199672|SUPERIORITY_OR_OTHER|||||||0.034||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.034
73826444|NCT00794664|147199674|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.001
73826445|NCT00794664|147199676|SUPERIORITY_OR_OTHER||||||<|0.032||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.032
73826446|NCT00794664|147199678|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||<0.001
73826447|NCT00794664|147199680|SUPERIORITY_OR_OTHER|||||||0.278||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.278
73826448|NCT00794664|147199682|SUPERIORITY_OR_OTHER|||||||0.647||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.647
73826449|NCT01062308|147199684|SUPERIORITY_OR_OTHER||Mean difference from baseline to day 30|-11.8||||0.03|TWO_SIDED|95.0|-22.6|-1.1|||Mixed Models Analysis|||||-1.1|-22.6|0.03
73826450|NCT01062308|147199685|SUPERIORITY_OR_OTHER||Mean difference from baseline to day 30|6.6||||0.16|TWO_SIDED|95.0|-2.7|15.9|||Mixed Models Analysis|||||15.9|-2.7|0.16
73826451|NCT00457730|147199686|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||||||0.016
73826452|NCT00457730|147199687|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
73826453|NCT00457730|147199688|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||t-test, 2 sided|||||||0.074
73826454|NCT00922636|147199723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.74||||0.008||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.|||||0.008
73826455|NCT00922636|147199723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.04||||0.006||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Value is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.|||||0.006
73826456|NCT00922636|147199726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.938||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.||||0.938
73826457|NCT00922636|147199726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.44||||0.002||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.||||0.002
73826458|NCT03268343|147199798|SUPERIORITY||Geometric LS Mean Ratio (%)|74.71|||||TWO_SIDED|90.0|66.39|84.08|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||84.08|66.39|
73826459|NCT03268343|147199799|SUPERIORITY||Geometric LS Mean Ratio (%)|97.04|||||TWO_SIDED|90.0|94.2|99.98|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||99.98|94.20|
73826460|NCT03268343|147199800|SUPERIORITY||Median Difference (Final Values)|1.38|||<|0.0001|TWO_SIDED|95.0|0.5|2.25|||Wilcoxon Signed-Rank test||Hodges-Lehmann method|||2.25|0.50|< 0.0001
73826461|NCT03268343|147199801|SUPERIORITY||Geometric LS Mean Ratio (%)|96.52|||||TWO_SIDED|90.0|93.3|99.85|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||99.85|93.30|
73826462|NCT03268343|147199805|SUPERIORITY||Geometric LS Mean Ratio (%)|104.75|||||TWO_SIDED|95.0|98.97|110.87|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||110.87|98.97|
73826463|NCT00496769|147199815|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|1e-05|TWO_SIDED|95.0|0.32|0.62|||Log Rank|||||0.62|0.32|<0.00001
73826464|NCT00496769|147199816|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.00026|TWO_SIDED|95.0|0.53|0.83|||Log Rank||Vascular death|||0.83|0.53|0.00026
73826465|NCT00496769|147199817|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.06782|TWO_SIDED|95.0|0.62|1.02|||Log Rank||All-cause death|||1.02|0.62|0.06782
73826466|NCT00496769|147199817|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0028|TWO_SIDED|95.0|0.6|0.9|||Log Rank||Composite endpoint of major vascular events and major bleeding-net clinical benefit|||0.90|0.60|0.00280
73826467|NCT00496769|147199817|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.36586|TWO_SIDED|95.0|0.65|1.17|||Log Rank||Vascular death|||1.17|0.65|0.36586
73826468|NCT00496769|147199818|OTHER||Hazard Ratio (HR)|1.54||||0.0716|TWO_SIDED|95.0|0.96|2.45|||Log Rank||Major bleeding|||2.45|0.96|0.0716
73826469|NCT00496769|147199818|OTHER||Hazard Ratio (HR)|1.3||||0.0017|TWO_SIDED|95.0|1.1|1.53|||Log Rank||All bleeding|||1.53|1.10|0.0017
73826470|NCT00496769|147199818|OTHER||Hazard Ratio (HR)|1.38||||0.0144|TWO_SIDED|95.0|1.07|1.78|||Log Rank||Major or CNRM bleeding|||1.78|1.07|0.0144
73826471|NCT00496769|147199819|OTHER||Hazard Ratio (HR)|1.3||||0.0017|TWO_SIDED|95.0|1.1|1.53|||Log Rank|||||1.53|1.10|0.0017
73826472|NCT02812186|147199829|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73826473|NCT02812186|147199830|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
73826474|NCT02812186|147199831|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
73826475|NCT01307787|147199841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.002
73826476|NCT01307787|147199842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.47
73826477|NCT01307787|147199843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.24
73826478|NCT01307787|147199844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.16
73826479|NCT01307787|147199845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.21
73826480|NCT01307787|147199846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.07
73826481|NCT01307787|147199847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.4
73826482|NCT01307787|147199848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.6
73826483|NCT01573000|147199849|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|95.0|35.0|65.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||65|35|
73826484|NCT01573000|147199849|SUPERIORITY_OR_OTHER||percentage of participants|22.0|||||TWO_SIDED|95.0|9.0|36.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||36|9|
73826485|NCT01573000|147199850|SUPERIORITY_OR_OTHER||percentage of participants|16.0|||||TWO_SIDED|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) before Crossover.|||32|0|
73826486|NCT01573000|147199850|SUPERIORITY_OR_OTHER||percentage of participants|79.0|||||TWO_SIDED|95.0|61.0|97.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) after Crossover.|||97|61|
73826487|NCT01573000|147199851|SUPERIORITY_OR_OTHER||percentage of participants|26.0|||||TWO_SIDED|95.0|13.0|39.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||39|13|
73826488|NCT01573000|147199851|SUPERIORITY_OR_OTHER||percentage of participants|8.0|||||TWO_SIDED|95.0|0.0|17.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||17|0|
73826489|NCT01573000|147199852|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Fisher Exact|||||||0.012
73826490|NCT01573000|147199853|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed complete response before Crossover.|||0|0|
73826491|NCT01573000|147199853|SUPERIORITY_OR_OTHER||percentage of participants|42.0|||||TWO_SIDED|95.0|20.0|64.0|||||The estimated value represents the percentage of participants with confirmed complete response after Crossover.|||64|20|
73826492|NCT01573000|147199854|SUPERIORITY_OR_OTHER||percentage of participants|2.0|||||TWO_SIDED|95.0|0.0|7.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||7|0|
73826493|NCT01573000|147199854|SUPERIORITY_OR_OTHER||percentage of participants|3.0|||||TWO_SIDED|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||8|0|
73826494|NCT01573000|147199855|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CCR before Crossover.|||0|0|
73826495|NCT01573000|147199855|SUPERIORITY_OR_OTHER||percentage of participants|5.0|||||TWO_SIDED|95.0|0.0|15.0|||||The estimated value represents the percentage of participants with confirmed CCR after Crossover.|||15|0|
73826496|NCT01573000|147199856|SUPERIORITY_OR_OTHER||percentage of participants|31.0|||||TWO_SIDED|95.0|17.0|45.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||45|17|
73826497|NCT01573000|147199856|SUPERIORITY_OR_OTHER||percentage of participants|11.0|||||TWO_SIDED|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||21|1|
73826498|NCT01573000|147199857|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR before Crossover.|||0|0|
73826499|NCT01573000|147199857|SUPERIORITY_OR_OTHER||percentage of participants|47.0|||||TWO_SIDED|95.0|25.0|70.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR after Crossover.|||70|25|
73826500|NCT01573000|147199858|SUPERIORITY_OR_OTHER||percentage of participants|17.0|||||TWO_SIDED|95.0|5.0|28.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||28|5|
73826501|NCT01573000|147199858|SUPERIORITY_OR_OTHER||percentage of participants|11.0|||||TWO_SIDED|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||21|1|
73826502|NCT01573000|147199859|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
73826503|NCT01573000|147199861|SUPERIORITY_OR_OTHER|||||||0.495||95.0|||||Log Rank|||||||0.495
73826504|NCT01573000|147199862|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Log Rank|||||||0.677
73826505|NCT01573000|147199865|SUPERIORITY_OR_OTHER|||||||0.119||95.0|||||Log Rank|||||||0.119
73826506|NCT01573000|147199866|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Log Rank|||||||0.016
73826507|NCT01573000|147199879|SUPERIORITY_OR_OTHER||percentage of participants|16.0|||||TWO_SIDED|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed PR before Crossover.|||32|0|
73826508|NCT01573000|147199879|SUPERIORITY_OR_OTHER||percentage of participants|32.0|||||TWO_SIDED|95.0|11.0|52.0|||||The estimated value represents the percentage of participants with confirmed PR after Crossover.|||52|11|
73826509|NCT01507181|147199922|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 2 sided|||||||0.32
73826510|NCT01507181|147199923|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
73826511|NCT01507181|147199924|SUPERIORITY_OR_OTHER|||||||0.17||||||Statistics are calculated by comparing 24-h scores using separate ANCOVAs and controlling for baseline severity.|ANCOVA|||||||0.17
73826512|NCT01926028|147199967|EQUIVALENCE|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.39||||0.03|TWO_SIDED|95.0|0.17|0.91|||Wilcoxon (Mann-Whitney)|||||0.91|0.17|0.03
73826513|NCT01926028|147199968|EQUIVALENCE|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.55||||0.1|TWO_SIDED|95.0|0.27|1.13|||Wilcoxon (Mann-Whitney)|||||1.13|0.27|0.10
73826514|NCT01130272|147199977|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.457||||0.052|TWO_SIDED|95.0|0.994|6.077|||ANCOVA|||||6.077|0.994|0.052
73826515|NCT01130272|147199977|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.383||||0.041|TWO_SIDED|95.0|1.036|5.478|||ANCOVA|||||5.478|1.036|0.041
73826516|NCT01130272|147199977|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.079||||0.09|TWO_SIDED|95.0|0.893|4.842|||ANCOVA|||||4.842|0.893|0.090
73826517|NCT01130272|147199977|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.797||||0.015|TWO_SIDED|95.0|1.227|6.376|||ANCOVA|||||6.376|1.227|0.015
73826518|NCT01130272|147199978|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.719||||0.449|TWO_SIDED|95.0|0.306|1.689|||ANCOVA|||||1.689|0.306|0.449
73826519|NCT01130272|147199978|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.208||||0.583|TWO_SIDED|95.0|0.615|2.373|||ANCOVA|||||2.373|0.615|0.583
73826520|NCT01130272|147199978|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.014||||0.03|TWO_SIDED|95.0|1.069|3.795|||ANCOVA|||||3.795|1.069|0.030
73826521|NCT01130272|147199978|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.395||||0.326|TWO_SIDED|95.0|0.717|2.716|||ANCOVA|||||2.716|0.717|0.326
73826522|NCT00641056|147199992|NON_INFERIORITY_OR_EQUIVALENCE|Power: 205 patients per treatment group would provide approximately 92% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.|Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|-0.29|-0.03||No adjustments for multiplicity were performed|Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects. Superiority of exenatide once weekly to insulin glargine is concluded if the upper limit of the 95% confidence interval for the treatment difference \[exenatide once weekly-insulin glargine\]\<0; noninferiority is concluded if this upper limit\<0.3%.||-0.03|-0.29|0.017
73826523|NCT00641056|147199993|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|95.0||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<=7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and country served as the stratification factors.||||0.097
73826524|NCT00641056|147199994|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<=6.5% at Week 26 were compared between treatments using a CMH test, in which background OAD and country served as the stratification factors.||||0.002
73826525|NCT00641056|147199995|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|0.25|1.0||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in FSG as the dependent variable; treatment, baseline FSG, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||1.00|0.25|0.001
73826526|NCT00641056|147199996|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.05|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-4.57|-3.52||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in BW as the dependent variable; treatment, baseline BW, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||-3.52|-4.57|<.001
73826527|NCT00641056|147199997|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.292|TWO_SIDED|95.0|-0.21|0.06||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in total cholesterol as the dependent variable; treatment, baseline total cholesterol, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||0.06|-0.21|0.292
73826528|NCT00641056|147199998|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.377|TWO_SIDED|95.0|-0.05|0.02||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in HDL as the dependent variable; treatment, baseline HDL, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||0.02|-0.05|0.377
73826529|NCT00641056|147199999|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.07|STANDARD_ERROR_OF_MEAN|0.04||0.077|TWO_SIDED|95.0|0.99|1.15||No adjustments for multiplicity were performed|Mixed Models Analysis|||Triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed by MMRM ANCOVA with change in triglycerides as the dependent variable; treatment, baseline triglycerides, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||1.15|0.99|0.077
73826530|NCT00737048|147200002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_DEVIATION|8.06|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 1 for Total pain relief based on numerical rating scale score||||<0.0001
73826531|NCT00737048|147200002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|STANDARD_DEVIATION|7.99|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 2 for Total pain relief based on numerical rating scale score||||<0.0001
73826532|NCT02351934|147200014|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.564
73826533|NCT02351934|147200015|SUPERIORITY|||||||0.675|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.675
73826534|NCT02351934|147200016|SUPERIORITY|||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.125
73826535|NCT02351934|147200018|SUPERIORITY|||||||0.595|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.595
73826536|NCT02351934|147200019|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.985
73826537|NCT01115452|147200029|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.32||||0.9347|TWO_SIDED|95.0|-8.14|7.5||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis was no difference between treatments.||7.50|-8.14|0.9347
73826538|NCT01115452|147200030|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02||||0.9963|TWO_SIDED|95.0|-8.2|8.24||Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.24|-8.20|0.9963
73826539|NCT01115452|147200030|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.9||||0.3582|TWO_SIDED|95.0|-4.45|12.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.25|-4.45|0.3582
73826540|NCT01115452|147200030|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.88||||0.36|TWO_SIDED|95.0|-4.46|12.22||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.22|-4.46|0.3600
73826541|NCT01115452|147200031|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.91||||0.8265|TWO_SIDED|95.0|-9.13|7.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.30|-9.13|0.8265
73826542|NCT01115452|147200031|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9||||0.8314|TWO_SIDED|95.0|-9.25|7.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.45|-9.25|0.8314
73826543|NCT01115452|147200031|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01||||0.9978|TWO_SIDED|95.0|-8.33|8.35||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.35|-8.33|0.9978
73826544|NCT01115452|147200032|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.22||||0.3122|TWO_SIDED|95.0|-4.0|12.44|||ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.44|-4.00|0.3122
73826545|NCT01115452|147200032|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.27||||0.7646|TWO_SIDED|95.0|-9.62|7.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.08|-9.62|0.7646
73826546|NCT01115452|147200032|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.49||||0.1957||95.0|-13.83|2.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||2.85|-13.83|0.1957
73826547|NCT01115452|147200033|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.35||||0.7472|TWO_SIDED|95.0|-9.62|6.92||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.92|-9.62|0.7472
73826548|NCT01115452|147200033|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.66||||0.8767||95.0|-7.75|9.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.||9.08|-7.75|0.8767
73826549|NCT01115452|147200033|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.01||||0.6367||95.0|-6.39|10.42||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.42|-6.39|0.6367
73826550|NCT01115452|147200034|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.95||||0.6417|TWO_SIDED|95.0|-10.22|6.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.32|-10.22|0.6417
73826551|NCT01115452|147200034|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.43||||0.92|TWO_SIDED|95.0|-7.99|8.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.85|-7.99|0.9200
73826552|NCT01115452|147200034|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.38||||0.5766||95.0|-6.02|10.78||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.78|-6.02|0.5766
73826553|NCT01115452|147200035|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.58||||0.393|TWO_SIDED|95.0|-11.65|4.68||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||4.68|-11.65|0.3930
73826554|NCT01115452|147200035|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7||||0.6896|TWO_SIDED|95.0|-10.12|6.71||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.71|-10.12|0.6896
73826555|NCT01115452|147200035|SUPERIORITY_OR_OTHER||Adjustes mean difference|1.88||||0.6591|TWO_SIDED|95.0|-6.52|10.28||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.28|-6.52|0.6591
73826556|NCT01115452|147200036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.08||||0.6301||95.0|-10.6|6.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.45|-10.60|0.6301
73826557|NCT01115452|147200036|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.76||||0.6888|TWO_SIDED|95.0|-10.46|6.93||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.93|-10.46|0.6888
73826558|NCT01115452|147200036|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.32||||0.9428|TWO_SIDED|95.0|-8.37|9.0||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.00|-8.37|0.9428
73826559|NCT01115452|147200037|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.58||||0.5504|TWO_SIDED|95.0|-11.1|5.95||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||5.95|-11.10|0.5504
73826560|NCT01115452|147200037|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1||||0.634|TWO_SIDED|95.0|-10.8|6.6||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.60|-10.80|0.6340
73826561|NCT01115452|147200037|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.48||||0.9127|TWO_SIDED|95.0|-8.2|9.16|||ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.16|-8.20|0.9127
73826562|NCT01115452|147200038|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.15||||0.6192|TWO_SIDED|95.0|-10.67|6.38||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.38|-10.67|0.6192
73826563|NCT01115452|147200038|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.6||||0.8912|TWO_SIDED|95.0|-8.1|9.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.30|-8.10|0.8912
73826564|NCT01115452|147200038|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.75||||0.5321|TWO_SIDED|95.0|-5.93|11.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution|Null hypothesis is no difference between treatments.||11.43|-5.93|0.5321
73826565|NCT01115452|147200039|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.37||||0.4055|TWO_SIDED|95.0|-11.37|4.63||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||4.63|-11.37|0.4055
73826566|NCT01115452|147200039|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.74||||0.8573|TWO_SIDED|95.0|-7.42|8.91||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.91|-7.42|0.8573
73826567|NCT01115452|147200039|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.12||||0.3193|TWO_SIDED|95.0|-4.03|12.27||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.27|-4.03|0.3193
73826568|NCT01115452|147200040|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.23||||0.4264||95.0|-4.77|11.23||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||11.23|-4.77|0.4264
73826569|NCT01115452|147200040|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.04||||0.8008|TWO_SIDED|95.0|-7.42|9.21||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.||9.21|-7.42|0.8008
73826570|NCT01115452|147200040|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.18||||0.5969|TWO_SIDED|95.0|-10.33|5.97||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||5.97|-10.33|0.5969
73826571|NCT01115452|147200041|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.14||||0.2059|TWO_SIDED|95.0|-13.14|2.86||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||2.86|-13.14|0.2059
73826572|NCT01115452|147200041|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39||||0.9248|TWO_SIDED|95.0|-8.56|7.77||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.77|-8.56|0.9248
73826573|NCT01115452|147200041|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.75||||0.2508|TWO_SIDED|95.0|-3.4|12.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.90|-3.40|0.2508
73826574|NCT01115452|147200042|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.12||||0.7822|TWO_SIDED|95.0|-6.86|9.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.10|-6.86|0.7822
73826575|NCT01115452|147200042|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.44||||0.7208|TWO_SIDED|95.0|-6.52|9.41||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.41|-6.52|0.7208
73826576|NCT01115452|147200043|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.36||||0.7318|TWO_SIDED|95.0|-9.18|6.46||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.46|-9.18|0.7318
73826577|NCT01115452|147200043|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.05||||0.7949|TWO_SIDED|95.0|-6.93|9.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.03|-6.93|0.7949
73826578|NCT01115452|147200043|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.41||||0.5507|TWO_SIDED|95.0|-5.56|10.37||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.37|-5.56|0.5507
73826579|NCT01115452|147200044|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72||||0.8549|TWO_SIDED|95.0|-8.54|7.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Investigator applied the participants with 5% potassium nitrate solution on each of the three individual sensitive tooth for two minutes (mins), in each of the five day treatment period|Null hypothesis is no difference between treatments.||7.10|-8.54|0.8549
73826580|NCT01115452|147200044|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.15||||0.9705|TWO_SIDED|95.0|-8.13|7.83||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.83|-8.13|0.9705
73826581|NCT01115452|147200044|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.57||||0.8867|TWO_SIDED|95.0|-7.39|8.54||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.54|-7.39|0.8867
73826582|NCT00752089|147200121|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.146||||0.7756|TWO_SIDED|95.0|-6.904|9.196||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||9.196|-6.904|0.7756
73826583|NCT00752089|147200121|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.291||||0.4194|TWO_SIDED|95.0|-4.84|11.421||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||11.421|-4.840|0.4194
73826584|NCT00752089|147200121|SUPERIORITY_OR_OTHER||Adjusted mean difference|22.2|||<|0.0001|TWO_SIDED|95.0|14.28|30.12||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||30.120|14.280|<0.0001
73826585|NCT00752089|147200121|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.145||||0.5927|TWO_SIDED|95.0|-5.874|10.164||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||10.164|-5.874|0.5927
73826586|NCT00752089|147200121|SUPERIORITY_OR_OTHER||Adjusted mean difference|21.054|||<|0.0001|TWO_SIDED|95.0|13.189|28.919||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||28.919|13.189|<0.0001
73826587|NCT00752089|147200121|SUPERIORITY_OR_OTHER||Adjusted mean difference|18.909|||<|0.0001|TWO_SIDED|95.0|11.036|26.783||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||26.783|11.036|<0.0001
73826588|NCT00752089|147200122|SUPERIORITY_OR_OTHER||Adjusted mean difference|-321.438||||0.199|TWO_SIDED|95.0|-818.118|175.242||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||175.242|-818.118|0.1990
73826589|NCT00752089|147200122|SUPERIORITY_OR_OTHER||Adjusted mean difference|-72.68||||0.7718||95.0|-574.398|429.039||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||429.039|-574.398|0.7718
73826590|NCT00752089|147200122|SUPERIORITY_OR_OTHER||Adjusted mean difference|1784.675|||<|0.0001||95.0|1296.044|2273.306||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2273.306|1296.044|<0.0001
73826591|NCT00752089|147200122|SUPERIORITY_OR_OTHER||Adjusted mean difference|248.758||||0.3164||95.0|-245.962|743.478||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included tratment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||743.478|-245.962|0.3164
73826592|NCT00752089|147200122|SUPERIORITY_OR_OTHER||Adjusted mean difference|2106.113|||<|0.0001|TWO_SIDED|95.0|1620.906|2591.32||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2591.320|1620.906|<0.0001
73826593|NCT00752089|147200122|SUPERIORITY_OR_OTHER||Adjusted mean difference|1857.355|||<|0.0001|TWO_SIDED|95.0|1371.637|2343.072||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period and fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2343.072|1371.637|<0.0001
73826594|NCT01324102|147200123|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|95.0||||The a priori threshold for statistical significance is .05. The .004 value exceeds this value. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row and category of anxiety.|ANOVA|F=10.25||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing anxiety scores pre-Yoga versus post-Yoga, between the two groups for changes in anxiety.||||.004
73826595|NCT01324102|147200123|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||F=4.07. The a priori threshold for statistical significance is .05. The .056 value does not exceed it. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row/category of insomnia.|ANOVA|||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing insomnia scores pre-Yoga versus post-Yoga, between the two groups. This measures changes in insomnia.||||.056
73826596|NCT00386334|147200132|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
73826597|NCT00386334|147200135|SUPERIORITY_OR_OTHER|||||||0.0014||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0014
73826598|NCT00386334|147200138|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
73826599|NCT00386334|147200141|SUPERIORITY_OR_OTHER|||||||0.0005||||||Multiple comparisons not applied due to only two treatments in study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0005
73826600|NCT00386334|147200144|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
73826601|NCT00386334|147200147|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
73826602|NCT00386334|147200150|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
73826603|NCT00386334|147200153|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
73826604|NCT00386334|147200156|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
73826605|NCT00386334|147200159|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
73826606|NCT00386334|147200162|SUPERIORITY_OR_OTHER|||||||0.1175||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.1175
73826607|NCT00386334|147200165|SUPERIORITY_OR_OTHER|||||||0.0717||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0717
73826608|NCT00386334|147200168|SUPERIORITY_OR_OTHER|||||||0.1182||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|||||||0.1182
73826609|NCT00386334|147200171|SUPERIORITY_OR_OTHER|||||||0.301||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.3010
73826610|NCT00386334|147200174|SUPERIORITY_OR_OTHER|||||||0.78||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.7800
73826611|NCT00386334|147200177|SUPERIORITY_OR_OTHER|||||||0.0803||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0803
73826612|NCT00386334|147200180|SUPERIORITY_OR_OTHER|||||||0.2643||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.2643
73826613|NCT00386334|147200183|SUPERIORITY_OR_OTHER|||||||0.0765||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0765
73826614|NCT00386334|147200186|SUPERIORITY_OR_OTHER|||||||0.2967||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.2967
73826615|NCT00386334|147200189|SUPERIORITY_OR_OTHER|||||||0.0634||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0634
73826616|NCT00386334|147200192|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
73826617|NCT03843372|147200201|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The AHI was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare AHI between CPAP and HFNC||||<0.001
73826618|NCT03843372|147200202|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The oxygen desaturation index was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare oxygen desaturation index between CPAP and HFNC||||<0.001
73826619|NCT03843372|147200203|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The total sleep time was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare total sleep time between CPAP and HFNC||||<0.001
73826620|NCT03843372|147200204|SUPERIORITY|||||||0.008|||||||Wilcoxon rank sum test|||The sleep efficiency was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare sleep efficiency between CPAP and HFNC||||0.008
73826621|NCT00902577|147200205|OTHER||Hazard Ratio (HR)|1.54||||0.048|TWO_SIDED|95.0|1.0|2.36|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.:~This marker was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||2.36|1.0|0.048
73826622|NCT00902577|147200205|OTHER||Hazard Ratio (HR)|1.16||||0.5|TWO_SIDED|95.0|0.75|1.81|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for OS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported. The study was designed to enroll 46 evaluable participants to detect a log hazard ratio of 1.279 for TBmax with HV as a covariate with a 50% event rate||1.81|.75|0.50
73826623|NCT00902577|147200205|OTHER||Hazard Ratio (HR)|1.0||||0.9|TWO_SIDED|0.97|0.97|1.03|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.03|0.97|0.90
73826624|NCT00902577|147200205|OTHER||Hazard Ratio (HR)|1.17||||0.024|TWO_SIDED|95.0|1.02|1.34|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model Mean ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.34|1.02|0.024
73826625|NCT00902577|147200205|OTHER||Hazard Ratio (HR)|1.32||||0.045|TWO_SIDED|95.0|1.01|1.72|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.72|1.01|0.045
73826626|NCT00902577|147200205|OTHER||Hazard Ratio (HR)|1.11||||0.31|TWO_SIDED|95.0|0.9|1.37|||Regression, Cox|||Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.37|0.90|0.31
73826627|NCT00902577|147200205|OTHER||Hazard Ratio (HR)|1.07||||0.51|TWO_SIDED|95.0|0.88|1.29|||Regression, Cox|||cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion nCBF was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.29|0.88|0.51
73826628|NCT00902577|147200205|OTHER||Hazard Ratio (HR)|1.0||||0.97|TWO_SIDED|95.0|0.79|1.26|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the lower ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.26|0.79|0.9700
73826629|NCT00902577|147200205|OTHER||Hazard Ratio (HR)|0.99||||0.9007|TWO_SIDED|95.0|0.91|1.09|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the higher ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.09|0.91|0.9007
73826630|NCT00902577|147200206|OTHER||Hazard Ratio (HR)|1.24||||0.33|TWO_SIDED|95.0|0.8|1.91|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~This marker was modeled with a univariate Cox regression model for Progression Free Survival time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.91|.80|0.33
73826631|NCT00902577|147200206|OTHER||Hazard Ratio (HR)|0.93||||0.72|TWO_SIDED|95.0|0.61|1.4|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.4|.61|0.72
73826632|NCT00902577|147200206|OTHER||Hazard Ratio (HR)|1.01||||0.355|TWO_SIDED|95.0|0.98|1.04|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.04|.98|0.355
73826633|NCT00902577|147200206|OTHER||Hazard Ratio (HR)|1.1||||0.074|TWO_SIDED|95.0|0.99|1.23|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.23|0.99|0.074
73826634|NCT00902577|147200206|OTHER||Hazard Ratio (HR)|1.3||||0.021|TWO_SIDED|95.0|1.04|1.63|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.63|1.04|0.021
73826635|NCT00902577|147200206|OTHER||Hazard Ratio (HR)|1.28||||0.0096|TWO_SIDED|95.0|1.06|1.54|||Regression, Cox|||"Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for PFS time.~The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.54|1.06|0.0096
73826636|NCT00902577|147200206|OTHER||Hazard Ratio (HR)|1.18||||0.038|TWO_SIDED|95.0|1.01|1.38|||Regression, Cox|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion.~nCBF was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.38|1.01|0.038
73826637|NCT00902577|147200206|OTHER||Odds Ratio (OR)|0.682||||0.3253|TWO_SIDED|95.0|0.318|1.463|||Regression, Logistic|||Logistic regression for SUVpeak to predict PFS6||1.463|0.318|0.3253
73826638|NCT00902577|147200206|OTHER||Odds Ratio (OR)|0.991||||0.9836|TWO_SIDED|95.0|0.403|2.434|||Regression, Logistic|||TBmax was modeled with a univariate logistic regression model for PFS6.||2.434|0.403|0.9836
73826639|NCT00902577|147200206|OTHER||Odds Ratio (OR)|0.957||||0.1566|TWO_SIDED|95.0|0.9|1.017|||Regression, Logistic|||Hypoxic Volume (HV) was modeled with a logistic regression model for 6month progression free survival (PFS6) .||1.017|0.900|0.1566
73826640|NCT00902577|147200206|OTHER||Odds Ratio (OR)|0.993||||0.9554|TWO_SIDED|95.0|0.775|1.273|||Regression, Logistic|||"Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate logistic regression model for PFS6."||1.273|0.775|0.9554
73826641|NCT00902577|147200206|OTHER||Odds Ratio (OR)|0.919||||0.6941|TWO_SIDED|95.0|0.602|1.402|||Regression, Logistic|||"Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate logistic regression model for PFS6"||1.402|0.602|0.6941
73826642|NCT00902577|147200206|OTHER||Odds Ratio (OR)|0.744||||0.134|TWO_SIDED|95.0|0.506|1.095|||Regression, Logistic|||"Relative cerebral blood volume (RCBV) maps were corrected for leakage effects and normalized to normal appearing white matter (nRCBV).~nRCBV was modeled with a univariate logistic regression model for PFS6."||1.095|0.506|0.1340
73826643|NCT00902577|147200206|OTHER||Odds Ratio (OR)|0.821||||0.2642|TWO_SIDED|95.0|0.58|1.161|||Regression, Logistic|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF.~nCBF was modeled with a univariate logistic regression model for PFS6."||1.161|0.580|0.2642
73826644|NCT00902577|147200206|OTHER||Odds Ratio (OR)|0.855||||0.5069|TWO_SIDED|95.0|0.539|1.357|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) low values were modeled with a univariate logistic regression model for PFS6||1.357|0.539|0.5069
73826645|NCT00902577|147200206|OTHER||Odds Ratio (OR)|0.884||||0.1921|TWO_SIDED|95.0|0.735|1.064|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) high values were modeled with a univariate Logistic regression model for PFS6||1.064|0.735|0.1921
73826646|NCT00902577|147200206|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.61|||||TWO_SIDED|95.0|0.42|0.79||||||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.79|0.42|
73826647|NCT00902577|147200206|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.59|||||TWO_SIDED|95.0|0.39|0.78||||||"T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.78|0.39|
73826648|NCT00902577|147200206|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||TWO_SIDED|95.0|0.46|0.83||||||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.83|0.46|
73826649|NCT00902577|147200206|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.62|||||TWO_SIDED|95.0|0.42|0.83||||||"mean ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of mean ktrans to predict PFS9."||0.83|0.42|
73826650|NCT00902577|147200206|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||TWO_SIDED|95.0|0.44|0.84||||||"Median ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of Median ktrans to predict PFS9."||0.84|0.44|
73826651|NCT00902577|147200206|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.54|0.89||||||nRCBV provides a measure of tumor vasculature Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.||0.89|0.54|
73826652|NCT00902577|147200206|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.55|0.89||||||nCBF provides a measure of vascular permeability and perfusion. Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.||0.89|0.55|
73826653|NCT02337062|147200216|SUPERIORITY||||||<|0.001||||||The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test.||||<0.001
73826654|NCT02337062|147200217|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
73826655|NCT02337062|147200218|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
73826656|NCT02337062|147200219|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
73826657|NCT02337062|147200220|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73826658|NCT02337062|147200221|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
73826659|NCT03238417|147200251|NON_INFERIORITY|Analysis of Variance comparing change in outcome between EBQI and control from baseline to 12 month.|Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|1.32||0.623|TWO_SIDED|95.0|-3.3|2.0||P-value is from the interaction term between EBQI and time.|ANOVA|||||2.0|-3.3|0.623
73826660|NCT03238417|147200252|NON_INFERIORITY|Analysis of Variance testing for change in outcome between EBQI and control from baseline to 24 months.|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|1.1||0.678|TWO_SIDED|95.0|-2.8|1.8||P-value is from the interaction term of EBQI and time.|ANOVA|||||1.8|-2.8|0.678
73826661|NCT03238417|147200253|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.364|TWO_SIDED|95.0|-0.17|0.35||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Linear||The estimated value reported here is the predicted mean change from baseline to 12-month, adjusting for characteristics described in the statistical analysis overview.|Change in gender awareness score between EBQI and control from baseline to 12-month||0.35|-0.17|0.364
73826662|NCT03238417|147200254|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.29|TWO_SIDED|95.0|-0.33|0.1||P-value reflects the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Linear||The estimated value reported here is the predicted mean change from baseline to 24-month, adjusting for characteristics described in the statistical analysis overview.|Change in gender awareness score between EBQI and control from baseline to 24-month||0.10|-0.33|0.29
73826663|NCT03238417|147200255|SUPERIORITY|Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.|Odds Ratio (OR)|-0.69|STANDARD_ERROR_OF_MEAN|0.42||0.1|TWO_SIDED|95.0|-1.52|0.13||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Difference-in-Differences analysis||The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.|||0.13|-1.52|0.10
73896539|NCT03456882|147326406|SUPERIORITY||difference between mean slopes|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5728|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the off-treatment follow-up period (change per week, from week 24 to week 48) between treatment groups. Null hypothesis: the rate of change from week 24 to week 48 is not different between groups.||||0.5728
73826664|NCT03238417|147200256|SUPERIORITY|Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.|Odds Ratio (OR)|-0.48|STANDARD_ERROR_OF_MEAN|0.39||0.22|TWO_SIDED|95.0|-1.25|0.29||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Logistic||The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.|||0.29|-1.25|0.22
73826665|NCT03238417|147200257|NON_INFERIORITY|Analysis of Variance testing the differences in outcome between EBQI and control groups over 12 month period.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|3.1||0.788|TWO_SIDED|95.0|-7.1|5.4||The p-value reflects the interaction term between EBQI and time|ANOVA|||||5.4|-7.1|0.788
73826666|NCT03238417|147200258|NON_INFERIORITY|Analysis of Variance testing for differences in outcomes between EBQI and control arms from baseline to 24 months.|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|2.89||0.61|TWO_SIDED|95.0|-7.35|4.35||The p-value reflects the interaction terms between EBQI and control arms.|ANOVA|||||4.35|-7.35|0.61
73826667|NCT03238417|147200259|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control arms|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|10.5||0.987|TWO_SIDED|95.0|-21.45|21.11||The p-value reflects the interaction term between EBQI and time|ANOVA|||||21.11|-21.45|0.987
73826668|NCT03238417|147200260|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|-3.91|STANDARD_ERROR_OF_MEAN|10.35||0.708|TWO_SIDED|95.0|-24.89|17.08||The p-value reflects the interaction terms between EBQI and time|ANOVA|||||17.08|-24.89|0.708
73826669|NCT03238417|147200261|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|-4.51|STANDARD_ERROR_OF_MEAN|8.85||0.613|TWO_SIDED|95.0|-22.43|13.4||The p-value reflects the interaction term between EBQI and time|ANOVA|||||13.40|-22.43|0.613
73826670|NCT03238417|147200262|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|9.48||0.922|TWO_SIDED|95.0|-18.26|20.13||The p-value reflects the interaction term between EBQI and time.|ANOVA|||||20.13|-18.26|0.922
73826671|NCT03238417|147200263|NON_INFERIORITY|two-way ANOVA testing change in a composite score of gender-neutral preventive care between EBQI and control arms over time|Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|2.13||0.789|TWO_SIDED|95.0|-3.74|4.89||The p-value represents the interaction term between EBQI and control.|ANOVA|||||4.89|-3.74|0.789
73826672|NCT03238417|147200264|NON_INFERIORITY|ANOVA comparing changes in outcomes over time between EBQI and control groups|Mean Difference (Net)|-1.63|STANDARD_ERROR_OF_MEAN|2.45||0.51|TWO_SIDED|95.0|-6.6|3.33||The p-value reflects the interaction between EBQI and time.|ANOVA|The analysis is adjusted for EBQI and time.||||3.33|-6.60|0.51
73826673|NCT03238417|147200265|NON_INFERIORITY|ANOVA testing for change in outcome over time between EBQI and control arms|Mean Difference (Net)|3.11|STANDARD_ERROR_OF_MEAN|8.3||0.711|TWO_SIDED|95.0|-13.7|19.9||The p-value reflects the interaction between EBQI and time|ANOVA|||||19.9|-13.7|0.711
73826674|NCT03238417|147200266|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control arms|Mean Difference (Net)|8.49|STANDARD_ERROR_OF_MEAN|8.7||0.335|TWO_SIDED|95.0|-9.1|26.1||The p-value reflects the interaction term between EBQI and time.|ANOVA|||||26.1|-9.1|0.335
73826675|NCT03238417|147200267|NON_INFERIORITY|Analysis of Variance testing for change in outcome between EBQI and control groups from baseline to 12 months.|Mean Difference (Net)|-13.8|STANDARD_ERROR_OF_MEAN|12.3||0.268|TWO_SIDED|95.0|-38.7|11.1||P-value is from the interaction term between EBQI and time.|ANOVA|||||11.1|-38.7|0.268
73826676|NCT03238417|147200268|NON_INFERIORITY|Analysis of Variance testing the differences between EBQI and control from baseline and 24 months|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|12.6||0.991|TWO_SIDED|95.0|-25.6|25.3||P-value is from the interaction between EBQI and time.|ANOVA|||||25.3|-25.6|0.991
73826677|NCT00501631|147200301|SUPERIORITY_OR_OTHER|||||||0.336||95.0|||||Van der Waerden test|||The null hypothesis that there is no difference between two treatment groups (i.e. Placebo and Vivitrol) was tested using a two-sided Van der Waerden test. Response profiles were tabulated as a cumulative percent of subjects at each decile of percent heavy drinking days.||||0.336
73826678|NCT04456686|147200315|SUPERIORITY||Posterior Mean Difference|-0.03|||||TWO_SIDED|95.0|-0.77|0.7|||Bayesian Mixed Model Analysis|||||0.70|-0.77|
73826679|NCT04456686|147200316|SUPERIORITY||Posterior Mean Difference|0.58|||||TWO_SIDED|95.0|-0.82|1.96|||Bayesian Mixed Model Analysis|||||1.96|-0.82|
73826680|NCT04456686|147200317|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.45|0.63|||Bayesian Mixed Model Analysis|||||0.63|-0.45|
73826681|NCT04456686|147200318|SUPERIORITY||Posterior Mean Difference|0.9|||||TWO_SIDED|95.0|-3.31|5.06|||Bayesian Mixed Model Analysis|||||5.06|-3.31|
73826682|NCT04456686|147200319|SUPERIORITY||Posterior Mean Difference|0.03|||||TWO_SIDED|95.0|-0.46|0.5|||Bayesian Mixed Model Analysis|||||0.50|-0.46|
73826683|NCT04456686|147200320|SUPERIORITY||Posterior Mean Difference|0.11|||||TWO_SIDED|95.0|-0.72|0.91|||Bayesian Mixed Model Analysis|||||0.91|-0.72|
73826684|NCT04456686|147200321|SUPERIORITY||Posterior Mean Difference|2.45|||||TWO_SIDED|95.0|-7.27|12.2|||Bayesian Mixed Model Analysis|||||12.20|-7.27|
73826685|NCT04456686|147200322|SUPERIORITY||Posterior Mean Difference|0.4|||||TWO_SIDED|95.0|-0.04|0.85|||Bayesian Mixed Model Analysis|||||0.85|-0.04|
73826686|NCT04456686|147200323|SUPERIORITY||Posterior Mean Difference|168.61|||||TWO_SIDED|95.0|-38.22|379.2|||Bayesian Mixed Model Analysis|||||379.20|-38.22|
73826687|NCT04456686|147200324|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.07|0.06|||Bayesian Mixed Model Analysis|||||0.06|-0.07|
73826688|NCT01329198|147200336|SUPERIORITY||Mean Difference (Final Values)|-17.8|STANDARD_DEVIATION|9.4||0.013|TWO_SIDED||||||ANOVA||Mean change in YGTSS scores from Baseline to 6 Months across all study participants presented.|||||0.013
73826689|NCT00473083|147200338|SUPERIORITY_OR_OTHER|||||||0.8769||||||P for arm 1 v arms 2 and 3 combined|Chi-squared|||||||0.8769
73826690|NCT00473083|147200338|SUPERIORITY_OR_OTHER|||||||0.147||||||P for arm 1 v arms 2 and 3 combined|Wilcoxon (Mann-Whitney)|||||||0.147
73826691|NCT00473083|147200339|SUPERIORITY_OR_OTHER|||||||0.1503||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.1503
73826692|NCT00473083|147200339|SUPERIORITY_OR_OTHER|||||||0.4681||||||P(arm2 v arm3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.4681
73826693|NCT00473083|147200339|SUPERIORITY_OR_OTHER|||||||0.0196||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.0196
73826694|NCT00473083|147200339|SUPERIORITY_OR_OTHER|||||||0.1658||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)|||||||0.1658
73826695|NCT00473083|147200339|SUPERIORITY_OR_OTHER||||||>|0.9999||||||"P(arm 2 v arm 3) in patients with maximum severity of rash grade 3.~P-value was calculated to be \>0.9999 using the Wilcoxon Rank Sumtest by comparing between the two treatment arms."|Wilcoxon (Mann-Whitney)|||||||>0.9999
73826696|NCT00473083|147200339|SUPERIORITY_OR_OTHER|||||||0.285||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)|||||||0.285
73826697|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.5097|||||||Chi-squared|||Maximal Rash Grade 1||||0.5097
73826698|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.474|||||||Chi-squared|||Maximal Rash Grade 2a||||0.4740
73826699|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.2123|||||||Chi-squared|||Maximal Severity Grade 2b||||0.2123
73826700|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.5004|||||||Chi-squared|||Maximal Severity Grade 3||||0.5004
73826701|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.9072|||||||Chi-squared|||Maximal Severity Grade 1||||0.9072
73826702|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.0464|||||||Chi-squared|||Maximal Severity Grade 2a||||0.0464
73826703|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.6759|||||||Chi-squared|||Maximal Severity Grade 2b||||0.6759
73826704|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.0065|||||||Chi-squared|||Maximal Severity Grade 3||||0.0065
73826705|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.5898|||||||Chi-squared|||Maximal Severity Grade 1||||0.5898
73826706|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.1921|||||||Chi-squared|||Maximal Severity Grade 2a||||0.1921
73826707|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.0882|||||||Chi-squared|||Maximal Severity Grade 2b||||0.0882
73826708|NCT00473083|147200340|SUPERIORITY_OR_OTHER|||||||0.0344|||||||Chi-squared|||Maximal Severity Grade 3||||0.0344
73826709|NCT00473083|147200341|SUPERIORITY_OR_OTHER|||||||0.3834|||||||Log Rank|||||||0.3834
73826710|NCT00473083|147200343|SUPERIORITY_OR_OTHER|||||||0.0147|||||||Wilcoxon (Mann-Whitney)|||||||0.0147
73826711|NCT02858401|147200346|OTHER|||||||0.1498|||||||Wilcoxon rank sum test|||||||0.1498
73826712|NCT02858401|147200346|OTHER|||||||0.064|||||||Wilcoxon rank sum test|||||||0.0640
73826713|NCT02858401|147200346|OTHER|||||||0.2807|||||||Wilcoxon rank sum test|||||||0.2807
73826714|NCT02858401|147200346|OTHER|||||||0.1228|||||||Wilcoxon rank sum test|||||||0.1228
73826715|NCT02858401|147200346|OTHER|||||||0.0289|||||||Wilcoxon rank sum test|||||||0.0289
73826716|NCT02858401|147200346|OTHER|||||||0.5895|||||||Wilcoxon rank sum test|||||||0.5895
73826717|NCT02858401|147200347|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826718|NCT02858401|147200347|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826719|NCT02858401|147200347|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826720|NCT02858401|147200348|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
73826721|NCT02858401|147200348|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
73826722|NCT02858401|147200348|OTHER|||||||0.8288|||||||Wilcoxon rank sum test|||||||0.8288
73826723|NCT02858401|147200348|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
73826724|NCT02858401|147200348|OTHER|||||||0.6056|||||||Wilcoxon rank sum test|||||||0.6056
73826725|NCT02858401|147200348|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
73826726|NCT02858401|147200349|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826727|NCT02858401|147200349|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826728|NCT02858401|147200349|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826729|NCT02858401|147200350|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826730|NCT02858401|147200350|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826731|NCT02858401|147200350|OTHER|||||||0.1556|||||||Wilcoxon rank sum test|||||||0.1556
73826732|NCT02858401|147200350|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826733|NCT02858401|147200350|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826734|NCT02858401|147200350|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826735|NCT02858401|147200351|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826736|NCT02858401|147200351|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826737|NCT02858401|147200351|OTHER|||||||0.3613|||||||Wilcoxon rank sum test|||||||0.3613
73826738|NCT02858401|147200352|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826739|NCT02858401|147200352|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826740|NCT02858401|147200352|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
73826741|NCT02858401|147200352|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826742|NCT02858401|147200352|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826743|NCT02858401|147200352|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826744|NCT02858401|147200353|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826745|NCT02858401|147200353|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826746|NCT02858401|147200353|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826747|NCT02858401|147200354|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826748|NCT02858401|147200354|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826749|NCT02858401|147200354|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826750|NCT02858401|147200355|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826751|NCT02858401|147200355|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826752|NCT02858401|147200355|OTHER|||||||0.1556|||||||Wilcoxon rank sum test|||||||0.1556
73826753|NCT02858401|147200355|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826754|NCT02858401|147200355|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826755|NCT02858401|147200355|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826756|NCT02858401|147200356|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826757|NCT02858401|147200356|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826758|NCT02858401|147200356|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826759|NCT02858401|147200357|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
73826760|NCT02858401|147200357|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826761|NCT02858401|147200357|OTHER|||||||0.4278|||||||Wilcoxon rank sum test|||||||0.4278
73826762|NCT02858401|147200357|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826763|NCT02858401|147200357|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826764|NCT02858401|147200357|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826765|NCT02858401|147200358|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
73826766|NCT02858401|147200358|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
73826767|NCT02858401|147200358|OTHER|||||||0.1869|||||||Wilcoxon rank sum test|||||||0.1869
73826768|NCT02858401|147200358|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
73826769|NCT02858401|147200358|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
73826770|NCT02858401|147200359|OTHER|||||||0.3613|||||||Wilcoxon rank sum test|||||||0.3613
73826771|NCT02858401|147200359|OTHER|||||||0.4237|||||||Wilcoxon rank sum test|||||||0.4237
73826772|NCT02858401|147200359|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
73826773|NCT02858401|147200360|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
73826774|NCT02858401|147200360|OTHER|||||||0.3971|||||||Wilcoxon rank sum test|||||||0.3971
73826775|NCT02858401|147200360|OTHER|||||||0.1301|||||||Wilcoxon rank sum test|||||||0.1301
73826776|NCT02858401|147200360|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
73826777|NCT02858401|147200360|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
73826778|NCT02858401|147200360|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
73826779|NCT02858401|147200361|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826780|NCT02858401|147200361|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
73826781|NCT02858401|147200361|OTHER|||||||0.5993|||||||Wilcoxon rank sum test|||||||0.5993
73826782|NCT02858401|147200362|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826783|NCT02858401|147200362|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826784|NCT02858401|147200362|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
73826785|NCT02858401|147200362|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826786|NCT02858401|147200362|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826787|NCT02858401|147200362|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826788|NCT02858401|147200363|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826789|NCT02858401|147200363|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826790|NCT02858401|147200363|OTHER|||||||0.2763|||||||Wilcoxon rank sum test|||||||0.2763
73826791|NCT02858401|147200363|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826792|NCT02858401|147200363|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826793|NCT02858401|147200364|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826794|NCT02858401|147200364|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826795|NCT02858401|147200364|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826796|NCT02858401|147200365|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826797|NCT02858401|147200365|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826798|NCT02858401|147200365|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
73826799|NCT02858401|147200365|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826800|NCT02858401|147200365|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826801|NCT02858401|147200365|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826802|NCT02858401|147200366|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826803|NCT02858401|147200366|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826804|NCT02858401|147200366|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826805|NCT02858401|147200367|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
73826806|NCT02858401|147200367|OTHER|||||||0.5896|||||||Wilcoxon rank sum test|||||||0.5896
73826807|NCT02858401|147200367|OTHER|||||||0.8207|||||||Wilcoxon rank sum test|||||||0.8207
73826808|NCT02858401|147200367|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
73826809|NCT02858401|147200367|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
73826810|NCT02858401|147200367|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
73826811|NCT02858401|147200368|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826812|NCT02858401|147200368|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826813|NCT02858401|147200368|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826814|NCT02858401|147200369|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
73826815|NCT02858401|147200369|OTHER|||||||0.3755|||||||Wilcoxon rank sum test|||||||0.3755
73826816|NCT02858401|147200369|OTHER|||||||0.4577|||||||Wilcoxon rank sum test|||||||0.4577
73826817|NCT02858401|147200369|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
73826818|NCT02858401|147200369|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
73826819|NCT02858401|147200369|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
73826820|NCT02858401|147200370|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826821|NCT02858401|147200370|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
73826822|NCT02858401|147200370|OTHER|||||||0.7526|||||||Wilcoxon rank sum test|||||||0.7526
73826823|NCT02858401|147200371|OTHER|||||||0.5546|||||||Wilcoxon rank sum test|||||||0.5546
73826824|NCT02858401|147200371|OTHER|||||||0.6937|||||||Wilcoxon rank sum test|||||||0.6937
73826825|NCT02858401|147200371|OTHER|||||||0.8207|||||||Wilcoxon rank sum test|||||||0.8207
73826826|NCT02858401|147200371|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
73826827|NCT02858401|147200371|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
73826828|NCT02858401|147200371|OTHER|||||||0.7878|||||||Wilcoxon rank sum test|||||||0.7878
73826829|NCT02858401|147200372|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826830|NCT02858401|147200372|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826831|NCT02858401|147200372|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826832|NCT02858401|147200373|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826833|NCT02858401|147200373|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826834|NCT02858401|147200373|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826835|NCT02858401|147200373|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826836|NCT02858401|147200373|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
73826837|NCT02858401|147200373|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
73826838|NCT02858401|147200374|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
73826839|NCT02858401|147200374|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
73826840|NCT02858401|147200374|OTHER|||||||0.6908|||||||Wilcoxon rank sum test|||||||0.6908
73826841|NCT02858401|147200374|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
73826842|NCT02858401|147200374|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
73826843|NCT02858401|147200375|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826844|NCT02858401|147200375|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826845|NCT02858401|147200375|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826846|NCT02858401|147200376|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
73826847|NCT02858401|147200376|OTHER|||||||0.5896|||||||Wilcoxon rank sum test|||||||0.5896
73826848|NCT02858401|147200376|OTHER|||||||0.1784|||||||Wilcoxon rank sum test|||||||0.1784
73826849|NCT02858401|147200376|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
73826850|NCT02858401|147200376|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
73826851|NCT02858401|147200376|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
73826852|NCT02858401|147200377|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826853|NCT02858401|147200377|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826854|NCT02858401|147200377|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826855|NCT02858401|147200378|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826856|NCT02858401|147200378|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826857|NCT02858401|147200378|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826858|NCT02858401|147200379|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
73826859|NCT02858401|147200379|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
73826860|NCT02858401|147200380|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826861|NCT02858401|147200380|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826862|NCT02858401|147200380|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826863|NCT02858401|147200381|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
73826864|NCT02858401|147200381|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
73826865|NCT02858401|147200381|OTHER|||||||0.5993|||||||Wilcoxon rank sum test|||||||0.5993
73826866|NCT02858401|147200382|OTHER|||||||0.8504|||||||Wilcoxon rank sum test|||||||0.8504
73826867|NCT02858401|147200382|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
73826868|NCT02858401|147200382|OTHER|||||||0.6908|||||||Wilcoxon rank sum test|||||||0.6908
73826869|NCT02858401|147200382|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
73826870|NCT02858401|147200382|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
73826871|NCT02858401|147200383|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826872|NCT02858401|147200383|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826873|NCT02858401|147200383|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826874|NCT02858401|147200384|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826875|NCT02858401|147200384|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826876|NCT02858401|147200384|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826877|NCT02858401|147200385|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
73826878|NCT02858401|147200385|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
73826879|NCT02858401|147200386|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826880|NCT02858401|147200386|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826881|NCT02858401|147200386|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826882|NCT02858401|147200387|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826883|NCT02858401|147200387|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826884|NCT02858401|147200387|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
73826885|NCT02858401|147200388|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
73826886|NCT02858401|147200388|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
73826887|NCT02858401|147200388|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
73826888|NCT02858401|147200389|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826889|NCT02858401|147200389|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826890|NCT02858401|147200389|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
73826891|NCT02858401|147200390|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826892|NCT02858401|147200390|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
73826893|NCT02858401|147200390|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
73826894|NCT02858401|147200391|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
73826895|NCT02858401|147200391|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
73826896|NCT02858401|147200391|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
73826897|NCT02858401|147200394|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826898|NCT02858401|147200394|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826899|NCT02858401|147200394|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826900|NCT02858401|147200394|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826901|NCT02858401|147200394|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826902|NCT02858401|147200394|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826903|NCT02858401|147200395|OTHER|||||||0.3333|||||||Fisher Exact|||||||0.3333
73826904|NCT02858401|147200396|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826905|NCT02858401|147200396|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826906|NCT02858401|147200396|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826907|NCT02858401|147200396|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826908|NCT02858401|147200396|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826909|NCT02858401|147200396|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826910|NCT02858401|147200397|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826911|NCT02858401|147200397|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826912|NCT02858401|147200397|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826913|NCT02858401|147200397|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826914|NCT02858401|147200397|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826915|NCT02858401|147200397|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826916|NCT02858401|147200398|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826917|NCT02858401|147200398|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826918|NCT02858401|147200398|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826919|NCT02858401|147200399|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826920|NCT02858401|147200399|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826921|NCT02858401|147200399|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826922|NCT02858401|147200401|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826923|NCT02858401|147200401|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826924|NCT02858401|147200401|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73826925|NCT03093181|147200413|SUPERIORITY||Least square (LS) mean difference|3.12||||0.0128|TWO_SIDED|95.0|0.68|5.56||From Analysis of covariance (ANCOVA) with treatment main effect, age stratum and baseline as covariates|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).|||5.56|0.68|0.0128
73826926|NCT03093181|147200413|SUPERIORITY||LS mean difference|1.51||||0.2262|TWO_SIDED|95.0|-0.95|3.96||From ANCOVA with treatment main effect, age stratum and baseline as covariates.|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).|||3.96|-0.95|0.2262
73826927|NCT03093181|147200415|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0243|TWO_SIDED|95.0|1.08|3.15|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.||3.15|1.08|0.0243
73826928|NCT03093181|147200415|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8931|TWO_SIDED|95.0|0.61|1.78|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.||1.78|0.61|0.8931
73826929|NCT03093181|147200415|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0181|TWO_SIDED|95.0|1.12|3.25|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.||3.25|1.12|0.0181
73826930|NCT03093181|147200415|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8319|TWO_SIDED|95.0|0.55|1.63|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.||1.63|0.55|0.8319
73826931|NCT03093181|147200416|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0279|TWO_SIDED|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.||0.28|0.02|0.0279
73826932|NCT03093181|147200416|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.8887|TWO_SIDED|95.0|-0.12|0.14|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.||0.14|-0.12|0.8887
73826933|NCT03093181|147200416|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0224|TWO_SIDED|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.||0.28|0.02|0.0224
73826934|NCT03093181|147200416|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.8253|TWO_SIDED|95.0|-0.15|0.12|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.||0.12|-0.15|0.8253
73826935|NCT04210986|147200420|SUPERIORITY||Odds Ratio (OR)|0.99|||>|0.9|TWO_SIDED|95.0|0.25|4.02||No adjustment made for multiple comparisons.|Fisher Exact||Odds ratio is for fisetin group, relative to the placebo group.|Null hypothesis: no difference in proportion of participants experiencing any TEAE between Fisetin and Placebo groups.||4.02|0.25|>0.9
73826936|NCT04210986|147200421|SUPERIORITY||Contrast of LS Means|-3.5||||0.9728|TWO_SIDED|95.0|-10.6|3.6||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 14 ASSESSMENT Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||3.6|-10.6|0.9728
73826937|NCT04210986|147200421|SUPERIORITY||Contrast of LS Means|-2.5||||0.9728|TWO_SIDED|95.0|-7.8|2.8||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 45 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||2.8|-7.8|0.9728
73826938|NCT04210986|147200421|SUPERIORITY||Contrast of LS Means|-20.5||||0.0829|TWO_SIDED|95.0|-37.7|-3.3||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||-3.3|-37.7|0.0829
73826939|NCT04210986|147200421|SUPERIORITY||Contrast of LS Means|-0.5||||0.9728|TWO_SIDED|95.0||||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Contrast of LS Means|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||||0.9728
73896540|NCT03456882|147326407|SUPERIORITY|||||||0.9212||||||Significance level set to 0.05|Log Rank|||Null hypothesis: the survival curves over the on-treatment and the off-treatment follow-up period are not different between groups.||||0.9212
73826940|NCT04210986|147200422|SUPERIORITY||Contrast of LS Means|2.52|||>|0.99|TWO_SIDED|95.0|-49.4|54.5||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 14 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||54.5|-49.4|>0.99
73826941|NCT04210986|147200422|SUPERIORITY||Contrast of LS Means|11.0|||>|0.99|TWO_SIDED|95.0|-36.8|58.8||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 45 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||58.8|-36.8|>0.99
73826942|NCT04210986|147200422|SUPERIORITY||Contrast of LS Means|-40.3||||0.6594|TWO_SIDED|95.0|-97.6|17.1||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||17.1|-97.6|0.6594
73826943|NCT04210986|147200422|SUPERIORITY||Contrast of LS Means|-6.9|||>|0.99|TWO_SIDED|95.0|-45.5|31.7||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||31.7|-45.5|>0.99
73826944|NCT04210986|147200423|SUPERIORITY||Contrast of LS Means|10.5||||0.748|TWO_SIDED|95.0|-12.9|33.9||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||33.9|-12.9|0.7480
73826945|NCT04210986|147200423|SUPERIORITY||Contrast of LS Means|-0.6||||0.9572|TWO_SIDED|95.0|-22.2|21.1||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||21.1|-22.2|0.9572
73826946|NCT04210986|147200424|SUPERIORITY||Contrast of LS Means|0.01|||>|0.99|TWO_SIDED|95.0|-0.47|0.49||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.49|-0.47|>0.99
73826947|NCT04210986|147200424|SUPERIORITY||Contrast of LS Means|0.07|||>|0.99|TWO_SIDED|95.0|-0.33|0.47||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.47|-0.33|>0.99
73826948|NCT04210986|147200425|SUPERIORITY||Contrast of LS Means|-0.37|||>|0.99|TWO_SIDED|95.0|-1.61|0.87||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.87|-1.61|>0.99
73826949|NCT04210986|147200425|SUPERIORITY||Contrast of LS Means|0.16|||>|0.99|TWO_SIDED|95.0|-0.8|1.13||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.13|-0.80|>0.99
73826950|NCT04210986|147200426|SUPERIORITY||Contrast of LS Means|-0.022||||0.13|TWO_SIDED|95.0|-0.045|0.002||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.002|-0.045|0.130
73826951|NCT04210986|147200426|SUPERIORITY||Contrast of LS Means|-0.024||||0.13|TWO_SIDED|95.0|-0.049|0.002||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.002|-0.049|0.130
73826952|NCT04210986|147200427|SUPERIORITY||Contrast of LS Means|-0.22||||0.9584|TWO_SIDED|95.0|-0.84|0.4||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.40|-0.84|0.9584
73826953|NCT04210986|147200427|SUPERIORITY||Contrast of LS Means|0.12||||0.9584|TWO_SIDED|95.0|-0.69|0.92||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.92|-0.69|0.9584
73826954|NCT04210986|147200428|SUPERIORITY||Contrast of LS Means|1.88||||0.5905|TWO_SIDED|95.0|-5.07|8.84||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||8.84|-5.07|0.5905
73826955|NCT04210986|147200428|SUPERIORITY||Contrast of LS Means|3.86||||0.5414|TWO_SIDED|95.0|-3.08|10.79||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||10.79|-3.08|0.5414
73826956|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|0.05|||>|0.99|TWO_SIDED|95.0|-0.75|0.85||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 3 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.85|-0.75|>0.99
73826957|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|0.44|||>|0.99|TWO_SIDED|95.0|-0.45|1.34||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.34|-0.45|>0.99
73826958|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|0.42|||>|0.99|TWO_SIDED|95.0|-0.7|1.54||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 9 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.54|-0.70|>0.99
73826959|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|-0.06|||>|0.99|TWO_SIDED|95.0|-0.91|0.78||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.78|-0.91|>0.99
73826960|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|-0.47|||>|0.99|TWO_SIDED|95.0|-1.5|0.56||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 15 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.56|-1.50|>0.99
73826961|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|-0.19|||>|0.99|TWO_SIDED|95.0|-1.16|0.77||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 18 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.77|-1.16|>0.99
73826962|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|0.19|||>|0.99|TWO_SIDED|95.0|-0.58|0.96||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 21 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.96|-0.58|>0.99
73826963|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|0.1|||>|0.99|TWO_SIDED|95.0|-0.76|0.97||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 24 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.97|-0.76|>0.99
73826964|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|0.01|||>|0.99|TWO_SIDED|95.0|-0.74|0.76||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 27 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.76|-0.74|>0.99
73826965|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|-0.38|||>|0.99|TWO_SIDED|95.0|-1.2|0.44||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 30 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.44|-1.20|>0.99
73826966|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|0.1|||>|0.99|TWO_SIDED|95.0|-0.69|0.89||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 33 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.89|-0.69|>0.99
73826967|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|-0.2|||>|0.99|TWO_SIDED|95.0|-1.02|0.61||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 36 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.61|-1.02|>0.99
73826968|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|0.11|||>|0.99|TWO_SIDED|95.0|-0.7|0.92||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 39 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.92|-0.70|>0.99
73826969|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|-0.62|||>|0.99|TWO_SIDED|95.0|-1.36|0.13||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 42 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.13|-1.36|>0.99
73826970|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|-0.23|||>|0.99|TWO_SIDED|95.0|-1.01|0.55||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 7 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.55|-1.01|>0.99
73826971|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|-0.2|||>|0.99|TWO_SIDED|95.0|-0.89|0.49||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 8 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.49|-0.89|>0.99
73826972|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|0.02|||>|0.99|TWO_SIDED|95.0|-0.63|0.67||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 9 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.67|-0.63|>0.99
73826973|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|-0.17|||>|0.99|TWO_SIDED|95.0|-0.95|0.61||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 10 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.61|-0.95|>0.99
73826974|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|-0.42|||>|0.99|TWO_SIDED|95.0|-1.18|0.34||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 11 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.34|-1.18|>0.99
73826975|NCT04210986|147200429|SUPERIORITY||Contrast of LS Means|-0.35|||>|0.99|TWO_SIDED|95.0|-1.41|0.71||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.71|-1.41|>0.99
73826976|NCT04210986|147200430|SUPERIORITY||Contrast of LS Means|1.86||||0.9106|TWO_SIDED|95.0|-3.09|6.82||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||6.82|-3.09|0.9106
73826977|NCT04210986|147200430|SUPERIORITY||Contrast of LS Means|-4.2||||0.4424|TWO_SIDED|95.0|-9.93|1.53||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.53|-9.93|0.4424
73826978|NCT04210986|147200430|SUPERIORITY||Contrast of LS Means|-0.03||||0.9901|TWO_SIDED|95.0|-5.55|5.48||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 18 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||5.48|-5.55|0.9901
73826979|NCT04210986|147200431|SUPERIORITY||Contrast of LS Means|0.69|||>|0.99|TWO_SIDED|95.0|-30.95|32.3||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|"MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.~A priori power calculation was based a standardized mean difference effect size of SMD=0.73 (Mackay, et al, 2018, Osteoarthritis and Cartilage)."||32.3|-30.95|>0.99
73826980|NCT04210986|147200431|SUPERIORITY||Contrast of LS Means|-11.3|||>|0.99|TWO_SIDED|95.0|-46.9|24.2||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|"MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.~A priori power calculation was based a standardized mean difference effect size of SMD=0.73 (Mackay, et al, 2018, Osteoarthritis and Cartilage)."||24.2|-46.9|>0.99
73826981|NCT04210986|147200432|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.474|TWO_SIDED|95.0|0.05|4.21||A priori threshold for statistical significance = 0.05.|Log Rank|Cox proportional hazards model constructed. Score (log rank) test to assess between group difference in hazard rate.|Hazard ratio expresses the hazard rate of the Fisetin group in the numerator and the hazard rate of the Placebo group in the denominator|With only 4 participants that converted to an alternative treatment modality, this analysis is underpowered.||4.21|0.05|0.474
73826982|NCT04233879|147200433|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% confidence interval (95%CI) was less than 10 percentage points.|Treatment Difference|0.6|||||TWO_SIDED|95.0|-4.5|5.8|||||Unstratified Miettinen and Nurminen method was used to generate the treatment difference and the associated 95%CI.|||5.8|-4.5|
73826983|NCT04233879|147200434|OTHER|Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)|Percentage Difference|4.3|||||TWO_SIDED|95.0|-0.8|9.6|||||Miettinen \& Nurminen method was used to generate percentage difference and the associated 95%CI.|||9.6|-0.8|
73826984|NCT04233879|147200435|OTHER|Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)|Percentage Difference|4.0|||||TWO_SIDED|95.0|0.4|7.9|||||Miettinen \& Nurminen method was used to generate percentage difference and the associated 95%CI.|||7.9|0.4|
73826985|NCT04233879|147200438|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.|Treatment Difference|2.3|||||TWO_SIDED|95.0|-3.1|7.7|||||Miettinen and Nurminen method was used to generate treatment difference and the associated 95%CI.|||7.7|-3.1|
73826986|NCT04233879|147200439|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.|Treatment Difference|1.0|||||TWO_SIDED|95.0|-4.1|6.1|||||Miettinen and Nurminen method was used to generate treatment difference and the associated 95%CI.|||6.1|-4.1|
73826987|NCT04233879|147200450|SUPERIORITY|Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 0.|Treatment Difference|0.15||||0.73|TWO_SIDED|95.0|-0.71|1.02|||ANCOVA|A 2-sided p-value was calculated using the Analysis of covariance (ANCOVA) model.|ANCOVA model was used to generate treatment difference and the associated 95%CI.|||1.02|-0.71|0.73
73826988|NCT03585270|147200461|SUPERIORITY||Relative Risk Reduction|0.072||||0.7338|TWO_SIDED|95.0|-0.426|0.396|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.2785).|||0.396|-0.426|0.7338
73826989|NCT03585270|147200462|SUPERIORITY||Relative Risk Reduction|0.341||||0.177|TWO_SIDED|95.0|-0.213|0.642|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8644).|||0.642|-0.213|0.177
73826990|NCT03585270|147200463|SUPERIORITY||Relative Risk Reduction|-0.254||||0.1983|TWO_SIDED|95.0|-0.76|0.107|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8844).|||0.107|-0.760|0.1983
73826991|NCT03585270|147200464|SUPERIORITY||Relative Risk Reduction|-0.254||||0.1983|TWO_SIDED|95.0|-0.76|0.107|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8844).|||0.107|-0.760|0.1983
73826992|NCT03585270|147200465|SUPERIORITY||Relative Risk Reduction|0.119||||0.5591|TWO_SIDED|95.0|-0.349|0.425|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.1706).|||0.425|-0.349|0.5591
73826993|NCT03585270|147200466|SUPERIORITY||Relative Risk Reduction|0.267||||0.1179|TWO_SIDED|95.0|-0.085|0.505|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.4580)|||0.505|-0.085|0.1179
73826994|NCT03585270|147200467|SUPERIORITY||Relative Risk Reduction|0.139||||0.5217|TWO_SIDED|95.0|-0.365|0.457|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.1685)|||0.457|-0.365|0.5217
73826995|NCT01076543|147200477|OTHER||Maximum tolerated dose in mg|20.0|||||TWO_SIDED||||||||"The maximum tolerated dose (MTD) was determined using the traditional 3+3 design and was the maximum dose level such that less than 33% of the patients (i.e, \<1 of 3 or \<2 of 6) experience dose-limiting toxicity."|||||
73826996|NCT01076543|147200479|SUPERIORITY||||||>|0.1|||||||Binomial exact test|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.||||>0.10
73826997|NCT01076543|147200479|SUPERIORITY|||||||||||||||||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 50% vs. 70% alternative.|The follicular subgroup did not reach its accrual goal and was closed.|||
73826998|NCT01076543|147200479|SUPERIORITY||||||<|0.1|||||||Binomial exact test.|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.||||<0.10
73826999|NCT05222880|147200482|SUPERIORITY|A superiority Margin of 0.00 logMAR was used for distance.|Mean Population Estimate|-0.1|STANDARD_ERROR_OF_MEAN|0.007|||TWO_SIDED|99.0|-0.12|-0.08||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 17 subjects were required to test the primary hypothesis for Distance.||-0.08|-0.12|
73827000|NCT05222880|147200482|SUPERIORITY|A superiority Margin of 0.17 logMAR was used for Intermediate.|Mean Population Estimate|-0.04|STANDARD_ERROR_OF_MEAN|0.007|||TWO_SIDED|99.0|-0.06|-0.02||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 11 subjects were required to test the primary hypothesis for Intermediate.||-0.02|-0.06|
73827001|NCT05222880|147200482|SUPERIORITY|A superiority Margin of 0.17 logMAR was used for near.|Mean Population Estimate|0.07|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|99.0|0.05|0.09||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 48 subjects were required to test the primary hypothesis for Near.||0.09|0.05|
73827002|NCT05222880|147200483|SUPERIORITY|A superiority Margin of 36 CLUE Points was used for Hyperopes.|Mean Population Estimate|52.3|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|99.0|45.2|59.4||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 14 subjects were required to test for superiority for CLUE vision scores for Hyperopes.||59.4|45.2|
73827003|NCT05222880|147200483|SUPERIORITY|A superiority Margin of 41 CLUE Points was used for Myopes.|Mean Population Estimate|63.3|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|99.0|58.0|68.6||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 18 subjects were required to test for superiority for CLUE vision scores for Myopes.||68.6|58.0|
73827004|NCT05222880|147200484|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Proportion|0.0019|STANDARD_DEVIATION|0.00209|||TWO_SIDED|95.0|0.0|0.0076|||Bayesian beta- binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.||0.0076|0.0000|
73827005|NCT05222880|147200485|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Proportion|0.0018|STANDARD_DEVIATION|0.0021|||TWO_SIDED|95.0|0.0|0.0078|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.||0.0078|0.0000|
73827006|NCT05222880|147200486|SUPERIORITY|A superiority Margin of 41 CLUE Points was used for Hyperopes.|Mean Population Estimate|52.3|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|99.0|45.2|59.4||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 16 subjects were required to test for superiority for CLUE vision scores for Hyperopes.||59.4|45.2|
73827007|NCT05222880|147200486|SUPERIORITY|A superiority Margin of 46 CLUE Points was used for Myopes.|Mean Population Estimate|63.3|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|99.0|58.0|68.6||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 15 subjects were required to test for superiority for CLUE vision scores for Myopes.||68.6|58.0|
73827008|NCT05222880|147200487|SUPERIORITY|A Superiority margin of 52 CLUE points was used|Mean Population Estimate|72.6|STANDARD_ERROR_OF_MEAN|1.763|||TWO_SIDED|99.0|68.1|77.1||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 11 subjects were required to test for superiority for CLUE comfort scores.||77.1|68.1|
73827009|NCT05222880|147200488|SUPERIORITY|A Superiority margin of 53 CLUE points was used|Mean Population Estimate|67.6|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|99.0|63.0|72.1||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 17 subjects were required to test for superiority for CLUE handling scores.||72.1|63.0|
73827010|NCT05222880|147200489|SUPERIORITY|A superiority margin of 0.90 was used.|Mean Posterior Proportion|0.985|STANDARD_DEVIATION|0.0071|||TWO_SIDED|99.0|0.959|0.997|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.98 and an intraclass correlation of 0.70 with 2000 replicating trials, that 92 subjects were required to test for superiority to achieve a minimum statistical power of 80% with 99% central posterior credible.||0.997|0.959|
73827011|NCT01791985|147200491|OTHER||Mean|0.08|STANDARD_DEVIATION|0.32|||TWO_SIDED|||||||||Proportion of change in tumour size at 12 weeks (or progression if prior to week 12), when used in combination with either anastrozole or letrozole in ER positive breast cancer patients who have progressed on treatment with either anastrozole or letrozole in any setting||||
73827012|NCT04232839|147200502|OTHER||Adjusted geometric mean (gMean) ratio(%)|85.9|||||TWO_SIDED|90.0|80.3|91.7|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||91.7|80.3|
73827013|NCT04232839|147200502|OTHER||Adjusted geometric mean (gMean) ratio(%)|72.6|||||TWO_SIDED|90.0|68.0|77.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||77.6|68.0|
73827014|NCT04232839|147200502|OTHER||Adjusted geometric mean (gMean) ratio(%)|92.4|||||TWO_SIDED|90.0|86.5|98.8|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||98.8|86.5|
73827015|NCT04232839|147200502|OTHER||Adjusted geometric mean (gMean) ratio(%)|76.6|||||TWO_SIDED|90.0|71.6|81.8|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||81.8|71.6|
73827016|NCT04232839|147200502|OTHER||Adjusted geometric mean (gMean) ratio(%)|133.4|||||TWO_SIDED|90.0|117.2|151.9|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =17.6.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||151.9|117.2|
73827017|NCT04232839|147200502|OTHER||Adjusted geometric mean (gMean) ratio(%)|114.2|||||TWO_SIDED|90.0|102.3|127.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =16.2.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||127.6|102.3|
73827018|NCT04232839|147200503|OTHER||Adjusted geometric mean (gMean) ratio(%)|85.5|||||TWO_SIDED|90.0|80.0|91.4|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||91.4|80.0|
73827019|NCT04232839|147200503|OTHER||Adjusted geometric mean (gMean) ratio(%)|72.1|||||TWO_SIDED|90.0|67.4|77.1|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||77.1|67.4|
73827020|NCT04232839|147200503|OTHER||Adjusted geometric mean (gMean) ratio(%)|92.2|||||TWO_SIDED|90.0|86.3|98.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||98.6|86.3|
73827021|NCT04232839|147200503|OTHER||Adjusted geometric mean (gMean) ratio(%)|75.5|||||TWO_SIDED|90.0|70.6|80.7|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||80.7|70.6|
73827022|NCT04232839|147200503|OTHER||Adjusted geometric mean (gMean) ratio(%)|134.2|||||TWO_SIDED|90.0|117.6|153.0|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =17.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||153.0|117.6|
73827023|NCT04232839|147200503|OTHER||Adjusted geometric mean (gMean) ratio(%)|114.8|||||TWO_SIDED|90.0|102.9|128.1|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =16.1.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||128.1|102.9|
73827024|NCT03217591|147200505|SUPERIORITY||Geometric mean change (%)|-16.0|||=|0.2142|TWO_SIDED|90.0|-33.3|5.8|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat 20 mg. Geometric mean change (%) and the associated confidence intervals (CIs) were derived as 100×\[exp(Least Squares Mean Change)-1\].||5.8|-33.3|=0.2142
73827025|NCT03217591|147200505|SUPERIORITY||Geometric mean change (%)|-14.6|||=|0.2718|TWO_SIDED|90.0|-32.7|8.3|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat 40 mg. Geometric mean change (%) and the associated CIs were derived as 100×\[exp(Least Squares Mean Change)-1\].||8.3|-32.7|=0.2718
73827026|NCT03217591|147200505|SUPERIORITY||Geometric mean change (%)|-15.3|||=|0.1736|TWO_SIDED|90.0|-30.7|3.6|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat overall. Geometric mean change (%) and the associated CIs were derived as 100×\[exp(Least Squares Mean Change)-1\].||3.6|-30.7|=0.1736
73827027|NCT02357459|147200509|SUPERIORITY|The analysis included all study weeks of data, and was not confined to only that at Baseline and Week 12. Descriptive statistics included number of observations, unadjusted mean, standard deviation, median, minimum and maximum, and baseline adjusted means from the mixed model. Treatment differences from control was presented, and estimated via least squares means from the analysis model along with 95% confidence intervals and associated 2-sided p-values.|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.47|-0.49||The threshold for significance was \<0.05.|longitudinal mixed repeated measures|||||-0.49|-1.47|<0.0001
73827028|NCT01548599|147200523|SUPERIORITY||Odds Ratio, log|2.028||||0.002|TWO_SIDED|95.0|0.766|3.289|||Mixed Models Analysis|||||3.289|0.766|0.002
73827029|NCT01548599|147200524|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73827030|NCT01548599|147200525|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
73827031|NCT01548599|147200526|SUPERIORITY||Odds Ratio (OR)|0.261|STANDARD_ERROR_OF_MEAN|0.398||0.378|TWO_SIDED|95.0|0.013|5.165|||Mixed Models Analysis|||||5.165|0.013|0.378
73827032|NCT01548599|147200527|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73827033|NCT01548599|147200528|SUPERIORITY|||||||0.398|||||||Mixed Models Analysis|||||||0.398
73827034|NCT05630196|147200529|SUPERIORITY||Posterior Mean Difference|0.39|||||TWO_SIDED|95.0|-0.22|1.0|||||Posterior mean difference with 95% credible interval is reported.|||1.00|-0.22|
73827035|NCT05630196|147200530|SUPERIORITY||Posterior Mean Difference|1.16|||||TWO_SIDED|95.0|-0.44|2.77|||||Posterior mean difference with 95% credible interval is reported.|||2.77|-0.44|
73827036|NCT05630196|147200531|SUPERIORITY||Posterior Mean Difference|0.22|||||TWO_SIDED|95.0|-0.23|0.67|||||Posterior mean difference with 95% credible interval is reported.|||0.67|-0.23|
73827037|NCT05630196|147200532|SUPERIORITY||Posterior Mean Difference|0.52|||||TWO_SIDED|95.0|-0.13|1.18|||||Posterior mean difference with 95% credible interval is reported.|||1.18|-0.13|
73827038|NCT05630196|147200533|SUPERIORITY||Posterior Mean Difference|4.2|||||TWO_SIDED|95.0|-3.51|11.87|||||Posterior mean difference with 95% credible interval is reported.|||11.87|-3.51|
73827039|NCT05630196|147200534|SUPERIORITY||Posterior Mean Difference|-0.34|||||TWO_SIDED|95.0|-0.74|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.74|
73827040|NCT05630196|147200535|SUPERIORITY||Posterior Mean Difference|-11.11|||||TWO_SIDED|95.0|-159.85|136.77|||||Posterior mean difference with 95% credible interval is reported.|||136.77|-159.85|
73827041|NCT05630196|147200536|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.11|
73827042|NCT03438266|147200537|NON_INFERIORITY|If the upper limit of the confidence interval at Month 1 was less than 0.5, then treatment with cannula was considered non-inferior to treatment with needle.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.05|0.25|||||The 95% CI is based on the paired t-test.|Change from Baseline at Month 1||0.25|-0.05|
73827043|NCT03438266|147200538|OTHER||Percentage Difference|-1.7|||||TWO_SIDED|95.0|-7.31|3.98||||||||3.98|-7.31|
73896541|NCT03456882|147326408|SUPERIORITY||difference between mean slopes|0.41|STANDARD_ERROR_OF_MEAN|0.16||0.0101|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the on-treatment period (change per week, from baseline to week 24) between treatment groups. Null hypothesis: the rate of change from baseline to week 24 is not different between groups.||||0.0101
73827044|NCT02990000|147200548|SUPERIORITY|We used the Optimal Design program to determine the minimum numbers of therapists and patients needed to detect a moderate effect of condition (standardized difference between change rates = .50). Based on this a priori power analysis, we will need a total of 44 therapists and 211 patients to achieve a power of .80 to detect moderate condition effects. Factoring in a 25% dropout rate, enrolling 281 patients should provide sufficient statistical power.|condition effect on weekly change rate|-0.04|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|-0.05|-0.03|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the TOP-CS average z-scores. Given that higher TOP-CS z-scores indicate greater impairment, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.03|-0.05|.02
73827045|NCT02990000|147200549|SUPERIORITY||condition effect on weekly change rate|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.03|TWO_SIDED|95.0|-0.3|-0.02|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the SCL-10 total score. Given that higher SCL-10 scores indicate greater psychological distress, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.02|-0.30|.03
73827046|NCT02990000|147200550|SUPERIORITY||condition effect on weekly change rate|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.65|TWO_SIDED|95.0|-0.33|0.21|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the patient-rated WAI. Given that higher WAI scores indicate better quality therapeutic alliances, positive slopes indicate a weekly increase in alliance during treatment (i.e., a better outcome or more improvement).||0.21|-0.33|.65
73827047|NCT02990000|147200551|SUPERIORITY||condition effect on weekly change rate|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.41|TWO_SIDED|95.0|-0.17|0.07|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the OE subscale of the CEQ. Given that higher OE scores indicate more optimistic expectations, positive slopes indicate a weekly increase in OE during treatment (i.e., a better outcome or more improvement).||0.07|-0.17|.41
73827048|NCT02990000|147200552|SUPERIORITY||condition effect on weekly change rate|-0.01|STANDARD_ERROR_OF_MEAN|0.002||0.01|TWO_SIDED|95.0|-0.01|-0.006|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the log-transformed TOP-CS domain-specific z-scores. Given that higher z-scores indicate greater impairment, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.006|-0.01|.01
73827049|NCT02990000|147200553|SUPERIORITY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.48||0.48|TWO_SIDED||||||Multilevel logistic regression|||Multilevel logistic regression analysis with patients nested within therapists (Scientific Match = 1; Pragmatic Match = 0). Statistically significant odds ratios that are greater than 1 would indicate that patients in the Scientific Match Condition were more likely to discontinue treatment early, whereas odds ratios that are less than 1 would indicate the opposite.||||.48
73827050|NCT02990000|147200554|SUPERIORITY||condition effect on satisfaction|0.37|STANDARD_ERROR_OF_MEAN|0.48||0.44|TWO_SIDED|95.0|-0.57|1.31|||2-level hierarchical linear model|||Due to the nested nature of the data (patients nested within therapists), we used a two-level hierarchical linear model to test the effect of condition on provider satisfaction at posttreatment. Because higher values indicate more satisfaction, a positive condition effect would indicate that Scientific Match patients were more satisfied than Pragmatic Match patients, whereas a negative condition effect would indicate the opposite.||1.31|-0.57|.44
73827051|NCT02308046|147200555|SUPERIORITY|||||||0.002|||||||Chi-squared, Corrected|||||||0.002
73827052|NCT02308046|147200556|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
73827053|NCT02308046|147200557|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of culture cure at 7-14 days||||<0.001
73827054|NCT02308046|147200557|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of culture cure at 21-30 days||||<0.001
73827055|NCT02308046|147200558|SUPERIORITY|||||||0.088|||||||Chi-squared, Corrected|||Comparison of the number of subjects whose reported their symptoms completely resolved||||0.088
73827056|NCT00526474|147200605|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.001|TWO_SIDED|95.0|0.82|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.82|0.001
73827057|NCT00526474|147200606|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87|||<|0.001|TWO_SIDED|95.0|0.8|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.80|<0.001
73827058|NCT00526474|147200607|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.51|||<|0.001|TWO_SIDED|95.0|1.31|1.74|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.74|1.31|<0.001
73827059|NCT00526474|147200608|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.41|||<|0.001|TWO_SIDED|95.0|1.31|1.51|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.51|1.31|<0.001
73827060|NCT00526474|147200609|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.009|TWO_SIDED|95.0|0.85|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.85|0.009
73827061|NCT00526474|147200610|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.002|TWO_SIDED|95.0|0.78|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.78|0.002
73827062|NCT00526474|147200611|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87|||<|0.001|TWO_SIDED|95.0|0.81|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.81|<0.001
73827063|NCT00526474|147200612|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.001|TWO_SIDED|95.0|0.86|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.96|0.86|0.001
73827064|NCT00526474|147200613|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9|||<|0.001|TWO_SIDED|95.0|0.85|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.85|<0.001
73827065|NCT00526474|147200614|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.151|TWO_SIDED|95.0|0.76|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.04|0.76|0.151
73827066|NCT00526474|147200615|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.001|TWO_SIDED|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.74|0.001
73827067|NCT00526474|147200616|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.108|TWO_SIDED|95.0|0.75|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.75|0.108
73827068|NCT00526474|147200617|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||0.733|TWO_SIDED|95.0|0.83|1.14|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.14|0.83|0.733
73827069|NCT00526474|147200618|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.411|TWO_SIDED|95.0|0.85|1.07|||Cox Proportional Hazards Regression||Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.07|0.85|0.411
73827070|NCT00526474|147200619|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.001|TWO_SIDED|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.74|0.001
73827071|NCT00526474|147200620|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||<|0.001|TWO_SIDED|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.83|<0.001
73827072|NCT00526474|147200621|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.76|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.90|0.76|<0.001
73827073|NCT00526474|147200622|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|||<|0.001|TWO_SIDED|95.0|0.73|0.89|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.89|0.73|<0.001
73827074|NCT00526474|147200623|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.45|||<|0.001|TWO_SIDED|95.0|1.23|1.71|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.71|1.23|<0.001
73827075|NCT00526474|147200624|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.42|||<|0.001|TWO_SIDED|95.0|1.31|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.54|1.31|<0.001
73827076|NCT00526474|147200625|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.79|<0.001
73827077|NCT00526474|147200626|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.75|<0.001
73827078|NCT00526474|147200627|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.77|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.90|0.77|<0.001
73827079|NCT00526474|147200628|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||<|0.001|TWO_SIDED|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.83|<0.001
73827080|NCT00526474|147200629|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88|||<|0.001|TWO_SIDED|95.0|0.83|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.83|<0.001
73827081|NCT00526474|147200630|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.108|TWO_SIDED|95.0|0.71|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.71|0.108
73827082|NCT00526474|147200631|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.82||||0.002|TWO_SIDED|95.0|0.73|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.73|0.002
73827083|NCT00526474|147200632|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.127|TWO_SIDED|95.0|0.74|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.04|0.74|0.127
73827084|NCT00526474|147200633|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.67||||0.002|TWO_SIDED|95.0|0.52|0.87|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.87|0.52|0.002
73827085|NCT00526474|147200634|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.92||||0.249|TWO_SIDED|95.0|0.8|1.06|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.06|0.80|0.249
73827086|NCT00526474|147200635|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.019|TWO_SIDED|95.0|0.76|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.76|0.019
73827087|NCT00526474|147200636|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.003|TWO_SIDED|95.0|0.83|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.96|0.83|0.003
73827088|NCT01587885|147200637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.548|||<|0.048|||||||Regression, Cox|||||||<0.0480
73827089|NCT00975416|147200663|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED||||||ANOVA|||Repeated measures ANOVA to deterimine whether oxytocin increased compared to placebo measures of therapeutic alliance (as measured by the Helping alliance questionnaire) pre compared to post 12 sessions of CBT.||||0.927
73827090|NCT00975416|147200663|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||Repeated measures anova to determine if oxytocin compared to placebo increased therpeutic alliance as measured by the working alliance inventory after 12 sessions of CBT.||||0.60
73827091|NCT01249131|147200679|SUPERIORITY_OR_OTHER||Ratio of Least Squares (LS) Means (in %)|94.7|||||TWO_SIDED|90.0|83.9|107.0|||||LS mean was calculated from analysis of variance (ANOVA). Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||107|83.9|
73827092|NCT01249131|147200679|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|110.0|||||TWO_SIDED|90.0|98.2|124.0|||||LS mean was calculated from ANOVA. Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||124|98.2|
73827093|NCT01249131|147200680|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|96.9|||||TWO_SIDED|90.0|84.2|111.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||111|84.2|
73827094|NCT01249131|147200680|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|107.0|||||TWO_SIDED|90.0|93.8|123.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||123|93.8|
73827095|NCT03555149|147200697|OTHER||Difference in Overall Response Rate|6.67|||||TWO_SIDED|95.0|-11.92|25.25|||||The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib) subtracted from the control arm (Regorafenib).|||25.25|-11.92|
73827096|NCT03555149|147200697|OTHER||Difference in Overall Response Rate|6.67|||||TWO_SIDED|95.0|-11.92|25.25|||||The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib + AB928) subtracted from the control arm (Regorafenib).|||25.25|-11.92|
73827097|NCT03555149|147200698|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.67|2.73||||||||2.73|0.67|
73827098|NCT03555149|147200698|OTHER||Hazard Ratio (HR)|2.3|||||TWO_SIDED|95.0|1.08|4.88||||||||4.88|1.08|
73827099|NCT03555149|147200698|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.29|2.18||||||||2.18|0.29|
73827100|NCT03555149|147200698|OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|95.0|0.64|6.24||||||||6.24|0.64|
73827101|NCT03555149|147200698|OTHER||Hazard Ratio (HR)|1.74|||||TWO_SIDED|95.0|0.83|3.63||||||||3.63|0.83|
73827102|NCT03555149|147200698|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.39|1.63||||||||1.63|0.39|
73827103|NCT03555149|147200698|OTHER||Hazard Ratio (HR)|5.64|||||TWO_SIDED|95.0|0.94|33.82||||||||33.82|0.94|
73827104|NCT03555149|147200699|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.71|2.93||||||Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS||2.93|0.71|
73827105|NCT03555149|147200699|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.68|2.81||||||Atezolizumab + Isatuximab vs. Regorafenib (Control) Hazard Ratio for OS||2.81|0.68|
73827106|NCT03555149|147200699|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.72||||||Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS||2.72|0.30|
73827107|NCT03555149|147200699|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.42|3.84||||||Atezolizumab + Idasanutlin vs. Regorafenib (Control) Hazard Ratio for OS||3.84|0.42|
73827108|NCT03555149|147200699|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.39|1.88||||||Atezolizumab + Regorafenib vs. Regorafenib (Control) Hazard Ratio for OS||1.88|0.39|
73827109|NCT03555149|147200699|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.43|1.96||||||Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) Hazard Ratio for OS||1.96|0.43|
73827110|NCT03555149|147200699|OTHER|Kaplan-Meier|Hazard Ratio (HR)|2.88|||||TWO_SIDED|95.0|0.33|24.85||||||Atezolizumab + LOAd703 vs. Regorafenib (Control) Hazard Ratio for OS||24.85|0.33|
73827111|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||32.19|-0.61|
73827112|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|-16.49|||||TWO_SIDED|95.0|-49.78|16.79||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||16.79|-49.78|
73827113|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|-14.45|||||TWO_SIDED|95.0|-44.37|15.47||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||15.47|-44.37|
73827114|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|-10.56|||||TWO_SIDED|95.0|-32.25|11.14||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||11.14|-32.25|
73827115|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|-10.88|||||TWO_SIDED|95.0|-38.62|16.87||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||16.87|-38.62|
73827116|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|-23.16|||||TWO_SIDED|95.0|-56.1|9.78||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||9.78|-56.10|
73827117|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|-7.78|||||TWO_SIDED|95.0|-39.19|23.62||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||23.62|-39.19|
73827118|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|2.78|||||TWO_SIDED|95.0|-24.08|29.63||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||29.63|-24.08|
73827119|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||32.19|-0.61|
73827120|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|16.84|||||TWO_SIDED|95.0|-24.39|58.07||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||58.07|-24.39|
73827121|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|18.88|||||TWO_SIDED|95.0|-34.53|72.3||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||72.30|-34.53|
73827122|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|9.44|||||TWO_SIDED|95.0|-38.19|57.08||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||57.08|-38.19|
73827123|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|-9.21|||||TWO_SIDED|95.0|-54.7|36.28||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||36.28|-54.70|
73827124|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|-13.16|||||TWO_SIDED|95.0|-66.74|40.43||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||40.43|-66.74|
73827125|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|-9.45|||||TWO_SIDED|95.0|-57.26|38.36||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||38.36|-57.26|
73827126|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|7.78|||||TWO_SIDED|95.0|-38.18|53.73||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||53.73|-38.18|
73827127|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|-5.24|||||TWO_SIDED|95.0|-32.03|21.56||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||21.56|-32.03|
73827128|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|8.64|||||TWO_SIDED|95.0|-23.33|40.6||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||40.60|-23.33|
73827129|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|5.44|||||TWO_SIDED|95.0|-29.19|40.06||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||40.06|-29.19|
73827130|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|6.71|||||TWO_SIDED|95.0|-22.64|36.06||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||36.06|-22.64|
73827131|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|2.46|||||TWO_SIDED|95.0|-21.31|26.22||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||26.22|-21.31|
73827132|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|10.18|||||TWO_SIDED|95.0|-20.99|41.34||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||41.34|-20.99|
73827133|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|-1.12|||||TWO_SIDED|95.0|-33.59|31.36||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||31.36|-33.59|
73827134|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|9.44|||||TWO_SIDED|95.0|-19.06|37.94||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||37.94|-19.06|
73827135|NCT03555149|147200700|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab +LOAd703 vs. Regorafenib (Control) arms||32.19|-0.61|
73827136|NCT02965924|147200704|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
73827137|NCT01474486|147200714|OTHER|||||||0.64|||||||Mixed Models Analysis|||||||0.64
73827138|NCT03292016|147200768|OTHER||Geometric Mean ratio (APL-130277/APOKYN)|12.3|||||TWO_SIDED|90.0|7.5|20.3|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||Sample size of 12 subjects, a two-sided 90% CI for the difference in paired PK parameter means on the log scale will have an interval that extends no more than 0.221 units from the observed difference with 90% coverage probability. Assumes CV of 35% for the difference on the original scale.||20.3|7.5|
73827139|NCT03292016|147200768|OTHER||Geometric Mean ratio (APL-130277/APO-go)|10.3|||||TWO_SIDED|90.0|6.5|16.3||||||||16.3|6.5|
73827140|NCT03292016|147200768|OTHER|relative bioavailibilty|Geometric Mean ratio (APOKYN/APO-go)|83.4|||||TWO_SIDED|90.0|50.5|137.6||||||||137.6|50.5|
73827141|NCT03292016|147200768|OTHER||Ratio|0.21|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg|||||
73827142|NCT03292016|147200768|OTHER||Ratio|0.13|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg|||||
73827143|NCT03292016|147200768|OTHER||Ratio|1.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg|||||
73827144|NCT03292016|147200768|OTHER||Ratio|0.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg|||||
73827145|NCT03292016|147200768|OTHER||Ratio|0.17|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg|||||
73827146|NCT03292016|147200768|OTHER||Ratio|1.12|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg|||||
73827147|NCT03292016|147200768|OTHER||Ratio|0.08|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg|||||
73827148|NCT03292016|147200768|OTHER||Ratio|0.09|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg|||||
73827149|NCT03292016|147200768|OTHER||Ratio|1.04|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg|||||
73827150|NCT03292016|147200769|OTHER|||||||0.0625|||||||Sign test|||||||0.0625
73827151|NCT03292016|147200769|OTHER|||||||0.0313|||||||Sign test|||||||0.0313
73827152|NCT03292016|147200769|OTHER||||||>|0.9999|||||||Sign test|||||||>0.9999
73827153|NCT03292016|147200770|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|17.2|||||TWO_SIDED|90.0|13.1|22.5|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||||22.5|13.1|
73827154|NCT03292016|147200770|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|16.7|||||TWO_SIDED|90.0|13.0|21.3|||Mixed Models Analysis|||||21.3|13.0|
73827155|NCT03292016|147200770|OTHER||Geometric Mean Ratio (APOKYN/APO-go)|96.9|||||TWO_SIDED|90.0|74.2|126.4||||||||126.4|74.2|
73827156|NCT03292016|147200770|OTHER||Ratio|0.32|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg|||||
73827157|NCT03292016|147200770|OTHER||Ratio|0.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg|||||
73827158|NCT03292016|147200770|OTHER||Ratio|1.09|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg|||||
73827159|NCT03292016|147200770|OTHER||Ratio|0.23|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg|||||
73827160|NCT03292016|147200770|OTHER||Ratio|0.23|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg|||||
73827161|NCT03292016|147200770|OTHER||Ratio|1.0|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg|||||
73827162|NCT03292016|147200770|OTHER||Ratio|0.15|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg|||||
73827163|NCT03292016|147200770|OTHER||Ratio|0.14|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg|||||
73827164|NCT03292016|147200770|OTHER||Ratio|0.96|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg|||||
73827165|NCT03292016|147200771|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|17.6|||||TWO_SIDED|90.0|13.7|22.5|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||||22.5|13.7|
73827166|NCT03292016|147200771|OTHER||Geometric Mean Ratio (APL-130277/APO-go)|17.2|||||TWO_SIDED|90.0|13.7|21.6|||Mixed Models Analysis|||||21.6|13.7|
73827167|NCT03292016|147200771|OTHER||Geometric Mean Ratio (APOKYN/APO-go)|97.8|||||TWO_SIDED|90.0|76.6|124.8|||Mixed Models Analysis|||||124.8|76.6|
73827168|NCT03292016|147200776|OTHER|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
73827169|NCT03292016|147200776|OTHER|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
73827170|NCT03292016|147200776|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||||||>0.9999
73827171|NCT01038687|147200799|SUPERIORITY|||||||0.059|||||||ANCOVA|||||||0.059
73827172|NCT01038687|147200799|SUPERIORITY|||||||0.18|||||||Dunnett's test|||15mg dose vs placebo||||0.18
73827173|NCT01038687|147200799|SUPERIORITY|||||||0.04|||||||Dunnett's test|||20mg dose vs placebo||||0.04
73827174|NCT01038687|147200800|SUPERIORITY|||||||0.81|||||||ANCOVA|||||||0.81
73827175|NCT01038687|147200800|SUPERIORITY|||||||0.89|||||||Dunnett's test|||15mg dose vs placebo||||0.89
73827176|NCT01038687|147200800|SUPERIORITY|||||||0.76|||||||Dunnett's test|||20mg dose vs placebo||||0.76
73827177|NCT01038687|147200801|SUPERIORITY|||||||0.075|||||||ANCOVA|||||||0.075
73827178|NCT01038687|147200801|SUPERIORITY|||||||0.058|||||||Dunnett's test|||15mg dose vs placebo||||0.058
73827179|NCT01038687|147200801|SUPERIORITY|||||||0.164|||||||Dunnett's test|||20mg dose vs placebo||||0.164
73827180|NCT01038687|147200802|SUPERIORITY|||||||0.084|||||||ANCOVA|||||||0.084
73827181|NCT01038687|147200802|SUPERIORITY|||||||0.98|||||||Dunnett's test|||15mg vs placebo||||0.98
73827182|NCT01038687|147200802|SUPERIORITY|||||||0.079|||||||Dunnett's test|||20mg vs placebo||||0.079
73827183|NCT01038687|147200803|SUPERIORITY|||||||0.058|||||||ANCOVA|||||||0.058
73827184|NCT01038687|147200803|SUPERIORITY|||||||0.32|||||||Dunnett's test|||15mg dose vs placebo||||0.32
73827185|NCT01038687|147200803|SUPERIORITY|||||||0.034|||||||Dunnett's test|||20mg dose vs placebo||||0.034
73827186|NCT01038687|147200804|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
73827187|NCT01038687|147200804|SUPERIORITY|||||||0.002|||||||Dunnett's test|||15mg dose vs placebo||||0.002
73827188|NCT01038687|147200804|SUPERIORITY|||||||0.001|||||||Dunnett's test|||20mg vs placebo||||0.001
73827189|NCT01038687|147200805|SUPERIORITY|||||||0.091|||||||ANCOVA|||||||0.091
73827190|NCT01038687|147200805|SUPERIORITY|||||||0.99|||||||Dunnett's test|||15mg dose vs placebo||||0.99
73827191|NCT01038687|147200805|SUPERIORITY|||||||0.103|||||||Dunnett's test|||20mg vs placebo||||0.103
73827192|NCT01038687|147200806|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
73827193|NCT01038687|147200806|SUPERIORITY|||||||0.002|||||||Dunnett's test|||15mg dose vs placebo||||0.002
73827194|NCT01038687|147200806|SUPERIORITY|||||||0.001|||||||Dunnett's test|||20mg dose vs placebo||||0.001
73827195|NCT01038687|147200807|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
73827196|NCT01038687|147200807|SUPERIORITY|||||||0.053|||||||Dunnett's test|||15mg dose vs placebo||||0.053
73827197|NCT01038687|147200807|SUPERIORITY|||||||0.002|||||||Dunnett's test|||20mg dose vs placebo||||0.002
73827198|NCT02368132|147200846|SUPERIORITY||Least squares mean difference|-8.73|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Estimated difference in least square means between Usual Care (reference) and Group Delivered TEP arm at 3 months.|||||<0.001
73827199|NCT02368132|147200846|SUPERIORITY||Least squares mean difference|-5.15|STANDARD_ERROR_OF_MEAN|2.42||0.04|TWO_SIDED||||||Mixed Models Analysis||Estimated difference in least square means between Usual Care (reference) and Individual Delivered TEP arm at 3 months.|||||0.04
73827200|NCT02314728|147200849|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
73827201|NCT02314728|147200850|SUPERIORITY|||||||0.6|||||||Fisher Exact|||NICU admission||||0.60
73827202|NCT02314728|147200850|SUPERIORITY|||||||0.13|||||||Fisher Exact|||histologic chorioamnionitis||||0.13
73827203|NCT03118934|147200864|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.5. With a sample size of 80/group, there was approximately 83% power to reject the null hypothesis of inferiority in fit with assumed standard deviation of 0.6 and expected difference of 0.25 (one-sided alpha=0.05).|LSM Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|||ONE_SIDED|95.0||-0.1||||||||-0.1||
73827204|NCT01614470|147200865|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|10.678|||<|0.0001|TWO_SIDED|95.0|7.2559|14.1|||Mixed Models Analysis|||||14.1000|7.2559|<0.0001
73827205|NCT01614470|147200866|SUPERIORITY_OR_OTHER||LS mean difference|0.6624|||<|0.0001|TWO_SIDED|95.0|0.3366|0.9881|||Mixed Models Analysis|||||0.9881|0.3366|<0.0001
73827206|NCT01614470|147200868|SUPERIORITY_OR_OTHER||LS mean difference|-49.1667|||<|0.0001|TWO_SIDED|95.0|-56.9527|-41.3807|||Mixed Models Analysis|||||-41.3807|-56.9527|<0.0001
73827207|NCT01614470|147200871|SUPERIORITY_OR_OTHER||LS mean difference|9.6105||||0.0004|TWO_SIDED|95.0|4.4874|14.7336|||Mixed Models Analysis|||||14.7336|4.4874|0.0004
73827208|NCT02848664|147200942|OTHER|Same DOSS score before and after device use for 3 months or improved DOSS score after device use for 3 months|||||<|0.025||||||p values adjusted for multiple comparisons (two outcome measures)|Wilcoxon (Mann-Whitney)|||Examined change in DOSS for each participant from before to after three months of device use. Examined numbers of participants who showed either worsening of DOSS, no improvement in DOSS or improvement of DOSS.||||<0.025
73827209|NCT02848664|147200943|EQUIVALENCE|Examination of whether the level of swallowing handicap is changed following device use|Mean Difference (Net)|22.571||||0.016|TWO_SIDED|95.0|6.003|39.14|||t-test, 2 sided|||||39.140|6.003|0.016
73827210|NCT02848664|147200944|EQUIVALENCE|whether the degree of laryngeal elevation relative to hyoid elevation became greater or less after device use for 3 months||||||0.046|||||||t-test, 2 sided|||||||0.046
73827211|NCT02848664|147200945|EQUIVALENCE|pairwise comparison within subject comparing baseline with 3 months post device use|Mean Difference (Final Values)|-52.78||||0.037|TWO_SIDED|95.0|-100.751|-4.809|||ANOVA|||||-4.809|-100.751|0.037
73827212|NCT00492726|147200987|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set to 10% in the protocol, in agreement with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population.|Difference of cure rates (in percent)|-3.8||||||95.0|-7.9|0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||0.4|-7.9|
73827213|NCT00492726|147200988|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in improvement rates (in %)|1.1||||||95.0|-0.4|2.7|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||2.7|-0.4|
73827214|NCT00492726|147200989|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.0|-8.8|
73827215|NCT00492726|147200990|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-1.5||||||95.0|-5.0|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.9|-5.0|
73827216|NCT00492726|147200991|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.0|-8.8|
73827217|NCT00492726|147200992|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.8||||||95.0|-9.0|1.5|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without super- or reinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.5|-9.0|
73827218|NCT00492726|147200993|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-2.9||||||95.0|-7.6|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.9|-7.6|
73827219|NCT01181167|147201016|NON_INFERIORITY_OR_EQUIVALENCE|"Difference in incidence of thromboembolic events between DU-176b and enoxaparin groups and 95% confidence interval (CI) were calculated.~Incidence of thromboembolic events and 95% CI also calculated by treatment group.~Only when null hypothesis H01 was rejected, upper limit of 95% CI for difference between DU-176b and enoxaparin groups was confirmed. When upper limit of 95% CI was below 0%, DU-176b was considered to be superior to enoxaparin in terms of the prevention of VTE."|Cox Proportional Hazard|-4.5|||<|0.001|ONE_SIDED|95.0||||Farrington Manning Method|ANCOVA|||Hypothesis testing of proportion of subjects who experienced at least one thromboembolic events, defined as primary endpoint, carried out using Farrington-Manning method. Null hypothesis H˅01: Incidence of thromboembolic events in DU-176b group (P˅DU) = Incidence of thromboembolic events in enoxaparin group (P˅E) + Δ (8%). Alternative hypothesis H˅11: P˅DU \< P˅E + Δ (significance level: One-sided, 0.025)||||<0.001
73827220|NCT02683109|147201030|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the Tio+Olo FDC versus the Tio/Olo free combination was tested at the one-sided α-level of 0.025 using a non-inferiority margin of 0.1 L.|Adjusted mean|0.024|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|-0.02|0.067|||ANCOVA|||The primary analysis was conducted using an Analysis of Covariance \[ANCOVA\] model including treatment as fixed categorical effect and baseline as continuous covariate.||0.067|-0.020|<0.0001
73827221|NCT02683109|147201031|SUPERIORITY_OR_OTHER||Adjusted mean|0.006|STANDARD_ERROR_OF_MEAN|0.034||0.8648|TWO_SIDED|95.0|-0.061|0.073|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.||0.073|-0.061|0.8648
73827222|NCT02683109|147201032|SUPERIORITY_OR_OTHER||Adjusted mean|-0.327|STANDARD_ERROR_OF_MEAN|0.536||0.542|TWO_SIDED|95.0|-1.384|0.729|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.||0.729|-1.384|0.5420
73827223|NCT01178294|147201042|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||one-sided binomial exact test|||Summary statistics for the percentage of participants with serious bleeding episodes responsive at 24 hours after the initiation of treatment are presented, along with the 95% confidence interval (two-sided 95% Clopper-Pearson confidence interval).||||<0.001
73827224|NCT02089347|147201060|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|1.42|||||TWO_SIDED|95.0|-0.31|4.61||||||Non-inferiority comparison of post-booster response for Diphtheria.||4.61|-0.31|
73827225|NCT02089347|147201060|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by the data if lower bound ot the two-sided 95% is greater than -10%|Wilson score method|6.25|||||TWO_SIDED|95.0|3.32|10.84||||||Non-inferiority comparison of post-vaccination booster response for tetanus||10.84|3.32|
73827226|NCT02089347|147201061|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|0.57|||||TWO_SIDED|95.0|-0.61|3.15||||||Non-inferiority comparison of Diphtheria post-vaccination seroprotection rates at ≥ 0.1 IU/mL||3.15|-0.61|
73827227|NCT02089347|147201061|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%.|Wilson score method|0.0|||||TWO_SIDED|95.0|-1.09|2.14||||||Non-inferiority comparison of Tetanus post-vaccination seroprotection rates at ≥ 0.1 IU/mL||2.14|-1.09|
73827228|NCT02662569|147201098|SUPERIORITY||LS Mean Treatment Difference|-70.29|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-75.43|-65.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-65.16|-75.43|<0.0001
73827229|NCT02662569|147201098|SUPERIORITY||LS Mean Treatment Difference|-70.04|STANDARD_ERROR_OF_MEAN|2.35|<|0.0001|TWO_SIDED|95.0|-74.67|-65.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-65.41|-74.67|<0.0001
73827230|NCT02662569|147201099|SUPERIORITY||LS Mean Treatment Difference|-71.77|STANDARD_ERROR_OF_MEAN|2.97|<|0.0001|TWO_SIDED|95.0|-77.61|-65.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-65.93|-77.61|<0.0001
73827231|NCT02662569|147201099|SUPERIORITY||LS Mean Treatment Difference|-64.93|STANDARD_ERROR_OF_MEAN|2.56|<|0.0001|TWO_SIDED|95.0|-69.97|-59.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-59.89|-69.97|<0.0001
73827232|NCT02662569|147201100|SUPERIORITY||LS Mean Treatment Difference|-62.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-68.2|-56.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.9|-68.2|<0.0001
73827233|NCT02662569|147201100|SUPERIORITY||LS Mean Treatment Difference|-63.1|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-68.4|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-57.8|-68.4|<0.0001
73827234|NCT02662569|147201101|SUPERIORITY||LS Mean Treatment Difference|-63.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-69.7|-57.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-57.6|-69.7|<0.0001
73827235|NCT02662569|147201101|SUPERIORITY||LS Mean Treatment Difference|-58.8|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-64.3|-53.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-53.3|-64.3|<0.0001
73827236|NCT02662569|147201102|SUPERIORITY||LS Mean Treatment Difference|-60.9|STANDARD_ERROR_OF_MEAN|2.35|<|0.0001|TWO_SIDED|95.0|-65.51|-56.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.29|-65.51|<0.0001
73827237|NCT02662569|147201102|SUPERIORITY||LS Mean Treatment Difference|-59.4|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-63.52|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-55.29|-63.52|<0.0001
73827238|NCT02662569|147201103|SUPERIORITY||LS Mean Treatment Difference|-61.64|STANDARD_ERROR_OF_MEAN|2.64|<|0.0001|TWO_SIDED|95.0|-66.82|-56.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.45|-66.82|<0.0001
73827239|NCT02662569|147201103|SUPERIORITY||LS Mean Treatment Difference|-54.22|STANDARD_ERROR_OF_MEAN|2.28|<|0.0001|TWO_SIDED|95.0|-58.7|-49.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-49.74|-58.70|<0.0001
73827240|NCT02662569|147201104|SUPERIORITY||LS Mean Treatment Difference|-56.93|STANDARD_ERROR_OF_MEAN|2.03|<|0.0001|TWO_SIDED|95.0|-60.93|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-52.93|-60.93|<0.0001
73827241|NCT02662569|147201104|SUPERIORITY||LS Mean Treatment Difference|-54.85|STANDARD_ERROR_OF_MEAN|1.87|<|0.0001|TWO_SIDED|95.0|-58.52|-51.18||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-51.18|-58.52|<0.0001
73827242|NCT02662569|147201105|SUPERIORITY||LS Mean Treatment Difference|-57.06|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-61.59|-52.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-52.54|-61.59|<0.0001
73827243|NCT02662569|147201105|SUPERIORITY||LS Mean Treatment Difference|-49.42|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-53.31|-45.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-45.53|-53.31|<0.0001
73827244|NCT02662569|147201106|SUPERIORITY||LS Mean Treatment Difference|-41.53|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-44.95|-38.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-38.10|-44.95|<0.0001
73827245|NCT02662569|147201106|SUPERIORITY||LS Mean Treatment Difference|-39.5|STANDARD_ERROR_OF_MEAN|1.51|<|0.0001|TWO_SIDED|95.0|-42.47|-36.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-36.53|-42.47|<0.0001
73827246|NCT02662569|147201107|SUPERIORITY||LS Mean Treatment Difference|-42.22|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-46.02|-38.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-38.42|-46.02|<0.0001
73827247|NCT02662569|147201107|SUPERIORITY||LS Mean Treatment Difference|-35.89|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED|95.0|-39.12|-32.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-32.67|-39.12|<0.0001
73827248|NCT02662569|147201108|SUPERIORITY||LS Mean Treatment Difference|-44.09|STANDARD_ERROR_OF_MEAN|1.81|<|0.0001|TWO_SIDED|95.0|-47.64|-40.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-40.54|-47.64|<0.0001
73827249|NCT02662569|147201108|SUPERIORITY||LS Mean Treatment Difference|-43.67|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED|95.0|-46.9|-40.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-40.44|-46.90|<0.0001
73827250|NCT02662569|147201109|SUPERIORITY||LS Mean Treatment Difference|-43.94|STANDARD_ERROR_OF_MEAN|2.02|<|0.0001|TWO_SIDED|95.0|-47.9|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-39.97|-47.90|<0.0001
73827251|NCT02662569|147201109|SUPERIORITY||LS Mean Treatment Difference|-40.56|STANDARD_ERROR_OF_MEAN|1.79|<|0.0001|TWO_SIDED|95.0|-44.08|-37.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-37.04|-44.08|<0.0001
73827252|NCT02662569|147201110|SUPERIORITY||LS Mean Treatment Difference|-58.2|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-62.15|-54.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-54.25|-62.15|<0.0001
73827253|NCT02662569|147201110|SUPERIORITY||LS Mean Treatment Difference|-56.73|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-60.53|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-52.93|-60.53|<0.0001
73827254|NCT02662569|147201111|SUPERIORITY||LS Mean Treatment Difference|-58.21|STANDARD_ERROR_OF_MEAN|2.23|<|0.0001|TWO_SIDED|95.0|-62.59|-53.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-53.84|-62.59|<0.0001
73827255|NCT02662569|147201111|SUPERIORITY||LS Mean Treatment Difference|-51.7|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-55.81|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-47.59|-55.81|<0.0001
73827256|NCT02662569|147201112|SUPERIORITY||Treatment Difference|68.4|||<|0.0001|TWO_SIDED|95.0|60.4|74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||74.8|60.4|<0.0001
73827257|NCT02662569|147201112|SUPERIORITY||Treatment Difference|71.9|||<|0.0001|TWO_SIDED|95.0|64.1|77.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM|||77.9|64.1|<0.0001
73827258|NCT02662569|147201113|SUPERIORITY||Treatment Difference|67.2|||<|0.0001|TWO_SIDED|95.0|58.9|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||73.9|58.9|<0.0001
73827259|NCT02662569|147201113|SUPERIORITY||Treatment Difference|68.8|||<|0.0001|TWO_SIDED|95.0|60.6|75.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM|||75.3|60.6|<0.0001
73827260|NCT02662569|147201114|SUPERIORITY||LS Mean Treatment Difference|-55.52|STANDARD_ERROR_OF_MEAN|18.85|<|0.0001|TWO_SIDED|95.0|-92.64|-18.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-18.40|-92.64|<0.0001
73827261|NCT02662569|147201114|SUPERIORITY||LS Mean Treatment Difference|-50.77|STANDARD_ERROR_OF_MEAN|6.63|<|0.0001|TWO_SIDED|95.0|-63.82|-37.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-37.72|-63.82|<0.0001
73827262|NCT02662569|147201115|SUPERIORITY||LS Mean Treatment Difference|-62.46|STANDARD_ERROR_OF_MEAN|24.64|<|0.0001|TWO_SIDED|95.0|-110.89|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-14.03|-110.89|<0.0001
73827263|NCT02662569|147201115|SUPERIORITY||LS Mean Treatment Difference|-45.32|STANDARD_ERROR_OF_MEAN|8.42|<|0.0001|TWO_SIDED|95.0|-61.87|-28.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-28.77|-61.87|<0.0001
73827264|NCT02662569|147201116|SUPERIORITY||LS Mean Treatment Difference|-18.02|STANDARD_ERROR_OF_MEAN|4.01||0.0002|TWO_SIDED|95.0|-25.89|-10.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-10.14|-25.89|0.0002
73827265|NCT02662569|147201116|SUPERIORITY||LS Mean Treatment Difference|-15.63|STANDARD_ERROR_OF_MEAN|3.08|<|0.0001|TWO_SIDED|95.0|-21.69|-9.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-9.58|-21.69|<0.0001
73827266|NCT02662569|147201117|SUPERIORITY||LS Mean Treatment Difference|-16.41|STANDARD_ERROR_OF_MEAN|14.18||0.0002|TWO_SIDED|95.0|-24.63|-8.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-8.19|-24.63|0.0002
73827267|NCT02662569|147201117|SUPERIORITY||LS Mean Treatment Difference|-12.31|STANDARD_ERROR_OF_MEAN|3.28|<|0.0001|TWO_SIDED|95.0|-18.76|-5.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-5.86|-18.76|<0.0001
73827268|NCT02662569|147201118|SUPERIORITY||LS Mean Treatment Difference|6.34|STANDARD_ERROR_OF_MEAN|1.52||0.0003|TWO_SIDED|95.0|3.36|9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||9.33|3.36|0.0003
73827269|NCT02662569|147201118|SUPERIORITY||LS Mean Treatment Difference|7.87|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|5.1|10.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||10.65|5.10|<0.0001
73827270|NCT02662569|147201119|SUPERIORITY||LS Mean Treatment Difference|5.88|STANDARD_ERROR_OF_MEAN|1.72||0.0003|TWO_SIDED|95.0|2.49|9.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||9.27|2.49|0.0003
73827271|NCT02662569|147201119|SUPERIORITY||LS Mean Treatment Difference|8.14|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|5.03|11.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||11.25|5.03|<0.0001
73827272|NCT02662569|147201120|SUPERIORITY||LS Mean Treatment Difference|-27.18|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-34.2|-20.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-20.17|-34.20|<0.0001
73827273|NCT02662569|147201120|SUPERIORITY||LS Mean Treatment Difference|-24.01|STANDARD_ERROR_OF_MEAN|2.99|<|0.0001|TWO_SIDED|95.0|-29.88|-18.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-18.14|-29.88|<0.0001
73827274|NCT03863353|147201129|SUPERIORITY||Rebression coefficient|2.13||||0.001|TWO_SIDED|95.0|0.86|3.4||Adjusted for repeated measures and effects of covariates|Regression, Linear|||Hypothesis was tested using multivariable regression models (generalized estimating equation)||3.40|0.86|.001
73827275|NCT03863353|147201130|SUPERIORITY||Odds Ratio (OR)|1.17||||0.534|TWO_SIDED|95.0|0.72|1.9||adjusted for covariates|Regression, Logistic|||Logistic regression model examined the effect of the intervention on the outcome (collapsed intentions/behaviors)||1.90|0.72|0.534
73827276|NCT02747927|147201135|OTHER||Vaccine Efficacy (VE)|80.2|||<|0.001|TWO_SIDED|95.0|73.3|85.3||Statistical significance was concluded if the lower bound of the 95% CI for the VE was above 25%. Since the hypotheses was tested in a confirmatory manner at a 2-sided significance level of 5%, the calculated p-value was compared with 0.025.|Cox Proportional Hazard Model|VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.||Assuming true VE of 60% and, virologically confirmed cases of dengue fever induced by any dengue serotype occurring from 30 days post 2nd vaccination (Day 120) until end of Part 1 would provide at least 90% power to rule out vaccine effect of ≤25%.||85.3|73.3|<0.001
73827277|NCT00323063|147201159|OTHER|||||||0.3|||||||Log Rank|||||||0.3
73827278|NCT04249427|147201217|EQUIVALENCE|Test if the change in mean number of days with significant mid-facial pain in Erenuman group differs from that in Placebo group.||||||0.96|||||||ANOVA|||||||0.96
73827279|NCT04249427|147201218|EQUIVALENCE|Test if the change in SNOT-22 score in Erenuman group differs from that in Placebo group.||||||0.19|||||||ANOVA|||||||0.19
73827280|NCT04249427|147201219|EQUIVALENCE|Test if the change in Physical Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.06|||||||ANOVA|||||||0.06
73827281|NCT04249427|147201220|EQUIVALENCE|Test if the change in Usual Activities as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
73827282|NCT04249427|147201221|EQUIVALENCE|Test if the change in Social Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.058|||||||ANOVA|||||||0.058
73827283|NCT04249427|147201222|EQUIVALENCE|Test if the change in Emotional Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.02|||||||ANOVA|||||||0.02
73827284|NCT04249427|147201223|EQUIVALENCE|Test if the change in Overall Impact (global) as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.0036|||||||ANOVA|||||||0.0036
73827285|NCT04249427|147201224|EQUIVALENCE|Test if the change of average number of days per month with significant nasal congestion in Erenuman group differs from that in Placebo group.||||||0.83|||||||ANOVA|||||||0.83
73827286|NCT04249427|147201225|EQUIVALENCE|Test if the change of average number of days per month with significant significant rhinorrhea in Erenuman group differs from that in Placebo group||||||0.83|||||||ANOVA|||||||0.83
73827287|NCT04249427|147201226|EQUIVALENCE|Test if the change in doses of rescue pain medications in Erenuman group differs from that in Placebo group.||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
73827288|NCT04249427|147201227|EQUIVALENCE|Test if the change from baseline in mean daily pain score in Erenuman group differs from that in Placebo group.||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
73827289|NCT01419314|147201278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.19|STANDARD_DEVIATION|20.25||0.001|TWO_SIDED|95.0|38.33|52.05|||ANOVA|Sphericity was not tenable for the factor pain scores, degrees of freedom were corrected using Huynh-Feldt estimates, df (1.71,56.46).||A repeated measure ANOVA was performed to evaluate the contrasts of interest.||52.05|38.33|0.001
73827290|NCT01419314|147201278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.09|STANDARD_ERROR_OF_MEAN|3.6|<|0.0005|TWO_SIDED|95.0|8.8|23.39||Bonferroni adjustment for significance\<0.013.|t-test, 2 sided||Paired t-test contrasting pain scores from baseline to week six of the trial-Splint group. The statistical power for the within splint intervention contrast was calculated to be 0.99.|Null hypothesis: Is there a difference in baseline pain scores compared to those at week 6 in the splinting group?||23.39|8.80|<0.0005
73827291|NCT01419314|147201278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|5.27||0.155|TWO_SIDED|95.0|-13.93|7.47||Bonferroni adjustment for significance\<0.013.|t-test, 2 sided|df(35)|The statistical power for the between intervention contrast was calculated to be 0.26|Null Hypothesis: There is not difference in pain scores between the liner and splint applications at week three.||7.47|-13.93|0.155
73827292|NCT01419314|147201278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.67|STANDARD_ERROR_OF_MEAN|6.66||0.155|TWO_SIDED|95.0|-23.2|3.85|||t-test, 2 sided|df(35)||Null Hypothesis: There is no difference in pain scores between the liner and splint applications at week six.||3.85|-23.20|0.155
73827293|NCT00402727|147201287|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set to 10% in the protocol, in agreeance with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population|Difference of cure rates (in percent)|-1.0||||||95.0|-5.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||3.9|-5.3|
73827294|NCT00402727|147201288|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|1.3||||||95.0|-3.8|6.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||6.3|-3.8|
73827295|NCT00402727|147201289|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|-0.7||||||95.0|-1.6|0.6|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||0.6|-1.6|
73827296|NCT00402727|147201290|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|1.4||||||95.0|-1.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||3.9|-1.3|
73827297|NCT00402727|147201291|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|0.2||||||95.0|-3.1|2.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||2.4|-3.1|
73827298|NCT00402727|147201292|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|1.6||||||95.0|-2.4|5.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||5.3|-2.4|
73827299|NCT00402727|147201293|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.5||||||95.0|-17.0|-1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-1.4|-17.0|
73827300|NCT00402727|147201294|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.6||||||95.0|-17.6|-0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-0.4|-17.6|
73827301|NCT00402727|147201295|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-3.9||||||95.0|-9.5|1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||1.4|-9.5|
73827302|NCT00402727|147201296|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-5.6||||||95.0|-11.4|-0.8|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-0.8|-11.4|
73827303|NCT00402727|147201297|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-0.1||||||95.0|-6.9|5.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||5.4|-6.9|
73827304|NCT00402727|147201298|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-2.9||||||95.0|-9.3|2.2|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||2.2|-9.3|
73827305|NCT03188055|147201306|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
73827306|NCT03188055|147201307|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||||||0.709
73827307|NCT03188055|147201308|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
73827308|NCT03188055|147201309|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||0.063
73827309|NCT03188055|147201310|SUPERIORITY|||||||0.892|||||||t-test, 2 sided|||||||0.892
73827310|NCT03188055|147201311|SUPERIORITY||||||>|0.99||||||Using an a priori statistical significance of 0.05.|Fisher Exact|||Comparison of concordance status by intervention status (outcome by predictor).||||> . 99
73827311|NCT03188055|147201312|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||||||0.188
73827312|NCT03188055|147201313|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
73827313|NCT03188055|147201315|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||||||0.698
73827314|NCT03188055|147201316|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
73827315|NCT02084511|147201317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.39|||||TWO_SIDED|95.0|-76.3|131.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||131.1|-76.3|
73827316|NCT02084511|147201317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.48|||||TWO_SIDED|95.0|-50.2|157.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||157.1|-50.2|
73827317|NCT02084511|147201317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-174.61|||||TWO_SIDED|95.0|-278.3|-70.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-70.9|-278.3|
73827318|NCT02084511|147201317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-148.53|||||TWO_SIDED|95.0|-252.4|-44.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-44.7|-252.4|
73827319|NCT02084511|147201318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-2.3|5.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||5.7|-2.3|
73827320|NCT02084511|147201318|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.98|||||TWO_SIDED|95.0|-3.0|5.0|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||5.0|-3.0|
73827321|NCT02084511|147201318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27|||||TWO_SIDED|95.0|-10.3|-2.2|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-2.2|-10.3|
73827322|NCT02084511|147201318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.98|||||TWO_SIDED|95.0|-11.0|-2.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-2.9|-11.0|
73827323|NCT02084511|147201319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.93|||||TWO_SIDED|95.0|-16.0|27.8|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||27.8|-16.0|
73827324|NCT02084511|147201319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.58|||||TWO_SIDED|95.0|-1.3|42.5|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||42.5|-1.3|
73827325|NCT02084511|147201319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.29|||||TWO_SIDED|95.0|-35.2|8.6|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||8.6|-35.2|
73827326|NCT02084511|147201319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.37|||||TWO_SIDED|95.0|-20.6|23.3|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||23.3|-20.6|
73827327|NCT02084511|147201320|SUPERIORITY_OR_OTHER|||||||0.2503|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.2503
73827328|NCT02084511|147201320|SUPERIORITY_OR_OTHER|||||||0.1851|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.1851
73827329|NCT02084511|147201320|SUPERIORITY_OR_OTHER|||||||0.0167|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.0167
73827330|NCT02084511|147201321|SUPERIORITY_OR_OTHER|||||||0.415|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.4150
73827331|NCT02084511|147201321|SUPERIORITY_OR_OTHER|||||||0.3093|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.3093
73827332|NCT02084511|147201321|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.0074
73827333|NCT01328964|147201323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.51|0.974||The p-value is a comparison of the combined hospitalization/emergency department visit endpoint|Regression, Cox|||||0.974|0.51|<0.0001
73827334|NCT01328964|147201324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-19.0|-9.0||P-value is based on the differences in the total monthly asthma costs|Regression, Linear|||||-9|-19|<0.001
73827335|NCT01328964|147201325|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0495|TWO_SIDED|95.0|0.565|0.999||P-value is based on the comparison of combined endpoint of hospitalization/emergency department visits|Regression, Cox|||||0.999|0.565|0.0495
73827336|NCT01328964|147201326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-27.0||P-value is based on difference in total monthly asthma costs|Regression, Linear|||||-27|-28|<0.0001
73827337|NCT00944710|147201338|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.0||||0.33|TWO_SIDED|95.0|-10.0|30.0|||Binomial regression|adjusted for visual acuity at randomization||||30|-10|0.33
73827338|NCT00944710|147201343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.12|TWO_SIDED|95.0|-0.01|0.12|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.|Positive values favor the Intensified Treatment group|The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.||0.12|-0.01|0.12
73827339|NCT00944710|147201351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.55|TWO_SIDED|95.0|-0.23|0.43|||ANCOVA|||A treatment group difference in fellow-eye visual acuity change at the 12-week exam was evaluated using an ANCOVA model, adjusting for the fellow-eye visual acuity at randomization.||0.43|-0.23|0.55
73827340|NCT00944710|147201360|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.||||0.23
73827341|NCT00944710|147201361|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.||||0.66
73827342|NCT03044314|147201406|SUPERIORITY|||||||0.148|||||||t-test, 2 sided|||Null hypothesis: inhalation with iNO (the gold standard) would provide greater response than the comparator (iloprost).||||0.148
73827343|NCT03044314|147201408|SUPERIORITY|||||||0.346|||||||Fisher Exact|||Null hypothesis was that fewer patients receiving iloprost (new agent) would respond compared to iNO (the gold standard).||||0.346
73827344|NCT00264147|147201423|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.||||||<0.001
73827345|NCT00264147|147201423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.||||||0.057
73827346|NCT00264147|147201423|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|18.53||||||95.0|7.84|28.65|||||CI based on the Wilson's score method.|||28.65|7.84|
73827347|NCT00264147|147201423|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|10.0||||||95.0|-0.66|20.46|||||CI based on the Wilson's score method.|||20.46|-0.66|
73827348|NCT00264147|147201423|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|9.18||||||95.0|-1.25|19.39|||||CI based on the Wilson's score method.|||19.39|-1.25|
73827349|NCT00264147|147201423|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|6.49||||||95.0|-3.76|16.61|||||CI based on the Wilson's score method.|||16.61|-3.76|
73827350|NCT00264147|147201424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.002
73827351|NCT00264147|147201424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.221||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.221
73827352|NCT00264147|147201424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.06||||||95.0|-6.44|-1.68||||||||-1.68|-6.44|
73827353|NCT00264147|147201424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49||||||95.0|-3.91|0.93||||||||0.93|-3.91|
73827354|NCT00264147|147201424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.74||||||95.0|-5.13|-0.35||||||||-0.35|-5.13|
73827355|NCT00264147|147201424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||||95.0|-4.88|-0.12||||||||-0.12|-4.88|
73827356|NCT00264147|147201425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.001
73827357|NCT00264147|147201425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.125||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.125
73827358|NCT00264147|147201425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.24||||||95.0|-3.64|-0.84||||||||-0.84|-3.64|
73827359|NCT00264147|147201425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.02||||||95.0|-2.44|0.41||||||||0.41|-2.44|
73827360|NCT00264147|147201425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22||||||95.0|-2.63|0.18||||||||0.18|-2.63|
73827361|NCT00264147|147201425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49||||||95.0|-1.89|0.91||||||||0.91|-1.89|
73827362|NCT00264147|147201426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
73827363|NCT00264147|147201426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
73827364|NCT00264147|147201426|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
73827365|NCT00264147|147201426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.023
73827366|NCT00264147|147201426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.16||||||95.0|-19.38|-8.95||||||||-8.95|-19.38|
73827367|NCT00264147|147201426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.21||||||95.0|-14.52|-3.9||||||||-3.90|-14.52|
73827368|NCT00264147|147201426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.87||||||95.0|-14.11|-3.63||||||||-3.63|-14.11|
73827369|NCT00264147|147201426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.05||||||95.0|-11.27|-0.83||||||||-0.83|-11.27|
73827370|NCT00264147|147201427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
73827371|NCT00264147|147201427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
73827372|NCT00264147|147201427|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
73827373|NCT00264147|147201427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.018
73827374|NCT00264147|147201427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56||||||95.0|-0.77|-0.35||||||||-0.35|-0.77|
73827375|NCT00264147|147201427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.13||||||||-0.13|-0.55|
73827376|NCT00264147|147201427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||||95.0|-0.61|-0.19||||||||-0.19|-0.61|
73827377|NCT00264147|147201427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25||||||95.0|-0.46|-0.04||||||||-0.04|-0.46|
73827378|NCT00264147|147201428|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
73827379|NCT00264147|147201428|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.018
73827380|NCT00264147|147201428|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.017
73827381|NCT00264147|147201428|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.080
73827382|NCT00264147|147201428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.44||||||95.0|-19.62|-9.26||||||||-9.26|-19.62|
73827383|NCT00264147|147201428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.22||||||95.0|-11.52|-0.92||||||||-0.92|-11.52|
73827384|NCT00264147|147201428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.32||||||95.0|-11.53|-1.12||||||||-1.12|-11.53|
73827385|NCT00264147|147201428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.63||||||95.0|-9.81|0.55||||||||0.55|-9.81|
73827386|NCT02008526|147201453|SUPERIORITY||F|1.16||||0.3137|TWO_SIDED||||||ANOVA|2 Degrees of Freedom||||||0.3137
73827387|NCT02008526|147201454|SUPERIORITY||F|0.16||||0.8494|TWO_SIDED||||||ANOVA|2 Degrees of Freedom||||||0.8494
73827388|NCT00828711|147201466|SUPERIORITY_OR_OTHER||Difference in Proportions|12.2||||0.057|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|The primary objective of this study is to compare the efficacy of MVI 100 and MVI 200 based on the proportion of vaginal deliveries within 24 hours. A minimum sample size of approximately 120 subjects per arm would provide 84 subjects per arm with vaginal delivery, which would ensure \>80% power (with two-sided alpha of 5%) to detect a 20% improvement in the proportion of women delivering vaginally within 24 hours||||0.057
73827389|NCT00828711|147201467|SUPERIORITY_OR_OTHER||Median Difference (Net)|-563.0||||0.018|TWO_SIDED|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||0.018
73827390|NCT00828711|147201469|SUPERIORITY_OR_OTHER||Difference in Proportions|-8.46||||0.153|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - MVI 100|||||0.153
73827391|NCT00828711|147201470|SUPERIORITY_OR_OTHER||Difference in Proportions|2.37||||0.65|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|||||0.65
73827392|NCT00828711|147201471|SUPERIORITY_OR_OTHER||Difference in Proportions|-22.09|||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|||||<.001
73827393|NCT00828711|147201473|SUPERIORITY_OR_OTHER||Median Difference (Net)|-368.0||||0.007|TWO_SIDED|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdraw consent prior to delivery will be censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||0.007
73827394|NCT01618968|147201474|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.99|||||TWO_SIDED|90.0|121.61|134.7||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the last measurable concentration AUC(0-inf).||134.70|121.61|
73827395|NCT01618968|147201474|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|125.48|||||TWO_SIDED|90.0|119.43|131.84||||||To compare the relative bioavailability of MTX following oral administration to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-Inf).||131.84|119.43|
73827396|NCT01618968|147201474|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference ratio|101.85|||||TWO_SIDED|90.0|99.41|104.36||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-inf)||104.36|99.41|
73827397|NCT01618968|147201475|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.65|||||TWO_SIDED|90.0|121.28|134.36||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||134.36|121.28|
73827398|NCT01618968|147201475|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|125.2|||||TWO_SIDED|90.0|119.16|131.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||131.55|119.16|
73827399|NCT01618968|147201475|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|101.82|||||TWO_SIDED|90.0|99.39|104.31||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||104.31|99.39|
73827400|NCT01618968|147201476|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|94.83|||||TWO_SIDED|90.0|86.42|104.06||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||104.06|86.42|
73827401|NCT01618968|147201476|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|82.12|||||TWO_SIDED|90.0|76.16|88.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||88.55|76.16|
73827402|NCT01618968|147201476|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|115.63|||||TWO_SIDED|90.0|108.83|122.86||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||122.86|108.83|
73827403|NCT05994963|147201496|OTHER||Ratio of adjusted geometric means|58.84|||||TWO_SIDED|90.0|40.45|85.6|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||85.60|40.45|
73827404|NCT05994963|147201497|OTHER||Ratio of adjusted geometric means|56.93|||||TWO_SIDED|90.0|38.71|83.73|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||83.73|38.71|
73827405|NCT05994963|147201498|OTHER||Ratio of adjusted geometric means|50.13|||||TWO_SIDED|90.0|33.01|76.13|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||76.13|33.01|
73827406|NCT05994963|147201499|OTHER||Ratio of adjusted geometric means|202.52|||||TWO_SIDED|90.0|138.43|296.27|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||296.27|138.43|
73827407|NCT05994963|147201500|OTHER||Ratio of adjusted geometric means|196.11|||||TWO_SIDED|90.0|131.01|293.55|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||293.55|131.01|
73827408|NCT05994963|147201501|OTHER||Ratio of adjusted geometric means|230.22|||||TWO_SIDED|90.0|145.53|364.2|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||364.20|145.53|
73827409|NCT05994963|147201502|OTHER||Ratio of adjusted geometric means|122.84|||||TWO_SIDED|90.0|93.61|161.19|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||161.19|93.61|
73827410|NCT05994963|147201503|OTHER||Ratio of adjusted geometric means|104.69|||||TWO_SIDED|90.0|94.54|115.94|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||115.94|94.54|
73827411|NCT05994963|147201504|OTHER||Ratio of adjusted geometric means|124.59|||||TWO_SIDED|90.0|93.46|166.09|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||166.09|93.46|
73827412|NCT02100124|147201521|SUPERIORITY||Odds Ratio (OR)|0.87||||1|TWO_SIDED|95.0|0.56|1.36|||Regression, Logistic|||||1.36|0.56|1.0
73827413|NCT02100124|147201521|SUPERIORITY||Odds Ratio (OR)|1.13||||1|TWO_SIDED|95.0|0.7|1.83|||Regression, Logistic|||||1.83|0.70|1.0
73827414|NCT02100124|147201521|SUPERIORITY||Odds Ratio (OR)|1.3||||0.53|TWO_SIDED|95.0|0.82|2.08|||Regression, Logistic|||||2.08|0.82|0.53
73827415|NCT02100124|147201522|SUPERIORITY||Odds Ratio (OR)|0.88||||0.48|TWO_SIDED|95.0|0.71|1.09|||Regression, Logistic|||||1.09|0.71|0.48
73827416|NCT02100124|147201522|SUPERIORITY||Odds Ratio (OR)|1.08||||1|TWO_SIDED|95.0|0.87|1.35|||Regression, Logistic|||||1.35|0.87|1.0
73827417|NCT02100124|147201522|SUPERIORITY||Odds Ratio (OR)|1.23||||0.07|TWO_SIDED|95.0|0.99|1.53|||Regression, Logistic|||||1.53|0.99|0.07
73827418|NCT02100124|147201523|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.84|1.29|||Regression, Logistic|||||1.29|0.84|1.0
73827419|NCT02100124|147201523|SUPERIORITY||Odds Ratio (OR)|1.02||||1|TWO_SIDED|95.0|0.82|1.26|||Regression, Logistic|||||1.26|0.82|1.0
73827420|NCT02100124|147201523|SUPERIORITY||Odds Ratio (OR)|0.98||||1|TWO_SIDED|95.0|0.79|1.22|||Regression, Logistic|||||1.22|0.79|1.0
73827421|NCT02100124|147201524|SUPERIORITY||Odds Ratio (OR)|1.07||||1|TWO_SIDED|95.0|0.83|1.37|||Regression, Logistic|||||1.37|0.83|1.0
73827422|NCT02100124|147201524|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.81|1.33|||Regression, Logistic|||||1.33|0.81|1.0
73827423|NCT02100124|147201524|SUPERIORITY||Odds Ratio (OR)|0.97||||1|TWO_SIDED|95.0|0.75|1.25|||Regression, Logistic|||||1.25|0.75|1.0
73827424|NCT00408499|147201551|OTHER|Maximum tolerated dose was derived from toxicity data obtained from dose level 1-4.|Maximum tolerated dose|4.0|||||TWO_SIDED||||||||Maximum tolerated dose was determined to be dose level 4: 150 mg Erlotinib, 250 mg/m2 Cetuximab|||||
73827425|NCT02543840|147201587|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.01|TWO_SIDED|95.0|-1.26|1.5||Adjusted for multiple comparisons (Bonferroni four comparisons).|Mixed Models Analysis|||||1.5|-1.26|<0.01
73827426|NCT02543840|147201587|SUPERIORITY||Mean Difference (Final Values)|5.03|||<|0.001|TWO_SIDED|95.0|2.24|7.82||Adjusted for comparisons (Bonferroni for 4 comparisons.)|Regression, Linear|||Among Veteran participants,we used a linear contrast comparing a) those with complex clinical presentations, defined as receiving treatment for three or more mental health diagnoses in the prior year to b) those with two or fewer diagnoses during the facilitation year from T0 to T12..||7.82|2.24|<0.001
73827427|NCT02543840|147201588|SUPERIORITY||Mean Difference (Final Values)|1.2|||<|0.04|TWO_SIDED|95.0|0.04|2.3||Adjusted for comparison (Bonferroni for four comparisons.)|Mixed Models Analysis|||||2.3|0.04|<0.04
73827428|NCT02543840|147201589|SUPERIORITY||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED|95.0|-0.2|0.9|||Mixed Models Analysis|||||0.9|-0.2|>0.05
73827429|NCT02543840|147201590|SUPERIORITY||Mean Difference (Final Values)|0.5|||>|0.05|TWO_SIDED|95.0|-1.3|2.3|||Mixed Models Analysis|||||2.3|-1.3|>0.05
73827430|NCT02543840|147201591|SUPERIORITY||Mean Difference (Final Values)|0.0|||>|0.05|TWO_SIDED|95.0|-0.6|0.8|||Mixed Models Analysis|||||0.8|-0.6|>0.05
73827431|NCT02543840|147201592|SUPERIORITY||Mean Difference (Final Values)|0.005|||>|0.05|TWO_SIDED|95.0|-0.074|0.084|||t-test, 2 sided|Paired.||||0.084|-0.074|>0.05
73827432|NCT02543840|147201593|SUPERIORITY||Mean Difference (Final Values)|0.011|STANDARD_DEVIATION|0.206|>|0.05|TWO_SIDED|95.0|-0.056|0.077|||t-test, 2 sided|Paired.||||0.077|-0.056|>0.05
73827433|NCT02543840|147201594|SUPERIORITY||Mean Difference (Final Values)|0.153|||<|0.001|TWO_SIDED|95.0|0.044|0.262|||t-test, 2 sided|Paired||||0.262|0.044|<0.001
73827434|NCT02543840|147201595|SUPERIORITY||Mean Difference (Final Values)|0.186|||<|0.01|TWO_SIDED|95.0|0.083|0.289|||t-test, 2 sided|Paired.||||0.289|0.083|<0.01
73827435|NCT02543840|147201596|SUPERIORITY||Mean Difference (Final Values)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.16|-0.07||Repeated patient binary outcome models for hospitalized (0/1) across 8 quarters.|Mixed Models Analysis|Adjusted (Bonferroni four comparisons).||||-0.07|-0.16|<0.001
73827436|NCT04745351|147201597|SUPERIORITY||Hazard Ratio (HR)|0.816||||0.6132|TWO_SIDED|95.0|0.504|1.321||P-value was calculated from stratified log-rank test, stratified by the baseline stratification factors.|Log Rank|||||1.321|0.504|0.6132
73827437|NCT04745351|147201598|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3881|TWO_SIDED|95.0|0.497|1.388||P-value was calculated from stratified log-rank test stratified by the baseline stratification factors.|Log Rank|||||1.388|0.497|0.3881
73827438|NCT04745351|147201599|SUPERIORITY||Hazard Ratio (HR)|1.043||||0.9116|TWO_SIDED|95.0|0.493|2.207||The treatment effect p-value was calculated using Cox model with death as the competing risk and baseline stratification factors as covariates.|Regression, Cox|||||2.207|0.493|0.9116
73827439|NCT04745351|147201602|SUPERIORITY|||||||0.8541||||||P-value was analysed from proportional odds model including treatment as the independent variable.|Proportional odds model|||||||0.8541
73827440|NCT04745351|147201603|SUPERIORITY|||||||0.4974||||||P-value was analysed from proportional odds model including treatment as the independent variable.|Proportional odds model|||||||0.4974
73827441|NCT04745351|147201604|SUPERIORITY|||||||0.4283||||||P-value was calculated based on Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||||||0.4283
73827442|NCT04745351|147201605|SUPERIORITY||Relative risk|0.89||||0.2773|TWO_SIDED|95.0|0.731|1.091||The treatment effect p-value was calculated using Cochran-Mantel-Haenszel (CMH) analysis including baseline stratification factors.|Cochran-Mantel-Haenszel|||||1.091|0.731|0.2773
73827443|NCT04745351|147201606|SUPERIORITY||Relative risk|0.97||||0.7538|TWO_SIDED|95.0|0.819|1.155||The treatment effect p-value was calculated using CMH analysis including baseline stratification factors.|Cochran-Mantel-Haenszel|||||1.155|0.819|0.7538
73827444|NCT03845894|147201616|NON_INFERIORITY|There have been no studies to evaluate pain scores ISB w/ plain bupi+adjuvants. Power to detect difference at least 0.4 on the VAS scale. Threshold for inferiority is difference \>=2 points on the VAS scale. Will use two-sample t test with α= 0.05 and β= 0.1. Postop opioid consumption, total post-op opioid @ 1st 48 hours in oxycodone equivalents. Mean opioid consumption per cohort is calculated, \& the cohorts compared for statistical difference with two-sample t test, with α= 0.05 and β= 0.1.||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
73827445|NCT00879190|147201619|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
73827446|NCT00879190|147201620|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
73827447|NCT00879190|147201621|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||||||0.6
73827448|NCT01248455|147201622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||No patients obtained a 50% reduction in M-protein concentration and the study did not continue to the second stage of enrollment due to the lack of efficacy as defined by out criteria. This statistical analysis includes all participants (i.e., stable disease (SD), minimal response (MR), biochemical progression (BP), and progressive disease (PD)).||||0.56
73827449|NCT02709746|147201655|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.4702|TWO_SIDED|95.0|-1.94|4.2|||Mixed Model Repeated Analysis|||||4.2|-1.94|0.4702
73827450|NCT02709746|147201655|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.6373|TWO_SIDED|95.0|-3.71|2.27|||Mixed Model Repeated Analysis|||||2.27|-3.71|0.6373
73827451|NCT02709746|147201655|SUPERIORITY||Mean Difference (Final Values)|-3.73||||0.0152|TWO_SIDED|95.0|-6.74|-0.72|||Mixed Model Repeated Analysis|||||-0.72|-6.74|0.0152
73827452|NCT02709746|147201655|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.8778|TWO_SIDED|95.0|-2.41|2.82|||Mixed Model Repeated Analysis|||||2.82|-2.41|0.8778
73827453|NCT02497469|147201721|SUPERIORITY||Adjusted Difference|8.8||||0.0061|TWO_SIDED|95.0|2.5|15.0|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|15.0|2.5|0.0061
73827454|NCT02497469|147201722|SUPERIORITY||Adjusted Difference|11.9||||0.0005|TWO_SIDED|95.0|5.3|18.5|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|18.5|5.3|0.0005
73827455|NCT02497469|147201723|SUPERIORITY||Adjusted Difference|-9.3||||0.0641|TWO_SIDED|95.0|-18.9|0.4|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|0.4|-18.9|0.0641
73827456|NCT01026493|147201734|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.66|1.48|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-NAIVE|||1.48|0.66|0.95
73827457|NCT01026493|147201734|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.93|TWO_SIDED|95.0|0.57|1.53|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-FAILURE|||1.53|0.57|0.93
73827458|NCT00289211|147201735|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.048||||0.048||95.0|1.008|4.164|||Regression, Cox|||Subjects who did not experience beginning of substantial relief of the defining symptom within 4 hours after initial treatment were included in the analysis as censored observations. Entries of 4.0 (hours) for median time to event or 95% CI indicate that data were NE (see Population Description). As non-numeric data are not supported by the median and 95% CI fields, entry of the actual results (ie, NE or \>4.0) was not possible.||4.164|1.008|0.048
73827459|NCT00289211|147201736|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.41||||0.062||95.0|0.87|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.87|0.062
73827460|NCT00289211|147201737|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.717||||0.001||95.0|1.471|5.02|||Regression, Cox|||Subjects who had not experienced complete resolution of the HAE attack at the time of the follow-up telephone call, or who were lost to follow-up, were censored at 72 hours.||5.020|1.471|0.001
73827461|NCT00289211|147201738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73827462|NCT00289211|147201738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73827463|NCT00289211|147201738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73827464|NCT00289211|147201738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0007
73827465|NCT00289211|147201739|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73827466|NCT00289211|147201739|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73827467|NCT00289211|147201739|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
73827468|NCT00289211|147201739|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022||95.0||||Percent change 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0022
73827469|NCT00289211|147201740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1321||95.0||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.1321
73827470|NCT00289211|147201740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5218||95.0||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.5218
73827471|NCT00289211|147201740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.121||95.0||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.1210
73827472|NCT00289211|147201740|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0017
73827473|NCT02295644|147201750|SUPERIORITY_OR_OTHER|||||||0.17||||||Interaction test of duty cycle and intensity for self reported pain score|ANOVA|||||||0.17
73827474|NCT02295644|147201750|SUPERIORITY_OR_OTHER|||||||0.14||||||Main effect of duty cycle on self reported pain score.|ANOVA|||||||0.14
73827475|NCT02295644|147201750|SUPERIORITY_OR_OTHER|||||||1||||||Main effect of intensity on self reported pain score.|ANOVA|||||||1.0
73827476|NCT02295644|147201751|SUPERIORITY_OR_OTHER|||||||0.24||||||Main effect for duty cycle.|ANOVA|||||||.24
73827477|NCT02295644|147201751|SUPERIORITY_OR_OTHER|||||||0.019||||||Main effect for intensity.|ANOVA|||||||0.019
73827478|NCT02295644|147201751|SUPERIORITY_OR_OTHER|||||||0.17|||||||ANOVA|||Interaction of intensity and duty cycle.||||0.17
73827479|NCT02295644|147201752|SUPERIORITY_OR_OTHER|||||||0.034||||||Main effect for duty cycle.|ANOVA|||||||0.034
73827480|NCT02295644|147201752|SUPERIORITY_OR_OTHER|||||||0.475|||||||ANOVA|||Main effect for intensity.||||0.475
73827481|NCT02295644|147201752|SUPERIORITY_OR_OTHER|||||||0.178|||||||ANOVA|||Interaction of intensity and duty cycle.||||.178
73827482|NCT00324155|147201754|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.4067|TWO_SIDED|95.0|0.799|1.74|||Cochran-Mantel-Haenszel|Stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and ECOG performance status (0 vs 1) recorded at randomization.||Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1) recorded at randomization.||1.740|0.799|0.4067
73827483|NCT00324155|147201762|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.716||||0.0009|TWO_SIDED|95.0|0.588|0.872||p-value was via stratified log-rank test|Log Rank||Hazard ratio via stratified Cox proportional hazards model.|Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group performance status (0 vs 1) recorded at randomization.||0.872|0.588|0.0009
73827484|NCT05412134|147201767|OTHER|||||||0.333|||||||Chi-squared|||Repetition adherence||||0.333
73827485|NCT05412134|147201767|OTHER|||||||0.626|||||||Chi-squared|||Session adherence||||0.626
73827486|NCT05412134|147201768|SUPERIORITY|||||||0.416|||||||Wilcoxon (Mann-Whitney)|||||||0.416
73827487|NCT05412134|147201769|SUPERIORITY|||||||0.581|||||||t-test, 2 sided|||||||0.581
73827488|NCT05412134|147201770|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||||||0.071
73827489|NCT05412134|147201771|SUPERIORITY|||||||0.356|||||||t-test, 2 sided|||||||0.356
73827490|NCT05412134|147201773|SUPERIORITY|||||||0.079|||||||t-test, 2 sided|||||||0.079
73827491|NCT01578772|147201793|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|||<|0.05|TWO_SIDED|95.0|-0.1|0.1|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.||||0.1|-0.1|<0.05
73827492|NCT01578772|147201794|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.7|||<|0.05|TWO_SIDED|95.0|-1.3|1.9|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.||||1.9|-1.3|<0.05
73827493|NCT00808340|147201813|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5.|Mean Difference (Final Values)|-0.1249|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.4143|0.1644|||Mixed Models Analysis||Mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.1644|-0.4143|
73827494|NCT00808340|147201813|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3693|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.6587|-0.07996|||Mixed Models Analysis||The mean difference was calculated as balafilcon A multifocal minus senofilcon A multifocal prod.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.07996|-0.6587|
73827495|NCT00808340|147201814|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.04083|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.2485|0.3302|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.3302|-0.2485|
73827496|NCT00808340|147201814|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.4608|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.7502|-0.1714|||Mixed Models Analysis||The mean difference was calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.1714|-0.7502|
73827497|NCT00808340|147201815|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.02941|STANDARD_ERROR_OF_MEAN|0.02656|||TWO_SIDED|97.5|-0.08153|0.02271|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.02271|-0.08153|
73827498|NCT00808340|147201815|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.06765|STANDARD_ERROR_OF_MEAN|0.02656|||TWO_SIDED|97.5|-0.1198|-0.01553|||Mixed Models Analysis||The mean difference is calculated as senfilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.01553|-0.1198|
73827499|NCT00808340|147201816|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3304|STANDARD_ERROR_OF_MEAN|0.2243|||TWO_SIDED|97.5|-0.779|0.1183|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hyposthesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.1183|-0.779|
73827500|NCT00808340|147201816|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.2281|STANDARD_ERROR_OF_MEAN|0.2243|||TWO_SIDED|97.5|-0.6767|0.2206|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternativie hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||0.2206|-0.6767|
73827501|NCT02175121|147201827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-40.33|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|90.0|-51.49|-29.16||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-29.16|-51.49|<0.0001
73827502|NCT02175121|147201827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.53|STANDARD_ERROR_OF_MEAN|6.98|<|0.0001|TWO_SIDED|90.0|-57.08|-33.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-33.99|-57.08|<0.0001
73827503|NCT02175121|147201827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.79|STANDARD_ERROR_OF_MEAN|6.73|<|0.0001|TWO_SIDED|90.0|-79.92|-57.65||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-57.65|-79.92|<0.0001
73827504|NCT02175121|147201827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.12|STANDARD_ERROR_OF_MEAN|6.86|<|0.0001|TWO_SIDED|90.0|-79.46|-56.78||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-56.78|-79.46|<0.0001
73827505|NCT02175121|147201828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.25|STANDARD_ERROR_OF_MEAN|5.83||0.006|TWO_SIDED|90.0|-25.9|-6.6||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-6.60|-25.90|0.0060
73827506|NCT02175121|147201828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.98|STANDARD_ERROR_OF_MEAN|5.94|<|0.0001|TWO_SIDED|90.0|-36.81|-17.15||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-17.15|-36.81|<0.0001
73827507|NCT02175121|147201828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-39.6|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|90.0|-49.2|-30.0||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-30.00|-49.20|<0.0001
73827508|NCT02175121|147201828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.72|STANDARD_ERROR_OF_MEAN|5.89|<|0.0001|TWO_SIDED|90.0|-56.46|-36.98||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-36.98|-56.46|<0.0001
73827509|NCT02175121|147201828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.07|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|90.0|-35.89|-18.25||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-18.25|-35.89|<0.0001
73827510|NCT02175121|147201828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.18|STANDARD_ERROR_OF_MEAN|5.46|<|0.0001|TWO_SIDED|90.0|-45.21|-27.14||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-27.14|-45.21|<0.0001
73827511|NCT02175121|147201828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-51.47|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|90.0|-60.29|-42.65||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-42.65|-60.29|<0.0001
73827512|NCT02175121|147201828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.17|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|90.0|-66.12|-48.22||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-48.22|-66.12|<0.0001
73827513|NCT02175121|147201829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.86|STANDARD_ERROR_OF_MEAN|10.13||0.2063|TWO_SIDED|90.0|-3.91|29.62||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||29.62|-3.91|0.2063
73827514|NCT02175121|147201829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.03|STANDARD_ERROR_OF_MEAN|10.33||0.2087|TWO_SIDED|90.0|-4.05|30.11||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||30.11|-4.05|0.2087
73827515|NCT02175121|147201829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|10.1||0.5802|TWO_SIDED|90.0|-11.11|22.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||22.30|-11.11|0.5802
73827516|NCT02175121|147201829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.64|STANDARD_ERROR_OF_MEAN|10.25||0.1553|TWO_SIDED|90.0|-2.32|31.59||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||31.59|-2.32|0.1553
73827517|NCT02175121|147201829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|7.66||0.7741|TWO_SIDED|90.0|-14.87|10.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||10.47|-14.87|0.7741
73827518|NCT02175121|147201829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|7.78||0.9588|TWO_SIDED|90.0|-13.28|12.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||12.47|-13.28|0.9588
73827519|NCT02175121|147201829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.42|STANDARD_ERROR_OF_MEAN|7.61||0.8523|TWO_SIDED|90.0|-11.17|14.01||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||14.01|-11.17|0.8523
73827520|NCT02175121|147201829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.3|STANDARD_ERROR_OF_MEAN|7.73||0.4166|TWO_SIDED|90.0|-6.49|19.08||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||19.08|-6.49|0.4166
73827521|NCT02175121|147201830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|3.22||0.8516|TWO_SIDED|90.0|-4.73|5.93||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||5.93|-4.73|0.8516
73827522|NCT02175121|147201830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.97|STANDARD_ERROR_OF_MEAN|3.29||0.2303|TWO_SIDED|90.0|-1.48|9.42||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||9.42|-1.48|0.2303
73827523|NCT02175121|147201830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19|STANDARD_ERROR_OF_MEAN|3.22||0.7132|TWO_SIDED|90.0|-4.15|6.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.52|-4.15|0.7132
73827524|NCT02175121|147201830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74|STANDARD_ERROR_OF_MEAN|3.28||0.0034|TWO_SIDED|90.0|4.32|15.16||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||15.16|4.32|0.0034
73827525|NCT02175121|147201830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99|STANDARD_ERROR_OF_MEAN|2.96||0.7394|TWO_SIDED|90.0|-5.89|3.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||3.92|-5.89|0.7394
73827526|NCT02175121|147201830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|3.03||0.8652|TWO_SIDED|90.0|-4.5|5.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.53|-4.50|0.8652
73827527|NCT02175121|147201830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.61|STANDARD_ERROR_OF_MEAN|2.97||0.837|TWO_SIDED|90.0|-4.3|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.52|-4.30|0.8370
73827528|NCT02175121|147201830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.59|STANDARD_ERROR_OF_MEAN|3.01||0.0018|TWO_SIDED|90.0|4.6|14.58||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||14.58|4.60|0.0018
73827529|NCT02175121|147201831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.12|STANDARD_ERROR_OF_MEAN|4.25||0.6182|TWO_SIDED|90.0|-9.15|4.91||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||4.91|-9.15|0.6182
73827530|NCT02175121|147201831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|4.34||0.7028|TWO_SIDED|90.0|-5.52|8.84||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||8.84|-5.52|0.7028
73827531|NCT02175121|147201831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|4.25||0.9445|TWO_SIDED|90.0|-7.33|6.73||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.73|-7.33|0.9445
73827532|NCT02175121|147201831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.07|STANDARD_ERROR_OF_MEAN|4.32||0.0373|TWO_SIDED|90.0|1.93|16.21||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||16.21|1.93|0.0373
73827533|NCT02175121|147201831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|4.21||0.9448|TWO_SIDED|90.0|-7.25|6.67||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.67|-7.25|0.9448
73827534|NCT02175121|147201831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|4.3||0.9312|TWO_SIDED|90.0|-6.74|7.49||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.49|-6.74|0.9312
73827535|NCT02175121|147201831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|4.21||0.9791|TWO_SIDED|90.0|-7.07|6.85||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.85|-7.07|0.9791
73827536|NCT02175121|147201831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.34|STANDARD_ERROR_OF_MEAN|4.28||0.0044|TWO_SIDED|90.0|5.26|19.41||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||19.41|5.26|0.0044
73827537|NCT02175121|147201832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.77|STANDARD_ERROR_OF_MEAN|3.96||0.6553|TWO_SIDED|90.0|-4.78|8.33||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||8.33|-4.78|0.6553
73827538|NCT02175121|147201832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.61|STANDARD_ERROR_OF_MEAN|4.05||0.2569|TWO_SIDED|90.0|-2.09|11.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||11.30|-2.09|0.2569
73827539|NCT02175121|147201832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.64|STANDARD_ERROR_OF_MEAN|3.96||0.0553|TWO_SIDED|90.0|1.09|14.18||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||14.18|1.09|0.0553
73827540|NCT02175121|147201832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.89|STANDARD_ERROR_OF_MEAN|4.01||0.0016|TWO_SIDED|90.0|6.26|19.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||19.53|6.26|0.0016
73827541|NCT02175121|147201832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|3.58||0.8717|TWO_SIDED|90.0|-5.35|6.51||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.51|-5.35|0.8717
73827542|NCT02175121|147201832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|3.66||0.743|TWO_SIDED|90.0|-4.86|7.26||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.26|-4.86|0.7430
73827543|NCT02175121|147201832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|3.58||0.2041|TWO_SIDED|90.0|-1.36|10.48||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||10.48|-1.36|0.2041
73827544|NCT02175121|147201832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.92|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|90.0|8.92|20.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||20.92|8.92|<0.0001
73827545|NCT02175121|147201833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|4.08||0.975|TWO_SIDED|90.0|-6.62|6.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.87|-6.62|0.9750
73827546|NCT02175121|147201833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.99|STANDARD_ERROR_OF_MEAN|4.16||0.3396|TWO_SIDED|90.0|-2.9|10.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||10.87|-2.90|0.3396
73827547|NCT02175121|147201833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.49|STANDARD_ERROR_OF_MEAN|4.07||0.7142|TWO_SIDED|90.0|-8.23|5.24||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||5.24|-8.23|0.7142
73827548|NCT02175121|147201833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.78|STANDARD_ERROR_OF_MEAN|4.14||0.0192|TWO_SIDED|90.0|2.94|16.63||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||16.63|2.94|0.0192
73827549|NCT02175121|147201833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|3.85||0.8277|TWO_SIDED|90.0|-7.2|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.52|-7.20|0.8277
73827550|NCT02175121|147201833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|3.93||0.8857|TWO_SIDED|90.0|-5.93|7.06||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.06|-5.93|0.8857
73827551|NCT02175121|147201833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|3.84||0.8824|TWO_SIDED|90.0|-6.93|5.79||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.79|-6.93|0.8824
73827552|NCT02175121|147201833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.23|STANDARD_ERROR_OF_MEAN|3.9||0.0192|TWO_SIDED|90.0|2.77|15.69||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||15.69|2.77|0.0192
73827553|NCT01251042|147201887|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Information about the size of the standard deviation (SD) for the change was obtained from an earlier study. The SD for the change from pre-operation until 24 hours after start of transfusion was 0.2305. Due to the imprecise measuring device (if values below 0.3 g/l) and the large SD, a non-inferiority margin (∆) of 0.2 g/l was decided to be used in this study, resulting in a total number of 42 evaluable subjects, i.e. 21 subjects per group.||||||0.6294||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6294
73827554|NCT00269152|147201896|SUPERIORITY_OR_OTHER||Feasibility Response Rate (percentage)|59.4|||||TWO_SIDED|95.0|46.4|71.5||||||||71.5|46.4|
73827555|NCT00269152|147201896|SUPERIORITY_OR_OTHER||Feasibility Response Rate (percentage)|50.0||||||95.0|36.1|63.9||||||||63.9|36.1|
73827556|NCT03886272|147201901|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|112.96||||0.0413|TWO_SIDED|90.0|102.7|124.26||P-value for ratio outside 80% -125%.|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as: T1/R1. Intra-individual geometric coefficient of variation (gCV) = 14.2|Relative bioavailability||124.26|102.70|0.0413
73827557|NCT03886272|147201901|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|115.49||||0.0776|TWO_SIDED|90.0|105.23|126.74||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T2/R2. Intra-individual geometric coefficient of variation (gCV) = 13.9.|Relative bioavailability||126.74|105.23|0.0776
73827558|NCT03886272|147201901|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|78.05||||0.6443|TWO_SIDED|90.0|69.71|87.38||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as Tc3/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative bioavailability||87.38|69.71|0.6443
73827559|NCT03886272|147201901|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|45.97||||1|TWO_SIDED|90.0|41.05|51.48||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T3u/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative bioavailability||51.48|41.05|1.00
73827560|NCT03886272|147201902|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|144.62||||0.9485|TWO_SIDED|90.0|124.82|167.57||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T1/R1. Intra-individual geometric coefficient of variation (gCV) = 22.1|Relative bioavailability||167.57|124.82|0.9485
73827561|NCT03886272|147201902|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|129.69||||0.7813|TWO_SIDED|90.0|119.51|140.73||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The adjusted geometric mean is geometric mean adjusted by treatment. Ratio is calculated as T2/R2. Intra-individual geometric coefficient of variation (gCV) = 12.2.|Relative Bioavailability||140.73|119.51|0.7813
73827562|NCT03886272|147201902|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|75.09||||0.7616|TWO_SIDED|90.0|64.58|87.32||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3c/3. Intra-individual geometric coefficient of variation (gCV) = 23.5.|Relative Bioavailability||87.32|64.58|0.7616
73827563|NCT03886272|147201902|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|41.45||||1|TWO_SIDED|90.0|35.61|48.25||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3u/R3. Intra-individual geometric coefficient of variation = 23.5.|Relative Bioavailability||48.25|35.61|1.00
73827564|NCT03886272|147201903|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|111.11|STANDARD_DEVIATION|11.5||0.0092|TWO_SIDED|90.0|102.87|120.01||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T1/R1. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||120.01|102.87|0.0092
73827565|NCT03886272|147201903|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|114.13||||0.0442|TWO_SIDED|90.0|104.58|124.56||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T2/R2. Intra-individual geometric coefficient of variation (gCV) = 13.0.|Relative Bioavailability||124.56|104.58|0.0442
73827566|NCT03886272|147201903|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|80.1||||0.4928|TWO_SIDED|90.0|71.54|89.68||P-value for ratio outside 80% - 125%|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3c/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||89.68|71.54|0.4928
73827567|NCT03886272|147201903|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|48.83||||1|TWO_SIDED|90.0|43.6|54.69||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T3u/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||54.69|43.60|1.00
73827568|NCT02557399|147201904|SUPERIORITY_OR_OTHER||difference in percent|-6.83||||0.008|TWO_SIDED|95.0|-11.88|-1.78||The analysis method was mixed model repeated measures analysis with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.78|-11.88|0.008
73827569|NCT02557399|147201905|SUPERIORITY_OR_OTHER||difference in percent|-0.25||||0.916|TWO_SIDED|95.0|-4.85|4.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1|||4.35|-4.85|0.916
73827570|NCT02557399|147201905|SUPERIORITY_OR_OTHER||difference in percent|-5.85||||0.01|TWO_SIDED|95.0|-10.29|-1.42||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4|||-1.42|-10.29|0.010
73827571|NCT02557399|147201905|SUPERIORITY_OR_OTHER||difference in percent|-2.35||||0.257|TWO_SIDED|95.0|-6.42|1.72||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8|||1.72|-6.42|0.257
73827572|NCT02557399|147201905|SUPERIORITY_OR_OTHER||difference in percent|-3.24||||0.062|TWO_SIDED|95.0|-6.64|0.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12|||0.16|-6.64|0.062
73827573|NCT02557399|147201906|SUPERIORITY_OR_OTHER||difference in percent|-5.08||||0.115|TWO_SIDED|95.0|-11.41|1.25||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.25|-11.41|0.115
73827574|NCT02557399|147201906|SUPERIORITY_OR_OTHER||difference in percent|-8.43||||0.005|TWO_SIDED|95.0|-14.35|-2.51||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-2.51|-14.35|0.005
73827575|NCT02557399|147201906|SUPERIORITY_OR_OTHER||difference in percent|-9.37|||<|0.001|TWO_SIDED|95.0|-14.42|-4.33||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-4.33|-14.42|<0.001
73827576|NCT02557399|147201906|SUPERIORITY_OR_OTHER||difference in percent|-6.69||||0.004|TWO_SIDED|95.0|-11.21|-2.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-2.16|-11.21|0.004
73827577|NCT02557399|147201906|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5||||0.015|TWO_SIDED|95.0|-8.1|-0.89||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs|||-0.89|-8.10|0.015
73827578|NCT02557399|147201906|SUPERIORITY_OR_OTHER||difference in percent|2.71||||0.382|TWO_SIDED|95.0|-3.38|8.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||8.80|-3.38|0.382
73827579|NCT02557399|147201906|SUPERIORITY_OR_OTHER||difference in percent|-5.69||||0.085|TWO_SIDED|95.0|-12.17|0.78||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.78|-12.17|0.085
73827580|NCT02557399|147201906|SUPERIORITY_OR_OTHER||difference in percent|-3.89||||0.186|TWO_SIDED|95.0|-9.67|1.88||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.88|-9.67|0.186
73827581|NCT02557399|147201906|SUPERIORITY_OR_OTHER||difference in percent|-0.59||||0.818|TWO_SIDED|95.0|-5.61|4.44||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.44|-5.61|0.818
73827582|NCT02557399|147201906|SUPERIORITY_OR_OTHER||difference in percent|-3.78||||0.073|TWO_SIDED|95.0|-7.92|0.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.35|-7.92|0.073
73827583|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.961|TWO_SIDED|95.0|-4.6|4.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.4|-4.6|0.961
73827584|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.2||||0.015|TWO_SIDED|95.0|-11.2|-1.2||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.2|-11.2|0.015
73827585|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.044|TWO_SIDED|95.0|-9.2|-0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.1|-9.2|0.044
73827586|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.747|TWO_SIDED|95.0|-4.9|3.5||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||3.5|-4.9|0.747
73827587|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.338|TWO_SIDED|95.0|-5.3|1.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.8|-5.3|0.338
73827588|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.068|TWO_SIDED|95.0|-3.8|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.1|-3.8|0.068
73827589|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.002|TWO_SIDED|95.0|-4.8|-1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.1|-4.8|0.002
73827590|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.002|TWO_SIDED|95.0|-4.3|-1.0||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.0|-4.3|0.002
73827591|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.012|TWO_SIDED|95.0|-3.4|-0.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.4|-3.4|0.012
73827592|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.078|TWO_SIDED|95.0|-2.4|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.1|-2.4|0.078
73827593|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.367|TWO_SIDED|95.0|-2.1|5.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||5.7|-2.1|0.367
73827594|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1||||0.148|TWO_SIDED|95.0|-7.4|1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.1|-7.4|0.148
73827595|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.314|TWO_SIDED|95.0|-5.9|1.9||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.9|-5.9|0.314
73827596|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2||||0.494|TWO_SIDED|95.0|-2.3|4.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.7|-2.3|0.494
73827597|NCT02557399|147201907|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.684|TWO_SIDED|95.0|-3.5|2.3||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||2.3|-3.5|0.684
73827598|NCT02557399|147201908|SUPERIORITY_OR_OTHER||Difference in percentage|2.3||||0.047|TWO_SIDED|95.0|0.1|4.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1.The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||4.6|0.1|0.047
73827599|NCT02557399|147201908|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.185|TWO_SIDED|95.0|-1.3|7.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||7.3|-1.3|0.185
73827600|NCT02557399|147201908|SUPERIORITY_OR_OTHER||Difference in percentage|3.7||||0.251|TWO_SIDED|95.0|-2.5|9.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||9.9|-2.5|0.251
73827601|NCT02557399|147201908|SUPERIORITY_OR_OTHER||Difference in percentage|10.2||||0.006|TWO_SIDED|95.0|2.4|18.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||18.0|2.4|0.006
73827602|NCT02557399|147201908|SUPERIORITY_OR_OTHER||Difference in percentage|10.7||||0.022|TWO_SIDED|95.0|0.9|20.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||20.4|0.9|0.022
73827603|NCT02557399|147201909|SUPERIORITY_OR_OTHER||Difference in percentage|1.8||||0.129|TWO_SIDED|95.0|-0.7|4.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||4.3|-0.7|0.129
73827604|NCT02557399|147201909|SUPERIORITY_OR_OTHER||Difference in percentage|1.3||||0.612|TWO_SIDED|95.0|-3.4|5.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||5.9|-3.4|0.612
73827605|NCT02557399|147201909|SUPERIORITY_OR_OTHER||Difference in percentage|7.1||||0.016|TWO_SIDED|95.0|1.1|13.2||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||13.2|1.1|0.016
73827606|NCT02557399|147201909|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.034|TWO_SIDED|95.0|0.3|15.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||15.5|0.3|0.034
73827607|NCT02557399|147201909|SUPERIORITY_OR_OTHER||Difference in percentage|11.3||||0.018|TWO_SIDED|95.0|1.4|21.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||21.3|1.4|0.018
73827608|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|3.9||||0.379|TWO_SIDED|95.0|-4.5|12.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||12.3|-4.5|0.379
73827609|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|4.7||||0.409|TWO_SIDED|95.0|-5.7|15.1||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||15.1|-5.7|0.409
73827610|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|7.0||||0.18|TWO_SIDED|95.0|-3.1|17.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||17.0|-3.1|0.180
73827611|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|-0.5||||0.81|TWO_SIDED|95.0|-8.8|7.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||7.7|-8.8|0.810
73827612|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|1.9||||0.648|TWO_SIDED|95.0|-5.2|9.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||9.0|-5.2|0.648
73827613|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|9.1||||0.048|TWO_SIDED|95.0|-1.3|19.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||19.6|-1.3|0.048
73827614|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|11.2||||0.016|TWO_SIDED|95.0|1.8|20.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||20.6|1.8|0.016
73827615|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|8.6||||0.044|TWO_SIDED|95.0|0.4|16.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||16.9|0.4|0.044
73827616|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|3.6||||0.345|TWO_SIDED|95.0|-3.8|11.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||11.0|-3.8|0.345
73827617|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|2.6||||0.424|TWO_SIDED|95.0|-3.5|8.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||8.7|-3.5|0.424
73827618|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0||||0.527|TWO_SIDED|95.0|-9.4|5.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||5.5|-9.4|0.527
73827619|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|3.3||||0.584|TWO_SIDED|95.0|-6.7|13.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||13.4|-6.7|0.584
73827620|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|3.9||||0.519|TWO_SIDED|95.0|-6.5|14.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||14.3|-6.5|0.519
73827621|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Difference in percentage|-0.8||||0.766|TWO_SIDED|95.0|-10.1|8.5||The P-values are based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||8.5|-10.1|0.766
73827622|NCT02557399|147201910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.666|TWO_SIDED|95.0|-5.8|10.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||10.5|-5.8|0.666
73827623|NCT02557399|147201914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.017|TWO_SIDED|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.04|-0.40|0.017
73827624|NCT02557399|147201914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.017|TWO_SIDED|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.04|-0.40|0.017
73827625|NCT02557399|147201914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.024|TWO_SIDED|95.0|-0.41|-0.03|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.03|-0.41|0.024
73827626|NCT02557399|147201914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.08|TWO_SIDED|95.0|-0.36|0.02|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.02|-0.36|0.080
73827627|NCT00931632|147201918|SUPERIORITY_OR_OTHER|||||||0.427|TWO_SIDED||||||Mantel Haenszel|||||||0.427
73827628|NCT01687218|147201929|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.88|TWO_SIDED|95.0|0.73|1.44|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the Daily Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.||1.44|0.73|0.88
73827629|NCT01687218|147201929|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.43|TWO_SIDED|95.0|0.64|1.21|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the RAI Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.||1.21|0.64|0.43
73827630|NCT01687218|147201930|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.15|0.5|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.50|0.15|<0.0001
73827631|NCT01687218|147201930|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.37||||0.002|TWO_SIDED|95.0|0.2|0.7|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.70|0.20|0.002
73827632|NCT01687218|147201931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.56||||0.08|TWO_SIDED|95.0|0.29|1.08|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.08|0.29|0.08
73827633|NCT01687218|147201931|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.46|TWO_SIDED|95.0|0.37|1.56|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.56|0.37|0.46
73827634|NCT01687218|147201932|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.38||||0.0004|TWO_SIDED|95.0|0.22|0.65|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.65|0.22|0.0004
73827635|NCT01687218|147201932|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7||||0.23|TWO_SIDED|95.0|0.39|1.25|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.25|0.39|0.23
73827636|NCT01687218|147201933|OTHER||Slope|-1.41|||<|0.001|TWO_SIDED|95.0|-1.53|-1.3|||Mixed Models Analysis||This comparison is between the daily rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-1.30|-1.53|<0.001
73827637|NCT01687218|147201933|OTHER||Slope|-1.82|||<|0.001|TWO_SIDED|95.0|-1.95|-1.7|||Mixed Models Analysis||This comparison is between the RAI rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-1.70|-1.95|<0.001
73827638|NCT01687218|147201934|SUPERIORITY||Slope|0.66|||<|0.001|TWO_SIDED|95.0|0.49|0.83|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.83|0.49|<0.001
73827639|NCT01687218|147201934|SUPERIORITY||Slope|-0.16||||0.31|TWO_SIDED|95.0|-0.46|0.15|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.15|-0.46|0.31
73827640|NCT01687218|147201935|SUPERIORITY||Slope|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only were used in this analysis.||0.50|0.10|0.004
73827641|NCT01687218|147201935|SUPERIORITY||Slope|-0.7|||<|0.001|TWO_SIDED|95.0|-0.92|-0.47|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-0.47|-0.92|<0.001
73827642|NCT01687218|147201936|SUPERIORITY||Slope|-2.66|||<|0.001|TWO_SIDED|95.0|-2.82|-2.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.||-2.50|-2.82|<0.001
73827643|NCT01687218|147201936|SUPERIORITY||Slope|-2.65|||<|0.001|TWO_SIDED|95.0|-2.81|-2.49|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.||-2.49|-2.81|<0.001
73827644|NCT01687218|147201937|SUPERIORITY||Slope|-0.91|||<|0.001|TWO_SIDED|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.||-0.80|-1.01|<0.001
73827645|NCT01687218|147201937|SUPERIORITY||Slope|-0.91|||<|0.001|TWO_SIDED|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.||-0.80|-1.01|<0.001
73827646|NCT01687218|147201938|SUPERIORITY||Slope|-2.0|||<|0.001|TWO_SIDED|95.0|-2.16|-1.84|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.||-1.84|-2.16|<0.001
73827647|NCT01687218|147201938|SUPERIORITY||Slope|-1.9|||<|0.001|TWO_SIDED|95.0|-2.07|-1.74|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.||-1.74|-2.07|<0.001
73827648|NCT01687218|147201939|SUPERIORITY||Slope|0.54|||<|0.001|TWO_SIDED|95.0|0.35|0.72|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.72|0.35|<0.001
73827649|NCT01687218|147201939|SUPERIORITY||Slope|0.01||||0.92|TWO_SIDED|95.0|-0.28|0.31|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.31|-0.28|0.92
73827650|NCT01687218|147201940|SUPERIORITY||Odds Ratio (OR)|0.35||||0.0005|TWO_SIDED|95.0|0.19|0.63|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\<80% adherence versus\>80% adherence.||0.63|0.19|0.0005
73827651|NCT01687218|147201940|SUPERIORITY||Odds Ratio (OR)|0.89||||0.74|TWO_SIDED|95.0|0.43|1.81|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\<80% adherence versus\>80% adherence.||1.81|0.43|0.74
73827652|NCT01257347|147201973|SUPERIORITY_OR_OTHER||||||<=|0.001||||||We included a stopping rule in which recruitment would be stopped at the midpoint for futility if the z-score was negative or for efficacy if the z-score was positive and the p-value ≤ 0.001.|GEE model|GEE models (logit link) with clinician as the cluster variable, appropriateness of management as outcome, intervention group as explanatory variable.||The sample size was calculated to have sufficient power to detect meaningful differences in appropriateness of clinician management between intervention and control groups. Each patient-clinician encounter was treated as independent and the sample size was inflated to account for the design effect (DE) of clustering of patients within clinician. GEE stands for generalized estimating equation.||||<=0.001
73827653|NCT03204643|147201977|SUPERIORITY||Odds Ratio (OR)|0.74||||0.06|TWO_SIDED|95.0|0.54|1.02|||Regression, Logistic|||||1.02|0.54|0.06
73827654|NCT03204643|147201978|SUPERIORITY||Odds Ratio (OR)|1.07||||0.76|TWO_SIDED|95.0|0.7|1.64|||Mixed Models Analysis|||||1.64|0.70|0.76
73827655|NCT03204643|147201979|SUPERIORITY||Odds Ratio (OR)|1.16||||0.62|TWO_SIDED|95.0|0.65|2.08|||Mixed Models Analysis|||||2.08|0.65|0.62
73827656|NCT03204643|147201980|SUPERIORITY||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|0.96|0.96|1.9|||Mixed Models Analysis|||||1.90|0.96|0.08
73827657|NCT04356937|147202048|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.64|TWO_SIDED|95.0|0.38|1.81|||Log Rank|||||1.81|0.38|0.64
73827658|NCT04356937|147202049|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.73|TWO_SIDED|95.0|0.59|2.1|||Log Rank|||||2.10|0.59|0.73
73827659|NCT04356937|147202050|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.69|TWO_SIDED|95.0|0.67|1.3|||Log Rank|||||1.30|0.67|0.69
73827660|NCT03533751|147202057|SUPERIORITY||Least Squares (LS) Mean Difference|7.75|STANDARD_ERROR_OF_MEAN|10.235||0.4498|TWO_SIDED|95.0|-12.4066|27.8983|||ANCOVA|The p-value was obtained using a mixed effect analysis of covariance (ANCOVA) model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||27.8983|-12.4066|0.4498
73827661|NCT03533751|147202057|SUPERIORITY||LS Mean Difference|-6.32|STANDARD_ERROR_OF_MEAN|9.39||0.501|TWO_SIDED|95.0|-24.774|12.1262|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||12.1262|-24.7740|0.5010
73827662|NCT03533751|147202057|SUPERIORITY||LS Mean Difference|1.97|STANDARD_ERROR_OF_MEAN|9.454||0.8349|TWO_SIDED|95.0|-16.6037|20.5476|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||20.5476|-16.6037|0.8349
73827663|NCT03533751|147202057|SUPERIORITY||LS Mean Difference|4.82|STANDARD_ERROR_OF_MEAN|11.154||0.6662|TWO_SIDED|95.0|-17.1892|26.8275|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||26.8275|-17.1892|0.6662
73827664|NCT03533751|147202058|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7992|TWO_SIDED|95.0|0.42|1.9509|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||1.9509|0.4200|0.7992
73827665|NCT03533751|147202058|SUPERIORITY||Odds Ratio (OR)|1.59||||0.2197|TWO_SIDED|95.0|0.757|3.3572|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.3572|0.7570|0.2197
73827666|NCT03533751|147202058|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7197|TWO_SIDED|95.0|0.5345|2.4774|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||2.4774|0.5345|0.7197
73827667|NCT03533751|147202058|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6772|TWO_SIDED|95.0|0.391|1.8404|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||1.8404|0.3910|0.6772
73827668|NCT03533751|147202059|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9537|TWO_SIDED|95.0|0.3922|2.6994|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||2.6994|0.3922|0.9537
73827669|NCT03533751|147202059|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3316|TWO_SIDED|95.0|0.6323|3.8895|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.8895|0.6323|0.3316
73827670|NCT03533751|147202059|SUPERIORITY||Odds Ratio (OR)|1.36||||0.5166|TWO_SIDED|95.0|0.5331|3.4944|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.4944|0.5331|0.5166
73827671|NCT03533751|147202059|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7426|TWO_SIDED|95.0|0.4545|3.0223|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.0223|0.4545|0.7426
73827672|NCT03533751|147202060|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4543|TWO_SIDED|95.0|0.3998|7.7615|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||7.7615|0.3998|0.4543
73827673|NCT03533751|147202060|SUPERIORITY||Odds Ratio (OR)|2.57||||0.1874|TWO_SIDED|95.0|0.6314|10.4827|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||10.4827|0.6314|0.1874
73827674|NCT03533751|147202060|SUPERIORITY||Odds Ratio (OR)|2.69||||0.1721|TWO_SIDED|95.0|0.6506|11.0814|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||11.0814|0.6506|0.1721
73827675|NCT03533751|147202060|SUPERIORITY||Odds Ratio (OR)|0.68||||0.6755|TWO_SIDED|95.0|0.1086|4.2141|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||4.2141|0.1086|0.6755
73827676|NCT03533751|147202061|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6058|TWO_SIDED|95.0|0.2481|2.2543|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||2.2543|0.2481|0.6058
73827677|NCT03533751|147202061|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9521|TWO_SIDED|95.0|0.3356|2.7923|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||2.7923|0.3356|0.9521
73827678|NCT03533751|147202061|SUPERIORITY||Odds Ratio (OR)|1.23||||0.6905|TWO_SIDED|95.0|0.4457|3.3878|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||3.3878|0.4457|0.6905
73827679|NCT03533751|147202061|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9399|TWO_SIDED|95.0|0.3671|2.9518|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||2.9518|0.3671|0.9399
73827680|NCT03533751|147202062|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7659|TWO_SIDED|95.0|0.329|4.5268|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as covariate.||||4.5268|0.3290|0.7659
73827681|NCT03533751|147202062|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6273|TWO_SIDED|95.0|0.3895|4.776|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||4.7760|0.3895|0.6273
73827682|NCT03533751|147202062|SUPERIORITY||Odds Ratio (OR)|1.88||||0.2967|TWO_SIDED|95.0|0.5734|6.1879|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||6.1879|0.5734|0.2967
73827683|NCT03533751|147202062|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5544|TWO_SIDED|95.0|0.4152|5.1476|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||5.1476|0.4152|0.5544
73827684|NCT03533751|147202063|SUPERIORITY||Odds Ratio (OR)|1.12||||0.86|TWO_SIDED|95.0|0.3175|3.9513|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||3.9513|0.3175|0.8600
73827685|NCT03533751|147202063|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3222|TWO_SIDED|95.0|0.5511|6.1214|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.1214|0.5511|0.3222
73827686|NCT03533751|147202063|SUPERIORITY||Odds Ratio (OR)|1.98||||0.2564|TWO_SIDED|95.0|0.6089|6.431|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.4310|0.6089|0.2564
73827687|NCT03533751|147202063|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2912|TWO_SIDED|95.0|0.5806|6.1275|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.1275|0.5806|0.2912
73827688|NCT03533751|147202064|SUPERIORITY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|8.679||0.8927|TWO_SIDED|95.0|-18.2117|15.8686|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||15.8686|-18.2117|0.8927
73827689|NCT03533751|147202064|SUPERIORITY||LS Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|9.019||0.7035|TWO_SIDED|95.0|-14.2767|21.1463|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||21.1463|-14.2767|0.7035
73827690|NCT03533751|147202064|SUPERIORITY||LS Mean Difference|-9.27|STANDARD_ERROR_OF_MEAN|8.608||0.2819|TWO_SIDED|95.0|-26.159|7.6237|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||7.6237|-26.1590|0.2819
73827691|NCT03533751|147202064|SUPERIORITY||LS Mean Difference|-6.06|STANDARD_ERROR_OF_MEAN|8.557||0.4793|TWO_SIDED|95.0|-22.8452|10.7333|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||10.7333|-22.8452|0.4793
73827692|NCT03533751|147202065|SUPERIORITY||LS Mean Difference|6.57|STANDARD_ERROR_OF_MEAN|6.677||0.3262|TWO_SIDED|95.0|-6.5723|19.7054|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||19.7054|-6.5723|0.3262
73827693|NCT03533751|147202065|SUPERIORITY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|6.366||0.8465|TWO_SIDED|95.0|-13.7439|11.2782|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||11.2782|-13.7439|0.8465
73827694|NCT03533751|147202065|SUPERIORITY||LS Mean Difference|2.51|STANDARD_ERROR_OF_MEAN|6.396||0.6947|TWO_SIDED|95.0|-10.0587|15.082|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.||||15.0820|-10.0587|0.6947
73827695|NCT03533751|147202065|SUPERIORITY||LS Mean Difference|6.76|STANDARD_ERROR_OF_MEAN|6.909||0.3288|TWO_SIDED|95.0|-6.8451|20.3626|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||20.3626|-6.8451|0.3288
73827696|NCT03533751|147202066|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|1.355||0.8497|TWO_SIDED|95.0|-2.4081|2.9218|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||2.9218|-2.4081|0.8497
73827697|NCT03533751|147202066|SUPERIORITY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|1.35||0.5016|TWO_SIDED|95.0|-3.5636|1.7473|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||1.7473|-3.5636|0.5016
73827698|NCT03533751|147202066|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.386||0.7511|TWO_SIDED|95.0|-3.167|2.287|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||2.2870|-3.1670|0.7511
73827699|NCT03533751|147202066|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|1.396||0.7558|TWO_SIDED|95.0|-2.3133|3.1824|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||3.1824|-2.3133|0.7558
73827700|NCT01419535|147202070|SUPERIORITY|||||||0.6|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.60
73827701|NCT01419535|147202071|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
73827702|NCT01419535|147202072|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
73827703|NCT01419535|147202073|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
73827704|NCT01419535|147202074|SUPERIORITY|||||||0.004|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.004
73827705|NCT01419535|147202075|SUPERIORITY|||||||0.002|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.002
73827706|NCT02873689|147202081|SUPERIORITY|||||||0.057|||||||Wilcoxon rank-sum test|||||||0.057
73827707|NCT02873689|147202082|SUPERIORITY|||||||0.268|||||||Wilcoxon rank-sum test|||||||0.268
73827708|NCT00720278|147202100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_DEVIATION|0.47|<|0.001||95.0|-2.98|-1.14|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.14|-2.98|<0.001
73827709|NCT00720278|147202100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|0.465|<|0.001||95.0|-3.91|-2.09|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-2.09|-3.91|<0.001
73827710|NCT00720278|147202101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_DEVIATION|0.479|<|0.001||95.0|-2.72|-0.84|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-0.84|-2.72|<0.001
73827711|NCT00720278|147202101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.668|STANDARD_DEVIATION|0.4735|<|0.001||95.0|-3.6|-1.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.74|-3.60|<0.001
73827712|NCT00720278|147202102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.376|STANDARD_DEVIATION|0.418||0.001||95.0|-2.2|-0.56|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-0.56|-2.20|0.001
73827713|NCT00720278|147202102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.432|STANDARD_DEVIATION|0.4145|<|0.001||95.0|-3.24|-1.62|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.62|-3.24|<0.001
73827714|NCT00368251|147202112|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.15|||=|0.942|TWO_SIDED|95.0|-26.12|24.96||All hypotheses are tested at the 5 % level. The multiplicity scheme (hierarchical testing procedure) assures strong control of the type I error at the 5 % level.|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo was calculated.|"The first hypothesis for the primary efficacy variable compares placebo versus Brivaracetam (BRV) 150 mg/day.~The second hypothesis for the primary efficacy variable compares placebo versus BRV 5 mg/day. However, this second hypothesis will only be tested when all the hypotheses for placebo versus BRV 150 mg/day are significant for the primary three UMRS related secondary endpoints.~The hypotheses will be tested using nonparametric analysis. The study was designed to have 80 % power."||24.96|-26.12|=0.942
73827715|NCT00368251|147202112|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|-18.05|||=|0.105|TWO_SIDED|95.0|-39.31|4.86||Tested at the 5 % level - given the primary endpoint and the three UMRS related secondary endpoints comparing placebo versus Brivaracetam (BRV) 150 mg/day are significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||4.86|-39.31|=0.105
73827716|NCT00368251|147202113|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|1.24|||=|0.672|TWO_SIDED|95.0|-21.9|31.06||Tested at the 5 % level - given the Primary Outcome testing Placebo versus BRV 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann(unstratified).|Difference versus Placebo.|If primary efficacy is proven for Brivaracetam (BRV) 150 mg/day, the following secondary endpoints will be tested for Placebo versus BRV 150 mg/day. The testing scheme will be hierarchical, thus statistical significance at 5 % on BRV 150 mg/day on a secondary endpoint is needed to continue testing BRV 150 mg/day at 5 % significance level for the next secondary endpoint.||31.06|-21.90|=0.672
73827717|NCT00368251|147202113|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.806|TWO_SIDED|95.0|-33.33|18.75||Tested at the 5 % level - given the primary endpoint testing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intevals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|"In case the three endpoints are significant for placebo versus Brivaracetam (BRV) 150 mg/day, the primary endpoint will be tested for Placebo versus BRV 5 mg/day. In case of significance, the three UMRS related secondary endpoints will be tested for Placebo versus BRV 5 mg/day, provided the previous is significant at 5 %. Secondary endpoints are tested in the following order:~* Functional Disability~* Stimulus Sensitivity~* Myoclonus Patient Questionnaire"||18.75|-33.33|=0.806
73827718|NCT00368251|147202114|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.549|TWO_SIDED|95.0|-25.0|100.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Willcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||100.00|-25.00|=0.549
73827719|NCT00368251|147202114|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.654|TWO_SIDED|95.0|-50.0|66.67||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||66.67|-50.00|=0.654
73827720|NCT00368251|147202115|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|14.29|||=|0.037|TWO_SIDED|95.0|-1.76|39.39||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||39.39|-1.76|=0.037
73827721|NCT00368251|147202115|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|10.0|||=|0.111|TWO_SIDED|95.0|-5.56|30.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||30.00|-5.56|=0.111
73827722|NCT00368251|147202116|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.931||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test|||||||=0.931
73827723|NCT00368251|147202116|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.253||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test|||P-value for pairwise comparison of each Brivaracetam dose versus Placebo.||||=0.253
73827724|NCT03312738|147202117|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|90.0|0.4|0.71||||||||0.71|0.40|
73827725|NCT03312738|147202118|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|90.0|0.32|0.67||||||||0.67|0.32|
73827726|NCT03312738|147202119|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|90.0|0.69|1.89||||||||1.89|0.69|
73827727|NCT00607893|147202147|OTHER||Mean Difference (Final Values)|0.071||||0.38|TWO_SIDED|95.0|-0.09|0.23|||Regression, Linear||F2-isoprostanes/Cr was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.|||0.23|-0.090|0.38
73827728|NCT00607893|147202148|OTHER||Mean Difference (Final Values)|1.83||||0.85|TWO_SIDED|95.0|-17.42|21.07|||Regression, Linear|||||21.07|-17.42|0.85
73827729|NCT00607893|147202149|OTHER||Mean Difference (Final Values)|0.14||||0.92|TWO_SIDED|95.0|-2.6|2.87|||Regression, Linear|||||2.87|-2.60|0.92
73827730|NCT00607893|147202150|OTHER||Mean Difference (Final Values)|0.21||||0.55|TWO_SIDED|95.0|-0.48|0.91|||Regression, Linear|||||0.91|-0.48|0.55
73827731|NCT00607893|147202151|OTHER||Mean Difference (Final Values)|0.38||||0.17|TWO_SIDED|95.0|-0.16|0.92|||Regression, Linear|||||0.92|-0.16|0.17
73827732|NCT00607893|147202152|OTHER||Mean Difference (Final Values)|2.4||||0.076|TWO_SIDED|95.0|-0.26|5.07|||Regression, Linear|||||5.07|-0.26|0.076
73827733|NCT00607893|147202153|OTHER||Mean Difference (Final Values)|0.062||||0.019|TWO_SIDED|95.0|0.01|0.11|||Regression, Linear||sIL-6R was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.|||0.11|0.010|0.019
73827734|NCT00607893|147202154|OTHER||Mean Difference (Final Values)|0.17||||0.68|TWO_SIDED|95.0|-0.64|0.99|||Regression, Linear|||||0.99|-0.64|0.68
73827735|NCT00607893|147202155|OTHER||Mean Difference (Final Values)|1.35||||0.59|TWO_SIDED|95.0|-3.6|6.31|||Regression, Linear|||||6.31|-3.60|0.59
73827736|NCT00607893|147202156|OTHER||Mean Difference (Final Values)|6.93|||<|0.001|TWO_SIDED|95.0|3.04|10.81|||Regression, Linear|||||10.81|3.04|<0.001
73827737|NCT02669849|147202157|SUPERIORITY||Least Squares (LS) Mean Difference|-0.69||||0.7519|TWO_SIDED|95.0|-5.08|3.69|||Mixed-effects model for repeated measure|||||3.69|-5.08|0.7519
73827738|NCT01248416|147202178|SUPERIORITY||||||<|0.006|||||||ANCOVA|||||||<0.006
73827739|NCT01248416|147202180|SUPERIORITY|||||||0.906|||||||ANOVA|||||||0.906
73827740|NCT01248416|147202181|SUPERIORITY|||||||0.015|||||||ANOVA|||||||0.015
73827741|NCT01248416|147202183|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73827742|NCT01248416|147202184|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
73827743|NCT01248416|147202185|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
73827744|NCT02014272|147202187|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.45|||||TWO_SIDED|90.0|92.07|98.94||||||Natural log transformed AUClast of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||98.94|92.07|
73827745|NCT02014272|147202187|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|103.45|||||TWO_SIDED|90.0|99.33|107.75||||||Natural log transformed AUClast of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||107.75|99.33|
73827746|NCT02014272|147202188|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.63|||||TWO_SIDED|90.0|83.13|101.01||||||Natural log transformed Cmax of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||101.01|83.13|
73827747|NCT02014272|147202188|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|107.58|||||TWO_SIDED|90.0|96.07|120.47||||||Natural log transformed Cmax of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||120.47|96.07|
73827748|NCT02014272|147202189|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.92|||||TWO_SIDED|90.0|92.54|99.43||||||Natural log transformed AUC(0 - ∞) of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||99.43|92.54|
73827749|NCT02014272|147202189|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|102.41|||||TWO_SIDED|90.0|98.76|106.19||||||Natural log transformed AUC(0 - ∞) of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||106.19|98.76|
73827750|NCT03499795|147202194|SUPERIORITY|||||||0.8633|||||||Clopper-Pearson|P-value was calculated based on the exact method of Clopper-Pearson and superiority was concluded if the one-sided p-value is \<0.05.||||||0.8633
73827751|NCT02741284|147202209|NON_INFERIORITY|A noninferiority margin of 30% (mean difference \<1.0 mmol/l) was pre-specified as it corresponds to an upper umbilical artery lactate cut-off value of 4.5 mmol/L, above which there is an increased risk of neonatal morbidity|Mean Difference (Final Values)|0.1||||0.69|TWO_SIDED|95.0|-0.5|0.7|||Wilcoxon (Mann-Whitney)|||||0.7|-0.5|0.69
73827752|NCT02741284|147202210|NON_INFERIORITY|Noninferiority margin 30%|Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED|95.0|-0.01|0.03|||t-test, 2 sided|||pH||0.03|-0.01|<0.05
73827753|NCT02741284|147202211|SUPERIORITY||Risk Ratio (RR)|0.32|||<|0.05|TWO_SIDED|95.0|0.07|1.48|||Chi-squared|||Cesarean delivery||1.48|0.07|<0.05
73827754|NCT02741284|147202211|SUPERIORITY||Risk Ratio (RR)|0.0|||<|0.05|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Cesarean delivery for non reassuring fetal status||0|0|<0.05
73827755|NCT02741284|147202211|SUPERIORITY||Risk Ratio (RR)|5.65|||<|0.05|TWO_SIDED|95.0|0.71|45.2|||Chi-squared|||Operative vaginal delivery||45.20|0.71|<0.05
73827756|NCT02741284|147202212|SUPERIORITY||Mean Difference (Net)|-1.5||||0.44|TWO_SIDED|95.0|-5.4|2.4|||t-test, 2 sided|||||2.4|-5.4|0.44
73827757|NCT02741284|147202213|SUPERIORITY||Mean Difference (Net)|-4.7||||0.06|TWO_SIDED|95.0|-9.6|0.1|||t-test, 2 sided|||||0.1|-9.6|0.06
73827758|NCT02741284|147202214|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||||1.0|-1.0|0.99
73827759|NCT01516216|147202250|SUPERIORITY|||||||0.07|||||||Log Rank|||||||0.07
73827760|NCT01516216|147202251|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
73827761|NCT01516216|147202252|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
73827762|NCT01516216|147202254|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
73827763|NCT01516216|147202257|SUPERIORITY|||||||0.9801|||||||Chi-squared|||||||0.9801
73827764|NCT01516216|147202258|SUPERIORITY|||||||0.7444|||||||Chi-squared|||||||0.7444
73827765|NCT01603602|147202298|SUPERIORITY||Least Squares (LS) Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.938|-0.379||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|Mixed Model Repeated Measures (MMRM)|||||-0.379|-0.938|<0.001
73827766|NCT01603602|147202298|SUPERIORITY||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.992|-0.426||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||-0.426|-0.992|<0.001
73827767|NCT01603602|147202299|SUPERIORITY||LS Mean Difference|0.21||||0.155|TWO_SIDED|95.0|-0.082|0.511||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||0.511|-0.082|0.155
73827768|NCT01603602|147202299|SUPERIORITY||LS Mean Difference|0.22||||0.147|TWO_SIDED|95.0|-0.079|0.523||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||0.523|-0.079|0.147
73827769|NCT01603602|147202300|SUPERIORITY||LS Mean Difference|-0.39||||0.111|TWO_SIDED|95.0|-0.861|0.091||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||||0.091|-0.861|0.111
73827770|NCT01603602|147202300|SUPERIORITY||LS Mean Difference|-0.44||||0.078|TWO_SIDED|95.0|-0.933|0.051||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||||0.051|-0.933|0.078
73827771|NCT01603602|147202301|SUPERIORITY||LS Mean Difference|-0.1||||0.636|TWO_SIDED|95.0|-0.498|0.305||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.305|-0.498|0.636
73827772|NCT01603602|147202301|SUPERIORITY||LS Mean Difference|-0.09||||0.658|TWO_SIDED|95.0|-0.502|0.318||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.318|-0.502|0.658
73827773|NCT01603602|147202301|SUPERIORITY||LS Mean Difference|0.24||||0.243|TWO_SIDED|95.0|-0.162|0.635||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.635|-0.162|0.243
73827774|NCT01603602|147202301|SUPERIORITY||LS Mean Difference|0.17||||0.412|TWO_SIDED|95.0|-0.237|0.576||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.576|-0.237|0.412
73827775|NCT01603602|147202301|SUPERIORITY||LS Mean Difference|-0.02||||0.904|TWO_SIDED|95.0|-0.408|0.361||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.361|-0.408|0.904
73827776|NCT01603602|147202301|SUPERIORITY||LS Mean Difference|-0.25||||0.2|TWO_SIDED|95.0|-0.641|0.135||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.135|-0.641|0.200
73827777|NCT01603602|147202301|SUPERIORITY||LS Mean Difference|0.59||||0.003|TWO_SIDED|95.0|0.21|0.978||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.978|0.210|0.003
73827778|NCT01603602|147202301|SUPERIORITY||LS Mean Difference|0.19||||0.327|TWO_SIDED|95.0|-0.194|0.58||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.580|-0.194|0.327
73827779|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|12.1||||0.117|TWO_SIDED|95.0|-3.089|27.293||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow||27.293|-3.089|0.117
73827780|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|8.41||||0.273|TWO_SIDED|95.0|-6.717|23.527||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow||23.527|-6.717|0.273
73827781|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|14.71||||0.015|TWO_SIDED|95.0|2.958|26.458||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow||26.458|2.958|0.015
73827782|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|11.85||||0.046|TWO_SIDED|95.0|0.203|23.504||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow||23.504|0.203|0.046
73827783|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|20.97|||<|0.001|TWO_SIDED|95.0|8.801|33.137||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow||33.137|8.801|<0.001
73827784|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|11.35||||0.064|TWO_SIDED|95.0|-0.662|23.362||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow||23.362|-0.662|0.064
73827785|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|15.25||||0.013|TWO_SIDED|95.0|3.317|27.178||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow||27.178|3.317|0.013
73827786|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|7.22||||0.225|TWO_SIDED|95.0|-4.488|18.934||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow||18.934|-4.488|0.225
73827787|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|4.5||||0.409|TWO_SIDED|95.0|-6.239|15.236||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow||15.236|-6.239|0.409
73827788|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|3.86||||0.47|TWO_SIDED|95.0|-6.69|14.419||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow||14.419|-6.690|0.470
73827789|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|-6.13||||0.263|TWO_SIDED|95.0|-16.962|4.706||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist||4.706|-16.962|0.263
73827790|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|-14.6||||0.012|TWO_SIDED|95.0|-25.846|-3.36||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist||-3.360|-25.846|0.012
73827791|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|-10.64||||0.098|TWO_SIDED|95.0|-23.277|1.996||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist||1.996|-23.277|0.098
73827792|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|-13.1||||0.051|TWO_SIDED|95.0|-26.26|0.068||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist||0.068|-26.260|0.051
73827793|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|-17.11||||0.01|TWO_SIDED|95.0|-30.031|-4.189||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist||-4.189|-30.031|0.010
73827794|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|-11.25||||0.098|TWO_SIDED|95.0|-24.622|2.131||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist||2.131|-24.622|0.098
73827795|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|-17.71||||0.005|TWO_SIDED|95.0|-29.888|-5.537||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist||-5.537|-29.888|0.005
73827796|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|-15.74||||0.015|TWO_SIDED|95.0|-28.293|-3.194||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist||-3.194|-28.293|0.015
73827797|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|-15.25||||0.02|TWO_SIDED|95.0|-28.01|-2.492||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist||-2.492|-28.010|0.020
73827798|NCT01603602|147202302|SUPERIORITY||LS Mean Difference|-13.52||||0.046|TWO_SIDED|95.0|-26.797|-0.243||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist||-0.243|-26.797|0.046
73827799|NCT01079780|147202303|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|||||||||||||
73827800|NCT01079780|147202304|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
73827801|NCT01079780|147202306|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.55|TWO_SIDED||||||Log Rank|||||||0.55
73827802|NCT03176771|147202345|SUPERIORITY||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.5|-2.6|||Mixed-effect Model Repeated Measures|||"Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:~* AIMS dyskinesia total score mean change from baseline (CFB): MT-5199 80 mg vs. placebo.~* AIMS: MT-5199 40 mg vs. PBO. For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance."||-2.6|-4.5|<0.001
73827803|NCT03176771|147202345|SUPERIORITY||Median Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.3|||Mixed-effect Model Repeated Measures|||||-1.3|-3.0|<0.001
73827804|NCT03176771|147202346|SUPERIORITY||Risk Difference (RD)|13.6||||0.027|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.027
73827805|NCT03176771|147202346|SUPERIORITY||Risk Difference (RD)|36.9|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
73827806|NCT03176771|147202347|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.013|TWO_SIDED|95.0|-2.7|-0.3|||Mixed-effect Model Repeated Measures|||||-0.3|-2.7|0.013
73827807|NCT03176771|147202347|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.5|-1.1|||Mixed-effect Model Repeated Measures|||||-1.1|-3.5|<0.001
73827808|NCT03176771|147202348|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.021|TWO_SIDED|95.0|-0.7|-0.1|||ANOVA|||||-0.1|-0.7|0.021
73827809|NCT03176771|147202348|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||ANOVA|||||-0.3|-1.0|<0.001
73827810|NCT02265510|147202367|OTHER|Descriptive Statistics|||||||||||||||||The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
73827811|NCT02265510|147202368|OTHER||||||||||||||||||Confidence Intervals for ORR were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.|||
73827812|NCT02265510|147202369|OTHER||||||||||||||||||Confidence Intervals for response were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.|||
73827813|NCT02265510|147202370|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
73827814|NCT02265510|147202371|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
73827815|NCT02265510|147202372|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
73827816|NCT02265510|147202373|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
73827817|NCT02265510|147202374|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
73827818|NCT02265510|147202375|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
73827819|NCT02265510|147202376|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
73827820|NCT02265510|147202377|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
73827821|NCT01668797|147202390|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.||The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 1:1 (brexpiprazole:placebo) randomization ratio.||||<0.0001
73827822|NCT01668797|147202391|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||The percentage of participants with impending relapse in treatment groups (Brexpiprazole and placebo) in final analysis for participants meeting at least one of the criteria.||||<0.0001
73827823|NCT01668797|147202392|SUPERIORITY_OR_OTHER|||||||0.2296|||||||Chi-squared|||Statistical analysis at Week 6.||||0.2296
73827824|NCT01668797|147202392|SUPERIORITY_OR_OTHER|||||||0.2051|||||||Chi-squared|||Statistical analysis at Week 12.||||0.2051
73827825|NCT01668797|147202392|SUPERIORITY_OR_OTHER|||||||0.7354|||||||Chi-squared|||Statistical analysis at Week 24.||||0.7354
73827826|NCT01668797|147202392|SUPERIORITY_OR_OTHER|||||||0.1977|||||||Chi-squared|||Statistical analysis at Week 36.||||0.1977
73827827|NCT01668797|147202392|SUPERIORITY_OR_OTHER|||||||0.8734|||||||Chi-squared|||Statistical analysis at Week 52.||||0.8734
73827828|NCT01668797|147202392|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Chi-squared|||Statistical analysis at Last Visit.||||0.0007
73827829|NCT01668797|147202393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.0664|TWO_SIDED|95.0|-6.82|0.23|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 6.||0.23|-6.82|0.0664
73827830|NCT01668797|147202393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.31||||0.0301|TWO_SIDED|95.0|-10.1|-0.52|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 12.||-0.52|-10.1|0.0301
73827831|NCT01668797|147202393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.77||||0.0226|TWO_SIDED|95.0|-8.86|-0.68|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 24.||-0.68|-8.86|0.0226
73827832|NCT01668797|147202393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03||||0.0086|TWO_SIDED|95.0|-10.5|-1.59|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 36.||-1.59|-10.5|0.0086
73827833|NCT01668797|147202393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.31||||0.28|TWO_SIDED|95.0|-18.1|5.46|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 52.||5.46|-18.1|0.2800
73827834|NCT01668797|147202393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.42||||0.0011|TWO_SIDED|95.0|-7.01|-1.82|||Mixed Models Analysis|||Statistical analysis at across visits||-1.82|-7.01|0.0011
73827835|NCT01668797|147202394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.04||||0.0683|TWO_SIDED|95.0|-6.31|0.23|||ANCOVA|||Statistical analysis at Week 6.||0.23|-6.31|0.0683
73827836|NCT01668797|147202394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.05||||0.0174|TWO_SIDED|95.0|-9.2|-0.9|||ANCOVA|||Statistical analysis at Week 12.||-0.90|-9.20|0.0174
73827837|NCT01668797|147202394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59||||0.0008|TWO_SIDED|95.0|-12.0|-3.18|||ANCOVA|||Statistical analysis at Week 24.||-3.18|-12.0|0.0008
73827838|NCT01668797|147202394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.02||||0.0005|TWO_SIDED|95.0|-12.4|-3.59|||ANCOVA|||Statistical analysis at Week 36.||-3.59|-12.4|0.0005
73827839|NCT01668797|147202394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.95||||0.0007|TWO_SIDED|95.0|-12.5|-3.41|||ANCOVA|||Statistical analysis at Week 52.||-3.41|-12.5|0.0007
73827840|NCT01668797|147202395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.0507|TWO_SIDED|95.0|-2.23|0.0|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.00|-2.23|0.0507
73827841|NCT01668797|147202395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.008|TWO_SIDED|95.0|-3.24|-0.5|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.50|-3.24|0.0080
73827842|NCT01668797|147202395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.0215|TWO_SIDED|95.0|-2.89|-0.24|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.24|-2.89|0.0215
73827843|NCT01668797|147202395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.0053|TWO_SIDED|95.0|-3.19|-0.58|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.58|-3.19|0.0053
73827844|NCT01668797|147202395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.339|TWO_SIDED|95.0|-5.2|-0.22|||Mixed Models Analysis|||Statistical analysis at Week 52.||-0.22|-5.20|0.339
73827845|NCT01668797|147202395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.32|-0.88|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.88|-2.32|< 0.0001
73827846|NCT01668797|147202396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.1093|TWO_SIDED|95.0|-2.1|0.21|||ANCOVA|||Statistical analysis at Week 6.||0.21|-2.10|0.1093
73827847|NCT01668797|147202396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.0089|TWO_SIDED|95.0|-3.25|-0.47|||ANOVA|||Statistical analysis at Week 12.||-0.47|-3.25|0.0089
73827848|NCT01668797|147202396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.0005|TWO_SIDED|95.0|-4.26|-1.22|||ANCOVA|||Statistical analysis at Week 24.||-1.22|-4.26|0.0005
73827849|NCT01668797|147202396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.94||||0.0001|TWO_SIDED|95.0|-4.43|-1.44|||ANCOVA|||Statistical analysis at Week 36.||-1.44|-4.43|0.0001
73827850|NCT01668797|147202396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.18|||<|0.0001|TWO_SIDED|95.0|-4.7|-1.66|||ANCOVA|||Statistical analysis at Week 52||-1.66|-4.70|<0.0001
73827851|NCT01668797|147202397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.165|TWO_SIDED|95.0|-1.66|0.29|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.29|-1.66|0.1650
73827852|NCT01668797|147202397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.2001|TWO_SIDED|95.0|-1.97|0.42|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.42|-1.97|0.2001
73827853|NCT01668797|147202397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.0939|TWO_SIDED|95.0|-2.07|0.16|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.16|-2.07|0.0939
73827854|NCT01668797|147202397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.1396|TWO_SIDED|95.0|-2.44|0.35|||Mixed Models Analysis|||Statistical analysis at Week 36.||0.35|-2.44|0.1396
73827855|NCT01668797|147202397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.847|TWO_SIDED|95.0|-4.14|5.0|||Mixed Models Analysis|||Statistical analysis at Week 52.||5.00|-4.14|0.8470
73827856|NCT01668797|147202397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.2258|TWO_SIDED|95.0|-1.24|0.3|||Mixed Models Analysis|||Statistical analysis at across visits.||0.3|-1.24|0.2258
73827857|NCT01668797|147202398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0981|TWO_SIDED|95.0|-1.65|0.14|||ANCOVA|||Statistical analysis at Week 6.||0.14|-1.65|0.0981
73827858|NCT01668797|147202398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.0264|TWO_SIDED|95.0|-2.3|-0.15|||ANCOVA|||Statistical analysis at Week 12.||-0.15|-2.30|0.0264
73827859|NCT01668797|147202398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.0078|TWO_SIDED|95.0|-2.69|-0.42|||ANCOVA|||Statistical analysis at Week 24.||-0.42|-2.69|0.0078
73827860|NCT01668797|147202398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.0101|TWO_SIDED|95.0|-2.77|-0.38|||ANCOVA|||Statistical analysis at Week 36.||-0.38|-2.77|0.0101
73827861|NCT01668797|147202398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0516|TWO_SIDED|95.0|-2.5|0.01|||ANCOVA|||Statistical analysis at Week 52||0.01|-2.50|0.0516
73827862|NCT01668797|147202399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0279|TWO_SIDED|95.0|-0.53|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 6.||-0.03|-0.53|0.0279
73827863|NCT01668797|147202399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0117|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.09|-0.68|0.0117
73827864|NCT01668797|147202399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0105|TWO_SIDED|95.0|-0.64|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.09|-0.64|0.0105
73827865|NCT01668797|147202399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0007|TWO_SIDED|95.0|-0.87|-0.25|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.25|-0.87|0.0007
73827866|NCT01668797|147202399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.078|TWO_SIDED|95.0|-1.09|0.06|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.06|-1.09|0.0780
73827867|NCT01668797|147202399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0006|TWO_SIDED|95.0|-0.54|-0.15|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.15|-0.54|0.0006
73827868|NCT01668797|147202400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0284|TWO_SIDED|95.0|-0.47|-0.03|||ANCOVA|||Statistical analysis at Week 6.||-0.03|-0.47|0.0284
73827869|NCT01668797|147202400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0056|TWO_SIDED|95.0|-0.62|-0.11|||ANCOVA|||Statistical analysis at Week 12.||-0.11|-0.62|0.0056
73827870|NCT01668797|147202400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0002|TWO_SIDED|95.0|-0.76|-0.24|||ANCOVA|||Statistical analysis at Week 24.||-0.24|-0.76|0.0002
73827871|NCT01668797|147202400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.3|||ANCOVA|||Statistical analysis at Week 36.||-0.30|-0.82|<.0001
73827872|NCT01668797|147202400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0002|TWO_SIDED|95.0|-0.79|-0.26|||ANCOVA|||Statistical analysis at Week 52||-0.26|-0.79|0.0002
73827873|NCT01668797|147202401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0387|TWO_SIDED|95.0|-0.6|-0.2|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 6.||-0.20|-0.60|0.0387
73827874|NCT01668797|147202401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0185|TWO_SIDED|95.0|-0.75|-0.07|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 12.||-0.07|-0.75|0.0185
73827875|NCT01668797|147202401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.001|TWO_SIDED|95.0|-0.97|-0.24|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 24.||-0.24|-0.97|0.0010
73827876|NCT01668797|147202401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0004|TWO_SIDED|95.0|-1.02|-0.3|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 36.||-0.30|-1.02|0.0004
73827877|NCT01668797|147202401|SUPERIORITY_OR_OTHER||Treatment difference|-0.61||||0.0009|TWO_SIDED|95.0|-0.96|-0.25|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 52.||-0.25|-0.96|0.0009
73827878|NCT01668797|147202402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.6525|TWO_SIDED|95.0|-3.47|5.49|||Mixed Models Analysis|||Statistical analysis at Week 24.||5.49|-3.47|0.6525
73827879|NCT01668797|147202402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08||||0.1677|TWO_SIDED|95.0|-2.71|14.87|||Mixed Models Analysis|||Statistical analysis at Week 52.||14.87|-2.71|0.1677
73827880|NCT01668797|147202402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.55||||0.2347|TWO_SIDED|95.0|-2.41|9.5|||Mixed Models Analysis|||Statistical analysis at across visits.||9.5|-2.41|0.2347
73827881|NCT01668797|147202403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.79||||0.0285|TWO_SIDED|95.0|0.4|7.17|||ANCOVA|||Statistical analysis at Week 24.||7.17|0.40|0.0285
73827882|NCT01668797|147202403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75||||0.0071|TWO_SIDED|95.0|1.31|8.18|||ANCOVA|||Statistical analysis at Week 52.||8.18|1.31|0.0071
73827883|NCT01668797|147202404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61||||0.329|TWO_SIDED|95.0|-1.65|4.88|||Mixed Models Analysis|||Statistical analysis at Week 12.||4.88|-1.65|0.3290
73827884|NCT01668797|147202404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66||||0.1765|TWO_SIDED|95.0|-1.22|6.54|||Mixed Models Analysis|||Statistical analysis at Week 24.||6.54|-1.22|0.1765
73827885|NCT01668797|147202404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5||||0.0331|TWO_SIDED|95.0|0.38|8.63|||Mixed Models Analysis|||Statistical analysis at Week 36.||8.63|0.38|0.0331
73827886|NCT01668797|147202404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.88||||0.0522|TWO_SIDED|95.0|-0.06|11.82|||Mixed Models Analysis|||Statistical analysis at Week 52.||11.82|-0.06|0.0522
73827887|NCT01668797|147202404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66||||0.0281|TWO_SIDED|95.0|0.41|6.92|||Mixed Models Analysis|||Statistical analysis at across visits.||6.92|0.41|0.0281
73827888|NCT01668797|147202405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.88||||0.0111|TWO_SIDED|95.0|0.9|6.86|||ANCOVA|||Statistical analysis at Week 12.||6.86|0.90|0.0111
73827889|NCT01668797|147202405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.36||||0.0014|TWO_SIDED|95.0|2.1|8.62|||ANCOVA|||Statistical analysis at Week 24.||8.62|2.10|0.0014
73827890|NCT01668797|147202405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.81|||<|0.0001|TWO_SIDED|95.0|3.61|10.0|||ANCOVA|||Statistical analysis at Week 36.||10.00|3.61|<.0001
73827891|NCT01668797|147202405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.55||||0.0001|TWO_SIDED|95.0|3.28|9.83|||ANCOVA|||Statistical analysis at Week 52.||9.83|3.28|0.0001
73827892|NCT01668797|147202406|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Log Rank|||||||0.0014
73827893|NCT01668797|147202407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.1577|TWO_SIDED|95.0|-1.02|0.17|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.17|-1.02|0.1577
73827894|NCT01668797|147202407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.1685|TWO_SIDED|95.0|-1.61|0.28|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.28|-1.61|0.1685
73827895|NCT01668797|147202407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.2815|TWO_SIDED|95.0|-1.43|0.42|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.42|-1.43|0.2815
73827896|NCT01668797|147202407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.0286|TWO_SIDED|95.0|-2.16|-0.12|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.12|-2.16|0.0286
73827897|NCT01668797|147202407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.1803|TWO_SIDED|95.0|-2.58|0.51|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.51|-2.58|0.1803
73827898|NCT01668797|147202407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0077|TWO_SIDED|95.0|-1.12|-0.17|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.17|-1.12|0.0077
73827899|NCT01668797|147202408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1852|TWO_SIDED|95.0|-1.06|0.21|||ANCOVA|||Statistical analysis at Week 6.||0.21|-1.06|0.1852
73827900|NCT01668797|147202408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.143|TWO_SIDED|95.0|-1.47|0.21|||ANCOVA|||Statistical analysis at Week 12.||0.21|-1.47|0.1430
73827901|NCT01668797|147202408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0323|TWO_SIDED|95.0|-2.06|-0.09|||ANCOVA|||Statistical analysis at Week 24.||-0.09|-2.06|0.0323
73827902|NCT01668797|147202408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0071|TWO_SIDED|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis at Week 36.||-0.37|-2.31|0.0071
73827903|NCT01668797|147202408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.0023|TWO_SIDED|95.0|-2.52|-0.56|||ANCOVA|||Statistical analysis at Week 52.||-0.56|-2.52|0.0023
73827904|NCT01668797|147202409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0288|TWO_SIDED|95.0|-2.54|-0.14|||Mixed Models Analysis|||Statistical analysis at Week 6.||-0.14|-2.54|0.0288
73827905|NCT01668797|147202409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.0128|TWO_SIDED|95.0|-3.6|-0.44|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.44|-3.60|0.0128
73827906|NCT01668797|147202409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59||||0.0462|TWO_SIDED|95.0|-3.15|0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.03|-3.15|0.0462
73827907|NCT01668797|147202409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||0.0074|TWO_SIDED|95.0|-3.94|-0.64|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.64|-3.94|0.0074
73827908|NCT01668797|147202409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.0136|TWO_SIDED|95.0|-6.05|-0.75|||Mixed Models Analysis|||Statistical analysis at Week 52||-0.75|-6.05|0.0136
73827909|NCT01668797|147202409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91||||0.0001|TWO_SIDED|95.0|-2.84|-0.97|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.97|-2.84|0.0001
73827910|NCT01668797|147202410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0695|TWO_SIDED|95.0|-2.26|0.09|||ANCOVA|||Statistical analysis at Week 6.||0.09|-2.26|0.0695
73827911|NCT01668797|147202410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||0.0089|TWO_SIDED|95.0|-3.38|-0.49|||ANCOVA|||Statistical analysis at Week 12.||-0.49|-3.38|0.0089
73827912|NCT01668797|147202410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.83||||0.0004|TWO_SIDED|95.0|-4.39|-1.27|||ANCOVA|||Statistical analysis at Week 24.||-1.27|-4.39|0.0004
73827913|NCT01668797|147202410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09||||0.0001|TWO_SIDED|95.0|-4.63|-1.54|||ANCOVA|||Statistical analysis at Week 36.||-1.54|-4.63|0.0001
73827914|NCT01668797|147202410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|||<|0.0001|TWO_SIDED|95.0|-4.99|-1.89|||ANCOVA|||Statistical analysis at Week 52.||-1.89|-4.99|<0.0001
73827915|NCT01668797|147202411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.1969|TWO_SIDED|95.0|-1.66|0.35|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.35|-1.66|0.1969
73827916|NCT01668797|147202411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.2007|TWO_SIDED|95.0|-2.04|0.43|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.43|-2.04|0.2007
73827917|NCT01668797|147202411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0436|TWO_SIDED|95.0|-2.3|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.03|-2.30|0.0436
73827918|NCT01668797|147202411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.0444|TWO_SIDED|95.0|-2.97|-0.04|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.04|-2.97|0.0444
73827919|NCT01668797|147202411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.8927|TWO_SIDED|95.0|-4.4|5.02|||Mixed Models Analysis|||Statistical analysis at Week 52.||5.02|-4.40|0.8927
73827920|NCT01668797|147202411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.2154|TWO_SIDED|95.0|-1.34|0.31|||Mixed Models Analysis|||Statistical analysis at across visits.||0.31|-1.34|0.2154
73827921|NCT01668797|147202412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.0707|TWO_SIDED|95.0|-1.78|0.07|||ANCOVA|||Statistical analysis at Week 6.||0.07|-1.78|0.0707
73827922|NCT01668797|147202412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0276|TWO_SIDED|95.0|-2.35|-0.14|||ANCOVA|||Statistical analysis at Week 12.||-0.14|-2.35|0.0276
73827923|NCT01668797|147202412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59||||0.0065|TWO_SIDED|95.0|-2.72|-0.45|||ANCOVA|||Statistical analysis at Week 24.||-0.45|-2.72|0.0065
73827924|NCT01668797|147202412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0085|TWO_SIDED|95.0|-2.84|-0.42|||ANCOVA|||Statistical analysis at Week 36.||-0.42|-2.84|0.0085
73827925|NCT01668797|147202412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.063|TWO_SIDED|95.0|-2.52|0.07|||ANCOVA|||Statistical analysis at Week 52.||0.07|-2.52|0.0630
73827926|NCT01668797|147202413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.2251|TWO_SIDED|95.0|-1.33|0.31|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.31|-1.33|0.2251
73827927|NCT01668797|147202413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.0368|TWO_SIDED|95.0|-2.19|-0.07|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.07|-2.19|0.0368
73827928|NCT01668797|147202413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0024|TWO_SIDED|95.0|-2.51|-0.56|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.56|-2.51|0.0024
73827929|NCT01668797|147202413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48||||0.0293|TWO_SIDED|95.0|-2.8|-0.15|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.15|-2.80|0.0293
73827930|NCT01668797|147202413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.9632|TWO_SIDED|95.0|-3.32|3.17|||Mixed Models Analysis|||Statistical analysis at Week 52.||3.17|-3.32|0.9632
73827931|NCT01668797|147202413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.0029|TWO_SIDED|95.0|-1.63|-0.34|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.34|-1.63|0.0029
73827932|NCT01668797|147202414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.1062|TWO_SIDED|95.0|-1.44|0.14|||ANCOVA|||Statistical analysis at Week 6.||0.14|-1.44|0.1062
73827933|NCT01668797|147202414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||0.0051|TWO_SIDED|95.0|-2.33|-0.42|||ANCOVA|||Statistical analysis at Week 12.||-0.42|-2.33|0.0051
73827934|NCT01668797|147202414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.0001|TWO_SIDED|95.0|-3.08|-1.01|||ANCOVA|||Statistical analysis at Week 24.||-1.01|-3.08|0.0001
73827935|NCT01668797|147202414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||0.0004|TWO_SIDED|95.0|-3.0|-0.89|||ANCOVA|||Statistical analysis at Week 36.||-0.89|-3.00|0.0004
73827936|NCT01668797|147202414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69||||0.0035|TWO_SIDED|95.0|-2.81|-0.56|||ANCOVA|||Statistical analysis at Week 52.||-0.56|-2.81|0.0035
73827937|NCT01668797|147202415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.1465|TWO_SIDED|95.0|-0.85|0.13|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.13|-0.85|0.1465
73827938|NCT01668797|147202415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.2154|TWO_SIDED|95.0|-1.27|0.29|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.29|-1.27|0.2154
73827939|NCT01668797|147202415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.2696|TWO_SIDED|95.0|-1.23|0.35|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.35|-1.23|0.2696
73827940|NCT01668797|147202415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.0179|TWO_SIDED|95.0|-1.95|-0.19|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.19|-1.95|0.0179
73827941|NCT01668797|147202415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.0875|TWO_SIDED|95.0|-2.46|0.18|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.18|-2.46|0.0875
73827942|NCT01668797|147202415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0021|TWO_SIDED|95.0|-1.08|-0.24|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.24|-1.08|0.0021
73827943|NCT01668797|147202416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2135|TWO_SIDED|95.0|-0.86|0.19|||ANCOVA|||Statistical analysis at Week 6.||0.19|-0.86|0.2135
73827944|NCT01668797|147202416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.2437|TWO_SIDED|95.0|-1.13|0.29|||ANCOVA|||Statistical analysis at Week 12.||0.29|-1.13|0.2437
73827945|NCT01668797|147202416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0635|TWO_SIDED|95.0|-1.66|0.05|||ANCOVA|||Statistical analysis at Week 24.||0.05|-1.66|0.0635
73827946|NCT01668797|147202416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.0144|TWO_SIDED|95.0|-1.92|-0.22|||ANCOVA|||Statistical analysis at Week 36.||-0.22|-1.92|0.0144
73827947|NCT01668797|147202416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.0046|TWO_SIDED|95.0|-2.12|-0.39|||ANCOVA|||Statistical analysis at Week 52.||-0.39|-2.12|0.0046
73827948|NCT01668797|147202417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.164|TWO_SIDED|95.0|-1.14|0.19|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.19|-1.14|0.1640
73827949|NCT01668797|147202417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.5466|TWO_SIDED|95.0|-1.04|0.55|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.55|-1.04|0.5466
73827950|NCT01668797|147202417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9417|TWO_SIDED|95.0|-0.81|0.87|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.87|-0.81|0.9417
73827951|NCT01668797|147202417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.6257|TWO_SIDED|95.0|-1.25|0.76|||Mixed Models Analysis|||Statistical analysis at Week 36.||0.76|-1.25|0.6257
73827952|NCT01668797|147202417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.7437|TWO_SIDED|95.0|-1.68|1.21|||Mixed Models Analysis|||Statistical analysis at Week 52.||1.21|-1.68|0.7437
73827953|NCT01668797|147202417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.4506|TWO_SIDED|95.0|-0.62|0.28|||Mixed Models Analysis|||Statistical analysis at across visits.||0.28|-0.62|0.4506
73827954|NCT01668797|147202418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0467|TWO_SIDED|95.0|-1.32|-0.06|||ANCOVA|||Statistical analysis at Week 6.||-0.06|-1.32|0.0467
73827955|NCT01668797|147202418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.1599|TWO_SIDED|95.0|-1.33|0.22|||ANCOVA|||Statistical analysis at Week 12.||0.22|-1.33|0.1599
73827956|NCT01668797|147202418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.1417|TWO_SIDED|95.0|-1.35|0.19|||ANCOVA|||Statistical analysis at Week 24.||0.19|-1.35|0.1417
73827957|NCT01668797|147202418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0724|TWO_SIDED|95.0|-1.47|0.06|||ANCOVA|||Statistical analysis at Week 36.||0.06|-1.47|0.0724
73827958|NCT01668797|147202418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.0608|TWO_SIDED|95.0|-1.47|0.03|||ANCOVA|||Statistical analysis at Week 52.||0.03|-1.47|0.0608
73827959|NCT01004614|147202419|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|98.61|||||TWO_SIDED|90.0|93.09|104.46|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||104.46|93.09|
73827960|NCT01004614|147202419|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|101.29|||||TWO_SIDED|90.0|97.28|105.45|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||105.45|97.28|
73827961|NCT01004614|147202420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|99.3|||||TWO_SIDED|90.0|92.28|106.28||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||106.28|92.28|
73827962|NCT01004614|147202420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|100.84|||||TWO_SIDED|90.0|95.93|106.0||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||106.00|95.93|
73827963|NCT02530385|147202426|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
73827964|NCT02530385|147202427|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
73827965|NCT02530385|147202428|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||||||0.93
73827966|NCT02530385|147202429|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.90
73827967|NCT02530385|147202430|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
73827968|NCT01569022|147202432|EQUIVALENCE|The primary endpoint of the study was tested by comparing difference in residual AHI using the paired t test|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73827969|NCT01569022|147202433|EQUIVALENCE|t test assuming unequal variance||||||0.97|||||||t-test, 2 sided|||ESS||||0.97
73827970|NCT01569022|147202433|EQUIVALENCE|t test assuming unequal variance||||||0.98|||||||t-test, 2 sided|||PCL||||0.98
73827971|NCT01569022|147202433|EQUIVALENCE|t-test assuming non unequal variance||||||0.31|||||||t-test, 2 sided|||PSQI||||0.31
73827972|NCT01569022|147202434|EQUIVALENCE|t test assuming unequal variance||||||0.54|||||||t-test, 2 sided|||||||0.54
73827973|NCT01569022|147202435|EQUIVALENCE|t test assuming unequal variance|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73827974|NCT02111083|147202437|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.986|||||TWO_SIDED|90.0|0.965|1.01||||||||1.01|0.965|
73827975|NCT02111083|147202438|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.872|||||TWO_SIDED|90.0|0.828|0.919||||||||0.919|0.828|
73827976|NCT02111083|147202439|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.25|||||TWO_SIDED|90.0|0.0|0.375||||||||0.375|0|
73827977|NCT02111083|147202440|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.986|||||TWO_SIDED|90.0|0.954|1.02||||||||1.02|0.954|
73827978|NCT02111083|147202441|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.95|||||TWO_SIDED|90.0|0.901|1.0||||||||1.00|0.901|
73827979|NCT02111083|147202442|SUPERIORITY_OR_OTHER||Difference of least squares means|0.424|||||TWO_SIDED|90.0|0.164|0.685||||||||0.685|0.164|
73827980|NCT02111083|147202443|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.992|||||TWO_SIDED|90.0|0.975|1.01||||||||1.01|0.975|
73827981|NCT00433836|147202449|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority delta of 3.5 mm Hg|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.8|1.17|||ANOVA|||||1.17|-3.80|
73827982|NCT00644059|147202454|SUPERIORITY_OR_OTHER||Vaccine Efficacy|81.36|||||TWO_SIDED|97.66|49.24|93.16|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||93.16|49.24|
73827983|NCT00644059|147202457|SUPERIORITY_OR_OTHER||Vaccine Efficacy|81.36|||||TWO_SIDED|95.0|49.24|93.16|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||93.16|49.24|
73827984|NCT00644059|147202457|SUPERIORITY_OR_OTHER||Vaccine Efficacy|95.5|||||TWO_SIDED|95.0|80.92|98.94|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||98.94|80.92|
73827985|NCT00644059|147202457|SUPERIORITY_OR_OTHER||Vaccine Efficacy|0.32|||||TWO_SIDED|95.0|0.13|0.73|||Mantel Haenszel|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||0.73|0.13|
73827986|NCT00644059|147202457|SUPERIORITY_OR_OTHER||Vaccine Efficacy|0.09|||||TWO_SIDED|95.0|0.02|0.38|||Mantel Haenszel|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||0.38|0.02|
73827987|NCT00644059|147202458|SUPERIORITY_OR_OTHER||vaccine Efficacy|79.18|||||TWO_SIDED|95.0|54.78|90.42|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||90.42|54.78|
73827988|NCT00644059|147202458|SUPERIORITY_OR_OTHER||Vaccine Efficacy|92.1|||||TWO_SIDED|95.0|77.35|97.24|||Poisson Regression Model|||Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza. Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)||97.24|77.35|
73827989|NCT00644059|147202458|SUPERIORITY_OR_OTHER||Vaccine Efficacy|64.16|||||TWO_SIDED|95.0|23.21|83.28|||Poisson Regression Model|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||83.28|23.21|
73827990|NCT00644059|147202458|SUPERIORITY_OR_OTHER||Vaccine Efficacy|85.66|||||TWO_SIDED|95.0|58.95|94.99|||Poisson Regression Model|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||94.99|58.95|
73827991|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|0.83|||||TWO_SIDED|95.0|0.67|1.02|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.02|0.67|
73827992|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|7.63|||||TWO_SIDED|95.0|5.42|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||11|5.42|
73827993|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|15.0|||||TWO_SIDED|95.0|11.0|21.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay||21|11|
73827994|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|6.48|||||TWO_SIDED|95.0|4.83|8.68|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay||8.68|4.83|
73827995|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|1.01|||||TWO_SIDED|95.0|0.85|1.21|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.21|0.85|
73827996|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|9.82|||||TWO_SIDED|95.0|7.76|12.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||12|7.76|
73827997|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|16.0|||||TWO_SIDED|95.0|12.0|20.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||20|12|
73827998|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|4.92|||||TWO_SIDED|95.0|3.64|6.65|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||6.65|3.64|
73827999|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|1.0|||||TWO_SIDED|95.0|0.91|1.1|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.1|0.91|
73828000|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|1.5|||||TWO_SIDED|95.0|1.19|1.9|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.9|1.19|
73828001|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|6.99|||||TWO_SIDED|95.0|5.72|8.53|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||8.53|5.72|
73828002|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|2.92|||||TWO_SIDED|95.0|2.44|3.5|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||3.5|2.44|
73828003|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.81|||||TWO_SIDED|95.0|0.64|1.04|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.04|0.64|
73828004|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[A/Solomon Islands/2006 (A/H1N1)]|1.21|||||TWO_SIDED|95.0|0.83|1.78|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.78|0.83|
73828005|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1]|7.54|||||TWO_SIDED|95.0|5.33|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||11|5.33|
73828006|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[A/Solomon Islands/2006 (A/H1N1)]|3.31|||||TWO_SIDED|95.0|2.4|4.55|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.55|2.4|
73828007|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|0.9|||||TWO_SIDED|95.0|0.74|1.1|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.1|0.74|
73828008|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT[A/Wisconsin/2009 (A/H3N2)]|3.54|||||TWO_SIDED|95.0|2.78|4.51|||GMT|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.51|2.78|
73828009|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|13.0|||||TWO_SIDED|95.0|10.0|16.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||16|10|
73828010|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|3.6|||||TWO_SIDED|95.0|2.61|4.95|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.95|2.61|
73828011|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|1.0|1.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1|1|
73828012|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.06|||||TWO_SIDED|95.0|1.02|1.11|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.11|1.02|
73828013|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.74|||||TWO_SIDED|95.0|1.57|1.92|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.92|1.57|
73828014|NCT00644059|147202464|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|0.92|1.08|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.08|0.92|
73828015|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|0.96|||||TWO_SIDED|95.0|0.78|1.19|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.19|0.78|
73828016|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|6.41|||||TWO_SIDED|95.0|4.69|8.76|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||8.76|4.69|
73828017|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|8.26|||||TWO_SIDED|95.0|6.36|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||11|6.36|
73828018|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|4.37|||||TWO_SIDED|95.0|3.38|5.65|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||5.65|3.38|
73828019|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|1.05|||||TWO_SIDED|95.0|0.82|1.35|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of Geometric Mean Titers GMTs in subjects aged 6 to \<72 months by HI assay.||1.35|0.82|
73828020|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|6.42|||||TWO_SIDED|95.0|4.72|8.73|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||8.73|4.72|
73828021|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|7.98|||||TWO_SIDED|95.0|6.2|10.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||10|6.2|
73828022|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|3.13|||||TWO_SIDED|95.0|2.42|4.05|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.05|2.42|
73828023|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|0.97|||||TWO_SIDED|95.0|0.9|1.05|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.05|0.9|
73828024|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|1.56|||||TWO_SIDED|95.0|1.26|1.93|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.93|1.26|
73828025|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|5.0|||||TWO_SIDED|95.0|4.25|5.88|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||5.88|4.25|
73828026|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|2.55|||||TWO_SIDED|95.0|2.22|2.93|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||2.93|2.22|
73828027|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.96|||||TWO_SIDED|95.0|0.75|1.22|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.22|0.75|
73828028|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|1.72|||||TWO_SIDED|95.0|1.17|2.51|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||2.51|1.17|
73828029|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|5.58|||||TWO_SIDED|95.0|4.08|7.63|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||7.63|4.08|
73828030|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|3.11|||||TWO_SIDED|95.0|2.3|4.2|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.2|2.3|
73828031|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|0.98|||||TWO_SIDED|95.0|0.74|1.3|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.3|0.74|
73828032|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|3.14|||||TWO_SIDED|95.0|2.19|4.49|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.49|2.19|
73828033|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|7.36|||||TWO_SIDED|95.0|5.51|9.82|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||9.82|5.51|
73828034|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|2.66|||||TWO_SIDED|95.0|2.0|3.55|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||3.55|2|
73828035|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|0.98|1.01|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.01|0.98|
73828036|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.13|||||TWO_SIDED|95.0|1.05|1.22|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.22|1.05|
73828037|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.79|||||TWO_SIDED|95.0|1.63|1.97|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.97|1.63|
73828038|NCT00644059|147202467|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.08|||||TWO_SIDED|95.0|1.0|1.17|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.17|1|
73828039|NCT01924533|147202640|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.0262|TWO_SIDED|97.5|0.63|1.0|||Cox proportional hazards model|||||1.00|0.63|0.0262
73828040|NCT01924533|147202641|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.2458|TWO_SIDED|97.5|0.4|1.34|||Cox proportional hazards model|||||1.34|0.40|0.2458
73828041|NCT01924533|147202642|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.0645|TWO_SIDED|97.5|0.67|1.04|||Cox proportional hazards model|||||1.04|0.67|0.0645
73828042|NCT01924533|147202643|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.2199|TWO_SIDED|97.5|0.42|1.29|||Cox proportional hazards model|||||1.29|0.42|0.2199
73828043|NCT01924533|147202644|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.69||||0.0548|TWO_SIDED|97.5|0.92|3.17|||Regression, Logistic|||||3.17|0.92|0.0548
73828044|NCT01924533|147202645|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.24||||0.0309|TWO_SIDED|97.5|0.95|23.23|||Regression, Logistic|||||23.23|0.95|0.0309
73828045|NCT01924533|147202646|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0716|TWO_SIDED|97.5|0.64|1.05|||Cox proportional hazards model|||||1.05|0.64|0.0716
73828046|NCT01924533|147202647|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0927|TWO_SIDED|97.5|0.34|1.16|||Cox proportional hazards model|||||1.16|0.34|0.0927
73828047|NCT03307174|147202653|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
73828048|NCT04275336|147202660|OTHER||H value|1.344||||0.511|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.511
73828049|NCT04275336|147202661|OTHER||H value|5.272||||0.072|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.072
73828050|NCT04275336|147202662|OTHER||H value|0.198||||0.906|ONE_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.906
73828051|NCT04275336|147202663|OTHER||H value|6.679||||0.035|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.035
73828052|NCT04275336|147202664|OTHER||Mean Difference (Final Values)|0.17||||0.844|TWO_SIDED|95.0||||\<0.05|ANOVA|||||||0.844
73828053|NCT04275336|147202665|OTHER||H value|1.651||||0.438|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.438
73828054|NCT04275336|147202666|OTHER||H value|0.341||||0.843|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.843
73828055|NCT04275336|147202667|OTHER||Median Difference (Final Values)|1.642||||0.44|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.440
73828056|NCT04664205|147202671|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
73828057|NCT04664205|147202672|SUPERIORITY|||||||0.069|||||||ANCOVA|||||||0.069
73828058|NCT04664205|147202673|SUPERIORITY|||||||0.478|||||||ANOVA|||||||0.478
73828059|NCT02343224|147202675|OTHER||Kaplan-Meier estimate|76.2|||||TWO_SIDED|95.0|52.1|100.0||||||This Kaplan-Meier estimate is the conditional probability of event-free survival among study participants at 12 and 24 months.||100|52.1|
73828060|NCT02343224|147202676|OTHER||Kaplan-Meier estimate|75.0|||||TWO_SIDED|95.0|50.3|100.0||||||This Kaplan-Meier estimate is the conditional probability of overall survival among participants at 12 and 24 months.||100|50.3|
73828061|NCT00461734|147202690|SUPERIORITY_OR_OTHER|||||||0.4347|||||||two-sided z-test|||||||0.4347
73828062|NCT00461734|147202691|SUPERIORITY_OR_OTHER|||||||0.338|||||||two-sided z-test|||||||0.338
73828063|NCT00461734|147202692|SUPERIORITY_OR_OTHER|||||||0.2257|||||||Wilcoxon (Mann-Whitney)|||||||0.2257
73828064|NCT00461734|147202693|SUPERIORITY_OR_OTHER|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||||||0.5480
73828065|NCT00461734|147202694|SUPERIORITY_OR_OTHER|||||||0.8868|||||||Wilcoxon (Mann-Whitney)|||||||0.8868
73828066|NCT00461734|147202695|SUPERIORITY_OR_OTHER|||||||0.6151|||||||Wilcoxon (Mann-Whitney)|||||||0.6151
73828067|NCT00461734|147202699|SUPERIORITY_OR_OTHER|||||||0.0525|||||||t-test, 2 sided|||||||0.0525
73828068|NCT00461734|147202700|SUPERIORITY_OR_OTHER|||||||0.1852|||||||t-test, 2 sided|||||||0.1852
73828069|NCT00461734|147202702|SUPERIORITY_OR_OTHER|||||||0.9719|||||||Wilcoxon (Mann-Whitney)|||||||0.9719
73828070|NCT00461734|147202703|SUPERIORITY_OR_OTHER|||||||0.8779|||||||Wilcoxon (Mann-Whitney)|||||||0.8779
73828071|NCT00721799|147202723|OTHER||Hazard Ratio (HR)|0.47||||0.08|TWO_SIDED||||||Regression, Cox|||||||0.08
73828072|NCT00721799|147202723|OTHER||C-statistic|0.73||||0.04|TWO_SIDED||||||Regression, Cox|||||||0.04
73828073|NCT00721799|147202724|OTHER||Hazard Ratio (HR)|0.42||||0.05|TWO_SIDED||||||Regression, Cox|||||||0.05
73828074|NCT00721799|147202724|OTHER||C-statistic|0.75||||0.02|TWO_SIDED||||||Regression, Cox|||||||0.02
73828075|NCT00721799|147202725|OTHER||Hazard Ratio (HR)|2.44|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
73828076|NCT00721799|147202725|OTHER||C-statistic|0.74||||0.02|TWO_SIDED||||||Regression, Cox|||||||0.02
73828077|NCT00721799|147202726|OTHER||Hazard Ratio (HR)|1.12||||0.73|TWO_SIDED||||||Regression, Cox|||||||0.73
73828078|NCT00721799|147202726|OTHER||C-statistic|0.52||||0.88|TWO_SIDED||||||Regression, Cox|||||||0.88
73828079|NCT00721799|147202727|OTHER||Hazard Ratio (HR)|1.11||||0.78|TWO_SIDED||||||Regression, Cox|||||||0.78
73828080|NCT00721799|147202727|OTHER||C-statistic|0.45||||0.66|TWO_SIDED||||||Regression, Cox|||||||0.66
73828081|NCT00721799|147202728|OTHER||Hazard Ratio (HR)|2.25||||0.01|TWO_SIDED||||||Regression, Cox|||||||0.01
73828082|NCT00721799|147202728|OTHER||C-statistic|0.7||||0.05|TWO_SIDED||||||Regression, Cox|||||||0.05
73828083|NCT00721799|147202729|OTHER||Hazard Ratio (HR)|0.83||||0.63|TWO_SIDED||||||Regression, Cox|||||||0.63
73828084|NCT00721799|147202729|OTHER||C-statistic|0.58||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
73828085|NCT00721799|147202730|OTHER||Hazard Ratio (HR)|0.81||||0.58|TWO_SIDED||||||Regression, Cox|||||||0.58
73828086|NCT00721799|147202730|OTHER||C-statistic|0.6||||0.36|TWO_SIDED||||||Regression, Cox|||||||0.36
73828087|NCT00721799|147202731|OTHER||Hazard Ratio (HR)|0.94||||0.89|TWO_SIDED||||||Regression, Cox|||||||0.89
73828088|NCT00721799|147202731|OTHER||C-statistic|0.59||||0.42|TWO_SIDED||||||Regression, Cox|||||||0.42
73828089|NCT00721799|147202732|OTHER||Hazard Ratio (HR)|1.29||||0.43|TWO_SIDED||||||Regression, Cox|||||||0.43
73828090|NCT00721799|147202732|OTHER||C-statistic|0.47||||0.8|TWO_SIDED||||||Regression, Cox|||||||0.80
73828091|NCT00721799|147202733|OTHER||Hazard Ratio (HR)|2.01||||0.01|TWO_SIDED||||||Regression, Cox|||||||0.01
73828092|NCT00721799|147202733|OTHER||C-statistic|0.69||||0.07|TWO_SIDED||||||Regression, Cox|||||||0.07
73828093|NCT00721799|147202734|OTHER||Hazard Ratio (HR)|1.58||||0.18|TWO_SIDED||||||Regression, Cox|||||||0.18
73828094|NCT00721799|147202734|OTHER||C-statistic|0.63||||0.25|TWO_SIDED||||||Regression, Cox|||||||0.25
73828095|NCT00721799|147202735|OTHER||Hazard Ratio (HR)|1.49||||0.24|TWO_SIDED||||||Regression, Cox|||||||0.24
73828096|NCT00721799|147202735|OTHER||C-statistic|0.62||||0.27|TWO_SIDED||||||Regression, Cox|||||||0.27
73828097|NCT00721799|147202736|OTHER||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED||||||Regression, Cox|||||||0.99
73828098|NCT00721799|147202736|OTHER||C-statistic|0.48||||0.84|TWO_SIDED||||||Regression, Cox|||||||0.84
73828099|NCT00721799|147202737|OTHER||Hazard Ratio (HR)|1.3||||0.41|TWO_SIDED||||||Regression, Cox|||||||0.41
73828100|NCT00721799|147202737|OTHER||C-statistic|0.54||||0.69|TWO_SIDED||||||Regression, Cox|||||||0.69
73828101|NCT00721799|147202738|OTHER||Hazard Ratio (HR)|1.56||||0.17|TWO_SIDED||||||Regression, Cox|||||||0.17
73828102|NCT00721799|147202738|OTHER||C-statistic|0.64||||0.18|TWO_SIDED||||||Regression, Cox|||||||0.18
73828103|NCT00721799|147202739|OTHER||Hazard Ratio (HR)|0.42||||0.09|TWO_SIDED||||||Regression, Cox|||||||0.09
73828104|NCT00721799|147202739|OTHER||Hazard Ratio (HR)|0.72||||0.06|TWO_SIDED||||||Regression, Cox|||||||0.06
73828105|NCT00721799|147202740|OTHER||Hazard Ratio (HR)|0.36||||0.06|TWO_SIDED||||||Regression, Cox|||||||0.06
73828106|NCT00721799|147202740|OTHER||C-statistic|0.74||||0.04|TWO_SIDED||||||Regression, Cox|||||||0.04
73828107|NCT00721799|147202741|OTHER||Hazard Ratio (HR)|3.01|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
73828108|NCT00721799|147202741|OTHER||C-statistic|0.82|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
73828109|NCT00721799|147202742|OTHER||Hazard Ratio (HR)|1.03||||0.92|TWO_SIDED||||||Regression, Cox|||||||0.92
73828110|NCT00721799|147202742|OTHER||C-statistic|0.48||||0.84|TWO_SIDED||||||Regression, Cox|||||||0.84
73828111|NCT00721799|147202743|OTHER||Hazard Ratio (HR)|1.11||||0.76|TWO_SIDED||||||Regression, Cox|||||||0.76
73828112|NCT00721799|147202743|OTHER||C-statistic|0.45||||0.68|TWO_SIDED||||||Regression, Cox|||||||0.68
73828113|NCT00721799|147202744|OTHER||Hazard Ratio (HR)|2.99|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
73828114|NCT00721799|147202744|OTHER||C-statistic|0.74||||0.03|TWO_SIDED||||||Regression, Cox|||||||0.03
73828115|NCT00721799|147202745|OTHER||Hazard Ratio (HR)|0.78||||0.55|TWO_SIDED||||||Regression, Cox|||||||0.55
73828116|NCT00721799|147202745|OTHER||C-statistic|0.61||||0.35|TWO_SIDED||||||Regression, Cox|||||||0.35
73828117|NCT00721799|147202746|OTHER||Hazard Ratio (HR)|0.74||||0.48|TWO_SIDED||||||Regression, Cox|||||||0.48
73828118|NCT00721799|147202746|OTHER||C-statistic|0.63||||0.28|TWO_SIDED||||||Regression, Cox|||||||0.28
73828119|NCT00721799|147202747|OTHER||Hazard Ratio (HR)|0.81||||0.67|TWO_SIDED||||||Regression, Cox|||||||0.67
73828120|NCT00721799|147202747|OTHER||C-statistic|0.71||||0.11|TWO_SIDED||||||Regression, Cox|||||||0.11
73828121|NCT00721799|147202748|OTHER||Hazard Ratio (HR)|1.32||||0.4|TWO_SIDED||||||Regression, Cox|||||||0.40
73828122|NCT00721799|147202748|OTHER||C-statistic|0.48||||0.88|TWO_SIDED||||||Regression, Cox|||||||0.88
73828123|NCT00721799|147202749|OTHER||Hazard Ratio (HR)|2.39|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
73828124|NCT00721799|147202749|OTHER||C-statistic|0.74||||0.03|TWO_SIDED||||||Regression, Cox|||||||0.03
73828125|NCT00721799|147202750|OTHER||Hazard Ratio (HR)|1.51||||0.26|TWO_SIDED||||||Regression, Cox|||||||0.26
73828126|NCT00721799|147202750|OTHER||C-statistic|0.59||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
73828127|NCT00721799|147202751|OTHER||Hazard Ratio (HR)|1.38||||0.37|TWO_SIDED||||||Regression, Cox|||||||0.37
73828128|NCT00721799|147202751|OTHER||C-statistic|0.59||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
73828129|NCT00721799|147202752|OTHER||Hazard Ratio (HR)|1.05||||0.9|TWO_SIDED||||||Regression, Cox|||||||0.90
73828130|NCT00721799|147202752|OTHER||C-statistic|0.52||||0.87|TWO_SIDED||||||Regression, Cox|||||||0.87
73828131|NCT00721799|147202753|OTHER||Hazard Ratio (HR)|1.35||||0.36|TWO_SIDED||||||Regression, Cox|||||||0.36
73828132|NCT00721799|147202753|OTHER||C-statistic|0.56||||0.63|TWO_SIDED||||||Regression, Cox|||||||0.63
73828133|NCT00721799|147202754|OTHER||Hazard Ratio (HR)|1.56||||0.2|TWO_SIDED||||||Regression, Cox|||||||0.20
73828134|NCT00721799|147202754|OTHER||C-statistic|0.63||||0.24|TWO_SIDED||||||Regression, Cox|||||||0.24
73828135|NCT03141359|147202755|SUPERIORITY||Rate|0.627||||0.388|TWO_SIDED|95.0|0.492|0.75|||Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|We used a single-stage design to test null hypothesis (H0) that 1-yr PFS is \<= 0.60. Assuming one-sided α= 0.10, 60 patients provided 98% power to reject H0, assuming the true 1-yr PFS is 0.80. Since not all enrolled subjects received durva, study power was affected. For patients who did not receive durva, H0 was assumed to be 0.40 versus an alternative of 0.60. Including these subjects reduced power from 98%. The conditional power given that 13 evaluable subjects didn't receive durva was 88%.||0.750|0.492|.388
73828136|NCT03141359|147202758|OTHER|Estimation only|Rate|0.571|||||TWO_SIDED|95.0|0.422|0.712|||||Confidence interval estimated using the Clopper Pearson method.|||0.712|0.422|
73828137|NCT03141359|147202759|OTHER|Estimation only|Rate|0.75|||||TWO_SIDED|95.0|0.621|0.853|||||Confidence interval estimated using the Clopper Pearson method.|||0.853|0.621|
73828138|NCT03141359|147202767|OTHER|Estimation only|Rate|0.164|||||TWO_SIDED|95.0|0.082|0.281|||||Confidence interval estimated using the Clopper Pearson method.|||0.281|0.082|
73828139|NCT03141359|147202768|OTHER|Estimation only|Rate|0.246|||||TWO_SIDED|95.0|0.145|0.373|||||Confidence interval estimated using the Clopper Pearson method.|||0.373|0.145|
73828140|NCT01081626|147202774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0135||||0.956|TWO_SIDED|95.0|-0.1325|0.1637|||Chi-squared, Corrected|||||0.1637|-0.1325|0.9560
73828141|NCT01081626|147202775|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.088||||0.7924|TWO_SIDED|95.0|0.7642|1.549|||Chi-squared|||||1.5490|0.7642|0.7924
73828142|NCT01081626|147202779|SUPERIORITY_OR_OTHER|||||||0.5331||95.0|||||Chi-squared|||||||0.5331
73828143|NCT01081626|147202780|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.015||||0.9351|TWO_SIDED|95.0|0.7175|1.435|||Chi-squared|||||1.4350|0.7175|0.9351
73828144|NCT01450813|147202818|NON_INFERIORITY_OR_EQUIVALENCE|Sample size needed for a one-way ANOVA test with an alpha of 0.05 and power of 0.8 to rule out the null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence was a total of 64 or 16 per Group.|||||<|0.05||||||Comparisons of the means were accomplished via student's t-test with Bonferroni correction for multiple comparisons.|ANOVA|||Null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence.||||< 0.05
73828145|NCT01935089|147202821|OTHER|"Hypothesis: 20 weeks of treatment (baseline week 3 to endpoint week 24) will result in a change in the levels of integrated HIV-1 DNA (copies/CD4 T cell Variable name: intDNA).~Test if the mean difference (IntDNA wk24 - IntDNAwk3) is significantly different from zero (i.e. no change) Null hypothesis: Mean (IntDNA wk24 - IntDNAwk3) = 0; reject if p\<0.05"||||||0.0797||||||significant if \<0.05|signed rank test|||||||0.0797
73828146|NCT00723229|147202867|SUPERIORITY_OR_OTHER||Incidence Risk Ratio|0.2|||<|0.001|TWO_SIDED|95.0|0.17|0.25|||Regression, poisson|Adjusted for period effects.||The trial had 80% power to detect a 35% reduction in genital shedding rates for acyclovir 400 mg twice daily.||0.25|0.17|<0.001
73828147|NCT00723229|147202867|SUPERIORITY|Adjusted for period effects.|Risk Ratio (RR)|0.05|||<|0.001|TWO_SIDED|95.0|0.03|0.08|||Regression, Poisson|||Among HIV seronegative individuals.||0.08|0.03|<0.001
73828148|NCT00723229|147202867|SUPERIORITY|Adjusted for period effects.|Risk Ratio (RR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.6|||Regression, Poisson|||Among HIV seropositive individuals.||0.6|0.4|<0.001
73828149|NCT03073486|147202875|OTHER|||||||0.2301|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.2301
73828150|NCT03073486|147202876|OTHER|||||||0.6888|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.6888
73828151|NCT03073486|147202877|OTHER|||||||0.1361|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation||||||0.1361
73828152|NCT03435055|147202884|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Paired t-test were conducted on subject specific beta maps to identify changes in connectivity associated with nitrous oxide in SPM12. Hypothesis was that the results would be deemed significant at false discovery rate (FDR) cluster level corrected p \< 0.05 derived from a voxel-wise uncorrected p-value \< 0.001.||||0.001
73828153|NCT03435055|147202885|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Paired t-test were conducted on subject specific beta maps to identify changes in connectivity associated with nitrous oxide in SPM12. Hypothesis was that results would be deemed significant at false discovery rate (FDR) cluster level corrected p \< 0.05 derived from a voxel-wise uncorrected p-value \< 0.001.||||0.006
73828154|NCT03435055|147202886|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Paired-t tests were conducted to determine whether changes in stimulus intensity: post stimulus at baseline and under subanesthetic dose of nitrous oxide. Statistical tests were completed in SPSS 26 and determined by p \< 0.05.||||<0.01
73828155|NCT03435055|147202887|OTHER|Paired T-test comparing baseline to nitrous||||||0.0622|||||||Paired t-test|||Delta||||0.0622
73828156|NCT03435055|147202887|OTHER|Paired T-test comparing baseline to nitrous||||||0.0292|||||||Paired t-test|||Theta||||0.0292
73828157|NCT03435055|147202887|OTHER|Paired T-test comparing baseline to nitrous||||||0.5905|||||||Paired t-test|||Alpha comparison||||0.5905
73828158|NCT03558516|147202905|SUPERIORITY|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||||||0.315
73828159|NCT03558516|147202906|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
73828160|NCT03558516|147202907|SUPERIORITY|||||||0.299|||||||Wilcoxon (Mann-Whitney)|||||||0.299
73828161|NCT00572832|147202969|NON_INFERIORITY_OR_EQUIVALENCE|The formula used for calculating sample size for the treatment arm (NT) is NT = (1 + 1/u) (Zα + Zβ)2 σ2 /\[log (RGMC) -δ0\] where u is the ratio of the size of the control and treatment arms, one sided alpha that is divided by 4, a non-inferiority margin (δ0 of natural log 0.5), the expected ratio of geometric mean concentrations RGMC set at 0.8, and a standard deviation of 1.26 (the largest for HPV-16). The calculated sample size for a power of 80% was 75 participants in each arm.||||||0.025||95.0||||Non-inferiority was tested against a one-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type. Results: GMT ratios were 2.23, 3,17, 2.14, and 1.68 for types 6,11,16,\& 18.|ANOVA|Log transformed the data and calculated GMTs. Tested if post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type||Non-inferiority tested against 1-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type||||.025
73828162|NCT00966433|147202970|OTHER||Mean Difference (Final Values)|-8.2||||0.0051|TWO_SIDED|95.0|-13.61|-2.79|||t-test, 2 sided|||||-2.79|-13.61|.0051
73828163|NCT00966433|147202971|OTHER||Mean Difference (Final Values)|3.6||||0.0001|TWO_SIDED|95.0|2.97|4.23|||t-test, 2 sided|||||4.23|2.97|.0001
73828164|NCT00966433|147202976|OTHER||Mean Difference (Final Values)|-13.9||||0.0001|TWO_SIDED|95.0|-18.88|-8.92|||t-test, 2 sided|||||-8.92|-18.88|.0001
73828165|NCT01704261|147202979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.85|-0.38|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.||||-0.38|-0.85|<0.001
73828166|NCT01704261|147202980|SUPERIORITY_OR_OTHER||Difference in % Omarigliptin vs Placebo|9.8|||||TWO_SIDED|95.0|-1.4|20.8||||||||20.8|-1.4|
73828167|NCT01704261|147202981|SUPERIORITY_OR_OTHER||Difference in % Omarigliptin vs Placebo|0.0|||||TWO_SIDED|95.0|-4.3|4.3||||||||4.3|-4.3|
73828168|NCT01704261|147202982|SUPERIORITY_OR_OTHER||Difference of the least squares means|-16.6|||<|0.001|TWO_SIDED|95.0|-25.5|-7.8|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.||||-7.8|-25.5|<0.001
73828169|NCT01704261|147202983|SUPERIORITY_OR_OTHER||Between-group Rate Difference|19.3|||<|0.001|TWO_SIDED|95.0|11.7|27.6|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C \<7.0%; estimated using standard multiple imputation techniques.||||27.6|11.7|<0.001
73828170|NCT01704261|147202983|SUPERIORITY_OR_OTHER||Between-group Rate Difference (%)|8.0||||0.005|TWO_SIDED|95.0|2.7|14.5|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C \<7.0%; estimated using standard multiple imputation techniques.||||14.5|2.7|0.005
73828171|NCT00111761|147202988|SUPERIORITY_OR_OTHER||Percentage of participants|25.0||||||95.0|9.8|46.7||||||||46.7|9.8|
73828172|NCT00111761|147202989|SUPERIORITY_OR_OTHER||Percentage of participants|58.0||||||95.0|34.0|80.0||||||||80|34|
73828173|NCT00111761|147202990|SUPERIORITY_OR_OTHER||Percentage|33.3||||||95.0|15.6|55.3||||||||55.3|15.6|
73828174|NCT00111761|147202995|SUPERIORITY_OR_OTHER||Percentage of participants|47.4||||||95.0|24.4|71.1||||||||71.1|24.4|
73828175|NCT00843492|147203032|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.15|0.54|||Fisher Exact|||||0.54|0.15|<0.001
73828176|NCT00720499|147203057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.017||0.8937|TWO_SIDED|95.0|-0.035|0.031|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.031|-0.035|0.8937
73828177|NCT00720499|147203058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.019||0.2425|TWO_SIDED|95.0|-0.015|0.061|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.061|-0.015|0.2425
73828178|NCT00720499|147203060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.008||0.5198|TWO_SIDED|95.0|-0.01|0.021|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.021|-0.010|0.5198
73828179|NCT00720499|147203060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.211|TWO_SIDED|95.0|-0.011|0.051|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.051|-0.011|0.2110
73828180|NCT00720499|147203060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.014||0.9368|TWO_SIDED|95.0|-0.029|0.027|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.027|-0.029|0.9368
73828181|NCT00720499|147203061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.01||0.5339|TWO_SIDED|95.0|-0.027|0.014|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.014|-0.027|0.5339
73828182|NCT00720499|147203061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.019||0.2408|TWO_SIDED|95.0|-0.015|0.058|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.058|-0.015|0.2408
73828183|NCT00720499|147203061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.018||0.7139|TWO_SIDED|95.0|-0.029|0.042|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.042|-0.029|0.7139
73828184|NCT00720499|147203062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.015||0.7906|TWO_SIDED|95.0|-0.026|0.034|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.034|-0.026|0.7906
73828185|NCT00720499|147203063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.038||0.8473|TWO_SIDED|95.0|-0.067|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.082|-0.067|0.8473
73828186|NCT00720499|147203064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.031||0.2944|TWO_SIDED|95.0|-0.029|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.094|-0.029|0.2944
73828187|NCT00720499|147203064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.028||0.718|TWO_SIDED|95.0|-0.046|0.066|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.066|-0.046|0.7180
73828188|NCT00720499|147203066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.015||0.9384|TWO_SIDED|95.0|-0.029|0.032|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.032|-0.029|0.9384
73828189|NCT00720499|147203066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.1583|TWO_SIDED|95.0|-0.014|0.088|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.088|-0.014|0.1583
73828190|NCT00720499|147203066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.027||0.2914|TWO_SIDED|95.0|-0.025|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.082|-0.025|0.2914
73828191|NCT00720499|147203067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.03||0.2485|TWO_SIDED|95.0|-0.024|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.094|-0.024|0.2485
73828192|NCT00720499|147203068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.043||0.2875|TWO_SIDED|95.0|-0.039|0.13|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.130|-0.039|0.2875
73828193|NCT00720499|147203069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.984|STANDARD_ERROR_OF_MEAN|2.038||0.6299|TWO_SIDED|95.0|-3.046|5.015|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.015|-3.046|0.6299
73828194|NCT00720499|147203069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.311|STANDARD_ERROR_OF_MEAN|3.156||0.0475|TWO_SIDED|95.0|0.07|12.553|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||12.553|0.070|0.0475
73828195|NCT00720499|147203069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.552|STANDARD_ERROR_OF_MEAN|2.67||0.562|TWO_SIDED|95.0|-3.729|6.833|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.833|-3.729|0.5620
73828196|NCT00720499|147203070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.179|STANDARD_ERROR_OF_MEAN|2.342||0.9391|TWO_SIDED|95.0|-4.812|4.454|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||4.454|-4.812|0.9391
73828197|NCT00720499|147203070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48|STANDARD_ERROR_OF_MEAN|3.559||0.0709|TWO_SIDED|95.0|-0.56|13.52|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||13.520|-0.560|0.0709
73828198|NCT00720499|147203070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.099|STANDARD_ERROR_OF_MEAN|3.134||0.3245|TWO_SIDED|95.0|-3.1|9.298|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||9.298|-3.100|0.3245
73828199|NCT00720499|147203071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|4.655||0.8808|TWO_SIDED|95.0|-9.914|8.514|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||8.514|-9.914|0.8808
73828200|NCT00720499|147203072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.119|STANDARD_ERROR_OF_MEAN|2.177||0.6081|TWO_SIDED|95.0|-3.19|5.429|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.429|-3.190|0.6081
73828201|NCT00720499|147203072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.339|STANDARD_ERROR_OF_MEAN|2.342||0.5686|TWO_SIDED|95.0|-3.296|5.973|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.973|-3.296|0.5686
73828202|NCT00720499|147203072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.653|STANDARD_ERROR_OF_MEAN|2.294||0.7765|TWO_SIDED|95.0|-3.888|5.194|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.194|-3.888|0.7765
73828203|NCT00720499|147203072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.654|STANDARD_ERROR_OF_MEAN|2.543||0.5166|TWO_SIDED|95.0|-3.379|6.686|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.686|-3.379|0.5166
73828204|NCT00720499|147203073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.303|STANDARD_ERROR_OF_MEAN|2.585||0.2037|TWO_SIDED|95.0|-1.813|8.418|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||8.418|-1.813|0.2037
73828205|NCT00720499|147203073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.393|STANDARD_ERROR_OF_MEAN|2.738||0.6118|TWO_SIDED|95.0|-4.027|6.813|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.813|-4.027|0.6118
73828206|NCT00720499|147203073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.695|STANDARD_ERROR_OF_MEAN|2.498||0.4988|TWO_SIDED|95.0|-3.251|6.64|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.640|-3.251|0.4988
73828207|NCT00720499|147203073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.039|STANDARD_ERROR_OF_MEAN|2.478||0.6757|TWO_SIDED|95.0|-5.944|3.865|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||3.865|-5.944|0.6757
73828208|NCT00720499|147203074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.08||0.8901|TWO_SIDED|95.0|-0.147|0.169|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.169|-0.147|0.8901
73828209|NCT00720499|147203074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.086||0.1647|TWO_SIDED|95.0|-0.29|0.05|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.050|-0.290|0.1647
73828210|NCT00720499|147203074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.09||0.9822|TWO_SIDED|95.0|-0.18|0.176|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.176|-0.180|0.9822
73828211|NCT00720499|147203074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6542|TWO_SIDED|95.0|-0.218|0.137|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.137|-0.218|0.6542
73828212|NCT00720499|147203075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.114|STANDARD_ERROR_OF_MEAN|0.116||0.3269|TWO_SIDED|95.0|-0.342|0.115|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for treatment, centre, patient within centre and period (all effects fixed).||0.115|-0.342|0.3269
73828213|NCT00720499|147203076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.089||0.9557|TWO_SIDED|95.0|-0.181|0.171|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.171|-0.181|0.9557
73828214|NCT00720499|147203076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.08||0.8096|TWO_SIDED|95.0|-0.178|0.14|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.140|-0.178|0.8096
73828215|NCT01621009|147203137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||>|0.05|TWO_SIDED|95.0|0.78|3.36|||Regression, Logistic|||||3.36|.78|>0.05
73828216|NCT01621009|147203137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||>|0.05|TWO_SIDED|95.0|0.52|2.44|||Regression, Logistic|||||2.44|.52|>0.05
73828217|NCT00855218|147203162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.072||95.0|0.588|1.08||stratified one-sided (alpha=0.15). adjusted for region and Alfa-fetoprotein (AFP) level at baseline.|Log Rank|||||1.080|0.588|0.072
73828218|NCT00855218|147203163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.295||95.0|0.606|1.33|||Log Rank|stratified one-sided (alpha=0.15). adjusted for region and AFP level at baseline.||||1.330|0.606|0.295
73828219|NCT00855218|147203164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.586||||0.999||95.0|1.2|2.096|||Log Rank|startified one-sided (alpha=0.15), adjusted for region and AFP level at baseline||||2.096|1.200|0.999
73828220|NCT00855218|147203165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.621||||0.076||95.0|0.321|1.2|||Log Rank|stratified one sided (alpha=0.15), adjusted on region and AFP level at baseline||||1.200|0.321|0.076
73828221|NCT03191552|147203177|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73828222|NCT03191552|147203178|SUPERIORITY|||||||0.027||||||Mann-Whitney U test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.027
73828223|NCT03191552|147203179|SUPERIORITY|||||||0.008||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.008
73828224|NCT03191552|147203180|SUPERIORITY|Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.||||||0.004||||||Mann-WhitneyU test was performed to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.004
73828225|NCT03191552|147203181|SUPERIORITY|||||||0.837|||||||Kruskal-Wallis|||||||0.837
73828226|NCT03191552|147203182|SUPERIORITY|||||||0.57|||||||Kruskal-Wallis|||||||0.570
73828227|NCT03191552|147203183|SUPERIORITY|||||||0.334|||||||Kruskal-Wallis|||||||0.334
73828228|NCT03191552|147203184|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
73828229|NCT03191552|147203185|SUPERIORITY|||||||0.77|||||||Kruskal-Wallis|||||||0.77
73828230|NCT03191552|147203186|SUPERIORITY|||||||0.889|||||||Kruskal-Wallis|||||||0.889
73828231|NCT03191552|147203187|SUPERIORITY|||||||0.956|||||||Kruskal-Wallis|||||||0.956
73828232|NCT03191552|147203188|SUPERIORITY||||||,|0||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0,001
73828233|NCT03191552|147203189|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||||||0.14
73828234|NCT03191552|147203190|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
73828235|NCT03191552|147203191|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
73828236|NCT03191552|147203192|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
73828237|NCT03191552|147203193|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
73828238|NCT01149655|147203200|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.461||||0.0161|TWO_SIDED|95.0|0.242|0.879|||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.|Hazard ratios and their 95% confidence intervals were derived from the Cox Proportional Hazard model with treatment as term. Hazard ratio \< 1 is in favor of oral aripiprazole 10-30 mg group for superiority test.|The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||0.879|0.242|0.0161
73828239|NCT01149655|147203202|SUPERIORITY_OR_OTHER|||||||0.0962|TWO_SIDED||||||Chi-squared|p-value was derived using Chi-square test.||Statistical Analysis for Last Visit. The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0962
73828240|NCT01149655|147203203|SUPERIORITY_OR_OTHER|||||||0.9025|TWO_SIDED||||||Chi-squared|p-value was derived using Chi-square test.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.9025
73828241|NCT01149655|147203204|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||Log Rank|p-value was derived from the log-rank tests.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0076
73828242|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.3862|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis at Baseline. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.3862
73828243|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.8861|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 1. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.8861
73828244|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.8189|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 2. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.8189
73828245|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.3689|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 3. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.3689
73828246|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.9723|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 4. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.9723
73828247|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.2985|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 6. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.2985
73828248|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0883|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 8. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0883
73828249|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0228|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 10. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0228
73828250|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0274|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 12. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0274
73828251|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0135|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 14. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0135
73828252|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 16. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0059
73828253|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 18. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0076
73828254|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 20. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0065
73828255|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0175|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 22. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0175
73828256|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0107|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 24. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0107
73828257|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0118|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 26. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0118
73828258|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0232|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 28. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0232
73828259|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0337|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 30. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0337
73828260|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0507|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 32. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0507
73828261|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0791|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 34. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0791
73828262|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0898|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 36. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0898
73828263|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0686|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 38. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0686
73828264|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0833|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 40. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0833
73828265|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0824|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 42. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0824
73828266|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0686|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 44. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0686
73828267|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0737|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 46. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0737
73828268|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0893|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 48. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0893
73828269|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0706|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 50. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0706
73828270|NCT01149655|147203207|SUPERIORITY_OR_OTHER|||||||0.0657|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 52. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0657
73828271|NCT05079321|147203211|OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
73828272|NCT05079321|147203212|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.36
73828273|NCT05079321|147203213|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
73828274|NCT05079321|147203214|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
73828275|NCT05079321|147203215|OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
73828276|NCT05079321|147203216|OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.07
73828277|NCT05079321|147203217|OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
73828278|NCT05079321|147203218|OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
73828279|NCT05079321|147203220|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
73828280|NCT05079321|147203221|OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
73828281|NCT05079321|147203222|OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
73828282|NCT05079321|147203223|OTHER|||||||0.75|||||||Fisher Exact|||||||0.75
73828283|NCT05079321|147203224|OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
73828284|NCT05079321|147203225|OTHER|||||||0.69|||||||Fisher Exact|||||||0.69
73828285|NCT01296412|147203266|NON_INFERIORITY_OR_EQUIVALENCE|The sitagliptin-based treatment paradigm was to be declared non-inferior to the liraglutide-based treatment paradigm in lowering A1C at Week 26 if the upper bound of 95% confidence intervals of between group difference was less than the non-inferiority margin of 0.4%.|Difference in least squares mean|0.09|||||TWO_SIDED|95.0|-0.05|0.23|||ANCOVA|The ANCOVA model included a term for treatment paradigm and a covariate for baseline value.||||0.23|-0.05|
73828286|NCT01296412|147203267|SUPERIORITY_OR_OTHER||Difference in least squares mean|5.9|||||TWO_SIDED|95.0|0.5|11.4|||ANCOVA|The ANCOVA model included a term for treatment paradigm and a covariate for baseline value.||||11.4|0.5|
73828287|NCT01296412|147203268|SUPERIORITY_OR_OTHER||Difference in percent|-9.5|||||TWO_SIDED|95.0|-17.4|-1.5|||Miettinen & Nurminen|||||-1.5|-17.4|
73828288|NCT01296412|147203269|SUPERIORITY_OR_OTHER||Difference in percent|-4.5|||||TWO_SIDED|95.0|-12.7|3.7|||Miettinen & Nurminen|||||3.7|-12.7|
73828289|NCT02160626|147203270|OTHER|||||||0.0003|||||||ANOVA|||||||0.0003
73828290|NCT02160626|147203270|OTHER|||||||0.0001|||||||ANOVA|||||||.0001
73828291|NCT02160626|147203271|OTHER|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.||||0.0001
73828292|NCT02160626|147203271|OTHER|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.||||0.0001
73828293|NCT02160626|147203272|OTHER|||||||0.0016||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||"Secondary efficacy analyses will also be conducted based on the proportion of subjects who have at least 3 of 4 target lesions judged to be clear on the PLA (PLA=0) at Visit 8.~A separate comparison will be made between each active treatment group and the vehicle treatment group using Cochran-Mantel-Haenszel (CMH) tests stratified by site."||||0.0016
73828294|NCT02160626|147203272|OTHER|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||||||0.0004||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.0004
73828295|NCT00032591|147203273|NON_INFERIORITY_OR_EQUIVALENCE|A target of 363 patients with primary events required to discern a 32% relative drop in annual primary event rates with 90% power (from 5.5% for HQACM to 3.75% for PST) was based on a sample size of 3200 patients with 1 year of enrollment and a minimum of 2 years follow-up. Due to slower than planned enrollment, we randomized 2922 patients over 2.75 years, with a mean follow-up of 3 years.|Hazard Ratio (HR)|0.88||||0.14|||||||Log Rank|||The null hypothesis was the hazard ratio was equal to 1.||||0.14
73828296|NCT00434252|147203298|SUPERIORITY_OR_OTHER||Difference in survival rates|3.5||||0.5724||95.0|-8.7|15.7|||z-test|z-test using the standard errors computed using Greenwood's method.||||15.7|-8.7|0.5724
73828297|NCT00434252|147203299|SUPERIORITY_OR_OTHER||Difference in event rates|12.2||||0.0982||95.0|-2.3|26.6|||z-test|z-test using the standard errors computed using Greenwood's method||||26.6|-2.3|0.0982
73828298|NCT02997163|147203303|SUPERIORITY||Percent Ratio of Geometric Means|112.2|||||TWO_SIDED|90.0|80.06|157.26||||||||157.26|80.06|
73828299|NCT02997163|147203303|SUPERIORITY||Percent Ratio of Geometric Means|142.98|||||TWO_SIDED|90.0|103.03|198.42||||||||198.42|103.03|
73828300|NCT02997163|147203303|SUPERIORITY||Percent Ratio of Geometric Means|263.32|||||TWO_SIDED|90.0|187.88|369.06||||||||369.06|187.88|
73828301|NCT02997163|147203304|SUPERIORITY||Percent Ratio of Geometric Means|111.13|||||TWO_SIDED|90.0|74.4|166.01||||||||166.01|74.40|
73828302|NCT02997163|147203304|SUPERIORITY||Percent Ratio of Geometric Means|131.57|||||TWO_SIDED|90.0|89.12|194.25||||||||194.25|89.12|
73828303|NCT02997163|147203304|SUPERIORITY||Percent Ratio of Geometric Means|189.32|||||TWO_SIDED|90.0|126.74|282.8||||||||282.80|126.74|
73828304|NCT02997163|147203305|SUPERIORITY||Percent Ratio of Geometric Means|118.58|||||TWO_SIDED|90.0|83.85|167.7||||||||167.70|83.85|
73828305|NCT02997163|147203305|SUPERIORITY||Percent Ratio of Geometric Means|139.34|||||TWO_SIDED|90.0|99.53|195.06||||||||195.06|99.53|
73828306|NCT02997163|147203305|SUPERIORITY||Percent Ratio of Geometric Means|286.61|||||TWO_SIDED|90.0|202.66|405.33||||||||405.33|202.66|
73828307|NCT02997163|147203306|SUPERIORITY||Percent Ratio of Geometric Means|117.45|||||TWO_SIDED|90.0|79.74|172.99||||||||172.99|79.74|
73828308|NCT02997163|147203306|SUPERIORITY||Percent Ratio of Geometric Means|128.22|||||TWO_SIDED|90.0|88.05|186.72||||||||186.72|88.05|
73828309|NCT02997163|147203306|SUPERIORITY||Percent Ratio of Geometric Means|206.07|||||TWO_SIDED|90.0|139.91|303.51||||||||303.51|139.91|
73828310|NCT02470741|147203334|SUPERIORITY||Mean Difference (Net)|-11.85||||0.24|TWO_SIDED|95.0|-32.92|9.23|||Mixed Models Analysis|Repeated measures mixed models, with unstructured co-variance matrix.|Model generated LS Mean Differences|Null hypotheses: Letrozole is not associated with an improvement in the UFSQOL Overall Score.||9.23|-32.92|0.24
73828311|NCT01949545|147203339|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|144.43||||0.02232|TWO_SIDED|95.0|111.48|187.12|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an analysis of variance (ANOVA) of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||187.12|111.48|0.02232
73828312|NCT01949545|147203339|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|126.08||||0.1812|TWO_SIDED|95.0|94.59|168.06|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||168.06|94.59|0.1812
73828313|NCT01949545|147203340|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|151.84||||0.02137|TWO_SIDED|95.0|113.59|202.96|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||202.96|113.59|0.02137
73828314|NCT01949545|147203340|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|143.53||||0.07247|TWO_SIDED|95.0|103.28|199.45|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||199.45|103.28|0.07247
73828315|NCT01677286|147203392|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|171.0||||0.035|TWO_SIDED|95.0|14.1|328.0|||Mixed Models Analysis|degrees of freedom = 12||BNP pg/mL, baseline versus end study values||328|14.1|0.035
73828316|NCT01677286|147203393|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|0.0072||||0.34|TWO_SIDED|95.0|-0.009|0.0234|||Mixed Models Analysis|degrees of freedom = 12||Troponin I ng/mL, baseline versus end study levels.||0.0234|-0.009|0.340
73828317|NCT01677286|147203394|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|-7.39||||0.017|TWO_SIDED|95.0|-13.12|-1.67|||Mixed Models Analysis|degrees of freedom = 10||Creatinine clearance, baseline versus end study levels.||-1.67|-13.12|0.017
73828318|NCT01677286|147203395|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|0.091||||0.603|TWO_SIDED|95.0|-0.285|0.466|||Mixed Models Analysis|degrees of freedom = 10||Proteinuria (g/24 hours), baseline versus end study levels.||0.466|-0.285|0.603
73828319|NCT00427934|147203409|SUPERIORITY_OR_OTHER||Percentage Difference|-1.73||||0.79||90.0|-15.13|8.68|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1||8.68|-15.13|0.790
73828320|NCT00427934|147203409|SUPERIORITY_OR_OTHER||Percentage Difference|0.43||||0.477||90.0|-13.67|11.64|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2||11.64|-13.67|0.477
73828321|NCT00427934|147203409|SUPERIORITY_OR_OTHER||Percentage Difference|3.03||||0.37||90.0|-12.85|16.77|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||16.77|-12.85|0.370
73828322|NCT00427934|147203409|SUPERIORITY_OR_OTHER||Percentage Difference|8.66||||0.175||90.0|-7.07|22.03|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||22.03|-7.07|0.175
73828323|NCT00427934|147203410|SUPERIORITY_OR_OTHER||Percentage Difference|1.3||||0.42||90.0|-6.34|6.01|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1||6.01|-6.34|0.420
73828324|NCT00427934|147203410|SUPERIORITY_OR_OTHER||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2||7.95|-5.08|0.258
73828325|NCT00427934|147203410|SUPERIORITY_OR_OTHER||Percentage Difference|-3.46||||1||90.0|-14.39|3.42|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||3.42|-14.39|1.000
73828326|NCT00427934|147203410|SUPERIORITY_OR_OTHER||Percentage Difference|-1.3||||0.899||90.0|-13.56|7.92|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||7.92|-13.56|0.899
73828327|NCT00427934|147203410|SUPERIORITY_OR_OTHER||Percentage Difference|1.3||||0.489||90.0|-11.24|10.96|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12||10.96|-11.24|0.489
73828328|NCT00427934|147203411|SUPERIORITY_OR_OTHER||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||1.28|-13.59|1.000
73828329|NCT00427934|147203411|SUPERIORITY_OR_OTHER||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||7.95|-5.08|0.258
73828330|NCT00427934|147203411|SUPERIORITY_OR_OTHER||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12||1.28|-13.59|1.000
73828331|NCT00427934|147203412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.335||90.0|-0.79|2.99||This analysis was carried out using analysis of covariance (ANCOVA) with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||2.99|-0.79|0.335
73828332|NCT00427934|147203412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.816||90.0|-1.82|2.41||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.41|-1.82|0.816
73828333|NCT00427934|147203412|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.01||||0.996||90.0|-2.35|2.36||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||2.36|-2.35|0.996
73828334|NCT00427934|147203412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.263||90.0|-3.98|0.76||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.76|-3.98|0.263
73828335|NCT00427934|147203412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48||||0.294||90.0|-3.82|0.85||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.85|-3.82|0.294
73828336|NCT00427934|147203413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.7||90.0|-1.7|1.06||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||1.06|-1.70|0.700
73828337|NCT00427934|147203413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.799||90.0|-1.45|1.97||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||1.97|-1.45|0.799
73828338|NCT00427934|147203413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.867||90.0|-1.35|1.66||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||1.66|-1.35|0.867
73828339|NCT00427934|147203413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45||||0.167||90.0|-3.17|0.28||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.28|-3.17|0.167
73828340|NCT00427934|147203413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.966||90.0|-1.91|1.81||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||1.81|-1.91|0.966
73828341|NCT00427934|147203414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.925||90.0|-6.41|5.72||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||5.72|-6.41|0.925
73828342|NCT00427934|147203414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.26||||0.239||90.0|-12.62|2.11||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.11|-12.62|0.239
73828343|NCT00427934|147203414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.872||90.0|-6.79|8.25||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||8.25|-6.79|0.872
73828344|NCT00427934|147203414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.745||90.0|-9.91|6.65||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||6.65|-9.91|0.745
73828345|NCT00427934|147203414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.644||90.0|-10.14|5.71||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||5.71|-10.14|0.644
73828346|NCT00427934|147203415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36||||0.524||90.0|-8.49|3.77||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||3.77|-8.49|0.524
73828347|NCT00427934|147203415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.96||||0.338||90.0|-10.8|2.87||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.87|-10.80|0.338
73828348|NCT00427934|147203415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.83||90.0|-8.55|6.58||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||6.58|-8.55|0.830
73828349|NCT00427934|147203415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.68||||0.118||90.0|-15.76|0.4||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.40|-15.76|0.118
73828350|NCT00427934|147203415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||0.712||90.0|-9.73|6.18||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||6.18|-9.73|0.712
73828351|NCT00427934|147203416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.54||90.0|-0.28|0.13||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||0.13|-0.28|0.540
73828352|NCT00427934|147203416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.757||90.0|-0.28|0.19||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||0.19|-0.28|0.757
73828353|NCT00427934|147203416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.767||90.0|-0.31|0.21||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||0.21|-0.31|0.767
73828354|NCT00427934|147203416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.112||90.0|-0.52|0.01||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.01|-0.52|0.112
73828355|NCT00427934|147203416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.49||90.0|-0.42|0.17||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.17|-0.42|0.490
73828356|NCT00427934|147203417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.464||90.0|-0.19|0.07||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||0.07|-0.19|0.464
73828357|NCT00427934|147203417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.068||90.0|-0.35|-0.02||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||-0.02|-0.35|0.068
73828358|NCT00427934|147203417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.532||90.0|-0.23|0.11||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||0.11|-0.23|0.532
73828359|NCT00427934|147203417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.063||90.0|-0.41|-0.03||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||-0.03|-0.41|0.063
73828360|NCT00427934|147203417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.396||90.0|-0.36|0.12||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.12|-0.36|0.396
73828361|NCT00427934|147203418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.481||90.0|-7.36|2.96||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||2.96|-7.36|0.481
73828362|NCT00427934|147203418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.698||90.0|-4.34|6.99||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||6.99|-4.34|0.698
73828363|NCT00427934|147203418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.65||||0.233||90.0|-1.79|11.1||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||11.10|-1.79|0.233
73828364|NCT00427934|147203418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.48||||0.32||90.0|-2.29|9.25||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||9.25|-2.29|0.320
73828365|NCT00427934|147203418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.912||90.0|-5.81|6.64||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||6.64|-5.81|0.912
73828366|NCT00427934|147203419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.653||90.0|-0.31|0.18||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 1||0.18|-0.31|0.653
73828367|NCT00427934|147203419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.703||90.0|-0.41|0.26||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 2||0.26|-0.41|0.703
73828368|NCT00427934|147203419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.968||90.0|-0.37|0.39||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 4||0.39|-0.37|0.968
73828369|NCT00427934|147203419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.21||90.0|-0.72|0.1||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 8||0.10|-0.72|0.210
73828370|NCT00427934|147203419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.696||90.0|-0.53|0.33||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 12||0.33|-0.53|0.696
73828371|NCT00427934|147203421|SUPERIORITY_OR_OTHER||Percentage Difference|9.09||||0.155||90.0|-6.16|21.83||p-value (one-sided) was based on Barnard exact test if more than 20% of expected cell counts were \< 5 otherwise Pearson chi-square test.|Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|||21.83|-6.16|0.155
73828372|NCT00427934|147203427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.698||90.0|-1.87|3.01||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||3.01|-1.87|0.698
73828373|NCT00427934|147203427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68||||0.344||90.0|-4.62|1.26||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||1.26|-4.62|0.344
73828374|NCT00427934|147203428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.734||90.0|-2.71|4.11||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||4.11|-2.71|0.734
73828375|NCT00427934|147203428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.818||90.0|-3.5|4.62||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||4.62|-3.50|0.818
73828376|NCT00427934|147203429|SUPERIORITY_OR_OTHER|||||||0.649||95.0|||||Fisher Exact|||||||0.649
73828377|NCT00427934|147203430|SUPERIORITY_OR_OTHER|||||||0.9826||95.0|||||Log Rank|||||||0.9826
73828378|NCT04539275|147203447|SUPERIORITY||Risk Difference (RD)|-0.01||||1|TWO_SIDED|95.0|-0.15|0.14|||Fisher Exact|||||0.14|-0.15|1.00
73828379|NCT04539275|147203448|SUPERIORITY||Improvement Rate Ratio|1.08||||0.749|TWO_SIDED|95.0|0.65|1.78|||Log Rank|||||1.78|0.65|0.749
73828380|NCT04539275|147203449|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.943|TWO_SIDED|95.0|0.21|4.23|||Log Rank|||||4.23|0.21|0.943
73828381|NCT04539275|147203450|SUPERIORITY||Risk Difference (RD)|-0.08||||0.4014|TWO_SIDED|95.0|-0.25|0.1|||Chi-squared|||||0.10|-0.25|0.4014
73828382|NCT04539275|147203451|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.3762|TWO_SIDED|95.0|0.18|1.96|||Log Rank|||||1.96|0.18|0.3762
73828383|NCT04539275|147203452|SUPERIORITY||Risk Difference (RD)|-0.04||||0.6867|TWO_SIDED|95.0|-0.17|0.09|||Fisher Exact|||||0.09|-0.17|0.6867
73828384|NCT04539275|147203453|SUPERIORITY||Improvement Rate Ratio|1.11||||0.6494|TWO_SIDED|95.0|0.68|1.83|||Log Rank|||||1.83|0.68|0.6494
73828385|NCT04539275|147203454|SUPERIORITY||Improvement Rate Ratio|0.98||||0.9338|TWO_SIDED|95.0|0.59|1.63|||Log Rank|||||1.63|0.59|0.9338
73828386|NCT04539275|147203458|SUPERIORITY||Improvement Rate Ratio|1.14||||0.5682|TWO_SIDED|95.0|0.7|1.86|||Log Rank|||||1.86|0.70|0.5682
73828387|NCT04539275|147203460|SUPERIORITY||Median Difference (Final Values)|0.0||||0.8642|TWO_SIDED|95.0|-2.3|2.3|||Wilcoxon (Mann-Whitney)|||||2.3|-2.3|0.8642
73828388|NCT01373164|147203463|SUPERIORITY|The planned primary analysis for this study utilized a Bayesian exponential-likelihood model, incorporating historical overall survival (OS) data from 2 studies (Oettle et al. 2005; Saif et al. 2009). The primary analysis was performed using strong borrowing from the historical data. The model was estimated to borrow approximately 37 events from the historical studies.|Hazard Ratio (HR)|0.794|||||TWO_SIDED|95.0|0.59|1.085|||Bayesian Analysis|Primary comparison was to be considered successful if there was at least 0.85 posterior probability that the hazard ratio (HR) for OS of LY+Gem is \<1.|This is a Credible Interval estimated from the Bayesian analysis.|||1.085|0.590|
73828389|NCT01799941|147203476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
73828390|NCT01799941|147203476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||one-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
73828391|NCT01799941|147203476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
73828392|NCT01799941|147203476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
73828393|NCT01799941|147203476|SUPERIORITY_OR_OTHER||Analysis of covariance (ANCOVA)|0.04|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|-1.37|1.45|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||1.45|-1.37|
73828394|NCT01799941|147203476|SUPERIORITY_OR_OTHER||ANCOVA|1.11|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-0.46|2.68|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||2.68|-0.46|
73828395|NCT01799941|147203476|SUPERIORITY_OR_OTHER||ANCOVA|1.15|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.39|2.69|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||2.69|-0.39|
73828396|NCT01799941|147203477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
73828397|NCT01799941|147203477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
73828398|NCT01799941|147203477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
73828399|NCT01799941|147203477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
73828400|NCT01799941|147203478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
73828401|NCT01799941|147203478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
73828402|NCT01799941|147203478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
73828403|NCT01799941|147203478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 assessment||||<0.0001
73828404|NCT01799941|147203478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
73828405|NCT01799941|147203478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
73828406|NCT01799941|147203478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
73828407|NCT01799941|147203478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
73828408|NCT01799941|147203480|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.425|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.407|0.445|||Mixed Effects Poisson Regreesion Model||Number of observations = 854, Number of participants = 298|Day 30 assessment||0.445|0.407|<0.0001
73828409|NCT01799941|147203480|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.277|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.262|0.293|||Mixed Effects Poisson Regression Model||Number of observations = 854, Number of participants = 298|Day 90 assessment||0.293|0.262|<0.0001
73828410|NCT01799941|147203480|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.5|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.469|0.534|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 30 assessment||0.534|0.469|<0.0001
73828411|NCT01799941|147203480|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.323|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.299|0.349|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 90 assessment||0.349|0.299|<0.0001
73828412|NCT01799941|147203480|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.351|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.323|0.383|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 30 assessment||0.383|0.323|<0.0001
73828413|NCT01799941|147203480|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.255|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.231|0.282|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 90 assessment||0.282|0.231|<0.0001
73828414|NCT01799941|147203480|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.387|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|0.352|0.425|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 30 assessment||0.425|0.352|<0.0001
73828415|NCT01799941|147203480|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.215|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.189|0.245|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 90 assessment||0.245|0.189|<0.0001
73828416|NCT01799941|147203483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
73828417|NCT01799941|147203483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
73828418|NCT01799941|147203483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
73828419|NCT01799941|147203483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
73828420|NCT02419807|147203553|EQUIVALENCE|Equivalence is defined as the difference in the proportions of nodes flagged between the Tc and ICG methods falling within an interval (-δ, +δ), where δ is taken to be 5%.|Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|0.036|0.151||||||||0.151|0.036|
73828421|NCT02932943|147203569|SUPERIORITY||Least Squares Mean Difference|0.3||||0.6482|TWO_SIDED|95.0|-1.07|1.72|||Mixed Model Repeated Measures (MMRM)|||||1.72|-1.07|0.6482
73828422|NCT02932943|147203570|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.559|TWO_SIDED|95.0|-1.61|0.87|||Mixed Model Repeated Measures (MMRM)|||||0.87|-1.61|0.5590
73828423|NCT02932943|147203571|SUPERIORITY||Least Squares Mean Difference|0.2||||0.8131|TWO_SIDED|95.0|-1.53|1.95|||Mixed Model Repeated Measures (MMRM)|||||1.95|-1.53|0.8131
73828424|NCT02932943|147203572|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.6108|TWO_SIDED|95.0|-2.05|1.21|||Mixed Model Repeated Measures (MMRM)|||||1.21|-2.05|0.6108
73828425|NCT01663623|147203589|OTHER||Hazard Ratio (HR)|1.07||||0.884|TWO_SIDED|95.0|0.44|2.59||Cox proportional Hazards (Wald Chi Square)|Cox Proportional Hazards model|Analysis was adjusted for ANCA type, disease stage at induction and induction regimen|Analysis performed using a Cox Proportional Hazards model with covariates treatment group, Actual ANCA type, Actual disease stage at induction and Actual induction regimen.|||2.59|0.44|0.884
73828426|NCT02330341|147203602|SUPERIORITY|||||||0.38||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on Artemisia Dracunculus group||||0.380
73828427|NCT02330341|147203602|SUPERIORITY|||||||0.695|||||||Wilcoxon (Mann-Whitney)|The threshold for statistical significance was p=0.05||Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on placebo group||||0.695
73828428|NCT02330341|147203603|SUPERIORITY|||||||0.11||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Artemisia Dracunculus group||||0.110
73828429|NCT02330341|147203603|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group||||0.910
73828430|NCT02330341|147203604|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on Artemisia Dracunculus group||||0.010
73828431|NCT02330341|147203604|SUPERIORITY|||||||0.938||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on placebo group||||0.938
73828432|NCT02330341|147203605|SUPERIORITY|||||||0.733||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Artemisia Dracunculus group||||0.733
73828433|NCT02330341|147203605|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group||||1.0
73828434|NCT02330341|147203606|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Artemisia Dracunculus group||||0.03
73828435|NCT02330341|147203606|SUPERIORITY|||||||0.9||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group||||0.900
73828436|NCT02330341|147203607|SUPERIORITY|||||||0.519||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Artemisia Dracunculus group||||0.519
73828437|NCT02330341|147203607|SUPERIORITY|||||||0.922||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group||||0.922
73828438|NCT02330341|147203608|SUPERIORITY|||||||0.605||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of weight on Artemisia Dracunculus group||||0.605
73828439|NCT02330341|147203608|SUPERIORITY|||||||0.105||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of weight on placebo group||||0.105
73828440|NCT02330341|147203609|SUPERIORITY|||||||0.687||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on Artemisia Dracunculus group||||0.687
73828441|NCT02330341|147203609|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group||||0.021
73828442|NCT02330341|147203610|SUPERIORITY|||||||0.339||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Artemisia Dracunculus group||||0.339
73828443|NCT02330341|147203610|SUPERIORITY|||||||0.246||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group||||0.246
73828444|NCT02330341|147203611|SUPERIORITY|||||||0.775||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on Artemisia Dracunculus group||||0.775
73828445|NCT02330341|147203611|SUPERIORITY|||||||0.195||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group||||0.195
73828446|NCT02330341|147203612|SUPERIORITY|||||||0.04||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on Artemisia Dracunculus group||||0.040
73828447|NCT02330341|147203612|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group||||1.000
73828448|NCT02330341|147203613|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on Artemisia Dracunculus group||||0.021
73828449|NCT02330341|147203613|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group||||0.080
73828450|NCT02330341|147203614|SUPERIORITY|||||||0.465||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on Artemisia Dracunculus group||||0.465
73828451|NCT02330341|147203614|SUPERIORITY|||||||0.574||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on placebo group||||0.574
73828452|NCT02330341|147203615|SUPERIORITY|||||||0.48||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on Artemisia Dracunculus group||||0.480
73828453|NCT02330341|147203615|SUPERIORITY|||||||0.383||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group||||0.383
73828454|NCT02330341|147203616|SUPERIORITY|||||||0.034||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on Artemisia Dracunculus group||||0.034
73828455|NCT02330341|147203616|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group||||0.080
73828456|NCT02330341|147203617|SUPERIORITY|||||||0.017||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Artemisia Dracunculus group||||0.017
73828457|NCT02330341|147203617|SUPERIORITY|||||||0.082||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group||||0.082
73828458|NCT02330341|147203618|SUPERIORITY|||||||0.17||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Artemisia Dracunculus group||||0.170
73828459|NCT02330341|147203618|SUPERIORITY|||||||0.199||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure placebo group||||0.199
73828460|NCT01462942|147203619|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.125|||<|0.0001|TWO_SIDED|95.0|0.09|0.16|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.160|0.090|<0.0001
73828461|NCT01462942|147203619|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.069||||0.0001|TWO_SIDED|95.0|0.034|0.105|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.105|0.034|0.0001
73828462|NCT01462942|147203620|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085|||<|0.0001|TWO_SIDED|95.0|0.051|0.119|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.119|0.051|<0.0001
73828463|NCT01462942|147203620|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.053||||0.0022|TWO_SIDED|95.0|0.019|0.087|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.087|0.019|0.0022
73828464|NCT01462942|147203621|SUPERIORITY_OR_OTHER||Least squares mean difference|1.293|||<|0.0001|TWO_SIDED|95.0|0.728|1.859|||Mixed Models Analysis|Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||1.859|0.728|<0.0001
73828465|NCT01462942|147203621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.162|||<|0.0001|TWO_SIDED|95.0|0.593|1.73|||Mixed Models Analysis|||Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||1.730|0.593|<0.0001
73828466|NCT01462942|147203622|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.653||||0.598|TWO_SIDED|95.0|-3.082|1.776|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||1.776|-3.082|0.5980
73828467|NCT01462942|147203622|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.828||||0.1406|TWO_SIDED|95.0|-4.259|0.604|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||0.604|-4.259|0.1406
73828468|NCT01027845|147203623|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 1.05 µg/mL with 95% CI = (1.00 to 1.10).|GMC ratio|0.16|||||TWO_SIDED|95.0|0.14|0.18||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 1."||0.18|0.14|
73828469|NCT01027845|147203623|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1106 in the 105553 10Pn Group; GMC= 1.45 µg/mL with 95% CI = (1.38 to 1.53).|GMC ratio|0.22|||||TWO_SIDED|95.0|0.2|0.25||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 4."||0.25|0.2|
73828470|NCT01027845|147203623|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.70 µg/mL with 95% CI = (1.62 to 1.78).|GMC ratio|0.26|||||TWO_SIDED|95.0|0.23|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 5."||0.29|0.23|
73828471|NCT01027845|147203623|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 0.33 µg/mL with 95% CI = (0.30 to 0.36).|GMC ratio|0.19|||||TWO_SIDED|95.0|0.16|0.23||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 6B."||0.23|0.16|
73828472|NCT01027845|147203623|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1107 in the 105553 10Pn Group; GMC= 1.72 µg/mL with 95% CI = (1.64 to 1.80).|GMC ratio|0.28|||||TWO_SIDED|95.0|0.25|0.31||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 7F."||0.31|0.25|
73828473|NCT01027845|147203623|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1103 in the 105553 10Pn Group; GMC= 1.32 µg/mL with 95% CI = (1.25 to 1.38).|GMC ratio|0.24|||||TWO_SIDED|95.0|0.22|0.27||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 9V."||0.27|0.22|
73828474|NCT01027845|147203623|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 2.90 µg/mL with 95% CI = (2.75 to 3.05).|GMC ratio|0.29|||||TWO_SIDED|95.0|0.25|0.33||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 14."||0.33|0.25|
73828475|NCT01027845|147203623|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 1.66 µg/mL with 95% CI = (1.56 to 1.77).|GMC ratio|0.1|||||TWO_SIDED|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 18C."||0.12|0.09|
73828476|NCT01027845|147203623|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.84 µg/mL with 95% CI = (1.71 to 1.98).|GMC ratio|0.11|||||TWO_SIDED|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 19F."||0.12|0.09|
73828477|NCT01027845|147203623|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 0.53 µg/mL with 95% CI = (0.50 to 0.57).|GMC ratio|0.25|||||TWO_SIDED|95.0|0.21|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 23F."||0.29|0.21|
73828478|NCT00486044|147203647|SUPERIORITY_OR_OTHER|||||||0.966||95.0|||||Kruskal-Wallis|||||||0.966
73828479|NCT00486044|147203648|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||||||0.015
73828480|NCT00486044|147203649|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Kruskal-Wallis|||||||0.113
73828481|NCT00486044|147203650|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Kruskal-Wallis|||||||0.210
73828482|NCT02449434|147203652|OTHER|Using the presence or absence of severe erosive wear as the dependent variable, the unadjusted, sex-and-age- adjusted and fully adjusted associations of the included variables with erosive tooth wear were estimated using unconditional binary logistic regression and reported using odds ratios (OR).|Odds Ratio (OR)|2.25|||<|0.05|TWO_SIDED|95.0||||Only results from fully adjusted regression models will be deemed as significant|Regression, Logistic|Unconditional binary logistic regression and reported using odds ratios and 95% confidence intervals||A minimum sample size of 490 participants (245 in each group) was needed. This calculation assumed the proportion of adults with high dietary acid intake (3+ times/day) was 55% among cases and 40% among controls (expected odds ratio of 2.25), case- control ratio of 1-to-1, 90% statistical power and 95% significance level.||||<0.05
73828483|NCT03154086|147203752|OTHER||Ratio|0.8||||0.204|TWO_SIDED|90.0|0.594|1.077|||ANOVA|||||1.077|0.5940|0.204
73828484|NCT03154086|147203753|OTHER||Ratio|0.7325||||0.118|TWO_SIDED|90.0|0.5267|1.019|||ANOVA|||||1.019|0.5267|0.118
73828485|NCT03154086|147203754|OTHER||Ratio|0.6502||||0.157|TWO_SIDED|90.0|0.3876|1.091|||ANOVA|||||1.091|0.3876|0.157
73828486|NCT04465422|147203765|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|1.65|5.55|||Mixed Models Analysis|||Statistical Anaiysis 1 is according to Occupational Performance History Interview - II (OPHI-II) total score.||5.55|1.65|<0.001
73828487|NCT04465422|147203765|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.53||0.019|TWO_SIDED|95.0|0.23|2.37|||Mixed Models Analysis|||Statistical Analysis 2 is based on Occupational Identity(range 11\~44；higher scores indicates better performance), a sub-domain of OPHI-II. The Occupational Identity scale is designed to measure the degree to which a client has internalized a positive occupational identity (i.e., has values, interests, and confidence; sees self in various occupational roles; has an image of the kind of life desired)||2.37|0.23|0.019
73828488|NCT04465422|147203765|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.43||0.006|TWO_SIDED|95.0|0.38|2.11|||Mixed Models Analysis|||Statistical Analysis 3 is based on Occupational Competence(range 9\~36；higher scores indicate better performance), a sub-domain of OPHI-II. The Occupational Competence scale is designed to measure the degree to which a client is able to sustain a pattern of occupational behavior that is productive and satisfying.||2.11|0.38|0.006
73828489|NCT04465422|147203765|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.38||0.136|TWO_SIDED|95.0|-0.19|1.35|||Mixed Models Analysis|||Statistical Analysis 4 is based on Occupational Behavior Settings(range 9\~36；higher scores indicate greater performance), a sub-domain of OPHI-II. The Occupational Behavior Settings scale addresses the impact of the environment on the person's occupational life.||1.35|-0.19|0.136
73828490|NCT04465422|147203766|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.53||0.592|TWO_SIDED|95.0|-3.9|2.25|||Mixed Models Analysis|||Statistical Analysis 1 is based on Lawton Instrumental Activities Daily Living (range 0\~23；the higher scores indicate greater performance) total scores.||2.25|-3.90|0.592
73828491|NCT04465422|147203766|SUPERIORITY||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|2.37||0.302|TWO_SIDED|95.0|-2.29|7.23|||Mixed Models Analysis|||Statistical Analysis 2 is based on Comprehensive Occupational Therapy Evaluation Scale (range 20\~100；the higher scores indicate greater performance) total scores.||7.23|-2.29|0.302
73828492|NCT04465422|147203766|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|3.25||0.931|TWO_SIDED|95.0|-6.25|6.82|||Mixed Models Analysis|||Statistical Analysis 3 is based on Personal and Social Performance scale (range 1\~100；the higher scores indicate greater performance) total scores.||6.82|-6.25|0.931
73828493|NCT04465422|147203766|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.85||0.981|TWO_SIDED|95.0|-1.73|1.69|||Mixed Models Analysis|||Statistical Analysis 4 is based on Canadian Occupational Performance Measure (range 1\~10；the higher scores indicate greater performance) total scores.||1.69|-1.73|0.981
73828494|NCT00062166|147203790|NON_INFERIORITY|Time dependent risk for requiring an intervention for pancreatic neuroendocrine tumors (PNET), among 63 patients with PNETs with diameter \>1.2 and \<3 cm, and a known position of germline VHL pathogenic variant (n=63). Comparison between exon 3 vs exon 1 and 2.|Hazard Ratio (HR)|3.3||||0.02|TWO_SIDED|95.0|1.2|9.1|||Regression, Cox|||||9.1|1.2|0.02
73828495|NCT00833755|147203794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274|||||||Kruskal-Wallis|||||||0.274
73828496|NCT00833755|147203795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552|||||||Kruskal-Wallis|||||||0.552
73828497|NCT00833755|147203796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
73828498|NCT02439164|147203797|SUPERIORITY||Mean Difference (Net)|23.51|||<|0.01|TWO_SIDED|95.0|14.16|32.87|||t-test, 2 sided|bonferroni correction was used for post hoc analysis, P value less than 0.05 indicated statistical significance.|this described the difference during midazolam sedation between the glioma and control group without dividing into subgroups.||Oneway Analysis of Variance (ANOVA) was used to test the difference among hands in a certain time point. General linear model for repeated measures ANOVA was used to analyze the time difference of test before and after drug administration,|32.87|14.16|<0.01
73828499|NCT02475369|147203820|SUPERIORITY|||||||0.271|||||||Wilcoxon (Mann-Whitney)|||||||0.271
73828500|NCT02475369|147203821|OTHER|In order to calculate a correlation between baseline fecal elastase-1 and total CeD-GSRS score on PES treatment vs. placebo treatment, we calculated a Spearman's rank correlation coefficient between the two independent variables.||||||0.995|||||||Spearman rank coefficient|||||||0.995
73828501|NCT02475369|147203822|OTHER|In order to evaluate the estimated difference of the effect of Pancreatic Enzyme Supplement versus Placebo for the Celiac Symptom Index (CSI) scores, we used a linear mixed effects model with the nlme package.||||||0.08|||||||Linear Mixed Effects model|||||||0.08
73828502|NCT02139540|147203844|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||The primary outcome (HDRS-21) was analyzed with a repeated-measures mixed effects linear model using restricted maximum likelihood estimation. To adjust for the observed carryover effect, the model included a randomization group term and a three-way interaction (treatment × time × randomization group)||||<0.05
73828503|NCT02139540|147203845|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
73828504|NCT03880474|147203894|OTHER||Relative Risk|1.52||||0.1146|TWO_SIDED|95.0|0.9|2.55|||Log Binominal Model|||||2.55|0.90|0.1146
73828505|NCT03880474|147203894|OTHER||Relative Risk|1.52||||0.1146|TWO_SIDED|95.0|0.9|2.55|||Poisson Model with Robust Variance|||||2.55|0.90|0.1146
73828506|NCT03880474|147203895|OTHER||Relative Risk|1.0||||1|TWO_SIDED|95.0|0.86|1.15|||Log Binomial Model|||The Analysis concerns the Incidence of Influenza-like Illness (ILI)||1.15|0.86|1.0000
73828507|NCT03880474|147203895|OTHER||Relative Risk|1.0||||0.9799|TWO_SIDED|95.0|0.86|1.15|||Poisson Model with Robust Variance|||The Analysis concerns the Incidence of Influenza-like Illness (ILI)||1.15|0.86|0.9799
73828508|NCT03880474|147203897|OTHER||Least Squares Mean Difference|-287.1||||0.3284|TWO_SIDED|95.0|-872.75|298.59|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Day 28||298.59|-872.75|0.3284
73828509|NCT03880474|147203897|OTHER||Least Squares Mean Difference|-13.39||||0.8468|TWO_SIDED|95.0|-152.26|125.47|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Week26||125.47|-152.26|0.8468
73828510|NCT03880474|147203897|OTHER||Least Squares Mean Difference|-465.7||||0.5087|TWO_SIDED|95.0|-1875.21|943.75|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Day 28||943.75|-1875.21|0.5087
73828511|NCT03880474|147203897|OTHER||Least Squares Mean Difference|-83.68||||0.7509|TWO_SIDED|95.0|-611.67|444.32|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Week 26||444.32|-611.67|0.7509
73828512|NCT03880474|147203897|OTHER||Least Squares Mean Difference|-81.17||||0.3398|TWO_SIDED|95.0|-250.72|88.39|||ANOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Day 28||88.39|-250.72|0.3398
73828513|NCT03880474|147203897|OTHER||Least Squares Mean Difference|26.15||||0.4154|TWO_SIDED|95.0|-37.95|90.26|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Week 26||90.26|-37.95|0.4154
73828514|NCT03880474|147203897|OTHER||Least Squares Mean Difference|22.84||||0.7193|TWO_SIDED|95.0|-104.5|150.18|||ANCOVA|||Titers of neutralizing antibodies against Influenza B/ Victoria at Day 28||150.18|-104.50|0.7193
73828515|NCT03880474|147203897|OTHER||Least Squares Mean Difference|52.38||||0.1496|TWO_SIDED|95.0|-19.59|124.35|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/ Victoria at Week 26||124.35|-19.59|0.1496
73828516|NCT03880474|147203897|OTHER||Least Squares Mean Difference|-16.76||||0.9044|TWO_SIDED|95.0|-296.57|263.06|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Day 28||263.06|-296.57|0.9044
73828517|NCT03880474|147203897|OTHER||Least Squares Mean Difference|38.64||||0.4198|TWO_SIDED|95.0|-56.97|134.24|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Week 26||134.24|-56.97|0.4198
73828518|NCT03880474|147203898|OTHER||Hazard Ratio (HR)|1.08||||0.4159|TWO_SIDED|95.0|0.9|1.28|||Regression, Cox|||||1.28|0.90|0.4159
73828519|NCT03880474|147203899|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.99||||0.955|TWO_SIDED|95.0|0.83|1.19|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Feeling Hot (AUC)||1.19|0.83|0.9550
73828520|NCT03880474|147203899|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.0||||0.8933|TWO_SIDED|95.0|1.0|1.0|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Temperature (AUC)||1|1|0.8933
73828521|NCT03880474|147203899|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.87||||0.2156|TWO_SIDED|95.0|0.7|1.09|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Cough (AUC)||1.09|0.7|0.2156
73828522|NCT03880474|147203899|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.88||||0.2216|TWO_SIDED|95.0|0.71|1.1|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Sore Throat AUC||1.10|0.71|0.2216
73828523|NCT03880474|147203899|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.87||||0.2306|TWO_SIDED|95.0|0.69|1.09|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Blocked Nose AUC||1.09|0.69|0.2306
73828524|NCT03880474|147203899|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.99||||0.8038|TWO_SIDED|95.0|0.97|1.13|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Chest Pain AUC||1.13|0.97|0.8038
73828525|NCT03880474|147203899|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.01||||0.9319|TWO_SIDED|95.0|0.84|1.21|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Muscle Pain AUC||1.21|0.84|0.9319
73828526|NCT03880474|147203899|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.01||||0.8399|TWO_SIDED|95.0|0.86|1.19|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Shortness of Breath AUC||1.19|0.86|0.8399
73828527|NCT03880474|147203900|OTHER||Least Squares Mean Difference|743.78||||0|TWO_SIDED|95.0|443.71|1043.84|||ANCOVA|||Statistical analysis was performed for Total(NP+M) (SFU/10\^6 PBMC) at Day 28 Nucleoprotein = NP, matrix1 = M1||1043.84|443.71|0
73828528|NCT03880474|147203900|OTHER||Least Squares Mean Difference|177.1||||0.0673|TWO_SIDED|95.0|-13.14|367.33|||ANCOVA|||Statistical analysis was performed for Total(NP+M) (SFU/10\^6 PBMC) at Week 26 Nucleoprotein = NP, matrix1 = M1||367.33|-13.14|0.0673
73828529|NCT00921024|147203901|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.8|||||TWO_SIDED|||||||||||||
73828530|NCT00921024|147203902|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.1|||||TWO_SIDED|||||||||||||
73828531|NCT02807259|147203945|EQUIVALENCE|Power calculations did not account for stratification used in the randomisation or include adjustment for baseline levels of the outcome, since the correlation over time was not known. Results suggested that the trial had \>80% power to detect a risk ratio of 0.77, if the coefficient of between-cluster variation was between 0.15 and 0.25.|Odds Ratio (OR)|1.47||||0.298|TWO_SIDED|95.0|0.71|3.01|||Mixed Models Analysis|||Power calculations were conducted assuming an IPV prevalence (past 12 months) of 47% and consistent condom use (past 12 months) of 38% based on initial assessments. The power calculation was performed by analysing simulated data from 800 women, distributed across clusters using empirical data with a range in variance across cluster-level proportions of IPV (15% to 25% of the total variation) and a narrow range of effect sizes (risk ratio= 0.75-0.80).||3.01|0.71|0.298
73828532|NCT02807259|147203946|OTHER||Odds Ratio (OR)|1.38||||0.378|TWO_SIDED|95.0|0.68|2.81|||Mixed Models Analysis|||||2.81|0.68|0.378
73828533|NCT02807259|147203947|OTHER||Odds Ratio (OR)|0.93||||0.748|TWO_SIDED|95.0|0.58|1.47|||Mixed Models Analysis|||||1.47|0.58|0.748
73828534|NCT02807259|147203948|OTHER||Odds Ratio (OR)|0.62||||0.025|TWO_SIDED|95.0|0.4|0.94|||Mixed Models Analysis|||||0.94|0.4|0.025
73828535|NCT02807259|147203949|OTHER||Odds Ratio (OR)|2.07||||0.372|TWO_SIDED|95.0|0.42|10.26|||Mixed Models Analysis|||||10.26|0.42|0.372
73828536|NCT02807259|147203950|OTHER||Odds Ratio (OR)|0.96||||0.845|TWO_SIDED|95.0|0.61|1.5|||Mixed Models Analysis|||||1.50|0.61|0.845
73828537|NCT02807259|147203951|OTHER||Odds Ratio (OR)|1.69||||0.042|TWO_SIDED|95.0|1.02|2.82|||Mixed Models Analysis|||||2.82|1.02|0.042
73828538|NCT00737178|147203965|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<.01
73828539|NCT00737178|147203967|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Chi-squared|||||||0.24
73828540|NCT00485836|147203975|SUPERIORITY_OR_OTHER||Difference in Least Squares means|11.5|||<|0.0001||95.0|7.7|15.3||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||15.3|7.7|<0.0001
73828541|NCT00485836|147203975|SUPERIORITY_OR_OTHER||Difference in Least Squares means|13.8|||<|0.0001||95.0|10.3|17.4||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||17.4|10.3|<0.0001
73828542|NCT00485836|147203976|SUPERIORITY_OR_OTHER||Difference in percentage|29.3|||<|0.0001||95.0|18.8|39.7|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||39.7|18.8|<0.0001
73828543|NCT00485836|147203976|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001||95.0|19.6|40.9|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||40.9|19.6|<0.0001
73828544|NCT00485836|147203977|SUPERIORITY_OR_OTHER||Difference in percentage|11.3||||0.0019||95.0|4.3|18.2|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||18.2|4.3|0.0019
73828545|NCT00485836|147203977|SUPERIORITY_OR_OTHER||Difference in percentage|13.6|||<|0.0001||95.0|7.2|20.1|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||20.1|7.2|<0.0001
73828546|NCT00485836|147203978|SUPERIORITY_OR_OTHER||Difference in percentage|51.9|||<|0.0001||95.0|41.6|62.3|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||62.3|41.6|<0.0001
73828547|NCT00485836|147203978|SUPERIORITY_OR_OTHER||Difference in percentage|54.0|||<|0.0001||95.0|44.0|64.1|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||64.1|44.0|<0.0001
73828548|NCT00485836|147203979|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-272.2|||<|0.0001||95.0|-329.9|-214.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-214.5|-329.9|<0.0001
73828549|NCT00485836|147203979|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-283.8|||<|0.0001||95.0|-337.8|-229.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-229.8|-337.8|<0.0001
73828550|NCT00485836|147203980|SUPERIORITY_OR_OTHER||Difference in Least Squares means|5.8||||0.0019||95.0|2.1|9.4|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||9.4|2.1|0.0019
73828551|NCT00485836|147203980|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.9||||0.0099||95.0|1.2|8.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||8.6|1.2|0.0099
73828552|NCT00485836|147203981|SUPERIORITY_OR_OTHER||Difference in Least Squares means|6.3||||0.0002||95.0|3.1|9.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||9.5|3.1|0.0002
73828553|NCT00485836|147203981|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.1||||0.0199||95.0|0.7|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||7.6|0.7|0.0199
73828554|NCT01258374|147203985|OTHER||||||<|0.01||||||The PK paramaters reported as geometric means, were calculated using noncompartmental modelinf techniques (WinNolin; Pharsight Corporation, Mountain View, CA)|Noncompartmental modeling techniques||||The pharmacokinetic parameters calculated for DRV, RTV and RAL were trough plasma concentration (C trough), defined as the concentration at 24 or 12 h after observed dose, the maximum observed plasma concentration (C max), the area under the plasma concentration-time curve from 0 to 24 H (AUC 0-24) or 0 to 12 h (AUC 0-12) and the elimination half-life (t1/2). AUC and t1/2 were calculated using non using noncompartmental modeling techniques (WinNolin; Pharsight Corporation, Mountain View, CA). All of these PK parameters are reported as geometric means.|||<0.01
73828555|NCT01125930|147204001|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.93
73828556|NCT01125930|147204002|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.79
73828557|NCT01125930|147204003|SUPERIORITY_OR_OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.94
73828558|NCT01125930|147204003|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.57
73828559|NCT01125930|147204003|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.66
73828560|NCT01125930|147204003|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.38
73828561|NCT01125930|147204003|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.24
73828562|NCT01125930|147204004|SUPERIORITY_OR_OTHER|||||||0.87|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess photodamage.||||0.87
73828563|NCT01125930|147204005|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea.||||1.00
73828564|NCT01125930|147204005|SUPERIORITY_OR_OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||0.62
73828565|NCT01125930|147204005|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||1.00
73828566|NCT01125930|147204005|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||1.00
73828567|NCT01125930|147204005|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||0.45
73828568|NCT01125930|147204006|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
73828569|NCT01125930|147204006|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
73828570|NCT01125930|147204006|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
73828571|NCT01125930|147204006|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
73828572|NCT01125930|147204006|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||1.00
73828573|NCT01125930|147204007|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||1.00
73828574|NCT01125930|147204007|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.41
73828575|NCT01125930|147204007|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.66
73828576|NCT01125930|147204007|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.92
73828577|NCT01125930|147204007|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.80
73828578|NCT01125930|147204008|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TAC1 at Week 24 visit were made using fold change data.||||0.003
73828579|NCT01125930|147204008|SUPERIORITY_OR_OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCR4 at Week 24 visit were made using fold change data.||||0.35
73828580|NCT01125930|147204008|SUPERIORITY_OR_OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCL12 at Week 24 visit were made using fold change data.||||0.68
73828581|NCT01125930|147204008|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TNFa at Week 24 visit were made using fold change data.||||0.76
73828582|NCT01125930|147204009|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-1 at Week 24 visit were made using fold change data.||||1.00
73828583|NCT01125930|147204009|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-3 at Week 24 visit were made using fold change data.||||0.25
73828584|NCT01125930|147204009|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-1 at Week 24 visit were made using fold change data.||||0.41
73828585|NCT01125930|147204009|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-3 at Week 24 visit were made using fold change data.||||0.02
73828586|NCT01125930|147204009|SUPERIORITY_OR_OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-9 at Week 24 visit were made using fold change data.||||0.61
73828587|NCT01125930|147204010|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||1.00
73828588|NCT01125930|147204010|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.44
73828589|NCT01125930|147204010|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.41
73828590|NCT01125930|147204010|SUPERIORITY_OR_OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.94
73828591|NCT01125930|147204011|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.15
73828592|NCT01125930|147204012|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.13
73828593|NCT01125930|147204013|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Group comparison at Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||1.00
73828594|NCT01125930|147204014|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.75
73828595|NCT01125930|147204015|SUPERIORITY_OR_OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.68
73828596|NCT01125930|147204016|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.77
73828597|NCT01125930|147204017|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.41
73828598|NCT01125930|147204017|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||1.00
73828599|NCT01125930|147204017|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.96
73828600|NCT01125930|147204017|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.91
73828601|NCT01125930|147204018|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
73828602|NCT01125930|147204018|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
73828603|NCT01125930|147204018|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.15
73828604|NCT01125930|147204018|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
73828605|NCT01125930|147204019|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.54
73828606|NCT01125930|147204019|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.06
73828607|NCT01125930|147204019|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.02
73828608|NCT01125930|147204019|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.09
73828609|NCT01125930|147204020|SUPERIORITY_OR_OTHER|||||||0.18|||||||Fisher Exact|||Group comparison at Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.18
73828610|NCT01125930|147204020|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||Group comparison at Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.70
73828611|NCT01125930|147204020|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||Group comparison at Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.70
73828612|NCT01125930|147204020|SUPERIORITY_OR_OTHER|||||||0.35|||||||Fisher Exact|||Group comparison at Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.35
73828613|NCT01125930|147204021|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.80
73828614|NCT01125930|147204021|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.31
73828615|NCT01125930|147204021|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.25
73828616|NCT01125930|147204021|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.46
73828617|NCT01125930|147204022|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.41
73828618|NCT01125930|147204022|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.05
73828619|NCT01125930|147204022|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.16
73828620|NCT01125930|147204022|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.14
73828621|NCT01125930|147204023|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.36
73828622|NCT01125930|147204023|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.88
73828623|NCT01125930|147204023|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.18
73828624|NCT01125930|147204023|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.17
73828625|NCT01125930|147204024|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.21
73828626|NCT01125930|147204024|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||<0.01
73828627|NCT01125930|147204024|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.04
73828628|NCT01125930|147204024|SUPERIORITY_OR_OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.10
73828629|NCT01125930|147204025|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||1.00
73828630|NCT01125930|147204025|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.02
73828631|NCT01125930|147204025|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.08
73828632|NCT01125930|147204025|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.15
73828633|NCT01125930|147204026|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.67
73828634|NCT01125930|147204026|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.18
73828635|NCT01125930|147204026|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 21 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.02
73828636|NCT01125930|147204026|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.42
73828637|NCT03098979|147204027|SUPERIORITY|||||||0.5183||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques.||||||0.5183
73828638|NCT03098979|147204027|SUPERIORITY|||||||0.33||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.3300
73828639|NCT03098979|147204027|SUPERIORITY|||||||0.6232||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.6232
73828640|NCT03098979|147204027|SUPERIORITY|||||||0.0918||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.0918
73828641|NCT03098979|147204027|SUPERIORITY|||||||0.2701||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.2701
73828642|NCT02369653|147204036|SUPERIORITY|||||||0.0403|||||||Cochran-Mantel-Haenszel|||||||0.0403
73828643|NCT02369653|147204037|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
73828644|NCT02897349|147204060|SUPERIORITY||Adjusted Mean Difference (%)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0016|TWO_SIDED|95.0|-0.65|-0.16|||Mixed model repeated measures|||Based on Mixed-effect Model Repeated Measures (MMRM) including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline HbA1c by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).||-0.16|-0.65|0.0016
73828645|NCT02897349|147204061|SUPERIORITY||Adjusted Mean Difference (mg/dL)|-6.2|STANDARD_ERROR_OF_MEAN|5.1||0.2241|TWO_SIDED|95.0|-16.2|3.8|||Mixed model repeated measures|||Based on MMRM including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline FPG baseline FPG by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).||3.8|-16.2|0.2241
73828646|NCT02897349|147204062|SUPERIORITY||Adjusted Mean Difference (mg/dL)|-31.95|STANDARD_ERROR_OF_MEAN|8.2||0.0001|TWO_SIDED|95.0|-48.15|-15.75|||ANCOVA|||Based on analysis of covariance (ANCOVA) model including fixed effect treatment and type of insulin, and linear covariates baseline HbA1c and baseline 2-h PPG.||-15.75|-48.15|0.0001
73828647|NCT02897349|147204063|SUPERIORITY||Odds Ratio (OR)|1.793||||0.2431|TWO_SIDED|95.0|0.673|4.78|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||4.780|0.673|0.2431
73828648|NCT02897349|147204064|SUPERIORITY||Odds Ratio (OR)|1.481||||0.6235|TWO_SIDED|95.0|0.309|7.105|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||7.105|0.309|0.6235
73828649|NCT02897349|147204065|SUPERIORITY||Odds Ratio (OR)|2.293||||0.0049|TWO_SIDED|95.0|1.286|4.091|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||4.091|1.286|0.0049
73828650|NCT01259245|147204098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017||||0.252|TWO_SIDED|95.0|-0.046|0.012||Regression coefficients from ANCOVA for Tai Chi intervention (PRP as reference) at 6 months after adjusted for baseline value of the outcome variable, age, sex, BMI, smoking and education|ANCOVA|||||0.012|-0.046|0.252
73828651|NCT01259245|147204099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_DEVIATION|0.442||0.984|TWO_SIDED|95.0|-0.438|0.447|||ANCOVA|Adjusted for baseline values, age, sex, education, BMI and smoking||power0.80 for a medium effect size at 5% level of significance||0.447|-0.438|0.984
73828652|NCT01259245|147204100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372|STANDARD_DEVIATION|4.433||0.869|TWO_SIDED|95.0|-4.061|4.805|||ANCOVA|adjusted for baseline values, age, sex, education, BMI and education||power of 0.80 for a medium effect size at 5% level of significance||4.805|-4.061|0.869
73828653|NCT01259245|147204101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.295|STANDARD_DEVIATION|4.706||0.588|TWO_SIDED|95.0|-6.001|3.411|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium size effect at 5% level of significance||3.411|-6.001|0.588
73828654|NCT01259245|147204102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_DEVIATION|4.477||0.345|TWO_SIDED|95.0|-6.627|2.327|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||2.327|-6.627|0.345
73828655|NCT01259245|147204103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|4.062||0.413|TWO_SIDED|95.0|-5.753|2.372|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||2.372|-5.753|0.413
73828656|NCT01259245|147204104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.049|STANDARD_DEVIATION|8.89||0.004|TWO_SIDED|95.0|4.159|21.939|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||21.939|4.159|0.004
73828657|NCT01259245|147204105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_DEVIATION|0.226||0.56|TWO_SIDED|95.0|-0.1|0.184|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||0.184|-0.100|0.560
73828658|NCT01259245|147204106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_DEVIATION|0.088||0.425|TWO_SIDED|95.0|-0.054|0.128|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||0.128|-0.054|0.425
73828659|NCT01259245|147204107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|5.2||0.528|TWO_SIDED|95.0|-3.5|6.8|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||6.8|-3.5|0.528
73828660|NCT00447083|147204111|OTHER|||||||0.1811|||||||t-test, 2 sided|||||||.1811
73828661|NCT03363906|147204116|SUPERIORITY||Ratio Geometric Least Squares (LS) Mean|1.04||||0.473|TWO_SIDED|90.0|0.949|1.14|||Mixed Models Analysis|||||1.14|0.949|0.473
73828662|NCT03363906|147204117|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.119|TWO_SIDED|90.0|0.993|1.3|||ANOVA|||||1.30|0.993|0.119
73828663|NCT00997893|147204159|OTHER|||||||0.004||||||treatment x time p=.004|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo. Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.004
73828664|NCT00997893|147204160|OTHER|||||||0.98||||||visit x time x treatment interaction p=.98|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo before and after a psychosocial stressor. Predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.|||.98
73828665|NCT00997893|147204161|OTHER|||||||0.68||||||treatment x time (before and after the psychosocial stressor) x visit p=.68|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on emotional memory following a laboratory induced stress. Primary predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.|||.68
73828666|NCT00997893|147204162|OTHER|||||||0.11||||||treatment x time p=.11|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate). Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.11
73828667|NCT00997893|147204163|OTHER|||||||0.86||||||treatment x time p=.86|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate)Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.86
73828668|NCT01258049|147204164|SUPERIORITY_OR_OTHER||Percentage Difference|54.85|||<|0.005|TWO_SIDED|95.0|42.25|67.45|||Regression, Logistic|||In ART003, the parasite success rate for quinine was 67.7%. On the assumption that the parasite success rate was 70% for quinine in this study and in order to demonstrate that ArTiMist™ is superior to quinine by at least 20% the success rate for ArTiMist™ should be at least 90%. Using these figures, and assuming a power of 80%, an alpha of 0.05 (two sided) and based on an equal allocation to the ArTiMist™ and quinine treatment arms, the number of subjects (n) required on each treatment was 59.||67.45|42.25|<0.005
73828669|NCT01258049|147204165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.97|||<|0.05|TWO_SIDED|95.0|-62.22|-15.72|||ANCOVA|||||-15.72|-62.22|<0.05
73828670|NCT01258049|147204166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.91|||<|0.005|TWO_SIDED|95.0|-17.38|-8.44|||ANCOVA|||||-8.44|-17.38|<0.005
73828671|NCT01258049|147204167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.16|||<|0.005|TWO_SIDED|95.0|-11.71||||Regression, Cox|||||- 6.61|-11.71|<0.005
73828672|NCT01258049|147204168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.02|||<|0.005|TWO_SIDED|95.0|27.05|80.98|||ANCOVA|||||80.98|27.05|<0.005
73828673|NCT01258049|147204169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|174.09||||0.06|TWO_SIDED|95.0|-10.44|358.61|||ANCOVA||mean parasite counts increased in the first 12 hours for patients on quinine treatment|||358.61|-10.44|0.06
73828674|NCT01258049|147204170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.86|TWO_SIDED|95.0|-10.16|12.08|||Regression, Cox|||||12.08|-10.16|0.86
73828675|NCT01258049|147204171|SUPERIORITY_OR_OTHER||Percentage Difference|0.99||||0.99|TWO_SIDED|95.0|0.42|2.36|||Regression, Logistic|||||2.36|0.42|0.99
73828676|NCT01258049|147204174|SUPERIORITY_OR_OTHER||Percentage Difference|55.01|||<|0.005|TWO_SIDED|95.0|42.44|67.58|||Regression, Linear|||||67.58|42.44|<0.005
73828677|NCT01142336|147204180|SUPERIORITY|||||||0.53||||||Threshold for significance: 0.05, adjust for 3 primary outcomes using Holm Correction|ANCOVA|Response variable was Aβ42 in CSF at 1 year, and predictor variables were Aβ42 in CSF at baseline, treatment group, age, sex, and APOE e4 allele.||||||0.53
73828678|NCT01142336|147204181|SUPERIORITY|||||||0.36||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction|ANCOVA|Response variable was total tau in CSF at 1 year, and predictor were total tau in at baseline, treatment group, age, sex, and APOE e4 allele status||||||0.36
73828679|NCT01142336|147204182|SUPERIORITY|||||||0.25||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction.|ANCOVA|Response variable was p-tau181 in CSF at 1 year, and predictor were p-tau181 in at baseline, treatment group, age, sex, and APOE e4 allele status||||||0.25
73828680|NCT01041859|147204213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.234|<|0.001|TWO_SIDED|95.0|-1.415|-0.493||Analysis of covariance (ANCOVA) model was used with treatment, dose level, and pooled analysis center as factors and baseline pain intensity score as a covariate|ANCOVA||Mean Difference is least squares mean change in DB Tapentadol ER group minus least squares mean change in DB Placebo group (based on ANCOVA model)|The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 1.0 with an SD of 2.6, 144 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a DB treatment group for the study was 300.||-0.493|-1.415|<0.001
73828681|NCT02908347|147204237|SUPERIORITY||Median Difference (Final Values)|0.64||||0.8785|TWO_SIDED|95.0|-2.09|3.36|||Wilcoxon (Mann-Whitney)|||||3.36|-2.09|0.8785
73828682|NCT02908347|147204240|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 30 - Day 29||||1
73828683|NCT02908347|147204240|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 50 - Day 29||||1
73828684|NCT02908347|147204240|SUPERIORITY|||||||0.5136|||||||Fisher Exact|||PASI 30 - Day 43||||0.5136
73828685|NCT02908347|147204240|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 50 - Day 43||||1
73828686|NCT02717195|147204259|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.9196|TWO_SIDED|95.0|-2.37|2.13||Multiplicity adjustment was planned for the testing of the primary enpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||2.13|-2.37|0.9196
73828687|NCT02717195|147204259|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.1474|TWO_SIDED|95.0|-0.59|3.94||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||3.94|-0.59|0.1474
73828688|NCT02717195|147204260|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.2998|TWO_SIDED|95.0|-0.86|2.78||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||2.78|-0.86|0.2998
73828689|NCT02717195|147204260|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.4478|TWO_SIDED|95.0|-2.54|1.12||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||1.12|-2.54|0.4478
73828690|NCT01420536|147204290|SUPERIORITY_OR_OTHER_LEGACY|||||||0.569|TWO_SIDED|95.0||||P values less than 0.05 would be considered statistically significant in this study.|Wilcoxon (Mann-Whitney)|||Statistical analysis was performed by a researcher who was unaware of all procedures performed. The questionnaire about denture satisfaction originated a general score that was compared using the Wilcoxon test, according to the two tested conditions.||||0.569
73828691|NCT01420536|147204291|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|TWO_SIDED|95.0||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.339
73828692|NCT01420536|147204292|SUPERIORITY|||||||0.515||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.515
73828693|NCT01420536|147204293|SUPERIORITY_OR_OTHER_LEGACY|||||||0.485||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.485
73828694|NCT01420536|147204294|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.111
73828695|NCT01420536|147204295|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.399
73828696|NCT01420536|147204296|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.550
73828697|NCT01420536|147204297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.609
73828698|NCT01420536|147204298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.600
73828699|NCT01420536|147204299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.611||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.611
73828700|NCT01420536|147204300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.044
73828701|NCT01420536|147204301|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.677
73828702|NCT01420536|147204302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.885||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.885
73828703|NCT02941640|147204306|OTHER|Anova|||||<|0.0001||||||Significant when P\<0.05|ANOVA|||||||<0.0001
73828704|NCT02941640|147204306|OTHER|||||||0.001||||||Significant when P\<0.05.|Tukey post hoc test|||Post hoc analysis was done by Tukey test.||||0.001
73828705|NCT02941640|147204306|OTHER|Tukey post hoc test|||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
73828706|NCT02941640|147204306|OTHER|||||||0.044||||||Significant when P\<0.05|Tukey post hoc test|||||||0.044
73828707|NCT02941640|147204306|OTHER||||||<|0.272||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.272
73828708|NCT02941640|147204306|OTHER|||||||0.835||||||Significant when P\<0.05.|Tukey post hoc test|||||||0.835
73828709|NCT02941640|147204306|OTHER|||||||0.199||||||Significant when P\<0.05.|Tukey post hoc test|||||||0.199
73828710|NCT02941640|147204307|OTHER|Anova|||||<|0.0001||||||Significant when P\<0.05.|ANOVA|||||||<0.0001
73828711|NCT02941640|147204307|OTHER||||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
73828712|NCT02941640|147204307|OTHER||||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
73828713|NCT02941640|147204307|OTHER||||||<|0.0001||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.0001
73828714|NCT02941640|147204307|OTHER||||||<|0.0001|||||||Tukey post hoc test|||||||<0.0001
73828715|NCT02941640|147204307|OTHER||||||<|0.0001||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.0001
73828716|NCT02941640|147204307|OTHER|||||||1||||||Significant when P\<0.05|Tukey post hoc test|||||||1.00
73828717|NCT01265498|147204309|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.9||||0.0002|TWO_SIDED|95.0|1.3|2.8|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status.|obeticholic acid vs placebo|||2.8|1.3|0.0002
73828718|NCT01265498|147204310|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.08|TWO_SIDED|95.0|0.9|2.6|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.6|0.9|0.08
73828719|NCT01265498|147204311|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8||||0.004|TWO_SIDED|95.0|1.1|2.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.7|1.1|0.004
73828720|NCT01265498|147204312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.01|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-0.6|0.01
73828721|NCT01265498|147204313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.5|-1.3|<0.0001
73828722|NCT01265498|147204314|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.03|TWO_SIDED|95.0|1.0|2.1|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.1|1.0|0.03
73828723|NCT01265498|147204315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.03|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.0|-0.5|0.03
73828724|NCT01265498|147204316|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.7||||0.001|TWO_SIDED|95.0|1.2|2.3|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||2.3|1.2|0.001
73828725|NCT01265498|147204317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.2|-0.6|0.0004
73828726|NCT01265498|147204318|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6||||0.006|TWO_SIDED|95.0|1.1|2.2|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||2.2|1.1|0.006
73828727|NCT01265498|147204319|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.0006|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-0.5|0.0006
73828728|NCT01265498|147204320|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.9|TWO_SIDED|95.0|0.6|1.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||1.7|0.6|0.90
73828729|NCT01265498|147204321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.59|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.2|-0.1|0.59
73828730|NCT01265498|147204322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-11.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-11|-28|<0.0001
73828731|NCT01265498|147204323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.0001|TWO_SIDED|95.0|-18.0|-6.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-6|-18|0.0001
73828732|NCT01265498|147204324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0|||<|0.0001|TWO_SIDED|95.0|13.0|24.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||24|13|<0.0001
73828733|NCT01265498|147204325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.0|||<|0.0001|TWO_SIDED|95.0|-35.0|-14.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-14|-35|<0.0001
73828734|NCT01265498|147204326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.002|TWO_SIDED|95.0|-2.4|-0.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.5|-2.4|0.002
73828735|NCT01265498|147204327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.0009|TWO_SIDED|95.0|0.16|0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.60|0.16|0.0009
73828736|NCT01265498|147204328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.01|TWO_SIDED|95.0|-0.1|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.01|-0.10|0.01
73828737|NCT01265498|147204329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|||<|0.0001|TWO_SIDED|95.0|0.26|0.65|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.65|0.26|<0.0001
73828738|NCT01265498|147204330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.88|TWO_SIDED|95.0|-0.35|0.3|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.30|-0.35|0.88
73828739|NCT01265498|147204331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.72|TWO_SIDED|95.0|-1.8|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2.6|-1.8|0.72
73828740|NCT01265498|147204332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.71|TWO_SIDED|95.0|-0.01|0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.01|-0.01|0.71
73828741|NCT01265498|147204333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.002|TWO_SIDED|95.0|-1.8|-0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.4|-1.8|0.002
73828742|NCT01265498|147204334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.4|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.4|-0.2|0.40
73828743|NCT01265498|147204335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.001|TWO_SIDED|95.0|7.0|26.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||26|7|0.001
73828744|NCT01265498|147204336|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.03|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-1.4|0.03
73828745|NCT01265498|147204337|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.04|TWO_SIDED|95.0|0.0|0.04|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.04|0.00|0.04
73828746|NCT01265498|147204338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.53|TWO_SIDED|95.0|-0.03|0.05|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.05|-0.03|0.53
73828747|NCT01265498|147204339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.03|TWO_SIDED|95.0|0.2|5.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||5.0|0.2|0.03
73828748|NCT01265498|147204340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.0||||0.05|TWO_SIDED|95.0|0.0|29.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||29|0|0.05
73828749|NCT01265498|147204341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.13|TWO_SIDED|95.0|-1.2|0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.2|-1.2|0.13
73828750|NCT01265498|147204342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.31|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1.6|-0.5|0.31
73828751|NCT01265498|147204343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.16|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.1|-0.6|0.16
73828752|NCT01265498|147204344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.002|TWO_SIDED|95.0|-0.04|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.01|-0.04|0.002
73828753|NCT01265498|147204345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.26|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.8|-0.2|0.26
73828754|NCT01265498|147204346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0||||0.02|TWO_SIDED|95.0|6.0|69.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||69|6|0.02
73828755|NCT01265498|147204347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.01|TWO_SIDED|95.0|3.0|23.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||23|3|0.01
73828756|NCT01265498|147204348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.71|TWO_SIDED|95.0|-1.7|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2.6|-1.7|0.71
73828757|NCT01265498|147204349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.008|TWO_SIDED|95.0|-3.7|-0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.6|-3.7|0.008
73828758|NCT01265498|147204350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.01|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.2|-1.3|0.01
73828759|NCT01265498|147204351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.7|TWO_SIDED|95.0|-2.2|1.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1.5|-2.2|0.70
73828760|NCT01265498|147204352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.57|TWO_SIDED|95.0|-0.01|0.02|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.02|-0.01|0.57
73828761|NCT01265498|147204353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.05|TWO_SIDED|95.0|-7.0|0.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0|-7|0.05
73828762|NCT01265498|147204354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.23|TWO_SIDED|95.0|-4.0|1.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1|-4|0.23
73828763|NCT01265498|147204355|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.22|TWO_SIDED|95.0|-1.0|3.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||3|-1|0.22
73828764|NCT01265498|147204356|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.65|TWO_SIDED|95.0|-3.0|2.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2|-3|0.65
73828765|NCT04030598|147204397|SUPERIORITY||Percentage Difference|-90.0||||0.001|TWO_SIDED|95.0|-96.0|-76.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100 percentage (%) × (mean rate ratio -1).|||-76.00|-96.00|0.001
73828766|NCT04030598|147204398|SUPERIORITY||Percentage Difference|-89.0||||0.003|TWO_SIDED|95.0|-95.0|-77.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100% × (mean rate ratio -1).|||-77.00|-95.00|0.003
73828767|NCT04030598|147204399|SUPERIORITY||Percentage Difference|-96.0||||0.004|TWO_SIDED|95.0|-100.0|-65.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100% × (mean rate ratio -1).|||-65.00|-100.00|0.004
73828768|NCT04030598|147204400|SUPERIORITY||Risk Difference (RD)|66.7||||0.004|TWO_SIDED|95.0|17.5|95.7|||Fisher Exact|||For ≥ 50% reduction from Baseline in the HAE attack rate.||95.7|17.5|0.004
73828769|NCT04030598|147204400|SUPERIORITY||Risk Difference (RD)|75.6||||0.003|TWO_SIDED|95.0|26.8|96.5|||Fisher Exact|||For ≥ 70% reduction from Baseline in the HAE attack rate.||96.5|26.8|0.003
73828770|NCT04030598|147204400|SUPERIORITY||Risk Difference (RD)|92.3|||<|0.001|TWO_SIDED|95.0|48.0|99.8|||Fisher Exact|||For ≥ 90% reduction from Baseline in the HAE attack rate.||99.8|48.0|<0.001
73828771|NCT04030598|147204401|SUPERIORITY||Percentage Difference|-95.0||||0.009|TWO_SIDED|95.0|-99.0|-52.0|||Wald Chi-Square|||||-52.00|-99.00|0.009
73828772|NCT04030598|147204404|SUPERIORITY||Risk Difference (RD)|-14.3||||1|TWO_SIDED|95.0|-59.1|33.9|||Fisher Exact|||Week 9||33.9|-59.1|1.000
73828773|NCT04030598|147204404|SUPERIORITY||Risk Difference (RD)|-21.4||||0.521|TWO_SIDED|95.0|-64.9|27.1|||Fisher Exact|||Week 17||27.1|-64.9|0.521
73828774|NCT04030598|147204405|SUPERIORITY||Treatment Difference|-25.92|||||TWO_SIDED|95.0|-37.1|-14.74||||||Week 9||-14.74|-37.10|
73828775|NCT04030598|147204405|SUPERIORITY||Treatment Difference|-20.69|||||TWO_SIDED|95.0|-32.7|-8.68||||||Week 17||-8.68|-32.70|
73828776|NCT03658980|147204406|SUPERIORITY||Odds Ratio (OR)|0.233|||<|0.001|TWO_SIDED|95.0|0.131|0.415|||Regression, Logistic|||||0.415|0.131|<0.001
73828777|NCT04459338|147204438|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||All continuous data are summarized as means ± SEM. Area Under the Curve (AUC) was calculated using the trapezoidal rule. A paired, two-way Student t-test (parametric) or a Wilcoxon matched-pairs signed rank test (non-parametric) was used to examine differences between study days. A p-value \<0.05 was considered statistically significant.||||0.02
73828778|NCT03720119|147204473|OTHER|Analysis of Variance for repeated measurements.|day effect F|27.83||||0.0001|TWO_SIDED|||||The calculated P-Value represents the repeated measurement/Day (all times versus Day 1)|Dunnett's post-hoc test|||||||0.0001
73828779|NCT02065557|147204506|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
73828780|NCT02065557|147204506|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
73828781|NCT02065557|147204506|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||0.382
73828782|NCT02065557|147204506|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
73828783|NCT02065557|147204506|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
73828784|NCT02065557|147204506|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||0.344
73828785|NCT02065557|147204507|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828786|NCT02065557|147204507|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828787|NCT02065557|147204507|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
73828788|NCT02065557|147204507|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828789|NCT02065557|147204507|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828790|NCT02065557|147204507|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
73828791|NCT02065557|147204508|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828792|NCT02065557|147204508|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|Chi-squared|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828793|NCT02065557|147204508|SUPERIORITY|one-sample two-sided Chi-square test||||||0.008||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|Chi-squared|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.008
73828794|NCT02065557|147204508|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828795|NCT02065557|147204508|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828796|NCT02065557|147204508|SUPERIORITY|one-sample two-sided Chi-square test||||||0.038||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.038
73828797|NCT02065557|147204509|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828798|NCT02065557|147204509|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828799|NCT02065557|147204509|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
73828800|NCT02065557|147204509|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828801|NCT02065557|147204509|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828802|NCT02065557|147204509|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
73828803|NCT02065557|147204510|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828804|NCT02065557|147204510|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828805|NCT02065557|147204510|SUPERIORITY|one-sample two-sided Chi-square test||||||0.292||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.292
73828806|NCT02065557|147204510|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828807|NCT02065557|147204510|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
73828808|NCT02065557|147204510|SUPERIORITY|one-sample two-sided Chi-square test||||||0.292||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.292
73828809|NCT02065557|147204511|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
73828810|NCT02065557|147204511|SUPERIORITY|one-sample two-sided Chi-square test||||||1||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||1.000
73828811|NCT02065557|147204511|SUPERIORITY|one-sample two-sided Chi-square test||||||1||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||1.000
73828812|NCT02065557|147204511|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
73828813|NCT02065557|147204511|SUPERIORITY|one-sample two-sided Chi-square test||||||0.559||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.559
73828814|NCT02065557|147204511|SUPERIORITY|one-sample two-sided Chi-square test||||||0.815||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.815
73828815|NCT00250588|147204512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.05|TWO_SIDED|95.0|0.63|7.4||Bonferroni adjustment.|Mixed Models Analysis|Adjusted for child's age, race/ethnicity, Spanish, mother's education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.||7.4|0.63|0.05
73828816|NCT00250588|147204512|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.1||||0.05|TWO_SIDED|95.0|-0.21|6.4||Bonferroni adjustment|Mixed Models Analysis|Adjusted for child's age, race/ethnicity, Spanish, mother's education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.||6.4|-0.21|0.05
73828817|NCT00250588|147204513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.21|TWO_SIDED|95.0|0.18|1.38|||Regression, Logistic|Adjustment for age, race/ethnicity, Spanish language and mother's education||||1.38|0.18|0.21
73828818|NCT00250588|147204513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.85|TWO_SIDED|95.0|0.53|2.83||adjustment for age, race/ethnicity, Spanish language and mother's education|Regression, Logistic|||||2.83|0.53|0.85
73828819|NCT00250588|147204514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.011|TWO_SIDED|95.0|0.13|0.82|||Regression, Logistic|All analyses accounted for repeated measures and included the same terms in the model described previously.||Symptom frequency and utilization were analyzed using generalized linear mixed models (GLMM), with appropriate distribution and link functions. Nighttime symptoms is a dichotomous outcome and a logistic model was constructed.||0.82|0.13|0.011
73828820|NCT02737722|147204535|SUPERIORITY|||||||0.5152|||||||Fisher Exact|||Day 1 (Visit 2)||||0.5152
73828821|NCT02737722|147204535|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 1 (Visit 2)||||1.0000
73828822|NCT02737722|147204535|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)||||1.0000
73828823|NCT02737722|147204535|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)||||1.0000
73828824|NCT02737722|147204535|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)||||1.0000
73828825|NCT02737722|147204535|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)||||1.0000
73828826|NCT02737722|147204535|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 15 (Visit 5)||||1.0000
73828827|NCT02737722|147204535|SUPERIORITY|||||||0.3636|||||||Fisher Exact|||Day 15 (Visit 5)||||0.3636
73828828|NCT02737722|147204536|SUPERIORITY|||||||0.172|||||||Wilcoxon Rank Sum Test|||||||0.172
73828829|NCT02737722|147204536|SUPERIORITY|||||||0.365|||||||Wilcoxon Rank Sum Test|||||||0.365
73828830|NCT02737722|147204536|SUPERIORITY|||||||0.619|||||||Wilcoxon Rank Sum Test|||||||0.619
73828831|NCT02737722|147204537|SUPERIORITY|||||||0.432|||||||Wilcoxon Rank Sum Test|||||||0.432
73828832|NCT02737722|147204537|SUPERIORITY|||||||0.435|||||||Wilcoxon Rank Sum Test|||||||0.435
73828833|NCT02737722|147204537|SUPERIORITY|||||||0.715|||||||Wilcoxon Rank Sum Test|||||||0.715
73828834|NCT02737722|147204538|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
73828835|NCT02737722|147204538|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
73828836|NCT02737722|147204538|SUPERIORITY|||||||0.153|||||||Wilcoxon Rank Sum Test|||||||0.153
73828837|NCT02737722|147204539|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
73828838|NCT02737722|147204539|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
73828839|NCT02737722|147204539|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
73828840|NCT02737722|147204540|SUPERIORITY|||||||0.361|||||||Wilcoxon Rank Sum Test|||||||0.361
73828841|NCT02737722|147204540|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
73828842|NCT02737722|147204540|SUPERIORITY|||||||0.153|||||||Wilcoxon Rank Sum Test|||||||0.153
73828843|NCT02737722|147204541|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
73828844|NCT02737722|147204541|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
73828845|NCT02737722|147204541|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
73828846|NCT02737722|147204543|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
73828847|NCT02737722|147204543|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
73828848|NCT02737722|147204543|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
73828849|NCT00477685|147204593|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||Null hypothesis: the postoperative intraocular pressure at 90 days equals the preoperative intraocular pressure at baseline.||||0.01
73828850|NCT03444584|147204594|SUPERIORITY||LS mean difference|-143.09|||<|0.0001|TWO_SIDED|95.0|-198.2|-87.98|||ANCOVA|||||-87.98|-198.20|<0.0001
73828851|NCT03444584|147204595|SUPERIORITY||LS mean difference|-22.17|||<|0.0001|TWO_SIDED|95.0|-30.24|-14.1|||ANCOVA|||||-14.10|-30.24|<0.0001
73828852|NCT03704064|147204630|SUPERIORITY||Mean Difference (Net)|-1.97|STANDARD_ERROR_OF_MEAN|1.32||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
73828853|NCT03704064|147204631|SUPERIORITY||Odds Ratio (OR)|1.1||||0.89|TWO_SIDED|95.0|0.4|3.4|||Mixed Models Analysis|||||3.4|0.4|0.89
73828854|NCT03704064|147204632|SUPERIORITY||Odds Ratio (OR)|3.7||||0.06|TWO_SIDED|95.0|1.0|14.7|||Mixed Models Analysis|||||14.7|1.0|0.06
73828855|NCT03704064|147204633|SUPERIORITY||Mean Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|1.3||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
73828856|NCT03704064|147204634|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||0.42
73828857|NCT03704064|147204635|SUPERIORITY||Odds Ratio (OR)|2.0||||0.24|TWO_SIDED|95.0|0.6|6.3|||Mixed Models Analysis|||||6.3|0.6|0.24
73828858|NCT03704064|147204636|SUPERIORITY||Odds Ratio (OR)|2.2||||0.24|TWO_SIDED|95.0|0.6|8.1|||Mixed Models Analysis|||||8.1|0.6|0.24
73828859|NCT03704064|147204637|SUPERIORITY||Odds Ratio (OR)|3.0||||0.07|TWO_SIDED|95.0|0.9|9.6|||Mixed Models Analysis|||||9.6|0.9|0.07
73828860|NCT03704064|147204638|SUPERIORITY||Odds Ratio (OR)|2.6||||0.21|TWO_SIDED|95.0|0.6|11.4|||Mixed Models Analysis|||||11.4|0.6|0.21
73828861|NCT03704064|147204639|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|5.8||0.62|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.62
73828862|NCT03704064|147204639|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|4.5||0.92|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.92
73828863|NCT03704064|147204639|SUPERIORITY||Mean Difference (Net)|13.4|STANDARD_ERROR_OF_MEAN|9.6||0.16|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.16
73828864|NCT03704064|147204639|SUPERIORITY||Mean Difference (Net)|15.9|STANDARD_ERROR_OF_MEAN|20.8||0.41|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.41
73828865|NCT03704064|147204640|SUPERIORITY||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|6.1||0.46|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.46
73828866|NCT03704064|147204640|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|4.9||0.87|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.87
73828867|NCT03704064|147204640|SUPERIORITY||Mean Difference (Net)|18.5|STANDARD_ERROR_OF_MEAN|10.1||0.07|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.07
73828868|NCT03704064|147204640|SUPERIORITY||Mean Difference (Net)|30.0|STANDARD_ERROR_OF_MEAN|22.5||0.17|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.17
73828869|NCT03704064|147204641|SUPERIORITY||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|5.7||0.63|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.63
73828870|NCT03704064|147204641|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|3.7||0.72|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.72
73828871|NCT03704064|147204641|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|9.4||0.52|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.52
73828872|NCT03704064|147204641|SUPERIORITY||Mean Difference (Net)|-21.8|STANDARD_ERROR_OF_MEAN|19.4||0.27|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.27
73828873|NCT03704064|147204642|SUPERIORITY||Mean Difference (Net)|7.3|STANDARD_ERROR_OF_MEAN|151.2||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
73828874|NCT03704064|147204643|SUPERIORITY||Mean Difference (Net)|-111.7|STANDARD_ERROR_OF_MEAN|137.2||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
73828875|NCT03704064|147204644|SUPERIORITY||Mean Difference (Net)|163.2|STANDARD_ERROR_OF_MEAN|154.0||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
73828876|NCT03704064|147204645|SUPERIORITY||Mean Difference (Net)|5.7|STANDARD_ERROR_OF_MEAN|4.6||0.22|TWO_SIDED||||||Mixed Models Analysis|||||||0.22
73828877|NCT03704064|147204646|SUPERIORITY||Mean Difference (Net)|5.3|STANDARD_ERROR_OF_MEAN|4.6||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
73828878|NCT03704064|147204647|SUPERIORITY||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|4.5||0.48|TWO_SIDED||||||Mixed Models Analysis|||||||0.48
73828879|NCT03704064|147204648|SUPERIORITY||Mean Difference (Net)|4.9|STANDARD_ERROR_OF_MEAN|3.4||0.16|TWO_SIDED||||||Mixed Models Analysis|||||||0.16
73828880|NCT03704064|147204649|SUPERIORITY||Mean Difference (Net)|6.8|STANDARD_ERROR_OF_MEAN|3.4||0.045|TWO_SIDED||||||Mixed Models Analysis|||||||0.045
73828881|NCT03704064|147204650|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|3.4||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
73828882|NCT03704064|147204651|SUPERIORITY||Mean Difference (Net)|3.9|STANDARD_ERROR_OF_MEAN|9.4||0.72|TWO_SIDED||||||Mixed Models Analysis|||||||0.72
73828883|NCT03704064|147204652|SUPERIORITY||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|9.1||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
73828884|NCT03704064|147204653|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|2.5||0.8|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.80
73828885|NCT03704064|147204653|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.1||0.94|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.94
73828886|NCT03704064|147204654|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|2.3||0.07|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.07
73828887|NCT03704064|147204654|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.5||0.96|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.96
73828888|NCT03704064|147204655|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||0.30
73828889|NCT03704064|147204656|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
73828890|NCT03704064|147204657|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
73828891|NCT03704064|147204658|SUPERIORITY||Odds Ratio (OR)|1.7||||0.38|TWO_SIDED|95.0|0.5|5.9|||Mixed Models Analysis|||||5.9|0.5|0.38
73828892|NCT03704064|147204659|SUPERIORITY||Odds Ratio (OR)|1.0||||0.95|TWO_SIDED|95.0|0.3|3.3|||Mixed Models Analysis|||||3.3|0.3|0.95
73828893|NCT03704064|147204660|SUPERIORITY||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.3|3.1|||Mixed Models Analysis|||||3.1|0.3|0.99
73828894|NCT03704064|147204661|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.6||0.06|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.06
73828895|NCT03704064|147204661|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.06|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.06
73828896|NCT03704064|147204661|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.9||0.19|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.19
73828897|NCT03704064|147204662|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.5||0.05|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.05
73828898|NCT03704064|147204662|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.9||0.18|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.18
73828899|NCT03704064|147204662|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.046|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.046
73828900|NCT03704064|147204663|SUPERIORITY||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.5||0.07|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.07
73828901|NCT03704064|147204663|SUPERIORITY||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.9||0.11|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.11
73828902|NCT03704064|147204663|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.15|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.15
73828903|NCT03704064|147204664|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.3||0.04|TWO_SIDED||||||ANOVA|||Overall treatment acceptability||||0.04
73828904|NCT03704064|147204664|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.35|TWO_SIDED||||||ANOVA|||BWL component acceptability||||0.35
73828905|NCT03704064|147204664|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED||||||ANOVA|||BIAS vs recipe component acceptability||||<0.001
73828906|NCT03704064|147204664|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED||||||ANOVA|||BWL skill acquisition||||0.01
73828907|NCT03704064|147204664|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill acquisition||||<0.001
73828908|NCT03704064|147204664|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill use||||<0.001
73828909|NCT03704064|147204665|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.24|TWO_SIDED||||||ANOVA|||Overall treatment acceptability||||0.24
73828910|NCT03704064|147204665|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.28|TWO_SIDED||||||ANOVA|||BWL component acceptability||||0.28
73828911|NCT03704064|147204665|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED||||||ANOVA|||BIAS vs recipe component acceptability||||<0.001
73828912|NCT03704064|147204665|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.34|TWO_SIDED||||||ANOVA|||BWL skill acquisition||||0.34
73828913|NCT03704064|147204665|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.3||0.008|TWO_SIDED||||||ANOVA|||Stigma-related skill acquisition||||0.008
73828914|NCT03704064|147204665|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill use||||0.001
73828915|NCT03040726|147204714|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
73828916|NCT03040726|147204715|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
73828917|NCT03040726|147204716|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
73828918|NCT03040726|147204717|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
73828919|NCT02783911|147204718|SUPERIORITY|||||||0.808|||||||Chi-squared|||||||0.808
73828920|NCT00071981|147204719|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare CTL response rate among four arms. The null hypothesis is that CTL response is same in all four arms. Alternative hypothesis is that CTL response rate is different in at least one arm compared to other arms.||||<0.001
73828921|NCT00071981|147204720|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare HTL response rate to 6MHP among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.||||<0.001
73828922|NCT00071981|147204721|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare HTL response rate to tetanus peptide among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.||||<0.001
73828923|NCT00071981|147204722|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741|TWO_SIDED|95.0|||||Fisher Exact|||Compare objective response rate among four arms. The null hypothesis is that objective response rate is same in all four arms. Alternative hypothesis is that objective response rate is different in at least one arm compared to other arms.||||0.741
73828924|NCT00071981|147204723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532|TWO_SIDED|95.0|||||Log Rank|||Compare overall survival curves among four arms.||||0.532
73828925|NCT01123655|147204724|EQUIVALENCE|P less than 0.05 was the criteria for equivalence.||||||0.5179|||||||Fisher Exact|||Specified to be a reduction from baseline values of net IFNƔ concentration of ≥ 25% in αl(ll)-stimulated PBMC culture supernatants (calculated as αI(II)-IFNƔ-PBS IFNƔ in patients receiving APL A12 compared to placebo.||||0.5179
73828926|NCT01123655|147204724|EQUIVALENCE|Null hypothesis was that the response rate in the APL treated groups is not significantly difference from the 50% spontaneous response rate.||||||0.0114|||||||Exact Test|||||||0.0114
73828927|NCT01123655|147204724|EQUIVALENCE|Null hypothesis was that the response rate in the placebo group is not significantly difference from the 50% spontaneous response rate.||||||0.4142|||||||Exact Test|||||||0.4142
73828928|NCT01123655|147204726|EQUIVALENCE|P greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable for baseline and follow-up data.|Mixed Models Analysis|||||||>0.05
73828929|NCT01123655|147204727|EQUIVALENCE|p value greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable to IL-17a, IL-10, IL-1b, IL-9, IL-13, IL-5, IL-21, IL-6, TNFa, TGFb, MIP3a.|t-test, 2 sided|||||||>0.05
73828930|NCT00885118|147204759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42828.482|STANDARD_ERROR_OF_MEAN|6487.174|<|0.0001|TWO_SIDED|95.0|29936.586|55720.378|||ANCOVA|The baseline value was included as a continuous covariate.||Difference calculated as empa 1mg minus placebo||55720.378|29936.586|<0.0001
73828931|NCT00885118|147204759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|80964.677|STANDARD_ERROR_OF_MEAN|6303.82|<|0.0001|TWO_SIDED|95.0|68437.16|93492.194|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||93492.194|68437.160|<0.0001
73828932|NCT00885118|147204759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88589.764|STANDARD_ERROR_OF_MEAN|6544.604|<|0.0001|TWO_SIDED|95.0|75583.738|101595.79|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||101595.790|75583.738|<0.0001
73828933|NCT00885118|147204759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85620.348|STANDARD_ERROR_OF_MEAN|6610.091|<|0.0001|TWO_SIDED|95.0|72484.181|98756.515|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||98756.515|72484.181|<0.0001
73828934|NCT00885118|147204760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|STANDARD_ERROR_OF_MEAN|4.155||0.003|TWO_SIDED|95.0|-20.936|-4.424|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-4.424|-20.936|0.0030
73828935|NCT00885118|147204760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.92|STANDARD_ERROR_OF_MEAN|4.025|<|0.0001|TWO_SIDED|95.0|-27.919|-11.921|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-11.921|-27.919|<0.0001
73828936|NCT00885118|147204760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.208|STANDARD_ERROR_OF_MEAN|4.168|<|0.0001|TWO_SIDED|95.0|-34.49|-17.925|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-17.925|-34.490|<0.0001
73828937|NCT00885118|147204760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.235|STANDARD_ERROR_OF_MEAN|4.202|<|0.0001|TWO_SIDED|95.0|-35.586|-18.884|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-18.884|-35.586|<0.0001
73828938|NCT00885118|147204761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.883|STANDARD_ERROR_OF_MEAN|5.861||0.003|TWO_SIDED|95.0|-29.529|-6.236|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-6.236|-29.529|0.0030
73828939|NCT00885118|147204761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.487|STANDARD_ERROR_OF_MEAN|5.445|<|0.0001|TWO_SIDED|95.0|-33.308|-11.665|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-11.665|-33.308|<0.0001
73828940|NCT00885118|147204761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.265|STANDARD_ERROR_OF_MEAN|5.785|<|0.0001|TWO_SIDED|95.0|-37.762|-14.768|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-14.768|-37.762|<0.0001
73828941|NCT00885118|147204761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.34|STANDARD_ERROR_OF_MEAN|5.699|<|0.0001|TWO_SIDED|95.0|-39.665|-17.015|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-17.015|-39.665|<0.0001
73828942|NCT00885118|147204762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.239|STANDARD_ERROR_OF_MEAN|0.13||0.0705|TWO_SIDED|95.0|-0.498|-0.02|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-0.020|-0.498|0.0705
73828943|NCT00885118|147204762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.125||0.0203|TWO_SIDED|95.0|-0.545|-0.047|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-0.047|-0.545|0.0203
73828944|NCT00885118|147204762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.429|STANDARD_ERROR_OF_MEAN|0.13||0.0014|TWO_SIDED|95.0|-0.687|-0.17|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-0.170|-0.687|0.0014
73828945|NCT00885118|147204762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.395|STANDARD_ERROR_OF_MEAN|0.131||0.0033|TWO_SIDED|95.0|-0.654|-0.135|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-0.135|-0.654|0.0033
73828946|NCT00885118|147204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.527|STANDARD_ERROR_OF_MEAN|17.755||0.4823|TWO_SIDED|95.0|-22.757|47.811|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||47.811|-22.757|0.4823
73828947|NCT00885118|147204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.984|STANDARD_ERROR_OF_MEAN|17.313||0.7305|TWO_SIDED|95.0|-28.422|40.39|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||40.390|-28.422|0.7305
73828948|NCT00885118|147204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.858|STANDARD_ERROR_OF_MEAN|17.903||0.3213|TWO_SIDED|95.0|-53.438|17.721|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||17.721|-53.438|0.3213
73828949|NCT00885118|147204763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.838|STANDARD_ERROR_OF_MEAN|18.13||0.2768|TWO_SIDED|95.0|-55.869|16.192|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||16.192|-55.869|0.2768
73828950|NCT00885118|147204764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.192|STANDARD_ERROR_OF_MEAN|0.728|<|0.0001|TWO_SIDED|95.0|-5.653|-2.731|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-2.731|-5.653|<0.0001
73828951|NCT00885118|147204764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.609|STANDARD_ERROR_OF_MEAN|0.756|<|0.0001||95.0|-6.126|-3.091|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-3.091|-6.126|<0.0001
73828952|NCT00885118|147204764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.036|STANDARD_ERROR_OF_MEAN|0.762|<|0.0001|TWO_SIDED|95.0|-5.565|-2.508|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-2.508|-5.565|<0.0001
73828953|NCT00885118|147204764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.887|STANDARD_ERROR_OF_MEAN|1.076|<|0.0001|TWO_SIDED|95.0|-7.048|-2.726|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-2.726|-7.048|<0.0001
73828954|NCT00885118|147204765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.414||0.2498|TWO_SIDED|95.0|-1.302|0.343|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||0.343|-1.302|0.2498
73828955|NCT00885118|147204765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.379|STANDARD_ERROR_OF_MEAN|0.408||0.3544|TWO_SIDED|95.0|-1.189|0.43|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||0.430|-1.189|0.3544
73828956|NCT00885118|147204765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.343|STANDARD_ERROR_OF_MEAN|0.416||0.0018|TWO_SIDED|95.0|-2.171|-0.516|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-0.516|-2.171|0.0018
73828957|NCT00885118|147204765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.257|STANDARD_ERROR_OF_MEAN|0.421||0.0037|TWO_SIDED|95.0|-2.094|-0.419|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-0.419|-2.094|0.0037
73828958|NCT00885118|147204766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-95.414|STANDARD_ERROR_OF_MEAN|15.388|<|0.0001|TWO_SIDED|95.0|-125.995|-64.833|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-64.833|-125.995|<0.0001
73828959|NCT00885118|147204766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-109.48|STANDARD_ERROR_OF_MEAN|14.67|<|0.0001|TWO_SIDED|95.0|-138.633|-80.327|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-80.327|-138.633|<0.0001
73828960|NCT00885118|147204766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-131.336|STANDARD_ERROR_OF_MEAN|15.354|<|0.0001|TWO_SIDED|95.0|-161.848|-100.824|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-100.824|-161.848|<0.0001
73828961|NCT00885118|147204766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-136.341|STANDARD_ERROR_OF_MEAN|15.357|<|0.0001|TWO_SIDED|95.0|-166.86|-105.823|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-105.823|-166.860|<0.0001
73828962|NCT00885118|147204767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.668|STANDARD_ERROR_OF_MEAN|13.152||0.0883|TWO_SIDED|95.0|-3.47|48.805|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||48.805|-3.470|0.0883
73828963|NCT00885118|147204767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.576|STANDARD_ERROR_OF_MEAN|12.941||0.0203|TWO_SIDED|95.0|4.859|56.293|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||56.293|4.859|0.0203
73828964|NCT00885118|147204767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.974|STANDARD_ERROR_OF_MEAN|13.289||0.6541|TWO_SIDED|95.0|-20.434|32.382|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||32.382|-20.434|0.6541
73828965|NCT00885118|147204767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.015|STANDARD_ERROR_OF_MEAN|13.612||0.4206|TWO_SIDED|95.0|-16.036|38.066|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||38.066|-16.036|0.4206
73828966|NCT00885118|147204768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.869|STANDARD_ERROR_OF_MEAN|4.066||0.0318|TWO_SIDED|95.0|-16.949|-0.789|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-0.789|-16.949|0.0318
73828967|NCT00885118|147204768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.344|STANDARD_ERROR_OF_MEAN|3.966||0.0005|TWO_SIDED|95.0|-22.225|-6.462|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-6.462|-22.225|0.0005
73828968|NCT00885118|147204768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.642|STANDARD_ERROR_OF_MEAN|4.131||0.0003|TWO_SIDED|95.0|-23.853|-7.432|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-7.432|-23.853|0.0003
73828969|NCT00885118|147204768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.118|STANDARD_ERROR_OF_MEAN|4.137||0.0164|TWO_SIDED|95.0|-18.339|-1.897|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-1.897|-18.339|0.0164
73828970|NCT03699748|147204792|OTHER||Mean Difference (Net)|10.92|||<|0.001|TWO_SIDED|95.0|7.27|14.58|||Type III F test|||||14.58|7.27|<0.001
73828971|NCT03699748|147204795|OTHER||Effect Estimate for 4 Months|12.88|||||TWO_SIDED||||||||12.88 (9.49 - 16.28)||Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person. The effect estimate column shows the difference between change in the intervention group from baseline and the change in the control group from baseline.|||
73828972|NCT03699748|147204796|OTHER||Effect Estimate for 12 Months|20.65|||||TWO_SIDED||||||||20.65 (6.97 - 24.32)||Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person.|||
73828973|NCT03699748|147204797|OTHER||Median Difference (Net)|11.05||||0.001|TWO_SIDED|95.0|7.09|15.0|||Type III F-test|||||15.00|7.09|0.001
73828974|NCT03699748|147204799|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED||||||||0.91 (0.40-2.09)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
73828975|NCT03699748|147204800|OTHER||Odds Ratio (OR)|0.27|||||TWO_SIDED||||||||0.27 (0.03 - 2.85)||Odds Ratios for any ED Use were estimated using logistic regression models.|||
73828976|NCT03699748|147204801|OTHER||Odds Ratio (OR)|0.38|||||TWO_SIDED||||||||0.38 (0.18-0.76)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
73828977|NCT03699748|147204802|OTHER||Odds Ratio (OR)|0.42|||||TWO_SIDED||||||||0.42 (0.22-0.79)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
73828978|NCT03699748|147204803|OTHER||Odds Ratio (OR)|0.38|||||TWO_SIDED||||||||0.38 (0.08-1.75)||Odds Ratios for Hospitalization Use were estimated using logistic regression models.|||
73828979|NCT03699748|147204804|OTHER||Odds Ratio, log|5.86|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
73828980|NCT03699748|147204805|OTHER||Odds Ratio (OR)|4.09|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
73828981|NCT03699748|147204806|OTHER||Odds Ratio (OR)|6.82|||||TWO_SIDED||||||||6.82 (2.46-18.93)||Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months post-enrollment with logistic regression.|||
73828982|NCT03699748|147204807|OTHER||Odds Ratio (OR)|3.62|||||TWO_SIDED||||||||3.62 (1.73-7.60)||Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments at 12-months post-enrollment with logistic regression.|||
73828983|NCT03699748|147204808|OTHER||Odds Ratio, log|8.56|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
73828984|NCT03699748|147204809|OTHER||Odds Ratio, log|19.55|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments at 12-months post-enrollment with logistic regression.|||||
73828985|NCT03699748|147204810|OTHER||Effect Estimate|0.65|||||TWO_SIDED||||||||0.65 (0.44-0.98)||Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data after adjustment for length of follow-up.|||
73828986|NCT03699748|147204811|OTHER||Effect Estimate|0.57|||||TWO_SIDED||||||||0.57 (0.28 - 1.18)||Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data.|||
73828987|NCT03699748|147204812|OTHER||Odds Ratio (OR)|6.82|||||TWO_SIDED||||||||6.82 (2.46-18.93)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
73828988|NCT03699748|147204813|OTHER||Odds Ratio (OR)|3.62|||||TWO_SIDED||||||||3.62 (1.73-7.60)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
73828989|NCT03699748|147204814|OTHER||Effect Estimate|5.71|||||TWO_SIDED||||||||5.71 (1.56-20.93)||Odds Ratios for any ED Use and any Palliative Care were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.|||
73828990|NCT03699748|147204815|OTHER||Odds Ratio (OR)|4.33|||||TWO_SIDED||||||||4.33 (0.89-21.08)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
73828991|NCT03699748|147204816|OTHER||Odds Ratio (OR)|2.76|||||TWO_SIDED||||||||2.76 (1.01-7.55)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments at 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
73828992|NCT03699748|147204817|OTHER||Effect Estimate|5.71|||||TWO_SIDED||||||||5.71 (1.56-20.93)||Odds Ratios for any ED Use and any Hospice Receipt were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.|||
73828993|NCT02814526|147204821|SUPERIORITY||Mean Difference (Net)|0.078||||0.29|TWO_SIDED||||||Regression, Linear|||||||0.29
73828994|NCT02814526|147204822|SUPERIORITY||Mean Difference (Net)|0.031||||0.74|TWO_SIDED||||||Regression, Linear|||||||0.74
73828995|NCT02814526|147204823|SUPERIORITY||Mean Difference (Net)|-0.009447||||0.8284|TWO_SIDED||||||Regression, Linear|||||||0.8284
73828996|NCT02814526|147204824|SUPERIORITY||Mean Difference (Net)|-0.02024||||0.7086|TWO_SIDED||||||Regression, Linear|||||||0.7086
73828997|NCT02814526|147204825|SUPERIORITY||Mean Difference (Net)|0.29||||0.06|TWO_SIDED||||||Regression, Linear|||||||0.06
73828998|NCT02814526|147204826|SUPERIORITY||Mean Difference (Net)|-0.17||||0.33|TWO_SIDED||||||Regression, Linear|||||||0.33
73828999|NCT02814526|147204827|SUPERIORITY||Mean Difference (Net)|-0.1||||0.49|TWO_SIDED||||||Regression, Linear|||||||0.49
73829000|NCT02814526|147204828|SUPERIORITY||Mean Difference (Net)|-0.02||||0.61|TWO_SIDED||||||Regression, Linear|||||||0.61
73829001|NCT02814526|147204829|SUPERIORITY||Mean Difference (Net)|-0.01||||0.78|TWO_SIDED||||||Regression, Linear|||||||0.78
73829002|NCT02814526|147204830|SUPERIORITY||Mean Difference (Net)|-0.04||||0.31|TWO_SIDED||||||Regression, Linear|||||||0.31
73829003|NCT02814526|147204831|SUPERIORITY||Mean Difference (Net)|-0.0005||||0.817|TWO_SIDED||||||Regression, Linear|||||||0.817
73829004|NCT02814526|147204832|SUPERIORITY||Mean Difference (Net)|0.002||||0.64|TWO_SIDED||||||Regression, Linear|||||||0.64
73829005|NCT02814526|147204833|SUPERIORITY||Mean Difference (Net)|-0.01||||0.97|TWO_SIDED||||||Regression, Linear|||||||0.97
73829006|NCT02814526|147204834|SUPERIORITY||Mean Difference (Net)|-0.17||||0.94|TWO_SIDED||||||Regression, Linear|||||||0.94
73829007|NCT00251758|147204843|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
73829008|NCT00251758|147204843|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
73829009|NCT00251758|147204843|SUPERIORITY_OR_OTHER|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.15505
73829010|NCT00251758|147204845|SUPERIORITY_OR_OTHER|||||||1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.00001
73829011|NCT00251758|147204845|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
73829012|NCT00251758|147204845|SUPERIORITY_OR_OTHER|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.38740
73829013|NCT01387269|147204847|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis||||< 0.0001
73829014|NCT01387269|147204848|SUPERIORITY_OR_OTHER|||||||0.1475|||||||Wilcoxon rank sum test|||Superiority analysis||||0.1475
73829015|NCT01387269|147204849|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mixed Models Analysis|||Superiority analysis||||0.0004
73829016|NCT01387269|147204850|SUPERIORITY_OR_OTHER|||||||0.0544|||||||Mixed Models Analysis|||Superiority analysis||||0.0544
73829017|NCT01387269|147204851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis||||< 0.0001
73829018|NCT03054428|147204853|SUPERIORITY||percentage difference|22.0|||<|0.0001|TWO_SIDED|95.0|12.2|31.87||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (less than \[\<\] 60 kilogram \[kg\] vs greater than or equal to \[≥\] 60 kg).||31.87|12.2|< 0.0001
73829019|NCT03054428|147204853|SUPERIORITY||percentage difference|15.5|||=|0.0007|TWO_SIDED|95.0|6.7|24.31||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||24.31|6.7|= 0.0007
73829020|NCT03054428|147204854|SUPERIORITY||percentage difference|33.2|||<|0.0001|TWO_SIDED|95.0|21.07|45.39||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||45.39|21.07|< 0.0001
73829021|NCT03054428|147204854|SUPERIORITY||percentage difference|29.9|||<|0.0001|TWO_SIDED|95.0|17.94|41.78||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||41.78|17.94|< 0.0001
73829022|NCT03054428|147204855|SUPERIORITY||Least Square (LS) Mean difference|-42.3|||<|0.0001|TWO_SIDED|95.0|-55.6|-29.04||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-29.04|-55.6|< 0.0001
73829023|NCT03054428|147204855|SUPERIORITY||LS Mean difference|-41.2|||<|0.0001|TWO_SIDED|95.0|-54.44|-28.02||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-28.02|-54.44|< 0.0001
73829024|NCT03054428|147204856|SUPERIORITY||LS Mean difference|-29.0|||<|0.0001|TWO_SIDED|95.0|-39.54|-18.38||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-18.38|-39.54|< 0.0001
73829025|NCT03054428|147204856|SUPERIORITY||LS Mean difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-37.45|15.63||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||15.63|-37.45|< 0.0001
73829026|NCT03054428|147204857|SUPERIORITY||percentage difference|39.4|||<|0.0001|TWO_SIDED|95.0|26.9|51.84||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by CMH test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||51.84|26.9|< 0.0001
73829027|NCT03054428|147204857|SUPERIORITY||percentage difference|29.1|||<|0.0001|TWO_SIDED|95.0|16.97|41.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||41.32|16.97|< 0.0001
73829028|NCT03054428|147204858|SUPERIORITY||Percentage difference|31.8|||<|0.0001|TWO_SIDED|95.0|20.45|43.2||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||43.2|20.45|< 0.0001
73829029|NCT03054428|147204858|SUPERIORITY||Percentage difference|21.7|||=|0.0001|TWO_SIDED|95.0|11.21|32.28||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||32.28|11.21|= 0.0001
73829030|NCT02431299|147204887|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Whether there were significant changes in the IMRS baseline scores to IMRS follow up scores.|t-test, 2 sided|t = 2.78, df = 182||||||<0.01
73829031|NCT02431299|147204888|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||Hypothesized that higher levels of IMR competence would predict higher IMRS outcomes.||||<0.05
73829032|NCT01499810|147204898|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
73829033|NCT01499810|147204900|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
73829034|NCT01499810|147204901|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
73829035|NCT01499810|147204902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
73829036|NCT01499810|147204903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
73829037|NCT01499810|147204904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
73829038|NCT01499810|147204905|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0001
73829039|NCT01499810|147204906|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
73829040|NCT01499810|147204907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.35
73829041|NCT01499810|147204908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.12
73829042|NCT01499810|147204909|SUPERIORITY_OR_OTHER_LEGACY|||||||7e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00007
73829043|NCT01499810|147204910|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00009
73829044|NCT01499810|147204911|SUPERIORITY_OR_OTHER_LEGACY|||||||4e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00004
73829045|NCT01499810|147204912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0001
73829046|NCT01499810|147204913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0007
73829047|NCT01499810|147204914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.001
73829048|NCT01499810|147204915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0004
73829049|NCT01499810|147204916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0002
73829050|NCT01499810|147204917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.57
73829051|NCT01499810|147204918|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.54
73829052|NCT01499810|147204919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.87
73829053|NCT01499810|147204920|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.77
73829054|NCT01499810|147204921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.06
73829055|NCT01499810|147204922|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.07
73829056|NCT01499810|147204923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.32
73829057|NCT01499810|147204924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.12
73829058|NCT01499810|147204925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.72
73829059|NCT01499810|147204926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.37
73829060|NCT01499810|147204927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.99
73829061|NCT01499810|147204928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.76
73829062|NCT01499810|147204929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.08
73829063|NCT01499810|147204930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.35
73829064|NCT01499810|147204931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.22
73829065|NCT01499810|147204932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.29
73829066|NCT01499810|147204933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.89
73829067|NCT01499810|147204934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.65
73829068|NCT01499810|147204935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.76
73829069|NCT01499810|147204936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||Repeated measures analysis|t-test, 2 sided|||Repeated measures analysis||||0.35
73829070|NCT01499810|147204937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.92
73829071|NCT01499810|147204938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.32
73829072|NCT01499810|147204939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.40
73829073|NCT01499810|147204940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.17
73829074|NCT01499810|147204941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.014
73829075|NCT03082729|147204957|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||||||0.612
73829076|NCT03082729|147204958|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
73829077|NCT03082729|147204959|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
73829078|NCT03082729|147204960|SUPERIORITY|||||||0.524|||||||t-test, 2 sided|||||||0.524
73829079|NCT03082729|147204961|SUPERIORITY|||||||0.972|||||||t-test, 2 sided|||||||0.972
73829080|NCT03082729|147204962|SUPERIORITY|||||||0.315|||||||t-test, 2 sided|||||||0.315
73829081|NCT03082729|147204963|SUPERIORITY|||||||0.443|||||||t-test, 2 sided|||||||0.443
73829082|NCT03082729|147204964|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
73829083|NCT03082729|147204965|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.390
73829084|NCT03082729|147204966|SUPERIORITY|||||||0.116|||||||t-test, 2 sided|||||||0.116
73829085|NCT03082729|147204967|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||||||0.331
73829086|NCT03082729|147204968|SUPERIORITY|||||||0.225|||||||t-test, 2 sided|||||||0.225
73829087|NCT03082729|147204969|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
73829088|NCT03082729|147204970|SUPERIORITY|||||||0.882|||||||t-test, 2 sided|||||||0.882
73829089|NCT03082729|147204971|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||0.326
73829090|NCT03082729|147204972|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
73829091|NCT03082729|147204973|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
73829092|NCT03082729|147204974|SUPERIORITY|||||||0.771|||||||t-test, 2 sided|||||||0.771
73829093|NCT03082729|147204975|SUPERIORITY|||||||0.491|||||||t-test, 2 sided|||||||0.491
73829094|NCT03082729|147204976|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||||||0.924
73829095|NCT03082729|147204977|SUPERIORITY|||||||0.868|||||||t-test, 2 sided|||||||0.868
73829096|NCT03082729|147204978|SUPERIORITY|||||||0.922|||||||t-test, 2 sided|||||||0.922
73829097|NCT03082729|147204979|SUPERIORITY|||||||0.192|||||||t-test, 2 sided|||||||0.192
73829098|NCT03082729|147204980|SUPERIORITY|||||||0.453|||||||t-test, 2 sided|||||||0.453
73829099|NCT03082729|147204981|SUPERIORITY|||||||0.714|||||||t-test, 2 sided|||||||0.714
73829100|NCT03082729|147204982|SUPERIORITY|||||||0.434|||||||t-test, 2 sided|||||||0.434
73829101|NCT03082729|147204983|SUPERIORITY|||||||0.329|||||||t-test, 2 sided|||||||0.329
73829102|NCT03082729|147204984|SUPERIORITY|||||||0.963|||||||t-test, 2 sided|||||||0.963
73829103|NCT03082729|147204985|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.400
73829104|NCT03082729|147204986|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||||||0.223
73829105|NCT03082729|147204987|SUPERIORITY|||||||0.241|||||||t-test, 2 sided|||||||0.241
73829106|NCT03082729|147204988|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||||||0.348
73829107|NCT03082729|147204989|SUPERIORITY|||||||0.424|||||||t-test, 2 sided|||||||0.424
73829108|NCT03082729|147204990|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
73829109|NCT03082729|147204991|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||||||0.135
73829110|NCT03082729|147204992|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||||||0.331
73829111|NCT03082729|147204993|SUPERIORITY|||||||0.538|||||||t-test, 2 sided|||||||0.538
73829112|NCT03082729|147204994|SUPERIORITY|||||||0.791|||||||t-test, 2 sided|||||||0.791
73829113|NCT03082729|147204995|SUPERIORITY|||||||0.925|||||||t-test, 2 sided|||||||0.925
73829114|NCT03082729|147204996|SUPERIORITY|||||||0.161|||||||t-test, 2 sided|||||||0.161
73829115|NCT03082729|147204997|SUPERIORITY|||||||0.546|||||||t-test, 2 sided|||||||0.546
73829116|NCT03082729|147204998|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
73829117|NCT03082729|147204999|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.840
73829118|NCT03082729|147205000|SUPERIORITY|||||||0.367|||||||t-test, 2 sided|||||||0.367
73829119|NCT03082729|147205001|SUPERIORITY|||||||0.773|||||||t-test, 2 sided|||||||0.773
73829120|NCT03082729|147205002|SUPERIORITY|||||||0.968|||||||t-test, 2 sided|||||||0.968
73829121|NCT03082729|147205003|SUPERIORITY|||||||0.953|||||||t-test, 2 sided|||||||0.953
73829122|NCT03082729|147205004|SUPERIORITY|||||||0.911|||||||t-test, 2 sided|||||||0.911
73829123|NCT03082729|147205005|SUPERIORITY|||||||0.944|||||||t-test, 2 sided|||||||0.944
73829124|NCT03082729|147205006|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||||||0.226
73829125|NCT03082729|147205007|SUPERIORITY|||||||0.988|||||||t-test, 2 sided|||||||0.988
73829126|NCT03082729|147205008|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
73829127|NCT03082729|147205009|SUPERIORITY|||||||0.488|||||||t-test, 2 sided|||||||0.488
73829128|NCT03082729|147205010|SUPERIORITY|||||||0.523|||||||t-test, 2 sided|||||||0.523
73829129|NCT03082729|147205011|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.060
73829130|NCT03082729|147205012|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
73829131|NCT03082729|147205013|SUPERIORITY|||||||0.946|||||||t-test, 2 sided|||||||0.946
73829132|NCT03082729|147205014|SUPERIORITY|||||||0.351|||||||t-test, 2 sided|||||||0.351
73829133|NCT03082729|147205015|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|||||||0.041
73829134|NCT03082729|147205016|SUPERIORITY|||||||0.884|||||||t-test, 2 sided|||||||0.884
73829135|NCT03082729|147205017|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
73829136|NCT03082729|147205018|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
73829137|NCT03082729|147205019|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
73829138|NCT03082729|147205020|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||||||0.283
73829139|NCT03082729|147205021|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
73829140|NCT03082729|147205022|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||0.371
73829141|NCT03082729|147205023|SUPERIORITY|||||||0.555|||||||t-test, 2 sided|||||||0.555
73829142|NCT03082729|147205024|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||||||0.533
73829143|NCT03082729|147205025|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|||||||0.137
73829144|NCT03082729|147205026|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73829145|NCT03082729|147205026|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
73829146|NCT03082729|147205026|SUPERIORITY|||||||0.537|||||||t-test, 2 sided|||||||0.537
73829147|NCT03082729|147205027|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
73829148|NCT03082729|147205027|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
73829149|NCT03082729|147205027|SUPERIORITY|||||||0.918|||||||t-test, 2 sided|||||||0.918
73829150|NCT03082729|147205028|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73829151|NCT03082729|147205028|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73829152|NCT03082729|147205029|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73829153|NCT03082729|147205029|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73829154|NCT03082729|147205030|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73829155|NCT03082729|147205030|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73829156|NCT03082729|147205031|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73829157|NCT03082729|147205031|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
73829158|NCT03082729|147205033|SUPERIORITY|||||||0.092|||||||t-test, 2 sided|||||||0.092
73829159|NCT03082729|147205033|SUPERIORITY|||||||0.678|||||||t-test, 2 sided|||||||0.678
73829160|NCT03082729|147205034|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
73829161|NCT03082729|147205034|SUPERIORITY|||||||0.762|||||||t-test, 2 sided|||||||0.762
73829162|NCT03082729|147205035|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||||||0.973
73829163|NCT03082729|147205035|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|||||||0.805
73829164|NCT03082729|147205036|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||||||0.951
73829165|NCT03082729|147205036|SUPERIORITY|||||||0.661|||||||t-test, 2 sided|||||||0.661
73829166|NCT03082729|147205037|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
73829167|NCT03082729|147205037|SUPERIORITY|||||||0.306|||||||t-test, 2 sided|||||||0.306
73829168|NCT03082729|147205038|SUPERIORITY|||||||0.322|||||||t-test, 2 sided|||||||0.322
73829169|NCT03082729|147205038|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
73829170|NCT03082729|147205039|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.960
73829171|NCT03082729|147205039|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||||||0.268
73829172|NCT03082729|147205040|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||||||0.501
73829173|NCT03082729|147205040|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||||||0.235
73829174|NCT03082729|147205041|SUPERIORITY|||||||0.259|||||||t-test, 2 sided|||||||0.259
73829175|NCT03082729|147205041|SUPERIORITY|||||||0.219|||||||t-test, 2 sided|||||||0.219
73829176|NCT03082729|147205042|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.140
73829177|NCT03082729|147205042|SUPERIORITY|||||||0.633|||||||t-test, 2 sided|||||||0.633
73829178|NCT03082729|147205043|SUPERIORITY|||||||0.302|||||||t-test, 2 sided|||||||0.302
73829179|NCT03082729|147205043|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
73829180|NCT03082729|147205044|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
73829181|NCT03082729|147205044|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||||||0.324
73829182|NCT03082729|147205045|SUPERIORITY|||||||0.812|||||||t-test, 2 sided|||||||0.812
73829183|NCT03082729|147205045|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|||||||0.264
73829184|NCT03082729|147205046|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||||||0.283
73829185|NCT03082729|147205046|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.250
73829186|NCT03082729|147205047|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
73829187|NCT03082729|147205047|SUPERIORITY|||||||0.249|||||||t-test, 2 sided|||||||0.249
73829188|NCT03082729|147205048|SUPERIORITY|||||||0.526|||||||t-test, 2 sided|||||||0.526
73829189|NCT03082729|147205048|SUPERIORITY|||||||0.632|||||||t-test, 2 sided|||||||0.632
73829190|NCT03082729|147205049|SUPERIORITY|||||||0.584|||||||t-test, 2 sided|||||||0.584
73829191|NCT03082729|147205049|SUPERIORITY|||||||0.191|||||||t-test, 2 sided|||||||0.191
73829192|NCT03082729|147205050|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
73829193|NCT03082729|147205050|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
73829194|NCT03082729|147205051|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||||||0.533
73829195|NCT03082729|147205051|SUPERIORITY|||||||0.079|||||||t-test, 2 sided|||||||0.079
73829196|NCT03082729|147205052|SUPERIORITY|||||||0.338|||||||t-test, 2 sided|||||||0.338
73829197|NCT03082729|147205052|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||0.091
73829198|NCT03082729|147205053|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||||||0.102
73829199|NCT03082729|147205053|SUPERIORITY|||||||0.153|||||||t-test, 2 sided|||||||0.153
73829200|NCT03082729|147205054|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||||||0.226
73829201|NCT03082729|147205054|SUPERIORITY|||||||0.222|||||||t-test, 2 sided|||||||0.222
73829202|NCT03082729|147205055|SUPERIORITY|||||||0.384|||||||t-test, 2 sided|||||||0.384
73829203|NCT03082729|147205055|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||||||0.112
73829204|NCT03082729|147205056|SUPERIORITY|||||||0.636|||||||t-test, 2 sided|||||||0.636
73829205|NCT03082729|147205056|SUPERIORITY|||||||0.896|||||||t-test, 2 sided|||||||0.896
73829206|NCT03082729|147205057|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.800
73829207|NCT03082729|147205057|SUPERIORITY|||||||0.551|||||||t-test, 2 sided|||||||0.551
73829208|NCT03082729|147205058|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.440
73829209|NCT03082729|147205058|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
73829210|NCT03082729|147205059|SUPERIORITY|||||||0.278|||||||t-test, 2 sided|||||||0.278
73829211|NCT03082729|147205059|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
73829212|NCT03082729|147205060|SUPERIORITY|||||||0.795|||||||t-test, 2 sided|||||||0.795
73829213|NCT03082729|147205060|SUPERIORITY|||||||0.284|||||||t-test, 2 sided|||||||0.284
73829214|NCT03082729|147205061|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.880
73829215|NCT03082729|147205061|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||||||0.028
73829216|NCT03082729|147205062|SUPERIORITY|||||||0.746|||||||t-test, 2 sided|||||||0.746
73829217|NCT03082729|147205062|SUPERIORITY|||||||0.199|||||||t-test, 2 sided|||||||0.199
73829218|NCT03082729|147205063|SUPERIORITY|||||||0.814|||||||t-test, 2 sided|||||||0.814
73829219|NCT03082729|147205063|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
73829220|NCT03082729|147205064|SUPERIORITY|||||||0.494|||||||t-test, 2 sided|||||||0.494
73829221|NCT03082729|147205064|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.960
73829222|NCT03082729|147205065|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
73829223|NCT03082729|147205065|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||||||0.028
73829224|NCT03082729|147205066|SUPERIORITY|||||||0.241|||||||t-test, 2 sided|||||||0.241
73829225|NCT03082729|147205066|SUPERIORITY|||||||0.869|||||||t-test, 2 sided|||||||0.869
73829226|NCT03082729|147205067|SUPERIORITY|||||||0.977|||||||t-test, 2 sided|||||||0.977
73829227|NCT03082729|147205067|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
73829228|NCT03082729|147205068|SUPERIORITY|||||||0.591|||||||t-test, 2 sided|||||||0.591
73829229|NCT03082729|147205068|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
73829230|NCT03082729|147205069|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.260
73829231|NCT03082729|147205069|SUPERIORITY|||||||0.526|||||||t-test, 2 sided|||||||0.526
73829232|NCT03082729|147205070|SUPERIORITY|||||||0.545|||||||t-test, 2 sided|||||||0.545
73829233|NCT03082729|147205070|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||||||0.690
73829234|NCT03082729|147205071|SUPERIORITY|||||||0.542|||||||t-test, 2 sided|||||||0.542
73829235|NCT03082729|147205071|SUPERIORITY|||||||0.344|||||||t-test, 2 sided|||||||0.344
73829236|NCT03082729|147205072|SUPERIORITY|||||||0.918|||||||t-test, 2 sided|||||||0.918
73829237|NCT03082729|147205072|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
73829238|NCT03082729|147205073|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.510
73829239|NCT03082729|147205073|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||||||0.516
73829240|NCT03082729|147205074|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
73829241|NCT03082729|147205074|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
73829242|NCT03082729|147205075|SUPERIORITY|||||||0.392|||||||t-test, 2 sided|||||||0.392
73829243|NCT03082729|147205075|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||||||0.177
73829244|NCT03082729|147205076|SUPERIORITY|||||||0.584|||||||t-test, 2 sided|||||||0.584
73829245|NCT03082729|147205076|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
73829246|NCT03082729|147205077|SUPERIORITY|||||||0.421|||||||t-test, 2 sided|||||||0.421
73829247|NCT03082729|147205077|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||||||0.145
73829248|NCT03082729|147205078|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
73829249|NCT03082729|147205078|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||||||0.345
73829250|NCT03082729|147205079|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|||||||0.957
73829251|NCT03082729|147205079|SUPERIORITY|||||||0.425|||||||t-test, 2 sided|||||||0.425
73829252|NCT03082729|147205080|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||||||0.698
73829253|NCT03082729|147205080|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||||||0.709
73829254|NCT03082729|147205081|SUPERIORITY|||||||0.362|||||||t-test, 2 sided|||||||0.362
73829255|NCT03082729|147205081|SUPERIORITY|||||||0.221|||||||t-test, 2 sided|||||||0.221
73829256|NCT03082729|147205082|SUPERIORITY|||||||0.813|||||||t-test, 2 sided|||||||0.813
73829257|NCT03082729|147205082|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
73829258|NCT03082729|147205083|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||||||0.752
73829259|NCT03082729|147205083|SUPERIORITY|||||||0.808|||||||t-test, 2 sided|||||||0.808
73829260|NCT03082729|147205084|SUPERIORITY|||||||0.251|||||||t-test, 2 sided|||||||0.251
73829261|NCT03082729|147205084|SUPERIORITY|||||||0.329|||||||t-test, 2 sided|||||||0.329
73829262|NCT03082729|147205085|SUPERIORITY|||||||0.215|||||||t-test, 2 sided|||||||0.215
73829263|NCT03082729|147205085|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||||||0.612
73829264|NCT03082729|147205086|SUPERIORITY|||||||0.307|||||||t-test, 2 sided|||||||0.307
73829265|NCT03082729|147205086|SUPERIORITY|||||||0.686|||||||t-test, 2 sided|||||||0.686
73829266|NCT03082729|147205087|SUPERIORITY|||||||0.139|||||||t-test, 2 sided|||||||0.139
73829267|NCT03082729|147205087|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.350
73829268|NCT03082729|147205088|SUPERIORITY|||||||0.721|||||||t-test, 2 sided|||||||0.721
73829269|NCT03082729|147205088|SUPERIORITY|||||||0.285|||||||t-test, 2 sided|||||||0.285
73829270|NCT03082729|147205089|SUPERIORITY|||||||0.804|||||||t-test, 2 sided|||||||0.804
73829271|NCT03082729|147205089|SUPERIORITY|||||||0.793|||||||t-test, 2 sided|||||||0.793
73829272|NCT03082729|147205090|SUPERIORITY|||||||0.293|||||||t-test, 2 sided|||||||0.293
73829273|NCT03082729|147205090|SUPERIORITY|||||||0.355|||||||t-test, 2 sided|||||||0.355
73829274|NCT03082729|147205091|SUPERIORITY|||||||0.101|||||||t-test, 2 sided|||||||0.101
73829275|NCT03082729|147205091|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
73829276|NCT03082729|147205092|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|||||||0.137
73829277|NCT03082729|147205092|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
73829278|NCT03082729|147205093|SUPERIORITY|||||||0.115|||||||t-test, 2 sided|||||||0.115
73829279|NCT03082729|147205093|SUPERIORITY|||||||0.378|||||||t-test, 2 sided|||||||0.378
73829280|NCT03082729|147205094|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||0.122
73829281|NCT03082729|147205094|SUPERIORITY|||||||0.815|||||||t-test, 2 sided|||||||0.815
73829282|NCT03082729|147205095|SUPERIORITY|||||||0.321|||||||t-test, 2 sided|||||||0.321
73829283|NCT03082729|147205095|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
73829284|NCT03082729|147205096|SUPERIORITY|||||||0.352|||||||t-test, 2 sided|||||||0.352
73829285|NCT03082729|147205096|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.180
73829286|NCT03082729|147205097|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
73829287|NCT03082729|147205097|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||||||0.383
73829288|NCT03082729|147205098|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
73829289|NCT03082729|147205098|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
73829290|NCT03082729|147205099|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
73829291|NCT03082729|147205099|SUPERIORITY|||||||0.208|||||||t-test, 2 sided|||||||0.208
73829292|NCT03082729|147205100|SUPERIORITY|||||||0.446|||||||t-test, 2 sided|||||||0.446
73829293|NCT03082729|147205100|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
73829294|NCT03082729|147205101|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
73829295|NCT03082729|147205101|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
73829296|NCT05471505|147205102|OTHER||Hazard Ratio (HR)|0.752|||<|0.001|TWO_SIDED|95.0|0.719|0.787|||COX Proportional Hazards Regression|||||0.787|0.719|<0.001
73829297|NCT05471505|147205103|OTHER||Hazard Ratio (HR)|0.747|||<|0.001|TWO_SIDED|95.0|0.687|0.813|||COX Proportional Hazards Regression|||||0.813|0.687|<0.001
73829298|NCT05471505|147205104|OTHER||Hazard Ratio (HR)|0.909|||<|0.001|TWO_SIDED|95.0|0.862|0.958|||COX Proportional Hazards Regression|||||0.958|0.862|<0.001
73829299|NCT05471505|147205105|OTHER||Hazard Ratio (HR)|0.948||||0.378|TWO_SIDED|95.0|0.842|1.067|||COX Proportional Hazards Regression|||||1.067|0.842|0.378
73829300|NCT05471505|147205106|OTHER||Hazard Ratio (HR)|0.259|||<|0.001|TWO_SIDED|95.0|0.229|0.294|||COX Proportional Hazards Regression|||||0.294|0.229|<0.001
73829301|NCT05471505|147205107|OTHER||Hazard Ratio (HR)|0.767|||<|0.001|TWO_SIDED|95.0|0.7|0.84|||COX Proportional Hazards Regression|||||0.840|0.700|<0.001
73829302|NCT05471505|147205108|OTHER||Hazard Ratio (HR)|0.932||||0.022|TWO_SIDED|95.0|0.877|0.99|||COX Proportional Hazards Regression|||||0.990|0.877|0.022
73829303|NCT03353220|147205145|OTHER|||||||0.65||||||paired t test|t-test, 2 sided|||||||0.65
73829304|NCT03353220|147205146|OTHER|||||||0.0001||||||paired t test|t-test, 2 sided|||||||0.0001
73829305|NCT03353220|147205147|OTHER|||||||0.0017||||||paired t test|t-test, 2 sided|||||||0.0017
73829306|NCT03353220|147205151|OTHER|||||||0.0189|||||||t-test, 2 sided|||||||0.0189
73829307|NCT04596293|147205180|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73829308|NCT04596293|147205180|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73829309|NCT04596293|147205181|OTHER|||||||0.6351|||||||Fisher Exact|||||||0.6351
73829310|NCT04596293|147205181|OTHER|||||||0.3108|||||||Fisher Exact|||||||0.3108
73829311|NCT04596293|147205182|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
73829312|NCT04596293|147205182|OTHER|||||||0.6594|||||||Fisher Exact|||||||0.6594
73829313|NCT04596293|147205183|OTHER|||||||0.5808|||||||ANCOVA|||||||0.5808
73829314|NCT04596293|147205183|OTHER|||||||0.2143|||||||ANCOVA|||||||0.2143
73829315|NCT00336544|147205184|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-5.7||||0.0769||95.0|-11.9|0.6|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||0.6|-11.9|0.0769
73896542|NCT03456882|147326408|SUPERIORITY||difference between mean slopes|0.09|STANDARD_ERROR_OF_MEAN|0.18||0.5924|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the off-treatment follow-up period (change per week, from week 24 to week 48) between treatment groups. Null hypothesis: the rate of change from week 24 to week 48 is not different between groups.||||0.5924
73829316|NCT00336544|147205186|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-4.4||||0.0775||95.0|-9.1|0.3|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||0.3|-9.1|0.0775
73829317|NCT01649765|147205188|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.64|3.46||||||||3.46|0.64|
73829318|NCT01649765|147205189|SUPERIORITY||Odds Ratio (OR)|2.74|||||TWO_SIDED|95.0|1.15|6.54|||||Definition 1|||6.54|1.15|
73829319|NCT01649765|147205189|SUPERIORITY||Odds Ratio (OR)|2.92|||||TWO_SIDED|95.0|1.19|7.17|||||Definition 2|||7.17|1.19|
73829320|NCT00316004|147205229|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.||||0.55
73829321|NCT00316004|147205230|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥4.||||0.59
73829322|NCT00316004|147205231|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations.||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.||||0.67
73829323|NCT00316004|147205232|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥2.||||0.57
73829324|NCT00316004|147205233|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent of patients at any level of disability between the three groups.||||.84
73829325|NCT00316004|147205234|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the 28th day after injury between the three groups.||||0.88
73829326|NCT00316004|147205235|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the day discharged from the hospital after injury between the three groups.||||0.88
73829327|NCT00316004|147205236|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive and free of ARDS from the day of injury to the 28th day after injury between the three groups.||||0.91
73829328|NCT00316004|147205237|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.||||0.81
73829329|NCT00316004|147205238|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.||||0.77
73829330|NCT00316004|147205239|SUPERIORITY_OR_OTHER|||||||0.76||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the ICU through day 28 between the three groups.||||0.76
73829331|NCT00316004|147205240|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the hospital through day 28 between the three groups.||||0.43
73829332|NCT00316004|147205241|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with any nosocomial infections through hospital stay between the three groups.||||0.06
73829333|NCT00316004|147205241|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with pneumonia through hospital stay between the three groups.||||0.3
73829334|NCT00316004|147205241|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with bloodstream infections through hospital stay between the three groups.||||0.04
73829335|NCT00316004|147205241|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with urinary tract infections through hospital stay between the three groups.||||0.06
73829336|NCT00316004|147205241|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with wound infections through hospital stay between the three groups.||||0.88
73829337|NCT00316004|147205242|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of total fluids given within the first 24 hours between the three groups.||||0.68
73829338|NCT00316004|147205243|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.||||0.43
73829339|NCT00316004|147205244|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died during hospitalization between the three groups.||||0.88
73829340|NCT00316004|147205244|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to home between the three groups.||||0.26
73829341|NCT00316004|147205244|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to inpatient rehabilitation facilities between the three groups.||||0.16
73829342|NCT00316004|147205244|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to skilled nursing facilities between the three groups.||||0.17
73829343|NCT02202252|147205245|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.490
73829344|NCT02202252|147205246|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Chi-squared|||||||0.035
73829345|NCT02202252|147205247|SUPERIORITY_OR_OTHER|||||||0.819|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.819
73829346|NCT01944423|147205276|SUPERIORITY||Logit difference (final values)|0.64|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.25|0.97||p=ns 2-sided|two-phase growth curve model|||||0.97|-2.25|
73829347|NCT01944423|147205277|SUPERIORITY||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|1.87||0.038|TWO_SIDED|95.0|0.25|7.94||2-sided|two-phase growth curve model|||At end-of-treatment||7.94|0.25|.038
73829348|NCT01944423|147205278|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|1.0||0.003|TWO_SIDED|95.0|1.15|5.26||2-sided|two-phase growth curve model|||At 6 month follow-up||5.26|1.15|.003
73829349|NCT01829347|147205279|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.076|TWO_SIDED|95.0|0.085|1.133|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-Treat (ITT) population utilizing a log-rank test.||1.133|0.085|0.076
73829350|NCT01829347|147205280|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
73829351|NCT02309359|147205344|OTHER|Under the assumption of monotonicity, a Cochran-Armitage trend test was performed as the primary efficacy analysis. Data were analyzed according to the intent-to-treat (ITT) principle; thus, subjects were analyzed according to the treatment to which they were assigned. Subjects with missing ACR20 response at Week 12 were treated as non responders (non responder imputation approach).||||||0.172|||||||Cochran-Armitage trend test|||The null hypothesis of this test was that there is no difference in the percentage of subjects achieving ACR20 response between the treatment groups and the alternative hypothesis was that the percentage of subjects achieving ACR20 response increases with increasing dose level.||||0.172
73829352|NCT00284856|147205412|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.92||||||95.0|0.28|11.56|||||Estimated Value is difference in least squares mean (montelukast - placebo)|||11.56|0.28|
73829353|NCT00284856|147205412|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|10.14||||||95.0|4.5|15.78|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||15.78|4.50|
73829354|NCT00284856|147205412|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.22||||||95.0|-9.83|1.38|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||1.38|-9.83|
73829355|NCT00284856|147205413|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.15||||||95.0|-0.25|-0.05|||||Estimated value is difference in least squares mean (montelukast - placebo)|||-0.05|-0.25|
73829356|NCT00284856|147205413|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2||||||95.0|-0.3|-0.1|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||-0.10|-0.30|
73829357|NCT00284856|147205413|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.05||||||95.0|-0.05|0.15|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||0.15|-0.05|
73829358|NCT00284856|147205414|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.09||||||95.0|-1.27|11.45|||||Estimated value is difference in least squares mean (montelukast - placebo)|||11.45|-1.27|
73829359|NCT00284856|147205414|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|11.21||||||95.0|4.85|17.58|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||17.58|4.85|
73829360|NCT00284856|147205414|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-6.13||||||95.0|-12.46|0.2|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||0.20|-12.46|
73829361|NCT01394276|147205423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0237|||||||Exact binomial proportion test|||||||0.0237
73829362|NCT01394276|147205424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Exact binomial proportion test|||||||0.0003
73829363|NCT01394276|147205436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.808|TWO_SIDED|95.0|-0.3|0.4|||t-test, 2 sided|||At Baseline: mean difference of scores of DAS28 between the two groups was calculated.||0.4|-0.3|0.8080
73829364|NCT01394276|147205436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.4884|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||At Month 1: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.5|0.4884
73829365|NCT01394276|147205436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.3||||0.0947|TWO_SIDED|95.0|-0.7|0.1|||t-test, 2 sided|||At Month 2: mean difference of scores of DAS28 between the two groups was calculated.||0.1|-0.7|0.0947
73829366|NCT01394276|147205436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.8181|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 4: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.4|0.8181
73829367|NCT01394276|147205436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9721|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 6: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.4|0.9721
73829368|NCT01394276|147205436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.5832|TWO_SIDED|95.0|-0.3|0.5|||t-test, 2 sided|||At Month 12: mean difference of scores of DAS28 between the two groups was calculated.||0.5|-0.3|0.5832
73829369|NCT01394276|147205437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.5||||0.4211|TWO_SIDED|95.0|-5.1|12.2|||t-test, 2 sided|||At Baseline: mean difference of scores of fatigue between the two groups was calculated.||12.2|-5.1|0.4211
73829370|NCT01394276|147205437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.1||||0.6749|TWO_SIDED|95.0|-7.9|12.1|||t-test, 2 sided|||At Month 1: mean difference of scores of fatigue between the two groups was calculated.||12.1|-7.9|0.6749
73829371|NCT01394276|147205437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.4||||0.1817|TWO_SIDED|95.0|-3.0|15.9|||t-test, 2 sided|||At Month 2: mean difference of scores of fatigue between the two groups was calculated.||15.9|-3.0|0.1817
73829372|NCT01394276|147205437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.8||||0.5182|TWO_SIDED|95.0|-5.8|11.4|||t-test, 2 sided|||At Month 4: mean difference of scores of fatigue between the two groups was calculated.||11.4|-5.8|0.5182
73829373|NCT01394276|147205437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.7||||0.0025|TWO_SIDED|95.0|4.9|22.6|||t-test, 2 sided|||At Month 6: mean difference of scores of fatigue between the two groups was calculated.||22.6|4.9|0.0025
73829374|NCT01394276|147205437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.9||||0.354|TWO_SIDED|95.0|-4.4|12.1|||t-test, 2 sided|||At Month 12: mean difference of scores of fatigue between the two groups was calculated.||12.1|-4.4|0.3540
73829375|NCT01394276|147205438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.7343|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||At Baseline: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.2|0.7343
73829376|NCT01394276|147205438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.1098|TWO_SIDED|95.0|-0.4|0.0|||t-test, 2 sided|||At Month 1: mean difference of scores of HAQ between the two groups was calculated.||0.0|-0.4|0.1098
73829377|NCT01394276|147205438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.4932|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||At Month 2: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.3|0.4932
73829378|NCT01394276|147205438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.2468|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided|||At Month 4: mean difference of scores of HAQ between the two groups was calculated.||0.1|-0.4|0.2468
73829379|NCT01394276|147205438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9639|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||At Month 6: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.2|0.9639
73829380|NCT01394276|147205438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.6696|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||At Month 12: mean difference of scores of HAQ between the two groups was calculated.||0.3|-0.2|0.6696
73829381|NCT00560404|147205451|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean Hb within target range during efficacy evaluation period within plus or minus 1 g/dL of their reference Hb and between the target range with a non-inferiority limit of -0.15.|Difference of response rates|-0.02|||||TWO_SIDED|95.0|-0.25|0.2||||||||0.20|-0.25|
73829382|NCT00471497|147205476|OTHER||Difference in response rate|22.1|||<|0.0001|TWO_SIDED|95.0|14.5|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.5|<0.0001
73829383|NCT00471497|147205476|OTHER||Difference in response rate|20.4|||<|0.0001|TWO_SIDED|95.0|12.9|28.0|||Cochran-Mantel-Haenszel|||||28.0|12.9|<0.0001
73829384|NCT00471497|147205477|OTHER||Difference in response rate|14.8|||||TWO_SIDED|95.0|2.1|27.5||||||(Low)||27.5|2.1|
73829385|NCT00471497|147205477|OTHER||Difference in response rate|27.4|||||TWO_SIDED|95.0|14.6|40.2||||||(Low)||40.2|14.6|
73829386|NCT00471497|147205477|OTHER||Difference in response rate|27.7|||||TWO_SIDED|95.0|15.0|40.4||||||(Intermediate)||40.4|15.0|
73829387|NCT00471497|147205477|OTHER||Difference in response rate|17.2|||||TWO_SIDED|95.0|4.6|29.8||||||(Intermediate)||29.8|4.6|
73829388|NCT00471497|147205477|OTHER||Difference in response rate|24.4|||||TWO_SIDED|95.0|10.7|38.1||||||(High)||38.1|10.7|
73829389|NCT00471497|147205477|OTHER||Difference in response rate|15.4|||||TWO_SIDED|95.0|2.1|28.6||||||(High)||28.6|2.1|
73829390|NCT00471497|147205478|OTHER||Difference in response rate|21.3|||||TWO_SIDED|95.0|13.9|28.8||||||||28.8|13.9|
73829391|NCT00471497|147205478|OTHER||Difference in response rate|18.7|||||TWO_SIDED|95.0|11.3|26.0||||||||26.0|11.3|
73829392|NCT00471497|147205480|OTHER||Absolute difference|-1.6||||0.6987|TWO_SIDED|95.0|-9.8|6.6|||Cochran-Mantel-Haenszel|||||6.6|-9.8|0.6987
73896543|NCT03456882|147326409|SUPERIORITY|||||||0.9598||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 4 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 4 weeks is not different between groups||||0.9598
73896544|NCT03456882|147326409|SUPERIORITY|||||||0.939||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 12 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 12 weeks is not different between groups||||0.9390
73829393|NCT00392223|147205507|NON_INFERIORITY_OR_EQUIVALENCE|Analysis performed to assess non-inferiority by calculation \& examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.47||||||95.0|-2.48|1.54|||||Comparison between treatment groups was performed using an analysis of covariance (ANCOVA) method, with treatment, center, and baseline value GAGS global score included as covariates.|||1.54|-2.48|
73829394|NCT00392223|147205511|NON_INFERIORITY_OR_EQUIVALENCE|Analysis performed to assess non-inferiority by calculation \& examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.87||||||95.0|-2.58|0.84|||||ANCOVA adjusted for baseline, center and treatment.|||0.84|-2.58|
73829395|NCT00402831|147205521|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.5|2.6||||||Measles difference||2.6|-2.5|
73829396|NCT00402831|147205521|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-3.0|3.3||||||Mumps difference||3.3|-3.0|
73829397|NCT00402831|147205521|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.3|4.1||||||Rubella difference||4.1|-2.3|
73829398|NCT00402831|147205521|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.1|4.1||||||Varicella||4.1|-2.1|
73829399|NCT03043053|147205534|OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-1.4|1.3||||||||1.3|-1.4|
73829400|NCT03043053|147205535|OTHER||Mean Difference (Final Values)|-29.7|||||TWO_SIDED|95.0|-141.9|82.6|||||Controlled for lean mass. Reported values are outputted by STATA.|||82.6|-141.9|
73829401|NCT03043053|147205536|OTHER||Mean Difference (Final Values)|196.0|||||TWO_SIDED|95.0|-1036.0|1428.0||||||||1428|-1036|
73829402|NCT03043053|147205537|OTHER||Mean Difference (Final Values)|-152.0|||||TWO_SIDED|95.0|-302.3|-1.7||||||||-1.7|-302.3|
73829403|NCT01981616|147205559|NON_INFERIORITY_OR_EQUIVALENCE|"With 55 evaluable participants in each group, the study would have at least 80% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% confidence interval (CI) on the difference in proportions between vedolizumab- and placebo-treated participants, assuming a 90% seroconversion rate (anti-HBs of 10 IU/L) for hepatitis B vaccine.~If the lower bound of this interval was less than -15% (ie, more negative), then the null hypothesis was accepted."|Difference from placebo|-1.8|||||TWO_SIDED|95.0|-12.7|9.1||||||||9.1|-12.7|
73829404|NCT01981616|147205560|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 55 evaluable subjects in the vedolizumab 750 mg IV group and 55 evaluable participants in the placebo group provided at least 71% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% CI on the difference in proportions between vedolizumab- and placebo-treated participants, assuming an 85% seroconversion rate to the oral cholera vaccine (Dukoral).|Difference from placebo|-14.2|||||TWO_SIDED|95.0|-24.6|-3.9||||||||-3.9|-24.6|
73829405|NCT01141608|147205594|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Linear mixed effects model|||||||<0.05
73829406|NCT02753881|147205621|OTHER|||||||0.036||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicin.||||.036
73829407|NCT02753881|147205621|OTHER|||||||0.002||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicinol.||||0.002
73829408|NCT02753881|147205623|OTHER|||||||0.023||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicin.||||0.023
73829409|NCT02753881|147205623|OTHER|||||||0.041||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicinol.||||0.041
73829410|NCT00506675|147205628|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|95.0|||||ANCOVA|||||||0.30
73829411|NCT00506675|147205629|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANCOVA|||||||0.30
73829412|NCT00506675|147205630|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|95.0|||||ANCOVA|||||||0.30
73829413|NCT02858908|147205636|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.6696||||0.0484|TWO_SIDED|95.0|-1.334|-0.0051|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete 10-metre walk/run test at the preferred speed||-0.0051|-1.3340|0.0484
73829414|NCT02858908|147205636|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.6449||||0.0565|TWO_SIDED|95.0|-1.3094|0.0195|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete 10-metre walk/run test at the preferred speed||0.0195|-1.3094|0.0565
73829415|NCT02858908|147205637|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|0.9102||||0.3732|TWO_SIDED|95.0|-1.1526|2.973|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in grip strength (kg)||2.9730|-1.1526|0.3732
73829416|NCT02858908|147205637|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.3897||||0.1782|TWO_SIDED|95.0|-3.4525|0.6731|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in grip strength (kg)||0.6731|-3.4525|0.1782
73829417|NCT02858908|147205638|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.0213||||0.8886|TWO_SIDED|95.0|-0.3368|0.2941|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in FVC (litres)||0.2941|-0.3368|0.8886
73829418|NCT02858908|147205638|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|0.0152||||0.9204|TWO_SIDED|95.0|-0.3003|0.3307|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in FVC (litres)||0.3307|-0.3003|0.9204
73829419|NCT02858908|147205639|OTHER|The exact Wilcoxon signed rank test was used to test for a change in the DXA scan total lean muscle mass (g) from baseline to end of treatment|Median Difference (Net)|-42.75||||1|TWO_SIDED|95.0|-1270.0|2178.5|||ANCOVA||Hodges-Lehmann estimates for the median and confidence intervals are presented|Changes from baseline to week 12 in the DXA scan total lean muscle mass (g)||2178.50|-1270.00|1.0000
73829420|NCT02858908|147205639|OTHER|The exact Wilcoxon signed rank test was used to test for a change in the DXA scan total lean muscle mass (g) from baseline to end of treatment|Median Difference (Net)|426.75||||0.3125|TWO_SIDED|95.0|-289.5|1198.5|||ANCOVA||Hodges-Lehmann estimates for the median and confidence intervals are presented|Changes from baseline to week 12 in the DXA scan total lean muscle mass (g)||1198.50|-289.50|0.3125
73829421|NCT02858908|147205641|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom.|Mean Difference (Net)|3.1||||0.003|TWO_SIDED|95.0|2.6|3.7||The p-value is presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in Clinical Global Impression Global Improvement Scale (CGI-I)||3.7|2.6|0.0030
73829422|NCT02858908|147205641|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom.|Mean Difference (Net)|3.0||||0.0009|TWO_SIDED|95.0|2.4|3.6||The p-value is presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in Clinical Global Impression Global Improvement Scale (CGI-I)||3.6|2.4|0.0009
73829423|NCT02858908|147205642|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.132||||0.1857|TWO_SIDED|95.0|-0.33|0.066|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the weekly total number of 3 minute bouts of activity per hour wear time||0.066|-0.330|0.1857
73829424|NCT02858908|147205642|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.325||||0.0054|TWO_SIDED|95.0|-0.549|-0.102|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the weekly total number of 3 minute bouts of activity per hour wear time||-0.102|-0.549|0.0054
73829425|NCT02858908|147205645|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-2.162||||0.0111|TWO_SIDED|95.0|-3.731|-0.593|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete the nine hole peg test for the dominant arm||-0.593|-3.731|0.0111
73829426|NCT02858908|147205645|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.955||||0.2088|TWO_SIDED|95.0|-2.525|0.614|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete the nine hole peg test for the dominant arm||0.614|-2.525|0.2088
73829427|NCT02858908|147205646|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.77||||0.0728|TWO_SIDED|95.0|-3.71|0.18|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the subject top three concerns VAS total score (cm)||0.18|-3.71|0.0728
73829428|NCT02858908|147205646|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.99||||0.0456|TWO_SIDED|95.0|-3.94|-0.04|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the subject top three concerns VAS total score (cm)||-0.04|-3.94|0.0456
73829429|NCT02858908|147205646|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-2.41||||0.0058|TWO_SIDED|95.0|-4.03|-0.8|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the caregiver top three concerns VAS total score (cm)||-0.80|-4.03|0.0058
73829430|NCT02858908|147205646|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.95||||0.0208|TWO_SIDED|95.0|-3.56|-0.34|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the caregiver top three concerns VAS total score (cm)||-0.34|-3.56|0.0208
73829431|NCT02858908|147205647|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.054||||0.0068|TWO_SIDED|95.0|-0.092|-0.017|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the OSU Autism Rating Scale - DSM-IV (OARS-4) total impairment mean||-0.017|-0.092|0.0068
73829432|NCT02858908|147205647|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.009||||0.609|TWO_SIDED|95.0|-0.047|0.028|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the OSU Autism Rating Scale - DSM-IV (OARS-4) total impairment mean||0.028|-0.047|0.6090
73829433|NCT02858908|147205648|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12 in OSU CGI-I. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom. A compound symmetry covariance matrix was used for the repeated visits within subject.|Mean Difference (Net)|3.4||||0.0011|TWO_SIDED|95.0|3.0|3.7||p-values are presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in OSU global improvement scale for autism (OSU CGI-I)||3.7|3.0|0.0011
73829434|NCT02858908|147205648|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12 in OSU CGI-I. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom. A compound symmetry covariance matrix was used for the repeated visits within subject.|Mean Difference (Net)|4.0||||1|TWO_SIDED|95.0|3.6|4.4||p-values are presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in OSU global improvement scale for autism (OSU CGI-I)||4.4|3.6|1.0000
73829435|NCT02858908|147205649|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-5.91|||<|0.0001|TWO_SIDED|95.0|-8.35|-3.47|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline at week 12 in the clinician-completed domain specific causes for concern VAS total score (cm)||-3.47|-8.35|<0.0001
73829436|NCT02858908|147205649|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-3.27||||0.0116|TWO_SIDED|95.0|-5.71|-0.83|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline at week 12 in the clinician-completed domain specific causes for concern VAS total score (cm)||-0.83|-5.71|0.0116
73829437|NCT02858908|147205650|OTHER|An ANCOVA was fitted to the change in the Peabody Picture Vocabulary Test age-based standard score from baseline to end of treatment. The model included the baseline value as a covariate and dose group as a fixed effect.|Mean Difference (Net)|-1.1||||0.6631|TWO_SIDED|95.0|-6.5|4.3|||ANCOVA||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the peabody picture vocabulary test age-based standard score||4.3|-6.5|0.6631
73829438|NCT02858908|147205650|OTHER|An ANCOVA was fitted to the change in the Peabody Picture Vocabulary Test age-based standard score from baseline to end of treatment. The model included the baseline value as a covariate and dose group as a fixed effect.|Mean Difference (Net)|-0.1||||0.9546|TWO_SIDED|95.0|-5.5|5.2|||ANCOVA||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the peabody picture vocabulary test age-based standard score||5.2|-5.5|0.9546
73829439|NCT01773928|147205666|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The probability that the modified process is noninferior to the current one (i.e. lower limit of the 95% CI of the ratio of geometric means \[modified vs. current\] is greater than or equal to 0.67) is above 99% for one strain, and it is around 97% for all three strains (considering the three strains to be independent, 0.99 x 0.99 x 0.99=0.97)|ANCOVA|0.67|||||ONE_SIDED|95.0|0.67||||||||||0.67|
73829440|NCT01773928|147205668|SUPERIORITY_OR_OTHER_LEGACY||ANCOVA|0.67|||||TWO_SIDED|95.0|0.67|1.5||||||"The overall power to prove the similarity between the three lots for all three strains is approximately 99%.~For the two primary co-analyses (Noninferiority and Lot Consistency), the overall power of the immunogenicity analyses is approximately 96% (calculated as 0.97 x 0.99=0.96)."||1.5|0.67|
73829441|NCT01773928|147205669|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Differences between fever incidences (95% CI) between treatment groups VCIV Modified (Total) and TIV was computed for each age cohort separately. The Confidence Interval estimation method was the method of Miettinen \& Nurminen, as described in the StatXact User Manual (i.e. the score statistics, also called Chan's method, page 283).~Noninferiority will be concluded if the upper limit of the 95% CI (VCIV modified-TIV) is \<5%."|Method of Miettinen & Nurminen|1.8||||||95.0|0.1|3.3||||||||3.3|0.1|
73829442|NCT03573297|147205672|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.5745|TWO_SIDED|95.0|0.48|1.43||P-value is based on the log-rank test stratified by modified index episode (manic or depressive) and region (US, non-US).|Log Rank||Hazard ratio (Cariprazine 1.5 or 3.0 mg/day vs. Placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable, stratified by modified index episode (manic or depressive) and region (US, non-US).|||1.43|0.48|0.5745
73829443|NCT03573297|147205672|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.6308|TWO_SIDED|95.0|0.52|1.51||P-value is based on the log-rank test stratified by modified index episode (manic or depressive) and region (US, non-US).|Log Rank||Hazard ratio (Cariprazine 1.5 or 3.0 mg/day vs. Placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable, stratified by modified index episode (manic or depressive) and region (US, non-US).|||1.51|0.52|0.6308
73829444|NCT02273167|147205678|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits (CL) were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CL. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|4.5||||0.055|ONE_SIDED|97.5|-4.0|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate non-inferiority (NI) of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-4.00|0.055
73829445|NCT02273167|147205678|NON_INFERIORITY_OR_EQUIVALENCE|The CLs were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson confidences limits. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|1.59||||0.328|ONE_SIDED|97.5|-6.91|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. A Hochberg procedure was used to control Type I error since there were two alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-6.91|0.328
73829446|NCT02273167|147205679|NON_INFERIORITY_OR_EQUIVALENCE|Confidence limits (CL) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|16.56|||<|0.001|ONE_SIDED|97.5|8.11|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||8.11|<0.001
73829447|NCT02273167|147205679|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits (CLs) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|18.74|||<|0.001|ONE_SIDED|97.5|10.32|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||10.32|<0.001
73829448|NCT02273167|147205680|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|TWO_SIDED|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||12.00|-4.80|0.106
73829449|NCT02273167|147205680|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|TWO_SIDED|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||12.00|-4.80|0.106
73829450|NCT02273167|147205681|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-0.29||||0.569|TWO_SIDED|95.0|-8.74|8.02||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||8.02|-8.74|0.569
73829451|NCT02273167|147205681|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|0.8||||0.455|TWO_SIDED|95.0|-7.65|9.11||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||9.11|-7.65|0.455
73829452|NCT02273167|147205682|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 2-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|7.1||||0.024|TWO_SIDED|95.0|-1.41|15.47|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||15.47|-1.41|0.024
73896545|NCT03456882|147326409|SUPERIORITY|||||||0.3442||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 24 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 24 weeks is not different between groups||||0.3442
73896546|NCT03456882|147326410|SUPERIORITY||difference between mean slopes|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.1503|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 physical mobility. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.1503
73829453|NCT02273167|147205682|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits. Non-inferiority of NER1006 1-Day to MOVIPREP was proven.|Difference in PDR|2.37||||0.268|TWO_SIDED|95.0|-6.12|10.82||Superiority of NER1006 1-Day to MOVIPREP not demonstrated statistically.|Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||10.82|-6.12|0.268
73829454|NCT02273167|147205683|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence intervals.|Difference in PDR|-0.49||||0.579|TWO_SIDED|95.0|-8.85|8.0|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||8.00|-8.85|0.579
73829455|NCT02273167|147205683|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 1-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|0.61||||0.478|TWO_SIDED|95.0|-7.78|9.09|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||9.09|-7.78|0.478
73829456|NCT00315341|147205710|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||shift table analyses|||categorized changes in ALT/AST from BL:(1)BL transaminases(both ALT/AST)≤2X upper limit of normal(ULN)\& remained at this level;(2)BL transaminases ≤2X ULN(either ALT/AST)but increased(either ALT/AST)above this level at any time;(3)BL transaminases \>2X ULN(either ALT/AST)\& decreased and remained at ≤2X ULN(both ALT/AST);(4)BL transaminases(both ALT/AST)\>2X ULN \&remained at this level(both ALT/AST);(5)BL transaminases \>2X ULN(either ALT/AST)\& increased 2X above this level ever(either ALT/AST).||||< 0.05
73829457|NCT05539131|147205733|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.862||||||This is p-valu regarding time and group.|Mixed Models Analysis|||||||0.862
73829458|NCT05539131|147205734|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.662||||||This is p-valu regarding time and group.|Mixed Models Analysis|||||||0.662
73829459|NCT05539131|147205735|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.318||||||This is p-valu regarding time and group.|ANOVA|||||||0.318
73829460|NCT05539131|147205736|SUPERIORITY|||||||0.273|||||||ANOVA|||||||0.273
73829461|NCT05539131|147205737|SUPERIORITY|||||||0.639|||||||ANOVA|||||||0.639
73829462|NCT05539131|147205738|SUPERIORITY|||||||0.452|||||||ANOVA|||||||0.452
73829463|NCT00498550|147205749|SUPERIORITY||difference in treatment means|-4.54|STANDARD_ERROR_OF_MEAN|2.57||0.088|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.088
73829464|NCT00849056|147205761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.56|||ANCOVA|||||-0.56|-0.95|<0.0001
73829465|NCT01898078|147205824|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio|0.97|||||TWO_SIDED|90.0|0.85|1.12|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed Cmax plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric means.||1.12|0.85|
73829466|NCT01898078|147205825|SUPERIORITY_OR_OTHER||Least Square Mean Ratio|1.16|||||TWO_SIDED|90.0|1.01|1.34|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC(last) plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean.||1.34|1.01|
73829467|NCT01898078|147205826|SUPERIORITY_OR_OTHER||Least Square Mean Ratio|1.15|||||TWO_SIDED|90.0|0.96|1.39|||||Estimates for each PK parameter were obtained using a mixed effects model of log(PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC∞ plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean||1.39|0.96|
73829468|NCT01075048|147205830|SUPERIORITY|||||||0.3815|||||||Log Rank|||||||0.3815
73829469|NCT01075048|147205830|SUPERIORITY|||||||0.19|||||||Peto-Peto-Prentice|||||||0.1900
73829470|NCT01075048|147205830|SUPERIORITY|||||||0.1986|||||||Generalized Wilcoxon|||||||0.1986
73829471|NCT01075048|147205830|SUPERIORITY|||||||0.2617|||||||Tarone-Ware|||||||0.2617
73829472|NCT01075048|147205831|SUPERIORITY|||||||0.4488|||||||Log Rank|||||||0.4488
73829473|NCT01075048|147205831|SUPERIORITY|||||||0.2887|||||||Peto-Peto-Prentice|||||||0.2887
73829474|NCT01075048|147205831|SUPERIORITY|||||||0.1851|||||||Generalized Wilcoxon|||||||0.1851
73829475|NCT01075048|147205831|SUPERIORITY|||||||0.2495|||||||Tarone-Ware|||||||0.2495
73829476|NCT01075048|147205833|SUPERIORITY|||||||0.2804|||||||Log Rank|||OS data cutoff as of 12 Oct 2012||||0.2804
73829477|NCT01075048|147205833|SUPERIORITY|||||||0.2469|||||||Log Rank|||OS data cutoff as of 29 Mar 2013||||0.2469
73829478|NCT01075048|147205833|SUPERIORITY|||||||0.1334|||||||Log Rank|||OS data cutoff as of 25 Jul 2013||||0.1334
73829479|NCT01075048|147205833|SUPERIORITY|||||||0.2159|||||||Log Rank|||OS data cutoff as of 20 Feb 2015||||0.2159
73829480|NCT01287936|147205838|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed Rank test|||||||<0.001
73829481|NCT01287936|147205840|SUPERIORITY|||||||0.004|||||||Wilcoxon Signed Rank test|||||||0.004
73829482|NCT01140906|147205847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.53|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.66|-3.4||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-3.40|-7.66|<0.0001
73829483|NCT01140906|147205847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.09|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|-9.21|-4.97||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-4.97|-9.21|<0.0001
73829484|NCT01140906|147205847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.45|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED|95.0|-11.55|-7.35||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-7.35|-11.55|<0.0001
73829485|NCT01140906|147205848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||<|0.0001|TWO_SIDED|95.0|1.76|4.47||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||4.47|1.76|<0.0001
73829486|NCT01140906|147205848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36|||<|0.0001|TWO_SIDED|95.0|2.1|5.36||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||5.36|2.10|<0.0001
73829487|NCT01140906|147205848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|3.61|9.78||This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted Odds Ratio|||||9.78|3.61|<0.0001
73829488|NCT01140906|147205849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.94|-0.44||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.44|-0.94|<0.0001
73829489|NCT01140906|147205849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.70|-1.20|<0.0001
73829490|NCT01140906|147205849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.36|-0.87||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-0.87|-1.36|<0.0001
73829491|NCT01140906|147205850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|1.53||0.0007|TWO_SIDED|95.0|-8.25|-2.22||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-2.22|-8.25|0.0007
73829492|NCT01140906|147205850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|-9.53|-3.31||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-3.31|-9.53|<0.0001
73829493|NCT01140906|147205850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.71|STANDARD_ERROR_OF_MEAN|1.54|<|0.0001|TWO_SIDED|95.0|-11.73|-5.69||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-5.69|-11.73|<0.0001
73829494|NCT01140906|147205851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.32||||0.0016|TWO_SIDED|95.0|1.37|3.91||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||3.91|1.37|0.0016
73829495|NCT01140906|147205851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.65||||0.0002|TWO_SIDED|95.0|1.58|4.44||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||4.44|1.58|0.0002
73829496|NCT01140906|147205851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.01|||<|0.0001|TWO_SIDED|95.0|2.99|8.37||Wald's test. This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted for Odds Ratio|||||8.37|2.99|<0.0001
73829497|NCT01140906|147205852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.24|STANDARD_ERROR_OF_MEAN|1.16||0.0054|TWO_SIDED|95.0|-5.51|-0.97||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.97|-5.51|0.0054
73829498|NCT01140906|147205852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|1.11||0.0005|TWO_SIDED|95.0|-6.11|-1.73||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-1.73|-6.11|0.0005
73829499|NCT01140906|147205852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.93|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-9.16|-4.7||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-4.70|-9.16|<0.0001
73829500|NCT01140906|147205853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.59||0.2524|TWO_SIDED|95.0|-1.83|0.48||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.|||0.48|-1.83|0.2524
73829501|NCT01140906|147205853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.59||0.4186|TWO_SIDED|95.0|-1.64|0.68||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.|||0.68|-1.64|0.4186
73829502|NCT01140906|147205854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.41||0.7372|TWO_SIDED|95.0|-0.95|0.67||A nominal p-value is provided.|ANCOVA|||||0.67|-0.95|0.7372
73829503|NCT01140906|147205854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.41||0.169|TWO_SIDED|95.0|-0.24|1.37||A nominal p-value is provided.|ANCOVA|||||1.37|-0.24|0.1690
73829504|NCT03427411|147205867|NON_INFERIORITY|Non-inferiority was defined as response rates which were sufficiently similar (p\>0.20 by Fisher's exact test).||||||0.6143||||||The p value was calculated and was 0.6143 which is \> 0.2 (pre-defined threshold).|Fisher Exact|||||||0.6143
73829505|NCT02058095|147205893|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
73829506|NCT02058095|147205895|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
73829507|NCT00148798|147205900|SUPERIORITY_OR_OTHER|||||||0.0441|TWO_SIDED|95.0|||||Stratified Log Rank|||Primary efficacy analysis: To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (Stage IIIb vs IV, ECOG 0/1 vs 2) (α=5%).||||0.0441
73829508|NCT00148798|147205901|SUPERIORITY_OR_OTHER|||||||0.3869|TWO_SIDED|95.0|||||Stratified Log Rank|||To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (α=5%).||||0.3869
73829509|NCT00148798|147205902|SUPERIORITY_OR_OTHER|||||||0.0101|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||The best overall response rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).||||0.0101
73829510|NCT00148798|147205903|SUPERIORITY_OR_OTHER|||||||0.6801|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||The disease control rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).||||0.6801
73829511|NCT00977197|147205908|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.008
73829512|NCT00977197|147205909|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.009
73829513|NCT00977197|147205910|SUPERIORITY_OR_OTHER|||||||0.389|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender; rank scale.||||||0.389
73829514|NCT00977197|147205911|SUPERIORITY_OR_OTHER|||||||0.049|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.049
73829515|NCT00977197|147205912|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.044
73829516|NCT00977197|147205913|SUPERIORITY_OR_OTHER|||||||0.35||||||Intent to treat analysis, not adjusted for age and gender.|Chi-squared|||||||0.350
73829517|NCT00977197|147205914|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.020
73829518|NCT00977197|147205915|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.024
73829519|NCT00977197|147205916|SUPERIORITY_OR_OTHER|||||||0.417|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.417
73829520|NCT00977197|147205917|SUPERIORITY_OR_OTHER|||||||0.03||||||Intent to Treat analysis; adjusted for age and gender, rank scale.|ANCOVA|||||||0.030
73829521|NCT00977197|147205918|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.016
73829522|NCT00977197|147205919|SUPERIORITY_OR_OTHER|||||||0.097||||||Intent to Treat analysis; not adjusted for age and gender.|Chi-squared|||||||0.097
73829523|NCT00853385|147205925|SUPERIORITY_OR_OTHER||Percent difference|24.24|||<|0.0001|TWO_SIDED|95.0|13.18|35.31||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||35.31|13.18|<0.0001
73829524|NCT00853385|147205925|SUPERIORITY_OR_OTHER||Percent difference|23.22|||<|0.0001|TWO_SIDED|95.0|12.16|34.29||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||34.29|12.16|<0.0001
73829525|NCT00853385|147205925|SUPERIORITY_OR_OTHER||Percent difference|18.93||||0.0007|TWO_SIDED|95.0|7.9|29.96||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||29.96|7.90|0.0007
73829526|NCT00853385|147205926|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.5|-0.25||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares (LS) mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.25|-0.50|<0.0001
73829527|NCT00853385|147205926|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.19||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.19|-0.43|<0.0001
73829528|NCT00853385|147205926|SUPERIORITY_OR_OTHER||LS mean difference|-0.25|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.13||Statistical testing was done at 5% significance level (2-sided).|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.13|-0.37|<0.0001
73829529|NCT00853385|147205927|SUPERIORITY_OR_OTHER||Percent difference|11.41|||<|0.0001|TWO_SIDED|95.0|6.08|16.73||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||16.73|6.08|<0.0001
73829530|NCT00853385|147205927|SUPERIORITY_OR_OTHER||Percent difference|5.12||||0.0151|TWO_SIDED|95.0|0.98|9.26||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||9.26|0.98|0.0151
73829531|NCT00853385|147205927|SUPERIORITY_OR_OTHER||Percent difference|5.65||||0.0091|TWO_SIDED|95.0|1.4|9.9||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||9.90|1.40|0.0091
73829532|NCT02842866|147205971|NON_INFERIORITY|The 95 percent (%) confidence internal (CI) of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was greater than (\>) -10 percent (%) for all four serogroups.|Difference in percentage|15.7|||||TWO_SIDED|95.0|9.08|22.2||||||Serogroup A||22.2|9.08|
73829533|NCT02842866|147205971|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|27.5|||||TWO_SIDED|95.0|21.2|33.5||||||Serogroup C||33.5|21.2|
73829534|NCT02842866|147205971|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|31.0|||||TWO_SIDED|95.0|24.6|37.0||||||Serogroup Y||37.0|24.6|
73829535|NCT02842866|147205971|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|17.8|||||TWO_SIDED|95.0|11.2|24.2||||||Serogroup W||24.2|11.2|
73829536|NCT02842866|147205972|OTHER||GMT Ratio|1.75|||||TWO_SIDED|95.0|1.4|2.2||||||Serogroup A||2.20|1.40|
73829537|NCT02842866|147205972|OTHER||GMT Ratio|4.1|||||TWO_SIDED|95.0|3.16|5.33||||||Serogroup C||5.33|3.16|
73829538|NCT02842866|147205972|OTHER||GMT Ratio|3.3|||||TWO_SIDED|95.0|2.57|4.23||||||Serogroup Y||4.23|2.57|
73829539|NCT02842866|147205972|OTHER||GMT Ratio|1.81|||||TWO_SIDED|95.0|1.42|2.31||||||Serogroup W||2.31|1.42|
73829540|NCT02081807|147205976|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.57|1.76|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.76|0.57|
73829541|NCT02081807|147205976|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.52|0.94|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Dabigatran vs. Warfarin (as reference group).||0.94|0.52|
73829542|NCT02081807|147205976|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.58|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.98|0.58|
73829543|NCT02081807|147205976|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.53|1.35|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.35|0.53|
73829544|NCT02081807|147205976|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.57|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Rivaroxaban vs. Warfarin (as reference group).||0.98|0.57|
73829545|NCT02081807|147205976|OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.61|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.98|0.61|
73829546|NCT02081807|147205976|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.53|1.51|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.51|0.53|
73829547|NCT02081807|147205976|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.38|0.89|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Apixaban vs. Warfarin (as reference group).||0.89|0.38|
73829548|NCT02081807|147205976|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.5|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.96|0.50|
73829549|NCT02081807|147205977|OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.38|0.69|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.69|0.38|
73829550|NCT02081807|147205977|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.86|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Dabigatran vs. Warfarin (as reference group).||0.86|0.68|
73829551|NCT02081807|147205977|OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.65|0.8|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.80|0.65|
73829552|NCT02081807|147205977|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.88|1.26|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.26|0.88|
73829553|NCT02081807|147205977|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.92|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Rivaroxaban vs. Warfarin (as reference group).||1.12|0.92|
73829554|NCT02081807|147205977|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.94|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.12|0.94|
73829555|NCT02081807|147205977|OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.39|0.66|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.66|0.39|
73829556|NCT02081807|147205977|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.49|0.68|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Apixaban vs. Warfarin (as reference group).||0.68|0.49|
73829557|NCT02081807|147205977|OTHER||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.49|0.64|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.64|0.49|
73829558|NCT02081807|147205978|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.11|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.11|0.69|
73829559|NCT02081807|147205978|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.66|1.02|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.02|0.66|
73829560|NCT02081807|147205978|OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.47|0.88|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.88|0.47|
73829561|NCT02081807|147205979|OTHER||Hazard Ratio (HR)|1.85|||||TWO_SIDED|95.0|1.03|3.3|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||3.30|1.03|
73829562|NCT02081807|147205979|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.65|1.71|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.71|0.65|
73829563|NCT02081807|147205979|OTHER||Hazard Ratio (HR)|0.31|||||TWO_SIDED|95.0|0.1|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.96|0.10|
73829564|NCT02081807|147205980|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.63|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.12|0.63|
73829565|NCT02081807|147205980|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.57|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.96|0.57|
73829566|NCT02081807|147205980|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.45|0.94|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.94|0.45|
73829567|NCT02081807|147205981|OTHER||Hazard Ratio (HR)|0.37|||||TWO_SIDED|95.0|0.18|0.78|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.78|0.18|
73829568|NCT02081807|147205981|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.58|1.72|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.72|0.58|
73829569|NCT02081807|147205981|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.38|1.87|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.87|0.38|
73829570|NCT02081807|147205983|OTHER||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.25|0.59|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.59|0.25|
73829571|NCT02081807|147205983|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.51|0.95|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.95|0.51|
73829572|NCT02081807|147205983|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.43|1.03|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.03|0.43|
73829573|NCT02081807|147205984|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.67|0.84|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.84|0.67|
73829574|NCT02081807|147205984|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.97|1.16|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.16|0.97|
73829575|NCT02081807|147205984|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.47|0.63|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.63|0.47|
73829576|NCT02081807|147205985|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.77|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.04|0.77|
73829577|NCT02081807|147205985|OTHER||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|1.07|1.36|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.36|1.07|
73829578|NCT02081807|147205985|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.48|0.72|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.72|0.48|
73829579|NCT02081807|147205986|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.44|0.8|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.80|0.44|
73829580|NCT02081807|147205986|OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.98|1.57|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.57|0.98|
73829581|NCT02081807|147205986|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.54|1.14|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.14|0.54|
73829582|NCT02081807|147205987|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.08|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.08|0.79|
73829583|NCT02081807|147205987|OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|1.05|1.35|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.35|1.05|
73829584|NCT02081807|147205987|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.67|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.67|0.44|
73829585|NCT02081807|147205989|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.59|78.0|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||078|0.59|
73829586|NCT02081807|147205989|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.93|1.16|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.16|0.93|
73829587|NCT02081807|147205989|OTHER||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.47|0.67|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.67|0.47|
73829588|NCT02081807|147205990|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.34|0.82|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.82|0.34|
73829589|NCT02081807|147205990|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.55|1.29|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.29|0.55|
73829590|NCT02081807|147205990|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.41|1.42|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.42|0.41|
73829591|NCT02081807|147205991|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.6|1.15|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.15|0.60|
73829592|NCT02081807|147205991|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.63|1.14|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.14|0.63|
73829593|NCT02081807|147205991|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.53|1.18|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.18|0.53|
73829594|NCT02081807|147205992|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.5|0.84|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.84|0.50|
73829595|NCT02081807|147205992|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.69|1.01|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Rivaroxaban vs. Warfarin (as reference group).||1.01|0.69|
73829596|NCT02081807|147205992|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.37|0.76|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.76|0.37|
73829597|NCT02081807|147205993|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.47|0.88|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.88|0.47|
73829598|NCT02081807|147205993|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.65|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.04|0.65|
73829599|NCT02081807|147205993|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.39|0.92|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.92|0.39|
73829600|NCT02081807|147205994|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.47|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Dabigatran vs. Warfarin (as reference group).||1.04|0.47|
73829601|NCT02081807|147205994|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.6|1.05|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.05|0.60|
73829602|NCT02081807|147205994|OTHER||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.24|0.73|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.73|0.24|
73829603|NCT00676143|147206003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.979|TWO_SIDED|95.0|-1.18|1.22||Primary variable ADAS-Cog/11 total score had to reach statistical significance, p-values had to reach p \<=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 2.21 point advantage for the bapineuzumab group over placebo on the ADAS-Cog/11 total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."||1.22|-1.18|0.979
73829604|NCT00676143|147206004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.973|TWO_SIDED|95.0|-2.51|2.6||Primary variable DAD total score had to reach statistical significance, p-values had to reach p \<=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in DAD total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 5.39 unit advantage for the bapineuzumab group over placebo on the DAD total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."||2.60|-2.51|0.973
73829605|NCT00676143|147206005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.159|TWO_SIDED|95.0|-0.17|0.03|||Mixed Models Analysis|||"Change in PIB PET SUVr was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 0.152 unit advantage for the bapineuzumab group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."||0.03|-0.17|0.159
73829606|NCT00676143|147206006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.62|TWO_SIDED|95.0|-6.89|4.13|||ANCOVA|||Change in CSF phospho-tau was analyzed using an analysis of covariance (ANCOVA) model. The analysis was based on the treatment difference estimated at Week 71 based on appropriate contrasts or LS means. The number of participants gave 90% power to detect a 13-ng/L advantage in phospho-tau for the bapineuzumab group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05.||4.13|-6.89|0.620
73829607|NCT00676143|147206007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.884|TWO_SIDED|95.0|-1.89|1.63|||Mixed Models Analysis|||"Change in MRI BBSI was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 4.15-cm3 advantage for the bapineuzumab group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."||1.63|-1.89|0.884
73829608|NCT00676143|147206008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.7|TWO_SIDED|95.0|-0.97|1.45|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo||1.45|-0.97|0.700
73829609|NCT00676143|147206009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.949|TWO_SIDED|95.0|-2.61|2.78|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo||2.78|-2.61|0.949
73829610|NCT00676143|147206010|SUPERIORITY_OR_OTHER|||||||0.684|||||||Log Rank|||||||0.684
73829611|NCT00676143|147206011|SUPERIORITY_OR_OTHER|||||||0.383|||||||Log Rank|||||||0.383
73829612|NCT00676143|147206012|SUPERIORITY_OR_OTHER|||||||0.191|||||||Log Rank|||||||0.191
73829613|NCT00676143|147206013|SUPERIORITY_OR_OTHER|||||||0.478|||||||Log Rank|||||||0.478
73829614|NCT00676143|147206014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.462|TWO_SIDED|95.0|-0.41|0.13|||Mixed Models Analysis|||Change in DS total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.||0.13|-0.41|0.462
73829615|NCT00676143|147206016|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.086
73829616|NCT00676143|147206018|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.120
73829617|NCT00676143|147206019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.448|TWO_SIDED|95.0|-0.55|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.||0.24|-0.55|0.448
73829618|NCT00701363|147206034|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED||||||ANCOVA|||One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.||||0.0013
73829619|NCT00701363|147206034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73829620|NCT00701363|147206034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73829621|NCT00701363|147206035|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||t-test, 2 sided|||||||0.0009
73829622|NCT00701363|147206035|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73829623|NCT00701363|147206035|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73829624|NCT00701363|147206035|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||t-test, 2 sided|||||||0.0170
73829625|NCT00701363|147206036|SUPERIORITY_OR_OTHER|||||||0.0103|TWO_SIDED||||||t-test, 2 sided|||Difference in baseline IGF-1 levels between 108 subjects with normalized IGF-1 levels at week 24 (A+B+C) and 14 subjects with uncontrolled IGF-1 levels at week 24.||||0.0103
73829626|NCT02592824|147206106|SUPERIORITY|||||||0.086|||||||t-test, 2 sided|||Two-sided Student's t-test used for sample size estimation which was based on data from the first GLUTAMICS trial.||||0.086
73829627|NCT02592824|147206107|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
73829628|NCT02592824|147206108|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
73829629|NCT02592824|147206113|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
73829630|NCT05233761|147206128|SUPERIORITY|The mean nightly difference in SWS + REM sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority.|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.6||0.035|TWO_SIDED|95.0|0.1|2.5|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS + REM (% TST) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.5|0.1|0.0350
73829631|NCT05233761|147206129|SUPERIORITY|The mean nightly difference in SWS Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0019|TWO_SIDED|95.0|0.4|1.6|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||1.6|0.4|0.0019
73829632|NCT05233761|147206129|SUPERIORITY|The mean nightly difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.52|TWO_SIDED|95.0|-0.6|1.2|||t-test, 2 sided|||The null hypothesis was that there was no difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||1.2|-.6|0.52
73829633|NCT05233761|147206129|SUPERIORITY|The mean nightly difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.004|TWO_SIDED|95.0|-2.8|-0.5|||t-test, 2 sided|||The null hypothesis was that there was no difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||-0.5|-2.8|0.0040
73829634|NCT05233761|147206129|SUPERIORITY|The mean nightly difference in Awake Time (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.6||0.24|TWO_SIDED|95.0|-0.5|2.0|||t-test, 2 sided|||The null hypothesis was that there was no difference in Awake Time (% TST) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.0|-.5|0.24
73829635|NCT05233761|147206130|SUPERIORITY|The mean nightly difference in SWS + REM Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|2.6||0.0117|TWO_SIDED|95.0|1.7|13.3|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS + REM Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||13.3|1.7|0.0117
73829636|NCT05233761|147206130|SUPERIORITY|The mean nightly difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|1.3||0.0126|TWO_SIDED|95.0|0.7|5.9|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||5.9|0.7|0.0126
73896547|NCT03456882|147326410|SUPERIORITY||difference between mean slopes|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.1556|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 ADL and independence.Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.1556
73829637|NCT05233761|147206130|SUPERIORITY|The mean nightly difference in REM sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.0||0.51|TWO_SIDED|95.0|-2.7|5.3|||t-test, 2 sided|||The null hypothesis was that there was no difference in REM Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||5.3|-2.7|0.51
73829638|NCT05233761|147206130|SUPERIORITY|The mean nightly difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.6||0.0574|TWO_SIDED|95.0|-13.7|0.2|||t-test, 2 sided|||The null hypothesis was that there was no difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||0.2|-13.7|0.0574
73829639|NCT05233761|147206130|SUPERIORITY|The mean nightly difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|2.4||0.3|TWO_SIDED|95.0|-2.4|6.9|||t-test, 2 sided|||The null hypothesis was that there was no difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||6.9|-2.4|0.3
73829640|NCT05233761|147206130|SUPERIORITY|The mean nightly difference in Total Sleep Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|4.7||0.14|TWO_SIDED|95.0|-16.1|2.4|||t-test, 2 sided|||The null hypothesis was that there was no difference in Total Sleep Time (min) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.4|-16.1|0.14
73829641|NCT05233761|147206131|SUPERIORITY|"The mean nightly difference in the perception of better sleep in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.5||0.53|TWO_SIDED|95.0|-0.7|1.3|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of better sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.3|-.7|0.53
73829642|NCT05233761|147206131|SUPERIORITY|"The mean nightly difference in the perception of sleep induction in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.6||0.32|TWO_SIDED|95.0|-0.6|1.7|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep induction in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.7|-0.6|0.32
73829643|NCT05233761|147206131|SUPERIORITY|"The mean nightly difference in the perception of sleep duration in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2|TWO_SIDED|95.0|-0.4|1.9|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep duration in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.9|-0.4|0.20
73829644|NCT05233761|147206131|SUPERIORITY|"The mean nightly difference in the perception of sleep depth in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.6||0.45|TWO_SIDED|95.0|-0.7|1.6|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep depth in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.6|-0.7|0.45
73829645|NCT05233761|147206131|SUPERIORITY|"The mean nightly difference in the perception of vivid dreams in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.4|TWO_SIDED|95.0|-0.8|1.9|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of vivid dreams in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.9|-0.8|0.4
73829646|NCT01654276|147206184|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
73829647|NCT01991795|147206192|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.0378|TWO_SIDED|95.0|0.81|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.99|0.81|0.0378
73829648|NCT01991795|147206193|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.7883|TWO_SIDED|95.0|0.88|1.18||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.18|0.88|0.7883
73829649|NCT01991795|147206194|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0294|TWO_SIDED|95.0|0.71|0.98||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.98|0.71|0.0294
73829650|NCT01991795|147206195|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0375|TWO_SIDED|95.0|0.64|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.99|0.64|0.0375
73829651|NCT01991795|147206196|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.6846|TWO_SIDED|95.0|0.87|1.1|||Regression, Cox|||||1.10|0.87|0.6846
73829652|NCT01991795|147206197|SUPERIORITY||Hazard Ratio (HR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.82|2.94|||Regression, Cox|||||2.94|1.82|<0.0001
73829653|NCT01991795|147206198|SUPERIORITY||Hazard Ratio (HR)|2.49|||<|0.0001|TWO_SIDED|95.0|2.02|3.07|||Regression, Cox|||||3.07|2.02|<0.0001
73829654|NCT01991795|147206199|SUPERIORITY||Hazard Ratio (HR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.98|2.93|||Regression, Cox|||||2.93|1.98|<0.0001
73829655|NCT01991795|147206200|SUPERIORITY||Hazard Ratio (HR)|4.04|||<|0.0001|TWO_SIDED|95.0|3.32|4.92|||Regression, Cox|||||4.92|3.32|<0.0001
73829656|NCT06119854|147206212|OTHER||Risk Ratio (RR)|1.207|||||TWO_SIDED|95.0|0.406|3.59|||||The CBT arm is the numerator and the standard arm is the denominator.|||3.590|0.406|
73829657|NCT06119854|147206212|OTHER||Risk Difference (RD)|0.003|||||TWO_SIDED|95.0|-0.013|0.018|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.018|-0.013|
73829658|NCT06119854|147206212|OTHER||Risk Ratio (RR)|0.687|||||TWO_SIDED|95.0|0.194|2.436|||||The inoculation arm is the numerator and the standard arm is the denominator.|||2.436|0.194|
73829659|NCT06119854|147206212|OTHER||Risk Difference (RD)|-0.004|||||TWO_SIDED|95.0|-0.018|0.01|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.010|-0.018|
73829660|NCT06119854|147206213|OTHER||Risk Ratio (RR)|0.992|||||TWO_SIDED|95.0|0.785|1.253|||||The CBT arm is the numerator and the standard arm is the denominator.|||1.253|0.785|
73829661|NCT06119854|147206213|OTHER||Risk Difference (RD)|-0.003|||||TWO_SIDED|95.0|-0.063|0.058|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.058|-0.063|
73829662|NCT06119854|147206213|OTHER||Risk Ratio (RR)|1.227|||||TWO_SIDED|95.0|0.981|1.534|||||The inoculation arm is the numerator and the standard arm is the denominator.|||1.534|0.981|
73829663|NCT06119854|147206213|OTHER||Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|0.008|0.133|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.133|0.008|
73829664|NCT06119854|147206214|OTHER||Risk Ratio (RR)|1.063|||||TWO_SIDED|95.0|0.74|1.527|||||CBT group represents the numerator and standard (conventional) represents the denominator|||1.527|0.740|
73829665|NCT06119854|147206214|OTHER||Risk Difference (RD)|0.008|||||TWO_SIDED|95.0|-0.037|0.053|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm|||0.053|-0.037|
73829666|NCT06119854|147206214|OTHER||Risk Ratio (RR)|1.262|||||TWO_SIDED|95.0|0.892|1.784|||||The inoculation arm is the numerator and the standard arm is the denominator.|||1.784|0.892|
73829667|NCT06119854|147206214|OTHER||Risk Difference (RD)|0.034|||||TWO_SIDED|95.0|-0.013|0.08|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.080|-0.013|
73829668|NCT06119854|147206215|OTHER||Risk Ratio (RR)|1.131|||||TWO_SIDED|95.0|0.911|1.406|||||CBT arm is the numerator and the standard arm is the denominator.|||1.406|0.911|
73829669|NCT06119854|147206215|OTHER||Risk Difference (RD)|0.045|||||TWO_SIDED|95.0|-0.019|0.109|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.109|-0.019|
73829670|NCT06119854|147206215|OTHER||Risk Ratio (RR)|1.323|||||TWO_SIDED|95.0|1.074|1.631|||||the inoculation arm is the numerator and the standard arm is the denominator.|||1.631|1.074|
73829671|NCT06119854|147206215|OTHER||Risk Difference (RD)|0.111|||||TWO_SIDED|95.0|0.045|0.176|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.176|0.045|
73829672|NCT03104374|147206243|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|32.8|||<|0.0001|TWO_SIDED|95.0|24.0|41.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||41.6|24.0|<0.0001
73829673|NCT03104374|147206243|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|39.7|||<|0.0001|TWO_SIDED|95.0|31.1|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||48.3|31.1|<0.0001
73829674|NCT03104374|147206244|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Least Squares (LS) Mean Difference|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.3|-0.12|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.12|-0.30|<0.0001
73829675|NCT03104374|147206244|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.22|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.22|-0.40|<0.0001
73829676|NCT03104374|147206245|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|27.6|||<|0.0001|TWO_SIDED|95.0|19.2|36.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||36.1|19.2|<0.0001
73829677|NCT03104374|147206245|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|31.0|||<|0.0001|TWO_SIDED|95.0|22.3|39.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||39.8|22.3|<0.0001
73829678|NCT03104374|147206246|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|36.3|||<|0.0001|TWO_SIDED|95.0|25.6|46.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||46.9|25.6|<0.0001
73829679|NCT03104374|147206246|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|40.5|||<|0.0001|TWO_SIDED|95.0|29.9|51.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||51.0|29.9|<0.0001
73829680|NCT03104374|147206247|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.52|||<|0.0001|TWO_SIDED|95.0|2.07|4.98|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||4.98|2.07|<0.0001
73829681|NCT03104374|147206247|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|5.44|||<|0.0001|TWO_SIDED|95.0|3.99|6.88|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.88|3.99|<0.0001
73829682|NCT03104374|147206248|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.7|||<|0.0001|TWO_SIDED|95.0|2.0|5.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.4|2.0|<0.0001
73829683|NCT03104374|147206248|SUPERIORITY||LS Mean Difference|4.8|||<|0.0001|TWO_SIDED|95.0|3.1|6.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.||6.4|3.1|<0.0001
73829684|NCT03104374|147206249|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|22.3|||<|0.0001|TWO_SIDED|95.0|16.0|28.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||28.6|16.0|<0.0001
73829685|NCT03104374|147206249|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|26.1|||<|0.0001|TWO_SIDED|95.0|19.7|32.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||32.5|19.7|<0.0001
73829686|NCT03104374|147206250|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-22.9|||<|0.0001|TWO_SIDED|95.0|-27.4|-18.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-18.4|-27.4|<0.0001
73829687|NCT03104374|147206250|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|95.0|-32.7|-23.8|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.8|-32.7|<0.0001
73829688|NCT03104374|147206251|SUPERIORITY||Response Rate Difference|27.0|||<|0.0001|TWO_SIDED|95.0|20.1|33.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||33.9|20.1|<0.0001
73829689|NCT03104374|147206251|SUPERIORITY||Response Rate Difference|32.9|||<|0.0001|TWO_SIDED|95.0|25.9|39.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||39.9|25.9|<0.0001
73829690|NCT03104374|147206252|SUPERIORITY||Response Rate Difference|8.1|||<|0.0001|TWO_SIDED|95.0|4.2|11.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||11.9|4.2|<0.0001
73829691|NCT03104374|147206252|SUPERIORITY||Response Rate Difference|16.0|||<|0.0001|TWO_SIDED|95.0|11.0|21.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||21.1|11.0|<0.0001
73829692|NCT03104374|147206253|SUPERIORITY||Response Rate Difference|21.9|||<|0.0001|TWO_SIDED|95.0|14.3|29.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.4|14.3|<0.0001
73829693|NCT03104374|147206253|SUPERIORITY||Response Rate Difference|22.6|||<|0.0001|TWO_SIDED|95.0|15.1|30.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||30.2|15.1|<0.0001
73829694|NCT04609514|147206259|SUPERIORITY||Median Difference (Final Values)|10.95||||0.51|TWO_SIDED||||||Wilcoxon Rank Sum Test|||||||0.51
73829695|NCT04609514|147206260|SUPERIORITY||||||<|0.001|||||||Wilcoxon Rank Sum Test|||||||<0.001
73829696|NCT04609514|147206265|SUPERIORITY|||||||0.39||||||A robust Yuen's test was conducted with an apriori threshold of 0.05 for statistical significance. No covariates were introduced in the model.|Robust Yuen's test|||||||0.39
73829697|NCT04609514|147206266|SUPERIORITY|||||||0.4|||||||Robust Yuen's test|||||||0.40
73829698|NCT04609514|147206267|SUPERIORITY|||||||0.478|||||||Wilcoxon rank sum test|Wilcoxon rank sum test with continuity correction.||||||0.478
73829699|NCT04609514|147206268|SUPERIORITY|||||||0.51|||||||Wilcoxon rank sum test|Wilcoxon rank sum test with continuity correction.||||||0.51
73829700|NCT04609514|147206270|SUPERIORITY||Odds Ratio (OR)|1.185||||0.8392|TWO_SIDED|95.0|0.23|6.119|||Regression, Logistic|||||6.119|0.23|0.8392
73829701|NCT04609514|147206271|SUPERIORITY|||||||1|||||||Pearson's Chi-squared test|Pearson's Chi-squared test with Yates' continuity correction.||||||1.00
73829702|NCT00909870|147206273|SUPERIORITY_OR_OTHER||Difference in proportions|6.5||||0.103|TWO_SIDED|95.0||||This p-value did not meet the prespecified threshold for statistical significance of \< 0.05|Chi-squared|Unadjusted||"H0: the proportion of responders in the Dermagraft group = the proportion of responders in the Control group.~HA: the proportion of responders in the Dermagraft group ≠ the proportion of responders in the Control group.~The proportion of responders in the Dermagraft group was compared with the proportion of responders in the control group using the uncorrected chi-square test for 2x2 contingency tables. The difference between the groups was expected to be 13%."||||0.1030
73829703|NCT00909870|147206274|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.0||||0.4046||95.0||||This p-value did not meet the prespecified threshold for statistical significance of \< 0.05|Log Rank|||||||0.4046
73829704|NCT00909870|147206275|SUPERIORITY_OR_OTHER||Difference in proportions|10.0||||0.0239||95.0||||Unadjusted|Chi-squared|Unadjusted||Pre-specified subgroup analysis of the primary endpoint||||0.0239
73829705|NCT01232283|147206280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|23.0|||<|0.0001|TWO_SIDED|95.0|16.3|29.6|||Chi-squared|||||29.6|16.3|<0.0001
73829706|NCT01232283|147206281|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1|||<|0.0001|TWO_SIDED|95.0|10.2|21.9|||Chi-squared|||||21.9|10.2|<0.0001
73829707|NCT01232283|147206282|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-42.15|||<|0.0001|TWO_SIDED|95.0|-51.11|-33.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-33.20|-51.11|<0.0001
73829708|NCT01232283|147206283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.8|||<|0.0001|TWO_SIDED|95.0|-42.4|-27.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-27.2|-42.4|<0.0001
73829709|NCT01232283|147206284|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.8|||<|0.0001|TWO_SIDED|95.0|26.9|44.7|||Chi-squared|||||44.7|26.9|< 0.0001
73829710|NCT01232283|147206285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.3|||<|0.0001|TWO_SIDED|95.0|-28.4|-14.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-14.2|-28.4|<0.0001
73829711|NCT01232283|147206286|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.8|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-2.8|-5.3|<0.0001
73829712|NCT01232283|147206287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.63||||0.0078|TWO_SIDED|95.0|0.69|4.56|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||4.56|0.69|0.0078
73829713|NCT01232283|147206288|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.2|||<|0.0001|TWO_SIDED|95.0|8.5|20.0|||Chi-squared|||||20.0|8.5|<0.0001
73829714|NCT01232283|147206289|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|7.7|||<|0.0001|TWO_SIDED|95.0|3.408|17.399|||Log Rank|||||17.399|3.408|<0.0001
73829715|NCT04773028|147206294|OTHER||Mean Difference (Final Values)|-93054.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
73829716|NCT02966834|147206310|OTHER||Mean Difference (Net)|-0.47|||||TWO_SIDED|95.0|-1.75|0.82||||||||0.82|-1.75|
73829717|NCT02966834|147206310|OTHER||Mean Difference (Net)|-0.88|||||TWO_SIDED|95.0|-2.07|0.31||||||||0.31|-2.07|
73829718|NCT02966834|147206310|OTHER||Mean Difference (Net)|-0.88|||||TWO_SIDED|95.0|-2.03|0.28||||||||0.28|-2.03|
73829719|NCT02966834|147206310|OTHER||Mean Difference (Net)|-1.13|||||TWO_SIDED|95.0|-2.29|0.03||||||||0.03|-2.29|
73829720|NCT02966834|147206310|OTHER||Mean Difference (Net)|-0.53|||||TWO_SIDED|95.0|-1.71|0.65||||||||0.65|-1.71|
73829721|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.9|2.3|||||Symptoms|||2.3|-1.9|
73829722|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.5|2.5|||||Symptoms|||2.5|-1.5|
73829723|NCT02966834|147206311|OTHER||Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-3.1|0.8|||||Symptoms|||0.8|-3.1|
73829724|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-1.8|2.0|||||Symptoms|||2.0|-1.8|
73829725|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.0|1.9|||||Symptoms|||1.9|-2.0|
73829726|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.3|2.2|||||Itch|||2.2|-1.3|
73829727|NCT02966834|147206311|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.8|1.3|||||Itch|||1.3|-1.8|
73829728|NCT02966834|147206311|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.9|1.2|||||Itch|||1.2|-1.9|
73829729|NCT02966834|147206311|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-2.6|0.5|||||Itch|||0.5|-2.6|
73829730|NCT02966834|147206311|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.9|1.3|||||Itch|||1.3|-1.9|
73829731|NCT02966834|147206311|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-4.5|3.2|||||Fatigue|||3.2|-4.5|
73829732|NCT02966834|147206311|OTHER||Median Difference (Net)|0.7|||||TWO_SIDED|95.0|-2.8|4.2|||||Fatigue|||4.2|-2.8|
73829733|NCT02966834|147206311|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|0.0|7.0|||||Fatigue|||7.0|0.0|
73829734|NCT02966834|147206311|OTHER||Mean Difference (Net)|1.7|||||TWO_SIDED|95.0|-1.8|5.1|||||Fatigue|||5.1|-1.8|
73829735|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-3.6|3.6|||||Fatigue|||3.6|-3.6|
73829736|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.5|2.6|||||Cognitive|||2.6|-2.5|
73829737|NCT02966834|147206311|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.9|1.7|||||Cognitive|||1.7|-2.9|
73829738|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.1|2.5|||||Cognitive|||2.5|-2.1|
73829739|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.8|2.8|||||Cognitive|||2.8|-1.8|
73829740|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.2|2.5|||||Cognitive|||2.5|-2.2|
73829741|NCT02966834|147206311|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-2.1|0.4|||||Emotional|||0.4|-2.1|
73829742|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.9|1.3|||||Emotional|||1.3|-0.9|
73829743|NCT02966834|147206311|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.2|1.1|||||Emotional|||1.1|-1.2|
73829744|NCT02966834|147206311|OTHER||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-1.9|0.3|||||Emotional|||0.3|-1.9|
73829745|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-1.2|1.1|||||Emotional|||1.1|-1.2|
73829746|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-2.4|3.0|||||Social|||3.0|-2.4|
73829747|NCT02966834|147206311|OTHER||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-1.3|3.7|||||Social|||3.7|-1.3|
73829748|NCT02966834|147206311|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.3|2.7|||||Social|||2.7|-2.3|
73829749|NCT02966834|147206311|OTHER||Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-4.8|0.1|||||Social|||0.1|-4.8|
73829750|NCT02966834|147206311|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-2.8|2.4|||||Social|||2.4|-2.8|
73829751|NCT02966834|147206312|OTHER||Mean Difference (Net)|-106.8|||||TWO_SIDED|95.0|-251.7|38.2||||||||38.2|-251.7|
73829752|NCT02966834|147206312|OTHER||Mean Difference (Net)|-87.4|||||TWO_SIDED|95.0|-198.5|23.8||||||||23.8|-198.5|
73829753|NCT02966834|147206312|OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-125.6|126.5||||||||126.5|-125.6|
73829754|NCT02966834|147206312|OTHER||Mean Difference (Net)|-78.3|||||TWO_SIDED|95.0|-211.5|54.8||||||||54.8|-211.5|
73829755|NCT02966834|147206312|OTHER||Mean Difference (Net)|-30.0|||||TWO_SIDED|95.0|-170.7|110.7||||||||110.7|-170.7|
73829756|NCT02966834|147206314|OTHER||Mean Difference (Net)|-21.4|||||TWO_SIDED|95.0|-58.4|15.5||||||||15.5|-58.4|
73829757|NCT02966834|147206314|OTHER||Mean Difference (Net)|-12.7|||||TWO_SIDED|95.0|-41.9|16.4||||||||16.4|-41.9|
73829758|NCT02966834|147206314|OTHER||Mean Difference (Net)|-15.0|||||TWO_SIDED|95.0|-49.9|20.0||||||||20.0|-49.9|
73829759|NCT02966834|147206314|OTHER||Mean Difference (Net)|-26.5|||||TWO_SIDED|95.0|-63.3|10.4||||||||10.4|-63.3|
73829760|NCT02966834|147206314|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-36.7|37.1||||||||37.1|-36.7|
73829761|NCT02966834|147206315|OTHER||Mean Difference (Net)|-20.0|||||TWO_SIDED|95.0|-52.73|12.74||||||||12.74|-52.73|
73829762|NCT02966834|147206315|OTHER||Mean Difference (Net)|-24.7|||||TWO_SIDED|95.0|-50.8|1.39||||||||1.39|-50.80|
73829763|NCT02966834|147206315|OTHER||Mean Difference (Net)|-22.61|||||TWO_SIDED|95.0|-53.39|8.16||||||||8.16|-53.39|
73829764|NCT02966834|147206315|OTHER||Mean Difference (Net)|-31.67|||||TWO_SIDED|95.0|-63.44|0.09||||||||0.09|-63.44|
73829765|NCT02966834|147206315|OTHER||Mean Difference (Net)|-5.79|||||TWO_SIDED|95.0|-38.33|26.74||||||||26.74|-38.33|
73829766|NCT02966834|147206316|OTHER||Mean Difference (Net)|-106.0|||||TWO_SIDED|95.0|-205.1|-6.8||||||||-6.8|-205.1|
73829767|NCT02966834|147206316|OTHER||Mean Difference (Net)|-65.5|||||TWO_SIDED|95.0|-148.5|17.6||||||||17.6|-148.5|
73829768|NCT02966834|147206316|OTHER||Mean Difference (Net)|-42.8|||||TWO_SIDED|95.0|-136.5|50.9||||||||50.9|-136.5|
73829769|NCT02966834|147206316|OTHER||Mean Difference (Net)|-65.8|||||TWO_SIDED|95.0|-161.2|29.5||||||||29.5|-161.2|
73829770|NCT02966834|147206316|OTHER||Mean Difference (Net)|-54.1|||||TWO_SIDED|95.0|-153.6|45.3||||||||45.3|-153.6|
73829771|NCT02966834|147206317|OTHER||Mean Difference (Net)|-6.099|||||TWO_SIDED|95.0|-11.929|-0.268||||||||-0.268|-11.929|
73829772|NCT02966834|147206317|OTHER||Mean Difference (Net)|-2.337|||||TWO_SIDED|95.0|-6.962|2.289||||||||2.289|-6.962|
73829773|NCT02966834|147206317|OTHER||Mean Difference (Net)|-2.232|||||TWO_SIDED|95.0|-7.679|3.215||||||||3.215|-7.679|
73829774|NCT02966834|147206317|OTHER||Mean Difference (Net)|-1.492|||||TWO_SIDED|95.0|-7.413|4.43||||||||4.430|-7.413|
73829775|NCT02966834|147206317|OTHER||Mean Difference (Net)|5.236|||||TWO_SIDED|95.0|-0.591|11.063||||||||11.063|-0.591|
73829776|NCT02966834|147206318|OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-2.7|1.6||||||||1.6|-2.7|
73829777|NCT02966834|147206318|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-1.5|2.1||||||||2.1|-1.5|
73829778|NCT02966834|147206318|OTHER||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-1.2|2.7||||||||2.7|-1.2|
73829779|NCT02966834|147206318|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.1|2.0||||||||2.0|-2.1|
73829780|NCT02966834|147206318|OTHER||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-1.5|2.9||||||||2.9|-1.5|
73829781|NCT02966834|147206319|OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.08|0.04||||||||0.04|-0.08|
73829782|NCT02966834|147206319|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.09|0.01||||||||0.01|-0.09|
73829783|NCT02966834|147206319|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.06|0.05||||||||0.05|-0.06|
73829784|NCT02966834|147206319|OTHER||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.09|0.02||||||||0.02|-0.09|
73829785|NCT02966834|147206319|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.1|0.02||||||||0.02|-0.10|
73829786|NCT02966834|147206320|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.33|0.63||||||||0.63|-0.33|
73829787|NCT02966834|147206320|OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.51|0.3||||||||0.30|-0.51|
73829788|NCT02966834|147206320|OTHER||Mean Difference (Net)|0.12|||||TWO_SIDED|95.0|-0.34|0.58||||||||0.58|-0.34|
73829789|NCT02966834|147206320|OTHER||Mean Difference (Net)|-0.08|||||TWO_SIDED|95.0|-0.54|0.38||||||||0.38|-0.54|
73829790|NCT02966834|147206320|OTHER||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.54|0.41||||||||0.41|-0.54|
73829791|NCT02966834|147206330|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|0.69|12.02|||||Analysis was performed using Logistic regression. No covariates were used.|||12.02|0.69|
73829792|NCT02966834|147206330|OTHER||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.48|5.02|||||Analysis was performed using Logistic regression. No covariates were used.|||5.02|0.48|
73829793|NCT02966834|147206330|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.84|10.76|||||Analysis was performed using Logistic regression. No covariates were used.|||10.76|0.84|
73829794|NCT02966834|147206330|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.84|10.76|||||Analysis was performed using Logistic regression. No covariates were used.|||10.76|0.84|
73829795|NCT02966834|147206330|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.43|4.13|||||Analysis was performed using Logistic regression. No covariates were used.|||4.13|0.43|
73829796|NCT02966834|147206331|OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.41|4.47|||||Analysis was performed using Logistic regression. No covariates were used.|||4.47|0.41|
73829797|NCT02966834|147206331|OTHER||Odds Ratio (OR)|3.18|||||TWO_SIDED|95.0|0.95|10.65|||||Analysis was performed using Logistic regression. No covariates were used.|||10.65|0.95|
73829798|NCT02966834|147206331|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.62|5.53|||||Analysis was performed using Logistic regression. No covariates were used.|||5.53|0.62|
73829799|NCT02966834|147206331|OTHER||Odds Ratio (OR)|2.27|||||TWO_SIDED|95.0|0.74|6.92|||||Analysis was performed using Logistic regression. No covariates were used.|||6.92|0.74|
73829800|NCT02966834|147206331|OTHER||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|0.69|6.51|||||Analysis was performed using Logistic regression. No covariates were used.|||6.51|0.69|
73829801|NCT02966834|147206332|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.27|3.04|||||Analysis was performed using Logistic regression. No covariates were used.|||3.04|0.27|
73829802|NCT02966834|147206332|OTHER||Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|0.73|6.91|||||Analysis was performed using Logistic regression. No covariates were used.|||6.91|0.73|
73829803|NCT02966834|147206332|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.35|3.08|||||Analysis was performed using Logistic regression. No covariates were used.|||3.08|0.35|
73829804|NCT02966834|147206332|OTHER||Odds Ratio (OR)|2.17|||||TWO_SIDED|95.0|0.73|6.42|||||Analysis was performed using Logistic regression. No covariates were used.|||6.42|0.73|
73829805|NCT02966834|147206332|OTHER||Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.67|5.99|||||Analysis was performed using Logistic regression. No covariates were used.|||5.99|0.67|
73829806|NCT02966834|147206333|OTHER||Mean Difference (Net)|18.21|||||TWO_SIDED|95.0|-2.59|39.0||||||||39.00|-2.59|
73829807|NCT02966834|147206333|OTHER||Mean Difference (Net)|11.05|||||TWO_SIDED|95.0|-7.42|29.53||||||||29.53|-7.42|
73829808|NCT02966834|147206333|OTHER||Mean Difference (Net)|18.44|||||TWO_SIDED|95.0|0.82|36.06||||||||36.06|0.82|
73829809|NCT02966834|147206333|OTHER||Mean Difference (Net)|25.48|||||TWO_SIDED|95.0|7.0|43.95||||||||43.95|7.00|
73829810|NCT02966834|147206333|OTHER||Mean Difference (Net)|13.26|||||TWO_SIDED|95.0|-5.47|31.99||||||||31.99|-5.47|
73829811|NCT02966834|147206334|OTHER||Mean Difference (Net)|14.99|||||TWO_SIDED|95.0|-5.13|35.1||||||||35.10|-5.13|
73829812|NCT02966834|147206334|OTHER||Mean Difference (Net)|6.97|||||TWO_SIDED|95.0|-10.9|24.84||||||||24.84|-10.90|
73829813|NCT02966834|147206334|OTHER||Mean Difference (Net)|11.78|||||TWO_SIDED|95.0|-5.27|28.82||||||||28.82|-5.27|
73829814|NCT02966834|147206334|OTHER||Mean Difference (Net)|21.83|||||TWO_SIDED|95.0|3.96|39.7||||||||39.70|3.96|
73829815|NCT02966834|147206334|OTHER||Mean Difference (Net)|21.58|||||TWO_SIDED|95.0|3.46|39.69||||||||39.69|3.46|
73829816|NCT02966834|147206335|OTHER||Mean Difference (Net)|6.15|||||TWO_SIDED|95.0|-14.76|27.06||||||||27.06|-14.76|
73829817|NCT02966834|147206335|OTHER||Mean Difference (Net)|7.26|||||TWO_SIDED|95.0|-11.32|25.84||||||||25.84|-11.32|
73829818|NCT02966834|147206335|OTHER||Mean Difference (Net)|9.13|||||TWO_SIDED|95.0|-8.59|26.85||||||||26.85|-8.59|
73829819|NCT02966834|147206335|OTHER||Mean Difference (Net)|19.94|||||TWO_SIDED|95.0|1.36|38.51||||||||38.51|1.36|
73829820|NCT02966834|147206335|OTHER||Mean Difference (Net)|27.04|||||TWO_SIDED|95.0|8.2|45.87||||||||45.87|8.20|
73829821|NCT02966834|147206336|OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-1.46|0.92||||||||0.92|-1.46|
73829822|NCT02966834|147206336|OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-1.58|0.62||||||||0.62|-1.58|
73829823|NCT02966834|147206336|OTHER||Mean Difference (Net)|-0.46|||||TWO_SIDED|95.0|-1.53|0.61||||||||0.61|-1.53|
73829824|NCT02966834|147206336|OTHER||Mean Difference (Net)|-0.96|||||TWO_SIDED|95.0|-2.03|0.12||||||||0.12|-2.03|
73829825|NCT02966834|147206336|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.4|0.8||||||||0.80|-1.40|
73829826|NCT02966834|147206337|OTHER||Mean Difference (Net)|-0.39|||||TWO_SIDED|95.0|-1.49|0.71||||||||0.71|-1.49|
73829827|NCT02966834|147206337|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.41|0.61||||||||0.61|-1.41|
73829828|NCT02966834|147206337|OTHER||Mean Difference (Net)|-0.26|||||TWO_SIDED|95.0|-1.24|0.72||||||||0.72|-1.24|
73829829|NCT02966834|147206337|OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-1.39|0.56||||||||0.56|-1.39|
73829830|NCT02966834|147206337|OTHER||Mean Difference (Net)|-0.29|||||TWO_SIDED|95.0|-1.28|0.7||||||||0.70|-1.28|
73829831|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.7|0.5|||||Duration|||0.5|-0.7|
73829832|NCT02966834|147206338|OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.2|0.9|||||Duration|||0.9|-0.2|
73829833|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.0|0.1|||||Duration|||0.1|-1.0|
73829834|NCT02966834|147206338|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||||Duration|||0.7|-0.3|
73829835|NCT02966834|147206338|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.4|0.6|||||Duration|||0.6|-0.4|
73829836|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.3|||||Degree|||0.3|-0.8|
73829837|NCT02966834|147206338|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Degree|||0.5|-0.5|
73829838|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.6|0.5|||||Degree|||0.5|-0.6|
73829839|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.7|0.3|||||Degree|||0.3|-0.7|
73829840|NCT02966834|147206338|OTHER||Median Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.6|0.4|||||Degree|||0.4|-0.6|
73829841|NCT02966834|147206338|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Direction|||0.7|-0.7|
73829842|NCT02966834|147206338|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||||Direction|||0.6|-0.7|
73829843|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.5|||||Direction|||0.5|-0.8|
73829844|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2|||||Direction|||0.2|-1.0|
73829845|NCT02966834|147206338|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||||Direction|||0.6|-0.6|
73829846|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.1|0.3|||||Disability|||0.3|-1.1|
73829847|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.5|||||Disability|||0.5|-0.8|
73829848|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
73829849|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
73829850|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
73829851|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.3|||||Distribution|||0.3|-0.9|
73829852|NCT02966834|147206338|OTHER||Median Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.2|||||Distribution|||0.2|-0.9|
73829853|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||||Distribution|||0.0|-1.0|
73829854|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.2|||||Distribution|||0.2|-0.9|
73829855|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.7|0.3|||||Distribution|||0.3|-0.7|
73829856|NCT02966834|147206338|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-3.3|1.3|||||5-D Itch Total Score|||1.3|-3.3|
73829857|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-2.2|2.1|||||5-D Itch Total Score|||2.1|-2.2|
73829858|NCT02966834|147206338|OTHER||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-3.5|0.7|||||5-D Itch Total Score|||0.7|-3.5|
73829859|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-3.0|1.2|||||5-D Itch Total Score|||1.2|-3.0|
73829860|NCT02966834|147206338|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.7|1.6|||||5-D Itch Total Score|||1.6|-2.7|
73829861|NCT02966834|147206342|OTHER||Mean Difference (Net)|-0.71|||||TWO_SIDED|95.0|-1.69|0.28||||||||0.28|-1.69|
73829862|NCT02966834|147206342|OTHER||Mean Difference (Net)|-0.62|||||TWO_SIDED|95.0|-1.49|0.26||||||||0.26|-1.49|
73829863|NCT02966834|147206342|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-1.76|-0.03||||||||-0.03|-1.76|
73829864|NCT02966834|147206342|OTHER||Mean Difference (Net)|-1.16|||||TWO_SIDED|95.0|-2.05|-0.28||||||||-0.28|-2.05|
73829865|NCT02966834|147206342|OTHER||Mean Difference (Net)|-0.95|||||TWO_SIDED|95.0|-1.85|-0.06||||||||-0.06|-1.85|
73829866|NCT02966834|147206343|OTHER||Least Square (LS) mean ratio|0.967|||||TWO_SIDED|95.0|0.635|1.471||||||||1.471|0.635|
73829867|NCT02966834|147206343|OTHER||LS mean ratio|1.17|||||TWO_SIDED|95.0|0.8|1.712||||||||1.712|0.8|
73829868|NCT02966834|147206343|OTHER||LS mean ratio|0.909|||||TWO_SIDED|95.0|0.627|1.316||||||||1.316|0.627|
73829869|NCT02966834|147206343|OTHER||LS mean ratio|0.69|||||TWO_SIDED|95.0|0.474|1.005||||||||1.005|0.474|
73829870|NCT02966834|147206343|OTHER||LS mean ratio|0.825|||||TWO_SIDED|95.0|0.564|1.207||||||||1.207|0.564|
73829871|NCT02966834|147206344|OTHER||LS mean ratio|1.363|||||TWO_SIDED|95.0|0.932|1.995||||||||1.995|0.932|
73829872|NCT02966834|147206344|OTHER||LS mean ratio|2.05|||||TWO_SIDED|95.0|1.456|2.887||||||||2.887|1.456|
73829873|NCT02966834|147206344|OTHER||LS mean ratio|2.457|||||TWO_SIDED|95.0|1.758|3.436||||||||3.436|1.758|
73829874|NCT02966834|147206344|OTHER||LS mean ratio|3.128|||||TWO_SIDED|95.0|2.206|4.435||||||||4.435|2.206|
73829875|NCT02966834|147206344|OTHER||LS mean ratio|2.701|||||TWO_SIDED|95.0|1.915|3.81||||||||3.81|1.915|
73896548|NCT03456882|147326410|SUPERIORITY||difference between mean slopes|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0319|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 eating and drinking. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.0319
73829876|NCT03729362|147206398|SUPERIORITY|Analysis used a mixed-effect model for repeated measures (MMRM). The model included terms for treatment, baseline 6MWD, age, height, weight (all as continuous covariates), enzyme replacement therapy (ERT) status (ERT-naïve versus ERT-experienced), gender, time, and treatment-by-time interaction. Time was used as a repeated measure, and an unstructured covariance approach was applied.|LS Mean Difference|14.21|STANDARD_ERROR_OF_MEAN|8.481||0.048|TWO_SIDED|95.0|-2.6|31.02||1-sided significance level of 0.025.|MMRM|||"The primary and key secondary endpoints were tested in hierarchical order as follows:~The test for the primary endpoint was conducted first at the 1-sided 0.025 significance level, and if significant, the ordered key secondary endpoints were similarly tested. If at any point the null hypothesis for superiority failed to be rejected, then that comparison and any other comparison below it could not be claimed as successful and would be considered nominal."||31.02|-2.6|0.048
73829877|NCT03729362|147206399|SUPERIORITY|The analysis used an Analysis of Covariance (ANCOVA) model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|1.156||0.012|TWO_SIDED|95.0|0.37|4.95||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in sitting FVC was the first of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||4.95|0.37|0.012
73829878|NCT03729362|147206400|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.727||0.095|TWO_SIDED|95.0|-0.48|2.4||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in the MMT score for the lower extremities was the second of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||2.4|-0.48|0.095
73829879|NCT03729362|147206401|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|8.17|STANDARD_ERROR_OF_MEAN|6.261||0.097|TWO_SIDED|95.0|-4.24|20.57||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 26 in 6MWD was the third of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||20.57|-4.24|0.097
73829880|NCT03729362|147206402|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|1.706||0.138|TWO_SIDED|95.0|-1.51|5.25||1-sided significance level of 0.025|ANCOVA|||Change from baseline to Week 52 in the total score for the PROMIS® - Physical Function was the fourth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||5.25|-1.51|0.138
73829881|NCT03729362|147206403|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|1.092||0.515|TWO_SIDED|95.0|-2.12|2.2||1-sided significance level of 0.025|ANCOVA|||Change from baseline to Week 52 in the total score for the PROMIS® - Fatigue was the fifth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||2.2|-2.12|0.515
73829882|NCT03729362|147206404|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|-1.414|STANDARD_ERROR_OF_MEAN|0.528||0.004|TWO_SIDED|95.0|-2.463|-0.364||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in the total score for the GSGC was the sixth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||-0.364|-2.463|0.004
73829883|NCT03427892|147206444|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
73829884|NCT03427892|147206445|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.93||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.93
73896549|NCT03456882|147326410|SUPERIORITY||difference between mean slopes|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.6419|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 communication. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.6419
73829885|NCT03427892|147206446|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.49||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is RAVLT Score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.49
73829886|NCT03427892|147206446|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.56||||||Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.Reported is delay score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.56
73829887|NCT03427892|147206447|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.221||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. Reported is CW score.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.221
73829888|NCT03427892|147206447|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.306||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.Reported is Inter. score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.306
73829889|NCT03427892|147206448|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.07||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is TMT A.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.07
73829890|NCT03427892|147206448|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.19||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.The above reported is TMT B.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.19
73896550|NCT03456882|147326410|SUPERIORITY||difference between mean slopes|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.3951|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 emotional reactions. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.3951
73829891|NCT03427892|147206449|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
73829892|NCT03427892|147206450|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.022||||||To analyze separate one-way repeated measures analyses of variance (ANOVA) were performed. Time (baseline, week 4, week 8) was included as the within-subject factor.Above is from baseline to week 8 for C-SSRS AA, IA, and ABA.|ANOVA|One-way repeated measures (ANOVA) were performed. Time (baseline, wk 4, wk 8) included as within-subject factor. Above is for C-SSRS AA,IA, and ABA.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.022
73829893|NCT03427892|147206450|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.163||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.163
73829894|NCT03427892|147206451|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.133||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.133
73896551|NCT03456882|147326411|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|3.8||0.9563|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.9563
73896552|NCT03456882|147326412|SUPERIORITY||Mean Difference (Net)|28.5|STANDARD_ERROR_OF_MEAN|23.4||0.2253|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.2253
73829895|NCT03427892|147206452|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.002
73829896|NCT03427892|147206453|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.002
73829897|NCT03427892|147206454|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.005||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.005
73829898|NCT03427892|147206455|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
73829899|NCT03427892|147206456|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.295||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.295
73829900|NCT02314546|147206463|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|||||||0.99
73829901|NCT02314546|147206464|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|||||||0.99
73829902|NCT02314546|147206465|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Kruskal-Wallis|||||||0.26
73829903|NCT02314546|147206466|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Kruskal-Wallis|||||||0.02
73829904|NCT02314546|147206467|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Kruskal-Wallis|||||||0.04
73829905|NCT02314546|147206468|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
73829906|NCT02314546|147206469|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
73829907|NCT00274456|147206470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.224||95.0||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site||Independent reader assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.||||0.224
73829908|NCT00274456|147206470|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH was stratified by study site||Investigator assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.||||<0.001
73829909|NCT00274456|147206470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR||||0.002
73829910|NCT00274456|147206470|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||<0.001
73829911|NCT00274456|147206470|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR||||>0.05
73829912|NCT00274456|147206470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.024
73829913|NCT00274456|147206470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.099||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.099
73829914|NCT00274456|147206470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.002
73829915|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.027
73829916|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.009
73829917|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.017
73829918|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
73829919|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
73829920|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
73829921|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.085|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.085
73829922|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparison was performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed disease control rate (DCR), ie, SD \>= 16 weeks, or CR or PR||||0.007
73829923|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||>0.05
73829924|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.009
73829925|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.005
73829926|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||>0.05
73829927|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.098
73829928|NCT00274456|147206471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.014
73829929|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0498||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank|||Independent assessment||||0.0498
73829930|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.607||||0.0524|||||||Log Rank|||Independent assessment||||0.0524
73829931|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.495||||0.0065|||||||Log Rank|||Independent assessment||||0.0065
73829932|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
73829933|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
73829934|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
73829935|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
73829936|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment||||0.008
73829937|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
73829938|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
73829939|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.568||||0.012|||||||Log Rank|||Investigator assessment||||0.012
73829940|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.972||||0.001|||||||Log Rank|||Investigator assessment||||0.001
73829941|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.702||||0.076|||||||Log Rank|||Investigator assessment||||0.076
73829942|NCT00274456|147206472|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
73829943|NCT00274456|147206473|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Independent assessment||||>0.05
73829944|NCT00274456|147206474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment||||0.013
73829945|NCT00274456|147206474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||Log Rank|||Investigator assessment||||0.022
73829946|NCT00274456|147206474|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
73829947|NCT00274456|147206474|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
73829948|NCT00274456|147206474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Log Rank|||Investigator assessment||||0.005
73829949|NCT00274456|147206474|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
73829950|NCT00274456|147206474|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
73829951|NCT00274456|147206475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank|||||||0.047
73829952|NCT00274456|147206475|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
73829953|NCT00274456|147206475|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
73829954|NCT00274456|147206475|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
73829955|NCT00274456|147206475|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.686||||0.069||95.0|||||Log Rank|||||||0.069
73829956|NCT00274456|147206475|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
73829957|NCT00274456|147206475|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.74||||0.008||95.0|||||Log Rank|||||||0.008
73829958|NCT00375752|147206498|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.7||||0.106|TWO_SIDED|95.0|-1.8|31.1|||Fisher Exact|||||31.1|-1.8|0.106
73829959|NCT02034006|147206503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|72.37|||<|0.0001|TWO_SIDED|95.0|23.44|223.42|||Regression, Logistic|||Presence vs. absence of active leakage.||223.42|23.44|<0.0001
73829960|NCT02034006|147206509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.33|||<|0.0001|TWO_SIDED|95.0|3.18|27.36|||Regression, Logistic|||Presence vs. absence of macular edema.||27.36|3.18|<0.0001
73829961|NCT02034006|147206510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.66|||<|0.0001|TWO_SIDED|95.0|3.76|42.67|||Regression, Logistic|||Presence vs. absence of cysts.||42.67|3.76|<0.0001
73829962|NCT02034006|147206511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.8|||<|0.0001|TWO_SIDED|95.0|11.62|213.5|||Regression, Logistic|||Presence vs. absence of intra-retinal fluid.||213.50|11.62|<0.0001
73829963|NCT02034006|147206512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.1514|TWO_SIDED|95.0|0.99|1.0|||Regression, Logistic|||Change in Central subfield thickness vs previous visit.||1.00|0.99|0.1514
73829964|NCT02034006|147206513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.1265|TWO_SIDED|95.0|0.0|5.63|||Regression, Logistic|||Change in Central subfield volume vs previous visit.||5.63|0.00|0.1265
73829965|NCT02034006|147206515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.91||||0.0103|TWO_SIDED|95.0|1.58|30.23|||Regression, Logistic|||Presence vs. absence of clinically significant abnormalities.||30.23|1.58|0.0103
73829966|NCT02034006|147206516|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0854|TWO_SIDED|95.0|0.9|5.33|||Regression, Logistic|||Gain \< 5 letters vs. Gain \>= 5 letters.||5.33|0.90|0.0854
73829967|NCT02034006|147206517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.52||||0.0114|TWO_SIDED|95.0|1.23|5.17|||Regression, Logistic|||Gain \< 10 letters vs. Gain \>= 10 letters.||5.17|1.23|0.0114
73829968|NCT02034006|147206518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.0049|TWO_SIDED|95.0|0.25|0.91|||Regression, Logistic|||Change from baseline in BCVA: Improved vs. No change. For retreated subjects, the last scheduled assessment prior to the first retreatment was considered. For subjects treated only once, the last scheduled assessment available was considered.||0.91|0.25|0.0049
73829969|NCT02034006|147206518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53||||0.0461|TWO_SIDED|95.0|0.69|44.52|||Regression, Logistic|||Change from baseline in BCVA: Worsened vs. No change||44.52|0.69|0.0461
73829970|NCT02100631|147206551|NON_INFERIORITY|The lower limit of the two sided 95% Wald CI on the difference in seroconversion rate was estimated by inverting a Z test with pooled variance. The lower limit of the CI had be greater than -10 percentage points to prove non-inferiority. The lower bound of the CI on the older adults serconversion rate was required to exceed 70%.|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-6.7|0.4||||||||0.4|-6.7|
73829971|NCT02100631|147206552|OTHER||Geometric Mean Ratio (GMR)|0.44|||||TWO_SIDED|95.0|0.34|0.57||||||||0.57|0.34|
73829972|NCT02100631|147206553|NON_INFERIORITY|Analysis for information only. No non-inferiority margin specified.|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-2.2|3.5||||||||3.5|-2.2|
73829973|NCT02100631|147206554|NON_INFERIORITY|Analysis for information only. No non-inferiority margin specified.||||||0.0062|||||||t-test, 2 sided|||||||0.0062
73829974|NCT01721798|147206591|NON_INFERIORITY|Primary Outcome Analysis: Proportion of women with detectable genital viral load across 24 months|Odds Ratio (OR)|0.87||||0.66|TWO_SIDED|95.0|0.47|1.62|||GEE|||C-IUD is comparator group.||1.62|0.47|0.66
73829975|NCT01721798|147206592|NON_INFERIORITY|Secondary Outcome Analysis of Proportion with Detectable plasma viral load users at 24 months|Odds Ratio (OR)|0.83||||0.64|TWO_SIDED|95.0|0.37|1.86|||GEE|Adjusted as-treated analysis||C-IUD is comparator group.||1.86|0.37|0.64
73829976|NCT01721798|147206594|NON_INFERIORITY|Secondary Outcome Analysis of Allocated IUC continuation at 24 months|Hazard Ratio (HR)|8.61|||<|0.001|TWO_SIDED|95.0|3.03|24.4|||Regression, Cox|||C-IUD is comparator group.||24.4|3.03|<0.001
73829977|NCT03104413|147206697|SUPERIORITY||Adjusted Risk Difference|22.1|||<|0.001|TWO_SIDED|95.0|13.1|31.0|||Cochran-Mantel-Haenszel|||||31.0|13.1|<0.001
73829978|NCT03104413|147206697|SUPERIORITY||Adjusted Risk Difference|20.5|||<|0.001|TWO_SIDED|95.0|11.6|29.5|||Cochran-Mantel-Haenszel|||||29.5|11.6|< 0.001
73829979|NCT03104413|147206698|SUPERIORITY||Adjusted Risk Difference|17.6|||<|0.001|TWO_SIDED|95.0|9.9|25.4|||Cochran-Mantel-Haenszel|||||25.4|9.9|< 0.001
73829980|NCT03104413|147206698|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.1|||Cochran-Mantel-Haenszel|||||31.1|15.1|<0.001
73829981|NCT03104413|147206699|SUPERIORITY||Adjusted Risk Difference|17.6|||<|0.001|TWO_SIDED|95.0|9.9|25.4|||Cochran-Mantel-Haenszel|||||25.4|9.9|<0.001
73829982|NCT03104413|147206699|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.1|||Cochran-Mantel-Haenszel|||||31.1|15.1|<0.001
73829983|NCT03104413|147206700|SUPERIORITY||Adjusted Risk Difference|15.2||||0.001|TWO_SIDED|95.0|6.4|24.0|||Cochran-Mantel-Haenszel|||||24.0|6.4|0.001
73829984|NCT03104413|147206700|SUPERIORITY||Adjusted Risk Difference|20.4|||<|0.001|TWO_SIDED|95.0|11.5|29.3|||Cochran-Mantel-Haenszel|||||29.3|11.5|<0.001
73829985|NCT03104413|147206701|SUPERIORITY||Adjusted Risk Difference|15.7||||0.001|TWO_SIDED|95.0|6.8|24.6|||Cochran-Mantel-Haenszel|||||24.6|6.8|0.001
73829986|NCT03104413|147206701|SUPERIORITY||Adjusted Risk Difference|11.8||||0.008|TWO_SIDED|95.0|3.0|20.5|||Cochran-Mantel-Haenszel|||||20.5|3.0|0.008
73829987|NCT03104413|147206702|SUPERIORITY||Adjusted Risk Difference|29.4|||<|0.001|TWO_SIDED|95.0|19.9|39.0|||Cochran-Mantel-Haenszel|||||39.0|19.9|< 0.001
73829988|NCT03104413|147206702|SUPERIORITY||Adjusted Risk Difference|30.6|||<|0.001|TWO_SIDED|95.0|21.1|40.1|||Cochran-Mantel-Haenszel|||||40.1|21.1|<0.001
73829989|NCT03104413|147206703|SUPERIORITY||LS Mean Difference|2.8||||0.02|TWO_SIDED|95.0|0.4|5.1|||Mixed-Effect Model Repeat Measurement|||||5.1|0.4|0.020
73829990|NCT03104413|147206703|SUPERIORITY||LS Mean Difference|3.0||||0.01|TWO_SIDED|95.0|0.7|5.3|||Mixed-Effect Model Repeat Measurement|||||5.3|0.7|0.010
73829991|NCT03104413|147206704|SUPERIORITY||Adjusted Risk Difference|9.6||||0.01|TWO_SIDED|95.0|2.3|16.9|||Cochran-Mantel-Haenszel|||||16.9|2.3|0.010
73829992|NCT03104413|147206704|SUPERIORITY||Adjusted Risk Difference|8.2||||0.023|TWO_SIDED|95.0|1.1|15.3|||Cochran-Mantel-Haenszel|||||15.3|1.1|0.023
73829993|NCT03104413|147206705|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.5|21.5|||Cochran-Mantel-Haenszel|||||21.5|8.5|<0.001
73829994|NCT03104413|147206705|SUPERIORITY||Adjusted Risk Difference|17.8|||<|0.001|TWO_SIDED|95.0|11.1|24.5|||Cochran-Mantel-Haenszel|||||24.5|11.1|<0.001
73829995|NCT03104413|147206706|SUPERIORITY||Adjusted Risk Difference|17.5|||<|0.001|TWO_SIDED|95.0|8.0|26.9|||Cochran-Mantel-Haenszel|||||26.9|8.0|<0.001
73829996|NCT03104413|147206706|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|10.8|29.8|||Cochran-Mantel-Haenszel|||||29.8|10.8|<0.001
73829997|NCT03104413|147206707|SUPERIORITY||Adjusted Risk Difference|21.8|||<|0.001|TWO_SIDED|95.0|12.1|31.6|||Cochran-Mantel-Haenszel|||||31.6|12.1|<0.001
73829998|NCT03104413|147206707|SUPERIORITY||Adjusted Risk Difference|22.7|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
73829999|NCT03104413|147206708|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.9|21.2|||Cochran-Mantel-Haenszel|||||21.2|8.9|<0.001
73830000|NCT03104413|147206708|SUPERIORITY||Adjusted Risk Difference|16.2|||<|0.001|TWO_SIDED|95.0|9.9|22.4|||Cochran-Mantel-Haenszel|||||22.4|9.9|<0.001
73830001|NCT03104413|147206709|SUPERIORITY||Adjusted Risk Difference|13.6||||0.006|TWO_SIDED|95.0|4.0|23.3|||Cochran-Mantel-Haenszel|||||23.3|4.0|0.006
73830002|NCT03104413|147206709|SUPERIORITY||Adjusted Risk Difference|7.1||||0.142|TWO_SIDED|95.0|-2.4|16.6|||Cochran-Mantel-Haenszel|||||16.6|-2.4|0.142
73830003|NCT03104413|147206710|SUPERIORITY||Adjusted Risk Difference|9.4||||0.001|TWO_SIDED|95.0|3.8|15.1|||Cochran-Mantel-Haenszel|||||15.1|3.8|0.001
73830004|NCT03104413|147206710|SUPERIORITY||Adjusted Risk Difference|11.2|||<|0.001|TWO_SIDED|95.0|5.3|17.0|||Cochran-Mantel-Haenszel|||||17.0|5.3|<0.001
73830005|NCT03104413|147206711|SUPERIORITY||Adjusted Risk Difference|22.8|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
73830006|NCT03104413|147206711|SUPERIORITY||Adjusted Risk Difference|20.0|||<|0.001|TWO_SIDED|95.0|10.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|10.2|<0.001
73830007|NCT03104413|147206712|SUPERIORITY||Adjusted Risk Difference|5.6||||0.377|TWO_SIDED|95.0|-6.8|17.9|||Cochran-Mantel-Haenszel|||||17.9|-6.8|0.377
73830008|NCT03104413|147206712|SUPERIORITY||Adjusted Risk Difference|13.4||||0.039|TWO_SIDED|95.0|0.7|26.1|||Cochran-Mantel-Haenszel|||||26.1|0.7|0.039
73830009|NCT03104413|147206713|SUPERIORITY||Risk Difference (RD)|-8.1||||0.002|TWO_SIDED|95.0|-13.2|-2.9|||Chi-squared|||||-2.9|-13.2|0.002
73830010|NCT03104413|147206713|SUPERIORITY||Risk Difference (RD)|-9.1|||<|0.001|TWO_SIDED|95.0|-14.1|-4.2|||Chi-squared|||||-4.2|-14.1|<0.001
73830011|NCT03104413|147206714|SUPERIORITY||Risk Difference (RD)|-6.2||||1|TWO_SIDED|95.0|-28.1|15.7|||Chi-squared|||||15.7|-28.1|1
73830012|NCT03104413|147206714|SUPERIORITY||Risk Difference (RD)|30.4||||0.113|TWO_SIDED|95.0|0.6|60.2|||Chi-squared|||||60.2|0.6|0.113
73830013|NCT03104413|147206715|SUPERIORITY||Adjusted Risk Difference|22.1|||<|0.001|TWO_SIDED|95.0|13.1|31.0|||Cochran-Mantel-Haenszel|||||31.0|13.1|<0.001
73830014|NCT03104413|147206715|SUPERIORITY||Adjusted Risk Difference|20.5|||<|0.001|TWO_SIDED|95.0|11.6|29.5|||Cochran-Mantel-Haenszel|||||29.5|11.6|<0.001
73830015|NCT03104413|147206716|SUPERIORITY||Adjusted Risk Difference|15.7||||0.001|TWO_SIDED|95.0|6.8|24.6|||Cochran-Mantel-Haenszel|||||24.6|6.8|0.001
73830016|NCT03104413|147206716|SUPERIORITY||Adjusted Risk Difference|11.8||||0.008|TWO_SIDED|95.0|3.0|20.5|||Cochran-Mantel-Haenszel|||||20.5|3|0.008
73830017|NCT03104413|147206717|SUPERIORITY||Adjusted Risk Difference|9.2||||0.006|TWO_SIDED|95.0|2.6|15.7|||Cochran-Mantel-Haenszel|||||15.7|2.6|0.006
73830018|NCT03104413|147206717|SUPERIORITY||Adjusted Risk Difference|10.3||||0.002|TWO_SIDED|95.0|3.7|16.8|||Cochran-Mantel-Haenszel|||||16.8|3.7|0.002
73830019|NCT03104413|147206718|SUPERIORITY||Adjusted Risk Difference|29.4|||<|0.001|TWO_SIDED|95.0|19.9|39.0|||Cochran-Mantel-Haenszel|||||39.0|19.9|<0.001
73830020|NCT03104413|147206718|SUPERIORITY||Adjusted Risk Difference|30.6|||<|0.001|TWO_SIDED|95.0|21.1|40.1|||Cochran-Mantel-Haenszel|||||40.1|21.1|<0.001
73830021|NCT03104413|147206719|SUPERIORITY||LS Mean Difference|2.8||||0.02|TWO_SIDED|95.0|0.4|5.1|||Mixed-Effect Model Repeat Measurement|||||5.1|0.4|0.020
73830022|NCT03104413|147206719|SUPERIORITY||LS Mean Difference|3.0||||0.01|TWO_SIDED|95.0|0.7|5.3|||Mixed-Effect Model Repeat Measurement|||||5.3|0.7|0.010
73830023|NCT03104413|147206720|SUPERIORITY||LS Mean Difference|12.4||||0.001|TWO_SIDED|95.0|5.0|19.8|||Mixed-Effect Model Repeat Measurement|||||19.8|5.0|0.001
73830024|NCT03104413|147206720|SUPERIORITY||LS Mean Difference|15.0|||<|0.001|TWO_SIDED|95.0|7.7|22.4|||Mixed-Effect Model Repeat Measurement|||||22.4|7.7|<0.001
73830025|NCT03104413|147206721|SUPERIORITY||Adjusted Risk Difference|13.9|||<|0.001|TWO_SIDED|95.0|7.1|20.7|||Cochran-Mantel-Haenszel|||||20.7|7.1|<0.001
73830026|NCT03104413|147206721|SUPERIORITY||Adjusted Risk Difference|17.3|||<|0.001|TWO_SIDED|95.0|10.3|24.2|||Cochran-Mantel-Haenszel|||||24.2|10.3|<0.001
73830027|NCT03104413|147206722|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.9|21.2|||Cochran-Mantel-Haenszel|||||21.2|8.9|<0.001
73830028|NCT03104413|147206722|SUPERIORITY||Adjusted Risk Difference|16.2|||<|0.001|TWO_SIDED|95.0|9.9|22.4|||Cochran-Mantel-Haenszel|||||22.4|9.9|<0.001
73830029|NCT03104413|147206723|SUPERIORITY||Adjusted Risk Difference|13.6||||0.006|TWO_SIDED|95.0|4.0|23.3|||Cochran-Mantel-Haenszel|||||23.3|4|0.006
73830030|NCT03104413|147206723|SUPERIORITY||Adjusted Risk Difference|7.1||||0.142|TWO_SIDED|95.0|-2.4|16.6|||Cochran-Mantel-Haenszel|||||16.6|-2.4|0.142
73830031|NCT03104413|147206724|SUPERIORITY||Adjusted Risk Difference|9.4||||0.001|TWO_SIDED|95.0|3.8|15.1|||Cochran-Mantel-Haenszel|||||15.1|3.8|0.001
73830032|NCT03104413|147206724|SUPERIORITY||Adjusted Risk Difference|11.2|||<|0.001|TWO_SIDED|95.0|5.3|17.0|||Cochran-Mantel-Haenszel|||||17.0|5.3|<0.001
73830033|NCT03104413|147206725|SUPERIORITY||Adjusted Risk Difference|22.8|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
73830034|NCT03104413|147206725|SUPERIORITY||Adjusted Risk Difference|20.0|||<|0.001|TWO_SIDED|95.0|10.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|10.2|<0.001
73830035|NCT03104413|147206726|SUPERIORITY||Adjusted Risk Difference|5.6||||0.377|TWO_SIDED|95.0|-6.8|17.9|||Cochran-Mantel-Haenszel|||||17.9|-6.8|0.377
73830036|NCT03104413|147206726|SUPERIORITY||Adjusted Risk Difference|13.4||||0.039|TWO_SIDED|95.0|0.7|26.1|||Cochran-Mantel-Haenszel|||||26.1|0.7|0.039
73830037|NCT03104413|147206727|SUPERIORITY||LS Mean Difference|-8.1||||0.002|TWO_SIDED|95.0|-13.2|-2.9|||Mixed-Effect Model Repeat Measurement|||||-2.9|-13.2|0.002
73830038|NCT03104413|147206727|SUPERIORITY||LS Mean Difference|-9.1|||<|0.001|TWO_SIDED|95.0|-14.1|-4.2|||Mixed-Effect Model Repeat Measurement|||||-4.2|-14.1|<0.001
73830039|NCT03104413|147206728|SUPERIORITY||LS Mean Difference|-6.2||||1|TWO_SIDED|95.0|-28.1|15.7|||Mixed-Effect Model Repeat Measurement|||||15.7|-28.1|1.00
73830040|NCT03104413|147206728|SUPERIORITY||LS Mean Difference|30.4||||0.113|TWO_SIDED|95.0|0.6|60.2|||Mixed-Effect Model Repeat Measurement|||||60.2|0.6|0.113
73830041|NCT03104413|147206729|SUPERIORITY||LS Mean Difference|-7.323||||0.113|TWO_SIDED|95.0|-16.399|1.753|||Mixed-Effect Model Repeat Measurement|||||1.753|-16.399|0.113
73830042|NCT03104413|147206729|SUPERIORITY||LS Mean Difference|-8.759||||0.05|TWO_SIDED|95.0|-17.518|-0.001|||Mixed-Effect Model Repeat Measurement|||||-0.001|-17.518|0.050
73830043|NCT03104413|147206730|SUPERIORITY||LS Mean Difference|2.221||||0.008|TWO_SIDED|95.0|0.577|3.865|||Mixed-Effect Model Repeat Measurement|||||3.865|0.577|0.008
73830044|NCT03104413|147206730|SUPERIORITY||LS Mean Difference|2.714||||0.001|TWO_SIDED|95.0|1.077|4.351|||Mixed-Effect Model Repeat Measurement|||||4.351|1.077|0.001
73830045|NCT03104413|147206731|SUPERIORITY||Adjusted Risk Difference|15.2||||0.001|TWO_SIDED|95.0|6.4|24.0|||Cochran-Mantel-Haenszel|||||24|6.4|0.001
73830046|NCT03104413|147206731|SUPERIORITY||Adjusted Risk Difference|20.4|||<|0.001|TWO_SIDED|95.0|11.5|29.3|||Cochran-Mantel-Haenszel|||||29.3|11.5|<0.001
73830047|NCT02765035|147206732|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||C-Leg 3 vs. NMPK (Baseline)||||0.01
73830048|NCT02765035|147206732|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|||C-Leg 4 vs. NMPK (Baseline)||||0.04
73830049|NCT00091819|147206755|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|1.0||||||95.0|-4.8|6.8||p-values were not calculated in deference to confidence intervals.|||"Statistical analysis applies to cure"|||6.8|-4.8|
73830050|NCT00984867|147206756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.62|-0.34||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives, based on data from both strata combined|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-0.34|-0.62|<0.0001
73830051|NCT00984867|147206757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.2466|<|0.0001|TWO_SIDED|95.0|-2.37|-1.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-1.40|-2.37|<0.0001
73830052|NCT00984867|147206758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.1106|<|0.0001|TWO_SIDED|95.0|-1.05|-0.62||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-0.62|-1.05|<0.0001
73830053|NCT00984867|147206759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.92|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|-34.45|-21.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-21.40|-34.45|<0.0001
73830054|NCT00984867|147206760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|1.4659||0.5583||95.0|-3.75|2.03||Not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||2.03|-3.75|0.5583
73830055|NCT00984867|147206761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.82|STANDARD_ERROR_OF_MEAN|3.516|||TWO_SIDED|95.0|-21.73|-7.9||Not significant. Hierarchical testing procedure stopped at previous endpoint|ANCOVA|with treatment group and stratum as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-7.90|-21.73|
73830056|NCT00984867|147206762|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|41.2|||TWO_SIDED|95.0|11.1|26.4||Not significant. Hierarchical testing procedure stopped at previous endpoint|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0.||26.4|11.1|
73830057|NCT00204737|147206768|OTHER|||||||0.06|||||||Fisher Exact|||comparison at 2 Weeks||||0.06
73830058|NCT00204737|147206768|OTHER|||||||0.18|||||||Fisher Exact|||Comparison at 6 Weeks||||0.18
73830059|NCT00204737|147206768|OTHER|||||||0.5|||||||Fisher Exact|||Comparison at 12 weeks||||0.5
73830060|NCT01206764|147206853|OTHER|Kaplan Meier|Median Difference (Net)|27.71|||||TWO_SIDED|95.0|21.86|35.29||||||Single arm open label study||35.29|21.86|
73830061|NCT01206764|147206857|OTHER|Kaplan Meier|Median Difference (Net)|45.71|||||TWO_SIDED|95.0|31.29|106.43||||||The median overall survival was not evaluable, this presents the 25th percentile of overall survival||106.43|31.29|
73830062|NCT05824026|147206880|OTHER||||||||||||||||||"The purpose of the primary analysis was to show non-inferiority to the performance of a historical control (a silver containing gelling fiber) on proportion of wounds healed, 77%, with a non-inferiority margin of 20%. Non-inferiority was demonstrated if the lower limit of the 95% confidence interval is above 57%. An exact confidence interval for the proportion was applied. In the primary analysis missing data was not included. In the post hoc sensitivity analysis missing data was imputed using multiple imputation for 3 wounds where data was assumed to be missing at random, and otherwise imputed as wound not healed.~The supplemental analysis addressed a more conservative analysis than performed for the historical control. Hence, no formal non-inferiority criteria was applied for this analysis."|||
73830063|NCT02855268|147206897|SUPERIORITY||Least square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|3.27||0.9472|TWO_SIDED|95.0|-6.92|6.48||Threshold of significance was 1-sided \<0.025.|Linear mixed effect model|||Annualized rate of change in eGFR during the placebo-controlled treatment period was compared between lademirsen and placebo using a random coefficient linear mixed effect model which included time as a continuous variable.||6.48|-6.92|0.9472
73830064|NCT05033041|147206940|EQUIVALENCE|Equivalence is based on an equivalence hypothesis of -17mL \<difference in differences \< 17mL.||||||0.001|||||||t-test, 1 sided|||Comparison of the means using two one-sided t tests (TOST)||||.001
73830065|NCT00320086|147206995|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||ANOVA||||<0.05
73830066|NCT00576758|147207003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.26||||0.1587|TWO_SIDED|60.0|3.9|18.7|||Chi-squared|||||18.7|3.9|0.1587
73830067|NCT00576758|147207004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83|||||TWO_SIDED|95.0|-2.9|16.6||||||||16.6|-2.9|
73830068|NCT00576758|147207008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||||TWO_SIDED|95.0|-13.9|18.3||||||||18.3|-13.9|
73830069|NCT00576758|147207009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.62|1.44||||||||1.44|0.62|
73830070|NCT00576758|147207011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.67|1.5||||||||1.50|0.67|
73830071|NCT00089648|147207027|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|23.0||||||95.0|13.2|35.5|||||ORR=proportion of subjects with confirmed CR or PR, relative to total number of subjects who received at least 1 dose of study medication, were refractory to bevacizumab, had a baseline disease assessment and had the correct histological cancer type.|||35.5|13.2|
73830072|NCT03183908|147207042|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 5%, stratified by site.|Difference in proportions|-2.7|||||TWO_SIDED|95.0|-5.8|0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|The null hypothesis is allV3 is inferior (i.e., allV3 will have higher rates of moderate/severe injection site pain) to IIV3-HD in regards to the proportion of subjects having moderate or severe injection site pain in the first week post vaccination.||0.4|-5.8|
73830073|NCT03183908|147207044|OTHER|The comparison of the number of participants with reported SAEs regardless of relationship to study product were made using 95% confidence intervals. Results were reported using exact binomial confidence intervals.|Comparison of Frequencies|2.38|||||TWO_SIDED|95.0|1.09|4.47||||||||4.47|1.09|
73830074|NCT03183908|147207044|OTHER|The comparison of the number of participants with reported SAEs regardless of relationship to study product were made using 95% confidence intervals. Results were reported using exact binomial confidence intervals.|Comparison of Frequencies|0.79|||||TWO_SIDED|95.0|0.16|2.23||||||||2.23|0.16|
73830075|NCT03183908|147207045|NON_INFERIORITY|This objective will be assessed using a one-sided noninferiority test with the alpha level set at 0.025 and noninferiority margin of 10%. The null hypothesis is the allV3 H3N2 seroconversion rate is inferior to IIV3-HD seroconversion rate.|Difference in Proportions|-0.0579||||0.1245|ONE_SIDED|97.5|-0.1291||||Cochran-Mantel-Haenszel||The directional comparison was the lower bound of the confidence interval using a 10% non-inferiority margin.||||-.1291|0.1245
73830076|NCT03183908|147207046|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-1.9|||||TWO_SIDED|98.0|-5.0|1.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||1.0|-5.0|
73830077|NCT03183908|147207046|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-3.1|4.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||4.3|-3.1|
73830078|NCT03183908|147207046|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-3.7|||||TWO_SIDED|98.0|-7.5|-0.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||-0.3|-7.5|
73830079|NCT03183908|147207046|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.6|||||TWO_SIDED|98.0|-2.7|5.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||5.9|-2.7|
73830080|NCT03183908|147207047|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.4|||||TWO_SIDED|95.0|-5.2|0.2|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||0.2|-5.2|
73830081|NCT03183908|147207047|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.3|4.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||4.9|-2.3|
73830082|NCT03183908|147207047|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-4.5|||||TWO_SIDED|95.0|-8.1|-1.1|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||-1.1|-8.1|
73830083|NCT03183908|147207047|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.7|5.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||5.9|-2.7|
73830084|NCT03183908|147207047|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-3.1|||||TWO_SIDED|95.0|-6.9|0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Injection Site Pain||0.4|-6.9|
73830085|NCT03183908|147207048|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.3|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||7.3|-7.3|
73830086|NCT03183908|147207048|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.3|||||TWO_SIDED|95.0|-9.5|5.7|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||5.7|-9.5|
73830087|NCT03183908|147207048|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.2|||||TWO_SIDED|95.0|-8.6|6.1|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||6.1|-8.6|
73830088|NCT03183908|147207048|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.7|8.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||8.3|-5.7|
73830089|NCT03183908|147207048|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.2|||||TWO_SIDED|95.0|-7.9|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Injection Site Pain||5.4|-7.9|
73830090|NCT03183908|147207049|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.8|||||TWO_SIDED|98.0|-1.7|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||5.4|-1.7|
73830091|NCT03183908|147207049|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.5|||||TWO_SIDED|98.0|-2.8|2.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Chills/Shivering||2.3|-2.8|
73830092|NCT03183908|147207049|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-1.1|||||TWO_SIDED|98.0|-4.0|1.5|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||1.5|-4.0|
73830093|NCT03183908|147207049|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|3.2|||||TWO_SIDED|98.0|-0.8|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||7.3|-0.8|
73830094|NCT03183908|147207049|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-2.5|2.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||2.0|-2.5|
73830095|NCT03183908|147207049|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.3|||||TWO_SIDED|98.0|-3.0|2.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Headache||2.4|-3.0|
73830096|NCT03183908|147207049|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.8|||||TWO_SIDED|98.0|-1.7|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||5.4|-1.7|
73830097|NCT03183908|147207049|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-3.3|4.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||4.4|-3.3|
73830098|NCT03183908|147207049|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.8|||||TWO_SIDED|98.0|-3.1|1.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Nausea||1.6|-3.1|
73830099|NCT03183908|147207049|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.0|||||TWO_SIDED|98.0|-1.8|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Vomiting||1.8|-1.8|
73830100|NCT03183908|147207050|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|2.3|||||TWO_SIDED|95.0|-1.1|5.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||5.8|-1.1|
73830101|NCT03183908|147207050|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.0|2.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Chills/Shivering||2.0|-3.0|
73830102|NCT03183908|147207050|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.5|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||1.8|-3.5|
73830103|NCT03183908|147207050|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|2.9|||||TWO_SIDED|95.0|-1.1|7.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||7.0|-1.1|
73830104|NCT03183908|147207050|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.0|-0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||-0.4|-3.0|
73830105|NCT03183908|147207050|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.2|2.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Headache||2.4|-3.2|
73830106|NCT03183908|147207050|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.5|4.5|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||4.5|-2.5|
73830107|NCT03183908|147207050|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.1|4.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||4.3|-3.1|
73830108|NCT03183908|147207050|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.3|1.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Nausea||1.3|-3.3|
73830109|NCT03183908|147207050|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.8|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Vomiting||1.8|-1.8|
73830110|NCT03183908|147207051|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.05|||||TWO_SIDED|95.0|-7.2|6.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||6.4|-7.2|
73830111|NCT03183908|147207051|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.1|-0.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||-0.6|-8.1|
73830112|NCT03183908|147207051|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|3.7|||||TWO_SIDED|95.0|-3.6|10.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||10.9|-3.6|
73830113|NCT03183908|147207051|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.4|6.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||6.6|-2.4|
73830114|NCT03183908|147207051|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|5.0|||||TWO_SIDED|95.0|2.0|12.2|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||12.2|2.0|
73830115|NCT03183908|147207051|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.3|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||7.3|-7.3|
73830116|NCT03183908|147207052|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5862|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes for Day 1 to Day 3 Group Comparisons||||0.5862
73830117|NCT03183908|147207052|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5648|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.5648
73830118|NCT03183908|147207052|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.4196|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes from Day 1 to Day 3 Group Comparisons||||0.4196
73830119|NCT03183908|147207052|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.2418|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes from Day 1 to Day 3 Group Comparisons||||0.2418
73830120|NCT03183908|147207052|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.0746|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes for Day 1 to Day 3 Group Comparisons||||0.0746
73830121|NCT03183908|147207052|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5497|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons||||0.5497
73830122|NCT03183908|147207053|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.6278|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes for Day 1 to Day 3 Group Comparisons||||0.6278
73830123|NCT03183908|147207053|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.5622|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.5622
73830124|NCT03183908|147207053|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.5538|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes for Day 1 to Day 3 Group Comparisons||||0.5538
73830125|NCT03183908|147207053|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.231|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes from Day 1 to Day 3 Group Comparisons||||0.2310
73830126|NCT03183908|147207053|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.0435|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes from Day 1 to Day 3 Group Comparisons||||0.0435
73830127|NCT03183908|147207053|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.6519|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes from Day 1 to Day 3 Group Comparisons||||0.6519
73830128|NCT03183908|147207054|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7483|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes from Day 1 to Day 3 Group Comparisons||||0.7483
73830129|NCT03183908|147207054|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7483|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.7483
73830130|NCT03183908|147207054|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4953|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes for Day 1 to Day 3 Group Comparisons||||0.4953
73830131|NCT03183908|147207054|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.8669|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes for Day 1 to Day 3 Group Comparisons||||0.8669
73830132|NCT03183908|147207054|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.8451|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes for Day 1 to Day 3 Group Comparisons||||0.8451
73830133|NCT03183908|147207054|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7376|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons||||0.7376
73830134|NCT03183908|147207055|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.7407|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes for Day 1 to Day 3 Group Comparisons||||0.7407
73830135|NCT03183908|147207056|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4032|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes for Day 1 to Day 3 Group Comparisons||||0.4032
73830136|NCT03183908|147207057|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4079|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes from Day 1 to Day 3 Group Comparisons||||0.4079
73830137|NCT03183908|147207058|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.7948|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes for Day 1 to Day 3 Group Comparisons||||0.7948
73830138|NCT03183908|147207059|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. Alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7953|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes from Day 1 to Day 3 Group Comparisons||||0.7953
73830139|NCT03183908|147207060|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.9329|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes from Day 1 to Day 3 Group Comparisons||||0.9329
73830140|NCT01499511|147207131|SUPERIORITY|||||||0.624|||||||ANOVA|||||||0.624
73830141|NCT01499511|147207132|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
73830142|NCT01499511|147207133|SUPERIORITY|||||||0.304|||||||ANOVA|||||||0.304
73830143|NCT01499511|147207134|SUPERIORITY|||||||0.641|||||||ANOVA|||||||0.641
73830144|NCT01499511|147207135|SUPERIORITY|||||||0.915|||||||ANOVA|||||||0.915
73830145|NCT01107015|147207161|OTHER|Sample size was determined on the basis of the primary outcome, change in glycated hemoglobin. The comparison of UC, which included 56 patients from nine practices, to CPDS, which included 62 patients from seven practices, had 80% power to detect a difference in mean glycated hemoglobin changes of 0.65 SD, corresponding to 1.0% if SD was 1.58%, using a two-sided test with 0.05 type I error after accounting for a within cluster correlation of 0.10.||||||0.027||||||CO (P = 0.027) and CPP (0.40) mean HbA1c levels decreased over 12 months.|Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin. Secondary analyses jointly compared 3-, 6-, 9-, and 12-month changes between groups. Random effects accounted for within-practice clustering and within-patient correlation.||||0.027
73830146|NCT01107015|147207161|SUPERIORITY||Mean Difference (Net)|0.05||||0.001|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin.||||0.001
73830147|NCT02054156|147207177|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0043|TWO_SIDED|95.0|0.37|0.83|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (\>=6 months - 3 years, \>3 - 6 years, \>6 - 12 years, and \>12 - 18 years).|||0.83|0.37|0.0043
73830148|NCT02054156|147207178|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9915|TWO_SIDED|95.0|0.64|1.55|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (\>=6 months - 3 years, \>3 - 6 years, \>6 - 12 years, and \>12 - 18 years).|||1.55|0.64|0.9915
73830149|NCT02054156|147207179|SUPERIORITY||Difference in % of Participants with SAE|-2.5||||0.7531|TWO_SIDED|95.0|-13.7|8.7|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.|||8.7|-13.7|0.7531
73830150|NCT02054156|147207179|SUPERIORITY||Difference in % of Participants with AE|4.4||||0.3593|TWO_SIDED|95.0|-3.5|12.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson.|||12.6|-3.5|0.3593
73830151|NCT02054156|147207180|SUPERIORITY||Rate Ratio|0.86||||0.0004|TWO_SIDED|95.0|0.8|0.94|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.||0.94|0.80|0.0004
73830152|NCT02054156|147207180|SUPERIORITY||Rate Ratio|1.25||||0.2098|TWO_SIDED|95.0|0.88|1.78|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.||1.78|0.88|0.2098
73830153|NCT01928849|147207181|OTHER||Odds Ratio (OR)|0.77||||0.53|TWO_SIDED|95.0|0.34|1.74|||Regression, Logistic|Univariable Logistic regression||||1.74|0.34|0.53
73830154|NCT01928849|147207182|OTHER|||||||0.95|||||||Chi-squared|||Comparison of rate of residual limb pain between treatment groups||||0.95
73830155|NCT01928849|147207182|OTHER|||||||0.74|||||||Chi-squared|||Comparison of rate of Phantom limb pain between treatment groups||||0.74
73830156|NCT01928849|147207183|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 0-24||||0.27
73830157|NCT01928849|147207183|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 24-48||||0.27
73830158|NCT01928849|147207184|OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI average pain score||||0.59
73830159|NCT01928849|147207184|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI Interference question sum||||0.16
73830160|NCT01928849|147207185|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
73830161|NCT01928849|147207186|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS numeric pain score||||0.42
73830162|NCT01928849|147207186|OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS supplemental question sum||||0.19
73830163|NCT01928849|147207187|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 0-24||||0.27
73830164|NCT01928849|147207187|OTHER|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 24-48||||0.26
73830165|NCT00297167|147207190|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-25.52|||<|0.001|TWO_SIDED|95.0|-31.73|-19.32|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA) model which included main effects for treatment and sequence and participant nested in sequence as a random effect.||-19.32|-31.73|<0.001
73830166|NCT00297167|147207191|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|||<|0.001|TWO_SIDED|95.0|-26.85|-16.14|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA)model which included main effects for treatment and sequence and participant nested in sequence as a random effect.||-16.14|-26.85|<0.001
73830167|NCT03185208|147207202|SUPERIORITY||treatment x time interaction coefficient|0.69||||0.048|TWO_SIDED||||||Mixed Models Analysis|||||||0.048
73830168|NCT03185208|147207203|SUPERIORITY||treatment x time interaction coefficient|-0.08835||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
73830169|NCT03185208|147207204|SUPERIORITY||treatment x time interaction coefficient|0.08738||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
73830170|NCT03185208|147207206|SUPERIORITY||treatment x time interaction coefficient|0.012||||0.93|TWO_SIDED||||||Mixed Models Analysis|||||||0.93
73830171|NCT03185208|147207207|SUPERIORITY||treatment x time interaction coefficient|-351.8||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
73830172|NCT03185208|147207208|SUPERIORITY||treatment x time interaction coefficient|58.95||||0.087|TWO_SIDED||||||Mixed Models Analysis|||||||0.087
73830173|NCT01186770|147207232|SUPERIORITY||Least square (LS) mean difference|2.83||||0.1692||95.0|-1.21|6.86||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with treatment as effect and analysis region as covariate.||6.86|-1.21|0.1692
73830174|NCT01186770|147207232|SUPERIORITY||LS mean difference|6.51||||0.0016|TWO_SIDED|95.0|2.47|10.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.||10.55|2.47|0.0016
73830175|NCT01186770|147207232|SUPERIORITY||LS mean difference|9.13|||<|0.0001|TWO_SIDED|95.0|5.09|13.18||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.||13.18|5.09|< 0.0001
73830176|NCT01186770|147207233|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3076|TWO_SIDED|95.0|0.82|1.84||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||1.84|0.82|0.3076
73830177|NCT01186770|147207233|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0339|TWO_SIDED|95.0|1.03|2.29||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||2.29|1.03|0.0339
73830178|NCT01186770|147207233|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0043||95.0|1.2|2.66||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||2.66|1.20|0.0043
73830179|NCT01186770|147207234|SUPERIORITY||LS mean difference|0.09||||0.692|TWO_SIDED|95.0|-0.36|0.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.55|-0.36|0.6920
73830180|NCT01186770|147207234|SUPERIORITY||LS mean difference|0.51||||0.0274|TWO_SIDED|95.0|0.06|0.97||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.97|0.06|0.0274
73830181|NCT01186770|147207234|SUPERIORITY||LS mean difference|0.53||||0.0237|TWO_SIDED|95.0|0.07|0.98||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.98|0.07|0.0237
73830182|NCT01129128|147207279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-173.0||||0.87|TWO_SIDED|95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of 0.9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml||||0.87
73830183|NCT01129128|147207279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|705.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of .9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml||||0.82
73830184|NCT01129128|147207280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15793.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values||||||0.82
73830185|NCT01129128|147207280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23472.0||||0.68||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values||||||0.68
73830186|NCT01129128|147207281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.0||||0.9||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values||||||0.90
73830187|NCT01129128|147207281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0||||0.76||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values||||||0.76
73830188|NCT01129128|147207282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.98||95.0|||||Regression, Linear|controlled for baseline levels||||||0.98
73830189|NCT01129128|147207282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.0||||0.34||95.0|||||Regression, Linear|controlled for baseline levels||||||0.34
73830190|NCT00961415|147207284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.37|0.69|||Log Rank|||||0.69|0.37|<0.001
73830191|NCT00961415|147207285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.23|TWO_SIDED|95.0|0.47|1.2|||Log Rank|||||1.20|0.47|0.230
73830192|NCT00961415|147207287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.006|TWO_SIDED|95.0|0.34|0.84|||Log Rank|||||0.84|0.34|0.006
73830193|NCT00961415|147207288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.38|0.7|||Log Rank|||||0.70|0.38|<0.001
73830194|NCT04497883|147207292|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|110.41|||||TWO_SIDED|90.0|91.7|132.94|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||132.94|91.70|
73830195|NCT04497883|147207293|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|122.49|||||TWO_SIDED|90.0|96.83|154.95|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||154.95|96.83|
73830196|NCT04497883|147207294|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|125.08|||||TWO_SIDED|90.0|97.99|159.64|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||159.64|97.99|
73830197|NCT00914069|147207303|SUPERIORITY_OR_OTHER|||||||0.05||||||Threshold for significance was p less than or equal to 0.05 by a one-tailed Fisher Exact Test.|Fisher Exact|||||||0.05
73830198|NCT00914069|147207306|SUPERIORITY_OR_OTHER|||||||0.8|||||||Fisher Exact|||||||0.8
73830199|NCT01933594|147207313|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
73830200|NCT01933594|147207314|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.94
73830201|NCT01933594|147207314|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.74
73830202|NCT01933594|147207314|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.18
73830203|NCT01933594|147207314|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.16
73830204|NCT01933594|147207315|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
73830205|NCT01933594|147207316|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.9
73830206|NCT01933594|147207316|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.07
73830207|NCT01933594|147207316|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.88
73830208|NCT01933594|147207316|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.92
73830209|NCT01933594|147207317|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 6 hours post infusion||||0.44
73830210|NCT01933594|147207317|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 12 hours post infusion||||0.024
73830211|NCT01933594|147207317|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.37
73830212|NCT01933594|147207317|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion||||0.79
73830213|NCT01933594|147207317|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.34
73830214|NCT01933594|147207318|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
73830215|NCT01933594|147207319|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
73830216|NCT01933594|147207320|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
73830217|NCT01933594|147207322|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.19
73830218|NCT01933594|147207322|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.63
73830219|NCT01933594|147207322|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.94
73830220|NCT01933594|147207322|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.66
73830221|NCT01933594|147207322|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.17
73830222|NCT01933594|147207323|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion||||0.73
73830223|NCT01933594|147207323|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion||||0.9
73830224|NCT01933594|147207324|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.8
73830225|NCT01933594|147207324|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.73
73830226|NCT01933594|147207324|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.84
73830227|NCT01933594|147207324|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.88
73830228|NCT01933594|147207324|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.64
73830229|NCT01933594|147207332|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.34
73830230|NCT01933594|147207332|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.004
73830231|NCT01933594|147207332|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.022
73830232|NCT01933594|147207332|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.008
73830233|NCT01933594|147207332|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 2 weeks post infusion 4||||0.55
73830234|NCT01933594|147207332|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 5 weeks post infusion 4||||0.48
73830235|NCT01933594|147207332|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.54
73830236|NCT01933594|147207332|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 18 weeks post infusion 4||||0.47
73830237|NCT01933594|147207334|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.95
73830238|NCT01933594|147207334|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.07
73830239|NCT01933594|147207334|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.26
73830240|NCT01933594|147207335|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.89
73830241|NCT01933594|147207335|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.14
73830242|NCT01933594|147207335|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.74
73830243|NCT01933594|147207336|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.71
73830244|NCT01933594|147207336|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.79
73830245|NCT01933594|147207336|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.38
73830246|NCT01933594|147207337|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||1
73830247|NCT01933594|147207337|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.92
73830248|NCT01933594|147207337|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.66
73830249|NCT01933594|147207338|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||1
73830250|NCT01933594|147207338|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.9
73830251|NCT01933594|147207338|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.47
73830252|NCT01933594|147207339|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.63
73830253|NCT01933594|147207339|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||hange from baseline to 24 hours post infusion 4||||0.51
73830254|NCT01933594|147207339|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.028
73830255|NCT01933594|147207340|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.62
73830256|NCT01933594|147207340|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.15
73830257|NCT01933594|147207340|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.69
73830258|NCT01933594|147207341|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.28
73830259|NCT01933594|147207341|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.15
73830260|NCT01933594|147207341|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.81
73830261|NCT01933594|147207342|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.13
73830262|NCT01933594|147207342|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.22
73830263|NCT01933594|147207342|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.031
73830264|NCT01933594|147207343|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.13
73830265|NCT01933594|147207343|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.39
73830266|NCT01933594|147207343|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.12
73830267|NCT01933594|147207344|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.7
73830268|NCT01933594|147207344|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.51
73830269|NCT01933594|147207344|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.94
73830270|NCT01933594|147207345|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.78
73830271|NCT01933594|147207345|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.41
73830272|NCT01933594|147207345|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.94
73830273|NCT01933594|147207346|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD4||||0.69
73830274|NCT01933594|147207346|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD4||||0.27
73830275|NCT01933594|147207347|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD8||||0.81
73830276|NCT01933594|147207347|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD8||||0.81
73830277|NCT01933594|147207348|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.37
73830278|NCT01933594|147207348|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.1
73830279|NCT01933594|147207348|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.28
73830280|NCT01933594|147207348|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.16
73830281|NCT01933594|147207348|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.12
73830282|NCT01933594|147207349|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.027
73830283|NCT01933594|147207349|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.004
73830284|NCT01933594|147207349|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.1
73830285|NCT01933594|147207349|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.022
73830286|NCT01933594|147207349|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.17
73830287|NCT05722015|147207358|NON_INFERIORITY|Non-inferiority margin is 0.8.|Geometric Mean Ratio (GMR)|1.14|||<|1e-05|TWO_SIDED|96.0|1.06|1.22|||Welch's t test|One-sided p-value was calculated using the Welch's t test.|GMR was calculated as the ratio of geometric mean (GM) of Cycle 1 AUC0-6 weeks in Arm 1 to that of Arm 2. The associated 96% confidence interval (CI) were calculated using Welch's t test.|||1.22|1.06|<0.00001
73830288|NCT05722015|147207359|NON_INFERIORITY|Non-inferiority margin is 0.8.|GMR|1.67|||<|1e-05|TWO_SIDED|94.0|1.52|1.84|||Welch's t test|One sided p-value was calculated using Welch's t test.|GMR was calculated as the ratio of GM of Cycle 3 Ctrough in Arm 1 to that of Arm 2. The associated 94% CI were calculated using Welch's t test.|||1.84|1.52|<0.00001
73830289|NCT04513366|147207374|SUPERIORITY||Risk Difference (RD)|0.44|||<|0.0001|TWO_SIDED|97.5|0.23|0.64|||Mantel Haenszel|||||0.64|0.23|<.0001
73830290|NCT04513366|147207374|SUPERIORITY||Risk Difference (RD)|0.53|||<|0.0001|TWO_SIDED|97.5|0.32|0.73|||Mantel Haenszel|||||0.73|0.32|<.0001
73830291|NCT04513366|147207375|SUPERIORITY||Least Square (LS) Mean Difference|-5.3|||<|0.001|TWO_SIDED|97.5|-7.18|-3.42|||ANCOVA|||||-3.42|-7.18|<.001
73830292|NCT04513366|147207375|SUPERIORITY||LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|97.5|-7.57|-3.7|||ANCOVA|||||-3.70|-7.57|<.001
73830293|NCT04513366|147207376|SUPERIORITY||LS Mean Difference|-64.3|||<|0.001|TWO_SIDED|97.5|-87.85|-40.85|||ANCOVA|||||-40.85|-87.85|<.001
73830294|NCT04513366|147207376|SUPERIORITY||LS Mean Difference|-69.8|||<|0.001|TWO_SIDED|97.5|-92.16|-47.35|||ANCOVA|||||-47.35|-92.16|<.001
73830295|NCT04513366|147207377|SUPERIORITY||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|2.6||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.090
73830296|NCT04513366|147207377|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.5||0.472|TWO_SIDED||||||Mixed Models Analysis|||||||0.472
73830297|NCT04513366|147207378|SUPERIORITY||Difference|0.58||||0.0003|TWO_SIDED|97.5|0.25|0.91|||Chi-squared|||||0.91|0.25|0.0003
73830298|NCT04513366|147207378|SUPERIORITY||Difference|0.25||||0.1895|TWO_SIDED|97.5|-0.36|0.86|||Chi-squared|||||0.86|-0.36|0.1895
73830299|NCT04513366|147207379|SUPERIORITY||Difference|0.43||||0.0035|TWO_SIDED|97.5|0.14|0.72|||Chi-squared|||||0.72|0.14|0.0035
73830300|NCT04513366|147207379|SUPERIORITY||Difference|0.28||||0.0428|TWO_SIDED|97.5|-0.02|0.57|||Chi-squared|||||0.57|-0.02|0.0428
73830301|NCT04513366|147207380|SUPERIORITY||LS Mean Difference|-0.2||||0.517|TWO_SIDED|97.5|-1.1|0.61|||Mixed Models Analysis|||||0.61|-1.10|0.517
73830302|NCT04513366|147207380|SUPERIORITY||LS Mean Difference|0.4||||0.23|TWO_SIDED|97.5|-0.39|1.28|||Mixed Models Analysis|||||1.28|-0.39|0.230
73830303|NCT04513366|147207381|SUPERIORITY||LS Mean Difference|-0.1||||0.25|TWO_SIDED|97.5|-0.35|0.12|||Mixed Models Analysis|||||0.12|-0.35|0.250
73830304|NCT04513366|147207381|SUPERIORITY||LS Mean Difference|0.1||||0.506|TWO_SIDED|97.5|-0.16|0.29|||Mixed Models Analysis|||||0.29|-0.16|0.506
73830305|NCT04513366|147207382|SUPERIORITY||LS Mean Difference|-0.1||||0.653|TWO_SIDED|97.5|-0.55|0.37|||ANOVA|||||0.37|-0.55|0.653
73830306|NCT04513366|147207382|SUPERIORITY||LS Mean Difference|0.1||||0.629|TWO_SIDED|97.5|-0.36|0.56|||ANOVA|||||0.56|-0.36|0.629
73830307|NCT04513366|147207383|SUPERIORITY||LS Mean Difference|0.1||||0.731|TWO_SIDED|97.5|-0.4|0.54|||ANOVA|||Treatment Periods 1-3 (Months 1-3)||0.54|-0.40|0.731
73830308|NCT04513366|147207383|SUPERIORITY||LS Mean Difference|0.1||||0.583|TWO_SIDED|97.5|-0.35|0.58|||ANOVA|||Treatment Periods 1-3 (Month 1-3)||0.58|-0.35|0.583
73830309|NCT04478266|147207391|SUPERIORITY||Hazard Ratio (HR)|1.209||||0.9304|TWO_SIDED|95.0|0.939|1.557||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025 level.|Stratified Log-Rank test|Stratified on presence of De-novo metastatic disease, Postmenopausal women and Visceral metastasis according to IRT.|Letrozole + Palbociclib versus Amcenestrant + Palbociclib|A hierarchical testing procedure was used to ensure a strong control of the overall Type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at one-sided 2.5% for the primary and the first secondary outcome.||1.557|0.939|0.9304
73830310|NCT04058717|147207408|OTHER||H-statistic|10.23||||0.017|TWO_SIDED||||||Kruskal-Wallis|||||||0.017
73830311|NCT04058717|147207409|OTHER||H-statistic|7.57||||0.056|TWO_SIDED||||||Kruskal-Wallis|||||||0.056
73830312|NCT04058717|147207410|OTHER||H-statistic|1.26||||0.74|TWO_SIDED||||||Kruskal-Wallis|||||||0.74
73830313|NCT04058717|147207411|OTHER||Slope|4.13||||0.248|TWO_SIDED||||||Kruskal-Wallis|||||||0.248
73830314|NCT04058717|147207412|OTHER||H-statistic|9.33||||0.025|TWO_SIDED||||||Kruskal-Wallis|||||||0.025
73830315|NCT04058717|147207413|OTHER|||||||0.289|||||||Fisher Exact|||||||0.289
73830316|NCT03074500|147207424|SUPERIORITY|||||||0.643|||||||Kruskal-Wallis|||Comparison of baseline values||||0.643
73830317|NCT03074500|147207424|SUPERIORITY|||||||0.018|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.018
73830318|NCT03074500|147207424|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Comparison of 4 week After Treatment Values||||0.027
73830319|NCT03074500|147207424|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.677
73830320|NCT03074500|147207424|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.677
73830321|NCT03074500|147207424|SUPERIORITY|||||||0.326||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.326
73830322|NCT03074500|147207424|SUPERIORITY|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.019
73830323|NCT03074500|147207424|SUPERIORITY|||||||0.014||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.014
73830324|NCT03074500|147207424|SUPERIORITY|||||||0.427||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.427
73830325|NCT03074500|147207424|SUPERIORITY|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.023
73830326|NCT03074500|147207424|SUPERIORITY|||||||0.021||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.021
73830327|NCT03074500|147207424|SUPERIORITY|||||||0.545||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Value||||0.545
73830328|NCT03074500|147207424|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
73830329|NCT03074500|147207424|SUPERIORITY|||||||0.67|||||||Friedman's two-way analysis of variance|||||||0.670
73830330|NCT03074500|147207424|SUPERIORITY|||||||0.192|||||||Friedman's two-way analysis of variance|||||||0.192
73830331|NCT03074500|147207425|SUPERIORITY|||||||0.633|||||||Kruskal-Wallis|||Comparison of Before Treatment Values||||0.633
73830332|NCT03074500|147207425|SUPERIORITY|||||||0.282|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.282
73830333|NCT03074500|147207425|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.015
73830334|NCT03074500|147207425|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.677
73830335|NCT03074500|147207425|SUPERIORITY|||||||0.344||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.344
73830336|NCT03074500|147207425|SUPERIORITY|||||||0.596||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.596
73830337|NCT03074500|147207425|SUPERIORITY|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.161
73830338|NCT03074500|147207425|SUPERIORITY|||||||0.257||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.257
73830339|NCT03074500|147207425|SUPERIORITY|||||||0.449||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.449
73830340|NCT03074500|147207425|SUPERIORITY|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.013
73830341|NCT03074500|147207425|SUPERIORITY|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.019
73830342|NCT03074500|147207425|SUPERIORITY|||||||0.325||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.325
73830343|NCT03074500|147207425|SUPERIORITY|||||||0.003|||||||Friedman's two-way analysis of variance|||||||0.003
73830344|NCT03074500|147207425|SUPERIORITY|||||||0.323|||||||Friedman's two-way analysis of variance|||||||0.323
73830345|NCT03074500|147207425|SUPERIORITY|||||||0.641|||||||Friedman's two-way analysis of variance|||||||0.641
73830346|NCT03074500|147207426|SUPERIORITY|||||||0.715|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.715
73830347|NCT03074500|147207426|SUPERIORITY|||||||0.227|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.227
73830348|NCT03074500|147207426|SUPERIORITY|||||||0.012|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.012
73830349|NCT03074500|147207426|SUPERIORITY|||||||0.907||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.907
73830350|NCT03074500|147207426|SUPERIORITY|||||||0.482||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.482
73830351|NCT03074500|147207426|SUPERIORITY|||||||0.485||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.485
73830352|NCT03074500|147207426|SUPERIORITY|||||||0.129||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.129
73830353|NCT03074500|147207426|SUPERIORITY|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.12
73830354|NCT03074500|147207426|SUPERIORITY|||||||0.935||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.935
73830355|NCT03074500|147207426|SUPERIORITY|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.002
73830356|NCT03074500|147207426|SUPERIORITY|||||||0.036||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.036
73830357|NCT03074500|147207426|SUPERIORITY|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.056
73830358|NCT03074500|147207426|SUPERIORITY|||||||0.016|||||||Friedman's two-way analysis of variance|||||||0.016
73830359|NCT03074500|147207426|SUPERIORITY|||||||0.618|||||||Friedman's two-way analysis of variance|||||||0.618
73830360|NCT03074500|147207426|SUPERIORITY|||||||0.48|||||||Friedman's two-way analysis of variance|||||||0.48
73830361|NCT03074500|147207426|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.034
73830362|NCT03074500|147207426|SUPERIORITY|||||||0.041|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.041
73830363|NCT03074500|147207426|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||1
73830364|NCT03074500|147207427|SUPERIORITY|||||||0.103|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.103
73830365|NCT03074500|147207427|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.002
73830366|NCT03074500|147207427|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.008
73830367|NCT03074500|147207427|SUPERIORITY|||||||0.76||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.76
73830368|NCT03074500|147207427|SUPERIORITY|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||1
73830369|NCT03074500|147207427|SUPERIORITY|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.056
73830370|NCT03074500|147207427|SUPERIORITY|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.002
73830371|NCT03074500|147207427|SUPERIORITY|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.12
73830372|NCT03074500|147207427|SUPERIORITY|||||||0.117||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.117
73830373|NCT03074500|147207427|SUPERIORITY|||||||0.006||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.006
73830374|NCT03074500|147207427|SUPERIORITY|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.013
73830375|NCT03074500|147207427|SUPERIORITY|||||||0.487||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.487
73830376|NCT03074500|147207427|SUPERIORITY|||||||0.002|||||||Friedman's two-way analysis of variance|||||||0.002
73830377|NCT03074500|147207427|SUPERIORITY|||||||0.102|||||||Friedman's two-way analysis of variance|||||||0.102
73830378|NCT03074500|147207427|SUPERIORITY|||||||0.165|||||||Friedman's two-way analysis of variance|||||||0.165
73830379|NCT03074500|147207427|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.007
73830380|NCT03074500|147207427|SUPERIORITY|||||||0.028|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.028
73830381|NCT03074500|147207427|SUPERIORITY|||||||0.83|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.83
73830382|NCT03074500|147207428|SUPERIORITY|||||||0.837|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.837
73830383|NCT03074500|147207428|SUPERIORITY|||||||0.215|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.215
73830384|NCT03074500|147207428|SUPERIORITY|||||||0.078|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.078
73830385|NCT03074500|147207428|SUPERIORITY|||||||0.699||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.699
73830386|NCT03074500|147207428|SUPERIORITY|||||||0.846||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.846
73830387|NCT03074500|147207428|SUPERIORITY|||||||0.56||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.56
73830388|NCT03074500|147207428|SUPERIORITY|||||||0.087||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.087
73830389|NCT03074500|147207428|SUPERIORITY|||||||0.183||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.183
73830390|NCT03074500|147207428|SUPERIORITY|||||||0.719||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.719
73830391|NCT03074500|147207428|SUPERIORITY|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.023
73830392|NCT03074500|147207428|SUPERIORITY|||||||0.196||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.196
73830393|NCT03074500|147207428|SUPERIORITY|||||||0.318||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.318
73830394|NCT03074500|147207428|SUPERIORITY|||||||0.001|||||||Friedman's two-way analysis of variance|||||||0.001
73830395|NCT03074500|147207428|SUPERIORITY|||||||0.483|||||||Friedman's two-way analysis of variance|||||||0.483
73830396|NCT03074500|147207428|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
73830397|NCT03074500|147207429|SUPERIORITY|||||||0.897|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.897
73830398|NCT03074500|147207429|SUPERIORITY|||||||0.325|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.325
73830399|NCT03074500|147207429|SUPERIORITY|||||||0.172|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.172
73830400|NCT03074500|147207429|SUPERIORITY|||||||0.622||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.622
73830401|NCT03074500|147207429|SUPERIORITY|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.909
73830402|NCT03074500|147207429|SUPERIORITY|||||||0.79||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.79
73830403|NCT03074500|147207429|SUPERIORITY|||||||0.24||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.24
73830404|NCT03074500|147207429|SUPERIORITY|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.161
73830405|NCT03074500|147207429|SUPERIORITY|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.909
73830406|NCT03074500|147207429|SUPERIORITY|||||||0.255||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.255
73830407|NCT03074500|147207429|SUPERIORITY|||||||0.058||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.058
73830408|NCT03074500|147207429|SUPERIORITY|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.569
73830409|NCT03074500|147207429|SUPERIORITY|||||||0.007|||||||Friedman's two-way analysis of variance|||||||0.007
73830410|NCT03074500|147207429|SUPERIORITY|||||||0.614|||||||Friedman's two-way analysis of variance|||||||0.614
73830411|NCT03074500|147207429|SUPERIORITY|||||||0.072|||||||Friedman's two-way analysis of variance|||||||0.072
73830412|NCT03074500|147207429|SUPERIORITY|||||||0.447|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.447
73830413|NCT03074500|147207429|SUPERIORITY|||||||0.084|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.084
73830414|NCT03074500|147207429|SUPERIORITY|||||||0.235|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.235
73830415|NCT03074500|147207430|SUPERIORITY|||||||0.958|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.958
73830416|NCT03074500|147207430|SUPERIORITY|||||||0.597|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.597
73830417|NCT03074500|147207430|SUPERIORITY|||||||0.518|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.518
73830418|NCT03074500|147207430|SUPERIORITY|||||||0.88||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.88
73830419|NCT03074500|147207430|SUPERIORITY|||||||0.733||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.733
73830420|NCT03074500|147207430|SUPERIORITY|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||1
73830421|NCT03074500|147207430|SUPERIORITY|||||||0.404||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.404
73830422|NCT03074500|147207430|SUPERIORITY|||||||0.97||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.97
73830423|NCT03074500|147207430|SUPERIORITY|||||||0.362||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.362
73830424|NCT03074500|147207430|SUPERIORITY|||||||0.271||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.271
73830425|NCT03074500|147207430|SUPERIORITY|||||||0.519||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.519
73830426|NCT03074500|147207430|SUPERIORITY|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.569
73830427|NCT03074500|147207430|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
73830428|NCT03074500|147207430|SUPERIORITY|||||||0.973|||||||Friedman's two-way analysis of variance|||||||0.973
73830429|NCT03074500|147207430|SUPERIORITY|||||||0.886|||||||Friedman's two-way analysis of variance|||||||0.886
73830430|NCT03074500|147207430|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.82
73830431|NCT03074500|147207430|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.017
73830432|NCT03074500|147207430|SUPERIORITY|||||||0.734|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.734
73830433|NCT03114150|147207431|SUPERIORITY||Slope|-0.02|||<|0.05|TWO_SIDED|95.0|-0.04|0.01|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom|Parameter is the interaction term for the interaction of group, learning rate, and session.|We tested the prediction that learning rate would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, according to our statistical analysis plan.||.01|-.04|<.05
73830434|NCT03114150|147207432|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom|Parameter is the interaction term for the interaction of exercise condition (intensity) and session.|We tested the prediction that hippocampal-cortical functional connectivity would change more for the moderate-to-vigorous acute condition compared to the light intensity condition. This prediction was tested with a linear mixed model, according to our statistical analysis plan.||.02|-.01|<.05
73830435|NCT03114150|147207433|SUPERIORITY||Mean Difference (Net)|0.0|||<|0.05|TWO_SIDED|95.0|-0.03|0.02|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom||We tested the prediction that functional connectivity strength would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, according to our statistical analysis plan.|Parameter is the interaction term for the interaction of group and session.|.02|-.03|<.05
73830436|NCT03114150|147207434|SUPERIORITY||Mean Difference (Final Values)|1.42|||<|0.05|TWO_SIDED|95.0|0.27|2.59|||Mixed Models Analysis|Residualized change model, as reported in our protocol paper.||We tested the prediction that cardiorespiratory fitness would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, as reported in our protocol paper.||2.59|.27|<.05
73830437|NCT00362232|147207435|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.71|||<|0.001||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the primary efficacy endpoint in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||-0.17|-5.25|<0.001
73830438|NCT00362232|147207435|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.71||||0.036||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences||Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).||-0.17|-5.25|0.036
73830439|NCT00362232|147207436|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.19||||0.012||95.0|-5.67|-0.71|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).||-0.71|-5.67|0.012
73830440|NCT00362232|147207437|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.37||||0.456||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.6|-1.34|0.456
73830441|NCT00362232|147207437|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.37|||<|0.001||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.6|-1.34|<0.001
73830442|NCT00362232|147207438|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.8||||0.124||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.22|-1.82|0.124
73830443|NCT00362232|147207438|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.8|||<|0.001||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.22|-1.82|<0.001
73830444|NCT00362232|147207439|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.44||||||95.0|-1.59|0.66|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.66|-1.59|
73830445|NCT00362232|147207440|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.72||||||95.0|-1.81|0.36|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.36|-1.81|
73830446|NCT00362232|147207441|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.38||||||95.0|-4.84|0.07|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.07|-4.84|
73830447|NCT00362232|147207442|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.67||||||95.0|-5.02|-0.32|||||Mantel-Haenszel weighted difference to Enoxaparin|||-0.32|-5.02|
73830448|NCT00362232|147207443|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.24||||||95.0|-0.22|0.71|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.71|-0.22|
73830449|NCT00362232|147207444|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11||||||95.0|-0.35|0.56||||||||0.56|-0.35|
73830450|NCT00362232|147207445|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3||||||95.0|-1.56|0.94|||||Exact methods for difference to Enoxaparin|||0.94|-1.56|
73830451|NCT00362232|147207446|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.47||||0.054||95.0|-4.99|0.04|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.04|-4.99|0.054
73830452|NCT00362232|147207446|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.47|||<|0.001||95.0|-4.49|0.04|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||0.04|-4.49|<0.001
73830453|NCT00362232|147207447|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.97||||0.017||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||-0.53|-5.42|0.017
73830454|NCT00362232|147207447|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.97|||<|0.001||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||-0.53|-5.42|<0.001
73830455|NCT00362232|147207448|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.57||||0.27||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.44|-1.57|0.270
73830456|NCT00362232|147207448|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.57|||<|0.001||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.44|-1.57|<0.001
73830457|NCT00362232|147207449|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.98||||0.074||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.10|-2.06|0.074
73830458|NCT00362232|147207449|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided) .|Risk Difference (RD)|-0.98|||<|0.001||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.10|-2.06|<0.001
73830459|NCT00362232|147207450|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.39||||0.11||95.0|-0.09|0.88|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.88|-0.09|0.110
73830460|NCT00090103|147207464|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.8||||0.18||95.0|0.58|1.11||Log-rank test with stratification by cluster.|Log Rank|||||1.11|0.58|0.18
73830461|NCT00090103|147207464|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.34|||<|0.001||95.0|0.26|0.45||Log-rank test with stratification by cluster.|Log Rank|||||0.45|0.26|<0.001
73830462|NCT00090103|147207466|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||Log rank test with stratification by cluster.|Log Rank|||||||0.18
73830463|NCT00090103|147207466|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Log rank test with stratification by cluster.|Log Rank|||||||<0.001
73830464|NCT00090103|147207468|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.65|||<|0.001||95.0|0.52|0.8|||Log Rank|Log-rank test with stratification by cluster.||||0.80|0.52|<0.001
73830465|NCT00090103|147207468|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.59|||<|0.001||95.0|0.48|0.72|||Log Rank|||||0.72|0.48|<0.001
73830466|NCT00090103|147207469|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.65
73830467|NCT00090103|147207469|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Log Rank|Mantel-Hanenszel test with stratification by cluster.||||||0.10
73830468|NCT00090103|147207470|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.95
73830469|NCT00090103|147207470|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.24
73830470|NCT03979313|147207495|SUPERIORITY||Relative Risk Reduction (RRR)|62.15||||0.0708|TWO_SIDED|95.0|-8.57|86.8|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||86.80|-8.57|0.0708
73830471|NCT03979313|147207496|SUPERIORITY||Relative Risk Reduction (RRR)|74.53|||<|0.0001|TWO_SIDED|95.0|49.63|87.12|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||87.12|49.63|<0.0001
73830472|NCT03979313|147207497|SUPERIORITY||Relative Risk Reduction (RRR)|76.36|||<|0.0001|TWO_SIDED|95.0|62.27|85.18|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||85.18|62.27|<0.0001
73830473|NCT03979313|147207498|SUPERIORITY||Relative Risk Reduction (RRR)|76.84||||0.0002|TWO_SIDED|95.0|49.36|89.41|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||89.41|49.36|0.0002
73830474|NCT00300053|147207502|SUPERIORITY|||||||0.02|||||||ANCOVA|||Frequency of angina episodes per week 6 months after treatment.||||0.020
73830475|NCT00300053|147207502|SUPERIORITY|||||||0.035|||||||ANCOVA|||Frequency of angina episodes per week 12 months after treatment.||||0.035
73830476|NCT00300053|147207502|SUPERIORITY|||||||0.167|||||||ANCOVA|||Frequency of angina episodes per week 6 months after treatment.||||0.167
73830477|NCT00300053|147207502|SUPERIORITY|||||||0.181|||||||ANCOVA|||Frequency of angina episodes per week 12 months after treatment.||||0.181
73830478|NCT00300053|147207503|SUPERIORITY|||||||0.014|||||||ANCOVA|||Change from baseline to 6 months||||0.014
73830479|NCT00300053|147207503|SUPERIORITY|||||||0.017|||||||ANCOVA|||Change from baseline to 12 months||||0.017
73830480|NCT00300053|147207503|SUPERIORITY|||||||0.097|||||||ANCOVA|||Change from baseline to 6 months||||0.097
73830481|NCT00300053|147207503|SUPERIORITY|||||||0.134|||||||ANCOVA|||Change from baseline to 12 months||||0.134
73830482|NCT04383132|147207526|OTHER|||||||0.388||||||Independent t-test was used to compare mean CIT between two groups. The statistical significance level was accepted as p\<0.05|t-test, 2 sided|||In sample size calculation, CIT and SD were used. It was found that 326 patients (163 per group) were required to detect a 60-second difference in CIT (SD 192 secs), with 80% power and two-sided alpha 0.05. The frequency of the auxiliary maneuvers was calculated that 324 patients were required for a 20% reduction in the auxiliary maneuvers. In case of becoming lost to follow up and withdrawal, the number of patients was expanded by 5%, and a total of 346 patients, were included in the study.||||0.388
73830483|NCT04383132|147207527|OTHER|||||||0.069||||||For the comparison of ancillary maneuvers Pearson chi-square test, Fisher's exact test, and Fisher-Freeman-Halton exact test were used.|Chi-squared|||||||0.069
73830484|NCT04383132|147207528|OTHER|||||||0.487||||||Independent t-test was used to compare mean CIL between two groups.|t-test, 2 sided|||||||0.487
73830485|NCT04383132|147207529|OTHER|||||||0.822|||||||Chi-squared|||||||0.822
73830486|NCT04383132|147207530|OTHER|||||||0.016|||||||Chi-squared|||||||0.016
73830487|NCT04383132|147207531|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
73830488|NCT04383132|147207532|OTHER|||||||0.184|||||||Fisher Exact|||||||0.184
73830489|NCT02469857|147207555|SUPERIORITY|||||||0.135|||||||Chi-squared|||This analysis utilized the mITT analysis population.||||0.135
73830490|NCT02469857|147207555|SUPERIORITY|||||||0.025|||||||Chi-squared|||This analysis utilized the US-mITT analysis population.||||0.025
73830491|NCT02469857|147207559|SUPERIORITY|||||||0.069|||||||Chi-squared|||||||0.069
73830492|NCT02469857|147207560|SUPERIORITY|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||||||0.401
73830493|NCT02469857|147207561|SUPERIORITY|||||||0.195|||||||Wilcoxon (Mann-Whitney)|||||||0.195
73830494|NCT02469857|147207562|SUPERIORITY|||||||0.596|||||||Wilcoxon (Mann-Whitney)|||||||0.596
73830495|NCT02469857|147207563|SUPERIORITY|||||||0.512|||||||Wilcoxon (Mann-Whitney)|||||||0.512
73830496|NCT02469857|147207564|SUPERIORITY|||||||0.033|||||||Chi-squared|||||||0.033
73830497|NCT02469857|147207565|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.554|TWO_SIDED|95.0|0.5|1.46|||Log Rank|||||1.46|0.50|0.554
73830498|NCT02469857|147207566|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.148|TWO_SIDED|95.0|0.23|1.26|||Log Rank|||||1.26|0.23|0.148
73830499|NCT02469857|147207567|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.736|TWO_SIDED|95.0|0.46|1.73|||Log Rank|||||1.73|0.46|0.736
73830500|NCT02469857|147207568|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.093|TWO_SIDED|95.0|0.09|1.25|||Log Rank|||||1.25|0.09|0.093
73830501|NCT02469857|147207569|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.352|TWO_SIDED|95.0|0.35|1.46|||Log Rank|||||1.46|0.35|0.352
73830502|NCT02469857|147207570|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.031|TWO_SIDED|95.0|0.04|0.99|||Log Rank|||||0.99|0.04|0.031
73830503|NCT02469857|147207571|SUPERIORITY|||||||0.024|||||||Chi-squared|||||||0.024
73830504|NCT02469857|147207572|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
73830505|NCT02469857|147207573|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||0.034
73830506|NCT02469857|147207574|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
73830507|NCT02110693|147207575|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||TWO_SIDED|95.0|0.64|0.75||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.75|.64|
73830508|NCT02110693|147207575|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.74|||||TWO_SIDED|95.0|0.68|0.79||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.79|.68|
73830509|NCT02110693|147207576|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.71|||||TWO_SIDED|95.0|0.63|0.79||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.79|.63|
73830510|NCT02110693|147207576|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||TWO_SIDED|95.0|0.62|0.77||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.77|.62|
73830511|NCT02110693|147207577|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.57|||||TWO_SIDED|95.0|0.47|0.67||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.67|.47|
73830512|NCT02110693|147207577|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.6|||||TWO_SIDED|95.0|0.5|0.69||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.69|.50|
73830513|NCT02110693|147207578|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|sensivity|0.66|||||TWO_SIDED|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.77|.53|
73830514|NCT02110693|147207578|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|Sensivity|0.66|||||TWO_SIDED|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.77|.53|
73830515|NCT02110693|147207582|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard AUDIT-C score was assessed using Spearman Correlation.|Spearman Correlation|0.63|||||TWO_SIDED|95.0|0.59|0.66|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.66|.59|
73830516|NCT02110693|147207582|OTHER|The association on the interviewer and tablet administered versions of the TAPS Tool compared to the reference standard of the AUDIT C score was assessed using Spearman Correlation.|Spearman Correlation|0.64|||||TWO_SIDED|95.0|0.61|0.68|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C Score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.68|.61|
73830517|NCT02110693|147207584|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard Smokeless Tobacco Questionnaire was assessed using Spearman Correlation.|Spearman Correlation|0.29|||||TWO_SIDED|95.0|0.25|0.33|||||The estimated value is a Spearman Correlation point estimate between the TAPS Tool Tobacco Score and the Smokeless Tobacco Questionnare. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet computer) was tested separately against the reference measure.||.33|.25|
73830518|NCT02110693|147207584|OTHER||Spearman Correlation|0.28|||||TWO_SIDED|95.0|0.24|0.32|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Tobacco Score and the score on the Smokeless Tobacco Questionnaire. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.32|.24|
73830519|NCT02110693|147207585|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard of the results of the oral fluid test was assessed using Spearman Correlation.|Spearman Correlation|0.42|||||TWO_SIDED|95.0|0.35|0.48|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Cannabis Score and the results of the Oral Fluid Test. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.48|.35|
73830520|NCT02110693|147207585|OTHER||Spearman Correlation|0.4|||||TWO_SIDED|95.0|0.33|0.46|||||The estimated value is a point estimate of the Spearman Correlation between the TAPS Tool Cannabis Score and the Oral Fluid Cannabis Screen. A Confidence Interval rather than a dispersion value is therefore reported.|||.46|.33|
73830521|NCT04810962|147207586|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73830522|NCT04810962|147207587|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73830523|NCT04810962|147207589|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73830524|NCT04810962|147207590|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73830525|NCT04810962|147207591|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73830526|NCT04810962|147207592|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73830527|NCT04810962|147207593|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73830528|NCT04810962|147207594|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73830529|NCT04810962|147207595|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73830530|NCT04810962|147207596|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73830531|NCT04810962|147207597|SUPERIORITY||Mean Difference (Net)|-1.2|||<|0.001|TWO_SIDED|95.0|-1.4|-1.0|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-1.0|-1.4|<0.001
73830532|NCT04810962|147207598|SUPERIORITY||Mean Difference (Net)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.3|-0.7|<0.001
73830533|NCT04810962|147207599|SUPERIORITY||Mean Difference (Net)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.3|-0.5|<0.001
73830534|NCT04810962|147207600|SUPERIORITY||Mean Difference (Net)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.02|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.02|-0.07|<0.001
73830535|NCT04810962|147207601|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.001|TWO_SIDED|95.0|-0.1|-0.05|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.05|-0.10|<0.001
73830536|NCT04810962|147207602|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.001|TWO_SIDED|95.0|-0.11|-0.05|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.05|-0.11|<0.001
73830537|NCT04810962|147207603|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73830538|NCT02701634|147207614|SUPERIORITY|||||||0.99||||||P-value was calculated using the stratified Cochran-Mantel-Haenszel Chi-square test.|Chi-squared|||||||0.99
73830539|NCT02701634|147207619|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
73830540|NCT02701634|147207620|SUPERIORITY|||||||0.33||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided|||||||0.33
73830541|NCT02701634|147207621|SUPERIORITY|||||||0.49||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided|||||||0.49
73830542|NCT02701634|147207622|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8|TWO_SIDED|95.0|0.55|2.18||P-value was calculated using the log-rank test and stratified for disease severity and usage of calcineurin inhibitor or mycophenolate mofetil (MMF).|Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for disease severity and usage of calcineurin inhibitor or MMF|||2.18|0.55|0.800
73830543|NCT01033136|147207631|EQUIVALENCE|To test if MCET is equivalent to CPT in decreasing PTSD symptoms, we test the equivalence of the proportion of patients whose CAPS scores decrease by 10 from baseline, by testing whether the difference in proportions between the 2 interventions ≤ to the equivalence margin δb of .20. Results are reported based on 3-month follow-up data.||||||0.3||||||The threshold for statistical significance is p \<.05 and is not adjusted for multiple comparisons.|Fisher Exact|||||||0.30
73830544|NCT01033136|147207632|OTHER|||||||0.68||||||The threshold for statistical significance is p \<.05 and is not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom: 2, 54||Longitudinal analysis of PDSS scores||||0.68
73830545|NCT00142415|147207635|OTHER|The maximum tolerated dose (MTD) was determined using a standard 3 + 3 dose-escalation design. The occurrence of DLTs was compared across cohorts.|Maximum tolerated dose (mCi/m^2)|65.0|||||TWO_SIDED|||||||||||||
73830546|NCT03416179|147207682|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6579|TWO_SIDED|95.0|0.755|1.532|||Log Rank|||Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio less than (\<) 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2 compared to Placebo + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2.||1.532|0.755|0.6579
73830547|NCT03416179|147207683|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5955|TWO_SIDED|95.0|0.775|1.388|||Log Rank|||Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO QD + Azacitidine compared to Placebo + Azacitidine||1.388|0.775|0.5955
73830548|NCT03416179|147207684|OTHER|||||||0.5095|||||||Mantel Haenszel|||||||0.5095
73830549|NCT03416179|147207685|OTHER|||||||0.8359|||||||Mantel Haenszel|||||||0.8359
73830550|NCT03609177|147207756|SUPERIORITY||Risk Difference (RD)|6.8|||<|0.05|TWO_SIDED|95.0|2.8|10.8|||binomial regression with identity link|||||10.8|2.8|<0.05
73830551|NCT03609177|147207757|SUPERIORITY||Risk Difference (RD)|-0.1|||<|0.05|TWO_SIDED|95.0|-0.7|0.6|||binomial regression with identity link|||||0.6|-0.7|<0.05
73830552|NCT03609177|147207758|SUPERIORITY||Risk Difference (RD)|0.7|||<|0.05|TWO_SIDED|95.0|-0.5|1.9|||binomial regression with identity link|||||1.90|-0.5|<0.05
73830553|NCT03609177|147207759|SUPERIORITY||Risk Difference (RD)|0.3|||<|0.05|TWO_SIDED|95.0|-0.4|1.0|||binomial regression with identity link|||||1.0|-0.4|<0.05
73830554|NCT04761822|147207939|SUPERIORITY||Risk Difference (RD)|0.026||||0.066|TWO_SIDED|95.0|-0.002|0.06||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.060|-0.002|0.066
73830555|NCT04761822|147207940|SUPERIORITY||Risk Difference (RD)|0.012||||0.267|TWO_SIDED|95.0|-0.016|0.042||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.042|-0.016|0.267
73830556|NCT04761822|147207941|SUPERIORITY||Risk Difference (RD)|0.016||||0.165|TWO_SIDED|95.0|-0.011|0.046||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.046|-0.011|0.165
73830557|NCT04761822|147207942|SUPERIORITY||Risk Difference (RD)|0.006||||0.572|TWO_SIDED|95.0|-0.021|0.033||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.033|-0.021|0.572
73830558|NCT04761822|147207943|SUPERIORITY||Risk Difference (RD)|0.016||||0.165|TWO_SIDED|95.0|-0.011|0.046|||Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.046|-0.011|0.165
73830559|NCT04761822|147207944|SUPERIORITY||Risk Difference (RD)|0.006||||0.572|TWO_SIDED|95.0|-0.021|0.033||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.033|-0.021|0.572
73830560|NCT04761822|147207945|SUPERIORITY||Risk Difference (RD)|0.015||||0.4574|TWO_SIDED|95.0|-0.045|0.055||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their first active dose as their first injection proportion minus the participants that received their first active dose as their second injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.055|-0.045|0.4574
73830561|NCT04761822|147207946|SUPERIORITY||Risk Difference (RD)|-0.016||||0.3242|TWO_SIDED|95.0|-0.086|0.018||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their first active dose as their first injection proportion minus the participants that received their first active dose as their second injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.018|-0.086|0.3242
73830562|NCT04761822|147207947|SUPERIORITY||Risk Difference (RD)|0.024||||0.31|TWO_SIDED|95.0|-0.037|0.07||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their second active dose as their second injection proportion minus the participants that received their second active dose as their third injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.070|-0.037|0.3100
73830563|NCT04761822|147207948|SUPERIORITY||Risk Difference (RD)|-0.007||||0.807|TWO_SIDED|95.0|-0.0783|0.0366||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their second active dose as their second injection proportion minus the participants that received their second active dose as their third injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.0366|-0.0783|0.8070
73830564|NCT04761822|147207949|SUPERIORITY||Risk Difference (RD)|0.001||||1|TWO_SIDED|95.0|-0.04|0.042||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the Pfizer-BioNTech COVID-19 vaccine first injection proportion minus comparison placebo first injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.042|-0.040|1.000
73830565|NCT04761822|147207950|SUPERIORITY||Risk Difference (RD)|-0.015||||0.25|TWO_SIDED|95.0|-0.053|0.018||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the Moderna COVID-19 vaccine first injection proportion minus comparison placebo first injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.018|-0.053|0.250
73830566|NCT04761822|147207951|SUPERIORITY||Risk Difference (RD)|0.058||||0.004|TWO_SIDED|95.0|0.024|0.101||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.101|0.024|0.004
73830567|NCT04761822|147207952|SUPERIORITY||Risk Difference (RD)|0.075|||<|0.001|TWO_SIDED|95.0|0.039|0.124||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.124|0.039|<0.001
73830568|NCT02631057|147207984|SUPERIORITY_OR_OTHER||Mean|-2.484|STANDARD_ERROR_OF_MEAN|0.629|<|0.001|TWO_SIDED|95.0|-3.717|-1.251|||Abadie-Imbens|LoS Average Treatment Effect on the Treated (ATET) \[Dabigatran group\], dispersion analysed with Abadie-Imbens's standard error.|The ATET of LoS from oral anticoagulant initiation to hospital discharge was calculated as \[Dabigatran - Warfarin\] in the matched cohort of matching ratio 1:3.|||-1.251|-3.717|<0.001
73830569|NCT02690727|147207998|SUPERIORITY_OR_OTHER||Ratio (%)|128.49||||0.0002|TWO_SIDED|90.0|119.13|138.59|||ANOVA|||||138.59|119.13|0.0002
73830570|NCT02690727|147208000|SUPERIORITY_OR_OTHER||Ratio (%)|139.27||||0.0278|TWO_SIDED|90.0|111.01|174.73|||ANOVA|||||174.73|111.01|0.0278
73830571|NCT00267670|147208054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.46|||||||ANOVA|||Sample size estimates were based on 30% reduction in ALT in the treatment group \& 15% reduction in the placebo group. With a sample size of 30 planned (20 treatment:10 placebo), the study was designed to have a power of 90% to detect a difference in means of 1.25 standard deviations (ES=1.25), \& a power of 80% to detect a difference in means of 1.1 standard deviations (ES=1.1), based on calculations using power index, z-table, \& accounting for unequal sample size: n1 = 20, n2 = 10, a = 0.05.||||0.46
73830572|NCT00267670|147208055|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||Null hypothesis was that there was no difference between mean hepatic expression of TNF-alpha receptors in patient with NASH. This was a secondary outcome and no power analysis was done.||||0.16
73830573|NCT00267670|147208056|SUPERIORITY_OR_OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
73830574|NCT00267670|147208057|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
73830575|NCT02326883|147208065|SUPERIORITY||Cox Proportional Hazard|1.07|STANDARD_ERROR_OF_MEAN|0.12||0.61|TWO_SIDED|95.0|0.86|1.33||A priori two-sided comparison of Care Management condition to Usual Care|Log Rank|A priori Bonferonni-corrected threshold for statistical significance was 0.025.|To clarify direction of comparison: relative hazard of suicide attempt among participants assigned to Care Management was 1.07 (95% CI 0.86 - 1.33) higher compared to participants assigned to Usual Care|Comparison of participants assigned to Care Management intervention to those assigned to continued Usual Care||1.33|0.86|0.61
73830576|NCT02326883|147208065|SUPERIORITY|A priori two-sided comparison of Skills Training to usual care.|Cox Proportional Hazard|1.29|STANDARD_ERROR_OF_MEAN|0.14||0.02|TWO_SIDED|95.0|1.05|1.59||A priori Bonferonni-corrected threshold for statistical significance was 0.025.|Log Rank||To clarify direction of comparison: relative hazard of suicide attempt in participants assigned to Skills Training was 1.29 (95% CI 1.05-1.59) times higher than in those assigned to Usual Care|Comparison of Skills Training to Usual Care||1.59|1.05|0.02
73830577|NCT04154956|147208066|SUPERIORITY||Hazard Ratio (HR)|1.143||||0.8204|TWO_SIDED|95.0|0.864|1.512||One-sided significance level was 0.01|Log Rank||Hazard ratio and confidence intervals (CIs) were computed from a stratified Cox model according to stratification factors as per IRT.|||1.512|0.864|0.8204
73830578|NCT04154956|147208067|SUPERIORITY||Hazard Ratio (HR)|0.846||||0.112|TWO_SIDED|95.0|0.644|1.109||One-sided significance level was 0.00174.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||1.109|0.644|0.1120
73830579|NCT04154956|147208068|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6972|TWO_SIDED|95.0|0.55|1.42||P-value is provided for information only, there is no statistical inference based on this P-value.|Cochran-Mantel-Haenszel||Odds ratio and its 2-sided CI were provided from a Cochran-Mantel-Haenszel (CMH) test stratified according to the stratification factors.|||1.42|0.55|0.6972
73830580|NCT04154956|147208069|SUPERIORITY||Hazard Ratio (HR)|0.729||||0.0157|TWO_SIDED|95.0|0.546|0.972||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||0.972|0.546|0.0157
73830581|NCT04154956|147208070|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.0002|TWO_SIDED|95.0|0.388|0.763||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||0.763|0.388|0.0002
73830582|NCT04154956|147208071|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0305|TWO_SIDED|95.0|0.533|1.014||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||1.014|0.533|0.0305
73830583|NCT03620162|147208106|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-3.4|||=|0.525|TWO_SIDED|95.0|-13.6|7.0|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 5 vs 1)||7.0|-13.6|= 0.525
73830584|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.5|||=|0.396|TWO_SIDED|95.0|-14.7|5.8|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 4 vs 1)||5.8|-14.7|= 0.396
73830585|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.7|||=|0.097|TWO_SIDED|95.0|-18.8|1.6|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 3 vs 1)||1.6|-18.8|= 0.097
73830586|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-9.9|||=|0.057|TWO_SIDED|95.0|-19.9|0.3|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 2 vs 1)||0.3|-19.9|= 0.057
73830587|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.4|||=|0.085|TWO_SIDED|95.0|-17.8|1.2|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 5 vs 1)||1.2|-17.8|= 0.085
73830588|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-9.5|||=|0.05|TWO_SIDED|95.0|-18.9|0.0|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 4 vs 1)||-0.0|-18.9|= 0.050
73830589|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-6.5|||=|0.183|TWO_SIDED|95.0|-16.1|3.1|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 3 vs 1)||3.1|-16.1|= 0.183
73830590|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.7|||=|0.074|TWO_SIDED|95.0|-18.1|0.8|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 2 vs 1)||0.8|-18.1|= 0.074
73830591|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|3.4|||=|0.525|TWO_SIDED|95.0|-7.0|13.6|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 5 vs 1)||13.6|-7.0|= 0.525
73830592|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.915|TWO_SIDED|95.0|-10.8|9.7|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 4 vs 1)||9.7|-10.8|= 0.915
73830593|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.9|||=|0.714|TWO_SIDED|95.0|-8.4|12.2|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 3 vs 1)||12.2|-8.4|= 0.714
73830594|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.5|||=|0.926|TWO_SIDED|95.0|-10.7|9.7|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 2 vs 1)||9.7|-10.7|= 0.926
73830595|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||>|0.999|TWO_SIDED|95.0|-8.7|8.7|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 5 vs 1)||8.7|-8.7|> 0.999
73830596|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-2.2|||=|0.609|TWO_SIDED|95.0|-10.8|6.4|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 4 vs 1)||6.4|-10.8|= 0.609
73830597|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.8|||=|0.688|TWO_SIDED|95.0|-7.1|10.7|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 3 vs 1)||10.7|-7.1|= 0.688
73830598|NCT03620162|147208106|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.1|||=|0.336|TWO_SIDED|95.0|-12.6|4.3|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 2 vs 1)||4.3|-12.6|= 0.336
73830599|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.1|||=|0.825|TWO_SIDED|95.0|-11.0|8.8|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group5 vs1)||8.8|-11.0|= 0.825
73830600|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.912|TWO_SIDED|95.0|-10.4|9.3|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group4 vs1)||9.3|-10.4|= 0.912
73830601|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.8|||=|0.074|TWO_SIDED|95.0|-18.3|0.9|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group3 vs1)||0.9|-18.3|= 0.074
73830602|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Percentage of Participants|-3.7|||=|0.458|TWO_SIDED|95.0|-13.4|6.1|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group2 vs1)||6.1|-13.4|= 0.458
73830603|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|2.8|||=|0.568|TWO_SIDED|95.0|-6.8|12.3|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 5 vs1)||12.3|-6.8|= 0.568
73830604|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.6|||=|0.91|TWO_SIDED|95.0|-9.1|10.2|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 4 vs1)||10.2|-9.1|= 0.910
73830605|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.7|||=|0.354|TWO_SIDED|95.0|-14.5|5.2|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 3 vs1)||5.2|-14.5|= 0.354
73830606|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-6.8|||=|0.178|TWO_SIDED|95.0|-16.6|3.1|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 2 vs1)||3.1|-16.6|= 0.178
73830607|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|3.4|||=|0.52|TWO_SIDED|95.0|-6.8|13.5|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 5 vs 1)||13.5|-6.8|= 0.520
73830608|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||>|0.999|TWO_SIDED|95.0|-10.2|10.2|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 4 vs 1)||10.2|-10.2|> 0.999
73830609|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.2|||=|0.963|TWO_SIDED|95.0|-10.5|10.0|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 3 vs 1)||10.0|-10.5|= 0.963
73830610|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.2|||=|0.821|TWO_SIDED|95.0|-11.4|9.0|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 2 vs 1)||9.0|-11.4|= 0.821
73830611|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.836|TWO_SIDED|95.0|-6.1|5.0|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 5 vs 1)||5.0|-6.1|= 0.836
73830612|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.7|||=|0.562|TWO_SIDED|95.0|-4.2|7.6|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 4 vs 1)||7.6|-4.2|= 0.562
73830613|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.6|||=|0.527|TWO_SIDED|95.0|-7.1|3.7|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 3 vs 1)||3.7|-7.1|= 0.527
73830614|NCT03620162|147208107|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-3.4|||=|0.16|TWO_SIDED|95.0|-8.6|1.5|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 2 vs 1)||1.5|-8.6|= 0.160
73830615|NCT03620162|147208108|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 5 vs 1)||2.1|-2.1|
73830616|NCT03620162|147208108|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 4 vs 1)||2.1|-2.1|
73830617|NCT03620162|147208108|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.6|||||TWO_SIDED|95.0|-1.6|3.1||||||Difference in Percentage (Group 3 vs 1)||3.1|-1.6|
73830618|NCT03620162|147208108|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 2 vs 1)||2.1|-2.1|
73830619|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.0||||||GMC Ratio: Serotype 1 (Group 4 vs 1)||1.00|0.69|
73830620|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||GMC Ratio: Serotype 1 (Group 3 vs 1)||1.12|0.77|
73830621|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|1.0||||||GMC Ratio: Serotype 1 (Group 2 vs 1)||1.00|0.70|
73830622|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.01|||||TWO_SIDED|95.0|0.86|1.19||||||GMC Ratio: Serotype 3 (Group 4 vs 1)||1.19|0.86|
73830623|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.12||||||GMC Ratio: Serotype 3 (Group 3 vs 1)||1.12|0.80|
73830624|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||GMC Ratio: Serotype 3 (Group 2 vs 1)||1.25|0.90|
73830625|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.66|1.0||||||GMC Ratio: Serotype 4 (Group 4 vs 1)||1.00|0.66|
73830626|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.68|1.03||||||GMC Ratio: Serotype 4 (Group 3 vs 1)||1.03|0.68|
73830627|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08||||||GMC Ratio: Serotype 4 (Group 2 vs 1)||1.08|0.72|
73830628|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.98||||||GMC Ratio: Serotype 5 (Group 4 vs 1)||0.98|0.64|
73830629|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||GMC Ratio: Serotype 5 (Group 3 vs 1)||1.29|0.84|
73830630|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.75|1.14||||||GMC Ratio: Serotype 5 (Group 2 vs 1)||1.14|0.75|
73830631|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.66|0.98||||||GMC Ratio: Serotype 6A (Group 4 vs 1)||0.98|0.66|
73830632|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.11|||||TWO_SIDED|95.0|0.91|1.37||||||GMC Ratio: Serotype 6A (Group 3 vs 1)||1.37|0.91|
73830633|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.92|1.36||||||GMC Ratio: Serotype 6A (Group 2 vs 1)||1.36|0.92|
73830634|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.31||||||GMC Ratio: Serotype 6B (Group 4 vs 1)||1.31|0.88|
73830635|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.32||||||GMC Ratio: Serotype 6B (Group 3 vs 1)||1.32|0.88|
73830636|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.23|||||TWO_SIDED|95.0|1.02|1.49||||||GMC Ratio: Serotype 6B (Group 2 vs 1)||1.49|1.02|
73830637|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.64|0.95||||||GMC Ratio: Serotype 7F (Group 4 vs 1)||0.95|0.64|
73830638|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.81|1.21||||||GMC Ratio: Serotype 7F (Group 3 vs 1)||1.21|0.81|
73830639|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.11|||||TWO_SIDED|95.0|0.92|1.35||||||GMC Ratio: Serotype 7F (Group 2 vs 1)||1.35|0.92|
73830640|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||GMC Ratio: Serotype 9V (Group 4 vs 1)||1.01|0.70|
73830641|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06||||||GMC Ratio: Serotype 9V (Group 3 vs 1)||1.06|0.73|
73830642|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.79|1.13||||||GMC Ratio: Serotype 9V (Group 2 vs 1)||1.13|0.79|
73830643|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.83|1.28||||||GMC Ratio: Serotype 14 (Group 4 vs 1)||1.28|0.83|
73830644|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.15|1.78||||||GMC Ratio: Serotype 14 (Group 3 vs 1)||1.78|1.15|
73830645|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.39|||||TWO_SIDED|95.0|1.13|1.71||||||GMC Ratio: Serotype 14 (Group 2 vs 1)||1.71|1.13|
73830646|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.07|||||TWO_SIDED|95.0|0.88|1.3||||||GMC Ratio: Serotype 18C (Group 4 vs 1)||1.30|0.88|
73830647|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.44|||||TWO_SIDED|95.0|1.18|1.76||||||GMC Ratio: Serotype 18C (Group 3 vs 1)||1.76|1.18|
73830648|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.51|||||TWO_SIDED|95.0|1.25|1.83||||||GMC Ratio: Serotype 18C (Group 2 vs 1)||1.83|1.25|
73830649|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.69|1.01||||||GMC Ratio: Serotype 19A (Group 4 vs 1)||1.01|0.69|
73830650|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||GMC Ratio: Serotype 19A (Group 3 vs 1)||1.07|0.72|
73830651|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.13||||||GMC Ratio: Serotype 19A (Group 2 vs 1)||1.13|0.77|
73830652|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.96|||||TWO_SIDED|95.0|0.81|1.15||||||GMC Ratio: Serotype 19F (Group 4 vs 1)||1.15|0.81|
73830653|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.26||||||GMC Ratio: Serotype 19F (Group 3 vs 1)||1.26|0.88|
73830654|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.21||||||GMC Ratio: Serotype 19F (Group 2 vs 1)||1.21|0.86|
73830655|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.61|0.96||||||GMC Ratio: Serotype 23F (Group 4 vs 1)||0.96|0.61|
73830656|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.63|0.99||||||GMC Ratio: Serotype 23F (Group 3 vs 1)||0.99|0.63|
73830657|NCT03620162|147208109|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.76|1.17||||||GMC Ratio: Serotype 23F (Group 2 vs 1)||1.17|0.76|
73830658|NCT03620162|147208110|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the difference in percentages (Group 5/Group 1+Group 2) to be \>-10 percentage points.|Difference in Percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-3.7|2.0|||Miettinen & Nurminen method|||Difference in Percentage (Group 5 vs Group 1+2)||2.0|-3.7|< 0.001
73830659|NCT03620162|147208111|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the GMT ratio (Group 5/Group 1+Group 2) to be \>0.5.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.7|1.34|||ANCOVA|||GMT Ratio (Group 5 vs Group 1+2)||1.34|0.70|< 0.001
73830660|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.6|0.86||||||GMC Ratio: Serotype 1 (Group 5 vs 1)||0.86|0.60|
73830661|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.22|||||TWO_SIDED|95.0|1.04|1.44||||||GMC Ratio: Serotype 3 (Group 5 vs 1)||1.44|1.04|
73830662|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.73|1.1||||||GMC Ratio: Serotype 4 (Group 5 vs 1)||1.10|0.73|
73830663|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.97||||||GMC Ratio: Serotype 5 (Group 5 vs 1)||0.97|0.64|
73830664|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.69|||||TWO_SIDED|95.0|0.57|0.84||||||GMC Ratio: Serotype 6A (Group 5 vs 1)||0.84|0.57|
73830665|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.95|||||TWO_SIDED|95.0|0.78|1.15||||||GMC Ratio: Serotype 6B (Group 5 vs 1)||1.15|0.78|
73830666|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.67|||||TWO_SIDED|95.0|0.55|0.82||||||GMC Ratio: Serotype 7F (Group 5 vs 1)||0.82|0.55|
73830667|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.82|1.18||||||GMC Ratio: Serotype 9V (Group 5 vs 1)||1.18|0.82|
73830668|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.7|1.07||||||GMC Ratio: Serotype 14 (Group 5 vs 1)||1.07|0.70|
73830669|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||GMC Ratio: Serotype 18C (Group 5 vs 1)||1.25|0.85|
73830670|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.65|0.95||||||GMC Ratio: Serotype 19A (Group 5 vs 1)||0.95|0.65|
73830671|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||GMC Ratio: Serotype 19F (Group 5 vs 1)||1.02|0.72|
73830672|NCT03620162|147208114|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.73|||||TWO_SIDED|95.0|0.59|0.91||||||GMC Ratio: Serotype 23F (Group 5 vs 1)||0.91|0.59|
73830673|NCT02763566|147208128|SUPERIORITY||Hazard Ratio (HR)|0.499||||0.0001|TWO_SIDED|95.0|0.346|0.719|||Log Rank|||||0.719|0.346|0.0001
73830674|NCT02763566|147208129|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.24|0.588|||Log Rank|||||0.588|0.240|<0.0001
73830675|NCT02763566|147208131|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73830676|NCT02763566|147208131|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73830677|NCT02763566|147208133|SUPERIORITY|||||||0.0456|||||||Cochran-Mantel-Haenszel|||||||0.0456
73830678|NCT02763566|147208133|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
73830679|NCT02763566|147208134|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
73830680|NCT02763566|147208134|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73830681|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-1.89|STANDARD_ERROR_OF_MEAN|1.77||0.287|TWO_SIDED|95.0|-5.36|1.59|||Mixed Models Analysis|||Global Health Status||1.59|-5.36|0.287
73830682|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.46||0.597|TWO_SIDED|95.0|-3.64|2.1|||Mixed Models Analysis|||Functional Scales - Physical functioning||2.10|-3.64|0.597
73830683|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-0.31|STANDARD_ERROR_OF_MEAN|2.15||0.885|TWO_SIDED|95.0|-4.55|3.93|||Mixed Models Analysis|||Functional Scales - Role Functioning||3.93|-4.55|0.885
73830684|NCT02763566|147208135|SUPERIORITY||LSMean Difference|1.67|STANDARD_ERROR_OF_MEAN|1.74||0.34|TWO_SIDED|95.0|-1.77|5.1|||Mixed Models Analysis|||Functional Scales - Emotional Functioning||5.10|-1.77|0.340
73830685|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-2.17|STANDARD_ERROR_OF_MEAN|1.62||0.182|TWO_SIDED|95.0|-5.37|1.03|||Mixed Models Analysis|||Functional Scales - Cognitive Functioning||1.03|-5.37|0.182
73830686|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-0.88|STANDARD_ERROR_OF_MEAN|2.12||0.678|TWO_SIDED|95.0|-5.05|3.29|||Mixed Models Analysis|||||3.29|-5.05|0.678
73830687|NCT02763566|147208135|SUPERIORITY||LSMean Difference|1.57|STANDARD_ERROR_OF_MEAN|1.7||0.355|TWO_SIDED|95.0|-1.77|4.91|||Mixed Models Analysis|||Symptom Scales - Fatigue||4.91|-1.77|0.355
73830688|NCT02763566|147208135|SUPERIORITY||LSMean Difference|0.95|STANDARD_ERROR_OF_MEAN|1.06||0.372|TWO_SIDED|95.0|-1.14|3.03|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting||3.03|-1.14|0.372
73830689|NCT02763566|147208135|SUPERIORITY||LSMean Difference|0.74|STANDARD_ERROR_OF_MEAN|1.63||0.74|TWO_SIDED|95.0|-3.75|2.66|||Mixed Models Analysis|||Symptom Scales - Pain||2.66|-3.75|0.740
73830690|NCT02763566|147208135|SUPERIORITY||LSMean Difference|2.16|STANDARD_ERROR_OF_MEAN|1.84||0.24|TWO_SIDED|95.0|-1.46|5.78|||Mixed Models Analysis|||Symptom Scales - Dyspnoea||5.78|-1.46|0.240
73830691|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-0.81|STANDARD_ERROR_OF_MEAN|1.92||0.673|TWO_SIDED|95.0|-4.6|2.97|||Mixed Models Analysis|||Symptom scales - Insomnia||2.97|-4.60|0.673
73830692|NCT02763566|147208135|SUPERIORITY||LSMean Difference|5.65|STANDARD_ERROR_OF_MEAN|1.74||0.001|TWO_SIDED|95.0|2.23|9.07|||Mixed Models Analysis|||Symptom Scales - Appetite||9.07|2.23|0.001
73830693|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.76||0.375|TWO_SIDED|95.0|-5.04|1.91|||Mixed Models Analysis|||Symptom Scales - Constipation||1.91|-5.04|0.375
73830694|NCT02763566|147208135|SUPERIORITY||LSMean Difference|15.82|STANDARD_ERROR_OF_MEAN|1.53||0|TWO_SIDED|95.0|12.81|18.84|||Mixed Models Analysis|||Symptom Scales - Diarrhoea||18.84|12.81|0.000
73830695|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-1.75|STANDARD_ERROR_OF_MEAN|2.97||0.557|TWO_SIDED|95.0|-7.59|4.1|||Mixed Models Analysis|||Symptom Scales - Financial Difficulties||4.10|-7.59|0.557
73830696|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-3.47|STANDARD_ERROR_OF_MEAN|2.51||0.169|TWO_SIDED|95.0|-8.43|1.49|||Mixed Models Analysis|||Global Health Status||1.49|-8.43|0.169
73830697|NCT02763566|147208135|SUPERIORITY||LSMean Difference|1.58|STANDARD_ERROR_OF_MEAN|1.87||0.4|TWO_SIDED|95.0|-2.12|5.29|||Mixed Models Analysis|||Functional Scales - Physical Functioning||5.29|-2.12|0.400
73830698|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-1.72|STANDARD_ERROR_OF_MEAN|2.38||0.472|TWO_SIDED|95.0|-6.42|2.99|||Mixed Models Analysis|||Functional Scales - Role functioning||2.99|-6.42|0.472
73830699|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-2.42|STANDARD_ERROR_OF_MEAN|0.31||0.31|TWO_SIDED|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Emotional Functioning||2.28|-7.12|0.310
73830700|NCT02763566|147208135|SUPERIORITY||LSMean Difference|0.64|STANDARD_ERROR_OF_MEAN|2.98||0.83|TWO_SIDED|95.0|-5.26|6.55|||Mixed Models Analysis|||Functional Scales - Social Functioning||6.55|-5.26|0.830
73830701|NCT02763566|147208135|SUPERIORITY||LSMean Difference|2.73|STANDARD_ERROR_OF_MEAN|2.52||0.281|TWO_SIDED|95.0|-2.26|7.72|||Mixed Models Analysis|||Symptom Scales - Fatigue||7.72|-2.26|0.281
73830702|NCT02763566|147208135|SUPERIORITY||LSMean Difference|2.59|STANDARD_ERROR_OF_MEAN|1.99||0.194|TWO_SIDED|95.0|-1.33|6.52|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting||6.52|-1.33|0.194
73830703|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-2.66|STANDARD_ERROR_OF_MEAN|2.42||0.275|TWO_SIDED|95.0|-7.45|2.14|||Mixed Models Analysis|||Symptom Scales - Pain||2.14|-7.45|0.275
73830704|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-2.49|STANDARD_ERROR_OF_MEAN|4.39||0.28|TWO_SIDED|95.0|-7.04|2.06|||Mixed Models Analysis|||Symptom Scales - Dyspnoea||2.06|-7.04|0.280
73830705|NCT02763566|147208135|SUPERIORITY||LSMean Difference|1.97|STANDARD_ERROR_OF_MEAN|2.9||0.499|TWO_SIDED|95.0|-3.78|7.72|||Mixed Models Analysis|||Symptom Scales - Insomnia||7.72|-3.78|0.499
73830706|NCT02763566|147208135|SUPERIORITY||LSMean Difference|7.46|STANDARD_ERROR_OF_MEAN|2.92||0.012|TWO_SIDED|95.0|1.68|13.23|||Mixed Models Analysis|||Symptom Scales - Appetite||13.23|1.68|0.012
73830707|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-2.28|STANDARD_ERROR_OF_MEAN|2.29||0.321|TWO_SIDED|95.0|-6.83|2.27|||Mixed Models Analysis|||Symptom Scales - Constipation||2.27|-6.83|0.321
73830708|NCT02763566|147208135|SUPERIORITY||LSMean Difference|17.83|STANDARD_ERROR_OF_MEAN|2.32||0|TWO_SIDED|95.0|13.25|22.41|||Mixed Models Analysis|||Symptom Scales - Diarrhoea||22.41|13.25|0.000
73830709|NCT02763566|147208135|SUPERIORITY||LSMean Difference|2.99|STANDARD_ERROR_OF_MEAN|3.14||0.342|TWO_SIDED|95.0|-3.21|9.19|||Mixed Models Analysis|||Symptom Scales - Financial DIfficulties||9.19|-3.21|0.342
73830710|NCT02763566|147208135|SUPERIORITY||LSMean Difference|-2.42|STANDARD_ERROR_OF_MEAN|2.38||0.31|TWO_SIDED|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Cognitive functioning||2.28|-7.12|0.310
73830711|NCT00315445|147208137|SUPERIORITY_OR_OTHER|||||||0.035||||||P values are from a repeated measures model|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P \< 0.10, using a backward elimination procedure.||||0.0350
73830712|NCT00315445|147208137|SUPERIORITY_OR_OTHER|||||||0.0624||||||Repeated measures analysis to assess the effects due to treatment, center, and treatment by center. Missing values = last observation carried forward (LOCF). Covariates: gender, age, race, weight, baseline pain, and previous opioid use.|Mixed Models Analysis|||||||0.0624
73830713|NCT00315445|147208138|SUPERIORITY_OR_OTHER||Day 84 Mean|46.4|||||TWO_SIDED|90.0|40.2|48.7|||Day 84 Mean|||||48.7|40.2|
73830714|NCT00315445|147208138|SUPERIORITY_OR_OTHER||Day 84 Mean|44.5|||||TWO_SIDED|90.0|43.3|52.4|||Day 84 Mean|||||52.4|43.3|
73830715|NCT00315445|147208138|SUPERIORITY_OR_OTHER||Day 84 Mean|46.5|||||TWO_SIDED|90.0|41.7|50.2|||Day 84 Mean|||||50.2|41.7|
73830716|NCT00315445|147208139|SUPERIORITY_OR_OTHER||Day 84 Mean|18.9|||||TWO_SIDED|90.0|5.2|26.2|||Day 84 Mean|||||26.2|5.2|
73830717|NCT00315445|147208139|SUPERIORITY_OR_OTHER||Day 84 Mean|24.4|||||TWO_SIDED|90.0|10.7|32.0|||Day 84 Mean|||||32.0|10.7|
73830718|NCT00315445|147208139|SUPERIORITY_OR_OTHER||Day 84 Mean|33.9|||||TWO_SIDED|90.0|16.0|35.2|||Day 84 Mean|||||35.2|16.0|
73830719|NCT00315445|147208140|SUPERIORITY_OR_OTHER|||||||0.0452||||||Multiple linear regression|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P \< 0.10, using a backward elimination procedure.||||0.0452
73830720|NCT00315445|147208140|SUPERIORITY_OR_OTHER|||||||0.0962|||||||Mixed Models Analysis|||||||0.0962
73830721|NCT00315445|147208141|SUPERIORITY_OR_OTHER||Day 84 Mean|35.3|||||TWO_SIDED|90.0|24.3|35.6|||Day 84 Mean|||||35.6|24.3|
73830722|NCT00315445|147208141|SUPERIORITY_OR_OTHER||Day 84 Mean|39.0|||||TWO_SIDED|90.0|29.0|40.3|||Day 84 Mean|||||40.3|29.0|
73830723|NCT00315445|147208141|SUPERIORITY_OR_OTHER||Day 84 Mean|41.9|||||TWO_SIDED|90.0|32.1|42.5|||Day 84 Mean|||||42.5|32.1|
73830724|NCT00315445|147208142|SUPERIORITY_OR_OTHER||Day 84 Mean|52.4||||||90.0|50.3|56.6|||Day 84 Mean|||||56.6|50.3|
73830725|NCT00315445|147208142|SUPERIORITY_OR_OTHER||Day 84 Mean|52.5|||||TWO_SIDED|90.0|51.8|58.3|||Day 84 Mean|||||58.3|51.8|
73830726|NCT00315445|147208142|SUPERIORITY_OR_OTHER||Day 84 Mean|57.7|||||TWO_SIDED|90.0|52.3|58.6|||Day 84 Mean|||||58.6|52.3|
73830727|NCT00315445|147208145|SUPERIORITY_OR_OTHER||Day 84 Mean|55.3|||||TWO_SIDED|90.0|49.8|67.9|||Day 84 Mean|||||67.9|49.8|
73830728|NCT00315445|147208145|SUPERIORITY_OR_OTHER||Day 84 Mean|56.3|||||TWO_SIDED|90.0|45.9|65.3|||Day 84 Mean|||||65.3|45.9|
73830729|NCT00315445|147208145|SUPERIORITY_OR_OTHER||Day 84 Mean|63.0|||||TWO_SIDED|90.0|53.1|70.9|||Day 84 Mean|||||70.9|53.1|
73830730|NCT00315445|147208146|SUPERIORITY_OR_OTHER||Day 84 Mean|67.4|||||TWO_SIDED|90.0|61.3|68.6|||Day 84 Mean|||||68.6|61.3|
73830731|NCT00315445|147208146|SUPERIORITY_OR_OTHER||Day 84 Mean|68.8|||||TWO_SIDED|90.0|61.7|68.8|||Day 84 Mean|||||68.8|61.7|
73830732|NCT00315445|147208146|SUPERIORITY_OR_OTHER||Day 84 Mean|67.8|||||TWO_SIDED|90.0|62.0|68.7|||Day 84 Mean|||||68.7|62.0|
73830733|NCT00315445|147208151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.67||||0.054|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.054
73830734|NCT00315445|147208151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.138|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.138
73830735|NCT00315445|147208152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0105|||||||Regression, Cox|For the secondary outcomes no alpha adjustment for multiple comparison was performed.||||||0.0105
73830736|NCT00315445|147208152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.04||||0.0024|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.0024
73830737|NCT00315445|147208153|SUPERIORITY_OR_OTHER|||||||0.033|||||||Mixed Models Analysis|||||||.033
73830738|NCT00315445|147208153|SUPERIORITY_OR_OTHER|||||||0.043|||||||Mixed Models Analysis|||||||.043
73830739|NCT00315445|147208154|SUPERIORITY_OR_OTHER|||||||0.011|||||||Mixed Models Analysis|||||||.011
73830740|NCT00315445|147208154|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||||||.034
73830741|NCT00315445|147208155|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||.038
73830742|NCT00315445|147208155|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mixed Models Analysis|||||||0.63
73830743|NCT00315445|147208156|SUPERIORITY_OR_OTHER|||||||0.064|||||||Mixed Models Analysis|||||||.064
73830744|NCT00315445|147208156|SUPERIORITY_OR_OTHER|||||||0.066|||||||Mixed Models Analysis|||||||.066
73830745|NCT00315445|147208157|SUPERIORITY_OR_OTHER|||||||0.607|||||||Mixed Models Analysis|||||||.607
73830746|NCT00315445|147208157|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||||||.940
73830747|NCT00315445|147208158|SUPERIORITY_OR_OTHER|||||||0.702|||||||Mixed Models Analysis|||||||.702
73830748|NCT00315445|147208158|SUPERIORITY_OR_OTHER|||||||0.634|||||||Mixed Models Analysis|||||||.634
73830749|NCT01101178|147208170|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|110.0|||||TWO_SIDED|90.0|105.21|114.47|||ANOVA||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||114.47|105.21|
73830750|NCT01101178|147208171|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.7|||||TWO_SIDED|90.0|92.71|96.64|||ANOVA||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||96.64|92.71|
73830751|NCT01101178|147208172|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.9|||||TWO_SIDED|90.0|92.9|97.02|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.02|92.90|
73830752|NCT00846365|147208194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-8.4|-3.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and Baseline as a covariate.||-3.8|-8.4|<0.001
73830753|NCT00846365|147208194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.001|TWO_SIDED|95.0|-9.1|-4.4||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-4.4|-9.1|<0.001
73830754|NCT00846365|147208195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-8.5|-3.7||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-3.7|-8.5|<0.001
73830755|NCT00846365|147208195|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-9.6|-4.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-4.8|-9.6|<0.001
73830756|NCT00846365|147208199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-7.5|-3.7||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.||-3.7|-7.5|<0.001
73830757|NCT00846365|147208199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-9.1|-5.2||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.||-5.2|-9.1|<0.001
73830758|NCT03479905|147208210|SUPERIORITY|||||||0.0004|||||||Kruskal-Wallis|||||||0.0004
73830759|NCT00720759|147208218|SUPERIORITY_OR_OTHER||Slope|0.83|STANDARD_ERROR_OF_MEAN|8.54|<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||A general linear model was employed. The independent variables were baseline WMFT score, treatment (condensed vs distributed), treatment (d-cycloserine vs placebo), and treatment interaction effect. The dependent measure was WMFT score at 3 months post treatment.||||<0.05
73830760|NCT02696798|147208239|SUPERIORITY||Odds Ratio (OR)|2.41||||0.017|TWO_SIDED|95.0|1.17|4.95|||Regression, Logistic|||||4.95|1.17|0.017
73830761|NCT02696798|147208239|SUPERIORITY||Odds Ratio (OR)|3.06||||0.003|TWO_SIDED|95.0|1.48|6.33|||Regression, Logistic|||||6.33|1.48|0.003
73830762|NCT02696798|147208240|SUPERIORITY||Odds Ratio (OR)|2.2||||0.006|TWO_SIDED|95.0|1.26|3.84|||Regression, Logistic|||||3.84|1.26|0.006
73830763|NCT02696798|147208240|SUPERIORITY||Odds Ratio (OR)|2.08||||0.013|TWO_SIDED|95.0|1.16|3.73|||Regression, Logistic|||||3.73|1.16|0.013
73830764|NCT02696798|147208241|SUPERIORITY||LS Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.135|<|0.001|TWO_SIDED|95.0|-1.32|-0.79|||Mixed Models Analysis|||||-0.79|-1.32|<0.001
73830765|NCT02696798|147208241|SUPERIORITY||LS Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.3|-0.75|||Mixed Models Analysis|||||-0.75|-1.30|<0.001
73830766|NCT02696798|147208242|SUPERIORITY||Odds Ratio (OR)|2.65||||0.015|TWO_SIDED|95.0|1.21|5.84|||Regression, Logistic|||||5.84|1.21|0.015
73830767|NCT02696798|147208242|SUPERIORITY||Odds Ratio (OR)|2.9||||0.01|TWO_SIDED|95.0|1.29|6.49|||Regression, Logistic|||||6.49|1.29|0.010
73830768|NCT02696798|147208243|SUPERIORITY||LS Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.291|<|0.001|TWO_SIDED|95.0|-1.81|-0.67|||Mixed Models Analysis|||||-0.67|-1.81|<0.001
73830769|NCT02696798|147208243|SUPERIORITY||LS Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.301|<|0.001|TWO_SIDED|95.0|-1.76|-0.57|||Mixed Models Analysis|||||-0.57|-1.76|<0.001
73830770|NCT02696798|147208244|SUPERIORITY||LS Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.295|<|0.001|TWO_SIDED|95.0|-1.63|-0.47|||Mixed Models Analysis|||||-0.47|-1.63|<0.001
73830771|NCT02696798|147208244|SUPERIORITY||LS Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.307|<|0.001|TWO_SIDED|95.0|-1.89|-0.68|||Mixed Models Analysis|||||-0.68|-1.89|<0.001
73830772|NCT02696798|147208245|SUPERIORITY||Odds Ratio (OR)|3.73||||0.242|TWO_SIDED|95.0|0.41|33.98|||Regression, Logistic|||||33.98|0.41|0.242
73830773|NCT02696798|147208245|SUPERIORITY||Odds Ratio (OR)|5.42||||0.127|TWO_SIDED|95.0|0.62|47.54|||Regression, Logistic|||||47.54|0.62|0.127
73830774|NCT02696798|147208246|SUPERIORITY||Odds Ratio (OR)|4.22||||0.006|TWO_SIDED|95.0|1.5|11.86|||Regression, Logistic|||||11.86|1.50|0.006
73830775|NCT02696798|147208246|SUPERIORITY||Odds Ratio (OR)|4.52||||0.006|TWO_SIDED|95.0|1.55|13.18|||Regression, Logistic|||||13.18|1.55|0.006
73830776|NCT02696798|147208247|SUPERIORITY||LS Mean Difference (Final Values)|0.7689|STANDARD_ERROR_OF_MEAN|1.2863||0.55|TWO_SIDED|95.0|-1.7629|3.3007|||Mixed Models Analysis|||MCS||3.3007|-1.7629|0.550
73830777|NCT02696798|147208247|SUPERIORITY||LS Mean Difference (Final Values)|0.9104|STANDARD_ERROR_OF_MEAN|1.3338||0.495|TWO_SIDED|95.0|-1.7151|3.536|||Mixed Models Analysis|||MCS||3.5360|-1.7151|0.495
73830778|NCT02696798|147208247|SUPERIORITY||LS Mean Difference (Final Values)|5.2147|STANDARD_ERROR_OF_MEAN|1.1149|<|0.001|TWO_SIDED|95.0|3.0204|7.409|||Mixed Models Analysis|||PCS||7.4090|3.0204|<0.001
73830779|NCT02696798|147208247|SUPERIORITY||LS Mean Difference (Final Values)|4.7585|STANDARD_ERROR_OF_MEAN|1.1505|<|0.001|TWO_SIDED|95.0|2.494|7.023|||Mixed Models Analysis|||PCS||7.0230|2.4940|<0.001
73830780|NCT02696798|147208248|SUPERIORITY||LS Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.46||0.026|TWO_SIDED|95.0|-1.94|-0.13|||Mixed Models Analysis|||||-0.13|-1.94|0.026
73830781|NCT02696798|147208248|SUPERIORITY||LS Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.477||0.149|TWO_SIDED|95.0|-1.63|0.25|||Mixed Models Analysis|||||0.25|-1.63|0.149
73830782|NCT02696798|147208249|SUPERIORITY||LS Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.512|<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||ANCOVA|||||-0.9|-3.0|<0.001
73830783|NCT02696798|147208249|SUPERIORITY||LS Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.534|<|0.001|TWO_SIDED|95.0|-3.2|-1.1|||ANCOVA|||||-1.1|-3.2|<0.001
73830784|NCT02696798|147208250|SUPERIORITY||LS Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|1.896||0.001|TWO_SIDED|95.0|-10.0|-2.5|||ANCOVA|||||-2.5|-10.0|0.001
73830785|NCT02696798|147208250|SUPERIORITY||LS Mean Difference (Final Values)|-7.27|STANDARD_ERROR_OF_MEAN|1.978|<|0.001|TWO_SIDED|95.0|-11.2|-3.4|||ANCOVA|||||-3.4|-11.2|<0.001
73830786|NCT02696798|147208251|SUPERIORITY||LS Mean Difference (Final Values)|-20.816|STANDARD_ERROR_OF_MEAN|3.7463|<|0.001|TWO_SIDED|95.0|-28.187|-13.444|||Mixed Models Analysis|||||-13.444|-28.187|<0.001
73830787|NCT02696798|147208251|SUPERIORITY||LS Mean Difference (Final Values)|-17.841|STANDARD_ERROR_OF_MEAN|3.9018|<|0.001|TWO_SIDED|95.0|-25.518|-10.163|||Mixed Models Analysis|||||-10.163|-25.518|<0.001
73830788|NCT02696798|147208252|SUPERIORITY||LS Mean Difference (Final Values)|-0.304|STANDARD_ERROR_OF_MEAN|0.1275||0.018|TWO_SIDED|95.0|-0.555|-0.053|||Mixed Models Analysis|||||-0.053|-0.555|0.018
73830789|NCT02696798|147208252|SUPERIORITY||LS Mean Difference (Final Values)|-0.172|STANDARD_ERROR_OF_MEAN|0.1319||0.194|TWO_SIDED|95.0|-0.431|0.088|||Mixed Models Analysis|||||0.088|-0.431|0.194
73830790|NCT02696798|147208253|SUPERIORITY||LS Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|0.893||0.17|TWO_SIDED|95.0|-0.53|2.99|||Mixed Models Analysis|||||2.99|-0.53|0.170
73830791|NCT02696798|147208253|SUPERIORITY||LS Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.916||0.8|TWO_SIDED|95.0|-1.57|2.04|||Mixed Models Analysis|||||2.04|-1.57|0.800
73830792|NCT02696798|147208254|SUPERIORITY||LS Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.521||0.547|TWO_SIDED|95.0|-1.34|0.71|||Mixed Models Analysis|||||0.71|-1.34|0.547
73830793|NCT02696798|147208254|SUPERIORITY||LS Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.538||0.064|TWO_SIDED|95.0|-2.06|0.06|||Mixed Models Analysis|||||0.06|-2.06|0.064
73830794|NCT02696798|147208255|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.861|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|||||1.3|-1.0|0.861
73830795|NCT02696798|147208255|SUPERIORITY||LS Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.59||0.626|TWO_SIDED|95.0|-1.4|0.9|||Mixed Models Analysis|||||0.9|-1.4|0.626
73830796|NCT02696798|147208256|SUPERIORITY||LS Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.59||0.504|TWO_SIDED|95.0|-1.6|0.8|||Mixed Models Analysis|||||0.8|-1.6|0.504
73830797|NCT02696798|147208256|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.86|TWO_SIDED|95.0|-1.1|1.3|||Mixed Models Analysis|||||1.3|-1.1|0.860
73830798|NCT02696798|147208257|SUPERIORITY||LS Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.03||0.362|TWO_SIDED|95.0|-3.0|1.1|||Mixed Models Analysis|||||1.1|-3.0|0.362
73830799|NCT02696798|147208257|SUPERIORITY||LS Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.08||0.303|TWO_SIDED|95.0|-3.3|1.0|||Mixed Models Analysis|||||1.0|-3.3|0.303
73830800|NCT02696798|147208258|SUPERIORITY||LS Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.813|TWO_SIDED|95.0|-1.5|1.2|||Mixed Models Analysis|||||1.2|-1.5|0.813
73830801|NCT02696798|147208258|SUPERIORITY||LS Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.71||0.41|TWO_SIDED|95.0|-2.0|0.8|||Mixed Models Analysis|||||0.8|-2.0|0.410
73830802|NCT02696798|147208260|SUPERIORITY||LS Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.9|-0.6|||Mixed Models Analysis|||||-0.6|-1.9|<0.001
73830803|NCT02696798|147208260|SUPERIORITY||LS Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.34||0.005|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|||||-0.3|-1.6|0.005
73830804|NCT02696798|147208261|SUPERIORITY||LS Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.68||0.088|TWO_SIDED|95.0|-2.5|0.2|||Mixed Models Analysis|||||0.2|-2.5|0.088
73830805|NCT02696798|147208261|SUPERIORITY||LS Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.366|TWO_SIDED|95.0|-2.0|0.7|||Mixed Models Analysis|||||0.7|-2.0|0.366
73830806|NCT02696798|147208262|SUPERIORITY||LS Mean Difference (Final Values)|-11.13|STANDARD_ERROR_OF_MEAN|5.323||0.038|TWO_SIDED|95.0|-21.65|-0.6|||ANCOVA|||Overall Work Impairment Score||-0.60|-21.65|0.038
73830807|NCT02696798|147208262|SUPERIORITY||LS Mean Difference (Final Values)|-13.66|STANDARD_ERROR_OF_MEAN|5.341||0.012|TWO_SIDED|95.0|-24.23|-3.1|||ANCOVA|||Overall Work Impairment Score||-3.10|-24.23|0.012
73830808|NCT02696798|147208262|SUPERIORITY||LS Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|3.5||0.071|TWO_SIDED|95.0|-13.2|0.5|||ANCOVA|||Percentage of Activity Impairment||0.5|-13.2|0.071
73830809|NCT02696798|147208262|SUPERIORITY||LS Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|3.65||0.024|TWO_SIDED|95.0|-15.5|-1.1|||ANCOVA|||Percentage of Activity Impairment||-1.1|-15.5|0.024
73830810|NCT03857256|147208287|SUPERIORITY|Mean changes from Week 0 in LDL-C were analyzed using a restricted maximum likelihood (REML)-based repeated measures approach including effects of treatment group, time (Week 6 and Week 12) and treatment group x time interaction as well as the covariates of Week 0 value of LDL-C and Week 0 value of LDL-C x time interaction. An unstructured covariance structure were used to model the within-patient errors. Contrasts under this model allowed for the three main comparisons.||||||0.0167||||||Tests involving the comparisons of each of the active groups versus placebo for the primary endpoint were conducted at the 0.0167 significance level (to account for three main comparisons).|Mixed Models Analysis|The Kenward-Roger approximation were used to estimate denominator degrees of freedom.||Tests involving the comparisons of each of the active groups versus placebo for the primary endpoint were conducted at the 0.0167 significance level (to account for three main comparisons).||||0.0167
73830811|NCT03675308|147208327|SUPERIORITY||Response Rate Difference|24.0|||<|0.001|TWO_SIDED|95.0|18.0|30.0||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of baseline psoriasis (≥ 3%/\< 3% body surface area), presence of dactylitis (yes/no), presence of enthesitis (yes/no) and current csDMARD use (0/≥ 1).||30.0|18.0|<0.001
73830812|NCT03675308|147208328|SUPERIORITY||Least Squares (LS) Mean Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-0.26|-0.14||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.14|-0.26|<0.001
73830813|NCT03675308|147208329|SUPERIORITY||Response Rate Difference|42.5|||<|0.001|TWO_SIDED|95.0|35.6|49.3||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||49.3|35.6|<0.001
73830814|NCT03675308|147208330|SUPERIORITY||Response Rate Difference|23.1|||<|0.001|TWO_SIDED|95.0|16.8|29.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||29.4|16.8|<0.001
73830815|NCT03675308|147208331|SUPERIORITY||Response Rate Difference|14.8|||<|0.001|TWO_SIDED|95.0|10.2|19.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||19.4|10.2|<0.001
73830816|NCT03675308|147208332|SUPERIORITY||LS Mean Difference|-4.19|||<|0.001|TWO_SIDED|95.0|-5.7|-2.68||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-2.68|-5.70|<0.001
73830817|NCT03675308|147208333|SUPERIORITY||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.3|-0.6|<0.001
73830818|NCT03675308|147208334|SUPERIORITY||Response Rate Difference|13.9|||<|0.001|TWO_SIDED|95.0|7.6|20.2||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use and extent of psoriasis at Baseline and study.|Response Rate Difference = Risankizumab - Placebo|The pre-specified analysis for the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).||20.2|7.6|<0.001
73830819|NCT03675308|147208335|SUPERIORITY||Response Rate Difference|16.9|||<|0.001|TWO_SIDED|95.0|7.5|26.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, extent of psoriasis at Baseline, and study.|Response Rate Difference = Risankizumab - Placebo|The pre-specified analysis for the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).||26.4|7.5|<0.001
73830820|NCT03675308|147208336|SUPERIORITY||LS Mean Difference|-0.09||||0.496|TWO_SIDED|95.0|-0.36|0.17||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|ANCOVA|ANCOVA model including treatment and the stratification factors and baseline value as covariates.|Difference = Risankizumab - Placebo|||0.17|-0.36|0.496
73830821|NCT03675308|147208337|OTHER||LS Mean Difference|3.32|||<|0.001|TWO_SIDED|95.0|2.42|4.22||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||4.22|2.42|<0.001
73830822|NCT03675308|147208338|OTHER||LS Mean Difference|2.6|||<|0.001|TWO_SIDED|95.0|1.5|3.7||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||3.7|1.5|<0.001
73830823|NCT03675308|147208339|SUPERIORITY||Response Rate Difference|22.2|||<|0.001|TWO_SIDED|95.0|17.3|27.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||27.2|17.3|<0.001
73830824|NCT03675308|147208340|SUPERIORITY||Response Rate Difference|10.5|||<|0.001|TWO_SIDED|95.0|6.9|14.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||14.2|6.9|<0.001
73830825|NCT05172609|147208364|EQUIVALENCE|Margin difference of 1 standard deviation (SD) or higher was considered evidence of non-equivalence comparison||||||0.47|||||||t-test, 2 sided|||T-tests between EBIS and IAU conditions at 12-week follow up for AIM||||.47
73830826|NCT05172609|147208365|EQUIVALENCE|Margin difference of 1 SD or higher was considered evidence of non-equivalence comparison||||||0.88|||||||t-test, 2 sided|||T-tests between EBIS and IAU conditions at 12-week follow up for FIM||||.88
73830827|NCT05172609|147208366|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS screening rating at Time 3: two weeks after completing the training||||.46
73830828|NCT05172609|147208366|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS screening rating at Time 4: 12 weeks after completing the training||||.40
73830829|NCT05172609|147208366|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 3: two weeks after completing the training||||.56
73830830|NCT05172609|147208366|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 4: 12 weeks after completing the training||||.68
73830831|NCT05172609|147208366|SUPERIORITY|||||||0.87|||||||ANCOVA|||Repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS screening at timepoints 1, 3, and 4||||.87
73830832|NCT05172609|147208366|SUPERIORITY|||||||0.43|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS planning at timepoints 1, 3, and 4||||.43
73830833|NCT05172609|147208367|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening self-efficacy rating at Time 3: two weeks after completing the training||||.59
73830834|NCT05172609|147208367|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening self-efficacy rating at Time 4: 12 weeks after completing the training||||.59
73830835|NCT05172609|147208367|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 3: two weeks after completing the training||||.25
73830836|NCT05172609|147208367|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 4: 12 weeks after completing the training||||.35
73830837|NCT05172609|147208367|SUPERIORITY|||||||0.88|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy screening at timepoints 1, 3, and 4||||.88
73830838|NCT05172609|147208367|SUPERIORITY|||||||0.71|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy intervening at timepoints 1, 3, and 4||||.71
73830839|NCT05172609|147208368|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening use at Time 3: two weeks after completing the training||||.88
73830840|NCT05172609|147208368|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening use at Time 4: 12 weeks after completing the training||||.55
73830841|NCT05172609|147208368|SUPERIORITY|||||||0.36|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: CSR screening at timepoints 1, 3, and 4||||.36
73830842|NCT05172609|147208369|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing total SPIRS score at Time 3: two weeks after completing the training||||.24
73830843|NCT05172609|147208369|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing total SPIRS score at Time 4: 12 weeks after completing the training||||.88
73830844|NCT05172609|147208369|SUPERIORITY|||||||0.1|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: SPIRS at timepoints 3 and 4||||.10
73830845|NCT04476043|147208374|SUPERIORITY||Least squares mean (LSM) difference|-2.7|STANDARD_ERROR_OF_MEAN|1.23||0.0277|TWO_SIDED|95.0|-5.2|-0.3|||MMRM|||||-0.3|-5.2|0.0277
73830846|NCT04476043|147208374|SUPERIORITY||LSM difference|-4.4|STANDARD_ERROR_OF_MEAN|1.25||0.0006|TWO_SIDED|95.0|-6.8|-1.9|||MMRM|||||-1.9|-6.8|0.0006
73830847|NCT04476043|147208374|SUPERIORITY||LSM difference|-3.8|STANDARD_ERROR_OF_MEAN|1.22||0.0021|TWO_SIDED|95.0|-6.2|-1.4|||MMRM|||||-1.4|-6.2|0.0021
73830848|NCT04476043|147208375|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0445|TWO_SIDED|95.0|1.0|5.3|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||5.3|1.0|0.0445
73830849|NCT04476043|147208375|SUPERIORITY||Difference in response rate|19.2|STANDARD_ERROR_OF_MEAN|9.35|||||||||||Standard error of difference between response rates was from normal approximation.|||||
73830850|NCT04476043|147208375|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0998|TWO_SIDED|95.0|0.9|4.6|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||4.6|0.9|0.0998
73830851|NCT04476043|147208375|SUPERIORITY||Difference in response rate|15.4|STANDARD_ERROR_OF_MEAN|9.32|||||||||||Standard error of difference between response rates was from normal approximation.|||||
73830852|NCT04476043|147208375|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0829|TWO_SIDED|95.0|0.9|4.7|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||4.7|0.9|0.0829
73830853|NCT04476043|147208375|SUPERIORITY||Difference in response rate|16.4|STANDARD_ERROR_OF_MEAN|9.29|||||||||||Standard error of difference between response rates was from normal approximation.|||||
73830854|NCT02385318|147208392|EQUIVALENCE|85% power of success|Equivalence ratio|1.11|||||TWO_SIDED|90.0|-4.38|14.44|||Yates correction|||||14.44|-4.38|
73830855|NCT01080261|147208393|NON_INFERIORITY_OR_EQUIVALENCE|Study had 91% statistical power to demonstrate that the 9-month rate for MACE (accounting for an expected 9-month attrition rate of 10%) is less than the performance goal, assuming a 9-month MACE rate of 8.2%.|Percent of patients experiencing a MACE|0.0|||<|0.0001|ONE_SIDED|95.0||4.9|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the percentage of patients experiencing a MACE event (primary endpoint) in the PROMUS Element cohort is less than the predefined performance goal of 24.1% (based on historical outcomes with plain balloon angioplasty \[20.2%\] plus an adjustment of 3.9% for small vessels).||4.9||<0.0001
73830856|NCT02594111|147208405|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
73830857|NCT01126424|147208423|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-20.986||||0.3771|TWO_SIDED|95.0|-68.58|26.607|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||26.607|-68.580|0.3771
73830858|NCT01126424|147208423|SUPERIORITY_OR_OTHER||Least Square Mean Difference|17.508||||0.4487|TWO_SIDED|95.0|-28.854|63.87|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||63.870|-28.854|0.4487
73830859|NCT01126424|147208424|SUPERIORITY_OR_OTHER||Least Square Mean Difference|9.152||||0.0505|TWO_SIDED|95.0|-0.023|18.326|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||18.326|-0.023|0.0505
73830860|NCT01126424|147208424|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.846||||0.6753|TWO_SIDED|95.0|-7.02|10.713|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||10.713|-7.020|0.6753
73830861|NCT01126424|147208425|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.507||||0.5684|TWO_SIDED|95.0|-2.293|1.279|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||1.279|-2.293|0.5684
73830862|NCT01126424|147208425|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.792||||0.2348|TWO_SIDED|95.0|-2.122|0.538|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.538|-2.122|0.2348
73830863|NCT01126424|147208426|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.04||||0.6275|TWO_SIDED|95.0|-0.208|0.127|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.127|-0.208|0.6275
73830864|NCT01126424|147208426|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.046||||0.5361|TWO_SIDED|95.0|-0.194|0.103|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.103|-0.194|0.5361
73830865|NCT01126424|147208427|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.655||||0.6315|TWO_SIDED|95.0|-14.858|24.167|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||24.167|-14.858|0.6315
73830866|NCT01126424|147208427|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.457||||0.867|TWO_SIDED|95.0|-18.976|16.062|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||16.062|-18.976|0.8670
73830867|NCT01126424|147208428|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-77.919||||0.5953|TWO_SIDED|95.0|-372.814|216.976|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||216.976|-372.814|0.5953
73830868|NCT01126424|147208428|SUPERIORITY_OR_OTHER||Least Square Mean Difference|157.783||||0.3526|TWO_SIDED|95.0|-182.015|497.581|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||497.581|-182.015|0.3526
73830869|NCT00248560|147208429|SUPERIORITY_OR_OTHER||Response rate|0.17|||||TWO_SIDED|95.0|0.08|0.32||||||||0.32|0.08|
73830870|NCT01134042|147208441|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.193|||<|0.001|TWO_SIDED|95.0|0.108|0.277|||ANCOVA|||||0.277|0.108|<0.001
73830871|NCT01134042|147208441|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.21|||<|0.001|TWO_SIDED|95.0|0.127|0.294|||ANCOVA|||||0.294|0.127|<0.001
73830872|NCT01134042|147208441|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the confidence interval (CI: 0.025, 1-sided significance level) for the mean difference in change from Baseline in clinic visit trough FEV1 of FF 200 µg OD versus FP 500 µg BID was greater than -125 milliliters.|Median Difference (Final Values)|0.018|||||TWO_SIDED|95.0|-0.066|0.102||||||||0.102|-0.066|
73830873|NCT01134042|147208442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136||||0.048|TWO_SIDED|95.0|0.001|0.27|||ANCOVA|||||0.270|0.001|0.048
73830874|NCT01134042|147208442|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.206||||0.003|TWO_SIDED|95.0|0.073|0.339|||ANCOVA|||||0.339|0.073|0.003
73830875|NCT02328105|147208452|SUPERIORITY|Assuming the true overall response rate is 0.20 under the null hypothesis, then this design will provide 81% power to detect a difference of 0.15 under the alternative hypothesis, assuming a one-sided alpha = 0.09 significance level. A three stage design with n=15, 30 and 45 subjects was determined with the following rejection regions: For n = 15, the rejection region in number of responses (CR or PR) is 0 - 2, for n = 30 it is 3 - 6, and for n = 45 it is 7 - 12.|Response Rate|0.364||||0.161|TWO_SIDED|95.0|0.109|0.692||This p-value is only based on partial enrollment of stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|||0.692|0.109|0.161
73830876|NCT02328105|147208453|OTHER|Estimation only.|Disease Control Rate|0.818|||||TWO_SIDED|95.0|0.482|0.977|||||Confidence interval estimated using the Clopper Pearson method.|||0.977|0.482|
73830877|NCT02328105|147208454|OTHER|Estimation only.|Median|7.3|||||TWO_SIDED|95.0|2.2|13.0|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||13.0|2.2|
73830878|NCT02328105|147208455|OTHER|Estimation only.|Median|30.0|||||TWO_SIDED|95.0|2.2||Upper limit of the confidence interval is not reached due to censoring rate.||||The Kaplan Meier method was used to estimate median OS(in months). The Greenwood method was used to estimate confidence limits of median overall survival.||||2.2|
73830879|NCT02328105|147208456|OTHER|Estimation only.|Median|10.8|||||TWO_SIDED|95.0|4.9|11.9|||||The Kaplan Meier method was used to estimate median duration of response (in months). The Greenwood method was used to estimate confidence limits of median duration of response.|||11.9|4.9|
73830880|NCT02328105|147208457|OTHER|Estimation only.|Median|7.3|||||TWO_SIDED|95.0|3.0|13.0|||||The Kaplan Meier method was used to estimate median duration of disease control (in months). The Greenwood method was used to estimate confidence limits of median disease control duration.|||13.0|3.0|
73830881|NCT01588509|147208460|SUPERIORITY||Percent Change from Baseline|2.13||||0.002|TWO_SIDED|90.0|1.05|3.2|||ANOVA|||||3.20|1.05|0.002
73830882|NCT01588509|147208460|SUPERIORITY||Percent Change from Baseline|2.08||||0.002|TWO_SIDED|90.0|1.02|3.14|||ANOVA|||||3.14|1.02|0.002
73830883|NCT01588509|147208461|SUPERIORITY||Percent Change from Baseline|2.06|||<|0.001|TWO_SIDED|90.0|1.07|3.05|||ANOVA|||||3.05|1.07|<0.001
73830884|NCT01588509|147208461|SUPERIORITY||Percent Change from Baseline|1.92||||0.002|TWO_SIDED|90.0|0.95|2.89|||ANOVA|||||2.89|0.95|0.002
73830885|NCT01588509|147208462|SUPERIORITY||Percent Change from Baseline|1.38|||<|0.001|TWO_SIDED|90.0|0.81|1.95|||ANOVA|||||1.95|0.81|<0.001
73830886|NCT01588509|147208462|SUPERIORITY||Percent Change from Baseline|1.4|||<|0.001|TWO_SIDED|90.0|0.84|1.96|||ANOVA|||||1.96|0.84|<0.001
73830887|NCT00393367|147208472|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||The difference in median improvement between treatment groups was expected to be greater than 2.|Wilcoxon (Mann-Whitney)|||||||0.44
73830888|NCT00393367|147208473|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.97|TWO_SIDED|95.0|-0.14|0.14|||Chi-squared|||||0.14|-0.14|0.97
73830889|NCT00393367|147208474|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-7.0|6.0|||t-test, 2 sided|||||6|-7|
73830890|NCT00393367|147208475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|95.0|-3.0|3.0|||t-test, 2 sided|||||3|-3|
73830891|NCT00393367|147208476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||||1|-1|
73830892|NCT00393367|147208477|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03||||0.69||95.0|-0.2|0.14|||Chi-squared|||||0.14|-0.20|0.69
73830893|NCT00393367|147208478|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.22||||0.08|TWO_SIDED|95.0|-0.02|0.47|||Chi-squared|||||0.47|-0.02|0.08
73830894|NCT00393367|147208479|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14||||0.22|TWO_SIDED|95.0|-0.37|0.08|||Chi-squared|||||0.08|-0.37|0.22
73830895|NCT00393367|147208481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.36||0.78|TWO_SIDED|95.0|-0.6|0.8|||t-test, 2 sided|||||0.8|-0.6|0.78
73830896|NCT03286504|147208484|SUPERIORITY||proportion difference|0.05||||0.55|TWO_SIDED|95.0|-0.112|0.212|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.212|-0.112|0.55
73830897|NCT03286504|147208485|SUPERIORITY||proportion difference|0.033||||0.71|TWO_SIDED|95.0|-0.145|0.211|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.211|-0.145|0.71
73830898|NCT03286504|147208487|SUPERIORITY||proportion difference|-0.05||||0.65|TWO_SIDED|95.0|-0.269|0.169|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.169|-0.269|0.65
73830899|NCT03286504|147208488|SUPERIORITY||proportion difference|0.226||||0.04|TWO_SIDED|95.0|0.015|0.438|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.438|0.015|0.04
73830900|NCT03286504|147208489|SUPERIORITY||proportion difference|0.208||||0.03|TWO_SIDED|95.0|0.023|0.393|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm.|||0.393|0.023|0.03
73830901|NCT02030600|147208518|SUPERIORITY_OR_OTHER||Treatment ratio|0.7|||<|0.0001|TWO_SIDED|95.0|0.61|0.8|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period"||0.80|0.61|<0.0001
73830902|NCT02030600|147208519|SUPERIORITY_OR_OTHER||Treatment ratio|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.74|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period."||0.74|0.46|<0.0001
73830903|NCT02030600|147208520|SUPERIORITY_OR_OTHER|||||||0.3458||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||"Stepwise hierarchical testing procedure:~Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes in the maintenance period."||||0.3458
73830904|NCT02030600|147208522|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of IDeg against IGlar was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%.|Treatment contrast|0.09|||||TWO_SIDED|95.0|-0.04|0.23||||||"Change from baseline in HbA1c at week 32 (treatment period 1). Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a mixed model for repeated measurement (MMRM) with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates."||0.23|-0.04|
73830905|NCT02030600|147208522|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%|Treatment contrast|0.06|||||TWO_SIDED|95.0|-0.07|0.18||||||"Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a MMRM with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates."||0.18|-0.07|
73830906|NCT01155323|147208524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.21|0.23|||Mixed Models Analysis||Mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be superior to omafilcon A for comfort.||0.23|-0.21|
73830907|NCT01155323|147208525|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.19|0.25|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for vision.||0.25|-0.19|
73830908|NCT01155323|147208526|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.22|0.22|||||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for lens handling.||0.22|-0.22|
73830909|NCT01155323|147208527|NON_INFERIORITY_OR_EQUIVALENCE|Margin = +/-0.50|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A for corneal staining.||0.01|-0.03|
73830910|NCT01155323|147208528|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.15|0.29|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for quality perceptions.||0.29|-0.15|
73830911|NCT01155323|147208529|NON_INFERIORITY_OR_EQUIVALENCE|Margin = +/- 0.50|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A from limbal hyperemia.||0.06|-0.01|
73830912|NCT02471339|147208533|SUPERIORITY|||||||0.05|||||||ANCOVA|||Analysis of covariance. Analyses for primary and secondary outcomes were two-tailed and alpha was set to 0.05. An a priori analysis suggested that, to detect a change of .68 standard deviation on the primary outcome measure between the two groups at .80 power, 41 patients per group would be needed.||||0.05
73830913|NCT02471339|147208534|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
73830914|NCT02471339|147208537|SUPERIORITY|||||||0.05|||||||t-test|||||||.05
73830915|NCT02471339|147208541|SUPERIORITY|||||||0.042|||||||ANOVA|||||||0.042
73830916|NCT00303186|147208583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_DEVIATION|7.03|<|0.0001|TWO_SIDED|95.0|2.4|5.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||5.10|2.40|<0.0001
73830917|NCT00303186|147208583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.72|STANDARD_DEVIATION|7.47|<|0.001|TWO_SIDED|95.0|1.65|5.78|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||5.78|1.65|<0.001
73830918|NCT00303186|147208583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_DEVIATION|4.1||0.518|TWO_SIDED|95.0|-1.5|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.76|-1.50|0.518
73830919|NCT00303186|147208584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.72|STANDARD_DEVIATION|27.89|<|0.0001|TWO_SIDED|95.0|12.38|23.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||23.07|12.38|<0.0001
73830920|NCT00303186|147208584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_DEVIATION|20.36|<|0.0001|TWO_SIDED|95.0|6.99|18.21|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||18.21|6.99|<0.0001
73830921|NCT00303186|147208584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_DEVIATION|18.7||0.833|TWO_SIDED|95.0|-5.7|4.61|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||4.61|-5.70|0.833
73830922|NCT00303186|147208585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|STANDARD_DEVIATION|2.39|<|0.0001|TWO_SIDED|95.0|2.26|3.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||3.18|2.26|<0.0001
73830923|NCT00303186|147208585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|2.36|<|0.0001|TWO_SIDED|95.0|1.59|2.87|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.87|1.59|<0.0001
73830924|NCT00303186|147208585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_DEVIATION|2.03||0.309|TWO_SIDED|95.0|-0.83|0.27|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.27|-0.83|0.309
73830925|NCT00303186|147208587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_DEVIATION|11.75||0.004|TWO_SIDED|95.0|1.619|8.301|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||8.301|1.619|0.004
73830926|NCT00303186|147208588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.76|STANDARD_DEVIATION|18.8||0.015|TWO_SIDED|95.0|-12.155|-1.355|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-1.355|-12.155|0.015
73830927|NCT00303186|147208589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|7.41||0.676|TWO_SIDED|95.0|-1.666|2.546|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.546|-1.666|0.676
73830928|NCT00303186|147208590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.486|STANDARD_DEVIATION|2.96|<|0.0001|TWO_SIDED|95.0|0.918|2.05|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||2.05|0.918|<0.0001
73830929|NCT00303186|147208590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|3.64|<|0.001|TWO_SIDED|95.0|1.01|2.99|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.99|1.01|<0.001
73830930|NCT00303186|147208590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|3.32||0.223|TWO_SIDED|95.0|-0.35|1.46|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||1.46|-0.35|0.223
73830931|NCT00303186|147208591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|STANDARD_DEVIATION|5.94|<|0.0001|TWO_SIDED|95.0|5.1|7.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 12: swollen joints.||7.47|5.10|<0.0001
73830932|NCT00303186|147208591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_DEVIATION|6.35|<|0.0001|TWO_SIDED|95.0|4.48|7.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 60: swollen joints.||7.92|4.48|<0.0001
73830933|NCT00303186|147208591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|2.09||0.479|TWO_SIDED|95.0|-0.36|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: swollen joints and Month 60: swollen joints.||0.76|-0.36|0.479
73830934|NCT00303186|147208591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.0|STANDARD_DEVIATION|11.16|<|0.0001|TWO_SIDED|95.0|6.86|11.13|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 12: tender joints.||11.13|6.86|<0.0001
73830935|NCT00303186|147208591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_DEVIATION|9.25|<|0.0001|TWO_SIDED|95.0|6.1|11.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 60: tender joints.||11.10|6.10|<0.0001
73830936|NCT00303186|147208591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|8.92||0.588|TWO_SIDED|95.0|-1.76|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: tender joints and Month 60: tender joints.||3.07|-1.76|0.588
73830937|NCT00303186|147208595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|11.29||0.33|TWO_SIDED|95.0|-1.3|3.82|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||3.82|-1.30|0.330
73830938|NCT00303186|147208595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.56|STANDARD_DEVIATION|32.28||0.449|TWO_SIDED|95.0|-33.37|16.26|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||16.26|-33.37|0.449
73830939|NCT00303186|147208595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|38.17||0.165|TWO_SIDED|95.0|-37.04|7.04|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||7.04|-37.04|0.165
73830940|NCT00303186|147208596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.18|STANDARD_DEVIATION|24.48|<|0.0001|TWO_SIDED|95.0|26.44|35.91|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||35.91|26.44|<0.0001
73830941|NCT00303186|147208596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.76|STANDARD_DEVIATION|23.24|<|0.0001|TWO_SIDED|95.0|22.42|35.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||35.10|22.42|<0.0001
73830942|NCT00303186|147208596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05|STANDARD_DEVIATION|24.6||0.538|TWO_SIDED|95.0|-8.7|4.6|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||4.60|-8.70|0.538
73830943|NCT00303186|147208597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.83|STANDARD_DEVIATION|19.6|<|0.0001|TWO_SIDED|95.0|30.04|37.63|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||37.63|30.04|<0.0001
73830944|NCT00303186|147208597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.04|STANDARD_DEVIATION|21.17|<|0.0001|TWO_SIDED|95.0|31.96|44.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||44.12|31.96|<0.0001
73830945|NCT00303186|147208597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38|STANDARD_DEVIATION|17.59||0.343|TWO_SIDED|95.0|-2.62|7.38|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||7.38|-2.62|0.343
73830946|NCT00303186|147208598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.18|STANDARD_DEVIATION|27.56|<|0.0001|TWO_SIDED|95.0|25.88|36.49|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||36.49|25.88|<0.0001
73830947|NCT00303186|147208598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.8|STANDARD_DEVIATION|25.89|<|0.0001|TWO_SIDED|95.0|21.52|36.09|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||36.09|21.52|<0.0001
73830948|NCT00303186|147208598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|STANDARD_DEVIATION|22.77||0.301|TWO_SIDED|95.0|-9.74|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||3.07|-9.74|0.301
73830949|NCT00303186|147208599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.21|STANDARD_DEVIATION|123.2|<|0.0001|TWO_SIDED|95.0|2.01|50.4|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.||50.40|2.01|<0.0001
73830950|NCT00303186|147208599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.19|STANDARD_DEVIATION|18.3|<|0.0001|TWO_SIDED|95.0|7.81|18.57|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.||18.57|7.81|<0.0001
73830951|NCT00303186|147208599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31|STANDARD_DEVIATION|14.07||0.132|TWO_SIDED|95.0|-6.4|1.77|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.||1.77|-6.40|0.132
73830952|NCT00303186|147208600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.26|STANDARD_DEVIATION|150.1|<|0.0005|TWO_SIDED|95.0|-13.52|46.04|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.||46.04|-13.52|<0.0005
73830953|NCT00303186|147208600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.81|STANDARD_DEVIATION|100.25|<|0.0001|TWO_SIDED|95.0|22.33|83.29|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.||83.29|22.33|<0.0001
73830954|NCT00303186|147208600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.4|STANDARD_DEVIATION|147.25||0.034|TWO_SIDED|95.0|-10.84|77.64|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.||77.64|-10.84|0.034
73830955|NCT00303186|147208602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_DEVIATION|0.66|<|0.0001|TWO_SIDED|95.0|0.35|0.62|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||0.62|0.35|<0.0001
73830956|NCT00303186|147208602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_DEVIATION|0.56|<|0.0001|TWO_SIDED|95.0|0.26|0.56|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||0.56|0.26|<0.0001
73830957|NCT00303186|147208602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.61||0.6|TWO_SIDED|95.0|-0.24|0.14|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.14|-0.24|0.600
73830958|NCT00303186|147208603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.31|<|0.0001|TWO_SIDED|95.0|0.18|0.3|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||0.30|0.18|<0.0001
73830959|NCT00303186|147208603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_DEVIATION|0.34|<|0.0001|TWO_SIDED|95.0|-0.31|-0.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-0.12|-0.31|<0.0001
73830960|NCT00303186|147208603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.27||0.789|TWO_SIDED|95.0|-0.08|0.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.06|-0.08|0.789
73830961|NCT00303186|147208604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.4|STANDARD_DEVIATION|25.0|<|0.0001|TWO_SIDED|95.0|14.59|24.22|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||24.22|14.59|<0.0001
73830962|NCT00303186|147208604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|STANDARD_DEVIATION|22.08||0.0001|TWO_SIDED|95.0|-18.77|-6.59|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-6.59|-18.77|0.0001
73830963|NCT00303186|147208604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.85|STANDARD_DEVIATION|22.22||0.115|TWO_SIDED|95.0|-1.21|10.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||10.92|-1.21|0.115
73830964|NCT00303186|147208605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|STANDARD_DEVIATION|10.1|<|0.0001|TWO_SIDED|95.0|-10.34|-4.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 12: physical component score.||-4.47|-10.34|<0.0001
73830965|NCT00303186|147208605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94|STANDARD_DEVIATION|9.13|<|0.0001|TWO_SIDED|95.0|-8.56|-3.32|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 60: physical component score.||-3.32|-8.56|<0.0001
73830966|NCT00303186|147208605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|STANDARD_DEVIATION|8.83||0.308|TWO_SIDED|95.0|-1.19|3.68|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: physical component score and Month 60: physical component score.||3.68|-1.19|0.308
73830967|NCT00303186|147208605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_DEVIATION|8.51||0.589|TWO_SIDED|95.0|-3.14|1.8|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 12: mental component score.||1.80|-3.14|0.589
73830968|NCT00303186|147208605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.59|STANDARD_DEVIATION|12.29||0.003|TWO_SIDED|95.0|-9.12|-2.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 60: mental component score.||-2.06|-9.12|0.003
73830969|NCT00303186|147208605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_DEVIATION|12.8||0.002|TWO_SIDED|95.0|-9.23|-2.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: mental component score and Month 60: mental component score.||-2.18|-9.23|0.002
73830970|NCT00460798|147208625|SUPERIORITY_OR_OTHER||Obective Response Rate (Percent)|40.6|||||TWO_SIDED|95.0|35.5|46.0|||||Exact method based on binomial distribution|Objective Response Rate (ORR) = Percentage of participants with best overall response of CR or PR||46.0|35.5|
73830971|NCT02320396|147208642|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.14|-0.51|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in TNSS was estimated using a constrained longitudinal data analysis (cLDA) model, where both BL and post-BL measurements (average score of 2 weeks) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.||-0.51|-1.14|<0.001
73830972|NCT02320396|147208645|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.82|||<|0.001|TWO_SIDED|95.0|-1.14|-0.5|||cLDA model|||"Change from BL in TNSS at Week 1: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in TNSS was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.50|-1.14|<0.001
73830973|NCT02320396|147208645|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.84|||<|0.001|TWO_SIDED|95.0|-1.23|-0.46|||cLDA model|||"Change from BL in TNSS at Week 2: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in TNSS was estimated using a cLDA model, where both BL and post- BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.46|-1.23|<0.001
73830974|NCT02320396|147208646|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL to Week 1 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
73830975|NCT02320396|147208646|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21|||<|0.001|TWO_SIDED|95.0|-0.32|-0.1|||cLDA model|||"Change from BL to Week 1 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.10|-0.32|<0.001
73830976|NCT02320396|147208646|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.008|TWO_SIDED|95.0|-0.16|-0.02|||cLDA model|||"Change from BL to Week 1 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.02|-0.16|0.008
73830977|NCT02320396|147208646|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.27|||<|0.001|TWO_SIDED|95.0|-0.38|-0.15|||cLDA model|||"Change from BL to Week 1 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.38|<0.001
73830978|NCT02320396|147208647|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.36|-0.13|||cLDA model|||"Change from BL to Week 2 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.13|-0.36|<0.001
73830979|NCT02320396|147208647|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
73830980|NCT02320396|147208647|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.037|TWO_SIDED|95.0|-0.18|-0.01|||cLDA model|||"Change from BL to Week 2 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.01|-0.18|0.037
73830981|NCT02320396|147208647|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.26|||<|0.001|TWO_SIDED|95.0|-0.4|-0.12|||cLDA model|||"Change from BL to Week 2 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.40|<0.001
73830982|NCT02320396|147208648|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Sneezing During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
73830983|NCT02320396|147208648|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.23|||<|0.001|TWO_SIDED|95.0|-0.33|-0.12|||cLDA model|||"Change from BL in Rhinorrhea During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.33|<0.001
73830984|NCT02320396|147208648|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.009|TWO_SIDED|95.0|-0.16|-0.02|||cLDA model|||"Change from BL in Nasal Congestion During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.02|-0.16|0.009
73830985|NCT02320396|147208648|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.26|||<|0.001|TWO_SIDED|95.0|-0.38|-0.15|||cLDA model|||"Change from BL in Nasal Itching During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.~cLDA model"||-0.15|-0.38|<0.001
73830986|NCT02320396|147208649|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.35|<0.001
73830987|NCT02320396|147208649|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16|||<|0.001|TWO_SIDED|95.0|-0.24|-0.08|||cLDA model|||"Change from BL to Week 1 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.08|-0.24|<0.001
73830988|NCT02320396|147208649|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.35|<0.001
73830989|NCT02320396|147208650|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
73830990|NCT02320396|147208650|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.13||||0.01|TWO_SIDED|95.0|-0.24|-0.03|||cLDA model|||"Change from BL to Week 2 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.03|-0.24|0.010
73830991|NCT02320396|147208650|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.24|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
73830992|NCT02320396|147208651|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Eye Pruritus During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
73830993|NCT02320396|147208651|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.15|||<|0.001|TWO_SIDED|95.0|-0.23|-0.07|||cLDA model|||"Change from BL in Watering Eyes During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.07|-0.23|<0.001
73830994|NCT02320396|147208651|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in the worse of Pruritus or Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value||-0.15|-0.35|<0.001
73830995|NCT02320396|147208652|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16|||<|0.001|TWO_SIDED|95.0|-0.24|-0.07|||cLDA model|||"Change from BL to Week 1 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.07|-0.24|<0.001
73830996|NCT02320396|147208652|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.19|||<|0.001|TWO_SIDED|95.0|-0.3|-0.09|||cLDA model|||"Change from BL to Week 2 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.09|-0.30|<0.001
73830997|NCT02320396|147208652|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.17|||<|0.001|TWO_SIDED|95.0|-0.26|-0.08|||cLDA model|||"Change from BL in Interference with Daily Activities During 2 Wks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Interference with Daily Activities estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo evaluated with the 95% confidence interval and P-value."||-0.08|-0.26|<0.001
73830998|NCT02320396|147208653|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.492||||0.071|TWO_SIDED|95.0|0.966|2.303|||Regression, Logistic|||"Impression Rate as Assessed by Investigator: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of Better + Much better) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of \>1 indicated that desloratadine 5mg was more effective than placebo."||2.303|0.966|0.071
73830999|NCT02320396|147208654|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.149|||<|0.001|TWO_SIDED|95.0|1.408|3.28|||Regression, Logistic|||"Impression Rate as Assessed by Participant: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of Better + Much better) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of \>1 indicated that desloratadine 5mg was more effective than placebo"||3.280|1.408|<0.001
73831000|NCT04666298|147208658|SUPERIORITY||Mean Difference (Net)|-56.6|STANDARD_ERROR_OF_MEAN|3.24|<|0.0001|TWO_SIDED|95.0|-64.2|-49.0||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-49.0|-64.2|<.0001
73831001|NCT04666298|147208658|SUPERIORITY||Mean Difference (Net)|-60.9|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|TWO_SIDED|95.0|-67.6|-54.3||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-54.3|-67.6|<.0001
73831002|NCT04666298|147208658|SUPERIORITY||Mean Difference (Net)|-65.3|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|95.0|-72.0|-58.6||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-58.6|-72.0|<.0001
73831003|NCT00844519|147208675|SUPERIORITY_OR_OTHER|||||||0.17||||||significant at p\<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD||||0.17
73831004|NCT00844519|147208675|SUPERIORITY_OR_OTHER|||||||0.9||||||significant at p\<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD||||0.90
73831005|NCT01311661|147208680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.152|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.229|0.152|<0.0001
73831006|NCT01311661|147208680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.111|0.189|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.189|0.111|<0.0001
73831007|NCT01311661|147208680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.19|0.266|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.266|0.190|<0.0001
73831008|NCT01311661|147208680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.17|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.247|0.170|<0.0001
73831009|NCT01311661|147208681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.15|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.229|0.150|<0.0001
73831010|NCT01311661|147208681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.121|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.199|0.121|<0.0001
73831011|NCT01311661|147208681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.175|0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.253|0.175|<0.0001
73831012|NCT01311661|147208681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.181|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.258|0.181|<0.0001
73831013|NCT01311661|147208682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.153|0.238|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.238|0.153|<0.0001
73831014|NCT01311661|147208682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.102|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.187|0.102|<0.0001
73831015|NCT01311661|147208682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.2|0.285|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.285|0.200|<0.0001
73831016|NCT01311661|147208682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.156|0.241|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.241|0.156|<0.0001
73831017|NCT01311661|147208683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.138|0.228|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.228|0.138|<0.0001
73831018|NCT01311661|147208683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.108|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.198|0.108|<0.0001
73831019|NCT01311661|147208683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.222|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.177|0.267|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.267|0.177|<0.0001
73831020|NCT01311661|147208683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.165|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.255|0.165|<0.0001
73831021|NCT01311661|147208684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.109|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.203|0.109|<0.0001
73831022|NCT01311661|147208684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.054|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.148|0.054|<0.0001
73831023|NCT01311661|147208684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.149|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.243|0.149|<0.0001
73831024|NCT01311661|147208684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.125|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.219|0.125|<0.0001
73831025|NCT01311661|147208685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.091|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.180|0.091|<0.0001
73831026|NCT01311661|147208685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.078|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.167|0.078|<0.0001
73831027|NCT01311661|147208685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.186|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.186|0.098|<0.0001
73831028|NCT01311661|147208685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.103|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.191|0.103|<0.0001
73831029|NCT01311661|147208686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.11|0.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.206|0.110|<0.0001
73831030|NCT01311661|147208686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.09|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.185|0.090|<0.0001
73831031|NCT01311661|147208686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.123|0.218|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.218|0.123|<0.0001
73831032|NCT01311661|147208686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.087|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.182|0.087|<0.0001
73831033|NCT01311661|147208687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.102|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.188|0.102|<0.0001
73831034|NCT01311661|147208687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.085|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.171|0.085|<0.0001
73831035|NCT01311661|147208687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.113|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.198|0.113|<0.0001
73831036|NCT01311661|147208687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.182|0.098|<0.0001
73831037|NCT01311661|147208688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.084|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.187|0.084|<0.0001
73831038|NCT01311661|147208688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.073|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.073|<0.0001
73831039|NCT01311661|147208688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.093|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.195|0.093|<0.0001
73831040|NCT01311661|147208688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.075|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.177|0.075|<0.0001
73831041|NCT01311661|147208689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.028||0.0001||95.0|0.055|0.165|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.165|0.055|0.0001
73831042|NCT01311661|147208689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.028||0.001||95.0|0.037|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.147|0.037|0.0010
73831043|NCT01311661|147208689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.063|0.172|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.172|0.063|<0.0001
73831044|NCT01311661|147208689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.057|0.166|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.166|0.057|<0.0001
73831045|NCT01311661|147208690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.629|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.5|0.757|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.757|0.500|<0.0001
73831046|NCT01311661|147208690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.601|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.473|0.73|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.730|0.473|<0.0001
73831047|NCT01311661|147208690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.631|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.503|0.758|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.758|0.503|<0.0001
73831048|NCT01311661|147208690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.685|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.558|0.813|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.813|0.558|<0.0001
73831049|NCT01311661|147208691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.665|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.532|0.799|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.799|0.532|<0.0001
73831050|NCT01311661|147208691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.564|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.431|0.698|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.698|0.431|<0.0001
73831051|NCT01311661|147208691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.702|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.569|0.835|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.835|0.569|<0.0001
73831052|NCT01311661|147208691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.599|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.467|0.732|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.732|0.467|<0.0001
73831053|NCT01311661|147208692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.641|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.516|0.765|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.765|0.516|<0.0001
73831054|NCT01311661|147208692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.577|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.453|0.701|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.701|0.453|<0.0001
73831055|NCT01311661|147208692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.667|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.544|0.79|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.790|0.544|<0.0001
73831056|NCT01311661|147208692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.643|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.519|0.766|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.766|0.519|<0.0001
73831057|NCT01311661|147208693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.591|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.436|0.746|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.746|0.436|<0.0001
73831058|NCT01311661|147208693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.522|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.366|0.677|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.677|0.366|<0.0001
73831059|NCT01311661|147208693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.594|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.439|0.749|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.749|0.439|<0.0001
73831060|NCT01311661|147208693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.623|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.468|0.777|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.777|0.468|<0.0001
73831061|NCT01311661|147208694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.529|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.396|0.662|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.662|0.396|<0.0001
73831062|NCT01311661|147208694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.277|0.543|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.543|0.277|<0.0001
73831063|NCT01311661|147208694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.603|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.471|0.736|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.736|0.471|<0.0001
73831064|NCT01311661|147208694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.481|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.349|0.613|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.613|0.349|<0.0001
73831065|NCT01311661|147208695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.957|STANDARD_ERROR_OF_MEAN|3.18|<|0.0001||95.0|26.709|39.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||39.206|26.709|<0.0001
73831066|NCT01311661|147208695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.632|STANDARD_ERROR_OF_MEAN|3.167|<|0.0001||95.0|26.409|38.855|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||38.855|26.409|<0.0001
73831067|NCT01311661|147208695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.66|STANDARD_ERROR_OF_MEAN|3.161|<|0.0001||95.0|25.448|37.872|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||37.872|25.448|<0.0001
73831068|NCT01311661|147208695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.895|STANDARD_ERROR_OF_MEAN|3.161|<|0.0001||95.0|22.683|35.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||35.107|22.683|<0.0001
73831069|NCT01311661|147208696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.87|STANDARD_ERROR_OF_MEAN|3.046|<|0.0001||95.0|22.884|34.856|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||34.856|22.884|<0.0001
73831070|NCT01311661|147208696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.056|STANDARD_ERROR_OF_MEAN|3.034|<|0.0001||95.0|26.094|38.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||38.018|26.094|<0.0001
73831071|NCT01311661|147208696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.816|STANDARD_ERROR_OF_MEAN|3.028|<|0.0001||95.0|25.864|37.767|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||37.767|25.864|<0.0001
73831072|NCT01311661|147208696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.327|STANDARD_ERROR_OF_MEAN|3.028|<|0.0001||95.0|27.375|39.278|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||39.278|27.375|<0.0001
73831073|NCT01311661|147208697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.581|STANDARD_ERROR_OF_MEAN|0.346|<|0.0001||95.0|-2.262|-0.9|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.900|-2.262|<0.0001
73831074|NCT01311661|147208697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.345|<|0.0001||95.0|-2.104|-0.748|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.748|-2.104|<0.0001
73831075|NCT01311661|147208697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.738|STANDARD_ERROR_OF_MEAN|0.344|<|0.0001||95.0|-2.415|-1.062|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-1.062|-2.415|<0.0001
73831076|NCT01311661|147208697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.689|STANDARD_ERROR_OF_MEAN|0.344||0.0458||95.0|-1.366|-0.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.013|-1.366|0.0458
73831077|NCT01311661|147208698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|173.391|STANDARD_ERROR_OF_MEAN|19.484|<|0.0001||95.0|135.099|211.682|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||211.682|135.099|<0.0001
73831078|NCT01311661|147208698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|155.097|STANDARD_ERROR_OF_MEAN|19.406|<|0.0001||95.0|116.961|193.234|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||193.234|116.961|<0.0001
73831079|NCT01311661|147208698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|149.268|STANDARD_ERROR_OF_MEAN|19.369|<|0.0001||95.0|111.204|187.333|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||187.333|111.204|<0.0001
73831080|NCT01311661|147208698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|150.441|STANDARD_ERROR_OF_MEAN|19.369|<|0.0001||95.0|112.377|188.505|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||188.505|112.377|<0.0001
73831081|NCT01311661|147208699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.251|STANDARD_ERROR_OF_MEAN|18.997|<|0.0001||95.0|104.916|179.586|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||179.586|104.916|<0.0001
73831082|NCT01311661|147208699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|132.138|STANDARD_ERROR_OF_MEAN|18.92|<|0.0001||95.0|94.954|169.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||169.322|94.954|<0.0001
73831083|NCT01311661|147208699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.136|STANDARD_ERROR_OF_MEAN|18.885|<|0.0001||95.0|105.021|179.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||179.251|105.021|<0.0001
73831084|NCT01311661|147208699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|157.306|STANDARD_ERROR_OF_MEAN|18.885|<|0.0001||95.0|120.192|194.42|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||194.420|120.192|<0.0001
73831085|NCT01311661|147208700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.554|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001||95.0|-0.78|-0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.329|-0.780|<0.0001
73831086|NCT01311661|147208700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.637|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.862|-0.412|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.412|-0.862|<0.0001
73831087|NCT01311661|147208700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.588|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.813|-0.364|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-0.364|-0.813|<0.0001
73831088|NCT01311661|147208700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.546|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.77|-0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.322|-0.770|<0.0001
73831089|NCT01311661|147208705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.461|-0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.253|-0.461|<0.0001
73831090|NCT01311661|147208705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.4|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.192|-0.400|<0.0001
73831091|NCT01311661|147208705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-0.198|-0.405|<0.0001
73831092|NCT01311661|147208705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.302|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.198|-0.405|<0.0001
73831093|NCT01719653|147208750|OTHER||||||<|0.005||||||Chicago BPS Total Score -- 1 was lower than 3,4,5; 2 was lower than 5. Modified Chicago BPS Total Score -- 1 were lower than 5. Chicago BPS Fluid Score -- 1 was dryer than 3,4,5; 2 was dryer than 3,4,5; 3 was wetter than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"||||<0.005
73831094|NCT01719653|147208751|OTHER||||||<|0.001||||||1 was lower than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"||||<0.001
73831095|NCT01719653|147208752|OTHER||||||>|0.005|||||||Chi-squared|||All 5 arms were compared pair-wise.||||>0.005
73831096|NCT02164916|147208768|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.001|TWO_SIDED|95.0|0.31|0.75|||Log Rank|||||0.75|0.31|0.001
73831097|NCT03454555|147208814|SUPERIORITY||Mean Difference (Final Values)|-5.6||||0.31|TWO_SIDED|95.0|-16.6|5.3|||Mixed Models Analysis|||||5.3|-16.6|0.31
73831098|NCT03454555|147208815|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.963|TWO_SIDED|95.0|-10.3|10.7|||Mixed Models Analysis|||||10.7|-10.3|0.963
73831099|NCT03454555|147208816|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.253|TWO_SIDED|95.0|-16.8|4.4|||Mixed Models Analysis|||||4.4|-16.8|0.253
73831100|NCT03454555|147208817|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.9|TWO_SIDED|95.0|-10.1|11.5|||Mixed Models Analysis|||||11.5|-10.1|0.90
73831101|NCT03454555|147208818|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.65|TWO_SIDED|95.0|-13.7|8.6|||Mixed Models Analysis|||||8.6|-13.7|0.65
73831102|NCT03454555|147208819|SUPERIORITY||Mean Difference (Final Values)|9.4||||0.102|TWO_SIDED|95.0|-1.9|20.8|||Mixed Models Analysis|||||20.8|-1.9|0.102
73831103|NCT03454555|147208820|SUPERIORITY||Odds Ratio (OR)|0.93||||0.83|TWO_SIDED|95.0|0.5|1.75|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.75|0.50|0.83
73831104|NCT03454555|147208821|SUPERIORITY||Odds Ratio (OR)|0.79||||0.47|TWO_SIDED|95.0|0.42|1.5|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.50|0.42|0.47
73831105|NCT03454555|147208822|SUPERIORITY||Odds Ratio (OR)|1.02||||0.96|TWO_SIDED|95.0|0.54|1.9|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.90|0.54|0.96
73831106|NCT03454555|147208823|SUPERIORITY||Odds Ratio (OR)|0.71||||0.28|TWO_SIDED|95.0|0.38|1.33|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.33|0.38|0.28
73831107|NCT03454555|147208824|SUPERIORITY||Odds Ratio (OR)|0.9||||0.75|TWO_SIDED|95.0|0.47|1.71|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.71|0.47|0.75
73831108|NCT03454555|147208825|SUPERIORITY||Odds Ratio (OR)|0.68||||0.25|TWO_SIDED|95.0|0.35|1.31|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.31|0.35|0.25
73831109|NCT03454555|147208826|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.7|TWO_SIDED|95.0|-0.9|1.4|||Mixed Models Analysis|||||1.4|-0.9|0.70
73831110|NCT03454555|147208827|SUPERIORITY||Median Difference (Final Values)|0.1||||0.92|TWO_SIDED|95.0|-1.1|1.2|||Mixed Models Analysis|||||1.2|-1.1|0.92
73831111|NCT03454555|147208828|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.64|TWO_SIDED|95.0|-0.7|1.2|||Mixed Models Analysis|||||1.2|-0.7|0.64
73831112|NCT03454555|147208829|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.75|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|0.75
73831113|NCT03454555|147208830|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.69|TWO_SIDED|95.0|-0.9|1.4|||Mixed Models Analysis|||||1.4|-0.9|0.69
73831114|NCT03454555|147208831|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.33|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||||1.8|-0.6|0.33
73831115|NCT03454555|147208832|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|||||1.5|-1.8|0.86
73831116|NCT03454555|147208833|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.76|TWO_SIDED|95.0|-1.4|1.9|||Mixed Models Analysis|||||1.9|-1.4|0.76
73831117|NCT03454555|147208834|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.55|TWO_SIDED|95.0|-2.0|1.1|||Mixed Models Analysis|||||1.1|-2.0|0.55
73831118|NCT03454555|147208835|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.52|TWO_SIDED|95.0|-2.1|1.1|||Mixed Models Analysis|||||1.1|-2.1|0.52
73831119|NCT03454555|147208836|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.37|TWO_SIDED|95.0|-0.2|0.4|||Mixed Models Analysis|||||0.4|-0.2|0.37
73831120|NCT03454555|147208837|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.91|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.91
73831121|NCT03454555|147208838|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.33|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.33
73831122|NCT03454555|147208839|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||||0.6|-0.3|0.46
73831123|NCT03454555|147208840|SUPERIORITY||Risk Difference (RD)|-0.02||||0.52|TWO_SIDED|95.0|-0.08|0.04|||Chi-squared|||||0.04|-0.08|0.52
73831124|NCT03454555|147208841|SUPERIORITY||Odds Ratio (OR)|1.48||||0.17|TWO_SIDED|95.0|0.85|2.59|||Mixed Models Analysis|Used a generalized logistic model for repeated measurements; modeled the outcome of intention to taper.||||2.59|0.85|0.17
73831125|NCT03454555|147208842|SUPERIORITY||Odds Ratio (OR)|1.28||||0.41|TWO_SIDED|95.0|0.71|2.31|||Mixed Models Analysis|Used a generalized logistic model for repeated measurements; modeled the outcome of intention to taper.||||2.31|0.71|0.41
73831126|NCT03454555|147208843|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
73831127|NCT03454555|147208844|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||0.67
73831128|NCT05399485|147208850|SUPERIORITY||[Difference in Least square (LS) Mean]|-1.1||||0.0021|TWO_SIDED|95.0|-1.73|-0.38|||Mixed Models Analysis|||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as a covariate, treatment group, randomization stratum (stable prophylactic migraine medication use throughout randomization), month, and month-by treatment group interaction as fixed effects.||-0.38|-1.73|0.0021
73831129|NCT05399485|147208851|SUPERIORITY||Difference in Percentage|7.3||||0.0989|TWO_SIDED|95.0|-1.4|15.9||P-value \>0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Mantel Haenszel|||The percentages of participants with reductions were compared between treatment groups using Mantel-Haenszel risk estimation with stratification by randomization stratum (stable prophylactic migraine medication use throughout randomization; yes, no).||15.9|-1.4|0.0989
73831130|NCT03405870|147208883|OTHER|Determined maximum tolerated dose|Value of Maximum Tolerated Dose (g/kg)|1.6|||||TWO_SIDED|||||||||Using sequential dose escalation, participants received 2 doses of 1.0 to 1.6 g/kg of lipid emulsion (Smoflipid 20% lipid emulsion) within 48 hours of enrollment to test the maximum tolerated dose of study drug. The maximum tolerated dose was defined by patients exhibiting specific dose-related toxicities from administration of escalating doses of the study drug. Of 9 patients, adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria.||||
73831131|NCT03643848|147208911|SUPERIORITY||variance components; inferring mean diff|0.068|STANDARD_DEVIATION|0.033|<|0.046|TWO_SIDED|||||a priori threshold p\<.05|Mixed Models Analysis|REML; Satterwaite method for t-tests.Participant is random effect. Addtnl fixed effects: Valence, Condition, Anxiety Severity, Gender, Age (months).||Condition (TMR, Sham) x Valence (Negative, Neutral) predicting Lure Generalization Index at 1 week. We hypothesized a significant interaction, with a reduction in negative generalization and an increase in neutral generalization in the TMR condition.||||<.046
73831132|NCT03643848|147208912|SUPERIORITY||variance components; inferring mean diff|-0.033|STANDARD_ERROR_OF_MEAN|0.064|=|0.61|TWO_SIDED|||||a priori p\<.05|Mixed Models Analysis|included additional fixed effects: Anxiety severity, gender, age (months)||Condition (TMR, Sham) x Valence (Negative, Neutral) predicting Lure Generalization Index at 12 hour test. We hypothesized a significant interaction, with a reduction in negative generalization and an increase in neutral generalization in the TMR condition.||||=.61
73831133|NCT06023563|147208923|OTHER|The required sample size for medium effect size (f = 0.25) and power of 0.80 was calculated to be 6 participants in each group (n =12) (G\*power 3.1.9.7 software). Data were analyzed using IBM SPSS statistical package (version 29.0.1.0).|||||<|0.05|||||||Friedman's test|||A virtual reality active video gaming intervention will be more effective than traditional physical therapy based balance exercises, both based on motor learning principles, in improving static and dynamic balance in youth and young adults with ASD and these improvements will be retained at 4 weeks after the intervention.||||< 0.05
73831134|NCT06023563|147208924|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
73831135|NCT06023563|147208925|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
73831136|NCT06023563|147208926|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
73831137|NCT06023563|147208927|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
73831138|NCT06023563|147208928|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
73831139|NCT06023563|147208929|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
73831140|NCT06023563|147208930|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
73831141|NCT00614393|147208962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.41||||0.06|TWO_SIDED|95.0|0.99|2.0|||Regression, Cox|||||2.00|0.99|0.06
73831142|NCT00614393|147208962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.18|TWO_SIDED|95.0|0.89|1.79|||Regression, Cox|||||1.79|0.89|0.18
73831143|NCT00614393|147208963|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||0.07|TWO_SIDED|95.0|0.98|1.83|||Regression, Cox|||||1.83|0.98|0.07
73831144|NCT00614393|147208963|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.44|TWO_SIDED|95.0|0.83|1.55|||Regression, Cox|||||1.55|0.83|0.44
73831145|NCT00855582|147208969|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.58|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831146|NCT00855582|147208970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|0.66|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831147|NCT00855582|147208971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.59||0.181||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.181
73831148|NCT00855582|147208972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|0.67|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831149|NCT00855582|147208973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7|STANDARD_ERROR_OF_MEAN|2.8|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831150|NCT00855582|147208974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831151|NCT00855582|147208975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|2.85|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831152|NCT00855582|147208976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.26||0.156||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.156
73831153|NCT00855582|147208977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.226||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.226
73831154|NCT00855582|147208977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831155|NCT00855582|147208978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.53||0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.121
73831156|NCT00855582|147208978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.57||0.169||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.169
73831157|NCT00855582|147208978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.52|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831158|NCT00855582|147208978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.56|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831159|NCT00855582|147208979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831160|NCT00855582|147208979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831161|NCT00855582|147208979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|0.59|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831162|NCT00855582|147208979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831163|NCT00855582|147208980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831164|NCT00855582|147208980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831165|NCT00855582|147208980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.5|STANDARD_ERROR_OF_MEAN|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831166|NCT00855582|147208980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831167|NCT00855582|147208981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.215||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.215
73831168|NCT00855582|147208981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.325||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.325
73831169|NCT00855582|147208981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831170|NCT00855582|147208981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.23||0.011||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.011
73831171|NCT00855582|147208982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.23||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.230
73831172|NCT00855582|147208982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.37|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831173|NCT00855582|147208983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.191||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.191
73831174|NCT00855582|147208983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831175|NCT00855582|147208984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.763||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.763
73831176|NCT00855582|147208984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.075||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.075
73831177|NCT00855582|147208985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.384||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.384
73831178|NCT00855582|147208985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.082||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.082
73831179|NCT00855582|147208986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831180|NCT00855582|147208986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831181|NCT00855582|147208987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831182|NCT00855582|147208987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831183|NCT00855582|147208988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831184|NCT00855582|147208988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831185|NCT00855582|147208989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831186|NCT00855582|147208989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831187|NCT00855582|147208990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831188|NCT00855582|147208990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.8|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831189|NCT00855582|147208991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.9|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831190|NCT00855582|147208991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.7|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831191|NCT00855582|147208992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831192|NCT00855582|147208992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.4|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
73831193|NCT00855582|147208993|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
73831194|NCT00855582|147208993|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
73831195|NCT00855582|147208994|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||0.006
73831196|NCT00855582|147208994|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
73831197|NCT00855582|147208995|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
73831198|NCT00855582|147208995|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
73831199|NCT00855582|147208995|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
73831200|NCT00855582|147208995|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
73831201|NCT00855582|147208996|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA|||||||0.027
73831202|NCT00855582|147208996|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA|||||||0.186
73831203|NCT03345004|147208999|SUPERIORITY||Estimated ratio|1.091|||=|0.5009|TWO_SIDED|95.0|0.845|1.408|||Mixed Models Analysis|||||1.408|0.845|= 0.5009
73831204|NCT03345004|147208999|SUPERIORITY||Estimated ratio|1.557|||=|0.0078|TWO_SIDED|95.0|1.126|2.153|||Mixed Models Analysis|||||2.153|1.126|= 0.0078
73831205|NCT01013753|147209020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.097|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.182|0.097|<0.0001
73831206|NCT01013753|147209020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.14|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.224|0.140|<0.0001
73831207|NCT01013753|147209020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.205|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.163|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.248|0.163|<0.0001
73831208|NCT01013753|147209020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.186|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.272|0.186|<0.0001
73831209|NCT01013753|147209020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.126|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.211|0.126|<0.0001
73831210|NCT01013753|147209021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.116|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.211|0.116|<0.0001
73831211|NCT01013753|147209021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.166|0.259|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.259|0.166|<0.0001
73831212|NCT01013753|147209021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.186|0.28|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.280|0.186|<0.0001
73831213|NCT01013753|147209021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.203|0.298|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.298|0.203|<0.0001
73831214|NCT01013753|147209021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.137|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.231|0.137|<0.0001
73831215|NCT01013753|147209022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.073|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.158|0.073|<0.0001
73831216|NCT01013753|147209022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.193|0.110|<0.0001
73831217|NCT01013753|147209022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.135|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.219|0.135|<0.0001
73831218|NCT01013753|147209022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.164|0.25|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.250|0.164|<0.0001
73831219|NCT01013753|147209022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.11|0.194|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.194|0.110|<0.0001
73831220|NCT01013753|147209023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.056|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.148|0.056|<0.0001
73831221|NCT01013753|147209023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.09|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.180|0.090|<0.0001
73831222|NCT01013753|147209023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.116|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.207|0.116|<0.0001
73831223|NCT01013753|147209023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.134|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.226|0.134|<0.0001
73831224|NCT01013753|147209023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.12|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.211|0.120|<0.0001
73831225|NCT01013753|147209024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.058|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.148|0.058|<0.0001
73831226|NCT01013753|147209024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.088|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.177|0.088|<0.0001
73831227|NCT01013753|147209024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.124|0.214|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.214|0.124|<0.0001
73831228|NCT01013753|147209024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.153|0.244|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.244|0.153|<0.0001
73831229|NCT01013753|147209024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.058|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.147|0.058|<0.0001
73831230|NCT01013753|147209025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.052|0.154|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.154|0.052|<0.0001
73831231|NCT01013753|147209025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.106|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.207|0.106|<0.0001
73831232|NCT01013753|147209025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.091|0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.192|0.091|<0.0001
73831233|NCT01013753|147209025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.118|0.221|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.221|0.118|<0.0001
73831234|NCT01013753|147209025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.051|0.153|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.153|0.051|<0.0001
73831235|NCT01013753|147209026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.024||0.0107||95.0|0.014|0.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.107|0.014|0.0107
73831236|NCT01013753|147209026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.069|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.160|0.069|<0.0001
73831237|NCT01013753|147209026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.069|0.161|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.161|0.069|<0.0001
73831238|NCT01013753|147209026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.098|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.191|0.098|<0.0001
73831239|NCT01013753|147209026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.024||0.0001||95.0|0.044|0.137|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.137|0.044|0.0001
73831240|NCT01013753|147209027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.023||0.0005||95.0|0.036|0.128|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.128|0.036|0.0005
73831241|NCT01013753|147209027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.09|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.181|0.090|<0.0001
73831242|NCT01013753|147209027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.083|0.174|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.174|0.083|<0.0001
73831243|NCT01013753|147209027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.111|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.203|0.111|<0.0001
73831244|NCT01013753|147209027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.051|0.143|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.143|0.051|<0.0001
73831245|NCT01013753|147209028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.028||0.0952||95.0|-0.008|0.103|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.103|-0.008|0.0952
73831246|NCT01013753|147209028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.028||0.0003||95.0|0.048|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.158|0.048|0.0003
73831247|NCT01013753|147209028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.028||0.0016||95.0|0.034|0.145|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.145|0.034|0.0016
73831248|NCT01013753|147209028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.071|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.183|0.071|<0.0001
73831249|NCT01013753|147209028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.028||0.0096||95.0|0.018|0.129|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.129|0.018|0.0096
73831250|NCT01013753|147209029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.147||95.0|-0.013|0.088|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.088|-0.013|0.1470
73831251|NCT01013753|147209029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.025||0.0003||95.0|0.042|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.141|0.042|0.0003
73831252|NCT01013753|147209029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.06|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.160|0.060|<0.0001
73831253|NCT01013753|147209029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.078|0.179|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.179|0.078|<0.0001
73831254|NCT01013753|147209029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.025||0.0448||95.0|0.001|0.101|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.101|0.001|0.0448
73831255|NCT01013753|147209030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.408|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.277|0.539|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.539|0.277|<0.0001
73831256|NCT01013753|147209030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.566|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.438|0.695|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.695|0.438|<0.0001
73831257|NCT01013753|147209030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.612|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.482|0.743|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.743|0.482|<0.0001
73831258|NCT01013753|147209030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.539|0.801|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.801|0.539|<0.0001
73831259|NCT01013753|147209030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.588|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.457|0.718|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.718|0.457|<0.0001
73831260|NCT01013753|147209031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.213|0.461|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.461|0.213|<0.0001
73831261|NCT01013753|147209031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.485|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.363|0.606|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.606|0.363|<0.0001
73831262|NCT01013753|147209031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.531|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.408|0.655|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.655|0.408|<0.0001
73831263|NCT01013753|147209031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.648|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.524|0.772|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.772|0.524|<0.0001
73831264|NCT01013753|147209031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.551|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.428|0.674|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.674|0.428|<0.0001
73831265|NCT01013753|147209032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.373|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.253|0.493|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.493|0.253|<0.0001
73831266|NCT01013753|147209032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.527|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.409|0.645|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.645|0.409|<0.0001
73831267|NCT01013753|147209032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.572|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.453|0.692|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.692|0.453|<0.0001
73831268|NCT01013753|147209032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.54|0.781|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.781|0.540|<0.0001
73831269|NCT01013753|147209032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.451|0.689|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.689|0.451|<0.0001
73831270|NCT01013753|147209033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.168|0.436|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.436|0.168|<0.0001
73831271|NCT01013753|147209033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.429|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.297|0.561|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.561|0.297|<0.0001
73831272|NCT01013753|147209033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.333|0.599|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.599|0.333|<0.0001
73831273|NCT01013753|147209033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.4|0.669|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.669|0.400|<0.0001
73831274|NCT01013753|147209033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.504|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.371|0.637|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.637|0.371|<0.0001
73831275|NCT01013753|147209034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.07||0.0002||95.0|0.127|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.401|0.127|0.0002
73831276|NCT01013753|147209034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.468|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.333|0.602|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.602|0.333|<0.0001
73831277|NCT01013753|147209034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.348|0.62|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.620|0.348|<0.0001
73831278|NCT01013753|147209034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.624|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.487|0.761|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.761|0.487|<0.0001
73831279|NCT01013753|147209034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.447|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.311|0.583|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.583|0.311|<0.0001
73831280|NCT01013753|147209035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.012|STANDARD_ERROR_OF_MEAN|3.671|<|0.0001||95.0|14.802|29.223|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||29.223|14.802|<0.0001
73831281|NCT01013753|147209035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.022|STANDARD_ERROR_OF_MEAN|3.61|<|0.0001||95.0|21.931|36.114|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||36.114|21.931|<0.0001
73831282|NCT01013753|147209035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.887|STANDARD_ERROR_OF_MEAN|3.631|<|0.0001||95.0|20.755|35.019|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||35.019|20.755|<0.0001
73831283|NCT01013753|147209035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.935|STANDARD_ERROR_OF_MEAN|3.668|<|0.0001||95.0|25.73|40.139|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||40.139|25.730|<0.0001
73831284|NCT01013753|147209035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.528|STANDARD_ERROR_OF_MEAN|3.644|<|0.0001||95.0|16.371|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||30.686|16.371|<0.0001
73831285|NCT01013753|147209036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.92|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001||95.0|7.77|22.071|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||22.071|7.770|<0.0001
73831286|NCT01013753|147209036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.834|STANDARD_ERROR_OF_MEAN|3.58|<|0.0001||95.0|17.801|31.866|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||31.866|17.801|<0.0001
73831287|NCT01013753|147209036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.613|STANDARD_ERROR_OF_MEAN|3.601|<|0.0001||95.0|16.539|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||30.686|16.539|<0.0001
73831288|NCT01013753|147209036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.449|STANDARD_ERROR_OF_MEAN|3.637|<|0.0001||95.0|21.305|35.594|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||35.594|21.305|<0.0001
73831289|NCT01013753|147209036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.439|STANDARD_ERROR_OF_MEAN|3.614|<|0.0001||95.0|13.341|27.538|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||27.538|13.341|<0.0001
73831290|NCT01013753|147209037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.994|STANDARD_ERROR_OF_MEAN|0.507|<|0.0001||95.0|-2.989|-0.999|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.999|-2.989|<0.0001
73831291|NCT01013753|147209037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.095|STANDARD_ERROR_OF_MEAN|0.498|<|0.0001||95.0|-3.073|-1.116|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-1.116|-3.073|<0.0001
73831292|NCT01013753|147209037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.836|STANDARD_ERROR_OF_MEAN|0.503||0.0003||95.0|-2.824|-0.849|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.849|-2.824|0.0003
73831293|NCT01013753|147209037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.789|STANDARD_ERROR_OF_MEAN|0.506||0.0004||95.0|-2.783|-0.795|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.795|-2.783|0.0004
73831294|NCT01013753|147209037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.503||0.0118||95.0|-2.258|-0.283|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.283|-2.258|0.0118
73831295|NCT01013753|147209038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.025||0.0002||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.141|0.045|0.0002
73831296|NCT01013753|147209038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.081|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.081|<0.0001
73831297|NCT01013753|147209038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.087|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.183|0.087|<0.0001
73831298|NCT01013753|147209038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.121|0.217|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.217|0.121|<0.0001
73831299|NCT01013753|147209038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.024||0.0001||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.141|0.045|0.0001
73831300|NCT01013753|147209039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.024||0.0362||95.0|0.003|0.097|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.097|0.003|0.0362
73831301|NCT01013753|147209039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.023||0.0006||95.0|0.035|0.127|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.127|0.035|0.0006
73831302|NCT01013753|147209039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.024||0.0002||95.0|0.042|0.135|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.135|0.042|0.0002
73831303|NCT01013753|147209039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.07|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.164|0.070|<0.0001
73831304|NCT01013753|147209039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.024||0.001||95.0|0.032|0.125|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.125|0.032|0.0010
73831305|NCT01013753|147209040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001||95.0|-0.77|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.282|-0.770|<0.0001
73831306|NCT01013753|147209040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.432|STANDARD_ERROR_OF_MEAN|0.122||0.0004||95.0|-0.671|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.192|-0.671|0.0004
73831307|NCT01013753|147209040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.478|STANDARD_ERROR_OF_MEAN|0.123||0.0001||95.0|-0.72|-0.237|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.237|-0.720|0.0001
73831308|NCT01013753|147209040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.657|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001||95.0|-0.901|-0.413|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.413|-0.901|<0.0001
73831309|NCT01013753|147209040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.449|STANDARD_ERROR_OF_MEAN|0.123||0.0003||95.0|-0.691|-0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.207|-0.691|0.0003
73831310|NCT01013753|147209045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.289|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.178|0.4|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.400|0.178|<0.0001
73831311|NCT01013753|147209045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.056||0.0002||95.0|0.099|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.318|0.099|0.0002
73831312|NCT01013753|147209045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.151|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.374|0.151|<0.0001
73831313|NCT01013753|147209045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.205|0.429|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.429|0.205|<0.0001
73831314|NCT01013753|147209045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.315|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.203|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.426|0.203|<0.0001
73831315|NCT01013753|147209046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.321|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|-0.432|-0.21|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.210|-0.432|<0.0001
73831316|NCT01013753|147209046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.403|-0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.184|-0.403|<0.0001
73831317|NCT01013753|147209046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.436|-0.215|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.215|-0.436|<0.0001
73831318|NCT01013753|147209046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.394|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|-0.505|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.282|-0.505|<0.0001
73831319|NCT01013753|147209046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.457|-0.235|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.235|-0.457|<0.0001
73831320|NCT01013753|147209047|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.996||||0.6187||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.011|0.981|0.6187
73831321|NCT01013753|147209047|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.996||||0.6022||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||1.011|0.981|0.6022
73831322|NCT01013753|147209047|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.999||||0.8641||95.0|0.984|1.014|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||1.014|0.984|0.8641
73831323|NCT01013753|147209047|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.998||||0.7664||95.0|0.983|1.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||1.013|0.983|0.7664
73831324|NCT01013753|147209047|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.003||||0.6757||95.0|0.988|1.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.018|0.988|0.6757
73831325|NCT01013753|147209048|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.993||||0.4423||95.0|0.975|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.011|0.975|0.4423
73831326|NCT01013753|147209048|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.979||||0.0218||95.0|0.962|0.997|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.997|0.962|0.0218
73831327|NCT01013753|147209048|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.977||||0.0109||95.0|0.96|0.995|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.995|0.960|0.0109
73831328|NCT01013753|147209048|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0283||95.0|0.962|0.998|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.998|0.962|0.0283
73831329|NCT01013753|147209048|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.991||||0.3085||95.0|0.973|1.009|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.009|0.973|0.3085
73831330|NCT01013753|147209049|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.999||||0.9112||95.0|0.984|1.015|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.015|0.984|0.9112
73831331|NCT01013753|147209049|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.992||||0.2955||95.0|0.977|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||1.007|0.977|0.2955
73831332|NCT01013753|147209049|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.987||||0.1029||95.0|0.973|1.003|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||1.003|0.973|0.1029
73831333|NCT01013753|147209049|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.991||||0.2552||95.0|0.975|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||1.007|0.975|0.2552
73831334|NCT01013753|147209049|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.994||||0.4803||95.0|0.979|1.01|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.010|0.979|0.4803
73831335|NCT03320369|147209059|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73831336|NCT01732692|147209063|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint was analyzed by a non-inferiority test using the exact Farrington-Manning method. Non-inferiority of the two treatments was to be concluded if the lower end of the confidence interval of the difference the experimental treatment group (morning-only dose) - control treatment group (split dose) was above a non-inferiority margin of -0.15%.|Treatment Difference|0.0286|||<|0.001|ONE_SIDED|95.0|-0.097||||Exact Farrington - Manning||Treatment Difference is the difference in proportion of participants with successful colon cleansing between treatments -experimental vs. control||||-0.097|<0.001
73831337|NCT03331562|147209103|SUPERIORITY||Risk Ratio (RR)|0.0||||0.31|ONE_SIDED|95.0|0.0||||Fisher Exact||Lower bound cannot be estimated because there were 0 events in the comparison group.||||0|.31
73831338|NCT05383209|147209182|OTHER||Difference in response percentage|-5.0|||||TWO_SIDED|95.0|-24.9|13.4||||||||13.4|-24.9|
73831339|NCT05383209|147209182|OTHER||Slope|-0.2|||||TWO_SIDED|95.0|-20.6|20.6||||||||20.6|-20.6|
73831340|NCT05383209|147209183|OTHER||Difference in response percentage|5.3|||||TWO_SIDED|95.0|-13.2|26.0||||||||26.0|-13.2|
73831341|NCT06525727|147209230|OTHER||Sensitivity|97.96|||||TWO_SIDED|95.0|89.15|99.95|||Diagnostic accuracy|Diagnostic performance was analyzed in terms of sensitivity, specificity, NPV, PPV and likelihood ratios, all reported with 95% confidence interval||The primary objective of the study was to assess the external validation of the Falls Decision Rule. In this evaluation, patients were categorized into two groups based on the rule: those for whom a CT scan was recommended and those for whom it was not.||99.95|89.15|
73831342|NCT06525727|147209230|OTHER||Specificity|31.96|||||TWO_SIDED|95.0|28.63|35.42|||Diagnostic accuracy|||||35.42|28.63|
73831343|NCT06525727|147209230|OTHER||Negative predictive value|99.59|||||TWO_SIDED|95.0|97.17|99.94|||Diagnostic accuracy|||||99.94|97.17|
73831344|NCT06525727|147209230|OTHER||Positive predictive value|8.59|||||TWO_SIDED|95.0|8.1|9.1|||Diagnostic accuracy|||||9.1|8.1|
73831345|NCT06525727|147209230|OTHER||Negative likelihood ratio|0.06|||||TWO_SIDED|95.0|0.01|0.42|||Diagnostic accuracy|||||0.42|0.01|
73831346|NCT06525727|147209230|OTHER||Positive likelihood ratio|1.44|||||TWO_SIDED|95.0|1.35|1.53|||Diagnostic accuracy|||||1.53|1.35|
73831347|NCT01138735|147209238|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by analysis center, using general association statistics||"null hypothesis: no difference in Success rate in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle).~power calculation: 90%"||||<0.001
73831348|NCT01138735|147209239|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.|ANCOVA|normality assumption is not met. ANCOVA Model: Ranked Change in Total Lesion Counts = Ranked Baseline Lesion Counts, Analysis Center, Treatment.||null hypothesis: no difference in change from baseline in total lesion count in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle)||||<0.001
73831349|NCT01138735|147209240|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|CMH test with row mean difference statistic using relative to an identified distribution(RIDIT) score, controlling for analysis center||||||<0.001
73831350|NCT01138735|147209241|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Ranked Change in Inflammatory Lesion Counts = Ranked Baseline Inflammatory Lesion Counts, Analysis Center, Treatment||||||<0.001
73831351|NCT00207740|147209242|SUPERIORITY_OR_OTHER|||||||0.802||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|ANCOVA|||The null hypothesis was that the endpoint for placebo is the same as that for combined 100 mg and 200 mg golimumab. Assuming a standard deviation of 23%, there is 86% power to detect a 10% difference at a 0.05 significance level.||||0.802
73831352|NCT00207740|147209242|SUPERIORITY_OR_OTHER|||||||0.945||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.945
73831353|NCT00207740|147209242|SUPERIORITY_OR_OTHER|||||||0.717||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.717
73831354|NCT00207740|147209242|SUPERIORITY_OR_OTHER|||||||0.357||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.357
73831355|NCT00207740|147209243|SUPERIORITY_OR_OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.286
73831356|NCT00207740|147209243|SUPERIORITY_OR_OTHER|||||||0.742|||||||Wilcoxon (Mann-Whitney)|||||||0.742
73831357|NCT00207740|147209243|SUPERIORITY_OR_OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
73831358|NCT00207740|147209243|SUPERIORITY_OR_OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
73831359|NCT00207740|147209244|SUPERIORITY_OR_OTHER|||||||0.718||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|Cochran-Mantel-Haenszel|||The null hypothesis was that the number of severe exacerbations per patient from baseline through week 24 for placebo is the same as that in the combined 100 mg and 200 mg golimumab. Assuming 1 severe exacerbation over 6 months per patient in the placebo group, there is 79% power to detect a 35% reduction in the combined 100 mg and 200 mg golimumab group at a 0.05 significance level.||||0.718
73831360|NCT00207740|147209244|SUPERIORITY_OR_OTHER|||||||0.779||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.779
73831361|NCT00207740|147209244|SUPERIORITY_OR_OTHER|||||||0.649||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.649
73831362|NCT00207740|147209244|SUPERIORITY_OR_OTHER|||||||0.256||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.256
73831363|NCT00207740|147209245|SUPERIORITY_OR_OTHER|||||||0.894|||||||Kruskal-Wallis|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.894
73831364|NCT00207740|147209245|SUPERIORITY_OR_OTHER|||||||0.572|||||||Kruskal-Wallis|||||||0.572
73831365|NCT00207740|147209245|SUPERIORITY_OR_OTHER|||||||0.731|||||||Kruskal-Wallis|||||||0.731
73831366|NCT00207740|147209245|SUPERIORITY_OR_OTHER|||||||0.856|||||||Kruskal-Wallis|||||||0.856
73831367|NCT00207740|147209246|SUPERIORITY_OR_OTHER|||||||0.273|||||||Cochran-Mantel-Haenszel|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.273
73831368|NCT00207740|147209246|SUPERIORITY_OR_OTHER|||||||0.382|||||||Cochran-Mantel-Haenszel|||||||0.382
73831369|NCT00207740|147209246|SUPERIORITY_OR_OTHER|||||||0.35|||||||Cochran-Mantel-Haenszel|||||||0.350
73831370|NCT00207740|147209246|SUPERIORITY_OR_OTHER|||||||0.341|||||||Cochran-Mantel-Haenszel|||||||0.341
73831371|NCT00207740|147209247|SUPERIORITY_OR_OTHER|||||||0.986|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.986
73831372|NCT00207740|147209247|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
73831373|NCT00207740|147209247|SUPERIORITY_OR_OTHER|||||||0.858|||||||Wilcoxon (Mann-Whitney)|||||||0.858
73831374|NCT00207740|147209247|SUPERIORITY_OR_OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
73831375|NCT00207740|147209248|SUPERIORITY_OR_OTHER|||||||0.833||95.0|||||ANOVA|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.833
73831376|NCT00207740|147209248|SUPERIORITY_OR_OTHER|||||||0.814||95.0|||||ANOVA|||||||0.814
73831377|NCT00207740|147209248|SUPERIORITY_OR_OTHER|||||||0.897||95.0|||||ANOVA|||||||0.897
73831378|NCT00207740|147209248|SUPERIORITY_OR_OTHER|||||||0.726||95.0|||||ANOVA|||||||0.726
73831379|NCT01811238|147209297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|2.18|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."||||||<0.05
73831380|NCT01811238|147209298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|0.37|<|0.05|TWO_SIDED|95.0|0.0|1.12|||t-test, 2 sided|The change(difference) in EQ-5D score at Week 8 from baseline was analyzed by using paired t-test.||||1.12|0|<0.05
73831381|NCT01192178|147209309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.971||||0.928|TWO_SIDED|95.0|0.519|1.819||Cox Proportional Hazards model adjusted for investigative center|Regression, Cox||The risk of having an asthma exacerbation during the treatment period was analyzed.|||1.819|0.519|0.928
73831382|NCT01155570|147209318|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
73831383|NCT01155570|147209319|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 8||||<0.0001
73831384|NCT01155570|147209320|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
73831385|NCT01155570|147209321|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
73831386|NCT01155570|147209322|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
73831387|NCT01155570|147209323|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
73831388|NCT01155570|147209328|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
73831389|NCT01155570|147209329|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
73831390|NCT01155570|147209330|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
73831391|NCT01155570|147209331|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
73831392|NCT01155570|147209333|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
73831393|NCT01155570|147209334|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
73831394|NCT01155570|147209335|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
73831395|NCT01155570|147209336|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
73831396|NCT01155570|147209337|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
73831397|NCT01155570|147209338|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
73831398|NCT01155570|147209339|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
73831399|NCT00296517|147209340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2||||0.805||95.0|-1.6|2.0|||ANOVA|||Null Hypothesis: The population mean change from baseline on HAM-D total score at Week 12 of the placebo group is equal to the population mean change from baseline on HAMD total score at Week 12 of the Bupropion hydrochloride sustained release group.||2.0|-1.6|0.805
73831400|NCT00296517|147209350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||Log Rank|||||||0.036
73831401|NCT03100747|147209383|SUPERIORITY||Odds Ratio (OR)|1.21||||0.039|TWO_SIDED|98.3|0.97|1.52||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||1.52|0.97|0.039
73831402|NCT03100747|147209383|SUPERIORITY||Odds Ratio (OR)|1.91|||<|0.0001|TWO_SIDED|98.3|1.54|2.36||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||2.36|1.54|<0.0001
73831403|NCT03100747|147209383|SUPERIORITY||Odds Ratio (OR)|1.57|||<|0.0001|TWO_SIDED|98.3|1.29|1.92||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||1.92|1.29|<0.0001
73831404|NCT03100747|147209388|SUPERIORITY||Odds Ratio (OR)|0.84||||0.094|TWO_SIDED|98.3|0.65|1.08||p-values adjusted for multiple comparisons|Regression, Logistic|||||1.08|0.65|0.094
73831405|NCT03100747|147209388|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|98.3|0.38|0.67||p-value adjusted for multiple comparisons, the a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||0.67|0.38|<0.0001
73831406|NCT03100747|147209388|SUPERIORITY||Odds Ratio (OR)|0.6|||<|0.0001|TWO_SIDED|98.3|0.45|0.8||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||0.80|0.45|<0.0001
73831407|NCT03100747|147209393|SUPERIORITY||Odds Ratio (OR)|0.86||||0.24|TWO_SIDED|98.3|0.64|1.17|||Regression, Logistic|||||1.17|0.64|0.24
73831408|NCT03100747|147209393|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0037|TWO_SIDED|98.3|0.49|0.93|||Regression, Logistic|||||0.93|0.49|0.0037
73831409|NCT03100747|147209393|SUPERIORITY||Odds Ratio (OR)|0.78||||0.08|TWO_SIDED|98.3|0.57|1.09|||Regression, Logistic|||||1.09|0.57|0.08
73831410|NCT00055237|147209442|SUPERIORITY_OR_OTHER||proportion estimate,binomial exact 95%CI|31.0|STANDARD_DEVIATION|11.6|||TWO_SIDED|95.0|11.0|58.7|||sample estimate with 95% CI||As stated in the Outcome statistical Analysis 1. Section, the confidence interval was calculated using binomial exact statistics. The standard deviation is based on that calculation.|||58.7|11|
73831411|NCT03834168|147209446|OTHER|||||||0.003|||||||Regression (Cosinor Fit)|||||||0.003
73831412|NCT03834168|147209446|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<0.001
73831413|NCT03556683|147209449|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Effect immediately following hypertonic saline treatment.||||<0.001
73831414|NCT03556683|147209450|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||Effect of hypertonic saline 4 hours after treatment.||||0.99
73831415|NCT04757636|147209452|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|1.03||0.861409|TWO_SIDED|95.0|-2.2|1.84|||MMRM|||||1.84|-2.20|0.861409
73831416|NCT04757636|147209452|SUPERIORITY||Least Squares Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|1.029||0.416264|TWO_SIDED|95.0|-2.86|1.18|||MMRM|||||1.18|-2.86|0.416264
73831417|NCT04757636|147209453|SUPERIORITY||Risk Difference (RD)|0.1||||0.981348|TWO_SIDED|95.0|-7.5|7.7|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||7.7|-7.5|0.981348
73831418|NCT04757636|147209453|SUPERIORITY||Risk Difference (RD)|-0.7||||0.856|TWO_SIDED|95.0|-8.5|7.0|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||7.0|-8.5|0.856000
73831419|NCT04757636|147209454|SUPERIORITY||Risk Difference (RD)|-1.7||||0.655104|TWO_SIDED|95.0|-8.9|5.6|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||5.6|-8.9|0.655104
73831420|NCT04757636|147209454|SUPERIORITY||Risk Difference (RD)|-0.8||||0.821257|TWO_SIDED|95.0|-8.2|6.5|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||6.5|-8.2|0.821257
73831421|NCT04757636|147209455|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.234||0.199828|TWO_SIDED|95.0|-0.76|0.16|||MMRM|||||0.16|-0.76|0.199828
73831422|NCT04757636|147209455|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.235||0.188725|TWO_SIDED|95.0|-0.77|0.15|||MMRM|||||0.15|-0.77|0.188725
73831423|NCT04757636|147209456|SUPERIORITY||Risk Difference (RD)|-0.5||||0.84781|TWO_SIDED|95.0|-5.6|4.6|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||4.6|-5.6|0.847810
73831424|NCT04757636|147209456|SUPERIORITY||Risk Difference (RD)|0.9||||0.718699|TWO_SIDED|95.0|-4.2|6.1|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||6.1|-4.2|0.718699
73831425|NCT00621530|147209492|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.94|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Power calculation assumed that all subjects would have an area of hypersensitivity surrounding the wound at 48 hours. We found that only 1 subject in the placebo group and 3 subjects in the ketorolac group had non-zero areas of hypersensitivity.||||=0.94
73831426|NCT00621530|147209493|SUPERIORITY||||||=|0.78|||||||ANOVA|Repeated measures ANOVA||||||=0.78
73831427|NCT00621530|147209494|SUPERIORITY||||||=|0.87|||||||ANOVA|Repeated measures ANOVA||||||=0.87
73831428|NCT00621530|147209495|SUPERIORITY||||||=|0.66|||||||ANOVA|Repeated measures ANOVA||||||=0.66
73831429|NCT00621530|147209496|SUPERIORITY||||||=|0.83|||||||ANOVA|Repeated measures ANOVA||||||=0.83
73831430|NCT00671060|147209497|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.682|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||Rates of success were compared across study arms. The study was a separate, non-comparative efficacy study. In order to have 80% power (alpha=.05) to demonstrate that each misoprostol regimen was 95%, ± 5%, effective, we enrolled 73 women in each arm of the study, or 146 women total. The sample size also provided 80% power (alpha=.05) to detect a significant difference between treatments should 200μg prove 98% effective and 100μg prove 88% effective.||||<0.05
73831431|NCT02832037|147209520|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0145||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0145
73831432|NCT02832037|147209520|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0148||||||Adjusted for multiplicity.|MCP-Mod linear in log model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0148
73831433|NCT02832037|147209520|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0089||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|Model assumption: 20% of the maximum effect is achieved at 2 mg of BI 425809 .||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0089
73831434|NCT02832037|147209520|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0038||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|Model assumption: 25% of the maximum effect is achieved at 5 mg and 75% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0038
73831435|NCT02832037|147209520|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0085||||||Adjusted for multiplicity.|MCP-Mod logistic model fit|Model assumption: 10% of the maximum effect is achieved at 5 mg and 50% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0085
73831436|NCT02832037|147209520|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.228||||||Adjusted for multiplicity.|MCP-Mod beta model fit|Assumption:75% of maximum (max) effect at 2mg, 87.5% of max effect at 5mg,25% of max effect at 25mg,max effect at 10mg BI 425809, scalar parameter=26.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2280
73831437|NCT02832037|147209520|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|0.28|STANDARD_ERROR_OF_MEAN|0.8205||0.733|TWO_SIDED|95.0|-1.332|1.892||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.892|-1.332|0.7330
73896553|NCT03456882|147326413|SUPERIORITY||Mean Difference (Net)|-7.7|STANDARD_ERROR_OF_MEAN|15.7||0.6263|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.6263
73896554|NCT03456882|147326414|SUPERIORITY||Mean Difference (Final Values)|-19.0|STANDARD_ERROR_OF_MEAN|21.0||0.3671|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.3671
73896555|NCT03456882|147326415|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.22||0.845|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.845
73896556|NCT03456882|147326416|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2161|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.2161
73896557|NCT03456882|147326417|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.4962|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.4962
73896558|NCT03456882|147326418|SUPERIORITY|||||||0.8738||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 4 weeks. Null hypothesis: the number of adverse events occurred within 4 weeks is not different between groups||||0.8738
73896559|NCT03456882|147326418|SUPERIORITY|||||||0.7556||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 12 weeks. Null hypothesis: the number of adverse events occurred within 12 weeks is not different between groups||||0.7556
73896560|NCT03456882|147326418|SUPERIORITY|||||||0.6477||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 24 weeks. Null hypothesis: the number of adverse events occurred within 24 weeks is not different between groups||||0.6477
73896561|NCT03456882|147326418|SUPERIORITY|||||||0.6084||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 48 weeks. Null hypothesis: the number of adverse events occurred within 48 weeks is not different between groups||||0.6084
73896562|NCT02342418|147326419|SUPERIORITY_OR_OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
73896563|NCT02342418|147326420|SUPERIORITY_OR_OTHER|||||||0.214|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pair signed-rank test||||0.214
73896564|NCT00428584|147326425|SUPERIORITY_OR_OTHER|||||||0.524||||||P value refers to mean change to 30 minute post injection|ANOVA|||The primary efficacy endpoint was analyzed by using a two-way ANOVA model on ranked data including treatment group and site as fixed effect.||||0.524
73896565|NCT00428584|147326426|SUPERIORITY_OR_OTHER|||||||0.484|||||||ANOVA|||||||0.484
73896566|NCT00428584|147326427|SUPERIORITY_OR_OTHER|||||||0.838|||||||ANOVA|||||||0.838
73896567|NCT00428584|147326428|SUPERIORITY_OR_OTHER|||||||0.451||||||No pain is defined as a VAS = 0 for all 21 full dose injections.|Cochran-Mantel-Haenszel|||||||0.451
73896568|NCT00428584|147326429|SUPERIORITY_OR_OTHER|||||||0.338|||||||ANOVA|||||||0.338
73896569|NCT03602560|147326446|OTHER|The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4).|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73896570|NCT03602560|147326446|OTHER|The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4).|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73896571|NCT03602560|147326447|OTHER|Two-sided p-value for each pair-wise comparison was based on the CMH test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 350 U/L; pruritus NRS: \<4 and 4). Breslow-Day test was used to check the homogeneity of treatment effects across stratum.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73896572|NCT03602560|147326447|OTHER|Two-sided p-value for each pair-wise comparison is based on the Cochran Mantel Haenszel test adjusted for both randomization stratification variables (ALP level: \< 350 U/L and \>= 350 U/L; pruritus NRS: \< 4 and \>= 4). Breslow-Day test is used to check the homogeneity of treatment effects across stratum.||||||0.0839|||||||Cochran-Mantel-Haenszel|||||||0.0839
73896573|NCT03602560|147326448|OTHER|"Change from baseline is estimated by an analysis of covariance (ANCOVA) model with treatment group (including 3 levels:~Placebo, Initial Dose 5mg, and Initial Dose 10 mg) and randomization ALP stratification as factors, and baseline as a covariate.~The p-value for the interaction between treatment and stratum is 0.7595, hence the interaction is dropped from the model."|Risk Difference (RD)|-1.59||||0.0164|TWO_SIDED|95.0|-2.87|-0.3|||ANCOVA|||||-0.3|-2.87|0.0164
73896574|NCT03602560|147326448|OTHER|"Change from baseline is estimated by an analysis of covariance (ANCOVA) model with treatment group (including 3 levels:~Placebo, Initial Dose 5mg, and Initial Dose 10 mg) and randomization ALP stratification as factors, and baseline as a covariate.~The p-value for the interaction between treatment and stratum is 0.7595, hence the interaction is dropped from the model."|Risk Difference (RD)|-0.46||||0.4781|TWO_SIDED|95.0|-1.77|0.84|||ANCOVA|||||0.84|-1.77|0.4781
73896575|NCT03645434|147326473|SUPERIORITY||Mean Difference (Final Values)|0.202|||<|0.0001|TWO_SIDED|95.0|0.151|0.253|||Mixed Models Analysis|||||0.253|0.151|<0.0001
73896576|NCT03645434|147326478|SUPERIORITY||Mean Difference (Final Values)|0.098|||<|0.0001|TWO_SIDED|95.0|0.051|0.146|||Mixed Models Analysis|||Day 2||0.146|0.051|<0.0001
73896577|NCT03645434|147326478|SUPERIORITY||Mean Difference (Final Values)|0.195|||<|0.0001|TWO_SIDED|95.0|0.148|0.242|||Mixed Models Analysis|||Day 8||0.242|0.148|<0.0001
73896578|NCT03645434|147326479|SUPERIORITY||Mean Difference (Final Values)|0.306|||<|0.0001|TWO_SIDED|95.0|0.266|0.346|||Mixed Models Analysis|||Day 1||0.346|0.266|<0.0001
73896579|NCT03645434|147326479|SUPERIORITY||Mean Difference (Final Values)|0.374|||<|0.0001|TWO_SIDED|95.0|0.324|0.425|||Mixed Models Analysis|||Day 8||0.425|0.324|<0.0001
73896580|NCT03645434|147326479|SUPERIORITY||Mean Difference (Final Values)|0.388|||<|0.0001|TWO_SIDED|95.0|0.329|0.447|||Mixed Models Analysis|||Day 14||0.447|0.329|<0.0001
73896581|NCT03645434|147326480|SUPERIORITY||Mean Difference (Final Values)|-0.551||||0.001|TWO_SIDED|95.0|-0.876|-0.226|||Mixed Models Analysis|||Day 1 to Day 8||-0.226|-0.876|0.0010
73896582|NCT03645434|147326480|SUPERIORITY||Mean Difference (Final Values)|-0.867|||<|0.0001|TWO_SIDED|95.0|-1.248|-0.486|||Mixed Models Analysis|||Day 9 to Day 14||-0.486|-1.248|<0.0001
73831438|NCT02832037|147209520|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|0.137|STANDARD_ERROR_OF_MEAN|0.8074||0.8655|TWO_SIDED|95.0|-1.45|1.724||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.724|-1.450|0.8655
73831439|NCT02832037|147209520|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|1.982|STANDARD_ERROR_OF_MEAN|0.7875||0.0122|TWO_SIDED|95.0|0.434|3.53||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||3.530|0.434|0.0122
73831440|NCT02832037|147209520|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|1.73|STANDARD_ERROR_OF_MEAN|0.7884||0.0287|TWO_SIDED|95.0|0.181|3.28||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||3.280|0.181|0.0287
73831441|NCT02832037|147209521|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.066||||||P-value is considered nominal.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0660
73831442|NCT02832037|147209521|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.1619||||||P-value is considered nominal.|MCP-Mod linear in log model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1619
73831443|NCT02832037|147209521|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0832||||||P-value is considered nominal.|MCP-Mod Emax model fit|Model assumption: 20% of the maximum effect is achieved at 2 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0832
73896583|NCT03645434|147326480|SUPERIORITY||Mean Difference (Final Values)|-0.722|||<|0.0001|TWO_SIDED|95.0|-1.047|-0.397|||Mixed Models Analysis|||Day 1 to Day 14||-0.397|-1.047|<0.0001
73896584|NCT03645434|147326481|SUPERIORITY||Mean Difference (Final Values)|-1.571||||0.0022|TWO_SIDED|95.0|-2.563|-0.579|||Mixed Models Analysis|||Day 1 to Day 8||-0.579|-2.563|0.0022
73896585|NCT03645434|147326481|SUPERIORITY||Mean Difference (Final Values)|-2.386|||<|0.0001|TWO_SIDED|95.0|-3.541|-1.23|||Mixed Models Analysis|||Day 9 to Day 14||-1.230|-3.541|<0.0001
73896586|NCT03645434|147326481|SUPERIORITY||Mean Difference (Final Values)|-1.912||||0.0003|TWO_SIDED|95.0|-2.923|-0.901|||Mixed Models Analysis|||Day 1 to Day 14||-0.901|-2.923|0.0003
73896587|NCT03645434|147326492|SUPERIORITY||Mean Difference (Final Values)|-1.268|||<|0.0001|TWO_SIDED|95.0|-1.741|-0.794|||Mixed Models Analysis|||Day 1 to Day 8||-0.794|-1.741|<0.0001
73896588|NCT03645434|147326492|SUPERIORITY||Mean Difference (Final Values)|-1.302|||<|0.0001|TWO_SIDED|95.0|-1.804|-0.8|||Mixed Models Analysis|||Day 9 to Day 14||-0.800|-1.804|<0.0001
73896589|NCT00833664|147326493|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|88.1|109.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.5|88.1|
73896590|NCT00833664|147326494|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|107.6||||||90.0|104.7|110.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.6|104.7|
73896591|NCT00833664|147326495|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|92.7|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.0|92.7|
73831444|NCT02832037|147209521|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0625||||||P-value is considered nominal.|MCP-Mod Sigmoid Emax model fit|Model assumption: 25% of the maximum effect is achieved at 5 mg and 75% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0625
73831445|NCT02832037|147209521|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0768||||||P-value is considered nominal.|MCP-Mod logistic model fit|Model assumption: 10% of the maximum effect is achieved at 5 mg and 50% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0768
73831446|NCT02832037|147209521|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.7479||||||P-value is considered nominal.|MCP-Mod beta model fit|Assumption:75% of maximum (max) effect at 2mg, 87.5% of max effect at 5mg,25% of max effect at 25mg,max effect at 10mg BI 425809, scalar parameter=26.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.7479
73831447|NCT02832037|147209521|OTHER||Difference of adjusted means|1.178|STANDARD_ERROR_OF_MEAN|0.7306||0.11|TWO_SIDED|95.0|-0.258|2.613||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||2.613|-0.258|0.11
73831448|NCT02832037|147209521|OTHER||Difference of adjusted means|-0.837|STANDARD_ERROR_OF_MEAN|0.7224||0.25|TWO_SIDED|95.0|-2.257|0.582||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||0.582|-2.257|0.25
73831449|NCT02832037|147209521|OTHER||Difference of adjusted means|-0.263|STANDARD_ERROR_OF_MEAN|0.7152||0.71|TWO_SIDED|95.0|-1.669|1.142||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.142|-1.669|0.71
73831450|NCT02832037|147209521|OTHER||Difference of adjusted means|-1.072|STANDARD_ERROR_OF_MEAN|0.7125||0.13|TWO_SIDED|95.0|-2.473|0.328||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||0.328|-2.473|0.13
73831451|NCT00435942|147209534|NON_INFERIORITY_OR_EQUIVALENCE|The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|Proportion free|0.97|||>|0.8|ONE_SIDED|97.5|0.93||||1-sided z-test|97.5% 1-sided confidence interval||The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|||.93|>0.80
73831452|NCT03755076|147209562|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73831453|NCT03755076|147209563|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73831454|NCT01953237|147209564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558|||||||Mixed Models Analysis|||||||0.5580
73831455|NCT04167462|147209565|SUPERIORITY||Odds Ratio (OR)|16.49|||<|0.0001|TWO_SIDED|95.0|6.33|42.98|||Cochran-Mantel-Haenszel|||||42.98|6.33|<0.0001
73831456|NCT04167462|147209566|SUPERIORITY||Odds Ratio (OR)|24.29|||<|0.0001|TWO_SIDED|95.0|9.6|61.46|||Cochran-Mantel-Haenszel|||||61.46|9.60|<0.0001
73831457|NCT04167462|147209567|SUPERIORITY||Odds Ratio (OR)|41.19|||<|0.0001|TWO_SIDED|95.0|5.82|291.26|||Cochran-Mantel-Haenszel|||||291.26|5.82|<0.0001
73831458|NCT04167462|147209571|SUPERIORITY||Odds Ratio (OR)|17.27|||<|0.0001|TWO_SIDED|95.0|6.06|49.25|||Cochran-Mantel-Haenszel|||||49.25|6.06|<0.0001
73831459|NCT04167462|147209572|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.0001|TWO_SIDED|95.0|2.19|11.91|||Cochran-Mantel-Haenszel|||||11.91|2.19|<0.0001
73831460|NCT04167462|147209573|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0947|TWO_SIDED|95.0|0.64|53.28|||Cochran-Mantel-Haenszel|||||53.28|0.64|0.0947
73831461|NCT04167462|147209574|SUPERIORITY||Odds Ratio (OR)|4.11||||0.1741|TWO_SIDED|95.0|0.47|35.74|||Cochran-Mantel-Haenszel|||||35.74|0.47|0.1741
73896592|NCT03137069|147326498|SUPERIORITY||Least Squares Mean Difference|-7.02||||0.0559|TWO_SIDED|90.0|-13.01|-1.03|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-1.03|-13.01|0.0559
73831462|NCT00149643|147209582|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||Groups' categorical baseline measures were compared by chi-square analysis, corrected for continuity. Statistical analyses were completed on an intent to-treat study group basis. Outcome measures for depression and for cannabis use and alcohol use across treatment groups were compared by repeated measures analysis of variance. The last observation carried forward (LOCF)method was used for handling missing data in the data analyses.||||<0.05
73831463|NCT03881371|147209585|SUPERIORITY||Least-Square Mean|-1.1|STANDARD_ERROR_OF_MEAN|0.277|<|0.0001|TWO_SIDED|95.0|-1.643|-0.555||"Analysis was based on a covariance model (ANCOVA) with treatment and centre as independent factors, baseline mean total daily OFF time measurement as covariate and change from baseline as dependent variable."|ANCOVA|||Treatment difference (Safinamide - Placebo)||-0.555|-1.643|<.0001
73831464|NCT03881371|147209586|SUPERIORITY||Least-Square Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8901|TWO_SIDED|95.0|-0.44|0.382||ANCOVA with treatment and centre as independent factors, baseline NRS measurement as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||0.382|-0.440|0.8901
73831465|NCT03881371|147209587|SUPERIORITY||Least-Square Mean|0.89|STANDARD_ERROR_OF_MEAN|0.315||0.0049|TWO_SIDED|95.0|0.274|1.515||"ANCOVA with treatment and centre as independent factors, baseline mean total daily ON time measurement as covariate and change from baseline as dependent variable."|ANCOVA|||Treatment difference (Safinamide - Placebo)||1.515|0.274|0.0049
73831466|NCT03881371|147209588|SUPERIORITY||Least-Square Mean|1.07|STANDARD_ERROR_OF_MEAN|0.345||0.0021|TWO_SIDED|95.0|0.392|1.753||"ANCOVA with treatment and centre as independent factors, baseline mean total daily ON time with no/non-troublesome Dyskinesia measurement as covariate and change from baseline as dependent variable."|ANCOVA|||||1.753|0.392|0.0021
73831467|NCT03881371|147209589|SUPERIORITY||Least-Square Mean|-5.99|STANDARD_ERROR_OF_MEAN|1.447|<|0.0001|TWO_SIDED|95.0|-8.842|-3.141||ANCOVA with treatment and centre as independent factors, baseline UPDRS score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-3.141|-8.842|<.0001
73831468|NCT03881371|147209590|SUPERIORITY||Least-Square Mean|-1.52|STANDARD_ERROR_OF_MEAN|0.51||0.0033|TWO_SIDED|95.0|-2.521|-0.511||ANCOVA with treatment and centre as independent factors, baseline UPDRS part II (ADL) score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-0.511|-2.521|0.0033
73831469|NCT03881371|147209591|SUPERIORITY||Least-Square Mean|-3.8|STANDARD_ERROR_OF_MEAN|0.988||0.0002|TWO_SIDED|95.0|-5.749|-1.856||ANCOVA with treatment and centre as independent factors, baseline UPDRS part III (motor function) score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-1.856|-5.749|0.0002
73831470|NCT03881371|147209592|SUPERIORITY||Median|0.0||||0.015|TWO_SIDED|95.0|0.0|0.0||Analysis was based on the Wilcoxon-Mann-Whitney test stratified by centre.|Wilcoxon (Mann-Whitney)||Non-parametric 95% confidence interval was presented for the treatment difference in CGI-S at each post-baseline visit as reported by the Hodges-Lehmann estimator.|Treatment difference (Safinamide - Placebo)||0.000|0.000|0.0150
73831471|NCT03881371|147209593|SUPERIORITY||Median|0.5||||0.0007|TWO_SIDED|95.0|0.0|1.0||Analysis was based on the Wilcoxon-Mann-Whitney test stratified by centre.|Wilcoxon (Mann-Whitney)||Non-parametric 95% confidence interval was presented for the treatment difference in CGI-C score at each post-baseline visit as reported by the Hodges-Lehmann estimator.|Treatment difference (Safinamide - Placebo)||1.000|0.000|0.0007
73831472|NCT03881371|147209594|SUPERIORITY||Least-Square Mean|-3.36|STANDARD_ERROR_OF_MEAN|1.132||0.0033|TWO_SIDED|95.0|-5.589|-1.128||ANCOVA with treatment and centre as independent factor, baseline Summary Index score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-1.128|-5.589|0.0033
73831473|NCT00933933|147209603|SUPERIORITY_OR_OTHER||Clinical Specificity|99.77|||||TWO_SIDED|95.0|99.62|99.88|||Exact binomial|||||99.88|99.62|
73831474|NCT00933933|147209604|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.31|100.0|||Exact binomial|||||100.00|94.31|
73831475|NCT00933933|147209604|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|99.63|100.0|||Exact binomial|||||100.00|99.63|
73831476|NCT00933933|147209604|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|98.18|100.0|||Exact binomial|||||100.00|98.18|
73831477|NCT00933933|147209605|SUPERIORITY_OR_OTHER||Clinical Specificity|100.0|||||TWO_SIDED|95.0|99.18|100.0|||Exact binomial|||||100.00|99.18|
73831478|NCT00933933|147209605|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.48|100.0|||Exact binomial|||||100.00|94.48|
73831479|NCT00933933|147209606|SUPERIORITY_OR_OTHER||Clinical Specificity|99.83|||||TWO_SIDED|95.0|99.06|100.0|||Exact binomial|||||100.00|99.06|
73831480|NCT00933933|147209606|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.4|100.0|||Exact binomial|||||100.00|94.40|
73896593|NCT03137069|147326498|SUPERIORITY||Least Squares Mean Difference|-0.51||||0.8892|TWO_SIDED|90.0|-6.6|5.58|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||5.58|-6.60|0.8892
73896594|NCT03137069|147326498|SUPERIORITY||Least Squares Mean Difference|-6.43||||0.0717|TWO_SIDED|90.0|-12.29|-0.57|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-0.57|-12.29|0.0717
73896595|NCT03137069|147326498|SUPERIORITY||Least Squares Mean Difference|-9.53||||0.0097|TWO_SIDED|90.0|-15.5|-3.55|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-3.55|-15.50|0.0097
73896596|NCT03137069|147326499|SUPERIORITY|||||||0.1087|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.1087
73896597|NCT03137069|147326499|SUPERIORITY|||||||0.3418|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.3418
73896598|NCT03137069|147326499|SUPERIORITY|||||||0.0459|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.0459
73896599|NCT03137069|147326499|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.0190
73896600|NCT03137069|147326500|SUPERIORITY||Least Squares Mean Difference|-12.88||||0.001|TWO_SIDED|90.0|-18.94|-6.82|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-6.82|-18.94|0.0010
73896601|NCT03137069|147326500|SUPERIORITY||Least Squares Mean Difference|-2.83||||0.4565|TWO_SIDED|90.0|-9.11|3.46|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||3.46|-9.11|0.4565
73896602|NCT03137069|147326500|SUPERIORITY||Least Squares Mean Difference|-5.03||||0.1711|TWO_SIDED|90.0|-11.1|1.03|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||1.03|-11.10|0.1711
73831481|NCT02178956|147209622|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8596|TWO_SIDED|95.0|0.86|1.02||two-sided|Log Rank|stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.|HR is for napabucasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.|||1.02|0.86|0.8596
73831482|NCT02178956|147209623|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9028|TWO_SIDED|95.0|0.85|1.19||two sided|Log Rank|stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.|HR is for napabucuasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.|||1.19|0.85|0.9028
73831483|NCT02178956|147209624|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7359|TWO_SIDED|95.0|0.6|1.44||2-sided|Cochran-Mantel-Haenszel|Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.|Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.|||1.44|0.60|0.7359
73896603|NCT03137069|147326500|SUPERIORITY||Least Squares Mean Difference|-10.76||||0.005|TWO_SIDED|90.0|-16.97|-4.56|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-4.56|-16.97|0.0050
73831484|NCT02178956|147209625|SUPERIORITY||Odds Ratio (OR)|0.93||||0.6555|TWO_SIDED|95.0|0.66|1.3||2-sided|Cochran-Mantel-Haenszel|Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.|Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.|||1.30|0.66|0.6555
73831485|NCT01900314|147209627|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANCOVA|||Repeated measures ANCOVA at 4 weeks with baseline MADRS as co-variate||||0.16
73831486|NCT01900314|147209628|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANCOVA|||Repeated measures ANCOVA with baseline MADRS as co-variate||||0.04
73831487|NCT04225832|147209629|SUPERIORITY||Odds Ratio (OR)|2.51||||0.049|TWO_SIDED|95.0|1.01|6.26||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Logistic|Regression results control for immigration status and length of time in U.S.|Odds ratio is for indicator of intervention arm||Regression results control for immigration status and length of time in U.S.|6.26|1.01|.049
73831488|NCT04225832|147209630|SUPERIORITY||Odds Ratio (OR)|1.06||||0.83|TWO_SIDED|95.0|0.62|1.81||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Logistic|Regression results control for immigration status and length of time in U.S.|Odds ratio is for indicator of intervention arm|||1.81|0.62|.83
73831489|NCT04225832|147209631|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.14|TWO_SIDED|||||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Linear|Regression results control for immigration status, length of time in U.S., and baseline value of the outcome|Slope is adjusted regression coefficient for indicator of intervention arm|"Unlike the observed at any FU primary outcomes which have a single value for each participant, for this outcome we employed a repeated measures style structure with one record for each of up to 3 FU observations. A sandwich estimator (SAS Proc Surveyreg) was employed to account for clustering of observations within participant."||||.14
73831490|NCT03282097|147209632|SUPERIORITY|||||||0.4393|||||||ANCOVA|||||||0.4393
73831491|NCT03282097|147209633|SUPERIORITY|||||||0.2262|||||||ANCOVA|||||||.2262
73831492|NCT03282097|147209634|SUPERIORITY|||||||0.0023|||||||ANCOVA|||||||0.0023
73831493|NCT03282097|147209635|SUPERIORITY|||||||0.6075|||||||Regression, Logistic|||||||0.6075
73831494|NCT03282097|147209636|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<.0001
73831495|NCT03282097|147209637|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
73831496|NCT06001021|147209659|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|-35.55|STANDARD_DEVIATION|17.78||0|TWO_SIDED|90.0|-38.9|-32.19||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||-32.19|-38.90|0.000
73831497|NCT06001021|147209660|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008). Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis.~2008;66(2):150-4. PMID: 18537788"|Mean Difference (Final Values)|23.96|STANDARD_DEVIATION|23.14||0|TWO_SIDED|90.0|19.59|28.32||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||28.32|19.59|0.000
73831498|NCT06001021|147209661|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|86.89|STANDARD_DEVIATION|45.43||0|TWO_SIDED|90.0|78.33|95.46||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||95.46|78.33|0.00
73831499|NCT06001021|147209662|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|22.26|STANDARD_DEVIATION|15.15||0|TWO_SIDED|90.0|19.41|25.12||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||25.12|19.41|0.000
73831500|NCT06001021|147209663|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|16.44|STANDARD_DEVIATION|7.55||0|TWO_SIDED|90.0|15.02|17.87||The significance level is 0.10 with 90% confidence interval|ANCOVA|||Physical Domain of Quality of Life||17.87|15.02|0.000
73831501|NCT06001021|147209663|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|16.6|STANDARD_DEVIATION|7.62||0|TWO_SIDED|90.0|15.16|18.04||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||Psychological Domain of Quality of Life||18.04|15.16|0.000
73831502|NCT06001021|147209663|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|8.26|STANDARD_DEVIATION|3.96||0|TWO_SIDED|90.0|7.52|9.01||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||Social Domain of Quality of Life||9.01|7.52|0.000
73831503|NCT06001021|147209663|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|23.73|STANDARD_DEVIATION|11.07||0|TWO_SIDED|90.0|21.64|25.81||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||||25.81|21.64|0.000
73831504|NCT05473039|147209681|SUPERIORITY|||||||0.2629|||||||Wilcoxon (Mann-Whitney)|||||||0.2629
73831505|NCT05473039|147209682|SUPERIORITY|||||||0.3582|||||||Wilcoxon (Mann-Whitney)|||||||0.3582
73831506|NCT05473039|147209683|SUPERIORITY|||||||0.2187|||||||Wilcoxon (Mann-Whitney)|||||||0.2187
73831507|NCT05473039|147209684|SUPERIORITY|||||||0.3005|||||||Wilcoxon (Mann-Whitney)|||||||0.3005
73831508|NCT05473039|147209685|SUPERIORITY|||||||0.0314|||||||Wilcoxon (Mann-Whitney)|||||||0.0314
73831509|NCT05473039|147209686|SUPERIORITY|||||||0.9214|||||||t-test, 2 sided|||||||0.9214
73831510|NCT05473039|147209686|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||Fasting glucose at the start of COH compared to baseline fasting glucose.||||0.042
73831511|NCT05473039|147209686|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Fasting glucose at the start of COH compared to baseline fasting glucose.||||<0.001
73831512|NCT05473039|147209687|SUPERIORITY|||||||0.59695|||||||t-test, 2 sided|||||||0.59695
73831513|NCT05473039|147209687|SUPERIORITY|||||||0.466503|||||||t-test, 2 sided|||AST at the start of COH compared to baseline AST.||||0.466503
73831514|NCT05473039|147209687|SUPERIORITY|||||||0.959877|||||||t-test, 2 sided|||AST at the start of COH compared to baseline AST.||||0.959877
73831515|NCT05473039|147209688|SUPERIORITY|||||||0.06281|||||||t-test, 2 sided|||||||0.062810
73831516|NCT05473039|147209688|SUPERIORITY|||||||0.417757|||||||t-test, 2 sided|||ALT at the start of COH compared to baseline ALT.||||0.417757
73831517|NCT05473039|147209688|SUPERIORITY|||||||0.968525|||||||t-test, 2 sided|||ALT at the start of COH compared to baseline ALT.||||0.968525
73831518|NCT05473039|147209689|SUPERIORITY|||||||0.686488|||||||t-test, 2 sided|||||||0.686488
73831519|NCT05473039|147209689|SUPERIORITY|||||||0.39512|||||||t-test, 2 sided|||Cholesterol at the start of COH compared to baseline cholesterol.||||0.395120
73831520|NCT05473039|147209689|SUPERIORITY|||||||0.127135|||||||t-test, 2 sided|||Cholesterol at the start of COH compared to baseline cholesterol.||||0.127135
73831521|NCT05473039|147209690|SUPERIORITY|||||||0.257496|||||||t-test, 2 sided|||||||0.257496
73831522|NCT02535312|147209695|OTHER|||||||0.08|||||||Log Rank|||||||0.08
73831523|NCT02535312|147209696|OTHER|||||||0.15|||||||Log Rank|||||||0.15
73831524|NCT04279483|147209704|SUPERIORITY|Linear mixed effects|Slope|-0.64|STANDARD_ERROR_OF_MEAN|1.95||0.74|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.74
73831525|NCT04279483|147209704|SUPERIORITY|Linear mixed effects|Slope|-0.84|STANDARD_ERROR_OF_MEAN|2.12||0.69|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.69
73831526|NCT04279483|147209705|SUPERIORITY|Linear mixed effects|Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.54||0.49|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that cigarettes smoked would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.49
73831527|NCT04279483|147209705|SUPERIORITY|Linear mixed effects|Slope|0.21|STANDARD_ERROR_OF_MEAN|0.59||0.72|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.72
73831528|NCT00879658|147209733|SUPERIORITY||Negative binomial regression model|0.524||||0.148|TWO_SIDED|95.0|0.219|1.257||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.|||An ARR-ratio \<1 favors active treatment.|1.257|0.219|0.148
73831529|NCT00879658|147209733|SUPERIORITY||Negative binomial regression model|0.34||||0.041|TWO_SIDED|95.0|0.121|0.956||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.||||0.956|0.121|0.041
73831530|NCT00879658|147209733|SUPERIORITY||Negative binomial regression model|1.051||||0.899|TWO_SIDED|95.0|0.486|2.273||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.||||2.273|0.486|0.899
73831531|NCT00879658|147209734|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.915||||0.879|TWO_SIDED|95.0|0.288|2.925|||Regression, Logistic|"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."||||2.925|0.288|0.879
73831532|NCT00879658|147209734|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.745||||0.399|TWO_SIDED|95.0|0.484|7.167||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||7.167|0.484|0.399
73831533|NCT00879658|147209734|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.697||||0.454|TWO_SIDED|95.0|0.438|8.296||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||8.296|0.438|0.454
73831534|NCT00879658|147209734|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.509||||0.223|TWO_SIDED|95.0|0.166|1.511||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||1.511|0.166|0.223
73831535|NCT00879658|147209734|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.785||||0.668|TWO_SIDED|95.0|0.253|2.392||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||2.392|0.253|0.668
73831536|NCT00879658|147209735|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.996||||0.178|TWO_SIDED|95.0|0.731|5.669|||Regression, Logistic|Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.||||5.669|0.731|0.178
73831537|NCT00879658|147209735|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|4.12||||0.014|TWO_SIDED|95.0|1.328|14.681||Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic|||||14.681|1.328|0.014
73831538|NCT00879658|147209735|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.266||||0.642|TWO_SIDED|95.0|0.468|3.494||Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic|||||3.494|0.468|0.642
73831539|NCT00879658|147209736|SUPERIORITY||lesion ratio|0.138|||<|0.001|TWO_SIDED|95.0|0.047|0.408|||Regression, Logistic|new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model||Pairwise treatment comparison between different BAF312 dose groups and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.408|0.047|<0.001
73831540|NCT00879658|147209736|SUPERIORITY||lesion ratio|0.307||||0.012|TWO_SIDED|95.0|0.123|0.771||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.771|0.123|0.012
73831541|NCT00879658|147209736|SUPERIORITY||lesion ratio|0.113|||<|0.001|TWO_SIDED|95.0|0.036|0.358||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.358|0.036|<0.001
73831542|NCT00879658|147209736|SUPERIORITY||lesion ratio|0.375||||0.021|TWO_SIDED|95.0|0.163|0.86||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.860|0.163|0.021
73831543|NCT00879658|147209736|SUPERIORITY||lesion ratio|0.478||||0.062|TWO_SIDED|95.0|0.22|1.037||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.037|0.220|0.062
73896604|NCT02720107|147326506|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Naïve T cells||||< 0.0001
73896605|NCT02720107|147326506|SUPERIORITY_OR_OTHER|||||||0.0493||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from study Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Central memory T cells||||0.0493
73896606|NCT02720107|147326506|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Effector memory T cells||||< 0.0001
73896607|NCT02720107|147326506|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Naïve T cells||||< 0.0001
73831544|NCT00879658|147209737|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|Lesion ratio|0.154|||<|0.001|TWO_SIDED|95.0|0.063|0.376|||Regression, Logistic|new lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model||||0.376|0.063|<0.001
73831545|NCT00879658|147209737|SUPERIORITY||lesion ratio|0.228||||0.005|TWO_SIDED|95.0|0.081|0.641||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.641|0.081|0.005
73831546|NCT00879658|147209737|SUPERIORITY||lesion ratio|0.188|||<|0.001|TWO_SIDED|95.0|0.07|0.509||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.509|0.070|<0.001
73831547|NCT00879658|147209738|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.279||||0.002|TWO_SIDED|95.0|0.124|0.628||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.628|0.124|0.002
73831548|NCT00879658|147209738|SUPERIORITY||lesion ratio|0.396||||0.019|TWO_SIDED|95.0|0.182|0.861||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.861|0.182|0.019
73831549|NCT00879658|147209738|SUPERIORITY||lesion ratio|0.154|||<|0.001|TWO_SIDED|95.0|0.059|0.4||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.400|0.059|<0.001
73896608|NCT02720107|147326506|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Central memory T cells||||< 0.0001
73831550|NCT00879658|147209738|SUPERIORITY||lesion ratio|0.454||||0.035|TWO_SIDED|95.0|0.219|0.945||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.945|0.219|0.035
73831551|NCT00879658|147209738|SUPERIORITY||lesion ratio|0.555||||0.087|TWO_SIDED|96.0|0.283|1.09||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.090|0.283|0.087
73831552|NCT00879658|147209739|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.095|||<|0.001|TWO_SIDED|95.0|0.033|0.273||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.273|0.033|<0.001
73831553|NCT00879658|147209739|SUPERIORITY||lesion ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.069|0.47||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.470|0.069|<0.001
73831554|NCT00879658|147209739|SUPERIORITY||lesion ratio|0.173|||<|0.001|TWO_SIDED|95.0|0.069|0.434||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.434|0.069|<0.001
73831555|NCT00879658|147209740|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.259||||0.005|TWO_SIDED|95.0|0.1|0.67||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.670|0.100|0.005
73831556|NCT00879658|147209740|SUPERIORITY||lesion ratio|0.276||||0.005|TWO_SIDED|95.0|0.112|0.676||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.676|0.112|0.005
73831557|NCT00879658|147209740|SUPERIORITY||lesion ratio|0.118|||<|0.001|TWO_SIDED|95.0|0.034|0.409||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.409|0.034|<0.001
73831558|NCT00879658|147209740|SUPERIORITY||lesion ratio|0.683||||0.485|TWO_SIDED|95.0|0.234|1.991||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.991|0.234|0.485
73831559|NCT00879658|147209740|SUPERIORITY||lesion ratio|0.591||||0.142|TWO_SIDED|95.0|0.292|1.193||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.193|0.292|0.142
73831560|NCT00879658|147209741|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.161|||<|0.001|TWO_SIDED|95.0|0.062|0.421||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.421|0.062|<0.001
73831561|NCT00879658|147209741|SUPERIORITY||lesion ratio|0.197||||0.001|TWO_SIDED|95.0|0.074|0.527||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.527|0.074|0.001
73896609|NCT02720107|147326506|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Effector memory T cells||||< 0.0001
73896610|NCT02720107|147326506|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||TH17 central memory cells||||< 0.0001
73896611|NCT00362180|147326510|SUPERIORITY_OR_OTHER|||||||0.7244|TWO_SIDED||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 26.||||0.7244
73831562|NCT00879658|147209741|SUPERIORITY||lesion ratio|0.416||||0.139|TWO_SIDED|95.0|0.13|1.331||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.331|0.130|0.139
73831563|NCT00879658|147209742|SUPERIORITY|||||||0.227||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.227
73831564|NCT00879658|147209742|SUPERIORITY|||||||0.02||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.020
73831565|NCT00879658|147209742|SUPERIORITY|||||||0.001||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.001
73831566|NCT00879658|147209742|SUPERIORITY|||||||0.122||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.122
73831567|NCT00879658|147209742|SUPERIORITY|||||||0.034||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.034
73831568|NCT00879658|147209743|SUPERIORITY|||||||0.335||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.335
73831569|NCT00879658|147209743|SUPERIORITY|||||||0.022||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.022
73831570|NCT00879658|147209743|SUPERIORITY|||||||0.124||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.124
73831571|NCT00879658|147209744|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.129||||0.006|TWO_SIDED|95.0|0.03|0.561||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.561|0.030|0.006
73831572|NCT00879658|147209744|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.159||||0.005|TWO_SIDED|95.0|0.044|0.578||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.578|0.044|0.005
73831573|NCT00879658|147209744|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.052||||0.005|TWO_SIDED|95.0|0.007|0.405||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.405|0.007|0.005
73831574|NCT00879658|147209744|SUPERIORITY||lesion ratio|0.271||||0.019|TWO_SIDED|95.0|0.091|0.807||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.||0.807|0.091|0.019
73831575|NCT00879658|147209744|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.504||||0.169|TWO_SIDED|95.0|0.19|1.337||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||1.337|0.190|0.169
73831576|NCT00879658|147209745|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.214|||<|0.001|TWO_SIDED|95.0|0.091|0.499||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.499|0.091|<0.001
73831577|NCT00879658|147209745|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.24||||0.018|TWO_SIDED|95.0|0.074|0.779||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.779|0.074|0.018
73831578|NCT00879658|147209745|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.231||||0.006|TWO_SIDED|95.0|0.081|0.653||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.653|0.081|0.006
73831579|NCT04530344|147209792|SUPERIORITY||Hazard Ratio (HR)|0.422||||0.0414|TWO_SIDED|95.0|0.18|0.99|||Log Rank|The p-value was based on the log-rank test stratified by randomization stratification factor between treatment and vehicle.||Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.||0.990|0.180|0.0414
73831580|NCT04530344|147209793|SUPERIORITY||Hazard Ratio (HR)|0.316||||0.0003|TWO_SIDED|95.0|0.165|0.606|||Log Rank|The p-value was based on the log-rank test stratified by randomization stratification factor between treatment and vehicle.||Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.||0.606|0.165|0.0003
73831581|NCT01299909|147209866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.35|TWO_SIDED|95.0|0.67|3.51|||Regression, Logistic|||||3.51|0.67|0.35
73831582|NCT01299909|147209867|SUPERIORITY||Mean Difference (Final Values)|4.81||||0.03|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.03
73831583|NCT01299909|147209868|SUPERIORITY||Mean Difference (Final Values)|6.09||||0.02|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.02
73831584|NCT01299909|147209869|SUPERIORITY||Mean Difference (Final Values)|4.96||||0.03|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.03
73831585|NCT03513952|147209875|SUPERIORITY|||||||0.428||||||A one-sided significance level of 0.10 will be considered for the test.|Cochran-Mantel-Haenszel||||Estimations were done separately in each treatment arm; the difference between treatments was not calculated.|||0.428
73831586|NCT03513952|147209876|EQUIVALENCE|"Two-sided Cochran-Mantel-Haenszel test for the CBR was performed, which is used for testing zero effect or equivalence between treatments. A two-sided significance level of 0.05 will be considered for the test."|Risk Difference (RD)|-6.0||||0.702|TWO_SIDED|95.0|-36.3|24.3|||Cochran-Mantel-Haenszel|||||24.3|-36.3|0.702
73831587|NCT01143324|147209883|SUPERIORITY_OR_OTHER||Mean|1.3|STANDARD_DEVIATION|0.5|||TWO_SIDED|95.0|1.2|1.3||||||||1.3|1.2|
73831588|NCT01143324|147209884|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.9|||t-test, 2 sided|||||-2.9|-3.6|<0.0001
73831589|NCT01143324|147209885|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.2|-3.3|||t-test, 2 sided|||||-3.3|-4.2|<0.0001
73831590|NCT01143324|147209886|SUPERIORITY_OR_OTHER||Difference from pre-op mean|0.35|||<|0.0001|TWO_SIDED|95.0|0.3|0.41|||t-test, 2 sided|||||0.41|0.30|<0.0001
73831591|NCT01143324|147209888|SUPERIORITY_OR_OTHER||Percentage|27.0|||||||||||||61/226 patients underwent a rehabilitation programs between 6 and 12 months follow up visit, making it 27.0 % of the total.|||||
73831592|NCT01143324|147209889|SUPERIORITY_OR_OTHER||Percentage|1.2|||||||||||||The rate of additional lumbar spinal surgeries at treated level was 1.2% (3/252) patients.|||||
73831593|NCT01143324|147209890|SUPERIORITY_OR_OTHER||Percentage|1.6|||||||||||||The rate of additional lumbar spinal surgeries at the same level was 1.6% (4/252) patients.|||||
73831594|NCT01143324|147209891|SUPERIORITY_OR_OTHER||Percentage at 12 months|47.6||||||||||||||||||
73831595|NCT01143324|147209893|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-23.0|||<|0.0001|TWO_SIDED|95.0|-25.5|-20.5|||t-test, 2 sided|||||-20.5|-25.5|<0.0001
73831596|NCT01143324|147209894|SUPERIORITY_OR_OTHER||Percentage|42.7||||||||||||||||||
73831597|NCT01143324|147209895|SUPERIORITY_OR_OTHER||Mean|3.2|STANDARD_DEVIATION|2.0||||95.0|2.9|3.4||||||||3.4|2.9|
73831598|NCT02774889|147209907|SUPERIORITY||Rate Ratio|0.72||||0.55|TWO_SIDED|95.0|0.27|2.57|||Fisher Exact|||||2.57|0.27|0.55
73831599|NCT02774889|147209908|SUPERIORITY||Mean Difference (Final Values)|-4.74||||0.001|TWO_SIDED|95.0|-6.61|-2.89|||Fisher Exact|||at 3 months||-2.89|-6.61|0.001
73831600|NCT02774889|147209908|SUPERIORITY||Mean Difference (Final Values)|-4.07||||0.001|TWO_SIDED|95.0|-6.47|-1.68|||Fisher Exact|||at 6 months||-1.68|-6.47|0.001
73831601|NCT02774889|147209909|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.05|TWO_SIDED|95.0|0.0|0.16|||Fisher Exact|||3 months||0.16|0.00|0.05
73831602|NCT02774889|147209909|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0003|TWO_SIDED|95.0|0.07|0.22|||Fisher Exact|||6 months||0.22|0.07|0.0003
73831603|NCT02774889|147209910|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.88|TWO_SIDED|95.0|-0.4|0.44|||Fisher Exact|||3 months||0.44|-0.40|0.88
73831604|NCT02774889|147209910|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.83|TWO_SIDED|95.0|-0.48|0.37|||Fisher Exact|||6 months||0.37|-0.48|0.83
73831605|NCT02774889|147209911|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.36|TWO_SIDED|95.0|-0.2|0.54|||Fisher Exact|||3 months||0.54|-0.20|0.36
73831606|NCT02774889|147209911|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.14|TWO_SIDED|95.0|-0.11|0.77|||Fisher Exact|||6 months||0.77|-0.11|0.14
73831607|NCT02774889|147209912|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.52|TWO_SIDED|95.0|-0.43|0.85|||Fisher Exact|||3 months||0.85|-0.43|0.52
73831608|NCT02774889|147209912|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.36|TWO_SIDED|95.0|-0.31|0.85|||Fisher Exact|||6 months||0.85|-0.31|0.36
73831609|NCT02774889|147209913|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.43|TWO_SIDED|95.0|-0.58|1.32|||Fisher Exact|||3 months||1.32|-0.58|0.43
73831610|NCT02774889|147209913|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.26|TWO_SIDED|95.0|-0.42|1.49|||Fisher Exact|||6 months||1.49|-0.42|0.26
73831611|NCT02774889|147209914|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.16|TWO_SIDED|95.0|-0.09|0.61|||Fisher Exact|||3 months||0.61|-0.09|0.16
73831612|NCT02774889|147209914|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.29|TWO_SIDED|95.0|-0.55|0.17|||Fisher Exact|||6 months||0.17|-0.55|0.29
73831613|NCT02774889|147209916|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.91|TWO_SIDED|95.0|-2.66|2.4|||Fisher Exact|||3 months||2.40|-2.66|0.91
73831614|NCT02774889|147209916|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.8|TWO_SIDED|95.0|-2.79|2.15|||Fisher Exact|||6 months||2.15|-2.79|0.80
73831615|NCT02774889|147209917|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.54|TWO_SIDED|95.0|-1.44|2.64|||Fisher Exact|||3 months||2.64|-1.44|0.54
73831616|NCT02774889|147209917|SUPERIORITY||Mean Difference (Final Values)|1.18||||0.38|TWO_SIDED|95.0|-1.49|3.81|||Fisher Exact|||6 months||3.81|-1.49|0.38
73831617|NCT02774889|147209919|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.04|TWO_SIDED|95.0|0.06|3.71|||Fisher Exact|||Inside Balance||3.71|0.06|0.04
73831618|NCT02774889|147209919|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.05|TWO_SIDED|95.0|-0.02|3.51|||Fisher Exact|||Outside Balance||3.51|-0.02|0.05
73831619|NCT02774889|147209919|SUPERIORITY||Mean Difference (Final Values)|1.86||||0.06|TWO_SIDED|95.0|-0.08|3.81|||Fisher Exact|||Strength||3.81|-0.08|0.06
73831620|NCT02774889|147209920|SUPERIORITY||Mean Difference (Final Values)|1.63||||0.003|TWO_SIDED|95.0|0.54|2.17|||Fisher Exact|||Balance Exercises at 3 months||2.17|0.54|0.003
73831621|NCT02774889|147209920|SUPERIORITY||Mean Difference (Final Values)|1.01||||0.11|TWO_SIDED|95.0|-0.22|2.24|||Fisher Exact|||Balance Exercises at 6 Months||2.24|-0.22|0.11
73831622|NCT02774889|147209921|SUPERIORITY||Mean Difference (Final Values)|1.06||||0.01|TWO_SIDED|95.0|0.23|1.89|||Fisher Exact|||Strength Exercises at 3 months||1.89|0.23|0.01
73831623|NCT02774889|147209921|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.11|TWO_SIDED|95.0|-0.16|1.67|||Fisher Exact|||Strength Exercises at 6 months||1.67|-0.16|0.11
73831624|NCT02774889|147209922|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.38|TWO_SIDED|95.0|-1.3|3.3|||Fisher Exact|||3 months||3.30|-1.30|0.38
73831625|NCT02774889|147209922|SUPERIORITY||Mean Difference (Final Values)|2.6||||0.02|TWO_SIDED|95.0|0.43|4.73|||Fisher Exact|||6 months||4.73|0.43|0.02
73831626|NCT02774889|147209923|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.33|TWO_SIDED|95.0|-0.33|0.97|||Fisher Exact|||3 months||0.97|-0.33|0.33
73831627|NCT02774889|147209923|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.06|TWO_SIDED|95.0|-0.02|1.27|||Fisher Exact|||6 months||1.27|-0.02|0.06
73831628|NCT02774889|147209924|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.06|TWO_SIDED|95.0|-0.03|1.28|||Fisher Exact|||3 months||1.28|-0.03|0.06
73831629|NCT02774889|147209924|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.59|TWO_SIDED|95.0|-0.45|0.81|||Fisher Exact|||||0.81|-0.45|0.59
73831630|NCT04901624|147209927|SUPERIORITY||Slope|1.19|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|0.42|1.97|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Personal + Loss Protection relative to reference group (Personal + Lottery).|||1.97|0.42|0.003
73831631|NCT04901624|147209927|SUPERIORITY||Slope|1.46|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|0.68|2.24|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Family + Loss Protection relative to reference group (Personal + Lottery).|||2.24|0.68|<0.001
73831632|NCT04901624|147209927|SUPERIORITY||Slope|1.11|STANDARD_ERROR_OF_MEAN|0.44||0.01|TWO_SIDED|95.0|0.26|1.96|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Family + Lottery relative to reference group (Personal + Lottery).|||1.96|0.26|0.01
73831633|NCT04901624|147209928|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.35||0.409|TWO_SIDED|95.0|-0.98|0.4|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||0.4|-0.98|0.409
73831634|NCT04901624|147209928|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.098|TWO_SIDED|95.0|-0.09|1.1|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||1.10|-0.09|0.098
73831635|NCT04901624|147209928|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.37||0.982|TWO_SIDED|95.0|-0.71|0.73|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||0.73|-0.71|0.982
73831636|NCT04901624|147209928|SUPERIORITY||Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.177|TWO_SIDED|95.0|-0.67|0.12|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.12|-0.67|0.177
73831637|NCT04901624|147209928|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.21||0.117|TWO_SIDED|95.0|-0.08|0.74|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.74|-0.08|0.117
73831638|NCT04901624|147209928|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.23||0.809|TWO_SIDED|95.0|-0.39|0.5|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.50|-0.39|0.809
73831639|NCT04901624|147209928|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.19||0.847|TWO_SIDED|95.0|-0.34|0.41|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.41|-0.34|0.847
73831640|NCT04901624|147209928|SUPERIORITY||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.2||0.993|TWO_SIDED|95.0|-0.39|0.38|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.38|-0.39|0.993
73831641|NCT04901624|147209928|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.22||0.671|TWO_SIDED|95.0|-0.51|0.33|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.33|-0.51|0.671
73831642|NCT00770809|147209961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED|||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank|||||||0.13
73831643|NCT00770809|147209961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|TWO_SIDED|||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank|||||||0.072
73896612|NCT00362180|147326510|SUPERIORITY_OR_OTHER|||||||0.0513|TWO_SIDED||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 99.||||0.0513
73831644|NCT02469233|147209968|SUPERIORITY||Time by treatment interaction coeff.|-3.18||||0.025|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.025
73831645|NCT02469233|147209968|SUPERIORITY||Time by treatment interaction coeff.|-1.52||||0.28|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.28
73831646|NCT02469233|147209969|SUPERIORITY||time by treatment interaction coeff.|-5.88||||0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.001
73831647|NCT02469233|147209969|SUPERIORITY||maximum likelihood estimation|-3.9||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.03
73831648|NCT02469233|147209970|SUPERIORITY||time by treatment interaction coeff.|-5.55|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||<0.0001
73831649|NCT02469233|147209970|SUPERIORITY||Time by treatment interaction coeff.|-4.92|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||<0.0001
73831650|NCT02469233|147209971|SUPERIORITY||Time by treatment interaction coeff.|-9.14|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||<0.0001
73831651|NCT02469233|147209971|SUPERIORITY||Time by treatment interaction coeff.|-5.37||||0.027|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.027
73831652|NCT02469233|147209972|SUPERIORITY||Time by treatment interaction coeff.|-0.95||||0.32|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.32
73831653|NCT02469233|147209972|SUPERIORITY||Time by treatment interaction coeff.|-1.67||||0.08|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.08
73831654|NCT02469233|147209973|SUPERIORITY||Time by treatment interaction coeff.|-0.09||||0.72|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.72
73831655|NCT02469233|147209973|SUPERIORITY||Time by treatment interaction coeff.|-0.08||||0.74|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.74
73831656|NCT02469233|147209974|SUPERIORITY||Time by treatment interaction coeff.|-2.46||||0.73|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.73
73831657|NCT02469233|147209974|SUPERIORITY||Time by treatment interaction coeff.|-17.52||||0.02|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.02
73831658|NCT02469233|147209975|SUPERIORITY||Time by treatment interaction coeff.|5.68||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.03
73831659|NCT02469233|147209975|SUPERIORITY||Time by treatment interaction coeff.|5.89||||0.03|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.03
73831660|NCT02469233|147209975|SUPERIORITY||Time by treatment interaction coeff.|-1.45||||0.43|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.43
73831661|NCT02469233|147209975|SUPERIORITY||Time by treatment interaction coeff.|-1.55||||0.4|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.40
73831662|NCT02469233|147209976|SUPERIORITY||Time by treatment interaction coeff.|-12.68||||0.59|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.59
73831663|NCT02469233|147209976|SUPERIORITY||Time by treatment interaction coeff.|-28.33||||0.22|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.22
73831664|NCT02469233|147209976|SUPERIORITY||Time by treatment interaction coeff.|4.65||||0.8|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.80
73831665|NCT02469233|147209976|SUPERIORITY||Time by treatment interaction coeff.|-7.57||||0.68|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.68
73831666|NCT02469233|147209977|SUPERIORITY||Time by treatment interaction coeff.|-76.85||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.34
73831667|NCT02469233|147209977|SUPERIORITY||Time by treatment interaction coeff.|-87.15||||0.28|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.28
73831668|NCT02469233|147209977|SUPERIORITY||Time by treatment interaction coeff.|-0.15||||0.18|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.18
73831669|NCT02469233|147209977|SUPERIORITY||Time by treatment interaction coeff.|-0.27||||0.02|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.02
73831670|NCT02469233|147209978|SUPERIORITY||Time by treatment interaction coeff.|-7.19||||0.09|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.09
73831671|NCT02469233|147209978|SUPERIORITY||Time by treatment interaction coeff.|-1.13||||0.79|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome.||Treatment effect on change from pre to 6-month follow-up||||0.79
73831672|NCT02469233|147209979|SUPERIORITY||Time by treatment interaction coeff.|0.16||||0.46|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome,||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.46
73831673|NCT02469233|147209979|SUPERIORITY||Time by treatment interaction coeff.|-0.34||||0.1|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.10
73831674|NCT02469233|147209980|SUPERIORITY||Time by treatment interaction coeff.|0.91||||0.002|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.002
73831675|NCT02469233|147209980|SUPERIORITY||Time by treatment interaction coeff.|0.64||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up.||||0.03
73831676|NCT02469233|147209981|SUPERIORITY||Time by treatment interaction coeff.|24.85||||0.23|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Means of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.23
73831677|NCT02469233|147209981|SUPERIORITY||Time by treatment interaction coeff.|34.31||||0.09|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Means of total sleep time: Treatment effect on change from pre to 6-month follow-up||||0.09
73831678|NCT02469233|147209981|SUPERIORITY||Time by treatment interaction coeff.|-19.9||||0.19|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Variability of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.19
73831679|NCT02469233|147209981|SUPERIORITY||Time by treatment interaction coeff.|-1.76||||0.91|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Variability of Total sleep time: Treatment effect on change from pre to 6-month follow-up||||0.91
73831680|NCT02469233|147209982|SUPERIORITY||Time by treatment interaction coeff.|-39.33||||0.04|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.04
73831681|NCT02469233|147209982|SUPERIORITY||Time by treatment interaction coeff.|-28.56||||0.13|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.13
73831682|NCT02469233|147209982|SUPERIORITY||Time by treatment interaction coeff.|-17.57||||0.21|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.21
73831683|NCT02469233|147209982|SUPERIORITY||Time by treatment interaction coeff.|-16.05||||0.25|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.25
73831684|NCT02469233|147209983|SUPERIORITY||Time by treatment interaction coeff.|-0.55||||0.1|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Bedtime (BT) mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.10
73831685|NCT02469233|147209983|SUPERIORITY||Time by treatment interaction coeff.|-0.71||||0.04|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT mean: Treatment effect on change from pre to 6-month follow-up.||||0.04
73831686|NCT02469233|147209983|SUPERIORITY||Time by treatment interaction coeff.|-0.31||||0.2|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.20
73831687|NCT02469233|147209983|SUPERIORITY||Time by treatment interaction coeff.|-0.45||||0.07|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT variability: Treatment effect on change from pre to 6-month follow-up.||||0.07
73831688|NCT02469233|147209984|SUPERIORITY||Time by treatment interaction coeff.|-0.33||||0.39|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.39
73831689|NCT02469233|147209984|SUPERIORITY||Time by treatment interaction coeff.|-0.02||||0.96|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT mean: Treatment effect on change from pre to 6-month follow-up.||||0.96
73831690|NCT02469233|147209984|SUPERIORITY||Time by treatment interaction coeff.|-0.39||||0.047|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.047
73831691|NCT02469233|147209984|SUPERIORITY||Time by treatment interaction coeff.|0.2||||0.3|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT variability: Treatment effect on change from pre to 6-month follow-up.||||0.30
73831692|NCT02469233|147209985|SUPERIORITY||Time by treatment interaction coeff.|-4.42||||0.66|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.66
73831693|NCT02469233|147209985|SUPERIORITY||Time by treatment interaction coeff.|-13.34||||0.19|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.19
73831694|NCT02469233|147209985|SUPERIORITY||Time by treatment interaction coeff.|-0.05||||0.77|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.77
73831695|NCT02469233|147209985|SUPERIORITY||Time by treatment interaction coeff.|-0.22||||0.2|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.20
73831696|NCT03474107|147210005|SUPERIORITY||Stratified Hazard Ratio|0.702||||0.00142|TWO_SIDED|95.0|0.556|0.886||Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P-value of overall survival is ≤ the predetermined 1-sided significance level of 0.00679 based on the number of observed deaths.|Stratified Log rank||Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.|||0.886|0.556|0.00142
73831697|NCT03474107|147210006|SUPERIORITY||Stratified Hazard Ratio|0.615|||<|1e-05|TWO_SIDED|95.0|0.505|0.748||Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P value of PFS is ≤ the predetermined 1-sided significance level of 0.02189 based on the number of observed PFS events.|Stratified Log Rank||Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.|||0.748|0.505|<0.00001
73831698|NCT03474107|147210007|SUPERIORITY||||||<|0.001||||||"Stratification factors were ECOG PS, Region and Liver Metastasis."|Stratified Cochran-Mantel-Haenszel|||||||<0.001
73831699|NCT03474107|147210008|SUPERIORITY||||||<|0.001||||||Stratification factors were ECOG PS, Region and Liver Metastasis.|Stratified Cochran-Mantel-Haenszel|||||||<0.001
73831700|NCT02127671|147210014|SUPERIORITY||Mean Difference (Net)|-12.7|||||TWO_SIDED|95.0|-22.9|-2.5||||||||-2.5|-22.9|
73831701|NCT02127671|147210016|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.7|0.9||||||||0.9|-0.7|
73831702|NCT02127671|147210020|SUPERIORITY||Mean Difference (Net)|-7.6|||||TWO_SIDED|95.0|-17.6|2.4||||||||2.4|-17.6|
73831703|NCT02127671|147210021|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.3|0.2||||||||0.2|-0.3|
73831704|NCT02127671|147210022|SUPERIORITY||Mean Difference (Net)|-10.5|||||TWO_SIDED|95.0|-18.4|-2.6||||||||-2.6|-18.4|
73831705|NCT02127671|147210023|SUPERIORITY||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-5.1|1.5||||||systolic||1.5|-5.1|
73831706|NCT02127671|147210023|SUPERIORITY||Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-3.8|0.5||||||diastolic||0.5|-3.8|
73831707|NCT02127671|147210025|SUPERIORITY||Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-13.3|4.7||||||||4.7|-13.3|
73831708|NCT02127671|147210026|SUPERIORITY||Mean Difference (Net)|-5.4|||||TWO_SIDED|95.0|-12.7|2.0||||||||2.0|-12.7|
73831709|NCT02127671|147210027|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-1.8|3.8||||||||3.8|-1.8|
73831710|NCT02127671|147210028|SUPERIORITY||Mean Difference (Net)|8.1|||||TWO_SIDED|95.0|-13.4|29.6||||||||29.6|-13.4|
73831711|NCT00764517|147210037|OTHER||Hazard Ratio (HR)|0.33||||0.002|TWO_SIDED|95.0|0.16|0.69|||Log Rank|||||0.69|0.16|0.002
73831712|NCT00764517|147210038|OTHER||Hazard Ratio (HR)|0.42||||0.011|TWO_SIDED|95.0|0.21|0.84|||Log Rank|||||0.84|0.21|0.011
73831713|NCT01433913|147210042|OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
73831714|NCT01433913|147210043|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
73831715|NCT01433913|147210044|OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
73831716|NCT01433913|147210045|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
73831717|NCT01433913|147210046|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
73831718|NCT01433913|147210050|OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
73831719|NCT01433913|147210051|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
73831720|NCT01433913|147210052|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
73831721|NCT01433913|147210053|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
73831722|NCT01433913|147210054|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
73831723|NCT03813654|147210066|OTHER|Mixed model analysis with post-hoc tests.|Mean Difference (Final Values)|90.0|STANDARD_DEVIATION|68.7|<|0.05|TWO_SIDED|||||A priori threshold was \<0.05.|Mixed Models Analysis||This is the difference between the control and 8-h Free Sleep Group.|||||<0.05
73831724|NCT03813654|147210071|SUPERIORITY|||||||0.09||||||The groups had unequal variances, so we adjusted for unequal variances when doing the t-test. The a priori threshold for statistical significance was p\<0.05.|t-test, 1 sided|Adjusted for unequal variances between the two groups.||We compared the PVT taken at the start of the final night shift between Group B and those in Group C who slept in the morning and had complete data. Our hypothesis was that Group B would have faster RTs.||||0.09
73831725|NCT01208051|147210082|SUPERIORITY|||||||0.26||||||p-value is stratified by randomization factors.|Log Rank|The conditional power was 7.8%, reaching the futility boundary of \<15%. Patients on the combination arm were then crossed over to cediranib alone.||||||0.26
73831726|NCT01208051|147210083|SUPERIORITY|||||||0.36|||||||Log Rank|||||||0.36
73831727|NCT01208051|147210085|SUPERIORITY|||||||0.8|||||||Log Rank|||||||0.80
73831728|NCT01208051|147210086|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
73831729|NCT02107898|147210091|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.1|||<|0.0001|TWO_SIDED|95.0|-68.5|-59.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-59.8|-68.5|<0.0001
73831730|NCT02107898|147210092|SUPERIORITY_OR_OTHER||LS Mean Difference|-65.3|||<|0.0001|TWO_SIDED|95.0|-69.4|-61.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-61.3|-69.4|<0.0001
73831731|NCT02107898|147210093|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.5|||<|0.0001|TWO_SIDED|95.0|-65.3|-57.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-57.7|-65.3|<0.0001
73831732|NCT02107898|147210094|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.1|||<|0.0001|TWO_SIDED|95.0|-65.8|-58.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-58.3|-65.8|<0.0001
73831733|NCT02107898|147210095|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.3|||<|0.0001|TWO_SIDED|95.0|-57.5|-49.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.1|-57.5|<0.0001
73831734|NCT02107898|147210096|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.8|||<|0.0001|TWO_SIDED|95.0|-57.8|-49.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.8|-57.8|<0.0001
73831735|NCT02107898|147210097|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.5|||<|0.0001|TWO_SIDED|95.0|-61.5|-53.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.5|-61.5|<0.0001
73831736|NCT02107898|147210098|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.6|||<|0.0001|TWO_SIDED|95.0|-62.3|-54.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.8|-62.3|<0.0001
73831737|NCT02107898|147210099|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.5|||<|0.0001|TWO_SIDED|95.0|-44.6|-38.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-38.4|-44.6|<0.0001
73831738|NCT02107898|147210100|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-54.9|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.6|-54.9|<0.0001
73831739|NCT02107898|147210101|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.5|||<|0.0001|TWO_SIDED|95.0|-57.9|-51.1|||Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.1|-57.9|<0.0001
73831740|NCT02107898|147210102|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-41.7|-36.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.4|-41.7|<0.0001
73831741|NCT02107898|147210103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|552.1|||<|0.0001|TWO_SIDED|95.0|105.6|2886.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||2886.8|105.6|<0.0001
73831742|NCT02107898|147210104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1367.8|||<|0.0001|TWO_SIDED|95.0|137.8|13578.3||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||13578.3|137.8|<0.0001
73831743|NCT02107898|147210105|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-36.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.0|-48.0|<0.0001
73831744|NCT02107898|147210106|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-30.9|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.1|-30.9|<0.0001
73831745|NCT02107898|147210107|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8||||0.002|TWO_SIDED|95.0|2.1|9.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.4|2.1|0.0020
73831746|NCT02107898|147210108|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0||||0.0382|TWO_SIDED|95.0|0.2|7.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.9|0.2|0.0382
73831747|NCT02107898|147210109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.4|||<|0.0001|TWO_SIDED|95.0|-47.0|-35.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35.7|-47.0|<0.0001
73831748|NCT02107898|147210110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.5||||0.0007|TWO_SIDED|95.0|-24.4|-6.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.6|-24.4|0.0007
73831749|NCT02107898|147210111|SUPERIORITY_OR_OTHER||LS Mean Difference|6.5|||<|0.0001|TWO_SIDED|95.0|3.7|9.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.3|3.7|<0.0001
73831750|NCT02107898|147210112|SUPERIORITY_OR_OTHER||LS Mean Difference|6.3|||<|0.0001|TWO_SIDED|95.0|3.6|9.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.0|3.6|<0.0001
73831751|NCT00770367|147210142|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED||||||t-test, 2 sided|||A twosample comparison of mean treatment differences conducted using a pre-determined significance level of alpha level \<0.05. 2 a comparison of means for NOx levels at 12 weeks b/w groups. 3 on the change F2-isoprostanes at 12 weeks b/w groups.||||.37
73831752|NCT00920816|147210148|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.767|||||TWO_SIDED|95.0|0.559|1.053||||||First-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1).||1.053|0.559|
73831753|NCT00920816|147210149|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.731|||||TWO_SIDED|95.0|0.506|1.058||||||Second-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1) and prior treatment (sunitinib versus cytokine-containing regimen).||1.058|0.506|
73831754|NCT01932606|147210219|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||||||0.0003
73831755|NCT01932606|147210220|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure.||||0.0003
73831756|NCT01932606|147210220|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure.||||0.01
73831757|NCT01932606|147210220|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure.||||0.002
73831758|NCT01932606|147210220|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Comparison between the 2 arms for change in PCWP.||||<0.0001
73831759|NCT01932606|147210221|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
73831760|NCT01932606|147210222|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.||||0.11
73831761|NCT01932606|147210222|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean blood pressure.||||0.2
73831762|NCT01932606|147210223|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PVR.||||0.7
73831763|NCT01932606|147210224|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery compliance.||||0.1
73831764|NCT01932606|147210225|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in SVR.||||0.3
73831765|NCT01932606|147210226|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in LVSW.||||0.3
73831766|NCT01932606|147210227|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in VO\_2.||||0.8
73831767|NCT01932606|147210228|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for arteriovenous oxygen content difference.||||0.1
73831768|NCT01932606|147210229|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output.||||0.4
73831769|NCT01932606|147210230|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume.||||0.4
73831770|NCT01932606|147210231|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure (exercise).||||0.0002
73831771|NCT01932606|147210231|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure (exercise).||||0.01
73831772|NCT01932606|147210231|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure (exercise).||||0.0002
73831773|NCT01932606|147210231|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PCWP (exercise).||||0.0002
73831774|NCT01932606|147210232|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in heart rate.||||0.3
73831775|NCT01932606|147210233|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.||||0.2
73831776|NCT01932606|147210233|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in diastolic blood pressure.||||0.05
73831777|NCT01932606|147210234|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PVR after study drug (exercise)||||0.3
73831778|NCT01932606|147210235|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PA compliance after study drug (exercise)||||0.3
73831779|NCT01932606|147210236|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in SVR after study drug (exercise).||||0.007
73831780|NCT01932606|147210237|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in LVSW after study drug (exercise)||||0.0003
73831781|NCT01932606|147210238|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in oxygen consumption (VO\_2) after study drug (exercise).||||0.02
73831782|NCT01932606|147210239|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in arteriovenous oxygen difference after study drug (exercise).||||0.6
73831783|NCT01932606|147210240|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output after study drug (exercise).||||0.002
73831784|NCT01932606|147210241|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume after study drug (exercise).||||0.0002
73831785|NCT01532089|147210245|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.39|TWO_SIDED|95.0|0.5|1.31|||Log Rank|Comparisons of PFS between arms were conducted using a stratified log-rank test.||||1.31|0.50|0.39
73831786|NCT01532089|147210246|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.33|TWO_SIDED|95.0|0.71|2.81|||Log Rank|||||2.81|0.71|0.33
73831787|NCT01532089|147210247|SUPERIORITY|||||||0.81|||||||Chi-squared|||||||0.81
73831788|NCT01995201|147210255|OTHER|||||||0.5231|||||||Chi-squared|||||||0.5231
73831789|NCT03329001|147210298|OTHER||Ratio of geometric least square mean|0.911|||||TWO_SIDED|90.0|0.855|0.9706|||||Relative bioavailability (AUC\[tablet\]/AUC\[capsule\]) was assessed using analysis of variance (ANOVA) model accounting for sequence, participants nested with sequences, period and treatment.|||0.9706|0.8550|
73831790|NCT03329001|147210299|OTHER||Ratio of geometric least square mean|0.9216|||||TWO_SIDED|90.0|0.8631|0.9841|||||Relative bioavailability (AUC\[tablet\]/AUC\[capsule\]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.|||0.9841|0.8631|
73831791|NCT03329001|147210300|OTHER||Ratio of geometric least square mean|0.9483|||||TWO_SIDED|90.0|0.8489|1.0593|||||Relative bioavailability (Cmax\[tablet\]/Cmax\[capsule\]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.|||1.0593|0.8489|
73831792|NCT03329001|147210305|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-t|Ratio of geometric least square mean|0.9594|||||TWO_SIDED|90.0|0.9199|1.0006|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||1.0006|0.9199|
73831793|NCT03329001|147210306|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-inf|Ratio of geometric least square mean|0.9566|||||TWO_SIDED|90.0|0.9164|0.9986|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||0.9986|0.9164|
73831794|NCT03329001|147210307|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for Cmax|Ratio of geometric least square mean|0.9619|||||TWO_SIDED|90.0|0.9124|1.014|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||1.0140|0.9124|
73831795|NCT03329001|147210312|OTHER||Ratio of geometric least square mean|1.3154|||||TWO_SIDED|90.0|1.1742|1.4735|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.4735|1.1742|
73831796|NCT03329001|147210313|OTHER||Ratio of geometric least square mean|1.2771|||||TWO_SIDED|90.0|1.1537|1.4137|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.4137|1.1537|
73831797|NCT03329001|147210314|OTHER||Ratio of geometric least square mean|1.1129|||||TWO_SIDED|90.0|0.9408|1.3164|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.3164|0.9408|
73831798|NCT00622518|147210328|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0||||P value is based on rating\*group interaction term|linear mixed model|||||||.002
73831799|NCT03769493|147210331|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||< .001
73831800|NCT03769493|147210332|SUPERIORITY|||||||0.875|||||||t-test, 2 sided|||||||.875
73831801|NCT01104766|147210385|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.0044|TWO_SIDED|95.0|-10.1|-1.9|||ANCOVA|||||-1.9|-10.1|0.0044
73831802|NCT01104766|147210385|SUPERIORITY||Mean Difference (Final Values)|-8.8|||<|0.0001|TWO_SIDED|95.0|-12.9|-4.7|||ANCOVA|||||-4.7|-12.9|<0.0001
73831803|NCT01104766|147210385|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.0008|TWO_SIDED|95.0|-11.0|-2.9|||ANCOVA|||||-2.9|-11.0|0.0008
73831804|NCT01104766|147210386|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0004
73831805|NCT01104766|147210386|SUPERIORITY||Median Difference (Final Values)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.0001
73831806|NCT01104766|147210386|SUPERIORITY||Median Difference (Final Values)|-0.4||||0.0001|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0001
73831807|NCT03034967|147210486|OTHER|Emax|Median Posterior Difference|0.08|||||TWO_SIDED|90.0|0.0|0.66|||||Median posterior difference, 90 percent (%) credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.66|0.00|
73831808|NCT03034967|147210486|OTHER|Emax|Median Posterior Difference|0.61|||||TWO_SIDED|90.0|0.0|1.52|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||1.52|0.00|
73831809|NCT03034967|147210486|OTHER|Emax|Median Posterior Difference|1.25|||||TWO_SIDED|90.0|0.43|1.97|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||1.97|0.43|
73831810|NCT03034967|147210486|OTHER|Emax|Median Posterior Difference|1.34|||||TWO_SIDED|90.0|0.72|2.03|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||2.03|0.72|
73831811|NCT03034967|147210486|OTHER|Emax|Median Posterior Difference|1.38|||||TWO_SIDED|90.0|0.79|2.07|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||2.07|0.79|
73831812|NCT03034967|147210487|OTHER|Emax|Median Posterior Difference|0.09|||||TWO_SIDED|90.0|0.0|0.42|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.42|0.00|
73831813|NCT03034967|147210487|OTHER|Emax|Median Posterior Difference|0.43|||||TWO_SIDED|90.0|0.0|0.87|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||0.87|0.00|
73831814|NCT03034967|147210487|OTHER|Emax|Median Posterior Difference|0.68|||||TWO_SIDED|90.0|0.23|1.08|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||1.08|0.23|
73831815|NCT03034967|147210487|OTHER|Emax|Median Posterior Difference|0.72|||||TWO_SIDED|90.0|0.37|1.1|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||1.10|0.37|
73831816|NCT03034967|147210487|OTHER|Emax|Median Posterior Difference|0.73|||||TWO_SIDED|90.0|0.4|1.12|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||1.12|0.40|
73831817|NCT03034967|147210488|OTHER|Emax|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|0.0|0.16|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.16|0.00|
73831818|NCT03034967|147210488|OTHER|Emax|Median Posterior Difference|0.12|||||TWO_SIDED|90.0|0.0|0.43|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||0.43|0.00|
73831819|NCT03034967|147210488|OTHER|Emax|Median Posterior Difference|0.38|||||TWO_SIDED|90.0|0.04|0.61|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||0.61|0.04|
73831820|NCT03034967|147210488|OTHER|Emax|Median Posterior Difference|0.42|||||TWO_SIDED|90.0|0.21|0.64|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||0.64|0.21|
73831821|NCT03034967|147210488|OTHER|Emax|Median Posterior Difference|0.45|||||TWO_SIDED|90.0|0.26|0.66|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||0.66|0.26|
73831822|NCT03034967|147210489|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.21|0.23|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|Log-linear model.||0.23|-0.21|
73831823|NCT03034967|147210489|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.23|0.25|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|Log-linear model||0.25|-0.23|
73831824|NCT03034967|147210489|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.27|0.29|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|Log-linear model||0.29|-0.27|
73831825|NCT03034967|147210489|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.28|0.3|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|Log-linear model||0.30|-0.28|
73831826|NCT03034967|147210489|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.29|0.31|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|Log-linear model||0.31|-0.29|
73831827|NCT03034967|147210496|OTHER||Odds Ratio (OR)|1.71||||0.089|TWO_SIDED|90.0|1.02|2.86||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||2.86|1.02|0.089
73831828|NCT03034967|147210496|OTHER||Odds Ratio (OR)|1.05||||0.881|TWO_SIDED|90.0|0.62|1.79||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||1.79|0.62|0.881
73831829|NCT03034967|147210496|OTHER||Odds Ratio (OR)|0.87||||0.674|TWO_SIDED|90.0|0.51|1.48||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||1.48|0.51|0.674
73831830|NCT03034967|147210496|OTHER||Odds Ratio (OR)|0.92||||0.804|TWO_SIDED|90.0|0.54|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||1.58|0.54|0.804
73831831|NCT03034967|147210496|OTHER||Odds Ratio (OR)|1.01||||0.987|TWO_SIDED|90.0|0.59|1.71||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||1.71|0.59|0.987
73831832|NCT03034967|147210498|OTHER||Median Posterior Hazard Ratio|1.2|||||TWO_SIDED|90.0|0.5|2.6|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX versus (vs.) Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted Forced Expiratory Volume in one second (FEV1)at Screening.|2.6|0.5|
73831833|NCT03034967|147210498|OTHER||Median Posterior Hazard Ratio|1.0|||||TWO_SIDED|90.0|0.4|2.4|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.4|0.4|
73831834|NCT03034967|147210498|OTHER||Median Posterior Hazard Ratio|1.4|||||TWO_SIDED|90.0|0.6|3.2|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|3.2|0.6|
73831835|NCT03034967|147210498|OTHER||Median Posterior Hazard Ratio|2.0|||||TWO_SIDED|90.0|1.0|4.3|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|4.3|1.0|
73831836|NCT03034967|147210498|OTHER||Median Posterior Hazard Ratio|2.0|||||TWO_SIDED|90.0|0.9|4.5|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|4.5|0.9|
73831837|NCT03034967|147210501|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.5|||||TWO_SIDED|90.0|1.0|2.2|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator %predicted FEV1 at Screening.|2.2|1.0|
73831838|NCT03034967|147210501|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.8|1.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|1.7|0.8|
73831839|NCT03034967|147210501|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.7|1.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|1.6|0.7|
73831840|NCT03034967|147210501|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.4|||||TWO_SIDED|90.0|1.0|2.1|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.1|1.0|
73831841|NCT03034967|147210501|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.6|||||TWO_SIDED|90.0|1.1|2.3|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.3|1.1|
73831842|NCT03034967|147210502|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||TWO_SIDED|90.0|0.7|5.5|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.5|0.7|
73831843|NCT03034967|147210502|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.9|||||TWO_SIDED|90.0|0.7|5.8|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.8|0.7|
73831844|NCT03034967|147210502|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||TWO_SIDED|90.0|0.7|5.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.6|0.7|
73831845|NCT03034967|147210502|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|2.3|||||TWO_SIDED|90.0|0.9|6.9|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|6.9|0.9|
73831846|NCT03034967|147210502|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.2|2.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.7|0.2|
73831847|NCT03034967|147210505|OTHER||Odds Ratio (OR)|1.51||||0.208|TWO_SIDED|90.0|0.88|2.59||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||2.59|0.88|0.208
73831848|NCT03034967|147210505|OTHER||Odds Ratio (OR)|1.27||||0.482|TWO_SIDED|90.0|0.73|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||2.20|0.73|0.482
73831849|NCT03034967|147210505|OTHER||Odds Ratio (OR)|1.47||||0.239|TWO_SIDED|90.0|0.86|2.53||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||2.53|0.86|0.239
73831850|NCT03034967|147210505|OTHER||Odds Ratio (OR)|1.31||||0.426|TWO_SIDED|90.0|0.75|2.26||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||2.26|0.75|0.426
73831851|NCT03034967|147210505|OTHER||Odds Ratio (OR)|0.9||||0.763|TWO_SIDED|90.0|0.52|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||1.58|0.52|0.763
73831852|NCT03034967|147210507|OTHER||Odds Ratio (OR)|1.01||||0.973|TWO_SIDED|90.0|0.58|1.76||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||1.76|0.58|0.973
73831853|NCT03034967|147210507|OTHER||Odds Ratio (OR)|0.93||||0.825|TWO_SIDED|90.0|0.53|1.63||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||1.63|0.53|0.825
73831854|NCT03034967|147210507|OTHER||Odds Ratio (OR)|0.95||||0.887|TWO_SIDED|90.0|0.55|1.66||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||1.66|0.55|0.887
73831855|NCT03034967|147210507|OTHER||Odds Ratio (OR)|1.21||||0.567|TWO_SIDED|90.0|0.69|2.13||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||2.13|0.69|0.567
73831856|NCT03034967|147210507|OTHER||Odds Ratio (OR)|1.26||||0.501|TWO_SIDED|90.0|0.72|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||2.20|0.72|0.501
73831857|NCT00157755|147210590|SUPERIORITY_OR_OTHER|||||||0.215||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.215
73831858|NCT00157755|147210590|SUPERIORITY_OR_OTHER|||||||1||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||1.0
73831859|NCT00157755|147210591|SUPERIORITY_OR_OTHER|||||||0.903||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.903
73831860|NCT00157755|147210591|SUPERIORITY_OR_OTHER|||||||0.932||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.932
73831861|NCT00157755|147210592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"||||<0.001
73831862|NCT00157755|147210592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"||||<0.001
73831863|NCT00157755|147210593|SUPERIORITY_OR_OTHER|||||||0.014||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"||||0.014
73831864|NCT00157755|147210593|SUPERIORITY_OR_OTHER||||||<|0.001||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"||||<0.001
73831865|NCT00157755|147210594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"||||<0.001
73831866|NCT00157755|147210594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"||||<0.001
73831867|NCT00157755|147210595|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"||||<0.001
73831868|NCT00157755|147210595|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"||||0.043
73831869|NCT00157755|147210596|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"||||0.009
73831870|NCT00157755|147210596|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"||||0.001
73831871|NCT00157755|147210597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||<0.001
73831872|NCT00157755|147210597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||<0.001
73831873|NCT00157755|147210598|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||0.016
73831874|NCT00157755|147210598|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||0.236
73831875|NCT05523297|147210607|NON_INFERIORITY|The test for non-inferiority was one-sided Farrington-Manning score test with non-inferiority margin 10% at a significance level of 2.5%. If the 95% CI for treatment effect not only lay above -10% (the non-inferiority margin) but also above 0, then there was evidence of superiority.|percent difference|17.55|||<|0.0001|TWO_SIDED|95.0|8.7|26.4|||Two-sided Farrington-Manning score test.||Difference between Octaplex and FP arms for effectiveness|||26.4|8.7|<0.0001
73831876|NCT05523297|147210608|OTHER||Odds Ratio (OR)|1.91||||0.0022|TWO_SIDED|95.0|1.26|2.88|||Regression, Logistic|||||2.88|1.26|0.0022
73831877|NCT05523297|147210609|OTHER||Least Squares Mean Difference|-170.73|||<|0.0001|TWO_SIDED|95.0|-250.24|-91.22|||ANOVA|||12 hours after chest closure||-91.22|-250.24|<0.0001
73831878|NCT05523297|147210609|OTHER||Least Squares Mean Difference|-231.92|||<|0.0001|TWO_SIDED|95.0|-338.17|-125.67|||ANOVA|||24 hours after chest closure||-125.67|-338.17|<0.0001
73831879|NCT05523297|147210610|OTHER||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.97|5.15|||Regression, Logistic|||Within 24 hours after IMP start||5.15|1.97|<0.0001
73831880|NCT05523297|147210610|OTHER||Odds Ratio (OR)|2.88|||<|0.0001|TWO_SIDED|95.0|1.83|4.52|||Regression, Logistic|||Within 24 hours after surgery start||4.52|1.83|<0.0001
73831881|NCT05523297|147210610|OTHER||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.97|5.15|||Regression, Logistic|||Within 24 hours after CPB end||5.15|1.97|<0.0001
73831882|NCT05523297|147210611|OTHER||Mean ratio|0.48|||<|0.0001|TWO_SIDED|95.0|0.41|0.57|||Counting regression|||||0.57|0.41|<0.0001
73831883|NCT05523297|147210612|OTHER||Mean ratio|0.71||||0.0015|TWO_SIDED|95.0|0.57|0.88|||Counting regression|||||0.88|0.57|0.0015
73831884|NCT05523297|147210613|OTHER||Mean ratio|0.61||||0.001|TWO_SIDED|95.0|0.46|0.82|||Counting regression|||During the first 24 hours after IMP start||0.82|0.46|0.0010
73831885|NCT05523297|147210613|OTHER||Mean ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.45|0.76|||Counting regression|||During the first 7 days after IMP start||0.76|0.45|<0.0001
73831886|NCT05523297|147210614|OTHER||Mean ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.03|0.06|||Negative binomial regression|||FP including IMP (During the first 24 hours after IMP start)||0.06|0.03|<0.0001
73831887|NCT05523297|147210614|OTHER||Mean ratio|0.85||||0.8522|TWO_SIDED|95.0|0.15|4.82|||Negative binomial regression|||FP excluding IMP (During the first 24 hours after IMP start)||4.82|0.15|0.8522
73831888|NCT05523297|147210614|OTHER||Mean ratio|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||Negative binomial regression|||RBCs (During the first 24 hours after IMP start)||0.68|0.40|<0.0001
73831889|NCT05523297|147210614|OTHER||Mean ratio|0.65||||0.0169|TWO_SIDED|95.0|0.45|0.92|||Negative binomial regression|||Platelets (During the first 24 hours after IMP start)||0.92|0.45|0.0169
73831890|NCT05523297|147210614|OTHER||Mean ratio|0.57||||0.3288|TWO_SIDED|95.0|0.18|1.76|||Negative binomial regression|||Cryoprecipitate (During the first 24 hours after IMP start)||1.76|0.18|0.3288
73831891|NCT05523297|147210614|OTHER||Mean ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.04|0.06|||Negative binomial regression|||FP including IMP (During the first 7 days after IMP start)||0.06|0.04|<0.0001
73831892|NCT05523297|147210614|OTHER||Mean ratio|0.63||||0.5439|TWO_SIDED|95.0|0.14|2.84|||Negative binomial regression|||FP excluding IMP (During the first 7 days after IMP start)||2.84|0.14|0.5439
73831893|NCT05523297|147210614|OTHER||Mean ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.47|0.74|||Negative binomial regression|||Red blood cells (During the first 7 days after IMP start)||0.74|0.47|<0.0001
73831894|NCT05523297|147210614|OTHER||Mean ratio|0.58||||0.0042|TWO_SIDED|95.0|0.4|0.84|||Negative binomial regression|||Platelets (During the first 7 days after IMP start)||0.84|0.40|0.0042
73831895|NCT05523297|147210614|OTHER||Mean ratio|0.49||||0.2241|TWO_SIDED|95.0|0.15|1.56|||Negative binomial regression|||Cryoprecipitate (During the first 7 days after IMP start)||1.56|0.15|0.2241
73831896|NCT05523297|147210615|OTHER||Odds Ratio (OR)|0.9||||0.8364|TWO_SIDED|95.0|0.32|2.52|||Regression, Logistic|||FP excluding IMP (Within 24 hours after IMP start)||2.52|0.32|0.8364
73831897|NCT05523297|147210615|OTHER||Odds Ratio (OR)|2.11||||0.0002|TWO_SIDED|95.0|1.42|3.11|||Regression, Logistic|||RBCs (Within 24 hours after IMP start)||3.11|1.42|0.0002
73831898|NCT05523297|147210615|OTHER||Odds Ratio (OR)|1.31||||0.1742|TWO_SIDED|95.0|0.89|1.91|||Regression, Logistic|||Platelets (Within 24 hours after IMP start)||1.91|0.89|0.1742
73831899|NCT05523297|147210615|OTHER||Odds Ratio (OR)|1.4||||0.4618|TWO_SIDED|95.0|0.58|3.38|||Regression, Logistic|||Cryoprecipitate (Within 24 hours after IMP start)||3.38|0.58|0.4618
73831900|NCT05523297|147210615|OTHER||Odds Ratio (OR)|1.69||||0.0129|TWO_SIDED|95.0|1.12|2.55|||Regression, Logistic|||Any individual ABP (Within 24 hours after IMP start)||2.55|1.12|0.0129
73831901|NCT05523297|147210615|OTHER||Odds Ratio (OR)|1.58||||0.3297|TWO_SIDED|95.0|0.63|3.94|||Regression, Logistic|||FP excluding IMP (Within 7 days after IMP start)||3.94|0.63|0.3297
73831902|NCT05523297|147210615|OTHER||Odds Ratio (OR)|1.82||||0.0049|TWO_SIDED|95.0|1.2|2.76|||Regression, Logistic|||RBCs (Within 7 days after IMP start)||2.76|1.20|0.0049
73831903|NCT05523297|147210615|OTHER||Odds Ratio (OR)|1.26||||0.2417|TWO_SIDED|95.0|0.86|1.84|||Regression, Logistic|||Platelets (Within 7 days after IMP start)||1.84|0.86|0.2417
73831904|NCT05523297|147210615|OTHER||Odds Ratio (OR)|1.4||||0.4618|TWO_SIDED|95.0|0.58|3.38|||Regression, Logistic|||Cryoprecipitate (Within 7 days after IMP start)||3.38|0.58|0.4618
73831905|NCT05523297|147210615|OTHER||Odds Ratio (OR)|1.56||||0.0564|TWO_SIDED|95.0|0.99|2.47|||Regression, Logistic|||Any individual ABP (Within 7 days after IMP start)||2.47|0.99|0.0564
73831906|NCT05523297|147210616|OTHER||Odds Ratio (OR)|1.1||||0.6956|TWO_SIDED|95.0|0.69|1.73|||Regression, Logistic|||Fibrinogen concentrate (Within 24 hours after IMP start)||1.73|0.69|0.6956
73831907|NCT05523297|147210616|OTHER||Odds Ratio (OR)|5.337||||0.0317|TWO_SIDED|95.0|1.12|50.7|||Regression, Logistic|||||50.70|1.12|0.0317
73831908|NCT05523297|147210616|OTHER||Odds Ratio (OR)|18.88|||<|0.0001|TWO_SIDED|95.0|2.9|796.37|||Regression, Logistic|||PCC excluding IMP (Within 24 hours after IMP start)||796.37|2.90|<0.0001
73831909|NCT05523297|147210616|OTHER||Odds Ratio (OR)|1.334||||0.1981|TWO_SIDED|95.0|0.86|2.07|||Regression, Logistic|||Any coagulation factor product (Within 24 hours after IMP start)||2.07|0.86|0.1981
73831910|NCT05523297|147210616|OTHER||Odds Ratio (OR)|1.187||||0.4599|TWO_SIDED|95.0|0.75|1.87|||Regression, Logistic|||Fibrinogen concentrate (Within 7 days after IMP start)||1.87|0.75|0.4599
73831911|NCT05523297|147210616|OTHER||Odds Ratio (OR)|5.337||||0.0317|TWO_SIDED|95.0|1.12|50.7|||Regression, Logistic|||rFVIIa (Within 7 days after IMP start)||50.70|1.12|0.0317
73831912|NCT05523297|147210616|OTHER||Odds Ratio (OR)|18.88|||<|0.0001|TWO_SIDED|95.0|2.9|796.37|||Regression, Logistic|||PCC excluding IMP (Within 7 days after IMP start)||796.37|2.90|<0.0001
73831913|NCT05523297|147210616|OTHER||Odds Ratio (OR)|1.431||||0.1073|TWO_SIDED|95.0|0.93|2.21|||Regression, Logistic|||Any coagulation factor product (Within 7 days after IMP start)||2.21|0.93|0.1073
73831914|NCT05523297|147210619|OTHER||Odds Ratio (OR)|1.435||||0.3782|TWO_SIDED|95.0|0.6429|3.2013|||Regression, Logistic|||Within 24 hours after CPB end||3.2013|0.6429|0.3782
73831915|NCT05523297|147210619|OTHER||Odds Ratio (OR)|1.435||||0.3782|TWO_SIDED|95.0|0.6429|3.2013|||Regression, Logistic|||Within 24 hours after IMP start||3.2013|0.6429|0.3782
73831916|NCT05523297|147210619|OTHER||Odds Ratio (OR)|1.332||||0.4899|TWO_SIDED|95.0|0.5902|3.0062|||Regression, Logistic|||Within 24 hours after surgery start||3.0062|0.5902|0.4899
73831917|NCT05523297|147210620|OTHER||Least Squares Mean Difference|-0.15||||0.0081|TWO_SIDED|95.0|-0.26|-0.04|||ANOVA|||||-0.04|-0.26|0.0081
73831918|NCT05523297|147210621|OTHER||Least Squares Mean Difference|-9.63||||0.6735|TWO_SIDED|95.0|-60.45|41.18|||ANOVA|||||41.18|-60.45|0.6735
73831919|NCT05523297|147210622|OTHER||Least Squares Mean Difference|-17.93||||0.9033|TWO_SIDED|95.0|-450.13|414.28|||ANOVA|||||414.28|-450.13|0.9033
73831920|NCT05523297|147210623|OTHER||Least Squares Mean Difference|-0.41||||0.1808|TWO_SIDED|95.0|-1.1|0.29|||ANOVA|||||0.29|-1.10|0.1808
73831921|NCT05523297|147210624|OTHER||Least Squares Mean Difference|0.28||||0.9698|TWO_SIDED|95.0|-14.78|15.34|||ANOVA|||||15.34|-14.78|0.9698
73831922|NCT05523297|147210625|OTHER||Least Squares Mean Difference|-3.1||||0.3363|TWO_SIDED|95.0|-9.61|3.42|||ANOVA|||||3.42|-9.61|0.3363
73831923|NCT05523297|147210626|OTHER||Least Squares Mean Difference|2.42||||0.5736|TWO_SIDED|95.0|-6.33|11.16|||ANOVA|||||11.16|-6.33|0.5736
73831924|NCT05523297|147210627|OTHER||Least Squares Mean Difference|-13.19||||0.2667|TWO_SIDED|95.0|-37.05|10.67|||ANOVA|||||10.67|-37.05|0.2667
73831925|NCT05523297|147210628|OTHER||Least Squares Mean Difference|12.25||||0.0658|TWO_SIDED|95.0|-0.87|25.38|||ANOVA|||||25.38|-0.87|0.0658
73831926|NCT05523297|147210629|OTHER||Least Squares Mean Difference|-0.19||||0.0726|TWO_SIDED|95.0|-0.4|0.02|||ANOVA|||||0.02|-0.40|0.0726
73831927|NCT05523297|147210634|OTHER||Odds Ratio (OR)|1.183||||0.7497|TWO_SIDED|95.0|0.4211|3.3235|||Regression, Logistic|||||3.3235|0.4211|0.7497
73831928|NCT04133909|147210678|SUPERIORITY||Rate ratio (Mepolizumab 100 mg/Placebo)|0.79||||0.011|TWO_SIDED|95.0|0.66|0.94|||Negative binomial model|||Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate/severe exacerbations in previous year (less than or equal to \[\<=\]2, 3, \>=4 as ordinal), baseline percent (%) predicted Forced expiratory volume in one second (FEV1) and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable.||0.94|0.66|0.011
73831929|NCT04133909|147210679|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.009|TWO_SIDED|95.0|0.64|0.93|||Cox Proportional Hazards Model|||Estimated from a Cox Proportional Hazards Model with covariates of treatment group, geographic region, number of moderate or severe exacerbations in previous year \<=2, 3, \>=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs former).||0.93|0.64|0.009
73831930|NCT04133909|147210680|SUPERIORITY||Odds Ratio (OR)|0.81||||0.161|TWO_SIDED|95.0|0.6|1.09|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.09|0.60|0.161
73831931|NCT04133909|147210681|SUPERIORITY||Odds Ratio (OR)|1.17||||0.291|TWO_SIDED|95.0|0.87|1.57|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.57|0.87|0.291
73831932|NCT04133909|147210682|SUPERIORITY||Odds Ratio (OR)|0.82||||0.209|TWO_SIDED|95.0|0.6|1.12|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.12|0.60|0.209
73831933|NCT04133909|147210683|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.65||||0.032|TWO_SIDED|95.0|0.43|0.96|||Negative binomial model|||Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate/severe exacerbations in previous year (\<=2, 3, \>=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable. Estimates based on weighting applied to each level of class variable determined from observed proportions.||0.96|0.43|0.032
73831934|NCT05352763|147210731|OTHER|No statistical analysis performed|||||||||||||||||The classical summary of count and percentages will be provided for basic safety tabulations and dispositions as appropriate. All data will be presented in by-subject data listings. No inferential statistics will be produced.|||
73831935|NCT01787838|147210821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||<|0.0001|TWO_SIDED|95.0|1.65|1.96|||Chi-squared|||Prospective data from 12 months were compared to data that had been collected for the previous 12 month period to determine statistical significance and trended outcomes for comparative periods. Patients were screened for eligibility during the first 12 months, and staff and patients received the interventions during the second 12 month period.||1.96|1.65|<.0001
73831936|NCT01431976|147210822|SUPERIORITY_OR_OTHER||percentage of participants|35.0|||||TWO_SIDED|95.0|15.39|59.22||||||||59.22|15.39|
73831937|NCT00782067|147210839|OTHER|Single arm study|||||<|0.001|TWO_SIDED|95.0||||Null hypothesis: ORR \<= 30% Alternative hypothesis: ORR \>= 50%|Exact Binomial Test||||Exact Binomial 95% Confidence Interval|||<0.001
73831938|NCT00973973|147210854|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.107||0.0262|TWO_SIDED|95.0|-0.45|-0.03|||ANCOVA|Analysis of covariance (ANCOVA) model including baseline value as a covariate.||Comparison of Change from Baseline at Week 4||-0.03|-0.45|0.0262
73831939|NCT00973973|147210854|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.152|<|0.0001|TWO_SIDED|95.0|-1.06|-0.46|||ANCOVA|Analysis of covariance (ANCOVA) model, including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.46|-1.06|< 0.0001
73831940|NCT00973973|147210856|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.086||0.0163|TWO_SIDED|95.0|-0.38|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.04|-0.38|0.0163
73831941|NCT00973973|147210856|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.101||0.0066|TWO_SIDED|95.0|-0.48|-0.08|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.08|-0.48|0.0066
73831942|NCT00973973|147210858|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.082||0.0089|TWO_SIDED|95.0|-0.38|-0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.06|-0.38|0.0089
73831943|NCT00973973|147210858|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.0011|TWO_SIDED|95.0|-0.53|-0.14|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.14|-0.53|0.0011
73831944|NCT00973973|147210860|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.127||0.036|TWO_SIDED|95.0|-0.52|-0.02|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change form baseline at week 4||-0.02|-0.52|0.0360
73831945|NCT00973973|147210860|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.137||0.007|TWO_SIDED|95.0|-0.65|-0.11|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.11|-0.65|0.0070
73831946|NCT00973973|147210866|SUPERIORITY||LS Mean Difference|-9.84|STANDARD_ERROR_OF_MEAN|3.939||0.0137|TWO_SIDED|95.0|-17.63|-2.05|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-2.05|-17.63|0.0137
73831947|NCT00973973|147210866|SUPERIORITY||LS Mean Difference|-12.44|STANDARD_ERROR_OF_MEAN|3.913||0.0019|TWO_SIDED|95.0|-20.19|-4.7|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-4.70|-20.19|0.0019
73831948|NCT00973973|147210868|SUPERIORITY||LS Mean Difference|-6.21|STANDARD_ERROR_OF_MEAN|2.728||0.0244|TWO_SIDED|95.0|-11.61|-0.81|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.81|-11.61|0.0244
73831949|NCT00973973|147210868|SUPERIORITY||LS Mean Difference|-6.35|STANDARD_ERROR_OF_MEAN|2.549||0.0141|TWO_SIDED|95.0|-11.39|-1.3|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-1.30|-11.39|0.0141
73831950|NCT00973973|147210870|SUPERIORITY||LS Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|1.821||0.0893|TWO_SIDED|95.0|-6.72|0.49|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||0.49|-6.72|0.0893
73831951|NCT00973973|147210870|SUPERIORITY||LS Mean Difference|-3.52|STANDARD_ERROR_OF_MEAN|1.938||0.072|TWO_SIDED|95.0|-7.35|0.32|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||0.32|-7.35|0.0720
73831952|NCT00973973|147210872|SUPERIORITY||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|0.505|<|0.0001|TWO_SIDED|95.0|-3.26|-1.26|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of the change from baseline in CPSSS total score||-1.26|-3.26|< 0.0001
73831953|NCT00973973|147210872|SUPERIORITY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.41|-0.69|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dysmenorrhea score||-0.69|-1.41|< 0.0001
73831954|NCT00973973|147210872|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.143||0.0139|TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of non-menstrual pelvic pain score||-0.07|-0.64|0.0139
73831955|NCT00973973|147210872|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.173||0.1052|TWO_SIDED|95.0|-0.63|0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dyspareunia score||0.06|-0.63|0.1052
73831956|NCT00973973|147210872|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.143||0.0081|TWO_SIDED|95.0|-0.67|-0.1|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of pelvic tenderness score||-0.10|-0.67|0.0081
73831957|NCT00973973|147210872|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.125||0.024|TWO_SIDED|95.0|-0.53|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of induration score||-0.04|-0.53|0.0240
73831958|NCT00973973|147210874|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0012|TWO_SIDED|95.0|-1.2|-0.3|||ANOVA|||Comparison of Patient Global Impression of Change at week 4||-0.3|-1.2|0.0012
73831959|NCT00973973|147210874|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.26||0.0002|TWO_SIDED|95.0|-1.5|-0.5|||ANOVA|||Comparison of Patient Global Impression of Change at week 8||-0.5|-1.5|0.0002
73831960|NCT00973973|147210876|SUPERIORITY||Difference|19.4||||0.0136|TWO_SIDED|95.0|4.4|34.4|||Pearson chi-squared|||Comparison of response rates at week 4||34.4|4.4|0.0136
73831961|NCT00973973|147210876|SUPERIORITY||Difference|30.2||||0.0007|TWO_SIDED|95.0|13.6|46.7|||Pearson chi-squared|||Comparison of response rates at week 8||46.7|13.6|0.0007
73831962|NCT01401166|147210890|SUPERIORITY_OR_OTHER||Estimated Proportion|0.957|||||TWO_SIDED|95.0|0.903|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial confidence interval (CI) were determined.|||0.986|0.903|
73831963|NCT01401166|147210890|SUPERIORITY_OR_OTHER||Estimated Proportion|0.964|||||TWO_SIDED|95.0|0.908|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.986|0.908|
73831964|NCT01401166|147210890|SUPERIORITY_OR_OTHER||Estimated Proportion|0.874|||||TWO_SIDED|95.0|0.801|0.928|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.928|0.801|
73831965|NCT01401166|147210890|SUPERIORITY_OR_OTHER||Estimated Proportion|0.892|||||TWO_SIDED|95.0|0.804|0.943|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.943|0.804|
73831966|NCT01401166|147210890|SUPERIORITY_OR_OTHER||Estimated Proportion|0.839|||||TWO_SIDED|95.0|0.76|0.9|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.900|0.760|
73831967|NCT01401166|147210890|SUPERIORITY_OR_OTHER||Estimated Proportion|0.874|||||TWO_SIDED|95.0|0.776|0.933|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.933|0.776|
73831968|NCT01401166|147210890|SUPERIORITY_OR_OTHER||Estimated Proportion|0.885|||||TWO_SIDED|95.0|0.811|0.937|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.937|0.811|
73831969|NCT01401166|147210890|SUPERIORITY_OR_OTHER||Estimated Proportion|0.911|||||TWO_SIDED|95.0|0.827|0.956|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.956|0.827|
73831970|NCT02239328|147210900|OTHER|Multilevel random coefficient models estimated the mean score of each PROMIS domain as a function of time elapsed between date of surgery and assessment (in years), and patient comorbidity. Statistical significance of estimated fixed effects were assessed by the F-test statistic for type 3 tests, p \< 0.05.|||||<|0.05|||||||ANOVA|||||||<0.05
73831971|NCT03483103|147210901|SUPERIORITY||||||<|0.0001||||||One sided P-value is calculated based on the null hypothesis ORR \<= 50.2%|Exact binomial test|||||||<.0001
73831972|NCT00689936|147211012|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||6e-05|TWO_SIDED|95.0|0.61|0.85||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||0.85|0.61|0.00006
73831973|NCT00689936|147211012|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||1e-05|TWO_SIDED|95.0|0.6|0.82||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||0.82|0.60|0.00001
73831974|NCT00689936|147211012|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.70349|TWO_SIDED|95.0|0.89|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.20|0.89|0.70349
73831975|NCT00689936|147211013|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|1e-05|TWO_SIDED|95.0|0.59|0.79||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.79|0.59|<0.00001
73831976|NCT00689936|147211013|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|1e-05|TWO_SIDED|95.0|0.6|0.81||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.81|0.60|<0.00001
73831977|NCT00689936|147211013|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.91161|TWO_SIDED|95.0|0.86|1.14||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.14|0.86|0.91161
73831978|NCT00689936|147211014|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.00234|TWO_SIDED|95.0|0.67|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.92|0.67|0.00234
73831979|NCT00689936|147211014|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.82903|TWO_SIDED|95.0|0.86|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.20|0.86|0.82903
73831980|NCT00689936|147211014|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.00119|TWO_SIDED|95.0|0.66|0.9||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.90|0.66|0.00119
73831981|NCT00689936|147211015|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83|||<|1e-05|TWO_SIDED|95.0|1.41|2.37|||Fisher Exact|||||2.37|1.41|<0.00001
73831982|NCT00689936|147211015|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.1||||0.53065|TWO_SIDED|95.0|0.83|1.44|||Fisher Exact|||||1.44|0.83|0.53065
73831983|NCT00689936|147211015|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.0001|TWO_SIDED|95.0|1.29|2.15|||Fisher Exact|||||2.15|1.29|0.00010
73831984|NCT00689936|147211016|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02|||<|1e-05|TWO_SIDED|95.0|1.53|2.68|||Fisher Exact|||||2.68|1.53|<0.00001
73831985|NCT00689936|147211016|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.405|TWO_SIDED|95.0|0.85|1.54|||Fisher Exact|||||1.54|0.85|0.40500
73831986|NCT00689936|147211016|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||4e-05|TWO_SIDED|95.0|1.35|2.32|||Fisher Exact|||||2.32|1.35|0.00004
73831987|NCT00689936|147211017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|1e-05|TWO_SIDED|95.0|0.51|0.76||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.76|0.51|<0.00001
73831988|NCT00689936|147211017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|1e-05|TWO_SIDED|95.0|0.5|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.72|0.50|<0.00001
73831989|NCT00689936|147211017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.7674|TWO_SIDED|95.0|0.86|1.23||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||1.23|0.86|0.76740
73831990|NCT00689936|147211018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.51|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.72|0.51|<0.00001
73831991|NCT00689936|147211018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.52|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.72|0.52|<0.00001
73831992|NCT00689936|147211018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.99537|TWO_SIDED|95.0|0.85|1.17||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.17|0.85|0.99537
73831993|NCT00689936|147211019|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
73831994|NCT00689936|147211019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46672|||||||Wilcoxon (Mann-Whitney)|||||||0.46672
73831995|NCT00689936|147211019|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
73831996|NCT00689936|147211020|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
73831997|NCT00689936|147211020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46987|||||||Wilcoxon (Mann-Whitney)|||||||0.46987
73831998|NCT00689936|147211020|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
73831999|NCT00689936|147211021|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.00012|TWO_SIDED|95.0|0.68|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.88|0.68|0.00012
73832000|NCT00689936|147211021|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.00187|TWO_SIDED|95.0|0.71|0.93||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.93|0.71|0.00187
73832001|NCT00689936|147211021|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.45973|TWO_SIDED|95.0|0.84|1.08||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.08|0.84|0.45973
73832002|NCT00689936|147211022|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||2e-05|TWO_SIDED|95.0|0.67|0.86||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.86|0.67|0.00002
73832003|NCT00689936|147211022|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.00126|TWO_SIDED|95.0|0.72|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.92|0.72|0.00126
73832004|NCT00689936|147211022|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.27704|TWO_SIDED|95.0|0.83|1.06||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.06|0.83|0.27704
73832005|NCT00689936|147211023|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||<|1e-05|TWO_SIDED|95.0|0.56|0.78||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.78|0.56|<0.00001
73832006|NCT00689936|147211023|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.00067|TWO_SIDED|95.0|0.63|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.88|0.63|0.00067
73832007|NCT00689936|147211023|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.12333|TWO_SIDED|95.0|0.75|1.03||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.03|0.75|0.12333
73832008|NCT00689936|147211024|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|1e-05|TWO_SIDED|95.0|0.54|0.73||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||.73|0.54|<0.00001
73832009|NCT00689936|147211024|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||1e-05|TWO_SIDED|95.0|0.61|0.83||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.83|0.61|0.00001
73832010|NCT00689936|147211024|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.05821|TWO_SIDED|95.0|0.76|1.0||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||1.00|0.76|0.05821
73832011|NCT00689936|147211025|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.93824|TWO_SIDED|95.0|0.75|1.38|||Fisher Exact|||||1.38|0.75|0.93824
73832012|NCT00689936|147211025|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.08836|TWO_SIDED|95.0|0.56|1.03|||Fisher Exact|||||1.03|0.56|0.08836
73832013|NCT00689936|147211025|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34||||0.04974|TWO_SIDED|95.0|1.01|1.79|||Fisher Exact|||||1.79|1.01|0.04974
73832014|NCT00689936|147211026|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.02134|TWO_SIDED|95.0|1.08|2.59|||Fisher Exact|||||2.59|1.08|0.02134
73832015|NCT00689936|147211026|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.64|1.59|||Fisher Exact|||||1.59|0.64|1.00000
73832016|NCT00689936|147211026|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.65||||0.02374|TWO_SIDED|95.0|1.08|2.53|||Fisher Exact|||||2.53|1.08|0.02374
73832017|NCT00689936|147211027|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7||||0.11152|TWO_SIDED|95.0|0.91|3.21|||Fisher Exact|||||3.21|0.91|0.11152
73832018|NCT00689936|147211027|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93||||0.86336|TWO_SIDED|95.0|0.47|1.83|||Fisher Exact|||||1.83|0.47|0.86336
73832019|NCT00689936|147211027|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.07321|TWO_SIDED|95.0|0.96|3.55|||Fisher Exact|||||3.55|0.96|0.07321
73832020|NCT00689936|147211028|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.62||||0.00043|TWO_SIDED|95.0|1.55|4.45|||Fisher Exact|||||4.45|1.55|0.00043
73832021|NCT00689936|147211028|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.31274|TWO_SIDED|95.0|0.78|2.43|||Fisher Exact|||||2.43|0.78|0.31274
73832022|NCT00689936|147211028|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.01936|TWO_SIDED|95.0|1.13|3.19|||Fisher Exact|||||3.19|1.13|0.01936
73832023|NCT00689936|147211029|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.82128|TWO_SIDED|95.0|0.46|2.8|||Fisher Exact|||||2.80|0.46|0.82128
73832024|NCT00689936|147211029|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.11041|TWO_SIDED|95.0|0.19|1.14|||Fisher Exact|||||1.14|0.19|0.11041
73832025|NCT00689936|147211029|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.44||||0.07302|TWO_SIDED|95.0|1.01|5.91|||Fisher Exact|||||5.91|1.01|0.07302
73832026|NCT00311168|147211071|SUPERIORITY|A target of an 80% reduction in percentage of ventricular pacing with VIP™ is proposed in this study. In order to achieve an 80% power of detecting an 80% reduction in the percentage of ventricular paced events and using a two group two-sided t-test of equal means, a minimum sample size of 39 patients per group was required. To account for possible withdrawal or loss to follow-up, this study targeted to enroll 100 patients (50 per group).|Mean Difference (Final Values)|-60.2|STANDARD_DEVIATION|19.0|<|0.0001|TWO_SIDED|95.0|-67.5|-52.9|||t-test, 2 sided||Mean difference in the percentage of intrinsic ventricular events is presented as, VIP Off - VIP On.|||-52.9|-67.5|<0.0001
73832027|NCT06001866|147211111|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
73832028|NCT06001866|147211111|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73832029|NCT06001866|147211112|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73832030|NCT06001866|147211112|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73832031|NCT06001866|147211113|SUPERIORITY||||||=|0.78|||||||LSD test|||||||=0.78
73832032|NCT06001866|147211113|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<.00001
73832033|NCT06001866|147211114|SUPERIORITY||||||=|1|||||||LSD test|||||||=1.00
73832034|NCT06001866|147211114|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73832035|NCT06001866|147211115|SUPERIORITY||||||=|0.75|||||||LSD test|||||||=0.75
73832036|NCT06001866|147211115|SUPERIORITY||||||<|0.01|||||||LSD test|||||||<0.01
73832037|NCT06001866|147211116|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
73832038|NCT06001866|147211116|SUPERIORITY||||||=|0.62|||||||LSD test|||||||=0.62
73832039|NCT06001866|147211117|SUPERIORITY||||||=|0.16|||||||LSD test|||||||=0.16
73832040|NCT06001866|147211117|SUPERIORITY||||||=|0.33|||||||LSD test|||||||=0.33
73832041|NCT06001866|147211118|SUPERIORITY||||||=|0.54|||||||t-test, 2 sided|||||||=.54
73832042|NCT06001866|147211119|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
73832043|NCT02903914|147211127|OTHER|||||||0.0731|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.0731
73832044|NCT02903914|147211127|OTHER||pairwise geometric mean ratio (GMR)|0.933|||||TWO_SIDED|90.0|0.784|1.11||||||||1.110|0.784|
73832045|NCT02903914|147211127|OTHER||pairwise GMR|1.074|||||TWO_SIDED|90.0|0.908|1.271||||||||1.271|0.908|
73832046|NCT02903914|147211127|OTHER||pairwise GMR|1.23|||||TWO_SIDED|90.0|1.034|1.463||||||||1.463|1.034|
73832047|NCT02903914|147211128|OTHER|||||||0.1496|||||||Kruskal-Wallis|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1496
73832048|NCT02903914|147211129|OTHER|||||||0.2867|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2867
73832049|NCT02903914|147211129|OTHER||pairwise GMR|1.007|||||TWO_SIDED|90.0|0.825|1.23||||||||1.230|0.825|
73832050|NCT02903914|147211129|OTHER||pairwise GMR|1.081|||||TWO_SIDED|90.0|0.892|1.311||||||||1.311|0.892|
73832051|NCT02903914|147211129|OTHER||pairwise GMR|1.234|||||TWO_SIDED|90.0|1.011|1.507||||||||1.507|1.011|
73832052|NCT02903914|147211130|OTHER|||||||0.6167|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.6167
73832053|NCT02903914|147211130|OTHER||pairwise GMR|1.014|||||TWO_SIDED|90.0|0.82|1.255||||||||1.255|0.820|
73832054|NCT02903914|147211130|OTHER||pairwise GMR|1.043|||||TWO_SIDED|90.0|0.849|1.281||||||||1.281|0.849|
73832055|NCT02903914|147211130|OTHER||pairwise GMR|1.17|||||TWO_SIDED|90.0|0.945|1.447||||||||1.447|0.945|
73832056|NCT02903914|147211134|OTHER|||||||0.0745|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.0745
73832057|NCT02903914|147211134|OTHER||pairwise GMR|1.127|||||TWO_SIDED|90.0|0.947|1.341||||||||1.341|0.947|
73832058|NCT02903914|147211134|OTHER||pairwise GMR|0.991|||||TWO_SIDED|90.0|0.833|1.18||||||||1.180|0.833|
73832059|NCT02903914|147211134|OTHER||pairwise GMR|1.258|||||TWO_SIDED|90.0|1.064|1.486||||||||1.486|1.064|
73832060|NCT02903914|147211135|OTHER|||||||0.0518|||||||Kruskal-Wallis|||||||0.0518
73832061|NCT02903914|147211136|OTHER|||||||0.1723|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1723
73832062|NCT02903914|147211136|OTHER||pairwise GMR|1.156|||||TWO_SIDED|90.0|0.941|1.42||||||||1.420|0.941|
73832063|NCT02903914|147211136|OTHER||pairwise GMR|0.976|||||TWO_SIDED|90.0|0.794|1.198||||||||1.198|0.794|
73832064|NCT02903914|147211136|OTHER||pairwise GMR|1.233|||||TWO_SIDED|90.0|1.012|1.503||||||||1.503|1.012|
73832065|NCT02903914|147211137|OTHER|||||||0.1705|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1705
73832066|NCT02903914|147211137|OTHER||pairwise GMR|1.083|||||TWO_SIDED|90.0|0.863|1.359||||||||1.359|0.863|
73832067|NCT02903914|147211137|OTHER||pairwise GMR|0.902|||||TWO_SIDED|90.0|0.719|1.132||||||||1.132|0.719|
73832068|NCT02903914|147211137|OTHER||pairwise GMR|1.212|||||TWO_SIDED|90.0|0.945|1.554||||||||1.554|0.945|
73832069|NCT02903914|147211141|OTHER||pairwise GMR|1.057||||0.7702|TWO_SIDED|90.0|0.753|1.483|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.483|0.753|0.7702
73832070|NCT02903914|147211141|OTHER||pairwise GMR|1.012||||0.9384|TWO_SIDED|90.0|0.762|1.346|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.346|0.762|0.9384
73832071|NCT02903914|147211141|OTHER||pairwise GMR|1.07||||0.6733|TWO_SIDED|90.0|0.809|1.415|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.415|0.809|0.6733
73832072|NCT02903914|147211141|OTHER||pairwise GMR|1.238||||0.3456|TWO_SIDED|90.0|0.83|1.847|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.847|0.830|0.3456
73832073|NCT02903914|147211142|OTHER|||||||0.0441|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.0441
73832074|NCT02903914|147211142|OTHER|||||||0.4092|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.4092
73832075|NCT02903914|147211142|OTHER|||||||0.7748|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.7748
73832076|NCT02903914|147211142|OTHER|||||||0.1948|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.1948
73832077|NCT02903914|147211143|OTHER||pairwise GMR|0.92||||0.705|TWO_SIDED|90.0|0.62|1.363|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.363|0.620|0.7050
73832078|NCT02903914|147211143|OTHER||pairwise GMR|0.929||||0.703|TWO_SIDED|90.0|0.658|1.31|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.310|0.658|0.7030
73832079|NCT02903914|147211143|OTHER||pairwise GMR|0.999||||0.9952|TWO_SIDED|90.0|0.725|1.377|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.377|0.725|0.9952
73832080|NCT02903914|147211143|OTHER||pairwise GMR|0.742||||0.4012|TWO_SIDED|90.0|0.394|1.397|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.397|0.394|0.4012
73832081|NCT02903914|147211144|OTHER||pairwise GMR|0.992||||0.9623|TWO_SIDED|90.0|0.729|1.349|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)||Tablet (test) versus Capsule (reference)||1.349|0.729|0.9623
73832082|NCT02903914|147211145|OTHER|||||||0.754|||||||Wilcoxon (Mann-Whitney)|||Tablet (test) versus Capsule (reference)||||0.7540
73832083|NCT02903914|147211146|OTHER||pairwise GMR|0.951||||0.7514|TWO_SIDED|90.0|0.718|1.261|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||Tablet (test) versus Capsule (reference)||1.261|0.718|0.7514
73832084|NCT02903914|147211147|OTHER||pairwise GMR|0.954||||0.7707|TWO_SIDED|90.0|0.712|1.277|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)||Tablet (test) versus Capsule (reference)||1.277|0.712|0.7707
73832085|NCT03112603|147211179|OTHER||Odds Ratio (OR)|2.99|||<|0.0001|TWO_SIDED|95.0|1.86|4.8|||Cochran-Mantel-Haenszel|||||4.80|1.86|<0.0001
73832086|NCT03112603|147211181|OTHER||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.268|0.51||The p-value was derived from a 1-sided stratified log-rank test.|Log Rank||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||0.510|0.268|<0.0001
73832087|NCT03112603|147211182|OTHER||Hazard Ratio (HR)|0.361|||||TWO_SIDED|95.0|0.268|0.485|||||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||0.485|0.268|
73832088|NCT03112603|147211183|OTHER||Odds Ratio (OR)|2.17||||0.0011|TWO_SIDED|95.0|1.34|3.52||The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel||The odds ratio and 95% confidence interval (CI) were calculated using a stratified Cochran-Mantel-Haenszel test.|||3.52|1.34|0.0011
73832089|NCT03112603|147211185|OTHER||Odds Ratio (OR)|2.77|||<|0.0001|TWO_SIDED|95.0|1.75|4.39||The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel (CMH) test.|Cochran-Mantel-Haenszel||The odds ratio and 95% CI were calculated using a stratified CMH test.|||4.39|1.75|<0.0001
73832090|NCT03112603|147211187|OTHER||Hazard Ratio (HR)|0.851||||0.2396|TWO_SIDED|95.0|0.544|1.331||The p-value was derived from a 1-sided stratified log-rank test.|Log Rank||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||1.331|0.544|0.2396
73832091|NCT04725188|147211203|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.091|TWO_SIDED|95.0|0.53|1.13|||Regression, Cox|||||1.13|0.53|0.0910
73832092|NCT04725188|147211203|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.9622|TWO_SIDED|95.0|0.96|2.02|||Regression, Cox|||||2.02|0.96|0.9622
73832093|NCT04725188|147211204|SUPERIORITY||Difference in percentage|14.7||||0.0113|TWO_SIDED|95.0|2.1|26.9|||Miettinen & Nurminen method|||||26.9|2.1|0.0113
73832094|NCT04725188|147211204|SUPERIORITY||Difference in percentage|-9.4||||0.975|TWO_SIDED|95.0|-19.6|0.0|||Miettinen & Nurminen method|||||0.0|-19.6|0.9750
73832095|NCT04725188|147211205|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0943|TWO_SIDED|95.0|0.5|1.15|||Regression, Cox|||||1.15|0.50|0.0943
73832096|NCT04725188|147211205|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.5974|TWO_SIDED|95.0|0.7|1.58|||Regression, Cox|||||1.58|0.70|0.5974
73832097|NCT05850494|147211217|NON_INFERIORITY|Non-inferiority margin of -0.200 L at a one-sided significance level of 0.025.|Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.0136|||TWO_SIDED|95.0|-0.037|0.018||P-Value not applicable since a non-inferiority test was used for the analysis.|Mixed Models Analysis|||||0.018|-0.037|
73832098|NCT00695019|147211267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Chi-squared|||||||0.61
73832099|NCT00695019|147211268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0|||||Chi-squared|||||||0.48
73832100|NCT00695019|147211269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||95.0|||||Kruskal-Wallis|||||||0.77
73832101|NCT00695019|147211270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Kruskal-Wallis|||||||0.30
73832102|NCT00695019|147211271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72||95.0|||||Chi-squared|||||||0.72
73832103|NCT00695019|147211272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0023||95.0||||Analysis not adjusted to account for baseline differences between the groups.|Kruskal-Wallis|||||||0.0023
73832104|NCT00695019|147211273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||95.0|||||Kruskal-Wallis|||Fibrotest provides an estimate of liver fibrosis based on the values of 5 serum markers. Scores range from 0 to 1 with higher scores indicating a greater level of liver fibrosis. A negative change in Fibrotest score is therefore deemed to indicate improvement (reduction in fibrosis), while a positive change indicates worsening condition.||||0.21
73832105|NCT00695019|147211274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Chi-squared|||||||0.03
73832106|NCT00695019|147211274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Chi-squared|||||||0.005
73832107|NCT03116230|147211275|OTHER|||||||0.005|||||||t-test, 2 sided|Treatment A vs Control||||||0.005
73832108|NCT03116230|147211275|OTHER|||||||0.64|||||||t-test, 2 sided|Treatment B vs Control||||||0.64
73832109|NCT05495997|147211297|SUPERIORITY|||||||0.015|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)||||0.015
73832110|NCT05495997|147211298|SUPERIORITY|||||||0.993|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)||||0.993
73832111|NCT05495997|147211299|SUPERIORITY|||||||0.517|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)||||0.517
73832112|NCT05495997|147211300|SUPERIORITY|||||||0.817|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)||||0.817
73832113|NCT02296125|147211312|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.37|0.57|||Log Rank|||||0.57|0.37|<0.0001
73832114|NCT02296125|147211312|OTHER|The china cohort was not powered for superiority|Hazard Ratio (HR)|0.56||||0.0065|TWO_SIDED|95.0|0.37|0.85|||Log Rank|||||0.85|0.37|0.0065
73832115|NCT02296125|147211314|SUPERIORITY||Odds Ratio (OR)|1.51||||0.036|TWO_SIDED|95.0|1.03|2.22|||Regression, Logistic|||||2.22|1.03|0.036
73832116|NCT02296125|147211314|OTHER|The china cohort was not powered for superiority|Odds Ratio (OR)|1.31||||0.485|TWO_SIDED|95.0|0.61|2.84|||Regression, Logistic|||||2.84|0.61|0.485
73832117|NCT02296125|147211315|OTHER|The china cohort was not powered for superiority|Mean Difference (Final Values)|2.48||||0.0133|TWO_SIDED|95.0|1.21|5.09|||Regression, Linear|||||5.09|1.21|0.0133
73832118|NCT02296125|147211315|SUPERIORITY||Mean Difference (Final Values)|2.27|||<|0.0001|TWO_SIDED|95.0|1.68|3.08|||Regression, Linear|||||3.08|1.68|<0.0001
73832119|NCT02296125|147211316|SUPERIORITY||Odds Ratio (OR)|2.78||||0.011|TWO_SIDED|95.0|1.25|6.78|||Regression, Logistic||An odds ratio \> 1 favours osimertinib|||6.78|1.25|0.0110
73832120|NCT02296125|147211316|OTHER|The china cohort was not powered for superiority|Odds Ratio (OR)|1.67||||0.5772|TWO_SIDED|95.0|0.27|12.98|||Regression, Logistic||An odds ratio \>1 favours osimertinib|||12.98|0.27|0.5772
73832121|NCT02296125|147211317|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0025|TWO_SIDED|95.0|-11.205|-2.403|||Regression, Linear|||||-2.403|-11.205|0.0025
73832122|NCT02296125|147211317|OTHER|The china cohort was not powered for superiority|Mean Difference (Final Values)|-6.59||||0.1348|TWO_SIDED|95.0|-15.246|2.072|||Regression, Linear|||||2.072|-15.246|0.1348
73832123|NCT02296125|147211318|SUPERIORITY||Hazard Ratio (HR)|0.799||||0.0462|TWO_SIDED|95.0|0.6409|0.9963|||Log Rank|||||0.9963|0.6409|0.0462
73832124|NCT02296125|147211318|OTHER|The china cohort was not powered for superiority|Hazard Ratio (HR)|0.848||||0.4416|TWO_SIDED|95.0|0.5568|1.291|||Log Rank|||||1.2910|0.5568|0.4416
73832125|NCT05845619|147211351|SUPERIORITY|There was no power calculation because this was a pilot study.|Odds Ratio (OR)|1.21||||0.33|TWO_SIDED|95.0|0.83|1.76|||Regression, Logistic||Numerator: pilot; denominator: prospective controls|In this pilot study, we hypothesized that pilot participants would have a reduced risk of viremia 6 months after the intervention compared to controls.||1.76|0.83|0.33
73832126|NCT05845619|147211351|SUPERIORITY|No power calculation, pilot study.|Odds Ratio (OR)|1.25||||0.41|TWO_SIDED|95.0|0.73|2.14|||Regression, Logistic|||||2.14|0.73|0.41
73832127|NCT05168800|147211383|SUPERIORITY|||||||0.99||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or greater than 2.15 standard deviations of the mean for the superiority analyses.|Groupwise binomial comparison|||||||0.99
73832128|NCT05168800|147211383|SUPERIORITY|||||||0.98||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or greater than 2.15 standard deviations of the mean for the superiority analyses.|Groupwise binomial comparison|||||||0.98
73832129|NCT05168800|147211383|EQUIVALENCE|A sample size of 1800 LTCWs (600 per arm) was identified to provide 80% power to detect an 8% difference in the rate of individuals reporting vaccine confidence between arms with 95% confidence. This sample size was sufficient to retain 80% power to detect a 10% difference after 40% attrition. Per study design, the equivalence margin is +/- 10% with anticipated attrition using the binomial confidence interval.||||||0.85||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or +/- 2.45 standard deviations of the mean for the equivalency test.|Groupwise binomial comparison|||||||0.85
73832130|NCT05168800|147211384|SUPERIORITY|||||||0.93|||||||Fisher Exact|||||||0.93
73832131|NCT05168800|147211384|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.90
73832132|NCT05168800|147211384|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.83|||||||Fisher Exact|||||||0.83
73832133|NCT05168800|147211385|SUPERIORITY|||||||0.22|||||||Fisher Exact|||||||0.22
73832134|NCT05168800|147211385|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
73832135|NCT05168800|147211385|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.61|||||||Fisher Exact|||||||0.61
73832136|NCT05168800|147211386|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||0.65
73832137|NCT05168800|147211386|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
73832138|NCT05168800|147211386|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.48|||||||Fisher Exact|||||||0.48
73832139|NCT05168800|147211387|SUPERIORITY|||||||0.88|||||||Adjusted Wald test|||||||0.88
73832140|NCT05168800|147211387|SUPERIORITY|||||||0.97|||||||Adjusted Wald test|||||||0.97
73832141|NCT05168800|147211387|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.48|||||||Adjusted Wald test|||||||0.48
73832142|NCT05168800|147211388|SUPERIORITY|||||||0.95|||||||Adjusted Wald test|||||||0.95
73832143|NCT05168800|147211388|SUPERIORITY|||||||0.98|||||||Adjusted Wald test|||||||0.98
73832144|NCT05168800|147211388|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.66|||||||Adjusted Wald test|||||||0.66
73832145|NCT05168800|147211389|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
73832146|NCT05168800|147211389|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.64
73832147|NCT05168800|147211389|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.09|||||||Fisher Exact|||||||0.09
73832148|NCT05168800|147211390|SUPERIORITY|||||||0.13|||||||Fisher Exact|||||||0.13
73832149|NCT05168800|147211390|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
73832150|NCT05168800|147211390|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.1|||||||Fisher Exact|||||||0.10
73832151|NCT05168800|147211391|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
73832152|NCT05168800|147211391|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
73832153|NCT05168800|147211391|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.88|||||||Fisher Exact|||||||0.88
73832154|NCT05168800|147211392|SUPERIORITY|||||||0.92|||||||Adjusted Wald test|||||||0.92
73832155|NCT05168800|147211392|SUPERIORITY|||||||0.97|||||||Adjusted Wald test|||||||0.97
73832156|NCT05168800|147211392|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.83|||||||Adjusted Wald test|||||||0.83
73832157|NCT05168800|147211393|SUPERIORITY|||||||0.88|||||||Adjusted Wald test|||||||0.88
73832158|NCT05168800|147211393|SUPERIORITY|||||||0.49|||||||Adjusted Wald test|||||||0.49
73832159|NCT05168800|147211393|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.23|||||||Adjusted Wald test|||||||0.23
73832160|NCT05168800|147211394|SUPERIORITY|||||||0.9|||||||Adjusted Wald test|||||||0.90
73832161|NCT05168800|147211394|SUPERIORITY|||||||0.94|||||||Adjusted Wald test|||||||0.94
73832162|NCT05168800|147211394|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.86|||||||Adjusted Wald test|||||||0.86
73832163|NCT05168800|147211395|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.00
73832164|NCT05168800|147211395|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.0
73832165|NCT05168800|147211395|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.49|||||||Two-sample z test|||||||0.49
73832166|NCT05168800|147211396|SUPERIORITY|||||||0.88|||||||Two-sample z test|||||||0.88
73832167|NCT05168800|147211396|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.00
73832168|NCT05168800|147211396|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.02|||||||Two-sample z test|||||||0.02
73832169|NCT05168800|147211397|SUPERIORITY|||||||0.82|||||||Two-sample z test|||||||0.82
73832170|NCT05168800|147211397|SUPERIORITY|||||||0.97|||||||Two-sample z test|||||||0.97
73832171|NCT05168800|147211397|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.18|||||||Two-sample z test|||||||0.18
73832172|NCT04556097|147211405|SUPERIORITY||Rate Ratio|0.61|STANDARD_ERROR_OF_MEAN|0.35||0.05|TWO_SIDED|95.0|0.31|1.2|||Difference in differences|Difference in differences model with a negative binomial distribution and log link that provides rate ratio estimate of the relative difference.|The rate ratio is estimated for intervention patients as compared to controls.|||1.20|0.31|0.05
73832173|NCT04556097|147211406|SUPERIORITY||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.95||0.05|TWO_SIDED|95.0|-6.53|1.12|||Difference in differences|Difference in differences model with a Gaussian distribution and identity link that provides linear estimate of the relative point difference.||||1.12|-6.53|0.05
73832174|NCT01970371|147211440|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|26.5|||||TWO_SIDED|90.0|-0.7|51.2|||1-sided Fisher's exact test|||||51.2|-0.7|
73832175|NCT01970371|147211441|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|28.2|||||TWO_SIDED|90.0|0.7|52.5|||1-sided Fisher's exact test|||||52.5|0.7|
73832176|NCT01970371|147211442|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference in clinical cure percentage at the TOC visit between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|-0.3|||||TWO_SIDED|90.0|-26.9|26.8|||1-sided Fisher's exact test|||||26.8|-26.9|
73832177|NCT01970371|147211443|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the unadjusted hazard ratio between groups in Cohort 1 (colistin:plazomicin) is based on a Cox proportional hazards regression model.|Hazard Ratio (HR)|3.97|||||TWO_SIDED|90.0|1.08|14.61|||1-sided logrank test|||||14.61|1.08|
73832178|NCT01970371|147211444|SUPERIORITY|The two-sided 90% confidence interval for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|14.1|||||TWO_SIDED|90.0|-13.0|40.3|||1-sided Fisher's exact test|||||40.3|-13|
73832179|NCT01348269|147211450|OTHER|T-test (with MITT, omitting outlier value of one patient in placebo group)|||||=|0.006|||||||t-test, 2 sided|||||||=0.006
73832180|NCT01348269|147211450|OTHER|Mann-Whitney-Test|||||=|0.015|||||||Wilcoxon (Mann-Whitney)|||||||=0.015
73832181|NCT02313155|147211485|SUPERIORITY_OR_OTHER||Difference|-6.6|||||TWO_SIDED|95.0|-24.858|11.592|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H1N1 Strain||11.592|-24.858|
73832182|NCT02313155|147211485|SUPERIORITY_OR_OTHER||Difference|-15.5|||||TWO_SIDED|95.0|-33.779|2.87|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H3N2 Strain||2.870|-33.779|
73832183|NCT02313155|147211485|SUPERIORITY_OR_OTHER||Difference|-11.8|||||TWO_SIDED|95.0|-30.048|6.547|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|B Strain||6.547|-30.048|
73832184|NCT02452190|147211539|SUPERIORITY|A fixed-sequence multiple testing procedure was implemented to test the primary and secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.|CAE rate ratio (reslizumab vs placebo)|0.79||||0.194|TWO_SIDED|95.0|0.562|1.124||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group, randomization stratification factors, and number of prior exacerbations as model factors and the logarithm of treatment duration excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.124|0.562|0.194
73832185|NCT01081951|147211599|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0012|TWO_SIDED|95.0|0.34|0.77||The use of a one-sided 10% significance level test will be used to assess the statistical significance of the analyses of PFS.|Log Rank|Stratified by number of prior platinum treatment lines (1 or \>1) and time to progression following previous platinum therapy (\>6 to ≤12 vs \>12 months)|A hazard ratio of \< 1 favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.||0.77|0.34|0.0012
73832186|NCT01081951|147211600|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.4379|TWO_SIDED|95.0|0.79|1.73||Two sided|Log Rank|Stratified by number of prior platinum treatment lines (1 or \>1) and time to progression following previous platinum therapy (\>6 to ≤12 vs \>12 months)|A hazard ratio \< 1 favours favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.||1.73|0.79|0.4379
73832187|NCT03806296|147211717|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.018|TWO_SIDED|95.0|-0.77|-0.07|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||-0.07|-0.77|0.018
73832188|NCT03806296|147211717|SUPERIORITY||Time X Group interaction|0.67||||0.001|TWO_SIDED|95.0|0.28|1.07|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||1.07|0.28|0.001
73832189|NCT03806296|147211718|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.61|1.59|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||1.59|0.61|<0.001
73832190|NCT03806296|147211718|SUPERIORITY||Time X Group interaction|-0.76|||<|0.001|TWO_SIDED|95.0|-1.09|-0.43|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||-0.43|-1.09|<0.001
73832191|NCT03806296|147211719|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.365|TWO_SIDED|95.0|-0.64|0.24|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.24|-0.64|0.365
73832192|NCT03806296|147211719|SUPERIORITY||Time X Group interaction|-0.43||||0.067|TWO_SIDED|95.0|-0.88|0.03|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||0.03|-0.88|0.067
73832193|NCT03806296|147211720|SUPERIORITY||Mean Difference (Final Values)|3.32||||0.234|TWO_SIDED|95.0|-2.18|8.82|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||8.82|-2.18|0.234
73832194|NCT03806296|147211720|SUPERIORITY||Time X Group interaction|-6.15||||0.018|TWO_SIDED|95.0|-11.25|-1.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||-1.06|-11.25|0.018
73832195|NCT03806296|147211721|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.024|TWO_SIDED|95.0|0.07|0.94|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.94|0.07|0.024
73832196|NCT03806296|147211721|SUPERIORITY||Time X Group interaction|-0.1||||0.66|TWO_SIDED|95.0|-0.55|0.35|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.35|-0.55|0.660
73832197|NCT03806296|147211722|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.592|TWO_SIDED|95.0|-0.03|0.06|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.06|-0.03|0.592
73832198|NCT03806296|147211722|SUPERIORITY||Time X Group interaction|-0.03||||0.55|TWO_SIDED|95.0|-0.11|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.11|0.550
73832199|NCT03806296|147211723|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.55|TWO_SIDED|95.0|-0.07|0.04|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.04|-0.07|0.550
73832200|NCT03806296|147211723|SUPERIORITY||Time X Group interaction|-0.02||||0.556|TWO_SIDED|95.0|-0.1|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.10|0.556
73832201|NCT03806296|147211724|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.124|TWO_SIDED|95.0|-0.01|0.06|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.06|-0.01|0.124
73832202|NCT03806296|147211724|SUPERIORITY||Time X Group interaction|0.0||||0.925|TWO_SIDED|95.0|-0.05|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.05|0.925
73832203|NCT03806296|147211725|SUPERIORITY||Risk Ratio (RR)|0.752||||0.42|TWO_SIDED|95.0|0.374|1.513|||Poisson GLM with robust standard error||Early/Middle Sleep group was the reference group (lower RR indicates less likelihood of cannabis use in the Late Sleep group)|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary cannabis use outcome (yes/no in the past 3 months), accounting for age and sex.||1.513|0.374|0.42
73832204|NCT03806296|147211726|SUPERIORITY||Risk Ratio (RR)|1.236||||0.461|TWO_SIDED|95.0|0.704|2.171|||Poisson GLM with robust standard error||Early/Middle Sleep group was the reference group (higher RR indicates higher likelihood of alcohol use in the Late Sleep group)|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary alcohol use outcome (yes/no in the past 3 months), accounting for age and sex.||2.171|0.704|0.461
73832205|NCT03806296|147211726|SUPERIORITY||Incident Rate Ratio|3.29||||0.007|TWO_SIDED|95.0|1.36|7.9|||negative binomial glm||Early/Middle Sleep group was the reference group (higher IRR indicates greater days of alcohol use in the Late Sleep group than in the Early/Middle Sleep group).|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a negative binomial GLM to test the effect of group (Early/Mid vs Late) on days of alcohol use, accounting for age and sex.||7.90|1.36|0.007
73832206|NCT02320175|147211729|OTHER|We compared percent top-box experience ratings pre- vs. post-intervention using a GEE chi-squared test for binary outcomes, clustered by site. Top-box score was calculated as the percentage of participants that gave the top-most response for the given survey item (e.g., 5=Extremely; 5=Excellent). Missing data was accounted for through use of multiple imputations appropriate for missing data in clustered studies.|||||<|0.05|||||||GEE chi-squared test for binary outcomes|||||||<.05
73832207|NCT00876343|147211735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.006|TWO_SIDED|95.0|-3.7|-0.6|||ANCOVA|||||-0.6|-3.7|0.006
73832208|NCT00876343|147211735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.6|-1.5|||ANCOVA|||||-1.5|-4.6|<0.001
73832209|NCT01933932|147211741|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.4355|TWO_SIDED|95.0|0.77|1.12|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.12|0.77|0.4355
73832210|NCT01933932|147211742|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.6431|TWO_SIDED|95.0|0.85|1.3|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.30|0.85|0.6431
73832211|NCT01933932|147211743|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.0515|TWO_SIDED|95.0|1.0|2.62|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation||||2.62|1.00|0.0515
73832212|NCT01933932|147211745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.5007|TWO_SIDED|95.0|0.74|1.86|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation||||1.86|0.74|0.5007
73832213|NCT01933932|147211746|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.3438|TWO_SIDED|95.0|0.74|1.11|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.11|0.74|0.3438
73832214|NCT05258721|147211747|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
73832215|NCT05258721|147211748|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p =0.05|Kruskal-Wallis|||||||<0.001
73832216|NCT05258721|147211749|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
73832217|NCT00230737|147211751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3594.0|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
73832218|NCT00848185|147211752|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||ANOVA for three groups||||<0.001
73832219|NCT00790036|147211812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.276|TWO_SIDED|95.0|0.69|1.22||P-value was obtained from the one-sided unstratified log rank test.|Log Rank|||||1.22|0.69|0.276
73832220|NCT00790036|147211813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.52|1.09||There was no formal testing of the OS between treatment since the primary endpoint was not statistically significant.||||||1.09|0.52|
73832221|NCT00790036|147211814|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.41|1.07||||||||1.07|0.41|
73832222|NCT04235374|147211858|SUPERIORITY||Mean Difference (Final Values)|0.06|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
73832223|NCT04235374|147211859|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
73832224|NCT04235374|147211860|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
73832225|NCT04235374|147211861|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
73832226|NCT04235374|147211862|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
73832227|NCT02595892|147211865|OTHER||Hazard Ratio (HR)|0.57||||0.044|TWO_SIDED|90.0|0.33|0.98|||Log Rank|||||.98|.33|0.044
73832228|NCT02595892|147211868|OTHER|||||||0.44|||||||Fisher Exact|Two-Sided Fisher's exact test.||||||0.44
73832229|NCT04717557|147211938|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
73832230|NCT04717557|147211938|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
73832231|NCT04717557|147211939|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
73832232|NCT04717557|147211940|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
73832233|NCT04717557|147211941|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|t-test, 2 sided|||||||>0.5
73832234|NCT04717557|147211942|SUPERIORITY||||||>|0.5|||||||Cochran-Mantel-Haenszel|||Underpowered - no statistically significant difference.||||>0.5
73832235|NCT04717557|147211943|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
73832236|NCT04717557|147211944|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
73832237|NCT04717557|147211945|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
73832238|NCT04717557|147211946|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
73832239|NCT02516241|147211979|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0751|TWO_SIDED|98.66|0.688|1.063||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.063|0.688|0.0751
73832240|NCT02516241|147211980|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.3039|TWO_SIDED|96.99|0.695|1.139||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.139|0.695|0.3039
73832241|NCT02516241|147211981|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.8637|TWO_SIDED|95.0|0.83|1.169||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.169|0.830|0.8637
73832242|NCT02516241|147211982|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0091|TWO_SIDED|95.0|0.589|0.928||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.928|0.589|0.0091
73832243|NCT02516241|147211983|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7599|TWO_SIDED|95.0|0.799|1.359||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.359|0.799|0.7599
73832244|NCT02516241|147211983|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.4424|TWO_SIDED|95.0|0.692|1.175||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.175|0.692|0.4424
73832245|NCT02516241|147211987|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.2579|TWO_SIDED|95.0|0.931|1.304||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.304|0.931|0.2579
73832246|NCT02516241|147211987|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.0008|TWO_SIDED|95.0|1.124|1.567||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.567|1.124|0.0008
73832247|NCT02516241|147211988|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.2395|TWO_SIDED|95.0|0.705|1.091||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.091|0.705|0.2395
73832248|NCT02516241|147211988|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.2431|TWO_SIDED|95.0|0.917|1.406||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.406|0.917|0.2431
73832249|NCT02516241|147211989|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.0014|TWO_SIDED|95.0|1.177|1.99||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.990|1.177|0.0014
73832250|NCT02516241|147211989|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6236|TWO_SIDED|95.0|0.729|1.209||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.209|0.729|0.6236
73832251|NCT02516241|147211993|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0477|TWO_SIDED|95.0|0.683|0.998||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.998|0.683|0.0477
73832252|NCT02516241|147211993|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7885|TWO_SIDED|95.0|0.809|1.175||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.175|0.809|0.7885
73832253|NCT02516241|147211994|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0053|TWO_SIDED|95.0|0.549|0.901||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.901|0.549|0.0053
73832254|NCT02516241|147211994|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1336|TWO_SIDED|95.0|0.651|1.059||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.059|0.651|0.1336
73832255|NCT02516241|147211995|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8148|TWO_SIDED|95.0|0.772|1.391||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.391|0.772|0.8148
73832256|NCT02516241|147211995|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.2684|TWO_SIDED|95.0|0.636|1.134||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.134|0.636|0.2684
73832257|NCT02516241|147211996|SUPERIORITY||Odds Ratio (OR)|0.58||||0.0005|TWO_SIDED|95.0|0.422|0.788||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.788|0.422|0.0005
73832258|NCT02516241|147211996|SUPERIORITY||Odds Ratio (OR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.253|0.485||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.485|0.253|<0.0001
73832259|NCT02516241|147211997|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7708|TWO_SIDED|95.0|0.639|1.394||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.394|0.639|0.7708
73832260|NCT02516241|147211997|SUPERIORITY||Odds Ratio (OR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.268|0.61||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.610|0.268|<0.0001
73832261|NCT02516241|147211998|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.135|0.406||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.406|0.135|<0.0001
73832262|NCT02516241|147211998|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6195|TWO_SIDED|95.0|0.469|1.566||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.566|0.469|0.6195
73832263|NCT02516241|147212000|SUPERIORITY||Odds Ratio (OR)|0.56||||0.0002|TWO_SIDED|95.0|0.41|0.759||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.759|0.410|0.0002
73832264|NCT02516241|147212000|SUPERIORITY||Odds Ratio (OR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.267|0.5||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.500|0.267|<0.0001
73832265|NCT02516241|147212001|SUPERIORITY||Odds Ratio (OR)|0.87||||0.4959|TWO_SIDED|95.0|0.59|1.291||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.291|0.590|0.4959
73832266|NCT02516241|147212001|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0001|TWO_SIDED|95.0|0.305|0.679||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.679|0.305|0.0001
73832267|NCT02516241|147212002|SUPERIORITY||Odds Ratio (OR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.16|0.448||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.448|0.160|<0.0001
73832268|NCT02516241|147212002|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8074|TWO_SIDED|95.0|0.623|1.836||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.836|0.623|0.8074
73832269|NCT02516241|147212003|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0008|TWO_SIDED|95.0|0.432|0.802||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.802|0.432|0.0008
73896613|NCT03930264|147326517|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of Cmax for tablet and suspension were required to be within the 80 to 125% range.|Odds Ratio (OR)|1.12||||0.3008|TWO_SIDED|90.0|0.93|1.35|||ANOVA|||||1.35|0.93|0.3008
73832270|NCT02516241|147212003|SUPERIORITY||Odds Ratio (OR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.27|0.512||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.512|0.270|<0.0001
73832271|NCT02516241|147212004|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7717|TWO_SIDED|95.0|0.639|1.394||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.394|0.639|0.7717
73832272|NCT02516241|147212004|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0001|TWO_SIDED|95.0|0.303|0.682||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.682|0.303|0.0001
73832273|NCT02516241|147212005|SUPERIORITY||Odds Ratio (OR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.151|0.439||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.439|0.151|<0.0001
73832274|NCT02516241|147212005|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9692|TWO_SIDED|95.0|0.556|1.759||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.759|0.556|0.9692
73832275|NCT02516241|147212013|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.1617|TWO_SIDED|95.0|-0.6|3.59||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||3.59|-0.6|0.1617
73832276|NCT02516241|147212013|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.0578|TWO_SIDED|95.0|-0.07|4.29||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||4.29|-0.07|0.0578
73832277|NCT02516241|147212013|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.2003|TWO_SIDED|95.0|-0.91|4.32||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||4.32|-0.91|0.2003
73832278|NCT02516241|147212013|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.0178|TWO_SIDED|95.0|0.57|6.0||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||6.00|0.57|0.0178
73832279|NCT02516241|147212013|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.3765|TWO_SIDED|95.0|-1.96|5.17||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||5.17|-1.96|0.3765
73832280|NCT02516241|147212013|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.03|TWO_SIDED|95.0|0.4|7.81||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||7.81|0.40|0.0300
73832281|NCT02516241|147212014|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.1373|TWO_SIDED|95.0|-0.6|4.36||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||4.36|-0.6|0.1373
73832282|NCT02516241|147212014|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.0034|TWO_SIDED|95.0|1.26|6.27||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||6.27|1.26|0.0034
73832283|NCT02516241|147212014|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.1774|TWO_SIDED|95.0|-1.0|5.39||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||5.39|-1.00|0.1774
73832284|NCT02516241|147212014|SUPERIORITY||Mean Difference (Final Values)|5.4||||0.0011|TWO_SIDED|95.0|2.19|8.65||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||8.65|2.19|0.0011
73832285|NCT02516241|147212014|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3494|TWO_SIDED|95.0|-2.27|6.38||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||6.38|-2.27|0.3494
73896614|NCT03930264|147326518|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-τ for tablet and suspension were required to be within the 80 to 125% range.|Ratio|1.06||||0.1061|TWO_SIDED|90.0|1.0|1.13|||ANOVA|||||1.13|1.00|0.1061
73896615|NCT03930264|147326519|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-∞ for tablet and suspension were required to be within the 80 to 125% range.|Ratio|1.02||||0.5696|TWO_SIDED|90.0|0.96|1.09|||ANOVA|||||1.09|0.96|0.5696
73832286|NCT02516241|147212014|SUPERIORITY||Mean Difference (Final Values)|7.3||||0.0011|TWO_SIDED|95.0|2.96|11.71||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||11.71|2.96|0.0011
73832287|NCT02516241|147212015|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.3865|TWO_SIDED|95.0|-4.35|1.69||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||1.69|-4.35|0.3865
73832288|NCT02516241|147212015|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.284|TWO_SIDED|95.0|-5.05|1.49||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||1.49|-5.05|0.2840
73832289|NCT02516241|147212015|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.297|TWO_SIDED|95.0|-5.41|1.66||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||1.66|-5.41|0.2970
73832290|NCT02516241|147212015|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.3026|TWO_SIDED|95.0|-5.85|1.83||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||1.83|-5.85|0.3026
73832291|NCT02516241|147212015|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.3168|TWO_SIDED|95.0|-7.29|2.38||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||2.38|-7.29|0.3168
73832292|NCT02516241|147212015|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.2179|TWO_SIDED|95.0|-8.51|1.96||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||1.96|-8.51|0.2179
73832293|NCT02516241|147212016|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2419|TWO_SIDED|95.0|0.8|2.6||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patients with improvement in fatigue||2.6|0.8|0.2419
73832294|NCT02516241|147212016|SUPERIORITY||Odds Ratio (OR)|1.5||||0.1553|TWO_SIDED|95.0|0.9|2.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||2.8|0.9|0.1553
73832295|NCT02516241|147212016|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0003|TWO_SIDED|95.0|1.4|2.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.8|1.4|0.0003
73832296|NCT02516241|147212016|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0148|TWO_SIDED|95.0|1.1|2.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.3|1.1|0.0148
73832297|NCT02516241|147212017|SUPERIORITY||Odds Ratio (OR)|1.6||||0.2473|TWO_SIDED|95.0|0.7|3.4||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.4|0.7|0.2473
73832298|NCT02516241|147212017|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0148|TWO_SIDED|95.0|0.8|3.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.8|0.8|0.0148
73832299|NCT02516241|147212017|SUPERIORITY||Odds Ratio (OR)|1.9||||0.009|TWO_SIDED|95.0|1.2|3.0||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patient with deterioration in pain||3.0|1.2|0.0090
73832300|NCT02516241|147212017|SUPERIORITY||Odds Ratio (OR)|1.4||||0.151|TWO_SIDED|95.0|0.9|2.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.3|0.9|0.1510
73832301|NCT02516241|147212018|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6763|TWO_SIDED|95.0|0.5|3.2||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.2|0.5|0.6763
73832302|NCT02516241|147212018|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6539|TWO_SIDED|95.0|0.5|3.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.3|0.5|0.6539
73832303|NCT02516241|147212018|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0092|TWO_SIDED|95.0|1.2|4.0||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patient with deterioration in pain||4.0|1.2|0.0092
73832304|NCT02516241|147212018|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0324|TWO_SIDED|95.0|1.1|3.5||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||3.5|1.1|0.0324
73832305|NCT00724945|147212019|SUPERIORITY_OR_OTHER||Least Square Mean|-0.08591|STANDARD_ERROR_OF_MEAN|0.008816||||95.0|-0.08591|-0.06857|||Mixed Models Analysis|||Alternative hypothesis: senofilcon A multifocal would be better than or equal to 0.1 logMAR units.||-0.06857|-0.08591|
73832306|NCT00724945|147212020|SUPERIORITY_OR_OTHER||Least Square Mean|0.02711|STANDARD_ERROR_OF_MEAN|0.008816||||97.5|0.02711|0.04445|||Mixed Models Analysis|||Alternative hypothesis: senofilcon A multifocal lens would be better than or equal to 0.17 logMAR units.||0.04445|0.02711|
73832307|NCT00724945|147212021|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is -0.5.|Mean Difference (Final Values)|0.07407|STANDARD_ERROR_OF_MEAN|0.1279||||97.5|-0.1797|0.07407|||Mixed Models Analysis||Mean difference was calculated as senofilcon A multifocal minus balafilcon A multifocal.|Alternative hypothesis: senofilcon A multifocal lens will have subjective vision that is non-inferior to balafilcon A multifocal.||0.07407|-0.1797|
73832308|NCT04835441|147212023|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|||||||0.107
73832309|NCT04835441|147212024|SUPERIORITY|||||||0.308|||||||Cochran-Mantel-Haenszel|||||||0.308
73832310|NCT04835441|147212025|SUPERIORITY|||||||0.442|||||||ANOVA|||||||0.442
73832311|NCT04835441|147212026|SUPERIORITY|||||||0.788|||||||Kaplan-Meier methods|||||||0.788
73832312|NCT04835441|147212027|SUPERIORITY|||||||0.792|||||||Cochran-Mantel-Haenszel|||||||0.792
73832313|NCT04835441|147212028|SUPERIORITY|||||||0.302|||||||Mixed models for repeated measures|||||||0.302
73832314|NCT04835441|147212029|SUPERIORITY|||||||0.506|||||||ANOVA|||||||0.506
73832315|NCT04835441|147212030|SUPERIORITY|||||||0.659|||||||Fisher Exact|||||||0.659
73832316|NCT04070703|147212094|SUPERIORITY|The co-primary outcome data were analyzed via a Group by Time mixed-effects model with repeated measures on the second factor (i.e., outcome measures assessed at baseline and 6 months. In the presence of a Group by Time interaction effect, pre-specified follow-up pair-wise comparisons were performed to determine between-group differences.|Mean Difference (Final Values)|2.8||||0.0125|TWO_SIDED|98.75|2.1|3.6|||Mixed Models Analysis|||||3.6|2.1|0.0125
73832317|NCT04070703|147212094|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.0125|TWO_SIDED|98.75|0.07|2.2|||Mixed Models Analysis|||||2.2|.07|.0125
73832318|NCT04070703|147212095|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.0125|TWO_SIDED|98.75|2.8|16.6|||Mixed Models Analysis|||||16.6|2.8|.0125
73832319|NCT04070703|147212095|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.0125|TWO_SIDED|98.75|12.6|31.2|||Mixed Models Analysis|||||31.2|12.6|.0125
73832320|NCT04070703|147212096|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.05|TWO_SIDED|95.0|-0.5|-0.1|||Mixed Models Analysis|||||-.1|-.5|0.05
73832321|NCT04070703|147212096|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.05|TWO_SIDED|95.0|-0.7|-0.3|||Mixed Models Analysis|||||-.3|-.7|.05
73832322|NCT04070703|147212097|SUPERIORITY||Mean Difference (Final Values)|-14.1||||0.05|TWO_SIDED|95.0|-20.0|-8.0|||Mixed Models Analysis|||||-8|-20|.05
73832323|NCT04070703|147212097|SUPERIORITY||Mean Difference (Final Values)|-22.0||||0.05|TWO_SIDED|95.0|-28.0|-16.0|||Mixed Models Analysis|||||-16|-28|.05
73832324|NCT04070703|147212098|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.05|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||.1|-.4|<.05
73832325|NCT04070703|147212098|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.05|TWO_SIDED|95.0|0.4|1.2|||Mixed Models Analysis|||||1.2|.4|<.05
73832326|NCT04070703|147212099|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.05|TWO_SIDED|95.0|0.5|1.6|||Mixed Models Analysis|||||1.6|.5|<.05
73832327|NCT04070703|147212099|SUPERIORITY||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|1.6|2.7|||Mixed Models Analysis|||||2.7|1.6|<.05
73832328|NCT04070703|147212100|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.05|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||||2.1|-.4|<.05
73832329|NCT04070703|147212100|SUPERIORITY||Mean Difference (Final Values)|4.4|||<|0.05|TWO_SIDED|95.0|3.1|5.0|||Mixed Models Analysis|||||5|3.1|<.05
73832330|NCT04070703|147212101|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||.7|-.3|<.05
73832331|NCT04070703|147212101|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.05|TWO_SIDED|95.0|-2.4|-1.4|||Mixed Models Analysis|||||-1.4|-2.4|<.05
73832332|NCT04070703|147212102|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.05|TWO_SIDED|95.0|-1.4|0.4|||Mixed Models Analysis|||||.4|-1.4|<.05
73832333|NCT04070703|147212102|SUPERIORITY||Mean Difference (Final Values)|1.7|||<|0.05|TWO_SIDED|95.0|0.8|2.3|||Mixed Models Analysis|||||2.3|.8|<.05
73832334|NCT04070703|147212103|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED|95.0|-0.1|1.1|||Mixed Models Analysis|||||1.1|-.1|<.05
73832335|NCT04070703|147212103|SUPERIORITY||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|1.6|2.8|||Mixed Models Analysis|||||2.8|1.6|<.05
73832336|NCT04070703|147212104|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.05|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis|||||.8|-.7|<.05
73832337|NCT04070703|147212104|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.05|TWO_SIDED|95.0|-3.1|-1.3|||Mixed Models Analysis|||||-1.3|-3.1|<.05
73832338|NCT04070703|147212105|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED|95.0|-0.3|1.2|||Mixed Models Analysis|||||1.2|-.3|<.05
73832339|NCT04070703|147212105|SUPERIORITY||Mean Difference (Final Values)|-1.0|||<|0.05|TWO_SIDED|95.0|-1.8|-0.2|||Mixed Models Analysis|||||-.2|-1.8|<.05
73832340|NCT04070703|147212106|SUPERIORITY||Mean Difference (Final Values)|1.4|||<|0.05|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||||2|-.4|<.05
73832341|NCT04070703|147212106|SUPERIORITY||Mean Difference (Final Values)|5.7|||<|0.05|TWO_SIDED|95.0|3.1|7.9|||Mixed Models Analysis|||||7.9|3.1|<.05
73832342|NCT04070703|147212107|SUPERIORITY||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.04|0.03|||Mixed Models Analysis|||||.03|-.04|<.05
73832343|NCT04070703|147212107|SUPERIORITY||Mean Difference (Final Values)|0.07|||<|0.05|TWO_SIDED|95.0|0.03|0.11|||Mixed Models Analysis|||||.11|.03|<.05
73832344|NCT04070703|147212108|SUPERIORITY||Mean Difference (Final Values)|4.0|||<|0.05|TWO_SIDED|95.0|-2.0|6.0|||Mixed Models Analysis|||||6|-2|<.05
73832345|NCT04070703|147212108|SUPERIORITY||Mean Difference (Final Values)|125.5|||<|0.05|TWO_SIDED|95.0|84.0|166.0|||Mixed Models Analysis|||||166|84|<.05
73832346|NCT04070703|147212109|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.05|TWO_SIDED|95.0|-0.3|-0.1|||Mixed Models Analysis|||||-.1|-.3|<.05
73832347|NCT04070703|147212109|SUPERIORITY||Mean Difference (Final Values)|-0.5|||<|0.05|TWO_SIDED|95.0|-0.7|-0.4|||Mixed Models Analysis|||||-.4|-.7|<.05
73832348|NCT00088153|147212113|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||After controlling for baseline age and weight changes|t-test, 2 sided|We also used a mixed model analysis of variance (PROC MIXED), to analyze longitudinal data.||Power analysis: We have previously demonstrated that normal female adolescents gain bone density at the rate of 0.039 +/- 0.0507 per year. The pooled SD in that study was 0.046. Based on these data, with a sample size of 110 girls with anorexia nervosa (AN), half of whom are randomized to receive estrogen and half placebo (with a 10% drop-out rate), there will be an 80% chance that we will detect an increase in bone density to 75% of normal in the girls who receive estrogen.||||<0.05
73832349|NCT00088153|147212114|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||The null hypothesis was that there would be no differences between the groups for changes in P1NP levels over time||||>0.05
73832350|NCT00088153|147212115|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||The p value was adjusted for age and weight changes|t-test, 2 sided|||The null hypothesis was that the groups would not differ for changes in spine bone density z-scores over the study duration||||<0.05
73832351|NCT04435626|147212127|SUPERIORITY||Rate ratio|0.84||||0.0072|TWO_SIDED|95.0|0.74|0.95||Two-sided p-value; p-value threshold =0.04967;|stratified Andersen-Gill model|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|Rate Ratio (Finerenone/Placebo)||0.95|0.74|0.0072
73832352|NCT04435626|147212129|SUPERIORITY||Rate ratio|0.82||||0.0062|TWO_SIDED|95.0|0.71|0.94||Two-sided p-value; p-value threshold=0.04967;|Stratified Andersen-Gill model|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|Rate Ratio (Finerenone/Placebo)||0.94|0.71|0.0062
73832353|NCT04435626|147212131|OTHER|mixed-effects model for repeated measures (MMRM)|Difference in LS Mean|1.56|||<|0.0001|TWO_SIDED|95.0|0.79|2.34||Two-sided p-value;|Mixed Models Analysis|The analysis was performed using mixed-effects model for repeated measures (MMRM)||Difference in LS Mean||2.34|0.79|<.0001
73832354|NCT04435626|147212132|OTHER|Logistic regression analysis|Odds Ratio (OR)|1.01||||0.9295|TWO_SIDED|95.0|0.88|1.15||Two-sided p-value|Regression, Logistic|||Odds ratio (finerenone /placebo)||1.15|0.88|0.9295
73832355|NCT04435626|147212133|OTHER|Stratified log-rank test|Cause-specific Hazard Ratio|1.33||||0.1071|TWO_SIDED|95.0|0.94|1.89||two-sided p-value|Stratified log-rank test||stratified Cox proportional hazards model|Cause-specific Hazard Ratio||1.89|0.94|0.1071
73832356|NCT04435626|147212134|OTHER|Stratified log-rank test|cause-specific hazard ratio|0.93||||0.2794|TWO_SIDED|95.0|0.83|1.06||two-sided p-value|stratified log-rank||stratified Cox proportional hazards model|Hazard Ratio||1.06|0.83|0.2794
73832357|NCT04426656|147212138|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using the outcome variable measured at Week 12.||||0.85
73832358|NCT04426656|147212139|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
73832359|NCT04426656|147212140|SUPERIORITY|||||||0.318|||||||Fisher Exact|||||||0.318
73832360|NCT04426656|147212141|SUPERIORITY|||||||0.527|||||||Fisher Exact|||||||0.527
73832361|NCT04426656|147212142|SUPERIORITY|||||||0.928|||||||Fisher Exact|||||||0.928
73832362|NCT04426656|147212143|SUPERIORITY|||||||0.678|||||||Fisher Exact|||||||0.678
73832363|NCT04426656|147212144|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||The comparison test was made using the outcome variable measured at Week 12.||||0.26
73832364|NCT04426656|147212145|SUPERIORITY|||||||0.08|||||||Fisher Exact|||The comparison was made using data measured at Week 12.||||0.08
73832365|NCT04426656|147212146|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using data measured at Week 12.||||0.03
73832366|NCT04426656|147212147|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||This comparison was made using data at Week 12.||||0.58
73832367|NCT04426656|147212148|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using data measured at Week 12.||||0.85
73832368|NCT04357795|147212185|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
73832369|NCT04357795|147212186|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
73832370|NCT04357795|147212187|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
73832371|NCT04357795|147212188|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
73832372|NCT04357795|147212189|OTHER|Single group analysis||||||0.0323|||||||Paired t-test|OD- Right eye p value||||||0.0323
73832373|NCT04357795|147212189|OTHER|Single group analysis||||||0.3447||||||OS: P-Value|Paired t-test|||||||0.3447
73832374|NCT04357795|147212190|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
73832375|NCT04357795|147212191|OTHER|Single group analysis||||||0.0029|||||||Paired t-test|||||||0.0029
73832376|NCT03785366|147212217|OTHER|"For the primary analysis, a ANOVA model with treatment as a fixed effect and subject as a random effect was used to analyze the uncorrected PK parameters Cmax, Cmean, and AUC0-56 days.~Analysis methodology for the secondary analysis mirrored the approach for the primary analysis applied to the baseline-corrected PK parameters."|test to Reference geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.8|1.25|||ANCOVA|||||1.25|0.80|
73832377|NCT05252702|147212239|SUPERIORITY|"The primary safety endpoint hypothesis at 3 months was formally expressed as:~H0: CFR ≤ 78% vs. H1: CFR \> 78%~where 78% was the performance goal (PG)."|binomial proportion|90.3|||<|0.0001|ONE_SIDED|97.5|87.0|||The CFR was estimated as a binomial proportion and a one-sided 97.5% lower confidence bound of the CFR was calculated using the normal approximation. The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG|one-sided Z-test|The p-value from a one-sided Z-test for the binomial proportion was calculated and compared to the 0.025 significance level.|||||87|<0.0001
73832378|NCT05252702|147212240|SUPERIORITY|"The primary safety endpoint hypothesis at 12 months was formally expressed as:~H0: CFR ≤ 76.5% vs. H1: CFR \> 76.5%~where 76.5% is the performance goal. The CFR was estimated using a Kaplan-Meier survival analysis and the 97.5% lower confidence bound of CFR was calculated using the Greenwood variance estimates."|Kaplan-Meier|88.6|||<|0.0001|ONE_SIDED|97.5|84.5|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 76.5%.|one-sided Z-test|The p-value for the one-sided Z-test was calculated and compared to the 2.5% significance level.|||||84.5|<0.0001
73832379|NCT05252702|147212241|SUPERIORITY||binomial proportion|90.8|||<|0.0001|ONE_SIDED|97.5|87.5|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 82.5%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.||"The primary effectiveness endpoint #1 hypothesis at 3 month was formally expressed as:~H0: Rate ≤ 82.5% vs. H1: Rate \> 82.5%~where 82.5% was the performance goal (PG)."|||87.5|<0.0001
73832380|NCT05252702|147212242|SUPERIORITY||binomial proportion|92.8|||<|0.0001|ONE_SIDED|97.5|89.7|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 80%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.|The Rate at 12 months was estimated as a binomial proportion and the one-sided 97.5% LCB of the Rate was calculated using the normal approximation.|"The primary effectiveness endpoint #1 hypothesis at 12 months was formally expressed as:~H0: Rate ≤ 80% vs. H1: Rate \> 80%~where 80% was the performance goal (PG)."|||89.7|<0.0001
73832381|NCT05252702|147212243|SUPERIORITY||binomial proportion|98.2|||<|0.0001|ONE_SIDED|97.5|96.6|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 83%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.||"The primary effectiveness endpoint #2 hypothesis was formally expressed as:~H0: RateAV ≤ 83% vs. H1: RateAV \> 83%~where 83% is the performance goal."|||96.6|<0.0001
73832382|NCT05252702|147212244|SUPERIORITY||binomial proportion|91.3||||0.0003|ONE_SIDED|97.5|88.1|||The null hypothesis was to be rejected at the 2.5% significance level if the lower confidence bound exceeded the Performance Goal (PG) of 84%.|one-sided Z-test|The p-value from a one-sided Z-test for the binomial proportion was to be calculated and compared to the 0.025 significance level.||"The secondary safety endpoint hypothesis at 3 months was formally expressed as:~H0: CFRA ≤ 84% vs. H1: CFRA \> 84%~where 84% was the performance goal."|||88.1|0.0003
73832383|NCT05252702|147212245|SUPERIORITY||Kaplan-Meier|91.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|ONE_SIDED|97.5|87.1|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 82%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.|The 97.5% lower confidence bound (LCB) of CFRA was calculated using the Greenwood variance estimates.|"The secondary safety endpoint hypothesis at 12 months was formally expressed as:~H0: CFRA ≤ 82% vs. H1: CFRA \> 82%~where 82% is the performance goal."|||87.1|<0.0001
73832384|NCT05252702|147212246|OTHER||mixed effects model for repeated measure|0.91|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.78|1.04|||t-test, 1 sided|Two one-sided t-tests (TOST), with an alpha level of 0.025, and n-1 degrees of freedom.||"An analysis of these data provided an estimate of the 95% confidence interval for the mean slope across analyzable subjects, which had a pre-specified success criterion requiring that this confidence interval must fall between slopes of 65% and 135%. The following hypothesis was evaluated:~H0: Mean Slope \< 0.65 or Mean Slope \> 1.35~H1: 0.65 ≤ Mean Slope ≤ 1.35"||1.04|0.78|<0.001
73832385|NCT04153864|147212247|NON_INFERIORITY|The Non-Inferiority Margin (NIM) was defined as 10% of the mean EPDS score in the Specialist group (8.91), which corresponded to a value of 0.89. This predetermined NIM of 10% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.36|||<|0.05|ONE_SIDED|95.0||0.86|||t-test, 1 sided|||Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 10% non-inferiority margin (NIM).||0.86||<0.05
73832386|NCT04153864|147212247|NON_INFERIORITY|The NIM was defined as 13% of the mean EPDS score in the In-Person group (8.92), which corresponded to a value of 1.16. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.23|||<|0.05|ONE_SIDED|95.0||0.77|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.||0.77||<0.05
73896616|NCT02434471|147326520|OTHER||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
73896617|NCT02434471|147326521|OTHER||Mean Difference (Final Values)|0.1||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
73832387|NCT04153864|147212247|NON_INFERIORITY|The NIM was defined as 13% of the mean EPDS score in the In-Person group (8.81), which corresponded to a value of 1.15. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.36|||<|0.05|ONE_SIDED|95.0||0.91|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this is per protocol analysis. Due to institutional pandemic-related restrictions, 21 participants were switched from In-Person to Telemedicine and met criteria for the per protocol analyses.||0.91||<0.05
73832388|NCT04153864|147212249|NON_INFERIORITY|The NIM was defined as 10% of the mean GAD-7 score for the Specialist group (6.36), which corresponded to a value of 0.64. This predetermined NIM of 10% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.08|||<|0.05|ONE_SIDED|95.0||0.57|||t-test, 1 sided|||Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 10% non-inferiority margin (NIM).This analysis was performed on 3-months post-randomization scores.||0.57||<0.05
73832389|NCT04153864|147212249|NON_INFERIORITY|The NIM was defined as 13% of the mean GAD-7 score in the In-Person group (6.29), which corresponded to a value of 0.82. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.14|||<|0.05|ONE_SIDED|95.0||0.73|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.||0.73||<0.05
73832390|NCT02629159|147212265|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|34.1|||<|0.001|TWO_SIDED|95.0|29.0|39.2||This comparison was the primary analysis for US/FDA regulatory purposes, and a ranked key secondary endpoint for EU/EMA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||39.2|29.0|<0.001
73832391|NCT02629159|147212265|SUPERIORITY||Response Rate Difference|7.5||||0.018|TWO_SIDED|95.0|1.2|13.8||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||13.8|1.2|0.018
73832392|NCT02629159|147212266|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|22.6|||<|0.001|TWO_SIDED|95.0|18.6|26.5||This comparison was the primary analysis for EU/EMA regulatory purposes, and a ranked key secondary endpoint for US/FDA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||26.5|18.6|<0.001
73832393|NCT02629159|147212266|SUPERIORITY||Response Rate Difference|10.7|||<|0.001|TWO_SIDED|95.0|5.3|16.1||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.1|5.3|<0.001
73832394|NCT02629159|147212267|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-1.33|||<|0.001|TWO_SIDED|95.0|-1.469|-1.194||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use, and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.194|-1.469|<0.001
73832395|NCT02629159|147212267|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.638|-0.295||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||-0.295|-0.638|<0.001
73832396|NCT02629159|147212268|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.97|-0.37||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.37|-0.97|<0.001
73832397|NCT02629159|147212268|SUPERIORITY||LS Mean Difference|0.14||||0.448|TWO_SIDED|95.0|-0.23|0.51||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||0.51|-0.23|0.448
73832398|NCT02629159|147212269|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.372|-0.253||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.253|-0.372|<0.001
73832399|NCT02629159|147212269|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.11||||0.004|TWO_SIDED|95.0|-0.184|-0.036||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||-0.036|-0.184|0.004
73832400|NCT02629159|147212270|NON_INFERIORITY|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Response Rate Difference|16.1|||||TWO_SIDED|95.0|9.9|22.3|||||Response Rate Difference = Upadacitinib - Adalimumab|||22.3|9.9|
73832401|NCT02629159|147212270|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|||||<|0.001||||||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.||||||<0.001
73832402|NCT02629159|147212270|SUPERIORITY||Response Rate Difference|30.3|||<|0.001|TWO_SIDED|95.0|25.6|35.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||35.0|25.6|<0.001
73832403|NCT02629159|147212271|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.33|||<|0.001|TWO_SIDED|95.0|3.52|5.15||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.15|3.52|<0.001
73832404|NCT02629159|147212271|SUPERIORITY||LS Mean Difference|1.62||||0.002|TWO_SIDED|95.0|0.62|2.62||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||2.62|0.62|0.002
73832405|NCT02629159|147212272|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|26.5|35.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||35.8|26.5|<0.001
73832406|NCT02629159|147212272|NON_INFERIORITY|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Response Rate Difference|16.3|||||TWO_SIDED|95.0|10.0|22.5|||||Response Rate Difference = Upadacitinib - Adalimumab|||22.5|10.0|
73832407|NCT02629159|147212272|SUPERIORITY||||||<|0.001||||||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use||||||<0.001
73832408|NCT02629159|147212273|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|24.1|||<|0.001|TWO_SIDED|95.0|19.4|28.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Placebo|||28.8|19.4|<0.001
73832409|NCT02629159|147212273|SUPERIORITY||Response Rate Difference|10.4||||0.001|TWO_SIDED|95.0|4.2|16.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.7|4.2|0.001
73832410|NCT02629159|147212274|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-44.04|||<|0.001|TWO_SIDED|95.0|-55.39|-32.69||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-32.69|-55.39|<0.001
73832411|NCT02629159|147212274|SUPERIORITY||LS Mean Difference|-9.92||||0.164|TWO_SIDED|95.0|-23.89|4.05||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||4.05|-23.89|0.164
73832412|NCT02629159|147212275|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.15|||<|0.001|TWO_SIDED|95.0|3.13|5.16||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate|Treatment Difference = Upadacitinib - Placebo|||5.16|3.13|<0.001
73832413|NCT02629159|147212275|SUPERIORITY||LS Mean Difference|1.51||||0.017|TWO_SIDED|95.0|0.27|2.76||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||2.76|0.27|0.017
73832414|NCT02629159|147212276|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-6.45|||<|0.001|TWO_SIDED|95.0|-9.63|-3.27||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-3.27|-9.63|<0.001
73832415|NCT02629159|147212276|SUPERIORITY||LS Mean Difference|-16.3|||<|0.001|TWO_SIDED|95.0|-18.89|-13.71||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-13.71|-18.89|<0.001
73832416|NCT02629159|147212277|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|7.5|||<|0.001|TWO_SIDED|95.0|3.0|12.1||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||12.1|3.0|<0.001
73832417|NCT02629159|147212277|SUPERIORITY||Response Rate Difference|-3.4||||0.187|TWO_SIDED|95.0|-8.2|1.5||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Adalimumab|||1.5|-8.2|0.187
73832418|NCT02629159|147212278|SUPERIORITY||Response Rate Difference|20.0|||<|0.001|TWO_SIDED|95.0|16.3|23.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||23.7|16.3|<0.001
73832419|NCT02629159|147212278|SUPERIORITY||Response Rate Difference|11.4|||<|0.001|TWO_SIDED|95.0|6.5|16.4||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.4|6.5|<0.001
73832420|NCT03033355|147212295|OTHER|||||||0.0012||||||Threshold for statistical significance used P-value \<0.05|Student t-Test|||Right Cingulate Body||||0.0012
73832421|NCT03033355|147212295|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Posterior Cingulate||||0.02
73832422|NCT03033355|147212295|OTHER|||||||0.0015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Anterior Cingulate||||0.0015
73832423|NCT03033355|147212295|OTHER|||||||0.0015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Right Prefrontal Cortex||||0.0015
73832424|NCT03033355|147212295|OTHER|||||||0.0138||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Insula||||0.0138
73832425|NCT03033355|147212295|OTHER|||||||0.049||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Pons Micturition Center||||0.049
73832426|NCT03033355|147212295|OTHER|||||||0.001||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Cerebellum||||0.001
73832427|NCT03033355|147212295|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Lentiform Nucleus||||0.026
73832428|NCT03033355|147212295|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Right Lentiform Nucleus||||0.026
73832429|NCT03033355|147212295|OTHER|||||||0.015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Amygdala/parahippocampal Gyrus||||0.015
73832430|NCT02685735|147212334|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without gabapentin treatment group. A statistically significant result is interpreted as evidence to support that the gabapentin treatment impacts some element of change after surgery (i.e, intercept or slope).||||||0.882||||||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the gabapentin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, age, sex, pupil diameter, and catastophizing-optimism construct.||||0.882
73896618|NCT00538785|147326584|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.746|||||TWO_SIDED|95.0|0.344|1.586|||Guess method|Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF||1.586|0.344|
73896619|NCT00538785|147326585|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.495|||||TWO_SIDED|95.0|0.101|1.989|||Guess method|Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF||1.989|0.101|
73832431|NCT02685735|147212340|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without gabapentin treatment group. A statistically significant result is interpreted as evidence to support that the gabapentin treatment impacts some element of change after surgery (i.e, intercept or slope).||||||0.137||||||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the gabapentin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, age, sex, pupil diameter, and catastrophizing-optimism construct.||||0.137
73832432|NCT02685735|147212341|SUPERIORITY||||||<|0.0001|||||||Chi-squared|14 degrees of freedom||The null hypothesis (H0) is that modeled trajectory of change in pain intensity report after total hip or total knee arthroplasty does not differ between oral gabapentin and placebo in a manner dependent on its interaction with preferred cognitive style and pre-surgery pupil resting diameter . The alternative hypothesis (H1) is that there is a difference between the two groups which is dependent on these interactions.|A likelihood ratio test was conducted to compare these two models, conditional on the difference in the degrees of freedom in both models. A statistically significant likelihood ratio test would be interpreted as evidence that the three mechanistic predictors (Catastrophising-Optimism construct, Study Group, resting Pupil diameter) impact some aspect of the change in pain that occurs after surgery. If a statistically significant effect is observed, the individual interaction parameters will be interpreted.|||<0.0001
73832433|NCT05965427|147212342|SUPERIORITY|||||||0.097|||||||Chi-squared|||||||0.097
73832434|NCT05965427|147212343|SUPERIORITY|||||||0.005|||||||Chi-squared|||"Statistical analysis of Any of the specified clinical complications measure"||||0.005
73832435|NCT05965427|147212344|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
73832436|NCT05965427|147212346|SUPERIORITY|||||||0.002|||||||Chi-squared|||"Statistical analysis relates to not presenting with skin lesions measure"||||0.002
73832437|NCT05965427|147212350|SUPERIORITY|||||||0.114|||||||Chi-squared|||"Statistical analysis relates to any drug treatment for mpox measure"||||0.114
73832438|NCT05965427|147212351|SUPERIORITY||||||<|0.001|||||||Chi-squared|||"Statistical analysis relates to any drug for complications measure"||||<0.001
73832439|NCT05965427|147212352|SUPERIORITY|"Statistical analysis relates to lesion onset measure"|||||<|0.001|||||||Chi-squared|||||||<0.001
73832440|NCT02101788|147212366|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.28|1.07|||||Estimation of treatment effect; Trametinib vs. SOC among patients with a mutation.|||1.07|0.28|
73832441|NCT02101788|147212366|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.39|1.03|||||Estimation of treatment effect; Trametinib vs. SOC among wild-type patients.|||1.03|0.39|
73832442|NCT02101788|147212366|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0929|TWO_SIDED|95.0|0.34|1.08|||Chi-squared||Estimation of mutation effect; mutant vs. wild-type in the SOC group.|Prognostic effect of the mutation status among patients in the SOC arm.||1.08|0.34|0.0929
73832443|NCT02101788|147212366|SUPERIORITY|||||||0.7195|||||||Chi-squared|||Predictive effect biomarker p-value||||0.7195
73832444|NCT00927472|147212373|SUPERIORITY_OR_OTHER|||||||0.0386|||||||t-test, 2 sided|||||||0.0386
73832445|NCT00927472|147212374|SUPERIORITY_OR_OTHER|||||||0.3675|||||||t-test, 2 sided|||||||0.3675
73832446|NCT00927472|147212375|SUPERIORITY_OR_OTHER|||||||0.049|||||||t-test, 2 sided|||||||0.0490
73832447|NCT00927472|147212376|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
73832448|NCT00927472|147212377|SUPERIORITY_OR_OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
73832449|NCT00927472|147212378|SUPERIORITY_OR_OTHER|||||||0.0012|||||||t-test, 2 sided|||||||0.0012
73832450|NCT00927472|147212379|SUPERIORITY_OR_OTHER|||||||0.3817|||||||t-test, 2 sided|||||||0.3817
73832451|NCT00927472|147212380|SUPERIORITY_OR_OTHER|||||||0.1059|||||||t-test, 2 sided|||||||0.1059
73832452|NCT00927472|147212381|SUPERIORITY_OR_OTHER|||||||0.1088|||||||t-test, 2 sided|||||||0.1088
73832453|NCT00927472|147212382|SUPERIORITY_OR_OTHER|||||||0.1527|||||||t-test, 2 sided|||||||0.1527
73832454|NCT02512419|147212385|SUPERIORITY||regression parameter (median diff)|37.52|STANDARD_ERROR_OF_MEAN|18.01||0.04|TWO_SIDED||||||quantile regression|Models regressed outcome at 6 months on treatment assigned, baseline value of the outcome and actigraph wear time. Effect sizes reported are adjusted|Effects are unstandardized regression coefficients. They represent difference in median outcome between conditions at 6m controlling for baseline and covariates.|To examine potential intervention effects on the primary outcome (MVPA at 6 months), we used a series of quantile regression models which model median outcome at follow-up as a function of baseline value of the outcome (MVPA), treatment condition and covariates. Note that the adjusted difference in median MVPA between conditions at follow-up will not equal the difference in median minutes as seen in the unadjusted tables as these estimates are adjusted||||.04
73832455|NCT02512419|147212386|SUPERIORITY||Median Difference (Final Values)|42.36|STANDARD_ERROR_OF_MEAN|38.83||0.1|TWO_SIDED||||||quantile regression|||Quantile regression was used.||||0.10
73832456|NCT02290184|147212396|SUPERIORITY_OR_OTHER|A multi-level regression was employed to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected confidence interval (CI).|cross-level interaction|-2.0|||||TWO_SIDED|0.05|-3.0|-1.1|||||"Multilevel regression analysis was used. The primary test of between-group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the active control from baseline to 3-months.||-1.1|-3.0|
73832457|NCT02290184|147212397|SUPERIORITY|Multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.6|||||TWO_SIDED|0.05|-3.9|-1.4|||||"Multilevel regression was used. The primary test of between group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months||-1.4|-3.9|
73832458|NCT02290184|147212398|SUPERIORITY|A multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.7|||||TWO_SIDED|95.0|-4.5|-0.91|||||"Multilevel regression was used. The primary test of between -group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in waist-circumference (cm) compared to the Active Control from baseline to 3-months||-.91|-4.5|
73832459|NCT01069939|147212399|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.09|||<|0.001|TWO_SIDED|96.65|0.02|0.41||An interim analysis was done so that the significance level was adjusted using the Pocock-like alpha-spending function with Lan-DeMets approach. The adjusted significance level was the two-sided 3.35%.|Log Rank|||The above two groups were compared.||0.41|0.02|<0.001
73832460|NCT01017250|147212425|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.04
73832461|NCT01017250|147212426|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.002
73832462|NCT01017250|147212427|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.02
73832463|NCT01017250|147212428|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.0005
73832464|NCT01017250|147212429|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.53
73832465|NCT01017250|147212430|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.002
73832466|NCT01017250|147212431|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.76
73832467|NCT01017250|147212432|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.34
73832468|NCT00191100|147212436|SUPERIORITY_OR_OTHER||PFS Probability Difference at 3 Years|0.095||||0.029||95.0|0.01|0.179||The p-value is two-sided and was tested at the 0.05 significance level.|Z Statistic||Difference in progression-free survival probability between Gem/Cis/Rad and Cis/Rad. The difference in PFS probability between the two treatment arms can also be presented as a percentage (ie, PFS at 3 years was 9.5% better in the Gem/Cis/Rad arm).|||0.179|0.010|0.029
73832469|NCT00191100|147212437|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Log Rank|||||||0.0008
73832470|NCT00191100|147212438|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact|||"Note: There were 2 patients with unknown site of progressive disease; these patients were counted as a Local failure.~Note: There was 1 patient with both local and distant failure; this patient was counted as a Local failure."||||0.096
73832471|NCT00191100|147212439|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact|||||||0.250
73832472|NCT00191100|147212440|SUPERIORITY_OR_OTHER|||||||0.0224||95.0|||||Log Rank|||||||0.0224
73832473|NCT00191100|147212441|SUPERIORITY_OR_OTHER|||||||0.0227||95.0|||||Log Rank|||||||0.0227
73832474|NCT01525589|147212446|SUPERIORITY|||||||0.0909|||||||Log Rank|||||||0.0909
73832475|NCT01525589|147212450|SUPERIORITY|||||||0.002|||||||Log Rank|||||||0.002
73832476|NCT01525589|147212454|SUPERIORITY|||||||0.0561|||||||Log Rank|||||||0.0561
73832477|NCT03323502|147212519|SUPERIORITY||Incidence Rate Ratio (IRR)|0.94|STANDARD_ERROR_OF_MEAN|0.062||0.3164|TWO_SIDED|95.0|0.83|1.06|||Poisson Regression|||||1.06|0.83|0.3164
73832478|NCT03323502|147212520|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4828|TWO_SIDED|95.0|0.8|1.11|||Regression, Logistic|||||1.11|0.80|0.4828
73832479|NCT03323502|147212521|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3946|TWO_SIDED|95.0|0.85|1.49|||Regression, Logistic|||||1.49|0.85|0.3946
73832480|NCT00975923|147212567|SUPERIORITY_OR_OTHER||infection rates per device days|2.0|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED|95.0|1.0|3.0||p-value and confidence intervals|Regression, Linear|||Infection rates were analyzed using hierarchical negative binomial regression models to model infection rate changes over time and account for clustering of ICUs within hospitals and adjusting for baseline covariates. Power was calculated a priori with a 1-tailed alpha of 0.05 and group size of 30; a 50% decrease in infection rates in the Collaborative group and 15% for the Tool Kit group, yielding power ranging from 82% to 91% for testing group differences.||3.0|1.0|<.05
73832481|NCT00975923|147212568|SUPERIORITY_OR_OTHER||percentages|10.0|||<|5|TWO_SIDED|95.0|||||Chi-squared||Power calculation used alpha = .05 and group size = 30.The estimated effect was a 50% decrease in infection rates for the Collaborative Group and from 10% to 15% decrease in the Tool Kit group.Power ranged from 82%-91% for testing group differences.|It was hypothesized that the Collaborative group would engage in more processes and tools than the Tool Kit group. Power was based on infection rates.||||<05
73832482|NCT04896385|147212570|OTHER|||||||0.004|||||||repeated measures correlation|||F-VASI||||0.004
73832483|NCT04896385|147212570|OTHER|||||||0.41|||||||repeated measures correlation|||F-VASI||||0.41
73832484|NCT04896385|147212570|OTHER|||||||0.0002|||||||repeated measures correlation|||T-VASI||||0.0002
73832485|NCT04896385|147212570|OTHER|||||||0.91|||||||repeated measures correlation|||T-VASI||||0.91
73832486|NCT02612155|147212607|OTHER|||||||0.06|||||||Fisher Exact|||||||0.06
73832487|NCT00569127|147212640|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.55|TWO_SIDED|95.0|0.73|1.18||Central-review based progression-free survival was analyzed using the stratified log rank test (which is the score test from the stratified Cox-model) using stratification factors as defined in Section 6.0.|Regression, Cox||The reported hazard ratio estimate is for the comparison of the Octreotide, Bevacizumab arm to the Octreotide, Interferon Alpha-2b arm.|According to the intent-to-treat principle, all eligible patients were included in the analysis according to the randomized treatment assignment, regardless of actual treatments received.||1.18|0.73|0.55
73832488|NCT06442800|147212645|SUPERIORITY||Mean Difference (Final Values)|1.31|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
73832489|NCT06442800|147212645|SUPERIORITY||Mean Difference (Final Values)|1.19|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
73832490|NCT06442800|147212645|SUPERIORITY||Mean Difference (Final Values)|1.17|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
73832491|NCT06442800|147212645|SUPERIORITY||Mean Difference (Final Values)|1.15|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
73832492|NCT06442800|147212645|SUPERIORITY||Mean Difference (Final Values)|1.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
73832493|NCT06442800|147212645|SUPERIORITY||Mean Difference (Final Values)|1.11|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
73832494|NCT06442800|147212645|SUPERIORITY||Mean Difference (Final Values)|0.98|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
73832495|NCT06442800|147212645|SUPERIORITY||Mean Difference (Final Values)|0.81|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||<0.001
73832496|NCT06442800|147212645|SUPERIORITY||Mean Difference (Final Values)|0.58|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
73832497|NCT06442800|147212646|SUPERIORITY||Mean Difference (Final Values)|1.75|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
73832498|NCT06442800|147212646|SUPERIORITY||Mean Difference (Final Values)|1.59|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
73832499|NCT06442800|147212646|SUPERIORITY||Mean Difference (Final Values)|1.54|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
73832500|NCT06442800|147212646|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
73832501|NCT06442800|147212646|SUPERIORITY||Mean Difference (Final Values)|1.66|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
73832502|NCT06442800|147212646|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
73832503|NCT06442800|147212646|SUPERIORITY||Mean Difference (Final Values)|1.45|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
73832504|NCT06442800|147212646|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||<0.001
73832505|NCT06442800|147212646|SUPERIORITY||Mean Difference (Final Values)|0.93|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
73832506|NCT06442800|147212647|SUPERIORITY||Difference in predicted proportions|0.38|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
73832507|NCT06442800|147212647|SUPERIORITY||Difference in predicted proportions|0.34|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
73832508|NCT06442800|147212647|SUPERIORITY||Difference in predicted proportions|0.4|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
73832509|NCT06442800|147212647|SUPERIORITY||Difference in predicted proportions|0.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
73832510|NCT06442800|147212647|SUPERIORITY||Difference in predicted proportions|0.37|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
73832511|NCT06442800|147212647|SUPERIORITY||Difference in predicted proportions|0.11|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
73832512|NCT06442800|147212647|SUPERIORITY||Difference in predicted proportions|0.25|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
73832513|NCT06442800|147212647|SUPERIORITY||Difference in predicted proportions|0.04||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||0.02
73832514|NCT06442800|147212647|SUPERIORITY||Difference in predicted proportions|0.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
73832515|NCT06354257|147212662|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.55|1.41|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of EE.||1.41|0.55|
73832516|NCT06354257|147212662|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|1.1|||||TWO_SIDED|90.0|0.98|1.23|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of LNG.||1.23|0.98|
73832517|NCT06354257|147212663|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.85|1.09|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of EE.||1.09|0.85|
73832518|NCT06354257|147212663|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.97|1.19|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of LNG.||1.19|0.97|
73832519|NCT04738487|147212739|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6712|TWO_SIDED|95.0|0.83|1.35||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.35|0.83|0.6712
73832520|NCT04738487|147212740|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.332|TWO_SIDED|95.0|0.82|1.13||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.13|0.82|0.3320
73832521|NCT04738487|147212741|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1646|TWO_SIDED|95.0|0.72|1.11||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.11|0.72|0.1646
73832522|NCT04635423|147212794|SUPERIORITY||Observed Efficacy (%)|89.3|||<|0.001|TWO_SIDED|95.0|55.4|98.2||one-sided p-value based on exact binomial method proposed by Chan and Bohidar|Exact Binomial Method Chan and Bohidar||The statistical criterion for success requires that the lower bound of the 2-sided 95% confidence interval (CI) for vaccine efficacy (VE) against the primary efficacy endpoint is greater than 0%.|||98.2|55.4|<0.001
73832523|NCT04635423|147212795|OTHER||Difference in Percentages|40.1|||||TWO_SIDED|95.0|34.5|45.5|||Miettinen & Nurminen method||Difference in percentages calculated as % V503 minus % Placebo.|||45.5|34.5|
73832524|NCT04635423|147212796|OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-4.4|5.2|||Miettinen & Nurminen method||Difference in percentages calculated as % V503 minus % Placebo.|||5.2|-4.4|
73832525|NCT04635423|147212799|SUPERIORITY||Observed Efficacy (%)|63.5||||0.023|TWO_SIDED|95.0|2.7|86.0||one-sided p-value based on exact binomial method proposed by Chan and Bohidar|Exact Binomial Method Chan and Bohidar||The statistical criterion for success requires that the lower bound of the 2-sided 95% confidence interval (CI) for vaccine efficacy (VE) against the primary efficacy endpoint is greater than 0%.|||86.0|2.7|0.023
73832526|NCT03824158|147212847|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
73832527|NCT03824158|147212848|SUPERIORITY|||||||0.76|||||||Regression, Logistic|||||||0.76
73832528|NCT03824158|147212849|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
73832529|NCT03824158|147212850|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
73832530|NCT03824158|147212851|SUPERIORITY|||||||0.002|||||||Chi-squared|||Advance directive or living will||||0.002
73832531|NCT03824158|147212851|SUPERIORITY|||||||0.02|||||||Fisher Exact|||POLST||||0.02
73832532|NCT03824158|147212851|SUPERIORITY|||||||0.78|||||||Chi-squared|||Code Status||||0.78
73832533|NCT03824158|147212851|SUPERIORITY|||||||0.61|||||||Chi-squared|||Goals of Care discussion||||0.61
73832534|NCT03824158|147212852|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
73832535|NCT03824158|147212853|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
73832536|NCT05119569|147212889|SUPERIORITY||Rate Ratio|0.313||||0.0022|TWO_SIDED|95.0|0.149|0.658|||Negative Binomial Regression Model|||||0.658|0.149|0.0022
73832537|NCT05119569|147212890|SUPERIORITY||Rate Ratio|0.265||||0.0004|TWO_SIDED|95.0|0.128|0.55|||Negative Binomial Regression Model|||||0.550|0.128|0.0004
73832538|NCT05119569|147212891|SUPERIORITY||Odds Ratio (OR)|4.005||||0.0117|TWO_SIDED|95.0|1.317|13.078|||Logistic Regression Model|||||13.078|1.317|0.0117
73832539|NCT05119569|147212896|SUPERIORITY||Rate Ratio|0.78||||0.5889|TWO_SIDED|95.0|0.316|1.922|||Negative Binomial Regression Model|||||1.922|0.316|0.5889
73832540|NCT05119569|147212897|SUPERIORITY||Rate Ratio|0.076||||0.0011|TWO_SIDED|95.0|0.016|0.355|||Negative Binomial Regression Model|||||0.355|0.016|0.0011
73832541|NCT05119569|147212898|SUPERIORITY||Rate Ratio|0.104||||0.0038|TWO_SIDED|95.0|0.022|0.481|||Negative Binomial Regression Model|||||0.481|0.022|0.0038
73832542|NCT05119569|147212899|SUPERIORITY||Rate Ratio|0.512||||0.0958|TWO_SIDED|95.0|0.233|1.126|||Negative Binomial Regression Model|||||1.126|0.233|0.0958
73832543|NCT05119569|147212900|SUPERIORITY||Rate Ratio|0.105|||<|0.0001|TWO_SIDED|95.0|0.039|0.283|||Negative Binomial Regression Model|||||0.283|0.039|<0.0001
73832544|NCT05119569|147212901|SUPERIORITY||Rate Ratio|0.053||||0.0001|TWO_SIDED|95.0|0.012|0.233|||Negative Binomial Regression Model|||||0.233|0.012|0.0001
73832545|NCT03488524|147212910|SUPERIORITY||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|1.87||0.0239|TWO_SIDED|95.0|0.56|7.9||Significance testing was 2-tailed and considered statistically significant if the calculated p-value was ≤0.05.|Mixed Models Analysis|Random-slope, shared-baseline, linear mixed model was adjusted for age and prebaseline ALSFRS-R slope.||Participants who did not enter the open-label extension (OLE) were included in this analysis.||7.90|0.56|0.0239
73832546|NCT03488524|147212911|SUPERIORITY||Hazard Ratio (HR)|0.644||||0.0475|TWO_SIDED|95.0|0.416|0.995|||Hazard ratio|||Cox Proportional Hazards analysis||0.995|0.416|0.0475
73832547|NCT03488524|147212912|SUPERIORITY||Hazard Ratio (HR)|0.621||||0.0308|TWO_SIDED|95.0|0.403|0.957|||Hazard Ratio|||||0.957|0.403|0.0308
73832548|NCT03488524|147212913|SUPERIORITY||Mean Difference (Final Values)|7.77|STANDARD_ERROR_OF_MEAN|3.55||0.0291|TWO_SIDED|95.0|0.8|14.75|||Mixed Models Analysis|||||14.75|0.80|0.0291
73832549|NCT03488524|147212914|SUPERIORITY||Mean Difference (Final Values)|4.76|STANDARD_ERROR_OF_MEAN|3.923||0.2261|TWO_SIDED|95.0|-2.95|12.47|||Mixed Models Analysis|||||12.47|-2.95|0.2261
73832550|NCT03488524|147212915|SUPERIORITY||Mean Difference (Final Values)|10.66|STANDARD_ERROR_OF_MEAN|5.103||0.0372|TWO_SIDED|95.0|0.63|20.69||Nominal p-value|Mixed Models Analysis|||||20.69|0.63|0.0372
73832551|NCT03488524|147212916|SUPERIORITY|||||||0.0503||||||Nominal p-value|Mixed Models Analysis|||||||0.0503
73832552|NCT00434434|147212923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.13
73832553|NCT00434434|147212923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.0133
73832554|NCT00434434|147212924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.09
73832555|NCT00434434|147212924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.0028
73832556|NCT01922934|147212925|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
73832557|NCT02354118|147212933|NON_INFERIORITY|10% non-inferiority margin||||||1|||||||Chi-squared|||||||1.0
73832558|NCT01706328|147212963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.137|TWO_SIDED|95.0|-0.008|0.059|||ANCOVA|||||0.059|-0.008|0.137
73832559|NCT03160170|147212966|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
73832560|NCT03160170|147212967|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
73832561|NCT03160170|147212968|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
73832562|NCT03018938|147212969|NON_INFERIORITY|If Lower limit (L) \>-0.4%, the Non-inferiority (NI) of basal insulin analog QD to insulin analog mid mixture BID is established; If Upper limit (U) \<0.4%, the NI of insulin analog mid mixture BID to basal insulin analog QD is established|LS Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.0959||0.1009|TWO_SIDED|95.0|-0.346|0.031|||ANCOVA|||||0.031|-0.346|0.1009
73832563|NCT03018938|147212970|SUPERIORITY||LS Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.0891||0.0246|TWO_SIDED|95.0|-0.376|-0.026|||ANCOVA|||||-0.026|-0.376|0.0246
73832564|NCT03018938|147212971|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0941|TWO_SIDED|95.0|0.95|1.87|||Regression, Logistic|||||1.87|0.95|0.0941
73832565|NCT03018938|147212972|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8592|TWO_SIDED|95.0|0.72|1.49|||Regression, Logistic|||||1.49|0.72|0.8592
73832566|NCT03018938|147212973|SUPERIORITY||LS Mean Difference (Final Values)|0.423|STANDARD_ERROR_OF_MEAN|0.2152||0.0497|TWO_SIDED|95.0|0.0|0.846|||ANCOVA|||||0.846|0.000|0.0497
73832567|NCT03018938|147212974|SUPERIORITY||LS Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.1955||0.001|TWO_SIDED|95.0|0.263|1.031|||ANCOVA|||||1.031|0.263|0.0010
73832568|NCT03018938|147212975|SUPERIORITY||LS Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.2191||0.2193|TWO_SIDED|95.0|-0.161|0.7|||ANCOVA|||FBG||0.700|-0.161|0.2193
73832569|NCT03018938|147212975|SUPERIORITY||LS Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.3331||0.8014|TWO_SIDED|95.0|-0.739|0.571|||ANCOVA|||PPG||0.571|-0.739|0.8014
73832570|NCT03018938|147212976|SUPERIORITY||LS Mean Difference (Final Values)|0.491|STANDARD_ERROR_OF_MEAN|0.2033||0.016|TWO_SIDED|95.0|0.092|0.891|||ANCOVA|||FBG||0.891|0.092|0.0160
73832571|NCT03018938|147212976|SUPERIORITY||LS Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.3028||0.9661|TWO_SIDED|95.0|-0.608|0.582|||ANCOVA|||PPG||0.582|-0.608|0.9661
73832572|NCT03018938|147212978|SUPERIORITY||LS Mean Difference|0.667|STANDARD_ERROR_OF_MEAN|0.2776||0.0166|TWO_SIDED|95.0|0.122|1.211|||ANCOVA|||||1.211|0.122|0.0166
73832573|NCT03018938|147212979|SUPERIORITY||LS Mean Difference (Final Values)|0.754|STANDARD_ERROR_OF_MEAN|0.2864||0.0086|TWO_SIDED|95.0|0.192|1.316|||ANCOVA|||||1.316|0.192|0.0086
73832574|NCT03018938|147212982|SUPERIORITY||Odds Ratio (OR)|1.25||||0.2009|TWO_SIDED|95.0|0.89|1.77|||Regression, Logistic|||||1.77|0.89|0.2009
73832575|NCT03018938|147212983|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8054|TWO_SIDED|95.0|0.72|1.53|||Regression, Logistic|||||1.53|0.72|0.8054
73832576|NCT03018938|147212984|SUPERIORITY||LS Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.7553|TWO_SIDED|95.0|-0.8|0.5|||Mixed Models Analysis|||||0.5|-0.8|0.7553
73832577|NCT01769586|147212985|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.38|||<|0.001|TWO_SIDED|95.0|0.24|0.5|||Chi-squared|||||.50|.24|<0.001
73832578|NCT00373672|147213128|SUPERIORITY||||||<|0.016|||||||t-test, 2 sided|||Treatment effects were analyzed using a repeated measures analysis of variance model with time (baseline, 6 weeks) as the within-subjects factor and treatment group (armodafinil, placebo) as the between-subjects factor.||||<0.016
73832579|NCT04871074|147213129|SUPERIORITY|||||||0.74|||||||DeLong's Test|||||||.74
73832580|NCT04871074|147213130|SUPERIORITY|||||||0.66|||||||DeLong's Test|||||||.66
73832581|NCT04871074|147213131|SUPERIORITY|||||||0.135|||||||Mixed Models Analysis|Linear mixed effects model, fixed effects coefficient test with a Wald test||||||.135
73832582|NCT04871074|147213135|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|Fixed effects estimate, Wald test||||||.39
73832583|NCT00098475|147213148|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The low-dose response would be considered unacceptable if the difference in response rates was 15% or greater (the upper confidence limit exceeds the 15% acceptable difference) regardless of a decrease in toxicity rate.|Difference in response rate between arms|0.107|||||TWO_SIDED|80.0|0.052|0.162||||||The study was designed to determine if a reduced dose of dexamethasone in combination with CC-5013 reduced toxicity rate without reducing response rate. The standard-dose response was expected to be 70%. The low dose would be deemed unacceptable if the difference in response rate between arms was \>=15%. The null hypothesis was that response rates were equal and the alternative was that the low-dose response was no worse than 55%. The design had a 1-sided 0.10 type I error rate and 95% power.||0.162|0.052|
73832584|NCT04132050|147213150|SUPERIORITY||Difference in Percent of Participants|36.4||||0.03|TWO_SIDED|95.0|3.1|59.3|||Fisher Exact||"The difference in the achievement rate of Stable platelet response (= platelet count of ≥ 50000/μL at 4 or more of the 6 visits from Weeks 14 to 24) between two groups and its two-sided 95% CI were calculated."|||59.3|3.1|0.030
73832585|NCT00843882|147213155|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
73832586|NCT00843882|147213164|SUPERIORITY|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||||||0.0002
73832587|NCT05317546|147213168|SUPERIORITY|We used linear mixed effects models containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) with random intercepts. For 1H-MRS models, brain tissue composition \[Gray Matter: Brain Matter or GM:BM defined as GM/(GM+WM)\] was included as a covariate.||||||0.33||||||alpha \< 0.05|Mixed Models Analysis|Adjusted for brain tissue composition||An a priori power analysis was conducted to ensure power to detect differences in neurometabolite levels in the dACC. Due to type of modeling, participants were included even if they did not complete the second medication allocation.||||0.33
73832588|NCT05317546|147213169|SUPERIORITY|We used linear mixed effects models containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) with random intercepts. For 1H-MRS models, brain tissue composition \[Gray Matter: Brain Matter or GM:BM defined as GM/(GM+WM)\] was included as a covariate.||||||0.75||||||alpha \<0.05|Mixed Models Analysis|Adjusted for brain tissue composition||Due to type of modeling, participants were included even if they did not complete the second medication allocation.||||0.75
73832589|NCT05317546|147213170|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Several studies have demonstrated that CBD can modulate resting-state or task-based BOLD signal under similar study design (acute dosing, 600 mg CBD) with sample sizes smaller than our sample. Due to the modeling, only participants with usable data from both medication allocation visits were included. Contrast of interest was alcohol beverages vs. non-alcohol beverages.||||>0.05
73832590|NCT05317546|147213171|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||We were not able to complete a power calculation for this task. We used linear mixed effects models, containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) and cue-by-medication interaction terms. Random intercepts were included to account for individual differences.||||0.82
73832591|NCT05317546|147213172|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||We were not able to complete a power calculation for this task. We used linear mixed effects models, containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) and cue-by-medication interaction terms. Random intercepts were included to account for individual differences.||||0.21
73832592|NCT04590963|147213177|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.989|TWO_SIDED|95.0|0.66|1.537|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.537|0.660|0.989
73832593|NCT04590963|147213178|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.891|TWO_SIDED|95.0|0.704|1.528|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.528|0.704|0.891
73832594|NCT04590963|147213179|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.574|TWO_SIDED|95.0|0.79|1.568|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.568|0.790|0.574
73832595|NCT04590963|147213180|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.53|TWO_SIDED|95.0|0.818|1.512|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.512|0.818|0.530
73832596|NCT04590963|147213181|SUPERIORITY||Odds Ratio (OR)|0.56||||0.115|TWO_SIDED|95.0|0.274|1.154|||Regression, Logistic|P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.|||1.154|0.274|0.115
73832597|NCT04590963|147213182|SUPERIORITY||Odds Ratio (OR)|0.6||||0.162|TWO_SIDED|95.0|0.297|1.231|||Regression, Logistic|P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for HPV Status, WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.|||1.231|0.297|0.162
73832598|NCT03976375|147213193|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4342|TWO_SIDED|95.0|0.78|1.23||Stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50)|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status|||1.23|0.78|0.4342
73832599|NCT03976375|147213194|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1563|TWO_SIDED|95.0|0.7|1.12||Stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50)|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.12|0.70|0.1563
73832600|NCT03976375|147213195|SUPERIORITY||Difference in Percentage vs Docetaxel|8.4||||0.01818|TWO_SIDED|95.0|0.5|16.3||One-sided p-value for testing. H0: difference in % =0 versus H1: difference in % \> 0.|Miettinen and Nurminen method||Based on Miettinen \& Nurminen method stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50%)|||16.3|0.5|0.01818
73832601|NCT03976375|147213196|SUPERIORITY||Difference in Percentage vs Lenvatinib|10.2||||0.06009|TWO_SIDED|95.0|-3.1|19.9||One-sided p-value for testing. H0: difference in % =0 versus H1: difference in % \> 0.|Miettinen & Nurminen method|||||19.9|-3.1|0.06009
73832602|NCT03976375|147213200|OTHER||Difference in least squares means|-1.36||||0.4998|TWO_SIDED|95.0|-5.32|2.6|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||2.60|-5.32|0.4998
73832603|NCT03976375|147213201|OTHER||Difference in Least Squares Mean|-3.86||||0.1531|TWO_SIDED|95.0|-9.16|1.44|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||1.44|-9.16|0.1531
73832604|NCT03976375|147213202|OTHER||Difference in Least Squares Means|2.48||||0.3084|TWO_SIDED|95.0|-2.31|7.27|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, timing of anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||7.27|-2.31|0.3084
73832605|NCT03976375|147213203|OTHER||Difference in Least Squares Means|-8.04||||0.0058|TWO_SIDED|95.0|-13.73|-2.35|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||-2.35|-13.73|0.0058
73832606|NCT03976375|147213204|OTHER||Difference in Least Squares Means|2.89||||0.1681|TWO_SIDED|95.0|-1.23|7.01|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||7.01|-1.23|0.1681
73832607|NCT03976375|147213205|OTHER||Hazard Ratio (HR)|0.91||||0.6145|TWO_SIDED|95.0|0.63|1.31||stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.31|0.63|0.6145
73832608|NCT03976375|147213206|OTHER||Hazard Ratio (HR)|0.61||||0.0398|TWO_SIDED|95.0|0.38|0.98|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||0.98|0.38|0.0398
73832609|NCT03976375|147213207|OTHER||Hazard Ratio (HR)|1.05||||0.8724|TWO_SIDED|95.0|0.59|1.85|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status|||1.85|0.59|0.8724
73832610|NCT03976375|147213208|OTHER||Hazard Ratio (HR)|0.75||||0.1944|TWO_SIDED|95.0|0.49|1.16||Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.16|0.49|0.1944
73832611|NCT03976375|147213209|OTHER||Hazard Ratio (HR)|1.0||||0.9837|TWO_SIDED|95.0|0.71|1.41|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.41|0.71|0.9837
73832612|NCT03976375|147213210|OTHER||Hazard Ratio (HR)|0.84||||0.2903|TWO_SIDED|95.0|0.6|1.16|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.16|0.60|0.2903
73832613|NCT01063114|147213211|OTHER||3-Year Cumulative incidence|26.0|||||TWO_SIDED|95.0|16.0|37.0||||||||37|16|
73832614|NCT01063114|147213211|OTHER||5-Year Cumulative incidence|27.0|||||TWO_SIDED|95.0|17.0|38.0||||||||38|17|
73832615|NCT01063114|147213212|OTHER||3-Year Cumulative incidence|46.0|||||TWO_SIDED|95.0|34.0|57.0||||||||57|34|
73832616|NCT01063114|147213212|OTHER||5-Year Cumulative incidence|67.0|||||TWO_SIDED|95.0|54.0|77.0||||||||77|54|
73832617|NCT01063114|147213213|OTHER||Mean Difference (Net)|-11.0||||0.01024|TWO_SIDED|95.0|-19.2|-2.9|||t-test, 2 sided|Paired t test||||-2.9|-19.2|0.01024
73832618|NCT01063114|147213214|OTHER||3-Year Survival Probability|83.2|||||TWO_SIDED|95.0|75.8|91.3||||||||91.3|75.8|
73832619|NCT01063114|147213214|OTHER||5-Year Survival Probability|79.6|||||TWO_SIDED|95.0|71.7|88.5||||||||88.5|71.7|
73832620|NCT03409367|147213272|EQUIVALENCE|The risk ratio is equal to 1.|Risk Ratio (RR)|0.84||||0.019|TWO_SIDED|95.0|0.73|0.97|||Regression, log-binomial||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.|The null hypothesis is that the cumulative incidence of atopic dermatitis does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio is equal to 1.||0.97|0.73|0.019
73832621|NCT03409367|147213273|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.76||||0.002|TWO_SIDED|95.0|0.65|0.9|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of parent-reported AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.90|0.65|0.002
73832622|NCT03409367|147213274|EQUIVALENCE|Risk ratio is equal to 1.|Risk Ratio (RR)|0.86||||0.323|TWO_SIDED|95.0|0.65|1.15||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.|Regression, log-binomial|||The null hypothesis is that the cumulative incidence of AD by modified UK Working Party criteria does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.15|0.65|0.323
73832623|NCT03409367|147213275|EQUIVALENCE|Risk ratio is equal to 1.|Risk Ratio (RR)|0.83||||0.044|TWO_SIDED|95.0|0.7|0.99|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of AD by CEQ does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.99|0.70|0.044
73832624|NCT03409367|147213276|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.68||||0.0004|TWO_SIDED|95.0|0.55|0.84|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of AD with prescription or OTC therapies in the health record does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.84|0.55|0.0004
73832625|NCT03409367|147213277|EQUIVALENCE|The odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD, as operationalized here by the type of recommended treatment.|Odds Ratio (OR)|0.7||||0.004|TWO_SIDED|95.0|0.55|0.89||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations of 199 missing outcomes.|Regression, proportional odds|||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms.||0.89|0.55|0.004
73832626|NCT03409367|147213278|EQUIVALENCE|Odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD, as operationalized here by the type of treatment.|Odds Ratio (OR)|0.72||||0.013|TWO_SIDED|95.0|0.56|0.93|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms.||0.93|0.56|0.013
73832627|NCT03409367|147213279|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.92||||0.509|TWO_SIDED|95.0|0.73|1.17|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of skin infections in the health record does not differ between the Daily Emollient and Natural Skin arms.||1.17|0.73|0.509
73832628|NCT03409367|147213280|EQUIVALENCE|The risk ratio is equal to 1.|Risk Ratio (RR)|1.05||||0.9|TWO_SIDED|95.0|0.5|2.18|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of asthma in the health record does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||2.18|0.50|0.900
73832629|NCT03409367|147213281|EQUIVALENCE|An ordinal OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.47||||0.064|TWO_SIDED|95.0|0.98|2.21|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|The daily emollient is in the numerator and the natural skin is in the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.21|0.98|0.064
73832630|NCT03409367|147213282|EQUIVALENCE|An ordinal OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.62||||0.007|TWO_SIDED|95.0|1.14|2.3|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|Daily emollient in the numerator and natural skin in the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.30|1.14|0.007
73832631|NCT03409367|147213283|EQUIVALENCE|The ordinal odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.45||||0.07|TWO_SIDED|95.0|0.97|2.18|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|Daily moisturizer is the numerator and natural skin is the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.18|0.97|0.070
73832632|NCT03409367|147213284|EQUIVALENCE|Odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.36||||0.085|TWO_SIDED|95.0|0.96|1.91|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.||1.91|0.96|0.085
73832633|NCT03409367|147213285|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.75||||0.079|TWO_SIDED|95.0|0.55|1.03|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of immediate food allergy reactions does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.03|0.55|0.079
73832634|NCT03409367|147213286|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.87||||0.669|TWO_SIDED|95.0|0.45|1.66|||Regression, log-binomial|||The null hypothesis is that the cumulative incidence of food allergies does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.66|0.45|0.669
73832635|NCT03409367|147213287|EQUIVALENCE|Risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.|Risk Ratio (RR)|0.77||||0.013|TWO_SIDED|95.0|0.62|0.95|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.||0.95|0.62|0.013
73832636|NCT03409367|147213288|EQUIVALENCE|Risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.|Risk Ratio (RR)|0.8||||0.009|TWO_SIDED|95.0|0.67|0.94|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.||0.94|0.67|0.009
73832637|NCT03409367|147213289|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.77||||0.012|TWO_SIDED|95.0|0.63|0.94|||Regression, log-binomial|Adjusted for primary care site. Adjusted for multiple imputations of 121 missing outcomes.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.94|0.63|0.012
73832638|NCT03409367|147213290|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.9||||0.303|TWO_SIDED|95.0|0.73|1.1|||Regression, log-binomial|Adjusted for primary care site. Adjusted for multiple imputations of 78 missing outcomes.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.10|0.73|0.303
73832639|NCT01913353|147213317|NON_INFERIORITY|The non-inferiority margin to show that Group 1 (after 2 doses of MVA-BN) is non-inferior to Group 2 (after 1 dose of ACAM2000) in terms of PRNT GMTs at the respective peak visit (Week 6 in Group 1 / Week 4 in Group 2) was predefined as '1/2 (i.e. 0.5)' for the GMT ratio (Group 1 / Group 2).|GMT Ratio (Group 1 / Group 2)|1.935|||||TWO_SIDED|95.0|1.562|2.397||||||||2.397|1.562|
73832640|NCT01913353|147213318|SUPERIORITY|Predefined threshold of clinical relevance for the area attenuation ratio (AAR): 40%|Area attenuation ratio (AAR)|97.9|||||TWO_SIDED|95.0|96.6|98.3|||||The AAR, i.e. the reduction in MLA \[1 - MLA ratio (Group 1/Group 2)\] after scarification was to be significantly above 40%. The MLA ratio and the corresponding 95% CI were based on the Hodges-Lehmann estimate of the shift for log-transformed MLAs.|||98.3|96.6|
73832641|NCT01260948|147213347|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.72|||||TWO_SIDED|90.0|94.13|103.53|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.53|94.13|
73832642|NCT01260948|147213348|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.81|||||TWO_SIDED|90.0|91.3|98.47|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.47|91.30|
73832643|NCT02811159|147213401|OTHER|||||||0.1797|||||||Chi-Square Test|||||||0.1797
73832644|NCT02811159|147213402|OTHER|||||||0.125|||||||Wilcoxon Signed-Rank Test|||||||0.1250
73832645|NCT02811159|147213403|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
73832646|NCT02811159|147213404|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
73832647|NCT02811159|147213405|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
73832648|NCT02811159|147213406|OTHER|||||||1|||||||Wilcoxon Signed-Rank Test|||||||1.0000
73832649|NCT02811159|147213407|OTHER|||||||0.875|||||||Wilcoxon Signed-Rank Test|||||||0.8750
73832650|NCT02811159|147213408|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
73832651|NCT02811159|147213409|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
73832652|NCT02811159|147213410|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
73832653|NCT02811159|147213411|OTHER|||||||0.0645|||||||Wilcoxon Signed-Rank Test|||||||0.0645
73832654|NCT04603066|147213413|SUPERIORITY||Mean Difference (Final Values)|0.0204257||||0.8651|TWO_SIDED|95.0|-0.2624635|0.2216122|||t-test, 2 sided|||||0.2216122|-0.2624635|0.8651
73832655|NCT04603066|147213414|SUPERIORITY||Mean Difference (Net)|0.01727052||||0.056|TWO_SIDED|95.0|-0.0005895|0.03513063|||t-test, 2 sided|||||0.03513063|-0.0005895|0.056
73832656|NCT03459846|147213460|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.789|TWO_SIDED|95.0|0.641|1.387|||Regression, Cox|||||1.387|0.641|0.789
73832657|NCT03459846|147213461|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.728|TWO_SIDED|95.0|0.719|1.606|||Regression, Cox|||||1.606|0.719|0.728
73832658|NCT03459846|147213462|SUPERIORITY||Odds Ratio (OR)|1.76||||0.142|TWO_SIDED|95.0|0.821|3.778|||Regression, Logistic|||||3.778|0.821|0.142
73832659|NCT02141113|147213472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|||||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These changed scores show the total change in ADHD symptoms over the course of the trial. Higher values indiicate improved functioning at the end of the trial compared to the beginning.||||.779
73832660|NCT02141113|147213473|SUPERIORITY|||||||0.834|||||||ANOVA|||||||.834
73832661|NCT02141113|147213474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.705|TWO_SIDED||||||ANOVA|||||||.705
73832662|NCT02141113|147213475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322|TWO_SIDED||||||ANOVA|||||||.322
73832663|NCT02141113|147213476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED||||||ANOVA|||||||.043
73832664|NCT02141113|147213477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212|TWO_SIDED||||||ANOVA|||||||.212
73832665|NCT03279458|147213507|OTHER|least square regression analysis|correlation coefficient (R)|0.94|||<|0.05|TWO_SIDED|95.0|0.88|0.97|||Regression, Linear|||||0.97|0.88|<0.05
73832666|NCT06717399|147213521|OTHER|The number of participants (n=15) was calculated using an effect size of 0.89. This effect size was based on a randomized clinical trial utilizing a structured mindfulness meditation program on moderate sleep disturbances in older adults (Black et al. 2015). A power of 0.8 and a significance level of 0.05 was utilized to calculate the sample size, a minimum of 12 participants is required to demonstrate significance in this study. To account for 20% attrition total participants needed is 15.||||||0.00058|||||||t-test, 2 sided|||"Null Hypothesis:~● There will not be a change in sleep quality after participation in eight mindfulness meditation sessions as measured by the Pittsburgh Sleep Quality Index."||||0.00058
73832667|NCT06717399|147213522|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
73832668|NCT04253626|147213524|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||< 0.001
73832669|NCT04253626|147213528|OTHER|||||||0.88||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.88
73832670|NCT04253626|147213529|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|The a priori threshold for statistical significance was \< 0.05.||Between-group analysis of change at week 4||||0.27
73832671|NCT04253626|147213530|OTHER|||||||0.72||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.72
73832672|NCT04253626|147213531|OTHER|||||||0.009||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.009
73832673|NCT05763875|147213534|SUPERIORITY||LS Mean Difference|-35.37|||<|0.0001|TWO_SIDED|95.0|-40.88|-29.86|||ANCOVA|||Treatment Policy Estimand||-29.86|-40.88|<0.0001
73832674|NCT05763875|147213534|SUPERIORITY||LS Mean Difference|-47.91|||<|0.0001|TWO_SIDED|95.0|-53.62|-42.2|||ANCOVA|||Treatment Policy Estimand||-42.20|-53.62|<0.0001
73832675|NCT05763875|147213534|SUPERIORITY||LS Mean Difference|-37.44|||<|0.0001|TWO_SIDED|95.0|-42.63|-32.26|||ANCOVA|||Monotherapy Estimand||-32.26|-42.63|<0.0001
73832676|NCT05763875|147213534|SUPERIORITY||LS Mean Difference|-50.9|||<|0.0001|TWO_SIDED|95.0|-56.51|-45.28|||ANCOVA|||Monotherapy Estimand||-45.28|-56.51|<0.0001
73832677|NCT05763875|147213535|SUPERIORITY||LS Mean Difference|-47.37|||<|0.0001|TWO_SIDED|95.0|-53.91|-40.72|||ANCOVA|||Treatment Policy Estimand||-40.72|-53.91|<0.0001
73832678|NCT05763875|147213535|SUPERIORITY||LS Mean Difference|-63.57|||<|0.0001|TWO_SIDED|95.0|-70.28|-56.87|||ANCOVA|||Treatment Policy Estimand||-56.87|-70.28|<0.0001
73832679|NCT05763875|147213535|SUPERIORITY||LS Mean Difference|-50.05|||<|0.0001|TWO_SIDED|95.0|-56.16|-43.94|||ANCOVA|||Monotherapy Estimand||-43.94|-56.16|<0.0001
73832680|NCT05763875|147213535|SUPERIORITY||LS Mean Difference|-67.51|||<|0.0001|TWO_SIDED|95.0|-74.09|-60.92|||ANCOVA|||Monotherapy Estimand||-60.92|-74.09|<0.0001
73832681|NCT05763875|147213536|SUPERIORITY||LS Mean Difference|-73.16|||<|0.0001|TWO_SIDED|95.0|-81.76|-64.56|||ANCOVA|||Treatment Policy Estimand||-64.56|-81.76|<0.0001
73832682|NCT05763875|147213536|SUPERIORITY||LS Mean Difference|-74.94|||<|0.0001|TWO_SIDED|95.0|-84.51|-65.37|||ANCOVA|||Treatment Policy Estimand||-65.37|-84.51|<0.0001
73832683|NCT05763875|147213536|SUPERIORITY||LS Mean Difference|-76.87|||<|0.0001|TWO_SIDED|95.0|-85.12|-68.62|||ANCOVA|||Monotherapy Estimand||-68.62|-85.12|<0.0001
73832684|NCT05763875|147213536|SUPERIORITY||LS Mean Difference|-79.47|||<|0.0001|TWO_SIDED|95.0|-88.77|-70.17|||ANCOVA|||Monotherapy Estimand||-70.17|-88.77|<0.0001
73832685|NCT05763875|147213537|SUPERIORITY||LS Mean Difference|-30.48|||<|0.0001|TWO_SIDED|95.0|-34.98|-25.98|||ANCOVA|||Treatment Policy Estimand||-25.98|-34.98|<0.0001
73832686|NCT05763875|147213537|SUPERIORITY||LS Mean Difference|-42.32|||<|0.0001|TWO_SIDED|95.0|-47.83|-36.82|||ANCOVA|||Treatment Policy Estimand||-36.82|-47.83|<0.0001
73832687|NCT05763875|147213537|SUPERIORITY||LS Mean Difference|-31.98|||<|0.0001|TWO_SIDED|95.0|-36.07|-27.89|||ANCOVA|||Monotherapy Estimand||-27.89|-36.07|<0.0001
73832688|NCT05763875|147213537|SUPERIORITY||LS Mean Difference|-44.86|||<|0.0001|TWO_SIDED|95.0|-50.28|-39.44|||ANCOVA|||Monotherapy Estimand||-39.44|-50.28|<0.0001
73832689|NCT05763875|147213538|SUPERIORITY||LS Mean Difference|-24.84|||<|0.0001|TWO_SIDED|95.0|-30.32|-19.36|||ANCOVA|||Treatment Policy Estimand||-19.36|-30.32|<0.0001
73832690|NCT05763875|147213538|SUPERIORITY||LS Mean Difference|-33.85|||<|0.0001|TWO_SIDED|95.0|-41.27|-26.44|||ANCOVA|||Treatment Policy Estimand||-26.44|-41.27|<0.0001
73832691|NCT05763875|147213538|SUPERIORITY||LS Mean Difference|-26.58|||<|0.0001|TWO_SIDED|95.0|-32.07|-21.09|||ANCOVA|||Monotherapy Estimand||-21.09|-32.07|<0.0001
73832692|NCT05763875|147213538|SUPERIORITY||LS Mean Difference|-36.06|||<|0.0001|TWO_SIDED|95.0|-43.46|-28.67|||ANCOVA|||Monotherapy Estimand||-28.67|-43.46|<0.0001
73832693|NCT05763875|147213539|SUPERIORITY||LS Mean Difference|-28.98|||<|0.0001|TWO_SIDED|95.0|-33.3|-24.65|||ANCOVA|||Treatment Policy Estimand||-24.65|-33.30|<0.0001
73832694|NCT05763875|147213539|SUPERIORITY||LS Mean Difference|-36.66|||<|0.0001|TWO_SIDED|95.0|-41.1|-32.22|||ANCOVA|||Treatment Policy Estimand||-32.22|-41.10|<0.0001
73832695|NCT05763875|147213539|SUPERIORITY||LS Mean Difference|-30.16|||<|0.0001|TWO_SIDED|95.0|-34.08|-26.23|||ANCOVA|||Monotherapy Estimand||-26.23|-34.08|<0.0001
73832696|NCT05763875|147213539|SUPERIORITY||LS Mean Difference|-38.78|||<|0.0001|TWO_SIDED|95.0|-43.12|-34.43|||ANCOVA|||Monotherapy Estimand||-34.43|-43.12|<0.0001
73832697|NCT05763875|147213540|SUPERIORITY||LS Mean Difference|-30.24|||<|0.0001|TWO_SIDED|95.0|-36.92|-23.57|||ANCOVA|||Treatment Policy Estimand||-23.57|-36.92|<0.0001
73832698|NCT05763875|147213540|SUPERIORITY||LS Mean Difference|-35.15|||<|0.0001|TWO_SIDED|95.0|-41.18|-29.12|||ANCOVA|||Treatment Policy Estimand||-29.12|-41.18|<0.0001
73832699|NCT05763875|147213540|SUPERIORITY||LS Mean Difference|-32.34|||<|0.0001|TWO_SIDED|95.0|-39.1|-25.59|||ANCOVA|||Monotherapy Estimand||-25.59|-39.10|<0.0001
73832700|NCT05763875|147213540|SUPERIORITY||LS Mean Difference|-37.38|||<|0.0001|TWO_SIDED|95.0|-43.44|-31.31|||ANCOVA|||Monotherapy Estimand||-31.31|-43.44|<0.0001
73832701|NCT05763875|147213541|SUPERIORITY||Ratio of Geometric Mean|0.757||||0.0002|TWO_SIDED|95.0|0.65|0.882|||ANCOVA|||Treatment Policy Estimand||0.882|0.650|0.0002
73832702|NCT05763875|147213541|SUPERIORITY||Ratio of Geometric Mean|0.748||||0.001|TWO_SIDED|95.0|0.622|0.898|||ANCOVA|||Treatment Policy Estimand||0.898|0.622|0.0010
73832703|NCT05763875|147213541|SUPERIORITY||Ratio of Geometric Mean|0.753|||<|0.0001|TWO_SIDED|95.0|0.652|0.871|||ANCOVA|||Monotherapy Estimand||0.871|0.652|<0.0001
73832704|NCT05763875|147213541|SUPERIORITY||Ratio of Geometric Mean|0.746||||0.0008|TWO_SIDED|95.0|0.622|0.893|||ANCOVA|||Monotherapy Estimand||0.893|0.622|0.0008
73832705|NCT00217737|147213543|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.63|1.11|||||Hazard ratio: Arm B/Arm A|||1.11|0.63|
73832706|NCT02266576|147213553|OTHER|||||||0.04||||||The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.|Regression, Linear|||Baseline vs month 6||||0.04
73832707|NCT02266576|147213553|OTHER|||||||0.02|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12||||0.02
73832708|NCT02266576|147213554|OTHER|||||||0.004|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 6 in physical component score||||0.004
73832709|NCT02266576|147213554|OTHER|||||||0.01|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12 in physical component score||||0.01
73832710|NCT01147458|147213640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.374||0.067|TWO_SIDED|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.04|0.08|0.067
73832711|NCT01147458|147213640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.369||0.701|TWO_SIDED|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.28|-0.67|0.701
73832712|NCT01147458|147213641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.374||0.067|TWO_SIDED|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.04|0.08|0.067
73832713|NCT01147458|147213641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.369||0.701|TWO_SIDED|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.28|-0.67|0.701
73832714|NCT01147458|147213642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.172|||TWO_SIDED|80.0|-0.15|0.29|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.29|-0.15|
73832715|NCT01147458|147213642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|80.0|-0.09|0.35|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.35|-0.09|
73832716|NCT01147458|147213643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.26|STANDARD_ERROR_OF_MEAN|1.239|||TWO_SIDED|80.0|-0.34|2.85|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||2.85|-0.34|
73832717|NCT01147458|147213643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|1.252|||TWO_SIDED|80.0|-1.95|1.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.28|-1.95|
73832718|NCT01147458|147213644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.06|STANDARD_ERROR_OF_MEAN|1.699|||TWO_SIDED|80.0|-0.13|4.25|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||4.25|-0.13|
73832719|NCT01147458|147213644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|80.0|-2.53|1.88|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.88|-2.53|
73832720|NCT01147458|147213645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|0.624|||TWO_SIDED|80.0|-0.03|1.58|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.58|-0.03|
73832721|NCT01147458|147213645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|80.0|-0.97|0.65|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.65|-0.97|
73832722|NCT01147458|147213646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|80.0|-0.18|0.2|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.20|-0.18|
73832723|NCT01147458|147213646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.147|||TWO_SIDED|80.0|-0.07|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.07|
73832724|NCT01147458|147213647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|80.0|-0.12|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.12|
73832725|NCT01147458|147213647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|80.0|-0.11|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.11|
73832726|NCT02555878|147213654|SUPERIORITY||Hazard Ratio (HR)|0.66|||=|0.101|TWO_SIDED|95.0|0.4|1.09|||Log Rank|||Statistical analysis for primary efficacy composite endpoint.||1.09|0.40|= 0.101
73832727|NCT02555878|147213654|SUPERIORITY||Hazard Ratio (HR)|1.12|||=|0.814|TWO_SIDED|95.0|0.43|2.91|||Log Rank|||Statistical analysis for Symptomatic lower extremity proximal DVT.||2.91|0.43|= 0.814
73832728|NCT02555878|147213654|SUPERIORITY||Hazard Ratio (HR)|0.4|||=|0.26|TWO_SIDED|95.0|0.08|2.07|||Log Rank|||Statistical analysis for symptomatic lower extremity distal DVT.||2.07|0.08|= 0.260
73832729|NCT02555878|147213654|SUPERIORITY||Hazard Ratio (HR)|0.67|||=|0.538|TWO_SIDED|95.0|0.19|2.39|||Log Rank|||Statistical analysis for symptomatic upper extremity DVT.||2.39|0.19|= 0.538
73832730|NCT02555878|147213654|SUPERIORITY||Hazard Ratio (HR)|1.02|||=|0.977|TWO_SIDED|95.0|0.29|3.52|||Log Rank|||Statistical analysis for symptomatic non-fatal PE.||3.52|0.29|= 0.977
73832731|NCT02555878|147213654|SUPERIORITY||Hazard Ratio (HR)|0.35|||=|0.063|TWO_SIDED|95.0|0.11|1.11|||Log Rank|||Statistical analysis for asymptomatic lower extremity proximal DVT.||1.11|0.11|= 0.063
73832732|NCT02555878|147213654|SUPERIORITY||Hazard Ratio (HR)|0.59|||=|0.301|TWO_SIDED|95.0|0.21|1.62|||Log Rank|||Statistical analysis for incidental PE.||1.62|0.21|= 0.301
73832733|NCT02555878|147213654|SUPERIORITY||Hazard Ratio (HR)|0.33|||=|0.314|TWO_SIDED|95.0|0.03|3.18|||Log Rank|||Statistical analysis for VTE-related death.||3.18|0.03|= 0.314
73832734|NCT02555878|147213655|SUPERIORITY||Hazard Ratio (HR)|1.96|||=|0.265|TWO_SIDED|95.0|0.59|6.49|||Log Rank|||||6.49|0.59|= 0.265
73832735|NCT00768053|147213685|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||F test for H0: ICC = 0|F test|||Intraclass correlation coefficient (ICC)||||0.000
73832736|NCT00768053|147213685|SUPERIORITY_OR_OTHER||standard error of measurement|0.65|||||TWO_SIDED|95.0|0.57|0.75||||||Standardized response mean: standard error of measurement||0.75|0.57|
73832737|NCT00768053|147213687|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 4||||<0.001
73832738|NCT00768053|147213688|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 12||||<0.001
73832739|NCT00768053|147213689|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Time-normalized average||||<0.001
73832740|NCT00768053|147213690|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 4||||<0.001
73832741|NCT00768053|147213691|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 12||||<0.001
73832742|NCT00768053|147213692|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Time-normalized average||||<0.001
73832743|NCT00768053|147213693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value||||<0.001
73832744|NCT00768053|147213693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value||||<0.001
73832745|NCT00768053|147213693|SUPERIORITY_OR_OTHER|||||||0.837|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value||||0.837
73832746|NCT00768053|147213693|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value||||0.035
73832747|NCT00768053|147213693|SUPERIORITY_OR_OTHER|||||||0.351|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value||||0.351
73832748|NCT00768053|147213693|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value||||0.025
73832749|NCT00768053|147213693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value||||<0.001
73832750|NCT00768053|147213694|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value||||<0.001
73832751|NCT00768053|147213694|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value||||0.052
73832752|NCT00768053|147213694|SUPERIORITY_OR_OTHER|||||||0.895|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value||||0.895
73832753|NCT00768053|147213694|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value||||0.153
73832754|NCT00768053|147213694|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value||||0.029
73832755|NCT00768053|147213694|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value||||0.043
73832756|NCT00768053|147213694|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value||||<0.001
73832757|NCT01164475|147213711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.395|TWO_SIDED|95.0|0.44|9.17|||Regression, Logistic|||The comparison was done using the logistic regression model, adjusted for country and baseline PB CD34+ cell count.||9.17|0.44|0.395
73832758|NCT03244189|147213724|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.77|1.2||||||||1.20|0.77|
73832759|NCT03244189|147213725|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.72|1.37||||||||1.37|0.72|
73832760|NCT03244189|147213726|OTHER||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0|0.91|2.29||||||||2.29|0.91|
73832761|NCT04950686|147213742|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.08||0.983|TWO_SIDED||||||Mixed Models Analysis|||||||0.983
73832762|NCT04950686|147213742|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.465|TWO_SIDED||||||Mixed Models Analysis|||||||0.465
73832763|NCT04950686|147213743|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.579|TWO_SIDED||||||Mixed Models Analysis|||||||0.579
73832764|NCT04950686|147213743|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Median Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.12||0.536|TWO_SIDED||||||Mixed Models Analysis|||||||0.536
73832765|NCT04950686|147213744|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.745|TWO_SIDED||||||Mixed Models Analysis|||||||0.745
73832766|NCT04950686|147213744|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.14||0.972|TWO_SIDED||||||Mixed Models Analysis|||||||0.972
73832767|NCT04950686|147213745|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.12||||0.682|TWO_SIDED|95.0|0.24|5.25|||Mixed Models Analysis|||||5.25|0.24|0.682
73832768|NCT04950686|147213745|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.15||||0.63|TWO_SIDED|95.0|0.28|4.69|||Mixed Models Analysis|||||4.69|0.28|0.630
73832769|NCT04950686|147213746|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.26||||0.418|TWO_SIDED|95.0|0.12|12.82|||Mixed Models Analysis|||||12.82|0.12|0.418
73832770|NCT04950686|147213746|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.47||||0.194|TWO_SIDED|95.0|0.13|17.29|||Mixed Models Analysis|||||17.29|0.13|0.194
73832771|NCT04950686|147213747|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.91||||0.731|TWO_SIDED|95.0|0.1|8.07|||Mixed Models Analysis|||||8.07|0.10|0.731
73832772|NCT04950686|147213747|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08||||0.786|TWO_SIDED|95.0|0.16|7.34|||Mixed Models Analysis|||||7.34|0.16|0.786
73832773|NCT04950686|147213748|SUPERIORITY|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.11||||0.71|TWO_SIDED|95.0|0.16|7.49|||Mixed Models Analysis|||||7.49|0.16|0.710
73832774|NCT04950686|147213748|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.16||||0.61|TWO_SIDED|95.0|0.16|8.73|||Mixed Models Analysis|||||8.73|0.16|0.610
73832775|NCT04950686|147213749|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.37||||0.27|TWO_SIDED|95.0|0.09|20.33|||Mixed Models Analysis|||||20.33|.09|0.270
73832776|NCT04950686|147213749|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.25||||0.465|TWO_SIDED|95.0|0.08|18.57|||Mixed Models Analysis|||||18.57|0.08|0.465
73832777|NCT04950686|147213750|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.91||||0.702|TWO_SIDED|95.0|0.07|11.95|||Mixed Models Analysis|||||11.95|0.07|0.702
73832778|NCT04950686|147213750|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.21||||0.538|TWO_SIDED|95.0|0.19|7.56|||Mixed Models Analysis|||||7.56|0.19|0.538
73832779|NCT04950686|147213751|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.084|TWO_SIDED||||||Mixed Models Analysis|||||||0.084
73832780|NCT04950686|147213751|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.501|TWO_SIDED||||||Mixed Models Analysis|||||||0.501
73832781|NCT04950686|147213752|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.614|TWO_SIDED||||||Mixed Models Analysis|||||||0.614
73832782|NCT04950686|147213752|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.854|TWO_SIDED||||||Mixed Models Analysis|||||||0.854
73832783|NCT04950686|147213753|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.499|TWO_SIDED||||||Mixed Models Analysis|||||||0.499
73832784|NCT04950686|147213753|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.623|TWO_SIDED||||||Mixed Models Analysis|||||||0.623
73832785|NCT04950686|147213754|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.84||||0.618|TWO_SIDED|95.0|0.14|5.15|||Mixed Models Analysis|||||5.15|0.14|0.618
73832786|NCT04950686|147213754|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.19||||0.626|TWO_SIDED|95.0|0.1|14.13|||Mixed Models Analysis|||||14.13|0.10|0.626
73832787|NCT04950686|147213755|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.47||||0.232|TWO_SIDED|95.0|0.23|9.18|||Mixed Models Analysis|||||9.18|0.23|.232
73832788|NCT04950686|147213755|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08||||0.811|TWO_SIDED|95.0|0.22|5.38|||Mixed Models Analysis|||||5.38|0.22|0.811
73832789|NCT04950686|147213756|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.26||||0.427|TWO_SIDED|95.0|0.16|9.94|||Mixed Models Analysis|||||9.94|0.16|0.427
73832790|NCT04950686|147213756|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.39||||0.337|TWO_SIDED|95.0|0.25|7.68|||Mixed Models Analysis|||||7.68|0.25|0.337
73832791|NCT04950686|147213757|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.11||0.419|TWO_SIDED||||||Mixed Models Analysis|||||||0.419
73832792|NCT04950686|147213757|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.808|TWO_SIDED||||||Mixed Models Analysis|||||||0.808
73832793|NCT04950686|147213758|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.12||0.616|TWO_SIDED||||||Mixed Models Analysis|||||||0.616
73832794|NCT04950686|147213758|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.12||0.486|TWO_SIDED||||||Mixed Models Analysis|||||||0.486
73832795|NCT04950686|147213759|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.638|TWO_SIDED||||||Mixed Models Analysis|||||||0.638
73832796|NCT04950686|147213759|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.226|TWO_SIDED||||||Mixed Models Analysis|||||||0.226
73832797|NCT04950686|147213760|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.14||0.63|TWO_SIDED||||||Mixed Models Analysis|||||||0.630
73832798|NCT04950686|147213760|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.880
73832799|NCT04950686|147213761|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.569|TWO_SIDED||||||Mixed Models Analysis|||||||0.569
73832800|NCT04950686|147213761|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.12||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.980
73832801|NCT04950686|147213762|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.466|TWO_SIDED||||||Mixed Models Analysis|||||||0.466
73832802|NCT04950686|147213762|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.13||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.990
73832803|NCT04950686|147213763|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.14||0.989|TWO_SIDED||||||Mixed Models Analysis|||||||0.989
73832804|NCT04950686|147213763|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.678|TWO_SIDED||||||Mixed Models Analysis|||||||0.678
73832805|NCT04950686|147213764|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.075|TWO_SIDED||||||Mixed Models Analysis|||||||0.075
73832806|NCT04950686|147213764|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.15||0.024|TWO_SIDED||||||Mixed Models Analysis|||||||0.024
73832807|NCT04950686|147213765|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.16||0.301|TWO_SIDED||||||Mixed Models Analysis|||||||0.301
73832808|NCT04950686|147213765|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.17||0.702|TWO_SIDED||||||Mixed Models Analysis|||||||0.702
73832809|NCT04950686|147213766|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.76||||0.352|TWO_SIDED|95.0|0.1|6.13|||Mixed Models Analysis|||||6.13|0.10|0.352
73832810|NCT04950686|147213766|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.82||||0.445|TWO_SIDED|95.0|0.11|6.16|||Mixed Models Analysis|||||6.16|0.11|0.445
73832811|NCT04950686|147213767|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.55||||0.039|TWO_SIDED|95.0|0.12|2.6|||Mixed Models Analysis|||||2.60|0.12|0.039
73832812|NCT04950686|147213767|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.59||||0.073|TWO_SIDED|95.0|0.17|2.12|||Mixed Models Analysis|||||2.12|0.17|0.073
73832813|NCT04950686|147213768|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.62||||0.11|TWO_SIDED|95.0|0.13|2.93|||Mixed Models Analysis|||||2.93|0.13|0.110
73832814|NCT04950686|147213768|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.65||||0.174|TWO_SIDED|95.0|0.11|3.78|||Mixed Models Analysis|||||3.78|0.11|0.174
73832815|NCT04950686|147213769|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.31||0.208|TWO_SIDED||||||Mixed Models Analysis|||||||0.208
73832816|NCT04950686|147213769|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.35||0.302|TWO_SIDED||||||Mixed Models Analysis|||||||0.302
73832817|NCT04950686|147213770|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.35||0.483|TWO_SIDED||||||Mixed Models Analysis|||||||0.483
73832818|NCT04950686|147213770|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.3||0.933|TWO_SIDED||||||Mixed Models Analysis|||||||0.933
73832819|NCT04950686|147213771|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.32||0.877|TWO_SIDED||||||Mixed Models Analysis|||||||0.877
73832820|NCT04950686|147213771|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.32||0.418|TWO_SIDED||||||Mixed Models Analysis|||||||0.418
73832821|NCT04950686|147213772|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|2.23||||0.22|TWO_SIDED|95.0|0.05|98.76|||Mixed Models Analysis|||||98.76|0.05|0.220
73832822|NCT04950686|147213772|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.1|11.3||||||||11.30|0.10|
73832823|NCT04950686|147213773|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.48||||0.506|TWO_SIDED|95.0|0.03|63.29|||Mixed Models Analysis|||||63.29|0.03|0.506
73832824|NCT04950686|147213773|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.04|36.32||||||||36.32|0.04|
73832825|NCT04950686|147213774|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.09||||0.877|TWO_SIDED|95.0|0.04|28.37|||Mixed Models Analysis|||||28.37|0.04|0.877
73832826|NCT04950686|147213774|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.02|26.92||||||||26.92|0.02|
73832827|NCT04950686|147213775|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.04||0.005|TWO_SIDED||||||Mixed Models Analysis|||||||0.005
73832828|NCT04950686|147213775|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.05||1e-05|TWO_SIDED||||||Mixed Models Analysis|||||||0.00001
73832829|NCT04950686|147213776|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.314|TWO_SIDED||||||Mixed Models Analysis|||||||0.314
73832830|NCT04950686|147213776|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.176|TWO_SIDED||||||Mixed Models Analysis|||||||0.176
73832831|NCT04950686|147213777|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.009|TWO_SIDED||||||Mixed Models Analysis|||||||0.009
73832832|NCT04950686|147213777|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.008|TWO_SIDED||||||Mixed Models Analysis|||||||0.008
73832833|NCT04950686|147213778|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.132|TWO_SIDED||||||Mixed Models Analysis|||||||0.132
73832834|NCT04950686|147213778|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.008|TWO_SIDED||||||Mixed Models Analysis|||||||0.008
73832835|NCT04950686|147213779|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.05||0.941|TWO_SIDED||||||Mixed Models Analysis|||||||0.941
73832836|NCT04950686|147213779|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.569|TWO_SIDED||||||Mixed Models Analysis|||||||0.569
73832837|NCT04950686|147213780|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.354|TWO_SIDED||||||Mixed Models Analysis|||||||0.354
73832838|NCT04950686|147213780|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.038|TWO_SIDED||||||Mixed Models Analysis|||||||0.038
73832839|NCT04950686|147213781|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.501|TWO_SIDED||||||Mixed Models Analysis|||||||0.501
73832840|NCT04950686|147213781|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.385|TWO_SIDED||||||Mixed Models Analysis|||||||0.385
73832841|NCT04950686|147213782|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.095|TWO_SIDED||||||Mixed Models Analysis|||||||0.095
73832842|NCT04950686|147213782|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.349|TWO_SIDED||||||Mixed Models Analysis|||||||0.349
73832843|NCT04950686|147213783|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.846|TWO_SIDED||||||Mixed Models Analysis|||||||0.846
73832844|NCT04950686|147213783|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.103|TWO_SIDED||||||Mixed Models Analysis|||||||0.103
73832845|NCT04950686|147213784|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.864|TWO_SIDED||||||Mixed Models Analysis|||||||0.864
73832846|NCT04950686|147213784|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.054|TWO_SIDED||||||Mixed Models Analysis|||||||0.054
73832847|NCT04950686|147213785|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.05||0.168|TWO_SIDED||||||Mixed Models Analysis|||||||0.168
73832848|NCT04950686|147213785|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.063|TWO_SIDED||||||Mixed Models Analysis|||||||0.063
73832849|NCT04950686|147213786|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.819|TWO_SIDED||||||Mixed Models Analysis|||||||0.819
73832850|NCT04950686|147213786|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.775|TWO_SIDED||||||Mixed Models Analysis|||||||0.775
73832851|NCT04950686|147213787|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.034|TWO_SIDED||||||Mixed Models Analysis|||||||0.034
73832852|NCT04950686|147213787|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.579|TWO_SIDED||||||Mixed Models Analysis|||||||0.579
73832853|NCT04950686|147213788|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.485|TWO_SIDED||||||Mixed Models Analysis|||||||0.485
73832854|NCT04950686|147213788|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.911|TWO_SIDED||||||Mixed Models Analysis|||||||0.911
73832855|NCT04950686|147213789|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.583|TWO_SIDED||||||Mixed Models Analysis|||||||0.583
73832856|NCT04950686|147213789|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.971|TWO_SIDED||||||Mixed Models Analysis|||||||0.971
73832857|NCT04950686|147213790|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.602|TWO_SIDED||||||Mixed Models Analysis|||||||0.602
73832858|NCT04950686|147213790|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.04||0.948|TWO_SIDED||||||Mixed Models Analysis|||||||0.948
73832859|NCT04950686|147213791|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.763|TWO_SIDED||||||Mixed Models Analysis|||||||0.763
73832860|NCT04950686|147213791|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.578|TWO_SIDED||||||Mixed Models Analysis|||||||0.578
73832861|NCT04950686|147213792|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.863|TWO_SIDED||||||Mixed Models Analysis|||||||0.863
73832862|NCT04950686|147213792|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.538|TWO_SIDED||||||Mixed Models Analysis|||||||0.538
73832863|NCT04950686|147213793|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|1.41||0.662|TWO_SIDED||||||Mixed Models Analysis|||||||0.662
73832864|NCT04950686|147213793|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|1.81||0.406|TWO_SIDED||||||Mixed Models Analysis|||||||0.406
73832865|NCT04950686|147213794|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|1.64||0.105|TWO_SIDED||||||Mixed Models Analysis|||||||0.105
73832866|NCT04950686|147213794|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-1.33|STANDARD_ERROR_OF_MEAN|1.91||0.487|TWO_SIDED||||||Mixed Models Analysis|||||||0.487
73832867|NCT04950686|147213795|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|1.68||0.171|TWO_SIDED||||||Mixed Models Analysis|||||||0.171
73832868|NCT04950686|147213795|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.06|STANDARD_ERROR_OF_MEAN|1.9||0.278|TWO_SIDED||||||Mixed Models Analysis|||||||0.278
73832869|NCT04950686|147213796|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.283|TWO_SIDED||||||Mixed Models Analysis|||||||0.283
73832870|NCT04950686|147213796|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.824|TWO_SIDED||||||Mixed Models Analysis|||||||0.824
73832871|NCT04950686|147213797|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.965|TWO_SIDED||||||Mixed Models Analysis|||||||0.965
73832872|NCT04950686|147213797|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.902|TWO_SIDED||||||Mixed Models Analysis|||||||0.902
73832873|NCT04950686|147213798|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.074|TWO_SIDED||||||Mixed Models Analysis|||||||0.074
73832874|NCT04950686|147213798|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.828|TWO_SIDED||||||Mixed Models Analysis|||||||0.828
73832875|NCT04950686|147213799|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.25||0.336|TWO_SIDED||||||Mixed Models Analysis|||||||0.336
73832876|NCT04950686|147213799|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.28||0.902|TWO_SIDED||||||Mixed Models Analysis|||||||0.902
73832877|NCT04950686|147213800|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.24||0.629|TWO_SIDED||||||Mixed Models Analysis|||||||0.629
73832878|NCT04950686|147213800|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.29||0.318|TWO_SIDED||||||Mixed Models Analysis|||||||0.318
73832879|NCT04950686|147213801|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.24||0.863|TWO_SIDED||||||Mixed Models Analysis|||||||0.863
73832880|NCT04950686|147213801|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.299|TWO_SIDED||||||Mixed Models Analysis|||||||0.299
73832881|NCT04950686|147213802|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.010
73832882|NCT04950686|147213802|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.119|TWO_SIDED||||||Mixed Models Analysis|||||||0.119
73832883|NCT04950686|147213803|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.161|TWO_SIDED||||||Mixed Models Analysis|||||||0.161
73832884|NCT04950686|147213803|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.087|TWO_SIDED||||||Mixed Models Analysis|||||||0.087
73832885|NCT04950686|147213804|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.810
73832886|NCT04950686|147213804|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.901|TWO_SIDED||||||Mixed Models Analysis|||||||0.901
73832887|NCT04950686|147213805|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.145|TWO_SIDED||||||Mixed Models Analysis|||||||0.145
73832888|NCT04950686|147213805|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.096|TWO_SIDED||||||Mixed Models Analysis|||||||0.096
73832889|NCT04950686|147213806|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.272|TWO_SIDED||||||Mixed Models Analysis|||||||0.272
73832890|NCT04950686|147213806|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.689|TWO_SIDED||||||Mixed Models Analysis|||||||0.689
73832891|NCT04950686|147213807|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.08||0.824|TWO_SIDED||||||Mixed Models Analysis|||||||0.824
73832892|NCT04950686|147213807|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.271|TWO_SIDED||||||Mixed Models Analysis|||||||0.271
73832893|NCT04950686|147213808|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.391|TWO_SIDED||||||Mixed Models Analysis|||||||0.391
73832894|NCT04950686|147213808|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.952|TWO_SIDED||||||Mixed Models Analysis|||||||0.952
73832895|NCT04950686|147213809|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.04||0.925|TWO_SIDED||||||Mixed Models Analysis|||||||0.925
73832896|NCT04950686|147213809|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.05||0.153|TWO_SIDED||||||Mixed Models Analysis|||||||0.153
73832897|NCT04950686|147213810|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.495|TWO_SIDED||||||Mixed Models Analysis|||||||0.495
73832898|NCT04950686|147213810|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.06||0.229|TWO_SIDED||||||Mixed Models Analysis|||||||0.229
73832899|NCT04950686|147213811|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.753|TWO_SIDED||||||Mixed Models Analysis|||||||0.753
73832900|NCT04950686|147213811|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.350
73832901|NCT04950686|147213812|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.541|TWO_SIDED||||||Mixed Models Analysis|||||||0.541
73832902|NCT04950686|147213812|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.887|TWO_SIDED||||||Mixed Models Analysis|||||||0.887
73832903|NCT04950686|147213813|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.375|TWO_SIDED||||||Mixed Models Analysis|||||||0.375
73832904|NCT04950686|147213813|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.293|TWO_SIDED||||||Mixed Models Analysis|||||||0.293
73832905|NCT04950686|147213814|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.97|STANDARD_ERROR_OF_MEAN|1.89||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
73832906|NCT04950686|147213814|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.08|STANDARD_ERROR_OF_MEAN|2.21||0.163|TWO_SIDED||||||Mixed Models Analysis|||||||0.163
73832907|NCT04950686|147213815|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.09|STANDARD_ERROR_OF_MEAN|1.99||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.011
73832908|NCT04950686|147213815|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.21|STANDARD_ERROR_OF_MEAN|2.27||0.159|TWO_SIDED||||||Mixed Models Analysis|||||||0.159
73832909|NCT04950686|147213816|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.83|STANDARD_ERROR_OF_MEAN|2.06||0.064|TWO_SIDED||||||Mixed Models Analysis|||||||0.064
73832910|NCT04950686|147213816|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.37|STANDARD_ERROR_OF_MEAN|2.27||0.137|TWO_SIDED||||||Mixed Models Analysis|||||||0.137
73832911|NCT04950686|147213817|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.05|STANDARD_ERROR_OF_MEAN|1.52||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
73832912|NCT04950686|147213817|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.25|STANDARD_ERROR_OF_MEAN|1.76||0.065|TWO_SIDED||||||Mixed Models Analysis|||||||0.065
73832913|NCT04950686|147213818|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.67|STANDARD_ERROR_OF_MEAN|1.51||0.015|TWO_SIDED||||||Mixed Models Analysis|||||||0.015
73832914|NCT04950686|147213818|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.56|STANDARD_ERROR_OF_MEAN|1.78||0.152|TWO_SIDED||||||Mixed Models Analysis|||||||0.152
73832915|NCT04950686|147213819|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.78|STANDARD_ERROR_OF_MEAN|1.78||0.034|TWO_SIDED||||||Mixed Models Analysis|||||||0.034
73832916|NCT04950686|147213819|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.13|STANDARD_ERROR_OF_MEAN|1.84||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.090
73832917|NCT04950686|147213820|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.282|TWO_SIDED||||||Mixed Models Analysis|||||||0.282
73832918|NCT04950686|147213820|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.532|TWO_SIDED||||||Mixed Models Analysis|||||||0.532
73832919|NCT04950686|147213821|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.675|TWO_SIDED||||||Mixed Models Analysis|||||||0.675
73832920|NCT04950686|147213821|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.443|TWO_SIDED||||||Mixed Models Analysis|||||||0.443
73832921|NCT04950686|147213822|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.685|TWO_SIDED||||||Mixed Models Analysis|||||||0.685
73832922|NCT04950686|147213822|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.726|TWO_SIDED||||||Mixed Models Analysis|||||||0.726
73832923|NCT04950686|147213823|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.282|TWO_SIDED||||||Mixed Models Analysis|||||||0.282
73832924|NCT04950686|147213823|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.591|TWO_SIDED||||||Mixed Models Analysis|||||||0.591
73832925|NCT04950686|147213824|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.675|TWO_SIDED||||||Mixed Models Analysis|||||||0.675
73832926|NCT04950686|147213824|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.359|TWO_SIDED||||||Mixed Models Analysis|||||||0.359
73832927|NCT04950686|147213825|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.rt-type scale from 1 (strongly disagree) to 4 (strongly agree); higher scores indicate greater self-efficacy to use a dental dam; range = 1-4|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.685|TWO_SIDED||||||Mixed Models Analysis|||||||0.685
73832928|NCT04950686|147213825|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.198|TWO_SIDED||||||Mixed Models Analysis|||||||0.198
73832929|NCT04950686|147213826|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.-type scale from 1 (strongly disagree) to 4 (strongly agree); higher scores indicate greater self-efficacy to use a dental dam; range = 1-4|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.46|TWO_SIDED||||||Mixed Models Analysis|||||||0.460
73832930|NCT04950686|147213826|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.822|TWO_SIDED||||||Mixed Models Analysis|||||||0.822
73832931|NCT04950686|147213827|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.671|TWO_SIDED||||||Mixed Models Analysis|||||||0.671
73832932|NCT04950686|147213827|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.939|TWO_SIDED||||||Mixed Models Analysis|||||||0.939
73832933|NCT04950686|147213828|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.655|TWO_SIDED||||||Mixed Models Analysis|||||||0.655
73832934|NCT04950686|147213828|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.315|TWO_SIDED||||||Mixed Models Analysis|||||||0.315
73832935|NCT04950686|147213829|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.04||0.966|TWO_SIDED||||||Mixed Models Analysis|||||||0.966
73832936|NCT04950686|147213829|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.708|TWO_SIDED||||||Mixed Models Analysis|||||||0.708
73832937|NCT04950686|147213830|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.04||0.887|TWO_SIDED||||||Mixed Models Analysis|||||||0.887
73832938|NCT04950686|147213830|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.077|TWO_SIDED||||||Mixed Models Analysis|||||||0.077
73832939|NCT04950686|147213831|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.217|TWO_SIDED||||||Mixed Models Analysis|||||||0.217
73832940|NCT04950686|147213831|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.879|TWO_SIDED||||||Mixed Models Analysis|||||||0.879
73832941|NCT04950686|147213832|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.866|TWO_SIDED||||||Mixed Models Analysis|||||||0.866
73832942|NCT04950686|147213832|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.695|TWO_SIDED||||||Mixed Models Analysis|||||||0.695
73832943|NCT04950686|147213833|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.06||0.94|TWO_SIDED||||||Mixed Models Analysis|||||||0.940
73832944|NCT04950686|147213833|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.451|TWO_SIDED||||||Mixed Models Analysis|||||||0.451
73832945|NCT04950686|147213834|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.442|TWO_SIDED||||||Mixed Models Analysis|||||||0.442
73832946|NCT04950686|147213834|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.082|TWO_SIDED||||||Mixed Models Analysis|||||||0.082
73832947|NCT04950686|147213835|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED||||||Mixed Models Analysis|||||||0.236
73832948|NCT04950686|147213835|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.674|TWO_SIDED||||||Mixed Models Analysis|||||||0.674
73832949|NCT04950686|147213836|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.135|TWO_SIDED||||||Mixed Models Analysis|||||||0.135
73832950|NCT04950686|147213836|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.500
73832951|NCT04950686|147213837|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.09||0.956|TWO_SIDED||||||Mixed Models Analysis|||||||0.956
73832952|NCT04950686|147213837|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.214|TWO_SIDED||||||Mixed Models Analysis|||||||0.214
73832953|NCT04950686|147213838|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.337|TWO_SIDED||||||Mixed Models Analysis|||||||0.337
73832954|NCT04950686|147213838|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.07||0.957|TWO_SIDED||||||Mixed Models Analysis|||||||0.957
73832955|NCT04950686|147213839|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.086|TWO_SIDED||||||Mixed Models Analysis|||||||0.086
73832956|NCT04950686|147213839|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.515|TWO_SIDED||||||Mixed Models Analysis|||||||0.515
73832957|NCT04950686|147213840|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.597|TWO_SIDED||||||Mixed Models Analysis|||||||0.597
73832958|NCT04950686|147213840|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.551|TWO_SIDED||||||Mixed Models Analysis|||||||0.551
73832959|NCT04950686|147213841|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.634|TWO_SIDED||||||Mixed Models Analysis|||||||0.634
73832960|NCT04950686|147213841|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.308|TWO_SIDED||||||Mixed Models Analysis|||||||0.308
73832961|NCT04950686|147213842|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.415|TWO_SIDED||||||Mixed Models Analysis|||||||0.415
73832962|NCT04950686|147213842|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.721|TWO_SIDED||||||Mixed Models Analysis|||||||0.721
73832963|NCT04950686|147213843|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.261|TWO_SIDED||||||Mixed Models Analysis|||||||0.261
73832964|NCT04950686|147213843|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.369|TWO_SIDED||||||Mixed Models Analysis|||||||0.369
73832965|NCT04950686|147213844|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.124|TWO_SIDED||||||Mixed Models Analysis|||||||0.124
73832966|NCT04950686|147213844|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.794|TWO_SIDED||||||Mixed Models Analysis|||||||0.794
73832967|NCT04950686|147213845|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.011
73832968|NCT04950686|147213845|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED||||||Mixed Models Analysis|||||||0.068
73832969|NCT04950686|147213846|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.585|TWO_SIDED||||||Mixed Models Analysis|||||||0.585
73832970|NCT04950686|147213846|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.338|TWO_SIDED||||||Mixed Models Analysis|||||||0.338
73832971|NCT04950686|147213847|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.259|TWO_SIDED||||||Mixed Models Analysis|||||||0.259
73832972|NCT04950686|147213847|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.05||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.950
73832973|NCT04950686|147213848|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.411|TWO_SIDED||||||Mixed Models Analysis|||||||0.411
73832974|NCT04950686|147213848|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.491|TWO_SIDED||||||Mixed Models Analysis|||||||0.491
73832975|NCT04950686|147213849|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.498|TWO_SIDED||||||Mixed Models Analysis|||||||0.498
73832976|NCT04950686|147213849|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.573|TWO_SIDED||||||Mixed Models Analysis|||||||0.573
73832977|NCT04950686|147213850|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.128|TWO_SIDED||||||Mixed Models Analysis|||||||0.128
73832978|NCT04950686|147213850|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
73832979|NCT04950686|147213851|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.0001|STANDARD_ERROR_OF_MEAN|0.07||0.999|TWO_SIDED||||||Mixed Models Analysis|||||||0.999
73832980|NCT04950686|147213851|EQUIVALENCE|This arm will receive Health Aware for Young Adults in between the pretest and posttest questionnaire. Health Aware for Young Adults is a web-based sexual and relationship health promotion program. The program contains the same health content as Media Aware for Young Adults but without the media literacy education components. The program is self-paced and includes four modules.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.08||0.638|TWO_SIDED||||||Mixed Models Analysis|||||||0.638
73832981|NCT04950686|147213852|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.841|TWO_SIDED||||||Mixed Models Analysis|||||||0.841
73832982|NCT04950686|147213852|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.08||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.270
73832983|NCT04950686|147213853|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.94|TWO_SIDED||||||Mixed Models Analysis|||||||0.940
73832984|NCT04950686|147213853|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.09||0.992|TWO_SIDED||||||Mixed Models Analysis|||||||0.992
73832985|NCT04950686|147213854|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.470
73832986|NCT04950686|147213854|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.130
73832987|NCT04950686|147213855|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.931|TWO_SIDED||||||Mixed Models Analysis|||||||0.931
73832988|NCT04950686|147213855|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.666|TWO_SIDED||||||Mixed Models Analysis|||||||0.666
73832989|NCT04950686|147213856|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.822|TWO_SIDED||||||Mixed Models Analysis|||||||0.822
73832990|NCT04950686|147213856|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.721|TWO_SIDED||||||Mixed Models Analysis|||||||0.721
73832991|NCT04950686|147213857|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.54|TWO_SIDED||||||Mixed Models Analysis|||||||0.540
73832992|NCT04950686|147213857|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.06||0.956|TWO_SIDED||||||Mixed Models Analysis|||||||0.956
73832993|NCT04950686|147213858|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.175|TWO_SIDED||||||Mixed Models Analysis|||||||0.175
73832994|NCT04950686|147213858|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.136|TWO_SIDED||||||Mixed Models Analysis|||||||0.136
73832995|NCT04950686|147213859|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.829|TWO_SIDED||||||Mixed Models Analysis|||||||0.829
73832996|NCT04950686|147213859|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.748|TWO_SIDED||||||Mixed Models Analysis|||||||0.748
73832997|NCT04950686|147213860|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.490
73832998|NCT04950686|147213860|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.13||0.831|TWO_SIDED||||||Mixed Models Analysis|||||||0.831
73832999|NCT04950686|147213861|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.1||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.350
73833000|NCT04950686|147213861|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.235|TWO_SIDED||||||Mixed Models Analysis|||||||0.235
73833001|NCT04950686|147213862|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.682|TWO_SIDED||||||Mixed Models Analysis|||||||0.682
73833002|NCT04950686|147213862|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.373|TWO_SIDED||||||Mixed Models Analysis|||||||0.373
73833003|NCT04950686|147213863|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.25||||0.242|TWO_SIDED|95.0|0.24|6.63|||Mixed Models Analysis|||||6.63|0.24|0.242
73833004|NCT04950686|147213863|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.78||||0.207|TWO_SIDED|95.0|0.11|5.72|||Mixed Models Analysis|||||5.72|0.11|0.207
73833005|NCT04950686|147213864|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.88||||0.576|TWO_SIDED|95.0|0.51|1.52|||Mixed Models Analysis|||||1.52|0.51|0.576
73833006|NCT04950686|147213864|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.97||||0.888|TWO_SIDED|95.0|0.46|2.03|||Mixed Models Analysis|||||2.03|0.46|0.888
73833007|NCT04950686|147213865|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.87||||0.467|TWO_SIDED|95.0|0.22|3.45|||Mixed Models Analysis|||||3.45|0.22|0.467
73833008|NCT04950686|147213865|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.97||||0.888|TWO_SIDED|95.0|0.46|2.03|||Mixed Models Analysis|||||2.03|0.46|0.888
73833009|NCT04950686|147213866|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.07||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
73833010|NCT04950686|147213866|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.432|TWO_SIDED||||||Mixed Models Analysis|||||||0.432
73833011|NCT04950686|147213867|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.031|TWO_SIDED||||||Mixed Models Analysis|||||||0.031
73833012|NCT04950686|147213867|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.794|TWO_SIDED||||||Mixed Models Analysis|||||||0.794
73833013|NCT04950686|147213868|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.277|TWO_SIDED||||||Mixed Models Analysis|||||||0.277
73833014|NCT04950686|147213868|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.115|TWO_SIDED||||||Mixed Models Analysis|||||||0.115
73833015|NCT03421808|147213873|SUPERIORITY|||||||0.6|||||||Chi-squared|||For categorical clinical remission data we performed a chi-square test on the IIT and completer sample using Graph-Pad Prism.||||0.6
73833016|NCT00177671|147213920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.97|STANDARD_DEVIATION|2.09||0.05|TWO_SIDED|95.0|1.0|4.41|||Log Rank|||We followed the intention to treat principle. We used Kaplan-Meier curves to quantify the percentage of participants who were free of depression recurrence over time. Cox proportional hazard models quantified hazard ratios comparing the 2 treatment groups.||4.41|1.00|.05
73896620|NCT01478048|147326613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.0923|TWO_SIDED|95.0|0.49|1.06||Log Rank test was stratified by prior proteasome inhibitor use (Yes versus No), presence of at least 1 FcγRIIIa V allele (Yes versus No) and number of prior lines of therapy (1 versus 2 or 3) at randomization|Log Rank|Adjusted alpha level= 0.30||||1.06|0.49|0.0923
73896621|NCT01478048|147326616|SUPERIORITY_OR_OTHER||Difference using Chan-Zhang method|2.3|||||TWO_SIDED|95.0|-13.2|17.8||||||||17.8|-13.2|
73833017|NCT02293499|147213922|SUPERIORITY||partial eta squared|0.003||||0.043|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.043
73833018|NCT02293499|147213922|SUPERIORITY||partial eta squared|0.21||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
73833019|NCT02293499|147213922|SUPERIORITY||Sobel Statistic|2.4119||||0.0079|TWO_SIDED||||||Sobel|||Mediator analysis of AMI-SEI subscale on quality of life||||.0079
73833020|NCT02293499|147213922|SUPERIORITY||Sobel Statistic|2.1132||||0.0172|TWO_SIDED||||||Sobel|||Mediator analysis of ACQ Total score subscale on quality of life||||.0172
73833021|NCT02293499|147213923|SUPERIORITY||partial eta squared|0.001||||0.295|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||0.295
73833022|NCT02293499|147213923|SUPERIORITY||partial eta squared|0.15||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
73833023|NCT02293499|147213924|SUPERIORITY||partial eta squared|0.002||||0.14|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.140
73833024|NCT02293499|147213924|SUPERIORITY||partial eta squared|0.15||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
73833025|NCT02293499|147213925|SUPERIORITY||partial eta squared|0.001||||0.268|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.268
73833026|NCT02293499|147213925|SUPERIORITY||partial eta squared|0.06||||0.14|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.14
73833027|NCT02293499|147213926|SUPERIORITY||partial eta squared|0.001||||0.238|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.238
73833028|NCT02293499|147213926|SUPERIORITY||partial eta squared|0.03||||0.43|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.43
73833029|NCT02293499|147213926|SUPERIORITY||Slope|-0.203||||0.024|TWO_SIDED||||||Mixed Models Analysis|||||||.024
73833030|NCT02293499|147213927|SUPERIORITY||partial eta squared|0.0||||0.484|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.484
73833031|NCT02293499|147213927|SUPERIORITY||partial eta squared|0.12||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
73896622|NCT00955201|147326619|SUPERIORITY|||||||0.49||||||Tukey's multiple comparisons test|ANOVA|Comparison to baseline values||Evaluated within group across time||||0.49
73896623|NCT00955201|147326619|SUPERIORITY|||||||0.82||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.82
73833032|NCT02293499|147213928|SUPERIORITY||partial eta squared|0.0||||0.648|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.648
73833033|NCT02293499|147213928|SUPERIORITY||partial eta squared|0.07||||0.04|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.04
73833034|NCT02293499|147213929|SUPERIORITY||partial eta squared|0.003||||0.02|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.020
73833035|NCT02293499|147213929|SUPERIORITY||partial eta squared|0.04||||0.23|TWO_SIDED|||||A priori threshold for statistical significance is \<.05|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.23
73833036|NCT02293499|147213930|SUPERIORITY||partial eta squared|0.002||||0.049|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.049
73833037|NCT02293499|147213930|SUPERIORITY||partial eta squared|0.12||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
73833038|NCT02293499|147213930|SUPERIORITY||Slope|-0.294||||0.004|TWO_SIDED||||||Mixed Models Analysis|||||||.004
73833039|NCT02293499|147213930|SUPERIORITY||Sobel Statistic|-2.3505||||0.0093|TWO_SIDED||||||Sobel|||Mediator analysis of AMI-SEI subscale on ACQ total||||.0093
73833040|NCT05370326|147213944|SUPERIORITY||Mean Difference (Net)|0.89||||0.69|TWO_SIDED|95.0|-3.67|5.46|||t-test, 2 sided|||||5.46|-3.67|0.69
73833041|NCT05370326|147213949|SUPERIORITY||Mean Difference (Net)|0.23||||0.67|TWO_SIDED|95.0|-0.89|1.36|||t-test, 2 sided|||||1.36|-0.89|0.67
73833042|NCT05370326|147213950|SUPERIORITY||Mean Difference (Net)|0.59||||0.5|TWO_SIDED|95.0|-1.16|2.34|||t-test, 2 sided|||||2.34|-1.16|0.50
73833043|NCT05370326|147213951|SUPERIORITY||Mean Difference (Net)|0.2||||0.74|TWO_SIDED|95.0|-1.09|1.51|||t-test, 2 sided|||||1.51|-1.09|0.74
73833044|NCT05370326|147213953|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
73833045|NCT05370326|147213954|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
73833046|NCT00884065|147214019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|4.08|>|0.05|TWO_SIDED|95.0|-9.93|6.49|||t-test, 2 sided|||||6.49|-9.93|>0.05
73833047|NCT00884065|147214020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.01||95.0|5.72|17.08|||t-test, 2 sided|||||17.08|5.72|<0.01
73833048|NCT00884065|147214021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.24|STANDARD_ERROR_OF_MEAN|2.59|<|0.01|TWO_SIDED|95.0|2.03|12.45|||t-test, 2 sided|||||12.45|2.03|<0.01
73833049|NCT00884065|147214022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.72|>|0.05|TWO_SIDED|95.0|-1.53|5.37|||t-test, 2 sided|||||5.37|-1.53|>0.05
73833050|NCT00884065|147214023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|2.18|>|0.05|TWO_SIDED|95.0|-3.81|5.01|||t-test, 2 sided|||||5.01|-3.81|>0.05
73833051|NCT00884065|147214024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.08|STANDARD_ERROR_OF_MEAN|1.49|<|0.01|TWO_SIDED|95.0|0.08|6.09|||t-test, 2 sided|||||6.09|0.08|<0.01
73833052|NCT02299167|147214033|OTHER|The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method|Mean (95% CI) of effective dose in 90% (|1.9|||||TWO_SIDED|95.0|1.7|2.1|||||The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method|Descriptive statistics were considered to calculate the mathematic mean (SD) of demographic, surgical, and other postoperative continuous data and to calculate the median (range) of sensory and motor block levels, as well as the degree of patient and surgeon satisfaction||2.1|1.7|
73833053|NCT04615507|147214038|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.00 logMAR for Distance.|Mean estimate|-0.132|STANDARD_ERROR_OF_MEAN|0.0201|||TWO_SIDED|95.0|-0.18|-0.083|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||-0.083|-0.180|
73833054|NCT04615507|147214038|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Intermediate.|Mean estimate|-0.066|STANDARD_ERROR_OF_MEAN|0.0202|||TWO_SIDED|95.0|-0.115|-0.017|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||-0.017|-0.115|
73833055|NCT04615507|147214038|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Near.|Mean estimate|0.072|STANDARD_ERROR_OF_MEAN|0.0217|||TWO_SIDED|95.0|0.022|0.121|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||0.121|0.022|
73896624|NCT00955201|147326619|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.96
73833056|NCT04615507|147214039|SUPERIORITY|The superiority of the Test lens will be concluded if the lower confidence limit of the LSM is above the predefined threshold 32 points.|Least-square mean|59.6|STANDARD_ERROR_OF_MEAN|3.05|||TWO_SIDED|95.0|52.3|66.8|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom||||66.8|52.3|
73833057|NCT04615507|147214039|NON_INFERIORITY|The non-Inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above -5 points.|Least-square mean difference|5.5|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|0.9|10.2|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom|LSM difference was calculated as Test minus Control|||10.2|0.9|
73833058|NCT04937387|147214145|OTHER||Least Squares Mean Difference|0.059|STANDARD_ERROR_OF_MEAN|0.0449|||TWO_SIDED|95.0|-0.03|0.147|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline trough FEV1 value, visit, and interaction terms for baseline trough FEV1-by-visit and treatment-by-visit, covariance structure = unstructured.|0.147|-0.030|
73833059|NCT04937387|147214145|OTHER||Posterior Mean|0.076|||||TWO_SIDED|90.0|0.025|0.115|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis.|||0.115|0.025|
73833060|NCT04937387|147214145|OTHER||Posterior Median|0.079|||||TWO_SIDED|95.0|0.005|0.123|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis.|||0.123|0.005|
73833061|NCT04937387|147214146|OTHER||Least Squares Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.0455|||TWO_SIDED|95.0|-0.094|0.084|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline trough FEV1 value, visit, and interaction terms for baseline trough FEV1-by-visit and treatment-by-visit, covariance structure = unstructured.|0.084|-0.094|
73833062|NCT04937387|147214146|OTHER||Posterior Mean|0.023|||||TWO_SIDED|90.0|-0.071|0.103|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 200/62.5/25 and FF/VI 200/25 estimated in the MMRM analysis.|||0.103|-0.071|
73833063|NCT04937387|147214146|OTHER||Posterior Median|0.023||||||95.0|-0.086|0.11|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 200/62.5/25 and FF/VI 200/25 estimated in the MMRM analysis.|||0.110|-0.086|
73833064|NCT04937387|147214147|OTHER||Least Squares Mean Difference|-0.028|STANDARD_ERROR_OF_MEAN|0.0823|||TWO_SIDED|95.0|-0.19|0.134|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline ACQ-7 total score, visit, and interaction terms for baseline ACQ-7 total score-by-visit and treatment-by-visit, covariance structure = unstructured.|0.134|-0.190|
73833065|NCT04937387|147214147|OTHER||Least Squares Mean Difference|0.112|STANDARD_ERROR_OF_MEAN|0.0832|||TWO_SIDED|95.0|-0.052|0.276|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline ACQ-7 total score, visit, and interaction terms for baseline ACQ-7 total score-by-visit and treatment-by-visit, covariance structure = unstructured.|0.276|-0.052|
73833066|NCT01035788|147214167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|7.24||0.849|TWO_SIDED|95.0|-1.39|13.2|||Mixed Models Analysis|p value was obtained from the contrast of the linear mixed model||We sought to obtain a sample size of 18 per group to provide 80% power to detect a .97 standard deviation difference in mean change in CAPS between MB-CBCT and the CBCT-Communication Skills at treatment end based on a two-tailed t-test at 5% significance. Linear mixed models with repeated measures were performed to address the primary hypotheses that MB-CBCT would result in a greater improvement for Veterans and their partners than CBCT-Communication Skills at the end of treatment.||13.2|-1.39|.849
73833067|NCT01001104|147214169|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at 12 weeks.|Mixed Models Analysis|||||||<.001
73833068|NCT01001104|147214169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
73833069|NCT01001104|147214169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.97|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
73833070|NCT01001104|147214169|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.17|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
73833071|NCT01001104|147214170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage|||||||<0.001
73833072|NCT01001104|147214170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73833073|NCT01001104|147214170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73833074|NCT01001104|147214170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73833075|NCT01001104|147214171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage|||||||<0.001
73833076|NCT01001104|147214171|SUPERIORITY_OR_OTHER|||||||0.358||95.0|||||Fisher Exact|||||||0.358
73833077|NCT01001104|147214171|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Fisher Exact|||||||0.014
73833078|NCT01001104|147214171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73833079|NCT01001104|147214172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
73833080|NCT01001104|147214172|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.2||||0.003||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.003
73833081|NCT01001104|147214172|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-19.54||||0.003||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.003
73833082|NCT01001104|147214172|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-28.48|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
73833083|NCT01001104|147214173|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
73833084|NCT01001104|147214173|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-33.2|||<|0.001||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
73833085|NCT01001104|147214173|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-45.63|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
73833086|NCT01001104|147214173|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-41.49|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
73833087|NCT01001104|147214174|SUPERIORITY_OR_OTHER|||||||0.987||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||0.987
73833088|NCT01001104|147214174|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.26||||0.005||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.005
73833089|NCT01001104|147214174|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.45||||0.311||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.311
73833090|NCT01001104|147214174|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.26||||0.556||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.556
73833091|NCT01001104|147214175|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||This is the p-value from the linear trend test at week 12.|Mixed Models Analysis|||||||0.202
73833092|NCT01001104|147214175|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.91||||0.917||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.917
73833093|NCT01001104|147214175|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.81||||0.264||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.264
73833094|NCT01001104|147214175|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-8.4||||0.346||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.346
73833095|NCT01001104|147214176|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
73833096|NCT01001104|147214176|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.1||||0.036||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.036
73833097|NCT01001104|147214176|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|19.73||||0.002||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.002
73833098|NCT01001104|147214176|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|31.68|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
73833099|NCT01001104|147214178|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||This is the p-value from the Cochran-Armitage trend test (dose-effect).|Cochran-Armitage|||||||0.073
73833100|NCT01001104|147214178|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
73833101|NCT01001104|147214178|SUPERIORITY_OR_OTHER|||||||0.233||95.0|||||Fisher Exact|||||||0.233
73833102|NCT02397837|147214179|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
73833103|NCT02397837|147214180|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
73833104|NCT02397837|147214181|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
73833105|NCT02397837|147214182|OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
73833106|NCT02397837|147214183|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
73833107|NCT02397837|147214184|OTHER|||||||0.98|||||||t-test, 2 sided|||||||0.98
73833108|NCT02397837|147214185|OTHER||||||||||||||||||Tabulation of participants with suicidal acknowledgements over 12-week study|||
73833109|NCT02397837|147214186|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
73833110|NCT02397837|147214187|OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
73833111|NCT02397837|147214188|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
73833112|NCT01149785|147214215|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|316.36|||||TWO_SIDED|90.0|286.17|349.73||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||349.73|286.17|
73833113|NCT01149785|147214216|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|328.31|||||TWO_SIDED|90.0|296.42|363.63||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||363.63|296.42|
73833114|NCT01149785|147214219|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|144.13|||||TWO_SIDED|90.0|126.42|164.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||164.33|126.42|
73833115|NCT01149785|147214222|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|519.65|||||TWO_SIDED|90.0|460.42|586.5||||||Natural log transformed AUClast of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||586.50|460.42|
73896625|NCT00955201|147326619|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.93
73896626|NCT00955201|147326619|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at baseline||||0.63
73896627|NCT00955201|147326619|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wk||||0.31
73896628|NCT00955201|147326619|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at 24-wk||||0.28
73896629|NCT00955201|147326620|SUPERIORITY|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.53
73896630|NCT00955201|147326620|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
73896631|NCT00955201|147326620|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
73896632|NCT00955201|147326620|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.93
73896633|NCT00955201|147326620|SUPERIORITY|||||||0.8|||||||ANOVA|||Comparison across groups at baseline.||||0.80
73896634|NCT00955201|147326620|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at 12-wks||||0.63
73833116|NCT01149785|147214223|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|516.98|||||TWO_SIDED|90.0|457.88|583.72||||||Natural log transformed AUC (0-∞) of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||583.72|457.88|
73833117|NCT01149785|147214225|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|161.42|||||TWO_SIDED|90.0|143.09|182.09||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||182.09|143.09|
73833118|NCT01201863|147214229|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.07816|STANDARD_ERROR_OF_MEAN|1.3315||0.954|TWO_SIDED||||||comparison of slopes|Slopes by group and slope difference||To investigate a difference in change in outcome over time between treatment and control, a trend analysis was used in place of a profile analysis, where both control and treatment arms are described more parsimoniously i.e. by a slope (change in outcome over time) (Fitzmaurice 2011).||||0.9540
73833119|NCT00898807|147214236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93||||0.036|TWO_SIDED|95.0|-1.8|-0.06||P-value was not adjusted for multiple comparisons. All p-values are two-sided and p\<0.05 was the threshold for statistical significance.|Mixed Models Analysis|Mixed effects model w/ random intercept for patient, visit indicator, treatment by visit interactions and adjusted for baseline NBRS-A \& cognition.|Negative numbers favor citalopram group.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the NBRS-A, the study was designed to have 85% power to detect a standardized difference at week 9 of 40% for citalopram compared to placebo at week 9.||-0.06|-1.80|0.036
73833120|NCT00898807|147214237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.007|TWO_SIDED|95.0|1.23|3.69||All p-values are two-sided and p \<0.05 was the threshold for statistical significance. No adjustments were made for multiple comparisons.|Proportional odds|estimated treatment effect from the proportional odds model|Positive numbers favors citalopram.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the CGIC proportional odds analysis, the study was designed to have power greater than 80% to detect a difference of 20% between citalopram and placebo in the proportions of patients who improve (or worsen).||3.69|1.23|0.007
73833121|NCT00817063|147214240|SUPERIORITY||Odds Ratio (OR)|3.78|||<|0.001|TWO_SIDED|95.0|2.55|5.62|||Chi-squared, Corrected|||||5.62|2.55|<0.001
73833122|NCT00817063|147214240|SUPERIORITY||Difference in Percentage|24.8|||<|0.001|TWO_SIDED|95.0|18.0|31.7|||Chi-squared, Corrected|||||31.7|18.0|<0.001
73833123|NCT00817063|147214241|SUPERIORITY||Mean Difference (Net)|-24.13|||<|0.001|TWO_SIDED|95.0|-30.4|-17.85|||Kruskal-Wallis|||||-17.85|-30.40|<0.001
73833124|NCT00817063|147214242|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.001|TWO_SIDED|95.0|2.71|6.07|||Chi-squared, Corrected|||||6.07|2.71|<0.001
73833125|NCT00817063|147214242|SUPERIORITY||Difference in Percentage|25.5|||<|0.001|TWO_SIDED|95.0|18.7|32.3|||Chi-squared, Corrected|||||32.3|18.7|<0.001
73833126|NCT00817063|147214243|SUPERIORITY||Mean Difference (Net)|-22.36|||<|0.001|TWO_SIDED|95.0|-31.0|-13.73|||Kruskal-Wallis|||||-13.73|-31.00|<0.001
73833127|NCT00817063|147214244|SUPERIORITY|||||||0.047|||||||Log Rank|||||||0.047
73833128|NCT00817063|147214245|SUPERIORITY|||||||0.068|||||||Log Rank|||||||0.068
73833129|NCT00817063|147214246|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
73833130|NCT00817063|147214255|SUPERIORITY||Mean Difference (Net)|0.489||||0.179|TWO_SIDED|95.0|-0.226|1.204||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (\<12weeks, \>=12 weeks) as covariates.|ANCOVA|||Lumbar Spine BMD||1.204|-0.226|0.179
73833131|NCT00817063|147214255|SUPERIORITY||Mean Difference (Net)|0.497||||0.089|TWO_SIDED|95.0|-0.077|1.071||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (\<12weeks, \>=12 weeks) as covariates.|ANCOVA|||Femur BMD||1.071|-0.077|0.089
73833132|NCT01496456|147214259|SUPERIORITY_OR_OTHER|||||||0.002|||||||Regression, Logistic|Ordinal logistic regression, controlled for baseline lesion size and for correlation among pairs of teeth using the GEE method.||||||0.002
73833133|NCT01496456|147214260|SUPERIORITY_OR_OTHER|||||||0.045|||||||Regression, Logistic|Ordinal logistic regression, controlled for correlation among pairs of teeth using the GEE method.||||||0.045
73833134|NCT01496456|147214261|SUPERIORITY_OR_OTHER|||||||0.0077|||||||Discreet Time Survival Analysis|Controlled for correlation among tooth pairs (GEE model).||||||0.0077
73833135|NCT04919161|147214262|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due sample size differences and pairwise nature of the data, a Kruskal-Wallis was conducted.||Null hypothesis for this analysis is that there will be no differences between pre-scores and post-scores across the different treatment arms. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
73833136|NCT04919161|147214262|SUPERIORITY||||||=|0.0025||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||=0.0025
73833137|NCT04919161|147214262|SUPERIORITY||||||=|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||=0.0001
73833138|NCT04919161|147214262|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
73833139|NCT04919161|147214262|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison would be that there would be no significant difference between post-scores of the two treatment groups.||||>0.9999
73833140|NCT04919161|147214263|SUPERIORITY|Prior to analysis, the score change or difference between post-test and pre-test were calculated for each participant as: ScoreChange=(PostTest) - (PreTest). These changes in score were then compared.|||||=|0.3045||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|t-test, 2 sided|||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=0.3045
73833141|NCT04919161|147214264|SUPERIORITY|Prior to analysis, the score change or difference between post-test and pre-test were calculated for each participant as: PercentScoreChange = (\[(PostTest)-(PreTest)\]/\[PreTest\]) x 100%|||||=|3152||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Two-Tailed Welch t test|Due to unequal standard deviation, a two-tailed Welch's t test was used.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=3152
73833142|NCT04919161|147214265|SUPERIORITY||||||=|0.9568||||||Prior to analysis, the score change between post assessment and pre-assessment was calculated. The threshold for significance was p\<0.05.|t-test, 2 sided|An unpaired T-test was used. Normality and F-test for Variances were conducted and found to be normal.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=0.9568
73833143|NCT04919161|147214266|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due to the pairwise nature and abnormal distribution of the pre- and post-scores, a Kruskal Wallis test was completed.||Null Hypothesis, there would be no difference between the pre-score and post-score of each treatment group. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
73833144|NCT04919161|147214266|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||<0.0001
73833145|NCT04919161|147214266|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||<0.0001
73833146|NCT04919161|147214266|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
73833147|NCT04919161|147214266|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
73833148|NCT04919161|147214267|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due to missing measurements and the pairwise nature of the pre- and post-scores, a Kruskal Wallis test was completed.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
73833149|NCT04919161|147214267|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||<0.0001
73833150|NCT04919161|147214267|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||<0.0001
73833151|NCT04919161|147214267|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||>0.9999
73833152|NCT04919161|147214267|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||>0.9999
73833153|NCT04919161|147214268|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p\<0.05.|Kruskal-Wallis|Due to the missing measurement and the pairwise nature of the perturbation levels between participants, a Kruskal Wallis test was completed.||Null hypothesis is there are no differences between groups. Prior to hypothesis testing, normality testing was conducted using a Shapiro-Wild test to inform if parametric or non-parametric testing was required.||||<0.0001
73833154|NCT04919161|147214268|SUPERIORITY||||||>|0.9999||||||Reported p-value is adjusted for multiple comparisons. The a priori threshold for statistical significance was established as p\<0.05.|Dunn's Multiple Comparison Test|||Null hypothesis for any comparisons would be that there is no significant mean perturbation level between sessions.|The p-value reported above was the result for 15 comparisons of the recorded perturbation levels in sessions: 1 vs 2, 2 vs 3, 3 vs 4, 3 vs 5, 3 vs 6, 4 vs 5, 4 vs 6, 4 vs 7, 4 vs 8, 5 vs 6, 5 vs 7, 5 vs 8, 6 vs 7, 6 vs 8, and 7 vs 8.|||>0.9999
73833155|NCT04919161|147214268|SUPERIORITY||||||=|0.0629|||||||Dunn's Multiple Comparison Test|||||||=0.0629
73833156|NCT04919161|147214268|SUPERIORITY||||||=|0.0069|||||||Dunn's Multiple Comparison Test|||||||=0.0069
73833157|NCT04919161|147214268|SUPERIORITY||||||=|0.0003|||||||Dunn's Multiple Comparison Test|||||||=0.0003
73833158|NCT04919161|147214268|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
73833159|NCT04919161|147214268|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
73833160|NCT04919161|147214268|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
73833161|NCT04919161|147214268|SUPERIORITY||||||=|0.6497|||||||Dunn's Multiple Comparison Test|||||||=0.6497
73833162|NCT04919161|147214268|SUPERIORITY||||||=|0.0743|||||||Dunn's Multiple Comparison Test|||||||=0.0743
73833163|NCT04919161|147214268|SUPERIORITY||||||=|0.0198|||||||Dunn's Multiple Comparison Test|||||||=0.0198
73833164|NCT04919161|147214268|SUPERIORITY||||||=|0.0017|||||||Dunn's Multiple Comparison Test|||||||=0.0017
73833165|NCT04919161|147214268|SUPERIORITY||||||=|0.0006|||||||Dunn's Multiple Comparison Test|||||||=0.0006
73833166|NCT04919161|147214268|SUPERIORITY||||||=|0.5297|||||||Dunn's Multiple Comparison Test|||||||=0.5297
73833167|NCT04919161|147214268|SUPERIORITY||||||=|0.2595|||||||Dunn's Multiple Comparison Test|||||||=0.2595
73833168|NCT04919161|147214269|OTHER|This is a descriptive analysis.|Odds Ratio (OR)|2.6|||=|0.3898|TWO_SIDED|95.0|0.4671|15.3||Threshold for statistical significance was p\<0.05|Fisher Exact|||Null hypothesis was that there would be no difference in the proportion of males and females between treatment arms.||15.300|0.4671|=0.3898
73833169|NCT02489773|147214270|OTHER|Calculate the pearson correlation within whole subjects (across Group 1 and Group 2)|pearson correlation coefficient|0.6342|||||TWO_SIDED|||||||||||||
73833170|NCT02489773|147214270|OTHER|Diffenrence between Pearson correlations within whole subjects (accross Group 1 and Group 2) and PG, 0.8.|Difference with PG 0.8|-0.1658|||>|0.9999|TWO_SIDED|95.0|-0.2204|-0.1113|||t-test, 2 sided|||||-0.1113|-0.2204|>0.9999
73833171|NCT02489773|147214271|OTHER|The difference in Spearman correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficients|0.249|||<|0.0001|TWO_SIDED|95.0|0.13|0.364|||t-test, 2 sided|||||0.364|0.130|<0.0001
73833172|NCT02489773|147214272|OTHER|The difference in Kendall correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficient|0.181|||<|0.0001|TWO_SIDED|95.0|0.096|0.265|||t-test, 2 sided|||||0.265|0.096|<0.0001
73833173|NCT00712920|147214273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.03||95.0|-1.7|-0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.10|-1.70|0.03
73833174|NCT00712920|147214273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.08||95.0|-1.5|0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.1|-1.5|0.08
73833175|NCT00712920|147214274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6419|STANDARD_DEVIATION|0.3924||0.102||95.0|-1.41|0.13|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.13|-1.41|0.102
73833176|NCT00712920|147214274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7925|STANDARD_DEVIATION|0.3935||0.044||95.0|-1.56|-0.02|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.02|-1.56|0.044
73833177|NCT00712920|147214275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4394|STANDARD_DEVIATION|0.3631||0.226||95.0|-1.15|0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28||0.27|-1.15|0.226
73833178|NCT00712920|147214275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1252|STANDARD_DEVIATION|0.3649||0.002||95.0|-1.84|-0.41|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28||-0.41|-1.84|0.002
73833179|NCT00712920|147214276|SUPERIORITY_OR_OTHER|||||||0.292||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||||||0.292
73833180|NCT00712920|147214276|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||||||0.040
73833181|NCT02493855|147214291|SUPERIORITY|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.311|||||||Wilcoxon Rank Sum Test|||||||0.311
73833182|NCT02493855|147214291|SUPERIORITY|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.561|||||||Wilcoxon Rank Sum Test|||||||0.561
73833183|NCT02111980|147214295|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||t-test, 2 sided|||||||1.0
73833184|NCT00063622|147214310|SUPERIORITY_OR_OTHER|||||||0.001||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.||||0.001
73833185|NCT00063622|147214310|SUPERIORITY_OR_OTHER|||||||0.04||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.||||0.04
73833186|NCT00063622|147214311|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Fisher Exact|||||||0.005
73833187|NCT00063622|147214311|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73833188|NCT00063622|147214312|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||||||0.02
73833189|NCT00063622|147214312|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|||||||0.004
73833190|NCT00063622|147214313|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Fisher Exact|||||||0.01
73833191|NCT00063622|147214313|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Fisher Exact|||||||0.08
73833192|NCT00063622|147214314|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Fisher Exact|||||||0.24
73833193|NCT00063622|147214314|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||||||0.12
73833194|NCT00063622|147214315|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Fisher Exact|||||||0.05
73833195|NCT00063622|147214315|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
73833196|NCT02583269|147214349|OTHER|||||||0.76|||||||ANOVA|||Overall FACT G score p value baseline to week 8||||0.76
73833197|NCT02583269|147214349|OTHER|||||||0.25|||||||ANOVA|||Fact G functional well being p value baseline to week 8||||0.25
73833198|NCT02583269|147214349|OTHER|||||||0.18|||||||ANOVA|||FACT G emotional well being p value baseline to week 8||||0.18
73833199|NCT02583269|147214349|OTHER|||||||0.87|||||||ANOVA|||Fact G physical well being p value baseline to week 8||||0.87
73833200|NCT02583269|147214349|OTHER|||||||0.22|||||||ANOVA|||Fact G social well being p value baseline to week 8||||0.22
73833201|NCT02583269|147214357|OTHER|||||||0.67|||||||ANOVA|||||||0.67
73833202|NCT02583269|147214358|OTHER|||||||0.119|||||||ANOVA|||Baseline v. 4 weeks log IL-8||||0.119
73833203|NCT02583269|147214358|OTHER|||||||0.414|||||||ANOVA|||Baseline v. 8 weeks log IL-8||||0.414
73833204|NCT02583269|147214359|OTHER|||||||0.851|||||||ANOVA|||Baseline v. 4 weeks p value log VEGF||||0.851
73833205|NCT02583269|147214359|OTHER|||||||0.688|||||||ANOVA|||Baseline vs. 8 weeks p value log VEGF||||0.688
73833206|NCT02906618|147214446|OTHER|A mixed-effect analysis of variance model was applied to the log-transformed dose-adjusted AUC(0-∞) of LY3039478 after oral dosing and IV administration of 13C 15N 2H-LY3039478. The model contained a fixed effect for formulation (oral or IV) and a random effect for participant.|Ratio of geometric LS means|0.572|||||TWO_SIDED|90.0|0.532|0.615||||||||0.615|0.532|
73833207|NCT00876395|147214450|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1166|TWO_SIDED|95.0|0.73|1.08|||Log Rank|||||1.08|0.73|0.1166
73833208|NCT00876395|147214451|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0049|TWO_SIDED|95.0|0.48|0.91|||Log Rank|||||0.91|0.48|0.0049
73833209|NCT00876395|147214454|SUPERIORITY|||||||0.7276|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.7276
73833210|NCT00876395|147214455|SUPERIORITY|||||||0.4085|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.4085
73833211|NCT00876395|147214456|SUPERIORITY|||||||0.9573|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.9573
73833212|NCT00876395|147214457|SUPERIORITY|||||||0.6382|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.6382
73833213|NCT03807843|147214468|OTHER||V184 GMFR/Placebo GMFR Ratio|1.6||||0.004|TWO_SIDED|95.0|1.2|2.1|||Mixed Effects Model|||"Day 28 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 28 was derived from the mixed effects model used to determine GMFR."||2.1|1.2|0.004
73833214|NCT03807843|147214468|OTHER||V184 GMFR/Placebo GMFR Ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.5|2.8|||Mixed Effects Model|||"Day 56 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 56 was derived from the mixed effects model used to determine GMFR."||2.8|1.5|<0.001
73833215|NCT03807843|147214468|OTHER||V184 GMFR/Placebo GMFR Ratio|1.3||||0.121|TWO_SIDED|95.0|0.9|1.7|||Mixed Effects Model|||"Day 196 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 196 was derived from the mixed effects model used to determine GMFR."||1.7|0.9|0.121
73833216|NCT01312129|147214471|SUPERIORITY_OR_OTHER||||||=|0.05|TWO_SIDED|||||=0.05 is the actual computed p-value via the ANOVA.|ANOVA|The ANOVA is comparing the % increase in BOLD response above baseline during cue presentation (Alcohol vs. Control) b/w placebo \& Sulfasalazine .||||||=.05
73833217|NCT00924651|147214475|OTHER||Mean Difference (Final Values)|-0.01916|STANDARD_ERROR_OF_MEAN|0.1791||0.9148|TWO_SIDED|95.0|-0.371|0.3327|||ANCOVA|||||0.3327|-0.3710|0.9148
73833218|NCT01991314|147214476|NON_INFERIORITY_OR_EQUIVALENCE|We calculated, on the premise that there is non-inferiority between adolescent and adult groups in the difference in increase of mean haemoglobin levels of 0.35g/dL, with estimated standard deviation 0.7g/dL following treatment, that 45 patients in each group would be required, derived using power 80% power, 1-sided significance level 0.05 and R 0.5 for the covariate; this calculation took into account planned ANCOVA methodology and 20% patients who might be lost to follow up or withdraw.|Mean Difference (Net)|0.08||||0.23|TWO_SIDED|||||To test the hypothesis of non-inferiority with maximal statistical power, ANCOVA (one-tailed P\<0.05) was employed to compare the change in mean haemoglobin levels between adults and adolescents after accounting for necessary covariates|ANCOVA|||||||0.23
73833219|NCT01991314|147214477|SUPERIORITY_OR_OTHER||difference in proportions|3.6|||<|0.05|TWO_SIDED||||||Fisher Exact|Fisher's exact test was used to compare proportions (expressed as percentages) of total number of participants in each group who were iron intolerant||Chi squared test or Fisher's exact test, as appropriate.||||<0.05
73833220|NCT01991314|147214478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0||||0.96|TWO_SIDED||||||t-test, 2 sided|||Unpaired Students t test||||0.96
73833221|NCT01991314|147214479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test||||0.49
73833222|NCT01991314|147214480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test||||0.85
73833223|NCT01991314|147214481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test||||0.69
73833224|NCT01991314|147214482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.9|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test||||<0.0001
73833225|NCT00970944|147214483|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Mixed Models Analysis|||We will have 80% power to detect a one point difference in DRS score between the groups across the four week treatment window. With this sample size, we will be able to detect any unforeseen adverse events that have a prevalence of at least 2.5% in each group with 90% probability. With 92 patients per group we will be able to estimate the rate of adverse events to within ±10%.||||0.045
73896635|NCT00955201|147326620|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 24-wk||||0.31
73896636|NCT00955201|147326621|SUPERIORITY|||||||0.39||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.39
73896637|NCT00955201|147326621|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
73833226|NCT00970944|147214484|SUPERIORITY_OR_OTHER||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.088||0.007||95.0|-0.41|-0.07||The final analysis used a significance level of 0.045.|Mixed Models Analysis|Final analysis adjusted for early v. late enrollment relative to date of injury, baseline CRS-R rating category (MCS vs. VS), and site.||The planned sample size of 184 patients provided 80% power to detect a difference between the AH and placebo in the rate of Disability Rating Scale (DRS) score change of 0.3 points/week (1.22 DRS point mean difference by the end of the 4-week treatment interval). Two blinded interim analyses were conducted at 60 and 120 patients recruited using the O'Brien-Fleming boundary, with alpha levels of 0.0005 and 0.014. The final analysis used an alpha level of 0.045.||-0.07|-0.41|0.007
73833227|NCT01033942|147214490|SUPERIORITY_OR_OTHER|||||||0.6983||||||The p-value is for the difference in treatment (TX) groups overall. The interaction between TX group and study time that tests whether the TX groups differed over time could not be tested due to small no. of subjects that missed visits during study.|Chi-squared|||||||0.6983
73833228|NCT01033942|147214491|SUPERIORITY_OR_OTHER|||||||0.8722|TWO_SIDED||||||Fisher Exact|||||||0.8722
73833229|NCT01033942|147214492|SUPERIORITY_OR_OTHER|||||||0.6921||||||Not all subjects answered every question.|Fisher Exact|||||||0.6921
73833230|NCT01033942|147214493|SUPERIORITY_OR_OTHER|||||||0.4655||||||Not all participants answered every question|Fisher Exact|||||||0.4655
73833231|NCT01033942|147214494|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED|||||Not all participants answered every question|Fisher Exact|||||||0.9999
73833232|NCT01033942|147214495|SUPERIORITY_OR_OTHER|||||||0.2297|TWO_SIDED|||||Not all participants answered every question|Fisher Exact|||||||0.2297
73833233|NCT01033942|147214496|SUPERIORITY_OR_OTHER|||||||0.1886||||||Not all participants answered every question|Fisher Exact|||||||0.1886
73833234|NCT01033942|147214497|SUPERIORITY_OR_OTHER|||||||0.1908|||||||Fisher Exact|||||||0.1908
73833235|NCT01033942|147214498|SUPERIORITY_OR_OTHER|||||||0.224||||||Not all participants answered every question|Fisher Exact|||||||0.2240
73833236|NCT01033942|147214499|SUPERIORITY_OR_OTHER|||||||0.1538||||||Not all participants answered every question|Fisher Exact|||||||0.1538
73833237|NCT01033942|147214500|SUPERIORITY_OR_OTHER|||||||0.2151||||||Not all participants answered every question|Fisher Exact|||||||0.2151
73833238|NCT01033942|147214501|SUPERIORITY_OR_OTHER|||||||0.2809||||||Not all participants answered every question|Fisher Exact|||||||0.2809
73833239|NCT01033942|147214502|SUPERIORITY_OR_OTHER|||||||0.185||||||Not all participants answered every question|Fisher Exact|||||||0.1850
73833240|NCT01033942|147214503|SUPERIORITY_OR_OTHER|||||||0.2366||||||Not all participants answered every question|Fisher Exact|||||||0.2366
73833241|NCT01033942|147214504|SUPERIORITY_OR_OTHER|||||||0.4089||||||Not all subjects answered every question.|Fisher Exact|||||||0.4089
73833242|NCT01033942|147214505|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
73833243|NCT01033942|147214506|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
73833244|NCT01033942|147214507|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
73833245|NCT01033942|147214508|SUPERIORITY_OR_OTHER|||||||0.7007|||||||Fisher Exact|||||||0.7007
73833246|NCT01033942|147214509|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
73833247|NCT01033942|147214510|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
73833248|NCT01033942|147214511|SUPERIORITY_OR_OTHER|||||||0.8934|||||||Chi-squared|||||||0.8934
73833249|NCT01033942|147214512|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
73833250|NCT01033942|147214513|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
73833251|NCT01033942|147214514|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
73833252|NCT01033942|147214515|SUPERIORITY_OR_OTHER|||||||0.4003|||||||Fisher Exact|||||||0.4003
73833253|NCT01033942|147214516|SUPERIORITY_OR_OTHER|||||||0.6462|||||||Fisher Exact|||||||0.6462
73833254|NCT01033942|147214517|SUPERIORITY_OR_OTHER|||||||0.8505|||||||Chi-squared|||||||0.8505
73833255|NCT01033942|147214525|SUPERIORITY_OR_OTHER|||||||0.7434|TWO_SIDED||||||Chi-squared|||||||0.7434
73833256|NCT01033942|147214526|SUPERIORITY_OR_OTHER|||||||0.6153|TWO_SIDED||||||Chi-squared|||||||0.6153
73833257|NCT01033942|147214527|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|||||||0.2000
73833258|NCT01033942|147214528|SUPERIORITY_OR_OTHER|||||||0.5265|TWO_SIDED||||||Chi-squared|||||||0.5265
73833259|NCT01033942|147214529|SUPERIORITY_OR_OTHER|||||||0.2559|TWO_SIDED||||||Chi-squared|||||||0.2559
73833260|NCT01033942|147214530|SUPERIORITY_OR_OTHER|||||||0.3846|TWO_SIDED||||||Chi-squared|||||||0.3846
73833261|NCT01033942|147214531|SUPERIORITY_OR_OTHER|||||||0.5133|TWO_SIDED||||||Chi-squared|||||||0.5133
73833262|NCT01033942|147214532|SUPERIORITY_OR_OTHER|||||||0.1661|TWO_SIDED||||||Chi-squared|||||||0.1661
73833263|NCT01033942|147214533|SUPERIORITY_OR_OTHER|||||||0.0729|TWO_SIDED||||||Chi-squared|||||||0.0729
73833264|NCT01033942|147214534|SUPERIORITY_OR_OTHER|||||||0.1912|TWO_SIDED||||||Chi-squared|||||||0.1912
73833265|NCT01033942|147214535|SUPERIORITY_OR_OTHER|||||||0.2829|TWO_SIDED||||||Chi-squared|||||||0.2829
73833266|NCT01033942|147214536|SUPERIORITY_OR_OTHER|||||||0.2685|TWO_SIDED||||||Chi-squared|||||||0.2685
73833267|NCT01033942|147214537|SUPERIORITY_OR_OTHER|||||||0.2342|TWO_SIDED||||||Chi-squared|||||||0.2342
73833268|NCT01033942|147214538|SUPERIORITY_OR_OTHER|||||||0.7314|TWO_SIDED||||||Fisher Exact|||||||0.7314
73833269|NCT01033942|147214539|SUPERIORITY_OR_OTHER|||||||0.377|||||||Fisher Exact|||||||0.3770
73833270|NCT01033942|147214540|SUPERIORITY_OR_OTHER|||||||0.7004|||||||Fisher Exact|||||||0.7004
73833271|NCT01033942|147214541|SUPERIORITY_OR_OTHER|||||||0.4668|||||||Fisher Exact|||||||0.4668
73833272|NCT01033942|147214542|SUPERIORITY_OR_OTHER|||||||0.7573|||||||Fisher Exact|||||||0.7573
73833273|NCT01033942|147214543|SUPERIORITY_OR_OTHER|||||||0.0356|||||||Fisher Exact|||||||0.0356
73833274|NCT01033942|147214544|SUPERIORITY_OR_OTHER|||||||0.3176|||||||Fisher Exact|||||||0.3176
73833275|NCT01033942|147214545|SUPERIORITY_OR_OTHER|||||||0.1348|||||||Fisher Exact|||||||0.1348
73833276|NCT01033942|147214546|SUPERIORITY_OR_OTHER|||||||0.042|||||||Fisher Exact|||||||0.0420
73833277|NCT01033942|147214547|SUPERIORITY_OR_OTHER|||||||0.4906|||||||Fisher Exact|||||||0.4906
73833278|NCT01033942|147214548|SUPERIORITY_OR_OTHER|||||||0.0544|||||||Fisher Exact|||||||0.0544
73833279|NCT01033942|147214549|SUPERIORITY_OR_OTHER|||||||0.5645|||||||Fisher Exact|||||||0.5645
73833280|NCT01033942|147214550|SUPERIORITY_OR_OTHER|||||||0.7847|||||||Fisher Exact|||||||0.7847
73833281|NCT01033942|147214551|SUPERIORITY_OR_OTHER|||||||0.0288|||||||Fisher Exact|||||||0.0288
73833282|NCT01033942|147214552|SUPERIORITY_OR_OTHER|||||||0.0945|||||||Fisher Exact|||||||0.0945
73833283|NCT01033942|147214553|SUPERIORITY_OR_OTHER|||||||0.3884|||||||Fisher Exact|||||||0.3884
73833284|NCT01033942|147214554|SUPERIORITY_OR_OTHER|||||||0.2235|||||||Fisher Exact|||||||0.2235
73833285|NCT01033942|147214555|SUPERIORITY_OR_OTHER|||||||0.0467|||||||Fisher Exact|||||||0.0467
73833286|NCT01033942|147214556|SUPERIORITY_OR_OTHER|||||||0.6331|||||||Fisher Exact|||||||0.6331
73833287|NCT01033942|147214557|SUPERIORITY_OR_OTHER|||||||0.0948|||||||Fisher Exact|||||||0.0948
73833288|NCT01033942|147214558|SUPERIORITY_OR_OTHER|||||||0.5826|||||||Fisher Exact|||||||0.5826
73833289|NCT01033942|147214559|SUPERIORITY_OR_OTHER|||||||0.0087|||||||Fisher Exact|||||||0.0087
73833290|NCT01033942|147214560|SUPERIORITY_OR_OTHER|||||||0.1934|||||||Fisher Exact|||||||0.1934
73833291|NCT01033942|147214561|SUPERIORITY_OR_OTHER|||||||0.2146|||||||Fisher Exact|||||||0.2146
73833292|NCT01033942|147214562|SUPERIORITY_OR_OTHER|||||||0.5317|||||||Fisher Exact|||||||0.5317
73833293|NCT01033942|147214563|SUPERIORITY_OR_OTHER|||||||0.1733|||||||Fisher Exact|||||||0.1733
73833294|NCT01033942|147214564|SUPERIORITY_OR_OTHER|||||||0.1747|||||||Fisher Exact|||||||0.1747
73833295|NCT01033942|147214565|SUPERIORITY_OR_OTHER|||||||0.1203|||||||Fisher Exact|||||||0.1203
73833296|NCT01033942|147214566|SUPERIORITY_OR_OTHER|||||||0.8243|||||||Fisher Exact|||||||0.8243
73833297|NCT01033942|147214567|SUPERIORITY_OR_OTHER|||||||0.6202|||||||Fisher Exact|||||||0.6202
73833298|NCT01033942|147214568|SUPERIORITY_OR_OTHER|||||||0.8351|||||||Fisher Exact|||||||0.8351
73833299|NCT01033942|147214569|SUPERIORITY_OR_OTHER|||||||0.0484|||||||Fisher Exact|||||||0.0484
73833300|NCT01033942|147214570|SUPERIORITY_OR_OTHER|||||||0.4207|||||||Fisher Exact|||||||0.4207
73833301|NCT01033942|147214571|SUPERIORITY_OR_OTHER|||||||0.2187|||||||Fisher Exact|||||||0.2187
73833302|NCT01033942|147214572|SUPERIORITY_OR_OTHER|||||||0.5369|||||||Fisher Exact|||||||0.5369
73833303|NCT01033942|147214573|SUPERIORITY_OR_OTHER|||||||0.1524|||||||Fisher Exact|||||||0.1524
73833304|NCT01033942|147214574|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||||||0.4700
73833305|NCT01033942|147214575|SUPERIORITY_OR_OTHER|||||||0.4686|||||||Fisher Exact|||||||0.4686
73833306|NCT01033942|147214576|SUPERIORITY_OR_OTHER|||||||0.3791|||||||Fisher Exact|||||||0.3791
73833307|NCT01033942|147214577|SUPERIORITY_OR_OTHER|||||||0.7374|||||||Fisher Exact|||||||0.7374
73833308|NCT01033942|147214578|SUPERIORITY_OR_OTHER|||||||0.9363|||||||Fisher Exact|||||||0.9363
73833309|NCT01033942|147214579|SUPERIORITY_OR_OTHER|||||||0.6267|||||||Fisher Exact|||||||0.6267
73833310|NCT01033942|147214580|SUPERIORITY_OR_OTHER|||||||0.6434|TWO_SIDED||||||Fisher Exact|||||||0.6434
73833311|NCT01033942|147214581|SUPERIORITY_OR_OTHER|||||||0.8582|TWO_SIDED||||||Fisher Exact|||||||0.8582
73833312|NCT01033942|147214582|SUPERIORITY_OR_OTHER|||||||0.5778|TWO_SIDED||||||Fisher Exact|||||||0.5778
73833313|NCT01033942|147214583|SUPERIORITY_OR_OTHER|||||||0.9881|TWO_SIDED||||||Fisher Exact|||||||0.9881
73833314|NCT01033942|147214584|SUPERIORITY_OR_OTHER|||||||0.9771|TWO_SIDED||||||Fisher Exact|||||||0.9771
73833315|NCT01033942|147214585|SUPERIORITY_OR_OTHER|||||||0.2301|TWO_SIDED||||||Fisher Exact|||||||0.2301
73833316|NCT02260986|147214597|SUPERIORITY||difference in percentages|26.3|||<|0.0001|TWO_SIDED|95.0|16.34|36.26||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.||36.26|16.34|<0.0001
73833317|NCT02260986|147214597|SUPERIORITY||difference in percentages|26.8|||<|0.0001|TWO_SIDED|95.0|20.33|33.28||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.||33.28|20.33|<0.0001
73833318|NCT02260986|147214598|SUPERIORITY|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|45.7|||<|0.0001|TWO_SIDED|95.0|35.72|55.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level for both comparisons.||55.66|35.72|<0.0001
73833319|NCT02260986|147214598|SUPERIORITY|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|40.8|||<|0.0001|TWO_SIDED|95.0|33.74|47.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level for both comparisons.||47.81|33.74|<0.0001
73896638|NCT00955201|147326621|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
73896639|NCT00955201|147326621|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
73896640|NCT00955201|147326621|SUPERIORITY|||||||0.7|||||||ANOVA|||Comparison across groups at baseline||||0.70
73896641|NCT00955201|147326621|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at 12-wks||||0.45
73833320|NCT02260986|147214599|SUPERIORITY||difference in percentages|39.1|||<|0.0001|TWO_SIDED|95.0|28.53|49.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||49.65|28.53|<0.0001
73833321|NCT02260986|147214599|SUPERIORITY||difference in percentages|31.1|||<|0.0001|TWO_SIDED|95.0|23.84|38.39||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||38.39|23.84|<0.0001
73833322|NCT02260986|147214600|SUPERIORITY||difference in percentages|37.9|||<|0.0001|TWO_SIDED|95.0|27.56|48.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||48.31|27.56|<0.0001
73833323|NCT02260986|147214600|SUPERIORITY||difference in percentages|34.7|||<|0.0001|TWO_SIDED|95.0|27.31|42.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||42.05|27.31|<0.0001
73833324|NCT02260986|147214601|SUPERIORITY||difference in percentages|23.5|||<|0.0001|TWO_SIDED|95.0|12.72|34.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.||34.19|12.72|<0.0001
73833325|NCT02260986|147214601|SUPERIORITY||difference in percentages|27.5|||<|0.0001|TWO_SIDED|95.0|20.42|34.58||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.||34.58|20.42|<0.0001
73833326|NCT02260986|147214602|SUPERIORITY||difference in percentages|43.6|||<|0.0001|TWO_SIDED|95.0|32.5|54.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.||54.65|32.50|<0.0001
73833327|NCT02260986|147214602|SUPERIORITY||difference in percentages|42.5|||<|0.0001|TWO_SIDED|95.0|34.91|50.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.||50.06|34.91|<0.0001
73833328|NCT02260986|147214603|SUPERIORITY||Least square (LS) mean difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-35.04|-17.43||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-17.43|-35.04|<0.0001
73833329|NCT02260986|147214603|SUPERIORITY||LS mean difference|-26.8|||<|0.0001|TWO_SIDED|95.0|-32.83|-20.73||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-20.73|-32.83|<0.0001
73833330|NCT02260986|147214604|SUPERIORITY||difference in percentages|38.3|||<|0.0001|TWO_SIDED|95.0|26.96|49.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||49.66|26.96|<0.0001
73833331|NCT02260986|147214604|SUPERIORITY||difference in percentages|26.1|||<|0.0001|TWO_SIDED|95.0|18.76|33.45||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||33.45|18.76|<0.0001
73896642|NCT00955201|147326621|SUPERIORITY|||||||0.22|||||||ANOVA|||Comparison across groups at 24-wks||||0.22
73833332|NCT02260986|147214605|SUPERIORITY||difference in percentages|40.1|||<|0.0001|TWO_SIDED|95.0|28.76|51.35||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||51.35|28.76|<0.0001
73833333|NCT02260986|147214605|SUPERIORITY||difference in percentages|27.3|||<|0.0001|TWO_SIDED|95.0|19.81|34.76||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||34.76|19.81|<0.0001
73833334|NCT02260986|147214606|SUPERIORITY||difference in percentages|37.9|||<|0.0001|TWO_SIDED|95.0|27.34|48.4||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.||48.40|27.34|<0.0001
73833335|NCT02260986|147214606|SUPERIORITY||difference in percentages|27.7|||<|0.0001|TWO_SIDED|95.0|20.65|34.7||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.||34.70|20.65|<0.0001
73833336|NCT02260986|147214607|SUPERIORITY||difference in percentages|20.9|||<|0.0001|TWO_SIDED|95.0|10.59|31.15||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.||31.15|10.59|<0.0001
73833337|NCT02260986|147214607|SUPERIORITY||difference in percentages|10.7||||0.0021|TWO_SIDED|95.0|4.15|17.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.||17.31|4.15|0.0021
73833338|NCT02260986|147214608|SUPERIORITY||difference in percentages|9.6||||0.0062|TWO_SIDED|95.0|1.61|17.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.||17.63|1.61|0.0062
73833339|NCT02260986|147214608|SUPERIORITY||difference in percentages|5.5||||0.0344|TWO_SIDED|95.0|0.56|10.51||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.||10.51|0.56|0.0344
73833340|NCT02260986|147214609|SUPERIORITY||LS mean difference|-1.81|||<|0.0001|TWO_SIDED|95.0|-2.297|-1.322||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-1.322|-2.297|<0.0001
73833341|NCT02260986|147214610|SUPERIORITY||LS mean difference|-32.1|||<|0.0001|TWO_SIDED|95.0|-46.37|-17.82||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-17.82|-46.37|<0.0001
73833342|NCT02260986|147214611|SUPERIORITY||LS mean difference|-18.38|||<|0.0001|TWO_SIDED|95.0|-22.583|-14.187||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-14.187|-22.583|<0.0001
73833343|NCT02260986|147214612|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-33.46|-21.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-21.9|-33.46|<0.0001
73833344|NCT02260986|147214613|SUPERIORITY||LS mean difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.31|-3.02||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-3.02|-5.31|<0.0001
73833345|NCT02260986|147214614|SUPERIORITY||LS mean difference|-7.4|||<|0.0001|TWO_SIDED|95.0|-8.85|-5.93||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-5.93|-8.85|<0.0001
73833346|NCT02260986|147214615|SUPERIORITY||LS mean difference|-1.0||||0.1596|TWO_SIDED|95.0|-2.27|0.37||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||0.37|-2.27|0.1596
73833347|NCT01482221|147214706|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|1.695||0.63|TWO_SIDED|95.0|-4.519|2.152||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.152|-4.519|0.630
73833348|NCT01482221|147214706|SUPERIORITY_OR_OTHER||LS mean difference|-1.21|STANDARD_ERROR_OF_MEAN|1.701||0.476|TWO_SIDED|95.0|-4.563|2.134||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.134|-4.563|0.476
73833349|NCT01482221|147214707|SUPERIORITY_OR_OTHER||LS mean difference|-2.05|STANDARD_ERROR_OF_MEAN|1.816||0.63|TWO_SIDED|95.0|-5.628|1.522||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.522|-5.628|0.630
73833350|NCT01482221|147214707|SUPERIORITY_OR_OTHER||LS mean difference|0.88|STANDARD_ERROR_OF_MEAN|1.83||0.63|TWO_SIDED|95.0|-2.72|4.485||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||4.485|-2.720|0.630
73833351|NCT01482221|147214708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07|STANDARD_ERROR_OF_MEAN|0.366||0.852|TWO_SIDED|95.0|0.544|2.089||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.||2.089|0.544|0.852
73833352|NCT01482221|147214708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.37||0.821|TWO_SIDED|95.0|0.552|2.115||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.||2.115|0.552|0.821
73833353|NCT01482221|147214709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.318||0.751|TWO_SIDED|95.0|0.485|1.686|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.686|0.485|0.751
73833354|NCT01482221|147214709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.315||0.555|TWO_SIDED|95.0|0.65|2.233|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.233|0.650|0.555
73833355|NCT01482221|147214710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27|STANDARD_ERROR_OF_MEAN|0.304||0.434|TWO_SIDED|95.0|0.699|2.301|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.301|0.699|0.434
73833356|NCT01482221|147214710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.322||0.286|TWO_SIDED|95.0|0.377|1.334|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.334|0.377|0.286
73833357|NCT01482221|147214711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|STANDARD_ERROR_OF_MEAN|0.382||0.357|TWO_SIDED|95.0|0.672|3.007|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||3.007|0.672|0.357
73833358|NCT01482221|147214711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|STANDARD_ERROR_OF_MEAN|0.387||0.463|TWO_SIDED|95.0|0.622|2.84|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.840|0.622|0.463
73833359|NCT01482221|147214712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.342||0.911|TWO_SIDED|95.0|0.532|2.031|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.031|0.532|0.911
73833360|NCT01482221|147214712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|STANDARD_ERROR_OF_MEAN|0.368||0.509|TWO_SIDED|95.0|0.382|1.613|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.613|0.382|0.509
73833361|NCT01482221|147214713|SUPERIORITY_OR_OTHER||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|1.238||0.889|TWO_SIDED|95.0|-2.609|2.264||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.264|-2.609|0.889
73833362|NCT01482221|147214713|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.264||0.992|TWO_SIDED|95.0|-2.477|2.501||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.501|-2.477|0.992
73833363|NCT01482221|147214713|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|1.301||0.392|TWO_SIDED|95.0|-1.448|3.678||Analysis for change in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.678|-1.448|0.392
73896643|NCT00955201|147326622|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
73896644|NCT00955201|147326622|SUPERIORITY|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.90
73896645|NCT00955201|147326622|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
73896646|NCT00955201|147326622|SUPERIORITY|||||||0.78||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.78
73896647|NCT00955201|147326622|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at baseline||||0.63
73896648|NCT00955201|147326622|SUPERIORITY|||||||0.97|||||||ANOVA|||Comparison across groups at 12-wk||||0.97
73833364|NCT01482221|147214713|SUPERIORITY_OR_OTHER||LS mean difference|1.29|STANDARD_ERROR_OF_MEAN|1.329||0.333|TWO_SIDED|95.0|-1.327|3.908||Analysis for changed in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.908|-1.327|0.333
73833365|NCT01482221|147214714|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.728|TWO_SIDED|95.0|-0.49|0.34||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.34|-0.49|0.728
73833366|NCT01482221|147214714|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.562|TWO_SIDED|95.0|-0.54|0.29||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.29|-0.54|0.562
73833367|NCT01482221|147214714|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.283|TWO_SIDED|95.0|-0.64|0.19||Analysis for change in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.19|-0.64|0.283
73833368|NCT01482221|147214714|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.54|TWO_SIDED|95.0|-0.29|0.55||Analysis for changed in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.55|-0.29|0.540
73833369|NCT01482221|147214715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|STANDARD_ERROR_OF_MEAN|0.302||0.067|TWO_SIDED|95.0|0.962|3.141|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||3.141|0.962|0.067
73833370|NCT01482221|147214715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|STANDARD_ERROR_OF_MEAN|0.297||0.23|TWO_SIDED|95.0|0.798|2.558|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||2.558|0.798|0.230
73833371|NCT01482221|147214716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38|STANDARD_ERROR_OF_MEAN|0.292||0.268|TWO_SIDED|95.0|0.78|2.447|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||2.447|0.780|0.268
73833372|NCT01482221|147214716|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.303||0.909|TWO_SIDED|95.0|0.533|1.75|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||1.750|0.533|0.909
73833373|NCT01482221|147214717|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.505|TWO_SIDED|95.0|-2.29|1.13||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.13|-2.29|0.505
73833374|NCT01482221|147214717|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.88||0.842|TWO_SIDED|95.0|-1.56|1.91||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.91|-1.56|0.842
73833375|NCT01482221|147214717|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.89||0.788|TWO_SIDED|95.0|-1.98|1.51||Analysis for change in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.51|-1.98|0.788
73833376|NCT01482221|147214717|SUPERIORITY_OR_OTHER||LS mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.9||0.133|TWO_SIDED|95.0|-0.42|3.12||Analysis for changed in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.12|-0.42|0.133
73896649|NCT00955201|147326622|SUPERIORITY|||||||0.99|||||||ANOVA|||Comparison across groups at 24-wks||||0.99
73833377|NCT03086343|147214718|NON_INFERIORITY|The non-inferiority of upadacitinib 15 mg versus abatacept was tested using the 95% confidence interval (CI) of treatment difference against a non-inferiority margin of 0.6.|LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.35||The ANCOVA model included treatment as the fixed factor; corresponding baseline value and the stratification factor of prior bDMARD used as covariates.|ANCOVA||Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||-0.35|-0.69|< 0.001
73833378|NCT03086343|147214719|SUPERIORITY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.35||This comparison was a ranked secondary endpoint in the pre-specified multiplicity testing sequence.|ANCOVA|The ANCOVA model included treatment as the fixed factor; corresponding baseline value and the stratification factor of prior bDMARD used as covariates|Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||-0.35|-0.69|< 0.001
73833379|NCT03086343|147214720|SUPERIORITY||Mean Difference|16.8|||<|0.001|TWO_SIDED|95.0|10.4|23.2||This comparison was a ranked secondary endpoint in the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|The stratification factor of prior failed bDMARD was used.|Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||23.2|10.4|< 0.001
73833380|NCT01922011|147214757|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% CI is greater than -15%|Common Difference|-6.1||||0.421|TWO_SIDED|95.0|-19.4|7.4|||Wald||Daptomycin - Comparator|95% confidence interval of the common difference was based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.||7.4|-19.4|0.421
73833381|NCT01922011|147214758|SUPERIORITY_OR_OTHER||Common difference|-7.1||||0.467|TWO_SIDED|95.0|-21.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|||7.9|-21.6|0.467
73833382|NCT01922011|147214759|SUPERIORITY_OR_OTHER||Common difference|-6.2||||0.313|TWO_SIDED|95.0|-17.5|5.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOIV visit||5.0|-17.5|0.313
73833383|NCT01922011|147214759|SUPERIORITY_OR_OTHER||Common difference|-7.9||||0.239|TWO_SIDED|95.0|-19.8|4.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOT visit||4.0|-19.8|0.239
73833384|NCT01922011|147214759|SUPERIORITY_OR_OTHER||Common difference|-6.7||||0.37|TWO_SIDED|95.0|-19.1|5.8|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At TOC visit||5.8|-19.1|0.370
73833385|NCT01922011|147214760|SUPERIORITY_OR_OTHER||Common difference|-10.5||||0.23|TWO_SIDED|95.0|-26.3|5.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen||5.4|-26.3|0.230
73833386|NCT01922011|147214760|SUPERIORITY_OR_OTHER||Common difference|-12.3||||0.164|TWO_SIDED|95.0|-28.5|4.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA||4.4|-28.5|0.164
73833387|NCT01922011|147214760|SUPERIORITY_OR_OTHER||Common difference|-15.5||||0.043|TWO_SIDED|95.0|-31.2|1.1|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA||1.1|-31.2|0.043
73833388|NCT01922011|147214760|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wald|||MRSA||||0.450
73833389|NCT01922011|147214760|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wald|||Other Pathogen||||0.280
73833390|NCT01922011|147214761|SUPERIORITY_OR_OTHER||Common difference|-6.3||||0.272|TWO_SIDED|95.0|-18.2|5.5|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|EOT||5.5|-18.2|0.272
73833391|NCT01922011|147214761|SUPERIORITY_OR_OTHER||Common difference|-4.8||||0.48|TWO_SIDED|95.0|-17.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|TOC||7.9|-17.6|0.480
73833392|NCT01922011|147214762|SUPERIORITY_OR_OTHER||Common difference|-10.1|||||TWO_SIDED|95.0|-24.8|4.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen||4.2|-24.8|
73896650|NCT00955201|147326623|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.94
73833393|NCT01922011|147214762|SUPERIORITY_OR_OTHER||Common difference|-12.2|||||TWO_SIDED|95.0|-27.2|2.8|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA||2.8|-27.2|
73833394|NCT01922011|147214762|SUPERIORITY_OR_OTHER||Common difference|-10.4|||||TWO_SIDED|95.0|-25.4|5.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA||5.2|-25.4|
73833395|NCT02202616|147214796|OTHER||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|0.34|||TWO_SIDED|95.0|0.14|0.21|||Descriptive Statistics with 95% CI|The mean change from baseline along with the 95% confidence interval used to assess the precision of the estimate||||0.21|0.14|
73833396|NCT02202616|147214797|OTHER||Mean Difference (Final Values)|0.14|STANDARD_DEVIATION|0.278|||TWO_SIDED|95.0|0.11|0.17|||Descriptive Statistics with 95% CI|The mean change from baseline along with the 95% confidence interval used to assess the precision of the estimate||||0.17|0.11|
73833397|NCT02202616|147214798|OTHER||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|2.47|||TWO_SIDED|95.0|1.74|2.3|||Standard Descriptive Statistics|The estimated mean change from baseline and corresponding 95% confidence intervals will be displayed for each visit.||Week 4||2.30|1.74|
73833398|NCT02202616|147214798|OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|2.92|||TWO_SIDED|95.0|2.21|2.85|||Standard Descriptive Statistics|The estimated mean change from baseline and corresponding 95% confidence intervals will be displayed for each visit||Week 16||2.85|2.21|
73833399|NCT02202616|147214799|OTHER||Mean Difference (Final Values)|-5.0|STANDARD_DEVIATION|6.25|||TWO_SIDED|95.0|-5.7|-4.3|||standard descriptive statistics|The estimated mean change from baseline to Week 4 along with the 95% confidence interval||Week 4||-4.3|-5.7|
73833400|NCT02202616|147214799|OTHER||Mean Difference (Final Values)|-6.5|STANDARD_DEVIATION|7.03|||TWO_SIDED|95.0|-7.3|-5.7|||standard descriptive statistics|The estimated mean change from baseline to Week 4 along with the 95% confidence interval||Week 16||-5.7|-7.3|
73833401|NCT04502524|147214800|OTHER|||||||0.999|||||||Fisher Exact|||For overall satisfaction, a reliable estimate could not be calculated using a logistic regression model as all the responses were the same in the Vet Flexiquit arm. We calculated the p-value using the Fisher's exact test.||||.999
73833402|NCT04502524|147214801|OTHER||Slope|0.05||||0.852|TWO_SIDED|95.0|-0.46|0.56|||Regression, negative binomial|||||0.56|-0.46|0.852
73833403|NCT04502524|147214802|OTHER||Slope|-0.44||||0.451|TWO_SIDED|95.0|-1.6|0.71|||Regression, negative binomial|||||0.71|-1.60|0.451
73833404|NCT04502524|147214803|OTHER||Slope|-0.73||||0.508|TWO_SIDED|95.0|-1.46|0.003|||Regression, negative binomial|||||0.003|-1.46|0.508
73833405|NCT04502524|147214804|OTHER||Odds Ratio (OR)|0.65||||0.602|TWO_SIDED|95.0|0.13|3.32|||Regression, Logistic|||||3.32|0.13|0.602
73833406|NCT04502524|147214805|OTHER||Odds Ratio (OR)|0.94||||0.941|TWO_SIDED|95.0|0.17|5.29|||Regression, Logistic|||||5.29|0.17|0.941
73833407|NCT04502524|147214806|OTHER||Odds Ratio (OR)|0.61||||0.612|TWO_SIDED|95.0|0.09|4.12|||Regression, Logistic|||||4.12|0.09|0.612
73833408|NCT04502524|147214807|OTHER||Slope|0.56||||0.504|TWO_SIDED|95.0|-1.13|2.26|||Regression, Linear|||||2.26|-1.13|0.504
73833409|NCT04502524|147214808|OTHER||Slope|0.11||||0.67|TWO_SIDED|95.0|-0.4|0.61|||Regression, Linear|||||0.61|-0.40|0.670
73833410|NCT04327271|147214811|NON_INFERIORITY|Non-inferiority margin of -0.25% set as lower bound of 95% CI for the maximum mean difference between the proportion of cumulative AEs between control and 2wT arms to conclude that 2wT is non-inferior. This margin was set considering the average AE rate of 0.5% from routine SSA MC programs at scale, and assuming that 2wT increases AE ascertainment to 2.0%, similar to 1.9% of Zimbabwe RCT and the widely-accepted standard 2% AE rate.|Mean Difference (Final Values)|1.2|||||ONE_SIDED|95.0|-0.09|||||||With 10% loss to follow-up (LTFU), a sample size of 1104 men provides at least 80% power to rule out a decrease in AE ascertainment of more than 0.25% based on the lower bound of the one-sided 95% CI. The one tailed alpha was set 0.05.|||-.09|
73833411|NCT04327271|147214812|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.001|TWO_SIDED|95.0|1.03|1.21|||Fisher Exact|||The mean number of in-person clinic visit, excluding non-study visits, were compared between the two arms using a t-test. The proportion of potential AEs was calculated as number of potential AE responses divided by the total number of daily responses (no AE and potential AE). A superiority test was performed on the safety outcomes using a two-sided 95% confidence interval and p-value using Fisher's exact test.||1.21|1.03|0.001
73833412|NCT01479530|147214827|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0228|TWO_SIDED|95.0|-0.92|-0.07|||ANCOVA|||||-0.07|-0.92|0.0228
73833413|NCT01479530|147214828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.22|||ANCOVA|||||-0.22|-0.61|<0.0001
73833414|NCT01479530|147214829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.37||0.0075|TWO_SIDED|95.0|-1.75|-0.27|||ANCOVA|||||-0.27|-1.75|0.0075
73833415|NCT01479530|147214830|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.74||0.0317|TWO_SIDED|95.0|-3.05|-0.14|||ANCOVA|||||-0.14|-3.05|0.0317
73833416|NCT00303628|147214831|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876|TWO_SIDED|||||Stratified log rank test. The above P value was for one-sided test|Log Rank|||||||0.876
73833417|NCT00303628|147214832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299|TWO_SIDED|||||two-sided stratified log rank test p value|Log Rank|||||||0.299
73833418|NCT01018979|147214847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.||||0.023
73833419|NCT01018979|147214847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.||||0.038
73833420|NCT03010501|147214858|SUPERIORITY||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis|||||||< 0.0001
73833421|NCT03010501|147214859|SUPERIORITY|||||||0.1||||||According to predefined comparisons, intake by weight in the 80% intervention was compared to the 100% intervention.|Mixed Models Analysis|||||||0.10
73833422|NCT03010501|147214859|SUPERIORITY|||||||0.15||||||According to predefined comparisons, intake by weight in the 120% intervention was compared to the 100% intervention.|Mixed Models Analysis|||||||0.15
73833423|NCT03010501|147214860|SUPERIORITY||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis|||||||< 0.0001
73833424|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6346|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.6346
73833425|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2757|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.2757
73833426|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1321|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.1321
73833427|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5543|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.5543
73833428|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||0.3940
73833429|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7891|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.7891
73833430|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.||||0.4829
73833431|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4526|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.4526
73833432|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.||||0.2485
73833433|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6252|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.6252
73833434|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4003|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.||||0.4003
73833435|NCT00544882|147214895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8841|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.8841
73833436|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8892|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.8892
73833437|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7678|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.7678
73833438|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5782|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.5782
73833439|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8083|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.8083
73833440|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||1.0000
73833441|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4122|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.4122
73833442|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.||||0.6675
73833443|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8445|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.8445
73833444|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3772|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.||||0.3772
73833445|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1918|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.1918
73833446|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.||||0.6675
73833447|NCT00544882|147214897|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9226|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.9226
73833448|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0979|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.0979
73833449|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0629|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.0629
73833450|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.8464
73833451|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6316|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.6316
73833452|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||0.3000
73833453|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0955|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.0955
73833454|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1523|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 25 time point.||||0.1523
73833455|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2809|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.2809
73833456|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 28 time point.||||0.8829
73833457|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9262|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.9262
73833458|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7811|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 -Day 4 time point.||||0.7811
73833459|NCT00544882|147214898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3703|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.3703
73833460|NCT03043573|147214904|SUPERIORITY||Mean Difference (Final Values)|-0.7011||||0.9644|TWO_SIDED|95.0|-31.8605|30.4583|||t-test, 2 sided|||Baseline||30.4583|-31.8605|0.9644
73833461|NCT03043573|147214904|SUPERIORITY||Mean Difference (Final Values)|2.4595||||0.888|TWO_SIDED|95.0|-32.3472|37.2661|||t-test, 2 sided|||Week 12||37.2661|-32.3472|0.8880
73833462|NCT03043573|147214904|SUPERIORITY||Mean Difference (Final Values)|-0.5119||||0.9773|TWO_SIDED|95.0|-36.5024|35.4785|||t-test, 2 sided|||Week 24||35.4785|-36.5024|0.9773
73833463|NCT03043573|147214904|SUPERIORITY||Mean Difference (Final Values)|15.6667||||0.6173|TWO_SIDED|95.0|-47.0598|78.3931|||t-test, 1 sided|||Week 52||78.3931|-47.0598|0.6173
73833464|NCT03043573|147214905|SUPERIORITY||Mean Difference (Final Values)|1.1302||||0.5454|TWO_SIDED|95.0|-2.5767|4.8371|||t-test, 2 sided|||Baseline||4.8371|-2.5767|0.5454
73833465|NCT03043573|147214905|SUPERIORITY||Mean Difference (Final Values)|2.9618||||0.1212|TWO_SIDED|95.0|-0.8038|6.7275|||t-test, 2 sided|||Week 6||6.7275|-0.8038|0.1212
73833466|NCT03043573|147214905|SUPERIORITY||Mean Difference (Final Values)|1.095||||0.571|TWO_SIDED|95.0|-2.7476|4.9377|||t-test, 2 sided|||Week 12||4.9377|-2.7476|0.5710
73833467|NCT03043573|147214905|SUPERIORITY||Mean Difference (Final Values)|-1.5524||||0.4377|TWO_SIDED|95.0|-5.5256|2.4209|||t-test, 2 sided|||Week 24||2.4209|-5.5256|0.4377
73833468|NCT03043573|147214905|SUPERIORITY||Mean Difference (Final Values)|0.8937||||0.6813|TWO_SIDED|95.0|-3.4439|5.2312|||t-test, 2 sided|||Week 36||5.2312|-3.4439|0.6813
73833469|NCT03043573|147214905|SUPERIORITY||Mean Difference (Final Values)|2.9457||||0.162|TWO_SIDED|95.0|-1.2234|7.1148|||t-test, 2 sided|||||7.1148|-1.2234|0.1620
73833470|NCT03043573|147214906|SUPERIORITY||Mean Difference (Final Values)|0.0319||||0.9813|TWO_SIDED|95.0|-2.6668|2.7305|||t-test, 2 sided|||Baseline||2.7305|-2.6668|0.9813
73833471|NCT03043573|147214906|SUPERIORITY||Mean Difference (Final Values)|-0.0564||||0.9735|TWO_SIDED|95.0|-3.4397|3.3268|||t-test, 2 sided|||Week 6||3.3268|-3.4397|0.9735
73833472|NCT03043573|147214906|SUPERIORITY|Week 12|Mean Difference (Final Values)|1.0611||||0.5164|TWO_SIDED|95.0|-2.1885|4.3107|||t-test, 2 sided|||||4.3107|-2.1885|0.5164
73833473|NCT03043573|147214906|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.197|TWO_SIDED|95.0|-5.0651|1.0651|||t-test, 2 sided|||Week 24||1.0651|-5.0651|0.1970
73833474|NCT03043573|147214906|SUPERIORITY||Mean Difference (Net)|0.362||||0.8342|TWO_SIDED|95.0|-3.0907|3.8146|||t-test, 2 sided|||Week 36||3.8146|-3.0907|0.8342
73833475|NCT03043573|147214906|SUPERIORITY||Mean Difference (Final Values)|1.2667||||0.4717|TWO_SIDED|95.0|-2.2424|4.7758|||t-test, 2 sided|||Week 52||4.7758|-2.2424|0.4717
73833476|NCT03043573|147214907|SUPERIORITY||Mean Difference (Final Values)|-2.9318||||0.513|TWO_SIDED|95.0|-11.8176|5.9539|||t-test, 2 sided|||Baseline||5.9539|-11.8176|0.5130
73833477|NCT03043573|147214907|SUPERIORITY||Mean Difference (Final Values)|0.4835||||0.4835|TWO_SIDED|95.0|-15.2306|7.2967|||t-test, 2 sided|||Week 12||7.2967|-15.2306|0.4835
73833478|NCT03043573|147214907|SUPERIORITY||Mean Difference (Final Values)|-5.156||||0.359|TWO_SIDED|95.0|-16.3357|6.0238|||t-test, 2 sided|||Week 24||6.0238|-16.3357|0.3590
73833479|NCT03043573|147214907|SUPERIORITY||Mean Difference (Final Values)|1.1083||||0.876|TWO_SIDED|95.0|-13.1598|15.3765|||t-test, 2 sided|||Week 52||15.3765|-13.1598|0.8760
73833480|NCT03043573|147214908|SUPERIORITY||Mean Difference (Final Values)|-0.0606||||0.3248|TWO_SIDED|95.0|-0.1841|0.0628|||t-test, 2 sided|||Trails A Baseline||0.0628|-0.1841|0.3248
73833481|NCT03043573|147214908|SUPERIORITY||Mean Difference (Final Values)|-0.6953||||0.3615|TWO_SIDED|95.0|-2.2261|0.8354|||t-test, 2 sided|||Trails A - Week 12||0.8354|-2.2261|0.3615
73833482|NCT03043573|147214908|SUPERIORITY||Mean Difference (Final Values)|0.9917||||0.5046|TWO_SIDED|95.0|-1.9664|3.9498|||t-test, 2 sided|||Trails B - Baseline||3.9498|-1.9664|0.5046
73833483|NCT03043573|147214908|SUPERIORITY||Mean Difference (Final Values)|-2.0607||||0.0679|TWO_SIDED|95.0|-4.2821|0.1607|||t-test, 2 sided|||Trails B - Week 12||0.1607|-4.2821|0.0679
73833484|NCT03043573|147214908|SUPERIORITY||Mean Difference (Final Values)|-0.8929||||0.1669|TWO_SIDED|95.0|-2.1825|0.3968|||t-test, 2 sided|||Trails B - Week 24||0.3968|-2.1825|0.1669
73833485|NCT03043573|147214908|SUPERIORITY||Mean Difference (Final Values)|-1.4286||||0.2178|TWO_SIDED|95.0|-3.8115|0.9543|||t-test, 2 sided|||Trails B - Week 52||0.9543|-3.8115|0.2178
73833486|NCT03043573|147214909|SUPERIORITY||Mean Difference (Final Values)|1.558||||0.2932|TWO_SIDED|95.0|-1.3747|4.4908|||t-test, 2 sided|||Baseline||4.4908|-1.3747|0.2932
73833487|NCT03043573|147214909|SUPERIORITY||Mean Difference (Final Values)|1.7043||||0.2871|TWO_SIDED|95.0|-1.4659|4.8744|||t-test, 2 sided|||Week 6||4.8744|-1.4659|0.2871
73833488|NCT03043573|147214909|SUPERIORITY||Mean Difference (Final Values)|0.9167||||0.591|TWO_SIDED|95.0|-2.4737|4.307|||t-test, 2 sided|||Week 12||4.3070|-2.4737|0.5910
73833489|NCT03043573|147214909|SUPERIORITY||Mean Difference (Final Values)|-1.0238||||0.6128|TWO_SIDED|95.0|-5.0469|2.9993|||t-test, 2 sided|||||2.9993|-5.0469|0.6128
73833490|NCT03043573|147214909|SUPERIORITY||Mean Difference (Final Values)|1.9276||||0.3326|TWO_SIDED|95.0|-2.0231|5.8783|||t-test, 2 sided|||Week 36||5.8783|-2.0231|0.3326
73833491|NCT03043573|147214909|SUPERIORITY||Mean Difference (Final Values)|2.0741||||0.2935|TWO_SIDED|95.0|-1.8522|6.0004|||t-test, 2 sided|||Week 52||6.0004|-1.8522|0.2935
73833492|NCT00143507|147214919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.945|TWO_SIDED|95.0|0.91|1.1|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.10|0.91|0.945
73833493|NCT00143507|147214920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.316|TWO_SIDED|95.0|0.94|1.22|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.22|0.94|0.316
73833494|NCT00143507|147214921|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.159|TWO_SIDED|95.0|0.72|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.06|0.72|0.159
73833495|NCT00143507|147214922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.85|TWO_SIDED|95.0|0.86|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.13|0.86|0.850
73833496|NCT00143507|147214923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.547|TWO_SIDED|95.0|0.92|1.16|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.16|0.92|0.547
73833497|NCT00143507|147214924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.331|TWO_SIDED|95.0|0.71|1.12|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.12|0.71|0.331
73833498|NCT00143507|147214925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.078|TWO_SIDED|95.0|0.67|1.02|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.02|0.67|0.078
73833499|NCT00143507|147214926|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.583|TWO_SIDED|95.0|0.83|1.4|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.40|0.83|0.583
73833500|NCT00143507|147214927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.501|TWO_SIDED|95.0|0.81|1.11|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.11|0.81|0.501
73833501|NCT00143507|147214928|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.141|TWO_SIDED|95.0|0.78|1.04|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.04|0.78|0.141
73833502|NCT00143507|147214929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.411|TWO_SIDED|95.0|0.86|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.06|0.86|0.411
73833503|NCT00143507|147214930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.484|TWO_SIDED|95.0|0.94|1.15|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.15|0.94|0.484
73833504|NCT00143507|147214931|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.835|TWO_SIDED|95.0|0.9|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.13|0.90|0.835
73833505|NCT00879359|147214962|SUPERIORITY_OR_OTHER||Hazard Ratio, log|92.0|||||TWO_SIDED|95.0|64.0|99.0||||||||99|64|
73833506|NCT03915067|147214971|SUPERIORITY||Rate Difference|65.8|||<|0.0001|TWO_SIDED|95.0|51.5|80.1||P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.|Cochran-Mantel-Haenszel|||||80.1|51.5|<0.0001
73833507|NCT03915067|147214971|SUPERIORITY||Rate Difference|76.2|||<|0.0001|TWO_SIDED|95.0|63.6|88.9||P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.|Cochran-Mantel-Haenszel|||||88.9|63.6|<0.0001
73833508|NCT03915067|147214994|SUPERIORITY||Rate Difference|57.9|||<|0.0001|TWO_SIDED|95.0|42.3|73.5||P-value was derived from CMH model stratified by investigator site and P-APPS at Day 1.|Cochran-Mantel-Haenszel|||||73.5|42.3|<0.0001
73833509|NCT03915067|147214994|SUPERIORITY||Rate Difference|70.2|||<|0.0001|TWO_SIDED|95.0|56.4|84.1||P-value derived from CMH model stratified by investigator site and P-APPS at Day 1.|Cochran-Mantel-Haenszel|||||84.1|56.4|<0.0001
73833510|NCT02034591|147215010|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.682|||||TWO_SIDED|90.0|0.621|0.748||||||||0.748|0.621|
73833511|NCT02034591|147215011|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.813|||||TWO_SIDED|90.0|0.766|0.863||||||||0.863|0.766|
73833512|NCT02034591|147215012|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.81|||||TWO_SIDED|90.0|0.764|0.86||||||||0.860|0.764|
73833513|NCT02034591|147215013|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.884|||||TWO_SIDED|90.0|0.83|0.942||||||||0.942|0.830|
73833514|NCT02034591|147215014|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.95|||||TWO_SIDED|90.0|0.905|0.997||||||||0.997|0.905|
73833515|NCT02034591|147215015|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.947|||||TWO_SIDED|90.0|0.903|0.994||||||||0.994|0.903|
73833516|NCT01121926|147215039|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax,ss is between 80% and 125%.|Mean ratio|56.53|||||TWO_SIDED|90.0|49.99|63.94|||||Test/reference (%)|||63.94|49.99|
73833517|NCT01121926|147215040|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCss is between 80% and 125%.|Mean ratio|85.72|||||TWO_SIDED|90.0|81.05|90.67|||||Test/reference (%)|||90.67|81.05|
73833518|NCT03439514|147215081|SUPERIORITY||Median Difference (Net)|4.936||||0.818|TWO_SIDED|95.0|-24.246|34.118||Two-sided p-value|Van Elteren test||The Week 24 change from baseline in 6MWT between PF 07265803 and placebo was estimated using the stratified HL median difference, considering only participants who survived 24 weeks.|||34.118|-24.246|0.818
73833519|NCT03439514|147215087|OTHER||Hazard Ratio (HR)|0.43||||0.2257|TWO_SIDED|95.0|0.13|1.39|||Log Rank|||||1.39|0.13|0.2257
73833520|NCT03439514|147215088|OTHER||Hazard Ratio (HR)|1.19||||0.837|TWO_SIDED|95.0|0.3|4.63|||Log Rank|||||4.63|0.30|0.8370
73833521|NCT02175758|147215094|EQUIVALENCE|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||TWO_SIDED|90.0|109.96|152.48||||||AUCtau of GS-331007 for the 12 to \< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||152.48|109.96|
73833522|NCT02175758|147215094|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|109.8|||||TWO_SIDED|90.0|93.25|129.29||||||AUCtau of GS-331007 for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||129.29|93.25|
73833523|NCT02175758|147215094|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|149.67|||||TWO_SIDED|90.0|127.12|176.21||||||AUCtau of GS-331007 for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||176.21|127.12|
73833524|NCT02175758|147215096|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 12 to \< 18 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level. If superiority was demonstrated in the 12 to \< 18 Years Old group, then the SVR12 rate for participants aged 3 to \< 12 years would be compared with 80% at the 0.05 significance level.||||<0.001
73833525|NCT02175758|147215096|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 3 to \< 12 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.||||<0.001
73833526|NCT01047501|147215113|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-21.5|||<|0.0001|TWO_SIDED|95.0|-26.7|-16.2||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.||-16.2|-26.7|<0.0001
73833527|NCT01047501|147215113|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.1||||0.0005|TWO_SIDED|95.0|-15.7|-4.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-4.5|-15.7|0.0005
73833528|NCT01047501|147215114|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo with a significance level of 0.05. Non-inferiority tests for percent change from baseline in LDL-C were performed between AMR101 and placebo to determine if AMR101 was statistically non-inferior to placebo with regard to increases in LDL-C. The pre-specified LDL-C criterion for noninferiority was the upper boundary 97.5% confidence interval not crossing the +6% threshold.|Median Difference (Final Values)|-6.2||||0.0067|TWO_SIDED|95.0|-10.5|-1.7|||Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.||-1.7|-10.5|0.0067
73833529|NCT01047501|147215114|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo with a significance level of 0.05. Non-inferiority tests for percent change from baseline in LDL-C were performed between AMR101 and placebo to determine if AMR101 was statistically non-inferior to placebo with regard to increases in LDL-C. The pre-specified LDL-C criterion for noninferiority was the upper boundary 97.5% confidence interval not crossing the +6% threshold.|Median Difference (Final Values)|-3.6||||0.0867|TWO_SIDED|95.0|-7.9|0.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||0.5|-7.9|0.0867
73833530|NCT01047501|147215115|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-13.6||||0.0001|TWO_SIDED|95.0|-17.2|-9.9||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-9.9|-17.2|0.0001
73833531|NCT01047501|147215115|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.5||||0.014|TWO_SIDED|95.0|-9.4|-1.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-1.7|-9.4|0.0140
73833532|NCT01047501|147215116|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-24.4||||0.0001|TWO_SIDED|95.0|-31.9|-17.0||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-17.0|-31.9|0.0001
73833533|NCT01047501|147215116|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.5||||0.017|TWO_SIDED|95.0|-18.3|-2.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-2.5|-18.3|0.0170
73833534|NCT01047501|147215117|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.0||||0.0001|TWO_SIDED|95.0|-22.2|-15.7||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-15.7|-22.2|0.0001
73833535|NCT01047501|147215117|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.0||||0.0004|TWO_SIDED|95.0|-11.6|-4.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-4.5|-11.6|0.0004
73833536|NCT01047501|147215118|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-9.3||||0.0001|TWO_SIDED|95.0|-12.3|-6.1||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-6.1|-12.3|0.0001
73833537|NCT01047501|147215118|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-3.8||||0.017|TWO_SIDED|95.0|-6.9|-0.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-0.7|-6.9|0.0170
73833538|NCT00429299|147215121|NON_INFERIORITY_OR_EQUIVALENCE|An exploratory comparison between the combined two single anti-HER2 arms and the dual anti-HER2 arm was performed (Arm 3 versus Arms 1 and 2).|percentage of participants|25.0||||0.019||90.0|13.1|36.9||Exploratory analysis|Chi-squared||The estimated value represents the percentage of particpants in the CT plus trastuzumab treatment group with pathological complete response.|||36.9|13.1|0.019
73833539|NCT00429299|147215121|SUPERIORITY_OR_OTHER||percentage of participants|26.3||||||90.0|14.5|38.1|||||The estimated value represents the percentage of particpants in the CT plus lapatinib 1500 mg treatment group with pathological complete response.|||38.1|14.5|
73833540|NCT00429299|147215121|SUPERIORITY_OR_OTHER||percentage of participants|46.7|||||TWO_SIDED|90.0|34.4|58.9|||||The estimated value represents the percentage of particpants in the CT plus traztuzumab plus lapatinib 1000 mg treatment group with pathological complete response.|||58.9|34.4|
73833541|NCT03927157|147215132|SUPERIORITY||Rate Ratio|0.26|||<|0.001|TWO_SIDED|95.0|0.17|0.39|||Negative Binomial Regression|||||0.39|0.17|<0.001
73833542|NCT03927157|147215133|SUPERIORITY||Least Squares Mean Difference|0.24|||<|0.001|TWO_SIDED|95.0|0.16|0.32|||Mixed Models Analysis|||||0.32|0.16|<0.001
73833543|NCT03927157|147215134|SUPERIORITY||Least Squares Means Difference|0.35||||0.001|TWO_SIDED|95.0|0.14|0.55|||Mixed Models Analysis|||||0.55|0.14|0.001
73833544|NCT03927157|147215135|SUPERIORITY||Least Squares Means Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.47|-0.15|||Mixed Models Analysis|||||-0.15|-0.47|<0.001
73833545|NCT03927157|147215136|SUPERIORITY||Least Squares Means Difference|-0.16||||0.001|TWO_SIDED|95.0|-0.27|-0.06|||Mixed Models Analysis|||||-0.06|-0.27|0.001
73833546|NCT04871113|147215160|OTHER||Emax|-1.848|||||TWO_SIDED|95.0|-2.225|-1.472|||||Emax is defined as maximum response.|||-1.472|-2.225|
73833547|NCT04871113|147215160|OTHER||EC50|68.578|||||TWO_SIDED|95.0|15.866|121.29|||||EC50 is defined as the dose (in mg) that attains the 50% of the maximal effect.|||121.290|15.866|
73833548|NCT04871113|147215160|OTHER||s2e|0.257|||||TWO_SIDED|95.0|0.145|0.368|||||e is defined as random error assumed to be normally distributed with mean zero and constant variance (s2).|||0.368|0.145|
73833549|NCT00315822|147215186|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94||||0.8|TWO_SIDED|95.0|0.52|1.68|||Cochran-Mantel-Haenszel|||||1.68|0.52|0.80
73833550|NCT01257542|147215187|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.252|TWO_SIDED|95.0|0.59|1.15||p-value was calculated using negative binomial regression model with treatment, site and baseline of cough count terms with log (exposure time) as the offset parameter.|Negative binomial regression|||Odds Ratio and corresponding 95 percent (%) confidence interval (CI) were assessed from the negative binomial regression model.||1.15|0.59|0.252
73833551|NCT01257542|147215188|SUPERIORITY_OR_OTHER||LS mean difference|-0.26||||0.134|TWO_SIDED|95.0|-0.6|0.08||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on least-square (LS) means from analysis of variance (ANOVA) model.||0.08|-0.60|0.134
73833552|NCT01257542|147215189|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.768|TWO_SIDED|95.0|-0.45|0.33||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.33|-0.45|0.768
73833553|NCT01257542|147215189|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.358|TWO_SIDED|95.0|-0.64|0.23||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.23|-0.64|0.358
73833554|NCT01257542|147215189|SUPERIORITY_OR_OTHER||LS mean difference|-0.32||||0.139|TWO_SIDED|95.0|-0.74|0.1||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.10|-0.74|0.139
73896651|NCT00955201|147326623|SUPERIORITY|||||||0.69||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.69
73833555|NCT01257542|147215189|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.364|TWO_SIDED|95.0|-0.68|0.25||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.25|-0.68|0.364
73833556|NCT01257542|147215189|SUPERIORITY_OR_OTHER||LS mean difference|-0.46||||0.039|TWO_SIDED|95.0|-0.9|-0.02||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||-0.02|-0.90|0.039
73833557|NCT01257542|147215189|SUPERIORITY_OR_OTHER||LS mean difference|-0.29||||0.206|TWO_SIDED|95.0|-0.75|0.16||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.16|-0.75|0.206
73833558|NCT01257542|147215190|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.304|TWO_SIDED|95.0|-1.43|0.45||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.45|-1.43|0.304
73833559|NCT01257542|147215191|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.954|TWO_SIDED|95.0|-1.03|0.97||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.97|-1.03|0.954
73833560|NCT01257542|147215191|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.426|TWO_SIDED|95.0|-1.54|0.65||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.65|-1.54|0.426
73833561|NCT01257542|147215191|SUPERIORITY_OR_OTHER||LS mean difference|-0.45||||0.396|TWO_SIDED|95.0|-1.49|0.6||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.60|-1.49|0.396
73833562|NCT01257542|147215191|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.402|TWO_SIDED|95.0|-1.63|0.66||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.66|-1.63|0.402
73833563|NCT01257542|147215191|SUPERIORITY_OR_OTHER||LS mean difference|-0.69||||0.204|TWO_SIDED|95.0|-1.75|0.38||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.38|-1.75|0.204
73833564|NCT01257542|147215191|SUPERIORITY_OR_OTHER||LS mean difference|-0.84||||0.179|TWO_SIDED|95.0|-2.06|0.39||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.39|-2.06|0.179
73833565|NCT01257542|147215192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.523|TWO_SIDED|95.0|-0.21|0.39||p-value was calculated from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.||0.39|-0.21|0.523
73833566|NCT01257542|147215193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.796|TWO_SIDED|95.0|-0.35|0.24||p-value was calculated from the CMH test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.||0.24|-0.35|0.796
73833568|NCT00693303|147215217|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||||||.27
73833569|NCT03487445|147215222|SUPERIORITY|The statistical analysis comprised a 2-step testing strategy. The first test, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 50% (null hypothesis: proportion of responders \<50%) and is reported below. The second step for the Selatogrel 8 mg is described in statistical analysis 2: In this second analysis the subsequent null hypothesis of treatment effect less or equal to 85% was tested for the 8 mg dose.|||||<|0.001||||||P-value for hypotheses (H0: p \<= 50% vs. H1: p \> 50%)|one-sided z-test|A p-value significance level was set to 0.025.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||<0.001
73833570|NCT03487445|147215222|SUPERIORITY|This statistical analysis reports the second of the 2-step testing strategy. This second test for the 8 mg Selatogrel dose, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 85% (null hypothesis: proportion of responders \<85%).||||||0.142||||||P-value for hypotheses (H0: p \<= 85% vs. H1: p \> 85%)|one-sided z-test|A p-value significance level was set to 0.025, an overall level of 0.05 and adjusted for multiplicity using the Bonferroni approach.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||0.142
73833571|NCT03487445|147215222|SUPERIORITY|The statistical analysis comprised a 2-step testing strategy. The first test, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 50% (null hypothesis: proportion of responders \<50%) and is reported below. The second step for the Selatogrel 16 mg is described in statistical analysis 4: In this second analysis the subsequent null hypothesis of treatment effect less or equal to 85% was tested for the 16 mg dose.|||||<|0.0001||||||P-value for hypotheses (H0: p \<= 50% vs. H1: p \> 50%)|one-sided z-test|A p-value significance level was set to 0.025.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||<0.0001
73896652|NCT00955201|147326623|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
73833572|NCT03487445|147215222|SUPERIORITY|This statistical analysis reports the second of the 2-step testing strategy. This second test for the 16 mg Selatogrel dose, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 85% (null hypothesis: proportion of responders \<85%).||||||0.009||||||P-value for hypotheses (H0: p \<= 85% vs. H1: p \> 85%)|one-sided z-test|A p-value significance level was set to 0.025, an overall level of 0.05 and adjusted for multiplicity using the Bonferroni approach.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||0.009
73833573|NCT03487445|147215223|SUPERIORITY|||||||0.228||||||P-value for hypotheses (H0: p \<= 85% versus H1: p \> 85%)|One-sided Z-test|||As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.||||0.2280
73833574|NCT03487445|147215223|SUPERIORITY|||||||0.0201||||||P-value for hypotheses (H0: p \<= 85% versus H1: p \> 85%)|One-sided Z-test|||As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.||||0.0201
73833575|NCT03301714|147215229|EQUIVALENCE|equivalence analysis|Mean Difference (Final Values)|7.62||||0|TWO_SIDED|95.0||||baseline demographics, correlated errors due to repeated measures, and bias due to lost to follow-up were accounted for via Generalized Estimating Equation (statistical threshold \<0.01)|Regression, Linear||Mean change difference in oral health related quality of life among control, intervention 1: group-based oral health education and intervention 2: individual-based oral health education using motivational interviewing.|||||.000
73833576|NCT01251861|147215233|SUPERIORITY|||||||0.28||||||one-sided|Fisher Exact|||||||0.28
73833577|NCT01251861|147215242|OTHER|The association between PSA response (responder vs non-responder) and Gleason score (\<7, 7 vs. \>7) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.5||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and Gleason score (\<7, 7 vs. \>7) was evaluated by logistic regression with adjustment for treatment assignment.||||0.50
73833578|NCT01251861|147215243|OTHER|The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.28||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.||||0.28
73833579|NCT05643794|147215267|SUPERIORITY||Difference from Placebo|-0.54||||0.129|TWO_SIDED|95.0|-1.24|0.16|||Longitudinal linear mixed effect model||The difference presented is RLZ 12 weeks minus Placebo.|||0.16|-1.24|0.129
73833580|NCT05643794|147215270|SUPERIORITY||Difference from Placebo|-0.51||||0.358|TWO_SIDED|95.0|-1.6|0.58|||Longitudinal mixed effects model||The difference presented is RLZ 24 weeks minus PBO 24 weeks.|||0.58|-1.60|0.358
73833581|NCT05643794|147215271|SUPERIORITY||Difference from Placebo|-8.4||||0.003|TWO_SIDED|95.0|-13.84|-2.96|||Longitudinal mixed effects model||The difference presented is RLZ 12 weeks minus Placebo|||-2.96|-13.84|0.003
73833582|NCT05643794|147215272|SUPERIORITY||Differences from Placebo|0.05||||0.878|TWO_SIDED|95.0|-0.55|0.64|||Longitudinal mixed effects model||The differences presented is RLZ 12 weeks minus Placebo.|||0.64|-0.55|0.878
73833583|NCT05643794|147215273|SUPERIORITY||Difference from Placebo|-0.28||||0.352|TWO_SIDED|95.0|-0.86|0.31|||Longitudinal mixed effects model||The difference presented is RLZ 12 weeks minus Placebo.|||0.31|-0.86|0.352
73833584|NCT04167670|147215280|NON_INFERIORITY|P-value based on a Farrington and Manning test with a noninferiority margin of 10%.|Percentage Difference|-0.3||||0.0037|TWO_SIDED|95.0|-7.39|6.76|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Noninferiority of vonoprazan dual therapy to lansoprazole triple therapy.||6.76|-7.39|0.0037
73833585|NCT04167670|147215280|NON_INFERIORITY|P-value based on a Farrington and Manning test with a noninferiority margin of 10%.|Percentage Difference|5.9|||<|0.0001|TWO_SIDED|95.0|-0.75|12.62|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Noninferiority of vonoprazan triple therapy to lansoprazole triple therapy.||12.62|-0.75|<0.0001
73833586|NCT04167670|147215281|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|37.7|||<|0.0001|TWO_SIDED|95.0|20.54|52.56|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan dual therapy to lansoprazole triple therapy.||52.56|20.54|<0.0001
73833587|NCT04167670|147215281|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|33.8|||<|0.0001|TWO_SIDED|95.0|17.74|48.12|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan triple therapy to lansoprazole triple therapy.||48.12|17.74|<0.0001
73833588|NCT04167670|147215282|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|8.7||||0.0063|TWO_SIDED|95.0|1.86|15.44|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan dual therapy to lansoprazole triple therapy.||15.44|1.86|0.0063
73833589|NCT04167670|147215282|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|12.3||||0.0001|TWO_SIDED|95.0|5.72|18.81|||Farrington and Manning test|||Superiority of vonoprazan triple therapy to lansoprazole triple therapy.|The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|18.81|5.72|0.0001
73833590|NCT03720847|147215332|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.012|TWO_SIDED||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|||||.012
73833591|NCT03720847|147215333|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.03|TWO_SIDED||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates a greater perimenstrual increase in the outcome in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.030
73833592|NCT03720847|147215334|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.013|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.013
73833593|NCT03720847|147215335|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.018|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual change in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.018
73833594|NCT03720847|147215336|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.073|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.073
73833595|NCT03720847|147215337|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.25|TWO_SIDED||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.25
73833596|NCT03720847|147215338|SUPERIORITY||Mean Difference (Final Values)|-1.32||||0.23|TWO_SIDED||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.23
73833597|NCT02734667|147215345|SUPERIORITY||t statistic from GLM/regression|-0.47||||0.64|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.64
73833598|NCT02734667|147215346|SUPERIORITY||t-statistic from GLM/regression results|-2.6||||0.013|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.013
73833599|NCT02734667|147215347|SUPERIORITY||t-statistic from GLM/regression results|3.12||||0.003|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.003
73833600|NCT01115231|147215369|OTHER|multivariable logistic regression model|Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.93|4.42||||||||4.42|0.93|
73833601|NCT04307394|147215381|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|||||||0.957
73833602|NCT03928327|147215386|OTHER||Geometric Least Squares (LS) Mean Ratio|2.86|||||TWO_SIDED|90.0|2.48|3.3|||||Linear mixed-effects model was used for analysis, using fixed-effect(treatment), random-effect(participants). Geometric mean ratios(GMR), 90% confidence interval(CI) calculated using exponentiation of treatment least squares means(LSMs) difference.|||3.30|2.48|
73833603|NCT03928327|147215387|OTHER||Geometric LS Mean Ratio|0.08|||||TWO_SIDED|90.0|0.07|0.11|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||0.11|0.07|
73833604|NCT03928327|147215388|OTHER||Geometric LS Mean Ratio|6.27|||||TWO_SIDED|90.0|5.2|7.56|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||7.56|5.20|
73833605|NCT03928327|147215389|OTHER||Geometric LS Mean Ratio|0.05|||||TWO_SIDED|90.0|0.04|0.07|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||0.07|0.04|
73833606|NCT04900272|147215398|OTHER|||||||0.785|||||||ANOVA|||||||0.785
73833607|NCT04900272|147215399|OTHER|||||||0.583|||||||ANOVA|||||||0.583
73833608|NCT04900272|147215400|OTHER|||||||0.5015|||||||ANOVA|||||||0.5015
73833609|NCT04900272|147215401|OTHER|||||||0.3536|||||||ANOVA|||||||0.3536
73833610|NCT04900272|147215402|OTHER|||||||0.2688|||||||ANOVA|||||||0.2688
73833611|NCT04900272|147215403|OTHER|||||||0.728|||||||ANOVA|||||||0.728
73833612|NCT04900272|147215404|OTHER|||||||0.473|||||||ANOVA|||||||0.473
73833613|NCT04900272|147215405|OTHER|||||||0.4161|||||||ANOVA|||||||0.4161
73833614|NCT04900272|147215406|OTHER|||||||0.3356|||||||ANOVA|||||||0.3356
73833615|NCT04900272|147215407|OTHER|||||||0.9825|||||||ANOVA|||||||0.9825
73833616|NCT01846871|147215423|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
73833617|NCT01846871|147215424|OTHER|||||||0.028|||||||t-test, 2 sided|||||||0.028
73833618|NCT01846871|147215425|OTHER|||||||0.0019|||||||t-test, 2 sided|||||||0.0019
73833619|NCT01846871|147215426|OTHER|||||||0.033|||||||t-test, 2 sided|||||||0.033
73833620|NCT00081458|147215427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||ANCOVA|||||||0.007
73833621|NCT00081458|147215428|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||ANCOVA|||An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.||||0.005
73833622|NCT03384966|147215454|SUPERIORITY||Odds Ratio (OR)|58.9|||<|0.0001|TWO_SIDED|97.5|22.4|154.8||A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).|Chi-squared|||"The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.~No imputation was considered for handling missing values."||154.8|22.4|< 0.0001
73896653|NCT00955201|147326623|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
73896654|NCT00955201|147326623|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at baseline||||0.45
73833623|NCT03384966|147215454|SUPERIORITY||Odds Ratio (OR)|61.2|||<|0.0001|TWO_SIDED|97.5|23.1|162.3||A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).|Chi-squared|||"The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.~No imputation was considered for handling missing values in the main analysis."||162.3|23.1|< 0.0001
73833624|NCT03384966|147215458|OTHER|Logistic regression (Type III analysis)||||||0.1915|||||||Chi-squared|||||||0.1915
73833625|NCT03384966|147215460|OTHER||LS Mean difference with placebo|-27.49|||<|0.0001|TWO_SIDED|95.0|-35.4|-19.6|||Mixed Models Analysis|P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach.||Longitudinal analysis of the treatment effect, from start of treatment to 8 hours after injection.||-19.6|-35.4|<.0001
73833626|NCT03384966|147215460|OTHER||LS Mean difference with placebo|-31.06|||<|0.0001|TWO_SIDED|95.0|-39.0|-23.1|||Mixed Models Analysis|P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach||Longitudinal analysis of the treatment effect, from start of treatment up to 8 hours after injection.||-23.1|-39.0|<.0001
73833627|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.82|4.38|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual. Sample sizing calculated based on results from previous methodology studies performed using the same cold pain test; primary criteria was ability to detect a significant gabapentin effect over placebo.||4.38|-3.82|
73833628|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.53|4.68|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.68|-3.53|
73833629|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.99|4.22|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.22|-3.99|
73833630|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-1.15|5.44|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||5.44|-1.15|
73833631|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.18|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-14.48|-7.89|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-7.89|-14.48|
73833632|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|90.0|2.2|8.78|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||8.78|2.20|
73833633|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|90.0|-5.53|4.08|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.08|-5.53|
73833634|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|90.0|-18.74|-9.13|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-9.13|-18.74|
73833635|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.88|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|90.0|-2.01|7.78|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||7.78|-2.01|
73833636|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|3.66|||TWO_SIDED|90.0|-5.32|6.96|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||6.96|-5.32|
73833637|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.12|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|90.0|-19.14|-7.09|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-7.09|-19.14|
73833638|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|90.0|-4.45|7.6|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||7.60|-4.45|
73833639|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-7.39|2.32||||||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||2.32|-7.39|
73833640|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.59|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-14.44|-4.73|||Mixed Models Analysis|||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-4.73|-14.44|
73833641|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-4.85|4.85|||Mixed Models Analysis|||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.85|-4.85|
73833642|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-3.23|4.22|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.22|-3.23|
73833643|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.47|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-11.19|-3.75|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-3.75|-11.19|
73896655|NCT00955201|147326623|SUPERIORITY|||||||0.91|||||||ANOVA|||Comparison across groups at 12-wks||||0.91
73833644|NCT01119222|147215474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-3.99|3.45|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||3.45|-3.99|
73833645|NCT01119222|147215475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-4.24|3.04|||Mixed Models Analysis|||||3.04|-4.24|
73833646|NCT01119222|147215475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.43|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-13.07|-5.79|||Mixed Models Analysis|||||-5.79|-13.07|
73833647|NCT01119222|147215475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-2.8|4.48|||Mixed Models Analysis|||||4.48|-2.80|
73833648|NCT04837521|147215517|SUPERIORITY||γ01|0.25||||0.03|TWO_SIDED||||||t-test, 2 sided||analysis completed using the 1 week follow up data|||||.03
73833649|NCT04837521|147215518|OTHER|The conditions were expected to be similar, and the primary interest of the analysis was changes over time across both groups.|Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|2.32|4.49||To estimate the mean improvement in PSFS across the entire sample, we calculated a posterior predictive distribution of within-person change scores between time fixed equal to 0 and equal to -1.|Bayesian framework|||PSFS scores were analyzed using mixed-effects linear growth models with time, treatment condition, and their interaction as predictors. Random effects modeled variation in intercepts, slopes over time, and their covariance. Time was specified as a continuous variable, centered on the final observation date. The SG group served as the reference level for the treatment factor. Models were estimated in a Bayesian framework using default priors in the brms package.||4.49|2.32|
73833650|NCT00221104|147215536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8234|TWO_SIDED|95.0|0.73|1.29|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||1.29|0.73|0.8234
73833651|NCT00221104|147215537|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.0047|TWO_SIDED|95.0|0.15|0.74|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||0.74|0.15|0.0047
73833652|NCT00221104|147215538|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.3075|TWO_SIDED|95.0|0.81|1.91|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||1.91|0.81|0.3075
73833653|NCT00221104|147215539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36||||0.1986|TWO_SIDED|95.0|0.61|9.14|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||9.14|0.61|0.1986
73833654|NCT00221104|147215540|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9953|TWO_SIDED|95.0|0.45|2.22|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||2.22|0.45|0.9953
73833655|NCT02989389|147215547|SUPERIORITY||Mean Difference (Final Values)|-11.57||||0.215|TWO_SIDED|90.0|-29.52|10.96|||Mixed Models Analysis|||Aβ 1-40||10.96|-29.52|0.215
73833656|NCT02989389|147215547|SUPERIORITY||Mean Difference (Final Values)|-60.53|||<|0.001|TWO_SIDED|90.0|-69.79|-48.43|||Mixed Models Analysis|||Aβ 1-40||-48.43|-69.79|<0.001
73833657|NCT02989389|147215547|SUPERIORITY||Mean Difference (Final Values)|-87.07|||<|0.001|TWO_SIDED|90.0|-90.21|-82.92|||Mixed Models Analysis|||Aβ 1-40||-82.92|-90.21|<0.001
73833658|NCT02989389|147215547|SUPERIORITY||Mean Difference (Final Values)|-19.6||||0.015|TWO_SIDED|90.0|-33.69|-2.51|||Mixed Models Analysis|||Aβ 1-42||-2.51|-33.69|0.015
73833659|NCT02989389|147215547|SUPERIORITY||Mean Difference (Final Values)|-65.41|||<|0.001|TWO_SIDED|90.0|-72.23|-56.92|||Mixed Models Analysis|||Aβ 1-42||-56.92|-72.23|<0.001
73833660|NCT02989389|147215547|SUPERIORITY||Mean Difference (Final Values)|-84.56|||<|0.001|TWO_SIDED|90.0|-88.97|-78.38|||Mixed Models Analysis|||Aβ 1-42||-78.38|-88.97|<0.001
73833661|NCT04470427|147215548|OTHER||VE|93.2|||<|0.0001|TWO_SIDED|95.0|91.0|94.8|||Vaccine Efficacy (VE)|VE (percent) is demonstrated if the lower limit of the 2-sided confidence interval for the VE is above 30%.|VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|"Vaccine efficacy was defined as the percent reduction in the hazard of the primary endpoint (mRNA-1273 vs. placebo).~Null hypothesis of Vaccine Efficacy ≤30%, 95% CI."||94.8|91.0|<.0001
73833662|NCT04470427|147215554|OTHER||VE|98.2|||||TWO_SIDED|95.0|92.8|99.6|||VE||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||99.6|92.8|
73896656|NCT00955201|147326623|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 24-wks||||0.51
73833663|NCT04470427|147215555|OTHER||VE|82.0|||||TWO_SIDED|95.0|79.5|84.2|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model|||84.2|79.5|
73833664|NCT04470427|147215556|OTHER|VE|VE|93.4|||||TWO_SIDED|95.0|91.4|94.9|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||94.9|91.4|
73833665|NCT04470427|147215558|OTHER||VE|93.3|||||TWO_SIDED|95.0|91.1|94.9|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||94.9|91.1|
73833666|NCT04470427|147215559|OTHER||VE|82.0|||||TWO_SIDED|95.0|79.5|84.3|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||84.3|79.5|
73833667|NCT04470427|147215560|OTHER||VE|63.0|||||TWO_SIDED|95.0|56.6|68.5|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||68.5|56.6|
73833668|NCT04470427|147215566|NON_INFERIORITY|Non-inferiority of a booster as compared with mRNA-1273 after second dose based on Ratio of GMC is demonstrated if lower bound of 95% CI of Ratio of GMC ≥ 0.67.|Ratio of GMC|6.996|||||TWO_SIDED|95.0|6.509|7.52||||||Ratio of GMC 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57).||7.520|6.509|
73833669|NCT04470427|147215567|NON_INFERIORITY|Non-inferiority of a booster as compared with mRNA-1273 after second dose based on SRR difference is demonstrated if lower bound of 95% CI of SRR difference \> -10%.|Difference in Seroresponse|0.9|||||TWO_SIDED|95.0|0.1|1.8|||||95% CI were calculated using adjusted Wald method for the paired binary data.|Seroresponse 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57)||1.8|0.1|
73833670|NCT02232698|147215605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.239|<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
73833671|NCT02232698|147215606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.059||0.9556|TWO_SIDED||||||ANCOVA|||||||0.9556
73833672|NCT02232698|147215607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.175|<|0.0001|TWO_SIDED|||||Statistical analysis of time spent \<55 mg/dL|ANCOVA|||||||<0.0001
73833673|NCT02232698|147215607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.122||0.0003|TWO_SIDED|||||Statistical analysis of time spent \<40 mg/dL|ANCOVA|||||||0.0003
73833674|NCT02232698|147215608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<70 mg/dL||||<0.0001
73833675|NCT02232698|147215608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<55 mg/dL||||<0.0001
73833676|NCT02232698|147215608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<40 mg/dL||||<0.0001
73833677|NCT02232698|147215609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.329||0.5623|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>180 mg/dL||||0.5623
73833678|NCT02232698|147215609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.163||0.0247|TWO_SIDED||||||ANCOVA|||Statistical analysis for time spent \>240 mg/dL||||0.0247
73833679|NCT02232698|147215610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0006|TWO_SIDED||||||ANCOVA|||||||0.0006
73833680|NCT02232698|147215613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of perceived frequency of hyperglycaemia||||<0.0001
73833681|NCT02232698|147215613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0713|TWO_SIDED||||||ANCOVA|||Statistical analysis of perceived frequency of hypoglycaemia||||0.0713
73833682|NCT02232698|147215613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of total treatment satisfaction score||||<0.0001
73833683|NCT02337946|147215620|SUPERIORITY||Difference of PFS rate between groups|0.9|||||TWO_SIDED|95.0|-17.2|19.0|||||||Agresti-Caffo method was used for estimation of 95% CI.|19.0|-17.2|
73833684|NCT02337946|147215621|SUPERIORITY||Adjusted Hazard Ratio (HR)|0.93||||0.7349|TWO_SIDED|95.0|0.6|1.43|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||1.43|0.60|0.7349
73833685|NCT02337946|147215622|SUPERIORITY||Adjusted Hazard Ratio (HR)|1.41||||0.3485|TWO_SIDED|95.0|0.69|2.88|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||2.88|0.69|0.3485
73833686|NCT02337946|147215624|SUPERIORITY||Multivariable Hazard Ratio (HR)|0.9||||0.5901|TWO_SIDED|95.0|0.6|1.33|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||1.33|0.60|0.5901
73833687|NCT02949934|147215633|SUPERIORITY|||||||0.013|||||||ANCOVA|Covariates were age, baseline AUDIT score, baseline drinks per day, and whether participant participated before vs. during the COVID-19 pandemic.||Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group.||||0.013
73833688|NCT02949934|147215634|SUPERIORITY|||||||0.014|||||||ANCOVA|Covariates were age, baseline AUDIT score, and baseline drinks per day.||Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group||||0.014
73833689|NCT02949934|147215635|SUPERIORITY|||||||0.062|||||||Mixed Models Analysis|Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner||||||0.062
73833690|NCT02949934|147215636|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner||||||0.83
73833691|NCT02949934|147215636|SUPERIORITY|||||||0.026|||||||Mixed Models Analysis|Linear mixed model testing interaction between medication group and time, controlling for scanner||||||0.026
73833692|NCT04766333|147215659|SUPERIORITY||Odds Ratio (OR)|0.45|||<|0.05|TWO_SIDED|95.0|0.17|1.23|||Regression, Logistic||Healthcare Arm is the reference category|||1.23|0.17|<0.05
73833693|NCT00639379|147215660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.65|Odds Ratio (OR)|0.967|||||TWO_SIDED|98.98|0.436|0.967|||Regression, Logistic||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens orientation within 5 degrees.||0.967|0.436|
73833694|NCT00639379|147215661|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.65|Odds Ratio (OR)|1.416|||||TWO_SIDED|98.98|0.68|1.416|||Regression, Logistic||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens stability within 5 degrees.||1.416|0.680|
73833695|NCT00639379|147215662|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.4|Mean Difference (Final Values)|0.1868|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|98.98|-0.0517|0.1868|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for lens comfort.||0.1868|-0.0517|
73833696|NCT00639379|147215663|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.4|Mean Difference (Final Values)|-0.01185|STANDARD_ERROR_OF_MEAN|0.08566|||TWO_SIDED|98.98|-0.2337|-0.01185|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for subjective vision.||-0.01185|-0.2337|
73833697|NCT00639379|147215664|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.01267|STANDARD_ERROR_OF_MEAN|0.01265|||TWO_SIDED|98.98|-0.01267|0.01986|||||The mean difference was calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is senofilcon A toric is non-inferior to alphafilcon A toric by having a lower level of corneal staining.||0.01986|-0.01267|
73833698|NCT03712852|147215680|SUPERIORITY||Mean Difference (Net)|0.92|||||TWO_SIDED|95.0|0.68|1.17|||||||Multiple univariate analyses for each variable were performed. GT was analyzed by non-parametric Cliff's delta tests to assess group dominance and by a Heteroscedastic ANOVA with Games-Howell posthoc tests. A sensitivities analysis with different types of robust analyses (M-estimators and High Breakdown LTS Estimators, both with Huber's, Hampel's and Biweight's loss functions) was conducted to get an effect-size estimate by means of Bootstrap Bias Corrected and accelerated (BCa) 95% Confidence Intervals.|1.17|0.68|
73833699|NCT03712852|147215681|SUPERIORITY||Median Difference (Final Values)|3.28|||||TWO_SIDED|95.0|3.0|3.55|||||||This outcome was analyzed by posthoc Nemenyi's tests|3.55|3.00|
73833700|NCT03712852|147215682|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.46|2.46|||||||This outcome was analyzed by posthoc Nemenyi's tests|2.46|-0.46|
73833701|NCT03712852|147215683|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.4|0.69|||||||This outcome was analyzed by posthoc Nemenyi's tests|0.69|-0.40|
73833702|NCT03712852|147215684|SUPERIORITY||Mean Difference (Final Values)|3.38|||||TWO_SIDED|95.0|2.96|3.81|||||||CAL was analyzed with both Nemenyi's tests and a Moderated Regression (Treatment by Baseline values)|3.81|2.96|
73833703|NCT01771913|147215687|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.310
73833704|NCT01771913|147215688|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.026
73833705|NCT01771913|147215689|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Fisher Exact|||||||0.103
73833706|NCT00407511|147215690|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||End of treatment/last observation carried forward (EOT/LOCF): value consists of the mean of the last 7 post-baseline visits scores. Mean change: the arithmetic mean change and p-value from the single sample t-test. If \< = 7 and \> = 4 post-baseline scores were available, the mean pain score was computed using the available scores. The mean was not calculated if there were less than 4 post-baseline scores prior to study termination.||||< 0.0001
73833707|NCT00407511|147215691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4||-2.8|-3.6|< 0.0001
73833708|NCT00407511|147215691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.3|-3.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8||-3.5|-4.3|< 0.0001
73833709|NCT00407511|147215691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12||-3.7|-4.5|< 0.0001
73833710|NCT00407511|147215692|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.7|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8, FAS. Week 8: subjects were only included if their visit fell within the computed week (49 to 63 days).||-3.7|-4.7|< 0.0001
73833711|NCT00407511|147215692|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-5.1|-4.1|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (\>= 78 days).||-4.1|-5.1|< 0.0001
73833712|NCT00407511|147215692|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.||||< 0.0001
73833713|NCT00407511|147215693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.2|-3.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: subjects were only included if their visit fell within the computed week (Day 49 to 63).||-3.4|-4.2|< 0.0001
73833714|NCT00407511|147215693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (\>= Day 78)||-3.7|-4.5|< 0.0001
73833715|NCT00407511|147215693|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.||||< 0.0001
73833716|NCT00407511|147215696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.1|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-22.3|-14.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 1 assessment if their visit fell within Days 4 to 10.||-14.0|-22.3|< 0.0001
73896657|NCT00955201|147326624|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
73833717|NCT00407511|147215696|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-28.2|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-32.4|-24.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 2 assessment if their visit fell within Days 11 to 17.||-24.0|-32.4|< 0.0001
73833718|NCT00407511|147215696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.3|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-38.5|-30.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 3 assessment if their visit fell within Days 18 to 24.||-30.0|-38.5|< 0.0001
73833719|NCT00407511|147215696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.9|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-45.2|-36.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 4 assessment if their visit fell within days 25 to 35.||-36.7|-45.2|< 0.0001
73833720|NCT00407511|147215696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-45.8|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-50.2|-41.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 8 assessment if their visit fell within Days 49 to 63.||-41.4|-50.2|< 0.0001
73833721|NCT00407511|147215696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-48.4|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-52.8|-44.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 12 assessment if their visit fell \>= Day 78.||-44.0|-52.8|< 0.0001
73833722|NCT00407511|147215696|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change is the arithmetic mean change; p-value is from a single-sample t-test.||||< 0.0001
73833723|NCT00407511|147215697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-43.4|-33.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 8 assessment only if their visit fell within Days 49 and 63.||-33.9|-43.4|< 0.0001
73833724|NCT00407511|147215697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-45.5|-35.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 12 assessment only if their visit fell \>=Day 78.||-35.9|-45.5|< 0.0001
73833725|NCT00407511|147215697|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change= arithmetic mean change; p-value is from a single-sample t-test.||||< 0.0001
73833726|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.4|-0.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-0.7|-1.4|< 0.0001
73833727|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-2.2|-1.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-1.5|-2.2|< 0.0001
73833728|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-2.9|-2.2|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.2|-2.9|< 0.0001
73833729|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.2|-2.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.5|-3.2|< 0.0001
73833730|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.3|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 5: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.6|-3.3|< 0.0001
73833731|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.4|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 6: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.6|-3.4|< 0.0001
73833732|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.5|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 7: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.8|-3.5|< 0.0001
73833733|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.8|-3.6|< 0.0001
73833734|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-2.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 9: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.9|-3.7|< 0.0001
73833735|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 10: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.7|< 0.0001
73833736|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.8|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Visit 11: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.8|< 0.0001
73833737|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.7|< 0.0001
73833738|NCT00407511|147215698|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF value consists of the mean of the last 7 post-baseline sleep scores; mean change = arithmetic mean change; p-value: from single sample t-test.||||< 0.0001
73833739|NCT00195429|147215707|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.0
73833740|NCT00195429|147215708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||Student's t-test|||||||0.361
73833741|NCT04925934|147215729|SUPERIORITY||Rate Difference|2.8|||=|0.7474|TWO_SIDED|90.0|-11.4|17.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||17.0|-11.4|=0.7474
73833742|NCT04925934|147215729|SUPERIORITY||Rate Difference|-0.1|||=|0.9942|TWO_SIDED|90.0|-14.2|14.1|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||14.1|-14.2|=0.9942
73833743|NCT04925934|147215730|SUPERIORITY||Rate Difference|37.2|||=|0.1626|TWO_SIDED|90.0|-0.3|74.7|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.||74.7|-0.3|=0.1626
73833744|NCT04925934|147215730|SUPERIORITY||Rate Difference|24.1|||=|0.2873|TWO_SIDED|90.0|-7.5|55.8|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.||55.8|-7.5|=0.2873
73833745|NCT04925934|147215731|SUPERIORITY||Rate Difference|8.6|||=|0.322|TWO_SIDED|90.0|-5.6|22.7|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||22.7|-5.6|=0.3220
73833746|NCT04925934|147215731|SUPERIORITY||Rate Difference|2.9|||=|0.7364|TWO_SIDED|90.0|-11.2|17.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||17.0|-11.2|=0.7364
73833747|NCT04925934|147215732|SUPERIORITY||Rate Difference|11.7|||=|0.2805|TWO_SIDED|90.0|-6.1|29.4|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.||29.4|-6.1|=0.2805
73833748|NCT04925934|147215732|SUPERIORITY||Rate Difference|9.4|||=|0.3926|TWO_SIDED|90.0|-8.6|27.3|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.||27.3|-8.6|=0.3926
73833749|NCT04925934|147215733|SUPERIORITY||Rate Difference|16.5|||=|0.037|TWO_SIDED|90.0|4.0|29.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||29.0|4.0|=0.0370
73833750|NCT04925934|147215733|SUPERIORITY||Rate Difference|4.9|||=|0.4939|TWO_SIDED|90.0|-6.7|16.4|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||16.4|-6.7|=0.4939
73896658|NCT00955201|147326624|SUPERIORITY|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.72
73896659|NCT00955201|147326624|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
73833751|NCT03158688|147215739|SUPERIORITY||Stratified Cox model hazard ratio|0.63||||0.0014|TWO_SIDED|95.0|0.464|0.854||alpha level of 0.025|Log Rank||KdD/Kd|Stratification factors used in the Log-rank p-value (1-sided) and the Cox model hazard ratio (KdD/Kd) were as assessed at randomization: International Staging System stage at screening (Stage 1 or 2 vs Stage 3); prior proteasome inhibitor exposure (yes vs no); number of prior lines of therapy (1 vs \>= 2).||0.854|0.464|0.0014
73833752|NCT03158688|147215740|SUPERIORITY||Odds Ratio (OR)|1.925||||0.004|TWO_SIDED|95.0|1.184|3.129|||Cochran-Mantel-Haenszel||KdD/Kd|"Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.~P-values were calculated using the stratified Cochran-Mantel-Haenszel Chi-Square test."||3.129|1.184|0.0040
73833753|NCT03158688|147215741|SUPERIORITY||Odds Ratio (OR)|7.819|||||TWO_SIDED|95.0|2.364|25.858|||||KdD/Kd|Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.||25.858|2.364|
73833754|NCT03158688|147215742|SUPERIORITY||Cox Proportional Hazard|0.784||||0.0417|TWO_SIDED|95.0|0.595|1.033|||Log Rank||KdD/Kd|"Hazard ratio and corresponding 95% CIs were estimated using the stratified Cox proportional hazards models.~1-sided p-value from the log-rank test controlling for the randomization stratification factors."||1.033|0.595|0.0417
73833755|NCT03158688|147215751|SUPERIORITY||Odds Ratio (OR)|4.403|||||TWO_SIDED|95.0|2.007|9.656|||||KdD/Kd|Odds ratios and corresponding 95% CIs were estimated by a stratified analysis using the Mantel-Haenszel method.||9.656|2.007|
73833756|NCT03158688|147215752|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|1.24||0.948|TWO_SIDED|95.0|-2.52|2.35|||linear mixed effects model||The overall treatment difference (KdD - Kd)|Analysis was performed based on a linear mixed effects model. The model included fixed effects of treatment (all baseline responses were modeled with a dummy treatment), baseline QLQ-C30 GHS/QoL score, randomization stratification factors (ISS stage at screening (Stage 1 or 2 vs Stage 3), prior proteasome inhibitor exposure (yes vs no), number of prior lines of therapy (1 vs ≥ 2)), interaction between treatment and time, and random effects of participant intercept and random slope of time.||2.35|-2.52|0.9480
73833757|NCT03188185|147215775|SUPERIORITY|Hypothesis tests were two-sided with an alpha of 0.05 .|Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.99||0.128|TWO_SIDED|95.0|-3.5|0.4||ALK 5461 was compared to placebo using stage-specific MMRM for MADRS-10 Change from Baseline.Model-derived estimates were combined using equal weights|Mixed Models Analysis|||Analysis was conducted for each stage separately, and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2).||0.4|-3.5|0.128
73833758|NCT04822194|147215802|SUPERIORITY|||||||0.053|||||||Mixed Models Analysis|Ran linear mixed model, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously reported for within and between-subjects behavioral analyses of longitudinal reappraisal training data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects require 36 per group.||||0.053
73833759|NCT04822194|147215803|SUPERIORITY|||||||0.741|||||||Mixed Models Analysis|Ran linear mixed models on natural log of RMSSD, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously obtained for within and between-subjects analyses of respiratory sinus arrhythmia data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects should be achieved with 36 per group.||||0.741
73833760|NCT04822194|147215804|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|Ran linear mixed model, p-value above reflects a group by session interaction.||Null hypothesis: no difference between groups. Power analyses using a within-subject fMRI effect size estimate for right amygdala affective reactivity from a meta-analysis of Human Connectome Project data of approx. d=.70, applying to between-subjects effects as well, indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) to detect between-group effects should be achieved with 36 participants per group.||||0.021
73833761|NCT04822194|147215805|SUPERIORITY|||||||0.724|||||||Mixed Models Analysis|We ran linear mixed models, p-value reflects a group by session interaction for the UGRS composite scores.||Null hypothesis: no difference between groups. Power analyses of an effect size (d=.70) previously reported for within and between-subjects analyses of questionnaire outcomes (i.e., depressive symptoms, grief rumination, perceived stress, reappraisal usage) indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) for between-group effects should be achieved with 36 per group.||||0.724
73833762|NCT04822194|147215805|SUPERIORITY|||||||0.835|||||||Mixed Models Analysis|Ran linear mixed model on counterfactuals adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.835
73833763|NCT04822194|147215805|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|Ran linear mixed model on injustice adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups.||||0.090
73833764|NCT04822194|147215805|SUPERIORITY|||||||0.983|||||||Mixed Models Analysis|Ran linear mixed model on meaning adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.983
73833765|NCT04822194|147215805|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|Ran linear mixed model on reaction adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.760
73833766|NCT04822194|147215805|SUPERIORITY|||||||0.402|||||||Mixed Models Analysis|Ran linear mixed model on relations adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups.||||0.402
73833767|NCT04822194|147215806|SUPERIORITY|||||||0.092|||||||Mixed Models Analysis|We ran a linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.092
73833768|NCT04822194|147215807|SUPERIORITY|||||||0.585|||||||Mixed Models Analysis|Ran a linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.585
73833769|NCT04822194|147215808|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Ran linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.70
73833770|NCT04822194|147215809|SUPERIORITY|||||||0.696|||||||Mixed Models Analysis|Ran linear mixed model on emotional problems adjusted for covariates, p-value above reflects group by session interaction||Null hypothesis: no difference between groups.||||0.696
73833771|NCT04822194|147215809|SUPERIORITY|||||||0.452|||||||Mixed Models Analysis|Ran linear mixed model on emotional well-being adjusted for covariates, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.452
73833772|NCT04822194|147215809|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|Ran a linear mixed model on energy adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.650
73833773|NCT04822194|147215809|SUPERIORITY|||||||0.224|||||||Mixed Models Analysis|Ran linear mixed model on general health perceptions adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.224
73833774|NCT04822194|147215809|SUPERIORITY|||||||0.256|||||||Mixed Models Analysis|Ran linear mixed model on pain adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference in groups||||0.256
73833775|NCT04822194|147215809|SUPERIORITY|||||||0.984|||||||Mixed Models Analysis|Ran linear mixed model on physical function adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.984
73833776|NCT04822194|147215809|SUPERIORITY|||||||0.363|||||||Mixed Models Analysis|Ran linear mixed model on physical health adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.363
73833777|NCT04822194|147215809|SUPERIORITY|||||||0.045|||||||Mixed Models Analysis|Ran linear mixed model on social functioning adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.045
73833778|NCT04822194|147215810|SUPERIORITY|||||||0.422|||||||ANCOVA|Ran a repeated measures ANCOVA of logged IL-6 serum, p-value above reflects time by ER group interaction effect.||Null hypothesis: no difference between groups||||0.422
73833779|NCT04822194|147215810|SUPERIORITY|||||||0.438|||||||ANCOVA|Ran a repeated measures ANCOVA of TNFα, p-value above reflects time by ER group interaction effect.||Null hypothesis: no difference between groups||||0.438
73833780|NCT00248547|147215820|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon Rank Sum Test|||||||0.041
73833781|NCT02965833|147215824|SUPERIORITY||||||=|0.0073|||||||Mixed Models Analysis|||||||=0.0073
73833782|NCT04764539|147215854|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_DEVIATION|0.294|<|0.555|TWO_SIDED|95.0|-1.276|0.796||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|The Mean Length of Utterance (MLU) will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||0.796|-1.276|<0.555
73833783|NCT04764539|147215854|SUPERIORITY||Mean Difference (Final Values)|0.5383|STANDARD_DEVIATION|0.659|<|0.2128|TWO_SIDED|95.0|-0.471|1.548||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||1.548|-0.471|<0.2128
73833784|NCT04764539|147215854|SUPERIORITY||Mean Difference (Final Values)|0.298|STANDARD_DEVIATION|0.365|<|0.533|TWO_SIDED|95.0|-0.915|1.511||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||1.511|-0.915|<0.533
73833785|NCT04764539|147215855|SUPERIORITY||Mean Difference (Final Values)|1.388|STANDARD_DEVIATION|1.7|<|0.289|TWO_SIDED|95.0|-1.763|4.539||Sample size too small for statistical power. In addition, automated speech recognition for child speech had a very poor state-of-the-art at the time of this study.|ANOVA||Difference = (iPad Pro group - VR goggles group)|The percentage of correctly transcribed words using automatic speech recognition will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||4.539|-1.763|<0.289
73833786|NCT04764539|147215856|SUPERIORITY||Mean Difference (Final Values)|-3.51|STANDARD_DEVIATION|4.3||0.4296|TWO_SIDED|95.0|-49.68|42.66||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|Articulation Accuracy does not statistically differ for the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||42.66|-49.68|0.4296
73833787|NCT04764539|147215856|SUPERIORITY||Mean Difference (Final Values)|19.75|STANDARD_DEVIATION|24.19|<|0.294|TWO_SIDED|95.0|-25.7|65.2||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||65.2|-25.7|<0.294
73833788|NCT04764539|147215856|SUPERIORITY||Mean Difference (Final Values)|16.25|STANDARD_DEVIATION|19.9|<|0.419|TWO_SIDED|95.0|-33.86|66.36||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||66.36|-33.86|<0.419
73833789|NCT04764539|147215857|SUPERIORITY||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|1.63|<|0.659|TWO_SIDED|95.0|-6.436|9.096||Sample size to small for statistical power.|ANOVA||difference = (iPad group mean - VR goggles group mean)|||9.096|-6.436|<0.659
73833790|NCT04764539|147215858|SUPERIORITY||Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|9.67|<|0.789|TWO_SIDED|95.0|-68.91|84.7|||ANOVA|Sample size too small for statistical power.|Difference = (iPad Pro group - VR Goggles group)|||84.7|-68.91|<0.789
73833791|NCT04764539|147215858|SUPERIORITY||Mean Difference (Final Values)|30.16|STANDARD_DEVIATION|36.94|<|0.304|TWO_SIDED|95.0|-40.85|101.17||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||101.17|-40.85|<0.304
73833792|NCT04764539|147215858|SUPERIORITY||Mean Difference (Final Values)|22.26|STANDARD_DEVIATION|27.26|<|0.403|TWO_SIDED|95.0|-43.91|88.43||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||88.43|-43.91|<0.403
73833793|NCT04764539|147215859|SUPERIORITY||Mean Difference (Final Values)|-2.34|STANDARD_DEVIATION|2.87|<|0.485|TWO_SIDED|95.0|-10.79|6.11||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|The response to treatment stimuli will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||6.11|-10.79|<0.485
73833794|NCT04764539|147215859|SUPERIORITY||Mean Difference (Final Values)|5.66|STANDARD_DEVIATION|6.94|<|0.065|TWO_SIDED|95.0|-0.569|11.9||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||11.9|-0.569|<0.065
73833795|NCT04764539|147215859|SUPERIORITY||Mean Difference (Final Values)|3.34|STANDARD_DEVIATION|4.09|<|0.549|TWO_SIDED|95.0|-10.85|17.53||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||17.53|-10.85|<0.549
73833796|NCT02827708|147215874|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.0|<0.0001
73833797|NCT02827708|147215874|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.0|||<|0.0001||95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.2|<0.0001
73833798|NCT02827708|147215875|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.8|-3.2|<0.0001
73833799|NCT02827708|147215875|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.9||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.9|-3.5|<0.0001
73833800|NCT02827708|147215891|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.64|||=|0.1834|TWO_SIDED|95.0|0.34|1.23||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.23|0.34|=0.1834
73833801|NCT02827708|147215892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.43|||=|0.061|TWO_SIDED|95.0|0.17|1.04||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.04|0.17|=0.0610
73833802|NCT02383173|147215916|OTHER|||||||0.445|||||||Generalized Estimating Equation (GEE)|Sandwich estimators were used to adjust for the small number of clusters.||Generalized Estimating Equation (GEE) analyses of post-intervention data were used to account for clustering. We adjusted for age, race, cancer, length of stay and study year.||||0.445
73833803|NCT03677401|147215931|SUPERIORITY|P-value from a Cochran-Mantel- Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.||||||0.158|||||||Cochran-Mantel-Haenszel|||At Week 10||||0.158
73833804|NCT03677401|147215932|SUPERIORITY|P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.||||||0.75|||||||Cochran-Mantel-Haenszel|||At Week 4||||0.750
73833805|NCT03677401|147215933|SUPERIORITY|P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation||||||0.674|||||||Cochran-Mantel-Haenszel|||At Week 2||||0.674
73833806|NCT03677401|147215934|SUPERIORITY|P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.06|||||||ANCOVA|||At Week 2||||0.060
73833807|NCT03677401|147215934|SUPERIORITY|||||||0.401||||||P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.401
73833808|NCT03677401|147215934|SUPERIORITY|P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.185|||||||ANCOVA|||At Week 6||||0.185
73833809|NCT03677401|147215934|SUPERIORITY|P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.164|||||||ANCOVA|||At Week 10||||0.164
73833810|NCT03677401|147215935|SUPERIORITY|||||||0.283||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 2||||0.283
73833811|NCT03677401|147215935|SUPERIORITY|||||||0.701||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 4||||0.701
73833812|NCT03677401|147215935|SUPERIORITY|||||||0.033||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 10||||0.033
73833813|NCT03677401|147215936|SUPERIORITY|||||||0.797||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.797
73833814|NCT03677401|147215937|SUPERIORITY|||||||0.845||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.845
73833815|NCT03677401|147215938|SUPERIORITY|||||||0.385||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.385
73833816|NCT03677401|147215938|SUPERIORITY|||||||0.786||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.786
73833817|NCT03677401|147215938|SUPERIORITY|||||||0.502||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.502
73833818|NCT03677401|147215939|SUPERIORITY|||||||0.197||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.197
73833819|NCT03677401|147215939|SUPERIORITY|||||||0.694||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.694
73833820|NCT03677401|147215939|SUPERIORITY|||||||0.916||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.916
73833821|NCT01177410|147215941|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.369||||0.0432|TWO_SIDED|95.0|1.027|5.467|||Regression, Logistic|||||5.467|1.027|0.0432
73833822|NCT01177410|147215941|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.267||||0.6059|TWO_SIDED|95.0|0.515|3.115|||Regression, Logistic|||||3.115|0.515|0.6059
73833823|NCT01177410|147215942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.232||||0.0327|TWO_SIDED|95.0|1.068|4.664|||Proportional Odds Model|||Proportional odds model was used to compare the number of months the subjects are responders.||4.664|1.068|0.0327
73833824|NCT01177410|147215942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.148||||0.726|TWO_SIDED|95.0|0.531|2.483|||Proportional Odds Model|||||2.483|0.531|0.7260
73833825|NCT00924482|147215949|SUPERIORITY_OR_OTHER_LEGACY||Correlation Coefficient (R^2)|0.63||||||95.0|||||Regression, Linear|Linear regression between the average of six thermodilution cardiac output measurements was compared to the average of six ECOM output measurements||||||
73833826|NCT00875667|147215961|SUPERIORITY||Stratified Hazard Ratio|0.63||||0.012|TWO_SIDED|95.0|0.43|0.9||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test|||||0.90|0.43|0.012
73833827|NCT00875667|147215962|SUPERIORITY||Stratified Hazard Ratio|0.6||||0.003|TWO_SIDED|95.0|0.43|0.85||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test||The weights are based on observed events at the time the third DMC meeting was held and based on the difference between observed and expected events at the time of the primary analysis.|||0.85|0.43|0.003
73833828|NCT00875667|147215963|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73833829|NCT00875667|147215964|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73833830|NCT00875667|147215965|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.421|TWO_SIDED|95.0|0.29|1.68|||Log Rank|||||1.68|0.29|0.421
73833831|NCT00875667|147215966|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.875|TWO_SIDED|95.0|0.52|1.74|||Log Rank|||||1.74|0.52|0.875
73833832|NCT00875667|147215967|SUPERIORITY|||||||0.313|||||||Chi-squared|||||||0.313
73833833|NCT00875667|147215968|SUPERIORITY|||||||0.465|||||||Chi-squared|||||||0.465
73833834|NCT00875667|147215969|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.005|TWO_SIDED|95.0|0.45|0.87|||Log Rank|||||0.87|0.45|0.005
73833835|NCT00875667|147215970|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.003|TWO_SIDED|95.0|0.46|0.86|||Log Rank|||||0.86|0.46|0.003
73833836|NCT00875667|147215971|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.046|TWO_SIDED|95.0|0.54|1.0|||Log Rank|||||1.00|0.54|0.046
73833837|NCT00875667|147215972|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.095|TWO_SIDED|95.0|0.58|1.05|||Log Rank|||||1.05|0.58|0.095
73833838|NCT00875667|147215973|SUPERIORITY||Hazard Ratio (HR)|3.91|||<|0.001|TWO_SIDED|95.0|1.95|7.85|||Log Rank|||||7.85|1.95|<0.001
73833839|NCT00875667|147215974|SUPERIORITY||Hazard Ratio (HR)|2.06|||<|0.004|TWO_SIDED|95.0|1.24|3.42|||Log Rank|||||3.42|1.24|<0.004
73833840|NCT00875667|147215975|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.519|TWO_SIDED|95.0|0.62|1.28|||Log Rank|||||1.28|0.62|0.519
73833841|NCT00875667|147215976|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.558|TWO_SIDED|95.0|0.67|1.25|||Log Rank|||||1.25|0.67|0.558
73833842|NCT00412451|147216018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.001||||0.131|TWO_SIDED|95.0|0.001|999.999|||Fisher Exact|||||999.999|0.001|0.131
73833843|NCT00412451|147216018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.562||||0.67|TWO_SIDED|95.0|0.132|2.4|||Fisher Exact|||||2.400|0.132|0.670
73833844|NCT00412451|147216018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.346||||0.372||95.0|0.07|1.703|||Fisher Exact|||||1.703|0.070|0.372
73833845|NCT00923702|147216039|NON_INFERIORITY|To test for non-inferiority of antibody concentrations in different dose groups, log-transformed mean MFIs in linear regression models were used to obtain MFI ratios and their corresponding 95% confidence intervals (CIs). Antibody titres at months 0, 7, 12, 36 and 48 were compared and non-inferiority was inferred when the lower bound of the confidence interval of the ratio of the immunogenicity measures exceeded 0.5.|Risk Ratio (RR)|0.5|||||ONE_SIDED||||||Regression, Linear||The lower bound of the 95% CI ratio of immunogeneicity measures was used instead. No p-values were estimated.|||||
73833846|NCT00923702|147216040|SUPERIORITY||Vaccine efficacy|95.0|||||TWO_SIDED|||||||||||||
73833847|NCT02942407|147216098|NON_INFERIORITY|Due to a lower recruitment rate than anticipated in the early stage of the trial, the sample size was curtailed from 760 to 230 patients. Thus, under the initial protocol assumptions, the study is considered under-powered for the two-sided upper 95% CI on the HR to rule-out the non-inferiority margin of 1.40.|Hazard Ratio (HR)|1.2||||0.321|TWO_SIDED|95.0|0.63|2.3|||Regression, Cox|Cox model was adjusted for prior warfarin status (naive vs experienced) and treatment (apixaban vs warfarin)|Time from randomization to first occurrence of outcome was modeled. If no event, censored at earliest of: most recent date of evaluation of outcome, month 15 target (460 days + randomization date), or end of study date (July 27, 2019).|Exploratory analysis due to failure to reach initial sample size: Non-inferiority (NI) null hypothesis: HR \>= 1.4 (Non-inferiority).||2.3|0.63|0.321
73833848|NCT02942407|147216098|SUPERIORITY|Exploratory analysis due to lack of achieving initial sample size.|Hazard Ratio (HR)|1.2||||0.583|TWO_SIDED|95.0|0.63|2.3||If upper limit of 95% confidence interval \< 1 this would be considered evidence of superiority.|Regression, Cox|Cox model was adjusted for prior warfarin status (naive vs experienced) and treatment (apixaban vs warfarin).|Time from randomization to first occurrence of outcome was modeled. If no event, censored at earliest of: most recent date of evaluation of outcome, month 15 target (460 days + randomization date), or end of study date (July 27, 2019).|||2.3|0.63|0.583
73833849|NCT02942407|147216100|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.74|2.93||No p-value provided as analysis is considered exploratory due to study being under powered.||||Hazard ratios (apixaban vs warfarin) and 95% confidence intervals obtained using Cox model adjusted for prior warfarin status (naive vs experienced) and treatment. Time from randomization to first occurrence of the composite outcome/censoring date modeled. Those that did not experience the outcome are censored at the earliest of the following: 1) most recent date of evaluation of all of the components, 2) month 15 target (460 days + randomization date), and end of study date (July 27, 2019).||2.93|0.74|
73833850|NCT02942407|147216109|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.67|2.17||No p-value provided as analysis is considered exploratory due to study being under powered.||||Hazard ratios (apixaban vs warfarin) and 95% confidence intervals obtained using Cox model adjusted for prior warfarin status (naive vs experienced) and treatment. Time from randomization to first occurrence of the composite outcome/censoring date modeled. Those that did not experience the outcome are censored at the earliest of the following: 1) most recent date of evaluation of all of the components, 2) month 15 target (460 days + randomization date), and end of stud date (July 27, 2019).||2.17|0.67|
73896660|NCT00955201|147326624|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
73896661|NCT00955201|147326624|SUPERIORITY|||||||0.85|||||||ANOVA|||Comparison across groups at baseline||||0.85
73833851|NCT03925220|147216120|SUPERIORITY||Prevalence Ratio (PR)|2.86|||<|0.001|TWO_SIDED|95.0|2.02|4.04||"At 3 months:~Parent-reported frequency of conversations on drinking alcohol"|Generalized estimation|||A sample size of 400 parents and children was calculated to yield 80% power to detect one or more differences between the intervention and control arms, of 45% in talking about alcohol, 20% about marijuana, and 20% about other drugs, using a two-sided Bonferroni-corrected 1.5% level of significance (based on estimates from the pilot trial).||4.04|2.02|<0.001
73833852|NCT03925220|147216120|SUPERIORITY||Prevalence Ratio [PR]|2.4|||<|0.001|TWO_SIDED|95.0|1.67|3.45||"At 3 months:~Parent-reported frequency of conversations on using e-cigarettes or vaping"|Generalized estimation|||||3.45|1.67|<0.001
73833853|NCT03925220|147216120|SUPERIORITY||Prevalence Ratio [PR]|2.36|||<|0.001|TWO_SIDED|95.0|1.62|3.43||"At 3 months:~Parent-reported frequency of conversations on using marijuana"|Generalized estimation|||||3.43|1.62|<0.001
73833854|NCT03925220|147216120|SUPERIORITY||Prevalence Ratio [PR]|3.45|||<|0.001|TWO_SIDED|95.0|2.34|5.08||"At 3 months:~Parent-reported frequency of conversations on smoking cigarettes"|Generalized estimation|||||5.08|2.34|<0.001
73833855|NCT03925220|147216120|SUPERIORITY||Prevalence Ratio [PR]|2.47|||<|0.001|TWO_SIDED|95.0|1.58|3.86||"At 3 months:~Parent-reported frequency of conversations on using other drugs"|Generalized estimation|||||3.86|1.58|<0.001
73833856|NCT03925220|147216120|SUPERIORITY||Prevalence Ratio [PR]|1.45||||0.04|TWO_SIDED|95.0|1.02|2.06||"At 18 months:~Parent-reported frequency of conversations on drinking alcohol"|Generalized estimation|||||2.06|1.02|0.04
73833857|NCT03925220|147216121|SUPERIORITY||Prevalence Ratio (PR)|1.31|||<|0.001|TWO_SIDED|95.0|1.18|1.45||"At 3 months:~Parent-reported have warned your child about the dangers of drinking alcohol and using drugs"|Generalized estimation|||||1.45|1.18|<0.001
73833858|NCT03925220|147216121|SUPERIORITY||Prevalence Ratio [PR]|1.55|||<|0.001|TWO_SIDED|95.0|1.32|1.83||"At 3 months:~Parent-reported 'have talked to your child about how to handle offers of alcoholic drinks and drugs'"|Generalized estimation|||||1.83|1.32|<0.001
73833859|NCT03925220|147216121|SUPERIORITY||Prevalence Ratio [PR]|2.13|||<|0.001|TWO_SIDED|95.0|1.73|2.63||"At 3 months:~Parent-reported 'have given your child rules to obey about drinking alcohol and using drugs'"|Generalized estimation|||||2.63|1.73|<0.001
73833860|NCT03925220|147216121|SUPERIORITY||Prevalence Ratio [PR]|1.67||||0.001|TWO_SIDED|95.0|1.25|2.25||"At 3 months:~Parent-reported 'have lectured or given your child a speech about drinking alcohol and using drugs'"|Generalized estimation|||||2.25|1.25|0.001
73833861|NCT03925220|147216121|SUPERIORITY||Prevalence Ratio [PR]|1.51|||<|0.001|TWO_SIDED|95.0|1.21|1.9||"At 3 months:~Parent-reported 'have made a comment to your child about how drinking alcohol and using drugs is bad if a character on TV is drinking or drunk'"|Generalized estimation|||||1.90|1.21|<0.001
73833862|NCT03925220|147216121|SUPERIORITY||Prevalence Ratio [PR]|1.25||||0.008|TWO_SIDED|95.0|1.06|1.47||"At 3 months:~Parent-reported 'have told your child stories of people who drink alcohol, have been drunk, or use drugs'"|Generalized estimation|||||1.47|1.06|0.008
73833863|NCT03925220|147216121|SUPERIORITY||Prevalence Ratio [PR]|1.65|||<|0.001|TWO_SIDED|95.0|1.29|2.1||"At 3 months:~Parent-reported 'have told your child you would be disappointed in her/him if they were to drink alcohol or use drugs'"|Generalized estimation|||||2.10|1.29|<0.001
73833864|NCT03925220|147216121|SUPERIORITY||Prevalence Ratio [PR]|1.64|||<|0.001|TWO_SIDED|95.0|1.24|2.15||"At 3 months:~Parent-reported 'have shown your child information on the web, TV, or in the news about the dangers of drinking alcohol and using drugs'"|Generalized estimation|||||2.15|1.24|<0.001
73833865|NCT03925220|147216121|SUPERIORITY||Prevalence Ratio [PR]|1.65|||<|0.001|TWO_SIDED|95.0|1.4|1.93||"At 3 months:~Parent-reported 'have asked your child about their thoughts and opinions about drinking alcohol and using drugs'"|Generalized estimation|||||1.93|1.40|<0.001
73833866|NCT03925220|147216121|SUPERIORITY||Prevalence Ratio [PR]|1.4||||0.003|TWO_SIDED|95.0|1.12|1.74||"At 18 months:~Parent-reported 'have given your child rules to obey about drinking alcohol and using drugs'"|Generalized estimation|||||1.74|1.12|0.003
73833867|NCT03925220|147216121|SUPERIORITY||Prevalence Ratio [PR]|1.38||||0.01|TWO_SIDED|95.0|1.06|1.78||"At 18 months:~Parent-reported 'have made a comment to your child about how drinking alcohol and using drugs is bad if a character on TV is drinking or drunk'"|Generalized estimation|||||1.78|1.06|0.01
73833868|NCT05561140|147216137|SUPERIORITY||Difference in percentage|-0.3|||=|1|TWO_SIDED|95.0|-10.9|10.2|||Cochran-Mantel-Haenszel|||||10.2|-10.9|=1.0000
73833869|NCT05561140|147216139|SUPERIORITY||Least Square (LS) Mean Difference|-8.2|||=|0.0297|TWO_SIDED|95.0|-15.6|-0.8|||Mixed Models Analysis|||The mixed model for repeated measures (MMRM) model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for stratification factors.||-0.8|-15.6|=0.0297
73833870|NCT05561140|147216140|SUPERIORITY||Difference in percentage|-8.1|||=|0.3456|TWO_SIDED|95.0|-26.9|10.7|||Cochran-Mantel-Haenszel|||||10.7|-26.9|=0.3456
73833871|NCT01944774|147216141|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.291||||0.133|TWO_SIDED|95.0|0.058|1.457||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.457|0.058|0.133
73833872|NCT01944774|147216141|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.492||||0.423|TWO_SIDED|95.0|0.087|2.788||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.788|0.087|0.423
73833873|NCT01944774|147216142|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.276||||0.118|TWO_SIDED|95.0|0.055|1.385||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.385|0.055|0.118
73896662|NCT00955201|147326624|SUPERIORITY|||||||0.98|||||||ANOVA|||Comparison across groups at 12-wks||||0.98
73896663|NCT00955201|147326624|SUPERIORITY|||||||0.68|||||||ANOVA|||Comparison across groups at 24-wks||||0.68
73833874|NCT01944774|147216142|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.644||||0.636|TWO_SIDED|95.0|0.104|3.999||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||3.999|0.104|0.636
73833875|NCT01944774|147216143|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.517||||0.456|TWO_SIDED|95.0|0.091|2.93||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.930|0.091|0.456
73833876|NCT01944774|147216143|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.508||||0.445|TWO_SIDED|95.0|0.09|2.883||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.883|0.090|0.445
73833877|NCT01944774|147216144|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.518||||0.458|TWO_SIDED|95.0|0.091|2.941||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.941|0.091|0.458
73833878|NCT01944774|147216144|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.667||||0.664|TWO_SIDED|95.0|0.107|4.144||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.144|0.107|0.664
73833879|NCT01944774|147216145|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.959|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.959
73833880|NCT01944774|147216145|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.961|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.961
73833881|NCT01944774|147216146|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.96|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.960
73833882|NCT01944774|147216146|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
73833883|NCT01944774|147216147|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.95|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.950
73833884|NCT01944774|147216147|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
73833885|NCT01944774|147216148|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.949|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.949
73833886|NCT01944774|147216148|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
73833887|NCT01944774|147216149|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.438||||0.491|TWO_SIDED|95.0|0.042|4.609||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.609|0.042|0.491
73833888|NCT01944774|147216149|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.531||||0.619|TWO_SIDED|95.0|0.044|6.444||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.444|0.044|0.619
73833889|NCT01944774|147216150|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.444||||0.501|TWO_SIDED|95.0|0.042|4.708||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.708|0.042|0.501
73833890|NCT01944774|147216150|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
73833891|NCT01944774|147216151|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.733||||0.807|TWO_SIDED|95.0|0.061|8.832||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||8.832|0.061|0.807
73833892|NCT01944774|147216151|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
73833893|NCT01944774|147216152|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7||||0.779|TWO_SIDED|95.0|0.058|8.445||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||8.445|0.058|0.779
73833894|NCT01944774|147216152|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
73833895|NCT01835756|147216160|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED||||||t-test, 2 sided|||||||<0.00001
73833896|NCT01835756|147216161|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
73833897|NCT05073315|147216193|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Ratio Geometric Least Square Mean (GMR)|1.0516|||||TWO_SIDED|90.0|0.901|1.2273||||||||1.2273|0.9010|
73833898|NCT05073315|147216194|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Least Square Mean Ratio|1.0044|||||TWO_SIDED|90.0|0.8717|1.1574||||||||1.1574|0.8717|
73833899|NCT05073315|147216197|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Mean Difference (Final Values)|-2.47|||||TWO_SIDED|90.0|-5.23|0.29||||||||0.29|-5.23|
73833900|NCT01529268|147216204|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.8|2.1|||Cochran-Mantel-Haenszel|||||2.1|0.8|0.34
73833901|NCT01529268|147216205|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.9|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.90
73833902|NCT01529268|147216206|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.7||||0.15|TWO_SIDED|95.0|0.5|1.1|||Cochran-Mantel-Haenszel|||Steatosis: patients with improvement||1.1|0.5|0.15
73833903|NCT01529268|147216207|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.59|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Steatosis: change in score||0.4|-0.2|0.59
73833904|NCT01529268|147216208|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.8||||0.03|TWO_SIDED|95.0|1.1|2.9|||Cochran-Mantel-Haenszel|||||2.9|1.1|0.03
73833905|NCT01529268|147216209|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.06|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.06
73833906|NCT01529268|147216210|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.8||||0.29|TWO_SIDED|95.0|0.4|1.3|||Cochran-Mantel-Haenszel|||||1.3|0.4|0.29
73833907|NCT01529268|147216211|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.15|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|||||0.3|-0.1|0.15
73833908|NCT01529268|147216212|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.2||||0.57|TWO_SIDED|95.0|0.6|2.3|||Cochran-Mantel-Haenszel|||||2.3|0.6|0.57
73833909|NCT01529268|147216213|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.76|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.76
73833910|NCT01529268|147216214|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.6|1.6|||Cochran-Mantel-Haenszel|||||1.6|0.6|0.98
73833911|NCT01529268|147216215|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.24|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.24
73833912|NCT01529268|147216216|NON_INFERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|2.7||||0.29|TWO_SIDED|95.0|0.4|18.3|||Cochran-Mantel-Haenszel|Stratified by clinic and weight group||||18.3|0.4|0.29
73833913|NCT01529268|147216217|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing change from baseline to 52 weeks in serum alanine aminotransferase on treatment group and baseline value of serum alanine aminotransferase.|Adjusted difference in mean changes|-24.0||||0.02|TWO_SIDED|95.0|-44.0|-4.0|||ANCOVA|Adjusted for baseline serum alanine aminotransferase||Adjusted difference in mean changes in serum alanine aminotransferase (ALT). The change in ALT is adjusted for the baseline ALT value; therefore, the adjusted difference in mean changes is not equal to the net change.||-4|-44|0.02
73833914|NCT01529268|147216217|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in serum aspartate aminotransferase on treatment group and baseline value of serum aspartate aminotransferase.|Mean Difference (Net)|-15.0||||0.008|TWO_SIDED|95.0|-26.0|-4.0|||ANCOVA|Adjusted for baseline serum aspartate aminotransferase.||Adjusted difference in mean changes in serum aspartate aminotransferase (AST). The change in AST is adjusted for the baseline AST value; therefore, the adjusted difference in mean changes is not equal to the net change.||-4|-26|0.008
73833915|NCT01529268|147216217|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in gamma-glutamyl transpeptidase on treatment group and baseline value of gamma-glutamyl transpeptidase.|Mean Difference (Net)|-7.0||||0.02|TWO_SIDED|95.0|-13.0|-1.0|||ANCOVA|Adjusted for baseline gamma-glutamyl transpeptidase||Adjusted difference in mean changes in serum gamma-glutamyl transpeptidase (GGT). The change in GGT is adjusted for the baseline GGTvalue; therefore, the adjusted difference in mean changes is not equal to the net change.||-1|-13|0.02
73833916|NCT01529268|147216218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-value and adjusted difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in weight (kg) on treatment group and baseline weight (kg).|Adjusted difference in mean changes|-1.5||||0.25|TWO_SIDED|95.0|-4.1|1.1|||ANCOVA|Adjusted for baseline weight (kg).||Adjusted difference in mean changes in weight (kg). The change in weight is adjusted for the baseline weight value; therefore, the adjusted difference in mean changes is not equal to the net change.||1.1|-4.1|0.25
73896664|NCT00955201|147326625|SUPERIORITY|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.91
73833917|NCT01529268|147216219|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Adjusted difference in mean changes|-0.3||||0.42|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA|Adjusted for baseline BMI (kg/m2)||Adjusted difference in mean changes in body mass index (BMI). The change in BMI is adjusted for the baseline BMI value; therefore, the adjusted difference in mean changes is not equal to the net change.||0.5|-1.1|0.42
73833918|NCT01529268|147216220|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Mean Difference (Net)|-0.1||||0.11|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|||||0.0|-0.1|0.11
73833919|NCT01529268|147216221|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in waist circumference on treatment group and baseline value of waist circumference.|Adjusted difference in mean changes|0.2||||0.89|TWO_SIDED|95.0|-2.3|2.6|||ANCOVA|Adjusted for baseline waist circumference (cm)||Adjusted difference in mean changes in waist circumference (cm). The change in waist circumference is adjusted for the baseline waist circumference value; therefore, the adjusted difference in mean changes is not equal to the net change.||2.6|-2.3|0.89
73833920|NCT01529268|147216222|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting serum glucose on treatment group and baseline fasting serum glucose value.|Adjusted difference in mean changes|-4.0||||0.24|TWO_SIDED|95.0|-11.0|3.0|||ANCOVA|Adjusted for baseline serum glucose value.||Adjusted difference in mean changes in fasting serum glucose. The change in fasting serum glucose is adjusted for the baseline fasting serum glucose value; therefore, the adjusted difference in mean changes is not equal to the net change.||3|-11|0.24
73833921|NCT01529268|147216223|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting insulin on treatment group and baseline fasting insulin.|Adjusted difference in mean changes|-6.0||||0.34|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA|Adjusted for baseline fasting insulin.||Adjusted difference in mean changes in fasting insulin. The change in fasting insulin is adjusted for the baseline fasting insulin value; therefore, the adjusted difference in mean changes is not equal to the net change.||6|-18|0.34
73833922|NCT01529268|147216224|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in HOMA-IR on treatment group and baseline HOMA-IR value.|Adjusted difference in mean changes|-2.6||||0.15|TWO_SIDED|95.0|-6.2|1.0|||ANCOVA|Adjusted for baseline HOMA-IR.||Adjusted difference in mean changes in HOMA-IR. The change in HOMA-IR is adjusted for the baseline HOMA-IR value; therefore, the adjusted difference in mean changes is not equal to the net change.||1.0|-6.2|0.15
73833923|NCT01529268|147216225|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in systolic blood pressure on treatment group and baseline systolic blood pressure value.|Adjusted difference in mean changes|1.0||||0.71|TWO_SIDED|95.0|-3.0|4.0|||ANCOVA|Adjusted for baseline systolic blood pressure.||Adjusted difference in mean changes in systolic blood pressure. The change in systolic blood pressure is adjusted for the baseline systolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.||4|-3|0.71
73833924|NCT01529268|147216226|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in diastolic blood pressure on treatment group and baseline diastolic blood pressure value.|Adjusted difference in mean changes|-1.0||||0.31|TWO_SIDED|95.0|-4.0|1.0|||ANCOVA|Adjusted for baseline diastolic blood pressure.||Adjusted difference in mean changes in diastolic blood pressure. The change in diastolic blood pressure is adjusted for the baseline diastolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.||1|-4|0.31
73833925|NCT01529268|147216227|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in self-reported Physical Health summary score on treatment group and baseline value of the Physical Health summary score.|Adjusted difference in mean changes|-1.0||||0.77|TWO_SIDED|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline self-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in self-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Physical Health summary score is adjusted for the baseline Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||3|-5|0.77
73833926|NCT01529268|147216227|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in Pyschosocial Health summary score on treatment group and baseline Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.64|TWO_SIDED|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline Psychosocial Health summary score.||Adjusted difference in mean changes from baseline in self-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Psychosocial Health summary score is adjusted for the baseline Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||3|-5|0.64
73833927|NCT01529268|147216227|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Physical Health summary score on treatment group and baseline value of the parent/guardian-reported Physical Health summary score.|Adjusted difference in mean changes|-2.0||||0.58|TWO_SIDED|95.0|-9.0|5.0|||ANCOVA|Adjusted for baseline parent/guardian-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in parent/guardian-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Physical Health summary score is adjusted for the baseline parent/guardian-reported Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||5|-9|0.58
73896665|NCT00955201|147326625|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
73833928|NCT01529268|147216227|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Psychosocial Health summary score on treatment group and baseline value of the parent/guardian-reported Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.85|TWO_SIDED|95.0|-6.0|5.0|||ANCOVA|||Adjusted difference in mean changes from baseline in parent/guardian-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Psychosocial Health summary score is adjusted for the baseline parent/guardian-reported Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||5|-6|0.85
73833929|NCT01529268|147216228|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.11|TWO_SIDED||||||ANCOVA|||||||0.11
73833930|NCT03491917|147216239|NON_INFERIORITY|Non-inferiority margin is delta = 0.05.|||||<|0.01||||||The average difference in AUC was 0.023 (two-sided 95% CI: -0.012, 0.059; non-inferiority p \< 0.01 for non-inferiority margin delta = -0.05).|t-test, 2 sided|df: 417.0 for FFDM, 424.6 for DBT plus S-View, and (1, 18.9) for the difference.||The primary endpoint for this study was a non-inferior per-subject average area under the receiver operating characteristic (ROC) curve (AUC) requiring correct lesion localization for DBT (digital breast tomosynthesis) plus S-View (synthesized view) versus FFDM (full field digital mammography). AUCs for each reader were estimated in each review condition based on per-subject probability of malignancy (POM) scores requiring correct lesion localization.||||<0.01
73833931|NCT01068912|147216246|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||A step-down approach was applied to the primary analysis, with the higher dose of favipiravir first tested against placebo.|Gehan-Wilcoxon|||Time required from first study drug administration to alleviation of the 6 primary influenza symptoms and fever. The primary influenza symptoms included cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue. Symptoms were considered alleviated when all were decreased to ≤1 and decrease persisted unchanged ≥ 21.5 hours. Fever was considered alleviated when maintained at \< 38.0°C (age 20 to \< 65 years) or \< 37.8°C (age ≥ 65 years) ≥ 21.5 hours.||||.05
73833932|NCT00294398|147216247|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
73833933|NCT05537571|147216261|SUPERIORITY||Mean Difference (Final Values)|-82.8|||<|0.0001|TWO_SIDED|95.0|-88.19|-77.39|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.39|-88.19|<0.0001
73833934|NCT05537571|147216261|SUPERIORITY||Mean Difference (Final Values)|-81.3|||<|0.0001|TWO_SIDED|95.0|-86.68|-76.0|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-76.0|-86.68|<0.0001
73833935|NCT05537571|147216261|SUPERIORITY||Mean Difference (Final Values)|-85.6|||<|0.0001|TWO_SIDED|95.0|-90.88|-80.26|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-80.26|-90.88|<0.0001
73833936|NCT05537571|147216262|SUPERIORITY||Mean Difference (Final Values)|-83.1|||<|0.0001|TWO_SIDED|95.0|-88.7|-77.57|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.57|-88.7|<0.0001
73833937|NCT05537571|147216262|SUPERIORITY||Mean Difference (Final Values)|-78.7|||<|0.0001|TWO_SIDED|95.0|-84.18|-73.17|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-73.17|-84.18|<0.0001
73833938|NCT05537571|147216262|SUPERIORITY||Mean Difference (Final Values)|-83.0|||<|0.0001|TWO_SIDED|95.0|-88.43|-77.49|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.49|-88.43|<0.0001
73833939|NCT05537571|147216263|SUPERIORITY||Mean Difference (Final Values)|-79.2|||<|0.0001|TWO_SIDED|95.0|-85.25|-73.1|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-73.1|-85.25|<0.0001
73833940|NCT05537571|147216263|SUPERIORITY||Mean Difference (Final Values)|-71.8|||<|0.0001|TWO_SIDED|95.0|-77.81|-65.8|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-65.8|-77.81|<0.0001
73833941|NCT05537571|147216263|SUPERIORITY||Mean Difference (Final Values)|-77.1|||<|0.0001|TWO_SIDED|95.0|-83.09|-71.15|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-71.15|-83.09|<0.0001
73833942|NCT05537571|147216264|SUPERIORITY||Mean Difference (Final Values)|-13.3|||<|0.0001|TWO_SIDED|95.0|-18.55|-8.09|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.09|-18.55|<0.0001
73833943|NCT05537571|147216264|SUPERIORITY||Mean Difference (Final Values)|-9.9|||=|0.0002|TWO_SIDED|95.0|-15.02|-4.68|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-4.68|-15.02|=0.0002
73833944|NCT05537571|147216264|SUPERIORITY||Mean Difference (Final Values)|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.1|-9.82|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-9.82|-20.1|<0.0001
73833945|NCT05537571|147216265|SUPERIORITY||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.62|-7.08|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.08|-17.62|<0.0001
73833946|NCT05537571|147216265|SUPERIORITY||Mean Difference (Final Values)|-8.6|||=|0.0013|TWO_SIDED|95.0|-13.85|-3.44|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-3.44|-13.85|=0.0013
73833947|NCT05537571|147216265|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-19.2|-8.84|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.84|-19.2|<0.0001
73896666|NCT00955201|147326625|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.94
73833948|NCT05537571|147216266|SUPERIORITY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.81|-5.73|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-5.73|-16.81|<0.0001
73833949|NCT05537571|147216266|SUPERIORITY||Mean Difference (Final Values)|-7.2|||=|0.0106|TWO_SIDED|95.0|-12.64|-1.69|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-1.69|-12.64|=0.0106
73833950|NCT05537571|147216266|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.0001|TWO_SIDED|95.0|-18.04|-7.15|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.15|-18.04|<0.0001
73833951|NCT05537571|147216267|SUPERIORITY||Mean Difference (Final Values)|-31.9|||=|0.0051|TWO_SIDED|95.0|-54.07|-9.72|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-9.72|-54.07|=0.0051
73833952|NCT05537571|147216267|SUPERIORITY||Mean Difference (Final Values)|-29.7|||=|0.0081|TWO_SIDED|95.0|-51.62|-7.81|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.81|-51.62|=0.0081
73833953|NCT05537571|147216267|SUPERIORITY||Mean Difference (Final Values)|-25.1|||=|0.0241|TWO_SIDED|95.0|-46.89|-3.33|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-3.33|-46.89|=0.0241
73833954|NCT05537571|147216268|SUPERIORITY||Mean Difference (Final Values)|-29.8|||=|0.0023|TWO_SIDED|95.0|-48.86|-10.76|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-10.76|-48.86|=0.0023
73833955|NCT05537571|147216268|SUPERIORITY||Mean Difference (Final Values)|-27.4|||=|0.0046|TWO_SIDED|95.0|-46.23|-8.58|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.58|-46.23|=0.0046
73833956|NCT05537571|147216268|SUPERIORITY||Mean Difference (Final Values)|-26.0|||=|0.0068|TWO_SIDED|95.0|-44.67|-7.24|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.24|-44.67|=0.0068
73833957|NCT05537571|147216269|SUPERIORITY||Mean Difference (Final Values)|-28.7|||=|0.0057|TWO_SIDED|95.0|-48.91|-8.46|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.46|-48.91|=0.0057
73833958|NCT05537571|147216269|SUPERIORITY||Mean Difference (Final Values)|-26.1|||||TWO_SIDED|95.0|-46.13|-6.16||||||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-6.16|-46.13|
73833959|NCT05537571|147216269|SUPERIORITY||Mean Difference (Final Values)|-24.1||||0.0179|TWO_SIDED|95.0|-43.93|-4.2|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-4.2|-43.93|0.0179
73833960|NCT05494632|147216270|SUPERIORITY||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|||||the threshold for statistical significance was \<=0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
73833961|NCT01590875|147216367|EQUIVALENCE|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||no relevant statistical analysis|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose||||<0.01
73833962|NCT01590875|147216368|EQUIVALENCE|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||kappa statistic|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose||||< 0.01
73833963|NCT01214720|147216372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.61|0.86|||Log Rank|||||0.86|0.61|0.0002
73833964|NCT01214720|147216373|SUPERIORITY_OR_OTHER||Difference in Response Rates|3.62||||0.3621|TWO_SIDED|95.0|-4.3|11.6|||Chi-squared|Approximate 95% confidence interval (CI) for difference of two rates using Hauck-Anderson method.||||11.6|-4.3|0.3621
73833965|NCT01214720|147216374|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2087||95.0|0.74|1.07|||Log Rank|||||1.07|0.74|0.2087
73833966|NCT02347787|147216376|SUPERIORITY|||||||0.3|||||||Regression, Linear|||Determination of targeted sample size was based on detecting a between-arm difference in mean change in SF-12 Physical Component Summary of 3 points, which is the minimal clinically significant difference for this instrument. To achieve at least 80% power with a type I error rate of 5%, we required 444 total participants. To account for 25% attrition, we aimed to accrue 592 participants.||||0.30
73833967|NCT02347787|147216377|SUPERIORITY||Risk Difference (RD)|-0.2||||0.21|TWO_SIDED|95.0|-1.3|0.9|||Regression, Linear|||||0.9|-1.3|0.21
73833968|NCT02347787|147216378|SUPERIORITY||Risk Difference (RD)|-0.2||||0.21|TWO_SIDED|95.0|-0.7|0.4|||Regression, Linear|||||0.4|-0.7|0.21
73833969|NCT02347787|147216379|SUPERIORITY||Risk Difference (RD)|-0.5||||0.21|TWO_SIDED|95.0|-2.2|1.2|||Regression, Linear|||||1.2|-2.2|0.21
73833970|NCT02347787|147216380|SUPERIORITY||Risk Difference (RD)|-6.3||||0.21|TWO_SIDED|95.0|-14.3|1.8|||Regression, Linear|||||1.8|-14.3|0.21
73833971|NCT02347787|147216381|SUPERIORITY|||||||0.41|||||||Regression, Linear|||||||0.41
73833972|NCT02347787|147216382|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73833973|NCT02347787|147216383|SUPERIORITY||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||||1.5|0.6|0.98
73833974|NCT02347787|147216385|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
73833975|NCT02347787|147216386|SUPERIORITY|||||||0.02|||||||Regression, Logistic|||||||0.02
73833976|NCT02347787|147216387|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||||||0.04
73833977|NCT02347787|147216389|SUPERIORITY|||||||0.09|||||||Regression, Linear|||||||0.09
73833978|NCT02347787|147216390|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
73833979|NCT01059851|147216391|NON_INFERIORITY_OR_EQUIVALENCE|"AUC(0-∞) GMR = AUC(0-∞) GM for Severe Renal Impairment Participants ÷ AUC(0-∞) GM for Healthy Participants.~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the 90% CI for the AUC(0-∞) GMR was contained within the interval \[0.50, 2.00\], then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is greater than 0.50 and no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|0.93|1.6|||ANCOVA|||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single oral dose would be similar between participants with renal impairment and healthy matched control participants."||1.60|0.93|
73833980|NCT00223821|147216395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|STANDARD_ERROR_OF_MEAN|7.65||0.16|TWO_SIDED|95.0|-5.13|25.54|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.||The effectiveness of each intervention was calculated by comparing the weekly frequency of incontinent episodes (derived from seven-day bladder diaries) during baseline to that in the immediate post-intervention period (week 8). The primary analysis was based on intent-to-treat, in which post-treatment frequency of incontinence for non-completers was derived from the most recent week of diaries.||25.54|-5.13|.16
73833981|NCT00223821|147216396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|8.71||0.37|TWO_SIDED|95.0|-10.73|24.33|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.||||24.33|-10.73|.37
73833982|NCT01039675|147216397|NON_INFERIORITY_OR_EQUIVALENCE|UMEC/VI will be declared non-inferior to placebo in terms of weighted mean pulse rate if the upper limit of the 95% confidence interval around the estimated treatment difference for weighted mean pulse rate is less than the non-inferiority margin of +10bpm.|Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-5.5|4.5|||||Estimated from repeated measures analysis of covariance.|||4.5|-5.5|
73833983|NCT00138294|147216406|OTHER||Incidence Rate Ratio|0.89|||||TWO_SIDED|95.0|0.87|0.91||||||Overall Effectiveness against MAARI during the Epidemic Period (2007-2008)||0.91|0.87|
73833984|NCT00138294|147216407|OTHER||Incidence Rate Ratio|0.69|||||TWO_SIDED|95.0|0.67|0.71||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)||0.71|0.67|
73833985|NCT00138294|147216408|OTHER||Incidence Rate Ratio|0.75|||||TWO_SIDED|95.0|0.73|0.76||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)||0.76|0.73|
73833986|NCT01137812|147216420|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and sitagliptin of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.025, it was estimated that 234 patients per group would provide approximately 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with sitagliptin.|Least-Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.064|<|0.05|TWO_SIDED|95.0|-0.5|-0.25|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to sitagliptin at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus sitagliptin\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to sitagliptin would be concluded.||-0.250|-0.500|<0.05
73833987|NCT01137812|147216421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.3|2.48|||Regression, Logistic|||||2.48|1.30|
73833988|NCT01137812|147216422|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-29.89|-18.24|||ANCOVA|||||-18.24|-29.89|<0.001
73833989|NCT01137812|147216423|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.3|-2.2|||ANCOVA|||||-2.2|-3.3|<0.001
73833990|NCT01137812|147216424|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.91|STANDARD_ERROR_OF_MEAN|0.883|<|0.001|TWO_SIDED|95.0|-7.642|-4.175|||ANCOVA|||||-4.175|-7.642|<0.001
73833991|NCT01137812|147216425|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|3.9||0.554|TWO_SIDED|95.0|-9.8|5.3|||ANCOVA|||||5.3|-9.8|0.554
73833992|NCT01137812|147216426|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|4.6|9.3|||ANCOVA|||||9.3|4.6|<0.001
73833993|NCT04621760|147216427|SUPERIORITY|||||||0.51||||||a priori threshold for statistical significance: 0.05|Fisher Exact|||||||0.51
73833994|NCT04621760|147216428|SUPERIORITY|||||||0.62||||||threshold for significance: 0.05|Fisher Exact|one sided Fisher's exct test, given small cell sizes.||||||0.62
73833995|NCT04621760|147216429|SUPERIORITY|||||||0.207||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small sample size||||||0.207
73833996|NCT04621760|147216430|SUPERIORITY|||||||0.496||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small cell size||||||0.496
73833997|NCT04621760|147216431|SUPERIORITY|||||||0.02||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion correctly identifying PrEP is a daily pill to prevent HIV"||||0.02
73833998|NCT04621760|147216431|SUPERIORITY|||||||0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion correctly responding to prompt: PrEP is for all adults"||||0.01
73833999|NCT04621760|147216431|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified: PrEP will not work if taken once a week"||||<0.01
73834000|NCT04621760|147216431|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test of proportion who correctly identified PrEP does not prevent STDs other than HIV"||||<0.01
73834001|NCT04621760|147216431|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified, PrEP side effects do not last forever"||||<0.01
73834002|NCT04621760|147216431|SUPERIORITY|||||||0.03||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified, A baby could be norm to HIV discordant parents without transmitting HIV"||||0.03
73834003|NCT04621760|147216431|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified There is medication you can take after sex to prevent HIV"||||<0.01
73834004|NCT04621760|147216431|SUPERIORITY|||||||0.29||||||a priori threshold for significance: 0.05|Chi-squared|||"Test for proportion who correctly identified PrEP efficacy is \> 95%"||||0.29
73834005|NCT04621760|147216432|SUPERIORITY|||||||0.04||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.04
73834006|NCT04621760|147216433|SUPERIORITY|||||||0.02||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.02
73834007|NCT04621760|147216434|SUPERIORITY|||||||0.05||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.05
73834008|NCT04621760|147216435|SUPERIORITY|||||||0.03||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.03
73834009|NCT04621760|147216436|SUPERIORITY|||||||0.07||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.07
73834010|NCT04621760|147216437|SUPERIORITY|||||||0.1||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.10
73834011|NCT04621760|147216438|SUPERIORITY|||||||0.22||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong negative skew of responses, transformed into a binary variable comparing those with highest possible score versus higher score. Data then tested through tests of proportions.||||0.22
73834012|NCT04621760|147216439|SUPERIORITY|||||||0.51||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small cell size||||||0.51
73834013|NCT04621760|147216440|SUPERIORITY|||||||0.9||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use PrEP||||0.90
73834014|NCT04621760|147216440|SUPERIORITY|||||||0.75||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use abstinence||||0.75
73834015|NCT04621760|147216440|SUPERIORITY|||||||0.32||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use PEP||||0.32
73834016|NCT04621760|147216440|SUPERIORITY|||||||0.4||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use HIV testing||||0.40
73834017|NCT04621760|147216440|SUPERIORITY|||||||0.34||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use STD testing||||0.34
73834018|NCT04621760|147216440|SUPERIORITY|||||||0.1||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use Treatment as Prevention||||0.10
73834019|NCT04621760|147216441|SUPERIORITY|||||||0.01||||||a priori threshold for significance: 0.05|Chi-squared|||||||0.01
73834020|NCT04621760|147216442|SUPERIORITY|||||||0.26||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt The information was easy to understand"||||0.26
73834021|NCT04621760|147216442|SUPERIORITY|||||||0.26||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt: I got all of the information I needed"||||0.26
73834022|NCT04621760|147216442|SUPERIORITY|||||||0.59||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.59
73834023|NCT04621760|147216442|SUPERIORITY|||||||0.17||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt: The information felt useful to me"||||0.17
73834024|NCT04621760|147216443|SUPERIORITY|||||||0.74|||||||Chi-squared|||"Testing proportion of acceptability of abstinence method (proportion that responded great for me)"||||0.74
73834025|NCT04621760|147216443|SUPERIORITY|||||||0.59|||||||Chi-squared|||"Testing proportion of acceptability of condoms method (proportion that responded great for me)"||||0.59
73834026|NCT04621760|147216443|SUPERIORITY|||||||0.66|||||||Chi-squared|||"Testing proportion of acceptability of PEP method (proportion that responded great for me)"||||0.66
73834027|NCT04621760|147216443|SUPERIORITY|||||||0.49|||||||Chi-squared|||"Testing proportion of acceptability of PrEP method (proportion that responded great for me)"||||0.49
73834028|NCT04621760|147216443|SUPERIORITY|||||||0.94|||||||Chi-squared|||"Testing proportion of acceptability of HIV testing method (proportion that responded great for me)"||||0.94
73834029|NCT04621760|147216443|SUPERIORITY|||||||0.95|||||||Chi-squared|||"Testing proportion of acceptability of STD testing method (proportion that responded great for me)"||||0.95
73834030|NCT04621760|147216443|SUPERIORITY|||||||0.39|||||||Chi-squared|||"Testing proportion of acceptability of Treatment as prevention method (proportion that responded great for me)"||||0.39
73834031|NCT04621760|147216449|SUPERIORITY|||||||0.13||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.13
73834032|NCT04621760|147216450|SUPERIORITY|||||||0.08||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.08
73834033|NCT02421211|147216451|SUPERIORITY_OR_OTHER||LS means ratio|4.7|||||TWO_SIDED|90.0|3.4|6.5||||||||6.5|3.4|
73834034|NCT02421211|147216452|SUPERIORITY_OR_OTHER||LS means ratio|2.3|||||TWO_SIDED|90.0|2.0|2.8||||||||2.8|2.0|
73834035|NCT02421211|147216453|SUPERIORITY_OR_OTHER||LS means ratio|3.1|||||TWO_SIDED|90.0|2.4|3.8||||||||3.8|2.4|
73834036|NCT02421211|147216454|SUPERIORITY_OR_OTHER||LS means ratio|1.7|||||TWO_SIDED|90.0|1.5|2.0||||||||2.0|1.5|
73834037|NCT02421211|147216455|SUPERIORITY_OR_OTHER||LS means ratio|1.6|||||TWO_SIDED|90.0|1.4|1.9||||||||1.9|1.4|
73834038|NCT02421211|147216456|SUPERIORITY_OR_OTHER||LS means ratio|1.7|||||TWO_SIDED|90.0|1.6|2.0||||||||2.0|1.6|
73896667|NCT00955201|147326625|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.93
73896668|NCT00955201|147326625|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at baseline||||0.38
73834039|NCT04602000|147216475|SUPERIORITY||Difference estimated using CMH weights|-8.0|||<|0.0001|TWO_SIDED|95.0|-11.7|-4.5|||Cochran-Mantel-Haenszel|P-value was calculated using CMH test stratified by age (≥60 vs. \<60 years), baseline comorbidities (Yes vs. No) and region (US vs. EU vs. Other)|The 95% stratified Newcombe CI with CMH weights was presented.|||-4.5|-11.7|<0.0001
73834040|NCT00471354|147216492|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||Spearman Partial Rank Order Correlation|||||||0.293
73834041|NCT00471354|147216493|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||P-value for Correlation with Language Scores|Spearman Partial Rank Order Correlation|||||||0.276
73834042|NCT00471354|147216493|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value for Correlation with Math Scores.|Spearman Partial Rank Order Correlation|||||||0.110
73834043|NCT00471354|147216493|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value for Correlation with Science Scores.|Spearman Partial Rank Order Correlation|||||||0.464
73834044|NCT00471354|147216494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Language Scores.|Paired t-test|||||||<0.001
73834045|NCT00471354|147216494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Math Scores.|Paired t-test|||||||<0.001
73834046|NCT00471354|147216494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Science Scores.|Paired t-test|||||||<0.001
73834047|NCT00471354|147216494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Total Scores.|Paired t-test|||||||<0.001
73834048|NCT00471354|147216495|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
73834049|NCT00471354|147216496|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
73834050|NCT00471354|147216498|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
73834051|NCT01692756|147216578|SUPERIORITY|||||||0.33|||||||Kruskal-Wallis|||||||0.33
73834052|NCT01692756|147216579|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
73834053|NCT01692756|147216580|SUPERIORITY|||||||0.93|||||||Kruskal-Wallis|||||||0.93
73834054|NCT01692756|147216581|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
73834055|NCT01692756|147216582|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
73834056|NCT01692756|147216583|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||.003
73834057|NCT01692756|147216584|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||.007
73834058|NCT01692756|147216585|SUPERIORITY|||||||0.63|||||||Kruskal-Wallis|||||||.63
73834059|NCT01692756|147216586|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||||||0.17
73834060|NCT01692756|147216587|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||||||.62
73834061|NCT01692756|147216588|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||.02
73834062|NCT01692756|147216589|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||.20
73834063|NCT01692756|147216590|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||||||.87
73834064|NCT02969018|147216591|OTHER||Least Squares Mean Difference|-8.64|STANDARD_ERROR_OF_MEAN|2.232||0.0005|TWO_SIDED|90.0|-12.33|-4.95||Hochberg adjusted p-value|Mixed Models Analysis|||||-4.95|-12.33|0.0005
73834065|NCT02969018|147216591|OTHER||Least Squares Mean Difference|-3.34|STANDARD_ERROR_OF_MEAN|2.206||0.0963|TWO_SIDED|90.0|-6.99|0.3||Hochberg adjusted p-value|Mixed Models Analysis|||||0.30|-6.99|0.0963
73834066|NCT02969018|147216591|OTHER||Least Squares Mean Difference|-7.07|STANDARD_ERROR_OF_MEAN|2.233||0.0046|TWO_SIDED|90.0|-10.76|-3.37||Hochberg adjusted p-value|Mixed Models Analysis|||||-3.37|-10.76|0.0046
73834067|NCT02969018|147216591|OTHER||Least Squares Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.238||0.0963|TWO_SIDED|90.0|-6.63|0.77||Hochberg adjusted p-value|Mixed Models Analysis|||||0.77|-6.63|0.0963
73834068|NCT02969018|147216591|OTHER||Least Squares Mean Difference|-10.07|STANDARD_ERROR_OF_MEAN|2.152|<|0.0001|TWO_SIDED|90.0|-13.63|-6.51||Hochberg adjusted p-value|Mixed Models Analysis|||||-6.51|-13.63|<0.0001
73834069|NCT02969018|147216591|OTHER||Least Squares Mean Difference|-6.06|STANDARD_ERROR_OF_MEAN|2.255||0.0158|TWO_SIDED|90.0|-9.79|-2.33||Hochberg adjusted p-value|Mixed Models Analysis|||||-2.33|-9.79|0.0158
73834070|NCT02969018|147216591|OTHER||Least Squares Mean Difference|-4.66|STANDARD_ERROR_OF_MEAN|2.163||0.0488|TWO_SIDED|90.0|-8.24|-1.09||Hochberg adjusted p-value|Mixed Models Analysis|||||-1.09|-8.24|0.0488
73834071|NCT02969018|147216592|OTHER||Odds Ratio (OR)|10.0|||||TWO_SIDED|90.0|2.95|33.87|||||||Logistic regression|33.87|2.95|
73834072|NCT02969018|147216592|OTHER||Odds Ratio (OR)|2.12|||||TWO_SIDED|90.0|0.61|7.36|||||||Logistic regression|7.36|0.61|
73834073|NCT02969018|147216592|OTHER||Odds Ratio (OR)|9.09|||||TWO_SIDED|90.0|2.71|30.48|||||||Logistic regression|30.48|2.71|
73834074|NCT02969018|147216592|OTHER||Odds Ratio (OR)|2.11|||||TWO_SIDED|90.0|0.59|7.55|||||||Logistic regression|7.55|0.59|
73834075|NCT02969018|147216592|OTHER||Odds Ratio (OR)|41.67|||||TWO_SIDED|90.0|10.8|160.68|||||||Logistic regression|160.68|10.80|
73834076|NCT02969018|147216592|OTHER||Odds Ratio (OR)|2.11|||||TWO_SIDED|90.0|0.59|7.55|||||||Logistic regression|7.55|0.59|
73834077|NCT02969018|147216592|OTHER||Odds Ratio (OR)|3.86|||||TWO_SIDED|90.0|1.17|12.74|||||||Logistic regression|12.74|1.17|
73834078|NCT02969018|147216593|OTHER||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|90.0|-11.43|-6.57|||Mixed Models Analysis|||||-6.57|-11.43|<0.0001
73834079|NCT02969018|147216593|OTHER||Least Squares Mean Difference|-7.99|STANDARD_ERROR_OF_MEAN|1.502|<|0.0001|TWO_SIDED|90.0|-10.48|-5.51|||Mixed Models Analysis|||||-5.51|-10.48|<0.0001
73834080|NCT04018001|147216605|SUPERIORITY|||||||0.0115|||||||Chi-squared|||||||0.0115
73834081|NCT04018001|147216605|SUPERIORITY||Odds Ratio (OR)|1.410198||||0.0227|TWO_SIDED|95.0|1.0492535|1.8953079||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.8953079|1.0492535|0.0227
73834082|NCT04018001|147216606|SUPERIORITY|||||||0.3564|||||||t-test, 2 sided|||||||0.3564
73834083|NCT04018001|147216606|SUPERIORITY||Hazard Ratio (HR)|0.9022||||0.2629|TWO_SIDED|95.0|0.7534|1.0803||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox|||||1.0803|0.7534|0.2629
73834084|NCT04018001|147216607|SUPERIORITY|||||||0.0123|||||||t-test, 2 sided|||||||0.0123
73834085|NCT04018001|147216607|SUPERIORITY||Difference in Least Squares (LS) Means|0.0300853||||0.0047|TWO_SIDED|95.0|0.0092322|0.0509385||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0509385|0.0092322|0.0047
73834086|NCT04018001|147216608|SUPERIORITY|||||||0.0002|||||||Chi-squared|||||||0.0002
73834087|NCT04018001|147216608|SUPERIORITY||Odds Ratio (OR)|1.7910474||||0.0002|TWO_SIDED|95.0|1.3167136|2.4362554||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||2.4362554|1.3167136|0.0002
73834088|NCT04018001|147216609|SUPERIORITY|||||||0.4071|||||||t-test, 2 sided|||||||0.4071
73834089|NCT04018001|147216609|SUPERIORITY||Difference in LS Means|0.0104065||||0.6143|TWO_SIDED|95.0|-0.030062|0.0508746||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0508746|-0.030062|0.6143
73834090|NCT04018001|147216610|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.0010
73834091|NCT04018001|147216610|SUPERIORITY||Odds Ratio (OR)|1.5211586||||0.0025|TWO_SIDED|95.0|1.1594614|1.9956882||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.9956882|1.1594614|0.0025
73834092|NCT04018001|147216611|SUPERIORITY|||||||0.4595|||||||t-test, 2 sided|||||||0.4595
73834093|NCT04018001|147216611|SUPERIORITY||Hazard Ratio (HR)|1.1225||||0.3354|TWO_SIDED|95.0|0.8873|1.4201||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox|||||1.4201|0.8873|0.3354
73834094|NCT04018001|147216612|SUPERIORITY|||||||0.113|||||||t-test, 2 sided|||||||0.1130
73834095|NCT04018001|147216612|SUPERIORITY||Difference in LS Means|0.0151242||||0.1194|TWO_SIDED|95.0|-0.003908|0.0341568||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0341568|-0.003908|0.1194
73834096|NCT04018001|147216613|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.0200
73834097|NCT04018001|147216613|SUPERIORITY||Odds Ratio (OR)|1.4143816||||0.0364|TWO_SIDED|95.0|1.0221455|1.9571335||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.9571335|1.0221455|0.0364
73834098|NCT04018001|147216614|SUPERIORITY|||||||0.9031|||||||t-test, 2 sided|||||||0.9031
73834099|NCT04018001|147216614|SUPERIORITY||Difference in LS Means|-0.008587||||0.6376|TWO_SIDED|95.0|-0.044317|0.0271416||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0271416|-0.044317|0.6376
73834100|NCT04018001|147216615|SUPERIORITY|||||||0.3584|||||||Chi-squared|||||||0.3584
73834101|NCT04018001|147216615|SUPERIORITY||Odds Ratio (OR)|1.1077385||||0.451|TWO_SIDED|95.0|0.8489444|1.4454238||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.4454238|0.8489444|0.4510
73834102|NCT04018001|147216616|SUPERIORITY|||||||0.0624|||||||Chi-squared|||||||0.0624
73834103|NCT04018001|147216617|SUPERIORITY|||||||0.4914|||||||Chi-squared|||||||0.4914
73834104|NCT06377488|147216663|SUPERIORITY||least-square mean estimate|-0.085|STANDARD_ERROR_OF_MEAN|0.0139|||TWO_SIDED|95.0|-0.115|-0.056|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at distance was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||-0.056|-0.115|
73834105|NCT06377488|147216663|SUPERIORITY||least-square mean estimate|-0.023|STANDARD_ERROR_OF_MEAN|0.0131|||TWO_SIDED|95.0|-0.05|0.005|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at intermediate was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||0.005|-0.050|
73834106|NCT06377488|147216663|SUPERIORITY||least-square mean estimate|0.083|STANDARD_ERROR_OF_MEAN|0.0152|||TWO_SIDED|95.0|0.051|0.116|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at near was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||0.116|0.051|
73834107|NCT06377488|147216664|SUPERIORITY||Mean Population Estimate|62.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|56.7|67.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes only using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 29 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||67.5|56.7|
73834108|NCT06377488|147216664|SUPERIORITY||Mean Population Estimate|57.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|51.7|64.0|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes only using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 29 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||64.0|51.7|
73834109|NCT06377488|147216665|SUPERIORITY||Central Posterior Mean Estimate|0.943|STANDARD_DEVIATION|0.0155|||TWO_SIDED|95.0|0.908|0.968|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.902 and an intraclass correlation of 0.70, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 96% with 95% central posterior credible interval.||0.968|0.908|
73896669|NCT00955201|147326625|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks||||0.51
73896670|NCT00955201|147326625|SUPERIORITY|||||||0.94|||||||ANOVA|||Comparison across groups at 24-wks||||0.94
73834110|NCT06377488|147216666|SUPERIORITY||Central Posterior Mean Estimate|0.988|STANDARD_DEVIATION|0.0058|||TWO_SIDED|95.0|0.974|0.997|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 96% with 95% central posterior credible interval.||0.997|0.974|
73834111|NCT06377488|147216667|SUPERIORITY||Central Posterior Mean Estimate|0.006|STANDARD_DEVIATION|0.0047|||TWO_SIDED|95.0|0.0|0.017|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.017|0.000|
73834112|NCT06377488|147216668|SUPERIORITY||Central Posterior Mean Estimate|0.003|STANDARD_DEVIATION|0.0029|||TWO_SIDED|95.0|0.0|0.011|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.011|0.000|
73834113|NCT06377488|147216669|SUPERIORITY||Least-square mean estimate|57.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|51.7|64.0|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|This is the analysis for hyperopes only. Mean estimates were conducted using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 42 and 55 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||64.0|51.7|
73834114|NCT06377488|147216669|SUPERIORITY||Least-square mean estimate|62.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|56.7|67.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|This is the analysis for myopes only. Mean estimates were conducted using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 42 and 55 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||67.5|56.7|
73834115|NCT06377488|147216670|SUPERIORITY||Mean Population Estimate|64.7|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|58.6|70.8|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 46 subjects were required to test for superiority for CLUE comfort scores for hyperopes and myopes, respectively.||70.8|58.6|
73834116|NCT06377488|147216670|SUPERIORITY||Mean Population Estimate|64.2|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|95.0|59.0|69.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 46 subjects were required to test for superiority for CLUE comfort scores for hyperopes and myopes, respectively.||69.5|59.0|
73834117|NCT06377488|147216671|SUPERIORITY||Mean Population Estimate|67.9|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|62.2|73.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 15 and 26 subjects were required to test for superiority for CLUE handling scores for hyperopes and myopes, respectively.||73.5|62.2|
73834118|NCT06377488|147216671|SUPERIORITY||Mean Population Estimate|67.0|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|62.2|71.8|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 15 and 26 subjects were required to test for superiority for CLUE handling scores for hyperopes and myopes, respectively.||71.8|62.2|
73834119|NCT06377488|147216672|SUPERIORITY||Central Posterior Mean Estimate|0.966|STANDARD_DEVIATION|0.0135|||TWO_SIDED|95.0|0.933|0.988|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data.||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70 with 5000 replicating trials, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.988|0.933|
73834120|NCT01179516|147216673|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.488||0.597|TWO_SIDED|95.0|-3.71|2.14||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure for each dose was applied to compare 10 mg and 15 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||2.14|-3.71|0.597
73834121|NCT01179516|147216673|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|1.501||0.745|TWO_SIDED|95.0|-3.44|2.46||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||2.46|-3.44|0.745
73834122|NCT01179516|147216674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.232||||0.396|TWO_SIDED|95.0|0.761|1.995|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.995|0.761|0.396
73896671|NCT00955201|147326626|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
73834123|NCT01179516|147216674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.212||||0.435|TWO_SIDED|95.0|0.748|1.963|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.963|0.748|0.435
73834124|NCT01179516|147216675|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.149||0.554|TWO_SIDED|95.0|-0.38|0.21|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.21|-0.38|0.554
73834125|NCT01179516|147216675|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.151||0.739|TWO_SIDED|95.0|-0.35|0.25|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.25|-0.35|0.739
73834126|NCT01179516|147216676|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|2.261||0.67|TWO_SIDED|95.0|-5.43|3.5|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||3.50|-5.43|0.670
73834127|NCT01179516|147216676|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.295||0.451|TWO_SIDED|95.0|-2.8|6.26|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||6.26|-2.80|0.451
73834128|NCT01179516|147216677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.291||||0.352|TWO_SIDED|95.0|0.754|2.211|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.||||2.211|0.754|0.352
73834129|NCT01179516|147216677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.116||||0.694|TWO_SIDED|95.0|0.646|1.928|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.||||1.928|0.646|0.694
73834130|NCT01179516|147216678|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|1.25||0.464|TWO_SIDED|95.0|-3.38|1.55|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||1.55|-3.38|0.464
73834131|NCT01179516|147216678|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|1.322||0.6|TWO_SIDED|95.0|-1.91|3.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||3.30|-1.91|0.600
73834132|NCT02965456|147216682|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
73834133|NCT02965456|147216683|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
73834134|NCT02965456|147216684|SUPERIORITY|||||||0.007||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth's Penalized Likelihood) with factors of treatment group and analysis center.||||0.007
73834135|NCT04465955|147216690|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.4345|TWO_SIDED|95.0|-0.528|0.227|||Random coefficient model|Covariates included terms for time, treatment-by-time interaction, baseline fellow eye CNV status, baseline focality, and baseline GA lesion location||Rate of Change Difference Between NGM621 Q4W and Pooled Sham||0.227|-0.528|0.4345
73834136|NCT04465955|147216690|SUPERIORITY||Mean Difference (Final Values)|-0.155||||0.4217|TWO_SIDED|95.0|-0.536|0.225|||Random coefficient model|Covariates included terms for time, treatment-by-time interaction, baseline fellow eye CNV status, baseline focality, and baseline GA lesion location||Rate of Change Difference Between NGM621 Q8W and Pooled Sham||0.225|-0.536|0.4217
73834137|NCT00387127|147216708|SUPERIORITY_OR_OTHER||Difference in percentage of par. with CR|10.7||||0.3658|TWO_SIDED|95.0|-13.4|37.3||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by an independent radiological review.|||37.3|-13.4|0.3658
73834138|NCT00387127|147216709|SUPERIORITY_OR_OTHER||Difference in percentage of par. with CR|28.8||||0.013|TWO_SIDED|95.0|5.7|53.6||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by the investigator.|||53.6|5.7|0.0130
73834139|NCT00387127|147216718|SUPERIORITY_OR_OTHER||Difference in overall response rate|16.3||||0.1969|TWO_SIDED|95.0|-8.6|42.1||From exact test that common odds ratio equals 1|Fisher Exact||Overall response was defined as the percentage of participants achieving a PR or CR as determined by the investigator.|||42.1|-8.6|0.1969
73834140|NCT02762604|147216750|SUPERIORITY||Mean Difference (Net)|-2.12|STANDARD_ERROR_OF_MEAN|8.79|||TWO_SIDED|95.0|-19.36|15.12|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in normal pace gait speed pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||15.12|-19.36|
73834141|NCT02762604|147216750|SUPERIORITY||Mean Difference (Net)|17.19|STANDARD_ERROR_OF_MEAN|8.05|||TWO_SIDED|95.0|1.4|32.97|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in gait speed during walking while talking pre and post intervention||32.97|1.40|
73834142|NCT02762604|147216751|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|0.21|2.99|||||The estimate parameter reflects change in the number of correct letters generated pre to post intervention as a function intervention (Imagined Gait vs. Visual Imagery).|A linear mixed effects model was used to compare changes in correct letters generated pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.99|0.21|
73834143|NCT02762604|147216752|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|7.37|||TWO_SIDED|95.0|-12.04|16.85|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (Imagined Gait vs. Visual Imagery).|Linear mixed effects model were used to compare changes in the functional activation/deactivation pattern (factor score) during imagery of walking-while talking (relative to walking and talking alone) pre and post intervention - as a function of of intervention (Imagined Gait vs. Visual Imagery)||16.85|-12.04|
73896672|NCT00955201|147326626|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.97
73896673|NCT00955201|147326626|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.96
73834144|NCT02762604|147216753|SUPERIORITY||Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|6.94|||TWO_SIDED|95.0|-14.15|13.07|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails a time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||13.07|-14.15|
73834145|NCT02762604|147216754|SUPERIORITY||Mean Difference (Net)|-12.21|STANDARD_ERROR_OF_MEAN|20.26|||TWO_SIDED|95.0|-51.92|27.51|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails b time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||27.51|-51.92|
73834146|NCT02762604|147216755|SUPERIORITY||Mean Difference (Net)|-10.83|STANDARD_ERROR_OF_MEAN|19.03|||TWO_SIDED|95.0|-48.12|26.47|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails B minus A time pre and post intervention.||26.47|-48.12|
73834147|NCT02762604|147216756|SUPERIORITY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-2.65|0.79|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in correct letter number sequences pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.79|-2.65|
73834148|NCT02762604|147216757|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|12.95|||TWO_SIDED|95.0|-24.0|26.78|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in Stroop interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||26.78|-24.00|
73834149|NCT02762604|147216758|SUPERIORITY||Mean Difference (Net)|6.76|STANDARD_ERROR_OF_MEAN|79.95|||TWO_SIDED|95.0|-149.94|163.47|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in flanker interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||163.47|-149.94|
73834150|NCT02762604|147216759|SUPERIORITY||Mean Difference (Net)|15.2|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|5.99|24.41|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in stride length during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||24.41|5.99|
73834151|NCT02762604|147216760|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-3.73|-0.2|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in gait variability during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||-0.20|-3.73|
73834152|NCT02762604|147216762|SUPERIORITY||Mean Difference (Net)|2.43|STANDARD_ERROR_OF_MEAN|4.29|||TWO_SIDED|95.0|-5.98|10.84|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in total free recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||10.84|-5.98|
73834153|NCT02762604|147216763|SUPERIORITY||Mean Difference (Net)|-1.94|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-5.88|2.0|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in delayed figure copy recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.00|-5.88|
73834154|NCT02762604|147216764|SUPERIORITY||Mean Difference (Net)|-6.36|STANDARD_ERROR_OF_MEAN|6.96|||TWO_SIDED|95.0|-20.01|7.28|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in word fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||7.28|-20.01|
73834155|NCT02762604|147216765|SUPERIORITY||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|-6.51|17.97|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in semantic fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||17.97|-6.51|
73834156|NCT02762604|147216766|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|8.2|||TWO_SIDED|95.0|-16.1|16.03||||||A linear mixed effects model was used to compare changes in digit symbol substitution performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)|The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|16.03|-16.10|
73834157|NCT02762604|147216768|SUPERIORITY||Mean Difference (Net)|3.64|STANDARD_ERROR_OF_MEAN|7.54|||TWO_SIDED|95.0|-11.14|18.42|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in immediate maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||18.42|-11.14|
73834158|NCT02762604|147216769|SUPERIORITY||Mean Difference (Net)|3.26|STANDARD_ERROR_OF_MEAN|12.2|||TWO_SIDED|95.0|-20.65|27.18|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in delayed maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||27.18|-20.65|
73834159|NCT02762604|147216770|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.45|0.9|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in maze errors pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.90|-0.45|
73834160|NCT02762604|147216771|SUPERIORITY||Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-1.74|2.26|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in depressive symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.26|-1.74|
73896674|NCT00955201|147326626|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
73834161|NCT02762604|147216772|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|95.0|-3.38|1.49|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in anxiety symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||1.49|-3.38|
73834162|NCT02762604|147216773|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.04|0.12|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in cortical thickness pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.12|-0.04|
73834163|NCT00699751|147216800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||5e-05|TWO_SIDED|95.0|0.578|0.827|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of overall survival, and also for the secondary endpoints, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.827|0.578|0.00005
73834164|NCT00699751|147216801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.169|||<|1e-05|TWO_SIDED|95.0|0.131|0.22|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to total ALP progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.22|0.131|<0.00001
73834165|NCT00699751|147216802|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834166|NCT00699751|147216802|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834167|NCT00699751|147216802|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=30%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=30%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834168|NCT00699751|147216802|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834169|NCT00699751|147216803|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834170|NCT00699751|147216803|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834171|NCT00699751|147216803|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834172|NCT00699751|147216804|SUPERIORITY_OR_OTHER||||||<|0.001||||||Total ALP normalization|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Total ALP normalization, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834173|NCT00699751|147216805|SUPERIORITY_OR_OTHER||||||<|0.001||||||Percentage Change from Baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834174|NCT00699751|147216806|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage decrease from baseline to week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline to week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834175|NCT00699751|147216807|SUPERIORITY_OR_OTHER||||||<|0.001||||||Percentage change from baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73896675|NCT00955201|147326626|SUPERIORITY|||||||0.16|||||||ANOVA|||Comparison across groups at baseline.||||0.16
73896676|NCT00955201|147326626|SUPERIORITY|||||||0.37|||||||ANOVA|||Comparison across groups at 12-wks||||0.37
73896677|NCT00955201|147326626|SUPERIORITY|||||||0.75|||||||ANOVA|||Comparison across groups at 24-wks||||0.75
73834176|NCT00699751|147216808|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage decrease from baseline during the 24 week treatment|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline during the 24 week treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834177|NCT00699751|147216809|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.643|||<|1e-05|TWO_SIDED|95.0|0.539|0.768||Time to Prostate Specific Antigen (PSA) progression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to PSA progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.768|0.539|<0.00001
73834178|NCT00699751|147216810|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834179|NCT00699751|147216810|SUPERIORITY_OR_OTHER|||||||0.106||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.106
73834180|NCT00699751|147216810|SUPERIORITY_OR_OTHER|||||||0.032||||||Confirmed PSA Response(\>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.032
73834181|NCT00699751|147216811|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834182|NCT00699751|147216811|SUPERIORITY_OR_OTHER|||||||0.002||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.002
73834183|NCT00699751|147216811|SUPERIORITY_OR_OTHER|||||||0.005||||||Confirmed PSA Response(\>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.005
73834184|NCT00699751|147216812|SUPERIORITY_OR_OTHER|||||||0.16||||||Percentage change from baseline in PSA at Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.160
73834185|NCT00699751|147216813|SUPERIORITY_OR_OTHER|||||||0.004||||||Maximum Percentage Decrease from Baseline up to Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline up to Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.004
73834186|NCT00699751|147216814|SUPERIORITY_OR_OTHER|||||||0.009||||||Percentage change from baseline in PSA at EOT|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at EOT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.009
73834187|NCT00699751|147216815|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
73834188|NCT00699751|147216816|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.657||||0.00012|TWO_SIDED|95.0|0.529|0.814||Time to first Skeletal Related Event (SRE)|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to first SRE, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.814|0.529|0.00012
73834189|NCT00699751|147216817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.639||||8e-05|TWO_SIDED|95.0|0.511|0.8||Time to External Beam Radiotherapy|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to EBRT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.8|0.511|0.00008
73896678|NCT00955201|147326627|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
73896679|NCT00955201|147326627|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
73896680|NCT00955201|147326627|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
73834190|NCT00699751|147216818|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.344||||0.00191|TWO_SIDED|95.0|0.17|0.695||stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Receiving Radio-isotope, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.695|0.17|0.00191
73834191|NCT00699751|147216819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.847||||0.53277|TWO_SIDED|95.0|0.504|1.426||Time to Pathological Bone Fracture|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Pathological Bone Fracture, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||1.426|0.504|0.53277
73834192|NCT00699751|147216820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949||||0.89567|TWO_SIDED|95.0|0.435|2.07||Time to Surgical Intervention|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Surgical Intervention, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||2.07|0.435|0.89567
73834193|NCT00699751|147216821|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.14486|TWO_SIDED|95.0|0.404|1.145||Time to Spinal Cord Compression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Spinal Cord Compression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||1.145|0.404|0.14486
73834194|NCT00699751|147216822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.727||||0.00932|TWO_SIDED|95.0|0.571|0.925||Time to Other Cancer Treatment|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Other Cancer Treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.925|0.571|0.00932
73834195|NCT00699751|147216823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.00187|TWO_SIDED|95.0|0.546|0.873||Time to Marked Deterioration of ECOG PS|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Marked Deterioration of ECOG PS, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.873|0.546|0.00187
73834196|NCT01257438|147216840|SUPERIORITY_OR_OTHER||Greenwood's estimate of variance|0.59|||<|0.001|TWO_SIDED|95.0|0.44|0.79|||Log Rank|||Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).||0.79|0.44|<0.001
73834197|NCT01257438|147216841|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is based on a non-inferiority Farrington and Manning Exact Test. The non-inferiority margin is 0.075 (or 7.5%).||||||0.007|TWO_SIDED||||||Farrington and Manning Exact Test|The non-inferiority margin is 0.075 (or 7.5%)||||||0.007
73834198|NCT00762177|147216882|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834199|NCT00762177|147216883|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834200|NCT00762177|147216884|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834201|NCT00762177|147216885|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834202|NCT00762177|147216886|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834203|NCT00762177|147216887|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834204|NCT00762177|147216888|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834205|NCT00762177|147216889|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||the tongue will be scrapped 5 times with the edge of a tongue depressor. The depressor is vortex in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar||||0.05
73834206|NCT00762177|147216890|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834207|NCT00762177|147216891|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834208|NCT00762177|147216892|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834209|NCT00762177|147216893|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834210|NCT00762177|147216894|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834211|NCT00762177|147216895|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834212|NCT00762177|147216896|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834213|NCT00762177|147216897|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834214|NCT00762177|147216898|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834215|NCT00762177|147216899|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834216|NCT00762177|147216900|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834217|NCT00762177|147216901|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834218|NCT00762177|147216902|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834219|NCT00762177|147216903|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834220|NCT00762177|147216904|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834221|NCT00762177|147216905|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
73834222|NCT02184156|147216913|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
73834223|NCT02184156|147216914|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
73834224|NCT00002874|147216915|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.02|TWO_SIDED|95.0|0.59|0.98||One-sided significance level = 0.046 to preserve overall significance level of 0.05 for the study.|Log Rank||Stratifying variables were fixed covariates: prior hormone therapy (yes/no), entry prostate-specific antigen (PSA) (1.6-4.0 vs. 0.2-1.5), PSA nadir after surgery (\< 0.5 vs. \>= 0.5), positive surgical margins (yes/no). Reference level = placebo arm.|||0.98|0.59|0.020
73834225|NCT00002874|147216916|SUPERIORITY||Cox Proportional Hazard|1.1||||0.289|TWO_SIDED|95.0|0.79|1.53|||Gray's test|One-sided test|||Reference level = placebo arm|1.53|0.79|0.289
73834226|NCT00002874|147216917|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.4|0.58|||Gray's test|One-sided test|Reference level = placebo arm|||0.58|0.40|<0.001
73834227|NCT00002874|147216918|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.213|TWO_SIDED|95.0|0.85|1.46|||Gray's test|One-sided test|Reference level = placebo arm|||1.46|0.85|0.213
73834228|NCT00002874|147216919|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834229|NCT00002874|147216920|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.002|TWO_SIDED|95.0|0.46|0.87|||Gray's test|One-sided test|Reference level = placebo arm|||0.87|0.46|0.002
73834230|NCT00002874|147216921|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.32|0.74|||Gray's test|One-sided test|Reference level = placebo arm|||0.74|0.32|<0.001
73834231|NCT00002874|147216922|SUPERIORITY||Cox Proportional Hazard|0.6|||<|0.001|TWO_SIDED|95.0|0.5|0.71|||Log Rank|One-side test|||Reference level = placebo arm|0.71|0.50|< 0.001
73834232|NCT00002874|147216923|SUPERIORITY|||||||0.06|||||||Chi-squared|||Acute radiotherapy toxicity||||0.060
73834233|NCT00002874|147216923|SUPERIORITY|||||||0.029|||||||Chi-squared|||Hormone therapy and late radiotherapy toxicity||||0.029
73834234|NCT00308685|147216945|OTHER||Difference in adjusted means|5.163||||0.0002|TWO_SIDED|95.0|2.478|7.847||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) with baseline FEV1 as covariate and fixed effects of pooled center and treatment group.||7.847|2.478|0.0002
73834235|NCT03158311|147216952|NON_INFERIORITY|Non-inferiority margin: 0.25 points|Least Square mean (LS Mean)|-0.038|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|ONE_SIDED|97.5|-0.139|||P-Value is one-sided|Mixed Model for Repeated Measures (MMRM)||||||-0.139|<0.001
73834236|NCT03158311|147216952|NON_INFERIORITY|Non-inferiority margin: 0.25 points|LS Mean|0.073|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|ONE_SIDED|97.5|-0.027|||P-Value is one-sided|MMRM||||||-0.027|<0.001
73834237|NCT03158311|147216953|SUPERIORITY||LS Mean|0.003|STANDARD_ERROR_OF_MEAN|0.025||0.892|TWO_SIDED|95.0|-0.046|0.052||P-value is two-sided|MMRM|||Week 8||0.052|-0.046|0.892
73834238|NCT03158311|147216953|SUPERIORITY||LS Mean|0.067|STANDARD_ERROR_OF_MEAN|0.025||0.007|TWO_SIDED|95.0|0.018|0.115||P-value is two-sided|MMRM|||Week 8||0.115|0.018|0.007
73834239|NCT03158311|147216953|SUPERIORITY||LS Mean|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.945|TWO_SIDED|95.0|-0.05|0.047||P-value is two-sided|MMRM|||Week 16||0.047|-0.050|0.945
73834240|NCT03158311|147216953|SUPERIORITY||LS Mean|0.066|STANDARD_ERROR_OF_MEAN|0.025||0.007|TWO_SIDED|95.0|0.018|0.114||P-value is two-sided|MMRM|||Week 16||0.114|0.018|0.007
73834241|NCT03158311|147216953|SUPERIORITY||LS Mean|0.009|STANDARD_ERROR_OF_MEAN|0.026||0.713|TWO_SIDED|95.0|-0.041|0.06||P-value is two-sided|MMRM|||Week 24||0.060|-0.041|0.713
73834242|NCT03158311|147216953|SUPERIORITY||LS Mean|0.096|STANDARD_ERROR_OF_MEAN|0.026|<|0.001|TWO_SIDED|95.0|0.046|0.146||P-value is two-sided|MMRM|||Week 24||0.146|0.046|<0.001
73834243|NCT03158311|147216954|SUPERIORITY||LS Mean|-0.023|STANDARD_ERROR_OF_MEAN|0.046||0.308|TWO_SIDED|95.0|-0.113|0.067||P-value is one-sided|MMRM|||Week 16||0.067|-0.113|0.308
73834244|NCT03158311|147216954|SUPERIORITY||LS Mean|-0.079|STANDARD_ERROR_OF_MEAN|0.046||0.044|TWO_SIDED|95.0|-0.169|0.012||P-value is one-sided|MMRM|||Week 16||0.012|-0.169|0.044
73834245|NCT03158311|147216954|SUPERIORITY||LS Mean|-0.032|STANDARD_ERROR_OF_MEAN|0.047||0.245|TWO_SIDED|95.0|-0.125|0.06||P-value is one sided|MMRM|||Week 24||0.060|-0.125|0.245
73834246|NCT03158311|147216954|SUPERIORITY||LS Mean|-0.124|STANDARD_ERROR_OF_MEAN|0.047||0.004|TWO_SIDED|95.0|-0.216|-0.032||P-value is one sided|MMRM|||Week 24||-0.032|-0.216|0.004
73834247|NCT03158311|147216955|SUPERIORITY||LS Mean|0.018|STANDARD_ERROR_OF_MEAN|0.049||0.719|TWO_SIDED|95.0|-0.079|0.115||P-value is two-sided|MMRM|||||0.115|-0.079|0.719
73834248|NCT03158311|147216955|SUPERIORITY||LS Mean|0.082|STANDARD_ERROR_OF_MEAN|0.049||0.097|TWO_SIDED|95.0|-0.015|0.179||P-value is two-sided|MMRM|||||0.179|-0.015|0.097
73834249|NCT03158311|147216956|SUPERIORITY||Odds Ratio (OR)|1.23||||0.061|TWO_SIDED|95.0|0.94|1.61||P-value is one sided|Regression, Logistic|Logistic Regression Model via Generalized estimating equations (GEE)||||1.61|0.94|0.061
73834250|NCT03158311|147216956|SUPERIORITY||Odds Ratio (OR)|1.11||||0.227|TWO_SIDED|95.0|0.85|1.46||P-value is one-sided|Regression, Logistic|Logistic Regression Model via GEE||||1.46|0.85|0.227
73834251|NCT03158311|147216957|SUPERIORITY||Odds Ratio (OR)|1.17||||0.108|TWO_SIDED|95.0|0.91|1.49||P-value is one sided|Regression, Logistic|Logistic regression model via the GEE||||1.49|0.91|0.108
73834252|NCT03158311|147216957|SUPERIORITY||Odds Ratio (OR)|1.33||||0.013|TWO_SIDED|95.0|1.03|1.7||P-Value is one sided|Regression, Logistic|Logistic regression model via the GEE||||1.70|1.03|0.013
73834253|NCT03158311|147216958|SUPERIORITY||LS Mean|-0.003|STANDARD_ERROR_OF_MEAN|0.027||0.908|TWO_SIDED|95.0|-0.055|0.049||P-Value is two-sided|MMRM|||Week 8||0.049|-0.055|0.908
73834254|NCT03158311|147216958|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.026||0.046|TWO_SIDED|95.0|0.001|0.104||P-Value is two-sided|MMRM|||Week 8||0.104|0.001|0.046
73834255|NCT03158311|147216958|SUPERIORITY||LS Mean|0.004|STANDARD_ERROR_OF_MEAN|0.026||0.87|TWO_SIDED|95.0|-0.047|0.056||P-Value is two-sided|MMRM|||Week 16||0.056|-0.047|0.870
73834256|NCT03158311|147216958|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.026||0.028|TWO_SIDED|95.0|0.006|0.109||P-Value is two-sided|MMRM|||Week 16||0.109|0.006|0.028
73834257|NCT03158311|147216958|SUPERIORITY||LS Mean|0.028|STANDARD_ERROR_OF_MEAN|0.028||0.303|TWO_SIDED|95.0|-0.026|0.083||P-Value is two-sided|MMRM|||Week 24||0.083|-0.026|0.303
73834258|NCT03158311|147216958|SUPERIORITY||LS Mean|0.095|STANDARD_ERROR_OF_MEAN|0.027|<|0.001|TWO_SIDED|95.0|0.041|0.148||P-Value is two-sided|MMRM|||Week 24||0.148|0.041|<0.001
73834259|NCT03158311|147216959|SUPERIORITY||LS Mean|0.02|STANDARD_ERROR_OF_MEAN|0.034||0.563|TWO_SIDED|95.0|-0.048|0.087||P-value is two-sided|MMRM|||Week 8||0.087|-0.048|0.563
73834260|NCT03158311|147216959|SUPERIORITY||LS Mean|0.062|STANDARD_ERROR_OF_MEAN|0.034||0.068|TWO_SIDED|95.0|-0.005|0.129||P-Value is two-sided|MMRM|||Week 8||0.129|-0.005|0.068
73834261|NCT03158311|147216959|SUPERIORITY||LS Mean|-0.007|STANDARD_ERROR_OF_MEAN|0.035||0.844|TWO_SIDED|95.0|-0.076|0.062||P-Value is two-sided|MMRM|||Week 16||0.062|-0.076|0.844
73834262|NCT03158311|147216959|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.035||0.097|TWO_SIDED|95.0|-0.01|0.125||P-Value is two-sided|MMRM|||Week 16||0.125|-0.010|0.097
73834263|NCT03158311|147216959|SUPERIORITY||LS Mean|0.003|STANDARD_ERROR_OF_MEAN|0.036||0.927|TWO_SIDED|95.0|-0.067|0.074||P-Value is two-sided|MMRM|||Week 24||0.074|-0.067|0.927
73834264|NCT03158311|147216959|SUPERIORITY||LS Mean|0.089|STANDARD_ERROR_OF_MEAN|0.036||0.013|TWO_SIDED|95.0|0.019|0.159||P-Value is two-sided|MMRM|||Week 24||0.159|0.019|0.013
73834265|NCT01928771|147216975|SUPERIORITY_OR_OTHER||Rate ratio|0.55|||<|0.001|TWO_SIDED|95.0|0.42|0.71|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.71|0.42|<0.001
73834266|NCT01928771|147216975|SUPERIORITY_OR_OTHER||Rate ratio|0.49|||<|0.001|TWO_SIDED|95.0|0.37|0.64|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.64|0.37|<0.001
73834267|NCT01928771|147216976|SUPERIORITY_OR_OTHER||Rate ratio|0.7||||0.047|TWO_SIDED|95.0|0.5|1.0|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||1.0|0.5|0.047
73834268|NCT01928771|147216976|SUPERIORITY_OR_OTHER||Rate ratio|0.83||||0.268|TWO_SIDED|95.0|0.59|1.16|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||1.16|0.59|0.268
73834269|NCT01928771|147216977|SUPERIORITY_OR_OTHER||Rate ratio|0.61||||0.053|TWO_SIDED|95.0|0.37|1.01|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS||||1.01|0.37|0.053
73834270|NCT01928771|147216977|SUPERIORITY_OR_OTHER||Rate ratio|0.37|||<|0.001|TWO_SIDED|95.0|0.2|0.67|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS||||0.67|0.2|<0.001
73834271|NCT01928771|147216978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54|||<|0.001|TWO_SIDED|95.0|0.37|0.78|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.78|0.37|<0.001
73834272|NCT01928771|147216978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.01|TWO_SIDED|95.0|0.43|0.9|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations from the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.90|0.43|0.01
73834273|NCT01928771|147216979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.49|0.82|||Regression, Cox|Model includes treatment, number of exacerbations in the previous year, region, use of OCS||Time to first exacerbation||0.82|0.49|<0.001
73834274|NCT01928771|147216979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.46|0.78|||Regression, Cox|Model includes treatment, number of exacerbations from the previous year, region, use of OCS||Time to first exacerbation||0.78|0.46|<0.001
73834275|NCT01928771|147216980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106||||0.022|TWO_SIDED|95.0|0.016|0.196|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.196|0.016|0.022
73834276|NCT01928771|147216980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.001|TWO_SIDED|95.0|0.068|0.249|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.249|0.068|0.001
73834277|NCT01928771|147216981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.644|TWO_SIDED|95.0|-0.134|0.083|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.083|-0.134|0.644
73834278|NCT01928771|147216981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102||||0.057|TWO_SIDED|95.0|-0.003|0.208|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.208|-0.003|0.057
73834279|NCT01928771|147216982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.442|TWO_SIDED|95.0|-0.27|0.12|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||0.12|-0.27|0.442
73834280|NCT01928771|147216982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.012|TWO_SIDED|95.0|-0.45|-0.06|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||-0.06|-0.45|0.012
73834281|NCT01928771|147216983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.169|TWO_SIDED|95.0|-0.48|0.08|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||0.08|-0.48|0.169
73834282|NCT01928771|147216983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.043|TWO_SIDED|95.0|-0.57|-0.01|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||-0.01|-0.57|0.043
73896681|NCT00955201|147326627|SUPERIORITY|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.81
73834283|NCT01928771|147216984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.1|TWO_SIDED|95.0|-1.16|0.1|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment||||0.10|-1.16|0.1
73834284|NCT01928771|147216984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.081|TWO_SIDED|95.0|-1.21|0.07|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment||||0.07|-1.21|0.081
73834285|NCT01928771|147216985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.32||||0.001|TWO_SIDED|95.0|9.2|37.43|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48||37.43|9.20|0.001
73834286|NCT01928771|147216985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.46||||0.025|TWO_SIDED|95.0|2.08|30.83|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48||30.83|2.08|0.025
73834287|NCT01928771|147216986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.75||||0.002|TWO_SIDED|95.0|7.86|35.65|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48||35.65|7.86|0.002
73834288|NCT01928771|147216986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.18||||0.008|TWO_SIDED|95.0|5.09|33.28|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48||33.28|5.09|0.008
73834289|NCT01928771|147216987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.964|TWO_SIDED|95.0|-0.05|0.04|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment||||0.04|-0.05|0.964
73834290|NCT01928771|147216987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.012|TWO_SIDED|95.0|-0.11|-0.01|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment||||-0.01|-0.11|0.012
73834291|NCT01928771|147216988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.111|TWO_SIDED|95.0|-0.34|0.04|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.04|-0.34|0.111
73834292|NCT01928771|147216988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.003|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||-0.10|-0.48|0.003
73834293|NCT01928771|147216989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.27|0.27|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.27|-0.27|0.99
73834294|NCT01928771|147216989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.107|TWO_SIDED|95.0|-0.48|0.05|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.05|-0.48|0.107
73834295|NCT01928771|147216993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.081|TWO_SIDED|95.0|-0.02|0.37|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment||||0.37|-0.02|0.081
73834296|NCT01928771|147216993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment||||0.5|0.1|0.004
73834297|NCT03921541|147216999|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73834298|NCT03921541|147217000|SUPERIORITY|||||||0.5961|||||||Mixed Models Analysis|||||||0.5961
73834299|NCT03921541|147217001|SUPERIORITY|||||||0.1087|||||||Mixed Models Analysis|||||||0.1087
73834300|NCT03921541|147217002|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73834301|NCT03921541|147217003|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
73834302|NCT03921541|147217004|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73834303|NCT03921541|147217006|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
73834304|NCT03921541|147217007|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73834305|NCT03921541|147217008|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73834306|NCT03921541|147217009|SUPERIORITY|||||||0.0208|||||||Mixed Models Analysis|||||||0.0208
73834307|NCT03921541|147217010|SUPERIORITY|||||||0.4434|||||||Mixed Models Analysis|||||||0.4434
73834308|NCT03921541|147217011|SUPERIORITY|||||||0.5301|||||||Mixed Models Analysis|||||||0.5301
73834309|NCT03921541|147217012|SUPERIORITY|||||||0.2515|||||||Mixed Models Analysis|||||||0.2515
73834310|NCT02642679|147217017|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we had 95% power to detect an improvement of 2 points in VAS score assuming a common standard deviation of 1 point with a two sided two sample t-test each at alpha=0.17 level.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in pain. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
73834311|NCT02642679|147217018|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 80% power to detect an improvement in re-epithelialization from 14.6 days to 10 days assuming a common standard deviation of 2.9 days.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing rate. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
73834312|NCT02642679|147217019|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 95% power to detect an improvement of 2 points in VSS score assuming a common standard deviation of 1 point.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing quality. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
73896682|NCT00955201|147326627|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at baseline||||0.28
73834313|NCT01112267|147217032|SUPERIORITY_OR_OTHER|||||||0.0367|||||||Cochran-Mantel-Haenszel|p-value for percentage of participants with reduction in pain intensity was calculated for tramadol HCl/acetaminophen and placebo groups||||||0.0367
73834314|NCT01112267|147217033|SUPERIORITY_OR_OTHER|||||||0.0095||||||p-value for change in reduction in pain intensity at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Mann-Whitney U test|||||||0.0095
73834315|NCT01112267|147217034|SUPERIORITY_OR_OTHER|||||||0.0202||||||p-value for percentage of participants with pain relief at Day 8 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.0202
73834316|NCT01112267|147217034|SUPERIORITY_OR_OTHER|||||||0.0102||||||p-value for percentage of participants with pain relief at Day 15 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.0102
73834317|NCT01112267|147217034|SUPERIORITY_OR_OTHER|||||||0.4652||||||p-value for percentage of participants with pain relief at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.4652
73834318|NCT01112267|147217035|SUPERIORITY_OR_OTHER|||||||0.3524||||||p-value for change from Baseline in physical conditioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups|Wilcoxon (Mann-Whitney)|||||||0.3524
73834319|NCT01112267|147217035|SUPERIORITY_OR_OTHER|||||||0.0224||||||p-value for change from Baseline in role physical at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0224
73834320|NCT01112267|147217035|SUPERIORITY_OR_OTHER|||||||0.5712||||||p-value for change from Baseline in bodily pain at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.5712
73834321|NCT01112267|147217035|SUPERIORITY_OR_OTHER|||||||0.0395||||||p-value for change from Baseline in general health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0395
73834322|NCT01112267|147217035|SUPERIORITY_OR_OTHER|||||||0.0524||||||p-value for change from Baseline in vitality at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0524
73834323|NCT01112267|147217035|SUPERIORITY_OR_OTHER|||||||0.115||||||p-value for change from Baseline in social functioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.115
73834324|NCT01112267|147217035|SUPERIORITY_OR_OTHER|||||||0.7788||||||p-value for change from Baseline in role emotional at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.7788
73834325|NCT01112267|147217035|SUPERIORITY_OR_OTHER|||||||0.7776||||||p-value for change from Baseline in mental health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.7776
73834326|NCT01112267|147217035|SUPERIORITY_OR_OTHER|||||||0.0047||||||p-value for change from Baseline in Reptd. health transition at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0047
73834327|NCT01112267|147217036|SUPERIORITY_OR_OTHER|||||||0.0527||||||p-value for change from Baseline in ODI- Korean version at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0527
73834328|NCT01112267|147217037|SUPERIORITY_OR_OTHER|||||||0.0917||||||p-value for investigator's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared|||||||0.0917
73834329|NCT01112267|147217038|SUPERIORITY_OR_OTHER|||||||0.5632||||||p-value for participant's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared|||||||0.5632
73834330|NCT05638737|147217062|SUPERIORITY|One-sided test where a negative change in relative to baseline is favourable|%-change in relative to base vs placebo|7.5||||0.893|TWO_SIDED|95.0|-4.1|20.5|||Mixed Models Analysis|Participant as random effect; treatment, visit and trt:vis interaction as fixed effects; baseline ALT as covariate. Model uses log-scaled variables.||||20.5|-4.1|0.893
73834331|NCT05638737|147217063|SUPERIORITY|One-sided test where a negative change in relative to baseline is favourable|%-change in relative to base vs placebo|-0.9||||0.396|TWO_SIDED|95.0|-7.5|6.1|||Mixed Models Analysis|Participant as random effect; treatment, visit and trt:vis interaction as fixed effects; baseline Pro-C3 as covariate. Model uses log-scaled variables||||6.1|-7.5|0.396
73834332|NCT04633447|147217065|SUPERIORITY||Difference in Percentage|6.6|||=|0.638|TWO_SIDED|90.0|-14.7|27.9|||Cochran-Mantel-Haenszel|||||27.9|-14.7|=0.638
73834333|NCT04333498|147217083|OTHER||Mean Difference (Net)|-221.03||||0.014|TWO_SIDED|95.0|-396.33|-45.73|||t-test, 2 sided|||||-45.73|-396.33|.014
73834334|NCT04333498|147217084|OTHER||Mean Difference (Net)|1103.96||||0.122|TWO_SIDED|95.0|-296.532|2502.722|||t-test, 2 sided|||||2502.722|-296.532|0.122
73834335|NCT04333498|147217085|OTHER||Mean Difference (Net)|-2.61||||0.218|TWO_SIDED|95.0|-8.614|3.391|||t-test, 2 sided|||Adherence percentage||3.391|-8.614|.218
73834336|NCT04333498|147217085|OTHER|Linear regression with generalized estimating equations (GEE)|Slope|0.046||||0.272|TWO_SIDED|95.0|-0.036|0.128|||Regression, Linear|||||0.128|-0.036|0.272
73834337|NCT01565694|147217086|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
73834338|NCT01565694|147217086|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
73834339|NCT01565694|147217087|OTHER|P-Value was obtained from a 2-sided one sample t-test, testing the null hypothesis that Change from Baseline=0.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
73834340|NCT01565694|147217088|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.029|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.029
73834341|NCT01565694|147217088|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.026|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.026
73834342|NCT01565694|147217089|OTHER|From a Wilcoxon Signed Rank testing the null hypothesis is that the Median at Week 24 is equal to Baseline Median.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Analysis of change from baseline to Week 24.||||<0.001
73834343|NCT01565694|147217090|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.006|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 in bladder volume at 30 cmH20.||||0.006
73896683|NCT00955201|147326627|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at 12-wks||||0.28
73834344|NCT01565694|147217090|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF in bladder volume at 30 cmH20.||||0.001
73834345|NCT01565694|147217091|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 in bladder volume at 40 cmH20.||||0.001
73834346|NCT01565694|147217091|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 LOCF in bladder volume at 40 cmH20.||||0.004
73834347|NCT01565694|147217092|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.003|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.003
73834348|NCT01565694|147217092|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.028|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.028
73834349|NCT01565694|147217093|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.068|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.068
73834350|NCT01565694|147217093|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.075|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.075
73834351|NCT01565694|147217094|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
73834352|NCT01565694|147217094|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
73834353|NCT01565694|147217095|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
73834354|NCT01565694|147217095|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
73834355|NCT01565694|147217096|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
73834356|NCT01565694|147217096|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
73834357|NCT01565694|147217097|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
73834358|NCT01565694|147217097|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
73834359|NCT01565694|147217098|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.01|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.010
73834360|NCT01565694|147217098|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.004
73834361|NCT01565694|147217099|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
73834362|NCT01565694|147217099|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
73834363|NCT01565694|147217100|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.568|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.568
73834364|NCT01565694|147217100|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.573|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.573
73834365|NCT06059066|147217116|OTHER|||||||0.57||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Willingness to repeat procedure immediately after received intradetrusor BTX-A injections||||0.57
73834366|NCT06059066|147217116|OTHER|||||||0.83||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Willingness to repeat procedure asses 6-weeks after intradetrusor BTX-A injections||||0.83
73834367|NCT06059066|147217117|OTHER|||||||0.59||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in total ICIQ-SF score assessed before and 6-weeks after treatment||||0.59
73834368|NCT06059066|147217117|OTHER|||||||0.29||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in ICIQ QoL score assessed before and 6-weeks after treatment||||0.29
73834369|NCT06059066|147217118|OTHER|||||||0.57||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in total NBSS-SF score assessed before and 6-weeks after treatment||||0.57
73834370|NCT06059066|147217118|OTHER|||||||0.42||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF QoL score assessed before and 6-weeks after treatment||||0.42
73834371|NCT06059066|147217118|OTHER|||||||0.24||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF incontinence domain score assessed before and 6-weeks after treatment||||0.24
73834372|NCT06059066|147217118|OTHER|||||||0.93||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF storage and voiding domain score assessed before and 6-weeks after treatment||||0.93
73834373|NCT06059066|147217118|OTHER|||||||0.64||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF consequences domain score assessed before and 6-weeks after treatment||||0.64
73834374|NCT06059066|147217119|OTHER|||||||0.21||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||||||0.21
73896684|NCT00955201|147326627|SUPERIORITY|||||||0.83|||||||ANOVA|||Comparison across groups at 24-wks||||0.83
73834375|NCT06059066|147217120|OTHER||||||<|2e-05||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Change in post-procedural pain as compared to baseline||||<0.00002
73834376|NCT00541229|147217129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.8||||0.004||95.0|-53.1|-10.5|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 200 mg group.||-10.5|-53.1|0.004
73834377|NCT00541229|147217129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.9|||<|0.001||95.0|-63.6|-20.2|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 100 mg group.||-20.2|-63.6|<0.001
73834378|NCT00541229|147217129|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis stated that the lower bound of 80% one-sided confidence interval for the comparison in 24-hour WMG reduction between sitagliptin 200 mg and sitagliptin 100 mg is above -5 mg/dL.|Mean Difference (Final Values)|10.1||||||80.0|0.61|9999999.0|||||This is a 1-sided 80% confidence interval and the upper bound 9999999 was used here to indicate positive infinity.|This was pre-defined as a non-superiority test, i.e., to show that sitagliptin 200 mg is not superior to sitagliptin 100 mg. For this comparison, the mean in the sitagliptin 100 mg group was subtracted from the mean in the sitagliptin 200 mg group.||9999999|0.61|
73834379|NCT01807520|147217185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.7|STANDARD_ERROR_OF_MEAN|6.26|<|0.0001|TWO_SIDED|95.0|-39.1|-14.3|||Mixed model reapeated measures|||||-14.3|-39.1|<0.0001
73834380|NCT01807520|147217185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.4|STANDARD_ERROR_OF_MEAN|5.47|<|0.0001|TWO_SIDED|95.0|-45.2|-23.5|||Mixed model repeated measures|||||-23.5|-45.2|<0.0001
73834381|NCT05177094|147217218|SUPERIORITY||Posterior Mean Difference|-0.15|||||TWO_SIDED|95.0|-0.7|0.4|||||Posterior mean difference with 95% credible interval is reported.|||0.40|-0.70|
73834382|NCT05177094|147217219|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.66|0.64|||||Posterior mean difference with 95% credible interval is reported.|||0.64|-0.66|
73834383|NCT05177094|147217220|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.72|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.72|
73834384|NCT05177094|147217221|SUPERIORITY||Posterior Mean Difference|-0.26|||||TWO_SIDED|95.0|-0.98|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.98|
73834385|NCT05177094|147217222|SUPERIORITY||Posterior Mean Difference|-0.22|||||TWO_SIDED|95.0|-0.61|0.18|||||Posterior mean difference with 95% credible interval is reported.|||0.18|-0.61|
73834386|NCT05177094|147217223|SUPERIORITY||Posterior Mean Difference|-0.17|||||TWO_SIDED|95.0|-0.58|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.58|
73834387|NCT05177094|147217224|SUPERIORITY||Posterior Mean Difference|-0.12|||||TWO_SIDED|95.0|-0.68|0.45|||||Posterior mean difference with 95% credible interval is reported.|||0.45|-0.68|
73834388|NCT05177094|147217225|SUPERIORITY||Posterior Mean Difference|0.06|||||TWO_SIDED|95.0|-0.65|0.77|||||Posterior mean difference with 95% credible interval is reported.|||0.77|-0.65|
73834389|NCT05177094|147217226|SUPERIORITY||Posterior Mean Difference|-3.09|||||TWO_SIDED|95.0|-10.43|4.28|||||Posterior mean difference with 95% credible interval is reported.|||4.28|-10.43|
73834390|NCT05177094|147217227|SUPERIORITY||Posterior Mean Difference|-1.5|||||TWO_SIDED|95.0|-10.04|7.0|||||Posterior mean difference with 95% credible interval is reported.|||7.00|-10.04|
73834391|NCT05177094|147217228|SUPERIORITY||Posterior Mean Difference|0.12|||||TWO_SIDED|95.0|-0.32|0.54|||||Posterior mean difference with 95% credible interval is reported.|||0.54|-0.32|
73834392|NCT05177094|147217229|SUPERIORITY||Posterior Mean Difference|0.2|||||TWO_SIDED|95.0|-0.24|0.65|||||Posterior mean difference with 95% credible interval is reported.|||0.65|-0.24|
73834393|NCT05177094|147217230|SUPERIORITY||Posterior Mean Difference|44.36|||||TWO_SIDED|95.0|-114.73|204.0|||||Posterior mean difference with 95% credible interval is reported.|||204.00|-114.73|
73834394|NCT05177094|147217231|SUPERIORITY||Posterior Mean Difference|-98.76|||||TWO_SIDED|95.0|-231.86|34.49|||||Posterior mean difference with 95% credible interval is reported.|||34.49|-231.86|
73834395|NCT05177094|147217232|SUPERIORITY||Posterior Mean Difference|0.01|||||TWO_SIDED|95.0|-0.05|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.05|
73834396|NCT05177094|147217233|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.09|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.09|
73834397|NCT02400736|147217234|SUPERIORITY|"Proportion of steady workers in each group was analyzed using a logistic regression model to calculate an odds ratio and 95% Confidence Interval. Adhering to the principle of intent-to-treat, participants were retained in the arm to which they were randomized for the 12-month follow-up period despite discontinuing the treatment intervention or exiting the study early. Missing data was counted as not worked."|Odds Ratio (OR)|2.49||||0.02|TWO_SIDED|95.0|1.14|5.43||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Chi-squared|||Using SamplePower 3.0 to estimate the statistical power, the target sample size of 120 (60 per group) provided 84% power to detect a 25% or greater absolute difference between groups in the percent of participants achieving 'steady worker' status (e.g., 40% in IPS vs. 15% in control arm), at the .05 level of significance, assuming a 10% attrition.||5.43|1.14|0.02
73834398|NCT02400736|147217235|SUPERIORITY|Intent to treat analysis.||||||0.003||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||Total mean time worked was compared using an analysis of variance (ANOVA).||||0.003
73834399|NCT02400736|147217236|SUPERIORITY|||||||0.005||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|||intent to treat analysis||||0.005
73834400|NCT02400736|147217237|SUPERIORITY|a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.||||||0.033|||||||t-test, 2 sided|||||||0.033
73834401|NCT02400736|147217238|SUPERIORITY|||||||0.853||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|Effect of treatment on outcome was analyzed using longitudinal mixed-effects regression model.Group by time interaction tested for treatment effect.||||||0.853
73834402|NCT02400736|147217239|SUPERIORITY|a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.||||||0.004|||||||t-test, 2 sided|||||||0.004
73896685|NCT00955201|147326628|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
73896686|NCT00955201|147326628|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
73834403|NCT02400736|147217240|SUPERIORITY|||||||0.47||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|Effect of treatment on outcome was analyzed using longitudinal mixed-effects regression model.Group by time interaction tested for treatment effect.||The effect of treatment on each of secondary outcome measures were analyzed using a longitudinal mixed-effects regression model. The group by time interaction tested for the treatment effect.||||0.47
73834404|NCT02400736|147217241|SUPERIORITY|||||||0.062||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.062
73834405|NCT02400736|147217242|SUPERIORITY||||||>|0.3||||||a priori threshold for statistical significance p \</= 0.05 or lower. No adjustments were made for multiple comparisons.|ANOVA|||||||>0.3
73834406|NCT02400736|147217243|SUPERIORITY|||||||0.001||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.001
73834407|NCT02400736|147217244|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Chi-squared|||||||0.006
73834408|NCT00421733|147217284|SUPERIORITY_OR_OTHER|||||||0.071||||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.||||||0.071
73834409|NCT00421733|147217284|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA with treatment group as the factor and baseline FMV UACR as the covariate.||||||0.229
73834410|NCT00421733|147217284|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.||||||0.053
73834411|NCT00421733|147217285|SUPERIORITY_OR_OTHER|||||||0.102||95.0|||||Fisher Exact|||||||0.102
73834412|NCT00421733|147217285|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Fisher Exact|||||||0.038
73834413|NCT00421733|147217286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.855|TWO_SIDED|95.0|-0.26|0.22|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction||||0.22|-0.26|0.855
73834414|NCT00421733|147217286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33||||0.009|TWO_SIDED|95.0|-0.57|-0.08|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction||||-0.08|-0.57|0.009
73834415|NCT00421733|147217287|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.||||||<0.001
73834416|NCT00421733|147217287|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.||||||<0.001
73834417|NCT02810327|147217288|OTHER|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||The MUSC Bioinformatics Core analyzed group genomic data for variant association with COPD severity score, including single variant association or type of variant association with symptoms. Descriptive statistical analysis was performed using statistical package SAS 9.4 for Windows (SAS Institute Inc., Cary, NC, USA).||||0.054
73834418|NCT02265744|147217297|SUPERIORITY|||||||0.9745|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.9745
73834419|NCT02265744|147217297|SUPERIORITY|||||||0.6217|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.6217
73834420|NCT02265744|147217297|SUPERIORITY|||||||0.8295|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.8295
73834421|NCT02265744|147217297|SUPERIORITY|||||||0.9439|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.9439
73834422|NCT00299221|147217335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.4||0.44||95.0|||||t-test, 2 sided|||comparing ISHLT biopsy score between groups at 1 year||||0.44
73834423|NCT01086475|147217339|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
73834424|NCT01086475|147217340|SUPERIORITY_OR_OTHER|||||||0.927|||||||Chi-squared|||||||0.927
73834425|NCT01086475|147217341|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||t-test, 2 sided|||||||0.048
73834426|NCT00505362|147217342|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
73834427|NCT00505362|147217343|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
73834428|NCT02384460|147217344|OTHER||Hazard Ratio (HR)|1.004||||0.985|TWO_SIDED|95.0|0.651|1.549||p-value is for Type 3 chi-square test for comparison between treatments.|Cox Model Analysis|||Cox proportional hazards model compares treatment groups with baseline target wound size, target wound age, and EB type as covariates.||1.549|0.651|0.985
73834429|NCT02384460|147217345|OTHER|Multiple imputation was implemented by 2 steps. The first step used Markov Chain Monte Carlo (MCMC) to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 010005 and the number of imputations was 5.|Odds Ratio (OR)|0.733||||0.39|TWO_SIDED|95.0|0.365|1.474||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Comparison between treatment groups of complete closure of target wound within 3 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||1.474|0.365|0.39
73834430|NCT02384460|147217346|OTHER|Multiple imputation was implemented by 2 steps. The first step used MCMC to get the monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation method: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|1.633||||0.212|TWO_SIDED|95.0|0.758|3.517||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 1 visit. Comparison between treatment groups of complete closure of target wound within 1 month was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||3.517|0.758|0.212
73896687|NCT00955201|147326628|SUPERIORITY|||||||0.82||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.82
73896688|NCT00955201|147326628|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.96
73896689|NCT00955201|147326628|SUPERIORITY|||||||0.55|||||||ANOVA|||Comparison across groups at baseline.||||0.55
73834431|NCT02384460|147217346|OTHER|Multiple imputation was implemented by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|0.891||||0.802|TWO_SIDED|95.0|0.436|1.821||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 2 visit. Comparison between treatment groups of complete closure of target wound within 2 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||1.821|0.436|0.802
73834432|NCT02384460|147217347|OTHER|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.682||||0.706|TWO_SIDED|95.0|-2.873|4.238||The p-value is calculated based on the hypothesis testing for the difference of least-squares (LS)-means between treatment and placebo.|Mixed Models Analysis|||Mixed Model Repeated Measures (MMRM) Analysis. The MMRM approach (using restricted maximum likelihood \[REML\] estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.||4.238|-2.873|0.706
73834433|NCT02384460|147217348|OTHER|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.128||||0.9|TWO_SIDED|95.0|-2.116|1.861||The p-value is calculated based on the hypothesis testing for the difference of LS-means between treatment and placebo.|Mixed Models Analysis|||MMRM Analysis. The MMRM approach (using REML estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.||1.861|-2.116|0.9
73834434|NCT02384460|147217349|OTHER|Pre-specified.|Odds Ratio (OR)|1.445||||0.262|TWO_SIDED|95.0|0.759|2.752||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in itching versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline itching score, and EB type as covariates.||2.752|0.759|0.262
73834435|NCT02384460|147217350|OTHER|Pre-specified.|Odds Ratio (OR)|0.596||||0.098|TWO_SIDED|95.0|0.323|1.1||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in pain versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline pain score and EB type as covariates.||1.1|0.323|0.098
73834436|NCT01060111|147217351|SUPERIORITY_OR_OTHER|||||||0.6207|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.6207
73834437|NCT01060111|147217351|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferioirity was to be concluded if the ratio of percentage decrease in migraine episodes was greater than 0.7. Power of calculation was 0.9, significance level was 0.025.|Ratio of percentage decrease|0.95||||0.5|TWO_SIDED|95.0|0.519|1.737|||t-test, 1 sided|||||1.737|0.519|0.5
73834438|NCT01060111|147217352|SUPERIORITY_OR_OTHER|||||||0.7247|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.7247
73834439|NCT01060111|147217353|SUPERIORITY_OR_OTHER|||||||0.9872|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.9872
73834440|NCT01060111|147217354|SUPERIORITY_OR_OTHER|||||||0.4326||||||Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.|ANOVA|||||||0.4326
73834441|NCT01004393|147217362|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED||||||ANOVA|||||||0.161
73834442|NCT04999020|147217364|SUPERIORITY||Difference in response rates|-15.38||||0.4192|TWO_SIDED|80.0|-38.55|8.48|||Barnard's unconditional exact test|||||8.48|-38.55|0.4192
73834443|NCT02448043|147217380|SUPERIORITY|||||||0.532||||||Threshold is p\<0.05|t-test, 2 sided|||||||0.532
73834444|NCT02448043|147217381|SUPERIORITY|||||||0.523||||||Threshold is p\<0.05|t-test, 2 sided|||||||0.523
73834445|NCT02448043|147217382|SUPERIORITY|||||||0.912||||||Threshold is p\<0.05|t-test, 2 sided|||Comparing baseline values of both arms to completion values of both arms||||0.912
73834446|NCT02448043|147217383|SUPERIORITY|||||||0.062||||||Threshold is p\<0.05|t-test, 2 sided|||Comparison between baseline nail brittleness values and completion values||||0.062
73834447|NCT00997126|147217391|SUPERIORITY_OR_OTHER|||||||0.657|||||||Chi-squared|||||||0.657
73834448|NCT01327703|147217467|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval (CI) of Panzytrat® versus Kreon® exceeded -10%.|Treatment difference|-2.08||||0.459|TWO_SIDED|95.0|-7.23|4.02||As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Mixed Models Analysis|||Mixed model analysis method was used for comparison using log-transformed percent CFA as the response variable, fixed effect factors for treatment, period, treatment sequence and pooled site and participant within treatment sequence as a random effect.||4.02|-7.23|0.4590
73834449|NCT01860404|147217503|SUPERIORITY|||||||0.871|||||||Kruskal-Wallis|||||||0.871
73834450|NCT01860404|147217504|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||||||0.140
73834451|NCT01860404|147217505|SUPERIORITY|||||||0.267|||||||Kruskal-Wallis|||||||0.267
73834452|NCT01860404|147217506|SUPERIORITY|||||||0.476|||||||Kruskal-Wallis|||||||0.476
73834453|NCT01860404|147217507|SUPERIORITY|||||||0.581|||||||Kruskal-Wallis|||||||0.581
73834454|NCT01860404|147217508|SUPERIORITY|||||||0.203|||||||Fisher Exact|||||||0.203
73834455|NCT01860404|147217509|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
73834456|NCT01860404|147217510|SUPERIORITY|||||||0.482|||||||Kruskal-Wallis|||||||0.482
73834457|NCT01860404|147217511|SUPERIORITY|||||||0.393|||||||Kruskal-Wallis|||||||0.393
73834458|NCT01860404|147217512|SUPERIORITY|||||||0.629|||||||Kruskal-Wallis|||||||0.629
73834459|NCT01860404|147217513|SUPERIORITY|||||||0.624|||||||Regression, Linear|||||||0.624
73834460|NCT01860404|147217514|SUPERIORITY|||||||0.2554|||||||Regression, Linear|||||||0.2554
73834461|NCT01860404|147217515|SUPERIORITY|||||||0.7964|||||||Regression, Linear|||||||0.7964
73834462|NCT01860404|147217516|SUPERIORITY|||||||0.7749|||||||Regression, Linear|||||||0.7749
73834463|NCT01860404|147217517|SUPERIORITY|||||||0.0036|||||||Regression, Linear|||||||0.0036
73834464|NCT01860404|147217518|SUPERIORITY|||||||0.0053|||||||Regression, Linear|||||||0.0053
73834465|NCT01860404|147217519|SUPERIORITY|||||||0.8234|||||||Regression, Linear|||||||0.8234
73834466|NCT00849472|147217520|SUPERIORITY_OR_OTHER||Percentage of participants|17.98|||||TWO_SIDED|95.0|10.64|27.55|||||The estimated value (EV) represents the percentage of participants with pCR. Participants with missing data were excluded from the denominator (n=89; 4 participants with missing data) for the calculation of the EV.|||27.55|10.64|
73834467|NCT05259033|147217552|SUPERIORITY|Responses were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors and baseline HbA1c as covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.|Estimated treatment difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.33|||ANCOVA|||Treatment policy strategy||-0.33|-0.56|<0.0001
73834468|NCT04180696|147217558|SUPERIORITY|Endpoint for statistical analysis is the proportion Improved.||||||0.61|||||||Chi-squared|||||||0.61
73834469|NCT04180696|147217559|SUPERIORITY||Odds Ratio (OR)|1.192|STANDARD_ERROR_OF_MEAN|0.367||0.63|TWO_SIDED|95.0|0.579|2.455|||Regression, Logistic|Proportional odds logistic regression model. Baseline NYHA class and time included as fixed covariates.||Due to limited number of subjects with NYHA class III or IV during follow-up, class III, IV, and death were grouped as a single category for analysis.||2.455|0.579|0.63
73834470|NCT04180696|147217560|SUPERIORITY||Hazard Ratio (HR)|1.25|STANDARD_ERROR_OF_MEAN|0.476||0.64|TWO_SIDED|95.0|0.492|3.175|||Regression, Cox|Adjusted for NYHA class and sex.||||3.175|0.492|0.64
73834471|NCT04180696|147217561|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
73834472|NCT04180696|147217562|SUPERIORITY||Hazard Ratio (HR)|1.02|STANDARD_ERROR_OF_MEAN|0.817||0.98|TWO_SIDED|95.0|0.206|5.056|||Regression, Cox|||||5.056|0.206|0.98
73834473|NCT01405911|147217576|OTHER||Difference in Least Squares Means|-7.11|||<|0.001|TWO_SIDED|95.0|-9.85|-4.36|||Constrained Longitudinal Data Analysis|||||-4.36|-9.85|<0.001
73834474|NCT01405911|147217576|OTHER||Difference in Least Squares Means|-9.08|||<|0.001|TWO_SIDED|95.0|-11.82|-6.33|||Constrained Longitudinal Data Analysis|||||-6.33|-11.82|<0.001
73834475|NCT01405911|147217576|OTHER||Difference in Least Squares Means|-1.97||||0.143|TWO_SIDED|95.0|-4.61|0.67|||Constrained Longitudinal Data Analysis|||||0.67|-4.61|0.143
73834476|NCT01405911|147217577|OTHER||Difference in Least Squares Means|-17.7|||<|0.001|TWO_SIDED|95.0|-21.55|-13.86|||Constrained Longitudinal Data Analysis|||||-13.86|-21.55|<0.001
73834477|NCT01405911|147217577|OTHER||Difference in Least Squares Means|-16.41|||<|0.001|TWO_SIDED|95.0|-20.32|-12.5|||Constrained Longitudinal Data Analysis|||||-12.50|-20.32|<0.001
73834478|NCT01405911|147217577|OTHER||Difference in Least Squares Means|1.3||||0.469|TWO_SIDED|95.0|-2.22|4.82|||Constrained Longitudinal Data Analysis|||||4.82|-2.22|0.469
73834479|NCT01181479|147217581|EQUIVALENCE|Comparison of AG200-15 and Lessina for cycles 1-6.||||||0.067|||||||Chi-squared|||||||0.067
73834480|NCT01407367|147217637|OTHER||Hazard Ratio (HR)|0.38||||0.04|TWO_SIDED|95.0|0.16|0.94||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox|||||0.94|0.16|.04
73834481|NCT01407367|147217638|OTHER||Hazard Ratio (HR)|1.03||||0.86|TWO_SIDED|95.0|0.53|1.99||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox|||||1.99|0.53|0.86
73834482|NCT01271855|147217639|SUPERIORITY||Z-Score|0.93||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different pain scores. Other values would fail to reject the null hypothesis.|The null hypothesis is that there is no difference in the visual analogue pain score scale (VAS) between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.||||.35
73834483|NCT01271855|147217640|SUPERIORITY||Odds Ratio (OR)|1.88||||0.3|TWO_SIDED|95.0|0.57|6.21|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of taking additional pain medications between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.||6.21|0.57|.30
73834484|NCT01271855|147217641|SUPERIORITY||Z-Score|2.34||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different satisfaction scores. Other values fail to reject the null hypothesis|The null hypothesis is that there is no difference in the pain satisfaction score between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group at discharge||||.02
73834485|NCT01452347|147217642|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|74.22|STANDARD_ERROR_OF_MEAN|1.05||||95.0|68.08|80.91|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||80.91|68.08|
73896690|NCT00955201|147326628|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wks||||0.31
73896691|NCT00955201|147326628|SUPERIORITY|||||||0.32|||||||ANOVA|||Comparison across groups at 24-wks||||0.32
73896692|NCT00955201|147326629|SUPERIORITY|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.81
73896693|NCT00955201|147326629|SUPERIORITY|||||||0.92||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.92
73834486|NCT01452347|147217643|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|84.46|STANDARD_ERROR_OF_MEAN|1.11||||95.0|70.32|101.44|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||101.44|70.32|
73834487|NCT01452347|147217644|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|95.5|STANDARD_ERROR_OF_MEAN|1.05||||95.0|88.69|102.84|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||102.84|88.69|
73834488|NCT01452347|147217645|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|103.25|STANDARD_ERROR_OF_MEAN|1.11||||95.0|86.4|123.4|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||123.40|86.40|
73834489|NCT01452347|147217646|SUPERIORITY_OR_OTHER||||||<|0.001||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||<0.001
73834490|NCT01452347|147217647|SUPERIORITY_OR_OTHER|||||||0.05||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.05
73834491|NCT01452347|147217648|SUPERIORITY_OR_OTHER|||||||0.46||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.46
73834492|NCT01452347|147217649|SUPERIORITY_OR_OTHER|||||||0.65||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.65
73834493|NCT01022580|147217656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|TWO_SIDED||||||unadj GEE|||||||0.89
73834494|NCT01022580|147217657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|TWO_SIDED||||||unadj GEE|||||||0.33
73834495|NCT01500096|147217663|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.15
73834496|NCT01500096|147217663|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms||||0.73
73834497|NCT01500096|147217664|SUPERIORITY|||||||0.1329|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.1329
73834498|NCT01500096|147217664|SUPERIORITY|||||||0.1191|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.1191
73834499|NCT01500096|147217665|SUPERIORITY|||||||0.7454|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7454
73834500|NCT01500096|147217665|SUPERIORITY|||||||0.7391|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7391
73834501|NCT01500096|147217666|SUPERIORITY|||||||0.6818|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.6818
73834502|NCT01500096|147217666|SUPERIORITY|||||||0.0579|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.0579
73834503|NCT01500096|147217667|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.17
73834504|NCT01500096|147217667|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.51
73834505|NCT01500096|147217668|SUPERIORITY|||||||0.7884|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7884
73834506|NCT01500096|147217668|SUPERIORITY|||||||0.5532|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.5532
73834507|NCT01500096|147217669|SUPERIORITY|||||||0.9885|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.9885
73834508|NCT01500096|147217669|SUPERIORITY|||||||0.2898|||||||Wilcoxon (Mann-Whitney)|2 sides Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.2898
73834509|NCT01500096|147217670|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.||||0.60
73834510|NCT01500096|147217670|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.||||0.28
73834511|NCT01500096|147217670|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.||||0.41
73834512|NCT01500096|147217670|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.||||0.72
73834513|NCT01500096|147217670|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.||||0.34
73834514|NCT01500096|147217670|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.||||0.58
73834515|NCT01500096|147217671|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 5 are significantly different between arms.||||0.31
73834516|NCT01500096|147217671|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.71
73834517|NCT01500096|147217672|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.18
73834518|NCT01500096|147217672|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.19
73834519|NCT01500096|147217673|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.47
73834520|NCT01500096|147217673|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.41
73834521|NCT01734928|147217675|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.001|TWO_SIDED|95.0|0.49|0.77|||Based on Cox proportional hazards model|||||0.77|0.49|0.001
73834522|NCT01734928|147217676|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.571|TWO_SIDED|95.0|0.77|1.15|||Log Rank|The p-value is based on a stratified log-rank test with stratification factors as above Cox model.|Based on Cox proportional hazards model, comparing the hazard functions associated with treatment groups, stratified by age, prior number of anti-myeloma regimens, and beta-2 macroglobulin at Screening.|||1.15|0.77|0.571
73834523|NCT01734928|147217678|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.064|TWO_SIDED|95.0|0.56|1.02|||Unstratified log-rank test|The p-value is based on an unstratified log-rank test.|Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.02|0.56|0.064
73834524|NCT01778985|147217681|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
73834525|NCT01778985|147217682|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
73834526|NCT01778985|147217683|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
73834527|NCT01778985|147217684|SUPERIORITY_OR_OTHER|||||||0.088|||||||t-test, 2 sided|t(18)=1.78, p=0.088||||||0.088
73834528|NCT01778985|147217685|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73834529|NCT01778985|147217686|SUPERIORITY_OR_OTHER|||||||0.91||||||t(28)=0.11, p=0.91|t-test, 2 sided|||||||0.91
73834530|NCT01778985|147217687|SUPERIORITY_OR_OTHER|||||||0.1||||||t(18)=1.69, p=.10|t-test, 2 sided|||||||0.10
73834531|NCT01778985|147217688|SUPERIORITY_OR_OTHER|||||||0.02||||||t(10)=2.76, p=0.020|t-test, 2 sided|||||||0.020
73834532|NCT01778985|147217689|SUPERIORITY_OR_OTHER|||||||0.78||||||t(23)=0.28, p=0.78|t-test, 2 sided|||||||0.78
73834533|NCT01778985|147217690|SUPERIORITY_OR_OTHER|||||||0.51||||||t(28)=0.67, p=0.51|t-test, 2 sided|||||||0.51
73834534|NCT01778985|147217691|SUPERIORITY_OR_OTHER|||||||0.24||||||t(23)=1.23, p=0.24|t-test, 2 sided|||||||0.24
73834535|NCT01778985|147217692|SUPERIORITY_OR_OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
73834536|NCT01778985|147217693|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
73834537|NCT01778985|147217694|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
73834538|NCT01778985|147217695|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
73834539|NCT01778985|147217696|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
73834540|NCT01778985|147217697|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
73834541|NCT01778985|147217698|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
73834542|NCT01778985|147217699|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
73834543|NCT01778985|147217700|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1
73834544|NCT00835978|147217719|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.578||||0.0189|TWO_SIDED|95.0|1.017|2.448||A priori defined threshold for statistical significance was: alpha=0.10 (one-sided)|Cochran-Mantel-Haenszel|||ORR for the 2 treatment arms was compared with the Cochran-Mantel-Haenszel test stratified by ECOG performance status. The relative risk ratio estimator was used to contrast the treatment effects on the endpoint. Both a point estimate and a 2-sided 95% CI were calculated using a normal approximation.||2.448|1.017|0.0189
73834545|NCT00835978|147217720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.849||||0.2444|TWO_SIDED|95.0|0.535|1.348|||Log Rank|||||1.348|0.535|0.2444
73834546|NCT01363440|147217753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.19|||<|0.0001|TWO_SIDED|97.5|9.35|15.04|||ANCOVA|||||15.04|9.35|<.0001
73834547|NCT01363440|147217753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.45|||<|0.0001|TWO_SIDED|97.5|7.73|13.17|||ANCOVA|||||13.17|7.73|<.0001
73834548|NCT01363440|147217754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.9||||0.0001|TWO_SIDED|97.5|34.7|57.0|||Cochran-Mantel-Haenszel|||||57.0|34.7|.0001
73834549|NCT01363440|147217754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.8||||0.0001|TWO_SIDED|97.5|27.2|50.3|||Cochran-Mantel-Haenszel|||||50.3|27.2|.0001
73834550|NCT01363440|147217755|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.2|||<|0.0001|TWO_SIDED|97.5|24.1|44.4|||Cochran-Mantel-Haenszel|||||44.4|24.1|<0.0001
73834551|NCT01363440|147217755|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.3|||<|0.0001|TWO_SIDED|97.5|13.5|33.1|||Cochran-Mantel-Haenszel|||||33.1|13.5|<.0001
73834552|NCT01363440|147217756|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.7|||<|0.0001|TWO_SIDED|97.5|9.0|30.4|||Cochran-Mantel-Haenszel|||||30.4|9.0|<.0001
73834553|NCT01363440|147217756|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.9||||0.0017|TWO_SIDED|97.5|4.4|25.4|||Cochran-Mantel-Haenszel|||||25.4|4.4|0.0017
73834554|NCT01363440|147217757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-110.8|||<|0.0001|TWO_SIDED|97.5|-141.3|-80.22|||ANCOVA|||||-80.22|-141.3|<.0001
73834555|NCT01363440|147217757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-113.5|||<|0.0001|TWO_SIDED|97.5|-144.2|-82.75|||ANCOVA|||||-82.75|-144.2|<.0001
73834556|NCT01363440|147217758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.19||||0.0168||97.5|0.33|10.04|||ANCOVA|||||10.04|0.33|0.0168
73834557|NCT01363440|147217758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.36||||0.0323|TWO_SIDED|97.5|-0.21|8.93|||ANCOVA|||||8.93|-0.21|0.0323
73834558|NCT01363440|147217759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.86||||0.1702|TWO_SIDED|97.5|-1.82|7.54|||ANCOVA|||||7.54|-1.82|0.1702
73834559|NCT01363440|147217759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||0.4067|TWO_SIDED|97.5|-2.83|6.13|||ANCOVA|||||6.13|-2.83|0.4067
73834560|NCT01952678|147217822|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
73834561|NCT01952678|147217822|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.0||||0.4608|TWO_SIDED|95.0|-25.8|12.1|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.1|-25.8|0.4608
73834562|NCT01952678|147217822|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
73834563|NCT01952678|147217822|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
73834564|NCT01952678|147217823|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
73834565|NCT01952678|147217823|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.1||||0.4599|TWO_SIDED|95.0|-26.1|12.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.2|-26.1|0.4599
73834566|NCT01952678|147217823|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
73834567|NCT01952678|147217823|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
73834568|NCT01952678|147217824|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-22.0|22.0|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||22.0|-22.0|1.0000
73834569|NCT01952678|147217824|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.4||||1|TWO_SIDED|95.0|-20.8|20.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.8|-20.8|1.0000
73834570|NCT01952678|147217824|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-2.0||||1|TWO_SIDED|95.0|-23.0|18.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||18.5|-23.0|1.0000
73834571|NCT01952678|147217824|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.3||||1|TWO_SIDED|95.0|-20.8|20.8|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.8|-20.8|1.0000
73834572|NCT01952678|147217825|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-22.8|22.8|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||22.8|-22.8|1.0000
73834573|NCT01952678|147217825|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|5.2||||0.5187|TWO_SIDED|95.0|-16.7|26.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||26.2|-16.7|0.5187
73834574|NCT01952678|147217825|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.2||||1|TWO_SIDED|95.0|-21.5|21.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||21.5|-21.5|1.0000
73834575|NCT01952678|147217825|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.7||||0.7123|TWO_SIDED|95.0|-19.1|23.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||23.9|-19.1|0.7123
73834576|NCT01952678|147217826|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|TWO_SIDED|95.0|-13.3|15.3|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.3|-13.3|1.0000
73834577|NCT01952678|147217826|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-3.8||||0.5731|TWO_SIDED|95.0|-17.7|9.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||9.8|-17.7|0.5731
73834578|NCT01952678|147217826|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.1||||1|TWO_SIDED|95.0|-13.8|13.8|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||13.8|-13.8|1.0000
73896694|NCT00955201|147326629|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.93
73834579|NCT01952678|147217826|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.834|TWO_SIDED|95.0|-12.8|14.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||14.7|-12.8|0.8340
73834580|NCT01952678|147217827|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|TWO_SIDED|95.0|-13.5|15.6|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.6|-13.5|1.0000
73834581|NCT01952678|147217827|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-1.9||||0.8429|TWO_SIDED|95.0|-16.1|12.0|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.0|-16.1|0.8429
73834582|NCT01952678|147217827|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.8214|TWO_SIDED|95.0|-13.0|15.0|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.0|-13.0|0.8214
73834583|NCT01952678|147217827|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.2||||0.6577|TWO_SIDED|95.0|-12.0|16.1|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||16.1|-12.0|0.6577
73834584|NCT00845182|147217839|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
73834585|NCT00845182|147217839|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
73834586|NCT01625182|147217844|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9838|TWO_SIDED|95.0|0.6|1.7|||Regression, Cox|||||1.7|0.6|0.9838
73834587|NCT00447278|147217848|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.36|||<|0.001|TWO_SIDED|95.0|-6.47|-2.25||P-value for Change from Baseline at 6 Months. P-value is not adjusted and the threshold is 0.05.|Mixed Models Analysis|Mixed model repeated measure analysis with terms for corresponding baseline T-score, treatment, country, visit, and treatment-by-visit interaction.|Least Squares Mean Difference = Atomoxetine minus OEST.|||-2.25|-6.47|<0.001
73834588|NCT00447278|147217848|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.6|||<|0.001|TWO_SIDED|95.0|-6.56|-2.63||P-value for Change from Baseline: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-2.63|-6.56|<0.001
73834589|NCT00447278|147217849|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.1||||0.002|TWO_SIDED|95.0|-5.08|-1.13||P-value for Change from Baseline: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.13|-5.08|0.002
73834590|NCT00447278|147217850|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.04||||0.002|TWO_SIDED|95.0|-4.92|-1.15||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.15|-4.92|0.002
73834591|NCT00447278|147217850|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.1||||0.031|TWO_SIDED|95.0|-4.01|-0.2||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.20|-4.01|0.031
73834592|NCT00447278|147217850|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.55||||0.629|TWO_SIDED|95.0|-1.68|2.77||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.77|-1.68|0.629
73834593|NCT00447278|147217850|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96||||0.421|TWO_SIDED|95.0|-3.3|1.38||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.38|-3.30|0.421
73834594|NCT00447278|147217850|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.05||||0.388|TWO_SIDED|95.0|-3.44|1.34||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.34|-3.44|0.388
73834595|NCT00447278|147217850|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.29||||0.059|TWO_SIDED|95.0|-4.66|0.09||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.09|-4.66|0.059
73834596|NCT00447278|147217850|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.56||||0.006|TWO_SIDED|95.0|-6.09|-1.04||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.04|-6.09|0.006
73834597|NCT00447278|147217850|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.91||||0.027|TWO_SIDED|95.0|-5.49|-0.33||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.33|-5.49|0.027
73834598|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.073||||0.015|TWO_SIDED|95.0|0.014|0.131||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.131|0.014|0.015
73834599|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085||||0.004|TWO_SIDED|95.0|0.027|0.143||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.143|0.027|0.004
73834600|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.094||||0.063|TWO_SIDED|95.0|-0.005|0.192||P-value for Home Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.192|-0.005|0.063
73834601|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.075||||0.131|TWO_SIDED|95.0|-0.022|0.172||P-value for Home Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.172|-0.022|0.131
73834602|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.052||||0.156|TWO_SIDED|95.0|-0.02|0.124||P-value for Daily Living Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.124|-0.020|0.156
73834603|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.072||||0.046|TWO_SIDED|95.0|0.001|0.143||P-value for Daily Living Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.143|0.001|0.046
73834604|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.04||||0.068|TWO_SIDED|95.0|-0.003|0.084||P-value for Risk Taking Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.084|-0.003|0.068
73834605|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.028||||0.212|TWO_SIDED|95.0|-0.016|0.073||P-value for Risk Taking Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.073|-0.016|0.212
73834606|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.121||||0.006|TWO_SIDED|95.0|0.034|0.208||P-value for School Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.208|0.034|0.006
73834607|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|||<|0.001|TWO_SIDED|95.0|0.064|0.236||P-value for School Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.236|0.064|<0.001
73834608|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.125||||0.034|TWO_SIDED|95.0|0.009|0.24||P-value for Self-Concept Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.240|0.009|0.034
73834609|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.119||||0.04|TWO_SIDED|95.0|0.005|0.233||P-value for Self-Concept Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.233|0.005|0.040
73834610|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085||||0.042|TWO_SIDED|95.0|0.003|0.166||p-value for Social Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.166|0.003|0.042
73834611|NCT00447278|147217851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.048||||0.271|TWO_SIDED|95.0|-0.038|0.134||P-value for Social Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.134|-0.038|0.271
73834612|NCT00447278|147217852|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.307||||0.034|TWO_SIDED|95.0|0.173|4.44||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||4.440|0.173|0.034
73834613|NCT00447278|147217852|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.072||||0.005|TWO_SIDED|95.0|0.942|5.202||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||5.202|0.942|0.005
73834614|NCT00447278|147217852|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.721||||0.004|TWO_SIDED|95.0|0.544|2.899||P-value for Inattention Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.899|0.544|0.004
73834615|NCT00447278|147217852|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.269|||<|0.001|TWO_SIDED|95.0|1.086|3.453||P-value for Inattention Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||3.453|1.086|<0.001
73834616|NCT00447278|147217852|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.58||||0.298|TWO_SIDED|95.0|-0.515|1.676||P-value for Hyperactivity Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.676|-0.515|0.298
73834617|NCT00447278|147217852|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.865||||0.119|TWO_SIDED|95.0|-0.225|1.956||P-value for Hyperactivity Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.956|-0.225|0.119
73834618|NCT00447278|147217853|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.104||||0.366|TWO_SIDED|95.0|-0.122|0.329||P-value for Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.329|-0.122|0.366
73834619|NCT00447278|147217853|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.169||||0.165|TWO_SIDED|95.0|-0.07|0.407||P-value for Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.407|-0.070|0.165
73834620|NCT00447278|147217854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.35||||0.054|TWO_SIDED|95.0|-4.74|0.04||P-value for Achievement Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.04|-4.74|0.054
73834621|NCT00447278|147217854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.71||||0.003|TWO_SIDED|95.0|-6.16|-1.26||P-value for Achievement Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.26|-6.16|0.003
73834622|NCT00447278|147217854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.74||||0.033|TWO_SIDED|95.0|-3.33|-0.14||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.14|-3.33|0.033
73834623|NCT00447278|147217854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.5||||0.003|TWO_SIDED|95.0|-4.12|-0.88||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.88|-4.12|0.003
73834624|NCT00447278|147217854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5||||0.623|TWO_SIDED|95.0|-1.5|2.5||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.50|-1.50|0.623
73834625|NCT00447278|147217854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16||||0.88|TWO_SIDED|95.0|-1.96|2.29||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.29|-1.96|0.880
73834626|NCT00447278|147217854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4||||0.149|TWO_SIDED|95.0|-3.31|0.5||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.50|-3.31|0.149
73834627|NCT00447278|147217854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.78||||0.003|TWO_SIDED|95.0|-4.58|-0.98||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.98|-4.58|0.003
73834628|NCT00447278|147217854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.62||||0.015|TWO_SIDED|95.0|-4.71|-0.52||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.52|-4.71|0.015
73834629|NCT00447278|147217854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.12||||0.004|TWO_SIDED|95.0|-5.26|-0.98||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.98|-5.26|0.004
73834630|NCT00447278|147217855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.39||||0.263|TWO_SIDED|95.0|-1.83|6.6||P-value for Achievement Change at 4 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||6.60|-1.83|0.263
73834631|NCT00447278|147217855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.38||||0.848|TWO_SIDED|95.0|-3.6|4.36||P-value for Achievement Change at 6 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||4.36|-3.60|0.848
73834632|NCT00447278|147217855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19||||0.895|TWO_SIDED|95.0|-3.01|2.64||P-value for Statisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.64|-3.01|0.895
73834633|NCT00447278|147217855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.2||||0.038|TWO_SIDED|95.0|-6.22|-0.19||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.19|-6.22|0.038
73834634|NCT00447278|147217855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3||||0.854|TWO_SIDED|95.0|-3.59|2.98||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.98|-3.59|0.854
73834635|NCT00447278|147217855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.26||||0.161|TWO_SIDED|95.0|-5.45|0.92||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.92|-5.45|0.161
73834636|NCT00447278|147217855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7||||0.54|TWO_SIDED|95.0|-2.98|1.58||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.58|-2.98|0.540
73834637|NCT00447278|147217855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.98||||0.106|TWO_SIDED|95.0|-4.4|0.44||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.44|-4.40|0.106
73834638|NCT00447278|147217855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3||||0.833|TWO_SIDED|95.0|-2.49|3.08||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||3.08|-2.49|0.833
73834639|NCT00447278|147217855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.34||||0.11|TWO_SIDED|95.0|-5.21|0.54||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.54|-5.21|0.110
73834640|NCT01286324|147217872|SUPERIORITY|||||||0.21||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.21
73834641|NCT01286324|147217873|SUPERIORITY|||||||0.6||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.60
73834642|NCT01286324|147217874|SUPERIORITY|||||||0.47||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||Statistical Analysis for State Subscale||||0.47
73834643|NCT01286324|147217874|SUPERIORITY|||||||0.45||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||P-value for Trait Subscale||||0.45
73834644|NCT01286324|147217875|SUPERIORITY|||||||0.11||||||P value is adjusted based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.11
73834645|NCT05558410|147217891|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73834646|NCT05558410|147217892|SUPERIORITY|||||||0.2781|||||||ANCOVA|||||||0.2781
73834647|NCT05558410|147217893|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
73834648|NCT05558410|147217894|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
73834649|NCT05558410|147217895|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
73834650|NCT05558410|147217896|SUPERIORITY||||||<|0.0001|||||||Pearson's chi-squared test|||||||<0.0001
73834651|NCT05558410|147217897|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
73834652|NCT05558410|147217898|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
73834653|NCT05558410|147217899|SUPERIORITY|||||||0.0237|||||||Cochran-Mantel-Haenszel|||||||0.0237
73834654|NCT05558410|147217900|SUPERIORITY|||||||0.008|||||||Wilcoxon rank-sum|||||||0.0080
73834655|NCT03501277|147217940|EQUIVALENCE|Alogliptin: For each analyte, an analysis of variance (ANOVA) was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative bioavailability (BA) determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90 percent (%) confidence interval (CI) for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|Least Square Mean (LSM) difference|1.0706||||0.014|TWO_SIDED|90.0|1.023|1.1204|||ANOVA|||||1.1204|1.0230|0.014
73834656|NCT03501277|147217940|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0276||||0.326|TWO_SIDED|90.0|0.9817|1.0757|||ANOVA|||||1.0757|0.9817|0.326
73834657|NCT03501277|147217940|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM diiference|0.9594||||0.405|TWO_SIDED|90.0|0.8837|1.0415|||ANOVA|||||1.0415|0.8837|0.405
73834658|NCT03501277|147217940|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|0.9257||||0.124|TWO_SIDED|90.0|0.8523|1.0053|||ANOVA|||||1.0053|0.8523|0.124
73834659|NCT03501277|147217941|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0157||||0.081|TWO_SIDED|90.0|1.0009|1.0308|||ANOVA|||||1.0308|1.0009|0.081
73834660|NCT03501277|147217941|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0009||||0.922|TWO_SIDED|90.0|0.9862|1.0158|||ANOVA|||||1.0158|0.9862|0.922
73834661|NCT03501277|147217941|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0486||||0.066|TWO_SIDED|90.0|1.0051|1.0939|||ANOVA|||||1.0939|1.0051|0.066
73896695|NCT00955201|147326629|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
73896696|NCT00955201|147326629|SUPERIORITY|||||||0.5|||||||ANOVA|||Comparison across groups at baseline.||||0.50
73834662|NCT03501277|147217941|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0267||||0.308|TWO_SIDED|90.0|0.9839|1.0714|||ANOVA|||||1.0714|0.9839|0.308
73834663|NCT06038643|147217957|OTHER||||||<|0.001||||||Adjusted for multiple comparisons using False Discovery Rate.|Wilcoxon (Mann-Whitney)|||||||<0.001
73834664|NCT06038643|147217960|SUPERIORITY||||||<|0.01|||||||ANCOVA|||We conducted one-way analyses of covariance (ANCOVAs) to assess the effect of group (intervention vs. control) on post-intervention secondary outcomes, including cognition (Test My Brain Digital Neuropsychology Toolkit). Covariates in all models included age, sex, years of education, APOE4 status, and baseline scores.||||<0.01
73834665|NCT00963508|147217991|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
73834666|NCT00963508|147217992|SUPERIORITY_OR_OTHER|||||||0.0005|||||||t-test, 2 sided|||||||0.0005
73834667|NCT04739709|147217993|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834668|NCT04739709|147217994|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834669|NCT04739709|147217996|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834670|NCT04739709|147217997|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834671|NCT04739709|147217998|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834672|NCT04739709|147217999|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834673|NCT04739709|147218000|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834674|NCT04739709|147218001|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834675|NCT04739709|147218002|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834676|NCT04739709|147218003|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834677|NCT04739709|147218004|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-1.8|-1.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-1.3|-1.8|<0.001
73834678|NCT04739709|147218005|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.6|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.6|-0.9|<0.001
73834679|NCT04739709|147218006|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.8|-0.5|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.5|-0.8|<0.001
73834680|NCT04739709|147218007|SUPERIORITY||Mean Difference (Net)|-0.03||||0.017|TWO_SIDED|95.0|-0.06|-0.01|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.01|-0.06|0.017
73834681|NCT04739709|147218008|SUPERIORITY||Mean Difference (Net)|-0.07|||<|0.001|TWO_SIDED|95.0|-0.1|-0.04|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.04|-0.10|<0.001
73834682|NCT04739709|147218009|SUPERIORITY||Mean Difference (Net)|-0.09|||<|0.001|TWO_SIDED|95.0|-0.11|-0.06|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.06|-0.11|<0.001
73834683|NCT04739709|147218010|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
73834684|NCT00433290|147218033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 4 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
73834685|NCT00433290|147218033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 7 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
73834686|NCT00433290|147218033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 13 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
73834687|NCT00433290|147218034|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||ANCOVA|Model: PGI-Improvement=Treatment, Pooled Investigator, baseline severity and NSAID used for main effect p-values.||||||0.164
73834688|NCT00433290|147218035|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for Change from Baseline (change = endpoint - baseline)|ANCOVA|Model: Change=Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.016
73834689|NCT00433290|147218036|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.068
73834690|NCT00433290|147218037|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.064
73896697|NCT00955201|147326629|SUPERIORITY|||||||0.47|||||||ANOVA|||Comparison across groups at 12-wks.||||0.47
73896698|NCT00955201|147326629|SUPERIORITY|||||||0.97|||||||ANOVA|||Comparison across groups at 24-wks||||0.97
73896699|NCT00955201|147326630|SUPERIORITY|||||||0.83||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.83
73834691|NCT00433290|147218038|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Change in Weekly 24-Hour Average Pain. Change = endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.008
73834692|NCT00433290|147218038|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value for Change in Weekly 24-Hour Worst Pain. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.047
73834693|NCT00433290|147218039|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.009
73834694|NCT00433290|147218040|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73834695|NCT00433290|147218041|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-value for Mental Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.897
73834696|NCT00433290|147218041|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Physical Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||<0.001
73834697|NCT00433290|147218041|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Bodily Pain Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.004
73834698|NCT00433290|147218041|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for General Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.051
73834699|NCT00433290|147218041|SUPERIORITY_OR_OTHER|||||||0.508||95.0||||P-value for Mental Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.508
73834700|NCT00433290|147218041|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Physical Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.019
73834701|NCT00433290|147218041|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value for Role-Emotional Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.415
73834702|NCT00433290|147218041|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Role-Physical Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.006
73834703|NCT00433290|147218041|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-value for Social Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.342
73834704|NCT00433290|147218041|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for Vitality Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.135
73834705|NCT00433290|147218042|SUPERIORITY_OR_OTHER|||||||0.209||95.0||||P-value for EQ-5D Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change=Treament, Pooled Investigator, NSAID use and Baseline for main effect p-value.||||||0.209
73834706|NCT00433290|147218043|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.871
73834707|NCT00433290|147218044|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.138
73834708|NCT00433290|147218045|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.003
73834709|NCT00433290|147218046|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.015
73834710|NCT00433290|147218047|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||<0.001
73834711|NCT00433290|147218047|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for direct analgesic effect. The null hypothesis was tested by testing a1=0 versus a1≠0.|Regression, Linear|||Path analysis was used to test null hypothesis that change in BPI average pain severity depends on improvement of BDI or HADS-A, versus improvement in BPI average pain severity is due to a direct analgesic effect of treatment and not dependent on improvement in depression or anxiety symptoms. Model:Change in BPI average pain score=a0+a1\*treatment group+a2\*change in BDI total+a3\*change in HADS-A+a4\*BL of BPI average pain+a5\*BL of BDI total+a6\*BL of HADS-A.||||0.002
73834712|NCT00433290|147218048|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Change from Baseline. Change=Endpoint minus baseline.|ANCOVA|||||||0.007
73834713|NCT00433290|147218049|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.050
73834714|NCT00433290|147218050|SUPERIORITY_OR_OTHER|||||||0.913||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.913
73834715|NCT00433290|147218051|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.066
73834716|NCT00433290|147218052|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.001
73834717|NCT00433290|147218053|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.260
73834718|NCT00433290|147218054|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.489
73834719|NCT00433290|147218055|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.131
73834720|NCT00433290|147218056|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.082
73834721|NCT00433290|147218058|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Alkaline Phosphatase Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
73834722|NCT00433290|147218058|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for AST Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.010
73834723|NCT00433290|147218058|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for GGT Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.023
73834724|NCT00433290|147218059|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.042
73834725|NCT00433290|147218060|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.005
73834726|NCT00433290|147218061|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-value for SBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.285
73834727|NCT00433290|147218061|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for DBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.668
73834728|NCT00433290|147218062|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
73834729|NCT00433290|147218063|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||||||0.040
73834730|NCT03837938|147218071|NON_INFERIORITY|According to the protocol and SAP non-inferiority margin was defined as 20%.|Difference in rates Levopront®-Libexin®|5.81|||||ONE_SIDED|97.5|-7.17|||||||Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported|||-7.17|
73834731|NCT03837938|147218072|NON_INFERIORITY|According to the protocol and SAP non-inferiority margin was defined as 20%|difference in rates Levopront®-Libexin®|5.43|||||ONE_SIDED|97.5|-7.31|||||||Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported|||-7.31|
73834732|NCT03837938|147218073|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||>|0.999|||||||Fisher Exact|||||||>0.999
73834733|NCT03837938|147218074|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||=|0.861|||||||Fisher Exact|||||||=0.861
73834734|NCT03837938|147218075|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Daytime at Visit 2, Day 4||||<0.001
73834735|NCT03837938|147218075|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 2 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Daytime at Visit 3, Day 8||||<0.001
73834736|NCT03837938|147218075|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Nightime at Visit 2, Day 4||||<0.001
73834737|NCT03837938|147218075|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Nighttime at Visit 3, Day 8||||<0.001
73834738|NCT03837938|147218076|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Visit 2, Day 4||||<0.001
73834739|NCT03837938|147218076|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||at Visit 3, Day 8||||<0.001
73834740|NCT03837938|147218077|NON_INFERIORITY|non-inferiority margin is defined as 20%|||||=|0.336|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||||||=0.336
73834741|NCT01917773|147218081|NON_INFERIORITY_OR_EQUIVALENCE|"Reported MIs and SDs in healthy volunteers from an adult study were used to calculate sample size (1). A sample size of 13 patients was deemed adequate to detect a 25% change in MI with 80% power.~Reference: Rao SS, Kavelock R, Beaty J, Ackerson K, et al. Effects of fat and carbohydrate meals on colonic motor response. Gut. Feb 2000;46(2):205-211."||||||0.087|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 15 minutes. Values were considered to be significant if P \<0.05.||||0.087
73834742|NCT01917773|147218081|SUPERIORITY_OR_OTHER|||||||0.552|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 30 minutes. Values were considered to be significant if P \<0.05.||||0.552
73834743|NCT01917773|147218081|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 45 minutes. Values were considered to be significant if P \<0.05.||||0.807
73834744|NCT00504309|147218093|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|Tukey p-values were used for post hoc comparisons.||Fasting triglycerides (mg/dL) were measured on two consecutive days and averaged for analysis at the end of each treatment period. The null hypothesis was that triglycerides did not differ between groups.||||0.002
73834745|NCT00504309|147218093|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Mixed Models Analysis|||Cholesterol values were compared as the average of two fasting values at the end of each treatment. Cholesterol values included LDL-C, HDL-C, total cholesterol, and calculated ratios.||||> 0.05
73834746|NCT03345095|147218106|SUPERIORITY||Mean Difference (Net)|-6.4||||0.0004|TWO_SIDED|95.0|-8.6|-2.5|||Wilcoxon (Mann-Whitney)|||||-2.5|-8.6|0.0004
73834747|NCT03345095|147218107|SUPERIORITY||Mean Difference (Net)|-0.55||||0.15|TWO_SIDED|95.0|-1.27|0.16|||Wilcoxon (Mann-Whitney)|||||0.16|-1.27|0.15
73834748|NCT01121575|147218138|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|69.25|||||TWO_SIDED|90.0|54.22|88.44|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 11 participants. No statistical analysis was performed for PF-06260182.||88.44|54.22|
73834749|NCT01121575|147218139|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|78.84|||||TWO_SIDED|90.0|58.9|105.54|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUC10 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC10 was based on data from 6 participants. No statistical analysis was performed for PF-06260182.||105.54|58.90|
73834750|NCT01121575|147218141|SUPERIORITY_OR_OTHER||Ration of adjust geometric mean|70.6|||||TWO_SIDED|90.0|54.71|91.12|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 11 participants. No statistical analysis was performed for PF-06260182.||91.12|54.71|
73896700|NCT00955201|147326630|SUPERIORITY|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.91
73834751|NCT01121575|147218144|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|117.81|||||TWO_SIDED|90.0|64.97|213.61|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||213.61|64.97|
73834752|NCT01121575|147218145|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|121.9|||||TWO_SIDED|90.0|70.2|211.66|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUC24 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC24 was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||211.66|70.20|
73834753|NCT01121575|147218147|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|130.57|||||TWO_SIDED|90.0|82.46|206.73|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||206.73|82.46|
73834754|NCT00724503|147218155|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.551|TWO_SIDED|95.0|0.77|1.12|||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is rate of progression (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is PFS rate for SIRT/FOLFOX treatment lower to that of FOLFOX.||1.12|0.77|0.551
73834755|NCT00724503|147218156|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED|95.0|||||Log Rank|||A sample size of at least 450 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 12.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 530. The Null hypothesis is no difference between the treatment arms with respect to PFS.||||< 0.05
73834756|NCT01186419|147218159|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0765|TWO_SIDED||||||t-test, 2 sided|||||||0.0765
73834757|NCT01560416|147218164|SUPERIORITY|||||||0.79|||||||Log Rank|||||||0.79
73834758|NCT01560416|147218166|SUPERIORITY|||||||0.68|||||||Fisher Exact|||||||0.68
73834759|NCT00004859|147218184|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|95.0|||||Log Rank|||||||0.99
73834760|NCT03695094|147218205|OTHER||Geometric mean ratio|0.725|||||TWO_SIDED|90.0|0.586|0.896|||ANOVA|||The analysis of variance model (ANOVA) included the fixed effects of treatment group. The natural logs were taken of the dependent variables and were back-transformed after the analysis. The geometric mean ratio and the respective 90% confidence interval (CI) was derived for the Inducers group vs the Neutral-control group from the ANOVA model using least-squares means difference.||0.896|0.586|
73834761|NCT03695094|147218207|OTHER||Geometric mean ratio|0.636|||||TWO_SIDED|90.0|0.504|0.801|||ANOVA|||The analysis of variance model (ANOVA) included the fixed effects of treatment group. The natural logs were taken of the dependent variables and were back-transformed after the analysis. The geometric mean ratio and the respective 90% confidence interval (CI) was derived for the Inducers group vs the Neutral-control group from the ANOVA model using least-squares means difference.||0.801|0.504|
73834762|NCT00758043|147218262|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|4.5|||||TWO_SIDED|95.0|-2.1|11.1||||||Primary efficacy analysis was based on CI estimates (using the normal approximation, confidence limits were constructed for the difference in proportions) to rule out the inferiority of the T12/PR24/eRVR+ treatment regimen relative to the T12/PR48/eRVR+ treatment regimen. SVR24 was defined as undetectable HCV RNA at end of treatment through 24 weeks after the last planned dose.||11.1|-2.1|
73834763|NCT00758043|147218262|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.3|8.2||||||SVR24 was defined as below the limit of quantitation at 24 weeks after the planned end of treatment. For subjects who had missing data at week 24 after the planned end of treatment, the week 12 data or the last follow-up time point after week 12 was carried forward for determining SVR24.||8.2|-4.3|
73834764|NCT00758043|147218263|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Difference in Proportion|-0.5|||||TWO_SIDED|95.0|-7.7|6.8||||||||6.8|-7.7|
73834765|NCT00758043|147218263|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Odds Ratio, log|0.94|||||TWO_SIDED|95.0|0.49|1.82||||||||1.82|0.49|
73834766|NCT01579305|147218275|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is pre-defined as 15% i.e., if the difference in responder rates is significantly greater than -15% (i.e., the lower confidence limit is greater than -15%), statistical non-inferiority of VOLBELLA® to Restylane-L® is established.|Difference in responder rates|4.9|||||ONE_SIDED|97.5|-6.7||||||Difference in responder rates is calculated as the responder rate at Month 3 for VOLBELLA® minus the responder rate at Month 3 for Restylane-L®.|The null hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3, and the alternative hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3 with 15% pre-defined non-inferiority margin. To test the null hypothesis, a difference in responder rates of these products (VOLBELLA® - Restylane-L®) at Month 3 and a 1-sided 97.5% Wald confidence interval for the difference is calculated.|||-6.7|
73834767|NCT02400580|147218279|OTHER|||||||0.517|||||||Fisher Exact|||||||0.517
73834768|NCT02400580|147218281|OTHER|||||||0.508|||||||Fisher Exact|||||||0.508
73896701|NCT00955201|147326630|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
73896702|NCT00955201|147326630|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.95
73834769|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
73834770|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paited t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
73834771|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834772|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834773|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834774|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834775|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834776|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834777|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
73834778|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834779|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834780|NCT01336972|147218289|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834781|NCT01336972|147218290|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834782|NCT01336972|147218290|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834783|NCT01336972|147218290|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834784|NCT01336972|147218290|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834785|NCT01336972|147218290|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834786|NCT01336972|147218290|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834787|NCT01336972|147218290|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834788|NCT01336972|147218291|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834789|NCT01336972|147218291|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834790|NCT01336972|147218291|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834791|NCT01336972|147218291|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding||||>0.05
73834792|NCT01336972|147218291|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834793|NCT01336972|147218291|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834794|NCT01336972|147218291|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
73834795|NCT01336972|147218291|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
73834796|NCT01336972|147218292|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
73834797|NCT01336972|147218292|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
73834798|NCT01336972|147218292|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
73834799|NCT01336972|147218292|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||<0.05
73834800|NCT01336972|147218292|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Test to compare treatment groups at Final Treatment||||||>0.05
73834801|NCT01336972|147218292|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|paired t-test|||||||>0.05
73834802|NCT01336972|147218292|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
73834803|NCT01336972|147218292|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
73834804|NCT01336972|147218292|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
73834805|NCT01336972|147218292|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||<0.05
73834806|NCT01336972|147218296|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Comparison of all treatment groups versus Baseline at Final Treatment||||<0.05
73834807|NCT01336972|147218296|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Comparison of all treatment groups versus Baseline at Post Treatment||||<0.05
73834808|NCT01336972|147218296|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
73834809|NCT01336972|147218296|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
73834810|NCT01336972|147218296|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
73834811|NCT01336972|147218296|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
73834812|NCT01336972|147218296|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
73834813|NCT01336972|147218296|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
73834814|NCT01336972|147218297|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
73834815|NCT01336972|147218297|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
73834816|NCT01336972|147218297|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
73834817|NCT01336972|147218297|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
73834818|NCT01336972|147218297|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Paired t-test|||Test to compare PostTreatment versus Baseline for all treatment groups||||>0.05
73834819|NCT01336972|147218297|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
73834820|NCT01336972|147218297|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
73834821|NCT01336972|147218297|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||<0.05
73834822|NCT01336972|147218298|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired te-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
73834823|NCT01336972|147218298|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
73834824|NCT01336972|147218298|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
73834825|NCT01336972|147218298|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
73834826|NCT01336972|147218298|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||<0.05
73834827|NCT01336972|147218298|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
73834828|NCT01336972|147218298|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
73834829|NCT01336972|147218298|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
73834830|NCT01336972|147218298|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
73834831|NCT01336972|147218298|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
73834832|NCT03446573|147218313|NON_INFERIORITY|Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in virologic failure rates between the two treatment arms was smaller than 4%.|Adjusted difference in proportion (ADP)|-0.3|||||TWO_SIDED|95.0|-1.2|0.7|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor \[PI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and integrase inhibitor \[INI\]).|||0.7|-1.2|
73834833|NCT03446573|147218314|NON_INFERIORITY|Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded when the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms was greater than -8%.|Adjusted difference in proportion|0.2|||||TWO_SIDED|95.0|-3.4|3.9|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor: Baseline third agent (PI, NNRTI, and INSTI).|||3.9|-3.4|
73834834|NCT03446573|147218340|OTHER||Treatment ratio|1.057||||0.257|TWO_SIDED|95.0|0.96|1.164|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 24 has been presented.|||1.164|0.960|0.257
73834835|NCT03446573|147218340|OTHER||Treatment ratio|1.062||||0.35|TWO_SIDED|95.0|0.936|1.205|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 48 has been presented.|||1.205|0.936|0.350
73834836|NCT03446573|147218340|OTHER||Treatment ratio|0.979||||0.473|TWO_SIDED|95.0|0.924|1.037|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 24 has been presented.|||1.037|0.924|0.473
73834837|NCT03446573|147218340|OTHER||Treatment ratio|0.956||||0.212|TWO_SIDED|95.0|0.891|1.026|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 48 has been presented.|||1.026|0.891|0.212
73834838|NCT03446573|147218342|OTHER||Treatment ratio|0.977||||0.7|TWO_SIDED|95.0|0.866|1.102|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 96 has been presented.|||1.102|0.866|0.700
73834839|NCT03446573|147218342|OTHER||Treatment ratio|0.971||||0.7|TWO_SIDED|95.0|0.835|1.129|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 144 has been presented.|||1.129|0.835|0.700
73834840|NCT03446573|147218342|OTHER||Treatment ratio|0.969||||0.356|TWO_SIDED|95.0|0.907|1.036|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 96 has been presented.|||1.036|0.907|0.356
73834841|NCT03446573|147218342|OTHER||Treatment ratio|0.991||||0.814|TWO_SIDED|95.0|0.916|1.071|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 144 has been presented.|||1.071|0.916|0.814
73834842|NCT03446573|147218343|OTHER||Treatment ratio|0.958||||0.56|TWO_SIDED|95.0|0.83|1.106|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 24 has been presented.|||1.106|0.830|0.560
73834843|NCT03446573|147218343|OTHER||Treatment ratio|1.055||||0.489|TWO_SIDED|95.0|0.906|1.229|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 48 has been presented.|||1.229|0.906|0.489
73834844|NCT03446573|147218345|OTHER||Treatment ratio|1.165||||0.081|TWO_SIDED|95.0|0.981|1.384|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 96 has been presented.|||1.384|0.981|0.081
73834845|NCT03446573|147218345|OTHER||Treatment ratio|0.981||||0.834|TWO_SIDED|95.0|0.819|1.175|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 144 has been presented.|||1.175|0.819|0.834
73834846|NCT03446573|147218346|OTHER||Treatment ratio|1.017||||0.758|TWO_SIDED|95.0|0.915|1.13|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 24 has been presented.|||1.130|0.915|0.758
73834847|NCT03446573|147218346|OTHER||Treatment ratio|0.999||||0.985|TWO_SIDED|95.0|0.894|1.116|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 48 has been presented.|||1.116|0.894|0.985
73834848|NCT03446573|147218348|OTHER||Treatment ratio|1.015||||0.806|TWO_SIDED|95.0|0.904|1.139|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 96 has been presented.|||1.139|0.904|0.806
73834849|NCT03446573|147218348|OTHER||Treatment ratio|1.019||||0.745|TWO_SIDED|95.0|0.909|1.142|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 144 has been presented.|||1.142|0.909|0.745
73834850|NCT03446573|147218349|OTHER||Treatment ratio|0.935||||0.264|TWO_SIDED|95.0|0.83|1.052|||Mixed Model Reported Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 24 has been presented.|||1.052|0.830|0.264
73834851|NCT03446573|147218349|OTHER||Treatment ratio|0.996||||0.932|TWO_SIDED|95.0|0.903|1.098|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 48 has been presented.|||1.098|0.903|0.932
73834852|NCT03446573|147218351|OTHER||Treatment ratio|1.15||||0.011|TWO_SIDED|95.0|1.032|1.281|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 96 has been presented.|||1.281|1.032|0.011
73834853|NCT03446573|147218351|OTHER||Treatment ratio|1.007||||0.895|TWO_SIDED|95.0|0.905|1.121|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 144 has been presented.|||1.121|0.905|0.895
73834854|NCT03446573|147218359|OTHER||Mean Difference (Net)|0.29||||0.047|TWO_SIDED|95.0|0.0|0.57|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 24 has been presented|||0.57|0.00|0.047
73834855|NCT03446573|147218359|OTHER||Mean Difference (Net)|0.31||||0.094|TWO_SIDED|95.0|-0.05|0.68|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 48 has been presented|||0.68|-0.05|0.094
73834856|NCT03446573|147218359|OTHER||Mean Difference (Net)|-1.34|||<|0.001|TWO_SIDED|95.0|-2.01|-0.68|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 24 has been presented|||-0.68|-2.01|<0.001
73834857|NCT03446573|147218359|OTHER||Mean Difference (Net)|-1.84|||<|0.001|TWO_SIDED|95.0|-2.59|-1.09|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 48 has been presented|||-1.09|-2.59|<0.001
73834858|NCT03446573|147218359|OTHER||Mean Difference (Net)|2.1||||0.066|TWO_SIDED|95.0|-0.1|4.3|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 24 has been presented|||4.3|-0.1|0.066
73834859|NCT03446573|147218359|OTHER||Mean Difference (Net)|2.9||||0.046|TWO_SIDED|95.0|0.0|5.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 48 has been presented|||5.8|0.0|0.046
73834860|NCT03446573|147218359|OTHER||Mean Difference (Net)|0.0381||||0.005|TWO_SIDED|95.0|0.0117|0.0646|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 24 has been presented|||0.0646|0.0117|0.005
73834861|NCT03446573|147218359|OTHER||Mean Difference (Net)|0.0292||||0.032|TWO_SIDED|95.0|0.0025|0.0559|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 48 has been presented|||0.0559|0.0025|0.032
73834862|NCT03446573|147218361|OTHER||Mean Difference (Net)|0.17||||0.386|TWO_SIDED|95.0|-0.22|0.57|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 96 has been presented|||0.57|-0.22|0.386
73834863|NCT03446573|147218361|OTHER||Mean Difference (Net)|0.14||||0.573|TWO_SIDED|95.0|-0.34|0.61|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 144 has been presented|||0.61|-0.34|0.573
73834864|NCT03446573|147218361|OTHER||Mean Difference (Net)|-1.87|||<|0.001|TWO_SIDED|95.0|-2.7|-1.04|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 96 has been presented|||-1.04|-2.70|< 0.001
73834865|NCT03446573|147218361|OTHER||Mean Difference (Net)|-1.95|||<|0.001|TWO_SIDED|95.0|-2.77|-1.14|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 144 has been presented|||-1.14|-2.77|< 0.001
73834866|NCT03446573|147218361|OTHER||Mean Difference (Net)|2.1||||0.082|TWO_SIDED|95.0|-0.3|4.4|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 96 has been presented.|||4.4|-0.3|0.082
73834867|NCT03446573|147218361|OTHER||Mean Difference (Net)|0.4||||0.765|TWO_SIDED|95.0|-2.3|3.2|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 144 has been presented|||3.2|-2.3|0.765
73834868|NCT03446573|147218361|OTHER||Mean Difference (Net)|0.0151||||0.301|TWO_SIDED|95.0|-0.0136|0.0438|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 96 has been presented|||0.0438|-0.0136|0.301
73834869|NCT03446573|147218361|OTHER||Mean Difference (Net)|0.0126||||0.34|TWO_SIDED|95.0|-0.0133|0.0384|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 144 has been presented|||0.0384|-0.0133|0.340
73834870|NCT03446573|147218362|OTHER||Mean Difference (Net)|-2.2||||0.173|TWO_SIDED|95.0|-5.3|1.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 24 has been presented|||1.0|-5.3|0.173
73834871|NCT03446573|147218362|OTHER||Mean Difference (Net)|-2.3||||0.168|TWO_SIDED|95.0|-5.5|1.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 48 has been presented|||1.0|-5.5|0.168
73834872|NCT03446573|147218364|OTHER||Mean Difference (Net)|-9.4|||<|0.001|TWO_SIDED|95.0|-14.0|-4.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 96 has been presented.|||-4.7|-14.0|<0.001
73834873|NCT03446573|147218364|OTHER||Mean Difference (Net)|-5.6||||0.005|TWO_SIDED|95.0|-9.4|-1.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 144 has been presented.|||-1.7|-9.4|0.005
73834874|NCT03446573|147218365|OTHER||Mean Difference (Net)|-0.01||||0.027|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 24 has been presented|||0.00|-0.03|0.027
73834875|NCT03446573|147218365|OTHER||Mean Difference (Net)|-0.01||||0.061|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 48 has been presented|||0.00|-0.03|0.061
73834876|NCT03446573|147218367|OTHER||Mean Difference (Net)|-0.03||||0.004|TWO_SIDED|95.0|-0.06|-0.01|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 96 has been presented|||-0.01|-0.06|0.004
73834877|NCT03446573|147218367|OTHER||Mean Difference (Net)|-0.01||||0.094|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 144 has been presented|||0.00|-0.03|0.094
73834878|NCT03446573|147218368|OTHER||Mean Difference (Net)|1.8||||0.012|TWO_SIDED|95.0|0.4|3.1|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 24 has been presented|||3.1|0.4|0.012
73834879|NCT03446573|147218368|OTHER||Mean Difference (Net)|1.6||||0.059|TWO_SIDED|95.0|-0.1|3.3|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 48 has been presented|||3.3|-0.1|0.059
73834880|NCT03446573|147218368|OTHER||Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|95.0|-6.3|-3.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 24 has been presented|||-3.7|-6.3|<0.001
73834881|NCT03446573|147218368|OTHER||Mean Difference (Net)|-4.8|||<|0.001|TWO_SIDED|95.0|-6.1|-3.4|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 48 has been presented|||-3.4|-6.1|<0.001
73834882|NCT03446573|147218370|OTHER||Mean Difference (Net)|4.1||||0.002|TWO_SIDED|95.0|1.5|6.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 96 has been presented|||6.7|1.5|0.002
73834883|NCT03446573|147218370|OTHER||Mean Difference (Net)|1.9||||0.064|TWO_SIDED|95.0|-0.1|3.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 148 has been presented|||3.8|-0.1|0.064
73834884|NCT03446573|147218370|OTHER||Mean Difference (Net)|-5.2|||<|0.001|TWO_SIDED|95.0|-6.7|-3.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 96 has been presented|||-3.8|-6.7|<0.001
73834885|NCT03446573|147218370|OTHER||Mean Difference (Net)|-4.5|||<|0.001|TWO_SIDED|95.0|-6.2|-2.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 144 has been presented|||-2.8|-6.2|<0.001
73834886|NCT03446573|147218371|OTHER||Mean Difference (Net)|4.37|||<|0.001|TWO_SIDED|95.0|3.03|5.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 24 has been presented.|||5.70|3.03|<0.001
73834887|NCT03446573|147218371|OTHER||Mean Difference (Net)|4.49|||<|0.001|TWO_SIDED|95.0|3.18|5.81|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 48 has been presented.|||5.81|3.18|<0.001
73834888|NCT03446573|147218373|OTHER||Mean Difference (Net)|4.95|||<|0.001|TWO_SIDED|95.0|3.47|6.43|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 96 has been presented.|||6.43|3.47|<0.001
73834889|NCT03446573|147218373|OTHER||Mean Difference (Net)|4.08|||<|0.001|TWO_SIDED|95.0|2.32|5.85|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 144 has been presented.|||5.85|2.32|<0.001
73834890|NCT03446573|147218374|OTHER||Mean Difference (Net)|-0.0017||||0.741|TWO_SIDED|95.0|-0.0119|0.0085|||Mixed Model Repeated Measures||Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0085|-0.0119|0.741
73834891|NCT03446573|147218374|OTHER||Mean Difference (Net)|0.0015||||0.792|TWO_SIDED|95.0|-0.0094|0.0123|||Mixed Model Repeated Measures||Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0123|-0.0094|0.792
73834892|NCT03446573|147218375|OTHER||Mean Difference (Net)|0.0003||||0.965|TWO_SIDED|95.0|-0.0121|0.0126|||Mixed Model Repeated Measures||Week 96. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0126|-0.0121|0.965
73834893|NCT03446573|147218375|OTHER||Mean Difference (Net)|-0.0109||||0.12|TWO_SIDED|95.0|-0.0247|0.0029|||Mixed Model Repeated Measures||Week 144. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0029|-0.0247|0.120
73834894|NCT03446573|147218376|OTHER||Mean Difference (Net)|-0.1||||0.879|TWO_SIDED|95.0|-1.4|1.2|||Mixed Model Repeated Measures||Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||1.2|-1.4|0.879
73834895|NCT03446573|147218376|OTHER||Mean Difference (Net)|-0.5||||0.414|TWO_SIDED|95.0|-1.9|0.8|||Mixed Model Repeated Measures||Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.8|-1.9|0.414
73834896|NCT03446573|147218377|OTHER||Mean Difference (Net)|-1.2||||0.102|TWO_SIDED|95.0|-2.5|0.2|||Mixed Model Repeated Measures||Week 96. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.2|-2.5|0.102
73834897|NCT03446573|147218377|OTHER||Mean Difference (Net)|-1.3||||0.093|TWO_SIDED|95.0|-2.8|0.2|||Mixed Model Repeated Measures||Week 144. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.2|-2.8|0.093
73834898|NCT04270760|147218380|SUPERIORITY||Treatment difference|-70.51|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-75.12|-65.9||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Group 1 versus (vs) Group 5||-65.90|-75.12|<0.001
73896703|NCT00955201|147326630|SUPERIORITY|||||||0.26|||||||ANOVA|||Comparison across groups at baseline.||||0.26
73896704|NCT00955201|147326630|SUPERIORITY|||||||0.42|||||||ANOVA|||Comparison across groups at 12-wks||||0.42
73896705|NCT00955201|147326630|SUPERIORITY|||||||0.95|||||||ANOVA|||Comparison across groups at 24-wks.||||0.95
73896706|NCT00955201|147326631|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.96
73896707|NCT00955201|147326631|SUPERIORITY|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.53
73896708|NCT00955201|147326631|SUPERIORITY|||||||0.79||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.79
73896709|NCT00955201|147326631|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.94
73834899|NCT04270760|147218380|SUPERIORITY||Treatment difference|-97.38|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-101.98|-92.77||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Group 2 vs Group 5||-92.77|-101.98|<0.001
73834900|NCT04270760|147218380|SUPERIORITY||Treatment difference|-101.13|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-105.79|-96.47||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Group 3 vs Group 5||-96.47|-105.79|<0.001
73834901|NCT04270760|147218380|SUPERIORITY||Treatment difference|-100.49|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-105.16|-95.82|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Group 4 vs Group 5||-95.82|-105.16|< 0.001
73834902|NCT04270760|147218381|SUPERIORITY||Treatment difference|-68.47|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-74.27|-62.67|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Group 1 vs Group 5||-62.67|-74.27|<0.001
73834903|NCT04270760|147218381|SUPERIORITY||Treatment difference|-96.12|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-101.92|-90.33|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Group 2 vs Group 5||-90.33|-101.92|<0.001
73834904|NCT04270760|147218381|SUPERIORITY||Treatment difference|-100.88|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-106.74|-95.02|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Group 3 vs Group 5||-95.02|-106.74|<0.001
73834905|NCT04270760|147218381|SUPERIORITY||Treatment difference|-85.94|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-91.83|-80.06|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Group 4 vs Group 5||-80.06|-91.83|< 0.001
73834906|NCT04270760|147218382|SUPERIORITY||Treatment difference|-23.659|STANDARD_ERROR_OF_MEAN|5.874|<|0.001|TWO_SIDED|95.0|-35.176|-12.143|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 1 vs Group 5||-12.143|-35.176|<0.001
73834907|NCT04270760|147218382|SUPERIORITY||Treatment difference|-22.518|STANDARD_ERROR_OF_MEAN|5.875|<|0.001|TWO_SIDED|95.0|-34.036|-11.0|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 2 vs Group 5||-11.000|-34.036|<0.001
73834908|NCT04270760|147218382|SUPERIORITY||Treatment difference|-22.967|STANDARD_ERROR_OF_MEAN|5.962|<|0.001|TWO_SIDED|95.0|-34.656|-11.278|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 3 vs Group 5||-11.278|-34.656|<0.001
73834909|NCT04270760|147218382|SUPERIORITY||Treatment difference|-24.696|STANDARD_ERROR_OF_MEAN|5.969|<|0.001|TWO_SIDED|95.0|-36.399|-12.993|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 4 vs Group 5||-12.993|-36.399|< 0.001
73834910|NCT04270760|147218382|SUPERIORITY||Treatment difference|-24.856|STANDARD_ERROR_OF_MEAN|6.119|<|0.001|TWO_SIDED|95.0|-36.853|-12.859|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 1 vs Group 5||-12.859|-36.853|<0.001
73834911|NCT04270760|147218382|SUPERIORITY||Treatment difference|-21.594|STANDARD_ERROR_OF_MEAN|6.118|<|0.001|TWO_SIDED|95.0|-33.59|-9.598|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 2 vs Group 5||-9.598|-33.590|<0.001
73834912|NCT04270760|147218382|SUPERIORITY||Treatment difference|-27.421|STANDARD_ERROR_OF_MEAN|6.194|<|0.001|TWO_SIDED|95.0|-39.565|-15.277|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 3 vs Group 5||-15.277|-39.565|<0.001
73834913|NCT04270760|147218382|SUPERIORITY||Treatment difference|-27.021|STANDARD_ERROR_OF_MEAN|6.232|<|0.001|TWO_SIDED|95.0|-39.24|-14.801|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 4 vs Group 5||-14.801|-39.240|<0.001
73834914|NCT04270760|147218383|SUPERIORITY||Treatment difference|-18.89|STANDARD_ERROR_OF_MEAN|3.779|<|0.001|TWO_SIDED|95.0|-26.303|-11.477|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 1 vs Group 5||-11.477|-26.303|<0.001
73834915|NCT04270760|147218383|SUPERIORITY||Treatment difference|-16.696|STANDARD_ERROR_OF_MEAN|3.778|<|0.001|TWO_SIDED|95.0|-24.107|-9.284|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 2 vs Group 5||-9.284|-24.107|<0.001
73834916|NCT04270760|147218383|SUPERIORITY||Treatment difference|-17.635|STANDARD_ERROR_OF_MEAN|3.825|<|0.001|TWO_SIDED|95.0|-25.139|-10.131|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 3 vs Group 5||-10.131|-25.139|<0.001
73834917|NCT04270760|147218383|SUPERIORITY||Treatment difference|-18.772|STANDARD_ERROR_OF_MEAN|3.839|<|0.001|TWO_SIDED|95.0|-26.303|-11.241|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 4 vs Group 5||-11.241|-26.303|< 0.001
73834918|NCT04270760|147218383|SUPERIORITY||Treatment difference|-20.04|STANDARD_ERROR_OF_MEAN|4.443|<|0.001|TWO_SIDED|95.0|-28.757|-11.323|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 1 vs Group 5||-11.323|-28.757|<0.001
73834919|NCT04270760|147218383|SUPERIORITY||Treatment difference|-17.06|STANDARD_ERROR_OF_MEAN|4.442|<|0.001|TWO_SIDED|95.0|-25.774|-8.345|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 2 vs Group 5||-8.345|-25.774|<0.001
73834920|NCT04270760|147218383|SUPERIORITY||Treatment difference|-19.509|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-28.336|-10.682|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 3 vs Group 5||-10.682|-28.336|<0.001
73834921|NCT04270760|147218383|SUPERIORITY||Treatment difference|-21.839|STANDARD_ERROR_OF_MEAN|4.517|<|0.001|TWO_SIDED|95.0|-30.7|-12.979|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 4 vs Group 5||-12.979|-30.700|<0.001
73834922|NCT02070991|147218385|SUPERIORITY_OR_OTHER||Difference between maci. and placebo|10.08||||0.3372|TWO_SIDED|95.0|-15.07|33.26|||Fisher Exact|||||33.26|-15.07|0.3372
73834923|NCT02070991|147218386|SUPERIORITY_OR_OTHER||Treatment effect (ratio of geom. means)|0.77|||||TWO_SIDED|95.0|0.55|1.08||||||||1.08|0.55|
73834924|NCT02070991|147218387|SUPERIORITY_OR_OTHER||Treatment effect (ratio of geom. means)|0.93|||||TWO_SIDED|95.0|0.64|1.36||||||||1.36|0.64|
73834925|NCT02070991|147218388|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.3|||||TWO_SIDED|95.0|-4.3|4.9||||||||4.9|-4.3|
73834926|NCT02070991|147218389|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.7|||||TWO_SIDED|95.0|-2.2|3.6||||||||3.6|-2.2|
73834927|NCT02070991|147218390|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|-0.3|||||TWO_SIDED|95.0|-4.2|3.7||||||||3.7|-4.2|
73834928|NCT02070991|147218391|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.4|||||TWO_SIDED|95.0|0.11|0.69||||||||0.69|0.11|
73834929|NCT02070991|147218392|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|-0.4|||||TWO_SIDED|95.0|-4.5|3.6||||||||3.6|-4.5|
73834930|NCT00827242|147218393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.66||0.004||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.004
73834931|NCT00827242|147218394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.26||0.029||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.029
73834932|NCT00827242|147218395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.057||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.057
73834933|NCT00827242|147218396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.002||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS storage subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.002
73834934|NCT00827242|147218397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.43||0.02||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS voiding subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.020
73834935|NCT00827242|147218398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.233||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS nocturia question. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.233
73896710|NCT00955201|147326631|SUPERIORITY|||||||0.75|||||||ANOVA|||Comparison across groups at baseline||||0.75
73834936|NCT00827242|147218399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.013||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS QoL Index. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.013
73834937|NCT00827242|147218400|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate \[total IPSS \< 20\]; severe \[total IPSS \>= 20\]||||||0.021
73834938|NCT00827242|147218401|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate \[total IPSS \< 20\]; severe \[total IPSS \>= 20\]||||||0.009
73834939|NCT00827242|147218402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.49||0.146||95.0||||The p-value associates with LS Mean difference of changes from baseline to 1 week between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.146
73834940|NCT00827242|147218403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.003||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.003
73834941|NCT00827242|147218404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IIEF-EF domain score. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||<0.001
73834942|NCT00827242|147218405|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for Qmax. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA|||||||0.300
73834943|NCT00827242|147218408|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for PVR volume. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA|||||||0.500
73834944|NCT05987540|147218430|SUPERIORITY|||||||0.8125|||||||Wilcoxon matched-pairs signed rank|||||||.8125
73834945|NCT05987540|147218433|SUPERIORITY||||||>|0.9999|||||||Wilconxon matched-pairs signed rank test|||||||>0.9999
73834946|NCT00471107|147218434|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||Power analysis was based on WMS-III Word Lists performance. With an effect comparable to the effect on verbal fluency in an earlier study of left frontal TDCS in healthy subjects, it would require 10 subjects per group (30 total) for a significance level of 0.05 and 80% power.||||>0.05
73834947|NCT02030418|147218485|SUPERIORITY|"The primary safety hypothesis is:~H0: CFR ≤ 86% vs. H1: CFR \> 86% Where CFR is the Complication Free Rate. The CFR is estimated as a binomial proportion and the 95% confidence interval (CI) of CFR is calculated using the Clopper-Pearson exact method. The null hypothesis is rejected at the 2.5% significance level if the lower bound of this CI exceeds the Performance Goal (PG) of 86%."|binomial proportion|93.3|||<|0.001|TWO_SIDED|95.0|89.9|95.9|||1-sided exact test for binomial proporti|||||95.9|89.9|<0.001
73834948|NCT02030418|147218486|SUPERIORITY|"The primary effectiveness hypothesis is:~H0: Rate ≤ 85.0% vs. H1: Rate \> 85.0%~where Rate is the proportion of subjects experiencing success, and success is defined as: pacing threshold voltage ≤ 2.0 V at 0.4 ms at 6-month visit and sensed R-wave amplitude either ≥ 5.0 mV at the 6-month visit or ≥ value at implant."|binomial proportion|93.4|||<|0.001|TWO_SIDED|95.0|89.9|96.0||The null hypothesis is rejected at the 2.5% significance level if the lower bound of the CI exceeds the Performance Goal (PG) of 85%.|1-sided exact test for binomial proporti|||||96.0|89.9|<0.001
73834949|NCT02030418|147218487|OTHER|"The hypothesis is intended to test whether the mean slope is within 35% of 1. The hypothesis is stated as follows:~H0: absolute value (Mean Slope - 100%) ≥ equivalence margin, equal to 35%~H1: absolute value (Mean Slope - 100%) \< equivalence margin, equal to 35%~The calculation of slope for individual subjects in the CAEP exercise protocol is done by setting the y-intercept to zero."|Slope|0.83|STANDARD_DEVIATION|0.27||0.001|TWO_SIDED|95.0|0.73|0.93|||two 1-sided test (TOST)|||||0.93|0.73|0.001
73834950|NCT06100250|147218507|OTHER|Paired sample t-test, 2 sided|Mean Difference (Net)|0.82||||0.01|TWO_SIDED|||||A priori threshold for statistical significance = 0.05|Paired sample t-test, 2 sided|Degrees of freedom = 66|Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)|Null hypothesis = Mean difference between the paired STI-related knowledge scores (pre-intervention and post-intervention) is 0||||0.01
73834951|NCT06100250|147218509|OTHER|Paired sample t-test, 2 sided|Mean Difference (Net)|-1.29|||<|0.01|TWO_SIDED|||||A priori threshold for statistical significance = 0.05|Paired sample t-test, 2 sided|Degrees of freedom = 47|Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)|Null hypothesis = Mean difference between the paired self-efficacy for specimen self-collection scores (pre-intervention and post-intervention) is 0||||<0.01
73834952|NCT02021318|147218512|NON_INFERIORITY|Non-inferiority of roxadustat versus darbepoetin alfa, margin = -15% (non-inferiority is concluded if the lower limit of the 95% confidence interval of the difference was \>-15%).|Difference in percentage|11.51|||||TWO_SIDED|95.0|5.66|17.36||||||A generalized linear model as an approximation for the Miettinen and Nurminen method, adjusted for stratification factors (actual) was used to estimate the difference of proportions and 95% confidence interval.||17.36|5.66|
73834953|NCT02021318|147218513|NON_INFERIORITY|Non-Inferiority, margin = -0.75 (non-inferiority is concluded if the lower bound of the 95% CI of the least square mean difference (LSM) is \> -0.75 g/dL).|LSM Difference|0.015||||0.839|TWO_SIDED|95.0|-0.131|0.162|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.162|-0.131|0.839
73896711|NCT00955201|147326631|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks||||0.51
73896712|NCT00955201|147326631|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at 24-wks.||||0.63
73834954|NCT02021318|147218514|SUPERIORITY||LSM Difference|-0.403|||<|0.001|TWO_SIDED|95.0|-0.51|-0.296|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline LDL, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.296|-0.510|<0.001
73834955|NCT02021318|147218515|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.004|TWO_SIDED|95.0|0.26|0.78|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||0.78|0.26|0.004
73834956|NCT02021318|147218516|NON_INFERIORITY|Non-Inferiority, margin = -3 (non-inferiority is concluded if the lower bound of the 95% confidence interval of the LSM difference is \> -3 points).|LSM Difference|-1.284||||0.027|TWO_SIDED|95.0|-2.423|-0.145|||Mixed Models Analysis|||The model included treatment, visit (weeks 8, 12 and 28) visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PF, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.145|-2.423|0.027
73834957|NCT02021318|147218517|NON_INFERIORITY|Non-Inferiority, margin = -3 (non-inferiority is concluded if the lower bound of the 95% confidence interval of the LSM difference is \> -3 points).|LSM Difference|-0.457||||0.454|TWO_SIDED|95.0|-1.656|0.742|||Mixed Models Analysis|||The model included treatment, visit (weeks 8, 12 and 28), visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 VT, baseline Hb, baseline eGFR as continuous covariates.||0.742|-1.656|0.454
73834958|NCT02021318|147218518|NON_INFERIORITY|Non-Inferiority, margin = 1 mmHg (non-inferiority is concluded if the upper bound of the 95% confidence interval of the LSM difference is \< 1).|LSM Difference|-0.372||||0.547|TWO_SIDED|95.0|-1.587|0.842|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||0.842|-1.587|0.547
73834959|NCT02021318|147218519|NON_INFERIORITY|Non-inferiority (hazard ratio margin of 1.3). Non-Inferiority was declared if the upper bound of the 95% CI is below 1.3.|Hazard Ratio (HR)|0.83||||0.336|TWO_SIDED|95.0|0.56|1.22|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.22|0.56|0.336
73834960|NCT02021318|147218520|SUPERIORITY||LSM Difference|-0.136||||0.818|TWO_SIDED|95.0|-1.299|1.026|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||1.026|-1.299|0.818
73834961|NCT02021318|147218521|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.452|TWO_SIDED|95.0|0.6|1.26|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is lower than 1.||1.26|0.60|0.452
73834962|NCT02021318|147218522|SUPERIORITY||LSM Difference|0.038||||0.529|TWO_SIDED|95.0|-0.081|0.157|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.157|-0.081|0.529
73834963|NCT02021318|147218523|SUPERIORITY||Hazard Ratio (HR)|1.64|||<|0.001|TWO_SIDED|95.0|1.38|1.96|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.96|1.38|<0.001
73834964|NCT02021318|147218524|SUPERIORITY||Hazard Ratio (HR)|1.66|||<|0.001|TWO_SIDED|95.0|1.39|1.98|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.98|1.39|<0.001
73834965|NCT02021318|147218525|SUPERIORITY||LSM Difference|0.051||||0.478|TWO_SIDED|95.0|-0.091|0.194|||Mixed Models Analysis|||Weeks 28-36 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.194|-0.091|0.478
73834966|NCT02021318|147218525|SUPERIORITY||LSM Difference|-0.003||||0.969|TWO_SIDED|95.0|-0.149|0.143|||Mixed Models Analysis|||Weeks 44-52 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.143|-0.149|0.969
73834967|NCT02021318|147218525|SUPERIORITY||LSM Difference|0.009||||0.91|TWO_SIDED|95.0|-0.14|0.157|||Mixed Models Analysis|||Weeks 72-80 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.157|-0.140|0.910
73834968|NCT02021318|147218525|SUPERIORITY||LSM Difference|0.024||||0.775|TWO_SIDED|95.0|-0.14|0.188|||Mixed Models Analysis|||Weeks 96-104 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.188|-0.140|0.775
73834969|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.087||||0.086|TWO_SIDED|95.0|-0.012|0.185|||Mixed Models Analysis|||Week 1- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.185|-0.012|0.086
73834970|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.278|||<|0.001|TWO_SIDED|95.0|0.165|0.391|||Mixed Models Analysis|||Week 2- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.391|0.165|<0.001
73834971|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.435|||<|0.001|TWO_SIDED|95.0|0.284|0.586|||Mixed Models Analysis|||Week 4- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.586|0.284|<0.001
73896713|NCT00955201|147326632|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.98
73834972|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.422|||<|0.001|TWO_SIDED|95.0|0.254|0.59|||Mixed Models Analysis|||Week 6- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.590|0.254|<0.001
73834973|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.38|||<|0.001|TWO_SIDED|95.0|0.205|0.556|||Mixed Models Analysis|||Week 8- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.556|0.205|<0.001
73834974|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.155|0.505|||Mixed Models Analysis|||Week 10- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.505|0.155|<0.001
73834975|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.3||||0.001|TWO_SIDED|95.0|0.119|0.482|||Mixed Models Analysis|||Week 12- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.482|0.119|0.001
73834976|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.159||||0.079|TWO_SIDED|95.0|-0.018|0.336|||Mixed Models Analysis|||Week 14- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.336|-0.018|0.079
73834977|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.183||||0.044|TWO_SIDED|95.0|0.005|0.361|||Mixed Models Analysis|||Week 16- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.361|0.005|0.044
73834978|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.173||||0.037|TWO_SIDED|95.0|0.01|0.336|||Mixed Models Analysis|||Week 18- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.336|0.010|0.037
73834979|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.085||||0.319|TWO_SIDED|95.0|-0.083|0.253|||Mixed Models Analysis|||Week 20- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.253|-0.083|0.319
73834980|NCT02021318|147218526|SUPERIORITY||LSM Difference|-0.03||||0.709|TWO_SIDED|95.0|-0.19|0.129|||Mixed Models Analysis|||Week 22- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.129|-0.190|0.709
73834981|NCT02021318|147218526|SUPERIORITY||LSM Difference|-0.061||||0.45|TWO_SIDED|95.0|-0.219|0.097|||Mixed Models Analysis|||Week 24- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.097|-0.219|0.450
73834982|NCT02021318|147218526|SUPERIORITY||LSM Difference|-0.065||||0.44|TWO_SIDED|95.0|-0.231|0.101|||Mixed Models Analysis|||Week 28- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.101|-0.231|0.440
73834983|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.014||||0.874|TWO_SIDED|95.0|-0.157|0.184|||Mixed Models Analysis|||Week 32- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.184|-0.157|0.874
73834984|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.131||||0.132|TWO_SIDED|95.0|-0.039|0.302|||Mixed Models Analysis|||Week 36- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.302|-0.039|0.132
73834985|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.187||||0.024|TWO_SIDED|95.0|0.024|0.351|||Mixed Models Analysis|||Week 40- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.351|0.024|0.024
73834986|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.022||||0.807|TWO_SIDED|95.0|-0.153|0.197|||Mixed Models Analysis|||Week 44- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.197|-0.153|0.807
73834987|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.012||||0.89|TWO_SIDED|95.0|-0.16|0.185|||Mixed Models Analysis|||Week 48- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.185|-0.160|0.890
73834988|NCT02021318|147218526|SUPERIORITY||LSM Difference|-0.029||||0.746|TWO_SIDED|95.0|-0.201|0.144|||Mixed Models Analysis|||Week 52- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.144|-0.201|0.746
73834989|NCT02021318|147218526|SUPERIORITY||LSM Difference|-0.032||||0.715|TWO_SIDED|95.0|-0.202|0.139|||Mixed Models Analysis|||Week 56- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.139|-0.202|0.715
73834990|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.066||||0.463|TWO_SIDED|95.0|-0.11|0.242|||Mixed Models Analysis|||Week 60- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.242|-0.110|0.463
73834991|NCT02021318|147218526|SUPERIORITY||LSM Difference|-0.002||||0.987|TWO_SIDED|95.0|-0.187|0.184|||Mixed Models Analysis|||Week 64- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.184|-0.187|0.987
73834992|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.104||||0.251|TWO_SIDED|95.0|-0.074|0.281|||Mixed Models Analysis|||Week 68- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.281|-0.074|0.251
73834993|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.067||||0.473|TWO_SIDED|95.0|-0.117|0.251|||Mixed Models Analysis|||Week 72- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.251|-0.117|0.473
73834994|NCT02021318|147218526|SUPERIORITY||LSM Difference|-0.022||||0.813|TWO_SIDED|95.0|-0.204|0.16|||Mixed Models Analysis|||Week 76- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.160|-0.204|0.813
73834995|NCT02021318|147218526|SUPERIORITY||LSM Difference|-0.045||||0.622|TWO_SIDED|95.0|-0.223|0.134|||Mixed Models Analysis|||Week 80- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.134|-0.223|0.622
73834996|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.045||||0.632|TWO_SIDED|95.0|-0.138|0.227|||Mixed Models Analysis|||Week 84- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.227|-0.138|0.632
73834997|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.055||||0.568|TWO_SIDED|95.0|-0.133|0.242|||Mixed Models Analysis|||Week 88- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.242|-0.133|0.568
73834998|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.034||||0.729|TWO_SIDED|95.0|-0.158|0.226|||Mixed Models Analysis|||Week 92- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.226|-0.158|0.729
73834999|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.025||||0.797|TWO_SIDED|95.0|-0.168|0.218|||Mixed Models Analysis|||Week 96- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.218|-0.168|0.797
73835000|NCT02021318|147218526|SUPERIORITY||LSM Difference|-0.11||||0.28|TWO_SIDED|95.0|-0.31|0.09|||Mixed Models Analysis|||Week 100- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.090|-0.310|0.280
73835001|NCT02021318|147218526|SUPERIORITY||LSM Difference|0.037||||0.733|TWO_SIDED|95.0|-0.177|0.251|||Mixed Models Analysis|||Week 104- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.251|-0.177|0.733
73835002|NCT02021318|147218527|SUPERIORITY||LSM Difference|0.026||||0.727|TWO_SIDED|95.0|-0.119|0.17|||Mixed Models Analysis|||Weeks 28-36 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.170|-0.119|0.727
73835003|NCT02021318|147218527|SUPERIORITY||LSM Difference|-0.001||||0.985|TWO_SIDED|95.0|-0.151|0.148|||Mixed Models Analysis|||Weeks 44-52 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.148|-0.151|0.985
73835004|NCT02021318|147218527|SUPERIORITY||LSM Difference|0.003||||0.965|TWO_SIDED|95.0|-0.148|0.154|||Mixed Models Analysis|||Weeks 72-80 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.154|-0.148|0.965
73835005|NCT02021318|147218527|SUPERIORITY||LSM Difference|-0.016||||0.856|TWO_SIDED|95.0|-0.188|0.157|||Mixed Models Analysis|||Weeks 96-104 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.157|-0.188|0.856
73835006|NCT02021318|147218529|SUPERIORITY||Hazard Ratio (HR)|1.74|||<|0.001|TWO_SIDED|95.0|1.36|2.22|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates.||2.22|1.36|<0.001
73835007|NCT02021318|147218532|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.079|TWO_SIDED|95.0|0.98|1.5|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||1.50|0.98|0.079
73835008|NCT02021318|147218533|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.3|TWO_SIDED|95.0|0.79|2.11|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||2.11|0.79|0.300
73835009|NCT02021318|147218537|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.055|TWO_SIDED|95.0|0.99|2.54|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||2.54|0.99|0.055
73835010|NCT02021318|147218540|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.052|TWO_SIDED|95.0|0.51|1.0|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI is below 1.0.||1.00|0.51|0.052
73835011|NCT02021318|147218550|SUPERIORITY||LSM Difference|-1.068||||0.027|TWO_SIDED|95.0|-2.012|-0.124|||Mixed Models Analysis|||Weeks 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.124|-2.012|0.027
73835012|NCT02021318|147218550|SUPERIORITY||LSM Difference|-0.603||||0.239|TWO_SIDED|95.0|-1.606|0.401|||Mixed Models Analysis|||Weeks 36-52 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||0.401|-1.606|0.239
73835013|NCT02021318|147218551|SUPERIORITY||LSM Difference|-0.528||||0.517|TWO_SIDED|95.0|-2.127|1.072|||Mixed Models Analysis|||Weeks 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An AnS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||1.072|-2.127|0.517
73835014|NCT02021318|147218551|SUPERIORITY||LSM Difference|-0.947||||0.308|TWO_SIDED|95.0|-2.771|0.877|||Mixed Models Analysis|||Weeks 36-52 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An AnS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||0.877|-2.771|0.308
73835015|NCT02021318|147218552|SUPERIORITY||LSM Difference|-0.904||||0.57|TWO_SIDED|95.0|-4.032|2.224|||Mixed Models Analysis|||Week 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An total score, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||2.224|-4.032|0.570
73835016|NCT02021318|147218552|SUPERIORITY||LSM Difference|-1.767||||0.334|TWO_SIDED|95.0|-5.354|1.82|||Mixed Models Analysis|||Weeks 36-52 -The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An total score, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||1.820|-5.354|0.334
73835017|NCT02021318|147218554|SUPERIORITY||LSM Difference|0.784||||0.497|TWO_SIDED|95.0|-1.481|3.049|||Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline EQ-5D 5L VAS, baseline Hb, baseline eGFR as continuous covariates.||3.049|-1.481|0.497
73835018|NCT02021318|147218565|SUPERIORITY||LSM Difference|-0.05||||0.902|TWO_SIDED|95.0|-0.93|0.82|||Mixed Models Analysis|||||0.82|-0.93|0.902
73835019|NCT02021318|147218567|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96|TWO_SIDED|95.0|0.79|1.29|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.29|0.79|0.960
73835020|NCT02021318|147218569|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.939|TWO_SIDED|95.0|0.79|1.25|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.25|0.79|0.939
73835021|NCT02021318|147218570|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.948|TWO_SIDED|95.0|0.77|1.27|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.27|0.77|0.948
73835022|NCT02021318|147218571|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.568|TWO_SIDED|95.0|0.75|1.17|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.17|0.75|0.568
73835023|NCT05762744|147218615|OTHER|Unpaired two-tailed t-test to test null hypothesis||||||0.37||||||The t-test was conducted on the logarithms of the variable.|t-test, 2 sided|||Null hypothesis: the order of FSIGTs (saline or exenatide-stimulated) does not affect the response during an FSIGT||||0.37
73835024|NCT05762744|147218616|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.66|||||||t-test, 2 sided|||Null hypothesis: The order of FSIGT (exenatide-stimulated or saline) does not affect the response to an FSIGT.||||0.66
73835025|NCT05762744|147218617|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.55|||||||t-test, 2 sided|||Null hypothesis: the order of testing (exenatide-stimulated or saline FSIGT) does not affect data obtained in the FSIGTs.||||0.55
73835026|NCT05762744|147218618|OTHER|Unpaired, two-tailed t-test to test the null hypothesis||||||0.45|||||||t-test, 2 sided|||The order of FSIGTs (exenatide-stimulated or saline) does not affect the response during an FSIGT||||0.45
73835027|NCT05762744|147218619|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.86||||||The t-test was conducted on the logarithms of the variable|t-test, 2 sided|||Null hypothesis: the order of FSIGT (exenatide or saline) does not affect the response during an FSIGT||||0.86
73835028|NCT05762744|147218620|OTHER|Two-tailed p-test for unpaired data||||||0.44||||||The t-test was conducted on the logarithms of the variable.|t-test, 2 sided|||Null hypothesis: The order of FSIGTs (exenatide-stimulated or saline) does not affect the response to an FSIGT||||0.44
73835029|NCT05762744|147218621|OTHER|||||||0.41|||||||t-test, 2 sided|||"Null hypothesis: no differences between the two groups with respect to exenatide's effect on first-phase insulin secretion.~t-test conducted on logarithms of the values"||||0.41
73835030|NCT05762744|147218621|OTHER|||||||0.38|||||||t-test, 2 sided|||Null hypothesis: no difference between two groups with respect to exenatide's effect on first phase insulin secretion||||0.38
73835031|NCT05762744|147218622|OTHER|||||||0.8|||||||t-test, 2 sided|||Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance||||0.80
73835032|NCT05762744|147218622|OTHER|||||||0.98|||||||t-test, 2 sided|||Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance during an FSIGT||||0.98
73835033|NCT00441896|147218677|SUPERIORITY|||||||0.7391|||||||ANCOVA|||||||0.7391
73835034|NCT00441896|147218677|SUPERIORITY|||||||0.537|||||||ANCOVA|||||||0.5370
73835035|NCT00441896|147218677|SUPERIORITY|||||||0.908|||||||ANCOVA|||||||0.9080
73835036|NCT00441896|147218677|SUPERIORITY|||||||0.2539|||||||ANCOVA|||||||0.2539
73835037|NCT00441896|147218677|SUPERIORITY|||||||0.6657|||||||ANCOVA|||||||0.6657
73835038|NCT00441896|147218678|SUPERIORITY|||||||0.4249|||||||ANCOVA|||||||0.4249
73835039|NCT00441896|147218678|SUPERIORITY|||||||0.4177|||||||ANCOVA|||||||0.4177
73835040|NCT00441896|147218678|SUPERIORITY|||||||0.3033|||||||ANCOVA|||||||0.3033
73835041|NCT00441896|147218678|SUPERIORITY|||||||0.3014|||||||ANCOVA|||||||0.3014
73835042|NCT00441896|147218678|SUPERIORITY|||||||0.1839|||||||ANCOVA|||||||0.1839
73835043|NCT01301092|147218686|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.443|||||TWO_SIDED|90.0|0.395|0.497|||Mixed Linear effects model analyses|||||0.497|0.395|
73835044|NCT01301092|147218687|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|2.1|||||TWO_SIDED|90.0|1.84|2.41|||Mixed Linear effects model analyses|||||2.41|1.84|
73835045|NCT01301092|147218688|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|0.962|||||TWO_SIDED|90.0|0.858|1.08|||Mixed Linear effects model analyses|||||1.08|0.858|
73835046|NCT01301092|147218689|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.05|||||TWO_SIDED|90.0|0.924|1.19|||Mixed Linear effects model analyses|||||1.19|0.924|
73835047|NCT01350973|147218698|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.876|TWO_SIDED|95.0|-4.2491|4.983||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA|||||4.9830|-4.2491|0.8760
73835048|NCT01350973|147218698|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.35|||<|0.0001|TWO_SIDED|95.0|-15.9442|-6.7637||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA|||||-6.7637|-15.9442|< 0.0001
73835049|NCT02507284|147218709|NON_INFERIORITY|Results for the secondary safety endpoint, adverse events (AEs) in study subjects, was performed using a test for non-inferiority with a threshold of 0.50. The null hypothesis is that the treatment minus placebo proportion difference is greater than (or equal to) the margin of 0.50 and the alternative hypothesis is that the difference is less than 0.50.|Risk Ratio (RR)|0.025||||0.5|ONE_SIDED|97.5|||||t-test, 1 sided|||||||0.50
73835050|NCT03738215|147218710|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.005|TWO_SIDED|95.0|-4.17|-0.89||Adjusted P-Value (based on truncated Hochberg with parameter=0.9)|MMRM|MMRM = mixed-effects model for repeated measures||||-0.89|-4.17|0.0050
73835051|NCT03738215|147218710|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.0727|TWO_SIDED|95.0|-3.16|0.12||Adjusted P-Value (based on truncated Hochberg with parameter=0.9)|MMRM|MMRM = mixed-effects model for repeated measures||||0.12|-3.16|0.0727
73835052|NCT03738215|147218711|SUPERIORITY||Lease Squares Mean Difference|-0.3||||0.0727|TWO_SIDED|95.0|-0.49|-0.07||Adjusted P-Value (based on Hochberg procedure)|MMRM|MMRM = mixed-effects model for repeated measures||||-0.07|-0.49|0.0727
73835053|NCT03738215|147218711|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.0944|TWO_SIDED|95.0|-0.39|0.03||Adjusted P-Value (based on Hochberg procedure)|MMRM|MMRM = mixed-effects model for repeated measures.||||0.03|-0.39|0.0944
73835054|NCT01033071|147218720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|||<|0.001||95.0|-7.6|-3.1||"Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of all treatment groups equal first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level."|ANCOVA|||Analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate.||-3.1|-7.6|<0.001
73835055|NCT01033071|147218720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||<|0.001|TWO_SIDED|95.0|-9.2|-4.6||"Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of all treatment groups equal first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level."|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.6|-9.2|<0.001
73835056|NCT01033071|147218723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|||<|0.001|TWO_SIDED|95.0|-9.4|-4.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.7|-9.4|<0.001
73835057|NCT01033071|147218723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-11.5|-6.6||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-6.6|-11.5|<0.001
73835058|NCT01033071|147218725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|||<|0.001|TWO_SIDED|95.0|-8.5|-4.3||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.3|-8.5|<0.001
73835059|NCT01033071|147218725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.0|-6.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-6.7|-11.0|<0.001
73835060|NCT03277274|147218755|OTHER|TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.579|||||||ANOVA|||||||0.579
73835061|NCT03277274|147218755|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.026|||||||ANOVA|||||||0.026
73835062|NCT03277274|147218755|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.02|||||||ANOVA|||||||0.020
73835063|NCT03277274|147218755|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.031|||||||ANOVA|||||||0.031
73835064|NCT03277274|147218756|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.151|||||||ANOVA|||||||0.151
73835065|NCT03277274|147218756|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.017|||||||ANOVA|||||||0.017
73835066|NCT03277274|147218756|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.129|||||||ANOVA|||||||0.129
73835067|NCT03277274|147218756|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA|||||||0.023
73835068|NCT03277274|147218757|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.138|||||||ANOVA|||||||0.138
73835069|NCT03277274|147218757|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.029|||||||ANOVA|||||||0.029
73835070|NCT03277274|147218757|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.201|||||||ANOVA|||||||0.201
73835071|NCT03277274|147218757|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA|||||||0.023
73835072|NCT01258855|147218812|OTHER|||||||0.002|||||||Log Rank|||||||0.002
73835073|NCT01258855|147218813|OTHER|||||||0.43|||||||Log Rank|||||||0.43
73835074|NCT01258855|147218816|OTHER|||||||0.003|||||||Log Rank|||||||0.003
73835075|NCT01258855|147218817|OTHER|||||||0.02|||||||Log Rank|||||||0.02
73835076|NCT01567085|147218819|OTHER|Exact binomial test|||||<|0.001||||||The p-value was calculated from an exact binomial test, where the null hypothesis was that the true failure rate = 40%.|Exact binomial test|Exact 95% confidence interval (3.6, 17.2)||Analysis of post-transplantation treatment failure rate||||< 0.001
73835077|NCT03928704|147218831|SUPERIORITY||Odds Ratio (OR)|3.51|||<|0.001|TWO_SIDED|95.0|2.0|6.16|||Regression, Logistic|||||6.16|2.00|<0.001
73835078|NCT03928704|147218832|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.71|5.54|||Regression, Logistic|||||5.54|1.71|<0.001
73835079|NCT03928704|147218833|SUPERIORITY||LS Mean difference|-1.51|||<|0.001||95.0|-2.04|-0.98|||ANCOVA|||||-0.98|-2.04|<0.001
73835080|NCT03928704|147218833|SUPERIORITY||LS Mean difference|-0.91||||0.22|TWO_SIDED|95.0|-2.42|0.61|||ANCOVA|||||0.61|-2.42|0.220
73835081|NCT03928704|147218834|SUPERIORITY||Odds Ratio (OR)|3.69|||<|0.001|TWO_SIDED|95.0|2.17|6.26|||Regression, Logistic|||||6.26|2.17|<0.001
73835082|NCT03928704|147218835|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.001|TWO_SIDED|95.0|2.06|9.93|||Regression, Logistic|||||9.93|2.06|<0.001
73835083|NCT03928704|147218836|SUPERIORITY||Odds Ratio (OR)|5.43|||<|0.001|TWO_SIDED|95.0|2.41|12.23|||Regression, Logistic|||||12.23|2.41|<0.001
73835084|NCT03928704|147218837|SUPERIORITY||Odds Ratio (OR)|3.31|||<|0.001|TWO_SIDED|95.0|1.87|5.84|||Regression, Logistic|||||5.84|1.87|<0.001
73835085|NCT03928704|147218838|SUPERIORITY||LS Mean difference|-1.48|||<|0.001||95.0|-1.99|-0.97|||ANCOVA|||||-0.97|-1.99|<0.001
73835086|NCT03928704|147218838|SUPERIORITY||LS Mean difference|-1.25||||0.019|TWO_SIDED|95.0|-2.26|-0.24|||ANCOVA|||||-0.24|-2.26|0.019
73835087|NCT03928704|147218839|SUPERIORITY||LS Mean difference|-1.8|||<|0.001||95.0|-2.42|-1.18|||ANCOVA|||||-1.18|-2.42|<0.001
73835088|NCT03928704|147218839|SUPERIORITY||LS Mean difference|-1.09||||0.199|TWO_SIDED|95.0|-2.83|0.65|||ANCOVA|||||0.65|-2.83|0.199
73835089|NCT03928704|147218840|SUPERIORITY||LS Mean difference|-2.63|||<|0.001||95.0|-3.66|-1.61|||ANCOVA|||||-1.61|-3.66|<0.001
73835090|NCT03928704|147218840|SUPERIORITY||LS Mean difference|-1.84||||0.17|TWO_SIDED|95.0|-4.56|0.89|||ANCOVA|||||0.89|-4.56|0.170
73835091|NCT03928704|147218841|SUPERIORITY||LS Mean difference|3.96|||<|0.001|TWO_SIDED|95.0|2.08|5.83|||ANCOVA|||||5.83|2.08|<0.001
73835092|NCT03928704|147218841|SUPERIORITY||LS Mean difference|7.27||||0.035|TWO_SIDED|95.0|0.6|13.95|||ANCOVA|||||13.95|0.60|0.035
73835093|NCT03928704|147218842|SUPERIORITY||LS Mean difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.52|-0.14|||ANCOVA|||||-0.14|-0.52|<0.001
73835094|NCT03928704|147218842|SUPERIORITY||LS Mean difference|-0.5||||0.086|TWO_SIDED|95.0|-1.07|0.07|||ANCOVA|||||0.07|-1.07|0.086
73835095|NCT03928704|147218843|SUPERIORITY||LS Mean difference|-1.06|||=|0.013|TWO_SIDED|95.0|-1.88|-0.23|||ANCOVA|||||-0.23|-1.88|=0.013
73835096|NCT03928704|147218844|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.84|6.62|||Regression, Logistic|||||6.62|1.84|<0.001
73835097|NCT03083379|147218856|EQUIVALENCE|Equivalency is defined as no statistically significant difference in dorsal region redistribution of ventilation following breath cycle 1, 2, and 3 lung expansion therapy sequences.||||||0.9|||||||Mann-Whitney U test|||||||.90
73835098|NCT03403517|147218895|SUPERIORITY||Risk Ratio (RR)|0.859||||0.213|TWO_SIDED|95.0|0.682|1.082|||Fisher Exact|||||1.082|0.682|0.213
73835099|NCT03403517|147218899|SUPERIORITY||Risk Ratio (RR)|0.977|||>|0.999|TWO_SIDED|95.0|0.557|1.715|||Fisher Exact|||||1.715|0.557|>0.999
73835100|NCT03403517|147218900|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.160
73835101|NCT00327171|147218914|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.123||||0.5043|TWO_SIDED|95.0|0.8|1.58|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor|||1.58|0.80|0.5043
73835102|NCT00327171|147218917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.093||||0.5592|TWO_SIDED|95.0|0.81|1.48|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4mg/kg vs. 2mg/kg)|||1.48|0.81|0.5592
73835103|NCT00327171|147218918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.124||||0.5457|TWO_SIDED|95.0|0.77|1.64|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4 mg/kg vs. 2mg/kg)|||1.64|0.77|0.5457
73835104|NCT01779362|147218942|SUPERIORITY||||||>|0.05||||||All analyses were conducted with values on a log scale and re-exponentiated for presentation.|Regression, Linear|Measures of ß-cell response were modeled simultaneously with insulin sensitivity (M/I) using 2-df seemingly unrelated regression models.||Seemingly unrelated regression was used to compare treatment arms on the combination of insulin sensitivity (M/I as calculated from the hyperglycemic clamp) and insulin secretion (steady-state C-peptide and ACPRmax as co-primary; ACPRg as major secondary,). See statistical analysis plan for further details and R code.||||>0.05
73835105|NCT01779362|147218943|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
73835106|NCT01779362|147218944|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
73835107|NCT01779362|147218945|SUPERIORITY||||||<|0.001||||||For all 3 secondary outcomes at M12, p\<0.001, with the Liraglutide+Metformin group different from the 3 others (all p\<0.001).|ANOVA|||Analyses were completed on a log scale and re-exponentiated for display.||||<0.001
73835108|NCT00422461|147218948|SUPERIORITY||Least square (LS) mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.6||0.0822|TWO_SIDED|95.0|-5.97|0.36|||Nonlinear dose response regression model|||||0.36|-5.97|0.0822
73835109|NCT00422461|147218948|SUPERIORITY||LS mean difference|-4.66|STANDARD_ERROR_OF_MEAN|1.92||0.017|TWO_SIDED|95.0|-8.47|-0.85|||Nonlinear dose response regression model|||||-0.85|-8.47|0.0170
73835110|NCT00422461|147218948|SUPERIORITY||LS mean difference|-6.97|STANDARD_ERROR_OF_MEAN|2.26||0.0026|TWO_SIDED|95.0|-11.45|-2.48|||Nonlinear dose response regression model|||||-2.48|-11.45|0.0026
73835111|NCT00422461|147218949|SUPERIORITY||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|1.2||0.0264|TWO_SIDED|95.0|-5.09|-0.32|||Nonlinear dose response regression model|||||-0.32|-5.09|0.0264
73835112|NCT00422461|147218949|SUPERIORITY||LS mean difference|-4.56|STANDARD_ERROR_OF_MEAN|1.41||0.0016|TWO_SIDED|95.0|-7.35|-1.77|||Nonlinear dose response regression model|||||-1.77|-7.35|0.0016
73896714|NCT00955201|147326632|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
73835113|NCT00422461|147218949|SUPERIORITY||LS mean difference|-6.96|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-10.03|-3.89|||Nonlinear dose response regression model|||||-3.89|-10.03|<0.0001
73835114|NCT00422461|147218950|SUPERIORITY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.98||0.9479|TWO_SIDED|95.0|-3.79|4.05|||ANCOVA|||For SBP||4.05|-3.79|0.9479
73835115|NCT00422461|147218950|SUPERIORITY||LS mean difference|-4.75|STANDARD_ERROR_OF_MEAN|2.03||0.0215|TWO_SIDED|95.0|-8.78|-0.72|||ANCOVA|||For SBP||-0.72|-8.78|0.0215
73835116|NCT00422461|147218950|SUPERIORITY||LS mean difference|-3.43|STANDARD_ERROR_OF_MEAN|2.0||0.0886|TWO_SIDED|95.0|-7.39|0.53|||ANCOVA|||For SBP||0.53|-7.39|0.0886
73835117|NCT00422461|147218950|SUPERIORITY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.44||0.3173|TWO_SIDED|95.0|-4.3|1.41|||ANCOVA|||For DBP||1.41|-4.30|0.3173
73835118|NCT00422461|147218950|SUPERIORITY||LS mean difference|-3.81|STANDARD_ERROR_OF_MEAN|1.42||0.0087|TWO_SIDED|95.0|-6.64|-0.99|||ANCOVA|||For DBP||-0.99|-6.64|0.0087
73835119|NCT00422461|147218950|SUPERIORITY||LS mean difference|-3.95|STANDARD_ERROR_OF_MEAN|1.41||0.0062|TWO_SIDED|95.0|-6.76|-1.15|||ANCOVA|||For DBP||-1.15|-6.76|0.0062
73835120|NCT00422461|147218952|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|2.48||0.8091|TWO_SIDED|95.0|-5.51|4.31|||ANCOVA|||For cuff SBP||4.31|-5.51|0.8091
73835121|NCT00422461|147218952|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|2.44||0.8809|TWO_SIDED|95.0|-5.21|4.48|||ANCOVA|||For cuff SBP||4.48|-5.21|0.8809
73835122|NCT00422461|147218952|SUPERIORITY||LS mean difference|-5.16|STANDARD_ERROR_OF_MEAN|2.46||0.0382|TWO_SIDED|95.0|-10.04|-0.29|||ANCOVA|||For cuff SBP||-0.29|-10.04|0.0382
73835123|NCT00422461|147218952|SUPERIORITY||LS mean difference|-3.03|STANDARD_ERROR_OF_MEAN|1.67||0.0731|TWO_SIDED|95.0|-6.35|0.29|||ANCOVA|||For cuff DBP||0.29|-6.35|0.0731
73835124|NCT00422461|147218952|SUPERIORITY||LS mean difference|-4.49|STANDARD_ERROR_OF_MEAN|1.65||0.0077|TWO_SIDED|95.0|-7.77|-1.22|||ANCOVA|||For cuff DBP||-1.22|-7.77|0.0077
73835125|NCT00422461|147218952|SUPERIORITY||LS mean difference|-4.29|STANDARD_ERROR_OF_MEAN|1.66||0.0111|TWO_SIDED|95.0|-7.58|-1.0|||ANCOVA|||For cuff DBP||-1.00|-7.58|0.0111
73835126|NCT00422461|147218954|SUPERIORITY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|1.7||0.2567|TWO_SIDED|95.0|-5.32|1.44|||ANCOVA|||||1.44|-5.32|0.2567
73835127|NCT00422461|147218954|SUPERIORITY||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|1.69||0.086|TWO_SIDED|95.0|-6.29|0.42|||ANCOVA|||||0.42|-6.29|0.0860
73835128|NCT00422461|147218954|SUPERIORITY||LS mean difference|-4.46|STANDARD_ERROR_OF_MEAN|1.71||0.0103|TWO_SIDED|95.0|-7.85|-1.08|||ANCOVA|||||-1.08|-7.85|0.0103
73835129|NCT01795937|147218965|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|198.55|STANDARD_DEVIATION|14.2|||TWO_SIDED|90.0|182.43|216.09|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir||216.09|182.43|
73835130|NCT01795937|147218966|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|180.63|STANDARD_DEVIATION|14.5|||TWO_SIDED|90.0|165.68|196.93|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir.||196.93|165.68|
73835131|NCT01795937|147218967|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|946.45|STANDARD_DEVIATION|27.3|||TWO_SIDED|90.0|797.61|1123.07|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||1123.07|797.61|
73835132|NCT01795937|147218968|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3372.72|STANDARD_DEVIATION|20.5|||TWO_SIDED|90.0|2961.95|3840.47|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||3840.47|2961.95|
73835133|NCT01795937|147218971|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1358.91|STANDARD_DEVIATION|16.4|||TWO_SIDED|90.0|1224.32|1508.29|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||1508.29|1224.32|
73835134|NCT01795937|147218972|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1466.35|STANDARD_DEVIATION|23.3|||TWO_SIDED|90.0|1277.62|1682.95|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||1682.95|1277.62|
73835135|NCT01795937|147218973|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3288.7|STANDARD_DEVIATION|28.5|||TWO_SIDED|90.0|2782.04|3887.63|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||3887.63|2782.04|
73835136|NCT01795937|147218974|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1678.23|STANDARD_DEVIATION|22.6|||TWO_SIDED|90.0|1468.52|1917.89|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||1917.89|1468.52|
73835137|NCT03593629|147218985|NON_INFERIORITY|Non-inferiority margin was defined as -10%|Risk Difference (RD)|2.37|||||ONE_SIDED|95.0|-5.05||||||||||-5.05|
73835138|NCT03593629|147218986|NON_INFERIORITY|non-inferiority margin is defined as -10%|Risk Difference (RD)|-2.6|||||ONE_SIDED|95.0|-8.88||||||||||-8.88|
73835139|NCT03593629|147218987|NON_INFERIORITY|non-inferiority margin is defined as -10%|Risk Difference (RD)|-1.15|||||ONE_SIDED|95.0|-6.89||||||||||-6.89|
73835140|NCT00983957|147219012|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.105|||||TWO_SIDED|90.0|1.023|1.195|||||Point estimates and 90% Confidence Interval (CIs) for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.195|1.023|
73835141|NCT00983957|147219013|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.071|||||TWO_SIDED|90.0|0.988|1.16|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.160|0.988|
73835142|NCT00983957|147219014|SUPERIORITY_OR_OTHER||Adjusted geometric mean|1.009|||||TWO_SIDED|90.0|0.951|1.07|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.070|0.951|
73835143|NCT00983957|147219015|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.121|||||TWO_SIDED|90.0|1.018|1.234|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.234|1.018|
73835144|NCT00983957|147219018|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.059|||||TWO_SIDED|90.0|0.988|1.135|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.135|0.988|
73835145|NCT00983957|147219023|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.115|||||TWO_SIDED|90.0|1.063|1.171|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.171|1.063|
73835146|NCT03676725|147219115|SUPERIORITY||Odds Ratio (OR)|5.17||||0.017|ONE_SIDED||||||Fisher Exact|||Women with PMS vs. without PMS.||||0.017
73835147|NCT03676725|147219115|SUPERIORITY||Odds Ratio (OR)|16.0||||0.001|TWO_SIDED||||||Fisher Exact|||Women with PMS and with ADHD vs. other women||||0.001
73835148|NCT03676725|147219115|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8|TWO_SIDED||||||Fisher Exact|||ADHD vs. no ADHD||||0.8
73835149|NCT02421510|147219149|SUPERIORITY||Least squares mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.058|<|0.001|TWO_SIDED|95.0|-0.48|-0.25||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.||-0.25|-0.48|< 0.001
73835150|NCT02421510|147219149|SUPERIORITY||Least squares mean difference|-0.35|||<|0.001|TWO_SIDED|95.0|-0.47|-0.24||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from Mixed effect Model Repeat Measurement (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C- by-time interaction as a covariate.||-0.24|-0.47|< 0.001
73835151|NCT02421510|147219150|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|16.3|||<|0.001|TWO_SIDED|95.0|9.17|23.43||Threshold for significance \<= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 200 mg versus Placebo|P-values were obtained from a Cochran-Mantel-Haenszel (CMH) test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (\<=8.5%, \>8.5%). The 95% Confidence Limits (CL) were calculated using asymptotic Wald method. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.||23.43|9.17|< 0.001
73835152|NCT02421510|147219150|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|17.2|||<|0.001|TWO_SIDED|95.0|10.06|24.35||Threshold for significance \<= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 400 mg versus Placebo|P-values were obtained from a CMH test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%). The 95% CL were calculated using asymptotic Wald method.||24.35|10.06|< 0.001
73835153|NCT02421510|147219151|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-1.98|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-2.53|-1.44||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.||-1.44|-2.53|< 0.001
73835154|NCT02421510|147219151|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-2.58|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-3.12|-2.04|||MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.||-2.04|-3.12|< 0.001
73896715|NCT00955201|147326632|SUPERIORITY|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.89
73896716|NCT00955201|147326632|SUPERIORITY|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.90
73896717|NCT00955201|147326632|SUPERIORITY|||||||0.98|||||||ANOVA|||Comparison across groups at baseline||||0.98
73896718|NCT00955201|147326632|SUPERIORITY|||||||0.94|||||||ANOVA|||Comparison across groups at 12-wks||||0.94
73835155|NCT02421510|147219152|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.847|<|0.001|TWO_SIDED|95.0|-4.86|-1.53||Threshold for significance \<=0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-1.53|-4.86|< 0.001
73835156|NCT02421510|147219152|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.59|STANDARD_ERROR_OF_MEAN|0.845|<|0.001|TWO_SIDED|95.0|-5.25|-1.93||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-1.93|-5.25|< 0.001
73835157|NCT02421510|147219153|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-21.6|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-32.2|-11.0||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.||-11|-32.2|< 0.001
73835158|NCT02421510|147219153|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-25.7|STANDARD_ERROR_OF_MEAN|5.37|<|0.001|TWO_SIDED|95.0|-36.2|-15.1||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.||-15.1|-36.2|< 0.001
73835159|NCT02421510|147219154|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|1.3|2.7||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.||2.7|1.3|< 0.001
73835160|NCT02421510|147219154|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|1.0|2.4||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.||2.4|1|< 0.001
73835161|NCT02421510|147219155|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.025|TWO_SIDED|95.0|-0.6|0.0||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.||0|-0.6|0.025
73835162|NCT02421510|147219155|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.003|TWO_SIDED|95.0|-0.7|-0.2||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<=8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.||-0.2|-0.7|0.003
73835163|NCT00888849|147219245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|7.69||0.7774|TWO_SIDED|95.0|-19.4|10.9||Adjusted for multiplicity via the Bonferroni-Holm method|ANOVA|||||10.9|-19.4|0.7774
73835164|NCT00888849|147219246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|0.8||0.0008|TWO_SIDED|95.0|1.4|4.5||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA|||||4.5|1.4|0.0008
73835165|NCT00888849|147219247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.7774|TWO_SIDED|95.0|-0.2|0.6||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA|||||0.6|-0.2|0.7774
73896719|NCT00955201|147326632|SUPERIORITY|||||||0.91|||||||ANOVA|||Comparison across groups at 24-wks.||||0.91
73835166|NCT02508207|147219248|OTHER|||||||0.7151||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.7151
73835167|NCT02508207|147219249|OTHER|||||||0.0004||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.0004
73835168|NCT02508207|147219250|OTHER|||||||0.3345|||||||t-test, 2 sided|p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.||||||0.3345
73835169|NCT02508207|147219251|OTHER|||||||0.0002||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.0002
73835170|NCT02122952|147219256|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial Test|||Data for the current study were compared to historical control data (Pediatric Neuromuscular Clinical Research \[PNCR\], Finkel et al 2014 - PubMed 25080519) where 0 participants were able to sit independently.||||<0.001
73835171|NCT00896233|147219257|SUPERIORITY_OR_OTHER||ICC|0.9|||||TWO_SIDED|90.0|0.81|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.81|
73835172|NCT00896233|147219257|SUPERIORITY_OR_OTHER||ICC|0.85|||||TWO_SIDED|90.0|0.71|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.98|0.71|
73835173|NCT00896233|147219257|SUPERIORITY_OR_OTHER||ICC|0.88|||||TWO_SIDED|90.0|0.78|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||0.98|0.78|
73835174|NCT00896233|147219257|SUPERIORITY_OR_OTHER||ICC|0.86|||||TWO_SIDED|90.0|0.75|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||0.98|0.75|
73835175|NCT00896233|147219258|SUPERIORITY_OR_OTHER||ICC|0.9|||||TWO_SIDED|90.0|0.8|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.80|
73835176|NCT00896233|147219258|SUPERIORITY_OR_OTHER||ICC|0.88|||||TWO_SIDED|90.0|0.78|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.78|
73835177|NCT00896233|147219258|SUPERIORITY_OR_OTHER||ICC|0.93|||||TWO_SIDED|90.0|0.87|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||1.00|0.87|
73835178|NCT00896233|147219258|SUPERIORITY_OR_OTHER||ICC|0.94|||||TWO_SIDED|90.0|0.88|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||1.00|0.88|
73835179|NCT00514917|147219290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0501|TWO_SIDED|95.0|1.0|1.65||A priori threshold for statistical significance = 0.05|Log Rank|P-value was not adjusted for multiplicity of tests.|The hazard ratio Leuprolide+Bicalutamide vs. Docetaxel+Leuprolide+Bicalutamide was estimated using an un-stratified Cox proportional hazards model. A hazard ratio \>1 indicates a lower risk of Docetaxel+Leuprolide, compared to Leuprolide.|"Null hypothesis: No difference between new treatment combination (Docetaxel+Leuprolide+Bicalutamide) and conventional treatment (Leuprolide+Bicalutamide).~The study was sized to have 90% power to detect a difference between treatment arms at a 2-sided 0.05 significance level with 186 events and anticipating 10% non-evaluable participants."||1.65|1.00|0.0501
73835180|NCT02697422|147219301|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
73835181|NCT02697422|147219302|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
73835182|NCT02697422|147219303|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
73835183|NCT02697422|147219304|SUPERIORITY|||||||0.9|TWO_SIDED|95.0||||Smoker/tobacco use results were calculated using logistic regression.|Regression, Logistic|||Smoker/tobacco use results were calculated using logistic regression. A P value of .90 was found comparing smoking/tobacco use in intervention vs control participants. A difference was not reported between intervention and control because smoking/ tobacco use was a binary variable.||||0.90
73835184|NCT02697422|147219305|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
73835185|NCT02697422|147219306|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
73835186|NCT02697422|147219307|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
73835187|NCT02697422|147219308|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
73835188|NCT02697422|147219309|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
73835189|NCT02697422|147219310|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
73835190|NCT01659541|147219312|OTHER|Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control (Pre-Implant); comparisons was made at various points in the study (Week #28, #40 and #52).||||<0.05
73835191|NCT01659541|147219313|OTHER|Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control (Pre-Implant); comparisons were made at various points in the study (Week #28, #40 and #52).||||<0.05
73835192|NCT01659541|147219314|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant)) were compared with data obtained after implantation (Week ##28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
73835193|NCT01659541|147219315|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
73835194|NCT01659541|147219316|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28 ,#40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. Paired t test. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
73835195|NCT01659541|147219317|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
73835196|NCT00309244|147219332|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52-week data, resulting in \> 90% power for a non-inferiority test of the difference in 12-month change of HbA1c scores between treatment groups with non-inferiority margin of 0.4%, standard deviation of 1.2 and 1-sided alpha of 0.025. Allowing for a 25% drop-out rate, 677 subjects were randomized.|Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|95.0|-0.05|0.29|||ANCOVA|||||0.29|-0.05|
73835197|NCT00309244|147219333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.41||0.0002|TWO_SIDED|95.0|-2.4|-0.7|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate||-0.7|-2.4|0.0002
73835198|NCT00309244|147219334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7|STANDARD_ERROR_OF_MEAN|5.9||0.0029|TWO_SIDED|95.0|-29.3|-6.1|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline fasting plasma glucose as covariate||-6.1|-29.3|0.0029
73835199|NCT00309244|147219335|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.774||||0.2793|TWO_SIDED|95.0|0.486|1.231|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model||1.231|0.486|0.2793
73835200|NCT00309244|147219336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.423|||<|0.001|TWO_SIDED|95.0|0.307|0.581|||Regression, Logistic||Model: Treatment + Site|||0.581|0.307|<0.001
73835201|NCT00309244|147219337|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.409||||0.0066|TWO_SIDED|95.0|0.215|0.78|||Regression, Logistic||Model: Treatment + Site|||0.780|0.215|0.0066
73835202|NCT00309244|147219338|SUPERIORITY_OR_OTHER|||||||0.0027|||||||Generalized Estimation Equation|Based on Poisson distribution||||||0.0027
73835203|NCT00309244|147219339|SUPERIORITY_OR_OTHER|||||||0.0591|||||||Generalized Estimating Equation|Based on Poission distribution||||||0.0591
73835204|NCT03019588|147219345|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.29|TWO_SIDED|95.0|0.58|1.36|||Log Rank|One-sided p-value based on log-rank test stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||1.36|0.58|0.2900
73835205|NCT03019588|147219346|SUPERIORITY||Hazard Ratio (HR)|1.77||||0.9954|TWO_SIDED|95.0|1.14|2.74|||Log Rank|One-sided p-value based on log-rank test stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||2.74|1.14|0.9954
73835206|NCT03019588|147219347|SUPERIORITY||Difference in percentage|-6.0||||0.7884|TWO_SIDED|95.0|-21.6|9.3|||Z-test|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||9.3|-21.6|0.7884
73835207|NCT00106535|147219375|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73835208|NCT00106535|147219375|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73835209|NCT00106535|147219376|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73835210|NCT00106535|147219376|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73835211|NCT00106535|147219377|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73835212|NCT00106535|147219377|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
73835213|NCT00106535|147219386|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
73835214|NCT00106535|147219386|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
73835215|NCT00106535|147219387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.26|||<|0.0001|TWO_SIDED|95.0|-96.96|-43.56|||ANOVA|Adjusted for region and original treatment group.||||-43.56|-96.96|<0.0001
73835216|NCT00106535|147219387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-85.95|||<|0.0001|TWO_SIDED|95.0|-112.69|-59.22|||ANOVA|Adjusted for region and original treatment group.||||-59.22|-112.69|<0.0001
73835217|NCT00106535|147219389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-148.1|||<|0.0001|TWO_SIDED|95.0|-205.22|-90.98|||ANOVA|Adjusted for region.||||-90.98|-205.22|<0.0001
73835218|NCT00106535|147219389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-181.4|||<|0.0001|TWO_SIDED|95.0|-238.6|-124.21|||ANOVA|Adjusted for region.||||-124.21|-238.60|<0.0001
73835219|NCT00106535|147219414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5212.28|||<|0.0001|TWO_SIDED|95.0|3139.4|7285.16|||ANOVA|Adjusted for region.||||7285.16|3139.40|<0.0001
73835220|NCT00106535|147219414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7092.76|||<|0.0001|TWO_SIDED|95.0|5066.16|9119.36||Adjusted for region.|ANOVA|||||9119.36|5066.16|<0.0001
73835221|NCT00106535|147219430|SUPERIORITY_OR_OTHER|||||||0.0023||95.0|||||Van Elteren's test|Stratified by region.||||||0.0023
73835222|NCT00106535|147219430|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|||||||<0.0001
73835223|NCT00106535|147219431|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||0.0001
73835224|NCT00106535|147219431|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
73835225|NCT00727064|147219483|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||<0.001
73835226|NCT00727064|147219484|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||<0.001
73835227|NCT00727064|147219485|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.004
73835228|NCT00727064|147219486|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.018
73835229|NCT00727064|147219487|SUPERIORITY_OR_OTHER|||||||0.081|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.081
73835230|NCT00727064|147219488|SUPERIORITY_OR_OTHER|||||||0.427|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.427
73835231|NCT00126737|147219489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.395||||0.0129|TWO_SIDED|95.0|-11.41|-1.38|||ANCOVA|Co-variates entered into the model were BMI and WOMAC function subscale.||||-1.38|-11.41|0.0129
73835232|NCT00126737|147219489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.174||||0.0535|TWO_SIDED|95.0|-10.43|0.079|||ANCOVA|Covariates entered into the model were BMI and WOMAC function||||0.079|-10.43|0.0535
73835233|NCT00126737|147219490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.545||||0.0307|TWO_SIDED|95.0|0.432|8.659|||ANCOVA|||||8.659|0.432|0.0307
73835234|NCT00126737|147219492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.94||||0.0158|TWO_SIDED|95.0|7.655|72.215|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||72.215|7.655|0.0158
73835235|NCT00126737|147219492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.25||||0.0002|TWO_SIDED|95.0|29.97|94.54|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||94.54|29.97|0.0002
73835236|NCT00126737|147219492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.95||||0.0056|TWO_SIDED|95.0|12.54|75.36|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||75.36|12.54|0.0056
73835237|NCT00126737|147219493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.129||||0.0018|TWO_SIDED|95.0|10.767|45.492|||ANCOVA|Kellgren Lawrence Scale was entered into the model||||45.492|10.767|0.0018
73835238|NCT00126737|147219493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.71||||0.0024|TWO_SIDED|95.0|9.675|43.746|||ANCOVA|Kellgren Lawrence scale was entered into the model||||43.746|9.675|0.0024
73835239|NCT00126737|147219493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.747||||0.0368|TWO_SIDED|95.0|1.169|36.325|||ANCOVA|Kellgren Lawrence Scale was entered into the model||||36.325|1.169|0.0368
73835240|NCT01501513|147219514|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
73835241|NCT00567580|147219569|SUPERIORITY||||||<|0.001||||||One-sided significance level = 0.001|Z test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||<0.001
73835242|NCT00567580|147219569|SUPERIORITY|||||||0.003|||||||Z-test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||0.003
73835243|NCT00567580|147219569|SUPERIORITY||||||<|0.001|||||||Z-test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||<0.001
73835244|NCT00567580|147219570|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|97.5|0.45|0.72||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.72|0.45|<0.001
73835245|NCT00567580|147219570|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|97.5|0.51|0.89||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||0.89|0.51|<0.001
73835246|NCT00567580|147219570|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|97.5|0.3|0.51||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.51|0.30|<0.001
73835247|NCT00567580|147219571|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.137|TWO_SIDED|97.5|0.39|1.39||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.39|0.39|0.137
73835248|NCT00567580|147219571|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.007|TWO_SIDED|97.5|0.16|0.95||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||0.95|0.16|0.007
73835249|NCT00567580|147219571|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|97.5|0.12|0.68||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.68|0.12|<0.001
73835250|NCT00567580|147219572|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|97.5|0.14|1.01||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.01|0.14|0.010
73835251|NCT00567580|147219572|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.177|TWO_SIDED|97.5|0.14|2.3||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||2.30|0.14|0.177
73835252|NCT00567580|147219572|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|97.5|0.06|0.71||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.71|0.06|<0.001
73835253|NCT00567580|147219573|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.105|TWO_SIDED|97.5|0.49|1.22||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.22|0.49|0.105
73835254|NCT00567580|147219573|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.022|TWO_SIDED|97.5|0.36|1.06||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.06|0.36|0.022
73835255|NCT00567580|147219573|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|97.5|0.29|0.81||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.81|0.29|<0.001
73835256|NCT00567580|147219574|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.137|TWO_SIDED|97.5|0.35|1.43||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.43|0.35|0.137
73835257|NCT00567580|147219574|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.141|TWO_SIDED|97.5|0.3|1.54||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.54|0.30|0.141
73835258|NCT00567580|147219574|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.014|TWO_SIDED|97.5|0.21|1.03||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.03|0.21|0.014
73835259|NCT00567580|147219575|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.235|TWO_SIDED|97.5|0.54|1.38||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.38|0.54|0.235
73835260|NCT00567580|147219575|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.481|TWO_SIDED|97.5|0.61|1.6||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.60|0.61|0.481
73835261|NCT00567580|147219575|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.213|TWO_SIDED|97.5|0.53|1.35||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.35|0.53|0.213
73835262|NCT00567580|147219576|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.001|TWO_SIDED|97.5|1.81|3.37||One-sided significance level = 0.025|Regression, Logistic|Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.|Reference level = PBRT Alone|Acute grade 2+ acute adverse events||3.37|1.81|<0.001
73835263|NCT00567580|147219576|SUPERIORITY||Odds Ratio (OR)|1.35||||0.007|TWO_SIDED|97.5|1.03|1.77||One-sided significance level = 0.025|Regression, Logistic|Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.|Reference level = PBRT + STAD|Acute grade 2+ acute adverse events||1.77|1.03|0.007
73835264|NCT00567580|147219576|SUPERIORITY||Odds Ratio (OR)|2.04||||0.002|TWO_SIDED|97.5|1.16|3.6||One-sided significance level = 0.025|Regression, Logistic|Univariate model was used due to the low number of events.|Reference level = PBRT Alone|Acute grade 3+ acute adverse events||3.60|1.16|0.002
73835265|NCT00567580|147219576|SUPERIORITY||Odds Ratio (OR)|1.47||||0.025|TWO_SIDED|95.0|0.975|2.27||One-sided significance level = 0.025|Regression, Logistic|Univariate model was used due to the low number of events.|Reference level = PBRT + STAD|Acute grade 3+ adverse events||2.27|0.975|0.025
73835266|NCT00567580|147219577|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.268|TWO_SIDED|97.5|0.88|1.26||One-sided significance level = 0.025|Log Rank||Reference level = PBRT Alone|Late grade 2+ adverse events||1.26|0.88|0.268
73835267|NCT00567580|147219577|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.101|TWO_SIDED|97.5|0.93|1.32||One-sided significance level = 0.025|Log Rank||Reference level = PBRT + STAD|Late grade 2+ adverse events||1.32|0.93|0.101
73835268|NCT00567580|147219577|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.119|TWO_SIDED|97.5|0.83|1.8||One-sided significance level = 0.025|Log Rank||Reference level = PBRT Alone|Late grade 3+ adverse events||1.80|0.83|0.119
73835269|NCT00567580|147219577|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.17|TWO_SIDED|97.5|0.82|1.65||One-sided significance level = 0.025|Log Rank||Reference level = PBRT + STAD|Late grade 3+ adverse events||1.65|0.82|0.170
73835270|NCT03197935|147219618|SUPERIORITY||Absolute difference in pCR rate|16.5||||0.0044|TWO_SIDED|95.0|5.91|27.1||(one-sided)|Cochran-Mantel-Haenszel|||Stratified analysis. Strata are: tumor PD-L1 status (IC0 vs. IC1/2/3) and clinical stage at presentation (Stage II vs. III).||27.10|5.91|0.0044
73835271|NCT03197935|147219619|SUPERIORITY||Difference in pCR|19.5||||0.0206|TWO_SIDED|95.0|4.17|34.83||(one-sided)|Cochran-Mantel-Haenszel|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||34.83|4.17|0.0206
73835272|NCT03197935|147219620|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.47|1.21|||Stratified log-rank test|||"Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III)."||1.21|0.47|
73835273|NCT03197935|147219621|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.|Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.26|1.18|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.18|0.26|
73835274|NCT03197935|147219622|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.44|1.3|||Stratified log-rank test|||Stratified analysis. Strata are: Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).||1.30|0.44|
73835275|NCT03197935|147219623|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.23|1.43|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.43|0.23|
73835276|NCT03197935|147219624|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of OS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.3|1.04|||Stratified log-rank test|||"Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III)."||1.04|0.30|
73835277|NCT03197935|147219625|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.26|1.91|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.91|0.26|
73835278|NCT02357485|147219640|SUPERIORITY_OR_OTHER||||||<|0.004|TWO_SIDED|||||Baseline vs 1 year Post-treatment|t-test, 2 sided|||||||<0.004
73835279|NCT02357485|147219641|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Baseline vs 1 year Post-treatment|t-test, 2 sided|||||||<0.001
73835280|NCT02357485|147219642|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||0.053
73835281|NCT02357485|147219643|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
73835282|NCT00666978|147219773|SUPERIORITY|The x2 test was used to determine whether there was a difference between treatment groups (bupropion SR vs placebo) in verified 7-day point prevalence abstinence at week 26, imputing the missing participants as smokers.|Odds Ratio (OR)|1.39||||0.23|TWO_SIDED|95.0|0.82|2.35||All tests of statistical significance were two-sided, and all P values less than .05 were considered statistically significant.|t-test, 2 sided||Raw proportions were used to estimate the verified cessation rate in each group and corresponding odds ratio along with its 95% confidence interval .|Based on our previous studies, sample size was determined a priori assuming a two-sided x2 test with a type I error rate of .05, a power of 80%, and a cotinine-verified abstinence rate of 15% in the placebo group and 25% in the bupropion SR group at week 26, with the assumption that those lost to follow-up would be imputed as smokers.||2.35|0.82|.23
73835283|NCT00666978|147219774|OTHER||Odds Ratio (OR)|0.97||||0.0022|TWO_SIDED|95.0|0.95|0.99||This reflects Week 7.|Regression, Logistic||This reflects Week 7.|||0.99|0.95|0.0022
73835284|NCT00666978|147219775|OTHER||Odds Ratio (OR)|2.82|||<|0.05|TWO_SIDED|||||Analysis relied on examining quit rates using linear regression, where the hydroxybupropion was a significant predictor of smoking cessation. CYP2B6 genotype was not a direct significant predictor of cessation in either the placebo or bupropion arm.|Regression, Linear||Bupropion adherent individuals with higher hydroxybupropion levels were more likely to be abstinent at Weeks 3, 7 and 26 compared to individuals with lower hydroxybupropion levels.|||||<0.05
73835285|NCT01160744|147219786|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.1318|TWO_SIDED|90.0|0.55|1.03|||Log Rank|||||1.03|0.55|0.1318
73835286|NCT01160744|147219786|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.5215|TWO_SIDED|90.0|0.64|1.22|||Log Rank|||||1.22|0.64|0.5215
73835287|NCT01160744|147219787|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.58||||0.1797|TWO_SIDED|90.0|0.9|2.78|||Chi-squared|||||2.78|0.90|0.1797
73835288|NCT01160744|147219787|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.66||||0.007|TWO_SIDED|90.0|1.45|4.86|||Chi-squared|||||4.86|1.45|0.0070
73835289|NCT01160744|147219788|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.8916|TWO_SIDED|90.0|0.74|1.42|||Log Rank|||||1.42|0.74|0.8916
73835290|NCT01160744|147219788|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.6847|TWO_SIDED|90.0|0.68|1.27|||Log Rank|||||1.27|0.68|0.6847
73835291|NCT01160744|147219791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.48||||0.0316|TWO_SIDED|90.0|1.22|5.02|||Chi-squared|||||5.02|1.22|0.0316
73835292|NCT01160744|147219791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.3962|TWO_SIDED|90.0|0.74|2.52|||Chi-squared|||||2.52|0.74|0.3962
73835293|NCT01160744|147219792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1571|TWO_SIDED||||||t-test, 2 sided|||||||0.1571
73835294|NCT01160744|147219792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1597|TWO_SIDED||||||t-test, 2 sided|||||||0.1597
73835295|NCT02993302|147219797|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
73835296|NCT02993302|147219798|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
73835297|NCT02993302|147219799|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
73835298|NCT01755637|147219803|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean Ratio of treatments|114.37|||||TWO_SIDED|90.0|100.49|130.16|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||130.16|100.49|
73835299|NCT01755637|147219804|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|107.41|||||TWO_SIDED|90.0|69.03|167.13|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||167.13|69.03|
73835300|NCT01755637|147219805|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|111.28|||||TWO_SIDED|90.0|94.76|130.68|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||130.68|94.76|
73835301|NCT01755637|147219806|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0167||||0.0011||95.0|||||Wilcoxon signed rank test|The values were not adjusted for this non-parametric analysis.|The median difference was calculated as = (Experimental-Reference)|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.0011
73835302|NCT01755637|147219807|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|112.05|||||TWO_SIDED|90.0|103.65|121.12|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||121.12|103.65|
73835303|NCT01755637|147219808|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|113.1|||||TWO_SIDED|90.0|103.4|123.71|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||123.71|103.40|
73896720|NCT00955201|147326633|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
73896721|NCT00955201|147326633|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.99
73835304|NCT01755637|147219809|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|114.33|||||TWO_SIDED|90.0|102.99|126.93|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||126.93|102.99|
73835305|NCT03338023|147219831|NON_INFERIORITY|Noninferiority of LY2963016 to Lantus® was demonstrated at the 0.4% noninferiority margin and over 80 percent power.|Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.32|0.08||||||||0.08|-0.32|
73835306|NCT03338023|147219832|NON_INFERIORITY|Noninferiority of Lantus® to LY2963016 was demonstrated at the 0.4% noninferiority margin.|Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.32|0.08||||||||0.08|-0.32|
73835307|NCT03338023|147219833|SUPERIORITY||Mean Difference (Net)|-6.8||||0.191|TWO_SIDED|95.0|-17.0|3.4|||Mixed Models Analysis|||Before Morning Meal Glucose||3.4|-17.0|0.191
73835308|NCT03338023|147219833|SUPERIORITY||Mean Difference (Net)|-7.8||||0.25|TWO_SIDED|95.0|-21.2|5.5|||Mixed Models Analysis|||2 Hours After Morning Meal Glucose||5.5|-21.2|0.250
73835309|NCT03338023|147219833|SUPERIORITY||Mean Difference (Net)|-13.1||||0.028|TWO_SIDED|95.0|-24.7|-1.5|||Mixed Models Analysis|||Before Mid-Day Meal Glucose||-1.5|-24.7|0.028
73835310|NCT03338023|147219833|SUPERIORITY||Mean Difference (Net)|-3.6||||0.599|TWO_SIDED|95.0|-16.8|9.7|||Mixed Models Analysis|||2 Hours After Mid-Day Meal Glucose||9.7|-16.8|0.599
73835311|NCT03338023|147219833|SUPERIORITY||Mean Difference (Net)|-11.0||||0.109|TWO_SIDED|95.0|-24.4|2.5|||Mixed Models Analysis|||Before Evening Meal Glucose||2.5|-24.4|0.109
73835312|NCT03338023|147219833|SUPERIORITY||Mean Difference (Net)|-5.4||||0.452|TWO_SIDED|95.0|-19.4|8.6|||Mixed Models Analysis|||Bedtime Glucose||8.6|-19.4|0.452
73835313|NCT03338023|147219833|SUPERIORITY||Mean Difference (Net)|-7.4||||0.18|TWO_SIDED|95.0|-18.3|3.5|||Mixed Models Analysis|||0300 Am Glucose||3.5|-18.3|0.180
73835314|NCT03338023|147219834|SUPERIORITY|||||||0.787|||||||Fisher Exact|||||||0.787
73835315|NCT03338023|147219835|SUPERIORITY|||||||0.201|||||||Fisher Exact|||||||0.201
73835316|NCT03338023|147219836|SUPERIORITY||Mean Difference (Net)|-0.3||||0.885|TWO_SIDED|95.0|-0.4|3.4|||Mixed Models Analysis|||||3.4|-0.4|0.885
73835317|NCT03338023|147219837|SUPERIORITY||Mean Difference (Net)|-3.5||||0.328|TWO_SIDED|95.0|-10.6|3.6|||Mixed Models Analysis|||Morning Pre-meal Standard Deviation||3.6|-10.6|0.328
73835318|NCT03338023|147219837|SUPERIORITY||Mean Difference (Net)|-1.7||||0.467|TWO_SIDED|95.0|-6.5|3.0|||Mixed Models Analysis|||Daily Mean Standard Deviation||3.0|-6.5|0.467
73835319|NCT03338023|147219838|SUPERIORITY||Mean Difference (Net)|-0.8||||0.09|TWO_SIDED|95.0|-1.7|0.1|||Mixed Models Analysis|||||0.1|-1.7|0.090
73835320|NCT03338023|147219839|SUPERIORITY||Mean Difference (Net)|-1.2||||0.089|TWO_SIDED|95.0|-2.6|0.2|||Mixed Models Analysis|||||0.2|-2.6|0.089
73835321|NCT03338023|147219840|SUPERIORITY||Mean Difference (Net)|-0.1||||0.77|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.770
73835322|NCT03338023|147219841|SUPERIORITY||Mean Difference (Net)|-0.3||||0.879|TWO_SIDED|95.0|-3.9|3.3|||ANCOVA|||ITSQ Inconvenience of Regimen Transformed Score||3.3|-3.9|0.879
73835323|NCT03338023|147219841|SUPERIORITY||Mean Difference (Net)|-0.7||||0.788|TWO_SIDED|95.0|-5.9|4.5|||ANCOVA|||ITSQ Lifestyle Flexibility Transformed Score||4.5|-5.9|0.788
73835324|NCT03338023|147219841|SUPERIORITY||Mean Difference (Net)|-0.6||||0.775|TWO_SIDED|95.0|-4.5|3.3|||ANCOVA|||ITSQ Hypoglycemic Control Transformed Score||3.3|-4.5|0.775
73835325|NCT03338023|147219841|SUPERIORITY||Mean Difference (Net)|1.0||||0.681|TWO_SIDED|95.0|-3.6|5.6|||ANCOVA|||ITSQ Glycemic Control Transformed Score||5.6|-3.6|0.681
73835326|NCT03338023|147219841|SUPERIORITY||Mean Difference (Net)|0.4||||0.819|TWO_SIDED|95.0|-3.1|3.9|||ANCOVA|||ITSQ Insulin Delivery Device Satisfaction Transformed Score||3.9|-3.1|0.819
73835327|NCT03338023|147219841|SUPERIORITY||Mean Difference (Net)|-0.8||||0.605|TWO_SIDED|95.0|-3.9|2.3|||ANCOVA|||ITSQ Total Transformed Score||2.3|-3.9|0.605
73835328|NCT05061706|147219870|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-6.03|-3.02|||Mixed Effects Model for Repeated Measure|||||-3.02|-6.03|<0.0001
73835329|NCT05061706|147219871|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.72|-0.33|||Mixed Effects Model for Repeated Measure|||||-0.33|-0.72|<0.0001
73835330|NCT01222351|147219872|EQUIVALENCE|The null hypothesis was that there is no difference in the rate of cognitive decline between participants with and without amyloid.|Slope|-0.034||||0.02|TWO_SIDED||||||latent growth curve model|Latent growth curve models tested cognitive decline rate by amyloid status.|B weights were the estimates for the association between Aβ and cognitive change.|||||0.02
73835331|NCT03055507|147219878|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.05|TWO_SIDED|96.0|-2.4|0.5|||t-test, 1 sided|||||0.5|-2.4|<0.05
73835332|NCT03296345|147219886|OTHER||Mean Difference (Final Values)|-15.0||||0.004|TWO_SIDED|95.0|-28.0|-2.3|||Wilcoxon (Mann-Whitney)|||||-2.3|-28|0.004
73835333|NCT03296345|147219887|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
73835334|NCT03296345|147219888|OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
73835335|NCT03296345|147219890|OTHER|A Wilcoxon sign-rank, given non parametric data, was used to compare the intervention and historical control groups for statistical significance, while a student's t-test was used to estimate effect size||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
73835336|NCT02068599|147219900|SUPERIORITY||LSM difference from placebo|4.26||||0.1213|TWO_SIDED|95.0|-1.13|9.66||5% level of significance|mixed model for repeated measures|||LSM = least square mean||9.66|-1.13|0.1213
73835337|NCT02068599|147219900|SUPERIORITY||LSM difference from placebo|1.74||||0.5231|TWO_SIDED|95.0|-3.62|7.11||5% level of significance|mixed model for repeated measures|||LSM = least square mean||7.11|-3.62|0.5231
73835338|NCT02068599|147219901|SUPERIORITY||LSM difference from placebo|17.86||||0.1795|TWO_SIDED|95.0|-8.26|43.98||5% level of significance|mixed model for repeated measures|||LSM = least square mean||43.98|-8.26|0.1795
73835339|NCT02068599|147219901|SUPERIORITY||LSM difference from placebo|9.0||||0.4956|TWO_SIDED|95.0|-16.95|34.96||5% level of significance|mixed model for repeated measures|||LSM = least square mean||34.96|-16.95|0.4956
73835340|NCT02068599|147219902|SUPERIORITY||LSM difference from placebo|3.61||||0.1963|TWO_SIDED|95.0|-1.87|9.08||5% level of significance|mixed model for repeated measures|||||9.08|-1.87|0.1963
73835341|NCT02068599|147219902|SUPERIORITY||LSM difference from placebo|2.06||||0.4584|TWO_SIDED|95.0|-3.39|7.5||5% level of significance|mixed model for repeated measures|||||7.50|-3.39|0.4584
73835342|NCT02068599|147219903|SUPERIORITY||LSM difference from placebo|23.51||||0.642|TWO_SIDED|95.0|-75.83|122.84||5% level of significance|mixed model for repeated measures|||||122.84|-75.83|0.6420
73835343|NCT02068599|147219903|SUPERIORITY||LSM difference from placebo|-50.4||||0.3141|TWO_SIDED|95.0|-148.72|47.92||5% level of significance|mixed model for repeated measures|||||47.92|-148.72|0.3141
73835344|NCT02068599|147219904|SUPERIORITY||LSM difference from placebo|3.16||||0.6184|TWO_SIDED|95.0|-9.31|15.63||5% level of significance|mixed model for repeated measures|||||15.63|-9.31|0.6184
73835345|NCT02068599|147219904|SUPERIORITY||LSM difference from placebo|-3.48||||0.5775|TWO_SIDED|95.0|-15.78|8.81||5% level of significance|mixed model for repeated measures|||||8.81|-15.78|0.5775
73835346|NCT02068599|147219905|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1011|TWO_SIDED|95.0|0.345|1.099||5% level of significance|mixed model for repeated measures|||\>=50% responder rate||1.099|0.345|0.1011
73835347|NCT02068599|147219905|SUPERIORITY||Odds Ratio (OR)|1.06||||0.84|TWO_SIDED|95.0|0.615|1.819||5% level of significance|mixed model for repeated measures|||\>=50% responder rate||1.819|0.615|0.8400
73835348|NCT02068599|147219905|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6607|TWO_SIDED|95.0|0.531|1.494||5% level of significance|mixed model for repeated measures|||\>=30% responder rate||1.494|0.531|0.6607
73835349|NCT02068599|147219905|SUPERIORITY||Odds Ratio (OR)|0.87||||0.5777|TWO_SIDED|95.0|0.52|1.441||5% level of significance|mixed model for repeated measures|||\>=30% responder rate||1.441|0.520|0.5777
73835350|NCT02068599|147219906|SUPERIORITY||LSM difference from placebo|3.94||||0.4316|TWO_SIDED|95.0|-5.9|13.79||5% level of significance|mixed model for repeated measures|||||13.79|-5.90|0.4316
73835351|NCT02068599|147219906|SUPERIORITY||LSM difference from placebo|2.51||||0.6126|TWO_SIDED|95.0|-7.24|12.26||5% level of significance|mixed model for repeated measures|||||12.26|-7.24|0.6126
73835352|NCT02068599|147219907|SUPERIORITY||LSM difference from placebo|0.01||||0.9208|TWO_SIDED|95.0|-0.232|0.257||5% level of significance|mixed model for repeated measures|||Week 2||0.257|-0.232|0.9208
73835353|NCT02068599|147219907|SUPERIORITY||LSM difference from placebo|0.04||||0.7344|TWO_SIDED|95.0|-0.2|0.284||5% level of significance|mixed model for repeated measures|||Week 2||0.284|-0.200|0.7344
73835354|NCT02068599|147219907|SUPERIORITY||LSM difference from placebo|0.21||||0.1199|TWO_SIDED|95.0|-0.056|0.486||5% level of significance|mixed model for repeated measures|||Week 4||0.486|-0.056|0.1199
73835355|NCT02068599|147219907|SUPERIORITY||LSM difference from placebo|0.06||||0.6357|TWO_SIDED|95.0|-0.204|0.334||5% level of significance|mixed model for repeated measures|||Week 4||0.334|-0.204|0.6357
73835356|NCT02068599|147219908|SUPERIORITY||LSM difference from placebo|2.77||||0.2906|TWO_SIDED|95.0|-2.377|7.916||5% level of significance|mixed model for repeated measures|||Week 2||7.916|-2.377|0.2906
73835357|NCT02068599|147219908|SUPERIORITY||LSM difference from placebo|1.41||||0.5892|TWO_SIDED|95.0|-3.707|6.518||5% level of significance|mixed model for repeated measures|||Week 2||6.518|-3.707|0.5892
73835358|NCT02068599|147219908|SUPERIORITY||LSM difference from placebo|0.82||||0.7699|TWO_SIDED|95.0|-4.678|6.315||5% level of significance|mixed model for repeated measures|||Week 4||6.315|-4.678|0.7699
73835359|NCT02068599|147219908|SUPERIORITY||LSM difference from placebo|1.74||||0.532|TWO_SIDED|95.0|-3.721|7.193||5% level of significance|mixed model for repeated measures|||Week 4||7.193|-3.721|0.5320
73835360|NCT02068599|147219909|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5358|TWO_SIDED|95.0|0.501|1.433||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment\*week as explanatory factors. The unstructured working correlation structure was applied.||1.433|0.501|0.5358
73835361|NCT02068599|147219909|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1532|TWO_SIDED|95.0|0.87|2.423||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment\*week as explanatory factors. The unstructured working correlation structure was applied.||2.423|0.870|0.1532
73835362|NCT02945046|147219972|OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.3||0.9093|TWO_SIDED|95.0|-2.72|2.42||Threshold for significance at 0.05 level.|ANCOVA|||||2.42|-2.72|0.9093
73835363|NCT02945046|147219972|OTHER||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.1345|TWO_SIDED|95.0|-4.49|0.61||Threshold for significance at 0.05 level.|ANCOVA|||||0.61|-4.49|0.1345
73835364|NCT01666314|147220020|SUPERIORITY_OR_OTHER|||||||0.1078|TWO_SIDED||||||Fisher Exact|||||||0.1078
73835365|NCT01666314|147220021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.145||||0.0355|TWO_SIDED|95.0|0.9895|18.7606|||Fisher Exact||Odds ratio \>1 favors orteronel.|||18.7606|0.9895|0.0355
73835366|NCT02114684|147220047|SUPERIORITY|||||||0.46|||||||Fisher Exact|||comparison of culture negative results at week 8||||0.46
73835367|NCT02114684|147220047|SUPERIORITY|||||||0.43|||||||Fisher Exact|||comparison of culture negative results at month 6||||0.43
73835368|NCT02114684|147220048|SUPERIORITY|||||||0.018|||||||Gehan-Breslow-Wilcoxon test|||||||0.018
73835369|NCT02114684|147220049|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
73835370|NCT02114684|147220050|SUPERIORITY|||||||0.01||||||There are significantly more adverse events in the active arm|Mantel Haenszel|||Comparison of the number of adverse events in the two arms, controlling for HIV status||||0.01
73835371|NCT02114684|147220050|SUPERIORITY|||||||0.45|||||||Mantel Haenszel|||Comparison of the 8-week culture conversion rates in the two arms, controlling for HIV status||||0.45
73835372|NCT02114684|147220051|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
73835373|NCT00990769|147220052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|5.0|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample size calculation concluded that 20 patients in each group would have 80% power to detect a mean difference of 4 ± 4 with alpha equal to 0.05, as would be determined by a two-sample T test.||||>0.05
73835374|NCT04625972|147220055|SUPERIORITY||Relative Risk Reduction|33.31||||0.212|TWO_SIDED|95.0|-25.92|64.68|||Poisson regression||Primary Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||64.68|-25.92|0.212
73835375|NCT04625972|147220055|SUPERIORITY||Relative Risk Reduction|43.28||||0.044|TWO_SIDED|95.0|1.4|67.37|||Poisson regression||Final Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||67.37|1.40|0.044
73835376|NCT04625972|147220057|SUPERIORITY||Relative Risk Reduction|100.0||||0.664|ONE_SIDED|97.5|-1836.98||||Poisson regression||||||-1836.98|0.664
73835377|NCT04625972|147220058|SUPERIORITY||Relative Risk Reduction|13.9||||0.163|TWO_SIDED|95.0|-6.23|30.21|||Poisson regression|||||30.21|-6.23|0.163
73835378|NCT04625972|147220060|SUPERIORITY||Relative Risk Reduction|25.75||||0.744|TWO_SIDED|95.0|-343.53|87.57|||Poisson regression|||||87.57|-343.53|0.744
73835379|NCT00694122|147220063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|277.9|STANDARD_ERROR_OF_MEAN|164.9|<|0.05|TWO_SIDED|95.0|-75.9|631.6|||t-test, 2 sided|No adjustments were made. T-test type: Paired samples t-test (df=14) was performed using 15 within subject differences.|The comparative measures was defined as (mean AUC of glargine (Lantus)) minus (mean AUC of NPH).|||631.6|-75.9|<0.05
73835380|NCT00694122|147220064|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73835381|NCT00694122|147220068|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
73835382|NCT00809146|147220075|NON_INFERIORITY_OR_EQUIVALENCE|Assay sensitivity established by extensive review of lorazepam efficacy data. Noninferiority margin of 10% established by both clinical and statistical reasoning.|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|0.04|0.16|||one-sided z statistic|||The null hypothesis of inferiority was tested with a one-sided z statistic. Sample size was estimated assuming independent proportions, 2 interim analyses, 70% control event rate; 90% power; a noninferiority margin of 10%; and a 1-sided test with type I error probability of 0.025. A sample size of 890 (445 per treatment group) was inflated by 15% (1024 subjects) to account for inadvertent repeated enrollment of the same subjects. Repeated enrollments of the same subject were not analyzed.||0.16|0.04|<0.001
73835383|NCT00809146|147220076|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.7|1.34||||||||1.34|0.70|
73835384|NCT00809146|147220077|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||||0.98|0.79|
73835385|NCT00809146|147220078|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.65|0.95||||||||0.95|0.65|
73835386|NCT00809146|147220079|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.74|1.56||||||All participants were included in this analysis of rate of recurrence because this is the most clinically relevant denominator, although, by definition, only participants who stopped could have recurrent seizures.||1.56|0.74|
73835387|NCT00809146|147220080|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.42|1.98||||||||1.98|0.42|
73835388|NCT00809146|147220081|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.99|||||TWO_SIDED|95.0|0.3|10.7||||||||10.70|0.30|
73835389|NCT00809146|147220083|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
73835390|NCT00809146|147220084|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
73835391|NCT01245062|147220103|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.31|0.64||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Investigator-Assessed PFS. HR \<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|||0.64|0.31|<0.0001
73835392|NCT01245062|147220103|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.29|0.6||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Independent Review PFS. HR \<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|||0.60|0.29|<0.0001
73835393|NCT05788328|147220133|OTHER||Ratio of Adjusted Geometric Means|86.5|||||TWO_SIDED|90.0|66.05|113.29|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||113.29|66.05|
73835394|NCT05788328|147220133|OTHER||Ratio of Adjusted Geometric Means|82.64|||||TWO_SIDED|90.0|63.1|108.24|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||108.24|63.10|
73835395|NCT05788328|147220134|OTHER||Ratio of Adjusted Geometric Means|85.65|||||TWO_SIDED|90.0|64.96|112.94|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||112.94|64.96|
73835396|NCT05788328|147220134|OTHER||Ratio of Adjusted Geometric Means|80.81|||||TWO_SIDED|90.0|61.28|106.55|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||106.55|61.28|
73835397|NCT05788328|147220135|OTHER||Ratio of Adjusted Geometric Means|229.11|||||TWO_SIDED|90.0|185.23|283.37|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||283.37|185.23|
73896722|NCT00955201|147326633|SUPERIORITY|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.84
73896723|NCT00955201|147326633|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
73835398|NCT05788328|147220135|OTHER||Ratio of Adjusted Geometric Means|214.73|||||TWO_SIDED|90.0|173.38|265.94|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||265.94|173.38|
73835399|NCT05788328|147220136|OTHER||Ratio of Adjusted Geometric Means|213.05|||||TWO_SIDED|90.0|170.46|266.29|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||266.29|170.46|
73835400|NCT05788328|147220136|OTHER||Ratio of Adjusted Geometric Means|232.32|||||TWO_SIDED|90.0|185.88|290.38|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||290.38|185.88|
73835401|NCT05788328|147220144|OTHER||Ratio of Adjusted Geometric Means|45.25|||||TWO_SIDED|90.0|33.97|60.27|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||60.27|33.97|
73835402|NCT05788328|147220144|OTHER||Ratio of Adjusted Geometric Means|47.44|||||TWO_SIDED|90.0|35.62|63.19|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||63.19|35.62|
73835403|NCT05788328|147220149|OTHER||Ratio of Adjusted Geometric Means|176.39|||||TWO_SIDED|90.0|135.51|229.6|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||229.60|135.51|
73835404|NCT05788328|147220149|OTHER||Ratio of Adjusted Geometric Means|221.62|||||TWO_SIDED|90.0|170.26|288.48|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||288.48|170.26|
73835405|NCT00669331|147220198|SUPERIORITY_OR_OTHER||Rate Ratio Mannitol:Control|0.92||||0.3115|TWO_SIDED|95.0|0.78|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline PE rate as predictors and log of follow-up time as an offset variable|For rate ratio, Mannitol rate is the numerator, Control rate is the denominator|||1.08|0.78|0.3115
73835406|NCT00669331|147220199|SUPERIORITY_OR_OTHER||LS mean difference across the 52 weeks|-2.4||||0.0457|TWO_SIDED|95.0|-4.76|-0.05|||Mixed model repeated measures analysis|Model included treatment, visit, treatment\*visit, region and baseline SGRQ Total score.|difference calculated Mannitol-control. Negative difference is in favour of mannitol since lower scores indicate improved quality of life.|||-0.05|-4.76|0.0457
73835407|NCT00669331|147220200|SUPERIORITY_OR_OTHER||Rate ratio|0.91||||0.2754|TWO_SIDED|95.0|0.77|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline pulmonary exacerbation rate as predictors, log follow-up as offset|Rate ratio is for mannitol vs control.|||1.08|0.77|0.2754
73835408|NCT00669331|147220201|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0218|TWO_SIDED|95.0|0.63|0.96|||Regression, Cox|Cox regression model was stratified by region and baseline PE rate||||0.96|0.63|0.0218
73835409|NCT00669331|147220202|SUPERIORITY_OR_OTHER||Rate ratio|0.88||||0.3602|TWO_SIDED|95.0|0.67|1.16|||Negative binomial model|treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable||Analysed using a negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable||1.16|0.67|0.3602
73835410|NCT00669331|147220203|SUPERIORITY_OR_OTHER||ls mean difference across 52 weeks|2.76||||0.0355|TWO_SIDED|95.0|0.19|5.33|||Mixed Models Analysis|Model includes treatment, visit, treatment\*visit, region and baseline sputum weight (g).|Difference mannitol-control|||5.33|0.19|0.0355
73835411|NCT00669331|147220204|SUPERIORITY_OR_OTHER||LS mean diff across post-baseline visits|-0.44||||0.1159|TWO_SIDED|95.0|-0.99|0.11|||Mixed Models Analysis|Model includes treatment, visit, treatment\*visit, region and baseline ESS score|Negative change indicates an improvement in ESS score. Difference calculated Mannitol - Control.|||0.11|-0.99|0.1159
73835412|NCT00669331|147220205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.56||||0.6677|TWO_SIDED|95.0|-27.01|42.13|||Mixed Models Analysis|Model of absolute change from baseline in FEV1. Model includes terms for treatment, visit, trt\*visit, region and baseline value|ls mean difference Mannitol-Control|||42.13|-27.01|0.6677
73835413|NCT00669331|147220212|SUPERIORITY_OR_OTHER||Rate ratio|0.61||||0.0928|TWO_SIDED|95.0|0.34|1.09|||Negative binomial regression|||||1.09|0.34|0.0928
73835414|NCT01454063|147220217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.577|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001||95.0|0.475|0.678||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS - Placebo) adjusted for randomization strata.||||0.678|0.475|<0.0001
73835415|NCT01454063|147220218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.199|STANDARD_ERROR_OF_MEAN|1.076|<|0.0001||95.0|-7.307|-3.091||p-value based on the generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302-placebo) adjusted for randomization strata.||||-3.091|-7.307|<0.0001
73835416|NCT01454063|147220219|SUPERIORITY_OR_OTHER|||||||0.0514||||||Treatment comparisons based on CMH test adjusting for randomization strata.|Cochran-Mantel-Haenszel|||||||0.0514
73835417|NCT01454063|147220220|SUPERIORITY_OR_OTHER|||||||0.0034||||||Treatment comparisons based on CMH test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.0034
73835418|NCT01454063|147220221|SUPERIORITY_OR_OTHER|||||||0.0963||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata. For subjects without a score due to inability to read the ETDRS chart, the log score will be imputed as 1.6 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.0963
73835419|NCT01454063|147220222|SUPERIORITY_OR_OTHER|||||||0.0532||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.0532
73835420|NCT01454063|147220223|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||<0.0001
73835421|NCT03055195|147220224|OTHER||Proportions Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC versus Placebo SC has been presented.|||23.3|-1.1|
73835422|NCT03055195|147220226|OTHER||Proportion Difference|-1.0|||||TWO_SIDED|90.0|-14.0|12.6|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 4 has been presented.|||12.6|-14.0|
73835423|NCT03055195|147220226|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 8 has been presented.|||23.3|-1.1|
73835424|NCT03055195|147220226|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 12 has been presented.|||23.3|-1.1|
73835425|NCT03055195|147220226|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 16 has been presented.|||23.3|-1.1|
73835426|NCT03055195|147220226|OTHER||Proportion Difference|6.0|||||TWO_SIDED|90.0|-3.3|14.4|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 20 has been presented.|||14.4|-3.3|
73835427|NCT01960842|147220276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.64|||<|0.001|TWO_SIDED|95.0|-5.78|-3.5|||One-sample t-test, 2-sided|||||-3.50|-5.78|<0.001
73835428|NCT01960842|147220277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.58|||<|0.001|TWO_SIDED|95.0|4.21|6.95|||One-sample t-test, 2-sided|||||6.95|4.21|<0.001
73835429|NCT01960842|147220278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0|||<|0.001|TWO_SIDED|95.0|-16.3|-7.7|||One-sample t-test, 2-sided|||||-7.7|-16.3|<0.001
73835430|NCT01960842|147220279|SUPERIORITY_OR_OTHER||Mean change from score = 4|-2.1|STANDARD_DEVIATION|0.77|<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).||||<0.001
73835431|NCT01960842|147220280|SUPERIORITY_OR_OTHER||Mean change from score = 4|-2.0|STANDARD_DEVIATION|0.94|<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).||||<0.001
73835432|NCT01960842|147220281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|||=|0.101|TWO_SIDED|95.0|-4.0|0.4|||One-sample t-test, 2-sided|||||0.4|-4.0|=0.101
73835433|NCT01960842|147220282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1|||=|0.182|TWO_SIDED|95.0|-5.3|1.1|||One-sample t-test, 2-sided|||||1.1|-5.3|=0.182
73835434|NCT01960842|147220283|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|||=|0.032|TWO_SIDED|95.0|-1.9|-0.09|||One-sample t-test, 2-sided|||||-0.09|-1.90|=0.032
73835435|NCT01960842|147220284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.2|||<|0.001|TWO_SIDED|95.0|-27.8|-10.6|||One-sample t-test, 2-sided|||Mobility Domain analysis.||-10.6|-27.8|<0.001
73835436|NCT01960842|147220284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.5|||=|0.059|TWO_SIDED|95.0|-13.3|0.3|||One-sample t-test, 2-sided|||Emotional Well-Being Domain analysis.||0.3|-13.3|=0.059
73835437|NCT01960842|147220284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.5|||=|0.07|TWO_SIDED|95.0|-15.6|0.6|||One-sample t-test, 2-sided|||Stigma Domain analysis.||0.6|-15.6|=0.070
73835438|NCT01960842|147220284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5|||=|0.591|TWO_SIDED|95.0|-7.3|4.2|||One-sample t-test, 2-sided|||Social Support Domain analysis.||4.2|-7.3|=0.591
73835439|NCT01960842|147220284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-20.7|-7.3|||One-sample t-test, 2-sided|||Cognition Domain analysis.||-7.3|-20.7|<0.001
73835440|NCT01960842|147220284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||=|0.67|TWO_SIDED|95.0|-4.2|6.4|||One-sample t-test, 2-sided|||Communication Domain analysis.||6.4|-4.2|=0.670
73835441|NCT01960842|147220284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.8|||<|0.001|TWO_SIDED|95.0|-25.2|-10.3|||One-sample t-test, 2-sided|||Bodily Discomfort Domain analysis.||-10.3|-25.2|<0.001
73835442|NCT01960842|147220285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|||=|0.056|TWO_SIDED|95.0|-9.8|0.1|||One-sample t-test, 2-sided|||||0.1|-9.8|=0.056
73835443|NCT01960842|147220286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||=|0.011|TWO_SIDED|95.0|-1.6|-0.2|||One-sample t-test, 2-sided|||||-0.2|-1.6|=0.011
73835444|NCT01960842|147220287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.001|TWO_SIDED|95.0|-4.4|-1.9|||One-sample t-test, 2-sided|||||-1.9|-4.4|<0.001
73835445|NCT01960842|147220288|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.65|||<|0.001|TWO_SIDED|95.0|-5.83|-3.47|||One-sample t-test, 2-sided|||||-3.47|-5.83|<0.001
73835446|NCT01960842|147220289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.58|||<|0.001|TWO_SIDED|95.0|-5.73|-3.44|||One-sample t-test, 2-sided|||||-3.44|-5.73|<0.001
73835447|NCT00397930|147220298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.3||0.009|TWO_SIDED|||||Between-group differences are expressed as differences in mean Post-Pre change for the global sleep quality PSQI score.|ANCOVA|ANCOVA with post-intervention PSQI score as the outcome, with Group as the factor, and pre-intervention PSQI score as the covariate.|The negative estimated value indicates that the mean Post-Pre change for the YOCAS group was less than that of the Control group.|"H0: There is no statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level.~Ha: There is a statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level."||||0.009
73835448|NCT02391584|147220299|SUPERIORITY||||||<|0.0001||||||p\<0.025 was considered significant.|t-test, 1 sided|||||||<0.0001
73835449|NCT02391584|147220303|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
73835450|NCT02391584|147220304|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
73835451|NCT02391584|147220305|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
73835452|NCT02391584|147220306|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
73835453|NCT03737032|147220319|SUPERIORITY|||||||0.8|||||||ANOVA|||Null hypothesis: post-TBS dmPFC activation will not vary by TBS condition. This is tested using the main effect of condition in a repeated measures model.||||0.80
73835454|NCT03737032|147220320|SUPERIORITY|||||||0.23|||||||ANOVA|Repeated measures ANOVA with time (pre or post), condition (cTBS, iTBS, sham TBS), and time\*condition effects.||Null hypothesis: pre-post change in positive affect will not vary by TBS condition. This is tested using the interaction of time\*condition in a repeated measures model.||||0.23
73835455|NCT03737032|147220321|SUPERIORITY|||||||0.84|||||||ANOVA|||Null hypothesis: post-TBS functional connectivity between the dmPFC and ventral striatum (VS) will not vary by TBS condition. This is tested using the main effect of condition in a repeated measures model.||||0.84
73835456|NCT04676646|147220345|SUPERIORITY||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|95.0|2.89|6.86|||GEE model||An odds ratio greater than 1 indicated increased odds of response on SZC compared to placebo.|||6.86|2.89|<0.001
73835457|NCT04676646|147220346|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.78|7.55|||GEE model||An odds ratio \>1 indicated increased odds of response on SZC compared to placebo.|||7.55|2.78|<0.001
73835458|NCT04676646|147220347|SUPERIORITY||Odds Ratio (OR)|4.33|||<|0.001|TWO_SIDED|95.0|2.5|7.52|||GEE model||An odds ratio greater than 1 indicated increased odds of response on SZC compared to placebo.|||7.52|2.50|<0.001
73835459|NCT04676646|147220348|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001||95.0|0.37|0.71|||Regression, Cox||A hazard ratio less than 1 favors SZC to be associated with a longer time to first hyperkalaemia episode than placebo.|||0.71|0.37|<0.001
73835460|NCT04676646|147220349|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.006|TWO_SIDED|95.0|0.17|0.73|||Regression, Cox||A hazard ratio less than 1 favored SZC to be associated with a longer time to first instance of a decrease of spironolactone dose due to hyperkalaemia than placebo.|||0.73|0.17|0.006
73835461|NCT04676646|147220350|SUPERIORITY||Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|2.84||0.724|TWO_SIDED|95.0|-6.64|4.63|||t-test, 2 sided||A least-squares mean difference greater than 0 favors SZC compared to placebo.|||4.63|-6.64|0.724
73835462|NCT05075772|147220359|OTHER||Ratio of gMeans (%)|46.3|||||TWO_SIDED|90.0|38.3|55.9|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)).~Intra-matched-pair geometric coefficient of variation=28.2."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||55.9|38.3|
73835463|NCT05075772|147220360|OTHER||Ratio of gMeans (%)|26.8|||||TWO_SIDED|90.0|23.2|31.1|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)). Intra-matched-pair geometric coefficient of variation=22.5"|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||31.1|23.2|
73835464|NCT05075772|147220361|OTHER||Ratio of gMeans (%)|47.0|||||TWO_SIDED|90.0|39.0|56.6|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)).~Intra-matched-pair geometric coefficient of variation=27.7."|The statistical model used for the analysis of this secondary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||56.6|39.0|
73835465|NCT04053452|147220380|OTHER||Area under the curve|0.7262|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
73835466|NCT04053452|147220381|OTHER||Area under the curve|0.6667|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
73835467|NCT04053452|147220382|OTHER||Area under the curve|0.7083|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
73835468|NCT04053452|147220383|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.0623|||||TWO_SIDED|95.0|-0.5005|0.4791||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4791|-0.5005|
73835469|NCT04053452|147220383|OTHER|Median at forearm|Kendall's tau correlation coefficient|-0.1628|||||TWO_SIDED|95.0|-0.6503|0.4222||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4222|-0.6503|
73835470|NCT04053452|147220383|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|-0.185|||||TWO_SIDED|95.0|-0.549|0.1829||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.1829|-0.5490|
73835471|NCT04053452|147220383|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.0512|||||TWO_SIDED|95.0|-0.3411|0.5017||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5017|-0.3411|
73835472|NCT04053452|147220383|OTHER|Median at axilla|Kendall's tau correlation coefficient|0.0476|||||TWO_SIDED|95.0|-0.4335|0.5592||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5592|-0.4335|
73835473|NCT04053452|147220383|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.1229|||||TWO_SIDED|95.0|-0.5092|0.304||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3040|-0.5092|
73835474|NCT04053452|147220383|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.0603|||||TWO_SIDED|95.0|-0.3057|0.4137||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4137|-0.3057|
73835475|NCT04053452|147220383|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|0.1059|||||TWO_SIDED|95.0|-0.4028|0.57||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5700|-0.4028|
73835476|NCT04053452|147220383|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|-0.1786|||||TWO_SIDED|95.0|-0.6503|0.2838||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.2838|-0.6503|
73835477|NCT04053452|147220383|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|-0.2396|||||TWO_SIDED|95.0|-0.5714|0.195||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.1950|-0.5714|
73835478|NCT04053452|147220383|OTHER|C6|Kendall's tau correlation coefficient|-0.0671|||||TWO_SIDED|95.0|-0.4667|0.3336||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3336|-0.4667|
73835479|NCT04053452|147220383|OTHER|C7|Kendall's tau correlation coefficient|-0.2134|||||TWO_SIDED|95.0|-0.7018|0.3193||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3193|-0.7018|
73835480|NCT04053452|147220383|OTHER|Vagus|Kendall's tau correlation coefficient|0.0246|||||TWO_SIDED|95.0|-0.3506|0.4596||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4596|-0.3506|
73835481|NCT04053452|147220384|OTHER|Median at wrist|Odds Ratio (OR)|0.7686494||||0.36|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.360
73835482|NCT04053452|147220384|OTHER|Median at forearm|Odds Ratio (OR)|0.9315228||||0.521|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.521
73835483|NCT04053452|147220384|OTHER|Median at cubital fossa|Odds Ratio (OR)|0.7949528||||0.245|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.245
73835484|NCT04053452|147220384|OTHER|Median at humerus|Odds Ratio (OR)|0.8603349||||0.541|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.541
73835485|NCT04053452|147220384|OTHER|Median at axilla|Odds Ratio (OR)|0.8767973||||0.415|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.415
73835486|NCT04053452|147220384|OTHER|Ulnar at wrist|Odds Ratio, log|0.7613965||||0.504|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.504
73835487|NCT04053452|147220384|OTHER|Ulnar at forearm|Odds Ratio (OR)|0.8061505||||0.393|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.393
73835488|NCT04053452|147220384|OTHER|Ulnar at cubital fossa|Odds Ratio (OR)|0.8336885||||0.222|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.222
73835489|NCT04053452|147220384|OTHER|Ulnar at humerus|Odds Ratio (OR)|1.1214848||||0.615|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.615
73835490|NCT04053452|147220384|OTHER|Ulnar at axilla|Odds Ratio (OR)|0.9898411||||0.926|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.926
73835491|NCT04053452|147220384|OTHER|C6|Odds Ratio (OR)|0.9402829||||0.519|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.519
73835492|NCT04053452|147220384|OTHER|C7|Odds Ratio (OR)|0.9347906||||0.379|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.379
73835493|NCT04053452|147220384|OTHER|Vagus|Odds Ratio (OR)|0.8968658||||0.511|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.511
73835494|NCT04053452|147220385|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.057735|||||TWO_SIDED|95.0|-0.4273|0.3293||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.3293|-0.4273|
73835495|NCT04053452|147220385|OTHER|Median at forearm|Kendall's tau correlation coefficient|-0.0359442|||||TWO_SIDED|95.0|-0.548|0.5248||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.5248|-0.5480|
73835496|NCT04053452|147220385|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|0.1429483|||||TWO_SIDED|95.0|-0.1938|0.4763||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.4763|-0.1938|
73835497|NCT04053452|147220385|OTHER|Median at humerus|Kendall's tau correlation coefficient|-0.3955939|||||TWO_SIDED|95.0|-0.6811|-0.0874||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.0874|-0.6811|
73835498|NCT04053452|147220385|OTHER|Median at axilla|Kendall's tau correlation coefficient|-0.3681051|||||TWO_SIDED|95.0|-0.7032|0.1185||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.1185|-0.7032|
73835499|NCT04053452|147220385|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.4938292|||||TWO_SIDED|95.0|-0.7112|-0.1978||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.1978|-0.7112|
73835500|NCT04053452|147220385|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.1304373|||||TWO_SIDED|95.0|-0.2201|0.5014||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.5014|-0.2201|
73835501|NCT04053452|147220385|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|0.3273268|||||TWO_SIDED|95.0|-0.0679|0.6612||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.6612|-0.0679|
73835502|NCT04053452|147220385|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|-0.0552157|||||TWO_SIDED|95.0|-0.4213|0.361||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.3610|-0.4213|
73835503|NCT04053452|147220385|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|-0.1666667|||||TWO_SIDED|95.0|-0.5389|0.2057||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.2057|-0.5389|
73835504|NCT04053452|147220385|OTHER|C6|Kendall's tau correlation coefficient|-0.3194892|||||TWO_SIDED|95.0|-0.6539|0.2288||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.2288|-0.6539|
73835505|NCT04053452|147220385|OTHER|C7|Kendall's tau correlation coefficient|-0.4959498|||||TWO_SIDED|95.0|-0.686|-0.2065||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.2065|-0.6860|
73835506|NCT04053452|147220385|OTHER|Vagus|Kendall's tau correlation coefficient|-0.3228883|||||TWO_SIDED|95.0|-0.6487|0.0||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.0000|-0.6487|
73835507|NCT04053452|147220386|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.1415346|||||TWO_SIDED|95.0|-0.735|0.4247||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4247|-0.7350|
73835508|NCT04053452|147220386|OTHER|Median at forearm|Kendall's tau correlation coefficient|0.1987845|||||TWO_SIDED|95.0|-0.4377|0.8004||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.8004|-0.4377|
73835509|NCT04053452|147220386|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|-0.0789747|||||TWO_SIDED|95.0|-0.5256|0.3778||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.3778|-0.5256|
73835510|NCT04053452|147220386|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.1621509|||||TWO_SIDED|95.0|-0.3591|0.5606||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5606|-0.3591|
73835511|NCT04053452|147220386|OTHER|Median at axilla|Kendall's tau correlation coefficient|0.1499412|||||TWO_SIDED|95.0|-0.3901|0.6374||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.6374|-0.3901|
73835512|NCT04053452|147220386|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.0140441|||||TWO_SIDED|95.0|-0.5773|0.5407||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5407|-0.5773|
73835513|NCT04053452|147220386|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.01383297|||||TWO_SIDED|95.0|-0.5288|0.5485||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5485|-0.5288|
73835514|NCT04053452|147220386|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|-0.2935683|||||TWO_SIDED|95.0|-0.6968|0.2414||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.2414|-0.6968|
73835515|NCT04053452|147220386|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|0.1067521|||||TWO_SIDED|95.0|-0.5204|0.6392||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.6392|-0.5204|
73835516|NCT04053452|147220386|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|0.0549235|||||TWO_SIDED|95.0|-0.4633|0.5594||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5594|-0.4633|
73835517|NCT04053452|147220386|OTHER|C6|Kendall's tau correlation coefficient|-0.2597622|||||TWO_SIDED|95.0|-0.6816|0.1857||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.1857|-0.6816|
73835518|NCT04053452|147220386|OTHER|C7|Kendall's tau correlation coefficient|-0.0129034|||||TWO_SIDED|95.0|-0.4476|0.4025||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4025|-0.4476|
73835519|NCT04053452|147220386|OTHER|Vagus|Kendall's tau correlation coefficient|0.02457737|||||TWO_SIDED|95.0|-0.3506|0.4596||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4596|-0.3506|
73835520|NCT04053452|147220387|OTHER|Median at wrist|Kendall's tau correlation coefficient|0.1704986|||||TWO_SIDED|95.0|-0.395|0.6584||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6584|-0.3950|
73835521|NCT04053452|147220387|OTHER|Median at forearm|Kendall's tau correlation coefficient|0.1704986|||||TWO_SIDED|95.0|-0.395|0.6584||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6584|-0.3950|
73835522|NCT04053452|147220387|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|0.09040847|||||TWO_SIDED|95.0|-0.3821|0.5979||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.5979|-0.3821|
73835523|NCT04053452|147220387|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.02501955|||||TWO_SIDED|95.0|-0.4158|0.479||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4790|-0.4158|
73835524|NCT04053452|147220387|OTHER|Median at axilla|Kendall's tau correlation coefficient|-0.0349215|||||TWO_SIDED|95.0|-0.5033|0.443||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4430|-0.5033|
73835525|NCT04053452|147220387|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.0961|||||TWO_SIDED|95.0|-0.5458|0.4037||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4037|-0.5458|
73835526|NCT04053452|147220387|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|-0.2239171|||||TWO_SIDED|95.0|-0.6514|0.2935||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.2935|-0.6514|
73835527|NCT04053452|147220387|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|-0.0805076|||||TWO_SIDED|95.0|-0.5371|0.2974||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.2974|-0.5371|
73835528|NCT04053452|147220387|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|0.2910126|||||TWO_SIDED|95.0|-0.2791|0.7651||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.7651|-0.2791|
73835529|NCT04053452|147220387|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|0.02342428|||||TWO_SIDED|95.0|-0.4531|0.5267||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.5267|-0.4531|
73835530|NCT04053452|147220387|OTHER|C6|Kendall's tau correlation coefficient|0.06536087|||||TWO_SIDED|95.0|-0.2786|0.4454||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4454|-0.2786|
73896724|NCT00955201|147326633|SUPERIORITY|||||||0.96|||||||ANOVA|||Comparison across groups at baseline.||||0.96
73835531|NCT04053452|147220387|OTHER|C7|Kendall's tau correlation coefficient|0.2207792|||||TWO_SIDED|95.0|-0.2459|0.6708||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6708|-0.2459|
73835532|NCT04053452|147220387|OTHER|Vagus|Kendall's tau correlation coefficient|0.14415|||||TWO_SIDED|95.0|-0.2333|0.4899||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4899|-0.2333|
73835533|NCT04053452|147220388|OTHER|Median at wrist|Odds Ratio (OR)|0.9310743||||0.548|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.548
73835534|NCT04053452|147220388|OTHER|Median at forearm|Odds Ratio (OR)|0.9310743||||0.548|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.548
73835535|NCT04053452|147220388|OTHER|Median at cubital fossa|Odds Ratio (OR)|1.23944918||||0.25|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.250
73835536|NCT04053452|147220388|OTHER|Median at humerus|Odds Ratio (OR)|0.9613236||||0.874|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.874
73835537|NCT04053452|147220388|OTHER|Median at axilla|Odds Ratio (OR)|0.9442314||||0.698|TWO_SIDED|95.0|||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.698
73835538|NCT04053452|147220388|OTHER|Ulnar at wrist|Odds Ratio (OR)|1.193941||||0.665|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.665
73835539|NCT04053452|147220388|OTHER|Ulnar at forearm|Odds Ratio (OR)|1.0524489||||0.82|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.820
73835540|NCT04053452|147220388|OTHER|Ulnar at cubital fossa|Odds Ratio (OR)|1.21669122||||0.193|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.193
73835541|NCT04053452|147220388|OTHER|Ulnar at humerus|Odds Ratio (OR)|1.2994068||||0.314|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.314
73835542|NCT04053452|147220388|OTHER|Ulnar at axilla|Odds Ratio (OR)|1.1015629||||0.405|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.405
73835543|NCT04053452|147220388|OTHER|C6|Odds Ratio (OR)|0.9140133||||0.389|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.389
73835544|NCT04053452|147220388|OTHER|C7|Odds Ratio (OR)|0.7982946||||0.139|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.139
73835545|NCT04053452|147220388|OTHER|Vagus|Odds Ratio (OR)|0.9330042||||0.622|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.622
73835546|NCT04053452|147220389|OTHER|Median at wrist, 3 months|Kendall's tau correlation coefficient|0.2641183|||||TWO_SIDED|95.0|-0.2344|0.7511||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.7511|-0.2344|
73835547|NCT04053452|147220389|OTHER|Median at forearm, 3 months|Kendall's tau correlation coefficient|0.02596308|||||TWO_SIDED|95.0|-0.4859|0.5555||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.5555|-0.4859|
73835548|NCT04053452|147220389|OTHER|Median at cubital fossa, 3 months|Kendall's tau correlation coefficient|0.05162687|||||TWO_SIDED|95.0|-0.3342|0.417||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4170|-0.3342|
73835549|NCT04053452|147220389|OTHER|Median at humerus, 3 months|Kendall's tau correlation coefficient|-0.1714461|||||TWO_SIDED|95.0|-0.6473|0.2723||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.2723|-0.6473|
73835550|NCT04053452|147220389|OTHER|Median at axilla, 3 months|Kendall's tau correlation coefficient|-0.0531775|||||TWO_SIDED|95.0|-0.583|0.4451||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4451|-0.5830|
73835551|NCT04053452|147220389|OTHER|Ulnar at wrist, 3 months|Kendall's tau correlation coefficient|0.1371924|||||TWO_SIDED|95.0|-0.3592|0.6944||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.6944|-0.3592|
73835552|NCT04053452|147220389|OTHER|Ulnar at forearm, 3 months|Kendall's tau correlation coefficient|-0.0134595|||||TWO_SIDED|95.0|-0.5145|0.4627||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4627|-0.5145|
73896725|NCT00955201|147326633|SUPERIORITY|||||||0.86|||||||ANOVA|||Comparison across groups at 12-wks.||||0.86
73896726|NCT00955201|147326633|SUPERIORITY|||||||0.92|||||||ANOVA|||Comparison across groups at 24-wks.||||0.92
73835553|NCT04053452|147220389|OTHER|Ulnar at cubital fossa, 3 months|Kendall's tau correlation coefficient|0.01313517|||||TWO_SIDED|95.0|-0.5056|0.4833||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4833|-0.5056|
73835554|NCT04053452|147220389|OTHER|Ulnar at humerus, 3 months|Kendall's tau correlation coefficient|-0.1196495|||||TWO_SIDED|95.0|-0.5876|0.3467||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.3467|-0.5876|
73835555|NCT04053452|147220389|OTHER|Ulnar at axilla, 3 months|Kendall's tau correlation coefficient|0.0|||||TWO_SIDED|95.0|-0.3682|0.3885||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.3885|-0.3682|
73835556|NCT04053452|147220389|OTHER|C6, 3 months|Kendall's tau correlation coefficient|0.1194695|||||TWO_SIDED|95.0|-0.422|0.6686||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.6686|-0.4220|
73835557|NCT04053452|147220389|OTHER|C7, 3 months|Kendall's tau correlation coefficient|-0.0593456|||||TWO_SIDED|95.0|-0.5651|0.454||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4540|-0.5651|
73835558|NCT04053452|147220389|OTHER|Vagus, 3 months|Kendall's tau correlation coefficient|-0.1920694|||||TWO_SIDED|95.0|-0.549|0.238||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.238|-0.5490|
73835559|NCT04053452|147220389|OTHER|Median at wrist, 6 months|Kendall's tau correlation coefficient|0.3150905|||||TWO_SIDED|||||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||||
73835560|NCT04053452|147220389|OTHER|Median at forearm, 6 months|Kendall's tau correlation coefficient|0.1203751|||||TWO_SIDED|||||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||||
73835561|NCT04053452|147220389|OTHER|Median at cubital fossa, 6 months|Kendall's tau correlation coefficient|0.2526605|||||TWO_SIDED|95.0|-0.1865|0.643||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6430|-0.1865|
73835562|NCT04053452|147220389|OTHER|Median at humerus, 6 months|Kendall's tau correlation coefficient|-0.073601|||||TWO_SIDED|95.0|-0.5806|0.4223||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.4223|-0.5806|
73835563|NCT04053452|147220389|OTHER|Median at axilla, 6 months|Kendall's tau correlation coefficient|0.01369735|||||TWO_SIDED|95.0|-0.5619|0.5236||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5236|-0.5619|
73835564|NCT04053452|147220389|OTHER|Ulnar at wrist, 6 months|Kendall's tau correlation coefficient|0.2685663|||||TWO_SIDED|95.0|-0.2488|0.7683||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.7683|-0.2488|
73835565|NCT04053452|147220389|OTHER|Ulnar at forearm, 6 months|Kendall's tau correlation coefficient|0.1802776|||||TWO_SIDED|95.0|-0.2573|0.6027||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6027|-0.2573|
73835566|NCT04053452|147220389|OTHER|Ulnar at cubital fossa, 6 months|Kendall's tau correlation coefficient|0.2571327|||||TWO_SIDED|95.0|-0.2595|0.6227||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6227|-0.2595|
73835567|NCT04053452|147220389|OTHER|Ulnar at humerus, 6 months|Kendall's tau correlation coefficient|-0.0684867|||||TWO_SIDED|95.0|-0.5757|0.3944||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.3944|-0.5757|
73835568|NCT04053452|147220389|OTHER|Ulnar at axilla, 6 months|Kendall's tau correlation coefficient|0.1929429|||||TWO_SIDED|95.0|-0.1828|0.555||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5550|-0.1828|
73835569|NCT04053452|147220389|OTHER|C6, 6 months|Kendall's tau correlation coefficient|0.1975146|||||TWO_SIDED|95.0|-0.3557|0.7344||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.7344|-0.3557|
73835570|NCT04053452|147220389|OTHER|C7, 6 months|Kendall's tau correlation coefficient|-0.0754722|||||TWO_SIDED|95.0|-0.615|0.5083||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5083|-0.6150|
73835571|NCT04053452|147220389|OTHER|Vagus, 6 months|Kendall's tau correlation coefficient|-0.0706753|||||TWO_SIDED|95.0|-0.5042|0.3963||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.3963|-0.5042|
73835572|NCT01421134|147220390|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|1.37|<|0.0001|TWO_SIDED|95.0|-10.2|-4.8|||Mixed Models Analysis|||||-4.8|-10.2|<0.0001
73835573|NCT01421134|147220391|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.157|<|0.0001|TWO_SIDED|95.0|-0.96|-0.34|||Mixed Models Analysis|||||-0.34|-0.96|<0.0001
73835574|NCT01421134|147220392|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.1|-1.1|||Mixed Models Analysis|||||-1.1|-3.1|<0.0001
73835575|NCT01421134|147220393|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.2|-2.4|||ANCOVA|||||-2.4|-7.2|0.0001
73835576|NCT01421134|147220394|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-6.1|-2.9|||ANCOVA|||||-2.9|-6.1|<0.0001
73835577|NCT01421134|147220395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.615|||<|0.0001|TWO_SIDED|95.0|3.251|13.459|||Regression, Logistic||Odds Ratio was based on a logistic regression of response, with treatment group, baseline MADRS total score, and pooled center as fixed effects.|||13.459|3.251|<0.0001
73835578|NCT01421134|147220396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.27|||<|0.0001|TWO_SIDED|95.0|2.105|8.663|||Regression, Logistic|||||8.663|2.105|<0.0001
73835579|NCT02734147|147220397|OTHER|||||||0.631|||||||Other|||||||0.631
73835580|NCT02734147|147220398|OTHER|||||||0.64|||||||Other|||||||0.640
73835581|NCT02734147|147220399|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
73835582|NCT02734147|147220400|SUPERIORITY|||||||0.655|||||||Fisher Exact|||||||0.655
73835583|NCT02734147|147220401|SUPERIORITY|||||||0.133|||||||Fisher Exact|||||||0.133
73835584|NCT02734147|147220402|OTHER|||||||0.566|||||||Other|||||||0.566
73835585|NCT02734147|147220403|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
73835586|NCT04098302|147220441|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
73835587|NCT04098302|147220442|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|||||||0.019
73835588|NCT04098302|147220443|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
73835589|NCT04098302|147220444|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
73835590|NCT01810952|147220445|SUPERIORITY_OR_OTHER|||||||0.35||||||This is the p-value for Day 5|t-test, 2 sided|||||||0.35
73835591|NCT01810952|147220446|SUPERIORITY_OR_OTHER|||||||0.65|||||||Chi-squared|||||||0.65
73835592|NCT01810952|147220447|SUPERIORITY_OR_OTHER|||||||0.06||||||Comparison of the 5 day averages resulted in a p-value of 0.06.|t-test, 2 sided|||Daily values for each protocol were compared using t-tests.||||0.06
73835593|NCT01810952|147220448|SUPERIORITY_OR_OTHER||difference in binomial proportions|||||0.795||||||Comparison of the number of participants in each group with glucose value \<70 mg/dL resulted in p-value 0.795.|Chi-squared|||||||0.795
73835594|NCT01810952|147220449|SUPERIORITY_OR_OTHER|||||||0.055||||||Comparison between groups of percent of glucose values \>180 mg/dL.|Chi-squared|||Values in each group were compared by Chi squared.||||0.055
73835595|NCT01668537|147220471|NON_INFERIORITY|The non-inferiority margin to show that the FD formulation is non-inferior to the LF formulation in terms of ELISA GMTs at the peak visit (Week 6) was predefined as '1.5' for the GMT ratio (LF/FD). Non-inferiority is demonstrated if the upper 95% CI of the GMT ratio (LF/FD) is entirely below 1.5|GMT ratio (LF/FD)|0.796|||||TWO_SIDED|95.0|0.707|0.896||||||||0.896|0.707|
73835596|NCT05064800|147220489|OTHER||Ratio of Adjusted Geometric Means|233.06|||||TWO_SIDED|90.0|172.14|315.54|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed Cmax of dabigatran was analyzed using mixed effect model with treatment, period, sequence as fixed effects; participant within sequence as a random effect. Estimates of the adjusted mean differences(AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||315.54|172.14|
73835597|NCT05064800|147220490|OTHER||Ratio of Adjusted Geometric Means|169.07|||||TWO_SIDED|90.0|135.25|211.35|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed AUCinf of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||211.35|135.25|
73835598|NCT05064800|147220491|OTHER||Ratio of Adjusted Geometric Means|160.05|||||TWO_SIDED|90.0|119.19|214.9|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed AUClast of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model.The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||214.90|119.19|
73835599|NCT05064800|147220492|OTHER||Ratio of Adjusted Geometric Means|171.91|||||TWO_SIDED|90.0|127.51|231.77|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed Cmax of dabigatran was analyzed using mixed effect model with treatment, period, sequence as fixed effects; participant within sequence as a random effect. Estimates of the adjusted mean differences(AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||231.77|127.51|
73835600|NCT05064800|147220493|OTHER||Ratio of Adjusted Geometric Means|169.07|||||TWO_SIDED|90.0|135.25|211.35|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed AUCinf of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||211.35|135.25|
73835601|NCT05064800|147220494|OTHER||Ratio of Adjusted Geometric Means|160.05|||||TWO_SIDED|90.0|119.19|214.9|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed AUClast of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model.The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||214.90|119.19|
73835602|NCT04477486|147220509|SUPERIORITY|Comparing against a historical reference of 12.5% CRR.|||||<|0.001|||||||Exact Binomial Distribution|||||||<0.001
73835603|NCT02864914|147220547|OTHER||Adjusted incidence rate ratio|0.77|||||TWO_SIDED|95.0|0.5|1.19|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.19|0.50|
73896727|NCT00955201|147326634|SUPERIORITY|||||||0.03||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.03
73896728|NCT00955201|147326634|SUPERIORITY|||||||0.29||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.29
73896729|NCT00955201|147326634|SUPERIORITY|||||||0.36||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.36
73896730|NCT00955201|147326634|SUPERIORITY|||||||0.15||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.15
73896731|NCT00955201|147326634|SUPERIORITY|||||||0.2||||||ANOVA|ANOVA|||Comparison of pre- and post-responses across groups at baseline.||||0.20
73896732|NCT00955201|147326634|SUPERIORITY|||||||0.51||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 12 wks.||||0.51
73896733|NCT00955201|147326634|SUPERIORITY|||||||0.59||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 24 wks.||||0.59
73896734|NCT00955201|147326635|SUPERIORITY|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||1.00
73896735|NCT00955201|147326635|SUPERIORITY|||||||0.01||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||0.01
73896736|NCT00955201|147326635|SUPERIORITY|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||1.00
73896737|NCT00955201|147326635|SUPERIORITY|||||||0.98||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||0.98
73896738|NCT00955201|147326635|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||Comparison across groups at baseline||||0.96
73896739|NCT00955201|147326635|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||Comparison across groups at 12-wks||||0.06
73896740|NCT00955201|147326635|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||Comparison across groups at 24-wks||||0.14
73896741|NCT00955201|147326636|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
73896742|NCT00955201|147326636|SUPERIORITY|||||||0.36||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.36
73896743|NCT00955201|147326636|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
73896744|NCT00955201|147326636|SUPERIORITY|||||||0.46||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.46
73896745|NCT00955201|147326636|SUPERIORITY|||||||0.14|||||||ANOVA|||Comparison across groups at baseline.||||0.14
73896746|NCT00955201|147326636|SUPERIORITY|||||||0.05|||||||ANOVA|||Comparison across groups at 12 wks.||||0.05
73896747|NCT00955201|147326636|SUPERIORITY|||||||0.01|||||||ANOVA|||Comparison across groups at 24 wks.||||0.01
73896748|NCT00955201|147326637|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
73896749|NCT00955201|147326637|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
73896750|NCT00955201|147326637|SUPERIORITY|||||||0.67||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.67
73896751|NCT00955201|147326637|SUPERIORITY|||||||0.55||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.55
73896752|NCT00955201|147326637|SUPERIORITY|||||||0.4||||||Tukey's multiple comparisons test:|ANOVA|||Comparison across groups at baseline.||||0.40
73896753|NCT00955201|147326637|SUPERIORITY|||||||0.47|||||||ANOVA|||Comparison across groups at 12 wks.||||0.47
73896754|NCT00955201|147326637|SUPERIORITY|||||||0.43|||||||ANOVA|||Comparison across groups at 24 wks.||||0.43
73896755|NCT00955201|147326638|SUPERIORITY|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.84
73896756|NCT00955201|147326638|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
73896757|NCT00955201|147326638|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.94
73896758|NCT00955201|147326638|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.94
73896759|NCT00955201|147326638|SUPERIORITY|||||||0.88|||||||ANOVA|||Comparison across groups at baseline.||||0.88
73896760|NCT00955201|147326638|SUPERIORITY|||||||0.48|||||||ANOVA|||Comparison across groups at 12 wks.||||0.48
73896761|NCT00955201|147326638|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.||||0.38
73896762|NCT00955201|147326639|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
73896763|NCT00955201|147326639|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
73896764|NCT00955201|147326639|SUPERIORITY|||||||0.51||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.51
73896765|NCT00955201|147326639|SUPERIORITY|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.89
73896766|NCT00955201|147326639|SUPERIORITY|||||||0.46|||||||ANOVA|||Comparison across groups at baseline.||||0.46
73896767|NCT00955201|147326639|SUPERIORITY|||||||0.72|||||||ANOVA|||Comparison across groups at 12 wks.||||0.72
73896768|NCT00955201|147326639|SUPERIORITY|||||||0.22|||||||ANOVA|||Comparison across groups at 24wks.||||0.22
73896769|NCT00955201|147326640|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
73896770|NCT00955201|147326640|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.99
73896771|NCT00955201|147326640|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
73896772|NCT00955201|147326640|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.95
73896773|NCT00955201|147326640|SUPERIORITY|||||||0.39|||||||ANOVA|||Comparison across groups at baseline.||||0.39
73896774|NCT00955201|147326640|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at 12-wks.||||0.59
73896775|NCT00955201|147326640|SUPERIORITY|||||||0.29|||||||ANOVA|||Comparison across groups at 24-wks.||||0.29
73896776|NCT00955201|147326641|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time||||0.97
73896777|NCT00955201|147326641|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
73896778|NCT00955201|147326641|SUPERIORITY|||||||0.09||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.09
73896779|NCT00955201|147326641|SUPERIORITY|||||||0.05||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.05
73896780|NCT00955201|147326641|SUPERIORITY|||||||0.11|||||||ANOVA|||Comparison across groups at baseline.||||0.11
73896781|NCT00955201|147326641|SUPERIORITY|||||||0.41|||||||ANOVA|||Comparison across groups at 12-wks.||||0.41
73896782|NCT00955201|147326641|SUPERIORITY|||||||0.03|||||||ANOVA|||Comparison across groups at 24-wks.||||0.03
73896783|NCT00955201|147326642|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.95
73835604|NCT02864914|147220547|OTHER||Adjusted incidence rate ratio|0.55|||||TWO_SIDED|95.0|0.23|1.32|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.32|0.23|
73835605|NCT02864914|147220547|OTHER||Adjusted incidence rate ratio|0.86|||||TWO_SIDED|95.0|0.52|1.41|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.41|0.52|
73835606|NCT02864914|147220548|OTHER||Adjusted incidence rate ratio|0.54|||||TWO_SIDED|95.0|0.41|0.73|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.73|0.41|
73835607|NCT02864914|147220548|OTHER||Adjusted incidence rate ratio|0.41|||||TWO_SIDED|95.0|0.3|0.55|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.55|0.30|
73835608|NCT02864914|147220548|OTHER||Adjusted incidence rate ratio|0.69|||||TWO_SIDED|95.0|0.45|1.05|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.05|0.45|
73835609|NCT02864914|147220548|OTHER||Adjusted incidence rate ratio|0.41|||||TWO_SIDED|95.0|0.2|0.86|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.86|0.20|
73835610|NCT02864914|147220548|OTHER||Adjusted incidence rate ratio|0.65|||||TWO_SIDED|95.0|0.56|0.76|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.76|0.56|
73835611|NCT02864914|147220549|OTHER||Adjusted incidence rate ratio|2.19|||||TWO_SIDED|95.0|1.74|2.76|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||2.76|1.74|
73835612|NCT02864914|147220549|OTHER||Adjusted incidence rate ratio|2.78|||||TWO_SIDED|95.0|1.77|4.36|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.36|1.77|
73835613|NCT02864914|147220549|OTHER||Adjusted incidence rate ratio|2.14|||||TWO_SIDED|95.0|1.11|4.12|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.12|1.11|
73835614|NCT02864914|147220549|OTHER||Adjusted incidence rate ratio|1.99|||||TWO_SIDED|95.0|1.48|2.66|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||2.66|1.48|
73896784|NCT00955201|147326642|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
73896785|NCT00955201|147326642|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
73896786|NCT00955201|147326642|SUPERIORITY|||||||0.48||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.48
73896787|NCT00955201|147326642|SUPERIORITY|||||||0.58|||||||ANOVA|||Comparison across groups at baseline.||||0.58
73896788|NCT00955201|147326642|SUPERIORITY|||||||0.5|||||||ANOVA|||Comparison across groups at 12-wks.||||0.50
73896789|NCT00955201|147326642|SUPERIORITY|||||||0.33|||||||ANOVA|||Comparison across groups at 24-wks.||||0.33
73835615|NCT02864914|147220550|OTHER||Adjusted incidence rate ratio|0.51|||||TWO_SIDED|95.0|0.37|0.72|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.72|0.37|
73835616|NCT02864914|147220551|OTHER||Adjusted incidence rate ratio|4.04|||||TWO_SIDED|95.0|3.46|4.71|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.71|3.46|
73835617|NCT02864914|147220552|OTHER||Adjusted incidence rate ratio|3.24|||||TWO_SIDED|95.0|2.81|3.74|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||3.74|2.81|
73835618|NCT02864914|147220553|OTHER||Adjusted incidence rate ratio|0.7|||||TWO_SIDED|95.0|0.56|0.88|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.88|0.56|
73835619|NCT02864914|147220553|OTHER||Adjusted incidence rate ratio|0.5|||||TWO_SIDED|95.0|0.29|0.85|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.85|0.29|
73835620|NCT02864914|147220553|OTHER||Adjusted incidence rate ratio|0.66|||||TWO_SIDED|95.0|0.34|1.29|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.29|0.34|
73835621|NCT02864914|147220553|OTHER||Adjusted incidence rate ratio|0.77|||||TWO_SIDED|95.0|0.61|0.97|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.97|0.61|
73835622|NCT02864914|147220554|OTHER||Adjusted incidence rate ratio|0.53|||||TWO_SIDED|95.0|0.43|0.65|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.65|0.43|
73835623|NCT02864914|147220555|OTHER||Adjusted incidence rate ratio|4.04|||||TWO_SIDED|95.0|3.44|4.75|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.75|3.44|
73835624|NCT02864914|147220556|OTHER||Adjusted incidence rate ratio|3.34|||||TWO_SIDED|95.0|2.83|3.95|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||3.95|2.83|
73835625|NCT01487161|147220577|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.1249|TWO_SIDED|90.0|-1.2|0.2|||Longitudinal mixed effect model|||||0.2|-1.2|0.1249
73835626|NCT01487161|147220578|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2002|TWO_SIDED|90.0|-1.1|0.3|||Longitudinal mixed effect model|||||0.3|-1.1|0.2002
73835627|NCT01487161|147220579|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5541|TWO_SIDED|90.0|-0.7|0.8|||Longitudinal mixed effect model|||||0.8|-0.7|0.5541
73835628|NCT00541775|147220607|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<=|0.001||95.0|-0.7|-0.32|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-0.32|-0.70|<=0.001
73896790|NCT00955201|147326643|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
73896791|NCT00955201|147326643|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
73835629|NCT00541775|147220608|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.8|STANDARD_ERROR_OF_MEAN|5.0|<=|0.001||95.0|-27.6|-8.1|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-8.1|-27.6|<=0.001
73835630|NCT00541775|147220609|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.5|STANDARD_ERROR_OF_MEAN|7.9|<=|0.001||95.0|-46.0|-15.0|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-15.0|-46.0|<=0.001
73835631|NCT00032487|147220610|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis tested was for equivalence. We assumed 86% power with 21% of effect size and the sample size 1700 with 5% drop out rate.|Cox Proportional Hazard|0.79|||<|0.05|TWO_SIDED|95.0|0.79|0.99|||Log Rank|||It was hypothesized 21% reduction in intensive glycemic control group compared to standard control group on primary cardiovascular composite outcomes.||.99|.79|<0.05
73835632|NCT02641353|147220640|OTHER||Geometric Mean Ratio|84.9|||||TWO_SIDED|90.0|77.3|93.2|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an analysis of variance (ANOVA) model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.||93.2|77.3|
73835633|NCT02641353|147220640|OTHER||Geometric Mean Ratio|78.2|||||TWO_SIDED|90.0|71.2|86.0|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.||86.0|71.2|
73835634|NCT02641353|147220641|OTHER||Geometric Mean Ratio|87.6|||||TWO_SIDED|90.0|83.0|92.5|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.||92.5|83.0|
73835635|NCT02641353|147220641|OTHER||Geometric Mean Ratio|115.3|||||TWO_SIDED|90.0|109.2|121.7|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.||121.7|109.2|
73835636|NCT02641353|147220642|OTHER||Geometric Mean Ratio|87.8|||||TWO_SIDED|90.0|83.2|92.6|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.||92.6|83.2|
73835637|NCT02641353|147220642|OTHER||Geometric Mean Ratio|115.0|||||TWO_SIDED|90.0|109.0|121.7|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.||121.7|109.0|
73835638|NCT02641353|147220643|OTHER||Median Difference|0.25||||0.1508|TWO_SIDED|90.0|0.0|0.5|||Wilcoxon signed-rank test||Median difference (Treatment B - Treatment A) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% confidence interval (CI) of the median difference were calculated from the Hodges-Lehrmann estimate.||0.50|0.00|0.1508
73835639|NCT02641353|147220643|OTHER||Median Difference|2.25|||<|0.0001|TWO_SIDED|90.0|1.27|3.25|||Wilcoxon signed-rank test||Median difference (Treatment C - Treatment B) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.25|1.27|<0.0001
73835640|NCT03259308|147220650|SUPERIORITY|||||||0.027|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.027
73835641|NCT03259308|147220650|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.014
73835642|NCT03259308|147220651|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.001
73835643|NCT03259308|147220651|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.003
73835644|NCT03259308|147220652|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
73835645|NCT03259308|147220652|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
73835646|NCT03259308|147220653|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
73835647|NCT03259308|147220653|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
73835648|NCT03259308|147220654|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.002
73835649|NCT03259308|147220654|SUPERIORITY|||||||0.017|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.017
73896792|NCT00955201|147326643|SUPERIORITY|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.88
73896793|NCT00955201|147326643|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
73896794|NCT00955201|147326643|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at baseline.||||0.38
73896795|NCT00955201|147326643|SUPERIORITY|||||||0.55|||||||ANOVA|||Comparison across groups at 12-wks.||||0.55
73896796|NCT00955201|147326643|SUPERIORITY|||||||0.37|||||||ANOVA|||Comparison across groups at 24-wks||||0.37
73896797|NCT00955201|147326644|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
73896798|NCT00955201|147326644|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
73896799|NCT00955201|147326644|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
73896800|NCT00955201|147326644|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time.||||1.00
73835650|NCT06025695|147220677|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit (LL) of the two-sided asymptotic standardized 95% confidence interval (CI) for the difference in seroconversion rate between the HRV PCV-free group and HRV group is greater than or equal to -10%.|Difference in seroconversion rate|-3.73|||||TWO_SIDED|95.0|-6.93|-0.55|||||The asymptotic standardized 95% CI for the difference in seroconversion rate between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of seroconversion rates 1 month post-Dose 2.||-0.55|-6.93|
73835651|NCT06025695|147220678|NON_INFERIORITY|NI was to be demonstrated if the LL of the two-sided 95% CI for the ratio of anti-RV IgA Ab GMC between the HRV PCV-free group and HRV group is greater than or equal to 0.67.|GMC Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.84|||||The comparison is done using the group GMC ratio (HRV PCV-free/HRV) (ANOVA model applied to the log10-transformed titers). The ANOVA model included the group as a fixed effect.|To demonstrate the non-inferiority of the HRV PCV-free Group as compared to HRV Group in terms of serum anti-RV IgA Ab concentrations 1 month post-Dose 2.||0.84|0.60|
73835652|NCT06025695|147220679|NON_INFERIORITY|NI was to be demonstrated if the LL of the two-sided asymptotic standardized 95% CI for the difference in the percentage between the HRV PCV-free group and HRV group is greater than or equal to -10%.|Difference in percentage|-6.37|||||TWO_SIDED|95.0|-10.81|-1.92|||||The asymptotic standardized 95% CI for the difference in in the percentage between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of percentage of participants with anti-RV IgA antibody concentrations \>=90 U/mL 1 month post-Dose 2.||-1.92|-10.81|
73835653|NCT03834883|147220683|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
73835654|NCT03834883|147220684|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
73835655|NCT03834883|147220685|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
73835656|NCT03834883|147220686|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
73835657|NCT03834883|147220687|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
73835658|NCT03834883|147220688|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
73835659|NCT03834883|147220690|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||||||0.015
73835660|NCT03834883|147220691|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
73835661|NCT03834883|147220692|SUPERIORITY|||||||0.017|||||||Mixed Models Analysis|||||||0.017
73835662|NCT03834883|147220693|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||0.83
73835663|NCT03834883|147220694|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
73835664|NCT05675020|147220708|OTHER|The descriptive analysis yields frequencies and percentages for categorical variables. The statistical analysis was conducted using IBM SPSS V27.0. We analyzed the percentage of correct responses for knowledge survey questions from pre- and post-intervention survey responses.|||||||||||||||||Participant data was collected from the REDCap pre- and post-intervention questionnaires completed by the adolescents and parents/legal guardians that participated in the project. Data was collected from October to December 2022. The sample size was nine parent-adolescent dyads. Descriptive analysis was used to assess differences in sociodemographic variables, including age, gender, race, material status, employment status, salary, height, and weight. The descriptive analysis yields frequencies and percentages for categorical variables. The statistical analysis was conducted using IBM SPSS V27.0.|||
73835665|NCT05890586|147220729|SUPERIORITY|The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.86|1.07|||||Hazard ratios greater than one favored the active intervention for a faster time to recovery.|||1.07|0.86|
73835666|NCT05890586|147220730|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.03|2.88|||||Low event rate precluded covariate adjustment.|||2.88|0.03|
73835667|NCT05890586|147220733|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.7|||||Hazard ratios less than one favor the active intervention of inhaled fluticasone furoate. The interval is a highest density credible interval.|The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.||1.7|0.6|
73835668|NCT05890586|147220734|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.74|1.98|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||1.98|0.74|
73835669|NCT05890586|147220735|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.53|2.06|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||2.06|0.53|
73835670|NCT05890586|147220736|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|0.74|2.22|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||2.22|0.74|
73835671|NCT05890586|147220737|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.51|0.83|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||0.83|0.51|
73896801|NCT00955201|147326644|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||Comparison across groups at baseline||||0.81
73896802|NCT00955201|147326644|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Comparison across groups at 12-wks||||0.60
73835672|NCT05890586|147220737|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.7|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.21|0.70|
73835673|NCT05890586|147220737|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.55|1.03|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.03|0.55|
73835674|NCT05890586|147220737|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.68|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.39|0.68|
73835675|NCT05890586|147220738|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|1.04|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.60|1.04|
73835676|NCT05890586|147220738|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.98|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.51|0.98|
73835677|NCT05890586|147220738|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.84|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.35|0.84|
73835678|NCT05890586|147220738|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.92|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.47|0.92|
73835679|NCT05890586|147220739|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.8|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.29|0.80|
73835680|NCT05890586|147220739|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.84|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.47|0.84|
73835681|NCT05890586|147220739|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.8|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.46|0.80|
73835682|NCT05890586|147220739|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.77|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.44|0.77|
73835683|NCT05890586|147220740|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.16|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.16|0.70|
73835684|NCT05890586|147220740|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.63|1.1|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.10|0.63|
73835685|NCT05890586|147220740|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.54|0.99|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||0.99|0.54|
73835686|NCT05890586|147220740|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.66|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.18|0.66|
73896803|NCT00955201|147326644|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||Comparison across groups at 24-wks||||0.99
73896804|NCT00955201|147326645|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.||||0.59
73896805|NCT00955201|147326646|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
73835687|NCT05890586|147220741|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.85|1.37|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.37|0.85|
73835688|NCT05890586|147220741|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.85|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.44|0.85|
73835689|NCT05890586|147220741|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.7|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.24|0.70|
73835690|NCT05890586|147220741|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.78|1.37|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.37|0.78|
73835691|NCT05890586|147220742|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.68|1.05|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.05|0.68|
73835692|NCT05890586|147220742|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.7|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.11|0.70|
73835693|NCT05890586|147220742|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.21|0.72|
73835694|NCT05890586|147220742|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.29|0.75|
73835695|NCT05890586|147220743|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio, log|1.3|||||TWO_SIDED|95.0|1.05|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.60|1.05|
73835696|NCT05890586|147220743|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|1.0|1.52|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.52|1.00|
73835697|NCT05890586|147220743|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.27|0.84|
73835698|NCT05890586|147220743|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.21|0.80|
73835699|NCT05890586|147220744|SUPERIORITY||Difference in model estimate time unwell|-0.07|||||TWO_SIDED|95.0|-0.43|0.31|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.31|-0.43|
73835700|NCT05890586|147220745|SUPERIORITY||Difference in model estimated means|0.08|||||TWO_SIDED|95.0|-0.37|0.52|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.52|-0.37|
73835701|NCT02802865|147220763|SUPERIORITY||Rate ratio|1.8||||0.007|TWO_SIDED|95.0|1.18|2.75|||Chi-squared, Corrected|||||2.75|1.18|0.007
73835702|NCT02802865|147220764|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
73835703|NCT02802865|147220765|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
73835704|NCT02802865|147220766|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
73835705|NCT02802865|147220767|SUPERIORITY|||||||0.709|||||||Chi-squared|||This study was not powered to detect significant between-group differences for this conception.||||0.709
73835706|NCT02802865|147220768|SUPERIORITY|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for clinical pregnancy.||||0.356
73835707|NCT02802865|147220770|SUPERIORITY|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for live birth.||||0.356
73835708|NCT02802865|147220771|SUPERIORITY|||||||0.486|||||||Chi-squared, Corrected|||This study was not powered to detect significant between-group differences for pregnancy loss.||||0.486
73835709|NCT01967277|147220821|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||H0: µL ≤ µs Versus Ha: µL \> µs||||<0.001
73835710|NCT01028560|147220831|OTHER||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.22||0.38|TWO_SIDED|95.0|-0.24|0.63|||Mixed Models Analysis||The above is the slope for immunotherapy group . The (quadratic) slope is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with a median score values.||0.63|-0.24|0.38
73835711|NCT01028560|147220831|OTHER||Slope|0.55|STANDARD_ERROR_OF_MEAN|0.22||0.013|TWO_SIDED|95.0|0.11|0.99|||Mixed Models Analysis|The above (quadratic) slope is for control group|The above is the (quadratic) slope is for control group and is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with median score values.||0.99|0.11|0.013
73835712|NCT01028560|147220831|OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|4.97||0.978|TWO_SIDED|95.0|-11.76|12.03||Post estimation means were tested between the intervention arms after LME model at year 1 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||12.03|-11.76|0.978
73835713|NCT01028560|147220831|OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|5.89||0.77|TWO_SIDED|95.0|-15.83|12.38||Post estimation means were tested between the intervention arms after LME model at year 2 and the p- value was unadjusted p value|contrast testing post mixed model]||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||12.38|-15.83|0.77
73835714|NCT01028560|147220831|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|7.39||0.8|TWO_SIDED|95.0|-19.54|15.84||Post estimation means were tested between the intervention arms after LME model at year 3 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||15.84|-19.54|0.80
73835715|NCT01028560|147220832|SUPERIORITY|||||||0.677||||||Chi-square test (proportion of new sensitizations versus unchanged or lost sensitizations in each group, intention-to treat analysis).|Chi-squared|||||||0.677
73835716|NCT01028560|147220833|SUPERIORITY||Slope|0.56||||0.546|TWO_SIDED|95.0|-2.18|3.29||Test of parallelism (group x time) hypothesis P-value.|covariance pattern (rep. measure) model|Within group difference p-values ( baseline vs 3-years) in control and intervention arm were 0.56 and 0.20 respectively.|The estimated slope reported is for year 3 from the covariance pattern model with autoregressive covariance structure.|Covariance Pattern Model with autoregressive covariance structure with REML (Restricted Estimation of Maximum Likelihood) with time and role as categorical variable was modeled.||3.29|-2.18|0.5460
73835717|NCT01028560|147220834|SUPERIORITY||Rate ratio|1.27||||0.289|TWO_SIDED|95.0|0.82|1.96||Poisson regression model for treatment arm adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst and the time period contributed by each child in years were fitted as offset.|Poisson regression|Poisson regression model with robust variance with contributed person years used as offset was modeled.||Null hypothesis = Incidence rate of CSB in each group are same. Poisson regression adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst.||1.96|0.82|0.289
73835718|NCT01243424|147220838|NON_INFERIORITY|This was the first step in a pre-defined hierarchical testing approach. The upper bound of the confidence interval (CI) of the Hazard ratio (HR) of linagliptin vs. glimepiride was compared with this noninferiority margin for the testing of non-inferiority. All non-inferiority tests were based on a margin of 1.3.|Hazard Ratio (HR)|0.98|||<|0.0001|TWO_SIDED|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test for non-inferiority were calculated.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride||||1.14|0.84|<0.0001
73835719|NCT01243424|147220838|SUPERIORITY|This was the second step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.98||||0.3813|TWO_SIDED|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.||||1.14|0.84|0.3813
73835720|NCT01243424|147220839|SUPERIORITY|This was the third step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.99||||0.4334|TWO_SIDED|95.47|0.86|1.14||P-values derived from Wald´s Chi-square test for non-inferiority.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.||||1.14|0.86|0.4334
73896806|NCT00955201|147326646|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
73896807|NCT00955201|147326646|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
73896808|NCT00955201|147326646|SUPERIORITY|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.72
73896809|NCT00955201|147326646|SUPERIORITY|||||||0.62|||||||ANOVA|||Comparison across groups at baseline.||||0.62
73835721|NCT01243424|147220840|OTHER||Odds Ratio (OR)|1.68|||<|0.0001|TWO_SIDED|95.47|1.43|1.96||p-value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.|||1.96|1.43|<0.0001
73896810|NCT00955201|147326646|SUPERIORITY|||||||0.33|||||||ANOVA|||Comparison across groups at 12 wks.||||0.33
73896811|NCT00955201|147326646|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.||||0.38
73896812|NCT00955201|147326647|SUPERIORITY|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.88
73896813|NCT00955201|147326647|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
73896814|NCT00955201|147326647|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
73835722|NCT01243424|147220841|OTHER||Odds Ratio (OR)|1.29||||0.0004|TWO_SIDED|95.47|1.11|1.48||p-value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.|This was the fifth step in a pre-defined hierarchical testing approach.||1.48|1.11|0.0004
73896815|NCT00955201|147326647|SUPERIORITY|||||||0.76||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.76
73896816|NCT00955201|147326647|SUPERIORITY|||||||0.82|||||||ANOVA|||Comparison across groups at baseline.||||0.82
73835723|NCT01243424|147220845|OTHER||Hazard Ratio (HR)|0.96||||0.5249|TWO_SIDED|95.0|0.85|1.09||p-value derived from Wald´s chi-square test.|Regression, Cox||Hazard ratio and confidence interval derived from Cox regression with factor treatment.|This was the fifth step in a pre-defined hierarchical testing approach.||1.09|0.85|0.5249
73896817|NCT00955201|147326647|SUPERIORITY|||||||0.53|||||||ANOVA|||Comparison across groups at 12 wks.||||0.53
73896818|NCT00955201|147326647|SUPERIORITY|||||||0.68|||||||ANOVA|||Comparison across groups at 24 wks.||||0.68
73896819|NCT00955201|147326648|SUPERIORITY|||||||0.7|||||||ANOVA|||Comparison across groups at baseline.||||0.70
73896820|NCT00955201|147326650|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.||||0.59
73896821|NCT00955201|147326651|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at baseline.||||0.45
73896822|NCT00955201|147326652|SUPERIORITY|||||||0.04|||||||ANOVA|||Comparison across groups at baseline.||||0.04
73835724|NCT01243424|147220846|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0023|TWO_SIDED|95.0|-0.15|-0.03|||ANCOVA|The Analysis of Covariance (ANCOVA) model includes the fixed categorical effect of treatment and the continuous covariate of baseline HbA1c.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||-0.03|-0.15|0.0023
73835725|NCT01243424|147220847|OTHER||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-9.7|-4.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||-4.8|-9.7|<0.0001
73835726|NCT01243424|147220848|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.64|TWO_SIDED|95.47|-1.3|2.1|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline LDL cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|LDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||2.1|-1.3|0.6400
73835727|NCT01243424|147220848|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0497|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline HDL cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|HDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||1.0|0.0|0.0497
73835728|NCT01243424|147220848|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.6823|TWO_SIDED|95.0|-2.4|1.6|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline total cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|Total cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||1.6|-2.4|0.6823
73835729|NCT01243424|147220849|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|3.1||0.2678|TWO_SIDED|95.0|-9.6|2.7|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||2.7|-9.6|0.2678
73835730|NCT01243424|147220850|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.5165|TWO_SIDED|95.0|-0.03|0.01|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline creatinine.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||0.01|-0.03|0.5165
73835731|NCT01243424|147220851|OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.4||0.5165|TWO_SIDED|95.0|0.2|1.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline eGFR.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||1.8|0.2|0.5165
73835732|NCT01243424|147220852|OTHER||geometric mean (gMean) ratio (%)|0.97||||0.2921|TWO_SIDED|95.0|0.91|1.03|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline UACR.|gMean ration= Linagliptin mean/ Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||1.03|0.91|0.2921
73835733|NCT01243424|147220854|EQUIVALENCE|This was the fifth step in a pre-defined hierarchical testing approach.|Mean Difference (Net)|4.13||||0.8402|TWO_SIDED|95.0|-36.46|44.71|||ANCOVA|The ANCOVA model includes the fixed categorical effects of treatment and the continuous covariate of baseline ISR.|Mean difference= Linagliptin mean- Glimepiride mean|||44.71|-36.46|0.8402
73835734|NCT01243424|147220855|OTHER||Odds Ratio (OR)|1.01||||0.9112|TWO_SIDED|95.0|0.86|1.18|||Regression, Logistic|Logistic regression model with terms for treatment as a fixed effect with Wald confidence Interval was used.|Linagliptin vs. Glimepiride odds is presented.|This was the fifth step in a pre-defined hierarchical testing approach.||1.18|0.86|0.9112
73835735|NCT00710554|147220863|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.34||||0.139|TWO_SIDED|95.0|-0.79|0.11|||ANCOVA|||The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. Due to the low power of the test for interaction, the test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.||0.11|-0.79|0.139
73835736|NCT00710554|147220864|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.86||||0.198|TWO_SIDED|95.0|-7.22|1.5|||ANCOVA|||The change from baseline in mean Neuropathic Pain Scale score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||1.50|-7.22|0.198
73835737|NCT00710554|147220865|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.83||||0.007|TWO_SIDED|95.0|-1.43|-0.23|||ANCOVA|||The change from baseline score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||-0.23|-1.43|0.007
73835738|NCT00710554|147220866|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.08||||0.795|TWO_SIDED|95.0|-0.52|0.68|||ANCOVA|||The change in the dynamic allodynia pain score from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.||0.68|-0.52|0.795
73835739|NCT00710554|147220867|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.14||||0.233|TWO_SIDED|95.0|-0.37|0.09|||ANCOVA|||The change in the punctate allodynia pain threshold force from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.||0.09|-0.37|0.233
73896823|NCT00955201|147326653|SUPERIORITY|||||||0.77|||||||ANOVA|||Comparison across groups at baseline.||||0.77
73896824|NCT00955201|147326654|SUPERIORITY|||||||0.12|||||||ANOVA|||Comparison across groups at baseline.||||0.12
73835740|NCT00710554|147220868|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.762||||0.023|TWO_SIDED|95.0|1.08|2.88|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The initial model incorporated treatment and centre group as factors. The odds ratio together with its 95% CI and associated p-value are presented.||2.88|1.08|0.023
73835741|NCT00710554|147220869|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.25||||0.288|TWO_SIDED|95.0|-0.72|0.21|||ANCOVA|||The change from baseline in mean Brief Pain Inventory (short form) score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||0.21|-0.72|0.288
73835742|NCT00710554|147220870|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.01||||0.617|TWO_SIDED|95.0|-0.06|0.04|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.||0.04|-0.06|0.617
73835743|NCT00710554|147220871|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|2.459||0.76|TWO_SIDED|95.0|-5.6|4.09|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.||4.09|-5.60|0.76
73835744|NCT00710554|147220872|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.38||||0.112|TWO_SIDED|95.0|-0.85|0.09|||ANCOVA|||The model used for the analysis of the end of study value was an ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The null hypothesis was one of no difference between treatments.||0.09|-0.85|0.112
73835745|NCT01301001|147220881|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||||0.0|-0.7|0.07
73835746|NCT01301001|147220882|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.76|TWO_SIDED|95.0|-0.9|0.6|||Mixed Models Analysis|||||0.6|-0.9|0.76
73835747|NCT01301001|147220883|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.36|TWO_SIDED|95.0|-0.5|0.2|||Mixed Models Analysis|||||0.2|-0.5|0.36
73835748|NCT00976391|147220905|NON_INFERIORITY_OR_EQUIVALENCE|P-value from a one-sided t-test to test whether the difference of least square means (albiglutide - preprandial lispro insulin) is less than or equal to the pre-specified non-inferiority margin of 0.4%|Mean Difference (Net)|-0.16|||<|0.0001|TWO_SIDED|95.0|-0.32|0.0|||t-test, 1 sided|||||0.00|-0.32|<0.0001
73835749|NCT05156125|147220913|SUPERIORITY||Risk Difference (RD)|16.1||||0.0184|TWO_SIDED|95.0|2.58|29.05|||Cochran-Mantel-Haenszel|||At 13 weeks||29.05|2.58|0.0184
73835750|NCT05156125|147220913|SUPERIORITY||Risk Difference (RD)|13.1||||0.041|TWO_SIDED|95.0|-0.03|25.58|||Cochran-Mantel-Haenszel|||At 13 weeks||25.58|-0.03|0.0410
73835751|NCT05156125|147220914|SUPERIORITY||Risk Difference (RD)|20.6||||0.007|TWO_SIDED|95.0|5.73|34.42|||Cochran-Mantel-Haenszel|||At 13 weeks||34.42|5.73|0.0070
73835752|NCT05156125|147220914|SUPERIORITY||Risk Difference (RD)|17.3||||0.0162|TWO_SIDED|95.0|2.75|30.67|||Cochran-Mantel-Haenszel|||At Week 13||30.67|2.75|0.0162
73835753|NCT05156125|147220915|SUPERIORITY||Risk Difference (RD)|16.5||||0.0448|TWO_SIDED|95.0|0.65|31.37|||Cochran-Mantel-Haenszel|||||31.37|0.65|0.0448
73835754|NCT05156125|147220915|SUPERIORITY||Risk Difference (RD)|16.0||||0.0417|TWO_SIDED|95.0|0.23|30.58|||Cochran-Mantel-Haenszel|||At Week 13||30.58|0.23|0.0417
73835755|NCT05156125|147220916|SUPERIORITY||Risk Difference (RD)|11.5||||0.0499|TWO_SIDED|95.0|-0.99|23.38|||Cochran-Mantel-Haenszel|||||23.38|-0.99|0.0499
73835756|NCT05156125|147220916|SUPERIORITY||Risk Difference (RD)|21.4||||0.0011|TWO_SIDED|95.0|7.94|33.53|||Cochran-Mantel-Haenszel|||At Week 13||33.53|7.94|0.0011
73835757|NCT05156125|147220917|SUPERIORITY|||||||0.0072|||||||Cochran-Mantel-Haenszel|||At Week 13||||0.0072
73835758|NCT05156125|147220917|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||At Week 13||||<0.0001
73835759|NCT03203512|147220924|SUPERIORITY||||||<|0.001||||||Treatment effect: p\<0.001; period effect : p=0.552; treatment x period interaction: p=0.622|ANOVA|||Null hypothesis is that there was no difference in change of total EV numbers detected by NTA between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total EV numbers.||||<0.001
73835760|NCT03203512|147220925|SUPERIORITY||||||=|0.001||||||Treatment: p=0.001; period: p=0.646; treatment x period interaction: p=0.267|ANOVA|||Null hypothesis is that there was no difference in change of total PS+EV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total PS+EV numbers.||||=0.001
73835761|NCT03203512|147220926|SUPERIORITY||||||=|0.002||||||Treatment: p=0.002; period: p=0.350; treatment x period interaction: p=0.572|ANOVA|||Null hypothesis is that there was no difference in change of PDEV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on PDEV numbers.||||=0.002
73835762|NCT03203512|147220926|SUPERIORITY|Null hypothesis is that there was no difference in change of EDEV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EDEV numbers.|||||<|0.001||||||Treatment: p\<0.001; period: p=0.362; treatment x period interaction: p=0.225|ANOVA|||||||<0.001
73835763|NCT03203512|147220927|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.010; treatment x period: p=0.608|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting lag time for TF-dependent thrombin generation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
73835764|NCT03203512|147220928|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.073; treatment x period: p=0.667|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent thrombin peak concentration between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
73896825|NCT00955201|147326655|SUPERIORITY|||||||0.42|||||||ANOVA|||Comparison across groups at baseline.||||0.42
73835765|NCT03203512|147220929|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.138; treatment x period: p=0.872|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting the time to reach peak TF-dependent thrombin concentration between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
73835766|NCT03203512|147220930|SUPERIORITY||||||=|0.015||||||Treatment: p=0.015; period: p=0.059; treatment x period: p=0.220|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent velocity index between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||=0.015
73835767|NCT03203512|147220931|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.118; treatment x period: p=0.802|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent endogenous thrombin potential (ETP) between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
73835768|NCT03203512|147220932|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to ADP between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
73835769|NCT03203512|147220932|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to epinephrine between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
73835770|NCT03203512|147220932|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to TRAP-6 between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
73835771|NCT03203512|147220932|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to U46619 between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
73835772|NCT03203512|147220933|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to CRP-XL between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
73835773|NCT03203512|147220934|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affecting endpoint for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
73835774|NCT03203512|147220934|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affectingamximum for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
73835775|NCT03203512|147220935|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affecting area under curve for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
73835776|NCT03203512|147220936|SUPERIORITY||||||<|0.001||||||Treatment: \<0.001; period: p=0.978; treatment x period interaction: p=0.140|ANOVA|||Null hypothesis is that there was no difference in change of EPA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EPA in circulating EV total lipids.||||<0.001
73835777|NCT03203512|147220936|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.699; treatment x period interaction: p=0.114|ANOVA|||Null hypothesis is that there was no difference in change of DHA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DHA in circulating EV total lipids.||||<0.001
73835778|NCT03203512|147220936|SUPERIORITY||||||=|0.011||||||Treatment: p=0.011; period: p=0.381; treatment x period interaction: p=0.762|ANOVA|||Null hypothesis is that there was no difference in change of oleic acid in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on oleic acid in circulating EV total lipids.||||=0.011
73835779|NCT03203512|147220936|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.512; treatment x period interaction: p=0.812|ANOVA|||Null hypothesis is that there was no difference in change of AA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on AA in circulating EV total lipids.||||<0.001
73835780|NCT03203512|147220936|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.160; treatment x period interaction: p=0.132|ANOVA|||Null hypothesis is that there was no difference in change of total n-3 PUFA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-3 PUFA in circulating EV total lipids.||||<0.001
73835781|NCT03203512|147220936|SUPERIORITY||||||=|0.013||||||Treatment: p=0.013; period: p=0.500; treatment x period interaction: p=0.522|ANOVA|||Null hypothesis is that there was no difference in change of total MUFA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total MUFA in circulating EV total lipids.||||=0.013
73835782|NCT03203512|147220937|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.169; treatment x period interaction: p=0.629|ANOVA|||Null hypothesis is that there was no difference in change of EPA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EPA in plasma total phospholipids.||||<0.001
73835783|NCT03203512|147220937|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.262; treatment x period interaction: p=0.150|ANOVA|||Null hypothesis is that there was no difference in change of DHA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DHA in plasma total phospholipids.||||<0.001
73835784|NCT03203512|147220937|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.302; treatment x period interaction: p=0.385|ANOVA|||Null hypothesis is that there was no difference in change of DPA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DPA in plasma total phospholipids.||||<0.001
73835785|NCT03203512|147220937|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.793; treatment x period interaction: p=0.522|ANOVA|||Null hypothesis is that there was no difference in change of linoleic acid in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on linoleic acid in plasma total phospholipids.||||<0.001
73835786|NCT03203512|147220937|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.956; treatment x period interaction: p=0.238|ANOVA|||Null hypothesis is that there was no difference in change of dihomo-γ-linolenic acid (DGLA) in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DGLA in plasma total phospholipids.||||<0.001
73835787|NCT03203512|147220937|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.457; treatment x period interaction: p=0.613|ANOVA|||Null hypothesis is that there was no difference in change of AA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on AA in plasma total phospholipids.||||<0.001
73835788|NCT03203512|147220937|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.134; treatment x period interaction: p=0.260|ANOVA|||Null hypothesis is that there was no difference in change of total n-3 PUFA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-3 PUFA in plasma total phospholipids.||||<0.001
73835789|NCT03203512|147220937|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.917; treatment x period interaction: p=0.603|ANOVA|||Null hypothesis is that there was no difference in change of total n-6 PUFA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-6 PUFA in plasma total phospholipids.||||<0.001
73835790|NCT03203512|147220938|SUPERIORITY||||||=|0.016||||||Treatment: p=0.016; period: p=0.566; treatment x period interaction: p=0.659|ANOVA|||Null hypothesis is that there was no difference in change of plasma TAG between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TAG.||||=0.016
73835791|NCT03203512|147220938|SUPERIORITY||||||=|0.014||||||Treatment: p=0.014; period: p=0.842; treatment x period interaction: p=0.943|ANOVA|||Null hypothesis is that there was no difference in change of plasma LDL-C between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma LDL-C.||||=0.014
73835792|NCT03203512|147220938|SUPERIORITY||||||=|0.077||||||Treatment: p=0.077; period: p=0.921; treatment x period interaction: p=0.793|ANOVA|||Null hypothesis is that there was no difference in change of plasma TC between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TC.||||=0.077
73835793|NCT03203512|147220938|SUPERIORITY||||||=|0.379||||||Treatment: p=0.379; period: p=0.938; treatment x period interaction: p=0.341|ANOVA|||Null hypothesis is that there was no difference in change of plasma HDL-C between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma HDL-C.||||=0.379
73835794|NCT03203512|147220939|SUPERIORITY||||||=|0.285||||||Treatment: p=0.285; period: p=0.954; treatment x period interaction: p=0.528|ANOVA|||Null hypothesis is that there was no difference in change of plasma TC/HDL-C ratio between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TC/HDL-C ratio.||||=0.285
73835795|NCT03203512|147220940|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period effect: p=0.011; treatment x period interaction: p=0.033|ANOVA|||Null hypothesis is that there was no difference in change of SBP between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on SBP.||||<0.001
73835796|NCT03203512|147220940|SUPERIORITY||||||=|0.002||||||Treatment: p=0.002; period: p=0.952; treatment x period interaction: p=0.114|ANOVA|||Null hypothesis is that there was no difference in change of DBP between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DBP.||||=0.002
73835797|NCT01145222|147220946|SUPERIORITY|Overall comparison between remimazolam and midazolam||||||0.007|||||||Fisher Exact|||||||0.007
73835798|NCT00927186|147220949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The pre-specified significance level 0.05 was used.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835799|NCT00927186|147220950|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
73835800|NCT00927186|147220951|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835801|NCT00927186|147220951|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
73835802|NCT00927186|147220952|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835803|NCT00927186|147220952|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835804|NCT00927186|147220953|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
73835805|NCT00927186|147220953|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
73835806|NCT00927186|147220954|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835807|NCT00927186|147220954|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835808|NCT00927186|147220954|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
73835809|NCT00927186|147220954|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
73835810|NCT00927186|147220955|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835811|NCT00927186|147220955|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835812|NCT00927186|147220956|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
73835813|NCT00927186|147220956|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
73835814|NCT00927186|147220957|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835815|NCT00927186|147220957|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835816|NCT00927186|147220957|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
73835817|NCT00927186|147220957|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
73835818|NCT00927186|147220958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835819|NCT00927186|147220958|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835820|NCT00927186|147220959|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.020
73835821|NCT00927186|147220959|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.005
73835822|NCT00927186|147220960|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835823|NCT00927186|147220960|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835824|NCT00927186|147220960|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.039
73835825|NCT00927186|147220960|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.025
73835826|NCT00927186|147220961|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835827|NCT00927186|147220961|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835828|NCT00927186|147220962|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.050
73835829|NCT00927186|147220962|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.016
73835830|NCT00927186|147220963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835831|NCT00927186|147220963|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835832|NCT00927186|147220963|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
73835833|NCT00927186|147220963|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
73835834|NCT00927186|147220964|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835835|NCT00927186|147220964|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835836|NCT00927186|147220965|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.906
73835837|NCT00927186|147220965|SUPERIORITY_OR_OTHER|||||||0.159||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.159
73835838|NCT00927186|147220966|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.049
73835839|NCT00927186|147220966|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835840|NCT00927186|147220966|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.151
73835841|NCT00927186|147220966|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.196
73835842|NCT00927186|147220967|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.502
73835843|NCT00927186|147220967|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.597
73835844|NCT00927186|147220968|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.077
73835845|NCT00927186|147220968|SUPERIORITY_OR_OTHER|||||||0.358||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.358
73835846|NCT00927186|147220969|SUPERIORITY_OR_OTHER|||||||0.647||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.647
73835847|NCT00927186|147220969|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.120
73835848|NCT00927186|147220969|SUPERIORITY_OR_OTHER|||||||0.695||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.695
73835849|NCT00927186|147220969|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||1.00
73835850|NCT00927186|147220970|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835851|NCT00927186|147220970|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
73835852|NCT00927186|147220971|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||1.00
73835853|NCT00927186|147220971|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.198
73835854|NCT00927186|147220972|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.022
73835855|NCT00927186|147220972|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835856|NCT00927186|147220972|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.151
73835857|NCT00927186|147220972|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.139
73835858|NCT00927186|147220973|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.154
73835859|NCT00927186|147220973|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.052
73835860|NCT00927186|147220974|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.906
73835861|NCT00927186|147220974|SUPERIORITY_OR_OTHER|||||||0.159||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.159
73835862|NCT00927186|147220975|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.979
73835863|NCT00927186|147220975|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.002
73835864|NCT00927186|147220975|SUPERIORITY_OR_OTHER|||||||0.695||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.695
73835865|NCT00927186|147220975|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.853
73835866|NCT00927186|147220976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835867|NCT00927186|147220976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835868|NCT00927186|147220977|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)|||||||0.006
73835869|NCT00927186|147220977|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)|||||||0.001
73835870|NCT00927186|147220978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for sLS/BS at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835871|NCT00927186|147220978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for dLS/BS at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835872|NCT00927186|147220978|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for sLS/BS at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.004
73835873|NCT00927186|147220978|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for dLS/BS at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.006
73835874|NCT00927186|147220979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact|||||||<0.001
73835875|NCT00927186|147220980|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact|||||||0.033
73835876|NCT00927186|147220981|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 6 months."|Fisher Exact|||||||<0.001
73835877|NCT00927186|147220981|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 24 months."|Fisher Exact|||||||0.009
73835878|NCT00927186|147220982|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
73835879|NCT00927186|147220983|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.906
73835880|NCT00927186|147220984|SUPERIORITY_OR_OTHER|||||||0.536||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.536
73835881|NCT00927186|147220984|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.896
73835882|NCT00927186|147220985|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73835883|NCT00927186|147220986|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
73835884|NCT00927186|147220987|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73835885|NCT00927186|147220988|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.008
73835886|NCT00927186|147220989|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835887|NCT00927186|147220989|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.006
73835888|NCT00927186|147220990|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73835889|NCT00927186|147220991|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.079
73835890|NCT00927186|147220992|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
73835891|NCT00927186|147220992|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.039
73835892|NCT00927186|147220993|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.014
73835893|NCT00927186|147220994|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.079
73835894|NCT00927186|147220995|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.027
73835895|NCT00927186|147220995|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.268
73835896|NCT00927186|147220996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
73835897|NCT00927186|147220997|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.025
73835898|NCT00927186|147220998|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.012
73835899|NCT00927186|147220998|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.092
73835900|NCT00927186|147220999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
73835901|NCT00927186|147220999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
73835902|NCT00927186|147220999|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
73835903|NCT00927186|147221000|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73835904|NCT00927186|147221001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
73835905|NCT00927186|147221001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
73835906|NCT00927186|147221001|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
73835907|NCT00927186|147221002|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73835908|NCT00927186|147221003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
73835909|NCT00927186|147221003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
73835910|NCT00927186|147221003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
73835911|NCT00927186|147221004|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
73835912|NCT02933476|147221018|SUPERIORITY||||||>|0.05|||||||ANOVA|||We compared off therapy UPDRS III scores at baseline to one and four weeks after stimulation.||||>0.05
73835913|NCT02933476|147221019|SUPERIORITY|||||||0.008|||||||ANOVA|||||||0.008
73835914|NCT02933476|147221020|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
73835915|NCT00986583|147221051|SUPERIORITY_OR_OTHER||Ratio of medians|1.34||||0.018|TWO_SIDED|95.0|1.05|1.72||This is for the primary comparison at 20 minute|ANCOVA||Ratio of medians of myoglobin measured at 20 minute for statin users vs. non-statin users|||1.72|1.05|0.018
73835916|NCT03767894|147221083|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|1.36||||0.24|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|t-test, 2 sided|Adjustment for p-value is 2.||Baseline scores compared to Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device).||||0.24
73835917|NCT03767894|147221083|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|-1.72||||0.207|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|t-test, 2 sided|Adjustment for p-value is 2.||Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (ARAT performed assisted with the use of the MyHand device).||||0.207
73835918|NCT03767894|147221084|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|2.64||||0.026|TWO_SIDED|||||a priori threshold: p\<0.05|Paired sample T-test|2-tailed||Baseline scores compared to Post Unassisted condition (UEMF performed unassisted/without the use of the MyHand device).||||0.026
73835919|NCT03767894|147221086|OTHER|Descriptive analysis (paired Wilcoxon)|Mean Difference (Final Values)|-1.09||||0.442|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|Wilcoxon (Mann-Whitney)|Adjustment for p-value is 2.||Baseline scores compared to Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) of the impaired (hemiparetic) hand.||||0.442
73835920|NCT03767894|147221086|OTHER|Descriptive analysis (paired Wilcoxon)|Mean Difference (Final Values)|-1.0||||1|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|Wilcoxon (Mann-Whitney)|Adjustment for p-value is 2.||Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (BBT performed assisted with the use of the MyHand device).||||1.0
73835921|NCT02187055|147221173|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-7.73||||0.2101|TWO_SIDED|98.34|-16.29|0.83|||Normal approximation to proportions|Multiplicity-adjusted||||0.83|-16.29|0.2101
73835922|NCT02187055|147221173|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-5.5||||0.0512|TWO_SIDED|98.34|-13.98|2.98|||Normal approximation to proportions|Multiplicity-adjusted||||2.98|-13.98|0.0512
73896826|NCT00955201|147326656|SUPERIORITY|||||||0.79|||||||ANOVA|||Comparison across groups at baseline.||||0.79
73835923|NCT02187055|147221173|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|2.23|||<|0.0001|TWO_SIDED|98.34|-6.4|10.86|||Normal approximation to proportions|Multiplicity adjusted||||10.86|-6.40|<0.0001
73835924|NCT02187055|147221174|SUPERIORITY_OR_OTHER||LS mean difference|2.8|||||TWO_SIDED|95.0|1.23|4.41||||||||4.41|1.23|
73835925|NCT02187055|147221174|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|0.33|3.49||||||||3.49|0.33|
73835926|NCT02187055|147221174|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.51|0.68||||||||0.68|-2.51|
73835927|NCT02187055|147221175|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||||TWO_SIDED|95.0|1.08|4.18||||||||4.18|1.08|
73835928|NCT02187055|147221175|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|0.4|3.48||||||||3.48|0.40|
73835929|NCT02187055|147221175|SUPERIORITY_OR_OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-2.24|0.86||||||||0.86|-2.24|
73835930|NCT02187055|147221176|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.16|0.5||||||||0.50|0.16|
73835931|NCT02187055|147221176|SUPERIORITY_OR_OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|0.05|0.39||||||||0.39|0.05|
73835932|NCT02187055|147221176|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.28|0.06||||||||0.06|-0.28|
73835933|NCT02187055|147221177|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.15|0.51||||||||0.51|0.15|
73835934|NCT02187055|147221177|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.1|0.46||||||||0.46|0.10|
73835935|NCT02187055|147221177|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.23|0.13||||||||0.13|-0.23|
73835936|NCT02187055|147221178|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.21|||||TWO_SIDED|95.0|-4.99|2.56||||||||2.56|-4.99|
73835937|NCT02187055|147221178|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.78|||||TWO_SIDED|95.0|-5.59|2.04||||||||2.04|-5.59|
73835938|NCT02187055|147221178|SUPERIORITY_OR_OTHER||Difference in remission rate|-0.56|||||TWO_SIDED|95.0|-4.53|3.4||||||||3.40|-4.53|
73835939|NCT02187055|147221179|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.4|||||TWO_SIDED|95.0|-7.95|1.15||||||||1.15|-7.95|
73835940|NCT02187055|147221179|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.06|||||TWO_SIDED|95.0|-7.55|1.43||||||||1.43|-7.55|
73835941|NCT02187055|147221179|SUPERIORITY_OR_OTHER||Difference in remission rate|0.34|||||TWO_SIDED|95.0|-4.45|5.14||||||||5.14|-4.45|
73835942|NCT02187055|147221180|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.67|||||TWO_SIDED|95.0|-8.29|0.94||||||||0.94|-8.29|
73835943|NCT02187055|147221180|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.06|||||TWO_SIDED|95.0|-7.59|1.48||||||||1.48|-7.59|
73835944|NCT02187055|147221180|SUPERIORITY_OR_OTHER||Difference in remission rate|0.62|||||TWO_SIDED|95.0|-4.24|5.47||||||||5.47|-4.24|
73835945|NCT02187055|147221181|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.55|||||TWO_SIDED|95.0|-6.03|2.93||||||||2.93|-6.03|
73835946|NCT02187055|147221181|SUPERIORITY_OR_OTHER||Difference in remission rate|-2.02|||||TWO_SIDED|95.0|-6.51|2.47||||||||2.47|-6.51|
73835947|NCT02187055|147221181|SUPERIORITY_OR_OTHER||Difference in remission rate|-0.47|||||TWO_SIDED|95.0|-5.11|4.18||||||||4.18|-5.11|
73835948|NCT02187055|147221182|SUPERIORITY_OR_OTHER||Difference in remission rate|-9.49|||||TWO_SIDED|95.0|-15.68|-3.3||||||||-3.30|-15.68|
73835949|NCT02187055|147221182|SUPERIORITY_OR_OTHER||Difference in remission rate|-6.89|||||TWO_SIDED|95.0|-12.94|-0.83||||||||-0.83|-12.94|
73835950|NCT02187055|147221182|SUPERIORITY_OR_OTHER||Difference in remission rate|2.61|||||TWO_SIDED|95.0|-3.86|9.07||||||||9.07|-3.86|
73835951|NCT02187055|147221183|SUPERIORITY_OR_OTHER||Difference in response rate|-6.24|||||TWO_SIDED|95.0|-13.32|0.84||||||||0.84|-13.32|
73835952|NCT02187055|147221183|SUPERIORITY_OR_OTHER||Difference in response rate|-3.66|||||TWO_SIDED|95.0|-10.69|3.37||||||||3.37|-10.69|
73835953|NCT02187055|147221183|SUPERIORITY_OR_OTHER||Difference in response rate|2.58|||||TWO_SIDED|95.0|-4.51|9.68||||||||9.68|-4.51|
73835954|NCT02187055|147221184|SUPERIORITY_OR_OTHER||Difference in response rate|-6.22|||||TWO_SIDED|95.0|-13.29|0.85||||||||0.85|-13.29|
73835955|NCT02187055|147221184|SUPERIORITY_OR_OTHER||Difference in response rate|-3.93|||||TWO_SIDED|95.0|-10.94|3.09||||||||3.09|-10.94|
73835956|NCT02187055|147221184|SUPERIORITY_OR_OTHER||Difference in response rate|2.3|||||TWO_SIDED|95.0|-4.79|9.39||||||||9.39|-4.79|
73835957|NCT02187055|147221185|SUPERIORITY_OR_OTHER||Difference in response rate|-6.02|||||TWO_SIDED|95.0|-12.05|0.0||||||||0.00|-12.05|
73835958|NCT02187055|147221185|SUPERIORITY_OR_OTHER||Difference in response rate|-6.89|||||TWO_SIDED|95.0|-12.9|-0.87||||||||-0.87|-12.90|
73835959|NCT02187055|147221185|SUPERIORITY_OR_OTHER||Difference in response rate|-0.87|||||TWO_SIDED|95.0|-7.17|5.44||||||||5.44|-7.17|
73835960|NCT02187055|147221186|SUPERIORITY_OR_OTHER||Difference in response rate|-4.87|||||TWO_SIDED|95.0|-11.92|2.18||||||||2.18|-11.92|
73835961|NCT02187055|147221186|SUPERIORITY_OR_OTHER||Difference in response rate|-5.48|||||TWO_SIDED|95.0|-12.49|1.52||||||||1.52|-12.49|
73835962|NCT02187055|147221186|SUPERIORITY_OR_OTHER||Difference in rresponse rate|-0.61|||||TWO_SIDED|95.0|-7.7|6.47||||||||6.47|-7.70|
73835963|NCT02187055|147221187|SUPERIORITY_OR_OTHER||Difference in response rate|-8.29|||||TWO_SIDED|95.0|-14.84|-1.75||||||||-1.75|-14.84|
73835964|NCT02187055|147221187|SUPERIORITY_OR_OTHER||Difference in response rate|-6.14|||||TWO_SIDED|95.0|-12.72|0.44||||||||0.44|-12.72|
73835965|NCT02187055|147221187|SUPERIORITY_OR_OTHER||Difference in response rate|2.15|||||TWO_SIDED|95.0|-4.22|8.52||||||||8.52|-4.22|
73835966|NCT02187055|147221188|SUPERIORITY_OR_OTHER||Difference in response rate|-6.77|||||TWO_SIDED|95.0|-12.61|-0.93||||||||-0.93|-12.61|
73835967|NCT02187055|147221188|SUPERIORITY_OR_OTHER||Difference in response rate|-2.5|||||TWO_SIDED|95.0|-8.09|3.1||||||||3.10|-8.09|
73835968|NCT02187055|147221188|SUPERIORITY_OR_OTHER||Difference in response rate|4.27|||||TWO_SIDED|95.0|-1.68|10.23||||||||10.23|-1.68|
73835969|NCT02187055|147221189|SUPERIORITY_OR_OTHER||LS mean difference|0.07|||||TWO_SIDED|95.0|-0.011|0.148||||||||0.148|-0.011|
73835970|NCT02187055|147221189|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.054|0.105||||||||0.105|-0.054|
73835971|NCT02187055|147221189|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|||||TWO_SIDED|95.0|-0.122|0.037||||||||0.037|-0.122|
73835972|NCT02187055|147221190|SUPERIORITY_OR_OTHER||Difference in response rate|-4.07|||||TWO_SIDED|95.0|-10.68|2.55||||||||2.55|-10.68|
73835973|NCT02187055|147221190|SUPERIORITY_OR_OTHER||Difference in response rate|-1.21|||||TWO_SIDED|95.0|-7.87|5.44||||||||5.44|-7.87|
73835974|NCT02187055|147221190|SUPERIORITY_OR_OTHER||Difference in response rate|2.86|||||TWO_SIDED|95.0|-3.72|9.43||||||||9.43|-3.72|
73835975|NCT02187055|147221191|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|||||TWO_SIDED|95.0|-2.28|-0.11||||||||-0.11|-2.28|
73835976|NCT02187055|147221191|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-2.16|0.01||||||||0.01|-2.16|
73835977|NCT02187055|147221191|SUPERIORITY_OR_OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.97|1.2||||||||1.20|-0.97|
73835978|NCT02187055|147221192|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.74|0.85||||||||0.85|-1.74|
73835979|NCT02187055|147221192|SUPERIORITY_OR_OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.48|2.11||||||||2.11|-0.48|
73835980|NCT02187055|147221192|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||||TWO_SIDED|95.0|-0.04|2.56||||||||2.56|-0.04|
73835981|NCT02187055|147221193|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.22|0.39||||||||0.39|-2.22|
73835982|NCT02187055|147221193|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.19|0.42||||||||0.42|-2.19|
73835983|NCT02187055|147221193|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-1.27|1.34||||||||1.34|-1.27|
73835984|NCT02187055|147221194|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-1.52|0.87||||||||0.87|-1.52|
73835985|NCT02187055|147221194|SUPERIORITY_OR_OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.8|1.58||||||||1.58|-0.80|
73835986|NCT02187055|147221194|SUPERIORITY_OR_OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.47|1.91||||||||1.91|-0.47|
73835987|NCT02187055|147221195|SUPERIORITY_OR_OTHER||LS mean difference|-2.0|||||TWO_SIDED|95.0|-3.25|-0.8||||||||-0.80|-3.25|
73835988|NCT02187055|147221195|SUPERIORITY_OR_OTHER||LS mean difference|-1.7|||||TWO_SIDED|95.0|-2.91|-0.47||||||||-0.47|-2.91|
73835989|NCT02187055|147221195|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-0.89|1.55||||||||1.55|-0.89|
73835990|NCT02187055|147221196|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|||||TWO_SIDED|95.0|-2.27|-0.05||||||||-0.05|-2.27|
73835991|NCT02187055|147221196|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-1.4|0.82||||||||0.82|-1.40|
73835992|NCT02187055|147221196|SUPERIORITY_OR_OTHER||LS mean difference|0.9|||||TWO_SIDED|95.0|-0.25|1.98||||||||1.98|-0.25|
73835993|NCT02187055|147221197|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|||||TWO_SIDED|95.0|-1.71|0.68||||||||0.68|-1.71|
73835994|NCT02187055|147221197|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-1.33|1.05||||||||1.05|-1.33|
73835995|NCT02187055|147221197|SUPERIORITY_OR_OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.83|1.57||||||||1.57|-0.83|
73835996|NCT02187055|147221198|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.2|0.45||||||||0.45|-2.20|
73835997|NCT02187055|147221198|SUPERIORITY_OR_OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-1.13|1.51||||||||1.51|-1.13|
73835998|NCT02187055|147221198|SUPERIORITY_OR_OTHER||LS mean difference|1.1|||||TWO_SIDED|95.0|-0.26|2.39||||||||2.39|-0.26|
73835999|NCT02187055|147221199|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-2.54|0.39||||||||0.39|-2.54|
73836000|NCT02187055|147221199|SUPERIORITY_OR_OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.76|2.16||||||||2.16|-0.76|
73836001|NCT02187055|147221199|SUPERIORITY_OR_OTHER||LS mean difference|1.8|||||TWO_SIDED|95.0|0.3|3.24||||||||3.24|0.30|
73836002|NCT02187055|147221200|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-1.55|1.08||||||||1.08|-1.55|
73836003|NCT02187055|147221200|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-1.01|1.62||||||||1.62|-1.01|
73836004|NCT02187055|147221200|SUPERIORITY_OR_OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-0.78|1.86||||||||1.86|-0.78|
73836005|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|||||TWO_SIDED|95.0|-2.279|1.427||||||Work hours missed due to problems||1.427|-2.279|
73836006|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-0.87|||||TWO_SIDED|95.0|-2.783|1.044||||||Work hours missed due to problems||1.044|-2.783|
73836007|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|||||TWO_SIDED|95.0|-2.349|1.462||||||Work hours missed due to problems||1.462|-2.349|
73836008|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|||||TWO_SIDED|95.0|-2.928|2.346||||||Work hours missed other reason||2.346|-2.928|
73836009|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|0.9|||||TWO_SIDED|95.0|-1.832|3.64||||||Work hours missed other reason||3.640|-1.832|
73836010|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||||TWO_SIDED|95.0|-1.52|3.911||||||Work hours missed other reason||3.911|-1.520|
73836011|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|4.95|||||TWO_SIDED|95.0|0.52|9.37||||||Hours worked in past 7 days||9.370|0.520|
73836012|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|2.85|||||TWO_SIDED|90.0|-1.736|7.43||||||Hours worked in past 7 days||7.430|-1.736|
73836013|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-2.1|||||TWO_SIDED|95.0|-6.65|2.454||||||Hours worked in past 7 days||2.454|-6.650|
73836014|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|0.21|||||TWO_SIDED|95.0|-0.373|0.786||||||Problems affecting productivity||0.786|-0.373|
73836015|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.578|0.607||||||Problems affecting productivity||0.607|-0.578|
73836016|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-0.19|||||TWO_SIDED|95.0|-0.784|0.4||||||Problems affecting productivity||0.400|-0.784|
73836017|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|0.24|||||TWO_SIDED|95.0|-0.112|0.587||||||Problem affecting daily activities||0.587|-0.112|
73836018|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.341|0.357||||||Problem affecting daily activities||0.357|-0.341|
73836019|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|||||TWO_SIDED|95.0|-0.582|0.122||||||Problem affecting daily activities||0.122|-0.582|
73836020|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-5.748|3.553||||||% work time missed due to health||3.553|-5.748|
73836021|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-2.64|||||TWO_SIDED|95.0|-7.339|2.067||||||% work time missed due to health||2.067|-7.339|
73836022|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-1.54|||||TWO_SIDED|95.0|-6.283|3.207||||||% work time missed due to health||3.207|-6.283|
73836023|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|2.07|||||TWO_SIDED|95.0|-3.726|7.858||||||% impairment while working due to health||7.858|-3.726|
73836024|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|0.15|||||TWO_SIDED|95.0|-5.777|6.068||||||% impairment while working due to health||6.068|-5.777|
73836025|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-1.92|||||TWO_SIDED|95.0|-7.839|3.998||||||% impairment while working due to health||3.998|-7.839|
73836026|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|2.11|||||TWO_SIDED|95.0|-4.664|8.877||||||% overall work impairment due to health||8.877|-4.664|
73836027|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|1.71|||||TWO_SIDED|95.0|-5.164|8.58||||||% overall work impairment due to health||8.580|-5.164|
73836028|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-7.307|6.51||||||% overall work impairment due to health||6.510|-7.307|
73836029|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||||TWO_SIDED|95.0|-1.118|5.873||||||% activity impairment due to health||5.873|-1.118|
73836030|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|0.08|||||TWO_SIDED|95.0|-3.411|3.573||||||% activity impairment due to health||3.573|-3.411|
73836031|NCT02187055|147221201|SUPERIORITY_OR_OTHER||LS mean difference|-2.3|||||TWO_SIDED|95.0|-5.818|1.225||||||% activity impairment due to health||1.225|-5.818|
73836032|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.057|0.011||||||Utility score||0.011|-0.057|
73836033|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.054|0.013||||||Utility score||0.013|-0.054|
73836034|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.031|0.036||||||Utility score||0.036|-0.031|
73836035|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|||||TWO_SIDED|95.0|-0.098|0.042||||||Mobility score||0.042|-0.098|
73836036|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-0.079|0.06||||||Mobility score||0.060|-0.079|
73836037|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.02|||||TWO_SIDED|95.0|-0.051|0.089||||||Mobility score||0.089|-0.051|
73836038|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.06|||||TWO_SIDED|95.0|-0.014|0.127||||||Self-care score||0.127|-0.014|
73836039|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-0.027|0.114||||||Self-care score||0.114|-0.027|
73836040|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-0.083|0.058||||||Self-care score||0.058|-0.083|
73836041|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.062|0.084||||||Usual activities score||0.084|-0.062|
73836042|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.06|||||TWO_SIDED|95.0|-0.018|0.129||||||Usual activities score||0.129|-0.018|
73836043|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-0.029|0.118||||||Usual activities score||0.118|-0.029|
73836044|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.041|0.091||||||Pain/discomfort score||0.091|-0.041|
73836045|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.05|||||TWO_SIDED|95.0|-0.015|0.116||||||Pain/discomfort score||0.116|-0.015|
73836046|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.041|0.091||||||Pain/discomfort score||0.091|-0.041|
73836047|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.046|0.103||||||Anxiety/depression score||0.103|-0.046|
73836048|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.066|0.083||||||Anxiety/depression score||0.083|-0.066|
73836049|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.094|0.055||||||Anxiety/depression score||0.055|-0.094|
73836050|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|-0.14|||||TWO_SIDED|95.0|-2.934|2.648||||||VAS score||2.648|-2.934|
73836051|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|1.23|||||TWO_SIDED|95.0|-1.556|4.016||||||VAS score||4.016|-1.556|
73836052|NCT02187055|147221202|SUPERIORITY_OR_OTHER||LS mean difference|1.37|||||TWO_SIDED|95.0|-1.425|4.171||||||VAS score||4.171|-1.425|
73836053|NCT02187055|147221203|SUPERIORITY_OR_OTHER||LS mean difference|-0.45|||||TWO_SIDED|95.0|-1.706|0.808||||||||0.808|-1.706|
73836054|NCT02187055|147221203|SUPERIORITY_OR_OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-0.178|2.325||||||||2.325|-0.178|
73836055|NCT02187055|147221203|SUPERIORITY_OR_OTHER||LS mean difference|1.52|||||TWO_SIDED|95.0|0.266|2.779||||||||2.779|0.266|
73836056|NCT00165698|147221237|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Symbols rank sum test|||||||0.26
73836057|NCT00165698|147221238|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Symbols rank sum test|||||||0.19
73836058|NCT00165698|147221239|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Symbols rank sum test|||||||0.31
73836059|NCT00165698|147221240|SUPERIORITY_OR_OTHER|||||||0.869||95.0|||||symbols rank sum test|||||||0.869
73836060|NCT00165698|147221241|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||symbols rank sum test|||||||0.174
73836061|NCT00165698|147221242|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
73836062|NCT00165698|147221243|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
73836063|NCT00165698|147221244|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
73836064|NCT02547935|147221247|SUPERIORITY||Difference in adjusted mean change|-0.58|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.8|-0.37||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||-0.37|-0.80|<0.001
73836065|NCT02547935|147221248|SUPERIORITY||Difference in adjusted mean change|-38.0|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|-48.2|-25.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.||-25.8|-48.2|<0.001
73836066|NCT02547935|147221248|SUPERIORITY||Difference in adjusted mean change|-21.0|STANDARD_ERROR_OF_MEAN|7.3||0.011|TWO_SIDED|95.0|-34.1|-5.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.||-5.2|-34.1|0.011
73836067|NCT02547935|147221249|SUPERIORITY||Difference in adjusted mean change|-0.04|STANDARD_ERROR_OF_MEAN|0.66||0.953|TWO_SIDED|95.0|-1.32|1.26||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.||1.26|-1.32|0.953
73836068|NCT02547935|147221249|SUPERIORITY||Difference in adjusted mean change|-0.87|STANDARD_ERROR_OF_MEAN|0.66||0.193|TWO_SIDED|95.0|-2.17|0.44||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.||0.44|-2.17|0.193
73836069|NCT02547935|147221250|SUPERIORITY||Difference in adjusted mean change|-6.1|STANDARD_ERROR_OF_MEAN|5.8||0.298|TWO_SIDED|95.0|-17.5|5.4||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||5.4|-17.5|0.298
73836070|NCT02547935|147221250|SUPERIORITY||Difference in adjusted mean change|-1.9|STANDARD_ERROR_OF_MEAN|5.9||0.746|TWO_SIDED|95.0|-13.6|9.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||9.8|-13.6|0.746
73836071|NCT02547935|147221251|SUPERIORITY||Odds Ratio (OR)|2.98|||<|0.001|TWO_SIDED|95.0|1.8|4.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.||4.8|1.8|<0.001
73836072|NCT02547935|147221251|SUPERIORITY||Odds Ratio (OR)|1.86||||0.013|TWO_SIDED|95.0|1.1|3.0||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.||3.0|1.1|0.013
73836073|NCT02547935|147221252|SUPERIORITY||Odds Ratio (OR)|5.43|||<|0.001|TWO_SIDED|95.0|2.6|11.2||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.||11.2|2.6|<0.001
73836074|NCT02547935|147221252|SUPERIORITY||Odds Ratio (OR)|1.74||||0.167|TWO_SIDED|95.0|0.8|3.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.||3.8|0.8|0.167
73836075|NCT02547935|147221253|SUPERIORITY||Difference in adjusted mean change|-4.8|STANDARD_ERROR_OF_MEAN|1.8||0.009|TWO_SIDED|95.0|-8.3|-1.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.||-1.2|-8.3|0.009
73836076|NCT02547935|147221253|SUPERIORITY||Difference in adjusted mean change|-2.8|STANDARD_ERROR_OF_MEAN|1.8||0.122|TWO_SIDED|95.0|-6.4|0.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.||0.8|-6.4|0.122
73836077|NCT02547935|147221254|SUPERIORITY||Difference in adjusted mean change|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.142|TWO_SIDED|95.0|-0.38|0.05||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||0.05|-0.38|0.142
73836078|NCT03461861|147221255|SUPERIORITY||Median Difference (Final Values)|-0.083|STANDARD_DEVIATION|0.0056||0.007567|TWO_SIDED|95.0|-0.0886|-0.0774|||t-test, 2 sided|||The null hypothesis (H0) of this superiority trials asserts that there is no true difference in functional connectivity between the interventions of placebo and AGB101, and the alternative hypothesis (H1) states that there is a difference between the interventions of placebo and AGB101. A type I error is the error of rejecting H0 when it is actually true.||-0.0774|-0.0886|0.007567
73836079|NCT03461861|147221256|SUPERIORITY||Mean Difference (Final Values)|3.12|STANDARD_DEVIATION|1.4||0.900593|TWO_SIDED|95.0|1.72|4.52|||t-test, 2 sided|||The null hypothesis (H0) of this trial asserts that there is no true difference in AVLT between the interventions of placebo and AGB101, and the alternative hypothesis (H1) states that there is a difference between the interventions of placebo and AGB101. A type I error is the error of rejecting H0 when it is actually true.||4.52|1.72|0.900593
73896827|NCT03595618|147326727|SUPERIORITY||Adjusted mean difference|0.04514|STANDARD_ERROR_OF_MEAN|0.02465||0.165|TWO_SIDED|95.0|-0.00317|0.09345||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using mixed-effects model for repeated measures (MMRM) including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value||0.09345|-0.00317|0.165
73896828|NCT03595618|147326727|SUPERIORITY||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.02585||0.939|TWO_SIDED|95.0|-0.03868|0.06267||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.06267|-0.03868|0.939
73896829|NCT03595618|147326727|SUPERIORITY||Adjusted mean difference|0.02329|STANDARD_ERROR_OF_MEAN|0.02536||0.682|TWO_SIDED|95.0|-0.02641|0.073|||Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.07300|-0.02641|0.682
73896830|NCT03595618|147326728|SUPERIORITY||Odds Ratio (OR)|1.47|STANDARD_ERROR_OF_MEAN|0.29||0.396|TWO_SIDED|95.0|0.84|2.58||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||2.58|0.84|0.396
73896831|NCT03595618|147326728|SUPERIORITY||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.26||0.951|TWO_SIDED|95.0|0.53|1.5||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||1.50|0.53|0.951
73896832|NCT03595618|147326728|SUPERIORITY||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.27||0.985|TWO_SIDED|95.0|0.64|1.83||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||1.83|0.64|0.985
73896833|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.7||0.467|TWO_SIDED|95.0|-5.6|1.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.3|-5.6|0.467
73896834|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.8||0.557|TWO_SIDED|95.0|-5.4|1.5||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.5|-5.4|0.557
73896835|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.8||0.593|TWO_SIDED|95.0|-5.3|1.6||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.6|-5.3|0.593
73896836|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.776|TWO_SIDED|95.0|-1.0|0.4||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.4|-1.0|0.776
73896837|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.446|TWO_SIDED|95.0|-1.2|0.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.3|-1.2|0.446
73896838|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.649|TWO_SIDED|95.0|-1.1|0.4||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.4|-1.1|0.649
73896839|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.3||0.452|TWO_SIDED|95.0|-4.1|0.9||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.9|-4.1|0.452
73896840|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.3||0.665|TWO_SIDED|95.0|-3.7|1.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.3|-3.7|0.665
73896841|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.3||0.598|TWO_SIDED|95.0|-3.9|1.2||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.2|-3.9|0.598
73896842|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4|TWO_SIDED|95.0|-0.6|0.1||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.1|-0.6|0.400
73896843|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.393|TWO_SIDED|95.0|-0.6|0.1||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.1|-0.6|0.393
73896844|NCT03595618|147326729|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.858|TWO_SIDED|95.0|-0.5|0.2||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.2|-0.5|0.858
73896845|NCT03595618|147326730|SUPERIORITY||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.5||0.705|TWO_SIDED|95.0|-7.1|2.7||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||2.7|-7.1|0.705
73896846|NCT03595618|147326730|SUPERIORITY||Adjusted mean difference|-4.1|STANDARD_ERROR_OF_MEAN|2.5||0.243|TWO_SIDED|95.0|-9.0|0.8||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.8|-9.0|0.243
73896847|NCT03595618|147326730|SUPERIORITY||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|2.5||0.949|TWO_SIDED|95.0|-6.1|3.9||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||3.9|-6.1|0.949
73896848|NCT03595618|147326731|SUPERIORITY||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|2.5||0.89|TWO_SIDED|95.0|-3.4|6.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||6.3|-3.4|0.890
73896849|NCT03595618|147326731|SUPERIORITY||Adjusted mean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.5||0.682|TWO_SIDED|95.0|-7.1|2.6||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||2.6|-7.1|0.682
73896850|NCT03595618|147326731|SUPERIORITY||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.5||1|TWO_SIDED|95.0|-4.8|5.0||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||5.0|-4.8|1.000
73896851|NCT03595618|147326732|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.21||0.991|TWO_SIDED|95.0|0.7|1.58||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.58|0.70|0.991
73896852|NCT03595618|147326732|SUPERIORITY||Odds Ratio (OR)|0.95|STANDARD_ERROR_OF_MEAN|0.21||0.992|TWO_SIDED|95.0|0.64|1.43||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.43|0.64|0.992
73896853|NCT03595618|147326732|SUPERIORITY||Odds Ratio (OR)|0.82|STANDARD_ERROR_OF_MEAN|0.21||0.653|TWO_SIDED|95.0|0.55|1.23||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.23|0.55|0.653
73896854|NCT03595618|147326733|SUPERIORITY||Adjusted mean difference|0.03779|STANDARD_ERROR_OF_MEAN|0.02156||0.193|TWO_SIDED|95.0|-0.00448|0.08005||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.08005|-0.00448|0.193
73896855|NCT03595618|147326733|SUPERIORITY||Adjusted mean difference|0.0358|STANDARD_ERROR_OF_MEAN|0.02235||0.256|TWO_SIDED|95.0|-0.00801|0.07962||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.07962|-0.00801|0.256
73896856|NCT03595618|147326733|SUPERIORITY||Adjusted mean difference|0.03884|STANDARD_ERROR_OF_MEAN|0.02243||0.201|TWO_SIDED|95.0|-0.00514|0.08281||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.08281|-0.00514|0.201
73896857|NCT03595618|147326734|SUPERIORITY||Adjusted mean difference|3.12394|STANDARD_ERROR_OF_MEAN|3.13671||0.627|TWO_SIDED|95.0|-3.02464|9.27252||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an analysis of covariance (ANCOVA) including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||9.27252|-3.02464|0.627
73896858|NCT03595618|147326734|SUPERIORITY||Adjusted mean difference|0.46842|STANDARD_ERROR_OF_MEAN|3.21111||0.998|TWO_SIDED|95.0|-5.82659|6.76343||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||6.76343|-5.82659|0.998
73896859|NCT03595618|147326734|SUPERIORITY||Adjusted mean difference|4.11756|STANDARD_ERROR_OF_MEAN|3.2759||0.449|TWO_SIDED|95.0|-2.30536|10.54049||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||10.54049|-2.30536|0.449
73896860|NCT03595618|147326735|SUPERIORITY||Adjusted mean difference|2.84781|STANDARD_ERROR_OF_MEAN|3.75674||0.789|TWO_SIDED|95.0|-4.51643|10.21205||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||10.21205|-4.51643|0.789
73896861|NCT03595618|147326735|SUPERIORITY||Adjusted mean difference|-3.64759|STANDARD_ERROR_OF_MEAN|3.84747||0.661|TWO_SIDED|95.0|-11.19071|3.89553||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||3.89553|-11.19071|0.661
73896862|NCT03595618|147326735|SUPERIORITY||Adjusted mean difference|-2.55176|STANDARD_ERROR_OF_MEAN|3.81987||0.843|TWO_SIDED|95.0|-10.04053|4.93701||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||4.93701|-10.04053|0.843
73896863|NCT03595618|147326736|SUPERIORITY||Adjusted mean difference|0.0951|STANDARD_ERROR_OF_MEAN|0.0499||0.141|TWO_SIDED|95.0|-0.0028|0.1929||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1929|-0.0028|0.141
73896864|NCT03595618|147326736|SUPERIORITY||Adjusted mean difference|0.0158|STANDARD_ERROR_OF_MEAN|0.0519||0.981|TWO_SIDED|95.0|-0.0861|0.1177||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1177|-0.0861|0.981
73896865|NCT03595618|147326736|SUPERIORITY||Adjusted mean difference|0.0753|STANDARD_ERROR_OF_MEAN|0.0529||0.349|TWO_SIDED|95.0|-0.0286|0.1792||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1792|-0.0286|0.349
73896866|NCT02279407|147326742|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.83||||0.046|TWO_SIDED|95.0|0.7|1.0||Hypotheses tested using Dunnett's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons versus a single control (placebo).|Mixed Models Analysis|||||1.00|0.70|0.046
73896867|NCT02279407|147326743|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.91||||0.502|TWO_SIDED|95.0|0.75|1.11||Conditional upon rejection of at least 1 of the 3 hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis|||||1.11|0.75|0.502
73896868|NCT02279407|147326743|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.91||||0.562|TWO_SIDED|95.0|0.73|1.13||Conditional upon rejection of at least 1 of the hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis|||||1.13|0.73|0.562
73896869|NCT00864916|147326747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.52|||||||Regression, Linear|||||||0.52
73896870|NCT03996369|147326748|SUPERIORITY||Risk Difference (RD)|9.69|||=|0.026|TWO_SIDED|95.0|1.14|18.23|||Cochran-Mantel-Haenszel|||Week 12||18.23|1.14|=0.026
73896871|NCT03996369|147326749|SUPERIORITY||Risk Difference (RD)|12.11|||=|0.009|TWO_SIDED|95.0|3.0|21.23|||Cochran-Mantel-Haenszel|||Week 12||21.23|3.00|=0.009
73896872|NCT03996369|147326750|SUPERIORITY||Risk Difference (RD)|17.48|||=|0.001|TWO_SIDED|95.0|6.81|28.15|||Cochran-Mantel-Haenszel|||Week 12||28.15|6.81|=0.001
73896873|NCT03996369|147326751|SUPERIORITY||Risk Difference (RD)|7.44|||=|0.036|TWO_SIDED|95.0|0.5|14.39|||Cochran-Mantel-Haenszel|||Week 12||14.39|0.50|=0.036
73896874|NCT03996369|147326752|SUPERIORITY||Risk Difference (RD)|21.23|||<|0.001|TWO_SIDED|95.0|10.18|32.29|||Cochran-Mantel-Haenszel|||Week 12||32.29|10.18|<0.001
73896875|NCT03996369|147326753|SUPERIORITY||Risk Difference (RD)|9.24|||=|0.009|TWO_SIDED|95.0|2.27|16.2|||Cochran-Mantel-Haenszel|||Week 12||16.20|2.27|=0.009
73896876|NCT03996369|147326754|SUPERIORITY||Risk Difference (RD)|5.85|||=|0.115|TWO_SIDED|95.0|-1.42|13.13|||Cochran-Mantel-Haenszel|||Week 2||13.13|-1.42|=0.115
73896877|NCT03996369|147326754|SUPERIORITY||Risk Difference (RD)|11.83|||=|0.007|TWO_SIDED|95.0|3.19|20.47|||Cochran-Mantel-Haenszel|||Week 4||20.47|3.19|=0.007
73896878|NCT03996369|147326754|SUPERIORITY||Risk Difference (RD)|14.84|||=|0.003|TWO_SIDED|95.0|4.98|24.69|||Cochran-Mantel-Haenszel|||Week 8||24.69|4.98|=0.003
73896879|NCT03996369|147326755|SUPERIORITY||Risk Difference (RD)|2.83|||=|0.128|TWO_SIDED|95.0|-0.81|6.48|||Cochran-Mantel-Haenszel|||Week 2||6.48|-0.81|=0.128
73896880|NCT03996369|147326755|SUPERIORITY||Risk Difference (RD)|8.32|||=|0.002|TWO_SIDED|95.0|3.01|13.64|||Cochran-Mantel-Haenszel|||Week 4||13.64|3.01|=0.002
73896881|NCT03996369|147326755|SUPERIORITY||Risk Difference (RD)|7.06|||=|0.032|TWO_SIDED|95.0|0.62|13.49|||Cochran-Mantel-Haenszel|||Week 8||13.49|0.62|=0.032
73896882|NCT03996369|147326755|SUPERIORITY||Risk Difference (RD)|9.18|||=|0.014|TWO_SIDED|95.0|1.82|16.54|||Cochran-Mantel-Haenszel|||Week 12||16.54|1.82|=0.014
73896883|NCT03996369|147326756|SUPERIORITY||Risk Difference (RD)|15.55|||=|0.002|TWO_SIDED|95.0|5.65|25.46|||Cochran-Mantel-Haenszel|||Week 2||25.46|5.65|=0.002
73896884|NCT03996369|147326756|SUPERIORITY||Risk Difference (RD)|14.98|||=|0.007|TWO_SIDED|95.0|4.05|25.91|||Cochran-Mantel-Haenszel|||Week 4||25.91|4.05|=0.007
73896885|NCT03996369|147326756|SUPERIORITY||Risk Difference (RD)|22.6|||<|0.001|TWO_SIDED|95.0|11.95|33.25|||Cochran-Mantel-Haenszel|||Week 8||33.25|11.95|<0.001
73896886|NCT03996369|147326756|SUPERIORITY||Risk Difference (RD)|17.58|||=|0.002|TWO_SIDED|95.0|6.7|28.47|||Cochran-Mantel-Haenszel|||Week 12||28.47|6.70|=0.002
73896887|NCT03996369|147326757|SUPERIORITY||Risk Difference (RD)|15.99|||=|0.002|TWO_SIDED|95.0|6.07|25.91|||Cochran-Mantel-Haenszel|||Week 2||25.91|6.07|=0.002
73896888|NCT03996369|147326757|SUPERIORITY||Risk Difference (RD)|15.45|||=|0.006|TWO_SIDED|95.0|4.54|26.36|||Cochran-Mantel-Haenszel|||Week 4||26.36|4.54|=0.006
73896889|NCT03996369|147326757|SUPERIORITY||Risk Difference (RD)|22.14|||<|0.001|TWO_SIDED|95.0|11.43|32.85|||Cochran-Mantel-Haenszel|||Week 8||32.85|11.43|<0.001
73896890|NCT03996369|147326757|SUPERIORITY||Risk Difference (RD)|18.49|||<|0.001|TWO_SIDED|95.0|7.65|29.33|||Cochran-Mantel-Haenszel|||Week 12||29.33|7.65|<0.001
73896891|NCT02683746|147326779|NON_INFERIORITY|The primary hypothesis tested was that the liquid drug product would provide glycemic control non-inferior to the lyophilized drug product for a period of 26 weeks of treatment in participants with T2DM. Non-inferiority testing was performed at a one-sided alpha of 0.025 and non-inferiority margin of 0.4.|Mean Difference (Net)|0.06||||0.0002|TWO_SIDED|95.0|-0.13|0.24||P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model|||||0.24|-0.13|0.0002
73896892|NCT02683746|147326787|OTHER||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.83|0.14||||||||0.14|-0.83|
73896893|NCT02683746|147326788|OTHER||Mean Difference (Net)|0.03|||<|0.0001|TWO_SIDED|95.0|-0.07|0.13||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 4 are presented.|||0.13|-0.07|<0.0001
73896894|NCT02683746|147326788|OTHER||Mean Difference (Net)|0.07|||<|0.0001|TWO_SIDED|95.0|-0.07|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 8 are presented.|||0.20|-0.07|<0.0001
73896895|NCT02683746|147326788|OTHER||Mean Difference (Net)|0.08|||<|0.0001|TWO_SIDED|95.0|-0.08|0.24||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 12 are presented.|||0.24|-0.08|<0.0001
73896896|NCT02683746|147326788|OTHER||Mean Difference (Net)|0.02|||<|0.0001|TWO_SIDED|95.0|-0.16|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 16 are presented.|||0.20|-0.16|<0.0001
73896897|NCT02683746|147326788|OTHER||Mean Difference (Net)|0.02|||<|0.0001|TWO_SIDED|95.0|-0.15|0.19||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 20 are presented.|||0.19|-0.15|<0.0001
73896898|NCT02683746|147326788|OTHER||Mean Difference (Net)|0.01|||<|0.0001|TWO_SIDED|95.0|-0.17|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 26 are presented.|||0.20|-0.17|<0.0001
73896899|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.15|0.65|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 1 are presented.|||0.65|-0.15|
73896900|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.2|0.69|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 2 are presented.|||0.69|-0.20|
73896901|NCT02683746|147326789|OTHER||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.42|0.4|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 3 are presented.|||0.40|-0.42|
73896902|NCT02683746|147326789|OTHER||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.42|0.36|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 4 are presented.|||0.36|-0.42|
73896903|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.19|||||TWO_SIDED|95.0|-0.19|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 5 are presented.|||0.57|-0.19|
73896904|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.26|0.55|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 6 are presented.|||0.55|-0.26|
73896905|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-0.16|0.71|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 7 are presented.|||0.71|-0.16|
73896906|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.19|||||TWO_SIDED|95.0|-0.22|0.6|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 8 are presented.|||0.60|-0.22|
73896907|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.41|0.47|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 9 are presented.|||0.47|-0.41|
73896908|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.28|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 10 are presented.|||0.57|-0.28|
73896909|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.34|0.56|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 11 are presented.|||0.56|-0.34|
73896910|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.41|0.46|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 12 are presented.|||0.46|-0.41|
73896911|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.47|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 13 are presented.|||0.57|-0.47|
73896912|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.41|0.54|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 16 are presented.|||0.54|-0.41|
73896913|NCT02683746|147326789|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.47|0.53|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 20 are presented.|||0.53|-0.47|
73896914|NCT02683746|147326789|OTHER||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.83|0.14|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 26 are presented.|||0.14|-0.83|
73896915|NCT04987944|147326791|OTHER||Least square mean difference|-9.8|||||TWO_SIDED|95.0|-24.5|5.0||||||||5.0|-24.5|
73896916|NCT04987944|147326792|OTHER||Least square mean difference|-3.9|||||TWO_SIDED|95.0|-19.4|11.5||||||||11.5|-19.4|
73896917|NCT04987944|147326793|OTHER||Least square mean difference|0.423|||||TWO_SIDED|95.0|-0.125|0.972||||||||0.972|-0.125|
73896918|NCT02614469|147326797|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|103.0|||||TWO_SIDED|90.0|98.0|108.0|||||Fed/Fasting Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||108|98.0|
73896919|NCT02614469|147326798|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|99.3|||||TWO_SIDED|90.0|96.9|102.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||102|96.9|
73896920|NCT02614469|147326802|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|103.0|||||TWO_SIDED|90.0|90.9|118.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||118|90.9|
73896921|NCT02614469|147326803|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|83.4|||||TWO_SIDED|90.0|62.1|112.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||112|62.1|
73896922|NCT00345332|147326809|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
73896923|NCT00345332|147326810|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
73896924|NCT02112045|147326833|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
73896925|NCT02112045|147326834|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
73896926|NCT00977080|147326837|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the IV stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.||||0.016
73896927|NCT00977080|147326837|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|95.0||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the oral stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.||||0.260
73896928|NCT00977080|147326838|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73896929|NCT00977080|147326838|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||Fisher Exact|||||||0.239
73896930|NCT00977080|147326839|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73896931|NCT00977080|147326839|SUPERIORITY_OR_OTHER|||||||0.704||95.0|||||Fisher Exact|||||||0.704
73896932|NCT00977080|147326840|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||||||0.010
73896933|NCT00977080|147326841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73896934|NCT00977080|147326841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
73896935|NCT00977080|147326842|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||Fisher Exact|||||||0.118
73896936|NCT00977080|147326842|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
73896937|NCT00441116|147326846|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.54|STANDARD_DEVIATION|20.37||0.0319||95.0|0.75|14.33|||t-test, 2 sided||Mean difference = Drug A minus Drug B|Month 6 - Baseline||14.33|0.75|0.0319
73896938|NCT03192358|147326878|SUPERIORITY||Cohen's d|1.18|||<|0.001|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05.|ANOVA||Cohen's d values \> 0.8 are considered large|This was an observational study. The statistical test explores whether there were significant differences in tongue pressure between the two cohorts. The hypothesis was that individuals with ALS would display significantly lower maximum anterior isometric tongue pressures compared to the people with PD.||||< 0.001
73896939|NCT03192358|147326879|SUPERIORITY||Cohen's d|1.75|||<|0.001|TWO_SIDED||||||ANOVA||Cohen's d values \> 0.8 are considered large|This was an observational study rather than a trial. The hypothesis was that individuals with ALS would display significantly lower regular effort saliva swallow pressures than the individuals with PD.||||< 0.001
73896940|NCT02509117|147326932|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-58.659|STANDARD_ERROR_OF_MEAN|0.0642|<|0.0001|TWO_SIDED|80.0|-61.95|-55.08|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-55.08|-61.95|<0.0001
73896941|NCT02509117|147326932|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-68.026|STANDARD_ERROR_OF_MEAN|0.0665|<|0.0001|TWO_SIDED|80.0|-70.66|-65.16|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-65.16|-70.66|<0.0001
73896942|NCT02509117|147326932|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.152|STANDARD_ERROR_OF_MEAN|0.0643|<|0.0001|TWO_SIDED|80.0|-87.26|-84.95|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-84.95|-87.26|<0.0001
73896943|NCT02509117|147326932|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.558|STANDARD_ERROR_OF_MEAN|0.0558|<|0.0001|TWO_SIDED|80.0|-44.7|-36.1|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-36.10|-44.70|<0.0001
73896944|NCT02509117|147326932|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.368|STANDARD_ERROR_OF_MEAN|0.0561|<|0.0001|TWO_SIDED|80.0|-54.78|-47.7|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-47.70|-54.78|<0.0001
73896945|NCT02509117|147326932|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.583|STANDARD_ERROR_OF_MEAN|0.0558|<|0.0001|TWO_SIDED|80.0|-62.4|-56.56|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-56.56|-62.40|<0.0001
73896946|NCT02509117|147326932|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.373|STANDARD_ERROR_OF_MEAN|0.1007|<|0.0001|TWO_SIDED|80.0|-45.06|-28.62|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-28.62|-45.06|<0.0001
73896947|NCT02509117|147326932|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.018|STANDARD_ERROR_OF_MEAN|0.1001|<|0.0001|TWO_SIDED|80.0|-51.72|-37.38|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-37.38|-51.72|<0.0001
73896948|NCT02509117|147326932|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.797|STANDARD_ERROR_OF_MEAN|0.1014|<|0.0001|TWO_SIDED|80.0|-66.51|-56.42|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-56.42|-66.51|<0.0001
73896949|NCT01332461|147326945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.649||||0.05|TWO_SIDED|95.0|0.455|0.926|||Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.926|0.455|0.05
73896950|NCT01332461|147326946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601|||<|0.05|TWO_SIDED|95.0|0.326|1.109||COPD-related hospitalization|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||1.109|0.326|<0.05
73896951|NCT01332461|147326946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.651|||<|0.05|TWO_SIDED|95.0|0.434|0.977||COPD-related ER visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.977|0.434|<0.05
73896952|NCT01332461|147326946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.815|||<|0.05|TWO_SIDED|95.0|0.658|1.008||COPD-related physician + Rx visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||1.008|0.658|<0.05
73896953|NCT01332461|147326946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.785|||<|0.05|TWO_SIDED|95.0|0.649|0.948||COPD-related hospitalization/ER visit/physician+Rx|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.948|0.649|<0.05
73896954|NCT04345367|147326991|SUPERIORITY||Estimate of difference|22.6|||<|0.0001|TWO_SIDED|95.0|15.8|29.5||Cochran-Mantel-Haenszel (CMH) method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.5|15.8|<0.0001
73896955|NCT04345367|147326992|SUPERIORITY||Estimate of difference|14.1|||<|0.0001|TWO_SIDED|95.0|8.2|20.0||CMH method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.0|8.2|<0.0001
73896956|NCT04345367|147326993|SUPERIORITY||Estimate of difference|12.5||||0.0008|TWO_SIDED|95.0|5.3|19.7||CMH method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||19.7|5.3|0.0008
73896957|NCT04345367|147326994|OTHER||Estimate of difference|4.5|||||TWO_SIDED|95.0|0.2|8.7|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||8.7|0.2|
73896958|NCT04345367|147326994|OTHER||Estimate of difference|20.0|||||TWO_SIDED|95.0|13.2|26.9|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.9|13.2|
73896959|NCT04345367|147326994|OTHER||Estimate of difference|14.0|||||TWO_SIDED|95.0|6.9|21.1|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||21.1|6.9|
73896960|NCT04345367|147326994|OTHER||Estimate of difference|12.7|||||TWO_SIDED|95.0|5.5|20.0|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.0|5.5|
73896961|NCT04345367|147326994|OTHER||Estimate of difference|6.9|||||TWO_SIDED|95.0|-0.4|14.3|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||14.3|-0.4|
73896962|NCT04345367|147326995|OTHER||Estimate of difference|8.1|||||TWO_SIDED|95.0|1.8|14.4|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||14.4|1.8|
73896963|NCT04345367|147326995|OTHER||Estimate of difference|20.9|||||TWO_SIDED|95.0|13.8|28.0|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.0|13.8|
73896964|NCT04345367|147326995|OTHER||Estimate of difference|18.4|||||TWO_SIDED|95.0|11.4|25.3|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||25.3|11.4|
73896965|NCT04345367|147326995|OTHER||Estimate of difference|14.9|||||TWO_SIDED|95.0|8.2|21.5|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||21.5|8.2|
73896966|NCT04345367|147326995|OTHER||Estimate of difference|9.5|||||TWO_SIDED|95.0|3.0|16.0|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.0|3.0|
73896967|NCT04345367|147326995|OTHER||Estimate of difference|5.0|||||TWO_SIDED|95.0|-1.4|11.5|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.5|-1.4|
73896968|NCT04345367|147326995|OTHER||Estimate of difference|0.7|||||TWO_SIDED|95.0|-5.9|7.2|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||7.2|-5.9|
73896969|NCT04345367|147326996|OTHER||Estimate of difference|7.3|||||TWO_SIDED|95.0|2.8|11.7|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.7|2.8|
73896970|NCT04345367|147326996|OTHER||Estimate of difference|20.6|||||TWO_SIDED|95.0|14.3|26.9|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.9|14.3|
73896971|NCT04345367|147326996|OTHER||Estimate of difference|19.5|||||TWO_SIDED|95.0|12.5|26.4|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.4|12.5|
73896972|NCT04345367|147326996|OTHER||Estimate of difference|15.8|||||TWO_SIDED|95.0|8.7|23.0|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||23.0|8.7|
73896973|NCT04345367|147326996|OTHER||Estimate of difference|13.0|||||TWO_SIDED|95.0|5.9|20.2|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.2|5.9|
73896974|NCT04345367|147326996|OTHER||Estimate of difference|9.2|||||TWO_SIDED|95.0|2.0|16.4|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.4|2.0|
73896975|NCT04345367|147326996|OTHER||Estimate of difference|4.5|||||TWO_SIDED|95.0|-2.8|11.8|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.8|-2.8|
73896976|NCT04345367|147326997|OTHER||Estimate of difference|7.1|||||TWO_SIDED|95.0|3.1|11.1|||||Day 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.1|3.1|
73896977|NCT04345367|147326997|OTHER||Estimate of difference|6.5|||||TWO_SIDED|95.0|1.7|11.3|||||Day 3. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.3|1.7|
73896978|NCT04345367|147326997|OTHER||Estimate of difference|11.4|||||TWO_SIDED|95.0|6.0|16.8|||||Day 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.8|6.0|
73896979|NCT04345367|147326997|OTHER||Estimate of difference|14.5|||||TWO_SIDED|95.0|8.8|20.3|||||Day 5. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.3|8.8|
73896980|NCT04345367|147326997|OTHER||Estimate of difference|12.9|||||TWO_SIDED|95.0|6.9|19.0|||||Day 6. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||19.0|6.9|
73896981|NCT04345367|147326997|OTHER||Estimate of difference|19.9|||||TWO_SIDED|95.0|13.8|26.0|||||Day 7. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.0|13.8|
73896982|NCT04345367|147326997|OTHER||Estimate of difference|22.1|||||TWO_SIDED|95.0|15.9|28.3|||||Day 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.3|15.9|
73896983|NCT04345367|147326997|OTHER||Estimate of difference|21.7|||||TWO_SIDED|95.0|15.2|28.1|||||Day 9. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.1|15.2|
73896984|NCT04345367|147326997|OTHER||Estimate of other|21.3|||||TWO_SIDED|95.0|14.7|27.9|||||Day 10. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||27.9|14.7|
73896985|NCT04345367|147326997|OTHER||Estimate of difference|20.0|||||TWO_SIDED|95.0|13.3|26.6|||||Day 11. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.6|13.3|
73896986|NCT04345367|147326997|OTHER||Estimate of difference|21.3|||||TWO_SIDED|95.0|14.6|27.9|||||Day 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||27.9|14.6|
73896987|NCT04345367|147326997|OTHER||Estimate of difference|22.5|||||TWO_SIDED|95.0|15.8|29.2|||||Day 13. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.2|15.8|
73896988|NCT04345367|147326997|OTHER||Estimate of difference|22.4|||||TWO_SIDED|95.0|15.6|29.2|||||Day 14. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.2|15.6|
73896989|NCT04345367|147326997|OTHER||Estimate of difference|22.9|||||TWO_SIDED|95.0|16.0|29.9|||||Day 15. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.9|16.0|
73896990|NCT04345367|147326998|OTHER||Estimate of difference|17.3|||||TWO_SIDED|95.0|10.1|24.5|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||24.5|10.1|
73896991|NCT04345367|147326998|OTHER||Estimate of difference|13.0|||||TWO_SIDED|95.0|6.0|20.1|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.1|6.0|
73896992|NCT04345367|147326998|OTHER||Estimate of difference|4.4|||||TWO_SIDED|95.0|-2.5|11.4|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.4|-2.5|
73896993|NCT04345367|147326998|OTHER||Estimate of difference|3.6|||||TWO_SIDED|95.0|-3.4|10.5|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||10.5|-3.4|
73896994|NCT04345367|147326998|OTHER||Estimate of difference|2.0|||||TWO_SIDED|95.0|-4.9|9.0|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||9.0|-4.9|
73896995|NCT04345367|147326998|OTHER||Estimate of difference|5.0|||||TWO_SIDED|95.0|-1.9|11.9|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.9|-1.9|
73896996|NCT04345367|147327000|OTHER||Least square mean difference|-9.3|||||TWO_SIDED|95.0|-14.0|-4.6|||||Week 2. Analysis was performed using Mixed Model Repeated Measure (MMRM) with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-4.6|-14.0|
73896997|NCT04345367|147327000|OTHER||Least square mean difference|-12.5|||||TWO_SIDED|95.0|-17.4|-7.6|||||Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-7.6|-17.4|
73896998|NCT04345367|147327000|OTHER||Least square mean difference|-11.1|||||TWO_SIDED|95.0|-15.6|-6.6|||||Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-6.6|-15.6|
73896999|NCT04345367|147327000|OTHER||Least square mean difference|-9.4|||||TWO_SIDED|95.0|-13.7|-5.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-5.1|-13.7|
73897000|NCT04345367|147327000|OTHER||Least square mean difference|-6.9|||||TWO_SIDED|95.0|-10.9|-2.9|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-2.9|-10.9|
73897001|NCT04345367|147327000|OTHER||Least square mean difference|-5.3|||||TWO_SIDED|95.0|-9.0|-1.7|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.7|-9.0|
73897002|NCT04345367|147327000|OTHER||Least square mean difference|-3.4|||||TWO_SIDED|95.0|-7.1|0.4|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-7.1|
73897003|NCT04345367|147327001|OTHER||Least square mean difference|-11.0|||||TWO_SIDED|95.0|-14.5|-7.6|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-7.6|-14.5|
73897004|NCT04345367|147327001|OTHER||Least square mean difference|-12.8|||||TWO_SIDED|95.0|-16.0|-9.5|||||Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-9.5|-16.0|
73897005|NCT04345367|147327001|OTHER||Least square mean difference|-10.2|||||TWO_SIDED|95.0|-13.6|-6.8|||||Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-6.8|-13.6|
73897006|NCT04345367|147327001|OTHER||Least square mean difference|-7.3|||||TWO_SIDED|95.0|-10.5|-4.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-4.1|-10.5|
73897007|NCT04345367|147327001|OTHER||Least square mean difference|-6.1|||||TWO_SIDED|95.0|-9.3|-3.0|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-3.0|-9.3|
73897008|NCT04345367|147327001|OTHER||Least square mean difference|-4.9|||||TWO_SIDED|95.0|-8.2|-1.7|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.7|-8.2|
73897009|NCT04345367|147327001|OTHER||Least square mean difference|-3.3|||||TWO_SIDED|95.0|-6.6|0.1|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-6.6|
73897010|NCT04345367|147327002|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.4|
73897011|NCT04345367|147327002|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-0.3|
73897012|NCT04345367|147327002|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.6|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.3|
73897013|NCT04345367|147327003|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.3|-0.3|
73897014|NCT04345367|147327003|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-0.2|
73897015|NCT04345367|147327003|OTHER||Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.1|
73897016|NCT04345367|147327004|OTHER||Least square mean difference|-2.0|||||TWO_SIDED|95.0|-2.6|-1.3|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.3|-2.6|
73897017|NCT04345367|147327004|OTHER||Least square mean difference|-1.0|||||TWO_SIDED|95.0|-1.6|-0.4|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.4|-1.6|
73897018|NCT04345367|147327004|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-1.4|-0.2|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.2|-1.4|
73897019|NCT04345367|147327004|OTHER||Least square mean difference|-0.6|||||TWO_SIDED|95.0|-1.2|0.0|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.0|-1.2|
73897020|NCT04345367|147327004|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-1.0|0.4|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-1.0|
73897021|NCT04345367|147327005|OTHER||Least square mean difference|0.818|||||TWO_SIDED|95.0|-1.22|2.856|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.856|-1.220|
73897022|NCT04345367|147327005|OTHER||Least square mean difference|2.093|||||TWO_SIDED|95.0|-0.081|4.267|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||4.267|-0.081|
73897023|NCT04345367|147327005|OTHER||Least square mean difference|-0.816|||||TWO_SIDED|95.0|-2.914|1.281|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.281|-2.914|
73897024|NCT04345367|147327006|OTHER||Least square mean difference|-1.6|||||TWO_SIDED|95.0|-2.5|-0.7|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.7|-2.5|
73897025|NCT04345367|147327006|OTHER||Least square mean difference|-1.4|||||TWO_SIDED|95.0|-2.2|-0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.5|-2.2|
73897026|NCT04345367|147327006|OTHER||Least square mean difference|-0.4|||||TWO_SIDED|95.0|-1.3|0.5|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-1.3|
73897027|NCT04345367|147327007|OTHER||Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6|||||Quantity of hours slept: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.1|
73897028|NCT04345367|147327007|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Quantity of hours slept: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.2|
73897029|NCT04345367|147327007|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Quantity of hours slept: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.2|
73897030|NCT04345367|147327007|OTHER||Least square mean difference|1.2|||||TWO_SIDED|95.0|-0.9|3.4|||||Short of Breath or Headache score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-0.9|
73897031|NCT04345367|147327007|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-2.0|2.2|||||Short of Breath or Headache score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.2|-2.0|
73897032|NCT04345367|147327007|OTHER||Least square mean difference|0.6|||||TWO_SIDED|95.0|-1.5|2.6|||||Short of Breath or Headache score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.6|-1.5|
73897033|NCT04345367|147327007|OTHER||Least square mean difference|-1.8|||||TWO_SIDED|95.0|-4.2|0.5|||||Snoring score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-4.2|
73897034|NCT04345367|147327007|OTHER||Least square mean difference|-0.9|||||TWO_SIDED|95.0|-3.3|1.5|||||Snoring score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.5|-3.3|
73897035|NCT04345367|147327007|OTHER||Least square mean difference|0.8|||||TWO_SIDED|95.0|-1.7|3.4|||||Snoring score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-1.7|
73897036|NCT04345367|147327007|OTHER||Least square mean difference|-4.1|||||TWO_SIDED|95.0|-6.6|-1.6|||||Sleep disturbance score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.6|-6.6|
73897037|NCT04345367|147327007|OTHER||Least square mean difference|-3.8|||||TWO_SIDED|95.0|-6.2|-1.4|||||Sleep disturbance score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.4|-6.2|
73897038|NCT04345367|147327007|OTHER||Least square mean difference|-1.7|||||TWO_SIDED|95.0|-4.1|0.7|||||Sleep disturbance score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.7|-4.1|
73897039|NCT04345367|147327007|OTHER||Least square mean difference|1.0|||||TWO_SIDED|95.0|-1.6|3.6|||||Sleep adequacy score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.6|-1.6|
73897040|NCT04345367|147327007|OTHER||Least square mean difference|2.9|||||TWO_SIDED|95.0|0.4|5.4|||||Sleep adequacy score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||5.4|0.4|
73897041|NCT04345367|147327007|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-1.9|3.4|||||Sleep adequacy score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-1.9|
73897042|NCT04345367|147327007|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-2.8|1.3|||||Sleep somnolence score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.3|-2.8|
73897043|NCT04345367|147327007|OTHER||Least square mean difference|-2.4|||||TWO_SIDED|95.0|-4.4|-0.4|||||Sleep somnolence score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.4|-4.4|
73897044|NCT04345367|147327007|OTHER||Least square mean difference|-2.3|||||TWO_SIDED|95.0|-4.3|-0.3|||||Sleep somnolence score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.3|-4.3|
73897045|NCT04345367|147327007|OTHER||Least square mean difference|-1.2|||||TWO_SIDED|95.0|-3.0|0.7|||||Sleep Problems Index I score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.7|-3.0|
73897046|NCT04345367|147327007|OTHER||Least square mean difference|-2.3|||||TWO_SIDED|95.0|-4.0|-0.5|||||Sleep Problems Index I score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.5|-4.0|
73897047|NCT04345367|147327007|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-2.5|0.9|||||Sleep Problems Index I score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.9|-2.5|
73897048|NCT04345367|147327007|OTHER||Least square mean difference|-2.2|||||TWO_SIDED|95.0|-4.0|-0.3|||||Sleep Problems Index II score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.3|-4.0|
73897049|NCT04345367|147327007|OTHER||Least square mean difference|-2.9|||||TWO_SIDED|95.0|-4.8|-1.1|||||Sleep Problems Index II score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.1|-4.8|
73897050|NCT04345367|147327007|OTHER||Least square mean difference|-1.4|||||TWO_SIDED|95.0|-3.2|0.4|||||Sleep Problems Index II score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-3.2|
73897051|NCT04345367|147327008|OTHER||Least square mean difference|-1.1|||||TWO_SIDED|95.0|-1.5|-0.8|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.8|-1.5|
73897052|NCT04345367|147327008|OTHER||Least square mean difference|-0.4|||||TWO_SIDED|95.0|-0.8|-0.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.1|-0.8|
73897053|NCT04345367|147327008|OTHER||Least square mean difference|-0.2|||||TWO_SIDED|95.0|-0.6|0.1|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-0.6|
73897054|NCT04345367|147327008|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-0.6|0.0|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.0|-0.6|
73897055|NCT04345367|147327008|OTHER||Least square mean difference|-0.2|||||TWO_SIDED|95.0|-0.5|0.1|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-0.5|
73897056|NCT04345367|147327009|OTHER||Least square mean difference|18.1|||||TWO_SIDED|95.0|10.5|25.7||||||Analysis was performed using analysis of covariance (ANCOVA) model including treatment as a main effect and baseline disease severity as covariates.||25.7|10.5|
73897057|NCT04345367|147327010|OTHER||Estimate of difference|13.7|||||TWO_SIDED|95.0|7.3|20.1|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.1|7.3|
73897058|NCT04345367|147327010|OTHER||Estimate of difference|3.9|||||TWO_SIDED|95.0|-1.6|9.4|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||9.4|-1.6|
73897059|NCT04345367|147327010|OTHER||Estimate of difference|-1.6|||||TWO_SIDED|95.0|-7.1|4.0|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||4.0|-7.1|
73897060|NCT04345367|147327010|OTHER||Estimate of difference|-2.0|||||TWO_SIDED|95.0|-7.6|3.6|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||3.6|-7.6|
73897061|NCT04345367|147327010|OTHER||Estimate of difference|-4.2|||||TWO_SIDED|95.0|-10.3|1.9|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||1.9|-10.3|
73897062|NCT00978757|147327043|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
73897063|NCT01185353|147327060|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori p-value significance threshold: 1-sided ≤0.10|Regression, Logistic|||||||<0.001
73897064|NCT01185353|147327062|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.045
73897065|NCT01185353|147327062|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.088
73897066|NCT01185353|147327062|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
73897067|NCT01185353|147327062|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
73897068|NCT01185353|147327064|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.003
73897069|NCT01185353|147327064|SUPERIORITY_OR_OTHER|||||||0.162|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.162
73897070|NCT01185353|147327064|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
73897071|NCT01185353|147327064|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
73897072|NCT01185353|147327066|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.017
73897073|NCT01185353|147327066|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.109
73897074|NCT01185353|147327066|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
73897075|NCT01185353|147327066|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
73897076|NCT01185353|147327070|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.480
73897077|NCT01185353|147327070|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.064
73897078|NCT01185353|147327070|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897079|NCT01185353|147327070|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
73897080|NCT01185353|147327070|SUPERIORITY_OR_OTHER|||||||0.116|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.116
73897081|NCT01185353|147327070|SUPERIORITY_OR_OTHER|||||||0.201|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.201
73897082|NCT01185353|147327070|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897083|NCT01185353|147327070|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.002
73897084|NCT01185353|147327072|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.003
73897085|NCT01185353|147327072|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.167
73897086|NCT01185353|147327072|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897087|NCT01185353|147327072|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
73897088|NCT01185353|147327074|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.016
73897089|NCT01185353|147327074|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.108
73897090|NCT01185353|147327074|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.008
73897091|NCT01185353|147327074|SUPERIORITY_OR_OTHER|||||||0.368|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.368
73897092|NCT01185353|147327076|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.039
73897093|NCT01185353|147327076|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.458
73897094|NCT01185353|147327076|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.008
73897095|NCT01185353|147327076|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.029
73897096|NCT01185353|147327078|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.217
73897097|NCT01185353|147327078|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.092
73897098|NCT01185353|147327078|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897099|NCT01185353|147327078|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897100|NCT01185353|147327078|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897101|NCT01185353|147327078|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.072
73897102|NCT01185353|147327078|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897103|NCT01185353|147327078|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897104|NCT01185353|147327078|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897105|NCT01185353|147327078|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.082
73897106|NCT01185353|147327078|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897107|NCT01185353|147327078|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897108|NCT01185353|147327080|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.024
73897109|NCT01185353|147327080|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.030
73897110|NCT01185353|147327080|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897111|NCT01185353|147327080|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897112|NCT01185353|147327082|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||0.120
73897113|NCT01185353|147327082|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||0.012
73897114|NCT01185353|147327082|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||<0.001
73897115|NCT01185353|147327082|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||<0.001
73897116|NCT01185353|147327084|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.409
73897117|NCT01185353|147327084|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.371
73897118|NCT01185353|147327084|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||<0.001
73897119|NCT01185353|147327084|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.007
73897120|NCT01185353|147327084|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.033
73897121|NCT01185353|147327084|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.019
73897122|NCT01185353|147327084|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||<0.001
73897123|NCT01185353|147327084|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.001
73897124|NCT01185353|147327086|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.015
73897125|NCT01185353|147327086|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.073
73897126|NCT01185353|147327086|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897127|NCT01185353|147327086|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897128|NCT01185353|147327087|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.021
73897129|NCT01185353|147327087|SUPERIORITY_OR_OTHER|||||||0.194|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.194
73897130|NCT01185353|147327087|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897131|NCT01185353|147327087|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.012
73897132|NCT01185353|147327087|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.449
73897133|NCT01185353|147327087|SUPERIORITY_OR_OTHER|||||||0.578|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.578
73897134|NCT01185353|147327087|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.140
73897135|NCT01185353|147327087|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.266
73897136|NCT01185353|147327088|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|A priori p-value significance threshold: 2-sided ≤0.10.||||||0.005
73897137|NCT01185353|147327088|SUPERIORITY_OR_OTHER|||||||0.135|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.135
73897138|NCT01185353|147327088|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
73897139|NCT01185353|147327088|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
73897140|NCT01185353|147327089|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.203
73897141|NCT01185353|147327089|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.164
73897142|NCT01185353|147327089|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.018
73897143|NCT01185353|147327089|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.097
73897144|NCT02270944|147327093|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|1.02|||||TWO_SIDED|95.0|0.79|1.32|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||To demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ia when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.32|0.79|
73897145|NCT02270944|147327094|NON_INFERIORITY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.99|||||TWO_SIDED|95.0|0.76|1.3|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes III when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.30|0.76|
73897146|NCT02270944|147327095|NON_INFERIORITY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.72|1.22|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ib when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.22|0.72|
73897147|NCT01978938|147327099|NON_INFERIORITY|The NI test was based on the lower limit of the 2-sided 95% confidence interval (CI), using the method proposed without stratification by Miettinen and Nurminen. If the lower limit of the 95% CI for the difference in Responder (clinical cure and microbiologic success) rates in the micro-ITT population exceeded -10%, then the null hypothesis was rejected and the NI of eravacycline to levofloxacin was declared.|Treatment Difference|-6.5|||||TWO_SIDED|95.0|-14.1|1.2||||||For the FDA, an NI margin of 10% was used, which was based on historical data regarding the treatment effect of antibiotics. A 10% NI margin for the Responder outcome is robust and can sufficiently confirm a clinically meaningful treatment effect of eravacycline in the treatment of cUTI.||1.2|-14.1|
73897148|NCT00095147|147327102|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-1.04|||<|0.001|TWO_SIDED|95.0|-1.42|-0.67|||ANCOVA|||The primary analysis was the comparison of abatacept versus placebo for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.67|-1.42|<0.001
73897149|NCT00095147|147327103|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-0.77|||<|0.001|TWO_SIDED|95.0|-1.14|-0.39|||ANCOVA|||Infliximab versus placebo were compared for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.39|-1.14|<0.001
73897150|NCT00095147|147327105|SUPERIORITY_OR_OTHER||Estimate of difference from placebo|20.6||||0.001|TWO_SIDED|95.0|7.7|33.6|||Chi-squared, Corrected|||Comparisons were made between ABA and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.||33.6|7.7|0.001
73897151|NCT00095147|147327105|SUPERIORITY_OR_OTHER||Estimate of difference from placebo|17.9||||0.005|TWO_SIDED|95.0|5.1|30.7|||Chi-squared, Corrected|||Comparisons were made between INF and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.||30.7|5.1|0.005
73897152|NCT00095147|147327107|SUPERIORITY_OR_OTHER||Difference from placebo|-0.38|||<|0.001|TWO_SIDED|95.0|-0.53|-0.23|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.23|-0.53|<0.001
73897153|NCT00095147|147327107|SUPERIORITY_OR_OTHER||Difference from placebo|-0.3|||<|0.001|TWO_SIDED|95.0|-0.45|-0.15|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.15|-0.45|<0.001
73897154|NCT00095147|147327109|SUPERIORITY_OR_OTHER||Difference from placebo (PCS)|4.02|||<|0.001|TWO_SIDED|95.0|1.92|6.12|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||6.12|1.92|<0.001
73897155|NCT00095147|147327109|SUPERIORITY_OR_OTHER||Difference from placebo (MCS)|3.51||||0.004|TWO_SIDED|95.0|1.1|5.91|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.91|1.10|0.004
73897156|NCT00095147|147327109|SUPERIORITY_OR_OTHER||Difference from placebo (PCS)|3.32||||0.002|TWO_SIDED|95.0|1.25|5.4|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.40|1.25|0.002
73897157|NCT00095147|147327109|SUPERIORITY_OR_OTHER||Difference from placebo (MCS)|2.68||||0.027|TWO_SIDED|95.0|0.31|5.05|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.05|0.31|0.027
73897158|NCT01227629|147327202|SUPERIORITY_OR_OTHER|||||||0.0357||95.0|||||Kruskal-Wallis|||Group comparison of differences from baseline to last available value||||0.0357
73897159|NCT01227629|147327203|SUPERIORITY_OR_OTHER|||||||0.26711||95.0|||||Kruskal-Wallis|||Group comparison of differences from baseline to week 12||||0.26711
73897160|NCT01250496|147327254|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.45||||0.04|TWO_SIDED|95.0|0.2|0.98||No adjustment for multiple comparisons was performed. The threshold for statistical significance was \< 0.05|Chi-squared|||null hypothesis: aminophylline administration does not reduce the incidence of the primary endpoint as compared to placebo. The chi-square test was used to compare event rate between the study arm.||0.98|0.2|0.04
73897161|NCT01250496|147327255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.2|0.7||P value is not adjusted for multiple comparisons.|Chi-squared|||"null hypothesis: the rate of regadenoson adverse effects (global symptomatic burden) in the aminophylline and placebo group are not statistically different.~The chi-square test was used for comparison."||0.7|0.2|< 0.001
73897162|NCT01425463|147327285|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the investigational drug (Ferrous (II) Glycine Sulphate Complex) to the reference drug (Polyferose) was concluded if the lower limit of the two-sided 95 % confidence interval was greater than -7.0 g/L.|LS-Mean of ANCOVA|-2.19|||||TWO_SIDED|95.0|-8.47|4.09||||||||4.09|-8.47|
73897163|NCT01122264|147327314|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.66|||<|0.001|TWO_SIDED|97.3|0.51|0.85||P-value: Tadalafil Once a Day versus Sildenafil Citrate On Demand treatment groups. Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||0.85|0.51|<0.001
73897164|NCT01122264|147327314|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.49|||<|0.001|TWO_SIDED|97.3|0.37|0.65||P-value: Tadalafil On Demand versus Sildenafil Citrate On Demand treatment groups. Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||0.65|0.37|<0.001
73897165|NCT01122264|147327314|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.32||||0.033|TWO_SIDED|95.0|1.02|1.71||P-value: Tadalafil On Demand versus Tadalafil Once a Day treatment groups using Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||1.71|1.02|0.033
73897166|NCT02558829|147327332|OTHER|Positive percent agreement \[%\] = 100% x A/(A+C). A= MAC outcome positive and ITT outcome positive; C = MAC outcome negative and ITT positive|CI (Clopper Pearson): positive agreement|74.32|||||TWO_SIDED|95.0|62.84|83.78||||||The estimated percentages of the agreements and the two-sided 95% confidence interval (or one-sided 97.5% confidence interval) of the percent agreement based on Clopper-Pearson are presented. The performance of the MAC (cut-off point 2.8 ng/mL) was considered to be acceptable if the lower bound of the two-sided 95% CI (or lower bound of the one-sided 97.5% CI) was 75% or higher for 'percent negative agreement', and 70% or higher for the 'percent positive agreement'.||83.78|62.84|
73897167|NCT02558829|147327332|OTHER|Negative percent agreement \[%\] = 100% x D/(B+D). D = MAC outcome negative and ITT outcome negative; B = MAC outcome positive and ITT outcome negative|CI (Clopper Pearson): negative agreement|93.94|||||TWO_SIDED|95.0|85.2|98.32||||||Please refer to Statistical Analysis 1.||98.32|85.20|
73897168|NCT02558829|147327333|OTHER|The secondary diagnostic accuracy measure was 'percent overall agreement'.|overall agreement|83.57|||||TWO_SIDED|95.0|76.38|89.29||||||This variable was analyzed using the same methodology described for the analyses for the primary efficacy variables. in the below, the results for Step 1 (peak GH level among all post baseline samples) are presented.||89.29|76.38|
73897169|NCT02558829|147327335|OTHER||Mean Difference (Final Values)|-2.9|STANDARD_DEVIATION|6.38|||TWO_SIDED|||||||||"Pre/post dose comparison of ECGs was done for both GHSTs. During the GHSTs, ECGs were measured at pre-dose (up to 15 min before) and 60 minutes post-dose. Furthermore, ECGs were measured at screening and at End-of-Study (EOS) Visit.~Calculations were done from two time points: baseline and 60 min post-dose. Baseline is either the screening or pre-dose value."||||
73897170|NCT02558829|147327335|OTHER|Please refer to Statistical Analysis 1 for this secondary outcome measure.|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|8.15|||TWO_SIDED|||||||||||||
73897171|NCT02558829|147327336|OTHER|Sensitivity is the probability that the test result is positive given the subject has the disease (for the purpose of this analysis, all group A subjects were assumed to have AGHD, but none of the group D subjects). Sensitivity (SS) was estimated by: SS = TP/(TP+FN). TP=True AGHD positive subject; FN=False AGHD negative subject.|CI (Clopper Pearson)|0.87|||||TWO_SIDED|95.0|0.72|0.96||||||Sensitivity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.||0.96|0.72|
73897172|NCT02558829|147327336|OTHER|"Specificity is the probability that the test result is negative given the subject does not have the disease.~Specificity (SP) was estimated by: SP = TN/(TN+FP). TN = True AGHD negative Subjects; FP = False AGHD positive subjects."|CI (Clopper Pearson)|0.96|||||TWO_SIDED|95.0|0.8|1.0||||||Specificity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.||1.00|0.80|
73897173|NCT02558829|147327337|OTHER|Positive percent agreement \[%\] = 100% x A/(A+C). A= test outcome positive for MAC core study part and positive for MAC repeatability extension; C = test outcome positive for MAC core study part and negative for MAC repeatability extension.|CI (Clopper Pearson): positive agreement|88.89|||||TWO_SIDED|95.0|65.29|98.62||||||Please refer to Statistical Analysis 1 for this outcome.||98.62|65.29|
73897174|NCT02558829|147327337|OTHER|Negative percent agreement \[%\] = 100% x D/(B+D). D = test outcome negative for MAC core study part and negative for MAC repeatability extension; B = test outcome negative for MAC core study part and positive for MAC repeatability extension|CI (Clopper Pearson): negative agreement|100.0|||||TWO_SIDED|95.0|79.41|100.0||||||Amendment no 1 had been issued for selected sites in Europe to obtain exploratory data on the repeatability of the MAC in a subset of subjects that had completed the core study.||100.00|79.41|
73897175|NCT00097981|147327364|SUPERIORITY_OR_OTHER|||||||0.49|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3||||||0.49
73897176|NCT00097981|147327365|SUPERIORITY_OR_OTHER|||||||0.42|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3||||||0.42
73897177|NCT00097981|147327366|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Log Rank|||||||0.42
73897178|NCT00097981|147327367|SUPERIORITY_OR_OTHER|||||||0.5162||95.0|||||Log Rank|||||||0.5162
73897179|NCT00097981|147327368|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.93|TWO_SIDED|95.0|0.529|1.797|||Log Rank|Stratified log-rank test||||1.797|0.529|0.93
73897180|NCT00791973|147327371|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon signed-rank test|||||||0.33
73897181|NCT00791973|147327372|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon signed-rank test|||||||0.14
73897182|NCT01369329|147327435|SUPERIORITY_OR_OTHER|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.002
73897183|NCT01369329|147327435|SUPERIORITY_OR_OTHER|||||||0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.003
73897184|NCT01369329|147327436|SUPERIORITY_OR_OTHER|||||||0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.003
73897185|NCT01369329|147327436|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
73897186|NCT01369329|147327437|SUPERIORITY_OR_OTHER|||||||0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.001
73897187|NCT01369329|147327437|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
73897188|NCT01369329|147327438|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
73897189|NCT01369329|147327438|SUPERIORITY_OR_OTHER|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.002
73897190|NCT01369329|147327439|SUPERIORITY_OR_OTHER|||||||0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.009
73897191|NCT01369329|147327439|SUPERIORITY_OR_OTHER|||||||0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.001
73897192|NCT01101308|147327440|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|102.0|||||TWO_SIDED|90.0|97.51|107.27|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||107.27|97.51|
73897193|NCT01101308|147327441|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|97.19|103.0|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||103.00|97.19|
73897194|NCT01101308|147327442|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|97.14|102.99|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||102.99|97.14|
73897195|NCT04121078|147327482|EQUIVALENCE|Point estimate and its 90% confidence interval (CI) were calculated for Treatment B to Treatment A ratio of geometric means for Cmax based on the mixed-effect model of log-transformed Cmax with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for Cmax. No adjustments were made for multiplicity.|Geometric Mean Ratio|6.24|||||TWO_SIDED|90.0|4.62|8.42||||||||8.42|4.62|
73897196|NCT04121078|147327483|EQUIVALENCE|Point estimate and its 90% CI were calculated for Treatment B to Treatment A ratio of geometric means for AUC∞ based on the mixed-effect model of log-transformed AUC∞ with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for AUC∞. No adjustments were made for multiplicity.|Geometric Mean Ratio|5.16|||||TWO_SIDED|90.0|4.25|6.25||||||||6.25|4.25|
73897197|NCT04121078|147327484|EQUIVALENCE|Point estimate and its 90% CI were calculated for Treatment B to Treatment A ratio of geometric means for AUClast based on the mixed-effect model of log-transformed AUClast with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for AUClast. No adjustments were made for multiplicity.|Geometric Mean Ratio|5.21|||||TWO_SIDED|90.0|4.29|6.32||||||||6.32|4.29|
73897198|NCT03222492|147327499|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
73897199|NCT03222492|147327499|SUPERIORITY|||||||0.444||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.444
73897200|NCT03222492|147327500|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
73897201|NCT03222492|147327500|SUPERIORITY|||||||0.4||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.400
73897202|NCT03222492|147327501|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
73897203|NCT03222492|147327501|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
73897204|NCT03222492|147327501|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
73897205|NCT03222492|147327501|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
73897206|NCT03222492|147327501|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||1.000
73897207|NCT03222492|147327501|SUPERIORITY|||||||0.5||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.500
73897208|NCT03222492|147327502|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
73897209|NCT03222492|147327502|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
73897210|NCT03222492|147327503|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
73897211|NCT03222492|147327503|SUPERIORITY|||||||0.467||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.467
73897212|NCT03222492|147327504|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||1.000
73897213|NCT03222492|147327504|SUPERIORITY|||||||0.4||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.400
73897214|NCT03222492|147327505|SUPERIORITY|||||||0.464||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.464
73897215|NCT03222492|147327505|SUPERIORITY|||||||0.5||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.500
73897216|NCT03222492|147327505|SUPERIORITY|||||||0.25||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.250
73897217|NCT03222492|147327505|SUPERIORITY|||||||0.167||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.167
73897218|NCT03222492|147327505|SUPERIORITY|||||||0.083||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.083
73897219|NCT03222492|147327505|SUPERIORITY|||||||0.083||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.083
73897220|NCT03222492|147327506|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
73897221|NCT03222492|147327506|SUPERIORITY|||||||0.429||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.429
73897222|NCT03222492|147327507|SUPERIORITY|||||||0.286||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.286
73897223|NCT03222492|147327507|SUPERIORITY|||||||0.067||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.067
73897224|NCT03222492|147327508|SUPERIORITY|||||||0.1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.100
73897225|NCT03222492|147327509|SUPERIORITY|||||||0.1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.100
73897226|NCT03222492|147327520|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
73897227|NCT03222492|147327520|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
73897228|NCT03222492|147327521|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||||||1.000
73897229|NCT03222492|147327521|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
73897230|NCT01054183|147327522|NON_INFERIORITY_OR_EQUIVALENCE|powered for 62 patients||||||0.57||95.0|||||z test, two-sided|||Null hypothesis: the proportion of successful 1st intubation attempt is the same for both groups||||0.57
73897231|NCT01054183|147327523|NON_INFERIORITY_OR_EQUIVALENCE|powered for 62 patients||||||0.002||95.0|||||z test, two-sided|||Null hypothesis: overall successful intubation rate is the same for both groups.||||0.002
73897232|NCT02189954|147327531|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
73897233|NCT02189954|147327531|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mann Whitney U|||||||<0.05
73897234|NCT02775240|147327534|OTHER||Ratio of geometric means|1.248|||||TWO_SIDED|90.0|1.13|1.378|||Linear mixed effects model||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Digoxin||1.378|1.130|
73897235|NCT02775240|147327535|OTHER||Ratio of geometric means|0.944|||||TWO_SIDED|90.0|0.778|1.144|||Linear mixed effects model|||Comparison of Treatment B over Treatment A for Cmax of Dextromethorphan||1.144|0.778|
73897236|NCT02775240|147327536|OTHER||Ratio of geometric means|0.943|||||TWO_SIDED|90.0|0.883|1.007|||Linear mixed effects model||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Dextrorphan||1.007|0.883|
73897237|NCT02775240|147327542|OTHER||Ratio of geometric means|1.206|||||TWO_SIDED|90.0|1.099|1.324|||Linear mixed effects model||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Digoxin||1.324|1.099|
73897238|NCT02775240|147327544|OTHER||Ratio of geometric means|0.971|||||TWO_SIDED|90.0|0.943|0.999|||Linear mixed effects model||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Dextrorphan||0.999|0.943|
73897239|NCT02775240|147327545|OTHER||Ratio of geometric means|1.179|||||TWO_SIDED|90.0|1.08|1.287|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Digoxin||1.287|1.080|
73897240|NCT02775240|147327546|OTHER||Ratio of geometric means|0.882|||||TWO_SIDED|90.0|0.696|1.118|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast of Dextromethorphan||1.118|0.696|
73897241|NCT02775240|147327547|OTHER||Ratio of geometric means|0.973|||||TWO_SIDED|90.0|0.949|0.998|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Dextrorphan||0.998|0.949|
73897242|NCT02775240|147327548|OTHER||Ratio of geometric means|0.905|||||TWO_SIDED|90.0|0.721|1.138|||Linear mixed effects model||Log-transformed AUClast ratio values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Dextromethorphan/Dextrorphan (Parent/Metabolite) AUClast ratio||1.138|0.721|
73897243|NCT01755026|147327579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|191.0|STANDARD_ERROR_OF_MEAN|166.01|<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
73897244|NCT02184624|147327580|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical comparison for categories Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
73897245|NCT02184624|147327580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
73897246|NCT02184624|147327580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||<0.001
73897247|NCT02184624|147327580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
73897248|NCT02184624|147327580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||<0.001
73897249|NCT02184624|147327581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
73897250|NCT02184624|147327581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
73897251|NCT02184624|147327581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||<0.001
73897252|NCT02184624|147327581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
73897253|NCT02184624|147327581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||<0.001
73897254|NCT02184624|147327582|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||0.480
73897255|NCT02184624|147327582|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||0.044
73897256|NCT02184624|147327582|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||0.025
73897257|NCT02184624|147327582|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
73897258|NCT02184624|147327582|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||0.014
73897259|NCT02184624|147327583|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
73897260|NCT02184624|147327583|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
73897261|NCT02184624|147327583|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||0.002
73897262|NCT02184624|147327583|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||0.001
73897263|NCT02184624|147327583|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||0.003
73897264|NCT02184624|147327584|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for DISKUS/ACCUHALER inhaler|Wilcoxon signed rank test|||||||<0.001
73897265|NCT02184624|147327584|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for MDI inhaler|Wilcoxon signed rank test|||||||<0.001
73897266|NCT02184624|147327584|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for TURBUHALER inhaler|Wilcoxon signed rank test|||||||<0.001
73897267|NCT02184624|147327584|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for HANDIHALER inhaler|Wilcoxon signed rank test|||||||<0.001
73897268|NCT02184624|147327584|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for BREEZHALER inhaler|Wilcoxon signed rank test|||||||<0.001
73897269|NCT02184624|147327585|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
73897270|NCT02184624|147327585|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
73897271|NCT02184624|147327585|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
73897272|NCT02184624|147327585|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
73897273|NCT02184624|147327585|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
73897274|NCT02184624|147327586|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
73897275|NCT02184624|147327586|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
73897276|NCT02184624|147327586|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
73897277|NCT02184624|147327586|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
73897278|NCT02184624|147327586|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
73897279|NCT03259620|147327599|SUPERIORITY|||||||0.2587|||||||Cochran-Mantel-Haenszel|||||||0.2587
73897280|NCT02081859|147327623|OTHER|||||||0.41|||||||Chi-squared|||||||0.41
73897281|NCT02081859|147327624|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
73897282|NCT02285062|147327625|SUPERIORITY||Hazard Ratio (HR)|0.849||||0.2864|TWO_SIDED|95.0|0.632|1.14|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors|||1.140|0.632|0.2864
73897283|NCT02285062|147327626|SUPERIORITY||Hazard Ratio (HR)|1.038||||0.7294|TWO_SIDED|95.0|0.802|1.344|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.|||1.344|0.802|0.7294
73897284|NCT02285062|147327627|SUPERIORITY||Hazard Ratio (HR)|0.965||||0.876|TWO_SIDED|95.0|0.716|1.3|||Log Rank|Log-rank test stratified by 3 factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.|||1.300|0.716|0.8760
73897285|NCT02285062|147327628|SUPERIORITY|||||||0.2933||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65)|Cochran-Mantel-Haenszel|||||||0.2933
73897286|NCT02285062|147327629|SUPERIORITY|||||||0.9964||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65)|Cochran-Mantel-Haenszel|||||||0.9964
73897287|NCT02285062|147327630|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.2143|TWO_SIDED|95.0|0.521|1.157|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|HR was derived from COX model adjusting for the 3 stratification factors mentioned above.|||1.157|0.521|0.2143
73897288|NCT02285062|147327631|SUPERIORITY||Hazard Ratio (HR)|1.167||||0.315||95.0|0.856|1.59|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|HR is derived from Cox model|||1.590|0.856|0.3150
73897289|NCT00492063|147327651|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in adults.||3|-3|
73897290|NCT00492063|147327651|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in adults.||2|-1|
73897291|NCT00492063|147327651|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in adults.||3|-3|
73897292|NCT00492063|147327651|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in the elderly population.||3|-4|
73897293|NCT00492063|147327651|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||TWO_SIDED|95.0|-2.0|1.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in the elderly population.||1|-2|
73897294|NCT00492063|147327651|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in the elderly population.||4|-2|
73897295|NCT00492063|147327652|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|2.0|||||TWO_SIDED|95.0|-3.0|7.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.||7|-3|
73897296|NCT00492063|147327652|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.||4|-6|
73897297|NCT00492063|147327652|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.||8|0|
73897298|NCT00492063|147327652|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|0.0|||||TWO_SIDED|95.0|-6.0|5.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.||5|-6|
73897299|NCT00492063|147327652|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|3.0|||||TWO_SIDED|95.0|-2.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.||8|-2|
73897300|NCT00492063|147327652|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|6.0|||||TWO_SIDED|95.0|2.0|11.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.||11|2|
